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




                          The Regulatory Plan


____________________________________________________________________

[[Page 64085]]



                INTRODUCTION TO THE FALL 2005 REGULATORY PLAN

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

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

                Federal Regulatory Policy

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

                Effective regulatory policy is not uniformly pro-
                regulation or anti-regulation. It begins with the 
                authority granted under the law. Within the discretion 
                available to the regulating agency by its statutory 
                authority, agencies apply a number of principles 
                articulated in Executive Order 12866 (as well as other 
                orders, such as Executive Order 13211, ``Actions 
                Concerning Regulations That Significantly Affect Energy 
                Supply, Distribution, or Use,'' signed May 18, 2001, 66 
                FR 28355), in order to design regulations that achieve 
                their ends in the most efficient way. This means 
                bringing to bear on the policy problem sound economic 
                principles, the highest quality information, and the 
                best possible science. This is not always an easy task, 
                as sometimes economic and scientific information may 
                point in very different directions, and therefore 
                designing regulations does not mean just the rote 
                application of quantified data to reach policy 
                decisions. In making regulatory decisions, we expect 
                agencies to consider not only benefit and cost items 
                that can be quantified and expressed in monetary units, 
                but also other attributes and factors that cannot be 
                integrated readily in a benefit-cost framework, such as 
                fairness and privacy. However, effective regulation is 
                the result of the careful use of all available high-
                quality data, and the application of broad principles 
                established by the President.

[[Page 64086]]

                In pursuing this goal of establishing an effective, 
                results-oriented regulatory system, the Bush 
                Administration has increased the level of public 
                involvement and transparency in its review and 
                clearance of new and existing regulations.

                For new rulemakings and programs, OIRA has enhanced the 
                transparency of OMB's regulatory review process. OIRA's 
                website now enables the public to find which rules are 
                formally under review at OMB and which rules have 
                recently been cleared or have been returned to agencies 
                for reconsideration. OIRA has also increased the amount 
                of information available on its website. In addition to 
                information on meetings and correspondence, OIRA makes 
                available communications from the OIRA Administrator to 
                agencies, including ``prompt letters,'' ``return 
                letters,'' and ``post clearance letters,'' as well as 
                the Administrator's memorandum to the President's 
                Management Council (September 20, 2001) on presidential 
                review of agency rulemaking by OIRA.

                For existing rulemakings, OIRA has initiated a modest 
                series of calls for reform nominations in 2001, 2002, 
                and 2004. In the draft 2001 annual Report to Congress 
                on the Costs and Benefits of Federal Regulation, OMB 
                asked for suggestions from the public about specific 
                regulations that should be modified in order to 
                increase net benefits to the public. We received 
                suggestions regarding 71 regulations, 23 of which OMB 
                designated as high priorities. After a similar call for 
                reforms in the 2002 draft Report, OMB received 
                recommendations on 316 distinct rules, guidance 
                documents, and paperwork requirements from over 1,700 
                commenters. Of the 156 reform nominations that OMB 
                determined were ripe for consideration by Cabinet-level 
                agencies and the Environmental Protection Agency, 
                agencies decided to pursue 34 rules and 11 guidance 
                documents for reform. Finally, in the 2004 draft 
                Report, OMB requested public nominations of promising 
                regulatory reforms relevant to the manufacturing 
                sector. In particular, commenters were asked to suggest 
                specific reforms to rules, guidance documents, or 
                paperwork requirements that would improve manufacturing 
                regulation by reducing unnecessary costs, increasing 
                effectiveness, enhancing competitiveness, reducing 
                uncertainty, and increasing flexibility. In response to 
                the solicitation, OMB received 189 distinct reform 
                nominations from 41 commenters. Of these, Federal 
                agencies and OMB have determined that 76 of the 189 
                nominations have potential merit and justify further 
                action. For further information, all of these Reports 
                are available on OIRA's website at http://
www.whitehouse.gov/omb/inforeg/regpol.html.

                The Bush Administration has also moved aggressively to 
                establish basic quality performance goals for all 
                information disseminated by Federal agencies, including 
                information disseminated in support of proposed and 
                final regulations. The Federal agencies issued 
                guidelines on October 1, 2002 under the Information 
                Quality Act to ensure the ``quality, objectivity, 
                utility, and integrity'' of all information 
                disseminated by Federal agencies. Under these 
                guidelines, Federal agencies are taking appropriate 
                steps to incorporate the information quality 
                performance standards into agency information 
                dissemination practices, and developing pre-
                dissemination review procedures to substantiate the 
                quality of information before it is disseminated. Under 
                the agency information quality guidelines, ``affected 
                persons'' can request that the agencies correct 
                information if they believe that scientific, technical, 
                economic, statistical or other information disseminated 
                does not meet the agency and OMB standards. If the 
                requestor is dissatisfied with the initial agency 
                response to a correction request, an appeal opportunity 
                is provided by the agencies. Although we are still in 
                the early phases of implementation, agencies are aware 
                that ensuring the high quality of government 
                information disseminations is a high priority of the 
                Administration. Further information on OIRA's 
                activities implementing the Information Quality Act is 
                available on OIRA's website at http://
www.whitehouse.gov/omb/inforeg/infopoltech.html.

[[Page 64087]]

                As part of its efforts to improve the quality, 
                objectivity, utility, and integrity of information 
                disseminated by the Federal agencies, on December 16, 
                2004, OMB issued a Final Information Quality Bulletin 
                for Peer Review. This Bulletin establishes 
                Governmentwide guidance aimed at enhancing the practice 
                of peer review of government science documents.

                The Bulletin describes minimum standards for when peer 
                review is required and how intensive the peer review 
                should be for different information. The Bulletin 
                requires the most rigorous form of peer review for 
                highly influential scientific assessments. Further 
                information on peer review is available on OIRA's 
                website at http://www.whitehouse.gov/omb/memoranda/
fy2005/m05-03.pdf.

                In addition, the Administration is currently increasing 
                the impact of OMB's analytical perspective. The OIRA 
                Administrator is using the ``prompt letter'' to 
                agencies as a new way to suggest promising regulatory 
                priorities and highlight issues that may warrant 
                regulatory attention. Though not meant to have legal 
                authority, these prompt letters are designed to bring 
                issues to the attention of agencies in a transparent 
                manner that permits public scrutiny and debate. Prompt 
                letters may highlight regulations that should be 
                pursued, rescinded, revised, or further investigated. 
                For example, OIRA's first set of prompts suggested 
                lifesaving opportunities at FDA, NHTSA, OSHA and EPA. 
                In a letter to FDA, OIRA suggested that priority be 
                given to completing a promising rulemaking (started in 
                the previous Administration), to require that food 
                labels report the trans-fatty acid content of foods. 
                (Trans-fats are now recognized as a significant 
                contributor to coronary heart disease.) FDA has issued 
                a final rule that will require the disclosure of trans-
                fat content in food labels. Similarly, OSHA has 
                responded to an OIRA prompt letter by notifying each 
                employer in the country of the lifesaving effects and 
                cost-effectiveness of automatic defibrillators, a 
                lifesaving technology designed to save lives during 
                sudden cardiac arrest. A list of all of the prompt 
                letters is available at OIRA's website at http://
www.whitehouse.gov/omb/inforeg/prompt--letter.html.

                In addition to increasing the level of public 
                involvement and transparency in its review of 
                regulations, the Bush Administration has sought to 
                enhance the role of analysis in the development of 
                effective regulations. On September 17, 2003, OMB 
                issued revised guidance to agencies on regulatory 
                analysis.\1\ Key features of the revised guidance 
                include more emphasis on cost-effectiveness, more 
                careful evaluation of qualitative and intangible 
                values, and a greater emphasis on considering the 
                uncertainty inherent in estimates of impact. OIRA was 
                very interested in updating the guidance in light of 
                these and other innovations now commonplace in the 
                research community. The 2005 Regulatory Plan continues 
                OIRA's effort to ensure coordination across Federal 
                agencies in pursuing analytically sound regulatory 
                policies.

                The Administration's 2005 Regulatory Priorities

                With regard to Federal regulation, the Bush 
                Administration's objective is quality, not quantity. 
                Those rules that are adopted promise to be more 
                effective, less intrusive, and more cost-effective in 
                achieving national objectives while demonstrating 
                greater durability in the face of political and legal 
                attack. The Regulatory Plan is integral to enhancing 
                the quality of Federal regulations, and OMB seeks to 
                ensure that the public is provided with the information 
                needed to understand and comment on the Federal

                ------------

                \1\ See Circular A-4, ``Regulatory Analysis,'' 
                published as part of OMB's 2003 Report to Congress on 
                the Costs and Benefits of Federal Regulations. The 
                report is available on OMB's website at http://
www.whitehouse.gov/omb/inforeg/2003--cost-ben--final--
rpt.pdf

[[Page 64088]]

                regulatory agenda. Accordingly, the 2005 Regulatory 
                Plan highlights the following themes:

                         Regulations that are particularly good 
                            examples of the Administration's ``smart'' 
                            regulation agenda to streamline regulations 
                            and reporting requirements, which is a key 
                            part of the President's economic plan.

                         Regulations that are of particular 
                            concern to small businesses.

                         Regulations that respond to public 
                            nominations submitted to OMB in 2001 or 
                            2002.

                         Regulations that address 2004 
                            nominations for promising regulatory 
                            reforms in the manufacturing sector.

                Conclusion

                Smarter regulatory policies, created through public 
                participation, transparency, and cooperation across 
                Federal agencies, are a key Administration objective. 
                The following department and agency plans provide 
                further information on regulatory priorities. All 
                agencies' plans are a reflection of the 
                Administration's Federal Regulatory Policy objectives, 
                which aim at implementing an effective and results-
                oriented regulatory system.

[[Page 64089]]


                                                                DEPARTMENT OF AGRICULTURE
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
1                National Organic Program: Harvey v. Johanns                                                                 0581-AC54    Proposed Rule
                                                                                                                                                  Stage
2                Mandatory Country of Origin Labeling of Beef, Pork, Lamb, Fish, Perishable Agricultural                     0581-AC26 Final Rule Stage
                 Commodities, and Peanuts (LS-03-04)
3                California Clingstone Peach Diversion Program (Tree Pull), FV05-82-01                                       0581-AC45 Final Rule Stage
4                Tuberculosis in Cattle; Import Requirements                                                              0579-AB44       Proposed Rule
                                                                                                                                                  Stage
5                Animal Welfare; Regulations and Standards for Birds, Rats, and Mice                                      0579-AB69       Proposed Rule
                                                                                                                                                  Stage
6                Revision of Fruits and Vegetables Import Regulations                                                     0579-AB80       Proposed Rule
                                                                                                                                                  Stage
7                Revision of the Nursery Stock Regulations                                                                0579-AB85       Proposed Rule
                                                                                                                                                  Stage
8                Importation of Boneless Beef from Japan                                                                  0579-AB93       Proposed Rule
                                                                                                                                                  Stage
9                Importation of Small Lots of Seed Without Phytosanitary Certificates                                     0579-AB78    Final Rule Stage
10               Phytophthora Ramorum; Quarantine and Regulations                                                         0579-AB82    Final Rule Stage
11               FSP: Discretionary Quality Control Provisions of Title IV of Public Law 107-171                          0584-AD37       Proposed Rule
                                                                                                                                                  Stage
12               Special Nutrition Programs: Fluid Milk Substitutions                                                     0584-AD58       Proposed Rule
                                                                                                                                                  Stage
13               Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC       0584-AD77       Proposed Rule
                 Food Packages                                                                                                                    Stage
14               FSP: Eligibility and Certification Provisions of the Farm Security and Rural Investment Act of 2002      0584-AD30    Final Rule Stage
15               FSP: Non-Discretionary Quality Control Provisions of Title IV of Public Law 107-171                      0584-AD31    Final Rule Stage
16               FSP: Employment and Training Program Provisions of the Farm Security and Rural Investment Act of         0584-AD32    Final Rule Stage
                 2002
17               Categorical Eligibility and Direct Certification for Free and Reduced Price Meals and Free Milk in       0584-AD60    Final Rule Stage
                 Schools
18               Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): WIC Vendor Cost           0584-AD71    Final Rule Stage
                 Containment
19               Performance Standards for Pumped or Massaged Bacon                                                          0583-AC49    Proposed Rule
                                                                                                                                                  Stage
20               Egg Products Inspection Regulations                                                                         0583-AC58    Proposed Rule
                                                                                                                                                  Stage
21               Performance Standard for Chilling of Ready-To-Cook Poultry                                                  0583-AC87    Proposed Rule
                                                                                                                                                  Stage
22               Sharing of Firms' Distribution Lists of Retail Consignees During Meat or Poultry Product Recalls         0583-AD10       Proposed Rule
                                                                                                                                                  Stage
23               Performance Standards for the Production of Processed Meat and Poultry Products                             0583-AC46 Final Rule Stage
24               Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products            0583-AC60 Final Rule Stage
25               Food Standards; General Principles and Food Standards Modernization                                         0583-AC72 Final Rule Stage
26               Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the                  0583-AC88 Final Rule Stage
                 Disposition of Non-Ambulatory Disabled Cattle
27               Travel Management (Proposed Directives, Forest Service Manual 2300 and 7700)                                0596-AC39    Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                 DEPARTMENT OF COMMERCE
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
28               Northwest Hawaiian Islands National Marine Sanctuary; Designation and Implementation of Regulations      0648-AS83       Proposed Rule
                                                                                                                                                  Stage
29               Fisheries of the United States; National Standard 1                                                      0648-AQ63    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 64090]]


                                                                 DEPARTMENT OF EDUCATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
30               Assistance to States for the Education of Children With Disabilities; Preschool Grants for Children      1820-AB57    Final Rule Stage
                 With Disabilities; and Service Obligations Under Special Education--Personnel Development
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                                  DEPARTMENT OF ENERGY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
31               Rulemaking To Determine Whether the Energy Conservation Standards for Residential Central Air            1904-AB47       Prerule Stage
                 Conditioners and Air Conditioning Heat Pumps Should Be Amended
32               Rulemaking To Determine Whether the Energy Conservation Standards for Residential Water Heaters          1904-AB48       Prerule Stage
                 Should Be Amended
33               Rulemaking To Determine Whether the Energy Conservation Standards for Electric and Gas Ranges and        1904-AB49       Prerule Stage
                 Ovens, and for Microwave Ovens Should Be Amended
34               Rulemaking To Determine Whether the Energy Conservation Standards for Fluorescent Lamp Ballasts          1904-AB50       Prerule Stage
                 Should Be Amended
35               Rulemaking To Determine Whether the Energy Conservation Standards for Room Air Conditioners Should       1904-AB51       Prerule Stage
                 Be Amended
36               Energy Efficiency Standards for Residential Furnaces and Boilers                                         1904-AA78       Proposed Rule
                                                                                                                                                  Stage
37               Energy Efficiency Standards for Electric Distribution Transformers                                       1904-AB08       Proposed Rule
                                                                                                                                                  Stage
38               Acquisition of Petroleum for Strategic Petroleum Reserve                                                 1901-AB16       Proposed Rule
                                                                                                                                                  Stage
39               Radiation Protection of the Public and the Environment                                                   1901-AA38    Final Rule Stage
40               Worker Safety and Health                                                                                 1901-AA99    Final Rule Stage
41               Standby Support for Advanced Nuclear Facility Delays                                                     1901-AB17    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                         DEPARTMENT OF HEALTH AND HUMAN SERVICES
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
42               Control of Communicable Diseases, Interstate and Foreign Quarantine                                      0920-AA12       Proposed Rule
                                                                                                                                                  Stage
43               Foreign and Domestic Establishment Registration and Listing Requirements for Human Drugs, Including      0910-AA49       Proposed Rule
                 Drugs that are Regulated Under a Biologics License Application, and Animal Drugs                                                 Stage
44               Submission of Standardized Electronic Study Data From Clinical Studies Evaluating Human Drugs and           0910-AC52    Proposed Rule
                 Biologics                                                                                                                        Stage
45               Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for              0910-AF11       Proposed Rule
                 Pregnancy and Lactation Labeling                                                                                                 Stage
46               Expanded Access to Investigational Drugs for Treatment Use                                               0910-AF14       Proposed Rule
                                                                                                                                                  Stage
47               Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products      0910-AA94    Final Rule Stage
48               Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and        0910-AB88    Final Rule Stage
                 Dietary Supplements
49               Toll-Free Number for Reporting Adverse Events on Labeling for Human Drugs                                   0910-AC35 Final Rule Stage
50               Innovations in Fee-for-Service Payment Systems to Improve Quality and Outcomes (CMS-1298-ANPR)           0938-AN91       Prerule Stage
51               Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics, Orthotics, and         0938-AN14       Proposed Rule
                 Supplies and Residual Issues (CMS-1270-P)                                                                                        Stage

[[Page 64091]]

 
52               Changes to the Hospital Inpatient Prospective Payment Systems and FY 2007 Rates (CMS-1488-P)             0938-AO12       Proposed Rule
                                                                                                                                                  Stage
53               Organ Procurement Organization Conditions for Coverage (CMS-3064-IFR)                                    0938-AK81    Final Rule Stage
54               Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006 Payment Rates       0938-AN46    Final Rule Stage
                 (CMS-1501-FC)
55               Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006 (CMS-1502-FC)      0938-AN84    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             DEPARTMENT OF HOMELAND SECURITY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
56               Procedures for Handling Critical Infrastructure Information                                              1601-AA14    Final Rule Stage
57               Regulations Implementing the Support Antiterrorism by Fostering Effective Technologies Act of 2002       1601-AA15    Final Rule Stage
                 (the SAFETY Act)
58               Protection of Human Subjects                                                                             1601-AA29    Final Rule Stage
59               Marine Casualties and Investigations; Chemical Testing Following Serious Marine Incidents (USCG-         1625-AA27    Final Rule Stage
                 2001-8773)
60               Validation of Merchant Mariners' Vital Information and Issuance of Coast Guard Merchant Mariner's        1625-AA85    Final Rule Stage
                 Licenses and Certificates of Registry (USCG-2004-17455)
61               Vessel Requirements for Notices of Arrival and Departure, and Carriage of Automatic Identification       1625-AA99    Final Rule Stage
                 System (USCG-2005-21869)
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                       DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
62               Amendments to HUD's Environmental Regulations (FR-4954)                                                  2501-AD11       Proposed Rule
                                                                                                                                                  Stage
63               Disposition of HUD-Acquired Single Family Property Amendments (FR-4952)                                  2502-AI27       Proposed Rule
                                                                                                                                                  Stage
64               Housing Opportunities for Persons With AIDS (HOPWA) (FR-4708)                                               2506-AC11    Proposed Rule
                                                                                                                                                  Stage
65               GNMA: Excess Yield Securities (FR-4958)                                                                  2503-AA18       Proposed Rule
                                                                                                                                                  Stage
66               Streamlining Public Housing Programs (FR-4990)                                                              2577-AC59    Proposed Rule
                                                                                                                                                  Stage
67               Housing Choice Voucher Program Homeownership Option; Eligibility of Units Not Yet Under                     2577-AC60    Proposed Rule
                 Construction (FR-4991)                                                                                                           Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                               DEPARTMENT OF THE INTERIOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
68               Valuation of Oil From Indian Leases                                                                      1010-AD00       Proposed Rule
                                                                                                                                                  Stage
69               Relief or Reduction in Royalty Rates - New Deep Gas and Offshore Alaska Provisions                       1010-AD31       Proposed Rule
                                                                                                                                                  Stage
70               Placement of Excess Spoil                                                                                   1029-AC04    Proposed Rule
                                                                                                                                                  Stage
71               Grazing Administration--Exclusive of Alaska                                                              1004-AD42    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 64092]]


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


                                                                   DEPARTMENT OF LABOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
74               Family and Medical Leave Act of 1993; Conform to the Supreme Court's Ragsdale Decision                   1215-AB35       Proposed Rule
                                                                                                                                                  Stage
75               Revision to the Department of Labor Benefit Regulations for Trade Adjustment Assistance for Workers      1205-AB32       Proposed Rule
                 Under the Trade Act of 1974, as Amended                                                                                          Stage
76               Revision to the Department of Labor Regulations for Petitions and Determinations of Eligibility To       1205-AB40       Proposed Rule
                 Apply for Trade Adjustment Assistance for Workers and Issuance of Regulations for the Alternative                                Stage
                 TAA
77               Amendment of Regulation Relating to Definition of Plan Assets--Participant Contributions                 1210-AB02       Proposed Rule
                                                                                                                                                  Stage
78               Amendment of Section 404(c) Regulation Default Investments                                               1210-AB10       Proposed Rule
                                                                                                                                                  Stage
79               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
80               Prohibiting Discrimination Against Participants and Beneficiaries Based on Health Status                 1210-AA77    Final Rule Stage
81               Rulemaking Relating to Termination of Abandoned Individual Account Plans                                 1210-AA97    Final Rule Stage
82               Asbestos Exposure Limit                                                                                  1219-AB24    Final Rule Stage
83               Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners                              1219-AB29    Final Rule Stage
84               Occupational Exposure to Crystalline Silica                                                              1218-AB70       Prerule Stage
85               Assigned Protection Factors: Amendments to the Final Rule on Respiratory Protection                      1218-AA05    Final Rule Stage
86               Occupational Exposure to Hexavalent Chromium (Preventing Occupational Illness: Chromium)                 1218-AB45    Final Rule Stage
87               Uniformed Services Employment and Reemployment Rights Act Regulations                                    1293-AA09    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                              DEPARTMENT OF TRANSPORTATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
88               Aging Aircraft Program (Widespread Fatigue Damage)                                                       2120-AI05       Proposed Rule
                                                                                                                                                  Stage
89               Transport Airplane Fuel Tank Flammability Reduction                                                      2120-AI23       Proposed Rule
                                                                                                                                                  Stage
90               Enhanced Airworthiness Program for Airplane Systems (EAPAS) and SFAR 88                                  2120-AI31       Proposed Rule
                                                                                                                                                  Stage
91               Aging Aircraft Safety--Development of TC and STC Holder Data                                             2120-AI32       Proposed Rule
                                                                                                                                                  Stage
92               Medical Certification Requirements as Part of the CDL                                                    2126-AA10       Proposed Rule
                                                                                                                                                  Stage
93               Unified Registration System                                                                              2126-AA22    Final Rule Stage
94               Reduced Stopping Distance Requirements for Truck Tractors                                                2127-AJ37       Proposed Rule
                                                                                                                                                  Stage
95               Light Truck Average Fuel Economy Standards, Model Year 2008 and Possibly Beyond                          2127-AJ61       Proposed Rule
                                                                                                                                                  Stage
96               5th Percentile Dummy Belted Barrier Crash Test Requirements -- Standard 208                              2127-AI98    Final Rule Stage
97               Side Impact Protection Upgrade - FMVSS No. 214                                                           2127-AJ10    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 64093]]


                                                               DEPARTMENT OF THE TREASURY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
98               Implementation of a Revised Basel Capital Accord (Basel II)                                                 1557-AC91    Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             DEPARTMENT OF VETERANS AFFAIRS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
99               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                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
100              Review of the National Ambient Air Quality Standards for Particulate Matter                              2060-AI44       Proposed Rule
                                                                                                                                                  Stage
101              Control of Hazardous Air Pollutants From Mobile Sources                                                  2060-AK70       Proposed Rule
                                                                                                                                                  Stage
102              Clean Air Fine Particle Implementation Rule                                                              2060-AK74       Proposed Rule
                                                                                                                                                  Stage
103              Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Allowables      2060-AL75       Proposed Rule
                 Plantwide Applicability Limit (PAL), Aggregation, and Debottlenecking                                                            Stage
104              Control of Emissions From New Locomotives and New Marine Diesel Engines Less Than 30 Liters Per          2060-AM06       Proposed Rule
                 Cylinder                                                                                                                         Stage
105              Control of Emissions from Spark-Ignition Engines and Fuel Systems from Marine Vessels and Small          2060-AM34       Proposed Rule
                 Equipment                                                                                                                        Stage
106              Implementing Periodic Monitoring in Federal and State Operating Permit Programs                          2060-AN00       Proposed Rule
                                                                                                                                                  Stage
107              Fuel Economy Labeling of Motor Vehicles: Revisions to Improve Calculation of Fuel Economy Estimates      2060-AN14       Proposed Rule
                                                                                                                                                  Stage
108              Amendment of the Standards for Radioactive Waste Disposal in Yucca Mountain, Nevada                      2060-AN15       Proposed Rule
                                                                                                                                                  Stage
109              Review of the National Ambient Air Quality Standards for Ozone                                           2060-AN24       Proposed Rule
                                                                                                                                                  Stage
110              Prevention of Significant Deterioration and Nonattainment New Source Review: Alternative                 2060-AN28       Proposed Rule
                 Applicability Test for Electric Generating Units                                                                                 Stage
111              Renewable Fuel Standards Requirements for 2006                                                           2060-AN51       Proposed Rule
                                                                                                                                                  Stage
112              Lead-Based Paint Activities; Amendments for Renovation, Repair and Painting                                 2070-AC83    Proposed Rule
                                                                                                                                                  Stage
113              Notification of Chemical Exports Under TSCA Section 12(b)                                                2070-AJ01       Proposed Rule
                                                                                                                                                  Stage
114              Administrative Reporting Exemption for Certain Air Releases of NOx                                       2050-AF02       Proposed Rule
                                                                                                                                                  Stage
115              Revisions to the Spill Prevention, Control, and Countermeasure (SPCC) Rule, 40 CFR Part 112              2050-AG16       Proposed Rule
                                                                                                                                                  Stage
116              Regulatory Actions Associated with the Notices of Data Availability on the Spill Prevention,             2050-AG23       Proposed Rule
                 Control, and Countermeasure (SPCC) Rule, 40 CFR Part 112                                                                         Stage
117              Expanding the Comparable Fuels Exclusion Under RCRA                                                      2050-AG24       Proposed Rule
                                                                                                                                                  Stage

[[Page 64094]]

 
118              Toxics Release Inventory Reporting Burden Reduction Rule                                                 2025-AA14       Proposed Rule
                                                                                                                                                  Stage
119              Inclusion of Delaware and New Jersey in the Clean Air Interstate Rule                                    2060-AM95    Final Rule Stage
120              Rule on Section 126 Petition from NC to Reduce Interstate Transport of Fine PM and O3; FIPs to           2060-AM99    Final Rule Stage
                 Reduce Interstate Transport of Fine PM & O3; Revisions to CAIR Rule; Revisions to Acid Rain Program
121              Regional Haze Regulations; Revisions to Provisions Governing Alternative to Source-Specific Best         2060-AN22    Final Rule Stage
                 Available Retrofit Technology (BART) Determinations
122              Implementation Rule for 8-Hour Ozone NAAQS - Phase 2                                                     2060-AN23    Final Rule Stage
123              Test Rule; Testing of Certain High Production Volume (HPV) Chemicals                                     2070-AD16    Final Rule Stage
124              Pesticides; Procedures for the Registration Review Program                                               2070-AD29    Final Rule Stage
125              Pesticides; Emergency Exemption Process Revisions                                                        2070-AD36    Final Rule Stage
126              Protections for Test Subjects in Human Research                                                          2070-AD57    Final Rule Stage
127              RCRA Burden Reduction Initiative                                                                         2050-AE50    Final Rule Stage
128              Revisions to the Definition of Solid Waste                                                               2050-AE98    Final Rule Stage
129              National Primary Drinking Water Regulations: Ground Water Rule                                           2040-AA97    Final Rule Stage
130              National Primary Drinking Water Regulations: Long Term 2 Enhanced Surface Water Treatment Rule           2040-AD37    Final Rule Stage
131              National Primary Drinking Water Regulations: Stage 2 Disinfection Byproducts Rule                        2040-AD38    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


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


                                                      NATIONAL ARCHIVES AND RECORDS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
133              Federal Records Management                                                                               3095-AB16       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


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


                                                              SMALL BUSINESS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
135              Small Business Lending Company and Lender Oversight Regulations                                          3245-AE14       Proposed Rule
                                                                                                                                                  Stage
136              Small Business Technology Transfer Program Policy Directive                                              3245-AE96    Final Rule Stage
137              Small Business Innovation Research (SBIR) Policy Directive                                               3245-AF21    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 64095]]


                                                             SOCIAL SECURITY ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
138              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
139              Exemption of Work Activity as a Basis for a Continuing Disability Review (Ticket to Work and Work        0960-AE93       Proposed Rule
                 Incentives Improvement Act of 1999) (725P)                                                                                       Stage
140              Revised Medical Criteria for Evaluating Immune System Disorders (804P)                                   0960-AF33       Proposed Rule
                                                                                                                                                  Stage
141              Revised Medical Criteria for Evaluating Mental Disorders (886P)                                          0960-AF69       Proposed Rule
                                                                                                                                                  Stage
142              Amendments to the Ticket to Work and Self-Sufficiency Program (967P)                                     0960-AF89       Proposed Rule
                                                                                                                                                  Stage
143              Representative Payment; Policies and Administrative Procedure for Imposing Penalties for False or        0960-AG09       Proposed Rule
                 Misleading Statements or Withholding of Information (2422P)                                                                      Stage
144              Issuance of Work Report Receipts, Payment of TWP Months After a Fraud Conviction, Changes to the         0960-AG10       Proposed Rule
                 SEIE, & Expansion of the Reentitlement Period for Childhood DIB Benefits (2502P)                                                 Stage
145              Medicare Part B Income-Related Monthly Adjustment Amount (2101P)                                         0960-AG11       Proposed Rule
                                                                                                                                                  Stage
146              Nonpayment of Benefits to Fugitive Felons and Probation or Parole Violators (2222P)                      0960-AG12       Proposed Rule
                                                                                                                                                  Stage
147              Changes to the Income and Resources Provisions for SSI Based on Sections 430, 435, and 436 of the        0960-AG13       Proposed Rule
                 Social Security Protection Act (SSPA) of 2004 (2482P)                                                                            Stage
148              Continuing Disability Review Failure To Cooperate Process (2763P)                                        0960-AG19       Proposed Rule
                                                                                                                                                  Stage
149              Prohibition of Entitlement on Earnings Records for Certain Alien Workers (2882P)                         0960-AG22       Proposed Rule
                                                                                                                                                  Stage
150              Limiting Replacement of Social Security Number Cards (965P)                                              0960-AG25       Proposed Rule
                                                                                                                                                  Stage
151              Age as a Factor in Evaluating Disability (3183P)                                                         0960-AG29       Proposed Rule
                                                                                                                                                  Stage
152              Administrative Review Process for Adjudicating Initial Disability Claims (3203F)                         0960-AG31       Proposed Rule
                                                                                                                                                  Stage
153              Evidentiary Requirements for Making Findings About Medical Equivalence (787F)                            0960-AF19    Final Rule Stage
154              Revised Medical Criteria for Evaluating Impairments of the Digestive System (800F)                       0960-AF28    Final Rule Stage
155              Revised Medical Criteria for Evaluating Cardiovascular Disorders (826F)                                  0960-AF48    Final Rule Stage
156              Rules for Helping Blind and Disabled Individuals Achieve Self-Support (506F)                             0960-AG00    Final Rule Stage
157              Medicare Part D Subsidies (1024F)                                                                        0960-AG03    Final Rule Stage
158              Civil Monetary Penalties, Assessments, and Recommended Exclusions (2362F)                                0960-AG08    Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                           CONSUMER PRODUCT SAFETY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
159              Flammability Standard for Upholstered Furniture                                                          3041-AB35       Proposed Rule
                                                                                                                                                  Stage
160              Proposed Standard To Address Open-Flame Ignition of Mattresses/Foundation Sets                              3041-AC02 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                            NATIONAL INDIAN GAMING COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Regulation
   Sequence                                                     Title                                                   Identifier     Rulemaking Stage
    Number                                                                                                                Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
161              Technical Amendments to the Minimum Internal Control Standards                                           3141-AA27       Proposed Rule
                                                                                                                                                  Stage

[[Page 64096]]

 
162              Technical Standards for Gaming Machines and Gaming Systems                                               3141-AA29       Proposed Rule
                                                                                                                                                  Stage
163              Game Classification Standards                                                                            3141-AA31       Proposed Rule
                                                                                                                                                  Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------


[FR Doc. 05-21048 Filed 10-28-05; 8:45 am]
BILLING CODE 6820-27-S

[[Page 64097]]




DEPARTMENT OF AGRICULTURE (USDA)



Statement of Regulatory Priorities
 USDA is a primary issuer of regulations within the Federal Government 
covering a broad range of issues. Within the rulemaking process is the 
department-wide effort to reduce burden on participants and program 
administrators alike by focusing on improving program outcomes, and 
particularly on achieving the performance measures specified in the 
USDA and agency Strategic Plans. Significant focus is being placed on 
efficiencies that can be achieved through eGov activities, the 
migration to efficient electronic services and capabilities, and the 
implementation of focused, efficient information collections necessary 
to support effective program management. Important areas of activity 
include the following:
 USDA will develop new regulations and review existing 
            regulations to prevent the introduction or spread of pests 
            and diseases into the United States. In addition, it will 
            continue to work to minimize impediments to trade while 
            protecting U.S. animal and plant resources.
 In the area of food safety, USDA will continue to develop 
            science-based regulations that improve the safety of meat, 
            poultry, and egg products in the least burdensome and most 
            cost-effective manner. Regulations will be revised to 
            address emerging food safety challenges, streamlined to 
            remove excessively prescriptive regulations, and updated to 
            be made consistent with hazard analysis and critical 
            control point principles.
 As changes are made for the nutrition assistance programs, 
            USDA will work to foster actions that will help improve 
            diets, and particularly to prevent and reduce overweight 
            and obesity. In 2006, this will include implementing 
            refinements to the nutrition assistance programs included 
            in reauthorization statutes as well as additional changes 
            that will promote healthful eating and physical activity, 
            while also improving the efficiency and integrity of 
            program operations.
 USDA will finalize rulemaking for the Conservation Security 
            Program (CSP). The program was implemented under an interim 
            final rule in 2004. An amendment to the interim final rule 
            was published in March 2005 and the Department is now 
            making clarifications and modifications in response to the 
            comments received.
Reducing Paperwork Burden on Customers
 USDA 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 USDA are providing 
electronic alternatives to their traditionally paper-based customer 
transactions. As a result, producers increasingly have the option to 
electronically file forms and all other documentation online. To 
facilitate the expansion of electronic government and promote 
compliance with GPEA, USDA implemented an electronic authentication 
capability that allows customers to ``sign-on'' once and conduct 
business with all USDA agencies. Underlying these efforts are ongoing 
analyses to identify and eliminate redundant data collections and 
streamline collection instructions. The end result of implementing 
these initiatives is better service to our customers enabling them to 
choose when and where to conduct business with USDA.
The Role of Regulations
 The programs of USDA are diverse and far reaching, as are the 
regulations that attend their delivery. Regulations codify how USDA 
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 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 USDA programs has accompanying 
regulatory needs, often with a significant impact. The Farm Security 
and Rural Investment Act of 2002, Public Law 107-171; the Child 
Nutrition and WIC Reauthorization Act of 2004, Public Law 108-265; and 
the Agricultural Risk Protection Act of 2000, Public Law 106-224, 
affect most agencies of USDA resulting in the modification, addition, 
or deletion of many programs. These statutes set in motion rulemakings 
that provide for improvements in market loss and conservation 
assistance, crop and livestock disease and pest protection, marketing 
enhancements, pollution control, research and development for biomass, 
and refinements to the nutrition assistance programs to help ensure the 
best practical outcomes for beneficiaries and the taxpayer.
Major Regulatory Priorities
 This document represents summary information on prospective 
significant regulations as called for in Executive Order 12866. The 
following agencies are represented in this regulatory plan, along with 
a summary of their mission and key regulatory priorities for 2006:
Food and Nutrition Service
 Mission: FNS increases food security and reduces hunger in partnership 
with cooperating organizations by providing children and low-income 
people access to food, a healthful diet, and nutrition education in a 
manner that supports American agriculture and inspires public 
confidence.
Priorities: In addition to responding to provisions of legislation 
authorizing and modifying Federal nutrition assistance programs, FNS's 
2005 regulatory plan supports the broad goals and objectives in the 
Agency's strategic plan, including:
Improved nutrition of children and low-income people. This goal 
represents FNS's efforts to improve nutrition by providing access to 
program benefits (Food Stamps, WIC food vouchers and nutrition 
services, school meals, commodities and State administrative funds), 
nutrition education, and quality

[[Page 64098]]

meals and other benefits. It includes three major objectives: 1) 
improved food security, which reflects nutrition assistance benefits 
issued to program participants; 2) FNS program participants making 
healthy food choices, which represents our efforts to improve nutrition 
knowledge and behavior through nutrition education and breastfeeding 
promotion; and 3) improved nutritional quality of meals, food packages, 
commodities, and other program benefits, which represents our efforts 
to ensure that program benefits meet the appropriate nutrition 
standards to effectively improve nutrition for program participants.
 In support of this goal, FNS plans to finalize rules implementing 
provisions of the Farm Security and Rural Investment Act of 2002 (P.L. 
107-171), as well as under other authorities, to simplify program 
administration, support work, and improve access to benefits in the 
Food Stamp Program. FNS will also publish rules implementing provisions 
of the Child Nutrition and WIC Reauthorization Act of 2004 (P.L. 108-
265) to ensure access to the Child Nutrition Programs for low-income 
children receiving Temporary Assistance for Needy Families through 
direct certification for homeless children, and to revise requirements 
allowing schools to substitute nutritionally-equivalent non-dairy 
beverages for fluid milk at the request of a recipient's parent. 
Finally, FNS will propose rule changes to improve food packages in the 
WIC program to reflect current dietary guidance, based on 
recommendations made by an Institute of Medicine expert panel.
Improved Stewardship of Federal Funds. This goal represents FNS's 
ongoing commitment to maximize the accuracy of benefits issued, 
maximize the efficiency and effectiveness of program operations, and 
minimize participant and vendor fraud. It includes two major 
objectives: 1) improved benefit accuracy and reduced fraud, which 
represents the agency's effort to reduce participant and agency errors, 
and to control Food Stamp and WIC trafficking and participant, vendor, 
and administrative agency fraud; and 2) improved efficiency of program 
administration, which represents our efforts to streamline program 
operations and improve program structures as necessary to maximize 
their effectiveness.
 In support of this goal, FNS plans to finalize rules implementing 
provisions of P.L. 107-171 to modify the system of sanctions and 
incentives used to minimize certification errors in the Food Stamp 
Program, and to finalize rules that will simplify funding for the Food 
Stamp Employment and Training Program. FNS will also publish rules to 
improve management of retail food vendors in the WIC Program and to 
improve accountability and performance measurement in the Commodity 
Supplemental Food 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 preparing regulatory amendments based on this ongoing 
review, FSIS has published and implemented emergency regulations that 
had been developed under the Agency's proactive, risk-based policy to 
head off 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 
evaluating the effectiveness of the interim rule and is planning 
further action with respect to other elements of the 2001 proposal that 
will be based on quantitative risk assessments of target pathogens in 
processed products.
 In January 2004, FSIS published three interim final rules to prevent 
the agent of bovine spongiform encephalopathy (BSE) from entering the 
human food supply. FSIS took this action in response to the 
confirmation of BSE in a cow in Washington State that had been imported 
from Canada. In addition, FSIS issued a Federal Register Notice in 
January 2004 that announced that the Agency would no longer pass and 
apply the mark of inspection to carcasses and parts of cattle selected 
for BSE testing by APHIS until the sample is determined to be negative. 
In August 2004, FSIS, along with the USDA's Animal and Plant Health 
Inspection Service (APHIS) and the Food and Drug Administration (FDA) 
published a joint Advance Notice of Proposed Rulemaking (ANPRM) that 
describes additional Federal measures that the agencies are considering 
to further mitigate the risk of BSE. FSIS is evaluating the comments 
received in response to the interim final rules and the ANPRM to 
determine whether FSIS should implement additional measures to prevent 
human exposure to the BSE agent.
 FSIS plans to propose amending the poultry products inspection 
regulations by replacing, with a performance standard, 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. Under the performance standard, poultry establishments would 
have to carry out slaughtering, dressing, and chilling operations in a 
manner that ensured no significant growth of pathogens, as demonstrated 
by control of the pathogens or indicator organisms. The existing time/
temperature chilling regulations would remain available for use by 
establishments as a ``safe harbor'' for compliance with the new 
standard.
 FSIS also 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 levels 
of substances that must be used to produce massaged or pumped bacon. 
FSIS will propose to replace these prescriptive

[[Page 64099]]

provisions with an upper limit for nitrite and a performance standard 
that establishments producing massaged or 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.
 Finally, FSIS is proposing to amend the Federal meat and poultry 
products inspection regulations to provide that the Agency would make 
available to individual consumers, in response to requests under the 
Freedom of Information Act, lists of the retail consignees of meat and 
poultry products that have been voluntarily recalled by a federally 
inspected meat or poultry products establishment. FSIS believes that 
this information will be of value to consumers and the industry in 
clarifying which products should be removed from commerce and from 
consumers' possession because the products may be adulterated or 
misbranded.
``Smart'' regulation agenda: The President's smart regulation agenda 
involves modernizing existing rules and adopting new rules only when 
justified by sound science, economics, and law. Examples of FSIS 
rulemakings that support this initiative include the planned 
regulations for pumped bacon and for chilling ready-to-cook poultry. 
These rulemakings are intended to streamline regulations, improve 
regulatory consistency, provide science-based performance standards, 
and offer flexible compliance options to regulated establishments.
 Response to public nominations for regulatory reform: As mentioned, 
FSIS has been evaluating the effectiveness of the interim final rule on 
control of L. monocytogenes in RTE products. Responding to the May 2004 
nomination of the interim final rule as a candidate for regulatory 
reform, FSIS will evaluate the impacts of the rule on small businesses 
and determine what relief or mitigations may be necessary.
 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 conducts an active outreach program assisted by a network of 
State coordinators to help small businesses comply with FSIS 
regulations. The Agency maintains a small business outreach page on its 
Web site with links to sources of technical assistance.
Animal and Plant Health Inspection Service
 Mission: The mission of the Animal and Plant Health Inspection Service 
(APHIS) is to protect the health and value of American agricultural and 
natural resources. APHIS conducts programs to prevent the introduction 
of exotic pests and diseases into the United States and conducts 
surveillance, monitoring, control, and eradication programs for pests 
and diseases in this country. These activities enhance agricultural 
productivity and competitiveness and contribute to the national economy 
and the public health.
Priorities: APHIS continues to work on regulatory initiatives to ensure 
that a comprehensive framework is in place to address the threats posed 
to animal and plant resources. One important animal health initiative 
underway is an update to the State classification standards and 
associated interstate movement requirements contained in the domestic 
bovine tuberculosis regulations and a parallel effort to harmonize the 
regulations regarding the importation of cattle from regions where 
bovine tuberculosis exists with the updated domestic regulations. APHIS 
also continues to work with its State partners and in cooperation with 
industry to develop a national animal identification system. This 
national system is intended to identify specific animals in the United 
States and record their movements over their lifespans, with the goal 
of enabling 48-hour traceback of the movements of any diseased or 
exposed animal. This will help to ensure rapid disease containment and 
maximum protection of America's animals. On the plant side, the Agency 
is considering revisions to its nursery stock regulations to reduce the 
pest risk posed by imported plants, roots, seeds, bulbs, and other 
propagative materials, and will continue to update the regulations 
pertaining to Sudden Oak Death as more becomes known about this fungal 
disease. APHIS is also working to revise its regulations for the 
introduction of organisms and products altered or produced through 
genetic engineering to reflect new consolidated authorities under the 
Plant Protection Act.
In addition, recognizing the need to minimize impediments to trade 
while providing necessary protection to animal and plant resources, 
APHIS is developing a proposal to streamline the process for approving 
new fruits and vegetables for importation and, in response to a public 
nomination for regulatory reform, a rule to allow the importation of 
small lots of seed under an import permit with specific conditions, 
instead of requiring a phytosanitary certificate from the government of 
the exporting country. The Agency is also continuing to work on 
amending its regulations concerning bovine spongiform encephalopathy 
(BSE) to provide for the importation of certain animals and products 
that present low risk.
Further, in line with a recent amendment to the definition of 
``animal'' in the Animal Welfare Act, APHIS is considering changes to 
its regulations to promote the humane handling, care, treatment, and 
transportation of birds, rats, and mice not specifically excluded from 
coverage under the Act.
APHIS documents published in the Federal Register and related 
information 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. f ood and fiber products.
Priorities: (1) On August 3, 2005, AMS issued a proposed rule that 
created a voluntary clingstone peach diversion program that would 
consist wholly of tree removal. This action would help the California 
clingstone peach industry address its oversupply problems. The program 
would offer payments to growers who remove a portion of their 
clingstone peach trees from production for a period of 10 years. The 
program would result in the removal of a maximum of 4,000 bearing acres 
of clingstone peach trees. Producers would benefit from this action by 
bringing supply more in line with demand. Furthermore, this action 
would eliminate the need for the Agency to make emergency surplus 
removal

[[Page 64100]]

purchases. The U.S. Department of Agriculture would provide $5 million 
to the program while the industry would contribute $2 million. Comments 
on the proposed rule were due by September 2, 2005.
 (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 
not required in all cases. Thus, consumers desiring to purchase 
products based on country of origin are not fully able to do so. A 
proposed rule was published October 30, 2003, based on interim 
voluntary guidelines also required by the 2002 Farm Bill (that was 
issued on October 8, 2002), and related input from listening sessions 
held throughout the country during 2003. On October 5, 2004, the 
Agricultural Marketing Service published an interim final rule with 
request for comments for the labeling of fish and shellfish covered 
commodities that became effective on April 4, 2005. A final regulatory 
action for all covered commodities will be issued by September 30, 
2006.
 (3) On June 9, 2005, the U.S. District Court for the District of 
Maine, in the case of Harvey v. Johanns (Civil No. 02-216-P-H), issued 
an order finding that, in two instances, the U.S. Department of 
Agriculture exceeded its statutory authority in developing the National 
Organic Program (NOP) regulations. With respect to the use of synthetic 
substances in products labeled as organic (minimum 95% organic content) 
and the exemption of certain dairy animals from organic feed 
requirements, the court directed USDA to conduct notice and comment 
rulemaking not later than 360 days from the date of the Court's order. 
AMS intends to publish a proposed rule by December 31, 2005.
 (4) 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. The NOP on May 25, 2005, convened an 
aquaculture working group to develop draft organic standards for the 
production, handling and labeling of food derived from aquaculture. 
Efforts to convene a similar group to develop draft organic standards 
for the production, handling and labeling of food derived from wild-
harvest fisheries are ongoing. Draft standards developed as a result of 
these groups' work will be forwarded to the NOSB for review and 
consideration as recommendations to the Secretary.
AMS Program Rulemaking Pages: All of AMS's rules that are 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 and scientific exchanges in support of forest and 
range conservation.
Priorities: The Forest Service's priorities for fall 2005 are to 
publish a final regulation revising 36 CFR parts 212, 251, 261, and 
295, regarding travel management on National Forest System (NFS) lands 
to clarify policy related to motor vehicle use; to publish a direct 
final regulation revising 36 CFR parts 251 subpart B, 261 subpart A, 
and 291 that implements the Federal Lands Recreation Enhancement Act 
(REA) (16 U.S.C. 6801-6814); and to publish final directives revising 
Forest Service Manual, Chapters 1330, 1900, and Forest Service Handbook 
1909.12, regarding National Forest System Land Management Planning.
 The final regulation regarding travel management on National Forest 
System lands clarifies policy related to motor vehicle use, including 
the use of off-highway vehicles. This final rule requires Forest 
Service administrative units and ranger districts to designate those 
roads, trails, and areas that are open to motor vehicle use. The final 
rule will prohibit the use of motor vehicles off the designated system, 
as well as use of motor vehicles on routes and in areas that is not 
consistent with the designations. The clear identification of roads, 
trails, and areas for motor vehicle use on each National Forest will 
enhance management of National Forest System lands; sustain natural 
resource values through more effective management of motor vehicle use; 
enhance opportunities for motorized recreation experiences on National 
Forest System lands; address needs for access to National Forest System 
lands; and preserve areas of opportunity in each National Forest for 
nonmotorized travel and experiences. The final rule is consistent with 
provisions of Executive Order 11644 and Executive Order 11989 regarding 
off-road use of motor vehicles on Federal lands. A proposed rule was 
published in the Federal Register on July 15, 2004 (69 FR 42381).
 The Federal Lands Recreation Enhancement Act repealed and supplanted 
section 4 of the Land and Water Conservation Fund Act (16 U.S.C. 4601-
6a) as the authority for special recreation permits issued by federal 
land management agencies and for recreation fees charged by federal 
land management agencies, including the Forest Service. The direct 
final rule adds a definition for recreation fee and revises the 
prohibition for failure to pay recreation fees in 36 CFR part 261, 
subpart A, to conform to the Federal Lands Recreation Enhancement Act.
 The final Land and Resource Management Planning directives to the 
Forest Service Manual 1330 -- New Management Strategies; 1900 -- 
Planning; 1920 -- Land and Resource Management Planning; and Forest 
Service Handbook 1909.12 -- Land and Resource Management Planning 
Handbook provide detailed direction to agency employees necessary to 
implement the provisions in the final planning rule adopted at 36 CFR 
part 219 governing land and resource management planning. The final 
rule was published on January 5, 2005 (70 FR 1023), and the interim 
directives were published on March 23, 2005 (70 FR 14637).

[[Page 64101]]

Natural Resources Conservation Service
 Mission: The Natural Resources Conservation Service (NRCS) mission is 
to provide leadership in a partnership effort to help people conserve, 
maintain, and improve our natural resources and environment.
Priorities: NRCS's priority for FY 2006 will be to make final 
adjustments to a few of the rules related to the conservation 
provisions of the Farm Security and Rural Investment Act of 2002 (the 
2002 Farm Bill), in response to public comments received and experience 
gained from the implementation of the programs. NRCS believes that 
these clarifications and modifications will ensure efficient and 
responsive delivery of conservation programs to landowners and land 
users and help further the agency mission to help people conserve, 
maintain, and improve our natural resources and the environment.
 NRCS remains committed to compliance with the Government Paperwork 
Elimination Act and the Freedom to E-File Act, which require Government 
agencies in general and NRCS in particular to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. NRCS is designing its program forms to 
allow the public to conduct business with NRCS electronically.
The NRCS plans to publish the following rules during FY 2006:
1. Final Rule for the Conservation Security Program (CSP)
2. Amendment to the Final Rule for the Environmental Quality Incentives 
            Program (EQIP)
The rulemakings for CSP and EQIP are minor changes to existing rules.
_______________________________________________________________________



USDA--Agricultural Marketing Service (AMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




1.  NATIONAL ORGANIC PROGRAM: HARVEY V. JOHANNS

Priority:


Other Significant


Legal Authority:


7 USC 6501


CFR Citation:


7 CFR 205


Legal Deadline:


NPRM, Judicial, June 9, 2006.


Abstract:


The Agricultural Marketing Service is revising certain sections of the 
National Organic Program regulations to comply with the final judgment 
in the case of Harvey v. Johanns issued on June 9, 2005, by the United 
States District Court, District of Maine. The proposed regulatory 
action would: prohibit the use of the term ``organic'' on products 
containing a minimum of 95 percent organic ingredients when such 
products also contain added synthetic ingredients unless such 
synthetics are otherwise authorized by statute or regulation, and 
prohibit anything less than 100 percent organic feed for organic dairy 
animals during conversion. The rulemaking must be completed by June 6, 
2006.


Statement of Need:


This regulatory action is needed to comply with a Consent Final 
Judgment and Order issued June 9, 2005, in the U.S. District Court for 
the District of Maine, in the case of Harvey v. Johanns (Civil No. 02-
216-P-H). This regulatory action must be completed within one year of 
the court order (June 9, 2006).


Summary of Legal Basis:


This regulatory action is required as part of the Consent Final 
Judgment and Order issued June 9, 2005, in the U.S. District Court for 
the District of Maine, in the case of Harvey v. Johanns (Civil No. 02-
216-P-H).


Alternatives:


There are no alternatives to this regulatory action as alternatives are 
precluded by the language of the court order and by the language of the 
Organic Foods Production Act (OFPA). The court has held that the OFPA 
prohibits the use of the term ``organic'' on products containing a 
minimum of 95 percent organic ingredients when such products also 
contain added synthetic ingredients unless such synthetics are 
otherwise authorized by statute or regulation; use of the USDA seal on 
such ``organic'' products is precluded. The court order also prohibits 
anything less than 100 percent organic feed for organic dairy animals 
during conversion.


Anticipated Cost and Benefits:


The agency's analysis of anticipated costs and benefits of the 
regulatory action is in the very early stages. The agency currently 
assumes zero benefits to the regulatory action.


The agency's early analysis indicates the costs of this regulatory 
action with respect to the dairy sector could exceed $4.1 million 
annually. Preliminary analysis of the costs of this regulatory action 
with respect to the processed products in on-going due to the 
complexity of the sector and associated product lines. Our analysis of 
this sector is based on an assumption that up to 90 percent of the 
multi-ingredient organic products will have to be relabeled as ``made 
with organic'' products. Sales revenue for such relabeled products may 
be affected by the court's prohibition of the use of the USDA seal. 
Therefore, the agency will also analyze the costs of manufacturer's 
investment in and goodwill associated with the USDA seal on products 
sold, labeled or represented as ``organic''.


Risks:


AMS has not identified any risks at this time.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State


Agency Contact:
Mark A. Bradley
Associate Deputy Administrator, National Organic Program
Department of Agriculture
Agricultural Marketing Service
Room 4008, South Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-3252
Fax: 202 205-7808
Email: [email protected]
RIN: 0581-AC54

[[Page 64102]]

_______________________________________________________________________



USDA--AMS

                              -----------

                            FINAL RULE STAGE

                              -----------




2. 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.


Legal Authority:


7 USC 1621 through 1627, Agricultural Marketing Act of 1946


CFR Citation:


7 CFR 60


Legal Deadline:


Final, Statutory, September 30, 2006.


Abstract:


The Farm Security and Rural Investment Act of 2002 (Farm Bill) (Pub. L. 
107-171) and the 2002 Supplemental Appropriations Act (2002 
Appropriations) (Pub. L. 107-206) amended the Agricultural Marketing 
Act of 1946 (Act) (7 U.S.C. 1621 et seq.) to require retailers to 
notify their customers of the country of origin of covered commodities 
beginning September 30, 2004. Covered commodities include muscle cuts 
of beef (including veal), lamb, and pork; ground beef, ground lamb, and 
ground pork; farm-raised fish and shellfish; wild fish and shellfish; 
perishable agricultural commodities; and peanuts. The FY 2004 
Consolidated Appropriations bill (2004 Appropriations) (Pub. L. 108-
199) delayed the implementation of mandatory COOL for all covered 
commodities except wild and farm-raised fish and shellfish until 
September 30, 2006.


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. 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. The 2004 
Appropriations delayed the implementation of mandatory COOL for all 
covered commodities except wild and farm-raised fish and shellfish 
until September 30, 2006.


Alternatives:


The October 30, 2004, proposed rule specifically invited comment on 
several alternatives including alternative definitions for ``processed 
food item,'' alternative labeling of mixed origin, and alternatives to 
using ``slaughtered'' on the label. In addition, the October 5, 2004, 
interim final rule contained an impact analysis which included an 
analysis of alternative approaches. The interim final rule also invited 
comment on several key issues including the definition of a processed 
food item.


Anticipated Cost and Benefits:


USDA has examined the economic impact of the rule as required by 
Executive Order 12866. The estimated benefits associated with this rule 
are likely to be small. The estimated 1st-year incremental cost for 
directly affected firms are estimated at $89 million for fish and 
shellfish only. The estimated cost to the U.S. economy in terms of 
reduced purchasing power resulting from a loss in productivity after a 
10-year period of adjustment are estimated at $6.2 million. A final 
cost benefit assessment for the other covered commodities will be 
completed in the final rule.


Risks:


AMS has not identified any risks at this time.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/30/03                    68 FR 61944
NPRM Comment Period End         12/29/03
Interim Final Rule              10/05/04                    69 FR 59708
Interim Final Rule 
    Comment Period End          01/03/05
Interim Final Rule 
    Effective                   04/04/05
Final Action                    09/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


State


Federalism:


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


Additional Information:


The U.S. Department of Agriculture issued an interim final rule with 
request for comments for the labeling of fish and shellfish covered 
commodities that will become effective on April 4, 2005. A final 
regulatory action for all covered commodities will be issued by 
September 30, 2006.


Agency Contact:
Erin Morris
Department of Agriculture
Agricultural Marketing Service
Poultry Program
14th & Independence Avenue, S.W.
Washington, DC 20250
Phone: 202 720-1749
Email: [email protected]
RIN: 0581-AC26
_______________________________________________________________________



USDA--AMS



3. CALIFORNIA CLINGSTONE PEACH DIVERSION PROGRAM (TREE PULL), FV05-82-
01

Priority:


Other Significant


Legal Authority:


7 USC 612c


CFR Citation:


7 CFR 82


Legal Deadline:


None


Abstract:


The Agricultural Marketing Service is proposing regulations to specify 
procedures for a voluntary program that offers a $100 per-acre payment 
to growers who remove a portion of their clingstone peach trees from 
production. Funds to remove the trees would come from both USDA and the 
industry, with the program implemented by the California Canning Peach 
Association. The Association is a grower-owned marketing and bargaining 
cooperative representing nearly 600 growers who produce 80 percent of 
the clingstone peaches grown in California. The program would ensure 
that removal is not part of a normal process of tree replacement. Also, 
the growers must guarantee that they have not made prior arrangements 
to sell the land or remove the trees for commercial purposes.

[[Page 64103]]

Statement of Need:


The program is designed to bring long-term clingstone peach supplies 
more in line with canned-market demands.


Summary of Legal Basis:


The program would be implemented under clause (3) of Section 32 of the 
Act of August 24, 1935, as amended, which allows the Secretary of 
Agriculture to use Section 32 funds to reestablish the purchasing power 
of U.S. farmers by making payments in connection with the normal 
production of any agricultural commodity for domestic consumption.


Alternatives:


The alternative of not establishing a tree removal program was also 
considered, however, under a tree removal program, supplies can be 
quickly aligned with demand.


Anticipated Cost and Benefits:


The major direct cost of the program would be the payment to growers 
for removing their clingstone peach trees. A total of $5 million, less 
the costs associated with local administration of the program, would be 
made available by USDA for the tree removal program. Administrative 
costs for reviewing applications and verifying tree removals are 
expected to be about $125,000. Total grower costs associated with the 
completion of diversion program applications, payment requests, and 
record maintenance for the period specified after tree removal are 
expected to be about $530. Payments made through this program could 
help California clingstone peach growers by addressing the over-supply 
problem that is adversely affecting their industry. The implementation 
of a tree removal program could reduce available supply more quickly 
than if the industry relied on market forces alone. While market forces 
could also result in supplies being reduced, such an adjustment may 
occur more slowly, with resultant economic hardships for growers and 
processors. In addition, a tree removal program could be beneficial in 
reducing the risk of loan default for lenders that financed clingstone 
peach growers. This program could also help small, under-capitalized 
growers stay in business.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            08/03/05                    70 FR 44525
NPRM Comment Period End         09/02/05
Final Action                    10/00/05

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Michael V. Durando
Chief, Marketing Order Administration Branch
Department of Agriculture
Agricultural Marketing Service
1400 Independence Avenue SW
STOP 0237
Washington, DC 20250-0237
Phone: 202 720-2491
Fax: 202 720-8938
RIN: 0581-AC45
_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




4. TUBERCULOSIS IN CATTLE; IMPORT REQUIREMENTS (SECTION 610 REVIEW)

Priority:


Other Significant


Legal Authority:


7 USC 8301 to 8317


CFR Citation:


9 CFR 93


Legal Deadline:


None


Abstract:


This rulemaking would amend the regulations regarding the importation 
of animals into the United States to establish several levels of risk 
classifications to be applied to foreign regions with regard to 
tuberculosis, and to establish requirements governing the importation 
of cattle based on each risk classification. These changes are 
necessary to help ensure that cattle infected with tuberculosis are not 
imported into the United States.


Statement of Need:


Bovine tuberculosis (tuberculosis) is a contagious, infectious, and 
communicable disease caused by Mycobacterium bovis. It affects cattle, 
bison, deer, elk, goats, and other warm-blooded species, including 
humans. Tuberculosis in infected animals and humans manifests itself in 
lesions of the lung, bone, and other body parts, causes weight loss and 
general debilitation, and can be fatal. At the beginning of the past 
century, tuberculosis caused more losses of livestock than all other 
livestock diseases combined. This prompted the establishment in the 
United States of the National Cooperative State/Federal Bovine 
Tuberculosis Eradication Program for tuberculosis in livestock. To 
protect against the spread of tuberculosis within the United States and 
aid in our domestic tuberculosis eradication effort, APHIS administers 
interstate movement regulations, which are contained in 9 CFR part 77. 
For the domestic eradication program to be successful, APHIS must also 
take measures to ensure that cattle imported into the United States are 
free of tuberculosis. The regulations governing the importation of 
cattle into the United States are contained in 9 CFR part 93.


Currently, the import regulations related to tuberculosis in cattle are 
the same for cattle from all foreign regions, with some exceptions for 
cattle imported from Mexico and Canada. Our domestic regulations, 
however, are based on the tuberculosis risk classification of States, 
or zones within States, and interstate movement requirements for cattle 
are based on the risk classification of the State or zone from which 
the cattle are moved. As our domestic eradication program has 
progressed, our criteria for State and zone classifications and 
corresponding interstate movement requirements have become more 
stringent. The import regulations need to be amended to be consistent 
with our domestic regulations and provide an equivalent level of 
protection.


Summary of Legal Basis:


The Animal Health Protection Act authorizes the Secretary of 
Agriculture to prohibit or restrict the importation, entry, and 
interstate movement of any article when necessary to prevent the 
introduction into or dissemination within the United States of any pest 
or disease of livestock.


Alternatives:


One alternative would be to maintain consistent import restrictions 
regardless of the region of origin of cattle. This alternative was 
rejected because it

[[Page 64104]]

would not recognize levels of risk in foreign regions and because our 
import regulations would be inconsistent with our domestic regulations.


Anticipated Cost and Benefits:


This rulemaking could reduce the number of tuberculosis tests required 
for some cattle imported into the United States from Mexico. 
Specifically, feeder cattle from areas of Mexico that qualify for 
advanced tuberculosis status might require one or no test instead of 
two tests. A decrease in testing requirements would result in some cost 
savings to exporters. Those savings could be passed on to feeder cattle 
buyers in the United States. This could result in an increase in the 
number of feeder cattle imported from Mexico, resulting in some losses 
for U.S. sellers of feeder cattle (cow-calf operations). Feeder cattle 
buyers and sellers in the border States of Arizona, California, New 
Mexico, and Texas would be most likely to be affected. These losses and 
gains are not expected to be significant, however.


Risks:


This action would base tuberculosis-related import requirements for 
cattle on the tuberculosis-risk of the region of origin. It is also 
expected to encourage control and eradication efforts in Mexico, which 
would reduce the tuberculosis risk presented by cattle imported from 
that country.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/00/06
NPRM Comment Period End         05/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Additional Information:


APHIS documents published in the Federal Register and related 
information are available on the Internet at http://www.aphis.usda.gov/
ppd/rad/webrepor.html.


Agency Contact:
Dr. Kelly Rhodes
Senior Staff Veterinarian, Regionalization Evaluation Services Staff, 
NCIE, VS
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road Unit 38
Riverdale, MD 20737-1231
Phone: 301 734-4356
RIN: 0579-AB44
_______________________________________________________________________



USDA--APHIS



5. ANIMAL WELFARE; REGULATIONS AND STANDARDS FOR BIRDS, RATS, AND MICE

Priority:


Other Significant


Legal Authority:


7 USC 2131 to 2159


CFR Citation:


9 CFR 3


Legal Deadline:


None


Abstract:


APHIS intends to establish standards for the humane handling, care, 
treatment, and transportation of birds other than birds bred for use in 
research and is considering establishing specific standards for rats 
and mice, other than rats of the genus Rattus and mice of the genus Mus 
bred for use in research.


Statement of Need:


The Farm Security and Rural Investment Act of 2002 amended the 
definition of animal in the Animal Welfare Act (AWA) by specifically 
excluding birds, rats of the genus Rattus, and mice of the genus Mus, 
bred for use in research. While the definition of animal in the 
regulations contained in 9 CFR part 1 has excluded rats of the genus 
Rattus and mice of the genus Mus bred for use in research, that 
definition has also excluded all birds (i.e., not just those birds bred 
for use in research). In line with this change to the definition of 
animal in the AWA, APHIS intends to establish standards in 9 CFR part 3 
for the humane handling, care, treatment, and transportation of birds 
other than those birds bred for use in research. Currently, the general 
standards in 9 CFR part 3, subpart F, apply to covered rats and mice. 
APHIS is also considering adopting specific standards for those 
animals.


Summary of Legal Basis:


The Animal Welfare Act (AWA) authorizes the Secretary of Agriculture to 
promulgate standards and other requirements governing the humane 
handling, care, treatment, and transportation of certain animals by 
dealers, research facilities, exhibitors, operators of auction sales, 
and carriers and immediate handlers. Animals covered by the AWA include 
birds, rats of the genus Rattus, and mice of the genus Mus that are not 
bred for use in research.


Alternatives:


To be identified.


Anticipated Cost and Benefits:


To be determined.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           06/04/04                    69 FR 31537
ANPRM Comment Period End        08/03/04
ANPRM Comment Period 
    Extended                    07/21/04                    69 FR 43538
ANPRM Comment Period End        11/01/04
NPRM                            09/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Additional Information:


APHIS documents published in the Federal Register and related 
information are available on the Internet at http://www.aphis.usda.gov/
ppd/rad/webrepor.html.


Agency Contact:
Jerry DePoyster
Senior Veterinary Medical Officer, Animal Care
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 84
4700 River Road
Riverdale, MD 20737-1234
Phone: 301 734-7586
Related RIN: Related to 0579-AB87
RIN: 0579-AB69

[[Page 64105]]

_______________________________________________________________________



USDA--APHIS



6. REVISION OF FRUITS AND VEGETABLES IMPORT REGULATIONS

Priority:


Other Significant


Legal Authority:


7 USC 450; 7 USC 7701 to 7772; 7 USC 8311; 21 USC 136 and 136a; 31 USC 
9701


CFR Citation:


7 CFR 305; 7 CFR 319; 7 CFR 352


Legal Deadline:


None


Abstract:


This rule would revise and reorganize the regulations pertaining to the 
importation of fruits and vegetables to consolidate requirements of 
general applicability and eliminate redundant requirements, update 
terms and remove outdated requirements and references, update the 
regulations that apply to importations into territories under U.S. 
administration, and make various editorial and nonsubstantive changes 
to regulations to make them easier to use. The rule would also make 
substantive changes to the regulations, including: (1) Establishing 
criteria within the regulations that, if met, would allow us to approve 
certain new fruits and vegetables for importation into the United 
States and to acknowledge pest-free areas in foreign countries without 
undertaking rulemaking; (2) doing away with the practice of listing 
specific commodities that may be imported subject to certain types of 
phytosanitary measures; and (3) providing for the issuance of special 
use permits for fruits and vegetables. These changes are intended to 
simplify and expedite our processes for approving certain new imports 
and pest-free areas while continuing to allow for public participation 
in the processes. If adopted, the rule would represent a significant 
structural revision of the fruits and vegetables import regulations and 
would establish a new process for approving certain new commodities for 
importation into the United States. It would not, however, allow the 
importation of any specific new fruits or vegetables, nor would it 
alter the conditions for importing currently approved fruits or 
vegetables except as specifically described in this document.


Statement of Need:


The volume of requests for new imports of fruits and vegetables has 
risen sharply in recent years with expanding global trade. APHIS is 
seeking an alternative process for certain new imports to expedite 
their evaluation and, where applicable, their approval.


Summary of Legal Basis:


Under the Plant Protection Act of 2000, it is the responsibility of the 
Secretary to facilitate . . . imports . . . in agricultural products 
and other commodities that pose a risk of harboring plant pests or 
noxious weeds in ways that will reduce, to the extent practicable, as 
determined by the Secretary, the risk of dissemination of plant pests 
or noxious weeds. This proposed rule, if adopted, would expedite the 
process for approving certain new imports.


Alternatives:


We considered making no changes to the existing fruit and vegetable 
import approval process, but the existing process can take upwards of 3 
years to complete, and simply is not as responsive enough in this era 
of increased global trade. We also considered designing a new expedited 
approval process which would apply to all imports, regardless of the 
type or extent of risk mitigation measures required. We determined that 
it would be better to gauge domestic support for a limited system prior 
to expanding its use to fruits and vegetables that may require 
complicated risk mitigation strategies that are derived from complex 
risk analyses--often for fruit and vegetable imports that may be 
opposed by domestic stakeholders due to economic issues.


Anticipated Cost and Benefits:


There would be no new costs associated with this rule. Benefits could 
include more timely action on import requests, which could also lead to 
reciprocal action by trading partners as they evaluate our export 
requests.


Risks:


This action is administrative in nature and poses no direct specific 
risks. If new import requests are evaluated using the system proposed 
in this rule, each would be based on a unique risk analysis.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            02/00/06
NPRM Comment Period End         04/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Additional Information:


APHIS documents published in the Federal Register and related 
information are available on the Internet at http://www.aphis.usda.gov/
ppd/rad/webrepor.html.


Agency Contact:
Karen Bedigian
Import Specialist, PIM, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road
Unit 140
Riverdale, MD 20737-1236
Phone: 301 734-4382
RIN: 0579-AB80
_______________________________________________________________________



USDA--APHIS



7. REVISION OF THE NURSERY STOCK REGULATIONS (SECTION 610 REVIEW)

Priority:


Other Significant


Legal Authority:


7 USC 450; 7 USC 7701 to 7772; 21 USC 136 and 136a


CFR Citation:


7 CFR 319


Legal Deadline:


None


Abstract:


APHIS intends to amend its regulations that govern the importation of 
nursery stock, also known as plants for planting. Under the current 
regulations, all plants for planting are allowed to enter the United 
States if they are accompanied by a phytosanitary certificate and if 
they are inspected and found to be free of plant pests, unless their 
importation is specifically prohibited or further restricted by the 
regulations. We are considering several possible changes to this 
approach, including establishing a category in the regulations for 
plants for planting that would be excluded from importation pending 
risk evaluation and approval; developing ongoing programs to reduce the 
risk of entry and establishment of quarantine pests via imported plants 
for planting; combining existing regulations governing the importation 
of plants for planting into one subpart; and reevaluating the risks 
posed by

[[Page 64106]]

importation of plants for planting whose importation is currently 
prohibited.


Statement of Need:


APHIS typically relies on inspection at a Federal plant inspection 
station or port of entry to mitigate the risks of pest introduction 
associated with the importation of plants for planting. Importation of 
plants for planting is further restricted or prohibited only if there 
is specific evidence that such importation could introduce a quarantine 
pest into the United States. Most of the taxa of plants for planting 
currently being imported have not been thoroughly studied to determine 
whether their importation presents a risk of introducing a quarantine 
pest into the United States. The volume and the number of types of 
plants for planting have increased dramatically in recent years, and 
there are several problems associated with gathering data on what 
plants for planting are being imported and on the risks such 
importation presents. In addition, quarantine pests that enter the 
United States via the importation of plants for planting pose a 
particularly high risk of becoming established within the United 
States. The current regulations need to be amended to better address 
these risks.


Summary of Legal Basis:


The Secretary of Agriculture may prohibit or restrict the importation 
or entry of any plant if the Secretary determines that the prohibition 
or restriction is necessary to prevent the introduction into the United 
States of a plant pest or noxious weed (7 USC 7712).


Alternatives:


APHIS has identified two alternatives to the approach we are 
considering. The first is to maintain the status quo; this alternative 
was rejected because, given our limited resources and the risks of pest 
introduction posed by the rapid increase in the importation of plants 
for planting, we do not believe that this approach would allow us to 
address the potential risks posed by quarantine pests in a timely 
manner. The second is to prohibit the importation of all nursery stock 
pending risk evaluation, approval, and notice-and-comment rulemaking, 
similar to APHIS's approach to regulating imported fruits and 
vegetables; this approach was rejected because, in the absence of 
additional resources for conducting risk evaluation and rulemaking, 
this approach would lead to a major interruption in international trade 
and would have significant economic effects on both U.S. importers and 
U.S. consumers of plants for planting.


Anticipated Cost and Benefits:


In general, the costs associated with plant pests that are introduced 
into the United States via imported nursery stock are expected to 
increase in the absence of some action to revise the nursery stock 
regulations to better address pest risks. Specific costs and benefits 
will be determined.


Risks:


In the absence of some action to revise the nursery stock regulations 
to allow us to better address pest risks, increased introductions of 
plant pests via imported nursery stock are likely, causing extensive 
damage to both agricultural and natural plant resources.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           12/10/04                    69 FR 71736
ANPRM Comment Period End        03/10/05
Comment Period Extended         03/10/05                    70 FR 11886
Comment Period End              04/11/05
Public Meeting and 
    Reopening of Comment 
    Period                      05/02/05                    70 FR 22612
Comment Period End              06/03/05
NPRM                            09/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Additional Information:


APHIS documents published in the Federal Register and related 
information are available on the Internet at http://www.aphis.usda.gov/
ppd/rad/webrepor.html.


Agency Contact:
Arnold T. Tschanz
Senior Staff Officer, Permits, Registrations and Imports, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road Unit 133
Riverdale, MD 20737-1236
Phone: 301 734-5306
RIN: 0579-AB85
_______________________________________________________________________



USDA--APHIS



8.  IMPORTATION OF BONELESS BEEF FROM JAPAN

Priority:


Other Significant


Legal Authority:


7 USC 8301 to 8317


CFR Citation:


9 CFR 94


Legal Deadline:


None


Abstract:


This rulemaking would amend the regulations governing the importation 
of meat and other edible animal products by allowing the importation of 
whole muscle-cuts of boneless beef derived from cattle born, raised, 
and slaughtered in Japan under conditions that would prevent the 
introduction of bovine spongiform encephalopathy.


Statement of Need:


APHIS regulates the introduction of meat and edible products from 
ruminants due to bovine spongiform encephalopathy (BSE) under 9 CFR 
part 94. In response to a request from the Government of Japan and 
after analyzing the risk associated with the importation of whole 
muscle-cuts of boneless beef derived from cattle born, raised, and 
slaughtered in Japan, APHIS has determined that it is unnecessary to 
continue to prohibit the importation this commodity from Japan, 
provided that certain conditions are met.


Summary of Legal Basis:


The Animal Health Protection Act authorizes the Secretary of 
Agriculture to prohibit or restrict the importation, entry, and 
interstate movement of any article if necessary to prevent the 
introduction into or dissemination within the United States of any pest 
or disease of livestock, including BSE.


Alternatives:


APHIS could have continued to prohibit the importation of whole muscle-
cuts of boneless beef from Japan or to impose a more restrictive set of 
import conditions. These alternatives were rejected because they are 
not necessary in order to prevent the introduction of BSE into the 
United States through boneless beef from Japan.


Anticipated Cost and Benefits:


Based on historic import levels and information from the Government of

[[Page 64107]]

Japan, APHIS expects this action to result in the importation from 
Japan of approximately 10 metric tons of boneless beef per year, which 
is a very small quantity when compared to U.S. boneless beef imports 
generally. Further, we expect that the type of beef imported would be 
Wagyu beef, which is a high-priced beef typically sold to a niche 
market of consumers. This action is expected to have little economic 
impact for most beef consumers and producers in the United States.


Risks:


This rulemaking sets import conditions that address the BSE-related 
risks of importing a commodity into the United States from a region 
where BSE is known to exist.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            08/18/05                    70 FR 48494
NPRM Comment Period End         09/19/05
Next Action Undetermined

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


None


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. Gary Colgrove
Director, National Center for Import and Export, VS
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 38
4700 River Road
Riverdale, MD 20737-1231
Phone: 301 734-4356
RIN: 0579-AB93
_______________________________________________________________________



USDA--APHIS

                              -----------

                            FINAL RULE STAGE

                              -----------




9. IMPORTATION OF SMALL LOTS OF SEED WITHOUT PHYTOSANITARY CERTIFICATES

Priority:


Other Significant


Legal Authority:


7 USC 450; 7 USC 7701 to 7772; 21 USC 136 and 136a


CFR Citation:


7 CFR 319


Legal Deadline:


None


Abstract:


This rulemaking would amend the nursery stock regulations to allow the 
importation of small lots of seed under an import permit with specific 
conditions as an alternative to the current phytosanitary certificate 
requirement. This proposed change is necessary because several entities 
that import small lots of seed--individual importers, horticultural 
societies, arboreta, and small businesses--have had difficulty 
obtaining the necessary certificates and have been adversely affected 
by the phytosanitary certificate requirement. The proposed change would 
make it feasible for those entities to import small lots of seed and 
would ensure prompt and consistent service for such importers while 
continuing to protect against the introduction of plant pests into the 
United States and providing the Animal and Plant Inspection Service 
with necessary information about the quality, quantity, and diversity 
of the imported material.


Statement of Need:


APHIS prohibits or restricts the importation of living plants, plant 
parts, and seeds for propagation to prevent the introduction of plant 
pests and noxious weeds into the United States. Recently, APHIS began 
requiring a phytosanitary certificate of inspection for all imported 
nursery stock, including small lots of seed. In response to requests 
from several entities who have had difficulty obtaining a phytosanitary 
certificate for small lots of seed or found the costs to be too high, 
APHIS is amending the regulations to allow small lots of seed to be 
imported under an import permit, with specific conditions, instead of 
with a phytosanitary certificate. APHIS has determined that this 
alternative for small lots of seed will provide an equivalent level of 
phytosanitary protection.


Summary of Legal Basis:


The Plant Protection Act (7 USC 7701 to 7773) authorizes the Secretary 
to prohibit or restrict the importation of any plant, plant product, or 
other article if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction of a plant pest 
into the United States.


Alternatives:


APHIS could have continued requiring that imported seeds be inspected 
and be accompanied by a phytosanitary certificate. However, in the 
countries that do offer inspection and certification services for small 
lots of seed, the costs of these services has been prohibitive for the 
seed importers. As a result, seed importers have either been unable to 
obtain the necessary phytosanitary certificates for small lots of seed 
or have had to pay fees that greatly exceeded the value of the seeds 
themselves. We rejected this alternative because maintaining the status 
quo would not be an economically feasible option for importers of small 
lots of seed, and because our preferred action imposes only those 
restrictions on the importation of small lots of seed that are 
necessary to prevent the introduction of plant pests into the United 
States.


Anticipated Cost and Benefits:


The changes will result in a slight cost increase for the Federal 
Government since import permits and the port of entry inspection 
activities are currently provided without a fee. If the changes result 
in increased importation of small lots of seed, there could also be a 
slight increase in the workload for processing the permits, but, since 
imports of small lots of seed are a very small fraction of the total 
domestic supply of seeds, no significant change in supply or price is 
expected.


However, as a result of these changes, seed importers will be able to 
more widely acquire new kinds of seeds to expand plant diversity, 
private gardeners will benefit from an increased availability of 
special seeds, the entry of imported seeds through plant inspection 
stations will provide APHIS with a more accurate picture of seed import 
activity, and we expect that the risk of the introduction or 
dissemination of plant diseases due to illegal importation will be 
reduced.

[[Page 64108]]

Risks:


This rulemaking sets import conditions that address the risks 
associated with importing small lots of seed into the United States.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            04/29/04                    69 FR 23451
NPRM Comment Period End         06/28/04
Final Rule                      12/00/05

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Additional Information:


APHIS documents published in the Federal Register and related 
information are available on the Internet at http://www.aphis.usda.gov/
ppd/rad/webrepor.html.


Agency Contact:
Arnold T. Tschanz
Senior Staff Officer, Permits, Registrations and Imports, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road Unit 133
Riverdale, MD 20737-1236
Phone: 301 734-5306
RIN: 0579-AB78
_______________________________________________________________________



USDA--APHIS



10. PHYTOPHTHORA RAMORUM; QUARANTINE AND REGULATIONS

Priority:


Other Significant


Legal Authority:


7 USC 7701 to 7772


CFR Citation:


7 CFR 301


Legal Deadline:


None


Abstract:


This action will amend the Phytophthora ramorum regulations to make the 
regulations consistent with a Federal Order issued by APHIS in December 
2004 and that established restrictions on the interstate movement of 
nursery stock from nurseries in nonquarantined counties in California, 
Oregon, and Washington. This action will also update conditions for the 
movement of regulated articles of nursery stock from quarantined areas, 
as well as restrict the interstate movement of all other nursery stock 
from nurseries in quarantined areas. We are also updating the list of 
plants regulated because of P. ramorum and the list of areas that are 
quarantined for P. ramorum and making other miscellaneous revisions to 
the regulations. These actions are necessary to prevent the spread of 
P. ramorum to noninfested areas of the United States. We will continue 
to update the regulations through additional rulemakings as new 
scientific information on this pathogen becomes available.


Statement of Need:


Since 1995, oaks and tanoaks have been dying in the coastal counties of 
California. Since then, other types of plants have been found to be 
infected or associated with this disease, referred to as Sudden Oak 
Death (SOD), ramorum leaf blight, ramorum dieback, or in Federal 
regulations, as Phytophthora ramorum. P. ramorum was first seen in 1995 
in Mill Valley (Marin County) on tanoak. Since that time, the disease 
has been confirmed on various native hosts in 14 coastal California 
counties (Marin, Santa Cruz, Sonoma, Napa, San Mateo, Monterey, Santa 
Clara, Mendocino, Solano, Alameda, Contra Costa, Humboldt, Lake, and 
San Francisco) and in Curry County, Oregon. The pathogen has been 
confirmed to infect 39 host plant taxa, and there are over 30 
additional taxa that are suspected to be hosts. In 2004, the pathogen 
was detected in plants shipped interstate from nonquarantined areas in 
California, Oregon, and Washington. Given the uncertainty associated 
with the spread of the pathogen and its potential effects on eastern 
oak forests, APHIS is taking action to define the extent of the 
pathogen's distribution in the United States and limit its artificial 
spread beyond infected areas through quarantine and a public education 
program. Completing this action is integral to having a scientifically 
sound quarantine as the foundation of our program.


Summary of Legal Basis:


The Plant Protection Act (7 USC 7701 to 7773) authorizes the Secretary 
to prohibit or restrict the movement in interstate commerce of any 
plant, plant product, or other article if the Secretary determines that 
the prohibition or restriction is necessary to prevent the 
dissemination of a plant pest within the United States.


Alternatives:


The two most significant alternatives APHIS considered were to (1) 
eliminate the Federal quarantine for P. ramorum because of the 
likelihood that the pathogen has already spread to other parts of the 
United States via interstate trade in articles that may be infested, 
and (2) quarantine the entire states of California, Oregon, and 
Washington and prohibit the interstate movement of P. ramorum host 
articles to protect against the interstate spread of the pathogen. We 
rejected the first alternative because of insufficient evidence about 
the presence of the pathogen in eastern U.S. nurseries or forests. The 
lack of evidence of spread despite the significant amount of trade in 
potentially infected material that has already occurred is the reason 
we did not select the second alternative. Our preferred action balances 
the need to protect eastern forests and nurseries with the goal of 
imposing only those restrictions on trade that are necessary to prevent 
the spread of the pathogen.


Anticipated Cost and Benefits:


The anticipated costs of this rulemaking mirror those of the Federal 
Order of 2004. Specifically, nurseries in regulated and quarantined 
areas will have to meet certain criteria prior to engaging in the 
interstate trade of nursery stock. Depending on the location of the 
nursery, the classification of nursery stock propagated within, and on 
the classification of articles to be shipped, the nursery will have to 
undergo annual inspection; and/or inspection, sampling, and testing of 
individual shipments in order to receive certification for interstate 
shipment. Currently, USDA covers the costs of annual inspection during 
normal business hours; however, as with all government subsidized 
programs, the budget allowable may differ from year to year. There are 
other intangible costs of rulemaking, such as the potential for lost 
revenue while holding plants during sampling and testing. Further, 
there has been some negative stigma associated with nursery stock from 
regulated areas of Oregon and Washington state as a result of the P. 
ramorum rulemaking and restrictions on interstate movement, although it 
is hard to quantify the effect of any perceived stigma.


Because knowledge of the P. ramorum pathogen and how it spreads is 
still in its infancy, the benefits of proactively

[[Page 64109]]

addressing the situation in hopes of preventing widespread infestation 
far outweigh any costs associated with the rulemaking. The total value 
of sales of nursery stock reported in 2004 from operations with 
$100,000 or more in sales in the United States was over $4.8 billion. 
California, Oregon, and Washington alone account for about 25 percent 
of that total, with sales of over $1.2 billion. With new hosts being 
consistently added to the list, and our knowledge of the pathogen's 
pathways increasing, this rulemaking is necessary, not only for 
protecting the nursery industry in the pacific northwest, but also for 
protecting the nursery industry nationwide.


Risks:


This rulemaking addresses risks associated with the interstate movement 
of articles that may spread P. ramorum to areas of the United States 
where the disease is not known to exist.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              12/00/05
Interim Final Rule 
    Comment Period End          02/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Local, State


Additional Information:


APHIS documents published in the Federal Register and related 
information are available on the Internet at http://www.aphis.usda.gov/
ppd/rad/webrepor.html.


Agency Contact:
Jonathan Jones
National Phytophthora Ramorum Program Manager, Pest Detection and 
Management Programs, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road Unit 160
Riverdale, MD 20737
Phone: 301 734-8247
RIN: 0579-AB82
_______________________________________________________________________



USDA--Food and Nutrition Service (FNS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




11. 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; 5) negative case reviews; and 6) 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/23/05
NPRM Comment Period Ends        12/22/05
Final Action                    10/00/06
Final Action Effective          11/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State

[[Page 64110]]

Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
Related RIN: Split from 0584-AD31
RIN: 0584-AD37
_______________________________________________________________________



USDA--FNS



12. SPECIAL NUTRITION PROGRAMS: FLUID MILK SUBSTITUTIONS

Priority:


Other Significant


Legal Authority:


PL 108-265, sec 102


CFR Citation:


7 CFR 210; 7 CFR 220


Legal Deadline:


None


Abstract:


Currently, by regulation, schools must make substitutions for fluid 
milk for students with a disability when the request is authorized by a 
licensed physician and may make substitutions for students with medical 
or other dietary needs if requested by recognized medical authority. 
These regulatory provisions were included in Public Law 108-265 which 
amended the Richard B. Russell National School Lunch Act. Public Law 
108-265 also amended the current law to allow schools to substitute 
non-dairy beverages nutritionally equivalent (as established by the 
Secretary) to fluid milk for medical or other special dietary needs at 
the request of a parent/guardian. In response to Public Law 108-265, 
the National School Lunch Program and School Breakfast Program 
regulations will be revised to add these provisions.


(04-016)


Statement of Need:


The changes made to the Richard B. Russell National School Lunch Act 
concerning substitutions for fluid milk are intended to assist children 
with an intolerance to or a cultural or other restriction concerning 
the consumption of milk. This regulation allows schools to make 
substitutions at the request of a parent or guardian which assists 
families that are unable to obtain a doctor's statement. However, the 
Secretary must develop criteria to limit the substitutions for milk to 
nutritionally equivalent beverages. The determination of nutritionally 
equivalent beverages will require careful research and consultation.


Summary of Legal Basis:


These changes are being made in response to provisions in Public Law 
108-265.


Alternatives:


USDA will be working with other Federal agencies to develop criteria 
for nutritionally equivalent substitutes for fluid milk as well as 
conducting research. USDA is issuing a proposed rule on this provision 
in order to solicit public comments prior to any final decisionmaking.


Anticipated Cost and Benefits:


Schools may incur additional costs in obtaining and offering substitute 
beverages. However, children who cannot consume milk will now have a 
nutritionally equivalent beverage to milk.


Risks:


USDA must be diligent in making any determinations of nutritional 
equivalency to milk.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Local, State


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD58
_______________________________________________________________________



USDA--FNS



13.  SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS 
AND CHILDREN (WIC): REVISIONS IN THE WIC FOOD PACKAGES

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 1786


CFR Citation:


7 CFR part 246


Legal Deadline:


Final, Statutory, November 2006, CN and WIC Reauthorization Act of 2004 
requires issuance of final rule within 18 months of release of IOM 
Report.


Abstract:


This proposed rule would revise regulations governing the WIC food 
packages to change age specifications for assignment to infant feeding 
packages; establish infant formula feeding or breastfeeding categories 
for infants; revise the maximum monthly allowances and minimum 
requirements for certain WIC foods; revise the substitution rates for 
certain WIC foods and allow additional foods as alternatives; add 
fruits and vegetables for WIC participants 6 months of age and older 
and eliminate juice from infants food package; add whole grains to food 
packages for children and women and baby food meat for fully breastfed 
infants 6 through 11 months of age; revise the purpose, content, and 
requirements for Food Package III; and address general provisions that 
apply to all food packages. The revisions reflect recommendations made 
by the Institute of Medicine in its report, WIC Food Packages: Time for 
a Change, and certain other administrative revisions deemed necessary 
by the Department. These revisions would bring the WIC food packages in 
line with the 2005 Dietary Guidelines for Americans and current infant 
feeding practice guidelines, better promote and support the 
establishment of successful long-term breastfeeding, provide WIC 
participants with a wider variety of food, provide WIC State agencies 
with greater flexibility in prescribing food packages to accommodate 
participants with cultural food preferences, and serve all participants 
with certain medical provisions under one food package to facilitate 
efficient management of medically fragile participants. (05-006)

[[Page 64111]]

Statement of Need:


The revisions proposed in this rulemaking reflect recommendations made 
by the Institute of Medicine (IOM) in its report, WIC Food Packages: 
Time for a Change, and certain administrative revisions deemed 
necessary by the Department. The Child Nutrition and WIC 
Reauthorization Act of 2004, enacted on June 30, 2004, requires the 
Department to issue a final rule within 18 months (November 2006) of 
receiving the IOM's report.


Summary of Legal Basis:


The Child Nutrition and WIC Reauthorization Act of 2004, enacted on 
June 30, 2004, requires the Department to issue a final rule within 18 
months of receiving the Institute of Medicine's report on revisions to 
the WIC food packages. This report was published and released to the 
public on April 27, 2005.


Alternatives:


FNS is in the process of developing a regulatory impact analysis that 
will address a variety of alternatives that are considered in the 
proposed rulemaking.


Anticipated Cost and Benefits:


The IOM was charged by FNS to develop recommendations that were cost-
neutral. The regulatory impact analysis will provide a more detailed 
summary of specific costs/benefits associated with the proposed 
revisions to the WIC Food Packages.


Risks:


The proposed rule has 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 revised WIC food 
packages will be offered to State agencies and other entities as 
necessary.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            01/00/06
NPRM Comment Period End         04/00/06
Interim Final Rule              11/00/06
Interim Final Rule 
    Effective                   11/00/06
Interim Final Rule 
    Comment Period End          05/00/08

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Local, State, Tribal


Federalism:


 Undetermined


URL For More Information:
www.fns.usda.gov/wic

URL For Public Comments:
www.fns.usda.gov/wic

Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD77
_______________________________________________________________________



USDA--FNS

                              -----------

                            FINAL RULE STAGE

                              -----------




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 rulemaking will amend Food Stamp Program regulations to implement 
11 provisions of the Farm Security and Rural Investment Act of 2002 
that establish new eligibility and certification requirements for the 
receipt of food stamps. (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 final 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 were 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 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 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 implements the 
certification and eligibility provisions of Public Law 107-171, the 
Farm Security and Rural Investment Act of 2002. It simplifies State 
administration of the Food Stamp Program, increases eligibility for the 
program among certain groups, increases access to the program among 
low-income families and individuals, and increases benefit levels. The 
provisions of this rule 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.

[[Page 64112]]

Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            04/16/04                    69 FR 20724
NPRM Comment Period End         06/15/04
Final Action                    12/00/05
Final Action Effective          02/00/06

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
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD30
_______________________________________________________________________



USDA--FNS



15. 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 final rule implements 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) 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                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              10/16/03                    68 FR 59519
Interim Final Rule 
    Effective                   12/15/03
Interim Final Rule 
    Comment Period End          01/14/04
Final Action                    10/00/06

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, Local, State


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



USDA--FNS



16. 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 final rule implements 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/19/04                    69 FR 12981
NPRM Comment Period End         05/18/04

[[Page 64113]]

Final Action                    12/00/05
Final Action Effective          02/00/06

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
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD32
_______________________________________________________________________



USDA--FNS



17. CATEGORICAL ELIGIBILITY AND DIRECT CERTIFICATION FOR FREE AND 
REDUCED PRICE MEALS AND FREE MILK IN SCHOOLS

Priority:


Other Significant


Legal Authority:


PL 108-265, sec 104


CFR Citation:


7 CFR 245


Legal Deadline:


None


Abstract:


In response to Public Law 108-265, which amended the Richard B. Russell 
National School Lunch Act, 7 CFR 245, Determining Eligibility for Free 
and Reduced Price Meals and Free Milk in Schools, will be amended to 
establish categorical (automatic) eligibility for free meals and free 
milk upon documentation that a child is (1) homeless as defined by the 
McKinney-Vento Homeless Assistance Act; (2) a runaway served by grant 
programs under the Runaway and Homeless Youth Act; or (3) migratory as 
defined in Sec. 1309(2) of the Elementary and Secondary Education Act. 
The rule also requires phase-in of direct certification for children 
who are members of households receiving food stamps and continues 
discretionary direct certification for other categorically eligible 
children. (04-018)


Statement of Need:


The changes made to the Richard B. Russell National School Lunch Act 
concerning direct certification are intended to improve program access, 
reduce paperwork, and improve the accuracy of the delivery of free meal 
benefits. This regulation will implement the statutory changes and 
provide State agencies and local educational agencies with the policies 
and procedures to conduct mandatory and discretionary direct 
certification.


Summary of Legal Basis:


These changes are being made in response to provisions in Public Law 
108-265.


Alternatives:


FNS will be working closely with State agencies to implement the 
changes made by this regulation and will be developing extensive 
guidance materials in conjunction with our cooperators.


Anticipated Cost and Benefits:


This regulation will reduce paperwork, target benefits more precisely, 
and will improve program access of eligible school children.


Risks:


This regulation may require adjustments to existing computer systems to 
more readily share information between schools, food stamp offices, and 
other agencies.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              03/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Governmental Jurisdictions


Government Levels Affected:


Local, State


Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
Related RIN: Merged with 0584-AD62
RIN: 0584-AD60
_______________________________________________________________________



USDA--FNS



18. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND 
CHILDREN (WIC): WIC VENDOR COST CONTAINMENT

Priority:


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


Legal Authority:


42 U.S.C. 1786


CFR Citation:


7 CFR 246


Legal Deadline:


Final, Statutory, December 2005.


Abstract:


This interim final rule amends the WIC regulations to strengthen vendor 
cost containment. The rule incorporates into program regulations new 
legislative requirements that affect the selection, authorization, and 
reimbursement of retail vendors. These requirements are contained in 
the Child Nutrition and WIC Reauthorization Act of 2004 (P.L. 108-265), 
which was enacted on June 30, 2004. The rule reflects the statutory 
provisions that require WIC State agencies to implement a vendor peer 
group system, competitive price selection criteria, and allowable 
reimbursement levels in a manner that ensures that the WIC Program pays 
authorized vendors competitive prices for supplemental foods. It also 
requires State agencies to ensure that vendors that derive more than 50 
percent of their annual food sales revenue from WIC food instruments do 
not result in higher food costs to the program than do other vendors. 
The intent of these provisions is to maximize the number of women, 
infants, and children served with available Federal funding. (04-029)


Statement of Need:


This action is needed to implement the vendor cost containment 
provisions of

[[Page 64114]]

the Child Nutrition and WIC Reauthorization Act of 2004, Public Law 
108-265. The rule requires WIC State agencies to operate vendor 
management systems that effectively contain food costs by ensuring that 
prices paid for supplemental foods are competitive. The rule also 
responds to data which indicate that WIC food expenditures increasingly 
include payments to a type of vendor whose prices are not governed by 
the market forces that affect most retail grocers. As a result, the 
prices charged by these vendors tend to be higher than those of other 
retail grocery stores participating in the program. To ensure that the 
program pays competitive prices, this rule codifies the new statutory 
requirements for State agencies to use in evaluating vendor applicants' 
prices during the vendor selection process and when paying vendors for 
supplemental foods following authorization.


Summary of Legal Basis:


Section 203 of Public Law 108-265, Child Nutrition and WIC 
Reauthorization Act of 2004.


Alternatives:


This rule implements the vendor peer group provisions of the Child 
Nutrition and WIC Reauthorization Act of 2004, which FNS believes is an 
effective means of controlling WIC food costs. While this Act mandates 
that States establish peer groups, competitive price criteria, and 
allowable reimbursement levels, and states that these requirements must 
result in the outcome of paying above-50-percent vendors no more than 
regular vendors, the rule does not specify particular criteria for peer 
groups or acceptable methods of setting competitive price criteria and 
allowable reimbursement levels. FNS considered mandating specific means 
of developing peer groups, competitive price criteria, and allowable 
reimbursement levels in order to ensure that the outcome of this 
legislation was achieved.


However, given States' responsibility to manage WIC as a discretionary 
grant program and the varying market conditions in each State, FNS 
believes that States need flexibility to develop their own peer groups, 
competitive price criteria, and allowable reimbursement levels. At the 
October 2004 meeting the FNS convened to gain input for this rule, 
States indicated that they needed the ability to design cost 
containment practices that would be effective in their own markets and 
would ensure participant access. In addition, there is little 
information about the effectiveness of particular cost containment 
practices in the variety of markets represented by the 89 WIC State 
agencies. Mandating more specific means of developing peer groups, 
competitive price criteria, and allowable reimbursement levels could 
have unintended negative consequences for participant access, food 
costs and administrative burden.


As States gain experience and the results of their vendor cost 
containment practices become apparent, FNS may develop further 
regulations and guidance to improve vendor cost containment. In the 
interim, FNS believes that the current rule will substantially 
accomplish the goal of the Act of containing food costs and ensuring 
that above-50-percent vendors do not result in higher costs to the WIC 
Program than regular vendors.


Anticipated Cost and Benefits:


Costs: This rule places new requirements on State agencies; therefore, 
the cost implications of this rule relate primarily to administrative 
burden for WIC State agencies. These cost implications are partially 
dependent on the current practices of State agencies relative to the 
requirements of the rule. Detailed information regarding the cost 
implications of this rule is contained in the Regulatory Impact 
Analysis developed by FNS to accompany this rulemaking.


Benefits: The WIC Program will benefit from the provisions of this rule 
by reducing unnecessary food expenditures, thus increasing the 
potential to serve more eligible women, infants, and children for the 
same cost. This rule should have the effect of ensuring that payments 
to vendors, particularly vendors that derive more than 50 percent of 
their annual food sales revenue from WIC food instruments, reflect 
competitive prices for WIC foods. The Regulatory Impact Analysis 
prepared by FNS to accompany this rulemaking projects an estimated 
monthly cost savings of over $6.25 million. (Details of this projection 
can be found in the complete Regulatory Impact Analysis.)


Risks:


Because the vendor peer group provisions in the Child Nutrition and WIC 
Reauthorization Act of 2004 and this rule provide for some flexibility 
in implementation, and because there is a wide degree of variation in 
food prices and current vendor cost containment practices across State 
agencies, the impact of many of the provisions of this rule is 
uncertain. Uncertainties include the administrative burden State 
agencies will incur and the savings that can be realized nationally or 
in any State agency. The major uncertainties for both administrative 
burden and program savings are discussed in greater detail in the 
Regulatory Impact Analysis.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              11/00/05
Interim Final Rule 
    Comment Period End          11/00/06
Interim Final Rule 
    Effective                   12/00/05
Final Action                    02/00/07
Final Action Effective          03/00/07

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, Local, State, Tribal


URL For More Information:
www.fns.usda.gov/wic

Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD71
_______________________________________________________________________



USDA--Food Safety and Inspection Service (FSIS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




19. PERFORMANCE STANDARDS FOR PUMPED OR MASSAGED BACON

Priority:


Other Significant


Legal Authority:


21 USC 601 et seq


CFR Citation:


9 CFR 424.22(b)

[[Page 64115]]

Legal Deadline:


None


Abstract:


FSIS is proposing to revise the regulatory provisions concerning the 
production and testing of pumped or massaged 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 or 
massaged bacon. FSIS is proposing to replace these provisions with an 
upper limit for nitrite and a performance standard that establishments 
producing pumped or massaged bacon must meet. To meet the proposed 
performance standard, the process used to produce pumped or massaged 
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 or massaged bacon with an upper limit for nitrite 
and a performance standard. The proposed performance standard concerns 
limiting the presence of volatile nitrosamines in pumped or massaged 
bacon. These proposed changes are necessary to make the regulations 
concerning pumped or massaged 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 or massaged bacon, they may be produced 
when the pumped or massaged 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 or massaged 
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 or massaged 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 or massaged bacon, FSIS does not 
anticipate that this proposed rule would result in any significant 
costs or benefits. Pumped or massaged 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 or massaged 
bacon product with wide consumer appeal.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program, and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC49
_______________________________________________________________________



USDA--FSIS



20. EGG PRODUCTS INSPECTION REGULATIONS

Priority:


Economically Significant. Major under 5 USC 801.


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 
egg products plants and establishments that pasteurize shell eggs 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 egg products and pasteurized shell eggs. 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 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. This proposal will not 
encompass shell egg packers. In the near future, FSIS will initiate 
non-regulatory outreach efforts

[[Page 64116]]

for shell egg packers that will provide information intended to help 
them to safely process shell eggs intended for human consumption or 
further processing.


The actions being proposed are part of FSIS' regulatory reform effort 
to improve FSIS' 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 
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 egg products plants and plants 
pasteurizing shell eggs to develop and implement HACCP systems and 
sanitation SOPs. FSIS also is proposing pathogen reduction performance 
standards that would be applicable to pasteurized shell eggs and egg 
products. Plants would be expected to develop HACCP systems that ensure 
that these products meet the lethality required by the pathogen 
reduction performance standards. In addition, FSIS is proposing to 
amend the Federal 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 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, 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 four States and the Commonwealth 
of Puerto Rico under which they provide inspection services to egg 
processing plants under Federal jurisdiction. FSIS reimburses the 
States for staffing costs and expenses for full-time State inspectors. 
HACCP implementation may result in a reduction of staffing resource 
requirements in the States and a corresponding reduction of the Federal 
reimbursement. As a result, some States may decide to stop providing 
inspection services and convert to Federal inspection of egg products 
plants.


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


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


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


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


Risks:


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


To assess the potential risk-reduction impacts of this rulemaking on 
the public, an intra-Agency group of

[[Page 64117]]

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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Federal, State


Federalism:


 Undetermined


Agency Contact:
Viki Levine
Program Analyst, Regulations and Petitions Policy Staff
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 720-5627
Fax: 202 690-0486
Email: [email protected]
RIN: 0583-AC58
_______________________________________________________________________



USDA--FSIS



21. PERFORMANCE STANDARD FOR CHILLING OF 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 a performance standard for the chilling of ready-to-
cook poultry products that is intended to ensure the control of 
microorganisms on the products from a point after evisceration until 
the products are frozen, further processed, or packaged for shipment 
from the processing plant. The current specific time and temperature 
requirements for chilling poultry carcasses of various weights would be 
retained as alternative requirements that poultry processors could 
choose to meet. FSIS is taking this action to provide poultry 
processors with greater flexibility in achieving the purposes of the 
poultry chilling requirements whilst complying with the Agency's Hazard 
Analysis and Critical Control Point (HACCP) and other regulations. This 
proposal responds to petitions from 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 second alternative but would make the existing 
requirements a ``safe harbor.''


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 those which are unavoidable for food-safety purposes. They 
would be able to operate with a wider range of chilling temperatures 
consistent 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 64118]]

Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program, and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC87
_______________________________________________________________________



USDA--FSIS



22. SHARING OF FIRMS' DISTRIBUTION LISTS OF RETAIL CONSIGNEES DURING 
MEAT OR POULTRY PRODUCT RECALLS

Priority:


Other Significant


Legal Authority:


5 USC 301, 552


CFR Citation:


9 CFR 390


Legal Deadline:


None


Abstract:


The Food Safety and Inspection Service (FSIS) is proposing to amend the 
federal meat and poultry products inspection regulations to provide 
that the Agency will make available to the public lists of the retail 
consignees of meat and poultry products that have been voluntarily 
recalled by a federally inspected meat or poultry products 
establishment. FSIS is proposing this action because it believes that 
making this information available will be of significant value to 
consumers and the industry. It will clarify what products should be 
removed from commerce and from consumers' possession because there is 
reason to believe they are adulterated or misbranded.


Statement of Need:


The objective to be accomplished by this regulatory action is to 
provide important information to consumers while ensuring the 
appropriate flexibility for FSIS to protect proprietary information.


While FSIS does not have mandatory recall authority under the Federal 
Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry 
Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), the Agency, to 
protect the public health, does ask establishments to voluntarily 
recall adulterated or misbranded meat and poultry products. FSIS 
verifies that such recalls are conducted expeditiously and effectively.


In 2002, FSIS promulgated regulations defining the circumstances and 
criteria under which it would share customer lists with States and 
other Federal agencies in connection with voluntary meat and poultry 
product recalls. In short, FSIS will disclose product distribution 
lists that have been obtained during voluntary recalls to States and 
other Federal government agencies to verify the removal of the recalled 
product, provided that the State or Federal agency has provided: (1) A 
written statement establishing its authority to protect confidential 
distribution lists from public disclosure and (2) a written commitment 
not to disclose any information provided by FSIS without the written 
permission of the submitter of the information or written confirmation 
by FSIS that the information no longer has confidential status. 
Currently, FSIS will not disclose distribution lists to the general 
public or to States or other Federal government agencies that have not 
provided to FSIS the written statement and commitment required by the 
Agency's Freedom of Information and public information regulations.


Consumer activists and States have increasingly demanded the public 
release of information on where recalled meat and poultry products have 
been shipped. The States have requested this information be provided 
without the limitations imposed by FSIS's regulations. Consumer groups 
have claimed that the public needs this information to fully protect 
itself. In response to these requests, FSIS is proposing to make 
available to the public the names of likely retail consignees of 
recalled meat and poultry products.


Summary of Legal Basis:


This proposed rule is authorized under 5 U.S.C. section 301, 
Departmental regulations, and 5 U.S.C. section 552, Public information; 
agency rules, opinions, orders, records, and proceedings. It is not the 
result of any specific mandate by the Congress or a Federal court.


Alternatives:


FSIS is preparing a regulatory impact analysis to evaluate the 
potential economic impacts of several alternatives on the public, the 
meat and poultry industry, and FSIS. These alternatives include: (1) 
Taking no regulatory action; (2) including local health departments as 
entities that could receive recall distribution lists; (3) making 
available to the general public, without any limitations, recall 
distribution lists, including all levels of distributors; (4) requiring 
recalling establishments to make their distribution lists available to 
any member of the public who requests it; and (5) allowing the Agency 
to make available to the general public the names of likely retail 
consignees of recalled meat and poultry products.


Anticipated Cost and Benefits:


FSIS is analyzing the potential costs of this proposed rulemaking.


This proposed rule would provide information to consumers about meat 
and poultry products sold at retail establishments that are believed to 
be adulterated or misbranded and are therefore subject to being 
recalled. The consumption of such products may cause food borne illness 
and other adverse health consequences, including death. Providing 
information of this sort that is more accessible and likely to be used 
by the consumer will reduce the likelihood of food borne illnesses and 
related consequences.


Risks:


FSIS believes that this regulatory action may result in a further 
reduction in the risks associated with the consumption of meat and 
poultry products.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Agency Contact:
Mr. Philip Derfler
Assistant Administrator, Office of Policy, Program, and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 350, Jamie L. Whitten Building
1400 Independence Avenue SW
Washington, DC 20250-3700
Phone: 202 720-2709
Fax: 202 720-2025
Email: [email protected]
RIN: 0583-AD10

[[Page 64119]]

_______________________________________________________________________



USDA--FSIS

                              -----------

                            FINAL RULE STAGE

                              -----------




23. PERFORMANCE STANDARDS FOR THE PRODUCTION OF PROCESSED MEAT AND 
POULTRY PRODUCTS

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


21 USC 451 et seq; 21 USC 601 et seq


CFR Citation:


9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR 
325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430; 9 CFR 431


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. With HACCP, food safety 
performance standards 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 direct industry-wide costs are estimated 
at $23.3 million on an annual basis. Annual net benefits are estimated 
at about $26.2 million annually. Benefits are expected to result from 
the entry into commercial food distribution channels of product with 
lower levels of contamination resulting from improved in-plant process 
verification and sanitation.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            02/27/01                    66 FR 12590
NPRM Comment Period End         05/29/01
NPRM Comment Period 
    Extended                    07/03/01                    66 FR 35112
NPRM Comment Period End         09/10/01
Interim Final Rule              06/06/03                    68 FR 34208
Interim Final Rule 
    Effective                   10/06/03
Interim Final Rule 
    Comment Period End          01/31/05
NPRM Comment Period 
    Reopened                    03/24/05                    70 FR 15017
NPRM Comment Period End         05/09/05
Final Action                    09/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined

[[Page 64120]]

Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program, and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC46
_______________________________________________________________________



USDA--FSIS



24. NUTRITION LABELING OF SINGLE-INGREDIENT PRODUCTS AND GROUND OR 
CHOPPED MEAT AND POULTRY PRODUCTS

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


21 USC 601 et seq; 21 USC 451 et seq


CFR Citation:


9 CFR 317; 9 CFR 381


Legal Deadline:


None


Abstract:


FSIS has proposed to amend the Federal meat and poultry products 
inspection regulations to require nutrition labeling for the major cuts 
of single-ingredient, raw meat and poultry products, either on their 
label or at their point-of-purchase, unless an exemption applies. FSIS 
also proposed to require nutrition information on the label of ground 
or chopped meat and poultry products, unless an exemption applies. The 
requirements for ground or chopped products will be consistent with 
those for multi-ingredient products.


FSIS also proposed to amend the nutrition labeling regulations to 
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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            01/18/01                     66 FR 4970
NPRM Comment Period End         04/18/01
Extension of Comment 
    Period                      04/20/01                    66 FR 20213
NPRM Comment Period End         07/17/01
Final Action                    09/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Robert Post, Ph.D.
Director, Labeling and Consumer Protection Staff
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
Email: [email protected]
RIN: 0583-AC60
_______________________________________________________________________



USDA--FSIS



25. FOOD STANDARDS; GENERAL PRINCIPLES AND FOOD STANDARDS MODERNIZATION

Priority:


Other Significant


Legal Authority:


21 USC 601 et seq; 21 USC 451 et seq; 21 USC 321 et seq

[[Page 64121]]

CFR Citation:


9 CFR 410; 21 CFR 130


Legal Deadline:


None


Abstract:


The Food Safety and Inspection Service (FSIS) and the Food and Drug 
Administration (FDA) are proposing to modernize their food standards. 
The agencies are proposing a set of general principles for food 
standards. The adherence to these principles will result in standards 
that will better promote honesty and fair dealing in the interest of 
consumers, protect the public, allow for technological advances in food 
production, are consistent with international food standards, and are 
clear, simple, and easy to use for both manufacturers and the agencies 
that enforce compliance with the standards. The proposed general 
principles will establish the criteria that the agencies will use in 
considering whether a petition to establish, revise, or eliminate a 
food standard will be the basis for a proposed rule.


Statement of Need:


This rule is necessary to modernize FDA and FSIS food standards, so 
that they are consistent with the agencies' authorizing statutes, allow 
for technological advances in food production, are consistent with 
international food standards to the extent feasible, and are clear, 
simple, and easy to use for both manufacturers and the agencies that 
enforce compliance with the standards.


Summary of Legal Basis:


Under 21 U.S.C. 341, FDA has authority to fix and establish standards 
of identity, standards of quality, or standards of fill of container 
for food products regulated by FDA, when such regulations will promote 
honesty and fair dealing in the interest of consumers. Similarly, under 
21 U.S.C. 607(c) and 457(b), FSIS has authority to establish meat and 
poultry product standards of identity or composition whenever such 
regulations are necessary for the protection of the public. The 
proposed rule will ensure that FDA and FSIS food standards are 
consistent with the authorizing statutes.


Alternatives:


In addition to the option chosen, the Agencies considered the following 
options: 1) No action; 2) removing all food standards from the 
regulations and treating all foods as nonstandardized foods; 3) using 
Agency resources to review and revise food standards rather than 
relying on external petitions; and 4) requesting external industry 
groups to review, revise, and administer the food standards (private 
certification).


Anticipated Cost and Benefits:


Establishing general principles for food standards ensures that FSIS 
and FDA use a consistent and systematic approach when assessing 
standards. These principles would also apprise external parties of the 
framework FDA and FSIS intend to use when assessing standards, thereby 
reducing the costs for external parties to petition the agencies to 
change standards. An additional benefit is that establishing the set of 
principles specified in this proposed rule ensures that FDA and FSIS 
assess standards with respect to their ability to reduce consumers' 
search costs, while also reducing the likelihood that standards will 
impose unnecessary costs, or reduce competition and thereby increase 
prices.


FSIS and FDA expect the costs associated with this rule to be small and 
the benefits to be relatively substantial. Therefore, the Agencies 
believe that the benefits of establishing the proposed principles 
outweigh the costs.


Risks:


None


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            05/20/05                    70 FR 29214
Other/Final Rule                09/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Robert Post, Ph.D.
Director, Labeling and Consumer Protection Staff
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
Email: [email protected]
RIN: 0583-AC72
_______________________________________________________________________



USDA--FSIS



26. PROHIBITION OF THE USE OF SPECIFIED RISK MATERIALS FOR HUMAN FOOD 
AND REQUIREMENTS FOR THE DISPOSITION OF NON-AMBULATORY DISABLED CATTLE

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


21 USC 601 et seq


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


On January 12, 2004, the Food Safety and Inspection Service (FSIS) 
issued an interim final rule to amend the Federal meat inspection 
regulations to designate the brain, skull, eyes, trigeminal ganglia, 
spinal cord, vertebral column (excluding the vertebrae of the tail, the 
transverse processes of the thoracic and lumbar vertebrae, and the 
wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months 
of age and older, and the tonsils and distal ileum of the small 
intestine of all cattle, as ``specified risk materials'' (SRMs). The 
Agency declared that SRMs are inedible and prohibited their use for 
human food. In addition, as a result of the interim final rule, FSIS 
now requires that all non-ambulatory disabled cattle presented for 
slaughter be condemned. The Agency also requires that federally 
inspected establishments that slaughter cattle and federally inspected 
establishments that process the carcasses or parts of cattle develop, 
implement, and maintain written procedures for the removal, 
segregation, and disposition of SRMs. Establishments must incorporate 
these procedures into their HACCP plans or in their Sanitation SOPs or 
other prerequisite program. FSIS took this action in response to the 
diagnosis on December 23, 2003, by the U.S. Department of Agriculture 
of a positive case of bovine spongiform encephalopathy (BSE) in an 
adult Holstein cow in the State of Washington. This action is intended 
to minimize human exposure to materials that scientific studies have 
demonstrated as containing the BSE agent in cattle infected with the 
disease. Infectivity has never been demonstrated in the muscle tissue 
of

[[Page 64122]]

cattle experimentally or naturally infected with BSE at any stage of 
the disease.


Statement of Need:


FSIS issued an interim final rule to amend the meat inspection 
regulations to add provisions to prevent meat and meat products that 
may contain the BSE agent from entering commerce.


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. 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. 
Both BSE and vCJD are always fatal.


USDA policy in regard to BSE has been to be proactive and preventive. 
The regulations: (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) 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 (5) 
prescribe requirements for the sanitation or disposal of plant 
equipment that may be contaminated with the BSE agent.


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 interim final rule, 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.


Anticipated Cost and Benefits:


This interim final rule could 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 could result in a decrease in product yield and may 
require companies that use these systems to produce boneless beef and 
beef products to find other uses for bovine vertebral column. 
Establishments whose equipment may have been contaminated with the BSE 
agent may have costs associated with sanitation or disposal of plant 
equipment.


FSIS may incur costs to increase inspection and compliance activities 
to ensure that the measures taken to prevent meat and meat food 
products that may contain the BSE agent from entering commerce are 
effective. Producers may receive lower prices from processors, and some 
of their stock may be condemned outright. The price consumers pay for 
meat may rise or fall depending on how the discovery of BSE in the U.S. 
affects 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, the interim final rule 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 interim final rule may benefit the meat industry by helping to 
restore confidence in the domestic meat supply. 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 interim final 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 implemented 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 used the findings of the risk 
assessment to inform its decision to prohibit certain bovine materials 
for human food.


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, additional measures to reduce 
the risk of human exposure to the BSE agent are necessary to protect 
public health.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              01/12/04                     69 FR 1862
Interim Final Rule 
    Comment Period End          05/07/04
Interim Final Rule 
    Amendment                   07/07/05                    70 FR 53043
Interim Final Rule 
    Amendment Comment 
    Period End                  10/07/05
Final Action                    09/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined

[[Page 64123]]

Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program, and Employee 
Development
Department of Agriculture
Food Safety and Inspection Service
Room 402 Cotton Annex Building
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0495
Fax: 202 401-1760
Email: [email protected]
RIN: 0583-AC88
_______________________________________________________________________



USDA--Forest Service (FS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




27.  TRAVEL MANAGEMENT (PROPOSED DIRECTIVES, FOREST SERVICE 
MANUAL 2300 AND 7700)

Priority:


Other Significant


Legal Authority:


E.O. 11644


CFR Citation:


None


Legal Deadline:


None


Abstract:


Once the final regulation entitled ``Travel Management; Designated 
Routes and Areas for Motor Vehicle Use (36 CFR part 212)'' is adopted, 
the Forest Service is planning to publish proposed directives to 
implement the regulation. The proposed directive changes are needed to 
provide guidance on implementation of the Travel Management regulation, 
conform terminology to the rule, and provide consistent direction on 
the process of designating roads, trails, and areas for motor vehicle 
use.


The proposed changes consolidate policy for travel planning for roads 
and trails in FSM 7710, while retaining separate chapters related to 
operations and maintenance for roads (FSM 7730) and trails (FSM 2350). 
The changes would expand the scope of the current roads analysis 
process to encompass motorized trails and areas, while streamlining 
travel analysis to ensure that it is completed in a timely manner.


Statement of Need:


Motor vehicles are a legitimate use of NFS lands -- in the right 
places, and with proper management. Current regulations at 36 CFR part 
295 were developed when Off-Highway Vehicles (OHVs) were less widely 
available and less powerful than today's models. The growing popularity 
and capabilities of OHVs demand new regulations so that the Forest 
Service can continue to provide these opportunities, while sustaining 
the health of NFS lands and resources. From 1972 to 2004, the number of 
Americans driving motor vehicles off road increased by a factor of ten. 
Whole new classes of vehicles have been introduced by manufacturers. 
These advances expand opportunities for Americans to enjoy Federal 
lands. However, the magnitude and intensity of motor vehicle use have 
increased to the point that without careful management, soil erosion, 
water quality, wildlife habitat, adjacent property owners, and the 
experiences of other visitors can be affected.


The clear identification of roads, trails, and areas for motor vehicle 
use on each National Forest will enhance management of National Forest 
System lands; sustain natural resource values through more effective 
management of motor vehicle use; enhance opportunities for motorized 
recreation experiences of National Forest System lands; address needs 
for access to National Forest System lands; and preserve areas of 
opportunity on each National Forest for nonmotorized travel and 
experiences.


On July 15, 2004, the Forest Service published a proposed rule in the 
Federal Register (69 FR 42381) seeking public comment in amending 
regulations at 36 CFR parts 212, 251, 261, and 295 to clarify policy 
related to motor vehicle use on NFS lands, including the use of OHVs. 
During the 60-day comment period that ended on September 13, 2004, the 
agency received 81,563 letters or electronic messages in response to 
the proposed rule. The final rule includes a response to comments 
submitted on the proposed rule.


Summary of Legal Basis:


There is no aspect of this action that is required by statute or court 
order. The final Travel Management rule is needed to provide consistent 
management of motor vehicle use on NFS lands so that the Forest Service 
can better meet the direction of E.O. 11644 and E.O. 11989.


Alternatives:


As an alternative to publishing the final Travel Management rule, the 
Forest Service could continue to operate under current regulations at 
36 CFR part 295. These existing regulations provide that motor vehicle 
use off roads may be allowed, prohibited, or restricted, as determined 
through individual land management plans. Management of motor vehicle 
use under existing regulations has been inconsistent from one National 
Forest to another, and has sometimes failed to either keep pace with 
increasing demand or prevent damage to natural resources.


Anticipated Cost and Benefits:


The benefits and costs of the final rule and related proposed 
directives are described qualitatively because the rule is procedural. 
Actual travel management decisions will be made by field units with 
public input and appropriate environmental analysis and documentation. 
The benefits of the final rule include gains to users, the agency, and 
the environment. Sustainable, reliable, high-quality public access to 
National Forest System lands will lead to enhanced recreation 
opportunities for visitors. Both users and the agency will benefit from 
improved public communication, more effective law enforcement, and 
improved travel management planning. Other benefits include reduced 
environmental damage and a more consistent and defensible travel 
planning framework. The costs of the final rule include reductions in 
unconstrained cross-country motor vehicle use for those that value this 
activity, and short-term agency planning costs as many National Forests 
launch travel planning efforts following adoption of the rule.


Risks:


There are no risks addressed by the final rule and related proposed 
directives. Unmanaged cross-country motor vehicle travel can affect 
soil, water quality, wildlife habitat, cultural and historic resources, 
invasive species, private property owners, and the experiences of other 
recreational visitors. A managed system of routes and areas designated 
for motor vehicle use can provide sustainable recreation opportunities 
for visitors while addressing these effects. The final Travel 
Management rule will provide a consistent national framework for making 
travel management decisions at the local level, with public 
participation and appropriate environmental analysis.

[[Page 64124]]

Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Proposed Directive              01/00/06

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 Branch
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 202 205-3610
Fax: 202-260-6539
Email: [email protected]
RIN: 0596-AC39
BILLING CODE 3410-90-S

[[Page 64125]]




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 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 primary operating units, 
only the National Oceanic and Atmospheric Administration (NOAA) plans a 
``most important'' significant preregulatory or regulatory action for 
this Regulatory Plan year. NOAA plans to complete two actions and has 
completed four actions that rise to the level of ``most important'' of 
the Department's ``significant regulatory actions''. The actions that 
will be completed in the next year are entitled: (1) Northwest Hawaiian 
Islands National Marine Sanctuary; Designation and Implementing 
Regulations; and (2) Fisheries of the United States; National Standard 
1. The actions that have been completed are: (1) Amendments 18 and 19 
to the Fishery Management Plan for Bering Sea/Aleutian Islands King and 
Tanner Crabs - Crab Rationalization Program; (2) Designate Critical 
Habitat

[[Page 64126]]

for 7 Evolutionarily Significant Units (ESUs) of Pacific Salmon and 
Steelhead in California; (3) Designate Critical Habitat for 12 
Evolutionarily Significant Units (ESUs) of Pacific Salmon and Steelhead 
in Washington and Oregon; and (4) and Listing Determinations for 27 
Evolutionarily Significant Units (ESUs) of West Coast Salmon and 
Oncorhynchus Mykiss. Further information on these actions are 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 rulemaking is triggered by an FMC, the Magnuson-Stevens 
Act places stringent deadlines upon NMFS by which it must exercise its 
rulemaking responsibilities.

[[Page 64127]]

While most of these rulemakings will be minor, involving only the 
opening or closing of a fishery under an existing FMP, five actions are 
of particular significance and have been designated as the most 
important regulatory actions undertaken by the Department. In the 
action entitled ``Northwest Hawaiian Islands National Marine Sanctuary; 
Designation and Implementation of Regulations,'' NOAA plans to 
designate the Northwest Hawaiian Islands as a national marine sanctuary 
and propose implementing regulations that best reflect the goals and 
objectives of the proposed sanctuary. In the action entitled 
``Fisheries of the United States; National Standard 1,'' NMFS amends 
the national standard guidelines for national standard 1 to revise the 
criteria for determining overfishing and establishing rebuilding 
schedules. The four remaining actions that have been designated as the 
most important regulatory actions have been completed during the past 
year. In the action entitled ``Amendments 18 and 19 to the to the 
Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner 
Crabs in the Bering Sea and the Aleutian Islands - Crab Rationalization 
Program,'' NMFS rationalized the Bering Sea and Aleutian Islands crab 
fisheries in the United States Exclusive Economic Zone off Alaska by 
amending the Fishery Management Plan for Bering Sea and Aleutian 
Islands King and Tanner Crabs. The goal of rationalization is to end 
the race for fish and solve the problems of overcapacity while 
providing for a balanced distribution of benefits and improving 
fisheries management and resource conservation. In the action entitled 
``Listing Determinations for 27 ESUs of West Coast Salmon and 
Oncorhynchus Mykiss,'' NMFS listed ESUs as endangered or threatened, 
and also delisted ESUs as necessary. Finally, in the actions entitled 
``Designate Critical Habitat for 7 Evolutionarily Significant Units 
(ESUs) of Pacific Salmon and Steelhead in alifornia`'' and ``Designate 
Critical Habitat for 12 Evolutionarily Significant Units (ESUs) of 
Pacific Salmon and Steelhead in Washington and Oregon'' NMFS designated 
critical habitat for 20 Pacific salmon and O. mykiss Evolutionarily 
Significant Units (ECUS) listed under the Endangered Species Act of 
1973. The geographic areas designated as critical habitat included 
lakes, riverine, and estuarian habitat in Washington, Oregon, Idaho, 
and California.
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

[[Page 64128]]

            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.
_______________________________________________________________________



DOC--National Oceanic and Atmospheric Administration (NOAA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




28. NORTHWEST HAWAIIAN ISLANDS NATIONAL MARINE SANCTUARY; DESIGNATION 
AND IMPLEMENTATION OF REGULATIONS

Priority:


Other Significant


Legal Authority:


PL 106-513; 16 USC 1431 et seq


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


The National Marine Sanctuaries Program, together with State and 
Federal partners and other stakeholders, designates the Northwest 
Hawaiian Islands as a national marine sanctuary and implements 
regulations that best reflects the goals and objectives of the proposed 
sanctuary.


Statement of Need:


By designating the Northwest Hawaiian Islands (NWHI) as a national 
marine sanctuary, the National Marine Sanctuary Program (NMSP), 
together with state and federal partners and other stakeholders, hope 
to catalyze the collaborative development of an ecosystem approach to 
address management issues. The NWHI are among the few, large-scale, 
intact, predator-dominated coral reef ecosystems left in the world. 
Significant Native Hawaiian cultural and maritime historical resources 
are found throughout the region. These vast and remote coral reef 
ecosystems support a distinctive assemblage of marine mammals, fish, 
sea turtles, birds, and invertebrates, including species that are 
endemic, rare, threatened, or endangered. Unfortunately, coral reef 
systems like the NWHI are in a state of decline as direct or indirect 
result of human activities.


Fishing is one of many human activities that may have direct and 
indirect effects on the health and integrity of coral reef ecosystems. 
Some of the direct impacts of fishing on coral reef ecosystems include 
depletion of fish stocks and habitat degradation. Examples of indirect 
effects include shifts in community structure and predatory-prey 
relationships. Historically, fisheries management approaches have been 
conducted through a single species approach. While this fishery 
management approach can provide valuable information, it does not 
consider the broader impacts of the activity on an ecosystem. The NMSP 
and the National Oceanic and Atmospheric Administration (NOAA) as a 
whole are working toward an ecosystem approach to resource management. 
This form of management is adaptive, is geographically specified, takes 
account of ecosystem knowledge and uncertainties, considers multiple 
external influences, and strives to balance diverse social objectives. 
Fishing in the NWHI must be carefully considered and evaluated in the 
context of an ecosystem approach to management in order to achieve a 
healthy, functional, and resilient ecosystem.


Summary of Legal Basis:


The NMSP of NOAA is in the process of designating the Northwest 
Hawaiian Islands Coral Reef Ecosystem Reserve (Reserve) as a national 
marine sanctuary as directed by the National Marine Sanctuaries 
Amendments Act (NMSAA) of 2000 and Executive Orders 13178 and 13196, 
and in accordance with the National Marine Sanctuaries Act (NMSA). The 
Reserve was established in 2000 by E.O. 13178 with the principal 
purpose of long-term conservation and protection of the coral reef 
ecosystem and related marine resources and species of the Northwest 
Hawaiian Islands (NWHI) in their natural character. The sanctuary 
designation process is described in Section 304 of the NMSA and 
requires the preparation of an environmental impact statement.


Alternatives:


The NMSP is considering seven alternatives. The first alternative 
(Status Quo/No Action Alternative) maintains the NWHI Research and E.O. 
provisions as is. It assumes a sanctuary will not be designated. This 
places caps on all fishing activities that were active at the time the 
E.O. was issued, and prohibits the development of new or inactive 
fisheries. This alternative makes provisions for several types of 
commercial and recreational fishing including bottomfishing/pelagic 
trolling, commercial trolling, sustenance fishing, and Native Hawaiian 
cultural and subsistence use. The second alternative mirrors the 
provisions of E.O. 13178 and 13196 but assumes those provisions will 
become regulations promulgated under the NMSA. In addition, this 
alternative provides straight-line boundaries, as opposed to fathom 
boundaries, to define Reserve/Sanctuary Preservation Areas to aid in 
user compliance and enforcement. Fishing regulations would be 
promulgated that would prohibit precious coral and crustacean harvest, 
but provide for bottomfish/pelagic trolling, commercial pelagic 
trolling, various forms of recreational fishing, and Native Hawaiian 
cultural and subsistence uses. The third alternative was developed by 
the Western Pacific Fishery Management Council and assumes that the 
Reserve would be designated as a national marine sanctuary, with 
fishing regulations promulgated under the NMSA. However, fishing 
activities would be managed in accordance with existing fishery 
management plans for those fishing activities currently practiced. This 
alternative also suggests that future harvest of precious corals and 
crustaceans would be managed under previously developed FMPs. However, 
in a Federal Register notice, NOAA issues a zero-harvest guideline and 
cited the E.O. as a reason to continue closure of the crustacean 
fishery.


The fourth alternative establishes a sanctuary with fishing regulations 
that would protect the highest ecosystem values while allowing 
compatible fishing activities in areas where they are likely to have 
less impact on the ecosystem. It prohibits precious coral and 
crustacean harvest, and pelagic

[[Page 64129]]

longlining, but provides for commercial bottomfish/pelagic trolling, 
commercial pelagic trolling, various forms of recreational fishing, and 
Native Hawaiian cultural and subsistence uses through a permitting 
process. The fifth alternative is an iteration of the fourth 
alternative and prohibits the same fishing activities. It also provides 
for bottomfish/pelagic trolling, commercial pelagic trolling, various 
forms of recreational fishing and Native Hawaiian cultural subsistence 
uses. The sixth alternative was developed by the Reserve Advisory 
Council and is similar to alternative 2 but would close bottomfish/
pelagic trolling within 1 year of sanctuary designation. It also calls 
for a zoning system to limit commercial and recreational pelagic 
fishing to minimize interactions with protected wildlife. The seventh 
alternative closes immediately the entire area to all extractive use, 
except for research or education.


Anticipated Cost and Benefits:


There are currently nine active commercial bottomfishermen in the NWHI, 
five in the Mau zone and four in the Ho'omalu zone. Total reported 2003 
gross revenue for the nine NWHI fishermen was just under $1.3 million 
with $611 thousand for the Mau zone and $674 thousand for the Ho'omalu 
zone. Total costs for 2003 were estimated at $974 thousand for the nine 
NWHI fishermen. The first alternative (Status Quo/No Action 
Alternative) would result in a 28 percent reduction in pounds landed 
for bottomfish/pelagic trolling catch, and 13 percent reduction for 
pelagic species compared to pre-E.O. levels based on full 
implementation of the E.O. The second alternative would result in a 28 
percent reduction in pounds landed for bottomfish/ pelagic trolling 
catch, and 13 percent reduction in the pelagic catch associated with 
bottomfishing, as compared to pre-E.O.. levels. The third alternative 
would result in a 0 percent reduction in pounds landed. The fourth 
alternative would reduce commercial bottomfish catch by 24 percent and 
pelagic landings by 13 percent. The fifth alternative would reduce 
bottomfish catch by 62 percent and pelagic catch by 10 percent due to 
the phase-out of bottomfishing for the Ho'omalu zone. The sixth 
alternative contemplates the complete phase-out of this industry within 
one year and would impact the industry by 100 percent. The seventh 
alternative would close the entire region to extractive use and would 
impact the industry by 100 percent.


Risks:


The establishment of the NWHI as a national marine sanctuary would 
protect one of the world's most productive and biologically rich 
ecosystems on Earth. The NWHI are among the few, large-scale, intact, 
predator-dominated coral reef ecosystems left in the world. Significant 
Native Hawaiian cultural and maritime historical resources are found 
throughout the region. These vast and remote coral reef ecosystems 
support a distinctive assemblage of marine mammals, fish, sea turtles, 
birds, and invertebrate, including species that are endemic, rare, 
threatened, or endangered. Federally protected species include the 
endangered Hawaiian monk seal. Roughly one-quarter of the 7,000 species 
found in the NWHI are believed to be endemic to the Hawaiian Island 
chain, found nowhere else on Earth.


Almost all of the alternatives would continue to allow some level of 
human activity in the area, including fishing. Research, monitoring and 
education activities would also be allowed pursuant to a permit system. 
There would, therefore, be risks to human safety associated with 
fishing and other vessels operating in remote areas of the Hawaiian 
Islands. At times, vessels could be exposed to potentially serious 
weather and sea conditions that could result in loss of life or injury 
as well as loss of property. In addition, risks to the environment 
could result from vessel groundings, lost fishing gear and other 
equipment, fuel spills, unauthorized discharges including sewage, etc. 
Depending on location, any of these incidents could harm or destroy 
fragile coral reefs or marine life.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            02/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, Local, State


Federalism:


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


Agency Contact:
Aulani Wilhelm
Acting Superintendent
Department of Commerce
National Oceanic and Atmospheric Administration
6700 Kalaniana' Ole Highway
Honolulu, HI 96825
Phone: 808 397-2657
Email: [email protected]
RIN: 0648-AS83
_______________________________________________________________________



DOC--NOAA

                              -----------

                            FINAL RULE STAGE

                              -----------




29. FISHERIES OF THE UNITED STATES; NATIONAL STANDARD 1

Priority:


Other Significant


Legal Authority:


16 USC 1801 et seq


CFR Citation:


50 CFR 600


Legal Deadline:


None


Abstract:


NMFS is considering revisions to the national standard guidelines for 
national standard 1 that specify criteria for determining overfishing 
and establishing rebuilding schedules. There have been concerns 
expressed by the scientific community, fisheries managers, the fishing 
industry, and environmental groups regarding the appropriateness of 
some aspects of these guidelines.


Statement of Need:


The overall intent of the Magnuson-Stevens Fishery Conservation and 
Management Act (Magnuson-Stevens Act) is to achieve optimum yield, 
prevent overfishing and rebuild overfished stocks in as short a time as 
possible. The National Marine Fisheries Service (NMFS) and the Regional 
Fishery Management Councils (Councils) are charged with the difficult, 
but important task of balancing the need to prevent overfishing and 
rebuild overfished stocks in as short a time as possible, taking into 
account the needs of fishing communities and fishing industry 
infrastructure, and evaluating actions in terms of overall benefits to 
the nation.


NMFS, the Councils, the public, and various stakeholders in fisheries 
in the

[[Page 64130]]

Exclusive Economic Zone (EEZ) have worked with the current version of 
the National Standards 1 (NS1) guidelines since June 1998, while 
developing overfishing definitions and rebuilding plans for various 
fisheries. Through this experience, NMFS has developed new perspectives 
about the utility of the current NS1 guidelines.


NMFS decided in November 2003, after receiving public comment on the 
current usefulness of the NS1 guidelines, and convening a NMFS Working 
Group (Working Group) to review the guidelines, that it would propose 
revisions to the guidelines. NMFS believes that the proposed revisions 
would improve the ability of the Councils to establish meaningful 
status determination criteria (SDC) and rebuilding plans that 
facilitate compliance with the Magnuson-Stevens Act.


Summary of Legal Basis:


The Magnuson-Stevens Act serves as the chief authority for fisheries 
management in the U.S. Exclusive Economic Zone. Section 301(a) of the 
Magnuson-Stevens Act contains 10 national standards with which all FMPs 
and their amendments must be consistent. Section 301(b) of the 
Magnuson-Stevens Act requires that ``the Secretary establish advisory 
guidelines (which shall not have the force and effect of law), based on 
the national standards, to assist in the development of fishery 
management plans.'' Guidelines for the national standards are codified 
in Subpart D of 50 CFR part 600. The guidelines for the national 
standards were last revised through a final rule published in the 
Federal Register on May 1, 1998 (63 FR 24212), by adding revisions to 
the guidelines for National Standards 1 (OY), 2 (scientific 
information), 4 (allocations), 5 (efficiency), and 7 (costs and 
benefits), and adding new guidelines for National Standards 8 
(communities), 9 (bycatch), and 10 (safety of life at sea).


The guidelines for NS1 were revised extensively in the final rule 
published on May 1, 1998, to bring them into conformance to revisions 
to the Magnuson-Stevens Act, as amended in 1996 by the Sustainable 
Fisheries Act (SFA). In particular, the 1998 revisions to the NS1 
guidelines addressed new requirements for FMPs brought about by SFA 
amendments to section 304(e) (rebuilding overfished fisheries).


Alternatives:


If the proposed revisions to terminology are adopted, NMFS would 
request that Regional Fishery Management Councils (Councils) begin 
using the new terms in place of the old terms, revise FMP language 
related to the revised terminology the next time a Council submits an 
FMP amendment for Secretarial review. NMFS would begin using the new 
terms in its next Annual Report to Congress of the Status of U.S. 
Fisheries. Any codified language existing under 50 CFR Part 600 for 
fisheries managed under the Magnuson-Stevens Act related to 
``overfished'', ``minimum stock size threshold'', and ``maximum fishing 
mortality threshold,'' would be revised by NMFS.


For the proposed revisions to the NS1 guidelines other than 
terminology, the new guidelines would apply to some, but not all new 
actions submitted by a Council. Any new action, that includes new or 
revised SDC (``depleted'' or ``overfishing'' definitions), OY control 
rules or rebuilding plans, would need to be developed and evaluated 
according to the revised NS1 guidelines. However, if a Council action 
containing SDC, OY control rules or rebuilding plans is already under 
development and a draft environmental impact statement's (DEIS) notice 
of availability has already been published in the Federal Register, 
before the final rule implementing the revised NS1 guidelines is 
effective, then a Council could submit an FMP or FMP amendment under 
either the ``old'' or ``new'' NS1 guidelines. Likewise, if the public 
hearing draft of an FMP amendment or other regulatory action not 
containing an EIS has already been adopted by a Council for public 
hearing, before the final rule implementing the revised NS1 guidelines 
is effective, then a Council could submit an FMP or FMP amendment under 
either the ``old'' or ``new'' NS1 guidelines.


After any final rule implementing the revisions to the NS1 guidelines 
becomes effective, if a Council submits an action (e.g., annual 
specifications, an FMP amendment, interim rulemaking, or a regulatory 
amendment) that does not involve new or revised SDC, OY control rules, 
or rebuilding plans, then that action could be reviewed and approved 
without the FMP being amended to bring existing SDC, OY control rules, 
and rebuilding plans into conformance with the new guidelines. The 
proposed action would still need to be in conformance with all of the 
national standard guidelines to be approvable. Any FMP amendment or 
other regulatory action that involves: (1) Proposed SDC, an OY control 
rule, or a rebuilding plan for a stock not previously managed by SDC or 
by a rebuilding plan; or (2) proposed revisions to SDC, an OY control 
rule, or a rebuilding plan for a stock already managed under SDC or by 
a rebuilding plan, then the proposed SDC, OY control rule, and/or 
rebuilding plan would need to comply with the new NS1 guidelines.


Regarding the proposed recommendation that stocks in FMPs be managed 
according to core stocks and stock assemblages, if a Council determines 
that a given FMP only has core stocks (e.g., the Mid-Atlantic Council's 
Spiny Dogfish FMP, the New England Council's Atlantic Sea Scallops FMP, 
the Deep-Sea Red Crab FMP, and the FMP for the Gulf of Mexico Stone 
Crab Fishery), then the Council should make such a determination with 
accompanying rationale in its next FMP amendment.


In the case of an FMP that has a mixture of SDC-known stocks and stocks 
having an ``unknown status'' related to SDC (e.g., Snapper-Grouper FMP) 
when a Council begins to align its management under ``core stocks'' and 
``stock assemblages,'' the Council could begin such alignment in a 
stepwise fashion (in a series of separate FMP actions) for given core 
stocks or stock assemblages, once new or revised SDC, OY control rules, 
or rebuilding plans are developed. If a Council determines that the 
stepwise method is problematic it could take action to realign all of 
the FMP's stocks into core stocks and stock assemblages in one action.


If some stocks are not being managed effectively under a given FMP 
because their status relative to SDC is unknown, and the proposed 
revisions to the NS1 guidelines are approved, then the Council should 
re-evaluate those stocks as soon as possible, to decide whether or not 
any grouping of some or all stocks having an unknown status could be 
managed by an SDC under one or more indicator stocks, or through stock 
assemblage-wide SDC. A Council should clearly designate which stocks in 
the FMP are in the FMPs and thus subject to SDC and to inclusion in the 
NMFS Annual Report to Congress on the Status of U.S. Fisheries. Stocks 
that are listed as threatened or endangered under the Endangered 
Species Act would be exempt from being evaluated according to SDC, but 
must be evaluated against SDC within 1 year of

[[Page 64131]]

being de-listed. Finally, stocks that are primarily dependent on 
artificial propagation from hatcheries would be exempt from being 
evaluated according to SDC. If any stocks are currently undergoing 
overfishing as part of an approved rebuilding plan (e.g., reductions in 
F are being phased in over a number of years until F is less than or 
equal to Film), then, the first time that the Council submits a revised 
rebuilding plan for those stocks, overfishing must be prevented, 
beginning in the first year of the revised rebuilding plan, except 
under circumstances listed under section 304(e)(4)(A) of the Magnuson-
Stevens Act.


In general, the Councils would not be required to amend their SDC, OY 
control rules and rebuilding plans approved under the SFA by any ``date 
certain,'' with the following exceptions. In the event that NMFS, on 
behalf of the Secretary of Commerce, determines that a fishery is 
overfished or approaching an overfished condition under section 
304(e)(1) or (e)(2) of the Magnuson-Stevens Act, or a rebuilding plan 
needs to be revised under section 304(e)(7) of the Magnuson-Stevens 
Act, then the Council needs to take action consistent with the revised 
NS1 guidelines. NMFS should notify the appropriate Council if 
overfishing is occurring in a fishery, even if the fish stock is not 
determined to be overfished, under the same procedures as described in 
Section 304(e) (1) and (2) of the Magnuson-Stevens Act.


If one or more stocks in an FMP do not currently have OY control rules, 
or the OY control rule equals its respective MY control rule, then the 
appropriate Council would need to develop and submit an FMP amendment 
or other appropriate regulatory action and analyses when the SDC or the 
rebuilding plan for such a fishery needs to be revised. Revisions are 
necessary when a stock's rebuilding plan is not making adequate 
progress under section 304(e)(7) of the Magnuson-Stevens Act, or new 
data or an assessment indicates that SDC or the rebuilding target needs 
revision. A Council can submit an OY control rule for Secretarial 
review before SDC or the rebuilding plan needs to be revised, if it 
chooses to do so.


Anticipated Cost and Benefits:


There will be no immediate economic or social impacts upon 
effectiveness of the final rule for the revised NS1 guidelines. 
Management actions that incorporate the new NS1 guidelines in their 
SDC, rebuilding plans would be evaluated individually and would not 
begin to have any economic or social impacts until about 1 1/2 to 2 
years after the effective date of this action.


Risks:


The National Marine Fisheries Service intends to clarify, amplify and 
simplify the NS1 guidelines in several instances so that the regional 
fishery management councils and the public have a better understanding 
of how to: (1) Establish definitions for ``depleted'' and 
``overfishing'' for fish stocks that vary in data quality, (2) 
construct and revise rebuilding plans, and (3) improve the ability of 
Councils and NMFS to comply with the requirements of section 304 of the 
Manson-Stevens Fishery Conservation and Management Act. The proposed 
revisions should improve the Councils' ability to protect stocks of 
unknown status (i.e., core stocks and stock assemblages provision), 
manage towards ending overfishing and rebuilding overfished stocks 
(i.e., biomass stock size limits, OY control rules, rebuilding targets, 
revision of rebuilding plans) and provide better clarity in the NS1 
guidelines. Improved conservation of various stocks should enhance the 
likelihood that optimum yield will be attained for those stocks, a 
chief goal of the Manson-Stevens Act.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           02/14/03                     68 FR 7492
ANPRM Comment Period End        03/17/03
Comment Period Extended         03/03/03                     68 FR 9967
NPRM                            06/22/05                    70 FR 36240
Comment Period Extended         08/15/05                    70 FR 47777
NPRM Comment Period End         08/22/05
Final Action                    10/00/05

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Mark Millikin
Fishery Management Specialist
Department of Commerce
National Oceanic and Atmospheric Administration
1315 East-West Highway
Silver Spring, MD 20910
Phone: 301 713-2341
RIN: 0648-AQ63
BILLING CODE 3510-BW-S

[[Page 64132]]




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 11 DoD field 
activities. It has over 1,390,000 military personnel and 675,000 
civilians assigned as of June 30, 2005, 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 affected 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 seldom issues significant regulations, the probability of 
developing conflicting regulations is low. Conversely, DoD is affected 
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 64133]]

 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'' The Department is actively participating in the 
eRulemaking Initiative to develop a government-wide docket management 
system that will provide the framework for wider citizen input and 
improve regulatory policies and outcomes by cultivating public 
participation in Federal decision-making.
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
 Defense Federal Acquisition Regulation Supplement (DFARS) Case 2003-
D107, Firefighting Service Contracts, implements Section 331 of the 
National Defense Authorization Act for Fiscal Year 2004. Section 331 
provides authority for contractor performance of firefighting functions 
at military installations or facilities for periods of one year or 
less, if the functions would otherwise have to be performed by members 
of the Armed Forces who are not readily available by reason of a 
deployment. The final rule was published in the Federal Register on 
December 15, 2004 (69 FR 75000).
 Defense Federal Acquisition Regulation Supplement (DFARS) Case 2004-
D032, Contractor Performance of Security Guard Functions, conditionally 
extends from December 1, 2005 to September 30, 2006, authority for 
contractor performance of security-guard functions at military 
installations

[[Page 64134]]

or facilities to meet the increased need for such functions since 
September 11, 2001. It implements Section 324 of the National Defense 
Authorization Act for Fiscal Year 2005, which requires DoD to submit a 
report to Congress on the use of this authority, no later than December 
1, 2005, to permit extension of the authority. The final rule was 
published in the Federal Register on March 23, 2005 (70 FR 14576).
 Federal Acquisition Regulation (FAR) Case 2003-022, Special Emergency 
Procurement Authority, implements Section 1443 of the Fiscal Year 2004 
Consolidated Appropriations Act and also incorporates the higher 
thresholds authorized by Section 822 of the Ronald W. Reagan National 
Defense Authorization Act for Fiscal Year 2005. This rule provides 
continuing authorities for acquisitions of property and services by or 
for an executive agency that are to be used in support of a contingency 
operation or to facilitate defense against or recovery from terrorism 
or nuclear, biological, chemical, or radiological attack. The final 
rule was published in the Federal Registeron December 20, 2004 (69 FR 
8312).
Regulations of Particular Interest to Small Business
The Department will work to clarify in the FAR that prime contractors 
must confirm HUBZone certification and permit small business credit for 
subcontracts awarded to certain Alaska Native Corporations and Indian 
tribes.
Suggestions From the Public for Reform Status of DoD Items
Rulemaking Actions in Response to Public Nominations
The Army Corps of Engineers has not undertaken any rulemaking actions 
in response to the public nominations submitted to the Office of 
Management and Budget in 2001, 2002, or 2004. Those nominations were 
discussed in Making Sense of Regulation: 2001 Report to Congress on the 
Costs and Benefits of Regulations and Unfunded Mandates on State, 
Local, and Tribal Entities, Stimulating Smarter Regulation: 2002 Report 
to Congress on the Costs and Benefits of Regulations and Unfunded 
Mandates on State, Local, and Tribal Entities, and Progress in 
Regulatory Reform: 2004 Report to Congress on the Costs and Benefits of 
Federal Regulations and Unfunded Mandates on State, Local, and Tribal 
Entities.
Specific Priorities
 For this regulatory plan, there are five specific DoD priorities, all 
of which reflect the established regulatory principles. 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 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, installations and the environment, health affairs, and the 
Defense personnel system.
U.S. Army Corps of Engineers, Directorate of Civil Works
Compensatory Mitigation in the Army Regulatory Program
Section 314 of the National Defense Authorization Act for Fiscal Year 
2004 (Public Law 108-136) requires the Secretary of the Army, acting 
through the Chief of Engineers, to issue regulations that establish 
performance standards and criteria for the use of compensatory 
mitigation for wetland functions lost as a result of activities 
authorized by Department of the Army (DA) permits. The statute also 
requires the regulation to contain provisions for the application of 
equivalent standards and criteria to each type of compensatory 
mitigation. The statutory deadline for publishing the final regulation 
is November 24, 2005.
The proposed regulation will be developed by considering concepts in 
current Federal compensatory mitigation guidance documents, and 
updating and modifying those concepts to improve compensatory 
mitigation decision-making and processes. We believe that the proposed 
regulation should take a watershed approach to compensatory mitigation 
for permitted impacts to wetlands, streams, and other aquatic 
resources. Although the statute refers only to wetlands, we believe 
that the regulation should be broader in scope, and address 
compensatory mitigation requirements for impacts to other aquatic 
resources, such as streams, in addition to wetlands.
Army Regulatory Program's Compliance with the National Historic 
Preservation Act
In 1990, 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 substantial changes in policy, and the NHPA was 
amended in 1992, leading to the publication in December 2000 of new 
implementing regulations at 36 CFR part 800, issued by the Advisory 
Council on Historic Preservation. Those regulations were amended on 
July 6, 2004. The Advisory Council on Historic Preservation's 
regulations allow Federal agencies to utilize alternate procedures in 
lieu of the regulations at 36 CFR part 800. To solicit public comment 
on the appropriate mechanism for revising the Army Regulatory Program's 
process for considering effects to historic properties resulting from 
activities authorized by DA permits, the Army Corps of Engineers 
published an Advance Notice of Proposed Rulemaking (ANPRM) to obtain 
the views of interested parties. After reviewing the comments received 
in response to the ANPRM, the Army Corps of Engineers will hold 
facilitated stakeholder meetings to determine the best course of action 
for revising its procedures to comply with the requirements of Section 
106 of the National Historic Preservation Act.
Defense Procurement and Acquisition
 The Department continues its efforts to reengineer its acquisition 
system to achieve its vision of an acquisition system that is 
recognized as being the smartest, most efficient, most responsive buyer 
of best value goods and services, which meet the warfighter's needs 
from a globally competitive base. To achieve this vision, the 
Department will focus in the acquisition regulations during this next 
year on implementing and institutionalizing initiatives that may 
include additional changes to existing and recently modified 
regulations to ensure that we are achieving the outcomes we desire 
(continuous process improvement).
 The Department of Defense continuously reviews its supplement to the 
Federal Acquisition Regulation (FAR) and continues to lead Government 
efforts to simplify the acquisition process to:
 Transform the Defense Federal Acquisition Regulation 
            Supplement (DFARS) to improve the efficiency and 
            effectiveness of the acquisition

[[Page 64135]]

            process, while allowing the acquisition workforce 
            flexibility to innovate. The transformed DFARS will contain 
            only requirements of law, DoD-wide policies, delegations of 
            FAR authorities, deviations from FAR requirements, and 
            policies/procedures that have a significant effect beyond 
            the internal operating procedures of DoD or a significant 
            cost or administrative impact on contractors or offerors.
 Revise the uniform treatment of contractor personnel who are 
            authorized to accompany the U.S. Armed Forces deployed 
            outside the United States in contingency operations, 
            humanitarian or peacekeeping operations, other military 
            operations, or training exercises designated by the 
            combatant commander, to implement the new DoD Instruction, 
            and require training for contractor personnel who interact 
            with detainees.
 Also coordinate with a representative of the Department of 
            State to provide a FAR rule to address uniform treatment of 
            other contractor personnel who are performing outside the 
            United States in a theater of operations during contingency 
            operations; humanitarian or peacekeeping operations; other 
            military operations; or military exercises designated by 
            the combatant commander; or at a diplomatic or consular 
            mission, when designated by the chief of mission.
 Implement new Free Trade Agreements with Morocco and Dominican 
            Republic-Central American FTA countries in the FAR and 
            DFARS, as well as increased thresholds for all trade 
            agreements.
 Phase in DFARS requirements for contractors to affix radio 
            frequency identification (RFID) tags to the exterior 
            packaging of items delivered under DoD contracts. This 
            practice will improve visibility of DoD assets in the 
            supply chain, increase the accuracy of shipment and receipt 
            data, and reduce the amount of time it takes to deliver 
            material to the warfighter.
 Require DoD contractors to provide Item Unique Identification 
            (IUID) data electronically in the IUID Registry for all DoD 
            personal property in possession of the contractor, in lieu 
            of annual reporting of Government property.
 Improve debt collection by evaluating existing FAR controls 
            and procedures for ensuring contract debts are identified 
            and recovered in a timely manner, properly accounted for in 
            each agencies' books and records, and properly coordinated 
            with the appropriate Government officials.
 Implement in the DFARS the statutory requirement that provides 
            for up to 100 percent levy against contract payments for 
            taxes owed by contractors, with consideration given to 
            national security implications.
 Add the process of validating a central Contractor 
            Registration registrant's taxpayer identification number 
            (TIN) with the Internal Revenue Service to improve data 
            accuracy in the Federal Procurement Data System.
 Permit use of a time-and-materials contract or a labor-hour 
            contract for a procurement of certain commercial services.
 Ensure that IT security requirements are included in all 
            relevant Government contracts. Require Federal agencies to 
            acquire only approved products and services for a complete 
            category of Authentication Services, which includes 
            electronic authentication for browser-based access, Federal 
            identity credentials for electronic and physical 
            authentication, and Public Key Infrastructure services.
 Establish consistent procedures for protecting sensitive 
            information from unauthorized use or disclosure, when the 
            performance of support service contracts requires the prime 
            contractor to have access to the sensitive information of 
            other contractors.
 Adjust acquisition-related thresholds in the FAR and DFARS for 
            inflation (except Davis-Bacon Act, Service Contract Act, 
            and trade agreements).
 Finalize the rewrite of FAR Part 27, Patents, Data and 
            Copyrights, to clarify, streamline, and update guidance and 
            clauses on patents, data, and copyrights.
 Provide FAR guidance on acceptability of photocopies of powers 
            of attorney for bid bonds and allow treatment of questions 
            regarding the authenticity and enforceability of the power 
            of attorney at the time of bid opening as a matter of 
            responsibility.
 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.
 Implement Earned Value Management in the FAR.
 Revise the FAR Part 45, Government Property, to organize and 
            streamline the management of Government property.
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.
Revitalizing Base Closure Communities and Addressing Impacts of 
Realignment
 The Department of Defense, in order to promote an efficient and 
successful base closure and realignment implementation process, has 
submitted proposed changes to its existing regulations in 32 CFR parts 
174, 175, and 176. These proposed changes would bring the regulations 
up-to-date with statutory requirements enacted after the 1995 round of 
base closures. The changes will also address changes in Departmental 
policy. The proposed rule making was published in the Federal Register 
for public comment August 9, 2005.
Restoration Advisory Boards
The requirement for the establishment of Restoration Advisory Board 
(RABs) is grounded in Section 324(a) of Public Law 104-106, which 
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 should not be a precondition to the 
establishment of RABs (amended title 10 section 2705(d)(2)(B)). In 
August 1996, the Department proposed and requested public comments on 
regulations regarding the characteristics, composition, funding, and 
establishment of RABs. These regulations were not finalized.

[[Page 64136]]

As a consequence of litigation in 2001, the Department substantially 
revised the regulations and shared a draft rule with RAB community 
members as part of the Department's outreach to affected members of the 
public. On March 26, 2003, OMB reviewed the draft proposed rule and 
agreed that it is not a ``significant regulatory action'' under EO 
12866. The Department published the proposed rule in Federal Register 
January 28, 2005. The proposed rule addressed scope, characteristics, 
composition, funding, establishment, operation and adjournment. The 
public comment period ended on March 29, 2005. The Department received 
a total of 219 comments from 29 individuals and organizations. We are 
now preparing a draft final rule that will address the comments. No 
significant changes are being made to the draft final RAB Rule. The 
Department plans to publish the final rule in fiscal year 2006.
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. DoD is directed to issue a final protocol to be 
applied to defense sites listed in the Department's munitions response 
site inventory.
The Department met with State and tribal representatives and also 
representatives of other federal agencies during preparation of the 
proposed rule published on August 22, 2003. The Department reviewed and 
incorporated comments from the sixteen sets of comments received during 
the public comment period that ended on November 19, 2003. The draft 
final rule is under review within the Department, which plans to 
publish the final rule in fiscal year 2006.
Most of the changes pertain to clarification of terms and definitions 
based on comments received or new statutory definitions promulgated in 
the National Defense Authorization Act for 2004 and codified at 10 
U.S.C. Section 101. The most significant change to the proposed rule 
pertains to the module that evaluates health hazards associated with 
munitions constituents and other chemical constituents. The Department 
also revised the rule to clarify that current landowners may 
participate in the application of the rule at Formerly Used Defense 
Sites and that the quality assurance panel that reviews each priority 
score will consist only of Department personnel.
Health Affairs, Department of Defense
The Department of Defense is able to meet its dual mission of wartime 
readiness and peacetime health care by operating an extensive network 
of medical treatment facilities. This network includes DoD's own 
military treatment facilities supplemented by civilian healthcare 
providers, facilities, and services under contract to DoD through the 
TRICARE program. TRICARE is a major healthcare initiative designed to 
improve the management and integration of DoD's healthcare delivery 
system. The program's goal is to increase access to healthcare 
services, improve healthcare quality, and control healthcare costs.
The TRICARE Management Activity plans to submit an interim final rule 
that prescribes double coverage payment procedures and makes revisions 
to TRICARE rules to accommodate beneficiaries who are eligible under 
both Medicare and TRICARE, and who participate in Medicare's outpatient 
prescription drug program under Medicare Part D. These revisions are 
mandated by the requirements contained in the CMS final rule for the 
Medicare Prescription Drug Benefit, Part D Plans with Other 
Prescription Drug Coverage, and the mandated effective date of January 
1, 2006, for the Medicare Prescription Drug Benefit. This interim final 
rule outlines procedures whereby TRICARE becomes second payer for 
Medicare Part D enrollees. The rule also establishes requirements and 
procedures for implementation of improvements to the TRICARE Pharmacy 
Benefits Program regarding the Uniform Formulary process, as directed 
by Section 714 of the NDAA for FY05. The economic impact of this 
interim final rule is estimated to be less than $100 million. It is 
anticipated that the final rule will be published by February 1, 2006.
National Security Personnel System
The National Defense Authorization Act for Fiscal Year 2004 (PL 108-
136, November 24, 2003) provided the Department of Defense (DoD) the 
authority to establish a more flexible civilian personnel management 
system. The National Security Personnel System (NSPS) will allow the 
Department to be a more competitive and progressive employer at a time 
when the country's national security demands a highly responsive system 
of civilian personnel management.
NSPS will establish new rules for how DoD civilians are hired, 
assigned, compensated, promoted, and disciplined. NSPS will also 
address the Department's labor relations and appeals processes. This 
will all be within the framework of merit principles, veterans' 
preference, and employees' rights to organize and bargain collectively. 
The goal of NSPS is to strengthen DoD's ability to accomplish its 
mission in an ever-changing defense environment.
In April 2004, the Department established a DoD Program Executive 
Office, National Security Personnel System (PEO-NSPS) to manage, 
oversee, and coordinate the development, design, and implementation of 
NSPS throughout the Department. This includes drafting (with OPM) 
regulations establishing NSPS.
Human Resources Management System
Section 9902(a) of Public Law 108-136 authorizes the Secretary of 
Defense and the Director of the Office of Personnel Management (OPM) to 
issue jointly prescribed regulations to establish a human resources 
management system for the Department of Defense. These regulations will 
provide for new rules and flexibilities in the areas of:
 Position classification and pay;
 Performance management (including a pay for performance 
            system, as required in section 9902(b)(6)(I) of Public Law 
            108-136);
 Hiring, assignment, and reduction in force.
Labor Management Relations System
Section 9902(m) of Public Law 108-136 authorizes the Secretary of 
Defense and the Director, OPM to establish a new labor management 
relations system for the Department, and allow for a collaborative, 
issue-based approach to labor management relations. Regulations 
developed jointly with OPM will provide a new framework for labor 
relations in DoD, with the goal of streamlined processes to allow for 
quicker and more efficient resolution of labor relations issues, while 
preserving collective bargaining rights for DoD employees.
Employee Appeals
Section 9902(h) of Public Law 108-136 provides the Secretary of Defense 
with authority to establish an appeals process in conjunction with NSPS 
to provide employees fair treatment in decisions relating to their 
employment.

[[Page 64137]]

The new appeals will be designed to streamline appeals procedures while 
ensuring that employees are afforded the protections of due process, as 
required by law.
NSPS Design Process and Timeline
The design of NSPS (which will result in regulations to be issued in 
the Federal Register) includes an extensive outreach effort to gather 
input and feedback from a variety of stakeholder groups, including DoD 
labor unions, employees, supervisors, managers, military commanders, 
and external groups such as veteran service organizations, (non-union) 
employee interest groups, and ``good-government'' groups. DoD working 
groups, comprised of DoD and OPM human resources experts, line 
managers, and system practitioners (e.g., legal, EEO) met in the late 
summer 2004 to identify and craft NSPS design options. In addition, DoD 
and OPM have met several times with DoD labor union representatives to 
gather input and discuss potential system designs.
After DoD and OPM senior leadership decided upon the NSPS design 
options, proposed regulations establishing and governing NSPS were 
published via the Federal Register for public comment. The Department 
issued proposed NSPS regulations on February 14, 2005. A 30-day public 
comment period ended on March 16, 2005; over 58,000 comments were 
received. Statutory procedures for collaborating with employee 
representatives on the content of the regulations, known as ``meet and 
confer,'' are provided in sections 9902(f) and 9902(m)(3). The meet and 
confer process began on April 18, 2005. The meet and confer process was 
extended beyond the minimum 30 days provided for in the statute. Based 
upon the comments received and the input from employee representatives, 
changes were made to the proposed regulations. The final regulations 
are expected to be published in fiscal year 2006. After a 30-day 
notification period to Congress, the regulations will become effective 
and the phased implementation of NSPS will begin.
National Security Personnel System-Hiring Authorities
The NSPS regulations will provide the authority for the Secretary of 
Defense, together with the Director of OPM, to establish new hiring 
authorities for the Department. Concurrent with the initial 
implementation of the system, the Department, jointly with OPM, intends 
to establish several new hiring authorities during the first and second 
quarters of fiscal year 2006. This will be accomplished, in accordance 
with the NSPS regulations, via a notice in the Federal Register.
BILLING CODE 5001-06-S

[[Page 64138]]




DEPARTMENT OF EDUCATION (ED)



Statement of Regulatory and Deregulatory Priorities
General
 We support States, local communities, institutions of higher 
education, and others in improving 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.
 We administer programs, grants, and loans that touch nearly every 
American at one point in their lives--approximately 14,000 public 
school districts, nearly 54 million students attending 93,000 
elementary and secondary schools, and almost 22 million postsecondary 
students. 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, local, and tribal governments, neighborhood 
groups, schools, colleges, rehabilitation service providers, 
professional associations, advocacy organizations, businesses, and 
labor organizations.
 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 necessary, we seek customer participation 
at all stages in the rulemaking process. We invite the public to submit 
comments on all proposed regulations through the Internet or by regular 
mail.
 We are continuing our efforts to streamline information collections, 
reduce burden on information providers involved in our programs, and 
make information maintained by us easily available to the public.
New Initiatives
 Among our new undertakings is bringing No Child Left Behind to the 
high school level. The President has called recent evidence of poor 
performance by America's high schools ``a warning and a call to 
action.'' The Administration's response is a comprehensive proposal 
that builds on the stronger accountability of No Child Left Behind to 
improve the quality of secondary education and ensure that every 
student not only graduates from high school, but, also, graduates 
prepared to enter college or the workforce with the skills to succeed. 
This initiative includes creation of several new programs and 
significant funding increases for existing programs that can have a 
major impact on secondary education. The actual appropriations will 
depend on congressional action. The appropriations may, in turn, result 
in additional regulatory activities by the Department.
 Another new initiative is the Teacher Incentive Fund, a program to 
develop and implement innovative ways--including performance-based 
compensation systems--to provide financial incentives for teachers and 
principals who raise student achievement and close the achievement gap 
in some of the Nation's highest-need schools.
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, which the Department approved. Each submitting 
jurisdiction has used its respective plan to hold schools and school 
districts accountable in school years 2002-03, 2003-04, and 2004-05 for 
the academic achievement of all their students, including students in 
specific subgroups such as students with disabilities and limited 
English proficient (LEP) students.
 With respect to students with disabilities and LEP students, in 
particular, the Department has initiated regulatory actions to address 
unique issues in the implementation of No Child Left Behind. Our 
current regulations permit a State to (1) develop alternate achievement 
standards for students with the most significant cognitive disabilities 
and (2) include those students' proficient and advanced scores in 
adequate yearly progress (AYP) determinations, subject to a cap of one 
percent of the number of students in a school district or State.
 We also published proposed regulations to permit a State to (1) exempt 
LEP students new to schools in the United States from one 
administration of the State's reading assessment and (2) include, for 
up to two years, former LEP students in the LEP subgroup when making 
AYP determinations.
 We are continuing to focus on helping States place a highly qualified 
teacher in every classroom; identifying schools and districts in need 
of improvement and making sure they are getting the assistance they 
need to get back on track; expanding the opportunities for eligible 
students to receive tutoring and other supplemental educational 
services; and helping districts create capacity in order to make public 
school choice available to all eligible students who wish to change 
schools.
 We are also peer-reviewing evidence of each State's standards and 
aligned assessment systems that implement No Child Left Behind's 
requirements for annual testing in reading/language arts and 
mathematics in grades 3 through 8 and once in high school. These new 
reading/language arts and mathematics standards and assessments must be 
in place by the end of the 2005-06 school year.
Regulatory and Deregulatory Priorities for the Next Year
 The Individuals with Disabilities Education Improvement Act of 2004 
(Pub. L. 108-446) made substantial changes to the Individuals with 
Disabilities Education Act (IDEA). These changes are designed to 
improve (1) implementation of the education of children with 
disabilities program (including preschool services) under part B and 
the early intervention program for infants and toddlers with 
disabilities under part C and (2) the effectiveness of national 
discretionary grants, contracts, and cooperative agreements for 
improving the education of children with disabilities under part D.
 Consistent with those statutory changes, the Department published a 
notice of proposed rulemaking (NPRM) on June 21, 2005 proposing 
revisions to 34 CFR Parts 300, 301, and 304 concerning the education of 
children with disabilities program (including

[[Page 64139]]

preschool services) under part B of IDEA and the service obligation 
under the personnel development to improve services for children with 
disabilities program under part D of IDEA. The Department held a series 
of public hearings on this NPRM in June and July 2005 and received 
public comment until September 6, 2005. We anticipate issuing final 
regulations before spring 2006.
 The Department also published, on June 29, 2005, an NPRM proposing to 
establish a National Instructional Materials Accessibility Standard, as 
directed by the reauthorized IDEA. We expect to issue final regulations 
on this standard in late fall 2005. Proposed regulations to implement 
changes to the part C program are expected to be issued in fall 2005, 
with final regulations issued some time in 2006.
 Under No Child Left Behind, we are working on developing a notice of 
proposed rulemaking that would provide further flexibility by 
permitting a State to develop modified achievement standards and 
assessments for some students with disabilities in addition to 
students, referenced elsewhere in this plan, with the most significant 
cognitive disabilities.
 Congress is developing legislation to amend and extend the Higher 
Education Act of 1965 (HEA). If enacted, changes to the regulations 
governing the grant, loan, and work assistance programs authorized 
under title IV of the HEA will be necessary in order to improve 
educational quality, expand access, and ensure affordability in 
postsecondary education. Any regulatory activity that becomes necessary 
as a result of amendments to the HEA would need to balance reduction in 
burden on program participants, especially on students, with the need 
to adequately safeguard taxpayers' funds. Unless the HEA is amended to 
remove the requirement, regulations governing HEA title IV programs 
will continue to be developed through negotiated rulemaking. The HEA 
also authorizes other important programs, and changes to regulations 
may be necessary to improve the implementation of the teacher-quality-
enhancement programs under title II, the institutional-assistance 
programs under titles III and V, the international and foreign language 
studies programs under title VI, and the graduate education and 
postsecondary education improvement programs under title VII. Under 
current law, these programs are not subject to negotiated rulemaking.
Other Potential Regulatory Activities
 Congress is developing legislation that would reauthorize a number of 
the Department's other major programs. Enactment of these legislative 
undertakings could result in various regulatory activities by the 
Department. These include reauthorization of the Carl D. Perkins 
Vocational and Technical Education Act of 1998, which would make 
changes designed to improve the State grant and other programs 
providing assistance under this statute and considered necessary to 
help States and local communities strengthen career and technical 
education and improve educational opportunities for career and 
technical education students. The Administration is working with 
Congress to ensure that this reauthorization emphasizes student 
achievement, particularly the academic achievement of career and 
technical education students, and increases accountability and program 
quality.
 Congress also is considering legislation to reauthorize the Adult 
Education and Family Literacy Act (AEFLA) (title II of the Workforce 
Investment Act of 1998)--including the National Institute for 
Literacy--and the Rehabilitation Act of 1973. The Administration is 
working with Congress to ensure that these changes improve and 
streamline the State grant and other programs providing assistance for 
adult basic education under the AEFLA and for vocational rehabilitation 
and independent living services for persons with disabilities under the 
Rehabilitation Act of 1973, and that they provide greater 
accountability in the administration of programs under both statutes.
Principles for Regulating
 Our Principles for Regulating determine when and how we will regulate. 
Through consistent application of the following principles, we have 
eliminated 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.
When regulating, we consider:
 Whether a regulation is essential to promote quality and 
            equality of opportunity in education.
 Whether a demonstrated problem cannot be resolved without 
            regulation.
 Whether a regulation is necessary to provide a legally binding 
            interpretation to resolve ambiguity.
 Whether entities or situations to be regulated are so diverse 
            that a uniform approach does more harm than good.
 How to regulate:
 Regulate no more than necessary.
 Minimize burden and promote multiple approaches to meeting 
            statutory requirements.
 Encourage federally funded activities to be integrated with 
            State and local reform activities.
 Ensure that benefits justify costs of regulation.
 Establish performance objectives rather than specify 
            compliance behavior.
 Encourage flexibility so institutional forces and incentives 
            achieve desired results.
_______________________________________________________________________



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

                              -----------

                            FINAL RULE STAGE

                              -----------




30.  ASSISTANCE TO STATES FOR THE EDUCATION OF CHILDREN WITH 
DISABILITIES; PRESCHOOL GRANTS FOR CHILDREN WITH DISABILITIES; AND 
SERVICE OBLIGATIONS UNDER SPECIAL EDUCATION--PERSONNEL DEVELOPMENT 
(SECTION 610 REVIEW)

Priority:


Other Significant


Legal Authority:


20 U.S.C. 1221e-3, 1406, 1411-1419, 1462(h)


CFR Citation:


34 CFR 300, 301 and 304


Legal Deadline:


None


Abstract:


These regulations would amend the regulations governing the Assistance 
to States for Education of Children with Disabilities Program, the 
Preschool Grants for Children With Disabilities Program, and Service 
Obligations under the Special Education Personnel Development to 
Improve Services and

[[Page 64140]]

Results for Children with Disabilities Program. These amendments are 
needed to implement changes to the Individuals with Disabilities 
Education Act made by the recently enacted Individuals with 
Disabilities Education Improvement Act of 2004.


Statement of Need:


These regulations are necessary to implement the reauthorized statute.


Summary of Legal Basis:


New legislation.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Notice                          01/10/02                     67 FR 1411
NPRM                            06/21/05                    70 FR 35781
NPRM Comment Period End         09/06/05
Final Action                    12/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Troy Justesen
Department of Education
Office of Special Education and Rehabilitative Services
400 Maryland Avenue SW
Room 5138, PCP
Washington, DC 20202-2570
Phone: 202 245-7468
Related RIN: Related to 1820-AB54
RIN: 1820-AB57
BILLING CODE 4000-01-S

[[Page 64141]]




DEPARTMENT OF ENERGY (DOE)



Statement of Regulatory and Deregulatory Priorities
 The Department of Energy (Department or DOE) makes vital contributions 
to the Nation's welfare through its activities focused on improving 
national security, energy supply, environmental remediation, and energy 
research. The Department's mission is to:
 Promote dependable, affordable and environmentally sound 
            production and distribution of energy;
 Foster energy conservation;
 Provide responsible stewardship of the Nation's nuclear 
            weapons;
 Clean up the Department's sites and facilities, which include 
            sites dating back to the Manhattan Project;
 Lead in the physical sciences and advance the biological, 
            environmental and computational sciences; and,
 Provide premiere instruments of science for the Nation's 
            research enterprise.
 The Department's regulatory activities are essential to achieving its 
critical mission and to implementing major initiatives of the 
President's National Energy Policy. Among other things, the Regulatory 
Plan and the Unified Agenda contain the rulemakings the Department will 
be engaged in during the coming year to implement provisions of the 
Energy Policy Act of 2005 (EPACT 2005). The Regulatory Plan and Unified 
Agenda also reflect the Department's continuing commitment to cut 
costs, reduce regulatory burden, and increase responsiveness to the 
public.
Energy Efficiency Program for Consumer Products and Commercial 
Equipment
EPACT 2005, enacted on August 8, 2005, will have a significant impact 
on the Department's priorities for its rulemaking activities related to 
energy efficiency standards, test procedures, and determinations. EPACT 
2005 not only adds new products to those already covered by the Energy 
Policy and Conservation Act (EPCA), but it also affects ongoing 
rulemakings.
With respect to those ongoing rulemakings, DOE has made it a priority 
to take action to clear up the backlog of regulatory action on energy 
efficiency standards and test procedures that are overdue under EPCA. 
As part of the Department's annual priority-setting process for its 
consumer products and commercial equipment rulemakings to be carried 
out under the Process Rule, 61 FR 36974 (July 15, 1996), interested 
members of the public will have an opportunity to give input to help 
the Department prioritize the rulemakings it will conduct. The 
Department will continue actions necessary to clear up the backlog of 
standards and test procedures covered by the EPCA, such as the 
standards for certain commercial equipment covered by amendments to 
American Society of Heating, Refrigerating and Air-Conditioning 
Engineers, Inc./Illuminating Engineering Society of North America 
Standard 90.1. Information and timetables concerning these actions can 
be found in the Department's Regulatory Agenda, which appears elsewhere 
in this issue of the Federal Register.
 EPACT 2005 adds both energy conservation standards and test procedure 
requirements to the program. The Department will incorporate the 
statutorily mandated and non-discretionary energy conservation 
standards of EPACT 2005 into the Department's regulations before the 
end of 2005. Included among these are standards for commercial central 
air conditioners and central air conditioning heat pumps. Consistent 
with EPACT 2005, the Department intends to continue its work on 
adoption of amended energy efficiency standards for residential 
furnaces and boilers and on new standards for electric distribution 
transformers.
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 June 2006. In addition, by the end of March 2006, the Department is 
scheduled to issue a final rule adding a new part, 10 CFR 851, Worker 
Safety and Health, that will establish basic requirements to ensure 
workers are protected from safety and health hazards at DOE facilities.
Strategic Petroleum Reserve Acquisition Procedures
The Department is committed to maintaining the Strategic Petroleum 
Reserve as a cornerstone of U.S. energy security policy to protect 
against the damaging effects of a severe energy supply interruption. 
The Department's recent use of the Reserve to loan oil to companies 
adversely affected by Hurricane Katrina, and particularly the 
President's authorization to draw down and sell oil from the Reserve in 
response to that hurricane, demonstrated both the importance of the 
Reserve to national security and the excellent operating condition in 
which DOE has maintained the Reserve.
 The Department will continue to work to ensure that sufficient Reserve 
inventory levels are maintained to provide the appropriate degree of 
security. Consistent with this goal and as required by EPACT 2005, the 
Department will be proposing in November 2005 procedures for the 
acquisition of petroleum to fill the Reserve to its authorized one 
billion barrel capacity. The procedures must take into account a number 
of factors including the need to maximize availability of domestic 
petroleum supply while minimizing costs and adverse impacts on current 
and future prices, supplies and inventories. In addition, the 
procedures must include criteria for reviewing requests for the 
deferral of scheduled deliveries. As directed by EPACT 2005, the 
Department intends to publish final procedures in February 2006.
Standby Support
 EPACT 2005 authorizes the Secretary to enter into contracts for 
standby support for advanced nuclear power facilities for certain 
unexpected delays. These delays include those caused by failure of the 
Nuclear Regulatory Commission to comply with schedules for review and 
approval of inspection, tests, analyses, and acceptance criteria 
established under the combined Construction Permit and Operating 
License process, as well as delays caused by litigation of the 
commencement of full-power operations of an advanced nuclear facility. 
The

[[Page 64142]]

Department is committed to openness and public participation as it 
develops rules and criteria for standby support and promptly will be 
taking action to promulgate such rules.
_______________________________________________________________________



DOE--Energy Efficiency and Renewable Energy (EE)

                              -----------

                             PRERULE STAGE

                              -----------




31.  RULEMAKING TO DETERMINE WHETHER THE ENERGY CONSERVATION 
STANDARDS FOR RESIDENTIAL CENTRAL AIR CONDITIONERS AND AIR CONDITIONING 
HEAT PUMPS SHOULD BE AMENDED

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 6295(d)


CFR Citation:


10 CFR 430


Legal Deadline:


Final, Statutory, January 1, 2001, Overdue for review of whether 
amended standard is justified.


Abstract:


The Department is committed to becoming current on all energy standards 
rulemakings, including whether the current standards for residential 
central air conditioners and central air conditioning heat pumps should 
be amended.


Statement of Need:


Standards need to be periodically reviewed and updated, as required by 
EPCA, to reflect technological advances that make amended energy 
efficiency standards technologically feasible and economically 
justified.


Alternatives:


Congress has the ability to prescribe amended standards, as it did for 
some consumer products and industrial equipment through EPACT 2005, 
rather than DOE conducting rulemakings to determine whether amended 
standards are appropriate.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                              To Be                     Determined

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Local, State


Federalism:


 Undetermined


Additional Information:


The timetable for this action will be determined during the annual 
priority-setting of rulemakings.


Agency Contact:
Bryan Berringer, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0371
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AB47
_______________________________________________________________________



DOE--EE



32.  RULEMAKING TO DETERMINE WHETHER THE ENERGY CONSERVATION 
STANDARDS FOR RESIDENTIAL WATER HEATERS SHOULD BE AMENDED

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 6295(e)


CFR Citation:


10 CFR 430


Legal Deadline:


Final, Statutory, January 1, 2000, Overdue for review of whether 
amended standard is justified.


Abstract:


The Department is committed to becoming current on all energy standards 
rulemakings, including whether the current standards for residential 
water heaters should be amended.


Statement of Need:


Standards need to be periodically reviewed and updated, as required by 
EPCA, to reflect technological advances that make amended energy 
efficiency standards technologically feasible and economically 
justified.


Alternatives:


Congress has the ability to prescribe amended standards, as it did for 
some consumer products and industrial equipment through EPACT 2005, 
rather than DOE conducting rulemakings to determine whether amended 
standards are appropriate


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                              To Be                     Determined

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Local, State


Federalism:


 Undetermined


Additional Information:


The timetable for this action will be determined during the annual 
priority-setting of rulemakings.


Agency Contact:
Bryan Berringer, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0371
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AB48
_______________________________________________________________________



DOE--EE



33.  RULEMAKING TO DETERMINE WHETHER THE ENERGY CONSERVATION 
STANDARDS FOR ELECTRIC AND GAS RANGES AND OVENS, AND FOR MICROWAVE 
OVENS SHOULD BE AMENDED

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 6295(h)


CFR Citation:


10 CFR 430


Legal Deadline:


Final, Statutory, January 1, 1997, Overdue for review of whether 
amended standard is justified.

[[Page 64143]]

Abstract:


The Department is committed to becoming current on all energy standards 
rulemakings, including whether the current standards for electric and 
gas ranges and ovens and microwave ovens should be amended.


Statement of Need:


The Department may determine that separate rulemakings may be warranted 
for some of these individual products or equipment. The timetable for 
this action will be determined during the annual priority-setting of 
rulemakings


Alternatives:


Congress has the ability to prescribe amended standards, as it did for 
some consumer products and industrial equipment through EPACT 2005, 
rather than DOE conducting rulemakings to determine whether amended 
standards are appropriate


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                              To Be                     Determined

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Local, State


Federalism:


 Undetermined


Additional Information:


The timetable for this action will be determined during the annual 
priority-setting of rulemakings.


Agency Contact:
Bryan Berringer, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0371
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AB49
_______________________________________________________________________



DOE--EE



34.  RULEMAKING TO DETERMINE WHETHER THE ENERGY CONSERVATION 
STANDARDS FOR FLUORESCENT LAMP BALLASTS SHOULD BE AMENDED

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 6295(g)


CFR Citation:


10 CFR 430


Legal Deadline:


Final, Statutory, January 1, 2006.


Abstract:


This rulemaking is to determine whether the current standards for 
fluorescent lamp ballasts should be amended.


Statement of Need:


Standards need to be periodically reviewed and updated, as required by 
EPCA, to reflect technological advances that make amended energy 
efficiency standards technologically feasible and economically 
justified.


Alternatives:


Congress has the ability to prescribe amended standards, as it did for 
some consumer products and industrial equipment through EPACT 2005, 
rather than DOE conducting rulemakings to determine whether amended 
standards are appropriate.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                              To Be                     Determined

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Local, State


Federalism:


 Undetermined


Additional Information:


The timetable for this action will be determined during the annual 
priority-setting of rulemakings.


Agency Contact:
Bryan Berringer, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0371
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AB50
_______________________________________________________________________



DOE--EE



35.  RULEMAKING TO DETERMINE WHETHER THE ENERGY CONSERVATION 
STANDARDS FOR ROOM AIR CONDITIONERS SHOULD BE AMENDED

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 6295(c)


CFR Citation:


10 CFR 430


Legal Deadline:


Final, Statutory, September 24, 2002, Overdue for review of whether 
amended standard is justified.


Abstract:


The Department is committed to becoming current on all energy standards 
rulemakings, including whether the current standards for room air 
conditioners should be amended.


Statement of Need:


Standards need to be periodically reviewed and updated, as required by 
EPCA, to reflect technological advances that make amended energy 
efficiency standards technologically feasible and economically 
justified.


Alternatives:


Congress has the ability to prescribe amended standards, as it did for 
some consumer products and industrial equipment through EPACT 2005, 
rather than DOE conducting rulemakings to determine whether amended 
standards are appropriate.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                              To Be                     Determined

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Local, State


Federalism:


 Undetermined


Additional Information:


The timetable for this action will be determined during the annual 
priority-setting of rulemakings.

[[Page 64144]]

Agency Contact:
Bryan Berringer, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0371
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AB51
_______________________________________________________________________



DOE--EE

                              -----------

                          PROPOSED RULE STAGE

                              -----------




36. ENERGY EFFICIENCY STANDARDS FOR RESIDENTIAL FURNACES AND BOILERS

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(f)


CFR Citation:


10 CFR 430


Legal Deadline:


Final, Statutory, January 1, 1994.


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 residential 
furnaces and boilers.


Statement of Need:


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. EPACT 2005 amended EPCA to authorize the 
Department to set standards for electricity used in furnaces to 
circulate air through duct work. Section 135(c)


Alternatives:


The statute requires the Department to conduct rulemakings to review 
standards and to revise standards to achieve the maximum improvement in 
energy efficiency that the Secretary determines is technologically 
feasible and economically justified. In making this determination, the 
Department conducts a thorough analysis of the alternative standard 
levels, including the existing standard, based on criteria specified by 
statute. The process improvements that were announced (61 FR 36974, 
July 15, 1996) further enhance the analysis of alternatives in the 
appliance standards development process. For example, under this 
process, the Department will ask stakeholders and private sector 
technical experts to review its analyses of the likely impacts, costs, 
and benefits of alternative standard levels. In addition, the 
Department will solicit and consider information on nonregulatory 
approaches for encouraging the purchase of energy efficient products.


Anticipated Cost and Benefits:


The specific costs and benefits for this rulemaking have not been 
established because the final standard levels have not been determined. 
Nevertheless, existing analysis from the Advance Notice of Proposed 
Rulemaking for energy conservation standards for furnace and boilers 
projects saving between 0.28 and 9.29 quadrillion Btus of energy from 
2012 to 2035, with a national financial impact on the consumer in terms 
of national Net Present Value (NPV) ranging from $0.1 to $3.2 billion. 
(69 FR 45420)


Risks:


At higher efficiency levels, consumers risk unintended condensation of 
flue gases, whereas, without changes to the existing furnace and boiler 
standards, energy use and energy costs for consumers will continue to 
increase. Enhancing appliance energy efficiency also 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                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           09/08/93                    58 FR 47326
Framework Workshop              07/17/01
Venting Workshop                05/08/02
ANPRM                           07/29/04                    69 FR 45419
DOE Review of Technical 
    Support Documents           08/11/05
Electricity Use Workshop        01/00/06
NPRM                            09/00/06
Final Action                    09/00/07

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Local, State


Additional Information:


DOE is planning a workshop on electricity use because section 135(c) of 
EPACT 2005 expanded DOE's authority to consider electricity used by 
furnaces for moving air through the ductwork. DOE may revise the 
timetable if the outcome of the workshop indicates that such revision 
is appropriate.


Agency Contact:
Mohammed Kahn, EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
Office of Building Technologies Program
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-7892
Email: [email protected]
RIN: 1904-AA78
_______________________________________________________________________



DOE--EE



37. ENERGY EFFICIENCY STANDARDS FOR ELECTRIC DISTRIBUTION TRANSFORMERS

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 6317(a)(2)


CFR Citation:


10 CFR 431

[[Page 64145]]

Legal Deadline:


Final, Statutory, October 24, 1996.


Abstract:


Prior to enactment of EPACT 2005, the Energy Policy and Conservation 
Act, as amended, (EPCA) did not establish energy efficiency standards 
for electric distribution transformers. EPCA directed DOE to determine 
whether standards for electric distribution transformers were 
warranted. However, as a result of amendments recently adopted in EPACT 
2005, Pub. L. No. 109-58, sec. 135(c)(4), EPCA now contains standards 
for low voltage dry-type electric distribution transformers, but not 
other types of distribution transformers. This rulemaking will 
determine whether it is appropriate to establish standards for these 
other types of electric distribution transformers. The Department will 
also incorporate into its regulations the standards recently 
incorporated into EPCA.


Statement of Need:


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 authorizes the Department to establish energy conservation 
standards for various consumer products and commercial and industrial 
equipment, including distribution transformers, if DOE determines that 
energy conservation standards would be technologically feasible and 
economically justified, and would result in significant energy savings. 
Title III of EPCA sets forth a variety of provisions designed to 
improve energy efficiency. Part C of Title III, 42 USC 6311-6317, 
establishes a program for ``Certain Industrial Equipment,'' similar to 
the one for consumer products in Part B, and includes distribution 
transformers. Since EPACT 2005, Pub. L. No 109-58, sec. 135(c), 
establishes energy conservation standards for one group of 
transformers, low-voltage, dry-type distribution transformers, that 
category will no longer be covered by this rulemaking.


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 July 15, 1996, 61 
FR 36974, 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 have not been 
established because the final standard levels have not been determined. 
Nevertheless, existing analysis from the Advance Notice of Proposed 
Rulemaking, 69 FR 45375, for energy conservation standards for 
distribution transformers projects savings of from 7 to 16 quadrillion 
Btus of energy from 2007 to 2035, with a national financial impact on 
the consumer in terms of national Net Present Value (NPV) ranging from 
4 to 12.77 billion dollars. .


Risks:


At higher efficiency levels, the limited availability of some core 
steels is an important issue. Other issues that pose some risks include 
significant capital investment requirements, core processing equipment, 
retooling, and R&D. Establishing standards that are too stringent could 
result in excessive increases in the cost of the product, with possible 
reductions in product utility (larger/bulkier/heavier transformers), 
with additional pressure on some manufacturers to move production out 
of the U.S. and a possible risk that some small manufacturers would 
exit.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Determination Notice            10/22/97                    62 FR 54809
ANPRM                           07/29/04                    69 FR 45375
DOE Review of Technical 
    Support Documents           08/11/05
NPRM                            09/00/06
Final Action                    09/00/07

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Additional Information:


The timetable for this action reflects program priorities, which were 
established with significant input from the public. The Department is 
also assessing how it should proceed to incorporate into its rules the 
standards prescribed in EPACT 2005 for low voltage dry-type electric 
distribution transformers.


Agency Contact:
Antonio Bouza, EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20676
Phone: 202 586-0854
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AB08
_______________________________________________________________________



DOE--Departmental and Others (ENDEP)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




38.  ACQUISITION OF PETROLEUM FOR STRATEGIC PETROLEUM RESERVE

Priority:


Other Significant. Major under 5 USC 801.


Legal Authority:


42 USC 6240


CFR Citation:


Not Yet Determined


Legal Deadline:


NPRM, Statutory, December 6, 2005.


Final, Statutory, February 6, 2006.


Abstract:


This action would establish procedures for the acquisition of petroleum 
to fill the Strategic Petroleum Reserve to the one billion barrel 
capacity authorized under Section 154(a) of the Energy Policy and 
Conservation Act. The procedures must include criteria for reviewing 
requests for deferral of scheduled deliveries.

[[Page 64146]]

Statement of Need:


The recently enacted Energy Policy Act of 2005 requires promulgation of 
these procedures. Procedures for filling strategic stocks must take 
into account the need to maximize availability of domestic petroleum 
supply while minimizing costs and adverse impacts on current and future 
prices, supplies and inventories


Summary of Legal Basis:


The Energy Policy and Conservation Act provides the Department with 
broad authority to acquire petroleum for the Reserve and sets broad 
objectives as to the manner in which such acquisition is made. The 
Energy Policy Act of 2005 amended the Energy Policy and Conservation 
Act to require the Department to develop, with public notice and 
opportunity to comment, and comply with procedures to acquire oil to 
fill the Strategic Petroleum Reserve. The proposed procedures shall 
address acquisition by various means, including purchase, transfer of 
royalty oil from the Department of the Interior and deferral of 
deliveries under contracted schedules. These governing objectives set 
forth in the Energy Policy and Conservation Act are the minimization of 
costs, vulnerability to a supply disruption, and impact on supply 
levels and market forces, while maximizing encouraging competition in 
the petroleum industry. While recent fill has utilized the receipt of 
royalties-in- kind from Federal offshore production and premium barrels 
generated through renegotiation of delivery schedules, proposed 
procedures will also address outright purchase of crude oil. DOE also 
may acquire oil, and may address in its procedures, country-to-country 
oil purchases, facility leases with payments in oil, contracts for oil 
not owned by the United States as provided for by section 171 of the 
Energy Policy and Conservation Act, and return of oil and associated 
in-kind premiums for withdrawals from the Reserve for oil exchanges


Alternatives:


The governing objectives for the procedures set forth in the Energy 
Policy and Conservation Act, are the minimization of costs, 
vulnerability to a supply disruption, and impact on supply levels and 
market forces, while encouraging competition in the petroleum industry. 
While recent fill has utilized the receipt of royalties-in- kind from 
Federal offshore production and premium barrels generated through 
renegotiation of delivery schedules, proposed procedures will also 
address outright purchase of crude oil. There are other circumstances 
during which the Department of Energy may acquire oil for the Strategic 
Petroleum Reserves.


Anticipated Cost and Benefits:


The specific costs and benefits for this rulemaking have not been 
established because of the uncertainty inherent in petroleum markets in 
general, the schedule of fill according to the development of strategic 
storage capacity and the timing of any drawdown in response to a supply 
disruption. However, several studies reinforce the value of a larger 
Reserve in mitigating the adverse economic impacts of a disruption, 
either through deterrence or supplemental supply. Additionally, global 
stockpiling is enhanced through example.


Risks:


This rulemaking may reduce the risk of adverse market price and supply 
impacts from filling the Reserve by providing transparency into 
acquisition procedures and assurances that the statutory objectives are 
met.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05
Final Action                    02/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Lynnette H LeMat
Director, Operations and Readiness, Office of Petroleum Reserves
Department of Energy
1000 Independence Avenue, SW
Washington, DC 20585-0340
Phone: 202 586-4398
Fax: 202 586-0835
Email: [email protected]
RIN: 1901-AB16
_______________________________________________________________________



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 include a dose 
limitation system for protection of the public; requirements for 
application optimization (As Low As is Reasonably Achievable, ALARA) 
process; 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.

[[Page 64147]]

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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/25/93                    58 FR 16268
Second NPRM                     08/31/95                    60 FR 45381
Integrate new EPA 
    guidance                    03/00/06
Final Action                    06/00/06

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal


Additional Information:


The Environmental Protection Agency (EPA) is considering revising the 
Federal Guidance for Radiation Protection of the Public. This 
Presidential-level guidance would refine the radiation protection and 
dose limitation framework for the public, and may include numerical 
Radiation Protection Goals (i.e., dose limits). Because it is DOE's 
policy to be consistent with Federal radiation protection policy, the 
Department is adjusting the schedule for part 834 in anticipation of 
revised Federal Guidance and will issue the rule following EPA action 
on the guidance. This will allow DOE to be consistent with the most 
current Presidential-level guidance upon its release.


Agency Contact:
Andrew Wallo III
Director, Office of Air, Water and Radiation Protection, Policy and 
Guidance
Department of Energy
Office of Environmental Guidance
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-4996
Fax: 202 586-3915
RIN: 1901-AA38
_______________________________________________________________________



DOE--ENDEP



40. WORKER SAFETY AND HEALTH

Priority:


Other Significant


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.


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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/08/03                    68 FR 68276
NPRM Comment Period End         02/06/04
NPRM Suspension                 02/27/04                     69 FR 9277
Supplemental NPRM               01/26/05                     70 FR 3811
Supplemental NPRM Comment 
    Period End                  04/26/05
Final Action                    03/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


A Notice of Suspension was issued on 02/27/2004 to allow time for the 
Department to consult with the Defense Nuclear Facilities Safety Board 
(DNFSB) in order to resolve its concerns.

[[Page 64148]]

Agency Contact:
Bill McArthur
Department of Energy
1000 Independence Avenue, SW.
Washington, DC 20585
Phone: 301 930-9674
RIN: 1901-AA99
_______________________________________________________________________



DOE--ENDEP



41.  STANDBY SUPPORT FOR ADVANCED NUCLEAR FACILITY DELAYS

Priority:


Other Significant


Unfunded Mandates:


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


Legal Authority:


PL 109-58, sec 638


CFR Citation:


Not Yet Determined


Legal Deadline:


Final, Statutory, August 8, 2005.


Other, Statutory, May 6, 2006, Interim Final Rule.


Abstract:


The Energy Policy Act of 2005 (EPACT 2005) authorizes the Secretary to 
provide standby support for sponsors of advanced nuclear power 
facilities for certain unexpected delays such as those caused by 
litigation or Nuclear Regulatory Commission (NRC) licensing problems 
that delay a facility from obtaining full power operation.


Statement of Need:


A number of nuclear power facilities built in the U.S. during the 
1970's and 1980's experienced long delays in obtaining authorization to 
operate at full power after completed and initial operating licenses 
were granted. As a result of these delays, the cost of many nuclear 
facilities built during this period increased dramatically. To reduce 
such delays, and as authorized the Congress in the Energy Policy Act of 
1992, the NRC adopted a one-step combined ``Construction Permit and 
Operating Licensing`` process. However, the new Construction Permit and 
Operation Licensing process has not been tested, since no new nuclear 
power facility has been ordered and commissioned in over two decades. 
In response to concerns regarding the untested process, EPACT 2005 
allows the Secretary of Energy to enter into contracts with sponsors of 
advanced nuclear power facilities for standby support payments to cover 
the costs related to certain ''covered delays`` (described below) in 
the licensing process.


Summary of Legal Basis:


EPACT 2005 provides for standby support contracts for a total of six 
advanced power reactors consisting of no more than three different 
designs. Under such contracts, the Department would pay for 100 percent 
of the covered costs associated with covered delays for the first two 
reactors, up to $500 million each, and 50 percent of the covered costs 
for the four remaining reactors, up to $250 million each. Covered 
delays include failure of the NRC to comply with schedules for review 
and approval of inspections, tests and analyses, and acceptance 
criteria established by the NRC, and litigation that delays the 
commencement of full-power operations of the advanced nuclear power 
facility. Covered costs include principal or interest on any debt 
obligation and the incremental difference between the fair market price 
of power purchases but for the delay and the contractual price or power 
from the advanced nuclear facility subject to the delay. The Department 
would not cover those costs that are caused by the failure of the 
project sponsor to take any action required by law or regulation, 
events within the control of the sponsor, or normal business risks.


Alternatives:


EPACT 2005, enacted on August 8, 2005, requires the Secretary of Energy 
to issue for public comment an interim final rulemaking governing 
contracts for standby support no later than 270 days after enactment, 
which is May 6, 2006. In addition, DOE is required to finalize the rule 
no later than August 8, 2006. The Department is currently working to 
formulate and implement the rule.


Anticipated Cost and Benefits:


The specific costs and benefits of this rulemaking have not been 
established because the specific aspects of the rule have not been 
determined.


Risks:


Regulatory uncertainty regarding the delay of full-power operations of 
the first advanced nuclear power facilities is viewed as a serious risk 
to sponsors of such nuclear facilities. A regulation providing sponsors 
standby support for advanced nuclear power facilities would provide 
financial incentives for sponsors to build such facilities. Absent such 
a regulation, it is less likely that sponsors will construct new 
nuclear facilities.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Notice of Inquiry               10/00/05
Workshop                        11/00/05
Interim Final Rule              05/00/06
Final Action                    08/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


Timetable reflects program priorities.


Agency Contact:
K. Chuck Wade
Department of Energy
Office of Nuclear Energy, Science and Technology
1000 Independence Avenue, SW
Washington, DC 20585
Phone: 202 586-1889
Email: [email protected]
RIN: 1901-AB17
BILLING CODE 6450-01-S

[[Page 64149]]




DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)



Statement of Regulatory Priorities
The Department of Health and Human Services (HHS) conducts a broad 
range of programs mandated by Congress to protect and promote the 
health and well-being of the American public. HHS programs assist some 
of the nation's most vulnerable populations, including children, the 
elderly, and persons with disabilities. Specifically, these programs 
include: Medicare, Medicaid, support for public health preparedness, 
biomedical research, substance abuse and mental health treatment, 
assurance of 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.
HHS Secretary Michael O. Leavitt uses a 500-Day Plan as a management 
tool to focus his energies in overseeing these programs. The Plan is an 
expression of many of Secretary Leavitt's priorities, and it provides 
direction to the daily leadership and management of the Department. 
(The public may electronically access the Secretary's 500-Day Plan at 
http://www.hhs.gov/500DayPlan.) The strategies articulated in the 500-
Day Plan guide many actions the Department will take during the ensuing 
500-day period to achieve significant progress for the American people 
over the long term.
``Modernizing Medicare and Medicaid'' is one of the goals cited in the 
500-Day Plan. While HHS has largely completed the regulatory framework 
needed for implementation of the Medicare Prescription Drug, 
Improvement and Modernization Act of 2003, many other regulatory 
actions remain necessary to assure the continuing modernization of the 
Medicare and Medicaid programs. The Department wishes to emphasize the 
importance of the following Medicare and Medicaid-related actions by 
including them in its Fiscal Year (FY) 2006 Regulatory Plan:
 final rules establishing new requirements that organ 
            procurement organizations and organ transplant centers must 
            meet to have their services covered by Medicare. 
            Promulgation of the outcome and performance measures in 
            these rules will increase organ donation and 
            transplantation in the United States. The rules will ensure 
            that Medicare-covered transplants are performed in a safe 
            and efficient manner, serving to keep Medicare requirements 
            current with state-of-the-art medical practice in 
            transplantation;
 a proposal to institute competitive bidding procedures to 
            improve the effectiveness of Medicare's current methodology 
            for setting payment amounts for durable medical equipment;
 proposed and final rules establishing annual adjustments in 
            payment amounts under Medicare for physicians' services 
            (for calendar year 2006), and for hospital inpatient and 
            outpatient services (for FY 2007); and
 an advance notice of proposed rulemaking, seeking public input 
            regarding ideas presented in the President's FY 2006 Budget 
            and in a report to Congress by the Medicare Payment 
            Advisory Commission recognizing needs for payment reforms 
            to improve the quality and value of care delivered to 
            Medicare beneficiaries. This initiative explores the 
            concept of ``paying for performance'' as a means of 
            promoting better quality of care in Medicare fee-for-
            service payment systems.
The Secretary's 500-Day Plan also includes a goal with emphasis on 
securing the homeland. The FY 2006 Regulatory Plan accordingly includes 
a notice of proposed rulemaking which would update existing regulations 
related to preventing the introduction, transmission, or spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. The proposed regulations 
would offer for public comment procedures that adequately address 
quarantine in the 21st century. Some of the key provisions in the 
proposed regulations will include: requirements for expanded reporting 
of ill passengers on board foreign and interstate carriers; 
requirements that carriers maintain passenger and crew lists and submit 
such lists electronically upon request; and explicit due process 
protections. These procedures are expected to expedite and improve 
operations by allowing immediate medical follow-up of potentially 
infected passengers and their contacts.
Another of the Secretary's 500-Day Plan strategies involves the 
enabling of health care consumers to be better informed and to have 
more choices. The following regulatory actions included in the FY 2006 
Regulatory Plan reflect this strategy:
 a proposal to move to electronic registration with the Food 
            and Drug Administration (FDA) of drug companies and of 
            listings of the drugs they produce, so that the agency may 
            be better equipped to conduct its postmarketing 
            surveillance programs, and to proactively communicate 
            important information about drug products on the market to 
            providers and patients;
 a proposal to amend FDA's regulations to require that clinical 
            study data be provided in electronic format, using standard 
            data structure, terminology, and code sets. The change 
            would further increase the efficiency of the agency's 
            review processes, thus speeding up the availability of new 
            therapies;
 a final rule requiring the labeling of human drugs to include 
            a toll-free number for reports of adverse events, and a 
            statement that the number is to be used for reporting 
            purposes, not for medical advice;
 a proposal to amend existing regulations governing 
            investigational new drugs, to describe the way patients may 
            obtain investigational drugs for treatment use. Treatment 
            use of investigational drugs would be available to: 
            individual patients, including in emergencies; intermediate 
            size patient populations; and larger populations under a 
            treatment protocol.
 a final rule establishing in regulation good manufacturing 
            practices for the dietary-supplement products favored by 
            many Americans; such a requirement will ensure both product 
            safety and quality, and assure consumers that these 
            products have the identity and quality declared in their 
            labeling;
 a final rule to facilitate health care practitioners' access 
            to prescription-drug labeling information through 
            streamlined formatting requirements for such information, 
            enabling them to better communicate important information 
            to their patients; and
 a proposal to modify prescription drug labeling so that health 
            care providers may better understand and communicate to 
            their patients the risks and benefits of use of medicines 
            during pregnancy and lactation.

[[Page 64150]]

_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




42. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN QUARANTINE

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


Not Yet Determined


CFR Citation:


42 CFR 70; 42 CFR 71


Legal Deadline:


None


Abstract:


By statute, the Secretary of Health and Human Services (HHS) has broad 
authority to prevent introduction, transmission, and spread of 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. Quarantine regulations are 
divided into two parts: part 71 dealing with foreign arrivals and part 
70 dealing with interstate matters. The Secretary has delegated the 
authority to prevent the introduction of diseases from foreign 
countries to the Director, CDC. Interstate authority is split between 
CDC and the Food and Drug Administration (FDA), with CDC delegated 
interstate authority as it pertains to humans. CDC maintains quarantine 
stations at 8 major airports with quarantine inspectors who respond to 
reports of diseases from carriers. According to the statutory scheme, 
the President of the United States determines through Executive order 
which diseases may subject individuals to quarantine. The current 
disease list, which was last updated in April 2005, includes cholera, 
diphtheria, tuberculosis, plague, smallpox, yellow fever, viral 
hemorrhagic fevers, and Severe Acute Respiratory Syndrome (SARS) and 
influenza caused by novel or remergent influenza virus that are 
causing, or have the potential to cause, a pandemic.


Statement of Need:


The quarantine of persons believed to be infected with communicable 
diseases is a long-term prevention measure that has been used 
effectively to contain the spread of disease. As diseases evolve due to 
natural occurrences or man-made events, it is important to ensure that 
prevention procedures reflect new threats and uniform ways to contain 
them. Recent experiences with emerging infectious diseases such as West 
Nile Virus, SARS, and monkeypox have illustrated the rapidity with 
which disease may spread throughout the world, and the impact 
communicable diseases, when left unchecked, may have on the global 
economy. Stopping an outbreak -- whether it is naturally occurring or 
intentionally caused -- requires the use of the most rapid and 
effective public health tools available. One of those tools is 
quarantine -- restricting the movement of persons exposed to infection 
to prevent them from infecting others, including family members, 
friends, and neighbors. Quarantine of exposed persons may be the best 
initial way to prevent the uncontrolled spread of highly dangerous 
biologic agents -- especially when combined with other health 
strategies such as vaccination, prophylactic drug treatment, patient 
isolation, and other appropriate infection control measures.


Summary of Legal Basis:


These regulations would be proposed under the authority of 25 U.S.C. 
198, 231, 2001; 42 U.S.C. 243, 264-271. In addition, Section 361(b) of 
the Public Health Service Act (42 U.S.C. 264(b)) authorizes the 
``apprehension, detention, or conditional release'' of persons to 
prevent the introduction, transmission, and spread of specified 
communicable diseases from foreign countries into the United States and 
from one State or possession into another. Among other public health 
powers, the lawful ability to inspect property, to medically examine 
and monitor persons, and to detain or quarantine exists in current 
regulations. Acknowledging the critical importance of protecting the 
public's health, long-standing court decisions uphold the ability of 
Congress and State legislatures to enact quarantine and other public 
health laws, and to have them executed by public health officials.


Alternatives:


The proposed regulations are necessary to ensure that HHS has the tools 
it needs to respond to public health emergencies and disease threats. 
Any less stringent alternatives would prevent the Department from the 
most effective possible pursuit of this objective. From a due process 
perspective, the proposed regulation would clarify administrative 
procedures, and would detail the elements generally recognized as 
essential to comport with constitutional requirements. Those elements 
include: Reasonable and adequate notice; opportunity to be heard in a 
reasonable time and manner; access to legal counsel; review by an 
impartial decision-maker; and written articulation of the rationale 
underlying the decision.


Anticipated Cost and Benefits:


The primary cost impact of the proposed rule would be the collection 
and maintenance of crew and passenger manifest data. by air and water 
carriers that are likely to modify computer systems and collect 
passenger information to come into compliance. The benefits of the rule 
would be measured in terms of the number of deaths and illnesses 
prevented by rapid intervention. When the costs and benefits of the 
rule are considered over a 20-year period benefits clearly outweigh 
costs.


Risks:


Failure to move forward with this rulemaking would hinder the Nation's 
ability to use the most rapid and effective public health tools 
available when responding to public health emergencies and disease 
threats.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            11/00/05

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 64151]]

Agency Contact:
Ram Koppaka M.D., Ph.D.
Department of Health and Human Services
Centers for Disease Control and Prevention
MS-E-03
1600 Clifton Road
Atlanta, GA 30333
Phone: 404 498-2308
RIN: 0920-AA12
_______________________________________________________________________



HHS--Food and Drug Administration (FDA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




43. FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING 
REQUIREMENTS FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER 
A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS

Priority:


Other Significant


Legal Authority:


21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 360; 
21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262; 42 USC 264; 42 USC 271


CFR Citation:


21 CFR 20; 21 CFR 201; 21 CFR 207; 21 CFR 314; 21 CFR 330; 21 CFR 514; 
21 CFR 515; 21 CFR 601; 21 CFR 607; 21 CFR 610; 21 CFR 1271


Legal Deadline:


None


Abstract:


The proposed rule would reorganize, consolidate, clarify, and modify 
current regulations at 21 CFR part 207 concerning who must register 
establishments and list human drugs, certain biological drugs, and 
animal drugs. These regulations contain information on when, how, and 
where to register drug establishments and list drugs, and what 
information must be submitted for initial registration and listing and 
for changes to registration and listing. The proposed rule would 
require that this information be submitted via the Internet into the 
FDA registration and listing database, instead of the current 
requirement to submit the information to FDA on paper forms. The 
proposed rule would also require that the NDC number appear on drug 
labels. In addition, FDA would assign the NDC number to newly listed 
drugs and take other steps to minimize the use of inaccurate NDC 
numbers on drug labels.


Statement of Need:


FDA relies on establishment registration and drug listing for 
administering its postmarketing surveillance programs, such as 
identifying firms that manufacture a specific product or ingredient 
when that product or ingredient is in short supply or needed for a 
national emergency, for example, during a bioterrorism threat. FDA also 
uses registration and listing information for administering other 
programs such as assessing user fees. FDA is taking this action to 
improve its establishment registration and drug listing system and to 
utilize the latest technology in the collection of this information. In 
addition, improving the accuracy of and requiring NDC numbers on drug 
labels would help promote the Department's bar code, medication errors, 
and electronic prescribing initiatives.


Summary of Legal Basis:


The agency has broad authority under sections 301(p), 502(o), 510, and 
701(a) of the act and sections 351 and 361 of the Public Health Service 
Act (PHS Act) to regulate certain establishments with respect to their 
submission of registration and listing information. Failure to register 
in accordance with section 510 of the act is a prohibited act under 
section 301(p) of the act. Failure to comply with section 510 of the 
act renders drugs misbranded under section 502(o) of the act.


Alternatives:


The alternatives to this rulemaking include not updating the 
registration and listing regulations and not requiring the electronic 
submission of registration and listing information. FDA originally 
published the registration regulations in 1963 and the listing 
regulations in 1973. The registration and listing paper forms that are 
currently mailed to FDA have been in use since that time. For the 
reasons stated above, and as a result of the advances in data 
collection and transmission technology, FDA believes this rulemaking is 
the preferable alternative.


Anticipated Cost and Benefits:


FDA estimates that the costs to industry resulting from the proposed 
rule would include annually recurring and one-time costs. The recurring 
costs would include, among other things, measures taken by registrants 
to protect the integrity of FDA's registration and listing database 
(such as the use of a unique electronic identifier). The one-time costs 
would include, among other things, additional time required to enter 
registration and listing data into FDA's database. In addition, certain 
registrants would need to convert their labeling to an electronically 
searchable format the first time they electronically list these 
products. The specific cost to FDA of developing, administering, and 
maintaining the Electronic Drug Registration and Listing System (EDRLS) 
is being calculated. EDRLS will not be ready for use until the rule is 
finalized.


FDA believes that electronic registration and listing will be less 
costly to industry in the long run than the current requirements. The 
proposed rule would require less establishment and product information 
from many registrants and savings would result from not having to 
process paper copies of the registration and listing forms. The 
electronic registration and listing process would also enable 
registrants to receive on-screen feedback if the information submitted 
is not complete, reducing errors and the time and cost of communicating 
back and forth with FDA. Information search and retrieval time will 
also be reduced for FDA, allowing for quicker agency response time.


The proposal would make the regulations more user-friendly and would 
make the registration and listing process easier by incorporating the 
use of the Internet to submit all information. The proposal would 
improve the ability to identify and catalogue marketed drugs by helping 
to eliminate inaccurate NDC numbers on drug labels.


Risks:


None


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            01/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 64152]]

Agency Contact:
Howard P. Muller
Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7)
Center for Drug Evaluation and Research
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AA49
_______________________________________________________________________



HHS--FDA



44. SUBMISSION OF STANDARDIZED ELECTRONIC STUDY DATA FROM CLINICAL 
STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS

Priority:


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


Legal Authority:


21 USC 355; 21 USC 371; 42 USC 262


CFR Citation:


21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94


Legal Deadline:


None


Abstract:


The Food and Drug Administration is proposing to amend the regulations 
governing the format in which clinical study data (CSD) are required to 
be submitted for new drug applications (NDAs), biological license 
applications (BLAs), and abbreviated new drug applications (ANDAs). The 
proposal would revise our regulations to require that CSD submitted for 
NDAs, BLAs, and ANDAs, and their supplements and amendments be provided 
in an electronic format that FDA can process, review, and archive. The 
proposal would also require the use of standardized data structure, 
terminology, and code sets to allow for more efficient and 
comprehensive review of CSD.


Statement of Need:


Before a drug is approved for marketing, FDA must determine that the 
drug is safe and effective for its intended use. This determination is 
based in part on clinical study data (CSD) that are submitted as part 
of the marketing application. At present, FDA accepts CSD in paper and 
electronic formats. When CSD are submitted to FDA only on paper, the 
information must be transcribed by hand into electronic form for review 
and analysis. This process is extremely time consuming and is prone to 
data entry error. CSD submitted to FDA in electronic format have 
generally been more efficient to process and review.


FDA's proposed rule would require the submission of CSD in a 
standardized electronic format. The standardized CSD format would 
improve patient safety and enhance health care delivery by enabling FDA 
to process, review, and archive CSD more efficiently. Standardization 
of CSD would also enhance the ability to share study data and 
communicate results. Investigators and industry would benefit from the 
use of standards throughout the lifecycle of a study--in data 
collection, reporting, and analysis. The proposal would work in concert 
with ongoing agency and national initiatives to support increased use 
of electronic technology as a means to improve patient safety and 
enhance health care delivery.


Summary of Legal Basis:


Our legal authority to amend our regulations governing the submission 
and format of CSD for human drugs and biologics derives from sections 
505 and 701 of the act (U.S.C. 355 and 371) and section 351 of the 
Public Health Service Act (42 U.S.C. 262).


Alternatives:


FDA considered issuing a guidance document outlining the electronic 
submission and the standardization of CSD, but not requiring electronic 
submission of CSD in the standardized format. This alternative was 
rejected because the agency would not fully benefit from 
standardization until it became the industry standard, which could take 
up to 20 years.


We also considered a number of different implementation scenarios, from 
shorter to longer time-periods. The two-year time-period was selected 
because the agency believes it would provide ample time for applicants 
to comply without too long a delay in the effective date. A longer 
time-period would delay the benefit from the increased efficiencies, 
such as standardization of review tools across applications, and the 
incremental cost saving to industry would be small.


Anticipated Cost and Benefits:


FDA estimates that the costs to industry resulting from the proposal 
would include some one-time costs and some potential annual recurring 
costs. One-time costs would include, among other things, the cost of 
converting CSD to standard structures, terminology, and cost sets 
(i.e., purchase of software to convert CSD); the cost of submitting 
electronic CSD (i.e., purchase of file transfer programs); and the cost 
of installing and validating the software and training personnel. 
Additional annual recurring costs may result from software purchases 
and licensing agreements for use of proprietary terminologies.


The proposal could result in many long-term benefits for industry and 
for the agency, including improved patient safety through more 
efficient, comprehensive, and accurate data review; enhanced 
communication among sponsors, clinicians, and FDA through improved 
access to and sharing of CSD; and reduced data management costs through 
the standardization of data formats.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            06/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Martha Nguyen
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Regulatory Policy
5515 Security Lane, Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301-827-5562
Email: [email protected]
RIN: 0910-AC52

[[Page 64153]]

_______________________________________________________________________



HHS--FDA



45. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND 
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING

Priority:


Other Significant


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 201.57


Legal Deadline:


None


Abstract:


To amend the regulations governing the format and content of labeling 
for human prescription drugs and biological products (21 CFR 201.56 and 
201.57).


Statement of Need:


Under FDA's current regulations, labeling concerning the use of 
prescription drugs in pregnancy uses letter categories (A, B, C, D, X) 
to characterize the risk to the fetus of using the drug during 
pregnancy. Dissatisfaction with the category system has been expressed 
by health care providers, medical organizations, experts in the study 
of birth defects, women's health researchers, and women of childbearing 
age. These stakeholders have expressed the view that the current 
categories are confusing and overly simplistic and thus are not 
adequate to communicate risks effectively. One of the deficiencies of 
the category system is that drugs may be assigned to the same category 
when the severity, incidence, and types of risk are quite different.


Stakeholders consulted through a public hearing, several focus groups, 
and several advisory committees have recommended that FDA replace the 
category system with a concise narrative summarizing a product's risks 
to pregnant women and to women of childbearing age. It has also been 
strongly recommended that pregnancy labeling address the situation 
where a woman has taken drugs before she realizes she is pregnant. The 
labeling that would be required under the proposed rule would be 
responsive to the concerns discussed above, and others that have been 
expressed by critics of the current category system.


Summary of Legal Basis:


FDA 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 help ensure that 
prescription drugs (including biological products that are regulated as 
drugs) are safe and effective for their intended uses. A major part of 
FDA's efforts concerning the safe and effective use of drug products 
involves review, approval, and monitoring of drug labeling. Under 
section 502(f)(1) of the Act, a drug is misbranded unless its labeling 
bears ``adequate directions for use'' or it is exempted from this 
requirement by regulation. Under section 201.100 (21 CFR 201.100), a 
prescription drug is exempted from the requirement in section 502(f)(1) 
of the Act only if, among other things, it contains the information 
required and 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 or may 
withdraw 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 consequences which may 
result from use of the drug product under the conditions of use 
prescribed in the labeling or under customary 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 
publish a proposed rule designed to help ensure that practitioners 
prescribing drugs (including biological products) to pregnant women and 
women of childbearing age would receive information essential to the 
safe and effective use of these drugs.


Alternatives:


The alternatives to the proposal include not amending our existing 
regulation governing the format and content of labeling for human 
prescription drugs and biological products. This alternative is 
inconsistent with widespread stakeholder dissatisfaction with the 
pregnancy labeling provided pursuant to the current regulation.


Anticipated Cost and Benefits:


The proposed rule would impose one-time costs for firms to modify drug 
product labeling. The extent of these modifications would depend on 
whether a product's labeling is affected by the physician labeling 
final rule (PLR). If the labeling is affected by the PLR, firms would 
be required to revise the pregnancy labeling section according to the 
new content and format requirements of the pregnancy rule and to submit 
the revised labeling to FDA for approval. For product labeling of older 
products not affected by the PLR, the current pregnancy category would 
be removed. In addition to the one-time costs, firms would incur 
ongoing incremental printing costs for product labeling affected by the 
PLR. Over 7 years, the present value of the total costs of the proposed 
rule is anticipated to range from about $25 million with a 7 percent 
discount rate to about $30 million with a 3 percent discount rate.


The revised format and the information provided in the labeling would 
make it easier for health care providers to understand the risks and 
benefits of drug use during pregnancy and lactation. A better 
understanding of risks and benefits would help women and their 
healthcare providers make informed decisions about whether or not to 
use drugs during pregnancy and lactation. Labeling under the rule would 
also provide information geared to women who took drugs before they 
knew they were pregnant. Such information may often be reassuring to 
women and their health care providers.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses

[[Page 64154]]

Government Levels Affected:


None


Agency Contact:
Christine F. Rogers
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3059 (HFD-7)
Center for Drug Evaulation and Research
5515 Security Lane
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301-827-5562
Email: [email protected]
RIN: 0910-AF11
_______________________________________________________________________



HHS--FDA



46. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE

Priority:


Other Significant


Legal Authority:


21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 353; 21 USC 355; 21 
USC 371; 42 USC 262


CFR Citation:


21 CFR 312.42; 21 CFR 312.300; 21 CFR 312.305; 21 CFR 312.310; 21 CFR 
312.315; 21 CFR 312.320


Legal Deadline:


None


Abstract:


To amend the regulations governing investigational new drugs (INDs) to 
describe the ways patients may obtain investigational drugs for 
treatment use. Treatment use of investigational drugs would be 
available to: (1) individual patients, including in emergencies; (2) 
intermediate size patient populations; and (3) larger populations under 
a treatment protocol or IND.


Statement of Need:


The Food and Drug Administration Modernization Act of 1997 
(Modernization Act) amended the Federal Food, Drug, and Cosmetic Act 
(the act) to include specific provisions concerning expanded access to 
investigational drugs for treatment use. In particular, section 561(b) 
of the act permits any person, acting through a licensed physician, to 
request access to an investigational drug to diagnose, monitor, or 
treat a serious disease or condition provided that a number of 
conditions are met. The proposed rule is needed to incorporate into 
FDA's regulations this and other provisions of the Modernization Act 
concerning access to investigational drugs.


In addition, by this proposed rule, the agency seeks to increase 
awareness and knowledge of expanded programs and the procedures for 
obtaining investigational drugs for treatment use. The proposed rule 
would assist in achieving this goal by describing in detail the 
criteria, submission requirements, and safeguards applicable to 
different types of treatment uses.


Summary of Legal Basis:


FDA has the authority to impose requirements concerning the treatment 
use of investigational drugs under various sections of the act, 
including sections 505(i), 561, and 701(a) (21 U.S.C. 355(i), 360bbb, 
and 371(a)).


Section 505(i) of the Act directs the Secretary to promulgate 
regulations exempting from the operation of the new drug approval 
requirements drugs intended solely for investigational use by experts 
qualified by scientific training and expertise to investigate the 
safety and effectiveness of drugs. The proposed rule explains 
procedures and criteria for obtaining FDA authorization for treatment 
uses of investigational drugs.


The Modernization Act provides significant additional authority for 
this proposed rule. Section 561(a) states that the Secretary may, under 
appropriate conditions determined by the Secretary, authorize the 
shipment of investigational drugs for the diagnosis, monitoring, or 
treatment of a serious disease or condition in emergency situations. 
Section 561(b) allows any person, acting through a physician licensed 
in accordance with State law, to request from a manufacturer or 
distributor an investigational drug for the diagnosis, monitoring, or 
treatment of a serious disease or condition if certain conditions are 
met. Section 561(c) closely tracks existing FDA's existing regulation 
at 21 CFR 312.34 providing for treatment use by large patient 
populations under a treatment protocol or treatment IND if a number of 
conditions are met.


Section 701(a) provides the Secretary with the general authority to 
promulgate regulations for the efficient enforcement of the act. By 
clarifying the criteria and procedures relating to treatment use of 
investigational products, this proposed rule is expected to aid in the 
efficient enforcement of the act.


Alternatives:


One alternative to the proposed rule that FDA considered was not to 
propose regulations implementing the expanded access provisions of the 
Modernization Act. However, the agency believes that implementing 
regulations would further improve the availability of investigational 
drugs for treatment use by providing clear direction to sponsors, 
patients, and licensed physicians about the criteria for authorizing 
treatment use and what information must be submitted to FDA.


Another alternative FDA considered was to propose a regulation 
describing only those types of treatment use that are specifically 
described in the Modernization Act. However, the agency concluded that 
it would be preferable to establish, as authorized by the Modernization 
Act, a third category of treatment use that would be used for more than 
an individual patient, but fewer than the large numbers of patients in 
treatment INDs or treatment protocols.


Anticipated Cost and Benefits:


FDA expects that the total one-time costs of the proposed rule will be 
negligible. The agency expects that the annual and annualized costs of 
the proposed rule will range from a low of about $130,000 to $260,000 
in the first year following publication of any final rule based on this 
proposal, to a high of about $350,000 to $690,000 in the fourth and 
fifth years. These estimates suggest that total annual and annualized 
costs for the proposed rule would be between $1.4 million and $2.7 
million for the 5-year period following implementation of any final 
rule based on this proposal. The agency also expects that the estimated 
incremental cost burdens associated with this proposed rule are likely 
to be widely dispersed among affected entities.


The benefits of the proposed rule are expected to result from improved 
patient access to investigational drugs generally and from treatment 
use being made available for a broader variety of disease conditions 
and treatment settings. In particular, the clarification of eligibility 
criteria and submission requirements would enhance patient access by 
easing the administrative burdens on individual physicians seeking 
investigational drugs for their patients and on sponsors who make 
investigational drugs available for treatment use.

[[Page 64155]]

Risks:


The agency foresees no risks associated with the proposed rule.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            04/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Organizations


Government Levels Affected:


None


Agency Contact:
Christine F. Rogers
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3059 (HFD-7)
Center for Drug Evaulation and Research
5515 Security Lane
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301-827-5562
Email: [email protected]
RIN: 0910-AF14
_______________________________________________________________________



HHS--FDA

                              -----------

                            FINAL RULE STAGE

                              -----------




47. REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN 
PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS

Priority:


Other Significant


Legal Authority:


21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 371; 42 
USC 262


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 drugs (including biological products that are regulated as 
drugs), 21 CFR 201.56 and 201.57. The regulation would require that 
such labeling include highlights of prescribing information and a table 
of contents for prescribing information. It would reorder currently 
required information, make minor changes to its content, and establish 
minimum graphical requirements.


Statement of Need:


The current format and content requirements in sections 201.56 and 
201.57 were established in 1979 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 increasing product liability and 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 labeling.


FDA took numerous steps to evaluate the usefulness of labeling for 
practitioners 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 labeling is used by 
health care practitioners, what labeling information is most important 
to practitioners, and how labeling should be revised to improve its 
usefulness to 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. FDA 
received written comments and 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, published in 2000, described format and content 
requirements for prescription drug labeling that incorporate 
information and ideas gathered during this process. The comment period 
was extended until June 22, 2001, and the agency received close to 100 
comments on the proposal.


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 help ensure that 
prescription drugs (including biological products that are regulated as 
drugs) are safe and effective for their intended uses. A major part of 
FDA's efforts regarding the safe and effective use of drug products 
involves FDA's review, approval, and monitoring of drug labeling. Under 
section 502(f)(1) of the Act, a drug is misbranded unless its labeling 
bears ``adequate directions for use'' or it is exempted from this 
requirement by regulation. Under section 201.100 (21 CFR 201.100), a 
prescription drug is exempted from the requirement in section 502(f)(1) 
of the Act only if, among other things, it contains the information 
required, in the format specified, by sections 201.56 and 201.57.


Under section 502(a) of the Act, a drug product is misbranded if its 
labeling is false or misleading in any particular. Under section 505(d) 
and 505(e) of the Act, FDA must refuse to approve an application and 
may withdraw the approval of an application if the labeling for the 
drug is false or misleading in any particular. Section 201(n) of the 
Act provides that in determining whether the labeling of a drug is 
misleading, there shall be taken into account not only representations 
or suggestions made in the labeling, but also the extent to which the 
labeling fails to reveal facts that are material in light of such 
representations or material with respect to the consequences which may 
result from use of the drug product under the conditions of use 
prescribed in the labeling or under customary usual conditions of use.


These statutory provisions, combined with section 701(a) of the Act and 
section 351 of the Public Health Service Act, clearly authorize FDA to 
promulgate a final regulation designed to help ensure that 
practitioners prescribing drugs (including biological products) will 
receive information essential to their safe and effective use in a 
format that makes the information easier to access, read, and use.


Alternatives:


The alternatives to the final rule include not amending the content and

[[Page 64156]]

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 
highlights of the most important prescribing information, a table of 
contents 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 product labeling 
information.


Anticipated Cost and Benefits:


The purpose of this rule is to make it easier for health care 
practitioners to access, read and use information in prescription drug 
labeling, thereby increasing the extent to which they rely on labeling 
to obtain information. FDA believes the revisions to the content and 
format of labeling will enhance the safe and effective use of 
prescription drug products, and in turn, reduce the number of adverse 
reactions resulting from medication errors due to misunderstood or 
wrongly applied drug information. The new requirements are important to 
the success of other initiatives aimed at improving patient care and 
decreasing the likelihood of medication errors. For example, revised 
labeling will facilitate initiatives to process, review and archive 
labeling electronically and provide a mechanism to facilitate the 
development of electronic prescribing systems.


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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/22/00                    65 FR 81082
NPRM Comment Period End         03/22/01
NPRM Comment Period 
    Reopened                    03/30/01                    66 FR 17375
NPRM Comment Period 
    Reopening End               06/22/01
Final Action                    11/00/05

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Elizabeth J. Sadove
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research Administration
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AA94
_______________________________________________________________________



HHS--FDA



48. 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 or 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, e.g., which have the identity and provide the 
quantity of dietary ingredients declared in labeling.


Statement of Need:


FDA intends to publish a final 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

[[Page 64157]]

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, 
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                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           02/06/97                     62 FR 5700
ANPRM Comment Period End        06/06/97
NPRM                            03/13/03                    68 FR 12157
NPRM Comment Period End         08/11/03
Final Action                    12/00/05

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Linda Kahl
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-206
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
HFS-024
College Park, MD 20740
Phone: 301 436-1209
Fax: 301 436-2964
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________



HHS--FDA



49. 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.


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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            04/22/04                    69 FR 21778
NPRM Comment Period End         07/21/04
Final Action                    06/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None

[[Page 64158]]

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
5515 Security Lane
Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
RIN: 0910-AC35
_______________________________________________________________________



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

                              -----------

                             PRERULE STAGE

                              -----------




50.  INNOVATIONS IN FEE-FOR-SERVICE PAYMENT SYSTEMS TO IMPROVE 
QUALITY AND OUTCOMES (CMS-1298-ANPR)

Priority:


Other Significant


Legal Authority:


None


CFR Citation:


None


Legal Deadline:


None


Abstract:


This advance notice of proposed rulemaking explores the concept of 
``paying for performance'' as a means of promoting better quality of 
care in Medicare fee-for-service payment systems. It explains the 
concept in general and reports on a number of activities of the Center 
for Medicare and Medicaid Services measuring and reporting and in 
possible ways these results could be used to create financial 
incentives for high quality care. The notice seeks public comments on 
these ideas.


Statement of Need:


The President's FY 2006 Budget and the Medicare Payment Advisory 
Commission (MedPAC) 2005 Report to Congress recognized the need for 
payment reforms to improve the quality and value of care delivered to 
Medicare beneficiaries. Currently, Medicare fee-for-service payment 
systems pay health care physicians and providers a pre-determined 
amount based on the number and complexity of covered services provided 
to patients regardless of quality, efficiency, or impact on beneficiary 
health outcomes. CMS is examining ways to introduce enhanced methods of 
payment into the Original Medicare program that will improve the 
quality and value of care delivered to Medicare beneficiaries, 
particularly the concept of ``paying for performance.'' This notice 
seeks public comment on paying for performance to create greater 
financial support and incentives for high quality care.


Summary of Legal Basis:


The purpose of this notice is to examine potential innovations to 
Medicare's fee-for-service payment systems and to seek public comment 
on those ideas. Because the notice only seeks comments, no specific 
legal authority is required.


Alternatives:


The notice examines and seeks public comment on paying for performance, 
one potential innovation to Medicare's fee-for-service payment systems. 
Interested parties are asked to comment on the issues set forth in the 
notice, but are free to comment on alternative innovations.


Anticipated Cost and Benefits:


This Medicare initiative explores the potential benefits of ``paying 
for performance'' as a means of promoting better quality of care and 
health outcomes for beneficiaries and for promoting efficiency in 
Medicare fee-for-service payment systems. No costs are anticipated at 
this time.


Risks:


Developing and implementing innovations in Medicare's fee-for-service 
payment systems requires careful planning and extensive interaction 
with interested parties. Seeking public comments will assist CMS in 
fully considering issues and developing policies.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Gay W. Burton
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244
Phone: 410 786-4564
Email: [email protected]

Teresa Clark
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244
Phone: 410 786-1079
Email: [email protected]
RIN: 0938-AN91
_______________________________________________________________________



HHS--CMS

                              -----------

                          PROPOSED RULE STAGE

                              -----------




51. COMPETITIVE ACQUISITION FOR CERTAIN DURABLE MEDICAL EQUIPMENT 
(DME), PROSTHETICS, ORTHOTICS, AND SUPPLIES AND RESIDUAL ISSUES (CMS-
1270-P)

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


PL 108-173, MMA


CFR Citation:


42 CFR 414.200; 42 CFR 405.502(g); 42 CFR 424.57; 42 CFR 410.38


Legal Deadline:


Final, Statutory, January 1, 2007.


Abstract:


Section 302 of the Medicare Modernization Act establishes DME 
competitive bidding. National competitive bidding will provide a 
program for using market forces to set Medicare payment amounts. This 
will also create incentives for suppliers to provide quality items and 
services while at the same time providing Medicare with reasonable 
prices for payment. (The statute requires competitive bidding be 
implemented by January 1, 2007.)


Statement of Need:


Section 302 of the Medicare Prescription Drug Improvement, and 
Modernization Act of 2003

[[Page 64159]]

(MMA)(Pub.L. 108-173) authorizes the Secretary to use our competitive 
acquisition authority, as outlined in the U.S. Code Section 1847(a). 
Section302 (b)(1) of the Medicare Modernization Act, requires Medicare 
to replace the current DME payment methodology for certain items with a 
competitive bidding process to improve the effectiveness of its 
methodology for setting DME payment amounts.


The competitive bidding program is to be phased-in over a 4-year period 
beginning in 2007. The law requires that competitive bidding be 
conducted in ten of the largest metropolitan statistical areas in 2007, 
in 80 of the largest metropolitan statistical areas in 2009, and in 
additional areas after 2009.


Summary of Legal Basis:


MMA Section 302 (b)(1)


Alternatives:


None. Required by MMA.


Anticipated Cost and Benefits:


This initiative will result in substantial savings to the Medicare 
program.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            11/00/05
Final Action                    08/00/08

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State


Agency Contact:
Michael Keane
Health Policy Analyst
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicare Management
C5-08-27
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-4495
Email: [email protected]
RIN: 0938-AN14
_______________________________________________________________________



HHS--CMS



52.  CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT 
SYSTEMS AND FY 2007 RATES (CMS-1488-P)

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


Sec 1886(d) of the Social Security Act


CFR Citation:


42 CFR 405; 42 CFR 412; 42 CFR 413; 42 CFR 415; 42 CFR 419; 42 CFR 422; 
42 CFR 485


Legal Deadline:


NPRM, Statutory, April 1, 2006.


Final, Statutory, August 1, 2006.


Abstract:


This rule proposes to revise the Medicare hospital inpatient 
prospective payment systems (IPPS) for operating and capital-related 
costs to implement changes arising from our continuing experience with 
these systems. The Addendum to this proposed rule proposes changes to 
the amounts and factors used to determine the rates for Medicare 
hospital inpatient services for operating costs and capital-related 
costs. These proposed changes would apply to discharges occurring on or 
after 10/1/06. It also proposes rate-of-increase limits as well as 
proposed policy changes for hospitals and hospital units excluded from 
the IPPS that are paid in full or in part on a reasonable cost basis 
subject to these limits.


Statement of Need:


The statute requires by law that we publish each year a proposed rule, 
followed by a final rule, on the acute care hospital inpatient 
prospective payment systems(IPPS) annual updates to the payment rates 
and related hospital inpatient policy changes under the Medicare 
program. Medicare pays for acute care hospital inpatient services under 
a prospective payment system (IPPS) in which payment is made at a 
predetermined rate for the operating and capital-related costs 
associated with each hospital discharge. Payment rates for IPPS 
hospitals and the payment limits for hospitals excluded from IPPS are 
updated each year to take into account changes in the cost of goods and 
services used by hospital, as well as other factors.


Summary of Legal Basis:


Section 1886(d) of the Social Security Act establishes payment for 
inpatient hospital services. (The statute requires that this proposed 
rule be published by 4/1/06. It also requires that the subsequent final 
rule be published by 8/1/06.)


Alternatives:


None. This is a statutory requirement.


Anticipated Cost and Benefits:


We project the payment rate updates to hospitals would increase by over 
$3 billion from FY 2006 to FY 2007. Total IPPS payments are 
approximately $110 billion.


Risks:


If this regulation is not published timely, hospital impatient services 
will not be paid appropriately.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            04/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Marc Hartstein
Acting Deputy Director, Division of Acute Care Hospital and Ambulatory 
Policy Group
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicare Management
Mailstop C4-25-11
7500 Security Boulevard
Baltimore, MD 21244-1850
Phone: 410 786-6192
Email: [email protected]
RIN: 0938-AO12

[[Page 64160]]

_______________________________________________________________________



HHS--CMS

                              -----------

                            FINAL RULE STAGE

                              -----------




53. ORGAN PROCUREMENT ORGANIZATION CONDITIONS FOR COVERAGE (CMS-3064-
IFR) (SECTION 610 REVIEW)

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 1302 et al


CFR Citation:


42 CFR 413; 42 CFR 441; 42 CFR 486; 42 CFR 498


Legal Deadline:


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


Abstract:


This rule establishes 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:


As required by the Organ Procurement Organization Certification Act of 
2000 and Section 219 of the Consolidated Appropriations Act, 2001, this 
rule sets forth multiple new outcome and process performance measures 
for OPOs, as well as a new appeals process for OPOs to appeal a 
decertification based on substantive and procedural grounds.


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 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 
re-certified 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 (42 U.S.C. Section 273(b)(1)(D)) amended section 371(b) of the PHS 
Act to require CMS to promulgate multiple new outcome and process 
performance measures for OPOs and develop a new process for OPOs to 
appeal a de-certification based on substantive and procedural grounds.


In addition, section 1102 of the Act gives the Secretary the authority 
to make and publish such rules and regulations as may be necessary to 
the efficient administration of the functions with which the Secretary 
is charged under the Act. This section of the Act gives the Secretary 
broad authority to establish requirements for OPOs that are necessary 
for the efficient administration of the Medicare program.


Alternatives:


CMS has considered various alternatives in developing outcome and 
process performance measures. CMS will implement measures based on 
donor potential and other related factors in OPO service areas.


Anticipated Cost and Benefits:


CMS believes the provisions contained in this rule would have little or 
no economic impact on hospitals. CMS' best estimate of the impact of 
this proposed rule is a benefit of more than $1 billion each year, 
based on the number of lives we expect would be saved by an increase in 
organ donation and transplantation due to increased OPO performance, 
thereby decreasing deaths of patients waiting for organs. Increasing 
organ donation and transplantation is a priority for the Secretary as 
evidenced by the Secretary's Donation Initiative (Initiative); launch 
of the Initiative was one of the Secretary's first actions.


In addition, the rule includes requirements to guard against medical 
errors that can lead to transplantation of organs of the wrong blood 
type or transmission of infectious disease to transplant recipients.


Risks:


Failure to publish the rule may decrease organ donation and 
transplantation, thereby increasing deaths of patients waiting for 
organs.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              12/28/01                    66 FR 67109
NPRM                            02/04/05                     70 FR 6086
Interim Final Rule              12/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Diane Corning
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Clinical Standards Group
Mailstop S3-02-01
7500 Security Boulevard
Baltimore, MD 21224
Phone: 410 786-8486
Email: [email protected]
RIN: 0938-AK81
_______________________________________________________________________



HHS--CMS



54. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CALENDAR YEAR 2006 PAYMENT RATES (CMS-1501-FC)

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


BBA; BBRA; BIPA; MMA


CFR Citation:


Not Yet Determined


Legal Deadline:


Final, Statutory, November 1, 2005.


Abstract:


The final rule would adjust payments under the Medicare hospital 
outpatient payment system beginning January 1, 2006.


Statement of Need:


Medicare pays over 4,200 hospitals for outpatient department services 
under the Outpatient Prospective Payment

[[Page 64161]]

System. The OPPS is based on groups of clinically similar services 
called Ambulatory Payment Classifications (APCs). CMS annually revises 
the APC payment amounts based on claims data, proposes new payment 
polices, and updates the payments for inflation using the market 
basket. The proposed and final rule solicit comments on the proposed 
OPPS payment rates and new policies. This final does not impact 
payments to Critical Access Hospitals as they are not paid under the 
OPPS.


Summary of Legal Basis:


Section 1833(t) of the Social Security Act establishes Medicare payment 
for hospital outpatient services. The proposed and final rules revise 
the Medicare hospital outpatient prospective payment system (OPPS) to 
implement applicable statutory requirements and changes arising from 
our continuing experience with this system and to implement certain 
related provisions of the Medicare Prescription Drug Improvement, and 
Modernization Act (MMA) of 2003, Pub. L. 108-173. In addition, the 
proposed and final rule describes changes to the amounts and factors 
used to determine the payment rates for Medicare hospital outpatient 
services paid under the prospective payment system. These changes would 
be applicable to services furnished on or after January 1, 2006.


Alternatives:


None. This is a statutory requirement.


Anticipated Cost and Benefits:


The estimated outpatient hospital expenditures in 2006 will approximate 
more than $27 billion.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            07/25/05                    70 FR 42674
Final Action                    11/00/05

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Agency Contact:
Rebecca Kane
Health Insurance Specialist, Hospital and Ambulatory Policy Group
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Mailstop C4-01-26
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-1589
Email: [email protected]
RIN: 0938-AN46
_______________________________________________________________________



HHS--CMS



55. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2006 (CMS-1502-FC)

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


Social Security Act, sec 1102; Social Security Act, sec 1871


CFR Citation:


42 CFR 410; 42 CFR 414


Legal Deadline:


Final, Statutory, November 1, 2005.


Abstract:


This rule would make several changes affecting the Medicare part B 
payment. This rule also finalizes portions of an interim final rule 
published on July 6, 2005 (70 FR 39022) establishing a competitive 
acquisition program for purchase of some Part B drugs.


Statement of Need:


The statute requires that we establish each year, by regulation, 
payment amounts for all physician's services furnished in all fee 
schedule areas. The statute also requires that annual adjustments to 
physician fee schedule RVUs not cause annual payments to differ by more 
than $20 million from what they would have been had the adjustments not 
been made. If adjustments to preserve budget neutrality.


Under the physician fee schedule, we assign RVUs to each physician 
service according to the relative amount of resources involved in 
furnishing those services. There are three separate RVUs for each 
service corresponding with the relative physician work, practice 
expense, and malpractice costs associated with providing the service. 
The RVUs are converted to a dollar amount by multiplying them by a 
conversion factor.


The final rule has a statutory publication date of November 1, and 
implementation of January 1, 2006.


We explain the proposed changes to Medicare Part B physician payment 
policy. We also explain that we are proposing these changes to ensure 
that our payment systems are updated to reflect changes in medical 
practice and the relative value of services.


Summary of Legal Basis:


Section 1848 of the Social Security Act (the Act) establishes the 
payment for physician services provided under Medicare. Section 1848(b) 
(1) of the Act imposes a deadline of on later than November 1 for 
publication of the final physician fee schedule rule.


Alternatives:


None. This is a statutory requirement.


Anticipated Cost and Benefits:


We project expenditures of $56.5 billion in 2006. Including 
beneficiaries' deductible and coinsurance amounts, total payment for 
physician fee schedule services in 2006 are projected to be $74.3 
billion.


Risks:


If this regulation is not published timely, physician services will not 
be paid appropriately.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            08/08/05                    70 FR 45763
Final Action                    11/00/05

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Agency Contact:
Diane Milstead
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicare Management
7500 Security Boulevard
Baltimore, MD 21244
Phone: 410 786-3355
Related RIN: Related to 0938-AN04
RIN: 0938-AN84
BILLING CODE 4150-24-S

[[Page 64162]]




DEPARTMENT OF HOMELAND SECURITY (DHS)



Statement of Regulatory Priorities
The Department of Homeland Security (DHS or the Department) was created 
in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107-
296. DHS is comprised of 22 federal agencies brought together for the 
common mission of preventing terrorist attacks in the United States, 
reducing the vulnerability of the United States to terrorist attacks, 
and minimizing damage and assisting in recovery from attacks that might 
occur in the United States. The Department's Strategic Plan governs the 
development of DHS' strategies, programs and projects, and ultimately 
is reflected in the Department's budget and regulatory agenda. DHS' 
Strategic Plan is posted on the Department's Web site: http://
www.dhs.gov/interweb/assetlibrary/DHS--StratPlan--FINAL--spread.pdf.
DHS' Strategic Goals are:
AWARENESS-- Identify and understand threats, assess vulnerabilities, 
determine potential impacts, and disseminate timely information to our 
homeland security partners and the American public.
PREVENTION -- Detect, deter, and mitigate threats to our homeland.
PROTECTION-- Safeguard our people and their freedoms, critical 
infrastructure, property, and the economy of our Nation from acts of 
terrorism, natural disasters, or other emergencies.
RESPONSE-- Lead, manage, and coordinate the national response to acts 
of terrorism, natural disasters, or other emergencies.
RECOVERY -- Lead national, state, local, and private sector efforts to 
restore services and rebuild communities after acts of terrorism, 
natural disasters, or other emergencies.
SERVICE -- Serve the public effectively by facilitating lawful trade, 
travel, and immigration.
ORGANIZATIONAL EXCELLENCE -- Value our most important resource, our 
people. Create a culture that promotes a common identity, innovation, 
mutual respect, accountability, and teamwork to achieve efficiency, 
effectiveness, and operational synergies.
Each regulatory project outlined in the Fall Regulatory Program and the 
Unified Agenda is linked to the Department's Strategic Plan and 
departmental goals and objectives.
On July 13, 2005, the Secretary of Homeland Security announced a new 
six-point agenda to ensure that the Department's policies, operations, 
and structures are aligned in the best way to address the potential 
threats that face our nation. The Secretary's six-point agenda is 
intended to:
 Increase overall preparedness, particularly for catastrophic 
            events;
 Create better transportation security systems to move people 
            and cargo more securely and efficiently;
 Strengthen border security and interior enforcement and reform 
            immigration processes;
 Enhance information sharing with our partners;
 Improve DHS financial management, human resource development, 
            procurement and information technology; and
 Realign the DHS organization to maximize mission performance.
The regulations summarized in the Department's Fall Regulatory Program 
and in the Unified Agenda support the Secretary's six-point agenda and 
will improve the Department's ability to accomplish its primary mission 
and strategic goals.
The Department strives for organizational excellence and uses a 
centralized and unified approach in managing its regulatory resources. 
The Department's regulatory program, including the Unified Regulatory 
Agenda and Regulatory Plan, is managed by the Office of the General 
Counsel. In addition, DHS senior leadership reviews each significant 
regulatory project to ensure that the project fosters and supports the 
Department's Strategic Goals.
DHS also is committed to ensuring that all of its regulatory 
initiatives are aligned with its guiding principles to protect civil 
rights and civil liberties, integrate our actions, build coalitions and 
partnerships, develop human resources, innovate and be accountable to 
the American public. The Department values public involvement in the 
development of its Regulatory Plan, Unified Agenda and regulations, and 
takes particular concern in the impact its rules have on small 
businesses. DHS and each of its components continue to emphasize the 
use plain language in our notices and rulemaking documents to promote 
better understanding of regulations and increased public participation 
in its rulemakings.
DHS joined the Environmental Protection Agency Federal Partner On-line 
Electronic Docket System (EDocket) in September 2004. In September 
2005, EDOCKET will be replaced by the Federal Docket Management System 
(FDMS) located at www.regulations.gov. Because the Coast Guard and the 
Transportation Security Administration (TSA) originally were included 
in the Department of Transportation's (DOT) electronic Docketing 
Management System, those agencies currently remain on DOT's docket and 
their dockets continue to be accessible at dms.dot.gov. We anticipate 
that the Department, including the Coast Guard and TSA, will be fully 
migrated to FDMS during fiscal year 2006.
Office of the Secretary
The Fall 2005 Regulatory Plan for the Office of the Secretary of 
Homeland Security includes regulations sponsored by the Department's 
five major divisions or directorates: Border and Transportation 
Security; Emergency Preparedness and Response; Science and Technology; 
Information Analysis and Infrastructure Protection; and Management.\1\ 
Additionally, several DHS components are authorized to promulgate 
regulations. Those components include, but are not limited to: the 
United States Coast Guard, United States Citizenship and Immigration 
Services, the Federal Emergency and Management Agency, the Bureau of 
Customs and Border Protection, the Transportation Security 
Administration, and the Bureau of Immigration and Customs Enforcement. 
The Regulatory Plans for these DHS components are discussed separately 
below.
---------------------------------------------------------------------------
\1\ On July 13, 2005, the Secretary of Homeland Security announced a 
proposed reorganization of the Department. Pursuant to the 
reorganization, the directorates listed above may be subject to change 
during fiscal year 2006, and will be updated in the Spring Unified 
Agenda for 2006.
---------------------------------------------------------------------------
During fiscal year 2006, DHS Office of the Secretary expects to expand 
the scope of the United States Visitor and Immigrant Status Indicator 
Technology (US-VISIT) program. US-VISIT is an integrated, automated 
entry-exit system that records the arrival and departure of aliens; 
verifies aliens' identities, and authenticates aliens' travel documents 
through comparison of biometric identifiers. The goals of the US-VISIT 
program are to enhance the security of United States citizens and 
visitors to the United States, facilitate legitimate travel and trade, 
ensure the integrity of the United States immigration system, and 
protect the privacy of visitors to the

[[Page 64163]]

United States. In its early stages, US-VISIT applied only to 
nonimmigrants with visas and to those who did not require a visa as 
they were entering under the Visa Waiver Program. During 2004, the US-
VISIT program was expanded to include persons entering the United 
States under the Visa Waiver Program. For fiscal year 2006, DHS plans 
to further expand the classes of aliens that will be subject to US-
VISIT requirements to eventually encompass all aliens, with certain 
limited exceptions. DHS also is extending US-VISIT to all land border 
ports of entry and expects to make the program operational at these 
ports by December 31, 2005. This regulatory program supports the 
Department's Strategic Goals of awareness, prevention, and protection 
by securing our borders against terrorists who intend to harm the 
United States.
 DHS also expects to finalize the interim rule on Procedures for 
Handling Critical Infrastructure Information (CII). This rulemaking 
will establish uniform procedures for the receipt, care, and storage of 
CII voluntarily submitted to the Federal Government. The procedures 
apply to all Federal agencies that receive, care for, or store CII 
voluntarily submitted to the Federal Government. This rule will support 
the Department's Strategic Goals of awareness, prevention, protection, 
and response by identifying and assessing the vulnerability of critical 
infrastructure and key assets.
During fiscal year 2006, the Department intends to finalize its interim 
rule on the SAFETY ACT. The SAFETY ACT regulation implements the 
Support Anti-Terrorism by Fostering Effective Technology Act found at 
subtitle G of the Homeland Security Act of 2002 (Homeland Security 
Act). This rule would provide critical incentives for the development 
and deployment of antiterrorism technologies by providing liability 
protections for sellers of ``qualified antiterrorism technologies'' and 
others. This rule would amend the February 2004 interim rule which 
established uniform procedures to implement the Critical Infrastructure 
Information Act of 2002. These procedures govern the receipt, 
validation, handling, storage, marking and use of critical 
infrastructure information voluntarily submitted to the Department. The 
procedures are applicable to all Federal, State, local, and tribal 
government agencies and contractors that have access to, or handle, use 
or store critical infrastructure information that enjoys protection 
under the Critical Infrastructure Information Act of 2002.
United States Coast Guard
The United States Coast Guard is a military, multi-mission, and 
maritime agency. Our statutory responsibilities include ensuring marine 
safety and security, preserving maritime mobility, protecting the 
marine environment, enforcing U.S. laws and international treaties, and 
performing search and rescue. The Coast Guard supports the Department's 
overarching goal of mobilizing and organizing our nation to secure the 
homeland from terrorist attacks, natural disasters, and other 
emergencies. In performing its duties, the Coast Guard has established 
five strategic goals -- maritime safety, protection of natural 
resources, maritime security, maritime mobility and national defense. 
Each of the rulemaking projects identified for the Coast Guard in the 
Unified Agenda, and the three the rules appearing on the Fall 2005 
Regulatory Plan below, support these strategic goals and reflect our 
regulatory policies. Further, although the Coast Guard has placed an 
emphasis on maritime security and national defense since September 11, 
2001, our emphasis on these vital issues has not prevented the Coast 
Guard from carrying out its other important regulatory 
responsibilities. The Coast Guard has issued many rules that are not 
security-related -- as indicated by the wide range of topics covered in 
its 55 rulemaking projects in the final-rule, long-term actions, or 
proposed-rule stages in this Unified Agenda.
There are three rules in the Department's Fall 2005 Regulatory Plan 
that are of particular interest to the Coast Guard: (1) Marine 
Casualties and Investigations; Chemical Testing Following Serious 
Marine Incidents (Chemical Testing final rule); (2) Vessel Requirements 
for Notices of Arrival and Departure, Carriage of Automatic 
Identification System; and (3) Validation of Merchant Mariners' Vital 
Information and Issuance of Coast Guard Merchant Mariner's Licenses and 
Certificates of Registry. The Chemical Testing final rule revises the 
requirements for alcohol testing after a serious marine incident to 
comply with the 1998 Coast Guard Authorization Act, Public Law 105-383. 
This final rule modifies the drug and alcohol testing rules following a 
serious marine incident to require that alcohol testing be conducted 
within 2 hours of a serious marine incident (SMI), requires most 
commercial vessels to have alcohol testing devices on board, and 
authorizes saliva as an acceptable specimen for alcohol testing. It 
also adds a 32-hour time limit for collecting drug test specimens 
following a serious marine incident. Commercial vessels able to conduct 
alcohol testing at a shore side testing facility with two hours of a 
serious marine incident will be exempt from the requirement to carry 
alcohol-testing devices on board. This final rule comports with the 
Coast Guard strategic goal of ensuring maritime safety.
Currently, the Coast Guard does not have a mechanism to capture vessel, 
crew, passenger, or specific cargo information on vessels less than or 
equal to 300 gross tons intending to arrive at or depart from U.S. 
ports unless they are arriving with certain dangerous cargo or are 
arriving at a port or place within the 7th Coast Guard District. To 
remedy this situation, the Coast Guard is issuing ``Vessel Requirements 
for Notices of Arrival and Departure (NOAD), and Carriage of Automatic 
Identification System (AIS),'' an interim final rule that would expand 
the applicability of these requirements to better enable the Coast 
Guard to correlate vessel AIS data with NOAD data, enhance our ability 
to identify and track vessels, detect anomalies, improve navigation 
safety, and heighten our overall maritime domain awareness and 
security. This interim rule would expand the applicability of NOADs to 
include all foreign commercial vessels, regardless of tonnage, and more 
U.S. commercial vessels including all of those arriving from a foreign 
port or place. This interim rule also would expand the Coast Guard's 
AIS carriage requirements to all commercial vessels identified in the 
Maritime Transportation Act of 2002, and include vessels carrying 50 
passengers (vice the current 150 or more passengers for hire), carrying 
or towing certain dangerous cargo, certain dredges and certain high 
speed passenger craft. This rulemaking supports the Commandant's 
strategic goals of maritime safety and maritime security.
The Coast Guard interim rule ``Validation of Merchant Mariners' Vital 
Information and Issuance of Coast Guard Merchant Mariner's Licenses and 
Certificates of Registry,'' would amend the maritime personnel 
licensing rules to include new security requirements when mariners 
apply for original, renewal, and raise of grade licenses and 
certificates of registry. This rule would require all applicants for 
licenses and certificates of registry to have their identity verified 
and their fingerprints taken for a criminal records check by

[[Page 64164]]

the Coast Guard. This interim final rule has the goal of furthering all 
five of the Commandant's strategic goals.
The Coast Guard, through the rulemaking projects identified in the 
Regulatory Plan and the Unified Agenda, plans to continue to meet its 
multi-mission, regulatory obligations as reflected in its strategic and 
policy goals, the Department's goal of securing the homeland from 
terrorist attacks, and the goals of the President's Six-Point Plan for 
Economic Growth.
The Coast Guard continues to use plain language in its notices and 
rulemaking documents to promote better understanding of regulations and 
increased public participation in its rulemakings. The Coast Guard 
encourages early public involvement in this process and takes 
particular concern in the impacts its rules have on small businesses. 
It has supported the e-rulemaking initiative, and, starting on the day 
of the first Federal Register publication in a rulemaking project, the 
public can submit comments electronically and view agency documents and 
public comments on the Department of Transportation's Document 
Management System, which is available online at dms.dot.gov. The Coast 
Guard endeavors to reduce the paperwork burden it places on the public 
and strives to issue only necessary regulations that are tailored to 
impose the least burden on society.
U.S. Citizenship and Immigration Services
The United States Citizenship and Immigration Services' (USCIS) mission 
is to restore public confidence in the integrity of America's 
immigration services by making certain that those immigrant applicants 
meeting our statutory and regulatory requirements, such as those 
provided by the Immigration and Nationalization Act (INA) and its 
implementing regulations, duly receive all rights and benefits granted 
by law. USCIS accomplishes this central mission through the granting of 
immigration and citizenship benefits to qualified beneficiaries, while 
working to ensure the integrity of our immigration system overall. In 
accordance with the USCIS mission statement, USCIS' key regulatory 
initiatives for DHS' 2005 Fall Regulatory Program and Unified Agenda 
focus on eliminating the USCIS benefit application backlog and 
providing immigration-related humanitarian relief to victims of human 
trafficking and abuse.
The USCIS key regulatory initiatives that govern nonimmigrant classes 
and admission requirements focus on eliminating the backlog of 
processing pending applications and petitions. USCIS has worked 
persistently to eliminate the backlog of pending applications and 
petitions since our establishment in March 2003. Promulgation of these 
rules will help in streamlining processing procedures and the paperwork 
burden thereby improving customer service. These regulations include: 
the Removal of the Standardized Request for Evidence Processing 
Timeframe; Fingerprinting Applicants and Petitioners for Immigration 
Benefits, Establishing a Fee for Fingerprinting by the Service; 
Administrative Appeals Office: Procedural Reforms to Improve 
Efficiency; Designating the Form I-140, Immigrant Petition for Alien 
Worker, Form I-539, Application to Extend/Change Nonimmigrant Status, 
and Form I-765, Application for Employment Authorization, for Premium 
Processing Services; and Affidavits of Support on Behalf of Immigrants. 
By clarifying the standards for adjudication of various benefit 
applications and petitions, extending the timeframes for filing of 
petitions, and eliminating the need for certain employers to 
reestablish that they have met certain requirements for filing a 
petition every time a new petition is filed, USCIS is able to 
streamline its adjudication process, thus reducing its backlog through 
faster adjudication, and ultimately decreasing benefit-processing 
times.
USCIS believes that these regulatory initiatives will improve the 
processing of applications and petitions by streamlining the processes 
and thereby helping to alleviate the backlog. USCIS further believes 
that theses initiatives have appropriate safeguards to prevent fraud 
and abuse. These regulatory activities foster many of the Department's 
Strategic Goals: awareness, prevention, protection and organizational 
excellence by placing USCIS in a better position to safeguard against 
any risk that may be posed by unlawful applicants to national security 
or public safety by ensuring that documents are issued after the 
completion of required background and security checks. This initiative 
also fosters the President's Six-point Plan for Economic Growth.
USCIS also plays a distinct role in supporting the United States 
humanitarian commitment to flexible and sound immigration and refugee 
programs. To further our humanitarian protection mandate, USCIS is 
pursuing regulatory initiatives that will assist victims of human 
trafficking, abuse, and certain crimes. USCIS is working to establish 
procedures to avail these individuals of humanitarian protection that 
will allow them to remain temporarily in the United States and, in 
appropriate circumstances, to adjust to lawful permanent resident (LPR) 
status. During fiscal year 2006, USCIS will be issuing the following 
regulations in furtherance of its humanitarian mandate: New 
Classification for Victims of Certain Criminal Activity, Eligibility 
for `U' Nonimmigrant Status and Adjustment of Status for Victims of 
Trafficking.
USCIS' interim rule, ``New Classification for Victims of Certain 
Criminal Activity, Eligibility for `U' Nonimmigrant Status,'' would 
implement section 1513(b) of the Victims of Trafficking and Violence 
Protection Act of 2000, Public Law 106-386. This rule establishes 
procedures for application and issuance of `U' nonimmigrant status for 
victims of certain crimes, among them rape, torture, human trafficking, 
and domestic violence.
USCIS also will be finalizing its rule ``Adjustment of Status for 
Victims of Trafficking'' which rule enables victims of severe forms of 
trafficking in persons (`T' nonimmigrants) and victims of certain 
crimes (`U' nonimmigrants) to adjust to lawful permanent resident (LPR) 
status. Protection is made available to `T' and `U' nonimmigrants that 
can demonstrate they would suffer extreme hardship involving unusual 
and severe harm if removed from the United States. This rule 
establishes procedures, in appropriate circumstances, for them to 
adjust status to that of a lawful permanent resident.
Customs and Border Protection
Under section 403(1) of the HSA, the former-U.S. Customs Service, 
including functions of the Secretary of the Treasury relating thereto, 
transferred to the Secretary of Homeland Security. As part of the 
initial organization of DHS, the Customs Service inspection and trade 
functions were combined with the immigration and agricultural 
inspection functions and the Border Patrol and transferred into the 
Bureau of Customs and Border Protection (CBP). It is noted that certain 
regulatory authority of the United States Customs Service relating to 
customs revenue functions was retained by the Department of the

[[Page 64165]]

Treasury (see the Department of the Treasury Regulatory Plan).
CBP is the federal agency principally responsible for the security of 
our Nation's borders, both at and between the ports of entry and at 
official crossings into the United States. CBP must accomplish its 
border security and enforcement mission without stifling the flow of 
legitimate trade and travel. The primary mission of CBP is its homeland 
security mission, that is, to prevent terrorists and terrorist weapons 
from entering the United States. An important aspect of this priority 
mission involves improving security at our borders and ports of entry, 
but it also means extending our zone of security beyond our physical 
borders.
CBP also is responsible for administering laws concerning the 
importation into the United States of goods, and enforcing the laws 
concerning the entry of persons into the United States. This includes 
regulating and facilitating international trade; collecting import 
duties; enforcing U.S. trade, immigration and other laws of the United 
States at our borders; inspecting imports, overseeing the activities of 
persons and businesses engaged in importing; enforcing the laws 
concerning smuggling and trafficking in contraband; apprehending 
individuals attempting to enter the United States illegally; protecting 
our agriculture and economic interests from harmful pests and diseases; 
servicing all people, vehicles and cargo entering the U.S.; maintaining 
export controls; and protecting American businesses from theft of their 
intellectual property.
In carrying out its priority mission, CBP's goal is to facilitate the 
processing of legitimate trade and people efficiently without 
compromising security. During the past fiscal year, consistent with its 
primary mission of homeland security, CBP issued a final rule that 
requires the electronic transmission of manifest information for 
passengers and crew members onboard commercial vessels and aircraft, in 
advance of arrival and departure from the United States, and for 
crewmembers and non-crew members onboard foreign commercial air 
carriers that continue within and overfly the United States, in advance 
of departure of those flights. Submission of this manifest information 
to CBP is a necessary component of the nation's continuing program of 
ensuring aviation and vessel safety and protecting national security. 
The required information also will assist in the efficient inspection 
and control of passengers and crewmembers and will facilitate the 
effective enforcement of the customs, immigration and transportation 
security laws,
During fiscal year 2006, CBP plans to enhance homeland security further 
by issuing several other regulatory documents. All the rules discussed 
above foster DHS' Strategic Goals of awareness and prevention.
Consistent with the legislative mandate of the Intelligence Reform and 
Terrorism Prevention Act of 2004 (IRTPA) to perform vetting of 
passenger or crew information prior to the departure of an aircraft or 
vessel, CBP is working on a regulation to require transmission of 
manifest information for arriving and departing passengers and for 
departing vessel passengers and crewmembers at an earlier point in time 
than is now required.
CBP also is working with the State Department on a joint rulemaking 
initiative under section 7209 of the IRTPA, which provides that, by 
January 1, 2008, United States citizens and nonimmigrant aliens may 
enter the United States only with passports or such alternatives as the 
Secretary of Homeland Security may designate as satisfactorily 
establishing identity and citizenship. In the future, as a result of 
the implementation of the new statute, travel to the United States by 
United States citizens and others from Western Hemisphere countries, 
including Canada and Mexico, will require a passport or acceptable 
alternative documents in circumstances where travel was previously 
permitted without such documents. DHS and State jointly issued an 
advance notice of proposed rulemaking on September 1, 2005, to announce 
the travel initiative and to solicit public comments on the 
implementation of these requirements. We anticipate issuing additional 
rulemaking actions during fiscal year 2006 to begin implementation of 
the requirements under the IRTPA.
During this fiscal year, CBP also plans to issue a proposal requiring 
that all containers are adequately secured with security seals. This 
rulemaking is consistent with a mandate in the Maritime Transportation 
Security Act of 2002, to develop performance standards to enhance the 
physical security of shipping containers, including standards for seals 
and locks.
In addition to its plans to continue issuing regulations to enhance 
border security, CBP, during fiscal year 2006, expects to continue to 
issue regulatory documents that will facilitate legitimate trade and 
implement trade benefit programs. Discussion of CBP regulations 
regarding the customs revenue function is contained in the regulatory 
plan of the Department of the Treasury.
Emergency Preparedness and Response / Federal Emergency Management 
Agency
The mission of the Federal Emergency Management Agency (FEMA) is: 
``[t]o lead the Nation to prepare for, mitigate the effects of, respond 
to, and recover from major disasters and emergencies, both natural and 
man-made, including acts of terrorism.'' FEMA is charged with 
developing and maintaining an integrated, nationwide operational 
capability to respond to and recover from disasters and emergencies, 
regardless of their cause, in partnership with other Federal agencies, 
State and local governments, volunteer organizations, and the private 
sector. FEMA coordinates and implements the Federal response to 
disasters declared by the President.
During 2005, FEMA issued an interim rule to establish a mechanism to 
distributed funds collected under The 9/11 Heroes Stamp Act of 2001. 
That Act directed the United States Postal Service to issue a postal 
stamp and distribute the proceeds through FEMA to the families of 
emergency relief personnel killed or permanently disabled while serving 
in the line of duty in connection with the terrorist attacks of 
September 11, 2001. FEMA anticipates finalizing this interim rule 
during fiscal year 2006. This regulation fosters the Department's 
strategic goal of recovery by assisting the families of emergency 
relief personnel who served in the line of duty on 9/11 in rebuilding 
their lives.
Immigration and Customs Enforcement
The Bureau of Immigration and Customs Enforcement (ICE), the largest 
investigative arm of DHS, is responsible for identifying and preventing 
security vulnerabilities to the nation's border, economic, 
transportation and infrastructure. Its mission is to prevent acts of 
terrorism by targeting the people, money, and materials that support 
terrorist and criminal activities. Established to combat the criminal 
and national security threats emergent in a post 9/11 environment, ICE 
combines a new investigative approach with new resources to provide 
unparalleled investigation, interdiction and security services to the 
public and our law enforcement partners in the federal and local 
sectors.

[[Page 64166]]

During fiscal year 2006, ICE will be pursuing rulemaking actions to 
implement major components of the President's and Department's 
strategic goals. ICE will continue to promulgate regulations as 
necessary to improve control of the reporting requirements for over 
500,000 international students attending colleges and universities in 
the United States and a similar number of exchange visitors entering 
the United States through regulatory amendments to the Student Exchange 
Visitor Information System (SEVIS) and Student Exchange Visitor Program 
(SEVP). These actions will foster the Department's strategic goals of 
awareness and prevention.
In an effort to streamline the removal process of persons who no longer 
have immigration status, ICE also will promulgate an interim final rule 
that requires aliens who become subject to a final order of removal to 
surrender themselves to the ICE within 30 days thereafter. This rule 
provides that aliens who are given notice of the mandatory duty to 
surrender and later fail to comply with the surrender obligation will 
be denied all discretionary immigration benefits for the remainder of 
their presence in the U.S. and for 10 years after their departure. This 
action enhances the integrity of the removal process by shifting the 
burden upon termination of removal proceedings--eliminating the 
requirement that the ICE seek out those subject of final removal 
orders--and instead requiring that such persons present themselves for 
removal. The surrender requirement will apply to aliens who receive 
notice of the obligation in the course of their immigration proceedings 
or concurrently with the final order of removal. This regulatory 
initiative promotes the Department's strategic goals of awareness and 
prevention.
Transportation Security Administration
TSA's mission is to protect the nation's transportation systems by 
ensuring the freedom of movement for people and commerce. As we work to 
meet the immediate needs of the transportation sector, we continue to 
develop and implement the strategies, through its people, processes, 
and technology that enable us to perform our daily activities while 
ultimately preparing us for the future.
In fiscal year 2006, TSA will promote DHS' Strategic Goals of 
awareness, prevention, protection, and service by emphasizing 
regulatory efforts that allow TSA to better identify, detect, and 
protect against threats to the domestic transportation system, while 
facilitating the efficient movement of cargo and the traveling public. 
TSA is partnering with other DHS components and with other Federal, 
State, and local agencies, to achieve common objectives and assure a 
uniform and appropriate standard of transportation security for the 
benefit of the American public.
In furtherance of this goal, TSA will continue testing and begin 
implementation of the Secure Flight program, in accordance with Sec. 
4012(a)(1) of the Intelligence Reform and Terrorism Prevention Act of 
2004 (IRTPA) (Pub. L. 108-458, 118 Stat. 3638, 3714, Dec. 17, 2004). 
Through rulemaking, TSA will begin to assume from aircraft operators 
the function of comparing passenger information to the consolidated and 
integrated watch list maintained by the Federal Government.
In addition, TSA will continue development of the Registered Traveler 
(RT) program, which will allow expedited screening for passengers who 
have voluntarily submitted background information and biometric data, 
such as fingerprints or an iris scan, and have successfully undergone a 
security threat assessment.
TSA also will continue development of the Transportation Worker 
Identification Credential (TWIC) program, to be implemented by 
rulemaking, which will allow TSA to perform security threat assessments 
and issue biometric credentials to individuals requiring unescorted 
access to secure areas of transportation facilities, and thereby will 
prevent unauthorized persons from gaining access to secure areas.
Additionally, TSA continues to enhance air cargo security and the 
methods for screening of cargo through regulatory action and additional 
security programs. In appropriate instances, TSA will levy fees to 
offset all or a portion of the cost of certain security enhancements, 
such as certain background checks, and will revise the formula for 
computing the Aviation Security Infrastructure Fee (ASIF).
TSA also will propose to amend the current aviation security rules 
applicable to foreign air carriers to make them more consistent with 
the rules applicable to domestic air carriers and to add a new 49 CFR 
part 1554 regulation to improve the security of domestic and foreign 
aircraft repair stations, as required by Sec. 611(b)(1) of Vision 100 
--Century of Aviation Reauthorization Act (Pub. L. 108-176, 117 Stat. 
2490, 2571, Dec. 12, 2003).
DHS Regulatory Plan for Fiscal Year 2006
A more detailed description of the priority regulations that comprise 
DHS' Fall 2005 Regulatory Plan follows.
_______________________________________________________________________



DHS--Office of the Secretary (OS)

                              -----------

                            FINAL RULE STAGE

                              -----------




56. PROCEDURES FOR HANDLING CRITICAL INFRASTRUCTURE INFORMATION

Priority:


Other Significant


Legal Authority:


PL 107-296, 116 Stat 2135; 6 USC 131 to 134; Section 214 of The 
Homeland Security Act of 2002


CFR Citation:


6 CFR 29


Legal Deadline:


None


Abstract:


This notice of proposed rulemaking establishes the procedures necessary 
to fulfill the provisions of section 214(e) of the Critical 
Infrastructure Information (CII) Act of 2002. This regulation 
establishes uniform procedures for the receipt, care, and storage of 
CII voluntarily submitted to the Federal Government. These procedures 
apply to all Federal agencies that receive, care for, or store CII 
voluntarily submitted to the Federal Government pursuant to the CII Act 
of 2002 (6 USC 131 to 134). In addition, these procedures apply to 
United States Government contractors, to foreign, State, and local 
governments, and Government authorities, pursuant to their express 
agreements.


Statement of Need:


This final rule will establish procedures to implement section 214 of 
the CII Act of 2002 regarding the receipt, care, and storage of 
critical infrastructure information voluntarily submitted to the 
Department of Homeland Security. The protection of critical 
infrastructure reduces the vulnerability of the United States to acts 
of terrorism. The purpose of the regulation is to encourage potential 
submitters to share information pertaining to their particular and 
unique vulnerabilities, as well as those that may be systemic and 
sector-wide. As part of its

[[Page 64167]]

responsibilities under the CII Act of 2002, this information will be 
analyzed by the Department of Homeland Security to develop a more 
thorough understanding of the critical infrastructure vulnerabilities 
of the Nation. By offering the protections of the CII Act of 2002, the 
Department will ensure submitters that their information will be 
safeguarded from abuse.


Summary of Legal Basis:


This regulation is needed to finalize the interim final rule that 
implements section 214 of the Homeland Security Act by establishing 
uniform procedures for the receipt, care, and storage of critical 
infrastructure Information.


Alternatives:


The Department of Homeland Security believes that there is no 
alternative to protecting critical infrastructure information. Section 
214 of the Homeland Security Act instructs DHS to establish uniform 
procedures for the receipt, care, and storage of critical 
infrastructure information that is voluntarily submitted to the 
Government.


Anticipated Cost and Benefits:


The Department of Homeland Security had considered the costs and 
benefits in the interim final rule. The interim rule affects non-
Federal entities that have critical infrastructure information that 
they wish to share with DHS. The interim rule requires that when DHS 
receives, validates, and shares CII, DHS and the receiving parties, 
whether they are other Federal agencies or State or local governments 
with whom DHS has signed agreements detailing the procedures on how 
protected CII must be safeguarded, must take appropriate action to 
safeguard its contents. The interim rule does not require the use of 
safes or enhanced security equipment or the use of a crosscut shredder. 
Rather, the interim rule requires only that an affected entity or 
person restrict disclosure of, and access to, the protected information 
to those with a need to know, and destroy such information when it is 
no longer needed. Under the rule, a locked drawer or cabinet is an 
acceptable means of complying with the requirement to secure Protected 
Critical Infrastructure Information, and a normal paper shredder or 
manual destruction are acceptable means of destroying protected CII.


Risks:


This regulatory project will complement other DHS initiatives designed 
to detect, deter, and prevent terrorist attacks.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            04/15/03                    68 FR 18524
NPRM Comment Period End         06/16/03
Interim Final Rule              02/20/04                     69 FR 8073
Interim Final Rule 
    Effective                   02/20/04
Interim Final Rule 
    Comment Period End          05/20/04
Final Action                    05/00/06

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, Local, State


Federalism:


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


Agency Contact:
Laura Kimberly
Program Manager
Department of Homeland Security
Washington, DC 20528
Phone: 703 288-3550
Email: [email protected]
RIN: 1601-AA14
_______________________________________________________________________



DHS--OS



57. REGULATIONS IMPLEMENTING THE SUPPORT ANTITERRORISM BY FOSTERING 
EFFECTIVE TECHNOLOGIES ACT OF 2002 (THE SAFETY ACT)

Priority:


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


Legal Authority:


Safety Act, 6 USC 441 to 444


CFR Citation:


6 CFR 25


Legal Deadline:


None


Abstract:


This second interim rule implements subtitle G of title VIII of the 
Homeland Security Act of 2002--the Support of Antiterrorism by 
Fostering Effective Technologies Act of 2002 (the SAFETY Act). As 
discussed in the SAFETY Act, through regulations promulgated by the 
Department of Homeland Security (the Department), it provides critical 
incentives for the development and deployment of antiterrorism 
technologies by providing liability protections for sellers of 
``qualified antiterrorism technologies'' and others.


Statement of Need:


This regulation implements the SAFETY Act. The Department believes the 
current development of antiterrorism technologies has been slowed due 
to the potential liability risks associated with their development and 
eventual deployment. In a fully functioning insurance market, 
technology developers would be able to insure themselves against 
excessive liability risk; however, the terrorism risk insurance market 
appears to be in disequilibrium. The attacks of September 11 
fundamentally changed the landscape of terrorism insurance. Congress, 
in the findings of the Terrorism Risk Insurance Act of 2003 (TRIA), 
concluded that temporary financial assistance in the insurance market 
is needed to ``allow for a transitional period for the private markets 
to stabilize, resume pricing of such insurance, and build capacity to 
absorb any future losses.'' TRIA section 101(b)(2). This second interim 
rulemaking addresses a similar concern, to the extent that potential 
technology developers are unable to efficiently insure against large 
losses due to an ongoing reassessment of terrorism issues in insurance 
markets.


Even after a temporary insurance market adjustment, purely private 
terrorism risk insurance markets may exhibit negative externalities. 
Because the risk pool of any single insurer may not be large enough to 
efficiently spread and therefore insure against the risk of damages 
from a terrorist attack, and because the potential for excessive 
liability may render any terrorism insurance prohibitively expensive, 
society may suffer from less than optimal technological protection 
against terrorist attacks. The measures set forth in the second interim 
rule are designed to meet this goal; they provide certain liability 
protection from lawsuits and consequently will increase the likelihood 
that businesses will pursue important technologies that may not be 
pursued without this protection.


Summary of Legal Basis:


On July 11, 2003, a notice of proposed rulemaking was published 
entitled ``Regulations Implementing the Support Antiterrorism by 
Fostering Effective

[[Page 64168]]

Technologies Act of 2002 (the SAFETY Act)'' in the Federal Register (68 
FR 41420). No public hearing was requested and none was held. The first 
interim rule was published in October 2003. The Department finds that 
the need to foster antiterrorism technology by instituting liability 
protection measures, as soon as found practicable, furnishes good cause 
for this second interim rule to take effect immediately under both the 
Administrative Procedure Act, 5 U.S.C. 552(d)(3), and section 808 of 
the Congressional Review Act. The Department believes the current 
development of antiterrorism technologies has been slowed due to the 
potential liability risks associated with their development and 
eventual deployment. In a fully functioning insurance market, 
technology developers would be able to insure themselves against 
excessive liability risk; however, the terrorism risk insurance market 
appears to be in disequilibrium. The attacks of September 11 
fundamentally changed the landscape of terrorism insurance. Congress, 
in its statement of findings and purpose in TRIA, concluded that 
temporary financial assistance in the insurance market is needed to 
``allow for a transitional period for the private markets to stabilize, 
resume pricing of such insurance, and build capacity to absorb any 
future losses.'' TRIA section 101(b)(2).


Alternatives:


The Department considered public comments received on the interim rule 
and determined that another interim final rule with request for 
comments was needed.


Anticipated Cost and Benefits:


Costs and Benefits to Technology Development Firms


Since the second interim rulemaking puts in place an additional 
voluntary option for technology developers, the expected direct net 
benefits to firms of the second interim rulemaking will be positive; 
companies presumably will not choose to pursue the designation of 
``antiterrorism technology'' unless they believe it to be a profitable 
endeavor. The Department cannot predict with certainty the number of 
applicants for this program. An additional source of uncertainty is the 
reaction of the insurance market to this designation. As mentioned 
above, insurance markets appear currently to be adjusting their 
strategy for terrorism risk, so little market information exists that 
would inform this estimate. The Department invited comments on these 
issues.


If a firm chooses to invest effort in pursuing the SAFETY Act liability 
protection, the direct costs to that firm will be the time and money 
required to submit the required paperwork and other information to the 
Department. Only companies that choose to request this protection will 
incur costs. Please see the accompanying PRA analysis for an estimate 
of these costs.


The direct benefits to firms include lower potential losses from 
liability for terrorist attacks, and as a consequence a lower burden 
from liability insurance for this type of technology. In this 
assessment, we were careful to only consider benefits and costs 
specifically due to the implementation of the second interim rule and 
not costs that would have been incurred by companies absent any interim 
rulemaking. The SAFETY Act requires the sellers of the technology to 
obtain liability insurance ``of such types and in such amounts'' 
certified by the Secretary. The entire cost of insurance is not a cost 
specifically imposed by the interim rulemaking, as companies in the 
course of good business practice routinely purchase insurance absent 
Federal requirements to do so. Any difference in the amount or price of 
insurance purchased as a result of the SAFETY Act would be a cost or 
benefit of this second interim rule for firms.


The wording of the SAFETY Act clearly states that sellers are not 
required to obtain liability insurance beyond the maximum amount of 
liability insurance reasonably available from private liability sources 
on the world market at prices and terms that will not unreasonably 
distort the sales price of the seller's antiterrorism technologies. We 
tentatively concluded, however, that this second interim rulemaking 
will impact both the prices and terms of liability insurance relative 
to the amount of insurance coverage absent the SAFETY Act. The probable 
effect of the second interim rule is to lower the quantity of liability 
coverage needed in order for a firm to protect itself from terrorism 
liability risks, which would be considered a benefit of this second 
interim rule to firms. The change will most likely be a shift back in 
demand that leads to a movement along the supply curve for technology 
firms already in this market; they probably will buy less liability 
coverage. This will have the effect of lowering the price per unit of 
coverage in this market.


The Department also expects, however, that the second interim 
rulemaking will lead to greater market entry, which will generate 
surplus for both technology firms and insurers. Again, this market is 
still in development, and the Department solicits comments on exactly 
how to predict the effect of this second interim rulemaking on 
technology development.


Costs and Benefits to Insurers


The Department has little information on the future structure of the 
terrorism risk insurance market, and how this second interim rulemaking 
affects that structure we continue to consider this matter. As stated 
above, this type of intervention could serve to lower the demand for 
insurance in the current market, thus the static effect on the 
profitability of insurers is negative. Thebenefits of the lower 
insurance burden to technology firms would be considered a cost to 
insurers; the static changes to insurance coverage would cause a 
transfer from insurers to technology firms. On the other hand, this 
type of intervention should serve to increase the surplus of insurers 
by making some types of insurance products possible that would have 
been prohibitive to customers or impossible for insurers to design in 
the absence of this second interim rulemaking.


Costs and Benefits to the Public


The benefits to the public of the second interim rulemaking were very 
difficult to put in dollar value terms since its ultimate objective is 
the development of new technologies that will help prevent or limit the 
damage from terrorist attacks. It is not possible to even determine 
whether these technologies could help prevent large or small scale 
attacks, as the SAFETY Act applies to a vast range of technologies, 
including products, services, software, and other forms of intellectual 
property that could have a widespread impact. In qualitative terms, the 
SAFETY Act removes a great deal of the risk and uncertainty associated 
with product liability and in the process creates a powerful incentive 
that will help fuel the development of critically needed antiterrorism 
technologies. Additionally, we expect the SAFETY Act to reduce the 
research and development costs of these technologies.


The tradeoff, however, may be that a greater number of technologies may 
be developed and qualify for this program that have a lower average 
effectiveness against terrorist attacks than technologies currently on 
the market,

[[Page 64169]]

or technologies that would be developed in the absence of the second 
interim rulemaking. In the absence of this rulemaking, strong liability 
discouragement implies that the fewer products that are deployed in 
support of antiterrorist efforts may be especially effective, since 
profit maximizing firms will always choose to develop the technologies 
with the highest demand first. It is the tentative conclusion of the 
Department that liability discouragement in this market is too strong 
or prohibitive, for the reasons mentioned above. The Department 
tentatively concludes that this second interim rule will have positive 
net benefits to the public, since it serves to strike a better balance 
between consumer protection and technological development. The 
Department welcomes comments informing this tradeoff argument, and 
public input on whether this second interim rulemaking does strike the 
correct balance.


Risks:


The United States remains at risk to terrorist attacks. It is in the 
public's interest to have this second interim rule effective 
immediately because its aim is to foster the development and deployment 
of antiterrorism technologies. Additionally, this second interim rule 
will clarify to the greatest extent possible the application of the 
liability protections created by the SAFETY Act, thus providing an 
instant incentive for prospective applicants to apply for its 
protections and for others to begin exploring new measures that will 
prevent or reduce acts of terrorism. The second interim rule will also 
provide the Department with sufficient program flexibility to address 
the specific circumstances of each particular request for the SAFETY 
Act coverage. The application process is interactive. Those persons 
availing themselves of the protections afforded in this second interim 
rule will also be interacting with the Department in the application 
process. Furthermore, the Department will continue to consider comments 
on this second interim rule. Since the use of the liability protections 
afforded in this second interim rulemaking is voluntary, there are no 
mandatory costs or burdens associated with the immediate implementation 
of this rule.


By having these provisions in place, the Department may begin 
processing applications for the liability protections and thus provide 
qualified sellers of antiterrorism technologies valuable incentives to 
develop and sell such technologies, as well as incentives for others to 
deploy such technologies. The purpose of those technologies is to 
detect, deter, mitigate, or assist in the recovery from a catastrophic 
act of terrorism. Thus, the Department finds that it is not only 
impracticable to delay an effective date of implementation, but it is 
also in the public's interest to make the second interim rule effective 
upon publication in the Federal Register.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            07/11/03                    68 FR 41419
NPRM Comment Period End         08/11/03
Interim Final Rule              08/16/03                    68 FR 59683
Interim Final Rule 
    Effective                   10/16/03
Interim Final Rule 
    Comment Period End          12/15/03
Interim Final Rule              05/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Wendy Howe
Directorate of Science and Technology
Department of Homeland Security
Washington, DC 20528
Phone: 703 575-4511
RIN: 1601-AA15
_______________________________________________________________________



DHS--OS



58.  PROTECTION OF HUMAN SUBJECTS

Priority:


Other Significant


Legal Authority:


Not Yet Determined


CFR Citation:


None


Legal Deadline:


None


Abstract:


In conducting human subjects research, the Department is obliged to 
comply with all applicable federal statutes, regulations, guidelines, 
and standards as implemented in the law. This final rule adopts the 
Department of Health and Human Services (HHS) policies and procedures 
set forth in 45 Code of Federal Regulations (CFR) Part 46, Subparts A-D 
by cross-referencing to the HHS regulations, rather than repeating 
these identical provisions.


Statement of Need:


In December 1981, a Presidential Commission was established to report 
on the protection of human research subjects involved in biomedical or 
behavioral research. The Commission conducted a review of the various 
rules and practices of federal agencies regarding the protection of 
human subjects of biomedical or behavioral research. Among other 
suggestions, the President's Commission recommended that ``all federal 
Departments and agencies adopt as a common core the regulations 
governing research with human subjects issued by the Department of 
Health and Human Services (codified at 45 CFR part 46).``


In May 1982, affected federal agencies formed a committee to consider 
the Commission's recommendations. On June 3, 1986, the committee 
published for public comment a model policy for the protection of human 
subjects. See 51 FR 20204. Five years later, on June 18, 1991, sixteen 
federal agencies jointly set forth a common ''Federal Policy for the 
Protection of Human Subjects,`` i.e., the ``Common Rule.'' See 56 FR 
28003.


The Common Rule governs the conduct and oversight of research involving 
human subjects--it sets forth rules mandating the creation and 
maintenance of institutional review boards within agencies, establishes 
requirements for obtaining and documenting the informed consent of 
human subjects, etc. See 45 CFR part 46.


Summary of Legal Basis:


Section 8306 of the Intelligence Reform and Terrorism Prevention Act 
(IRTPA) of 2004 (Public Law 108-458) requires the Secretary of Homeland 
Security to ``ensure that the Department of Homeland Security complies 
with the protections for human research subjects, as described in part 
46 of title 45, Code of Federal Regulations, or in equivalent 
regulations.''


Alternatives:


There are no real alternatives; the agency is required by statute to 
adopt regulations consistent with the Common Rule.


Risks:


There appear to be no significant risks.

[[Page 64170]]

Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Final Rule                      01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Mark Rosen
Deputy Associate General Counsel for Science & Technology
Department of Homeland Security
Washington, DC 20528
Phone: 202 254-5627
RIN: 1601-AA29
_______________________________________________________________________



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

                              -----------

                            FINAL RULE STAGE

                              -----------




59. MARINE CASUALTIES AND INVESTIGATIONS; CHEMICAL TESTING FOLLOWING 
SERIOUS MARINE INCIDENTS (USCG-2001-8773)

Priority:


Other Significant


Legal Authority:


PL 105-383, sec 304


CFR Citation:


46 CFR 4


Legal Deadline:


None


Abstract:


This project will revise the requirements for chemical testing 
following a serious marine incident. The revision will establish 
procedures to ensure that alcohol testing be conducted within two hours 
of a serious marine incident, as required by the Coast Guard 
Authorization Act of 1998. The rule will also make additional minor 
procedural changes to the part. This rule supports the Coast Guard 
strategic goal of maritime safety.


Statement of Need:


The Coast Guard proposes changing the alcohol testing requirements for 
commercial vessels following a serious marine incident. The 1998 Coast 
Guard Authorization Act requires the Coast Guard to establish 
procedures ensuring alcohol testing is conducted within two hours of a 
serious marine casualty. The Coast Guard proposes to establish 
requirements for testing within the statutory time limits, to expand 
the existing requirements for commercial vessels to have alcohol-
testing devices on board, and to authorize use of a wider variety of 
testing devices. This rulemaking would also make additional minor 
procedural changes to part 4, including a time limit for conducting 
drug testing following a serious marine incident. This action is 
required to comply with the 1998 Coast Guard Authorization Act.


Summary of Legal Basis:


In 1998, Congress passed Public Law 105-383, which revised title 46, 
U.S. Code, by adding a new section 2303a, Post Serious Marine Casualty 
Alcohol Testing (hereafter section 2303a). Section 2303a requires the 
Coast Guard to establish procedures ensuring that after a serious 
marine casualty occurs, required alcohol testing is conducted no later 
than two hours after the casualty occurred. If the alcohol testing 
cannot be conducted within that timeframe because of safety concerns 
directly related to the casualty, section 2303a requires the alcohol 
testing to be conducted as soon thereafter as the safety concerns have 
been adequately addressed to permit such testing. However, section 
2303a prohibits us from requiring alcohol testing to be conducted more 
than eight hours after the casualty occurs.


Alternatives:


We would use the standard rulemaking process to develop regulations for 
serious marine incident alcohol testing. Nonregulatory alternatives 
such as Navigation and Vessel Inspection Circulars and Marine Safety 
Manual have been considered and may be used for the development of 
policy and directives to provide the maritime industry and our field 
offices guidelines for implementation of the regulation. Nonregulatory 
alternatives cannot be substituted for the standards being proposed 
with this rule.


Anticipated Cost and Benefits:


A cost analysis was prepared and published with the notice of proposed 
rulemaking on February 28, 2003 (67 FR 9622). The benefits of this 
action will be to ensure that alcohol tests are conducted after serious 
marine incidents so that the public will be informed whether or not 
alcohol use contributed to the incident. This action will also deter 
improper alcohol use by commercial vessel personnel.


Risks:


Under current regulations, the risk of not obtaining a valid alcohol 
test after a serious marine incident is high because specific time 
frames are not given. This action will significantly reduce the risk of 
not obtaining a valid test.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            02/28/03                     68 FR 9622
NPRM Comment Period End         06/30/03
Notice of Public Meeting; 
    Reopening of Comment 
    Period                      08/25/03                    68 FR 50992
NPRM; Reopening of 
    Comment Period              10/21/03                    68 FR 60073
Comment Period End              11/20/03
Final Rule                      11/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Local, State


Additional Information:


Transferred from RIN 2115-AG07


Formerly listed in Unified Agenda as ``Post Casualty Drug and Alcohol 
Testing''


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Robert C. Schoening
Project Manager, G-MOA-1
Department of Homeland Security
U.S. Coast Guard
2100 Second Street SW.
Room 2406
2100 Second Street SW.
Washington, DC 20593-0001
Phone: 202 267-0684
Email: [email protected]
RIN: 1625-AA27

[[Page 64171]]

_______________________________________________________________________



DHS--USCG



60. VALIDATION OF MERCHANT MARINERS' VITAL INFORMATION AND ISSUANCE OF 
COAST GUARD MERCHANT MARINER'S LICENSES AND CERTIFICATES OF REGISTRY 
(USCG-2004-17455)

Priority:


Other Significant


Legal Authority:


46 USC 2103; DHS Delegation No. 0170.1, para (92)


CFR Citation:


46 CFR 10


Legal Deadline:


None


Abstract:


This rule would impose certain security-related requirements in order 
to obtain a license or certificate of registry. Applicants would be 
required to appear in person at least once during the application 
process, to provide two acceptable forms of identification, and be 
fingerprinted by Coast Guard personnel.


Statement of Need:


A Coast Guard-issued license authorizes its holder to serve in the 
capacity of vessel's officer allowing him or her to assume positions of 
responsibility in the command and control of merchant marine vessels. 
The harm that can be caused by persons who wrongfully obtain licenses 
with the intention of committing crimes or terrorist acts jeopardizes 
mariner safety and welfare, as well as national security. Our goal is 
to protect the licensing process from abuse. We recently identified 
several omissions and ambiguities in the former rule that could 
facilitate licensing abuse. This interim rule corrects those omissions 
and clarifies those ambiguities to promote maritime safety and security 
within the United States.


Summary of Legal Basis:


In the interests of marine safety and seamen's welfare, the Coast Guard 
was given general superintendence of merchant marine personnel by 46 
U.S.C. 2103, 46 U.S.C. chapter 71, and Secretary of Homeland Security 
Delegation No. 0170.1. In 2002, Congress found that U.S. ports are 
susceptible to large-scale acts of terrorism that could cause a large 
loss of life or economic disruption, that ``ports are often a major 
locus of Federal crime,'' (Maritime Transportation Security Act of 
2002, section 101, Public Law 107-295, 116 Stat. 2064) and that it is 
in the best interest of the United States to increase port security. 
This rulemaking aligns with a similar interim rule for Merchant 
Mariner's Documents (MMD) published on 6 January 2004.


Alternatives:


We considered non regulatory alternatives such as Navigation and Vessel 
Inspection Circulars and Marine Safety Manual Guidance, however, while 
these can be used for the development of policy and directives that 
provide guidance for the implementation of a regulation, they do not 
lay a sufficient legal basis for the Coast Guard to deny issuance of 
these credentials. We considered issuing an NPRM but believe we have 
sufficient good cause to go forward with an Interim Rule.


Anticipated Cost and Benefits:


This interim rule will affect mariners who apply for licenses and CORs. 
We estimate that the annual cost of this rulemaking will be $16 
million. A detailed regulatory evaluation will be published in the 
preamble of the interim rule.


We anticipate several qualitative benefits from the new requirements 
established by this rule. All applicants for licenses and CORs will be 
required to have their fingerprints taken by Coast Guard personnel at 
an REC and will be required to have their ID checked by Coast Guard 
personnel at an REC. In the past, applicants could have had their 
fingerprints taken and their identity checked by outside entities and 
submitted them by mail without a guarantee of accuracy or validity. The 
cumulative effect of the changes in this rulemaking will be to increase 
the likelihood that the Coast Guard will process applications only 
from, and issue credentials only to, applicants who can prove they are 
who they claim to be, and whose backgrounds can be verified to make 
sure they meet security-related requirements.


Risks:


This rulemaking is intended to reduce the vulnerability of a 
transportation security incident occurring in US ports and waterways 
resulting from merchant mariners who fraudulently obtain licenses and 
CORs. These licenses and CORs could potentially be used to fraudulently 
portray ones self as a deck, engineer or staff officer.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Interim Rule                    11/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Gerald P. Miante
Project Manager, G-MSO-1
Department of Homeland Security
U.S. Coast Guard
2100 Second Street SW.
Washington, DC 20593-0001
Phone: 202 267-0221
RIN: 1625-AA85
_______________________________________________________________________



DHS--USCG



61.  VESSEL REQUIREMENTS FOR NOTICES OF ARRIVAL AND DEPARTURE, 
AND CARRIAGE OF AUTOMATIC IDENTIFICATION SYSTEM (USCG-2005-21869)

Priority:


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


Legal Authority:


33 USC 1223, 1225, 1231; 46 USC 3716, 8502 and Chapter 701; Sec. 102 of 
Pub. L. 107-295


CFR Citation:


33 CFR 160; 33 CFR 161; 33 CFR 164


Legal Deadline:


None


Abstract:


This rulemaking would expand the applicability for Notice of Arrival 
and Departure (NOAD) and Automatic Identification System (AIS) 
requirements. These expanded requirements would better enable the Coast 
Guard to correlate vessel AIS data with NOAD data, enhance our ability 
to identify and track vessels, detect anomalies, improve navigation 
safety, and heighten our overall maritime domain awareness.


The NOAD portion of this rulemaking would expand the applicability of 
the NOAD regulations by changing the minimum size of vessels covered 
below the current 300 gross tons, require that a notice of departure be 
submitted for

[[Page 64172]]

all vessels required to submit a notice of arrival, and mandate 
electronic submission of NOAD notices to the National Vessel Movement 
Center.


The AIS portion of the rulemaking would expand our AIS carriage 
requirements to all commercial vessels Congress specifically identified 
in the Maritime Transportation Security Act of 2002, and would include 
vessels carrying 50 or more passengers, vice the current 150 or more 
passengers for hire, carrying or towing certain dangerous cargo, 
certain dredges, and certain high speed passenger craft.


Statement of Need:


We do not have a current mechanism in place to capture vessel, crew, 
passenger, or specific cargo information on vessels less than or equal 
to 300 gross tons (GT) intending to arrive at or depart from U.S. ports 
unless they are arriving with certain dangerous cargo (CDC) or are 
arriving at a port in the 7th Coast Guard District. The lack of NOA 
information on this large and diverse population of vessels represents 
a substantial gap in our maritime domain awareness (MDA). We can 
minimize this gap and enhance MDA by expanding the applicability of the 
NOAD regulation beyond vessels greater than 300 GT, cover all foreign 
commercial vessels, more U.S. commercial vessels, and all U,S. 
commercial vessels coming from a foreign port; and enhance maritime 
domain awareness by tracking them (and others) with AIS. There is no 
current Coast Guard requirement for vessels to submit notification of 
departure information. In order to expand our MDA this information is 
necessary.


Summary of Legal Basis:


This rulemaking is based on Congressional authority provided in the 
Ports and Waterways Safety Act and the Maritime Transportation Security 
Act of 2002.


Alternatives:


Our goal is to increase MDA and to identify anomalies by correlating 
vessel AIS data with NOAD data. NOAD and AIS information from a greater 
number of vessels would provide even greater MDA than the proposed 
interim rule. We considered expanding NOAD and AIS to even more 
vessels, but we determined we needed additional legislative authority 
to expand AIS beyond what we propose in this rulemaking; and that it 
was best to combine additional NOAD expansion with future AIS 
expansion.


 Although not in conjunction with a proposed rule, the Coast Guard 
sought comment regarding expansion of AIS carriage to other waters and 
other vessels not subject to the current requirements (68 FR 39355-56, 
and 39370, July 1, 2003;. USCG 2003-14878). Those comments were 
reviewed and considered in drafting this rule and will become part of 
this docket.


 To fulfill our agency obligations, the Coast Guard needs to receive 
AIS reports and NOADs from vessels identified in this rulemaking that 
currently are not required to provide this information. Policy or other 
non-binding statements by the Coast Guard addressed to the owners of 
these vessels would not produce the information required to 
sufficiently enhance our MDA to produce the information required to 
fulfill our agency obligations.


Anticipated Cost and Benefits:


We expect vessel owners to incur costs from the additional NOA 
requirements in order to comply with the mandatory requirement of 
submitting notices by utilizing the Coast Guard's electronic Notice of 
Arrival and Departure (eNOAD) system.


 Currently, vessels greater than 300 gross tons, foreign commercial and 
recreational vessels less than 300 gross tons entering the 7th Coast 
Guard District, and all vessels carrying certain dangerous cargoes 
(CDCs) are required to submit NOAs.


This rulemaking will expand the applicability of NOADs to include all 
foreign commercial vessels, regardless of tonnage, more U.S. commercial 
vessels, and all U.S. commercial vessels arriving from a foreign port.


From the Coast Guard's database, we believe that we have an accurate 
estimate of the number of vessels greater than 300 gross tons 
submitting NOAs and the approximate number of voyages they make. These 
vessels are currently required to submit NOAs and will be required to 
submit NOAs/NODs through a mandatory submission method. Approximately 
20,000 vessels greater than 300 gross tons, with foreign vessels 
comprising nearly 17,000 of this amount, and U.S. vessels comprising 
the balance, are currently affected. We, however cannot at this time 
provide an estimate of the number of vessels less than 300 gross tons 
that will be affected by this rulemaking or the number of U.S. vessels 
coming from a foreign port since these vessels are not required to 
report nor do we have an effective means to capture this information. 
We will determine the affected population and include that information 
in the detailed regulatory analysis.


 For the AIS portion of this rulemaking, we expect vessel owners to 
incur costs for the installation of AIS on board vessels that do not 
currently have AIS. The vessel groups affected are all commercial self-
propelled vessels 65 feet or greater (including fishing and passenger 
vessels), towing vessels 26 feet or greater and over 600 horsepower, 
vessels carrying 50 or more passengers or certain dangerous cargoes; 
dredges and certain high speed passenger craft; operating on U.S. 
navigable waters. We estimate that the number of vessels affected by 
the AIS portion of this rulemaking is approximately 17,400 foreign and 
domestic vessels. The NOA and AIS populations will be reconciled in the 
regulatory analysis.


We anticipate unquantified benefits will be associated with both 
portions of this rulemaking. We anticipate that quantified benefits 
derived from marine casualty cases will be associated with the AIS 
portion of this rulemaking. A detailed benefit analysis will be 
included in the regulatory analysis.


Risks:


In terms of threat, vulnerability, and consequence, there are few more 
valuable and vulnerable targets for terrorist attack than the U.S. 
Maritime Transportation System (MTS). Considering the economic utility 
of U.S. ports, waterways, and coastal approaches, it is clear that a 
terrorist incident against our MTS would have a disastrous impact on 
global shipping, international trade, and the world economy. This 
rulemaking is instrumental in expansion of MDA and consequently 
instrumental in reduction of those risks posed by terrorist actions 
against the MTS.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              02/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Additional Information:


With regard to the legal deadline, we have indicated in past notices 
and rulemaking documents, and it remains the case, that we have worked 
to

[[Page 64173]]

coordinate implementation of AIS MTSA requirements with the development 
of our ability to take advantage of AIS data (68 FR 39355-56, and 
39370, July 1, 2003).


Agency Contact:
LTJG Julie Miller
Project Manager, G-MPP
Department of Homeland Security
U.S. Coast Guard
2100 Second Street SW.
Washington, DC 20593
Phone: 202 267-0069

Jorge Arroyo
Project Manager, G-MWV
Department of Homeland Security
U.S. Coast Guard
2100 Second Street SW.
Washington, DC 20593-0001
Phone: 202 267-6277
RIN: 1625-AA99
BILLING CODE 4410-10-S

[[Page 64174]]




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) 2006 highlights the Department's most significant 
regulations and policy initiatives, as established by Secretary Jackson 
for the upcoming fiscal year. HUD plays a significant role in 
communities throughout America as the federal agency responsible for 
national policy and programs that address the housing needs of 
Americans, promote community development, and enforce fair housing 
laws.
To help HUD accomplish its critical role, HUD's regulatory priorities 
for FY2006 are primarily directed to regulatory changes that will 
reduce or eliminate administrative burdens, streamline procedures, or 
establish measures directed to facilitating homeownership and improving 
access to affordable housing. HUD's regulatory priorities for FY2006 
build upon the objectives of America's Affordable Communities 
Initiative, a HUD-wide initiative devoted to removing and reducing 
regulatory barriers to affordable housing (rental or homeownership) at 
all levels of government. In June 2005, Secretary Jackson honored 14 
communities from across the nation with the Robert L. Woodson Jr. Award 
for outstanding achievements in reducing regulatory barriers and 
promoting affordable housing in these communities. From the start of 
this initiative, however, HUD has emphasized that its role is not 
merely to encourage state and local governments to remove and reduce 
regulatory barriers to affordable housing, but to examine its own 
regulations to determine whether there are HUD program requirements 
that present barriers to homeownership or affordable housing and which 
can be removed through rulemaking. In a notice published in the Federal 
Register on May 20, 2005, HUD responded to several issues raised by 
public commenters about HUD's own regulations and committed itself to 
further examination of several regulatory areas that commenters 
believed presented barriers to affordable housing.
Consistent with HUD's commitment to examine its own regulations and 
remove barriers to affordable housing, where feasible and consistent 
with the Secretary's strategic goals for FY2006, the regulations 
highlighted in this regulatory plan and in the semiannual agenda of 
regulations, published elsewhere in today's Federal Register, are 
directed to implementing policies, procedures, and programs that 
support HUD's core mission.
Priority: Promoting Economic Opportunity and Ownership
In 2004, the homeownership rate in the United States reached its 
highest level in history. Today, nearly 70 percent of American families 
own their own homes. The number of homeowners in the United States 
reached 73.4 million, the most ever. Equally impressive is that for the 
first time in history the majority of minority Americans own their own 
homes. Homeownership creates community stakeholders who tend to be 
active in their communities. It inspires civic responsibility that 
supports stable communities and raises the quality of educational 
opportunities. Homeownership's potential to create wealth is also 
impressive. A home is the largest purchase most Americans will ever 
make. It represents a tangible asset that builds equity, borrowing 
power, and overall wealth.
While much has been accomplished, much more remains to be done. HUD is 
working to accomplish the administration's goal of increasing the 
number of minority homeowners by 5.5 million by the end of the decade. 
HUD is also working to increase the supply of affordable housing by 
seven million units over the next ten years.
Regulatory Action: Government National Mortgage Association: Excess 
Yield Securities
In furthering its statutory mission of expanding affordable housing in 
America by linking domestic and global capital markets to the nation's 
housing markets, the Government NationalMortgageAssociation (Ginnie 
Mae) is developing a new Excess Yield program under which Ginnie Mae 
will guarantee Excess Yield Securities. These securities are backed by 
the excess servicing income relating to one or more mortgage pools or 
loan packages underlying previously issued Ginnie Mae mortgage-backed 
securities. The Excess Yield Program will allow qualifying Ginnie Mae 
issuers to reduce the amount of mortgage servicing rights on their 
balance sheets, which will in turn reduce the amount of capital they 
are required to hold against that asset. It will also reduce their need 
to use costly hedging tools to hedge against fluctuations in the value 
of their mortgage servicing rights. By increasing the liquidity of 
mortgage servicing rights for Ginnie Mae issuers, the Excess Yield 
Program should lower the costs of, and encourage the origination of, 
government-insured and guaranteed single-family mortgages that back 
Ginnie Mae mortgage-backed securities. This will further Ginnie Mae's 
mission and directly benefit low- and moderate-income homebuyers.
Regulatory Action: Housing Choice Voucher Program Homeownership Option: 
Eligibility of Units Not Yet under Construction
Through the Housing Choice Voucher program, HUD pays rental subsidies 
so that eligible families can afford decent, safe, and sanitary 
housing. Under the homeownership option of the Housing Choice Voucher 
program, a public housing agency (PHA) may provide voucher assistance 
for an eligible family to purchase, rather than rent, a dwelling unit 
for residence by the family. The regulations for the homeownership 
option are codified in subpart M of the Housing Choice Voucher program 
regulations at 24 CFR part 982. Under the current homeownership option 
regulations, to be eligible for purchase with voucher assistance, a 
unit must be either an existing unit or under construction at the time 
the family enters into the contract for sale. Upon reconsideration, HUD 
believes that the housing eligibility requirements may be overly 
restrictive. Consistent with its effort to expand homeownership 
opportunities, HUD will revise this regulation to permit the use of 
voucher homeownership assistance for the purchase of units not yet 
under construction at the time the family contracts to purchase the 
home. HUD believes that this change will expand homeownership 
opportunities for eligible families moving to areas of job growth, 
where such growth will frequently trigger the construction of new 
housing developments. Further, many localities have established 
affordable housing requirements on developers of new housing 
subdivisions mandating that a specified percentage of the homes to be 
constructed be set-aside for purchase by low-income families. The 
revised regulation will also permit voucher families to benefit from 
these local affordable housing initiatives prior to the construction of 
new homes.
Priority: Serving Society's Most Vulnerable
HUD remains committed to the goal of ending chronic homelessness and 
has aggressively pursued policies to move more homeless families and 
individuals

[[Page 64175]]

into permanent housing. A chronically homeless person is a person who 
suffers from a disabling developmental, physical, or mental condition 
or a substance abuse addiction; has been homeless for a year or more; 
or has had repeated periods of extended homelessness. Research 
indicates that although just 10 percent of the homeless population 
experiences chronic homelessness, these individuals consume over half 
of all emergency homeless resources. Housing this population will free 
federal, state, and local emergency resources for families and 
individuals that need shorter-term assistance. HUD is working to meet 
this goal.
Regulatory Action: Housing Opportunities for Persons With AIDS (HOPWA)
In administering this federal program, the Department has identified a 
number of corrective and technical actions that would improve the 
clarity of the program regulations in how funds are used to address the 
pressing housing needs of low-income persons who are living with HIV/
AIDS and their families. The Department will propose changes to improve 
on this partnership with the recipient States, local governments, and 
nonprofit organizations that plan, develop, operate, and evaluate the 
housing assistance and related supportive services programs in their 
areas. In HUD's view, this rule will help ensure the public trust in 
using program funds for their intended purpose in meeting the housing 
needs of eligible beneficiaries. The rule will also encourage the use 
of other mainstream health and human welfare programs for other needed 
support for residents of these housing assistance programs. In 
addition, the rule will clarify how an individual housing service plan 
would be developed to guide the assistance provided to beneficiaries in 
relation to the program's performance goals. The plans would respond to 
ongoing individual household needs and help the community develop a 
more comprehensive local assessment of the housing needs of the 
eligible population in this area. As a result, these encourage the 
efficient use of resources by determining how to best make use of HOPWA 
funds for eligible activities that support eligible households.
Priority: Making Government More Effective
Within the rulemaking process is a HUD-wide effort to reduce burdens on 
participants and program administrators by focusing on improving 
program outcomes and achieving performance goals. HUD is also aware of 
the fact that the American people demand, and are entitled to, 
government that serves as an effective steward of the taxpayer's money. 
Toward this end, HUD will reform its public housing programs to 
facilitate the transition of public housing to asset-based management 
as recommended by the congressionally mandated Harvard Cost study. That 
study, among other things, recommended that public housing agencies 
(PHAs) move to asset-based management. To facilitate this change, the 
study also recommended that HUD consolidate or remove unnecessary 
program requirements that make it difficult for PHAs to make the move 
to asset-based management. HUD is firmly committed to implementing the 
study's recommendations and providing maximum flexibility to PHAs 
within the parameters of current law to administer public housing 
programs.
HUD is also committed to overcoming regulatory barriers to affordable 
housing. HUD has determined that regulations such as out-of-date 
building codes, duplicative or time-consuming design review or approval 
processes, burdensome rehabilitation codes, restrictive or exclusionary 
zoning ordinances, unnecessary or excessive fees or taxes, and extreme 
environmental restrictions at all levels of government directly raise 
development costs in some communities by as much as 20 to 35 percent, 
thereby pricing many families and individuals out of those markets. For 
middle-income individuals such as teachers, firefighters, police 
officers, nurses, service sector employees and others, barrier removal 
is an integral component of meeting their housing needs. One of the 
goals of America's Affordable Communities Initiative is to help states 
and local governments develop comprehensive programs to remove 
regulatory barriers. Another goal is to remove public misconceptions 
about affordable housing. By educating the community and helping local 
communities remove regulatory barriers, HUD seeks to open doors for 
millions of American families who want to buy or rent an affordable 
home in the community of their choice. Through the following rules HUD 
takes additional steps in its effort to remove unnecessary barriers in 
the availability of affordable housing.
Regulatory Action: Streamlining Public Housing Programs
PHAs are required to annually submit to HUD a PHA Plan that outlines 
the their plans for the coming year. As required by section 5A of the 
United States Housing Act of 1937, these plans list 18 elements of a 
PHA's public housing and voucher programs. Among other things, HUD 
typically will not release a PHA's public housing capital funds unless 
it has approved the PHA Plan. In some instances, the PHA Plan contains 
an overview of the PHA's policy and plans for the coming five years, as 
well as the coming year.
To date, HUD has streamlined the process for submitting the PHA Plan 
for small PHAs and high-performing PHAs. HUD will expand this 
streamlining to all public housing programs in order to promote more 
effective governance and facilitate the transition to public housing 
asset-based management. HUD's intent is to more closely align public 
housing with the conventional real estate industry and to give PHAs 
maximum flexibility to administer their programs. HUD intends to remove 
procedural requirements not required by law, the elimination of which 
will allow PHAs to bring higher-income tenants into lower-income 
developments and lower-income tenants into higher-income developments, 
to avoid a concentration of low-income families as prohibited by law. 
HUD also intends to revise its regulations to more closely reflect 
statutory requirements.
Regulatory Action: Disposition of HUD-Acquired Single-Family Property
HUD is also committed to simplifying and streamlining its single-family 
property disposition regulations. In the course of doing business as a 
mortgage insurer, the Federal Housing Administration (FHA) takes 
ownership of some properties due to borrower default. When a default 
occurs, FHA lenders first try to keep the borrower in his or her home 
by pursuing loan loss mitigation. If these efforts are not successful, 
the lender forecloses on the home and conveys the property to FHA in 
exchange for payment of an insurance claim. FHA-foreclosed (real 
estate-owned (REO)) properties tend to be located in distressed 
communities, and they tend to be in relatively poor physical condition. 
The challenge for FHA is to sell these properties in a manner that 
protects the government's financial interest and has a positive impact 
on neighborhoods where REO properties are located. Over the past few 
years, FHA has explored new and innovative methods to improve its 
property disposition efforts. The regulatory changes that HUD will 
propose are based on the re-

[[Page 64176]]

procurement of management and marketing services, which provides an 
opportunity to improve business practices, management, and operating 
procedures. In reforming its property disposition program, FHA also 
intends to maintain its longstanding commitment to working with local 
governments and nonprofit organizations wishing to purchase HUD-owned 
single-family housing as part of a broader local strategy to provide 
and promote affordable housing in cities across the country. Rather 
than simply offering properties for sale on a property-by-property 
basis, HUD plans to enter into broad agreements with local governments 
that will agree to purchase all FHA-foreclosed properties within a 
specifically defined revitalization area, to be selected by both the 
local government and HUD. This will further focus federal and local 
resources on those neighborhoods most in need of public investment.
 Regulatory Action: Amendments to HUD's Environmental Regulations
HUD is committed to ensuring that its funding recipients meet their 
responsibilities under the National Environmental Policy Act (NEPA), 
related environmental statutory authority, and HUD's environmental 
regulations, 24 CFR parts 50, 51, 55, and 58. There is, however, a need 
for HUD to conform its environmental regulations to recent statutory 
enactments, specifically the Native American Housing and Self 
Determination Act (NAHASDA) and the Robert T. Stafford Disaster Relief 
and Emergency Assistance Act (Stafford Act). This new statutory 
authority permits HUD to expand certain regulatory exemptions and 
exclusions. For example, section 105(d) of NAHASDA authorizes waiving 
statutory environmental review requirements for the Indian Housing 
Block Grant program. Similarly, section 5159 of the Stafford Act allows 
an exemption from HUD's environmental review procedures for activities 
taken, or assistance provided, to substantially restore a facility to 
its condition prior to the disaster or emergency. As part of this 
effort to conform its environmental regulations to this authority, HUD 
will also review its environmental regulations to reduce administrative 
barriers and speed environmental reviews. More specifically, HUD's 
review will make its environmental regulations more user-friendly by 
removing obsolete provisions and providing other technical guidance, 
corrections, and conforming provisions.
The Priority Regulations that Comprise HUD's FY 2006 Regulatory Plan
 A more detailed description of the priority regulations that comprise 
HUD's FY 2006 Regulatory Plan follows.
_______________________________________________________________________



HUD--Office of the Secretary (HUDSEC)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




62. AMENDMENTS TO HUD'S ENVIRONMENTAL REGULATIONS (FR-4954)

Priority:


Other Significant


Legal Authority:


12 USC 1707 note; 12 USC 1715z-13a(k); 15 USC 7001 et seq; 25 USC 4115; 
25 USC 4226; 42 USC 3535(d); 42 USC 3547; 42 USC 4332; 42 USC 4852; 42 
USC 5159; 42 USC 12838; 42 USC 11331 to 11388; 42 USC 12701 to 12711; 
42 USC 12741 to 12756; 42 USC 12901 to 12912; 42 USC 12905(h); 42 USC 
1437x; 42 USC 3601 to 3619; 42 USC 4001 to 4028; 42 USC 5301 to 5315; 
42 USC 5304(g); 44 USC 101 note; 44 USC 3504 note


CFR Citation:


24 CFR 50; 24 CFR 51; 24 CFR 55; 24 CFR 58; 24 CFR 585


Legal Deadline:


None


Abstract:


This rule would make a number of revisions to HUD's environmental 
regulations to reduce administrative barriers and speed environmental 
reviews. This rule would expand HUD's regulatory waiver authority for 
certain environmental provisions where there is good cause and no 
adverse environmental impact will result. This change will allow for a 
more streamlined and user-friendly process for environmental review. 
The rule also would add an exemption to 24 CFR part 55 (floodplain 
management) for special projects directed to the removal of 
architectural barriers of properties located within floodplains. It 
would also exempt minor repairs or improvements, and special projects 
to remove architectural barriers for elderly persons and persons with 
disabilities. The rule would allow an exemption from environmental 
review procedures for an action that is taken or assistance that is 
provided to restore a facility to its condition prior to a disaster or 
emergency pursuant to section 5159 of the Robert T. Stafford Disaster 
Relief and Emergency Assistance Act. In addition, the rule would make a 
number of minor conforming changes to HUD's environmental regulations. 
Finally, the rule would request public comments on proposals to allow 
environmental submissions and notifications to be done electronically.


Statement of Need:


HUD's environmental regulations need to be conformed to current 
statutory issuances providing exceptions to review under the Native 
American Housing Assistance and Self-Determination Act (NAHASDA) and 
the Robert T. Stafford Disaster Relief and Emergency Assistance Act. 
Further, the changes made by this proposed rule would modify existing 
regulatory requirements and, therefore, must be promulgated through 
regulation.


Summary of Legal Basis:


The changes to the NAHASDA environmental regulations are made pursuant 
to 25 U.S.C. 4115(d), and the regulatory changes relating to the Robert 
T. Stafford Act are made pursuant to 42 U.S.C. 5159. In general, HUD's 
environmental regulations are under the authority of the National 
Environmental Policy Act (NEPA) 42 U.S.C. 4321 et seq.


Alternatives:


In order to revise its environmental regulations to make them more 
user-friendly and remove barriers to housing, HUD is revising its 
environmental regulations promulgated pursuant to NEPA. Doing so 
requires regulation, so there is no alternative.


Anticipated Cost and Benefits:


This rule is designed to reduce the cost of development and promote the 
production of housing by removing unnecessary procedures while 
continuing to ensure that the environment is protected.


Risks:


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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            06/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No

[[Page 64177]]

Government Levels Affected:


Local


Agency Contact:
Walter D. Prybyla
Environmental Review Division, Office of Community Planning and 
Development
Department of Housing and Urban Development
Phone: 202 708-1201
RIN: 2501-AD11
_______________________________________________________________________



HUD--Office of Housing (OH)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




63. DISPOSITION OF HUD-ACQUIRED SINGLE FAMILY PROPERTY AMENDMENTS (FR-
4952)

Priority:


Other Significant


Legal Authority:


12 USC 1710(g); 12 USC 1710(h); 12 USC 1715z to 11a; 42 USC 3535(d); . 
. .


CFR Citation:


24 CFR 291


Legal Deadline:


None


Abstract:


HUD has a variety of statutory and regulatory property disposition 
programs. In addition to sales of unoccupied HUD-held assets, these 
include the following special programs: the Asset Control Area program, 
the Dollar Home Sales to Local Governments program, the Officer and 
Teacher Next Door programs, and the single-family occupied conveyance 
program. This rule will consolidate the requirements of these various 
programs to form one integrated set of procedures for property 
disposition.


Statement of Need:


The consolidation of the various requirements for property disposition 
will make for more efficient and effective disposition of HUD-acquired 
property for HUD and the purchaser.


Summary of Legal Basis:


The National Housing Act (NHA) at 12 U.S.C. 1710(g) authorizes the 
Secretary to sell HUD-held properties ``on such terms and conditions as 
the Secretary may prescribe.'' The NHA at 12 U.S.C. 1710(h) provides 
for a specific program of asset sales for revitalization purposes in 
specified areas, known as Asset Control Areas, at a discounted price 
with a preference for sale to local governments and nonprofit 
organizations. The NHA at 12 U.S.C. 1715z-11a provides for a specific 
program of sale to local governments or community development 
corporations of ``qualified properties'' for one dollar. ``Qualified 
properties'' are unoccupied or substandard properties for which at 
least six months have elapsed since the later of the following: the 
date HUD acquired the property or the date the property was determined 
to be unoccupied or substandard.


Alternatives:


The statutes for the Asset Control Area and Dollar Home Sales to Local 
Governments programs explicitly require HUD to issue regulations. 
Further, the changes made by this proposed rule would modify existing 
regulatory requirements and, therefore, must be promulgated through 
regulation in order to have binding effect.


Anticipated Cost and Benefits:


This rule would produce a more efficient system for HUD's property 
disposition program, thus lowering the costs of holding a portfolio of 
properties and benefiting the insurance fund by maximizing the sales of 
those properties.


Risks:


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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            04/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
James Everett
Director, Asset Management Division
Department of Housing and Urban Development
Office of Housing
Phone: 202 708-1672
RIN: 2502-AI27
_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




64. HOUSING OPPORTUNITIES FOR PERSONS WITH AIDS (HOPWA) (FR-4708)

Priority:


Other Significant


Legal Authority:


42 USC 12901 et seq


CFR Citation:


24 CFR 574


Legal Deadline:


None


Abstract:


The Housing Opportunities for Persons With AIDS (HOPWA) program was 
authorized in 1990 by the AIDS Housing Opportunity Act (12 U.S.C. 12901 
et seq.) (AHOA) to provide states and localities with the programs and 
resources necessary to meet the housing needs of individuals and 
families with HIV/AIDS. The rule proposes to adjust the formula factor 
that determines the allocation of 25 percent of funds based on a 
metropolitan area's higher-than-average incidence of cases of AIDS. In 
calculating the formula allocation, the proposed change would replace 
the one-year standard for AIDS surveillance data used to determine the 
high AIDS incidence to a three-year data standard. This change is 
intended to moderate unexpected one-year increases or declines in a 
grantee's formula allocation and allow for continuity in grant funding. 
In addition, the regulation would update the HOPWA rental assistance 
requirements to make use of additional provisions and create additional 
options for grantees for operation of rental assistance programs. The 
changes would implement provisions used in other HUD programs, such as 
the Housing Choice Voucher (Section 8) program, and thereby modernize 
the HOPWA regulations, which were last updated in 1994.


Statement of Need:


This rule would help ensure the public trust in using program funds for 
their intended purpose in meeting the housing needs of eligible 
beneficiaries and by encouraging the use of other mainstream health and 
human welfare

[[Page 64178]]

programs to support residents of these housing assistance programs.


Summary of Legal Basis:


The HOPWA program was authorized by AHOA ``to provide states and 
localities with the resources and incentives to devise long-term 
comprehensive strategies for meeting the housing needs of persons with 
acquired immunodeficiency syndrome and families of such persons.'' A 
final rule was published in the Federal Register on April 11, 1994 (59 
FR 17194), establishing regulations for the implementation of this 
program at 24 CFR part 574.


Alternatives:


The changes made by this proposed rule would modify an existing 
regulatory requirement and, therefore, must also be promulgated through 
regulation. Non-regulatory alternatives (such as promulgation through a 
handbook or notice) would not be binding upon program participants.


Anticipated Cost and Benefits:


This rule will benefit persons with AIDS or related diseases who are 
low-income and their families. HOPWA funds include payments to 
individuals for small, short-term payments to prevent homelessness, 
payments of ongoing rental assistance, and the development or operation 
of supportive housing facilities, single-room occupancy dwellings, or 
community residences to meet the statutory purpose to devise long-term 
comprehensive strategies for meeting the housing needs of persons with 
AIDS.


Risks:


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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
David Vos
Director, Office of HIV/AIDS Housing
Department of Housing and Urban Development
Office of Community Planning and Development
Phone: 202 708-1934
RIN: 2506-AC11
_______________________________________________________________________



HUD--Government National Mortgage Association (GNMA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




65. GNMA: EXCESS YIELD SECURITIES (FR-4958)

Priority:


Other Significant


Legal Authority:


12 USC 1721(g); 12 USC 1723a(a); 42 USC 3535(d)


CFR Citation:


24 CFR 320


Legal Deadline:


None


Abstract:


In furthering its statutory mission of expanding affordable housing in 
America by linking domestic and global capital markets to the nation's 
housing markets, the Government National Mortgage Association (Ginnie 
Mae) is developing a new Excess Yield program under which Ginnie Mae 
will guarantee Excess Yield Securities. These securities are backed by 
the excess servicing income relating to one or more mortgage pools or 
loan packages underlying previously issued Ginnie Mae mortgage-backed 
securities. The Excess Yield program will allow qualifying Ginnie Mae 
issuers to reduce the amount of mortgage servicing rights on their 
balance sheets, which will in turn reduce the amount of capital they 
are required to hold against that asset. It will also reduce their need 
to use costly hedging tools to hedge against fluctuations in the value 
of their mortgage servicing rights. By increasing the liquidity of 
mortgage servicing rights for Ginnie Mae issuers, the Excess Yield 
program should lower the costs of, and encourage the origination of, 
government-insured and guaranteed single-family mortgages that back 
Ginnie Mae mortgage-backed securities.


Statement of Need:


The Excess Yield program is designed to further Ginnie Mae's mission 
and directly benefit low- and moderate-income homebuyers.


Summary of Legal Basis:


The Excess Yield Securities would be ``based on and backed by a trust 
or pool composed of mortgages which are insured under the National 
Housing Act'' and therefore eligible for guaranty as authorized by 12 
U.S.C. 1721(g)(1)(ii), just as their related Ginnie Mae-guaranteed 
mortgage-backed securities are. Ginnie Mae expects that the servicing 
cash flows would be pooled and would back securities guaranteed by 
Ginnie Mae and upon which Ginnie Mae would charge a guaranty fee 
pursuant to 12 U.S.C. 1721(g)(1) and 24 CFR 320 of the implementing 
regulations. The guarantee fee would be no more than six basis points, 
as required by 12 U.S.C. 1721(g)(3)(A).


Alternatives:


The alternative would be for Ginnie Mae to take no action with respect 
to excess yields, and thereby not offer Ginnie Mae issuers the choice 
of securitizing these cash flows. Retaining the status quo would make 
doing business with Ginnie Mae a less attractive option for issuers, 
thereby undercutting Ginnie Mae's mission.


Anticipated Cost and Benefits:


The Excess Yield program would make Ginnie Mae a more attractive option 
for issuers of mortgage-backed securities with minimal additional 
implementation costs.


Risks:


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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/14/05                    70 FR 54450
NPRM Comment Period End         11/14/05
Final Action                    07/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 64179]]

Agency Contact:
Stephen L. Ledbetter
Director, Securities Policy and Research
Department of Housing and Urban Development
Government National Mortgage Association
Phone: 202 401-8970
RIN: 2503-AA18
_______________________________________________________________________



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

                              -----------

                          PROPOSED RULE STAGE

                              -----------




66.  STREAMLINING PUBLIC HOUSING PROGRAMS (FR-4990)

Priority:


Other Significant


Legal Authority:


42 USC 1437c; 42 USC 1437d; 42 USC 1437e; 42 USC 1437g; 42 USC 1437r; 
42 USC 3535(d)


CFR Citation:


24 CFR 903; 24 CFR 945; 24 CFR 964; 24 CFR 966


Legal Deadline:


None


Abstract:


Public Housing Agencies (PHAs) are required annually to submit a PHA 
Plan to HUD that outlines the PHA's plans for the coming year. This 
rule would revise certain program regulations to make them more 
consistent with HUD's overall objective to streamline public housing 
programs, facilitate the transition to public housing project-based 
management, and consider recommendations of the congressionally 
mandated Harvard Public Housing Cost Study concerning changes to public 
housing's regulatory environment.


Statement of Need:


Based on the congressionally mandated Harvard Public Housing Cost 
Study, which concerned changing public housing's regulatory environment 
and HUD's goal to consolidate or remove obsolete or unnecessary program 
requirements, this proposed rule would revise several sections of HUD's 
public housing regulations in 24 CFR parts 903, 945, 964, and subpart B 
of 966. The purpose of the revisions is to streamline those regulations 
the Department believes could impede a PHA's ability to manage its 
operations within the parameters of the United States Housing Act of 
1937 (12 U.S.C. 1437 et seq.) (1937 Act). The rule also is designed to 
promote more effective governance by PHAs and provide PHAs with maximum 
flexibility, within the requirements of the 1937 Act, to design, 
manage, and operate their programs to address local needs. PHAs and 
local communities, through collaboration and partnership, are in the 
best position to create a positive living environment for their 
residents.


Summary of Legal Basis:


Section 5a of the United States Housing Act of 1937 (42 U.S.C. 1437c-
1), which provides that each PHA shall submit a plan to HUD that 
contains a mission statement and statement of goals and objectives of 
the PHA that will enable it to serve the needs of low-income and very 
low-income families, and HUD's general rulemaking authority under the 
Department of Housing and Urban Development Act, which authorizes HUD 
to establish regulatory policies and procedures governing the 
submission of a PHA's annual plan.


Alternatives:


The changes made by this proposed rule would modify an existing 
regulatory requirement and, therefore, must be promulgated through 
regulation. Non-regulatory alternatives (such as promulgation through a 
handbook or notice) would not be binding upon PHAs and other program 
participants.


Anticipated Cost and Benefits:


This rule would support HUD's overall objective to streamline public 
housing programs, facilitate the transition to public housing project-
based management, and consider recommendations of the congressionally 
mandated Harvard Cost Study. In general, this rule is directed to more 
closely align public housing with the conventional real estate 
industry, giving PHAs maximum flexibility within the parameters of 
current law to administer public housing programs. As a result, the 
rule is not anticipated to result in the imposition of new regulatory 
burdens on program participants nor significantly alter the costs 
associated with the public housing program.


Risks:


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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Patricia Arnaudo
Director, Public Housing Occupancy and Management Division
Department of Housing and Urban Development
Office of Public and Indian Housing
451 7th Street SW.
Washington, DC 20410
Phone: 202 708-0744

LaDonna Reed-Morton
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-0744
RIN: 2577-AC59
_______________________________________________________________________



HUD--PIH



67.  HOUSING CHOICE VOUCHER PROGRAM HOMEOWNERSHIP OPTION; 
ELIGIBILITY OF UNITS NOT YET UNDER CONSTRUCTION (FR-4991)

Priority:


Other Significant


Legal Authority:


42 USC 1437d; 42 USC 3535(d)


CFR Citation:


24 CFR 982


Legal Deadline:


None


Abstract:


This proposed rule would revise HUD's regulations for the homeownership 
option authorized under the Housing Choice Voucher program. Through the 
homeownership option, a public housing agency (PHA) may provide voucher 
assistance for an eligible family that purchases a dwelling unit for 
residence by the family. The current homeownership option regulations 
provide that, to be eligible for purchase with voucher assistance, a 
unit must be either an existing unit or under construction at the time 
the family

[[Page 64180]]

enters into the contract for sale. This proposed rule would permit, 
under certain conditions, the use of voucher homeownership assistance 
for the purchase of units not yet under construction at the time the 
family contracts to purchase the home. The revision will expand the 
housing choices available to families participating in the Housing 
Choice Voucher program.


Statement of Need:


The current housing eligibility requirements may be overly restrictive 
and unnecessarily prohibit voucher families from purchasing available 
affordable homes. For example, job growth in an area will frequently 
trigger the construction of new housing developments. The current 
eligibility prohibition deters voucher families from moving to such an 
area in search of employment opportunities. Further, many localities 
have established affordable housing requirements for new housing 
subdivisions mandating that a specified percentage of the homes to be 
constructed be set-aside for purchase by low-income families. The 
eligibility restriction prohibits voucher families from benefiting from 
these local affordable housing initiatives prior to the construction of 
new homes. Since few existing homes are accessible to persons with 
impaired mobility, the eligibility prohibition also has the potential 
to make it more difficult for persons with disabilities to purchase a 
home with voucher assistance.


Summary of Legal Basis:


Section 8(y) of the United States Housing Act of 1937 (42 U.S.C. 
1437f(y)), which authorizes the homeownership option, and HUD's general 
rulemaking authority under the Department of Housing and Urban 
Development Act, authorize HUD to establish regulatory policies and 
procedures governing the program, including the types of homes eligible 
for purchase with voucher homeownership assistance.


Alternatives:


The changes made by this proposed rule would modify an existing 
regulatory requirement and, therefore, must also be promulgated through 
regulation. Non-regulatory alternatives (such as promulgation through a 
handbook or notice) would not be binding upon PHAs and other program 
participants.


Anticipated Cost and Benefits:


The proposed rule is designed to benefit voucher families by expanding 
the types of housing that may be purchased with voucher assistance. The 
rule will not result in the imposition of new regulatory burdens on 
program participants, nor significantly alter the costs associated with 
the Housing Choice Voucher program.


Risks:


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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Dr. Alfred C. Jurison
Director, Housing Voucher Management and Operations Division
Department of Housing and Urban Development
Office of Public and Indian Housing
Phone: 202 708-0477
RIN: 2577-AC60
BILLING CODE 4210-01-S

[[Page 64181]]




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 500 
million acres of Federal lands, including 388 park units, 545 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, regulates surface 
coal mining operations, 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, Bureau of Land 
Management public lands, national wildlife refuges, and Bureau of 
Reclamation recreation areas. To fulfill these responsibilities, the 
Department generates scientific and other information relating to land 
and resource management.
The Department is committed to achieving its stewardship objectives in 
partnership with States, communities, landowners, and others through 
consultation, cooperation, and communication.
We will review and update the Department's regulations and policies to 
ensure that they are effective, efficient, and promote accountability. 
Special emphasis will be given to regulations and policies that:
Adopt performance approaches focused on achieving cost-effective, 
timely results;
 Incorporate the best available science, and utilize peer 
            review where appropriate;
 Promote partnerships with States, tribes, other groups, and 
            individuals;
 Provide incentives for private landowners to achieve 
            conservation goals; and
 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 significant 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. 
The collection of the fee for reclamation purposes was originally 
scheduled to expire in 1992; however, the authority to collect the fee 
has been extended several times and a further extension is anticipated.
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:
 Management of migratory birds and preservation of certain 
            marine mammals and endangered species;
 Management of dedicated lands, such as national parks, 
            wildlife refuges, and American Indian trust lands;
 Management of public lands open to multiple use;
 Leasing and development oversight of Federal energy, minerals, 
            and renewable resources;
 Management of revenues from American Indian and Federal 
            minerals;
 Fulfillment of trust and other responsibilities pertaining to 
            American Indians;
 Natural resource damage assessments; and
 Management of financial and nonfinancial assistance programs.
Regulatory Policy
How DOI Regulatory Procedures Relate to the Administration's Regulatory 
Policies
Within the requirements and guidance in Executive Orders 12866, 12630, 
and 13132, DOI's regulatory programs seek to:
 Fulfill all legal requirements as specified by statutes or 
            court orders;
 Perform essential functions that cannot be handled by non-
            Federal entities;
 Minimize regulatory costs to society while maximizing societal 
            benefits; and
 Operate programs openly, efficiently, and in cooperation with 
            Federal and non-Federal entities.
DOI bureaus work 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 decision-making 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 included:
 Increased bureau awareness of and responsiveness to the needs 
            of small businesses and better compliance with the Small 
            Business Regulatory Enforcement Fairness Act (SBREFA);
 A departmental effort to evaluate the economic effects of 
            planned rules and regulations;
 Issuance of guidance in the Departmental Manual to ensure the 
            use of plain language;
 Issuance of new guidance in the Departmental Manual to ensure 
            that National Environmental Policy Act policies that 
            streamline decision making and enhance citizen 
            participation are institutionalized;
 Issuance of revised procedures in the Departmental Manual to 
            clarify the responsibility to offer cooperating agency 
            status to qualified agencies and governments, and to make 
            clear the role of cooperating agencies in the 
            implementation of the Department's NEPA compliance process;
 In the Natural Resources Damage Assessment Program, de-
            emphasizing actions stemming from litigation while 
            increasing outreach to involved parties and stressing 
            cooperation and restoration of affected sites;

[[Page 64182]]

 A departmental effort to streamline decision-making pertaining 
            to fuels-reduction projects under the Healthy Forests 
            Initiative; and
 Joint counterpart pesticide regulations for EPA/FWS endangered 
            species consultations that will allow the agencies to work 
            together to complete the consultations (25,000 backlog) in 
            a timely and efficient manner.
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, 
waters, and facilities managed by the Department account for nearly 30 
percent of all the energy produced in the United States.
Through over 100 actions the Department is implementing the President's 
energy policy, including several regulatory actions. The Department has 
diligently completed regulatory tasks assigned to it by the NEP, 
including the Bureau of Land Management's rule that provides a 
comprehensive set of regulations for managing oil and gas leases in the 
National Petroleum Reserve B Alaska and the Minerals Management 
Service's rule that provides an incentive for development of deep gas 
resources offshore in order to encourage drilling of these high-risk 
wells that provide an important new source of natural gas supply. The 
Office of Surface Mining is developing regulations that will promote 
better mining and reclamation practices while maintaining a stable 
regulatory framework conducive to coal production. OSM anticipates that 
Congress will reauthorize the Abandoned Mine Land Fee. However, OSM has 
published 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.
The Bureau of Land Management has seen a sharp and sustained increase 
in the submission of oil and natural gas drilling permit applications. 
BLM met the challenge by initiating numerous innovative streamlining 
strategies to reduce the backlog of pending drilling permits. As BLM 
continues to make steady progress in reducing the backlog, it must work 
even more aggressively in the face of rising energy prices and 
increased demand for drilling permits. To aid in this effort, new 
process improvement tools have become available with the passage of the 
Energy Policy Act of 2005. With these tools, BLM will further reduce 
and ultimately eliminate the backlog of pending permits while allowing 
the development of energy resources in an environmentally responsible 
manner.
BLM has initiated a program of environmental Best Management Practices 
(BMPs) to help ensure the continued development of energy resources in 
an environmentally responsible manner. BMPs are innovative, dynamic, 
and improved environmental protection practices aimed at reducing 
impacts to the many natural resources BLM manages on behalf of the 
public. The BLM requires that appropriate environmental BMPs be 
considered for use in all new oil and gas drilling and production 
operations on the public lands administered by the BLM. A full 
discussion and many examples of BMPs can be found at BLM's BMP website: 
www.blm.gov/bmp
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.
Consistent with the President's Executive Order on Cooperative 
Conservation, the Department is continuing to work together with State 
and local governments, tribes, 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 in April 2004 
was a rule change intended to provide greater clarity of what is 
allowable under incidental take permits and to provide greater private 
landowner protections under safe harbor agreements.
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 conduct scientific activities on behalf of the 
Department. The Code implements 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 non-
governmental 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 National Fire 
Plan 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.
In 2002, the President announced the Healthy Forests Initiative, in 
which he directed Federal agencies to develop administrative and 
legislative tools to restore forests and woodlands to more healthy, 
natural conditions and to assist in executing core components of the 
National Fire Plan. The Healthy Forests Initiative is providing public 
land

[[Page 64183]]

managers the tools to effectively manage our forests and woodlands. The 
initiative focuses on reducing the risk of catastrophic fire by 
thinning dense undergrowth and brush in priority locations that are 
collaboratively selected by Federal, State, tribal, and local officials 
and communities. In 2005, the Department, using the administrative and 
legislative ``tools'' provided for under the Healthy Forests Initiative 
and the Healthy Forests Restoration Act, plans to satisfy National 
Environmental Policy Act requirements on over 1,300 treatments covering 
approximately 222,000 acres; to date, some 164,000 acres have been 
treated using the tools.
The National Park Service has completed an environmental assessment to 
provide for a Temporary Winter Use Plan that provides for continued 
snowmobile and snowcoach use in Yellowstone and Grand Teton National 
Parks and John D. Rockefeller, Jr. Memorial Parkway for up to the next 
three winter seasons. This EA will allow the NPS to engage in longer-
term studies and to monitor the impacts of new technology snowmobiles 
in the parks, as well as the effects of road grooming in the winter on 
bison migration in Yellowstone. The EA will require the use of cleaner, 
quieter snowmobiles and set caps on the numbers of machines allowed in 
the parks each day. The parks are working to provide a more stable 
winter use plan to help gateway communities develop a winter economic 
plan. The interim plan and longer-term studies are both intended to 
satisfy the issues raised by the Federal District Courts in Wyoming and 
the District of Columbia, respectively, that have vacated the plans 
previously completed by the NPS in 2001 and 2003.
The Bureau of Land Management is working on a grazing administration 
rule that would ensure grazing decision rules conform with the 
Administrative Procedure Act, compliance with recent court decisions 
regarding conservation use permits, require BLM to consider social and 
economic factors when considering changes to grazing use, and offer 
other improvements to grazing activities on public lands.
In December 2004, President Bush issued the Ocean Action Plan, in 
response to the US Ocean Commission Report. The Action Plan includes a 
series of proposals from across the Government that include policy 
proposals, legislative recommendations, and regulatory initiatives. DOI 
has a number of responsibilities under the Action Plan, including the 
issuance of the National Park Service's Ocean Park Strategy, the Dry 
Tortugas Management Plan and related rulemaking, creation of a National 
Water Quality monitoring network, as well as proposed legislation to 
authorize the Marine Mammal Protection Act.
The Department has submitted over a dozen proposed categorical 
exclusions provided for under NEPA to expedite a range of activities 
that the agencies routinely conduct. These range from periodic road 
closures over dams to activities related to improving Forest Health and 
energy related activities.
Minimizing Regulatory Burdens
We are using the regulatory process to improve results while easing 
regulatory burdens. 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. 
The eastern gray wolf has been delisted and an ESA section 10(j) rule 
for States with approved management plans (Idaho and Montana) was 
issued on January 6, 2005.
The Federal Power Act authorizes the Department to include in 
hydropower licenses issued by the Federal Energy Regulatory Commission 
conditions and prescriptions necessary to protect Federal and tribal 
lands and resources and to provide fishways when navigable waterways or 
Federal reservations are used for hydropower generation. As a result of 
the recently enacted energy legislation, the Administration has been 
charged with the responsibility of developing a joint rule involving 
the Departments of Agriculture, Commerce, and the Interior that 
establishes a trial- type hearing for a review of disputes over 
``material facts'' included in hydropower licenses. According to the 
law, the joint rule is to be issued within 90 days of enactment 
(approximately November 8). An interagency team has been assembled to 
develop the rule.
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, 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 completed a review of its NEPA compliance 
program and issued revised procedures aimed at improving public 
participation and reducing excess paperwork and redundancy of effort in 
the field. This has led to concrete reform measures covering 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 on how to implement the major reforms.
The Recreation Enhancement Act (REA), enacted in December 2004, 
requires that the Forest Service and BLM establish Recreation Resource 
Advisory Committees (Recreation RACs). These committees will make 
recreation fee program recommendations on implementing or eliminating 
certain recreation fees, establishing a specific recreation fee site, 
and expanding or limiting the program. REA enables the Secretaries of 
Agriculture and Interior to determine the number of Recreation RACs 
needed for effective operation of the Act. The two agencies must 
determine the appropriate number and scope of Recreation RACs so that 
the committees can effectively review fee proposals and make 
recommendations. The two agencies have worked together to identify 
possible options for Recreation RAC configurations and have held 
numerous ``listening sessions'' across the country in an effort to 
provide an opportunity to hear what people think about various options. 
The agencies are

[[Page 64184]]

currently in the process of reviewing the feedback from these sessions.
We encourage public consultation during the regulatory process. For 
example:
 OSM is continuing its outreach to interested groups to improve 
            the substance and quality of rules and, to the greatest 
            extent possible, achieve consensus on regulatory issues;
 Through a negotiated rulemaking process, the Bureau of Indian 
            Affairs has finalized its roads program rule, which 
            reflects the importance of the roads program to the 
            individual tribes and the varying needs of the tribal 
            governments;
 The Golden Gate National Recreation Area, a unit of the 
            National Park System, has engaged in negotiated rulemaking 
            to resolve an issue regarding walking dogs off-leash in the 
            park. Existing NPS regulations require all dogs to be on a 
            leash while in Golden Gate NRA, and the park has asked 
            interested parties on both sides of the issue to help draft 
            a proposed rule. On June 28, 2005, the NPS published a 
            notice in the Federal Register announcing the Secretary's 
            intent to establish a negotiated rulemaking advisory 
            committee and proposing membership for the committee.
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 
implemented this authority. It has since been extended through 2005. On 
September 13, 2005, Reclamation will publish a proposed rule that, when 
finalized, will supersede the existing public conduct rule.
Rules of Particular Interest to Small Businesses
The NPS snowmobiling rule for Yellowstone and Grand Teton National 
Parks and the John D. Rockefeller Memorial Parkway is of great interest 
to small businesses in the area of the parks, in particular those who 
rent snowmobiles. An initial Regulatory Flexibility Analysis points 
toward economic benefits to businesses in gateway communities, with 
some costs incurred by non-snowmobile users of the parks.
The NPS rules to allow personal watercraft (PWC) use are also of great 
interest to small businesses that rent or sell PWC in the vicinity of 
the 15 park units involved in the rulemakings. The rulemaking process 
has been underway for a number of years and there are currently rules 
allowing PWC use in 9 park units and rulemaking actions for 6 
additional units are in various stages of completion.
The FWS is making critical habitat designations more site-specific and 
is using the ESA section 4(b) exclusion process to reduce regulatory 
costs on small businesses. As a result of the 9th Circuit's ruling on 
``Gifford Pinchot,'' invalidating the FWS's regulatory definition of 
destruction or adverse modification of critical habitat, the Department 
is considering a rulemaking.
The BLM has developed Stewardship Contracting Guidance that provides a 
framework for the preparation, implementation, and tracking of BLM 
stewardship projects, in accordance with Section 323 of Public Law 108-
7, the Consolidated Appropriations Resolution, 2003, which authorizes 
BLM to enter into stewardship projects with private persons or public 
or private entities, by contract or by agreement, to perform services 
to achieve land management goals for the national forests or public 
lands that meet local and rural community needs. The legislation also 
authorizes the value of timber or other forest products removed to be 
applied as an offset against the cost of services received.
The Future of DOI
Interior finalized a departmental strategic plan in 2004 in response to 
Congressional, OMB and other appraisals indicating that Interior's ten 
separate strategic planning documents were too long and lacked the 
appropriate agency-level focus. The strategic plan:
 Incorporated key Administration and Secretarial priorities 
            into Interior's goals and performance measures;
 Resulted after consultation with key interested constituents 
            on the future direction of the Department; and
 Provided more ``results-oriented'' goals for Interior 
            programs.
Interior used the single Strategic Plan as the basis for preparing a 
single Departmental 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 Departmental 
strategic and annual plans to the Congress.
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 BIA's rulemaking and policy development processes 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.
Under the No Child Left Behind Act of 2001, the Secretary of the 
Interior established a negotiated rulemaking committee to develop 
proposed rules to implement several sections of the Act relating to the 
BIA-funded school system. The committee comprised representatives of 
tribes and tribally operated schools and the Federal Government. The 
tribal representative membership reflected the proportionate share of 
students from tribes served by the BIA-funded school system. This 
committee has negotiated rules to implement portions of the No Child 
Left Behind Act affecting the definition of ``Adequate Yearly 
Progress,'' attendance boundaries for BIA-funded schools, funding for 
BIA-funded schools, rights of students in the BIA-funded school system, 
and grants under the Tribally Controlled Schools Act. The final rule 
was published in the Federal Register on April 28, 2005.
Bureau of Land Management
The BLM manages about 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 
species, wilderness areas, and

[[Page 64185]]

archaeological and cultural sites. The BLM manages these lands and 
resources for multiple purposes and the sustained yield of renewable 
resources. Primary statutes under which the BLM operates include: the 
Federal Land Management and Policy Act of 1976; the General Mining Act 
of 1872; the Mineral Leasing Act of 1920, as amended; the Recreation 
and Public Purposes Act; the Taylor Grazing Act; the Wilderness Act; 
and the Wild Free-Roaming Horses and Burros Act.
The Regulatory Program mirrors statutory responsibilities and BLM 
objectives including the following:
 Supporting the objectives of the Energy Policy Act of 2005 by 
            developing regulations to facilitate the domestic 
            production of energy, including renewable energies such as 
            biomass, wind, solar, and other alternative sources of 
            energy.
 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 historic 
            resource values.
 Understanding the arid, semi-arid, arctic, and other 
            ecosystems BLM manages and its commitment to using the best 
            scientific and technical information to make resource 
            management decisions.
 Understanding the needs of the public that use the BLM-managed 
            lands and providing them with quality service.
 Committing to recover a fair return, as appropriate, for using 
            publicly owned resources and avoiding the creation of long-
            term liabilities for American taxpayers.
 Resolving problems and implementing decisions in cooperation 
            with other agencies, States, tribal governments, and the 
            public.
In preparing regulations, BLM ensures that regulations:
 Are the product of communication, coordination, and 
            consultation with all affected members of the public;
 Are easy for the public to understand, especially those most 
            affected by them; and
 Are subject to periodic review to determine whether the rules 
            are outdated, require updating to reflect statutory and 
            policy changes, and achieve desired results.
The BLM's regulatory priorities include:
 Completion of rules to facilitate implementation of the Energy 
            Policy Act of 2005 to encourage domestic production of 
            energy and other alternative and renewable sources of 
            energy;
 Finalizing the amendments to the grazing regulations to 
            improve working relationships with permittees and lessees, 
            protect the health of the rangelands, and increase 
            administrative efficiency and effectiveness.
 Finalizing the amendments to the mineral resources regulations 
            to increase many fees and to impose new fees to cover BLM's 
            costs of processing certain documents relating to its 
            minerals programs.
 Completing amendments to the recreation regulations to bring 
            them into conformance with the law, including the Federal 
            Lands Recreation Enhancement Act requirement to establish 
            Recreation Resource Advisory Committees to make fee 
            recommendations.
Most of BLM's regulations affect small businesses because many entities 
that operate on public lands meet the definition of a small business, 
as established by the Small Business Administration. BLM's regulations 
do not specifically target small businesses, and the BLM strives to 
ensure that its regulations do not unduly burden entities regardless of 
size.
Currently, BLM's mining and grazing projects often generate the 
greatest concern to small businesses because most livestock operators 
and mining companies are also considered small businesses, as 
classified by the SBA.
The final grazing rule that BLM intends to publish before the end of 
the calendar year will amend grazing regulations that BLM promulgated 
on February 22, 1995 (59 FR 29206). The final rule will not 
substantively change the existing rules. When published, the rule will 
rely on the regulatory flexibility analysis prepared by BLM for the 
1995 final rule. At that time, BLM determined that the 1995 rule should 
not have a significant impact on a substantial number of small 
entities.
The BLM will issue a final rule to amend its mineral resources 
regulations to increase certain fees and to impose new fees to cover 
BLM's costs of processing documents relating to its minerals programs. 
BLM based these fee changes on statutory authorities, which authorize 
BLM to charge for processing costs, and on policy guidance requiring 
BLM to charge these fees. This rule responds to recommendations issued 
in audit reports by the DOI's Office of Inspector General. The final 
rule also reflects changes to the proposed rule required by the Energy 
Policy Act of 2005. Applicants for BLM authorizations are the primary 
beneficiaries of those authorizations. As such, the primary benefit of 
the rulemaking is to shift the cost of processing the affected 
applications from the taxpayer to the applicant.
Minerals Management Service
The Minerals Management Service (MMS) has two major responsibilities. 
The first, administered by the Minerals Revenue Management program 
(MRM), is timely and accurate collection, distribution, accounting for, 
and substantiating of revenues associated with mineral production from 
leased Federal and Indian lands. The second, administered by the 
Offshore Minerals Management program (OMM), 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. Both of 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.
The MMS regulatory philosophy is to develop clear, enforceable rules 
that support the missions of each program.
This year, through MRM, MMS published a final Federal Gas Valuation 
Rule on March 10, 2005 and in late 2005, MMS plans to publish a 
proposed rule for Indian Oil Valuation. The Federal Gas Valuation rule 
established what transportation deductions are allowed in determining 
royalties. The Indian Oil Valuation rule will establish value for oil 
produced from wells on Indian lands. These two rules will benefit the 
government and citizens by establishing clear rules to determine 
royalties for gas produced from Federal lands and oil produced from 
Indian lands. Clear rules will reduce the number of disputes and lower 
costs to the Government of collecting royalties. Furthermore, they 
support the mission of MMS by promoting timely and accurate collection 
of royalties from Federal and Indian mineral leases.
Through OMM, MMS published a proposed rule on March 15, 2005 to recover 
costs for certain services it provides to the oil and gas industry.

[[Page 64186]]

MMS expects to publish a final rule and an additional proposed rule on 
cost recovery before the end of the calendar year. These rulemakings 
implement the President's policy as outlined in OMB Circular 25 that 
when a service provides special benefits to an identifiable recipient 
beyond those that accrue to the general public, the Federal Government 
should impose a charge to recover the cost of providing the service. 
The Department mirrors this policy (330 DM 1.3A). MMS also published 
through OMM final rules to provide further guidance on deep gas royalty 
relief (April 29, 2005) and rules that incorporate industry safety 
standards for pressure vessels (February 14, 2005) and floating 
production facilities (July 19, 2005). Additionally, MMS plans to issue 
final rules in 2005 that will clarify plans and information that 
industry must provide MMS related to exploration and production of oil 
and gas on the Outer Continental Shelf. MMS is also preparing a 
proposed rule on non-discriminatory access to pipelines. These rules 
support the mission of MMS to manage the resources in the Outer 
Continental Shelf in a manner that provides for safety, protection of 
the environment, and conservation of natural resources.
On July 29, 2005, Congress enacted energy legislation that may affect 
the MMS regulatory plan. In particular, Congress provided incentives 
for drilling ultra-deep wells in the Outer Continental Shelf, royalty 
relief for marginal wells, and established authority for the Department 
to regulate alternate sources of energy from the Outer Continental 
Shelf. Alternate sources of energy include wind farms. Congress 
directed the Secretary to promulgate regulations implementing the 
legislation. In compliance with the direction from Congress, MMS has 
added to its regulatory plan a proposed rule to implement royalty 
incentives for natural gas production from deep wells in the shallow 
waters of the Gulf of Mexico and offshore Alaska.
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 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.
OSM has sought to develop and maintain a stable regulatory program for 
surface coal mining that is safe, cost effective, and environmentally 
sound. A stable regulatory program provides regulatory certainty so 
that coal companies know what is expected of them and citizens know 
what is intended and how they can participate. During the development 
and maintenance of its program, OSM has recognized the need to (a) 
respond to local conditions, (b) provide flexibility to react to 
technological change, (c) be sensitive to geographic diversity, and (d) 
eliminate burdensome recordkeeping and reporting requirements that over 
time have proved unnecessary to ensure an effective regulatory program.
OSM's major regulatory objectives for 2006 include:
 Maintaining regulatory certainty so that coal companies know 
            what is expected of them and citizens know what is intended 
            and how they can participate;
 Ensuring an affordable, reliable energy supply while 
            protecting the environment;
 Continued consultation, cooperation, and communication with 
            interested 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; and
 Completion of ongoing rulemaking initiatives resulting from 
            litigation by the coal industry and environmental groups, 
            efforts by OSM to address areas of concern that have arisen 
            during the course of implementing its regulatory program, 
            and legislative requirements.
U.S. Fish and Wildlife Service
The mission of the U.S. Fish and Wildlife Service is to work with 
others to conserve, protect, and enhance fish, wildlife, and plants and 
their habitats for the continuing benefit of the American people. Four 
principal mission goals include:
The sustainability of fish and wildlife populations. FWS conserves, 
protects, restores, and enhances fish, wildlife, and plant populations 
entrusted to its care. FWS carries out this mission goal through 
migratory bird conservation at home and abroad; native fisheries 
restoration; recovery and protection of threatened and endangered 
species; prevention and control of invasive species; and work with our 
international partners.
Habitat conservation through a network of lands and waters. Cooperating 
with others, FWS strives 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. The FWS's 
habitat conservation strategy focuses on the interaction and balance of 
people, lands and waters, and fish and wildlife through an ecosystem 
approach.
Public use and enjoyment. FWS provides opportunities to the public to 
enjoy, understand, and participate in the use and conservation of fish 
and wildlife resources. The Service directs activities on national 
wildlife refuges and national fish hatcheries that increase 
opportunities for public involvement with fish and wildlife resources. 
Such opportunities include hunting, fishing, wildlife observation and 
photography, and environmental education and interpretation, as well as 
hands-on experiences through volunteer conservation activities on FWS-
managed lands.

[[Page 64187]]

Partnerships in natural resources. FWS supports and strengthens 
partnerships with tribal, State, and local governments and others in 
their efforts to conserve and enjoy fish, wildlife, and plants and 
habitats, consistent with the President's Executive Order on 
Cooperative Conservation. FWS administers Federal grants to States and 
territories for restoration of fish and wildlife resources and has a 
continuing commitment to work with tribal governments. FWS also 
promotes partnerships with other Federal agencies where common goals 
can be developed. The Service carries out these mission goals through 
several types of regulations. While carrying out its responsibility to 
protect the natural resources entrusted to its care, FWS works 
continually with foreign and State governments, affected industries and 
individuals, and other interested parties to minimize any burdens 
associated with its activities. In carrying out its assistance 
programs, the Service administers 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.
FWS enforces regulations that govern public access, use, and recreation 
on 545 national wildlife refuges and in national fish hatcheries. The 
Service authorizes only uses 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.
FWS administers regulations to manage migratory bird resources. 
Annually, the Service issues a regulation on migratory bird hunting 
seasons and bag limits that is developed in partnership with the 
States, tribal governments, and the Canadian Wildlife Service. These 
regulations are necessary to permit migratory bird hunting that would 
otherwise be prohibited by various international treaties.
Finally, FWS implements regulations under the Endangered Species Act 
(ESA) to fulfill its statutory obligation to identify and conserve 
species faced with extinction and to conserve certain mammals under the 
Marine Mammal Protection Act. The ESA dictates that the basis for 
determining endangered and threatened species must be 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 the continued existence of 
endangered or threatened species 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 
reviewing guidance for designation of critical habitat. The guidance 
will provide policy direction and a process for developing critical 
habitat designations.
Section 4(f)(1) of the ESA directs the Secretary of the Interior to 
develop and implement plans (known as recovery plans) for the 
conservation and survival of endangered and threatened species. The 
Service has been coordinating with the National Marine Fisheries 
Service to revise the joint Recovery Planning Guidance for the recovery 
of endangered and threatened species under the ESA. The purpose of the 
proposed guidance is to achieve greater consistency in the 
implementation of the ESA while working with partners. In addition, 
section 6 of the ESA pertains to cooperation with the States in the 
conservation of endangered and threatened species. The Department will 
also issue guidance to facilitate better coordination with the States 
and provide more opportunities for the States' direct involvement in 
managing endangered and threatened species.
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 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; nationwide outdoor recreation 
coordination and information, and State comprehensive outdoor 
recreation planning; planning and technical assistance for the National 
Wild and Scenic Rivers System, the National Trails System, natural area 
programs, the National Register of Historic Places, national historic 
landmarks, historic preservation, technical preservation services, 
Historic American Buildings Survey; Historic American Engineering 
Record; Historic American Landscapes Survey; and interagency 
archeological services.
The National Park Service maintains regulations that help manage public 
use, access, and recreation in units of the National Park System. The 
Service provides visitor and resource protection to ensure public 
safety and prevent derogation of resources. The regulatory program 
develops and reviews regulations, maintaining consistency with State 
and local laws, to allow these uses only if they are compatible with 
the purpose for which each area was established.
Bureau of Reclamation
The Bureau of Reclamation's mission is to manage, develop, and protect 
water and related resources in an environmentally and economically 
sound manner in the interest of the American public. To accomplish this 
mission, Reclamation applies management, engineering, and scientific 
skills that result in effective and environmentally sensitive 
solutions.
Reclamation projects provide for some or all of the following 
concurrent purposes: Irrigation water service, municipal and industrial 
water supply, hydroelectric power generation, water quality 
improvement, groundwater management, fish and wildlife enhancement, 
outdoor recreation, flood

[[Page 64188]]

control, navigation, river regulation and control, system optimization, 
and related uses. Reclamation has increased security at its facilities 
and is implementing its law enforcement authorization received in 
November 2001.
Reclamation's regulatory program is designed to ensure that its mission 
is carried out expeditiously, efficiently, and with an emphasis on 
cooperative problem solving.
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 appropriate restoration for injury to 
natural resources caused by hazardous substances. The Restoration 
Program is overseeing the establishment of the Natural Resources Damage 
Assessment and Restoration Program Advisory Committee that will provide 
advice and recommendation on DOI's authorities and responsibilities, 
including its responsibility to promulgate regulations in the 
implementation of the National Resource Damage provisions of CERCLA.
_______________________________________________________________________



DOI--Minerals Management Service (MMS)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




68. VALUATION OF OIL FROM INDIAN LEASES

Priority:


Other Significant


Legal Authority:


25 USC 2101 et seq; 25 USC 396 et seq; 25 USC 396a et seq; 30 USC 1701 
et seq


CFR Citation:


30 CFR 206


Legal Deadline:


None


Abstract:


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


Statement of Need:


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


Summary of Legal Basis:


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


Alternatives:


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


Anticipated Cost and Benefits:


We estimate compliance with this rulemaking would cost the oil industry 
approximately $5.4 million the first year and $4.9 million each year 
thereafter. These estimates include the up-front computer programming 
and other administrative costs associated with processing the new form. 
The monetary benefits of this rulemaking are an estimated $4.7 million 
increase in annual royalties collected on oil produced from Indian 
leases. Additional benefits include simplification and increased 
certainty of oil pricing, reduced audit efforts, and reduced valuation 
determinations and associated litigation.


Risks:


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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           12/20/95                    60 FR 65610
NPRM                            02/12/98                     63 FR 7089
NPRM Comment Period 
    Extended                    04/09/98
NPRM Comment Period End         05/13/98
Comment Period Extended 
    to 03/20/2000               02/28/00                    65 FR 10436
Supplemental NPRM               11/00/05
Supplemental NPRM Comment 
    Period End                  01/00/06

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Tribal


Agency Contact:
Sharron Gebhardt
Regulatory Specialist
Department of the Interior
Minerals Management Service
MS 302B2, P.O. Box 25165
Denver, CO 80225-3211
Phone: 303 231-3211
Fax: 303 231-3385
Email: [email protected]
Related RIN: Previously reported as 1010-AC24
RIN: 1010-AD00

[[Page 64189]]

_______________________________________________________________________



DOI--MMS



69.  RELIEF OR REDUCTION IN ROYALTY RATES - NEW DEEP GAS AND 
OFFSHORE ALASKA PROVISIONS

Priority:


Other Significant


Legal Authority:


43 USC 1331 et seq.


CFR Citation:


30 CFR 203


Legal Deadline:


Final, Statutory, February 3, 2006.


Abstract:


This proposed rulemaking would implement royalty incentives for natural 
gas production from deep wells in the shallow waters of the Gulf of 
Mexico and would authorize royalty relief for offshore Alaska as 
mandated by the Energy Policy Act of 2005 (the Act). The Act requires 
the deep gas incentives to be effective by February 3, 2006. The Alaska 
royalty suspension does not have a set date.


Statement of Need:


This rule would comply with statutory directives to enhance domestic 
oil and gas supply by adding new production incentives. A royalty 
suspension volume of 35 BCF would be created for gas produced from 
ultra deep (20,000 feet or more subsea) wells on shallow water leases 
in the Gulf of Mexico (See section 344(a) of the Act). The existing 
royalty suspension volumes and supplements plus the new ultra deep gas 
incentive would be extended to leases in the Gulf located in water 
depths between 200 and 400 meters of water (See section 344(b) of the 
Act). The Act makes pre-production royalty relief available to leases 
offshore Alaska when MMS determines it is necessary to promote 
development, increased production, or production of marginal resources 
(See section 346 of the Act). The rule would clarify how MMS would 
determine when royalty relief is appropriate.


Summary of Legal Basis:


The legal basis for rule is the Outer Continental Shelf Lands Act, 43 
U.S.C. 1331 et seq. as amended by the Energy Policy Act of 2005.


Alternatives:


There are no alternatives. Congress has mandated these two incentives. 
Therefore MMS must publish a rule to implement the Congressional 
direction.


MMS will include both incentives in a single rulemaking to reduce the 
administrative burden on the government as well as the public in its 
review and comment.


Anticipated Cost and Benefits:


Notification requirements by claimants for deep gas relief are 
insignificant relative to the benefits they will receive. The royalty 
relief provisions will provide significant benefits to claimants.


Risks:


No risks have been identified.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            11/00/05
Final Rule                      01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Kumkum Ray
Geologist
Department of the Interior
Minerals Management Service
381 Elden Street
Herndon, VA 20170
Phone: 703 787-1604
Fax: 703 787-1093
Email: [email protected]
RIN: 1010-AD31
_______________________________________________________________________



DOI--Office of Surface Mining Reclamation and Enforcement (OSMRE)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




70. PLACEMENT OF EXCESS SPOIL

Priority:


Other Significant


Legal Authority:


30 USC 1201 et seq


CFR Citation:


30 CFR 701; 30 CFR 773; 30 CFR 780; 30 CFR 781; 30 CFR 785; 30 CFR 816; 
30 CFR 817


Legal Deadline:


None


Abstract:


This rule will establish permit application requirements and review 
procedures for applications that propose to place excess spoil from 
surface coal mining operations into waters of the United States. In 
addition, it will modify the backfilling and grading regulations to 
minimize the creation of excess spoil and it will revise the 
regulations governing surface coal mining operations within 100 feet of 
a perennial or intermittent stream to more closely track the underlying 
statutory provisions.


Statement of Need:


This rule will modify the backfilling and grading regulations to 
minimize the creation of excess spoil and it will revise the 
regulations governing surface coal mining operations within 100 feet of 
a perennial or intermittent stream to more closely track the underlying 
statutory provisions.


Summary of Legal Basis:


General rulemaking authority: Section 201(c)(2) of the Surface Mining 
Control and Reclamation Act of 1977 (SMCRA), 30 U.S.C. 1211(c)(2), 
directs the Secretary of the Interior (the Secretary), acting through 
OSM, to publish and promulgate such rules and regulations as may be 
necessary to carry out the purposes and provisions of SMCRA.


Excess Spoil rulemaking authority: Section 515(b)(3) of SMCRA, 30 
U.S.C. 1265(b)(3)) requires that all surface coal mining and 
reclamation operations backfill, compact (if necessary to ensure 
stability and to prevent leaching of toxic materials), and grade to 
restore the approximate original contour of the land unless an 
alternative post mining land use requires a level or gently rolling 
contour. The provision also provides for exceptions to this requirement 
stating that there are situations when it may not be possible to return 
all the spoil to the mined area, particularly if the volume of 
overburden is large relative to the thickness of coal. In those 
situations, the operator is required to demonstrate that due to 
volumetric expansion the amount of overburden and other spoil and waste 
material is more than sufficient restore the approximate original 
contour. The operator is also required to backfill, grade, and compact 
(where advisable) any excess overburden and other spoil and waste 
material to obtain the lowest possible grade but not more than the 
angle of repose in order to achieve an ecologically sound land use 
compatible

[[Page 64190]]

with the surrounding region and to prevent slides, erosion and water 
pollution.


Section 515(b)(22) of SMCRA, 30 U.S.C. 1265(b)(22) imposes specific 
controls for the disposal of excess spoil to assure mass stability and 
to prevent mass movement and erosion. Among the various controls, 
section 515(b)(22)(D) requires that the excess spoil disposal area 
should not contain springs, natural water courses, or wet weather seeps 
unless lateral drains are constructed from the wet areas to the main 
underdrain. Section 515(b)(22)(I) requires that all other related 
provisions of SMCRA be met.


Section 515(b)(21), 30 U.S.C. 1265(b)(21), requires the protection of 
offsite areas from slides and damage by among other requirements not 
depositing spoil material outside the permit area.


Special requirements for spoil handling are also provided for those 
surface coal operations located in steep slope areas. Section 
515(d)(1), 30 U.S.C. 1265(d)(1), requires, ``no ... spoil material ... 
be placed on the downslope below the mine bench or mining cut: 
Provided, That spoil material in excess of that required for the 
reconstruction of the approximate original contour under the provisions 
of paragraph 515(b)(3) or 515(d)(2) shall be permanently stored 
pursuant to section 515(b)(22).``


Stream Buffer Zone rulemaking authority: Section 515(b)(10) of SMCRA, 
30 U.S.C 1265(b)(10), requires coal operations to minimize the 
disturbances to the prevailing hydrologic balance at the mine-site and 
in associated offsite areas and to the quality and quantity of water in 
surface and ground water systems both during and after surface coal 
mining operations and during reclamation. Section 515(b)(10)(B)(i) 
specifies that coal operations must prevent, to the extent possible 
using the best technology currently available, additional contributions 
of suspended solids to streamflow, or runoff outside of the permit area 
but in no event shall the contributions be in excess of requirements 
set by applicable State or Federal law.


Section 515(b)(24) of SMCRA, 30 U.S.C. 1265(b)(24), requires that coal 
operations use best technology currently available to minimize 
disturbances and adverse impacts on fish, wildlife, and related 
environmental values; and enhance such resources where practicable.


Alternatives:


Alternatives being considered include:


A. ``No Action'' Alternative


This alternative would result in no changes to the excess spoil and 
stream buffer zone regulations as they currently exist in the Federal 
program.


B. Strengthening the Excess Spoil Requirements


We are considering changes to the excess spoil regulations that would 
add the following: Require the applicant to demonstrate that the volume 
of excess spoil generated has been minimized, that fills would be no 
larger than necessary, and to submit alternative spoil disposal plans 
in order to identify the plan that minimizes adverse environmental 
effects.


C. Clarifying the Stream Buffer Zone Requirements


We are considering revising the stream buffer zone regulation at 30 CFR 
816.57 and 817.57 to clarify under which circumstances the regulatory 
authority can allow surface coal mining activities within 100 feet of 
an intermittent or perennial stream. We will consider a clarification 
that would closely follow our historic interpretation and 
implementation of the current stream buffer zone rule.


Anticipated Cost and Benefits:


It is anticipated that some of the regulatory changes will result in an 
increase in the costs and burdens placed on coal operators and on some 
primacy states. Preliminary estimates indicate that the total annual 
increase for operators would be approximately $240,000, and for the 
primacy states the total annual increase is estimated at approximately 
$25,000. These increases are due to the requirement to document the 
analyses and findings required by the regulatory changes. This 
estimated increase in costs would likely only affect those coal 
operators and states (Kentucky, Virginia, and West Virginia) located in 
the steep slope terrain of the central Appalachian coalfields, where 
the bulk of excess spoil is generated. Because all of the regulatory 
agencies in the Appalachian coalfields have implemented policies to 
minimize the volume of excess spoil, no significant additional costs of 
implementing these regulatory changes are anticipated other than those 
required to document the strengthened requirements to consider all 
alternative excess spoil construction and disposal sites.


One of the primary benefits of the rule is an expected reduction in the 
placement of excess spoil with resulting positive environmental 
consequences. The rule is also expected to clarify mining requirements 
for steep slop and mountaintop mining operations in Appalachia and 
thereby establish regulatory certainty for the coal industry which has 
been hesitant to expend large sums of money on this type of mining 
operations because of legal uncertainty.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            01/07/04                     69 FR 1036
Second NPRM                     06/00/06

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Dave Hartos
Physical Scientist
Department of the Interior
Office of Surface Mining Reclamation and Enforcement
Three Parkway Center
Pittsburgh, PA 15220
Phone: 412 937-2902
Email: [email protected]
RIN: 1029-AC04
_______________________________________________________________________



DOI--Bureau of Land Management (BLM)

                              -----------

                            FINAL RULE STAGE

                              -----------




71. GRAZING ADMINISTRATION--EXCLUSIVE OF ALASKA

Priority:


Other Significant


Legal Authority:


43 USC 1181d; 43 USC 1740; 43 USC 315; 43 USC 315a to 315r


CFR Citation:


43 CFR 4100


Legal Deadline:


None


Abstract:


This rule will ensure that BLM documents its consideration of the 
social, cultural, environmental, and economic consequences of grazing 
changes; provide that changes in grazing use will be phased in under 
certain circumstances; allow BLM to

[[Page 64191]]

share title with permittees and lessees to range improvements in 
certain circumstances; make clear how BLM will authorize grazing if a 
BLM decision affecting a grazing permit is stayed pending 
administrative appeal; remove provisions in the present regulations 
concerning conservation use grazing permits; ensure adequate time for 
developing and successfully implementing an appropriate management 
action when BLM finds that rangelands do not meet standards and 
guidelines for rangeland health and that authorized grazing is a 
significant factor in not achieving one or more land health standards 
or not conforming with guidelines for grazing administration; and 
revise some administrative service charges.


Statement of Need:


This rulemaking is necessary to contribute to improving working 
relationships with permittees and lessees, protecting the health of the 
rangelands, and increasing administrative efficiency and effectiveness.


Summary of Legal Basis:


The primary laws that govern grazing on public land are the Taylor 
Grazing Act (TGA) of 1934, the Federal Land Policy and Management Act 
(FLPMA) of 1976, and the Public Rangelands Improvement Act (PRIA) of 
1978.


TGA directs that occupation and use of the range be regulated to 
preserve the land and its resources from destruction or unnecessary 
injury, and to provide for the orderly use, improvement, and 
development of the range. FLPMA provides authority and direction for 
managing the public lands on the basis of multiple use and sustained 
yield and mandates land use planning principles and procedures for the 
public lands. PRIA defines rangeland as public lands on which there is 
domestic livestock grazing or which are determined to be suitable for 
livestock grazing, establishes a national policy to improve the 
condition of public rangelands so they will become as productive as 
feasible for all rangeland values, requires a national inventory of 
public rangeland conditions and trends, and authorizes funding for 
range improvement projects.


Alternatives:


The draft environmental impact statement (DEIS) on the proposed rule 
considered two alternatives in addition to the rule as proposed. The 
first alternative to the proposed rule considered in the DEIS was to 
continue to operate under the existing regulations. The existing 
regulations contain provisions that have been found unlawful by the 
Federal courts. They also do too little to promote cooperation between 
BLM and grazing permittees and lessees. They are also ambiguous at 
times and hard to understand.


The DEIS also considered a modified alternative with different 
approaches to several provisions in the proposed rule. BLM would have 
more discretion in phasing in changes in grazing use, be limited to 
five consecutive years in approving nonuse, and have discretion to use 
range assessments or monitoring or both to determine whether grazing 
management is achieving standards and conforming with guidelines. The 
alternative would include a prohibition of failing to comply with weed 
seed-free forage requirements, but would not include the current 
prohibition of failing to comply with Federal or State laws pertaining 
to resources.


In the early stages of planning this rule, BLM considered additional 
provisions such as Reserve Common Allotments for grazers to use when 
their allotments are unavailable due to fire, drought, or other 
factors, and authorizing grazers to lock gates on public lands 
temporarily. These provisions were dropped due to public comment on the 
advance notice of proposed rulemaking.


Anticipated Cost and Benefits:


BLM anticipates the following benefits: Increased livestock production 
as a result of increased forage productivity or increased ability to 
maintain grazing when it might otherwise be reduced; increased 
managerial flexibility, resulting in increased livestock output; 
improved environmental conditions; and potential changes in recreation 
values.


The major categories of costs include: BLM administrative costs 
(including enforcement and monitoring costs); compliance costs for 
permittees and lessees; environmental costs if the rule results in 
worsened environmental conditions.


The benefits and costs are thoroughly discussed in the Benefit-Cost/
Unfunded Mandates Act Analysis and Initial Regulatory Flexibility Act 
Analysis dated November 14, 2003, and available in the administrative 
record of the rule.


Risks:


As with any new rule, the public may at first misunderstand the changes 
in regulatory requirements. BLM will work with the public in 
implementing the rule and conduct outreach meetings to explain the rule 
as necessary.


There is also a risk that the monitoring requirements imposed by the 
rule may entail increased administrative costs and the need to 
reallocate administrative resources. We expect this risk to be 
minimized because of the thresholds in the regulations that must be 
crossed before monitoring is required.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           03/03/03                     68 FR 9964
NPRM                            12/08/03                    68 FR 68452
NPRM Comment Period End         03/02/04
Final Action                    11/00/05

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Ted Hudson
Regulatory Analyst
Department of the Interior
Bureau of Land Management
Room 420
Regulatory Affairs Group (WO-630)
1849 C Street NW.
Washington, DC 20240
Phone: 202 452-5042
Fax: 202 653-5287
Email: [email protected]
RIN: 1004-AD42
BILLING CODE 4310-10-S

[[Page 64192]]




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. 
The Department also has wide-ranging responsibilities for criminal 
investigations, law enforcement, and prosecutions and, in certain 
specific areas, makes use of the regulatory process to better carry out 
the Department's law enforcement missions.
 The Department of Justice's regulatory priorities focus in particular 
on a major regulatory initiative in the area of civil rights. 
Specifically, the Department is planning to revise its regulations 
implementing titles II and III of the Americans With Disabilities Act. 
However, in addition to this specific initiative, 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.
Civil Rights
 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 published by the U.S. Architectural and 
Transportation Barriers Compliance Board (Access Board) in final form 
on July 23, 2004. (The Access Board had issued the guidelines in 
proposed form 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 was engaged in a multiyear effort to 
revise and amend its accessibility guidelines. The goals of this 
project were: 1) To address issues such as unique State and local 
facilities (e.g., prisons, courthouses), recreation facilities, play 
areas, and building elements specifically designed for children's use 
that were not addressed in the initial guidelines; 2) to promote 
greater consistency between the Federal accessibility requirements and 
the model codes; and 3) to provide greater consistency between the ADA 
guidelines and the guidelines that implement the Architectural Barriers 
Act. The Access Board issued 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 revised ADA Standards for Accessible 
Design that are consistent with the revised ADA Accessibility 
Guidelines.
 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 three steps. The first step of the 
rulemaking process was an advance notice of proposed rulemaking, 
published in the Federal Register on September 30, 2004, at 69 FR 
58768, which the Department believes will simplify and clarify the 
preparation of the proposed rule to follow. In addition to giving 
notice of the proposed rule that will adopt revised ADA accessibility 
standards, the advance notice raised two sets of questions for public 
comment, and proposed a framework for the regulatory analysis that will 
accompany the proposed rule. One set of questions addresses 
interpretive matters related to adopting revised ADA accessibility 
standards, such as what should be the effective date of the revised 
standards and how best to apply the revised standards to existing 
facilities that have already complied with the current ADA standards. 
Another set of questions was directed to collecting data about the 
benefits and costs of applying the new standards to existing 
facilities. The second step of the rulemaking process will be a 
proposed rule proposing to adopt revised ADA accessibility standards 
consistent with the Access Board's revised and amended guidelines that 
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 
proposed rule will also offer proposed answers to the interpretive 
questions raised in the advance notice and present an initial 
regulatory assessment; it will be followed by a final rule, the third 
step of the process.
 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.
Other Department Initiatives
1. Immigration Matters
 On March 1, 2003, pursuant to the Homeland Security Act of 2002 (HSA), 
the responsibility for immigration enforcement and for providing 
immigration-related services and benefits such as naturalization and 
work

[[Page 64193]]

authorization was transferred from the Justice Department's Immigration 
and Naturalization Service (INS) to the Department of Homeland Security 
(DHS). However, immigration judges and the Board of Immigration Appeals 
in the Executive Office for Immigration Review (EOIR)) remain part of 
the Department of Justice; the immigration judges adjudicate 
approximately 300,000 cases each year to determine whether the aliens 
should be ordered removed or should be granted some form of relief from 
removal. Accordingly, the Attorney General has a continuing role in the 
conduct of removal hearings, the granting of relief from removal, and 
the detention or release of aliens pending completion of removal 
proceedings. The Attorney General also is responsible for civil 
litigation and criminal prosecutions relating to the immigration laws.
 In several pending rulemaking actions, the Department is working to 
revise and update the regulations relating to removal proceedings in 
order to improve the efficiency and effectiveness of the hearings in 
resolving issues relating to removal of aliens and the granting of 
relief from removal.
2. Criminal Law Enforcement
 In large part, the Department's criminal law enforcement components do 
not rely on the rulemaking process to carry out their assigned 
missions. The Federal Bureau of Investigation (FBI), for example, is 
responsible for protecting and defending the United States against 
terrorist and foreign intelligence threats, upholding and enforcing the 
criminal laws of the United States, and providing leadership and 
criminal justice services to Federal, State, municipal, and 
international agencies and partners. Only in very limited contexts does 
the FBI rely on rulemaking.\1\ However, other components do make use of 
the rulemaking process in certain significant respects.
---------------------------------------------------------------------------
\1\As one example, the FBI published a final rule in July 2004, 
amending regulations implementing the National Instant Criminal 
Background Check System (``NICS'') pursuant to the Brady Handgun 
Violence Prevention Act (``Brady Act''). This rule balanced the Brady 
Act's mandate that the Department protect legitimate privacy interests 
of law-abiding firearm transferees and the Department's obligation to 
enforce the Brady Act and the rest of the Gun Control Act to prevent 
prohibited persons from receiving firearms. Changes made by the final 
rule regarding the amount of time that the NICS retains information 
about approved firearm transfers in the system's chronological log of 
background check transactions (``Audit Log'') were required by section 
617 of H.R. 2673, the Fiscal Year 2004 Consolidated Appropriations 
bill, which was signed into law on January 23, 2004.
---------------------------------------------------------------------------
 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:
 Curb illegal traffic in, and criminal use of, firearms, and to 
            assist State, local, and other Federal law enforcement 
            agencies in reducing crime and violence;
 Facilitate investigations of violations of Federal explosives 
            laws and arson-for-profit schemes;
 Regulate the firearms and explosives industries, including 
            systems for licenses and permits;
 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
 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 2006, to seek 
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).
 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 for controlled 
substances, as well as the requirements of the Comprehensive 
Methamphetamine Control Act of 1996 and the Methamphetamine Anti-
Proliferation Act of 2000, which regulate certain chemicals to prevent 
them from being diverted for the production of methamphetamine.
 The Federal Bureau of Prisons issues regulations to enforce the 
Federal laws relating to its mission: To protect society by confining 
offenders in the controlled environments of prisons and community-based 
facilities that are safe, humane, cost-efficient, and appropriately 
secure, and that provide work and other self-improvement opportunities 
to assist offenders in becoming law-abiding citizens. During the next 
12 months, in addition to other regulatory objectives aimed at 
accomplishing its mission, the Bureau will continue its ongoing efforts 
to: Reduce the introduction of contraband through various means (such 
as clarifying drug and alcohol surveillance testing programs); improve 
disciplinary procedures; and improve drug abuse treatment services.
_______________________________________________________________________



DOJ--Civil Rights Division (CRT)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




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

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


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


CFR Citation:


28 CFR 36


Legal Deadline:


None


Abstract:


In 1991, the Department of Justice published regulations to implement 
title III of the Americans With Disabilities Act of 1990 (ADA). Those 
regulations include the ADA Standards for Accessible Design, which 
establish requirements for the design and construction of accessible 
facilities that are consistent with the ADA Accessibility Guidelines 
(ADAAG)

[[Page 64194]]

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 began the process of revising ADAAG 
a number of years ago. It published new ADAAG in final form on July 23, 
2004, after having published guidelines in proposed form in November 
1999 and in draft final form in April 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 revised ADA Standards consistent with the final 
revised ADAAG 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 first step in adopting revised Standards was an advance notice of 
proposed rulemaking that was published in the Federal Register on 
September 30, 2004, at 69 FR 58768, issued under both title II and 
title III. The Department believes that the advance notice will 
simplify and clarify the preparation of the proposed rule to follow. In 
addition to giving notice that the proposed rule will adopt revised ADA 
accessibility standards, the advance notice raised questions for public 
comment and proposed a framework for the regulatory analysis that will 
accompany the proposed rule.


The adoption of revised ADAAG will also serve to address changes to the 
ADA Standards previously proposed in RIN 1190-AA26, RIN 1190-AA38, RIN 
1190-AA47, and RIN 1190-AA50, all of which have now been withdrawn from 
the Unified Agenda. These changes will include technical specifications 
for facilities designed for use by children, accessibility standards 
for State and local government facilities, play areas, and recreation 
facilities, all of which had 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 second step 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 ADA Standards for Accessible Design consistent with the minimum 
guidelines of the revised ADAAG. 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 revised ADAAG, the Access Board made available 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                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           09/30/04                    69 FR 58768
ANPRM Comment Period End        01/28/05
ANPRM Comment Period 
    Extended                    01/19/05                     70 FR 2992
ANPRM Comment Period End        05/31/05
NPRM                            01/00/06
NPRM Comment Period End         07/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


None


Additional Information:


RIN 1190-AA44, which will effect changes to 28 CFR 36 (the Department's 
regulation implementing title III of the ADA), is related to another 
rulemaking of the Civil Rights Division, RIN 1190-AA46, which will 
effect changes to 28 CFR 35 (the Department's regulation implementing 
title II of the ADA).

[[Page 64195]]

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



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

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


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


CFR Citation:


28 CFR 35


Legal Deadline:


None


Abstract:


On July 26, 1991, the Department published its final rule implementing 
title II of the Americans With Disabilities Act (ADA). On November 16, 
1999, the U.S. Architectural and Transportation Barriers Compliance 
Board (Access Board) issued its first comprehensive review of the ADA 
Accessibility Guidelines, which form the basis of the Department's ADA 
Standards for Accessible Design. The Access Board published an 
Availability of Draft Final Guidelines on April 2, 2002, and published 
the ADA Accessibility Guidelines in final form on July 23, 2004. The 
ADA (section 204(c)) requires the Department's standards to be 
consistent with the Access Board's guidelines. In order to maintain 
consistency between ADAAG and the Standards, the Department is 
reviewing its title II regulations and expects to propose, in one or 
more stages, to adopt revised standards consistent with new ADAAG. 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 first part of the rulemaking process was an advance notice of 
proposed rulemaking, published in the Federal Register on September 30, 
2004, at 69 FR 58768, issued under both title II and title III. The 
Department believes the advance notice will simplify and clarify the 
preparation of the proposed rule to follow. In addition to giving 
notice of the proposed rule that will adopt revised ADA accessibility 
standards, the advance notice raised questions for public comment and 
proposed a framework for the regulatory analysis that will accompany 
the proposed rule.


The adoption of revised ADA Standards consistent with revised ADAAG 
will also serve to address changes to the ADA Standards previously 
proposed under RIN 1190-AA26, RIN 1190-AA38, RIN 1190-AA47, and RIN 
1190-AA50, all of which have now been withdrawn from the Unified 
Agenda. These changes will include technical specifications for 
facilities designed for use by children, accessibility standards for 
State and local government facilities, play areas, and recreation 
facilities, all of which had 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 second step 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 alone, this notice will also propose to eliminate 
the Uniform Federal Accessibility Standards (UFAS) as an alternative to 
the ADA Standards for Accessible Design.


Statement of Need:


Section 504 of the ADA requires the Access Board to issue supplemental 
minimum guidelines and requirements for accessible design of buildings 
and facilities subject to the ADA, including title II. Section 204(c) 
of the ADA requires the Attorney General to promulgate regulations 
implementing title II that are consistent with the Access Board's ADA 
guidelines. Because this rule will adopt standards that are consistent 
with the minimum guidelines issued by the Access Board, this rule is 
required by statute. Similarly, the Department's review of its title II 
regulations is being undertaken to comply with the requirements of the 
Regulatory Flexibility Act, as amended by the Small Business Regulatory 
Enforcement Fairness Act (SBREFA).


Summary of Legal Basis:


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


Alternatives:


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


Anticipated Cost and Benefits:


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


The Access Board has analyzed the effect of applying its proposed

[[Page 64196]]

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 revised ADAAG, the Access Board made available 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                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           09/30/04                    69 FR 58768
ANPRM Comment Period End        01/28/05
NPRM                            01/00/06
NPRM Comment Period End         07/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Governmental Jurisdictions


Government Levels Affected:


Local, State


Federalism:


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


Additional Information:


RIN 1190-AA46, 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 64197]]




DEPARTMENT OF LABOR (DOL)



2005 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 workplaces, as well as 
protection of their wages and pensions. 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. DOL also strives to provide 
employers with the knowledge and tools they need to carry out their 
legal obligations. Protecting America's workers is a top priority of 
the Secretary of Labor. 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. 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.
The Department is committed to aggressively enforcing the laws that 
protect employees, including the rights of workers returning to their 
jobs after military service. Workers also need information about 
protection of their health insurance and pension benefits. In addition, 
DOL has responsibilities beyond worker protection. The Department 
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.
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 by 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 14 high priority items for regulatory action. Five 
items 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 published an advance notice of proposed rulemaking (ANPRM) 
concerning asbestos exposure of miners, and conducted a series of 
public meetings in 2002 to allow early participation by interested 
parties in the rulemaking. A proposed rule was published in July 2005 
to lower the existing permissible exposure limit (PEL) for asbestos at 
metal and nonmetal mines, and at surface areas of underground coal 
mines. MSHA used the public comments received as a result of the ANPRM, 
and the experience of other agencies to help develop the proposed rule. 
MSHA will hold public hearings to solicit additional public input 
before a final rule is developed.
MSHA also continues its rulemaking on Diesel Particulate Matter 
Exposure of Underground Metal and Nonmetal Miners (RIN 1219-AB29). A 
final rule was published in June 2005 that converts the diesel 
particulate matter interim limit of 400 micrograms of total carbon to a 
more accurately measured equivalent 308 micrograms of elemental carbon. 
The standard includes a permissible exposure limit, establishes MSHA's 
longstanding hierarchy of controls required at metal and nonmetal 
mines, permits unlimited extensions at individual mines based on 
technological or economic feasibility, and eliminates the requirement 
for a control plan. A proposed rule was published in August 2005 that 
would revise the January 2006 effective date of the existing diesel 
particulate matter final limit to allow a 5-year phase-in of that final 
limit based on feasibility issues. The proposed rule also seeks input 
about medical evaluation before miners would be required to wear 
respirators and about transfer rights of miners who cannot wear 
respirators when their exposure to diesel particulate matter exceeds 
the allowable limits.
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.
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 informal public hearings were held on January 28-30, 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 
silica exposure may cause silicosis, a debilitating respiratory 
disease, and perhaps cancer as well. OSHA has obtained input from small 
businesses about regulatory approaches through a Small Business 
Regulatory Enforcement Fairness Act (SBREFA) panel, and the Panel 
report was submitted to the Assistant Secretary of OSHA on December 19, 
2003. OSHA plans to complete an external peer review of the health 
effects and risk assessment by April 2006.
OSHA's third health initiative addresses worker exposure to hexavalent 
chromium (RIN 1218-AB45). Approximately 380,000 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 has obtained input from small businesses 
about regulatory approaches through a Small Business Regulatory 
Enforcement Fairness Act (SBREFA) panel, which submitted a report to 
the Assistant Secretary for OSHA on April 20, 2004. The proposed rule 
was published on October 4, 2004. A final rule is expected in January 
2006.
Protection of pension and health benefits continues to be a priority of 
the Secretary of Labor. Consistent with the

[[Page 64198]]

Secretary's priorities for FY 2005, the Employee Benefits Security 
Administration (EBSA) will focus on compliance assistance for pension 
and group health plans through issuance of guidance. Specific 
initiatives for group health plans include guidance on the application 
of the Health Insurance Portability and Accountability Act (HIPAA) 
access, portability and renewability provisions (RIN 1210-AA54); and 
the HIPAA nondiscrimination provisions of the Employee Retirement 
Income Security Act (ERISA) (RIN 1210-AA77). With respect to pension 
plans, the Department will be developing guidance to encourage the 
automatic enrollment of participants in 401(k) plans and the use of 
default investment options that will enhance retirement savings (RIN 
1210-AB10). The Department also will be adopting standards that will 
facilitate the payment of benefits from 401(k) and other defined 
contribution plans that have been abandoned by their sponsors (RIN 
1210-AA97). In addition, the Department will be establishing standards 
to improve the disclosure of information concerning plan service 
provider fees and potential conflicts of interest to assist fiduciaries 
and participants in making informed decisions about their plans (RIN 
1210-AB07 and 1210-AB08).
ERISA's requirements affect an estimated 736,000 private sector 
employee pension benefit plans (covering approximately 103 million 
participants); an estimated 2.5 million group health benefit plans 
(covering 135 million participants and dependents); and 3.5 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. The regulations will be issued in two parts: regulations 
covering TAA program benefits (RIN 1205-AB32), and regulations covering 
petition filing, investigations and the new Alternative TAA Program for 
Older Workers (RIN 1205-AB40). The proposed rules would address the 
many new features of the TAA program: consolidation of the TAA and 
NAFTA-TAA programs; rapid response services for workers to facilitate 
more rapid reemployment; expanded eligibility; increased benefits, 
including health care insurance assistance; and Alternative TAA for 
Older Workers program. The new regulations will be written in plain 
English, making them easier to read and use.
The Employment Standards Administration (ESA) has one priority 
regulatory initiative. ESA's initiative pertains to regulations issued 
under the Family and Medical Leave Act (FMLA) that were also discussed 
in OMB's 2001, 2002 and 2004 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.
Finally, the Secretary's commitment to protecting the employment rights 
of service members as they return to the civilian workforce is 
reflected by the Veterans' Employment and Training Service's (VETS) 
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 service members 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.
_______________________________________________________________________



DOL--Employment Standards Administration (ESA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




74. FAMILY AND MEDICAL LEAVE ACT OF 1993; CONFORM TO THE SUPREME 
COURT'S RAGSDALE DECISION

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

[[Page 64199]]

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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Alfred B. Robinson
Deputy Administrator, Wage and Hour Division
Department of Labor
Employment Standards Administration
200 Constitution Avenue NW.
FP Building
S3502
Washington, DC 20210
Phone: 202 693-0051
Fax: 202 693-1302
RIN: 1215-AB35
_______________________________________________________________________



DOL--Employment and Training Administration (ETA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




75. REVISION TO THE DEPARTMENT OF LABOR BENEFIT REGULATIONS FOR TRADE 
ADJUSTMENT ASSISTANCE FOR WORKERS UNDER THE TRADE ACT OF 1974, AS 
AMENDED

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 665; 20 CFR 671; . . .


Legal Deadline:


None


Abstract:


The Trade Adjustment Assistance Reform 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 changes regarding trade adjustment assistance (TAA) program 
benefits.


It is the agency's intention to create a new 20 CFR part 618 to 
incorporate the amendments and write it in plain English, while 
amending the WIA regulations at 20 CFR parts 665 and 671 regarding 
Rapid Response and National Emergency Grants as they relate to the TAA 
program.


The proposed part 618 consists of nine subparts: subpart A - General; 
subpart B--Petitions and Determinations of Eligibility to Apply for 
Trade Adjustment Assistance (and Alternative TAA); subpart C---Delivery 
of Services throughout the One-Stop Delivery System; subpart D--Job 
Search Allowances; subpart E--Relocation Allowances; subpart F--
Training Services; subpart G--Trade Readjustment Allowances (TRA); 
subpart H--Administration by Applicable State Agencies; and subpart I--
Alternative Trade Adjustment Assistance for Older Workers. Because of 
the complexity of the subject matter and the States' needs for 
definitive instructions on providing TAA benefits, the rulemaking for 
part 618 is divided into two parts. This notice of proposed rulemaking 
covers the general provisions (subpart A) and TAA benefits portions 
(subpart C through subpart H) of the regulations. A separate notice of 
proposed rulemaking will cover the two remaining subparts (subpart B 
and subpart I).


Statement of Need:


The Trade Adjustment Assistance Reform 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 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 for Older Workers program that 
targets older worker groups who are certified as TAA eligible and 
provides the option of a wage supplement instead of training, job 
search, and income support.


The Department is mandated to implement the amendments within 90 days 
from enactment (November 4, 2002), and it issued operating instructions 
in a guidance letter on October 10, 2002, and later published in the 
Federal Register (67 FR 69029-41). 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.

[[Page 64200]]

Summary of Legal Basis:


These regulations are authorized by 19 U.S.C. 2320 due to the 
amendments to the Trade Act of 1974 by the Trade Adjustment Assistance 
Reform Act of 2002.


Alternatives:


The public will be afforded an opportunity to provide comments on the 
TAA program changes when the Department publishes the proposed 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Agency Contact:
Terry Clark
Acting Director, Trade Adjustment Assistance
Department of Labor
Employment and Training Administration
200 Constitution Avenue NW.
FP Building, Room C5311
Washington, DC 20210
Phone: 202 693-3707
Email: [email protected]
RIN: 1205-AB32
_______________________________________________________________________



DOL--ETA



76. REVISION TO THE DEPARTMENT OF LABOR REGULATIONS FOR PETITIONS AND 
DETERMINATIONS OF ELIGIBILITY TO APPLY FOR TRADE ADJUSTMENT ASSISTANCE 
FOR WORKERS AND ISSUANCE OF REGULATIONS FOR THE ALTERNATIVE TAA

Priority:


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


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 665; 20 CFR 671; . . .


Legal Deadline:


None


Abstract:


The Trade Adjustment Assistance Reform 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 changes regarding trade adjustment assistance (TAA) program 
benefits.


It is the agency's intention to create a new 20 CFR part 618 to 
incorporate the amendments and write it in plain English, while 
amending the WIA regulations at 20 CFR parts 665 and 671 regarding 
Rapid Response and National Emergency Grants as they relate to the TAA 
program.


The proposed part 618 consists of nine subparts: subpart A--General; 
subpart B--Petitions and Determinations of Eligibility to Apply for 
Trade Adjustment Assistance (and Alternative TAA); subpart C--Delivery 
of Services throughout the One-Stop Delivery System; subpart D--Job 
Search Allowances; subpart E--Relocation Allowances; subpart F--
Training Services; subpart G--Trade Readjustment Allowances (TRA); 
subpart H--Administration by Applicable State Agencies; and subpart I--
Alternative Trade Adjustment Assistance (ATAA) for Older Workers. 
Because of the complexity of the subject matter and the States' needs 
for definitive instructions on providing TAA benefits, the rulemaking 
for part 618 is divided into two parts. This notice of proposed 
rulemaking covers the petitions and determinations (subpart B) and ATAA 
(subpart I) of the regulations. A separate notice of proposed 
rulemaking will cover the remaining subparts (subpart A and subparts C 
through H).


Statement of Need:


The Trade Adjustment Assistance Reform 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 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 for Older Workers program that 
targets older worker groups who are certified as TAA eligible and 
provides the option of a wage supplement instead of training, job 
search, and income support.


The Department is mandated to implement the amendments within 90 days 
from enactment (November 4, 2002), and it issued operating instructions 
in a guidance letter on October 10, 2002, and later published in the 
Federal Register (67 FR 69029-41). 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 19 U.S.C. 2320 due to the 
amendments to the Trade Act of 1974 by the Trade Adjustment Assistance 
Reform Act of 2002.


Alternatives:


The public will be afforded an opportunity to provide comments on the 
TAA program changes when the Department publishes the proposed rule in 
the Federal Register.

[[Page 64201]]

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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/00/06

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, State


Agency Contact:
Terry Clark
Acting Director, Trade Adjustment Assistance
Department of Labor
Employment and Training Administration
200 Constitution Avenue NW.
FP Building, Room C5311
Washington, DC 20210
Phone: 202 693-3707
Email: [email protected]
RIN: 1205-AB40
_______________________________________________________________________



DOL--Employee Benefits Security Administration (EBSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




77. AMENDMENT OF REGULATION RELATING TO DEFINITION OF PLAN ASSETS--
PARTICIPANT CONTRIBUTIONS

Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 1135


CFR Citation:


29 CFR 2510.3-102


Legal Deadline:


None


Abstract:


This rulemaking will amend the regulation that defines when participant 
monies paid to or withheld by an employer for contribution to an 
employee benefit plan constitute ``plan assets'' for purposes of title 
I of ERISA and the related prohibited transaction provisions of the 
Internal Revenue Code. The regulation contains an amendment to the 
current regulation that will establish a safe harbor period of a 
specified number of business days during which certain monies that a 
participant pays to, or has withheld by, an employer for contribution 
to a plan would not constitute ``plan assets.''


Statement of Need:


This amendment of the participant contribution regulation would, upon 
adoption, establish a ``safe harbor'' period of a specified number of 
days during which certain monies that a participant pays to, or has 
withheld from wages, by an employer for contribution to an employee 
benefit plan, would not constitute plan assets for purposes of title I 
of ERISA and the related prohibited transaction provisions of the 
Internal Revenue Code. The amendment is needed to provide greater 
certainty to employers, participants and beneficiaries, service 
providers and others concerning when participant contributions to a 
plan constitute plan assets.


Summary of Legal Basis:


Section 505 of ERISA provides that the Secretary may prescribe such 
regulations as she finds necessary and appropriate to carry out the 
provisions of title I of the Act. Regulation 29 CFR 2510.3-102 provides 
that the assets of an employee benefit plan covered by title I of ERISA 
include amounts (other than union dues) that a participant or 
beneficiary pays to an employer, or has withheld from wages by an 
employer, for contribution to the plan as of the earliest date on which 
such contributions can reasonably be segregated from the employer's 
general assets; the regulation also specifies the maximum time period 
for deposit of such contributions by the employer.


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 the safe harbor that would be afforded by the 
proposed amendment with regard to monies contributed to employee 
benefit plans would deprive employers, other plan fiduciaries, and 
service providers of the certainty they need to optimize compliance 
with the law. Also, any risk of loss or lost earnings resulting from 
permitting employers who would otherwise transmit contributions to the 
plan sooner than the time specified in the safe harbor should be 
minimal, while the benefits attendant to encouraging employers to 
review and modify their systems or practices to take advantage of the 
safe harbor may be significant.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Louis J. Campagna
Chief, Division of Fiduciary Interpretations, Office of Regulations and 
Interpretations
Department of Labor
Employee Benefits Security Administration
200 Constitution Avenue NW.
Room N5669
FP Building
Washington, DC 20210
Phone: 202 693-8512
Fax: 202 219-7291
RIN: 1210-AB02
_______________________________________________________________________



DOL--EBSA



78.  AMENDMENT OF SECTION 404(C) REGULATION DEFAULT INVESTMENTS

Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


29 USC 1104(c); 29 USC 1135


CFR Citation:


29 CFR 2550

[[Page 64202]]

Legal Deadline:


None


Abstract:


This rulemaking would amend the regulation to address the application 
of section 404(c)of ERISA under circumstances where a participant is 
automatically enrolled in a 401(k) or similar individual account plan 
and that participant fails to direct the investment of his or her 
contributions. This rulemaking also would address the extent to which 
fiduciary liability for investment decisions might be limited through 
the use of a default investment vehicle.


Statement of Need:


Section 404(c)(1) of ERISA provides that, where a participant or 
beneficiary of an employee pension benefit plan exercises control over 
assets in an individual account maintained for him or her under the 
plan, the participant or beneficiary is not considered a fiduciary by 
reason of his or her exercise of control and other plan fiduciaries are 
relieved of liability under part 4 of title I of ERISA for the results 
of such exercise of control. The Department has previously issued 
regulations under section 404(c)(1) describing the circumstances in 
which 404(c)(1) applies to a transaction involving a participant's or 
beneficiary's exercise of control over his or her account. This 
rulemaking would amend those regulations to respond to a need on the 
part of plan sponsors and fiduciaries for guidance on the selection of 
default investments for plan participants who fail to make an 
investment election. Such guidance would also improve retirement 
savings for millions of American workers.


Summary of Legal Basis:


Promulgation of this regulation is authorized by sections 505 and 
404(c) of ERISA


Alternatives:


Regulatory alternatives will be developed once determinations have been 
made with regard to the scope and nature of the regulatory guidance 
that will be necessary to provide for default investment options when a 
participant in a 401(k) or similar individual account plan fails to 
direct the investment of his or her account.


Anticipated Cost and Benefits:


Costs and benefits of regulatory alternatives will be estimated and 
taken into account in the development of the proposed regulation. 
Intended benefits include increases in 401(k) plan participation rates, 
more beneficial asset allocations of many participants' accounts, and 
attendant improvements in retirement security.


Risks:


Failure to provide guidance on default investment options for 
individual account plans may result in diminished retirement savings 
for the many participants who fail to make an investment election with 
regard to their accounts.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Federalism:


 Undetermined


Agency Contact:
Erin Sweeney
Senior Pension Law Specialist, ORI
Department of Labor
Employee Benefits Security Administration
200 Constitution Avenue, NW.
Rm N5669
FP Building
Washington, DC 20210
Phone: 202 693-8500
RIN: 1210-AB10
_______________________________________________________________________



DOL--EBSA

                              -----------

                            FINAL RULE STAGE

                              -----------




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

Priority:


Economically Significant. Major under 5 USC 801.


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:


None


Abstract:


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


Statement of Need:


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


Summary of Legal Basis:


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


Risks:


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


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule 
    Effective                   06/07/97
Interim Final Rule 
    Comment Period End          07/07/97
Request for Information         10/25/99                    64 FR 57520
Comment Period End              01/25/00
NPRM                            12/30/04                    69 FR 78800
Request for Information         12/30/04                    69 FR 78825
Final Rule                      12/30/04                    69 FR 78720
Final Action Effective          02/28/05
Request for Information/ 
    Comment Period End          03/30/05

[[Page 64203]]

NPRM Comment Period End         03/30/05
Final Action                    09/00/06

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Amy Turner
Senior 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



80. 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 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 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                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule 
    Comment Period End          07/07/97
NPRM                            01/08/01                     66 FR 1421
NPRM Comment Period End         04/09/01
Second Interim Final Rule       01/08/01                     66 FR 1378
Interim Final Rule 
    Comment Period End          04/09/01
Final Rule                      02/00/06

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
Senior 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--EBSA



81. RULEMAKING RELATING TO TERMINATION OF ABANDONED INDIVIDUAL ACCOUNT 
PLANS

Priority:


Other Significant


Legal Authority:


29 USC 1135; 29 USC 1002(16)(A)


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 abandoned 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 
ongoing administrative costs and other factors, the continued 
maintenance of such plans is often not in the interest of the

[[Page 64204]]

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 necessary to distribute 
benefits and shut down plan operations.


Summary of Legal Basis:


Section 505 of ERISA provides that the Secretary may prescribe such 
regulations as the Secretary finds necessary and appropriate to carry 
out 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.


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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/10/05                    70 FR 12046
NPRM Comment Period End         05/09/05
Final Action                    01/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses, Organizations


Government Levels Affected:


None


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



DOL--Mine Safety and Health Administration (MSHA)

                              -----------

                            FINAL RULE STAGE

                              -----------




82. 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 proposed a rule 
to lower the PEL in order to reduce the risk of miners developing 
asbestos-induced occupational disease. A 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 
sufficiently 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 newer information and studies on the 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 increased sampling efforts in an attempt to determine 
current miners' exposure levels to asbestos, including taking samples 
at all existing vermiculite, taconite, talc, and other mines to 
determine whether asbestos is present and at what levels. In early 
2000, MSHA began an intensive sampling effort at operations with 
potential asbestos exposure. 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 developed a preliminary regulatory economic analysis to accompany 
the proposed rules.

[[Page 64205]]

Risks:


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, lung cancer, mesothelioma, and other forms of cancers.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           03/29/02                    67 FR 15134
Notice of Change to 
    Public Meetings             04/18/02                    67 FR 19140
ANPRM Comment Period End        06/27/02
NPRM                            07/29/05                    70 FR 42950
NPRM Comment Period End         09/20/05                    70 FR 43950
Public Hearing                  10/18/05                    70 FR 43950
Final Action                    07/00/06

Regulatory Flexibility Analysis Required:


No


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:
Rebecca J. Smith
Acting Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
1100 Wilson Boulevard
Rm 2350
Arlington, VA 22209
Phone: 202 693-9440
Fax: 202 693-9441
Email: [email protected]
RIN: 1219-AB24
_______________________________________________________________________



DOL--MSHA



83. DIESEL PARTICULATE MATTER EXPOSURE OF UNDERGROUND METAL AND 
NONMETAL MINERS

Priority:


Other Significant


Legal Authority:


30 USC 811; 30 USC 813


CFR Citation:


30 CFR 57


Legal Deadline:


None


Abstract:


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 established 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 
was published on February 27, 2002 (67 FR 9180). MSHA issued an advance 
notice of proposed rulemaking (ANPRM) on September 25, 2002 (67 FR 
60199) to obtain additional information and published a notice of 
proposed rulemaking (NPRM) in August 2003 (68 FR 48668). MSHA issued a 
final rule on June 6, 2005 (70 FR 32868) that revises MSHA's existing 
standards addressing diesel particulate matter (DPM) exposure in 
underground metal and nonmetal (M/NM) mines. The rule, among other 
things, changes the interim concentration limit measured by total 
carbon (TC) to a comparable permissible exposure limit (PEL) measured 
by elemental carbon (EC). MSHA is developing a rule to phase in 
implementation of the final limit.


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 
(66 FR 35518).


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 (66 FR 35521). The final 
rule on these issues was published February 27, 2002, and became 
effective March 29, 2002.


As a result of the second partial settlement agreement, MSHA proposed 
specific changes to the 2001 DPM final rule. On September 25, 2002, 
MSHA published an ANPRM. In response to commenters, MSHA proposed and 
finalized changes only to the interim DPM standard of 400 micrograms 
per cubic meter of air. MSHA also committed to proposing a rule to 
revise the final DPM limit of 160 micrograms per cubic meter of air.


Summary of Legal Basis:


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


Alternatives:


This rulemaking would amend and improve health protection from that 
afforded by the existing standard.


Anticipated Cost and Benefits:


MSHA's preliminary economic analysis indicates that making the changes 
under consideration would result in a net cost savings to the mining 
industry.


Risks:


A number of epidemiological studies have found that exposure to diesel 
exhaust presents potential health risks to 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                            Date                        FR Cite

_______________________________________________________________________
Final Action                    02/27/02                     67 FR 9180
ANPRM                           09/25/02                    67 FR 60199
ANPRM Comment Period End        11/25/02
NPRM                            08/14/03                    68 FR 48668
NPRM Comment Period End         10/14/03
Limited Reopening of the 
    Comment Period              02/20/04                     69 FR 7881
Limited Reopening of the 
    Comment Period End          04/05/04                     69 FR 7881

[[Page 64206]]

Final Action                    06/06/05                    70 FR 32868
Final Action Effective          07/06/05
Second NPRM                     09/07/05                    70 FR 53280
Notice of Public Hearing        09/07/05                    70 FR 53280
Close of Comment Period         09/07/05                    70 FR 53280
Request for Data                09/07/05                    70 FR 53280
Comment Period Extended         09/19/05                    70 FR 55018
Change of Public Hearings 
    Dates                       09/19/05                    70 FR 55018
Final Action                    05/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Rebecca J. Smith
Acting Director, Office of Standards
Department of Labor
Mine Safety and Health Administration
1100 Wilson Boulevard
Rm 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

                              -----------




84. 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.


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 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. 
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 is under way.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Completed SBREFA Report         12/19/03

[[Page 64207]]

Complete Peer Review of 
    Health Effects and 
    Risk Assessment             04/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Undetermined


Agency Contact:
Dorothy Dougherty
Acting Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
FP Building
Room 3718
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
Email: [email protected]
RIN: 1218-AB70
_______________________________________________________________________



DOL--OSHA

                              -----------

                            FINAL RULE STAGE

                              -----------




85. 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 an 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, and 
an informal public hearing was held January 28-30, 2004.


Statement of Need:


About five million employees wear respirators as part of their regular 
job duties. Due to inconsistencies between the APFs found in 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.


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 under that standard.


Alternatives:


OSHA has considered allowing the current situation to continue. 
Accordingly, OSHA generally enforces NIOSH APFs, but many employers 
follow the more recent ANSI Z88.2-1992 APFs. However, allowing the 
situation to continue results in inconsistent 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                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           05/14/82                    47 FR 20803
ANPRM Comment Period End        09/13/82
NPRM                            11/15/94                    59 FR 58884
Final Rule                      01/08/98                     63 FR 1152
Final Rule Effective            04/08/98
NPRM                            06/06/03                    68 FR 34036
NPRM Comment Period End         09/04/03
NPRM Comment Period 
    Extended                    10/02/03                    68 FR 53311
Public Hearing on 01/28/
    2004                        11/12/03                    68 FR 64036
Final Rule: Revocation of 
    Respiratory 
    Protection M. TB            12/31/03                    68 FR 75767
Public Hearing                  01/28/04
Post-Hearing Comment and 
    Brief Period Extended       03/30/04                    69 FR 16510
Post-Hearing Comment 
    Period End                  04/29/04
Post-Hearing Briefs End         05/29/04
Final Action                    03/00/06

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal, Local, State, Tribal

[[Page 64208]]

Agency Contact:
Dorothy Dougherty
Acting Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
FP Building
Room 3718
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
Email: [email protected]
RIN: 1218-AA05
_______________________________________________________________________



DOL--OSHA



86. OCCUPATIONAL EXPOSURE TO HEXAVALENT CHROMIUM (PREVENTING 
OCCUPATIONAL ILLNESS: CHROMIUM)

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


29 USC 655(b); 29 USC 657


CFR Citation:


29 CFR 1910


Legal Deadline:


NPRM, Judicial, October 4, 2004.


Final, Judicial, January 18, 2006.


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/m3) 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 PEL of 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 OCAW 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 and Paper, Allied-International, Chemical 
and Energy Workers International Union (PACE) 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 Appeals ruled in favor of HRG and ordered the Agency to 
proceed expeditiously with a CrVI standard. OSHA published a notice of 
proposed rulemaking on CrVI on October 4, 2004. Public hearings were 
held February 1-15, 2005.


Statement of Need:


Approximately 380,000 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, 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 Industrial 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.


Anticipated Cost and Benefits:


In the NPRM, OSHA preliminary estimates the cost of the proposed 
standards at $223 million per year. OSHA preliminarily estimates the 
proposed standard will prevent an average of 44 to 167 cases on cancer 
per year, and will have monetary benefits of $25 million to $701 
million per year.


Risks:


A detailed risk analysis is included in the NPRM.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Request for Information         08/22/02                    67 FR 54389
Comment Period End              11/20/02
Initiate SBREFA Process         12/23/03
SBREFA Report                   04/20/04
NPRM                            10/04/04                    69 FR 59305
NPRM Comment Period End         01/03/05
Public Hearings 2/1-15/
    2005                        02/01/05
Final Rule                      01/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Local, State

[[Page 64209]]

Agency Contact:
Dorothy Dougherty
Acting Director, Directorate of Standards and Guidance
Department of Labor
Occupational Safety and Health Administration
200 Constitution Avenue NW.
FP Building
Room 3718
Washington, DC 20210
Phone: 202 693-1950
Fax: 202 693-1678
Email: [email protected]
RIN: 1218-AB45
_______________________________________________________________________



DOL--Office of the Assistant Secretary for Veterans' Employment and 
Training (ASVET)

                              -----------

                            FINAL RULE STAGE

                              -----------




87. UNIFORMED SERVICES EMPLOYMENT AND REEMPLOYMENT RIGHTS ACT 
REGULATIONS

Priority:


Other Significant


Legal Authority:


38 USC 4331(a)


CFR Citation:


20 CFR 1002


Legal Deadline:


None


Abstract:


The Secretary's commitment to protecting the employment rights of 
service members 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) with 
regard to States, local governments and private employers. 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, although the law dates back to 1994.


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, eligible 
service members who leave their civilian jobs for military service are 
entitled to return to reemployment with their previous employers with 
the seniority, status and rate of pay they would have attained had they 
not been away on duty. USERRA also assures that they will not suffer 
discrimination in employment because of their military service or 
obligations.


Following the attacks of September 11, 2001, the President authorized a 
major mobilization of National Guard and Reserve forces that has 
continued into 2005. In the past three years, the Department has 
experienced a tremendous increase in the number of inquiries about 
USERRA from employers and members of the Guard and Reserve. The high 
volume of requests for technical assistance indicates that there is a 
significant need for consistent and authoritative USERRA guidance. 
USERRA regulations will provide the Department's interpretations of the 
law and 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 a 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/20/04                    69 FR 56266
NPRM Comment Period End         11/19/04
Final Action                    10/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, Local, State


Agency Contact:
Robert Wilson
Chief, Investigations and Compliance Division
Department of Labor
Office of the Assistant Secretary for Veterans' Employment and Training
200 Constitution Avenue NW.
Room S-1316
Washington, DC 20210
Phone: 202 693-4719
Fax: 202 693-4755
Email: [email protected]
RIN: 1293-AA09
BILLING CODE 4510-23-S

[[Page 64210]]




DEPARTMENT OF TRANSPORTATION (DOT)



Statement of Regulatory Priorities
The Department of Transportation (DOT) consists of ten operating 
administrations, 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.
An important initiative of Secretary Mineta's has been to increase the 
timeliness of DOT rulemaking actions and address the large number of 
old rulemakings. To implement this, the Secretary has required (1) 
regular meetings of senior DOT officials to ensure effective scheduling 
of rulemakings and timely decisions, (2) better tracking and 
coordination of rulemakings, (3) regular reporting, (4) early briefings 
of interested officials, (5) better training of staff, and (6) 
necessary resource allocations. The Department has achieved significant 
success as a result of this initiative with the number of old 
rulemakings as well as the average time to complete rulemakings 
decreasing. This is also allowing the Department to use its resources 
more effectively and efficiently.
The Department's regulatory policies and procedures provide a 
comprehensive internal management and review process for new and 
existing regulations and ensure that the Secretary and other 
appropriate appointed officials review and concur in all significant 
DOT rules. DOT continually seeks to improve its regulatory process. The 
Department's development of regulatory process and related training 
courses for its employees; creation of an electronic, Internet-
accessible docket that can also be used to submit comments 
electronically; a ``list serve'' that allows the public to sign up for 
e-mail notification when the Department issues a rulemaking document; 
creation of an electronic rulemaking tracking 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 is 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.
In addition, on January 26, 2005, the Department issued a special 
regulatory review notice providing the public with an additional 
opportunity to give comments on the Department's existing rules and 
regulatory agenda. The focus of the regulatory review was on (1) which 
existing DOT rules needed to be changed to make them more effective or 
(2) getting suggestions for different priorities in our agenda. In 
response, the Department received over sixty comments.
Over the next year, the Department will focus its efforts on the 
regulatory requirements enacted by the Safe, Accountable, Flexible, and 
Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU). 
The Department will also continue its efforts to use advances in 
technology to improve its rulemaking management process. 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 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 role in the Department's 
efforts to improve our economic analyses; risk assessments; regulatory 
flexibility analyses; other

[[Page 64211]]

related analyses; and data quality, including peer reviews.
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 2006, OST will continue its efforts to complete work 
on an NPRM that will propose accessibility requirements for vessels 
which involves complex issues unlike those affecting land 
transportation. This NPRM will propose feasible requirements to make 
passenger vessels accessible to, and usable by, individuals with 
disabilities.
Federal Aviation Administration (FAA)
The Federal Aviation Administration is charged with safely and 
efficiently operating and maintaining the most complex aviation system 
in the world. We are guided by our Flight Plan goals -- Increased 
Safety, Greater Capacity, International Leadership, and Organizational 
Excellence. We issue regulations to provide a safe and efficient global 
aviation system for civil aircraft. Activities that may lead to 
rulemaking include:
 Promotion and expansion of safety information sharing efforts 
            such as FAA-industry partnerships and data-driven safety 
            programs that prioritize and address risks before they lead 
            to accidents. Specifically, we will continue implementing 
            Commercial Aviation Safety Team projects related to 
            controlled flight into terrain, loss of control of an 
            aircraft, uncontained engine failures, runway incursions, 
            weather, pilot decision making, and cabin safety. Some of 
            these projects may result in rulemaking and guidance 
            materials.
 Continuing to work cooperatively to harmonize the U.S. 
            aviation regulations with those of other countries. 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. Standardization should help the U.S. aerospace 
            industry remain internationally competitive. The FAA 
            continues to publish regulations based on recommendations 
            of Aviation Rulemaking Committees that are the result of 
            cooperative rulemaking between the U.S. and other 
            countries.
Top regulatory priorities for 2005-2006 include a final rule concerning 
flight simulation device requirements, rulemaking to address Fuel Tank 
Flammability Reduction in Transport Category Airplanes, and several 
rulemaking projects known collectively as the FAA's Aging Airplane 
Program. The FAA developed the Aging Airplane Program to address 
structural and non-structural system safety issues that may arise as 
airplanes age and in response to:
(1). Airplanes being operated beyond their original design service 
            goals;
(2). The 1988 Aloha Boeing 737 accident; and
(3). The Aging Airplane Safety Act of 1991.
The remaining rulemakings included in the Aging Airplane Program are:
(1). Enhanced Airworthiness Program for Aging Systems/Fuel Tank Safety;
(2). Development of Type Certificate and Supplemental Type Certificate 
            Holder Data for Aging Aircraft Safety Program; and
(3). Widespread Fatigue Damage Program.
Federal Highway Administration (FHWA)
The Federal Highway Administration (FHWA) carries out the Federal 
highway programs in partnership with State and local agencies to meet 
the Nation's transportation needs. The FHWA's mission is to continually 
improve the quality and performance of our Nation's highway system and 
its intermodal connectors.
Consistent with this mission, the FHWA will continue:
 with ongoing regulatory initiatives in support of its surface 
            transportation programs;
 to implement legislation in the least burdensome and 
            restrictive way possible; and
 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.
Recently, the Safe, Accountable, Flexible, and Efficient Transportation 
Equity Act: A Legacy for Users or SAFETEA-LU was enacted. The FHWA is 
analyzing SAFETEA-LU to identify congressionally directed rulemakings. 
Additionally, the FHWA will review all FHWA regulations to ensure that 
they are consistent with the recently enacted legislation.
Federal Motor Carrier Safety Administration (FMCSA)
The mission of Federal Motor Carrier Safety Administration (FMCSA) is 
to reduce crashes, injuries and fatalities involving commercial trucks 
and buses. A strong regulatory program is a cornerstone of FMCSA's 
compliance and enforcement efforts to advance this safety mission. 
Developing new, amended and more effective safety regulations through 
the rulemaking process is key to achieving increased safety on our 
Nation's highways by establishing standards for drivers, carriers, 
States, and others that create improved safety conditions and operating 
practices. In its first five years of operations, FMCSA has responded 
to Congressional concerns, as expressed in our enabling legislation, 
The Motor Carrier Safety Improvement Act of 1999 (MCSIA), over delays 
in timely rulemaking. There is steady progress being made, with the 
backlog of rules being systematically addressed.
First, FMCSA developed a directive establishing a formalized rulemaking 
process with ongoing oversight and involvement by senior agency leaders 
to lend structure and accountability to the rulemaking process. We 
continue to monitor the process and update the directive when 
additional issues are identified; a comprehensive update of this 
directive is scheduled to go into effect in Fall 2005.
Second, FMCSA has made significant progress in reducing the backlog and 
addressing longstanding and stale initiatives, including those not 
mandated by Congress. FMCSA has completed all of its MCSIA rulemakings, 
except one, and that rulemaking, ``Medical Certification as part of the 
Commercial Drivers License'' (RIN 2126-AA10) is among our highest 
priorities and is included in the Regulatory Plan. It will serve as the 
first step in a comprehensive update of the way that the Agency 
addresses the medical condition of the drivers who operate commercial 
motor vehicles (CMVs).

[[Page 64212]]

As a result of reauthorization legislation, the FMCSA's regulatory 
docket is increasing substantially. The Agency is committed to using 
its resources and personnel in the most effective manner to accomplish 
these additional tasks and still complete its ongoing projects. 
Therefore, the Agency's other entry to the Regulatory Plan continues to 
be the ``Unified Registration System'' rulemaking (RIN 2126-AA22), now 
at the final rule stage, that will create a new, unified and updated 
registration system that benefits both the users with simplified 
processes and FMCSA with better data.
In the past year, FMCSA issued a notice of proposed rulemaking and a 
final rule on hours of service (HOS) in response to both the concerns 
of the U.S. Court of Appeals for the D.C. Circuit (Public Citizen et 
al. v. FMCSA) and the action of Congress in extending the last previous 
surface transportation act to maintain the effectiveness of the April 
2003 HOS final rule until September 30, 2005. Also, the Agency held 
several public listening sessions under the Comprehensive Safety 
Analysis 2010 Initiative and is analyzing the results and other input 
to design and improve the way FMCSA conducts compliance and enforcement 
operations over the coming years. FMCSA anticipates that the first 
results of this initiative and its associated rulemakings will 
contribute to the Agency's goal of decreasing CMV fatalities to no more 
than 1.65 per 100 million miles by the end of 2008.
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 non-regulatory 
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 continues to pursue the high priority vehicle safety area of 
vehicle compatibility. In FY 2006, a final rule is planned for a 
significant upgrade to the side impact standard, FMVSS No. 214. A 
notice of proposed rulemaking was published for the side impact upgrade 
in 2004. Publication of this final rule also will meet a regulatory 
requirement in the SAFETEA-LU. To further improve occupant crash 
protection, a final rule will be published to add requirements to FMVSS 
No. 208 for belted occupants of small stature. Significant actions in 
crash avoidance will include a rulemaking notice aimed at shortening 
heavy truck stopping distances. Light truck fuel economy standards for 
Model Years 2008 and possibly beyond will be published, in accordance 
with statutory requirements. In addition, the Agency will publish an 
update to the NHTSA Vehicle Safety Rulemaking Priorities and Supporting 
Research plan, originally published in FY 2003 and updated in FY 2005. 
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. In 2003, it 
released a report analyzing safety belt use problems and describing 
actions to address them. A separate report analyzed and described 
actions to address the problem of impaired driving. To address this 
problem, the Agency is focusing especially on three strategies -- 
conducting highly visible, well-publicized enforcement; supporting 
prosecutors who handle impaired driving cases and expanding the use of 
DWI/Drug Courts, which hold offenders accountable for receiving and 
completing treatment for alcohol abuse and dependency; and the adoption 
of alcohol screening and brief intervention by medical and health care 
professionals. Other behavioral efforts encourage child safety-seat 
use; combat excessive speed and aggressive driving; improve motorcycle, 
bicycle, and pedestrian safety; and provide consumer information to the 
public.
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 and require cooperative 
action by all affected parties. In order to foster an environment for 
collaborative rulemaking, FRA established the Railroad Safety Advisory 
Committee (RSAC). The purpose of the 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 the RSAC's recommendations. The RSAC meets regularly, and 
its working groups are actively addressing the following tasks: (1) the 
development of safety standards for locomotive crashworthiness; (2) the 
development of safety standards for locomotive working conditions, 
including occupational noise exposure; and (3) the development and 
revision of certain regulations addressing the safety of rail passenger 
service. Recently, FRA completed a rulemaking entitled ``Performance 
Standards for Processor-Based Signal and Train Control Systems,'' which 
was based on an RSAC recommendation (for a proposed rule on the 
subject); published a final rule on the crashworthiness of locomotive 
event recorders based on the RSAC's consensus recommendations; and 
completed a final rule entitled ``Use of Locomotive Horns at Highway-
Rail Grade Crossings.''
During calendar 2005-2006, as a part of the National Rail Safety Action 
Plan, FRA plans to develop and issue a proposed rule to enhance 
compliance with railroad operating rules, addressing the causes of many 
human-factor train accidents.
Federal Transit Administration (FTA)
The Federal Transit Administration (FTA) provides financial assistance 
to State and local governments for mass transportation purposes. The 
regulatory activity of FTA focuses on establishing the terms and 
conditions of Federal financial assistance available under the Federal 
transit laws.

[[Page 64213]]

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. As a result of the reauthorization 
legislation, the FTA's regulatory activity will include a number of 
substantive rulemakings. A few of those rulemakings may be explicitly 
mandated by the statute. Others will become necessary simply to make 
amendments to current regulations to make them consistent with the 
statute. FTA's regulatory priorities for the coming year will be 
reflective of the directives and the programmatic priorities 
established by the statute.
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.
Pipeline and Hazardous Materials Safety Administration (PHMSA)
The Pipeline and Hazardous Materials Administration (PHMSA) has 
responsibility for rulemaking under two programs. Through the Associate 
Administrator for Hazardous Materials Safety, PHMSA administers 
regulatory programs under Federal hazardous materials transportation 
law and the Federal Water Pollution Control Act, as amended by the Oil 
Pollution Act of 1990. Through the Associate Administrator for Pipeline 
Safety, PHMSA 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.
Research and Innovative Technology Administration (RITA)
The Research and Innovative Technology Administration (RITA) seeks to 
identify and facilitate solutions to the challenges and opportunities 
facing America's transportation system through:
 coordination, facilitation, and review of the Department's 
            research and development programs and activities;
 advancement, and research and development, of innovative 
            technologies, including intelligent transportation systems;
 comprehensive transportation statistics research, analysis, 
            and reporting;
 education and training in transportation and transportation-
            related fields; and
 managing the activities of the Volpe National Transportation 
            Center.
Through its Bureau of Transportation Statistics, RITA collects, 
compiles, analyzes, and makes accessible information on the Nation's 
transportation system. RITA 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 airline operations and is used in supporting policy 
initiatives, negotiating international bilateral aviation agreements, 
awarding international route authorities, and meeting international 
treaty obligations.
RITA's regulatory priorities are to assist OST and all DOT modal 
administrations in updating existing regulations by applying research 
and technology results, and to provide information to transportation 
system decision makers.
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--Federal Aviation Administration (FAA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




88. [rplus]AGING AIRCRAFT PROGRAM (WIDESPREAD FATIGUE DAMAGE)

Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 40119; 49 USC 41706; . . .


CFR Citation:


14 CFR 121; 14 CFR 129


Legal Deadline:


None


Abstract:


This rulemaking would require incorporation of a program to preclude 
widespread fatigue damage into the FAA-approved maintenance program of 
each operator of large transport category airplanes. This action is the 
result of concern for the continued operational safety of airplanes 
that are approaching or have exceeded their design service goal. This 
rulemaking would require a limit of validity in flight cycles or hours 
of the structural maintenance program, where the operator must 
incorporate added inspections and/or

[[Page 64214]]

modification/replacement actions into its maintenance program to allow 
continued operation.


Statement of Need:


History has shown that widespread fatigue damage (WFD) is a significant 
safety risk for transport category airplanes. The Aloha B-737 accident 
in 1988 showed FAA and industry that WFD could be a problem that could 
lead to catastrophic failure of airplane structure. Numerous widespread 
fatigue damage incidents since then have confirmed that it is a threat 
common to all aging airplanes. Because widespread fatigue damage 
results from the interaction of many small cracks, existing inspection 
methods are inadequate to reliably detect and prevent it.


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 acknowledges the proposed rule may have a significant impact on 
a substantial number of small entities. We conclude the current 
proposal is the preferred alternative because it provides for a common 
WFD system for all operators who fly in the same airspace under the 
same operating environment. We considered the following alternatives: 
(1) Exclude small entities; (2) extend the compliance deadline for 
small entities; (3) establish lesser technical requirements for small 
entities; and (4) expand the requirements to cover more airplanes.


Anticipated Cost and Benefits:


The cost of this proposal is $358.1 million. The benefits of this 
proposal consist of $654 million in accident prevention benefits and 
$74 million in detection benefits, for total benefits of $728 million.


Risks:


Because widespread fatigue damage problems will occur as airplanes 
operate beyond their initial operational limit, operators are likely to 
detect such problems over the 20-year forecast period. The FAA has 
assumed that there is a probability of widespread fatigue damage 
problems occurring for each fuselage type of five percent in each year. 
Under this assumption, there is a 35 percent chance that there will be 
zero WFD problems detected for a particular fuselage type over a 20-
year period.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            02/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Brent Bandley
ANM-120L
Department of Transportation
Federal Aviation Administration
3960 Paramount Boulevard
Lakewood, CA 90712-4137
Phone: 562-627-5237
Fax: 562-627-5210
Email: [email protected]
RIN: 2120-AI05
_______________________________________________________________________



DOT--FAA



89. [rplus]TRANSPORT AIRPLANE FUEL TANK FLAMMABILITY REDUCTION

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 44701-44702; 49 USC 44704


CFR Citation:


14 CFR 25


Legal Deadline:


None


Abstract:


This rulemaking will require that flammability reduction means be 
incorporated into existing airplanes, newly manufactured airplanes, and 
new designs. It establishes new design standards for future and pending 
applications for type certification as well as new operating rules for 
retrofitting existing airplanes.


Statement of Need:


There have been four accidents caused by fuel tank explosions since 
1989. Two occurred during flight and two others occurred on the ground. 
Terrorists caused one of the four. In the other three cases, no 
ignition source was identified as the cause of the explosion. In all 
four cases, however, investigators concluded that the center wing fuel 
tank in these airplanes contained flammable vapors when the fuel tanks 
exploded and the accidents occurred.


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:


1. Require flammability reduction means on new production and new 
designs without requiring retrofit. The risk analysis for this option 
predicted an unacceptable high number of future accidents due to the 
high number of airplanes within the current fleet that would remain in 
service for many years. 2. Require inerting of all fuel tanks on 
existing airplanes in the fleet and new type designs. 3. Exclude all 
cargo operators. 4. Address unsafe condition through airworthiness 
directive. 5. Impose changes on operators as opposed to requiring OEMs 
to develop design changes. Past experience on similar safety 
initiatives shows the OEMs do not consistently support these efforts 
and place an undue burden on the operators.


Anticipated Cost and Benefits:


The FAA is conducting a regulatory evaluation using various 
combinations of the value of a human life, the timing of the next 
accidents, the passenger load on the next accident airplane, and the 
effectiveness of SFAR 88. We anticipate costs and benefits will vary 
based upon assumptions used in calculating these values. Using a value 
of 3 million per life, average airplane size, average time for the next 
accident, the costs could exceed $1 billion and quantitative benefits 
will be less than $1 billion.


Risks:


The FAA believes at least one and as many as five accidents will happen 
in the next 50 years.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

[[Page 64215]]

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Mike Dostert
Department of Transportation
Federal Aviation Administration
1601 Lind Avenue SW.
Renton, WA 98055
Phone: 425 227-2132
Fax: 425 227-1320
Email: [email protected]
RIN: 2120-AI23
_______________________________________________________________________



DOT--FAA



90. [rplus]ENHANCED AIRWORTHINESS PROGRAM FOR AIRPLANE SYSTEMS (EAPAS) 
AND SFAR 88

Priority:


Other Significant


Legal Authority:


49 USC 106(g); 49 USC 1155; 49 USC 1372; 49 USC 40103; 49 USC 40119; 49 
USC 40120; 49 USC 106(g); 49 USC 40103; 49 USC 40113; 49 USC 40119 to 
40120; 49 USC 41706; 49 USC 4401; 49 USC 44111; 49 USC 44701 to 44705; 
49 USC 44709 to 44713; 49 USC 44715 to 44717


CFR Citation:


14 CFR 1; 14 CFR 25; 14 CFR 91; 14 CFR 121; 14 CFR 125; 14 CFR 129; 14 
CFR 1; 14 CFR 121; 14 CFR 129; 14 CFR 25; 14 CFR 91


Legal Deadline:


None


Abstract:


This rulemaking would change wiring system and fuel tank system 
requirements for transport category airplanes. It would organize and 
clarify design requirements for wire systems, by moving existing 
regulatory references to wiring into a single section of the 
regulations specifically for wiring and adding new certification rules 
to address aging issues in wire systems. This rulemaking would require 
holders of type certificates for certain transport category airplanes 
to conduct analyses and make necessary changes to existing Instruction 
for Continued Airworthiness (ICA) to improve maintenance procedures for 
wire systems. It would require operators to incorporate those ICA for 
wiring into their maintenance or inspection programs. It would also 
clarify requirements of certain existing operational rules for 
operators to incorporate ICA for fuel tank systems into their 
maintenance or inspection programs. The intent of this rule is to help 
ensure the continued safety of commercial airplanes by improving the 
design, installation, and maintenance of their electrical wiring 
systems as well as by aligning those requirements as closely as 
possible with the requirements for fuel tank system safety.


Statement of Need:


The proposal will address a continuing history of wire-related 
failures, resulting in smoke in the cabin/flight deck, fires, arcing, 
etc. Current maintenance practices have not been adequate to address 
issues of aging and degradation in wiring. Wires have not been viewed 
as important systems on their own.


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:


1. Require operators to clean and inspect each airplane every C-check 
or every three years, causing an additional $192.5 million in cleaning 
and inspection costs, and an additional $104.0 million in downtime. 
This option would result in additional costs of $296.5 million with no 
commensurate increase in benefits. 2. Require electrical wiring 
interconnection systems training for four new groups of people 
(electrical/avionic engineers, individuals involved in engineering or 
planning work, flight deck crew, and cabin crew, in addition to 
maintenance workers. Training these individuals would require that 
operators develop additional courses. The total estimated additional 
cost of this alternative is approximately $381.1 million with no 
commensurate increase in benefits. 3. We also considered voluntary 
compliance with the intent of this proposal by the affected parties. 
Some in industry have suggested issuing advisory circulars to give 
guidance on changes that need to be made. However, previous voluntary 
safety assessments have been difficult to complete in a timely manner 
because they lack enforceability. Similarly, issuance of guidance 
material would depend on voluntary compliance, and would not be 
enforceable.


Anticipated Cost and Benefits:


Total costs are estimated at $474.3 million (209.2 million in present 
value) over 25 years. Total benefits are estimated at $755.3 million 
($340.7 million in present value) over 25 years.


Risks:


The FAA estimates there may be more than 1.2 fatal events caused by 
electrical wiring interconnection systems (EWIS) over a 25-year period. 
The Poisson distribution provides a measure for this risk. Based on a 
mean value of 1.2 fatal EWIS events, there is a 70 percent chance there 
will be 1 or more occurrences of a fatal EWIS event, a 34 percent 
chance there will be 2 or more fatal EWIS events; and a 12 percent 
chance of 3 or more occurrences of fatal EWIS events.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/06/05                    70 FR 58508
NPRM Comment Period End         02/03/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Fred Sobeck
Federal Aviation Administration
Department of Transportation
Federal Aviation Administration
800 Independence Ave, SW.
Washington, DC 20591
Phone: 202 267-7355
Fax: 202 267-7335
Email: [email protected]
RIN: 2120-AI31

[[Page 64216]]

_______________________________________________________________________



DOT--FAA



91. [rplus]AGING AIRCRAFT SAFETY--DEVELOPMENT OF TC AND STC HOLDER DATA

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


49 USC 106(g); 49 USC 40113; 49 USC 44701; 49 USC 44702; 49 USC 44704


CFR Citation:


14 CFR 25


Legal Deadline:


None


Abstract:


This rulemaking would require type certificate holders and supplemental 
type certificate holders to provide airplane operators with damage 
tolerance data for repairs, alterations, and modifications to certain 
airplane structure. This rulemaking is needed to support airplane 
operator compliance with the requirement to include damage tolerance 
inspections and procedures in their maintenance programs. The intended 
effect of this rulemaking is twofold. First, it is to ensure the 
continued airworthiness of airplane structure that is susceptible to 
fatigue cracking that could contribute to a catastrophic failure. 
Second, it would require that type certificate holders and supplemental 
type certificate holders provide needed data to support operator 
compliance with the Aging Airplane Safety final rule.


Statement of Need:


In several recent rules the FAA has adopted operational requirements 
without a corresponding requirement for design approval holders to 
develop and provide the necessary data and documents to support 
operator compliance. The difficulty encountered by operators in 
complying with these rules has convinced us that corresponding design 
approval holder requirements are necessary to enable operators to 
comply by the regulatory deadlines.


Summary of Legal Basis:


Section 44704, 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:


Issuance of guidance material would depend on voluntary compliance and 
would not be enforceable.


Anticipated Cost and Benefits:


Not yet determined.


Risks:


Without a regulatory requirement imposed on design approval holders, 
operators would have to rely on voluntary compliance by design approval 
holders to provide data operators needed to comply with the regulatory 
requirement to develop damage tolerance programs required by the Aging 
Airplane Safety rule.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/00/05

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Greg Schneider
Federal Aviation Administration
Department of Transportation
Federal Aviation Administration
1601 Lind Avenue SW.
Renton, WA 98055
Phone: 425 227-2116
Fax: 425 227-1181
Email: [email protected]
RIN: 2120-AI32
_______________________________________________________________________



DOT--Federal Motor Carrier Safety Administration (FMCSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




92. [rplus]MEDICAL CERTIFICATION REQUIREMENTS AS PART OF THE CDL

Priority:


Other Significant


Legal Authority:


PL 106-159 sec 215; 113 Stat. 1748, 1767 (1999); 49 USC 31305 note and 
31502


CFR Citation:


49 CFR 383, 384, and 391


Legal Deadline:


None


Abstract:


This rulemaking would provide for a Federal medical certification as 
part of the commercial driver's license (CDL) program, as required by 
Section 215 of the Motor Carrier Safety Improvement Act. Incorporating 
medical qualification verification and documentation into State-
administered CDL procedures will improve highway safety by preventing 
medically unqualified individuals from obtaining a CDL. It would also 
eliminate the requirement for CDL operators to carry their medical 
certificate in addition to their CDL.


Statement of Need:


This rule is required by Public Law 106-159. Section 215 of the Act 
requires combining the medical certification with the CDL. When 
applying for (or renewing) a CDL, commercial motor vehicle (CMV) 
drivers are not currently required to present the medical certificate 
or provide State licensing agencies with a copy of the medical 
certificate as proof of physical qualifications to operate CMVs in 
interstate commerce. Drivers are usually allowed to self-certify their 
physical qualifications by checking the appropriate box on the CDL 
application form. This rulemaking would require CDL holders who operate 
CMVs in interstate commerce to provide the actual medical certificate 
or identical copy to the State licensing agency, thus eliminating the 
States' reliance on driver self-certification.


Summary of Legal Basis:


Section 215 of the Motor Carrier Safety Improvement Action of 1999 
(MCSIA) directed the Secretary of Transportation (Secretary) to 
``initiate a rulemaking to provide for a Federal medical qualification 
certificate to be made part of commercial driver's licenses.'' The 
physical qualifications requirements in 49 CFR part 391 are based on 49 
U.S.C. 31136 and 31502. The physical qualifications standards are at 49 
CFR 391.11. Part 391 regulations are applicable only to drivers who 
operate CMVs, as defined in 49 U.S.C. 31132. Thus, FMCSA interprets 
section 215 of MCSIA applicable only to interstate

[[Page 64217]]

CDL holders.The Commercial Motor Vehicle Safety Act of 1986 directed 
the Secretary to establish licensing standards for drivers that operate 
CMVs as defined in 49 U.S.C. 31301. Those operators of CMVs as defined 
in 49 U.S.C. 31301, who are engaged solely in intrastate commerce, must 
obtain a CDL but are not required by current Federal regulations to 
obtain a medical certificate as proof of their physical qualifications 
to operate commercial vehicles. [49 CFR 383.71(a)(1)]. The Secretary 
delegated these authorities to FMCSA. [49 CFR 1.73].


Alternatives:


The alternative was mandatory electronic filing of medical certificates 
from the medical examiner to the State. A national, automated audit 
system would be used to centrally monitor medical examiner performance 
problems, including driver physical qualification examination outcomes, 
in States. Each of the 51 CDL licensing jurisdictions would be required 
to examine a sampling of reported problems in the national data system, 
and meet quality control standards established by the Agency. Driver 
medical certification status would be available for licensing, 
enforcement, and employment. The States would have borne the majority 
of costs associated with this model.


Anticipated Cost and Benefits:


A preliminary regulatory evaluation is under development and will be 
released on the date the NPRM is published.


Risks:


In addition to assessing costs, the agency is assessing the safety 
benefits.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           07/15/94                    59 FR 36338
ANPRM Comment Period End        11/14/94
NPRM                            03/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions


Government Levels Affected:


Undetermined


Additional Information:


Docket No. FMCSA-97-2210.


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Dr. Mary D. Gunnels
Chief, Physical Qualifications Division (MC-PSP)
Department of Transportation
Federal Motor Carrier Safety Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4001
Email: maggi..[email protected]
RIN: 2126-AA10
_______________________________________________________________________



DOT--FMCSA

                              -----------

                            FINAL RULE STAGE

                              -----------




93. [rplus]UNIFIED REGISTRATION SYSTEM

Priority:


Other Significant


Legal Authority:


PL 104-88; 109 Stat. 803, 888 (1995); 49 USC 13908


CFR Citation:


49 CFR 360, 365, 366, 368, 387, and 390


Legal Deadline:


Final, Statutory, January 1, 1998.


Abstract:


This rulemaking would replace three current identification and 
registration systems -- the US DOT identification number system, the 
registration/licensing system, and the financial responsibility system 
-- with a unified registration system. It would consolidate and 
simplify current Federal registration processes and increase public 
accessibility to data about interstate and foreign motor carriers, 
property brokers, and freight forwarders. In addition, the agency is 
considering how it might replace a fourth system -- the single-State 
registration system -- in a manner consistent with conditions imposed 
by statute.


Statement of Need:


As a result of the ICC Termination Act of 1995 [Public Law 104-88, 
December 29, 1995, 109 Stat. 888] (ICCTA), Congress terminated the 
Interstate Commerce Commission and transferred its functions concerning 
licensing and financial responsibility requirements to the DOT. 
Congress mandated that the agency consider unifying the four current 
systems with a single, on-line Federal system.


Summary of Legal Basis:


The ICCTA created a new 49 U.S.C. 13908 directing ``the Secretary, in 
cooperation with the States, and after notice and opportunity for 
public comment,'' . . . to ``issue regulations to replace the current 
DOT identification number system, the single State registration system 
under section 14504, the registration system contained in this chapter, 
and the financial responsibility information system under section 13906 
with a single, on-line, Federal system.''


Alternatives:


FMCSA considered several alternatives to the proposal discussed here, 
in an effort to minimize the potential new filing burden on small 
entities which comprise 80% of motor carriers. For instance, we 
considered exempting existing carriers from certain new filing 
requirements (via a grandfather clause), with the idea that it would 
minimize the compliance costs of this proposal. However, while reducing 
compliance costs (and thereby improving filing efficiency), it would 
also have reduced, not enhanced, the fairness of the motor carrier 
registration process relative to the status quo by placing higher 
burdens on new entrants than existing carriers. As such, it would have 
acted as a barrier to entry to small new entrants to the benefit of 
existing carriers. Conversely, we also considered exempting new 
entrants from these requirements, but dismissed this on the grounds 
that it too would have reduced the fairness of the registration 
process. Additionally, either option would have reduced safety relative 
to the proposal discussed here. The agency also considered removing the 
process agent designation filing requirement on the grounds that it was 
the most costly of the initiatives in this proposal. However, the 
agency dismissed this option because FMCSA division administrators felt 
that this particular filing requirement had the best potential to 
increase industry safety by improving the productivity of the agency's 
safety investigators (thereby allowing them to initiate additional 
compliance reviews). Additionally, the process agent designation filing 
requirement also enhances the fairness of the agency's registration 
process.


Anticipated Cost and Benefits:


Total discounted costs of the proposed rule equal $75.4 million over 
the 10-

[[Page 64218]]

year analysis period. In examining the overall burden of the NPRM to 
small entities, the agency countered some new (cost inducing) proposals 
with several actions that would reduce the filing burden of new entrant 
and existing motor carriers. The cost savings would partially offset 
the compliance costs, resulting in average total compliance costs of 
$48 per new entrant and $42 per existing carrier in any single year of 
the 10-year analysis period. Since costs are expected to reduce pre-tax 
profits of small entities by less than 1 percent in a given year, the 
agency believes the impact on small entities has effectively been 
minimized with the current proposal, while trying to meet its stated 
goals and Congress' mandate. Benefits from the proposed rule include 
crash-related benefits from avoided crashes as well as time/cost 
savings associated with a reduced filing burden and/or reduced FMCSA 
fees paid by motor carriers. Total first-year benefits of the proposal 
would be $9.3 million (discounted), while total discounted benefits are 
estimated at $91.4 million over the 10-year analysis period. Comments 
were requested on this subject in the NPRM.


Risks:


The proposed rule is intended to streamline the registration process 
and ensure that FMCSA can more efficiently track CMVs and ensure their 
safe operation. The Unified Registration System imposes no operational 
responsibilities on drivers. Therefore, the proposed regulation would 
not impair a driver's ability to operate vehicles safety; would not 
impact the physical condition of drivers; and would not have a 
deleterious effect on the physical condition of drivers, in accordance 
with the statutory mandate of 49 U.S.C. 31136 (a).


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           08/26/96                    61 FR 43816
ANPRM Comment Period End        10/25/96
NPRM                            05/19/05                    70 FR 28990
NPRM Comment Period End         08/17/05
Final Action                    06/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal, State


Additional Information:


Docket No. FMCSA-97-2349.


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Valerie Height
Transportation Specialist, Office of Policy Plans and Regulation (MC-
PRR)
Department of Transportation
Federal Motor Carrier Safety Administration
MC-PRR
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-0901
RIN: 2126-AA22
_______________________________________________________________________



DOT--National Highway Traffic Safety Administration (NHTSA)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




94. [rplus]REDUCED STOPPING DISTANCE REQUIREMENTS FOR TRUCK TRACTORS

Priority:


Other Significant


Legal Authority:


49 CFR 1.50; 49 USC 30111; 49 USC 30115; 49 USC 30117; 49 USC 30166; 49 
USC 322


CFR Citation:


49 CFR 571.121


Legal Deadline:


None


Abstract:


The agency is considering reducing stopping distance requirements for 
truck tractors equipped with air brake systems. Advances in heavy 
vehicle braking systems show that improved stopping performance is 
attainable for these vehicles. Such improvements would reduce the 
stopping distance disparity with light vehicles, and would result in 
fewer deaths and injuries and reduce property damage due to fewer 
crashes between truck tractors and light vehicles.


Statement of Need:


Large trucks have longer stopping distances than light vehicles, 
increasing the chance of crashes in panic stopping situations. Crash 
data show that combination unit trucks (e.g., tractor-trailers) are 
highly involved in large truck fatal crashes with light vehicles. 
Agency test results indicate that significantly reduced tractor 
stopping distances may be achieved by using current-technology brake 
systems. The agency believes that sufficient test data exists to move 
forward with a proposal.


Summary of Legal Basis:


Section 30111, Title 49 of the USC, states that the Secretary shall 
prescribe motor vehicle safety standards.


Alternatives:


The agency is not pursuing any alternatives to reduce stopping 
distances for this type of vehicle other than changes in the 
requirements in FMVSS No. 121.


Anticipated Cost and Benefits:


Reducing the stopping distance requirements (service brakes and/or 
emergency brakes) for tractors in FMVSS No. 121, Air Brake Systems, by 
20 to 30 percent is expected to reduce unable-to-stop-in-time 
collisions between combination-unit trucks and light vehicles. Test 
data has indicated that stopping distance reductions of up to 30 
percent may be achievable for all tractors in FMVSS No. 121. Evaluation 
is underway to determine the reductions in deaths, injuries, and 
property damage that could result from reductions in tractor stopping 
distances.


Risks:


The agency believes there are no substantial risks to this rulemaking, 
and that only beneficial outcomes will occur as the industry moves to 
improved tractor braking systems.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

[[Page 64219]]

Agency Contact:
Jeffrey Woods
Safety Standards Engineer Office of Crash Avoidance Standards
Department of Transportation
National Highway Traffic Safety Administration
NVS-122
Vehicle Dynamics Division
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-2720
Fax: 202 366-4329
RIN: 2127-AJ37
_______________________________________________________________________



DOT--NHTSA



95. [rplus]LIGHT TRUCK AVERAGE FUEL ECONOMY STANDARDS, MODEL YEAR 2008 
AND POSSIBLY BEYOND

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


15 USC 2002; Delegation of Authority at 49 CFR 1.50


CFR Citation:


49 CFR 533


Legal Deadline:


Final, Statutory, April 1, 2006, CAFE standards must be set at least 18 
months prior to the start of a model year.


Abstract:


This rulemaking would address Corporate Average Fuel Economy Standards 
for light trucks for model year 2008 and possibly beyond, as 
appropriate.


Statement of Need:


NHTSA is required by statute to establish the CAFE standard for a model 
year not later than 18 months before its beginning, and thus must 
publish the final rule for model year 2008 on or before April 1, 2006.


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 agency is also considering reform of the structure of the CAFE 
program under Reforming the Automobile Fuel Economy Standards Program 
(2127-AJ17).


Anticipated Cost and Benefits:


The costs and benefits of the potential changes addressed in this 
action have not yet been assessed.


Risks:


Depending on how manufacturers address Federal fuel economy 
requirements, there is some potential effect on safety. The most recent 
NHTSA analysis (2003) indicated that the association between vehicle 
weight and overall crash fatality rates in heavier MY 1991-99 light 
trucks and vans was not significant. However, for three other groups of 
MY 1991-99 vehicles - the lighter LTVs (light trucks and vans), the 
heavier cars, and especially the lighter cars - fatality rates 
increased as weights decreased.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            08/30/05                    70 FR 51414
NPRM Comment Period End         11/22/05
Final Rule                      04/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Energy Effects:


 Statement of Energy Effects planned as required by Executive Order 
13211.


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Kenneth R. Katz
Lead Engineer, Consumer Program Division
Department of Transportation
National Highway Traffic Safety Administration
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4936
Fax: 202 366-4329
Email: [email protected]
RIN: 2127-AJ61
_______________________________________________________________________



DOT--NHTSA

                              -----------

                            FINAL RULE STAGE

                              -----------




96. [rplus]5TH PERCENTILE DUMMY BELTED BARRIER CRASH TEST REQUIREMENTS 
-- STANDARD 208

Priority:


Other Significant


Legal Authority:


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


CFR Citation:


49 CFR 571.208


Legal Deadline:


None


Abstract:


The agency is considering an amendment to its occupant protection 
standard, FMVSS No. 208, to improve high speed crash protection to 
belted occupants of small stature who may sit in the full forward seat 
position. Current crash test requirements for the 5th percentile adult 
female dummy include a 0-48 km/h belted rigid barrier crash test. The 
agency is considering increasing the maximum crash test speed from 48 
km/h to 56 km/h to be consistent with the 50th percentile adult male 
requirements that will take effect according to the second phase of the 
FMVSS No. 208 Advanced Air Bag Final Rule (65 FR 30680).


Statement of Need:


In May 2000, NHTSA upgraded the requirements in FMVSS No. 208 for air 
bags in passenger cars and light trucks, to be phased in beginning in 
the 2004 model year. The upgrade was designed to meet the goals of 
improving protection for occupants of all sizes, belted and unbelted, 
in moderate to high speed crashes, and of minimizing the risks posed by 
air bags to infants, children, and other occupants, especially in low 
speed crashes. The rule included a requirement that, beginning in 2007, 
the 50th percentile adult dummy must meet the injury criteria when 
subjected to a 35 mph belted rigid barrier crash. The Agency stated 
that there was insufficient data to incorporate the 5th percentile 
female dummy into the 35 mph crash, but that additional testing would 
be conducted to determine the feasibility of including it. That testing 
was completed, and NHTSA published an NPRM on August 6, 2003, proposing 
requirements that

[[Page 64220]]

the belted 5th percentile female dummy pass the injury criteria when 
subjected to a 35 mph rigid barrier crash. It is important to include 
this dummy in the requirements for FMVSS No. 208 in order to achieve 
the full intended benefits of advanced air bag requirements.


Summary of Legal Basis:


Section 30111, title 49 of the U.S.C., states that Secretary shall 
prescribe motor vehicle safety standards.


Alternatives:


The agency will examine existing test procedures, analyze alternative 
approaches proposed by commenters to the NPRM, evaluate alternative 
international approaches, and keep abreast of the development of new 
occupant protection technologies specific to small stature occupants.


Anticipated Cost and Benefits:


The NPRM estimated that the proposed requirements, if adopted, could 
prevent between 5 and 6 small occupant fatalities per year and could 
also reduce two to three moderate-to-severe injuries yearly and would 
result in a nominal additional cost to vehicle manufacturers. Based on 
the comments to the NPRM, the agency is re-evaluating the benefits and 
costs associated with requiring a higher speed belted barrier crash 
test by including an evaluation of advanced air bag-equipped vehicles.


Risks:


The proposed amendment will upgrade the performance requirements of the 
standard such that FMVSS No. 208 will require the same level of high 
speed crash protection for small statured occupants as for larger 
occupants. The full intended benefits of the standard may not be 
achieved if we did not include this segment of the population.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            08/06/03                    68 FR 46539
Final Rule                      01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Lori Summers
Chief, Light Duty Vehicle Division
Department of Transportation
National Highway Traffic Safety Administration
NVS-112
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4917
Fax: 202 366-4329
Email: [email protected]
RIN: 2127-AI98
_______________________________________________________________________



DOT--NHTSA



97. [rplus]SIDE IMPACT PROTECTION UPGRADE - FMVSS NO. 214

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


49 USC 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. This rulemaking would require 
in FMVSS No. 214 a vehicle-to-pole oblique impact test to reduce the 
number of fatal and serious head injuries, which are 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 has proposed 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.


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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            05/14/04                    69 FR 27990
NPRM Comment Period End         10/14/04
NPRM Comment Period 
    Extended                    01/12/05                     70 FR 2105
NPRM Comment Period 
    Extended To                 04/12/05
Final Rule                      03/00/06

[[Page 64221]]

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


URL For More Information:
dms.dot.gov

URL For Public Comments:
dms.dot.gov

Agency Contact:
Lori Summers
Chief, Light Duty Vehicle Division
Department of Transportation
National Highway Traffic Safety Administration
NVS-112
400 Seventh Street SW.
Washington, DC 20590
Phone: 202 366-4917
Fax: 202 366-4329
Email: [email protected]
Related RIN: Related to 2127-AJ16, Related to 2127-AI89
RIN: 2127-AJ10
BILLING CODE 4910-62-S

[[Page 64222]]




DEPARTMENT OF THE TREASURY (TREAS)



Statement of Regulatory Priorities
 The primary missions of the Department of the Treasury are:
 To promote prosperous and stable American and world 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.
 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.
 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. Since then, 
the Department 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. Since the Act currently is scheduled to expire on December 
31, 2005, no regulatory activity is planned for the coming year.
 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 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 program that provides a system of shared public and 
private compensation for insured losses resulting from certain types of 
terrorist acts.
 Over the past year, the Office of the Assistant Secretary has 
continued the ongoing work of quickly implementing TRIA. The Office has 
refined regulations and procedures for filing claims under TRIA and is 
developing regulations for recouping the Federal share of compensation 
to insurers through risk-spreading premiums. If TRIA is extended beyond 
its scheduled expiration date of December 31, 2005, the Office will 
continue its ongoing work to implement the Act. If TRIA is not 
extended, the Office will work to close the Program.
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 (CBP). 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 2006, Treasury and CBP plan to finalize several 
interim regulations involving the customs revenue functions not 
delegated to DHS. Among these are the following interim regulations 
that implement the trade benefit provisions of the Trade Act of 2002:
 The Andean Trade Promotion and Drug Eradication Act
 The Caribbean Basin Economic Recovery Act
 The African Growth and Opportunity Act
 CBP also plans to finalize interim regulations this fiscal year to 
implement the preferential trade benefit provisions of the United 
States-Chile Free Trade Agreement Implementation Act and to issue 
interim regulations implementing the United States-Singapore Free Trade 
Agreement Implementation Act.
 In addition, Treasury and CBP plan to propose uniform rules governing 
the determination of the country of origin of

[[Page 64223]]

imported merchandise. The uniform rules would extend the application of 
the North American Free Trade Agreement country of origin rules to all 
trade.
 Another project CBP will be working on finalizing this fiscal year is 
a proposal that would allow CBP to be more responsive to claims of 
piracy of copyrighted works. This rule would allow sound recordings and 
motion pictures or similar audio-visual works to be recorded with CBP 
while pending registration with the U.S. Copyright Office, and would 
allow recordation of all non-U.S. works without requiring registration 
with the U.S. Copyright Office.
 Treasury and CBP 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. CBP 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 a variety of programs: the Community Development 
Financial Institutions (CDFI) Program, the Bank Enterprise Award (BEA) 
Program, and the New Markets Tax Credit (NMTC) Program.
 In fiscal year 2006, the CDFI Program will comprise: (i) financial 
assistance awards and (ii) technical assistance grants. In addition, 
the Fund administers the Native American CDFI Assistance (NACA) 
Program, through which the Fund provides technical assistance grants 
and financial assistance awards to promote the development of CDFIs 
that serve Native American, Alaska Native, and Native Hawaiian 
communities.
 Through the BEA Program, the Fund provides financial incentives to 
encourage insured depository institutions to engage in eligible 
development activities and to make equity investments in CDFIs.
 In addition, the Fund administers the 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. Through 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 2006 regulatory priority will include a 
revision of the regulations governing the CDFI Program.
Financial Crimes Enforcement Network
 The Financial Crimes Enforcement Network (FinCEN) is the administrator 
of the Bank Secrecy Act (BSA) and FinCEN's regulations constitute the 
core of the Department's anti-money laundering initiatives and are an 
essential component of the Department's anti-terrorist financing and 
anti-narcotics efforts.
 FinCEN's responsibilities and objectives are keyed to and flow from 
that role. 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 has established regulatory objectives and 
priorities that implement its mission to safeguard the financial system 
from the abuses of financial crime, including terrorist financing, 
money laundering, and other illicit activity. These objectives include: 
issuing, interpreting, and enforcing compliance with regulations 
implementing the BSA; supporting and overseeing compliance examination 
functions delegated to other federal regulators; managing the 
collection, processing, storage, and dissemination of data related to 
the BSA; maintaining a government-wide access service to that same 
data, and for network users with overlapping interests; conducting 
analysis in support of policy makers, law enforcement, regulatory and 
intelligence agencies, and the financial industry; and, coordinating 
with and collaborating on anti-terrorism and anti-money laundering 
initiatives with domestic law enforcement and intelligence agencies, 
and with foreign financial intelligence units.
 Significant rules issued during fiscal year 2005 include an interim 
final rule requiring dealers in precious metals, stones, or jewels to 
establish anti-money laundering programs, and several rules proposing 
imposition of special measures pursuant to Section 311 of the USA 
PATRIOT Act.
 FinCEN's regulatory priorities for fiscal year 2006 include the 
following projects:
 Due Diligence for Correspondent Accounts and Private 
            Banking Accounts. To the extent that a final rule has not 
            been adopted in the fourth quarter of 2005, FinCEN expects 
            to finalize a rule implementing 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.
 Anti-Money Laundering Programs. Under Section 352 of 
            the USA PATRIOT Act, certain financial institutions are 
            required to establish anti-money laundering programs. To 
            the extent that final rules have not been adopted in the 
            fourth quarter of 2005, FinCEN expects to finalize anti-
            money laundering program rules proposed in September 2002 
            for insurance companies and unregistered investment 
            companies and rules proposed in May 2003 for investment 
            advisers and commodity trading advisers. FinCEN expects to 
            issue a proposed rule for loan or finance companies 
            (including pawnbrokers). FinCEN also expects to consider 
            issuing a proposed rule requiring certain corporate and 
            trust service providers to establish anti-money laundering 
            programs. Finally, FinCEN will determine whether to issue 
            proposed rules for other financial institutions vehicle 
            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.
 Suspicious Activity Reporting. To the extent that 
            final rules have not been

[[Page 64224]]

            adopted in the fourth quarter of 2005, the FinCEN expects 
            to finalize several rules proposed under 31 U.S.C. 5318(g) 
            requiring insurance companies and mutual funds to report 
            suspicious transactions.
Other Requirements. FinCEN expects to issue a proposal to require all 
money services businesses, including agents, to register. FinCEN will 
also issue a proposed rule that would require all financial 
institutions that file BSA reports to do so electronically, if 
technically able. It will consider the need for regulatory action in 
conjunction with the feasibility study being prepared pursuant to the 
Intelligence Reform Bill concerning the issue of obtaining information 
about certain cross-border transmittals of funds. FinCEN will continue 
to issue proposed and final rules pursuant to Section 311 of the USA 
PATRIOT Act, as appropriate. Finally, FinCEN expects to propose various 
technical and other regulatory amendments in conjunction with its 
ongoing, comprehensive review of existing regulations.
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.
 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 2006 the Internal Revenue Service will accord 
priority to the following regulatory projects:
 Deductibility of Subsidiary Stock Loss by Members of 
            Consolidated Groups. On March 14, 2003, the IRS and 
            Treasury issued temporary regulations (Treas. Reg. Sec.  
            1.1502-35T) to prevent consolidated groups from obtaining 
            more than one tax benefit from a single economic loss. On 
            March 3, 2005, the IRS and Treasury issued final 
            regulations (Treas. Reg. Sec.  1.337(d)-2) to prevent 
            consolidated groups from avoiding the corporate tax on 
            appreciated assets (and thereby circumventing the repeal of 
            the General Utilities doctrine) through the recognition of 
            noneconomic losses on subsidiary stock. The preamble to 
            Treas. Reg. Sec.  1.337(d)-2 stated that those regulations 
            were an interim measure pending the proposal of another 
            method for addressing General Utilities repeal in the 
            consolidated return setting. During fiscal year 2006, the 
            IRS and Treasury plan to reexamine the approach taken in 
            both these regulations.
 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, debt, certain derivative financial 
            instruments, or other securities to mark their securities 
            to market at the end of each tax year. That is, those 
            dealers must compute their taxable income by including 
            their securities in inventory at their fair market value 
            and, if their securities are not inventory, recognizing 
            gain or loss as if their securities had been sold for their 
            fair market value at the end of the tax year. Dealers and 
            traders in commodities, and securities traders are not 
            required to use mark-to-market accounting but may elect to 
            do so. The IRS and Treasury issued proposed regulations on 
            May 24, 2005, that allow dealers in securities (and 
            electing dealers in commodities or traders in securities or 
            commodities) to use the safe harbor method to satisfy the 
            statutory requirement to determine the fair market value of 
            items marked to market. The safe harbor method set forth in 
            the proposed regulations permits taxpayers to use as fair 
            market value for section 475 purposes the value used on 
            certain financial statements, if certain conditions are 
            met. In addition, there are some limitations on the use of 
            the safe harbor method in situations where fair market 
            value and financial accounting fair value principles are 
            not sufficiently consistent. The IRS and Treasury intend to 
            finalize these regulations during fiscal year 2006.
 Capitalization of Interest and Carrying Charges 
            Properly Allocable to Straddles. Section 1092 of the 
            Internal Revenue Code limits loss recognition on one leg of 
            a straddle if there is unrecognized gain with respect to 
            one or more offsetting positions. Section 263(g) disallows 
            a deduction for interest and carrying charges properly 
            allocable to personal property that is part of a straddle. 
            The IRS and Treasury expect to 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 are expected to address the 
            definition of personal property for purposes of section 
            263(g) of the Internal Revenue Code, the types of expenses 
            subject to capitalization, and the operation of the 
            capitalization rules. In addition, the regulations will 
            indicate when the debtor's position in a debt instrument 
            will be treated as a position in personal property that may 
            be part of a straddle. The regulations are also expected to 
            clarify the application of the straddle anti-abuse rules to 
            various financial instruments and straddle transactions.
 Deduction and Capitalization of Costs for Tangible 
            Assets. Section 162 of the Internal Revenue Code allows a 
            current deduction for ordinary and necessary expenses paid 
            or incurred in carrying on any trade or business. Under 
            section 263(a) of the Code, no immediate deduction is 
            allowed for amounts paid out for new buildings or for 
            permanent improvements or betterments made to increase the 
            value of any property or estate. Those 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. It often is not clear whether 
            an expenditure to repair, improve, or rehabilitate property 
            is a deductible expense or a capital expenditure. Although 
            existing regulations provide that a deductible repair 
            expense is an expenditure that does not materially add to 
            the value of the property nor appreciably prolong its life, 
            the IRS and Treasury believe that additional clarification 
            is needed to reduce uncertainty and controversy in this 
            area. In December 2003, the IRS and Treasury requested 
            public comment on rules that might be provided to clarify 
            the application of section 263(a) to repairs and 
            improvements to tangible property. During fiscal year 2006, 
            the IRS and Treasury intend to propose regulations in this 
            area.
 Foreign Tax Credit Guidance Initiatives. Treasury 
            and the IRS anticipate issuing guidance under

[[Page 64225]]

            section 901 and other provisions of the Internal Revenue 
            Code during fiscal year 2006 to address the proper 
            interaction of foreign income tax regimes and the U.S. 
            foreign tax credit. The guidance will address the operation 
            of the U.S. foreign tax credit rules in the context of 
            foreign affiliated group structures whose income tax 
            results are combined for foreign income tax purposes. The 
            guidance will also address the U.S. foreign tax credit 
            consequences of certain so-called hybrid entities that are 
            treated as separate taxable entities for foreign, but not 
            U.S., tax purposes. Additional guidance will provide rules 
            relating to the effect of foreign tax redeterminations and 
            other provisions added by the American Jobs Creation Act of 
            2004 (AJCA). The guidance will provide for tax treatment 
            that is consistent with the policies of the foreign tax 
            credit provisions and applicable law.
 Deduction for Qualified Production Activities Income. Section 
            199 of the Internal Revenue Code allows taxpayers to deduct 
            a percentage of income derived from qualified production 
            activities performed in the U.S. The IRS and Treasury 
            issued Notice 2005-14 in January 2005 to provide interim 
            guidance on issues relating to section 199, pending the 
            issuance of regulations. During fiscal year 2006, the IRS 
            and Treasury intend to propose regulations in this area.
 Accuracy-Related Penalties on Understatements. The AJCA added 
            section 6662A to the Internal Revenue Code, which provides 
            a new penalty for understatements with respect to 
            reportable transactions. The AJCA also added section 
            6664(d) to the Code, which provides a defense to the 
            penalty under section 6662A if the taxpayer acted with 
            reasonable cause and in good faith. Additionally, the AJCA 
            amended section 6662(d) of the Code to modify the accuracy-
            related penalty for substantial understatements of income 
            tax. In January 2005, the IRS and Treasury issued Notice 
            2005-12 to provide interim guidance relating to these 
            provisions. The IRS and Treasury intend to issue 
            regulations providing further guidance relating to these 
            provisions and clarifying the relationship between the 
            penalty regulations and the standards of practice for tax 
            shelter opinions adopted in the Circular 230 regulations 
            promul gated under section 330 of title 31, United States 
            Code.
 Practice Before the Internal Revenue Service (Circular 230). 
            Section 330 of title 31, United States Code, authorizes the 
            Secretary of the Treasury to regulate the practice of 
            representatives before the Treasury Department. The 
            Secretary has published these regulations in Circular 230 
            (31 CFR Part 10). In 2001, the IRS and Treasury issued 
            proposed amendments to the regulations relating to practice 
            before the IRS, which addressed general matters and 
            proposed standards of practice for tax shelter opinions. In 
            2002, final regulations were issued incorporating only the 
            non-tax shelter matters. In 2003, amendments to the 
            standards of practice for tax shelter opinions were 
            reproposed. Those reproposed regulations set forth best 
            practices for tax advisors providing advice to taxpayers 
            relating to Federal tax issues or submissions to the IRS 
            and modified the standards for certain tax shelter 
            opinions. In 2004, final regulations addressing covered 
            opinions were issued along with proposed regulations 
            addressing state and local bond opinions. Technical 
            corrections to the tax shelter regulations were issued in 
            2005. During fiscal year 2006, the IRS and Treasury intend 
            to issue additional regulations regarding practice before 
            the IRS.
 Inclusion in Gross Income of Deferred Compensation Under 
            Nonqualified Deferred Compensation Plans. Section 409A of 
            the Internal Revenue Code was enacted by the AJCA and 
            provides that unless certain requirements are met, all 
            amounts deferred under a nonqualified deferred compensation 
            plan for all taxable years are currently includible in 
            gross income to the extent not subject to a substantial 
            risk of forfeiture and not previously included in gross 
            income, and are subject to certain additional taxes. The 
            IRS and Treasury intend to issue regulations that will 
            clarify the application of section 409A to nonqualified 
            deferred compensation plans.
Office of the Comptroller of the Currency
 The Office of the Comptroller of the Currency (OCC) charters, 
regulates, and supervises national banks to ensure a safe, sound, and 
competitive national banking system that supports the citizens, 
communities, and economy of the United States. The substantive content 
of the OCC's regulations reflects four organizing principles that 
support this mission:
 The OCC's regulations help ensure safety and soundness by 
            establishing standards that set the limits of acceptable 
            conduct for national banks.
 The OCC's regulations promote competitiveness by facilitating 
            a national bank's ability to develop new lines of business, 
            subject to any safeguards that are necessary to ensure that 
            the bank has the expertise to manage risk effectively and 
            adapt its business practices to deal responsibly with its 
            customers.
 Regulations can also affect national banks' ability to compete 
            by contributing significantly to their costs. The OCC's 
            goal is to improve efficiency and reduce burden by updating 
            and streamlining its regulations and eliminating those that 
            no longer contribute significantly to the fulfillment of 
            its mission.
 The OCC's regulations help assure fair access to financial 
            services for all Americans by removing unnecessary 
            impediments to the flow of credit to consumers and small 
            businesses, by encouraging national banks' involvement in 
            community development activities, and by implementing 
            Federal laws designed to protect consumers of financial 
            services.
 The OCC's regulatory workload and plans are affected directly by 
statute. One statute requiring regulatory action is the Economic Growth 
and Regulatory Paperwork Reduction Act of 1996 (EGRPRA). The OCC, 
together with the Board of Governors of the Federal Reserve System, 
Federal Deposit Insurance Corporation, and the Office of Thrift 
Supervision (banking agencies), is conducting a review of its 
regulations, pursuant to the EGRPRA. This process will continue through 
2006. To date, the banking agencies' review has included: (1) issuing 
five notices, published in the Federal Register, that solicit comment 
from the industries we regulate and the public on ways to reduce 
regulatory burden with respect to specific categories of regulations; 
and (2) conducting outreach meetings with bankers and consumer groups 
in cities across the country for the same purpose. The review process 
and outreach meetings have generated a number of helpful suggestions 
which we, along with the other agencies, are evaluating on an ongoing 
basis. When these processes for obtaining input are complete, the OCC 
expects to be able to

[[Page 64226]]

determine whether revisions to any of its rules are appropriate in 
order to further the purposes of the EGRPRA and reduce burden. The 
agencies will further report to Congress on their conclusions at the 
end of the process, along with any suggestions for possible legislative 
changes.
 Significant final rules issued during fiscal year 2005 include:
 Proper Disposal of Consumer Information (12 CFR 
            Parts 30 and 41). The Office of the Comptroller of the 
            Currency, Board of Governors of the Federal Reserve System, 
            Federal Deposit Insurance Corporation, and Office of Thrift 
            Supervision (banking agencies) issued a joint rule to 
            implement section 216 of the Fair and Accurate Credit 
            Transactions Act of 2003. Section 216 requires the banking 
            agencies, the National Credit Union Administration, the 
            Securities and Exchange Commission, and the Federal Trade 
            Commission to adopt consistent and comparable regulations, 
            to the extent possible, requiring entities subject to their 
            jurisdiction to properly dispose of consumer information as 
            a means to reduce the risk of identity theft. The banking 
            agencies issued a joint final rule on December 28, 2004 at 
            70 FR 77610.
 Safety and Soundness Standards; Interagency Guidance 
            on Response Programs for Unauthorized Access to Customer 
            Information and Customer Notice (12 CFR Part 30). The 
            Office of the Comptroller of the Currency, Board of 
            Governors of the Federal Reserve System, Federal Deposit 
            Insurance Corporation, Office of Thrift Supervision, and 
            National Credit Union Administration (agencies) issued an 
            interpretation of section 501(b) of the Gramm-Leach-Bliley 
            Act and the Interagency Guidelines Establishing Standards 
            for Safeguarding Customer Information. This interpretation 
            describes the agencies' expectations regarding the response 
            programs, including customer notification procedures, that 
            a financial institution should develop and implement to 
            address the unauthorized access to or use of customer 
            information that could result in substantial harm or 
            inconvenience to a customer. A final interpretation was 
            published on March 29, 2005 at 70 FR 15736.
 Fair Credit Reporting Regulations; Use of Medical 
            Information (12 CFR Part 41). The Office of the Comptroller 
            of the Currency, Board of Governors of the Federal Reserve 
            System, Federal Deposit Insurance Corporation, Office of 
            Thrift Supervision, and National Credit Union 
            Administration (agencies) issued a final rule to implement 
            section 411 of the Fair and Accurate Credit Transactions 
            Act of 2003. Section 411(a) requires the agencies to 
            prescribe regulations that permit creditors to obtain or 
            use medical information for certain credit eligibility 
            purposes. Additionally, section 411(b) authorizes the 
            agencies to issue rules to allow additional sharing of 
            information determined by the agencies to be appropriate or 
            necessary. The agencies issued an interim rule on June 10, 
            2005 at 70 FR 33958, and expect to issue a final rule in 
            the near term.
 Community Reinvestment Act Regulation (12 CFR 
            25).The Office of the Comptroller of the Currency, Board of 
            Governors of the Federal Reserve System, and Federal 
            Deposit Insurance Corporation (agencies) issued a final 
            rule to revise certain provisions of our rules implementing 
            the Community Reinvestment Act (CRA). The action was taken 
            in response to public comments we received on our February 
            2004 CRA proposal (69 FR 5729). The rule addresses 
            regulatory burden imposed on smaller national banks by 
            revising the eligibility requirements for CRA evaluation 
            under the lending, investment, and service tests. 
            Specifically, the rule provides a simplified lending test 
            and a flexible and streamlined community development test 
            for small banks with an asset size between $250 million and 
            $1 billion. Holding company affiliation is not a factor in 
            determining which CRA evaluation standards apply to a bank. 
            The OCC estimates that this rule will reduce burden and 
            costs for national banks. The agencies issued a joint final 
            rule on August 2, 2005 at 70 FR 44256.
 Electronic Filing and Disclosure of Beneficial 
            Ownership Reports (12 CFR Part 11). The Office of the 
            Comptroller of the Currency adopted a final rule based on 
            the interim rule, issued on September 22, 2003 at 68 FR 
            54981, to implement provisions enacted in the Sarbanes-
            Oxley Act of 2002 (Act). The Act made amendments to section 
            16(a) of the Securities Exchange Act of 1934, which 
            requires the filing of beneficial ownership reports by 
            officers, directors, and principal shareholders of issuers 
            of securities. The OCC administers and enforces section 
            16(a) with respect to officers, directors, and principal 
            shareholders of national banks. Effective July 30, 2003, 
            the Act required that beneficial ownership reports be filed 
            electronically and posted on the issuer's corporate 
            website, if it has a website. The interim rule requires 
            that beneficial ownership reports filed by officers, 
            directors, and principal shareholders of a national bank be 
            filed electronically pursuant to the FDIConnect system and 
            that the reports be placed on the website of the national 
            bank if it has a website. The OCC adopted a final rule on 
            August 10, 2005 at 70 FR 46403.
 The OCC's regulatory priorities for fiscal year 2006 include projects 
in the following areas:
 The OCC plans to issue rules implementing the requirements of the Fair 
and Accurate Credit Transactions Act of 2003 as follows:
 Identity Theft Detection, Prevention, and Mitigation 
            Program for Financial Institutions and Creditors (12 CFR 
            Parts 30 and 41). The Office of the Comptroller of the 
            Currency, Board of Governors of the Federal Reserve System, 
            Federal Deposit Insurance Corporation, Office of Thrift 
            Supervision, National Credit Union Administration, and 
            Federal Trade Commission (agencies) are planning to issue a 
            rule to establish guidelines and regulations to implement 
            sections 114 and 315 of the Fair and Accurate Credit 
            Transactions Act of 2003. Section 114 requires the agencies 
            to issue jointly guidelines for financial institutions and 
            creditors identifying patterns, practices, and specific 
            forms of activity that indicate the possible existence of 
            identity theft. In addition, the agencies must issue 
            regulations requiring each financial institution and 
            creditor to establish reasonable policies and procedures to 
            implement the guidelines. The regulations must contain a 
            provision requiring a card issuer to notify the cardholder 
            if the card issuer receives a notice of change of address 
            for an existing account, and a short time later receives a 
            request for an additional or replacement card. Section 315 
            requires the agencies to jointly issue regulations 
            providing guidance regarding reasonable policies and 
            procedures that a user of consumer reports should employ 
            when such user receives a notice of address discrepancy 
            from a consumer reporting agency, informing the user of a 
            substantial discrepancy between the address for the 
            consumer that the user provided to request the consumer

[[Page 64227]]

            report and the address(es) in the file for the consumer. 
            The proposed rules implementing this section require users 
            of consumer reports to validate the identity of the 
            consumer upon receipt of a notice of address discrepancy 
            and provide consumer reporting agencies with updated 
            information about a consumer's address.
 Fair Credit; Affiliate Marketing Regulations (12 CFR 
            Part 41). The Office of the Comptroller of the Currency, 
            Board of Governors of the Federal Reserve System, Federal 
            Deposit Insurance Corporation, Office of Thrift 
            Supervision, and National Credit Union Administration 
            (agencies) are planning to issue a rule to implement the 
            affiliate sharing provisions of section 214 of the Fair and 
            Accurate Credit Transactions Act of 2003 (FACT Act). The 
            rule would implement the consumer notice and opt-out 
            provisions of the FACT Act regarding the sharing of 
            consumer information among affiliates for marketing 
            purposes. The agencies issued a notice of proposed 
            rulemaking on July 15, 2004 at 69 FR 42502.
 Fair Credit Reporting, Accuracy and Integrity of 
            Information Furnished to Consumer Reporting Agencies (12 
            CFR part 41).The Office of the Comptroller of the Currency, 
            Board of Governors of the Federal Reserve System, Federal 
            Deposit Insurance Corporation, Office of Thrift 
            Supervision, National Credit Union Administration, Federal 
            Trade Commission, and Securities and Exchange Commission 
            (agencies) are planning to issue a joint rule to implement 
            section 312 of the Fair and Accurate Credit Transactions 
            Act of 2003. Section 312 requires the agencies to consult 
            and coordinate with each other in order to issue consistent 
            and comparable regulations requiring persons that furnish 
            information to a consumer reporting agency to establish 
            reasonable policies and procedures for the implementation 
            of the agencies' guidelines regarding the accuracy and 
            integrity of information relating to consumers. In 
            addition, the agencies are to jointly prescribe regulations 
            that identify the circumstances under which a furnisher of 
            information to a consumer reporting agency shall be 
            required to reinvestigate a dispute concerning the accuracy 
            of information contained in a consumer report based on the 
            consumer's direct request to the furnisher.
The OCC plans to issue other rules as follows:
 Risk-Based Capital Guidelines: Implementation of New 
            Basel Capital Accord (12 CFR Part 3). The Office of the 
            Comptroller of the Currency, Board of Governors of the 
            Federal Reserve System, Federal Deposit Insurance 
            Corporation, and Office of Thrift Supervision (banking 
            agencies) plan to issue a notice of proposed rulemaking 
            based on the International Convergence of Capital 
            Measurement and Capital Standards: A Revised Framework, the 
            new capital adequacy framework commonly known as Basel II. 
            The banking agencies published an advance notice of 
            proposed rulemaking (ANPR) on August 4, 2003 at 68 FR 45900 
            soliciting industry comments on a draft of the proposed 
            framework for implementing the New Basel Capital Accord in 
            the United States. In particular, the ANPR described 
            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 ANPR specified criteria that a banking 
            organization must meet to use the advanced approaches. 
            Under the advanced approaches, a banking organization would 
            use internal estimates of certain risk components as key 
            inputs in the determination of their regulatory capital 
            requirements. The OCC has included this rulemaking project 
            in Part II of the Regulatory Plan.
 Risk-Based Capital Guidelines; Capital Adequacy 
            Guidelines; Capital Maintenance: Domestic Capital 
            Modifications (12 CFR Part 3). The Office of the 
            Comptroller of the Currency, Board of Governors of the 
            Federal Reserve System, Federal Deposit Insurance 
            Corporation, and Office of Thrift Supervision (banking 
            agencies) plan to issue an advance notice of proposed 
            rulemaking to amend various provisions of the capital rules 
            for those banks that will not qualify to use the new Basel 
            Capital Accord (Basel II) capital framework.
 One-Year Post-Employment Restrictions for Senior 
            Examiners (12 CFR Parts 4 and 19). The Office of the 
            Comptroller of the Currency, Board of Governors of the 
            Federal Reserve System, Federal Deposit Insurance 
            Corporation, and Office of Thrift Supervision (banking 
            agencies) are issuing a joint notice of proposed rulemaking 
            to implement section 6303(b) of the Intelligence Reform and 
            Terrorism Prevention Act of 2004, which imposes a one-year 
            post-employment restriction on ``senior examiners'' of 
            depository institutions and depository institution holding 
            companies. A senior examiner employed or commissioned by an 
            agency may not knowingly accept compensation as an 
            employee, officer, director, or consultant from certain 
            depository institutions or depository institution holding 
            companies they examined, or from certain related entities, 
            for one year after the examiner leaves the employment or 
            service of the agency. Violation results in the examiner 
            being subject to an order of removal and prohibition from 
            the relevant bank and all insured depository institutions 
            for up to 5 years, a civil money penalty of up to $250,000, 
            or both. The agencies issued a proposed rule on August 5, 
            2005 at 70 FR 45323.
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, the Office of the Comptroller of the Currency, the Board of 
Governors of the Federal Reserve System, and the Federal Deposit 
Insurance Corporation (collectively, the banking agencies) continue to 
work together on regulations where the agencies share the 
responsibility to implement statutory requirements. The banking 
agencies are working to update capital standards to maintain, and, 
where necessary, improve consistency in the agencies' rules, including 
the International Convergence of Capital Management and Capital 
Standards: A Revised Framework (Basel II). The domestic implementation 
of the New Basel Capital Accord was introduced in 2003 with publication 
of an advanced notice of proposed rulemaking (ANPRM) and draft 
supervisory guidance. 68 FR 45900 (August 4, 2003). It included an 
introduction to the advanced internal ratings-based (IRB) approach to 
credit risk, and the advanced measurement approach for operational 
risk. The

[[Page 64228]]

ANPRM also specified the criteria that a banking organization must meet 
to use these advanced approaches. In addition, the banking agencies 
plan to issue an ANPR to increase the risk sensitivity of the existing 
risk-based capital framework that is currently applicable to all U.S. 
institutions.
Significant final rules issued during fiscal year 2005 include:
 Proper Disposal of Consumer Information. The banking 
            agencies issued a joint rule to implement section 216 of 
            the Fair and Accurate Credit Transactions Act of 2003. 
            Section 216 requires the banking agencies, the National 
            Credit Union Administration (NCUA), the Securities and 
            Exchange Commission (SEC), and the Federal Trade Commission 
            (FTC) to adopt consistent and comparable regulations, to 
            the extent possible, requiring entities subject to their 
            jurisdiction to properly dispose of consumer information as 
            a means to reduce the risk of identity theft. The banking 
            agencies issued a joint final rule on December 28, 2004 at 
            69 FR 77610.
 Safety and Soundness Standards: Interagency Guidance 
            on Response Programs for Unauthorized Access to Customer 
            Information and Customer Notice. The banking agencies and 
            the NCUA issued an interpretation of section 501(b) of the 
            Gramm-Leach-Bliley Act and the Interagency Guidelines 
            Establishing Standards for Safeguarding Customer 
            Information. This interpretation describes the agencies' 
            expectations regarding the response programs, including 
            customer notification procedures, that a financial 
            institution should develop and implement to address the 
            unauthorized access to or use of customer information that 
            could result in substantial harm or inconvenience to a 
            customer. The interpretation was published on March 29, 
            2005 at 70 FR 15736.
 Fair Credit Reporting Regulations (Medical 
            Information): The banking agencies and the NCUA issued an 
            interim final rule implementing section 411 of the FACT 
            Act, which amended the Fair Credit Reporting Act (FCRA) by 
            (1) prohibiting creditors from obtaining or using medical 
            information pertaining to a consumer in connection with any 
            determination of the consumer's eligibility or continued 
            eligibility for credit, and (2) creating limited exceptions 
            to permit affiliates to share medical information with each 
            other without becoming consumer reporting agencies. The 
            interim final rule was published on June 10, 2005 at 70 FR 
            33958, and the agencies expect to issue a final rule in the 
            near term.
 Moreover, as part of its review of regulations under section 2222 of 
the Economic Growth and Regulatory Paperwork Reduction Act of 1996, OTS 
plans to finalize its current interim final rule to reduce regulatory 
burden on savings associations by updating and revising various 
application and reporting requirements.
 The banking agencies also issued a joint notice of proposed rulemaking 
on August 5, 2005 at 70 FR 45323, to implement section 6303(b) of the 
Intelligence Reform and Terrorism Prevention Act of 2004, which imposes 
a one-year post-employment restriction on ``senior examiners'' of 
depository institutions and depository institution holding companies. A 
senior examiner employed or commissioned by an agency may not knowingly 
accept compensation as an employee, officer, director, or consultant 
from certain depository institutions or depository institution holding 
companies they examined, or from certain related entities, for one year 
after the examiner leaves the employment or service of the agency.
 OTS anticipates implementing sections of the Fair and Accurate Credit 
Transactions Act of 2003 (FACT Act) as follows:
 Fair Credit Reporting Affiliate Marketing 
            Regulations. The banking agencies and the NCUA also plan to 
            issue a final rule implementing section 214 of the FACT 
            Act, which amended the FCRA. The rule would implement the 
            consumer notice and opt-out provisions of the Fact Act 
            regarding the sharing of consumer information among 
            affiliates for marketing purposes. The agencies published a 
            proposed rule on July 15, 2004, at 69 FR 42502.
 Fair Credit Reporting, Accuracy & Integrity of 
            Information Furnished to Consumer Reporting Agencies. The 
            banking agencies and the NCUA, SEC, and FTC are planning to 
            issue a joint rule to implement section 312 of the FACT 
            Act. Section 312 requires the agencies to consult and 
            coordinate with each other in order to issue consistent and 
            comparable regulations requiring persons that furnish 
            information to a consumer reporting agency to establish 
            reasonable policies and procedures for the implementation 
            of the agencies' guidelines regarding the accuracy and 
            integrity of information relating to consumers. In 
            addition, the agencies are to jointly prescribe regulations 
            that identify the circumstances under which a furnisher of 
            information to a consumer reporting agency shall be 
            required to reinvestigate a dispute concerning the accuracy 
            of information contained in a consumer report based on the 
            consumer's direct request to the furnisher.
 Identity Theft Detection, Prevention, and Mitigation 
            Program for Financial Institutions and Creditors. The 
            banking agencies, the NCUA, and the FTC also plan to issue 
            a proposed rule implementing section 114 and 315 of the 
            FACT Act, which requires the agencies to develop guidelines 
            for use in identifying patterns, pract ices, and specific 
            forms of activity that indicate the possible existence of 
            identity theft. The agencies are also required to issue 
            regulations requiring each financial institution and 
            creditor to establish reasonable policies and procedures to 
            implement such guidelines. The regulations must contain a 
            provision requiring a card issuer to notify the cardholder 
            if the card issuer receives a notice of change of address 
            for an existing account, and a short time later receives a 
            request for an additional or replacement card. Section 315 
            requires the agencies to jointly issue regulations 
            providing guidance regarding reasonable policies and 
            procedures that a user of consumer reports should employ 
            when such user receives a notice of address discrepancy 
            from a consumer reporting agency, informing the user of a 
            substantial discrepancy between the address for the 
            consumer that the user provided to request the consumer 
            report and the address(es) in the file for the consumer.
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:
 Regulate the alcohol and tobacco industries, including systems 
            for licenses and permits;
 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;

[[Page 64229]]

 Suppress commercial bribery, consumer deception, and other 
            prohibited practices in the alcoholic beverage industry; 
            and
 Assist the States and other Federal agencies in their efforts 
            to eliminate interstate trafficking in, and the sale and 
            distribution of, cigarettes in avoidance of State taxes.
 In 2006, TTB will continue to pursue its multi-year program of 
modernizing its regulations in title 27 of the Code of Federal 
Regulations. This program involves updating and revising the 
regulations to be more clear, current, and concise, with an emphasis on 
the application of plain language principles. TTB laid the groundwork 
for this program in 2002 when it started to recodify its regulations in 
order to present them in a more logical sequence. In FY 2005, TTB 
evaluated all of the 36 CFR parts in title 27 and prioritized them as 
``high,'' ``medium,'' or ``low'' in terms of the need for complete 
revision or regulation modernization. We determined importance based on 
industry member numbers, revenue collected, enforcement and compliance 
issues identified through field audit and permit qualification, 
statutory changes, significant industry innovation, and other factors. 
The ten CFR parts that TTB ranked as ``high'' include the five parts 
directing operation of the major taxpayers under the Internal Revenue 
Code of 1986: Part 19 - Distilled Spirits Plants; Part 24 - Wine; Part 
25 - Beer; Part 40 - Manufacture of Tobacco Products and Cigarette 
Papers and Tubes; and Part 53 - Manufacturers Excise Taxes - Firearms 
and Ammunition. These five CFR parts represent nearly all the tax 
revenue that TTB collects, or $14.6 billion in FY 2004. Work has begun 
on parts 19 and 25. The remaining five parts rated ``high'' consist of 
regulations covering imports and exports (Part 27 - Importation of 
Distilled Spirits, Wine and Beer; Part 28 - Exportation of Alcohol; and 
Part 41 - Exportation of Tobacco Products and Cigarette Papers and 
Tubes), the American Viticultural Area program (Part 9), and TTB 
procedures (Part 70). In FY 2006, proposed rules will be published on 
parts 19 and 28, and an advance notice of proposed rulemaking will be 
published on Part 25.
 In addition to our modernization updates, in FY 2006 TTB will address 
alcohol beverage allergen and other labeling issues in regulations, 
with proposed rules targeted to be published the end of the fiscal 
year.
Bureau of the Public Debt
 The Bureau of the Public Debt (BPD) administers the following 
regulations:
 Governing transactions in Government securities by Government 
            securities brokers and dealers under the Government 
            Securities Act of 1986 (GSA), as amended.
 Implementing Treasury's borrowing authority, including rules 
            governing the sale and issue of savings bonds, marketable 
            Treasury securities, and State and local Government 
            securities.
 Setting out the terms and conditions by which Treasury may 
            redeem (buy back) outstanding, unmatured marketable 
            Treasury securities through debt buyback operations.
 Governing the acceptability and valuation of all collateral 
            pledged to secure deposits of public monies and other 
            financial interests of the Federal Government.
 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.
 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 2006, BPD will accord 
priority to the implementation of a paperless process for Treasury 
auctions. A streamlined electronic form will replace the paper 
agreement for electronic access now in use; certain provisions from the 
paper agreement would be incorporated into the Uniform Offering 
Circular.
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 government-wide accounting 
programs.
 During fiscal year 2006, FMS's regulatory priorities include the 
following:
 Foreign Exchange Operations (31 CFR Part 281): FMS 
            plans to issue a notice of proposed rulemaking to amend 31 
            CFR Part 281 to establish currency conversion fees for 
            electronic Federal payments disbursed to overseas 
            recipients. To deliver a payment to a bank account 
            maintained by an individual or business in a foreign 
            country, it is necessary first to convert the payment from 
            U.S. dollars to the local currency. FMS does not generally 
            provide currency conversion services when disbursing 
            payments, such as when Treasury checks are mailed abroad, 
            and is proposing to recoup the cost of this special service 
            from payment recipients pursuant to the authority of 31 
            U.S.C. 9701. We anticipate publication of the notice in the 
            fall of 2005, with a 60 day comment period.
 Management of Federal Agency Disbursements and 
            Automated Clearing House (ACH) (31 CFR Parts 208 and 210): 
            FMS plans to issue a notice of proposed rulemaking to amend 
            31 CFR Parts 208 and 210 to allow Federal agencies to issue 
            part or all of an employee's travel reimbursement to the 
            travel card issuing bank for crediting to the employee's 
            travel card account (``split disbursement''). Presently, 31 
            CFR 208.6 and 210.5 require that Federal electronic 
            payments other than vendor payments be directed to a 
            deposit account at the financial institution in the name of 
            the individual. Federal employee travel accounts are not 
            deposit accounts and therefore do not meet this 
            requirement. Because of the benefits of split disbursement, 
            a waiver was issued on April 25, 2005 to allow split 
            disbursement of Federal employee travel card 
            reimbursements, in accordance with the Secretary's waiver 
            authority set forth at 31 CFR 208.6 and 210.5. FMS proposes 
            to codify this waiver by creating an exception to the 
            requirements of 31 CFR 208.6 and 210.5. We anticipate 
            publication of the notice in the fall of 2005, with a 60 
            day comment period.
_______________________________________________________________________



TREAS--Comptroller of the Currency (OCC)

                              -----------

                          PROPOSED RULE STAGE

                              -----------




98. IMPLEMENTATION OF A REVISED BASEL CAPITAL ACCORD (BASEL II)

Priority:


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


Legal Authority:


12 USC 93a; 12 USC 3907


CFR Citation:


12 CFR 3

[[Page 64230]]

Legal Deadline:


None


Abstract:


As part of OCC's ongoing efforts to develop and refine capital 
standards to ensure the safety and soundness of the national banking 
system and to implement statutory requirements, OCC is amending various 
provisions of the capital rules for national banks. This change 
involves the implementation of the new Basel Capital Accord (Basel II). 
OCC is conducting this rulemaking jointly with the other Federal 
banking agencies.


Statement of Need:


This rulemaking is necessary to implement an international initiative 
regarding the capital adequacy regulation of certain domestic financial 
institutions. Specifically, this rulemaking implements the 
``International Convergence of Capital Measurement and Capital 
Standards'' (Basel II), which comprehensively revises the 1988 
``International Convergence of Capital Measurement and Capital 
Standards.'' This rulemaking will translate the lengthy and complicated 
text of Basel II into the standards and requirements that will govern 
the largest banks in the United States.


Summary of Legal Basis:


OCC is implementing the Basel II capital framework for certain domestic 
financial institutions. This initiative is based on the OCC's general 
rulemaking authority in 12 U.S.C. 93a and its specific authority under 
12 U.S.C. 3907. 12 U.S.C. 3907(a)(2) specifically authorizes OCC to 
establish minimum capital levels for financial institutions that OCC, 
in its discretion, deems necessary or appropriate.


Alternatives:


Not yet determined.


Anticipated Cost and Benefits:


Not yet determined.


Risks:


Not yet determined.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           08/04/03                    68 FR 45900
NPRM                            02/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Ron Shimabukuro
Special Counsel
Department of the Treasury
Comptroller of the Currency
Legislative and Regulatory Activities Division
250 E Street SW.
Washington, DC 20219
Phone: 202 874-5090
Fax: 202 874-4889
Email: [email protected]
Related RIN: Split from 1557-AB14
RIN: 1557-AC91
BILLING CODE 4811-37-S

[[Page 64231]]




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 38 
CFR Part 3. 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' 2005 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 was published as an interim final rule on January 17, 2003. It 
amends the Department's medical regulations to protect the quality and 
improve the timeliness of care provided to all veterans by restricting 
new enrollments in higher enrollment-priority categories.
_______________________________________________________________________



VA

                              -----------

                            FINAL RULE STAGE

                              -----------




99. 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:


The Department of Veterans Affairs (VA) published in the Federal 
Register on January 17, 2003, an interim final rule amending VA's 
medical regulations at 38 CFR part 17 to establish additional 
subpriorities within enrollment priority categories 7 and 8 and to 
provide that, beginning January 17, 2003, VA will continue to treat all 
veterans currently enrolled in any category, and will treat new 
enrollees in categories 1 through 7. However, the interim final rule 
provided that VA will suspend the enrollment of additional veterans who 
are in the lowest statutory enrollment category (priority category 8). 
Based on the rationale set forth in the interim final rule, VA is 
adopting the provisions of the interim final rule as a final rule 
without change.


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                            Date                        FR Cite

_______________________________________________________________________
Interim Final Rule              01/17/03                     68 FR 2670
Interim Final Rule 
    Effective                   01/17/03
Interim Final Rule 
    Comment Period End          03/18/03
Final Action                    12/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 64232]]

URL For Public Comments:
www.regulations.gov

Agency Contact:
William Tilton
Program Analyst
Department of Veterans Affairs
810 Vermont Avenue NW
Washington, DC 20420
Phone: 202 273-6270
RIN: 2900-AL51
BILLING CODE 8320-01-S

[[Page 64233]]




ENVIRONMENTAL PROTECTION AGENCY (EPA)



Statement of Priorities
OVERVIEW
The U.S. Environmental Protection Agency (EPA) is the leading Federal 
agency responsible for protecting human health and the environment. 
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 chemicals and pesticides. It is EPA's goal to continue to 
accelerate environmental progress and to deliver better, more efficient 
results while maintaining our Economic Competitiveness.
To continue to build on its success, EPA is focusing on five primary 
principles. These principles are:
 Focusing on results;
 Committing to sound science;
 Understanding the importance of communication;
 Advancing innovation and collaboration; and,
 Investing in human capital.
EPA's first principle relates to its commitment to provide the American 
people with results. To do this, EPA must operate efficiently, 
effectively and competitively today -- as well as building the 
necessary framework for tomorrow. The President's Management Agenda 
demands a focus on environmental results that are effective and 
enduring. By focusing on results, our nation's environment has made 
extraordinary gains. In the last four years alone, under the Bush 
Administration:
 Airborne pollutants have declined by 10 percent;
 1200 industrial sites have been restored to productive use 
            through the Brownfields program;
 From 2002 to 2003, toxic chemicals released into the 
            environment have declined by 6 percent;
 And in 2004 alone, 800,000 acres of wetlands were restored or 
            enhanced.
In order to achieve results, EPA works to make sure every Agency 
decision is based on sound science -- the same sound science that is 
the basis of all its achievements and the genesis for future successes. 
Continuous investment in sound science is our second principle. In 
order to make a good, effective decision, one must consider and 
understand the full range of possibilities -- including all of the 
strengths and weaknesses of an option -- before reaching a conclusion. 
That's part of the sound science of a decision.
By expanding E-Government, the Administration and EPA is ensuring that 
the federal government is improving its ability to serve its citizens. 
Our third principle is to advance the credibility of EPA's decisions by 
highlighting the sound science on which all of our actions are based, 
and by effectively communicating to the public how and why our 
conclusions are reached. It is a challenge for anyone practicing good 
government to effectively relay your message, while still staying true 
to your founding values -- in EPA's case, the value of sound science.
EPA has been at the forefront of advancing innovation and has also been 
a leader in collaborative problem solving -- its fourth principle. 
Collaborative efforts, innovative programs, education and outreach are 
the proven tools for today and tomorrow. Over the Agency's 35 years, 
public perception of environmental stewardship has evolved from ``let 
the government take care of it,'' into an understanding that protecting 
our shared environment is each individual's responsibility. By 
promoting a culture of partnerships over conflicts, EPA is helping to 
usher in a new era of environmental protection. By involving more 
participants in the process, we promote a culture of environmental 
stewardship -- both in this country and in others throughout the world.
None of these goals will be achieved without the help of EPA's 
dedicated staff. That is why EPA's fifth principle is an investment in 
human capital. The success of EPA and the health of our nation's 
environment is inseparable from the productivity and creativity of the 
Agency's professional staff. President Bush is the only president, at 
least in modern times, that has as a priority the development of 
comprehensive strategy for investing in human capital.
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.
EPA continues to focus on implementing its Small Business Strategy. By 
better coordinating small business activities, EPA aims to improve its 
technical assistance and outreach efforts, minimize burdens 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 (and for a 
more extensive list of rules affecting small businesses, please see 
appendices B and C to the Regulatory Agenda which is available at 
epa.gov/regagenda.)
Rules Expected to Have a Significant Impact on a Substantial Number of 
Small Entities
Control of Hazardous Air Pollutants From Mobile Sources (2060-AK70)
Control of Emissions from New Locomotives and New Marine Diesel Engines 
less than 30 liters per Cylinder (2060-AM06)
Control of Emissions from Spark-Ignition Engines and Fuel Systems from 
Marine Vessels and Small Equipment (2060-AM34)
National Primary Drinking Water Regulations: Revisions to the Total 
Coliform Monitoring and Analytical Requirements and Additional 
Distribution System Requirements (2040-AD94)
National Primary Drinking Water Regulations: Radon (2040-AA94)
National Primary Drinking Water Regulations: Ground Water Rule (2040-
AA97)
Lead-Based Paint Activities; Amendments for Renovation, Repair and 
Painting (2070-AC83)
Rule on Section 126 Petition from NC to Reduce Interstate Transport of 
Fine PM and O3;FIPs to Reduce Interstate Transport of Fine PM & 
O3;Revisions to the CAIR Rule; Revisions to the Acid Rain Program 
(2060-AM99)
Federal Implementation Plans to Reduce Interstate Transport of Fine 
Particulate Matter and Ozone (2060-AM93)
Highlights Of EPA's Regulatory Plan
Office of Air and Radiation
A principal regulatory priority of EPA's Office of Air and Radiation 
(OAR) in 2006 is to protect public health and the environment from the 
harmful

[[Page 64234]]

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. These pollutants 
also degrade visibility in national parks and other scenic areas. OAR 
is also working to increase the effectiveness and efficiency of its 
permitting and monitoring programs, which are among the main mechanisms 
through which clean-air protections are implemented. Finally, OAR is 
revising previously-issued safety standards for nuclear-waste storage 
in response to a court decision. These efforts are described briefly 
below.
One of OAR's principal vehicles to mitigate particulate and ozone 
pollution is the program to reduce the long-range transport of the 
``precursor'' pollutants that drift downwind and form particulates and 
ozone. The centerpiece of this program is the Clean Air Interstate Rule 
(CAIR), promulgated in May of 2005, which will achieve large reductions 
in sulfur dioxide and nitrogen oxide emissions that cause particulate 
and ozone pollution in the eastern half of the nation. This program 
will achieve its reductions via State-managed emissions-reduction 
programs in each of the 28 States covered by CAIR. In 2006, OAR will 
develop two additional rules that complement CAIR. The first of these 
is a Federal Implementation Plan (FIP) that will provide a backstop for 
CAIR in cases where the States fail to act. The second additional rule 
will add Delaware and New Jersey to the group of States covered by 
CAIR. OAR is also developing a related program to enhance scenic areas 
by reducing the particulate pollution that causes ``regional haze,'' 
restricting visibility in those areas. In 2006, this program will 
include a rule that will refine the definition of ``Best Available 
Control Techology'' (BART) for achieving pollution reductions under the 
program.
To complement these CAIR-related rules and help control ozone and 
particulate pollution, OAR is developing two additional rulemakings as 
part of its program to reduce emissions from mobile sources. These 
rules will require additional emission reductions from certain marine 
vessels, locomotives, and small equipment and will add requirements for 
fuel economy labeling and ethanol content in gasoline. These rules will 
enhance the overall mobile-source control program that has already set 
stringent standards for most categories of vehicles, engines, and their 
fuels.
Even though these Federal rules will go a long way toward reducing the 
ozone and particulate pollution in America's cities, they can't do the 
job alone. Additional State and local control programs under the Clean 
Air Act will need to be instituted or enhanced in many of the most 
polluted areas. To help and guide the States and local governments in 
these efforts, EPA is developing implementation rulemakings for both 
ozone and particulates that will provide technical help and policy 
guidance crucial to assuring that State and local efforts achieve their 
pollution-control goals.
OAR also continues to assess new scientific information that underlies 
the National Ambient Air Quality Standards (NAAQS), which are the 
centerpiece of the Clean Air Act and the foundation of OAR's program. 
In late 2005, EPA expects to propose a rule that will announce the 
results of the latest review of the particulate matter NAAQS in the 
form of a proposed rule to either revise or reaffirm the current 
standard. This rule will be finalized in 2006. A companion rule on 
ozone will follow in 2007.
EPA continues to address toxic air pollution under authority of the 
Clean Air Act Amendments of 1990. The largest part of the current 
effort is the ``Residual Risk'' program, which is the second phase of 
the regulatory program for major stationary sources of toxic air 
pollution and consists of evaluating the effectiveness of technology-
based standards (which were developed in the first phase of the 
program) in reducing health risks and assessing the need for 
additional, more stringent standards to further reduce health risks. In 
2006, we will propose to create a process by which facilities can 
comply with residual risk standards by demonstrating that they already 
pose low risks. Also in 2006, we will propose to require additional 
reductions in toxic emissions from mobile sources such as cars and 
trucks.
Since many air quality programs are administered through permitting and 
monitoring programs, OAR continues to work toward improving these 
programs to increase efficiency and reduce regulatory burden. 
Currently, OAR is continuing to develop rulemakings to streamline and 
improve its New Source Review (NSR) permitting program. This effort 
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. In developing these NSR rule revisions, 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. OAR is also developing a rulemaking to clarify 
and better define the kinds of monitoring required in Federal and State 
operating permit programs.
In 2006, EPA also expects to complete a rulemaking amending the 
radiation standards governing the development of the Yucca Mountain 
site in Nevada, the nation's designated geologic repository for spent 
nuclear fuel and high-level radioactive waste. These standards were 
initially issued in 2001 and were partially remanded by a Federal court 
in 2004. To address the remand, EPA must reassess the time frame for 
compliance in light of the National Academy's recommendation that 
compliance must be addressed at the time of peak dose, which may be as 
long as several hundred thousand years into the future.
In March 2005, OMB issued a report entitled ``Regulatory Reform of the 
U.S. Manufacturing Sector.'' This report describes specific actions 
Federal agencies are taking to reform regulations nominated by the 
public. This report also includes regulatory actions that will be taken 
by OAR.
Office of Environmental Information
A key regulatory priority that OEI is undertaking is the enactment of 
burden reduction for the Toxics Release Inventory (TRI) reporting 
community. The TRI program collects chemical release and other waste 
management data on over 650 chemicals from over 24,000 facilities 
across the U.S. each year. To provide TRI reporters with appropriate 
burden relief, TRI has proposed two rulemakings to address both short-
term and longer-term reporting requirement modifications while 
maintaining the practical utility of the TRI data. Specifically, OEI 
proposed the TRI Reporting Forms Modification Rule to address 
noncontroversial modifications to the TRI reporting requirements (i.e., 
Form R). The final rule was published in the Federal Register on July 
12, 2005 (70 FR 39931). OEI published a second

[[Page 64235]]

regulatory proposal examining more significant reporting modifications 
with greater potential impact on reporting burden in September.
OEI is continuing to assess burden reduction options that are 
technically, practically and legally feasible in order to meet the 
goals and statutory obligations set forth for TRI reporting. Although 
the primary goal of the effort is to reduce burden associated with TRI 
reporting, it will also maintain EPA's commitment to providing valuable 
information to the public.
In addition, EPA is committed to providing electronic means to its 
stakeholders to meet EPA's reporting requirements, specifically through 
the Central Data Exchange (CDX) system. CDX is an integrated system 
that provides electronic reporting services to more than 30,000 users 
for 16 data flows in six major EPA media programs, and is on track to 
provide electronic reporting services for all significant environmental 
data collections over the next two years. CDX enables EPA and 
participating program offices to work with stakeholders including 
State, tribal and local governments and regulated industriesto enable 
streamlined, electronic submission of data via the Internet.
By enabling the regulated community to utilize CDX as a reporting tool, 
the TRI Program has seen a 43% increase in the number of reports 
submitted to EPA via CDX for TRI Reporting Year 2004 when compared to 
Reporting Year 2003. To take advantage of CDX's paperless reporting 
feature, TRI reporters must use the EPA-provided TRI Made-Easy (TRI-ME) 
Software. For Reporting Year 2004, 95 percent of all facilities used 
TRI-ME to prepare their reports. This upward trend toward greater 
Internet reporting via CDX is great news for the TRI program. Money 
saved from processing more-costly hard-copy paper submissions to TRI 
can now be reinvested in helpful tools and automated data quality 
checks to assist facilities and in ways to provide greater electronic 
means of accessing TRI data.
CDX also promulgated a number of new data flows, including the Office 
of Water's Stormwater Electronic Notice of Intent (an electronic permit 
application), the Office of Solid Waste and Emergency Response's Risk 
Management Plan WebRC (electronic updates of emergency contact 
information), and the Office of Prevention, Pesticides, and Toxic 
Substances' Lead Request for Certification (payment transactions 
online).
CDX is EPA's point of presence on the Environmental Exchange Network, 
known as the ``Node.'' Using CDX, EPA has worked with States to provide 
the technical specifications and exchange protocols for the Network. 
CDX provides support services, including node building, security and 
authentication and help desk. OEI is working with the major programs to 
deploy their data flows as node exchanges, using XML and web services. 
These efforts are some examples of EPA's commitment to the collection 
and dissemination of the highest quality of environmental information.
Office of Prevention, Pesticides, and Toxic Substances
EPA's Office of Prevention, Pesticides, and Toxic Substances (OPPTS) 
plays an important role in protecting public health and the environment 
from potential risk from pesticides and chemicals. In addition to the 
daily activities related to our licensing programs and non-rulemaking 
activities, OPPTS has identified several regulatory priorities for the 
coming fiscal year.
In 2006, OPPTS will begin implementing a new program, mandated by 
section 3(g) of the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA), to review the registrations of all pesticides at least once 
each 15 years. The registration review program will replace the 
tolerance reassessment program (ending in 2006) and reregistration 
program that will end in 2008. Registration review will become the 
Agency's program to evaluate and manage the risks posed by existing 
pesticides. FIFRA section 3(g) requires the Agency to establish 
procedural regulations for this registration review program. A proposed 
rule was published in July 2005, and a final rule is planned for the 
fourth quarter of 2006. Promulgation of a procedural regulation is a 
high priority and necessary in order to achieve a smooth transition 
into the new registration review program.
In 2005, OPPTS issued the first in a series of proposals to update and 
revise the regulations that provide the data requirements for the 
registration of pesticide products. The 2005 proposal addressed data 
requirements for conventional chemical pesticides. Subsequent proposals 
are planned for antimicrobial, biochemical, microbial pesticides, and 
plant-incorporated protectants. The data that is required for pesticide 
registrations forms the basis for the Agency's pesticide risk 
assessment and licensing decisions. Although the Agency has kept pace 
with evolving scientific understanding of pesticide risks by requiring 
the submission of the data needed on a case-by-case basis, the 1984 
regulations have not been updated to reflect these data needs.
EPA regulations under section 18 of FIFRA 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. By early 2006, EPA expects to 
finalize a 2004 proposal that will revise the regulations to improve 
the pesticide emergency exemption process. 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. The proposed revisions would 
streamline the application and review process, thereby reducing the 
burden to applicants and EPA, while allowing for quicker emergency 
response without compromising existing protections for human health and 
the environment.
OPPTS will propose changes to the Federal regulations for the certified 
pesticide applicator program (CPAP). Many changes in State programs 
have occurred since the CPAP regulations were promulgated in the 1970s, 
such that state programs go beyond the current Federal regulations in 
training and certifying pesticide applicators. The Agency anticipates 
revisions that will broaden the scope of the certification program to 
include additional occupational users. The Agency expects these changes 
will strengthen the regulations to better protect pesticide applicators 
and the public.
EPA has issued a proposed rule to categorically ban intentional dosing 
human testing for pesticides when the subjects are pregnant women or 
children, to formalize and further strengthen existing protections for 
subjects in human research conducted or supported by EPA, and to extend 
new protections to adult subjects in intentional dosing human studies 
for pesticides conducted by others who intend to submit the research to 
EPA. This proposal, the first of several possible Agency actions, 
focuses on third-party intentional dosing human studies for pesticides 
in response to the specific requirements of EPA's FY2006 Appropriations 
Act, but invites public comment on alternative approaches with broader 
scope. This rule is being promulgated on an accelerated schedule

[[Page 64236]]

because EPA is required by the FY 2006 Appropriations Act, signed by 
the President on August 2, 2005, to promulgate a final rule within 180 
days of enactment, or by January 29, 2006.
The Agency launched the HPV Initiative in April 1998 to collect or, 
where necessary, develop basic screening level hazard data necessary to 
provide critical information about the environmental fate and potential 
hazards associated with high production volume (HPV) chemicals, 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). 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. The HPV Initiative includes a voluntary component, the HPV 
Challenge Program, and rulemaking under TSCA. Under the voluntary HPV 
Challenge Program component, to date, 368 individual companies, 104 
consortia and the International Council of Chemical Associations (ICCA) 
have committed to sponsoring 2,244 of the estimated 2,800 HPV chemicals 
included in the HPV initiative. In early 2006, OPPTS expects to issue a 
final rulemaking under TSCA that will require testing for a number 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 approximately 310,000 young children estimated to have 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 TSCA 
directs EPA to address renovation and remodeling activities and to 
revise the lead-based paint activities regulations to include 
renovation or remodeling activities that create lead-based paint 
hazards. To address these directives, the Agency is developing a 
comprehensive program for the management of renovation, repair and 
painting activities involving lead based paint hazards. The program 
will be comprised of a combination of approaches including an extensive 
education and outreach campaign for lead-safe work practices and 
training for industry, an outreach campaign designed to expand consumer 
awareness and create demand for the use of lead-safe work practices and 
the proposal of regulatory requirements. Specifically, the Agency will 
be proposing regulatory requirements for renovation, repair and 
painting contractors involved in activities where, as a result of their 
work, lead hazards are created.
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. OPPTS 
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 regulatory framework for 
procedures and processes to use when implementing the EDSP, and will 
develop an initial list of chemicals for which testing will be 
required. In late 2006, EPA anticipates publishing the draft procedures 
and processes for use in implementing the screening and testing phase 
of the EDSP.
As part of OMB's Regulatory Reform of the U.S. Manufacturing Sector 
(2005) report, commenters expressed concern that the existing TSCA 
section 12(b) regulations do not provide a low-level cut-off for the 
export notification requirements. In response to that comment, EPA 
committed to OMB that it would consider potential changes to the TSCA 
Sec. 12(b) regulation within the scope of existing statutory authority 
and issue a proposed amendment to address the concern expressed by 
January 2006. Legislation is currently still pending to address the 
implementation in the U.S. of the Rotterdam Convention on Prior 
Informed Consent (PIC), which includes export notification 
requirements.
In response to other commenters to the OMB 2005 Report, EPA has worked 
with stakeholders to address the commenters' request that EPA clarify 
the disposal requirements for small PCB remediation waste containing 
small amounts of PCBs and clarify that risk-based screening criteria 
can be used to determine the clean-up standards for a specific site. 
EPA submitted a plan to OMB in September 2005 that describes the steps 
it will take in FY2006 to address the requested clarifications.
EPA also agreed to conduct preliminary analysis of the use of mercury-
containing switches in convenience lights and braking systems installed 
in new cars and identify viable non-mercury alternatives for use in 
TSCA rulemaking and voluntary activities. EPA is committed to making a 
determination on appropriate regulatory and/or voluntary approaches for 
addressing mercury switches and other parts in automobiles by the Fall/
Winter 2005. As a result of the analysis mentioned above, EPA has made 
a determination to propose a TSCA Section 5 Significant New Use Rule 
(SNUR) in FY2006, for certain discontinued uses of mercury switches in 
automobiles.
Office of Solid Waste and Emergency Response
The Office of Solid Waste and Emergency Response has a number of high 
priority regulatory initiatives. Two consistent themes can be found in 
these initiatives: Integrating a culture of innovations in all our 
rulemakings and reducing burden on the regulated community to focus 
resources on environmental results. Both of these themes directly 
support the Administrator's goals for land preservation and restoration 
and the use of innovative methods to promote environmental stewardship.
To promote innovation through rulemaking, EPA is considering expanding 
the comparable fuels program. This program allows specific industrial 
wastes to be excluded from the Resource Conservation and Recovery Act 
(RCRA) when they are used for energy production and do not contain 
hazardous constituent levels exceeding those in a typical benchmark 
fuel that facilities would otherwise use. If EPA is successful in 
finding other industrial wastes that could be used for energy, this 
would not only save energy by reducing the amount of hazardous waste 
that would be otherwise treated

[[Page 64237]]

and disposed, but also promote energy production from a domestic, 
renewable source and reduce our use of fossil fuels. EPA is also 
examining the effectiveness of the current comparable fuel program.
EPA is seeking to revise the definition of solid waste in another 
innovation effort. For instance, EPA is looking at how to identify 
materials remaining in use in a continuous process in the generating 
industry so that they are not solid waste. The Agency is also 
considering other approaches that will increase the safe recycling of 
hazardous waste.
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. The 
regulatory changes being developed will have minimal impact on the many 
protections that EPA has established over the years for human health 
and the environment.
EPA is also considering a means to address the frequency and level of 
reporting nitrogen oxides under the Comprehensive Environmental 
Response, Compensation and Liability Act and the Emergency Planning and 
Community Right-to-Know Act. The Agency is considering reducing burden 
by either (1) using more efficiently the continuous release reporting 
mechanism or (2) granting an administrative reporting exemption for 
certain releases of nitrogen oxides.
EPA plans to issue new guidance and propose a rule concerning the Spill 
Prevention, Control, and Countermeasure(SPCC) Plan requirements. The 
guidance document will provide clarification and compliance assistance 
to facilities subject to SPCC. The rule will propose compliance 
flexibility for facilities that store small amounts of petroleum, while 
continuing to prevent potential discharges to navigable waters of the 
United States or adjoining shorelines.
All these rulemaking efforts support reform nominations mentioned in 
OMB's 2004 Report to Congress on the Costs and Benefits of Regulations. 
In addition, the rule seeking burden reduction of duplicative and non-
essential paperwork burden under RCRA was also mentioned in the 2002 
Report to Congress.
Office of Water
EPA's Office of Water's primary goals are to ensure that drinking water 
is safe; restore and maintain oceans, watersheds, and their aquatic 
ecosystems to protect human health; support economic and recreational 
activities; and provide healthy habitat for fish, plants, and wildlife. 
In order to meet these goals, EPA has established a number of 
regulatory priorities for the coming year. They include rules affecting 
cooling water intakes and drinking water.
On November 1, 2004, EPA proposed rules to control 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 production equipment. As required 
by the Clean Water Act, 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. The proposed rule sets standards to protect fish, 
shellfish and other forms of aquatic life and provides flexibility by 
offering several alternatives for facilities to comply. This is the 
third in a series of rules designed to reduce harm to aquatic life that 
is taken up with cooling water. This phase of rulemaking may affect 
certain existing manufacturing facilities and new offshore and coastal 
oil and gas extraction facilities that use cooling water intake 
structures, and whose intake flow levels exceed one of the three 
proposed minimum thresholds. EPA sought public comment on this proposal 
for 120 days. EPA intends to take final action on June 1, 2006.
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 Ground Water Rule, a rule that addresses fecal contamination in 
public water systems served by ground water 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.
_______________________________________________________________________



EPA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




100. REVIEW OF THE NATIONAL AMBIENT AIR QUALITY STANDARDS FOR 
PARTICULATE MATTER

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 7408; 42 USC 7409


CFR Citation:


40 CFR 50


Legal Deadline:


NPRM, Judicial, December 20, 2005.


Final, Judicial, September 27, 2006.


Abstract:


On July 18, 1997, the EPA published a final rule revising the National 
Ambient Air Quality Standards (NAAQS) for particulate matter (PM) (62 
FR 38652). While retaining the PM10 standard levels, new standards were 
added for fine particles (PM2.5) to provide increased protection 
against both health and environmental effects of PM. On the same day, a 
Presidential Memorandum (62 FR 38421) was published that, among other 
things, anticipated that EPA would complete the next review of the PM 
NAAQS by July 2002. The EPA's plans and schedule for the next periodic 
review of the PM NAAQS were published on October 23, 1997 (62 FR 
55201). Due to the unprecedented volume of new research, the completion 
of the Criteria Document has been extended. As a result, the overall 
schedule for the review of the PM NAAQS has extended beyond the 
original target of July 2002. As with other NAAQS reviews, a rigorous 
assessment of relevant scientific information will be presented in a 
Criteria Document (CD) prepared by EPA's National Center for 
Environmental Assessment. The EPA's Office of Air Quality Planning and 
Standards will then prepare a Staff Paper (SP) for the Administrator 
which

[[Page 64238]]

will evaluate the policy implications of the key studies and scientific 
information contained in the CD and additional technical analyses and 
identify critical elements that EPA staff believe should be considered 
in reviewing the standards. The CD and SP will be reviewed by the Clean 
Air Scientific Advisory Committee (CASAC) and the public, and both 
final documents will reflect the input received through these reviews. 
As the PM NAAQS review is completed, the Administrator's proposal to 
revise or reaffirm the PM NAAQS will be published with a request for 
public comment. Input received during the public comment period will be 
considered in the Administrator's final decision.


Statement of Need:


As established in the Clean Air Act, the national ambient air quality 
standards for particulate matter are to be reviewed every five years.


Summary of Legal Basis:


Section 109 of the Clean Air Act (42 USC 7409) directs the 
Administrator to propose and promulgate ``primary'' and ``secondary'' 
national ambient air quality standards for pollutants identified under 
section 108 (the ``criteria'' pollutants). The ``primary'' standards 
are established for the protection of public health, while 
``secondary'' standards are to protect against public welfare or 
ecosystem effects.


Alternatives:


The main alternatives for the Administrator's decision on the review of 
the national ambient air quality standards for particulate matter are 
whether to reaffirm or revise the existing standards.


Anticipated Cost and Benefits:


Costs and benefits of revising or reaffirming the national ambient air 
quality standards for particulate matter cannot be determined at 
present; a regulatory impact analysis will be conducted along with the 
review of the standards.


Risks:


The current national ambient air quality standards for particulate 
matter are intended to protect against public health risks associated 
with morbidity or premature mortality from cardiopulmonary disease. 
During the course of this next review, a risk assessment will be 
conducted to evaluate health risks associated with retention or 
revision of the particulate matter standards.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            01/00/06
Final Action                    10/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Additional Information:


SAN No. 4255, EDocket No. OAR-2001-0017


http://docket.epa.gov/edkpub/do/EDKStaffCollectionDetailView?
objectId= 0b0007d48006d9eb


URL For More Information:
http://www.epa.gov/ttn/naaqs/standards/pm/s--pm--index.html

Agency Contact:
Mary Ross
Environmental Protection Agency
Air and Radiation
C539-01
Research Triangle Park, NC 27711
Phone: 919 541-5170
Fax: 919 541-0237
Email: [email protected]

Karen Martin
Environmental Protection Agency
Air and Radiation
C539-01
Research Triangle Park, NC 27711
Phone: 919 541-5274
Fax: 919 541-0237
Email: [email protected]
RIN: 2060-AI44
_______________________________________________________________________



EPA



101. CONTROL OF HAZARDOUS AIR POLLUTANTS FROM MOBILE SOURCES

Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 7521


CFR Citation:


40 CFR Part 80; 40 CFR Part 86


Legal Deadline:


None


Abstract:


Motor vehicles are significant contributors to national emissions of 
several hazardous air pollutants. These pollutants are known or 
suspected to have serious health or environmental impacts. Reducing 
emissions of these pollutants will reduce risk to public health and 
welfare. The Clean Air Act requires EPA to periodically revise 
requirements to control emissions of these pollutants from mobile 
sources. EPA committed to this rulemaking in the preamble of the last 
rulemaking on this topic, promulgated on March 29, 2001. This rule will 
address the need for additional requirements, beyond those associated 
with existing programs and other forthcoming rules, to control 
hazardous air pollutants (``air toxics'') from motor vehicles, nonroad 
engines and vehicles, and their fuels. Previous mobile source programs 
for highway and nonroad sources and fuels have already reduced air 
toxics significantly and will provide substantial further reductions in 
coming years as new standards and programs are phased in. This mobile-
source air toxics rule will provide an overview of these mobile source 
programs and associated toxics emissions reductions. The rule will then 
address potential changes to gasoline fuel parameters to reduce toxics 
such as benzene and the potential for additional vehicle controls. We 
are also considering portable fuel container controls due to their 
significant contribution to VOC emissions overall and the potential for 
exposure to evaporative benzene emissions.


Statement of Need:


EPA has been directed by Congress under CAA section 2.2(l) to require 
motor vehicle and/or fuel standards. The statute requires the use of 
the greatest emissions reduction achievable through the use of 
technology. At a minimum, this applies to benzene and formaldehyde. EPA 
is to revise regulations ``from time to time.''


Summary of Legal Basis:


The Agency is currently negotiating a rulemaking schedule with 
plaintiffs stemming from a lawsuit brought by the Sierra Club and US 
PIRG. Recently the court ruled for the plaintiffs that EPA had a 
mandatory duty to meet the deadline established in the first MSAT rule 
(FRM in July 2004).

[[Page 64239]]

Alternatives:


A range of alternatives for the various fuel control options are being 
discussed as part of the rulemaking development process. Alternatives 
include more stringent standards for benzene control.


Anticipated Cost and Benefits:


There are potential significant health and welfare benefits associated 
with the mobile air toxics rule. Costs and benefits, including an 
analysis of the energy impacts as appropriate, will be developed as 
part of the rulemaking process.


Risks:


Impacts of the proposed standards on health indicators will be 
discussed as part of the rulemaking development.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            02/00/06
Final Action                    02/00/07

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Federalism:


 Undetermined


Additional Information:


SAN No. 4748;


Sectors Affected:


3361 Motor Vehicle Manufacturing; 3363 Motor Vehicle Parts 
Manufacturing; 32411 Petroleum Refineries; 4227 Petroleum and Petroleum 
Products Wholesalers


Agency Contact:
Christopher Lieske
Environmental Protection Agency
Air and Radiation
ASD
Ann Arbor, MI 48105
Phone: 734-214-4584
Fax: 734 214-4050
Email: [email protected]
RIN: 2060-AK70
_______________________________________________________________________



EPA



102. CLEAN AIR FINE PARTICLE IMPLEMENTATION RULE

Priority:


Other Significant


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 U.S. 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/00/05
Final Action                    11/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4752;


Agency Contact:
Rich 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
C-504-02
Research Triangle Park, NC 27711
Phone: 919 541-5556
Fax: 919 541-5489
Email: [email protected]
RIN: 2060-AK74
_______________________________________________________________________



EPA



103. PREVENTION OF SIGNIFICANT DETERIORATION (PSD) AND NONATTAINMENT 
NEW SOURCE REVIEW (NSR): ALLOWABLES PLANTWIDE APPLICABILITY LIMIT 
(PAL), AGGREGATION, AND DEBOTTLENECKING

Priority:


Other Significant


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:


These rules clarify when less than significant emissions increases from

[[Page 64240]]

multiple activities at a single major stationary source must be 
considered together for the purposes of determining major new source 
review (NSR) applicability (aggregation). We are also changing in the 
way emissions from permitted emissions units upstream or downstream 
from those undergoing a physical change or change in the method of 
operation are considered when determining if a proposed project will 
result in a significant emissions increase (debottlenecking). The rules 
also provide an allowables plantwide applicability limit (PAL) option 
that is based on the allowable emissions from major stationary sources. 
A PAL is an optional approach that provides the owners or operators of 
major stationary sources with the ability to manage facility-wide 
emissions without triggering major NSR. The added flexibility of a PAL 
allows sources to respond rapidly to market changes consistent with the 
goals of the NSR program. The regulations for aggregation and 
debottlenecking are intended to improve implementation of the program 
by articulating principles for determining major NSR applicability that 
were previously addressed through guidance only. The purpose of the 
allowables PAL rule is to encourage major stationary sources to install 
state-of-the-art controls in exchange for regulatory certainty and 
flexibility.


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. In December 2002 we promulgated NSR 
rules for a Plantwide Applicability Limit (PAL) based on actual 
emissions that apply to existing major stationary sources. In 2005, 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 allowable PAL levels, 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            02/00/06
Final Action                    02/00/07

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4793;


Agency Contact:
Juan Santiago
Environmental Protection Agency
Air and Radiation
MD C304-04
Research Triangle Park, NC 27711
Phone: 919 541-1084
Fax: 919 541-5509
Email: [email protected]

Dave Svendsgaard
Environmental Protection Agency
Air and Radiation
C339-03
Research Triangle Park, NC 27711
Phone: 919 541-2380
Fax: 919 541-5509
Email: [email protected]
RIN: 2060-AL75
_______________________________________________________________________



EPA



104. CONTROL OF EMISSIONS FROM NEW LOCOMOTIVES AND NEW MARINE DIESEL 
ENGINES LESS THAN 30 LITERS PER CYLINDER

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 7522 to 7621


CFR Citation:


40 CFR 92 and 94


Legal Deadline:


None


Abstract:


This rule will set an additional tier of more stringent exhaust 
emission standards for new locomotives and new marine compression-
ignition engines below 30 liters per cylinder. Pollutants to be 
regulated are primarily Nitrogen Oxides (NOx) and particulates. These 
new standards are expected to reflect the emission reductions 
achievable through the application of advanced emission control 
technologies, including high-efficiency catalytic exhaust emission 
control devices, and the availability and use of low-sulfur diesel 
fuel. Applying these technologies could result in a 90 percent 
reduction in exhaust emissions. The standards will build on our 
existing locomotive and marine diesel engine emission control programs, 
and will likely be modeled on our highway and nonroad diesel programs. 
The advanced technologies we are considering would take advantage of 
the fact that low-sulfur fuel for these engines will already be 
available as a result of previous regulation in our nonroad program.


Statement of Need:


Further reductions in nitrogen oxide (NOx) and particulate emissions 
are needed to help States attain national air-quality standards for 
particulates and for ozone, for which NOx is a precursor.


Summary of Legal Basis:


42 U.S.C. 7547


Alternatives:


Alternatives will be developed as the rulemaking proceeds. We recently 
issued an Advanced Notice of Proposed

[[Page 64241]]

Rulemaking to gather ideas and comments from the interested public.


Anticipated Cost and Benefits:


Cost and benefit information will be developed as the rulemaking 
proceeds. Due to the relatively small number of engines involved, it is 
likely that the annualized cost of the rule will be less than $100 
million.


Risks:


The risks addressed by this rule are primarily those resulting from 
exposure to particulate matter and ozone. Risk information will be 
quantified as the rulemaking proceeds.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           06/29/04                    69 FR 39276
NPRM                            07/00/06
Final Action                    06/00/07

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Additional Information:


SAN No. 4871;


Agency Contact:
Jean--Marie Revelt
Environmental Protection Agency
Air and Radiation
6401A
Ann Arbor, MI 48105
Phone: 734 214-4822
Email: [email protected]
RIN: 2060-AM06
_______________________________________________________________________



EPA



105. CONTROL OF EMISSIONS FROM SPARK-IGNITION ENGINES AND FUEL SYSTEMS 
FROM MARINE VESSELS AND SMALL EQUIPMENT

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 7521-7601(a)


CFR Citation:


40 CFR 90


Legal Deadline:


NPRM, Statutory, December 1, 2004.


Final, Statutory, December 31, 2005.


Abstract:


In this action, we are proposing exhaust emission standards for spark-
ignition marine engines and small land-based engines (<19 kW). We are 
also proposing evaporative emission standards for vessels and equipment 
using these engines. Nationwide, these emission sources contribute to 
ozone, carbon monoxide (CO), and particulate matter (PM) nonattainment. 
These pollutants cause a range of adverse health effects, especially in 
terms of respiratory impairment and related illnesses. The proposed 
standards would help states achieve and maintain air quality standards. 
In addition, these standards would help reduce acute exposure to CO, 
air toxics, and PM.


Statement of Need:


EPA has been directed by Congress to set new emission requirements for 
small spark-ignition (gasoline) engines. The Agency has previously 
acted to set standards for these nonroad engine source categories as 
there are significant health and welfare benefits associated with such 
controls. Even with existing standards, these sources continue to be 
contributors to air pollution inventories and further reductions will 
be helpful to State and local governments and tribes in their 
development of National Ambient Air Quality Standards plans.


Summary of Legal Basis:


Section 213 of the Clean Air Act gives EPA authority to set emissions 
requirements for nonroad engines. The engines covered under this 
proposed rulemaking are all considered nonroad engines. California may 
set its own emissions standards - unlike other mobile source 
categories, States are prohibited from adopting California emission 
standards for small spark ignition engines below 50 horsepower.


Alternatives:


A range of alternatives for the various exhaust and evaporative 
emissions standards is being discussed as part of the rulemaking 
development process. Alternatives include more stringent standards and 
different time frames for adopting the new requirements.


Anticipated Cost and Benefits:


There are potential significant health and welfare benefits associated 
with additional emissions control requirements for small spark-ignition 
engines. New standards can potentially achieve reductions in VOC 
emissions as well as other pollutants. Costs and benefits will be 
quantified and reported as part of the rulemaking process.


Risks:


Impacts of the proposed standards on health indicators will be 
discussed as part of the rulemaking development.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            01/00/06
Final Action                    01/00/07

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


SAN No. 4882;


Agency Contact:
Glenn Passavant
Environmental Protection Agency
Air and Radiation
Ann Arbor, MI 48105
Phone: 734 214-4408
Email: [email protected]
RIN: 2060-AM34
_______________________________________________________________________



EPA



106. IMPLEMENTING PERIODIC MONITORING IN FEDERAL AND STATE OPERATING 
PERMIT PROGRAMS

Priority:


Other Significant


Legal Authority:


42 USC 7401 et seq


CFR Citation:


40 CFR 70.6(c)(1); 40 CFR 71.6(c)(1); 40 CFR 64


Legal Deadline:


None


Abstract:


This rule would revise the Compliance Assurance Monitoring rule (40 CFR 
part 64) to be implemented through the operating permits rule (40 CFR 
Parts 70 and 71) to define when periodic monitoring for monitoring 
stationary source compliance must be created, and to include specific 
criteria that periodic monitoring must meet. This rule satisfies our 4-
step strategy announced in the final Umbrella Monitoring Rule

[[Page 64242]]

(published January 22, 2004) to address monitoring inadequacies. The 
four steps were: 1) To clarify the role of title V permits in 
monitoring [Umbrella Monitoring Rule]; 2) to provide guidance for 
improved monitoring in PM-Fine SIP's; 3) to take comment on correction 
of inadequate monitoring provisions in underlying rules; and 4) to 
provide guidance on periodic monitoring. A draft rule and preamble are 
scheduled for completion in October 2005. Nine States were solicited 
for monitoring requirements data in July for use in cost/benefits 
analysis.


Statement of Need:


The ''periodic monitoring'' rules, 40 CFR 70.6(a)(3)(i)(B) and 
71.6(a)(3)(i)(B), require that ``[w]here the applicable requirement 
does not require periodic testing or instrumental or noninstrumental 
monitoring (which may consist of recordkeeping designed to serve as 
monitoring), [each title V permit must contain] periodic monitoring 
sufficient to yield reliable data from the relevant time period that 
are representative of the source's compliance with the permit, as 
reported pursuant to [Sec.  70.6(a)(3)(iii) or Sec.  71.6(a)(3)(iii)]. 
Such monitoring requirements shall assure use of terms, test methods, 
units, averaging periods, and other statistical conventions consistent 
with the applicable requirement. Recordkeeping provisions may be 
sufficient to meet the requirements of [Sec. 70.6(a)(3)(i)(B) and 
Sec. 71.6(a)(3)(i)(B)].`` Sections 70.6(c)(1) and 71.6(c)(1), called 
the umbrella monitoring rule, require that each title V permit contain, 
`'[c]onsistent with paragraph (a)(3) of this section, compliance 
certification, testing, monitoring, reporting, and recordkeeping 
requirements sufficient to assure compliance with the terms and 
conditions of the permit.'' On January 22, 2004 (69 Federal Register 
3202), EPA announced that the Agency has determined that the correct 
interpretation of Sec. Sec.  70.6(c)(1) and 71.6(c)(1) is that these 
sections do not provide a basis for requiring or authorizing review and 
enhancement of existing monitoring in title V permits independent of 
any review and enhancement as may be required under the periodic 
monitoring rules, the CAM rule (40 CFR part 64)(62 FR 54900, October 
22, 1997) where it applies, and other applicable requirements under the 
Act.11 This action is to publish a separate proposed rule to address 
what monitoring constitutes periodic monitoring under Sec. Sec.  
70.6(a)(3)(i)(B) and 71.6(a)(3)(i)(B) and what types of monitoring 
should be created under these provisions. The intended effect of the 
rule revisions in this proposal is to focus case-by-case reviews on 
those applicable requirements for which we can identify potential gaps 
in the existing monitoring provisions.


Summary of Legal Basis:


Section 502(b)(2) of the Act requires EPA to promulgate regulations 
establishing minimum requirements for operating permit programs, 
including ``[m]onitoring and reporting requirements.'' 42 U.S.C. Sec.  
7661a(b)(2). Second, section 504(b) authorizes EPA to prescribe 
``procedures and methods'' for monitoring ``by rule.'' 42 U.S.C. Sec.  
7661c(b). Section 504(b) provides: ``The Administrator may by rule 
prescribe procedures and methods for determining compliance and for 
monitoring and analysis of pollutants regulated under this Act, but 
continuous emissions monitoring need not be required if alternative 
methods are available that provide sufficiently reliable and timely 
information for determining compliance. . . .'' Other provisions of 
title V refer to the monitoring required in individual operating 
permits. Section 504(c) of the Act, which contains the most detailed 
statutory language concerning monitoring, requires that ``[e]ach [title 
V permit] shall set forth inspection, entry, monitoring, compliance 
certification, and reporting requirements to assure compliance with the 
permit terms and conditions.'' 42 U.S.C. Sec.  7661c(c). Section 504(c) 
further specifies that ``[s]uch monitoring and reporting requirements 
shall conform to any applicable regulation under [section 504(b)]. . . 
.'' Section 504(a) more generally requires that ''[e]ach [title V 
permit] shall include enforceable emission limitations and standards, . 
. . and such other conditions as are necessary to assure compliance 
with applicable requirements of this Act, including the requirements of 
the applicable implementation plan.'' 42 U.S.C. Sec.  7661c(a).


Alternatives:


Some existing monitoring required under applicable requirements could 
be improved and will be addressed in connection with both the upcoming 
PM2.5 implementation rulemaking and by improving monitoring in certain 
federal rules or monitoring in SIP rules not addressed in connection 
with the PM2.5 implementation guidance or rulemaking over a longer time 
frame.


Anticipated Cost and Benefits:


We are assessing the benefits associated with improved monitoring 
including the reduction in source owner response time to potential 
excess emissions problems. Such reduced response time to take 
corrective action that will be required by the rule will result in 
measurable emissions reductions that will be balanced against the cost 
of increased equipment, data collection, and recordkeeping costs. We 
estimate the total costs of the rule to be less than $100 million.


Risks:


There are no environmental and health risks associated with 
implementing this monitoring rule; the underlying rules with emissions 
limits address those risks for each subject source category. The effect 
of the monitoring resulting from this rule will be to reduce the 
occurrence of excess emissions episodes that raise such risks.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4699.2; Split from RIN 2060-AK29.


Agency Contact:
Peter Westlin
Environmental Protection Agency
Air and Radiation
C339-02
Research Triangle Park, NC 27711
Phone: 919 541-1058
Email: [email protected]

Robin Langdon
Environmental Protection Agency
Air and Radiation
Research Triangle Park, NC 27711
Phone: 919 541-4048
Email: [email protected]
RIN: 2060-AN00

[[Page 64243]]

_______________________________________________________________________



EPA



107. FUEL ECONOMY LABELING OF MOTOR VEHICLES: REVISIONS TO IMPROVE 
CALCULATION OF FUEL ECONOMY ESTIMATES

Priority:


Other Significant


Legal Authority:


15 USC. 2001-2003; 15 USC 2005-2006; 15 USC 2013


CFR Citation:


40 CFR 600


Legal Deadline:


None


Abstract:


The Energy Policy and Conservation Act of 1974 requires EPA to 
establish regulations that require auto manufacturers to display fuel 
economy estimates on a label for each new vehicle. EPA also has 
authority to prescribe the test procedures used to calculate these fuel 
economy estimates. These estimates allow consumers to compare the fuel 
economy of different vehicles. Current window stickers have two fuel 
economy estimates, ``City'' and ``Highway.'' While actual driving 
conditions will cause variations from the EPA estimates, consumers 
should expect to achieve fuel economy that is reasonably close to those 
estimates. Since EPA last revised the methods for measuring fuel 
economy (1985), many conditions have changed - speed limits are higher, 
congestion has increased, and more vehicles are equipped with power-
hungry accessories, like air conditioning. All of these factors will 
impact a vehicle's actual fuel economy. Some of these factors - 
aggressive and high-speed driving and air conditioner use in particular 
- have been addressed in EPA emission test procedures. In the past few 
years, there has been a growing awareness by consumers indicating that 
they are experiencing lower actual fuel economy than the EPA estimates. 
EPA has examined many factors that are not currently accounted for in 
our fuel economy estimates. EPA's initial analyses indicate that the 
fuel economy label estimates are overestimated, perhaps significantly 
for some vehicles. This action will provide consumers with more 
accurate and credible information regarding the comparative fuel 
economy of vehicles. This action will amend the way in which fuel 
economy estimates are calculated, primarily by incorporating the fuel 
economy results from additional vehicle tests performed today for 
emissions compliance purposes. It will also propose changes to how the 
fuel economy estimates and other related information are presented to 
consumers on the vehicle window sticker label. The changes in this 
action will not impact the Corporate Average Fuel Economy requirements.


Statement of Need:


Numerous studies indicate that EPA's fuel economy estimates may be 
overestimated, in some cases significantly so. For example, a recent 
Consumer Reports study found that 90 percent of the vehicles they 
tested fell short of EPA estimates. Some vehicles fell short of EPA's 
city estimate by as much as 35 to 50 percent. The American Automobile 
Association (AAA) has similarly undertaken fuel economy studies, 
indicating a similar discrepancy. Although these studies differ in 
their test methods and driving conditions, they do suggest that EPA's 
approach to estimating fuel economy can be improved to better reflect 
real-world driving. Bluewater Network petitioned EPA to revise the 
methodology for estimating fuel economy, and over 10,000 comments filed 
with EPA support improving the accuracy of the fuel economy labels that 
appear on new vehicles.


A fundamental issue is that today's test methods do not represent real-
world driving conditions. For example, the highway test has a top speed 
of only 60 miles per hour, the city and highway tests are run at mild 
climatic conditions (75 deg F), acceleration rates are mild due to 
equipment limitations of the 1970's, and neither test is run with 
accessory use such as air conditioning. In the 1990's EPA added new 
emission tests after documenting a disconnect between existing test 
procedures and characteristics of real-world driving, but fuel economy 
tests remained unchanged. These new emission tests capture the effects 
of higher speeds, more aggressive acceleration rates, and the use of 
air conditioning at higher temperatures.


Additionally, cars and automotive technology have evolved since 1985, 
the last time EPA adjusted the fuel economy label methodology. The 
penetration of air conditioning in the automotive fleet, for example, 
has increased significantly. The performance and weight of automobiles 
has steadily increased for the last 25-30 years. Since 1985, 
acceleration rates have improved by 30 percent on average, average 
horsepower has increased by about 75 percent, and average vehicle 
weight has increased by about 25 percent. Driving conditions have also 
changed, with longer commutes and more time spent in slow, high-traffic 
conditions. All these factors have the potential of affecting fuel 
economy.


Summary of Legal Basis:


Section 774 of the Energy Policy Act of 2005 Congress requires EPA to 
update the fuel economy label calculation methodology to reflect a 
variety of factors not currently accounted for in the existing test 
procedures. Section 774 directs EPA to ``. . .update or revise the 
adjustment factors in sections 600.209-85 and 600.209-95, of the Code 
of Federal Regulations, CFR Part 600 (1995) Fuel Economy Regulations 
for 1977 and Later Model Year Automobiles to take into consideration 
higher speed limits, faster acceleration rates, variations in 
temperature, use of air conditioning, shorter city test cycle lengths, 
current reference fuels, and the use of other fuel depleting 
features.``


Alternatives:


We are considering several broad options (note that none of these 
options would impact the calculation of fuel economy for Corporate 
Average Fuel Economy (CAFE) requirements). These include:


1. Take No Action


2. Revise Current Adjustment Factors


3. Add New Fuel Economy Tests to Current Tests


4. Propose New Test Procedures for Fuel Economy and Emissions


Anticipated Cost and Benefits:


Costs and benefits will be quantified and reported as part of the 
rulemaking process.


Risks:


There are no anticipated risk impacts associated with this action.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM-                           01/00/06
Final Action-                   12/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal

[[Page 64244]]

Additional Information:


SAN No. 4962;


Agency Contact:
Roberts French
Environmental Protection Agency
Air and Radiation
1200 Pennsylvania Ave
Washington, DC 20460
Phone: 734 214-4380
Fax: 734 214-4050
Email: [email protected]

Robin Moran
Environmental Protection Agency
Air and Radiation
1200 Pennsylvania Ave, NW
Washington, DC 20460
Phone: 734 214-4781
Fax: 734 214-4816
Email: [email protected]
RIN: 2060-AN14
_______________________________________________________________________



EPA



108. AMENDMENT OF THE STANDARDS FOR RADIOACTIVE WASTE DISPOSAL IN YUCCA 
MOUNTAIN, NEVADA

Priority:


Other Significant


Legal Authority:


PL 102-486


CFR Citation:


40 CFR 197


Legal Deadline:


None


Abstract:


This action will amend the standards for Yucca Mountain, Nevada (40 CFR 
Part 197). These standards were issued in 2001 and were partially 
remanded by a Federal court in 2004. These amendments will address the 
remanded portion of the standards, viz., the compliance period. Yucca 
Mountain is the site of a potential geologic repository for spent 
nuclear fuel and high-level radioactive waste. It is about 100 miles 
northwest of Las Vegas, Nevada, and straddles the boundaries of the 
Nevada Test Site, Bureau of Land Management land, and an Air Force 
bombing range. The site is being developed by the Department of Energy 
(DOE). The DOE will submit a license application to the Nuclear 
Regulatory Commission (NRC). We (EPA) were given the authority to set 
Yucca Mountain-specific standards in the Energy Policy Act of 1992 
(EnPA). The EnPA also requires NRC to adopt our standards in its 
licensing regulations and use them as a basis to judge compliance of 
the repository's performance. The Agency issued final Yucca Mountain 
standards in 2001. In July 2004, the DC Circuit Court returned the 
standards to EPA for reconsideration of the regulatory time frame. The 
Court found that the 10,000-year compliance period violates our 
authorizing statute for Yucca Mountain regulation because it is not 
``based upon and consistent with'' scientific recommendations required 
from the National Academy of Sciences under the legislation. To address 
the Court's opinion, we must reassess the time frame in light of the 
National Academy's recommendation that compliance must be addressed at 
the time of peak dose, which may be as long as several hundred thousand 
years into the future.


Statement of Need:


Congress selected Yucca Mountain as the Nation's only candidate site 
for a repository for nuclear spent fuel and high-level radioactive 
waste. The Energy Policy Act of 1992 requires EPA to set Yucca-
Mountain-specific standards. Standards were promulgated in 2001. In 
July 2004, the DC Circuit Court returned the standards to EPA for 
reconsideration of the regulatory time frame.


Summary of Legal Basis:


The Energy Policy Act of 1992 requires EPA to set Yucca-Mountain-
specific standards. Standards were promulgated in 2001. In July 2004, 
the DC Circuit Court returned the standards to EPA for reconsideration 
of the regulatory time frame.


Alternatives:


To address the Court's opinion, we must reassess the time frame in 
light of the National Academy's recommendation that compliance must be 
addressed at the time of peak dose, which may be as long as several 
hundred thousand years into the future. Alternatives addressing that 
recommendation will be developed as the rulemaking proceeds.


Anticipated Cost and Benefits:


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


Risks:


Risk information will be developed as the rulemaking proceeds.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Additional Information:


SAN No. 4964;


Agency Contact:
Ray Clark
Environmental Protection Agency
Air and Radiation
6608J
Washington, DC 20460
Phone: 202 343-9198
Fax: 202 343-2065
Email: [email protected]

Raymond Lee
Environmental Protection Agency
Air and Radiation
6608J
Washington, DC 20460
Phone: 202 343-9463
Fax: 202 343-2503
Email: [email protected]
RIN: 2060-AN15
_______________________________________________________________________



EPA



109.  REVIEW OF THE NATIONAL AMBIENT AIR QUALITY STANDARDS FOR 
OZONE

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 7408; 42 USC7409


CFR Citation:


40 CFR 50


Legal Deadline:


Final, Statutory, July 18, 2002, CAA Amendments of 1977.


NPRM, Judicial, March 28, 2007, Consent Decree.


Final, Judicial, December 19, 2007, Consent Decree.


Abstract:


The Clean Air Act Amendments of 1977 require EPA to review and, if 
necessary, revise National Ambient Air Quality Standards (NAAQS)

[[Page 64245]]

periodically. On July 18, 1997, the EPA published a final rule revising 
the NAAQS for ozone. The primary and secondary NAAQS were strengthened 
to provide increased protection against both health and environmental 
effects of ozone. The EPA's work plan/schedule for the next review of 
the ozone Criteria Document was published on November 2002. The first 
external review draft Criteria Document, a rigorous assessment of 
relevant scientific information, was released on January 31, 2005. The 
EPA's Office of Air Quality Planning and Standards will prepare a Staff 
Paper for the Administrator, which will evaluate the policy 
implications of the key studies and scientific information contained in 
the Criteria Document and additional technical analyses, and identify 
critical elements that EPA staff believe should be considered in 
reviewing the standards. The Criteria Document and Staff Paper will be 
reviewed by the Clean Air Scientific Advisory Committee and the public, 
and both final documents will reflect the input received through these 
reviews. As the ozone NAAQS review is completed, the Administrator's 
proposal to reaffirm or revise the ozone NAAQS will be published with a 
request for public comment. Input received during the public comment 
period will be considered in the Administrator's final decision.


Statement of Need:


As established in the Clean Air Act, the national ambient air quality 
standards for ozone are to be reviewed every five years.


Summary of Legal Basis:


Section 109 of the Clean Air Act (42 USC 7409) directs the 
Administrator to propose and promulgate ``primary'' and ``secondary'' 
national ambient air quality standards for pollutants identified under 
section 108 (the ``criteria'' pollutants). The ``primary'' standards 
are established for the protection of public health, while 
``secondary'' standards are to protect against public welfare or 
ecosystem effects.


Alternatives:


The main alternatives for the Administrator's decision on the review of 
the national ambient air quality standards for ozone are whether to 
reaffirm or revise the existing standards.


Anticipated Cost and Benefits:


Costs and benefits of revising or reaffirming the national ambient air 
quality standards for ozone cannot be determined at present; a 
regulatory impact analysis will be conducted along with the review of 
the standards.


Risks:


The current national ambient air quality standards for ozone are 
intended to protect against public health risks associated with 
morbidity and/or premature mortality and public welfare risks 
associated with adverse vegetation and ecosystem effects. During the 
course of this review, risk assessments will be conducted to evaluate 
health and welfare risks associated with retention or revision of the 
ozone standards.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/00/07
Final Action                    12/00/07

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 Undetermined


Additional Information:


SAN No. 5008;


Agency Contact:
David McKee
Environmental Protection Agency
Air and Radiation
C 539-01
Research Triangle Park NC, DC 27711
Phone: 919 541-5288
Fax: 919 541-0237
Email: [email protected]

Karen Martin
Environmental Protection Agency
Air and Radiation
C539-01
Research Triangle Park, NC 27711
Phone: 919 541-5274
Fax: 919 541-0237
Email: [email protected]
RIN: 2060-AN24
_______________________________________________________________________



EPA



110.  PREVENTION OF SIGNIFICANT DETERIORATION AND NONATTAINMENT 
NEW SOURCE REVIEW: ALTERNATIVE APPLICABILITY TEST FOR ELECTRIC 
GENERATING UNITS

Priority:


Other Significant


Legal Authority:


Clean Air Act, Title I Parts C and D and Section 111(a)(4)


CFR Citation:


40 CFR Part 51; 40 CFR Part 52


Legal Deadline:


None


Abstract:


This rulemaking would create an alternative applicability test for 
existing electric generating units (EGUs) that are subject to the 
regulations governing the Prevention of Significant Deterioration (PSD) 
and nonattainment major New Source Review (NSR) programs mandated by 
parts C and D of title I of the Clean Air Act (CAA). This alternative 
applicability test would be available for EGUs that are also subject to 
the EPA-administered Clean Air Interstate Rule (CAIR) NOx Annual 
Trading Program or the CAIR SO2 Trading Program. This alternative 
applicability test could be extended to other CAIR and non-CAIR EGUs. 
For existing major stationary sources, the NSR base program 
applicability test is applied when the source proposes to modify an 
emissions unit such that the change is a physical change or change in 
the method of operation, and the test compares actual emissions to 
either potential emissions or projected actual emissions. Under this 
rulemaking's alternative NSR applicability test (a maximum hourly test 
like that used in the NSPS program), we would compare the EGU's maximum 
hourly emissions (considering controls) before the change for the past 
5 years to the maximum hourly emissions after the change.


Statement of Need:


Utilization of this rulemaking's alternative NSR applicability test for 
existing EGUs would encourage increased utilization at the more 
efficient units by displacing energy production at less efficient ones.


Summary of Legal Basis:


Parts C and D of title I of the Clean Air Act; CAA section 111(a)(4)

[[Page 64246]]

Alternatives:


The proposed basis for the applicability test is a comparison of 
maximum hourly emissions, which will enhance the implementation and 
environmental benefits for existing EGUs. We request comment on 
alternative bases for an alternative applicability test.


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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4794.2; Split from RIN 2060-AM95.


URL For More Information:
www.epa.gov/nsr

Agency Contact:
Janet McDonald
Environmental Protection Agency
Air and Radiation
C339-03
Research Triangle Park, NC 27711
Phone: 919 541-1450
Fax: 919 541-5509
Email: [email protected]

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]
RIN: 2060-AN28
_______________________________________________________________________



EPA



111.  RENEWABLE FUEL STANDARDS REQUIREMENTS FOR 2006

Priority:


Other Significant


Legal Authority:


PL 109-58, sec 1501


CFR Citation:


Not Yet Determined


Legal Deadline:


None


Abstract:


The Energy Policy Act of 2005 (the ``Act''), signed into law on August 
8, 2005, requires EPA to promulgate regulations implementing the 
Renewable Fuels Standard (RFS) within one year of enactment. The RFS 
requires specific volumes of renewable fuel to be in gasoline sold in 
the U.S. starting with 4.0 billion gal/yr in 2006 up to 7.5 billion 
gal/yr in 2012. The Act provides that if EPA fails to promulgate 
regulations within one year, then a default value of 2.78% renewable 
fuel in gasoline will be in effect for 2006. This statutory provision 
is subject to multiple interpretations of key terms. The ``Renewable 
Fuel Standard Requirements for 2006'' that we are proposing will 
interpret the default provision so that it can be implemented with 
certainty in the event EPA fails to promulgate the RFS within one year 
of enactment. It provides for refiners, importers and blenders to meet 
the 2.78% requirement collectively, rather than on an individual basis. 
Since our projections show that this value is highly likely to be met 
in 2006 under planned practices of the refining industry, we do not 
anticipate any impacts on the industry in general, nor any on small 
businesses. It will have no effect on state, local or tribal 
governments.


Statement of Need:


This regulation will provide certainty to the refining industry in the 
early part of 2006 so they understand what the requirements and 
obligations are for the industry in case the default standard should 
become effective.


Summary of Legal Basis:


The Energy Policy Act of 2005 (the Act) requires EPA to promulgate 
regulations that implement a renewable fuel standard (RFS) within one 
year of enactment. The Act also contains a provision that allows a 
default standard of 2.78% renewable fuels in gasoline for 2006, should 
EPA fail to promulgate the regulations by the required date.


Alternatives:


A range of alternatives are being discussed as part of the major RFS 
rulemaking development process that will follow the default standard 
rulemaking. Alternatives for the default rulemaking may include 
provisions to allow for crediting if the default standard is exceeded.


Anticipated Cost and Benefits:


There are potential significant health and welfare benefits associated 
with the mobile air toxics rule. Costs and benefits, including an 
analysis of the energy impacts as appropriate, will be developed as 
part of the rulemaking process.


Risks:


The rule will impose no risks beyond those inherent in the statutory 
requirement.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05
Final Action                    03/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Additional Information:


SAN 5024


Agency Contact:
Barry Garelick
Environmental Protection Agency
Air and Radiation
6406J
Phone: 202 564-9028
Fax: 202 564-2085
Email: [email protected]

David Korotney
Environmental Protection Agency
Air and Radiation
6407
Ann Arbor, MI 48105
Phone: 734 214-4507
Fax: 734 214-4050
Email: [email protected]
RIN: 2060-AN51
_______________________________________________________________________



EPA



112. LEAD-BASED PAINT ACTIVITIES; AMENDMENTS FOR RENOVATION, REPAIR AND 
PAINTING

Priority:


Economically Significant. Major under 5 USC 801.

[[Page 64247]]

Unfunded Mandates:


Undetermined


Legal Authority:


15 USC 2682 ``TSCA 4 402''


CFR Citation:


40 CFR 745


Legal Deadline:


Final, Statutory, October 28, 1996.


Abstract:


The Environmental Protection Agency is developing a comprehensive 
program for the management of renovation, repair and painting 
activities involving lead based paint hazards. The program will be 
comprised of a combination of approaches including an extensive 
education and outreach campaign for lead-safe work practices and 
training for industry, an outreach campaign designed to expand consumer 
awareness and create demand for the use of lead-safe work practices, 
and the proposal of regulatory requirements. Specifically, the Agency 
will be proposing regulatory requirements for renovation, repair and 
painting contractors involved in activities where, as a result of their 
work, lead hazards are created. Modifications to the abatement 
requirements will also be considered to ensure compatibility between 
the existing requirements and any future renovation requirements.


Statement of Need:


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


Summary of Legal Basis:


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


Alternatives:


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


Anticipated Cost and Benefits:


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


Risks:


These rules are aimed at reducing the prevalence and severity of lead 
poisoning, particularly in children. The Agency has concluded that many 
R&R work activities can produce or release large quantities of lead and 
may be associated with elevated blood lead levels. These activities 
include, but are not limited to: sanding, cutting, window replacement, 
and demolition. Lead exposure to R&R workers appears to 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, Local, State, Tribal


Federalism:


 Undetermined


Additional Information:


SAN No. 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


URL For More Information:
http://www.epa.gov/oppt/lead/

Agency Contact:
Cindy Wheeler
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7404T
Washington, DC 20460
Phone: 202 566-0484
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

[[Page 64248]]

_______________________________________________________________________



EPA



113. NOTIFICATION OF CHEMICAL EXPORTS UNDER TSCA SECTION 12(B)

Priority:


Other Significant


Legal Authority:


15 USC 2611


CFR Citation:


40 CFR 707


Legal Deadline:


None


Abstract:


Section 12(b)(2) of the Toxic Substances Control Act (TSCA) states, in 
part, that any person who exports or intends to export to a foreign 
country a chemical substance or mixture for which submission of data is 
required under section 4 or 5(b), or for which a rule, action or order 
has been proposed or promulgated under section 5, 6, or 7, shall notify 
the EPA Administrator of such export or intent to export. The 
Administrator in turn will notify the government of the importing 
country of EPA's regulatory action with respect to the substance. As 
part of OMB's Regulatory Reform of the U.S. Manufacturing Sector Report 
(2005), commenters expressed concern that the existing TSCA section 
12(b) regulations do not provide a low-level cut-off for the export 
notification requirements. To address that concern, EPA committed to 
OMB that it would consider potential changes to the TSCA section 12(b) 
regulation within the scope of existing statutory authority and issue a 
proposed amendment to address the concern expressed by January 2006. 
Legislation is currently pending to address the implementation in the 
U.S. of the Rotterdam Convention on Prior Informed Consent (PIC), which 
itself includes export notification requirements.


Statement of Need:


Industry nominated the implementing regulations for reform 
consideration twice. First in 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. (See OMB's compilation of comments, summary 
190, pg 10, commenter 12 available at http://
www.whitehouse.gov/omb/inforeg/key--comments.html.) And then again in 
2004, see 39 in OMB's Regulatory Reform of the U.S. 
Manufacturing Sector Report (2005).


Summary of Legal Basis:


Section 12(b)(2) of the Toxic Substances Control Act (TSCA).


Alternatives:


To be determined.


Anticipated Cost and Benefits:


Minimal, but yet to be determined.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Additional Information:


SAN No. 4858;


URL For More Information:
www.epa.gov/opptintr/chemtest/12b.htm

Agency Contact:
Greg Schweer
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202 564-8469
Fax: 202 564-4765
Email: [email protected]

Dave Williams
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202 564-8179
Fax: 202 564-4765
Email: [email protected]
RIN: 2070-AJ01
_______________________________________________________________________



EPA



114. ADMINISTRATIVE REPORTING EXEMPTION FOR CERTAIN AIR RELEASES OF NOX

Priority:


Other Significant


Legal Authority:


42 USC 9603


CFR Citation:


40 CFR 302.6(c); 40 CFR 355.40


Legal Deadline:


None


Abstract:


The Agency is considering administratively exempting from reporting 
requirements the releases of certain NOx emissions to air. This would 
eliminate reports from facilities emitting NOx where the Agency has 
determined that the releases pose little or no risk or to which a 
Federal response is infeasible or inappropriate. Requiring reports of 
such releases would serve little or no useful purpose and could, 
instead, impose a significant burden on the Federal response system and 
on the persons responsible for notifying the Federal Government of the 
release.


Statement of Need:


Pursuant to the terms of Executive Order 12866, it has been determined 
that this rule is a ``significant regulatory action'' because it raises 
novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in the Executive 
Order. This rule, if finalized, will eliminate or substantially reduce 
certain Federal regulatory notification requirements.


Summary of Legal Basis:


The Comprehensive Environmental Response, Compensation, and Liability 
Act of 1980 (CERCLA), 42 U.S.C. 9601 et seq., as amended by the 
Superfund Amendments and Reauthorization Act of 1986, gives the Federal 
Government broad authority to respond to releases or threats of 
releases of hazardous substances from vessels and facilities. The term 
``hazardous substance'' is defined in section 101(14) of CERCLA 
primarily by reference to other Federal environmental statutes. Section 
102 of CERCLA gives the U.S. Environmental Protection Agency (EPA) 
authority to designate additional hazardous substances. Under CERCLA 
section 103(a), the person in charge of a vessel or facility from which 
a CERCLA

[[Page 64249]]

hazardous substance has been released in a quantity that equals or 
exceeds its reportable quantity (RQ) must immediately notify the 
National Response Center (NRC) of the release. A release is reportable 
if an RQ or more is released within a 24-hour period (see 40 CFR 
302.6). This reporting requirement, among other things, serves as a 
trigger for informing the Government of a release so that Federal 
personnel can evaluate the need for a Federal removal or remedial 
action and undertake any necessary action in a timely fashion. In 
addition to the reporting requirements established pursuant to CERCLA 
section 103, section 304 of the Emergency Planning and Community Right-
to-Know Act of 1986 (EPCRA), 42 U.S.C. 11001 et seq., requires the 
owner or operator of certain facilities to immediately report releases 
of CERCLA hazardous substances or any extremely hazardous substances to 
State and local authorities (see 40 CFR 355.40).


Alternatives:


EPA is also considering the appropriateness of alternative options to 
address the CERCLA Sec. 103 and EPCRA Sec. 304 Reporting Requirements 
of Certain Unpermitted Releases of NOx to the air. Those options 
include; a) more efficient use of Continuous Release reporting, and b) 
extending the administrative reporting exemption to include all 
releases of NOx from combustion sources that are not the result of an 
accident or malfunction.


Anticipated Cost and Benefits:


The Agency estimates for industry an annual overall reduction of cost 
from $16,380,571 to $15,994,833 an overall reduction of $385,738 with a 
corresponding reduction in the hour burden from 382,890 to 376,385 a 
reduction of 6,505 hours. This represents an overall reduction in the 
likely number of respondents from 27,227 to 25,762 a reduction of 1,465 
respondents.


Risks:


Not applicable.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/04/05                    70 FR 57813
Final Action                    10/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Additional Information:


SAN No. 4736


Agency Contact:
Lynn Beasley
Environmental Protection Agency
Solid Waste and Emergency Response
5104A
Washington, DC 20460
Phone: 202 564-1965
Fax: 202 564-2625
Email: [email protected]
RIN: 2050-AF02
_______________________________________________________________________



EPA



115. REVISIONS TO THE SPILL PREVENTION, CONTROL, AND COUNTERMEASURE 
(SPCC) RULE, 40 CFR PART 112

Priority:


Other Significant


Unfunded Mandates:


Undetermined


Legal Authority:


33 USC 1321


CFR Citation:


40 CFR 112


Legal Deadline:


None


Abstract:


EPA will propose to amend 40 CFR part 112, which includes the Spill 
Prevention, Control, and Countermeasure (SPCC) rule promulgated under 
the authority of the Clean Water Act. The proposed rule may include a 
variety of issues associated with the July 2002 SPCC final rule. 
Specific decisions on the scope of the rulemaking will be determined 
after the final rule associated with the Notices of Data Availability 
has been completed and in relation to EPA guidance.


Statement of Need:


The proposed rule is necessary to clarify the regulatory obligations of 
SPCC facility owners and operators and to reduce the regulatory burden 
where appropriate.


Summary of Legal Basis:


The legal basis is 33 USC 1321 et seq.


Alternatives:


Undetermined.


Anticipated Cost and Benefits:


Undetermined.


Risks:


Undetermined.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Notice Clarifying Certain 
    Issues                      05/25/04                    69 FR 29728
NPRM 1 yr Compliance 
    Extension                   06/17/04                    69 FR 34014
Final 18 months 
    Compliance Extension        08/11/04                    69 FR 48794
NODA re certain 
    facilities                  09/20/04                    69 FR 56184
NODA re oil-filled and 
    process equipment           09/20/04                    69 FR 56182
NPRM                            06/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 2634.2; Split from RIN 2050-AC62.


Agency Contact:
Hugo Fleischman
Environmental Protection Agency
Solid Waste and Emergency Response
5104A
Washington, DC 20460
Phone: 202 564-1968
Fax: 202 564-2625
Email: [email protected]
RIN: 2050-AG16
_______________________________________________________________________



EPA



116. REGULATORY ACTIONS ASSOCIATED WITH THE NOTICES OF DATA 
AVAILABILITY ON THE SPILL PREVENTION, CONTROL, AND COUNTERMEASURE 
(SPCC) RULE, 40 CFR PART 112

Priority:


Other Significant


Legal Authority:


33 USC 1321


CFR Citation:


40 CFR 112


Legal Deadline:


None


Abstract:


On September 20, 2004, the Environmental Protection Agency (EPA)

[[Page 64250]]

issued two Notices of Data Availability (NODAs) concerning certain 
facilities and oil-filled and process equipment. Based on our review of 
the information received from the NODAs, EPA is considering additional 
measures to ease the compliance burden of smaller facilities and for 
oil-filled equipment. EPA intends to define those facilities and oil-
filled equipment for which EPA plans to propose streamlined SPCC Plan 
requirements, and extend or otherwise address the February 2006 
compliance deadline for SPCC Plan revisions for this affected universe. 
EPA is also considering (1) an indefinite extension of the compliance 
dates for a defined category of farms; (2) a definition and regulatory 
relief for motive power containers and airport mobile refuelers; and 
(3) removing the inapplicable requirements for Animal Fats and 
Vegetable Oils (AFVOs).


Statement of Need:


EPA is clarifying, extending and modifying the regulatory requirements 
for facilities subject to the SPCC rule. This is part of EPA's multi-
phased strategy to address concerns with the current SPCC regulation.


Summary of Legal Basis:


The legal basis is 33 USC 1321 et seq.


Alternatives:


Undetermined at this time.


Anticipated Cost and Benefits:


Undetermined at this time.


Risks:


Undetermined at this time.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NODA re certain 
    facilities-                 09/20/04                    69 FR 56184
NODA re oil-filled and 
    process equipment-          09/20/04                    69 FR 56182
NPRM                            10/00/05
Final Action                    02/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 2634.3; Split from RIN 2050-AG16.


Agency Contact:
Vanessa Rodriguez
Environmental Protection Agency
Solid Waste and Emergency Response
5104A
Washington, DC 20460
Phone: 202 564-7913
Fax: 202 564-2625
Email: [email protected]
RIN: 2050-AG23
_______________________________________________________________________



EPA



117. EXPANDING THE COMPARABLE FUELS EXCLUSION UNDER RCRA

Priority:


Other Significant


Legal Authority:


RCRA 4004


CFR Citation:


40 CFR 261.38


Legal Deadline:


None


Abstract:


EPA currently excludes specific industrial wastes, also known as 
comparable fuels, from the Resource Conservation and Recovery Act 
(RCRA) when they are used for energy production and do not contain 
hazardous constituent levels that exceed those found in a typical 
benchmark fuel that facilities would otherwise use. Using such wastes 
as fuel saves energy by reducing the amount of hazardous waste that 
would otherwise be treated and disposed, promotes energy production 
from a domestic, renewable source, and reduces use of fossil fuels. 
With an interest in supplementing the nation's energy supplies, EPA, as 
part of the Resource Conservation Challenge, is examining the 
effectiveness of the current comparable fuel program and considering 
whether other industrial wastes could be safely used as fuel as well.


Statement of Need:


EPA is considering expanding the comparable fuels program. This program 
allows specific industrial wastes to be excluded from the Resource 
Conservation and Recovery Act (RCRA) when they are used for energy 
production and do not contain hazardous constituent levels exceeding 
those in a typical benchmark fuel that facilities would otherwise use. 
If EPA is successful in finding other industrial wastes that could be 
used for energy, this would not only save energy by reducing the amount 
of hazardous waste that would be otherwise treated and disposed, but 
also promote energy production from a domestic, renewable source and 
reduce our use of fossil fuels. EPA is also examining the effectiveness 
of the current comparable fuel program to determine whether changes 
could be made to the existing program to make it more effective.


Summary of Legal Basis:


This action is discretionary on the Agency's part.


Alternatives:


To make significant changes to the existing comparable fuels standard, 
EPA must modify the existing regulations. EPA intends to first propose 
and seek comment on potential regulatory modifications.


Anticipated Cost and Benefits:


When the existing comparable fuel exemption was established, EPA 
estimated that the rule would result in annual savings of 11 to 36 
million dollars for generators and would result in annual costs of 3 to 
13 million dollars for hazardous waste combustors. The savings to 
generators were made up of avoided hazardous waste combustion costs and 
revenues from sale of comparable fuels, less the analytical costs. 
Costs to hazardous waste combustion facilities stem from lost revenue 
from wastes are diverted to the comparable fuels market. EPA has not 
conducted a preliminary estimate of costs and benefits from 
modifications to the existing comparable fuels rule, as options to be 
proposed have not been selected. Prior to proposing options, EPA 
intends to reach out to a broad group of stakeholders to receive input 
on potential regulatory approaches that could be proposed. When EPA 
selects the approaches to be proposed, we will be in a position to 
estimate costs and benefits of any regulatory actions.


Risks:


The rationale for the Agency's approach to establishing the existing 
comparable fuels standards is that if a hazardous waste-derived fuel is 
comparable to a fossil fuel in terms of hazardous and other key 
constituents and has a heating value indicative of a fuel, EPA has 
discretion to classify such material as a fuel product, not as a waste. 
Given that a comparable fuel would have legitimate energy value and the 
same hazardous constituents in comparable concentrations to those in 
fossil fuel

[[Page 64251]]

(and satisfies other parameters related to comparability as well), 
classifying such material as a fuel product and not as a waste promotes 
RCRA's resource recovery goals without creating any risk greater than 
those posed by the commonly used commercial fuels. If EPA maintains 
this ``benchmark'' approach in its revisions, the risks associated with 
any changes will remain unchanged. Until EPA establishes what 
approaches to propose for modifications to the comparable fuel 
standards, it is not possible to provide a description of the risks 
associated with such a proposal.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM-                           09/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4977;


Agency Contact:
Scott Rauenzahn
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington DC, DC 20460
Phone: 703 308-8477
Fax: 703 308-8433
Email: [email protected]

Hugh Davis
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703 306-0206
Fax: 703 308-8433
Email: [email protected]
RIN: 2050-AG24
_______________________________________________________________________



EPA



118. TOXICS RELEASE INVENTORY REPORTING BURDEN REDUCTION RULE

Priority:


Other Significant


Legal Authority:


42 USC 11023 et seq


CFR Citation:


40 CFR 372


Legal Deadline:


None


Abstract:


The primary goal of this effort by EPA is to reduce burdens associated 
with Toxics Release Inventory (TRI) reporting while at the same time 
continuing to provide valuable information to the public consistent 
with the goals and statutory requirements of the TRI program.


Statement of Need:


EPA is looking to explore various options with the intention of 
identifying a specific burden reduction initiative that effectively 
lessens the burden on facilities but at the same time ensures that TRI 
continues to provide communities with the same high level of 
significant chemical release and other waste management information.


Summary of Legal Basis:


Section 313 of the Emergency Planning and Community Right-to-Know Act 
(EPCRA) of 1986 and section 6607 of the Pollution Prevention Act (PPA) 
of 1990.


Alternatives:


Still Under Analysis.


Anticipated Cost and Benefits:


Still Under Analysis.


Risks:


Not Applicable.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/00/05
Final Action                    02/00/07

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4896;


URL For More Information:
www.epa.gov/tri

Agency Contact:
Cassandra Vail
Environmental Protection Agency
Office of Environmental Information
2844T
Washington, DC 20460
Phone: 202 566-0753
Fax: 202 566-0715
Email: [email protected]

Kevin--E Donovan
Environmental Protection Agency
Office of Environmental Information
2844T
Washington, DC 20460
Phone: 202 566-0676
Fax: 202 566-0741
Email: [email protected]
RIN: 2025-AA14
_______________________________________________________________________



EPA

                              -----------

                            FINAL RULE STAGE

                              -----------




119. INCLUSION OF DELAWARE AND NEW JERSEY IN THE CLEAN AIR INTERSTATE 
RULE

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 7410(a)


CFR Citation:


40 CFR Part 51; 40 CFR Part 72; 40 CFR Part 73; 40 CFR Part 74; 40 CFR 
Part 77; 40 CFR Part 78; 40 CFR Part 96


Legal Deadline:


None


Abstract:


In the Clean Air Interstate rule(CAIR), EPA adopted a single-factor 
threshold of 0.20 mg/m3 contribution to PM2.5 nonattainment as the air 
quality element of the definition of emissions that contribute 
significantly to nonattainment in another state. Upon further 
consideration, EPA believes that this may exclude some states that 
should be considered to make a significant contribution if their future 
emissions are not reduced below presently projected levels. On May 12, 
2005, we proposed to supplement the contribution threshold adopted in 
the CAIR with a multi-factor weight of evidence test (70 FR 25408). We 
published a notice of data availability on June 28, 2005 (70 FR 37068) 
to notify the public we had put additional

[[Page 64252]]

information in the docket regarding the inclusion of Delaware and New 
Jersey. Application of the test indicates that New Jersey and Delaware 
should be included in the CAIR requirements. In this action, we are 
responding to comments received on the proposal.


Statement of Need:


The Clean Air Act requires that a State take steps to prevent emissions 
from sources located within its boundaries from interfering with a 
downwind State's ability to meet air quality standards, or interfering 
with measures to protect visibility. EPA believes it is important to 
address interstate transport for the PM2.5 and 8-hour ozone standards 
prior to the time when State plans addressing nonattainment of the 
standards are completed, so that States can rely on upwind reductions 
when developing plans for attaining the standards. Analysis has shown 
that additional reductions in PM2.5 and ozone precursors are necessary 
as one part of an attainment strategy for downwind states. This 
rulemaking would achieve the needed reductions, either in lieu of or in 
combination with possible legislation such as the President's Clear 
Skies bill.


Summary of Legal Basis:


Clean Air Act section 110(a)(2)(D) [42 USC 7410(a)(2)(D)] requires that 
each State's implementation plan include the ``good neighbor'' 
provisions of prohibiting sources in the State from emitting air 
pollutants in amounts that contribute significantly to nonattainment in 
a downwind state, or interfere with measures to protect visibility in a 
Class I areas. Section 110(a)(1) [42 USC 7410(a)(1)] requires States to 
submit implementation plans within a specified period of time after the 
promulgation of a new or revised national ambient air quality standard. 
In addition, EPA has authority under section 110(k)(5) [42 USC 
7410(k)(5)] to require States to revise existing implementation plans 
whenever EPA finds that those plans are inadequate to comply with any 
requirement. Further, section 301(a)(1) [42 USC 7601(a)(1)] confers 
general authority upon the EPA Administrator. These provisions of the 
Clean Air Act, taken together, confer authority on EPA to promulgate 
the present regulations.


Alternatives:


There are several alternatives to a federal interstate transport rule. 
The Clear Skies Act proposed by the Bush Administration will, if 
enacted, help reduce interstate transport of pollution from the largest 
emitters in the power generation sector. However, Congressional 
approval is not guaranteed, and all emissions sources contributing to 
interstate transport may not be addressed. Another alternative is to 
wait for States to submit plans under Clean Air Act (CAA) section 
110(a), and for EPA to review these plans for compliance with the 
transport provisions of CAA section 110(a)(2)(D). Past experience 
indicates that it would be difficult for individual upwind States to 
adopt transport controls without EPA defining their reduction 
responsibilities in advance. Further, EPA is concerned that the States 
do not yet have the analytical tools needed to assess their 
contribution to transport. Another alternative is to wait for 
individual States to submit petitions under CAA section 126 that call 
for EPA to address interstate transport. In this case it would be 
necessary for EPA to respond by identifying the collective scope and 
magnitude of the interstate transport problem, and defining a 
collective solution. This rulemaking accomplishes this same goal, but 
will accomplish it earlier so that States can rely on upwind reductions 
when developing plans for attaining the standards.


Anticipated Cost and Benefits:


Cost and benefit calculations will be made as the rulemaking proceeds.


Risks:


The risks addressed are the health and welfare impacts resulting from 
nonattainment of the NAAQS for fine particulate matter and ozone, and 
from emissions that interfere with measures to protect visibility in 
Class I areas.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            05/12/05                    70 FR 25408
NODA                            06/28/05                    70 FR 37068
Final Action                    11/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Energy Effects:


 Statement of Energy Effects planned as required by Executive Order 
13211.


Additional Information:


SAN No. 4794.1; Split from RIN 2060-AL76.


URL For More Information:
www.epa.gov/interstateairquality

Agency Contact:
Jan King
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 27711
Phone: 919 541-5665
Email: [email protected]

Joe Paisie
Environmental Protection Agency
Air and Radiation
C-504-02
Research Triangle Park, NC 27711
Phone: 919 541-5556
Fax: 919 541-5489
Email: [email protected]
RIN: 2060-AM95
_______________________________________________________________________



EPA



120. RULE ON SECTION 126 PETITION FROM NC TO REDUCE INTERSTATE 
TRANSPORT OF FINE PM AND O3; FIPS TO REDUCE INTERSTATE TRANSPORT OF 
FINE PM & O3; REVISIONS TO CAIR RULE; REVISIONS TO ACID RAIN PROGRAM

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 7401 et seq


CFR Citation:


40 CFR 52


Legal Deadline:


Final, Statutory, November 18, 2004.


NPRM, Judicial, August 1, 2005, Proposed Determinations.


Other, Judicial, August 2, 2005, Must deliver to FR NLT 1 day after 
signature.


Final, Judicial, March 15, 2006, Final Determination.


Abstract:


This action includes two separate but related rulemakings to address 
interstate transport with respect to the 8-hour ozone and fine 
particulate matter (PM2.5) National Ambient Air Quality Standards. In 
one part, EPA is responding to a petition submitted to the Agency in 
March 2004, by the State of North Carolina pursuant to section

[[Page 64253]]

126 of the Clean Air Act. The petition requests that EPA make findings 
that emissions of nitrogen oxides (NOx) and sulfur dioxide (SO2) from 
large electric generating units (EGUs) in 12 States are significantly 
contributing to PM2.5 nonattainment or maintenance problems in North 
Carolina and that NOx emissions from large EGUs in 5 States are 
significantly contributing to 8-hour ozone nonattainment or maintenance 
problems in North Carolina. NOx and SO2 are precursors to PM2.5 
pollution; NOx is also a precursor to ozone pollution. If EPA makes 
such findings, EPA is authorized to establish Federal emissions limits 
for the affected sources. The second part of this rulemaking is related 
to EPA's Clean Air Interstate Rule (CAIR), promulgated on March 10, 
2005, which addresses interstate transport of NOx and SO2. CAIR 
requires 28 States and the District of Columbia to revise their State 
implementation plans (SIPs) to reduce emissions of NOx and/or SOx. 
Controlling these emissions will assist the downwind areas in meeting 
the PM2.5 and 8-hour ozone national ambient air quality standards. To 
act as a ``backstop'' for CAIR, EPA is also developing Federal 
implementation plans (FIPs) to address interstate transport. These FIPs 
are the second part of the two-part rulemaking we are discussing in 
this abstract. The FIPs would achieve the emissions reductions required 
under the CAIR if a State does not have an approved SIP to do so. In 
the FIP actions, EPA intends to propose Federal NOx and SO2 trading 
programs for electric generating units. The EPA is required to 
promulgate a FIP within 2 years of: 1) finding that a State has failed 
to make the required SIP submittal, 2) finding that the submittal 
received does not satisfy the minimum SIP completeness criteria, or 3) 
disapproving a SIP in whole or in part. The EPA is required to 
promulgate the FIP unless EPA has approved, within the 2-year time 
period, a SIP that corrects the identified deficiency. In an action 
published on April 25, 2005, EPA notified States that they had failed 
to submit SIPs to address transport that were due in 2000, 3 years 
after EPA established the 8-hour ozone and PM2.5 standards. This 
current rulemaking action is also proposing certain revisions to the 
CAIR and the Acid Rain Program.


Statement of Need:


Clean Air Act section 110(a)(2)(D) requires that each state's 
implementation plan include the ``good neighbor'' provisions of 
prohibiting sources in the State from emitting air pollutants in 
amounts that contribute significantly to nonattainment, or interfere 
with maintenance, of a national ambient air quality standard (NAAQS) in 
a downwind state. Under the Clean Air Interstate Rule (CAIR), EPA 
determined that emissions of nitrogen oxides (NOx) and/or sulfur 
dioxide (SO2) from 28 States and the District of Columbia are 
significantly contributing to nonattainment and/or maintenance problems 
in downwind States with respect to the PM2.5 and/or 8-hour ozone 
standards. Therefore, EPA established NOx and/or SO2 emissions 
reductions requirements for these States to mitigate the interstate 
transport. The Federal implementation plans (FIPs) for the CAIR would 
provide a backstop to ensure that the significant emissions reductions 
required by the CAIR would be achieved. On March 19, 2004, EPA received 
a petition from the State of North Carolina filed under section 126 of 
the CAA. The petition, which is based largely on the analyses for 
proposed CAIR, requests that EPA establish control requirements for 
electric generating units in 13 States based on findings that emissions 
of NOx and SO2 from these sources are significantly contributing to 
PM2.5 and/or 8-hour ozone nonattainment and maintenance problems in 
North Carolina.


Summary of Legal Basis:


In April 2005, EPA made national findings under CAA sections 
110(a)(2)(D) and 110(a)(1) that States have failed to submit SIPs 
required to address interstate transport with respect to the 8-hour 
ozone and PM2.5 NAAQS. The findings started a 2-year clock for EPA to 
promulgate FIPs to address the requirements of section 110(a)(2)(D). 
Section 126 allows States to petition EPA for a finding that major 
stationary sources or groups of sources in upwind States are 
significantly contributing to nonattainment or interfering with 
maintenance of a NAAQS in the petitioning State. If EPA makes the 
requested finding, EPA is authorized to establish emissions limitations 
for the affected sources. The EPA is required to respond to a section 
126 petition through notice-and-comment rulemaking by a specific 
deadline.


Alternatives:


The proposed Federal NOx and SO2 cap and trade programs for the section 
126 action and FIP would provide regulated sources with flexibility in 
their choice of compliance strategy. EPA is also proposing an 
abbreviated SIP option to allow States to submit SIPs to control 
specific elements of the Federal program. For the portion of the 
section 126 petition that has merit, EPA is proposing in the 
alternative to grant the petition or to deny the petition if EPA 
promulgates the FIP no later than the final section 126 response. In 
addition, EPA is proposing to withdraw section 126 or FIP control 
requirements in a State if the State submits and EPA approves a SIP 
that meets the requirements of CAIR.


Anticipated Cost and Benefits:


Costs and benefits for the proposal are based on the Regulatory Impact 
Analysis for the CAIR.


Risks:


The risks addressed are the health and welfare impacts resulting from 
nonattainment of the PM2.5 and 8-hour ozone NAAQS.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            08/24/05                    70 FR 49708
Final Action                    03/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 4956;


Agency Contact:
Carla Oldham
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 27711
Phone: 919 541-3347
Fax: 919 541-0824
Email: [email protected]

Joe Paisie
Environmental Protection Agency
Air and Radiation
C-504-02
Research Triangle Park, NC 27711
Phone: 919 541-5556
Fax: 919 541-5489
Email: [email protected]
RIN: 2060-AM99

[[Page 64254]]

_______________________________________________________________________



EPA



121.  REGIONAL HAZE REGULATIONS; REVISIONS TO PROVISIONS 
GOVERNING ALTERNATIVE TO SOURCE-SPECIFIC BEST AVAILABLE RETROFIT 
TECHNOLOGY (BART) DETERMINATIONS

Priority:


Other Significant


Legal Authority:


42 USC 7410; 2 USC 7414; 42 USC 7421; 42 USC 7470-7479


CFR Citation:


40 CFR 51.308(e)(2); 40 CFR 51.309; 40 CFR 51 Appendix Y (New)


Legal Deadline:


None


Abstract:


EPA published the regional haze rule on July 1, 1999 (64 FR 35714). On 
May 24, 2002, the D.C. Circuit Court vacated certain provisions of the 
regional haze rule related to best available retrofit technology 
(BART). The BART provisions at issue in that case were applicable on a 
source-by-source basis. The revisions to the haze rule to respond to 
that case are being finalized in the Clean Air Visibility Rule (CAVR) 
on June 15, 2005, under a consent decree. In a separate but related 
case, the D.C. Circuit vacated additional BART provisions in a decision 
issued on February 18, 2005. These provisions applied to BART in the 
context of optimal emissions trading programs. The program at issue in 
that case was the SO2 ``backstop'' emissions trading program developed 
by the Western Regional Air Partnership (WRAP), but the decision also 
controls all similar programs developed in the future. To address this 
decision, we proposed revisions to the haze provisions governing 
trading programs on August 1, 2005 (70 FR 44154). The proposal 
addresses both the particular circumstances of the WRAP and general 
implications of the decision for other programs. We intend to finalize 
this proposal by November 8, 2005, as noted in the CAVR consent decree.


Statement of Need:


This action is needed in response to the May 2002 ruling of the U.S. 
Court of Appeals for the D.C. Circuit (American Corn Growers et al. V. 
EPA, 291 F.3d 1) vacating the Best Available Retrofit Technology (BART) 
provisions of the regional haze rule. The Clean Air Act requires that 
States include BART in their visibility State Implementation Plans 
(SIPs). The Clean Air Act also requires that a State take steps to 
prevent emissions from sources located within its boundaries from 
interfering with a downwind State's ability to meet air quality 
standards, or interfering with measures to protect visibility.


Summary of Legal Basis:


Clean Air Act section 169A requires States to include BART in their 
visibility SIPs. Clean Air Act section 110(a)(2)(D) [42 USC 
7410(a)(2)(D)] requires that each State's implementation plan include 
the ``good neighbor'' provisions of prohibiting sources in the State 
from emitting air pollutants in amounts that contribute significantly 
to nonattainment in a downwind state, or interfere with measures to 
protect visibility in a Class I areas. Section 110(a)(1) [42 USC 
7410(a)(1)] requires States to submit implementation plans within a 
specified period of time after the promulgation of a new or revised 
national ambient air quality standard. In addition, EPA has authority 
under section 110(k)(5) [42 USC 7410(k)(5)] to require States to revise 
existing implementation plans whenever EPA finds that those plans are 
inadequate to comply with any requirement. Further, section 301(a)(1) 
[42 USC 7601(a)(1)] confers general authority upon the EPA 
Administrator. These provisions of the Clean Air Act confer authority 
on EPA to promulgate the present regulations.


Alternatives:


This entry comprises the action the Agency plans to take to implement 
the BART provisions of the Clean Air Act. This proposal addresses the 
elements we would expect an alternative trading program to contain in 
order to be approvable as an alternative to case-by-case BART.


Anticipated Cost and Benefits:


EPA prepared a regulatory impact analysis (RIA) for the proposed BART 
rule. Updated cost and benefit calculations were made for the final 
rulemaking.


Risks:


The risks addressed are the health and welfare impacts resulting from 
emissions that interfere with measures to protect visibility in Class I 
areas. These effects were outlined in detail in the Regulatory Impact 
Analysis for the proposed BART rulemaking.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            08/01/05                    70 FR 44154
Final Action                    11/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


San No. 4450-1. Split from RIN 2060-AJ31.


Agency Contact:
Kathy Kaufman
Environmental Protection Agency
Air and Radiation
C504-02
Research Triangle Park, NC 27711
Phone: 919 541-0102
Fax: 919 541-5489
Email: [email protected]

Todd Hawes
Environmental Protection Agency
Air and Radiation
C504-02
Research Triangle Park, NC 27711
Phone: 919 541-5591
Fax: 919 541-5489
Email: [email protected]
RIN: 2060-AN22
_______________________________________________________________________



EPA



122.  IMPLEMENTATION RULE FOR 8-HOUR OZONE NAAQS - PHASE 2

Priority:


Other Significant


Legal Authority:


42 USC 7410; 42 USC 7501-7511f; 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)

[[Page 64255]]

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:


EPA is developing this rule so that States may know which statutory 
requirements apply for purposes of developing State Implementation 
Plans (SIPs) under the Clean Air Act to implement the 8-hour ozone 
standard. After EPA had promulgated the 8-hour standard in 1997, EPA 
originally set forth an approach for implementation that was challenged 
in court. The Supreme Court ultimately ruled against EPA. This action 
addresses 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:


EPA proposed more prescriptive and less prescriptive options for 
several requirements of SIPs, such as the reasonably available control 
technology (RACT) requirement and the reasonable further progress (RFP) 
requirement. The final rulemaking will provide a decision on the 
options for these requirements.


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 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                            Date                        FR Cite

_______________________________________________________________________
NPRM Phase 1 & 2                06/20/03                    68 FR 32802
Final Action - Phase 2          10/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Local, State, Tribal


Additional Information:


SAN No. 4625.1; Split from RIN 2060-AJ99.


Agency Contact:
John Silvasi
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 27711
Phone: 919 541-5666
Fax: 919 541-0824
Email: [email protected]

Denise Gerth
Environmental Protection Agency
Air and Radiation
C539-02
Research Triangle Park, NC 27711
Phone: 919 541-5550
Fax: 919 541-0824
Email: [email protected]
RIN: 2060-AN23
_______________________________________________________________________



EPA



123. TEST RULE; TESTING OF CERTAIN HIGH PRODUCTION VOLUME (HPV) 
CHEMICALS

Priority:


Other Significant


Legal Authority:


15 USC 2603


CFR Citation:


40 CFR 790 to 799


Legal Deadline:


None


Abstract:


EPA is issuing test rules under section 4(a) of the Toxic Substances 
Control Act (TSCA) to require testing and recordkeeping requirements 
for certain high production volume (HPV) chemicals (i.e., chemicals 
which are manufactured (including imported) in the aggregate at more 
than 1 million pounds on an annual basis) that have not been sponsored 
under the voluntary HPV Challenge Program. Although varied based on 
specific data needs for the particular chemical, the data generally 
collected under these rules may include: Acute toxicity, repeat dose 
toxicity, developmental and reproductive toxicity, mutagenicity, 
ecotoxicity, and environmental fate. The first rule proposed testing 
for 37 HPV chemicals with substantial worker exposure. The number of 
chemicals included in the first final rule may be reduced based on new 
information on annual production volumes, worker exposure, and 
commitments to the voluntary HPV Challenge Program. Subsequent test 
rules will require similar screening level testing for other

[[Page 64256]]

unsponsored HPV Challenge Program chemicals.


Statement of Need:


EPA has found that, of those non-polymeric organic substances produced 
or imported in amounts equal to or greater than 1 million pounds per 
year based on 1990 reporting for EPA's Inventory Update Rule (IUR), 
only 7 percent have a full set of publicly available internationally 
recognized basic health and environmental fate/effects screening test 
data. Of the over 2,800 HPV chemicals based on 1990 data, 43 percent 
have no publicly available basic hazard data. For the remaining 
chemicals, limited amounts of the data are available. This lack of 
available hazard data compromises EPA's and others' ability to 
determine whether these HPV chemicals pose potential risks to human 
health or the environment, as well as the public's right-to-know about 
the hazards of chemicals that are found in their environment, their 
homes, their workplaces, and the products that they buy. It is EPA's 
intent to close this knowledge gap. EPA believes that for most of the 
HPV chemicals, insufficient data are readily available to reasonably 
determine or predict the effects on health or the environment from the 
manufacture (including importation), distribution in commerce, 
processing, use, or disposal of the chemicals, or any combination of 
these activities. EPA has concluded that a program to collect and, 
where needed, develop basic screening level toxicity data is necessary 
and appropriate to provide information in order to assess the potential 
hazards/risks that may be posed by exposure to HPV chemicals. On April 
21, 1998, a national initiative, known as the ``Chemical Right-To-
Know'' Initiative, was announced in order to empower citizens with 
knowledge about the most widespread chemicals in commerce-- chemicals 
that people may be exposed to in the places where they live, work, 
study, and play. A primary component of EPA's Chemical Right-To-Know 
(ChemRTK) initiative is the voluntary HPV Challenge Program, which was 
created in cooperation with industry, environmental groups, and other 
interested parties, and is designed to assemble basic screening level 
test data on the potential hazards of HPV chemicals while avoiding 
unnecessary or duplicative testing. Data needs which remain unmet in 
the voluntary HPV Challenge Program, may be addressed through the 
international efforts or rulemaking.


Summary of Legal Basis:


These test rules will be issued under section 4(a)(1)(B) of TSCA. 
Section 2(b)(1) of TSCA states that it is the policy of the United 
States that ``adequate data should be developed with respect to the 
effect of chemical substances and mixtures on health and the 
environment and that the development of such data should be the 
responsibility of those who manufacture [which is defined by statute to 
include import] and those who process such chemical substances and 
mixtures [.]'' To implement this policy, TSCA section 4(a) mandates 
that EPA require by rule that manufacturers and processors of chemical 
substances and mixtures conduct testing if the Administrator finds 
that: (1)(A)(i) The manufacture, distribution in commerce, processing, 
use, or disposal of a chemical substance or mixture, or that any 
combination of such activities, may present an unreasonable risk of 
injury to health or the environment, (ii) there are insufficient data 
and experience upon which the effects of such manufacture, distribution 
in commerce, processing, use, or disposal of such substance or mixture 
or of any combination of such activities on health or the environment 
can reasonably be determined or predicted, and (iii) testing of such 
substance or mixture with respect to such effects is necessary to 
develop such data; or (B)(i) a chemical substance or mixture is or will 
be produced in substantial quantities, and (I) it enters or may 
reasonably be anticipated to enter the environment in substantial 
quantities or (II) there is or may be significant or substantial human 
exposure to such substance or mixture, (ii) there are insufficient data 
and experience upon which the effects of the manufacture, distribution 
in commerce, processing, use, or disposal of such substance or mixture 
or of any combination of such activities on health or the environment 
can reasonably be determined or predicted, and (iii) testing of such 
substance or mixture with respect to such effects is necessary to 
develop such data.


Alternatives:


The strategy and overall approach that EPA is using to address data 
collection needs for U.S. HPV chemicals includes a voluntary component 
(the HPV Challenge Program), certain international efforts, and these 
rulemakings under TSCA. The issuance of a rulemaking is often the 
Agency's final mechanism for obtaining this important information.


Anticipated Cost and Benefits:


The potential benefits of these test rules are substantial, as no one 
-- whether in industry, government, or the public -- can make reasoned 
risk management decisions in the absence of reliable health and 
environmental information. The cost of the baseline screening testing 
that would be imposed is estimated to be about $200,000 per chemical 
for a full set of tests. It is unlikely, however, for a chemical to 
need a full set of tests, which would only occur if none of the data in 
question already exists.


Risks:


Data collected and/or developed under these test rules, 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.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/26/00                    65 FR 81658
Final Action                    01/00/06
NPRM2                           12/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


Federal


Additional Information:


SAN No. 3990;


Sectors Affected:


325 Chemical Manufacturing; 32411 Petroleum Refineries


URL For More Information:
www.epa.gov/opptintr/chemtest/sect4rule.htm

[[Page 64257]]

Agency Contact:
Catherine Roman
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202 564-8172
Fax: 202 564-4765
Email: [email protected]

Greg Schweer
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7405M
Washington, DC 20460
Phone: 202 564-8469
Fax: 202 564-4765
Email: [email protected]
RIN: 2070-AD16
_______________________________________________________________________



EPA



124. PESTICIDES; PROCEDURES FOR THE REGISTRATION REVIEW PROGRAM

Priority:


Other Significant


Legal Authority:


7 USC 136a(g); 7 USC 136w


CFR Citation:


40 CFR part 155


Legal Deadline:


None


Abstract:


The Agency will establish procedures to implement section 3(g) of the 
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) which 
provides for periodic review of pesticide registrations. The goal of 
these regulations, which are required by FIFRA section 3(g), is to 
review a pesticide's registration every 15 years. The regulations will 
address the following procedural aspects of the program: Establishing 
pesticide cases for registration review; establishing schedules; 
assembling information to be considered during the review; deciding on 
the scope and depth of the review; calling in data under FIFRA sec. 
3(c)(2)(B) that are needed to conduct the review; reviewing data and 
conducting risk assessments or benefit analyses, as needed; deciding 
whether a pesticide continues to meet the standard of registration in 
FIFRA; and public participation in the registration review process. If 
a pesticide does not meet the FIFRA standard, and cancellation is 
determined to be needed, the Agency will follow cancellation procedures 
in section 6 of FIFRA. This program will begin after the completion of 
tolerance reassessment in 2006 and before the completion of 
reregistration in 2008. Each pesticide will be reviewed every 15 years 
to assure that the it continues to meet the FIFRA standard for 
registration, including compliance with any new legislation, 
regulations or science policy.


Statement of Need:


The registration review procedural regulations are needed to implement 
the registration review program. This program will replace the 
reregistration and tolerance reassessment programs as the Agency's 
program for managing old chemicals. The tolerance reassessment program 
will end in August 2006 (statutory deadline) and the Agency expects to 
complete the last reregistration eligibility decision in September 
2008. The registration review program will provide for systematic and 
routine review of pesticides to assure, among other things, that the 
science supporting the decision to register the pesticide continues to 
meet current standards.


Summary of Legal Basis:


FIFRA 3(g) requires this procedural regulation.


Alternatives:


There are no non-regulatory options that would satisfy the requirements 
of FIFRA 3(g).


Anticipated Cost and Benefits:


The cost of the rule to industry is estimated to be $50 million 
annually. Annual per company cost is an average of less than $750K.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           04/26/00                    65 FR 24586
NPRM                            07/13/05                    70 FR 40251
Notice of Availability          08/17/05                    70 FR 48356
Final Action                    09/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses


Government Levels Affected:


Federal


Additional Information:


SAN No. 4170, EDocket No. OPP-2004-0404;


Sectors Affected:


32519 Other Basic Organic Chemical Manufacturing; 32551 Paint and 
Coating Manufacturing; 32532 Pesticide and Other Agricultural Chemical 
Manufacturing; 32561 Soap and Cleaning Compound Manufacturing


Agency Contact:
Vivian Prunier
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703 308-9341
Fax: 703 308-5884
Email: [email protected]

Jean Frane
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7506C
Washington, DC 20460
Phone: 703 305-5944
Fax: 703 305-5884
Email: [email protected]
RIN: 2070-AD29
_______________________________________________________________________



EPA



125. PESTICIDES; EMERGENCY EXEMPTION PROCESS REVISIONS

Priority:


Other Significant


Legal Authority:


7 USC 136p; 7 USC 136w


CFR Citation:


40 CFR 166


Legal Deadline:


None


Abstract:


EPA regulations under section 18 of the Federal Insecticide, Fungicide 
and Rodenticide Act (FIFRA) 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. This action will revise the regulations to improve the 
pesticide emergency exemption process. Two of these potential 
improvements are currently being tested through a limited pilot, and 
are based on recommendations from the States

[[Page 64258]]

which are the primary applicants for emergency exemptions. The proposed 
revisions would streamline the application and review process, thereby 
reducing the burden to applicants and EPA, while allowing for quicker 
emergency response without compromising existing protections for human 
health and the environment.


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 sec. 18 authorizes EPA to temporarily exempt States from the 
requirements of registration to alleviate an emergency condition.


Alternatives:


EPA has analyzed several measures for streamlining or improving the 
emergency exemption process, 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 adverse economic impact, options with varying 
cost do not apply.


Anticipated Cost and Benefits:


EPA has assessed the potential economic impacts of the proposed 
improvements and found that they would reduce burdens and costs to 
States and Federal agencies that apply for emergency exemptions, as 
well as reduce burden to EPA. The Agency estimates an annual cost 
reduction of $820,000 for applicants and $120,000 for EPA, for a total 
of $940,000. Indirect benefits may accrue to users of pesticides under 
emergency exemptions if changes result in faster review and approval, 
or greater availability of pesticides.


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                            Date                        FR Cite

_______________________________________________________________________
Notice: Limited Pilot           04/24/03                    68 FR 20145
NPRM                            09/03/04                    69 FR 53866
Final Action                    11/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4216, EDocket No. OPP-2004-0038;


Sectors Affected:


9241 Administration of Environmental Quality Programs


URL For More Information:
http://www.epa.gov/opprd001/section18/

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
Fax: 703 305-5884
Email: [email protected]
RIN: 2070-AD36
_______________________________________________________________________



EPA



126. PROTECTIONS FOR TEST SUBJECTS IN HUMAN RESEARCH

Priority:


Other Significant


Legal Authority:


5 USC 301; 7 USC 136w(a)(1); 21 USC 346a(e)(1)(C); 42 USC 300v-1(b)


CFR Citation:


40 CFR 26


Legal Deadline:


Final, Statutory, January 29, 2006, HR 2361, Department of Interior, 
Environment, and Related Agencies Appropriations Act of 2006, 08/02/05.


Abstract:


In early September 2005, EPA proposed a rulemaking to ban intentional 
dosing human testing for pesticides when the subjects are pregnant 
women or children, to formalize and further strengthen existing 
protections for subjects in human research conducted or supported by 
EPA, and to extend new protections to adult subjects in intentional 
dosing human studies for pesticides conducted by others who intend to 
submit the research to EPA. This proposal, the first of several 
possible Agency actions, focuses on third-party intentional dosing 
human studies for pesticides, but invites public comment on alternative 
approaches with broader scope. This proposed rule would significantly 
strengthen the ethical framework for conducting and reviewing human 
studies, especially intentional dosing human studies for pesticides. 
With respect to human research conducted by EPA (``first-party 
research''), or by others with EPA's support (``second-party 
research''), this proposed rule would (1) categorically prohibit any 
intentional dosing studies involving pregnant women or children as 
subjects; and (2) adopt the Department of Health and Human Services 
(HHS) regulations that provide additional protections to pregnant women 
and children as subjects of other than intentional dosing studies. With 
respect to human research conducted by third-parties--i.e., by others 
without any support from EPA or other Federal Government agencies--the 
proposed rule would: (1) Categorically prohibit any third-party 
intentional dosing studies for pesticides involving pregnant women or 
children as subjects; (2) extend the provisions of the Federal Policy 
for the Protection of Human Subjects of Research (the ``Common Rule'') 
to all other third-party intentional dosing human studies intended for 
submission to EPA under the pesticide laws; (3) require, before testing 
is initiated, submission to EPA of protocols and related information 
for proposed research covered by this extension of the Common Rule; and 
(4) require information about the ethical conduct of covered human 
studies when the results of the research are submitted to EPA. In 
addition, the proposed rule would (1) establish an independent Human 
Studies Review Board to review proposals for covered

[[Page 64259]]

intentional dosing human research and reports of completed research; 
(2) specify measures EPA would consider to address non-compliance with 
the provisions of a final rule along the lines of this proposal; (3) 
define the ethical standards EPA would apply in deciding whether to 
rely on relevant, scientifically sound data derived from intentional 
dosing human studies for pesticides, and (4) forbid EPA to rely in its 
decision-making under the pesticide laws on human research involving 
intentional exposure of pregnant women or children. The pace of rule 
development has accelerated in response to the FY 2006 Appropriations 
Act, signed by the President on August 2, 2005, which requires the 
Agency to promulgate a final rule within 180 days of enactment, or by 
January 29, 2006.


Statement of Need:


In July 1998, the Agency stated that it had not used any human study 
data for final decisions under the FQPA. The Agency subsequently 
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 without reaching 
consensus on many issues. In December 2001 the Agency sought the advice 
of the National Academy of Sciences on remaining scientific and ethical 
issues. At the same time, the Agency issued an interim policy, 
committing, subject to certain exceptions, not to consider or rely on 
any third party studies involving intentional dosing of human 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. The Agency's interim policy 
was challenged in a lawsuit filed in early 2002. In May 2003 the Agency 
published an Advance Notice of Proposed Rulemaking on the subject of 
the acceptability of human studies, posing an array of questions in 
response to which many comments and suggestions were received. The ANPR 
also restated the Agency's intention to issue proposed rules for 
comment. In June 2003, the U.S. Court of Appeals vacated the December 
2001 interim policy on the ground that it constituted an improperly 
promulgated ``rule.'' The Court further stated that, as a consequence, 
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.`` In 
February 2004, the NAS released their report, making many 
recommendations now under review by the Agency. Some of the Academy's 
recommendations could only be implemented through rulemaking. On August 
2, 2005, the President signed into law Pub. L. 109-54, the Department 
of Interior, Environment, and Related Agencies Appropriations Act, 
2006, which provides appropriated funds for the Environmental 
Protection Agency and other Federal departments and agencies. Section 
201 addresses EPA activities regarding third-party intentional dosing 
human toxicity studies using pesticides. Specifically, Section 201 
provides: ``None of the funds made available by this Act may be used by 
the Administrator of the Environmental Protection Agency to accept, 
consider or rely on third-party intentional dosing human toxicity 
studies for pesticides, or to conduct intentional dosing human toxicity 
studies for pesticides until the Administrator issues a final 
rulemaking on this subject. The Administrator shall allow for a period 
of not less than 90 days for public comment on the Agency's proposed 
rule before issuing a final rule. Such rule shall not permit the use of 
pregnant women, infants or children as subjects; shall be consistent 
with the principles proposed in the 2004 report of the National Academy 
of Sciences on intentional human dosing and the principles of the 
Nuremberg Code with respect to human experimentation; and shall 
establish an independent Human Subjects Review Board. The final rule 
shall be issued no later than 180 days after enactment of this Act.``


Summary of Legal Basis:


With respect to pesticides, the Federal Insecticide, Fungicide and 
Rodenticide Act (7 U.S.C 136 et seq.), a licensing statute, requires 
applicants for registration to provide a ``full description of tests 
made and the results thereof'' and further authorizes EPA to call in 
data to maintain a registration under FIFRA sec. 3(c)(2)(B). FIFRA sec. 
25(a) provides general rulemaking authority to implement these data 
requirements, and also to interpret FIFRA sec. 12(a)(2)(P), which makes 
it unlawful to conduct tests using human subjects unless the subjects 
volunteer for such tests and are fully informed. Section 408(e) of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 346a) authorizes the 
Administrator to issue regulations establishing general procedures and 
requirements. EPA has broad authority under 5 U.S.C. 301 and 42 U.S.C. 
300v-1(b).


Alternatives:


Although several options were considered over the years, it is 
important to note that the FY 2006 Appropriations Act, signed by the 
President on August 2, 2005, specifically directs the Agency to 
promulgate a rule to address third party intentional dosing human 
toxicity studies for pesticides. In the Economic Analysis that was 
prepared for the proposed rule, EPA identified a range of options for 
which potential impacts have been evaluated and presented. The first 
option involved continuing current practice, but this option is not 
viable given the recent congressional mandate to promulgate a rule. The 
second option would extend the requirements of the Common Rule to 
third-party human research only when it involved intentional exposure 
studies for the purpose of identifying or quantifying a toxic effect. 
The third option would extend the requirements of the Common Rule to 
all third-party intentional exposure human studies intended for 
submission under FIFRA or FFDCA, and the fourth option would extend the 
requirements of the Common Rule to all third-party human research 
intended for submission under the pesticide laws. All of the latter 
three options include a requirement on third parties to submit 
protocols for review prior to initiating the types of human research 
covered by the Common Rule. Finally, options 2 - 4 include a provision 
prohibiting the Agency and third parties from conducting covered human 
research with pregnant women or children as subjects.


Anticipated Cost and Benefits:


The Agency has conducted a preliminary analysis of the benefits of a 
proposed rulemaking in qualitative terms. These benefits included 
greater protections for test subjects, and a corresponding reduction in 
their risks, to the extent that affected researchers are not already 
following the Common Rule. The general public will benefit from the 
proposed rule because the rule will strengthen the protections for 
human subjects and reinforce the Agency's strong commitment to base its 
decisions on scientifically sound information. The benefits to sponsors 
of third-party human research include a better understanding of the 
standards

[[Page 64260]]

that EPA will apply in determining whether to rely on the results of 
their studies, and thus, the opportunity to design and perform studies 
that are more likely to meet EPA standards, leading to more efficient 
Agency reviews. The preliminary analysis also estimates the potential 
costs of the proposed rule to third parties and to EPA for implementing 
the new requirements. In general, EPA believes that most, if not all, 
third-party research intended for submission to EPA that involves 
intentional exposure of human subjects already complies with the Common 
Rule or an equivalent international standard. For purposes of this 
analysis, EPA assumed that current practice was in full compliance with 
the Common Rule. In contrast, EPA assumed that other types of third-
party human research do not comply with the Common Rule, although it is 
likely that many responsible for such research are aware of and do 
follow Common Rule principles relating to informed consent and IRB 
review. After reviewing the history of EPA's consideration of research 
involving human subjects in its various program offices, EPA estimates 
that the proposed rule would affect only a limited number of third-
party studies involving human subjects each year. EPA also collected 
data on the cost per study of compliance with the Common Rule. These 
costs include preparing documents to support review by an IRB and the 
expense associated with the IRB review. These costs are very minor 
relative to the overall cost of conducting the studies. For EPA, the 
costs are associated with the review of protocols and the review of 
completed human studies to determine whether they complied with the 
Common Rule. For all of the options, the potential costs of the 
proposed rule to third party researchers and EPA are estimated to be 
very low, both because the number of affected studies is relatively 
small and because the costs of compliance with the Common Rule are low. 
Where the option simply reflects the current practice (option 1) the 
added total incremental costs to third-party sponsors of human research 
are zero. EPA assumes that currently the pesticide industry is already 
spending $159,000 to $196,000 annually to comply with the Common Rule 
for intentional exposure human studies and the Agency is currently 
spending $113,000 a year to review, on a case-by-case basis, the 
ethical aspects of such studies. Option 2 would add an estimated total 
annual incremental cost to third parties of $7,532, and an estimated 
annual cost to EPA of $220,894. Option 3 would add an estimated total 
annual incremental cost to third parties of $16,140, and an estimated 
annual cost to EPA of $327,630. Option 4 would add an estimated total 
annual incremental cost to third parties of $202,700 to $242,796, and 
an estimated annual cost to EPA of $601,134. The proposed rule, if 
finalized as proposed, is estimated to result in a total annual 
incremental cost to third parties of approximately $16,000, and an 
estimated annual cost to EPA of approximately $328,000.


Risks:


To the extent that affected researchers are not already following the 
Common Rule, this rulemaking will provide greater protections for test 
subjects, and thereby provide a corresponding reduction in potential 
risks to these individuals.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           05/07/03                    68 FR 24410
Notice                          02/08/05                     70 FR 6661
NPRM                            09/12/05                    70 FR 53838
Final Action                    01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Organizations


Government Levels Affected:


Federal


Additional Information:


SAN No. 4610, EDocket No. OPP-2003-0132;


Sectors Affected:


32532 Pesticide and Other Agricultural Chemical Manufacturing


URL For More Information:
www.epa.gov/oppfead1/guidance/human-test.htm

Agency Contact:
William Jordan
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
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: 703 308-4776
Email: [email protected]
RIN: 2070-AD57
_______________________________________________________________________



EPA



127. RCRA BURDEN REDUCTION INITIATIVE

Priority:


Other Significant


Legal Authority:


42 USC 6907; 42 USC 6912(a); 42 USC 6921; 42 USC 6922; 42 USC 6923; 42 
USC 6924; 42 USC 6925; 42 USC 6926; 42 USC 6927; 42 USC 6930; 42 USC 
6934; 42 USC 6935; 42 USC 6937; 42 USC 6938; 42 USC 6939; 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 Government-wide 
goal established by the Paperwork Reduction Act (PRA). In June 1999, 
EPA published a Notice of Data Availability (NODA) in the Federal 
Register (64 FR 32859) to seek comment on a number of burden reduction 
ideas to eliminate duplicative and nonessential paperwork. After 
reviewing the comments received on the NODA, EPA proposed (67 FR 2518,

[[Page 64261]]

1/17/02) to implement many of these ideas. EPA issued a notice (68 FR 
61662; 10/29/03) seeking further input on a number of changes we 
proposed. EPA plans to finalize this burden reduction effort.


Statement of Need:


The Paperwork Reduction Act of 1995 establishes a Federal Government-
wide goal to reduce the paperwork and reporting burden it imposes. The 
RCRA Burden Reduction Initiative Proposed Rulemaking makes the 
regulatory changes necessary to meet this goal.


Summary of Legal Basis:


This action is not required by statute or court order.


Alternatives:


Reducing recordkeeping and reporting will require changes in our 
regulations. There was no alternative to doing a rulemaking. The Agency 
sought opinions from the regulated community on various burden 
reduction possibilities.


Anticipated Cost and Benefits:


Our preliminary cost benefit analyses for the final rule shows a 
savings of between 38,800 and 54,000 burden hours. The total annual 
cost savings under the final rule ranges from approximately $3.1 
million to $4 million. The rule will have minimal impact on the 
protectiveness of the RCRA regulations. It will eliminate or streamline 
paperwork requirements that are unnecessary.


Risks:


The rule will have no risk impacts.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NODA 1                          06/18/99                    64 FR 32859
NPRM                            01/17/02                     67 FR 2518
NODA 2                          10/29/03                    68 FR 61662
Final Action                    11/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State, Local, Tribal


Additional Information:


SAN No. 4084; Applicable SIC codes: Chemicals and Allied Products (28), 
Primary Metal Industries (33), Fabricated Metals (34), Industrial 
Machinery and Equipment (35), Electrical Equipment (36), Transportation 
Equipment (37), Other Manufacturing, Transportation and Utilities (40-
49), Wholesale Trade (50-51), Services (70-89) and Other SIC Groups


Sectors Affected:


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:
Elaine Eby
Environmental Protection Agency
Solid Waste and Emergency Response
5302W
Washington, DC 20460
Phone: 703 308-8449
Fax: 703 308-8433
Email: [email protected]
RIN: 2050-AE50
_______________________________________________________________________



EPA



128. REVISIONS TO THE DEFINITION OF SOLID WASTE

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 6903 ``RCRA Section 1004''


CFR Citation:


40 CFR 261.2


Legal Deadline:


None


Abstract:


Under RCRA, to be a hazardous waste, a material must also be a solid 
waste. EPA's framework for determining whether a material is a solid 
waste is based on what the material is, and how it's managed (e.g., how 
it is used, reused, etc.). For materials being recycled, RCRA 
jurisdiction is complex and the history of legal decisions related to 
the definition of solid waste is extensive. Primarily, in response to 
American Mining Congress v. EPA, 824 F. 2d 1177(D.C. Cir. 1987) (``AMC 
I'') and one of the most recent decisions, the Association of Battery 
Recyclers v. EPA 208 F.3d 1047 (2000) (``ABR''), EPA has proposed to 
revise the definition of solid waste. We specifically address materials 
undergoing reclamation. In the context of reclamation, we discuss 
options for how to identify materials that remain in use in a 
continuous process in the generating industry and thus are not solid 
wastes. In addition, we proposed criteria for determining whether or 
not hazardous secondary materials are recycled legitimately.


Statement of Need:


EPA is revising the definition of solid waste to increase recycling and 
as a response to several court decisions.


Summary of Legal Basis:


Association of Battery Recyclers v. EPA, 203 F. 2d 1047 (D.C. Cir. 
2000); American Mining Congress v. EPA, 824 F. 2d 1177 (D.C. Cir. 1987) 
and other cases


Alternatives:


We have solicited comment in the proposal on several alternative 
regulatory options, including a broad exclusion for legitimately 
recycled materials, and are currently evaluating public comments on all 
available options.


Anticipated Cost and Benefits:


We expect that this rule will increase the recycling of wastes covered 
by the rule. We have prepared an economic analysis for the proposed 
rule, and we are presently developing preliminary costs and benefits 
for all our regulatory options. When an option is chosen and a final 
rule is drafted, we will prepare a detailed economic analysis 
quantifying the costs and benefits.


Risks:


We are developing conditions for the final rule so that there will be 
no negative impacts on human health and the environment.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/28/03                    68 FR 61558
Final Action                    11/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, State


Additional Information:


SAN No. 4670; Listed in the 2005 OMB report, Regulatory Reform of the 
U.S. Manufacturing Sector. EPA and OMB

[[Page 64262]]

have determined that this reform has potential merit and justifies 
further action.


Agency Contact:
Marilyn Goode
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8800
Fax: 703 308-0514
Email: [email protected]

Tracy Atagi
Environmental Protection Agency
Solid Waste and Emergency Response
5304W
Washington, DC 20460
Phone: 703 308-8672
Fax: 703 308-0514
Email: [email protected]
RIN: 2050-AE98
_______________________________________________________________________



EPA



129. NATIONAL PRIMARY DRINKING WATER REGULATIONS: GROUND WATER RULE

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


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


Legal Authority:


42 USC 300 g-1 ``SDWA 1412 (b)(8)''; 42 USC 300j-4 ``SDWA 1445''


CFR Citation:


40 CFR 141; 40 CFR 142


Legal Deadline:


Other, Statutory, Not later than promulgation of the Stage 2 
Disinfection Byproducts Rule (currently scheduled for December 2005).


Abstract:


EPA proposed a targeted risk-based regulatory strategy for all public 
water systems served by ground water in May of 2000. The proposed 
requirements provide a meaningful opportunity to reduce public health 
risk for a significant number of people served by ground water sources 
from the exposure to waterborne pathogens from fecal contamination. 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. The final rule will establish a 
risk-based strategy as was described in the proposed (May 2000) 
rulemaking. However, the proposed design has been improved in the draft 
final rule to provide greater flexibility for States and systems 
implementing the rule.


Statement of Need:


Public water systems (PWSs) that use ground water as their sole source 
of water, as opposed to surface water PWSs, are not federally regulated 
as to treatment for microorganisms. There is data that indicates that a 
number of ground water PWSs are contaminated with microorganisms of 
fecal origin that can and have caused illness.


Summary of Legal Basis:


Section 1412(b)(8) of the Safe Drinking Water Act requires that EPA 
develop regulations specifying the use of disinfectants for ground 
water systems as necessary and ``. . .(as part of the regulations) 
promulgate criteria. . .to determine whether disinfection shall be 
required as a treatment technique for any public water system served by 
ground water.''


Alternatives:


EPA considered four regulatory alternatives in the development of the 
GWR proposal: The proposed regulatory alternative (multi-barrier 
option), the sanitary survey option, the sanitary survey and triggered 
monitoring option, and the across-the-board disinfection option. All 
options include the sanitary survey provision. The sanitary survey 
option would require the primary agency to perform surveys every 3 to 5 
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 options adds a source water fecal indicator 
monitoring requirement triggered by a total coliform positive sample in 
the distribution system. The multi-barrier option, which was proposed 
by EPA, adds a hydrogeologic sensitivity assessment to these elements 
which, if a system is found to be sensitive, results in a routine 
source water fecal indicator monitoring requirement. The multi-barrier 
option and the sanitary survey and triggered monitoring options are 
targeted regulatory approaches designed to identify wells that are 
fecally contaminated or are at a high risk for contamination. These 
across-the-board disinfection options 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% 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 ground 
water systems. Children, the elderly and the immunocompromised are 
particularly sensitive to the waterborne pathogens and account for 
between 20 and 30 percent of the illnesses and deaths. As

[[Page 64263]]

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), the 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            05/10/00                    65 FR 30194
Final Action                    04/00/06

Regulatory Flexibility Analysis Required:


Yes


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, Local, State, Tribal


Additional Information:


SAN No. 2340; Statutory deadline for final rule: Not later than the 
Administrator promulgates a Stage II rulemaking for disinfection 
byproducts (currently scheduled for July 2005).


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



130. 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, specifically cryptosporidium, 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 previously available. 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 microbes, to determine effective regulatory 
requirements for controlling microbial risk. On March 30, 1999, EPA 
established a committee of stakeholders under the Federal Advisory 
Committee Act (FACA) to assist in the development of these rules; 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 has 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 authorizes 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

[[Page 64264]]

reduction. Although the 1996 Amendments do not require EPA to finalize 
a Long Term 2 Enhanced Surface Water Treatment Rule ``concurrently 
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%) 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            08/11/03                    68 FR 47639
Final Action                    12/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 4341;


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Sean Conley
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202 564-1781
Fax: 202 564-3767
Email: [email protected]

Dan Schmelling
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202 564-5281
Fax: 202 564-3767
Email: [email protected]
RIN: 2040-AD37
_______________________________________________________________________



EPA



131. NATIONAL PRIMARY DRINKING WATER REGULATIONS: STAGE 2 DISINFECTION 
BYPRODUCTS RULE

Priority:


Economically Significant. Major under 5 USC 801.


Unfunded Mandates:


This action may affect State, local or tribal 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 141-142; 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 non-transient non-community 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 previously available. 
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

[[Page 64265]]

(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 
concurrently 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            08/18/03                    68 FR 49548
Final Action                    12/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses, Governmental Jurisdictions, Organizations


Government Levels Affected:


Federal, State, Local, Tribal


Federalism:


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


Additional Information:


SAN No. 4342;


Sectors Affected:


22131 Water Supply and Irrigation Systems


Agency Contact:
Tom Grubbs
Environmental Protection Agency
Water
4607
Washington, DC 20460
Phone: 202 564-5262
Fax: 202 564-3767
Email: [email protected]

Stig Regli
Environmental Protection Agency
Water
4607M
Washington, DC 20460
Phone: 202 564-5270
Fax: 202 564-3767
Email: [email protected]
RIN: 2040-AD38
BILLING CODE 6560-50-S

[[Page 64266]]




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 item in this Regulatory Plan involves 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 is intended to 
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. On February 
4, 2005, AARP sued the EEOC seeking to prevent issuance of the final 
rule.
_______________________________________________________________________



EEOC

                              -----------

                            FINAL RULE STAGE

                              -----------




132. 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 considered 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                            Date                        FR Cite

_______________________________________________________________________
NPRM                            07/14/03                    68 FR 41542
NPRM Comment Period End         09/12/03
Next Action Undetermined        01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal, Local, State


Additional Information:


On February 4, 2005, AARP sued the EEOC seeking to prevent issuance of 
the final rule.

[[Page 64267]]

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 64268]]




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 2006 regulatory priority is to complete conversion 
of the Federal Property Management Regulations to the Federal 
Management Regulation (FMR).
 GSA is writing the FMR so that its contents are consistent and 
sensible, and limit the regulatory burden placed on Government 
officials and the public. GSA has adopted a question and answer, plain 
language format for its regulations to make them easier to read and 
understand. 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.
BILLING CODE 6820-27-S

[[Page 64269]]




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 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 was created to pursue activities in space devoted to peaceful 
purposes and the benefit of all humankind. Our mission isto explore, 
discover, and understand the Earth's origins and the phenomena in the 
atmosphere and space that affect life. We are pursuing a Vision for 
Space Explorationthat will advance U.S. scientific, security, and 
economic interests through a robust robotic and human space exploration 
program that will take us throughout the solar system and beyond. We 
will redefine what is``possible,'' and develop innovative technologies 
to protect our planet and improve human life. We will promote 
international and commercial partnerships to further science, security, 
and safety. And, we will lead the world into a new understanding of our 
planet, our solar system, and the universe around us.
 The following are narrative descriptions of the most important 
regulations being planned for publication in the Federal Register 
during fiscal year (FY) 2006.
 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 2006, except to conform to FAR changes that are promulgated. In a 
continuing effort to keep the NFS current with NASA initiatives and 
Federal procurement policy, minor revisions to the NFS will be 
published.
 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 7510-13-S

[[Page 64270]]




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 2006. The first, 
included in The Regulatory Plan, is to revise and update our records 
management regulations in 36 CFR ch. XII, subchapter B. This regulatory 
activity is part of a major NARA initiative to review and redesign our 
records management program that started in 2000. We began work on this 
priority in fiscal year 2004 with a proposal for a new organizational 
framework for the records management regulations to make them easier to 
use. In fiscal year 2005, we issued a regulation relating to transitory 
e-mail in advance of the overall subchapter B revision. We will issue 
the proposed rule to revise subchapter B in 2006.
The second priority is to revise our records declassification 
regulation in 36 CFR part 1260 to reflect changes in the Executive 
Order governing declassification of national security classified 
information (E.O. 12958, as amended, Classified National Security 
Information). Our regulations in part 1260 establish procedures for the 
automatic declassification of records in NARA's legal custody and 
revise requirements for reclassification of information as provided for 
in the Executive Order. NARA serves the public and Federal agencies by 
specifying the declassification process we use.
Our third priority regulatory action is reviewing and updating our 
NHPRC grants program regulations in 36 CFR part 1206. The NHPRC grants 
program participates in the Grants.gov eGovernment Initiative, and our 
review will ensure that the regulations reflect that participation. The 
NHPRC makes grants to preserve and to deliver historical records for 
use by the American people. The Commission each year receives over 150 
applications requesting over $15 million of which less than $10 million 
is available to award.
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 completed a revised regulation specifying facility standards for 
records storage facilities that house Federal records(RIN 3095-AB31) in 
fiscal year 2005.
_______________________________________________________________________



NARA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




133. 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 revising its records management regulations in 36 CFR ch. XII, 
subchapter B to ensure that the regulations are appropriate, effective, 
and clear. During fiscal year 2006, we will publish several rules 
relating to the redesign.


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 is 
designed to furnish the information necessary to protect the legal and 
financial rights of the Government and of persons directly affected by 
the agency's activities (44 U.S.C. 3101). Agency heads must also have 
an active, continuing records management program (44 U.S.C. 3102).


Alternatives:


None.


Anticipated Cost and Benefits:


The revision of NARA's records disposition policies and processes, of 
which this regulation review is a part, is intended to reduce the 
burden on agencies and NARA in the area of records disposition 
activities.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Begin Review                    09/17/02
ANPRM                           03/15/04                    69 FR 12100
ANPRM Comment Period End        05/14/04
NPRM                            11/00/05

[[Page 64271]]

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


URL For More Information:
www.archives.gov/records-mgmt/initiatives/rm-redesign-project.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: 301 837-1477
Fax: 301 837-0319
Email: [email protected]
Related RIN: Related to 3095-AB05, Related to 3095-AB41, Related to 
3095-AB43, Related to 3095-AB39
RIN: 3095-AB16
BILLING CODE 7515-01-S

[[Page 64272]]




OFFICE OF PERSONNEL MANAGEMENT (OPM)



Statement of Regulatory Priorities
The Office of Personnel Management (OPM) is the human resources 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 human resources 
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 
human resources management that will enable the Federal Government to 
recruit, manage, develop, 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 continue implementing this initiative 
by way of collaboration, coordination, and regulation as necessary and 
appropriate during the coming year.
National Security Personnel System
The 2004 National Defense Authorization Act (NDAA) authorizes the 
creation of a National Security Personnel System (NSPS) at the 
Department of Defense (DoD). OPM has collaborated extensively with DoD 
to identify the regulatory requirements needed to establish a flexible 
and contemporary human resources management system as called for in the 
statute. The NSPS must be fair and credible, adhere to merit 
principles, honor veterans' preference, protect against prohibited 
personnel practices, and include a performance management system that 
incorporates pay for performance. In addition, the Act permits the 
establishment of a new labor relations system and a new employee 
appeals process, and grants flexibilities in recruitment and assignment 
actions and in the adjustment of overall agency staff. The NSPS is 
vital to DoD's national security mission and will remain a regulatory 
priority for OPM in the year ahead.
Working for America Act (WFAA)
OPM and OMB have drafted legislation that they anticipate will be 
introduced in Congress sometime in the fall of 2005. This legislation 
will modernize certain elements of existing civil service law covering 
Federal employees in departments and agencies not covered by statutes 
already enacted for the Departments of Defense and Homeland Security. 
If enacted, over the course of the next year OPM would begin to develop 
regulations to define in greater detail the parameters of these new 
statutory authorities(i.e., for the governmentwide classification, pay, 
and performance appraisal systems, as well as for any other new human 
resources authorities enacted into law) and to provide a plan for 
fairly and effectively implementing new human resources management 
authorities through a system of robust coordination, certification, 
oversight, and evaluation.
Compensation Reform
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 2006, including the final regulations 
on recruitment, relocation, and retention incentives; compensatory time 
for travel; annual leave accrual for SES members; and annual leave 
creditable service enhancements.
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). These initiatives will require promulgation of new or modified 
regulations. In addition, OPM has been designated the managing partner 
of the Human Resources Line of Business (HR LOB). The objective of HR 
LOB is to create a framework for a Governmentwide, modern, cost 
effective, standardized, and interoperable Human Resources solution 
that provides common core functionality and maximizes automation of 
processes to support the strategic management of human capital. The 
current suite of e-Government initiatives managed by OPM will be 
transitioned and integrated into the HR LOB. This initiative will also 
require promulgation of new or modified regulations in 2005-2006.
No FEAR Regulations
In July 2003, 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 Treasury 
Department's judgment fund, notice and training for applicants and 
employees, and reporting requirements by agencies. Regulations 
concerning reimbursement of the judgment fund were promulgated on an 
interim final basis on January 22, 2004. Regulations concerning notice 
and training for applicants and employees were promulgated as proposed 
regulations on February 28, 2005. At the request of Congress and 
stakeholder groups, the comment period for the regulations was extended 
from April 2005 to June 2005. After working with the EEOC, the Office 
of Special Counsel, the Department of Justice and the Department of 
Treasury, OPM expects to promulgate the remaining provisions of title 
II of the Act, the regulations for the annual report and comprehensive 
study before the end of this calendar year.
Human Resources (HR) Flexibilities
In FY 2005 OPM continued to modernize the civil service and hiring 
process. OPM issued the following proposed and interim regulations in 
support of this endeavor which we anticipate will be finalized in FY 
2006. The Direct Hire for Acquisition Positions regulation will allow 
non-DoD agencies to recruit and directly hire individuals into certain 
Federal acquisition positions.The Employment of Persons with 
Disabilities regulation supports the President's New Freedom Initiative 
and will provide agencies the authority to determine whether these 
individuals can receive an excepted appointment. The Student Career 
Experience Program regulations enhance the value of work experience and 
academic performance as credits towards a permanent appointment. The 
Veterans Recruitment Appointment regulations broaden eligibility 
criteria for obtaining a noncompetitive appointment. The salary offset 
(dual compensation) waivers regulation amends the criteria under which 
OPM may grant dual compensation (salary off-set) waivers on a case-by-
case basis, or delegate waiver authority to agencies in emergency 
situations posing a direct

[[Page 64273]]

threat to life or property or in unusual non-emergency situations.
Human Capital Management
The Chief Human Capital Officers Act established a new chapter 14, 
Agency Chief Human Capital Officers, within title 5, U.S. Code, as well 
as a requirement for OPM to establish by regulation systems for 
assessing the management of human capital in Federal agencies. 
Provisions of the NDAA established a related requirement for agencies 
to conduct annual employee surveys under regulations issued by OPM. In 
the coming year, OPM will be addressing these and related general human 
capital management requirements through implementing regulations.
Combined Federal Campaign (CFC)
OPM is in the process of issuing a proposed regulation for the Combined 
Federal Campaign (CFC) which will require all CFC applicant charities 
to certify that they are in compliance with all statutes, executive 
orders, and regulations restricting or prohibiting U.S. persons and 
entities from engaging in transactions and dealings with countries, 
entities, or individuals subject to economic sanctions administered by 
the U.S. In addition, OPM is exploring other possible regulatory 
changes concerning participation criteria.
BILLING CODE 6325-44-S

[[Page 64274]]




PENSION BENEFIT GUARANTY CORPORATION (PBGC)



Statement of Regulatory and Deregulatory Priorities
The Pension Benefit Guaranty Corporation (PBGC) protects the pensions 
of over 44 million working men and women in about 31,000 private 
defined benefit 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. The PBGC regulatory priorities are focused on 
improving transparency and increasing the use of electronic filing to 
simplify filing.
PBGC Insurance Programs
The 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.
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 
2004, the program had a record $23 billion deficit, and Congress was 
considering proposals by the Administration and others to improve 
funding of plans and restore the financial health of the insurance 
program.
Multiemployer Program.The smaller multiemployer program covers 1,600 
collectively bargained plans involving more than one unrelated 
employer. The PBGC provides financial assistance (in the form of a 
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. The multiemployer program, which is separately 
funded from the single-employer program, went into a deficit position 
in FY 2003, which improved slightly in 2004. The Administration will be 
examining the multiemployer program to determine what changes, if any, 
may be needed to strengthen it.
Regulatory Objectives and Priorities
PBGC regulatory objectives and priorities are developed in the context 
of its statutory purposes: (1) encouraging voluntary private pension 
plans; (2) providing for the timely and uninterrupted payment of 
pension benefits; and (3) keeping premiums at the lowest possible 
levels. PBGC also attempts to minimize administrative burdens on plans 
and participants.
The PBGC regulatory priorities are focused on changes to improve 
transparency and to simplify filing with PBGC by increasing use of 
electronic filing. PBGC policymaking gives consideration to the special 
needs and concerns of small business.
Improve Transparency of Information
PBGC has been moving forward to improve transparency of information to 
plan participants, investors, and PBGC, to better inform them and to 
encourage more responsible funding of pension plans. In March 2005, 
PBGC issued a final rule requiring the filing of certain additional 
items of supporting information for plan actuarial information and 
employer financial information that is required of certain employers 
with large amounts of pension underfunding. PBGC also is developing 
proposed amendments to the regulation that requires notice to PBGC of 
certain events that threaten plan funding. In addition, PBGC is 
developing proposed amendments to improve the accuracy of plan funding 
information that certain underfunded plans are required to provide in 
an annual Participant Notice.
Simplify Filing by Increasing Use of Electronic Filing
The PBGC introduced optional electronic filing of premiums in 2004 with 
an online filing system that employs PBGC software. In March 2005, PBGC 
issued a proposed rule that would require electronic filing of premium 
information for plans with 500 or more participants for plan years 
beginning after 2005 and for all plans for plan years beginning after 
2006. The PBGC would grant case-by-case exemptions for filers that 
demonstrated good cause. On-line filers will have a choice of using 
private-sector software that meets PBGC's published standards or using 
PBGC's software. Electronic premium filing will simplify filers' 
paperwork, improve accuracy of PBGC's premium records and database, and 
enable more prompt payment of premium refunds.
Plan actuarial and employer financial information required to be 
reported to PBGC by employers with large amounts of pension 
underfunding is required to be filed electronically under a final 
regulation issued in March 2005. Electronic filing will reduce the 
filing burden, improve accuracy, and better enable PBGC to monitor and 
manage risks posed by these plans.
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, mandatory electronic filing of premiums would 
apply a year later to plans with fewer than 500 participants than to 
larger plans. Also, the May 2004 proposed revisions to the penalty 
structure for failure to comply with the Participant Notice 
requirements scale down the penalty rate based on the number of plan 
participants.
The PBGC will continue to review its regulations to look for further 
simplification opportunities. The PBGC's regulatory plan for October 1, 
2005, to September 30, 2006, consists of one significant regulatory 
action.
_______________________________________________________________________



PBGC

                              -----------

                            FINAL RULE STAGE

                              -----------




134. 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 PBGC proposes to amend its benefit valuation and asset allocation 
regulations by adopting more current mortality tables and otherwise 
simplifying and improving its valuation assumptions and methods.

[[Page 64275]]

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                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           03/19/97                    62 FR 12982
ANPRM Comment Period End        05/19/97
NPRM                            03/14/05                    70 FR 12429
NPRM Comment Period End         05/13/05
Final Action                    11/00/05
Final Action Effective          12/00/05

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


URL For More Information:
www.pbgc.gov/regs

URL For Public Comments:
www.pbgc.gov/regs

Agency Contact:
James L. Beller
Attorney
Pension Benefit Guaranty Corporation
Legislative and Regulatory Department
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 64276]]




SMALL BUSINESS ADMINISTRATION (SBA)



Statement of Regulatory Priorities
Overview
The Small Business Administration's (SBA) mission is to maintain and 
strengthen the Nation's economy by enabling the establishment and 
viability of small businesses and by assisting in economic recovery of 
communities after disasters. In order to accomplish this mission, SBA 
focuses on improving the economic environment for small businesses; 
bridging the competitive opportunity gap facing small business 
entrepreneurs; and providing financial assistance for the restoration 
of homes and businesses affected by disasters.
 SBA is committed to:
 Working with its financial partners to improve small 
            businesses' access to capital through SBA's loan and 
            venture capital programs;
 Providing technical assistance to small businesses through its 
            resource partners;
 Increasing contracting and business opportunities for small 
            businesses;
 Providing affordable, timely and easily accessible financial 
            assistance to businesses, homeowners and renters after a 
            disaster;
 Measuring outcomes, such as revenue growth, job creation, 
            business longevity, and recovery rate after a disaster, to 
            ensure that SBA's programs and services are delivered 
            efficiently and effectively.
 SBA's regulatory actions reflect the goals and objectives of the 
agency and are designed to provide the small business and residential 
communities with the information and guidance they need to succeed as 
entrepreneurs and restore their homes or other property after a 
disaster. All of SBA's rules concern small businesses and programs that 
promote small businesses. In the coming year, SBA's regulatory 
priorities will focus on strengthening SBA's management of its programs 
and services, including the Small Business Lending Company and Lender 
Oversight programs, facilitating small business involvement in 
innovative manufacturing through modernization of the Small Business 
Innovation & Research and Small Business Technology Transfer programs, 
and promoting Federal contracting opportunities through the 
implementation of the Women-Owned Small Business Federal Contract 
Assistance program.
_______________________________________________________________________



SBA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




135. SMALL BUSINESS LENDING COMPANY AND LENDER OVERSIGHT REGULATIONS

Priority:


Other Significant


Legal Authority:


15 USC 634(b)(6); 15 USC 634(b)(7); 15 USC 634(b)(14); 15 USC 636(a); 
15 USC 636(m); 15 USC 650; 15 USC 687(f); 15 USC 697(a); 15 USC 
697e(c)(8)


CFR Citation:


13 CFR 120.460; 13 CFR 120.470; 13 CFR 120.1000 et seq.


Legal Deadline:


None


Abstract:


This rule would implement the Small Business Administration's (SBA) 
statutory authority under the Small Business Reauthorization and 
Manufacturing Assistance Act of 2004 (Reauthorization Act) to regulate 
Small Business Lending Companies (SBLCs) and non-federally regulated 
lenders (NFRLs). It also would conform SBA rules to various changes in 
the Section 7(a) Business Loan Program and the Certified Development 
Company (CDC) Program enacted by the Reauthorization Act.


In particular, this rule would: (1) define SBLCs and NFRLs; (2) clarify 
SBA's authority to regulate SBLCs and NFRLs; (3) authorize SBA to set 
minimum capital standards for SBLCs, to issue cease and desist orders, 
and revoke or suspend lending authority of SBLCs and NFRLs; (4) 
establish the Bureau of Premier Certified Lender Program Oversight in 
the Office of Lender Oversight; (5) transfer existing SBA enforcement 
authority over CDCs from the Office of Financial Assistance to the 
Office of Lender Oversight; and (6) define SBA's enforcement 
authorities relative to all SBA lenders participating in the 7(a) and 
CDC programs and intermediaries in the Microloan program; among other 
things.


Statement of Need:


Section 7(a) of the Small Business Act states that SBA may provide 
financing to small businesses ``directly or in cooperation with banks 
or other financial institutions.'' Presently, SBA guarantees loans 
through approximately 5,000 lenders. Of these lenders, about 14 are 
SBLCs that are not otherwise regulated by Federal or State chartering/
licensing agencies. SBA examines these SBLCs periodically. 
Congressional and Administration policy to delegate lending 
responsibilities to SBLCs and other SBA lenders requires that SBA 
increase its lender oversight. To that end, SBA will draft regulations 
that strengthen the Agency's management of its business loan and lender 
oversight programs.


Summary of Legal Basis:


Small Business Act, sec. 23(b)(3).


Alternatives:


This rulemaking amends and expands SBA's existing regulations on the 
SBLC and lender oversight programs.


Anticipated Cost and Benefits:


This rulemaking is designed to strengthen SBA's regulations regarding 
the SBLC Program and business loan and lender oversight programs. Some 
additional costs associated with additional reporting by the SBLCs, 
NFRLs, and other SBA lenders to the SBA are anticipated.


Risks:


This regulation poses no risks to the public health and safety or to 
the environment.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


Undetermined


Small Entities Affected:


 Businesses


Government Levels Affected:


None


Federalism:


 Undetermined


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

[[Page 64277]]

_______________________________________________________________________



SBA

                              -----------

                            FINAL RULE STAGE

                              -----------




136. SMALL BUSINESS TECHNOLOGY TRANSFER PROGRAM POLICY DIRECTIVE

Priority:


Other Significant


Legal Authority:


15 USC 638; PL 107-50


CFR Citation:


None


Legal Deadline:


Final, Statutory, February 15, 2002, Small Business Technology Transfer 
Program Reauthorization Act of 2001, enacted 10/15/2001, requires 
publication of policy directive modifications.


Abstract:


This Policy Directive would fulfill SBA's statutory obligation to 
provide guidance to the participating Federal agencies for the general 
operation of the Small Business Technology Transfer (STTR) Program. In 
particular, the Policy Directive would: (1) clarify STTR data rights 
pertaining to STTR Phase I, II, and III awards; (2) require the 
establishment of a STTR Program database that would be accessible to 
the Government and the public; (3) require participating agencies to 
increase the amount of their extramural budget reserved for STTR from 
0.15 percent to 0.3 percent; (4) permit agencies to increase the dollar 
value of STTR Phase II awards from $500,000 to $750,000; (5) permit 
agencies to approve a shorter or longer duration of time for award 
performance; and (6) to incorporate language implementing Executive 
Order 13329, ``Encouraging Innovation in Manufacturing;'' among other 
things.


Statement of Need:


In 1992, Congress enacted the Small Business Technology Transfer Act of 
1992 (STTR Act), Public Law No. 102-564 (codified at 15 U.S.C. 638). 
The STTR Act established the Small Business Technology Transfer Program 
(STTR Program) as a pilot program that required Federal agencies with 
extramural budgets for research or research and development (R/R&D) in 
excess of $1 billion per fiscal year to enter into funding agreements 
with small business concerns (SBCs) that engage in a collaborative 
relationship with a research institution. The purpose of the STTR 
Program is to stimulate a partnership of ideas and technologies between 
innovative SBCs and research institutions. The program assists the 
small business and research communities by developing commercially 
viable technologies. The STTR Program is a phased process, uniform 
throughout the Federal Government, of soliciting proposals and awarding 
funding agreements for R/R&D to meet stated agency needs or missions. 
The STTR Act requires the U.S. Small Business Administration (SBA) to 
``issue a policy directive for the general conduct of the STTR Programs 
within the Federal Government.'' (15 U.S.C. 638(p)(1)). SBA published 
its first STTR Policy Directive in 1993 (58 FR 42607-42620, August 10, 
1993). This Policy Directive fulfilled SBA's statutory obligation to 
provide guidance to the participating Federal agencies for the general 
operation of the STTR Program. Federal agencies participating in the 
STTR Program (STTR agencies) are obligated to follow the guidance 
provided by this Policy Directive. Each agency is required to review 
its rules, policies, and guidance on the STTR Program to ensure 
consistency with this Policy Directive and to make any necessary 
changes in accordance with each agency's normal procedures. This is 
consistent with the statutory authority provided to the SBA concerning 
the STTR Program.


On February 24, 2004, the President signed Executive Order (Order) 
13329, ``Encouraging Innovation in Manufacturing.`` This Order 
specifically requires the Small Business Administration (SBA) to: (1) 
establish, after consultation with the Director of the Office of 
Science and Technology Policy (Director), formats and schedules for 
submission of reports by the heads of departments and agencies; (2) 
issue to departments and agencies guidelines and directives (in 
addition to the formats and schedules) as the Administrator determines 
from time to time are necessary to implement the Order, after such 
guidelines and directives are submitted to the President, through the 
Director, for approval and are approved by the President. In addition, 
the heads of the agencies and departments with one or more SBIR or STTR 
programs are required: (1) to the extent permitted by law and in a 
manner consistent with the mission of that department or agency, to 
give high priority within such programs to manufacturing-related 
research and development to advance innovation, including innovation in 
manufacturing; and 2) to submit reports annually to the Administrator 
of the SBA and the Director concerning the efforts of such departments 
or agencies in implementing this Order.


Summary of Legal Basis:


In 1992, Congress enacted the Small Business Technology Transfer Act of 
1992 (STTR Act), Public Law No. 102-564 (codified at 15 U.S.C. 638). 
Congress has since amended the STTR Act, most recently with the 
enactment of the Small Business Technology Transfer Program 
Reauthorization Act of 2001 (Reauthorization Act), Public Law No. 107-
50. The Reauthorization Act extends the STTR Program through September 
30, 2009, and changed its status from a pilot program to a permanent 
one. The President signed Executive Order 13329, ``Encouraging 
Innovation in Manufacturing'' in 2004.


Alternatives:


There are no alternatives since it is mandated by law to issue a policy 
directive for the general conduct of the program.


Anticipated Cost and Benefits:


This directive does not impose any new substantive costs to small 
businesses or to the Federal Government. Instead, the directive ensures 
that the Federal agencies and departments are assisting the private 
sector consistent with the directive. The Small Business Technology 
Transfer Program Reauthorization Act of 2001 benefits small businesses 
by requiring participating agencies to increase the amount of their 
extramural budget to be reserved for the STTR Program from 0.15 percent 
to 0.3 percent and permits agencies to increase the dollar value of 
STTR Phase II awards from $500,000 to $750,000.


Risks:


This policy directive poses no risks to the public health and safety or 
to the environment.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Notice of Proposed Policy 
    Directive                   06/16/03                    68 FR 35748
Comment Period End              07/16/03
Final Action                    11/00/05

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Federal

[[Page 64278]]

Agency Contact:
Edsel Brown
Assistant Administrator for Technology, Office of Government 
Contracting/Business Development
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6450
Email: [email protected]
RIN: 3245-AE96
_______________________________________________________________________



SBA



137. SMALL BUSINESS INNOVATION RESEARCH (SBIR) POLICY DIRECTIVE

Priority:


Other Significant


Legal Authority:


15 USC 638(j)(1)


CFR Citation:


None


Legal Deadline:


None


Abstract:


On May 19, 2005, SBA proposed amendments to the Small Business 
Innovation and Research (SBIR) Program Policy Directive. Those 
amendments reflected the requirements that Executive Order 13329, 
``Encouraging Innovation in Manufacturing,'' February 24, 2004, imposed 
on SBA and Federal agencies participating in the SBIR Program (70 FR 
28975). In accordance with the Executive Order, SBA intends to issue 
guidelines on implementing the Executive Order, including requiring 
participating agencies to (1) give high priority to SBIR projects that 
are focused on manufacturing-related R&D in a manner consistent with 
their missions and the purpose of the SBIR program; (2) develop an 
action plan for implementing the order; and (3) report to SBA annually 
on these implementation plans.


Statement of Need:


On February 24, 2004, the President signed Executive Order (Order)13329 
``Encouraging Innovation in Manufacturing.'' This Executive order 
specifically requires the Small Business Administration (SBA) to: 1) 
establish, after consultation with the Director of the Office and 
Science and Technology Policy (Director), formats and schedules for 
submission of reports by the heads of departments and agencies; 2) 
issue to departments and agencies guidelines and directives (in 
addition to the formats and schedules) as the Administrator determines 
from time to time are necessary to implement the Order, after such 
guidelines and directives are submitted to the President, through the 
Director, for approval and are approved by the President. In addition, 
the heads of the agencies and departments with one or more SBIR or STTR 
programs are required: 1) to the extent permitted by law and in a 
manner consistent with the mission of that department or agency, to 
give high priority within such programs to manufacturing-related 
research and development to advance innovation including innovation in 
manufacturing and 2) to submit reports annually to the Administrator of 
the SBA and the Director concerning the efforts of such departments or 
agencies in implementing this Order.


Summary of Legal Basis:


In 1982, Congress enacted the Small Business Innovation Development Act 
of 1982 (SBIDA), Public Law 97-219 (codified at 15 U.S.C. 638), which 
established the Small Business Innovation Research Program (SBIR 
Program). SBIDA requires the SBA to ``issue Policy Directives for the 
general conduct of the SBIR programs within the Federal Government.'' 
(15 U.S.C. 638(j)(1)) In December of 2000, Congress enacted the Small 
Business Innovation Research Program Reauthorization Act of 2000 
(Reauthorization Act), Public Law 106-554. The Reauthorization Act 
extends the SBIR Program through September 30, 2008. SBA published its 
first Policy Directive, Policy Directive No. 65-01, 22 years ago (47 FR 
52966, November 24, 1982). The last SBIR Policy Directive amendments 
were published 2 years ago (67 FR 60072-60098, September 24, 2002).


Alternatives:


There are no practical alternatives that accomplish the objectives 
established by Executive Order 13329. An alternative to amending the 
SBIR Policy Directive that was considered was to issue a Special Policy 
Information Notice (SPIN) to the participating SBIR agencies and 
departments. SPINs have been used in the past in order to provide 
clarifying guidance on existing definitions or policy matters to the 
participating SBIR agencies and departments. As Executive Order 13329 
was a new Presidential initiative, a SPIN was not deemed the 
appropriate medium for providing guidance to the participants. Amending 
the Policy Directives was identified as the method for effective 
implementation of Executive Order 13329.


Anticipated Cost and Benefits:


The amendments to the Policy Directive do not impose any new 
substantive costs to small businesses. Further, implementing the 
Executive order does not impose any substantive cost to the Federal 
Government. Instead, implementing this Executive Order ensures that the 
Federal agencies and departments are assisting the private sector in 
its manufacturing innovation efforts.


Risks:


The amendments to the SBIR Policy Directive and the implementation of 
Executive Order 13329 pose no risks to the public health and safety or 
to the environment.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
Notice of Proposed Policy 
    Directive                   05/19/05                    70 FR 28975
Other/Comment Period End        06/20/05
Notice of Final Policy 
    Directive                   11/00/05

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Edsel Brown
Assistant Administrator for Technology, Office of Government 
Contracting/Business Development
Small Business Administration
409 Third Street SW
Washington, DC 20416
Phone: 202 205-6450
Email: [email protected]
RIN: 3245-AF21
BILLING CODE 8025-01-S

[[Page 64279]]




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), the Supplemental Security Income (SSI) 
program under title XVI of the Act and the Special Veterans Benefits 
under title XVIII of the Act. As directed by Congress, we also assist 
in administering portions of the Medicare program. 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 21 entries for the Regulatory Plan represent areas of major 
importance to the administration of the retirement, survivors, 
disability, SSI, and Medicare programs. Each individual initiative is 
described more fully after this Statement of Regulatory Priorities. 
Several of these regulatory priorities reflect the provisions of major 
laws that were recently enacted the Medicare Prescription Drug, 
Improvement and Modernization Act of 2003 (Pub. L. 108-173), the Social 
Security Protection Act of 2004 (Pub. L. 108-203) and the Intelligence 
Reform and Terrorism Prevention Act of 2004 (Pub. L. 108-458).
Improve the Disability Process
 As the continued improvement of the disability program is an area of 
vital interest to SSA, we have included in the Plan 12 initiatives that 
address disability.
 We are amending our administrative review process for benefit claims 
under title II of the Social Security Act (the Act) based on 
disability, and for applications for supplemental security income (SSI) 
payments based on disability or blindness under title XVI of the Act. 
We expect that the changes we are making will improve the accuracy and 
timeliness of decision-making throughout the disability determination 
process.
 We are including several initiatives that address issues involving 
attempts by disabled individuals to return to the workforce. A final 
rule will 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. Another proposed rule 
would, among other changes, require us to issue a receipt when an 
individual receiving disability benefits reports a change in work 
activity or earnings. This rule would also include home schooling as a 
form of regular school attendance for purposes of the Student Earned 
Income Exclusion and reflects provisions of the Social Security 
Protection Act of 2004. A final rule will establish time limits and 
other criteria for individuals receiving disability benefits who wish 
to initiate plans to achieve self-support. We are including two 
proposed rules concerning the continuing disability review (CDR). One 
would explain the standards we use to evaluate the work activity of an 
individual receiving disability benefits, and when we will conduct a 
CDR. The other would amend our regulation to suspend disability 
benefits when a beneficiary fails to cooperate with our request for 
information during a CDR.
 We are including a final rule that will clarify how we make a finding 
regarding medical equivalence.
 A proposed rule would revise the definitions of the age categories we 
use as a criterion in determining disability.
 Four initiatives would update the medical listings used to determine 
disability: final rules on digestive system disorders and 
cardiovascular disorders, and two proposed rules on immune system 
disorders and evaluating mental disorders. The revisions will ensure 
that the listings reflect advances in medical knowledge, treatment, and 
methods of evaluating these impairments.
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; one also reflects the goal to improve 
financial performance contained in the President's Management Agenda.
 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 proposed rules that reflect provisions of the Social 
Security Protection Act of 2004 intended to strengthen our oversight of 
the representative payee program.
 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 proposed rule on Federal salary offset 
that will enable us to collect qualifying, delinquent title II and XVI 
debts owed by former beneficiaries who are currently employed by the 
Federal government.
 A proposed rule would prohibit title II benefits to persons fleeing 
prosecution, custody, or confinement after conviction, and to persons 
violating probation or parole. This proposed rule reflects a provision 
of the Social Security Protection Act of 2004.
 A proposed rule will enhance the integrity of SSA's enumeration 
processes for assigning Social Security Numbers by reducing the 
opportunity for fraud. It would limit the number of Social Security 
Number cards an individual can obtain. This proposed rule reflects 
provisions of the Intelligence Reform and Terrorism Prevention Act of 
2004.
 Another proposed rule would reflect a provision of the Social Security 
Protection Act of 2004 concerning a requirement that certain non-
citizen workers must meet to establish entitlement to benefits of title 
II of the Act.
 A final rule will enhance our program integrity efforts by expanding 
our civil monetary penalties program. Included, among other activities, 
would be solicitations or mailings by outside individuals or entities 
that mislead the public into believing that SSA either approves, 
endorses, or authorizes the solicitations or mailings. This final rule 
reflects provisions of the Social Security Protection Act of 2004.
Simplify the SSI Program
 We are including a proposed rule that would reflect several provisions 
of the Social Security Protection Act of 2004, including simplifying 
the calculation of infrequent and irregular income, and other changes.
Implement Medicare Legislation
 SSA does not have overall responsibility for the Medicare program 
under title XVIII of the Social Security Act. However, the Medicare 
Prescription Drug, Improvement and Modernization Act of 2003 directs 
SSA to assist in administering portions of the Medicare program. We are 
including in the Plan two proposed rules that would implement the 
legislation.
 First, we expect to finalize rules concerning Medicare Prescription 
Drug

[[Page 64280]]

premium and cost-sharing subsidies (Medicare part D).
 Second, we propose rules on reduction of premium subsidies for the 
Supplementary Medical Insurance Benefit program (Medicare part B).
_______________________________________________________________________



SSA

                              -----------

                          PROPOSED RULE STAGE

                              -----------




138. 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 overpayment debts and administrative debts owed by 
individuals who are currently Federal employees. The debt collection 
would be accomplished by the partial reduction of the employee's 
disposable salary.


Statement of Need:


This regulation is required by 5 U.S.C. 5514(b) and by regulations of 
the Department of the Treasury (Treasury) 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. 1383(b) 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), 5 CFR 550.1104, and 31 CFR 285.7.


Anticipated Cost and Benefits:


Administrative costs are to be determined.


Risks:


At this time we have not identified any risks associated with the 
proposal.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            01/00/06
Final Action                    08/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Federal


Agency Contact:
Edward Johns
Financial Management Analyst
Social Security Administration
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0392

Robert J. Augustine
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-0020
RIN: 0960-AE89
_______________________________________________________________________



SSA



139. EXEMPTION OF WORK ACTIVITY AS A BASIS FOR A CONTINUING DISABILITY 
REVIEW (TICKET TO WORK AND WORK INCENTIVES IMPROVEMENT ACT OF 1999) 
(725P)

Priority:


Other Significant


Legal Authority:


42 USC 421(m)


CFR Citation:


20 CFR 404.903; 20 CFR 404.1574; 20 CFR 404.1575; 20 CFR 404.1590; 20 
CFR 404.1592a; 20 CFR 404.1594; 20 CFR 416.974; 20 CFR 416.990; 20 CFR 
416.994; 20 CFR 416.1403


Legal Deadline:


None


Abstract:


We are proposing to amend our regulations to explain how we will 
implement section 221(m) of the Social Security Act (the Act). We are 
also proposing to amend our regulation to eliminate the use of the 
secondary substantial gainful activity amount for evaluating work done 
by an employee prior to January 2001. Section 221(m) affects our rules 
for when we will conduct a continuing disability review if a 
beneficiary works and receives benefits under title II of the Act based 
on disability. (We interpret this section to include beneficiaries who 
receive both title II disability benefits and Supplemental Security 
Income (SSI) payments based on disability.) It also affects the way we 
evaluate work activity when deciding if a beneficiary has engaged in 
substantial gainful activity, and affects the standards we use when we 
determine whether disability continues or ends.


Statement of Need:


This regulation is necessary to clarify how SSA will implement section 
221(m) of the Social Security Act, which prohibits starting continuing 
disability reviews for certain beneficiaries based on work activity, 
and limits the use of the work activity of certain beneficiaries as 
evidence that the individual is no longer disabled.


Summary of Legal Basis:


This regulation implements section 221(m) of the Social Security Act, 
which was added by section 111 of Public Law 106-170.


Alternatives:


None.


Anticipated Cost and Benefits:


Over a five year period, this regulation will result in a net 
administrative cost of about $10 million and an SSA workyear savings of 
420 workyears. The estimates for program costs are $165 million in the 
first five years.


Risks:


At this time we have not identified any risks associated with this 
proposal.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/11/05                    70 FR 58999
NPRM Comment Period End         12/12/05
Final Action                    06/00/06

Regulatory Flexibility Analysis Required:


No

[[Page 64281]]

Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Kristine Erwin-Tribbitt
Social Insurance Specialist
Social Security Administration
Office of Program Development and Research
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-3353

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AE93
_______________________________________________________________________



SSA



140. REVISED MEDICAL CRITERIA FOR EVALUATING IMMUNE SYSTEM DISORDERS 
(804P)

Priority:


Other Significant


Legal Authority:


42 USC 405; 42 USC 902(a)(5); 42 USC 1383


CFR Citation:


20 CFR 404.1500, app 1


Legal Deadline:


None


Abstract:


We will update and revise the rules that we use to evaluate immune 
system disorders of adults and children who apply for, or receive, 
disability benefits under title II and Supplemental Security Income 
(SSI) payments based on disability under title XVI of the Social 
Security Act (the Act). The rules we will revise are sections 14.00 and 
114.00 in the Listing of Impairments in appendix 1 to subpart P of part 
404 of our regulations (the listings). These listings include such 
disorders as HIV/AIDS, systemic lupus erythematosus, and inflammatory 
arthritis.


Statement of Need:


These regulations are necessary to update the listings for evaluating 
immune system disorders to reflect advances in medical knowledge, 
treatment, and methods of evaluating these diseases. They ensure the 
determinations of disability have a sound medical basis, that claimants 
receive equal treatment through the use of specific criteria, and that 
individuals 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. 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 diseases. The current listings 
are now over 11 years old. Medical advances in disability evaluation 
and treatment and our program experience make clear that the current 
listings do not reflect state-of-art medical knowledge and technology.


Anticipated Cost and Benefits:


We anticipate that if finalized, these proposed rules will result in 
negligible program and administrative costs.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           05/09/03                    68 FR 24896
ANPRM Comment Period End        07/08/03
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Paul J. Scott
Social Insurance Specialist
Social Security Administration
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-1192

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF33
_______________________________________________________________________



SSA



141. REVISED MEDICAL CRITERIA FOR EVALUATING MENTAL DISORDERS (886P)

Priority:


Other Significant


Legal Authority:


42 USC 405; 42 USC 902(a)(5); 42 USC 1383


CFR Citation:


20 CFR 404.1500, app 1; 20 CFR 404.1520; 20 CFR 404.1520a; 20 CFR 
404.1528; 20 CFR 416.920a; 20 CFR 416.928


Legal Deadline:


None


Abstract:


We propose to update and revise the rules that we use to evaluate 
mental disorders of adults and children who apply for, or receive, 
disability benefits under title II and Supplemental Security Income 
(SSI) payments based on disability under title XVI of the Social 
Security Act (the Act). The rules we plan on revising are sections 
12.00 and 112.00 in appendix 1 to subpart P of part 404 of our 
regulations (the listings). These listings include such disorders as 
affective disorders, schizophrenic disorder, intellectual disabilities, 
and autistic disorders.


Statement of Need:


These regulations are necessary to update the listings for evaluating 
mental disorders to reflect advances in medical knowledge, treatment, 
and methods of evaluating these diseases. They ensure that 
determinations of disability have a sound medical basis, that claimants 
receive equal treatment through the use of specific criteria, and

[[Page 64282]]

that individuals 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. 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 diseases. We have not 
comprehensively revised the current listings in over 15 years. 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.


Anticipated Cost and Benefits:


The administrative cost of this regulation is to be determined.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           03/17/03                    68 FR 12639
ANPRM Comment Period End        06/16/03
NPRM                            06/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


None


Agency Contact:
Marva Franklin
Social Insurance Specialist
Social Security Administration
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1293
RIN: 0960-AF69
_______________________________________________________________________



SSA



142. AMENDMENTS TO THE TICKET TO WORK AND SELF-SUFFICIENCY PROGRAM 
(967P)

Priority:


Other Significant


Legal Authority:


42 USC 902(a)(5); 42 USC 1320b-19; PL 106-170, sec 101


CFR Citation:


20 CFR 411.110; 20 CFR 411.120 to 411.155; 20 CFR 411.165; 20 CFR 
411.166; 20 CFR 411.170; 20 CFR 411.171; 20 CFR 411.175; 20 CFR 
411.180; 20 CFR 411.190; 20 CFR 411.210; 20 CFR 411.325; 20 CFR 411.350 
to 411.370; 20 CFR 411.385 to 411.395; 20 CFR 411.500 to 411.515; 20 
CFR 411.525 to 411.565; 20 CFR 411.566; 20 CFR 411.575 to 411.590


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's 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, in 
increase the incentives for providers of employment services, 
vocational rehabilitation services, and other support services to 
participate in this program.


Statement of Need:


This proposed regulatory action is necessary to respond to our 
experience and the recommendations we have received since we began 
implementation of the Ticket to Work and Self-Sufficiency Program in 
February 2002. These changes are intended to increase the incentives 
for providers of employment, 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 the 
eligibility to receive a ticket, the clarification of the rules for 
assignment of a ticket to a State VR agency, and the amendment of the 
rules for paying ENs are necessary to increase participation in the 
Ticket to Work program by both service providers and the beneficiaries 
with disabilities. This will increase the opportunities for the 
beneficiaries to seek the services necessary to obtain and retain 
employment and reduce their dependency on cash benefit programs.


Anticipated Cost and Benefits:


We anticipate initial costs to increase due to up-front payments to 
ENs, and then increased program savings in later years as ENs assist 
more beneficiaries to achieve self-sufficiency and reduce 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.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/30/05                    70 FR 57222
NPRM Comment Period End         12/29/05
Final Action                    01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


State


Agency Contact:
Dan O'Brien
Social Insurance Specialist
Social Security Administration
Office of Employment Support Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 597-1632

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AF89

[[Page 64283]]

_______________________________________________________________________



SSA



143. REPRESENTATIVE PAYMENT; POLICIES AND ADMINISTRATIVE PROCEDURE FOR 
IMPOSING PENALTIES FOR FALSE OR MISLEADING STATEMENTS OR WITHHOLDING OF 
INFORMATION (2422P)

Priority:


Other Significant


Legal Authority:


42 USC 405(j); 42 USC 1007; 42 USC 1383(a)(2); PL 108-203, sec 102; PL 
108-203, sec 103; PL 108-203, sec 104; PL 108-203, sec 105; PL 108-203, 
sec 106; PL 108-203, sec 201


CFR Citation:


20 CFR 404.459; 20 CFR 404.2022; 20 CFR 404.2035; 20 CFR 404.2040a; 20 
CFR 404.2041(f); 20 CFR 404.2065; 20 CFR 408.665; 20 CFR 416.622; 20 
CFR 416.635; 20 CFR 416.640a; 20 CFR 416.641(f); 20 CFR 416.665; 20 CFR 
416.1340


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 
proposed regulations are required to further our program integrity 
efforts.


In order to reflect and implement section 201 of Public Law 108-203 we 
propose regulations for imposing penalties for withholding of 
information when the person knows or should know that the failure to 
provide the information is misleading.


Statement of Need:


These proposed regulations, which reflect certain provisions of Public 
Law 108-203, would modify existing representative payee procedures by: 
(1) Expanding the scope of disqualification to prohibit an individual 
from serving as representative payee if he or she is convicted of 
offenses resulting in imprisonment for more than one year or is fleeing 
to avoid prosecution, custody, or confinement after conviction; (2) 
requiring annual certifications from nongovernmental fee for service 
organizational payees that they are licensed and bonded; (3) requiring 
a fee for service representative payee to forfeit their fee for the 
months during which funds were misused; (4) requiring a representative 
payee to receive benefits in person at a local social security field 
office if they fail to provide an annual accounting of benefits; and 
(5) explaining financial requirements for representative payees.


Public Law 108-203 also provides for SSA to impose a penalty on any 
person who knowingly withholds information that is material for use in 
determining any right to or the amount of monthly benefits under title 
II or XVI.


Summary of Legal Basis:


These proposed regulations implement sections 102 to 106, and 201 of 
Public Law 108-203.


Alternatives:


None.


Anticipated Cost and Benefits:


The net administrative cost, which is attributable to Public Law 108-
203 and not to these regulations, is estimated to be $20 million and 
250 workyears over 5 years.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/00/05
Final Action                    06/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Organizations


Government Levels Affected:


None


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-AG09
_______________________________________________________________________



SSA



144. ISSUANCE OF WORK REPORT RECEIPTS, PAYMENT OF TWP MONTHS AFTER A 
FRAUD CONVICTION, CHANGES TO THE SEIE, & EXPANSION OF THE REENTITLEMENT 
PERIOD FOR CHILDHOOD DIB BENEFITS (2502P)

Priority:


Other Significant


Legal Authority:


42 USC 402; 42 USC 403; 42 USC 404(a); 42 USC 404(e); 42 USC 405(a) to 
405(d); 42 USC 405(h); 42 USC 405 note; 42 USC 416(1); 42 USC 421(a); 
42 USC 421(i); 42 USC 421 note; 42 USC 422(c); 42 USC 423(e); 42 USC 
425; 42 USC 428(a) to 428(e); 42 USC 902(a); 42 USC 902(5); 42 USC 902 
note; 42 USC 1320 a-8a; 42 USC 1320 b-17; 42 USC 1381; 42 USC 1382; 42 
USC 1382 note; 42 USC 1382a(b); 42 USC 1383


CFR Citation:


20 CFR 404.351; 20 CFR 404.401a; 20 CFR 404.471; 20 CFR 404.903; 20 CFR 
404.1588; 20 CFR 404.1592; 20 CFR 416.708(c); 20 CFR 416.1112(c)(3); 20 
CFR 416.1403; 20 CFR 416.1861


Legal Deadline:


None


Abstract:


We are proposing to amend our rules to reflect and implement sections 
202, 208, 420A and 432 of the Social Security Protection Act of 2004 
(the SSPA). Section 202 of the SSPA requires us to issue a receipt each 
time you or your representative report a change in your work activity 
or give us documentation of a change in your earnings if you receive 
benefits based on disability under title II or title XVI of the Social 
Security Act (the Act) until such time as the Commissioner implements a 
centralize computer file. Section 208 changes the way we pay benefits 
during the trial work period if you are convicted by a Federal court of 
fraudulently concealing your work activity. Section 420A allows you to 
be re entitled to childhood disability benefits at any time if your 
previous entitlement to childhood disability benefits terminated 
because of the performance of substantial gainful activity. Section 432 
changes the way we decide if you are eligible for the student earned 
income exclusion. We also propose to change the SSI student policy to 
include home schooling as a form of regular school attendance when

[[Page 64284]]

determining eligibility for the student earned income exclusion.


Statement of Need:


This regulation is necessary to implement the program improvements 
established in the SSPA. The regulation will improve our service to 
individual beneficiaries who attempt to work and improve our ability to 
protect the programs from certain types of fraud.


Summary of Legal Basis:


This regulation implements Sections 202, 208, 420A and 432 of Public 
Law 108-203.


Alternatives:


None.


Anticipated Cost and Benefits:


The administrative impact of these proposed rules is estimated to be 
negligible (i.e., less than $2 million or 25 workyears). Any 
administrative impact would be attributable to Public Law 108-203 and 
not to these regulations.


Risks:


At this time we have not identified any risks to this proposal.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            11/00/05
Final Action                    07/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Cindy Duzan
Social Insurance Specialist
Social Security Administration
Office of Program Development and Research
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-4203

Suzanne DiMarino
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1769
RIN: 0960-AG10
_______________________________________________________________________



SSA



145. MEDICARE PART B INCOME-RELATED MONTHLY ADJUSTMENT AMOUNT (2101P)

Priority:


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


Legal Authority:


42 USC 405; 42 USC 902(a)(5); 42 USC 1395r(i); PL 108-173


CFR Citation:


20 CFR 418 (New)


Legal Deadline:


None


Abstract:


We propose to add to our regulations a new part 418 that would include 
our rules applicable to reduction of premium subsidies for 
beneficiaries who have income above a threshold amount. Section 811 of 
the Medicare Prescription Drug, Improvement and Modernization Act of 
2003 amends section 1839 of the Act. Starting in 2007, the new 
subsection 1839(i) requires that Medicare part B enrollees with income 
above a threshold amount specified in the law receive a reduced part B 
premium subsidy. The statute establishes four income ranges above the 
threshold, and prescribes a percentage adjustment of premiums for each 
range. As income increases, the premium subsidy decreases. In effect, 
the Medicare Part B premium will increase for individuals with income 
above the threshold. All beneficiaries will continue to receive some 
subsidy of the Medicare Part B premium. The income threshold in 2007 is 
$80,000 ($160,000 for an individual who files a joint income tax 
return). The premium adjustments will be phased in over a five year 
period from 2007 through 2011. After 2007, the threshold amount and all 
of the income range amounts will be annually adjusted for inflation.


Statement of Need:


Regulations required by statute.


Summary of Legal Basis:


Section 1839(i) of the Social Security Act.


Alternatives:


None. The Social Security Act directs the Commissioner to establish 
regulations to implement this provision. The statute requires the 
Commissioner to establish regulations regarding temporary use of tax 
year data from a year other than the year ordinarily used to determine 
premium adjustments, establishment of premium adjustments for Medicare 
Part B when IRS tax data is not available, and specification of ``life-
changing events'' that meet the standard for use of more recent tax 
year data, and a methodology for making such adjustments.


Anticipated Cost and Benefits:


The Medicare Part B income-related premium subsidy reduction was 
established to produce Federal savings in the Medicare program. The 
Congressional Budget Office estimates that this provision will produce 
$13.3 billion in savings from 2007 through 2013.


Risks:


None identified.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            11/00/05

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Undetermined


Agency Contact:
Craig Streett
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9793

Lois A. Berg
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1713
RIN: 0960-AG11
_______________________________________________________________________



SSA



146. NONPAYMENT OF BENEFITS TO FUGITIVE FELONS AND PROBATION OR PAROLE 
VIOLATORS (2222P)

Priority:


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


Legal Authority:


42 USC 402; 42 USC 404(a); 42 USC 404(e); 42 USC 405(a); 42 USC 405(c);

[[Page 64285]]

42 USC 423(e); 42 USC 424a; 42 USC 902(a)(5); 42 USC 902(a)(5); 48 USC 
1801


CFR Citation:


20 CFR 404.471(new); 20 CFR 416.202; 20 CFR 416.1339


Legal Deadline:


None


Abstract:


These regulations will propose rules for nonpayment of title II 
benefits to persons avoiding prosecution, custody or confinement after 
conviction and to persons violating probation or parole. We will also 
propose rules for establishing that good cause exists for continuing to 
pay such benefits for titles II and XVI.


Statement of Need:


Public Law 108-203, the Social Security Protection Act of 2004, extends 
the fugitive felon nonpayment provision to title II beneficiaries under 
section 202(x) of the Social Security Act, effective January 2005, if 
an outstanding warrant exists for 30 continuous days or more. It also 
provides a good cause exception that, if met, provides for the 
continued payment of titles II and XVI benefits. The good cause 
exception requires the Commissioner to apply good cause if a court 
finds the person not guilty, charges are dismissed, a warrant for 
arrest is vacated, there are similar exonerating circumstances 
identified by the court, or the individual establishes that he or she 
was the victim of identity fraud and the warrant was issued on such 
basis. Public Law 108-203 also gives the Commissioner the discretionary 
authority to establish good cause based on mitigating factors if the 
criminal offense is nonviolent and not drug-related, and in the case of 
probation or parole violators, if the underlying offense is nonviolent 
and not drug-related.


Summary of Legal Basis:


Section 203 of Public Law 108-203.


Alternatives:


None.


Anticipated Cost and Benefits:


There are no anticipated costs and benefits resulting from this 
regulatory action. Any program savings from nonpayment to fugitive 
felons will be the result of implementing Public Law 108-203.


Risks:


The fugitive felon provision of title XVI of the Act has been the 
subject of litigation. Future litigation over the program is 
anticipated with respect to the term ``fleeing to avoid'' and our 
interpretation of the effective date provision of section 203 of the 
SSPA. In addition, the discretionary good cause exceptions to the 
titles II and XVI provisions may be perceived as either bestowing an 
unjust benefit on felons or being unnecessarily restrictive.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Bill Hilton
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-2468

Richard M. Bresnick
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1758
RIN: 0960-AG12
_______________________________________________________________________



SSA



147. CHANGES TO THE INCOME AND RESOURCES PROVISIONS FOR SSI BASED ON 
SECTIONS 430, 435, AND 436 OF THE SOCIAL SECURITY PROTECTION ACT (SSPA) 
OF 2004 (2482P)

Priority:


Other Significant


Legal Authority:


42 USC 902(a)(5); 42 USC 1381a; 42 USC 1382; 42 USC 1382a; 42 USC 
1382b; 42 USC 1382c(f); 42 USC 1382j


CFR Citation:


20 CFR 416.1111; 20 CFR 416.1112; 20 CFR 416.1123; 20 CFR 416.1124; 20 
CFR 416.1161; 20 CFR 416.1210; 20 CR 416.1250 (New)


Legal Deadline:


None


Abstract:


The proposed regulations are required to implement legislation, 
specifically sections 430, 435 and 436 of Public Law 108-203, the 
Social Security Protection Act of 2004, which was enacted March 2, 
2004.


Statement of Need:


These regulations, which reflect certain sections of Public Law 108-
203, modify existing Supplemental Security Income (SSI) policies under 
Title XVI of the Social Security Act (the Act) by: (1) Changing the 
calculation of infrequent or irregular income from a monthly to a 
quarterly basis and excluding the first $60 dollars of unearned income 
and the first $30 dollars of earned income from such infrequent or 
irregular income; (2) excluding from income any interest or dividend 
income earned on a countable resource or a resource excluded under a 
Federal statute other than the Act; (3) excluding from income, gifts 
used to pay tuition, fees or other necessary educational expenses at 
any educational institution, including vocational and technical 
training; (4) excluding from resources for 9 months beginning the month 
after the month of receipt, any portion of grants, scholarships, 
fellowships or gifts used to pay tuition, fees or other necessary 
educational expenses at any educational institution; and (5) under the 
discretionary authority of the Commissioner of Social Security (the 
Commissioner), considering wages and unearned income from the Uniformed 
Services to be received in the month in which the compensation was 
earned rather than paid both for eligible individuals and deemors. We 
also propose to apply the preceding changes to how we count the income 
and resources of ineligible spouses and parents.


Summary of Legal Basis:


These regulations implement sections 430, 435 and 436 of Public Law 
108-203.


Alternatives:


The only alternative was not to apply the exclusions in sections 430, 
435 and 436 of the SSPA to the deeming process. Section 1614(f) of the 
Act grants the Commissioner the discretion to waive the deeming of 
income and resources from an ineligible spouse or parent to an eligible 
individual when the Commissioner determines that deeming would be 
inequitable under

[[Page 64286]]

the circumstances. However, extending these exclusions to the deeming 
process is consistent with the SSI program's longstanding policy of 
treating the income and resources of spouses and parents comparably to 
the income and resources of the eligible individual.


Anticipated Cost and Benefits:


The net administrative savings of section 430, 435 and 436 of the SSPA, 
which is attributable to Public Law 108-203 and not to these 
regulations, is estimated to be about $4 million and 50 workyears over 
5 years.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/06/05                    70 FR 52949
NPRM Comment Period End         11/07/05
Final Action                    06/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Barbara E. Snyder
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-5655

Lois A. Berg
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1713
RIN: 0960-AG13
_______________________________________________________________________



SSA



148. CONTINUING DISABILITY REVIEW FAILURE TO COOPERATE PROCESS (2763P)

Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


42 USC 402; 42 USC 405(a); 42 USC 405(b); 42 USC 405(d) to 405(h); 42 
USC 416(i); 42 USC 421(a); 42 USC 421(i); 42 USC 422(c); 42 USC 423; 42 
USC 425; 42 USC 902(a)(5); 42 USC 1382; 42 USC 1382c; 42 USC 1382h; 42 
USC 1383(a); 42 USC 1383(c); 42 USC 1383(d)(1)


CFR Citation:


20 CFR 404.1587; 20 CFR 404.1596; 20 CFR 416.992


Legal Deadline:


None


Abstract:


We propose to amend our regulations to provide that we will suspend 
your disability benefits before we make a determination during a 
continuing disability review (DR) under title II of the Social Security 
Act (the Act) when you fail to comply with our request for necessary 
information. Should you remain non-compliant for a period of one year 
following your suspension, we will then terminate your disability 
benefits. We are proposing these revisions to conform out title II 
policy to our current title XVI policy. Although our current title XVI 
regulations provide for the suspension and termination of payments 
after 12 months, we are proposing to amend these regulations by 
restating this policy in the CDR regulatory provisions.


Statement of Need:


The regulatory changes are being proposed to conform our title II 
procedures for determining whether you continue to meet the disability 
requirements to our current title XVI procedures.


Summary of Legal Basis:


This proposed change is not required by statute or court order.


Alternatives:


A change in the statute is not necessary in order to implement this 
change.


Anticipated Cost and Benefits:


The proposed rules will have a negligible administrative savings per 
year (i.e., less than $2 million or 25 workyears).


The Office of the Chief Actuary estimated that net savings for FY 2006 
through FY 2010 would be $48 million. However, there is the possibility 
that the new procedure could impact the number of beneficiaries who 
fail to cooperate, which could result in smaller savings or even a net 
cost, but there is no reliable empirical evidence with which to 
investigate this possibility.


Risks:


The only risk may be if beneficiaries complain that their benefits have 
stopped. However, since a beneficiary who meets the other factors of 
entitlement only has to cooperate in order to have their benefits 
resumed the risk appears to be minimal.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            01/00/06
Final Action                    07/00/06

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Undetermined


Agency Contact:
Rosemarie Greenwald
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-7813
RIN: 0960-AG19
_______________________________________________________________________



SSA



149. PROHIBITION OF ENTITLEMENT ON EARNINGS RECORDS FOR CERTAIN ALIEN 
WORKERS (2882P)

Priority:


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


Legal Authority:


42 USC 414(c); 42 USC 423(a)(1)(C); PL 108-203, sec 211


CFR Citation:


20 CFR 404.110; 20 CFR 404.120; 20 CFR 404.130; 20 CFR 404.315; 20 CFR 
404.1912; 20 CFR 404.1931


Legal Deadline:


None


Abstract:


The proposed rule will revise our regulations on insured status to 
include an additional insured status requirement under Section 211 of 
Public Law 108-203--the Social Security Protection Act of 2004 (SSPA)--
for noncitizen workers who

[[Page 64287]]

were originally assigned a Social Security number (SSN) on or after 
January 1, 2004. Under this law, a noncitizen worker must meet either 
of the following additional requirements to be fully or currently 
insured and to establish entitlement to any Title II benefit based on 
his/her earnings:


 The noncitizen worker must have been issued an SSN for work 
purposes at any time on or after January 1, 2004; or


 The noncitizen worker must have been admitted to the U.S. at 
any time as a nonimmigrant visitor for business (immigration category 
``B-1'') or as an ``alien crewman'' (immigration category ``D-1'' or 
``D-2'').


If a noncitizen worker whose SSN was originally assigned on or after 
January 1, 2004 does not meet either of these requirements, then he/she 
is not fully or currently insured; thus entitlement is precluded. This 
is true even if the noncitizen worker appears to have the required 
number of quarters of coverage (QCs) in accordance with the regular 
insured status provisions. While the additional insured status 
requirement applies directly to certain noncitizen workers, it also 
affects the entitlement of any person seeking a benefit on the record 
of a noncitizen who is subject to this law.


A noncitizen worker who was properly assigned an SSN before January 1, 
2004 is not subject to Section 211 of the SSPA.


Statement of Need:


We are codifying the statutory changes in our rules even though SSA has 
already implemented Section 211 of the SSPA by issuing instructions to 
claims adjudicators in our Program Operations Manual System (POMS). By 
incorporating the changes mandated by the law in our regulations, our 
program rules and operating instructions will be consistent with the 
statute.


Summary of Legal Basis:


The proposed revisions to our regulations are needed to implement 
Section 211 of the SSPA.


Alternatives:


None


Anticipated Cost and Benefits:


Administrative start-up costs were nominal since we already implemented 
the law via POMS instructions and adjudicator training. No systems 
changes were needed. Benefits include savings to the Title II Trust 
Funds and in administrative enumeration costs since some claimants who 
are denied under this law will not be able to get an SSN card for non-
work purposes.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            06/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Jessica Burns
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-8481

Richard M. Bresnick
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1758
RIN: 0960-AG22
_______________________________________________________________________



SSA



150.  LIMITING REPLACEMENT OF SOCIAL SECURITY NUMBER CARDS 
(965P)

Priority:


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


Legal Authority:


42 USC 405; 42 USC 432; 42 USC 902(a)(5); 42 USC 1320b-1; 42 USC 1320b-
13; PL 108-458, sec 7213(a)(1)(A)


CFR Citation:


20 CFR 422.103 to 422.110


Legal Deadline:


None


Abstract:


The proposed rule will revise our regulations to indicate that 
replacement SSN cards will be limited to three per year and ten per 
lifetime. The Commissioner will allow certain exceptions to these 
limits on a case-by-case basis in compelling circumstances. 
Furthermore, when determining these limits, SSA will not consider 
replacement SSN cards issued for the purpose of changing the 
numberholder's (NH) name or for changes in alien status that result in 
a necessary change to a restrictive legend on the SSN card, because we 
believe these situations satisfy the compelling circumstances test. We 
want to ensure the accuracy of our records by encouraging number 
holders to report name changes and changes in alien status.


Statement of Need:


We are codifying the statutory change in our rules. These revisions of 
our regulations facilitate the implementation of Section 7213(a)(1)(A) 
of the Intelligence Reform and Terrorism Prevention Act (IRTPA) of 
2004. Previously, there have never been any limits placed on the number 
of cards an individual receives over the course of a year or a lifetime 
other than a protocol in our electronic records that prevents the 
issuance of a replacement SSN card within seven days of a previous 
issuance.


Summary of Legal Basis:


The revision to our regulations are needed to implement Section 
7213(a)(1)(A) of IRTPA.


Alternatives:


None.


Anticipated Cost and Benefits:


Administrative costs are estimated to be negligible (i.e., less than $2 
million or 25 workyears). Any costs attributable to this regulation are 
due to the legislation and not to the regulation itself.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            12/00/05
Final Action                    06/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None

[[Page 64288]]

Agency Contact:
Karen Cool
Social Insurance Specialist
Social Security Administration
OISP
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-7094

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-AG25
_______________________________________________________________________



SSA



151.  AGE AS A FACTOR IN EVALUATING DISABILITY (3183P)

Priority:


Other Significant


Legal Authority:


42 USC 405(a); 42 USC 423; 42 USC 1382c; 42 USC 902(a)(5)


CFR Citation:


404.1562; 404.1563; 404.1568; 404P appendix 2; 416.962; 416.963; 
416.968


Legal Deadline:


None


Abstract:


We are proposing to revise the definitions of the age categories we use 
as one of the criteria in determining disability under titles II and 
XVI of the Social Security Act (the Act). The proposed changes reflect 
our adjudicative experience, advances in medical treatment and 
healthcare, changes in the workforce since we originally published our 
rules for considering age in 1978, and current and future increases in 
the full retirement age under Social Security law. The proposed changes 
would not affect the rules under part 404 of our regulations for 
individuals age 55 or older who have statutory blindness. They also 
would not affect our other rules that are dependent on age, such as the 
age at which you can qualify for early retirement benefits or for 
Medicare as a retired individual.


Statement of Need:


These changes are needed to ensure that our regulations are as up-to-
date as possible. We have not substantively revised the age categories 
we use for determining disability since we first published them more 
than 25 years ago.


Summary of Legal Basis:


Administrative. Not required by statute or court order.


Alternatives:


None.


Anticipated Cost and Benefits:


To be determined.


Risks:


At this time, we have not identified any risks to this proposal.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            10/00/05

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-AG29
_______________________________________________________________________



SSA



152.  ADMINISTRATIVE REVIEW PROCESS FOR ADJUDICATING INITIAL 
DISABILITY CLAIMS (3203F)

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


42 USC 401(j); 42 USC 404(f); 42 USC 405(a); 42 USC 405(b); . . .


CFR Citation:


20 CFR 404.903; 20 CFR 404.1502; 20 CFR 404.1503; 20 CFR 404.1512; . . 
 


Legal Deadline:


None


Abstract:


In order to improve the accuracy, consistency, and timeliness of 
decision making throughout its disability determination process, we 
propose to change its four-step administrative review process for 
benefit claims filed under title II of the Social Security Act (Act) 
based on disability, and for applications filed for supplemental 
security income (SSI) payments based on disability or blindness under 
title XVI of the Act. We expect that the proposed changes will 
significantly reduce our current disability case processing times, 
increase decisional consistency and accuracy, and ensure that the right 
determination or decision is made as early in the disability 
determination process as possible.


Statement of Need:


Over the years, the Social Security and SSI disability programs have 
grown in size and complexity, and there has been significant growth in 
the number of claims filed for disability benefits each year. During 
the early years of the Social Security disability program, the number 
of claims filed each year was measured in the hundreds of thousands. 
Currently, more than two and a half million individuals apply for 
Social Security and SSI benefits based on disability each year. That 
volume will grow even more in future years as baby boomers move into 
their disability-prone years. In light of these factors, the need to 
make substantial changes in our disability determination process has 
become a high priority.


Summary of Legal Basis:


These proposed rules are based on the broad authority the Commissioner 
of Social has under sections 205(a), 1631(d)(1) and 702(b)(5) of the 
Act to promulgate rules and regulations governing the administration of 
the disability determination process.


Alternatives:


We could maintain the current four-step administrative review process 
and rely on our transition to an electronic disability process--one 
usually referred to as eDib--to reduce current processing times and 
improve the efficiency of the current disability determination process. 
In an electronic disability process, applications, claimant information 
and medical evidence that have been processed in paper form in the past 
are processed in electronic form instead. eDib provides opportunities 
to manage and process workloads in ways that have not existed until 
now. However, eDib alone is not enough to improve the current process 
to the level that we deem necessary.


Anticipated Cost and Benefits:


To be determined.

[[Page 64289]]

Risks:


Maintaining the status quo likely would result in the General 
Accountability Office (GAO) continuing to designate modernizing federal 
disability programs, including our disability programs, as a high-risk 
area. The GAO has listed this as a high-risk area since 2003 (refer to 
GAO-05-207, High-Risk Series, An Update, January 2005).


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            07/27/05                    70 FR 43589
NPRM Comment Period End         10/25/05
Final Action                    01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Mary Chatel
Executive Director
Social Security Administration
Disability Service Improvement
500 E Street, SW, Suite 854
Washington, DC 20254
Phone: 202 358-6094
RIN: 0960-AG31
_______________________________________________________________________



SSA

                              -----------

                            FINAL RULE STAGE

                              -----------




153. EVIDENTIARY REQUIREMENTS FOR MAKING FINDINGS ABOUT MEDICAL 
EQUIVALENCE (787F)

Priority:


Other Significant


Legal Authority:


42 USC 405; 42 USC 902(a)(5); 42 USC 1383


CFR Citation:


20 CFR 404.1525 to 404.1527; 20 CFR 404.1529; 20 CFR 416.925; 20 CFR 
416.926; 20 CFR 416.926a; 20 CFR 416.927; 20 CFR 416.929


Legal Deadline:


None


Abstract:


This notice of proposed rulemaking will clarify that we will consider 
the medical severity of the individual's impairment, based on all 
relevant evidence in the case record when we make a finding regarding 
medical equivalence. These rules will clarify our medical equivalence 
policy in light of the decision in Hickman v. Apfel, 187 F.3d 683 (7th 
Cir. 1999).


Statement of Need:


We developed these proposed rules to restore consistency in our 
regulatory language and to clarify the language in 20 CFR 404.1526 and 
20 CFR 416.926 of our regulations, the rules we use for making findings 
about medical equivalence to listings in the Listing of Impairments.


Summary of Legal Basis:


Administrative--not required by statute or court order.


Alternatives:


We considered not making the language in 20 CFR 404.1526 and 20 CFR 
416.926 consistent. However, because determining medical equivalence is 
the same under title II and title XVI, we believe it is important that 
the language in the two sections be consistent. We also considered not 
making the other clarifying revisions in the NPRM. However, because the 
court in Hickman v. Apfel, 187 F.3d 683 (7th Cir. 1999) interpreted our 
statement in 20 CFR 416.926(b) that ``[w]e will always base our 
decision about whether your impairment(s) is medically equal to a 
listed impairment on medical evidence only`` differently from what we 
intended, we believe the proposed revisions are necessary to clarify 
our intent. We intend the phrase ''medical evidence only`` in this 
regulation section only to exclude consideration of the vocational 
factors of age, education, and work experience. The proposed revisions 
make the language in the two sections identical and clarify our intent 
of how medical equivalence is to be determined in response to the 
Hickman decision.


Anticipated Cost and Benefits:


The administrative cost of this regulation is estimated to be 
negligible (i.e., less than $2 million or 25 workyears) since the 
proposed rules are simply a clarification of our current longstanding 
policy on determining medical equivalence.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            06/17/05                    70 FR 35188
NPRM Comment Period End         08/16/05
Final Action                    08/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Regina Connell
Social Insurance Specialist
Social Security Administration
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235
Phone: 410 965-1891

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-AF19
_______________________________________________________________________



SSA



154. 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:


Sections 5.00 and 105.00, Digestive Disorders, of appendix 1 subpart P 
of part 404 of our regulations (404.1501 through 404.1599) describe 
those impairments that are considered severe enough to prevent a person 
from doing any gainful activity, or for a child claiming SSI payments 
under title XVI, that causes marked and severe functional limitations. 
We are revising these sections to ensure that the

[[Page 64290]]

medical evaluation criteria are up-to-date and consistent with the 
latest advances in medical knowledge and treatment. 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.


Anticipated Cost and Benefits:


To be determined.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            11/14/01                    66 FR 57009
NPRM Comment Period End         01/14/02
NPRM Comment Period 
    Reopened                    11/08/04                    69 FR 64702
Comment Period End              01/07/05
Final Action                    02/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Nancy Torkas
Social Insurance Specialist
Social Security Administration
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
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



155. REVISED MEDICAL CRITERIA FOR EVALUATING CARDIOVASCULAR DISORDERS 
(826F)

Priority:


Other Significant


Legal Authority:


42 USC 405; 42 USC 902(a)(5); 42 USC 1383


CFR Citation:


20 CFR 404.1500, app 1


Legal Deadline:


None


Abstract:


Sections 4.00 and 104.00, Cardiovascular Impairments, of appendix 1 to 
subpart P of our regulation (20 CFR 404.1501 through 404.1599) describe 
those impairments that are considered severe enough to prevent a person 
from doing any gainful activity, or for a child claiming SSI payments 
under title XVI, that causes marked and severe functional limitations. 
We will revise these sections to ensure that the medical evaluation 
criteria are up-to-date and consistent with the latest advances in 
medical knowledge and treatment. The SSI program incorporates and uses 
the same medical criteria as the old-age, survivors, and disability 
insurance program.


Statement of Need:


These regulations are necessary because the current rules are now over 
ten years old. These rules will update the medical criteria and provide 
more information about how we evaluate cardiovascular impairments. They 
ensure that determinations of disability have a sound medical basis, 
that claimant receive equal treatment through the use of specific 
criteria, and that individuals 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 proposing only some of the 
revisions. However, we believe that all of these revisions are 
necessary because of the medical advances that have been made in 
treating and evaluating these types of impairments. These revisions 
also provide more information for our adjudicators to aid them in the 
evaluation of cardiovascular impairments; a number of the changes 
codify in our regulations guidance we have already provided to our 
adjudicators in other instruction we provided after we published the 
current rules.


Anticipated Cost and Benefits:


We anticipate that when finalized, these rules will result in 
negligible program and administrative costs.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            09/16/04                    69 FR 55874
NPRM Comment Period End         11/15/04
Final Action                    12/00/05

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


None


Agency Contact:
Bonnie Davis
Social Insurance Specialist
Social Security Administration
Office of Disability Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-4172

Fran O. Thomas
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-9822
RIN: 0960-AF48

[[Page 64291]]

_______________________________________________________________________



SSA



156. RULES FOR HELPING BLIND AND DISABLED INDIVIDUALS ACHIEVE SELF-
SUPPORT (506F)

Priority:


Other Significant


Legal Authority:


42 USC 1383b(d)


CFR Citation:


20 CFR 416.1180; 20 CFR 416.1181; 20 CFR 416.1226


Legal Deadline:


None


Abstract:


We will amend our regulations to explain how we implement section 203 
of the Social Security Independence and Program Improvements Act of 
1994 (Public Law 103-296). Section 203 of this law amended section 1633 
of the Social Security Act to require us to establish by regulations 
criteria for time limits and other criteria related to plans to achieve 
self-support (PASS). The law requires that the time limits take into 
account the length of time that a person needs to achieve his or her 
occupational goal, within a reasonable period, and other factors as 
determined by the Commissioner to be appropriate.


Statement of Need:


This regulation is necessary to implement the changes in section 1633 
of the Social Security Act regarding time limits and other criteria 
deemed necessary by the Commissioner.


Summary of Legal Basis:


42 U.S.C. 1383b authorizes the Commissioner to promulgate regulations 
for the purpose of establishing criteria for time-limits and other 
criteria deemed necessary related to the PASS program.


Alternatives:


None.


Anticipated Cost and Benefits:


We estimate that the administrative impact would be negligible.


Risks:


At this time we have not identified any risks associated with this 
proposal.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            07/11/05                    70 FR 39689
NPRM Comment Period End         09/09/05
Final Action                    04/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Mary Hoover
Social Insurance Specialist
Social Security Administration
Office of Program Development and Research
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-5651

Fran O. Thomas
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-9822
Related RIN: Previously reported as 0960-AE17
RIN: 0960-AG00
_______________________________________________________________________



SSA



157. MEDICARE PART D SUBSIDIES (1024F)

Priority:


Other Significant


Legal Authority:


PL 108-173; 42 USC 405; 42 USC 902(a)(5); 42 USC 1395w-101; 42 USC 
1395w-114; 42 USC 1395w-115


CFR Citation:


20 CFR 418.3001 (new); 20 CFR 418.3005 (new); 20 CFR 418.3010 (new); 20 
CFR 418.3101 (new); 20 CFR 418.3105 (new); 20 CFR 418.3110 (new); 20 
CFR 418.3115 (new); 20 CFR 418.3120 (new); 20 CFR 418.3123 (new); 20 
CFR 418.3125 (new); 20 CFR 418.3201 (new); 20 CFR 418.3205 (new); 20 
CFR 418.3210 (new); 20 CFR 418.3215 (new); 20 CFR 418.3220 (new); 20 
CFR 418.3225 (new); 20 CFR 418.3230 (new); 20 CFR 418.3301 (new); 20 
CFR 418.3305 (new); 20 CFR 418.3310 (new); 20 CFR 418.3315 (new); 20 
CFR 418.3320 (new); 20 CFR 418.3325 (new); 20 CFR 418.3330 (new); 20 
CFR 418.3335 (new); 20 CFR 418.3340 (new); 20 CFR 418.3345 (new); 20 
CFR 418.3350 (new); 20 CFR 418.3401 (new); 20 CFR 418.3405 (new); 20 
CFR 418.3410 (new); 20 CFR 418.3415 (new); 20 CFR 418.3420 (new); 20 
CFR 418.3425 (new); 20 CFR 418.3501 (new); 20 CFR 418.3505 (new); 20 
CFR 418.3510 (new); 20 CFR 418.3515 (new); 20 CFR 418.3601 (new); 20 
CFR 418.3605 (new); 20 CFR 418.3610 (new); 20 CFR 418.3615 (new); 20 
CFR 418.3620 (new); 20 CFR 418.3625 (new); 20 CFR 418.3630 (new); 20 
CFR 418.3635 (new); 20 CFR 418.3640 (new); 20 CFR 418.3645 (new); 20 
CFR 418.3650 (new); 20 CFR 418.3655 (new); 20 CFR 418.3665 (new); 20 
CFR 418.3670 (new); 20 CFR 418.3675 (new); 20 CFR 418.3680 (new)


Legal Deadline:


None


Abstract:


We will add to our regulations a new part 418 to contain rules that we 
will apply when we evaluate applications for premium and cost-sharing 
subsidies under the Medicare program. We will include a new subpart D, 
Medicare part D Subsidies, to this part. This new subpart will contain 
the rules that we use to determine eligibility for premium and cost-
sharing subsidies under the Medicare part D program, which was added by 
the Medicare Prescription Drug, Improvement, and Modernization Act of 
2003. (Medicare part D is a program for voluntary prescription drug 
coverage effective January 1, 2006.) These final rules will describe: 
What the new subpart is about; how we determine whether you are 
eligible for premium and cost-sharing subsidies; how we redetermine 
your eligibility for a subsidy; how you apply for a subsidy; how we 
evaluate your income and resources; when your eligibility for premium 
and cost-sharing subsidies terminates; how you may report changes in 
your circumstances; and how you can appeal a determination we make 
under the part D subsidy program.


Statement of Need:


SSA is responsible for determining premium and cost-sharing subsidy 
eligibility for the new Medicare Prescription Drug Benefit. The 
provision will be implemented in January 2006.


Summary of Legal Basis:


Section 1860D-14 of the Social Security Act provides for premium and 
cost-sharing subsidies for certain low-income individuals, and directs 
the Social Security Administration to develop a simplified application 
process.


Alternatives:


None.

[[Page 64292]]

Anticipated Cost and Benefits:


The Centers for Medicare and Medicaid Services (CMS) has developed 
detailed cost estimates for implementation of the Prescription Drug 
Benefits program. These costs are explained in a CMS Notice of Proposed 
Rulemaking (CMS-4068P; 69 FR 46632; 08/03/2004). The administrative 
costs are estimated to be about $1 billion over the 5-year period from 
fiscal year (FY) 2004 through FY 2008. The benefit of developing agency 
regulations for a simplified subsidy application are that many 
beneficiaries with incomes below 150 percent of the poverty level, and 
limited resources, will be able to get help with paying premiums and 
cost-sharing for Medicare part D coverage.


Risks:


There are inherent risks in any form of public benefit which requires 
means-testing. The risks for the prescription drug benefit premium and 
cost-sharing subsidy program are increased by the requirement that SSA 
use a simplified application process.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/04/05                    70 FR 10558
NPRM Comment Period End         05/03/05
Final Action                    01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


None


Agency Contact:
Craig Streett
Social Insurance Specialist
Social Security Administration
Office of Income Security Programs
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-9793

Lois A. Berg
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-1713
RIN: 0960-AG03
_______________________________________________________________________



SSA



158. CIVIL MONETARY PENALTIES, ASSESSMENTS, AND RECOMMENDED EXCLUSIONS 
(2362F)

Priority:


Other Significant


Legal Authority:


42 USC 902(a)(5); 42 USC 1320a-8; 42 USC 1320b-10


CFR Citation:


20 CFR 498.100 TO 498.104; 20 CFR 498.106; 20 CFR 498.109; 20 CFR 
498.114; 20 CFR 498.128


Legal Deadline:


None


Abstract:


These final regulations will amend the existing regulations for the 
implementation of section 1129 of the Social Security Act (42 U.S.C. 
1320a-8) to:


(1) Reflect the expanded authority under section 1129 to impose a civil 
monetary penalty and assessment, as applicable, for fraud or similar 
fault involved in the receipt of benefits under title VIII of the 
Social Security Act; and (2) add as new categories for civil monetary 
penalty and assessment under section 1129 (i) representative payees 
with respect to wrongful conversion, and (ii) individuals who withhold 
the disclosure of material facts to the SSA if the person knows or 
should know that withholding of such disclosure is misleading.


These final regulations will also amend the existing regulations for 
the implementation of section 1140 of the Social Security Act (42 
U.S.C. 1320b-10) to: (1) Require an advertiser or direct marketer who 
offers to assist an individual in obtaining products or services for a 
fee, that SSA otherwise provides free of charge, to include a written 
notice on the solicitation/mailing that the product or service is 
available from SSA free of charge; and (2) expand the list of terms in 
section 1140 that encompass the scope of words or phrases that the 
statute prohibits from being used in a misleading manner.


Statement of Need:


These final regulations are necessary to reflect and implement the 
amendments to sections 1129 and 1140 of the Social Security Act (42 
U.S.C. 1320A-8 and 42 U.S.C. 1320b-10) made by Public Laws 106-169 and 
108-203.


Summary of Legal Basis:


These final regulations will reflect and implement section 251(b)(6) of 
Public Law 106-169 and sections 111, 201, 204, and 207 of Public Law 
108-203.


Alternatives:


None.


Anticipated Cost and Benefits:


Cost--The administrative cost impact of this rule is attributable to 
enacted legislation and not to the regulation itself, and will be 
negligible (i.e., less than $2 million or 25 workyears).


Benefits--These final regulations are intended to enhance our program 
integrity efforts.


Risks:


None.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            03/23/05                    70 FR 14603
NPRM Comment Period End         05/23/05
Final Action                    01/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


Businesses


Government Levels Affected:


None


Agency Contact:
Kathy Buller
Chief Counsel to the Inspector General
Social Security Administration
Office of the Inspector General
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 965-2827

Fran O. Thomas
Social Insurance Specialist
Social Security Administration
Office of Regulations
6401 Security Boulevard
Baltimore, MD 21235-6401
Phone: 410 966-9822
RIN: 0960-AG08
BILLING CODE 4191-02-S

[[Page 64293]]




CONSUMER PRODUCT SAFETY COMMISSION (CPSC)



Statement of Regulatory Priorities
The U.S. Consumer Product Safety Commission is charged with protecting 
the public from unreasonable risks of death and injury associated with 
consumer products. To achieve this goal, the Commission:
 participates in the development or revision of voluntary 
            product safety standards;
 develops mandatory product safety standards or banning rules 
            when other, less restrictive, efforts are inadequate to 
            address a safety hazard;
 obtains repair, replacement, or refund of the purchase price 
            for defective products that present a substantial product 
            hazard; and
 develops information and education campaigns about the safety 
            of consumer products.
When deciding which of these approaches to take in any specific case, 
the Commission gathers the best available data about the nature and 
extent of the hazard presented by the product. The Commission then 
analyzes this information to determine the best way to reduce the 
hazard in each case. The Commission's rules require the Commission to 
consider, among other factors, the following criteria when deciding the 
level of priority for any particular project:
 frequency and severity of injury;
 causality of injury;
 chronic illness and future injuries;
 costs and benefits of Commission action;
 unforeseen nature of the risk;
 vulnerability of the population at risk;
 probability of exposure to the hazard.
Additionally, if the Commission proposes a mandatory safety standard 
for a particular product, the Commission is generally required to make 
statutory cost/benefit findings and adopt the least burdensome 
requirements that adequately protect the public.
The Commission's statutory authority requires it to rely on voluntary 
standards rather than mandatory standards whenever a voluntary standard 
is likely to result in the elimination or adequate reduction of the 
risk of injury and it is likely that there will be substantial 
compliance with the voluntary standard. As a result, much of the 
Commission's work involves cooperative efforts with other participants 
in the voluntary standard-setting process rather than promulgating 
mandatory standards.
In fiscal year 2006, the Commission's significant rulemaking activities 
will involve addressing risks of fire associated with ignition of 
upholstered furniture and of mattresses and bedding. The emphasis on 
this rulemaking activity in the Commission's FY 2006 regulatory plan is 
consistent with the Commission's statutory mandate and its criteria for 
setting priorities.
_______________________________________________________________________



CPSC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




159. FLAMMABILITY STANDARD FOR UPHOLSTERED FURNITURE

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


15 USC 1193, Flammable Fabrics Act; 5 USC 801


CFR Citation:


16 CFR 1640


Legal Deadline:


None


Abstract:


On June 15, 1994, the Commission published an advance notice of 
proposed rulemaking (ANPRM) to begin a proceeding for development of a 
flammability standard to address risks of death, injury, and property 
damage from fires associated with ignition of upholstered furniture by 
small open-flame sources such as matches, lighters, or candles. CPSC 
staff conducted research and developed a draft flammability performance 
standard. The draft standard was first presented to stakeholders at a 
1996 ASTM voluntary standards meeting. The staff also worked with 
industry and voluntary standards groups to develop possible 
alternatives to a Federal rule.


In 1998, the Commission held a public hearing to gather additional 
information beyond that available to the agency on the potential 
toxicity, health risks, and environmental effects associated with 
flame-retardant chemicals that might be used to meet a standard. In 
CPSC's 1999 appropriations legislation, Congress directed the 
Commission to contract with the National Academy of Sciences (NAS) for 
an independent study of potential health hazards associated with the 
use of flame retardant chemicals that might be used in upholstered 
furniture fabrics to meet a CPSC standard. The final NAS report was 
published in July 2000. The report concluded that of 16 flame-retardant 
chemicals reviewed, 8 could be used in upholstered furniture fabrics 
without presenting health hazards to consumers.


In 2002, the staff held a public meeting to receive any new technical 
information and recommendations from interested parties on the project. 
In 2003, the staff forwarded a package to the Commission analyzing the 
information received at the meeting and a package recommending that the 
Commission expand its proceeding to cover both small open flame and 
cigarette ignition risks.


On October 23, 2003, the Commission issued a new ANPRM expanding the 
scope of the proceeding to include both cigarette and small open flame-
ignited fire risks. The staff held a public meeting to discuss public 
comments on April 9, 2004. The staff developed revised drafts of the 
standard addressing both cigarette and small open flame ignition, and 
held public meetings on October 28, 2004 and May 18, 2005 to present 
and discuss the revised drafts. The staff is currently analyzing 
comments and preparing alternatives for Commission consideration.


CPSC is also considering possible impacts of flame-retardant chemical 
use on worker safety and the environment. At the CPSC staff's request, 
the National Institute for Occupational Safety and Health studied 
potential worker exposure to and risks from certain flame-retardant 
chemicals that may be used by textile and furniture producers to comply 
with an upholstered furniture flammability standard. NIOSH 
preliminarily concluded that significant worker health effects were 
unlikely. CPSC staff is also working with the Environmental Protection 
Agency to (a) develop a significant new use rule (SNUR) for flame-
retardant compounds used in residential upholstered furniture fabrics 
under that agency's Toxic Substances Control Act Authority, and (b) 
identify and encourage the use of environmentally-friendly flame 
retardants under a Design for the Environment industry/government 
partnership.

[[Page 64294]]

Statement of Need:


For 1995-1999, an annual average of approximately 6,600 residential 
fires in which upholstered furniture was the first item to ignite 
resulted in an estimated 460 deaths, 1,110 civilian injuries, and about 
$130 million in property damage that could be addressed by a 
flammability standard. The total annual societal cost attributable to 
these upholstered furniture fire losses was approximately $2.75 
billion. This total includes fires ignited by small open-flame sources 
and cigarettes.


Summary of Legal Basis:


Section 4 of the Flammable Fabrics Act (FFA) (15 U.S.C. 1193) 
authorizes the Commission to issue a flammability standard or other 
regulation for a product of interior furnishing if the Commission 
determines that such a standard is ``needed to adequately protect the 
public against unreasonable risk of the occurrence of fire leading to 
death or personal injury, or significant property damage.'' The 
Commission's regulatory proceeding could result in several actions, one 
of which could be the development of a mandatory standard requiring 
that upholstered furniture sold in the United States meet mandatory 
labeling requirements, resist ignition, or meet other performance 
criteria under test conditions specified in the standard.


Alternatives:


(1) The Commission could issue a mandatory flammability standard if the 
Commission finds that such a standard is needed to address an 
unreasonable risk of the occurrence of fire from ignition of 
upholstered furniture; (2) The Commission could issue mandatory 
requirements for labeling of upholstered furniture, in addition to, or 
as an alternative to, the requirements of a mandatory flammability 
standard; and (3) The Commission could terminate the proceeding for 
development of a flammability standard and rely on a voluntary standard 
if a voluntary standard would adequately address the risk of fire and 
substantial compliance with such a standard is likely to result.


Anticipated Cost and Benefits:


The estimated annual cost of imposing a mandatory standard to address 
ignition of upholstered furniture will depend upon the test 
requirements imposed by the standard and the steps manufacturers take 
to meet those requirements. Again, depending upon the test 
requirements, a standard may reduce cigarette and small open flame-
ignited fire losses, the annual societal cost of which was $2.75 
billion for 1995-1999. Thus, the potential benefits of a mandatory 
standard to address the risk of ignition of upholstered furniture could 
be significant, even if the standard did not prevent all such fires.


Risks:


The estimated average annual cost to society from all residential fires 
associated with upholstered furniture was $2.75 billion for 1995-1999. 
Societal costs associated with upholstered furniture fires are among 
the highest associated with any product subject to the Commission's 
authority. A standard has the potential to reduce these societal costs.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           06/15/94                    59 FR 30735
ANPRM Comment Period End        08/15/94
Staff Briefing of 
    Commission on NPRM          12/18/97
Commission Voted To Defer 
    Action Pending 
    Results of Toxicity 
    Hearing                     03/02/98
Commission Hearing May 5 
    & 6, 1998 on Possible 
    Toxicity of Flame 
    Retardant Chemicals         03/17/98                    63 FR 13017
NAS Study Completed 
    (Required by 
    Congress)                   07/10/00
Staff Sent Briefing 
    Package to Commission       11/01/01
Meeting Notice                  03/20/02                    67 FR 12916
Staff Held Public Meeting       06/18/02
Second Day of Public 
    Meeting                     06/19/02
Staff Sent Analysis of 
    Information From 
    Public Meeting to the 
    Commission                  02/06/03
Staff Sent Regulatory 
    Options to Commission       07/12/03
Notice of September 24 
    Public Meeting              08/27/03                    68 FR 51564
Commission Decision             10/17/03
ANPRM                           10/23/03                    68 FR 60629
ANPRM Comment Period End        12/22/03
Staff Held Public Meeting       10/28/04
Staff Held Public Meeting       05/18/05
Staff Sends Briefing 
    Package to Commission       01/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Dale R. Ray
Project Manager
Consumer Product Safety Commission
Directorate for Economic Analysis
Washington, DC 20207
Phone: 301 504-7704
Email: [email protected]
RIN: 3041-AB35
_______________________________________________________________________



CPSC

                              -----------

                            FINAL RULE STAGE

                              -----------




160. PROPOSED STANDARD TO ADDRESS OPEN-FLAME IGNITION OF MATTRESSES/
FOUNDATION SETS

Priority:


Economically Significant. Major under 5 USC 801.


Legal Authority:


15 USC 1193, Flammable Fabrics Act; 5 USC 801


CFR Citation:


16 CFR 1633


Legal Deadline:


None


Abstract:


On October 11, 2001, the Commission published an advance notice of 
proposed rulemaking (ANPRM) to begin a proceeding for development of a 
flammability standard to address risks of death, injury, and property 
damage from fires associated with ignition of mattresses/bedding by 
small open-flame sources such as lighters, candles, or matches. This 
ANPRM was issued after the Commission staff conducted a field 
investigation study of these incidents and worked with industry members 
to improve consumer information programs and conducted research to 
define and measure the fire hazard presented by mattress/bedding 
ignitions in residential fires.


The Commission also received four petitions from the Children's 
Coalition for Fire-Safe Mattresses proposing: (1)

[[Page 64295]]

an open flame standard similar to the full-scale test set forth in 
California Technical Bulletin 129; (2) an open flame standard similar 
to the component test set forth in British Standard 5852; (3) a warning 
label for mattresses warning of polyurethane foam fire hazards; and (4) 
a permanent, fire-proof mattress identification tag. The Commission 
granted the first two petitions and denied the others.


The Commission staff reviewed public comments on the ANPRM and 
continued working with the Sleep Products Safety Council (representing 
manufacturers and suppliers to the industry), the National Institute of 
Standards and Technology, the State of California Bureau of Home 
Furnishings, and others to complete the development of an appropriate 
test method and criteria for a standard to address open flame ignition 
of mattresses. In 2004, the staff prepared a decision package for 
Commission consideration, including a draft proposed standard with 
supporting materials, draft notice of proposed rulemaking (NPRM), and 
possible options to separately address the bedclothes contribution to 
mattress fires. On December 22, 2004, the Commission voted to publish 
the NPRM for mattresses (and to separately address bedclothes by 
publishing an ANPRM for bedclothes). The staff will evaluate public 
comments received on the NPRM and prepare a briefing package for 
Commission decision on publishing a final mattress standard.


Statement of Need:


Based on national fire estimates for the years 1995-1999, ignition of 
mattresses and bedding resulted in an estimated 18,500 residential 
fires, 440 civilian deaths, 2,160 civilian injuries, and $259.5 million 
in property loss annually that could be addressed by a flammability 
standard. Since mattress fires often involve the ignition source of 
burning bedding, initially ignited by a smaller source, a standard 
incorporating an ignition source representing burning bedding could 
address deaths and injuries from these fires.


Summary of Legal Basis:


Section 4 of the Flammable Fabrics Act (FFA) (15 U.S.C. 1193) 
authorizes the Commission to issue a flammability standard or other 
regulation for a product of interior furnishing if the Commission 
determines that such a standard is ``needed to adequately protect the 
public against unreasonable risk of the occurrence of fire leading to 
death or personal injury, or significant property damage.'' The 
Commission's regulatory proceeding could result in the development of a 
mandatory standard requiring that mattresses sold in the United States 
meet mandatory labeling requirements and performance criteria limiting 
the size of the fire produced when a mattress is exposed to a large 
ignition source representing burning bedclothes.


Alternatives:


(1) The Commission could issue a mandatory flammability standard if the 
Commission finds that such a standard is needed to address an 
unreasonable risk of the occurrence of fire from ignition of 
mattresses;


(2) The Commission could issue mandatory requirements for labeling of 
mattresses, in addition to, or as an alternative to, the requirements 
of a mandatory flammability standard; or


(3) The Commission could terminate the proceeding for development of a 
flammability standard and rely on a voluntary standard if a voluntary 
standard would adequately address the risk of fire and substantial 
compliance with such a standard is likely to result.


Anticipated Cost and Benefits:


The estimated annual cost of imposing a mandatory standard to address 
ignition of mattresses by open-flame sources will depend upon the 
performance requirements imposed by the standard and the steps 
manufacturers take to meet those requirements. A standard incorporating 
an ignition source representing burning bedclothes could address deaths 
and injuries from fires caused by smoking materials, traditional small 
open flame sources, as well as other heat sources.


Risks:


The estimated total cost to society from all residential fires 
associated with mattresses/bedding was about $3 billion in 1999. 
Societal costs associated with mattress/bedding fires are among the 
highest associated with any product subject to the Commission's 
authority. A standard has the potential to reduce these societal costs.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
ANPRM                           10/11/01                    66 FR 51886
ANPRM Comment Period End        12/10/01
Staff Sends Briefing 
    Package to Commission       11/01/04
Staff Briefs Commission 
    on NPRM Draft               12/09/04
Commission Decision             12/22/04
NPRM                            01/13/05                     70 FR 2470
Public Hearing                  03/03/05
NPRM Comment Period End         03/29/05
Staff Sends Briefing 
    Package to Commission       01/00/06

Regulatory Flexibility Analysis Required:


Undetermined


Government Levels Affected:


Undetermined


Federalism:


 Undetermined


Agency Contact:
Margaret L. Neily
Project Manager
Consumer Product Safety Commission
Directorate for Engineering Sciences
Washington, DC 20207
Phone: 301 504-7530
Email: [email protected]
RIN: 3041-AC02
BILLING CODE 6355-01-S

[[Page 64296]]




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 2006 that would be required to be included in a 
regulatory plan.
The Finance Board's highest regulatory priorities during 2006 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:
 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;
 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;
 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;
 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.
 Streamline the regulations governing the Banks' acquired 
            member asset programs, to make the provisions less 
            prescriptive while preserving the key provisions relating 
            to safety and soundness and advancement of the Banks' 
            housing finance mission.
 Update the regulations relating to the capital structure of 
            the Banks to enhance their safety and soundness by ensuring 
            that the amount and composition of their capital is 
            appropriate in light of the risks undertaken in the course 
            of their lines of business.
 Improve the regulations relating to the investments made by 
            the Banks to coordinate with the repeal of the provisions 
            of the Financial Management Policy that currently govern 
            Bank investment portfolios.
BILLING CODE 6725-01-S

[[Page 64297]]




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 vision. The Commission's vision is to 
administer the shipping statutes as effectively as possible to provide 
fairness and efficiency in the United States maritime commerce. The 
Commission's regulations are designed to implement each of the statutes 
the Agency administers in a manner consistent with this vision in a way 
that minimizes regulatory costs, fosters economic efficiencies, and 
promotes international harmony.
 The Ocean Shipping Reform Act of 1998 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. The Commission continues 
to assess its regulations implementing this legislation.
 The Commission is presently in the process of a comprehensive review 
of Commission rules and regulations to ensure alignment with emerging 
industry trends and business practices, particularly as they relate to 
ocean transportation intermediaries and vessel-operating common 
carriers. It is likely that proposals for change to certain Commission 
regulations will come from that examination.
 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 received a number of comments in response 
to its rulemaking proposal to update the nonperformance coverage 
requirements to correspond more closely with current industry 
conditions. Included among these submissions is a request that the 
Commission consider a report providing an update on developments in the 
industry. The Commission is continuing its review of this request as 
well as the other matters submitted in this proceeding.
 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 also receives requests from the public seeking new 
regulations or modifications of existing regulations. If circumstances 
so warrant, the Commission on its own initiative, or upon request, will 
institute an appropriate rulemaking proceeding.
 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 64298]]




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. Fraud 
and deception injure both consumers and honest competitors alike and 
undermine competitive markets. Through its consumer protection 
activities, the Commission seeks to ensure that consumers receive 
accurate, truthful, and non-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.
Industry Self-Regulation and Compliance Partnerships With Industry
 The Commission continues to be committed to protecting consumers 
through a variety of tools including both regulatory and non-regulatory 
approaches. 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 held workshops and issued reports that encourage 
industry self-regulation in several areas. Privacy, information 
security, and information sharing continue to be at the forefront of 
the Commission's consumer protection program:
1. During November 2004, the Commission convened an E-mail 
            Authentication Summit, co-sponsored by the National 
            Institute of Standards and Technology at the Commerce 
            Department. Since then, the Commission has been encouraging 
            the development of a compatible authentication standard 
            that would provide accountability for email communication.
2. The Commission also explored the consumer protection and privacy 
            implications of Radio Frequency Identification (RFID) at a 
            public forum and subsequently published a staff report 
            recommending that industry initiatives that are transparent 
            could play an important role in addressing privacy concerns 
            raised by certain RFID applications. See RFID: Radio 
            Frequency IDentification: Applications and Implications for 
            Consumers: A Workshop Report From the Staff of the Federal 
            Trade Commission (March 2005), available at http://
www.ftc.gov/os/2005/03/050308rfidrpt.pdf. The report also 
            recommended that industry self-regulatory programs should 
            include meaningful accountability provisions to help ensure 
            compliance.
3. The Commission held a 2004 public workshop on spyware--which can 
            surreptitiously install itself on a personal computer and 
            wreak havoc--and released a staff workshop report 
            concluding in part that industry should develop standards 
            for defining spyware and disclosing information about it to 
            consumers, expand efforts to educate consumers about 
            spyware risks and help law enforcement efforts. See Spyware 
            Workshop: Monitoring Software On Your Personal Computer: 
            Spyware, Adware, and Other Software Staff Report Federal 
            Trade Commission (March 2005), available at http://
www.ftc.gov/os/2005/03/050307spywarerpt.pdf.
4. The Commission has also undertaken efforts to educate consumers 
            about the risks associated with downloading and using peer-
            to-peer file-sharing software programs. A March 2005 
            ``Cyber Security Tip'' warns consumers that use of such 
            technology presents a number of risks, including the 
            installation of malicious code, exposure of sensitive or 
            personal information, susceptibility of the consumer's 
            computer to attack, and exposure to legal liability. In a 
            June 2005 report, the FTC staff encouraged implementation 
            of industry proposals regarding risk disclosures and will 
            continue to monitor this area. See Peer-to-Peer File-
            Sharing Technology: Consumer Protection and Competition 
            Issues Staff Report Federal Trade Commission (June 2005), 
            available at http://www.ftc.gov/reports/p2p05/
050623p2prpt.pdf.
5. With respect to the Children's Online Privacy Protection Act 
            (COPPA), the Commission has approved the safe harbor 
            programs of four organizations whose self-regulatory 
            guidelines and programs protect children's privacy to the 
            same or greater extent as COPPA. The organizations with 
            these programs include the Children's Advertising Review 
            Unit of the Council of Better Business Bureaus (CARU), an 
            arm of the advertising industry's self-regulatory program; 
            the Entertainment Software Rating Board (ESRB); TRUSTe, an 
            Internet privacy seal program; and Privo, Inc.
 Additionally, in the entertainment industry, the Commission has 
encouraged industry groups to improve their self-regulatory programs to 
discourage the marketing to children of violent R-rated movies, Mature-
rated electronic games, and music labeled with a parental advisory. The 
motion picture, electronic game and music industries have each set in 
place a self-regulatory system that rates or labels products in an 
effort to help parents seeking to limit their children's exposure to 
violent materials. Since 1999, the Commission has issued five reports 
on these three industries, examining compliance with their own 
voluntary marketing guidelines. In 2004,

[[Page 64299]]

the Commission issued the latest of a series of reports on industry 
practices. The Commission's review reveals that the movie and game 
industries continue to comply, for the most part, with their self-
regulatory limits on ad placement, although the Commission found that 
violent R-rated movies and M-rated games were still being advertised in 
media with large teen audiences. The recording industry is an example 
of a less successful self-regulatory attempt. The Commission 
recommended in its latest report that all three industries continue to 
improve compliance with existing ad placement guidelines and rating 
information practices and consider developing `best practices' to avoid 
advertising in venues popular with teen audiences. The Commission also 
noted that there remained room for improvement in retailers' practices 
because the Commission found that teens could still purchase rated or 
labeled entertainment products at a significant number of stores and 
theaters, even though the movie theater industry has made real progress 
in this area, and to a lesser extent so have game retailers. See 
Federal Trade Commission, Marketing Violent Entertainment to Children: 
A Fourth Follow-Up Review of Industry Practices in the Motion Picture, 
Music Recording & Electronic Game Industries A Report to Congress (July 
2004), http://www.ftc.gov/os/2004/07/040708kidsviolencerpt.pdf. Most 
recently, the Commission has issued consumer education materials to 
assist parents in understanding video game ratings.
 The Commission also supports the actions of three alcohol industry 
trade associations, the Distilled Spirits Council of the United States, 
the Beer Institute, and the Wine Institute, to develop and implement 
voluntary advertising codes governing the placement and content of 
alcohol advertising. In particular, 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. The Commission has worked and will 
continue to work with industry to facilitate compliance with the 
improved self-regulatory standards announced in the FTC's report, 
Federal Trade Commission, Alcohol Marketing and Advertising A Report to 
Congress (Sept. 2003), available at http://ftc.gov/os/2003/09/
alcohol08report.pdf.
 In addition, in the weight loss product advertising area, the 
Commission has consistently proposed a strengthened self-regulatory 
response from the industry and more media responsibility to address the 
widespread problem of blatantly false efficacy claims. Specifically, 
the Commission authorized the release of a media reference guide to 
assist media in identifying facially false weight-loss claims. Federal 
Trade Commission Staff, Red Flag: A Reference Guide for Media on Bogus 
Weight Loss Claim Detection (2003), available at: http://www.ftc.gov/
bcp/online/pubs/buspubs/redflag.pdf. The Commission asked the media to 
refuse to run advertisements that make ``Red Flag'' claims. The media 
appears to be responding to this challenge, as shown by a follow-up 
report that analyzed data gathered during 2004. See 2004 Weight Loss 
Advertising Survey Staff Report Federal Trade Commission (April 2005), 
available at http://www.ftc.gov/os/2005/04/
050411weightlosssurvey04.pdf. The FTC's survey of weight loss 
advertisements found that the number of ads with red flag claims had 
fallen from almost 50% to 15%. In addition, the FTC has supported a 
joint effort by the Electronic Retailing Association and the Better 
Business Bureau's National Advertising Review Council to develop a 
self-regulatory, rapid review process, the Electronic Retailing Self-
Regulation Program, that could promptly address deceptive infomercial 
claims.
In a related area, the Commission and the Department of Health and 
Human Services (HHS) jointly sponsored a workshop during June 2005 that 
examined marketing, self-regulation, and childhood obesity (materials 
are available at http://www.ftc.gov/bcp/workshops/foodmarketingtokids/
). The workshop brought together a wide range of speakers to examine 
ways, including self-regulation, to best promote competition among 
marketers of healthy foods and the dissemination of good information so 
that consumers can make healthy food choices.
 Finally, the Commission continues to apply 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 correcting (through 
relabeling) inadvertent labeling errors that are not likely to cause 
injury to consumers. Since the Textile Corporate Leniency Program was 
announced, 50 companies have been granted ``leniency'' for self-
reported minor violations of FTC textile regulations.
 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, conducted 
in partnership with the National Funeral Directors Association, 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 226 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 teaches 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, 
seventeen companies have agreed to participate in the program.
Rulemakings Required by Statute
 In 2003, the Congress enacted several laws requiring the Commission to 
undertake rulemakings and studies. These include at least 25 new 
rulemakings and eight studies required by the Fair and Accurate Credit 
Transactions Act of 2003, Pub. L. No. 108-159 (FACTA or the FACT Act); 
the rulemakings and reports required by the Controlling the Assault of 
Non-Solicited Pornography and Marketing Act of 2003, Pub. L. No. 108-
187 (CAN-Spam Act); and the rulemaking pursuant to the Federal Deposit 
Insurance Corporation Improvements Act of 1991, Pub. L. 102-242. These 
rulemakings are proceeding according to schedule and are detailed more 
extensively in the Unified Agenda. The Final Actions section below 
describes any final actions taken on these rulemakings.

[[Page 64300]]

On August 8, 2005, the President signed the Energy Policy Act of 2005, 
which requires the Commission to complete two rulemakings while 
authorizing other discretionary rulemaking actions. Pursuant to this 
statute the Commission is required to initiate a rulemaking within 90 
days of enactment examining the effectiveness of the energy efficiency 
related consumer product labeling program. Further, the Commission is 
required to complete this rulemaking within two years of enactment. The 
statute also requires the Commission to issue labeling requirements for 
ceiling fans concerning the electricity used by the fans to circulate 
air in a room. The statute also amends the statutory definitions of 
some covered lighting products that may require the Commission to make 
conforming amendments to the current rule. The statute also authorizes 
the Commission or the Secretary of the Department of Energy (DOE), as 
appropriate, to require labels for a number of products. The Commission 
and DOE are consulting about how to proceed in this area. Another 
section of the Act gives the Commission discretionary authority to 
issue retail electricity rules related to slamming (unauthorized 
account switches), cramming (unauthorized charges), and privacy.
Other New Regulatory Activities
 After issuing a staff advisory opinion indicating that the 
Commission's current Guides for Jewelry, Precious Metals and Pewter 
Industries, 16 CFR part 23, did not address descriptions of new 
platinum alloy products, the Commission issued a Request for Public 
Comments on whether the platinum section of the Guides for Jewelry, 
Precious Metals and Pewter Industries should be amended to provide 
guidance on how to non-deceptively mark or describe products containing 
between 500 and 850 parts per thousand pure platinum and no other 
platinum group metals. 70 FR 38834 (July 6, 2005). The comment period 
closed on October 12, 2005.
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 601-612. 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.'' 5 USC 610. The program's goal is to ensure 
that all of the Commission's rules and guides remain beneficial and in 
the public interest. It complies with the Small Business Regulatory 
Enforcement Act of 1996, Pub. L. 104-121. This program is consistent 
with the Administration's ``smart'' regulation agenda to streamline 
regulations and reporting requirements and Section 5(a) of Executive 
Order 12866, 58 FR 51735 (Sept. 30, 1993).
 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 57 percent of its 
guides since 1992.
Calendar Year 2005 Reviews
 All of the matters currently under review pertain to consumer 
protection and are intended to ensure that consumers receive the 
information necessary to evaluate competing products and make informed 
purchasing decisions. During early 2005, the Commission announced its 
ten-year schedule of review and that it would initiate the review of 
two rules during 2005: (1) the Deceptive Advertising as to Sizes of 
Viewable Pictures Shown by Television Receiving Sets Rule (the Picture 
Tube Rule), 16 CFR part 410, and (2) the Children's Online Privacy 
Protection Rule (COPPA Rule), 16 CFR part 312. 70 FR 2074 (Jan. 12, 
2005). On April 7, 2005, the Commission requested comments on the 
applicability and use of the Picture Tube Rule, particularly in light 
of an array of new types of televisions now available to consumers. 70 
FR 17623. The notice asked nine specific questions about the rule that 
the public may wish to address. The comment period ended on June 6, 
2005, and staff plans to forward its recommendation to the Commission 
in late 2005. A regulatory review of the COPPA rule was also required 
by the COPPA statute within five years after the rule became effective. 
On Apr. 22, 2005, the Commission requested comments about the 
implementation of the COPPA Rule. 70 FR 21107. The comment period ended 
on June 27, 2005, and staff plans to forward recommendations to the 
Commission by the end of 2005.
Ongoing Reviews
 It is expected that during 2006, the Commission will issue separate 
notices requesting comments both on the Statement of General Policy or 
Interpretations under the Fair Credit Reporting Act (also known as FCRA 
Commentary) and for the Guides Concerning the Use of Endorsements and 
Testimonials in Advertising. Other reviews are continuing.
 First, for the Telemarketing Sales Rule (TSR), 16 CFR part 310, the 
Commission published an NPRM on November 17, 2004, proposing to permit 
prerecorded message telemarketing when there is an established business 
relationship between the caller and a consumer as long as a consumer 
has the opportunity to make a do not call request at the outset of the 
message. At the same time, and in response to a request for 
reconsideration on the FTC's calculation of call abandonment rates on a 
daily basis, the NPRM also requested comments and factual information 
supporting a requested switch from the current policy of measuring the 
3% abandoned call ratio from a per day calculation to an average of 
calls abandoned over a 30-day period. The NPRM also stated that, 
pending completion of the rulemaking, the FTC would not enforce the 
TSR's current call abandonment provisions against callers who engage in 
prerecorded message telemarketing when there is an established business 
relationship provided they comply with the proposed requirements. The 
comment period closed on January 10, 2005, and staff anticipates 
forwarding its recommendation to the Commission by October 2005.
 Second, in the review of the Franchise Rule, 16 CFR part 436, the 
Commission announced on August 25, 2004, the issuance of a staff 
report, Disclosure Requirements and Prohibitions Concerning 
Franchising, which summarizes the rulemaking record to date, analyzes 
the various alternatives, and sets forth the staff's

[[Page 64301]]

recommendations to the Commission on the various proposed amendments to 
the Franchise Rule, 69 FR 53661 (Sept. 2, 2004). The Commission did not 
review or approve the staff report. Among other things, staff proposes 
that the Commission retain the Franchise Rule while updating it to 
account for new technologies and to provide prospective franchisees 
with more disclosure about the nature of the franchise relationship, 
while minimizing the discrepancies between Federal and State law. 
Public comments were accepted until November 12, 2004. Staff is 
reviewing the comments and anticipates sending its recommendation to 
the Commission by the end of 2005.
 Third, for the Hart-Scott-Rodino Premerger Notification Rules (HSR 
Rules), Bureau of Competition staff anticipates forwarding a 
recommendation to the Commission by the end of 2005 to update the base 
year used in Item 5 of the Premerger Notification Form Response from 
1997 to 2002. In addition, the Commission published an NPRM proposing 
to amend 16 CFR part 803 of the HSR Rules to address the issue of stale 
filings and to permit filing parties to provide Internet links to 
certain documents in lieu of paper copies. 70 FR 47733 (Aug. 15, 2005).
 Fourth, for the rulemaking on Privacy of Consumer Financial 
Information, 16 CFR part 313, the Commission and banking agencies 
published an ANPRM and requested public comments on a variety of 
subjects including the goals, language, and mandatory or permissible 
aspects of privacy notices. 68 FR 75164 (Dec. 30, 2003). Since the 
issuance of rules in 2000 in accordance with the Gramm-Leach-Bliley 
Act, 15 USC 6801 et seq., which requires that financial institutions 
provide notice of their privacy policies to their customers, the 
agencies have been trying to develop more useful privacy notices to 
consumers. The comment period for the ANPRM ended on March 26, 2004. 
Staff for the agencies are reviewing comments and continuing to work 
together to determine the next steps.
 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 ongoing. 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 in 2006.
 Sixth, the Commission began its regulatory review of certain aspects 
of the Funeral Industry Practices Rule (Funeral 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 state 
prices and descriptions and also contain specific disclosures. The rule 
enables consumers to select and purchase only the goods and services 
they want, except for those that 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. See 64 FR 24250 (May 5, 
1999). A public workshop conference was subsequently held to explore 
issues raised in the comments submitted. Staff expects to forward its 
recommendation to the Commission by the end of 2005.
 Finally, the Commission's review of the Pay-Per-Call Rule, 16 CFR part 
308, is continuing. 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 pre-subscription agreement, and the need for 
obtaining express authorization from consumers before placing charges 
on their telephone bills. Staff anticipates forwarding its 
recommendation to the Commission by early 2006.
Final Actions
 First, since publication of the 2004 Regulatory Plan, the Commission 
has taken final actions on several rulemakings. For the Children's 
Online Privacy Protection Rule (COPPA Rule), 16 CFR part 312, the 
Commission issued a final rule, 70 FR 21104, effective April 21, 2005, 
extending a previously published temporary e-mail verification 
provision until the conclusion of the Commission's rule review. That 
provision allows operators of websites and online services that collect 
personal information from children only for internal use to obtain 
verifiable parental consent via e-mail plus an additional step to 
verify that the person consenting is the child's parent.
 Second, the Commission is actively issuing rules required to implement 
the Fair and Accurate Credit Transactions Act (FACTA or Fact Act). 
These rulemakings are sometimes conducted in conjunction with other 
federal financial regulatory agencies.
1. The Commission issued final model notices on November 30, 2004, 69 
            FR 69776, summarizing consumers' identity theft rights and 
            mounting a public education campaign regarding consumers' 
            new identity theft rights.
2. The Commission published a Final Fraud Alerts Rule on November 3, 
            2004. 69 FR 63922. This rule defines certain terms that are 
            relevant to consumers' new identity theft rights including: 
            ``identity theft'' and ``identity theft report''; the 
            duration of an ``active duty alert''; and the ``appropriate 
            proof of identity'' for purposes of sections 605A (fraud 
            alerts and active duty alerts), 605B (consumer report 
            information blocks), and 609(a)(1) (truncation of Social 
            Security numbers) of the FCRA, as amended by the FACT Act.
3. The Commission, in consultation with the banking agencies and the 
            NCUA, published a final rule on January 31, 2005, that 
            enhances notices to consumers about their right to opt out 
            of prescreened solicitations. 70 FR 5022.
4. The Commission, in coordination with the banking agencies, NCUA, and 
            the SEC, also issued a rule concerning the proper disposal 
            of credit report information and records. 69 FR 68690 (Nov. 
            24, 2004). The Disposal Rule was effective on June 1, 2005.

[[Page 64302]]

5. On April 27, 2005, the Commission, in consultation with the Federal 
            banking agencies and NCUA, issued notice of its publication 
            of guidance Take Charge: Fighting Back Against Identity 
            Theft, which is available at www.consumer.gov/idtheft or by 
            writing to FTC, Consumer Response Center, Room 130-B, 600 
            Pennsylvania Avenue, NW, Washington, DC 20580. This 
            document contains model forms and describes procedures that 
            identity theft victims may use for contacting and informing 
            creditors and consumer reporting agencies of the fraud.
 Third, for the rulemaking implementing the Controlling the Assault of 
Non-Solicited Pornography and Marketing Act (the CAN-SPAM Act), the 
Commission announced the final rule defining the relevant criteria to 
facilitate the determination of the primary purpose of an electronic 
message on December 16, 2004, which was published in the Federal 
Register on Jan. 19, 2005, 70 FR 3110. The rule became effective on 
March 28, 2005.
 Fourth, for the HSR Rules, the Commission issued a Final Rule to 
reconcile, as far as practical, the current disparate treatment of 
corporations, partnerships, limited liability companies, and other 
types of non-corporate entities under the rules. See 70 FR 11502 (Mar. 
8, 2005). Among other things, the amendments addressed acquisitions of 
interests in unincorporated entities; formations of unincorporated 
entities; and the application of certain exemptions, including the 
intraperson exemption.
Fifth, the Commission issued amendments to the R-Value Rule for home 
insulation, 16 CFR part 460, requiring disclosures that will make it 
easier to ensure that the correct amount of loose-fill insulation is 
installed in homes; update the required tests for some insulation 
products; delete disclosures for insulation products no longer sold; 
and eliminate duplicative disclosure requirements for sellers of do-it-
yourself home insulation. 70 FR 31258 (May 31, 2005). The amendments 
will become effective on Nov. 28, 2005.
Finally, with respect to the TSR Rules, the Commission also published 
an NPRM concerning a revised fee structure for the National Do-Not-Call 
Registry on April 22, 2005. 70 FR 20848. The comment period ended on 
June 1, 2005. The Commission published final fee changes for the 
National Do-Not-Call Registry on July 27, 2005, with an effective date 
of September 1, 2005. 70 FR 43273.
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 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 final rules issued by the Commission continue to be 
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 57 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.
Rulemakings that Respond to Public Regulatory Reform Nominations
During March 2002, OMB requested public nominations for regulatory 
reforms. The Office of Information and Regulatory Affairs (OIRA) 
conducted a preliminary review of the public comments received and 
found five FTC activities that one or more commenters had nominated for 
reform. In a March 7, 2003 letter, the FTC responded that the agency 
systematically reviews all regulations and guides on a ten-year basis 
and explained how the agency had already reviewed or was about to 
review the activity at issue or why some of the other activities were 
not good candidates for reform as contemplated by the Smarter 
Regulations Report. In 2004, OIRA requested recommendations for reform 
in the manufacturing sector. OIRA received two nominations for FTC 
action but determined not to include them in the Report to Congress on 
agency responses to reform nominations in the manufacturing sector.\1\
---------------------------------------------------------------------------
\1\ The two nominations were: 1) a comment concerning the DOE and FTC 
requirements for reporting water usage (the FTC's response indicated 
that the agencies have accepted the requested data based on third party 
reports since 1993); and 2) a comment that the DOE, FTC and EPA should 
work with industry to streamline duplicative energy labels (the FTC's 
response noted that since 2000, where appropriate, manufacturers have 
been allowed to place the Energy Star logo on EnergyGuide Labels and 
noted that the two labels provide different information to the 
consumer).
---------------------------------------------------------------------------
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 64303]]




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 and 
game classifications for gaming machines and related gaming systems is 
an important initiative for the promotion and protection of tribal 
gaming.
 Additionally, the Commission will be continuing to make 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.
_______________________________________________________________________



NIGC

                              -----------

                          PROPOSED RULE STAGE

                              -----------




161. TECHNICAL AMENDMENTS TO THE MINIMUM INTERNAL CONTROL STANDARDS

Priority:


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


Legal Authority:


25 USC 2702; 25 USC 2706(b)(10)


CFR Citation:


25 CFR 542


Legal Deadline:


None


Abstract:


The National Indian Gaming Commission is making technical changes to 
the Minimum Internal Control Standards (MICS) in response to changes in 
technology and the gaming industry. The Commission will routinely 
revise the MICS in response to these changes.


Statement of Need:


Periodic technical adjustments and revisions to the Minimum Internal 
Control Standards (MICS) are necessary in order to keep the MICS 
effective in protecting Tribal gaming assets and the interests of 
Tribal stakeholders and the gaming public.


Summary of Legal Basis:


It is the goal of 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)). The Indian 
Gaming Regulatory Act 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 MICS to ensure uniformity and integrity in tribal 
gaming.


Alternatives:


If the Commission does not periodically update the MICS, the 
regulations that govern Tribal gaming will not address changing 
technology and gaming methods.


Anticipated Cost and Benefits:


Updated MICS will aid Tribal governments in the regulation of their 
gaming activities.


Risks:


There are no known risks to this regulatory action.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
First NPRM                      12/01/04                    69 FR 69847
Second NPRM                     03/10/05                    70 FR 11893
Final Action on First 
    Rule                        05/04/05                    70 FR 23011
Final Action on Second 
    Rule                        08/12/05                    70 FR 47097
Third NPRM                      11/00/05
Fourth NPRM                        To Be                     Determined

Regulatory Flexibility Analysis Required:


No


Government Levels Affected:


Tribal


Agency Contact:
Penny J. Coleman
Acting General Counsel
National Indian Gaming Commission
Suite 9100
Suite 9100
1441 L Street NW.
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
RIN: 3141-AA27

[[Page 64304]]

_______________________________________________________________________



NIGC



162. TECHNICAL STANDARDS FOR 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 547


Legal Deadline:


None


Abstract:


It is necessary for the National Indian Gaming Commission (NIGC) to 
promulgate regulations establishing technical standards in order to 
assure the integrity of electronic equipment used with the play of 
class II games. Technical standards will address actual operation of 
gaming machines and systems and the equipment related to their 
operation.


Statement of Need:


Technical standards are needed to assure machine games are operated in 
a manner that ensures uniformity and integrity in tribal gaming.


Summary of Legal Basis:


It is the goal of 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)). The Indian 
Gaming Regulatory Act 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 gaming machines to ensure 
uniformity and integrity in tribal gaming.


Alternatives:


If the Commission does not issue a rule establishing technical 
standards for gaming machines, tribal gaming will not have the benefit 
of a standard that can help promote the integrity of the equipment in 
class II gaming.


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:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            05/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Tribal


Federalism:


 Undetermined


Agency Contact:
Michael Gross
Staff Attorney
National Indian Gaming Commission
1441 L St NW, Suite 9100
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
RIN: 3141-AA29
_______________________________________________________________________



NIGC



163. GAME CLASSIFICATION STANDARDS

Priority:


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


Unfunded Mandates:


Undetermined


Legal Authority:


25 USC 2706


CFR Citation:


25 CFR 546


Legal Deadline:


None


Abstract:


It is necessary for the National Indian Gaming Commission (NIGC) to 
promulgate regulations establishing game classification standards 
because of the distinction between class II and class III gaming set 
forth in the Indian Gaming Regulatory Act (IGRA). Technical changes 
make it difficult for regulators to keep up with the gaming industry. 
By establishing classification standards, tribal gaming commissions, 
the primary regulators of tribal gaming, will more easily be able to 
distinguish between class II and class III machines.


Statement of Need:


Gaming Classification standards are needed to assure that regulators 
can determine whether gaming machines are class II or class III devices 
under IGRA.


Summary of Legal Basis:


It is the goal of 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 game 
classifications and gaming machines, or (2) continue evaluating 
classifications on a case-by-case basis.


Anticipated Cost and Benefits:


The development of classification standards will reduce the cost of 
regulation to the Federal Government. Additionally, classification 
standards will aid tribal governments in the regulations of their 
gaming activities. The only anticipated cost will be to gaming machine 
manufacturers.

[[Page 64305]]

Risks:


There are no known risks to this regulatory action.


Timetable:
_______________________________________________________________________
Action                            Date                        FR Cite

_______________________________________________________________________
NPRM                            05/00/06

Regulatory Flexibility Analysis Required:


No


Small Entities Affected:


No


Government Levels Affected:


Tribal


Federalism:


 Undetermined


Agency Contact:
Michael Gross
Staff Attorney
National Indian Gaming Commission
1441 L St NW, Suite 9100
Washington, DC 20005
Phone: 202 632-7003
Fax: 202 632-7066
RIN: 3141-AA31
BILLING CODE 7565-01-S
