[The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions]
[The Regulatory Plan Part 2]
[From the U.S. Government Printing Office, www.gpo.gov]



[[Page 72413]]


                                                                DEPARTMENT OF AGRICULTURE
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
1                National Organic Program: Add Standards for the Organic Certification of Wild Captured Aquatic           0581-AB97       Prerule Stage
                 Animals (TM-01-08)
2                National Dairy Promotion and Research Program (DA-02-03)                                                    0581-AC16    Proposed Rule
                                                                                                                                                  Stage
3                Livestock Mandatory Reporting Program-Lamb Amendment (LS-01-08)                                          0581-AB98    Final Rule Stage
4                Mandatory Country of Origin Labeling of Beef, Pork, Lamb, Fish, Perishable Agricultural                     0581-AC26 Final Rule Stage
                 Commodities, and Peanuts (LS-03-04)
5                Chronic Wasting Disease in Elk and Deer; Interstate Movement Restrictions and Payment of Indemnity       0579-AB35       Proposed Rule
                                                                                                                                                  Stage
6                Bovine Spongiform Encephalopathy: Minimal Risk Regions and Importation of Commodities                    0579-AB73       Proposed Rule
                                                                                                                                                  Stage
7                Foot-and-Mouth Disease; Payment of Indemnity                                                             0579-AB34    Final Rule Stage
8                Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological            0579-AB47    Final Rule Stage
                 Agents and Toxins
9                Multi-Family Housing (MFH) Reinvention                                                                      0575-AC13 Final Rule Stage
10               Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions to WIC          0584-AD39       Prerule Stage
                 Food Packages
11               Commodity Supplemental Food Program (CSFP): Plain Language, Program Accountability, and Program             0584-AC84    Proposed Rule
                 Flexibility                                                                                                                      Stage
12               Food Stamp Program: Simplification and State Flexibility                                                 0584-AD22       Proposed Rule
                                                                                                                                                  Stage
13               FSP: High Performance Bonuses                                                                            0584-AD29       Proposed Rule
                                                                                                                                                  Stage
14               FSP: Eligibility and Certification Provisions of the Farm Security and Rural Investment Act of 2002      0584-AD30       Proposed Rule
                                                                                                                                                  Stage
15               FSP: Employment and Training Program Provisions of the Farm Security and Rural Investment Act of         0584-AD32       Proposed Rule
                 2002                                                                                                                             Stage
16               Senior Farmers' Market Nutrition Program (SFMNP)                                                         0584-AD35       Proposed Rule
                                                                                                                                                  Stage
17               FSP: Discretionary Quality Control Provisions of Title IV of Public Law 107-171                          0584-AD37       Proposed Rule
                                                                                                                                                  Stage
18               Child and Adult Care Food Program: Improving Management and Program Integrity                               0584-AC24 Final Rule Stage
19               Food Stamp Program: Vehicle and Maximum Excess Shelter Expense Deduction Provisions of Public Law        0584-AD13    Final Rule Stage
                 106-387
20               FSP: Non-Discretionary Quality Control Provisions of Title IV of Public Law 107-171                      0584-AD31    Final Rule Stage
21               Performance Standards for Bacon                                                                             0583-AC49    Proposed Rule
                                                                                                                                                  Stage
22               Egg and Egg Products Inspection Regulations                                                                 0583-AC58    Proposed Rule
                                                                                                                                                  Stage
23               Elimination of Chilling Time and Temperature Requirements for Ready-To-Cook Poultry                         0583-AC87    Proposed Rule
                                                                                                                                                  Stage
24               Emergency Regulations To Prevent Meat Food and Meat Products That May Contain the BSE Agent From            0583-AC88    Proposed Rule
                 Entering Commerce                                                                                                                Stage
25               Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery Systems                       0583-AD00       Proposed Rule
                                                                                                                                                  Stage
26               Performance Standards for Ready-To-Eat Meat and Poultry Products                                            0583-AC46 Final Rule Stage
27               Nutrition Labeling of Ground or Chopped Meat and Poultry Products and Single-Ingredient Products            0583-AC60 Final Rule Stage
28               National Forest System Land Management Planning                                                          0596-AB86    Final Rule Stage
29               National Security Emergency                                                                              0570-AA48       Proposed Rule
                                                                                                                                                  Stage
30               Renewable Energy Systems and Energy Efficiency Improvements                                              0570-AA50       Proposed Rule
                                                                                                                                                  Stage
31               Conservation Security Program                                                                            0578-AA36       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 72414]]


                                                                 DEPARTMENT OF COMMERCE
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
32               Amendment 13 to the Northeast Multispecies Fishery Management Plan (FMP)                                 0648-AN17       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                  DEPARTMENT OF DEFENSE
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
33               Programmatic Regulations for the Comprehensive Everglades Restoration Plan                               0710-AA49    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                 DEPARTMENT OF EDUCATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
34               Reauthorization of the Individuals With Disabilities Education Act                                       1820-AB54       Prerule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                  DEPARTMENT OF ENERGY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
35               Energy Efficiency Standards for Residential Furnaces, Boilers, and Mobile Home Furnaces                  1904-AA78       Prerule Stage
36               Energy Efficiency Standards for Electric Distribution Transformers                                       1904-AB08       Prerule Stage
37               Energy Efficiency Standards for Commercial Central Air Conditioning Units and Heat Pumps Rated 65-       1904-AB09       Prerule Stage
                 240 kBtus/Hr
38               Worker Safety and Health                                                                                 1901-AA99       Proposed Rule
                                                                                                                                                  Stage
39               Radiation Protection of the Public and the Environment                                                   1901-AA38    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                         DEPARTMENT OF HEALTH AND HUMAN SERVICES
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
40               Health Insurance Portability and Accountability Act--Enforcement                                         0991-AB29       Proposed Rule
                                                                                                                                                  Stage
41               Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical Community-Based          0930-AA10       Proposed Rule
                 Facilities for Children and Youth                                                                                                Stage
42               Prevention of Salmonella Enteritidis in Shell Eggs                                                          0910-AC14    Proposed Rule
                                                                                                                                                  Stage
43               Exception From General Requirements for Informed Consent; Request for Comments and Information              0910-AC25    Proposed Rule
                                                                                                                                                  Stage
44               Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs                                   0910-AC35    Proposed Rule
                                                                                                                                                  Stage
45               Definition of ``Serious Adverse Health Consequences'' Under the Public Health Security and               0910-AF06       Proposed Rule
                 Bioterrorism Preparedness and Response Act of 2002                                                                               Stage
46               Use of Ozone-Depleting Substances: Removal of Essential Use Designation; Albuterol                       0910-AF18       Proposed Rule
                                                                                                                                                  Stage
47               Labeling for Human Prescription Drugs; Revised Format                                                    0910-AA94    Final Rule Stage
48               Safety Reporting Requirements for Human Drug and Biological Products                                     0910-AA97    Final Rule Stage
49               CGMP for Blood and Blood Components: Notification of Consignees and Transfusion Recipients               0910-AB76    Final Rule Stage
                 Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback)

[[Page 72415]]

 
50               Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and        0910-AB88    Final Rule Stage
                 Dietary Supplements
51               Bar Code Label Requirements for Human Drug Products and Blood                                               0910-AC26 Final Rule Stage
52               Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security           0910-AC38 Final Rule Stage
                 and Bioterrorism Preparedness and Response Act of 2002
53               Establishment and Maintenance of Records Pursuant to the Public Health Security and Bioterrorism            0910-AC39 Final Rule Stage
                 Preparedness and Response Act of 2002
54               Smallpox Vaccine Injury Compensation Program: Administrative Implementation                              0906-AA61    Final Rule Stage
55               End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P)                                      0938-AG82       Proposed Rule
                                                                                                                                                  Stage
56               Hospital Conditions of Participation: Requirements for Approval and Reapproval of Transplant             0938-AH17       Proposed Rule
                 Centers To Perform Organ Transplants (CMS-3835-P)                                                                                Stage
57               Organ Procurement Organization Conditions for Coverage (CMS-3064-P)                                      0938-AK81       Proposed Rule
                                                                                                                                                  Stage
58               Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities That Provide            0938-AL26       Proposed Rule
                 Inpatient or Residential Care (CMS-2130-P)                                                                                       Stage
59               Prospective Payment System for Inpatient Psychiatric Facilities FY 2004 (CMS-1213-F)                     0938-AL50       Proposed Rule
                                                                                                                                                  Stage
60               Hospital Patients' Rights CoP-Standard Safety Compliance Committees (CMS-3120-P)                         0938-AM39       Proposed Rule
                                                                                                                                                  Stage
61               Use of Restraint and Seclusion in Residential Treatment Facilities Providing Inpatient Psychiatric       0938-AJ96    Final Rule Stage
                 Services to Individuals Under Age 21 (CMS-2065-F)
62               Revisions to the Medicare Appeals Process (CMS-4004-FC)                                                  0938-AL67    Final Rule Stage
63               Revisions to the Appeals Process for Initial Claim Determinations (CMS-4064-F)                           0938-AM73    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                       DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
64               Treble Damages for Failure To Engage in Loss Mitigation (FR-4553)                                           2501-AC66    Proposed Rule
                                                                                                                                                  Stage
65               The Secretary of HUD's Regulation of Fannie Mae and Freddie Mac (FR-4790)                                   2501-AC92    Proposed Rule
                                                                                                                                                  Stage
66               American Dream Downpayment Initiative (FR-4832)                                                             2501-AC93 Final Rule Stage
67               Disposition of HUD-Owned Single Family Assets in Asset Control Areas (FR-4471)                           2502-AH40       Proposed Rule
                                                                                                                                                  Stage
68               Revisions to FHA Credit Watch Termination Initiative (FR-4625)                                           2502-AH60    Final Rule Stage
69               Lender Accountability for Appraisals (FR-4722)                                                           2502-AH78    Final Rule Stage
70               Community Development Block Grant Program Revision of CDBG Eligibility and National Objective               2506-AC12    Proposed Rule
                 Regulations (FR-4699)                                                                                                            Stage
71               Capital Fund Program (FR-4880)                                                                              2577-AC50    Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                               DEPARTMENT OF THE INTERIOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
72               Endangered Species and Pesticide Regulation                                                              1018-AI95       Proposed Rule
                                                                                                                                                  Stage
73               Snowmobile Regulations for Yellowstone and Grand Teton National Parks and JDR Parkway                    1024-AD11    Final Rule Stage
74               Relief or Reduction in Royalty Rates--Deep Gas Provisions                                                1010-AD01    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 72416]]


                                                                  DEPARTMENT OF JUSTICE
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
75               Nondiscrimination on the Basis of Disability in Public Accommodations and Commercial Facilities          1190-AA44       Proposed Rule
                                                                                                                                                  Stage
76               Nondiscrimination on the Basis of Disability in State and Local Government Services                      1190-AA46       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                   DEPARTMENT OF LABOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
77               Family and Medical Leave Act of 1993                                                                     1215-AB35       Proposed Rule
                                                                                                                                                  Stage
78               Child Labor Regulations, Orders, and Statements of Interpretation (ESA/W-H)                              1215-AA09    Final Rule Stage
79               Defining and Delimiting the Term ``Any Employee Employed in a Bona Fide Executive, Administrative,       1215-AA14    Final Rule Stage
                 or Professional Capacity'' (ESA/W-H)
80               Trade Adjustment Assistance for Workers                                                                  1205-AB32       Proposed Rule
                                                                                                                                                  Stage
81               Labor Certification Process for the Permanent Employment of Aliens in the United States                  1205-AA66    Final Rule Stage
82               Senior Community Service Employment Program                                                              1205-AB28    Final Rule Stage
83               Rulemaking Relating to Termination of Abandoned Individual Account Plans                                 1210-AA97       Proposed Rule
                                                                                                                                                  Stage
84               Regulations Implementing the Health Care Access, Portability, and Renewability Provisions of the         1210-AA54    Final Rule Stage
                 Health Insurance Portability and Accountability Act of 1996
85               Rulemaking Relating to Notice Requirements for Continuation of Health Care Coverage                      1210-AA60    Final Rule Stage
86               Prohibiting Discrimination Against Participants and Beneficiaries Based on Health Status                 1210-AA77    Final Rule Stage
87               Asbestos Exposure Limit                                                                                  1219-AB24       Proposed Rule
                                                                                                                                                  Stage
88               Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners                              1219-AB29    Final Rule Stage
89               Occupational Exposure to Hexavalent Chromium (Preventing Occupational Illness: Chromium)                 1218-AB45       Prerule Stage
90               Occupational Exposure to Crystalline Silica                                                              1218-AB70       Prerule Stage
91               Assigned Protection Factors: Amendments to the Final Rule on Respiratory Protection                      1218-AA05    Final Rule Stage
92               Fire Protection in Shipyard Employment (Part 1915, Subpart P) (Shipyards: Fire Safety)                   1218-AB51    Final Rule Stage
93               Standards Improvement (Miscellaneous Changes) for General Industry, Marine Terminals, and                1218-AB81    Final Rule Stage
                 Construction Standards (Phase II)
94               Uniformed Services Employment and Reemployment Rights Act Regulations                                    1293-AA09       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                              DEPARTMENT OF TRANSPORTATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
95               Computer Reservations System Regulations Comprehensive Review                                               2105-AC65 Final Rule Stage
96               Flight Simulation Device Qualification                                                                   2120-AH07    Final Rule Stage
97               Reforming the Automobile Fuel Economy Standards Program                                                  2127-AJ17       Prerule Stage
98               Side Impact Protection Upgrade--Standard 214                                                             2127-AJ10       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                               DEPARTMENT OF THE TREASURY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
99               Revision of Brewery Regulations and Issuance of Regulations for Taverns on Brewery Premises              1513-AA02       Proposed Rule
                 (Brewpubs)                                                                                                                       Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 72417]]


                                                             DEPARTMENT OF VETERANS AFFAIRS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
100              Enrollment-Provision of Hospital and Outpatient Care to Veterans-Subpriorities of Priority               2900-AL51    Final Rule Stage
                 Categories 7 and 8 and Enrollment Level Decision
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             ENVIRONMENTAL PROTECTION AGENCY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
101              Endocrine Disruptor Screening Program; Priority Setting Criteria                                         2070-AD59       Prerule Stage
102              Electric Utility Steam Generating Unit MACT Regulation                                                   2060-AJ65       Proposed Rule
                                                                                                                                                  Stage
103              Implementation Rule for PM-2.5 NAAQS                                                                     2060-AK74       Proposed Rule
                                                                                                                                                  Stage
104              Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Allowables      2060-AL75       Proposed Rule
                 Plantwide Applicability Limit (PAL), Aggregation, and Debottlenecking                                                            Stage
105              Lead-Based Paint Activities; Training and Certification for Renovation and Remodeling                       2070-AC83    Proposed Rule
                                                                                                                                                  Stage
106              Pesticides; Emergency Exemption Process Revisions                                                        2070-AD36       Proposed Rule
                                                                                                                                                  Stage
107              Acceptability of Research Using Human Subjects                                                           2070-AD57       Proposed Rule
                                                                                                                                                  Stage
108              Endocrine Disrupter Screening Program; Implementing the Screening and Testing Phase                      2070-AD61       Proposed Rule
                                                                                                                                                  Stage
109              NESHAPS: Standards for Hazardous Air Pollutants for Hazardous Waste Combustors                           2050-AE01       Proposed Rule
                                                                                                                                                  Stage
110              Standards for the Management of Coal Combustion Wastes Generated by Commercial Electric Power            2050-AE81       Proposed Rule
                 Producers                                                                                                                        Stage
111              Increase Metals Reclamation From F006 Waste Streams                                                      2050-AE97       Proposed Rule
                                                                                                                                                  Stage
112              Standards and Practices for Conducting ``All Appropriate Inquiry''                                       2050-AF04       Proposed Rule
                                                                                                                                                  Stage
113              Regulatory Amendments to the F019 Hazardous Waste Listing To Exclude the Wastewater Treatment            2050-AG15       Proposed Rule
                 Sludges From the Chemical Conversion Coating Process (Zinc Phosphating) of Automobile Bodies of                                  Stage
                 Aluminum
114              Watershed Rule: Total Maximum Daily Load (TMDL) Program Revisions                                        2040-AD82       Proposed Rule
                                                                                                                                                  Stage
115              NESHAP: Plywood and Composite Wood Products                                                              2060-AG52    Final Rule Stage
116              NESHAP: Reciprocating Internal Combustion Engine                                                         2060-AG63    Final Rule Stage
117              NESHAP: Industrial, Commercial, and Institutional Boilers and Process Heaters                            2060-AG69    Final Rule Stage
118              NESHAP: Surface Coating of Automobiles and Light-Duty Trucks                                             2060-AG99    Final Rule Stage
119              Implementation Rule for 8-hour Ozone NAAQS                                                               2060-AJ99    Final Rule Stage
120              Control of Emissions of Air Pollution From Nonroad Diesel Engines and Fuel                               2060-AK27    Final Rule Stage
121              Hazardous Waste Manifest Regulation                                                                      2050-AE21    Final Rule Stage
122              Management of Cement Kiln Dust (CKD)                                                                     2050-AE34    Final Rule Stage
123              Standardized Permit for RCRA Hazardous Waste Management Facilities                                       2050-AE44    Final Rule Stage
124              Office of Solid Waste Burden Reduction Initiative                                                        2050-AE50    Final Rule Stage
125              Recycling of Cathode Ray Tubes (CRTs) and Mercury-Containing Equipment: Changes to Hazardous Waste       2050-AE52    Final Rule Stage
                 Regulations
126              National Primary Drinking Water Regulations: Groundwater Rule                                            2040-AA97    Final Rule Stage
127              National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water Treatment Rule           2040-AD37    Final Rule Stage
128              National Primary Drinking Water Regulations: Stage 2 Disinfection Byproducts Rule                        2040-AD38    Final Rule Stage
129              Effluent Guidelines and Standards for the Construction and Development Industry                          2040-AD42    Final Rule Stage
130              Minimizing Adverse Environmental Impact From Cooling Water Intake Structures at Existing Facilities      2040-AD62    Final Rule Stage
                 Under Section 316(b) of the Clean Water Act, Phase 2
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 72418]]


                                                         EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
131              Coordination of Retiree Health Benefits With Medicare and State Health Benefits                          3046-AA72    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                      NATIONAL ARCHIVES AND RECORDS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
132              Federal Records Management                                                                               3095-AB16       Prerule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                          PENSION BENEFIT GUARANTY CORPORATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
133              Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets                          1212-AA55       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                RAILROAD RETIREMENT BOARD
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
134              Electronic Filing of Applications and Claims for Benefits Under the Railroad Unemployment Insurance      3220-AB57       Proposed Rule
                 Act                                                                                                                              Stage
135              Application for Annuity or Lump Sum                                                                      3220-AB55    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                              SMALL BUSINESS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
136              Small Business Lending Companies Regulations                                                             3245-AE14       Proposed Rule
                                                                                                                                                  Stage
137              Small Business Size Standards; Restructuring of Size Standards                                           3245-AF11       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             SOCIAL SECURITY ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
138              Privacy and Disclosure of Official Records and Information (711P)                                        0960-AE88       Proposed Rule
                                                                                                                                                  Stage
139              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)                                                                          Stage
140              Representative Payment Under Titles II, VIII, and XVI of the Social Security Act (949F)                  0960-AF83       Proposed Rule
                                                                                                                                                  Stage
141              Elimination of Clothing From the Definitions of Income and In-Kind Support and Maintenance,              0960-AF84       Proposed Rule
                 Exclusions of One Automobile, and Household Goods and Personal Effects Under SSI From Resources                                  Stage
                 (950P)
142              Evidence Requirement for Assignment of Social Security Numbers (SSNs); Assignment of SSNs to             0960-AF87       Proposed Rule
                 Foreign Students (960P)                                                                                                          Stage

[[Page 72419]]

 
143              Amendments to the Ticket to Work and Self-Sufficiency Program (967P)                                     0960-AF89       Proposed Rule
                                                                                                                                                  Stage
144              Elimination of Parent-to-Child Deeming for Individuals Who No Longer Meet the Definition of Spouse       0960-AF96       Proposed Rule
                 of the Natural or Adoptive Parent (793P)                                                                                         Stage
145              Administrative Wage Garnishment (To Repay a Debt Owed to the Social Security Administration) (724F)      0960-AE92    Final Rule Stage
146              OASDI and SSI; Administrative Review Process; Video Teleconferencing Appearances Before                  0960-AE97    Final Rule Stage
                 Administrative Law Judges of the Social Security Administration (737F)
147              Revised Medical Criteria for Evaluating Impairments of the Digestive System (800F)                       0960-AF28    Final Rule Stage
148              Continuation of Benefit Payment to Certain Individuals Who Are Participating in a Program of             0960-AF86    Final Rule Stage
                 Vocational Rehabilitation Services, Employment Services, or Other Support Services (925F)
149              Administrative Review Process; Incorporation by Reference of Oral Findings of Fact and Rationale in      0960-AF92    Final Rule Stage
                 Wholly Favorable Written Decisions (964I)
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                            NATIONAL INDIAN GAMING COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                 Identification   Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
150              Technical Standards for Game Classifications, Gaming Machines, and Gaming Systems                        3141-AA29       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 72420]]

DEPARTMENT OF AGRICULTURE (USDA)
Statement of Regulatory Priorities
 In 2004, USDA plans to issue a variety of regulations that address a 
wide range of agricultural issues. Our principle focus will be the 
continued implementation of the Farm Security and Rural Investment Act 
of 2002 (Farm Bill) as farmers, ranchers, and other USDA customers 
participate in new and existing Federal farm programs. While the Farm 
Bill and other future legislative initiatives are implemented, the 
Department is working to reduce the regulatory burden on program 
participants by focusing as much as possible on outcome-based 
regulation through implementing more efficient and simplified 
information collections and continuing to migrate to efficient 
electronic services and capabilities. Important areas of activity 
include the following:
[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.
[sbull] The Department will continue to develop regulations that 
            support alternative markets for agricultural products and 
            activities, such as biobased products and bioenergy 
            processes.
Reducing Paperwork Burden on Customers
 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. To meet the requirements of the 
Government Paperwork Elimination Act (GPEA), agencies across the 
Department are providing electronic alternatives to their traditionally 
paper-based customer transactions. The Farm Service Agency, Natural 
Resources Conservation Service, Rural Development, and Risk Management 
Agency continue supporting the objectives of the Freedom to E-File Act 
through their efforts to comply with GPEA. [Freedom to E-File directed 
the agencies, to the maximum extent practicable, to modify forms into 
user-friendly formats with user instructions and to permit those forms 
to be downloaded and submitted via facsimile, mail, or similar means.] 
As a result, producers should have the option to electronically file 
forms and all other documentation. Complimentary to the activities to 
comply with GPEA, the Department is implementing an electronic 
authentication capability that allows customers to ``sign-on'' once and 
conduct business with all USDA agencies. Underlying these efforts will 
be analyses to identify and eliminate redundant data collections and 
streamline collection instructions. The end result of implementing 
these initiatives 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. The 2002 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
 Nine agencies are represented in this regulatory plan. They include 
the Farm Service Agency, the Food and Nutrition Service, the Food 
Safety and Inspection Service, the Animal and Plant Health Inspection 
Service, the Agricultural Marketing Service, the Forest Service, the 
Natural Resources Conservation Service, the Rural Housing Service, and 
the Rural Business-Cooperative Service. This document represents 
summary information on prospective significant regulations as called 
for in Executive Order 12866. A brief comment on each of the eight 
agencies appears below, which summarizes the Agency mission and its key 
regulatory priorities. The Agency summaries are followed by the 
regulatory plan entries.
Farm Service Agency
Mission: The Farm Service Agency's (FSA) mission is to stabilize farm

[[Page 72421]]

income, assist owners and operators of farms and ranches to conserve 
and enhance soil, water, and related natural resources, provide credit 
to new or disadvantaged farmers and ranchers, and help farm operations 
recover from the effects of disaster, as prescribed by various 
statutes.
Priorities: FSA's priority for 2004 will be to continue implementing 
the 2002 Farm Bill, the Farm Security and Rural Investment Act of 2002. 
The 2002 Farm Bill governs Federal farm programs for 2003 through 2007. 
Among its major provisions, it provides 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 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 new programs required 
complete revision of the existing program regulations. 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, 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 associations.
 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 the majority of the forms used by farm program and farm 
loan program customer groups. Most 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 in 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' 
2004 regulatory plan supports the broad goals and objectives in the 
Agency's strategic plan that include:
Improved nutrition of children and low-income people. This goal 
represents FNS' efforts to improve nutrition by providing access to 
program benefits (Food Stamps, WIC food packages, commodities, and 
State administrative funds), nutrition education, and quality meals and 
other benefits. It includes three major objectives: 1) improved food 
security, which reflects nutrition assistance benefits issued to 
program participants; 2) healthy food choices among FNS program 
participants, which represents our efforts to improve nutrition 
knowledge and behavior through nutrition education and breastfeeding 
promotion, and to support healthy eating and physical activity to 
address the epidemic of overweight and obesity; and 3) improved 
nutritional quality of meals, food packages, commodities, and other 
program benefits, which represents our efforts to ensure that program 
benefits meet the appropriate nutrition standards to effectively 
improve nutrition for program participants.
In support of this goal, FNS plans to publish proposed rules and 
develop final 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 to 
streamline complex rules, simplify program administration, support 
work, and improve access to benefits. This includes provisions to 
restore food stamp eligibility to legal immigrants who have lived in 
this country for at least 5 years, as well as immigrant children and 
disabled, without a waiting period, and other changes that will reduce 
reporting burden on working families. The Agency also plans to issue an 
advance notice of proposed rulemaking addressing possible changes to 
the food packages provided in WIC.
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

[[Page 72422]]

fraud, which represents the Agency's effort to reduce participant and 
Agency errors, and to control Food Stamp trafficking and Food Stamp and 
WIC participant, vendor, and administrative fraud; and 2) improved 
efficiency of program administration, which represents our efforts to 
streamline program operations and improve program structures as 
necessary to maximize their effectiveness.
In support of this goal, FNS plans to publish proposed rules and 
develop final rules implementing provisions of Public Law 107-171 that 
give States substantial new flexibility to streamline 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 pair of rules implementing this law will offer most States 
relief from costly sanctions 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 an implementing 
rule, making changes in Child and Adult Care Food Program (CACFP) rules 
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 
wholesome, not adulterated, and properly marked, labeled, and packaged.
Priorities: FSIS is committed to developing and issuing science-based 
regulations intended to ensure that meat, poultry, and egg products are 
wholesome and not adulterated or misbranded. FSIS continues to review 
its existing authorities and regulations to ensure that emerging food 
safety challenges are adequately addressed, to streamline excessively 
prescriptive regulations, and to revise or remove regulations that are 
inconsistent with the Agency's hazard analysis and critical control 
point regulations.
 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:
 In February 2001, FSIS proposed a rule to establish food safety 
performance standards for all processed ready-to-eat (RTE) meat and 
poultry products and for partially heat-treated meat and poultry 
products that are not ready-to-eat. The proposal contained provisions 
addressing post-lethality contamination of RTE products with Listeria 
monocytogenes. In June 2003, FSIS published an interim final rule 
requiring establishments that produce RTE products to apply verified 
control measures to prevent such product contamination. The Agency is 
planning further action with respect to other elements of the 2001 
proposal.
 FSIS intends to propose regulations to prohibit for use as human food 
certain materials from cattle. Scientific studies have demonstrated 
that such materials from cattle presenting clinical signs of bovine 
spongiform encephalopathy (BSE) contain the agent that causes the 
disease. To date, no cases of BSE have been found in the United States 
cattle herd. However, the USDA response to BSE has been proactive and 
preventive. In this proposed rule, FSIS seeks to mitigate a foreseeable 
risk.
 FSIS has proposed a rule clarifying requirements for meat produced 
using advanced recovery systems by replacing the compliance program 
parameters in the current regulations with non-compliance criteria for 
bone solids, bone marrow, and neural tissue. Establishments would have 
to have process control procedures in place before labeling or using 
the product derived by use of such systems.
 FSIS will propose removing from the poultry products inspection 
regulations the requirement for ready-to-cook poultry products to be 
chilled to 40 [deg]F or below within certain time periods according to 
the weight of the dressed carcasses.
 In addition, FSIS is planning to propose requirements for 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 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 labeling for egg 
products.
 FSIS will also propose to remove provisions that prescribe the 
substances and amounts of such substances that must be used to produce 
pumped bacon. FSIS will propose to replace these prescriptive 
provisions with an upper limit for nitrite and a performance standard 
that establishments producing pumped bacon would be required to meet.
 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.
 Post-September 11, 2001, initiatives: FSIS has not proposed new 
regulations in response to the September 11, 2001, events. In 2001, 
however, FSIS issued non-regulatory security guidelines for food plants 
within the Agency's jurisdiction, and in August this year, the Agency 
issued similar guidelines for the transportation and distribution of 
meat, poultry, and egg products.
 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. The 
Agency's post-September 11, 2001, security guidance materials were 
prepared especially for the benefit of small firms involved in the 
production, transportation, and distribution of meat, poultry, and egg 
products.
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 strengthen the protection provided to 
plant resources. Planned initiatives include revisions to the 
regulations for the introduction of organisms and products altered or 
produced through genetic engineering to

[[Page 72423]]

reflect new consolidated authorities under the Plant Protection Act and 
revisions to the regulations for the importation of nursery stock 
(plants, roots, seeds, bulbs, and other propagative materials) to 
reduce the pest risk posed by imported propagative material.
 The Agency is proceeding with plans to amend the regulations for the 
importation of unmanufactured wood by adopting an international 
standard for treatment of solid wood packing material.
 In recognizing the need to minimize impediments to trade while 
providing necessary protection to plant resources, APHIS is developing 
a proposal to streamline the process for approving new fruits and 
vegetables for importation.
 APHIS has regulatory initiatives to ensure that a comprehensive 
framework is in place to address the threats posed to animal resources. 
These include initiatives to ensure the adequate 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, as well as 
several initiatives related to the group of neurological diseases known 
as transmissible spongiform encephalopathies, including scrapie (a 
disease of sheep and goats), bovine spongiform encephalopathy (BSE, 
which affects cattle), and chronic wasting disease (a disease of deer 
and elk). BSE-related projects include rulemaking to address the 
relatively low risks posed by certain imports from countries such as 
Canada, where BSE has been detected but where effective measures have 
been in place to prevent its spread through the animal and human food 
chain. Also, following receipt of comments on an advance notice of 
proposed rulemaking published earlier this year, APHIS, in coordination 
with the Department's Food Safety and Inspection Service, is 
considering various options for addressing the disease risks that may 
be presented by the disposal of nonambulatory animals and dead stock 
should BSE be introduced into the United States.
 APHIS is also continuing to work with the Centers for Disease Control 
and Prevention to implement and amend, as necessary, 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.
 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: (1) On October 27, 2003, AMS published a proposed rule in 
the Federal Register to amend the Livestock Mandatory Reporting 
regulations to modify the requirements for the submission of 
information on domestic and imported boxed lamb cuts sales. This action 
would amend the definition of ``carlot-based'' by adding language to 
limit carlot-based sales of boxed lamb cuts to transactions between a 
buyer and a seller consisting of 1,000 pounds or more of one or more 
individually boxed lamb items and amend the definition of ``importer'' 
by reducing the volume level of annual lamb imports establishing a 
person as an importer from 5,000 metric tons of lamb meat products per 
year to 2,500 metric tons. These amendments would improve AMS' ability 
to publish meaningful market information on sales of imported and 
domestic lamb cuts.
 (2) As mandated by the 2002 Farm Bill, AMS is establishing a mandatory 
country of origin program for beef, lamb, pork, fish, perishable 
agricultural commodities, and peanuts. Under current Federal laws and 
regulations, country of origin labeling is not universally required for 
these commodities. In particular, labeling of U.S. origin is not 
mandatory, and labeling of imported products at the consumer level is 
required only in certain circumstances. Thus, consumers desiring to 
purchase products based on country of origin are not fully able to do 
so. A proposed rule was developed based on interim voluntary guidelines 
also required by the 2002 Farm Bill that were issued on October 8, 
2002, and related input from listening sessions held throughout the 
country during 2003. The proposed rule was published in the Federal 
Register on October 30, 2003.
 (3) On April 12, 2003, Congress amended the Organic Foods Production 
Act (OFPA) to authorize certification of wild seafood. In response to 
this, AMS plans to amend the National Organic Program (NOP) regulations 
to add practice standards for organic certification of wild-caught and 
aquatic farm raised species. Under the OFPA, an organic certification 
program must be established for producers and handlers of agricultural 
products that have been produced using organic methods. The NOP has 
been reviewing organic certification of fish including wild-caught and 
aquaculture operations in response to a FY 2000 congressional mandate 
to develop regulations for the certification of seafood. The NOP has 
engaged in public meetings and workshops and conducted public comment 
proceedings on this subject.
 (4) Under the 2002 Farm Bill, the Federal Agriculture Improvement and 
Reform Act (1996 Farm Bill) was amended to exempt any person that 
produces and markets solely 100 percent organic products from paying 
assessments under a commodity promotion law. The 1996 Farm Bill governs 
all research and promotion programs and certain marketing order 
programs. AMS plans to issue two proposed rules to implement this 
requirement. Currently, there are 16 existing national research and 
promotion programs and 28 marketing order programs that contain market 
promotion provisions.
 AMS Program Rulemaking Pages: All 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.
Forest Service
Mission: The mission of the Forest Service is to sustain the health, 
productivity, and diversity of the Nation's forests and rangelands to 
meet the needs of present and future generations. This includes 
protecting and managing National Forest System lands; providing 
technical and financial assistance to States, communities, and private 
forest landowners; and developing and providing scientific and 
technical assistance.
Priorities:The Forest Service's priority for fall 2003 is to publish 
final regulations at 36 CFR part 219, subpart A, to establish a 
framework for National

[[Page 72424]]

Forest System land management planning. The final rule reaffirms an 
emphasis on sustainability to provide for multiple uses over time and 
reaffirms an adaptive cycle of land management planning, including 
detailed project planning, plan implementation, monitoring, evaluation, 
and plan amendment or revision. The final rule is based on the 
principle that plans provide a framework for subsequent detailed 
project analysis and that analysis and disclosure are continuous 
throughout the adaptive planning cycle. A proposed rule was published 
in the Federal Register on December 6, 2002 (67 FR 72770).
Natural Resources Conservation Service
 Mission: As a part of USDA Natural Resources Conservation Service 
(NRCS) works to improve natural resources conditions on working lands. 
NRCS helps farmers, ranchers, and operators by providing technical and 
financial assistance for adopting conservation practices on their 
lands.
Priorities: A key priority for NRCS is to implement the Conservation 
Security Program (CSP), authorized by the Farm Security and Rural 
Investment Act of 2002 (Pub. L. 107-171, May 13, 2002) (the Act) 
amended the Food Security Act of 1985 (16 U.S.C. 3801 et seq.). The CSP 
is a voluntary program that provides financial and technical assistance 
to producers who advance the conservation and improvement of soil, 
water, air, energy, plant and animal life, and other conservation 
purposes on Tribal and private working lands. Such lands include 
cropland, grassland, prairie land, improved pasture, and range land, as 
well as forested land and other non-cropped areas that are an 
incidental part of the agriculture operation.
Rural Housing Service
Mission: As a 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.
 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.
 The new regulation was published in the Federal Register as a proposed 
rule on June 2, 2003. We received 2,965 comments from 136 respondents. 
The Agency is now reviewing those comments and preparing the Final Rule 
Document for an estimated publication date of June 30, 2004.
Rural Business-Cooperative Service
Mission: The mission of the Rural Business-Cooperative Service is to 
enhance the quality of life for rural Americans by providing leadership 
in building competitive businesses including sustainable cooperatives 
that can prosper in the global marketplace.
 We meet these goals by:
Investing financial resources and providing technical assistance to 
businesses and cooperatives located in rural communities; and
Establishing strategic alliances and partnerships that leverage public, 
private, and cooperative resources to create jobs and stimulate rural 
economic activity.
Priorities: The key regulatory priority for the fall 2003 regulatory 
plan is the RBS Renewable Energy Systems and Energy Efficiency 
Improvements Proposed Rule.
 Renewable Energy Systems and Energy Efficiency Improvements.
 This proposed rule resulted from section 9006 of the Farm Security and 
Rural Investment Act of 2002 (Act), which requires that the Secretary 
establish a program to ``make loans, loan guarantees, and grants to 
farmers, ranchers, and rural small businesses to purchase renewable 
energy systems and make energy efficiency improvements.'' The Act 
directs that, in funding such projects, USDA direct and guaranteed 
loans and grant financing is not to exceed 50 percent of the cost of 
the activity and grant-only funding is not to exceed 25 percent of the 
cost of the activity.
 Since this is a new program, guidelines need to be established 
concerning the nature of the program and the delivery model to be used, 
so that a full set of implementation policies can be developed. The 
Office of General Counsel has mandated that regulations must be in 
place to operate the program. The proposed rule will establish 
regulations to implement the direct and guaranteed loan and grant 
program. These regulations will allow for the integration of all 
program authorities and permit full attention to all of the potential 
contingencies and issues.
_______________________________________________________________________
USDA--Agricultural Marketing Service (AMS)

                              -----------

                             PRERULE STAGE

                              -----------

1. NATIONAL ORGANIC PROGRAM: ADD STANDARDS FOR THE ORGANIC 
CERTIFICATION OF WILD CAPTURED AQUATIC ANIMALS (TM-01-08)
Priority:


Other Significant

[[Page 72425]]

Legal Authority:


7 USC 6501 through 6522


CFR Citation:


7 CFR 205


Legal Deadline:


None


Abstract:


AMS is revising regulations pertaining to labeling of agricultural 
products as organically produced and handled (7 CFR part 205). The term 
``aquatic animal'' will be incorporated in the definition of livestock 
and to establish production and handling standards for operations that 
capture aquatic animals from the wild. AMS has defined ``aquatic 
animal'' as any finfish or shellfish used for human consumption, 
whether taken from regulated but free roaming marine and fresh water 
populations (wild captured) or propagated and raised in a controlled or 
selected environment (aquaculture). Production standards for operations 
producing aquatic animals will incorporate requirements for livestock 
origin, feed ration, health care, living conditions, and recordkeeping. 
Handling standards for such operations will address prevention of 
commingling of organically produced commodities and prevention of 
contact between organically produced and prohibited substances.


Statement of Need:


This amendment to the National Organic Program is intended to 
facilitate interstate commerce and marketing of fresh and processed 
aquatic animals that are organically produced and to assure consumers 
that such products meet consistent, uniform standards. This amendment 
will establish national standards for the production and handling of 
organically produced aquatic animals and products, including a national 
list of substances approved and prohibited for use in organic 
production and handling.


Summary of Legal Basis:


This amendment is proposed under the Organic Foods Production Act of 
1990 (OFPA). OFPA includes fish for food in its definition of 
livestock. Additionally, on April 12, 2003, Congress amended OFPA 
section 2107 (7 U.S.C. 6506) to authorize certification of wild 
seafood.


Alternatives:


AMS is fulfilling a congressional mandate to proceed with rulemaking 
for the establishment of national standards for the organic production 
and handling of aquatic animals.


Other options are to do nothing or to proposed regulations prohibiting 
the labeling of aquatic animals as organically produced. Neither 
alternative is viable inasmuch as Congress has amended OFPA to 
authorize certification of wild seafood and is expecting the USDA to 
engage in rulemaking to establish standards for the production, 
handling, and labeling of organic aquatic animals.


Anticipated Cost and Benefits:


Potential benefits to consumers include more information on organic 
aquatic animals and protection from false and misleading organic 
claims. This proposal will address the problem of existing certifying 
agents using different standards. This proposal will also resolve the 
issue of whether aquatic animals can be labeled as organically 
produced.


The costs of this proposed regulation are the direct costs to comply 
with the specific standards. USDA--accredited certifying agents 
potentially will incur additional costs of accreditation should they 
opt to certify producers and handlers of aquatic animals. New 
applicants for accreditation to certify producers and handlers of 
aquatic animals under the National Organic Program will incur fees for 
accreditation. Producers and handlers of organically produced and 
handled aquatic animals will incur costs for certification levied by 
USDA--accredited certifying agents. USDA would not levy any fees on the 
certified operations. Producers and handlers will face numerous 
provisions that will regulate their production and handling methods. 
Retailers would not be directly regulated but would be subject to the 
same requirements for organic animals and products as they are 
currently for other foods under the NOP. AMS believes this action will 
have a minimal impact on retailers. Certified handlers will have to 
comply with requirements regarding the approved use of labels. The 
USDA, states operating State programs, and certifying agents will incur 
costs for enforcement of these new organic standards. Certifying 
agents, producers, and handlers would incur costs for reporting and 
recordkeeping. Certifying agents will be required to file reports and 
documents with the USDA and to maintain records regarding their 
accreditation and the certification of their clients. Certified 
operations will be required to develop and annually update an organic 
system plan and to maintain records regarding their certification and 
the administration of their operation.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          04/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, Local, State, Tribal


Agency Contact:
Richard H. Mathews
Program Manager
Department of Agriculture
Agricultural Marketing Service
Rm. 2510--South
14th & Independence Avenue SW
Washington, DC 20250
Phone: 202 720-3252
Fax: 202 205-7808
Email: [email protected]
RIN: 0581-AB97
_______________________________________________________________________
USDA--AMS

                              -----------

                          PROPOSED RULE STAGE

                              -----------

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


Other Significant


Legal Authority:


7 USC 4501 et seq


CFR Citation:


7 CFR 1150


Legal Deadline:


Final, Statutory, August 2002, Final.


Abstract:


The 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.

[[Page 72426]]

Statement of Need:


The National Dairy Promotion and Research Program must be amended to 
conform with the Farm Security and Rural Investment Act of 2002 (2002 
Farm Bill), which amended the Dairy Promotion and Research Program. 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 program 
assessments collected. It is estimated that the fees will be 
approximately $60,000 monthly after start-up. The annual assessment 
collected will be approximately $9.5 million.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/03
Final Action                                                   04/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


None


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

                              -----------

                            FINAL RULE STAGE

                              -----------

3. 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 to 
1636(h)) as an amendment to the Agricultural Marketing Act of 1946, as 
amended (7 U.S.C. 1621 et seq.). The Act gives USDA the latitude to 
require mandatory reporting 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            68 FR 61141                                    10/27/03
Final Action                                                   03/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


State


Federalism:


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


Agency Contact:
John E. Van Dyke
Branch Chief
Department of Agriculture
Agricultural Marketing Service
Room 2619--South
L&S
14th & Independence Avenue SW
Washington, DC 20250
Phone: 202 720-6231
Fax: 202 690-3732
Email: [email protected]
RIN: 0581-AB98
_______________________________________________________________________
USDA--AMS
4. [bull] MANDATORY COUNTRY OF ORIGIN LABELING OF BEEF, PORK, LAMB, 
FISH, PERISHABLE AGRICULTURAL COMMODITIES, AND PEANUTS (LS-03-04)
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


7 USC 1621 through 1627, Agricultural Marketing Act of 1946


CFR Citation:


7 CFR 60

[[Page 72427]]

Legal Deadline:


Final, Statutory, September 30, 2004, Final.


Abstract:


The Agricultural Marketing Services (AMS) issued a proposed rule on 
October 30, 2003, to implement a mandatory country of origin labeling 
program for covered commodities as mandated by the Farm Security and 
Rural Investment Act of 2002 (Pub. L. 107-171). The Farm Security and 
Rural Investment Act amended the Agricultural Marketing Act of 1946 to 
require retailers to notify their customers of the country of origin 
labeling program not later than September 30, 2004. Covered commodities 
include muscle cuts of beef (including veal), lamb, and pork; ground 
beef, ground pork; farm-raised fish and shellfish; wild fish and 
shellfish; perishable agricultural commodities (fresh and frozen fruits 
and vegetables); and peanuts.


Statement of Need:


Under current Federal laws and regulations, country of origin labeling 
is not universally required for the covered commodities. In particular, 
labeling of U.S. origin is not mandatory, and labeling of imported 
products at the consumer level is required only in certain 
circumstances. Thus, consumers generally do not have the ability to 
purchase products based on country of origin. This intent of the law is 
to provide consumers with additional information on which to base their 
purchasing decisions.


Summary of Legal Basis:


Section 10816 of Public Law 107-171 amended the Agricultural Marketing 
Act of 1946 to require retailers to inform consumers of the country of 
origin for covered commodities beginning September 30, 2004, and 
requires USDA to promulgate requirements for the mandatory labeling 
program no later than September 30, 2004.


Alternatives:


Various methods are being considered by which the objectives of this 
law could be accomplished. The proposed rule specifically invites 
comment on several alternatives including alternative definitions for 
``processed food item,'' alternative labeling of mixed origin, and 
alternatives to using ``slaughtered'' on the label. The proposed rule 
provides for a 60-day comment period which closes on December 29, 2003. 
In formulating the final mandatory regulations, the Agency will analyze 
all of the public comments that were received and will give due 
consideration to any alternatives brought forth by the commenters.


Anticipated Cost and Benefits:


USDA has examined the economic impact of the proposed rule as required 
by Executive Order 12866. The estimated benefits associated with this 
rule are likely to be negligible. The estimated first-year incremental 
cost for growers, producers, processors, wholesalers, and retailers 
ranges from $582 million to $3.9 billion. The estimated cost to the 
U.S. economy in higher food prices and reduced food production in the 
tenth year after implementation of the rule ranges from $138 million to 
$596 million. AMS has invited further comment on start up costs and 
maintenance costs for the first year and beyond for firms directly 
affected by the proposed rule.


Risks:


AMS has not identified any risks at this time.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 61944                                    10/30/03
Final Action                                                   04/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


State


Federalism:


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


Agency Contact:
William Sessions
Associate Deputy Administrator
Department of Agriculture
Agricultural Marketing Service
Room 2092--South, Stop 0249
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5705
Email: [email protected]
RIN: 0581-AC26
_______________________________________________________________________
USDA--Animal and Plant Health Inspection Service (APHIS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

5. 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:


This rulemaking would establish requirements for the interstate 
movement of farmed elk and deer and 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 rulemaking to establish a voluntary certification 
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.

[[Page 72428]]

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                                                           12/00/03
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
6. [bull] BOVINE SPONGIFORM ENCEPHALOPATHY: MINIMAL RISK REGIONS AND 
IMPORTATION OF COMMODITIES
Priority:


Other Significant


Legal Authority:


7 USC 450; 7 USC 1622; 7 USC 7701 to 7772; 7 USC 8301 to 8317; 21 USC 
136 to 136a; 31 USC 9701; 42 USC 4331 to 4332


CFR Citation:


9 CFR 93 to 95


Legal Deadline:


None


Abstract:


This rulemaking would amend the regulations regarding the importation 
of animals and animal products to recognize a category of regions that 
present a minimal risk of introducing bovine encephalopathy (BSE) into 
the United States via live ruminants and ruminant products and would 
add Canada to this category.


Statement of Need:


BSE is a progressive neurological disorder of cattle that results from 
infection by an unconventional transmissible agent and is not known to 
exist in the United States. It appears that BSE is spread primarily 
through the use of ruminant feed containing protein and other products 
from ruminants infected with BSE. The regulations in 9 CFR parts 93, 
94, 95, and 96 have prohibited the importation of live ruminants and 
certain ruminant products and byproducts from two categories of 
regions: Those regions in which BSE is known to exist, and those 
regions that present an undue risk of introducing BSE into the United 
States because their import requirements are less restrictive than 
those that would be acceptable for import into the United States and/or 
because the regions have inadequate surveillance. Based on a review of 
the risk presented by regions in which a BSE-affected animal has been 
diagnosed, but in which precautionary measures have been taken that 
reduce the risk of BSE being introduced into the United States by 
imports from such regions, we are developing a rule that would 
recognize an additional category of regions--the BSE minimal--risk 
region. The rule would allow the importation of certain live ruminants 
and ruminant products and byproducts from minimal risk regions under 
certain conditions and would designate Canada as a minimal-risk region. 
This action is based on our assessment that the rule would continue to 
protect against the introduction of BSE into the United States while 
removing unnecessary prohibitions on certain commodities from Canada 
and other regions that qualify as BSE minimal-risk regions.


Summary of Legal Basis:


The Animal Health Protection Act (7 U.S.C. 8301 to 8317) provides that 
regulation of animals and other articles

[[Page 72429]]

by the Secretary of Agriculture is necessary to prevent and eliminate 
burdens on interstate and foreign commerce; to effectively regulate 
interstate commerce and foreign commerce; and to protect the 
agriculture, environment, economy, and health and welfare of the people 
of the United States.


Alternatives:


Alternatives to this rulemaking would be to continue to prohibit 
certain ruminants and ruminant products from entering from Canada or to 
allow these commodities to enter under less restrictive conditions than 
are being considered. To continue to prohibit these imports from 
Canada, when feasible precautionary measures are available, would be 
contrary to trade policies called for in the World Trade Organization's 
``Agreement on Sanitary and Phytosanitary Measures.'' On the other 
hand, importations without appropriate mitigation measures would 
subject the United States to an unacceptable risk of BSE introduction. 
APHIS is committed to ensuring that the ruminant populations of the 
United States are fully protected from the introduction of BSE and 
believes that this rule is a balanced, science-based response to the 
detection of BSE in Canada, given Canada's actions since detection of 
the disease and the rule's inclusion of appropriate risk mitigation 
requirements.


Anticipated Cost and Benefits:


On August 8, 2003, the Secretary announced that certain ruminant-
derived products would be allowed to enter the United States from 
Canada under permit. Several of the items included in the announcement 
are also covered by this rulemaking. The most important one is boneless 
beef from cattle less than 30 months of age. APHIS has analyzed the 
potential effects of the importation of commodities covered by the 
rule, including ones, such as boneless beef, that could be imported 
under permit on or after August 8, 2003, by comparing U.S. markets with 
and without these imports from Canada. Slaughter cattle, feeder cattle, 
and beef would be the main commodities affected by reinstatement of the 
importation of ruminant and ruminant products from Canada. In the near 
term, the additional supplies would cause prices to fall. Percentage 
price declines indicated by the results of the analyses for slaughter, 
cattle, feeder cattle, and beef suggest that near-term effects on 
affected entities would not be significant. The price declines would be 
accompanied by an increase in the number of cattle slaughtered and a 
decrease in the number of slaughtered cattle supplied by U.S. entities. 
These changes translate into a positive net benefit in the near term. 
It is emphasized that the estimated effects would be near term, 
occurring during the first year or so following the reestablishment of 
imports. In the longer term, production and marketing adjustments by 
U.S. and Canadian firms, and those in other countries in response to 
changed market conditions, would create new price-quantity 
equilibriums. Also, if other countries do not accept the age 
restrictions and other precautionary measures as adequate safeguards, 
U.S. exports of those commodities could be affected.


Risks:


On May 20, 2003, the Canadian Food Inspection Agency reported a case of 
BSE in a beef cow in northern Alberta. To prevent the introduction of 
BSE into the United States, APHIS published an interim rule on May 29, 
2003 (68 FR 31939-31940, Docket No. 03-058-1), effective retroactively 
to May 20, 2003, to add Canada to the list of regions where BSE exists. 
As a result of that action, the importation of ruminants that have been 
in Canada and the importation of meat, meat products, and certain other 
products and byproducts of ruminants that have been in Canada are 
prohibited or restricted. This rulemaking would relieve restrictions on 
the importation of ruminants and ruminant products and byproducts from 
Canada by establishing Canada as a BSE minimal-risk region based on an 
analysis of the conditions considered for such a designation and the 
information available regarding how Canada meets those conditions. The 
risk document, ``Risk Analysis: BSE Risk From Importation of Designated 
Ruminants and Ruminant Products From Canada Into the United States, 
September 5, 2003,`` also identifies the measures that APHIS believes 
are necessary to mitigate any BSE risk that specific commodities 
imported from Canada might present to the United States.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 62386                                    11/04/03
NPRM Comment Period End                                        01/05/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal


Agency Contact:
Dr. Karen A. James-Preston
Director, Technical Trade Services Team, NCIE, VS
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road
Unit 38
Riverdale, MD 20737
Phone: 301 734-4356
RIN: 0579-AB73
_______________________________________________________________________
USDA--APHIS

                              -----------

                            FINAL RULE STAGE

                              -----------

7. 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:


This rule would amend the 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 reviewed these regulations to determine their sufficiency, 
should an occurrence of foot-and-mouth disease occur in the United 
States. This review was prompted, in part, by a series of outbreaks of 
foot-and-mouth disease that occurred 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,

[[Page 72430]]

as well as the payment of an indemnity to those persons who suffer loss 
of property as a result of foot-and-mouth disease.


Summary of Legal Basis:


The Secretary of Agriculture, either independently or in cooperation 
with 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 Action                                                   06/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, State


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
8. AGRICULTURAL BIOTERRORISM PROTECTION ACT OF 2002; POSSESSION, USE, 
AND TRANSFER OF 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, a 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, as well as 
regulations concerning the possession, use, and transfer of listed 
biological agents and toxins.


Statement of Need:


Section 212 of the Public Health Security and Bioterrorism Response Act 
of 2002 (Pub. L. 107-188) requires the Secretary of Agriculture to 
establish regulations for the possession, use, and transfer of 
biological agents and toxins that she determines have the potential to 
pose a severe threat to animal or plant health or to animal or plant 
products. Among other things, the Act requires the regulations to 
require registration with the Secretary and include appropriate 
safeguard and security measures, including database checks by the 
Attorney General of individuals and facilities seeking to register with 
the Secretary.


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 to 
204) and the Department of Agriculture (subtitle B, sections 211 to 
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 
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.

[[Page 72431]]

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.


Anticipated Cost and Benefits:


While the costs associated with this rule could be considerable, some 
of those impacts are somewhat offset by previous requirements, funding 
from other sources for upgrades that would otherwise be mandated by 
this rule, and flexibility in the rules that allow for site-specific 
needs to be met in the most cost-effective manner possible. In 
addition, these costs are greatly outweighed by the benefits of 
preventing a deliberate introduction of a listed agent or toxin into 
the United States. Should any listed agent or toxin be intentionally 
introduced, the consequences would be significant as is demonstrated by 
natural outbreaks that have occurred. Consequences could include costs 
of eradiation efforts, disruption of markets, difficulties in 
sustaining an adequate food and fiber supply, and the potential spread 
of disease infestations over large areas. Deliberate introduction 
greatly increases the probability of an agent or toxin becoming 
established and causing wide-ranging and devastating impacts on the 
economy, disruption to society, diminished confidence in public and 
private institutions, and possible loss of life.


Risks:


The regulations include 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 F67 FR 76908                                    12/13/02
Second Interim Final Rule Comment Period End                   02/11/03
Second Interim Final Rule Effective                            02/11/03
Third Interim Fi68 FR 62218rovisional Registration             11/03/03
Third Interim Final Rule Effective                             11/03/03
Third Interim Final Rule Comment Period End                    01/02/04
Fourth Interim Final Rule; Amending Overlap Toxin Exclusion    12/00/03
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, State


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:
Michael J. Firko
Assistant Director, Plant Health Programs, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 137
Riverdale, MD 20737
Phone: 301 734-8758

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)

                              -----------

                            FINAL RULE STAGE

                              -----------

9. MULTI-FAMILY HOUSING (MFH) REINVENTION
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,

[[Page 72432]]

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 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. Funding for rehabilitation, 
preservation, and future new construction is being addressed through 
the budget process. To not publish the rule would substantially 
restrict RHS' ability to effectively administer the programs and cost 
the Agency significant credibility with the public and oversight 
organizations.


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.


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.


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.


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.


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

[[Page 72433]]

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            68 FR 32872                                    06/02/03
NPRM Comment Period End                                        08/01/03
Final Action                                                   06/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Sue Harris-Green
Deputy Director, Multi-Family Housing Direct Loans
Department of Agriculture
Rural Housing Service
6th Floor
Stop 0782
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-1660
Email: [email protected]
RIN: 0575-AC13
_______________________________________________________________________
USDA--Food and Nutrition Service (FNS)

                              -----------

                             PRERULE STAGE

                              -----------

10. [bull] SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, 
AND CHILDREN (WIC): REVISIONS TO WIC FOOD PACKAGES
Priority:


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


Legal Authority:


42 USC 1786


CFR Citation:


7 CFR 246


Legal Deadline:


None


Abstract:


Through this Advance Notice of Proposed Rulemaking (ANPRM), the 
Department is seeking public comment on the nutritional needs of the 
diverse WIC population and how health and development outcomes could 
best be improved via revision of regulations governing the WIC food 
packages. The Department will use comments received through this ANPRM 
and science from the Institute of Medicine, Food and Nutrition Board to 
develop a Notice of Proposed Rulemaking. (03-002)


Statement of Need:


The WIC Program provides supplemental foods designed to provide 
specific nutrients shown by research to be lacking in the WIC 
population's diet. WIC food packages and nutrition education are the 
chief means by which WIC affects the dietary quality and habits of 
participants. WIC food packages were designed to supplement 
participants' diets with nutritionally dense foods that prevent iron-
deficiency anemia; complement the eating patterns of pre-school 
children; and address the special nutrition requirements of pregnant 
and breastfeeding women. The WIC food packages were last revised in 
1980. 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. In light of emerging 
nutrition-related health issues and the new research-based Dietary 
Reference Intakes through this Notice, the Department is soliciting 
public comments to determine if the food packages can and should be 
revised to meet the nutritional needs of participants more effectively. 
And if so, what specific changes should be made to the food packages 
and why. Public comment will inform decisions and bolster the 
scientific and programmatic integrity of any rule that is proposed as a 
result of this process.


Summary of Legal Basis:


Public Law 95-627, enacted in November 1976, defined supplemental foods 
as those foods containing nutrients determined by nutritional research 
to be lacking in the diets of pregnant, breastfeeding, and postpartum 
women, infants, and children, as prescribed by the Secretary of 
Agriculture. The program direction stipulated by that law remains in 
effect today (42 U.S.C. 1786(b)(14)). The law also directs the 
Secretary in section 17(f)(11) of the Child Nutrition Act of 1966, as 
amended (42 U.S.C. 1786(f)(11)), to assure that, to the degree 
possible, the fat, sugar, and salt contents of WIC foods are 
appropriate. The law provides substantial latitude to the Department to 
prescribe by regulation the most appropriate supplemental foods. 
Historically, the Department has based its prescriptions of WIC foods 
on sound nutritional research and input from State and local agencies, 
the health and scientific communities, industry, and the general 
public. Current WIC food package regulations were published in 1980 (45 
FR 74854, November 12, 1980) that are consistent with the direction 
provided in Public Law 95-627.


In recent years, the Department has received numerous requests from WIC 
State agencies and participants to modify the current food packages to 
permit greater substitution of foods or introduction of new foods. 
Requests for revisions to the WIC food packages have also been received 
from Congress and other organizations with interests in the welfare of 
WIC participants.

[[Page 72434]]

Specifically, Congress requested through appropriations report language 
for fiscal years 2001-2002 (H.R. 106-619, S.R. 106-288, H.R. 107-116, 
and S.R. 107-41) that the Department develop a WIC food package rule 
that includes fruits and vegetables and that allows for cultural 
accommodations.


Alternatives:


The September 15, 2003, ANPRM includes 11 questions seeking 
alternatives, information, and supporting rationale. In the rulemaking 
process, the Department wishes to respond to the congressional request, 
as well as requests from other interested entities within the WIC 
community (including the National Advisory Council on Maternal, Infant, 
and Fetal Nutrition; the National WIC Association; and the American 
Dietetic Association) by soliciting recommendations from the public for 
scientifically based revisions to the WIC food packages that do not 
significantly increase the cost to the program or change the 
supplemental nature of the program. The Department is dedicated to 
addressing the many implications of a comprehensive revision of WIC 
food packages, specifically: Cultural and ethnic food preferences; 
commercial availability, variety, and appeal of foods; versatility in 
food preparation; feasibility of apportionment into daily servings for 
an individual over a month's time; State and local agency flexibility 
to design the food prescription; administrative feasibility and 
manageability by the State and local agencies and vendors; and burden 
and incentive for participants, potential participants, and their 
families.


The Department has enlisted the Food and Nutrition Board to provide 
independent technical experts to review comments submitted in response 
to this Notice, as well as available science, and to develop 
recommendations on revising the WIC food packages for the Department's 
consideration. The Department will then use the results of this 
independent review to shape a proposed rulemaking containing specific 
modifications to the WIC food packages.


Anticipated Cost and Benefits:


No cost/benefit information is necessary for this ANPRM. A detailed 
regulatory impact analysis outlining the specific costs and benefits of 
each proposed change to the WIC food packages will be developed and 
issued along with the proposed rulemaking, including response to the 
comments on the ANPRM.


Risks:


By issuing the ANPRM, the Department is minimizing the risk of 
inadvertently omitting or misrepresenting issues that may be critical 
to the best possible revision of the WIC food packages. The ANPRM 
offers the public an opportunity to participate in the Department's 
promulgation of a proposed rulemaking to revise the WIC food packages. 
The public will have a subsequent opportunity to submit comments on 
such revisions when the proposed rule is published.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           68 FR 53903                                    09/15/03
ANPRM Comment Period End                                       12/15/03
NPRM                                                           06/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


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


URL For More Information:
www.fns.usda.gov/wic/whatsnew.htm
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD39
_______________________________________________________________________
USDA--FNS

                              -----------

                          PROPOSED RULE STAGE

                              -----------

11. COMMODITY SUPPLEMENTAL FOOD PROGRAM (CSFP): PLAIN LANGUAGE, PROGRAM 
ACCOUNTABILITY, AND PROGRAM FLEXIBILITY
Priority:


Other Significant


Legal Authority:


PL 101-624; PL 104-127


CFR Citation:


7 CFR 247


Legal Deadline:


None


Abstract:


This rule will rewrite regulations pertaining to the Commodity 
Supplemental Food Program (7 CFR part 247) in ``plain language.'' It 
will also amend regulatory provisions in this part to increase program 
accountability and flexibility for program operators, and incorporate 
legislative provisions that have been implemented through program 
policy. (99-005)


Statement of Need:


This rule is necessary to amend regulatory provisions in 7 CFR part 247 
to increase program accountability and flexibility for program 
operators and incorporate legislative provisions that have been 
implemented through program policy.


Summary of Legal Basis:


Executive Order 12866 requires each agency to write regulations that 
are simple and easy to understand. The proposed rule meets these 
requirements. This proposed rule also incorporates legislative 
amendments found in sections 1771(d) and 1771(e) of the Food, 
Agriculture, Conservation, and Trade Act of 1990; section 402(b) of the 
Federal Agriculture Improvement and Reform Act of 1996; section 4201(b) 
of the Farm Security and Rural Investment Act of 2002; and the Single 
Audit Act Amendments of 1996.


Alternatives:


No alternatives available.


Anticipated Cost and Benefits:


Changes in the proposed rule reduce the burden imposed on State and 
local

[[Page 72435]]

agencies while ensuring program accountability, and are generally 
insignificant to the costs or overall operations of the program.


Risks:


There are no risks involved with this proposed rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 62164                                    10/31/03
NPRM Comment Period End                                        12/30/03
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State, Tribal


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC84
_______________________________________________________________________
USDA--FNS
12. 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                                                           01/00/04
NPRM Comment Period End                                        03/00/04
Final Action                                                   05/00/05
Final Action Effective                                         07/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 Undetermined


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD22
_______________________________________________________________________
USDA--FNS
13. FSP: HIGH PERFORMANCE BONUSES
Priority:


Other Significant


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 implement 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 publish the performance measures for the high

[[Page 72436]]

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                                                           12/00/03
NPRM Comment Period End                                        02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD29
_______________________________________________________________________
USDA--FNS
14. 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 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 August 22, 1996)--effective October 1, 2002, (2) are 
under 18 regardless of date of entry (current law limits eligibility to 
children who were in the country on August 22, 1996)--effective October 
1, 2003, and beyond, or (3) have lived in the U.S. for 5 years as a 
qualified alien beginning on date of entry--effective April 1, 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 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                                                           11/00/03
NPRM Comment Period End                                        12/00/03

[[Page 72437]]

Final Action                                                   12/00/04
Final Action Effective                                         02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 Undetermined


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD30
_______________________________________________________________________
USDA--FNS
15. 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                                                           11/00/03
NPRM Comment Period End                                        01/00/04
Final Action                                                   12/00/04
Final Action Effective                                         02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD32
_______________________________________________________________________
USDA--FNS
16. SENIOR FARMERS' MARKET NUTRITION PROGRAM (SFMNP)
Priority:


Other Significant


Legal Authority:


PL 107-171, sec 4306


CFR Citation:


7 CFR 249


Legal Deadline:


None


Abstract:


This proposed rule will implement the provision of the Farm Security 
and Rural Investment Act of 2002 (Pub. L. 107-171) that gives the 
Department the authority to promulgate regulations for the operation 
and administration of the SFMNP. The purposes of the SFMNP are to 
provide fresh, nutritious, unprepared locally grown fruits, vegetables, 
and herbs from farmers' markets, roadside stands, and community 
supported agriculture programs to low-income seniors and to increase 
the consumption of agricultural commodities by expanding, developing, 
and/or aiding in the development of domestic farmers' markets, roadside 
stands, and community supported agriculture programs. (02-012)


Statement of Need:


The SFMNP has been administered since fiscal year 2001 as a competitive 
grant program in which State agencies, interested in receiving a grant 
to operate the program, submitted an application for SFMNP grant funds 
to USDA's Food and Nutrition Service. Such grants were reviewed and 
ranked against a set of explicit criteria, and SFMNP grants were then 
awarded to those State agencies whose applications received the highest 
scores. Public Law 107-171 authorized funding for the SFMNP through FY 
2007 and also gave the Department the authority to promulgate 
regulations for the future operation and administration of the SFMNP. 
This legislative action establishes the SFMNP as a permanent nutrition 
assistance program and eliminates the need for State agencies to 
participate in an annual competition for program funds. Therefore, this 
proposed rulemaking converts the SFMNP from a competitive grant program 
to a permanent FNS-administered nutrition assistance program.


Summary of Legal Basis:


Public Law 107-171 (section 4306) authorized funding for the SFMNP 
through FY 2007 and also gave the Department the authority to 
promulgate regulations for the future operation and administration of 
the SFMNP.


Alternatives:


USDA considered a variety of alternatives when constructing the 
regulation for the SFMNP. Primarily, the proposed regulation is modeled 
after the WIC Farmers' Market Nutrition Program and the Senior Farmers' 
Market Nutrition Pilot Programs. Consistency lends to administrative 
ease among the State agencies, localities, and USDA, as well as 
provides continuity to beneficiaries and

[[Page 72438]]

farmers who have been operating the pilot programs since 2001. 
Nevertheless, USDA addressed seven specific alternatives: Type of grant 
structure, eligible grantees and recipients, the use of community-
supported agriculture programs, provision of administrative funding, 
eligibility requirements, verification procedures, and benefit levels. 
Each of these alternatives is explored in detail in the preamble to the 
proposed rulemaking.


Anticipated Cost and Benefits:


The funding level for the SFMNP is expected to remain stable through FY 
2007. Therefore, the Department does not anticipate significant changes 
to the costs/benefits of the SFMNP as a result of the publication of 
this proposed rule.


Risks:


The proposed rule carries a 90-day comment period, during which 
interested parties may submit comments on any and all provisions 
contained in the rulemaking. Once the comment period has expired, all 
comments received will be carefully considered in the development of 
the final rule. Opportunities for training on and discussion of the 
SFMNP regulations (in both their proposed and final forms) will be 
offered to State agencies and other entities with a vested interest in 
the operation and administration of the SFMNP.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/04
NPRM Comment Period End                                        05/00/04
Final Action                                                   09/00/04
Final Action Effective                                         10/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 Undetermined


URL For More Information:
www.fns.usda.gov
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD35
_______________________________________________________________________
USDA--FNS
17. FSP: DISCRETIONARY QUALITY CONTROL PROVISIONS OF TITLE IV OF PUBLIC 
LAW 107-171
Priority:


Other Significant


Legal Authority:


7 USC 2011 to 2032; PL 107-171


CFR Citation:


7 CFR 271; 7 CFR 273; 7 CFR 275; 7 CFR 277


Legal Deadline:


None


Abstract:


This proposed rule will implement several quality control changes to 
the Food Stamp Act required by sections 4118 and 4119 of title IV of 
the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171). 
The provisions in this rule affect the following areas: 1) The 
elimination of enhanced funding; 2) revisions to the time frames for 
completing individual case reviews; 3) extending the time frames in the 
procedures for households that refuse to cooperate with QC reviews; 4) 
procedures for adjusting liability determinations following appeal 
decisions; and 5) conforming and technical changes. (02-015)


Statement of Need:


The rule is needed to implement several food stamp quality control 
provisions of Public Law 107-171 The Farm Security and Rural Investment 
Act of 2002. Elimination of enhanced funding is required by the Act. 
The Act also requires the Department to propose rules for adjusting 
liability determinations following appeals decisions. The remaining 
changes are either conforming changes resulting from the required 
changes or policy changes already in effect but not updated in the 
regulations.


Summary of Legal Basis:


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


Alternatives:


This rule deals in part with changes required by title IV of Public Law 
107-171 The Farm Security and Rural Investment Act of 2002. The 
Department has no discretion in eliminating enhanced funding for fiscal 
years 2003 and beyond. The provision addressing results of appeals is 
required to be regulated by Public Law 107-171. The remaining changes 
amend existing regulations and are required to make technical changes 
resulting from these changes or to update policy consistent with 
current requirements.


Anticipated Cost and Benefits:


The provisions of this rule are not anticipated to have any impact on 
benefit levels. The provisions of this rule are anticipated to reduce 
administrative costs.


Risks:


The FSP provides nutrition assistance to millions of Americans 
nationwide. The quality control system measures the accuracy of States 
providing food stamp benefits to the program recipients. This rule is 
intended to implement some of the quality control provisions of title 
IV of Public Law 107-171 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 revise the system for determining 
State agency liabilities and sanctions for high payment error rates 
following appeal decisions.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/04
NPRM Comment Period Ends                                       05/00/04
Final Action                                                   12/00/04
Final Action Effective                                         01/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State

[[Page 72439]]

Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD37
_______________________________________________________________________
USDA--FNS

                              -----------

                            FINAL RULE STAGE

                              -----------

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


Summary of Legal Basis:


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


Alternatives:


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


Anticipated Cost and Benefits:


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


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


Risks:


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                                             05/00/04
Interim Final Rule Effective                                   06/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State


Federalism:


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


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC24

[[Page 72440]]

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


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 106-387


CFR Citation:


7 CFR 273.8; 7 CFR 273.9


Legal Deadline:


None


Abstract:


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


Statement of Need:


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


Summary of Legal Basis:


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


Alternatives:


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


Anticipated Cost and Benefits:


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


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 51932                                    08/29/03
NPRM Comment Period End                                        10/28/03
Final Action                                                   08/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State


URL For Public Comments:
www.fns.usda.gov/fsp/rules/regulations/default.htm
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD13
_______________________________________________________________________
USDA--FNS
20. FSP: NON-DISCRETIONARY QUALITY CONTROL PROVISIONS OF TITLE IV OF 
PUBLIC LAW 107-171
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 interim rule will implement several quality control changes to the 
Food Stamp Act required by sections 4118 and 4119 of title IV of the 
Farm Security and Rural Investment Act of 2002 (Public Law 107-171). 
The provisions in this rule affect 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. (02-014)


Statement of Need:


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


Summary of Legal Basis:


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


Alternatives:


This interim rule deals with changes required by Public Law 107-171, 
the Farm Security and Rural Investment Act of 2002. The Department has 
no discretion in implementing these provisions of that law. The 
provisions in this rule are effective for the fiscal year 2003 quality 
control review period and must be implemented by FNS and State agencies 
during fiscal year 2003.


Anticipated Cost and Benefits:


The provisions of this rule are not anticipated to have any impact on 
benefit levels or administrative costs.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru68 FR 59519                                    10/16/03
Interim Final Rule Effective                                   12/15/03
Interim Final Rule Comment Period End                          01/14/04
Final Action                                                   10/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, Local, State

[[Page 72441]]

Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
3101 Park Center Drive
Room 918
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD31
_______________________________________________________________________
USDA--Food Safety and Inspection Service (FSIS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

21. PERFORMANCE STANDARDS FOR BACON
Priority:


Other Significant


Legal Authority:


21 USC 601 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 to produce pumped bacon 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 to 695), a meat or 
meat food product is adulterated ``if it bears or contains any 
poisonous or deleterious substance that 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 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 
currently address nitrosamines as hazards reasonably likely to occur 
may incur some costs. Also, establishments that choose to test their 
products for nitrosamines after this rule becomes effective may incur 
some costs. Because this rule provides establishments the flexibility 
to develop new procedures for producing bacon, this rule may result in 
profits to processors who develop cheaper means of producing product or 
who develop a pumped bacon product with wide consumer appeal.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           07/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Dr. Daniel L. Engeljohn
Executive Associate, Office of Policy & Program Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 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
22. 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

[[Page 72442]]

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 to 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 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

[[Page 72443]]

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 enteritis 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                                                           06/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, State


Federalism:


 Undetermined


Agency Contact:
Dr. Daniel L. Engeljohn
Executive Associate, Office of Policy & Program Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720ndash;5627
Fax: 202 690-0486
Email: [email protected]
RIN: 0583-AC58
_______________________________________________________________________
USDA--FSIS
23. ELIMINATION OF CHILLING TIME AND TEMPERATURE REQUIREMENTS FOR 
READY-TO-COOK POULTRY
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 to 470).


Alternatives:


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


Anticipated Cost and Benefits:


Poultry processors would gain the flexibility to choose the best 
processing techniques and procedures for achieving production 
efficiencies, meeting HACCP food safety objectives, and preventing 
economic adulteration of raw product with retained water in amounts 
greater than unavoidable for food-safety purposes. They would be able 
to operate with a wider range of chilling temperatures consistently 
with the requirements of the PR/HACCP regulations. The poultry products 
industry could achieve energy efficiencies resulting in annual savings 
of as much as $2.8 million. The industry could also reduce carcass 
``dwell times'' in immersion chillers and thereby reduce the amount of 
water absorbed and retained by the carcasses. The reduction in dwell 
time might enable some establishments, particularly those currently 
operating at the throughput capacity of their chillers, to increase 
production by installing additional evisceration lines.


Poultry establishments would therefore be able to operate more 
efficiently to provide consumers with product that is not adulterated. 
FSIS also would gain some flexibility by being able to reallocate some 
inspection resources from measuring the temperature of chilled birds to 
such activities as HACCP system verification.


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


Risks:


None


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses

[[Page 72444]]

Government Levels Affected:


None


Agency Contact:
Dr. Daniel L. Engeljohn
Executive Associate, Office of Policy & Program Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 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
24. 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, neurological 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.


Summary of Legal Basis:


Under the Federal Meat Inspection Act (21 U.S.C. 601 to 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

[[Page 72445]]

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                                                           09/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Dr. Daniel L. Engeljohn
Executive Associate, Office of Policy & Program Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 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
25. [bull] MEAT PRODUCED BY ADVANCED MEAT/BONE SEPARATION MACHINERY AND 
MEAT RECOVERY SYSTEMS
Priority:


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


Legal Authority:


21 USC 601 to 695


CFR Citation:


9 CFR 301.2; 9 CFR 318.24 (Revision); 9 CFR 3


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 1994. 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 to 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

[[Page 72446]]

databases 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                                                           12/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Dr. Daniel L. Engeljohn
Executive Associate, Office of Policy & Program Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5627
Fax: 202 690-0486
Email: [email protected]
RIN: 0583-AD00
_______________________________________________________________________
USDA-FSIS

                              -----------

                            FINAL RULE STAGE

                              -----------

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


Economically Significant


Unfunded Mandates:


Undetermined


Legal Authority:


21 USC 451 et seq; 21 USC 601 et seq


CFR Citation:


9 CFR 317; 9 CFR 381; 9 CFR 430


Legal Deadline:


None


Abstract:


FSIS has proposed to establish pathogen reduction performance standards 
for all ready-to-eat (RTE) 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 
standards already in place for certain 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.


The proposal also contained provisions addressing Listeria 
monocytogenes in RTE products. An Interim Final Rule on this subject 
was published June 6, 2003 (68 FR 34208).


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


Alternatives:


As an alternative to all of the proposed requirements, FSIS considered 
taking no action. As alternatives to the proposed performance standard 
requirements, FSIS considered end-product testing and requiring ``use-
by'' date labeling on ready-to-eat products.


Anticipated Cost and Benefits:


Benefits are expected to result from less contaminated products 
entering commercial food distribution channels as a result of improved 
sanitation and process controls and in-plant verification. FSIS 
believes that the benefits of the rule would exceed the total costs of 
implementing its provisions.


The main provisions of the proposed rule are: Lethality performance 
standards for Salmonella and E. coli 0157:H7 and stabilization 
performance standards for C. perfringens that firms must meet when 
producing RTE meat and poultry products. Most of the costs of these 
requirements would be associated with one-time process performance 
validation in the first year of implementation of the rule and with 
revision of HACCP plans. Total industry-wide costs are estimated to be 
$7.1 million. Benefits are expected to result from the entry into 
commercial food distribution channels of product

[[Page 72447]]

with lower levels of contamination resulting from improved in-plant 
process verification and sanitation.


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
NPRM Comment Period End                                        09/10/01
Final Action                                                   12/00/03
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Undetermined


Agency Contact:
Dr. Daniel L. Engeljohn
Executive Associate, Office of Policy & Program Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 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
27. 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 will require nutrition labeling for the major cuts of single-
ingredient, raw meat and poultry products, either on their label or at 
their point-of-purchase. FSIS will also require nutrition information 
on the label of ground or chopped meat and poultry products. The 
requirements for ground or chopped products will be consistent with 
those for multi-ingredient products.


In this final rule, FSIS will also provide that when a ground or 
chopped product does not meet the regulatory criteria to be labeled 
``low fat,'' a lean percentage claim may be included on the 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 will 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 has concluded 
that these products would be misbranded.


Because consumers cannot easily estimate the level of fat in ground or 
chopped meat and poultry products and because producers are able to 
formulate precisely the fat content of ground or chopped products, FSIS 
has concluded that ground or chopped meat and poultry products that do 
not bear nutrition information on their labels would also be 
misbranded.


Finally, FSIS will 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 will include these provisions in the 
final nutrition labeling regulations because many consumers have become 
accustomed to this labeling on ground beef products and because 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 to 695) and the Poultry Products Inspection Act (21 U.S.C. 
451 to 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 will include the equipment for making labels, labor, and 
materials used for labels for ground or chopped products. The cost of 
providing nutrition labeling for the major cuts of single-ingredient, 
raw meat and poultry products should not be significant, because retail 
establishments would have the option of providing nutrition information 
through point-of-purchase materials.


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.


FSIS has concluded that the quantitative benefits will exceed the 
quantitative costs of the rule.


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
Interim Final Rule                                             12/00/03
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


None


Agency Contact:
Robert Post
Director, Labeling and Consumer Protection Staff
Depa

[[Page 72448]]

rtment of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
RIN: 0583-AC60
_______________________________________________________________________
USDA--Forest Service (FS)

                              -----------

                            FINAL RULE STAGE

                              -----------

28. NATIONAL FOREST SYSTEM LAND MANAGEMENT PLANNING
Priority:


Other Significant


Legal Authority:


16 USC et seq; 5 USC 301


CFR Citation:


36 CFR 219, subpart A


Legal Deadline:


None


Abstract:


The Forest Service proposed changes to the National Forest System Land 
and Resource Management Planning Rule adopted November 9, 2000. The 
proposed rule was published December 6, 2002 (67 FR 72770). The 
proposed changes are a result of a review conducted by Forest Service 
personnel at the direction of the Office of the Secretary.


The final rule shall respond to internal review and comments received 
after the draft rule published December 6, 2002. This proposed rule is 
intended to improve upon the 2000 rule by providing a planning process 
that is more readily understood, is within the Agency's capability to 
implement, is within anticipated budgets and staffing levels, and 
recognizes the programmatic nature of planning.


Statement of Need:


The President's environmental program includes natural resource 
planning for all units of the National Forest System. In support of 
that effort, the Forest Service is adopting a final rule at 36 CFR part 
219, subpart A, to revise the land management planning rule, published 
on November 9, 2000, governing how future changes in land management 
planning direction will be made and how those changes will be 
documented. The proposed rule was published in the Federal Register on 
December 6, 2002, for a 90-day public comment period. The comment 
period was extended 30 days to April 7, 2003. The proposed rule 
continued to support the major principles of the 2000 rule, which are 
the underlying concepts of sustainability, monitoring and evaluation, 
collaboration, and use of science. The proposed rule, however, improved 
the clarity of the 2000 rule, characterized planning as a continuous 
process, offered two options to provide for diversity of plant and 
animal communities, and provided for plan analysis to be categorically 
excluded from National Environmental Policy Act (NEPA) documentation. 
The Agency received over 195,000 comments on the proposed rule. 
Consideration of these comments should lead to a final rule that better 
enables the Forest Service to be good land stewards by providing the 
clean air and water and wildlife protection the public expects. This 
goal would be accomplished by shifting from a complex, cumbersome, and 
expensive up front planning process, to a streamlined process that 
better involves the public, and shifts resources to land management and 
continual monitoring and evaluation.


Summary of Legal Basis:


The Forest and Rangeland Renewable Resources Planning Act of 1974 (88 
Stat. 476 et seq.), as amended by the National Forest Management Act of 
1976 (NFMA) (90 Stat. 2949 et seq.), requires the Secretary to 
promulgate regulations under the principles of the Multiple-Use 
Sustained-Yield Act of 1960 that set out the process for the 
development and revision of land management plans (16 U.S.C. 1604(g)).


Alternatives:


The Forest Service considered and compared the final planning rule to 
both the 1982 and the 2000 planning regulations. Land management plans 
prepared under the 1982 rule were difficult to prepare, took 5 to 7 
years to complete, and required detailed analytical requirements that 
were of limited use due to the high degree of uncertainty of the 
projections. The 2000 planning rule requires a number of detailed 
analytical requirements, lacks clarity regarding many of these 
requirements, is not flexible enough, and lacks recognition of the 
limits of agency budgets and personnel needed to implement it.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits focused on 
key activities in land and resource management planning for which costs 
could be estimated under the 1982, 2000, and final planning rules. 
Based on costs that can be quantified, this final rule is estimated to 
save an average of $9.8 million annually, compared to the expected 
costs under the 1982 rule, and about $36 million per year compared to 
the 2000 rule. The discounted value of the cost savings over the 15-
year planning horizon is estimated to be $92 million for the final rule 
when compared to the 1982 rule and approximately $324 million when 
compared to the 2000 rule.


In addition to the anticipated cost savings, numerous intangible 
benefits are expected to result from the final rule. The overall goal 
of the final rule is to develop a planning framework that fosters 
stewardship of the National Forest System lands and improves the 
likelihood of contributing toward the ecological, social, and economic 
components of sustainability. Better decisions provide sustained goods, 
services, and values without impairment of the health of the land. 
These improvements will be based on better collaboration with the 
public, improved monitoring and evaluation, integration of science, and 
a more flexible process that reduces the burden on both the public and 
the Agency. A planning process that addresses public concerns and leads 
to improved health of the public lands has value beyond the cost 
savings estimated in the analysis.


Risks:


The final planning rule will help to reduce the risks of natural 
resource management on National Forest System lands by strengthening 
the Forest Service's ability to respond quickly and effectively to a 
variety of continually changing issues, such as the development of new 
scientific information, new listing of species, the effects of 
wildfire, changes in demographics or the economy, and unforeseen 
effects of plan implementation activities. The final planning rule 
allows for a more flexible approach to planning and reducing risks by 
providing for a continual and adaptive planning cycle involving on-the-
ground project proposal, analysis, and implementation; monitoring and 
evaluation; and plan adjustment. The final planning rule would allow 
flexible implementation of projects to avoid and reduce risks; for 
example, projects to implement the Agency's hazardous fuels reduction 
program.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 72770                                    12/06/02
NPRM Comment Period End                                        03/24/03
Final Action                                                   11/00/03
Final Action Effective                                         12/00/03

[[Page 72449]]

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Andria D. Weeks
Regulatory Analyst
Department of Agriculture
Forest Service
MS 1134
ATTN: ORMS, D&R
1400 Independence Avenue SW
Washington, DC 20250
Phone: 703 605-4610
Fax: 703 605-5111
Email: [email protected]
RIN: 0596-AB86
_______________________________________________________________________
USDA--Rural Business-Cooperative Service (RBS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

29. [bull] NATIONAL SECURITY EMERGENCY
Priority:


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


Legal Authority:


7 USC 1963


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


The Rural Business-Cooperative Service (RBS) proposes to streamline 
procedures for loans and grants for existing business and industry 
direct and guarantee loan programs. This rulemaking will also establish 
emergency regulations for the community facilities program currently 
administered within the Rural Housing Service (RHS).


We are concurrently undertaking to prepare draft emergency legislation 
to expand both the nature of authorized financial assistance and the 
eligible applicant pool to assure maximum flexibility on the part of 
the Secretary in helping to alleviate the economic distress in rural 
areas when a national security emergency is declared. In the event this 
standby legislation is enacted, the scope of this rulemaking will be 
modified accordingly.


The proposed rule will include the following changes to current 
procedures for existing programs:


--The proposed rule will provide that the Agency may waive credit 
requirements that would otherwise apply to processing direct loans and 
guarantees.


--The proposed rule will provide that the Agency may substitute a 
``best efforts'' test in allowing substitutions for application 
requirements. For example, if credit history documentation has been 
destroyed or is not available, an affidavit from a creditor familiar 
with the borrower's payment history prior to the emergency might 
suffice.


--We anticipate that environmental review requirements will be 
streamlined--most notably in the areas of public notice and comment 
periods.


--We will substitute ``to the best of my knowledge'' certifications for 
firm documentation requirements where reasonable and appropriate.


--We will provide exceptions to the requirements of the Paperwork 
Reduction Act that allow flexibility to USDA in the form and nature of 
information collections allowed under emergency conditions.


Statement of Need:


Executive Order 12656 directs the Secretary of Agriculture to develop 
plans to provide for the continuation of agricultural production, food 
processing, storage, and distribution through the wholesale level in 
national security emergencies and to provide for the domestic 
distribution of seed, feed, fertilizer, and farm equipment to 
agricultural producers.


In section 14(a) of USDA Departmental Regulation 1800-1 (Departmental 
Emergency Programs Responsibilities), the Secretary provides that RBS 
will, in cooperation with other government agencies at all levels: 
Promote economic development in affected rural areas by developing 
strategies that respond to the conditions created by an emergency; 
provide financial aid for needed community facilities; and provide 
business development assistance.


Absent supplemental legislation, if an emergency occurs, the financial 
resources that RBS will be able to deploy (expedited or not) will be a 
function of remaining appropriation levels across a spectrum of stove-
piped program authorizations--where the types of assistance, eligible 
borrowers and eligible purposes must all be administered in accordance 
with different requirements. The best an emergency regulation can do 
under those circumstances is provide for expedited deployment of these 
remaining financial resources.


The intent and expectation is that the rulemaking will ultimately 
reflect supplemental legislation that accords maximum discretion to the 
Secretary in alleviating the capital needs of businesses in rural areas 
created by the emergency.


Summary of Legal Basis:


Section 323 of the Consolidated Farm and Rural Development Act [9 
U.S.C. 1963] (Con Act) provides for direct or insured emergency loans 
for any purpose already authorized under subtitles A or B of the Con 
Act.


Alternatives:


In the case of a national security emergency, without this rulemaking, 
RBS would strive to execute the current programs within the then 
remaining appropriation levels as expeditiously as possible.


As discussed above, we expect to pursue standby legislation that will 
provide authorization for both grant and loan authority, a broad 
spectrum of eligible purposes and applicants, and include 
appropriations as well. This standby legislation would be effective as 
and when a national security emergency were declared and pertain only 
to the geographic areas affected.


Anticipated Cost and Benefits:


Absent standby emergency legislation that augments existing program 
budget authority, there is no incremental budget impact presented by 
this rulemaking. This regulation will only be effective upon the 
declaration of a National Security Emergency as contemplated by 
Executive Order 12656.


The streamlining of some processing requirements will facilitate faster 
deployment of RBS program funds, and in the case of RHS, the remaining 
available appropriations for essential community facilities.


Risks:


The greatest risk associated with streamlined processing and waivers of 
credit evaluation criteria is that of nonperforming loans resulting 
from this

[[Page 72450]]

emergency regulation that otherwise would not have been made in the 
first place. The historic experience of RBS in the case of several 
natural disasters, however, is that the loan portfolios made under 
challenging conditions have actually out-performed the rest of the 
portfolio. It is not possible to know how future emergency loan 
performance will compare with the rest of the loan portfolio exposure.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Bill Hagy
Deputy Administrator, Business Programs
Department of Agriculture
Rural Business-Cooperative Service
Room 5050/Stop 3220
Room 5811/Stop 3220
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-7287
Fax: 202-690-0097
Email: [email protected]
RIN: 0570-AA48
_______________________________________________________________________
USDA--RBS
30. [bull] RENEWABLE ENERGY SYSTEMS AND ENERGY EFFICIENCY IMPROVEMENTS
Priority:


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


Legal Authority:


7 USC 8106


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


Section 9006 of the Farm Bill directs the implementation of a direct 
and guaranteed loan and grant program for renewable energy systems and 
energy efficiency improvements for farmers, ranchers, and rural small 
businesses. For fiscal year (FY) 2003, a Notice of Funds Availability 
was published on April 8 for the grant program.


The proposed rule will establish regulations to implement the direct 
and guaranteed loan and grant program. These regulations will allow for 
the integration of all program authorities and permit full attention to 
all of the potential contingencies and issues.


Statement of Need:


Section 9006 of the Farm Security and Rural Investment Act of 2002 
(Act) requires that the Secretary establish a program to ``make loans, 
loan guarantees, and grants to farmers, ranchers, and rural small 
businesses to purchase renewable energy systems and make energy 
efficiency improvements. The Act directs that in funding such projects, 
USDA direct and guaranteed loans and grant financing is not to exceed 
50 percent of the cost of the activity, and grant-only funding is not 
to exceed 25 percent of the cost of the activity. For 5 years, 
beginning in FY 2003, the Commodity Credit Corporation is to provide 
$23 million in budget authority annually for these purposes. Since this 
is a new program, guidelines need to be established concerning the 
nature of the program and the delivery model to be used, so that a full 
set of implementation policies can be developed. The Office of General 
Counsel has mandated that regulations must be in place to operate the 
program.


Summary of Legal Basis:


The Act mandates that assistance under section 9006 of the Act begin in 
FY 2003, with funds from the Commodity Credit Corporation, and continue 
for 5 fiscal years.


Alternatives:


None.


Anticipated Cost and Benefits:


The proposed action will have no financial impact on the public or the 
Government. However, it will have a positive impact for farmers, 
ranchers, and rural small businesses; improve the delivery of USDA's 
energy-oriented assistance; and be in the best interest of the 
Government and public.


Risks:


The only risk is, if the regulation is not done, fiscal year 2004 
funding would be lost.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Undetermined


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Diane Berger
Loan Specialist
Department of Agriculture
Rural Business-Cooperative Service
Room 6867
Room 6868/Stop 3225
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-2383
Fax: 202-720-2213
Email: [email protected]
RIN: 0570-AA50
_______________________________________________________________________
USDA--Natural Resources Conservation Service (NRCS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

31. CONSERVATION SECURITY PROGRAM
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


16 USC 3838


CFR Citation:


7 CFR 1470


Legal Deadline:


None


Abstract:


Under the Conservation Security Program (CSP) NRCS is authorized to 
provide financial and technical assistance to owners and operators of 
agricultural operations to promote conservation and improvement of the 
quality of soil, water, air, energy, plant and animal life, and other 
conservation purposes.


Statement of Need:


USDA intends that CSP will recognize those farmers and ranchers, the 
land stewards, who meet the highest

[[Page 72451]]

standards of conservation and environmental management. By managing all 
of the natural resources on their farms and ranches in a sustainable 
fashion to these high standards, stewards of the land benefit 
themselves, their communities, and society as a whole. CSP can be an 
important tool for those stewards and others who strive towards the 
highest standards of conservation and environmental management. CSP 
helps sustain the economic well-being of those farmers and ranchers who 
reach this pinnacle of good land stewardship and enhance the ongoing 
production of clean water and clean air on their farms and ranches, 
which are valuable commodities to all Americans.


The fundamental philosophy and intent of CSP is to support ongoing 
conservation stewardship of working agricultural lands by providing 
payments and assistance to producers to maintain and enhance the 
condition of the resources. To implement the Secretary's vision, the 
program will reward owners and operators of agricultural lands for 
their conservation stewardship efforts and assist them with the 
implementation and maintenance of additional conservation measures that 
can improve the natural resource conditions of their agriculture 
operations. CSP particularly targets producers and activities that can 
provide the greatest additional benefits for the resource concerns 
identified in this rule and in CSP signup announcements. NRCS is 
additionally encouraging those who do not meet the sign-up requirements 
for CSP to initiate a review of the natural resource conditions on 
their land and begin or continue moving toward achieving the minimum 
conservation requirements to enter CSP at a later signup. Other USDA 
programs may be available for technical or financial assistance to help 
them achieve their resource management goals.


Summary of Legal Basis:


The Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171, 
May 13, 2002) (the Act) amended the Food Security Act of 1985 (16 
U.S.C. 3801 et seq.) to authorize the Conservation Security Program 
(CSP). The program is administered by USDA's Natural Resources 
Conservation Service (NRCS). The CSP is a voluntary program that 
provides financial and technical assistance to producers who advance 
the conservation and improvement of soil, water, air, energy, plant, 
and animal life and other conservation purposes on tribal and private 
working lands. Such lands include cropland, grassland, prairie land, 
improved pasture, and range land, as well as forested land and other 
non-cropped areas that are an incidental part of the agriculture 
operation.


As originally enacted, the Conservation Security Program was an 
entitlement program where many producers would have received payments 
if they were eligible. Subsequent to the enactment of the 2002 Act, the 
Omnibus Bill of 2003 amended the Act to limit CSP's total expenditures 
to a total of $3.77 billion over 11 years (fiscal year 2003 through 
fiscal year 2013). When developing the regulations to implement CSP, 
USDA confronted several challenges. The greatest challenge, however, 
was to design a new conservation entitlement program with a cap on its 
total expenditures over multiple years. Statute did not provide 
direction as to how the Secretary should implement a broad entitlement 
program with the statutory fiscal constraints.The limits imposed by the 
budget cap greatly reduce the potential scope of the program. For 
example, USDA's Economic Research Service (ERS) estimates that over 1.8 
million farms and ranches may be eligible for CSP, using the land 
eligibility criteria found in the authorizing legislation. If all of 
these agricultural operations were enrolled, the cost of the program 
would exceed the $3.77 billion cap potentially in the first sign-up. In 
contract, NRCS estimates that the budget cap would allow less than 
50,000 total agricultural operations to participate over the life of 
the program. Estimates derived from a variety of analyses indicate that 
the average Tier III contract, based on nationally averaged data, could 
be near $15,000 per year. If contracts were an average of 7 years in 
duration, the statutory funding could support an estimated 30,000 Tier 
III contracts. The average Tier I and Tier II contracts could be near 
$7,000 annually. If contracts were to average 5 years in duration, the 
statutory funding could support an estimated 90,000 Tier I and II 
contracts.


Furthermore, NRCS expects that a large number of producers will seek 
participation in CSP and ask for assistance to determine their 
potential eligibility for the program. Thus the statutory cap on 
technical assistance of 15 percent becomes another limiting factor for 
implementing CSP. By law, NRCS cannot incur technical assistance costs 
for NRCS employees or approved technical assistance providers in excess 
of 15 percent of the available funds.


Alternatives:


NRCS Preferred Approach:


1. Limit sign-ups: Conduct periodic CSP sign-ups.


2. Eligibility: Criteria should be sufficiently rigorous to ensure that 
participants are committed to conservation stewardship. Additionally, 
eligibility criteria should ensure that the most pressing resource 
concerns are addressed.


3. Contracts requirements should be sufficiently rigorous to ensure 
that participants undertake and maintain high levels of stewardship.


4. Prioritize funding to ensure that those producers with the highest 
commitment to conservation are funded first.


5. Structure payments to ensure that environmental benefits will be 
achieved.


Alternative Approaches:


1. Prioritize funding based on environmental considerations (e.g., high 
priority watersheds) with consideration given to past historical 
conservation.


2. Apportion the limited budget according to a formula of some kind, 
for example by discounting each participant's contract payments equally 
(i.e., prorate payments).


3. Close signup once available fund are exhausted (i.e., first come, 
first served).


4. Limit the number of tiers of participation offered.


5. Only allow historic stewards to participate-only those who have 
already completed the highest conservation achievement would be funded.


Anticipated Cost and Benefits:


NRCS developed a simulation model to analyze CSP benefits and costs. 
The model assesses producer participation and the overall benefits and 
costs to society associated with that participation. The model is based 
on a series of composite farms, replicating the process of calculating 
the CSP participation decision. Given farm-level estimates of 
participation, enrolled acreage, payments, and costs, the model 
estimates on-site and environmental (off-site) benefits, net economic 
costs, Government costs, Government-to-producer transfer payments, net 
benefit to society, and the benefit-cost ratio.

[[Page 72452]]

The model calculates the overall CSP payment by calculating several 
payment components individually, and then by summing the results of: 
The base payment, cost-sharing for installation of new structural 
practices and adoption of new land management practices, cost-sharing 
for maintenance of existing structural and land management practices, 
and enhancement payments. The Net Present Value (NPV) of each payment 
is determined by a payment rate per acre, the number of acres to which 
the payment applies, contract years in which the payment is made (i.e., 
whether the payment is made on a one-time or annual basis), discounted 
to the present using a 7 percent annual discount rate. Payments for 
structural and land management practices were calculated using a 
methodology similar to that used for the Environmental Quality 
Incentives Program (EQIP) Benefit/Cost Analysis, Final Report, May 29, 
2003.


Although the analysis provides estimates of the social net benefits of 
each alternative examined, its primary value is to illustrate the 
relative order of the identified alternatives, rather than provide 
accurate estimates of the costs and benefits. NRCS based its estimates 
on a number of assumptions because of substantial data gaps. There is, 
for example, no available information on the benefits associated with 
major program elements, such as enhancement activities above and beyond 
the non-degradation level. Instead, the RIA used estimates generated 
from experience with EQIP, CRP, and other USDA conservation programs. 
NRCS also assumes that producers would enroll in CSP if the program 
provided any positive net benefit to them (i.e., even as small as $1). 
This assumption does not take into consideration producers' cash flow 
constraints, which along with other factors could affect participation. 
Since the analysis does not have information on the behavioral response 
of producers to the incentives provided by CSP, the benefits analysis 
provided in the RIA is largely a hypothetical construct and does not 
reflect the benefits of the proposed program and the identified 
alternatives. NRCS intends to refine the analysis for the final rule.


Risks:


By issuing the proposed rule, NRCS builds upon the public input it 
received during the comment period associated with its ANPRM and is 
obtaining additional public comment on the implementation of a new, 
innovative conservation program. The proposed rule provides the public 
an opportunity to participate in the NRCS formation of program policies 
and procedures prior to NRCS publishing a final rule for the program.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Martha Joseph
Resource Conservationist
Department of Agriculture
Natural Resources Conservation Service
Room 6027-S
P.O. Box 2890
Washington, DC 20013
Phone: 202 720-7157
Fax: 202 720-2143
Email: [email protected]
RIN: 0578-AA36
BILLING CODE 3410-90-S

[[Page 72453]]

DEPARTMENT OF COMMERCE (DOC)
Statement of Regulatory and Deregulatory Priorities
 Enhancing long-term economic growth is a central focus of the 
President's policies and priorities. The mission of the Department of 
Commerce is to promote job creation, economic growth, technological 
competitiveness, sustainable development, and improved living standards 
for all Americans by working in partnership with businesses, 
universities, communities, and workers to:
Build for the future and promote U.S. economic competitiveness in the 
global marketplace by strengthening and safeguarding the Nation's 
economic infrastructure;
Keep America competitive with cutting-edge science and technology and 
an unrivaled information base; and
Provide effective management and stewardship of our Nation's resources 
and assets to ensure sustainable economic opportunities.
The DoC mission statement, containing our three strategic themes, 
provides the vehicle for understanding the Department's aims, how they 
interlock, and how they are to be implemented through our programs. 
This statement was developed with the intent that it serve as both a 
statement of departmental philosophy and as the guiding force behind 
the Department's programs
 The importance that this mission statement and these strategic themes 
have for the Nation is amplified by the vision they pursue for 
America's communities, businesses, and families. Commerce is the 
smallest Cabinet agency, yet our presence is felt, and our 
contributions are found, in every State.
 The DOC touches Americans, daily, in many ways--we make possible the 
weather reports that all of us hear every morning; we facilitate the 
technology that all of us use in the workplace and in the home each 
day; we support the development, gathering, and transmitting of 
information essential to competitive business; we make possible the 
diversity of companies and goods found in America's (and the world's) 
marketplace; and we support environmental and economic health for the 
communities in which Americans live.
 The DOC has a clear and powerful vision for itself, for its role in 
the Federal Government, and for its roles supporting the American 
people, now and in the future. We confront the intersection of trade 
promotion, civilian technology, economic development, sustainable 
development, and economic analysis, and we want to provide leadership 
in these areas for the Nation.
 We work to provide programs and services that serve our country's 
businesses, communities, and families, as initiated and supported by 
the President and the Congress. We are dedicated to making these 
programs and services as effective as possible, while ensuring that 
they are being delivered in the most cost-effective ways. We seek to 
function in close concert with other agencies having complementary 
responsibilities so that our collective impact can be most powerful. We 
seek to meet the needs of our customers quickly and efficiently, with 
programs, information, and services they require and deserve.
 As a permanent part of the Federal Government, but serving an 
Administration and Congress that can vary with election results, we 
seek to serve the unchanging needs of the Nation, according to the 
priorities of the President and the Congress. The President's 
priorities for the Department range from issues concerning the economy 
to the environment. For example, the President directs the Department 
to promote electronic commerce activities; encourage open and free 
trade; represent American business interests abroad; and assist small 
businesses to expand and create jobs. We are able to address these 
priorities effectively by functioning in accordance with the 
legislation that undergirds our programs and by working closely with 
the President and the committees in Congress, which have programmatic 
and financial oversight for our programs.
 The Department has taken steps to ensure that all of the President's 
priorities, particularly those that concern small business, are 
implemented. On August 13, 2002, the President issued Executive Order 
13272, which directs the Department to take appropriate account of the 
potential impact on small businesses, small governmental jurisdictions, 
and small organizations during the rulemaking process. In accordance 
with the Executive order, the Department published guidelines that 
establish procedures and policies to promote compliance with the 
Executive order and the Regulatory Flexibility Act. This guidance 
ensures that the Department properly considers the impact of its rules 
on small entities prior to implementation.
 The DOC also promotes and expedites American exports, helps nurture 
business contacts abroad, protects U.S. firms from unfair foreign 
competition, and makes how-to-export information accessible to small 
and mid-sized companies throughout the Nation, thereby ensuring that 
U.S. market opportunities span the globe.
 The DOC encourages development in every community, clearing the way 
for private-sector growth by building and rebuilding economically 
deprived and distressed communities. We promote minority 
entrepreneurship to establish businesses that frequently anchor 
neighborhoods and create new job opportunities. We work with the 
private sector to enhance competitive assets.
 As the Nation looks to revitalize its industries and communities, the 
DOC works as a partner with private entities to build America with an 
eye on the future. Through technology, research and development, and 
innovation, we are making sure America continues to prosper in the 
short-term, while also helping industries prepare for long-term 
success.
 The DOC's considerable information capacities help businesses 
understand clearly where our national and world economies are going and 
take advantage of that knowledge by planning the road ahead. Armed with 
the Department's economic and demographic statistics, businesses can 
undertake the new ventures, investments, and expansions that make our 
economy grow.
 The DOC has instituted programs and policies that lead to cutting-
edge, competitive, and better paying jobs. We work every day to boost 
exports, to deregulate business, to help smaller manufacturers battle 
foreign competition, to advance the technologies critical to our future 
prosperity, to invest in our communities, and to fuse economic and 
environmental goals.
 The DOC is American business' surest ally in job creation, serving as 
a vital resource base, a tireless advocate, and its Cabinet-level 
voice.
 The Regulatory Plan directly tracks these policy and program 
priorities, only a few of which involve regulation of the private 
sector by the Department.
Responding to the Administration's Regulatory Philosophy and Principles
 The vast majority of the Department's programs and activities do not 
involve regulation. Of the Department's 12

[[Page 72454]]

primary operating units, only two--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. Of all the significant actions planned by the 
Department, NOAA plans to complete an action, entitled Amendment 13 to 
the Northeast Multispecies Fishery Management Plan (FMP), which rises 
to the level of ``most important'' of the Department's ``significant 
regulatory actions''. Further information on this action is provided 
below.
 Though not principally a regulatory agency, the DOC has long been a 
leader in advocating and using market-oriented regulatory approaches in 
lieu of traditional command-and-control regulations when such 
approaches offer a better alternative. All regulations are designed and 
implemented to maximize societal benefits while placing the smallest 
possible burden on those being regulated.
 The DOC is also refocusing on its regulatory mission by taking into 
account, among other things, the President's regulatory principles. To 
the extent permitted by law, all preregulatory and regulatory 
activities and decisions adhere to the Administration's statement of 
regulatory philosophy and principles, as set forth in section 1 of 
Executive Order 12866. Moreover, we have made bold and dramatic 
changes, never being satisfied with the status quo. We have emphasized, 
initiated, and expanded programs that work in partnership with the 
American people to secure the Nation's economic future. At the same 
time we have downsized, cut regulations, closed offices, and eliminated 
programs and jobs that are not part of our core mission. The bottom 
line is that, after much thought and debate, we have made many hard 
choices needed to make this Department ``state of the art.''
 The Secretary has prohibited the issuance of any regulation that 
discriminates on the basis of race, religion, gender, or any other 
suspect category and requires that all regulations be written so as to 
be understandable to those affected by them. The Secretary also 
requires that the Department afford the public the maximum possible 
opportunity to participate in departmental rulemakings, even where 
public participation is not required by law.
National Oceanic and Atmospheric Administration
 The National Oceanic and Atmospheric Administration (NOAA) establishes 
and administers Federal policy for the conservation and management of 
the Nation's oceanic, coastal, and atmospheric resources. It provides a 
variety of essential environmental services vital to public safety and 
to the Nation's economy, such as weather forecasts and storm warnings. 
It is a source of objective information on the state of the 
environment. NOAA plays the lead role in achieving the departmental 
goal of promoting stewardship by providing assessments of the global 
environment.
 Recognizing that economic growth must go hand-in-hand with 
environmental stewardship, the Department, through NOAA, conducts 
programs designed to provide a better understanding of the connections 
between environmental health, economics, and national security. 
Commerce's emphasis on ``sustainable fisheries'' is saving fisheries 
and confronting short-term economic dislocation, while boosting long-
term economic growth. The Department is where business and 
environmental interests intersect, and the classic debate on the use of 
natural resources is transformed into a ``win-win'' situation for the 
environment and the economy.
 Three of NOAA's major components, the National Marine Fisheries 
Services (NMFS), the National Ocean Service (NOS), and the National 
Environmental Satellite, Data, and Information Service (NESDIS), 
exercise regulatory authority.
 NMFS oversees the management and conservation of the Nation's marine 
fisheries, protects marine mammals, and promotes economic development 
of the U.S. fishing industry. NOS assists the coastal states in their 
management of land and ocean resources in their coastal zones, 
including estuarine research reserves; manages the Nation's national 
marine sanctuaries; monitors marine pollution; and directs the national 
program for deep-seabed minerals and ocean thermal energy. NESDIS 
administers the civilian weather satellite program and licenses private 
organizations to operate commercial land-remote sensing satellite 
systems.
 The Administration is committed to an environmental strategy that 
promotes sustainable economic development and rejects the false choice 
between environmental goals and economic growth. The intent is to have 
the Government's economic decisions guided by a comprehensive 
understanding of the environment. The Department, through NOAA, has a 
unique role in promoting stewardship of the global environment through 
effective management of the Nation's marine and coastal resources and 
in monitoring and predicting changes in the Earth's environment, thus 
linking trade, development, and technology with environmental issues. 
NOAA has the primary Federal responsibility for providing sound 
scientific observations, assessments, and forecasts of environmental 
phenomena on which resource management and other societal decisions can 
be made.
 In the environmental stewardship area, NOAA's goals include: 
rebuilding U.S. fisheries by refocusing policies and fishery management 
planning on increased scientific information; increasing the 
populations of depleted, threatened, or endangered species of marine 
mammals by implementing recovery plans that provide for their recovery 
while still allowing for economic and recreational opportunities; 
promoting healthy coastal ecosystems by ensuring that economic 
development is managed in ways that maintain biodiversity and long-term 
productivity for sustained use; and modernizing navigation and 
positioning services. In the environmental assessment and prediction 
area, goals include: modernizing the National Weather Service; 
implementing reliable seasonal and interannual climate forecasts to 
guide economic planning; providing science-based policy advice on 
options to deal with very long-term (decadal to centennial) changes in 
the environment; and advancing and improving short-term warning and 
forecast services for the entire environment.
Magnuson-Stevens Act Rulemakings
 Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-
Stevens Act) rulemakings concern the conservation and management of 
fishery resources in the U.S. 3-to-200-mile Exclusive Economic Zone 
(EEZ). Among the several hundred rulemakings that NOAA plans to issue 
in the Regulatory Plan year, a number of the preregulatory and 
regulatory actions will be significant. The exact number of such 
rulemakings is unknown, since they are usually initiated by the actions 
of eight regional Fishery Management Councils (FMCs) that are 
responsible for preparing fishery management plans (FMPs) and FMP 
amendments, and for drafting implementing regulations for each managed 
fishery. Once a

[[Page 72455]]

rulemaking is triggered by an FMC, the Magnuson-Stevens Act places 
stringent deadlines upon NMFS by which it must exercise its rulemaking 
responsibilities.
 While most of these rulemakings will be minor, involving only the 
opening or closing of a fishery under an existing FMP, one action 
concerning the Northeastern Multispecies Fishery Management Plan is of 
particular significance and we designate it as one of the ``most 
important'' of the Department's ``significant regulatory actions''. In 
this action NMFS plans to amend its regulations to implement provisions 
of Amendment 13 to the Northeast (NE) Multispecies Fishery Management 
Plan (FMP). The principal objectives of Amendment 13 include measures 
to implement a formal rebuilding program for overfished stocks and to 
end overfishing on those stocks where it is occurring and to bring the 
FMP into full compliance with the Magnuson-Stevens Act. In addition, 
this rule would implement provisions that respond to the requirements 
of the Court Orders in the lawsuits of Conservation Law Foundation, et 
al. v. Donald Evans, et al. (CLF v. Evans)and American Oceans Campaign, 
et al. v. William M. Daley, et al. (AOC v. Daley). Additional 
information concerning this rule is found below.
 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 
Executive 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 the Department's security-related trade and competitiveness 
programs. BIS plays a key role in challenging issues involving national 
security and nonproliferation, export growth, and high technology. The 
Bureau's continuing major challenge is combating the proliferation of 
weapons of mass destruction while furthering the growth of U.S. 
exports, which are critical to maintaining our leadership in an 
increasingly competitive global economy. BIS strives to be the leading 
innovator in transforming U.S. strategic trade policy and programs to 
adapt to the changing world.
Major Programs and Activities
 The Export Administration Regulations (EAR) provide for export 
controls on dual use goods and technology (primarily commercial goods 
that have potential military applications) not only to fight 
proliferation, but also to pursue other national security, short 
supply, and foreign policy goals (such as combating terrorism). 
Simplifying and updating these controls in light of the end of the Cold 
War has been a major accomplishment of BIS.
BIS is also responsible for:
Enforcing the export control and antiboycott provisions of the Export 
Administration Act (EAA), as well as other statutes such as the 
Fastener Quality Act. The EAA is enforced through a variety of 
administrative, civil, and criminal sanctions.
Analyzing and protecting the defense industrial and technology base, 
pursuant to the Defense Production Act and other laws. As the Defense 
Department increases its reliance on dual-use high technology goods as 
part of its cost-cutting efforts, ensuring that we remain competitive 
in those sectors and subsectors is critical to our national security.
Helping Ukraine, 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.

[[Page 72456]]

_______________________________________________________________________
DOC--National Oceanic and Atmospheric Administration (NOAA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

32. AMENDMENT 13 TO THE NORTHEAST MULTISPECIES FISHERY MANAGEMENT PLAN 
(FMP)
Priority:


Economically Significant


Legal Authority:


16 USC 1801 et seq


CFR Citation:


50 CFR 648


Legal Deadline:


Final, Judicial, May 1, 2004, Final.


Final, Statutory, Final.


Abstract:


This action would amend the FMP to address the Magnuson-Stevens Act 
requirement to implement a stock rebuilding program for all of the 
regulated multispecies. Management measures may include a days-at-sea 
reduction, gear reductions, and area management.


Statement of Need:


On December 28, 2001, a decision was rendered by the U.S. District 
Court for the District of Columbia on a lawsuit brought by the 
Conservation Law Foundation (CLF), Center for Marine Conservation, 
National Audubon Society and Natural Resources Defense Council against 
NMFS (CLF v. Evans, Case No. 00CVO1134, (D.D.C., December 28, 2001)). 
The lawsuit alleged that Framework Adjustment 33 to the FMP violated 
the overfishing, rebuilding, and bycatch provisions of the Magnuson-
Stevens Act (16 U.S.C 1801, et seq.) as amended by the Sustainable 
Fisheries Act (SFA). The court granted plaintiffs' motion for summary 
judgment on all counts, but did not impose a remedy. Instead, the court 
asked the parties to the lawsuit to propose remedies consistent with 
the court's findings. Shortly thereafter, several additional parties 
were allowed to intervene in the lawsuit for purposes of proposing the 
appropriate remedy. These parties (intervenors) included the States of 
Maine, New Hampshire, Massachusetts, and Rhode Island, and three 
industry groups. Additional background on the lawsuit is contained in 
the preambles to the interim rules published by NMFS on April 29, 2002 
(67 FR 21140), May 6, 2002 (67 FR 30331), and June 5, 2002 (67 FR 
38608), and in the proposed interim rule published July 1, 2002 (67 FR 
44139).


From April 5-9, 2002, plaintiffs, defendants and intervenors engaged in 
court-sponsored mediation to try to agree upon mutually acceptable 
short-term and long-term solutions to present to the court as an 
appropriate remedy. Although these discussions ended with no agreement, 
several of the parties continued mediation and filed a settlement 
agreement with the court on April 16, 2002. In addition to NMFS, the 
parties signing the agreement include CLF, which is one of the 
plaintiff conservation groups, all four state intervenors, and two of 
three industry intervenors.


In order to ensure the implementation of protective management measures 
by May 1, 2002, NMFS, notwithstanding that the court had then not yet 
issued its remedial order, filed an interim final rule with the Office 
of the Federal Register on April 25, 2002, for publication on April 29, 
2002. The interim final rule that was published on April 29, 2002, 
implemented measures identical to the short-term measures contained in 
the settlement agreement filed with the court.


On April 26, 2002, the court issued a remedial order that ordered the 
promulgation of two specific sets of management measures--one to be 
effective from May 1, 2002, to July 31, 2002, and the other from August 
1, 2002, until promulgation of Amendment 13 to the FMP. The court-
ordered measures for the first set of measures were, in the majority, 
identical with those contained in the settlement agreement and the 
measures contained in NMFS' April 29, 2002, interim final rule. 
However, the court-ordered measures included additional provisions and 
an accelerated schedule of effectiveness for all measures, which were 
not contained in either the settlement agreement or the April 29, 2002, 
interim final rule. According to the court, these additional provisions 
were included to strengthen the settlement agreement provisions ``in 
terms of reducing overfishing and minimizing bycatch without risking 
the lives of fishers or endangering the future of their communities and 
their way of life.'' Remedial order, p. 13. Further, the court ordered 
that NMFS publish in the Federal Register, as quickly as possible, an 
``amended interim rule and an amended second interim rule`` that would 
''include the departures from the Settlement Agreement incorporated in 
the Remedial Order.`` To comply with the court order, NMFS published a 
second interim final rule (amended interim rule) to modify the measures 
implemented through the April 29, 2002, interim final rule and to 
accelerate the effectiveness of the gear restrictions, as required by 
the remedial order. Because the court's remedial order was not entirely 
consistent with the terms of the settlement agreement, NMFS, CLF, and 
the intervenors filed motions for reconsideration with the court 
requesting that the court implement the terms of the settlement 
agreement without change.


On May 23, 2002, the court issued an order, in the case of CLF v. 
Evans, granting the motions for reconsideration on the basis that ``the 
important changes made by the Court in the complex and carefully 
crafted Settlement Agreement Among Certain Parties . . . would produce 
unintended consequences.`` The court ordered that the settlement 
agreement be implemented according to its terms; that the Secretary of 
Commerce (Secretary) publish an interim rule, effective no later than 
June 1, 2002, to reduce overfishing in the first quarter of the 2002-
2003 fishing year; that the Secretary publish another interim rule to 
be effective no later than August 1, 2002, to reduce overfishing 
beginning with the second quarter of the 2002-2003 fishing year, and 
continuing until implementation of Amendment 13 to the FMP, which 
complies with the overfishing, rebuilding, and bycatch provisions of 
the SFA; and that, no later than August 22, 2003, the Secretary 
promulgate such an amendment to the FMP. The court further ordered that 
the Secretary shall make public the most current scientific information 
to enable completion of the FMP Amendment no later than December 1, 
2002, provide at least 5 percent observer coverage, and inform the 
court of the steps taken to comply with the order no later than 
September 5, 2002. The order relating to observer coverage differs from 
the settlement agreement in that it requires a minimal level of 5 
percent at first and 10 percent by May 1, 2003, unless it can be 
established by scientific information that an increase is not 
necessary. NMFS implemented a program to provide at least 5 percent 
observer coverage in the multispecies fishery for the period August 1, 
2002, to April 30, 2003, and thereafter, at a level of at least 5 
percent depending on statistical need.


In response to the May 23, 2002, court order, on May 31, 2002, NMFS 
filed

[[Page 72457]]

an interim final rule with the Federal Register on June 5, 2002 (67 FR 
38608) that implemented regulations for the June 1 through July 31, 
2002, period, consistent with the settlement agreement. On July 1, 
2002, NMFS published a proposed interim rule (67 FR 44139) for measures 
ordered by the court to be effective August 1, 2002; public comments 
were accepted through July 16, 2002. The interim final rule published 
August 1, 2002 (67 FR 50292) implemented management measures for the 
period August 1, 2002, through the implementation of Amendment 13, in 
accordance with the settlement agreement and the remedial order. 
Amendment 13, which will bring the FMP into full compliance with the 
SFA, is under development by NMFS and the New England Fishery 
Management Council (Council) and was intended to be implemented by 
August 22, 2003. The interim final rule is an interim action necessary 
to reduce overfishing consistent with and pursuant to section 305(c) of 
the Magnuson-Stevens Act while Amendment 13 is being developed. Under 
the provisions of section 305(c)(3) of the Magnuson-Stevens Act, 
interim measures shall remain in effect for not more than 180 days 
after the date of publication, and may be extended by publication in 
the Federal Register for one additional period of not more than 180 
days, provided that the public has had an opportunity to comment on the 
interim measures. On January 22, 2003, NMFS published a notice of 
continuation of these regulations (68 FR 2919) announcing the 
continuation of the management measures to reduce overfishing through 
July 27, 2003. NMFS and two of the plaintiffs filed a motion with the 
court requesting an extension of the August 22, 2003, implementation 
schedule until May 1, 2004. The court granted an extension of the 
court--ordered timeline for Amendment implementation until May 1, 2004. 
On April 24, 2003, NMFS published a proposed emergency action (68 FR 
20097) requesting comments on measures to ensure that the regulations 
governing the Northeast Multispecies Fishery continued to be in 
compliance with the court's order. On June 27, 2003, NMFS published a 
final emergency rule (68 FR 38234) continuing most of the measures 
contained in the settlement agreement ordered by the court. This 
emergency action is necessary to ensure that there exist measures to 
reduce overfishing until implementation of Amendment 13.


Summary of Legal Basis:


The regulations implementing measures contained in the Northeast 
Multispecies FMP are governed by the Magnuson-Stevens Act. The 
Magnuson-Stevens Act mandates that action be taken if the size of a 
fish stock declines below a specified level or if the annual harvest 
rate is too high. Although the numbers of fish of many of the 15 
groundfish species (20 stocks) have increased substantially in recent 
years and harvest rates have gradually declined, for many stocks the 
rate of increase must be accelerated to comply with the law, and for 
other stocks the harvest rate must be reduced. As a result of the CLF 
v. Evans, a Federal judge ruled that the Northeast Multispecies FMP 
does not comply with the Magnuson-Stevens Act and ordered that 
Amendment 13 measures must bring the FMP into compliance with the 
Magnuson-Stevens Act. In addition to this lawsuit, Amendment 13 
includes alternatives to address the court--ordered remedy in the case 
of AOC v. Daley. In this case the Court ruled that elements of the 
amendment adopted to comply with the essential fish habitat provisions 
of the Magnuson-Stevens Act were not in compliance with the National 
Environmental Policy Act. Therefore, Amendment 13 will bring the 
Northeast Multispecies FMP into compliance with the Magnuson-Stevens 
Act and respond to the requirements of the court orders in the lawsuits 
of CLF v. Evans and AOC v. Daley.


Alternatives:


The principal objectives of Amendment 13 include rebuilding overfished 
stocks, ending overfishing, reducing unused effort in the fishery, 
addressing administrative issues, maintaining flexibility in the 
fishery, reducing bycatch, and minimizing the impact of the fishery on 
fish habitat and protected species such as whales and turtles. There 
are three major categories of impacts considered for each measure--
biological, economic, and social impacts. The impacts on bycatch, 
habitat, and enforcement are also considered. The public has 
opportunities to provide comments on the proposed alternatives under 
consideration. On August 29, 2003, the Notice of Availability (NOA) for 
the draft supplemental environmental impact statement was published in 
the Federal Register. This document provides an analysis of 
alternatives under consideration in Amendment 13. This document also 
contains a preliminary regulatory economic evaluation of the 
alternatives. The comment period on this document closes on October 15, 
2003. The public will also be provided with an opportunity to provide 
comments during formal Secretarial review of Amendment 13. An NOA for 
the Amendment and the proposed rule will be published in the Federal 
Register with comment periods specific to each. The Secretary will 
approve, disapprove, or partially approve the Amendment within 30 days 
of the close of the comment period on the NOA. A final rule 
implementing any approved portions of the Amendment will be published 
in the Federal Register.


Anticipated Cost and Benefits:


The Magnuson-Stevens Act is designed to realize the full potential of 
the fishery resources over the long term for the benefit of the Nation 
and the fishing industry. The process of achieving this goal can, and 
does, have serious impacts on fishermen and dependent communities. NMFS 
and the Council are fully aware of potential impacts from proposed 
management measures and work to ensure not only the long-term 
sustainability of groundfish resources, but also the economic vitality 
of New England fishing communities. There are likely short-term costs 
to the New England fishing industry in order to obtain long-term 
benefits to all users of the groundfish resource.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           01/00/04
NPRM Comment Period End                                        02/00/04
Final Action                                                   04/00/04
Final Action Effective                                         05/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, State


Additional Information:


The National Marine Fisheries Service (NMFS) amends its regulations to 
implement provisions of Amendment 13 to the Northeast (NE) Multispecies 
Fishery Management Plan (FMP). The principal objectives of Amendment 13 
include measures to implement a formal rebuilding program for 
overfished stocks and to end overfishing on those stocks where it is 
occurring and to bring the FMP into full compliance with the Magnuson-
Stevens Fishery Conservation and

[[Page 72458]]

Management Act (Magnuson-Stevens Act). In addition, this rule 
implements provisions that respond to the requirements of the Court 
Orders in the lawsuits of Conservation Law Foundation et al. v. Donald 
Evans et al. (CLF v. Evans) and American Oceans Campaign, et al. v. 
William M. Daley, et al. (AOC v. Daley).


Agency Contact:
Patricia A. Kurkul
Regional Administrator, Northeast Region, NMFS
Department of Commerce
National Oceanic and Atmospheric Administration
One Blackburn Drive
Gloucester, MA 01930
Phone: 978 281-9200
RIN: 0648-AN17
BILLING CODE 3510-BW-S

[[Page 72459]]

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, 2003, 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 cost-benefit analysis and the decisionmaking 
process.
Cost-Benefit

[[Page 72460]]

 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 worldwide 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 2002-D026, Procurements 
for Defense Against or Recovery From Terrorism or Nuclear, Biological, 
Chemical, or Radiological Attack, implements sections 852 through 856 
of the Homeland Security Act of 2002. Sections 852 through 856 provide 
new authorities for acquisitions by or for an executive agency of 
property or services that are to be used to facilitate defense against 
or recovery from terrorism or nuclear, biological, chemical, or 
radiological attack. An interim rule was published in the Federal 
Register on January 27, 2003, as part of Federal Acquisition Circular 
(FAC 2001-012) (68 FR 4048).
 DFARS Case 2002-D042, Contractor Performance of Security-Guard 
Functions, implements section 332 of the National Defense Authorization 
Act of Fiscal Year 2003. Section 332 provides temporary authority for 
contractor performance of security-guard functions to meet increased 
requirement since September 11, 2001.

[[Page 72461]]

An interim rule was published in the Federal Register on February 14, 
2003 (68 FR 7443).
Suggestions From the Public for Reform'Status of DoD Items
 In the report entitled ``Stimulating Smarter Regulation: 2002 Report 
to Congress on the Costs and Benefits of Regulations and Unfunded 
Mandates on State, Local, and Tribal Entities,'' there were two 
regulations and two guidance documents from the Army Corps of Engineers 
(Corps) that were nominated for reform.
 Two commenters suggested that the Corps' nationwide permit program 
should be modified. One of these commenters stated that the nationwide 
permits make it easier to dredge and fill wetlands. This commenter also 
expressed concern that recently issued guidance on mitigation places 
too much discretion in the hands of local Corps personnel to determine 
mitigation requirements for activities authorized by Corps permits. 
This commenter said that the nationwide permits should be made more 
restrictive to ensure that they authorize only activities with minimal 
impacts. In contrast, the other commenter stated that the acreage 
limits for nationwide permits are too low, and require more project 
proponents to obtain individual permits, which results in construction 
delays. This commenter indicated that the acreage limits for the 
nationwide permits should be reevaluated and the nationwide permit 
program should be modified to minimize paperwork and prevent 
unnecessary delays at all levels of government.
 The latest issuance of the nationwide permits was published in the 
January 15, 2002, issue of the Federal Register (67 FR 2020), and those 
nationwide permits expire on March 18, 2007. The nationwide permits are 
not classified as regulations. They are permits that authorize certain 
minor activities in waters of the United States that result in minimal 
adverse effects on the aquatic environment, individually and 
cumulatively. Although the nationwide permits are not regulations, the 
Corps coordinated the issuance 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 nationwide 
permits that were published on January 15, 2002, reflect the result of 
this interagency coordination.
 The acreage limits for nationwide permits are established so that 
those permits can be used to authorize most activities that have 
minimal adverse effects on the environment. Every 5 years, the terms 
and conditions of the nationwide permits are subject to a public notice 
and comment process, to ensure that the nationwide permits authorize 
only those activities with minimal individual and cumulative adverse 
environmental effects. Mitigation may be required to ensure that 
authorized activities result in minimal adverse environmental effects. 
Mitigation requirements are determined by local Corps personnel to 
account for regional differences in aquatic resources.
 One commenter recommended that the Corps and Environmental Protection 
Agency (EPA) revisit the revisions to the Clean Water Act regulatory 
definitions of ``fill material'' and ``discharge of fill material'' 
that were published on May 9, 2002 (67 FR 31129). This commenter said 
that an Environmental Impact Statement should be prepared to fully 
examine the implications of changing these regulatory definitions. This 
commenter also stated that a more thorough regulatory impact analysis 
should be conducted under E.O. 12866. The changes to the regulatory 
definitions of ``fill material'' and ``discharge of fill material'' 
that were published in the May 9, 2002, Federal Register resulted from 
the public notice and comment process required by the Administrative 
Procedures Act. The Corp does not agree that these changes require an 
Environmental Impact Statement, because the revised definitions will 
not significantly affect the quality of the human environment. The 
revised definitions provide consistency between the Corps' and EPA's 
regulations governing discharges of fill material into waters of the 
United States.
 One of the guidance documents recommended for reform is the joint 
guidance issued by the Corps and EPA on January 19, 2001, concerning 
the U.S. Supreme Court decision in the Solid Waste Agency of Northern 
Cook County vs. U.S. Army Corps of Engineers, 531 U.S. 159 (2001) 
(SWANCC). The commenter stated this joint guidance inappropriately 
limits the U.S. Supreme Court's ruling in that case. In the January 15, 
2003, issue of the Federal Register, the Corps and EPA issued an 
Advance Notice of Proposed Rulemaking (ANPRM) to obtain early comment 
on issues related to the scope of waters subject to Clean Water Act 
jurisdiction in light of the SWANCC decision by the U.S. Supreme Court. 
In appendix A of this ANPRM, there is a joint memorandum issued by the 
Corps and EPA that provides clarifying guidance regarding the U.S. 
Supreme Count's decision in SWANCC. This joint memorandum supercedes 
the January 19, 2001, guidance document cited by the commenter. The 
comments received in response to the ANPRM will be used to develop a 
proposed rule that addresses Clean Water Act jurisdiction in light of 
the SWANCC decision.
 Other guidance documents recommended for reform relate to wetland 
delineation, especially the 1987 ``Corps of Engineers Wetlands 
Delineation Manual'' (1987 Manual). The 1987 Manual contains the 
procedures the Corps uses for identifying the boundaries of wetlands. 
One commenter stated that rulemaking procedures should be applied to 
the 1987 Manual, as well as the criteria used to identify 
jurisdictional wetlands and other waters of the United States. Another 
commenter indicated that wetland regulation has impeded real estate 
development. The Corps has begun an effort to update and clarify the 
1987 Manual. This effort may also include the development of regional 
wetland delineation manuals. Any proposed changes to the 1987 Manual, 
or the issuance of regional wetland delineation manuals, will be 
subject to the public notice and comment procedures required by the 
Administrative Procedures Act.
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,'' addresses 
one significant regulatory action as defined by Executive Order 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.

[[Page 72462]]

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) 2004, the U.S. Army Corps of Engineers is 
proposing to complete 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, in 
conjunction with the Environmental Protection Agency (EPA), may propose 
a new regulation to provide additional clarification to the regulatory 
definition of ``waters of the United States'' for the purposes of the 
Clean Water Act.
 The U.S. Army Corps of Engineers was directed by Congress in section 
601 of the Water Resources Development Act of 2000 (Pub. L. 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. On July 10, 2003, the Acting Secretary of the 
Army submitted the final programmatic regulations to OMB for final 
Administration review. OMB will vet the final programmatic regulations 
with appropriate Federal agencies and hold several interagency meetings 
before clearing the final regulations for publication in Federal 
Register. The final programmatic regulations require the concurrence of 
the Governor of Florida and the Secretary of the Interior and 
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.
 The Department of the Army and the Environmental Protection Agency 
completed one Advance Notice of Proposed Rulemaking (ANPRM) in 2003. In 
a notice published in the January 15, 2003, issue of the Federal 
Register (68 FR 1991) the Army and EPA requested early comment on 
issues associated with the scope of waters that are subject to the 
Clean Water Act, in light of the U.S. Supreme Court decision in Solid 
Waste Agency of Northern Cook County v. U.S. Army Corps of Engineers, 
531 U.S. 159 (2001) (SWANCC). The ANPRM solicited information or data 
from the public, scientific community, and Federal and State resource 
agencies on the implications of the SWANCC decision on issues of 
regulatory jurisdiction under the Clean Water Act. In response to the 
ANPRM, approximately 150,000 comments were received. The Army and EPA 
are in the process of reviewing those comments to develop a Notice of 
Proposed Rulemaking that may be issued later this year.
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 (NHPA) 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. Forty-one comments were received in response to this notice. After 
completing its review of those comments, the Corps may propose, in 
fiscal year 2004, changes to 33 CFR part 325, appendix C, to bring the 
regulation into conformance with the new ACHP at 36 CFR part 800, or 
work with the ACHP to develop other Federal agency program 
alternatives, to comply with the requirements of the NHPA and other 
historic preservation laws.
Defense Procurement and Acquisition Policy
 Defense Procurement and Acquisition Policy launched a major 
transformation initiative to identify dramatic improvements and 
reductions to procurement policies, procedures, and processes in the 
Defense Federal Acquisition Regulation Supplement (DFARS). The focus of 
the DFARS will be clear requirements/procedures of law, mandatory DoD-
wide policy, deviations from the FAR, and delegations of authority. 
Procedures and guidance internal to DoD will be contained in a non-
regulatory second book that is electronically linked to the DFARS. This 
approach can foster an environment of flexibility and innovation, 
supporting a more rapid and responsive change process. The DFARS 
Transformation Task Force recommended more than 700 noncomplex changes 
and approximately 83 significant proposals, including proposed changes 
to the Federal Acquisition Regulation (FAR) and legislative changes. We 
have opened more than 75 new DFARS cases to implement the noncomplex 
proposals and the ``first wave'' of DFARS proposals. Some of these 
proposals include:
[sbull] Implement a proposal to mark all Government property in the 
            hands of a contractor with a unique item identifier and to 
            establish a value for such property.
[sbull] Eliminate application of the Balance of Payments Program to DoD 
            acquisition except as a reporting requirement.
[sbull] Standardize payment and billing instructions in the DFARS.
[sbull] Delete the requirement to conduct periodic risk assessments and 
            production surveillance of contractors that do not have 
            Government contracts with criticality designators A or B, 
            unless specifically requested by the Contracting Officer.
 In addition, the Department of Defense continuously reviews the FAR 
and continues to lead Government efforts to simplify the following 
acquisition processes:
[sbull] Consider FAR and DFARS changes to facilitate timely contract 
            closeout.

[[Page 72463]]

[sbull] Require contractors to submit electronic representations and 
            certifications via the Business Partner Network.
[sbull] Clarify labor standards for contracts involving construction.
[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] 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 policy on the applicability of cost accounting 
            standards. The goal of this initiative is to modify and 
            streamline the applicability of Federal cost accounting 
            standards.
[sbull] Revise the FAR part 45, Government Property, to organize and 
            streamline the property disposal procedures and 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, 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 in 2004.
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 be used to 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 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 was 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. The Department 
met with State and tribal representatives during preparation of the 
proposed rule published in August 2003. DoD plans to evaluate comments 
and publish a final rule in 2004.
_______________________________________________________________________
DOD--U.S. Army Corps of Engineers (COE)

                              -----------

                            FINAL RULE STAGE

                              -----------

33. 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, Final.


Abstract:


The U.S. Army Corps of Engineers was directed by Congress in section 
601 of the Water Resources Development Act of 2000 (Pub. L. 106-541, 
114 Stat.

[[Page 72464]]

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 
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                                                   12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Agency Contact:
Chip Smith
Assistant for Environmental, Tribal, and Regulatory Affairs
Department of Defense
U.S. Army Corps of Engineers
108 Army Pentagon 3E427
Washington, DC 20310-0108
Phone: 703 693-3655
Fax: 703 697-8433
Email: [email protected]
RIN: 0710-AA49
BILLING CODE 5001-08-S

[[Page 72465]]

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 757,500 people take advantage of these resources every week. 
We have forged effective partnerships with customers and others to 
develop policies, regulations, guidance, technical assistance, and 
approaches to compliance. We have a record of successful communication 
and shared policy development with affected persons and groups, 
including parents, students, educators, representatives of State and 
local governments, neighborhood groups, schools, colleges, special 
education and rehabilitation service providers, professional 
associations, advocacy organizations, business, and labor.
 In particular, we continue to seek greater and more useful customer 
participation in our rulemaking activities through the use of 
consensual rulemaking and new technology. If we determine that the 
development of regulations is absolutely necessary, we seek customer 
participation at all stages in advance of formal rulemaking, during 
rulemaking, and after rulemaking is completed in anticipation of 
further improvements through statutory or regulatory changes. We have 
expanded our outreach efforts through the use of satellite broadcasts, 
electronic bulletin boards, and teleconferencing. For example, we 
invite comments on all proposed regulations through the Internet.
 We are streamlining information collections, reducing burden on 
information providers involved in our programs, and making information 
maintained by us easily available to the public. We are looking into 
coordinating similar information collections across programs as one 
possible approach to reduce overlapping or inconsistent paperwork 
requirements. To the extent permitted by statute, we will 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.
 We have piloted two Internet-based software applications, e-
Application and e-Reports. These enable applicants, grantees, and grant 
teams to file and process applications and 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 excellence. One-ED is 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, and will provide 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. Implementing 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.
No Child Left Behind
 The No Child Left Behind Act of 2001, which reauthorized the 
Elementary and Secondary Education Act of 1965, increases 
accountability for States, school districts, and schools; provides 
greater choice for parents and students, particularly those attending 
low-performing schools; provides more flexibility for States and local 
educational agencies in the use of Federal education dollars; and 
places a stronger emphasis on reading, especially for our youngest 
children.
 Each State, Puerto Rico, and the District of Columbia has submitted an 
accountability plan, and each plan was approved by the Department'a 
major milestone achieved in record time. Educators and parents across 
the country have embraced the principles of this law and are working 
hard to implement it in their communities.
 The Department will now focus on helping States place a highly 
qualified teacher in every classroom; expanding the opportunities for 
qualified students to receive tutoring and other supplemental services; 
and identifying schools in need of improvement and making sure they are 
getting the assistance they need to get back on track.
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 72466]]

[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 Individuals with Disabilities Education Act 
(IDEA), parts C and D, will make changes considered to be needed to 
improve the implementation of the early intervention program for 
infants and toddlers with disabilities under part C and the 
effectiveness of national discretionary grants, contracts, and 
cooperation agreements in improving the education of children with 
disabilities 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.
_______________________________________________________________________
ED--Office of Special Education and Rehabilitative Services (OSERS)

                              -----------

                             PRERULE STAGE

                              -----------

34. REAUTHORIZATION OF THE INDIVIDUALS WITH DISABILITIES EDUCATION ACT
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. ED 
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

_______________________________________________________________________
Notice          67 FR 1411                                     01/10/02
ANPRM                                                          08/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


URL For Public Comments:
www.regulations.gov
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 72467]]

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
 The Department's ongoing rulemaking activities related to energy 
efficiency standards and determinations have been categorized as high, 
medium, or low priority. 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.
 During the coming year, the Department expects to revise the energy 
efficiency standards for residential furnaces, boilers, and mobile home 
furnaces; electric distribution transformers; commercial unitary air 
conditioners and heat pumps rated 65-240 kBtu/hr; and for small duct 
high velocity residential air conditioning. Additional information and 
timetables for these high priority actions can be found below. In 
addition, the Department will continue working on the analyses required 
to revise the standards for packaged terminal air conditioners and heat 
pumps, oil- and gas-fired commercial packaged boilers, 3-phased air 
conditioners and heat pumps rated less than 65 kBtu/hr, single package 
vertical air conditioners and heat pumps, and tankless gas-fired 
instantaneous water heaters.
 The Department plans to publish final rules concerning test procedures 
for clothes washers, 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 2003. In addition, the Department will be proposing in December 
2003, to add a new part, 10 CFR 851, Worker Safety and Health, that 
would establish basic requirements to ensure workers are protected from 
safety and health hazards at DOE facilities.
_______________________________________________________________________
DOE--Energy Efficiency and Renewable Energy (EE)

                              -----------

                             PRERULE STAGE

                              -----------

35. 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, Final.


Abstract:


The Energy Policy and Conservation Act (EPCA), as amended, establishes 
initial energy efficiency standard levels for most types of major 
residential appliances and generally requires DOE to undertake two 
subsequent rulemakings, at specified times, to determine whether the 
extant standard for a covered product should be amended.


This is the initial review of the statutory standards for furnaces, 
boilers and mobile home furnaces.


Statement of Need:


This rulemaking is required by statute. Experience has shown that the 
choice of residential appliances and commercial equipment being 
purchased by both builders and building owners is generally based on 
the initial cost rather than on life-cycle costs. Thus, the law 
requires minimum energy efficiency standards for appliances to 
eliminate inefficient appliances and equipment from the market.


Summary of Legal Basis:


EPCA establishes initial energy efficiency standard levels for most 
types of major residential appliances and certain commercial equipment. 
EPCA generally requires DOE to undertake rulemakings, at specified 
times, to determine whether the standard for a covered product should 
be made more stringent.

[[Page 72468]]

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 of 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 Btus of energy 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 upfront 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 and 
possible reductions in product utility. It might also 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                                                          02/00/04
NPRM                                                           01/00/05
Final Action                                                   09/00/05
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Local, State


Additional Information:


The Department published a notice in the Federal Register on July 8, 
2003, to announce that its statement in the semiannual regulatory 
agenda, 68 FR 30192, 30195 (May 27, 2003), to reclassify the activity 
on Energy Efficiency Standards for Residential Furnaces, Boilers, and 
Mobile Home Furnaces to a low priority was inadvertent and that the 
Department remains committed to involving stakeholders per the Process 
Rule. The Department is currently completing its economic analyses for 
potential new standards and expects to publish an ANPRM for public 
review and comment by February 2004. This action is a high priority, 
and the Department is working actively on this action.


Agency Contact:
Mohammed Kahn, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
U.S. Department of Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-7892
Email: [email protected]
RIN: 1904-AA78
_______________________________________________________________________
DOE--EE
36. 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 certain types of major 
residential appliances and certain types of commercial equipment. EPCA 
contains no energy efficiency standards for distribution transformers. 
This rulemaking will determine whether it is appropriate to establish 
such standards.


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 certain 
types of major residential appliances and certain types of commercial 
equipment and generally requires DOE to undertake rulemakings, at 
specified times, to establish the standards for those covered products 
without statutory standards.


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 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 Btus

[[Page 72469]]

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                                                          11/00/03
NPRM                                                           11/00/04
Final Action                                                   05/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Bryan Berringer, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
U.S. Department of Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0371
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AB08
_______________________________________________________________________
DOE--EE
37. 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 certain types of major 
residential appliances and certain types of commercial equipment. EPCA 
requires DOE to amend the standards for products whenever ASHRAE amends 
its standards.


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 certain 
types of major residential appliances and certain types of commercial 
equipment and requires DOE to amend the standard for this product when 
ASHRAE amends its standards, as recently occurred.


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                                                          11/00/03
NPRM                                                           11/00/04
Final Action                                                   05/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
James Raba
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
EE-2J
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-8654
Email: [email protected]
RIN: 1904-AB09
_______________________________________________________________________
DOE--Departmental and Others (ENDEP)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

38. WORKER SAFETY AND HEALTH
Priority:


Other Significant

[[Page 72470]]

Legal Authority:


42 USC 2011; 42 USC 5801 to 5911; 42 USC 7101 to 7352


CFR Citation:


10 CFR 851


Legal Deadline:


Final, Statutory, December 2, 2003, Final.


Abstract:


This action would add a new 10 CFR 851 regulation to DOE's regulations 
establishing a body of rules setting forth basic requirements to ensure 
workers are protected from safety and health hazards at DOE facilities.


Statement of Need:


The purpose of this rule is to ensure that the Department's obligation 
to protect the safety and health of its workers is fulfilled and to 
provide, if needed, a basis for the imposition of civil penalties 
consistent with section 3173 of the Bob Stump National Defense 
Authorization Act of 2003. This action is consistent with the 
Department's commitment to the issuance of safety and health 
requirements using notice and comment rulemaking.


Summary of Legal Basis:


Under the Atomic Energy Act of 1954 (AEA), as amended, the Department 
of Energy has the authority to regulate activities at facilities under 
its jurisdiction. On December 2, 2002, section 3173 of the National 
Defense Authorization Act amended the AEA to add section 234C (codified 
as 42 U.S.C. 2282c). Section 234C requires the Department to promulgate 
regulations for industrial and construction safety and health at DOE 
contractor facilities for contractors covered by an agreement of 
indemnification. The regulation must provide a level of protection to 
workers at such facilities that is substantially equivalent to the 
level of protection currently being provided to workers. Section 234C 
also makes DOE contractors that violate the safety and health 
regulations subject to civil penalties or a reduction of fees and other 
payments under its contract with DOE.


Alternatives:


None


Anticipated Cost and Benefits:


The incremental costs of the proposed rules should be minimal because 
contractors are currently bound by comparable contractual obligations.


Risks:


The proposed rule would allow DOE to assess penalties as directed by 
Congress for noncompliance. Therefore, contractors will be put at risk 
id they violate the safety and health requirements of the rule. The 
proposed rule may also reduce the injuries and illnesses of workers due 
to increased emphasis on complaint programs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 68276                                    12/08/03
NPRM Comment Period End                                        02/06/04
Final Action                                                   06/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
C. Rick Jones
Acting Deputy Assistant Secretary
Department of Energy
Office of Environment, Safety and Health
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 301 903-5926
RIN: 1901-AA99
_______________________________________________________________________
DOE--ENDEP

                              -----------

                            FINAL RULE STAGE

                              -----------

39. 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                                                   09/00/04
Regulatory Flexibility Analysis Required:


No

[[Page 72471]]

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 72472]]

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 especially affect some of the Nation's most vulnerable 
populations, including children, the elderly, and persons with 
disabilities. And, in one way or another, HHS activities touch the 
lives of virtually every person in our country, citizens and 
noncitizens alike.
 HHS's programs and activities include: Medicare, Medicaid, support for 
public health preparedness, 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 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 in a culture of responsiveness, 
where listening and responding to those we serve and those we regulate 
is our cornerstone. From health care to public health preparedness to 
food safety, the Secretary is committed to widening communication with 
consumers, beneficiaries and all regulated entities. Furthermore, the 
Secretary wishes to ensure that all HHS regulations are readily 
understandable, are clear and concise, and grounded both in law and 
common sense.
 Since the attacks of 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. In 
addition, consistent with the Secretary's priorities, the Department 
has taken important actions to enhance coordination of regulations 
across all its components.
FY 2004 Regulatory Themes
 The Secretary has adopted four overarching regulatory themes for FY 
2004:
[sbull] Improving the Nation's ability to prepare for and/or respond to 
            public health emergencies and disasters;
[sbull] Reducing medical errors and enhancing patient safety;
[sbull] Modernizing Medicare, especially through issuing regulations 
            emanating from Medicare-reform legislation, and
[sbull] Protecting America's consumers
 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 
Disasters
 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] Two final rules to improve readiness to respond to threats of 
            food-safety bioterrorism, by ordering the detention of 
            perishable food items, and by requiring the maintenance of 
            certain food-handling records;
[sbull] A proposed rule to define a key term in the food-safety 
            regulations so that FDA may move quickly and consistently 
            in responding to a threatened or actual attack on the U.S. 
            food supply;
[sbull] A proposed rule providing for an exception from the general 
            requirement for informed consent in the use of 
            investigational devices to identify chemical, biological, 
            radiological or nuclear agents in a potential terrorist 
            threat or other public health emergency; and
[sbull] A final rule for implementing a compensation program for 
            individuals adversely affected by smallpox immunizations.
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 final rule requiring human drug products to have a scanable 
            bar code that will reduce medication errors;
[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; and
[sbull] A final rule to enhance and make more timely the safety 
            reporting on drugs and biologics.
Modernizing Medicare
 Medicare provides health care coverage for 41 million Americans. The 
Secretary is working with the Congress on legislation that will provide 
new options for America's seniors under Medicare. The provisions of the 
Medicare-reform legislation were still under discussion at the deadline 
for submissions to The Regulatory Plan, but issuing the regulations 
required under the legislation will be among the Secretary's top 
priorities.
 The following regulatory actions, supported by already existing 
statutory authority, will also effect important improvements in 
Medicare:
[sbull] A final rule to expedite the Medicare coverage appeals;
[sbull] Two regulatory proposals to establish clearer performance 
            standards under Medicare for organ procurement 
            organizations, and a new mechanism for reapproval of organ 
            transplant centers; and
[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.
Protecting America's Consumers
 Consumer health and safety is a major concern for the public and the 
Secretary. Consumers are inundated

[[Page 72473]]

each year with an availability of new 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 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 final rule to standardize the manufacturing and packaging of 
            dietary supplements; and
[sbull] A proposed rule to strengthen safety requirements for the 
            storage and distribution of eggs.
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. Humphry Building, 200 Independence 
Avenue SW., Washington, DC 20201.
REGULATIONS BY THEME
1. Improving the Department's Ability to Respond to Emergencies and 
            Disasters:
[sbull] Smallpox Injury Compensation Program
[sbull] Definition of ``Serious Adverse Health Consequences'' under the 
            Public Health Security and Bioterroism Preparedness and 
            Response Act of 2002
[sbull] Establishment and Maintenance of Food Product Records
[sbull] Administrative Detention of Food for Human or Animal 
            Consumption
[sbull] Exception from General Requirements for Informed Consent
2. Reducing Medical Errors and Enhancing Patient Safety:
[sbull] Bar Code Label Requirements for Human Drug Products
[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
[sbull] Safety Reporting on Drugs and Biologics
3. Modernizing Medicare
[sbull] Revisions to the Medicare Appeals Process
[sbull] End Stage Renal Disease Conditions for Coverage
[sbull] Prospective Payment System for Psychiatric Hospitals
4. Protecting America's Consumers:
[sbull] Manufacturing and Packaging of Dietary Supplements;
[sbull] Review of National Medicare Coverage Determinations
[sbull] Control of Salmonella Enteriditis in Shell Eggs
_______________________________________________________________________
HHS--Office of the Secretary (OS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

40. [bull] HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT--
ENFORCEMENT
Priority:


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


Legal Authority:


Subtitle F of title II of PL 104-191; 42 USC 1320d-5


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This rulemaking would seek to establish a framework for enforcing 
compliance with the ``administrative simplification'' provisions of the 
Health Insurance Portability and Accountability Act (HIPAA) of 1996--
subtitle F of title II of Public Law 104-191 (42 U.S.C. 1320d-5).


Statement of Need:


The civil money penalty provisions of the above-cited statute provide, 
together with the criminal penalties authorized by 42 U.S.C. 1320d-6, 
the means by which the Federal Government may ensure compliance with 
the national standards adopted by the HHS Secretary under this statute. 
Regulation is needed to enable the Department to: 1) determine a basis 
for and amounts of civil money penalties that may be levied pursuant to 
the above-cited statute; and 2) establish procedures for the conduct of 
investigations and hearings with respect to the imposition of such 
penalties.


Summary of Legal Basis:


This regulation will implement provisions of 42 U.S.C. 1320d-5 and 42 
U.S.C. 1320a-7a relating to the imposition of civil money penalties by 
the Secretary for violations of the rules adopted by the Secretary 
pursuant to subtitle F.


Alternatives:


The proposed procedural provisions of the rule would generally follow 
the civil money penalty procedures adopted by the Department's Office 
of the Inspector General (OIG) with respect to the conduct of 
investigation and hearings regarding the imposition of civil money 
penalties in cases of fraud and abuse. These procedures are codified at 
45 C.F.R. parts 1003, 1005, and 1006. While the Department considered 
adopting different procedures, it decided not to do this for several 
reasons: the statutory language in section 1320d-5 specifically 
referring to the procedures adopted under section 1320a-7a (i.e., the 
OIG rules); the extensive experience of industry with the OIG rules; 
and the general agreement within the Department that the OIG rules 
provide workable procedures.


Anticipated Cost and Benefits:


The costs of this rule will consist primarily of the costs incurred by 
both the Department and any covered entities that are attributable to 
the investigation and hearing processes. These costs are expected to be 
minimal. Costs associated with compliance by entities subject to the 
HIPAA Administrative Simplification standards are not attributable to 
this rule.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/04
Regulatory Flexibility Analysis Required:


No

[[Page 72474]]

Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Carol Conrad
Department of Health and Human Services
Room 5347
Office of the General Counsel
330 Independence Avenue SW.
Washington, DC 20201
Phone: 202 690-1840
RIN: 0991-AB29
_______________________________________________________________________
HHS--Substance Abuse and Mental Health Services Administration (SAMHSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

41. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN 
CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH
Priority:


Other Significant


Legal Authority:


PL 106-310


CFR Citation:


Not Yet Determined


Legal Deadline:


NPRM, Statutory, April 2001, NPRM.


Abstract:


The Secretary is required by statute to publish regulations governing 
States that license nonmedical, community-based residential facilities 
for children and youth. The regulation requires States to develop 
licensing rules and monitoring requirements concerning behavior 
management practice that will ensure compliance; requires States to 
develop and implement such licensing rules and implementation 
requirements within one year; and ensures that States require such 
facilities to have adequate staff, and that the States provide training 
for professional staff.


Statement of Need:


In recent years, media, Government, and consumer reports of deaths and 
injuries occurring due to the use of seclusion and restraints have 
heightened concern about these mechanisms as interventions. The 
appropriate use of seclusion and restraint has been debated and 
regulated in various health care settings for many years. Researchers 
have examined the use of seclusion and restraint related injuries and 
deaths, and potential alternatives to address safety and care concerns 
while posing less inherent risk to the individual. Patient advocates, 
States and others have lobbied for reduced and more highly regulated 
use. States, health care facilities and professionals have examined 
mechanisms for reduction, and some have implemented training programs 
addressing alternatives as well as to promote applications that will 
minimize patient risk.


Summary of Legal Basis:


Sections 595 through 595B of the Public Health Service (PHS) Act (42 
U.S.C. 290jj-290jj-2) as amended by the Children's Health (CHA) Act of 
2000 (Pub. L. 106-310), section 3207, part I.


Alternatives:


No other regulatory alternatives were considered. The CHA requires the 
Secretary to promulgate regulations after consultation with appropriate 
State, local, public and private protection and advocacy organizations, 
health care professionals, social workers, facilities, and patients. 
Current regulations do exist, in some form, for hospitals and 
residential treatment facilities, while nursing homes and ICFs/MR use 
survey guidelines. The statutory language required that regulations be 
promulgated within one year of its enactment. This proposed rule is 
currently two years behind its mandated time of publication.


Anticipated Cost and Benefits:


The anticipated benefits include enhanced patient safety and better 
consumer protections. Increases in staff education and training are 
expected to lead to treatment alternatives and decreases in the use of 
seclusion and restraint as a means of intervention, which then leads to 
less traumatic experiences for both consumers and staff. The regulation 
creates a change in facility practices and policies on the use of 
seclusion and restraint. The regulation will create standard criteria 
for nonmedical community-based facilities for children and youth who 
receive PHS Act funds that will establish an industrywide effect on 
consumers who are receiving services within these facilities. The 
regulation creates consistent criteria for staff training and 
certification, facility staffing, and defining and reporting on 
seclusion and restraint.


The anticipated cost is based on regulations that will place 
requirements on all States as well as a projected estimate of 500 
facilities. At this time, the extent of potential facilities is 
unattainable until the notice of proposed rulemaking is issued. It is 
estimated that the cost will be $7 million a year. The proposed rule 
will specifically solicit comments on actual staff training and 
reporting costs, and it is assumed this cost will decrease since a 
number of States and/or facilities have existing training and reporting 
requirements.


Risks:


The risk in implementing the regulation--


1. Increase in cost for States and facilities in staff training, 
however, most facilities that currently use seclusion and restraint 
have some general staff training requirements. The CHA will only expand 
the content of this training.


2. Increase possibility of States having their PHS funding status in 
jeopardy due to noncompliance with regulations. States and industry may 
raise concern that the CHA's enforcement aspect is too harsh.


3. Confusion regarding what facilities are covered or not by the 
regulations as well as different standards for similar facilities based 
if they are or are not recipients of PHS Act funding.


The risk in not implementing the regulation--


1. Continued unregulated seclusion and restraint in certain Federally 
funded facilities.


2. Continued incidence as well as under reporting of deaths as a result 
of seclusion and restraint, or deaths that occur within 24 hours after 
an individual has been secluded or restrained, or where it is 
reasonable to assume that the individual's death was caused by being 
placed in seclusion or restraints.


3. Barrage of continued concerns from advocacy groups, the media and 
the Congress to publish this regulation, as well as requests from 
facilities for guidance.


4. Lack of protection for special needs populations, such as children, 
adolescents, persons with mental illness, developmental disabilities, 
or co-occurring mental retardation who are disproportionately affected 
by the

[[Page 72475]]

usage of seclusion or restraints as a common form of intervention.


5. Lack of direction to organizations, advocacy groups, and more than 
500 facilities for common definitions, industry language, and minimum 
criteria on staff training.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


State


Federalism:


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


Agency Contact:
Paolo Del Vecchio
Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
Phone: 301 443-2619
RIN: 0930-AA10
_______________________________________________________________________
HHS--Food and Drug Administration (FDA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

42. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS
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:


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 a 
plan that is designed to prevent transovarian SE from contaminating 
eggs at the farm during production.


FDA intends to discuss 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 consider whether it should require provisions 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. 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.


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 prevention measures; (4) alternative retail 
requirements; and (5) HACCP.


Anticipated Cost and Benefits:


The benefits from the proposed regulation to control Salmonella 
Enteritidis in shell eggs on the farm derive from better farming 
practices. 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 considered include on-farm rodent control, 
changes in retail food preparation practices, diversion of eggs from 
infected flocks to pasteurization, 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

[[Page 72476]]

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 that would include SE prevention measures, 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                                                           06/00/04
Regulatory Flexibility Analysis Required:


Yes


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]
RIN: 0910-AC14
_______________________________________________________________________
HHS--FDA
43. 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 an amendment to the exception from the general 
requirement for informed consent in certain circumstances involving the 
use of investigational in vitro diagnostic devices to identify 
chemical, biological, radiological, or nuclear agents in a potential 
terrorist event or other public health emergency.


Statement of Need:


The agency is proposing this action because it is concerned that, 
during a potential terrorism event or other public health emergency, 
delaying testing of specimens to obtain informed consent may threaten 
the life of the subjects or others who have been exposed to or who may 
be at risk of exposure to a chemical, biological, radiological, or 
nuclear agent.


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 the requirement of obtaining informed consent in life-
threatening situations such as those considered here. Section 
520(g)(3)(D) of the Act provides specifically for an exception from 
informed consent for investigational devices, subject to such 
conditions as the agency may prescribe. That section 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 the 
investigational 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 in writing with this 
three-part determination before the product is used 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. 
The investigator must submit the required documentation to the IRB 
within 5 days after the use of the device.


Alternatives:


The other option available to the agency is to work within the existing 
regulatory scheme. FDA believes that this option may result in delayed, 
improper or no diagnosis, and delayed, improper or no treatment for 
persons exposed to these agents because health professionals may not 
use these investigational products in a timely way or may not use them 
at all because of their inability to obtain informed consent.


Anticipated Cost and Benefits:


The minimal burdens imposed by this rule are offset by the fact that, 
in the absence of this rule, the investigator may be required to obtain 
informed consent, which is just as burdensome, if not more so. The rule 
would permit use 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 or other public 
health emergency. 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 including receiving delayed 
treatment, 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                                                           06/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Catherine Lorraine
Director, Policy Development and Coordination Group
Department of Health and Human Services
Food and Drug Administration
14-101-11
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-3360
Fax: 301 827-6777
RIN: 0910-AC25

[[Page 72477]]

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


Other Significant


Legal Authority:


21 USC 355b


CFR Citation:


21 CFR 201; 21 CFR 208; 21 CFR 209


Legal Deadline:


Final, Statutory, January 4, 2003, Final.


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 
a final rule to issue within one year of the date of its enactment on 
January 4, 2002.


Alternatives:


This 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

_______________________________________________________________________
NPRM                                                           03/00/04
Regulatory Flexibility Analysis Required:


Yes


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--FDA
45. [bull] DEFINITION OF ``SERIOUS ADVERSE HEALTH CONSEQUENCES'' UNDER 
THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE 
ACT OF 2002
Priority:


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


Legal Authority:


21 USC 334(h)(1)(A); 21 USC 335a(b)(3); 21 USC 343(v); 21 USC 350c(a) 
and (b); 21 USC 371; 21 USC 374(a)(1); 21 USC 381(j)(1) and 
(m)(2)(B)(ii); 21 USC 398(a)


CFR Citation:


21 CFR 1.3(c)


Legal Deadline:


None


Abstract:


The proposed rule would define the term ``serious adverse health 
consequences'' for purposes of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism 
Act) and any implementing regulations and guidance. The term is used to 
describe the standard that is the basis for FDA to exercise certain 
authorities provided in sections 303, 304, 306, 307, 308, and 310 of 
title III (Protecting Safety and Security of the Food and Drug Supply), 
subtitle A (Protection of Food Supply), of the Bioterrorism Act.


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), which was signed into law on June 12, 
2002. The Bioterrorism Act contains the term ``serious adverse health 
consequences'' to describe the standard relating to exercising many of 
the new authorities provided therein. Together with the final rules 
implementing sections 303, 306, and 307 of the Bioterrorism Act, and 
the other sections of the Bioterrorism Act incorporating the ``serious 
adverse health consequences'' term, a definition of the term will 
further enable FDA to act quickly and consistently in responding to a 
threatened or actual terrorist attack on the U.S. food supply or to 
other food-related, public health emergencies. A definition of the 
``serious adverse health consequences'' term will promote uniformity 
and consistency across FDA in understanding of the term and determining 
an appropriate response. In addition, a definition of the term will 
inform the public and stakeholders about what FDA considers to be a 
serious adverse health consequence under the Bioterrorism Act.


Summary of Legal Basis:


FDA is relying on section 701 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371) in issuing this proposed rule. FDA is also relying 
on the following sections of the Bioterrorism Act which the term 
``serious adverse health consequences'' appears: Section 303(a) (21 
U.S.C. 334(h)(1)(A)), Section 303(c) (21 U.S.C. 381(j)(1)), Section 
304(a)(2)(C) (21 U.S.C. 335a(b)(3)), Section 306(a) (21 U.S.C. 350c(a) 
and (b)), Section 306(b) (21 U.S.C. 374(a)(1)), Section 307(a) (21 
U.S.C. 381(m)(2)(B)(ii)), Section 308(b) (21 U.S.C. 343(v)), and 
Section 310 (21 U.S.C. 398(a)).


Alternatives:


In the interests of quickly providing the agency's interpretation of 
``serious adverse health consequences'' to the public, FDA considered 
explaining the term in guidance. The agency concluded, however, that 
this option is neither effective nor efficient because guidance does 
not have the force and effect of law. If the definition or its 
application is ever challenged, guidance will receive less deference

[[Page 72478]]

than if the definition were in a regulation.


FDA also considered explaining the term in guidance followed by a 
regulation at a later date. This option was considered because it 
offers the advantage of rapidly informing the public about the agency's 
position while the agency gathers more information and experience in 
applying the definition. The agency concluded that guidance followed by 
a regulation was undesirable. First, as to the initial guidance, FDA 
would meet the same problems described above for the ``guidance only'' 
option. Second, this option creates a burdensome process for FDA by 
doubling the agency's responsibilities--first, to publish guidance, and 
second, to engage in notice and comment rulemaking. FDA resources will 
be conserved by avoiding this two-step process. Further, there is the 
possibility that once guidance publishes, a regulation might not 
follow. As a result, the definition might never have the force and 
effect of law.


FDA also considered defining or explaining ``serious adverse health 
consequences'' in preambles to rules promulgated under the Bioterrorism 
Act. However, implementing regulations are not required for all 
sections of the Bioterrorism Act that incorporate the term. Thus, the 
term would not be publicly addressed in the context of all of the 
applicable sections of the Bioterrorism Act. Second, because preambles 
are not codified and incorporated into the Code of Federal Regulations, 
the context and interpretation of the term eventually may become 
disassociated from the codified regulations. Finally, the rule ing of 
the Bioterrorism Act had already been published or were going to be 
published soon when this option was considered. Thus, there was 
insufficient time to include this discussion in the preambles to the 
current proposed rules for these sections.


FDA also considered adopting one of the two similar definitions for 
``serious adverse health consequences'' or the definition for ``serious 
injury'' in the medical devices regulations to promote consistency 
within the agency and avoid confusion. (In the medical devices 
reporting regulations, the preamble to the final rule states that ``the 
agency intends for 'serious adverse health consequences' to have the 
same meaning as 'serious injury' under the [Medical Device Reporting] 
rule.'') This option could promote greater consistency within the 
agency, avoid confusion, and also save time. However, the agency 
believes that a broader definition must be used for foods and feeds in 
order to satisfy Congressional intent. Specifically, it must be clear 
that the definition of ``serious adverse health consequences,'' for 
purposes of the Bioterrorism Act, (1) expressly includes vulnerable 
populations, and (2) expressly apply to food for humans and animals. In 
addition, there are terms incorporating the concept of ``serious'' in 
CDER and CDRH regulations. The definitions of these terms are not 
entirely consistent because they are tailored to the needs of each 
Center and apply only to specific portions of the applicable 
regulations, i.e., they have specific uses and contexts. Thus, a 
specific definition for ``serious adverse health consequences'' under 
the Bioterrorism Act is necessary in order to avoid confusion among 
differing definitions of ``serious,'' ``serious injury,'' or ``serious 
adverse health consequences'' in other regulations, and the context in 
which these terms are defined and applied. The proposed definition 
would apply to: (1) all foods and feeds in bioterrorist events and 
other public health emergencies; and (2) all populations, vulnerable or 
healthy, effectively having very wide applicability in a wide variety 
of emergency situations. Finally, FDA considered leaving the term 
undefined, thereby providing maximum flexibility for determining what 
constitutes ``serious adverse health consequences'' on a case-by-case 
basis. By not defining, the agency could avoid the potential 
consequences of a definition that is either too broad or too narrow. 
However, leaving the term undefined could cause confusion and 
inconsistency in implementation. Moreover, if an agency action under 
the Act is challenged, an undefined term will be left to a court's 
interpretation. A court, however, is not the most appropriate or expert 
body to decide the meaning of ``serious adverse health consequences.''


Anticipated Cost and Benefits:


The impact of this proposed rule will depend on how FDA decides to 
define the term ``serious adverse health consequences,'' which is used 
as a standard for taking action under the administrative detention, 
record keeping, and prior notice provisions of the Bioterrorism Act. 
The broader the definition, the greater the cost and benefits 
associated with it. For example, if ``serious adverse health 
consequences'' were defined to include any case of foodborne illness, 
then foods would be administratively detained more often than if the 
definition were limited to cases resulting in death. A broader 
definition will mean the term is used more frequently in conjunction 
with the provisions of the Bioterrorism Act; and therefore, there will 
be more costs, but there will also be more benefits.


Risks:


Regulations implementing legislation to protect the health of citizens 
against bioterrorism and other public health emergencies 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. This proposed rule would support 
those regulations by defining a key term contained therein, thereby 
improving FDA's ability to act quickly and consistently in responding 
to a threatened or actual terrorist attack on the U.S. food supply or 
to other food-related, public health emergencies.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 72479]]

Agency Contact:
Ms. Karen Carson
Deputy Director, Office of Plant and Dairy Foods and Beverages
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway, Rm 3 A-001
College Park, MD 20740
Phone: 301 436-1664
Fax: 301 436-2632
Email: [email protected]

John E. Kvenberg
Deputy Director, Office of Compliance (HFS-600)
Department of Health and Human Services
Food and Drug Administration
HFS-10
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway, Rm 3B064
College Park, MD 20740
Phone: 301 436-2359
Fax: 301 436-2717
Email: [email protected]
RIN: 0910-AF06
_______________________________________________________________________
HHS--FDA
46. [bull] USE OF OZONE-DEPLETING SUBSTANCES: REMOVAL OF ESSENTIAL USE 
DESIGNATION; ALBUTEROL
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


15 USC 402; 15 USC 409; 21 USC 321; 21 USC 331; 21 USC 335; 21 USC 342; 
21 USC 343; 21 USC 346a; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 
355; 21 USC 360b; 21 USC 361; 21 USC 362; 21 USC 371; 21 USC 372; 21 
USC 374; 42 USC 7671 et seq


CFR Citation:


21 CFR 2.125


Legal Deadline:


None


Abstract:


Under the Clean Air Act, the Food and Drug Administration (FDA) within 
the U.S. Department of Health and Human Services, in consultation with 
the Environmental Protection Agency, is required to determine whether 
an FDA-regulated product that releases an ozone-depleting substance 
(ODS) is essential. The two agencies have tentatively determined that 
the two currently marketed non-ODS metered-dose inhalers (MDIs) will be 
satisfactory alternatives to albuterol MDIs that contain ODS, and are 
proposing to remove the essential use designations for albuterol MDIs. 
If the essential use designation is removed, albuterol MDIs that 
contain an ODS could not be marketed after a suitable transition 
period. The proposed rule will specifically ask for comments on which 
phase-out period length will best ensure a smooth transition and 
minimize any adverse affects on the public health.


Statement of Need:


Chlorofluorocarbons (CFCs) are organic compounds that contain carbon, 
chlorine, and fluorine atoms. CFCs were first used commercially in the 
early 1930's and were later found to be useful as propellants in self-
pressurized aerosol products, such as MDIs. CFCs are very stable in the 
troposphere--the lowest part of the atmosphere. They move to the 
stratosphere, a region that begins about 10-16 kilometers (km) (6-10 
miles) above Earth's surface and extends up to about 50 km (31 miles) 
altitude. Within the stratosphere there is a zone about 15 to 40 km 
(10-25 miles) above the Earth's surfaces in which ozone is relatively 
highly concentrated. The zone in the stratosphere is generally called 
the ozone layer. Once in the stratosphere, CFCs are broken down by 
strong ultraviolet light, where they release chlorine atoms that then 
deplete stratospheric ozone. Depletion of stratospheric ozone by CFCs 
and other ODS will lead to higher UVB levels, which in turn will cause 
increased skin cancers and cataracts and potential damage to some 
marine organisms, plants, and plastics.


The link between CFCs and the depletion of stratospheric ozone was 
discovered in the mid-1970's. Since 1978, the U.S. government has 
pursued a consistent policy of limiting the production and use of ODS, 
including CFCs.


Summary of Legal Basis:


The Clean Air Act and EPA's implementing regulations contain general 
prohibitions on the use and manufacture of ODS, such as CFCs. 
Exceptions to these bans are provided for specific medical products 
that FDA, in consultation with EPA, has found to be essential. FDA's 
essential use determinations have been contained in 21 C.F.R. section 
2.125.


FDA published a new 21 C.F.R. section 2.125 in the Federal Register on 
July 24, 2002 (67 FR 48370), (corrected in the Federal Registers of 
July 30, 2002 (67 FR 49396) and September 17, 2002 (67 FR 58678)). 
Section 2.125 provides criteria for determining when a use is essential 
and when a use is no longer essential. The procedures to determine when 
a use is no longer essential were implemented to better carry out 
responsibilities under both the Clean Air Act and the Montreal Protocol 
on Substances that Deplete the Ozone Layer, (September 16, 1987, S. 
Treaty Doc. No. 10, 100th Cong., 1st sess., 26 I. L. M. 1541 (1987)).


Fran Du Melle, Executive Vice President of the American Lung 
Association, submitted a citizen petition on behalf of the U.S. 
Stakeholders Group on MDI Transition on January 29, 2003 (Docket No. 
03P-0029/CP1). The petition requested that FDA initiate rulemaking to 
remove the essential use of albuterol MDIs. After evaluating the 
petition, comments submitted in response to the petition, and other 
information, FDA has tentatively determined that albuterol MDIs meet 
the criteria in section 2.125 for removal of an essential use.


Alternatives:


In the proposed rule, FDA will specifically request comments on the 
best effective date for any final rule to remove the essential use 
status of albuterol. FDA will consider which dates will allow 
manufacturers to obtain the capacity to produce adequate numbers of 
non-ODS albuterol MDIs. FDA will also consider which dates might 
minimize any financial burden on patients who would have to switch to 
non-ODS albuterol MDIs.


Anticipated Cost and Benefits:


The expected benefit from this rulemaking, as part of an overall policy 
to eliminate production and use of ODSs, is the preservation of the 
Earth's stratospheric ozone.


Currently there are generic versions of ODS albuterol MDIs, while there 
are no generic non-ODS albuterol MDIs. This rulemaking could force 
patients to switch from lower-priced generic versions of ODS albuterol 
MDIs to higher-priced non-ODS albuterol MDIs.

[[Page 72480]]

Risks:


FDA is concerned about the possibility that some patients might stop 
using needed drugs because the prices of non-ODS albuterol MDIs might 
be higher than those of ODS albuterol MDIs.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/04
NPRM Comment Period End                                        06/00/04
Final Action                                                   03/00/05
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Wayne H. Mitchell
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
1451 Rockville Pike
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AF18
_______________________________________________________________________
HHS--FDA

                              -----------

                            FINAL RULE STAGE

                              -----------

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


Other Significant. Major status under 5 USC 801 is 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 C.F.R. 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.


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 C.F.R. 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

[[Page 72481]]

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
NPRM Comment Period Reopening End                              06/22/01
Final Action                                                   04/00/04
Regulatory Flexibility Analysis Required:


Yes


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
48. 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 C.F.R. 
312.32 for sponsors of investigational drugs for human use. FDA also 
has safety reporting requirements in sections 21 C.F.R. 310.305, 
314.80, 314.98 and 600.80 and 600.81 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

[[Page 72482]]

(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            68 FR 12406                                    03/14/03
NPRM Comment Period Extended                                   06/18/03
NPRM Comment Period End                                        07/14/03
NPRM Comment Period Extension End                              10/14/03
Comment Review End                                             09/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Undetermined


Agency Contact:
Audrey Thomas
Regulatory Policy Analyst, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
1451 Rockville Pike
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA97
_______________________________________________________________________
HHS--FDA
49. CGMP FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES AND 
TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK OF TRANSMITTING HCV INFECTION (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 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 FDA's comprehensive review of the biologics 
regulations and on reports by the U.S. House of Representatives 
Committee on Government Reform and Oversight's, Subcommittee on House 
Resources and Intergovernmental Relations, the General Accounting 
Office, and the Institute of Medicine, as well as on 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 (these activities are often called ``lookback''). FDA believes that 
regulations should be established consistent with the previous 
recommendations, to assure that 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 (42 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. This rulemaking 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. These regulations 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.

[[Page 72483]]

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 that these costs will be more than 
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 that 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                                                   11/00/04
Regulatory Flexibility Analysis Required:


No


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: 301 827-9434
RIN: 0910-AB76
_______________________________________________________________________
HHS--FDA
50. 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 proposed in the Federal Register of 
March 13, 2003 (68 FR 12158), current good manufacturing practice 
(CGMP) regulations for dietary ingredients and dietary supplements. The 
proposed rule was published to establish the minimum CGMPs necessary to 
ensure that, if firms engage in activities related to manufacturing, 
packaging, or holding dietary ingredients of dietary supplements, they 
do so in a manner that will not adulterate and misbrand such dietary 
ingredients or dietary supplements. FDA also proposed to require 
manufacturers to evaluate the identity, purity, quality, strength, and 
composition of their dietary ingredients and dietary supplements. The 
proposed rule 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 FDA.


Statement of Need:


FDA intends to publish a 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 CGMPs 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 CGMPs are end product 
testing and Hazard Analysis Critical Control Points (HACCP). The agency 
asked 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.


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,

[[Page 72484]]

affecting whole segments of the population, causing some severe long-
term effects and even loss of life. Dietary supplements are used by a 
large segment of the American public. Moreover, they are often used by 
segments of the population that are particularly vulnerable to 
adulterated products, such as the elderly, young children, pregnant and 
nursing women, and persons who may have serious illnesses or are taking 
medications that may adversely interact with dietary supplements. FDA 
has adopted or proposed manufacturing controls for a number of foods 
and commodities that present potential health hazards to consumers if 
not processed properly, including seafood, juice products, and fruits 
and vegetables, and it is appropriate that FDA consider whether 
manufacturing controls are necessary to assure consumers that dietary 
supplements are not adulterated during the manufacturing, packing, or 
holding process.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           62 FR 5700                                     02/06/97
ANPRM Comment Period End                                       06/06/97
NPRM            68 FR 12157                                    03/13/03
NPRM Comment Period End                                        08/11/03
Comment Review End                                             01/00/04
Regulatory Flexibility Analysis Required:


Yes


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: 301 436-2370
Fax: 301 436-2636
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________
HHS--FDA
51. BAR CODE LABEL REQUIREMENTS FOR HUMAN DRUG PRODUCTS AND BLOOD
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 final rule would require human drug products 
and biological products to have a bar code. The bar code would contain 
certain information about the product, and when used in conjunction 
with bar code scanners and computer equipment, would help reduce the 
number of medication errors. The final rule would also require the use 
of machine-readable information on blood and blood component container 
labels.


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 many 
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.


FDA proposed to require certain drug products to be bar coded. The bar 
code would contain certain information about the product, such as its 
National Drug Code number. The bar code, when used in conjunction with 
bar code scanners and computer equipment, will enable health 
professionals to decrease the medication error rate.


For blood and blood components intended for transfusion, FDA proposed 
to require the use of machine-readable informatin in a format approved 
by the Director of the Center for Biologics Evaluation and Research.


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). 502(a) of the Act 
prohibits the false or misleading labeling of drugs. 502(f) of the Act 
requires drug labeling to have adequate directions for use, adequate 
warnings against use by patients where its use may be dangerous to 
health, as well as adequate warnings against unsafe dosage or methods 
or duration of

[[Page 72485]]

administering in such a manner and form as necessary to protect uses.


Section 501(a)(1) of the Act considers a drug to be adulterated if, 
among other things, the methods used in, or the facilities and controls 
used for, its manufacture, processing, packing, or holding do not 
conform to or are not operated or administered in conformity with 
current good manufacturing practice to assure that the drug meets the 
requirements of the Act as to safety and ``has the identity and 
strength, and meets the quality and purity characteristics, which it 
purports or is represented to possess. . . .''


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


A bar code requirement for human drug products and biological products 
would be consistent with, and aid in the efficient enforcement of, 
sections 501 and 502 of the Act. For example, if the bar code merely 
contained the drug's National Drug Code number, the bar code would 
identify the manufacturer and the drug, and this would be consistent 
with sections 502(b) and 502(e)(1)(A) of the Act. If the bar code 
contained other information, such as lot number and expiration date 
(pieces of information required under FDA's good manufacturing practice 
regulations (see 21 C.F.R. 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 allowing the use of automatic identification 
technologies either in place or in addition to the bar code. However, 
use of incompatible or expensive technologies could deter hospitals and 
health care professionals from buying scanning or reading equipment.


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 approximately $78 million over a 20-year period.


The rule's principal benefit would be a reduction in the number of 
medication errors, including reduced mortality and morbidity. FDA's 
preliminary estimate is that the reduced mortality and morbidity will 
yield a benefit of $44.8 billion over a 20-year period.


Risks:


The proposed rule invited comment on whether the final rule should 
contain a general exemption provision. There is a risk that an 
exemption provision could result in many exemption requests which, if 
granted, could reduce the rule's effectiveness.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 12500                                    03/14/03
Final Rule                                                     01/00/04
Regulatory Flexibility Analysis Required:


Yes


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 and Planning
5600 Fishers Lane
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AC26
_______________________________________________________________________
HHS--FDA
52. ADMINISTRATIVE DETENTION OF FOOD FOR HUMAN OR ANIMAL CONSUMPTION 
UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND 
RESPONSE ACT OF 2002
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


21 USC 334; 21 USC 331; 21 USC 381; 21 USC 371


CFR Citation:


21 CFR 1; 21 CFR 10.45(d); 21 CFR 16.1(b)(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 of FDA has 
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 certain enforcement actions (i.e., seizures and 
injunctions) against perishable foods.


FDA intends to implement section 303 of the Act by issuing a regulation 
to provide for: 1) a detention procedure; 2) expedited procedures for 
enforcement actions with respect to perishable foods; 3) security 
procedures for detained foods including moving them to a secure 
facility, as appropriate; and 4) 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 (Pub. L. 107-188), 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) (21 U.S.C. 334(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 (21 U.S.C. 331) by

[[Page 72486]]

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.


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 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 opportunity for an 
informal hearing, to confirm or terminate a detention order within five 
days of an appeal. Section 201(x) of the FFDCA (21 U.S.C. 321(x), 
defines ``informal hearing'' and describes the requirements necessary 
for informal hearings. 21 C.F.R. part 16 outlines FDA's informal 
hearing procedures in greater detail. Part 16 allows minimum timeframes 
to request and hold an informal hearing, but provides no requirements 
or limitations on the length of the informal hearing. FDA is finalizing 
a rule tailored to the administrative detention provisions in the 
Bioterrorism Act which necessitates some modifications to the 
provisions in part 16. If FDA were to include the minor modifications 
in a guidance document, FDA would not be able to enforce the new 
provisions because guidance documents are not binding (21 C.F.R. 
10.115(d)). If FDA chose simply to follow part 16, the agency 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 required by the Bioterrorism Act.


Anticipated Cost and Benefits:


In the analysis of the proposed rule, we estimated that this rule would 
result in social costs of $0 to $38 million per year due to product 
transportation, storage, loss of product value during storage, marking 
or labeling, and the cost of appeals. We may need to revise these 
estimates after reviewing the comments we received on the proposed 
rule. Administrative detention would generate benefits because it 
improves our ability to respond to outbreaks from accidental and 
deliberate contamination of food, and to deter deliberate 
contamination. We have insufficient information to estimate benefits.


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            68 FR 25242                                    05/09/03
NPRM Comment Period End                                        07/08/03
Final Action                                                   03/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


None


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
53. ESTABLISHMENT AND MAINTENANCE OF RECORDS PURSUANT TO THE PUBLIC 
HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002
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:


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 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 (the Act), authorizes the Secretary, through 
FDA, to promulgate final regulations by December 12, 2003. The Act 
authorizes regulations that 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. 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. Section 306 of the Act also added section 414(a) and 
amended section 704(a) of FFDCA to permit FDA to inspect these records 
and other information if the Secretary has a reasonable belief that an 
article of food is adulterated and presents a threat of serious adverse 
health consequences or death to humans or animals.


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), which was signed into law on June 12, 
2002. The regulations will implement section 306 of the Bioterrorism 
Act.


Summary of Legal Basis:


Section 306 of the Bioterrorism Act amended the FFDCA by adding section 
414(b), which authorizes the Secretary to establish by regulation 
requirements for the creation and maintenance of records. That section 
of the Bioterrorism Act also added section 414(a) and amended section 
704(a) of the FFDCA to permit FDA to inspect records and other 
information under

[[Page 72487]]

certain circumstances. 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 required by the 
new regulations, or refusal to permit access to those records or other 
information as required by the new regulations, a prohibited act.


Alternatives:


None.


Anticipated Cost and Benefits:


The records provisions will be classified as significant under 
Executive Order 12866 (having an annual effect on the economy of over 
$100 million). The recordkeeping provisions would impose a substantial 
cost on industry. A first estimate is that the proposed provisions will 
cost the food industry approximately $235 million in the first year, 
approximately $510 million in the second year, and approximately $220 
million every year there after.


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 chain of custody of foods. While, 
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, FDA uses data collected by the 
agency on past outbreaks to estimate the benefit of the recordkeeping 
provisions on standard traceback investigations. Specifically we 
estimate the extent to which improved recordkeeping practices will 
facilitate faster traceback investigations.


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            68 FR 25188                                    05/09/03
NPRM Comment Period End                                        07/08/03
Final Action                                                   03/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


None


URL For More Information:
www.fda.gov/oc/bioterrorism/bioact.html
URL For Public Comments:
www.fda.gov/ohrms/dockets/02n0277/02n0277.htm
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--Health Resources and Services Administration (HRSA)

                              -----------

                            FINAL RULE STAGE

                              -----------

54. [bull] SMALLPOX VACCINE INJURY COMPENSATION PROGRAM: ADMINISTRATIVE 
IMPLEMENTATION
Priority:


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


Legal Authority:


PL 108-20, 117 Stat 638


CFR Citation:


42 CFR 102


Legal Deadline:


None


Abstract:


To provide benefits to certain persons harmed as a result of receiving 
smallpox covered countermeasures, including the smallpox vaccine, or as 
a result of contracting vaccinia through accidental exposure to certain 
persons. The Secretary may also provide death benefits to certain 
survivors of people who died as a direct result of these injuries.


Statement of Need:


This interim final rule will meet the need to set out the 
administrative policies, procedures, and requirements governing the 
Smallpox Vaccine Injury Compensation Program (the SVIC Program). Thus, 
the rule will describe the categories of eligible requesters under the 
SVIC Program (smallpox vaccine recipients, vaccinia contacts, survivors 
of deceased smallpox vaccine recipients or vaccinia contacts, and 
representatives of the estates of deceased smallpox vaccine recipients 
or vaccinia contacts), as well as the types of benefits available 
(medical benefits, benefits for lost employment income, and death 
benefits). It will also detail how requesters can submit medical 
documentation concerning eligibility, concerning whether their injuries 
are included among those listed in the Table of Injuries published in 
the Federal Register on August 27, 2003, and the time frames for the 
onset of those injuries, nontable injuries, and injuries from other 
covered countermeasures (e.g., cidofovir and vaccinia immune globulin). 
The rule will describe the filing deadlines and the documentation 
needed for the Secretary to make both eligibility and benefits 
determinations. In addition, the regulation will provide a detailed 
explanation as to how each type of benefit will be calculated, the 
limitations imposed on such benefits, and the method of payment.


Summary of Legal Basis:


The SVIC Program was authorized by the Smallpox Emergency Personnel 
Protection Act of 2003, Public Law 108-20, 117 Stat. 638.


Alternatives:


In order to implement the statute, the Department is clearly obligated 
to take the kinds of steps described above.


Anticipated Cost and Benefits:


The SVIC Program is designed to provide benefits to certain persons 
harmed as a direct result of receiving smallpox-covered 
countermeasures, including the smallpox vaccine, or as

[[Page 72488]]

a direct result of contracting vaccinia through certain accidental 
exposures. Minimal administrative costs are associated with this 
rulemaking.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Paul T. Clark
Director, Smallpox Vaccine Injury Compensation Program
Department of Health and Human Services
Health Resources and Services Administration
10th Floor HRSA/OSP
4350 East West Highway
Bethesda, MD 20814
Phone: 888 496-0338
Email: [email protected]
RIN: 0906-AA61
_______________________________________________________________________
HHS--Centers for Medicare & Medicaid Services (CMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

55. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (CMS-3818-P)
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; 
42 CFR 488; 42 CFR 489; 42 CFR 494; 42 CFR 413; 42 CFR 414


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 226 of the Act. 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 that do not reflect current medical 
practices or scientific advances in the field.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Yes


Government Levels Affected:


None


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
Phone: 410 786-6797

Teresa Casey
Health Insurance Specalist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-05-04
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-7215
RIN: 0938-AG82
_______________________________________________________________________
HHS--CMS
56. HOSPITAL CONDITIONS OF PARTICIPATION: REQUIREMENTS FOR APPROVAL AND 
REAPPROVAL OF TRANSPLANT CENTERS TO PERFORM ORGAN TRANSPLANTS (CMS-
3835-P)
Priority:


Other Significant


Legal Authority:


42 USC 1302; 42 USC 1395hh


CFR Citation:


42 CFR 482


Legal Deadline:


None


Abstract:


This proposed rule would establish conditions of participation for 
Medicare-covered transplants.


Statement of Need:


CMS' present criteria for heart, liver, and lung transplantation 
centers were developed at a time when the Department's policies were 
intended to promote long-term survival of transplanted organs through 
use of patient selection policies that avoided selection of high risk 
patients and use of unadjusted actuarial survival as a measure of 
outcome and experience. More than 64,000 Americans are waiting for 
organ transplants, yet only about 20,000 receive organs annually.

[[Page 72489]]

About 4,000 persons die each year waiting for an organ to become 
available. We consider of paramount importance our role in promoting 
awareness of the organ transplant situation, encouraging increased 
organ donation, fostering proper stewardship of this scarce national 
resource, and ensuring that Federal policies result in equitable 
distribution of organs. While the goal of promoting long-term survival 
is laudable, we have subsequently concluded that such criteria deter 
transplantation of high-risk patients, may not promote equitable 
distribution of organs, and may potentially increase deaths awaiting 
transplant.


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


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


Summary of Legal Basis:


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


Alternatives:


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


Anticipated Cost and Benefits:


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


CMS has not yet quantified the costs. Response to the proposed rule 
should help to determine the cost of there requirements.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None

[[Page 72490]]

Agency Contact:
Eva Fung
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-06-6
Office of Clinical Standards and Quality
S3-06-06
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-7539

Aucha Prachanronarong
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Office of Clinical Standards and Quality
S3-02-01
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-9614
RIN: 0938-AH17
_______________________________________________________________________
HHS--CMS
57. 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, Final.


Abstract:


This rule would establish conditions for coverage for organ procurement 
organizations (OPOs) to be certified by the Secretary to receive 
payment from Medicare and Medicaid for organ procurement costs, and to 
be designated by the Secretary for a specific geographic service area. 
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 recertification 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
NPRM                                                           05/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Jacqueline Morgan
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-02-01
Office of Clinical Standards and Quality
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4282
RIN: 0938-AK81
_______________________________________________________________________
HHS--CMS
58. 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.


Legal Authority:


PL 105-554, Children's Health Act of 2000


CFR Citation:


42 CFR 101; 42 CFR 418; 42 CFR 482; 42 CFR 483; 42 CFR 485; . . .


Legal Deadline:


None


Abstract:


This proposed rule would implement provisions of the Children's Health 
Act of 2000 (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. Concern 
about use is nothing new, however; 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

[[Page 72491]]

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. Reports of injuries and deaths, however, 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 
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. SAMHSA intends to publish a notice of proposed 
rulemaking to implement part I, which sets forth requirements related 
to the rights of residents of certain nonmedical, community-based 
facilities for children and youth. 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. Nevertheless, current 
regulations exist, in some form, for hospitals and residential 
treatment facilities, while nursing homes and ICFs/MR use 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 proposed rule is currently two years behind 
its mandated time of publication.


Anticipated Cost and Benefits:


The anticipated benefits include enhanced patient safety and better 
consumer protections. Increases in staff education and training are 
expected to lead to treatment alternatives and decreases in the use of 
restraint and seclusion as a means of intervention, which then leads to 
less traumatic experiences for both beneficiaries and staff. 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 patient 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 
32,350 Medicare and Medicaid funded facilities. At this time, however, 
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 $0.5 billion a year for Federal Medicaid, and $2.5 
to $3 billion for all payers. The proposed rule will specifically 
solicit comments on actual staff training and reporting costs, and it 
is assumed this cost will decrease since the majority of facilities 
currently have training and reporting requirements.


Risks:


The risk in implementing the regulation--


1. Increase in cost for facilities in staff training, however, 
facilities that currently use 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. Increase possibility of facilities having their Federal funding 
status placed in jeopardy due to noncompliance 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 the Congress and its OBRA '87 language to 
devise other alternative sanctions besides termination from the 
Medicare or Medicaid programs.


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, critical access hospitals, however 
nursing homes have requirements in their survey guidance materials).


The risk in not implementing the regulation--


1. Continued unregulated use of restraint and seclusion in certain 
Federally funded facilities.


2. Continued under reporting of deaths as a result of restraint or 
seclusion, or deaths that occur within 24 hours after an individual has 
been restrained or in seclusion, or where it is reasonable to assume 
that the individual's death was caused by being placed in restraints or 
in seclusion.


3. Barrage of continued concerns from advocacy groups and the Congress 
to publish this regulation, as well as requests from facilities for 
guidance.


4. Lack of protection for special needs populations, such as children, 
adolescents, persons with mental illness, developmental disabilities, 
or co-occurring mental retardation who are disproportionately affected 
by the usage of restraint or seclusion as a common form of 
intervention.


5. Lack of direction to organizations, advocacy groups and more than 
32,350 facilities for developing common definition.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           09/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Frank Sokolik
Division Director, Center for Medicaid and State Operations
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S2-13-23
7500 Security Boulevard
S2-13-23
Baltimore, MD 21244
Phone: 410 786-7089
RIN: 0938-AL26
_______________________________________________________________________
HHS--CMS
59. PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT PSYCHIATRIC FACILITIES FY 
2004 (CMS-1213-F)
Priority:


Other Significant

[[Page 72492]]

Legal Authority:


PL 106-113; Sec 124 of the Social Security Act ; Sec 1886 of the Social 
Security Act


CFR Citation:


42 CFR 412, subpart N


Legal Deadline:


NPRM, Statutory, October 1, 2002, NPRM.


Abstract:


This rule sets forth a prospective payment system (PPS) for inpatient 
psychiatric facilities and psychiatric units.


Statement of Need:


This rule sets forth a PPS for psychiatric hospitals and psychiatric 
part units. It would replace the current TEFRA payment mechanism for 
inpatient psychiatric facilities (IPF).


Summary of Legal Basis:


Section 124 of Balanced Budget Refinement Act of 1999 mandated 
implementation of an 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 budget-neutral payment system 
may adversely affect certain classes of facilities.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 66919                                    11/28/03
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State


Agency Contact:
Lana Price
Director, Division of Chronic Care Management, Chronic Policy Group
Department of Health and Human Services
Centers for Medicare & Medicaid Services
C5-05-27
Center for Medicare Management
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4533
RIN: 0938-AL50
_______________________________________________________________________
HHS--CMS
60. HOSPITAL PATIENTS' RIGHTS COP-STANDARD SAFETY COMPLIANCE COMMITTEES 
(CMS-3120-P)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 1395bb; 42 USC 1395x; 42 USC 1396d


CFR Citation:


42 CFR 482


Legal Deadline:


None


Abstract:


This proposed rule would allow hospitals to waive the current 
requirement that a physician or licensed independent practitioner 
perform a one-hour face-to-face evaluation of a patient in restraint or 
seclusion for the purpose of behavior management. Under this proposed 
rule, a hospital could choose to have the one-hour assessment performed 
by another practitioner, such as a registered nurse, if that hospital 
established a Protections Compliance Committee to oversee the use of 
restraint or seclusion


Statement of Need:


The hospital patients' rights regulation was published in the Federal 
Register as an interim final rule on July 2, 1999 and became effective 
on August 2, 1999 (see 42 C.F.R. 482.13). Since then, the hospital 
industry and physicians have asserted that the requirement that a 
physician or licensed independent practitioner (LIP) evaluate a patient 
within one hour of the initiation of an intervention, contained at 
section 482.13(f)(3)(ii)(C), is too burdensome. In the interim final 
rule, we stated ``in situations where a restraint must be used for 
behavior management, increased vigilance is required because of the 
heightened potential for harm or injury as the patient struggles or 
resists. Furthermore, there is an immediate need for assessment of what 
has triggered this behavior and for continuous monitoring of the 
patient's condition.'' Therefore, we specified that a physician or LIP 
evaluate the patient face-to-face within one hour of the application of 
restraint or the use of seclusion.


This proposed rule would allow a hospital to waive the current 
requirement that a physician or LIP perform a face-to-face evaluation 
of a patient in restraint or seclusion for behavior management within 
one hour of the initiation of restraint or seclusion. In lieu of the 
one hour face-to-face evaluation by a physician or LIP, the hospital 
would be able to designate a registered nurse (RN) to perform the 
evaluation if the hospital also creates a Protections Compliance 
Committee (PCC) to oversee the hospital's use of restraint or 
seclusion.


Summary of Legal Basis:


Hospitals must meet certain conditions 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. The statute (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 modifying the current CoP that requires a physician to 
perform the one-hour evaluation to allow an appropriately trained RN to 
perform the evaluation without the added PCC. However, in response to 
advocacy group concerns that this would lessen the protections already 
afforded patients in hospitals, we opted not to use this approach.


Anticipated Cost and Benefits:


Because the provisions of this rule would be voluntary and we have no 
data to indicate how many hospitals would participate, it is difficult 
to determine the amount of any economic impact on an individual 
hospital. We would expect that a hospital, in choosing this option, 
would weigh costs and benefits of requiring a physician or LIP to 
perform the one

[[Page 72493]]

hour evaluation versus the costs and benefits of forming a Protections 
Compliance Committee.


Risks:


This proposed rule is intended to encourage the emphasis of patient 
safety in hospitals, while offering some relief from perceived burden.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Nancy Archer
Office of Clinical Standards and Quality
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S3-05-27
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-0596
RIN: 0938-AM39
_______________________________________________________________________
HHS--CMS

                              -----------

                            FINAL RULE STAGE

                              -----------

61. USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES 
PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 
(CMS-2065-F)
Priority:


Other Significant


Legal Authority:


42 USC 1302; 42 USC 1396d


CFR Citation:


42 CFR 441; 42 CFR 483


Legal Deadline:


None


Abstract:


This final rule addresses standards of practices that residential 
treatment facilities providing inpatient psychiatric services for 
individuals under age 21 must meet with regard to the use of restraints 
and seclusion.


Statement of Need:


The standards were developed to eliminate the risk to children and 
adolescents from inappropriate restraint and seclusion that were 
substantiated by reports of deaths and injuries that occurred in these 
facilities. This final rule will clarify and revise the regulations in 
response to public comments that were received on the previous interim 
final rules.


Summary of Legal Basis:


Section 1902(a)(9)(A) of the Social Security Act (the Act) requires the 
State health agency or other State medical agency to establish and 
maintain health standards for private and public institutions in which 
recipients of medical assistance, under the State plan, may receive 
care or services. Section 1905(h) of the Act defines the term 
``impatient psychiatric hospital services for individuals under age 
21'' as inpatient services that are provided in an institution (or 
distinct part hereof) that is a psychiatric hospital or in another in 
patient setting that the Secretary has specified in regulations. In 
this final rule, we are defining ``psychiatric residential treatment 
facilities'' as an inpatient setting in conformity with the definition 
of an institution as set forth in section 1905(h)of the Act.


The Children's Health Act (CHA) of 2000 (Pub. L. 106-310), which 
amended the Public Health Section of the Act to require the health care 
facilities receiving support in any form from any program supported in 
whole or in part with funds appropriated to any Federal department or 
agency shall protect and promote the rights of each resident of the 
facility, including the right to be free from any restraints or 
involuntary seclusion imposed for purposes of discipline or 
convenience. The Children's Health Act permits the Secretary to issue 
regulations that afford residents greater protections regarding 
restraint and seclusion than the standards published in the new law. 
Our final rule provides greater protections than those required in 
section 3207 of the Children's Health Act.


Alternatives:


None.


Anticipated Cost and Benefits:


The average costs for psychiatric residential treatment facilities to 
implement this rule are estimated to be around $65 million per year for 
the first 5 years.


We believe that requirements of this rule will have a direct impact on 
the use of restraint and seclusion in residential treatment facilities. 
Specifically, we are limiting the use of restraint and seclusion to 
emergency safety situations only and have specifically defined an 
emergency safety situation for purposes of this rule. By limiting the 
use of restraint and seclusion we expect to better protect residents 
from the use of restraint and seclusion as a means of coercion, 
discipline, staff convenience, or retaliation.


Risks:


There is the potential for great risks to facility residents if the 
current regulations are not revised and reports of inappropriate 
restraint and seclusion practices continue.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru66 FR 7148                                     01/22/01
60-Day Delay of 66 FR 15800ate To 05/22/2001                   03/21/01
Interim Final Rule Comment Period End                          03/23/01
Interim Final Rule Effective                                   03/23/01
Interim Final Ru66 FR 28110t with Clarification                05/22/01
Interim Final Rule Comment Period End                          07/23/01
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Larry Cutler
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S2-14-26
Center for Medicaid and State Operations
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-5903
RIN: 0938-AJ96

[[Page 72494]]

_______________________________________________________________________
HHS--CMS
62. REVISIONS TO THE MEDICARE APPEALS PROCESS (CMS-4004-FC)
Priority:


Other Significant


Legal Authority:


Sec 521 of BIPA


CFR Citation:


42 CFR 405


Legal Deadline:


NPRM, Statutory, October 1, 2002, NPRM.


Abstract:


This final regulation with comment incorporates recommendations from a 
Social Security Administration (SSA)/Health and Human Services (HHS) 
workgroup to improve the Administrative Law Judge (ALJ) hearing 
process. ALJ-conducted hearings for Medicare fee-for-service and 
managed care cases are governed by SSA disability regulations which 
apply to SSA disability cases, not to Medicare. Regulations improve the 
integrity of the appeals process, because they are specific to the 
adjudication of Medicare cases. They also incorporate the revisions to 
appeals policy required by section 521 of Benefits Improvement and 
Protection Act of 2000 (BIPA).


Statement of Need:


This regulation is necessary to implement section 1869(b)(1)(f) of the 
Social Security Act (the Act), which requires the establishment of an 
expedited appeals process enabling beneficiaries to appeal discharges 
from provider settings. This process will apply to provider discharges 
and service terminations by skilled nursing facilities, home health 
agencies, and comprehensive outpatient rehabilitation facilities. The 
process will be similar to the expedited review process that will be 
available to Medicare+Choice enrollees beginning in January under our 
April 4, 2003 final rule. Quality improvement organizations will likely 
conduct these reviews.


Summary of Legal Basis:


Section 1869(b)(1)(F) of the Act, as amended by section 521 of the 
Benefits Improvement & Protection Act of 2000, requires the Secretary 
to implement appeal procedures by October 1, 2002.


Alternatives:


None, the changes are required by the statute.


Anticipated Cost and Benefits:


The cost of implementing this rule will be $34.2 million to the Federal 
Government. The benefit will result in new and expanded appeal rights 
for beneficiaries.


Risks:


The failure to publish this regulation will result in further delay of 
a new expedited appeals process for beneficiaries.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 69312                                    11/15/02
Final Rule                                                     04/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Agency Contact:
Michele Edmondson-Parrott
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S1-05-06
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6478
RIN: 0938-AL67
_______________________________________________________________________
HHS--CMS
63. [bull] REVISIONS TO THE APPEALS PROCESS FOR INITIAL CLAIM 
DETERMINATIONS (CMS-4064-F)
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


Sec 521 of BIPA


CFR Citation:


42 CFR 40S


Legal Deadline:


None


Abstract:


This final rule will revise the Medicare appeals process by adding 
five-tiered (five levels) of review. It will remove the distinction 
between the processing of initial determination and appeals under part 
A and part B required by section 521 of Benefits Improvement and 
Protection Act of 2000 (BIPA).


Statement of Need:


This regulation is necessary to implement section 1869 of the Social 
Security Act (the Act). Major provisions include the following:


1. The implementation of identical rules for Medicare part A and B 
claims appeals.


2. The establishment of qualified independent contractors (QICs), with 
panels of physicians making medical necessity determinations.


3. Shorter time frames at all appeal levels.


4. Other improvements to the Medicare claims appeals process.


Key components of the final rule include new notice and evidence 
submission standards, the procedures for adjudicating escalated cases, 
the promulgation of Medicare-specific regulations for administrative 
law judge hearings, the feasibility of telephone and in-person appeals 
under the new BIPA timeframes, reopening rules, and transition policies 
for the move from the existing appeals procedures.


Summary of Legal Basis:


Section 1869(b) of the Act, as amended by section 521 of Benefits 
Improvement & Protection Act of 2000, requires the Secretary to 
implement claims appeal procedures by October 1, 2002.


Alternatives:


None, the changes are required by the statute.


Anticipated Cost and Benefits:


None, the changes are required by the statute.


Risks:


None, the changes are required by the statute.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Final Action                                                   07/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Undetermined


Government Levels Affected:


Federal

[[Page 72495]]

Agency Contact:
Michele Edmondson-Parrott
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
S1-05-06
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-6478
RIN: 0938-AM73
BILLING CODE 4150-24-S

[[Page 72496]]

DEPARTMENT OF HOMELAND SECURITY (DHS)
Statement of Regulatory Priorities
The President signed the Homeland Security Act on November 25, 2002. 
DHS officially ``stood up'' as an agency on January 24, 2003, and most 
of its component agencies transferred in on March 1, 2003. The final 
components and agencies were in place within DHS by July 1, 2003. The 
Homeland Security Act created a new executive department of the United 
States with the following missions:
[sbull] Prevent terrorist attacks within the United States;
[sbull] Reduce America's vulnerability to terrorism;
[sbull] Minimize the damage and assist in the recovery from terrorist 
            attacks that do occur within the United States;
[sbull] Carry out all functions of entities transferred to the 
            Department, including by acting as a focal point regarding 
            natural and manmade crises and emergency planning;
[sbull] Ensure that the functions of entities transferred to the 
            Department that are not related directly to securing the 
            homeland are not diminished or neglected except by a 
            specific explicit Act of Congress;
[sbull] Ensure that the overall economic security of the United States 
            is not diminished by efforts, activities, and programs 
            aimed at securing the homeland; and
[sbull] Monitor connections between illegal drug trafficking and 
            terrorism, coordinate efforts to sever such connections, 
            and otherwise contribute to efforts to interdict illegal 
            drug trafficking.
 The first and overriding priority of the Department 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. Accordingly, the Department has issued a comprehensive 
suite of maritime security regulations that strengthen and add 
additional protective layers of defense to the Nation's port security. 
The regulations specify requirements for security assessments, 
development of security plans, mandate access control, security 
monitoring, and implement physical, passenger, persons, baggage and 
cargo security measures. Our skies are safer by requiring security 
programs for aircraft weighing 12,500 pounds or more. Additionally, the 
Department is requiring private charter security rules. These rules 
will require that individuals and their accessible property are 
screened before boarding and that flight crews have criminal history 
background checks. Our borders are safer through the implementation of 
many security-based measures including the Student and Exchange Visitor 
Information System that provides for tracking and monitoring 
functionality and for maintaining current information on nonimmigrant 
students and exchange visitors; and through the proposed implementation 
of a new entry-exit system, the U.S. Visitor and Immigrant Status 
Indication Technology System, designed to make entering the United 
States easier for legitimate tourist, student, and business travelers 
while making it more difficult to enter the United States illegally 
through the implementation of biometrically authorized documents. The 
Department, also, is promulgating advanced cargo reporting regulations 
to facilitate timely targeting of shipments of goods for heightened 
scrutiny. These rules are intended to facilitate both commerce and 
security by speeding decision-making and enhancing certainty for the 
trade community. The Department is also facilitating antiterrorism 
initiatives through various rulemaking projects, including the 
implementing regulations under the Support Antiterrorism by Fostering 
Effective Technologies Act of 2002. This rule provides incentives to 
persons to develop antiterrorism technologies. The Department is 
encouraging the public, through rulemaking, to voluntarily submit 
information regarding security vulnerabilities that will assist the 
Department in developing strategies for protecting critical 
infrastructure.
 DHS continues to fulfill its charge to carry out functions within the 
Department that are not directly related to securing the homeland. Most 
notably, the proposed rulemakings for disaster relief that will provide 
Federal assistance to individuals and households affected by natural 
and manmade disasters, and the issuing of proposed standards for living 
organisms in Ship's ballast water discharged in the United States. In 
the trade arena, DHS issued regulations that facilitated free trade in 
implementing various Andean, Caribbean, and African preference programs 
enacted last year by Congress. These rules provide the framework in 
which traders make investment-backed decisions to avail free trade.
BILLING CODE 4410-10-S

[[Page 72497]]

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 (FY) 2004 highlights the Department's most 
significant regulations and policy initiatives, as established by 
Secretary Martinez, for the upcoming fiscal year. This regulatory plan 
reflects HUD's role as the primary Federal agency responsible for 
expanding homeownership, increasing access to affordable housing free 
from discrimination, improving and developing the Nation's communities, 
and addressing the housing needs of our Nation's most vulnerable. 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 is also committed to 
breaking down the barriers that keep too many families--especially 
minorities--from owning their own home. Toward this goal, HUD has taken 
significant steps to make the homebuying process less confusing and 
less expensive, and has and will continue to reduce predatory lending 
practices while enhancing accountability in the home purchase process.
 While HUD is passionate about its mission to increase the ranks of 
America's homeowners, its agenda is broad and covers every aspect of 
single-family and multifamily housing, the special needs of vulnerable 
citizens and urban and economic development. Touching America's 
communities, HUD is committed to providing the capital and resources to 
improve economic conditions in distressed communities and helping local 
organizations access the resources they need to make their communities 
more livable. Touching the lives of individuals and families with 
special needs, HUD is committed to ending chronic homelessness, and 
ensuring adequate housing for the elderly, persons with disabilities, 
and people living with HIV/AIDS. HUD's mission is also to promote 
affordable housing and improve the physical quality and management 
accountability of public and assisted housing.
 Under the leadership of Secretary Martinez, HUD's regulatory plan for 
FY 2004 builds upon the successes of the previous fiscal year through 
regulations that are designed to expand homeownership opportunities, 
promote decent affordable housing for all, particularly the most 
vulnerable Americans, and strengthen America's communities.
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, as well as 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 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 a 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 continues its commitment to reduce predatory lending practices and 
enhance accountability in the home purchase process. Predatory lending 
may be undertaken by creditors, brokers, or home improvement 
contractors. It involves deception or fraud, manipulating the borrower 
through aggressive sales tactics, or taking unfair advantage of a 
borrower's lack of understanding about loan terms. 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. Predatory lending poses a barrier to expanding 
homeownership, barring significant numbers of Americans from owning a 
piece of the American Dream. Predatory lending also threatens 
homeownership by placing on borrowers loans that are so expensive or 
have such high rates that borrowers are unable to pay and therefore 
risk default on their loans.
 To combat predatory lending, HUD will continue to pursue regulations 
that enhance lender accountability for appraisals, establish criteria 
by which home inspectors are placed on and removed from the Federal 
Housing Administration (FHA) Inspector Roster, and strengthen FHA's 
Credit Watch Initiative. Other rules will enhance accountability of 
nonprofits participating in the Section 203(k) Rehabilitation Program 
and enhance lender compliance and accountability.
 Regulatory Action: Revisions to FHA Credit Watch
 Under the FHA Credit Watch Termination Initiative, FHA systematically 
reviews mortgagees' early default and claim rates, that is, defaults 
and claims on mortgagees' loans during the initial 24 months following 
endorsement. Mortgagees with excessive default and claim rates are 
considered to be on Credit Watch status and, in cases of more severe 
performance deficiencies, HUD may terminate the mortgagee's loan 
origination approval authority. This final rule will amend HUD's 
regulations for the FHA Credit Watch Termination Initiative and provide 
greater safeguards for the FHA mortgage insurance fund. Among the

[[Page 72498]]

revisions to be made, this rule will provide for a fully computerized 
Credit Watch notification process through use of the FHA Neighborhood 
Watch Early Warning System. As a result, a mortgagee will be considered 
to be on Credit Watch status if, at any time, it has a default and 
claim rate of higher than 150 percent of the normal rate, and its 
origination approval agreement has not been terminated. The rule will 
also prohibit a mortgagee that has received a notice of proposed 
termination of its origination approval agreement from establishing a 
new branch for the origination of FHA-insured mortgages in the lending 
area covered by the proposed termination.
 Regulatory Action: Single-Family Mortgage Insurance; Lender 
Accountability for Appraisals
 The success of the FHA single-family mortgage insurance program, and 
HUD's ability to protect the FHA Insurance Fund, begins with the 
quality of appraisals on properties that secure FHA mortgages. Most 
appraisers perform appraisals in accordance with FHA standards. There 
are some instances, however, in which some lenders tacitly require 
appraisers to make the appraisal computations match the sales price to 
ensure that a home sale and mortgage loan closes for the appraiser to 
obtain additional business. Other instances have occurred, including 
recent episodes of predatory lending activity in several areas of the 
country, whereby lenders, realtors, investors, and others have 
participated in so-called property ``flipping'' schemes to inflate home 
prices and perpetuate sales that generate fees and charges to 
participants in the transaction. There are additional examples of 
fraudulent activity that could have been prevented if the underwriters 
had properly reviewed the appraisal reports. This rule will clarify and 
strengthen HUD's regulations concerning the responsibilities of lenders 
approved by the FHA in the selection of appraisers to perform 
appraisals on properties that will be the security for FHA-insured 
mortgages. Among other things, the rule will provide that lenders are 
responsible for the quality of appraisals on properties securing FHA-
insured mortgages. Lenders that knowingly submit appraisals to HUD that 
do not meet FHA requirements will be subject to the imposition of 
sanctions by the HUD Mortgagee Review Board. HUD believes these changes 
will help protect the FHA Insurance Fund, ensure better compliance with 
appraisal standards, and help to ensure that homebuyers receive an 
accurate statement of appraised value.
Priority: Expanding Homeownership--Helping Existing Homeowners Keep 
Their Homes
 It is not enough to help more families become homeowners. HUD is also 
increasing the focus on assisting new homeowners to maintain their 
homeownership status. Among the ways HUD is advancing this goal is 
through homeownership counseling, foreclosure prevention activities, 
and better monitoring of appraisals. In particular, the requirement 
imposed on FHA lenders to engage in loss mitigation has proven a 
successful strategy for assisting homeowners to keep their homes and 
will be strengthened.
Regulatory Action: Treble Damages for Failure To Engage in Loss 
Mitigation
 The HUD Appropriations Act for fiscal year1999 amended the National 
Housing Act (NHA) to add a triple penalty for failure to engage in 
appropriate loss mitigation to the existing civil money penalty system. 
Section 230(a) of title II of the NHA, as amended, makes it mandatory 
for the mortgagee, upon the default of a single-family mortgage, to 
engage in loss mitigation actions, including, but not limited to, 
special forbearance, loan modification, and deeds in lieu of 
foreclosure, for the purpose of providing alternatives to foreclosure. 
This proposed rule would amend HUD's civil money penalty regulations to 
reflect HUD's authorization to impose treble damages on a mortgagee for 
any mortgage for which the mortgagee had a duty but failed to engage in 
appropriate loss mitigation actions. The proposed rule follows 
publication of an advanced notice of proposed rulemaking (ANPRM) and 
takes into consideration public comments received on the ANPRM.
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 provide a positive, stable environment for children. Indeed, in 
areas where homeownership flourishes, neighborhoods are more stable, 
residents are more civic-minded, schools are better, and crime rates 
decline. Homeownership has a positive and pronounced effect on the 
nation's economy. Under the leadership of Secretary Martinez, HUD is 
determined to simplify the home buying process and, in doing so, expand 
homeownership to thousands of first-time American 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.
 HUD's rulemaking on RESPA (RESPA: Simplifying and Improving the 
Process of Obtaining Mortgages To Reduce Settlement Costs to Consumers) 
was commenced to achieve these objectives. HUD's rule on RESPA has 
proposed 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 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--The American Dream Downpayment 
Initiative
 HUD is committed to helping greater numbers of lower-income and 
minority families realize the American dream. Census figures indicate 
that while nearly 70 percent of all American households are homeowners, 
less than half of all African-American and Hispanic families own their 
own homes. To remove the barriers that cause this discrepancy, HUD 
intends to provide downpayment assistance through its American Dream 
Downpayment Initiative. The initiative will provide grants to States 
and local governments

[[Page 72499]]

under HUD's HOME Investment Partnership program. Enacted into law in 
1992, the HOME program has successfully helped to expand the supply of 
decent, affordable housing for deserving families by providing funds to 
communities to address housing shortages and needs. HUD believes that 
reducing homebuying costs will help people achieve the American dream 
of homeownership and help to sustain the momentum in our nation's 
housing boom.
 Regulatory Action: The HOME Investment Partnerships Program; American 
Dream Downpayment Initiative
 This rule establishes regulations for a new homebuyer assistance 
initiative under the HOME Program, which is known as the American Dream 
Downpayment Initiative (ADDI). The purpose of the ADDI is to assist 
participating jurisdictions to address one of the most formidable 
barriers to homeownership by low-income families--the cost of the 
downpayment necessary for purchase of a home. Through the ADDI, HUD 
will make formula grants to HOME participating jurisdictions for the 
purpose of providing downpayment assistance to low-income families. HUD 
must make the ADDI funds available in accordance with a formula. This 
rule will codify the formula for allocation of ADDI funds to HOME 
participating jurisdictions, identify eligible activities and costs 
under the ADDI, and establish other applicable requirements.
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 Enterprises)
 Through this rule, HUD will issue new housing goal levels for the 
purchase of mortgages by Fannie Mae and Freddie Mac for future years. 
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: Supporting Community and Economic Development
 Under Secretary Martinez's leadership, HUD has refocused its energy 
toward its core missions. One core mission is community and economic 
development. Community development activities include many different 
programs that provide assistance to a variety of grantees. One program, 
the Community Development Block Grant (CDBG) program, provides annual 
grants on a formula basis to entitled cities, urban counties, and 
States for the purpose of developing viable urban communities providing 
decent housing and a suitable living environment. The CDBG program is 
also designed to expand economic opportunities, principally for low- 
and moderate-income persons. Another program, the Community Renewal 
Initiative for Renewal Communities/ Empowerment Zones/ Enterprise 
Communities (RC/EZ/EC), offers an innovative approach to 
revitalization. Underlying each of these programs is the strong belief 
that economic development improves communities and the citizens of 
those communities.
Regulatory Action: CDBG Funding for Brownfields Activities
 This proposed rule would revise the CDBG program regulations to 
clarify the eligibility of brownfields cleanup, development or 
redevelopment within existing program eligibility categories. As a 
result, the rule will improve the ability of entitlement communities 
and States' grant recipients to use CDBG funds for brownfields 
activities. By making the cleanup and development of environmentally 
contaminated properties eligible for funding, the Department will move 
toward achieving one of the objectives under the CDBG Program, which is 
eliminating slums or blighting conditions.
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 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: Capital Fund Program
 Section 519 of QHWRA amended section 9 of the United States Housing 
Act of 1937 (1937 Act) to provide a Capital Fund, to be established by 
HUD for the purpose of making assistance available to public housing 
authorities (PHAs) to carry out capital and management improvement 
activities. This proposed rule would establish the full regulatory 
framework for the Capital Fund Program. The Capital Fund Program 
addresses the capital and management improvement needs of PHAs and 
replaces the Comprehensive Grant Program and the Comprehensive 
Improvement Assistance Program. This proposed rule would complement the 
final rule that ensures the effective and timely obligation and 
expenditure of funds under the Public Housing Capital Fund Program.
The Priority Regulations that Comprise HUD's FY 2004 Regulatory Plan
 A more detailed description of the priority regulations that comprise 
HUD's FY 2004 regulatory plan follows.
_______________________________________________________________________
HUD--Office of the Secretary (HUDSEC)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

64. TREBLE DAMAGES FOR FAILURE TO ENGAGE IN LOSS MITIGATION (FR-4553)
Priority:


Other Significant


Legal Authority:


12 USC 1715u; 12 USC 1735f-14; 12 USC 1701q-1; 12 USC 1703; 1735f-15; 
15 USC 1717a; 28 USC 2641 note; 12 USC 1709; 12 USC 1710; 12 USC 1715b; 
42 USC 3535(d)


CFR Citation:


24 CFR 30; 24 CFR 203

[[Page 72500]]

Legal Deadline:


None


Abstract:


This rule would implement sections 601(f), (g), and (h) of the fiscal 
year 1999 HUD Appropriations Act (Pub. L. 105-276, approved October 21, 
1998). These sections amend the National Housing Act, which establishes 
the basic framework for HUD's single family mortgage insurance 
programs. Specifically, section 601(f) amends section 230 of the 
National Housing Act (42 U.S.C. 1715u) (entitled Authority to Assist 
Mortgagors in Default) to provide that, upon default of an insured 
single family mortgage, lenders must engage in loss mitigation 
activities for the purpose of providing an alternative to foreclosure. 
Further, sections 601(g) and (h) amend section 536 of the National 
Housing Act (12 U.S.C. 1735f-14) (entitled Civil Money Penalties 
Against Mortgagees, Lenders, and Other Participants in FHA Programs) to 
provide for the imposition of treble civil money penalties on lenders 
that fail to engage in loss mitigation activities, as required under 
amended section 230.


Statement of Need:


This rule implements a law that allows HUD to assess civil money 
penalties for specific types of mortgage lender violations, including 
failure to engage in loss mitigation. The law also directs HUD to 
implement regulations as it determines necessary to implement the civil 
money penalty provisions. This rule is necessary to encourage certain 
lenders that rarely engage in loss mitigation activities to do so. 
Failure to engage in loss mitigation leads to additional claims on 
FHA's insurance funds. Greater emphasis by certain lenders on loss 
mitigation will act to reduce those claims and enhance the health of 
the funds.


Summary of Legal Basis:


Section 230 of the National Housing Act (NHA), (12 U.S.C. 1715u), 
requires mortgage lenders utilizing FHA-insured financing to engage in 
loss mitigation actions upon the default of any insured mortgage. 
Section 536(b)(1)(I) of the NHA (12 U.S.C. 1735f-14(b)(1)(I)) includes 
failure to engage in loss mitigation among the activities for which HUD 
may assess civil penalties. Section 536(a) of the NHA (12 U.S.C. 1735f-
14(a)) provides that in the case of failure to engage in loss 
mitigation, the penalty may be tripled. Section 536(h) of the NHA (12 
U.S.C. 1735f-14(h)) provides that HUD shall issue regulations to 
implement these provisions as it determines is appropriate.


Alternatives:


This action is a rule of general applicability and future effect that 
does not fall into any of the rulemaking exceptions.


Anticipated Cost and Benefits:


This rule will penalize lenders that have particularly poor records in 
the area of loss mitigation. By encouraging these lenders to engage in 
loss mitigation activities upon default, this rule will provide 
benefits to the insurance fund in the form of reduced claims on the 
insurance fund and hence reduced payouts.


Risks:


This rule imposes no risks to public health, safety, or the 
environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           65 FR 76520                                    12/06/00
ANPRM Comment Period End                                       02/05/01
NPRM                                                           01/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Michael Reyes
Office of the Deputy Assistant Secretary for Single Family Housing
Department of Housing and Urban Development
Office of the Secretary
Phone: 405 553-7576
RIN: 2501-AC66
_______________________________________________________________________
HUD--HUDSEC
65. 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 1723i; 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 going 
forward with the objective of ensuring that the two enterprises fully 
address the housing finance needs of very low-, 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

[[Page 72501]]

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 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            Determined                                        To Be
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--HUDSEC

                              -----------

                            FINAL RULE STAGE

                              -----------

66. AMERICAN DREAM DOWNPAYMENT INITIATIVE (FR-4832)
Priority:


Other Significant


Legal Authority:


42 USC 3535(d); 42 USC 12701 to 12839


CFR Citation:


24 CFR 92


Legal Deadline:


None


Abstract:


This rule establishes regulations for the American Dream Downpayment 
Initiative (ADDI). Through the ADDI, HUD will make formula grants to 
participating jurisdictions under the HOME Investment Partnerships 
program for the purpose of assisting low-income families achieve 
homeownership. HUD must make the ADDI funds available in accordance 
with a formula. This rule codifies the formula for allocation of ADDI 
funds to HOME participating jurisdictions, identifies eligible 
activities and costs under the ADDI, and establishes other applicable 
requirements. This rule specifies that ADDI funds may be used for 
downpayment assistance towards the purchase of single family housing by 
low-income families.


Statement of Need:


Increasing homeownership opportunities is an important national goal. 
As noted in the National Affordable Housing Act, there is a critical 
need to increase the supply of decent, safe, and sanitary housing for 
all Americans, particularly among low-income families. ADDI will play 
an important role in providing increased homeownership opportunities 
and in meeting Secretary Martinez's commitment of adding 5.5 million 
new minority homeowners by 2010. This rule will codify the formula for 
the allocation of ADDI funds to HOME participating jurisdictions.


Summary of Legal Basis:


Title II of the National Affordable Housing Act authorizes, through the 
HOME program, funding to participating jurisdictions for various 
housing purposes, including strengthening public-private partnerships 
to increase the supply of affordable housing, including homeownership 
opportunities. The ADDI is a statutorily created homebuyer assistance 
initiative under the HOME program. The purpose of the initiative is to 
assist participating jurisdictions to address one of the most 
formidable barriers to homeownership by low-income families -- the cost 
associated with the purchase of a home.


Alternatives:


The ADDI will be incorporated as part of the HOME program regulations, 
which require rulemaking.


Anticipated Cost and Benefits:


Additional administrative costs of this rule should be minimal since 
the formula allocation of this program is similar to the existing HOME 
formula allocation. The benefits of increased homeownership 
opportunities to the economy, the stability of communities, and to 
families who are currently under--housed, on the other hand, are high.


Risks:


This rule imposes no risks to public health, safety, or the 
environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             06/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Virginia Sardone
Director, Program Policy Division
Department of Housing and Urban Development
Office of Community Planning and Development
Phone: 202 708-2470
RIN: 2501-AC93

[[Page 72502]]

_______________________________________________________________________
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:


None


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                                                           02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Ivery Himes
Asset Control Program Manager, Office of Asset Management, Single 
Family Housing
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-1672
RIN: 2502-AH40
_______________________________________________________________________
HUD--OH

                              -----------

                            FINAL RULE STAGE

                              -----------

68. REVISIONS TO FHA CREDIT WATCH TERMINATION INITIATIVE (FR-4625)
Priority:


Other Significant


Legal Authority:


12 USC 1703; 12 USC 1709; 12 USC 1715b; 42 USC 3535(d)


CFR Citation:


24 CFR 202


Legal Deadline:


None


Abstract:


This rule would make several amendments to HUD's regulations for the 
Federal Housing Administration (FHA) Credit Watch Termination 
Initiative. Under the Credit Watch Termination Initiative, HUD 
identifies mortgagees with unsatisfactory performance levels and takes 
ameliorative action at an early stage. The rule states that mortgagees 
will be responsible for using HUD's Electronic Neighborhood Watch Early 
Warning System to monitor their performance. Among other changes, the 
rule also prohibits a mortgagee that has received a notice of proposed 
termination of its origination approval agreement from establishing a 
new branch for the origination of FHA-insured mortgages in the lending 
area covered by the proposed termination. The rule also establishes 
that the default and claim thresholds underlying the Credit Watch 
Termination Initiative apply to both underwriting and originating 
mortgagees.


Statement of Need:


Credit Watch is intended to increase lender accountability. Under 
Credit Watch, HUD reviews the number of defaults and claims on 
mortgages originated by each mortgagee in the geographic area served by 
a HUD field office. Mortgages with excessive default and claim rates 
are placed on Credit Watch Status and, in cases of more severe 
performance deficiencies, HUD may terminate the mortgagee's loan 
origination approval authority. This rule will strengthen HUD's 
oversight of mortgages, providing for electronic notification of Credit 
Watch Status and ensuring that mortgages whose loan origination 
authority has been revoked do not evade this action by establishing a 
new branch for the origination of FHA-insured mortgages in the lending 
area covered by the termination notice.


Summary of Legal Basis:


HUD has authority to address deficiencies in the performance of 
lenders' loans as provided in the HUD mortgagee approval regulations at 
24 CFR 203.3.


Alternatives:


The changes made by this final rule would modify regulatory 
requirements and, therefore, must also be promulgated through 
regulation.


Anticipated Cost and Benefits:


This rule should have minimal impact for mortgagees that have in place, 
and are effectively using, an adequate

[[Page 72503]]

quality control plan for loan origination. Credit watch will eliminate, 
from the FHA program, mortgagees that have default and claims rates 
that significantly exceed the national rate. As a result, the rule will 
help protect the FHA Insurance Fund, and benefit the public and most 
FHA mortgagees.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 15906                                    04/01/03
NPRM Comment Period End                                        06/02/03
Final Action                                                   06/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Phillip A. Murray
Director, Office of Lender Activities and Program Compliance
Department of Housing and Urban Development
Office of Housing
P3214
451 7th Street SW.
Washington, DC 20410
Phone: 202 708-1515
RIN: 2502-AH60
_______________________________________________________________________
HUD--OH
69. LENDER ACCOUNTABILITY FOR APPRAISALS (FR-4722)
Priority:


Other Significant


Legal Authority:


12 USC 1708 to 1710; 12 USC 1715b; 12 USC 1715u; 12 USC 1735f-14; 42 
USC 3535(d)


CFR Citation:


24 CFR 25; 24 CFR 203


Legal Deadline:


None


Abstract:


This rule clarifies and strengthens HUD's regulations concerning the 
responsibilities of lenders approved by the Federal Housing 
Administration (FHA) in the selection of appraisers to perform 
appraisals on properties that will be the security for FHA-insured 
mortgages. First, the rule provides that lenders are responsible for 
the quality of appraisals on properties securing FHA-insured mortgages. 
Further, the rule specifically provides that lenders that knowingly 
submit appraisals to HUD that do not meet FHA requirements are subject 
to the imposition of sanctions by the HUD Mortgagee Review Board. The 
rule applies to both sponsor lenders, who underwrite loans, and loan 
correspondent lenders, who originate loans on behalf of their sponsors. 
HUD believes these changes will help protect the FHA Insurance Fund, 
ensure better compliance with appraisal standards, and help to ensure 
that homebuyers receive an accurate statement of appraised value. This 
final rule follows publication of a January 13, 2003, proposed rule and 
takes into consideration the public comments on the proposed rule.


Statement of Need:


The success of the FHA single family mortgage insurance program, and 
HUD's ability to protect the FHA Insurance Fund, begins with the 
quality of appraisals on properties that secure FHA mortgages. HUD 
believes that it is in the public interest to adopt rules that require 
lenders to be held responsible for the accuracy and quality of 
appraisals. Adopting such rules would also help to protect first-time 
and low- and moderate-income homebuyers from acquiring over valued 
property and/or property in poor condition.


Summary of Legal Basis:


The National Housing Act provides the method for calculating the 
maximum mortgage amount that FHA can insure. The calculations required 
by the statute are based on the appraised value of the property that is 
security for the mortgage. This authority includes establishing 
appraisal standards as the Secretary may prescribe.


Alternatives:


Nonregulatory initiatives to date have not proven to be sufficiently 
successful in addressing the issue of ensuring consistently accurate, 
high-quality appraisals.


Anticipated Cost and Benefits:


This rulemaking will provide that lenders are responsible for the 
quality of appraisals on properties securing FHA insured mortgages. HUD 
believes these changes will protect the FHA Insurance Fund, ensure 
better compliance with appraisal standards, and help to ensure that 
homebuyers receive an accurate statement of appraised value.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 1766                                     01/13/03
NPRM Comment Period End                                        03/14/03
Final Action                                                   04/00/04
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-AH78
_______________________________________________________________________
HUD--Office of Community Planning and Development (CPD)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

70. COMMUNITY DEVELOPMENT BLOCK GRANT PROGRAM REVISION OF CDBG 
ELIGIBILITY AND NATIONAL OBJECTIVE REGULATIONS (FR-4699)
Priority:


Other Significant


Legal Authority:


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


CFR Citation:


24 CFR 570


Legal Deadline:


None


Abstract:


This rule will improve the ability of entitlement communities and 
States' grant recipients to use Community

[[Page 72504]]

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


Statement of Need:


The purpose of the CDBG Program is to provide decent housing, a 
suitable living environment and expanded economic opportunities, 
primarily for persons of low and moderate income. This rule does not 
add any new eligibility categories to section 105 of the Housing and 
Development Act of 1974, but rather would expand the scope of the 
current listing of eligible activities to include environmental 
remediation and development of contaminated sites. HUD believes that 
these changes will facilitate the use of CDBG funds for economic 
development objectives, reduce the administrative burden on grantees 
and focus efforts on assisting the residents of low- and moderate-
income neighborhoods.


Summary of Legal Basis:


Section 104 of the Housing and Community Development Act of 1974 
establishes certain national objectives for CDBG-assisted activities. 
Among other goals, section 104 makes the prevention or elimination of 
slums or blight a national objective for the CDBG program.


Alternatives:


The changes made by this rule would modify regulatory requirements and, 
therefore, must also be promulgated through regulation.


Anticipated Cost and Benefits:


Grantees will gain the flexibility to use CDBG funds to assist in 
redeveloping a larger universe of properties whose conditions 
negatively influence the condition of the surrounding area. This change 
will stimulate economic development through the redevelopment of 
contaminated industrial properties furthering activities that meet the 
objective of preventing or eliminating slums or blighting conditions.


Risks:


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


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State


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

                              -----------

                          PROPOSED RULE STAGE

                              -----------

71. [bull] CAPITAL FUND PROGRAM (FR-4880)
Priority:


Other Significant


Legal Authority:


42 USC 1437g; 42 USC 1437z-7; 42 USC 3535(d)


CFR Citation:


24 CFR 905


Legal Deadline:


None


Abstract:


This rule will implement the new Capital Fund Program for the capital 
and management improvement needs of public housing agencies. This rule 
will implement the regulatory framework for the Capital Fund Program 
that will govern the use of the assistance made available from the 
Capital Fund formula. The new rule at part 905 will replace and remove 
several other rules that currently govern a PHA's use of HUD assistance 
including part 941--Public Housing Development, and part 968--Public 
Housing Modernization. This rule will continue and expand the 
streamlining of procedures and requirements initiated under the 
Comprehensive Grant and Comprehensive Improvement programs at part 968.


Statement of Need:


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


Summary of Legal Basis:


Sections 518, 519, and 539 of the Quality Housing and Work 
Responsibility Act of 1998 (Pub.L. 105-276, approved October 21, 1998) 
(referred to as QHWRA), amending sections 9 and 5, and adding section 
35(g) of the U.S. Housing Act of 1937.


Alternatives:


The changes made by this rule would modify existing regulatory 
requirements and, therefore, must also be promulgated through 
regulations.


Anticipated Cost and Benefits:


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


Risks:


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

[[Page 72505]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
William Thorson
Director, Office of Capital Improvements
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-1640
RIN: 2577-AC50
BILLING CODE 4210-01-S

[[Page 72506]]

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 388 park units, 540 wildlife 
refuges, 24,000 miles of trails, and approximately 1.7'billion acres 
submerged in offshore waters. The Department protects natural, 
historic, and cultural resources; recovers endangered species; manages 
water projects; manages forests and 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 and 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, establishes and enforces environmental 
standards for coal mining and reclamation operations. In addition, OSM 
administers the abandoned mine land reclamation program, which is 
funded by a fee assessed on each ton of coal produced. Money from these 
fees is placed in a fund that, subject to appropriation, is used to 
reclaim lands and waters impacted by historic mining activities 
conducted before the enactment of the Surface Mining Control and 
Reclamation Act of 1977. Authority to collect the fee is scheduled to 
expire in September 2004 unless reauthorized by Congress. 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. 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. 
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 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.
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.
 The Department is taking over 100 actions to implement the President's

[[Page 72507]]

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 B Alaska. The Minerals Management Service 
proposed a rule in March 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 final rule is expected in the fall. 
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. OSM anticipates that Congress will 
reauthorize the Abandoned Mine Land Fee, which is scheduled to expire 
in September 2004. However, OSM is making contingency rulemaking plans 
should Congress decide otherwise. 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 has issued 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 Department is improving incentives through administrative 
flexibility under the Endangered Species Act. Released for public 
comment in September are proposed rule changes intended to provide 
greater clarity of what is allowable under incidental take permits and 
provide greater private landowner protections under safe harbor 
agreements. The first improvements of procedures relate to enhancement 
of survival permits (actions intended to improve survival or habitat of 
a species) and will refine and clarify the application requirements. 
The second, which relates to the issuing of safe harbor permits, will 
make the process easier to understand and will provide participating 
landowners greater certainty. Comments are expected in October. A final 
rule will follow several weeks later.
 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 Federal policy on research 
misconduct as required by the Office of Management and Budget. The 
policy applies to all Federal agencies and federally funded research, 
whether conducted in-house or by partners at universities or in 
nongovernmental organizations. This 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.
 In 2002, 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.
 On August 22, 2002, the President announced a new initiative that will 
significantly reduce the damage caused by catastrophic wildfires, by 
removing unnecessary regulatory obstacles that hinder active forest 
management to improve forest health. He also called upon Congress to 
work with his Administration to pass legislation that addresses the 
unhealthy forest crisis by expediting procedures for forest thinning 
and restoration projects. In May 2003, the Administration completed 
implementation of the administrative improvements President Bush called 
for as part of his Healthy Forests Initiative. These improvements will 
reduce complex procedures, provide more timely decisions and provide 
great flexibility in emergency situations. These include the use of a 
``categorical exclusion''--established by rule--of administrative means 
to focus necessary but administrative requirements for addressing 
fires; streamlined and focused ``model EA'' template to ensure concise 
environmental assessments for fuels treatment projects; and proposed 
changes, via rule, to ESA regulations designed to allow agencies that 
regularly and routinely achieve ``findings of no adverse impacts'' the 
ability to make a determination that the fuels treatment project will 
not adversely impact species.
The National Park Service has completed a Supplemental Environmental 
Impact Statement regarding snowmobile management in Yellowstone and 
Grand Teton National Parks and John D. Rockefeller, Jr. Memorial 
Parkway. The Record of Decision was signed in March 2003. The ROD 
requires the use of new snowmobile engine technology, otherwise known 
as Best Available Technology, in machines entering the parks. The new 
technology will likely improve air quality problems associated with 
high numbers of users and the use of older machines. The proposed 
regulations will likely reduce adverse economic impact projected to 
result if snowmobiles were to be completely prohibited 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, comply with recent

[[Page 72508]]

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 past year, the Department has worked extensively with the 
Federal Energy Regulatory Commission (FERC), along with the Departments 
of Commerce and Agriculture, to establish a new integrated licensing 
process that will reduce both the time and cost of obtaining a FERC 
hydropower license. In July 2003 FERC issued its new rules.
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.
 In addition, the Department has recently completed a review of its 
NEPA compliance program and proposed new procedures aimed at improving 
public participation and reducing excess paperwork and redundancy of 
effort in the field. This has led to concrete reform measures. On 
August 29, 2003, a draft of the new NEPA reforms was sent to the 
Federal Register for notice and public comment. Once the public 
comments are complete, the changes will be codified in the Department 
and bureau handbooks. The reforms cover a number of areas. They 
include: consensus based management, public participation, community 
based training, use of integrated analysis, adaptive management, and 
tiered and transferred analysis. Each of these concepts is aimed at 
ensuring the field staff have the tools to tailor their approach to the 
NEPA process to local needs and interests. Along with the departmental 
manual changes, policy guidance was distributed to bureaus earlier this 
year on how to implement the major reforms.
 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 finalizing its roads program 
            rule that was developed using the negotiated rulemaking 
            process, which has resulted in a rule that better serves 
            the diverse needs of the Native American community, 
            reflecting the importance of the roads program to the 
            individual tribes and the varying needs of the tribal 
            governments;
[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 has included two phases of snowmobile 
            regulations, the last of which will be concluded this 
            winter.
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 
finalized an interim rule published in April 2002 for one year that 
implements this authority. It has since been extended through 2005.
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. A draft economic analysis and a 
visitor survey each point towards economic benefit to businesses in 
gateway communities, with some costs incurred by non-snowmobile users 
of the parks.
The Future of DOI
 Interior has developed a new 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. 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.
 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, we plan to 
submit only Departmentwide strategic and annual plans to the Congress.

[[Page 72509]]

Bureaus and Offices Within DOI
The following brief descriptions summarize the regulatory functions of 
DOI's major regulatory bureaus and offices.
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 approximately 262 million acres 
of land 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; 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, which 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 
            resource values;
[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.
[sbull] The regulatory program objectives 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 the regulations on grazing 
            administration exclusive of Alaska to remove provisions 
            found unlawful in Federal court. This revision will: Make 
            our procedures more responsive to the needs of livestock 
            operators; protect the public interest in sustained yield 
            use of these lands; and protect the environment.
[sbull] Completing the revision of the regulations on administration of 
            rights-of-way on the public lands 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.
 All BLM regulations affect small businesses because many, if not most, 
business entities that operate on public lands meet the definition of a 
small business established by the Small Business Administration (SBA). 
No BLM regulation is specifically targeted at small business. All BLM 
regulations apply equally to entities not qualified as small 
businesses.
 Of the high priority regulations listed above, the mining and grazing 
regulation projects are probably of particular concern to small 
businesses. Most livestock operators and mining companies are small 
businesses, as classified by SBA.
 The grazing rule will amend in several respects the grazing 
regulations that BLM promulgated on February 22, 1995 (59 FR 29206). It 
will not fundamentally change them. When published, the proposed rule 
will rely on a regulatory flexibility analysis prepared by BLM for the 
1995 final rule. At that time, we determined that the 1995 rule would 
not have a significant impact on a substantial number of small 
entities. That analysis still applies.
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, 
we are finalizing a rule to revise current regulations at 30 CFR part 
203. The rule will 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 to review 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

[[Page 72510]]

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.
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 two are 
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;
[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 working with 
others to conserve, protect, and enhance fish, wildlife, and plants and 
their habitats for the continuing benefit of the American people. Four 
principal mission goals include:
[sbull] The sustainability of fish and wildlife populations. We 
            conserve, protect, restore, and enhance fish, wildlife, and 
            plant populations entrusted to our care. We carry out this 
            mission goal through migratory bird conservation at home 
            and abroad; native fisheries restoration; recovery and 
            protection of threatened and endangered species; prevention 
            and control of invasive species; and work with our 
            international partners.
[sbull] Habitat conservation'a network of lands and waters. Cooperating 
            with others, we strive to conserve an ecologically diverse 
            network of lands and waters of various ownership that 
            provide habitat 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. Our 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. We provide opportunities to the 
            public to enjoy, understand, and participate in the use and 
            conservation of fish and wildlife resources. The Service 
            directs activities on national wildlife refuges and 
            national fish hatcheries that increase opportunities for 
            public involvement with fish and wildlife resources. Such 
            opportunities include hunting, fishing, wildlife 
            observation and photography, and environmental education 
            and interpretation, as well as hands-on experiences through 
            volunteer conservation activities on Service lands.
[sbull] Partnerships in natural resources. We support and strengthen 
            partnerships with tribal, State, and local governments and 
            others in their efforts to conserve and enjoy fish, 
            wildlife, and plants and habitats. We administer Federal 
            grants to States and territories for restoration of fish 
            and wildlife resources and have a continuing commitment to 
            work with tribal governments. We also promote partnerships 
            with other Federal agencies where common goals can be 
            developed.
 The Service carries out these mission goals through several types of 
regulations. 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 while carrying out our responsibility to protect the natural 
resources entrusted to our care. In carrying out our assistance 
programs, we administer regulations to help interested parties obtain 
Federal assistance and then comply with applicable laws and Federal 
requirements. 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.
 We enforce regulations that govern public access, use, and recreation 
on 540 national wildlife refuges and in national fish hatcheries. We 
authorize

[[Page 72511]]

only 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 and recreational 
opportunity.
 We administer regulations to manage migratory bird resources. 
Annually, the Service issues a regulation on migratory bird hunting 
seasons and bag limits that is developed in partnership with the 
States, tribal governments, and the Canadian Wildlife Service. These 
regulations are necessary to permit migratory bird hunting that would 
otherwise be prohibited by various international treaties.
 We also implement regulations to fulfill our statutory obligation to 
identify and conserve species faced with extinction under the 
Endangered Species Act (ESA), and to conserve certain mammals under the 
Marine Mammal Protection Act. The basis for determining endangered and 
threatened species under the ESA is limited to biological 
considerations. Regulations enhance the conservation of ESA-listed 
species and help other Federal agencies comply with the ESA. Under 
section 7 of the ESA, all Federal agencies must consult with the 
Service on actions that may jeopardize their continued existence or 
result in the destruction or adverse modification of their critical 
habitats. In designating critical habitat for listed species, 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. The Department is 
currently reviewing guidance for designation of critical habitat. The 
guidance will provide policy direction and a process for developing 
critical habitat designations. The intent is that this guidance be used 
in the field for 6 months to ensure that it provides the outcome 
intended. If the field testing is successful, we anticipate developing 
a rule to put the guidelines in place permanently.
 In support of the President's Healthy Forests Initiative, the Service 
and the National Marine Fisheries Service are proposing counterpart 
regulations that will provide for an alternative consultation process 
under section 7 of the ESA for those projects that support the National 
Fire Plan (NFP). These proposed counterpart regulations should 
significantly accelerate planning, review, and implementation of NFP 
actions, and by doing so, should contribute to achieving the habitat 
management and ecosystem restoration activities contemplated in the 
NFP. These proposed regulations will be equally protective of listed 
species as the current process because the standards for determining 
adverse effects remain unchanged.
 We are also working with the Environmental Protection Agency and the 
National Oceanic and Atmospheric Administration on counterpart 
consultation regulations for ESA Section 7 consultations on pesticide 
registrations. Currently, EPA registers pesticides through a lengthy 
process that considers a number of environmental factors. The volume of 
registrations and reregistrations and the fact that the EPA 
registration process differs significantly from most of the Service's 
usual consultations require that we develop a particular process that 
addresses the special circumstance of these agency actions. An advance 
notice of proposed rulemaking was published in the Federal Register on 
January 24, 2003 (68 FR 3785) on this issue.
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 388 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 NPS 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 NPS also administers the following programs: the State portion of 
the Land and Water Conservation Fund; Federal Lands to Parks; 
nationwide outdoor recreation coordination and information, and State 
Comprehensive Outdoor Recreation Planning; Rivers, Trails and 
Conservation Assistance; National Trails System; Hydropower Recreation 
Assistance; National Register of Historic Places; National Historic 
Landmarks; National Natural Landmarks; American Battlefield Protection; 
National Maritime Heritage Grants; Native American Graves Protection 
and Repatriation; Tribal Heritage Preservation Grants; Technical 
Preservation Services; Historic American Buildings Survey; Historic 
American Engineering Record; Historic American Landscapes Survey; and 
Interagency Archeological Services.
 The NPS's regulatory activities focus on management of the National 
Park System and management of the programs assigned to it by Congress 
(and listed in the previous paragraph). Park-related regulations are 
designed to protect park resources while encouraging appropriate uses 
of the parks, consistent with each park's mission. Those regulations 
help ensure safe and sustainable public use, access, and recreation in 
the parks. Program-related regulations establish the procedures and 
standards by which the NPS will implement its legislated program 
responsibilities regarding, for example, the National Register Program 
and the Native American Graves Protection and Repatriation Act. The NPS 
regulatory program develops and reviews regulations for consistency 
with statutory law, current Administration priorities, and Service-wide 
policies.
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.

[[Page 72512]]

 Reclamation's regulatory program is designed to ensure that its 
mission is carried out expeditiously, efficiently, and with an emphasis 
on cooperative problemsolving.
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.
_______________________________________________________________________
DOI--United States Fish and Wildlife Service (FWS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

72. ENDANGERED SPECIES AND PESTICIDE REGULATION
Priority:


Other Significant


Legal Authority:


16 USC 1531 et seq


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


This proposed rulemaking announces the intention of the U.S. Fish and 
Wildlife Service, National Marine Fisheries Service, and the U.S. 
Environmental Protection Agency to conduct rulemaking to promulgate 
``counterpart regulations'' under the Endangered Species Act (ESA) for 
completing ESA section 7 consultation on EPA pesticide registration 
actions.


Statement of Need:


We are working with the Environmental Protection Agency and the 
National Oceanic and Atmospheric Administration on counterpart 
consultation regulations for ESA section 7 consultations on pesticide 
registrations. Currently, EPA registers pesticides through a lengthy 
process that considers a number of environmental factors. The volume of 
registrations and reregistrations and the fact that the EPA 
registration process differs significantly from most of the Service's 
usual consultations requires that we develop a particular process that 
addresses the special circumstance of these agency actions. An advance 
notice of rulemaking was published in the Federal Register on January 
24, 2003 (68 FR 3785) on this issue.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           68 FR 3786                                     01/24/03
NPRM                                                           11/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal


Federalism:


 Undetermined


Agency Contact:
Richard E Sayers Jr.
Chief, Branch of Consultation and Habitat Conservation Planning
Department of the Interior
United States Fish and Wildlife Service
ARLSQ-420
1849 C Street NW
Mailstop ARL-SQ 420
Washington, DC 20240
Phone: 703 358-2106
Fax: 703 358-1735
Email: [email protected]
RIN: 1018-AI95
_______________________________________________________________________
DOI--National Park Service (NPS)

                              -----------

                            FINAL RULE STAGE

                              -----------

73. SNOWMOBILE REGULATIONS FOR YELLOWSTONE AND GRAND TETON NATIONAL 
PARKS AND JDR PARKWAY
Priority:


Other Significant


Legal Authority:


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


CFR Citation:


36 CFR 7.13; 36 CFR 7.21; 36 CFR 7.22


Legal Deadline:


Final, Judicial, December 15, 2003, Final.


The NPS entered into a Settlement Agreement with the International 
Snowmobile Manufacturers Association and others in June 2001. The 
agreement was a result of a lawsuit initiated by ISMA disputing 
provisions of snowmobile regulations issued at the end of the Clinton 
Administration. The agreement has been amended and final regulations 
are required by December 15, 2003.


Abstract:


This is the final phase of a series of regulations modifying the use 
restrictions for snowmobiles and snowcoaches in Yellowstone and Grand 
Teton National Parks. This regulation, when published as a final rule, 
will implement new provisions for snowmobile and snowcoach management 
that arose from the Record of Decision signed March 25, 2003. The NPS 
will be working to have the final rule in effect before the start of 
the 2003-2004 winter use season.


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 analyze 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

[[Page 72513]]

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. That settlement 
agreement was amended and final regulations are now required by 
December 15, 2003.


Alternatives:


The only alternative to these regulations would be to allow provisions 
of the existing regulations for the parks go into effect for the winter 
use season 2003-2004. 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. Those snowmobiles would not be required to be cleaner or 
quieter.


Anticipated Cost and Benefits:


For the purposes of the benefit-cost analysis, the 2002 ``delay rule'' 
(alternative 1b in the SEIS) represents the baseline against which 
other alternatives were compared. Under this baseline, most snowmobile 
use would be prohibited in the parks as of the winter of 2004-2005, 
with restrictions on snowmobile use phased in during the winter of 
2003-2004. Alternatives 2-4 should provide greater economic benefits to 
snowmobile riders and businesses that support them since they are less 
restrictive relative to the baseline. The primary group that would 
incur costs under alternatives 2-4 would be the park visitors who do 
not ride snowmobiles and the businesses that provide services to these 
visitors as well as members of the general public who place a value on 
protecting park resources from the negative externalities associated 
with snowmobile use. Of the alternatives that allow for snowmobile use, 
alternative 3 is expected to impose the lowest cost on non-snowmobile 
users. Alternative 4 is expected to impose only slightly higher costs 
on non-snowmobile users than alternative 3.


Risks:


If the rulemaking were not to proceed, the gateway communities 
surrounding Yellowstone and Grand Teton National Parks would experience 
a decrease in snowmobile use by 50 percent beginning during the winter 
use season 2003-2004. Allowing the existing regulations to become 
effective would cause adverse economic impacts to the local communities 
and surrounding three-State area.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 51526                                    08/27/03
NPRM Comment Period End                                        10/14/03
Final Action                                                   12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Kym A. Hall
Regulations Program Manager
Department of the Interior
National Park Service
1849 C Street NW.
Washington, DC 20240
Phone: 202 208-4206
Fax: 202 208-4684
Email: [email protected]
RIN: 1024-AD11
_______________________________________________________________________
DOI--Minerals Management Service (MMS)

                              -----------

                            FINAL RULE STAGE

                              -----------

74. 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 ``nonproducing'' leases 
in the Gulf of Mexico west of 87 degrees, 30 minutes West longitude. It 
gives the Secretary of the Interior the authority to (1) promote 
development or increased production on producing and nonproducing 
leases, or (2) encourage production of marginal resources on producing 
and nonproducing 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

[[Page 72514]]

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.


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            68 FR 14867                                    03/26/03
NPRM Comment Period End                                        05/27/03
Final Action                                                   11/00/03
Regulatory Flexibility Analysis Required:


Yes


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
BILLING CODE 4310-RK-S

[[Page 72515]]

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.
 On March 1, 2003, pursuant to the Homeland Security Act of 2002 (HSA), 
the responsibility for providing immigration-related services and 
benefits such as naturalization and work authorization was transferred 
from the Justice Department's Immigration and Naturalization Service 
(INS) to the Bureau of Citizenship and Immigration Services (BCIS) in 
the Department of Homeland Security (DHS). The Attorney General has a 
continuing role in supervising removal and bond cases (conducted by the 
immigration judges and the Board of Immigration Appeals in the 
Executive Office for Immigration Review (EOIR)), as well as civil 
litigation and criminal prosecutions relating to the immigration laws.
 The Department of Justice's regulatory priorities focus in particular 
on two regulatory initiatives in the areas of civil rights. However, in 
addition to these 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 anti-terrorism and law 
enforcement priorities.
Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF)
 The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) issues 
regulations to enforce the Federal laws relating to the manufacture and 
commerce of firearms and explosives. ATF's mission 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 firearms and explosives industries, including 
            systems for licenses and permits;
[sbull] Assure the collection of all National Firearms Act (NFA) 
            firearms taxes and obtain a high level of voluntary 
            compliance with all laws governing the firearms industry; 
            and
[sbull] Assist the States in their efforts to eliminate interstate 
            trafficking in, and the sale and distribution of, 
            cigarettes and alcohol in avoidance of Federal and State 
            taxes.
 ATF will continue, as a priority during fiscal year 2004, 
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 final regulations implementing the provisions of the Safe 
Explosives Act, title XI, subtitle C, of Public Law 107-296, the 
Homeland Security Act of 2002 (enacted November 25, 2002).
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. 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 
and the Methamphetamine Anti-Proliferation Act of 2000, which regulate 
certain drug products that are being diverted for the production of 
methamphetamine.
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 revise 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

[[Page 72516]]

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 revised ADA Accessibility Guidelines as the ADA 
Standards for Accessible Design when the revised guidelines have been 
published in final form.
 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 
discrete 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 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.
Office of Justice Programs
 The Office of Justice Programs is developing International Terrorism 
Victim Compensation Program regulations (RIN 1121-AA63 to implement the 
International Terrorism Victim Compensation Program. This program is 
contained in the Victims of Trafficking and Violence Protection Act of 
2000 (Pub. L. 104-208), which directs the Office of Victims of Crime 
Director to compensate victims of acts of international terrorism that 
occur outside the United States for expenses associated with that 
victimization.
Regulations Published or Being Developed Because of September 11, 2001
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.
Executive Office for Immigration Review
[sbull] RIN 1125-AA47 (formerly, 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.
_______________________________________________________________________
DOJ--Civil Rights Division (CRT)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

75. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN PUBLIC 
ACCOMMODATIONS AND COMMERCIAL FACILITIES
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

[[Page 72517]]

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, 
and an Availability of Draft Final Guidelines on April 2, 2002. 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. The second 
stage 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.


As part of its November 1999 NPRM, the Access Board published a summary 
of the regulatory assessment that it had prepared, including a cost 
impact analysis and a discussion of regulatory alternatives considered. 
The Access Board will prepare and publish in summary form an updated 
regulatory assessment to accompany the final revised ADAAG. The Access 
Board's regulatory assessment will also apply to the Department's 
proposed adoption of revised ADAAG as ADA standards insofar as the 
standards apply to new construction and alteration. The Department will 
also prepare an additional regulatory assessment of the estimated 
annual cost of compliance with the revised standards with regard to 
existing facilities.


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                                                           06/00/04
NPRM Comment Period End                                        08/00/04
Regulatory Flexibility Analysis Required:


Yes


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
Phone: 800 514-0301
TDD Phone: 800 514-0383
Fax: 202 307-1198
RIN: 1190-AA44
_______________________________________________________________________
DOJ--CRT
76. NONDISCRIMINATION ON THE BASIS OF DISABILITY IN STATE AND LOCAL 
GOVERNMENT SERVICES
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

[[Page 72518]]

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 Access Board published an 
Availability of Draft Final Guidelines on April 2, 2002. 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 
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.


As part of its November 1999 NPRM, the Access Board published a summary 
of the regulatory assessment that it had prepared, including a cost 
impact analysis and a discussion of regulatory alternatives considered. 
The Access Board will prepare and publish in summary form an updated 
regulatory assessment to accompany the final revised ADAAG. The Access 
Board's regulatory assessment will also apply to the Department's 
proposed adoption of revised ADAAG as ADA standards insofar as the 
standards apply to new construction and alteration. The Department will 
also prepare an additional regulatory assessment of the estimated 
annual cost of compliance with the revised standards with regard to 
existing facilities.


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                                                           06/00/04
NPRM Comment Period End                                        08/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


Local, State

[[Page 72519]]

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
Phone: 800 514-0301
TDD Phone: 800 514-0383
Fax: 202 307-1198
RIN: 1190-AA46
BILLING CODE 4410-BP-S

[[Page 72520]]

DEPARTMENT OF LABOR (DOL)
2003 Regulatory Plan
Executive Summary: Protecting America's Workers
Since its creation in 1913, the Department of Labor has been guided by 
the idea that workers deserve safe and healthy workspaces, as well as 
protection of their wages and pensions. Protecting America's workers is 
a top priority of the Secretary of Labor. The Department works to 
enforce laws and regulations to ensure the health and safety of the 
American workforce. The vast majority of employers work hard to keep 
their employees and workplaces safe and secure. The Department is 
committed to aggressively enforcing the laws which protect employees. 
DOL also strives to provide employers with the knowledge and tools they 
need to carry out their legal obligations. The Secretary has made 
protecting workers through the coupling of compliance assistance and 
tough enforcement 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.
Compliance assistance works to prevent injuries before they occur. 
Educating and encouraging employers helps 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 
workers need constant updating of skills to compete in a changing 
marketplace. DOL helps employers and workers bridge the gap between the 
requirements of new high-technology jobs and the skills of the workers 
who are needed to fill them. Workers also need information about 
protection of their health insurance and pension benefits. The rights 
of workers returning to their jobs after military service must also be 
protected.
The Secretary of Labor's Regulatory Plan for Accomplishing These 
Objectives
In general, DOL tries to help employees and employers meet their needs 
in a cooperative fashion. DOL will maintain health and safety standards 
and protect employees working with the regulated community.
DOL considers the following proposals to be proactive, common sense 
approaches to the issues most clearly needing regulatory attention.
The Department's Regulatory Priorities
DOL has identified 19 high priority items for regulatory action. Seven 
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 is committed to ensuring safer and healthier 
workplaces for the nation's miners in a number of ways, and will 
continue to concentrate on improving existing health standards and 
addressing emerging health hazards in mining.
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 early in 
2002 to allow early participation by interested parties in the 
rulemaking. MSHA will continue to evaluate those comments as it 
prepares a notice of proposed rulemaking.
MSHA also continues its rulemaking on Diesel Particulate Matter 
Exposure of Underground Metal and Nonmetal Miners (RIN 1219-AB29). A 
proposed rule was published in August 2003. MSHA will address several 
provisions of the final standard, including changing the diesel 
particulate matter surrogate from total carbon to elemental carbon 
establishing the hierarchy of controls that MSHA applies to metal and 
nonmetal mines pursuant to its enforcement policy for exposure-based 
health standards, and addressing the diesel particulate matter control 
plan.
The comment period for MSHA's two coal mine dust rules (AB14 and AB18) 
has been extended in order to obtain information and data on personal 
dust monitors, a potentially promising technology currently being 
tested by NIOSH. These proposed rules will remain on the regulatory 
agenda. MSHA will be collaborating with NIOSH, miners' representatives, 
industry, and manufacturers in the in-mine testing of personal dust 
monitors. The results of this collaborative effort will guide MSHA in 
determining how to use these devices and the need for revisions to the 
coal mine dust sampling requirements.
The Occupational Safety and Health Administration oversees a wide range 
of measures in the public and private sectors. OSHA is committed to 
establishing clear and sensible priorities, and to continuing to reduce 
occupational deaths, injuries, and illnesses.
Four of OSHA's high-priority initiatives address health standards. The 
first, 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 and will make it easier for 
employers to choose the appropriate respirator for a given task. OSHA 
published an NPRM on June 6, 2003, and has scheduled an informal public 
hearing to begin on January 28, 2004.
OSHA's second initiative in the area of health standards addresses 
worker exposures to crystalline silica (RIN 1218-AB70). This substance 
is one of the most widely found in workplaces, and data indicate that 
exposure to it may cause silicosis, a debilitating respiratory disease, 
and perhaps cancer as well. OSHA is currently obtaining input from 
small businesses about regulatory approaches through a Small Business 
Regulatory Enforcement Fairness Act (SBREFA) panel. This rule was 
discussed in the 2002 OMB Report to Congress on the Costs and Benefits 
of Regulations.
OSHA's third health initiative addresses worker exposure to hexavalent 
chromium (RIN 1218-AB45). Approximately one million workers are exposed 
to this substance in general industry, maritime, construction and 
agriculture. Exposure to hexavalent chromium is associated with lung 
cancer and dermatoses. OSHA intends to initiate the SBREFA panel 
process in January 2004. This standard was discussed in OMB's 2002 
Report to Congress on the Costs and Benefits of Regulation.
The fourth health initiative, OSHA's Standards Improvement Project, 
will streamline a number of health standards by removing language that 
is outdated, duplicative, unnecessary or inconsistent (RIN 1218-AB81). 
These changes will reduce the time and effort needed to understand and 
comply with these standards. An NPRM was published October 31, 2002. A 
hearing was held in July 2003, and OSHA is currently preparing its 
final rule.

[[Page 72521]]

OSHA also has an initiative in the area of safety standards, Fire 
Protection in Shipyard Employment (RIN 1218-AB51). An NPRM was 
published on December 12, 2002, and a final rule is currently being 
prepared. This rule will provide a comprehensive approach to dealing 
with fires in shipyard environments to help prevent deaths and 
injuries.
Protection of pension and health benefits continues to be a priority of 
the Secretary. She has played a role in strengthening the retirement 
security of workers by supporting enhanced disclosure of their pension 
rights, increased freedom for workers to diversify their retirement 
savings, expanded access to investment advice, advance notice of 401(k) 
plan blackout periods, and restrictions on insider trading of employer 
stock during blackout periods. The last two proposals were enacted as 
part of the Sarbanes-Oxley Act of 2002. DOL adopted regulations 
implementing the blackout notice changes to the Employee Retirement 
Income Security Act (ERISA) in January 2003.
Consistent with the Secretary's priorities for FY 2004, the Employee 
Benefits Security Administration (EBSA) will focus on compliance 
assistance for pension and group health plans. Specific initiatives for 
group health plans include regulations concerning the application of 
the COBRA continuation of coverage notice provisions (RIN 1210-AA60); 
HIPAA access, portability and renewability provisions (RIN 1210-AA54); 
and HIPAA nondiscrimination provisions of ERISA (RIN 1210-AA77). With 
respect to pension plans, the Department will focus on the development 
of standards to facilitate the payment of benefits from 401(k) and 
other defined contribution plans that have been abandoned by their 
sponsors (RIN 1210-AA97).
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 plan of the Employment and Training 
Administration (ETA) to 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; more rapid 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 the community service 
employment program 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 re-engineer 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 effectiveness of the program; and better serve the 
Department of Labor's customers. This rule was discussed in the 2002 
OMB Report to Congress on the Costs and Benefits of Regulations.
The Employment Standards Administration (ESA) has set forth four 
priority regulatory initiatives. ESA's first initiative updates the 
child labor rules issued under the Fair Labor Standards Act (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 a high-quality education, and the assurance that 
their work hours are reasonable will help them in doing so.
ESA'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 discussed in 
OMB's 2001 and 2002 Reports to Congress on the Costs and Benefits of 
Regulations. An NPRM was published on March 31, 2003. In developing 
proposed changes, ESA is carefully examining the issues raised by 
various interested parties. Changes to these rules will help employers 
meet their obligations and will enhance workers' understanding of their 
rights and benefits.
ESA's third initiative pertains to regulations issued under the Family 
and Medical Leave Act (FMLA) that were also discussed in OMB's 2001 and 
2002 Reports to Congress on the 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.
ESA's fourth initiative involves programs administered by its Office of 
Labor-Management Standards (OLMS). The statutes administered by OLMS 
require labor organizations in the private sector and the Federal 
sector to file annual financial reports with the Department.` OLMS' 
initiative proposes revising the reporting forms (Forms LM-2, LM-3, and 
LM-4) and the creation of a new Form T-1 for trusts involving labor 
organizations in order to improve the transparency and accountability 
of labor organizations to their members, the public, and the 
government.' An NPRM was published on December 27, 2002 (RIN 1215-
AB34).
Finally, the Secretary's commitment to protecting the employment rights 
of servicemembers as they return to the civilian workforce is reflected 
by the Veterans' Employment and Training Service's initiative to 
promulgate regulations implementing the Uniformed Services Employment 
and Reemployment Rights Act of 1994 (USERRA). USERRA provides 
employment and reemployment protections for members of the uniformed 
services, including veterans and members of the Reserve and National 
Guard. The Department has not previously issued implementing 
regulations under USERRA. Authoritative written guidance interpreting 
USERRA will ensure that our servicemembers serve secure in the 
knowledge that they will be able to return to their jobs with the same 
pay, benefits, and status they would have attained had they not been 
away on military duty.

[[Page 72522]]

_______________________________________________________________________
DOL--Employment Standards Administration (ESA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

77. 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.


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                                                           06/00/04
NPRM Comment Period End                                        08/00/04
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: 202 693-1303
RIN: 1215-AB35
_______________________________________________________________________
DOL--ESA

                              -----------

                            FINAL RULE STAGE

                              -----------

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


Other Significant


Legal Authority:


29 USC 203(l)


CFR Citation:


29 CFR 570


Legal Deadline:


None


Abstract:


Section 3(l) of the Fair Labor Standards Act requires the Secretary of 
Labor to issue regulations with respect to minors between 14 and 16 
years of age ensuring that the periods and conditions of their 
employment do not interfere with their schooling, health, or well-
being. The Secretary is also directed to designate occupations that are 
particularly hazardous for minors 16 and 17 years of age. Child Labor 
Regulation No. 3 sets forth the permissible industries and occupations 
in which 14- and 15-year-olds may be employed, and specifies the number 
of hours in a day and in a week, and time periods within a day, that 
such minors may be employed. The Department has invited public comment 
in considering whether changes in technology in the workplace and job 
content over the years require new hazardous occupation orders, and 
whether changes are needed in some of the applicable hazardous 
occupation orders. Comment has also been solicited on whether revisions 
should be considered in the permissible hours and time-of-day standards 
for 14- and 15-year-olds. Comment has been sought on appropriate 
changes required to implement school-to-work transition

[[Page 72523]]

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.


The Department will also be considering what additional revisions to 
the hazardous occupation orders will be undertaken to address 
recommendations of the National Institute for Occupational Safety and 
Health in its May 2002 report to the Department.


Summary of Legal Basis:


These regulations are issued under sections 3(l), 11, 12, and 13 of the 
Fair Labor Standards Act, 29 U.S.C. 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.


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                                                   02/00/04
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: 202 693-1303
RIN: 1215-AA09
_______________________________________________________________________
DOL--ESA
79. 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

[[Page 72524]]

Abstract:


These regulations set forth the criteria for exemption from the Fair 
Labor Standards Act's minimum wage and overtime requirements 
``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 6.5 times the applicable minimum wage. Also, 
in 1992 the Department issued a final rule which modified the 
exemption's requirement for payment on a ``salary basis'' for otherwise 
exempt public sector employees.


Statement of Need:


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


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


Summary of Legal Basis:


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


Alternatives:


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


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


Anticipated Cost and Benefits:


Some 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            68 FR 15560                                    03/31/03
NPRM Comment Period End                                        06/30/03
Final Action                                                   03/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, Local, State


Federalism:


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

[[Page 72525]]

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: 202 693-1303
RIN: 1215-AA14
_______________________________________________________________________
DOL--Employment and Training Administration (ETA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

80. TRADE ADJUSTMENT ASSISTANCE FOR WORKERS
Priority:


Other Significant


Legal Authority:


19 USC 2320; Secretary's Order No. 3-81, 46 FR 31117


CFR Citation:


29 CFR 90; 20 CFR 617; 20 CFR 618; 20 CFR 666; 20 CFR 672; . . .


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.


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 create a new 20 CFR part 
618 to incorporate the amendments and be written in plain English, 
while amending WIA regs at 20 CFR parts 666 and 672 regarding Rapid 
Response and National Emergency Grants as they relate to the TAA 
program.


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, 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                                                           04/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


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

                              -----------

                            FINAL RULE STAGE

                              -----------

81. 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.

[[Page 72526]]

Statement of Need:


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


Summary of Legal Basis:


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


Alternatives:


Regulatory alternatives are now being developed by the Department. The 
public was afforded an opportunity to comment on the Department's plans 
for streamlining the permanent labor certification process in a notice 
of proposed rulemaking which was published in the Federal Register on 
May 6, 2002.


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 Action                                                   11/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal, State


Agency Contact:
William Carlson
Chief, Division of Foreign Labor Certification
Department of Labor
Employment and Training Administration
200 Constitution Avenue NW.
Room C4318 FP Building
Washington, DC 20210
Phone: 202 693-3989
Fax: 202 693-2760
Email: [email protected]
RIN: 1205-AA66
_______________________________________________________________________
DOL-ETA
82. 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            68 FR 22520                                    04/28/03
NPRM Comment Period End                                        06/12/03
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal

[[Page 72527]]

Federalism:


 Undetermined


Agency Contact:
Ria Moore Benedict
Programs
Department of Labor
Employment and Training Administration
200 Constitution Avenue NW.
FP Building, Room N5306
Washington, DC 20210
Phone: 202 693-3198
Fax: 202 693-3817
Email: [email protected]
RIN: 1205-AB28
_______________________________________________________________________
DOL--Employee Benefits Security Administration (EBSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

83. [bull] RULEMAKING RELATING TO TERMINATION OF ABANDONED INDIVIDUAL 
ACCOUNT PLANS
Priority:


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


Legal Authority:


29 USC 1135


CFR Citation:


29 CFR 2591


Legal Deadline:


None


Abstract:


This rulemaking will establish a procedure and standards for 
distributing the benefits of individual account plans that have been 
abandoned by their sponsoring employers or plan administrators.


Statement of Need:


Thousands of individual account plans have, for a variety of reasons, 
been abandond by their sponsors, creating problems for plan 
participants, administrators, financial institutions (e.g., banks, 
insurance companies, mutual funds), the courts and the Federal 
government. At present, the potential liability and costs attendant to 
terminating such plans and distributing the assets inhibits financial 
institutions and others from taking on this responsibility. Due to on-
going administrative costs and other factors, the continued maintenance 
of such plans is often not in the interest of the participants and 
beneficiaries. This rulemaking will establish a procedure for a 
financial institution that holds the assets of such a plan to terminate 
the plan and distribute its assets to the participants and 
beneficiaries. The rulemaking will also include standards for 
determining when plans may be terminated pursuant to this procedure and 
for carrying out the functions necessay to distribute benefits and shut 
down plan operation.


Summary of Legal Basis:


Section 505 of ERISA provides that the Secretary may prescribe such 
regulations as the Secretary finds necessary and appropriate to 
carryout the provisions of Title I of the Act. Section 403(d)(1) 
provides that, upon termination of such a plan, the assets shall be 
distributed generally in accordance with the provisions that apply to 
defined benefit plans, ``except as otherwise provided in regulations of 
the Secretary.'' ERISA section 3(16)(A) permits the Secretary to issue 
regulations designating an administrator for a plan where the plan 
document makes no designation and the plan sponsor cannot be 
identified. ERISA section 110 to establish an alternate means of 
compliance with ERISA's reporting and disclosure provisions.


Alternatives:


Alternatives will be considered following a determination of the scope 
and nature of the regulatory guidance needed by the public.


Anticipated Cost and Benefits:


Preliminary estimates of the anticipated costs and benefits will be 
developed, as appropriate, following a determination regarding the 
alternatives to be considered.


Risks:


Failure to provide guidance in this area will leave the retirement 
benefits of participants and beneficiaries in abandoned plans at risk 
of being significantly diminished by ongoing plan administrative 
expenses, rather than distributed to participants and beneficiaries in 
connection with a timely and orderly termination of the plan.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Agency Contact:
Jeffrey Turner
Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
N 5669
200 Constitution Avenue NW
Room N5669
FP Building
Washington, DC 20210
Phone: 202 693-8500
RIN: 1210-AA97
_______________________________________________________________________
DOL--EBSA

                              -----------

                            FINAL RULE STAGE

                              -----------

84. 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, Other.


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

[[Page 72528]]

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.


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                                                     02/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Amy Turner
Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
Room N5677
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8335
RIN: 1210-AA54
_______________________________________________________________________
DOL--EBSA
85. 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            68 FR 31832                                    05/28/03
NPRM Comment Period End                                        07/28/03
Final Action                                                   03/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


None


Agency Contact:
Susan G. Lahne
Senior Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
Room N5669
200 Constitution Avenue NW.
FP Building
Washington, DC 20210
Phone: 202 693-8500
RIN: 1210-AA60
_______________________________________________________________________
DOL--EBSA
86. 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 1182; 29 USC 1191c; 29 
USC 1194


CFR Citation:


29 CFR 2590.702


Legal Deadline:


None


Abstract:


Section 702 of the Employee Retirement Income Security Act of

[[Page 72529]]

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 provides 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 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.


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


No


Government Levels Affected:


Undetermined


Additional Information:


This item has been split off from RIN 1210-AA54.


Agency Contact:
Amy Turner
Pension Law Specialist
Department of Labor
Employee Benefits Security Administration
Room N5677
200 Constitution Avenue NW
FP Building
Washington, DC 20210
Phone: 202 693-8335
RIN: 1210-AA77
_______________________________________________________________________
DOL--Mine Safety and Health Administration (MSHA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

87. 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. 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 in 1976 for coal mining (41 FR 10223) and 1978 
for metal and nonmetal mining (43 FR 54064). During 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 to an 8-hour time-weighted 
average limit of 0.1 fiber per cubic centimeter of air and the 
excursion limit 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.


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 Agency has increased sampling efforts in an attempt to determine

[[Page 72530]]

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. In early 
2000, MSHA began an intensive sampling effort at operations with 
potential asbestos exposure. These efforts continue. While sampling, 
MSHA staff discussed with 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 regulatory 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 asbestosis, mesothelioma, and other forms of cancers.


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                                                           05/00/04
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
Room 2350
Arlington, VA 22209
Phone: 202 693-9440
Fax: 202 693-9441
Email: [email protected]
RIN: 1219-AB24
_______________________________________________________________________
DOL--MSHA

                              -----------

                            FINAL RULE STAGE

                              -----------

88. 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 (66 FR 5706). 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. Industry 
challenged the rule and organized labor intervened in the litigation. 
Settlement negotiations with the litigants have resulted in further 
regulatory actions on several requirements of the rule. One final rule 
has been published (67 FR 9180). This new rulemaking will address the 
remaining issues. MSHA issued an ANPRM on September 25, 2002 to obtain 
additional information and to develop a proposed rule in 2003.


Statement of Need:


As a result of the first 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 tagging 
provisions of the maintenance standard; 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.


As a request of the second partial settlement agreement, MSHA also 
agreed to proposed specific changes to the 2001 DPM final rule. On 
September 25, 2002, MSHA published an Advance Notice of Proposed 
Rulemaking (ANPRM) (67 FR 60199). In response to commenters, MSHA 
intends at this time to propose changes only to the interim DPM 
standard of 400 micrograms per cubic meter of air. In a separate 
rulemaking, the Agency will propose a rule to revise the final 
concentration limit of 160 micrograms per cubic meter of air pursuant 
to the DPM settlement agreement. The scope of both rulemakings is 
limited to the settlement agreement. The current rulemaking addresses 
the following provisions:


 57.5060(a)--Propose to change the existing DPM surrogate from total 
carbon to elemental carbon; propose that a single personal sample of 
miner's exposure would be an adequate basis for MSHA compliance 
determinations; and propose the current hierarchy of controls that MSHA 
applies in its existing metal and nonmetal exposure based health 
standards for abating violations.


 57.5060(c)--Propose to adapt to the interim limit the existing 
provision that allows mine operators to apply to the Secretary for 
additional time to come into compliance with the final concentration 
limit. MSHA also agreed to propose to include consideration of economic 
feasibility, and to allow for annual renewals of such special 
extensions.


 57.5060(d)--This existing provision permits miners to engage in 
certain activities in concentrations exceeding the interim and final 
limits upon

[[Page 72531]]

application and approval from the Secretary. MSHA asked commenters if 
this provision should be removed since the Agency agreed to propose the 
existing hierarchy of controls.


 57.5060(e)--MSHA agreed to propose to remove the existing prohibition 
on the use of personal protective equipment.


 57.5060(f)--MSHA agreed to propose to remove the prohibition on the 
use of administrative controls.


 57.5061(b)--MSHA is proposing to change the reference from ``total 
carbon'' to ``elemental carbon.''


 57.5061(c)--MSHA is proposing to delete the references to ``area'' and 
``occupational'' sampling for compliance.


 57.5062--MSHA agreed to propose revisions to the existing diesel 
control plan.


Summary of Legal Basis:


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


Alternatives:


This rulemaking action is a result of the parties' settlement 
agreement. This action will not decrease protection for miners.


Anticipated Cost and Benefits:


MSHA's preliminary economic analysis indicates minimum costs to the 
mining industry.


Risks:


Several epidemiological studies have found that exposure to diesel 
exhaust presents potential health risk to the miners. These potential 
adverse health effects range from headaches and nausea to respiratory 
disease and cancer. In the confined space of the underground mining 
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 more effectively 
reduce miners exposure to DPM.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           67 FR 60199                                    09/25/02
ANPRM Comment Period End                                       11/25/02
NPRM            68 FR 48668                                    08/14/03
NPRM Comment Period End                                        10/14/03
Final Action                                                   03/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


None


Agency Contact:
Marvin W. Nichols Jr.
Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
1100 Wilson Boulevard, Room 2350
Arlington, VA 22209
Phone: 202 693-9440
Fax: 202 693-9441
Email: [email protected]
RIN: 1219-AB29
_______________________________________________________________________
DOL--Occupational Safety and Health Administration (OSHA)

                              -----------

                             PRERULE STAGE

                              -----------

89. OCCUPATIONAL EXPOSURE TO HEXAVALENT CHROMIUM (PREVENTING 
OCCUPATIONAL ILLNESS: CHROMIUM)
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


29 USC 655(b); 29 USC 657


CFR Citation:


29 CFR 1910


Legal Deadline:


NPRM, Judicial, October 4, 2004, NPRM.


Abstract:


In July 1993, the Occupational Safety and Health Administration (OSHA) 
was petitioned for an emergency temporary standard (ETS) to reduce the 
permissible exposure limit (PEL) for occupational exposures to 
hexavalent chromium (CrVI). The Oil, Chemical, and Atomic Workers 
International Unions (OCAW) and Public Citizen's Health research Group 
(HRG) petitioned OSHA to promulgate an ETS to lower the PEL for CrVI 
compounds to 0.5 micrograms per cubic meter of air (ug/mg3) as an 
eight-hour, time-weighted average (TWA). The current PEL in general 
industry is a ceiling value of 100 ug/m3, measured as CrVI and reported 
as chromic anhydride (CrO3). The amount of CrVI in the anhydride 
compound equates to a PEL of 52 ug/m3. The ceiling limit applies to all 
forms of CrVI, including chromic acid and chromates, lead chromate, and 
zinc chromate. The current PEL of CrVI in the construction industry is 
100 ug/m3 as a TWA PEL, which also equates to a 52 ug/m3. After 
reviewing the petition, OSHA denied the request for an ETS and 
initiated a section 6(b)(5) rulemaking.


OSHA began collecting data and performing preliminary analyses relevant 
to occupational exposure to CrVI. However, in 1997, OSHA was sued by 
HRG for unreasonable delay in issuing a final CrVI standard. The 3rd 
Circuit, U.S. Court of Appeals ruled in OSHA's favor and the Agency 
continued its data collection and analytic efforts on CrVI. In 2002, 
OSHA was sued again by HRG for continued unreasonable delay in issuing 
a final CrVI standard. In August, 2002 OSHA published a Request for 
Information on CrVI to solicit additional information on key issues 
related to controlling exposures to CrVI and on December 4, 2002 OSHA 
announced its intent to proceed with developing a proposed standard. On 
December 24, 2002, the 3rd Circuit, U.S. Court of Appeal ruled in favor 
of HRG and ordered the Agency to proceed expeditiously with a CrVI 
standard. A subsequent order from the court on April 2, 2003 
established an October 4, 2004 deadline for publication of a proposed 
standard and a January 18, 2006 deadline for publication of the final 
standard.


The major illnesses associated with occupational exposure to CrVI are 
lung cancer and dermatoses. OSHA estimates that approximately one 
million workers are exposed to CrVI on a regular basis in all 
industries. The major uses of CrVI are: as a structural and 
anticorrosive element in the production of stainless steel, 
ferrochromium, iron and steel, and in electroplating, welding and 
painting.


Statement of Need:


Approximately one million workers are exposed to CrVI in general 
industry, maritime, construction, and agriculture. Industries or work 
processes that could be particularly affected by a standard for CrVI 
include: Electroplating, welding, painting, chromate production, 
chromate pigment production, ferrochromium production,

[[Page 72532]]

iron and steel production, chromium catalyst production, and chromium 
dioxide and sulfate production. Exposure to CrVI has been shown to 
produce lung cancer, an often fatal disease, among workers exposed to 
CrVI compounds. The International Agency for Research on Cancer (IARC) 
classifies CrVI compounds as a Group 1 Carcinogen: Agents considered to 
be carcinogenic in humans. The Environmental Protection Agency (EPA) 
and the American Conference of Governmental Hygienists (ACGIH) have 
also designated CrVI compounds as known and confirmed human 
carcinogens, respectively. Similarly, the National Institute for 
Occupational Safety and Health (NIOSH) considers CrVI compounds to be 
potential occupational carcinogens. OSHA's current standards for CrVI 
compounds, adopted in 1971, were established to protect against nasal 
irritation. Therefore, there is a need to revise the current standard 
to protect workers from lung cancer.


Summary of Legal Basis:


The legal basis for the proposed rule is a preliminary determination 
that workers are exposed to a significant risk of lung cancer and 
dermatoses and that rulemaking is needed to substantially reduce the 
risk.


Alternatives:


OSHA had considered non-regulatory approaches, including the 
dissemination of guidance on its web site. However, OSHA has determined 
that rulemaking is a necessary step to ensure that workers are 
protected from the hazards of CrVI and the Agency has been ordered by 
the U.S. Court of Appeals to move forward with a final rule. 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 been developed.


Risks:


A detailed risk analysis has not yet been completed for this rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Request for Info67 FR 54389                                    08/22/02
Comment Period End                                             11/20/02
Initiate SBREFA Process                                        12/00/03
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Undetermined


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue, NW
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB45
_______________________________________________________________________
DOL--OSHA
90. 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 for Testing and Materials (ASTM) has published a recommended 
standard for addressing 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 analytical methods to ensure that employers and employees 
are receiving reliable data on 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. The Advisory Committee for Construction Safety and Health has 
also formed a silica working group to assist the Agency in addressing 
construction-related issues during the development of the proposed 
rule.


Statement of Need:


Over two 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 operations, 
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

[[Page 72533]]

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 of death. 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, as well as, renal and autoimmune 
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 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 rule will recognize that the PELs 
for construction 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 non-regulatory 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 and estimates of the costs and 
benefits are still under development.


Risks:


A detailed risk analysis has not yet been completed for this rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Complete SBREFA Report                                         01/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Undetermined


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue, NW
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB70
_______________________________________________________________________
DOL--OSHA

                              -----------

                            FINAL RULE STAGE

                              -----------

91. 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.


This rulemaking action will complete the 1998 standard, reduce 
compliance confusion among employers, and provide employees with 
consistent and appropriate respiratory protection. On June 6, 2003, 
OSHA published an NPRM on Assigned Protection Factors in the Federal 
Register at 68 FR 34036 containing a proposed APF table, and requesting 
public comment. The extended comment period ended October 2, 2003.


Statement of Need:


About five 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

[[Page 72534]]

enforcement, lack of guidance for employers, and the potential for 
inadequate employee protection.


Anticipated Cost and Benefits:


The estimated compliance costs for OSHA's proposed APF rule are $4.6 
million. The APFs proposed in this rulemaking help to ensure that the 
benefits attributed to proper respiratory protection under 29 CFR 
1910.134 are achieved, as well as provide an additional degree of 
protection.


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 has been 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            68 FR 34036                                    06/06/03
NPRM Comment Period End                                        09/04/03
Other/NPRM Comme68 FR 53311xtended                             10/02/03
Public Hearing o68 FR 640364                                   11/12/03
Final Rule: Revocation of Respiratory Protection M. TB         12/00/03
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


At the time of the revision of the 1972 standard, OSHA decided that 
because its proposed standard for occupational exposure to tuberculosis 
(TB), published three months earlier, included a comprehensive 
respiratory protection provision, the agency would allow compliance 
with the previous respirator standard for TB protection until 
completion of the TB rulemaking. Thus, pending conclusion of the TB 
rulemaking, OSHA redesignated the old respiratory protection standard 
in a new section entitled ``Respiratory Protection for M. 
Tuberculosis.`` Because OSHA has decided to withdraw its proposed TB 
standard, the agency is revoking the designated respiratory protection 
standard, and will begin applying the general industry respiratory 
protection standard (29 CFR 1910.134) to respiratory protection against 
TB.


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue, NW
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AA05
_______________________________________________________________________
DOL--OSHA
92. 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 published 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 work force. Updating OSHA's outdated shipyard 
requirements for fire extinguishers, sprinkler systems, detection 
systems, alarm systems, and fire brigades will facilitate compliance by 
employers and employees and reduce these fire-related injuries and 
fatalities.


Summary of Legal Basis:


The legal basis for this proposed rule is a preliminary determination 
that an unacceptable risk of fire-related injuries and fatalities 
exists in the shipyard industry.


Alternatives:


OSHA has considered but rejected the alternative of allowing the 
existing rule to remain in place, because the Agency believes that 
doing so would contribute to the unacceptable number of fire-related 
accidents occurring in shipyards every year.


Anticipated Cost and Benefits:


The Agency has estimated annual costs of the NPRM to be $4.3 million, 
and that there will be cost savings of $6.2 million, in addition to 
avoiding fatalities and injuries.


Risks:


The Agency has estimated that compliance with the NPRM would prevent 
one fatality and 102 lost workday injuries annually.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 76213                                    12/11/02
Comment Period End                                             03/11/03
Final Rule                                                     03/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Agency Contact:
Steven F. Witt
Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue, NW
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB51

[[Page 72535]]

_______________________________________________________________________
DOL--OSHA
93. 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 and health standards.


Statement of Need:


Some parts 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
NPRM Comment Per68 FR 1023ed                                   01/08/03
Second NPRM Comment Period End                                 01/30/03
Public Hearing                                                 07/08/03
Final Action                                                   02/00/04
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
200 Constitution Avenue, NW
Room N-3718, FP Building
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
RIN: 1218-AB81
_______________________________________________________________________
DOL--Office of the Assistant Secretary for Veterans' Employment & 
Training (ASVET)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

94. UNIFORMED SERVICES EMPLOYMENT AND REEMPLOYMENT RIGHTS ACT 
REGULATIONS
Priority:


Other Significant


Legal Authority:


38 USC 4331(a)


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


The Secretary's commitment to protecting the employment rights of 
servicemembers as they return to the civilian work force is reflected 
by the initiative to promulgate regulations implementing the Uniformed 
Services Employment and Reemployment Rights Act of 1994 (USERRA). 
USERRA provides employment and reemployment protections for members of 
the uniformed services, including veterans and members of the Reserve 
and National Guard. The Department has not previously issued 
implementing regulations under USERRA, albeit the law dates back to 
1994. Authoritative written guidance interpreting USERRA will ensure 
that our servicemembers serve secure in the knowledge that they will be 
able to return to their jobs with the same pay, benefits, and status 
they would have attained had they not been away on military duty.


Statement of Need:


The Uniformed Services Employment and Reemployment Rights Act of 1994 
(USERRA), 38 U.S.C. 4301-4333, provides employment and reemployment 
rights for members of the uniformed services, including veterans and 
members of the Reserve and National Guard. Under USERRA, service 
members who leave their civilian jobs for military service can perform 
their duties with the knowledge that they will be able to return to 
their jobs with the same pay, benefits, and status they would have 
attained had they not been away on duty. USERRA also assures that they 
will not suffer discrimination in

[[Page 72536]]

employment because of their military service.


The Department has not issued implementing regulations under USERRA. In 
the absence of regulations, VETS has engaged in significant compliance 
assistance efforts, including a Non-Technical Resource Guide to USERRA, 
briefings for service members and employers, a web-based elaws Advisor 
and other web-based aids such as FAQs, a toll-free help line for basic 
USERRA questions, and informal email responses to electronic inquiries. 
VETS has also issued about 40 memoranda interpreting issues that have 
arisen under USERRA. In addition, VETS has prepared a draft USERRA 
Handbook as part of its compliance assistance efforts. A copy of the 
draft Handbook is attached.


Approximately 300,000 members of the National Guard and Reserve have 
been called up since the President's declaration of a national 
emergency following the attacks of September 11, 2001. As service 
members conclude their tours of duty and return to civilian employment, 
it is important for employers to recognize that USERRA requires that 
returning veterans receive many important benefits of employment that 
they would have attained had they been continuously employed. It is 
also important for service members to know what their rights and 
responsibilities are under the law, and how the Department can assist 
them in enforcing these rights.


In the past year, the Department has experienced a tremendous increase 
in the number of inquiries from employers and members of the Reserves. 
The Department has responded to over 9,500 requests for technical 
assistance, and has provided USERRA briefings to nearly 50,000 persons, 
including members of the National Guard, Reserve and employer groups. 
These numbers are conservative, as not all instances of technical 
assistance have been documented. The volume of technical assistance 
requests indicates a strong public interest in authoritative written 
guidance from the Department. The complexity of the issues raised 
demonstrates the value of such guidance.


Another consideration is the possibility of the call to active duty of 
a large number of additional National Guard and Reserve members. The 
ongoing war on terrorism is widely expected to last for a significant 
period of time. Persons currently mobilized are serving for much longer 
periods of time than those who served in Desert Storm, thereby causing 
greater concerns among the Reserve and employer communities. Any 
escalation of the use of National Guard and Reserve personnel will 
cause a corresponding increase in the need for USERRA information among 
Reservists, employers and the public. Authoritative written USERRA 
guidance will ensure that the capability of VETS' staff to respond 
promptly is not exceeded and that the information provided is uniform 
and correct.


The high volume of requests for technical assistance received by the 
Department since September 2001 indicates that there is a significant 
need for authoritative USERRA guidance. USERRA regulations would 
provide authoritative guidance by codifying the Department's 
interpretations of the law and the Department's procedures for 
enforcing the law.


Summary of Legal Basis:


USERRA authorizes the Secretary of Labor, in consultation with the 
Secretary of Defense, to issue regulations implementing USERRA with 
regard to States, local governments and private employers. 38 U.S.C. 
4331(a).


Alternatives:


In lieu of regulations, the Department could choose to continue its 
compliance assistance efforts, and could issue interpretations of 
USERRA in the form of the USERRA Handbook, policy memoranda or other 
less formal means. These would not benefit from broad-based public 
input, nor would they receive the same level of deference as 
regulations. See United States v. Mead Corp., 533 U.S. 218, 230 (2001).


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


Undetermined


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, Local, State


Agency Contact:
Norman Lance
Chief, Investigation and Compliance Division
Department of Labor
Office of the Assistant Secretary for Veterans' Employment & Training
200 Constitution Avenue, NW
Room S-1316
Washington, DC 20210
Phone: 202 693-4721
Fax: 202 693-4755
Email: [email protected]
RIN: 1293-AA09
BILLING CODE 4510-23-S

[[Page 72537]]

DEPARTMENT OF TRANSPORTATION (DOT)
Statement of Regulatory Priorities
The Department of Transportation (DOT) consists of nine 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, 
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. 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, 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 
email notification when the Department issues a rulemaking document; 
creation of an electronic rulemaking tracking and coordination 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.
The Department 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.
One of the Department's primary efforts during the past year was to 
overhaul and expedite the rulemaking process and to move long-pending 
rulemaking projects to completion. To achieve these goals, the 
Department took a number of steps. For example, the Department created 
an effective tracking system for significant rulemakings to ensure that 
rules are either completed in a timely manner or that delays are 
identified and fixed. Through this tracking system, a monthly report is 
generated. To make its efforts more transparent, the Department has 
made this report internet-accessible. By doing this, the Department is 
providing valuable information concerning our rulemaking activity and 
is providing information necessary for the public to evaluate the 
Department's progress in meeting its commitment to completing 
rulemakings in a timely manner.
The Department also conducted a review of the current status of all 
rulemakings pending within the Department. This review helped to 
identify and resolve problems with delay of older rulemakings, and has 
resulted in a significant increase in our rulemaking productivity. 
Furthermore, in a concerted effort to ``clean up'' the Department's 
Regulatory Agenda, we also identified a number of proceedings for which 
no action had been taken in a number of years. Those proceedings for 
which no further action was contemplated were withdrawn or terminated 
in a July 2003 notice published in the Federal Register.
The Department will continue to place great emphasis on the need to 
complete high quality rulemakings by involving senior Departmental 
officials in regular meetings to resolve issues expeditiously.
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 assessments, 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 2004, OST expects to complete work on a final rule 
on

[[Page 72538]]

Computer Reservation Systems. 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 these reporting requirements during FY 2004.
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 initial result of this 
review was revisions to 14 CFR part 11, which delineates the process 
for rulemaking changes. We have extended this initiative to include 
plain language revisions to our regulatory documents, advisory 
material, handbook guidance, and all reports and correspondence we 
prepare. Other actions include:
Supporting the FAA's Safety Agenda on Safer Skies. This agenda is based 
on a comprehensive review of the causes of aviation accidents and is 
designed to bring about a five-fold(80 percent) reduction in fatal 
accidents. Projects related to controlled flight into terrain, loss of 
control of an aircraft, uncontained engine failures, runway incursions, 
weather, pilot decisionmaking, and cabin safety are some of the focus 
areas identified that may result in rulemaking advisory and guidance 
materials.
Continuing to involve the aviation community early in the regulatory 
process. The Aviation Rulemaking Advisory Committee completed numerous 
reports and recommendations, leading to the publication of seven 
regulatory actions and issuance of several advisory circulars and other 
guidance materials. The FAA Aging Transport Nonstructural Systems Plan 
addresses concerns with potential safety issues associated with 
problems that may develop in transport category airplanes systems as a 
result of wear and degradation in service. One important component of 
the plan is use of the Aging Transport Nonstructural Systems Rulemaking 
Advisory Committee to provide a mechanism for public input to FAA 
activities. The FAA will continue to receive recommendations from the 
Committee in the form of regulations, guidance materials, and training 
requirements supporting enhanced airworthiness for airplane systems.
Continuing to harmonize the U.S. aviation regulations with those of 
other countries. The harmonization of the U.S. regulations with the 
European Joint Aviation Regulations (JAR) is the FAA's most 
comprehensive long-term rulemaking effort. The differences worldwide in 
certification standards, practice 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 operations. 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 41 
regulations based on recommendations of ARAC that will lead to 
harmonizing FAA regulations and Joint Aviation Requirements.
Continuing to recognize the needs of small entities by complying with 
the Small Business Regulatory Enforcement Fairness Act and addressing 
small entity concerns whenever appropriate in rulemaking documents. In 
response the Act, the FAA has established a Small Entity Contact, a Web 
site on FAA's home page, a toll-free number, and an email address for 
receipt of inquiries.
Ensuring that the congressional mandates for rulemaking deadlines 
established by the FAA Reauthorization Act of 1996 are met. One mandate 
is the issuance of a final rule 16 months after the close of the 
comment period on the proposed rule.
Top regulatory priorities for 2003-2004 include final rules concerning 
certification of airports and flight simulation device requirements.
Federal Highway Administration (FHWA)
The FHWA anticipates that its priority for fiscal year 2004 will be the 
ongoing regulatory implementation of the Transportation Equity Act for 
the 21st Century, 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)
FMCSA commenced operations on January 2, 2000, pursuant to the Motor 
Carrier Safety Improvement Act of 1999 (MCSIA) (Public Law 106 
173;159), as codified at 49 U.S.C. 167; 113, to improve the 
administration of the Federal motor carrier safety program. The 
agency's primary mission is to reduce crashes, injuries, and fatalities 
involving large trucks and buses. Since its inception, FMCSA has 
developed a strong Safety Action Plan to guide it toward reducing the 
number of large truck- and bus-involved fatalities. DOT's safety goal 
for all its surface transportation agencies is to reduce the fatality 
rate by 41% during a period from 1996 to 2008. Although any life lost 
in a traffic crash is too many, FMCSA will strive to meet and exceed 
this safety goal. For example, regulations relating to performance 
standards for vehicles, drivers and motor carriers will help achieve 
this goal. In MCSIA, Congress put special emphasis on the importance of 
timely rulemaking as a way to achieve reductions in the number and 
severity of large truck-involved crashes. 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. To improve both the quality and timeliness of the 
agency's rulemakings, FMCSA established a rulemaking process for the 
development of its motor carrier safety regulations.
In fiscal year 2004, FMCSA must issue the following final rules 
pursuant to the settlement agreement entered into by the parties and 
the court's order in In re Citizens for Reliable and Safe Highways, et 
al., No. 02-1363 (D.C. Cir.) (February 21, 2003): Safety Performance 
History of New Drivers (03/2004); Minimum Training Requirements for 
Longer Combination Vehicle (LCV) Operators and LCV Driver-Instructor

[[Page 72539]]

Requirements (03/2004); Minimum Training Requirements for Entry-Level 
Commercial Motor Vehicle Operators 05/2004); and Hazardous Materials 
Safety Permits (06/2004). It also continues to expedite a number of 
other important rulemakings.
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 safety performance 
information to aid prospective purchasers of vehicles, child 
restraints, and tires; and improving automotive fuel efficiency. NHTSA 
pursues policies that encourage the development of nonregulatory 
approaches when feasible in meeting its statutory mandates. It issues 
new standards and regulations or amendments to existing standards and 
regulations when appropriate. It ensures that regulatory alternatives 
reflect a careful assessment of the problem and a comprehensive 
analysis of the benefits, costs, and other impacts associated with the 
proposed regulatory action. Finally, it considers alternatives 
consistent with the Administration's regulatory principles.
NHTSA has identified two high priority vehicle safety areas, vehicle 
compatibility and rollover mitigation, and released reports in 2003 
analyzing problems in each of those areas and describing actions to 
address them. An important regulatory priority, upgrading side impact 
protection, will aid efforts in both of these areas. Another regulatory 
priority for NHTSA is reforming the automobile fuel economy standards 
program (CAFE). In addition, NHTSA has published its plan for vehicle 
safety rulemaking priorities, NHTSA Vehicle Safety Rulemaking 
Priorities and Supporting Research: 2003-2006. The plan highlights the 
agency's priority rulemaking actions to help address the most 
significant vehicle safety needs.
 In addition to numerous programs that focus on the safe performance of 
motor vehicles, the Agency is engaged in a variety of programs to 
improve driver and occupant behavior. These programs emphasize the 
human aspects of motor vehicle safety and recognize the important role 
of the States in this common pursuit. NHTSA has identified two high 
priority areas, safety belt use and impaired driving. It released a 
report in 2003 analyzing safety belt use problems and describing 
actions to address them. A report addressing impaired driving is 
expected later this year. Other behavioral efforts include encouraging 
initiatives in such areas as child safety-seat use, activities aimed at 
combating aggressive driving, and consumer information activities.
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 
the consensus recommendations serve 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 review of FRA regulations 
for their applicability to historic railroads; 2) the development of 
safety standards for locomotive crashworthiness; 3) the development of 
safety standards for locomotive working conditions; 4) the development 
of locomotive event recorder accident survivability standards; 5) the 
development of regulations governing the use of processor-based signal 
and train control systems; 6) the revision of FRA's blue signal 
protection requirements for workers performing certain duties on, under 
or between rolling equipment; and 7) the revision of FRA's standards 
for the safety of cars used by railroad carriers to transport 
passengers.
Federal Transit Administration (FTA)
The Federal Transit Administration (FTA) provides financial assistance 
to State and local governments for mass transportation purposes. The 
regulatory activity of FTA focuses on establishing the terms and 
conditions of Federal financial assistance available under the Federal 
transit laws.
FTA's policy regarding regulations is to:
Implement statutory authorities in ways that provide the maximum net 
benefits to society;
Keep paperwork requirements to a minimum;
Allow for as much local flexibility and discretion as is possible 
within the law;
Ensure the most productive use of limited Federal resources;
Protect the Federal interest in local investments; and
Incorporate good management principles into the grant management 
process.
As mass transportation needs have changed over the years, so have the 
requirements for Federal financial assistance under the Federal transit 
laws and related statutes. FTA's regulatory priorities for 2003-2004 
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

[[Page 72540]]

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 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.
In conjunction with the Office of the Secretary, 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 safest, most reliable, and most efficient Seaway System possible.
_______________________________________________________________________
DOT--Office of the Secretary (OST)

                              -----------

                            FINAL RULE STAGE

                              -----------

95. [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 has regulated 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 disclosing fares and travel agency 
service fees by travel agencies. The Department has issued a notice of 
proposed rulemaking that tentatively concluded that most of the rules 
should be readopted, possibly with changes, for comment on other 
options, including terminating most or all of the rules. As part of 
this action, we are 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 no system operating in 
the United States is controlled by any U.S. 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

[[Page 72541]]

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 a notice of 
proposed rulemaking asking for comment on whether the Department should 
readopt most of the existing rules, except the rules prohibiting 
systems from charging airlines discriminatory fees and the rule 
requiring airlines with a system ownership interest to sell their 
services through competing systems. The Department also asked for 
comment on whether the rules should be phased out or eliminated, and on 
whether the rules should be strengthened in several respects.


Anticipated Cost and Benefits:


The Department included 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 had also been able to 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 could also impose excessive costs 
on the systems and airlines. The Department asked for comment on 
whether the risks still exist in light of on-going industry 
developments 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            67 FR 69366                                    11/15/02
NPRM Extension o67 FR 72869eriod                               12/09/02
NPRM Notice of Petition Response Date                          01/09/03
NPRM Comment Period End                                        01/14/03
NPRM Reply Comment Period End                                  02/13/03
Extended Comment Period End                                    03/16/03
NPRM Comment Per68 FR 24896d                                   05/09/03
Extended Reply Comment Period End                              05/15/03
Comment Period End                                             06/09/03
Final Action                                                   01/00/04
Regulatory Flexibility Analysis Required:


Yes


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
C-30
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4731
Email: [email protected]
RIN: 2105-AC65
_______________________________________________________________________
DOT--Federal Aviation Administration (FAA)

                              -----------

                            FINAL RULE STAGE

                              -----------

96. [rplus]FLIGHT SIMULATION DEVICE QUALIFICATION
Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 44701 to 44703; 49 USC 44707; 49 
USC 44709; 49 USC 44711; 49 USC 45102 to 45103; 49 USC 45301 to 45302


CFR Citation:


14 CFR 1; 14 CFR 11; 14 CFR 60; 14 CFR 61; 14 CFR 63; 14 CFR 141; 14 
CFR 142


Legal Deadline:


None


Abstract:


This action will amend the regulations establishing flight simulation 
device qualification requirements for all certificate holders in a new 
part. The basis of these requirements currently exists in different 
parts of the FAA's regulations and in advisory circulars. The proposed 
changes would consolidate and update flight simulation device 
requirements. This action is significant because of substantial public 
interest.


Statement of Need:


It is important to consolidate and update flight simulation device 
requirements to ensure that users of flight simulation devices receive 
the best possible training in devices that closely match the 
performance and handling characteristics of the aircraft being 
simulated.


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:


The FAA chartered an Aviation Rulemaking Committee to develop 
alternative rule language to Notice No. 02-11.


Anticipated Cost and Benefits:


The FAA has placed a Draft Regulatory Evaluation of the NPRM in the 
docket.

[[Page 72542]]

Risks:


The purpose of this rulemaking is to ensure that users of flight 
simulation devices receive the best possible training in devices that 
closely match the performance and handling characteristics of the 
aircraft being simulated.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 20284                                    09/25/02
NPRM Comment Per67 FR 69149d                                   11/15/02
Notice of On-Lin67 FR 70184rum                                 11/21/02
NPRM Comment Period End                                        12/24/02
NPRM Extended Comment Period End                               02/24/03
Final Action                                                   06/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Edward Cook
Flight Standards Service
Department of Transportation
Federal Aviation Administration
1701 Columbia Avenue
College Park, GA 30337
Phone: 404 305-6100
RIN: 2120-AH07
_______________________________________________________________________
DOT--National Highway Traffic Safety Administration (NHTSA)

                              -----------

                             PRERULE STAGE

                              -----------

97. [bull] [rplus]REFORMING THE AUTOMOBILE FUEL ECONOMY STANDARDS 
PROGRAM
Priority:


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


Legal Authority:


49 USC 32910


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


Through this action, the agency intends to begin a public discussion on 
potential ways, within current statutory authority, to update the 
Corporate Average Fuel Economy (CAFE) Program and to make it more 
consistent with our public policy objectives. The agency will seek 
comments on a number of possible concepts and measures, and invite the 
public to present additional concepts not presented here. The 
discussion is not intended to address the stringency of proposed CAFE 
standards in the future, but rather the basic structure of the CAFE 
program. The agency is interested in any suggestions towards revamping 
the CAFE program in such a way as to enhance overall fuel economy while 
protecting occupant safety and American jobs.


The potential changes range from modest changes to existing definitions 
separating passenger cars from light trucks (i.e., vans, pickup trucks 
and SUVs) to more significant structural changes to light truck fuel 
economy standards. The definitional changes could potentially expand 
the definition of light truck to include larger SUV's that are not 
currently subject to fuel economy standards, add criteria to existing 
definitions of light trucks and ensure that vehicles subject to the 
lower fuel economy standards applicable to trucks have sufficient 
functionality to be properly classified as trucks. The advance notice 
also requests comment on changing the existing approach to setting 
light truck fuel economy standards from one of setting a fixed standard 
applicable to all sizes of trucks in the light truck fleet to one of 
setting a standard that changes in relationship to a selected attribute 
of trucks in the fleet. Under such an attribute-based standard, the 
required fuel economy would change in relationship to either the weight 
of the vehicle, the size of the vehicle, or both.


Statement of Need:


There are four prominent criticisms of the light truck CAFE program. 
They relate to energy security, traffic safety, employment of American 
workers, and modernization of the definition and classification of 
light trucks. First, concern has been raised that the energy-saving 
potential of the CAFE program is hampered by the current regulatory 
structure. Second, concern has been raised that the current light truck 
CAFE standards could create safety risks by encouraging vehicle 
manufacturers to achieve greater fuel economy by downweighting their 
light truck offerings. A third reason for considering CAFE reform 
relates to the adverse economic impacts that may result from such 
future increases in the stringency of CAFE standards. A fourth reason 
for considering CAFE reform is to modernize the definitions and 
classifications of light trucks within the program. The markets for, 
and designs of, cars and light trucks have changed substantially since 
the inception of the CAFE program in the late 1970's.


Summary of Legal Basis:


Section 32910(d) of Title 49 of the United States Code provides that 
the Administrator may prescribe regulations necessary to carry out his 
duties under Chapter 329, Automobile fuel economy.


Alternatives:


The advanced notice of proposed rulemaking sets forth a number of 
alternative courses of action that could be pursued singly or in 
combination. In addition to these, the agency could simply choose not 
to pursue any changes to the CAFE program.


Anticipated Cost and Benefits:


The costs and benefits of the potential changes addressed in this 
action have not yet been assessed. Given the wide variety of actions 
that could be taken, calculating, estimating or predicting the costs 
and benefits for the potential changes would be extremely speculative.


Risks:


Changes to the structure of the CAFE standards or changes to the 
definitions of light trucks may have positive or negative safety 
impacts. Given the wide variety of actions that could be taken, 
calculating, estimating or predicting safety impacts for the potential 
changes would be extremely speculative.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM                                                          11/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


No


Government Levels Affected:


Undetermined

[[Page 72543]]

Agency Contact:
Otto Matheke
Attorney, Office of the Chief Counsel
Department of Transportation
National Highway Traffic Safety Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-5253
RIN: 2127-AJ17
_______________________________________________________________________
DOT--NHTSA

                              -----------

                          PROPOSED RULE STAGE

                              -----------

98. [bull] [rplus]SIDE IMPACT PROTECTION UPGRADE-STANDARD 214
Priority:


Other Significant


Legal Authority:


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


CFR Citation:


49 CFR 571.214


Legal Deadline:


None


Abstract:


Two Federal motor vehicle safety standards (FMVSS) No. 201, ``Occupant 
Protection in Interior Impact'' and No. 214, ``Side Impact 
Protection,'' specify requirements for side impact protection. At 
present, FMVSS No. 214 specifies a moving deformable barrier (MDB) test 
addressing mainly the chest injury problem. The head injury reduction 
is partially addressed in FMVSS No. 201. The agency is considering 
amending FMVSS No. 214 to add a vehicle-to-pole impact test to reduce 
the number of fatal and serious head injuries not addressed in FMVSS 
No. 201.


Statement of Need:


While the side impact protection standard currently specifies a MDB 
test for the purpose of reducing chest injuries, the head injury 
problem in side crashes is not addressed by the standard. In 1990, when 
the standard was published, no safety countermeasures were available to 
address this problem effectively. In 1995, the agency amended the 
occupant protection in the interior impact standard (FMVSS No. 201) to 
add an in-vehicle component test for enhanced upper interior head 
impact protection. However, head impacts with exterior objects, such as 
trees, poles, and narrow rigid structures, are not addressed in the 
requirements of FMVSS No. 201. These head impacts constitute a serious 
safety problem today. On the other hand, there are readily available 
countermeasures now, such as advanced inflatable head protection 
systems, which would provide occupant protection in these crashes. The 
agency plans to address this safety problem by amending the side impact 
protection standard (FMVSS No. 214) to add a vehicle-to-pole test.


Summary of Legal Basis:


Section 30111, title 49 of the USC, states that 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 to improve the side impact 
standard.


Alternatives:


The agency will examine existing test procedures developed by various 
organizations, conduct research on the development of a new MDB and 
advanced dummy test devices, and keep abreast of the development of new 
head protection systems.


Anticipated Cost and Benefits:


The agency is evaluating the benefits and costs associated with 
requiring a vehicle-to-pole test in FMVSS No. 214.


Risks:


Current motor vehicles provide numerous occupant protection systems, 
such as air bags, safety seat belts, and strategically placed energy 
absorption padding. Nevertheless, approximately 1,440 fatal and 2,400 
serious head injuries involving nearside occupants occur annually in 
non-rollover side crashes without full occupant ejections. ``Nearside 
occupants'' are those sitting on the struck side of the vehicle in 
which they are riding.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Lori Summers
Division Chief
Department of Transportation
National Highway Traffic Safety Administration
NVS-112
Light Duty Vehicle Division
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4917
Fax: 202 366-4329

Dr. William R.S. Fan
Safety Standards Engineer
Department of Transportation
National Highway Traffic Safety Administration
Room 5320F, NVS-112
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4922
Fax: 202 366-4329
RIN: 2127-AJ10
BILLING CODE 4910-62-S

[[Page 72544]]

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 economies, 
            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 the revenue 
            and collecting the correct amount of revenue under the 
            Internal Revenue Code, overseeing customs revenue 
            functions, financing the Federal Government and managing 
            its fiscal operations, and producing our Nation's coins and 
            currency.
[sbull] To safeguard our financial systems by enforcing laws relating 
            to Federal Government securities and developing regulations 
            to combat money laundering.
 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, 2001, the President signed 
the USA PATRIOT Act of 2001 into law on October 26, 2001. Over the past 
two years, 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).
 On November 26, 2002, the President signed into law the Terrorism Risk 
Insurance Act of 2002. The purpose of this legislation is to address 
disruptions in the market for terrorism risk insurance. The new law 
established a temporary Federal reinsurance program under which the 
Federal Government will share the risk of losses associated with 
certain types of terrorist acts with commercial property and casualty 
insurers. Over the past year, the Department of the Treasury has 
accorded the highest priority to developing and issuing regulations to 
implement the provisions of this Act. These efforts, which will 
continue during the coming year, are reflected in the regulatory 
priorities of the Terrorism Risk Insurance Program Office.
 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.
Terrorism Risk Insurance Program Office
 The Office of the Assistant Secretary for Financial Institutions is 
responsible for developing promulgating regulations implementing the 
Terrorism Risk Insurance Act of 2002 (TRIA). The Terrorism Risk 
Insurance Program Office, which is part of the Office of the Assistant 
Secretary for Financial Institutions, is responsible for operational 
implementation of the Act. The purposes of this legislation, which was 
enacted as a consequence of the events of September 11, 2001, are to 
address market disruptions, ensure the continued widespread 
availability and affordability of commercial property and casualty 
insurance for terrorism risk, and to allow for a transition period for 
the private markets to stabilize and build capacity while preserving 
State insurance regulation and consumer protections. TRIA established a 
temporary Federal reinsurance program under which the Federal 
Government will share the risk of losses associated with certain types 
of terrorist acts with commercial property and casualty insurers.
 Over the past year, the Office of the Assistant Secretary has worked 
quickly to implement TRIA by issuing both informal guidance and formal 
regulations. The regulations issued to date set forth key definitions 
that Treasury will use in implementing the Program as well as 
procedures insurers must follow to comply with the requirements of 
TRIA. During fiscal year 2004, the Office will focus on developing 
regulations to implement the procedures and policies associated with 
filing claims under TRIA.
Customs Revenue Functions
 On November 25, 2002, the President signed the Homeland Security Act 
of 2002 (the Act), establishing the Department of Homeland Security 
(DHS). The Act transferred the United States Customs Service from the 
Department of the Treasury to the DHS, where it is now known as the 
Bureau of Customs and Border Protection (BCBP). Notwithstanding the 
transfer of the Customs Service to DHS, the Act provides that the 
Secretary of the Treasury retains sole legal authority over the customs 
revenue functions. The Act also authorizes the Secretary of the 
Treasury to delegate any of the retained authority over customs revenue 
functions to the Secretary of Homeland Security. By Treasury Department 
Order No. 100-16, the Secretary of the Treasury delegated to the 
Secretary of Homeland Security authority to prescribe regulations 
pertaining to the customs revenue functions. This Order further 
provided that the Secretary of the Treasury retained the sole authority 
to approve any such regulations concerning import quotas or trade bans, 
user fees, marking, labeling, copyright and trademark enforcement, and 
the completion of entry or substance of entry summary including duty 
assessment and collection, classification, valuation, application of 
the U.S. Harmonized Schedules, eligibility or requirements for 
preferential trade programs and the establishment of recordkeeping 
requirements relating thereto.
 During fiscal year 2003, Treasury and CBP issued several regulations 
involving the customs revenue functions not delegated to DHS. Among 
these were the following interim regulations that implement the trade 
benefit provisions of the Trade Act of 2002:
[sbull] The Andean Trade Promotion and Drug Eradication Act
[sbull] The Caribbean Basin Economic Recovery Act
[sbull] The African Growth and Opportunity Act
 During fiscal year 2004, Treasury and BCBP plan to finalize these 
interim regulations. In addition, Treasury and BCBP plan to finalize 
regulations that will implement a provision of the Tariff and 
Suspension Act of 2000 by

[[Page 72545]]

establishing procedures for allowing the duty-free entry of prototypes 
that are to be used exclusively in product development, testing, 
evaluation or quality control.
 Treasury and BCBP also plan to continue moving forward with amendments 
to improve its regulatory procedures 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. BCBP will also continue to test new programs to see if they 
work before proceeding with proposed rulemaking to permanently 
establish the programs.
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 fiscal year 2004, the CDFI Program will comprise two 
components: the Financial Assistance Component and the Technical 
Assistance Component. In addition, the Fund administers the Native 
American CDFI Development (NACD) 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 fiscal year 2004, the Fund also plans 
to administer the Native American CDFI Assistance (NACA) Program, which 
will provide financial assistance awards and technical assistance 
grants (including operating grants and grants to purchase goods and 
services) to CDFIs that serve Native American, Alaska Native, and 
Native Hawaiian communities, or ``sponsor organizations'' (i.e., 
nonprofits or tribes or tribal entities that will form CDFIs that serve 
Native American, Alaska Native, and/or Native Hawaiian communities).
 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 2004 regulatory priority will focus on the NMTC 
Program, by developing guidance and/or regulations regarding aspects of 
the administration and operation of the program.
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, 
Terrorism/Violent Crimes, 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 2004 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 implements 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 
            baking accounts established or maintained for non-U.S. 
            persons.
[sbull] Anti-Money Laundering Programs. These final and proposed rules 
            implement section 352 of the USA PATRIOT Act, under which 
            financial institutions must adopt anti-money laundering 
            programs. FinCEN expects to finalize interim final rules 
            issued in April 2002 for banks and other depository 
            institutions, casinos, securities broker-dealers, futures 
            commissionmerchants, mutual funds, operators of credit card 
            systems, and money services businesses. FinCEN also expects 
            to finalize rules proposed in September 2002 for insurance 
            companies and unregistered investment companies, rules 
            proposed in February 2003 for dealers in precious metals, 
            stones, or jewels, and rules proposed in May 2003 for 
            investment advisers and commodity trading advisers. FinCEN 
            will issue a proposed rule for loan or finance companies 
            (including pawnbrokers). Finally, FinCEN expects to 
            determine whether to issue a series of proposed rules for 
            other financial institutions'vehicles sellers; persons 
            involved in real estate closings and settlements; and 
            travel agencies'after reviewing comments received in 
            response to a series of advance notices of proposed 
            rulemaking.
[sbull] Suspicious Activity Reporting. FinCEN expects to finalize rules 
            proposed under section 356(b) of the USA PATRIOT Act, which 
            requires futures commission merchants to report suspicious 
            transactions. FinCEN also expects to finalize several rules 
            proposed under 31 U.S.C. 5318(g) equiring insurance 
            companies, mutual funds, and futures commission merchants 
            to report suspicious transactions.
Internal Revenue Service
 The Internal Revenue Service, 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.

[[Page 72546]]

 Most Internal Revenue Service 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 2004 the Internal Revenue Service will accord 
priority to the following regulatory projects:
[sbull] Application of the Repeal of the General Utilities Doctrine in 
            the Context of Consolidated Returns. The IRS and Treasury 
            intend to issue additional regulatory guidance on the 
            application of the repeal of the General Utilities doctrine 
            in the context of consolidated returns. The repeal of 
            General Utilities is intended to preserve the integrity of 
            the corporate tax base by ensuring that corporate level tax 
            is ultimately paid on the net income of taxable 
            corporations and the net appreciation in their assets. This 
            project involves ensuring that this result occurs in the 
            context of consolidated returns. Consolidated returns have 
            a system in which the tax basis in the stock of subsidiary 
            members is adjusted to reflect income earned by the 
            subsidiary. Under this system, when the group starts out 
            with more basis in the stock of a subsidiary than the 
            subsidiary has in its assets--for example, when the group 
            buys the stock of a corporation at a price that reflects 
            the unrealized appreciation in the corporation's assets--it 
            may be possible to structure transactions that undermine 
            the intended effect of General Utilities repeal.
The IRS and Treasury issued temporary regulations (26 CFR 1.337(d)-2T) 
that disallow certain losses that have the effect of offsetting the 
taxable income or gain that should exist under General Utilities 
repeal. During the coming fiscal year, the IRS and Treasury plan to 
reexamine these regulations and issue new regulatory guidance (of a 
type to be determined once the project is well under way).
[sbull] Safe Harbor Methodology for Determining the Fair Market Value 
            of Financial Instruments that are Marked to Market. Section 
            475 of the Internal Revenue Code requires dealers in 
            stocks, evidences of indebtedness, derivative financial 
            instruments, and other securities to mark those securities 
            to market at the end of each tax year. That is, those 
            dealers must compute their taxable income by either 
            including those securities in inventory, or treating them 
            as having been sold, for their fair market value at the end 
            of the tax year. Certain dealers in commodities and traders 
            in securities or commodities may elect to mark those 
            securities or commodities to market under section 475. 
            There have been disagreements between the IRS and some 
            taxpayers about how to determine the fair market value of 
            some securities, including certain derivative financial 
            instruments. The IRS and Treasury are considering whether 
            to publish proposed regulations that would allow dealers in 
            securities (and perhaps dealers in commodities and traders 
            in securities or commodities) to use a safe harbor method 
            to satisfy the statutory requirement to determine the fair 
            market value of items marked to market. As a first step in 
            this process, the IRS and Treasury issued an advance notice 
            of proposed rulemaking (ANPRM) on May 5, 2003, describing 
            and explaining a possible framework for a safe harbor that 
            might allow taxpayers to use as fair market value for 
            section 475 purposes the value used on certain financial 
            statements. That ANPRM stated certain broad principles that 
            any safe harbor finally adopted would have to meet 
            (including the importance of maintaining and furnishing to 
            the IRS appropriate records) and requested both general and 
            specific comments concerning the adoption of a financial 
            statement conformity (or other) safe harbor. It also 
            requested comments on the scope of any safe harbor, 
            concerning which taxpayers could use it, what financial 
            statements would qualify, and what securities (or 
            commodities) would be covered.
Whether this regulation is of particular concern to small business 
depends on decisions to be made in the future about whether to limit 
the scope of the project to dealers in securities or to extend it to 
traders. Few if any dealers in securities are small businesses, but 
many traders in securities or commodities may be small businesses.
[sbull] Capitalization of Interest and Carrying Charges Properly 
            Allocable to Straddles. Sections 1092 and 263(g) were 
            enacted in 1981 to address tax abuses caused by straddles 
            in commodity futures contracts but are broadly worded to 
            deal with other abusive straddles. Section 1092 limits loss 
            recognition on a position in a straddle where there are two 
            or more offsetting positions in the same personal property. 
            Section 263(g) disallows a deduction for interest and 
            carrying charges properly allocable to personal property 
            that is part of a straddle. In general, a straddle arises 
            when a taxpayer holds offsetting positions with respect to 
            personal property. The positions are described as 
            offsetting because the taxpayer's risk of loss in one 
            position is substantially diminished due to the second 
            position.
The IRS and Treasury will issue final regulations clarifying the 
circumstances in which a taxpayer must capitalize interest and carrying 
charges incurred to purchase or carry personal property that is part of 
a straddle. The regulations will address the definition of personal 
property for purposes of section 263(g), the types of expenses to be 
subject to capitalization, and the operation of the capitalization 
rules. In addition, the regulations will indicate when a debt 
obligation will be treated as a position in personal property that is 
part of a straddle. The regulations will also clarify the application 
of the straddle anti-abuse rules to various financial instruments and 
straddle transactions that have been developed since 1981.
[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 section 263(a), however, no 
            immediate deduction is allowed for expenditures to acquire, 
            create, or enhance property with a useful life that extends 
            substantially beyond the taxable year. Such expenditures 
            are capital expenditures that generally may be recovered 
            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 to acquire, create, or enhance intangible 
            assets or benefits are currently deductible under section 
            162, or are capital expenditures under section 263(a). The 
            IRS and Treasury issued proposed regulations on December 
            19, 2002, that provide rules to clarify the circumstances 
            in which taxpayers must capitalize expenditures to acquire, 
            create, or enhance intangible assets or benefits. During 
            fiscal year 2004, the IRS and Treasury intend to finalize 
            these regulations.
[sbull] Credit for Household and Dependent Care Services. Section 21 of 
            the Internal Revenue Code allows a credit for an amount 
            equal to a percentage of employment-

[[Page 72547]]

            related expenses paid by an individual who maintains a 
            household that includes a qualifying individual (usually a 
            child under age 13). Section 21, originally enacted in 
            1976, has been amended repeatedly. The 2001 amendments 
            increased the credit significantly. The regulations, 
            currently found under section 1.44A of the Income Tax 
            Regulations, have not been amended or updated since 1984. 
            This regulation project will update the regulations to 
            reflect the statutory changes and will clarify issues 
            relating to payments for certain services.
[sbull] International Restructurings. Multinational businesses 
            operating in a global economy undergo acquisitions, 
            mergers, consolidations, and other reorganizations 
            involving entities in different countries. A number of 
            technical issues have arisen concerning the Federal income 
            tax treatment of these international restructurings. These 
            issues include, for example, the treatment under section 
            368(a)(1)(A) of statutory mergers and consolidations that 
            involve one or more foreign corporations, including 
            transactions involving a disregarded entity; the 
            application of the international provisions to section 304 
            transactions and other guidance in light of the 1997 
            amendments to section 304; the interaction of cross border 
            restructurings and the dual consolidated loss rules under 
            section 1503(d); and the effect of international 
            reorganizations on earnings and profits, including 
            previously taxed earnings and profits. The IRS and Treasury 
            expect to issue regulations that will address these issues 
            during fiscal year 2004.
[sbull] Dividends from Qualified Foreign Corporations Eligible for 15 
            Percent Rate. The Jobs and Growth Tax Relief Reconciliation 
            Act of 2003 affords the 15 percent rate to certain 
            dividends received by individuals from ``qualified foreign 
            corporations.'' A number of technical issues have arisen 
            concerning the application of this provision. These issues 
            include, for example, which treaties qualify as 
            comprehensive income tax treaties that have been determined 
            satisfactory for purposes of this provision, including an 
            exchange of information program; what is the test of 
            whether stock is readily tradable on an established 
            securities market in the United States; and the interaction 
            of this provision and various anti-deferral regimes. The 
            IRS and Treasury expect to issue regulations that will 
            interpret and address issues arising under this provision 
            during fiscal year 2004.
[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 2004.
[sbull] Partnership Equity for Services. Like other businesses, 
            partnerships frequently issue interests in partnership 
            equity to service providers. Although there currently is 
            some guidance on a partnership's issuance of a profits 
            interest to a service provider, there is little guidance on 
            the Federal income tax consequences (to the service 
            provider and the partnership) on the issuance, in 
            connection with the performance of services, of an interest 
            in partnership capital or an option to acquire such an 
            interest. More specifically, uncertainty exists as to 
            whether the principles of section 83 apply to the issuance 
            of such interests and whether the partnership recognizes 
            gain on the issuance of a capital interest to, or the 
            exercise of an option by, a service provider. In this 
            project, the IRS and Treasury will provide guidance on 
            these and related issues.
[sbull] Corporate Estimated Tax. Section 6655 of the Internal Revenue 
            Code sets forth the requirements for the payment of 
            estimated income taxes by corporations. The existing 
            regulations under section 6655 do not reflect significant 
            changes to the tax law since 1984. The IRS and Treasury 
            expect to issue proposed regulations that will reflect 
            changes to the tax law since 1984 and that will provide 
            clear rules for taxpayers to follow and the Internal 
            Revenue Service to administer. Among other issues, the 
            proposed regulations will address the alternative methods 
            for computing quarterly installments of estimated tax and 
            the treatment of certain items when computing quarterly 
            installments of estimated tax.
[sbull] Minimum Required Distributions. Section 401(a)(9) of the 
            Internal Revenue Code requires tax-qualified retirement 
            plans to begin distributions to participants and 
            beneficiaries upon the occurrence of certain events, such 
            as attainment of age 70\1/2\ and termination of employment. 
            Final regulations providing guidance on these requirements 
            as they apply to defined contribution plans were published 
            in the Federal Register on April 17, 2002. The IRS and 
            Treasury will issue regulations providing guidance on the 
            requirements of section 401(a)(9) as they apply to defined 
            benefit plans.
[sbull] Incentive Stock Options. Employers provide various types of 
            stock options to their employees. Certain stock options, 
            known as incentive stock options, are eligible for special 
            tax benefits that are not available for other stock 
            options. Specifically, if certain requirements are 
            satisfied, the employee is not taxed on the grant or the 
            exercise of the option, but only when the stock subject to 
            the option is sold. Moreover, if these requirements are 
            satisfied, the employee is taxed at capital gains rates, 
            rather than ordinary income rates. The IRS and Treasury 
            will issue final regulations providing comprehensive 
            guidance on the requirements applicable to incentive stock 
            options. Proposed regulations providing guidance on these 
            requirements were published in the Federal Register on June 
            9, 2003.
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

[[Page 72548]]

            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.
 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 2003 include:
[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.
[sbull] Customer Identification Programs for Banks, Savings 
            Associations, and Credit Unions (31 CFR 103 and 12 CFR 21). 
            The Department of the Treasury, through the Financial 
            Crimes Enforcement Network, the OCC, Board of Governors of 
            the Federal Reserve System, Federal Deposit Insurance 
            Corporation, Office of Thrift Supervision, and National 
            Credit Union Administration published a final rule 
            implementing section 326 of the Uniting and Strengthening 
            America by Providing Appropriate Tools Required to 
            Intercept and Obstruct Terrorism Act of 2001. Section 326 
            requires a regulation that contains minimum standards that 
            financial institutions must implement: 1) to verify the 
            identity of any person seeking to open an account; 2) to 
            maintain records of the information used to verify the 
            person's identity; and 3) to determine whether the person 
            appears on any lists of known or suspected terrorists or 
            terrorist organizations provided to the financial 
            institution by any Government agency.
[sbull] Rules, Policies, and Procedures for Corporate Activities 
            (Electronic Filings) (12 CFR Part 5). The OCC published an 
            interim rule with request for comment that would make 
            revisions to part 5 filing requirements to facilitate 
            electronic filings for certain applications. The purpose of 
            these changes is to permit national banks to file certain 
            classes of applications electronically and to inform 
            national banks where they may find detailed procedural 
            information on electronic filings. The rule clarifies 
            circumstances under which the OCC may adopt filing 
            procedures different from those otherwise required by part 
            5.
[sbull] Removal, Suspension, and Debarment of Accountants From 
            Performing Audit Services (12 CFR Part 19). The OCC, Board 
            of Governors of the Federal Reserve System, Federal Deposit 
            Insurance Corporation, and Office of Thrift Supervision, 
            published a final rule 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). The final rule establishes rules of practice 
            and procedure to implement this authority and reflect the 
            agencies' increasing concern with the quality of audits and 
            internal controls for financial reporting at insured 
            depository institutions. The final rule enhances the 
            agencies' ability to address misconduct by accountants who 
            perform annual audit and attestation services.
[sbull] Community and Economic Development Entities, Community 
            Development Projects and Other Public Welfare Investments 
            (12 CFR Part 24). The OCC published a final rule amending 
            part 24, the regulation governing national bank investments 
            that are designed primarily to promote the public welfare. 
            The final rule updates the regulation to reflect the 
            additional types of public welfare investment structures 
            that have become more common in recent years and that are 
            permissible under the governing statute. It also clarifies 
            the statutory standard that applies to the activities of 
            those entities; simplifies the standards for making public 
            welfare investments; clarifies how a national bank 
            calculates the value of its public welfare investments for 
            purposes of complying with the rule's investment limits; 
            simplifies the regulation's investment self-certification 
            and prior approval processes; and expands the list of 
            examples of qualifying public welfare investments that 
            satisfy the rule's requirements.
 The OCC's regulatory priorities for fiscal year 2004 include projects 
in the following areas:
[sbull] Risk-Based Capital Guidelines; Capital Adequacy Guidelines; 
            Capital Maintenance: Interim Capital Treatment of 
            Consolidated Asset-Backed Commercial Paper Program Assets 
            (12 CFR Part 3). The Office of the Comptroller of the 
            Currency, together with the Board of Governors of the 
            Federal Reserve System, Federal Deposit Insurance 
            Corporation, and Office of Thrift Supervision, are planning 
            to amend their risk-based capital standards by providing an 
            interim treatment for assets in asset-backed commercial 
            paper (ABCP) programs that are consolidated onto the 
            balance sheets of sponsoring banks, bank holding companies, 
            and thrifts (collectively, sponsoring banking 
            organizations) as a result of a recently issued accounting 
            interpretation, Financial Accounting Standards Board 
            Interpretation No. 46, Consolidation of Variable Interest 
            Entities (FIN 46). Specifically, the interim capital 
            treatment allows sponsoring banking organizations to remove 
            consolidated ABCP program assets from their risk-weighted 
            asset base for the purpose of calculating their risk-based 
            capital ratios. This interim capital treatment will be in 
            effect only for the regulatory reporting periods ending 
            September 30 and December 31, 2003, and March 31, 2004. 
            This interim rule is planned to be issued in conjunction 
            with a joint agency notice of proposed rulemaking that 
            would also require banking organizations to hold risk-based 
            capital against liquidity facilities provided to ABCP 
            programs with an original maturity of one year or less, and 
            a risk-based capital charge for early amortization risk 
            associated with certain types of revolving securitizations.
[sbull] Risk-Based Capital Guidelines; Implementation of New Basel 
            Capital Accord (12 CFR Part 3). The OCC, Board of Governors 
            of the Federal Reserve System, Federal Deposit Insurance 
            Corporation, and Office of Thrift Supervision published an 
            advance notice of proposed rulemaking

[[Page 72549]]

            (ANPRM) soliciting industry comments on a proposed 
            framework for implementing the New Basel Capital Accord in 
            the United States. In particular, this ANPRM describes 
            significant elements of the Advanced Internal Ratings-Based 
            approach for credit risk and the Advanced Measurement 
            Approaches for operational risk (together, the advanced 
            approaches). The ANPRM specifies criteria that would be 
            used to determine banking organizations that would be 
            required to use the advanced approaches, subject to meeting 
            certain qualifying criteria, supervisory standards, and 
            disclosure requirements. Other banking organizations that 
            meet the criteria, standards, and requirements also would 
            be eligible to use the advanced approaches. Under the 
            advanced approaches, banking organization would use 
            internal estimates of certain risk components as key inputs 
            in the determination of their regulatory capital 
            requirements.
[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 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] Recordkeeping Requirements for Bank Exceptions from Securities 
            Broker or Dealer Registration (12 CFR To Be Determined). 
            The OCC, Board of Governors of the Federal Reserve System, 
            Federal Deposit Insurance Corporation, and Office of Thrift 
            Supervision are planning to issue a joint notice of 
            proposed rulemaking that contains recordkeeping 
            requirements that implement section 204 of the Gramm-Leach-
            Bliley Act. Section 204 directs the Federal banking 
            agencies to establish recordkeeping requirements for banks 
            relying on exceptions to the definitions of ``broker'' and 
            ``dealer'' contained in paragraphs (4) and (5) of section 
            3(a) of the Securities Exchange Act of 1934.
[sbull] Fair Credit Reporting Act (12 CFR Part 41). The OCC, along with 
            the Board of Governors of the Federal Reserve System, 
            Federal Deposit Insurance Corporation, and Office of Thrift 
            Supervision, are planning to publish a revised notice of 
            proposed rulemaking concerning a rule that would 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] Rules, Policies, and Procedures for Corporate Activities; Bank 
            Activities and Operations; Real Estate Lending and 
            Appraisals (12 CFR Parts 3, 5, 6, 7, 9, 28, and 34). The 
            OCC published a notice of proposed rulemaking that proposed 
            to amend several of its regulations to update and clarify 
            them in various respects. Proposed revisions to parts 5 and 
            7 would implement new authority provided to national banks 
            by sections 1204, 1205, and 1206 of the American 
            Homeownership and Economic Opportunity Act of 2000. Section 
            1204 permits national banks to reorganize directly to be 
            controlled by a holding company. Section 1205 increases the 
            maximum term of service for national bank directors, 
            permits the OCC to adopt regulations allowing for staggered 
            terms for directors, and permits national banks to apply 
            for permission to have more than 25 directors. Section 1206 
            permits national banks to merge with one or more of their 
            nonbank affiliates, subject to OCC approval. In order to 
            clarify issues that have arisen in connection with the 
            scope of OCC's visitorial powers, the proposal would revise 
            part 7. The proposal also contains other amendments to 
            parts 5, 7, 9, and 34, as well as several technical 
            corrections.
[sbull] Community Reinvestment Act (CRA) Regulations (12 CFR Part 25). 
            The OCC, Board of Governors of the Federal Reserve System, 
            Federal Deposit Insurance Corporation, and Office of Thrift 
            Supervision, 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] Maintenance of Records (12 CFR Part 7). The OCC plans to issue 
            a notice of proposed rulemaking that would invite comment 
            on a revision to part 7 that would require entities subject 
            to the jurisdiction of the OCC to establish and maintain 
            accurate and complete documentation and records, and allow 
            the OCC timely access to such records. The proposed 
            revision would also provide that when a bank discloses 
            documents and records to the OCC during the supervisory 
            process, such a disclosure is not voluntary and is not made 
            to an adversary.
[sbull] Rules, Policies, and Procedures for Corporate Activities; 
            International Banking Activities (12 CFR Parts 5 and 28). 
            The OCC issued a notice of proposed rulemaking proposing to 
            amend its regulations pertaining to the foreign operations 
            of national banks, and of Federal branches and agencies of 
            foreign banks operating in the United States. The OCC is 
            clarifying or revising a number of application procedures, 
            including the standards for approval that would apply. It 
            permits Federal branches and agencies to operate with one 
            license in the United States, with a license issued only 
            for the initial Federal branch or agency, rather than 
            requiring each office of a foreign bank to have a separate 
            license. It also permits a Federal branch to operate a loan 
            production office as part of its branch license. In 
            addition, the OCC proposes to implement through its 
            regulation a number of OCC interpretations regarding the 
            capital equivalency deposit required of Federal branches 
            and agencies. The OCC also proposes to revise several 
            definitions.
[sbull] Interagency Guidelines Establishing Standards for Safety and 
            Soundness (12 CFR Part 30). The OCC, Board of Governors of 
            the Federal Reserve System, Federal Deposit Insurance 
            Corporation, and Office of Thrift Supervision, plan to 
            issue a notice of proposed rulemaking to amend their 
            Interagency Guidelines to add a new subsection, pursuant to 
            which a depository institution should establish and 
            maintain new policies and standards designed to ensure an 
            effective system of corporate governance. This amendment is 
            intended to address potential weaknesses in management and 
            corporate governance practices.
[sbull] Change in Business Plans (12 CFR Part 5). The OCC intends to 
            seek

[[Page 72550]]

            comment on a proposed rule that would require national 
            banks to notify the OCC of material changes in business 
            plans.
[sbull] Reporting and Disclosure Requirements for National Banks With 
            Securities Registered Under the Securities Exchange Act of 
            1934; Securities Offering Disclosure Rules (12 CFR Parts 11 
            and 16). The OCC published a notice of proposed rulemaking 
            to revise its regulations to reflect amendments to the 
            Securities Exchange Act of 1934 (Exchange Act) made by the 
            Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley Act). These 
            amendments to the Exchange Act give the OCC the authority 
            to administer and enforce a number of the Sarbanes-Oxley 
            Act's new reporting, disclosure, and corporate governance 
            requirements with respect to national banks that have a 
            class of securities registered under the Exchange Act. The 
            OCC is also proposing to make conforming revisions to its 
            rules that prescribe securities offering disclosure rules 
            for national banks that issue securities that are not 
            subject to the registration requirements of the Securities 
            Act of 1933.
[sbull] Bank Activities and Operations; Real Estate Lending and 
            Appraisals (12 CFR Parts 7 and 34). The OCC issued a notice 
            of proposed rulemaking to amend parts 7 and 34 of its 
            regulations to add provisions clarifying the applicability 
            of state law to national banks. These provisions would 
            identify types of State laws that are preempted, as well as 
            types of State laws that generally are not preempted, in 
            the context of national bank lending, deposit-taking, and 
            other authorized activities.
[sbull] Rules, Policies, and Procedures for Corporate Activities (12 
            CFR Part 5). The OCC plans to issue a notice of proposed 
            rulemaking that will require national banks to receive OCC 
            approval before selling or otherwise disposing of all or 
            substantially all of its assets. This proposed rule also 
            provides that the OCC will apply the same standards as it 
            applies to the establishment of a de novo bank to notices 
            to acquire control of such bank.
[sbull] Electronic Filing and Disclosure of Beneficial Ownership 
            Reports (12 CFR Part 11). The OCC plans to issue an interim 
            rule with request for comments that implements provisions 
            enacted in the Sarbanes-Oxley Act of 2002 requiring the 
            electronic filing of certain beneficial ownership reports 
            by officers, directors, and major shareholders (insiders) 
            that have equity securities registered under the Securities 
            Exchange Act of 1934. Insiders of registered national banks 
            must file these reports with the OCC. This interim rule 
            requires that, in addition to the statutory requirements, 
            all beneficial ownership reports required to be filed with 
            the OCC must be filed electronically and posted on a 
            registered national bank's Web site, if it has one. The 
            Board of Governors of the Federal Reserve System and the 
            Federal Deposit Insurance Corporation are imposing similar 
            requirements.
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, timely 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. This 
            initiative was published, along with draft supervisory 
            guidance, as an advance notice of proposed rulemaking, 
            introducing the domestic implementation of the New Basel 
            Capital Accord (Basel II). It included an introduction to 
            the advanced internal ratings-based (IRB) approach to 
            credit risk, and included modifications to the current U.S. 
            domestic capital framework.
[sbull] Capital Adequacy. The four Federal banking agencies plan to 
            issue a joint notice of proposed rulemaking seeking comment 
            on ways to modify the capital adequacy framework for all 
            banking organizations. Among the elements of the proposal 
            will be consideration of a uniform regulatory structure, 
            elimination of outdated requirements, reallocation of 
            certain assets to more appropriate risk weights, and 
            general streamlining and burden reduction.
 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.
 OTS plans to issue a final rule conforming its regulations on 
transactions with affiliates to Regulation W and implementing 
additional restrictions imposed on savings associations under section 
11(a) of the Home Owners' Loan Act. Also, OTS plans to adopt as final 
an interim rule that amended its annual independent audit requirements 
for small, nonpublic, highly rated savings associations that 
voluntarily obtain independent audits. Additionally, OTS is issuing a 
final rule amending its regulation governing agency offices of Federal 
savings associations to conform that regulation to recent changes to 
OTS' fiduciary activities regulations.
Alcohol and Tobacco Tax and Trade Bureau
 The Alcohol and Tobacco Tax and Trade Bureau (TTB) issues regulations 
to enforce the Federal laws relating to the manufacture and commerce of 
alcohol products, tobacco products, and the Federal excise tax on 
firearms and ammunition. TTB's mission and regulations are designed to:
[sbull] Regulate the alcohol and tobacco industries, including systems 
            for licenses and permits;
[sbull] Assure the collection of all alcohol, tobacco, and 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 and other Federal agencies in their efforts 
            to eliminate

[[Page 72551]]

            interstate trafficking in, and the sale and distribution 
            of, cigarettes in avoidance of State taxes.
In 2004, TTB will continue its multi-year plan to revise its 
regulations in plain language. TTB will update and revise regulations 
to be more clear and concise, using the principles of plain language. 
TTB began the groundwork for this priority in 2002 by starting 
recodifications in title 27 of the Code of Federal Regulations. These 
changes reorganize TTB regulations into a more logical sequence. The 
plain language revisions will make TTB rules more accessible to small 
businesses and to the public.
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), as amended.
[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 2004, BPD 
will give priority to developing technical conforming amendments to the 
customer protection requirements in the GSA regulations based on the 
recent changes made by the Securities and Exchange Commission to its 
customer protection rules for brokers and dealers. The modifications 
will allow for the expansion of the categories of collateral registered 
Government securities brokers and dealers may pledge when borrowing 
securities from customers. BPD also plans to give priority to expanding 
an exemption in the GSA regulations to include savings associations 
regulated by the Office of Thrift Supervision that hold Government 
securities in a fiduciary and custodial capacity.
 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 2004, BPD will accord 
priority to issuing the Uniform Offering Circular in plain language. 
This will communicate the auction rules in a more direct and effective 
manner.
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 2004, 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 will 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 that 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 will issue a final rule governing the indorsement and 
            payment of checks drawn on the United States Treasury. Last 
            fiscal year, FMS proposed revisions that 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 will issue a final rule governing the offset of 
            Federal Government payments to collect delinquent nontax 
            debt owed to Federal agencies. Last fiscal year, FMS issued 
            an interim rule (with request for comments) clarifying the 
            policies and procedures applicable to the collection of 
            such debt through the Treasury Offset Program.
_______________________________________________________________________
TREAS--Alcohol and Tobacco Tax and Trade Bureau (TTB)

                              -----------

                          PROPOSED RULE STAGE

                              -----------

99. 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


Abstract:


TTB intends to streamline regulations applying to breweries. TTB 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:


TTB 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

[[Page 72552]]

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:


TTB 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. TTB 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 TTB.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

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


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


Transferred from RIN 1512-AB37


Agency Contact:
Joanne Brady
TTB Specialist
Department of the Treasury
Tax and Trade Bureau
P.O. Box 45797
Philadelphia, PA 19149
Phone: 215 333-7050
Fax: 215 333-8871
Email: [email protected]
RIN: 1513-AA02
BILLING CODE 4810-25-S

[[Page 72553]]

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.
 VA's regulatory priorities include a special project to undertake a 
comprehensive review and improvement of its existing regulations. The 
first portion of this project is devoted to reviewing, reorganizing, 
and rewriting the VA's compensation and pension regulations found 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' 2003 regulatory plan contains one 
rulemaking action from the Veterans Health Administration. The Veterans 
Health Administration rulemaking is RIN 2900-AL51 
``Enrollment'Provision of Hospital and Outpatient Care to Veterans 
Subpriorities of Priority Categories 7 and 8 and Annual Enrollment 
Level Decision,'' which amends the Department's medical regulations to 
protect the quality and improve the timeliness of care provided to 
veterans in higher enrollment-priority categories.
_______________________________________________________________________
VA

                              -----------

                            FINAL RULE STAGE

                              -----------

100. ENROLLMENT--PROVISION OF HOSPITAL AND OUTPATIENT CARE TO 
VETERANS--SUBPRIORITIES OF PRIORITY CATEGORIES 7 AND 8 AND ENROLLMENT 
LEVEL DECISION
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 104-262


CFR Citation:


38 CFR 17.36


Legal Deadline:


None


Abstract:


As required by Public Law 104-262, the Veterans' Health Care 
Eligibility Reform Act of 1996, the Secretary of the Department of 
Veterans Affairs must make an annual decision concerning enrollment in 
VA's health care system in order to ensure that medical services 
provided are both timely and acceptable in quality. This document 
amends existing regulations to establish subpriorities within priority 
categories 7 and 8 and to publish FY 2003 enrollment decision as 
determined by the Secretary.


Statement of Need:


Public Law 104-262, the Veterans' Health Care Eligibility Reform Act of 
1996, requires the Secretary of Veterans Affairs to make annual 
decisions concerning enrollment in VA's health care system in order to 
ensure that resources are available to provide medical services that 
are both timely and acceptable in quality. This document announces the 
enrollment decision to suspend the enrollment of additional veterans 
who are in the lowest statutory enrollment category (priority category 
8). This also amends existing regulations to establish additional 
subpriorities within priority categories 7 and 8.


Summary of Legal Basis:


38 CFR 17.36(c) requires that the Secretary determine which categories 
of veterans are eligible to be enrolled and that the Secretary notify 
eligible enrollees of the determination by announcing it in the Federal 
Register.


Alternatives:


The Department had to consider placing additional enrollees on waiting 
lists and extending the waiting period for eligible enrollees seeking 
appointments for care as alternatives.


Anticipated Cost and Benefits:


By suspending enrollment of additional priority category 8 veterans, VA 
would avoid significant additional medical benefits costs and begin to 
bring demand in line with capacity, which will reduce the number of 
veterans on waiting lists. Without action to suspend new enrollment, 
the cost projection for FY 2003 is $23.455 billion. This is based on 
the projected average enrollment for FY 2003 of 6,991,405, together 
with the projected expenditures that would be needed to provide the 
medical benefits package to all enrollees. Suspending new enrollment 
would reduce enrollment in priority category 8 by 164,367 in FY 2003, 
which is expected to grow to over 520,000 by FY 2005.


Risks:


Without action to suspend new enrollment, patient safety and quality 
and access to care would be adversely affected.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Ru68 FR 2670                                     01/17/03
Interim Final Rule Effective                                   01/17/03
Interim Final Rule Comment Period End                          03/18/03
Final Action                                                   04/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 72554]]

Agency Contact:
Barbara Manning
Program Analyst (105D)
Department of Veterans Affairs
810 Vermont Avenue
Washington, DC 20420
Phone: 202 273-6097
Email: [email protected]
RIN: 2900-AL51
BILLING CODE 8320-01-S

[[Page 72555]]

ENVIRONMENTAL PROTECTION AGENCY (EPA)
Statement of Priorities
OVERVIEW
 The U.S. Environmental Protection Agency (EPA) is the leading Federal 
agency responsible for protecting environmental quality and controlling 
the effects of pollution on human health. Since its creation in 1970, 
EPA has taken actions that 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.
 EPA fulfills its mission using a variety of tools, such as technical 
assistance, funding, voluntary partnerships, research, and education. 
And in carrying out its statutory responsibilities, EPA also develops 
regulations that provide protection against a variety of environmental 
risks. In the coming year, EPA's top regulatory priority is supporting 
passage and implementation of the Clear Skies Initiative, a legislative 
proposal of the Bush Administration that would reduce emissions of the 
three most harmful air pollutants, nitrogen oxides, sulfur dioxides, 
and mercury, at levels 70 percent below year 2000 levels. Other 
regulatory priorities include completing rules that will reduce 
emissions from off-road diesel engines and reduce the risks from 
microbial pathogens, especially cryptosporidium, in drinking water.
Sound Science and Economic Analysis
 These and other regulatory activities are supported by a strong 
commitment to sound science and economic analysis. EPA conducts 
scientific and economic research on an ongoing basis, independently and 
in collaboration with others, to obtain the base of knowledge that is 
needed to understand and solve complex ecological and human health 
problems.
 EPA's priorities for scientific research align with the Agency's five 
strategic goals. For Clean Air, science priorities focus on emissions, 
fate and transport, exposures, mechanisms of injury, and health effects 
of criteria air pollutants. Science priorities for Clean and Safe Water 
address water quality and drinking water. The science priorities for 
Land Preservation and Restoration focus on improving characterization, 
measuring, and monitoring methods; enhancing methods and models for 
estimating ecological effects; reducing uncertainty in human health and 
ecological risks; and developing more cost-effective and reliable 
remediation and treatment technologies. The science priorities for 
Healthy Communities and Ecosystems are wide ranging and comprise a 
variety of priorities among multiple program offices, as well as basic 
research. The science priorities for Compliance and Environmental 
Stewardship are pollution prevention practices; new technology 
development; socioeconomics; and decisionmaking related to compliance, 
enforcement, incentives, monitoring, and innovative approaches to 
environmental stewardship. In addition, EPA has identified cross-
cutting science priorities that span several programs and help the 
Agency accomplish multiple science objectives. These are aggregate and 
cumulative risk assessment, genomics, computational toxicology, 
environmental indicators and susceptible subpopulations as high-
priority cross-cutting activities. Advances in these areas will improve 
EPA's capability to predict and reduce potential human health and 
ecological risks under all five of the Agency's goals.
 EPA's emphasis on economic and policy analysis supports the Agency's 
continuing dedication to quantifying the costs and benefits of its air, 
land and water regulations, policies and programs. In the coming year, 
EPA will expand its economic research programs to improve the 
measurement of environmental benefits, focusing on efforts to value the 
benefits of preserving goods and services provided by ecological 
systems. EPA will continue to undertake studies to quantify the social 
benefits and costs of established and new economically significant 
rules, including preparation of a revised comprehensive evaluation of 
the economic benefits and costs of programs established under the Clean 
Air Act.
Innovative Approaches
 Increasingly, EPA's regulations reflect innovative approaches that go 
beyond traditional technology-based standards and aim to improve 
performance and cut costs. Some of the innovations likely to influence 
EPA's regulations in fiscal year (FY) 2004 include market-based 
incentives that harness the power of economics to drive decisionmaking, 
flexible implementation options that provide regulated entities with 
more choices in deciding how to achieve an environmental goal, and 
information provisions that highlight environmental performance and 
provide an impetus for improvement. EPA will also support environmental 
technology innovation by allowing use of innovative technologies in its 
regulations. For example, through a national environmental technology 
competition, EPA is conducting demonstrations of innovative 
technologies for removing arsenic from drinking water to enable small 
drinking water systems to cost-effectively comply with EPA's new 
standards. The first twelve of over twenty planned demonstrations will 
begin by December 2003.
 Another innovative approach for achieving environmental results is 
fostering voluntary action. Today EPA manages a suite of voluntary 
programs, such as WasteWise and Energy Star, that help organizations 
achieve measurable environmental improvements. While these programs are 
designed to support efforts to reduce pollution in ways that are not 
required by regulation, they often have the secondary effect of 
improving the quality of regulations. For example, by working closely 
with trade associations and other organizations, EPA has been able to 
develop regulations that meet environmental goals while also being 
responsive to special needs, interests, and circumstances surrounding a 
particular issue. Given the potential to improve the quality of 
regulations and, in some cases, to eliminate the need for regulation 
altogether, EPA will continue to promote and support development of 
voluntary programs.
 Regulatory flexibility, cost reduction, information transfer, and 
technology development are all objectives fueling EPA's innovation 
investments. However, before any innovation is adopted, EPA conducts 
pilot tests to ensure feasibility and evaluate the results. In the 
coming year, EPA will explore innovative approaches in cooperation with 
many partners. In particular, EPA will work with States through the 
Joint Agreement on Regulatory Innovation, the newly established State 
Innovation Grant program, and other mechanisms. To realize the greatest 
value from each innovation, EPA will also work to expand use of proven 
innovations on the broadest possible scale. This includes working with 
States to apply Massachusetts's highly successful Environmental Results 
Program to improve environmental compliance and accountability among 
priority small business sectors.

[[Page 72556]]

Attention to Small Businesses
 Helping small businesses improve environmental performance is a top 
priority for EPA. EPA offers a variety of services for small 
businesses, including a toll-free hotline, a semiannual newsletter, 
online expert systems, and for some sectors, compliance assistance 
centers that focus on the unique environmental management issues facing 
specific industries. EPA also maintains a Small Business Ombudsman 
which provides a point of contact for small businesses and ensures 
compliance with the Small Business Paperwork Relief Act of 2002.
 In FY 2003, EPA updated its Small Business Strategy to unify its many 
small business services and help small businesses fulfill their 
environmental responsibilities. The strategy focuses on improving EPA's 
understanding of small business issues, and improving small businesses' 
understanding of EPA. The strategy also aims to involve small 
businesses earlier in the regulatory development process and to develop 
alternative regulatory approaches - such as self-certification 
procedures - that work better for small businesses. Other objectives 
include developing compliance tools to make it easier for small 
businesses to comply as well as rewards that recognize small businesses 
for their environmental stewardship.
 In FY 2004, EPA will focus on implementing the Small Business 
Strategy. By better coordinating small business activities, EPA aims to 
improve its technical assistance and outreach efforts, minimize burden 
to small businesses in its regulations, and simplify small businesses' 
participation in its voluntary programs.
 A number of rules included in this plan may be of particular interest 
to small businesses. The following are intended to provide regulatory 
relief:
Office of Solid Waste Burden Reduction Project Final Rule
Increase Metals Reclamation from F006 Waste Streams Proposed Rule
Standardized Permit for RCRA Hazardous Waste Management Facilities 
Final Rule
Recycling of Cathode Ray Tubes and Mercury-Containing Equipment: 
Changes to Hazardous Waste Regulations Final Rule
 Other rules in this plan may potentially have significant impacts on 
small businesses. They include:
Standards and Practices for Conducting ``All Appropriate Inquiry'' 
Proposed Rule
Groundwater Rule
Lead-Based Paint Activities: Training and Certification for Renovation 
and Remodeling
Effluent Guidelines and Standards for the Construction and Development 
Industry
Long-Term 2 Enhanced Surface Water Treatment Rule
Stage 2 Disinfection Byproducts Rule
Control of Emissions of Air Pollution from Nonroad Diesel Engines and 
Fuel
National Security
 EPA is one of many Federal agencies with responsibilities related to 
national security. This new priority is affecting the structure of 
EPA's programs, the Agency's budget, and its regulatory agenda. 
Virtually every office within EPA has had to extend its reach above 
EPA's core environmental mission to encompass this new priority. Some 
offices are working to prevent future terrorist attacks and enhance 
preparedness through the research of water and building security, and 
through teams devoted to counterterrorism law enforcement support, 
water and wastewater infrastructure protection, building air 
protection, food security, and information infrastructure security. 
Other programs have focused on improving various ways to respond in the 
event of an incident, including EPA's extensive emergency response 
network (including chemical, biological, and radiological emergency 
response), the EPA Emergency Operations Center, and National 
Decontamination Teams. These many activities highlight EPA's new 
priority and help to ensure that the nation is better protected and 
prepared for a terrorist event.
 As this new priority has such broad implications for the Agency, a 
need was seen by the Administrator for a central office to ensure that 
EPA's policies regarding terrorism incident preparedness and response 
promote efficiency, collaboration, and reduction of gaps. This new 
office formed in February 2003 as the Administrator's Office of 
Homeland Security (OHS), which has the major responsibilities of 
leading and coordinating homeland security activities and policy 
development across the Agency. The office is working to ensure that, 
while EPA continues to meet its core environmental protection mission, 
the Agency is also evolving to meet its homeland security 
responsibilities, assuring that EPA's new priority receives the 
necessary attention.
HIGHLIGHTS OF EPA'S REGULATORY PLAN
Office of Air and Radiation
 The principal regulatory priority of EPA's Office of Air and Radiation 
(OAR) for FY 2004 is to protect public health and the environment from 
the harmful effects of fine particulate matter and ozone, the two air 
pollutants that persist widely in the Nation's air in amounts that 
exceed Clean Air Act health standards. Exposure to these pollutants is 
associated with numerous harmful effects on human health, including 
respiratory problems, heart and lung disease, and premature death. OAR 
is also continuing with priority efforts to address cancer-causing air 
toxics pollution by implementing a toxics-control program under the 
Clean Air Act. OAR is also working to increase the effectiveness and 
efficiency of its permitting programs, which are the main mechanisms 
through which these protections are implemented. These efforts are 
described briefly below.
 OAR's principal vehicle to address the continuing problem of 
particulate and ozone pollution is the Clear Skies legislative 
proposal, which would achieve large reductions in the emissions that 
cause particulate and ozone pollution through use of a ``cap-and-
trade'' system similar to the one that has proved so successful in 
EPA's Acid Rain program. This pollution, largely from electric 
powerplants and large industrial boilers, is transported on the wind 
over long distances from the Midwest to the east coast, and is a major 
factor in the pollution problems of eastern cities. The plan also 
describes a rulemaking to address emissions of off-road vehicles, which 
are significant sources of ozone and particulate pollution. Nonroad 
engines are used in construction equipment and other vehicles that do 
not normally travel on roads and highways. The nonroad rule will set 
new emission standards for these engines, and will also greatly lower 
the amount of sulfur in diesel fuel, which will reduce sulfur pollution 
in the air and also ensure that the engines' pollution controls are not 
prevented from working properly by being ``fouled'' with high-sulfur 
fuel.
 EPA continues to address toxic air pollution under authority of the 
Clean Air Act Amendments of 1990 by implementing the Maximum Achievable 
Control Technology (MACT) program, which has the goal of controlling 
toxic air pollution from major emitters nationwide. Toxic air pollution 
is a term that covers a large number of industrial chemicals and other 
substances that

[[Page 72557]]

have been shown to cause cancer, birth defects, and developmental 
problems in children. To date, EPA's air toxics program has focused 
primarily on reducing emissions from large industrial sources, such as 
petroleum refineries and chemical manufacturing plants, through 
technology-based standards. When fully implemented, the overall MACT 
program will reduce more than one million tons of toxic air emissions 
per year. The rules listed in this year's Regulatory Plan-covering 
electric utilities, industrial boilers, institutional/commercial 
boilers, wood manufacturing, reciprocating engines, 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.
 Since many air quality programs are administered through permitting 
programs, OAR continues to work toward improving these programs to 
increase efficiency and reduce regulatory burden. Currently, OAR is 
developing several rulemakings to streamline and improve its two 
principal permitting programs. The first effort, to revise the New 
Source Review program, will clarify the circumstances under which 
companies must obtain construction permits before building new 
facilities or significantly modifying existing facilities. These 
revisions will provide more regulatory certainty by clarifying 
compliance requirements, and will also make the program easier to 
administer while maintaining its environmental benefits. The second 
effort will streamline and simplify the Operating Permits program, 
which requires that all operating facilities have a valid permit 
assuring that they meet all applicable air-pollution regulations. In 
both cases, OAR is drawing upon many years of intense involvement with 
major stakeholders, who have helped shape a suite of reforms that are 
expected to both improve the environmental effectiveness of these 
programs and make them easier to comply with.
 The annual report on the costs and benefits of regulations, entitled 
Stimulating Smarter Regulation: 2002 Report to Congress on the Costs 
and Benefits of Regulations and Unfunded Mandates on State, Local, and 
Tribal Entities, that is prepared by the Office of Management and 
Budget (OMB) and submitted to Congress each year, included several 
nominations for reform from the public. In FY 2004, OAR expects to 
address through regulatory action one of the areas raised: New Source 
Review (Comments 16, 30, 77, 187, 188, 189, and 196). (For a 
copy of these comments, go to OMB's compilation of the comments at 
http://www.whitehouse.gov/omb/inforeg/key--comments.html.)
Office of Water
 EPA's Office of Water has established five regulatory priorities for 
the coming year. They include rules affecting cooling water intakes, 
industrial and municipal wastewater pollution, the Total Maximum Daily 
Load (TMDL) Program, and drinking water.
 EPA intends to issue a final rule to control the adverse environmental 
impacts associated with cooling water intakes. Many power plants and 
factories withdraw large volumes of water from rivers, lakes, or other 
water bodies to cool their production equipment. As required by the 
CWA, EPA must ensure that the location, design, construction, and 
capacity of these cooling water intake structures reflect the best 
technology available for minimizing adverse environmental impact. EPA 
intends to issue a final rule addressing cooling water intake 
structures at large steam electric power plants. These facilities (and 
to a small degree, household ratepayers) will bear the costs of this 
rule. 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 regulations to help control industrial and 
municipal wastewater pollution. EPA expects to issue final effluent 
guidelines that would reduce the discharge of pollutants contained in 
storm water runoff from construction sites. These requirements are 
expected to result in significant improvements in water quality as a 
result of construction site owners and operators using best management 
practices.
 EPA plans to propose a rule establishing a new framework for 
accomplishing the water quality planning and management provisions of 
the 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 proposed new framework seeks to increase TMDL 
program flexibility, enhance stakeholder participation, promote 
opportunities for trading, and increase efficiencies in establishing, 
approving, and implementing TMDLs.
 Finally, EPA is developing three rules to protect the safety of 
drinking water. First, EPA is developing a final Long-Term 2 Enhanced 
Surface Water Treatment Rule (LT2ESWTR). This rule would 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 unfiltered systems. Second, EPA plans to finalize 
the Groundwater Rule, a rule that addresses fecal contamination in 
public water systems served by groundwater sources. Finally, EPA is 
developing a final 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; bladder, colon, and rectal cancer; 
and possible reproductive and developmental health effects.
Office of Prevention, Pesticides, and Toxic Substances
 Evidence suggests that environmental exposure to man-made chemicals 
that mimic hormones (endocrine disruptors) may cause adverse health 
effects in human and wildlife populations. The Food Quality Protection 
Act directed EPA to develop a chemical screening program (the Endocrine 
Disruptor Screening Program, EDSP), using appropriate validated test 
systems and other scientifically relevant information, to determine 
whether certain substances may have hormonal effects in humans. EPA is 
implementing recommendations from a scientific advisory committee, 
which was established to advise EPA on the EDSP, by developing and 
validating test systems for determining whether a chemical may have 
effects similar to those produced by naturally occurring hormones. As 
part of this program EPA is also designing a framework for procedures 
and processes to use when implementing the EDSP, and is

[[Page 72558]]

developing an initial list of chemicals for which testing will be 
required. A proposed chemical selection approach for this initial list 
of chemicals was published in the Federal Register in December 2002 for 
public comment, and the comment period ended April 1, 2003. A notice on 
the final approach is expected to be published in early 2004.
 To address high production volume (HPV) chemicals, the Agency launched 
the HPV Initiativein April 1998, which is a data collection and 
development program established by OPPTS for existing U.S. HPV 
chemicals. Under this initiative, HPV chemicals are defined as organic 
chemicals manufactured (including imported) at or above 1 million 
pounds per year based on information submitted under the 1990 Inventory 
Update Rule established pursuant to the Toxic Substances Control Act 
(TSCA). Through the HPV Initiative, which includes a voluntary 
component (the HPV Challenge Program) for certain international efforts 
and rulemaking under TSCA, basic screening level hazard datanecessary 
to provide critical information about the environmental fate and 
potential hazards associated with HPV chemicals will be collected or, 
where necessary, developed. Data collected and/or developed under the 
HPV Initiative will provide critical basic information about the 
environmental fate and potential hazards associated with these 
chemicals which, when combined with information about exposure and 
uses, will allow the Agency and others to evaluate and prioritize 
potential health and environmental effects and take appropriate follow 
up action. Of the estimated 2,800 HPV chemicals included in the HPV 
Initiative, under the voluntary HPV Challenge Program component, EPA 
received commitments from 338 companies individually or through 
consortia and the International Council of Chemical Associations (ICCA) 
to sponsor 2,165. As of August 2003, EPA has received 225 test plans 
covering 1,055 chemicals either individually or as part of a chemical 
category. EPA plans to issue a final rule to require testing for a 
number (30 or so) of the HPV chemicals that were not sponsored as part 
of the voluntary HPV Challenge Program.
 Childhood lead poisoning is a pervasive problem in the United States, 
with almost a million young children having more than 10 ug/dl of lead 
in their blood (Center for Disease Control's level of concern). 
Although there have been dramatic declines in blood-lead levels due to 
reductions of lead in paint, gasoline and various food sources, 
remaining lead-based paint in older houses continues to be a 
significant source of childhood lead poisoning. Section 402(c) of the 
Toxic Substances Control Act (TSCA) directs EPA to address renovation 
and remodeling activities in these older houses by first conducting a 
study of the extent to which persons engaged in various types of 
renovation and remodeling activities are exposed to lead in the conduct 
of such activities or disturb lead and create a lead-based paint hazard 
on a regular basis. Section 402(c) further directs the Agency to revise 
the lead-based paint activities regulations (40 CFR part 745 subpart L) 
to include renovation or remodeling activities that create lead-based 
paint hazards. In order to determine which contractors are engaged in 
such activities, the Agency is directed to utilize the results of the 
study and consult with the representatives of labor organizations, 
lead-based paint activities contractors, persons engaged in remodeling 
and renovation, experts in health effects, and others. Given the 
significant number of older houses affected, such a rule is likely to 
have a potentially significant economic impact. In an effort to 
minimize that impact, the Agency is working with stakeholders to 
explore the development of non-rulemaking approaches for reducing the 
potential creation of lead-based paint hazards from renovation or 
remodeling activities. The lead-based paint program activities are 
intended to insure that the individuals and firms conducting lead-based 
paint activities will do so in a way that safeguards the environment 
and protects the health of building occupants, especially children 
under six years old.
 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 has already 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 in its applicability.
 EPA anticipates it will develop a policy or regulation setting forth 
criteria and standards the Agency would use in deciding the extent to 
which it will rely on certain kinds of human research to support its 
actions to protect public health and the environment. In developing a 
future policy or rule, EPA will consider the public comments received 
in response to the advance notice of proposed rulemaking published in 
the Federal Register on May 7, 2003 (68 FR 24410), and will also 
carefully consider advice from the National Academy of Sciences 
expected in December 2003. The policy or rule would establish rigorous 
scientific and ethical standards that EPA would apply in its analysis 
of various types of research involving people exposed to toxicants to 
identify or quantify their effects. The Agency will particularly focus 
on ``third-party intentional dosing human studies,'' but recognizes 
that standards applicable to these studies may also be applicable to 
other types of studies. ``Third party studies'' refers to research not 
conducted or supported by EPA or other federal agencies, and therefore 
not governed by the regulation for Protection of Human Subjects, widely 
referred to as the Common Rule (40 CFR part 26).
Office of Solid Waste and Emergency Response
 The Office of Solid Waste and Emergency Response (OSWER) has a number 
of regulatory priorities aimed at improving environmental quality. 
Protection of public health and the environment and environmental 
stewardship are two key themes, as is reducing burden on the regulated 
community where environmental protections are maintained.
 During the 1990s, EPA determined that additional control is needed for 
cement kiln dust, a high-volume byproduct material of the cement 
manufacturing process that potentially contains hazardous constituents, 
such as lead, cadmium and chromium. EPA also committed to develop 
regulations that would be tailored to protect human health and the 
environment while limiting burden on the regulated community. EPA 
proposed a comprehensive set of standards for the management of cement 
kiln dust in 1999, and plans to finalize standards soon.
 Likewise, in response to an earlier determination that coal combustion 
wastes could pose significant risks to human health and the environment 
if they are not properly managed, EPA is developing standards for the 
management of coal combustion wastes generated by commercial electric 
power producers. When implemented, the standards will prevent 
contamination or damage to groundwaters and surface waters.

[[Page 72559]]

 EPA will further promote and protect air quality by reducing emissions 
of arsenic, beryllium, cadmium, chromium, dioxins and furans, hydrogen 
chloride, lead, manganese, and mercury, all of which cause adverse 
health effects. EPA plans to propose national emission standards for 
these hazardous air pollutants for hazardous waste combustors. This 
proposal will also contain a response to the Cement Kiln Recycling 
Coalition petition of the Administrator to withdraw Agency policy and 
technical guidance concerning site-specific risk assessments for 
hazardous waste combustors and re-issue them as regulations, if EPA 
continues to believe that they are necessary. This proposal also 
supports a reform nomination for site-specific risk assessments in the 
Resource Conservation and Recovery Act (RCRA) that was mentioned in 
OMB's 2002 Report to Congress on the Costs and Benefits of Regulations.
 EPA is determining whether wastes from the manufacturing of dyes and 
pigments present a hazard to human health and the environment. If so, 
EPA will propose their listing under RCRA subtitle C.
 OSWER's Environmental Stewardship priority promotes revitalizing the 
land, including cleaning up and redeveloping Brownfields. The Small 
Business Liability Relief and Brownfields Revitalization Act addresses 
the need for bona fide prospective purchasers, contiguous property 
owners, and innocent landowners to conduct ``all appropriate inquiry'' 
into prior ownership and use of the property at the time the party 
acquires the property. EPA is seeking to provide purchasers of 
contaminated property with clarity regarding the procedures and 
standards for conducting an ``all appropriate inquiry'' so as to limit 
CERCLA liability.
 To further promote environmental stewardship, EPA is encouraging 
recycling. One of the largest hazardous waste streams amenable to 
recycling is the wastewater treatment sludges from electroplating 
operations (waste code F006). EPA is considering changes to the 
existing RCRA regulations to encourage safe recycling and waste 
management practices of wastewater treatment sludges from 
electroplating operations. These electroplating sludges are 
sufficiently high in metal(s) and sufficiently low in other toxic 
constituents.
 EPA also seeks to remove unnecessary regulatory barriers to recycling 
of Cathode Ray Tubes. These tubes, which are found in televisions and 
computer monitors, contain lead to protect users from X-rays.
 To reduce burden on the regulated community, Agency efforts are 
underway to eliminate duplicative and non-essential paperwork burden 
imposed by RCRA reporting and recordkeeping requirements. This rule 
will eliminate or streamline paperwork requirements that are 
unnecessary because they add little to the protectiveness of the RCRA 
regulations.
 EPA also intends to reduce burden on the regulated community by 
revising the current RCRA regulations that apply to the wastewater 
treatment sludges from the chemical conversion coating (zinc 
phosphating) of aluminum. The current Federal regulations require that 
the wastewater treatment sludges generated from this conversion coating 
process be managed as a RCRA hazardous waste. Yet, such sludges do not 
contain the constituents for which the F019 hazardous waste was 
originally listed (cyanide and chromium).
 EPA also plans to streamline both the RCRA permit and hazardous waste 
manifest processes. The Agency is creating a standardized permit for 
RCRA facilities that generate hazardous 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.
 Likewise, the Agency plans to reduce paperwork burden by standardizing 
the Uniform Hazardous Waste Manifest, which is a multi-copy form used 
to identify the quantity, composition, origin, routing, and destination 
of RCRA hazardous waste during its transportation. EPA plans to specify 
one format for the manifests that may be used in all States. EPA is 
working toward standard requirements for tracking rejected wastes, 
container residues, and international shipments of hazardous wastes.
Office of Environmental Information
 The top regulatory priority of EPA's Office of Environmental 
Information (OEI) will be to finalize the Cross-Media Electronic 
Reporting and Recordkeeping 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 will remove existing regulatory obstacles 
to electronic reporting, and it will set requirements for companies 
choosing to report electronically. In addition, this rule will 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 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 2004. 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, EPA has implemented an integrated system to support the 
electronic reporting needs of EPA media programs, known as Central Data 
Exchange (CDX). CDX currently provides electronic reporting services to 
more than 14,000 users in six major media programs and is on track to 
provide electronic reporting services for all significant environmental 
data collections over the next two years. All but one of the major 
environmental data exchanges with States will be operational through 
CDX by the end of 2004, and the outstanding data exchange will be 
operational by the end of FY 2005. In addition, beginning in the spring 
of 2002, Toxics Release Inventory (TRI) reporters were able to useTRI - 
Made Easy (TRI-ME) software to submit their forms electronically over 
the Internet through CDX. However, reporters still had to submit a 
paper certification letter. Beginning in the spring of 2003, TRI 
reporters no longer need to submit paper certification letters; 
instead, they are now able to use the TRI-ME software to submit data 
over

[[Page 72560]]

the Internet using CDX with electronic signature.
_______________________________________________________________________
EPA

                              -----------

                             PRERULE STAGE

                              -----------

101. 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 of the 
Program EPA 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 a priority 
setting approach to be used by the Agency to identify the initial list 
of chemicals for which tier 1 testing will be required. On December 30, 
2002, EPA published in the Federal Register for public comment a 
proposed chemical selection approach for this initial list of 
chemicals. The public comment period on this proposed approach was 
extended to April 1, 2003 in a Federal Register notice dated February 
26, 2003. Following consideration of comments on this proposed 
approach, EPA will issue a Federal Register notice setting forth its 
final approach. Although this action is not a rulemaking, the Agency 
has included it in the Regulatory Agenda to help inform the public.


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 require testing of 
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 a endocrine mediated 
pathway. Preliminary studies show decreases on IQ tests and increases 
in aggression in children. Severe malformations of the genitals of boys 
has increased steadily over the last two decades. Wildlife effects have 
been more thoroughly documented. Abnormalities in birds, marine 
mammals, fish and shellfish have been documented in the United States, 
Europe, Japan, Canada, and Australia which have been linked to specific 
chemical exposures. Evidence is sufficient for the United States to 
proceed on a two track strategy: research on the basic science 
regarding endocrine disruption and screening to identify which 
chemicals are capable of interacting with the endocrine system. The 
combination of research and test data developed by this program will 
enable EPA to take action to reduce chemical risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice RfC      67 FR 79611                                    12/30/02
Notice ECP      68 FR 8901                                     02/26/03
Notice Final                                                   03/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


SAN 4727.


Split from RIN 2070-AD26.


Agency Contact:
Mary Belefsk
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 202-566-1212
Fax: 202 564-8452
Email: [email protected]

Gary Timm
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Washington, DC 20460
Phone: 202-564-8474
Fax: 202 564-8482
Email: [email protected]
RIN: 2070-AD59
_______________________________________________________________________
EPA

                              -----------

                          PROPOSED RULE STAGE

                              -----------

102. ELECTRIC UTILITY STEAM GENERATING UNIT MACT REGULATION
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


42 USC 7412

[[Page 72561]]

CFR Citation:


40 CFR 63


Legal Deadline:


NPRM, Judicial, December 15, 2003, NPRM.


Final, Judicial, December 15, 2004, Final.


Abstract:


In December 2000, the EPA determined that regulation of hazardous air 
pollutant emissions (HAP) from oil- and coal-fired electric utility 
steam generating units was necessary and appropriate. This finding was 
based on the results of the study mandated by section 112(n)(1)(A) of 
the Clean Air Act, as amended. The regulation(s) will be developed 
under section 112 and will result in standards based on the use of 
maximum achievable control technology (MACT). The primary benefit will 
be the reduction of mercury emissions to the atmosphere from coal-fired 
units but other HAP will also be reduced. Small businesses and State/
local/tribal governments could be impacted (particularly those 
governments owning or operating oil- or coal-fired electric generation 
facilities).


Statement of Need:


Oil and coal-fired electric utility steam generating units were added 
(December 20, 2000) to the list of source categories to be regulated 
under section 112 of the Clean Air Act, as amended.


Summary of Legal Basis:


Section 112 of the Clean Air Act, as amended.


Alternatives:


Alternatives will be identified as the proposal is developed.


Anticipated Cost and Benefits:


It is anticipated that this rule will result in significant costs to 
the affected industry, including Federal, State, and local entities 
that own/operate electric utility steam generating units. These costs 
will be identified as the proposal is developed.


Risks:


Risk information will become available as the proposal is developed.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN 4571.


Sectors Affected:


221112 Fossil Fuel Electric Power Generation


Agency Contact:
Robert Wayland
Environmental Protection Agency
Air and Radiation
C-439-01
Research Triangle Park, NC 27711
Phone: 919 541-1045
Fax: 919 541-5450
Email: [email protected]

William 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-AJ65
_______________________________________________________________________
EPA
103. IMPLEMENTATION RULE FOR PM-2.5 NAAQS
Priority:


Other Significant


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


42 USC 7410; 42 USC 7501 et seq


CFR Citation:


40 CFR 51


Legal Deadline:


None


Abstract:


In 1997, EPA promulgated revised National Ambient Air Quality Standards 
(NAAQS) for fine particulate matter (PM-2.5). The rule described in 
this paragraph--the Implementation Rule for PM-2.5 NAAQS--will include 
requirements and guidance for State and local air pollution agencies to 
develop and submit State implementation plans (SIPs) designed to bring 
the areas into attainment with the 1997 standards. These SIP-
development activities include conducting technical analyses to 
identify effective strategies for reducing emissions contributing to 
PM-2.5 levels, and adopting regulations as needed in order to attain 
the standards. Ambient air quality monitoring for 1999-2001 shows that 
areas exceeding the standards are located throughout the eastern half 
of the United States and in California. Estimates show that compliance 
with the standards will prevent thousands of premature deaths from 
heart and lung disease, tens of thousands of hospital admissions and 
emergency room visits, and millions of absences from school and work 
every year.


Statement of Need:


This rule is needed in order to provide guidance to State and local 
agencies in preparing State implementation plans (SIPs) designed to 
bring areas into attainment with the 1997 PM-2.5 standards. The 
implementation requirements for nonattainment areas are generally 
described in subpart 1 of section 172 of the Clean Air Act. This rule 
provides further interpretation of those requirements for the PM-2.5 
standards.


Summary of Legal Basis:


42 USC 7410 and 42 USC 7501 et seq.


Alternatives:


Alternatives will be explored as the proposal is developed.


Anticipated Cost and Benefits:


This information will be provided as the proposal is developed.


Risks:


The risks addressed by this rule are those addressed by the 1997 NAAQS 
rule--i.e., the health and environmental risks associated with 
nonattainment of the NAAQS. These risks were summarized in detail in 
the analyses accompanying the 1997 NAAQS rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/03
Final Action                                                   12/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal, Local, State, Tribal

[[Page 72562]]

Additional Information:


SAN 4752.


Agency Contact:
Richard Damberg
Environmental Protection Agency
Air and Radiation
C504-02
Research Triangle Park, NC 27711
Phone: 919 541-5592
Fax: 919 541-5489
Email: [email protected]

Joe Paisie
Environmental Protection Agency
Air and Radiation
C504-02
Washington, DC 20460
Phone: 919-541-5556
Email: [email protected]
RIN: 2060-AK74
_______________________________________________________________________
EPA
104. [bull] PREVENTION OF SIGNIFICANT DETERIORATION (PSD) AND 
NONATTAINMENT NEW SOURCE REVIEW (NSR): ALLOWABLES PLANTWIDE 
APPLICABILITY LIMIT (PAL), AGGREGATION, AND DEBOTTLENECKING
Priority:


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


Legal Authority:


42 USC 7401 et seq


CFR Citation:


40 CFR 51.165; 40 CFR 51.166; 40 CFR 52.21


Legal Deadline:


None


Abstract:


EPA recently promulgated NSR rules for a Plantwide Applicability Limit 
(PAL) based on actual emissions that applies to existing major 
stationary sources. This year, EPA will propose an allowables PAL 
provision based on a facility's allowable emissions. If a company 
commits to keep its facility emissions below Allowables PAL level, then 
these regulations will allow the plant owners to avoid the NSR 
permitting process when they make changes at individual units at the 
plant, as long as the total emissions from the facility will not 
increase. This package will also include an aggregation provision which 
will propose that, for the purposes of NSR applicability, a project is 
considered separate and independent from any other project unless the 
project is dependent upon another project to be economically or 
technically viable, or if the project is intentionally split from other 
projects to avoid NSR. The package will also include a debottlenecking 
provision which addresses emissions from units that change as a result 
of a physical or operational change to another unit at the facility. 
EPA will propose that, when calculating actual emissions associated 
with a physical change or change in the method of operation, sources 
generally should look only at the unit undergoing the change. Emissions 
from units ``upstream'' or ``downstream'' of the unit being changed 
should be considered only when the permitted emissions limit of the 
upstream or downstream unit would be exceeded or increased as a result 
of the change.


Statement of Need:


The current New Source Review program provides for emissions from 
multiple projects to be aggregated (aggregation) as one single project 
under certain circumstances. Similarly, when making a PSD applicability 
calculation, emissions from units whose effective capacity and 
potential to emit have been increased as a result of a modification to 
another unit (debottlenecked units), must be included in the initial 
PSD applicability calculations. Specific questions regarding the 
application of these two terms have been addressed on a case-by-case 
basis. By completing this rulemaking, regulated entities and regulatory 
agencies will be provided an additional level of certainty in 
addressing applicability issues. We recently promulgated NSR rules for 
a Plantwide Applicability Limit (PAL) based on actual emissions that 
applies to existing major stationary sources. In 2003, we will propose 
an allowables PAL based on a facility's allowable emissions mainly for 
greenfield sources. If a company commits to keep its facility emissions 
below Allowables PAL level, then these regulations will allow the plant 
owners to avoid the NSR permitting process when they make changes at 
individual units at the plant, as long as the total emissions from the 
facility will not increase. This would provide flexibility for sources 
to respond rapidly to market changes without compromising environmental 
protection.


Summary of Legal Basis:


42 USC 7411(a)(4)


Alternatives:


Alternatives will be developed as the rulemaking proceeds.


Anticipated Cost and Benefits:


Cost and benefit information will be developed as appropriate as the 
rulemaking proceeds.


Risks:


Risk information will be developed as appropriate as the rulemaking 
proceeds.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/03
Final Action                                                   08/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN 4793.


Agency Contact:
Lynn Hutchinson
Environmental Protection Agency
Air and Radiation
C339-03
Research Triangle Park, NC 27711
Phone: 919-541-5795
Fax: 919 541-5509
Email: [email protected]

Raj Rao
Environmental Protection Agency
Air and Radiation
C339-03
Washington, DC 20460
Phone: 919-541-5344
Fax: 919 541-5509
Email: [email protected]
RIN: 2060-AL75
_______________________________________________________________________
EPA
105. LEAD-BASED PAINT ACTIVITIES; TRAINING AND CERTIFICATION FOR 
RENOVATION AND REMODELING
Priority:


Other Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


15 USC 2682 TSCA 402

[[Page 72563]]

CFR Citation:


40 CFR 745


Legal Deadline:


Final, Statutory, October 28, 1996.


Abstract:


Under section 402(c)(2) of the Toxic Substances Control Act (TSCA) 
title IV, EPA conducted a study of the extent to which persons engaged 
in renovation and remodeling activities in target housing are exposed 
to lead in the conduct of such activities or disturb lead and create a 
lead-based paint hazard. EPA must use the results of this study and 
consult with interested parties to determine which categories of 
renovation and remodeling activities require training and 
certification. EPA must then revise the training and certification 
regulations originally developed for individuals performing lead-based 
paint abatement under section 402(a) of TSCA title IV to apply them to 
the renovation and remodeling categories. If EPA determines that any 
category does not require certification, EPA must publish an 
explanation of the basis for that determination.


Statement of Need:


Childhood lead poisoning is a pervasive problem in the United States, 
with almost a million young children having more than 10 ug/dl of lead 
in their blood, (Center for Disease Control's level of concern). 
Although there have been dramatic declines in blood-lead levels due to 
reductions of lead in paint, gasoline, and food sources, remaining 
paint in older houses continues to be a significant source of childhood 
lead poisoning. These rules will help insure that individuals and firms 
conducting lead-based paint activities will do so in a way that 
safeguards the environment and protects the health of building 
occupants, especially children under 6 years old.


Summary of Legal Basis:


This regulation is mandated by TSCA section 402(c). TSCA section 402(c) 
directs EPA to address renovation and remodeling activities by first 
conducting a study of the extent to which persons engaged in various 
typed of renovation and remodeling activities are exposed to lead in 
the conduct of such activities or disturb lead and create a lead-based 
paint hazard on a regular basis. Section 402(c) further directs the 
Agency to revise the lead-based paint activities regulations (40 CFR 
part 745 subpart L) to include renovation or remodeling activities that 
create lead-based paint hazards. In order to determine which 
contractors are engaged in such activities the Agency is directed to 
utilize the results of the study and consult with the representatives 
of labor organizations, lead-based paint activities contractors, 
persons engaged in remodeling and renovation, experts in health 
effects, and others.


Alternatives:


TSCA section 402(c) states that should the Administrator determine that 
any category of contractors engaged in renovation or remodeling does 
not require certification; the Administrator may publish an explanation 
of the basis for that determination.


Anticipated Cost and Benefits:


EPA's quantitative cost estimates fall into four categories: Training 
Costs, Work Practice Costs, Clearance Testing Costs, and Administrative 
Costs. The estimates vary depending upon the option selected. In most 
cases we expect that requirements related to Clearance Testing and Work 
Practices will contribute the most to overall rule cost. The benefits 
analysis will not provide direct quantitative measures of each (or any) 
option. EPA does not have a complete risk assessment (with dose-
response functions) that would permit direct quantitative estimates. We 
do have other data, such as estimated loadings of Pb generated by 
renovation work, number and type of renovation events, demographics of 
the exposed population, and the costs of various health effects 
previously linked to Pb exposure. With the available information we are 
able to utilize several qualitative approaches to frame the benefits 
associated with an effective renovation rule.


Risks:


These rules are aimed at reducing the prevalence and severity of lead 
poisoning, particularly in children. The Agency has concluded that many 
R&R work activities can produce or release large quantities of lead and 
may be associated with elevated blood lead levels. These activities 
include, but are not limited to: sanding, cutting, window replacement, 
and demolition. Lead exposure to R&R workers appears to be less of a 
problem than to building occupants (especially young children). Some 
workers (and homeowners) are occasionally exposed to high levels of 
lead. Any work activity that produces dust and debris may create a lead 
exposure problem.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           10/00/04
Final Action                                                   10/00/06
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 Undetermined


Additional Information:


SAN 3557.


Sectors Affected:


23599 All Other Special Trade Contractors; 23551 Carpentry Contractors; 
53111 Lessors of Residential Buildings and Dwellings; 23322 Multifamily 
Housing Construction; 23521 Painting and Wall Covering Contractors; 
531311 Residential Property Managers; 23321 Single Family Housing 
Construction; 54138 Testing Laboratories


Agency Contact:
Mike Wilson
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
1200 Pennsylvania Ave
Washington, DC 20460
Phone: 202-566-0521
Fax: 202 566-0471
Email: [email protected]

Julie Simpson
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404T
Washington, DC 20460
Phone: 202-566-1980
Fax: 202 566-0471
Email: [email protected]
RIN: 2070-AC83
_______________________________________________________________________
EPA
106. PESTICIDES; EMERGENCY EXEMPTION PROCESS REVISIONS
Priority:


Other Significant


Legal Authority:


7 USC 136p; 7 USC 136w


CFR Citation:


40 CFR 166


Legal Deadline:


None

[[Page 72564]]

Abstract:


EPA will publish a Notice of Proposed Rulemaking in the Federal 
Register proposing several improvements to the pesticide emergency 
exemption process under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA). Two of these potential 
improvements are currently being tested through a limited pilot, and 
are based on recommendations from the States which are the primary 
applicants for emergency exemptions. EPA has established regulations 
under section 18 of FIFRA which allow a Federal or State agency to 
apply for an emergency exemption to allow an unregistered use of a 
pesticide for a limited time when such use is necessary to alleviate an 
emergency condition.


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, and expedite decisions 
on applications (which is critical in emergency situations).


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:


These procedural improvements are not expected to increase existing 
costs related to this program. In fact, this action is likely to 
provide reduced burden and cost to states and federal agencies that 
apply for emergency exemptions and reduced burden to EPA. Indirect 
benefits may accrue to users of pesticides under emergency exemptions 
if changes result in faster review and approval, or greater 
availability of pesticides. Although not required, EPA expects to 
assess the potential economic impacts of this action.


Risks:


In general, the measures being considered are primarily intended to 
reduce burdens for States and EPA and achieve efficiencies in the 
program. No impact on risk is anticipated.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Notice          68 FR 20145                                    04/24/03
NPRM                                                           04/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN 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 Frane
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703 305-5944
Email: [email protected]
RIN: 2070-AD36
_______________________________________________________________________
EPA
107. ACCEPTABILITY OF RESEARCH USING HUMAN SUBJECTS
Priority:


Other Significant


Legal Authority:


5 USC 301; 7 USC 136a; 7 USC 136w; 15 USC 2603; 21 USC 346a; 42 USC 
300v-1(b); 42 USC 7601; 33 USC 1361; 42 USC 9615; 42 USC 11048; 42 USC 
6912; 42 USC 300j-9


CFR Citation:


40 CFR 26 (Revision)


Legal Deadline:


None


Abstract:


EPA is evaluating its current policy with respect to the protection of 
human research subjects in testing not conducted or supported by the 
Federal government. Current EPA regulations in 40 CFR part 26 apply to 
research conducted or supported by the Agency or ``otherwise subject to 
regulation.'' No action has been taken yet to give effect to the 
``otherwise subject to regulation'' phrase. In addition, EPA has asked 
the advice of the National Academy of Sciences (NAS) on several issues 
surrounding the acceptability and interpretation of third party studies 
involving deliberate dosing of human subjects for the purpose of 
defining or quantifying toxic endpoints. EPA will seek public comment 
on issues related to Agency use of human research data in its 
regulatory decisionmaking. EPA believes the process being initiated 
will serve two important Agency goals: ensuring the availability of 
sound and appropriate scientific data in its decisions, and protection 
of the interests, rights and safety of human research subjects. EPA may 
issue one or more documents, which may include policy statements, 
rulemaking or requests for public comment.


Statement of Need:


In July 1998, the Agency committed that EPA would not consider human 
research in its regulatory decisions unless a policy were in place that 
could assure any such studies met the highest scientific and ethical 
standards. The Agency convened a special joint subcommittee of the 
FIFRA Scientific Advisory Panel and the EPA Science Advisory Board to 
advise on this policy. The subcommittee completed its report in 
September 2000. In December 2001 the Agency sought the advice of the 
National Academy of Sciences on several difficult issues. A report from 
the NAS is expected in December 2003. In December 2001 the Agency 
clarified its interim policy, committing, subject to certain 
exceptions, not to consider or rely on any third party studies 
involving intentional dosing of human

[[Page 72565]]

subjects with toxicants for the purpose of defining or quantifying 
their effects until a final policy is in place, and clarifying that 
this interim policy applies across all Agency programs. In June 2003, 
in response to a challenge of the interim policy, the U.S. Court of 
Appeals vacated the interim policy and stated that as a consequence of 
the Agency's ``previous practice of considering third party human 
studies on a case-by-case basis, applying statutory requirements, the 
Common Rule, and high ethical standards as a guide,'' was reinstated 
``until it is replaced by a lawfully promulgated regulation.'' If 
ultimately deemed acceptable for consideration, some human research 
could significantly affect the Agency's risk assessments of some 
pesticides and other toxicants.


Summary of Legal Basis:


Several statutes contain provisions that involve Agency regulatory 
decisions that are or may be based on testing not conducted or 
supported by the Agency. For example, FIFRA section 3 directs EPA to 
define data requirements supporting pesticide decisions and to 
establish guidelines for conducting research to support pesticide 
decisions; and FFDCA section 408 directs EPA to, among other things, 
consider available and reliable data in support of pesticide tolerance 
decisions. FIFRA sec. 4(g)(1) directs the Administrator to ``conduct a 
thorough examination'' of ``all data submitted under this section 
(section 4)'' and of ``all other available data found by the 
Administrator to be relevant.''


Alternatives:


Still to be identified.


Anticipated Cost and Benefits:


No analysis has been performed yet.


Risks:


No analysis has been performed yet.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
ANPRM           68 FR 24410                                    05/07/03
NPRM                                                           10/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Additional Information:


SAN 4610.


Sectors Affected:


32532 Pesticide and Other Agricultural Chemical Manufacturing


Agency Contact:
Bill Jordan
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
H-7501C
7501C
Washington, DC 20460
Phone: 703 305-1049
Fax: 703-308-4776
Email: [email protected]

John Carley
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7501C
Washington, DC 20460
Phone: 703-305-7019
Fax: 703-305-5060
Email: [email protected]
RIN: 2070-AD57
_______________________________________________________________________
EPA
108. 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. EPA 
may publish in the Federal Register the procedures and processes that 
the Agency 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 action 
will describe the authorities that EPA 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. 
section 346(a)(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

[[Page 72566]]

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, as a rough estimate, the screening battery is 
estimated to cost $200,000 per chemical. It is also too early to 
quantify the benefits of this program mathematically. The goal of the 
program is to reduce the risks identified in paragraph 22 below.


Risks:


Evidence is continuing to mount that wildlife and humans may be at risk 
from exposure to chemicals operating through a endocrine mediated 
pathway. Preliminary studies show decreases on IQ tests and increases 
in aggression in children. Severe malformations of the genitals of boys 
has increased steadily over the last two decades. Wildlife effects have 
been more thoroughly documented. Abnormalities in birds, marine 
mammals, fish and shellfish have been documented in the United States, 
Europe, Japan, Canada, and Australia which have been linked to specific 
chemical exposures. Evidence is sufficient for the United States to 
proceed on a two track strategy: research on the basic science 
regarding endocrine disruption and screening to identify which 
chemicals are capable of interacting with the endocrine system. The 
combination of research and test data developed by this program will 
enable EPA to take action to reduce chemical risks.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           07/00/04
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


SAN 4728. Split from RIN 2070-AD26. In August 2000, the Agency submited 
the required Status Report to Congress. In March 2002, the Agency 
submitted the requested status report to Congress on the Endocrine 
Disruptor Methods Validation subcommittee under the National Advisory 
Council on Environmental Policy and Technology.


Agency Contact:
Jane Smith
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7201M
Research Triangle Park, NC 27711
Phone: 919-380-4541
Fax: 202-564-8483
Email: [email protected]

Joe Nash
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202-564-8886
Fax: 202-564-4765
Email: [email protected]
RIN: 2070-AD61
_______________________________________________________________________
EPA
109. NESHAPS: STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR HAZARDOUS 
WASTE COMBUSTORS
Priority:


Other Significant


Legal Authority:


42 USC 6924 ``RCRA 3004''; 42 USC 6925 ``RCRA 3005''; 42 USC 7412 ``CAA 
112''; 42 USC 7414 ``CAA 114''


CFR Citation:


40 CFR 60; 40 CFR 63; 40 CFR 260; 40 CFR 264; 40 CFR 265; 40 CFR 266; 
40 CFR 270


Legal Deadline:


NPRM, Judicial, March 31, 2004.


Final, Judicial, June 15, 2005.


Abstract:


On September 30, 1999, EPA promulgated standards to control emissions 
of hazardous air pollutants from incinerators, cement kilns, and 
lightweight aggregate kilns that burn hazardous waste (referred to as 
the phase I rule). A number of parties, representing interests of both 
industry and the environmental community, sought judicial review of the 
rule. The Court ruled against EPA and vacated the phase I rule. On 
October 19, 2001, EPA, together with all petitioners, filed a joint 
motion asking the Court to stay the issuance of its mandate to allow 
them time to develop interim standards. These stop-gap interim 
standards were promulgated on February 13 and 14, 2002. They replace 
the vacated standards temporarily, until revised replacement standards 
are promulgated by June 15, 2005. This rulemaking will propose and 
finalize the Phase I replacement standards. Also, in this rulemaking 
effort, we are developing emission standards for hazardous waste 
burning industrial, institutional, commercial boilers, process heaters, 
and hydrochloric acid production furnaces. These sources are referred 
to as phase II sources because the standards were originally scheduled 
to be promulgated after phase I source standards were finalized; 
however, a separate consent decree now requires us to finish developing 
emission standards for the phase II sources by the same date as those 
for phase I (June 15, 2005). EPA is developing options for calculating 
the emission standards that are considered to be consistent with both 
the statutory requirements and the opinion of the Court. Potential 
costs and benefits are not yet available, because emission standards 
must be selected before the cost/benefit analyses begin.pI and phase II 
sources in December of 2003.


Statement of Need:


Section 112 of the Clean Air Act requires that the EPA promulgate 
regulations requiring the control of hazardous air pollutants from 
major and certain area sources. The control of hazardous air pollutants 
is achieved through promulgation of emission standards under sections 
112(d) and (f) and, in appropriate circumstances, work practice 
standards under section 112(h).


On September 30, 1999 EPA promulgated standards to control emissions of 
hazardous air pollutants from incinerators, cement kilns, and 
lightweight aggregate kilns that burn

[[Page 72567]]

hazardous waste (referred to as the phase I rule). A number of parties, 
representing interests of both industry and the environmental 
community, sought judicial review of the rule. The Court ruled against 
EPA and vacated the phase I rule.


Summary of Legal Basis:


On October 19, 2001, EPA, together with all petitioners, filed a joint 
motion asking the Court to stay the issuance of its mandate to allow 
time to develop interim standards. These stop-gap interim standards 
were promulgated on February 13 and 14, 2002. They replace the vacated 
standards temporarily, until revised replacement standards are 
promulgated by June 14, 2005. EPA is working towards promulgation by 
this date. EPA is also developing emission standards for hazardous 
waste burning industrial, institutional, commercial boilers, process 
heaters, and hydrochloric acid production furnaces. These sources are 
referred to as phase II sources because the standards were originally 
scheduled to be promulgated after phase I source standards were 
finalized; however, a separate consent decree now requires us to finish 
developing emission standards for the phase II sources by the same date 
as those for phase I (June 14, 2005).


Alternatives:


EPA is developing options for calculating the emission standards that 
are considered to be consistent with both the statutory requirements 
and the opinion of the Court.


Anticipated Cost and Benefits:


Potential costs and benefits are not yet available, because emission 
standards must be selected before the cost/benefit analyses can be 
completed. EPA plans to propose emission standards and compliance 
provisions for both the phase I and phase II sources in March 2004.


Risks:


For the 1999 rule, we estimated the avoided incidence of mortality and 
morbidity associated with reductions in particulate matter (PM) 
emissions. Estimates of cases of mortality and morbidity avoided were 
made for children and the elderly, as well as the general population, 
using concentration-response functions derived from human 
epidemiological studies. Morbidity effects included respiratory and 
cardiovascular illnesses requiring hospitalization, as well as other 
illnesses not requiring hospitalization, such as acute and chronic 
bronchitis and acute upper and lower respiratory symptoms. For this 
rule, we are comparing characteristics of the sources covered by the 
1999 rule to the sources covered by the replacement rule that are 
related to risk. These characteristics include emissions, stack 
characteristics, meteorology, and population. Based on the results of 
the statistical comparisons, we will infer whether the risks will be 
about the same, less than, or greater than the 1999 rule. Risk 
inferences for boilers and HCl production furnaces will be based on 
comparisons with incinerators for the 1999 rule.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM-CK         61 FR 17358                                    04/19/96
Final--Fasttrack63 FR 33782                                    06/19/98
Final--CK       64 FR 52828                                    09/30/99
NODA            65 FR 39581                                    07/27/00
DF 1            66 FR 35087                                    07/03/01
NPRM--Phase1    66 FR 35126                                    07/03/01
Parallel Proposa66 FR 35124                                    07/03/01
Direct Final Act66 FR 52361                                    10/15/01
Final Compliance66 FR 63313                                    12/06/01
Interim Final Ac67 FR 6792                                     02/13/02
Final HAP       67 FR 6968                                     02/14/02
NPRM                                                           03/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN 3333. For information on the Phase I portion of this effort, see 
SAN 4418, RIN 2050-AE79.


Sectors Affected:


3335 -; 3343 Audio and Video Equipment Manufacturing; 3251 Basic 
Chemical Manufacturing; 3273 Cement and Concrete Product Manufacturing; 
3271 Clay Product and Refractory Manufacturing; 3328 Coating, 
Engraving, Heat Treating and Allied Activities; 3342 Communications 
Equipment Manufacturing; 3341 Computer and Peripheral Equipment 
Manufacturing; 2211 Electric Power Generation, Transmission and 
Distribution; 45431 Fuel Dealers; 3332 Industrial Machinery 
Manufacturing; 3274 Lime, Gypsum and Gypsum Product Manufacturing; 3327 
Machine Shops, Turned Product, and Screw, Nut and Bolt Manufacturing; 
3362 Motor Vehicle Body and Trailer Manufacturing; 3361 Motor Vehicle 
Manufacturing; 3363 Motor Vehicle Parts Manufacturing; 2123 Non-
Metallic Mineral Mining and Quarrying; 3259 Other Chemical Product 
Manufacturing; 3329 Other Fabricated Metal Product Manufacturing; 3339 
Other General Purpose Machinery Manufacturing; 3279 Other Nonmetallic 
Mineral Product Manufacturing; 3255 Paint, Coating, Adhesive, and 
Sealant Manufacturing; 3253 Pesticide, Fertilizer and Other 
Agricultural Chemical Manufacturing; 3241 Petroleum and Coal Products 
Manufacturing; 4227 Petroleum and Petroleum Products Wholesalers; 3254 
Pharmaceutical and Medicine Manufacturing; 3231 Printing and Related 
Support Activities; 5629 Remediation and Other Waste Management 
Services; 3252 Resin, Synthetic Rubber, and Artificial and Synthetic 
Fibers and Filaments Manufacturing; 3344 Semiconductor and Other 
Electronic Component Manufacturing; 22132 Sewage Treatment Facilities; 
5622 Waste Treatment and Disposal


Agency Contact:
Rhonda Minnick
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703 308-8771
Fax: 703 308-8433
Email: [email protected]
RIN: 2050-AE01
_______________________________________________________________________
EPA
110. STANDARDS FOR THE MANAGEMENT OF COAL COMBUSTION WASTES GENERATED 
BY COMMERCIAL ELECTRIC POWER PRODUCERS
Priority:


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


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


42 USC 6907(a)(3); 42 USC 6944(a)


CFR Citation:


40 CFR 257


Legal Deadline:


None

[[Page 72568]]

Abstract:


This action is for the development of nonhazardous waste regulations 
under subtitle D of the RCRA statute. The regulations will apply to 
landfill and surface impoundment facilities that manage coal combustion 
wastes generated by steam electric power generators, i.e., electric 
utilities and independent power producers. This action results from 
EPA's regulatory determination for fossil fuel combustion wastes (see 
65 FR 32214, May 22, 2000), which concluded that waste management 
regulations under RCRA are appropriate for certain coal combustion 
wastes. The utility industry has made significant improvement in its 
waste management practices over recent years, and most state regulatory 
programs are similarly improving. However, public comment and other 
analyses have convinced the Agency that coal combustion wastes could 
pose significant risks to human health and the environment if they are 
not properly managed. There is sufficient evidence that adequate 
controls may not be in place. For example, 62 percent of existing 
utility impoundments do not have groundwater monitoring; thus, their 
impact on ground and surface waters cannot be evaluated in light of 
numerous damage cases identified by the Agency that involve management 
of these wastes. The intended benefits of this action will be to 
prevent contamination or damage to ground waters and surface waters, 
thereby avoiding risk to human health and the environment, including 
ecological risks. The Agency is currently analyzing the human health 
and ecological risks, costs, and economic impact of this action as it 
develops the proposed regulation. The Agency has considered 
alternatives to this action, including regulating these wastes as 
hazardous wastes under subtitle C of RCRA, but has rejected this 
approach as discussed in the regulatory determination (see 65 FR 32214, 
May 22, 2000). EPA has also considered issuing guidance instead of 
regulations to industry and state and local governments to focus on 
these remaining waste management issues but concluded that there will 
probably continue to be some gaps in practices and controls and is 
concerned at the possibility that these will go undressed. The Agency 
also believes the timeframe for improvement of current practices is 
likely to be longer in the absence of federal regulation.


Statement of Need:


Public comment and other analyses have convinced the Agency that coal 
combustion wastes could pose significant risks to human health and the 
environment if they are not properly managed. There is sufficient 
evidence that adequate controls may not be in place, including for 
ground water monitoring, lining of waste management units, and 
mismanagement of the wastes in sand and gravel pits and similar 
geologies. A significant number of environmental damage cases indicate 
that past management practices were insufficient. The intended benefits 
of this regulatory action will be to prevent contamination or damage to 
ground waters and surface waters, and to prevent ecological risks.


Summary of Legal Basis:


The rules that are being developed pursuant to RCRA subtitle D are not 
mandated by statute or court order. Rather, the Agency concluded from 
its finding in the required RCRA section 3001 (b) determination that, 
while RCRA subtitle C regulations for hazardous wastes are not 
warranted, RCRA nonhazardous waste regulations are necessary. The 
nonhazardous waste regulations will address gaps in existing Federal 
and State requirements for the management of these wastes in order to 
protect human health and the environment.


Alternatives:


The Agency has considered regulating these wastes as hazardous wastes 
under subtitle C of RCRA or a nonhazardous wastes under subtitle D of 
RCRA. The Agency also has considered issuing guidance instead of 
regulations to industry and state and local government to focus on the 
key waste management issues. However, the Agency concluded that some 
gaps in waste management practices would likely continue and is 
concerned that these gaps would continue to go unaddressed. The Agency 
concluded that non-hazardous waste regulations under subtitle D of RCRA 
are most appropriate.


Anticipated Cost and Benefits:


The costing, economics, and benefits analyses are under study pending 
results of the risk assessment. Costs will include direct costs to the 
generators of coal combustion wastes for management according to the 
regulation. Benefits will include damage avoidance to ground water and 
surface water resources, including sources of drinking water that could 
affect human health. No additional information is available at this 
time.


Risks:


The Agency has a comprehensive risk analysis underway to determine the 
cross-media impacts of managing these wastes, with a focus on impacts 
to ground waters and surface waters and their human health 
implications. The risk analysis will also identify ecological impacts 
of waste management. While the risk analysis is nearing completion, no 
quantitative measures of risk are available yet, and, thus, no 
information of risk magnitude or risk reduction efforts is available at 
this time.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           08/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 Undetermined


Additional Information:


SAN 4470. This rule may also impact Federal, State, local or tribal 
governments that own coal-burning commercial electric power generating 
facilities.


Sectors Affected:


221112 Fossil Fuel Electric Power Generation


Agency Contact:
Dennis Ruddy
Environmental Protection Agency
Solid Waste and Emergency Response
5306W
Washington, DC 20460
Phone: 703-308-8430
Fax: 703-308-8686
Email: [email protected]
RIN: 2050-AE81
_______________________________________________________________________
EPA
111. INCREASE METALS RECLAMATION FROM F006 WASTE STREAMS
Priority:


Other Significant


Unfunded Mandates:


Undetermined

[[Page 72569]]

Legal Authority:


Not Yet Determined


CFR Citation:


40 CFR 261


Legal Deadline:


None


Abstract:


Many metal finishers and other industrial sectors generate an 
electroplating sludge as part of their production process that is 
amenable to recycling, i.e., the sludge contains economically 
recoverable amounts of metals such as copper, nickel, zinc, etc. 
Currently, these sludges (F006) are listed hazardous wastes subject to 
RCRA regulations. Many generators continue to send these sludges for 
treatment and disposal when they could be recycled. Similarly, 
generators currently sending their sludges for recycling receive no 
economic benefit for this practice. Since the mid-1990's, EPA has been 
working with industry and the States to create incentives for safe 
recycling and has promulgated rules to foster this practice. However, 
EPA is interested in exploring whether further regulatory changes are 
warranted.


EPA is currently evaluating several options that would provide 
regulatory relief to generators and handlers of F006. All options would 
reduce regulatory costs to generators and handlers relative to the 
current RCRA subtitle C regulatory program.


Statement of Need:


F006 represents one of the largest hazardous waste streams amenable to 
recycling. Currently, there is no differentiation in regulatory 
requirements the land disposal and recycling of F006 electroplating 
sludges. This effort seeks to evaluate different regulatory options 
that would eliminate existing disincentives to the safe recycling of 
F006 with the ultimate objective of possibly proposing changes to the 
existing regulatory framework. Potential benefits to be achieved 
include increasing the economic competitiveness of small businesses, 
increasing the waste minimization and recycling of F006, increased 
natural resource conservation by reducing emissions from landfills and 
surface waters.


Summary of Legal Basis:


RCRA sections 2002, 3001-3004, 42 U.S.C. 6912, 6921 to 6924. No aspect 
of this action is required by statutory or court order.


Alternatives:


Regulatory options being examined would affect generators and possibly 
other handlers of F006, i.e., consolidators, commercial hazardous waste 
recyclers and mineral processing facilities. EPA is also considering 
various options for the minimum amount of recoverable metals contained 
in F006 electroplating sludges.


Anticipated Cost and Benefits:


This rule is designed to provide regulatory relief to generators and 
possibly other handlers of F006. Potential benefits to be achieved 
include increasing the economic competitiveness of small businesses, 
increasing the waste minimization and recycling of F006 and increasing 
natural resource conservation by reducing emissions from landfills and 
surface waters.


Risks:


Options being evaluated would ensure that the risks posed from 
recycling F006 would not increase. These risks include storage and 
management of the materials throughout the recycling process, as well 
as any nonrecyclable constituents included in the F006.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           08/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Additional Information:


SAN 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
_______________________________________________________________________
EPA
112. STANDARDS AND PRACTICES FOR CONDUCTING ``ALL APPROPRIATE INQUIRY''
Priority:


Other Significant


Legal Authority:


42 USC 9601 et seq


CFR Citation:


40 CFR 312


Legal Deadline:


Final, Statutory, January 11, 2004, Final.


Abstract:


The Small Business Liability Relief and Brownfields Revitalization Act 
(the Brownfields Law) amended a number of provisions in CERCLA 
including section 101(35)(B) and includes, among other things, new 
provisions regarding limitations on CERCLA liability for certain 
landowners. As part of these provisions, the Brownfields Law addresses 
the need for bona fide prospective purchasers, contiguous property 
owners, and innocent landowners to conduct ``all appropriate inquiry'' 
into prior ownership and use of the property at the time the party 
acquires the property.


In the Brownfields Law, Congress directed EPA to promulgate regulations 
establishing standards and practices for conducting ``all appropriate 
inquiry.'' Section 101 (35)(B)(iii) of the law includes criteria that 
EPA is required to address in setting these standards and practices. 
This regulation will establish the Federal standards for conducting 
``all appropriate inquiry,'' pursuant to the Act. Recipients of

[[Page 72570]]

Brownfields Assessment Grants will be regulated by the final action. 
Purchasers of contaminated properties who wish to assert certain 
limitations on CERCLA liability may choose to follow the promulgated 
procedures and standards.


EPA is developing the Federal standard for all appropriate inquiry 
under a negotiated rulemaking process. EPA established a FACA committee 
charged with negotiating a Federal standard in accordance with the 
statutory criteria.


Statement of Need:


The need for this action is the congressional mandate in the Small 
Business Liability Relief and Brownfields Revitalization Act. Section 
101(35)(B)(ii) of the law, Congress directs the EPA Administrator to 
establish (by regulation) standards and practices for the purpose of 
satisfying the requirement to carry out all appropriate inquiries. 
Congressional intent or ``need'' is that purchasers of potentially 
contaminated property must conduct an inquiry or investigation into the 
environmental conditions of a property prior to purchasing the property 
to ensure an understanding of the extent of prior and ongoing 
environment conditions to establish liability.


Summary of Legal Basis:


In Section 101(35)(B)(ii) of the Small Business Liability Relief and 
Brownfields Revitalization Act Congress directs the EPA Administrator 
to establish (by regulation) standards and practices for the purpose of 
satisfying the requirement to carry out all appropriate inquiries.


Alternatives:


EPA may consider alternative standards for specific portions of the 
regulatory requirements, if viable and suitable alternatives are 
identified by the FACA committee chartered to negotiate the 
rulemakings. No such alternatives have been identified to date.


Anticipated Cost and Benefits:


Costs associated with the new Federal standard may include incremental 
costs, associated with using the new Federal standard, that are over 
and above the costs associated with the privately developed standards 
currently employed in conducting all appropriate inquiry for the 
purposes of real estate transaction. This rulemaking will not impose 
new mandatory requirements on any entities, other than recipients of 
Federal brownfields grants provided for the purpose of assessing or 
characterizing brownfields sites. Other than these grant recipients, 
the standards will be applicable to purchasers of contaminated 
properties who wish to assert certain limitations on CERCLA liability. 
The benefits of the regulation may include providing purchasers of 
contaminated property with clarity regarding the procedures and 
standards for the conduct of ``all appropriate inquiry'' required to 
assert certain limitations on CERCLA liability.


Risks:


This regulatory action will not directly address risks to human health 
or the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           05/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN 4739. State, local and Tribal governments affected if they are 
grant recipients.


Agency Contact:
Patricia Overmeyer
Environmental Protection Agency
Solid Waste and Emergency Response
5105T
Washington, DC 20460
Phone: 202-566-2774
Fax: 202-566-2757
Email: [email protected]

Helen Keplinger
Environmental Protection Agency
Solid Waste and Emergency Response
2272A
Washington, DC 20460
Phone: 202-564-4221
Fax: 202 229-3954
Email: [email protected]
RIN: 2050-AF04
_______________________________________________________________________
EPA
113. [bull] REGULATORY AMENDMENTS TO THE F019 HAZARDOUS WASTE LISTING 
TO EXCLUDE THE WASTEWATER TREATMENT SLUDGES FROM THE CHEMICAL 
CONVERSION COATING PROCESS (ZINC PHOSPHATING) OF AUTOMOBILE BODIES OF 
ALUMINUM
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 1006 et seq


CFR Citation:


40 CFR 261.31; 40 CFR 302.4


Legal Deadline:


None


Abstract:


Automobile manufacturers are adding aluminum or aluminized components 
to automobiles to reduce the weight of vehicles to increase fuel 
economy. When aluminum components are added to the automobile assembly 
process, the current federal regulations require that the wastewater 
treatment sludges generated from this conversion coating process be 
managed as a hazardous waste under the Resource Conservation and 
Recovery Act. EPA intends to reduce burden on the regulated community 
by revising the current RCRA regulations that apply to the wastewater 
treatment sludges from the chemical conversion coating (zinc 
phosphating) of aluminum.


Statement of Need:


This action when finalized will reduce the burden on the automobile 
industry from treating sludges from the process of zinc phosphating of 
aluminum as hazardous wastes. The applicable listed hazardous waste 
(F019) was listed as such because it contains cyanide and chromium. The 
sludges from the zinc phosphating of aluminum do not contain any of 
these constituents.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           08/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No

[[Page 72571]]

Government Levels Affected:


Undetermined


Additional Information:


SAN 4834.


Agency Contact:
James Michael
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8610
Fax: 703 308-0514
Email: [email protected]

Gail Cooper
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8419
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AG15
_______________________________________________________________________
EPA
114. WATERSHED RULE: TOTAL MAXIMUM DAILY LOAD (TMDL) PROGRAM REVISIONS
Priority:


Other Significant


Legal Authority:


33 USC 1313; 33 USC 1329; 33 USC 1342; 33 USC 1256


CFR Citation:


40 CFR 9; 40 CFR 122; 40 CFR 124; 40 CFR 130


Legal Deadline:


None


Abstract:


Amend regulations governing the TMDL program to ensure that it is 
effective, 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., States, 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 jurisdiction's 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, 
section 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                                                           12/00/03
Final Action                                                   10/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Tribal


Additional Information:


SAN 4623.


Agency Contact:
Christine Ruf
Environmental Protection Agency
Water
4503T
Washington, DC 20460
Phone: 202-566-1220
Fax: 202-260-2300
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

                              -----------

                            FINAL RULE STAGE

                              -----------

115. 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.


Final, Judicial, February 27, 2004.


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

[[Page 72572]]

with, but are not limited to, the drying of wood and binders. This rule 
is anticipated to apply to the manufacture of products involving wood 
and some kind of binder or bonding agent. This project may include, but 
is not limited to, facilities that manufacture hardboard, oriented 
strandboard (OSB), medium density fiberboard (MDF), particleboard, 
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. 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            68 FR 1276                                     01/09/03
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


SAN 3820.


Sectors Affected:


32121 Veneer, Plywood, and Engineered Wood Product Manufacturing


Agency Contact:
Mary Kissell
Environmental Protection Agency
Air and Radiation
C439-03
Research Triangle Park, NC 27711
Phone: 919 541-4516
Fax: 919 541-0246
Email: [email protected]

Kent 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
116. 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 112; PL 101-549


CFR Citation:


40 CFR 63


Legal Deadline:


Final, Statutory, November 15, 2000.


Final, Judicial, February 27, 2004.


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 reciprocating internal combustion engine 
(RICE) MACT was published in the Federal Register on December 19, 2002. 
A public hearing was held on January 21, 2003 and the public comment 
period closed on February 18, 2003. Comments and data received during 
the comment period are being evaluated. The anticipated date of the 
final RICE rule being signed by the Administrator is February 27, 2004.


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            67 FR 77830                                    12/19/02
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Local, State


Additional Information:


SAN 3656.

[[Page 72573]]

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 Wayland
Environmental Protection Agency
Air and Radiation
C-439-01
Research Triangle Park, NC 27711
Phone: 919 541-1045
Fax: 919 541-5450
Email: [email protected]
RIN: 2060-AG63
_______________________________________________________________________
EPA
117. 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.


Final, Judicial, February 27, 2004.


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:


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:


Implementation of the rulemaking would reduce nationwide emissions of 
air toxics by 58,000 tons per year in the fifth 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            68 FR 1660                                     01/13/03
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Local


Additional Information:


SAN 3837.


Agency Contact:
James 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 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
118. NESHAP: SURFACE COATING OF AUTOMOBILES AND LIGHT-DUTY TRUCKS
Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 7412


CFR Citation:


40 CFR 63


Legal Deadline:


Final, Judicial, February 27, 2004.


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 categorie in 1980. The 
standards for the NESHAP are to be technology-based are are to require 
the maximum achievable control technology as described in section 112 
of the CAA.


Statement of Need:


Surface coating of automobiles and 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 72574]]

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:


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            67 FR 78612                                    12/24/02
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State


Additional Information:


SAN 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
C539-03
Research Triangle Park, NC 27711
Phone: 919-541-5342
Fax: 919 541-5689
Email: [email protected]
RIN: 2060-AG99
_______________________________________________________________________
EPA
119. IMPLEMENTATION RULE FOR 8-HOUR OZONE NAAQS
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 7408; 42 USC 7410; 42 USC 7501 to 7511f; 42 USC 7601(a)(1)


CFR Citation:


40 CFR 51; 40 CFR 50; 40 CFR 81


Legal Deadline:


None


Abstract:


This rule would provide specific requirements for State and local air 
pollution control agencies and tribes to prepare State implementation 
plans (SIPs) and Tribal Implementation Plans (TIPs) under the 8-hour 
national ambient air quality standard (NAAQS) for ozone, published by 
EPA on July 18, 1997. The Clean Air Act (CAA) 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 CAA related to implementation 
of a revised NAAQS, 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 CAA and the Supreme Court's ruling. This rule would provide 
detailed provisions to address the CAA requirements for SIPs and TIPs 
and would thus affect States and Tribes. 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 CAA. Tribal lands that are not 
attaining the 8-hour ozone standard may be affected, and could 
voluntarily submit a 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 alternatives facing the Agency is 
whether the 8-hour O3 NAAQS should be implemented under the less 
prescriptive part of the Clean Air Act (title I, part D, subpart 1) or 
the more prescriptive part of the Act (subpart 2). Another major set of 
alternatives concern the kind of transition EPA should make from 
implementation of the current 1-hour ozone standard to the new 8-hour 
ozone standard.


Anticipated Cost and Benefits:


EPA prepared a regulatory impact analysis for the final ozone NAAQS, 
and has prepared a cost analysis for the proposed implementation rule. 
The

[[Page 72575]]

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            68 FR 32802                                    06/02/03
Final Action                                                   12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State, Tribal


Additional Information:


SAN 4625.


Agency Contact:
John Silvas
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
Email: [email protected]
RIN: 2060-AJ99
_______________________________________________________________________
EPA
120. 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 May 23, 2003, EPA proposed new emission controls for nonroad diesel 
engines, which are generally used in industrial, mining, and 
agricultural applications. The control strategies proposed focused 
around the use of advanced exhaust aftertreatment technologies for the 
first time in these applications. This technology reduces emissions of 
NOx, NMHC, and PM of over 90 percent. The standards would phase-in 
between 2008 and 2014, with different implementation schedules 
applicable to each of the five engine horsepower categories. Less 
stringent standards would apply to the smallest horsepower category. 
Coupled with these proposed engine standards is a two-step reduction in 
fuel sulfur levels, going from uncontrolled levels to 500 ppm in 2007 
and then to 15 ppm in 2010. All nonroad diesel fuel, including that 
used in locomotive and marine applications, is covered in the first 
step while locomotive and marine fuel is not involved in the second 
step. This overall program builds on the successful 2007 highway diesel 
program the Agency completed in 2000.


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 sections 213 and 217.


Alternatives:


Eleven separate alternatives were analyzed as part of the proposal. 
Estimated cost impacts and benefits were estimated where possible. The 
alternatives looked at varying implementation dates or control 
strategies of both the fuel and engine standards. In addition, 
controlling sulfur levels to 15 ppm in 2010 for locomotive and marine 
diesel fuel was also analyzed.


Anticipated Cost and Benefits:


The total cost (engine and fuel standards) estimate of the proposed 
requirements was approximately $1.5 billion per year. In 2030, when the 
full effects of the rule would be in place, the quantifiable benefits 
would be approximately $81 billion per year. This estimate includes the 
impacts of reducing 9,600 cases of premature mortality, almost a 
million work lost days, and improvements to recreational visibility.


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            68 FR 28327                                    05/23/03
Final Action                                                   04/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, Local, State


Additional Information:


SAN 4675.

[[Page 72576]]

Agency Contact:
Cleophas Jackson
Environmental Protection Agency
Air and Radiation
ASD
Ann Arbor, MI 48105
Phone: 734-214-4824
Fax: 734 214-4816
Email: [email protected]

William Charmley
Environmental Protection Agency
Air and Radiation
ASD
Washington, DC 20460
Phone: 734-214-4466
Fax: 734 214-4050
Email: [email protected]
RIN: 2060-AK27
_______________________________________________________________________
EPA
121. HAZARDOUS WASTE MANIFEST REGULATION
Priority:


Other Significant


Legal Authority:


42 USC 6922 RCRA 3002; 42 USC 6923 RCRA 3003; 42 USC 6924 RCRA 3004; 42 
USC 6926 RCRA 3006; PL 105-277; Government Paperwork Elimination Act 17


CFR Citation:


40 CFR 260; 40 CFR 262; 40 CFR 263; 40 CFR 264; 40 CFR 265; 40 CFR 271


Legal Deadline:


None


Abstract:


The Uniform Hazardous Waste Manifest (Form 8700-22) is a multi-copy 
form used to identify the quantity, composition, origin, routing, and 
destination of hazardous waste during its transportation. Waste 
handlers (e.g., generators and transporters) are required to use the 
manifest, and States may not require a different manifest in its place. 
However, the manifest has State blocks which allow States, at their 
option, to require the entry of additional specific information to 
serve their State's regulatory needs. Under the current regulations 
more than 20 States print the manifest form in accordance with the 
format specified in federal regulations. However, the variability among 
State manifest programs associated with state optional blocks, 
different copy distribution schemes, and the manifest hierarchical 
acquisition scheme has drawn complaints from the regulated community. 
Variability among States' Manifest programs and the manifest system's 
current reliance on paper result in significant paperwork and cost 
burden to waste handlers and States who choose to collect manifest 
information. The Agency intends to standardize further the manifest 
form elements, and to specify one format for the manifests that may be 
used in all states. In addition, the Agency intends to announce 
standard requirements for tracking rejected wastes, container residues, 
and international shipments of hazardous wastes. Finally, the Agency 
intends to pursue an optional approach that would use information 
technologies to conduct the manifest process electronically, thereby 
reducing paperwork burden, and improving the speed and accuracy of 
preparing, transmitting, and recordkeeping the manifest form. However, 
the Agency will bifurcate the manifest rule so that the form revisions 
may be expedited, while additional analysis on the e-manifest 
continues.


Statement of Need:


Since the adoption of the Uniform Manifest by EPA and the Department of 
Transportation (DOT) in 1984, the regulated community and authorized 
states have pressed EPA to adopt changes that would simplify and 
further reduce the variability among the hazardous waste manifest forms 
required and distributed by the states. In addition, the recent focus 
on electronic government has highlighted the potential advantages of an 
electronic manifest system in terms of reduced paperwork burdens and 
more timely waste tracking. This action responds to these needs with a 
truly universal set of manifest data elements and a manifest format 
that will be identical in all states, as well as standards that will 
allow the manifest data to be completed, signed, transmitted, and 
recorded electronically.


Summary of Legal Basis:


EPA's regulations implementing the manifest are based on section 
3002(a)(5) of the RCRA statute, which requires that EPA include in its 
hazardous waste generator regulations requirements addressing the ``use 
of a manifest system and ony other reasonable means necessary'' to 
assure that all such hazardous waste is designated for and designated 
for and arrives at treatment, storage, or disposal facilities that have 
been permitted under RCRA subtitle C requirements. Secion 3003(a)(3) of 
the Act requires transporters of hazardous waste to comply with the 
manifest system, while section 3004(a)(2) requires compliance with the 
manifest system by treatment, storage, and disposal facilities. 
Moreover, according to section 1004(12) of the Act, the manifest is 
defined as the ``form used for identifying the quantity, composition, 
and the origin, routing, and destination of hazardous waste during its 
transportation from the point of generation to the point of disposal, 
treatment, or storage.'' The manifest also serves as teh ``shipping 
paper'' meeting DOT requirements for the transportation of hazardous 
materials under the Federal Hazardous Materials laws and regulations.


EPA's current manifest regulations require generators to obtain 
manifest froms from the authorized States. The generator must complete 
the paper form by identifying the type and quantity of hazardous waste 
in off-site shipments, as well as the identities of the transporters 
and waste receiving facilities that will manage the waste. The 
regulations require waste handlers to sign the manifest form by hand 
when they receive a waste shipment, and to retain copies of the signed 
manifests that document the chain of custody of a shipment, and any 
discrepancies.


EPA and DOT have authority to eliminate variability among state 
manifests, since DOT's hazardous materials laws generally call for 
uniformity in the use of hazardous materials shipping papers such as 
the manifest, and EPA must regulate transportation consistently with 
DOT. EPA and DOT consented in 1984 to the inclusion of several 
``optional'' data fields, but our experience with the manifest system 
has demonstrated that the inclusion of optional fields introduces 
excessive variability and burden for waste handlers. EPA also has 
authority to automate the waste tracking functions of the manifest, 
since the Act states that EPA can employ any reasonable means necessary 
to track waste shipments under a manifest system. There is nothing in 
the statute that precludes EPA from establishing standards allowing 
electronic manifesting of shipments, as well as use of the traditional 
paper forms.


Alternatives:


The form revisions part of the rulemaking examines alternatives to the 
current system that allows authorized states to print and distribute 
slightly varying manifest forms (typically for a fee) to waste handlers 
generating or shipping waste in a particular state.

[[Page 72577]]

This rule would establish a precise Federal specification for the 
manifest that would preclude variability in manifest forms, wherever 
they are used. This option was proposed in May 2001, and was supported 
by the great preponderance of commenters who submitted written comments 
to the docket.


The rule also examines alternative electronic formats for completing 
electronic manifests, and alternative methods for signing manifests 
electronically. Moreover, EPA has been examining in response to 
comments whether electronic manifest systems should be developed in a 
decentralized fashion by private companies in adherence with standards 
announced by EPA (the proposed approach), or, developed and hosted 
centrally in a national system. We expect that additional stakeholder 
outreach will be necessary to determine the appropriate design and 
functionality of the e-manifest approach for the final rule. Therefore, 
the e-manifest part of the rulemaking has been separated from the form 
revisions part of the rule, so that final action on the form revisions 
will not be delayed by future outreach and analysis conducted in 
connection with the e-manifest.


Anticipated Cost and Benefits:


The baseline manifest system results in annual paperwork burdens of 4.6 
million hours and annual costs of about $193 million. In developing the 
May 2001, proposed rule, EPA estimated that the proposed revisions to 
the hazardous waste manifest system (form changes and electronic 
manifest) would reduce the paperwork burdens impoosed by the manifest 
by 765,000 to 1.24 million hours annually, and would reduce annual 
costs by $24-$37 million. The rule should also eliminate much of the 
complexity that arises from having to obtain and comply with states' 
slightly varying manifest forms, and the burden and complexity of 
having to supply information to satisfy the current so-called 
``optional'' state fields. The ability to complete and transmit 
manifest data electronically should improve the accuracy of manifest 
data, and the timeliness and effectiveness of waste shipment tracking.


Risks:


This rule addresses only administrative requirements for tracking waste 
shipments. The rule does not address risks posed by particular 
substances or waste management activities, and no risk assessments have 
been prepared to support this action.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            66 FR 28240                                    05/22/01
Final Action                                                   12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN 3147. Because of significant issues identified during the public 
comment period on the electronic manifest part of the rule, this part 
of the rule has been separated from the form revisions part of the rule 
for purposes of publishing a final action. The form revisions part of 
the rule will be finalized first, while final action on the electronic 
manifest must await further stakeholder outreach and analysis.


Sectors Affected:


325 Chemical Manufacturing; 2211 Electric Power Generation, 
Transmission and Distribution; 332 Fabricated Metal Product 
Manufacturing; 2122 Metal Ore Mining; 2111 Oil and Gas Extraction; 326 
Plastics and Rubber Products Manufacturing; 331 Primary Metal 
Manufacturing; 323 Printing and Related Support Activities; 3221 Pulp, 
Paper, and Paperboard Mills; 482 Rail Transportation; 484 Truck 
Transportation; 5621 Waste Collection; 5622 Waste Treatment and 
Disposal; 483 Water Transportation


Agency Contact:
Rich Lashier
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8796
Fax: 703 308-0522
Email: [email protected]

Bryan Groce
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8750
Fax: 703 308-0522
Email: [email protected]
RIN: 2050-AE21
_______________________________________________________________________
EPA
122. MANAGEMENT OF CEMENT KILN DUST (CKD)
Priority:


Other Significant


Legal Authority:


42 USC 6912(a) RCRA 2002(a); 42 USC 6921(a) RCRA 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 (67 FR 48648) to announce the 
availability for public inspection and comment of recently acquired 
data on CKD.


The Agency is now considering an approach whereby it would finalize the 
proposed option of issuing the protective CKD management standards as 
described in the August 20, 1999 proposal as a RCRA subtitle D rule. 
The Agency would temporarily suspend its active consideration of the 
proposed listing of mismanaged CKD as a hazardous waste, and assess how 
CKD management practices and state regulatory programs evolve over the 
next three to five years. Based on this assessment, EPA will then 
proceed to either formally withdraw or promulgate the portion of the 
1999 proposal that classifies as a RCRA hazardous waste CKD that has 
been egregiously mismanaged.


EPA will be promoting pollution prevention, recycling, and safer 
disposal of CKD by considering finalization of protective management 
standards for this waste. The Agency believes that these management 
standards are a creative, affordable, and common sense approach that 
can

[[Page 72578]]

protect human health and the environment without imposing unnecessary 
regulatory burdens on the cement kiln industry. These standards provide 
a new, tailored framework that safeguards ground water and limits risk 
from releases of dust to air.


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 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 effect the economy by less 
than $100 million per year. EPA also estimated that the proposed rule 
may result in a reduced risk of ).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--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 1        60 FR 7366                                     02/07/95
NPRM            64 FR 45632                                    08/20/99
Notice 2        67 FR 48648                                    07/25/02
Notice 3        67 FR 68130                                    11/08/02
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN 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
123. 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

[[Page 72579]]

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 onsite 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 
individual RCRA permit process. 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. 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 onsite 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 onsite, but asked for 
comment on whether to expand that scope to facilities that manage 
wastes generated offsite. 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 onsite 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                                                   03/00/04

[[Page 72580]]

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN 4028.


Sectors Affected:


3251 Basic Chemical Manufacturing; 332813 Electroplating, Plating, 
Polishing, Anodizing and Coloring; 32551 Paint and Coating 
Manufacturing; 32532 Pesticide and Other Agricultural Chemical 
Manufacturing; 32411 Petroleum Refineries; 325211 Plastics Material and 
Resin Manufacturing; 3252 Resin, Synthetic Rubber, and Artificial and 
Synthetic Fibers and Filaments Manufacturing


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
_______________________________________________________________________
EPA
124. OFFICE OF SOLID WASTE BURDEN REDUCTION INITIATIVE
Priority:


Other Significant


Legal Authority:


42 USC 6907; 42 USC 6912(a); 42 USC 6921 to 6927; 42 USC 6930; 42 USC 
6934; 42 USC 6935; 42 USC 6937 to 6939; 42 USC 6944; 42 USC 6949(a); 42 
USC 6974; PL 104-13


CFR Citation:


40 CFR 261.38; 40 CFR 264.16; 40 CFR 264.52; 40 CFR 264.56; 40 CFR 
264.73; 40 CFR 264.98 et seq; 40 CFR 265.16; 40 CFR 265.52; 40 CFR 
265.56; 40 CFR 265.73; 40 CFR 265.98 et seq; 40 CFR 266.103; 40 CFR 
261.4; 40 CFR 268.7; 40 CFR 268.9


Legal Deadline:


None


Abstract:


EPA plans to reduce the burden imposed by the RCRA reporting and 
recordkeeping requirements to help meet the Federal Governmentwide goal 
established by the Paperwork Reduction Act (PRA).


In June 1999, EPA published a Notice of Data Availability (NODA) in the 
Federal Register (64 FR 32859) to seek comment on a number of burden 
reduction ideas. After reviewing the 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. EPA is planning to issue a notice to seek further input on a 
number of changes we proposed. EPA will then finalize this burden 
reduction effort.


Statement of Need:


The Paperwork Reduction Act of 1995 establishes a Federal 
Governmentwide goal to reduce the paperwork and reporting burden it 
imposes. The RCRA Burden Reduction Initiative Proposed rulemaking makes 
the regulatory changes necessary to meet this goal.


Summary of Legal Basis:


This action is not required by statute or court order.


Alternatives:


Reducing recordkeeping and reporting will require changes in our 
regulations. There was no alternative to 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 for the final rule. 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
NODA            68 FR 61662                                    10/29/03
Final Action                                                   05/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN 4084. Applicable SIC codes: Chemicals and Allied Products (28), 
Primary Metal Industries (33), Fabricated Metals (34), Industrial 
Machinery and Equipment (35), Electrical Equipment (36), Transportation 
Equipment (37), Other Manufacturing, Transportation and Utilities (40-
49), Wholesale Trade (50-51), Services (70-89) and Other SIC Groups


Sectors Affected:


325 Chemical Manufacturing; 334 Computer and Electronic Product 
Manufacturing; 332 Fabricated Metal Product Manufacturing; 324 
Petroleum and Coal Products Manufacturing; 326 Plastics and Rubber 
Products Manufacturing; 331 Primary Metal Manufacturing; 323 Printing 
and Related Support Activities; 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
125. RECYCLING OF CATHODE RAY TUBES (CRTS) AND MERCURY-CONTAINING 
EQUIPMENT: CHANGES TO HAZARDOUS WASTE REGULATIONS
Priority:


Other Significant


Legal Authority:


42 USC 6912(a); 42 USC 6921 to 6925


CFR Citation:


40 CFR 261; 40 CFR 273


Legal Deadline:


None


Abstract:


This action will ultimately revise the existing Federal hazardous waste 
regulations to encourage recycling and better management of Cathode Ray

[[Page 72581]]

Tubes (CRTs) by providing a conditional exclusion from the definition 
of solid waste for CRTs being recycled. A CRT is the display component 
of a television or computer monitor. A CRT is made largely of 
specialized glasses, some of which contain lead to protect the user 
from X-rays inside the CRT. Due to the lead, when they are disposed of 
or reclaimed, some CRTs are hazardous wastes under the Federal Resource 
Conservation and Recovery Act (RCRA) regulations. This rule will also 
streamline RCRA requirements for managing mercury-containing equipment 
by adding such equipment to the universal waste rule. This rule is 
planned in response to a June 9, 1998 recommendation on CRT recycling 
from the Common Sense Initiative (CSI) Council to the Environmental 
Protection Agency (EPA), and in response to a petition from the 
Utilities Solid Waste Activities Group regarding mercury-containing 
equipment. The goal of this action is to improve management and 
encourage recycling, thereby minimizing disposal of mercury, increasing 
resource recovery, and enhancing protection of human health and the 
environment. The mercury-containing equipment rule will be published at 
a later date.


Statement of Need:


This rule is needed to respond to recommendations of the Electronics 
Subcommittee of the CSI Council regarding CRT recycling, and also to 
respond to a petition from the Utilities Solid Waste Activities Group 
regarding management of mercury-containing equipment. It is also needed 
to streamline RCRA requirements for these materials to encourage better 
management and recycling.


Summary of Legal Basis:


This action is not required by statute or court order.


Alternatives:


EPA solicited comments on alternative management requirements, 
including notification and tracking, accumulation requirements, 
requirements for CRT glass processors, export requirements, and 
disposal requirements.


Anticipated Cost and Benefits:


EPA estimates that, if finalized, this action would result in annual 
savings of up to $3 million to reduce administrative, transportation, 
and management costs compared to current regulations.


Risks:


The risks are undetermined.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 40507                                    06/12/02
Final Action                                                   05/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN 4092.


Sectors Affected:


334411 Electron Tube Manufacturing


Agency Contact:
Marilyn Goode
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703-308-8800
Fax: 703 308-0512
Email: [email protected]
RIN: 2050-AE52
_______________________________________________________________________
EPA
126. 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 300 g-1``SDWA 1412 (b)(8)''


CFR Citation:


40 CFR 141; 40 CFR 142


Legal Deadline:


Other, Statutory, Other.


Abstract:


EPA has proposed a targeted risk-based regulatory strategy for all 
public water systems served by groundwater. 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 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 groundwater 
systems as necessary and ``. . . (as part of the regulations) 
promulgate criteria. . . to determine whether disinfection shall be 
required as a treatment technique for any public water system served by 
groundwater.''


Alternatives:


EPA considered four regulatory alternatives in the development of the 
GWR proposal; the proposed regulatory alternative (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

[[Page 72582]]

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 by-products. 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 
groundwater 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                                                   04/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


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


Additional Information:


SAN 2340. Statutory deadline for final rule: After August 6, 1999, but 
not later than 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
127. NATIONAL PRIMARY DRINKING WATER REGULATIONS: LONG TERM 2 ENHANCED 
SURFACE WATER TREATMENT RULE
Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


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 has analyzed 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, has provided a substantially more comprehensive and complete 
picture of the occurrence of waterborne pathogens than was available 
previously. EPA has also used 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

[[Page 72583]]

30, 1999 EPA established a committee of stakeholders under the Federal 
Advisory Committee Act (FACA) to assist in the development of these 
rules; 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 healthy 
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, as proposed will have an annual cost 
of $73 to $111 million per year. The majority of people (approximately 
67 percent) are served by public water systems that use a surface water 
or ground water under the direct influence of surface water. Thus, a 
large number of people will benefit from the LT2ESWTR. EPA estimates 
that the proposed LT2ESWTR would prevent up to 1,020,000 cases of 
cryptosporidiosis annually with an economic benefit of up to $1.4 
billion. 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            68 FR 47639                                    08/11/03
Final Action                                                   07/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


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


Additional Information:


SAN 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
4607M
4607
Washington, DC 20460
Phone: 202-564-5262
Fax: 202 564-3767
Email: [email protected]
RIN: 2040-AD37
_______________________________________________________________________
EPA
128. NATIONAL PRIMARY DRINKING WATER REGULATIONS: STAGE 2 DISINFECTION 
BYPRODUCTS RULE
Priority:


Economically Significant. Major under 5 USC 801.

[[Page 72584]]

Unfunded Mandates:


This action may affect State, local or tribal governments and the 
private sector.


Legal Authority:


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 analyzed 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, provide a 
substantially more comprehensive and complete picture of the occurrence 
of DBPs and microbiological pathogens than was available previously. 
EPA also used 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; 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.


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 $59-65 million. 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            68 FR 49548                                    08/18/03
Final Action                                                   07/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


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


Additional Information:


SAN 4342.


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Tom Grubbs
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 564-5262
Fax: 202 564-3767
Email: [email protected]

Stig Regl
Environmental Protection Agency
Water
4607M
4607
Washington, DC 20460
Phone: 202-564-5270
Fax: 202 564-3767
Email: [email protected]
RIN: 2040-AD38

[[Page 72585]]

_______________________________________________________________________
EPA
129. EFFLUENT GUIDELINES AND STANDARDS FOR THE CONSTRUCTION AND 
DEVELOPMENT INDUSTRY
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 301; 33 USC 1314 CWA 304; 33 USC 1316 CWA 306; 33 USC 
1318 CWA 308; 33 USC 1342 CWA 402; 33 USC 1361 CWA 501


CFR Citation:


40 CFR 450; 40 CFR 122


Legal Deadline:


NPRM, Judicial, May 15, 2002.


Final, Judicial, March 31, 2004.


Abstract:


The effluent guidelines would apply to some construction activities 
associated with new development, as well as to those associated with 
redevelopment activities. The regulations would address storm water 
runoff from construction sites during the active phase of construction. 
Construction activity is a major source of sediment and other 
pollutants discharged to the nation's waters. Industries potentially 
affected by this rulemaking include land developers, home builders, 
builders of commercial and industrial property, and other private and 
public sector construction site owners and operators. EPA proposed 
design criteria for erosion and sediment controls. These requirements 
would be implemented in NPDES storm water permits issued to 
construction site owners and operators.


Statement of Need:


The 2000 National Water Quality Inventory Report to Congress indicates 
that 39 percent of assessed rivers and streams are impaired for one or 
more uses. Siltation is the leading pollutant causing water quality 
problems in 31 percent of these impaired rivers and streams. Storm 
water discharges from construction and development projects contain 
sediment that contribute to water quality impairment. There is 
currently wide variation in existing requirements across the nation 
designed to control construction site storm water discharges. The 
effluent guidelines would provide a national set of criteria for the 
selection, design, installation, and maintenance of erosion and 
sediment controls to control storm water discharges from construction 
sites. These requirements are expected to significantly reduce the 
discharge of sediment from construction sites and improve water 
quality.


Summary of Legal Basis:


The Clean Water Act authorizes EPA to establish effluent limitations 
guidelines and standards to limit the pollutants discharged from point 
sources. In addition, EPA is bound by a provision in a consent decree 
entered in settlement of Natural Resources Defense Council et al. v. 
Reilly (D.D.C. No.89-2980) to propose regulations for this industry by 
May 15, 2002, and to take final action by March 31, 2004.


Alternatives:


The Clean Water Act directs EPA to establish a technology basis for the 
effluent guidelines. Limitations are based on the performance of 
specific technology levels, such as the best available technology 
economically achievable. EPA is considering a range of pollution 
control technologies and is also considering construction site size 
exemptions to reduce the impact on small dischargers.


Anticipated Cost and Benefits:


The annualized costs of the proposed effluent guidelines are estimated 
to range from $130 million to $505 million and the annualized monetized 
benefits are expected to range from $10 million to $22 million. The 
costs include capital costs to install erosion and sediment controls as 
well as operation and maintenance costs. The benefits from the effluent 
guidelines are expected to occur by reducing discharges of sediment to 
water bodies. In addition to the monetized benefits, EPA expects there 
to be significant nonquantified and nonmonetized benefits to aquatic 
habitat and aquatic resources.


Risks:


The effluent guidelines are expected to result in a reduction of the 
discharge of pollutants to surface waters, primarily sediment. Sediment 
discharges to surface waters present a significant risk to aquatic 
resources.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            67 FR 42644                                    06/24/02
Final Action                                                   03/00/04
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN 4280.


For more information on the construction and development rule visit Web 
site.


Sectors Affected:


233 Building, Developing and General Contracting; 234 Heavy 
Construction


Agency Contact:
Eric Strassler
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202-566-1026
Fax: 202 566-1053
Email: [email protected]

Jesse Pritts
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202-566-1038
Fax: 202 566-1053
Email: [email protected]
RIN: 2040-AD42
_______________________________________________________________________
EPA
130. 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 301; 33 USC 1316 CWA 306; 33 USC 1326 CWA 316; 33 USC 
1361 CWA 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.

[[Page 72586]]

Final, Judicial, February 16, 2004.


Abstract:


This rulemaking affects, at a minimum, existing electricity generating 
facilities that employ cooling water intake structures and whose intake 
flow levels exceed a minimum threshold to be determined by EPA during 
the rulemaking. Section 316(b) of the Clean Water Act provides that any 
standard established pursuant to sections 301 or 306 of the Clean Water 
Act and applicable to a point source shall require that the location, 
design, construction, and capacity of cooling water intake structures 
reflect the best technology available for minimizing adverse 
environmental impact. A primary purpose of the rulemaking is to 
minimize any adverse environmental impact that may be associated with 
the impingement and entrainment of fish and other aquatic organisms by 
cooling water intake structures. Impingement refers to trapping fish 
and other aquatic life on intake screens or similar devices where they 
may be injured or killed. Entrainment occurs when smaller aquatic 
organisms, eggs, and larvae are drawn into a cooling system, and then 
pumped back out, often with significant injury or mortality due to 
heat, physical stress, or exposure to chemicals.


Statement of Need:


In the absence of national regulations, permit directors have 
implemented cooling water intake limitations incompletely and 
inconsistently and, in some cases, permit issuance or reissuance has 
been significantly delayed. This regulation may have substantial 
ecological benefits. By court order, EPA must propose and take final 
action on this regulation.


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:


Based on a notice of data availability, costs are estimated to be $265 
million annually. The benefits of the proposed rule include 
quantifiable increases in commercial and recreational fisheries and 
difficult-to-quantify nonuse benefits. Costs and benefits are 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            67 FR 17122                                    04/09/02
NODA            68 FR 13522                                    03/19/03
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN 4474. Split from RIN 2040-AC34.


Sectors Affected:


2211 Electric Power Generation, Transmission and Distribution


Agency Contact:
Debbi Hart
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202-566-6379
Fax: 202 566-1053
Email: [email protected]

Martha Segall
Environmental Protection Agency
Water
4303T
Washington, DC 20460
Phone: 202-566-1041
Fax: 202 566-1053
Email: [email protected]
RIN: 2040-AD62
BILLING CODE 6560-50-S

[[Page 72587]]

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, 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.
 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 Age Discrimination in Employment 
Act (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. The Commission does 
not believe that the proposed exemption will have a significant impact 
on small business entities under the Regulatory Flexibility Act because 
it imposes no economic or reporting burdens on such firms.
 Consistent with section 4(c) of Executive Order 12866, this statement 
was reviewed and approved by the Chair of the Agency. The statement has 
not been reviewed or approved by the other members of the Commission.
_______________________________________________________________________
EEOC

                              -----------

                            FINAL RULE STAGE

                              -----------

131. 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 U.S.C. 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            68 FR 41542                                    07/14/03
NPRM Comment Period End                                        09/12/03
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State

[[Page 72588]]

Agency Contact:
Dianna B. Johnston
Assistant Legal Counsel, Office of Legal Counsel
Equal Employment Opportunity Commission
1801 L Street NW
Washington, DC 20507
Phone: 202 663-4638
TDD Phone: 202 663-7026
Fax: 202 663-4639
Email: [email protected]
RIN: 3046-AA72
BILLING CODE 6570-01-S

[[Page 72589]]

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 2004 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 6820-34-S

[[Page 72590]]

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 2003 Strategic Plan, is to 
understand and protect our home planet, to explore the universe and 
search for life, and to inspire the generation of explorers as only 
NASA can.
 Our mission is driven by science, exploration, and discovery, and it 
will be carried out with a firm commitment to fiscal responsibility. We 
will study climate change and the natural and human-induced hazards to 
Earth's ecosystem. We will help to counter the threat of international 
terrorism by developing technologies that can improve the security and 
safety of our air transportation system. We will lead the world into a 
new understanding of our planet, our solar system, and the universe 
around us, and in so doing, we will begin to understand whether life 
may have developed elsewhere in the cosmos.
 The following are narrative descriptions of the most important 
regulations being planned for publication in the Federal Register 
during fiscal year (FY) 2004.
 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 2004, 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.
 Re-issuance of the NFS is planned for FY 2004. As part of this re-
issuance, the NFS is being reviewed to identify and remove from the 
Code of Federal Regulations (CFR) those portions of the NFS containing 
information that consists of internal Agency administrative procedures 
and guidance. The NFS document will continue to contain both 
information requiring codification in the CFR and internal Agency 
guidance in a single document that is available on the Internet.
 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 72591]]

NATIONAL ARCHIVES AND RECORDS ADMINISTRATION (NARA)
Statement of Regulatory Priorities
Overview
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 the 
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 2004. The first, 
included in The Regulatory Plan, is to complete the review of our 
records management regulations in 36 CFR ch. XII, subchapter B, and 
begin revising and updating the regulations. We anticipate that we will 
be proposing a new organizational framework for the records management 
regulations to make them easier to use. This regulatory activity is 
part of a major NARA initiative to review and redesign our records 
management program that started in 2000.
The second priority is to complete the necessary actions relating to 
the review of our records center facility standards regulation in 36 
CFR part 1228, subpart K. This regulation affects small businesses and 
is discussed in greater detail in the following section.
Our third priority regulatory action is completing the revision of our 
research room regulations and restrictions on access regulations in 36 
CFR parts 1254 and 1256, including writing them in plain language. 
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.
Regulations of Particular Concern to Small Businesses
NARA's regulation specifying facility standards for records storage 
facilities that house Federal records (RIN 3095-AA81) has been 
identified as being of particular concern to small businesses. The 
regulation went into effect in 2000 and was among the public reform 
nominations in the Office of Management and Budget's (OMB) 2002 Report 
to Congress on the Costs and Benefits of Regulations. OMB referred this 
regulation to NARA for evaluation. Because of the stated concerns that 
the regulation places a burden on small businesses, we are reviewing 
the regulation to identify possible modifications to the regulation 
that will still ensure protection of Federal records while reducing the 
burden on records centers that are small businesses. This review may 
result in further rulemaking activity.
_______________________________________________________________________
NARA

                              -----------

                             PRERULE STAGE

                              -----------

132. 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 1220 to 1238


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 are developing 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.

[[Page 72592]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Begin Review                                                   09/17/02
ANPRM                                                          02/00/04
ANPRM Comment Period End                                       04/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


URL For More Information:
www.archives.gov/records--management/initiatives/strategic--
directions.html
URL For Public Comments:
www.regulations.gov
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 72593]]

OFFICE OF PERSONNEL MANAGEMENT (OPM)
Statement of Regulatory Priorities
 The Office of Personnel Management (OPM) is the human resources (HR) 
and personnel manager for the President and the Federal Government. The 
primary focus of OPM's regulatory efforts in the coming year will 
continue to be the modernization and improvement of HR management to 
support the President's goal of creating a Government that is citizen-
centered, results-oriented and market-based. To this end, OPM's primary 
regulatory objective is to implement improvements to HR management 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.
 The President's Management Agenda 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. OPM is the managing partner 
on this Presidential Initiative and has aggressively implemented a 
program to assist other agencies in achieving success in this area 
through aligning human resources management practices with agency 
missions and objectives. OPM will implement this initiative by way of 
regulation as necessary and appropriate during the coming year.
Department of Homeland Security
 The Homeland Security Act (HSA) authorized the creation of the 
Department of Homeland Security (DHS) through the combination of 
components of 22 other departments and agencies. In addition, the HSA 
granted the President flexibility in the management of the Department's 
human resources that are directly engaged in critical security 
functions. OPM has been working with DHS to design a personnel system 
that incorporates the HR flexibilities required to protect national 
security and to identify and address regulatory changes that will 
create an HR system that is responsive to the critical needs of the 
Department. Given the urgent mission of DHS, it is certain that this 
regulatory activity will continue to be a priority for OPM in the 
coming year.
Compensation Reform
 OPM continues to study compensation reform and to gather information 
from stakeholders following the publication of OPM Director Kay Coles 
James' white paper on Federal compensation reform: A Fresh Start for 
Federal Pay: The Case for Modernization. In addition, a proposal to 
establish a $500 million Human Capital Performance Fund (HCPF) was 
included in the President's budget for fiscal year 2004. Pending final 
legislative action, OPM will be prepared to promulgate regulations to 
implement its provisions. In addition, because compensation reform is a 
necessary element of improving the management of human capital--a 
central goal of the President's Management Agenda--OPM anticipates 
making promulgation of compensation reform regulations a priority in 
2004.
e-Government
 OPM has been designated as the managing partner on 5 of the 24 e-
Government initiatives in the President's Management Agenda. 
Specifically, OPM is the managing partner for Recruitment One Stop, e-
Clearance, e-Training, e-Payroll, and e-Enterprise HR Integration (e-
EHRI). In addition, the Office of Management and Budget (OMB) have 
asked OPM to submit a business case for a sixth e-Government 
initiative, electronic Human Resource Information Systems (e-HRIS). OMB 
has indicated that OPM would be the managing partner of this initiative 
if OMB decides to go forward with the project. These initiatives will 
require promulgation of new or modified regulations.
No FEAR Regulations
 In July, the President delegated responsibility for promulgating 
regulations pursuant to title II of the Notification and Federal 
Employee Antidiscrimination and Retaliation Act of 2002 to OPM. The 
provisions of title II relate to reimbursement of the judgment fund, 
notice and training for applicants and employees, and reporting 
requirements by agencies. Additionally, OPM will promulgate regulations 
for completing a comprehensive study on disciplinary actions and 
issuing guidance on best practices that agencies can adopt.
 OPM will continue to improve the Federal Government's human resources 
management systems in order to preserve the merit-based civil service 
system, promote fairness and diversity, and provide a workforce that 
allows the Government to achieve results for the American taxpayer.
Human Resources Flexibilities
 OPM implemented five new HR authorities enacted in the HSA through 
interim regulations. In February 2003, OPM published Voluntary 
Separation Incentive Program regulations that provided agencies with 
Governmentwide buyout authority. Upon OPM approval, agencies may use 
this authority as an important workforce reshaping tool in support of 
their human capital needs.
 In June 2003, OPM provided agencies with four additional 
flexibilities. These new authorities provide agencies with: increased 
flexibility in assessing applicants using alternative (category-based) 
rating and selection procedures; the ability to select qualified 
candidates for competitive service positions using direct-hire 
procedures; authority to pay or reimburse academic degree training 
costs from appropriated or other available funds and increased 
flexibility in academic degree training to address agency-specific 
human capital objectives; and revised voluntary early retirement 
authority criteria to address reshaping and restructuring issues. The 
authorities provide agencies with additional tools to recruit, retain, 
and reshape their workforce to meet critical mission goals and 
objectives. These five interim regulations allowed agencies immediate 
access to these new tools while simultaneously soliciting comments on 
potential program improvements. OPM is currently reviewing the comments 
received and will publish final regulations during the coming year.
BILLING CODE 6325-44-S

[[Page 72594]]

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 32,000 private defined 
benefit plans, including about 1,700 multiemployer plans.
 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.
Single-employer Program
 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 2002, the PBGC was 
trustee of about 3,100 plans and paid $1,537 million in benefits to 
about 362,000 people during 2002. Another 326,000 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 private defined benefit pension system has been under pressure for 
some time and has become a matter of public concern. In July 2003, the 
Administration proposed legislative changes to: (1) improve the 
accuracy of pension liability measurements by modifying the discount 
interest rate; (2) increase the transparency of pension plan 
information and make public pension underfunding information provided 
to PBGC for companies with over $50 million in underfunding; and (3) 
require immediate funding of accruals, benefit increases, and lump sum 
payments in certain situations involving a financially distressed 
company. The PBGC's guarantee limit would be fixed as of the date a 
plan sponsor files for bankruptcy. The Administration is exploring 
additional funding reforms to protect workers' retirement security.
 Other Administration proposals before the Congress are: (1) reduced 
premiums for new plans and plans of small employers; (2) expansion of 
the Missing Participants program to terminated multiemployer plans and 
terminated defined contribution plans; (3) acceleration of benefit 
determinations in terminated underfunded single-employer plans by 
streamlining the valuation of recoveries on due and unpaid 
contributions and employer liability claims and simplifying benefit 
determinations for substantial owners; and (4) payment of interest on 
premium refunds.
Multiemployer Program
 The multiemployer program (which covers about 9.5 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 less than single-employer guaranteed benefits.
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:
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

[[Page 72595]]

            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.
[sbull] Other Regulatory Simplifications and Relief
[sbull] 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.
[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] 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.
[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.
 In FY 2003, the PBGC issued a proposed rule that would: (1) remove 
requirements that might limit electronic filing with PBGC or electronic 
issuances to others; (2) simplify and consolidate PBGC's rules on 
filing and issuance methods, determining filing and issuance dates, and 
computing various periods of time for filings and issuances; and (3) 
provide rules for maintaining records by electronic means. (The PBGC 
implemented these changes in a final rule issued in early FY 2004.)
 The PBGC is continuing to review its regulations to look for further 
simplification opportunities. The PBGC's regulatory plan for October 1, 
2003, to September 30, 2004, consists of one significant regulatory 
action.
_______________________________________________________________________
PBGC

                              -----------

                          PROPOSED RULE STAGE

                              -----------

133. 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                                                           02/00/04
NPRM Comment Period End                                        04/00/04
Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None

[[Page 72596]]

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 72597]]

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 and sickness benefit program for 
railroad workers under the Railroad Unemployment Insurance Act. 
Regulations issued 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 nearly 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 systematic 
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 Railroad Retirement Board are designed 
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 and objectives 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 businesses.
_______________________________________________________________________
RRB

                              -----------

                          PROPOSED RULE STAGE

                              -----------

134. ELECTRONIC FILING OF APPLICATIONS AND CLAIMS FOR BENEFITS UNDER 
THE RAILROAD UNEMPLOYMENT INSURANCE ACT
Priority:


Other Significant


Legal Authority:


45 USC 355; 45 USC 362(l)


CFR Citation:


20 CFR 321


Legal Deadline:


None


Abstract:


The Railroad Retirement Board amends its regulations to add a new part 
321 to permit the electronic filing of applications and claims under 
the Railroad Unemployment Insurance Act 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 as a substitute for paper, 
when practicable. The addition of part 321 to the Board's regulations 
will provide our constituents with an option to electronically file 
applications and claims under the Railroad Unemployment Insurance Act 
via the Internet in accordance with the provisions of the Government 
Paperwork Elimination Act.


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 may result in modest savings in administrative 
costs due to the streamlining of procedures, the benefits are those 
extended to the agency's constituents by offering an alternative means 
to file for benefits.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 63041                                    11/07/03
NPRM Comment Period End                                        01/06/04
Final Rule                                                     03/00/04
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
Phone: 312 751-4945
TDD Phone: 312 751-4701
Fax: 312 751-7102
RIN: 3220-AB57
_______________________________________________________________________
RRB

                              -----------

                            FINAL RULE STAGE

                              -----------

135. 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

[[Page 72598]]

applications for annuity or lump sum payment 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            67 FR 77448                                    12/18/02
NPRM Comment Period End                                        02/18/03
Final Rule                                                     02/00/04
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
Phone: 312 751-4945
TDD Phone: 312 751-4701
Fax: 312 751-7102
RIN: 3220-AB55
BILLING CODE 7905-01-S

[[Page 72599]]

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 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 ensure 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; and
[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 its programs, and improving 
conditions for small business. All of SBA's rule concern small 
businesses and programs promoting small 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.
Prime Contracting Assistance; Contract Bundling
 SBA's regulations revise the definition of contract bundling to 
expressly include contracting bundling multiple award contract vehicles 
and task and delivery orders under such vehicles that were not 
currently addressed in existing regulations. The regulation requires 
procuring activities, well in advance of public notice, to coordinate 
their proposed acquisition strategies or plans contemplating award of a 
contract or order above specified dollar thresholds ($7 million for 
DOD, $5 million for NASA, DOE, and GSA, and $2 million for other 
civilian agencies) with agency Small Business Specialists (SBS). The 
SBS in turn, is required to notify the Office of Small and 
Disadvantaged Business Utilization (OSDBU) when those strategies 
include contract bundling that is unnecessary, unjustified, or not 
identified as such by the procuring activity. Activities are now 
required to provide bundling justification documentation to the agency 
OSDBU when the threshold for ``substantial bundling''` is met. In 
addition, the agencies' OSDBUs will perform certain oversight functions 
regarding bundled contracts. This regulation implements the 
recommendations of the Office of Management and Budget (OMB) in its 
report entitled ``Contract Bundling, A strategy for Increasing Federal 
Contracting Opportunities for Small Businesses.'' It has the potential 
of supplying millions of dollars of additional contracting 
opportunities to small businesses.
Small Business Size Standard; Restructuring of Size Standards
 SBA is drafting a proposed regulation to restructure small business 
size standards by reducing the number of different size standards 
levels. SBA has established size standards for each private sector by 
industry. Under the current structure, one of 37 different size 
standard levels has been established for 1,151 industries. Some users 
find the SBA's small business size standards complex and therefore 
difficult to understand and use for their purposes. Small businesses 
will benefit from a simpler set of size standards because they will 
find it easier to determine if they are a small business and they will 
be subject to fewer different size standards. Federal Government 
contracting officers and commercial lenders will benefit because a 
reduced number of size standard levels will be easier to administer in 
their contracting and loan activities.
_______________________________________________________________________
SBA

                              -----------

                          PROPOSED RULE STAGE

                              -----------

136. 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

[[Page 72600]]

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.


Risks:


This regulation poses no risks to the public health and safety or to 
the environment.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/03
Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


Businesses


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
137. [bull] SMALL BUSINESS SIZE STANDARDS; RESTRUCTURING OF SIZE 
STANDARDS
Priority:


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


Legal Authority:


15 USC 632


CFR Citation:


13 CFR 121


Legal Deadline:


None


Abstract:


The SBA proposes to restructure its small business size standards by 
reducing the number of different size standards levels. This 
restructuring will simplify the identification of which businesses are 
small and the use of size standards in Federal small business programs.


Statement of Need:


Some users find the SBA's small business size standards complex and 
therefore difficult to understand and use for their purposes. This 
apparent complexity may also discourage some small businesses from 
participating in Federal Government small business programs. To address 
this concern, the SBA intends to restructure and simplify its size 
standards by reducing the overall number of different size standards 
levels.


Summary of Legal Basis:


The Small Business Act (15 U.S.C. 632(a)) delegates to the SBA 
Administrator the responsibility for establishing small business 
definitions. The Act also requires that small business definitions vary 
to reflect industry differences.


Alternatives:


The SBA considered establishing a single size standard for a broad 
grouping of industries, such as entire industry sectors or subsector. 
The SBA does not believe this is a practical alternative, because the 
characteristics of industries within a sector or subsector vary too 
widely to support one size standard.


Anticipated Cost and Benefits:


Costs to the Federal Government will be negligible. There will be 
savings to the Federal Government because of reduced administrative 
costs. Neither the costs nor the savings are quantifiable. Small 
businesses will benefit because they will find it easier to determine 
if they are a small business and they will be subject to fewer 
different size standards. Federal Government contracting officers and 
commercial lenders will benefit because size standards will be easier 
to administer in their contracting and loan activities.


Risks:


Simplification may affect some businesses' eligibility for Federal 
Government small business programs. The SBA believes that they will be 
few in number. Also, new, simplified size standards are at risk of 
being considered inappropriate. The SBA is addressing these issues in 
the development of its proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/03
Regulatory Flexibility Analysis Required:


Yes


Government Levels Affected:


None


Agency Contact:
Gary M. Jackson
AA/Size Standards
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6618
Fax: 202 205-6390
Email: [email protected]
RIN: 3245-AF11
BILLING CODE 8025-01-S

[[Page 72601]]

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 12 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 three 
initiatives to improve public service.
One is 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. On February 03, 2003 (68 FR 5210), we published a final rule 
to do so, and also requested further comments from the public. We are 
preparing another final rule responding to the public comments we 
received.
 Furthermore, we plan to revise our regulations to permit an 
Administrative Law Judge to incorporate into the written decision, when 
wholly favorable, the findings and reasons stated orally at a hearing, 
if they remain applicable. We believe this revision may reduce the time 
needed to issue wholly favorable decisions after a hearing.
 In addition, we are including a proposed rule that would describe 
additional safeguards against inappropriate disclosure of personal 
information and set out special procedures concerning access to medical 
records.
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 three 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.
 Another final rule will provide for continued benefit payments to 
certain individuals who recover medically while participating in 
certain vocational rehabilitation programs.
 A proposed rule would revise several areas of our regulations on the 
Ticket to Work program to improve the support of disabled individuals 
who want and need assistance to return to the workforce.
Improve Stewardship
 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; some also reflect the goal to improve 
financial performance contained in the President's Management Agenda.
 We plan to clarify our rules for assigning Social Security Numbers to 
add evidentiary requirements for foreign academic students classified 
``F-1'' by the Bureau of Citizenship and Immigration Services.
 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 
developing final rules that reflect provisions of various laws intended 
to strengthen our oversight of the representative payee program. We 
have also included rules that provide us with additional tools to 
strengthen the integrity of the Social Security and SSI programs.
 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.
Simplify the SSI Program
 SSA is proposing two rules that would simplify our SSI regulations.
 One proposal 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.
 Another proposed rule would change our rules for deeming of income and 
resources from a stepparent to an eligible child when the child resides 
with a stepparent but not the natural or adoptive parent. We believe 
this change will simplify the rules concerning deeming under these 
circumstances.
_______________________________________________________________________
SSA

                              -----------

                          PROPOSED RULE STAGE

                              -----------

138. PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND INFORMATION (711P)
Priority:


Other Significant


Legal Authority:


5 USC 552; 5 USC 552a; 42 USC 1306(a); 42 USC 902(a)(5)


CFR Citation:


20 CFR 401.30; 20 CFR 401.45; 20 CFR 401.55; 20 CFR 401.150; 20 CFR 
401.180


Legal Deadline:


None


Abstract:


We propose to revise our privacy and disclosure rules to:


1. More fully describe the role and function of the Privacy Officer;


2. Describe safeguards against inappropriate disclosure of personal 
information when individuals request information about themselves by

[[Page 72602]]

electronic means (e.g., through the Internet);


3. Conform to special procedures on an individual's access to medical 
records; and


4. Add a new section to grant direct access to a minor's medical 
records by the minor's parent or legal guardian acting on the minor's 
behalf.


Statement of Need:


These revised regulations are necessary to:


1. Provide the expanded regulatory support for the existing 
responsibilities and functions of the Privacy Officer as required by 
the Privacy Act and related Office of Management and Budget (OMB) 
guidelines;


2. Articulate the safeguards that ensure the appropriate procedures for 
access to and disclosure of personally identifiable information in the 
electronic environment;


3. Conform the regulations to our practice and systems of records, 
which set out special procedures under which individuals whose medical 
records may potentially present an adverse effect may have access to 
this information; and


4. Conform to the special procedures in our systems of records for 
access to medical records.


Summary of Legal Basis:


Revisions are needed to incorporate into the regulations special 
procedures for providing individuals access to their medical records to 
ensure the ultimate disclosure of the records to the requesting 
individual, as set out in our systems of records.


Alternatives:


None.


Anticipated Cost and Benefits:


1. Revised role of Privacy Officer:


 Cost--None.


 Benefit--Increased public awareness of the privacy officer's role and 
responsibility in protecting the privacy and disclosure of the 
information SSA collects and maintains; general oversight to the Agency 
on privacy and disclosure activities.


2. Description of safeguards against inappropriate disclosure of 
personal information by electronic means:


 Cost--None.


 Benefit--Increase public awareness of the safeguards employed by SSA 
to maintain the security, confidentiality, and integrity of the 
information we collect and maintain.


3. Conform to special procedures on an individual's access to medical 
records; and


4. Add a new section to grant direct access to a minor's medical 
records by the minor's parent or legal guardian acting on the minor's 
behalf:


 Cost--None.


 Benefit--Regulatory guidelines will facilitate access for individuals 
whose medical records may have adverse effects.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           03/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Chris W. Johnson
Social Insurance Specialist
Social Security Administration
Office of Public Disclosure, Office of the General Counsel
1508 Woodlawn Drive
Baltimore, MD 21235
Phone: 410 965-8563

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AE88
_______________________________________________________________________
SSA
139. 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


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 overpayments 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) and the Office of Personnel 
Management (OPM) in order for SSA to participate in the Federal Salary 
Offset program. Treasury's regulation is 31 CFR 285.7; OPM's regulation 
is 5 CFR 550.1104.


Summary of Legal Basis:


SSA's use of the Federal Salary Offset program is authorized by 42 
U.S.C. 404(f), 42 U.S.C. and 5 U.S.C. 5514.


Alternatives:


None. SSA must have regulations, approved by OPM, in order to use 
Federal salary offset to collect debts owed by Federal employees. See 5 
U.S.C. 5514(b) and 5 C.F.R. 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                                                           03/00/04
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal

[[Page 72603]]

Agency Contact:
Edward Johns
Financial Management Analyst
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0392

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AE89
_______________________________________________________________________
SSA
140. REPRESENTATIVE PAYMENT UNDER TITLES II, VIII, AND XVI OF THE 
SOCIAL SECURITY ACT (949F)
Priority:


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


Legal Authority:


42 USC 401(j); 42 USC 902(a)(5); 43 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 421; 42 USC 425; 42 USC 1007; 42 USC 1010


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 404.2040(a); 20 
CFR 404.2041; 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 
416.650; 20 CFR 416.665; 20 CFR 416.1402; 20 CFR 408.601; 20 CFR 
408.610; 20 CFR 408.611; 20 CFR 408.615; 20 CFR 408.620; 20 CFR 
408.621; 20 CFR 408.622; 20 CFR 408.624; 20 CFR 408.625; 20 CFR 
408.630; 20 CFR 408.635; 20 CFR 408.640; 20 CFR 408.641; 20 CFR 
408.645; 20 CFR 408.650; 20 CFR 408.655; 20 CFR 408.660; 20 CFR 408.665


Legal Deadline:


None


Abstract:


Effective stewardship of SSA programs requires mechanisms to assure 
that benefits are used to meet the needs of beneficiaries judged 
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 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 1 month the deferral or 
suspension of direct payment of benefits pending selection of a payee; 
(2) providing stricter standards in determining the fitness of 
representative payee applicants to manage benefit payments on behalf of 
beneficiaries; (3) requiring SSA to repay the beneficiary or an 
alternate payee, an amount equal to any misused funds resulting from 
SSA's negligent failure to investigate or monitor a representative 
payee; (4) granting certain payees the authority to collect a fee from 
beneficiaries; (5) changing how SSA treats persons with a drug 
addiction or an alcohol condition; 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 
201 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            68 FR 55323                                    09/25/03
NPRM Comment Period End                                        11/24/03
Final Action                                                   06/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Governmental Jurisdictions, Organizations


Government Levels Affected:


Local, State


Agency Contact:
Betsy Byrd
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-7981

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF83
_______________________________________________________________________
SSA
141. ELIMINATION 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.

[[Page 72604]]

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 
households 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 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                                                           01/00/04
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Albert Fatur
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9855

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF84
_______________________________________________________________________
SSA
142. EVIDENCE REQUIREMENT FOR ASSIGNMENT OF SOCIAL SECURITY NUMBERS 
(SSNS); ASSIGNMENT OF SSNS TO FOREIGN STUDENTS (960P)
Priority:


Other Significant


Legal Authority:


42 USC 405

[[Page 72605]]

CFR Citation:


20 CFR 422.105; 20 CFR 422.107


Legal Deadline:


None


Abstract:


We propose to clarify our rules for assigning Social Security Numbers 
(SSNs) to foreign academic students in the Bureau of Citizenship and 
Immigration Services (BCIS, formerly the Immigration and Naturalization 
Service or INS) classification status F-1. Specifically, we propose to 
add additional evidentiary requirements for F-1 students who apply for 
SSNs. In addition to meeting SSA's requirement to provide evidence of 
age, identity, legal alien status, and work authorization, an F-1 
student who does not have a valid BCIS-issued Employment Authorization 
Document (EAD) will be required to present evidence that on-campus 
employment has been secured before we will assign an SSN.


Statement of Need:


These revised regulations are necessary to further enhance the 
integrity of SSA's enumeration processes for assigning SSNs. By 
clarifying the evidence requirements for assignment of SSNs, we intend 
to reduce the opportunity for fraud through misuse and/or improper 
attainment of SSNs.


Summary of Legal Basis:


None.


Alternatives:


We considered just requiring schools to certify the number of on-campus 
jobs available (including as a subset those being held for F-1 
students) and the number of F-1 students who want to work. However, we 
do not believe it adequately addresses our need to ensure that the 
individual student applicant for an SSN is working or has obtained a 
job before we will assign him or her an SSN. As such, this alternative 
would do little to achieve our objective in making the regulations 
changes, which is to reduce the opportunity for fraud through misuse 
and/or improper attainment of SSNs.


Anticipated Cost and Benefits:


The program costs associated with these revised regulations are 
negligible. Also, there are negligible administrative costs (i.e., less 
than 25 work years and less than $2 million). Benefits to SSA include 
enhancing the integrity of SSA's enumeration processes and helping to 
alleviate the proliferation of SSNs thereby resulting in fewer 
opportunities for SSN fraud, including the fraud associated with 
identity theft.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           12/00/03
Final Action                                                   08/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF87
_______________________________________________________________________
SSA
143. AMENDMENTS TO THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM 
(967P)
Priority:


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


Legal Authority:


42 USC 902(a)(5)


CFR Citation:


20 CFR 411.115; 20 CFR 411.125 to 411.140; 20 CFR 411.150 to 411.155; 
20 CFR 411.171; 20 CFR 411.350 to 411.375; 20 CFR 411.385 to 411.395; 
20 CFR 411.500 to 411.510; 20 CFR 411.525 to 411.565; 20 CFR 411.575 to 
411.585


Legal Deadline:


None


Abstract:


These proposed rules are intended to amend the final rules implementing 
the Ticket to Work and Self-Sufficiency Program under section 1148 of 
the Social Security Act: to expand beneficiary eligibility to receive 
tickets under this program; to clarify the rules for assignment of a 
beneficiary ticket to a State vocational rehabilitation (VR) agency; to 
revise the rules for payment when a beneficiary receives services from 
both a State VR agency and an employment network (EN); and, consistent 
with the Commissioner's authority in section 1148(h) of the Act, to 
revise the rules for milestone and outcome payments to ENs, in order to 
increase the incentives for providers of employment and other support 
services to participate in this program.


Statement of Need:


This proposed regulatory action is necessary to respond to our 
experience and recommendations we have received since we began 
implementation of the Ticket to Work and Self-Sufficiency Program in 
February 2002, in order to increase the incentives for providers of 
employment services, vocational rehabilitation services, and other 
support services to participate in this program, and to expand the 
options available to beneficiaries with disabilities to obtain services 
to assist them to go to work and attain self-sufficiency.


Summary of Legal Basis:


None.


Alternatives:


We considered not revising the current regulations implementing the 
Ticket to Work program. However, we believe that these revisions to 
eligibility to receive a ticket, to clarify the rules for assignment of 
a ticket to a State VR agency, and to amend the rules for paying ENs 
are necessary to increase participation in the Ticket to Work program 
by providers of services and by beneficiaries with disabilities, in 
order to ensure that these beneficiaries can seek the services 
necessary to obtain and retain employment and reduce their dependency 
on cash benefit programs.


Anticipated Cost and Benefits:


We anticipated initial costs to increase due to up-front payments to 
ENs, and potential savings in later years as ENs are encouraged to 
serve additional beneficiaries and assist them to achieve self-
sufficiency and reduce their dependency on cash benefit programs, 
including the Supplemental Security Income and Social Security 
Disability Insurance programs.


Risks:


At this time, we have not identified any risks associated with this 
proposal.

[[Page 72606]]

Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           02/00/04
Final Action                                                   10/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Agency Contact:
Geoffrey Funk
Social Insurance Specialist
Social Security Administration
Office of Employment Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9010

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF89
_______________________________________________________________________
SSA
144. [bull] ELIMINATION OF PARENT-TO-CHILD DEEMING FOR INDIVIDUALS WHO 
NO LONGER MEET THE DEFINITION OF SPOUSE OF THE NATURAL OR ADOPTIVE 
PARENT (793P)
Priority:


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


Legal Authority:


Sec 1614(f)(2) of the Social Security Act


CFR Citation:


20 CFR 416.1101; 20 CFR 416.1160; 20 CFR 416.1202; 20 CFR 416.1851; 20 
CFR 416.1856


Legal Deadline:


None


Abstract:


We propose to change the Supplemental Security Income (SSI) parent-to-
child deeming rules to no longer consider the income and resources of a 
stepparent when an eligible child resides in the household with a 
stepparent, but not his or her natural or adoptive parent. We will 
clarify that a stepparent no longer meets the definition of a 
``parent'' when his or her spouse dies or leaves the household. Thus, 
an eligible child is not subject to deeming from a stepparent unless 
the child lives with both his or her natural or adoptive parent and the 
stepparent. We also propose changing the age at which an individual is 
no longer considered an ineligible child for purposes of deeming from 
21 to 22. We believe this change will simplify our rules for both the 
public and our public contact employees.


Statement of Need:


The U.S. Court of Appeals, Second Circuit, ruled on a case involving a 
natural parent who abandoned the family home leaving her spouse with 
sole physical custody of an eligible child. Social Security 
Acquiescence Ruling 99-1(2) currently applies the Court's decision to 
the States of Connecticut, Vermont, and New York. The proposed rules 
will set uniform national policy with respect to this issue. Further, 
changing the definition of ``ineligible child'' for purposes of deeming 
will make uniform all regulatory definitions of ``child'' for SSI 
purposes. This will simplify our rules, making them less cumbersome to 
administer and easier for the public to understand and follow.


Summary of Legal Basis:


None.


Alternatives:


None.


Anticipated Cost and Benefits:


We estimate that the program costs and administrative costs for these 
regulatory changes would be negligible.


Risks:


These proposed rules will ensure our parent-to-child deeming rules are 
consistent with respect to our current regulatory definition of 
``parent'' and ``child.'' Policy will uniformly be set nationwide and 
will make our rules less difficult for the public to understand.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM                                                           06/00/04
Final Action                                                   02/00/05
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Sean Balser
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-7908

Kenneth A. Brown
Social Insurance Specialist
Social Security Administration
Office of Program Benefits
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9772

Richard M. Bresnick
Paralegal Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1758
RIN: 0960-AF96
_______________________________________________________________________
SSA

                              -----------

                            FINAL RULE STAGE

                              -----------

145. ADMINISTRATIVE WAGE GARNISHMENT (TO REPAY A DEBT OWED TO THE 
SOCIAL SECURITY ADMINISTRATION) (724F)
Priority:


Other Significant


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 416.590; 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

[[Page 72607]]

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.


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            67 FR 69164                                    11/15/02
NPRM Comment Period End                                        01/14/03
Final Action                                                   02/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


Federal, Local, State, Tribal


Agency Contact:
Edward Johns
Financial Management Analyst
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0392

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AE92
_______________________________________________________________________
SSA
146. 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:


These final rules consider and respond to public comments received on 
final rules with request for comment that we published on February 3, 
2003, to authorize us to conduct hearings before an Administrative Law 
Judge (ALJ) at which a party or parties to the hearing and/or a witness 
or witnesses may appear before the ALJ by video teleconference (VTC). 
The final rules with request for comment 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 requested public comment on the final rules of February 3, 2003, 
because they made a significant change in a provision included in our 
notice of proposed rulemaking for these rules. Unlike the proposed 
rules, which would have given claimants the right to veto the use of 
VTC to take their own testimony and the testimony of expert witnesses, 
the final rules with request for comment give claimants the right to 
veto the use of VTC only for the purpose of taking their own testimony.


Statement of Need:


We received public comments on the final rules with request for 
comment. We must publish final rules to state our responses to the 
comments and our decision regarding whether to make changes in the 
final rules of February 3, 2003, which authorized our use of VTC to 
conduct appearances at ALJ hearings effective March 5, 2003.


Summary of Legal Basis:


None.


Alternatives:


None.


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 Rule with 68 FR 5210r Comment                            02/03/03
Final Rule Effective                                           03/05/03
Final Action                                                   12/00/03
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 72608]]

Agency Contact:
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AE97
_______________________________________________________________________
SSA
147. 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 404.1500, 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 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:


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: 5-year total may not be equal to the sum 
of the annual totals due to rounding-out.)


(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                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Nancy Torkas
Policy Specialist
Social Security Administration
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1744

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF28
_______________________________________________________________________
SSA
148. CONTINUATION OF BENEFIT PAYMENT TO CERTAIN INDIVIDUALS WHO ARE 
PARTICIPATING IN A PROGRAM OF VOCATIONAL REHABILITATION SERVICES, 
EMPLOYMENT SERVICES, OR OTHER SUPPORT SERVICES (925F)
Priority:


Other Significant


Legal Authority:


42 USC 902(a)(5)


CFR Citation:


20 CFR 404.316; 20 CFR 404.327 (New); 20 CFR 404.328 (New); 20 CFR 
404.337; 20 CFR 404.352; 20 CFR 404.902; 20 CFR 404.1586; 20 CFR 
404.1596; 20 CFR 404.1597; 20 CFR 416.1321; 20 CFR 416.1331; 20 CFR 
416.1338; 20 CFR 416.1402


Legal Deadline:


None

[[Page 72609]]

Abstract:


These final rules revise the regulations that provide for the 
continuation of benefit payments to certain individuals who recover 
medically while participating in a vocational rehabilitation program 
with a State vocational rehabilitation agency. We are revising these 
regulations because of statutory amendments, which extend eligibility 
for these continued benefit payments to certain individuals who recover 
medically while participating in another appropriate program of 
vocational rehabilitation services. These include individuals 
participating in the Ticket to Work and Self-Sufficiency Program or 
another program of vocational rehabilitation services, employment 
services, or other services approved by the Commissioner of Social 
Security.


Prior to November 1991, the Social Security Act provided for the 
continuation of payment of Social Security Disability Insurance and 
Supplemental Security Income disability and blindness benefits to 
individuals whose disability or blindness ended for medical reasons 
while they were participating in an approved State vocational 
rehabilitation program under title I of the Rehabilitation Act of 1973, 
if the Commissioner of Social Security determined that completion or 
continuation of the program would increase the likelihood of the 
individual's permanent removal from the disability benefits rolls. The 
Omnibus Budget Reconciliation Act of 1987 extended eligibility for 
continued benefits to individuals who receive Supplemental Security 
Income benefits based on blindness. (We implemented this change by 
issuing operating instructions effective April 1, 1988, the effective 
date of the amendment.) The Omnibus Budget Reconciliation Act of 1990 
extended eligibility for continued benefits to individuals 
participating in an approved non-State vocational rehabilitation 
program at the time their disability ended. (We implemented this change 
by issuing operating instructions effective November 1991, the 
effective date of the amendments.) The Personal Responsibility and Work 
Opportunity Reconciliation Act of 1996 requires the redetermination of 
eligibility based on disability of individuals who attain age 18, based 
on the rules for determining initial eligibility for adults. These 
redeterminations are not continuing disability reviews, however, we are 
revising our regulations to provide that an individual whose disability 
has ended as a result of an age--18 redetermination may qualify for 
continued benefits based on participation in an approved program and 
increased likelihood of permanent removal from the disability rolls, if 
the individual meets all other requirements for continued benefits. The 
Ticket to Work and Work Incentives Improvement Act of 1999 authorizes 
continued benefits for a person who medically recovers while 
participating in a program consisting of the Ticket to Work program or 
another program of vocational rehabilitation services, employment 
services, or other support services approved by the Commissioner of 
Social Security, provided that the other requirements for benefit 
continuation are met.


These rules will explain what we mean by ``an appropriate program of 
vocational rehabilitation services, employment services, or other 
support services.'' They will explain when an individual will be 
considered to be ``participating'' in the program. They will explain 
how we will determine whether an individual's completion of or 
continuation in an appropriate program of vocational rehabilitation 
services, employment services, or other support services will increase 
the likelihood that the individual will not have to return to the 
disability rolls. They will also explain that, for students age 18 
through 21, ``an appropriate program of vocational rehabilitation 
services, employment services, or other support services'' includes an 
individualized education plan developed under polices and procedures 
approved by the Secretary of Education for assistance to States for the 
education of child under the Individuals with Disabilities Act, as 
amended.


Statement of Need:


These final regulations are necessary to conform our regulations to 
amendments enacted in the Ticket to Work and Work Incentives 
Improvement Act of 1999, as well as the amendments enacted in the 
Omnibus Budget Reconciliation Act of 1990 and the Omnibus Budget 
Reconciliation Act of 1987; and as the result of a provision enacted in 
the Personal Responsibility and Work Opportunity Reconciliation Act of 
1996.


Summary of Legal Basis:


None.


Alternatives:


None.


Anticipated Cost and Benefits:


For the 5-year period from fiscal year 2004 through 2008, the estimated 
effects on Federal Supplemental Security Income payments for increased 
payments for children range from $4 million in fiscal year 2004 to $46 
million in fiscal year 2008. The estimated impact on the Federal share 
of Medicaid payments during this 5-year period range from $3 million in 
fiscal year 2004 to $41 million in fiscal year 2008.


Risks:


At this time, we have not identified any risks associated with this 
proposal.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
NPRM            68 FR 45180                                    08/01/03
NPRM Comment Period End                                        09/30/03
Final Action                                                   04/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Geoffrey Funk
Social Insurance Specialist
Social Security Administration
Office of Employment Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9010

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF86
_______________________________________________________________________
SSA
149. ADMINISTRATIVE REVIEW PROCESS; INCORPORATION BY REFERENCE OF ORAL 
FINDINGS OF FACT AND RATIONALE IN WHOLLY FAVORABLE WRITTEN DECISIONS 
(964I)
Priority:


Other Significant


Legal Authority:


42 USC 405(a); 42 USC 405(b); 42 USC 902(a)(5); 42 USC 1383

[[Page 72610]]

CFR Citation:


20 CFR 404.953; 20 CFR 416.1453


Legal Deadline:


None


Abstract:


These interim final rules revise our regulations to provide that if an 
Administrative Law Judge (ALJ) enters a wholly favorable, oral decision 
into the record of a hearing, the ALJ may subsequently issue a written 
decision that gives the findings and reasons for the decision by 
incorporating by reference the findings and reasons stated orally at 
the hearing, provided that the ALJ does not determine subsequent to the 
hearing that the oral findings and reasons should be changed.


Statement of Need:


In fiscal year 2002, we announced a number of short-term actions to 
reduce delays in processing requests for ALJ hearings. One of these 
actions was to allow ALJs to issue oral decisions from the bench at the 
close of the hearing. We have found that ALJs are not frequently 
issuing oral decisions from the bench because of the duplication of 
work involved in issuing the oral decision and then subsequently 
issuing a written decision that fulfills existing provisions of our 
regulations requiring ALJs to issue written decisions that give the 
findings of fact and the reasons for the decision. We believe we can 
make it easier to use the bench decision procedure to reduce the time 
required to issue wholly favorable decisions by amending our 
regulations to explicitly authorize ALJs to issue wholly favorable 
written decisions that incorporate by reference the findings and 
rational stated orally in a bench decision.


Summary of Legal Basis:


None.


Alternatives:


Interpret our existing regulations to allow ALJs to issue written, 
wholly favorable decisions that give the findings of fact and rationale 
for the decision by incorporating by reference the findings and 
rationale stated in an oral decision that the ALJ entered into the 
record at the hearing.


Anticipated Cost and Benefits:


Improved public service by facilitating use of the oral decision 
procedure to reduce the time required to issue wholly favorable 
decisions.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                                 DFR Cite

_______________________________________________________________________
Interim Final Rule                                             02/00/04
Final Action                                                   09/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AF92
BILLING CODE 4191-02-S

[[Page 72611]]

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 
Banks also acquire mortgage assets from members as a means of advancing 
their housing finance mission. 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 2004 that would be required to be included in a 
regulatory plan.
The Finance Board's highest regulatory priorities during 2004 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 consider regulations that will:
[sbull] Revise the acquired member asset (AMA) regulation to place 
            greater responsibility with each Bank to design and manage 
            its AMA program, subject to ongoing supervisory review by 
            the Finance Board;
[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;
[sbull] Improve the operations and efficiency of the Affordable Housing 
            Program by more clearly delineating the Banks' 
            responsibilities for program administration and for 
            satisfying the statutory directive that the subsidy benefit 
            very low-income, low-income, and moderate-income 
            households;
[sbull] Improve public disclosure by the Banks including addressing the 
            requirements of the Securities Exchange Act of 1934, as 
            that Act is interpreted and applied by the SEC; and
[sbull] Develop, based on its analysis of recently solicited comments 
            and other research, an appropriate regulatory response to 
            possible renewed requests that a single financial 
            institution be permitted to become a member of more than 
            one Bank.
BILLING CODE 6725-01-S

[[Page 72612]]

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, secure, market-driven, and 
nondiscriminatory ocean transportation system in an environment free of 
unfair foreign maritime trade practices and market-distorting 
activities. 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.
 The Ocean Shipping Reform Act of 1998 (OSRA) 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 2003, along with current requirements applicable to 
agreement carriers' filing of operating data and minutes of meetings. 
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, in calendar year 2003, will be assessing public 
comments on changes it previously proposed.
 The principal objective or priority of the Agency's current regulatory 
plan will be to continue to assess major existing regulations for 
continuing need, burden on the regulated industry, and clarity. The 
Commission issued its 2-year study of OSRA in September 2001. It still 
is possible that findings and conclusions from that report could result 
in consideration of specific issues for rulemaking proposals.
 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 72613]]

FEDERAL TRADE COMMISSION (FTC)
Statement of Regulatory Priorities
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.
 After amending the Telemarketing Sales Rule (TSR), 16 CFR part 310, 68 
Fed. Reg. 4580 (Jan. 29, 2003), to establish a national ``do not call'' 
registry, the Commission opened the registry on June 26, 2003. 
Consumers can register for free in two ways: online at DONOTCALL.GOV or 
by telephone at 1(888) 382-1222. As of October 1, 2003, it became 
illegal for most telemarketers to call a number listed on the registry. 
Also, the Commission issued additional amendments on July 31, 2003, 
imposing fees on entities accessing the ``do not call'' registry. See 
68 FR 45134 (July 31, 2003). The rule changes require sellers to pay 
the annual fee for access to the national registry; impose an annual 
fee of $25 per area code, with the maximum annual fee of $7,375; allow 
access to up to five area codes for free; and set October 1, 2003, as 
the effective date for the ``do-not-call'' provisions of the amended 
TSR. To comply with the amended TSR's ``do not call'' provisions by 
this effective date, all covered sellers are required to access the 
registry for the first time between September 1 and September 30, 2003.
Industry Self-Regulation, Textile Leniency Policy and Compliance 
Partnerships With Industry
 The Commission continues to be committed to protecting consumers by 
means that burden businesses the least. To that end, it has encouraged 
industry self-regulation, developed a corporate leniency policy for 
certain rule violations, and established compliance partnerships where 
appropriate.
 The Commission has issued reports that encourage industry self-
regulation in several areas. In the entertainment industry, the 
Commission has urged self-regulation for violent media products 
marketed to children. See, e.g.,Federal Trade Commission, Marketing 
Violent Entertainment to Children: A Twenty-One Month Follow-Up Review 
of Industry Practices in the Motion Picture, Music Recording & 
Electronic Game Industries (June 2002), http://www.ftc.gov/reports/
violence/mvecrpt0206.pdf. The Commission also continues to encourage 
companies in the alcohol industry to engage in self-regulation to 
ensure that advertising for products containing alcohol is not directed 
at underage youths.
 In addition, in the weight-loss product advertising area, the 
Commission has proposed a strengthened self-regulatory response from 
the industry and more media responsibility to address the widespread 
problem of blatantly false efficacy claims. Also, with respect to the 
Children's Online Privacy Protection Act (COPPA), the Commission has 
approved the safe harbor programs of three organizations whose self-
regulatory guidelines and programs protect children's privacy to the 
same or greater extent as COPPA.
 Recently, the Commission announced the Textile Corporate Leniency 
Policy Statement for minor and inadvertent violations of the Textile or 
Wool Rules that are self-reported by the company. 67 FR 71566 (Dec. 2, 
2002). Generally, the purpose of the Textile Corporate Leniency Policy 
is to help increase overall compliance with the rules while also 
minimizing the burden on business of inadvertent labeling errors that 
are not likely to cause injury to consumers. Under this policy, the 
Commission announced the factors that staff will consider in allowing 
the mislabeled goods to be sold without relabeling. The policy follows 
the Commission's Civil Penalty Leniency Program for small businesses, 
but is not limited to small businesses or situations involving civil 
penalties.
 The Commission has also engaged industry in compliance partnerships in 
at least two areas involving the funeral and franchise industries. 
Specifically, the Commission's Funeral Rule Offender Program (FROP), 
conducted in

[[Page 72614]]

partnership with the National Association of Funeral Directors (NAFD), 
is designed to educate funeral home operators found in violation of the 
requirements of the Funeral Rule, 16 CFR part 453, so that they can 
meet the rule's disclosure requirements. Approximately 200 funeral 
homes have participated in the program since its inception in 1996. In 
addition, the Commission established the Franchise Rule Alternative Law 
Enforcement Program in partnership with the International Franchise 
Association (IFA), a nonprofit organization that represents both 
franchisors and franchisees. This program is designed to assist 
franchisors found to have a minor or technical violation of the 
Franchise Rule, 16 CFR part 436, in complying with the rule. 
(Violations involving fraud or other Section 5 violations are not 
candidates for referral to the program.) The IFA trains the franchisor 
how to comply with the rule and monitors its business for a period of 
years. Where appropriate, the program will offer franchisees the 
opportunity to mediate claims arising from the law violations. Since 
December 1998, eleven companies have agreed to participate in the 
program.
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. For many rules this has resulted in 
more frequent reviews than is generally 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 nor 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 2003 Reviews
 In early 2004, the Commission plans to publish a Federal Register 
notice announcing which rules and guides it will begin to review that 
year. 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.,68 FR 2465 (Jan. 17, 2003).
 All of the new 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. During 2003, the Commission announced its 
intention to begin the review of one rule regarding Rules and 
Regulations Under the Hobby Protection Act, 16 CFR part 304, two 
industry guides regarding Guides Concerning Use of Endorsements and 
Testimonials in Advertising, 16 CFR part 255, and Tire Advertising and 
Labeling Guides, 16 CFR part 228, and the Statement of General Policy 
or Interpretations Under the Fair Credit Reporting Act, 16 CFR part 
600.
 We discuss below some of the highlights of the actions already taken 
or that we propose to take.
Rules and Regulations Under the Hobby Protection Act: The Commission 
requested public comments on March 3, 2003, about the economic impact 
and benefits of the Rules and Regulations Under the Hobby Protection 
Act and whether changes in the relevant technologies--such as e-mail 
and the Internet--affect the Rule since it was issued. See68 FR 9856 
(Mar. 3, 2003). After assessing public comments, staff expects to 
forward its recommendation to the Commission by the end of 2003.
Guides Concerning Use of Endorsements and Testimonials in Advertising: 
The staff expects to forward to the Commission its recommendation that 
the Commission issue a notice during late 2003 or early 2004, seeking 
public comment about, among other things, whether there is a continuing 
need for the Guides Concerning Use of Endorsements and Testimonials in 
Advertising and what changes, if any, should be made to the Guides to 
increase the benefits of the Guides.
Tire Advertising and Labeling Guides: The Commission issued a notice 
seeking public comment about, among other things, whether there is a 
continuing need for the Tire Advertising and Labeling Guides and what 
changes, if any, should be made to the Guides to increase the benefits 
of the Guides to purchasers. 68 FR 50984 (Aug. 25, 2003).
Statement of General Policy or Interpretations Under the Fair Credit 
Reporting Act: Staff plans to recommend that the Commission issue a 
notice requesting comments on the Statement of General Policy or 
Interpretations Under the Fair Credit Reporting Act in Spring 2004, or 
after the Congress amends the Fair Credit Reporting Act because part of 
the Act expires on December 31, 2003.
Ongoing Reviews
 As part of the Commission's ten-year review program, in 2003 the 
Commission continued reviews of six rules. First, in the review of the 
R-Value Rule for home insulation, 16 CFR part 460, the Commission 
reviewed the comments received on the Advance Notice of Proposed 
Rulemaking (ANPRM) and issued a notice of Proposed Rulemaking (NPRM) 
which announced a number of proposed amendments to the rule. See 68 FR 
41872 (July 15, 2003). After assessing the public comments, staff 
expects to forward its recommendation to the Commission regarding 
substantive amendments to the Rule by early 2004.
 Second, with respect to the Premerger Notification and Report Form, in 
addition to the final rules issued by the Commission and described 
under Final Actions below, in late 2003, the staff anticipates 
forwarding its recommendation to the Commission to allow parties to 
file the premerger notification and report form electronically via the 
Internet. Staff also plans to forward its recommendation to the 
Commission in spring or summer 2004 concerning issuance of an NPRM to 
revise its treatment of non-corporate entities.
 Third, in the review of the Franchise Rule, 16 CFR part 436, the 
Commission accepted comments on an NPRM with the text of a revised rule 
until December

[[Page 72615]]

21, 1999, and rebuttal comments until January 31, 2000. The proposal 
addresses issues that include: (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 early 2004.
 Fourth, 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 this 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 based information and 
entertainment services. The most recent workshop 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 during the spring of 2004.
 Fifth, 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 during the winter of 2004.
 Finally, the Commission began its regulatory review of certain aspects 
of the Funeral Industry Practices Rule (Funeral Rule or Rule), 16 CFR 
part 453, in 1999. 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 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. See64 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 subsequently held to explore issues raised in the 
comments submitted. Staff expects to forward its recommendation to the 
Commission early in 2005.
Final Actions
 Since publication of the 2002 Regulatory Plan, the Commission has 
taken final actions on three rulemakings. After amending the 
Telemarketing Sales Rule (TSR), 16 CFR part 310 (68 FR 4580, Jan. 29, 
2003), to establish a national ``do not call'' registry, the Commission 
opened the registry on June 26, 2003. Consumers can register for free 
in two ways: online at DONOTCALL.GOV or by telephone at 1(888) 382-
1222. As of October 1, 2003, it became illegal for most telemarketers 
to call a number listed on the registry. Also, the Commission issued 
additional amendments on July 31, 2003, that imposed fees on entities 
accessing the ``do not call'' registry. See68 FR 45134 (July 31, 2003). 
The rule changes required sellers to pay the annual fee for access to 
the national registry; imposed an annual fee of $25 per area code, with 
the maximum annual fee of $7,375; allowed access to up to five area 
codes for free; and set October 1, 2003, as the effective date for the 
``do not call'' provisions of the amended TSR. To comply with the 
amended TSR's ``do not call'' provisions by this effective date, all 
covered sellers were required to access the registry for the first time 
between September 1 and September 30, 2003.
 For the Premerger Notification Rules and Report Form, the Commission 
announced final amendments to parts 801 and 803 of the interim rules on 
January 17, 2003. On February 1, 2001, the Commission published interim 
and proposed rules amending the Hart-Scott-Rodino Rules (HSR Rules) 
contained in 16 CFR parts 801, 802, and 803. The interim rules took 
effect upon publication and implemented amendments to section 7A of the 
Clayton Act, 66 FR 8679 (Feb. 1, 2001). The proposed rules set forth 
other changes improving and updating the HSR Rules. 66 FR 8723 (Feb. 1, 
2001). This current action was in response to comments that had been 
received during the comment period for the interim final rules. The 
Commission also received other comments in response to the February 1, 
2001, Federal Register notices that were not relevant to the changes 
promulgated by either the interim or proposed rules issued during 2001. 
These additional comments remain under consideration and may be 
addressed by future rulemaking.
 For the Appliance Labeling Rule, the Commission granted a conditional 
exemption from certain EnergyGuide testing and labeling requirements on 
certain home appliances for the remainder of the calendar year of 2003 
to allow manufacturers to use the new (J1) test procedure immediately 
instead of waiting until the beginning of 2004. See68 FR 36458 (June 
18, 2003). The Commission also amended the Rule to require explanatory 
language on EnergyGuide labels for all models beginning January 1, 
2004.
Summary
 In both content and process, the FTC's ongoing and proposed regulatory 
actions are consistent with the President's priorities. The actions 
under consideration inform and protect consumers and reduce the 
regulatory burdens on businesses. The Commission will continue working 
toward these goals. The Commission's ten-year review program is 
patterned after provisions in the Regulatory Flexibility

[[Page 72616]]

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 Telemarketing Sales Rule, 16 CFR part 310 
(2003), is consistent with the President's Statement of Regulatory 
Philosophy and Principles, Executive Order 12866, section 1(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, section 1.
II. REGULATORY ACTIONS
 The Commission does not plan to propose any rules that would be a 
``significant regulatory action'' under the definition in Executive 
Order 12866.
BILLING CODE 6750-01-S

[[Page 72617]]

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 regulatory priorities for the next fiscal year reflect the 
Commission's commitment to upholding the principles of IGRA. The gaming 
industry changes rapidly with advancements in machine technology. It is 
crucial for the vitality of Indian gaming that regulators have the 
ability to respond quickly to these changes. To that end, the 
Commission has decided that the development of technical standards for 
game classifications, gaming machines, and related gaming systems is an 
important initiative for the promotion and protection of tribal gaming.
 Additionally, the Commission will be making technical amendments to 
the minimal internal control standards. These amendments will correct 
isolated problems that have been brought to the Commission's attention 
by tribal gaming operators and regulators.
 The Commission has been innovative in using active outreach efforts to 
inform its generic policy development and its rulemaking efforts. For 
example, the Commission has had great success in using regional 
meetings, both formal and informal, with tribal governments to gather 
views on current and proposed Commission initiatives. The Commission 
anticipates that these consultations with regulated tribes will play an 
important role in the development of technical standards.
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NIGC

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                          PROPOSED RULE STAGE

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150. [bull] TECHNICAL STANDARDS FOR GAME CLASSIFICATIONS, GAMING 
MACHINES, AND GAMING SYSTEMS
Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


25 USC 2706


CFR Citation:


25 CFR 501


Legal Deadline:


None


Abstract:


It is necessary for the National Indian Gaming Commission (NIGC) to 
promulgate regulations establishing technical standards for game 
classifications because of the distinction between class II and class 
III gaming set forth in IGRA. Technical changes make it difficult for 
regulators to keep up with the gaming industry. By establishing 
technical standards, tribal gaming commissions, the primary regulators 
of tribal gaming, will more easily be able to distinguish between class 
II and class III machines. Further, it is necessary for the Commission 
to establish technical standards for the actual operation of gaming 
machines and systems and the equipment related to their operation.


Statement of Need:


Technical standards are needed to assure that regulators can determine 
game classifications and so that machine games are operated in a manner 
that ensures uniformity and integrity in tribal gaming.


Summary of Legal Basis:


It is the goal of the NIGC to provide regulation of Indian gaming to 
shield it from organized crime and other corrupting influences as well 
as assuring that gaming is conducted fairly and honestly. (25 U.S.C. 
2702). The Commission is charged with the responsibility of monitoring 
gaming conducted on Indian lands. (25 U.S.C. 2706(b)(1)). 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 these 
sections of the statute to authorize the promulgation of technical 
standards for game classifications and for gaming machines to ensure 
uniformity and integrity in tribal gaming.


Alternatives:


The Commission can either: (1) issue a rule establishing technical 
standards for game classifications and gaming machines, or (2) continue 
evaluating classifications on a case-by-case basis.


Anticipated Cost and Benefits:


The development of technical standards will reduce the cost of 
regulation to the Federal Government. Additionally, technical standards 
will aid tribal governments in the regulations of their gaming 
activities as well as prevent loss associated with defective or 
substandard gaming devices. The only anticipated cost will be to gaming 
machine manufacturers.


Risks:


There are no known risks to this regulatory action.


Timetable:
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Action                                 DFR Cite

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NPRM                                                           04/00/04
Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Tribal


Federalism:


 Undetermined


Agency Contact:
William F. Grant
Senior Attorney
National Indian Gaming Commission
Suite 9100
1441 L Street NW.
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
RIN: 3141-AA29
BILLING CODE 7565-01-S
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