Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79459 

DEPARTMENT OF AGRICULTURE 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

1 Wholesale Pork Reporting Program 0581–AD07 Proposed Rule 

Stage 

2 National Dairy Promotion and Research Program; Dairy Import Assessments, DA-08- 

0050 0581–AC87 Final Rule Stage 

3 Animal Welfare; Regulations and Standards for Birds 0579–AC02 Proposed Rule 

Stage 

4 Plant Pest Regulations; Update of General Provisions 0579–AC98 Proposed Rule 

Stage 

5 Importation of Live Dogs 0579–AD23 Proposed Rule 

Stage 

6 Animal Disease Traceability 0579–AD24 Proposed Rule 

Stage 

7 Importation of Plants for Planting; Establishing a New Category of Plants for Planting Not 

Authorized for Importation Pending Pest Risk Analysis 0579–AC03 Final Rule Stage 

8 Multi-Family Housing (MFH) Reinvention 0575–AC13 Final Rule Stage 

9 Enforcement of the Packers and Stockyards Act 0580–AB07 Final Rule Stage 

10 Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation, and Energy Act of 2008 0584–AD87 Proposed Rule 

Stage 

11 Supplemental Nutrition Assistance Program: Farm Bill of 2008 Retailer Sanctions 0584–AD88 Proposed Rule 

Stage 

12 Fresh Fruit and Vegetable Program 0584–AD96 Proposed Rule 

Stage 

13 Child and Adult Care Food Program: Improving Management and Program Integrity 0584–AC24 Final Rule Stage 

14 Direct Certification of Children in Food Stamp Households and Certification of Homeless, 

Migrant, and Runaway Children for Free Meals in the NSLP, SBP, and SMP 0584–AD60 Final Rule Stage 

15 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages 0584–AD77 Final Rule Stage 

16 Egg Products Inspection Regulations 0583–AC58 Proposed Rule 

Stage 

17 New Poultry Slaughter Inspection 0583–AD32 Proposed Rule 

Stage 

18 Mandatory Inspection of Catfish and Catfish Products 0583–AD36 Proposed Rule 

Stage 

19 Electronic Imported Product Inspection Applications; Electronic Foreign Imported Product 

and Foreign Establishment Certifications; Deletion of Streamlined Inspection Procedures 

for Canadian Product 0583–AD39 Proposed Rule 

Stage 

20 Electronic Export Application and Certification as a Reimbursable Service and Flexibility 

in the Requirements for Official Export Inspection Marks, Devices, and Certificates 0583–AD41 Proposed Rule 

Stage 

21 Performance Standards for the Production of Processed Meat and Poultry Products; 

Control of Listeria Monocytogenes in Ready-To-Eat Meat and Poultry Products 0583–AC46 Final Rule Stage 

22 Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products 0583–AC60 Final Rule Stage 

23 Notification, Documentation, and Recordkeeping Requirements for Inspected Establishments 0583–AD34 Final Rule Stage 

24 Federal-State Interstate Shipment Cooperative Inspection Program 0583–AD37 Final Rule Stage 

25 Value-Added Producer Grant Program 0570–AA79 Final Rule Stage 

26 Rural Broadband Access Loans and Loan Guarantees 0572–AC06 Final Rule Stage 

DEPARTMENT OF COMMERCE 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

27 Designation of Critical Habitat for the North Atlantic Right Whale 0648–AY54 Proposed Rule 

Stage 

28 Certification of Nations Whose Fishing Vessels Are Engaged in Illegal, Unreported, and 

Unregulated Fishing or Bycatch of Protected Living Marine Resources 0648–AV51 Final Rule Stage 


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DEPARTMENT OF COMMERCE (Continued) 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

29 Critical Habitat Designation for Cook Inlet Beluga Whale Under the Endangered Species 

Act 0648–AX50 Final Rule Stage 

30 Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Amendments 20 and 

21; Trawl Rationalization Program 0648–AY68 Final Rule Stage 

DEPARTMENT OF DEFENSE 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

31 Voluntary Education Programs 0790–AI50 Final Rule Stage 

32 TRICARE; Reimbursement of Sole Community Hospitals 0720–AB41 Proposed Rule 

Stage 

DEPARTMENT OF EDUCATION 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

33 Title IV of the Higher Education Act of 1965, as Amended 1840–AD05 Proposed Rule 

Stage 

34 Program Integrity: Gainful Employment—Measures 1840–AD06 Final Rule Stage 

DEPARTMENT OF ENERGY 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

35 Energy Efficiency Standards for Clothes Dryers and Room Air Conditioners 1904–AA89 Proposed Rule 

Stage 

36 Energy Efficiency Standards for Residential Central Air Conditioners and Heat Pumps 1904–AB47 Proposed Rule 

Stage 

37 Energy Efficiency Standards for Fluorescent Lamp Ballasts 1904–AB50 Proposed Rule 

Stage 

38 Energy Efficiency Standards for Residential Furnaces 1904–AC06 Proposed Rule 

Stage 

39 Energy Efficiency Standards for Manufactured Housing 1904–AC11 Proposed Rule 

Stage 

40 Energy Efficiency Standards for Residential Refrigerators, Refrigerator-Freezers, and 

Freezers 1904–AB79 Final Rule Stage 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

41 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health 

Information Technology for Economic and Clinical Health Act 0991–AB57 Final Rule Stage 

42 Transparency Reporting 0950–AA07 Proposed Rule 

Stage 

43 Rate Review 0950–AA03 Final Rule Stage 

44 Uniform Explanation of Benefits, Coverage Facts, and Standardized Definitions 0950–AA08 Final Rule Stage 

45 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 0910–AC52 Proposed Rule 

Stage 

46 Unique Device Identification 0910–AG31 Proposed Rule 

Stage 

47 Cigarette Warning Label Statements 0910–AG41 Proposed Rule 

Stage 


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DEPARTMENT OF HEALTH AND HUMAN SERVICES (Continued) 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

48 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines 0910–AG56 Proposed Rule 

Stage 

49 Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants 0910–AG57 Proposed Rule 

Stage 

50 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors 0910–AF27 Final Rule Stage 

51 Medical Device Reporting; Electronic Submission Requirements 0910–AF86 Final Rule Stage 

52 Electronic Registration and Listing for Devices 0910–AF88 Final Rule Stage 

53 Requirements for Long-Term Care Facilities: Notification of Facility Closure (CMS-3230- 

IFC) 0938–AQ09 Proposed Rule 

Stage 

54 Medicare Shared Savings Program: Accountable Care Organizations (CMS-1345-P) 0938–AQ22 Proposed Rule 

Stage 

55 Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute 

Care Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and RY 

2012 Rates (CMS-1518-P) 0938–AQ24 Proposed Rule 

Stage 

56 Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 

2012 (CMS-1524-P) 0938–AQ25 Proposed Rule 

Stage 

57 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System for CY 2012 (CMS-1525-P) 0938–AQ26 Proposed Rule 

Stage 

58 Civil Money Penalties for Nursing Homes (CMS-2435-F) 0938–AQ02 Final Rule Stage 

59 Designation Renewal of Head Start Grantees 0970–AC44 Proposed Rule 

Stage 

60 Community Living Assistance Services and Supports Enrollment and Eligibility Rules 

Under the Affordable Care Act 0985–AA07 Proposed Rule 

Stage 

DEPARTMENT OF HOMELAND SECURITY 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

61 Secure Handling of Ammonium Nitrate Program 1601–AA52 Proposed Rule 

Stage 

62 Collection of Alien Biometric Data Upon Exit From the United States at Air and Sea 

Ports of Departure; United States Visitor and Immigrant Status Indicator Technology 

Program (US-VISIT) 1601–AA34 Final Rule Stage 

63 Asylum and Withholding Definitions 1615–AA41 Proposed Rule 

Stage 

64 Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of 

Aliens Subject to Numerical Limitations 1615–AB71 Proposed Rule 

Stage 

65 Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, 

and Withholding of Removal 1615–AB89 Proposed Rule 

Stage 

66 New Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T 

Nonimmigrant Status 1615–AA59 Final Rule Stage 

67 Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant 

Status 1615–AA60 Final Rule Stage 

68 New Classification for Victims of Criminal Activity; Eligibility for the ‘‘U’’ Nonimmigrant 

Status 1615–AA67 Final Rule Stage 

69 E-2 Nonimmigrant Status for Aliens in the Commonwealth of the Northern Mariana Islands With Long-Term Investor Status 1615–AB75 Final Rule Stage 

70 Commonwealth of the Northern Mariana Islands Transitional Worker Classification 1615–AB76 Final Rule Stage 

71 Application of Immigration Regulations to the Commonwealth of the Northern Mariana Islands 1615–AB77 Final Rule Stage 

72 Outer Continental Shelf Activities 1625–AA18 Proposed Rule 

Stage 


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DEPARTMENT OF HOMELAND SECURITY (Continued) 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

73 Inspection of Towing Vessels 1625–AB06 Proposed Rule 

Stage 

74 Assessment Framework and Organizational Restatement Regarding Preemption for Certain Regulations Issued by the Coast Guard 1625–AB32 Proposed Rule 

Stage 

75 Updates to Maritime Security 1625–AB38 Proposed Rule 

Stage 

76 Standards for Living Organisms in Ships’ Ballast Water Discharged in U.S. Waters 1625–AA32 Final Rule Stage 

77 Importer Security Filing and Additional Carrier Requirements 1651–AA70 Final Rule Stage 

78 Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization (ESTA) Program 1651–AA72 Final Rule Stage 

79 Establishment of Global Entry Program 1651–AA73 Final Rule Stage 

80 Implementation of the Guam-CNMI Visa Waiver Program 1651–AA77 Final Rule Stage 

81 Large Aircraft Security Program, Other Aircraft Operator Security Program, and Airport 

Operator Security Program 1652–AA53 Proposed Rule 

Stage 

82 Public Transportation and Passenger Railroads—Security Training of Employees 1652–AA55 Proposed Rule 

Stage 

83 Freight Railroads—Security Training of Employees 1652–AA57 Proposed Rule 

Stage 

84 Over-the-Road Buses—Security Training of Employees 1652–AA59 Proposed Rule 

Stage 

85 Aircraft Repair Station Security 1652–AA38 Final Rule Stage 

86 Air Cargo Screening 1652–AA64 Final Rule Stage 

87 Continued Detention of Aliens Subject to Final Orders of Removal 1653–AA60 Proposed Rule 

Stage 

88 Continued Detention of Aliens Subject to Final Orders of Removal 1653–AA13 Final Rule Stage 

89 Extending Period for Optional Practical Training by 17 Months for F-1 Nonimmigrant Students With STEM Degrees and Expanding the CAP-GAP Relief for All F-1 Students 

With Pending H-1B Petitions 1653–AA56 Final Rule Stage 

90 Update of FEMA’s Public Assistance Regulations 1660–AA51 Proposed Rule 

Stage 

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

91 Title I Energy Retrofit Property Improvement Loans (FR-5445) 2502–AI93 Proposed Rule 

Stage 

92 Housing Counseling: New Program Requirements (FR-5446) 2502–AI94 Proposed Rule 

Stage 

DEPARTMENT OF JUSTICE 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

93 National Standards to Prevent, Detect, and Respond to Prison Rape 1105–AB34 Proposed Rule 

Stage 

DEPARTMENT OF LABOR 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

94 Construction Contractor Affirmative Action Requirements 1250–AA01 Proposed Rule 

Stage 


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DEPARTMENT OF LABOR (Continued) 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

95 Persuader Agreements: Employer and Labor Relations Consultant Reporting Under the 

LMRDA 1245–AA03 Proposed Rule 

Stage 

96 Right To Know Under the Fair Labor Standards Act 1235–AA04 Proposed Rule 

Stage 

97 Labor Certification Process and Enforcement for Temporary Employment in Occupations 

Other Than Agriculture or Registered Nursing in the United States (H-2B Workers) 1205–AB58 Proposed Rule 

Stage 

98 Equal Employment Opportunity in Apprenticeship and Training, Amendment of Regulations 1205–AB59 Proposed Rule 

Stage 

99 Lifetime Income Options for Participants and Beneficiaries in Retirement Plans 1210–AB33 Prerule Stage 

100 Definition of ‘‘Fiduciary’’ 1210–AB32 Proposed Rule 

Stage 

101 Respirable Crystalline Silica Standard 1219–AB36 Proposed Rule 

Stage 

102 Lowering Miners’ Exposure to Coal Mine Dust, Including Continuous Personal Dust Monitors 1219–AB64 Proposed Rule 

Stage 

103 Safety and Health Management Programs for Mines 1219–AB71 Proposed Rule 

Stage 

104 Pattern of Violations 1219–AB73 Proposed Rule 

Stage 

105 Maintenance of Incombustible Content of Rock Dust in Underground Coal Mines 1219–AB76 Proposed Rule 

Stage 

106 Proximity Detection Systems for Underground Mines 1219–AB65 Final Rule Stage 

107 Infectious Diseases 1218–AC46 Prerule Stage 

108 Injury and Illness Prevention Program 1218–AC48 Prerule Stage 

109 Backing Operations 1218–AC52 Prerule Stage 

110 Occupational Exposure to Crystalline Silica 1218–AB70 Proposed Rule 

Stage 

111 Occupational Injury and Illness Recording and Reporting Requirements—Modernizing 

OSHA’s Reporting System 1218–AC49 Proposed Rule 

Stage 

112 Hazard Communication 1218–AC20 Final Rule Stage 

DEPARTMENT OF TRANSPORTATION 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

113 Enhancing Airline Passenger Protections—Part 2 2105–AD92 Final Rule Stage 

114 Qualification, Service, and Use of Crewmembers and Aircraft Dispatchers 2120–AJ00 Proposed Rule 

Stage 

115 Air Ambulance and Commercial Helicopter Operations; Safety Initiatives and Miscellaneous Amendments 2120–AJ53 Proposed Rule 

Stage 

116 Flight and Duty Time Limitations and Rest Requirements 2120–AJ58 Final Rule Stage 

117 Carrier Safety Fitness Determination 2126–AB11 Proposed Rule 

Stage 

118 Electronic On-Board Recorders and Hours of Service Supporting Documents 2126–AB20 Proposed Rule 

Stage 

119 Hours of Service 2126–AB26 Proposed Rule 

Stage 

120 Drivers of Commercial Vehicles: Restricting the Use of Cellular Phones 2126–AB29 Proposed Rule 

Stage 

121 National Registry of Certified Medical Examiners 2126–AA97 Final Rule Stage 

122 Passenger Car and Light Truck Corporate Average Fuel Economy Standards MYs 2017 

and Beyond 2127–AK79 Prerule Stage 

123 Federal Motor Vehicle Safety Standard No. 111, Rearview Mirrors 2127–AK43 Proposed Rule 

Stage 


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DEPARTMENT OF TRANSPORTATION (Continued) 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

124 Commercial Medium- and Heavy-Duty On-Highway Vehicles and Work Truck Fuel Efficiency Standards 2127–AK74 Proposed Rule 

Stage 

125 Ejection Mitigation 2127–AK23 Final Rule Stage 

126 Hours of Service: Passenger Train Employees 2130–AC15 Proposed Rule 

Stage 

127 Major Capital Investment Projects 2132–AB02 Proposed Rule 

Stage 

128 Hazardous Materials: Limiting the Use of Mobile Telephones by Highway 2137–AE65 Proposed Rule 

Stage 

129 Hazardous Materials: Limiting the Use of Electronic Devices by Highway 2137–AE63 Final Rule Stage 

ENVIRONMENTAL PROTECTION AGENCY 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

130 Review of the National Ambient Air Quality Standards for Carbon Monoxide 2060–AI43 Proposed Rule 

Stage 

131 Review of the National Ambient Air Quality Standards for Particulate Matter 2060–AO47 Proposed Rule 

Stage 

132 Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen 

and Oxides of Sulfur 2060–AO72 Proposed Rule 

Stage 

133 National Emission Standards for Hazardous Air Pollutants for Coal- and Oil-Fired Electric 

Utility Steam Generating Units 2060–AP52 Proposed Rule 

Stage 

134 Control of Greenhouse Gas Emissions From Medium and Heavy-Duty Vehicles 2060–AP61 Proposed Rule 

Stage 

135 Review of the National Ambient Air Quality Standards for Lead 2060–AQ44 Proposed Rule 

Stage 

136 NPDES Electronic Reporting Rule 2020–AA47 Proposed Rule 

Stage 

137 Regulations To Facilitate Compliance With the Federal Insecticide, Fungicide, and 

Rodenticide Act by Producers of Plant-Incorporated Protectants (PIPs) 2070–AJ32 Proposed Rule 

Stage 

138 Mercury; Regulation of Use in Certain Products 2070–AJ46 Proposed Rule 

Stage 

139 Nanoscale Materials; Reporting Under TSCA Section 8(a) 2070–AJ54 Proposed Rule 

Stage 

140 Nanoscale Materials; Significant New Use Rule (SNUR) 2070–AJ67 Proposed Rule 

Stage 

141 Revisions to EPA’s Rule on Protections for Subjects in Human Research Involving Pesticides 2070–AJ76 Proposed Rule 

Stage 

142 Hazardous Waste Management Systems: Identification and Listing of Hazardous Waste: 

Carbon Dioxide (CO2) Injectate in Geological Sequestration Activities 2050–AG60 Proposed Rule 

Stage 

143 Financial Responsibility Requirements Under CERCLA Section 108(b) for Classes of Facilities in the Hard Rock Mining Industry 2050–AG61 Proposed Rule 

Stage 

144 NPDES Permit Requirements for Municipal Sanitary and Combined Sewer Collection 

Systems, Municipal Satellite Collection Systems, Sanitary Sewer Overflows, and Peak 

Excess Flow Treatment Facilities 2040–AD02 Proposed Rule 

Stage 

145 Criteria and Standards for Cooling Water Intake Structures 2040–AE95 Proposed Rule 

Stage 

146 Stormwater Regulations Revision To Address Discharges From Developed Sites 2040–AF13 Proposed Rule 

Stage 


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ENVIRONMENTAL PROTECTION AGENCY (Continued) 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

147 National Pollutant Discharge Elimination System (NPDES) Permit Regulations for New 

Dischargers and the Appropriate Use of Offsets With Regard to Water Quality Permitting 2040–AF17 Proposed Rule 

Stage 

148 Concentrated Animal Feeding Operations (CAFO) Information Collection Request Rule 2040–AF22 Proposed Rule 

Stage 

149 National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, 

Commercial, and Institutional Boilers 2060–AM44 Final Rule Stage 

150 Transport Rule (CAIR Replacement Rule) 2060–AP50 Final Rule Stage 

151 Revision to Pb Ambient Air Monitoring Requirements 2060–AP77 Final Rule Stage 

152 Reconsideration of the 2008 Ozone Primary and Secondary National Ambient Air Quality 

Standards 2060–AP98 Final Rule Stage 

153 Revisions to Motor Vehicle Fuel Economy Label 2060–AQ09 Final Rule Stage 

154 National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, 

Commercial, and Institutional Boilers and Process Heaters 2060–AQ25 Final Rule Stage 

155 Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, and 

Painting Program 2070–AJ57 Final Rule Stage 

156 Identification of Non-Hazardous Secondary Materials That Are Solid Wastes 2050–AG44 Final Rule Stage 

EQUAL EMPLOYMENT OPPORTUNITY COMMISSION 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

157 Regulations To Implement the Equal Employment Provisions of the Americans With Disabilities Act Amendments Act 3046–AA85 Final Rule Stage 

NATIONAL ARCHIVES AND RECORDS ADMINISTRATION 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

158 Office of Government Information Services 3095–AB62 Proposed Rule 

Stage 

159 Declassification of National Security Information 3095–AB64 Proposed Rule 

Stage 

SMALL BUSINESS ADMINISTRATION 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

160 Small Business Jobs Act: Multiple Award Contracts and Small Business Set-Asides 3245–AG20 Proposed Rule 

Stage 

161 Small Business Size Regulations; (8)a Business Development/Small Disadvantaged 

Business Status Determination 3245–AF53 Final Rule Stage 

162 Small Business Jobs Act: 504 Loan Program Debt Refinancing 3245–AG17 Final Rule Stage 

163 Small Business Jobs Act: Small Business Intermediary Lending Pilot Program 3245–AG18 Final Rule Stage 

SOCIAL SECURITY ADMINISTRATION 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

164 Revised Medical Criteria for Evaluating Respiratory System Disorders (859P) 0960–AF58 Proposed Rule 

Stage 

165 Revised Medical Criteria for Evaluating Hematological Disorders (974P) 0960–AF88 Proposed Rule 

Stage 


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SOCIAL SECURITY ADMINISTRATION (Continued) 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

166 Revised Medical Criteria for Evaluating Endocrine System Disorders (436P) 0960–AD78 Final Rule Stage 

167 Revised Medical Criteria for Evaluating Mental Disorders (886P) 0960–AF69 Final Rule Stage 

168 Reestablishing Uniform National Disability Adjudication Provisions (3502F) 0960–AG80 Final Rule Stage 

169 Amendments to Regulations Regarding Major Life-Changing Events Affecting IncomeRelated Monthly Adjustments Amounts to Medicare Part B Premiums (3574F) 0960–AH06 Final Rule Stage 

170 Amendments to Regulations Regarding Withdrawals of Applications and Voluntary Suspension of Benefits (3573I) 0960–AH07 Final Rule Stage 

CONSUMER PRODUCT SAFETY COMMISSION 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

171 Testing, Certification, and Labeling of Certain Consumer Products 3041–AC71 Final Rule Stage 

NATIONAL INDIAN GAMING COMMISSION 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

172 Tribal Background Investigation Submission Requirements and Timing 3141–AA15 Proposed Rule 

Stage 

173 Class II and Class III Minimum Internal Control Standards 3141–AA27 Proposed Rule 

Stage 

POSTAL REGULATORY COMMISSION 

Sequence 

Number Title 

Regulation 

Identifier 

Number 

Rulemaking Stage 

174 Periodic Reporting Exceptions 3211–AA06 Final Rule Stage 

[FR Doc. 2010–30473 Filed 12–17–10;8:45 am] 

BILLING CODE 6820–27–S 


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DEPARTMENT OF AGRICULTURE 

(USDA) 

Statement of Regulatory Priorities 

USDA’s regulatory efforts in the 

coming year will be focused on 

achieving the Department’s goals 

identified in the Department’s Strategic 

Plan for 2010 to 2015. To assist the 

country in addressing today’s 

challenges, USDA established the 

following goals: 

• Assist rural communities to create 

prosperity so they are self-sustaining, 

re-populating, and economically 

thriving. USDA is the leading 

advocate for rural America. The 

Department supports rural 

communities and enhances quality of 

life for rural residents by improving 

their economic opportunities, 

community infrastructure, 

environmental health, and the 

sustainability of agricultural 

production. The common goal is to 

help create thriving rural 

communities where people want to 

live and raise families, and where 

children have economic opportunities 

and a bright future. 

• Ensure that all of America’s children 

have access to safe, nutritious, and 

balanced meals. A plentiful supply of 

safe and nutritious food is essential to 

the well-being of every family and the 

healthy development of every child in 

America. USDA provides nutrition 

assistance to children and low-income 

people who need it and works to 

improve the healthy eating habits of 

all Americans, especially children. In 

addition, the Department safeguards 

the quality and wholesomeness of 

meat, poultry, and egg products and 

addresses and prevents loss and 

damage from pests and disease 

outbreaks. 

• Ensure our national forests and 

private working lands are conserved, 

restored, and made more resilient to 

climate change, while enhancing our 

water resources. America’s prosperity 

is inextricably linked to the health of 

our lands and natural resources. 

Forests, farms, ranches, and 

grasslands offer enormous 

environmental benefits as a source of 

clean air, clean and abundant water, 

and wildlife habitat. These lands 

generate economic value by 

supporting the vital agriculture and 

forestry sectors, attracting tourism and 

recreation visitors, sustaining green 

jobs, and producing ecosystem 

services, food, fiber, timber and nontimber products, and energy. They are 

also of immense social importance, 

enhancing rural quality of life, 

sustaining scenic and culturally 

important landscapes, and providing 

opportunities to engage in outdoor 

activity and reconnect with the land. 

• Help America promote agricultural 

production and biotechnology exports 

as America works to increase food 

security. A productive agricultural 

sector is critical to increasing global 

food security. For many crops, a 

substantial portion of domestic 

production is bound for overseas 

markets. USDA helps American 

farmers and ranchers use efficient, 

sustainable production, 

biotechnology, and other emergent 

technologies to enhance food security 

around the world and find export 

markets for their products. 

Important regulatory activities 

supporting the accomplishment of these 

goals in 2011 will include the following: 

• Rural Development and Renewable 

Energy. USDA priority regulatory 

actions for the Rural Development 

mission will be to finalize regulations 

for bioenergy programs, including the 

Biorefinery Assistance Program. 

While USDA utilized notices of 

funding availability to implement 

many of these programs in fiscal years 

2009 and 2010, regulations are 

required for permanent 

implementation. Access to affordable 

broadband to all rural Americans is 

another priority. USDA will finalize 

reform of its on-going broadband 

access program through an interim 

rule. Rural Development will utilize 

comments received from the proposed 

rule, address statutory changes 

required by the 2008 Farm Bill, and 

incorporate lessons learned from 

implementing the American Recovery 

and Reinvestment Act program to 

develop the interim rule. 

USDA will continue to promote 

sustainable economic opportunities to 

revitalize rural communities through 

the purchase and use of renewable, 

environmentally friendly biobased 

products through its BioPreferred 

Program. USDA will continue to 

designate groups of biobased products 

to receive procurement preference 

from Federal agencies and 

contractors. In addition, USDA will 

finalize a rule establishing the 

Voluntary Labeling Program for 

biobased products. 

• Nutrition Assistance. As changes are 

made to the nutrition assistance 

programs, USDA will work to foster 

actions that expand access to program 

benefits, improve program integrity, 

improve diets and healthy eating 

through nutrition education, and 

promote physical activity consistent 

with the national effort to reduce 

obesity. In support of these activities 

in 2011, the Food and Nutrition 

Service (FNS) will propose a rule 

updating nutrition standards in the 

school meals program, finalize a rule 

updating the WIC food packages, and 

establish permanent rules for the 

Fresh Fruit and Vegetable Program. 

FNS will continue to work to 

implement rules that minimize 

participant and vendor fraud in its 

nutrition assistance programs. 

• Food Safety. In the area of food safety, 

USDA will continue to develop 

science-based regulations that 

improve the safety of meat, poultry, 

and processed egg products in the 

least burdensome and most costeffective 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. FSIS 

will propose regulations to establish 

new systems for poultry slaughter 

inspection, catfish inspection, as well 

as a new voluntary Federal-State 

cooperative inspection program. To 

assist small entities to comply with 

food safety requirements, the Food 

Safety and Inspection Service will 

continue to collaborate with other 

USDA agencies and State partners in 

the enhanced small business outreach 

program. 

• Farm Loans and Disaster Assistance. 

USDA will work to ensure a strong 

U.S. agricultural system through farm 

income support and farm loan 

programs. In addition, USDA will 

implement a new disaster assistance 

program authorized by the 2008 Farm 

Bill, the Emergency Forest Restoration 

Program. Regulations are also being 

developed for conservation loan 

programs intended to help producers 

finance the construction of 

conservation measures. 

• Forestry and Conservation. USDA has 

completed all rulemaking for the new 

and reauthorized 2008 Farm Bill 

conservation programs and will focus 

on their continued implementation in 

2011. In the forestry area, the 

Department will focus on developing 

a new planning rule that improves the 

National forests’ planning process, 

decisionmaking, and the legal 

defensibility of land management 

plans. In 2011, the Department plans 

to complete the transition from the 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79468 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

2000 planning rule that is now in 

effect to the new planning rule that 

will update planning procedures to 

reflect contemporary collaborative 

planning practices. 

• Marketing and Regulatory Programs. 

USDA will work to support the 

organic sector and continue regulatory 

work to protect the health and value 

of U.S. agricultural and natural 

resources. USDA will also implement 

regulations to enhance enforcement of 

the Packers and Stockyards Act. In 

addition, USDA is working with 

stakeholders to develop acceptable 

animal disease traceability standards. 

Regarding plant health, USDA 

anticipates revising the permitting of 

plant pests and biological control 

organisms. USDA will also amend 

regulations for importing nursery 

stock to better address plant health 

risks associated with propagative 

material. For the Animal Welfare Act, 

USDA will propose specific standards 

for the humane care of birds and dogs 

imported for resale. USDA will also 

implement regulations to implement 

dairy promotion and research 

provisions of the 2008 Farm Bill. 

Reducing Paperwork Burden on 

Customers 

USDA continues to make 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 E-Government Act, 

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, 

USDA implemented an electronic 

authentication capability that allows 

customers to ‘‘sign-on’’ once and 

conduct business with all USDA 

agencies. Supporting 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. 

Major Regulatory Priorities 

This document represents summary 

information on prospective significant 

regulations as called for in Executive 

Order 12866. The following USDA 

agencies are represented in this 

regulatory plan, along with a summary 

of their mission and key regulatory 

priorities in 2011: 

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’ 2011 regulatory plan 

supports USDA’s goal to ensure that all 

of America’s children have access to 

safe, nutritious, and balanced meals: 

• Increase Access to Nutritious Food. 

This objective represents FNS’ efforts 

to improve nutrition by providing 

access to program benefits (food 

consumed at home, school meals, 

commodities) and distributing State 

administrative funds to support 

program operations. To advance this 

objective, FNS plans to publish a 

proposed rule to codify provisions of 

the 2008 Farm Bill that expand access 

to Supplemental Nutrition Assistance 

Program (SNAP) benefits and address 

other eligibility, certification, 

employment, and training issues. An 

interim rule implementing provisions 

of the Child Nutrition and WIC 

Reauthorization Act of 2004 to 

establish automatic eligibility for 

homeless children for school meals 

further supports this objective. 

• Promote Healthy Diet and Physical 

Activity Behaviors.This objective 

represents FNS’ efforts to improve the 

diets of its clients through nutrition 

education, support the national effort 

to reduce obesity by promoting 

healthy eating and physical activity, 

and to ensure that program benefits 

meet appropriate standards to 

effectively improve nutrition for 

program participants. In support of 

this objective, FNS plans to propose a 

rule updating the nutrition standards 

in the school meals programs, finalize 

a rule updating the WIC food 

packages, and establish permanent 

rules for the Fresh Fruit and Vegetable 

Program, which currently operates in 

a select number of schools in each 

State, the District of Columbia, Guam, 

Puerto Rico, and the Virgin Islands. 

Food Safety and Inspection Service 

Mission: The Food Safety and 

Inspection Service (FSIS) is responsible 

for ensuring that meat, poultry, egg, and 

catfish products in interstate and foreign 

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, egg, and catfish products 

are wholesome and not adulterated or 

misbranded. FSIS regulatory actions 

support the objective to protect public 

health by ensuring that food is safe 

under USDA’s goal to ensure access to 

safe food. To reduce the number of 

foodborne illnesses and increase 

program efficiencies, FSIS will continue 

to review its existing authorities and 

regulations to ensure that it can address 

emerging food safety challenges, to 

streamline excessively prescriptive 

regulations, and to revise or remove 

regulations that are inconsistent with 

the FSIS’ hazard analysis and critical 

control point (HACCP) regulations. FSIS 

is also working with the Food and Drug 

Administration (FDA) to improve 

coordination and increase the 

effectiveness of inspection activities. 

FSIS’ priority initiatives are as follows: 

• Rulemakings that support initiatives 

of the President’s Food Safety 

Working Group: 

– Poultry Slaughter Inspection. FSIS 

plans to amend poultry products 

inspection regulations to put in 

place a system in which the 

establishment sorts the carcasses for 

defects and FSIS verifies that the 

system is under control and 

producing safe and wholesome 

product. FSIS will propose to adopt 

performance standards designed to 

ensure that the establishments are 

carrying out slaughter, dressing, 

and chilling operations in a manner 

that ensures no significant growth 

of pathogens. 

– Revision of Egg Products Inspection 

Regulations. FSIS is planning to 

propose requirements for federally 

inspected egg product plants to 

develop and implement HACCP 

systems and sanitation standard 

operating procedures. FSIS will be 

proposing pathogen reduction 

performance standards for egg 

products and will remove 

prescriptive requirements for egg 

product plants. 

• Initiatives that provide for disclosure 

or that enable economic growth. FSIS 

plans to issue two final rules to 

promote disclosure of information to 

the public or that provide flexibility 

for the adoption of new technologies 

and that promote economic growth: 

– Nutrition Labeling of SingleIngredient Products and Ground or 


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Chopped Meat and Poultry 

Products. Regulations have been 

proposed to require nutrition 

information on the major cuts of 

single-ingredient, raw meat and 

poultry products to appear on the 

product label or at the point of 

purchase, unless an exemption 

applies. These regulations would 

also require nutrition labeling on all 

ground or chopped meat or poultry 

products unless an exemption 

applies. 

– Permission to Use Air Inflation of 

Meat Carcasses and Parts. FSIS has 

proposed to revise the Federal meat 

inspection regulations to permit 

establishments that slaughter 

livestock or prepare livestock 

carcasses and parts to inflate 

carcasses and parts with air if they 

develop, implement, and maintain 

written controls to ensure that the 

procedure does not cause insanitary 

conditions or adulterate product. In 

addition, FSIS has proposed to 

amend its regulations to remove the 

approved methods for inflating 

livestock carcasses and parts by air 

and the requirement that 

establishments seek approval from 

FSIS for inflation procedures not 

listed in the regulations. 

• Interstate Shipment of State-Inspected 

Meat and Poultry Products. As 

authorized by the 2008 Farm Bill, 

FSIS will issue final regulations to 

implement a new voluntary FederalState cooperative inspection program 

under which State-inspected 

establishments with 25 or fewer 

employees would be eligible to ship 

meat and poultry products in 

interstate commerce. 

• Notification, Documentation, and 

Recordkeeping Requirements for 

Inspected Establishments. As 

authorized by the 2008 Farm Bill, 

FSIS will issue final regulations that 

will require establishments that are 

subject to inspection to promptly 

notify FSIS when an adulterated or 

misbranded product received by or 

originating from the establishment has 

entered into commerce. The 

regulations also will require the 

establishments to prepare and 

maintain current procedures for the 

recall of all products produced and 

shipped by the establishments and to 

document each reassessment of the 

establishments’ process control plans. 

• Catfish Inspection. FSIS is developing 

regulations to implement provisions 

of the 2008 Farm Bill provisions that 

make catfish an amenable species 

under the Federal Meat Inspection 

Act (FMIA). 

• Public Health Information System. To 

support its food safety inspection 

activities, FSIS is developing the 

Public Health Information System 

(PHIS). PHIS, which is user-friendly 

and Web-based, will replace many of 

FSIS’ current systems and automate 

many business processes. To facilitate 

the implementation of some PHIS 

components, FSIS is proposing to 

provide for electronic export and 

import application and certification 

processes as alternatives to the 

current paper-based systems for these 

certifications. 

• Other planned initiatives. FSIS plans 

to finalize a February 2001 proposed 

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. 

Some provisions of the proposal 

addressed post-lethality 

contamination of RTE products with 

Listeria monocytogenes. In June 2003, 

FSIS published an interim final rule 

requiring establishments to prevent L. 

monocytogenes contamination of RTE 

products. FSIS has carefully reviewed 

its economic analysis of the interim 

final rule and is planning to affirm the 

interim rule as a final rule with 

changes. 

• FSIS small business implications. The 

great majority of businesses regulated 

by FSIS are small businesses. Some of 

the regulations listed above 

substantially affect small businesses. 

Some rulemakings can benefit small 

businesses. For example, the rule on 

interstate shipment of State-inspected 

products will open interstate markets 

to some small State-inspected 

establishments that previously could 

only sell their products within State 

boundaries. 

FSIS conducts a small business 

outreach program that provides critical 

training, access to food safety experts, 

and information resources (such as 

compliance guidance and questions and 

answers on various topics) in forms that 

are uniform, easily comprehended, and 

consistent. FSIS collaborates in this 

effort with other USDA agencies and 

cooperating State partners. For example, 

FSIS makes plant owners and operators 

aware of loan programs, available 

through USDA’s Rural Business and 

Cooperative programs, to help them in 

upgrading their facilities. FSIS 

employees meet with small and very 

small plant operators to learn more 

about their specific needs and provide 

joint training sessions for small and very 

small plants and FSIS employees. 

Animal and Plant Health Inspection 

Service 

Mission: A major part of the mission 

of the Animal and Plant Health 

Inspection Service (APHIS) is to protect 

the health and value of American 

agricultural and natural resources. 

APHIS regulatory actions support 

USDA’s goal of ensuring access to safe, 

plentiful, and nutritious food by 

minimizing major diseases and pests 

that have the potential for reducing 

agricultural productivity. In support of 

this goal, 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. APHIS also conducts 

programs to ensure the humane 

handling, care, treatment, and 

transportation of animals under the 

Animal Welfare Act. 

Priorities: With respect to animal 

health, APHIS is working with State and 

tribal representatives to identify a 

regulatory approach that will provide 

national traceability standards for 

livestock moved interstate while 

allowing each State and tribe the 

flexibility to work with their producers 

to develop standards that will work best 

for them. In the area of animal welfare, 

APHIS plans to propose standards for 

the humane handling, care, treatment, 

and transportation of birds covered 

under the Animal Welfare Act and to 

establish regulations to ensure the 

humane treatment of dogs imported into 

the United States for resale. Regarding 

plant health, APHIS anticipates 

publishing a proposed rule that would 

revise the current regulations governing 

the permitting of plant pests and 

biological control organisms. APHIS is 

also preparing a final rule that will 

conclude the first phase of its 

comprehensive revision to its 

regulations for importing nursery stock 

(plants for planting) to better address 

plant health risks associated with 

propagative material. 

Agricultural Marketing Service 

Mission: The Agricultural Marketing 

Service (AMS) provides marketing 

services to producers, manufacturers, 

distributors, importers, exporters, and 

consumers of food products. The AMS 


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also manages the government’s food 

purchases, supervises food quality 

grading, maintains food quality 

standards, and supervises the Federal 

research and promotion programs. AMS 

programs contribute to the achievement 

of a number of objectives under the 

Department’s goal to assist rural 

communities to create prosperity and 

the goal to ensure that all of America’s 

children have access to safe, nutritious, 

and balanced meals. 

Priorities: 

• National Organic Program (NOP). 

AMS’ priority items for the next year 

include several rulemakings that 

impact the organic industry. Statistics 

indicating rapid growth in the organic 

sector have highlighted issues that 

need to be addressed, including: 

– Origin of Livestock. On October 24, 

2008, NOP published a proposed 

rule with request for comments on 

the access to pasture requirements 

for ruminants. This proposed rule 

included a change in the origin of 

livestock requirements for dairy 

animals under section 205.236 of 

the NOP regulations. Many of the 

comments received on the October 

2008 proposed rule suggested that 

the origin of livestock issue should 

be pursued through a separate 

rulemaking from access to pasture. 

As a result, the proposed change to 

the origin of livestock requirements 

was not retained in the final rule on 

access to pasture published on 

February 17, 2010. AMS plans to 

develop a proposed rule specific to 

origin of livestock under the NOP 

during fiscal year (FY) 2011. 

– Periodic Pesticide Residue Testing. 

The Organic Foods Production Act 

(OFPA) of 1990 included language 

requiring certifying agents to 

conduct periodic residue testing of 

organic products produced or 

handled in accordance with the 

NOP. This requirement was meant 

to identify organic products that 

contained pesticides or other 

nonorganic residues in violation 

with the NOP or other applicable 

laws. In March 2010, an Office of 

Inspector General (OIG) audit of the 

NOP suggested that a legal review 

by the Office of General Counsel 

(OGC) of the current NOP 

regulations was needed to assess 

whether the existing regulations are 

in compliance with the residue 

testing requirement under OFPA. 

As a result of the legal opinion 

received by the NOP on this issue, 

AMS will publish a proposed rule 

on new periodic pesticide residue 

testing requirements in 2011. 

– Streamlining Enforcement Related 

Actions. The March 2010 Office of 

Inspector General (OIG) audit of the 

NOP raised issues related to the 

program’s process for imposing 

enforcement actions. One concern 

was that organic producers and 

handlers facing revocation or 

suspension of their certification are 

able to market their products as 

organic during what can be a 

lengthy appeals process. As a result, 

AMS will publish a proposed rule 

in 2011 to streamline the NOP 

appeals process such that appeals 

are reviewed and responded to in a 

timely manner. 

• Dairy Promotion and Research 

Program (Dairy Import Assessments). 

AMS has entered the final stage of 

establishing the National Dairy 

Promotion and Research Program. The 

Dairy Production Stabilization Act of 

1983 (Dairy Act) authorized USDA to 

create a national producer program for 

dairy product promotion, research, 

and nutrition education as part of a 

comprehensive strategy to increase 

human consumption of milk and 

dairy products. Dairy farmers fund 

this self-help program through a 

mandatory assessment on all milk 

produced in the contiguous 48 States 

and marketed commercially. Dairy 

farmers administer the national 

program through the National Dairy 

Promotion and Research Board (Dairy 

Board). 

The 2008 Farm Bill extended the 

program to include producers in Alaska, 

Hawaii, and Puerto Rico, who will pay 

an assessment of $0.15 per 

hundredweight of milk production. 

Imported dairy products will be 

assessed at $0.075 per hundredweight of 

fluid milk equivalent. AMS published 

proposed regulations establishing the 

program in the May 19, 2009, Federal 

Register. The proposal had a 30-day 

comment period. The final rule is 

expected to be published by the end of 

2010. 

Grain, Inspection, Packers and 

Stockyards Administration 

Mission: The Grain Inspection, 

Packers and Stockyards Administration 

(GIPSA) facilitates the marketing of 

livestock, poultry, meat, cereals, 

oilseeds, and related agricultural 

products and promotes fair and 

competitive trading practices for the 

overall benefit of consumers and 

American agriculture.GIPSA’s activities 

contribute significantly to the 

Department’s goal to increase prosperity 

in rural areas by supporting a 

competitive agricultural system. 

Priorities: GIPSA intends to issue a 

final rule that will define practices or 

conduct that are unfair, unjustly 

discriminatory, or deceptive, and/or that 

represent the making or giving of an 

undue or unreasonable preference or 

advantage, and ensure that producers 

and growers can fully participate in any 

arbitration process that may arise 

relating to livestock or poultry contracts. 

This regulation is being finalized in 

accordance with the authority granted to 

the Secretary by the Packers and 

Stockyards Act of 1921 and with the 

requirements of sections 11005 and 

11006 of the 2008 Farm Bill. 

Farm Service Agency 

Mission: The Farm Service Agency’s 

(FSA) mission is to equitably serve all 

farmers, ranchers, and agricultural 

partners through the delivery of 

effective, efficient agricultural programs, 

which contributes to two USDA goals. 

The goal of assisting rural communities 

in creating prosperity so they are selfsustaining, re-populating, and 

economically thriving; and the goal to 

enhance the Nation’s natural resource 

base by assisting owners and operators 

of farms and ranches to conserve and 

enhance soil, water, and related natural 

resources. It supports the first goal by 

stabilizing farm income, providing 

credit to new or existing farmers and 

ranchers who are temporarily unable to 

obtain credit from commercial sources, 

and helping farm operations recover 

from the effects of disaster. FSA 

supports the second goal by 

administering several conservation 

programs directed toward agricultural 

producers. The largest program is the 

Conservation Reserve Program (CRP), 

which protects nearly 32 million acres 

of environmentally sensitive land. 

Priorities: 

• Disaster Assistance. Regulations will 

be issued to establish a new disaster 

assistance program, the Emergency 

Forest Restoration Program. This 

program requires new regulations and 

minor revisions to the existing related 

Emergency Conservation Program 

regulations. 

• Biomass Crop Assistance Program. 

Final regulations were published to 

complete implementation of the 

Biomass Crop Assistance Program. 

This program supports the 

Administration’s energy initiative to 

accelerate the investment in and 

production of biofuels. The program 

will provide financial assistance to 


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agricultural and forest land owners 

and operators to establish and 

produce eligible crops, including 

woody biomass, for conversion to 

bioenergy, and the collection, harvest, 

storage, and transportation of eligible 

material for use in a biomass 

conversion facility. 

• Farm Loan Programs. FSA will 

develop and issue regulations to 

amend programs for farm operating 

loans, down payment loans, and 

emergency loans to include socially 

disadvantaged farmers, increase loan 

limits, loan size, funding targets, 

interest rates, and graduating 

borrowers to commercial credit. In 

addition, the regulations will 

establish a new direct and guaranteed 

loan program to assist farmers in 

implementing conservation practices. 

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 international 

forest and range conservation. Forest 

Service regulatory priorities support the 

accomplishment of the Department’s 

goal to ensure our National forests are 

conserved, restored, and made more 

resilient to climate change, while 

enhancing our water resources. 

Priorities: 

• Land Management Planning Rule. The 

Forest Service is required to issue 

rulemaking for National Forest 

System land management planning 

under 16 U.S.C. 1604. The first 

planning rule was adopted in 1979 

and amended in 1982. The Forest 

Service published a new planning 

rule on April 21, 2008 (73 FR 21468). 

On June 30, 2009, the United States 

District Court for the Northern District 

of California invalidated the Forest 

Service’s 2008 Planning Rule 

published at 36 CFR 219 based on 

violations of NEPA and ESA in the 

rulemaking process. The District 

Court vacated the 2008 rule, enjoined 

the USDA from further implementing 

it, and remanded it to the USDA for 

further proceedings. USDA has 

determined that the 2000 planning 

rule is now in effect, including its 

transition provisions as amended in 

2002 and 2003, and as clarified by 

interpretative rules issued in 2001 

and 2004, which allows the use of the 

provisions of the 1982 planning rule 

to amend or revise plans. The Forest 

Service is now in the 2000 planning 

rule transition period. The Forest 

Service is proposing a new planning 

rule. In so doing, the Forest Service 

plans to correct deficiencies that have 

been identified over two decades of 

forest planning and update planning 

procedures to reflect contemporary 

collaborative planning practices. 

• Community Forest and Open Space 

Conservation Program. The purpose of 

the Community Forest Program is to 

achieve community benefits through 

financial assistance grants to local 

governments, tribal governments, and 

nonprofit organizations to establish 

community forests by acquiring and 

protecting private forestlands. 

Community forest benefits are 

specified in the authorizing statute 

and include economic benefits from 

sustainable forest management, 

natural resource conservation, forestbased educational programs, model 

forest stewardship activities, and 

recreational opportunities. 

• Closure of NFS Lands to Protect 

Privacy of Tribal Activities. There is 

currently no provision for a special 

closure of NFS lands to protect the 

privacy of tribal activities for 

traditional and cultural purposes. The 

Forest Service will amend its 

regulations to allow special closure of 

NFS land to protect the privacy of 

tribal activities for traditional and 

cultural purposes. 

Rural Business-Cooperative Service 

Mission: Promoting a dynamic 

business environment in rural America 

is the goal of the Rural BusinessCooperative Service (RBS). Business 

Programs works in partnership with the 

private sector and the community-based 

organizations to provide financial 

assistance and business planning, and 

helps fund projects that create or 

preserve quality jobs and/or promote a 

clean rural environment. The financial 

resources are often leveraged with those 

of other public and private credit source 

lenders to meet business and credit 

needs in under-served areas. Recipients 

of these programs may include 

individuals, corporations, partnerships, 

cooperatives, public bodies, nonprofit 

corporations, Indian tribes, and private 

companies. The mission of Cooperative 

Programs of RBS is to promote 

understanding and use of the 

cooperative form of business as a viable 

organizational option for marketing and 

distributing agricultural products. 

Priorities: In support of the 

Department’s goal to increase the 

prosperity of rural communities, RBS 

regulatory priorities will facilitate 

sustainable renewable energy 

development and enhance the 

opportunities necessary for rural 

families to thrive economically. RBS’s 

priority will be to publish regulations to 

fully implement the 2008 Farm Bill. 

This includes promulgating regulations 

for the Biorefinery Assistance Program 

(sec. 9003), the Repowering Assistance 

Program (sec. 9004), the Bioenergy 

Program for Advanced Biofuels (sec. 

9005), and the Rural Microentrepreneur 

Assistance Program (RMAP). RBS has 

been administering sections 9003, 9004, 

and 9005 through the use of Notices of 

Funds Availability and Notices of 

Contract Proposals. Revisions to the 

Rural Energy for America Program (sec. 

9007) will be made to incorporate 

Energy Audits and Renewable Energy 

Development Assistance and Feasibility 

Studies for Rural Energy Systems as 

eligible grant purposes, as well as other 

Farm Bill initiatives and various 

technical changes throughout the rule. 

In addition, revisions to the Business 

and Industry Guaranteed Loan Program 

will be made to implement 2008 Farm 

Bill provisions and other program 

initiatives. These rules will minimize 

program complexity and burden on the 

public while enhancing program 

delivery and RBS oversight. 

Rural Utilities Service 

Mission: The mission of the Rural 

Utilities Service is to improve the 

quality of life in rural America by 

providing investment capital for the 

deployment of critical rural utilities 

telecommunications, electric, and water 

and waste disposal infrastructure. 

Financial assistance is provided to rural 

utilities, municipalities, commercial 

corporations, limited liability 

companies, public utility districts, 

Indian tribes, and cooperative, 

nonprofit, limited-dividend, or mutual 

associations. The public-private 

partnership, which is forged between 

the Rural Utilities Service (RUS) and 

these industries, results in billions of 

dollars in rural infrastructure 

development and creates thousands of 

jobs for the American economy. 

Priorities: RUS’ regulatory priorities 

will be to achieve the President’s goal to 

bring affordable broadband to all rural 

Americans. To accomplish this, RUS 

will continue to improve the Broadband 

Program established by the 2002 Farm 


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Bill. The 2002 Farm Bill authorized RUS 

to approve loans and loan guarantees for 

the costs of construction, improvement, 

and acquisition of facilities and 

equipment for broadband service in 

eligible rural communities. The 2008 

Farm Bill is significantly changing the 

statutory requirements of the Broadband 

Loan Program. As such, RUS will be 

issuing an interim rule to implement the 

statutory changes and will request 

comments on the section of the rule that 

was not part of the proposed rule that 

was published in May 2007. In addition, 

the regulations will be issued to 

implement provisions of the American 

Recovery and Reinvestment Act that 

expanded RUS’s authority to make loans 

and provided new authority to make 

grants to facilitate broadband 

deployment in rural areas. 

Departmental Management 

Mission: Departmental Management’s 

mission is to provide management 

leadership to ensure that USDA 

administrative programs, policies, 

advice, and counsel meet the needs of 

USDA program organizations, consistent 

with laws and mandates, and provide 

safe and efficient facilities and services 

to customers. 

Priorities: In support of the 

Department’s goal to increase rural 

prosperity, USDA’s Departmental 

Management will finalize regulations 

establishing a program allowing 

manufacturers and vendors of eligible 

products made from biobased feedstocks 

to display the label on their packaging 

and marketing materials. Once 

completed, this regulation will 

implement a section of the 2008 Farm 

Bill and will promote alternative uses of 

agriculture and forest materials. 

Aggregate Costs and Benefits 

USDA will ensure that its regulations 

provide benefits that exceed costs, but is 

unable to provide an estimate of the 

aggregated impacts of its regulations. 

Problems with aggregation arise due to 

differing baselines, data gaps, and 

inconsistencies in methodology and the 

type of regulatory costs and benefits 

considered. In addition, aggregation 

omits benefits and costs that cannot be 

reliably quantified, such as improved 

health resulting from increased access to 

more nutritious foods, higher levels of 

food safety, and increased quality of life 

derived from investments in rural 

infrastructure. Some benefits and costs 

associated with rules listed in the 

regulatory plan cannot currently be 

quantified as the rules are still being 

formulated. For 2011, the Department’s 

focus will be to implement the changes 

to programs in such a way as to provide 

benefits while minimizing program 

complexity and regulatory burden for 

program participants. 

USDA—Agricultural Marketing Service 

(AMS) 

PROPOSED RULE STAGE 

1. ∑ WHOLESALE PORK REPORTING 

PROGRAM 

Priority: 

Other Significant 

Legal Authority: 

7 USC 1635 to 1636 

CFR Citation: 

7 CFR 59 

Legal Deadline: 

Final, Statutory, March 28, 2012. 

With the passage of S. 3656, the 

Mandatory Price Reporting Act of 2010, 

the Secretary of Agriculture is required 

to amend chapter 3 of subtitle B of the 

Agricultural Marketing Act of 1946 by 

adding a new section for mandatory 

reporting of wholesale pork cuts. To 

make these amendments, the Secretary 

was directed to promulgate a final rule 

no later than one and a half years after 

the date of the enactment of the Act. 

Accordingly, a final rule will be 

promulgated by March 28, 2012. 

Abstract: 

On September 15, 2010, Congress 

passed the Mandatory Price Reporting 

Act of 2010 reauthorizing Livestock 

Mandatory Reporting for 5 years and 

adding a provision for mandatory 

reporting of wholesale pork cuts. The 

Act was signed by the President on 

September 28, 2010. Congress directed 

the Secretary to engage in negotiated 

rulemaking to make required regulatory 

changes for mandatory wholesale pork 

reporting. Further, Congress required 

that the negotiated rulemaking 

committee include representatives from 

(i) organizations representing swine 

producers; (ii) organizations 

representing packers of pork, processors 

of pork, retailers of pork, and buyers 

of wholesale pork; (iii) the Department 

of Agriculture; and (iv) among 

interested parties that participate in 

swine or pork production. 

Statement of Need: 

Implementation of mandatory pork 

reporting is required by Congress. 

Congress delegated responsibility to the 

Secretary for determining what 

information is necessary and 

appropriate. The Food, Conservation, 

and Energy Act of 2008 (Pub. L. 110- 

234) directed the Secretary to conduct 

a study to determine advantages, 

drawbacks, and potential 

implementation issues associated with 

adopting mandatory wholesale pork 

reporting. The report from this study 

generally concluded that voluntary 

wholesale pork price reporting is thin 

and becoming thinner, and some degree 

of support for moving to mandatory 

price reporting exists at every segment 

of the industry interviewed. The report 

was delivered to Congress on March 25, 

2010. 

Summary of Legal Basis: 

Livestock Mandatory Reporting is 

authorized under the Agricultural 

Marketing Act (7 U.S.C. 1635 to 1636). 

The Livestock and Seed Program of 

USDA’s Agricultural Marketing Service 

has day-to-day responsibility for 

collecting and disseminating LMR data. 

Alternatives: 

There are no alternatives, as this 

rulemaking is a matter of law based on 

the Mandatory Price Reporting Act of 

2010. 

Anticipated Cost and Benefits: 

Estimation of costs will follow the 

previous methodology used in earlier 

Livestock Mandatory Reporting 

rulemaking. The focus of the cost 

estimation is the burden placed on 

reporting companies in providing pork 

marketing data to the Livestock and 

Seed Program. Previous rulemaking 

cost estimates of boxed beef reporting 

of similar data found the burden to be 

an annual total of 65 hours in 

additional reporting requirements per 

firm. Because no official USDA grade 

standards are used in the marketing of 

pork, and fewer cutting styles, the 

burden for pork reporting firms in 

comparison with beef reporting firms 

could be lower. However, the impact 

is not truly known at this stage. 

Timetable: 

Action Date FR Cite 

Notice 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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Agency Contact: 

Warren Preston 

Department of Agriculture 

Agricultural Marketing Service 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 720–6231 

Fax: 202 690–3732 

Email: warren.preston@usda.gov 

RIN: 0581–AD07 

USDA—AMS 

FINAL RULE STAGE 

2. NATIONAL DAIRY PROMOTION 

AND RESEARCH PROGRAM; DAIRY 

IMPORT ASSESSMENTS, DA–08–0050 

Priority: 

Other Significant 

Legal Authority: 

7 USC 4501 to 4514; 7 USC 7401 

CFR Citation: 

7 CFR 1150 

Legal Deadline: 

Final, Statutory, September 19, 2008, 

Assessments on imported dairy 

products must be implemented by 

deadline. 

With the passage of section 1507 in the 

2008 Farm Bill, the Dairy Act was 

amended to apply certain assessments 

to Alaska, Hawaii, the District of 

Columbia, and the Commonwealth of 

Puerto Rico. The 2008 Farm Bill 

authorized the Secretary to issue 

regulations to implement the 

mandatory dairy import assessment 

without providing a notice and 

comment period. However, due to the 

interest of affected parties, a notice and 

comment period was provided. 

Abstract: 

The Dairy Act authorizes the Order for 

dairy product promotion, research, and 

nutrition education as part of a 

comprehensive strategy to increase 

human consumption of milk and dairy 

products and to reduce milk surpluses. 

The program functions to strengthen 

the dairy industry’s position in the 

marketplace by maintaining and 

expanding domestic and foreign 

consumption of fluid milk and dairy 

products. Amendments to the Order are 

pursuant to the 2002 and 2008 Farm 

Bills. The 2002 Farm Bill mandates that 

the Order be amended to implement an 

assessment on imported dairy products 

to fund promotion and research. The 

2008 Farm Bill specifies a mandatory 

assessment rate of 7.5-cent per 

hundredweight of milk, or equivalent 

thereof, on dairy products imported 

into the United States. Additionally, in 

accordance with the 2008 Farm Bill, 

the term ‘‘United States’’ is the Dairy 

Act is amended to mean all States, the 

District of Columbia, and the 

Commonwealth of Puerto Rico. 

Producers in these areas will be 

assessed 15 cents per hundredweight 

for all milk produced and marketed. 

Statement of Need: 

In response to the May 19, 2009 (74 

FR 23359), proposed rule (National 

Dairy Promotion and Research Program; 

Proposed Rule on Amendments to the 

Order), AMS received 189 timely 

comments from consumers, dairy 

producers, foreign governments, 

importers, exporters, manufacturers, 

members of Congress, trade 

associations, and other interested 

parties. 

The comments covered a wide range 

of topics, including 39 in opposition 

to the proposal and 150 in support of 

the proposal. Opponents of the 

proposal expressed concern over the 

lack of a referendum requirement 

among those affected; default 

assessment rates; lack of ability to no 

longer promote State-branded dairy 

products; lack of importer organizations 

eligible to become a Qualified Program; 

disputed the cost-benefit analysis for 

importers and producers; and cited 

unreasonable importer paperwork and 

record keeping burdens. 

Proponents of the proposal expressed 

support for an expedited 

implementation of the dairy import 

assessment; cited the enhanced benefits 

both domestic producers and importers 

will receive as a result of 

implementation; recommended new 

Harmonized Tariff Schedule codes; use 

of a default assessment rate; 

recommended regular reporting of the 

products and assessments on imports; 

and all thresholds for compliance with 

U.S. trade obligations have been met. 

AMS plans to issue a final rule 

implementing the dairy import 

assessment in the near future. In 

response to the comments received and 

after consultation with USTR, AMS is 

addressing, in the final rule, referenda, 

alternative assessment rates, and 

compliance and enforcement activity. 

All remaining changes are 

miscellaneous and minor in nature in 

order to clarify regulatory text. 

Summary of Legal Basis: 

The National Dairy Promotion and 

Research Program (National Program) is 

authorized under the authorized under 

the provisions of the Dairy Production 

Stabilization Act of 1983 (7 U.S.C. 4501 

to 4514), and the Dairy Promotion and 

Research Order (7 CFR part 1150). The 

Dairy Programs unit of USDA’s 

Agricultural Marketing Service has 

day—to—day oversight responsibilities 

for the National Program. 

Alternatives: 

There are no alternatives, as this 

rulemaking is a matter of law based on 

the 2002 and 2008 Farm Bills. 

Anticipated Cost and Benefits: 

Assessments to dairy producers under 

the Order are relatively small compared 

to producer revenue. If dairy producers 

in Alaska, Hawaii, the District of 

Columbia, and the Commonwealth of 

Puerto Rico had paid assessments of 

$0.15 per hundredweight of milk 

marketed in 2007, it is estimated that 

$1.1 million would have been paid. 

This is about 0.6 percent of the $192 

million total value of milk produced 

and marketed in these areas. 

Benefits to producers in these areas are 

assumed to be similar to those benefits 

received by producers of other U.S. 

geographical regions. Cornell University 

has conducted an independent 

economic analysis of the Program that 

is included in the annual report to 

Congress. Cornell determined that from 

1998 through 2007, each dollar 

invested in generic dairy marketing by 

dairy farmers during the period would 

return between $5.52 and $5.94, on 

average, in net revenue to farmers. 

Assessments collected from importers 

under the National Program will be 

relatively small compared to the value 

of dairy imports. If importers had been 

assessed $0.075 per hundredweight, or 

equivalent thereof, for imported dairy 

products in 2007 as specified in this 

rule, it is estimated that less than $6.1 

million would have been paid. This is 

about 0.3 percent of the $2.4 billion 

value of the dairy products imported 

in 2007. 

Risks: 

If the amendments are not 

implemented, USDA would be in 

violation of the 2002 and 2008 Farm 

Bills. 

Timetable: 

Action Date FR Cite 

NPRM 05/19/09 74 FR 23359 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79474 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Action Date FR Cite 

NPRM Comment 

Period End 

06/18/09 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Organizations 

Government Levels Affected: 

None 

Agency Contact: 

Whitney Rick 

Promotion and Research Branch Chief 

Department of Agriculture 

Agricultural Marketing Service 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 720–6909 

Fax: 202 720–0285 

Email: whitney.rick@usda.gov 

RIN: 0581–AC87 

USDA—Animal and Plant Health 

Inspection Service (APHIS) 

PROPOSED RULE STAGE 

3. ANIMAL WELFARE; REGULATIONS 

AND STANDARDS FOR BIRDS 

Priority: 

Other Significant 

Legal Authority: 

7 USC 2131 to 2159 

CFR Citation: 

9 CFR 1 to 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. 

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 and to 

revise the regulations in 9 CFR parts 

1 and 2 to make them applicable to 

birds. 

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 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 

NPRM 08/00/11 

NPRM Comment 

Period End 

11/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Undetermined 

Additional Information: 

Additional information about APHIS 

and its programs is available on the 

Internet at http://www.aphis.usda.gov. 

Agency Contact: 

Johanna Briscoe 

Veterinary Medical Officer and Avian 

Specialist, Animal Care 

Department of Agriculture 

Animal and Plant Health Inspection 

Service 

4700 River Road, Unit 84 

Riverdale, MD 20737–1234 

Phone: 301 734–0658 

RIN: 0579–AC02 

USDA—APHIS 

4. PLANT PEST REGULATIONS; 

UPDATE OF GENERAL PROVISIONS 

Priority: 

Other Significant 

Legal Authority: 

7 USC 450; 7 USC 2260; 7 USC 7701 

to 7772; 7 USC 7781 to 7786; 7 USC 

8301 to 8817; 19 USC 136; 21 USC 111; 

21 USC 114a; 21 USC 136 and 136a; 

31 USC 9701; 42 USC 4331 to 4332 

CFR Citation: 

7 CFR 318 to 319; 7 CFR 330; 7 CFR 

352 

Legal Deadline: 

None 

Abstract: 

We are proposing to revise our 

regulations regarding the movement of 

plant pests. We are proposing to 

regulate the movement of not only 

plant pests, but also biological control 

organisms and associated articles. We 

are proposing risk-based criteria 

regarding the movement of biological 

control organisms, and are proposing to 

exempt certain types of plant pests 

from permitting requirements for their 

interstate movement and movement for 

environmental release. We are also 

proposing to revise our regulations 

regarding the movement of soil, and to 

establish regulations governing the 

biocontainment facilities in which 

plant pests, biological control 

organisms, and associated articles are 

held. This proposed rule replaces a 

previously published proposed rule, 

which we are withdrawing as part of 

this document. This proposal would 

clarify the factors that would be 

considered when assessing the risks 

associated with the movement of 

certain organisms, facilitate the 

movement of regulated organisms and 

articles in a manner that also protects 

U.S. agriculture, and address gaps in 

the current regulations. 

Statement of Need: 

APHIS is preparing a proposed rule to 

revise its regulations regarding the 

movement of plant pests. The revised 

regulations would address the 

importation and interstate movement of 

plant pests, biological control 

organisms, and associated articles and 

the release into the environment of 

biological control organisms. The 

revision would also address the 

movement of soil and establish 

regulations governing the 

biocontainment facilities in which 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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plant pests, biological control 

organisms, and associated articles are 

held. This proposal would clarify the 

factors that would be considered when 

assessing the risks associated with the 

movement of certain organisms, 

facilitate the movement of regulated 

organisms and articles in a manner that 

also protects U.S. agriculture, and 

address gaps in the current regulations. 

Summary of Legal Basis: 

Under section 411(a) of the Plant 

Protection Act (PPA), no person shall 

import, enter, export, or move in 

interstate commerce any plant pest, 

unless the importation, entry, 

exportation, or movement is authorized 

under a general or specific permit and 

in accordance with such regulations as 

the Secretary of Agriculture may issue 

to prevent the introduction of plant 

pests into the United States or the 

dissemination of plant pests within the 

United States. 

Under section 412 of the PPA, the 

Secretary may restrict the importation 

or movement in interstate commerce of 

biological control organisms by 

requiring the organisms to be 

accompanied by a permit authorizing 

such movement and by subjecting the 

organisms to quarantine conditions or 

other remedial measures deemed 

necessary to prevent the spread of plant 

pests or noxious weeds. That same 

section of the PPA also gives the 

Secretary explicit authority to regulate 

the movement of associated articles. 

Alternatives: 

The alternatives we considered were 

taking no action at this time or 

implementing a comprehensive risk 

reduction plan. This latter alternative 

would be characterized as a broad risk 

mitigation strategy that could involve 

various options such as increased 

inspection, regulations specific to a 

certain organism or group of related 

organisms, or extensive biocontainment 

requirements. 

We decided against the first alternative 

because leaving the regulations 

unchanged would not address the 

needs identified immediately above. 

We decided against the latter 

alternative, because available scientific 

information, personnel, and resources 

suggest that it would be impracticable 

at this time. 

Anticipated Cost and Benefits: 

Undetermined at this time. 

Risks: 

Unless we issue such a proposal, the 

regulations will not provide a clear 

protocol for obtaining permits that 

authorize the movement and 

environmental release of biological 

control organisms. This, in turn, could 

impede research to explore biological 

control options for various plant pests 

and noxious weeds known to exist 

within the United States, and could 

indirectly lead to the further 

dissemination of such pests and weeds. 

Moreover, unless we revise the soil 

regulations, certain provisions in the 

regulations will not adequately address 

the risk to plants, plant parts, and plant 

products within the United States that 

such soil might present. 

Timetable: 

Action Date FR Cite 

Notice of Intent to 

Prepare an 

Environmental 

Impact Statement 

10/20/09 74 FR 53673 

Notice Comment 

Period End 

11/19/09 

NPRM 01/00/11 

NPRM Comment 

Period End 

03/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Organizations 

Government Levels Affected: 

Local, State, Tribal 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Additional Information: 

Additional information about APHIS 

and its programs is available on the 

Internet at http://www.aphis.usda.gov. 

Agency Contact: 

Shirley Wager–Page 

Chief, Pest Permitting Branch, Plant 

Health Programs, PPQ 

Department of Agriculture 

Animal and Plant Health Inspection 

Service 

4700 River Road, Unit 131 

Riverdale, MD 20737–1236 

Phone: 301 734–8453 

RIN: 0579–AC98 

USDA—APHIS 

5. ∑ IMPORTATION OF LIVE DOGS 

Priority: 

Other Significant 

Legal Authority: 

7 USC 2148 

CFR Citation: 

9 CFR 1 and 2 

Legal Deadline: 

None 

Abstract: 

This rulemaking would amend the 

Animal Welfare Act (AWA) regulations 

to regulate dogs imported for resale as 

required by a recent amendment to the 

AWA. Importation of dogs for resale 

would be prohibited unless the dogs 

are in good health, have all necessary 

vaccinations, and are 6 months of age 

or older. This proposal will also reflect 

the exemptions provided in the 

amendment to the AWA for dogs 

imported for research purposes or 

veterinary treatment and for dogs 

legally imported into the State of 

Hawaii from the British Isles, Australia, 

Guam, or New Zealand. 

Statement of Need: 

The Food, Conservation, and Energy 

Act of 2008 mandates that the Secretary 

of Agriculture promulgate regulations 

to implement and enforce new 

provisions of the Animal Welfare Act 

(AWA) regarding the importation of 

dogs for resale. In line with the changes 

to the AWA, APHIS intends to amend 

the regulations in 9 CFR parts 1 and 

2 to regulate the importation of dogs 

for resale. 

Summary of Legal Basis: 

The Food, Conservation, and Energy 

Act of 2008 (Pub. L. 110-246, signed 

into law on June 18, 2008) added a new 

section to the Animal Welfare Act (7 

U.S.C. 2147) to restrict the importation 

of live dogs for resale. As amended, the 

AWA now prohibits the importation of 

dogs into the United States for resale 

unless the Secretary of Agriculture 

determines that the dogs are in good 

health, have received all necessary 

vaccinations, and are at least 6 months 

of age. Exceptions are provided for dogs 

imported for research purposes or 

veterinary treatment. An exception to 

the 6-month age requirement is also 

provided for dogs that are lawfully 

imported into Hawaii for resale 

purposes from the British Isles, 

Australia, Guam, or New Zealand in 

compliance with the applicable 

regulations of Hawaii, provided the 

dogs are vaccinated, are in good health, 

and are not transported out of Hawaii 

for resale purposes at less than 6 

months of age. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79476 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Alternatives: 

To be identified. 

Anticipated Cost and Benefits: 

To be determined. 

Risks: 

Not applicable. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

NPRM Comment 

Period End 

02/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

None 

Additional Information: 

Additional information about APHIS 

and its programs is available on the 

Internet at http://www.aphis.usda.gov. 

Agency Contact: 

Gerald Rushin 

Veterinary Medical Officer, Animal Care 

Department of Agriculture 

Animal and Plant Health Inspection 

Service 

4700 River Road, Unit 84 

Riverdale, MD 20737–1234 

Phone: 301 734–0954 

RIN: 0579–AD23 

USDA—APHIS 

6. ∑ ANIMAL DISEASE TRACEABILITY 

Priority: 

Other Significant 

Legal Authority: 

7 USC 8305 

CFR Citation: 

9 CFR 90 

Legal Deadline: 

None 

Abstract: 

This rulemaking would establish a new 

part in the Code of Federal Regulations 

containing general identification and 

documentation requirements for 

livestock moving interstate. The 

purpose of the new regulations is to 

improve our ability to trace livestock 

in the event that disease is found. The 

regulations will provide national 

traceability standards for livestock 

moved interstate and allow each State 

and tribe the flexibility to develop ways 

of meeting the standards that will work 

best for them. 

Statement of Need: 

Preventing and controlling animal 

disease is the cornerstone of protecting 

American animal agriculture. While 

ranchers and farmers work hard to 

protect their animals and their 

livelihoods, there is never a guarantee 

that their animals will be spared from 

disease. To support their efforts, USDA 

has enacted regulations to prevent, 

control, and eradicate disease, and to 

increase foreign and domestic 

confidence in the safety of animals and 

animal products. Traceability helps 

give that reassurance. Traceability does 

not prevent disease, but knowing where 

diseased and at-risk animals are, where 

they have been, and when, is 

indispensable in emergency response 

and in ongoing disease programs. The 

primary objectives of these proposed 

regulations are to improve our ability 

to trace livestock in the event that 

disease is found and to provide 

national standards to ensure the smooth 

flow of livestock in interstate 

commerce, while also allowing States 

and tribes the flexibility to develop 

systems for tracing animals within their 

State and tribal lands that work best 

for them. 

Summary of Legal Basis: 

Under the Animal Health Protection 

Act (7 U.S.C. 8301 et seq.), the 

Secretary of Agriculture may prohibit 

or restrict the interstate movement of 

any animal to prevent the introduction 

or dissemination of any pest or disease 

of livestock, and may carry out 

operations and measures to detect, 

control, or eradicate any pest or disease 

of livestock. The Secretary may 

promulgate such regulations as may be 

necessary to carry out the Act. 

Alternatives: 

As part of its ongoing efforts to 

safeguard animal health, APHIS 

initiated implementation of the 

National Animal Identification System 

(NAIS) in 2004. More recently, the 

Agency launched an effort to assess the 

level of acceptance of NAIS through 

meetings with the Secretary, listening 

sessions in 14 cities, and public 

comments. Although there was some 

support for NAIS, the vast majority of 

participants were highly critical of the 

program and of USDA’s 

implementation efforts. The feedback 

revealed that NAIS has become a 

barrier to achieving meaningful animal 

disease traceability in the United States 

in partnership with America’s 

producers. 

The option we are proposing pertains 

strictly to interstate movement and 

gives States and tribes the flexibility to 

identify and implement the traceability 

approaches that work best for them. 

Anticipated Cost and Benefits: 

A workable and effective animal 

traceability system would enhance 

animal health programs, leading to 

more secure market access and other 

societal gains. Traceability can reduce 

the cost of disease outbreaks, 

minimizing losses to producers and 

industries by enabling current and 

previous locations of potentially 

exposed animals to be readily 

identified. Trade benefits can include 

increased competitiveness in global 

markets generally, and when outbreaks 

do occur, the mitigation of export 

market losses through regionalization. 

Markets benefit through more efficient 

and timely epidemiological 

investigation of animal health issues. 

Other societal benefits include 

improved animal welfare during natural 

disasters. 

Costs of an animal traceability system 

would include those for tags and 

tagging and would vary, depending on 

the method of identification chosen 

(e.g., metal tags vs. microchip 

implants). Costs are expected to vary 

by both type of operation and whether 

traceability would be by individual 

animal or by lot or group. Per head 

costs of traceability programs for the 

principal farm animals are estimated to 

be highest for cattle operations, 

followed by sheep, swine, and poultry 

operations. Larger operations would 

likely reap economies of scale, that is, 

incur lower costs per head than smaller 

operations. However, there will be 

exemptions for small producers who 

raise animals to feed themselves, their 

families, and their immediate 

neighbors. In addition, only operations 

moving livestock interstate would be 

required to comply with the 

regulations. 

Risks: 

This rulemaking is being undertaken to 

address the animal health risks posed 

by gaps in the existing regulations 

concerning identification of livestock 

being moved interstate. The current 

lack of a comprehensive animal 

traceability program is impairing our 

ability to trace animals that may be 

affected with disease. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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Timetable: 

Action Date FR Cite 

NPRM 04/00/11 

NPRM Comment 

Period End 

06/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

State, Tribal 

Additional Information: 

Additional information about APHIS 

and its programs is available on the 

Internet at http://www.aphis.usda.gov. 

Agency Contact: 

Neil Hammerschmidt 

NAIS Coordinator, Surveillance and 

Identification Programs, NCAHP, VS 

Department of Agriculture 

Animal and Plant Health Inspection 

Service 

4700 River Road, Unit 200 

Riverdale, MD 20737–1231 

Phone: 301 734–5571 

RIN: 0579–AD24 

USDA—APHIS 

FINAL RULE STAGE 

7. IMPORTATION OF PLANTS FOR 

PLANTING; ESTABLISHING A NEW 

CATEGORY OF PLANTS FOR 

PLANTING NOT AUTHORIZED FOR 

IMPORTATION PENDING PEST RISK 

ANALYSIS (RULEMAKING RESULTING 

FROM A SECTION 610 REVIEW) 

Priority: 

Other Significant 

Legal Authority: 

7 USC 450; 7 USC 7701 to 7772; 7 USC 

7781 to 7786; 21 USC 136 and 136a 

CFR Citation: 

7 CFR 319 

Legal Deadline: 

None 

Abstract: 

This rulemaking will amend the 

regulations to establish a new category 

of regulated articles in the regulations 

governing the importation of nursery 

stock, also known as plants for 

planting. This category will list taxa of 

plants for planting whose importation 

is not authorized pending pest risk 

analysis. If scientific evidence indicates 

that a taxon of plants for planting is 

a quarantine pest or a host of a 

quarantine pest, we will publish a 

notice that will announce our 

determination that the taxon is a 

quarantine pest or a host of a 

quarantine pest, cite the scientific 

evidence we considered in making this 

determination, and give the public an 

opportunity to comment on our 

determination. If we receive no 

comments that change our 

determination, the taxon will 

subsequently be added to the new 

category. We will allow any person to 

petition for a pest risk analysis to be 

conducted for a taxon that has been 

added to the new category. After the 

pest risk analysis is completed, we will 

remove the taxon from the category and 

allow its importation subject to general 

requirements, allow its importation 

subject to specific restrictions, or 

prohibit its importation. We will 

consider applications for permits to 

import small quantities of germplasm 

from taxa whose importation is not 

authorized pending pest risk analysis, 

for experimental or scientific purposes 

under controlled conditions. This new 

category will allow us to take prompt 

action on evidence that the importation 

of a taxon of plants for planting poses 

a risk while continuing to allow for 

public participation in the process. 

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 U.S.C. 

7712). 

Alternatives: 

APHIS has identified one alternative to 

the approach we are considering. We 

could prohibit the importation of all 

nursery stock pending risk evaluation, 

approval, and notice-and-comment 

rulemaking, similar to APHIS’ approach 

to regulating imported fruits and 

vegetables. 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: 

Undetermined. 

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 

NPRM 07/23/09 74 FR 36403 

NPRM Comment 

Period End 

10/21/09 

Final Rule 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Additional Information: 

Additional information about APHIS 

and its programs is available on the 

Internet at http://www.aphis.usda.gov. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79478 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Agency Contact: 

Arnold T. Tschanz 

Senior Plant Pathologist, Risk 

Management and Plants for Planting 

Policy, RPM, PPQ 

Department of Agriculture 

Animal and Plant Health Inspection 

Service 

4700 River Road, Unit 133 

Riverdale, MD 20737–1231 

Phone: 301 734–0627 

RIN: 0579–AC03 

USDA—Rural Housing Service (RHS) 

FINAL RULE STAGE 

8. MULTI–FAMILY HOUSING (MFH) 

REINVENTION 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

5 USC 301; 42 USC 1490a; 7 USC 1989; 

42 USC 1475; 42 USC 1479; 42 USC 

1480; 42 USC 1481; 42 USC 1484; 42 

USC 1485; 42 USC 1486 

CFR Citation: 

7 CFR 1806; 7 CFR 1822; 7 CFR 1902; 

7 CFR 1925; 7 CFR 1930; 7 CFR 1940; 

7 CFR 1942; 7 CFR 1944; 7 CFR 1951; 

7 CFR 1955; 7 CFR 1956; 7 CFR 1965; 

7 CFR 3560; 7 CFR 3565 

Legal Deadline: 

None 

Abstract: 

The Rural Housing Service has 

consolidated and streamlined the 

regulations pertaining to section 515 

Rural Rental Housing, section 514 Farm 

Labor Housing Loans, section 516 Farm 

Labor Housing Grants, and section 521 

Rental Assistance Payments. Fourteen 

published regulations have been 

reduced to one regulation and 

handbooks for program administration. 

This will simplify loan origination and 

portfolio management for applicants, 

borrowers, and housing operators, as 

well as Rural Development field staff. 

This also provides flexibility for 

program modifications to reflect current 

and foreseeable changes. The 

consolidated regulations save time and 

simplify costs. Finally, the regulation 

is more customer friendly and 

responsive to the needs of the public. 

Statement of Need: 

The new regulation for the program 

known as the Multi-Family Housing 

Loan and Grant Programs will be more 

user-friendly for lenders, borrowers, 

and Agency staff. These changes are 

essential to allow for improved service 

to the public and for an expanded 

program with increased impact on rural 

housing opportunities without a 

corresponding expansion in Agency 

staff. The regulations will be shorter, 

better organized, and more simple and 

clear. Many documentation 

requirements will be eliminated or 

consolidated into more convenient 

formats. 

Summary of Legal Basis: 

The existing statutory authority for the 

MFH programs was established in title 

V of the Housing Act of 1949, which 

gave authority to the RHS (then the 

Farmers Home Administration) to make 

housing loans to farmers. As a result 

of this Act, the Agency established 

single-family and multi-family housing 

programs. Over time, the sections of the 

Housing Act of 1949 addressing MFH 

have been amended a number of times. 

Amendments have involved issues such 

as the provision of interest credit, 

broadening definitions of eligible areas 

and populations to be served, 

participation of limited profit entities, 

the establishment of a rental assistance 

program, and the imposition of a 

number of restrictive use provisions 

and prepayment restrictions. 

Alternatives: 

To not publish the rule would 

substantially restrict RHS’ ability to 

effectively administer the programs and 

cost the Agency significant credibility 

with the public and oversight 

organizations. 

Anticipated Cost and Benefits: 

Based on analysis of the proposed rule, 

the following impacts may occur, some 

of which could be considered 

significant: 

There would be cost savings due to 

reduced paperwork, estimated to be 

about $1.8 million annually for the 

public and about $10.1 million for the 

Government. 

Risks: 

Without the streamlining, there will be 

a decrease in the ability of the Agency 

to provide safe, decent, and sanitary 

housing to program beneficiaries. 

Timetable: 

Action Date FR Cite 

NPRM 06/02/03 68 FR 32872 

Action Date FR Cite 

NPRM Comment 

Period End 

08/01/03 

Interim Final Rule 11/26/04 69 FR 69032 

Interim Final Rule 

Comment Period 

End 

12/27/04 

Interim Final Rule 

Effective 

02/22/05 70 FR 8503 

Final Action 10/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

None 

Agency Contact: 

Laurence Anderson 

MFH Preservation and Direct Loans 

Department of Agriculture 

Rural Housing Service 

STOP 0781 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 720–1611 

Email: laurence.anderson@wdc.usda.gov 

Related RIN: Merged with 0575–AC24 

RIN: 0575–AC13 

USDA—Grain Inspection, Packers and 

Stockyards Administration (GIPSA) 

FINAL RULE STAGE 

9. ENFORCEMENT OF THE PACKERS 

AND STOCKYARDS ACT 

Priority: 

Other Significant 

Legal Authority: 

7 USC 181 

CFR Citation: 

9 CFR 201 

Legal Deadline: 

Final, Statutory, June 18, 2010. 

Abstract: 

GIPSA is proposing regulations under 

the Packers and Stockyards Act, 1921, 

that clarify when certain conduct in the 

livestock and poultry industries 

represents the making or giving of an 

undue or unreasonable preference or 

advantage or subjects a person or 

locality to an undue or unreasonable 

prejudice or disadvantage. These 

proposed regulations also establish 

criteria GIPSA will consider in 

determining whether a live poultry 


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dealer has provided reasonable notice 

to poultry growers of any suspension 

of the delivery of birds under a poultry 

growing arrangement; when a 

requirement of additional capital 

investments over the life of a poultry 

growing arrangement or swine 

production contract constitutes a 

violation of the P&S Act; and whether 

a live poultry dealer or swine 

contractor has provided a reasonable 

period of time for a poultry grower or 

a swine production contract grower to 

remedy a breach of contract that could 

lead to termination of the poultry 

growing arrangement or swine 

production contract. The Farm Bill also 

instructed the Secretary to promulgate 

regulations to ensure that producers 

and growers are afforded the 

opportunity to fully participate in the 

arbitration process if they so choose. 

Statement of Need: 

In enacting title XI of the Food, 

Conservation, and Energy Act of 2008 

(Farm Bill) (Pub. L. 110-246), Congress 

recognized the nature of problems 

encountered in the livestock and 

poultry industries and amended the 

Packers and Stockyards Act (P&S Act). 

These amendments established new 

requirements for participants in the 

livestock and poultry industries and 

required the Secretary of Agriculture 

(Secretary) to establish criteria to 

consider when determining that certain 

other conduct is in violation of the P&S 

Act. 

The Grain Inspection, Packers and 

Stockyards Administration’s (GIPSA) 

attempts to enforce the broad 

prohibitions of the P&S Act have been 

frustrated, in part because it has not 

previously defined what conduct 

constitutes an unfair practice or the 

giving of an undue preference or 

advantage. The new regulations that 

GIPSA is proposing describe and clarify 

conduct that violates the P&S Act and 

allow for more effective and efficient 

enforcement by GIPSA. They will 

clarify conditions for industry 

compliance with the P&S Act and 

provide for a fairer market place. 

In accordance with the Farm Bill, 

GIPSA is proposing regulations under 

the P&S Act that would clarify when 

certain conduct in the livestock and 

poultry industries represents the 

making or giving of an undue or 

unreasonable preference or advantage 

or subjects a person or locality to an 

undue or unreasonable prejudice or 

disadvantage. These proposed 

regulations also establish criteria that 

GIPSA will consider in determining 

whether a live poultry dealer has 

provided reasonable notice to poultry 

growers of a suspension of the delivery 

of birds under a poultry growing 

arrangement; when a requirement of 

additional capital investments over the 

life of a poultry growing arrangement 

or swine production contract 

constitutes a violation of the P&S Act; 

and whether a packer, swine contractor 

or live poultry dealer has provided a 

reasonable period of time for a grower 

or a swine producer to remedy a breach 

of contract that could lead to 

termination of the growing arrangement 

or production contract. 

The Farm Bill also instructed the 

Secretary to promulgate regulations to 

ensure that poultry growers, swine 

production contract growers and 

livestock producers are afforded the 

opportunity to fully participate in the 

arbitration process, if they so choose. 

We are proposing a required format for 

providing poultry growers, swine 

production contract growers, and 

livestock producers the opportunity to 

decline the use of arbitration in 

contracts requiring arbitration. We are 

also proposing criteria that we will 

consider in finding that poultry 

growers, swine production contract 

growers, and livestock producers have 

a meaningful opportunity to participate 

fully in the arbitration process if they 

voluntarily agree to do so. We will use 

these criteria to assess the overall 

fairness of the arbitration process. 

In addition to proposing regulations in 

accordance with the Farm Bill, GIPSA 

is proposing regulations that would 

prohibit certain conduct because it is 

unfair, unjustly discriminatory or 

deceptive, in violation of the P&S Act. 

These additional proposed regulations 

are promulgated under the authority of 

section 407 of the P&S Act and 

complement those required by the Farm 

Bill to help ensure fair trade and 

competition in the livestock and 

poultry industries. 

These regulations are intended to 

address the increased use of contracting 

in the marketing and production of 

livestock and poultry by entities under 

the jurisdiction of the P&S Act, and 

practices that result from the use of 

market power and alterations in private 

property rights, which violate the spirit 

and letter of the P&S Act. The effect 

increased contracting has had, and 

continues to have, on individual 

agricultural producers has significantly 

changed the industry and the rural 

economy as a whole, making these 

proposed regulations necessary. 

Summary of Legal Basis: 

Section 407 of the P&S Act (7 U.S.C. 

228) provides that the Secretary ‘‘may 

make such rules, regulations, and 

orders as may be necessary to carry out 

the provisions of this Act.’’ Sections 

11005 and 11006 of the Farm Bill 

became effective June 18, 2008, and 

instruct the Secretary to promulgate 

additional regulations as described in 

this notice of proposed rulemaking. 

Alternatives: 

The Farm Bill explicitly directs the 

Secretary to promulgate certain 

regulations. GIPSA determined that 

additional regulations are necessary to 

provide notice to all regulated entities 

of types of practices and conduct that 

GIPSA considers ‘‘unfair’’ so that 

regulated entities are fully informed of 

actions or practices that are considered 

‘‘unfair’’ and, therefore, prohibited. 

Within both the mandatory and 

discretionary regulatory provisions, we 

considered alternative options. 

For example, GIPSA considered shorter 

notice periods in situations when a live 

poultry dealer suspends delivery of 

birds to a poultry grower. These 

alternatives would not have provided 

adequate trust and integrity in the 

livestock and poultry markets. Other 

alternatives may have been more 

restrictive. We considered prohibiting 

the use of arbitration to resolve 

disputes; however, that option goes 

against a popular method of dispute 

resolution in other industries and is not 

in line with the spirit of the 2008 Farm 

Bill. GIPSA believes that this proposed 

rule represents the best option to level 

the playing field between packers, 

swine contractors, live poultry dealers, 

and the Nation’s poultry growers, swine 

production contract growers, or 

livestock producers for the benefit of 

more efficient marketing and public 

good. 

Anticipated Cost and Benefits: 

Costs: 

Costs are aggregated into three major 

types: 1) Administrative costs, which 

include items such as office work, 

postage, filing, and copying; 2) costs of 

analysis, such as a business conducting 

a profit-loss analysis; and 3) adjustment 

costs, such as costs related to changing 

business behavior to achieve 

compliance with the proposed 

regulation. 

Benefits: 

Benefits are also aggregated into three 

major groups: 1) Increased pricing 


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efficiency; 2) allocation efficiency; and 

3) competitive efficiency. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 06/22/10 75 FR 35338 

NPRM Comment 

Period End 

08/23/10 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Agency Contact: 

H. Tess Butler 

Regulatory Liaison 

Department of Agriculture 

Grain Inspection, Packers and Stockyards 

Administration 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 720–7486 

Fax: 202 690–2173 

Email: h.tess.butler@usda.gov 

RIN: 0580–AB07 

USDA—Food and Nutrition Service 

(FNS) 

PROPOSED RULE STAGE 

10. ELIGIBILITY, CERTIFICATION, AND 

EMPLOYMENT AND TRAINING 

PROVISIONS OF THE FOOD, 

CONSERVATION, AND ENERGY ACT 

OF 2008 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

PL 110–246; PL 104–121 

CFR Citation: 

7 CFR 273 

Legal Deadline: 

None 

Abstract: 

This proposed rule would amend the 

regulations governing the Supplemental 

Nutrition Assistance Program (SNAP) to 

implement provisions from the Food, 

Conservation, and Energy Act of 2008 

(Pub. L. 110-246) (FCEA) concerning 

the eligibility and certification of SNAP 

applicants and participants and SNAP 

employment and training. In addition, 

this proposed rule would revise the 

SNAP regulations throughout 7 CFR 

part 273 to change the program name 

from the Food Stamp Program to SNAP 

and to make other nomenclature 

changes as mandated by the FCEA. The 

statutory effective date of these 

provisions was October 1, 2008. Food 

and Nutrition Service (FNS) is also 

proposing two discretionary revisions 

to SNAP regulations to provide State 

agencies options that are currently 

available only through waivers. These 

provisions would allow State agencies 

to average student work hours and to 

provide telephone interviews in lieu of 

face-to-face interviews. FNS anticipates 

that this rule would impact the 

associated paperwork burdens (08-006). 

Statement of Need: 

This proposed rule would amend the 

regulations governing SNAP to 

implement provisions from the FCEA 

concerning the eligibility and 

certification of SNAP applicants and 

participants and SNAP employment 

and training. In addition, this proposed 

rule would revise the SNAP regulations 

throughout 7 CFR part 273 to change 

the program name from the Food Stamp 

Program to SNAP and to make other 

nomenclature changes as mandated by 

the FCEA. The statutory effective date 

of these provisions was October 1, 

2008. FNS is also proposing 2 

discretionary revisions to SNAP 

regulations to provide State agencies 

options that are currently available only 

through waivers. These provisions 

would allow State agencies to average 

student work hours and to provide 

telephone interviews in lieu of face-toface interviews. FNS anticipates that 

this rule would impact the associated 

paperwork burdens. 

Summary of Legal Basis: 

Food, Conservation, and Energy Act of 

2008 (Pub. L. 110-246). 

Alternatives: 

Because this proposed rule is under 

development, alternatives are not yet 

articulated. The rule would implement 

statutory requirements set forth by the 

Food, Conservation, and Energy Act of 

2008 concerning SNAP eligibility and 

certification rules. 

Anticipated Cost and Benefits: 

FNS is currently developing estimates 

of the anticipated costs and benefits of 

this rule. Anticipated principle effects 

would be on paperwork burdens. 

Risks: 

The statutory changes and discretionary 

ones under consideration would 

streamline program operations. The 

changes are expected to reduce the risk 

of inefficient operations. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Local, State 

Agency Contact: 

James F. Herbert 

Regulatory Review Specialist 

Department of Agriculture 

Food and Nutrition Service 

10th Floor 

3101 Park Center Drive 

Alexandria, VA 22302 

Phone: 703 305–2572 

Email: james.herbert@fns.usda.gov 

RIN: 0584–AD87 

USDA—FNS 

11. SUPPLEMENTAL NUTRITION 

ASSISTANCE PROGRAM: FARM BILL 

OF 2008 RETAILER SANCTIONS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

PL 110–246 

CFR Citation: 

7 CFR 276 

Legal Deadline: 

None 

Abstract: 

This proposed rule would implement 

provisions under section 4132 of the 

Food, Conservation, and Energy Act of 

2008, also referred to as the Farm Bill 

of 2008. Under section 4132, the 

Department of Agriculture’s Food and 

Nutrition Service (FNS) is provided 

with greater authority and flexibility 

when sanctioning retail or wholesale 

food stores that violate Supplemental 

Nutrition Assistance Program (SNAP) 

rules. Specifically, the Department is 

authorized to assess a civil penalty and 

to disqualify a retail or wholesale food 


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store authorized to participate in SNAP. 

Previously, the Department could 

assess a civil penalty or 

disqualification, but not both. Section 

4132 also eliminates the minimum 

disqualification period which was 

previously set at 6 months. 

In addition to implementing statutory 

provisions, this rule proposes to 

provide a clear administrative penalty 

when an authorized retailer or 

wholesale food store redeems a SNAP 

participant’s Program benefits without 

the knowledge of the participant. All 

Program benefits are issued through the 

Electronic Benefits Transfer (EBT) 

system. The EBT system establishes 

data that may be used to identify fraud 

committed by retail food stores. While 

stealing Program benefits could be 

prosecuted under current statute, 

Program regulations do not provide a 

clear penalty for these thefts. The 

proposed rule would establish an 

administrative penalty for such thefts 

equivalent to the penalty for trafficking 

in Program benefits, which is the 

permanent disqualification of a retailer 

or wholesale food store from SNAP 

participation. 

Finally, the Department proposes to 

identify additional administrative retail 

violations and the associated sanction 

that would be imposed against the 

retail food store for committing the 

violation. For instance, to maintain 

integrity, FNS requires retail and 

wholesale food stores to key enter EBT 

card data in the presence of the actual 

EBT card. 

The proposed rule would codify this 

requirement and identify the specific 

sanction that would be imposed if retail 

food stores are found to be in violation 

(08-007). 

Statement of Need: 

This proposed rule would implement 

provisions under section 4132 of the 

Food, Conservation, and Energy Act of 

2008, also referred to as the Farm Bill 

of 2008. Under section 4132, the 

Department of Agriculture’s Food and 

Nutrition Service (FNS) is provided 

with greater authority and flexibility 

when sanctioning retail or wholesale 

food stores that violate Supplemental 

Nutrition Assistance Program (SNAP) 

rules. Specifically, the Department is 

authorized to assess a civil penalty and 

to disqualify a retail or wholesale food 

store authorized to participate in SNAP. 

Previously, the Department could 

assess a civil penalty or 

disqualification, but not both. Section 

4132 also eliminates the minimum 

disqualification period which was 

previously set at six months. In 

addition to implementing statutory 

provisions, this rule proposes to 

provide a clear administrative penalty 

when an authorized retailer or 

wholesale food store redeems a SNAP 

participant’s Program benefits without 

the knowledge of the participant. All 

Program benefits are issued through the 

Electronic Benefits Transfer (EBT) 

system. The EBT system establishes 

data that may be used to identify fraud 

committed by retail food stores. While 

stealing Program benefits could be 

prosecuted under current statute, 

Program regulations do not provide a 

clear penalty for these thefts. The 

proposed rule would establish an 

administrative penalty for such thefts 

equivalent to the penalty for trafficking 

in Program benefits, which is the 

permanent disqualification of a retailer 

or wholesale food store from SNAP 

participation. Finally, the Department 

proposes to identify additional 

administrative retail violations and the 

associated sanction that would be 

imposed against the retail food store for 

committing the violation. For instance, 

to maintain integrity, FNS requires 

retail and wholesale food stores to key 

enter EBT card data in the presence of 

the actual EBT card. The proposed rule 

would codify this requirement and 

identify the specific sanction that 

would be imposed if retail food stores 

are found to be in violation. 

Summary of Legal Basis: 

Section 4132, Food, Conservation, and 

Energy Act of 2008 (Pub. L. 110-246). 

Alternatives: 

Because this proposed rule is under 

development alternatives are not yet 

articulated. 

Anticipated Cost and Benefits: 

Because this proposed rule is under 

development anticipated costs and 

benefits have not yet been articulated. 

Risks: 

The risk that retail or wholesale food 

stores will violate SNAP rules, or 

continue to violate SNAP rules, is 

expected to be reduced by refining 

program sanctions for participating 

retailers and wholesalers. 

Timetable: 

Action Date FR Cite 

NPRM 09/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Additional Information: 

Note: This RIN replaces the previously 

issued RIN 0584-AD78. 

Agency Contact: 

James F. Herbert 

Regulatory Review Specialist 

Department of Agriculture 

Food and Nutrition Service 

10th Floor 

3101 Park Center Drive 

Alexandria, VA 22302 

Phone: 703 305–2572 

Email: james.herbert@fns.usda.gov 

RIN: 0584–AD88 

USDA—FNS 

12. FRESH FRUIT AND VEGETABLE 

PROGRAM 

Priority: 

Other Significant 

Legal Authority: 

Food, Conservation, and Energy Act of 

2008; National School Lunch Act 

(NSLA); 42 USC 1769(a) 

CFR Citation: 

7 CFR 211 

Legal Deadline: 

None 

Abstract: 

The Food, Conservation, and Energy 

Act of 2008 amended the National 

School Lunch Act (NSLA) to add 

section 19, the Fresh Fruit and 

Vegetable Program (FFVP). Section 19 

establishes the FFVP as a permanent 

national program in a select number of 

schools in each State, the District of 

Columbia, Guam, Puerto Rico, and the 

Virgin Islands. Schools in all States 

must apply annually for FFVP funding. 

This proposed rule would implement 

statutory requirements currently 

established through program policy and 

guidance for operators at the State and 

local level. The proposed rule would 

set forth requirements detailed in the 

statute for school selection and 

participation, State agency outreach to 

needy schools, the yearly application 

process, and the funding and allocation 

processes for schools and States. The 

proposed rule would also include the 

statutory per student funding range and 

the requirement for a program 

evaluation. 


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In addition, the proposed rule would 

establish oversight activity and 

reporting and recordkeeping 

requirements that are not included in 

FFVP statutory requirements. 

Implementation of this rule is not 

expected to result in expenses for 

program operators because they receive 

funding to cover food purchases and 

administrative costs (09-007). 

Statement of Need: 

The Food, Conservation, and Energy 

Act of 2008 amended the National 

School Lunch Act (NSLA) to add 

section 19, the Fresh Fruit and 

Vegetable Program (FFVP). Section 19 

establishes the FFVP as a permanent 

national program in a select number of 

schools in each State, the District of 

Columbia, Guam, Puerto Rico, and the 

Virgin Islands. Schools in all States 

must apply annually for FFVP funding. 

This proposed rule would implement 

statutory requirements currently 

established through program policy and 

guidance for operators at the State and 

local level. The proposed rule would 

set forth requirements detailed in the 

statute for school selection and 

participation, State agency outreach to 

needy schools, the yearly application 

process, and the funding and allocation 

processes for schools and States. The 

proposed rule would also include the 

statutory per student funding range and 

the requirement for a program 

evaluation. 

Summary of Legal Basis: 

Section 19, Food, Conservation, and 

Energy Act of 2008. National School 

Lunch Act (NSLA). 42 U.S.C. 1769(a). 

Alternatives: 

Because this proposed rule is under 

development, alternatives are not yet 

articulated. The rule would implement 

statutory requirements set forth by the 

Food, Conservation, and Energy Act of 

2008 by adding section 19, the Fresh 

Fruit and Vegetable Program (FFVP), to 

the National School Lunch Act. 

Alternatives to this process are not 

known or being pursued at this time. 

Anticipated Cost and Benefits: 

Implementation of this rule is not 

expected to result in expenses for 

program operators because they receive 

funding to cover food purchases and 

administrative costs. 

Risks: 

No risks by implementing this 

proposed rule have been identified at 

this time. 

Timetable: 

Action Date FR Cite 

NPRM 02/00/11 

NPRM Comment 

Period End 

04/00/11 

Final Action 08/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Local, State 

Agency Contact: 

James F. Herbert 

Regulatory Review Specialist 

Department of Agriculture 

Food and Nutrition Service 

10th Floor 

3101 Park Center Drive 

Alexandria, VA 22302 

Phone: 703 305–2572 

Email: james.herbert@fns.usda.gov 

RIN: 0584–AD96 

USDA—FNS 

FINAL RULE STAGE 

13. CHILD AND ADULT CARE FOOD 

PROGRAM: IMPROVING 

MANAGEMENT AND PROGRAM 

INTEGRITY 

Priority: 

Other Significant 

Legal Authority: 

42 USC 1766; PL 103–448; PL 104–193; 

PL 105–336 

CFR Citation: 

7 CFR 226 

Legal Deadline: 

None 

Abstract: 

This rule amends the Child and Adult 

Care Food Program (CACFP) 

regulations. The changes in this rule 

result from the findings of State and 

Federal program reviews and from 

audits and investigations conducted by 

the Office of Inspector General. This 

rule revises: State agency criteria for 

approving and renewing institution 

applications; program training and 

other operating requirements for child 

care institutions and facilities; and 

State and institution-level monitoring 

requirements. This rule also includes 

changes that are required by the 

Healthy Meals for Healthy Americans 

Act of 1994 (Pub. L. 103-448), the 

Personal Responsibility and Work 

Opportunities Reconciliation Act of 

1996 (Pub. L. 104-193), and the William 

F. Goodling Child Nutrition 

Reauthorization Act of 1998 (Pub. L. 

105-336). 

The changes are designed to improve 

program operations and monitoring at 

the State and institution levels and, 

where possible, to streamline and 

simplify program requirements for State 

agencies and institutions (95-024). 

Statement of Need: 

In recent years, State and Federal 

program reviews have found numerous 

cases of mismanagement, abuse, and, in 

some instances, fraud by child care 

institutions and facilities in the CACFP. 

These reviews revealed weaknesses in 

management controls over program 

operations and examples of regulatory 

noncompliance by institutions, 

including failure to pay facilities or 

failure to pay them in a timely manner; 

improper use of program funds for nonprogram expenditures; and improper 

meal reimbursements due to incorrect 

meal counts or to mis-characterized or 

incomplete income eligibility 

statements. In addition, audits and 

investigations conducted by the Office 

of Inspector General (OIG) have raised 

serious concerns regarding the 

adequacy of financial and 

administrative controls in CACFP. 

Based on its findings, the OIG 

recommended changes to CACFP 

review requirements and management 

controls. 

Summary of Legal Basis: 

Some of the changes proposed in the 

rule are discretionary changes being 

made in response to deficiencies found 

in program reviews and OIG audits. 

Other changes codify statutory changes 

made by the Healthy Meals for Healthy 

Americans Act of 1994 (Pub. L. 103- 

448), the Personal Responsibility and 

Work Opportunities Reconciliation Act 

of 1996 (Pub. L. 104-193), and the 

William F. Goodling Child Nutrition 

Reauthorization Act of 1998 (Pub. L. 

105-336). 

Alternatives: 

This proposed interim final rule is 

under development and alternatives are 

not yet articulated. FNS is working 

with State agencies to identify 

reasonable alternatives to implement 

the changes mandated by law. FNS will 

be developing extensive guidance 

materials in conjunction with agency 


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cooperators to meet the objectives of 

the statute. 

Anticipated Cost and Benefits: 

This rule contains changes designed to 

improve management and financial 

integrity in the CACFP. When 

implemented, these changes would 

affect all entities in CACFP, from USDA 

to participating children and children’s 

households. These changes will 

primarily affect the procedures used by 

State agencies in reviewing applications 

submitted by, and monitoring the 

performance of, institutions which are 

participating or wish to participate in 

the CACFP. Those changes which 

would affect institutions and facilities 

will not, in the aggregate, have a 

significant economic impact. 

Data on CACFP integrity is limited, 

despite numerous OIG reports on 

individual institutions and facilities 

that have been deficient in CACFP 

management. While program reviews 

and OIG reports clearly illustrate that 

there are weaknesses in parts of the 

program regulations and that there have 

been weaknesses in oversight, neither 

program reviews, OIG reports, nor any 

other data sources illustrate the 

prevalence and magnitude of CACFP 

fraud and abuse. This lack of 

information precludes USDA from 

estimating the amount of money lost 

due to fraud and abuse or the reduction 

in fraud and abuse the changes in this 

rule will realize. 

Risks: 

With the interim final rule in place and 

operational, risk of integrity problems 

is reduced. The final rule will use 

comments from stakeholders to further 

improve the rule. 

Timetable: 

Action Date FR Cite 

NPRM 09/12/00 65 FR 55103 

NPRM Comment 

Period End 

12/11/00 

Interim Final Rule 06/27/02 67 FR 43448 

Interim Final Rule 

Effective 

07/29/02 

Interim Final Rule 

Comment Period 

End 

12/24/02 

Interim Final Rule 09/01/04 69 FR 53502 

Interim Final Rule 

Effective 

10/01/04 

Interim Final Rule 

Comment Period 

End 

09/01/05 

Final Action 02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Local, State 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Agency Contact: 

James F. Herbert 

Regulatory Review Specialist 

Department of Agriculture 

Food and Nutrition Service 

10th Floor 

3101 Park Center Drive 

Alexandria, VA 22302 

Phone: 703 305–2572 

Email: james.herbert@fns.usda.gov 

Related RIN: Merged with 0584–AC94 

RIN: 0584–AC24 

USDA—FNS 

14. DIRECT CERTIFICATION OF 

CHILDREN IN FOOD STAMP 

HOUSEHOLDS AND CERTIFICATION 

OF HOMELESS, MIGRANT, AND 

RUNAWAY CHILDREN FOR FREE 

MEALS IN THE NSLP, SBP, AND SMP 

Priority: 

Other Significant 

Legal Authority: 

PL 108–265, sec 104 

CFR Citation: 

7 CFR 210; 7 CFR 215; 7 CFR 220; 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 McKinneyVento Homeless Assistance Act; (2) a 

runaway served by grant programs 

under the Runaway and Homeless 

Youth Act; or (3) migratory as defined 

in section 1309(2) of the Elementary 

and Secondary Education Act. The rule 

also requires phase-in of mandatory 

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. 

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 02/00/11 

Interim Final Rule 

Comment Period 

End 

05/00/11 

Final Action 10/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Local, State 

Agency Contact: 

James F. Herbert 

Regulatory Review Specialist 

Department of Agriculture 

Food and Nutrition Service 

10th Floor 

3101 Park Center Drive 

Alexandria, VA 22302 

Phone: 703 305–2572 

Email: james.herbert@fns.usda.gov 

Related RIN: Merged with 0584–AD62 

RIN: 0584–AD60 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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USDA—FNS 

15. SPECIAL SUPPLEMENTAL 

NUTRITION PROGRAM FOR WOMEN, 

INFANTS, AND CHILDREN (WIC): 

REVISIONS IN THE WIC FOOD 

PACKAGES 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

42 USC 1786 

CFR Citation: 

7 CFR 246 

Legal Deadline: 

Final, Statutory, November 2006. 

CN and WIC Reauthorization Act of 

2004 (Pub. L. 108-265) requires 

issuance of a final rule within 18 

months of release of IOM Report. 

Abstract: 

This final rule will affirm and address 

comments from stakeholders on the 

interim final rule that went into effect 

October 1, 2009, and for which the 

comment period ended February 1, 

2010. Significant changes to the rule 

are not anticipated. The rule amended 

regulations governing the WIC food 

packages to align them more closely 

with updated nutrition science and the 

infant feeding practice guidelines of the 

American Academy of Pediatrics, 

promote and support more effectively 

the establishment of successful longterm breastfeeding, provide WIC 

participants with a wider variety of 

food, and provide WIC State agencies 

with greater flexibility in prescribing 

food packages to accommodate 

participants with cultural food 

preferences. The final rule considers 

public comments submitted on the 

impacts of the changes and how they 

might be refined to assist State agencies 

and recipients. 

Statement of Need: 

As the population served by WIC has 

grown and become more diverse over 

the past 20 years, the nutritional risks 

faced by participants have changed, 

and though nutrition science has 

advanced, the WIC supplemental food 

packages have remained largely 

unchanged. A rule is needed to 

implement recommended changes to 

the WIC food packages based on the 

current nutritional needs of WIC 

participants and advances in nutrition 

science. 

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 developed a regulatory impact 

analysis that addressed a variety of 

alternatives that were considered in the 

interim final rulemaking. The 

regulatory impact analysis was 

published as an appendix to the 

interim rule. FNS developed a 

regulatory impact analysis that 

addressed a variety of alternatives that 

were considered in the interim final 

rulemaking. That regulatory impact 

analysis was published as an appendix 

to the interim rule. 

Anticipated Cost and Benefits: 

The regulatory impact analysis for this 

rule provided a reasonable estimate of 

the anticipated effects of the rule. This 

analysis estimated that the provisions 

of the rule would have a minimal 

impact on the costs of overall 

operations of the WIC Program over 5 

years. The regulatory impact analysis 

was published as an appendix to the 

interim rule. 

Risks: 

This rule applies to WIC State agencies 

with respect to their selection of foods 

to be included on their food lists. As 

a result, vendors will be indirectly 

affected and the food industry will 

realize increased sales of some foods 

and decreases in other foods, with an 

overall neutral effect on sales 

nationally. The rule may have an 

indirect economic affect on certain 

small businesses because they may 

have to carry a larger variety of certain 

foods to be eligible for authorization as 

a WIC vendor. With the high degree 

of State flexibility allowable under this 

final rule, small vendors will be 

impacted differently in each State 

depending upon how that State chooses 

to meet the new requirements. It is, 

therefore, not feasible to accurately 

estimate the rule’s impact on small 

vendors. Since neither FNS nor the 

State agencies regulate food producers 

under the WIC Program, it is not 

known how many small entities within 

that industry may be indirectly affected 

by the rule. FNS has, however, 

modified the new food provision in an 

effort to mitigate the impact on small 

entities. This rule adds new food items, 

such as fruits and vegetables and whole 

grain breads, which may require some 

WIC vendors, particularly smaller 

stores, to expand the types and 

quantities of food items stocked in 

order to maintain their WIC 

authorization. In addition, vendors also 

have to make available more than one 

food type from each WIC food category, 

except for the categories of peanut 

butter and eggs, which may be a change 

for some vendors. To mitigate the 

impact of the fruit and vegetable 

requirement, the rule allows canned, 

frozen, and dried fruits and vegetables 

to be substituted for fresh produce. 

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 08/07/06 71 FR 44784 

NPRM Comment 

Period End 

11/06/06 

Interim Final Rule 12/06/07 72 FR 68966 

Interim Final Rule 

Effective 

02/04/08 

Interim Final Rule 

Comment Period 

End 

02/01/10 

Final Action 06/00/11 

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 

URL For Public Comments: 

www.fns.usda.gov/wic 

Agency Contact: 

James F. Herbert 

Regulatory Review Specialist 

Department of Agriculture 

Food and Nutrition Service 

10th Floor 

3101 Park Center Drive 

Alexandria, VA 22302 

Phone: 703 305–2572 

Email: james.herbert@fns.usda.gov 

RIN: 0584–AD77 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79485 

USDA—Food Safety and Inspection 

Service (FSIS) 

PROPOSED RULE STAGE 

16. 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 (SOPs). FSIS 

also is proposing pathogen reduction 

performance standards that would be 

applicable to egg products and 

pasteurized shell eggs. 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 for shell 

egg packers that will provide 

information intended to help them 

safely process shell eggs intended for 

human consumption or further 

processing. 

Statement of Need: 

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 costbenefit 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 

on the 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. 

Egg product inspection systems of 

foreign countries wishing to export 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 80 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 alternative. 

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. 

The preliminary anticipated annualized 

costs of the proposed action are 

approximately $7 million. The 

preliminary anticipated benefits of the 

proposed action are approximately $90 

million per year. 

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 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79486 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

public, an intra-Agency group of 

scientific and technical experts is 

conducting a risk management analysis. 

The group has been charged with 

identifying the lethality requirement 

sufficient to ensure the safety of egg 

products and the alternative methods 

for implementing the requirement. FSIS 

has developed new risk assessments for 

Salmonella Enteritidis in eggs and for 

Salmonella spp. in liquid egg products 

to evaluate the risk associated with the 

regulatory alternatives. 

Timetable: 

Action Date FR Cite 

NPRM 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses, Governmental Jurisdictions 

Government Levels Affected: 

None 

Agency Contact: 

Victoria Levine 

Program Analyst, Policy Issuances 

Division 

Department of Agriculture 

Food Safety and Inspection Service 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 720–5627 

Fax: 202 690–0486 

Email: victoria.levine@fsis.usda.gov 

RIN: 0583–AC58 

USDA—FSIS 

17. NEW POULTRY SLAUGHTER 

INSPECTION 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

21 USC 451 et seq 

CFR Citation: 

9 CFR 381.66; 9 CFR 381.67; 9 CFR 

381.76; 9 CFR 381.83; 9 CFR 381.91; 

9 CFR 381.94 

Legal Deadline: 

None 

Abstract: 

FSIS is proposing a new inspection 

system for young poultry slaughter 

establishments that would facilitate 

public health-based inspection. This 

new system would be available initially 

only to young chicken slaughter 

establishments. Establishments that 

slaughter broilers, fryers, roasters, and 

Cornish game hens (as defined in 9 

CFR 381.170) would be considered as 

‘‘young chicken establishments.’’ FSIS 

is also proposing to revoke the 

provisions that allow young chicken 

slaughter establishments to operate 

under the current Streamlined 

Inspection System (SIS) or the New 

Line Speed (NELS) Inspection System. 

The proposed rule would establish new 

performance standards to reduce 

pathogens. FSIS anticipates that this 

proposed rule would provide the 

framework for action to provide public 

health-based inspection in all 

establishments that slaughter amenable 

poultry species. 

Under the proposed new system, young 

chicken slaughter establishments would 

be required to sort chicken carcasses 

and to conduct other activities to 

ensure that carcasses are not 

adulterated before they enter the 

chilling tank. 

Statement of Need: 

Because of the risk to the public health 

associated with pathogens on young 

chicken carcasses, FSIS is proposing a 

new inspection system that would 

allow for more effective inspection of 

young chicken carcasses, would allow 

the Agency to more effectively allocate 

its resources, would encourage industry 

to more readily use new technology, 

and would include new performance 

standards to reduce pathogens. 

This proposed rule is an example of 

regulatory reform because it would 

facilitate technological innovation in 

young chicken slaughter 

establishments. It would likely result in 

more cost-effective dressing of young 

chickens that are ready to cook or ready 

for further processing. Similarly, it 

would likely result in more efficient 

and effective use of Agency resources. 

Summary of Legal Basis: 

The Secretary of Agriculture is charged 

by the Poultry Products Inspection Act 

(PPIA—21 U.S.C. 451 et seq.) with 

carrying out a mandatory poultry 

products inspection program. The Act 

requires post-mortem inspection of all 

carcasses of slaughtered poultry subject 

to the Act and such reinspection as 

deemed necessary (21 U.S.C. 455(b)). 

The Secretary is authorized to 

promulgate such rules and regulations 

as are necessary to carry out the 

provisions of the Act (21 U.S.C. 463(b)). 

The Agency has tentatively determined 

that this rule would facilitate FSIS 

post-mortem inspection of young 

chicken carcasses. The proposed new 

system would likely result in more 

efficient and effective use of Agency 

resources and in industry innovations. 

Alternatives: 

FSIS considered the following options 

in developing this proposal: 

1) No action. 

2) Propose to implement HACCP-Based 

Inspection Models Pilot in regulations. 

3) Propose to establish a mandatory, 

rather than a voluntary, new inspection 

system for young chicken slaughter 

establishments. 

4) Propose standards of identity 

regulations for young chickens that 

include trim and processing defect 

criteria and that take into account the 

intended use of the product. 

5) Propose a voluntary new inspection 

system for young chicken slaughter 

establishments and propose standards 

of identity for whole chickens, 

regardless of the products’ intended 

use. 

Anticipated Cost and Benefits: 

The proposed performance standards 

and the implementation of public 

health-based inspection would likely 

improve the public health. FSIS is 

conducting a risk assessment for this 

proposed rule to assess the likely 

public health benefits that the 

implementation of this rule may 

achieve. 

Establishments that volunteer for this 

proposed new inspection system 

alternative would likely need to make 

capital investments in facilities and 

equipment. They may also need to add 

labor (trained employees). However, 

one of the beneficial effects of these 

investments would likely be the 

lowering of the average cost per pound 

to dress poultry properly. Cost savings 

would likely result because of 

increased line speeds, increased 

productivity, and increased flexibility 

to industry. The expected lower average 

unit cost for dressing poultry would 

likely give a marketing advantage to 

establishments under the new system. 

Consumers would likely benefit from 

lower retail prices for high quality 

poultry products. The rule would also 

likely provide opportunities for the 

industry to innovate because of the 

increased flexibility it would allow 

poultry slaughter establishments. In 

addition, in the public sector, benefits 

would accrue to FSIS from the more 

effective deployment of FSIS inspection 

program personnel to verify process 


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control based on risk factors at each 

establishment. 

Risks: 

Salmonella and other pathogens are 

present on a substantial portion of 

poultry carcasses inspected by FSIS. 

Foodborne Salmonella cause a large 

number of human illnesses that at 

times lead to hospitalization and even 

death. There is an apparent relationship 

between human illness and prevalence 

levels for salmonella in young chicken 

carcasses. FSIS believes that through 

better allocation of inspection resources 

and the use of performance standards, 

it would be able to reduce the 

prevalence of salmonella and other 

pathogens in young chickens. 

Timetable: 

Action Date FR Cite 

NPRM 10/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Dr. Daniel L. Engeljohn 

Deputy Assistant Administrator, Office of 

Policy and Program Development 

Department of Agriculture 

Food Safety and Inspection Service 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 205–0495 

Fax: 202 401–1760 

Email: daniel.engeljohn@fsis.usda.gov 

RIN: 0583–AD32 

USDA—FSIS 

18. MANDATORY INSPECTION OF 

CATFISH AND CATFISH PRODUCTS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

21 USC 601 et seq; PL 110–249, sec 

11016 

CFR Citation: 

9 CFR ch III, subchapter F (new) 

Legal Deadline: 

Final, Statutory, December 2009, Final 

regulations NLT 18 months after 

enactment of PL 110–246. 

Abstract: 

The Food, Conservation, and Energy 

Act of 2008 (Pub. L. 110-246, sec. 

11016), known as the 2008 Farm Bill, 

amended the Federal Meat Inspection 

Act (FMIA) to make catfish an 

amenable species under the FMIA. 

Amenable species must be inspected, 

so this rule will define inspection 

requirements for catfish. The 

regulations will define ‘‘catfish’’ and 

the scope of coverage of the regulations 

to apply to establishments that process 

farm-raised species of catfish and to 

catfish and catfish products. The 

regulations will take into account the 

conditions under which the catfish are 

raised and transported to a processing 

establishment. 

Statement of Need: 

The Food, Conservation, and Energy 

Act of 2008 (Pub. L. 110-246, sec. 

11016), known as the 2008 Farm Bill, 

amended the Federal Meat Inspection 

Act (FMIA) to make catfish an 

amenable species under the FMIA. The 

Farm Bill directs the Department to 

issue final regulations implementing 

the FMIA amendments not later than 

18 months after the enactment date 

(June 18, 2008) of the legislation. 

Summary of Legal Basis: 

21 U.S.C. 601 to 695 and Public Law 

110-246, section 11016 

Alternatives: 

The option of no rulemaking is 

unavailable. The Agency has 

considered alternative methods of 

implementation and levels of 

stringency, and the effects on foreign 

and domestic commerce and on small 

business associated with the 

alternatives. 

Anticipated Cost and Benefits: 

FSIS anticipates benefits from uniform 

standards and the more extensive and 

intensive inspection service that FSIS 

provides (compared with current 

voluntary inspection programs). FSIS 

would apply requirements for imported 

catfish that would be equivalent to 

those applying to catfish raised and 

processed in the United States. 

Risks: 

In preparing regulations on catfish and 

catfish products, the Agency will 

consider any risks to public health or 

other pertinent risks associated with 

the production, processing, and 

distribution of the products. FSIS will 

determine, through scientific risk 

assessment procedures, the magnitude 

of the risks associated with catfish and 

how they compare with those 

associated with other foods in FSIS’s 

jurisdiction. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Quita Bowman Blackwell 

Acting Assistant Administrator, Office of 

Catfish Inspection Program 

Department of Agriculture 

Food Safety and Inspection Service 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 720–5735 

Fax: 202 690–1742 

RIN: 0583–AD36 

USDA—FSIS 

19. ELECTRONIC IMPORTED 

PRODUCT INSPECTION 

APPLICATIONS; ELECTRONIC 

FOREIGN IMPORTED PRODUCT AND 

FOREIGN ESTABLISHMENT 

CERTIFICATIONS; DELETION OF 

STREAMLINED INSPECTION 

PROCEDURES FOR CANADIAN 

PRODUCT 

Priority: 

Other Significant 

Legal Authority: 

Federal Meat Inspection Act (FMIA) (21 

USC 601 to 695), the Poultry Products 

Inspection Act (PPIA) (21 USC 451 to 

470); Egg Products Inspection Act 

(EPIA) (21 USC 1031 to 1056) 

CFR Citation: 

9 CFR 304.3; 9 CFR 327.2 and 327.4; 

9 CFR 381.196 to 381.198; 9 CFR 

590.915 and 590.920 

Legal Deadline: 

None 

Abstract: 

FSIS is proposing to amend the meat, 

poultry, and egg products import 

inspection regulations to provide for an 

electronic application, and electronic 

imported product and foreign 

establishment certification system. FSIS 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79488 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

is also proposing to delete the 

‘‘streamlined’’ import inspection 

procedures for Canadian product. In 

addition, the Agency is proposing that 

official import inspection establishment 

must develop, implement, and maintain 

written Sanitation SOPs, as provided in 

9 CFR 416.11 through 416.17. 

Statement of Need: 

FSIS is proposing these regulations to 

provide for the electronic import 

system, which will be available through 

the Agency’s Public Health Information 

System (PHIS), a computerized, Webbased inspection information system. 

The import system will enable 

applicants to electronically submit and 

track import inspection applications 

that are required for all commercial 

entries of FSIS regulated products 

imported in to the U.S. FSIS inspection 

program personnel will be able to 

access the PHIS system to assign 

appropriate imported product 

inspection activities. The electronic 

import system will also facilitate the 

foreign imported product and annual 

foreign establishment certifications by 

providing immediate and direct 

electronic government-to-government 

exchange of information. The Agency 

is proposing to delete the Canadian 

streamlined import inspection 

procedures because they have not been 

in use since 1990 and are obsolete. 

Sanitation SOPs are written procedures 

establishments develop, implement, 

and maintain to prevent direct 

contamination or adulteration of meat 

or poultry products. To ensure that 

imported meat and poultry products do 

not become contaminated while 

undergoing reinspection prior to 

entering the U.S., FSIS is proposing to 

clarify that official import inspection 

establishments must develop written 

Sanitation SOPs. 

Summary of Legal Basis: 

The authorities for this proposed rule 

are: the Federal Meat Inspection Act 

(FMIA) (21 U.S.C. 601 to 695), the 

Poultry Products Inspection Act (PPIA) 

(21 U.S.C. 451 to 470), Egg Products 

Inspection Act (EPIA)(21 U.S.C. 1031 to 

1056) and the regulations that 

implement these Acts. 

Alternatives: 

The use of the electronic import system 

is voluntary. The Agency will continue 

to accept and process paper import 

inspection applications, and foreign 

establishment and foreign imported 

product certificates. The Canadian 

streamlined import inspection 

procedures are not currently in use. 

Proposing Sanitation SOPs in official 

import inspection establishments will 

prevent direct contamination or 

adulteration of product. Therefore, no 

alternatives were considered. 

Anticipated Cost and Benefits: 

Under this proposed rule, the industry 

will have the option of filing inspection 

applications electronically and 

submitting electronic foreign product 

and establishment certificates through 

the PHIS. Since the electronic option 

is voluntary; applicants and the foreign 

countries that choose to file 

electronically will do so only if the 

benefits outweigh the cost. Sanitation 

(SOPs) are a condition of approval for 

official import inspection 

establishments, and as a requirement 

for official import inspection 

establishments to continue to operate 

under Federal inspection. The proposed 

rule will clarify that official import 

inspection establishments must have 

developed written Sanitation SOPs 

before being granted approval and that 

existing official import inspection 

establishments must meet Sanitation 

SOP requirements. Since, in practice, 

FSIS has always expected official 

import inspection establishments to 

maintain Sanitation SOPs during the 

reinspection of imported products, the 

proposed amendment for these 

sanitation requirements will have little, 

if any, cost impact on the industry. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Mary Stanley 

Director, International Policy Division 

Office of Policy and Program 

Department of Agriculture 

Food Safety and Inspection Service 

Room 2125 

1400 Independence Avenue SW. 

Washington, DC 20250 

Phone: 202 720–0287 

RIN: 0583–AD39 

USDA—FSIS 

20. ELECTRONIC EXPORT 

APPLICATION AND CERTIFICATION 

AS A REIMBURSABLE SERVICE AND 

FLEXIBILITY IN THE REQUIREMENTS 

FOR OFFICIAL EXPORT INSPECTION 

MARKS, DEVICES, AND 

CERTIFICATES 

Priority: 

Other Significant 

Legal Authority: 

Federal Meat Inspection Act (FMIA) (21 

USC 601 to 695); Poultry Products 

Inspection Act (PPIA) (21 USC 451 to 

470); Egg Products Inspection Act 

(EPIA) (21 USC 1031 to 1056) 

CFR Citation: 

9 CFR 312.8; 9 CFR 322.1 and 322.2; 

9 CFR 350.7; 9 CFR 362.5; 9 CFR 

381.104 to 381.106; 9 CFR 590.407; 9 

CFR 592.20 and 592.500 

Legal Deadline: 

None 

Abstract: 

The Food Safety and Inspection Service 

(FSIS) is proposing to amend the meat, 

poultry, and egg product inspection 

regulations to provide an electronic 

export application and certification 

process. FSIS is proposing to charge 

users for the use of the proposed 

system. FSIS is also proposing to 

provide establishments that export 

meat, poultry, and egg products with 

flexibility in the official export 

inspection marks, devices, and 

certificates. In addition, FSIS is 

proposing egg product export 

regulations that parallel the meat and 

poultry export regulations. 

Statement of Need: 

FSIS is proposing these regulations to 

facilitate the electronic processing of 

export applications and certificates 

through the Public Health Information 

System (PHIS), a computerized, Webbased inspection information system. 

The current export application and 


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certification regulations provide only 

for a paper-based process. This 

proposed rule will provide this 

electronic export system as a 

reimbursable certification service 

charged to the exporter. 

Summary of Legal Basis: 

The authorities for this proposed rule 

are: The Federal Meat Inspection Act 

(FMIA) (21 U.S.C. 601 to 695), the 

Poultry Products Inspection Act (PPIA) 

(21 U.S.C. 451 to 470), the Egg Products 

Inspection Act (EPIA) (21 U.S.C. 1031 

to 1056), and the regulations that 

implement these Acts. FSIS is 

proposing to charge for the electronic 

export application and certification 

system under the Agricultural 

Marketing Act (7 U.S.C. 1622(h)) that 

provides the Secretary of Agriculture 

with the authority to: ‘‘Inspect, certify, 

and identify the class, quality, quantity, 

and condition of agricultural products 

when shipped or received in interstate 

commerce, under such rules and 

regulations as the Secretary of 

Agriculture may prescribe, including 

assessment and collection of such fees 

as will be reasonable and as nearly as 

may be to cover the cost of the service 

rendered, to the end that agricultural 

products may be marketed to the best 

advantage, that trading may be 

facilitated, and that consumers may be 

able to obtain the quality product 

which they desire.‘‘ 

Alternatives: 

The electronic export applications and 

certification system is being proposed 

as a voluntary service, therefore, 

exporters have the option of continuing 

to use the current paper-based system. 

Therefore, no alternatives were 

considered. 

Anticipated Cost and Benefits: 

FSIS is proposing to charge exporters 

that choose to utilize the system $90.00 

per application submitted. Automating 

the export application and certification 

process will facilitate the exportation of 

U.S. meat, poultry, and egg products 

by streamlining and automating the 

processes that are in use while ensuring 

that foreign regulatory requirements are 

met. The direct cost to exporters would 

be approximately $22.5 million to $31.5 

million per year, if they choose to file 

electronically. However, the total cost 

to an exporter would depend on the 

number of electronic applications 

processed. An exporter that processes 

only a few applications per year would 

not be likely to experience a significant 

economic impact. Under this proposal, 

inspection personnel workload is 

reduced through the elimination of the 

physical handling and processing of 

applications and certificates. When an 

electronic government-to-government 

system interface or data exchange is 

used, fraudulent transactions, such as 

false alterations and reproductions, will 

be significantly reduced, if not 

eliminated. The electronic export 

system is designed to ensure 

authenticity, integrity, and 

confidentiality. Exporters will be 

provided a more efficient and effective 

application and certification process. 

The proposed egg product export 

regulations provide the same export 

requirements across all products 

regulated by FSIS and consistency in 

the export application and certification 

process. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Dr. Ron Jones 

Assistant Administrator, Office of 

International Affairs 

Department of Agriculture 

Food Safety and Inspection Service 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 720–3473 

RIN: 0583–AD41 

USDA—FSIS 

FINAL RULE STAGE 

21. PERFORMANCE STANDARDS FOR 

THE PRODUCTION OF PROCESSED 

MEAT AND POULTRY PRODUCTS; 

CONTROL OF LISTERIA 

MONOCYTOGENES IN 

READY–TO–EAT 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, and measures, including 

testing, to control Listeria 

monocytogenes in RTE 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, sciencebased 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: 

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 are necessary to help ensure 


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the safety of these products; give 

establishments the incentive and 

flexibility to adopt innovative, sciencebased food safety processing procedures 

and controls; and provide objective, 

measurable standards that can be 

verified by Agency oversight. 

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 endproduct testing and requiring ‘‘use-by’’ 

date labeling on ready-to-eat products. 

Anticipated Cost and Benefits: 

Benefits are expected to result from 

fewer 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. FSIS currently estimates net 

benefits from the 2003 interim final 

rule at $470 to $575 million, with 

annual recurring costs at $150.4 

million, if FSIS discounts the capital 

cost at 7 percent. FSIS is continuing 

to analyze the potential impact of the 

other provisions of the proposal. 

The other main provisions of the 

proposed rule are: Lethality 

performance standards for Salmonella 

and E. coli O157: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. 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. Consequently, there will be 

fewer cases of foodborne illness. 

Risks: 

Before FSIS published the proposed 

rule, FDA and FSIS had estimated that 

each year L. monocytogenes caused 

2,540 cases of foodborne illness, 

including 500 fatalities. The Agencies 

estimated that about 65.3 percent of 

these cases, or 1660 cases and 322 

deaths per year, were attributable to 

RTE meat and poultry products. The 

analysis of the interim final rule on 

control of L. monocytogenes 

conservatively estimated that 

implementation of the rule would lead 

to an annual reduction of 27.3 deaths 

and 136.7 illnesses at the median. FSIS 

is continuing to analyze data on 

production volume and Listeria 

controls in the RTE meat and poultry 

products industry and is using the FSIS 

risk assessment model for L. 

monocytogenes to determine the likely 

risk reduction effects of the rule. 

Preliminary results indicate that the 

risk reductions being achieved are 

substantially greater than those 

estimated in the analysis of the interim 

rule. 

FSIS is also analyzing the potential risk 

reductions that might be achieved by 

implementing the lethality and 

stabilization performance standards for 

products that would be subject to the 

proposed rule. The risk reductions to 

be achieved by the proposed rule and 

that are being achieved by the interim 

rule are intended to contribute to the 

Agency’s public health protection 

effort. 

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 

Affirmation of Interim 

Final Rule 

03/00/11 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Dr. Daniel L. Engeljohn 

Deputy Assistant Administrator, Office of 

Policy and Program Development 

Department of Agriculture 

Food Safety and Inspection Service 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 205–0495 

Fax: 202 401–1760 

Email: daniel.engeljohn@fsis.usda.gov 

RIN: 0583–AC46 

USDA—FSIS 

22. 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 


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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 

retailer, the Agency did not find 

significant participation in the 

voluntary nutrition labeling program for 

single-ingredient, raw meat and poultry 

products. Ground or chopped products 

are similar to multi-ingredient 

products. This rule is necessary so that 

consumers can have the information 

they need to construct healthy diets. 

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: 

Cost 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 consumers modify 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 supplemental 

proposed rule. FSIS estimates that the 

annualized benefits of the proposed 

rule will range from approximately 

$185.6 to $230.8 million, using a 7 

percent discount rate over 20 years. 

FSIS estimates that the annualized 

costs will range from approximately 

$26.7 to $44.8 million, using a 7 

percent discount rate over 20 years. 

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 

Supplemental 

Proposed Rule 

12/18/09 74 FR 67736 

Supplemental 

Proposed Rule 

Comment Period 

End 

02/16/10 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Rosalyn Murphy–Jenkins 

Director, Labeling and Program Delivery 

Division 

Department of Agriculture 

Food Safety and Inspection Service 

5601 Sunnyside Avenue 

Beltsville, MD 20705–5000 

Phone: 301 504–0878 

Fax: 301 504–0872 

Email: rosalyn.murphyjenkins@fsis.usda.gov 

RIN: 0583–AC60 

USDA—FSIS 

23. NOTIFICATION, DOCUMENTATION, 

AND RECORDKEEPING 

REQUIREMENTS FOR INSPECTED 

ESTABLISHMENTS 

Priority: 

Other Significant 

Legal Authority: 

21 USC 612 to 613; 21 USC 459 

CFR Citation: 

9 CFR 417.4; 9 CFR 418 

Legal Deadline: 

None 

Abstract: 

The Food Safety and Inspection Service 

(FSIS) has proposed to require 

establishments subject to inspection 

under the Federal Meat Inspection Act 

and the Poultry Products Inspection 

Act to promptly notify the Secretary of 

Agriculture that an adulterated or 

misbranded product received by or 

originating from the establishment has 

entered into commerce, if the 

establishment believes or has reason to 

believe that this has happened. FSIS 

has also proposed to require these 

establishments to: (1) Prepare and 

maintain current procedures for the 

recall of all products produced and 

shipped by the establishment and (2) 

document each reassessment of the 

process control plans of the 

establishment. 

Statement of Need: 

The Food, Conservation, and Energy 

Act of 2008 (Pub. L. 110-246, sec. 

11017), known as the 2008 Farm Bill, 

amended the Federal Meat Inspection 

Act (FMIA) and the Poultry Products 

Inspection Act (PPIA) to require 

establishments subject to inspection 

under these Acts to promptly notify the 

Secretary that an adulterated or 

misbranded product received by or 

originating from the establishment has 

entered into commerce, if the 

establishment believes or has reason to 

believe that this has happened. Section 

11017 also requires establishments 

subject to inspection under the FMIA 

and PPIA to: (1) Prepare and maintain 

current procedures for the recall of all 

products produced and shipped by the 

establishment; and (2) document each 

reassessment of the process control 

plans of the establishment. 

Summary of Legal Basis: 

21 U.S.C. 612 and 613; 21 U.S.C. 459, 

and Public Law 110-246, sec. 11017. 

Alternatives: 

The option of no rulemaking is 

unavailable. 

Anticipated Cost and Benefits: 

Approximate costs: $5.0 million for 

labor and costs; $5.2 million for first 

year costs; $0.7 million average costs 

adjusted with a 3.0 percent inflation 

rate for following years. Total 

approximate costs: $10.2 million. The 

average cost of this final rule to small 

entities is expected to be less than one 

tenth of one cent of meat and poultry 

food products per annum. Therefore, 

FSIS has determined that this rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Approximate benefits: Benefits have not 

been monetized because quantified data 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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on benefits attributable to this final rule 

are not available. Non-monetary 

benefits include improved protection of 

the public health, improved HACCP 

plans, and improved recall 

effectiveness. 

Risks: 

In preparing regulations on the 

shipment of adulterated meat and 

poultry products by meat and poultry 

establishments, the preparation and 

maintenance of procedures for recalled 

products produced and shipped by 

establishments, and the documentation 

of each reassessment of the process 

control plans by the establishment, the 

Agency considered any risks to public 

health or other pertinent risks 

associated with these actions. 

Timetable: 

Action Date FR Cite 

NPRM 03/25/10 75 FR 14361 

NPRM Comment 

Period End 

05/24/10 

Final Action 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Victoria Levine 

Program Analyst, Policy Issuances 

Division 

Department of Agriculture 

Food Safety and Inspection Service 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 720–5627 

Fax: 202 690–0486 

Email: victoria.levine@fsis.usda.gov 

RIN: 0583–AD34 

USDA—FSIS 

24. FEDERAL–STATE INTERSTATE 

SHIPMENT COOPERATIVE 

INSPECTION PROGRAM 

Priority: 

Other Significant 

Legal Authority: 

PL 110–246, sec 11015 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

Final, Statutory, December 18, 2009. 

Abstract: 

FSIS has proposed regulations to 

implement a new voluntary FederalState cooperative inspection program 

under which State-inspected 

establishments with 25 or fewer 

employees would be eligible to ship 

meat and poultry products in interstate 

commerce. State-inspected 

establishments selected to participate in 

this program would be required to 

comply with all Federal standards 

under the Federal Meat Inspection Act 

(FMIA) and the Poultry Products 

Inspection Act (PPIA). These 

establishments would receive 

inspection services from State 

inspection personnel that have been 

trained and certified to assist with 

enforcement of the FMIA and PPIA. 

Meat and poultry products produced 

under the program that have been 

inspected and passed by selected Stateinspection personnel would bear a 

Federal mark of inspection. FSIS is 

proposing these regulations in response 

to the Food, Conservation, and Energy 

Act, enacted on June 18, 2008 (the 2008 

Farm Bill). Section 11015 of 2008 Farm 

Bill provides for the interstate shipment 

of State-inspected meat and poultry 

product from selected establishments 

and requires that FSIS promulgate 

implementing regulations no later than 

18 months from the date of its 

enactment. 

Statement of Need: 

This action is needed to implement a 

new Federal-State cooperative program 

that will permit certain State-inspected 

establishments to ship meat and 

poultry products in interstate 

commerce. Inspection services for 

establishments selected to participate in 

the program will be provided by State 

inspection personnel that have been 

trained and certified in the 

administration and enforcement of the 

Federal Meat Inspection Act (FMIA) (21 

U.S.C. 601 et seq.) and the Poultry 

Products Inspection Act (PPIA) (21 

U.S.C. 451 et seq.) Meat and poultry 

products produced by establishments 

selected to participate in the program 

will bear a Federal mark of inspection. 

Summary of Legal Basis: 

This action is authorized under section 

11015 of the Food, Conservation, and 

Energy Act of 2008 (the 2008 Farm Bill) 

(Pub. L. 110-246). Section 11015 

amends the Federal Meat Inspection 

Act (FMIA) (21 U.S.C. 601 et seq.) and 

the Poultry Products Inspection Act 

(PPIA) (21 U.S.C. 451 et seq.) to 

establish an optional Federal-State 

cooperative program under which 

State-inspected establishments would 

be permitted to ship meat and poultry 

products in interstate commerce. The 

law requires that FSIS promulgate 

implementing regulations no later than 

18 months after the date of enactment. 

Alternatives: 

1. No action: FSIS did not consider the 

alternative of no action because section 

11015 of the 2008 Farm Bill requires 

that it promulgate regulations to 

implement the new Federal-State 

cooperative program. The Agency did 

consider alternatives on how to 

implement the new program. 

2. Limit participation in the program 

to State-inspected establishments with 

25 or fewer employees on average: 

Under the law, State-inspected 

establishments that have 25 or fewer 

employees on average are permitted to 

participate in the program. The law 

also provides that FSIS may select 

establishments that employ more than 

25 but fewer than 35 employees on 

average as of June 18, 2008 (the date 

of enactment), to participate in the 

program. Under the law, if these 

establishments employ more than 25 

employees on average 3 years after FSIS 

promulgates implementing regulations, 

they are required to transition to a 

Federal establishment. FSIS rejected the 

option of limiting the program to 

establishment that employ 25 or fewer 

employees on average to give additional 

small establishments the opportunity to 

participate in the program and ship 

their meat and poultry products in 

interstate commerce. 

3. Permit establishments with 25 to 35 

employees on average as of June 18, 

2008, to participate in the program. 

FSIS chose the option of permitting 

these establishments to be selected to 

participate in the program to give 

additional small establishments the 

opportunity to ship their meat and 

poultry products in interstate 

commerce. Under this option, FSIS will 

develop a procedure to transition any 

establishment that employs more than 

25 people on average to a Federal 

establishment. Establishments that 

employee 24 to 35 employees on 

average as of June 18, 2008, would be 

subject to the transition procedure 

beginning on the date 3 years after the 

Agency promulgates implementing 

regulations. 

Anticipated Cost and Benefits: 

FSIS is analyzing the costs of this 

proposed rule to industry, FSIS, State 

and local governments, small entities, 

and foreign countries. Participation in 


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the new Federal-State cooperative 

program will be optional. Thus, the 

costs and benefits associated with the 

proposed rule will depend on the 

number of States and establishments 

that choose to participate. Very small 

and certain small establishments Stateinspected establishments that are 

selected to participate in the program 

are likely to benefit from the program 

because they will be permitted sell 

their products to consumers in other 

States and foreign countries. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 09/16/09 74 FR 47648 

NPRM Comment 

Period End 

12/16/09 

Final Action 05/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Federal, State 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Agency Contact: 

Rachel Edelstein 

Director, Policy Issuances Division 

Department of Agriculture 

Food Safety and Inspection Service 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 720–0399 

Fax: 202 690–0486 

Email: rachel.edelstein@fsis.usda.gov 

RIN: 0583–AD37 

USDA—Rural Business-Cooperative 

Service (RBS) 

FINAL RULE STAGE 

25. ∑ VALUE–ADDED PRODUCER 

GRANT PROGRAM 

Priority: 

Other Significant 

Legal Authority: 

PL 110–246 

CFR Citation: 

7 CFR 1951, subpart E; 7 CFR 4284, 

subpart J 

Legal Deadline: 

None 

Abstract: 

The Agency proposes to modify 7 CFR 

part 4284, subpart J, to include the 

definitions for mid-tier value chain and 

value-added agricultural product to 

include an agricultural commodity or 

product that is aggregated and marketed 

as a locally produced agricultural food 

product. Additionally, the proposed 

rule will expand the grant term not to 

exceed 3 years; implement a simplified 

application process for project 

proposals less than $50,000; provide for 

priority to projects that increase 

opportunities for beginning farmers or 

ranchers, socially disadvantaged 

farmers or ranchers, and operators of 

small- and medium sized farms and 

ranches that are structured as a family 

farm; and implement a reservation of 

funds for projects to benefit beginning 

farmers or ranchers, socially 

disadvantaged farmers or ranchers, and 

mid-tier value chains. 

The Agency is also proposing to amend 

7 CFR part 1951, subpart E, to allow 

the delegation of the servicing of the 

program to USDA State Office 

personnel. 

Statement of Need: 

The modifications to the Value Added 

Producer Grant program will streamline 

program regulations resulting in better 

quality applications. It is expected that 

all of the changes will result in time 

and resource savings to the applicant 

and the Agency. Publication of the final 

rule is crucial to program 

implementation. The program will 

directly create new businesses, assist 

with the expansion of existing 

businesses, create jobs, increase the 

flow of tax dollars to rural 

communities, and add lasting value in 

terms of rural community impact. 

Summary of Legal Basis: 

The program was authorized by the 

Agriculture Risk Protection Act of 2000, 

section 231 (Pub. L. 106-224). The 

purpose of the Value Added Producer 

Grant (VAPG) program is to help 

eligible independent producers of 

agricultural commodities, agricultural 

producer groups, farmer and rancher 

cooperatives, and majority-owned, 

producer-based business ventures 

develop business plans for viable 

marketing opportunities and develop 

strategies to create marketing 

opportunities. 

Alternatives: 

An alternative is to continue under the 

interim rule. The interim rule is 

scheduled to be published and remain 

in effect until a final rule is adopted. 

A notice announcing FY 2010 funding 

will be published after the interim rule. 

FY 2010 funding will be expendable in 

FY 2011. 

Anticipated Cost and Benefits: 

Costs: 

The anticipated costs associated with 

this process are contract services. An 

exact dollar amount cannot be 

determined at this time, but it will not 

have an annual effect on the economy 

of $100 million or more. 

No change in FTE needs is anticipated. 

Minimal automation changes are 

anticipated. 

Benefits: 

The intended action is to fine tune the 

program regulations, making them 

easier to use for the public and Agency 

staff, while incorporate changes 

designed to reduce the cost to the 

Government and the subsidy rate. 

Risks: 

Program risks include risk of loss in 

the loans guaranteed under this 

program. We anticipate mitigating these 

risks with improved regulatory and 

administrative guidance and 

appropriate training. 

Timetable: 

Action Date FR Cite 

NPRM 05/28/10 75 FR 29920 

NPRM Comment 

Period End 

06/28/10 

Interim Final Rule 12/00/10 

Interim Final Rule 

Effective 

01/00/11 

Interim Final Rule 

Comment Period 

End 

02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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Agency Contact: 

Jermolowicz Andrew 

Assistant Deputy Administrator 

Department of Agriculture 

Rural Business–Cooperative Service 

STOP 3250 

1400 Independence Avenue SW. 

Washington, DC 20250–3250 

Phone: 202 720–8460 

Fax: 202 720–4641 

Email: andrew.jermolowicz@wdc.usda.gov 

RIN: 0570–AA79 

USDA—Rural Utilities Service (RUS) 

FINAL RULE STAGE 

26. RURAL BROADBAND ACCESS 

LOANS AND LOAN GUARANTEES 

Priority: 

Other Significant 

Legal Authority: 

PL 107–171; 7 USC 901 et seq 

CFR Citation: 

7 CFR 1738 

Legal Deadline: 

None 

Abstract: 

On February 17, 2009, President Obama 

signed the American Recovery and 

Reinvestment Act of 2009 (Recovery 

Act) into law. The essential goal of the 

Recovery Act is to provide a ‘‘direct 

fiscal boost to help lift our Nation from 

the greatest economic crisis in our 

lifetimes and lay the foundation for 

future growth.’’ The Recovery Act 

expanded Rural Utilities Service’s 

(RUS’) existing authority to make loans 

and provides new authority to make 

grants to facilitate broadband 

deployment in rural areas. RUS has 

been tasked with the time-sensitive 

priority of developing the regulation for 

this new authority. The Agency will, 

however, also continue to develop a 

final rule for the Broadband Program 

as authorized by The Farm Security 

and Rural Investment Act of 2002, 

Public Law 107-171 (2002 Farm Bill). 

There has been more than $1.7 billion 

in loans for broadband deployment 

with more than 1,900 rural 

communities that will receive 

broadband services. Even with this 

level of success, the program needs to 

be adjusted to better serve unserved or 

underserved communities. In response, 

the RUS, an agency of the United States 

Department of Agriculture, revised the 

broadband rule to address this and 

other critical issues, and further 

facilitate the deployment of broadband 

service in rural America as directed by 

Congress by: (1) Clearly defining served 

and underserved markets based on 

service availability and existing 

competitors and target unserved in 

underserved areas; (2) providing 

potential applicants with a clear 

definition of which communities are 

eligible for funding; (3) establishing a 

minimum data transmission rate that 

the facilities financed must be able to 

deliver to the consumer; (4) 

establishing equity requirements that 

mitigate risks; (5) modifying market 

survey requirements based on service 

territories and existing availability of 

service; and (6) imposing new time 

limits for build-out and deployment to 

ensure prudent use of loan funds and 

timely delivery services to rural 

customers. A proposed rule was 

published in May 2007 seeking 

comments from interested parties. 

Subsequently, the rulemaking process 

was suspended in light of new statutory 

requirements provided in the 2008 

Farm Bill, thus requiring further 

rulemaking activities. 

Statement of Need: 

Since the Broadband Loan Program’s 

inception, the Agency has faced and 

continues to face significant challenges 

in administering the program, including 

the fierce competitive nature of the 

broadband market, the fact that many 

companies proposing to offer 

broadband service are start-up 

organizations with limited resources, 

continually evolving technology, and 

economic factors such as the higher 

cost of serving rural communities. 

Because of these challenges, the Agency 

has been reviewing the characteristics 

of the Broadband Loan Program and 

has determined that modifications are 

required to accelerate the deployment 

of broadband service to the rural areas 

of the country. 

The Broadband Loan Program is 

important to the revitalization of our 

rural communities and their economies. 

A lack of private capital has been cited 

as a reason for slow broadband 

deployment. However, an adequate 

supply of investment capital alone may 

not be sufficient to universally deploy 

broadband facilities in rural America— 

primarily due to the high cost of 

deployment outside of more densely 

populated areas. Due to market 

uncertainties and risks associated with 

startup ventures, non-Federal sources of 

funding are restricting and raising the 

cost of capital, particularly in costly 

rural markets. Better access to low-cost 

capital is a primary initiative of this 

program in facilitating an increase in 

the rate of rural broadband deployment. 

Summary of Legal Basis: 

On May 13, 2002, the Farm Security 

and Rural Investment Act of 2002, 

Public Law 107-171 (‘‘2002 Farm Bill’’), 

was signed into law. Title VI of the 

Farm Bill authorized the Agency to 

approve loans and loan guarantees for 

the costs of construction, improvement, 

and acquisition of facilities and 

equipment for broadband service in 

eligible rural communities. On June 18, 

2008, the Food, Conservation, and 

Energy Act of 2008 (‘‘2008 Farm Bill’’) 

became law, significantly changing the 

statutory requirements of the 

Broadband Loan Program. As such, the 

Agency will be issuing a Interim Rule 

that implements the statutory changes 

and requests comment on sections of 

the rule that were not part of the 

Proposed Rule published in May 2007. 

Anticipated Cost and Benefits: 

The program costs associated with 

lending activity are relatively low. The 

average subsidy rate since the 

program’s inception is 2.4 percent, or 

$24,000 in appropriated budget 

authority for every $1 million in loans. 

The residents and businesses of rural 

communities are the beneficiaries. 

Rural Development is responsible for 

helping rural America transition from 

an agricultural base economy to a 

platform for new business and 

economic opportunity. Rural 

Development seeks to leverage its 

financial resources with private 

investment to facilitate the 

development of the changing rural 

economy. The Broadband Loan Program 

provides rural America with the 

platform on which to achieve these 

goals. With access to the same 

advanced telecommunications networks 

as its urban counterparts, especially 

broadband networks designed to 

accommodate distance learning, 

telework, and telemedicine, rural 

America will eventually see improving 

educational opportunities, health care, 

economies, safety and security, and 

ultimately higher employment. The 

Agency shares the assessment of 

Congress, State and local officials, 

industry representatives, and rural 

residents that broadband service is a 

critical component to the future of rural 

America. The Agency is committed to 

ensuring that rural America will have 

access to affordable, reliable, broadband 


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services, and to provide a healthy, safe 

and prosperous place to live and work. 

Risks: 

Building broadband infrastructure in 

sparsely populated rural communities 

is very capital intensive. The 

Broadband Loan Program continues to 

face risk factors that pose challenges in 

ensuring that proposed projects can and 

do deliver robust, affordable broadband 

services to rural consumers. These 

factors include the competitive nature 

of the broadband market, the fact that 

many companies proposing to offer 

broadband service are start-up 

organizations with limited resources, 

rapidly evolving technology, and 

economic factors such as the higher 

cost of serving rural communities. 

While many of the smallest rural 

communities understand the 

importance of broadband infrastructure 

to their economic development, they 

often have difficulty attracting service 

providers to their communities. 

Timetable: 

Action Date FR Cite 

NPRM 05/11/07 72 FR 26742 

NPRM Comment 

Period End 

07/10/07 

Interim Final Rule 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Agency Contact: 

Michele L. Brooks 

Director, Program Development and 

Regulatory Analysis 

Department of Agriculture 

Rural Utilities Service 

Room 5159 South Building 

STOP 1522 

1400 Independence Avenue SW 

Washington, DC 20250 

Phone: 202 690–1078 

Fax: 202 720–8435 

Email: michele.brooks@usda.gov 

RIN: 0572–AC06 

BILLING CODE 3410–90–S 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79496 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

DEPARTMENT OF COMMERCE (DOC) 

Statement of Regulatory and 

Deregulatory Priorities 

The President’s fiscal year (FY) 2010 

Budget details how this Administration 

plans to lift our economy out of 

recession and lay a new foundation for 

long-term growth and prosperity. The 

Department of Commerce (the 

‘‘Department’’ or ‘‘Commerce’’) is 

aligning itself to contribute to both of 

these goals. 

Established in 1903, the Department 

of Commerce is one of the oldest 

Cabinet-level agencies in the Federal 

Government. The Department’s mission 

is to create the conditions for economic 

growth and opportunity by promoting 

innovation, entrepreneurship, 

competitiveness, and environmental 

stewardship. Commerce has 12 

operating units, which are responsible 

for managing a diverse portfolio of 

programs and services, ranging from 

trade promotion and economic 

development assistance to broadband 

and the National Weather Service. The 

Department currently employs 

approximately 53,000 people around the 

world, although this workforce doubled 

temporarily in 2010, due to the 

decennial census. 

The Department touches Americans 

daily, in many ways—making possible 

the daily weather reports and survey 

research; facilitating technology that all 

of us use in the workplace and in the 

home each day; supporting the 

development, gathering, and 

transmission of information essential to 

competitive business; enabling the 

diversity of companies and goods found 

in America’s and the world’s 

marketplace; and supporting 

environmental and economic health for 

the communities in which Americans 

live. 

Commerce has a clear and compelling 

vision for itself, for its role in the 

Federal Government, and for its roles 

supporting the American people, now 

and in the future. To achieve this vision, 

the Department works in partnership 

with businesses, universities, 

communities, and workers to: 

• Innovate by creating new ideas 

through cutting-edge science and 

technology from advances in 

nanotechnology, to ocean exploration, 

to broadband deployment, and by 

protecting American innovations 

through the patent and trademark 

system; 

• Support entrepreneurship and 

commercialization by enabling 

community development and 

strengthening minority businesses 

and small manufacturers; 

• Maintain U.S. economic 

competitiveness in the global 

marketplace by promoting exports, 

ensuring a level playing field for U.S. 

businesses, and ensuring that 

technology transfer is consistent with 

our Nation’s economic and security 

interests; 

• Provide effective management and 

stewardship of our Nation’s resources 

and assets to ensure sustainable 

economic opportunities; and 

• Make informed policy decisions and 

enable better understanding of the 

economy by providing accurate 

economic and demographic data. 

The Department is a vital resource 

base, a tireless advocate, and Cabinetlevel voice for job creation. 

The Regulatory Plan tracks the most 

important regulations that implement 

these policy and program priorities, 

several 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) will be 

planning actions that are considered the 

‘‘most important’’ significant 

preregulatory or regulatory actions for 

FY 2010. During the next year, NOAA 

plans to publish four rulemaking actions 

that are designated as Regulatory Plan 

actions. Further information on these 

actions is provided below. 

The Department has a long-standing 

policy to prohibit 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 

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 and climate services vital 

to public safety and to the Nation’s 

economy, such as weather forecasts, 

drought 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 designed to boost long-term 

economic growth in a vital sector of the 

U.S. economy while conserving the 

resources in the public trust and 

minimizing any economic dislocation 

necessary to ensure 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 threatened and 

endangered marine and anadromous 

species and 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 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, 


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assessments, and forecasts of 

environmental phenomena on which 

resource management, adaptation, and 

other societal decisions can be made. 

In the environmental stewardship 

area, NOAA’s goals include: Rebuilding 

and maintaining strong U.S. fisheries by 

using market-based tools and ecosystem 

approaches to management; increasing 

the populations of depleted, threatened, 

or endangered species and 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: 

Understanding climate change science 

and impacts, and communicating that 

understanding to government and 

private sector stakeholders enabling 

them to adapt; continually improving 

the National Weather Service; 

implementing reliable seasonal and 

interannual climate forecasts to guide 

economic planning; providing sciencebased policy advice on options to deal 

with very long-term (decadal to 

centennial) changes in the environment; 

and advancing and improving shortterm warning and forecast services for 

the entire environment. 

Magnuson-Stevens Fishery Conservation 

and Management Act 

Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act) rulemakings 

concern the conservation and 

management of fishery resources in the 

U.S. Exclusive Economic Zone 

(generally 3-200 nautical miles). Among 

the several hundred rulemakings that 

NOAA plans to issue in fiscal year 2010, 

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. NOAA issues 

regulations to implement FMPs and 

FMP amendments. Once a rulemaking is 

triggered by an FMC, the MagnusonStevens Act places stringent deadlines 

upon NOAA by which it must exercise 

its rulemaking responsibilities. FMPs 

and FMP amendments for Atlantic 

highly migratory species, such as 

bluefin tuna, swordfish, and sharks, are 

developed directly by NOAA, not by 

FMCs. 

FMPs address a variety of issues 

including maximizing fishing 

opportunities on healthy stocks, 

rebuilding overfished stocks, and 

addressing gear conflicts. One of the 

problems that FMPs may address is 

preventing overcapitalization 

(preventing excess fishing capacity) of 

fisheries. This may be resolved by 

market-based systems such as catch 

shares, which permit shareholders to 

harvest a quantity of fish and which can 

be traded on the open market. Harvest 

limits based on the best available 

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. 

Marine Mammal Protection Act 

The Marine Mammal Protection Act 

of 1972 (MMPA) provides the authority 

for the conservation and management of 

marine mammals under U.S. 

jurisdiction. It expressly prohibits, with 

certain exceptions, the take of marine 

mammals. Exceptions allow for 

permitting the collection of wild 

animals for scientific research or public 

display or to enhance the survival of a 

species or stock. NMFS initiates 

rulemakings under the MMPA to 

establish a management regime to 

reduce marine mammal mortalities and 

injuries as a result of interactions with 

fisheries. The Act also established the 

Marine Mammal Commission, which 

makes recommendations to the 

Secretaries of the Departments of 

Commerce and the Interior and other 

Federal officials on protecting and 

conserving marine mammals. The Act 

underwent significant changes in 1994 

to allow for takings incidental to 

commercial fishing operations, to 

provide certain exemptions for 

subsistence and scientific uses, and to 

require the preparation of stock 

assessments for all marine mammal 

stocks in waters under U.S. jurisdiction. 

Endangered Species Act 

The Endangered Species Act of 1973 

(ESA) provides for the conservation of 

species that are determined to be 

‘‘endangered’’ or ‘‘threatened,’’ and the 

conservation of the ecosystems on 

which these species depend. The ESA 

authorizes both NMFS and the Fish and 

Wildlife Service (FWS) to jointly 

administer the provisions of the Act. 

NMFS manages marine and 

‘‘anadromous’’ species, and FWS 

manages land and freshwater species. 

Together, NMFS and FWS work to 

protect critically imperiled species from 

extinction. Of the 1,310 listed species 

found in part or entirely in the United 

States and its waters, NMFS has 

jurisdiction over approximately 60 

species. NMFS’ rulemaking actions are 

focused on determining whether any 

species under its responsibility is an 

endangered or threatened species and 

whether those species must be added to 

the list of protected species. NMFS is 

also responsible for designating, 

reviewing, and revising critical habitat 

for any listed species. In addition, under 

the ESA’s procedural framework, 

Federal agencies consult with NMFS on 

any proposed action authorized, funded, 

or carried out by that agency that may 

affect one of the listed species or 

designated critical habitat, or is likely to 

jeopardize proposed species or 

adversely modify proposed critical 

habitat that is under NMFS’ jurisdiction. 

NOAA’s Regulatory Plan Actions 

While most of the rulemakings 

undertaken by NOAA do not rise to the 

level necessary to be included in the 

Department’s regulatory plan, NMFS is 

undertaking four actions that rise to the 

level of ‘‘most important’’ of the 

Department’s significant regulatory 

actions and thus are included in this 

year’s regulatory plan. The four actions 

implement provisions of the MagnusonStevens Fishery Conservation and 

Management Act, as reauthorized in 

2006. The first action may be of 


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particular interest to international 

trading partners as it concerns the 

Certification of Nations Whose Fishing 

Vessels are Engaged in Illegal, 

Unreported, or Unregulated Fishing or 

Bycatch of Protected Living Marine 

Resources. A description of the four 

regulatory plan actions is provided 

below. 

1. Certification of Nations Whose 

Fishing Vessels Are Engaged in 

Illegal, Unreported, or Unregulated 

Fishing or Bycatch of Protected Living 

Marine Resources (0648-AV51). 

NOAA’s NMFS is establishing a 

process of identification and 

certification to address illegal, 

unreported, or unregulated (IUU) 

activities and bycatch of protected 

species in international fisheries. 

Nations whose fishing vessels engage, 

or have been engaged, in IUU fishing 

would be identified in a biennial 

report to Congress, as required under 

section 403 of the Magnuson-Stevens 

Fishery Conservation and 

Management Act. NMFS would 

subsequently certify whether 

identified nations have taken 

appropriate corrective action with 

respect to the activities of its fishing 

vessels. 

2. Pacific Coast Groundfish Trawl 

Rationalization Program—Program 

Components Rulemaking (0648- 

AY68): Due to the complexity of the 

fishery management measures, NMFS 

is implementing the Pacific Coast 

Groundfish Trawl Rationalization 

Program through multiple 

rulemakings. A previous rulemaking 

(i.e., the Initial Issuance rule) creates 

and issues quota shares to qualified 

participants and establishes an 

appeals process. The program 

components rulemaking would 

implement the second phase of the 

trawl rationalization program. In 

particular, this rulemaking includes 

requirements for observers and 

compliance monitors, retention 

requirements, coop permits and 

agreements, first receiver site licenses, 

vessel accounts and mandatory 

economic data collection. 

3. Designation of Critical Habitat for 

Cook Inlet Beluga Whale (0648- 

AX50): This rule would designate 

critical habitat in two areas of Cook 

Inlet totaling 3,016 square miles. 

Critical habitat would include 

intertidal and subtidal waters near 

high and medium flow anadromous 

fish streams. The deadline for 

publication is October 20, 2010. 

4. Critical Habitat for North Atlantic 

Right Whales (0648-AY54): Northern 

right whales have been listed as 

endangered since 1973. In 2008, 

NOAA removed Northern right 

whales from the list of endangered 

species and replaced it with two 

separate species (North Pacific and 

North Atlantic right whales). NOAA 

had designated critical habitat for 

Northern right whales but has not yet 

designated critical habitat for the new 

North Atlantic right whale species. 

Several environmental groups 

threaten litigation over the failure to 

designate critical habitat for the 

species listed in 2008. NOAA is 

discussing a possible schedule for 

critical habitat designation that would 

avoid litigation. 

At this time, NOAA is unable to 

determine the aggregate cost of the 

identified Regulatory Plan actions as 

several of these actions are currently 

under development. 

Bureau of Industry and Security 

The Bureau of Industry and Security 

(BIS) advances U.S. national security, 

foreign policy, and economic objectives 

by maintaining and strengthening an 

adaptable, efficient, and effective export 

control and treaty compliance systems. 

BIS also administers programs to 

prioritize certain contracts to promote 

the national defense and to protect and 

enhance the defense industrial base. 

In August 2009, the President directed 

a broad-based interagency review of the 

U.S. export control system with the goal 

of strengthening national security and 

the competitiveness of key U.S. 

manufacturing and technology sectors 

by focusing on the current threats and 

adapting to the changing economic and 

technological landscape. In August 

2010, the President outlined an 

approach under which agencies that 

administer export controls will apply 

new criteria for determining what items 

need to be controlled and a common set 

of policies for determining when an 

export license is required. The control 

list criteria are to be based on 

transparent rules, which will reduce the 

uncertainty faced by our Allies, U.S. 

industry, and its foreign partners, and 

will allow the government to erect 

higher walls around the most sensitive 

items in order to enhance national 

security. 

Under the President’s approach, 

agencies will apply the criteria and 

revise the lists of munitions and dual 

use items that are controlled for export 

so that they: 

• Are ‘‘tiered’’ to distinguish the types 

of items that should be subject to 

stricter or more permissive levels of 

control for different destinations, enduses, and end-users; 

• Create a ‘‘bright line’’ between the two 

current control lists to clarify 

jurisdictional determinations and 

reduce government and industry 

uncertainty about whether particular 

items are subject to the control of the 

State Department or the Commerce 

Department; and 

• Are structurally aligned so that they 

potentially can be combined into a 

single list of controlled items. 

BIS’ current regulatory plan action is 

designed to implement the initial phase 

of the President’s directive. 

Major Programs and Activities 

BIS administers four sets of 

regulations. The Export Administration 

Regulations (EAR) regulate exports and 

reexports to protect national security, 

foreign policy, and short supply 

interests. The EAR also regulate 

participation of U.S. persons in certain 

boycotts administered by foreign 

governments. The National Defense 

Industrial Base Regulations provide for 

prioritization of certain contracts and 

allocations of resources to promote the 

national defense, require reporting of 

foreign government imposed offsets in 

defense sales, and address the effect of 

imports on the defense industrial base. 

The Chemical Weapons Convention 

Regulations implement declaration, 

reporting, and on-site inspection 

requirements in the private sector 

necessary to meet United States treaty 

obligations under Chemical Weapons 

Convention treaty. The Additional 

Protocol Regulations implement similar 

requirements with respect to an 

agreement between the United States 

and the International Atomic Energy 

Agency. 

BIS also has an enforcement 

component with eight field offices in 

the United States. BIS export control 

officers are stationed at several U.S. 

embassies and consulates abroad. BIS 

works with other U.S. Government 

agencies to promote coordinated U.S. 

Government efforts in export controls 

and other programs. BIS participates in 

U.S. Government efforts to strengthen 

multilateral export control regimes and 

to promote effective export controls 

through cooperation with other 

governments. 

BIS’ Regulatory Plan Actions 

As the agency responsible for leading 

administration and enforcement of the 


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U.S. dual-use export control system, BIS 

is playing a central role in the 

Administration’s efforts to 

fundamentally reform the export control 

system. Changing what we control, how 

we control it and how we enforce and 

manage our controls will help 

strengthen our national security by 

focusing our efforts on controlling the 

most critical products and technologies 

and by enhancing the competitiveness 

of key U.S. manufacturing and 

technology sectors. In accordance with 

the President’s directive to develop a 

system that is tiered to distinguish the 

types of items that should be subject to 

stricter or more permissive levels of 

control for different destinations, enduses, and end-users, BIS is developing 

a rule to implement an Export Control 

Tier Based License Exception. This rule 

would allow certain dual-use items to 

be exported and reexported with 

conditions to specific countries without 

a license that would otherwise be 

required. 

BIS will also be developing other 

rules to implement additional aspects of 

the export control reform as those 

aspects are identified and decided. 

International Trade Administration 

The International Trade 

Administration (ITA) assists in the 

development of U.S. trade policy in the 

global economy; creates jobs and 

economic growth by promoting U.S. 

companies; strengthens American 

competitiveness across all industries; 

addresses market access and compliance 

issues; administers U.S. trade laws; and 

undertakes a range of trade promotion 

and trade advocacy efforts. 

Import Administration 

The Import Administration (IA) is the 

ITA’s lead unit on enforcing trade laws 

and agreements to prevent unfairly 

traded imports and to safeguard jobs 

and the competitive strength of 

American industry. From working to 

resolve disputes to implementing 

measures when violations are found, we 

are there to protect U.S. companies from 

unfair trade practices. 

The primary role of IA is to enforce 

effectively the U.S. unfair trade laws 

(i.e., the antidumping duty (AD) and 

countervailing duty (CVD) laws) and to 

develop and implement other policies 

and programs aimed at countering 

foreign unfair trade practices. IA also 

administers the Foreign Trade Zones 

program, the Statutory Import Program 

and certain sector-specific agreements 

and programs, such as the Textiles and 

Apparel Program and the Steel Import 

Monitoring and Analysis licensing 

system. 

AD proceedings focus on whether 

foreign producers/exporters are selling 

their merchandise in the United States 

at less than fair value. CVD proceedings 

focus on whether foreign 

producers/exporters are benefitting from 

subsidies provided by their 

governments. Parties who participate in 

AD/CVD proceedings include U.S. 

manufacturers, U.S. importers, and 

foreign exporters and manufacturers, 

some of whom are affiliated with U.S. 

companies. 

ITA’s Regulatory Plan Actions 

IA is developing a rule entitled, 

‘‘Antidumping and Countervailing Duty 

Proceedings: Electronic Filing 

Procedures; Administrative Protective 

Order Procedures’’ to implement an 

electronic filing and records 

management system called IA’s 

Antidumping and Countervailing Duty 

Centralized Electronic Service System 

(IA ACCESS). The Department’s 

regulations currently require parties to 

submit multiple copies of a public 

document, and additional copies if the 

document contains business proprietary 

information. Alternatively, under the 

current regulations, if a document 

contains business proprietary 

information, a party must submit one 

hard copy original and five hard copies 

of a business proprietary document and 

three copies of a public version. The 

proposed rule will require interested 

parties to use IA ACCESS to file 

submissions electronically, unless an 

exception for manual, hard copy filing 

is applicable. If a document must be 

filed manually, the proposed rule also 

reduces the required number of copies 

for manual submissions such that only 

one paper copy of the submission will 

need to be filed with the Department. 

In addition to electronic filing, the 

goal of the IA ACCESS system is to 

expand the public’s access to 

information in AD/CVD proceedings by 

making all publicly filed documents 

available on the internet. It will also 

allow interested parties to file all 

submissions (both public and business 

proprietary) with the Department using 

an internet connection. The Department 

envisions that such a system will create 

efficiencies in both the process and 

costs associated with filing and 

maintaining the documents. The ease of 

document submission will increase 

accessibility of submission to the 

Department by interested parties located 

within and outside the Washington, DC 

area. 

Foreign-Trade Zones Board 

The Foreign-Trade Zones (FTZ) Board 

is an interagency board composed of the 

Secretary of Commerce and the 

Secretary of the Treasury. The Secretary 

of Commerce is the chairman of the 

Board. The FTZ Board administers the 

Foreign-Trade Zones Act of 1934, as 

amended (19 U.S.C. section 81a et seq.) 

(FTZ Act). 

Major Program and Activities 

The FTZ Board administers the FTZ 

program of the United States, pursuant 

to the FTZ Act and the FTZ regulations, 

codified at 15 CFR part 400. FTZs are 

restricted-access sites in or near U.S. 

Customs and Border Protection (CBP) 

ports of entry licensed by the FTZ Board 

and operated under the supervision of 

CBP. FTZs are locations into which 

foreign and domestic merchandise may 

be moved for operations involving 

storage, exhibition, assembly, 

manufacture, or other processing not 

prohibited by law. FTZs are considered 

outside of U.S. customs territory, which 

means that the usual customs entry 

procedures and payment of duties are 

not required on foreign merchandise 

admitted into an FTZ unless and until 

that merchandise enters U.S. customs 

territory for domestic consumption. 

The fact that FTZs are considered 

outside of U.S. customs territory makes 

them a valuable resource for many 

businesses. An FTZ user can avoid 

payment of U.S. customs duties on 

foreign merchandise admitted into an 

FTZ and then re-exported after further 

processing or manufacturing. Further, in 

some circumstances an FTZ user can 

admit foreign merchandise into an FTZ 

for use in manufacturing, and then, 

upon entry of the manufactured product 

into the U.S. customs territory, pay 

customs duties at the rate for the 

manufactured product. This can result 

in significant duty savings. Therefore, 

the FTZ program encourages retention 

of employment in the United States and 

promotion of export activity. 

The FTZ Board reviews and approves 

applications for authority to establish 

FTZs and to conduct certain activity 

within FTZs. It has the authority to 

restrict or prohibit activity in FTZs. 

Under the FTZ Act, FTZs must be 

operated under public utility principles 

and provide uniform treatment to all 

that apply to use the FTZ. The FTZ 

Board ensures that FTZs are operated in 

the public interest. 


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79500 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

The FTZ Board’s Regulatory Plan 

Actions 

The FTZ Board is in the process of 

revising its regulations, which have 

been in effect since 1990, in a proposed 

rule entitled, ‘‘Foreign-Trade Zones in 

the United States.’’ The new proposed 

rule was sent to OMB for review on 

August 31, 2010 (RIN 0625-AA81). The 

proposed rule will streamline 

application procedures and improve 

access to FTZs. For example, the FTZ 

Board is proposing to eliminate the need 

for advance Board approval of many 

types of manufacturing operations. This 

will allow businesses, including small 

businesses, to take advantage of 

manufacturing opportunities in FTZs 

more quickly and more in keeping with 

the pace of modern business, because 

they will not need to wait through the 

sometimes lengthy application process. 

Further, the proposed rule will provide 

guidance on the FTZ Act’s requirements 

that FTZs be operated as public utilities 

with uniform access to all users. This 

aspect of the proposed rule will improve 

access to the job-retention and exportpromotion benefits of FTZs. The 

proposed rule also will provide greater 

clarity on various other aspects of the 

FTZ program, such as the FTZ Board’s 

statutory fining authority. 

DOC—National Oceanic and 

Atmospheric Administration (NOAA) 

PROPOSED RULE STAGE 

27. DESIGNATION OF CRITICAL 

HABITAT FOR THE NORTH ATLANTIC 

RIGHT WHALE 

Priority: 

Other Significant 

Legal Authority: 

16 USC 1361 et seq; 16 USC 1531 to 

1543 

CFR Citation: 

50 CFR 226; 50 CFR 229 

Legal Deadline: 

None 

Abstract: 

In June 1970, the Northern right whale 

was listed as endangered under the 

Endangered Species Conservation Act, 

the precursor to the Endangered 

Species Act (ESA)(35 FR 8495; codified 

at 50 CFR 17.11). Subsequently, right 

whales were listed as endangered under 

the ESA in 1973, and as depleted under 

the Marine Mammal Protection Act 

(MMPA) the same year. In 1994, NMFS 

designated critical habitat for the 

Northern right whale, a single species 

thought at the time to include right 

whales in both the North Atlantic and 

the North Pacific. 

In 2006, NMFS published a 

comprehensive right whale status 

review that concluded that recent 

genetic data provided unequivocal 

support to distinguish three right whale 

lineages (including the southern right 

whale) as separate phylogenetic species 

(Rosenbaum et al. 2000). Rosenbaum et 

al. (2000) concluded that the right 

whale should be regarded as the 

following three separate species: (1) 

The North Atlantic right whale 

(Eubalaena glacialis) ranging in the 

North Atlantic Ocean; (2) the North 

Pacific right whale (Eubalaena 

japonica), ranging in the North Pacific 

Ocean; and (3) the southern right whale 

(Eubalaena australis), historically 

ranging throughout the southern 

hemisphere’s oceans. 

Based on these findings, NMFS 

published a proposed and final 

determination listing right whales in 

the North Atlantic and North Pacific as 

separate endangered species under the 

ESA (71 FR 77704, December 27, 2006; 

73 FR 12024, March 6, 2008). Based 

on the new listing determination, 

NMFS is required by the ESA to 

designate critical habitat separately for 

both the North Atlantic right whale and 

the North Pacific right whale. 

In April 2008, a final critical habitat 

determination was published for the 

North Pacific right whale (73 FR 19000; 

April 8, 2008). At this time, NMFS is 

preparing a proposal to designate 

critical habitat for the North Atlantic 

right whale. 

Statement of Need: 

In June 1970, the Northern right whale 

was listed as endangered under the 

Endangered Species Conservation Act, 

the precursor to the Endangered 

Species Act (ESA)(35 FR 8495; codified 

at 50 CFR 17.11). Subsequently, right 

whales were listed as endangered under 

the ESA in 1973 and as depleted under 

the Marine Mammal Protection Act 

(MMPA) the same year. In 1994, NMFS 

designated critical habitat for the 

Northern right whale, a single species 

thought at the time to include right 

whales in both the North Atlantic and 

the North Pacific. 

In 2006, NMFS published a 

comprehensive right whale status 

review that concluded that recent 

genetic data provided unequivocal 

support to distinguish three right whale 

lineages (including the southern right 

whale) as separate phylogenetic species 

(Rosenbaum et al. 2000). Rosenbaum et 

al. (2000) concluded that the right 

whale should be regarded as the 

following three separate species: (1) 

The North Atlantic right whale 

(Eubalaena glacialis) ranging in the 

North Atlantic Ocean; (2) the North 

Pacific right whale (Eubalaena 

japonica), ranging in the North Pacific 

Ocean; and (3) the southern right whale 

(Eubalaena australis), historically 

ranging throughout the southern 

hemisphere’s oceans. 

Based on these findings, NMFS 

published a proposed and final 

determination listing right whales in 

the North Atlantic and North Pacific as 

separate endangered species under the 

ESA (71 FR 77704, December 27, 2006; 

73 FR 12024, March 6, 2008). Based 

on the new listing determination, 

NMFS is required by the ESA to 

designate critical habitat separately for 

both the North Atlantic right whale and 

the North Pacific right whale. 

In April 2008, a final critical habitat 

determination was published for the 

North Pacific right whale (73 FR 19000; 

April 8, 2008). At this time, NMFS is 

preparing a proposal to designate 

critical habitat for the North Atlantic 

right whale. 

Summary of Legal Basis: 

Endangered Species Act 

Alternatives: 

Because this rule is presently in the 

beginning stages of development, no 

alternatives have been formulated or 

analyzed at this time. 

Anticipated Cost and Benefits: 

Because this rule is presently in the 

beginning stages of development, no 

analysis has been completed at this 

time to assess costs and benefits. 

Risks: 

Loss of critical habitat for a species 

listed as protected under the ESA and 

MMPA, as well as potential loss of 

right whales due to habitat loss. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 


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Government Levels Affected: 

None 

Agency Contact: 

Marta Nammack 

Office of Protected Resources 

Department of Commerce 

National Oceanic and Atmospheric 

Administration 

1315 East–West Highway 

Silver Spring, MD 20910 

Phone: 301 713–1401 

Fax: 301 427–2523 

Email: marta.nammack@noaa.gov 

RIN: 0648–AY54 

DOC—NOAA 

FINAL RULE STAGE 

28. CERTIFICATION OF NATIONS 

WHOSE FISHING VESSELS ARE 

ENGAGED IN ILLEGAL, 

UNREPORTED, AND UNREGULATED 

FISHING OR BYCATCH OF 

PROTECTED LIVING MARINE 

RESOURCES 

Priority: 

Other Significant 

Legal Authority: 

16 USC 1801 et seq; 16 USC 1826(d) 

to 1826(k) 

CFR Citation: 

50 CFR 300 

Legal Deadline: 

Final, Statutory, January 12, 2011, 

Report due to Congress 16 USC 1826h. 

Report on countries identified as 

having vessels engaged in IUU fishing. 

Abstract: 

The National Marine Fisheries Service 

(NMFS) is establishing a process of 

identification and certification to 

address illegal, unreported, or 

unregulated (IUU) activities and 

bycatch of protected species in 

international fisheries. Nations whose 

fishing vessels engage, or have been 

engaged, in IUU fishing or bycatch of 

protected living marine resources 

would be identified in a biennial report 

to Congress, as required under section 

403 of the Magnuson-Stevens Fishery 

Conservation and Management 

Reauthorization Act (MSRA) of 2006. 

NMFS would subsequently certify 

whether identified nations have taken 

appropriate corrective action with 

respect to the activities of its fishing 

vessels, as required under section 403 

of MSRA. 

Statement of Need: 

The National Oceanic and Atmospheric 

Administration (NOAA) National 

Marine Fisheries Service (NMFS) 

proposes regulations to set forth 

identification and certification 

procedures for nations whose vessels 

engage in illegal, unregulated, and 

unreported (IUU) fishing activities or 

bycatch of protected living marine 

resources pursuant to the High Seas 

Fishing Moratorium Protection Act 

(Moratorium Protection Act). 

Specifically, the Moratorium Protection 

Act requires the Secretary of Commerce 

to identify in a biennial report to 

Congress those foreign nations whose 

vessels are engaged in IUU fishing or 

fishing that results in bycatch of 

protected living marine resources. The 

Moratorium Protection Act also 

requires the establishment of 

procedures to certify whether nations 

identified in the biennial report are 

taking appropriate corrective actions to 

address IUU fishing or bycatch of 

protected living marine resources by 

fishing vessels of that nation. Based 

upon the outcome of the certification 

procedures developed in this 

rulemaking, nations could be subject to 

import prohibitions on certain fisheries 

products and other measures under the 

authority provided in the High Seas 

Driftnet Fisheries Enforcement Act if 

they are not positively certified by the 

Secretary of Commerce. 

Summary of Legal Basis: 

NOAA is proposing these regulations 

pursuant to its rulemaking authority 

under sections 609 and 610 of the High 

Seas Driftnet Fishing Moratorium 

Protection Act (16 U.S.C. 1826j and k), 

as amended by the Magnuson-Stevens 

Fishery Conservation and Management 

Reauthorization Act. 

Alternatives: 

NMFS developed alternatives for the 

Secretary of Commerce to make a 

positive certification that a nation, once 

identified as having vessels engaged in 

illegal, unregulated, and unreported 

(IUU) fishing, has taken sufficient 

corrective action against those vessels 

or is a member of a regional fishery 

management organization that has 

adopted effective measures to address 

the IUU activities. NMFS also 

developed alternatives for the Secretary 

of Commerce to make a positive 

certification that a nation, once 

identified as having vessels engaged in 

bycatch of protected living marine 

resources (PLMR), has adopted a 

regulatory program to conserve those 

PLMR that is comparable in 

effectiveness to the United States and 

which collects data to support 

international assessment and 

conservation efforts. 

Anticipated Cost and Benefits: 

Because this rule is under 

development, NMFS does not currently 

have estimates of the amount of 

product that is imported into the 

United States from other nations whose 

vessels are engaged in illegal, 

unreported, and unregulated (IUU) 

fishing or bycatch of protected living 

marine resources. Therefore, 

quantification of the economic impacts 

of this rulemaking is not possible at 

this time. This rulemaking has not been 

determined to be economically 

significant under E.O. 12866; however, 

it is considered significant because it 

raises novel or legal or policy issues 

arising out of legal mandates, the 

President’s Priorities, and the 

principles set forth in the Executive 

order. 

Risks: 

The risks associated with not pursuing 

the proposed rulemaking include 

allowing IUU fishing activities and/or 

bycatch of protected living marine 

resources by foreign vessels to continue 

without an effective tool to aid in 

combating such activities. 

Timetable: 

Action Date FR Cite 

ANPRM 06/11/07 72 FR 33436 

ANPRM Comment 

Period End 

07/05/07 

NPRM 01/14/09 74 FR 2019 

NPRM Comment 

Period End 

05/14/09 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 


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Agency Contact: 

Christopher Rogers 

Division Chief 

Department of Commerce 

National Oceanic and Atmospheric 

Administration 

1315 East–West Highway 

Silver Spring, MD 20910 

Phone: 301 713–9090 

Fax: 301 713–9106 

Email: christopher.rogers@noaa.gov 

Related RIN: Related to 0648–AV23 

RIN: 0648–AV51 

DOC—NOAA 

29. CRITICAL HABITAT DESIGNATION 

FOR COOK INLET BELUGA WHALE 

UNDER THE ENDANGERED SPECIES 

ACT 

Priority: 

Other Significant 

Legal Authority: 

16 USC 1531 et seq 

CFR Citation: 

50 CFR 226 

Legal Deadline: 

None 

Abstract: 

The National Marine Fisheries Service 

(NMFS) listed the Cook Inlet beluga 

whale Distinct Population Segment as 

endangered under the Endangered 

Species Act on October 17, 2009. 

NMFS is required to designate critical 

habitat no later than one year after the 

publication of a listing. NMFS intends 

to publish a proposed rule by October 

17, 2009. 

Statement of Need: 

The National Marine Fisheries Service 

(NMFS) listed the Cook Inlet beluga 

whale Distinct Population Segment as 

endangered under the Endangered 

Species Act on October 17, 2009. 

NMFS is required to designate critical 

habitat no later than one year after the 

publication of a listing. NMFS intends 

to publish a proposed rule by October 

17, 2009. 

Summary of Legal Basis: 

Endangered Species Act 

Alternatives: 

Alternative 1. No action (status quo): 

NMFS would not designate critical 

habitat (CH) in Cook Inlet, Alaska, for 

the Cook Inlet beluga whale. 

Conservation and recovery of the listed 

species would depend exclusively upon 

the protections provided under the 

‘‘jeopardy’’ provisions of Section 7 of 

the ESA. 

Alternative 2. Designate Area 1 and 

Area 2, which encompass all of upperCook Inlet, north of a line at 60° 25’ 

north latitude, and portions of mid- and 

lower-Cook Inlet, extending south along 

the west side of the Cook Inlet, 

following the tidal flats into Kamishak 

Bay to Douglas Reef, between MHHW 

and waters within two nautical miles 

of shore. It further includes all waters 

of Kachemak Bay, eastward of 151° 30’ 

west longitude and seaward of MHHW. 

Anticipated Cost and Benefits: 

The post-designation incremental costs 

are estimated to range from $187,000 

to $571,000, in present value terms, at 

a 3 percent discount rate, and from 

$157,000 to $472,000 at a 7 percent 

discount rate. 

Approximately six Federal action 

agencies for section 7 consultations are 

anticipated to bear 70 percent 

($398,000) of these costs, while 26 

percent ($148,000) are expected to 

accrue to NMFS, as the consulting 

agency. The remaining four percent 

($25,000) of these costs may be borne 

by third parties, during the 

consultations. Of the total costs to 

Federal action agencies, the DOD is 

anticipated to bear approximately 76 

percent ($302,000). This is followed by 

USACE (9 percent; $37,000), NMFS (7 

percent; $28,000), FERC (7 percent; 

$28,000), EPA (1 percent; $3,000), and 

FHWA (less than 1 percent; less than 

$1,000). 

Benefits are qualitative: Area more 

attractive to workers in various 

industrial sectors; anticipated 

conservation and recovery species; and 

the general stability in associated 

environs should provide increases in 

welfare to tourists, recreationists, 

wildlife watchers, Cook Inlet Ferry 

passengers, and future cruise ship 

passengers. This should result in higher 

revenues for relevant businesses. Other 

wildlife and fish species will benefit, 

resulting in overall improvements in 

commercial, recreational, personal use, 

and subsistence uses. The increase in 

Cook Inlet beluga whale populations, in 

the longer term, will provide more 

frequent subsistence harvest 

opportunities to the Alaska Natives and 

allow future generations to practice 

their traditional ways. It will enhance 

passive-use benefits among those who 

value this species and the myriad 

elements and aspects of the natural 

habitat that sustains it. Finally, as the 

ESA is carried out, there are expected 

to be scientific and educational benefits 

to the Nation. 

Risks: 

Loss of critical habitat for the Cook 

Inlet beluga whale Distinct Population 

Segment and connected loss of Cook 

Inlet beluga whale members. 

Timetable: 

Action Date FR Cite 

ANPRM 04/14/09 74 FR 17131 

ANPRM Comment 

Period End 

05/14/09 

NPRM 12/02/09 74 FR 63080 

NPRM Comment 

Period Extended 

01/12/10 75 FR 1582 

NPRM Comment 

Period End 

02/01/10 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions, 

Organizations 

Government Levels Affected: 

Federal, Local, State, Tribal 

Agency Contact: 

Marta Nammack 

Office of Protected Resources 

Department of Commerce 

National Oceanic and Atmospheric 

Administration 

1315 East–West Highway 

Silver Spring, MD 20910 

Phone: 301 713–1401 

Fax: 301 427–2523 

Email: marta.nammack@noaa.gov 

RIN: 0648–AX50 

DOC—NOAA 

30. FISHERIES OFF WEST COAST 

STATES; PACIFIC COAST 

GROUNDFISH FISHERY; 

AMENDMENTS 20 AND 21; TRAWL 

RATIONALIZATION PROGRAM 

Priority: 

Other Significant 

Legal Authority: 

16 USC 1801 et seq 

CFR Citation: 

50 CFR 660 

Legal Deadline: 

None 

Abstract: 

The trawl rationalization program 

creates an individual fishing quota 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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(IFQ) program for the shore-based trawl 

fleet; and cooperative (coop) programs 

for the at-sea trawl fleet in the Pacific 

Coast Groundfish Fishery. This 

rulemaking includes regulations to 

implement Amendments 20 and 21 to 

the Pacific Coast Groundfish Fishery 

Management Plan (FMP). Amendment 

20 creates the structure and 

management details of the trawl 

rationalization program, which would 

be a limited access privilege program 

(LAPP) under the Magnuson-Stevens 

Fishery Conservation and Management 

Act (MSA), as reauthorized in 2007. 

Amendment 21, intersector allocation, 

allocates the groundfish stocks between 

trawl and non-trawl fisheries. 

Statement of Need: 

The trawl rationalization program is 

intended to increase net economic 

benefits, create individual economic 

stability, provide full utilization of the 

trawl sector allocation, consider 

environmental impacts, and achieve 

individual accountability of catch and 

bycatch. This rule would establish the 

key components that would be 

necessary to implement the trawl 

rationalization program at the start of 

the 2011 fishery. 

Summary of Legal Basis: 

Section 303A of the Magnuson-Stevens 

Act. 

Alternatives: 

The Pacific Fishery Management 

Council (the Council) prepared two 

environmental impact statement (EIS) 

documents: Amendment 20— 

Rationalization of the Pacific Coast 

Groundfish Limited Entry Trawl 

Fishery, which would create the 

structure and management details of 

the trawl fishery rationalization 

program; and Amendment 21— 

Allocation of Harvest Opportunity 

Between Sectors of the Pacific Coast 

Groundfish Fishery, which would 

allocate the groundfish stocks between 

trawl and non-trawl fisheries. These 

EISs covered a range of alternatives. 

The Regulatory Impact Review and 

Initial Regulatory Flexibility Analysis 

(RIR/IRFA) for this rule focuses on the 

two key alternatives—the No-Action 

Alternative and the Preferred 

Alternative. By focusing on the two key 

alternatives (no action and preferred) in 

the RIR/IRFA, it encompasses parts of 

the other alternatives and informs the 

reader of these proposed regulations. 

Under the no action alternative, the 

current, primary management tool used 

to control the Pacific coast groundfish 

trawl catch includes a system of two 

month cumulative landing limits for 

most species and season closures for 

Pacific whiting. This management 

program would continue under the no 

action alternative. The analysis of the 

preferred alternative describes what is 

likely to occur as a result of the 

proposed action. Under the preferred 

alternative, the existing shore-based 

whiting and shore-based non-whiting 

sectors of the Pacific Coast groundfish 

limited entry trawl fishery would be 

managed as one sector under a system 

of IFQs, and the at-sea whiting sectors 

of the fishery would be managed under 

a system of sector-specific harvesting 

cooperatives (coops). 

Anticipated Cost and Benefits: 

The RIR/IRFA reviewed and 

summarized the benefits and costs, and 

the economic effects of the Council’s 

recommendations. The major 

conclusions of the economic model 

suggest that (with landings held at 2004 

levels), the current groundfish fleet 

(non-whiting component), which 

consisted of 117 vessels in 2004, will 

be reduced by roughly 50 percent to 

66 percent, or 40 to 60 vessels under 

an IFQ program. The reduction in fleet 

size implies cost savings of $18 to $22 

million for the year 2004 (most recent 

year of the data). Vessels that remain 

active will, on average, be more cost 

efficient and will benefit from 

economies of scale that are currently 

unexploited under controlled access 

regulations in the fishery. The cost 

savings estimates are significant, 

amounting to approximately half of the 

costs incurred currently, suggesting that 

IFQ management may be an attractive 

option for the Pacific Coast Groundfish 

Fishery. The increase in profits that 

commercial harvesters are expected to 

experience under the preferred 

alternative may render them better able 

to sustain the costs of complying with 

the new reporting and monitoring 

requirements. The costs of at-sea 

observers may reduce profits by about 

$2.2 million, depending on the fee 

structure. However, the profits earned 

by the non-whiting sector would still 

be substantially higher under the 

preferred alternative than under the no 

action alternative. 

Risks: 

Under the no action alternative, 

cumulative landing limits for target 

species have to be set lower because 

the bycatch of overfished species 

cannot be directly controlled. 

Introducing accountability at the 

individual vessel level by means of 

IFQs provides a strong incentive for 

bycatch avoidance. 

There will likely be a lower motivation 

to ‘‘race for fish’’ due to coop harvest 

privileges. This is expected to result in 

improved product quality, slower-paced 

harvest activity, increased yield (which 

should increase ex-vessel prices), and 

enhanced flexibility and ability for 

business planning. 

Timetable: 

Action Date FR Cite 

Notice of Availability 05/12/10 75 FR 26702 

First Proposed Rule 06/10/10 75 FR 32994 

First Proposed Rule 

Correction 

06/30/10 75 FR 37744 

First Proposed Rule 

Comment Period 

End 

07/12/10 

Second Proposed 

Rule 

08/31/10 75 FR 53379 

Second Proposed 

Rule Comment 

Period End 

09/30/10 

First Final Rule 10/01/10 75 FR 60868 

Second Final Rule 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses, Organizations 

Government Levels Affected: 

None 

Agency Contact: 

Barry Thom 

Regional Administrator, Northwest 

Region, NMFS 

Department of Commerce 

National Oceanic and Atmospheric 

Administration 

Building 1, 7600 Sand Point Way NE. 

Seattle, WA 48115–0070 

Phone: 206 526–6150 

Fax: 206 526–6426 

Email: barry.thom@noaa.gov 

Related RIN: Related to 0648–AX98 

RIN: 0648–AY68 

BILLING CODE 3510–12–S 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79504 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

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), 10 Unified 

Combatant Commands, 14 Defense 

agencies, and 10 DoD Field Activities. It 

has 1,434,761 military personnel and 

770,569 civilians assigned as of June 30, 

2010, 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 DoD, 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, 

Treasury, Commerce, and State, and the 

Office of Personnel Management, 

General Services Administration, and 

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 

regulatory agencies and the affected 

DoD 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 it issues regulations that 

have an effect 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 

affected by its regulations as well. 

Overall Priorities 

The Department 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, costeffective, and both fair and perceived as 

fair. This is being done in DoD while 

reacting 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, fully incorporates 

the provisions of the President’s 

priorities and objectives under 

Executive Order 12866. 

The Department also participates with 

GSA, NASA, and OFPP to form the 

Federal Acquisition Regulatory Council. 

The FAR Council assists in the direction 

and coordination of Government wide 

procurement policy and Government 

wide procurement regulator activities in 

the Federal Government (41 U.S.C. 421). 

Together, DOD, GSA, and NASA jointly 

issue and maintain the Federal 

Acquisition Regulation. 

Administration Priorities: 

1. Rulemakings that promote open 

Government and that use disclosure 

as a regulatory tool. 

The Department plans to: 

• Revise the Federal Acquisition 

Regulation (FAR) to inform 

contractors of this statutory 

requirement to make Federal Awardee 

Performance and Integrity Information 

System information, excluding past 

performance reviews, available to the 

public; 

• Finalize the FAR rule that implements 

the requirement for reporting first-tier 

subcontracting data for new contracts 

using Recovery Act funds; and 

• Finalize the FAR rule that implements 

the Federal Funding Accountability 

and Transparency Act of 2006, which 

requires the Office of Management 

and Budget (OMB) to establish a free, 

public, website containing full 

disclosure of all Federal contract 

award information. This rule requires 

contractors to report executive 

compensation and first-tier 

subcontractor awards on unclassified 

contracts expected to be $25,000 or 

more, except contracts with 

individuals. 

2. Rulemakings that simplify or 

streamline regulations and reduce or 

eliminate unjustified burdens. 

The Department plans to: 

• Revise the FAR to delete part 2 of the 

SF 330, which collects general 

qualifications data not related to a 

particular planned contract action. 

The Online Representations and 

Certifications Application (ORCA) 

now collects this data centrally from 

interested Architect-Engineer vendors 

at the time they complete the other 

representations and certifications in 

ORCA; 

• Revise the FAR to incorporate 

changes from a final Department of 

Labor rule that removes the 

requirement to submit complete social 

security numbers and home addresses 

of individual workers in weekly 

payroll submissions. Removal of this 

personal information from payroll 

records avoids unnecessary disclosure 

issues; 

• Finalize the revision of DFARS 

requirements for reporting the loss, 

theft, damage, or destruction of 

Government property; 

• Review of the DFARS requirements 

for reporting Government Furnished 

Equipment and Government 

Furnished Material in the DoD Item 

Unique Identification (IUID) registry; 

• Remove the DFARS requirement to 

use DD Forms 2626 and 2631 to report 

past performance information for 

construction and architect/engineer 

services instead of the standard FAR 

procedures; 

• Revise the DFARS to permit offerors 

to provide alternative line-item 

structure from that shown in the 

solicitation to reflect the offeror’s 

business practices for selling and 

billing commercial items and initial 

provisioning spares for weapon 

systems; 

• Delete redundant DFARS text that 

limits placement of orders against 

contracts with contractors that have 

been debarred suspended or proposed 

for debarment. This requirement is 

now incorporated into the FAR; 

• Propose changes to simplify and 

clarify the DFARS coverage of patents, 

data, and copyrights, dramatically 

reducing the amount of regulatory text 

and the number of required clauses; 

• Simplify and clarify the DFARS 

coverage of multiyear acquisitions; 

• Establish a method in the DFARS for 

electronic issuance of orders; and 

• Improve the contract closeout process. 

3. Regulations of Particular Interest to 

Small Business 

Of interest to small businesses are 

regulations to: 

• Implement in the FAR changes to the 

requirement for small disadvantaged 

businesses certification; 

• Revise the FAR to implement changes 

in the HUBZone Program, in 

accordance with Small Business 

Administration regulations; 


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• Consider revisions to the FAR to 

address the findings of the Rothe case 

that Federal contracting programs for 

minority-owned and other small 

businesses that implement 10 U.S.C. 

2323 are ‘‘facially’’ unconstitutional; 

• Establish a DoD program to enhance 

participation of Historically Black 

Colleges and Universities and 

Minority-Serving Institutions in 

defense research programs; 

• Conform the DFARS to the FAR with 

respect to the use of the Electronic 

Subcontracting Reporting System; and 

• Require public disclosure of 

justification and approval documents 

for noncompetitive 8(a) contracts over 

$20 million. 

4. Regulations with international effects 

or interest 

Of international effect or interest are 

regulations to: 

• Implement in the FAR statutory 

certification requirement that each 

offeror does not engage in any activity 

for which sanctions may be imposed 

under section 5 of the Iran Sanctions 

Act. Also implements a procurement 

prohibition relating to contracts with 

persons that export sensitive 

technology to Iran; 

• Establish in the FAR processes and 

criteria for waiver of the prohibition 

on contracting with entities that 

conduct restricted business operations 

in Sudan; 

• Implement in the DFARS the 

determinations regarding 

participation of South 

Caucasus/Central and South Asian 

states in acquisitions in support of 

operations in Afghanistan; 

• Finalize the FAR rule that prohibits 

Government contracts with any 

foreign incorporated entity that is 

treated as an inverted domestic 

corporation under section 835(b) of 

the Homeland Security Act of 2002 or 

any subsidiary of such entity; 

• Implement in the FAR and DFARS the 

annual consolidated appropriation act 

exemption from the Buy American 

Act/Balance of Payments Program 

restrictions on the acquisition of 

foreign commercial information 

technology items as construction 

material; and 

• Finalize in the FAR and DFARS the 

rules that increase trade agreements 

thresholds, as specified by the United 

States Trade Representative. 

Specific DoD Priorities: 

For this Regulatory Plan, there are 

seven 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 acquisition, security, 

homeowners, education, and health 

affairs. 

1. Regulatory Program of the U.S. Army 

Corps of Engineers 

In 1988, the Army Corps of Engineers 

published as appendix B of 33 CFR part 

325, a rule that governs compliance 

with the National Environmental Policy 

Act (NEPA) for the Army’s Regulatory 

Program. On April 2, 2010, the Assistant 

Secretary of the Army for Civil Works 

announced that the Army Corps of 

Engineers would conduct rulemaking to 

modify appendix B to reflect a limited 

change in policy addressing permit 

applications for surface coal mining 

activities in Appalachia. The 

modification of appendix B will focus 

on the NEPA scope of review for 

considering the effects of surface coal 

mining in Appalachia on the aquatic 

environment, to enhance protection of 

aquatic resources. 

2. Defense Procurement and Acquisition 

Policy 

The Department of Defense 

continuously reviews the DFARS and 

continues to lead Government efforts to: 

• Revise the DFARS to implement the 

Weapons System Acquisition Reform 

Act of 2009 – including acquisition 

strategies to ensure competition 

throughout life-cycle of major defense 

acquisition programs and address 

organizational conflicts of interest in 

major defense acquisition programs; 

• Revise DFARS to ensure continuation 

of contractor services in support of 

mission essential functions during an 

emergency, such as an influenza 

pandemic; 

• Clarify DoD policy in the DFARS 

regarding the definition and 

administration of contractor business 

systems to improve the effectiveness 

of DCMA/DCAA oversight of 

contractor business systems; 

• Implement in the DFARS statutory 

requirement to inspect military 

facilities, infrastructure, and 

equipment for safety and habitability 

prior to use; 

• Revise the FAR to implement the 

Executive orders relating to 

allowability of labor relations costs, 

non-displacement of qualified 

workers, notification of employee 

rights under Federal labor laws, and 

Federal leadership in environmental, 

energy, and economic performance; 

• Revise the FAR to adopt biobased 

procurement preferences and collect 

contractor information on use of 

biobased products; 

• Revise the FAR to address service 

contractor employee personal 

conflicts of interest and organizational 

conflicts of interest and limit 

contractor access to information; and 

• Provide enhanced competition for 

task- and delivery-order contracts and 

additional market research before 

awarding a task or delivery order in 

excess of the simplified acquisition 

threshold. 

3. Logistics and Materiel Readiness, 

Department of Defense 

The Department of Defense published 

or plans to publish rules on contractors 

supporting the military in contingency 

operations: 

• Final Rule: Private Security 

Contractors (PSCs) Operating in 

Contingency Operations. In order to 

meet the mandate of section 862 of 

the 2008 National Defense 

Authorization Act, this rule 

establishes policy, assigns 

responsibilities and provides 

procedures for the regulation of the 

selection, accountability, training, 

equipping, and conduct of personnel 

performing private security functions 

under a covered contract during 

contingency operations. It also assigns 

responsibilities and establishes 

procedures for incident reporting, use 

of and accountability for equipment, 

rules for the use of force, and a 

process for administrative action or 

the removal, as appropriate, of PSCs 

and PSC personnel. DoD published an 

interim final rule on July 17, 2009 (74 

FR 34690 to 34694) with an effective 

date of July 17, 2009. The comment 

period ended August 31, 2009. DoD, 

in coordination with the Department 

of State and the United States Agency 


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79506 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

for International Development, have 

prepared a final rule, which includes 

the responses to the public comments, 

and incorporates changes to the 

interim final rule, where appropriate. 

The final rule is expected to be 

published the first or second quarter 

of FY 2011. 

• Interim Final Rule: Operational 

Contract Support for Contingency 

Operations. This rule will incorporate 

the latest changes and lessons learned 

into policy and procedures for 

program management for the 

preparation and execution of 

contracted support and the integration 

of DoD contractor personnel into 

military contingency operations 

outside the United States. DoD 

anticipates publishing the interim 

final rule in the first or second quarter 

of FY 2011. 

4. Installations and Environment, 

Department of Defense 

The Department of Defense published 

a rule to assist eligible military and 

civilian Federal employee homeowners: 

• Final Rule: This rule authorizes the 

Homeowners Assistance Program 

(HAP) under section 3374 of title 42, 

United States Code, to assist eligible 

military and civilian Federal 

employee homeowners when the real 

estate market is adversely affected by 

closure or reduction-in-scope of 

operations. In accordance with DoD 

Directive 5101.1, ‘‘DoD Executive 

Agent,’’ designates the Secretary of 

the Army as the DoD Executive Agent 

for administering, managing, and 

executing the HAP. Additionally, this 

rule allows the Department of Defense 

to temporarily expand the existing 

HAP in compliance with section 1001 

of the American Recovery and 

Reinvestment Act of 2009. This 

temporary expansion covers certain 

persons affected by BRAC 2005, 

certain persons on permanent change 

of station orders, and certain 

wounded persons and surviving 

spouses. This rule updates policy, 

delegates authority, and assigns 

responsibilities for managing 

Expanded HAP. This is an 

economically significant rule. DoD 

published an interim final rule on 

September 30, 2009 (74 FR 50109- 

50115), with an effective date of 

September 30, 2009. The comment 

period ended October 30, 2009. The 

final rule published November 16, 

2010 (75 FR 69871) with an effective 

date of January 18, 2011. 

5. Military Personnel Policy, Department 

of Defense 

The Department of Defense published 

or plans to publish a rule implementing 

the Post-9/11 Veterans Educational 

Assistance Act of 2008, title V, Public 

Law 110-252 (the ‘‘Post-9/11 GI Bill’’): 

• Interim Final Rule: This rule 

establishes policy, assigns 

responsibilities, and prescribes 

procedures for carrying out the Post9/11 GI Bill. It establishes policy for 

the use of supplemental educational 

assistance ‘‘kickers,’’ for members 

with critical skills or specialties, or 

for members serving additional 

service; for authorizing the 

transferability of education benefits; 

and for the DoD Education Benefits 

Fund Board of Actuaries. DoD 

published an interim final rule on 

June 25, 2009 (74 FR 30212 to 30220) 

with an effective date of June 25, 

2009. The comment period ended July 

27, 2009. DoD anticipates finalizing 

this rule in the spring of 2011. 

6. Military Community and Family 

Policy, Department of Defense 

The Department of Defense published 

or plans to publish a rule to implement 

policy, assign responsibilities, and 

prescribe procedures for the operation 

of voluntary education programs within 

DoD. 

• Proposed Rule: This rule implements 

policy, assigns responsibilities, and 

prescribes procedures for the 

operation of voluntary education 

programs within DoD. Included are: 

Procedures for Service members 

participating in education programs; 

guidelines for establishing, 

maintaining, and operating voluntary 

education programs; procedures for 

obtaining on-base voluntary education 

programs and services; minimum 

criteria for selecting institutions to 

deliver higher education programs 

and services on military installations; 

and the Memorandum of 

Understanding between educational 

institutions and DoD prior to the 

disbursement of tuition assistance 

funds. This is an economically 

significant rule. The proposed rule 

published August 6, 2010 (75 FR 

47504-47515). The comment period 

ends October 5, 2010. DoD anticipates 

finalizing this rule in the spring or fall 

of FY 2011. 

7. 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 health care providers, facilities, 

and services under contract to DoD 

through the TRICARE program. 

TRICARE is a major health care program 

designed to improve the management 

and integration of DoD’s health care 

delivery system. The program’s goal is 

to increase access to health care 

services, improve health care quality, 

and control health care costs. 

The TRICARE Management Activity 

has published or plans to publish the 

following rules: 

• Final rule on CHAMPUS/TRICARE: 

Inclusion of TRICARE Retail 

Pharmacy Program in Federal 

Procurement of Pharmaceuticals. This 

rule provided an additional 

opportunity for comment on the final 

rule of March 17, 2009, implementing 

provisions of section 703 of the 

National Defense Authorization Act 

for Fiscal Year 2008. This statute 

extended pharmaceutical Federal 

Ceiling Prices to TRICARE Retail 

Pharmacy Program prescriptions. The 

Department of Defense (DoD) issued a 

final rule on March 17, 2009, 

implementing the law. On November 

30, 2009, the U.S. District Court for 

the District of Columbia ‘‘ordered that 

the final rule is remanded without 

vacatur for the Defense Department to 

consider in its discretion whether to 

readopt the current iteration of the 

rule or adopt another approach to 

implement 10 U.S.C. 1074g(f).’’ As 

part of DoD’s reconsideration, DoD 

solicited public comments on the 

implementation of the statute, DoD’s 

resulting regulations, and the matters 

addressed for DoD’s consideration in 

the Court’s Memorandum Opinion. 

The proposed rule was published 

February 9, 2010 (75 FR 6335-6336). 

The comment period ended on March 

11, 2010. DoD anticipates publishing 

a second final rule in the first quarter 

of FY 2011. 

• Final rule on TRICARE: Relationship 

Between the TRICARE Program and 

Employer-Sponsored Group Health 

Coverage. This rule implements 

section 1097c of title 10, United States 

Code. This law prohibits employers 

from offering incentives to TRICAREeligible employees to not enroll, or to 

terminate enrollment, in an employeroffered Group Health Plan (GHP) that 

is or would be primary to TRICARE. 

Cafeteria plans that comport with 

section 125 of the Internal Revenue 

Code will be permissible so long as 

the plan treats all employees the same 

and does not illegally take TRICARE 

eligibility into account. The proposed 

rule was published March 28, 2008 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79507 

(73 FR 16612). The comment period 

ended May 27, 2008. The final rule 

published April 9, 2010 (75 FR 18051 

to 18055) with an effective date of 

June 18, 2010. 

• Proposed rule on TRICARE: Sole 

Community Hospital Payment 

Reform. This rule implements the 

statutory provision in section 

1079(j)(2) of title 10, United States 

Code that TRICARE payment methods 

for institutional care shall be 

determined to the extent practicable 

in accordance with the same 

reimbursement rules as those that 

apply to payments to providers of 

services of the same type under 

Medicare. This proposed rule 

implements a reimbursement 

methodology similar to that furnished 

to Medicare beneficiaries for services 

provided by sole community 

hospitals. DoD anticipates publishing 

a proposed rule in the first or second 

quarter of FY 2011. 

• Proposed rule on TRICARE: Long 

Term Care Hospital Prospective 

Payment System. This rule adopts a 

reimbursement methodology for Long 

Term Care Hospitals similar to 

Medicare’s Long Term Care Hospital 

Prospective Payment System. DoD 

anticipates publishing a proposed rule 

in the spring of FY 2011. 

8. Networks and Information 

Integration, Department of Defense 

The Department of Defense will 

publish a rule regarding Defense 

Industrial Base Voluntary Cyber 

Security and Information Assurance 

Information Sharing: 

• Interim Final Rule: This rule 

establishes cyber threat information 

sharing, reporting, and analysis 

mechanisms between DoD and 

cleared Defense Industrial Base (DIB) 

contractors to enhance cyber threat 

situational awareness and threat 

response. The rule establishes a 

voluntary information sharing 

environment with DIB partners to 

address the unacceptable risk and 

imminent threat to national and 

economic security stemming from the 

unauthorized access by U.S. 

adversaries or business competitors to 

critical DoD unclassified information 

resident on, or transiting, DIB 

unclassified networks. The rule 

describes the collaborative DoD and 

DIB corporate-level partnership to 

enhance security of DIB networks; 

increase USG and industry knowledge 

of advanced cyber threats; provide 

near-real time cyber threat 

information sharing and understand 

the impact of data compromise on 

DoD operational activities. 

Participation in the DIB Cyber 

Security/Information Assurance 

program is voluntary and open to all 

qualified cleared contractors. DoD 

anticipates publishing an interim final 

rule in the second quarter of FY 2011. 

DOD—Office of the Secretary (OS) 

FINAL RULE STAGE 

31. VOLUNTARY EDUCATION 

PROGRAMS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

10 USC 2005; 10 USC 2007 

CFR Citation: 

32 CFR 68 

Legal Deadline: 

None 

Abstract: 

This rule implements policy, assigns 

responsibilities, and prescribes 

procedures for the operation of 

voluntary education programs within 

DoD. Included are: Procedures for 

Service members participating in 

education programs; guidelines for 

establishing, maintaining, and operating 

voluntary education programs, 

including but not limited to, instructorled courses offered on-installation and 

off-installation, as well as via distance 

learning; procedures for obtaining onbase voluntary education programs and 

services; minimum criteria for selecting 

institutions to deliver higher education 

programs and services on military 

installations; the establishment of a 

DoD Voluntary Education Partnership 

Memorandum of Understanding 

between DoD and educational 

institutions receiving tuition assistance 

payments; and procedures for other 

education programs for Service 

members and their adult family 

members. 

Statement of Need: 

This rule implements policy, assigns 

responsibilities, and prescribes 

procedures for the operation of 

voluntary education programs within 

DoD. Included are: Procedures for 

Service members participating in 

education programs; guidelines for 

establishing, maintaining, and operating 

voluntary education programs, 

including but not limited to, instructorled courses offered on-installation and 

off-installation, as well as via distance 

learning; procedures for obtaining onbase voluntary education programs and 

services; minimum criteria for selecting 

institutions to deliver higher education 

programs and services on military 

installations; the establishment of a 

DoD Voluntary Education Partnership 

Memorandum of Understanding 

between DoD and educational 

institutions receiving tuition assistance 

payments; and procedures for other 

education programs for Service 

members and their adult family 

members. 

Summary of Legal Basis: 

sections 2005 and 2007 of title 10, 

United States Code 

Alternatives: 

None. 

Anticipated Cost and Benefits: 

Voluntary Education Programs include: 

High School Completion /Diploma; 

Military Tuition Assistance (TA); 

Postsecondary Degree Programs; 

Independent Study and Distance 

Learning Programs; College Credit 

Examination Program; Academic Skills 

Program; and Certification/Licensure 

Programs. Funding for Voluntary 

Education Programs during 2009 was 

$800 million, which included tuition 

assistance and operational costs. This 

funding provided more than 650,000 

individuals (Service members and their 

adult family members) the opportunity 

to participate in Voluntary Education 

Programs around the world. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 08/06/10 75 FR 47504 

NPRM Comment 

Period End 

10/05/10 

Final Action 04/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79508 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Agency Contact: 

Kerrie Tucker 

Department of Defense 

Office of the Secretary 

Defense Pentagon 

Washington, DC 20301 

Phone: 703 602–4949 

RIN: 0790–AI50 

DOD—Office of Assistant Secretary 

for Health Affairs (DODOASHA) 

PROPOSED RULE STAGE 

32. ∑ TRICARE; REIMBURSEMENT OF 

SOLE COMMUNITY HOSPITALS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

5 USC 301; 10 USC ch 55 

CFR Citation: 

32 CFR 199 

Legal Deadline: 

None 

Abstract: 

This proposed rule is to implement the 

statutory provision at 10 U.S.C. 

1079(j)(2) that TRICARE payment 

methods for institutional care be 

determined, to the extent practicable, 

in accordance with the same 

reimbursement rules as those that apply 

to payments to providers of services of 

the same type under Medicare. This 

proposed rule implements a 

reimbursement methodology similar to 

that furnished to Medicare beneficiaries 

for inpatient services provided by Sole 

Community Hospitals (SCHs). It will be 

phased in over a several-year period. 

Statement of Need: 

This rule is being published to 

implement the statutory provision in 10 

U.S.C. 1079(j)(2), that TRICARE 

payment methods for institutional care 

be determined, to the extent 

practicable, in accordance with the 

same reimbursement rules as apply to 

payments to providers of services of the 

same type under Medicare. This 

proposed rule implements a 

reimbursement methodology similar to 

that furnished to Medicare beneficiaries 

for inpatient services provided by Sole 

Community Hospitals. 

Summary of Legal Basis: 

There is a statutory basis for this 

proposed rule: 10 U.S.C. 1079(j)(2). 

Alternatives: 

Alternatives were considered for 

phasing in the needed reform and an 

alternative was selected for a gradual, 

smooth transition. 

Anticipated Cost and Benefits: 

We estimate the total reduction (from 

the proposed changes in this rule) in 

hospital revenues under the SCH 

reform for its first year of 

implementation (assumed for purposes 

of this RIA to be FY 2011), compared 

to expenditures in that same period 

without the proposed SCH changes, to 

be approximately $190 million. The 

estimated impact for FYs 2012 through 

2015 (in $ millions) is $208, $229, 

$252, and $278 respectively. 

Risks: 

Failure to publish this proposed rule 

would result in noncompliance with a 

statutory provision. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Organizations 

Government Levels Affected: 

None 

Agency Contact: 

Marty Maxey 

Department of Defense 

Office of Assistant Secretary for Health 

Affairs 

1200 Defense Pentagon 

Washington, DC 20301 

Phone: 303 676–3627 

RIN: 0720–AB41 

BILLING CODE 5001–06–S 


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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79509 

DEPARTMENT OF EDUCATION (ED) 

Statement of Regulatory Priorities 

I. Introduction 

The U.S. Department of Education 

(Department) supports States, local 

communities, institutions of higher 

education, and others in improving 

education nationwide and in helping to 

ensure that all Americans receive a 

quality education. We provide 

leadership and financial assistance for 

education at all levels to a wide range 

of stakeholders and individuals, 

including State educational agencies, 

local school districts, early learning 

programs, elementary and secondary 

schools, institutions of higher 

education, vocational schools, not-forprofit organizations, members of the 

public, and many others. These efforts 

are helping to ensure that all students 

will be ready for college and careers, 

and that all students have the 

opportunity to attend postsecondary 

education. 

We also vigorously monitor and 

enforce the implementation of Federal 

civil rights laws in educational 

programs and activities that receive 

Federal financial assistance, and 

support innovation and research, 

evaluation, technical assistance, and 

dissemination of research findings to 

improve the quality of education. 

Overall, the programs we administer 

will affect nearly every American during 

his or her life. Indeed, in the 2010 to 

2011 school year, more than 1.5 million 

children, ages birth through 5 years, will 

participate in early learning programs 

under the Individuals with Disabilities 

Education Act (IDEA) and title I of the 

Elementary and Secondary Education 

Act of 1965, as amended (ESEA); about 

50 million students will attend an 

estimated 99,000 elementary and 

secondary schools in approximately 

13,800 public school districts; and about 

20 million students will enroll in 

degree-granting postsecondary schools. 

All of these students may benefit from 

some degree of financial assistance or 

support from the Department. 

In developing and implementing 

regulations, guidance, technical 

assistance, and approaches to 

compliance related to our programs, we 

are committed to working closely with 

affected persons and groups. 

Specifically, we work with a broad 

range of interested parties and the 

general public, including parents, 

students, and educators; other Federal 

agencies and State, local, and tribal 

governments; and neighborhood groups, 

schools, colleges, rehabilitation service 

providers, professional associations, 

advocacy organizations, communitybased organizations, businesses, and 

labor organizations. 

We also continue to seek greater and 

more useful public participation in our 

rulemaking activities through the use of 

transparent and interactive rulemaking 

procedures and new technologies. If we 

determine that it is necessary to develop 

regulations, we seek public 

participation at the key stages in the 

rulemaking process. We invite the 

public to submit comments on all 

proposed regulations through the 

Internet or by regular mail. 

To facilitate the public’s involvement, 

we participate in the Federal Docketing 

Management System (FDMS), an 

electronic single Governmentwide 

access point (www.regulations.gov) that 

enables the public to submit comments 

on different types of Federal regulatory 

documents and read and respond to 

comments submitted by other members 

of the public during the public comment 

period. This system provides the public 

the opportunity to submit a comment 

electronically on any notice of proposed 

rulemaking or interim final regulations 

open for comment, as well as read and 

print any supporting regulatory 

documents. 

We are continuing to streamline 

information collections, reduce the 

burden on information providers 

involved in our programs, and make 

information easily accessible to the 

public. 

II. Regulatory Priorities 

A. American Recovery and 

Reinvestment Act of 2009 

On February 17, 2009, President 

Obama signed into law the American 

Recovery and Reinvestment Act of 2009 

(ARRA), historic legislation designed to 

stimulate the economy, support job 

creation, and invest in critical sectors, 

including education. The ARRA lays the 

foundation for education reform by 

supporting investments in innovative 

strategies that are most likely to lead to 

improved results for children and 

youth, long-term gains in school and 

school system capacity, and increased 

productivity and effectiveness. 

The ARRA provided funding for 

several key discretionary grant 

programs, including the Race to the Top 

Fund and the Investing in Innovation 

Fund. The Department issued 

regulations for these programs in 2009 

and 2010. To the extent Congress 

reauthorizes and appropriates funds for 

these programs in FY 2011, we may 

need to amend the regulations for these 

programs. 

B. Elementary and Secondary Education 

Act of 1965, as Amended 

On March 13, 2010, the Obama 

administration released the Blueprint 

for Reform: The Reauthorization of the 

Elementary and Secondary Education 

Act, the President’s plan for revising the 

ESEA. The blueprint can be found at the 

following Web site: 

http://www2.ed.gov/policy/elsec/leg/ 

blueprint/index.html. 

We look forward to congressional 

reauthorization of the ESEA that will 

build on many of the reforms States and 

LEAs will be implementing under the 

ARRA grant programs described in this 

statement of regulatory priorities. As 

necessary, we intend to amend current 

regulations to reflect the reauthorization 

of this statute. In the interim, we may 

propose other amendments to the 

current regulations. 

C. Higher Education Act of 1965, as 

Amended 

In early 2011, the Department plans to 

issue final regulations to establish 

measures for determining whether 

certain postsecondary educational 

programs lead to gainful employment in 

a recognized occupation. These 

regulations also address the conditions 

under which these educational 

programs remain eligible for the student 

financial assistance programs 

authorized under title IV of the Higher 

Education Act of 1965, as amended 

(HEA). 

On March 30, 2010, the President 

signed into law the Health Care and 

Education Reconciliation Act of 2010, 

Public Law 111-152, title II of which is 

the SAFRA Act. SAFRA made a number 

of changes to the Federal student 

financial aid programs under title IV of 

the HEA. One of the most significant 

changes made by SAFRA is to end new 

loans under the Federal Family 

Education Loan (FFEL) Program 

authorized by title IV, part B, of the 

HEA as of July 1, 2010. 

During the coming year, we plan to 

amend our regulations to address issues 

related to the termination of the FFEL 

Program and the Department’s 

origination of all new loans under the 

William D. Ford Direct Loan Program, as 

well as other statutory provisions 

enacted under SAFRA. Unless subject to 

an exemption, regulations to reflect 

changes to the student financial aid 

programs under title IV of the HEA must 


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generally go through the negotiated 

rulemaking process. 

D. Individuals with Disabilities 

Education Act 

We plan to issue final regulations 

implementing changes to the part C 

program—the early intervention 

program for infants and toddlers with 

disabilities—under the IDEA. 

E. Family Educational Rights and 

Privacy Act 

Given the President’s emphasis on 

improving the collection and use of data 

as a key element of educational reform, 

we intend to issue a notice of proposed 

rulemaking to amend our current 

regulations for the Family Educational 

Rights and Privacy Act of 1974 (FERPA) 

to ensure that States are able to 

effectively establish and expand robust 

statewide longitudinal data systems 

while protecting student privacy. 

F. Other Potential Regulatory Activities 

Congress may legislate to reauthorize 

the Adult Education and Family 

Literacy Act (AEFLA) (title II of the 

Workforce Investment Act of 1998) and 

the Rehabilitation Act of 1973, as 

amended. The Administration is 

working with Congress to ensure that 

any changes to these laws (1) improve 

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 (2) 

provide greater accountability in the 

administration of programs under both 

statutes. Changes to our regulations may 

be necessary as a result of the 

reauthorization of these two statutes. 

III. Principles for Regulating 

Over the next year, other regulations 

may be needed because of new 

legislation or programmatic changes. In 

developing and promulgating 

regulations, we follow our Principles for 

Regulating, which 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 

regulations or with limited regulatory 

action. 

In deciding when to regulate, we 

consider the following: 

• Whether regulations are essential to 

promote quality and equality of 

opportunity in education. 

• Whether a demonstrated problem 

cannot be resolved without 

regulation. 

• Whether regulations are necessary to 

provide a legally binding 

interpretation to resolve ambiguity. 

• Whether entities or situations subject 

to regulation are so diverse that a 

uniform approach through regulation 

does more harm than good. 

• Whether regulations are needed to 

protect the Federal interest; that is, to 

ensure that Federal funds are used for 

their intended purpose and to 

eliminate fraud, waste, and abuse. 

In deciding how to regulate, we are 

mindful of the following principles: 

• Regulate no more than necessary. 

• Minimize burden to the extent 

possible and promote multiple 

approaches to meeting statutory 

requirements if possible. 

• Encourage coordination of federally 

funded activities with State and local 

reform activities. 

• Ensure that the benefits justify the 

costs of regulation. 

• To the extent possible, establish 

performance objectives rather than 

specify compliance behavior. 

• Encourage flexibility, to the extent 

possible, so institutional forces and 

incentives achieve desired results. 

ED—Office of Postsecondary 

Education (OPE) 

PROPOSED RULE STAGE 

33. ∑ TITLE IV OF THE HIGHER 

EDUCATION ACT OF 1965, AS 

AMENDED 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

20 USC title IV; PL 111–152 

CFR Citation: 

34 CFR ch VI 

Legal Deadline: 

None 

Abstract: 

The Secretary proposes to amend its 

title IV, HEA student assistance 

regulations, to (1) reflect the 

termination of the Federal Family 

Education Loan Program pursuant to 

title II of the Health Care and Education 

Reconciliation Act of 2010, which is 

the SAFRA Act, and (2) reflect other 

statutory changes resulting from the 

SAFRA Act. 

Statement of Need: 

These regulations are needed to reflect 

the provisions of the SAFRA Act (title 

II of the Health Care and Education 

Reconciliation Act of 2010), which 

terminated the Federal Family 

Education Loan (FFEL) program, and to 

reflect other amendments to the HEA 

resulting from the SAFRA Act. 

Summary of Legal Basis: 

Health Care and Education 

Reconciliation Act of 2010, Public Law 

111-152. 

Alternatives: 

The Department is still developing 

these proposed regulations; our 

discussion of alternatives will be 

included in the notice of proposed 

rulemaking. 

Anticipated Cost and Benefits: 

Estimates of the costs and benefits are 

currently under development and will 

be published in the proposed 

regulations. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 05/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

None 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

David Bergeron 

Department of Education 

Office of Postsecondary Education 

Room 8022 

1990 K Street NW. 

Washington, DC 20006 

Phone: 202 502–7815 

Email: david.bergeron@ed.gov 

RIN: 1840–AD05 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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ED—OPE 

FINAL RULE STAGE 

34. ∑ PROGRAM INTEGRITY: GAINFUL 

EMPLOYMENT—MEASURES 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

20 USC 1001 to 1003; 20 USC 1070g; 

20 USC 1085; 20 USC 1088; 20 USC 

1091 to 1092; 20 USC 1094; 20 USC 

1099c; 20 USC 1099c–1; . . . 

CFR Citation: 

34 CFR 668 

Legal Deadline: 

None 

Abstract: 

The Secretary amends the Student 

Assistance General Provisions to 

establish measures for determining 

whether certain postsecondary 

educational programs lead to gainful 

employment in recognized occupations, 

and the conditions under which those 

educational programs remain eligible 

for the student financial assistance 

programs authorized under title IV of 

the Higher Education Act of 1965, as 

amended. 

Statement of Need: 

These regulations are needed to 

establish measures for determining 

whether certain postsecondary 

educational programs lead to gainful 

employment in a recognized 

occupation. 

Summary of Legal Basis: 

Title IV of the Higher Education Act 

of 1965, as amended. 

Alternatives: 

A discussion of alternatives was 

outlined in the Notice of Proposed 

Rulemaking published on July 26, 2010. 

Anticipated Cost and Benefits: 

Estimates of anticipated costs and 

benefits are set forth in the Notice of 

Proposed Rulemaking published on 

July 26, 2010. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 07/26/10 75 FR 43616 

NPRM Comment 

Period End 

09/09/10 

Final Action 02/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Organizations 

Government Levels Affected: 

None 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

John A. Kolotos 

Department of Education 

Office of Postsecondary Education 

Room 8018 

1990 K Street NW. 

Washington, DC 20006–8502 

Phone: 202 502–7762 

Email: john.kolotos@ed.gov 

Fred Sellers 

Department of Education 

Office of Postsecondary Education 

Room 8021 

1990 K Street NW. 

Washington, DC 20006 

Phone: 202 502–7502 

Email: fred.sellers@ed.gov 

Related RIN: Previously reported as 

1840–AD04 

RIN: 1840–AD06 

BILLING CODE 4000–01–S 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79512 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

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, energy efficiency, 

environmental remediation, and energy 

research. The Department’s mission is 

to: 

• Promote dependable, affordable, and 

environmentally sound production 

and distribution of energy; 

• Advance energy efficiency and 

conservation; 

• Provide responsible stewardship of 

the Nation’s nuclear weapons; 

• Provide a responsible resolution to 

the environmental legacy of nuclear 

weapons production; 

• Strengthen U.S. scientific discovery, 

economic competitiveness, and 

improving quality of life through 

innovations in science and 

technology. 

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 fulfill the Department’s 

commitment to meeting deadlines for 

issuance of energy conservation 

standards and related test procedures. 

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 

The Energy Policy and Conservation 

Act (EPCA) requires DOE to set 

appliance efficiency standards at levels 

that achieve the maximum improvement 

in energy efficiency that is 

technologically feasible and 

economically justified. The standards 

already published in 2010 have a net 

benefit to the Nation of between $7.7 

billion (7 percent discount rate) and 

23.5 billion (3 percent discount rate) 

over 30 years. By 2045, these standards 

will have saved enough energy to 

operate all U.S. homes for 4 months. 

The Department continues to follow 

its schedule for setting new appliance 

efficiency standards. These rulemakings 

are expected to save American 

consumers billions of dollars in energy 

costs. The 5-year plan to implement the 

schedule outlines how DOE will address 

the appliance standards rulemaking 

backlog and meet the statutory 

requirements established in EPCA and 

the Energy Policy Act of 2005 (EPACT 

2005). The 5-year plan, which was 

developed considering the public 

comments received on the appliance 

standards program, provides for the 

issuance of one rulemaking for each of 

the 22 products in the backlog. The plan 

also provides for setting appliance 

standards for products required under 

EPACT 2005. 

The overall plan for implementing the 

schedule is contained in the Report to 

Congress under section 141 of EPACT 

2005 that was released on January 31, 

2006. This plan was last updated in the 

August 2010 report to Congress and now 

includes the requirements of the Energy 

Independence and Security Act of 2007 

(EISA 2007). The reports to Congress are 

posted at: 

http://www.eere.energy.gov/ 

appliancelstandards/ 

schedulelsetting.html. 

The August 2010 report identifies all 

products for which DOE has missed the 

deadlines established in EPCA (42 

U.S.C. sec. 6291 et seq.). It also 

describes the reasons for such delays 

and the Department’s plan for 

expeditiously prescribing new or 

amended standards. Information and 

timetables concerning these actions can 

also be found in the Department’s 

regulatory agenda, which is posted 

online at: www.reginfo.gov. 

Estimate of Combined Aggregate Costs 

and Benefits 

The regulatory actions included in 

this regulatory plan for residential 

refrigerators and freezers, fluorescent 

lamp ballasts, residential central air 

conditioners and heat pumps, 

residential furnaces, manufactured 

housing, and clothes dryers and room 

air conditioners provide significant 

benefits to the Nation. DOE believes that 

the benefits to the Nation of the 

proposed energy standards for 

residential refrigerators and freezers 

(energy savings, consumer average lifecycle cost savings, national net present 

value increase, and emissions 

reductions) outweigh the costs (loss of 

industry net present value and life-cycle 

cost increases for some consumers). 

DOE estimates that these refrigerator 

and freezer regulations will produce an 

energy savings of 4.5 quads over 30 

years. The benefit to the Nation will be 

between $2.44 billion (7 percent 

discount rate) and $18.57 billion (3 

percent discount rate). DOE believes 

that the proposed energy standards for 

fluorescent lamp ballasts, central air 

conditioners and heat pumps, 

residential furnaces, manufactured 

housing, and clothes dryers and room 

air conditioners will also be beneficial 

to the Nation. Because DOE has not yet 

proposed candidate standard levels for 

this equipment, however, DOE cannot 

provide an estimate of combined 

aggregate costs and benefits for these 

actions. DOE will, however, in 

compliance with all applicable law, 

issue standards that will provide the 

maximum energy savings that are 

technologically feasible and 

economically justified. Estimates of 

energy savings will be provided when 

DOE issues the notices of proposed 

rulemaking for this equipment. 

DOE—Energy Efficiency and 

Renewable Energy (EE) 

PROPOSED RULE STAGE 

35. ENERGY EFFICIENCY 

STANDARDS FOR CLOTHES DRYERS 

AND ROOM AIR CONDITIONERS 

Priority: 

Economically Significant. Major status 

under 5 USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

42 USC 6295(c) and (g) 

CFR Citation: 

10 CFR 430 

Legal Deadline: 

Final, Judicial, June 30, 2011. 

Abstract: 

The Energy Policy and Conservation 

Act, as amended, establishes initial 

energy efficiency standard levels for 

many types of major residential 

appliances and generally requires DOE 

to undertake two subsequent 

rulemakings, at specified times, to 

determine whether the existing 

standard for a covered product should 

be amended. This is the second review 

of the standards for clothes dryers and 

room air conditioners. 


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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79513 

Statement of Need: 

The Energy Policy and Conservation 

Act requires minimum energy 

efficiency standards for appliances, 

which has the effect of eliminating 

inefficient appliances from the market. 

Summary of Legal Basis: 

Title III of EPCA sets forth a variety 

of provisions designed to improve 

energy efficiency. Part A of title III (42 

U.S.C. 6291 to 6309) provides for the 

Energy Conservation Program for 

Consumer Products other than 

Automobiles. EPCA covers consumer 

products and certain commercial 

equipment, including clothes dryers 

and room are conditioners that are the 

subject of the rulemaking (42 U.S.C. 

6292(a)(2)-(8)). EPCA prescribes energy 

conservation standards for room air 

conditioners (42 U.S.C. 6295(c)) and 

directs DOE to conduct two cycles of 

rulemaking to determine whether to 

adopt amended standards (42 U.S.C. 

6295(c)(3)(A)). For clothes dryers, EPCA 

sets a prescriptive requirement (42 

U.S.C. 6294(g)(3)) and directs DOE to 

conduct a cycle of rulemaking to 

determine whether to adopt amended 

standards (42 U.S.C. 6294(g)(4)). This 

rulemaking represents the second and 

first round of amendments to the 

standards for room air conditioners and 

dryers respectively. 

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 a technologically feasible and 

economically justified. In making this 

determination, DOE conducts a 

thorough analysis of the alternative 

standard levels, including the existing 

standard, based on the criteria specified 

by the statute. 

Anticipated Cost and Benefits: 

Because DOE has not yet proposed 

candidate standard levels for these 

products, DOE cannot provide an 

estimate of combine aggregate costs and 

benefits for these actions. DOE will, 

however, in compliance with all 

applicable law, issue standards that 

provide the maximum energy savings 

that are technologically feasibly and 

economically justified. Estimates of 

energy savings will be provided when 

DOE issues the notices of proposed 

rulemaking for this equipment. 

Timetable: 

Action Date FR Cite 

Notice: Public 

Meeting, 

Framework 

Document 

Availability 

10/09/07 72 FR 57254 

Notice: Public 

Meeting, Data 

Availability 

02/23/10 75 FR 7987 

Comment Period End 04/26/10 

NPRM 03/00/11 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Local, State 

Federalism: 

Undetermined 

Additional Information: 

This rulemaking is the second of two 

rulemakings required for this 

equipment. Comments pertaining to 

this rule may be submitted 

electronically to aham2-2008-TP0010@hq.doe.gov. 

URL For More Information: 

www1.eere.energy.gov/ 

buildingslstandards/residential/ 

clothesldryers.html 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Stephen Witkowski 

Office of Building Technologies Program, 

EE–2J 

Department of Energy 

Energy Efficiency and Renewable Energy 

1000 Independence Avenue SW. 

Washington, DC 20585 

Phone: 202 586–7463 

Email: stephen.witkowski@ee.doe.gov 

Related RIN: Merged with 1904–AB51, 

Related to 1904–AB76, Related to 

1904–AC02 

RIN: 1904–AA89 

DOE—EE 

36. ENERGY EFFICIENCY 

STANDARDS FOR RESIDENTIAL 

CENTRAL AIR CONDITIONERS AND 

HEAT PUMPS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

42 USC 6295(d) 

CFR Citation: 

10 CFR 430 

Legal Deadline: 

Final, Judicial, June 30, 2011. 

Abstract: 

DOE is reviewing and updating energy 

efficiency standards, as required by the 

Energy Policy and Conservation Act, to 

reflect technological advances. All 

amended standards must be 

technologically feasible and 

economically justified. This is the 

second review of the statutory 

standards for residential central air 

conditioners and air conditioning heat 

pumps. 

Statement of Need: 

The Energy Policy and Conservation 

Act requires minimum energy 

efficiency standards for appliances, 

which has the effect of eliminating 

inefficient appliances and equipment 

from the market. 

Summary of Legal Basis: 

Title III of EPCA sets forth a variety 

of provisions designed to improve 

energy efficiency. Part A of title III (42 

U.S.C. 6291 to 6309) provides for the 

Energy Conservation Program for 

Consumer Products other than 

Automobiles. Amendments expanded 

title III of EPCA to include certain 

commercial and industrial equipment. 

(42 U.S.C. 6292(3)) The National 

Appliance Energy Conservation Act of 

1987 (NAECA), Pub. L. 100—12, 

established energy conservation 

standards for central air conditioners 

and heat pumps as well as 

requirements for determining whether 

these standards should be amended. 

NAECA also required that DOE conduct 

two cycles of rulemakings to determine 

if more stringent standards are 

economically justified and 

technologically feasible. (42 U.S.C. 

6295(d)(3)) On January 22, 2001, DOE 

published a final rule in the Federal 

Register, which completed the first 

rulemaking cycle to amend energy 

conservation standards for residential 

central air conditioners and heat 

pumps. 66 FR 7170. This rulemaking 

encompasses DOE’s second cycle of 

review to determine whether the 

standards in effect for residential 

central air conditioners and heat pumps 

should be amended. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79514 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

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, DOE conducts a 

thorough analysis of the alternative 

standard levels, including the existing 

standard, based on the criteria specified 

by the statute. 

Anticipated Cost and Benefits: 

Because DOE has not yet proposed 

candidate standard levels for this 

equipment, DOE cannot provide an 

estimate of combined aggregate costs 

and benefits for these actions. DOE 

will, however, in compliance with all 

applicable law, issue standards that 

provide the maximum energy savings 

that are technologically feasible and 

economically justified. Estimates of 

energy savings will be provided when 

DOE issues the notices of proposed 

rulemaking for this equipment. 

Timetable: 

Action Date FR Cite 

Notice: Public 

Meeting, 

Framework 

Document 

Availability 

06/06/08 73 FR 32243 

Notice: Public 

Meetings, Data 

Availability 

03/25/10 75 FR 14368 

NPRM 12/00/10 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Local, State 

Federalism: 

Undetermined 

Additional Information: 

This rulemaking is the second of two 

rulemakings required for this 

equipment. Comments pertaining to 

this rule may be submitted 

electronically to 

ReslCentrallAClHP@ee.doe.gov. 

URL For More Information: 

www1.eere.energy.gov/buildings/ 

appliancelstandards/residential/ 

centrallaclhp.html 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Wes Anderson 

Mechanical Engineer, Office of Building 

Technologies Program, EE–2J 

Department of Energy 

Energy Efficiency and Renewable Energy 

1000 Independence Avenue SW. 

Washington, DC 20585 

Phone: 202 586–7335 

Email: wes.anderson@ee.doe.gov 

Related RIN: Related to 1904–AB94 

RIN: 1904–AB47 

DOE—EE 

37. ENERGY EFFICIENCY 

STANDARDS FOR FLUORESCENT 

LAMP BALLASTS 

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, Judicial, June 30, 2011. 

Abstract: 

DOE is reviewing and updating energy 

efficiency standards, as required by the 

Energy Policy and Conservation Act, to 

reflect technological advances. All 

amended energy efficiency standards 

must be technologically feasible and 

economically justified. This is the 

second review of the statutory 

standards for fluorescent lamp ballasts. 

Statement of Need: 

The Energy Policy and Conservation 

Act requires minimum energy 

efficiency standards for appliances, 

which has the effect of eliminating 

inefficient appliances and equipment 

from the market. 

Summary of Legal Basis: 

The Energy Policy and Conservation 

Act (EPCA) of 1975 (42 U.S.C. 6291 to 

6309) established an energy 

conservation program for major 

household appliances. Amendments to 

EPCA in the National Appliance Energy 

Conservation Amendments of 1988 

(NAECA 1988) established energy 

conservation standards for fluorescent 

lamp ballasts. These amendments also 

required that DOE (1) conduct two 

rulemaking cycles to determine 

whether these standards should be 

amended and (2), for each rulemaking 

cycle, determine whether the standards 

in effect for fluorescent lamp ballasts 

should be amended to apply to 

additional fluorescent lamp ballasts. (42 

U.S.C. 6295(g)(7)(A)—(B)). On 

September 19, 2000, DOE published a 

final rule in the Federal Register, which 

completed the first rulemaking cycle to 

amend energy conservation standards 

for fluorescent lamp ballasts. 65 FR 

56740. This rulemaking encompasses 

DOE’s second cycle of review to 

determine whether the standards in 

effect for fluorescent lamp ballasts 

should be amended and whether the 

standards should be applicable to 

additional fluorescent lamp ballasts. 

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, DOE conducts a 

thorough analysis of the alternative 

standard levels, including the existing 

standard, based on the criteria specified 

by the statute. 

Anticipated Cost and Benefits: 

Because DOE has not yet proposed 

candidate standard levels for this 

equipment, however, DOE cannot 

provide an estimate of combined 

aggregate costs and benefits for these 

actions. DOE will, however, in 

compliance with all applicable law, 

issue standards that provide the 

maximum energy savings that are 

technologically feasible and 

economically justified. Estimates of 

energy savings will be provided when 

DOE issues the notices of proposed 

rulemaking for this equipment. 

Timetable: 

Action Date FR Cite 

Notice: Public 

Meeting, 

Framework 

Document 

Availability 

01/22/08 73 FR 3653 

Notice: Public 

Meetings, Data 

Availability 

03/24/10 75 FR 14319 

NPRM 12/00/10 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Local, State 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79515 

Federalism: 

Undetermined 

Additional Information: 

This rulemaking is the second of two 

rulemakings required for this 

equipment. Comments pertaining to 

this rule may be submitted 

electronically to 

ballasts.rulemaking@ee.doe.gov. 

URL For More Information: 

www1.eere.energy.gov/ 

buildings/appliancelstandards/ 

residential. 

fluorescentllamp.ballasts.html 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Linda Graves 

Office of Building Technologies Program, 

EE–2J 

Department of Energy 

Energy Efficiency and Renewable Energy 

1000 Independence Avenue SW. 

Washington, DC 20585 

Phone: 202 586–1851 

Email: linda.graves@ee.doe.gov 

Related RIN: Related to 1904–AB77, 

Related to 1904–AA99 

RIN: 1904–AB50 

DOE—EE 

38. ENERGY EFFICIENCY 

STANDARDS FOR RESIDENTIAL 

FURNACES 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

42 USC 6295(f) and (m) 

CFR Citation: 

10 CFR 430 

Legal Deadline: 

Final, Judicial, June 30, 2011. 

Abstract: 

DOE published an energy conservation 

standard final rule for residential 

furnaces and boilers in the Federal 

Register on November 19, 2007 (72 FR 

65136). Petitioners challenged this final 

rule on several grounds. DOE filed a 

motion for voluntary remand to allow 

the agency to consider: 1) The 

application of regional standards in 

additional to national standards for 

furnaces, authorized by Energy 

Independence and Security Act of 2007 

(enacted Dec. 19, 2007) and 2) the 

effect of alternative standards on 

natural gas prices. This motion for 

voluntary remand was granted on April 

21, 2009. DOE has initiated this 

rulemaking to consider amended energy 

conservation standards for residential 

furnaces. 

Statement of Need: 

The Energy Policy and Conservation 

Act requires minimum energy 

efficiency standards for appliances, 

which has the effect of eliminating 

inefficient appliances and equipment 

from the market. 

Summary of Legal Basis: 

Title III of EPCA sets forth a variety 

of provisions designed to improve 

energy efficiency. Part A of title III (42 

U.S.C. 6291 to 6309) provides for the 

Energy Conservation Program for 

Consumer Products other than 

Automobiles. The program covers 

certain commercial and industrial 

equipment, including residential 

furnaces. (42 U.S.C. 6292(a)(5)) EPCA 

prescribed the initial energy 

conservation standards for residential 

furnaces. (42 U.S.C. 6295(f)(1)—(2)) The 

statute further provides DOE with the 

authority to conduct rulemakings to 

determine whether to amend these 

standards. (42 U.S.C. 6295(f)(4)). 

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, DOE conducts a 

thorough analysis of the alternative 

standard levels, including the existing 

standard, based on the criteria specified 

by the statute. 

Anticipated Cost and Benefits: 

Because DOE has not yet proposed 

candidate standard levels for this 

equipment, DOE cannot provide an 

estimate of combined aggregate costs 

and benefits for these actions. DOE 

will, however, in compliance with all 

applicable law, issue standards that 

provide the maximum energy savings 

that are technologically feasible and 

economically justified. Estimates of 

energy savings will be provided when 

DOE issues the notices of proposed 

rulemaking for this equipment. 

Timetable: 

Action Date FR Cite 

Notice: Public 

Meeting, 

Rulemaking 

Analysis Plan 

Availability 

03/15/10 75 FR 12144 

NPRM 12/00/10 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

URL For More Information: 

http://www1.eere.energy.gov/buildings/ 

appliancelstandards/residential/ 

furnaceslboilers.html 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Mohammed Khan 

Office of Building Technologies Program, 

EE–2J 

Department of Energy 

Energy Efficiency and Renewable Energy 

1000 Independence Avenue SW. 

Washington, DC 20585 

Phone: 202 586–7892 

Email: mohammed.khan@ee.doe.gov 

RIN: 1904–AC06 

DOE—EE 

39. ENERGY EFFICIENCY 

STANDARDS FOR MANUFACTURED 

HOUSING 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

42 USC 17071 

CFR Citation: 

10 CFR 460 

Legal Deadline: 

Final, Statutory, December 19, 2011. 

Abstract: 

The rule would establish energy 

efficiency standards for manufactured 

housing and a system to ensure 

compliance with, and enforcement of, 

the standards. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79516 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Statement of Need: 

The Energy Independence and Security 

Act requires increased energy efficiency 

standards for manufactured housing. 

Summary of Legal Basis: 

Section 413 of the Energy 

Independence and Security Act of 2007 

(EISA), 42 U.S.C. 17071 directs DOE to 

develop and publish energy standards 

for manufactured housing. 

Alternatives: 

The statute requires DOE to conduct a 

rulemaking to establish standards to 

achieve the maximum improvement in 

energy efficiency that the Secretary 

determines is technologically feasible 

and economically justified. In making 

this determination, DOE conducts a 

thorough analysis of the alternative 

standard levels, including the existing 

standard, based on the criteria specified 

by the statute. 

Anticipated Cost and Benefits: 

Because DOE has not yet proposed 

candidate standard levels, DOE cannot 

provide an estimate of combined 

aggregate costs and benefits for these 

actions. DOE will, however, in 

compliance with all applicable law, 

issue standards that provide the 

increased energy savings that are 

technologically feasible and 

economically justified. Estimates of 

energy savings will be provided when 

DOE issues the notice of proposed 

rulemaking. 

Timetable: 

Action Date FR Cite 

ANPRM 02/22/10 75 FR 7556 

ANPRM Comment 

Period End 

03/24/10 

NPRM 04/00/11 

Final Action 12/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

None 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Jean J. Boulin 

Project Manager, Office of Building 

Technologies Program, EE–2J 

Department of Energy 

Energy Efficiency and Renewable Energy 

1000 Independence Avenue SW. 

Washington, DC 20585 

Phone: 202 586–9870 

Email: jean.boulin@ee.doe.gov 

RIN: 1904–AC11 

DOE—EE 

FINAL RULE STAGE 

40. ENERGY EFFICIENCY 

STANDARDS FOR RESIDENTIAL 

REFRIGERATORS, 

REFRIGERATOR–FREEZERS, AND 

FREEZERS 

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(b)(4) 

CFR Citation: 

10 CFR 430 

Legal Deadline: 

Final, Statutory, December 31, 2010. 

Abstract: 

The Energy Independence and Security 

Act of 2007 amended the Energy Policy 

and Conservation Act and directed the 

Secretary to issue a final rule to 

determine whether to amend the 

standards for refrigerators, refrigeratorfreezers, and freezers. The final rule 

will contain any amended standards. 

Statement of Need: 

The Energy Policy and Conservation 

Act requires minimum energy 

efficiency standards for appliances, 

which has the effect of eliminating 

inefficient appliances and equipment 

from the market. 

Summary of Legal Basis: 

Title III of EPCA sets forth a variety 

of provisions designed to improve 

energy efficiency. Part A of title III (42 

U.S.C. 6291 to 6309) provides for the 

Energy Conservation Program for 

Consumer Products other than 

Automobiles. EPCA covers consumer 

products and certain commercial 

equipment, including the types of 

refrigeration products that are the 

subject of this rulemaking. (42 U.S.C. 

6292(a)(1)) EPCA prescribes energy 

conservation standards for these 

products (42 U.S.C. 6295(b)(1)-(2)) and 

directs DOE to conduct three cycles of 

rulemakings to determine whether to 

adopt amended standards. (42 U.S.C. 

6295(b)(3)(A)(i), (b)(3)(B)-(C), and (b)(4)) 

This rulemaking represents the third 

round of amendments to the standards 

for refrigeration products. 

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, DOE conducts a 

thorough analysis of the alternative 

standard levels, including the existing 

standard, based on the criteria specified 

by the statute 

Anticipated Cost and Benefits: 

DOE believes that the benefits to the 

Nation of the proposed energy 

standards for residential refrigerators 

and freezers (energy savings, consumer 

average lifecycle cost (LCC) savings, 

national net present value (NPV) 

increase, and emission reductions) 

outweigh the burdens (loss of INPV and 

LCC increases for some small electric 

motor users). DOE estimates that energy 

savings from electricity will be 4.5 

quads over 30 years and the benefit to 

the Nation will be between $2.56 

billion and $18.80 billion. 

Timetable: 

Action Date FR Cite 

Notice: Public 

Meeting, 

Framework 

Document 

Availability 

09/18/08 73 FR 54089 

Notice: Public 

Meeting, Data 

Availability 

11/16/09 74 FR 58915 

NPRM 09/27/10 75 FR 59470 

NPRM Comment 

Period End 

11/26/10 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Local, State 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79517 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Additional Information: 

Comments pertaining to this rule may 

be submitted electronically to 

ResRefFreez-2008-STD0012@hq.doe.gov. 

URL For More Information: 

www.eere.energy.gov/buildings/ 

appliancelstandards/residential/ 

refrigeratorslfreezer.html 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Subid Wagley 

Office of Building Technologies Program, 

EE–2J 

Department of Energy 

Energy Efficiency and Renewable Energy 

1000 Independence Avenue SW. 

Washington, DC 20585 

Phone: 202 287–1414 

Email: subid.wagley@ee.doe.gov 

Related RIN: Related to 1904–AB92 

RIN: 1904–AB79 

BILLING CODE 6450–01–S 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79518 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Statement of Regulatory Priorities for 

FY 2011 

The Department of Health and Human 

Services (HHS) is the Federal 

Government’s principal agency charged 

with protecting the health of all 

Americans and providing essential 

human services. HHS’ responsibilities 

include: Medicare, Medicaid, support 

for public health preparedness and 

emergency response, biomedical 

research, substance abuse and mental 

health treatment and prevention, 

assurance of safe and effective drugs 

and other medical products, protection 

of our Nation’s food supply, assistance 

to low-income families, the Head Start 

program, services to older Americans, 

and direct health services delivery. 

Significantly, the Congress tasked HHS 

as the primary Department to 

implement the Affordable Care Act of 

2010. 

These programs constitute a 

substantial portion of the priorities of 

the Federal Government, and as such, 

the HHS budget represents almost a 

quarter of all Federal outlays, and the 

Department administers more grant 

dollars than all other agencies 

combined. Significantly, the Congress 

tasked HHS as the primary Department 

to implement the Affordable Care Act of 

2010. The Department has met the 

statutory deadlines related to the key 

provisions of this law through the 

issuance of regulations, bulletins, and 

other guidance documents. The 

principle objective of the Department 

will continue to be implementation of 

the Affordable Care Act in a manner that 

promotes consumer protections, 

improves quality and safety, 

incentivizes more efficient care 

delivery, and slows the growth of health 

care costs. These policies reflect the 

Department’s commitment to put 

consumers first, to provide stability in 

private insurance markets, and reform 

the health care delivery system. 

Since assuming the leadership of HHS 

last year, Secretary Kathleen G. Sebelius 

has sought to prioritize efforts to 

promote early childhood health and 

development, help Americans achieve 

and maintain healthy weight, prevent 

and reduce tobacco use, protect the 

health and safety of Americans in public 

health emergencies, accelerate the 

process of scientific discovery to 

improve patient care, implement a 21st 

century food safety system, and ensure 

program integrity and responsible 

stewardship. Further, the Secretary has 

worked devotedly to enact meaningful 

reform of the country’s health care 

system, and the Department has and 

will continue to focus considerable 

effort on implementation of the 

landmark health care reform bill passed 

by the Congress and signed into law by 

President Obama in March of 2010. 

The Obama Administration has 

prioritized the use of rulemaking to 

promote open government and to 

identify regulatory approaches that 

maximize net benefits. HHS regulatory 

priorities in the upcoming fiscal year 

reflect these goals in two ways. First, 

they advance transparency through the 

use of disclosure as a regulatory tool. 

Second, they maximize the net benefits 

conferred on society by utilizing 

rigorous cost-benefit analyses in the 

development of regulations. Below is an 

overview of the Department’s regulatory 

priorities for FY 2011 that best 

exemplify these objectives. 

Promotion of Open Government 

1. Transparency for Consumers Under 

the Affordable Care Act 

Two regulations to be promulgated by 

the Department in FY 2011 will require 

that insurers submit certain information 

on how they pay claims and set their 

premiums. One of these regulations will 

require certain statistics and 

information on claims, rating processes, 

and cost sharing to be disclosed to the 

State and Federal Government, as well 

as to consumers. HHS estimates the 

benefits of this regulation to come from 

improved information for consumers 

and regulators, which will in turn result 

in a more efficient insurance market. 

Improved information for consumers 

will allow them to make better health 

insurance choices—to choose higher 

quality insurers and ones that more 

closely match their preferences with 

respect to plan design. This could result 

in increased satisfaction and decreased 

morbidity. In addition, consumers may 

be more likely to choose insurers with 

more efficient processes, which could 

result in a reduction in administrative 

costs. Improved information for 

regulators will allow for monitoring of 

the markets to track current industry 

practices, which will allow for better 

enforcement of current market 

regulations through more targeted audits 

that are based upon insurer responses. 

Additionally, reporting requirements 

and the threat of targeted audits will 

likely influence issuer behavior to 

motivate compliance. It is not possible 

to quantify the benefits at this time. The 

direct costs imposed by the regulation 

are the reporting requirements. These 

requirements are still being developed, 

and will be quantified in the regulation. 

The other regulation will ensure that 

all insurers use a uniform, easily 

understood format for accurate 

summaries of benefits and coverage 

explanations. Together, these two 

regulations will improve availability of 

meaningful information about health 

insurance to consumers, enabling them 

to better assess the coverage they 

currently have and/or make choices 

among different coverage options. HHS 

estimates the benefits of this regulation 

to come from improved information for 

consumers and regulators, which will in 

turn result in a more efficient insurance 

market. Improved information for 

consumers will allow them to make 

better health insurance choices—to 

choose higher quality insurers and ones 

that more closely match their 

preferences with respect to plan design. 

This could result in increased 

satisfaction and decreased morbidity. It 

is not possible to quantify the benefits 

at this time. The direct costs imposed by 

the regulation are the creation and 

provision of summary documents to 

consumers at the time of application, 

prior to enrollment and at reenrollment. 

There will also be costs imposed by the 

creation of the coverage facts label 

section of the summary documents. 

These requirements are still being 

developed and will be quantified in the 

regulation. 

2. Public Health and Nutrition 

Three rules to be promulgated by the 

FDA in the upcoming fiscal year will 

propose new labeling requirements 

aimed at better disclosing to the public 

critical information to enable them to 

make informed decisions about food 

and drugs that they choose to consume. 

One proposed rule will require color 

graphics on cigarette packages depicting 

the health consequences of smoking. 

The largest benefits of this proposed 

rule stem from increased life 

expectancies for individuals who are 

induced not to smoke. Other 

quantifiable benefits come from 

reductions in cases of non-fatal 

emphysema, reductions in fire losses, 

and reductions in medical expenditures. 

Unquantifiable benefits come from 

reductions in smokers’ non-fatal 

illnesses other than emphysema, 

reductions in passive smoking, and 

reductions in infant and child health 

effects due to mothers’ smoking during 

pregnancy. Large, one-time costs will 

arise from the need to change cigarette 

package labels and remove point-of-sale 

promotions that do not comply with the 

new advertising restrictions. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79519 

Additionally, there will be smaller 

ongoing FDA enforcement costs. 

Two other key rules will implement 

provisions of the Affordable Care Act 

that require certain chain restaurants 

and vending machine operators to 

disclose nutritional information about 

their offerings. In the case of chain 

restaurants, these businesses will bear 

the cost of analysis of their menu items 

for nutritional information where this 

analysis does not already exist, and the 

cost of revising existing menus and 

other displays to note the required 

information. In the case of vending 

machines, the bulk of the costs 

associated with this rule will be in 

managing the actual disclosure of 

calories at the machine. Because almost 

all vending machines sell food that is 

previously manufactured and packaged, 

most vended foods are subject to the 

Nutrition Labeling and Education Act, 

which means that calorie content is 

already collected. The requirements of 

these rules, specifically that calorie and 

other nutrition information appear at 

the point of purchase, solves the 

apparent market failure in information 

provision stemming from present-biased 

preferences. 

3. Enhanced Insurance Appeal and 

External Review Processes Under the 

Affordable Care Act 

With a goal of empowering patient 

consumers, the Affordable Care Act 

provides individuals with the right to 

appeal decisions made by their private 

health insurer to an outside, 

independent decisionmaker, regardless 

of consumers’ State of residence or type 

of health insurance. One rule to be 

promulgated by the Department in FY 

2011 will ensure that non-grandfathered 

plans and issuers comply with State or 

Federal external review processes. This 

rule will advance the Administration’s 

objective of transparency by making 

certain that all consumers—regardless of 

whether their plan has grandfather 

status—are afforded an opportunity to 

appeal the decisions of their health 

carrier before an independent body. 

HHS estimates the benefits of the 

regulation to come from the 

transformation of the current, highly 

variable health claims and appeals 

process into a more uniform and 

structured process. This will result in a 

reduction in the incidence of excessive 

delays and inappropriate denials, 

averting serious, avoidable lapses in 

health care quality and resultant injuries 

and losses to participants; enhance 

enrollees’ level of confidence in and 

satisfaction with their health care 

benefits and improve plans’ awareness 

of participant concerns, prompting plan 

responses that improve quality; helping 

ensure prompt and precise adherence to 

contract terms and improving the flow 

of information between plans and 

enrollees to bolster the efficiency of 

labor, health care, and insurance 

markets. It is not possible to quantify 

these benefits at this time. The primary 

sources of costs are those required to 

administer and conduct the internal and 

external review process, prepare and 

distribute required disclosures and 

notices, and bring plan and issuers’ 

internal and external claims and appeals 

procedures into compliance with the 

new requirements. In addition, there are 

start-up costs for issuers in the 

individual market to bring themselves 

into compliance and the costs and 

transfers associated with the reversal of 

denied claims. These costs are estimated 

to total $50.4 million in 2011, $78.8 

million in 2012, and $101.1 million in 

2013. 

4. Notification Requirements for LongTerm Care Facility Closures 

A rule to be promulgated by CMS in 

the upcoming fiscal year will require 

that, in the case of a long-term care 

facility closure, the facility 

administrator provides written 

notification of closure and the plan for 

the relocation of residents at least 60 

days prior to the impending closing. 

Such transparency will afford patients 

and family members a greater 

opportunity to meaningfully participate 

in decisions regarding relocation. The 

costs associated with the 

implementation of this rule are related 

to the efforts made by each facility to 

develop a plan for closure. The benefits 

would include the protection of 

residents’ health and safety and a 

smooth transition for residents who 

need to be relocated, as well as their 

family members and facility staff. 

In addition to the aforementioned 

rules, the Department’s regulatory 

priorities in the upcoming fiscal year 

include: 

Eliminating Insurance Company Abuses 

Under the Affordable Care Act 

The Affordable Care Act made 

important changes that will improve the 

affordability and transparency of private 

health insurance in the United States. 

Specifically, the law calls for the annual 

State review of unreasonable increases 

in health insurance premiums, which 

will help protect consumers from 

unjustified and/or excessive premium 

increases. In developing a process for 

the review of rate increases, HHS will 

propose standards for when and how 

health insurance issuers will be 

required to report rate increases, as well 

as detail the relevant data and 

documentation that must be submitted 

in support of rate increases. The 

proposed rule will detail criteria for 

how determinations of 

unreasonableness will be made by HHS 

and also sets forth the conditions under 

which HHS will adopt 

unreasonableness determinations made 

by States. The rule will also propose 

standards for when and how health 

insurance issuers must provide 

justifications for rate increases 

determined to be unreasonable and 

when such justifications must be posted 

on the issuer’s website. It will explain 

that HHS will post information 

regarding rate increases on its website to 

ensure the public disclosure of 

information on rate increases, including 

increases determined to be 

unreasonable. Finally, the proposed rule 

will address the development by HHS of 

annual summaries of data on rate 

trends. 

The CLASS Act and Improving LongTerm Care 

The Department will promulgate a 

significant rule in FY 2011 that will 

improve the quality of long-term care for 

affected Americans. Implementation of 

the CLASS (Community Living 

Assistance Services and Support) Act 

will provide a new opportunity for all 

Americans to prepare themselves 

financially to remain independent 

under a variety of future health 

circumstances as they age. While this 

program may help reduce spending 

down to Medicaid, costs to implement 

the proposed regulation have not yet 

been estimated. 

Food Safety 

The Department is committed to 

improvements in our food safety system 

guided in part by the findings of the 

President’s Food Safety Working Group, 

which adopted a public-health approach 

based on three core principles: 

Prioritizing prevention, strengthening 

surveillance and enforcement, and 

improving response and recovery if 

prevention fails. The goal of this new 

agenda is to shift emphasis away from 

mitigating public health harm by 

removing unsafe products from the 

market place to a new overriding 

objective—preventing harm by keeping 

unsafe food from entering commerce in 

the first place. As such, an FDA 

regulation will aim squarely at 

protecting the youngest and most 

vulnerable Americans by finalizing a 

modernization of existing requirements 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79520 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

on current good manufacturing practices 

for infant formula. 

Streamlining Drug and Device 

Requirements 

Two Food and Drug Administration 

(FDA) final rules will standardize the 

electronic submission of registrations 

and listings for devices, data from 

studies evaluating drugs and biologics 

for humans, and data on adverse events 

involving medical devices. 

Standardization of clinical data 

structure, terminology, and code sets 

will increase the efficiency of the 

Agency review process. FDA estimates 

that the costs resulting from the 

proposal would include substantial onetime costs, additional waves of one-time 

costs as standards mature, and possibly 

some annual recurring costs. One-time 

costs would include, among other 

things, the cost of converting data to 

standard structures, terminology, and 

cost sets (i.e., purchase of software to 

convert data); the cost of submitting 

electronic data (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 associated 

with reduced time for preparing 

applications, including reduced 

preparation costs and faster time to 

market for beneficial products. In 

addition, the proposed rule would 

improve patient safety through faster, 

more efficient, comprehensive, and 

accurate data review, as well as 

enhanced communication among 

sponsors and clinicians. 

Additionally, a new proposed rule 

will establish a unique identification 

system that will identify a device 

through distribution and use. FDA 

estimates that the affected industry 

would incur one-time and recurring 

costs, including administrative costs, to 

change and print labels that include the 

required elements of a unique device 

identifier (UDI), costs to purchase 

equipment to print and verify the UDI, 

and costs to purchase software, integrate 

and validate the UDI into existing IT 

systems. Certain entities would be 

required to submit information about 

each UDI and the relevant medical 

device into a database. FDA anticipates 

that implementation of a UDI system 

would help improve the efficiency of 

recalled medical devices and medical 

device adverse event reporting. The 

proposed rule would also standardize 

how medical devices are identified and 

contribute to future potential public 

health benefits of initiatives aimed at 

optimizing the use of automated 

systems in healthcare. Most of these 

benefits, however, require 

complementary developments and 

innovations in the private and public 

sectors. Together, these rules will enable 

the FDA to more quickly and efficiently 

process and review information 

submitted on devices, drugs, and 

biologics, furthering their ability to both 

better protect the public safety and more 

rapidly advance innovations to the 

market. 

Medicare Modernization 

The Regulatory Plan highlights three 

final rules that would adjust payment 

amounts under Medicare for physicians’ 

services, hospital inpatient, and hospital 

outpatient services for fiscal year 2012. 

These new payment rules reflect 

continuing experience with regulating 

these systems and will implement 

modernizations to ensure that the 

Medicare program best serves its 

beneficiaries, fairly compensates 

providers, and remains fiscally sound. 

Additionally, another rule promulgated 

under the Affordable Care Act will 

propose a Medicare shared savings 

program for provider groups to establish 

Accountable Care Organizations and 

share in savings generated for Medicare 

by meeting certain benchmarks. 

Health Information Technology 

The Department will issue a rule that 

will modify the existing HIPAA privacy 

and security enforcement regulations to 

comply with the provisions of the 

HITECH Act. This rule will ensure that 

Americans can be confident that their 

medical data is kept private as the 

country increasingly moves to electronic 

health records. These modifications to 

the HIPAA Privacy, Security, and 

Enforcement Rules will benefit health 

care consumers by strengthening the 

privacy and security protections 

afforded their health information by 

HIPAA covered entities and their 

business associates. The Agency 

believes the primary cost associated 

with this regulation will be for covered 

entities to revise and redistribute their 

notices of privacy practices to ensure 

health care consumers are informed of 

their new rights and protections. The 

Agency estimates the cost of revising 

and redistributing these notices to total 

approximately $166.1 million over the 

first year following the effective date of 

the regulation. Of this total, the cost to 

health care providers is estimated to be 

approximately $46 million and to health 

plans to be approximately $120.1 

million. The Agency does not believe 

that the additional modifications to the 

Privacy, Security, or Enforcement Rules 

required by this regulation will 

significantly increase covered entity or 

business associate costs. It is estimated 

that the changes to the HIPAA 

authorization and access requirements 

will impose little to no additional costs 

on covered entities and their business 

associates, and in some cases will 

reduce burden. Further, it is expected 

that the costs of modifying business 

associate contracts will be mitigated 

both by the additional one-year 

transition period which will allow the 

costs of modifying contracts to be 

incorporated into the normal 

renegotiation of contracts as the 

contracts expire, as well as sample 

business associate contract language to 

be provided by the Agency. 

Head Start Program Integrity 

The Department will finalize a rule in 

FY 2011 that will implement statutory 

requirements requiring a re-evaluation 

of Head Start grantees every 5 years to 

ensure that taxpayer dollars are spent in 

the most effective possible manner by 

this critical program. The 

Administration on Children and 

Families estimates the costs of 

implementing the new reporting 

requirements described in the rule will 

be approximately $20,000 annually. In 

addition, at least 25 percent of grantees 

reviewed in a year will be required to 

submit a competitive application for a 

new 5-year grant, at an estimated cost of 

less than $1,500 for each grantee. In 

terms of benefits, the proposed system 

will fund only high-performing grantees 

in order to ensure the best services for 

Head Start children are provided and 

child outcomes are improved. 

Small Business Impact 

Finally, HHS actively seeks to 

minimize regulatory burdens on small 

business. Over 95 per cent of the entities 

that we regulate – hospitals, doctors’ 

practices, social service providers, 

medical device firms, universities and 

many others – qualify as ‘‘small 

entities’’ under the Regulatory 

Flexibility Act (RFA). All of the 

aforementioned actions have been 

developed in light of and with serious 

consideration of the small-business 

impact analysis. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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HHS—Office of the Secretary (OS) 

FINAL RULE STAGE 

41. MODIFICATIONS TO THE HIPAA 

PRIVACY, SECURITY, AND 

ENFORCEMENT RULES UNDER THE 

HEALTH INFORMATION 

TECHNOLOGY FOR ECONOMIC AND 

CLINICAL HEALTH ACT 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

PL 111–5, secs 13400 to 13410 

CFR Citation: 

45 CFR 160; 45 CFR 164 

Legal Deadline: 

NPRM, Statutory, February 17, 2010. 

Abstract: 

The Department of Health and Human 

Services Office for Civil Rights will 

issue rules to modify the HIPAA 

Privacy, Security, and Enforcement 

Rules as necessary to implement the 

privacy, security, and certain 

enforcement provisions of subtitle D of 

the Health Information Technology for 

Economic and Clinical Health Act (title 

XIII of the American Recovery and 

Reinvestment Act of 2009). 

Statement of Need: 

The Office for Civil Rights will issue 

rules to modify the HIPAA Privacy, 

Security, and Enforcement Rules to 

implement the privacy and security 

provisions in sections 13400 to 13410 

of the Health Information Technology 

for Economic and Clinical Health Act 

(title XIII of Division A of the American 

Recovery and Reinvestment Act of 

2009, Pub. L. 111-5). These regulations 

will improve the privacy and security 

protection of health information. 

Summary of Legal Basis: 

Subtitle D of the Health Information 

Technology for Economic and Clinical 

Health Act (title XIII of the American 

Recovery and Reinvestment Act of 

2009) requires the Office for Civil 

Rights to modify certain provisions of 

the HIPAA Privacy and Security Rules 

to implement sections 13400 to 13410 

of the Act. 

Alternatives: 

The Office for Civil Rights is statutorily 

mandated to make modifications to the 

HIPAA Privacy and Security Rules to 

implement the privacy provisions at 

sections 13400 to 13410 of the Health 

Information Technology for Economic 

and Clinical Health Act (title XIII of 

the American Recovery and 

Reinvestment Act of 2009). 

Anticipated Cost and Benefits: 

These modifications to the HIPAA 

Privacy, Security, and Enforcement 

Rules will benefit health care 

consumers by strengthening the privacy 

and security protections afforded their 

health information by HIPAA covered 

entities and their business associated. 

The Agency believe the primary cost 

associate with this regulation will be 

for covered entities to revise and 

redistribute their notices of privacy 

practices to ensure health care 

consumers are informed of their new 

rights and protections. The Agency 

estimates the cost of revising and 

redistributing these notices to total 

approximates $166.1 million over the 

first year following the effective date 

of the regulation. Of this total, the cost 

heal care providers is estimated to be 

approximately $46 million and to 

health plans to be approximately 

$120.1 million. The Agency does not 

believe that the additional modification 

to Privacy, Security, or Enforcement 

Rules required by this regulation will 

significantly increase covered entity or 

business associates and in some cases 

will reduce burden. Further, it is 

expected that the costs of modifying 

business associate contracts will be 

mitigated both by the additional oneyear transition period which will allow 

the costs of modifying contracts to be 

incorporated into the normal 

renegotiation of contracts as the 

contracts expire, as well as sample 

business associate contract language to 

be provided by the Agency. 

Timetable: 

Action Date FR Cite 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions, 

Organizations 

Government Levels Affected: 

Federal, Local, State, Tribal 

Agency Contact: 

Andra Wicks 

Department of Health and Human 

Services 

200 Independence Avenue SW. 

Washington, DC 20201 

Phone: 202 205–2292 

Fax: 202 205–4786 

Email: andra.wicks@hhs.gov 

RIN: 0991–AB57 

HHS—Office of Consumer Information 

and Insurance Oversight (OCIIO) 

PROPOSED RULE STAGE 

42. ∑ TRANSPARENCY REPORTING 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

PL 111–148, title I, subtitle A, sec 1001 

PHS Act, sec 2715A 

CFR Citation: 

45 CFR 153, Insurance Rules (sec 

2715A) 

Legal Deadline: 

None 

Abstract: 

The Affordable Care Act requires group 

health plans and health insurance 

issuers to submit specific information 

to the Secretary, the State insurance 

commissioner, and to make the 

information available to the public. 

This includes information on claims 

payment policies, the number of claims 

denied, data on rating practices and 

other information as determined by the 

Secretary. The provision also requires 

plans and issuers to provide to 

individuals upon request the amount of 

cost sharing that the individual would 

be responsible for paying for a specific 

item or service provided by a 

participating provider. This interim 

final rule would implement information 

disclosure provisions in section 2715A 

of the Public Health Service Act, as 

added by the Affordable Care Act. 

Statement of Need: 

The Department of Health and Human 

Services, along with the Department of 

Labor and the Treasury Department, 

will issue interim final rules to 

implement the information disclosure 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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provisions in section 2715A of the 

Public Health Service Act, as added by 

the Affordable Care Act. This regulation 

will improve the transparency of 

information about how health coverage 

works so consumers will have better 

information to use and assess the 

coverage they have now, and/or make 

choices among different coverage 

options. 

Summary of Legal Basis: 

Title I, subtitle A, section 1001 of the 

Affordable Care Act adds section 2715A 

to the Public Health Service Act that 

will require group health plans and 

health insurance issuers to make 

certain disclosures to the Secretary, the 

State insurance commissioner, the 

public, and in some cases, individuals. 

Alternatives: 

None—statutory requirement. 

Anticipated Cost and Benefits: 

HHS estimates the benefits of this 

regulation to come from improved 

information for consumers and 

regulators, which will in tern result in 

a more efficient insurance market. 

Improved information for consumers 

will allow them to make better health 

insurance choices — to choose higher 

quality insurers and ones that more 

closely match their preferences with 

respect to plan design. This could 

result in increased satisfaction and 

decreased morbidity. In addition, 

consumers may be more likely to 

choose insurers with more efficient 

processes, which could result in a 

reduction in administrative costs. 

Improved information for regulators 

will allow for monitoring of the 

markets to track current industry 

practices, which will allow for better 

enforcement of current market 

regulations through more targeted 

audits that are based upon insurer 

responses. Additionally, reporting 

requirements and the threat of targeted 

audit will likely influence issuer 

behavior to motivate compliance. I is 

not possible to quantify the benefits at 

this time. 

The direct costs imposed by the 

regulation are reporting requirements. 

These requirements are still being 

developed, and will be quantified in 

the regulation. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Kaye L. Pestaina 

Office of Consumer Support 

Department of Health and Human 

Services 

Office of Consumer Information and 

Insurance Oversight 

200 Independence Avenue SW. 

Washington, DC 20201 

Phone: 301 492–4227 

Email: kaye.pestaina@hhs.gov 

RIN: 0950–AA07 

HHS—OCIIO 

FINAL RULE STAGE 

43. ∑ RATE REVIEW 

Priority: 

Other Significant. Major under 5 USC 

801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

PL 111–148 

CFR Citation: 

45 CFR 154 

Legal Deadline: 

None 

Abstract: 

The Affordable Care Act requires the 

Secretary to work with states to 

establish an annual review of 

unreasonable rate increases, to monitor 

premium increases and to award grants 

to states to carry out their rate review 

process. This interim final rule would 

implement the rate review process. 

Statement of Need: 

The Affordable Care Act requires 

standards to be set for the review of 

rate increases. The proposed rule will 

detail standards for when and how 

health insurance issuers will be 

required to report rate increases, as 

well as detail the relevant data and 

documentation that must be submitted 

in support of the rate increases. The 

proposed rule will detail criteria for 

how determinations of 

unreasonableness will be made by 

HHS, and also sets forth the conditions 

under which HHS will adopt 

unreasonableness determinations made 

by States. This regulation is part of the 

health insurance market reform and 

will increase affordability of health 

insurance for all Americans. 

Summary of Legal Basis: 

The Affordable Care Act. 

Alternatives: 

There are no alternatives, as this 

rulemaking is a matter of law based on 

the Affordable Care Act. 

Anticipated Cost and Benefits: 

HHS expects that costs associated with 

this rulemaking will be minimal as 

insurers routinely report to States on 

rate increases. Insurers may experience 

slight additional costs in connection 

with completion of policy rate data 

collection forms and any necessary 

submission of justification forms for 

rates that trigger unreasonable 

designations. The benefits of these 

requirements include increased 

consumer protections around 

unsubstantiated premium rate 

increases, reduced health insurance rate 

increases, increased transparency and 

consumer confidence in the products 

they buy, and ensuring financially 

solvent companies that can pay 

promised benefits. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 07/03/10 75 FR 45014 

Interim Final Rule 

Comment Period 

End 

09/28/10 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

James Mayhew 

Department of Health and Human 

Services 

Office of Consumer Information and 

Insurance Oversight 

Mail Stop C2–12016 

7500 Security Boulevard 

Baltimore, MD 21244 

Phone: 410 786–9244 

Email: james.mayhew@cms.hhs.gov 

RIN: 0950–AA03 


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HHS—OCIIO 

44. ∑ UNIFORM EXPLANATION OF 

BENEFITS, COVERAGE FACTS, AND 

STANDARDIZED DEFINITIONS 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

PL 111–148, title I, subtitle A, sec 1001 

(Public Health Service Act, sec 2715) 

CFR Citation: 

45 CFR 153, Insurance Rules (sec 2715) 

Legal Deadline: 

None 

Abstract: 

The Affordable Care Act requires the 

Secretary to develop standards for use 

by group health plans and health 

insurance issuers in compiling and 

providing a summary of benefits and 

coverage explanation that accurately 

describes benefits and coverage. The 

Secretary must also set standards for 

the definitions of terms used in health 

insurance coverage, including specific 

terms set out in the statute. Plans and 

issuers must provide information 

according to these standards no later 

than 24 months after enactment. This 

interim final rule would implement the 

information disclosure provisions in 

section 2715 of PHSA , as added by 

the Affordable Care Act. 

Statement of Need: 

The Department of Health and Human 

Services, along with the Departments of 

Labor and the Treasury, will issue 

interim final rules to implement the 

information disclosure provisions in 

section 2715 of PHSA, as added by the 

Affordable Care Act. This regulation 

will provide consumers with a 

simplified and uniform overview of 

their benefits, specific ‘‘Coverage Facts’’ 

or scenarios for the costs of coverage 

for specific episodes of care, and 

standardized consumer-friendly health 

coverage definitions. This will allow 

consumers to better understand the 

coverage that they have and allow 

consumers choosing coverage to better 

compare coverage options. 

Summary of Legal Basis: 

Title I, subtitle A, section 1001, of the 

Affordable Care Act adds section 2715 

to the Public Health Service Act that 

will require group health plans and 

health insurance issuers to provide a 

summary of benefits and coverage 

explanations and standardized 

definitions to applicants, enrollees, and 

policyholders. 

Alternatives: 

None—statutory requirement. 

Anticipated Cost and Benefits: 

HHS estimates the benefits of this 

regulation to come from improved 

information for consumers and 

regulators, which will in turn result in 

a more efficient insurance market. 

Improved information for consumers 

will allow them to make better health 

insurance choices—to chose higher 

quality insurers and ones that more 

closely match their preference with 

respect to plan design. This could 

result in increased satisfaction and 

decreased morbidity. It is not possible 

to quantify the benefits at this time. 

The direct costs imposed by the 

regulation are the creation and 

provision of summary documents to 

consumers at the time of application, 

prior to enrollment and at reenrollment. There will also be costs 

imposed by the creation of the coverage 

facts label section of the summary 

documents. These requirements are still 

being developed and will be quantified 

in the regulation. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Kaye L. Pestaina 

Office of Consumer Support 

Department of Health and Human 

Services 

Office of Consumer Information and 

Insurance Oversight 

200 Independence Avenue SW. 

Washington, DC 20201 

Phone: 301 492–4227 

Email: kaye.pestaina@hhs.gov 

RIN: 0950–AA08 

HHS—Food and Drug Administration 

(FDA) 

PROPOSED RULE STAGE 

45. ELECTRONIC SUBMISSION OF 

DATA FROM STUDIES EVALUATING 

HUMAN DRUGS AND BIOLOGICS 

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 355; 21 USC 371; 42 USC 262 

CFR Citation: 

21 CFR 314.50; 21 CFR 601.12; 21 CFR 

314.94; 21 CFR 314.96 

Legal Deadline: 

None 

Abstract: 

The Food and Drug Administration is 

proposing to amend the regulations 

governing the format in which clinical 

study data and bioequivalence data 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 data submitted for 

NDAs, BLAs, and ANDAs, and their 

supplements and amendments, be 

provided in an electronic format that 

FDA can process, review, and archive. 

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 and 

bioequivalence data that are submitted 

as part of the marketing application. 

Study data submitted to FDA in 

electronic format have generally been 

more efficient to process and review. 

FDA’s proposed rule would address the 

submission of study data in a 

standardized electronic format. 

Electronic submission of study data 

would improve patient safety and 

enhance health care delivery by 

enabling FDA to process, review, and 

archive data more efficiently. 

Standardization would also enhance 

the ability to share study data and 

communicate results. Investigators and 

industry would benefit from the use of 


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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 clinical study data and 

bioequivalence data 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 

study data, but not requiring electronic 

submission of the data 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 2-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 

savings to industry would be small. 

Anticipated Cost and Benefits: 

Standardization of clinical data 

structure, terminology, and code sets 

will increase the efficiency of the 

Agency review process. FDA estimates 

that the costs resulting from the 

proposal would include substantial 

one-time costs, additional waves of 

one-time costs as standards mature, and 

possibly some annual recurring costs. 

One-time costs would include, among 

other things, the cost of converting data 

to standard structures, terminology, and 

cost sets (i.e., purchase of software to 

convert data); the cost of submitting 

electronic data (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 

associated with reduced time for 

preparing applications, including 

reduced preparation costs and faster 

time to market for beneficial products. 

In addition, the proposed rule would 

improve patient safety through faster, 

more efficient, comprehensive and 

accurate data review, as well as 

enhanced communication among 

sponsors and clinicians. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/11 

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 

WO 51, Room 6352 

10903 New Hampshire Avenue 

Silver Spring, MD 20993–0002 

Phone: 301 796–3471 

Fax: 301 847–8440 

Email: martha.nguyen@fda.hhs.gov 

RIN: 0910–AC52 

HHS—FDA 

46. UNIQUE DEVICE IDENTIFICATION 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

15 USC 1451 to 1461; 21 USC 141 to 

149, 321 to 394, 467f, 679, 821, 1034; 

28 USC 2112; 42 USC 201 to 262, 263a 

and 263b, 264, 271, 364 

CFR Citation: 

21 CFR 16, 801, 803, 806, 810, 814, 

820, 821, 

Legal Deadline: 

None 

Abstract: 

The Food and Drug Administration 

Amendments Act of 2007, amended the 

Federal Food, Drug, and Cosmetic Act 

by adding section 519(f) (21 U.S.C. 

360i(f)). This section requires FDA to 

promulgate regulations establishing a 

unique identification system for 

medical devices requiring the label of 

medical devices to bear a unique 

identifier, unless FDA specifies an 

alternative placement or provides for 

exceptions. The unique identifier must 

adequately identify the device through 

distribution and use, and may include 

information on the lot or serial number. 

Statement of Need: 

A unique device identification system 

will help reduce medical errors; will 

allow FDA, the healthcare community, 

and industry to more rapidly review 

and organize adverse event reports; 

identify problems relating to a 

particular device (even down to a 

particular lot or batch, range of serial 

numbers, or range of manufacturing or 

expiration dates); and thereby allow for 

more rapid, effective, corrective actions 

that focus sharply on the specific 

devices that are of concern. 

Summary of Legal Basis: 

This rule is provided for/mandated by 

FDAAA. Section 519(f) of the FD&C Act 

(added by sec. 226 of the Food and 

Drug Administration Amendments Act 

of 2007) directs the Secretary to 

promulgate regulations establishing a 

unique device identification (UDI) 

system for medical devices, requiring 

the label of devices to bear a unique 

identifier that will adequately identify 

the device through its distribution and 

use. 

Alternatives: 

FDA considered several alternatives 

that allow certain requirements of the 

proposed rule to vary, such as the 

required elements of a UDI and the 

scope of affected devices. 

Anticipated Cost and Benefits: 

FDA estimates that the affected 

industry would incur one-time and 

recurring costs, including 

administrative costs, to change and 

print labels that include the required 

elements of a UDI, costs to purchase 

equipment to print and verify the UDI, 

and costs to purchase software, 

integrate and validate the UDI into 

existing IT systems. Certain entities 

would be required to submit 

information about each UDI and the 

relevant medical device into a database, 

FDA would incur costs to develop, 


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implement, and administer a database 

that would serve as a repository of 

information to facilitate the 

identification of medical devices 

through their distribution and use. FDA 

anticipates that implementation of a 

UDI system would help improve the 

efficiency of recalled medical devices 

and medical device adverse event 

reporting. The proposed rule would 

also standardize how medical devices 

are identified and contribute to future 

potential public health benefits of 

initiatives aimed at optimizing the use 

of automated systems in healthcare. 

Most of these benefits, however, require 

complementary developments and 

innovations in the private and public 

sectors. 

Risks: 

This rule is intended to substantially 

eliminate existing obstacles to the 

adequate identification of medical 

devices used in the Unites States. By 

providing the means to rapidly and 

definitely identify a device and key 

attributes that affect its safe and 

effective use, the rule would reduce 

medical errors that result from 

misidentification of a device or 

confusion concerning its appropriate 

use. The rule will fulfill a statutory 

directive to establish a unique device 

identification system. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

John J. Crowley 

Senior Advisor for Patient Safety 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Devices and Radiological 

Health 

WO 66, Room 2315 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

Phone: 301 980–1936 

Email: jay.crowley@fda.hhs.gov 

RIN: 0910–AG31 

HHS—FDA 

47. CIGARETTE WARNING LABEL 

STATEMENTS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

PL 111–31, The Family Smoking 

Prevention and Tobacco Control Act, 

sec 201 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

Final, Statutory, June 22, 2011. 

Section 4 of the Federal Cigarette 

Labeling and Advertising Act (FCLAA), 

as amended by section 201 of the 

Family Smoking Prevention and 

Tobacco Control Act (the Tobacco 

Control Act), requires FDA to issue 

regulations no later than 24 months 

after the date of enactment of the 

Tobacco Control Act that require color 

graphics depicting the negative health 

consequences of smoking. 

Abstract: 

Section 4 of the FCLAA, as amended 

by section 201 of the Tobacco Control 

Act, requires FDA to issue regulations 

that require color graphics depicting 

the negative health consequences of 

smoking to accompany required 

warning statements. FDA also may 

adjust the type size, text and format 

of the required label statements on 

product packaging and advertising if 

FDA determines that it is appropriate 

so that both the graphics and the 

accompanying label statements are 

clear, conspicuous, legible and appear 

within the specified area. 

Statement of Need: 

This proposed rule is necessary to 

amend FDA’s regulations to add a new 

requirement for the display of health 

warnings on cigarette packages and in 

cigarette advertisements and to specify 

the color graphics that must accompany 

each textual warning statement. 

Summary of Legal Basis: 

The proposed rule would implement a 

provision of the Tobacco Control Act 

that requires FDA to issue regulations 

requiring color graphics depicting the 

negative health consequences of 

smoking to accompany the nine new 

textual warning statements that will be 

required under the Tobacco Control 

Act. The Tobacco Control Act amends 

the FCLAA to require each cigarette 

package and advertisement to bear one 

of nine new textual warning statements. 

Alternatives: 

The Agency will compare the proposed 

rule to two hypothetical alternatives: 

An otherwise identical rule with a 24- 

month compliance period and an 

otherwise identical rule with a 6-month 

compliance period. Although we will 

compare the rule to two hypothetical 

alternatives, they are not viable 

regulatory options as they are 

inconsistent with FDA’s statutory 

mandate. 

Anticipated Cost and Benefits: 

The largest benefits of this proposed 

rule stem from increased life 

expectancies for individuals who are 

induced not to smoke. Other 

quantifiable benefits come from 

reductions in cases of non-fatal 

emphysema, reductions in fire losses, 

and reductions in medical 

expenditures. Unquantifiable benefits 

come from reductions in smokers’ nonfatal illnesses other than emphysema, 

reductions in passive smoking, and 

reductions in infant and child health 

effects due to mothers’ smoking during 

pregnancy.Large, one-time costs will 

arise from the need to change cigarette 

package labels and remove point-of-sale 

promotions that do not comply with 

the new advertising restrictions. 

Additionally, there will be smaller 

ongoing FDA enforcement costs. 

Risks: 

This proposed rule would reduce the 

risk to the public by helping to clearly 

and effectively convey the negative 

health consequences of smoking on 

cigarette packages and in cigarette 

advertisements, which would help both 

to discourage non-smokers, including 

minor children, from initiating cigarette 


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use and to encourage current smokers 

to consider cessation. 

Timetable: 

Action Date FR Cite 

NPRM 11/12/10 75 FR 69524 

NPRM Comment 

Period End 

01/11/11 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Undetermined 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Gerie Voss 

Regulatory Counsel 

Department of Health and Human 

Services 

Food and Drug Administration 

9200 Corporate Boulevard 

Rockville, MD 20850 

Phone: 877 287–1373 

Fax: 240 276–4193 

Email: gerie.voss@fda.hhs.gov 

RIN: 0910–AG41 

HHS—FDA 

48. ∑ FOOD LABELING: NUTRITION 

LABELING FOR FOOD SOLD IN 

VENDING MACHINES 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

21 USC 343; 21 USC 371 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

NPRM, Statutory, March 23, 2011, 

Proposed rule to be published 1 year 

after enactment. 

Abstract: 

The Food and Drug Administration 

(FDA) is proposing regulations to 

establish requirements for nutrition 

labeling of food sold in vending 

machines. FDA is also proposing the 

terms and conditions for registering to 

voluntarily be subject to the 

requirements of section 4205. FDA is 

taking this action to carry out the 

provisions of section 4205 of the 

Patient Protection and Affordable Care 

Act (‘‘Affordable Care Act’’ or ‘‘ACA’’), 

which was signed into law on March 

23, 2010. 

Statement of Need: 

This proposed rule was mandated by 

section 4205 of the Affordable Care Act. 

Summary of Legal Basis: 

On March 23, 2010, the Affordable Care 

Act (Pub. L. 111-148) was signed into 

law. Section 4205 amended 403(q)(5) of 

the Federal Food, Drug, and Cosmetic 

Act by creating new clause (H) to 

require that vending machine operators, 

who own or operate 20 or more 

machines, disclose calories for food 

items. FDA has the authority to issue 

this proposed rule under section 

403(q)(5)(H) and 701(a) (21 U.S.C. 

343(q)(5)(H), and 371(a)). Section 701(a) 

of the act vests the Secretary (and, by 

delegation, the FDA) with the authority 

to issue regulations for the efficient 

enforcement of the act. 

Alternatives: 

Section 4205 requires the Secretary 

(and, by delegation, the FDA) to 

establish, by regulation, requirements 

for calorie disclosure of food items for 

vending machine operators, who own 

or operate 20 or more machines. 

Therefore, there are no alternatives to 

rulemaking. 

Anticipated Cost and Benefits: 

The bulk of the costs associated with 

this rule will be in managing the actual 

disclosure of calories at the machine. 

Since almost all vending machines sell 

food that is previously manufactured 

and packaged, most vended foods are 

subject to the Nutrition Labeling 

Education Act, which means that 

calorie content is already collected. A 

likely scenario for response to vending 

machine labeling is that food 

manufacturers include a set of calorie 

label stickers in each case of product. 

Since consumers of vended foods do 

not generally have access to nutrition 

information prior to purchase, requiring 

that operators make that information 

available should benefit consumers. 

Consumers may ignore future costs of 

overeating, relative to the current gains 

from eating, even when they 

understand the connection. Therefore, 

consumers do not generally demand 

calorie and other nutrition information 

for food away from home, even when 

they do, given a wider frame of 

reference, value that information. Given 

the costs and the uncertain reception 

for calorie information that many 

consumers appear not to care about, 

most vending machine operators have 

chosen not to display calorie 

information. The requirements of the 

proposed rule, specifically, that calorie 

and other nutrition information appear 

at the point of purchase, solves the 

apparent market failure in providing 

information provision stemming from 

present-biased preferences. 

Risks: 

For some vending machine foods, 

consumers cannot view the nutrition 

facts panel or otherwise see nutrition 

information prior to purchasing the 

item. Completion of this rulemaking 

will provide consumers information 

about the nutritional content of food to 

empower them to make healthier food 

choices from vending machines. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

NPRM Comment 

Period End 

06/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions 

Government Levels Affected: 

Federal, Local, State 

Federalism: 

Undetermined 

Agency Contact: 

Geraldine A. June 

Supervisor, Product Evaluation and 

Labeling Team 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Food Safety and Applied 

Nutrition 

(HFS–820) 

5100 Paint Branch Parkway 

College Park, MD 20740 

Phone: 301 436–1802 

Fax: 301 436–2636 

Email: geraldine.june@fda.hhs.gov 

RIN: 0910–AG56 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79527 

HHS—FDA 

49. ∑ FOOD LABELING: NUTRITION 

LABELING OF STANDARD MENU 

ITEMS IN CHAIN RESTAURANTS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

21 USC 343; 21 USC 371 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

NPRM, Statutory, March 23, 2011, 

Proposed rule to be published 1 year 

after enactment. 

Abstract: 

The Food and Drug Administration 

(FDA) is proposing regulations to 

establish requirements for nutrition 

labeling of standard menu items for 

chain restaurants and similar retail food 

establishments. FDA is also proposing 

the terms and conditions for registering 

to voluntarily be subject to the 

requirements of section 4205. FDA is 

taking this action to carry out the 

provisions of section 4205 of the 

Patient Protection and Affordable Care 

Act (‘‘Affordable Care Act’’ or ‘‘ACA’’), 

which was signed into law on March 

23, 2010. 

Statement of Need: 

This proposed rule was mandated by 

section 4205 of the Affordable Care Act. 

Summary of Legal Basis: 

On March 23, 2010, the Affordable Care 

Act (Pub. L. 111-148) was signed into 

law. Section 4205 amended 403(q)(5) of 

the Federal Food, Drug, and Cosmetic 

Act by creating new clause (H) to 

require that chain restaurants, with 20 

or more locations, require certain 

nutrient disclosure. Specifically, 

section 4205 required the Secretary of 

Health and Human Services to issue a 

proposed regulation to carry out clause 

(H) of the ACA no later than 1 year 

of enactment of this clause (i.e., Mar. 

23, 2011). FDA has the authority to 

issue this proposed rule under section 

403(q)(5)(H) and 701(a) (21 U.S.C. 

343(q)(5)(H), and 371(a)). Section 701(a) 

of the act vests the Secretary (and, by 

delegation, the FDA) with the authority 

to issue regulations for the efficient 

enforcement of the act. 

As directed by section 4205, FDA is 

proposing requirements for menu 

calorie declaration, as well as other 

nutrition information declaration to 

implement the provisions of 

403(q)(5)(H). FDA is also proposing the 

terms and conditions for registering to 

voluntarily be subject to the 

requirements of section 4205. 

Alternatives: 

Section 4205 requires the Secretary 

(and, by delegation, the FDA) to 

establish, by regulation, requirements 

for nutrition labeling of standard menu 

items for chain restaurants and similar 

retail food establishments. Therefore, 

there are no alternatives to rulemaking. 

Anticipated Cost and Benefits: 

Chain restaurants operating in local 

jurisdictions that impose different 

nutrition labeling requirements will 

benefit from having a uniform national 

standard. Any restaurant, with fewer 

than 20 locations, may opt in to the 

national standard to receive this 

benefit. Many chain restaurants, with 

20 or more locations, will bear costs 

for adding nutrition information to 

menus and menu boards. Consumers 

will benefit from having important 

nutrition information for the 

approximately 30 per cent of calories 

consumed away from home. 

Risks: 

Americans now consume an estimated 

one-third of their total calories on foods 

prepared outside the home and spend 

almost half of their food dollars on 

such foods. Unlike packaged foods that 

are labeled with nutrition information, 

foods in restaurants, for the most part, 

do not have nutrition information. 

Completion of this rulemaking will 

provide consumers information about 

the nutritional content of food to 

empower them to make healthier food 

choices. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

NPRM Comment 

Period End 

06/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions 

Government Levels Affected: 

Federal, Local, State 

Federalism: 

Undetermined 

Agency Contact: 

Geraldine A. June 

Supervisor, Product Evaluation and 

Labeling Team 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Food Safety and Applied 

Nutrition 

(HFS–820) 

5100 Paint Branch Parkway 

College Park, MD 20740 

Phone: 301 436–1802 

Fax: 301 436–2636 

Email: geraldine.june@fda.hhs.gov 

RIN: 0910–AG57 

HHS—FDA 

FINAL RULE STAGE 

50. INFANT FORMULA: CURRENT 

GOOD MANUFACTURING 

PRACTICES; QUALITY CONTROL 

PROCEDURES; NOTIFICATION 

REQUIREMENTS; RECORDS AND 

REPORTS; AND QUALITY FACTORS 

Priority: 

Other Significant 

Legal Authority: 

21 USC 321; 21 USC 350a; 21 USC 371; 

. . . 

CFR Citation: 

21 CFR 106 and 107 

Legal Deadline: 

None 

Abstract: 

The Food and Drug Administration 

(FDA) is revising its infant formula 

regulations in 21 CFR parts 106 and 

107 to establish requirements for 

current good manufacturing practices 

(CGMP), including audits; to establish 

requirements for quality factors; and to 

amend FDA’s quality control 

procedures, notification, and record 

and reporting requirements for infant 

formula. FDA is taking this action to 

improve the protection of infants who 

consume infant formula products. 

Statement of Need: 

The agency published a proposed rule 

on July 9, 1996, that would establish 

current good manufacturing practice 

regulations, quality control procedures, 

quality factors, notification 

requirements, records and reports for 

the production of infant formula. This 

proposal was issued in response to the 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79528 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

1986 Amendments to the Infant 

Formula Act of 1980. On April 28, 

2003, FDA reopened the comment 

period to update comments on the 

proposal. The comment was extended 

on June 27, 2003 and ended on August 

26, 2003. The comment period was 

reopened on August 1, 2006 and ended 

on September 15, 2006. 

Summary of Legal Basis: 

The Infant Formula Act of 1980 (the 

1980 Act) (Pub. L. 96-359) amended the 

Federal Food, Drug, and Cosmetic Act 

(the Act) to include section 412 (21 

U.S.C. 350a). This law is intended to 

improve protection of infants 

consuming infant formula products by 

establishing greater regulatory control 

over the formulation and production of 

infant formula. In 1982, FDA adopted 

infant formula recall procedures in 

subpart D of 21 CFR part 107 of its 

regulations (47 FR 18832, Apr. 30, 

1982), and infant formula quality 

control procedures in subpart B of 21 

CFR part 106 (47 FR 17016, Apr. 20, 

1982). In 1985, FDA further 

implemented the 1980 Act by 

establishing subparts B, C, and D in 21 

CFR part 107 regarding the labeling of 

infant formula, exempt infant formulas, 

and nutrient requirements for infant 

formula, respectively (50 FR 1833, Jan. 

14, 1985; 50 FR 48183, Nov. 22, 1985; 

and 50 FR 45106, Oct. 30, 1985). 

In 1986, Congress, as part of the AntiDrug Abuse Act of 1986 (Pub. L. 99- 

570) (the 1986 amendments), amended 

section 412 of the act to address 

concerns that had been expressed by 

Congress and consumers about the 1980 

Act and its implementation related to 

the sufficiency of quality control 

testing, CGMP, recordkeeping, and 

recall requirements. The 1986 

amendments: (1) State that an infant 

formula is deemed to be adulterated if 

it fails to provide certain required 

nutrients, fails to meet quality factor 

requirements established by the 

Secretary (and, by delegation, FDA), or 

if it is not processed in compliance 

with the CGMP and quality control 

procedures established by the 

Secretary; (2) require that the Secretary 

issue regulations establishing 

requirements for quality factors and 

CGMP, including quality control 

procedures; (3) require that infant 

formula manufacturers regularly audit 

their operations to ensure that those 

operations comply with CGMP and 

quality control procedure regulations; 

(4) expand the circumstances in which 

firms must make a submission to the 

Agency to include when there is a 

major change in an infant formula or 

a change that may affect whether the 

formula is adulterated; (5) specify the 

nutrient quality control testing that 

must be done on each batch of infant 

formula; (6) modify the infant formula 

recall requirements; and (7) give the 

Secretary authority to establish 

requirements for retention of records, 

including records necessary to 

demonstrate compliance with CGMP 

and quality control procedures. In 

1989, the Agency implemented the 

provisions on recalls (secs. 412(f) and 

(g) of the act) by establishing subpart 

E in 21 CFR part 107 (54 FR 4006, Jan. 

27, 1989). In 1991, the Agency 

implemented the provisions on record 

and record retention requirements by 

revising 21 CFR 106.100 (56 FR 66566, 

Dec. 24, 1991). 

The Agency has already promulgated 

regulations that respond to a number 

of the provisions of the 1986 

amendments. The final rule would 

address additional provisions of these 

amendments. 

Alternatives: 

The 1986 amendments require the 

Secretary (and, by delegation, FDA) to 

establish, by regulation, requirements 

for quality factors and CGMPs, 

including quality control procedures. 

Therefore, there are no alternatives to 

rulemaking. 

Anticipated Cost and Benefits: 

FDA estimates that the costs from the 

final rule to producers of infant formula 

would include first year and recurring 

costs (e.g., administrative costs, 

implementation of quality controls, 

records, audit plans and assurances of 

quality factors in new infant formulas). 

FDA anticipates that the primary 

benefits would be a reduced risk of 

illness due to Cronobacter sakazakii 

and Salmonella spp in infant formula. 

Additional benefits stem from the 

quality factors requirements that would 

assure the healthy growth of infants 

consuming infant formula. Monetized 

estimates of costs and benefits for this 

final rule are not available at this time. 

The analysis for the proposed rule 

estimated costs of less than $1 million 

per year. FDA was not able to quantify 

benefits in the analysis for the 

proposed rule. 

Risks: 

Special controls for infant formula 

manufacturing are especially important 

because infant formula, particularly 

powdered infant formula, is an ideal 

medium for bacterial growth and 

because infants are at high risk of 

foodborne illness because of their 

immature immune systems. In addition, 

quality factors are of critical need to 

assure that the infant formula supports 

healthy growth in the first months of 

life when infant formula may be an 

infant’s sole source of nutrition. The 

provisions of this rule will address 

weaknesses in production that may 

allow contamination of infant formula, 

including, contamination with C. 

sakazakii and Salmonella spp which 

can lead to serious illness with 

devastating sequelae and/or death. The 

provisions would also assure that new 

infant formulas support healthy growth 

in infants. 

Timetable: 

Action Date FR Cite 

NPRM 07/09/96 61 FR 36154 

NPRM Comment 

Period End 

12/06/96 

NPRM Comment 

Period Reopened 

04/28/03 68 FR 22341 

NPRM Comment 

Period Extended 

06/27/03 68 FR 38247 

NPRM Comment 

Period End 

08/26/03 

NPRM Comment 

Period Reopened 

08/01/06 71 FR 43392 

NPRM Comment 

Period End 

09/15/06 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Benson Silverman 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Food Safety and Applied 

Nutrition (HFS–850) 

5100 Paint Branch Parkway 

College Park, MD 20740 

Phone: 301 436–1459 

Email: benson.silverman@fda.hhs.gov 

Related RIN: Split from 0910–AA04 

RIN: 0910–AF27 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79529 

HHS—FDA 

51. MEDICAL DEVICE REPORTING; 

ELECTRONIC SUBMISSION 

REQUIREMENTS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

21 USC 321, 331, 351, 352, 360c, 360e, 

360i to 360j, 371, 374, 381, 393; 42 

USC 264, 271 

CFR Citation: 

21 CFR 803 

Legal Deadline: 

None 

Abstract: 

The Food and Drug Administration 

(FDA) is amending its postmarket 

medical device reporting (MDR) 

regulations to require that 

manufacturers, importers, and user 

facilities submit mandatory reports of 

medical device adverse events to the 

Agency in an electronic format that 

FDA can process, review, and archive. 

FDA is taking this action to improve 

the Agency’s systems for collecting and 

analyzing postmarketing safety reports. 

The proposed change would help the 

Agency to more quickly review safety 

reports and identify emerging public 

health issues. 

Statement of Need: 

The final rule would require user 

facilities and medical device 

manufacturers and importers to submit 

medical device adverse event reports in 

electronic format instead of using a 

paper form. FDA is taking this action 

to improve its adverse event reporting 

program by enabling it to more quickly 

receive and process these reports. 

Summary of Legal Basis: 

The Agency has legal authority under 

section 519 of the Federal Food, Drug, 

and Cosmetic Act to require adverse 

event reports. The final rule would 

require manufacturers, importers, and 

user facilities to change their 

procedures to send reports of medical 

device adverse events to FDA in 

electronic format instead of using a 

hard copy form. 

Alternatives: 

There are two alternatives. The first 

alternative is to allow the voluntary 

submission of electronic MDRs. If a 

substantial number of reporters fail to 

voluntarily submit electronic MDRs, 

FDA will not obtain the benefits of 

standardized formats and quicker 

access to medical device adverse event 

data. The second alternative is to allow 

small entities more time to comply. 

Because so many device companies are 

small entities, this would significantly 

postpone the benefits of the rule. 

Anticipated Cost and Benefits: 

The principal benefit would be to 

public health because the increased 

speed in the processing and analysis 

of 173,000 medical device reports 

currently submitted annually on paper. 

In addition, requiring electronic 

submission would reduce FDA annual 

operating costs by $1.9 million and 

generate industry savings of about $9.8 

million. 

The total one-time cost for modifying 

SOPs and establishing electronic 

submission capabilities is estimated to 

range from $81.4 million to $101.0 

million. Annually recurring costs 

totaled $8.8 million and included 

maintenance of electronic submission 

capabilities, including renewing the 

electronic certificate, and for some 

firms, the incremental cost to maintain 

high-speed Internet access. 

Risks: 

None 

Timetable: 

Action Date FR Cite 

NPRM 08/21/09 74 FR 42310 

NPRM Comment 

Period End 

11/19/09 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Nancy Pirt 

Regulatory Counsel 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Devices and Radiological 

Health 

WO 66 Room 4438 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

Phone: 301 796–6248 

Fax: 301 847–8145 

Email: nancy.pirt@fda.hhs.gov 

RIN: 0910–AF86 

HHS—FDA 

52. ELECTRONIC REGISTRATION AND 

LISTING FOR DEVICES 

Priority: 

Other Significant 

Legal Authority: 

PL 110–85; PL 107–188, sec 321; PL 

107–250, sec 207; 21 USC 360(a) 

through 360(j); 21 USC 360(p) 

CFR Citation: 

21 CFR 807 

Legal Deadline: 

None 

Abstract: 

This rule will convert registration and 

listing to a paperless process. However, 

for those companies that do not have 

access to the Web, FDA will offer an 

avenue by which they can register, list, 

and update information with a paper 

submission. The rule also will amend 

part 807 to reflect the timeframes for 

device establishment registration and 

listing established by sections 222 and 

223 of Food and Drug Administration 

Amendment Act (FDAAA) and to 

reflect the requirement in section 510(i) 

of the Act, as amended by section 321 

of the Public Health Security and 

Bioterrorism Preparedness and 

Response Act (BT Act), that foreign 

establishments provide FDA with 

additional pieces of information as part 

of their registration. 

Statement of Need: 

FDA is amending the medical device 

establishment registration and listing 

requirements under 21 CFR part 807 to 

reflect the electronic submission 

requirements in section 510(p) of the 

Act, which was added by section 207 

of MDUFMA and later amended by 

section 224 of FDAAA. FDA also is 

amending 21 CFR part 807 to reflect 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79530 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

the requirements in section 321 of the 

BT Act for foreign establishments to 

furnish additional information as part 

of their registration. This rule will 

improve FDA’s device establishment 

registration and listing system and 

utilize the latest technology in the 

collection of this information. 

Summary of Legal Basis: 

The statutory basis for our authority 

includes sections 510(a) through (j), 

510(p), 701, 801, and 903 of the Act. 

Alternatives: 

The alternatives to this rulemaking 

include not updating the registration 

and listing regulations. Because of the 

new FDAAA statutory requirements 

and the advances in data collection and 

transmission technology, FDA believes 

this rulemaking is the preferable 

alternative. 

Anticipated Cost and Benefits: 

The Agency believes that there may be 

some one-time costs associated with the 

rulemaking, which involve resource 

costs of familiarizing users with the 

electronic system. Recurring costs 

related to submission of the 

information by domestic firms would 

probably remain the same or decrease 

because a paper submission and 

postage is not required. There might be 

some increase in the financial burden 

on foreign firms since they will have 

to supply additional registration 

information as required by section 321 

of the BT Act. 

Risks: 

None 

Timetable: 

Action Date FR Cite 

NPRM 03/26/10 75 FR 14510 

NPRM Comment 

Period End 

06/24/10 

Final Rule 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Nancy Pirt 

Regulatory Counsel 

Department of Health and Human 

Services 

Food and Drug Administration 

Center for Devices and Radiological 

Health 

WO 66 Room 4438 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

Phone: 301 796–6248 

Fax: 301 847–8145 

Email: nancy.pirt@fda.hhs.gov 

RIN: 0910–AF88 

HHS—Centers for Medicare & 

Medicaid Services (CMS) 

PROPOSED RULE STAGE 

53. ∑ REQUIREMENTS FOR 

LONG–TERM CARE FACILITIES: 

NOTIFICATION OF FACILITY 

CLOSURE (CMS–3230–IFC) 

Priority: 

Other Significant 

Legal Authority: 

PL 111–148, sec 6113 

CFR Citation: 

42 CFR 483; 42 CFR 488; 42 CFR 489 

Legal Deadline: 

Final, Statutory, March 23, 2011. 

Abstract: 

This rule would ensure that, in the case 

of a facility closure, any individual 

who is the administrator of the facility 

provides written notification of closure 

and the plan for the relocation of 

residents at least 60 days prior to the 

impending closure, or if the facility’s 

participation in Medicare or Medicaid 

is terminated, not later than the date 

the HHS Secretary determines 

appropriate. 

Statement of Need: 

Section 6113 of the Affordable Care Act 

of 2010 (ACA) amends the Act by 

setting forth certain requirements for 

LTC facility closures to ensure that, 

among other things, in the case of a 

facility closure, any individual who is 

the administrator of the facility 

provides written notification of the 

closure and a plan for the relocation 

of residents at least 60 days prior to 

the impending closure or, if the 

Secretary terminates the facility’s 

participation in Medicare or Medicaid, 

not later than the date the Secretary 

determines appropriate. 

Summary of Legal Basis: 

Sections 1819(b)(1)(A) of the Social 

Security Act (the Act) for NFs and 1919 

(b)(1)(A) for SNFs state that a skilled 

nursing facility must care for its 

residents in such a manner and in such 

an environment as will promote 

maintenance or enhancement of the 

quality of life of each resident. Sections 

1819(c)(2)(A) and 1919 (c)(2)(A) of the 

Act state that, in general, with certain 

specified exceptions, a nursing facility 

must permit each resident to remain in 

the facility and must not transfer or 

discharge the resident from the facility. 

Section 6113 of ACA amends section 

1128I of the Act by setting forth certain 

requirements for LTC facility closures. 

Alternatives: 

None. This implements a statutory 

requirement. 

Anticipated Cost and Benefits: 

The costs associated with the 

implementation of this rule are related 

to the efforts made by each facility to 

develop a plan for closure. The benefits 

would include the protection of 

residents’ health and safety and a 

smooth transition for residents who 

need to be relocated, as well as their 

family members and facility staff. 

Risks: 

LTC facility closures have implications 

related to access, the quality of care, 

availability of services, and the overall 

health of residents. Without an 

organized process for facilities to follow 

in the event of a nursing home closure, 

there is a risk to the health and safety 

of residents. 

Timetable: 

Action Date FR Cite 

NPRM 02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79531 

Agency Contact: 

Patricia Brooks 

Health Insurance Specialist 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Office of Clinical Standards and Quality 

Mailstop S3–02–01 

7500 Security Boulevard 

Baltimore, MD 21244 

Phone: 410 786–4561 

Email: patricia.brooks@cms.hhs.gov 

RIN: 0938–AQ09 

HHS—CMS 

54. ∑ MEDICARE SHARED SAVINGS 

PROGRAM: ACCOUNTABLE CARE 

ORGANIZATIONS (CMS–1345–P) 

Priority: 

Other Significant 

Legal Authority: 

PL 111–148, sec 3022 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

Final, Statutory, January 1, 2012. 

Abstract: 

This rule would propose a shared 

savings program for provider groups to 

establish Accountable Care 

Organizations, agree to meet quality 

measures, and share in savings 

generated for Medicare by meeting 

certain benchmarks. Consistent with 

section 3022 of the Affordable Care Act 

of 2010, the shared savings program 

must be established by January 1, 2012. 

Statement of Need: 

This rule would propose a shared 

savings program for provider groups to 

establish Accountable Care 

Organizations (ACOs), agree to meet 

quality measures, and share in savings 

generated for Medicare by meeting 

certain cost and quality benchmarks 

beginning January 1, 2012. This rule is 

aimed at improving quality and 

Medicare expenditures for Medicare 

beneficiaries and the Medicare 

program. 

Summary of Legal Basis: 

Section 3022 of the Affordable Care Act 

of 2010 requires the Secretary to 

establish a shared savings program by 

January 1, 2012. 

Alternatives: 

None. This is a statutory requirement. 

Anticipated Cost and Benefits: 

Medicare expenditures will be adjusted 

beginning January 1, 2012. 

Risks: 

If this regulation is not published, the 

shared savings program will not be 

established by January 1, 2012, as 

required by ACA, thereby violating the 

statute. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

None 

Agency Contact: 

Terri Postma 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Mail Stop C5–01–14 

7500 Seurity Boulevard 

Baltimore, MD 21244 

Phone: 410 786–4169 

Email: terri.postma@cms.hhs.gov 

RIN: 0938–AQ22 

HHS—CMS 

55. ∑ PROPOSED CHANGES TO THE 

HOSPITAL INPATIENT PROSPECTIVE 

PAYMENT SYSTEMS FOR ACUTE 

CARE HOSPITALS AND FY 2012 

RATES AND TO THE LONG–TERM 

CARE HOSPITAL PPS AND RY 2012 

RATES (CMS–1518–P) 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

sec 1886(d) of the Social Security Act 

CFR Citation: 

42 CFR 412 

Legal Deadline: 

NPRM, Statutory, April 1, 2011. 

Final, Statutory, August 1, 2011. 

Abstract: 

This annual major proposed rule would 

revise the Medicare hospital inpatient 

and long-term care prospective 

payment systems (IPPS) for operating 

and capital-related costs. This proposed 

rule would implement changes arising 

from our continuing experience with 

these systems. 

Statement of Need: 

CMS annually revises 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. In 

addition, we describe the proposed 

changes to the amounts and factors 

used to determine the rates for 

Medicare hospital inpatient services for 

operating costs and capital-related 

costs. Also, CMS annually updates the 

payment rates for the Medicare 

prospective payment system (PPS) for 

inpatient hospital services provided by 

long-term care hospitals (LTCHs). The 

proposed rule solicits comments on the 

proposed IPPS and LTCH payment 

rates and new policies. CMS will issue 

a final rule containing the payment 

rates for the FY 2012 IPPS and LTCHs 

at least 60 days before October 1, 2011. 

Summary of Legal Basis: 

The Social Security Act (the Act) sets 

forth a system of payment for the 

operating costs of acute care hospital 

inpatient stays under Medicare Part A 

(Hospital Insurance) based on 

prospectively set rates. The Act 

requires the Secretary to pay for the 

capital-related costs of hospital 

inpatient and Long-Term Care stays 

under a PPS. Under these PPSs, 

Medicare payment for hospital 

inpatient and Long-Term Care operating 

and capital-related costs is made at 

predetermined, specific rates for each 

hospital discharge. These changes 

would be applicable to services 

furnished on or after October 1, 2011. 

Alternatives: 

None. This implements a statutory 

requirement. 

Anticipated Cost and Benefits: 

Total expenditures will be adjusted for 

FY 2012. 

Risks: 

If this regulation is not published 

timely, inpatient hospital and LTCH 

services will not be paid appropriately 

beginning October 1, 2011. 

Timetable: 

Action Date FR Cite 

NPRM 04/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 


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Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Tiffany Swygert 

Health Insurance Specialist, Division of 

Acute Care, Hospital and Ambulatory 

Policy Group 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Mailstop C4–25–11 

7500 Security Boulevard 

Baltimore, MD 21244 

Phone: 410 786–4642 

Email: tiffany.swygert@cms.hhs.gov 

RIN: 0938–AQ24 

HHS—CMS 

56. ∑ REVISIONS TO PAYMENT 

POLICIES UNDER THE PHYSICIAN 

FEE SCHEDULE AND PART B FOR CY 

2012 (CMS–1524–P) 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

Social security Act, sec 1102; Social 

Security Act, sec 1871 

CFR Citation: 

42 CFR 405; 42 CFR 410 to 411; 42 

CFR 413 to 414; 42 CFR 426 

Legal Deadline: 

Final, Statutory, November 1, 2011. 

The statute requires that the final rule 

be issued by November. 

Abstract: 

This proposed rule would revise 

payment polices under the physician 

fee schedule, as well as other policy 

changes to payment under Part B. 

These changes would be applicable to 

services furnished on or after January 

1, annually. 

Statement of Need: 

The statute requires that we establish 

each year, by regulation, payment 

amounts for all physicians’ services 

furnished in all fee schedule areas. This 

major proposed rule would make 

changes affecting Medicare Part B 

payment to physicians and other Part 

B suppliers. 

The final rule has a statutory 

publication date of November 1, 2011, 

and an implementation date of January 

1, 2012. 

Summary of Legal Basis: 

Section 1848 of the Social Security Act 

(the Act) establishes the payment for 

physician services provided under 

Medicare. Section 1848 of the Act 

imposes a deadline of no later than 

November 1 for publication of the final 

physician fee schedule rule. 

Alternatives: 

None. This implements a statutory 

requirement. 

Anticipated Cost and Benefits: 

Total expenditures will be adjusted for 

CY 2012. 

Risks: 

If this regulation is not published 

timely, physician services will not be 

paid appropriately. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Carol Bazell 

Director, Division of Practitioner Services 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Mail Stop C4–03–06 

7500 Security Boulevard 

Baltimore, MD 21244 

Phone: 410 786–6960 

Email: carol.bazell@cms.hhs gov 

RIN: 0938–AQ25 

HHS—CMS 

57. ∑ CHANGES TO THE HOSPITAL 

OUTPATIENT PROSPECTIVE 

PAYMENT SYSTEM AND 

AMBULATORY SURGICAL CENTER 

PAYMENT SYSTEM FOR CY 2012 

(CMS–1525–P) 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

sec 1833 of the Social Security Act 

CFR Citation: 

42 CFR 410; 42 CFR 416 ; 42 CFR 419 

Legal Deadline: 

Final, Statutory, November 1, 2011. 

Abstract: 

This proposed rule would revise the 

Medicare hospital outpatient 

prospective payment system to 

implement applicable statutory 

requirements and changes arising from 

our continuing experience with this 

system. The proposed rule also 

describes changes to the amounts and 

factors used to determine payment rates 

for services. In addition, the rule 

proposes changes to the Ambulatory 

Surgical Center Payment System list of 

services and rates. 

Statement of Need: 

Medicare pays over 4,000 hospitals for 

outpatient department services under 

the hospital outpatient prospective 

payment system (OPPS). The OPPS is 

based on groups of clinically similar 

services called ambulatory payment 

classification groups (APCs). CMS 

annually revises the APC payment 

amounts based on the most recent 

claims data, proposes new payment 

policies, and updates the payments for 

inflation using the hospital operating 

market basket. The proposed rule 

solicits comments on the proposed 

OPPS payment rates and new policies. 

Medicare pays roughly 5,000 

Ambulatory Surgical Centers (ASCs) 

under the ASC payment system. CMS 

annually revises the payment under the 

ASC payment system, proposes new 

policies, and updates payments for 

inflation using the Consumer Price 

Index for All Urban Consumers (CPIU). CMS will issue a final rule 

containing the payment rates for the 

2012 OPPS and ASC payment system 

at least 60 days before January 1, 2012. 

Summary of Legal Basis: 

Section 1833 of the Social Security Act 

establishes Medicare payment for 

hospital outpatient services and ASC 

services. The final rule revises the 

Medicare hospital OPPS and ASC 

payment system to implement 

applicable statutory requirements. In 

addition, the proposed and final rules 

describe changes to the outpatient APC 

system, relative payment weights, 

outlier adjustments, and other amounts 

and factors used to determine the 

payment rates for Medicare hospital 

outpatient services paid under the 


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prospective payment system as well as 

changes to the rates and services paid 

under the ASC payment system. These 

changes would be applicable to services 

furnished on or after January 1, 2012. 

Alternatives: 

None. This is a statutory requirement. 

Anticipated Cost and Benefits: 

Total expenditures will be adjusted for 

CY 2012. 

Risks: 

If this regulation is not published 

timely, outpatient hospital and ASC 

services will not be paid appropriately 

beginning January 1, 2012. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Federal 

Federalism: 

Undetermined 

Agency Contact: 

Alberta Dwivedi 

Health Insurance Specialist 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

Mailstop C5–01–26 

7500 Security Boulevard 

Baltimore, MD 21244 

Phone: 410 786–0763 

Email: alberta.dwivedi@cms.hhs.gov 

RIN: 0938–AQ26 

HHS—CMS 

FINAL RULE STAGE 

58. ∑ CIVIL MONEY PENALTIES FOR 

NURSING HOMES (CMS–2435–F) 

Priority: 

Other Significant 

Legal Authority: 

42 USC 1302 and 1395 (hh) 

CFR Citation: 

42 CFR 488 

Legal Deadline: 

Final, Statutory, March 23, 2011, 1 year 

after enactment of PPACA. 

Abstract: 

This rule revises and expands current 

Medicare and Medicaid regulations 

regarding the imposition of civil money 

penalties by CMS when nursing homes 

are not in compliance with Federal 

participation requirements. 

Statement of Need: 

The intent of this final rule is to 

improve the efficiency and 

effectiveness of the nursing home 

enforcement process, particularly as it 

relates to civil money penalties 

imposed by CMS. The new provisions 

will reduce the delay between the 

identification of problems with 

noncompliance and the effect of certain 

penalties that are intended to motivate 

a nursing home to maintain continuous 

compliance with basic expectations 

regarding the provision of quality care. 

The new provisions also eliminate a 

facility’s ability to significantly defer 

the direct financial effect of an 

applicable civil monetary penalty until 

after an often long litigation process. 

Specifically, this rule would allow for 

civil money penalty reductions when 

facilities self-report and promptly 

correct their noncompliance; offer, in 

cases where civil money penalties are 

imposed, an independent informal 

dispute resolution process where 

interests of both facilities and residents 

are represented and balanced; provide 

for the establishment of an escrow 

account where civil money penalties 

may be placed until any applicable 

administrative appeal processes have 

been completed; and improve the 

extent to which civil money penalties 

collected from Medicare facilities can 

benefit nursing home residents. 

Through the proposed revisions, we 

intend to directly promote and improve 

the health, safety, and overall wellbeing of residents. 

Summary of Legal Basis: 

Section 6111 of the Affordable Care Act 

of 2010 amended the Act to incorporate 

specific provisions pertaining to the 

imposition and collection of civil 

money penalties when facilities do not 

meet Medicare and Medicaid 

participation requirements. 

Alternatives: 

None. This rule implements a statutory 

requirement. The proposed rule was 

published on July 12, 2010. 

Alternatives proposed by commenters 

will be considered in the preparation 

of the final rule. 

Anticipated Cost and Benefits: 

The regulatory impact statement 

provides that these regulatory proposals 

would have no consequential effect on 

State, local, or tribal governments or on 

the private sector. The anticipated 

benefits of this regulation include 

stronger protections for nursing home 

residents, improved due process for 

nursing homes, incentives for prompt 

self-correction of deficiencies, and 

increased quality improvement. 

Risks: 

CMS does not expect any additional 

risks to providers and/or States as a 

result of the implementation of this 

rule. 

Timetable: 

Action Date FR Cite 

NPRM 07/12/10 75 FR 39641 

NPRM Comment 

Period End 

08/11/10 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

State 

Agency Contact: 

Dr. Lori Chapman 

Acting Director, Division of State 

Demonstrations and Waivers 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid Services 

7500 Security Boulevard 

Baltimore, MD 21220 

Phone: 410 786–9254 

Email: lori.chapman@cms.hhs.gov 

RIN: 0938–AQ02 

HHS—Administration for Children and 

Families (ACF) 

PROPOSED RULE STAGE 

59. DESIGNATION RENEWAL OF 

HEAD START GRANTEES 

Priority: 

Other Significant 

Legal Authority: 

Improving Head Start for School 

Readiness Act of 2007, PL 110–134 

CFR Citation: 

Not Yet Determined 


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Legal Deadline: 

None 

Abstract: 

This rule would implement provisions 

of the Improving Head Start for School 

Readiness Act of 2007 (Pub. L. 110- 

134), requiring the Secretary to develop 

a system that will evaluate each 

grantee’s performance every 5 years to 

determine which grantees are providing 

services of such high quality that they 

should be given another 5-year grant 

without needing to recompete for the 

grant. 

Statement of Need: 

The Administration for Children and 

Families will issue rules to amend 45 

CFR chapter XIII by adding a new part 

1307, Policies and Procedures for 

Designation Renewal of Head Start and 

Early Head Start Grantees, in order to 

respond to the statutory requirements 

of The Improving Head Start for School 

Readiness Act of 2007, which 

establishes that Head Start grantees will 

be awarded grants for a 5-year period 

and only grantees delivering high 

quality services will be given another 

5-year grant non-competitively. These 

regulations will describe the proposed 

system for designation renewal, 

including a proposal to transition all 

current continuous grants into 5-year 

grants over a 3-year period. These 

regulations will encourage excellence, 

establish accountability for poor 

performance, and open up Head Start 

to new energetic organizations that may 

have great capacity to run high quality 

programs. 

Summary of Legal Basis: 

Section 641 of the Head Start Act 

requires the Secretary of HHS to 

develop and implement a system for 

designation renewal (e.g., Designation 

Renewal System (DRS)) to determine if 

a Head Start agency is delivering a 

high-quality and comprehensive Head 

Start program that meets the 

educational, health, nutritional, and 

social needs of the children and 

families it serves and publish a notice 

in the Federal Register describing a 

proposed system for designation 

renewal, including a proposal for the 

transition to such system. 

Alternatives: 

The Administration for Children and 

Families is statutorily mandated to 

develop and implement a system for 

designation renewal. As a precursor to 

developing the system, the Head Start 

Act required the Secretary to establish 

an Advisory Committee to inform the 

development of a DRS and make 

recommendations to the Secretary. We 

are proposing to adopt the majority of 

the Advisory Committee’s 

recommendations in whole or with 

minor modifications. In addition, we 

are considering additional and 

alternative criteria to be incorporated 

into the system for designation renewal, 

and ask for public comments regarding 

numerous provisions of the rule, as 

described in the preamble. 

Anticipated Cost and Benefits: 

The Agency estimates the costs of 

implementing the new reporting 

requirements described in the rule will 

be approximately $20,000 annually. In 

addition, at least 25 percent of grantees 

reviewed in a year will be required to 

submit a competitive application for a 

new 5-year grant, at an estimated cost 

of less than $1,500 for each grantee. 

In terms of benefits, the proposed 

system will fund only high-performing 

grantees in order to ensure the best 

services for Head Start children are 

provided and child outcomes are 

improved. 

Timetable: 

Action Date FR Cite 

NPRM 09/22/10 75 FR 57704 

NPRM Comment 

Period End 

12/21/10 

Final Action 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Agency Contact: 

Collen Rathgeb 

Department of Health and Human 

Services 

Administration for Children and Families 

1250 Maryland Avenue SW. 

Washington, DC 20447 

Phone: 202 205–7378 

Email: crathgeb@acf.hhs.gov 

RIN: 0970–AC44 

HHS—Administration on Aging (AOA) 

PROPOSED RULE STAGE 

60. ∑ COMMUNITY LIVING 

ASSISTANCE SERVICES AND 

SUPPORTS ENROLLMENT AND 

ELIGIBILITY RULES UNDER THE 

AFFORDABLE CARE ACT 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

PL 111–148, sec 8002 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

The Department of Health and Human 

Services will issue rules to implement 

the Community Living Assistance 

Services and Supports (CLASS) 

program included in the Affordable 

Care Act. Specifically, the rules will 

define the enrollment and eligibility 

criteria for the program. Participation 

in the program is voluntary. 

Statement of Need: 

About 14 million people spend more 

than $230 billion a year on long-term 

services and supports to assist them 

with daily living. Four times that many 

rely solely on unpaid care provided by 

family and friends. Medicare does not 

pay for long-term care, and while 

Medicaid is the largest public payer of 

these services, it is only available for 

people with few other resources. The 

CLASS program represents a significant 

new opportunity for all Americans to 

prepare themselves financially to 

remain as independent as possible 

under a variety of future health 

circumstances. 

Summary of Legal Basis: 

Section 8002 of Public Law 111-148 

(Affordable Care Act) requires the 

promulgation of regulations to 

implement the CLASS program. 

Specifically, the law states, ‘‘[t]he 

Secretary shall promulgate such 

regulations as are necessary to carry out 

the CLASS program in accordance with 

this title. Such regulations shall include 

provisions to prevent fraud and abuse 

under the program.’’ 


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Alternatives: 

Under the law, the Secretary, in 

consultation with appropriate actuaries 

and other experts, will develop at least 

three actuarially sound benefit plans as 

alternatives for consideration for 

designation by the Secretary as the 

CLASS Independence Benefit Plan. 

Under the law, the Secretary will 

designate the final benefit plan by 

October 1, 2012. 

Anticipated Cost and Benefits: 

The program will help Americans 

prepare themselves financially to 

remain as independent as possible 

under a variety of future health 

circumstances and their financial 

independence may help reduce 

spending down to Medicaid. Costs to 

implement the proposed regulation 

have not yet been estimated. 

Timetable: 

Action Date FR Cite 

NPRM 09/00/11 

Final Action 10/00/12 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Agency Contact: 

Laura Lawrence 

Department of Health and Human 

Services 

Administration on Aging 

Phone: 202 357–3469 

RIN: 0985–AA07 

BILLING CODE 4150–24–S 


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DEPARTMENT OF HOMELAND 

SECURITY (DHS) 

Statement of Regulatory Priorities 

The Department of Homeland 

Security (DHS) was created in 2003 

pursuant to the Homeland Security Act 

of 2002, Public Law 107-296. DHS has 

a vital mission: To secure the nation 

from the many threats we face. This 

requires the dedication of more than 

225,000 employees in jobs that range 

from aviation and border security to 

emergency response, from cybersecurity 

analyst to chemical facility inspector. 

Our duties are wide-ranging, but our 

goal is clear—keeping America safe. 

Our mission gives us five main areas 

of responsibility: 

1. Guarding against Terrorism; 

2. Securing our Borders; 

3. Enforcing our Immigration Laws; 

4. Improving our Readiness for, 

Response to, and Recovery from 

Disasters; and 

5. Maturing and Unifying the 

Department. 

In achieving these goals, we are 

continually strengthening our 

partnerships with communities, first 

responders, law enforcement, and 

government agencies—at the State, 

local, tribal, Federal, and international 

levels. We are accelerating the 

deployment of science, technology, and 

innovation in order to make America 

more secure, and we are becoming 

leaner, smarter, and more efficient, 

ensuring that every security resource is 

used as effectively as possible. For a 

further discussion of our five main areas 

of responsibility, see the DHS website at 

http://www.dhs.gov/xabout/ 

responsibilities.shtm. 

The regulations we have summarized 

below in the Department’s fall 2010 

regulatory plan and in the Unified 

Agenda support the Department’s five 

responsibility areas listed above. These 

regulations will improve the 

Department’s ability to accomplish its 

mission. 

The regulations we have identified in 

this year’s fall regulatory plan continue 

to address legislative initiatives 

including, but not limited to, the 

following acts: The Implementing 

Recommendations of the 9/11 

Commission Act of 2008 (9/11 Act), 

Public Law 110-53 (Aug. 3, 2007); the 

Post-Katrina Emergency Management 

Reform Act of 2006 (PKEMRA), Public 

Law 109-295 (Oct. 4, 2006); the 

Consolidated Natural Resources Act of 

2008 (CNRA), Public Law No. 110-220 

(May 7, 2008); the Security and 

Accountability for Every Port Act of 

2006 (SAFE Port Act), Public Law 109- 

347 (Oct. 13, 2006); and the 

Consolidated Security, Disaster 

Assistance, and Continuing 

Appropriations Act, 2009, Public Law 

110-329 (Sep. 30, 2008). 

DHS strives for organizational 

excellence and uses a centralized and 

unified approach in managing its 

regulatory resources. The Office of the 

General Counsel manages the 

Department’s regulatory program, 

including the Unified Agenda and The 

Regulatory Plan. In addition, DHS 

senior leadership reviews each 

significant regulatory project to ensure 

that the project fosters and supports the 

Department’s mission. 

DHS 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. DHS is also 

committed to the principles described 

in Executive Order 12866, as amended, 

such as promulgating regulations that 

are cost-effective and maximizing the 

net benefits of regulations. The 

Department values public involvement 

in the development of its regulatory 

plan, agenda, and regulations, and takes 

particular concern with the impact its 

rules have on small businesses. DHS 

and each of its components continue to 

emphasize the use of plain language in 

our notices and rulemaking documents 

to promote a better understanding of 

regulations and increased public 

participation in the Department’s 

rulemakings. 

The fall 2010 Regulatory Plan for DHS 

includes regulations from DHS 

components—including U.S. 

Citizenship and Immigration Services 

(USCIS), the U.S. Coast Guard (Coast 

Guard), U.S. Customs and Border 

Protection (CBP), the Federal Emergency 

Management Agency (FEMA), the U.S. 

Immigration and Customs Enforcement 

(ICE), and the Transportation Security 

Administration (TSA), which have 

active regulatory programs. In addition, 

it includes regulations from the 

Department’s major offices and 

directorates such as the National 

Protection and Programs Directorate 

(NPPD). Below is a discussion of the fall 

2010 regulatory plan for DHS regulatory 

components, as well as for DHS offices 

and directorates. 

United States Citizenship and 

Immigration Services 

U.S. Citizenship and Immigration 

Services (USCIS) administer 

immigration benefits and services while 

protecting homeland security. USCIS 

has a strong commitment to welcoming 

individuals who seek entry through the 

U.S. immigration system, providing 

clear and useful information regarding 

the immigration process, promoting the 

values of citizenship, and assisting 

those in need of humanitarian 

protection. Based on a comprehensive 

review of the planned USCIS regulatory 

agenda, USCIS will promulgate several 

rulemakings to directly support these 

commitments and goals. 

Regulations Related to the 

Commonwealth of Northern Mariana 

Islands 

During 2009, USCIS issued a series of 

regulations to implement the extension 

of U.S. immigration law to the 

Commonwealth of Northern Mariana 

Islands (CNMI), as required under title 

VII of the Consolidated Natural 

Resources Act of 2008. USCIS will issue 

the following CNMI final rules during 

fiscal year 2011: ‘‘CNMI Transitional 

Worker Classification,’’ ‘‘E-2 

Nonimmigrant Status for Aliens of the 

CNMI with Long-Term Investor Status,’’ 

and the joint USCIS/Department of 

Justice (DOJ) regulation ‘‘Application of 

Immigration Regulations to the CNMI.’’ 

Improvements to the Immigration 

System 

USCIS is currently engaged in a multiyear transformation effort to create a 

more efficient, effective, and customerfocused organization by improving our 

business processes and technology. In 

the coming years, USCIS will publish 

several rules to facilitate that effort. To 

improve customer service specifically, 

USCIS is pursuing a regulatory initiative 

that will provide for selection of visa 

numbers by lottery for H-1B petitions 

based on electronic registration. 

Registration Requirements for 

Employment-Based Categories Subject 

to Numerical Limitations 

USCIS will propose a revised 

registration process for H-1B petitioners 

who are subject to a numerical limit or 

‘‘cap.’’ The rule would propose to create 

a process by which USCIS would 

randomly select a sufficient number of 

timely filed registrations to meet the 

applicable cap. Only petitioners whose 

registrations are randomly selected 

would be eligible to file an H-1B 

petition for a cap-subject prospective 

worker. Enhancing customer service, the 


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rule would eliminate the need for 

petitioning employers to prepare and 

file complete H-1B petitions before 

knowing whether a prospective worker 

has ‘‘won’’ the H-1B lottery. The rule 

would also reduce the costs incurred by 

USCIS in entering data and 

subsequently returning non-selected 

petitions to employers once the cap is 

reached. 

Regulatory Changes Involving 

Humanitarian Benefits 

USCIS offers protection to individuals 

who face persecution by adjudicating 

applications for refugees and asylees. 

Other humanitarian benefits are 

available to individuals who have been 

victims of severe forms of trafficking or 

criminal activity. 

Asylum and Withholding Definitions 

USCIS plans a regulatory proposal to 

amend the regulations that govern 

asylum eligibility. The amendments are 

expected to focus on portions of the 

regulations that deal with 

determinations of whether persecution 

is inflicted on account of a protected 

ground, the requirements for 

establishing the failure of State 

protection, and the definition of 

membership in a particular social group. 

This effort should provide greater 

stability and clarity in this important 

area of the law. 

Exception to the Persecution Bar for 

Asylum, Refugee, or Temporary 

Protected Status, and Withholding of 

Removal 

DHS, in a joint rulemaking with DOJ, 

will propose amendments to existing 

DHS and DOJ regulations to resolve 

ambiguity in the statutory language 

precluding eligibility for asylum, 

refugee resettlement, temporary 

protected status, and withholding of 

removal of an applicant who ordered, 

incited, assisted, or otherwise 

participated in the persecution of 

others. The proposed rule would 

provide a limited exception for 

persecutory actions taken by the 

applicant under duress and clarify the 

required levels of the applicant’s 

knowledge of the persecution. 

‘‘T’’ and ‘‘U’’ Nonimmigrants 

USCIS plans additional regulatory 

initiatives related to T nonimmigrants 

(victims of trafficking), U 

nonimmigrants (victims of criminal 

activity), and Adjustment of Status for T 

and U status holders. By promulgating 

additional regulations related to these 

victims of specified crimes or severe 

forms of human trafficking, USCIS 

hopes to provide greater stability for 

these vulnerable groups, their 

advocates, and the community. These 

rulemakings will contain provisions that 

seek to ease documentary requirements 

for this vulnerable population and 

provisions that provide greater clarity to 

the law enforcement community. In 

addition, publication of these rules will 

inform the community about how their 

petitions are adjudicated. 

United States Coast Guard 

The U.S. Coast Guard (Coast Guard) is 

a military, multi-mission, maritime 

service of the United States and the only 

military organization within DHS. It is 

the principal Federal agency responsible 

for maritime safety, security, and 

stewardship and delivers daily value to 

the Nation through multi-mission 

resources, authorities, and capabilities. 

Effective governance in the maritime 

domain hinges upon an integrated 

approach to safety, security, and 

stewardship. The Coast Guard’s policies 

and capabilities are integrated and 

interdependent, delivering results 

through a network of enduring 

partnerships. The Coast Guard’s ability 

to field versatile capabilities and highlytrained personnel is one of the U.S. 

Government’s most significant and 

important strengths in the maritime 

environment. 

America is a maritime nation, and our 

security, resilience, and economic 

prosperity are intrinsically linked to the 

oceans. Safety, efficient waterways, and 

freedom of transit on the high seas are 

essential to our well-being. The Coast 

Guard is leaning forward, poised to 

meet the demands of the new 

millennium. The Coast Guard creates 

value for the public through solid 

prevention and response efforts. 

Activities involving oversight and 

regulation, enforcement, maritime 

presence, and public and private 

partnership foster increased maritime 

safety, security, and stewardship. 

The statutory responsibilities of the 

Coast Guard 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 

goals of mobilizing and organizing our 

Nation to secure the homeland from 

terrorist attacks, natural disasters, and 

other emergencies. The rulemaking 

projects identified for the Coast Guard 

in the Unified Agenda, and the rules 

appearing in the fall 2010 Regulatory 

Plan below, contribute to the fulfillment 

of those responsibilities and reflect our 

regulatory policies. The Coast Guard’s 

rulemaking projects support maritime 

safety, security, and environmental 

protection as indicated by the wide 

range of topics covered in its 

rulemaking projects in this Unified 

Agenda. 

Inspection of Towing Vessels 

In 2004, Congress amended U.S. law 

by adding towing vessels to the types of 

commercial vessels that must be 

inspected by the Coast Guard. Congress 

also provided guidance relevant to the 

use of a safety management system as 

part of the inspection regime. The intent 

of the proposed rule is to promote safer 

work practices and reduce casualties on 

towing vessels by ensuring that towing 

vessels adhere to prescribed safety 

standards and safety management 

systems. The proposed rule was 

developed in cooperation with the 

Towing Vessel Safety Advisory 

Committee (TSAC). It would establish a 

new subchapter dedicated to towing 

vessels and covering vessel equipment, 

systems, operational standards, and 

inspection requirements. To implement 

this change, the Coast Guard is 

developing regulations to prescribe 

standards, procedures, tests, and 

inspections for towing vessels. This 

rulemaking supports maritime safety 

and maritime stewardship. 

Standards for Living Organisms in 

Ships’ Ballast Water Discharged in U.S. 

Waters 

This rule would set performance 

standards for the quality of ballast water 

discharged in U.S. waters and require 

that all vessels that operate in U.S. 

waters and are bound for ports or places 

in the U.S. and are equipped with 

ballast tanks, install and operate a Coast 

Guard approved Ballast Water 

Management System (BWMS) before 

discharging ballast water into U.S. 

waters. This would include vessels 

bound for offshore ports or places. As 

the effectiveness of ballast water 

exchange varies from vessel to vessel, 

the Coast Guard believes that setting 

performance standards would be the 

most effective way for approving BWMS 

that are environmentally protective and 

scientifically sound. Ultimately, the 

approval of BWMS would require 

procedures similar to those located in 

title 46, subchapter Q, of the Code of 

Federal Regulations, to ensure that the 

BWMS works, not only in the 

laboratory, but also under shipboard 

conditions. These would include: Preapproval requirements, application 

requirements, land-based/shipboard 


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testing requirements, design and 

construction requirements, electrical 

requirements, engineering requirements, 

and piping requirements. This 

requirement is intended to meet the 

requirements of the National Invasive 

Species Act (NISA). Ballast water 

discharged from ships is a significant 

pathway for the introduction and spread 

of non-indigenous aquatic nuisance 

species. These organisms, which may be 

plants, animals, bacteria, or pathogens, 

have the potential to displace native 

species, degrade native habitats, spread 

disease, and disrupt human economic 

and social activities that depend on 

water resources. This rulemaking 

supports maritime stewardship. 

Outer Continental Shelf Activities 

The Coast Guard is revising 

regulations to address new 

developments in the offshore industry, 

to fully address existing legislation, to 

effectively implement interagency 

agreements, to respond to comments 

received from the notice of proposed 

rulemaking (Outer Continental Shelf 

Activities, 64 FR 68416 (Dec. 7, 1999), 

and to update security requirements and 

procedures. This proposed rule would 

improve the level of safety in the 

workplace and security for personnel 

and units engaged in Outer Continental 

Shelf (OCS) activities. The Coast Guard 

is the lead Federal agency for OCS 

workplace safety and health—other than 

for matters generally related to drilling 

and production that are regulated by the 

Bureau of Ocean Energy Management, 

Regulation, and Enforcement—on 

facilities and vessels engaged in the 

exploration for, or development or 

production of, minerals on the OCS. The 

last major revision of the Coast Guard’s 

OCS regulations occurred in 1982. At 

that time, the offshore industry was not 

as technologically advanced as it is 

today. Offshore activities were in 

relatively shallow water near land, 

where help was readily available during 

emergency situations. The regulations 

required only basic equipment, 

primarily for lifesaving appliances and 

hand-held portable fire extinguishers. 

Since 1982, the requirements in 33 CFR 

chapter I, subchapter N, have not kept 

pace with the changing offshore 

technology or the safety problems it 

creates as OCS activities extend to 

deeper water (10,000 feet) and move 

farther offshore (150 miles). This 

rulemaking would reassess all of the 

Coast Guard’s current OCS regulations 

in order to help make the OCS a safer 

workplace, and it supports the 

Commandant’s strategic goals of marine 

safety and environmental stewardship. 

Updates to 33 CFR Subchapter H— 

Maritime Security. 

The intent of this rulemaking is to 

strengthen security of our Nation’s 

ports, vessels, facilities, and Outer 

Continental Shelf facilities by 

incorporating clarifications realized 

since the original Maritime 

Transportation Security Act (MTSA) 

regulations of 2003, Security and 

Accountability for Every Port Act of 

2006 (SAFE Port Act) requirements, and 

the Coast Guard and Maritime 

Transportation Act of 2006.This 

proposed rule would incorporate 

feedback received from industry 

stakeholders, Coast Guard field units, 

and the public since the original MTSA 

regulations came into effect in 2003. 

The proposed rule would also 

consolidate into regulation appropriate 

actions promulgated in a series of Policy 

Advisory Council (PAC) papers, 

Navigation and Inspection Circulars 

(NVICs), and MTSA Help Desk 

responses; address screening standards 

for port facilities and vessels; establish 

security training standards that will be 

modeled after the courses developed by 

the Maritime Administration (MARAD); 

and the training standards (mandatory 

and non-mandatory) and courses 

developed by the International Maritime 

Organization (IMO). It would also 

update existing regulations regarding 

the areas of maritime security plans, 

facility and vessel security plans, and 

facility exercise requirements in the 

SAFE Port Act of 2006. This rulemaking 

supports the Commandant’s strategic 

goal of maritime security. 

Assessment Framework and 

Organizational Restatement Regarding 

Preemption for Certain Regulations 

Issued by the Coast Guard 

This rule would restate the 

preemptive effect of existing Coast 

Guard regulations and articulate the 

assessment framework for evaluating the 

preemptive effect of future regulations. 

This rule would not alter the 

preemptive effect of any regulation: It 

would merely restate the existing law. 

By clarifying the preemptive effect of 

Coast Guard regulations, the Coast 

Guard intends to increase transparency, 

encourage appropriate State regulation, 

and avoid or reduce litigation related to 

State and local attempts to regulate in 

preempted areas. In doing so, the Coast 

Guard intends to comply with the May 

2009 presidential memoranda on 

preemption, and on transparency and 

open government, and also intends to 

reinforce a uniform maritime regulatory 

regime that is predictable and useful for 

maritime interests. The Coast Guard 

expects no additional cost impacts to 

the industry from this rule, because it 

only restates and clarifies the status of 

Federal and State law as it exists. 

The following Coast Guard 

rulemakings may be of particular 

interest to small entities: 

Inspection of Towing Vessels 

Based on preliminary analysis, the 

Coast Guard determined 1,059 operators 

of 5,208 uninspected towing vessels 

would incur additional costs from this 

rulemaking and over 92 percent of these 

entities are small businesses. This 

rulemaking would require operators of 

previously uninspected towing vessels 

to incur the costs of becoming regulated 

under a new inspection regime. 

Standards for Living Organisms in 

Ships’ Ballast Water Discharged in U.S. 

Waters 

Based on preliminary analysis in the 

notice of proposed rulemaking (74 FR 

44632), the Coast Guard determined 850 

U.S. operators of 2,616 vessels would 

incur additional costs from this 

rulemaking and over 57 percent of these 

entities are small businesses. This 

rulemaking would require operators to 

purchase and install ballast water 

management systems costing between 

$258,000 and $419,000 per vessel, 

depending vessel and technology type. 

Updates to 33 CFR Subchapter H— 

Maritime Security 

Based on preliminary analysis, the 

Coast Guard determined that 55 percent 

of operators affected by this rulemaking 

are small entities. This rulemaking 

would require operators to incur 

additional costs for training and 

exercise provisions. 

United States Customs and Border 

Protection 

U.S. Customs and Border Protection 

(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 is also responsible for 

administering laws concerning the 


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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 

United States; maintaining export 

controls; and protecting U.S. 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. 

Consistent with its primary mission of 

homeland security, CBP intends to 

finalize several rules during the next 

fiscal year that are intended to improve 

security at our borders and ports of 

entry. We have highlighted some of 

these rules below. 

Electronic System for Travel 

Authorization (ESTA). 

On June 9, 2008, CBP published an 

interim final rule amending DHS 

regulations to implement the Electronic 

System for Travel Authorization (ESTA) 

for aliens who wish to enter the United 

States under the Visa Waiver Program 

(VWP) at air or sea ports of entry. This 

rule is intended to fulfill the 

requirements of section 711 of the 

Implementing Recommendations of the 

9/11 Commission Act of 2007 (9/11 

Act). The rule establishes ESTA and 

delineates the data field DHS has 

determined will be collected by the 

system. The rule requires that each alien 

traveling to the United States under the 

VWP must obtain electronic travel 

authorization via the ESTA System in 

advance of such travel. VWP travelers 

may obtain the required ESTA 

authorization by electronically 

submitting to CBP biographic and other 

information as currently required by the 

I-94W Nonimmigrant Alien 

Arrival/Departure Form (I-94W). By 

Federal Register notice dated November 

13, 2008, the Secretary of Homeland 

Security informed the public that ESTA 

would become mandatory beginning 

January 12, 2009. This means that all 

VWP travelers must either obtain travel 

authorization in advance of travel under 

ESTA or obtain a visa prior to traveling 

to the United States. 

By shifting from a paper to an 

electronic form and requiring the data in 

advance of travel, CBP will be able to 

determine before the alien departs for 

the U.S., the eligibility of nationals from 

VWP countries to travel to the United 

States and to determine whether such 

travel poses a law enforcement or 

security risk. By modernizing the VWP, 

the ESTA is intended to increase 

national security and provide for greater 

efficiencies in the screening of 

international travelers by allowing for 

vetting of subjects of potential interest 

well before boarding, thereby reducing 

traveler delays based on lengthy 

processes at ports of entry. CBP intends 

to issue a final rule during the next 

fiscal year. On August 9, 2010, CBP 

published an interim final rule 

amending the ESTA regulations to 

require ESTA applicants to pay a 

congressionally mandated fee which is 

the sum of two amounts: a $10 travel 

promotion fee for an approved ESTA 

and a $4 operational fee for the use of 

ESTA set by the Secretary of Homeland 

Security to, at a minimum, ensure the 

recovery of the full costs of providing 

and administering the ESTA. CBP is 

working to finalize the 2008 and 2010 

interim final rules during fiscal year 

2011. 

Importer Security Filing and Additional 

Carrier Requirements 

The Security and Accountability for 

Every Port Act of 2006 (SAFE Port Act) 

calls for CBP to promulgate regulations 

to require the electronic transmission of 

additional data elements for improved 

high-risk targeting. See Public Law No. 

109-347, section 203 (Oct. 13, 2006). 

This includes appropriate security 

elements of entry data for cargo destined 

for the United States by vessel prior to 

loading of such cargo on vessels at 

foreign seaports. The SAFE Port Act 

requires that the information collected 

reasonably improve CBP’s ability to 

identify high-risk shipments to prevent 

smuggling and ensure cargo safety and 

security. 

On November 25, 2008, CBP 

published an interim final rule 

‘‘Importer Security Filing and 

Additional Carrier Requirements,’’ 

amending CBP regulations to require 

carriers and importers to provide to 

CBP, via a CBP-approved electronic data 

interchange system, information 

necessary to enable CBP to identify 

high-risk shipments to prevent 

smuggling and ensure cargo safety and 

security. This rule, which became 

effective on January 26, 2009, improves 

CBP risk assessment and targeting 

capabilities, facilitates the prompt 

release of legitimate cargo following its 

arrival in the United States, and assists 

CBP in increasing the security of the 

global trading system. The comment 

period for the interim final rule 

concluded on June 1, 2009. CBP is 

analyzing comments and conducting a 

structured review of certain flexibility 

provided in the interim final rule. CBP 

intends to publish a final rule during 

fiscal year 2011. 

Implementation of the Guam-CNMI Visa 

Waiver Program 

CBP published an interim final rule in 

November 2008 amending the DHS 

regulations to replace the current Guam 

Visa Waiver Program with a new GuamCNMI Visa Waiver program. This rule 

implements portions of the 

Consolidated National Resources Act of 

2008 (CNRA), which extends the 

immigration laws of the United States to 

the Commonwealth of the Northern 

Mariana Islands (CNMI) and, among 

others things, provides for a visa waiver 

program for travel to Guam and the 

CNMI. The amended regulations set 

forth the requirements for nonimmigrant 

visitors who seek admission for 

business or pleasure and solely for entry 

into and stay on Guam or the CNMI 

without a visa. The rule also establishes 

six ports of entry in the CNMI for 

purposes of administering and enforcing 

the Guam-CNMI Visa Waiver program. 

CBP intends to issue a final rule during 

fiscal year 2011. 

Global Entry Program 

Pursuant to section 7208(k) of the 

Intelligence Reform and Terrorism 

Prevention Act of 2004, as amended, 

CBP issued a notice of proposed 

rulemaking (NPRM) in the fall of 2009, 

proposing to establish an international 

trusted traveler program called Global 

Entry. This voluntary program would 

allow CBP to expedite clearance of preapproved, low-risk air travelers into the 

United States. CBP has been operating 

the Global Entry program as a pilot at 

several airports since June 6, 2008. 

Based on the successful operation of the 

pilot, CBP proposed to establish Global 

Entry as a permanent voluntary 

regulatory program. CBP will evaluate 

the public comments received in 

response to the NPRM, in order to 

develop a final rule. CBP intends to 

issue a final rule during fiscal year 2011. 

The rules discussed above foster DHS’ 

mission. Under section 403(1) of the 

Homeland Security Act of 2002, the 

former-U.S. Customs Service, including 


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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 of the Border Patrol and 

transferred into CBP. It is noted that 

certain regulatory authority of the 

United States Customs Service relating 

to customs revenue function was 

retained by the Department of the 

Treasury (see the Department of the 

Treasury Regulatory Plan). In addition 

to its plans to continue issuing 

regulations to enhance border security, 

CBP, during fiscal year 2011, expects to 

continue to issue regulatory documents 

that will facilitate legitimate trade and 

implement trade benefit program. CBP 

regulations regarding the customs 

revenue function are discussed in the 

regulatory plan of the Department of the 

Treasury. 

Federal Emergency Management 

Agency 

The mission of the Federal Emergency 

Management Agency (FEMA) is to 

support our citizens and first responders 

to ensure that, as a Nation, we work 

together to build, sustain, and improve 

our capability to prepare for, protect 

against, respond to, recover from, and 

mitigate all hazards. In fiscal year 2011, 

FEMA will continue to serve that 

mission and promote the Department of 

Homeland Security’s goals. In 

furtherance of the Department and 

Agency’s goals, in the upcoming fiscal 

year, FEMA will be working on 

regulations to implement provisions of 

the Post-Katrina Emergency 

Management Reform Act of 2006 

(PKEMRA) (Pub. L. 109-295, Oct. 4, 

2006), and to implement lessons learned 

from past events. 

Public Assistance Program regulations 

FEMA will work to revise the Public 

Assistance Program regulations in 44 

CFR part 206 to reflect changes made to 

the Robert T. Stafford Disaster Relief 

and Emergency Assistance Act by 

PKEMRA, the Pets Evacuation and 

Transportation Standards Act of 2006 

(PETS Act) (Pub. L. No. 109-308, Oct. 6, 

2006), the Local Community Recovery 

Act of 2006 (Pub. L. No. 109-218, Apr. 

20, 2006), and the Security and 

Accountability for Every Port Act of 

2006 (SAFE Port Act) (Pub. L. No. 109- 

347, Oct. 13, 2006), and to make other 

substantive and nonsubstantive 

clarifications and corrections to the 

Public Assistance regulations. The 

proposed changes would expand 

eligibility to include performing arts 

facilities and community arts centers 

pursuant to section 688 of PKEMRA; 

include education in the list of critical 

services pursuant to section 689(h) of 

PKEMRA, thus allowing private 

nonprofit educational facilities to be 

eligible for restoration funding; add 

accelerated Federal assistance to 

available assistance pursuant to section 

681 of PKEMRA; include household 

pets and service animals in essential 

assistance pursuant to section 689 of 

PKEMRA and section 4 of the PETS Act; 

provide for expedited payments of grant 

assistance for the removal of debris 

pursuant to section 610 of the SAFE 

Port Act; and allow for a contract to be 

set aside for award based on a specific 

geographic area pursuant to section 2 of 

the Local Community Recovery Act of 

2006. Other changes would include 

adding or changing requirements to 

improve and streamline the Public 

Assistance grant application process. 

Federal Law Enforcement Training 

Center 

The Federal Law Enforcement 

Training Center (FLETC) does not have 

any significant regulatory actions 

planned for fiscal year 2011. 

United States Immigration and Customs 

Enforcement 

U.S. Immigration and Customs 

Enforcement (ICE) is the principal 

criminal investigative arm of the 

Department of Homeland Security and 

one of the three Department 

components charged with the civil 

enforcement of the Nation’s immigration 

laws. ICE’s primary mission is to protect 

national security, public safety, and the 

integrity of our borders through the 

criminal and civil enforcement of 

Federal law governing border control, 

customs, trade, and immigration. 

During fiscal year 2011, ICE will 

pursue rulemaking actions that improve 

two critical subject areas: The detention 

of aliens who are subject to final orders 

of removal and the processes for the 

Student and Exchange Visitor Program 

(SEVP). 

Continued Detention of Aliens Subject 

to Final Orders of Removal 

ICE will improve the post order 

custody review process in a final rule 

related to the continued detention of 

aliens subject to final orders of removal 

in light of the U.S. Supreme Court’s 

decisions in Zadvydas v. Davis, 533 U.S. 

678 (2001) and Clark v. Martinez, 543 

U.S. 371 (2005), as well as make 

changes pursuant to the enactment of 

the Homeland Security Act of 2002. 

During fiscal year 2011, ICE will also 

issue a companion notice of proposed 

rulemaking that will allow the public an 

opportunity to comment on new 

sections of the custody determination 

process not previously published for 

comment. 

Processes for the Student and Exchange 

Visitor Program 

ICE will improve SEVP processes by 

publishing a final Optional Practical 

Training (OPT) rule, which will respond 

to comments on the OPT Interim Final 

Rule (IFR) published on June 9, 2008. 

The IFR increased the maximum period 

of OPT from 12 months to 29 months for 

nonimmigrant students who have 

completed a science, technology, 

engineering, or mathematics degree and 

who accept employment with 

employers who participate in USCIS’ EVerify employment verification 

program. 

National Protection and Programs 

Directorate 

The goal of the National Protection 

and Programs Directorate (NPPD) is to 

advance the Department’s risk-reduction 

mission. Reducing risk requires an 

integrated approach that encompasses 

both physical and virtual threats and 

their associated human elements. 

Secure Handling of Ammonium Nitrate 

Program 

The Secure Handling of Ammonium 

Nitrate Act, section 563 of the Fiscal 

Year 2008 Department of Homeland 

Security Appropriations Act, Public 

Law No. 110-161, amended the 

Homeland Security Act of 2002 to 

provide DHS with the authority to 

‘‘regulate the sale and transfer of 

ammonium nitrate by an ammonium 

nitrate facility . . . to prevent the 

misappropriation or use of ammonium 

nitrate in an act of terrorism.’’ 

The Secure Handling of Ammonium 

Nitrate Act directs DHS to promulgate 

regulations requiring potential buyers 

and sellers of ammonium nitrate to 

register with DHS. As part of the 

registration process, the statute directs 

DHS to screen registration applicants 

against the Federal Government’s 

Terrorist Screening Database. The 

statute also requires sellers of 

ammonium nitrate to verify the 

identities of those seeking to purchase 

it; to record certain information about 

each sale or transfer of ammonium 

nitrate; and to report thefts and losses of 

ammonium nitrate to DHS. 

The rule would aid the Federal 

Government in its efforts to prevent the 


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misappropriation of ammonium nitrate 

for use in acts of terrorism. By 

preventing such misappropriation, this 

rule will limit terrorists’ abilities to 

threaten the public and to threaten the 

Nation’s critical infrastructure and key 

resources. By securing the Nation’s 

supply of ammonium nitrate, it will be 

more difficult for terrorists to obtain 

ammonium nitrate materials for use in 

terrorist acts. 

DHS published an advance notice of 

proposed rulemaking (ANPRM) for the 

Secure Handling of Ammonium Nitrate 

Program on October 29, 2008, and has 

received a number of public comments 

on that ANPRM. DHS is presently 

reviewing those comments and is in the 

process of developing a notice of 

proposed rulemaking, which the 

Department hopes to issue during fiscal 

year 2011. 

Collection of Alien Biometric Data Upon 

Exit From the United States at Air and 

Sea Ports of Departure; United States 

Visitor and Immigrant Status Indicator 

Technology Program 

The U.S. Visitor and Immigrant Status 

Indicator Technology (US-VISIT) is an 

integrated, automated entry-exit system 

that records the arrival and departure of 

aliens, verifies aliens’ identities, and 

verifies aliens’ travel documents by 

comparison of biometric identifiers. The 

goals of US-VISIT are to enhance the 

security of U.S. citizens and visitors to 

the United States, facilitate legitimate 

travel and trade, ensure the integrity of 

the U.S. immigration system, and 

protect the privacy of visitors to the 

United States. 

The US-VISIT program, through CBP 

officers or Department of State (DOS) 

consular offices, collects biometrics 

(digital fingerprints and photographs) 

from aliens seeking to enter the United 

States. DHS checks that information 

against government databases to identify 

suspected terrorists, known criminals, 

or individuals who have previously 

violated U.S. immigration laws. This 

system assists DHS and DOS in 

determining whether an alien seeking to 

enter the United States is, in fact, 

admissible to the United States under 

existing law. No biometric exit system 

currently exists, however, to assist DHS 

or DOS in determining whether an alien 

has overstayed the terms of his or her 

visa or other authorization to be present 

in the United States. 

NPPD published a notice of proposed 

rulemaking on April 24, 2008, 

proposing to establish an exit program 

at all air and sea ports of departure in 

the United States. Congress 

subsequently enacted the Consolidated 

Security, Disaster Assistance, and 

Continuing Appropriations Act of 2009, 

Public Law No.110-329 (Sep. 30, 2008), 

requiring DHS to delay issuance of a 

final rule until the conclusion of pilot 

tests to analyze the collection of 

biometrics from at least two air exit 

scenarios. DHS currently is reviewing 

the results of those tests. DHS continues 

to work to ensure that the final air/sea 

exit rule will be issued as soon as 

practicable. 

Transportation Security Administration 

The Transportation Security 

Administration (TSA) protects the 

Nation’s transportation systems to 

ensure freedom of movement for people 

and commerce. TSA is committed to 

continuously setting the standard for 

excellence in transportation security 

through its people, processes, and 

technology as we work to meet the 

immediate and long-term needs of the 

transportation sector. 

In fiscal year 2011, TSA will promote 

the DHS mission by emphasizing 

regulatory efforts that allow TSA to 

better identify, detect, and protect 

against threats against various modes of 

the transportation system, while 

facilitating the efficient movement of 

the traveling public, transportation 

workers, and cargo. 

Screening of Air Cargo 

TSA will finalize an interim final rule 

that codifies a statutory requirement of 

the Implementing Recommendations of 

the 9/11 Commission Act of 2008 (9/11 

Act), Public Law 110-53 (Aug. 3, 2007) 

that TSA establish a system to screen 

100 percent of cargo transported on 

passenger aircraft by August 3, 2010. To 

assist in carrying out this mandate, TSA 

has established a voluntary program 

under which it certifies cargo screening 

facilities to screen cargo according to 

TSA standards prior to its being 

tendered to aircraft operators for 

carriage on passenger aircraft. 

Large Aircraft Security Program 

(General Aviation) 

TSA plans to issue a supplemental 

notice of proposed rulemaking (SNPRM) 

to propose amendments to current 

aviation transportation security 

regulations to enhance the security of 

general aviation (GA) by expanding the 

scope of current requirements and by 

adding new requirements for certain GA 

aircraft operators. To date, the 

Government’s focus with regard to 

aviation security generally has been on 

air carriers and commercial operators. 

As vulnerabilities and risks associated 

with air carriers and commercial 

operators have been reduced or 

mitigated, terrorists may perceive that 

GA aircraft are more vulnerable and 

may view them as attractive targets. 

This rule would enhance aviation 

security of certain GA aircraft to 

undertake other security measures. TSA 

published a notice of proposed 

rulemaking on October 30, 2008, and 

received over 7,000 public comments, 

generally urging significant changes to 

the proposal. The SNPRM will respond 

to the comments and contain proposals 

on addressing security in the GA sector. 

Security Training for Surface Mode 

Employees 

TSA will propose regulations to 

enhance the security of several nonaviation modes of transportation. In 

particular, TSA will propose regulations 

requiring freight railroad carriers, public 

transportation agencies (including rail 

mass transit and bus systems), passenger 

railroad carriers, over-the-road bus 

operators, and motor carriers 

transporting certain hazardous materials 

to conduct security training for front 

line employees. This regulation would 

implement sections 1408 (Public 

Transportation), 1517 (Freight 

Railroads), and 1534(a) (Over the Road 

(OTR) Buses) of the 9/11 Act. The 

NPRM will define which employees 

must be trained under these provisions, 

in compliance with the definitions of 

frontline employees in the pertinent 

provisions of the 9/11 Act. Some parts 

of the proposed rule would extend 

beyond the requirements of the 9/11 

Act; those portions are authorized by 

the Aviation and Transportation 

Security Act. 

Aircraft Repair Station Security. 

TSA will finalize a rule requiring 

repair stations that are certificated by 

the Federal Aviation Administration 

under 14 CFR part 145 to adopt and 

implement standard security programs 

and to comply with security directives 

issued by TSA. TSA issued a notice of 

proposed rulemaking on November 18, 

2009. The final rule will also codify the 

scope of TSA’s existing inspection 

program and require regulated parties to 

allow DHS officials to enter, inspect, 

and test property, facilities, and records 

relevant to repair stations. This 

rulemaking action implements section 

1616 of the 9/11 Act. 

Standardized Vetting, Adjudication, 

and Redress Process and Fees 

TSA is developing a proposed rule to 

revise and standardize the procedures, 

adjudication criteria, and fees for most 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79542 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

of the security threat assessments (STA) 

of individuals that TSA conducts. The 

scope of the rulemaking will include 

transportation workers from almost all 

modes of transportation who are 

required to undergo an STA by a 

regulatory program and new programs, 

including those covered under the 9/11 

Act. In addition, TSA will propose 

equitable fees to cover the cost of the 

STAs and credentials for some 

personnel. TSA plans to identify new 

efficiencies in processing STAs and 

ways to streamline existing regulations 

by simplifying language and removing 

redundancies. 

United States Secret Service 

The United States Secret Service does 

not have any significant regulatory 

actions planned for fiscal year 2011. 

DHS Regulatory Plan for Fiscal Year 

2011 

A more detailed description of the 

priority regulations that comprise DHS’ 

fall 2010 regulatory plan follows. 

DHS—Office of the Secretary (OS) 

PROPOSED RULE STAGE 

61. SECURE HANDLING OF 

AMMONIUM NITRATE PROGRAM 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Legal Authority: 

sec 563 of the 2008 Consolidated 

Appropriations Act, subtitle J—Secure 

Handling of Ammonium Nitrate, PL 

110–161 

CFR Citation: 

6 CFR 31 

Legal Deadline: 

NPRM, Statutory, May 26, 2008, 

Publication of Notice of Proposed 

Rulemaking. 

Abstract: 

This rulemaking will implement the 

December 2007 amendment to the 

Homeland Security Act entitled 

‘‘Secure Handling of Ammonium 

Nitrate.’’ The amendment requires the 

Department of Homeland Security to 

‘‘regulate the sale and transfer of 

ammonium nitrate by an ammonium 

nitrate facility. . .to prevent the 

misappropriation or use of ammonium 

nitrate in an act of terrorism.’’ 

Statement of Need: 

Pursuant to section 563 of the 2008 

Consolidated Appropriations Act, the 

Secure Handling of Ammonium Nitrate 

Act, Public Law 110-161, the 

Department of Homeland Security is 

required to promulgate a rulemaking to 

create a registration regime for certain 

buyers and sellers of ammonium 

nitrate. The rule, as proposed by this 

NPRM, would create that regime, and 

will aid the Federal Government in its 

efforts to prevent the misappropriation 

of ammonium nitrate for use in acts 

of terrorism. By preventing such 

misappropriation, this rule would limit 

terrorists’ abilities to threaten the 

public and to threaten the Nation’s 

critical infrastructure and key 

resources. By securing the Nation’s 

supply of ammonium nitrate, it would 

be much more difficult for terrorists to 

obtain ammonium nitrate materials for 

use in improvised explosive devices. 

As a result, there is a direct value in 

the deterrence of a catastrophic terrorist 

attack using ammonium nitrate, such as 

the Oklahoma City attack that killed 

over 160, injured 853 people, and is 

estimated to have caused $652 million 

in damages ($921 million in 2009). 

Summary of Legal Basis: 

Section 563 of the 2008 Consolidated 

Appropriations Act, subtitle J— Secure 

Handling of Ammonium Nitrate, Public 

Law 110-161, authorizes and requires 

this rulemaking. 

Alternatives: 

The Department of Homeland Security 

is required by statute to publish 

regulations implementing the Secure 

Handling of Ammonium Nitrate Act. As 

part of its notice of proposed 

rulemaking, the Department will seek 

public comment on the numerous 

alternative ways in which the final 

Secure Handling of Ammonium Nitrate 

Program could carry out the 

requirements of the Secure Handling of 

Ammonium Nitrate Act. 

Anticipated Cost and Benefits: 

A proposed rule registering certain 

buyers and sellers of ammonium nitrate 

would have costs to ammonium nitrate 

(AN) purchasers, including farms, 

fertilizer mixers, farm supply 

wholesalers and coops, golf courses, 

landscaping services, explosives 

distributors, mines, retail garden 

centers, and lab supply wholesalers. 

There would also be costs to AN 

sellers, such as ammonium nitrate 

fertilizer and explosive manufacturers, 

fertilizer mixers, farm supply 

wholesalers and coops, retail garden 

center, explosives distributors, fertilizer 

applicator services, and lab supply 

wholesalers. Costs will relate to the 

point of sale requirements, registration 

activities, recordkeeping, 

inspections/audits, and reporting of 

theft or loss. 

Because the value of the benefits of 

reducing risk of a terrorist attack is a 

function of both the probability of an 

attack and the value of the 

consequence, it is difficult to identify 

the particular risk reduction associated 

with the implementation of this rule. 

When the proposed rule is published, 

DHS will provide a break even analysis. 

The program elements that would help 

achieve the risk reductions will be 

discussed in the break even analysis. 

These elements and related qualitative 

benefits include point of sale 

identification requirements and 

requiring individuals to be screened 

against the TSDB resulting in known 

bad actors being denied the ability to 

purchase ammonium nitrate. 

Risks: 

Explosives containing ammonium 

nitrate are commonly used in terrorist 

attacks. Such attacks have been carried 

out both domestically and 

internationally. The 1995 Murrah 

Federal Building attack in Oklahoma 

City claimed the lives of 167 

individuals and demonstrated firsthand 

to America how ammonium nitrate 

could be misused by terrorists. In 

addition to the Murrah Building attack, 

the Provisional Irish Republican Army 

used ammonium nitrate as part of its 

London, England bombing campaign in 

the early 1980s. More recently, 

ammonium nitrate was used in the 

1998 East African Embassy bombings 

and in November 2003 bombings in 

Istanbul, Turkey. Additionally, since 

the events of 9/11, stores of ammonium 

nitrate have been confiscated during 

raids on terrorist sites around the 

world, including sites in Canada, 

England, India, and the Philippines. 

The Department of Homeland Security 

aims to prevent terrorist attacks within 

the United States and to reduce the 

vulnerability of the United States to 

terrorism. By preventing the 

misappropriation or use of ammonium 

nitrate in acts of terrorism, this 

rulemaking will support the 

Department’s efforts to prevent terrorist 

attacks and to reduce the Nation’s 

vulnerability to terrorist attacks. This 

rulemaking is complementary to other 

Department programs seeking to reduce 

the risks posed by terrorism, including 

the Chemical Facility Anti-Terrorism 


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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79543 

Standards program (which seeks in part 

to prevent terrorists from gaining access 

to dangerous chemicals) and the 

Transportation Worker Identification 

Credential program (which seeks in 

part to prevent terrorists from gaining 

access to certain critical infrastructure), 

among other programs. 

Timetable: 

Action Date FR Cite 

ANPRM 10/29/08 73 FR 64280 

Correction 11/05/08 73 FR 65783 

ANPRM Comment 

Period End 

12/29/08 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Federal 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Todd Klessman 

Acting Deputy Director, Infrastructure 

Security Compliance Division 

Department of Homeland Security 

Ballston 1 – 5th floor 

Room 5030 

Arlington, VA 22201 

Phone: 703 235–4921 

Email: todd.klessman@dhs.gov 

RIN: 1601–AA52 

DHS—OS 

FINAL RULE STAGE 

62. COLLECTION OF ALIEN 

BIOMETRIC DATA UPON EXIT FROM 

THE UNITED STATES AT AIR AND 

SEA PORTS OF DEPARTURE; UNITED 

STATES VISITOR AND IMMIGRANT 

STATUS INDICATOR TECHNOLOGY 

PROGRAM (US–VISIT) 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

8 USC 1101 to 1104; 8 USC 1182; 8 

USC 1184 to 1185 (pursuant to EO 

13323); 8 USC 1221; 8 USC 1365a, 

1365b; 8 USC 1379; 8 USC 1731 to 

1732 

CFR Citation: 

8 CFR 215.1; 8 CFR 215.8 

Legal Deadline: 

None 

Abstract: 

DHS established the United States 

Visitor and Immigrant Status Indicator 

Technology Program (US-VISIT) in 

accordance with a series of legislative 

mandates requiring that DHS create an 

integrated automated entry-exit system 

that records the arrival and departure 

of aliens; verifies aliens’ identities; and 

authenticates travel documents. This 

rule requires aliens to provide 

biometric identifiers at entry and upon 

departure at any air and sea port of 

entry at which facilities exist to collect 

such information. 

Statement of Need: 

This rule establishes an exit system at 

all air and sea ports of departure in 

the United States. This rule requires 

aliens subject to United States Visitor 

and Immigrant Status Indicator 

Technology Program biometric 

requirements upon entering the United 

States to also provide biometric 

identifiers prior to departing the United 

States from air or sea ports of 

departure. 

Alternatives: 

The proposed rule would require aliens 

who are subject to US-VISIT biometric 

requirements upon entering the United 

States to provide biometric information 

before departing from the United States 

at air and sea ports of entry. The rule 

proposed a performance standard for 

commercial air and vessel carriers to 

collect the biometric information and 

to submit this information to DHS no 

later than 24 hours after air carrier staff 

secure the aircraft doors on an 

international departure, or for sea 

travel, no later than 24 hours after the 

vessel’s departure from a U.S. port. 

DHS is considering numerous 

alternatives based upon public 

comment on the alternatives in the 

NPRM. Alternatives included various 

points in the process, kiosks, and 

varying levels of responsibility for the 

carriers and government. DHS may 

select another variation between the 

outer bounds of the alternatives 

presented or another alternative if 

subsequent analysis warrants. 

Anticipated Cost and Benefits: 

The proposed rule expenditure and 

delay costs for a 10-year period are 

estimated at $3.5 billion. Alternative 

costs range from $3.1 billion to $6.4 

billion. US-VISIT assessed seven 

categories of economic impacts other 

than direct expenditures. Of these, two 

are economic costs: Social costs 

resulting from increased traveler queue 

and processing time; and social costs 

resulting from increased flight delays. 

Ten-year benefits are estimated at $1.1 

billion. US-VISIT assessed seven 

categories of economic impacts other 

than direct expenditures. Of these, five 

are benefits, which include costs that 

could be avoided for each alternative: 

Cost avoidance resulting from improved 

detection of aliens overstaying visas; 

cost avoidance resulting from improved 

U.S. Immigrations and Customs 

Enforcement (ICE) efficiency attempting 

apprehension of overstays; cost 

avoidance resulting from improved 

efficiency processing exit/entry data; 

improved compliance with NSEERS 

requirements due to the improvement 

in ease of compliance; and improved 

national security environment. These 

benefits are measured quantitatively or 

qualitatively. 

Timetable: 

Action Date FR Cite 

NPRM 04/24/08 73 FR 22065 

NPRM Comment 

Period End 

06/23/08 

Final Rule 04/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79544 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Agency Contact: 

Long D. Kaiser 

Policy Analyst, National Protection and 

Programs Directorate (NPPD), US–VISIT 

Department of Homeland Security 

Washington, DC 20528 

Phone: 202 295–0735 

Email: long.d.kaiser@dhs.gov 

Related RIN: Previously reported as 

1650–AA04 

RIN: 1601–AA34 

DHS—U.S. Citizenship and 

Immigration Services (USCIS) 

PROPOSED RULE STAGE 

63. ASYLUM AND WITHHOLDING 

DEFINITIONS 

Priority: 

Other Significant 

Legal Authority: 

8 USC 1103; 8 USC 1158; 8 USC 1226; 

8 USC 1252; 8 USC 1282; 8 CFR 2 

CFR Citation: 

8 CFR 208 

Legal Deadline: 

None 

Abstract: 

This rule proposes to amend 

Department of Homeland Security 

regulations that govern asylum 

eligibility. The amendments focus on 

portions of the regulations that deal 

with the definitions of membership in 

a particular social group, the 

requirements for failure of State 

protection, and determinations about 

whether persecution is inflicted on 

account of a protected ground. This 

rule codifies long-standing concepts of 

the definitions. It clarifies that gender 

can be a basis for membership in a 

particular social group. It also clarifies 

that a person who has suffered or fears 

domestic violence may under certain 

circumstances be eligible for asylum on 

that basis. After the Board of 

Immigration Appeals published a 

decision on this issue in 1999, Matter 

of R-A-, Int. Dec. 3403 (BIA 1999), it 

became clear that the governing 

regulatory standards required 

clarification. The Department of Justice 

began this regulatory initiative by 

publishing a proposed rule addressing 

these issues in 2000. 

Statement of Need: 

This rule provides guidance on a 

number of key interpretive issues of the 

refugee definition used by adjudicators 

deciding asylum and withholding of 

removal (withholding) claims. The 

interpretive issues include whether 

persecution is inflicted on account of 

a protected ground, the requirements 

for establishing the failure of State 

protection, and the parameters for 

defining membership in a particular 

social group. This rule will aid in the 

adjudication of claims made by 

applicants whose claims fall outside of 

the rubric of the protected grounds of 

race, religion, nationality, or political 

opinion. One example of such claims 

which often fall within the particular 

social group ground concerns people 

who have suffered or fear domestic 

violence. This rule is expected to 

consolidate issues raised in a proposed 

rule in 2000, and to address issues that 

have developed since the publication 

of the proposed rule. This should 

provide greater stability and clarity in 

this important area of the law. 

Summary of Legal Basis: 

The purpose of this rule is to provide 

guidance on certain issues that have 

arisen in the context of asylum and 

withholding adjudications. The 1951 

Geneva Convention relating to the 

Status of Refugees (1951 Convention) 

contains the internationally accepted 

definition of a refugee. United States 

immigration law incorporates an almost 

identical definition of a refugee as a 

person outside his or her country of 

origin ‘‘who is unable or unwilling to 

return to, and is unable or unwilling 

to avail himself or herself of the 

protection of, that country because of 

persecution or a well-founded fear of 

persecution on account of race, 

religion, nationality, membership in a 

particular social group, or political 

opinion.‘‘ Section 101(a)(42) of the 

Immigration and Nationality Act. 

Alternatives: 

A sizable body of interpretive case law 

has developed around the meaning of 

the refugee definition. Historically, 

much of this case law has addressed 

more traditional asylum and 

withholding claims based on the 

protected grounds of race, religion, 

nationality, or political opinion. In 

recent years, however, the United 

States increasingly has encountered 

asylum and withholding applications 

with more varied bases, related, for 

example, to an applicant’s gender or 

sexual orientation. Many of these new 

types of claims are based on the ground 

of ‘‘membership in a particular social 

group,’’ which is the least well-defined 

of the five protected grounds within the 

refugee definition. 

On December 7, 2000, a proposed rule 

was published in the Federal Register 

providing guidance on the definitions 

of ‘‘persecution’’ and ‘‘membership in 

a particular social group.’’ Prior to 

publishing a final rule, the Department 

will be considering how the nexus 

between persecution and a protected 

ground might be further 

conceptualized; how membership in a 

particular social group might be 

defined and evaluated; and what 

constitutes a State’s inability or 

unwillingness to protect the applicant 

where the persecution arises from a 

non-State actor. This rule will provide 

guidance to the following adjudicators: 

USCIS asylum officers, Department of 

Justice Executive Office for Immigration 

Review (EOIR) immigration judges, and 

members of the EOIR Board of 

Immigration Appeals. The alternative to 

publishing this rule would be to allow 

the standards governing this area of law 

to continue to develop piecemeal 

through administrative and judicial 

precedent. This approach has resulted 

in inconsistent and confusing 

standards, and the Department has 

therefore determined that promulgation 

of the final rule is necessary. 

Anticipated Cost and Benefits: 

By providing a clear framework for key 

asylum and withholding issues, we 

anticipate that adjudicators will have 

clear guidance, increasing 

administrative efficiency, and 

consistency in adjudicating these cases. 

The rule will also promote a more 

consistent and predictable body of 

administrative and judicial precedent 

governing these types of cases. We 

anticipate that this will enable 

applicants to better assess their 

potential eligibility for asylum, and to 

present their claims more efficiently 

when they believe that they may 

qualify, thus reducing the resources 

spent on adjudicating claims that do 

not qualify. In addition, a more 

consistent and predictable body of law 

on these issues will likely result in 

fewer appeals, both administrative and 

judicial, and reduce the associated 

litigation costs. The Department has no 

way of accurately predicting how this 

rule will impact the number of asylum 

applications filed in the United States. 

Based on anecdotal evidence and on 

the reported experience of other nations 

that have adopted standards under 

which the results are similar to those 

we anticipate from this rule, we do not 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79545 

believe this rule will cause a large 

change in the number of asylum 

applications filed. 

Risks: 

The failure to promulgate a final rule 

in this area presents significant risks 

of further inconsistency and confusion 

in the law. The Government’s interests 

in fair, efficient and consistent 

adjudications would be compromised. 

Timetable: 

Action Date FR Cite 

NPRM 12/07/00 65 FR 76588 

NPRM Comment 

Period End 

01/22/01 

NPRM 03/00/11 

NPRM Comment 

Period End 

05/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Additional Information: 

CIS No. 2092-00 

Transferred from RIN 1115-AF92 

Agency Contact: 

Jedidah Hussey 

Deputy Chief, Asylum Division 

Department of Homeland Security 

U.S. Citizenship and Immigration 

Services 

Suite 3300, 20 Massachusetts Avenue 

NW. 

Washington, DC 20529 

Phone: 202 272–1663 

Email: jedidah.m.hussey@dhs.gov 

RIN: 1615–AA41 

DHS—USCIS 

64. REGISTRATION REQUIREMENT 

FOR PETITIONERS SEEKING TO FILE 

H–1B PETITIONS ON BEHALF OF 

ALIENS SUBJECT TO NUMERICAL 

LIMITATIONS 

Priority: 

Other Significant 

Legal Authority: 

8 USC 1184(g) 

CFR Citation: 

8 CFR 103; 8 CFR 299 

Legal Deadline: 

None 

Abstract: 

The Department of Homeland Security 

is proposing to amend its regulations 

governing petitions filed on behalf of 

alien workers subject to annual 

numerical limitations. This rule 

proposes an electronic registration 

program for petitions subject to 

numerical limitations contained in the 

Immigration and Nationality Act (the 

Act). Initially, the program would be 

for the H-1B nonimmigrant 

classification; however, other 

nonimmigrant classifications will be 

added as needed. This action is 

necessary because the demand for H1B specialty occupation workers by 

U.S. companies generally exceeds the 

numerical limitation. This rule is 

intended to allow USCIS to more 

efficiently manage the intake and 

lottery process for these H-1B petitions. 

Statement of Need: 

U.S. Citizenship and Immigration 

Services (USCIS) proposes to establish 

a mandatory Internet-based electronic 

registration process for U.S. employers 

seeking to file H-1B petitions for alien 

workers subject to either the 65,000 or 

20,000 caps. This registration process 

would allow U.S. employers to 

electronically register for consideration 

of available H-1B cap numbers. The 

mandatory proposed registration 

process will alleviate administrative 

burdens on USCIS service centers and 

eliminate the need for U.S. employers 

to needlessly prepare and file H-1B 

petitions without any certainty that an 

H-1B cap number will ultimately be 

allocated to the beneficiary named on 

that petition. 

Summary of Legal Basis: 

Section 214(g) of the Immigration and 

Nationality Act provides limits on the 

number of alien temporary workers 

who may be granted H-1B 

nonimmigrant status each fiscal year 

(commonly known as the ‘‘cap’’). 

USCIS has responsibility for monitoring 

the requests for H-1B workers and 

administers the distribution of available 

H-1B cap numbers in light of these 

limits. 

Alternatives: 

To ensure a fair and orderly 

distribution of H-1B cap numbers, 

USCIS evaluated its current random 

selection process, and has found that 

when it receives a significant number 

of H-1B petitions within the first few 

days of the H-1B filing period, it is 

extremely difficult to handle the 

volume of petitions received in advance 

of the H-1B random selection process. 

Further, the current petition process of 

preparing and mailing H-1B petitions, 

with the required filing fee, can be 

burdensome and costly for employers, 

if the petition is returned because the 

cap was reached and the petition was 

not selected in the random selection 

process. 

Accordingly, this rule proposes to 

implement a new process to allow U.S. 

employers to electronically register for 

consideration of available H-1B cap 

numbers without having to first prepare 

and submit the petition. 

Anticipated Cost and Benefits: 

USCIS estimates that this rule will 

result in a net benefit to society. 

Currently, employers submit a petition, 

at great expense, without any certainty 

that an H-1B cap number will 

ultimately be allocated to the 

beneficiary named on the petition. The 

new mandatory, Internet-based 

registration system allows employers to 

complete a much shorter and less 

expensive registration process for 

consideration of available H-1B cap 

numbers. The new system will also 

relieve a significant administrative 

burden and expense from USCIS. 

This rule will reduce costs for some 

employers and increase them for others. 

For employers that are not allocated a 

cap number and therefore do not 

ultimately file a petition, there will be 

a significant cost savings. Employers 

that are allocated a cap number and 

ultimately file a petition will 

experience the new and additional cost 

of filing the registration. Additionally, 

USCIS will incur additional costs to 

implement and maintain the 

registration system. USCIS has weighed 

the benefits and costs associated with 

this rule and determined that the 

benefits to society outweigh the costs. 

Risks: 

There is a risk that a petitioner will 

submit multiple petitions for the same 

H-1B beneficiary so that the U.S. 

employer will have a better chance of 

his or her petition being selected. 

Accordingly, should USCIS receive 

multiple petitions for the same H-1B 

beneficiary by the same petitioner, the 

system will only accept the first 

petition and reject the duplicate 

petitions. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

NPRM Comment 

Period End 

03/00/11 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79546 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Additional Information: 

USCIS 2443-08 

Agency Contact: 

Claudia F. Young 

Department of Homeland Security 

U.S. Citizenship and Immigration 

Services 

Service Center Operations 

20 Massachusetts Avenue NW. 

Washington, DC 20529 

Phone: 202 272–8163 

Email: cf1young@dhs.gov 

RIN: 1615–AB71 

DHS—USCIS 

65. ∑ EXCEPTION TO THE 

PERSECUTION BAR FOR ASYLUM, 

REFUGEE, AND TEMPORARY 

PROTECTED STATUS, AND 

WITHHOLDING OF REMOVAL 

Priority: 

Other Significant 

Legal Authority: 

8 USC 1101; 8 USC 1103; 8 USC 1158; 

8 USC 1226; PL 107–26; PL 110–229; 

. . . 

CFR Citation: 

8 CFR 1; 8 CFR 208; 8 CFR 244; 8 

CFR 1244; . . . 

Legal Deadline: 

None 

Abstract: 

This joint rule proposes amendments to 

Department of Homeland Security 

(DHS) and Department of Justice (DOJ) 

regulations to describe the 

circumstances under which an 

applicant will continue to be eligible 

for asylum, refugee, or temporary 

protected status, special rule 

cancellation of removal under the 

Nicaraguan Adjustment and Central 

American Relief Act, and withholding 

of removal, even if DHS or DOJ has 

determined that the applicant’s actions 

contributed, in some way, to the 

persecution of others. The purpose of 

this rule is to resolve ambiguity in the 

statutory language precluding eligibility 

for asylum, refugee, and temporary 

protected status of an applicant who 

ordered, incited, assisted, or otherwise 

participated in the persecution of 

others. The proposed amendment 

would provide a limited exception for 

actions taken by the applicant under 

duress and clarify the required levels 

of the applicant’s knowledge of the 

persecution. 

Statement of Need: 

This rule resolves ambiguity in the 

statutory language precluding eligibility 

for asylum, refugee, and temporary 

protected status of an applicant who 

ordered, incited, assisted, or otherwise 

participated in the persecution of 

others. The proposed amendment 

would provide a limited exception for 

actions taken by the applicant under 

duress and clarify the required levels 

of the applicant’s knowledge of the 

persecution. 

Summary of Legal Basis: 

In Negusie v. Holder, 129 S. Ct. 1159 

(2009), the Supreme Court addressed 

whether the persecutor bar should 

apply where an alien’s actions were 

taken under duress. DHS believe that 

this is an appropriate subject for 

rulemaking and propose to amend the 

applicable regulations to set out their 

interpretation of the statute. In 

developing this regulatory initiative, 

DHS has carefully considered the 

purpose and history behind enactment 

of the persecutor bar, including its 

international law origins and the 

criminal law concepts upon which they 

are based. 

Alternatives: 

DHS did consider the alternative of not 

publishing a rulemaking on these 

issues. To leave this important area of 

the law without an administrative 

interpretation, however, would confuse 

adjudicators and the public. 

Anticipated Cost and Benefits: 

The programs affected by this rule exist 

so that the United States may respond 

effectively to global humanitarian 

situations and assist people who are in 

need. USCIS provides a number of 

humanitarian programs and protection 

to assist individuals in need of shelter 

or aid from disasters, oppression, 

emergency medical issues, and other 

urgent circumstances. This rule will 

advance the humanitarian goals of the 

asylum/refugee program, and other 

specialized programs. The main 

benefits of such tend to be intangible 

and difficult to quantify in economic 

and monetary terms. These forms of 

relief have not been available to certain 

persecutors. This rule will allow an 

exception to this bar from protection 

for applicants who can meet the 

appropriate evidentiary standard. 

Consequently, this rule may result in 

a small increase in the number of 

applicants for humanitarian programs. 

To the extent a small increase in 

applicants occurs, there could be 

additional fee costs incurred by these 

applicants. 

Risks: 

If DHS were not to publish a regulation, 

the public would face a lengthy period 

of confusion on these issues. There 

could also be inconsistent 

interpretations of the statutory 

language, leading to significant 

litigation and delay for the affected 

public. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Agency Contact: 

Molly Groom 

Office of the Chief Counsel 

Department of Homeland Security 

U.S. Citizenship and Immigration 

Services 

20 Massachusetts Avenue NW. 

Washington, DC 20259 

Phone: 202 272–1400 

Fax: 202 272–1408 

Email: molly.groom@dhs.gov 

RIN: 1615–AB89 

DHS—USCIS 

FINAL RULE STAGE 

66. NEW CLASSIFICATION FOR 

VICTIMS OF SEVERE FORMS OF 

TRAFFICKING IN PERSONS; 

ELIGIBILITY FOR T NONIMMIGRANT 

STATUS 

Priority: 

Other Significant 

Legal Authority: 

5 USC 552; 5 USC 552a; 8 USC 1101 

to 1104; 8 USC 1182; 8 USC 1184; 8 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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USC 1187; 8 USC 1201; 8 USC 1224 

to 1227; 8 USC 1252 to 1252a; 22 USC 

7101; 22 USC 7105; . . . 

CFR Citation: 

8 CFR 103; 8 CFR 212; 8 CFR 214; 8 

CFR 274a; 8 CFR 299 

Legal Deadline: 

None 

Abstract: 

T classification was created by 107(e) 

of the Victims of Trafficking and 

Violence Protection Act of 2000 

(VTVPA), Public Law 106-386. The T 

nonimmigrant classification was 

designed for eligible victims of severe 

forms of trafficking in persons who aid 

law enforcement with their 

investigation or prosecution of the 

traffickers, and who can establish that 

they would suffer extreme hardship 

involving unusual and severe harm if 

they were removed from the United 

States. The rule establishes application 

procedures and responsibilities for the 

Department of Homeland Security and 

provides guidance to the public on how 

to meet certain requirements to obtain 

T nonimmigrant status. The Trafficking 

Victims Protection Reauthorization Act 

of 2008, Public Law 110-457, made 

amendments to the T nonimmigrant 

status provisions of the Immigration 

and Naturalization Act. The 

Department will issue another interim 

final rule to make the changes required 

by recent legislation and to provide the 

opportunity for notice and comment. 

Statement of Need: 

T nonimmigrant status is available to 

eligible victims of severe forms of 

trafficking in persons who have 

complied with any reasonable request 

for assistance in the investigation or 

prosecution of acts of trafficking in 

persons, and who can demonstrate that 

they would suffer extreme hardship 

involving unusual and severe harm if 

removed from the United States. This 

rule addresses the essential elements 

that must be demonstrated for 

classification as a T nonimmigrant 

alien; the procedures to be followed by 

applicants to apply for T nonimmigrant 

status; and evidentiary guidance to 

assist in the application process. 

Summary of Legal Basis: 

Section 107(e) of the Trafficking 

Victims Protection Act (TVPA), Public 

Law 106-386, as amended, established 

the T classification to create a safe 

haven for certain eligible victims of 

severe forms of trafficking in persons, 

who assist law enforcement authorities 

in investigating and prosecuting the 

perpetrators of these crimes. 

Alternatives: 

To develop a comprehensive Federal 

approach to identifying victims of 

severe forms of trafficking in persons, 

to provide them with benefits and 

services, and to enhance the 

Department of Justice’s ability to 

prosecute traffickers and prevent 

trafficking in persons in the first place, 

a series of meetings with stakeholders 

were conducted with representatives 

from key Federal agencies; national, 

State, and local law enforcement 

associations; non-profit, communitybased victim rights organizations; and 

other groups. Suggestions from these 

stakeholders were used in the drafting 

of this regulation. 

Anticipated Cost and Benefits: 

There is no cost to applicants 

associated with this regulation. 

Applicants for T nonimmigrant status 

do not pay application or biometric 

fees. 

The anticipated benefits of these 

expenditures include: Assistance to 

trafficked victims and their families, 

prosecution of traffickers in persons, 

and the elimination of abuses caused 

by trafficking activities. 

Benefits which may be attributed to the 

implementation of this rule are 

expected to be: 

1. An increase in the number of cases 

brought forward for investigation 

and/or prosecution; 

2. Heightened awareness by the law 

enforcement community of trafficking 

in persons; 

3. Enhanced ability to develop and 

work cases in trafficking in persons 

cross-organizationally and multijurisdictionally, which may begin to 

influence changes in trafficking 

patterns. 

Risks: 

There is a 5,000-person limit to the 

number of individuals who can be 

granted T-1 status per fiscal year. 

Eligible applicants who are not granted 

T-1 status due solely to the numerical 

limit will be placed on a waiting list 

to be maintained by U.S. Citizenship 

and Immigration Services (USCIS). 

To protect T-1 applicants and their 

families, USCIS will use various means 

to prevent the removal of T-1 

applicants on the waiting list, and their 

family members who are eligible for 

derivative T status, including its 

existing authority to grant deferred 

action, parole, and stays of removal. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 01/31/02 67 FR 4784 

Interim Final Rule 

Effective 

03/04/02 

Interim Final Rule 

Comment Period 

End 

04/01/02 

Interim Final Rule 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses, Governmental Jurisdictions, 

Organizations 

Government Levels Affected: 

Federal, Local, State 

Additional Information: 

CIS No. 2132-01; AG Order No. 2554- 

2002 

There is a related rulemaking, CIS No. 

2170-01, the new U nonimmigrant 

status (RIN 1615-AA67). 

Transferred from RIN 1115-AG19 

Agency Contact: 

Laura M. Dawkins 

Chief, Family Immigration and Victim 

Protection Division 

Department of Homeland Security 

U.S. Citizenship and Immigration 

Services 

20 Massachusetts Avenue NW. 

Suite 1200 

Washington, DC 20529 

Phone: 202 272–1470 

Fax: 202 272–1480 

Email: laura.dawkins@dhs.gov 

RIN: 1615–AA59 

DHS—USCIS 

67. ADJUSTMENT OF STATUS TO 

LAWFUL PERMANENT RESIDENT 

FOR ALIENS IN T AND U 

NONIMMIGRANT STATUS 

Priority: 

Other Significant 

Legal Authority: 

5 USC 552; 5 USC 552a; 8 USC 1101 

to 1104; 8 USC 1182; 8 USC 1184; 8 

USC 1187; 8 USC 1201; 8 USC 1224 

to 1227; 8 USC 1252 to 1252a; 8 USC 

1255; 22 USC 7101; 22 USC 7105 

CFR Citation: 

8 CFR 204; 8 CFR 214; 8 CFR 245 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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Legal Deadline: 

None 

Abstract: 

This rule sets forth measures by which 

certain victims of severe forms of 

trafficking who have been granted T 

nonimmigrant status and victims of 

certain criminal activity who have been 

granted U nonimmigrant status may 

apply for adjustment to permanent 

resident status in accordance with 

Public Law 106-386, Victims of 

Trafficking and Violence Protection Act 

of 2000; and Public Law 109-162, 

Violence Against Women and 

Department of Justice Reauthorization 

Act of 2005. The Trafficking Victims 

Protection Reauthorization Act of 2008, 

Public Law 110-457, made amendments 

to the T nonimmigrant status 

provisions of the Immigration and 

Naturalization Act. The Department 

will issue another interim final rule to 

make the changes required by recent 

legislation and to provide the 

opportunity for notice and comment. 

Statement of Need: 

This regulation is necessary to permit 

aliens in lawful T or U nonimmigrant 

status to apply for adjustment of status 

to that of lawful permanent residents. 

T nonimmigrant status is available to 

aliens who are victims of a severe form 

of trafficking in persons and who are 

assisting law enforcement in the 

investigation or prosecution of the acts 

of trafficking. U nonimmigrant status is 

available to aliens who are victims of 

certain crimes and are being helpful to 

the investigation or prosecution of 

those crimes. 

Summary of Legal Basis: 

This rule implements the Victims of 

Trafficking and Violence Protection Act 

of 2000 (VTVPA), Public Law 106-386, 

114 Stat. 1464 (Oct. 28, 2000), as 

amended, to permit aliens in lawful T 

or U nonimmigrant status to apply for 

adjustment of status to that of lawful 

permanent residents. 

Alternatives: 

USCIS did not consider alternatives to 

managing T and U applications for 

adjustment of status. Ease of 

administration dictates that adjustment 

of status applications from T and U 

nonimmigrants would be best handled 

on a first in, first out basis, because 

that is the way applications for T and 

U status are currently handled. 

Anticipated Cost and Benefits: 

USCIS uses fees to fund the cost of 

processing applications and associated 

support benefits. The fees to be 

collected resulting from this rule will 

be approximately $3 million in the first 

year, $1.9 million in the second year, 

and an average about $32 million in 

the third and subsequent years. To 

estimate the new fee collections to be 

generated by this rule, USCIS estimated 

the fees to be collected for new 

applications for adjustment of status 

from T and U nonimmigrants and their 

eligible family members. After that, 

USCIS estimated fees from associated 

applications that are required such as 

biometrics, and others that are likely 

to occur in direct connection with 

applications for adjustment, such as 

employment authorization or travel 

authorization. 

The anticipated benefits of these 

expenditures include: Continued 

assistance to trafficked victims and 

their families, increased investigation 

and prosecution of traffickers in 

persons, and the elimination of abuses 

caused by trafficking activities. 

Benefits that may be attributed to the 

implementation of this rule are 

expected to be: 

1. An increase in the number of cases 

brought forward for investigation 

and/or prosecution; 

2. Heightened awareness of traffickingin-persons issues by the law 

enforcement community; and 

3. Enhanced ability to develop and 

work cases in trafficking in persons 

cross-organizationally and multijurisdictionally, which may begin to 

influence changes in trafficking 

patterns. 

Risks: 

Congress created the U nonimmigrant 

status (‘‘U visa’’) to provide 

immigration protection to crime victims 

who assist in the investigation and 

prosecution of those crimes. Although 

there are no specific data on alien 

crime victims, statistics maintained by 

the Department of Justice have shown 

that aliens, especially those aliens 

without legal status, are often reluctant 

to help in the investigation or 

prosecution of crimes. U visas are 

intended to help overcome this 

reluctance and aid law enforcement 

accordingly. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 12/12/08 73 FR 75540 

Interim Final Rule 

Effective 

01/12/09 

Action Date FR Cite 

Interim Final Rule 

Comment Period 

End 

02/10/09 

Interim Final Rule 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal, Local, State 

Additional Information: 

CIS No. 2134-01 

Transferred from RIN 1115-AG21 

Agency Contact: 

Laura M. Dawkins 

Chief, Family Immigration and Victim 

Protection Division 

Department of Homeland Security 

U.S. Citizenship and Immigration 

Services 

20 Massachusetts Avenue NW. 

Suite 1200 

Washington, DC 20529 

Phone: 202 272–1470 

Fax: 202 272–1480 

Email: laura.dawkins@dhs.gov 

RIN: 1615–AA60 

DHS—USCIS 

68. NEW CLASSIFICATION FOR 

VICTIMS OF CRIMINAL ACTIVITY; 

ELIGIBILITY FOR THE ‘‘U’’ 

NONIMMIGRANT STATUS 

Priority: 

Other Significant 

Legal Authority: 

5 USC 552; 5 USC 552a; 8 USC 1101; 

8 USC 1101 note; 8 USC 1102 

CFR Citation: 

8 CFR 103; 8 CFR 204; 8 CFR 212; 8 

CFR 214; 8 CFR 299 

Legal Deadline: 

None 

Abstract: 

This rule sets forth application 

requirements for a new nonimmigrant 

status. The U classification is for nonU.S. Citizen/Lawful Permanent 

Resident victims of certain crimes who 

cooperate with an investigation or 

prosecution of those crimes. There is 

a limit of 10,000 principals per year. 

This rule establishes the procedures to 

be followed in order to petition for the 


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U nonimmigrant classifications. 

Specifically, the rule addresses the 

essential elements that must be 

demonstrated to receive the 

nonimmigrant classification, procedures 

that must be followed to make an 

application, and evidentiary guidance 

to assist in the petitioning process. 

Eligible victims will be allowed to 

remain in the United States. The 

Trafficking Victims Protection 

Reauthorization Act of 2008, Public 

Law 110-457, made amendments to the 

T nonimmigrant status provisions of 

the Immigration and Naturalization Act. 

The Department will issue another 

interim final rule to make the changes 

required by recent legislation and to 

provide the opportunity for notice and 

comment. 

Statement of Need: 

This rule provides requirements and 

procedures for aliens seeking U 

nonimmigrant status. U nonimmigrant 

classification is available to alien 

victims of certain criminal activity who 

assist government officials in the 

investigation or prosecution of that 

criminal activity. The purpose of the 

U nonimmigrant classification is to 

strengthen the ability of law 

enforcement agencies to investigate and 

prosecute such crimes as domestic 

violence, sexual assault, and trafficking 

in persons, while offering protection to 

alien crime victims in keeping with the 

humanitarian interests of the United 

States. 

Summary of Legal Basis: 

Congress created the U nonimmigrant 

classification in the Battered Immigrant 

Women Protection Act of 2000 

(BIWPA). Congress intended to 

strengthen the ability of law 

enforcement agencies to investigate and 

prosecute cases of domestic violence, 

sexual assault, trafficking of aliens, and 

other crimes, while offering protection 

to victims of such crimes. Congress also 

sought to encourage law enforcement 

officials to better serve immigrant crime 

victims. 

Alternatives: 

USCIS has identified four alternatives, 

the first being chosen for the rule: 

1. USCIS would adjudicate petitions on 

a first in, first out basis. Petitions 

received after the limit has been 

reached would be reviewed to 

determine whether or not they are 

approvable, but for the numerical cap. 

Approvable petitions that are reviewed 

after the numerical cap has been 

reached would be placed on a waiting 

list and written notice sent to the 

petitioner. Priority on the waiting list 

would be based upon the date on 

which the petition is filed. USCIS 

would provide petitioners on the 

waiting list with interim relief until the 

start of the next fiscal year in the form 

of deferred action, parole, or a stay of 

removal. 

2. USCIS would adjudicate petitions on 

a first in, first out basis, establishing 

a waiting list for petitions that are 

pending or received after the numerical 

cap has been reached. Priority on the 

waiting list would be based upon the 

date on which the petition was filed. 

USCIS would not provide interim relief 

to petitioners whose petitions are 

placed on the waiting list. 

3. USCIS would adjudicate petitions on 

a first in, first out basis. However, new 

filings would be reviewed to identify 

particularly compelling cases for 

adjudication. New filings would be 

rejected once the numerical cap is 

reached. No official waiting list would 

be established; however, interim relief 

until the start of the next fiscal year 

would be provided for some compelling 

cases. If a case was not particularly 

compelling, the filing would be denied 

or rejected. 

4. USCIS would adjudicate petitions on 

a first in, first out basis. However, new 

filings would be rejected once the 

numerical cap is reached. No waiting 

list would be established, nor would 

interim relief be granted. 

Anticipated Cost and Benefits: 

USCIS estimates the total annual cost 

of this interim rule to applicants to be 

$6.2 million. This cost includes the 

biometric services fee that petitioners 

must pay to USCIS, the opportunity 

cost of time needed to submit the 

required forms, the opportunity cost of 

time required for a visit to an 

Application Support Center, and the 

cost of traveling to an Application 

Support Center. 

This rule will strengthen the ability of 

law enforcement agencies to investigate 

and prosecute such crimes as domestic 

violence, sexual assault, and trafficking 

in persons, while offering protection to 

alien crime victims in keeping with the 

humanitarian interests of the United 

States. 

Risks: 

In the case of witness tampering, 

obstruction of justice, or perjury, the 

interpretive challenge for USCIS was to 

determine whom the BIWPA was meant 

to protect, given that these criminal 

activities are not targeted against a 

person. Accordingly it was determined 

that a victim of witness tampering, 

obstruction of justice, or perjury is an 

alien who has been directly and 

proximately harmed by the perpetrator 

of one of these three crimes, where 

there are reasonable grounds to 

conclude that the perpetrator 

principally committed the offense as a 

means: (1) to avoid or frustrate efforts 

to investigate, arrest, prosecute, or 

otherwise bring him or her to justice 

for other criminal activity; or (2) to 

further his or her abuse or exploitation 

of, or undue control over, the alien 

through manipulation of the legal 

system. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 09/17/07 72 FR 53013 

Interim Final Rule 

Effective 

10/17/07 

Interim Final Rule 

Comment Period 

End 

11/17/07 

Interim Final Rule 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal, Local, State 

Additional Information: 

Transferred from RIN 1115-AG39 

Agency Contact: 

Laura M. Dawkins 

Chief, Family Immigration and Victim 

Protection Division 

Department of Homeland Security 

U.S. Citizenship and Immigration 

Services 

20 Massachusetts Avenue NW. 

Suite 1200 

Washington, DC 20529 

Phone: 202 272–1470 

Fax: 202 272–1480 

Email: laura.dawkins@dhs.gov 

RIN: 1615–AA67 

DHS—USCIS 

69. E–2 NONIMMIGRANT STATUS FOR 

ALIENS IN THE COMMONWEALTH OF 

THE NORTHERN MARIANA ISLANDS 

WITH LONG–TERM INVESTOR 

STATUS 

Priority: 

Other Significant 

Legal Authority: 

8 USC 1101 to 1103; 8 USC 1182; 8 

USC 1184; 8 USC 1186a 


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CFR Citation: 

8 CFR 214 

Legal Deadline: 

None 

Abstract: 

This final rule amends Department of 

Homeland Security regulations 

governing E-2 nonimmigrant treaty 

investors to establish procedures for 

classifying long-term investors in the 

Commonwealth of the Northern 

Mariana Islands (CNMI) as E-2 

nonimmigrants. This final rule 

implements the CNMI nonimmigrant 

investor visa provisions of the 

Consolidated Natural Resources Act of 

2008, extending the immigration laws 

of the United States to the CNMI. 

Statement of Need: 

This final rule responds to a 

congressional mandate that requires the 

Federal Government to assume 

responsibility for visas for entry to 

CNMI by foreign investors. 

Anticipated Cost and Benefits: 

Public Costs: This rule reduces the 

employer’s annual cost by $200 per 

year ($500-$300), plus any further 

reduction caused by eliminating the 

paperwork burden associated with the 

CNMI’s process. In 2006 to 2007, there 

were 464 long-term business entry 

permit holders and 20 perpetual foreign 

investor entry permit holders and 

retiree investor permit holders, totaling 

484, or approximately 500 foreign 

registered investors. The total savings 

to employers from this rule is thus 

expected to be $100,000 per year ($500 

x $200). Cost to the Federal 

Government: The yearly Federal 

Government cost is estimated at 

$42,310. 

Benefits: The potential abuse of the visa 

system by those seeking to illegally 

emigrate from the CNMI to Guam or 

elsewhere in the United States reduces 

the integrity of the United States 

immigration system by increasing the 

ease by which aliens may unlawfully 

enter the United States through the 

CNMI. Federal oversight and 

regulations of CNMI foreign investors 

should help reduce abuse by foreign 

employees in the CNMI, and should 

help reduce the opportunity for aliens 

to use the CNMI as an entry point into 

the United States. 

Timetable: 

Action Date FR Cite 

NPRM 09/14/09 74 FR 46938 

Action Date FR Cite 

NPRM Comment 

Period End 

10/14/09 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Local, State 

Additional Information: 

CIS No. 2458-08 

Agency Contact: 

Kevin J. Cummings 

Chief of Business and Foreign Workers 

Division 

Department of Homeland Security 

U.S. Citizenship and Immigration 

Services 

Office of Policy and Strategy 

20 Massachusetts Avenue NW. 

Washington, DC 20529–2140 

Phone: 202 272–8410 

Fax: 202 272–1542 

Email: kevin.cummings@dhs.gov 

RIN: 1615–AB75 

DHS—USCIS 

70. COMMONWEALTH OF THE 

NORTHERN MARIANA ISLANDS 

TRANSITIONAL WORKER 

CLASSIFICATION 

Priority: 

Other Significant 

Legal Authority: 

PL 110–229 

CFR Citation: 

8 CFR 214.2 

Legal Deadline: 

None 

Abstract: 

The Department of Homeland Security 

(DHS) is creating a new, temporary, 

Commonwealth of the Northern 

Mariana Islands (CNMI)-only 

transitional worker classification (CW 

classification) in accordance with title 

VII of the Consolidated Natural 

Resources Act of 2008 (CNRA). The 

transitional worker program is intended 

to provide for an orderly transition 

from the CNMI permit system to the 

U.S. Federal immigration system under 

the Immigration and Nationality Act 

(INA). A CW transitional worker is an 

alien worker who is ineligible for 

another classification under the INA 

and who performs services or labor for 

an employer in the CNMI. The CNRA 

imposes a 5-year transition period 

before the INA requirements become 

fully applicable in the CNMI. The new 

CW classification will be in effect for 

the duration of that transition period, 

unless extended by the Secretary of 

Labor. The rule also establishes 

employment authorization incident to 

CW status. 

Statement of Need: 

Title VII of the Consolidated Natural 

Resources Act of 2008 (CNRA) created 

a new, temporary, Commonwealth of 

the Northern Mariana Islands (CNMI)- 

only transitional worker classification. 

The transitional worker program is 

intended to provide for an orderly 

transition from the CNMI permit system 

to the U.S. Federal immigration system 

under the Immigration and Nationality 

Act. 

Anticipated Cost and Benefits: 

Each of the estimated 22,000 CNMI 

transitional workers will be required to 

pay a $320 fee per year, for an 

annualized cost to the affected public 

of $7 million. However, since these 

workers will not have to pay CNMI 

fees, the total present value costs of this 

rule are a net cost savings ranging from 

$9.8 million to $13.4 million depending 

on the validity period of CW status (1 

or 2 years), whether out-of-status aliens 

present in the CNMI are eligible for CW 

status, and the discount rate applied. 

The intended benefits of the rule 

include improvements in national and 

homeland security and protection of 

human rights. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 10/27/09 74 FR 55094 

Interim Final Rule 

Comment Period 

End 

11/27/09 

Interim Final Rule 

Comment Period 

End Extended 

12/09/09 74 FR 64997 

Interim Final Rule 

Comment Period 

End 

01/08/10 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

State 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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Agency Contact: 

Kevin J. Cummings 

Chief of Business and Foreign Workers 

Division 

Department of Homeland Security 

U.S. Citizenship and Immigration 

Services 

Office of Policy and Strategy 

20 Massachusetts Avenue NW. 

Washington, DC 20529–2140 

Phone: 202 272–8410 

Fax: 202 272–1542 

Email: kevin.cummings@dhs.gov 

RIN: 1615–AB76 

DHS—USCIS 

71. APPLICATION OF IMMIGRATION 

REGULATIONS TO THE 

COMMONWEALTH OF THE 

NORTHERN MARIANA ISLANDS 

Priority: 

Other Significant 

Legal Authority: 

PL 110–229 

CFR Citation: 

8 CFR 208 and 209; 8 CFR 214 and 

215; 8 CFR 217; 8 CFR 235; 8 CFR 248; 

8 CFR 264; 8 CFR 274a 

Legal Deadline: 

Final, Statutory, November 28, 2009, 

Consolidated Natural Resources Act 

(CNRA) of 2008. 

Abstract: 

On October 28, 2009, the Department 

of Homeland Security (DHS) and the 

Department of Justice (DOJ) published 

a joint interim final rule in the Federal 

Register implementing conforming 

amendments to their respective 

regulations to comply with the 

Consolidated Natural Resources Act of 

2008 (CNRA). The CNRA extends the 

immigration laws of the United States 

to the Commonwealth of the Northern 

Mariana Islands (CNMI). This rule 

finalizes the interim rule with 

additional changes to provisions 

concerning adjustment of status and 

change of status of aliens in the CNMI, 

immigrant petitions for multinational 

executives, acceptable documents for 

employment eligibility verification 

(Form I-9), and the Northern Marianas 

identification card. It is intended that 

such changes will ameliorate any 

adverse impact that implementation of 

the CNRA may have on CNMI 

employers and alien workers. 

Statement of Need: 

The Department of Homeland Security 

(DHS) and the Department of Justice 

(DOJ) are implementing conforming 

amendments to their respective 

regulations to comply with the 

Consolidated Natural Resources Act of 

2008 (CNRA). The CNRA extends the 

immigration laws of the United States 

to the Commonwealth of the Northern 

Mariana Islands (CNMI). This rule 

amends the regulations governing: 

Asylum and credible fear of 

persecution determinations; references 

to the geographical ‘‘United States’’ and 

its territories and possessions; alien 

classifications authorized for 

employment; documentation acceptable 

for Employment Eligibility Verification; 

employment of unauthorized aliens; 

and adjustment of status of immediate 

relatives admitted under the GuamCNMI Visa Waiver Program. 

Additionally, this rule makes a 

technical change to correct a citation 

error in the regulations governing the 

Visa Waiver Program and the 

regulations governing asylum and 

withholding of removal. 

Anticipated Cost and Benefits: 

The stated goals of the CNRA are to 

ensure effective border control 

procedures, to properly address 

national security and homeland 

security concerns by extending U.S. 

immigration law to the CNMI, and to 

maximize the CNMI’s potential for 

future economic and business growth. 

While those goals are expected to be 

partly facilitated by the changes made 

in this rule, they are general and 

qualitative in nature. There are no 

specific changes made by this rule with 

sufficiently identifiable direct or 

indirect economic impacts so as to be 

quantified. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 10/28/09 74 FR 55725 

Interim Final Rule 

Comment Period 

End 

11/27/09 

Correction 12/22/09 74 FR 67969 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Additional Information: 

CIS 2460-08 

Agency Contact: 

Kevin Cummings 

Branch Chief, Business and Trade 

Services 

Department of Homeland Security 

U.S. Citizenship and Immigration 

Services 

Second Floor 

Office of Program and Regulations 

Development 

20 Massachusetts Avenue NW. 

Washington, DC 20529 

Phone: 202 272–8412 

Fax: 202 272–1452 

Email: kevin.cummings@dhs.gov 

RIN: 1615–AB77 

DHS—U.S. Coast Guard (USCG) 

PROPOSED RULE STAGE 

72. OUTER CONTINENTAL SHELF 

ACTIVITIES 

Priority: 

Other Significant 

Legal Authority: 

43 USC 1333(d)(1); 43 USC 1348(c); 43 

USC 1356; DHS Delegation No 0170.1 

CFR Citation: 

33 CFR 140 to 147 

Legal Deadline: 

None 

Abstract: 

The Coast Guard is the lead Federal 

agency for workplace safety and health, 

other than for matters generally related 

to drilling and production that are 

regulated by the Bureau of Ocean 

Energy Management, Regulation and 

Enforcement (BOEMRE) on facilities 

and vessels engaged in the exploration 

for, or development or production of, 

minerals on the OCS. This project 

would revise the regulations on Outer 

Continental Shelf (OCS) activities to: 1) 

Add new requirements for fixed OCS 

facilities for lifesaving, fire protection, 

training, hazardous materials used as 

stores and accommodation spaces; and 

2) address foreign vessels engaged in 

OCS activities to comply with 

requirements similar to those imposed 

on U.S. vessels similarly engaged. This 

project would affect the owners and 

operators of facilities and vessels 

engaged in offshore activities. 

Statement of Need: 

The last major revision of Coast Guard 

OCS regulations occurred in 1982. At 


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that time, the offshore industry was not 

as technologically advanced as it is 

today. Offshore activities were in 

relatively shallow water near land, 

where help was readily available 

during emergency situations. The 

equipment regulations required only 

basic equipment, primarily for 

lifesaving appliances and hand-held 

portable fire extinguishers. Since 1982, 

the requirements in 33 CFR chapter I, 

subchapter N, have not kept pace with 

the changing offshore technology or the 

safety problems created as OCS 

activities extend to deeper water 

(10,000 feet) and move farther offshore 

(150 miles). This rulemaking reassesses 

all of our current OCS regulations in 

order to help make the OCS a safer 

workplace. 

Summary of Legal Basis: 

The authority for the Coast Guard to 

prescribe, change, revise, or amend 

these regulations is provided under 14 

U.S.C. 85; 43 U.S.C. 1333(d)(1), 1347(c), 

1348(c), 1356; and Department of 

Homeland Security Delegation No. 

0170.1. Section 145.100 also issued 

under 14 U.S.C. 664 and 31 U.S.C. 

9701. 

Alternatives: 

The Coast Guard considered filling the 

shortfall in existing OCS regulations by 

extending the current vessel and 

Mobile Offshore Drilling Unit 

regulations. This approach was rejected 

after concluding that the differences 

between fixed and floating units made 

this approach impractical. We also 

considered requiring compliance with 

industry standards. Those standards, 

though, do not cover all of the areas 

needing regulation. The new rule 

would adopt available consensus 

standards where appropriate. 

Nonregulatory alternatives, such as 

agency policy documents and voluntary 

acceptance of industry standards were 

also considered. They were also 

rejected because enforceable regulations 

are necessary in order to carry out the 

relevant statutes. 

Anticipated Cost and Benefits: 

The Coast Guard is currently estimating 

the costs and benefits associated with 

this rulemaking. Industry would incur 

additional costs as a result of 

provisions for training, firefighting, 

lifesaving, and monitoring of unsafe 

conditions. This proposed rule supports 

the Commandant’s strategic goals of 

marine safety and environmental 

stewardship and is designed to help 

make the OCS a safer workplace by 

preventing accidents or reducing the 

consequences of accidents on the OCS. 

In addition, the proposed rule will 

include measures that meet the 

changing offshore technology and the 

safety problems it creates as OCS 

activities extend to deeper water and 

move farther offshore. 

Risks: 

The extensive revisions to health and 

safety requirements for OCS units in 

this rule would substantially reduce the 

risk of injury or illness on those units. 

Timetable: 

Action Date FR Cite 

Request for 

Comments 

06/27/95 60 FR 33185 

Comment Period End 09/25/95 

NPRM 12/07/99 64 FR 68416 

NPRM Correction 02/22/00 65 FR 8671 

NPRM Comment 

Period Extended 

03/16/00 65 FR 14226 

NPRM Comment 

Period Extended 

06/30/00 65 FR 40559 

NPRM Comment 

Period End 

11/30/00 

Supplemental NPRM 08/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

None 

Additional Information: 

Docket Numbers: The notice of request 

for comments published June 27, 1995, 

was assigned Coast Guard docket 

number 95-016. Following the request 

for comments, that docket was 

terminated. This project continues 

under Docket No. USCG-1998-3868 and 

RIN 1625-AA18. This docket may be 

viewed online by going to 

www.regulations.gov. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Kevin Y. Pekarek 

Program Manager 

Department of Homeland Security 

U.S. Coast Guard 

Commandant, CG–5222 

2100 2nd Street SW., STOP 7126 

Washington, DC 20593–7126 

Phone: 202 372–1386 

Email: kevin.y.pekarek2@uscg.mil 

RIN: 1625–AA18 

DHS—USCG 

73. INSPECTION OF TOWING 

VESSELS 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Legal Authority: 

46 USC 3103; 46 USC 3301; 46 USC 

3306; 46 USC 3308; 46 USC 3316; 46 

USC 3703; 46 USC 8104; 46 USC 8904; 

DHS Delegation No 0170.1 

CFR Citation: 

46 CFR 2; 46 CFR 15; 46 CFR 136 to 

144 

Legal Deadline: 

NPRM, Statutory, January 13, 2011. 

On October 15, 2010, the Coast Guard 

Authorization Act of 2010 was enacted 

as Public Law 111-281. It requires that 

a proposed rule be issued within 90 

days after enactment and that a final 

rule be issued within 1 year of 

enactment. 

Abstract: 

This rulemaking would implement a 

program of inspection for certification 

of towing vessels, which were 

previously uninspected. It would 

prescribe standards for safety 

management systems and third-party 

auditors and surveyors, along with 

standards for construction, operation, 

vessel systems, safety equipment, and 

recordkeeping. 

Statement of Need: 

This rulemaking would implement 

sections 409 and 415 of the Coast 

Guard and Maritime Transportation Act 

of 2004. The intent of the proposed rule 

is to promote safer work practices and 

reduce casualties on towing vessels by 

ensuring that towing vessels adhere to 

prescribed safety standards and safety 

management systems. This proposed 

rule was developed in cooperation with 

the Towing Vessel Safety Advisory 

Committee. It would establish a new 

subchapter dedicated to towing vessels; 

covering vessel equipment, systems, 

operational standards, and inspection 

requirements. 

Summary of Legal Basis: 

Proposed new subchapter authority: 46 

U.S.C. 3103, 3301, 3306, 3308, 3316, 

8104, 8904; 33 CFR 1.05; DHS 

Delegation 0170.1. 

The Coast Guard and Maritime 

Transportation Act of 2004 (CGMTA 

2004), Public Law 108-293, 118 Stat. 

1028, (Aug. 9, 2004), established new 


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authorities for towing vessels as 

follows: 

Section 415 added towing vessels, as 

defined in section 2101 of title 46, 

United States Code (U.S.C.), as a class 

of vessels that are subject to safety 

inspections under chapter 33 of that 

title (Id. at 1047). 

Section 415 also added new section 

3306(j) of title 46, authorizing the 

Secretary of Homeland Security to 

establish, by regulation, a safety 

management system appropriate for the 

characteristics, methods of operation, 

and nature of service of towing vessels 

(Id.). 

Section 409 added new section 8904(c) 

of title 46, U.S.C., authorizing the 

Secretary to establish, by regulation, 

‘‘maximum hours of service (including 

recording and recordkeeping of that 

service) of individuals engaged on a 

towing vessel that is at least 26 feet 

in length measured from end to end 

over the deck (excluding the sheer).‘‘ 

(Id. at 1044-45). 

Alternatives: 

We considered the following 

alternatives for the notice of proposed 

rulemaking (NPRM): 

One regulatory alternative would be the 

addition of towing vessels to one or 

more existing subchapters that deal 

with other inspected vessels, such as 

cargo and miscellaneous vessels 

(subchapter I), offshore supply vessels 

(subchapter L), or small passenger 

vessels (subchapter T). We do not 

believe, however, that this approach 

would recognize the often ‘‘unique’’ 

nature and characteristics of the towing 

industry in general and towing vessels 

in particular. 

In addition to inclusion in a particular 

existing subchapter (or subchapters) for 

equipment-related concerns, the same 

approach could be adopted for use of 

a safety management system by 

requiring compliance with title 33, 

Code of Federal Regulations, part 96 

(Rules for the Safe Operation of Vessels 

and Safety Management Systems). 

Adoption of these requirements, 

without an alternative safety 

management system, would also not be 

‘‘appropriate for the characteristics, 

methods of operation, and nature of 

service of towing vessels.‘‘ 

The Coast Guard has had extensive 

public involvement (four public 

meetings, over 100 separate comments 

submitted to the docket, as well as 

extensive ongoing dialogue with 

members of the Towing Safety 

Advisory Committee (TSAC)) regarding 

development of these regulations. 

Adoption of one of the alternatives 

discussed above would likely receive 

little public or industry support, 

especially considering the TSAC efforts 

toward development of standards to be 

incorporated into a separate subchapter 

dealing specifically with the inspection 

of towing vessels. 

An approach that would seem to be 

more in keeping with the intent of 

Congress would be the adoption of 

certain existing standards from those 

applied to other inspected vessels. In 

some cases, these existing standards 

would be appropriately modified and 

tailored to the nature and operation of 

certain categories of towing vessels. 

The adopted standards would come 

from inspected vessels that have 

demonstrated ‘‘good marine practice’’ 

within the maritime community. These 

regulations would be incorporated into 

a subchapter specifically addressing the 

inspection for certification of towing 

vessels. The law requiring the 

inspection for certification of towing 

vessels is a statutory mandate, 

compelling the Coast Guard to develop 

regulations appropriate for the nature 

of towing vessels and their specific 

industry. 

Anticipated Cost and Benefits: 

We estimate that owners and operators 

of towing vessels would incur 

additional costs from this rulemaking. 

The cost of this rulemaking would 

involve provisions for safety 

management systems, standards for 

construction, operation, vessel systems, 

safety equipment, and recordkeeping. 

Our cost assessment includes existing 

and new vessels. We are currently 

developing cost estimates for the 

proposed rule. 

The Coast Guard developed the 

requirements in the proposed rule by 

researching both the human factors and 

equipment failures that caused towing 

vessel accidents. We believe that the 

proposed rule would address a wide 

range of causes of towing vessel 

accidents and supports the main goal 

of improving safety in the towing 

industry. The primary benefit of the 

proposed rule is an increase in vessel 

safety and a resulting decrease in the 

risk of towing vessel accidents and 

their consequences. 

Risks: 

This regulatory action would reduce 

the risk of towing vessel accidents and 

their consequences. Towing vessel 

accidents result in fatalities, injuries, 

property damage, pollution, and delays. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions, 

Organizations 

Government Levels Affected: 

State 

Additional Information: 

The Regulations.gov docket number is 

USCG-2006-24412. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Michael Harmon 

Program Manager, CG–5222 

Department of Homeland Security 

U.S. Coast Guard 

2100 2nd Street SW., STOP 7126 

Washington, DC 20593–7126 

Phone: 202 372–1427 

Email: michael.j.harmon@uscg.mil 

RIN: 1625–AB06 

DHS—USCG 

74. ASSESSMENT FRAMEWORK AND 

ORGANIZATIONAL RESTATEMENT 

REGARDING PREEMPTION FOR 

CERTAIN REGULATIONS ISSUED BY 

THE COAST GUARD 

Priority: 

Other Significant 

Legal Authority: 

14 USC 2; 14 USC 91; 33 USC 1223; 

33 USC 1231; 33 USC 1903(b); 46 USC 

3203; 46 USC 3306; 46 USC 3703; 46 

USC 3717; 46 USC 4302; 46 USC 6101; 

DHS Delegation No 0170.1 

CFR Citation: 

33 CFR 1.06 

Legal Deadline: 

None 

Abstract: 

The proposed rule will operate in two 

ways. First, it will describe the Coast 

Guard’s interpretation of the 

preemptive effect of certain current 

Coast Guard regulations. This analysis 

will apply to previously promulgated 


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regulations even if a complete 

description of federalism implications 

was clearly articulated in the 

development of the regulation. Second, 

the rule will set forth criteria and a 

process that the Coast Guard will 

undertake in future regulatory projects 

for evaluating the preemptive impact of 

those regulations. This part of the 

analysis is prospective in nature and 

will lay out a roadmap for future 

regulatory projects regarding federalism 

and preemption principles. This 

rulemaking will support the Coast 

Guard’s broad role and responsibility of 

further enhancing maritime 

stewardship by reinforcing a uniform 

maritime regulatory regime that is 

predictable and useful for maritime 

interests. 

Statement of Need: 

In light of recent Federal court cases 

and the President’s May 20, 2009, 

memorandum regarding preemption, 

the Coast Guard believes that a clear 

agency statement of the preemptive 

impact of our regulations, particularly 

those regulations issued prior to the 

promulgation of E.O. 13132, can be of 

great benefit to State and local 

governments, the public, and regulated 

entities. Therefore, the Coast Guard 

intends to issue a general statement of 

preemption policy, coupled with 

specific statements of policy regarding 

regulations issued under the authority 

of statutes with preemptive effect, 

including, among others, the Ports and 

Waterways Safety Act (PWSA) of 1972, 

as amended (33 U.S.C. 1221 et. seq.). 

The Coast Guard proposes to publish 

these policies in a new section 1.06 of 

title 33 of the Code of Federal 

Regulations, to allow for easy access by 

interested persons and parties. 

Summary of Legal Basis: 

The statutory authorities for the Coast 

Guard to prescribe, change, revise, or 

amend these regulations are provided 

under 14 U.S.C. 2 and 91; 33 U.S.C. 

1223, 1231, and 1903(b); 46 U.S.C. 

3203, 3306, 3703, 3717, 4302, and 

6101; and Department of Homeland 

Security Delegation No. 0170.1. 

Alternatives: 

The Coast Guard considered alternative 

mechanisms for restating the 

preemptive effect of regulations, 

including the use of a notice of policy. 

These methods would not provide the 

same level of transparency as 

codification in the Code of Federal 

Regulations, however, because they 

would not be as readily located by 

State and local government or other 

members of the public. They also 

would not satisfy the President’s May 

20, 2009, memorandum regarding 

preemption, which directs agencies to 

include preemption provisions in the 

codified regulation. 

Anticipated Cost and Benefits: 

We expect no additional cost impacts 

to the industry from this proposed rule, 

because it only restates and clarifies the 

status of Federal and State law as it 

exists. 

Risks: 

Not applicable to this rulemaking. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Additional Information: 

The docket number for this rulemaking 

is USCG-2008-1259. The docket can be 

found at www.regulations.gov. 

URL For More Information: 

http://www.regulations.gov 

URL For Public Comments: 

http://www.regulations.gov 

Agency Contact: 

LCDR Stephen DaPonte 

Program Manager 

Department of Homeland Security 

U.S. Coast Guard 

Commandant (CG–0941) 

2100 2nd Street SW., STOP 7121 

Washington, DC 20593–7121 

Phone: 202 372–3865 

Email: stephen.daponte@uscg.mil 

RIN: 1625–AB32 

DHS—USCG 

75. UPDATES TO MARITIME 

SECURITY 

Priority: 

Economically Significant. Major status 

under 5 USC 801 is undetermined. 

Legal Authority: 

33 USC 1226; 33 USC 1231; 46 USC 

ch 701; 50 USC 191 and 192; EO 12656; 

3 CFR 1988 Comp, p 585; 33 CFR 

1.05–1; 33 CFR 6.04–11; 33 CFR 6.14; 

33 CFR 6.16; 33 CFR 6.19; DHS 

Delegation No 0170.1 

CFR Citation: 

33 CFR subchapter H 

Legal Deadline: 

None 

Abstract: 

The Coast Guard proposes certain 

additions, changes, and amendments to 

33 CFR, subchapter H. Subchapter H 

is comprised of parts 101 thru 106. 

Subchapter H implements the major 

provisions of the Maritime 

Transportation Security Act of 2002. 

This rulemaking is the first major 

revision to subchapter H. The proposed 

changes would further enhance the 

security of our Nation’s ports, vessels, 

facilities, and Outer Continental Shelf 

facilities and incorporate requirements 

from legislation implemented since the 

original publication of these regulations 

in 2003. This rulemaking has 

international interest because of the 

close relationship between subchapter 

H and the International Ship and Port 

Security Code (ISPS). 

Statement of Need: 

This rulemaking is needed to 

incorporate Coast Guard Policy 

Advisory Council (PAC) decisions on 

the interpretation of regulations, 

guidance provided in response to 

questions to the Maritime 

Transportation Security Act of 2002 

(MTSA) hotline, and to implement 

various requirements found in the 

Security and Accountability for Every 

Port Act of 2006 and the Coast Guard 

and Maritime Transportation Act of 

2006. In addition, this rulemaking is 

needed to incorporate 

recommendations from the Merchant 

Marine Personnel Advisory Committee. 

It also incorporates various U.S. 

Maritime Administration and 

International Maritime Organization 

voluntary consensus standards related 

to maritime security training. 

Summary of Legal Basis: 

The fundamental legal basis for 

subchapter H remains the Maritime 

Transportation Security Act of 2002 as 

amended by the Security and 

Accountability for Every Port Act of 

2006 and the Coast Guard and Maritime 

Transportation Act of 2006. 

Alternatives: 

The Coast Guard is currently evaluating 

a number of alternatives based on 

applicability and risk (threat, 


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vulnerability, and consequence). 

However, an overall update to make 

necessary changes to subchapter H and 

address improvements resulting from 

our experience since 2003 is prudent. 

Anticipated Cost and Benefits: 

The Coast Guard is currently estimating 

the costs associated with this 

rulemaking. Industry would incur 

additional costs as a result of 

provisions for standardized training 

requirements, updates to security plans 

and other documentation, and full-scale 

exercises requirements for high-risk 

facilities. The potential benefit from 

these provisions is reduction in risk of 

security incidents. This rulemaking 

expands and improves competencies 

associated with Maritime Domain 

Awareness (MDA). MDA is the effective 

understanding of anything associated 

with the global maritime domain that 

could impact the United States’ 

security, safety, economy, or 

environment. The proposed rule would 

improve MDA through training, 

exercise, and security plan 

enhancements. As a result, the primary 

benefit of the proposed rule would 

result from reducing the risk of a 

Transportation Security Incident (TSI) 

and therefore averting or mitigating the 

economic and environmental 

consequences of a TSI. 

Risks: 

With this rulemaking, the Coast Guard 

seeks to maintain the risk reduction 

goals established with the promulgation 

of the original MTSA regulations and 

further reduce risks by incorporating 

provisions related to more recent 

legislation and warranted by our 

experience with subchapter H since 

2003. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Additional Information: 

The Regulations.gov docket number for 

this rulemaking is USCG-2007-0009. 

URL For More Information: 

http://www.regulations.gov 

URL For Public Comments: 

http://www.regulations.gov 

Agency Contact: 

LCDR Loan O’Brien 

Project Manager 

Department of Homeland Security 

U.S. Coast Guard 

Commandant, (CG–5442) 

2100 2nd Street SW., STOP 7581 

Washington, DC 20593–7581 

Phone: 877 687–2243 

Fax: 202 372–1906 

Email: loan.t.o’brien@uscg.mil 

RIN: 1625–AB38 

DHS—USCG 

FINAL RULE STAGE 

76. STANDARDS FOR LIVING 

ORGANISMS IN SHIPS’ BALLAST 

WATER DISCHARGED IN U.S. 

WATERS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

16 USC 4711 

CFR Citation: 

33 CFR 151 

Legal Deadline: 

None 

Abstract: 

This rulemaking adds performance 

standards to 33 CFR part 151, subparts 

C and D, for discharges of ballast water. 

It supports the Coast Guard’s broad 

roles and responsibilities of maritime 

safety and maritime stewardship. This 

project is economically significant. 

Statement of Need: 

The unintentional introduction of 

nonindigenous species into U.S. waters 

via the discharge of vessels’ ballast 

water has had significant impacts to the 

Nation’s aquatic resources, biological 

diversity, and coastal infrastructures. 

This rulemaking would amend the 

ballast water management requirements 

(33 CFR part 151, subparts C and D) 

and establish standards that specify the 

level of biological treatment that must 

be achieved by a ballast water 

treatment system before ballast water 

can be discharged into U.S. waters. 

This would increase the Coast Guard’s 

ability to protect U.S. waters against the 

introduction of nonindigenous species 

via ballast water discharges. 

Summary of Legal Basis: 

Congress has directed the Coast Guard 

to develop ballast water regulations to 

prevent the introduction of 

nonindigenous species into U.S. waters 

under the Nonindigenous Aquatic 

Nuisance Prevention and Control Act 

of 1990 and reauthorized and amended 

it with the National Invasive Species 

Act of 1996. This rulemaking does not 

have a statutory deadline. 

Alternatives: 

The Coast Guard would use the 

standard rulemaking process to develop 

regulations for ballast water discharge 

standards. Nonregulatory alternatives 

such as navigation and vessel 

inspection circulars and the 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 

regulations. Nonregulatory alternatives 

cannot be substituted for the standards 

we would develop with this rule. 

Congress has directed the Coast Guard 

to review and revise its BWM 

regulations not less than every 3 years 

based on the best scientific information 

available to the Coast Guard at the time 

of that review. 

On August 28, 2009, the Coast Guard 

published the Notice of Proposed 

Rulemaking (NPRM) entitled Standards 

for Living Organisms in Ships’ Ballast 

Water Discharged in U.S. Waters in the 

Federal Register (74 FR 44632). The 

proposed rule included a phase-in 

schedule (phase-one and phase-two) for 

the implementation of ballast water 

discharge standards based on vessel’s 

ballast water capacity and build date 

(one that is one thousand times more 

stringent). The proposed phase-one 

standard is the same standard adopted 

by the International Maritime 

Organization (IMO) for concentration of 

living organisms in ballast water 

discharges. For phase-two, we propose 

incorporating a practicability review to 

determine whether technology to 

achieve a more stringent standard than 


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the IMO standard can practicably be 

implemented. 

Based on the comments received, we 

plan to move forward swiftly with a 

final rule. 

Anticipated Cost and Benefits: 

This rulemaking would affect certain 

vessels operating in U.S. waters seeking 

to discharge ballast water into waters 

of the United States. Owners and 

operators of these vessels would be 

required to install and operate Coast 

Guard approved ballast water 

management systems before discharging 

ballast water into U.S. waters. Cost 

estimates for individual vessels vary 

due to the vessel class, type and size, 

and the particular technology of the 

ballast water management system 

installed. We expect the highest annual 

costs of this rulemaking during the 

periods of installation as the bulk of 

the existing fleet of vessels must meet 

the standards according to proposed 

phase-in schedules. The primary cost 

driver of this rulemaking is the 

installation costs for existing vessels. 

Operating and maintenance costs are 

substantially less than the installation 

costs. 

We evaluated the benefits of this 

rulemaking by researching the impact 

of aquatic nonindigenous species (NIS) 

invasions in the U.S. waters, since 

ballast water discharge is one of the 

main vectors of NIS introductions in 

the marine environment. The primary 

benefit of this rulemaking would be the 

economic and environmental damages 

avoided from the reduction in the 

number of new invasions as a result 

of the reduction in concentration of 

organisms in discharged ballast water. 

We expect that the benefits of this 

rulemaking would increase as the 

technology is developed to achieve 

more stringent ballast water discharge 

standards. 

The Coast Guard issued a preliminary 

regulatory analysis of the costs, 

benefits, and other impacts of the 2009 

NPRM. In this preliminary analysis, we 

estimated the total phase-one costs to 

be about $1.18 billion over a 10-year 

period of analysis (this and other 

values below at a 7 percent discount 

rate). As previously described, the 

implementation costs vary by year. We 

estimated the annualized cost over the 

same period to be approximately $168 

million per year. We did not provide 

cost estimates for the phase-two costs 

in this preliminary analysis since data 

and information was not available at 

that time for technology that would 

meet the anticipated phase-two 

standard (1,000 x the IMO standard). 

In the same preliminary analysis, we 

estimated annualized benefits (damages 

avoided) for phase one are potentially 

as high as $553 million, with a midrange estimate of $165 million to $282 

million per year. We estimated total 

phase-one benefits to be as high as 

$3.88 billion, with a mid-range estimate 

of $1.16 billion to $1.98 billion over 

a 10-year period of analysis. 

The Coast Guard has received public 

comments on the impacts of the NPRM 

and will be incorporating these 

comments into a revised Regulatory 

Analysis for the next rulemaking 

publication. 

Risks: 

Ballast water discharged from ships is 

a significant pathway for the 

introduction and spread of nonindigenous aquatic nuisance species. 

These organisms, which may be plants, 

animals, bacteria or pathogens, have the 

potential to displace native species, 

degrade native habitats, spread disease 

and disrupt human economic and 

social activities that depend on water 

resources. It is estimated that for areas 

such as the Great Lakes, San Francisco 

Bay, and Chesapeake Bay, one 

nonindigenous species becomes 

established per year. At this time, it 

is difficult to estimate the reduction of 

risk that would be accomplished by 

promulgating this rulemaking; however, 

it is expected a major reduction will 

occur. We are currently requesting 

information on costs and benefits of 

more stringent ballast water discharge 

standards. 

Timetable: 

Action Date FR Cite 

ANPRM 03/04/02 67 FR 9632 

ANPRM Comment 

Period End 

06/03/02 

NPRM 08/28/09 74 FR 44632 

Public Meeting 09/14/09 74 FR 46964 

Public Meeting 09/22/09 74 FR 48190 

Public Meeting 09/28/09 74 FR 49355 

Notice—Extension of 

Comment Period 

10/15/09 74 FR 52941 

Public Meeting 10/22/09 74 FR 54533 

Public Meeting 

Correction 

10/26/09 74 FR 54944 

NPRM Comment 

Period End 

12/04/09 74 FR 52941 

Final Rule 04/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

State 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Additional Information: 

The Regulations.gov docket number for 

this rulemaking is USCG-2001-10486. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Mr. John C Morris 

Project Manager 

Department of Homeland Security 

U.S. Coast Guard 

2100 Second Street SW., STOP 7126 

Washington, DC 20593–7126 

Phone: 202 372–1433 

Email: john.c.morris@uscg.mil 

RIN: 1625–AA32 

DHS—U.S. Customs and Border 

Protection (USCBP) 

FINAL RULE STAGE 

77. IMPORTER SECURITY FILING AND 

ADDITIONAL CARRIER 

REQUIREMENTS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

PL 109–347, sec 203; 5 USC 301; 19 

USC 66; 19 USC 1431; 19 USC 1433 

to 1434; 19 USC 1624; 19 USC 2071 

note; 46 USC 60105 

CFR Citation: 

19 CFR 4; 19 CFR 12.3; 19 CFR 18.5; 

19 CFR 103.31a; 19 CFR 113; 19 CFR 

123.92; 19 CFR 141.113; 19 CFR 146.32; 

19 CFR 149; 19 CFR 192.14 

Legal Deadline: 

None 

Abstract: 

This interim final rule implements the 

provisions of section 203 of the 


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Security and Accountability for Every 

Port Act of 2006. It amends CBP 

Regulations to require carriers and 

importers to provide to CBP, via a CBPapproved electronic data interchange 

system, information necessary to enable 

CBP to identify high-risk shipments to 

prevent smuggling and insure cargo 

safety and security. Under the rule, 

importers and carriers must submit 

specified information to CBP before the 

cargo is brought into the United States 

by vessel. This advance information 

will improve CBP’s risk assessment and 

targeting capabilities, assist CBP in 

increasing the security of the global 

trading system, and facilitate the 

prompt release of legitimate cargo 

following its arrival in the United 

States. 

Statement of Need: 

Vessel carriers are currently required to 

transmit certain manifest information 

by way of the CBP Vessel Automated 

Manifest System (AMS) 24 hours prior 

to lading of containerized and nonexempt break bulk cargo at a foreign 

port. For the most part, this is the 

ocean carrier’s or non-vessel operating 

common carrier (NVOCC)’s cargo 

declaration. CBP analyzes this 

information to generate its risk 

assessment for targeting purposes. 

Internal and external government 

reviews have concluded that more 

complete advance shipment data would 

produce even more effective and 

vigorous cargo risk assessments. In 

addition, pursuant to section 203 of the 

Security and Accountability for Every 

Port Act of 2006 (Pub. L. 109-347, 6 

U.S.C. 943) (SAFE Port Act), the 

Secretary of Homeland Security, acting 

through the Commissioner of CBP, 

must promulgate regulations to require 

the electronic transmission of 

additional data elements for improved 

high-risk targeting, including 

appropriate security elements of entry 

data for cargo destined to the United 

States by vessel prior to loading of such 

cargo on vessels at foreign seaports. 

Based upon its analysis, as well as the 

requirements under the SAFE Port Act, 

CBP is requiring the electronic 

transmission of additional data for 

improved high-risk targeting. Some of 

these data elements are being required 

from carriers (Container Status 

Messages and Vessel Stow Plan) and 

others are being required from 

‘‘importers,’’ as that term is defined for 

purposes of the regulations. 

This rule intends to improve CBP’s risk 

assessment and targeting capabilities 

and enables the agency to facilitate the 

prompt release of legitimate cargo 

following its arrival in the United 

States. The information will assist CBP 

in increasing the security of the global 

trading system and, thereby, reducing 

the threat to the United States and 

world economy. 

Summary of Legal Basis: 

Pursuant to section 203 of the Security 

and Accountability for Every Port Act 

of 2006 (Pub. L. 109-347, 6 U.S.C. 943) 

(SAFE Port Act), the Secretary of 

Homeland Security, acting through the 

Commissioner of CBP, must promulgate 

regulations to require the electronic 

transmission of additional data 

elements for improved high-risk 

targeting, including appropriate 

security elements of entry data for 

cargo destined to the United States by 

vessel prior to loading of such cargo 

on vessels at foreign seaports. 

Alternatives: 

CBP considered and evaluated the 

following four alternatives: 

Alternative 1 (the chosen alternative): 

Importer Security Filings and 

Additional Carrier Requirements are 

required. Bulk cargo is exempt from the 

Importer Security Filing requirements; 

Alternative 2: Importer Security Filings 

and Additional Carrier Requirements 

are required. Bulk cargo is not exempt 

from the Importer Security Filing 

requirements; 

Alternative 3: Only Importer Security 

Filings are required. Bulk cargo is 

exempt from the Importer Security 

Filing requirements; and 

Alternative 4: Only the Additional 

Carrier Requirements are required. 

Anticipated Cost and Benefits: 

When the NPRM was published, CBP 

estimated that approximately 11 

million import shipments conveyed by 

1,000 different carrier companies 

operating 37,000 unique voyages or 

vessel-trips to the United States will be 

subject to the rule. Annualized costs 

range from $890 million to $7.0 billion 

(7 percent discount rate over 10 years). 

The annualized cost range results from 

varying assumptions about the 

importers’ estimated security filing 

transaction costs or fees charged to the 

importers by the filing parties, the 

potential for supply chain delays, and 

the estimated costs to carriers for 

transmitting additional data to CBP. 

The regulation may increase the time 

shipments are in transit, particularly for 

shipments consolidated in containers. 

For such shipments, the supply chain 

is generally more complex and the 

importer has less control of the flow 

of goods and associated security filing 

information. Foreign cargo 

consolidators may be consolidating 

multiple shipments from one or more 

shippers in a container destined for one 

or more buyers or consignees. In order 

to ensure that the security filing data 

is provided by the shippers to the 

importers (or their designated agents) 

and is then transmitted to and accepted 

by CBP in advance of the 24-hour 

deadline, consolidators may advance 

their cut-off times for receipt of 

shipments and associated security filing 

data. 

These advanced cut-off times would 

help prevent a consolidator or carrier 

from having to unpack or unload a 

container in the event the security 

filing for one of the shipments 

contained in the container is 

inadequate or not accepted by CBP. For 

example, consolidators may require 

shippers to submit, transmit, or obtain 

CBP approval of their security filing 

data before their shipments are stuffed 

in the container, before the container 

is sealed, or before the container is 

delivered to the port for lading. In such 

cases, importers would likely have to 

increase the times they hold their goods 

as inventory, and thus incur additional 

inventory carrying costs to sufficiently 

meet these advanced cut-off times 

imposed by their foreign consolidators. 

The high end of the cost ranges 

presented assumes an initial supply 

chain delay of 2 days for the first year 

of implementation (2008) and a delay 

of 1 day for years 2 through 10 (2009 

to 2017). 

Ideally, the quantification and 

monetization of the benefits of this 

regulation would involve estimating the 

current level of risk of a successful 

terrorist attack, absent this regulation, 

and the incremental reduction in risk 

resulting from implementation of the 

regulation. CBP would then multiply 

the change by an estimate of the value 

individuals place on such a risk 

reduction to produce a monetary 

estimate of direct benefits. However, 

existing data limitations and a lack of 

complete understanding of the true 

risks posed by terrorists prevent us 

from establishing the incremental risk 

reduction attributable to this rule. As 

a result, CBP has undertaken a ‘‘breakeven’’ analysis to inform 

decisionmakers of the necessary 

incremental change in the probability 

of such an event occurring that would 

result in direct benefits equal to the 

costs of the proposed rule. CBP’s 


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analysis finds that the incremental 

costs of this regulation are relatively 

small compared to the median value of 

a shipment of goods, despite the rather 

large absolute estimate of present value 

cost. 

The benefit of this rule is the 

improvement of CBP’s risk assessment 

and targeting capabilities, while at the 

same time, enabling CBP to facilitate 

the prompt release of legitimate cargo 

following its arrival in the United 

States. The information will assist CBP 

in increasing the security of the global 

trading system, and thereby reducing 

the threat to the United States and the 

world economy. 

Timetable: 

Action Date FR Cite 

NPRM 01/02/08 73 FR 90 

NPRM Comment 

Period End 

03/03/08 

NPRM Comment 

Period Extended 

02/01/08 73 FR 6061 

NPRM Comment 

Period End 

03/18/08 

Interim Final Rule 11/25/08 73 FR 71730 

Interim Final Rule 

Effective 

01/26/09 

Interim Final Rule 

Comment Period 

End 

06/01/09 

Correction 07/14/09 74 FR 33920 

Correction 12/24/09 74 FR 68376 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Richard DiNucci 

Department of Homeland Security 

U.S. Customs and Border Protection 

Office of Field Operations 

1300 Pennsylvania Avenue NW. 

Washington, DC 20229 

Phone: 202 344–2513 

Email: richard.dinucci@dhs.gov 

RIN: 1651–AA70 

DHS—USCBP 

78. CHANGES TO THE VISA WAIVER 

PROGRAM TO IMPLEMENT THE 

ELECTRONIC SYSTEM FOR TRAVEL 

AUTHORIZATION (ESTA) PROGRAM 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

8 USC 1103; 8 USC 1187; 8 CFR 2 

CFR Citation: 

8 CFR 217.5 

Legal Deadline: 

None 

Abstract: 

This rule implements the Electronic 

System for Travel Authorization (ESTA) 

for aliens who travel to the United 

States under the Visa Waiver Program 

(VWP) at air or sea ports of entry. 

Under the rule, VWP travelers are 

required to provide certain biographical 

information to CBP electronically 

before departing for the United States. 

This allows CBP to determine before 

their departure whether these travelers 

are eligible to travel to the United 

States under the VWP and whether 

such travel poses a security risk. The 

rule is intended to fulfill the 

requirements of section 711 of the 

Implementing recommendations of the 

9/11 Commission Act of 2007 (9/11 

Act). In addition to fulfilling a statutory 

mandate, the rule serves the twin goals 

of promoting border security and 

legitimate travel to the United States. 

By modernizing the VWP, the ESTA is 

intended to increase national security 

and to provide for greater efficiencies 

in the screening of international 

travelers by allowing for vetting of 

subjects of potential interest well before 

boarding, thereby reducing traveler 

delays at the ports of entry. 

Statement of Need: 

Section 711 of the 9/11 Act requires 

the Secretary of Homeland Security, in 

consultation with the Secretary of State, 

to develop and implement a fully 

automated electronic travel 

authorization system that will collect 

biographical and other information in 

advance of travel to determine the 

eligibility of the alien to travel to the 

United States, and to determine 

whether such travel poses a law 

enforcement or security risk. ESTA is 

intended to fulfill these statutory 

requirements. 

Under this rule, VWP travelers provide 

certain information to CBP 

electronically before departing for the 

United States. VWP travelers who 

receive travel authorization under 

ESTA are not required to complete the 

paper Form I-94W when arriving on a 

carrier that is capable of receiving and 

validating messages pertaining to the 

traveler’s ESTA status as part of the 

traveler’s boarding status. By 

automating the I-94W process and 

establishing a system to provide VWP 

traveler data in advance of travel, CBP 

is able to determine the eligibility of 

citizens and eligible nationals from 

VWP countries to travel to the United 

States and to determine whether such 

travel poses a law enforcement or 

security risk, before such individuals 

begin travel to the United States. ESTA 

provides for greater efficiencies in the 

screening of international travelers by 

allowing CBP to identify subjects of 

potential interest before they depart for 

the United States, thereby increasing 

security and reducing traveler delays 

upon arrival at U.S. ports of entry. 

Summary of Legal Basis: 

The ESTA program is based on 

congressional authority provided under 

section 711 of the Implementing 

Recommendations of the 9/11 

Commission Act of 2007 and section 

217 of the Immigration and Nationality 

Act (INA). 

Alternatives: 

CBP considered three alternatives to 

this rule: 

1. The ESTA requirements in the rule, 

but with a $1.50 fee per each travel 

authorization (more costly) 

2. The ESTA requirements in the rule, 

but with only the name of the 

passenger and the admissibility 

questions on the I-94W form (less 

burdensome) 

3. The ESTA requirements in the rule, 

but only for the countries entering the 

VWP after 2009 (no new requirements 

for VWP, reduced burden for newly 

entering countries) 

CBP determined that the rule provides 

the greatest level of enhanced security 

and efficiency at an acceptable cost to 

traveling public and potentially affected 

air carriers. 

Anticipated Cost and Benefits: 

The purpose of ESTA is to allow DHS 

and CBP to establish the eligibility of 

certain foreign travelers to travel to the 

United States under the VWP, and 

whether the alien’s proposed travel to 

the United States poses a law 

enforcement or security risk. Upon 

review of such information, DHS will 


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determine whether the alien is eligible 

to travel to the United States under the 

VWP. 

Costs to Air & Sea Carriers 

CBP estimated that eight U.S.-based air 

carriers and eleven sea carriers will be 

affected by the rule. An additional 35 

foreign-based air carriers and five sea 

carriers will be affected. CBP concluded 

that costs to air and sea carriers to 

support the requirements of the ESTA 

program could cost $137 million to 

$1.1 billion over the next 10 years 

depending on the level of effort 

required to integrate their systems with 

ESTA, how many passengers they need 

to assist in applying for travel 

authorizations, and the discount rate 

applied to annual costs. 

Costs to Travelers 

ESTA will present new costs and 

burdens to travelers in VWP countries 

who were not previously required to 

submit any information to the U.S. 

Government in advance of travel to the 

United States. Travelers from Roadmap 

countries who become VWP countries 

will also incur costs and burdens, 

though these are much less than 

obtaining a nonimmigrant visa 

(category B1/B2), which is currently 

required for short-term pleasure or 

business to travel to the United States. 

CBP estimated that the total quantified 

costs to travelers will range from $1.1 

billion to $3.5 billion depending on the 

number of travelers, the value of time, 

and the discount rate. Annualized costs 

are estimated to range from $133 

million to $366 million. 

Benefits 

As set forth in section 711 of the 9/11 

Act, it was the intent of Congress to 

modernize and strengthen the security 

of the Visa Waiver Program under 

section 217 of the Immigration and 

Nationality Act (INA, 8 U.S.C. 1187) by 

simultaneously enhancing program 

security requirements and extending 

visa-free travel privileges to citizens 

and eligible nationals of eligible foreign 

countries that are partners in the war 

on terrorism. 

By requiring passenger data in advance 

of travel, CBP may be able to 

determine, before the alien departs for 

the United States, the eligibility of 

citizens and eligible nationals from 

VWP countries to travel to the United 

States under the VWP, and whether 

such travel poses a law enforcement or 

security risk. In addition to fulfilling 

a statutory mandate, the rule serves the 

twin goals of promoting border security 

and legitimate travel to the United 

States. By modernizing the VWP, ESTA 

is intended to both increase national 

security and provide for greater 

efficiencies in the screening of 

international travelers by allowing for 

the screening of subjects of potential 

interest well before boarding, thereby 

reducing traveler delays based on 

potentially lengthy processes at U.S. 

ports of entry. 

CBP concluded that the total benefits 

to travelers could total $1.1 billion to 

$3.3 billion over the period of analysis. 

Annualized benefits could range from 

$134 million to $345 million. 

In addition to these benefits to 

travelers, CBP and the carriers should 

also experience the benefit of not 

having to administer the I-94W except 

in limited situations. While CBP has 

not conducted an analysis of the 

potential savings, it should accrue 

benefits from not having to produce, 

ship, and store blank forms. CBP 

should also be able to accrue savings 

related to data entry and archiving. 

Carriers should realize some savings as 

well, though carriers will still have to 

administer the I-94 for those passengers 

not traveling under the VWP and the 

Customs Declaration forms for all 

passengers aboard the aircraft and 

vessel. 

Timetable: 

Action Date FR Cite 

Interim Final Action 06/09/08 73 FR 32440 

Interim Final Rule 

Effective 

08/08/08 

Interim Final Rule 

Comment Period 

End 

08/08/08 

Notice – Announcing 

Date Rule Becomes 

Mandatory 

11/13/08 73 FR 67354 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Additional Information: 

http://www.cbp.gov/xp/cgov/travel/ 

idlvisa/esta/ 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Suzanne Shepherd 

Director, Electronic System for Travel 

Authorization 

Department of Homeland Security 

U.S. Customs and Border Protection 

1300 Pennsylvania Avenue NW. 

Washington, DC 20229 

Phone: 202 344–2073 

Email: cbp.esta@dhs.gov 

Related RIN: Related to 1651–AA83 

RIN: 1651–AA72 

DHS—USCBP 

79. ESTABLISHMENT OF GLOBAL 

ENTRY PROGRAM 

Priority: 

Other Significant 

Legal Authority: 

8 USC 1365b(k)(1); 8 USC 1365b(k)(3); 

8 USC 1225; 8 USC 1185(b) 

CFR Citation: 

8 CFR 235; 8 CFR 103 

Legal Deadline: 

None 

Abstract: 

CBP already operates several regulatory 

and non-regulatory international 

registered traveler programs, also 

known as trusted traveler programs. In 

order to comply with the Intelligence 

Reform Terrorism Prevention Act of 

2004 (IRPTA), CBP is proposing to 

amend its regulations to establish 

another international registered traveler 

program called Global Entry. The 

Global Entry program would expedite 

the movement of low-risk, frequent 

international air travelers by providing 

an expedited inspection process for 

pre-approved, pre-screened travelers. 

These travelers would proceed directly 

to automated Global Entry kiosks upon 

their arrival in the United States. This 

Global Entry Program, along with the 

other programs that have already been 

established, are consistent with CBP’s 

strategic goal of facilitating legitimate 

trade and travel while securing the 

homeland. A pilot of Global Entry has 

been operating since June 6, 2008. 

Statement of Need: 

CBP has been operating the Global 

Entry program as a pilot at several 

airports since June 6, 2008, and the 

pilot has been very successful. As a 

result, there is a desire on the part of 


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the public that the program be 

established as a permanent program, 

and expanded, if possible. By 

establishing this program, CBP will 

make great strides toward facilitating 

the movement of people in a more 

efficient manner, thereby 

accomplishing our strategic goal of 

balancing legitimate travel with 

security. Through the use of biometric 

and recordkeeping technologies, the 

risk of terrorists entering the United 

States would be reduced. Improving 

security and facilitating travel at the 

border, both of which are accomplished 

by Global Entry, are primary concerns 

within CBP jurisdiction. 

Summary of Legal Basis: 

The Global Entry program is based on 

section 7208(k) of the Intelligence 

Reform and Terrorism Prevention Act 

of 2004 (IRTPA), as amended by section 

565 of the Consolidated Appropriations 

Act, which requires the Secretary of 

Homeland Security to create a program 

to expedite the screening and 

processing of pre-approved low risk air 

travelers into the United States. 

Anticipated Cost and Benefits: 

Global Entry is a voluntary program 

that provides a benefit to the public 

by speeding the CBP processing time 

for participating travelers. Travelers 

who are otherwise admissible to the 

United States will be able to enter or 

exit the country regardless of whether 

they participate in Global Entry. CBP 

estimates that over a 5-year period, 

250,000 enrollees will be processed (an 

annual average of 50,000 individuals). 

CBP will charge a fee of $100 per 

applicant and estimates that each 

application will require 40 minutes 

(0.67 hours) of the enrollee’s time to 

search existing data resources, gather 

the data needed, and complete and 

review the application form. 

Additionally, an enrollee will 

experience an ‘‘opportunity cost of 

time’’ to travel to an Enrollment Center 

upon acceptance of the initial 

application. We assume that 1 hour 

will be required for this time spent at 

the Enrollment Center and travel to and 

from the Center, though we note that 

during the pilot program, many 

applicants coordinated their trip to an 

Enrollment Center with their travel at 

the airport. We have used one hour of 

travel time so as not to underestimate 

potential opportunity costs for enrolling 

in the program. We use a value of 

$28.60 for the opportunity cost for this 

time, which is taken from the Federal 

Aviation Administration’s ‘‘Economic 

Values for FAA Investment and 

Regulatory Decisions, A Guide.’’ (July 

3, 2007). This value is the weighted 

average for U.S. business and leisure 

travelers. For this evaluation, we 

assume that all enrollees will be U.S. 

citizens, U.S. nationals, or Lawful 

Permanent Residents. 

Timetable: 

Action Date FR Cite 

NPRM 11/19/09 74 FR 59932 

NPRM Comment 

Period End 

01/19/10 

Final Rule 02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

URL For More Information: 

www.globalentry.gov 

Agency Contact: 

John P. Wagner 

Director, Trusted Traveler Programs 

Department of Homeland Security 

U.S. Customs and Border Protection 

Office of Field Operations 

1300 Pennsylvania Avenue NW. 

Washington, DC 20229 

Phone: 202 344–2118 

RIN: 1651–AA73 

DHS—USCBP 

80. IMPLEMENTATION OF THE 

GUAM–CNMI VISA WAIVER 

PROGRAM 

Priority: 

Other Significant. Major under 5 USC 

801. 

Legal Authority: 

PL 110–229, sec 702 

CFR Citation: 

8 CFR 100.4; 8 CFR 212.1; 8 CFR 233.5; 

8 CFR 235.5; 19 CFR 4.7b; 19 CFR 

122.49a 

Legal Deadline: 

Final, Statutory, November 4, 2008, PL 

110–229. 

Abstract: 

This rule amends Department of 

Homeland Security (DHS) regulations 

to implement section 702 of the 

Consolidated Natural Resources Act of 

2008 (CNRA). This law extends the 

immigration laws of the United States 

to the Commonwealth of the Northern 

Mariana Islands (CNMI) and provides 

for a joint visa waiver program for 

travel to Guam and the CNMI. This rule 

implements section 702 of the CNRA 

by amending the regulations to replace 

the current Guam Visa Waiver Program 

with a new Guam-CNMI Visa Waiver 

Program. The amended regulations set 

forth the requirements for 

nonimmigrant visitors who seek 

admission for business or pleasure and 

solely for entry into and stay on Guam 

or the CNMI without a visa. This rule 

also establishes six ports of entry in 

the CNMI for purposes of administering 

and enforcing the Guam-CNMI Visa 

Waiver Program. 

Statement of Need: 

Currently, aliens who are citizens of 

eligible countries may apply for 

admission to Guam at a Guam port of 

entry as nonimmigrant visitors for a 

period of fifteen (15) days or less, for 

business or pleasure, without first 

obtaining a nonimmigrant visa, 

provided that they are otherwise 

eligible for admission. Section 702(b) of 

the Consolidated Natural Resources Act 

of 2008 (CNRA), supersedes the Guam 

visa waiver program by providing for 

a visa waiver program for Guam and 

the Commonwealth of the Northern 

Mariana Islands (Guam-CNMI Visa 

Waiver Program). Section 702(b) 

requires DHS to promulgate regulations 

within 180 days of enactment of the 

CNRA to allow nonimmigrant visitors 

from eligible countries to apply for 

admission into Guam and the CNMI, 

for business or pleasure, without a visa, 

for a period of authorized stay of no 

longer than forty-five (45) days. 

Summary of Legal Basis: 

The Guam-CNMI Visa Waiver Program 

is based on congressional authority 

provided under 702(b) of the 

Consolidated Natural Resources Act of 

2008 (CNRA). 

Alternatives: 

None 

Anticipated Cost and Benefits: 

The most significant change for 

admission to the CNMI as a result of 

the rule will be for visitors from those 

countries who are not included in 

either the existing U.S. Visa Waiver 

Program or the Guam-CNMI Visa 

Waiver Program established by the rule. 

These visitors must apply for U.S. 

visas, which require in-person 

interviews at U.S. embassies or 

consulates and higher fees than the 

CNMI currently assesses for its visitor 


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entry permits. CBP anticipates that the 

annual cost to the CNMI will be $6 

million. These are losses associated 

with the reduced visits from foreign 

travelers who may no longer visit the 

CNMI upon implementation of this 

rule. 

The anticipated benefits of the rule are 

enhanced security that will result from 

the federalization of the immigration 

functions in the CNMI. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 01/16/09 74 FR 2824 

Interim Final Rule 

Effective 

01/16/09 

Interim Final Rule 

Comment Period 

End 

03/17/09 

Technical 

Amendment; 

Change of 

Implementation 

Date 

05/28/09 74 FR 25387 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Agency Contact: 

Cheryl C. Peters 

Department of Homeland Security 

U.S. Customs and Border Protection 

1300 Pennsylvania Avenue NW. 

Washington, DC 20229 

Phone: 202 344–1707 

Email: cheryl.c.peters@dhs.gov 

Related RIN: Related to 1651–AA81 

RIN: 1651–AA77 

DHS—Transportation Security 

Administration (TSA) 

PROPOSED RULE STAGE 

81. LARGE AIRCRAFT SECURITY 

PROGRAM, OTHER AIRCRAFT 

OPERATOR SECURITY PROGRAM, 

AND AIRPORT OPERATOR SECURITY 

PROGRAM 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

6 USC 469; 18 USC 842; 18 USC 845; 

46 USC 70102 to 70106; 46 USC 70117; 

49 USC 114; 49 USC114(f)(3); 49 USC 

5103; 49 USC 5103a; 49 USC 40113; 

49 USC 44901 to 44907; 49 USC 44913 

to 44914; 49 USC 44916 to 44918; 49 

USC 44932; 49 USC 44935 to 44936; 

49 USC 44942; 49 USC 46105 

CFR Citation: 

49 CFR 1515; 49 CFR 1520; 49 CFR 

1522; 49 CFR 1540; 49 CFR 1542; 49 

CFR 1544; 49 CFR 1550 

Legal Deadline: 

None 

Abstract: 

On October 30, 2008, the 

Transportation Security Administration 

(TSA) issued a Notice of Proposed 

Rulemaking (NPRM), proposing to 

amend current aviation transportation 

security regulations to enhance the 

security of general aviation by 

expanding the scope of current 

requirements, and by adding new 

requirements for certain large aircraft 

operators and airports serving those 

aircraft. TSA also proposed that all 

aircraft operations, including corporate 

and private charter operations, with 

aircraft having a maximum certificated 

takeoff weight (MTOW) above 12,500 

pounds (‘‘large aircraft’’) be required to 

adopt a large aircraft security program. 

TSA also proposed to require certain 

airports that serve large aircraft to 

adopt security programs. TSA is 

preparing a supplemental NPRM 

(SNPRM), which will include a 

comment period for public comments. 

After considering comments received 

on the NPRM and meeting with 

stakeholders, TSA decided to revise the 

original proposal to tailor security 

requirements to the general aviation 

industry. TSA is considering 

alternatives to the following proposed 

provisions in the SNPRM: (1) The type 

of aircraft subject to TSA regulation; (2) 

compliance oversight; (3) watch list 

matching of passengers; (4) prohibited 

items; (5) scope of the background 

check requirements and the procedures 

used to implement the requirement; 

and (6) other issues. Additionally, in 

the SNPRM, TSA plans to propose 

security measures for foreign aircraft 

operators. U.S. and foreign operators 

would implement commensurate 

measures under the proposed rule. 

Statement of Need: 

This rule would enhance current 

security measures and might apply 

security measures currently in place for 

operators of certain types of aircraft to 

operators of other aircraft, including 

general aviation operators. While the 

focus of TSA’s existing aviation 

security programs has been on air 

carriers and commercial operators, TSA 

is aware that general aviation aircraft 

of sufficient size and weight may inflict 

significant damage and loss of lives if 

they are hijacked and used as missiles. 

TSA has current regulations that apply 

to large aircraft operated by air carriers 

and commercial operators, including 

the twelve-five program, the partial 

program, and the private charter 

program. However, the current 

regulations in 49 CFR part 1544 do not 

cover all general aviation operations, 

such as those operated by corporations 

and individuals, and such operations 

do not have the features that are 

necessary to enhance security. 

Therefore, TSA is preparing a SNPRM 

which proposes to establish new 

security measures for operators, 

including general aviation operators, 

that are not covered under TSA’s 

current regulations. 

Summary of Legal Basis: 

49 U.S.C. 114, 40113, 44903. 

Alternatives: 

DHS considered continuing to use 

voluntary guidance to secure general 

aviation, but determined that to ensure 

that each aircraft operator maintains an 

appropriate level of security, these 

security measures would need to be 

mandatory requirements. 

Anticipated Cost and Benefits: 

This proposed rule would yield 

benefits in the areas of security and 

quality governance. The rule would 

enhance security by expanding the 

mandatory use of security measures to 

certain operators of large aircraft that 

are not currently required to have a 

security plan. These measures would 

deter malicious individuals from 

perpetrating acts that might 

compromise transportation or national 

security by using large aircraft for these 

purposes. 

As stated above, TSA is revising this 

proposed rule and preparing a SNPRM. 

Aircraft operators, passengers, and TSA 

would incur costs to comply with the 

requirements of the proposed rule. TSA 

is currently evaluating the costs of the 

revised rule which will be published 

in the SNPRM. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79562 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Risks: 

This rulemaking addresses the national 

security risk of general aviation aircraft 

being used as a weapon or as a means 

to transport persons or weapons that 

could pose a threat to the United 

States. 

Timetable: 

Action Date FR Cite 

NPRM 10/30/08 73 FR 64790 

NPRM Comment 

Period End 

12/29/08 

Notice—NPRM 

Comment Period 

Extended 

11/25/08 73 FR 71590 

NPRM Extended 

Comment Period 

End 

02/27/09 

Notice—Public 

Meetings; Requests 

for Comments 

12/28/08 73 FR 77045 

Supplemental NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Local 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Additional Information: 

Public Meetings held on: Jan. 6, 2009, 

at White Plains, NY; Jan. 8, 2009, at 

Atlanta, GA; Jan 16, 2009, at Chicago, 

IL; Jan. 23, 2009, at Burbank, CA; and 

Jan. 28, 2009, at Houston, TX. 

Additional Comment Sessions held in 

Arlington, VA, on April 16, 2009, May 

6, 2009, and June 15, 2009. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Erik Jensen 

Assistant General Manager, General 

Aviation Security 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ, E10–132S 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–2154 

Fax: 571 227–1923 

Email: erik.jensen@dhs.gov 

Holly Merwin 

Economist, Regulatory Development and 

Economic Analysis 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ, E10–343N 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–4656 

Fax: 571 227–1362 

Email: holly.merwin@dhs.gov 

Mai Dinh 

Assistant Chief Counsel, Regulations and 

Security Standards Division 

Department of Homeland Security 

Transportation Security Administration 

Office of the Chief Counsel 

TSA–2, HQ, E12–309N 

601 South 12th Street 

Arlington, VA 20598–6002 

Phone: 571 227–2725 

Fax: 571 227–1378 

Email: mai.dinh@dhs.gov 

Kiersten Ols 

Attorney, Regulations and Security 

Standards Division 

Department of Homeland Security 

Transportation Security Administration 

Office of the Chief Counsel 

TSA–2, HQ, E12–316N 

601 South 12th Street 

Arlington, VA 20598–6002 

Phone: 571 227–2403 

Fax: 571 227–1378 

Email: kiersten.ols@dhs.gov 

Related RIN: Related to 1652–AA03, 

Related to 1652–AA04 

RIN: 1652–AA53 

DHS—TSA 

82. PUBLIC TRANSPORTATION AND 

PASSENGER RAILROADS—SECURITY 

TRAINING OF EMPLOYEES 

Priority: 

Other Significant. Major under 5 USC 

801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

49 USC 114; PL 110–53, secs 1408 and 

1517 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

Final, Statutory, November 1, 2007, 

Interim Rule for public transportation 

agencies is due 90 days after date of 

enactment. 

Final, Statutory, February 3, 2008, Rule 

for railroads is due 6 months after date 

of enactment. 

Final, Statutory, August 3, 2008, Rule 

for public transportation agencies is 

due 1 year after date of enactment. 

According to section 1408 of Public 

Law 110-53, Implementing 

Recommendations of the 9/11 

Commission Act of 2007 (Aug. 3, 2007; 

121 Stat. 266), interim final regulations 

for public transportation agencies are 

due 90 days after the date of enactment 

(Nov. 1, 2007), and final regulations are 

due 1 year after the date of enactment 

of this Act.According to section 1517 

of the same Act, final regulations for 

railroads are due no later than 6 

months after the date of enactment of 

this Act. 

Abstract: 

The Transportation Security 

Administration (TSA) will propose a 

new regulation to improve the security 

of public transportation and passenger 

railroads in accordance with the 

Implementing Recommendations of the 

9/11 Commission Act of 2007. This 

rulemaking will propose general 

requirements for a public transportation 

security training program and a 

passenger railroad training program to 

prepare public transportation and 

passenger railroad employees, 

including frontline employees, for 

potential security threats and 

conditions. 

Statement of Need: 

A security training program for public 

transportation agencies and for 

passenger railroads is proposed to 

prepare public transportation and 

passenger railroad employees, 

including frontline employees, for 

potential security threats and 

conditions. 

Summary of Legal Basis: 

49 U.S.C. 114; sections 1408 and 1517 

of Public Law 110-53, Implementing 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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Recommendations of the 9/11 

Commission Act of 2007 (Aug. 3, 2007; 

121 Stat. 266). 

Alternatives: 

TSA is required by statute to publish 

regulations requiring security programs 

for these operators. As part of its notice 

of proposed rulemaking, TSA will seek 

public comment on the numerous ways 

in which the final rule could carry out 

the requirements of the statute. 

Anticipated Cost and Benefits: 

TSA will estimate the costs that the 

public transportation agencies and 

passenger railroads covered by this 

proposed rule would incur following its 

implementation. These costs will 

include estimates for the following 

elements: 1) creating or modifying a 

security training program and 

submitting it to TSA; 2) training (initial 

and recurrent) all security-sensitive 

employees; 3) maintaining records of 

employee training; 4) being available 

for inspections; 5) providing 

information on security coordinators 

and alternates; and 6) reporting security 

concerns. TSA will also estimate the 

costs TSA itself would expect to incur 

with the implementation of this rule. 

The primary benefit of the Security 

Training NPRM will be to enhance 

United States surface transportation 

security by reducing the vulnerability 

of public transportation agencies and 

passenger railroads to terrorist activity 

through the training of securitysensitive employees. TSA uses a breakeven analysis to assess the trade-off 

between the beneficial effects of the 

Security Training NPRM and the costs 

of implementing the rulemaking. This 

break-even analysis uses scenarios 

extracted from the TSA Transportation 

Sector Security Risk Assessment 

(TSSRA) to determine the degree to 

which the Security Training NPRM 

must reduce the overall risk of a 

terrorist attack in order for the expected 

benefits of the NPRM to justify the 

estimated costs. For its analyses, TSA 

uses scenarios with varying levels of 

risk, but only details the consequence 

estimates. To maintain consistency, 

TSA developed the analyses with a 

method similar to that used for the 

break-even analyses conducted in 

earlier DHS rules. 

After estimating the total consequence 

of each scenario by monetizing lives 

lost, injuries incurred, capital 

replacement and clean-up, and lost 

revenue, TSA will use this figure and 

the annualized cost of the NPRM for 

public transportation and passenger rail 

to calculate a breakeven annual 

likelihood of attack. 

Risks: 

The Department of Homeland Security 

aims to prevent terrorist attacks within 

the United States and to reduce the 

vulnerability of the United States to 

terrorism. By providing for security 

training for personnel, TSA intends in 

this rulemaking to reduce the risk of 

a terrorist attack on this transportation 

sector. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Morvarid Zolghadr 

Branch Chief, Policy and Plans, Mass 

Transit and Passenger Rail Security 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, E10–113S 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–2957 

Fax: 571 227–0729 

Email: morvarid.zolghadr@dhs.gov 

Nicholas (Nick) Acheson 

Sr. Economist, Regulatory Development 

and Economic Analysis 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ, E10–341N 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–5474 

Fax: 703 603–0302 

Email: nicholas.acheson@dhs.gov 

David Kasminoff 

Sr. Counsel, Regulations and Security 

Standards Division 

Department of Homeland Security 

Transportation Security Administration 

Office of the Chief Counsel 

TSA–2, HQ, E12–310N 

601 South 12th Street 

Arlington, VA 20598–6002 

Phone: 571 227–3583 

Fax: 571 227–1378 

Email: david.kasminoff@dhs.gov 

Related RIN: Related to 1652–AA57, 

Related to 1652–AA59 

RIN: 1652–AA55 

DHS—TSA 

83. FREIGHT RAILROADS—SECURITY 

TRAINING OF EMPLOYEES 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

49 USC 114; PL 110–53, sec 1517 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

Final, Statutory, February 3, 2008, Rule 

is due 6 months after date of 

enactment. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79564 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

According to section 1517 of Public 

Law 110-53, Implementing 

Recommendations of the 9/11 

Commission Act of 2007 (Aug. 3, 2007; 

121 Stat. 266), TSA must issue a 

regulation no later than 6 months after 

the date of enactment of this Act. 

Abstract: 

The Transportation Security 

Administration (TSA) will propose new 

regulations to improve the security of 

freight railroads in accordance with the 

Implementing Recommendations of the 

9/11 Commission Act of 2007. The 

rulemaking will propose general 

requirements for a security training 

program to prepare freight railroad 

employees, including frontline 

employees, for potential security threats 

and conditions. The regulations will 

take into consideration any current 

security training requirements or best 

practices. 

Statement of Need: 

The rulemaking will propose general 

requirements for a security training 

program to prepare freight railroad 

employees, including frontline 

employees, for potential security threats 

and conditions. 

Summary of Legal Basis: 

49 U.S.C. 114; section 1517 of Public 

Law 110-53, Implementing 

Recommendations of the 9/11 

Commission Act of 2007 (Aug. 3, 2007; 

121 Stat. 266). 

Alternatives: 

TSA is required by statute to publish 

regulations requiring security programs 

for these operators. As part of its notice 

of proposed rulemaking, TSA will seek 

public comment on the numerous ways 

in which the final rule could carry out 

the requirements of the statute. 

Anticipated Cost and Benefits: 

TSA will estimate the costs that the 

freight rail systems covered by this 

proposed rule would incur following its 

implementation. These costs will 

include estimates for the following 

elements: 1) Creating or modifying a 

security training program and 

submitting it to TSA; 2) training (initial 

and recurrent) all security-sensitive 

employees; 3) maintaining records of 

employee training; 4) being available 

for inspections; 5) providing 

information on security coordinators 

and alternates; and 6) reporting security 

concerns. TSA will also estimate the 

costs TSA itself would expect to incur 

with the implementation of this rule. 

The primary benefit of the Security 

Training NPRM will be to enhance 

United States surface transportation 

security by reducing the vulnerability 

of freight railroad systems to terrorist 

activity through the training of securitysensitive employees. TSA uses a breakeven analysis to assess the trade-off 

between the beneficial effects of the 

Security Training NPRM and the costs 

of implementing the rulemaking. This 

break-even analysis uses scenarios 

extracted from the TSA Transportation 

Sector Security Risk Assessment 

(TSSRA) to determine the degree to 

which the Security Training NPRM 

must reduce the overall risk of a 

terrorist attack in order for the expected 

benefits of the NPRM to justify the 

estimated costs. For its analyses, TSA 

uses scenarios with varying levels of 

risk, but only details the consequence 

estimates. To maintain consistency, 

TSA developed the analyses with a 

method similar to that used for the 

break-even analyses conducted in 

earlier DHS rules. 

After estimating the consequence of 

each scenario by monetizing lives lost, 

injuries incurred, capital replacement 

and clean-up, and lost revenue, TSA 

will use this figure and the annualized 

cost of the NPRM for freight rail to 

calculate a breakeven annual likelihood 

of attack. 

Risks: 

The Department of Homeland Security 

aims to prevent terrorist attacks within 

the United States and to reduce the 

vulnerability of the United States to 

terrorism. By providing for security 

training for personnel, TSA intends in 

this rulemaking to reduce the risk of 

a terrorist attack on this transportation 

sector. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Scott Gorton 

Policy and Plans Branch Chief for Freight 

Rail 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ, E10–423N 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–1251 

Fax: 571 227–2930 

Email: scott.gorton@dhs.gov 

Nicholas (Nick) Acheson 

Sr. Economist, Regulatory Development 

and Economic Analysis 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ, E10–341N 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–5474 

Fax: 703 603–0302 

Email: nicholas.acheson@dhs.gov 

David Kasminoff 

Sr. Counsel, Regulations and Security 

Standards Division 

Department of Homeland Security 

Transportation Security Administration 

Office of the Chief Counsel 

TSA–2, HQ, E12–310N 

601 South 12th Street 

Arlington, VA 20598–6002 

Phone: 571 227–3583 

Fax: 571 227–1378 

Email: david.kasminoff@dhs.gov 

Related RIN: Related to 1652–AA55, 

Related to 1652–AA59 

RIN: 1652–AA57 

DHS—TSA 

84. OVER–THE–ROAD BUSES— 

SECURITY TRAINING OF EMPLOYEES 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

49 USC 114; PL 110–53, sec 1534 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

Final, Statutory, February 3, 2008, Rule 

due 6 months after date of enactment. 

According to section 1534 of Public 

Law 110-53, Implementing 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79565 

Recommendations of the 9/11 

Commission Act of 2007 (Aug. 3, 2007); 

121 Stat. 266), TSA must issue a 

regulation no later than 6 months after 

date of enactment of this Act. 

Abstract: 

The Transportation Security 

Administration (TSA) will propose new 

regulations to improve the security of 

over-the-road buses in accordance with 

the Implementing Recommendations of 

the 9/11 Commission Act of 2007. The 

rulemaking will propose an over-theroad bus security training program to 

prepare over-the-road bus frontline 

employees for potential security threats 

and conditions. The regulations will 

take into consideration any current 

security training requirements or best 

practices. 

Statement of Need: 

The rulemaking will propose an overthe-road bus security training program 

to prepare over-the-road bus frontline 

employees for potential security threats 

and conditions. 

Summary of Legal Basis: 

49 U.S.C. 114; section 1534 of Public 

Law 110-53, Implementing 

Recommendations of the 9/11 

Commission Act of 2007 (Aug. 3, 2007; 

121 Stat. 266). 

Alternatives: 

TSA is required by statute to publish 

regulations requiring security programs 

for these operators. As part of its notice 

of proposed rulemaking, TSA will seek 

public comment on the numerous ways 

in which the final rule could carry out 

the requirements of the statute. 

Anticipated Cost and Benefits: 

TSA will estimate the costs that the 

commercial over-the-road bus (OTRB) 

entities covered by this proposed rule 

would incur following its 

implementation. These costs will 

include estimates for the following 

elements: 1) Creating or modifying a 

security training program and 

submitting it to TSA; 2) training (initial 

and recurrent) all security-sensitive 

employees; 3) maintaining records of 

employee training; 4) being available 

for inspections; 5) providing 

information on security coordinators 

and alternates; and 6) reporting security 

concerns. TSA will also estimate the 

costs TSA itself would expect to incur 

with the implementation of this rule. 

The primary benefit of the Security 

Training NPRM will be to enhance 

United States surface transportation 

security by reducing the vulnerability 

of commercial OTRB operators to 

terrorist activity through the training of 

security-sensitive employees. TSA uses 

a break-even analysis to assess the 

trade-off between the beneficial effects 

of the Security Training NPRM and the 

costs of implementing the rulemaking. 

This break-even analysis uses scenarios 

extracted from the TSA Transportation 

Sector Security Risk Assessment 

(TSSRA) to determine the degree to 

which the Security Training NPRM 

must reduce the overall risk of a 

terrorist attack in order for the expected 

benefits of the NPRM to justify the 

estimated costs. For its analyses, TSA 

uses scenarios with varying levels of 

risk, but only details the consequence 

estimates. To maintain consistency, 

TSA developed the analyses with a 

method similar to that used for the 

break-even analyses conducted in 

earlier DHS rules. 

After estimating the consequence of 

each scenario by monetizing lives lost, 

injuries incurred, capital replacement 

and clean-up, and lost revenue, TSA 

will use this figure and the annualized 

cost of the NPRM for OTRB operators 

to calculate a breakeven annual 

likelihood of attack. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Steve Sprague 

Highway Passenger, Infrastructure and 

Licensing Branch Chief; Highway and 

Motor Carrier Programs 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ, E 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–1468 

Email: steve.sprague@dhs.gov 

Shaina Pereira 

Economist, Regulatory Development and 

Economic Analysis 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ, E10–339N 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–5138 

Fax: 571 227–1362 

Email: shaina.pereira@dhs.gov 

Traci Klemm 

Attorney, Regulations and Security 

Standards Division 

Department of Homeland Security 

Transportation Security Administration 

Office of the Chief Counsel 

TSA–2, E12–335N 

601 South 12th Street 

Arlington, VA 20598–6002 

Phone: 571 227–3596 

Email: traci.klemm@dhs.gov 

Related RIN: Related to 1652–AA55, 

Related to 1652–AA57 

RIN: 1652–AA59 

DHS—TSA 

FINAL RULE STAGE 

85. AIRCRAFT REPAIR STATION 

SECURITY 

Priority: 

Other Significant. Major under 5 USC 

801. 

Legal Authority: 

49 USC 114; 49 USC 44924 

CFR Citation: 

49 CFR 1554 

Legal Deadline: 

Final, Statutory, August 8, 2004, Rule 

within 240 days of the date of 

enactment of Vision 100. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79566 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Final, Statutory, August 3, 2008, Rule 

within 1 year after the date of 

enactment of 9/11 Commission Act. 

Section 611(b)(1) of Vision 100— 

Century of Aviation Reauthorization 

Act (Pub. L. 108-176; Dec. 12, 2003; 

117 Stat. 2490), codified at 49 U.S.C. 

44924, requires TSA issue ‘‘final 

regulations to ensure the security of 

foreign and domestic aircraft repair 

stations.’’ Section 1616 of the 

Implementing Recommendations of the 

9/11 Commission Act of 2007 (Pub. L. 

110—531; Aug. 3, 2007; 21 Stat. 266) 

requires TSA issue a final rule on 

foreign repair station security. 

Abstract: 

The Transportation Security 

Administration (TSA) proposed to add 

a new regulation to improve the 

security of domestic and foreign aircraft 

repair stations, as required by the 

section 611 of Vision 100—Century of 

Aviation Reauthorization Act and 

section 1616 of the 9/11 Commission 

Act of 2007. The regulation proposed 

general requirements for security 

programs to be adopted and 

implemented by repair stations 

certificated by the Federal Aviation 

Administration (FAA). A notice of 

proposed rulemaking (NPRM) was 

published in the Federal Register on 

November 18, 2009, requesting public 

comments to be submitted by January 

19, 2010. The comment period was 

extended to February 19, 2010, on 

request of the stakeholders to allow the 

aviation industry and other interested 

entities and individuals additional time 

to complete their comments. 

Statement of Need: 

The Transportation Security 

Administration (TSA) is proposing 

regulations to improve the security of 

domestic and foreign aircraft repair 

stations. The NPRM proposed to 

require repair stations that are 

certificated by the Federal Aviation 

Administration to adopt and carry out 

a security program. The proposal will 

codify the scope of TSA’s existing 

inspection program. The proposal also 

provides procedures for repair stations 

to seek review of any TSA 

determination that security measures 

are deficient. 

Summary of Legal Basis: 

Section 611(b)(1) of Vision 100— 

Century of Aviation Reauthorization 

Act (Pub. L. 108-176; Dec. 12, 2003; 

117 Stat. 2490), codified at 49 U.S.C. 

44924, requires TSA to issue ‘‘final 

regulations to ensure the security of 

foreign and domestic aircraft repair 

stations’’ within 240 days from date of 

enactment of Vision 100. Section 1616 

of Public Law 110-53, Implementing 

Recommendations of the 9/11 

Commission Act of 2007 (Aug. 3, 2007; 

121 Stat. 266) requires that the FAA 

may not certify any foreign repair 

stations if the regulations are not 

issued within 1 year after the date of 

enactment of the 9/11 Commission Act 

unless the repair station was previously 

certificated or is in the process of 

certification. 

Alternatives: 

TSA is required by statute to publish 

regulations requiring security programs 

for aircraft repair stations. As part of 

its notice of proposed rulemaking, TSA 

sought public comment on the 

numerous alternative ways in which 

the final rule could carry out the 

requirements of the statute. 

Anticipated Cost and Benefits: 

TSA anticipates costs to aircraft repair 

stations mainly related to the 

establishment of security programs, 

which may include adding such 

measures as access controls, a 

personnel identification system, 

security awareness training, the 

designation of a security coordinator, 

employee background verification, and 

contingency plan. The total 10-year 

undiscounted cost of the program is 

$344 million. The discounted at 7 

percent, 10-year cost of the program is 

$241 million. Security coordinator costs 

of $132 million and training costs of 

$132 million represent the largest 

portions of the program. 

A major line of defense against an 

aviation-related terrorist act is the 

prevention of explosives, weapons, 

and/or incendiary devices from getting 

on board a plane. To date, efforts have 

been primarily related to inspection of 

baggage, passengers, and cargo, and 

security measures at airports that serve 

air carriers. With this rule, attention is 

given to aircraft that are located at 

repair stations, and to aircraft parts that 

are at repair stations, themselves to 

reduce the likelihood of an attack 

against aviation and the country. Since 

repair station personnel have direct 

access to all parts of an aircraft, the 

potential exists for a terrorist to seek 

to commandeer or compromise an 

aircraft when the aircraft is at one of 

these facilities. Moreover, as TSA 

tightens security in other areas of 

aviation, repair stations increasingly 

may become attractive targets for 

terrorist organizations attempting to 

evade aviation security protections 

currently in place. 

Risks: 

The Department of Homeland Security 

aims to prevent terrorist attacks within 

the United States and to reduce the 

vulnerability of the United States to 

terrorism. By requiring security 

programs for aircraft repair stations, 

TSA will focus on preventing 

unauthorized access to repair work and 

to aircraft to prevent sabotage or 

hijacking. 

Timetable: 

Action Date FR Cite 

Notice—Public 

Meeting; Request 

for Comments 

02/24/04 69 FR 8357 

Report to Congress 08/24/04 

NPRM 11/18/09 74 FR 59873 

NPRM Comment 

Period End 

01/19/10 

NPRM Comment 

Period Extended 

12/29/09 74 FR 68774 

NPRM Extended 

Comment Period 

End 

02/19/10 

Final Rule 05/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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Agency Contact: 

Celio Young 

Program Manager, Repair Stations 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management, General Aviation Division 

TSA–28, HQ, E5 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–3580 

Fax: 571 227–1362 

Email: celio.young@dhs.gov 

Thomas (Tom) Philson 

Manager, Economic Analysis 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ, E10–411N 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–3236 

Fax: 571 227–1362 

Email: thomas.philson@dhs.gov 

Linda L. Kent 

Assistant Chief Counsel, Regulations and 

Security Standards Division 

Department of Homeland Security 

Transportation Security Administration 

Office of the Chief Counsel 

TSA–2, HQ, E12–126S 

601 South 12th Street 

Arlington, VA 20598–6002 

Phone: 571 227–2675 

Fax: 571 227–1381 

Email: linda.kent@dhs.gov 

RIN: 1652–AA38 

DHS—TSA 

86. AIR CARGO SCREENING 

Priority: 

Other Significant. Major under 5 USC 

801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

PL 110–53, sec 1602; 49 USC 114; 49 

USC 40113; 49 USC 44901 to 44905; 

49 USC 44913 to 44914; 49 USC 44916; 

49 USC 44935 to 44936; 49 USC 46105 

CFR Citation: 

49 CFR 1520; 49 CFR 1522; 49 CFR 

1540; 49 CFR 1544; 49 CFR 1548; 49 

CFR 1549 

Legal Deadline: 

Other, Statutory, February 3, 2009, 

Screen 50 percent of cargo on passenger 

aircraft. 

Other, Statutory, August 3, 2010, 

Screen 100 percent of cargo on 

passenger aircraft. 

Final, Statutory, November 3, 2010, 1 

year after effective date of the interim 

final rule. 

Section 1602 of the Implementing 

Recommendations of the 9/11 

Commission Act of 2007 (Pub. L. 110- 

53, 121 Stat. 266, 478, Aug. 3, 2007) 

requires that the Secretary of Homeland 

Security establish a system to screen 

50 percent of cargo on passenger 

aircraft NLT 18 months after the date 

of enactment and 100 percent of such 

cargo NLT 3 years after the date of 

enactment. The 9/11 Act also requires 

that TSA issue a final rule NLT 1 year 

after the effective date of the interim 

final rule (Nov. 2010). 

Abstract: 

On September 16, 2009, the 

Transportation Security Administration 

(TSA) issued an Interim Final Rule 

(IFR) that established the Certified 

Cargo Screening Program (CCSP) that 

certifies shippers, manufacturers, and 

other entities to screen air cargo 

intended for transport on a passenger 

aircraft. This is the primary means 

through which TSA will meet the 

requirements of section 1602 of the 

Implementing Recommendations of the 

9/11 Commission Act of 2007 that 

mandates that 100 percent of air cargo 

transported on passenger aircraft, 

operated by an air carrier or foreign air 

carrier in air transportation or intrastate 

air transportation, be screened by 

August 2010, to ensure the security of 

all such passenger aircraft carrying 

cargo. 

Under this rulemaking, each certified 

cargo screening facility (CCSF) and its 

employees and authorized 

representatives that will be screening 

cargo must successfully complete a 

security threat assessment. The CCSF 

must also submit to an assessment of 

their security measures by TSAapproved validators, screen cargo using 

TSA-approved methods, and initiate 

strict chain of custody measures to 

ensure the security of the cargo 

throughout the supply chain prior to 

tendering it for transport on passenger 

aircraft. 

TSA will issue a final rule responding 

to public comments from the IFR. 

Statement of Need: 

TSA is establishing a system to screen 

100 percent of cargo transported on 

passenger aircraft operated by an air 

carrier or foreign air carrier in air 

transportation or intrastate air 

transportation to ensure the security of 

all such passenger aircraft carrying 

cargo. 

The system shall require, at a 

minimum, that equipment, technology, 

procedures, personnel, or other 

methods approved by the Administrator 

of TSA, used to screen cargo carried 

on passenger aircraft, provide a level 

of security commensurate with the 

level of security for the screening of 

passenger checked baggage. 

Summary of Legal Basis: 

49 U.S.C. 114; section 1602 of the 

Implementing Recommendations of the 

9/11 Commission Act of 2007 (Pub. L. 

110-53, 121 Stat. 266, 478, 10/3/2007), 

codified at 49 U.S.C. 44901(g). 

Alternatives: 

The Interim Final Rule (IFR) states that 

as an alternative to establishing the 

CCSP, TSA considered meeting the 

statutory requirements by having 

aircraft operators screen cargo intended 

for transportation on passenger 

aircraft—that is, continuing the current 

cargo screening program but expanding 

it to 85 percent of air cargo on 

passenger aircraft, with the remaining 

15 percent assumed to be shipped via 

other modes. Under this alternative, the 

cost drivers are screening equipment, 

personnel for screening, training of 

personnel, and delays. Delays are the 

largest cost component, totaling $7.0 

billion over 10 years, undiscounted. In 

summary, 

the undiscounted 10 year cost of the 

alternative is $11.1 billion, and 

discounted at 7 percent, the cost is $7.7 

billion. 

Anticipated Cost and Benefits: 

TSA estimates the cost of the rule will 

be $1.9 billion (discounted at 7 percent) 

over 10 years. TSA analyzed the 

alternative of not establishing the 

Certified Cargo Screening Program 

(CCSP) and, instead, having aircraft 

operators and air carriers perform 

screening of all cargo transported on 

passenger aircraft. Absent the CCSP, the 

estimated cost to aircraft operators and 

air carriers is $7.7 billion (discounted 

at 7 percent) over 10 years. 

The bulk of the costs for both the CCSP 

and the alternative are attributed to 

personnel and the impact of cargo 

delays resulting from the addition of 

a new operational process. 

The benefits of the FR are five-fold. 

First, passenger air carriers will be 

more firmly protected against an act of 

terrorism or other malicious behaviors 

by the screening of 100 percent of cargo 


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shipped on passenger aircraft. Second, 

allowing the screening process to occur 

throughout the supply chain via the 

Certified Cargo Screening 

Program will reduce potential 

bottlenecks and delays at the airports. 

Third, the FR will allow market forces 

to identify the most efficient venue for 

screening along the supply chain, as 

entities upstream from the aircraft 

operator may apply to become CCSFs 

and screen cargo. Fourth, the CCSP 

enables members to screen 

valuable cargo earlier in the supply 

chain and avoid any potentially 

invasive screening that may occur at 

the aircraft operator level. Finally, 

validation firms will perform 

assessments of the entities that become 

CCSFs, allowing TSA to set priorities 

for compliance inspections. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 09/16/09 74 FR 47672 

Interim Final Rule 

Comment Period 

End 

11/16/09 

Interim Final Rule 

Effective 

11/16/09 

Final Rule 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Federal 

Agency Contact: 

Victor Parker 

Branch Chief, Air Cargo Policy & Plans 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–3664 

Email: victor.parker@dhs.gov 

Adam Sicking 

Economist, Regulatory Development and 

Economic Analysis 

Department of Homeland Security 

Transportation Security Administration 

Office of Transportation Sector Network 

Management 

TSA–28, HQ, E10–345N 

601 South 12th Street 

Arlington, VA 20598–6028 

Phone: 571 227–2304 

Fax: 571 227–1362 

Email: adam.sicking@dhs.gov 

Alice Crowe 

Sr. Attorney, Regulations and Security 

Standards Division 

Department of Homeland Security 

Transportation Security Administration 

Office of the Chief Counsel 

TSA–2, HQ, E12–320N 

601 South 12th Street 

Arlington, VA 20598–6002 

Phone: 571 227–2652 

Fax: 571 227–1379 

Email: alice.crowe@dhs.gov 

RIN: 1652–AA64 

DHS—U.S. Immigration and Customs 

Enforcement (USICE) 

PROPOSED RULE STAGE 

87. CONTINUED DETENTION OF 

ALIENS SUBJECT TO FINAL ORDERS 

OF REMOVAL 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Legal Authority: 

8 USC 1103; 8 USC 1223; 8 USC 1227; 

8 USC 1231; 8 USC 1253 

CFR Citation: 

8 CFR 241 

Legal Deadline: 

None 

Abstract: 

This notice of proposed rulemaking 

(NPRM) is proposing to amend the 

Department of Homeland Security 

(DHS) regulatory provisions for custody 

determinations for aliens in 

immigration detention who are subject 

to an administratively final order of 

removal. The proposed amendment 

would add a paragraph to 8 CFR 

241.4(g) providing that U.S. 

Immigration and Customs Enforcement 

(ICE) shall have a reasonable period of 

time to effectuate an alien’s removal 

where the alien is not in immigration 

custody when the order of removal 

becomes administratively final. The 

proposed rule would also clarify the 

removal period time frame afforded to 

the agency following an alien’s 

compliance with his or her obligations 

regarding removal subsequent to a 

period of obstruction or failure to 

cooperate. The rule proposes to make 

conforming changes to 241.13(b)(2). 

Lastly, the rule proposes to add a 

paragraph to 8 CFR 241.13(b)(3) to 

make clear that aliens certified by the 

Secretary under section 236A of the 

Immigration and Nationality Act, 8 

U.S.C. 1226a, are not subject to the 

provisions of 8 CFR 241.13, in 

accordance with the separate detention 

standard provided under the Act. 

Statement of Need: 

The companion final rule will improve 

the post order custody review process 

in the final rule related to the Detention 

of Aliens Subject to Final Orders of 

Removal in light of the U.S. Supreme 

Court’s decisions in Zadvydas v. Davis, 

533 U.S. 678 (2001), Clark v. Martinez, 

543 U.S. 371 (2005) and conforming 

changes as required by the enactment 

of the Homeland Security Act of 2002 

(HSA). This notice of proposed 

rulemaking (NPRM) will propose to 

amend 8 CFR 241.1(g) to provide for 

a new 90-day removal period once an 

alien comes into compliance with his 

or her obligation to make timely 

application in good faith for travel or 

other documents and not conspire or 

act to prevent removal. 

Anticipated Cost and Benefits: 

This proposed rule will clarify the 

regulatory provisions concerning the 

removal of aliens that are subject to an 

administratively final order of removal. 

DHS does not anticipate there will be 

cost impacts to the public as a result 

of the rule. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 


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Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Agency Contact: 

Jason Johnsen 

Department of Homeland Security 

U.S. Immigration and Customs 

Enforcement 

500 12th Street SW. 

Washington, DC 20024 

Phone: 202 732–4245 

Email: jason.johnsen@dhs.gov 

Related RIN: Related to 1653–AA13 

RIN: 1653–AA60 

DHS—USICE 

FINAL RULE STAGE 

88. CONTINUED DETENTION OF 

ALIENS SUBJECT TO FINAL ORDERS 

OF REMOVAL 

Priority: 

Other Significant 

Legal Authority: 

8 USC 1103; 8 USC 1223; 8 USC 1227; 

8 USC 1231; 8 USC 1253; . . . 

CFR Citation: 

8 CFR 241 

Legal Deadline: 

None 

Abstract: 

The U.S. Department of Homeland 

Security is finalizing, with 

amendments, the interim rule that was 

published on November 14, 2001, by 

the former Immigration and 

Naturalization Service (Service). The 

interim rule included procedures for 

conducting custody determinations in 

light of the U.S. Supreme Court’s 

decision in Zadvydas v. Davis, 533 U.S. 

678 (2001), which held that the 

detention period of certain aliens who 

are subject to a final administrative 

order of removal is limited under 

section 241(a)(6) of the Immigration 

and Nationality Act (Act) to the period 

reasonably necessary to effect their 

removal. The interim rule amended 

section 241.4 of title 8, Code of Federal 

Regulations (CFR), in addition to 

creating two new sections: 8 CFR 

241.13 (establishing custody review 

procedures based on the significant 

likelihood of the alien’s removal in the 

reasonably foreseeable future) and 

241.14 (establishing custody review 

procedures for special circumstances 

cases). Subsequently, in the case of 

Clark v. Martinez, 543 U.S. 371 (2005), 

the Supreme Court clarified a question 

left open in Zadvydas, and held that 

section 241(a)(6) of the Act applies 

equally to all aliens described in that 

section. This rule amends the interim 

rule to conform to the requirements of 

Martinez. Further, the procedures for 

custody determinations for postremoval period aliens who are subject 

to an administratively final order of 

removal, and who have not been 

released from detention or repatriated, 

have been revised in response to 

comments received and experience 

gained from administration of the 

interim rule published in 2001. This 

final rule also makes conforming 

changes as required by the enactment 

of the Homeland Security Act of 2002 

(HSA). Additionally, certain portions of 

the final rule were determined to 

require public comment and, for this 

reason, have been developed into a 

separate/companion notice of proposed 

rulemaking; RIN 1653-AA60. 

Statement of Need: 

This rule will improve the post order 

custody review process in the final rule 

related to the Detention of Aliens 

Subject to Final Orders of Removal in 

light of the U.S. Supreme Court’s 

decisions in Zadvydas v. Davis, 533 

U.S. 678 (2001), Clark v. Martinez, 543 

U.S. 371 (2005) and conforming 

changes as required by the enactment 

of the Homeland Security Act of 2002 

(HSA). A companion notice of 

proposed rulemaking (NPRM) will 

propose to amend 8 CFR 241.1(g) to 

provide for a new 90-day removal 

period once an alien comes into 

compliance with his or her obligation 

to make timely application in good 

faith for travel or other documents and 

not conspire or act to prevent removal. 

Anticipated Cost and Benefits: 

The changes are administrative and 

procedural in nature, and will not 

result in cost impacts to the public. The 

benefits of making these changes to the 

regulations will allow for expedited 

review of the post-order custody review 

process. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 11/14/01 66 FR 56967 

Action Date FR Cite 

Interim Final Rule 

Comment Period 

End 

01/14/02 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Additional Information: 

INS No. 2156-01 

Transferred from RIN 1115-AG29 

Agency Contact: 

Jason Johnsen 

Department of Homeland Security 

U.S. Immigration and Customs 

Enforcement 

500 12th Street SW. 

Washington, DC 20024 

Phone: 202 732–4245 

Email: jason.johnsen@dhs.gov 

RIN: 1653–AA13 

DHS—USICE 

89. EXTENDING PERIOD FOR 

OPTIONAL PRACTICAL TRAINING BY 

17 MONTHS FOR F–1 NONIMMIGRANT 

STUDENTS WITH STEM DEGREES 

AND EXPANDING THE CAP–GAP 

RELIEF FOR ALL F–1 STUDENTS 

WITH PENDING H–1B PETITIONS 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Legal Authority: 

8 USC 1101 to 1103; 8 USC 1182; 8 

USC 1184 to 1187; 8 USC 1221; 8 USC 

1281 and 1282; 8 USC 1301 to 1305 

CFR Citation: 

8 CFR 214 

Legal Deadline: 

None 

Abstract: 

Currently, foreign students in F-1 

nonimmigrant status who have been 

enrolled on a full-time basis for at least 

one full academic year in a college, 

university, conservatory, or seminary 

certified by U.S. Immigration and 

Custom Enforcement’s (ICE) Student 

and Exchange Visitor Program (SEVP) 

are eligible for 12 months of optional 

practical training (OPT) to work for a 


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U.S. employer in a job directly related 

to the student’s major area of study. 

The maximum period of OPT is 29 

months for F-1 students who have 

completed a science, technology, 

engineering, or mathematics (STEM) 

degree and accept employment with 

employers enrolled in U.S. Citizenship 

and Immigration Services’ (USCIS’) EVerify employment verification 

program. Employers of F-1 students 

with an extension of post-completion 

OPT authorization must report to the 

student’s designated school official 

(DSO) within 48 hours after the OPT 

student has been terminated from, or 

otherwise leaves, his or her 

employment with that employer prior 

to end of the authorized period of OPT. 

The final rule will respond to public 

comments and may make adjustments 

to the regulations. 

Statement of Need: 

ICE will improve SEVP processes by 

publishing the Final Optional Practical 

Training (OPT) rule, which will 

respond to comments on the OPT 

interim final rule (IFR). The IFR 

increased the maximum period of OPT 

from 12 months to 29 months for 

nonimmigrant students who have 

completed a science, technology, 

engineering, or mathematics (STEM) 

degree and who accept employment 

with employers who participate in the 

U.S. Citizenship and Immigration 

Services’ (USCIS’) E-Verify employment 

verification program. 

Alternatives: 

DHS is considering several alternatives 

to the 17-month extension of OPT and 

cap-gap extension, ranging from taking 

no action to further extension for a 

larger populace. The interim final rule 

addressed an immediate competitive 

disadvantage faced by U.S. industries 

and ameliorated some of the adverse 

impacts on the U.S. economy. DHS 

continues to evaluate both quantitative 

and qualitative alternatives. 

Anticipated Cost and Benefits: 

Based on an estimated 12,000 students 

per year that will receive an OPT 

extension and an estimated 5,300 

employers that will need to enroll in 

E-verify, DHS projects that this rule 

will cost students approximately $1.49 

million per year in additional 

information collection burdens, 

$4,080,000 in fees, and cost employers 

$1,240,000 to enroll in E-Verify and 

$168,540 per year thereafter to verify 

the status of new hires. However, this 

rule will increase the availability of 

qualified workers in science, 

technology, engineering, and 

mathematical fields; reduce delays that 

place U.S. employers at a disadvantage 

when recruiting foreign job candidates, 

thereby improving strategic and 

resource planning capabilities; increase 

the quality of life for participating 

students, and increase the integrity of 

the student visa program. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 04/08/08 73 FR 18944 

Interim Final Rule 

Comment Period 

End 

06/09/08 

Final Rule 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

None 

URL For More Information: 

www.dhs.gov/sevis/ 

Agency Contact: 

Sharon Snyder 

Acting Branch Chief, SEVP Policy, 

Student and Exchange Visitor Program 

Department of Homeland Security 

U.S. Immigration and Customs 

Enforcement 

Potomac Center North 

500 12th Street SW. 

Washington, DC 20024–6121 

Phone: 703 603–3415 

RIN: 1653–AA56 

DHS—Federal Emergency 

Management Agency (FEMA) 

PROPOSED RULE STAGE 

90. UPDATE OF FEMA’S PUBLIC 

ASSISTANCE REGULATIONS 

Priority: 

Other Significant 

Legal Authority: 

42 USC 5121 to 5207 

CFR Citation: 

44 CFR 206 

Legal Deadline: 

None 

Abstract: 

This proposed rule would revise the 

Federal Emergency Management 

Agency’s Public Assistance program 

regulations. Many of these changes 

reflect amendments made to the Robert 

T. Stafford Disaster Relief and 

Emergency Assistance Act by the PostKatrina Emergency Management Reform 

Act of 2006 and the Security and 

Accountability For Every Port Act of 

2006. The proposed rule also proposes 

to reflect lessons learned from recent 

events, and propose further substantive 

and non-substantive clarifications and 

corrections to improve upon the Public 

Assistance regulations. This proposed 

rule is intended to improve the 

efficiency and consistency of the Public 

Assistance program, as well as 

implement new statutory authority by 

expanding Federal assistance, 

improving the Project Worksheet 

process, empowering grantees, and 

improving State Administrative Plans. 

Statement of Need: 

The proposed changes implement new 

statutory authorities and incorporate 

necessary clarifications and corrections 

to streamline and improve the Public 

Assistance program. Portions of 

FEMA’s Public Assistance regulations 

have become out of date and do not 

implement all of FEMA’s available 

statutory authorities. The current 

regulations inhibit FEMA’s ability to 

clearly articulate its regulatory 

requirements, and the Public Assistance 

applicants’ understanding of the 

program. The proposed changes are 

intended to improve the efficiency and 

consistency of the Public Assistance 

program. 

Summary of Legal Basis: 

The legal authority for the changes in 

this proposed rule is contained in the 

Robert T. Stafford Disaster Relief and 

Emergency Assistance Act, 42 U.S.C. 

5121 to 5207, as amended by the PostKatrina Emergency Management Reform 

Act of 2006, 6 U.S.C. 701 et seq, the 

Security and Accountability For Every 

Port Act of 2006, 6 U.S.C. 901 note, 

the Local Community Recovery Act of 

2006, Public Law 109-218, 120 Stat. 

333, and the Pets Evacuation and 

Transportation Standards Act of 2006, 

Public Law 109-308, 120 Stat. 1725. 

Alternatives: 

One alternative is to revise some of the 

current regulatory requirements (such 

as application deadlines) in addition to 

implementing the amendments made to 

the Stafford Act by (1) the Post-Katrina 

Emergency Management Reform Act of 

2006 (PKEMRA), Public Law 109-295, 

120 Stat. 1394; 2) the Security and 

Accountability For Every Port Act of 

2006 (SAFE Port Act), Public Law 109- 


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347, 120 Stat. 1884; 3) the Local 

Community Recovery Act of 2006, 

Public Law 109-218, 120 Stat. 333; and 

4) the Pets Evacuation and 

Transportation Standards Act of 2006 

(PETS Act), Public Law 109-308, 120 

Stat. 1725. Another alternative is to 

expand funding by expanding force 

account labor cost eligibility to 

Category A Projects (debris removal). 

Anticipated Cost and Benefits: 

The proposed rule is expected to have 

economic impacts on the public, 

grantees, subgrantees, and FEMA. The 

expected benefits are a reduction in 

property damages, societal losses, and 

losses to local businesses, as well as 

improved efficiency and consistency of 

the Public Assistance program. The 

total economic impact of the proposed 

rule is estimated to be approximately 

$50 million per year (in 2010 dollars). 

The primary economic impact of the 

proposed rule is the additional transfer 

of funding from FEMA through the 

Public Assistance program to grantees 

and subgrantees that is effectuated by 

this rulemaking. The proposed rule will 

also incur additional administrative 

costs to grantees and FEMA, which is 

estimated to be approximately 

$230,000, and $20,000 per year, 

respectively. However, most of the 

proposed changes are not expected to 

result in any additional cost to FEMA 

or any changes in the eligibility of 

assistance. 

Risks: 

This action does not adversely affect 

public health, safety, or the 

environment. 

Timetable: 

Action Date FR Cite 

NPRM 04/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Federal, Local, State, Tribal 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Agency Contact: 

Tod Wells 

Recovery Directorate 

Department of Homeland Security 

Federal Emergency Management Agency 

500 C Street SW. 

Washington, DC 20472–3100 

Phone: 202 646–3936 

Fax: 202 646–3363 

Email: tod.wells@dhs.gov 

RIN: 1660–AA51 

BILLING CODE 9110–9B–S 


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DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT (HUD) 

Statement of Regulatory Priorities 

The Regulatory Plan for the 

Department of Housing and Urban 

Development (HUD) for Fiscal Year (FY) 

2011 highlights the most significant 

regulatory initiatives that HUD seeks to 

complete during the upcoming fiscal 

year. As the Federal agency that serves 

as the Nation’s housing agency, 

committed to addressing the housing 

needs of Americans, promoting 

economic and community development, 

and enforcing the Nation’s fair housing 

laws, HUD plays a significant role in the 

lives of families and communities 

throughout America. Through its 

programs, HUD works to strengthen the 

housing market and protect consumers; 

meet the need for quality affordable 

rental homes; utilize housing as a 

platform for improving quality of life; 

and build inclusive and sustainable 

communities free from discrimination. 

The state of America’s housing market 

plays a major role in shaping the wellbeing of individuals and families, the 

stability of neighborhoods, and the 

strength of America’s economy. That is 

why the recent downturn of the housing 

market—with high rates of foreclosure, 

increases in vacant properties, and 

plummeting home values—has been so 

devastating for families and 

communities alike. During this most 

recent downturn in the housing market, 

millions of families have lost their 

homes, and at least 3 million 

homeowners remain at risk of losing 

their homes. The effect of the crisis on 

neighborhoods has been no less 

dramatic. The high rate of foreclosures 

has undermined the stability of many 

neighborhoods across America. 

In 2009, HUD took a prominent role 

in the Administration’s Federal recovery 

strategy by helping American families 

keep their homes and stabilizing 

neighborhoods hard hit by foreclosure. 

In the midst of a credit crunch, HUD’s 

Federal Housing Administration (FHA) 

assisted nearly 1.95 million households 

in fiscal year 2009. HUD led efforts in 

foreclosure mitigation, homeownership 

counseling, and curbing mortgage abuse 

and lending discrimination. Through 

funds awarded to HUD under the 

American Recovery and Reinvestment 

Act, HUD provided grant funds to State 

and local governments and nonprofit 

organizations to stabilize communities 

and neighborhoods negatively affected 

by foreclosure. HUD’s efforts to help 

homeowners struggling to keep their 

homes and neighborhoods in distress 

did not abate in 2010. In 2010, HUD 

introduced its FHA Short Refinance 

option, which enables lenders to 

provide additional refinancing options 

to homeowners who owe more on their 

mortgages than their homes are worth. 

Through additional funding provided by 

Congress, HUD’s Neighborhood 

Stabilization program continues into 

2010 to help neighborhoods that have 

suffered from foreclosures. 

Although homeownership historically 

has been the primary vehicle by which 

American families have built wealth, 

the recent crisis has shown that 

homeownership at any cost is fraught 

with peril. Americans need sustainable 

homeownership in which the costs are 

appropriate for a family’s financial 

situation and the risks associated with 

homeownership are understood and 

manageable. In this regard, Secretary 

Donovan has directed that HUD must 

have a balanced, comprehensive 

national housing policy, one that 

supports and preserves sustainable 

homeownership, but also provides 

affordable rental housing, with a focus 

on preservation of developments that 

are integral to sustainability, such as 

those adjacent to significant 

transportation options, or with great 

access to jobs. Additionally, increasing 

affordable rental housing provides a 

means of addressing homelessness. 

While HUD continues with programs 

to stem foreclosures and stabilize 

neighborhoods, with signs suggesting 

that the Nation is on the road to 

recovery, HUD is better able to direct 

efforts to implement the Secretary’s 

balanced comprehensive national 

housing policy. HUD’s regulatory plan 

for FY 2011 reflects one step in 

achieving this balanced, comprehensive 

national housing policy and is based on 

major legislation recently enacted that 

supports such a policy. 

Priority: Providing Sustainable 

Homeownership Through Consumer 

Education 

Consumer protections help prevent 

borrowers from falling victim to 

fraudulent loan products and aggressive 

marketing techniques. Such products 

and techniques contributed to the 

current housing crisis. One way to assist 

consumers from falling victims to 

fraudulent loan products is to ensure 

that they fully understand the home 

purchase process and the benefits but 

also the ongoing costs of 

homeownership. Such consumer 

education over the years has been 

increasingly provided by housing 

counselors, individuals trained and 

experienced in assisting individuals 

with mortgage-related issues, personal 

finances, and how to avoid default and 

foreclosure. Through HUD-funded and 

HUD-approved housing counseling 

agencies, HUD helps ensure that 

prospective and current homeowners 

have access to needed counseling 

services, as well as for those who rent. 

The Dodd-Frank Wall Street Reform 

and Consumer Protection Act (Pub. L. 

111-203) signed into law by President 

Obama on July 21, 2010, recognizes the 

importance that housing counseling 

plays in protecting consumers from 

mortgage fraud and provides for the 

establishment of an Office of Housing 

Counseling within HUD. The new 

office’s responsibilities include ensuring 

that homeownership counseling 

addresses the entire process of 

homeownership, including the decision 

to purchase a home, the selection and 

purchase of a home, issues arising 

during or affecting the period of 

ownership of a home (including 

refinancing, default and foreclosure, and 

other financial decisions), and the sale 

or other disposition of a home. The new 

office will also oversee that HUDapproved counseling agencies provide 

counseling on the benefits and costs of 

renting. HUD’s new Office of Housing 

Counseling is charged with several other 

duties and responsibilities, and HUD’s 

FY 2011 regulatory plan includes the 

rulemaking that will provide the 

regulatory foundation for the new Office 

of Housing Counseling to carry out all 

of its important duties and 

responsibilities. 

Regulatory Action: Housing 

Counseling—New Program 

Requirements 

HUD will issue a rule that reflects the 

authority of HUD’s new Office of 

Housing Counseling. The Dodd-Frank 

Wall Street Reform and Consumer 

Protection Act provides that this office 

will establish, coordinate, and 

administer all regulations, requirements, 

standards, and performance measures 

under programs and laws administered 

by HUD that relate to housing 

counseling, homeownership counseling 

(including maintenance of homes), 

mortgage-related counseling (including 

home equity conversion mortgages and 

credit protection options to avoid 

foreclosure), and rental housing 

counseling, including the requirements, 

standards, and performance measures 

relating to housing counseling. The new 

law also directs HUD, through this 

office, to among other things, establish 

standards for the eligibility of 

organizations (including governmental 


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and nonprofit organizations) to receive 

HUD housing counseling grants; 

establish standards for materials and 

forms to be used, as appropriate, by 

organizations providing homeownership 

counseling services; provide for the 

certification of various computer 

software programs for consumers to use 

in evaluating different residential 

mortgage loan proposals; and ensure 

that counselors receiving funding under 

HUD’s housing counseling grant 

program are properly certified, in 

accordance with standards established 

by HUD. 

Priority: Improving Energy Efficiency in 

Housing 

Despite significant improvements in 

housing quality in recent decades, much 

of the Nation’s housing stock is not 

energy efficient. Increasing the Nation’s 

affordable housing stock must also 

include establishing or improving 

energy efficiency in such housing. HUD 

initiated new energy efficiency 

programs through the American 

Recovery and Reinvestment Act of 2009 

(Recovery Act). These included: A $250 

million Green Retrofit Program for 

assisted multifamily buildings; $600 

million for high performing energy 

retrofit and green projects in public 

housing; and additional formula and 

competitive programs that either 

contained incentives for energy 

efficiency and green, or could be 

utilized for that purpose. HUD estimates 

that up to 88,000 units may be 

retrofitted through these programs, for 

an estimated energy savings of $21 

million. 

While HUD’s programs and initiatives 

under the Recovery Act focused on 

public and assisted multifamily 

housing, HUD’s FY 2011 regulatory plan 

focuses on establishing a regulatory 

foundation to improve energy efficiency 

in FHA’s title I Property Improvement 

Loan Insurance program (Title I 

program). Through the Title I program, 

FHA makes it easier for consumers to 

obtain affordable home improvement 

loans by insuring loans made by private 

lenders to improve properties that meet 

certain requirements. Title I program 

loans may be used to finance permanent 

property improvements that protect or 

improve the basic livability or utility of 

the property. HUD’s FY 2011 

rulemaking for the Title I program will 

provide for qualified borrowers to 

obtain low cost loans for specified 

energy improvements. 

Regulatory Action: Title I Energy 

Retrofit Property Improvement Loans 

HUD’s rule amending the Title I 

program to provide for low cost loans 

for energy improvements has its 

foundation in the Recovery through 

Retrofit Report (Report), issued on 

October 19, 2009, by the Vice President 

and the White House Middle Class Task 

Force. The Report builds on the 

foundation laid out in the Recovery Act 

to expand green job opportunities in the 

United States and boost energy savings 

for middle class Americans by 

retrofitting homes for energy efficiency. 

The Report recognizes that making 

American homes and buildings more 

energy efficient presents an 

unprecedented opportunity for 

communities throughout the country. 

Home retrofits can potentially help 

people earn money, as home retrofit 

workers, while also helping them save 

money, by lowering their utility bills. 

The regulatory amendments to be 

addressed by this rulemaking will take 

into consideration the experience of 

HUD, Title I lenders, and consumers 

participating in HUD’s Title I program 

Energy Retrofit Loan Demonstration to 

be launched late 2010. The 

demonstration will allow HUD to assess 

the success of the proposed 

modifications to its existing Title I 

program and address any programmatic 

concerns before undertaking final 

codification of regulatory amendments. 

Aggregate Costs and Benefits 

Executive Order 12866, as amended, 

requires the agency to provide its best 

estimate of the combined aggregate costs 

and benefits of all regulations included 

in the agency’s regulatory plan that will 

be made effective in calendar year 2011. 

HUD expects that the neither the total 

economic costs nor the total efficiency 

gains will exceed $100 million. 

HUD—Office of Housing (OH) 

PROPOSED RULE STAGE 

91. ∑ TITLE I ENERGY RETROFIT 

PROPERTY IMPROVEMENT LOANS 

(FR–5445) 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Legal Authority: 

12 USC 1703; 42 USC 3535(d) 

CFR Citation: 

24 CFR 201 

Legal Deadline: 

None 

Abstract: 

This proposed rule would amend 

HUD’s regulations for the title I 

Property Improvement Loan Insurance 

program (Title I program) to better 

assist qualified borrowers obtain lowcost loans for specified energy 

improvements. Through the Title I 

program, FHA makes it easier for 

consumers to obtain affordable home 

improvement loans by insuring loans 

made by private lenders to improve 

properties that meet certain 

requirements. Title I program loans 

may be used to finance permanent 

property improvements that protect or 

improve the basic livability or utility 

of the property. The proposed rule is 

being issued in response to the 

Recovery through Retrofit Report 

(Report), issued on October 19, 2009, 

by the Vice President and the White 

House Middle Class Task Force. The 

Report builds on the foundation laid 

out in the American Recovery and 

Reinvestment Act (Pub. L. 111-5; 

approved February 17, 2009) to expand 

green job opportunities in the United 

States and boost energy savings for 

middle class Americans by retrofitting 

homes for energy efficiency. The Report 

recognizes that making American 

homes and buildings more energy 

efficient presents an unprecedented 

opportunity for communities 

throughout the country. Home retrofits 

can potentially help people earn 

money, as home retrofit workers, while 

also helping them save money, by 

lowering their utility bills. By 

encouraging nationwide weatherization 

of homes, workers of all skill levels 

will be trained, engaged, and will 

participate in ramping up a national 

home retrofit market. 

The proposed regulatory amendments 

build upon the experience of HUD, title 

I lenders and consumers participating 

in the Department’s Title I program 

Energy Retrofit Loan Demonstration. 

Before undertaking rulemaking to 

codify the regulatory amendments on 

a permanent, nationwide basis, HUD 

decided to conduct a demonstration 

involving a limited number of lenders 

and areas of the country. The 

demonstration will allow HUD to assess 

the success of the proposed 

modifications to the existing program 

and to address any programmatic 

concerns before authorizing its use 

throughout the country. 


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Statement of Need: 

The Report identified several barriers 

that have prevented a self-sustaining 

retrofit market from forming. Among 

other barriers, the Report found that 

homeowners face high upfront costs 

and many are concerned that they will 

be prevented from recouping the value 

of their investment if they choose to 

sell their home. The upfront costs of 

home retrofit projects are often beyond 

the average homeowner’s budget. The 

report found that the solution to the 

lack of home energy retrofit financing 

is to make such financing more 

accessible and more consumer friendly. 

The proposed regulatory amendments 

will help to address these needs by 

enabling qualified borrowers obtain 

title I low cost loans for energy-related 

home improvements. 

Summary of Legal Basis: 

The Title I program is authorized under 

title I, section 2, of the National 

Housing Act (12 U.S.C. 1703). 

Specifically, under section 2(a) of the 

National Housing Act, the Secretary of 

HUD is authorized to help homeowners 

finance alterations, repairs, and 

improvements in connection with 

existing structures or manufactured 

homes. HUD’s implementing 

regulations are codified at 24 CFR part 

201. 

Alternatives: 

The primary alternative HUD 

considered to amending the Title I 

regulations was use of the existing FHA 

Energy Efficient Mortgage (EEM) 

program. The FHA EEM program 

allows a borrower to finance and 

incremental amount on their first 

mortgage to invest in energy efficiency, 

with an additional appraisal or further 

credit qualification, provided that the 

benefit of projected energy savings 

exceed the cost of the improvements, 

as estimated by an energy audit, HUD 

ultimately determined that the EEM 

was not an optimal vehicle for 

achieving the energy innovation goals 

of this rule. First the FHA EEM is, by 

definition, a negative equity 

instrument, and negative equity is 

extremely problematic in the current 

housing market. Another problematic 

feature of the EEM program is that the 

financing may exceed the benefit from 

and useful life of the measures, and 

result in a total net cost to the 

consumer that does not represent the 

optimal use of funds. 

Anticipated Cost and Benefits: 

The aggregate net benefits are obtained 

by multiplying the individual net 

benefits by the expected number of 

loans and adding the expected social 

benefits of reduced energy 

consumption. As a base case, HUD 

assumes a consumer household with 

annual savings of $1000, a zero percent 

price growth and a 7 percent discount 

rate. The present value of a technical 

retrofit for this base case scenario is 

$11,400. Assuming a rebound effect of 

30 percent yields a comfort benefit of 

$3,400 and energy savings of $8,000 per 

participant (the ‘‘rebound effect’’ refers 

to the fact that the reaction of the 

consumer to the energy-saving 

technology will not necessarily reduce 

energy consumption by what is 

technically possible). Approximately 

24,000 loans are expected over two 

years. For the base case scenario, this 

would equal $41 million comfort 

benefits and $96 million in energy 

saving for each year of the program. 

The benefits of the FHA program may 

not equal the sum of the benefits of 

all retrofits financed through the 

program, but only reflect the benefits 

of the retrofits that would not have 

occurred without the program; 

however, the existence of significant 

market imperfections and the lack of 

affordable financing makes it 

reasonable to assume that a large 

proportion, if not all of the loans, will 

generate benefits. The cost of receiving 

the energy-savings is the upfront 

investment plus the costs of financing 

the investment. the cost per investment 

is thus equal to the size of the loan. 

Risks: 

This rule poses no risk to public health, 

safety, or the environment. 

Timetable: 

Action Date FR Cite 

NPRM 04/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Agency Contact: 

Karin Hill 

Director, Office of Single Family Program 

Development 

Department of Housing and Urban 

Development 

Office of Housing 

451 7th Street SW. 

Washington, DC 20410 

Phone: 202 708–4308 

RIN: 2502–AI93 

HUD—OH 

92. ∑ HOUSING COUNSELING: NEW 

PROGRAM REQUIREMENTS 

(FR–5446) 

Priority: 

Other Significant 

Legal Authority: 

12 USC 1701x; 42 USC 3535(d) 

CFR Citation: 

24 CFR 214 

Legal Deadline: 

None 

Abstract: 

This proposed rule would amend 

HUD’s regulations for the Housing 

Counseling program to address the new 

program requirements and certification 

requirements for HUD approved 

housing counselors as provided by the 

Dodd-Frank Wall Street Reform and 

Consumer Protection Act (Pub. L. 111- 

203, approved July 21, 2010). The 

proposed rule would also reflect the 

authority and responsibility of HUD’s 

new Office of Housing Counseling to 

coordinate and administer HUD’s 

Housing Counseling program. 

HUD’s Housing Counseling program is 

authorized by section 106 of the 

Housing and Urban Development Act 

of 1968 (12 U.S.C. 1701x). Section 106 

authorizes HUD to provide, make grants 

to, or contract with public or private 

organizations to provide a broad range 

of housing counseling services to 

homeowners and tenants to assist them 

in improving their housing conditions 

and in meeting the responsibilities of 

tenancy or homeownership. The 

regulations contained in this part 

prescribe the procedures and 

requirements by which the Housing 

Counseling program will be 

administered. These regulations apply 

to all agencies participating in HUD’s 

Housing Counseling program. 

The proposed regulatory amendments 

will implement the changes made to 


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section 106 of the Housing and Urban 

Development Act of 1968 by the DoddFrank Wall Street Reform and 

Consumer Protection Act, which 

include directing that HUD-approved 

housing counseling agencies provide 

counseling that addresses the entire 

process of homeownership and that 

HUD establish materials and forms to 

be used by HUD-approved housing 

counselors. 

Statement of Need: 

The rulemaking is needed because 

HUD’s current regulations for the 

Housing Counseling program do not 

reflect the changes made to section 106 

of section 106 of the Housing and 

Urban Development Act of 1968 by the 

Dodd-Frank Wall Street Reform. The 

changes enhance the choices and 

protections afforded borrowers 

participating in HUD’s single family 

mortgage insurance programs. 

Summary of Legal Basis: 

The Housing Counseling program is 

authorized by section 106 of the 

Housing and Urban Development Act 

of 1968 (12 U.S.C. 1701x), as recently 

amended by subtitle D of title XIV of 

the Dodd-Frank Wall Street Reform and 

Consumer Protection Act. 

Alternatives: 

As noted, the purpose of this rule is 

to update HUD’s regulations that do not 

reflect current statutory requirements. 

While certain statutory changes may be 

implemented through HUD’s annual 

competitive allocation of fund for the 

Housing Counseling program provided 

by appropriations acts, the regulation 

nevertheless needs to be amended to 

reflect the program changed made by 

changes to the underlying statutory 

authority. 

Anticipated Cost and Benefits: 

The benefit of the proposed regulatory 

amendments will be to strengthen the 

protection of consumers, primarily 

those who are prospective homeowners 

but also current homeowners through 

the enhanced counseling requirements 

provided by the Dodd-Frank Wall 

Street Reform and Consumer Protection 

Act. The more comprehensive 

counseling services directed to be 

provided and the review of materials 

and forms by HUD designed to better 

educate consumers about 

homeownership are expected to 

produce homebuyers better educated 

about the homeownership process and 

less vulnerable to fraudulent mortgage 

practices. Costs are expected to 

minimal. The Dodd-Frank Wall Street 

Reform and Consumer Protection Act 

authorizes funding to help establish 

HUD’s new Office of Housing 

Counseling and the additional 

functions to be carried out by this 

office. The Dodd-Frank Wall Street 

Reform and Consumer Protection Act 

also authorizes additional funding for 

the expansion of services to be carried 

out by HUD-approved counseling 

agencies. 

Risks: 

This rule poses no risk to public health, 

safety, or the environment. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Agency Contact: 

Ruth Roman 

Director, Office of Housing Counseling 

Department of Housing and Urban 

Development 

Office of Housing 

451 7th Street SW. 

Washington, DC 20410–0001 

Phone: 202 402–2112 

RIN: 2502–AI94 

BILLING CODE 4210–67–S 


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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 are 

responsible for relations with the island 

territories under United States 

jurisdiction. We manage more than 500 

million acres of Federal lands, including 

392 park units, 548 wildlife refuges, and 

approximately 1.7 billion of submerged 

offshore acres. This includes some of 

the highest quality renewable energy 

resources available to help the United 

States achieve the President’s goal of 

energy independence, including 

geothermal, solar, and wind. 

The Department protects and recovers 

endangered species; protects natural, 

historic, and cultural resources; 

manages water projects that are a life 

line and economic engine for many 

communities in the West; manages 

forests and fights wildfires; manages 

Federal energy resources; educates 

children in Indian schools; and provides 

recreational opportunities for over 400 

million visitors annually in our national 

parks, public lands, national wildlife 

refuges, and recreation areas. 

We will continue to review and 

update our regulations and policies to 

ensure that they are effective and 

efficient, and that they promote 

accountability and sustainability. We 

will emphasize regulations and policies 

that: 

• Promote environmentally responsible, 

safe, and balanced development of 

renewable and conventional energy 

on our public lands and the Outer 

Continental Shelf; 

• Use the best available science to 

ensure that public resources are 

protected, conserved, and used 

wisely; 

• Adopt performance approaches 

focused on achieving cost-effective, 

timely results; 

• Improve the nation-to-nation 

relationship with American Indian 

tribes; 

• Promote partnerships with States, 

tribes, local governments, other 

groups, and individuals to achieve 

common goals; 

• Promote transparency, fairness, 

accountability, and the highest ethical 

standards while maintaining 

performance goals. 

Major Regulatory Areas 

DOI bureaus implement legislatively 

mandated programs through their 

regulations. Some of these regulatory 

activities include: 

• Developing onshore and offshore 

energy, including renewable, 

minerals, oil and gas, and other 

energy resources; 

• Managing migratory birds and 

preserving marine mammals and 

endangered species; 

• Managing dedicated lands, such as 

national parks, wildlife refuges, 

National Landscape Conservation 

System lands, and American Indian 

trust lands; 

• Managing public lands open to 

multiple use; 

• Managing revenues from American 

Indian and Federal minerals; 

• Fulfilling trust and other 

responsibilities pertaining to 

American Indians; 

• Managing natural resource damage 

assessments; and 

• Managing assistance programs. 

Regulatory Policy 

How DOI regulatory priorities support 

the President’s energy, resource 

management, environmental 

sustainability, and economic recovery 

goals. 

DOI’s regulatory programs seek to 

operate programs transparently, 

efficiently, and cooperatively while 

maximizing protection of our land, 

resources, and environment in a fiscally 

responsible way by: 

(1) Protecting Natural, Cultural, and 

Heritage 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. Our 

priorities include protecting public 

health and safety, restoring and 

maintaining public lands, protecting 

threatened and endangered species, 

ameliorating land- and resourcemanagement problems on public lands, 

and ensuring accountability and 

compliance with Federal laws and 

regulations. 

The Bureau of Land Management 

(BLM) Wildlife Program continues to 

focus on maintaining and managing 

wildlife habitat to ensure self-sustaining 

populations and a natural abundance 

and diversity of wildlife resources on 

public lands. BLM-managed lands are 

vital to game species and hundreds of 

species of non-game mammals, reptiles, 

and amphibians. In order to provide for 

long-term protection of wildlife 

resources, especially given other 

mandated land use requirements, the 

Wildlife Program supports aggressive 

habitat conservation and restoration 

activities, many funded by partnerships 

with Federal, State, and nongovernmental organizations. For 

instance, the Wildlife Program is 

restoring wildlife habitat across a multiState region to support species that 

depend upon sagebrush vegetation. 

Projects are tailored to address regional 

issues such as fire (as in the western 

portion of the sagebrush biome) or 

habitat degradation and loss (as in the 

eastern portion of the sagebrush biome). 

Additionally, BLM undertakes habitat 

improvement projects in partnership 

with a variety of stakeholders and 

consistent with State fish and game 

wildlife action plans and local working 

group plans. 

The National Park Service (NPS) is 

working with BLM and the U.S. Fish 

and Wildlife Service to finalize a rule 

implementing Public Law 106-206, 

which directs the Secretary to establish 

a system of location fees for commercial 

filming and still photography activities 

on public lands. While commercial 

filming and still photography are 

generally allowed on Federal lands, 

managing this activity through a 

permitting process will minimize 

damage to cultural or natural resources 

and interference with other visitors to 

the area. This regulation would 

standardize location fee rates and 

collection for all DOI agencies. 

The Park Service is developing a new 

winter use regulation for Yellowstone 

and Grand Teton National Parks and the 

John D. Rockefeller, Jr., Memorial 

Parkway. This regulation will replace an 

interim rule expiring at the end of the 

2010 to 2011 winter season. It will 

establish an average daily entrance limit 

on the number of snowmobiles and 

snow coaches that may enter the park, 

and will continue the limit of 10 

snowmobiles for groups and guided 

tours. As the first steps toward 

developing this new rule, NPS will 

publish a proposed rule in the spring of 

2011. 

In 2008, in consultation with an 

interagency work group, NPS began 

developing a proposed rule to provide 

more efficient and cost-effective 

management of federally owned 

archaeological collections. At present, 


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there is no legal procedure to 

deaccession items in Federal collections 

that are of ‘‘insufficient archaeological 

interest;’’ i.e., they are of no further 

value to the science of archaeology or to 

the integrity of the collection in which 

they are contained. This rule would free 

up space in collections and allow 

custodians to allocate more time and 

effort to care of remaining items while 

ensuring proper disposition of those 

archaeological items. 

The rule also requires assigning a 

specific individual to be accountable for 

proper disposition. This complicated 

rule is now undergoing final review and 

should be ready for publication in early 

2011. 

(2) Sustainably Using Energy, Water, 

and Natural Resources. 

The Bureau of Land Management has 

identified a total of approximately 20.6 

million acres of public land with wind 

energy potential in the 11 western states 

and approximately 29.5 million acres 

with solar energy potential in the six 

southwestern states. There are over 140 

million acres of public land in western 

states and Alaska with geothermal 

resource potential. There is also 

significant wind and wave potential in 

our offshore waters. The National 

Renewable Energy Lab, a Department of 

Energy national laboratory, has 

identified more than 1,000 gigawatts of 

wind potential off the Atlantic coast— 

roughly equivalent to the Nation’s 

existing installed electric generating 

capacity—and more than 900 gigawatts 

of wind potential off the Pacific Coast. 

Because public lands are extensive and 

widely distributed, the Department has 

an important role, in consultation with 

Federal, State, regional, and local 

authorities, in siting new transmission 

lines needed to bring renewable energy 

assets to load centers. 

Since the beginning of the Obama 

Administration, the Department has 

focused on renewable energy issues and 

has established priorities for 

environmentally responsible 

development of renewable energy on 

our public lands and the outer 

continental shelf. Industry has started to 

respond by investing in development of 

wind farms off the Atlantic seacoast and 

solar, wind, and geothermal energy 

facilities throughout the west. Power 

generation from these new energy 

sources produces virtually no 

greenhouse gases, and when done in an 

environmentally sensitive manner, 

harnesses with minimum impact 

abundant, renewable energy that nature 

itself provides. The Department will 

continue its intra- and interdepartmental efforts to move forward 

with the environmentally responsible 

review and permitting of renewable 

energy projects on public lands. 

On March 11, 2009, the Secretary 

issued his first Secretarial Order that 

made facilitating production, 

development, and delivery of renewable 

energy on public lands and the OCS top 

priorities at the Department. In 

accomplishing these goals, the 

Department will protect our signature 

landscapes, natural resources, wildlife, 

and cultural resources and will 

collaborate with relevant Federal, State, 

tribal, and other agencies. The 

Secretarial Order also established an 

energy and climate change task force 

that draws from the leadership of each 

of the bureaus and is responsible for: 

• Quantifying potential contributions of 

renewable energy resources on our 

public lands and the OCS; and 

• Identifying and prioritizing specific 

areas on public lands where the 

Department can facilitate a rapid and 

responsible increase in production of 

renewable energy. 

On April 29, 2009, the former 

Minerals Management Service 

published a final rule to establish a 

program to grant leases, easements, and 

rights-of-way for renewable energy 

projects on the Outer Continental Shelf 

(OCS). These regulations will ensure the 

orderly, safe, and environmentally 

responsible development of renewable 

energy sources on the OCS. 

(3) Empowering People and 

Communities. 

The Department encourages public 

participation in the regulatory process 

by seeking public input on a variety of 

regulatory issues. For example, every 

year the Fish and Wildlife Service 

(FWS) establishes migratory bird 

hunting seasons in partnership with 

flyway councils composed of State fish 

and wildlife agencies. FWS also holds a 

series of public meetings to give other 

interested parties, including hunters 

and other groups, opportunities to 

participate in establishing the upcoming 

season’s regulations. 

Similarly, the Bureau of Land 

Management uses Resource Advisory 

Councils made up of affected parties to 

help prepare land management plans 

and regulations that it issues. 

The National Park Service (NPS) has 

begun revising its rules on non-Federal 

development of gas and oil in units of 

the National Park System. Of the 

approximately 700 gas and oil wells in 

13 NPS units, 55 per cent, or 385 wells, 

are exempt from current regulations. 

NPS is revising the regulations to 

improve protection of NPS resources 

and bring those 385 wells under the 

regulatory umbrella. NPS actively 

sought public input into designing the 

rule and published an Advance Notice 

of Proposed Rulemaking with a 

comment period from November 15, 

2009, through January 25, 2010. 

Interested members of the public were 

able to make suggestions on the content 

of the regulation, which NPS will 

consider in writing the proposed rule. 

After developing a proposed rule, NPS 

will solicit further public comment. 

NPS expects to publish a proposed rule 

in mid 2011. 

Accountability and Sustainability 

Through Regulatory Efficiency 

We are using the regulatory process to 

improve results while easing regulatory 

burdens. For instance, the Endangered 

Species Act (ESA) allows for delisting 

threatened and endangered species if 

they no longer need the protection of 

the ESA. We are working to identify 

species for which delisting or 

downlisting (reclassification from 

endangered to threatened) may be 

appropriate. 

The Fish and Wildlife Service has 

found that making listing decisions 

under the Endangered Species Act in 

Hawaii on a traditional, species-byspecies basis is inefficient, since very 

similar information and analysis would 

be repeated in each rule. To improve 

efficiency, FWS is making listing 

decisions for 48 species on the island of 

Kauai in one regulatory package. This 

allows the Service to address the 

existing backlog of candidate species 

more quickly. 

Most candidate species on the 

Hawaiian Islands face nearly identical 

threats and are only found in the few 

remaining native-dominated ecological 

communities. The impacts of these 

threats are well understood at the 

community level, while their impacts to 

the individual candidate species are 

relatively less studied. Because this 

ecological community approach focuses 

on conserving the key physical and 

biological components of native 

communities and ecosystems, it may 

preclude the need to list additional 

species found in the same ecological 

communities. Recovery plans developed 

in response to the Kauai listing will 

focus conservation efforts on protection 

and restoration of ecosystem processes, 

allowing us to more efficiently address 


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common threats in the most important 

areas. 

DOI bureaus work to make our 

regulations easier to comply with and 

understand. 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. Results include: 

• Effective stewardship of our Nation’s 

resources in a way that is responsive 

to the needs of small businesses; 

• Increased benefits per dollars spent by 

carefully evaluating the economic 

effects of planned rules; and 

• Improved compliance and 

transparency by use of plain language 

in our regulations and guidance 

documents. 

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) 

administers and manages 56 million 

acres of land held in trust by the United 

States for Indians and Indian tribes, 

providing services to approximately 1.9 

million Indians and Alaska Natives, and 

maintaining a government-togovernment relationship with the 565 

federally recognized Indian tribes. BIA’s 

mission is to enhance the quality of life, 

to promote economic opportunity, and 

to carry out the responsibility to protect 

and improve the trust assets of 

American Indians, Indian tribes, and 

Alaska Natives, as well as to provide 

quality education opportunities to 

students in Indian schools. 

In the coming year, BIA will continue 

its regulatory focus on improved 

management of trust responsibilities 

and promotion of economic 

development in Indian communities. In 

addition, we will focus on updating 

Indian education regulations and on 

other regulatory changes to increase 

transparency in support of the 

President’s Open Government Initiative. 

With the input of tribal leaders, 

individual Indian beneficiaries, and 

other subject matter experts, BIA has 

been examining ways to better serve its 

beneficiaries. The American Indian 

Probate Reform Act of 2004 (AIPRA) 

made clear that regulatory changes were 

necessary to update the manner in 

which we meet our trust management 

responsibilities. We have promulgated 

regulations implementing the probaterelated provisions of AIPRA and will 

now focus on regulations to implement 

other AIPRA provisions related to 

managing Indian land. 

The focus on promoting economic 

development in Indian communities is 

a core component of BIA’s mission. 

Economic development initiatives can 

attract businesses to Indian 

communities and fund services that 

support the health and well-being of 

tribal members.By providing the tools 

necessary to promote economic 

development, economic development 

can enable tribes to attain selfsufficiency, strengthen their 

governments, and reduce crime. 

Indian education is a top priority of 

the Assistant Secretary—Indian Affairs. 

For this reason, we will review Indian 

education regulations to ensure that 

they adequately support efforts to 

provide students of BIA-funded schools 

with the best education possible. 

Finally, BIA’s regulatory focus on 

increasing transparency implements the 

President’s Open Government Initiative. 

We will ensure that all regulations that 

we draft or revise meet high standards 

of readability and accurately and clearly 

describe BIA processes. 

BIA’s regulatory priorities are to: 

• Develop regulations to meet the 

Indian trust reform goals for land 

consolidation and land use 

management. 

BIA is developing amendments to 

regulations in the areas of land title 

and records, conveyances of trust or 

restricted land, leasing, grazing, 

trespass, rights-of-way, and energy 

and minerals. Together, these 

regulatory changes will provide the 

Department with the tools it needs to 

better serve beneficiaries and will 

standardize procedures for consistent 

execution of fiduciary responsibilities 

across the BIA. 

• Revise loan guaranty regulations to 

promote private investment in Indian 

Country. 

BIA plans to propose a rule that 

would address the chronic lack of 

business lending faced by Indian 

communities. While BIA currently 

operates a successful loan guaranty, 

insurance, and interest subsidy 

program, the program’s current 

regulations are best suited to assisting 

for-profit businesses to secure loans in 

the $250,000 to $10 million range. 

Revisions to the rule would: 

– Promote financing for smaller loans 

(under $250,000), which are 

important for sparking economic 

development, by allowing 

community development financial 

institutions to obtain program 

guarantees and insurance and by 

using fiscal transfer agents to 

encourage financing for small loans. 

– Obtain funding for higher cost 

projects (above $10 million)- 

including infrastructure projects, 

energy projects, and other large 

projects requiring a longer 

repayment horizon-by offering a 

Federal Government guarantee for 

taxable tribal bonds. The guarantee 

would help ensure bond placement, 

decrease market rates charged for 

bonds, and help tribes become 

established in the bond market. 

– Extend eligibility for the program to 

non-profit borrowers who make a 

significant economic contribution 

to the Indian reservation or tribal 

service area. 

These changes are authorized by the 

Indian Financing Act, as amended by 

the Native American Technical 

Corrections Act of 2006. 

• Identify and develop regulatory 

changes necessary for improved 

Indian education. 

BIA is currently reviewing regulations 

addressing grants to tribally 

controlled community colleges and 

other Indian education regulations. 

The review will identify provisions 

that need to be updated to comply 

with applicable statutes and ensure 

that the proper regulatory framework 

is in place to support students of 

Bureau-funded schools. 

• Develop regulatory changes to reform 

the process for Federal 

acknowledgment of Indian tribes. 

Over the years, BIA has received 

significant comments from American 

Indian groups and members of 

Congress on the Federal 

acknowledgment process established 

by 25 CFR part 83. Most of these 

comments claim that the current 

process is cumbersome and overly 

restrictive. BIA is reviewing the 

current Federal acknowledgment 

regulation and will develop any 

necessary regulatory changes. 

• Revise regulations governing 

administrative appeals and other 

processes to increase transparency. 

BIA is making a concentrated effort to 

improve the readability and precision 

of its regulations. Because trust 

beneficiaries often turn to the 

regulations for guidance on how a 

given BIA process works, BIA is 


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ensuring that each revised regulation 

is written as clearly as possible and 

accurately reflects the current 

organization of the Bureau. A few of 

the regulations BIA will be focusing 

this effort on include the regulation 

governing administrative appeals (25 

CFR part 2), the land use management 

regulations mentioned above, and 

regulations addressing various Indian 

services. 

The Bureau of Land Management 

The Bureau of Land Management 

(BLM) manages the 245-million-acre 

National System of Public Lands, 

located primarily in the western States, 

including Alaska, and the 700-millionacre subsurface mineral estate located 

throughout the Nation. BLM’s complex 

multiple-use mission affects the lives of 

a great number of Americans, including 

those who live near and visit the public 

lands, as well as millions of Americans 

who benefit from commodities, such as 

minerals, energy, or timber, produced 

from the lands’ rich resources. 

BLM’s multiple-use mission 

conserves the lands’ natural and 

cultural resources and sustains the 

health and productivity of the public 

lands for the use and enjoyment of 

present and future generations. BLM 

manages such varied uses as energy and 

mineral development, outdoor 

recreation, livestock grazing, and 

forestry and woodlands products. This 

year, BLM has celebrated the 10th 

anniversary of the National Landscape 

Conservation System (NLCS), created in 

2000 to highlight the conservation side 

of the Agency’s multiple-use mandate. 

Last year, Congress, through the passage 

of the Omnibus Public Land 

Management Act (Pub. L. 111-11), 

affirmed its support of BLM-managed 

NLCS in statute and added 929,000 

acres of wilderness, one national 

monument, four national conservation 

areas, 363 miles of wild and scenic 

rivers, and 40 miles of national scenic 

and historic trails to the NLCS. More 

than 880 NLCS treasured landscapes 

now span the Nation from Florida to 

Alaska. 

BLM is analyzing proposals for 

increasing renewable energy 

development on public lands. The 

quality of life that Americans enjoy 

today depends largely upon a stable and 

abundant supply of affordable energy. 

Because BLM manages more Federal 

land than any other agency—more than 

245 million surface acres and 700 

million subsurface acres of mineral 

estate—it plays a key role in ensuring 

that the Nation’s energy needs are met 

by managing both Federal renewable 

and non-renewable sources of energy. 

This is accomplished in an 

environmentally and fiscally sound way 

that protects our natural resources and 

critical wildlife habitat for such species 

as the sage-grouse and lynx. Although 

renewable energy can help reduce 

greenhouse gases, its development is not 

without environmental impacts. Large, 

commercial-scale solar energy plants, 

for example, can have long-term 

environmental impacts and may 

override other uses of the land. 

Another BLM priority is siting and 

authorizing transmission corridors to 

assist the national effort to move 

renewable energy from production sites 

to market. BLM has already 

accomplished a significant step in this 

direction by designating more than 

5,000 miles of energy transport corridors 

for the West-wide Energy Corridors. 

Development of actual transmission 

lines is done by authorizing rights-ofway across public lands. 

In an effort to prioritize its complex, 

multiple-use responsibilities, BLM has 

identified several emphasis areas to 

help explain its regulatory priorities. 

The following describes these programs 

and initiatives and reflects their 

interrelationship with the following 

priorities of the Secretary of the Interior: 

• Energy independence 

• Treasured landscapes 

• Native American Nations 

Treasured landscapes 

Protecting the landscapes of the 

National System of Public Lands 

involves numerous BLM programs as 

the Agency moves toward a holistic, 

landscape-level approach to managing 

multiple public land uses. BLM also 

engages partners interested in working 

on a broader scale across jurisdictional 

lines to achieve a common landscape 

vision. For the past several years, BLM, 

which manages the largest amount and 

the greatest diversity of fish and wildlife 

habitat of any Federal agency, has 

focused on restoring healthy landscapes 

in a number of ways, including: 

• Reducing the number of wild horses 

and burros on public lands, 

particularly in areas most affected by 

drought and wildfire. Maintaining the 

wild horse and burro population at 

appropriate management levels is 

critical in the effort to conserve forage 

resources that also sustain native 

wildlife and livestock. 

• Restoring habitat for sensitive, rare, 

threatened, and endangered species, 

such as sage-grouse, desert tortoise, 

and salmon. 

• Supporting greater biodiversity 

through noxious weed and invasive 

species treatments to bring back 

native plants. 

• Improving water quality by restoring 

riparian areas and protecting 

watersheds. Enhanced water quality 

aids in the restoration of habitat for 

fish and other aquatic and riparian 

species. 

• Conducting post-fire recovery efforts 

to promote healthy landscapes and 

discourage the spread of invasive 

species. 

Native American Nations 

BLM consults with Indian tribes on a 

government-to-government basis under 

multiple authorities and is continually 

working to assess and improve its tribal 

consultation practices. BLM held 

listening sessions throughout the West 

on this important issue in 2009 and 

2010 and received many valuable 

comments. BLM has continued its 

efforts to improve its tribal consultation 

practices by participating with the 

Department in multiple listening 

sessions with tribes throughout the 

country. 

The Native American Graves 

Protection and Repatriation Act 

(NAGPRA), enacted in 1990, addresses 

the rights of lineal descendants, Indian 

tribes, and Native Hawaiian 

organizations to certain Native 

American human remains, funerary 

objects, associated funerary objects, 

sacred objects, and objects of cultural 

patrimony with which they are 

affiliated. The statute and implementing 

regulations represent a careful balance 

between the legitimate interests of lineal 

descendants, Indian tribes, and Native 

Hawaiian organizations to control the 

remains of their ancestors and cultural 

property and the legitimate public 

interests in scientific and educational 

information associated with the human 

remains and cultural items. 

BLM is complying with the new 

NAGPRA regulations, including 

inventorying and repatriating human 

remains and other cultural items that 

are in BLM museum collections. BLM 

also consults with Indian tribes on 

implementing appropriate actions when 

human remains and other cultural items 

subject to NAGPRA are inadvertently 

discovered or intentionally excavated 

on the public lands. 

Additionally, BLM, in cooperation 

with the Bureau of Indian Affairs, helps 

tribes and individual Indian allottees 


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develop their solid and fluid mineral 

resources. BLM is responsible for 

development, product measurement, 

and inspection and enforcement of 

extracting operations of the mineral 

estate on trust properties. 

BLM’s regulatory priorities 

BLM’s regulatory focus is directed 

primarily by the priorities of the 

President and Congress, which include: 

• Facilitating domestic production of 

various sources of energy, including 

biomass, wind, solar, and other 

alternative sources. 

• Providing for a wide variety of public 

uses while maintaining the long-term 

health and diversity of the land. 

• Preserving significant natural, 

cultural, and historic resource values. 

• Understanding the arid, semi-arid, 

arctic, and other ecosystems that BLM 

manages. 

• Using the best scientific and technical 

information to make resource 

management decisions. 

• Understanding the needs of the 

people who use and enjoy BLMmanaged public lands and providing 

them with quality service. 

• Securing the recovery of a fair return 

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 developing regulations, BLM 

recognizes the need to ensure 

communication, coordination, and 

consultation with the public, including 

affected interests, tribes, and other 

stakeholders. BLM also works to draft 

regulations that are easy for the public 

to understand and that provide clarity to 

those most affected by them. 

BLM’s specific regulatory priorities 

include: 

Revising onshore oil and gas operating 

standards 

BLM expects to publish rules to revise 

several existing onshore oil and gas 

operating orders and propose one new 

onshore order. Onshore orders establish 

requirements and minimum standards 

and provide standard operating 

procedures. The orders are binding on 

operating rights owners and operators of 

Federal and Indian (except the Osage 

Nation) oil and gas leases and on all 

wells and facilities on State or private 

lands committed to Federal agreements. 

BLM is responsible for ensuring that oil 

or gas produced and sold from Federal 

or Indian leases is accurately measured 

for quantity and quality. The volume 

and quality of oil or gas sold from leases 

is key to determining the proper royalty 

to be paid by the lessee to the Office of 

Natural Resources Revenue. Existing 

Onshore Orders Number 3, 4, and 5 

would be revised to use new industry 

standards so that they reflect current 

operating procedures and to require that 

proper verification and accounting 

practices are used consistently. New 

Onshore Order Number 9 would cover 

waste prevention and beneficial use. 

The revisions would ensure that proper 

royalties are paid on oil and gas 

removed from Federal and Trust lands. 

Revising coal-management regulations 

BLM plans to publish a proposed rule 

to amend the coal-management 

regulations that pertain to the 

administration of Federal coal leases 

and logical mining units. The rule 

would primarily implement provisions 

of the Energy Policy Act of 2005 that 

pertain to administering coal leases. The 

rule also would clarify the royalty rate 

applicable to continuous highwall 

mining, a new coal-mining method in 

use on some Federal coal leases. 

Publishing rules on paleontological 

resources preservation 

The 2009 omnibus public lands law 

included provisions on permitting for 

the collection of paleontological 

resources. BLM and the National Park 

Service are co-leads of a team with the 

U. S. Forest Service that will be drafting 

a paleontological resources rule. The 

rule would address the protection of 

paleontological resources and how BLM 

would permit the collection of these 

resources. The rule would also address 

other issues such as administering 

permits, casual collection of rocks and 

minerals, hobby collection of common 

invertebrate plants and fossils, and civil 

and criminal penalties for violation of 

these rules. 

Revising the timber sale contract 

extension regulations 

BLM regulations currently allow 

timber sale contract extensions under 

very limited circumstances and 

specifically do not allow extensions for 

‘‘market fluctuations.’’ Nor do the 

regulations allow any reduction of 

contract value due to declines in the 

lumber market. BLM plans to publish a 

rule that would amend the forest 

product disposal regulations that 

pertain to the administration of forest 

product contracts. The recent decline in 

the housing industry has resulted in a 

more severe decline in the timber 

market than historically experienced, 

leaving many purchasers of BLM timber 

sale contracts without a reasonable 

market in which to sell harvested 

timber. The revised rule would allow 

BLM to extend contracts under specified 

circumstances. Regulatory changes 

would provide BLM more options to 

help maintain the logging and 

sawmilling infrastructure needed to 

manage the 66 million acres of timber 

and woodland resources on the public 

lands. 

The Bureau of Ocean Energy 

Management, Regulation and 

Enforcement 

On April 20, 2010, an explosion and 

fire erupted on an offshore drilling rig 

in the Gulf of Mexico called the 

Deepwater Horizon. As a result, the 

Secretary recommended a series of steps 

to immediately improve the safety of 

offshore oil and gas drilling operations 

in Federal waters and a suspension of 

certain permitting and drilling activities 

until the safety measures can be 

implemented and further analysis 

completed. Recommended actions 

include prescriptive near-term 

requirements, longer-term performancebased safety measures, and one or more 

Department-led working groups to 

evaluate longer-term safety issues. 

The Bureau of Ocean Energy 

Management, Regulation and 

Enforcement (BOEM) replaced the 

former Minerals Management Service 

(MMS) and will strengthen oversight 

and policing of offshore oil and gas 

development. The program is national 

in scope and has two major program 

offices: 

1) The Bureau of Ocean Energy 

Management will function as the 

resource manager for the conventional 

and renewable energy and mineral 

resources on the outer continental 

shelf (OCS). It will foster 

environmentally responsible and 

appropriate development of the OCS 

for both conventional and renewable 

energy and mineral resources in an 

efficient and effective manner that 

ensures fair market value for the 

rights conveyed. 

2) The Bureau of Safety and 

Environmental Enforcement will 

apply independent regulation, 

oversight, and enforcement powers to 

promote and enforce safety in offshore 

energy exploration and production 

operations and ensure that potentially 

negative environmental impacts on 

marine ecosystems and coastal 


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communities are appropriately 

considered and mitigated. 

In 2009, MMS completed a major 

milestone by developing and codifying 

the regulatory framework for renewable 

energy projects on the OCS. We are 

continuing to implement the regulatory 

provisions for developing the Nation’s 

offshore wind, wave, and ocean current 

resources in a safe and environmentally 

sound manner. 

Our regulatory focus for fiscal year 

2011 is directed by Presidential and 

legislative priorities that emphasize 

contributing to America’s energy 

supply, protecting the environment, and 

ensuring a fair return for taxpayers for 

energy production from Federal and 

Indian lands. 

Our regulatory priorities are to: 

• Establish New Requirements for 

Safety Measures for Oil and Gas 

Operations. 

This interim final rule published on 

October 15, 2010 (74 FR 63610). It 

implements certain safety measures 

outlined in a Safety Measures Report 

to the President dated May 27, 2010, 

which was prepared in response to 

the Deepwater Horizon event. The 

recommendations implemented in 

this interim rule revise regulations 

related to subsea and surface blowout 

preventers, well casing and 

cementing, secondary intervention, 

unplanned disconnects, 

recordkeeping, well completion, and 

well plugging. 

• Develop a Comprehensive Safety and 

Environmental Management Program 

for Offshore Operations and Facilities. 

Promulgate a final rule for all OCS oil 

and gas operations and facilities 

under BOEM’s jurisdiction including, 

but not limited to, drilling, 

production, construction, well 

workover, well completion, pipelines, 

fixed and floating facilities, mobile 

offshore drilling units, and lifting 

activities. This rule adds requirements 

for recordkeeping and documentation, 

hazards analysis, and job safety 

analysis for activities identified or 

discussed in the Safety and 

Environmental Management System 

program. It published on October 14, 

2010 (74 FR 63346). 

• Develop additional rules and 

regulations as a result of ongoing 

reviews of BOEMRE’s offshore 

regulatory regime. 

Several investigations and reviews of 

BOEMRE are being conducted by 

various agencies and entities— 

including the Safety Oversight Board, 

the Office of Inspector General, the 

President’s Deepwater Horizon 

Commission, the National Academy 

of Engineering, and the joint 

BOEMRE/USCG investigation of 

Deepwater Horizon. Some of these 

investigations and reviews focus 

narrowly on the Deepwater Horizon 

explosion; others are broader in focus 

and include many aspects of 

BOEMRE’s current regulatory system. 

We expect that recommendations for 

regulatory changes—both substantive 

and procedural—will be generated by 

these investigations and reviews, and 

will need to be reviewed, analyzed, 

and potentially incorporated in new 

or modified regulations. 

• Determine the proper value of coal for 

advanced royalty purposes. 

Implementing requirements in the 

Energy Policy Act of 2005, these 

regulations will provide clarification 

by re-designating and amending a 

BLM coal valuation directive. The 

rule will provide a needed alternative 

method to determine the value of coal 

for advanced royalty purposes. 

Office of Natural Resource Revenue 

The revenue responsibilities of the 

former MMS will now be located in the 

Office of Natural Resource Revenue 

(ONRR), which will continue to collect, 

account for, and disburse more than $13 

billion per year in revenues from 

Federal offshore energy and mineral 

leases and from onshore mineral leases 

on Federal and Indian lands. The 

program will operate Nationwide and 

will be primarily responsible for timely 

and accurate collection, distribution, 

and accounting for revenues associated 

with mineral and energy production. 

The regulatory program of ONRR will 

seek to: 

• Simplify valuation regulations. 

ONRR plans to simplify the 

regulations at 30 CFR part 206 for 

establishing the value for royalty 

purposes of oil, natural gas, coal, and 

geothermal produced from Federal and 

Indian leases. Additionally, the 

proposed rule would consolidate 

sections of the regulations common to 

all minerals such as definitions and 

instructions regarding how a payor 

should request a valuation 

determination. 

• Finalize debt collection regulations. 

ONRR is preparing regulations 

governing collection of delinquent 

royalties, rentals, bonuses, and other 

amounts due under Federal and 

Indian oil, gas, and other mineral 

leases. The regulations would include 

provisions for administrative offset 

and would clarify and codify the 

provisions of the Debt Collection Act 

of 1982 and the Debt Collection 

Improvement Act of 1996. 

• Continue to meet Indian trust 

responsibilities. 

ONRR has a trust responsibility to 

accurately collect and disburse oil 

and gas royalties on Indian lands. 

ONRR will increase royalty certainty 

by addressing oil valuation for Indian 

lands through a rulemaking process 

involving key stakeholders. 

U.S. Fish and Wildlife Service 

The mission of the U.S. Fish and 

Wildlife Service (FWS) 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. FWS also helps 

ensure a healthy environment for people 

by providing opportunities for 

Americans to enjoy the outdoors and 

our shared natural heritage. 

FWS fulfills its responsibilities 

through a diverse array of programs that: 

• Protect and recover threatened and 

endangered species; 

• Monitor and manage migratory birds; 

• Restore native aquatic populations 

and nationally significant fisheries; 

• Enforce Federal wildlife laws and 

regulate international trade; 

• Conserve and restore wildlife habitat 

such as wetlands; 

• Help foreign governments conserve 

wildlife through international 

conservation efforts; 

• Distribute Federal funds to States, 

territories, and tribes for fish and 

wildlife conservation projects; and 

• Manage the 96-million-acre National 

Wildlife Refuge System, which 

protects and conserves fish and 

wildlife and their habitats and allows 

the public to engage in outdoor 

recreational activities. 

Critical challenges to the work of FWS 

include global climate change; shortages 

of clean water suitable for wildlife; 

invasive species that are harmful to our 

fish, wildlife, and plant resources and 

their habitats; and the alienation of 

children and adults from the natural 

world. To address these challenges, 

FWS has identified six priorities: 

• The National Wildlife Refuge 

System—conserving our lands and 

resources; 

• Landscape conservation—working 

with others; 


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• Migratory birds—conservation and 

management; 

• Threatened and endangered species— 

achieving recovery and preventing 

extinction; 

• Connecting people with nature— 

ensuring the future of conservation; 

and 

• Aquatic species—the National Fish 

Habitat Action Plan (a plan that brings 

public and private partners together to 

restore U.S. waterways to sustainable 

health). 

To carry out these priorities, FWS has 

a large regulatory agenda that will, 

among other things: 

• List, delist, and reclassify species on 

the Lists of Endangered and 

Threatened Wildlife and Plants and 

designate critical habitat for certain 

listed species; 

• Update our regulations to carry out 

the Convention on International Trade 

in Wild Fauna and Flora; 

• Manage migratory bird populations; 

• Administer the subsistence program 

for harvest of fish and wildlife in 

Alaska; 

• Update our regulations governing the 

Wildlife and Sport Fish Restoration 

Program; and 

• Set forth hunting and sport fishing 

regulations for the National Wildlife 

Refuge System. 

National Park Service 

In November 2006, the National Park 

Service completed a nearly 10-year 

public process to develop a management 

plan for the Colorado River in Grand 

Canyon National Park. The Service is 

now implementing the plan by 

developing regulations that: Implement 

permit requirements for commercial 

river trips below a specified location in 

the canyon; update visitor use 

restrictions and camping closures; and 

eliminate unnecessary provisions in the 

current regulation. The proposed rule 

was published in the Federal Register 

on July13, 2009, and the public 

comment period ended on September 

11, 2009. The Service hopes to complete 

and publish a final rule by the end of 

2010. 

The National Park Service is working 

with the Bureau of Land Management 

and the Fish and Wildlife Service to 

finalize rules implementing Public Law 

106-206, which directs the Secretary to 

establish a reasonable fee system 

(location fees) for commercial filming 

and still photography activities on 

public lands. Although commercial 

filming and still photography are 

generally allowed on Federal lands, it is 

in the public’s interest to manage these 

activities through a permitting process. 

This will minimize the possibility of 

damage to the cultural or natural 

resources or interference with other 

visitors to the area. This regulation 

would standardize the collection of 

location fees by DOI agencies. 

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, we employ management, 

engineering, and science to achieve 

effective and environmentally sensitive 

solutions. 

Reclamation projects provide: 

Irrigation water service, municipal and 

industrial water supply, hydroelectric 

power generation, water quality 

improvement, groundwater 

management, fish and wildlife 

enhancement, outdoor recreation, flood 

control, navigation, river regulation and 

control, system optimization, and 

related uses. We have continued to 

focus on increased security at our 

facilities. 

Our regulatory program focus in fiscal 

year 2011 is to ensure that our mission 

and laws that require regulatory actions 

are carried out expeditiously, 

efficiently, and with an emphasis on 

cooperative problem solving by 

implementing two newly authorized 

programs: 

• Title I of Public Law 109-451 

authorizes establishment of a rural 

water supply program to enable the 

Bureau of Reclamation to coordinate 

with rural communities throughout 

the Western United States to identify 

their potable water supply needs and 

evaluate options for meeting those 

needs. Under the Act, we are 

finalizing a rule that will define how 

we will identify and work with 

eligible rural communities. We 

published an interim final rule on 

November 17, 2008, and expect to 

publish a final rule in 2011. 

• Title II of Public Law 109-451 

authorizes the Secretary of the 

Interior, through the Bureau of 

Reclamation, to issue loan guarantees 

to assist in financing: (a) rural water 

supply projects, (b) extraordinary 

maintenance and rehabilitation of 

Reclamation project facilities, and (c) 

improvements to infrastructure 

directly related to Reclamation 

projects. This new program will 

provide an additional funding option 

to help western communities and 

water managers to cost effectively 

meet their water supply and 

maintenance needs. Under the Act, 

we are working with the Office of 

Management and Budget to publish a 

rule that will establish criteria for 

administering the loan guarantee 

program. We published a proposed 

rule on October 6, 2008, and expect to 

publish a final rule in 2011. 

BILLING CODE 4310–RK–S 


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DEPARTMENT OF JUSTICE (DOJ) 

Statement of Regulatory Priorities 

The Department of Justice’s highest 

priority is to protect America against 

acts of terrorism, both foreign and 

domestic, within the letter and spirit of 

the Constitution. While vigorously 

pursuing the fight against terrorism, the 

Department is also reinvigorating its 

traditional missions by embracing its 

historic role in fighting crime, 

protecting civil rights, preserving the 

environment, and ensuring fairness in 

the market place. The Department is 

working to achieve the fair and 

impartial administration of justice for 

all Americans, to assist its State and 

local partners, and to defend the 

Nation’s interests according to the law. 

In addition to using investigative, 

prosecutorial, and other law 

enforcement activities, the Department 

is also using the regulatory process to 

better carry out the Department’s wideranging law enforcement missions. 

The Department of Justice’s key 

regulatory priorities include regulatory 

initiatives in the area of civil rights, 

criminal justice, and immigration. These 

are summarized below. However, in 

addition to these initiatives, several 

other components of the Department 

carry out important responsibilities 

through the regulatory process. 

Although their regulatory efforts are not 

separately discussed in this overview of 

the regulatory priorities, those 

components have key roles in 

implementing the Department’s antiterrorism and law enforcement 

priorities. 

Civil Rights 

In September 2010, the Department 

published its final rules amending its 

regulations implementing title II of the 

Americans with Disabilities Act (ADA), 

which prohibits discrimination by 

public entities, and title III of the ADA, 

which prohibits discrimination by 

public accommodations and certain 

testing entities and requires commercial 

facilities to be constructed or altered in 

compliance with the ADA accessibility 

standards. These key regulations adopt 

revised ADA Standards for Accessible 

Design and address certain key policy 

issues. During the course of this 

rulemaking project, the Department 

became aware of the need to provide 

guidance on four additional subject 

matter areas—use of accessible web 

sites, movie captions and video 

descriptions, the accessibility of 

emergency call centers (Next Generation 

9-1-1), and accessible equipment and 

furniture. On July 26, 2010, the 

Department published an advance 

notice of proposed rulemaking 

(ANPRM) for each of these subject areas. 

These rules will be the focus of the Civil 

Rights Division’s regulatory activities 

for FY 2011. The Department also plans 

to propose amendments to its ADA 

regulations to implement the ADA 

Amendments Act of 2008, which took 

effect on January 1, 2009. 

The four ANPRMs published on July 

26, 2010, include: 

NG 9-1-1. This ANPRM seeks 

information on possible revisions to the 

Department’s regulation to ensure direct 

access to NG 9-1-1 services for 

individuals with disabilities. In 1991, 

the Department of Justice published a 

regulation to implement title II of the 

Americans with Disabilities Act of 1990 

(ADA). That regulation requires public 

safety answering points (PSAPs) to 

provide direct access to persons with 

disabilities who use analog 

telecommunication devices for the deaf 

(TTYs) 28 CFR 35.162. Since that rule 

was published, there have been major 

changes in the types of communications 

technology used by the general public 

and by people who have disabilities that 

affect their hearing or speech. Many 

individuals with disabilities now use 

the Internet and wireless text devices as 

their primary modes of 

telecommunications. At the same time, 

PSAPs are planning to shift from analog 

telecommunications technology to new 

Internet-Protocol (IP)-enabled Next 

Generation 9-1-1 services (NG 9-1-1) 

that will provide voice and data (such 

as text, pictures, and video) capabilities. 

As PSAPs transition from the analog 

systems to the new technologies, it is 

essential that their plans ensure that 

people with communication disabilities 

will be able to use the new systems. 

Therefore, the Department published 

this ANPRM to begin to develop 

appropriate guidance for PSAPs that are 

making this transition. 

Movie captioning and video 

description. Title III of the ADA requires 

public accommodations to take ‘‘such 

steps as may be necessary to ensure that 

no individual with a disability is treated 

differently because of the absence of 

auxiliary aids and services, unless the 

covered entity can demonstrate that 

taking such steps would cause a 

fundamental alteration or would result 

in an undue burden.’’ 42 U.S.C. section 

12182(b)(2)(A)(iii). Both open and 

closed captioning and audio recordings 

are examples of auxiliary aids and 

services that should be provided by 

places of public accommodations, 28 

CFR section 36.303(b)(1)-(2). The 

Department stated in the preamble to its 

1991 rule that ‘‘[m]ovie theaters are not 

required * * * to present open-captioned 

films,’’ 28 CFR part 36, app. B, but it 

was silent regarding closed captioning 

and video description in movie theaters. 

Since 1991, there have been many 

technological advances in the area of 

closed captioning and video description 

for first-run movies. In June 2008, the 

Department issued a Notice of Proposed 

Rulemaking (NPRM) to revise the ADA 

title III regulation, 73 FR 34466, in 

which the Department stated that it was 

considering options for requiring that 

movie theater owners or operators 

exhibit movies that are captioned or that 

provide video (narrative) description. 

The Department received numerous 

comments urging the Department to 

issue captioning and video description 

regulations. The Department is 

persuaded that such regulations are 

appropriate. However, the Department 

decided to issue an ANPRM to obtain 

more information regarding issues 

raised by commenters; to seek comment 

on technical questions that arose from 

the Department’s research; and to learn 

more about the status of digital 

conversion. In addition, the Department 

sought information regarding whether 

other technologies or areas of interest 

(e.g., 3D) have developed or are in the 

process of development that either 

would replace or augment digital 

cinema or make any regulatory 

requirements for captioning and video 

description more difficult or expensive 

to implement. Responses to these 

questions will inform the Department’s 

decisions about the scope of a proposed 

rule. 

Web Site Accessibility. The Internet as 

it is known today did not exist when 

Congress enacted the ADA, yet today 

the World Wide Web plays a critical 

role in the daily personal, professional, 

civic, and business life of Americans. 

The ADA’s expansive 

nondiscrimination mandate reaches 

goods and services provided by public 

accommodations and public entities 

using Internet websites. Being unable to 

access websites puts individuals at a 

great disadvantage in today’s society, 

which is driven by a dynamic electronic 

marketplace and unprecedented access 

to information. On the economic front, 

electronic commerce, or ‘‘e-commerce,’’ 

often offers consumers a wider selection 

and lower prices than traditional, 

‘‘brick-and-mortar’’ storefronts, with the 

added convenience of not having to 

leave one’s home to obtain goods and 

services. For individuals with 


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disabilities who experience barriers to 

their ability to travel or to leave their 

homes, the Internet may be their only 

way to access certain goods and 

services. Beyond goods and services, 

information available on the Internet 

has become a gateway to education, 

socializing, and entertainment. 

The Internet is also dramatically 

changing the way that governmental 

entities serve the public. Public entities 

are increasingly providing their 

constituents access to government 

services and programs through their 

websites. Through government websites, 

the public can obtain information or 

correspond with local officials without 

having to wait in line or be placed on 

hold. They can also pay fines, apply for 

benefits, renew State-issued 

identification, register to vote, file taxes, 

request copies of vital records, and 

complete numerous other everyday 

tasks. The availability of these services 

and information online not only makes 

life easier for the public, but also 

enables governmental entities to operate 

more efficiently and at a lower cost. 

The ADA’s promise to provide an 

equal opportunity for individuals with 

disabilities to participate in and benefit 

from all aspects of American civic and 

economic life will be achieved in 

today’s technologically advanced 

society only if it is clear to State and 

local governments, businesses, 

educators, and other public 

accommodations that their websites 

must be accessible. Consequently, the 

Department is considering amending its 

regulations implementing title II and 

title III of the ADA to require public 

entities and public accommodations 

that provide products or services to the 

public through Internet websites make 

their sites accessible to and usable by 

individuals with disabilities. 

Equipment and Furniture. Both title II 

and title III of the ADA require covered 

entities to make reasonable 

modifications in their programs or 

services to facilitate participation by 

persons with disabilities. In addition, 

covered entities are required to ensure 

that people are not excluded from 

participation because facilities are 

inaccessible or because the entity has 

failed to provide auxiliary aids. The use 

of accessible equipment and furniture is 

often critical to an entity’s ability to 

provide a person with a disability equal 

access to its services. Changes in 

technology have resulted in the 

development and improved availability 

of accessible equipment and furniture 

that benefit individuals with 

disabilities. Consequently, it is easier 

now to specify appropriate accessibility 

standards for such equipment and 

furniture, as the 2010 ADA Standards 

will do for several types of fixed 

equipment and furniture, including 

ATMs, washing machines, dryers, 

tables, benches, and vending machines. 

To the extent that ADA standards apply 

requirements for fixed equipment and 

furniture, the Department will look to 

those standards for guidance on 

accessibility standards for equipment 

and furniture that are not fixed. The 

ANPRM seeks information about other 

categories of equipment—particularly 

medical equipment and exercise 

equipment. The public is invited to 

suggest other types of equipment that 

should be addressed. 

Prison Rape Elimination 

Pursuant to the Prison Rape 

Elimination Act of 2003 (PREA or the 

‘‘Act’’), the Department is drafting 

regulations to adopt national standards 

for the detection, reduction, and 

punishment of prison rape. PREA 

established the National Prison Rape 

Elimination Commission for the 

purpose of studying prison rape. The 

Commission issued a report that 

provided recommended national 

standards for reducing prison rape, 

which in turn, are to be reviewed by the 

Justice Department. Specifically, PREA 

mandates that national standards issued 

pursuant to PREA ‘‘shall be based upon 

the independent judgment of the 

Attorney General, after giving due 

consideration to the recommended 

national standards provided by the 

Commission... and being informed by 

such data, opinions, and proposals that 

the Attorney General determines to be 

appropriate to consider.’’ The Act 

further provides that the Department 

‘‘shall not establish a national 

standard... that would impose 

substantial additional costs compared to 

the costs presently expended by 

Federal, State, and local prison 

authorities.’’ 

The Department is reviewing the 

Commission’s recommendations and is 

drafting proposed regulations. In 

addition, the Department is reviewing a 

study by an independent contractor 

commissioned by the Department’s 

Office of Justice Programs to analyze the 

costs of the Commission’s proposed 

recommendations. The Department is 

also reviewing extensive public 

comments on the Commission’s 

proposed recommendations pursuant to 

an ANPRM that the Department issued 

while awaiting the completion of the 

cost analysis. 

Federal Habeas Corpus Review 

Procedures in Capital Cases 

Pursuant to the USA PATRIOT 

Improvement and Reauthorization Act 

of 2005, on December 11, 2008, the 

Department promulgated a final rule to 

implement certification procedures for 

States seeking to qualify for the 

expedited Federal habeas corpus review 

procedures in capital cases under 

chapter 154 of title 28 of the United 

States Code. On February 5, 2009, the 

Department published in the Federal 

Register a notice soliciting further 

public comment on all aspects of the 

December 2008 final rule. As the 

Department reviewed the comments 

submitted in response to the February 

2009 notice, it considered further the 

statutory requirements governing the 

regulatory implementation of the 

chapter 154 certification procedures. 

The Attorney General has determined 

that chapter 154 reasonably could be 

construed to allow the Attorney General 

greater discretion in making 

certification determinations than the 

December 2008 regulations allowed. 

Accordingly, a new rulemaking, and the 

removal of the entire December 2008 

final rule, is warranted in order to 

articulate the standards the Attorney 

General will apply in making chapter 

154 certification decisions and to obtain 

public input concerning the formulation 

of such standards. As the first step of 

this process, the Department published 

a notice in the Federal Register on May 

25, 2010, proposing to remove the 

December 2008 regulations pending the 

completion of a new rulemaking 

process. The May 2010 rule will be 

finalized by a final rule to be published 

in the fall of 2010. The next step in the 

process will be the publication of a new 

proposed rule proposing new chapter 

154 certification standards and seeking 

public input concerning the formulation 

of such standards. 

Criminal Law Enforcement 

For the most 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. For example, the FBI is 

currently updating its National Instant 


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Criminal Background Check System 

regulations to allow criminal justice 

agencies to conduct background checks 

prior to the return of firearms. 

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 arsonfor-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 2011, to seek 

modifications to its regulations 

governing commerce in firearms and 

explosives. 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 

Nov. 25, 2002). 

Electronic Prescriptions for Controlled 

Substances. Combating the proliferation 

of methamphetamine and preventing 

the diversion of prescription drugs for 

illicit purposes are among the Attorney 

General’s top drug enforcement 

priorities. The Drug Enforcement 

Administration (DEA) is responsible for 

enforcing the Controlled Substances Act 

and its implementing regulations to 

prevent the diversion of controlled 

substances, while ensuring adequate 

supplies for legitimate medical, 

scientific, and industrial purposes. 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. 

One of DEA’s key regulatory 

initiatives is its Interim Final Rule with 

Request for Comment ‘‘Electronic 

Prescriptions for Controlled 

Substances’’ [RIN 1117-AA61]. This 

regulation provides practitioners with 

the option of writing prescriptions for 

controlled substances electronically and 

permits pharmacies to receive, dispense, 

and archive electronic prescriptions for 

controlled substances. This regulation 

provides pharmacies, hospitals, and 

practitioners with the ability to use 

modern technology for controlled 

substance prescriptions while 

maintaining the closed system of 

controls on controlled substances. 

Bureau of Prisons Initiatives. 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: 

Streamline regulations, eliminating 

unnecessary language and improving 

readability; improve disciplinary 

procedures through a revision of the 

subpart relating to the disciplinary 

process; reduce the introduction of 

contraband through various means, such 

as clarifying drug and alcohol 

surveillance testing programs; protect 

the public from continuing criminal 

activity committed within prison; and 

enhance the Bureau’s ability to more 

closely monitor the communications of 

high-risk inmates. 

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 

authorization was transferred from the 

Justice Department’s Immigration and 

Naturalization Service (INS) to the 

Department of Homeland Security 

(DHS). However, the 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, and the 

Board has jurisdiction over appeals from 

those decisions, as well as other matters. 

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. 

On June 3, 2009, the Attorney General 

announced his intention to initiate a 

new rulemaking proceeding for 

regulations to govern claims of 

ineffective assistance of counsel in 

immigration proceedings. The 

Department is currently drafting 

regulations to further this goal. The 

Department is also drafting regulations 

pursuant to the William Wilberforce 

Trafficking Victims Protection 

Reauthorization Act of 2008 to take into 

account the specialized needs of 

unaccompanied alien children in 

removal proceedings. 

DOJ—Legal Activities (LA) 

PROPOSED RULE STAGE 

93. NATIONAL STANDARDS TO 

PREVENT, DETECT, AND RESPOND 

TO PRISON RAPE 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Legal Authority: 

5 USC 301; 28 USC 509; 28 USC 510; 

42 USC 15601 

CFR Citation: 

28 CFR 115 

Legal Deadline: 

Final, Statutory, June 23, 2010. 


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Abstract: 

The Department of Justice has under 

review national standards for 

enhancing the prevention, detection, 

and response to sexual abuse in 

confinement settings that were 

prepared by the National Commission 

on Prison Rape Elimination pursuant to 

the Prison Rape Elimination Act of 

2003 (PREA) and recommended by the 

Commission to the Attorney General. 

Through an Advance Notice of 

Proposed Rulemaking (ANPRM), the 

Department received public input on 

the Commission’s proposed national 

standards and information useful to the 

Department in publishing a final rule 

adopting national standards for the 

detection, prevention, reduction and 

punishment of prison rape, as 

mandated by PREA. 

Statement of Need: 

Rape is violent, destructive, and a 

crime—no less so when the victim is 

incarcerated. Tolerance of sexual abuse 

of prisoners in the government’s 

custody is incompatible with American 

values. Congress affirmed the duty to 

protect incarcerated individuals from 

sexual abuse by enacting the Prison 

Rape Elimination Act of 2003 (PREA), 

42 U.S.C. section 15601 et seq. 

Summary of Legal Basis: 

PREA requires the Attorney General to 

promulgate regulations that adopt 

national standards for the detection, 

prevention, and punishment of prison 

rape. PREA established the Commission 

to carry out a comprehensive legal and 

factual study of a penological, physical, 

mental, medical, social, and economic 

impacts of prison rape in the United 

States, and to recommend to the 

Attorney General national standard for 

the detection, prevention, reduction 

and punishment of prison rape. The 

Commission released its recommended 

national standards in a report dated 

June 23, 2009. Pursuant to PREA the 

final rule adopting national standards 

‘‘shall be based upon the independent 

judgment of the Attorney General, after 

giving due consideration to the 

recommended national standards 

provided by the Commission. . .and 

being informed by such data, opinions, 

and proposals that the Attorney General 

determines to be appropriate to 

consider.’’ 42 U.S.C. section 

24607(a)(2). PREA expressly mandates 

that the Department shall not establish 

a national standard ‘‘that would impose 

substantial additional costs compared 

to the costs presently expended by the 

Federal, State, and local prison 

authorities.’’ 42 U.S.C. section 

24607(a)(3). 

Alternatives: 

Given the specific direction of 

Congress, the Department is obligated 

to issue a rule that promulgates 

regulations establishing national 

standards to combat prison rape. As 

discussed in the rule and in the 

Regulatory Impact Analysis (RIA) the 

Department has received input from 

numerous stakeholders concerning the 

development of these regulations and, 

as part of the development process, 

considered a wide range of proposals 

in developing the content of such 

standards. 

Anticipated Cost and Benefits: 

In directing the Attorney General to 

promulgate national standards for 

enhancing the prevention, detection, 

reduction, and punishment of prison 

rape. Congress understood that such 

standards were likely to require federal, 

state, and local agencies (as well as 

private entities) that operate inmate 

confinement facilities to incur costs in 

implementing and complying with 

those standards. Given the statue’s 

aspiration to ‘‘eliminate’’ prison rape in 

the United states, Congress recognized 

that costs would need to be expended. 

Indeed, the statute’s findings (42 U.S.C. 

section 15601) suggest an assessment 

by Congress that the benefits to society 

of eliminating prison rape are likely to 

outweigh any anticipated costs of 

achieving that goal. 

The Department’s full discussion of the 

anticipated costs and benefits of this 

rule is included in the rule’s Initial 

Regulatory Impact Assessment. 

Risks: 

These regulations are intended to carry 

out the intent of Congress to eliminate 

prison rape. The risks from the failure 

to promulgate these regulations are 

primarily that inmates in Federal, State, 

and local facilities would be at higher 

risk of sexual assault than they would 

be if these regulations are promulgated. 

Timetable: 

Action Date FR Cite 

ANPRM 03/10/10 75 FR 11077 

ANPRM Comment 

Period End 

05/10/10 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Agency Contact: 

Robert Hinchman 

Senior Counsel, Office of Legal Policy 

Department of Justice 

Room 4252 

950 Pennsylvania Avenue NW 

Washington, DC 20530 

Phone: 202 514–8059 

Fax: 202 353–2371 

Email: robert.hinchman@usdoj.gov 

RIN: 1105–AB34 

BILLING CODE 4410–BP–S 


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DEPARTMENT OF LABOR (DOL) 

U.S. DEPARTMENT OF LABOR 

Fall 2010 Statement of Regulatory 

Priorities 

Secretary Solis has consistently stated 

that all of the work of the Department 

of Labor is focused on achieving Good 

Jobs for Everyone. The Labor 

Department’s vision of a ‘‘good job’’ 

includes jobs that: 

• increase workers’ incomes and 

narrow wage and income inequality; 

• assure workers are paid their wages 

and overtime; 

• increase workers’ incomes and 

narrow wage and income inequality; 

• assure workers are paid their wages 

and overtime; 

• are in safe and healthy workplaces, 

and fair and diverse workplaces; 

• provide workplace flexibility for 

family and personal care-giving; 

• improve health benefits and 

retirement security for all workers; and 

• assure workers have a voice in the 

workplace. 

To achieve this goal, the Department 

is using every tool in its toolbox, 

including increased enforcement 

actions, increased education and 

outreach, and targeted regulatory 

actions. Because the Department cannot 

be in every workplace every day, our 

targeted regulatory actions are centered 

on two broad themes— 

Plan/Prevent/Protect, and Openness and 

Transparency. These unifying themes 

seek to foster a new calculus that 

strengthens protections for workers and 

results in significantly increased 

compliance. Employers and other 

regulated entities must take full 

ownership over their adherence to 

Department regulations. The 

Department also hopes that with greater 

openness and transparency, workers 

will be in a better position to judge 

whether their workplace is one that 

values health and safety, work-life 

balance, and diversity. 

Plan/Prevent/Protect Compliance 

Strategy 

In the fall 2010 regulatory agenda, the 

Occupational Safety and Health 

Administration (OSHA), Mine Safety 

and Health Administration (MSHA), 

Office of Federal Contract Compliance 

Programs (OFCCP), and the Wage and 

Hour Division (WHD) will all propose 

regulatory actions that would require 

employers to develop programs to 

address specific compliance issues 

within each agency’s portfolio. 

Although the specifics will vary by law, 

industry, and regulated enterprise, the 

Plan/Prevent/Protect strategy seeks to 

remind employers and other regulated 

entities that they are responsible for full 

compliance with the law every day, not 

just when Department inspectors come 

calling. As announced with the spring 

2010 regulatory agenda, the strategy will 

require employers and other regulated 

entities to: 

• ‘‘Plan’’: Create a plan for identifying 

and remediating risks of legal violations 

and other risks to workers—for example, 

a plan to inspect their workplaces for 

safety hazards that might injure or kill 

workers. Workers will be given 

opportunities to participate in the 

creation of the plans. In addition, the 

plans would be made available to 

workers so they can fully understand 

them and help to monitor their 

implementation. 

• ‘‘Prevent’’: Thoroughly and 

completely implement the plan in a 

manner that prevents legal violations. 

The plan cannot be a mere paper 

process. This will not be an exercise in 

drafting a plan only to put it on a shelf. 

The plan must be fully implemented. 

• ‘‘Protect’’: Verify on a regular basis 

that the plan’s objectives are being met. 

The plan must actually protect workers 

from health and safety risks and other 

violations of their workplace rights. 

Employers and other regulated 

entities who fail to take these steps to 

comprehensively address the risks, 

hazards, and inequities in their 

workplaces will be considered out of 

compliance with the law and, 

depending upon the agency and the 

substantive law it is enforcing, subject 

to remedial action. But employers, 

unions, and others who follow the 

Department’s Plan/Prevent/Protect 

strategy will assure compliance with 

employment laws before Labor 

Department enforcement personnel 

arrive at their doorsteps. Most 

important, they will assure that workers 

get the safe, healthy, diverse, familyfriendly, and fair workplaces they 

deserve. 

Openness and Transparency: Tools for 

Achieving Compliance 

Greater openness and transparency 

continues to be central to the 

Department’s compliance and regulatory 

strategies. The fall 2010 regulatory plan 

demonstrates the Department’s 

continued commitment to conducting 

the people’s business with openness 

and transparency, not only as good 

government and stakeholder 

engagement strategies, but as important 

means to achieve compliance with the 

employment laws administered and 

enforced by the Department. Openness 

and transparency will not only enhance 

agencies’ enforcement actions but will 

encourage greater levels of compliance 

by the regulated community and 

enhance awareness among workers of 

their rights and benefits. When 

employers, unions, workers, advocates, 

and members of the public have greater 

access to information concerning 

workplace conditions and expectations, 

then we all become partners in the 

endeavor to create Good Jobs for 

Everyone. 

Worker Protection Responsiveness 

The Department believes 

Plan/Prevent/Protect and increased 

Openness and Transparency will result 

in gradual improvements to worker 

health and safety. However, when the 

Department identifies specific hazards 

and risks to worker health, safety, 

security or fairness, we will utilize our 

regulatory powers to limit the risk to 

workers. The fall 2010 regulatory plan 

includes examples of such regulatory 

initiatives to address such specific 

concerns. 

MSHA is planning several regulatory 

initiatives to respond to specific health 

and safety needs of workers: (1) MSHA 

plans to issue an emergency temporary 

standard (ETS) covering the 

Maintenance of Incombustible Content 

of Rock Dust in Underground Coal 

Mines, (2) MSHA advanced the 

publication date for the proposed rule 

covering Examinations of Work Areas in 

Underground Coal Mines from March 

2011 to October 2010, and (3) MSHA 

decided not to publish a request for 

information on Safety and Health 

Management Programs for Mines and is 

instead planning to hold a series of 

public meetings in October 2010 

followed by the publication of a 

proposed rule in June 2011. 

OSHA plans to issue a proposed rule 

that will update fatality and catastrophe 

reporting requirements so the Agency 

receives more timely information on a 

broader range of catastrophic events, 

which will help OSHA conduct more 

responsive investigations. 

Crystalline silica exposure is one of 

the most serious hazards workers face. 

OSHA and MSHA are both proposing to 

address worker exposures to crystalline 

silica through the promulgation and 

enforcement of a comprehensive health 

standard. 


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Occupational Safety and Health 

Administration (OSHA) 

OSHA’s regulatory program is 

designed to help workers and employers 

identify hazards in the workplace, 

prevent the occurrence of injuries and 

adverse health effects, and communicate 

with the regulated community regarding 

hazards and how to effectively control 

them. Long-recognized health hazards 

such as silica, beryllium, and emerging 

hazards such as food flavorings 

containing diacetyl place American 

workers at risk of serious disease and 

death and are initiatives on OSHA’s 

regulatory agenda. In addition to 

targeting specific hazards, OSHA is 

focusing on systematic processes that 

will modernize the culture of safety in 

America’s workplaces. 

Plan/Prevent/Protect 

Infectious Diseases 

OSHA is considering the need for 

regulatory action to address the risk to 

workers exposed to infectious diseases 

in healthcare and other related high-risk 

environments. The Agency is 

considering an approach that would 

combine elements of the Department’s 

Plan/Prevent/Protect strategy with 

established infection control practices. 

The Agency received strong stakeholder 

participation in response to its May 

2010 request for information on 

infectious diseases and is currently 

reviewing the docket. 

In 2007, the healthcare and social 

assistance sector as a whole had 16.5 

million employees. Healthcare 

workplaces can range from small, 

private practices of physicians to 

hospitals that employ thousands of 

workers. In addition, healthcare is 

increasingly being provided in other 

settings such as nursing homes, freestanding surgical and outpatient centers, 

emergency care clinics, patients’ homes, 

and pre-hospitalization emergency care 

settings. OSHA is interested in all routes 

of infectious disease transmission in 

healthcare settings not already covered 

by its bloodborne pathogens standard 

(e.g., contact, droplet, and airborne). 

The Agency is particularly concerned by 

studies that indicate that transmission 

of infectious diseases to both patients 

and healthcare workers may be 

occurring as a result of incomplete 

adherence to recognized, but voluntary, 

infection control measures. Another 

concern is the movement of healthcare 

delivery from the traditional hospital 

setting, with its greater infrastructure 

and resources to effectively implement 

infection control measures, into more 

diverse and smaller workplace setting 

with less infrastructure and fewer 

resources, but with an expanding 

worker population. 

Injury and illness Prevention Program 

(12P2) 

OSHA’s I2P2 program is the prototype 

for the Department’s 

Plan/Prevent/Protect strategy. OSHA’s 

first step in this important rulemaking 

was to hold stakeholder meetings. 

Stakeholder meetings were held in East 

Brunswick, NJ; Dallas, Texas; 

Washington, DC; and Sacramento, 

California, beginning in June 2010 and 

ending in August 2010. More than 200 

stakeholders participated in these 

meetings, and in addition, nearly 300 

stakeholders attended as observers. The 

proposed rule will explore requiring 

employers to provide their employees 

with opportunities to participate in the 

development and implementation of an 

injury and illness prevention program, 

including a systematic process to 

proactively and continuously address 

workplace safety and health hazards. 

This rule will involve planning, 

implementing, evaluating, and 

improving processes and activities that 

promote worker safety and health, and 

address the needs of special categories 

of workers (such as youth, aging, and 

immigrant workers). OSHA’s efforts to 

protect workers under the age of 18 will 

be undertaken in cooperation with the 

Department’s Wage and Hour Division, 

which has responsibility for enforcing 

the child labor provisions of the Fair 

Labor Standards Act. OSHA has 

substantial evidence showing that 

employers that have implemented 

similar injury and illness prevention 

programs have significantly reduced 

injuries and illnesses in their 

workplaces. The new rule would build 

on OSHA’s existing Safety and Health 

Program Management Guidelines and 

lessons learned from successful 

approaches and best practices that have 

been applied by companies 

participating in OSHA’s Voluntary 

Protection Program and Safety and 

Health Achievement Recognition 

Program, and similar industry and 

international initiatives. 

Addressing Targeted Hazards 

Silica 

In order to target one of the most 

serious hazards workers face, OSHA is 

proposing to address worker exposures 

to crystalline silica through the 

promulgation and enforcement of a 

comprehensive health standard. 

Exposure to silica causes silicosis, a 

debilitating respiratory disease, and may 

cause cancer, other chronic respiratory 

diseases, and renal and autoimmune 

disease as well. Over 2 million workers 

are exposed to crystalline silica in 

general industry, construction, and 

maritime industries and workers are 

often exposed to levels that exceed 

current OSHA permissible limits, 

especially in the construction industry 

where workers are exposed at levels that 

exceed current limits by several fold. It 

has been estimated that between 3,500 

and 7,000 new cases of silicosis arise 

each year in the U.S., and that 1,746 

workers died of silicosis between 1996 

and 2005. Reducing these hazardous 

exposures through promulgation and 

enforcement of a comprehensive health 

standard will contribute to OSHA’s goal 

of reducing occupational fatalities and 

illnesses. As a part of the Secretary’s 

strategy for securing safe and healthy 

workplaces, MSHA will also utilize 

information provided by OSHA to 

undertake regulatory action related to 

silica exposure in mines. 

Backing Operations 

In order to target one of most serious 

hazards that construction workers face, 

OSHA is proposing to address worker 

exposures to the dangers inherent in 

backing operations through the 

promulgation and enforcement of a 

revised construction standard. NIOSH 

reports that half of the fatalities 

involving construction equipment occur 

while the equipment is backing. Backing 

accidents cause 500 deaths and 15,000 

injuries per year. Emerging technologies 

in the field of backing operations 

include after market devices, such as 

camera, radar, and sonar, to help 

monitor the presence of workers on foot 

in blind areas, and new monitoring 

technology, such as tag-based warning 

systems that use radio frequency (RFID) 

and magnetic field generators on 

equipment to detect electronic tags 

worn by workers. OSHA is developing 

this proposal in consultation with 

MSHA, which will issue an Emergency 

Temporary Standard concerning 

Proximity Detection. 

Openness and Transparency 

Hazard Communication 

Hearings on OSHA’s proposal to 

modify its Hazard Communication 

standard have helped the agency to 

promote transparency in the 

communication of chemical hazard 

information. These hearings gathered 

information to assist OSHA in creating 

consistency between its current Hazard 

Communication standard (HCS) and the 

United Nations’ Globally Harmonized 

System of Classification and Labeling of 

Chemicals (GHS). This rulemaking 


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involves changing the criteria for 

classifying health and physical hazards 

to require information regarding the 

severity of the hazard, a standardized 

order of information for safety data 

sheets, and adopting standardized 

labeling requirements that would be 

understandable for low-literacy workers 

or those who do not speak English. The 

HCS covers over 945,000 hazardous 

chemical products in 7 million 

American workplaces and gives workers 

the ‘‘right to know’’ about chemical 

hazards to which they are exposed. 

OSHA and other Federal agencies have 

participated in long-term international 

negotiations to develop the GHS. 

Revising the HCS to be consistent with 

the GHS is expected to significantly 

improve the communication of hazards 

to workers in American workplaces, 

reducing exposures to hazardous 

chemicals, and reducing occupational 

illnesses and fatalities. 

Modernizing Recordkeeping 

In the first half of this year, OSHA 

held informal meetings to gather 

information from experts and 

stakeholders regarding the modification 

of its current injury and illness data 

collection system that will help the 

agency, employers, employees, 

researchers, and the public prevent 

workplace injuries and illnesses, as well 

as support President Obama’s Open 

Government Initiative. Under the 

proposed rule, OSFIA will explore 

increasing its legal authority to require 

employers to electronically submit to 

the Agency any data required by part 

1904 (Recording and Reporting 

Occupational Injuries). In addition it 

will set ongoing electronic submission 

requirements of data for a defined set of 

establishments. This two-part rule will 

give OSHA the flexibility to define the 

scope and frequency of data collection 

without having to undertake additional 

rulemakings. With OMB approval, 

OSHA will be able to conduct data 

collections ranging from the annual 

collection of data from a handful of 

employers to the real-time collection of 

all part 1904 data from all covered 

employers. In addition, OSHA will be 

able to request additional data elements 

that employers are not required to 

maintain, such as data on race and 

ethnicity, as a non-mandatory 

component of a given data collection. 

OSHA learned from stakeholders that 

most large employers already maintain 

their part 1904 data electronically; as a 

result, electronic submission will 

constitute a minimal burden on these 

employers, while providing a wealth of 

data to help OSHA, employers, 

employees, researchers, and the public 

prevent workplace injuries and 

illnesses. 

Mine Safety and Health Administration 

(MSHA) 

The Mine Safety and Health 

Administration is the worker protection 

agency focused on the prevention of 

death, disease, and injury from mining 

and the promotion of safe and healthful 

workplaces for the Nation’s miners. The 

Department believes that every worker 

has a right to a safe and healthy 

workplace. Workers should never have 

to sacrifice their lives for their 

livelihood, and all workers deserve to 

come home to their families at the end 

of their shift safe and whole. MSHA’s 

approach to reducing workplace 

fatalities and injuries includes 

promulgating and enforcing mandatory 

health and safety standards. 

Plan/Prevent/Protect 

Safety and Health Management 

Programs for Mines 

Year after year, many mines 

experience low injury and illness rates 

and low violation rates. For these mine 

operators, preventing harm to their 

miners is more than compliance with 

safety and health requirements; it 

reflects the embodiment of a culture of 

safety—from the CEO to the miner. This 

culture of safety derives from a 

commitment to an effective, 

comprehensive safety and health 

management program. Since compliance 

with safety and health standards is the 

responsibility of mine operators, MSHA 

plans to publish a proposed rule to 

require mine operators to develop 

comprehensive Safety and Health 

Management Programs for Mines. 

MSHA believes that operators with 

effective safety and health management 

programs would identify and correct 

hazards in a more timely manner, 

resulting in fewer accidents, injuries 

and illnesses. To help develop the 

proposal, MSHA held public meetings 

and gathered information from worker 

organizations, industry, academia, 

government, and safety and health 

professionals about model safety and 

health programs. 

Examinations of Work Areas in 

Underground Coal Mines for Violations 

of Mandatory Health or Safety 

Standards 

To complement the safety and health 

management programs proposed rule, 

MSHA also plans to issue a proposed 

rule to address section 303(d) of the 

Federal Mine Safety and Health Act that 

requires mine operators to conduct 

examinations, in areas where miners 

work or travel, for violations of 

mandatory health or safety standards. 

The proposal would assure that 

underground coal mine operators find 

and fix violations of mandatory health 

or safety standards, thereby improving 

health and safety for miners. 

Pattern of Violations 

MSHA has determined that the 

existing pattern criteria and procedures 

contained in 30 CFR part 104 do not 

reflect the statutory intent for section 

104(e) of the Federal Mine Safety and 

Health Act of 1977 (Mine Act). The 

legislative history of the Mine Act 

explains that Congress intended the 

pattern of violations to be an 

enforcement tool for operators who have 

demonstrated a disregard for the health 

and safety of miners. These mine 

operators, who have a chronic history of 

persistent significant and substantial 

(S&S) violations, needlessly expose 

miners to the same hazards again and 

again. This indicates a serious safety 

and health management problem at a 

mine. The goal of the pattern of 

violations proposed rule is to compel 

operators to manage health and safety 

conditions so that the root causes of S&S 

violations are found and fixed before 

they become a hazard to miners. The 

proposal would reflect statutory intent, 

simplify the pattern of violations 

criteria, and improve consistency in 

applying the pattern of violations 

criteria. 

Addressing Targeted Hazards 

Maintenance of Incombustible Content 

of Rock Dust in Underground Coal 

Mines 

To help prevent explosion hazards, 

MSHA issued an emergency temporary 

standard (ETS) in response to the grave 

danger that miners in underground 

bituminous coal mines face when 

accumulations of coal dust are not made 

inert. MSHA concluded from 

investigations of mine explosions and 

other reports that immediate action was 

necessary to protect miners. 

Accumulations of coal dust can ignite, 

resulting in an explosion, or after an 

explosion, accumulations can 

propagate, increasing the severity of 

explosions. The ETS requires mine 

operators to increase the incombustible 

content of combined coal dust, rock 

dust, and other dust to at least 80 

percent in underground bituminous coal 

mines. The ETS strengthens the 

protections for miners by reducing both 

the potential for and the severity of coal 

mine explosions. 

Regulating Crystalline Silica Exposure 


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The Agency’s regulatory actions also 

exemplify a commitment to protecting 

the most vulnerable populations while 

assuring broad-based compliance. 

Health hazards are pervasive in both 

coal and metal/nonmetal mines 

(including surface and underground 

mines) and large and small mines. As 

mentioned previously, as part of the 

Secretary’s strategy for securing safe and 

healthy workplaces, both MSHA and 

OSHA will be undertaking regulatory 

actions related to silica. Overexposure 

to crystalline silica can result in some 

miners developing silicosis, an 

irreversible but preventable lung 

disease, which ultimately may be fatal. 

In its proposed rule, MSHA plans to 

follow the recommendation of the 

Secretary of Labor’s Advisory 

Committee on the Elimination of 

Pneumoconiosis Among Coal Mine 

Workers, National Institute for 

Occupational Safety and Health 

(NIOSH), and other groups to address 

the exposure limit for respirable 

crystalline silica. As another example of 

intra-departmental collaboration, MSHA 

intends to consider OSHA’s work on the 

health effects of occupational exposure 

to silica and OSHA’s risk assessment in 

developing the appropriate standard for 

the mining industry. 

Lowering Miners’ Exposure to Coal 

Mine Dust, including Continuous 

Personal Dust Monitors 

MSHA will continue its regulatory 

action related to preventing Black Lung 

disease. Data from the NIOSH indicate 

increased prevalence of coal workers 

pneumoconiosis (CWP) ‘‘clusters’’ in 

several geographical areas, particularly 

in the Southern Appalachian Region. 

MSHA published a notice of proposed 

rulemaking to address continued risk to 

coal miners from exposure to respirable 

coal mine dust. This regulatory action is 

part of MSHA’s Comprehensive Black 

Lung Reduction Strategy for reducing 

miners’ exposure to respirable dust. 

This strategy includes enhanced 

enforcement, education and training, 

and health outreach and collaboration. 

The major provisions of the proposal 

would lower the existing exposure limit 

from 2.0 mg/m3 to 1.0 mg/m3 over a 2- 

year phase-in period, provide for single 

full-shift compliance sampling under 

both mine operator and MSHA 

inspector sampling programs, and 

establish sampling requirements for use 

of the continuous personal dust 

monitors. 

Proximity Detection Systems 

MSHA will issue an emergency 

temporary standard (ETS) to address the 

grave danger that miners face when 

working near mobile equipment in 

underground mines. MSHA has 

concluded, from investigations of 

accidents involving mobile equipment 

and other reports, that immediate action 

is necessary to protect miners. To date, 

in 2010, there have been 5 fatalities 

resulting from crushing and pinning 

accidents. Mobile equipment can pin, 

crush, or strike a miner working near 

the equipment. Proximity detection 

technology can prevent these types of 

accidents. Proximity detection systems 

can be installed on mining machinery to 

detect the presence of personnel or 

equipment within a certain distance of 

the machine. The ETS would strengthen 

the protection for underground miners 

by reducing the potential of pinning, 

crushing or striking hazards associated 

with working close to mobile 

equipment. As a part of the Secretary’s 

strategy for securing safe and healthy 

workplaces, OSHA will also undertake 

regulatory action related to reducing 

injuries and fatalities to workers in close 

proximity to moving equipment and 

vehicles. 

Wage and Hour Division (WHD) 

The Wage and Hour Division is 

responsible for administering and 

enforcing a number of laws that 

establish the minimum standards for 

wages and working conditions in the 

United States. Collectively, these labor 

standards cover most private, state, and 

local government employment. 

Plan/Prevent/Protect 

Right To Know Under the Fair Labor 

Standards Act 

WHD intends to publish a proposed 

rule updating the recordkeeping 

regulation issued under the Fair Labor 

Standards Act (FLSA) to assist 

employers in planning to protect 

workers’ entitlement to wages that they 

have earned and bring greater 

transparency and openness to the 

workplace. The proposed rule would 

address notification of workers’ status as 

employees or some other status such as 

independent contractors, and whether 

that worker is entitled to the protections 

of the FLSA. The proposed rulemaking 

would also explore requiring employers 

to provide a wage statement each pay 

period to their employees. This greater 

transparency will provide workers with 

essential information about their 

employment status and earnings, 

consistent with the Secretary’s strategic 

vision. This greater transparency will in 

turn better ensure compliance by 

regulated entities and assist the 

Department with its enforcement efforts. 

This initiative contributes to the 

Department’s efforts to prevent 

misclassification that denies workers 

employment law protections to which 

they are entitled. 

As part of this Departmentwide 

initiative, OSHA’s Injury and Illness 

Prevention Program NPRM and 

OFCCP’s NPRM on Construction 

Contractor Affirmative Action 

Requirements, propose to also address 

employer analyses and worker 

notification as to whether an individual 

is an employee or is an independent 

business, volunteer, or trainee. 

Office of Federal Contract Compliance 

Programs (OFCCP) 

Through the work of the Office of 

Federal Contract Compliance Programs, 

DOL ensures that the contractors and 

sub-contractors doing business at over 

200,000 establishments provide equal 

employment opportunities—a fair and 

diverse workplace. OFCCP ensures 

workers are recruited, hired, trained, 

promoted, terminated, and compensated 

in a non-discriminatory manner by 

Federal contractors and helps workers 

in the Federal contractor sector by 

strengthening affirmative action and by 

combating discrimination on the basis 

of race, color, religion, sex, national 

origin, disability, or status as a protected 

veteran. 

Construction Contractor Affirmative 

Action Requirements 

OFCCP will publish a proposed rule 

that would enhance the effectiveness of 

the affirmative action program 

requirements for Federal and federally 

assisted construction contractors and 

subcontractors. The proposed rule 

would strengthen the regulations that 

set forth the actions construction 

contractors are required to take to 

implement their affirmative action 

programs particularly in the areas of 

recruitment, training, and 

apprenticeships. OFCCP is coordinating 

with the Employment and Training 

Administration (ETA), which is 

developing a proposed regulation 

revising the equal opportunity 

regulatory framework under the 

National Apprenticeship Act. 

Employee Benefits Security 

Administration (EBSA) 

The Employee Benefits Security 

Administration (EBSA) is responsible 

for administering and enforcing the 

fiduciary, reporting and disclosure, and 

health coverage provisions of title I of 

the Employee Retirement Income 

Security Act of 1974 (ERISA). This 

includes recent amendments and 

additions to ERISA enacted in the 


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Pension Protection Act of 2006, as well 

as new health coverage provisions 

under the Patient Protection and 

Affordable Care Act of 2010 (the 

Affordable Care Act). EBSA’s regulatory 

plan initiatives are intended to improve 

health benefits and retirement security 

for workers in every type of job at every 

income level. EBSA is charged with 

protecting approximately 150 million 

Americans covered by an estimated 

708,000 private retirement plans, 2.6 

million health plans, and similar 

numbers of other welfare benefit plans 

which together hold $5.2 trillion in 

assets. 

EBSA will continue to issue guidance 

implementing the health reform 

provisions of the Affordable Care Act 

and other laws, such as the Mental 

Health Parity and Addiction Equity Act, 

to help provide better quality health 

care for American workers and their 

families. EBSA’s regulations reduce 

discrimination in health coverage, 

promote better access to quality 

coverage, and protect the ability of 

individuals and businesses to keep their 

current health coverage. Many 

regulations are joint rulemakings with 

the Departments of Health and Human 

Services and the Treasury. 

Using regulatory changes to produce 

greater openness and transparency is an 

integral part of EBSA’s contribution to 

a Departmentwide compliance strategy. 

These efforts will not only enhance 

EBSA’s enforcement toolbox but will 

encourage greater levels of compliance 

by the regulated community and 

enhance awareness among workers of 

their rights and benefits. Several 

proposals from the EBSA agenda 

expand disclosure requirements, 

substantially enhancing the availability 

of information to employee benefit plan 

participants and beneficiaries and 

employers, and strengthening the 

retirement security of America’s 

workers. 

Health Reform Implementation 

These regulations require better 

disclosure to participants and 

beneficiaries regarding their health plan 

coverage. These disclosures must now 

provide new and better descriptions 

regarding: 

Certain enrollment opportunities and 

access to health coverage; rights to 

internal claims and appeals, and 

external review of health plan denials; 

access to providers; and a group health 

plan’s status as a grandfathered health 

plan, which affects consumer 

protections under the Patient Protection 

and Affordable Care Act. 

Enhancing participant protections 

EBSA recently proposed amendments 

to its regulations to clarify the 

circumstances under which a person 

will be considered a ‘‘fiduciary’’ when 

providing investment advice to 

employee benefit plans and their 

participants and beneficiaries of such 

plans. The amendments would take into 

account current practices of investment 

advisers and the expectations of plan 

officials and participants who receive 

investment advice. This initiative is 

intended to assure retirement security 

for workers in all jobs regardless of 

income level by ensuring that financial 

advisers and similar persons are 

required to meet ERISA’s strict 

standards of fiduciary responsibility. 

Lifetime Income Options 

In February 2010, EBSA published a 

request for information concerning steps 

it can take by regulation, or otherwise, 

to encourage the offering of lifetime 

annuities or similar lifetime benefits 

distribution options for participants and 

beneficiaries of defined contribution 

plans. EBSA recently held a hearing 

with the Department of the Treasury 

and Internal Revenue Service to further 

explore these possibilities during the 

fall 2010 regulatory cycle. This initiative 

is intended to assure retirement security 

for workers in all jobs regardless of 

income level by helping to ensure that 

participants and beneficiaries have the 

benefit of their plan savings throughout 

retirement. 

Promoting Openness and Transparency 

In addition to its health care reform 

and participant protection initiatives, 

EBSA is pursuing a regulatory program 

that, as reflected in the Unified Agenda, 

is designed to encourage, foster, and 

promote openness, transparency, and 

communication with respect to the 

management and operations of pension 

plans, as well as participant rights and 

benefits under such plans. Among other 

things, EBSA will be issuing a final rule 

that will ensure that the participants 

and beneficiaries in participant-directed 

individual account plans are provided 

the information they need, including 

information about plan and investmentrelated fees and expenses, to make 

informed decisions about the 

management of their individual 

accounts and the investment of their 

retirement savings (RIN 1210-AB07); 

EBSA also will be issuing a proposed 

rule addressing the requirement that 

administrators of defined benefit 

pension plans annually disclose the 

funding status of their plan to the plan’s 

participants and beneficiaries (RIN l210- 

AB18). EBSA’s Unified Agenda also 

includes the publication of a proposed 

rule requiring the automatic furnishing 

of a statement to pension plan 

participants informing them of their 

accrued and vested pension benefits, as 

well as other information pertinent to 

their retirement security (RIN 1210- 

AB20). In addition, EBSA will be 

amending the disclosure requirements 

applicable to plan investment options, 

including Qualified Default Investment 

Alternatives, to better ensure that 

participants understand the operations 

and risks associated with investments in 

target date funds (RIN 1210-AB38). A 

complete listing of EBSA’s regulatory 

initiatives (both Plan and non-Plan 

items) is provided in the Unified 

Agenda portion of this document. 

Office of Labor-Management Standards 

(OLMS) 

The Office of Labor-Management 

Standards (OLMS) administers and 

enforces most provisions of the LaborManagement Reporting and Disclosure 

Act of 1959 (LMRDA). The LMRDA 

promotes labor-management 

transparency by requiring unions, 

employers, labor-relations consultants, 

and others to file reports that are 

publicly available. The LMRDA 

includes provisions protecting union 

member rights to participate in their 

union’s governance, to run for office and 

fully exercise their union citizenship, as 

well as procedural safeguards to ensure 

free and fair union elections. Besides 

enforcing these provisions, OLMS also 

ensures the financial accountability of 

unions, their officers and employees, 

through enforcement and voluntary 

compliance efforts. Because of these 

activities, OLMS better ensures that 

workers have a more effective voice in 

the governance of their unions, which in 

turn affords them a more effective voice 

in their workplaces. OLMS also 

administers certain provisions of 

Executive Order 13496 that require 

Federal contractors to notify their 

employees concerning their rights under 

Federal labor laws. 

Openness and Transparency 

Persuader Agreements: Employer and 

Labor Consultant Reporting under the 

LMRDA 

OLMS is proposing a regulatory 

initiative to provide workers with 

information critical to their effective 

participation in the workplace, both as 

union members and as employees. 

OLMS intends to propose regulations to 

better implement the public disclosure 

objectives of the LMRDA in situations 

where an employer engages a consultant 


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in order to persuade employees 

concerning their rights to organize and 

bargain collectively. Under LMRDA 

section 203, an employer must report 

any agreement or arrangement with a 

consultant to persuade employees 

concerning their rights to organize and 

collectively bargain, or to obtain certain 

information concerning the activities of 

employees or a labor organization in 

connection with a labor dispute 

involving the employer. The consultant 

is also required to report such an 

agreement or arrangement with an 

employer. Statutory exceptions to these 

reporting requirements are set forth in 

LMRDA section 203(c), which provides, 

in part, that employers and consultants 

are not required to file a report by 

reason of the consultant’s giving or 

agreeing to give ‘‘advice’’ to the 

employer. The Department is 

reconsidering the current policy 

concerning the scope of the ‘‘advice 

exception.’’ When workers have the 

necessary information about 

arrangements that have been made by 

their employer to persuade them 

whether or not to form, join or assist a 

union, they are better able to make a 

more informed choice about 

representation. 

Employment and Training 

Administration (ETA) 

The Employment and Training 

Administration (ETA) administers and 

oversees programs that prepare workers 

for good jobs at good wages by 

providing high quality job training, 

employment, labor market information, 

and income maintenance services 

through its national network of OneStop centers. The programs within ETA 

promote pathways to economic 

independence for individuals and 

families. Through several laws, ETA is 

charged with administering numerous 

employment and training programs 

designed to assist the American worker 

in developing the knowledge, skills, and 

abilities that are sought after in the 21st 

century’s economy. 

Openness and Transparency 

Temporary Non Agricultural 

Employment of H-2B Aliens in the 

United States 

As part of the Department’s labor 

certification responsibilities, ETA 

certifies whether U.S. workers capable 

of performing the jobs for which 

employers are seeking foreign workers 

are available and whether the 

employment of foreign workers will 

adversely affect the wages and working 

conditions of U.S. workers similarly 

employed. Through the Wage and Hour 

Division (WHD), the Department 

enforces compliance with the 

conditions of an H-2B petition and 

Department of Labor-approved 

temporary labor certification. 

The proposed rule seeks to ensure 

that only those employers who 

demonstrate a real temporary need for 

foreign workers will have access to the 

H-2B program. The proposed rule also 

will seek to provide U.S. workers with 

greater access to the jobs employers 

wish to fill with temporary H-2B 

workers through more robust 

recruitment by employers to 

demonstrate the unavailability of U.S. 

workers and through the creation of a 

national, electronic job registry. In 

addition, the Department is reviewing 

the current wage determination 

methodology to ensure that wages are 

not being adversely affected across 

industries and occupations. The 

proposed rule will explore 

strengthening existing worker 

protections, establishing new 

protections, and enhancing ETA 

program integrity measures and WHD 

enforcement to ensure adequate 

protections for both U.S. and H-2B 

workers. The proposal will include 

greater transparency and openness to 

provide U.S. workers with greater 

information and access to the job 

opportunities. 

Addressing Targeted Concerns of 

Workers 

Equal Employment Opportunity in 

Apprenticeship and Training, 

Amendment of Regulations 

The revision of the National 

Apprenticeship Act Equal Opportunity 

in Apprenticeship and Training (EEO) 

regulations is a critical element in the 

Department’s vision to promote and 

expand registered apprenticeship 

opportunities in the 21st Century while 

safeguarding the welfare and safety of 

all apprentices. In October 2008, ETA 

issued a final rule updating 29 CFR part 

29, the regulatory framework for 

registration of apprenticeship programs 

and apprentices, and administration of 

the National Apprenticeship System. 

The companion EEO regulations, 29 

CFR part 30, have not been amended 

since 1978. ETA proposes to update part 

30 EEO in the Apprenticeship and 

Training regulations to ensure that they 

act in concert with the 2008 revised part 

29 rule. The proposed EEO regulations 

also will further Secretary Solis’ vision 

of good jobs for everyone by ensuring 

that apprenticeship program sponsors 

develop and fully implement affirmative 

action efforts that provide equal 

opportunity for all applicants to 

apprenticeship and apprentices, 

regardless of race, gender, national 

origin, or disability. ETA is coordinating 

with OFCCP, which is developing a 

proposed regulation that would enhance 

the effectiveness of the affirmative 

action program requirements for Federal 

and federally assisted construction 

contractors and subcontractors. 

DOL—Office of Federal Contract 

Compliance Programs (OFCCP) 

PROPOSED RULE STAGE 

94. CONSTRUCTION CONTRACTOR 

AFFIRMATIVE ACTION 

REQUIREMENTS 

Priority: 

Other Significant 

Legal Authority: 

sec 201, 202, 205, 211, 301, 302, and 

303 of EO 11246, as amended; 30 FR 

12319; 32 FR 14303, as amended by 

EO 12086 

CFR Citation: 

41 CFR 60–1; 41 CFR 60–4 

Legal Deadline: 

None 

Abstract: 

This Notice of Proposed Rulemaking 

(NPRM) would revise the regulations in 

41 CFR part 60-4 implementing the 

affirmative action requirements of 

Executive Order 11246 that are 

applicable to Federal and federally 

assisted construction contractors. The 

NPRM will strengthen and enhance the 

effectiveness of the affirmative action 

program requirements for Federal and 

federally-assisted construction 

contractors and subcontractors, 

particularly in the area of recruitment 

and job training. 

Statement of Need: 

The regulations implementing 

construction contractor affirmative 

action obligations under Executive 

Order 11246, as amended, were last 

revised in 1980. Recent data show that 

disparities in the representation of 

women and racial minorities continue 

to exist in on-site construction 

occupations in the construction 

industry. The NPRM would remove 

outdated regulatory provisions, propose 

a new method for establishing 

affirmative action goals, and propose 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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other revisions to the affirmative action 

requirements that reflect the realities of 

the labor market and employment 

practices in the construction industry 

today. 

Summary of Legal Basis: 

This action is not required by statute 

or court order. Legal Authority: 

Sections 201, 202, 205, 211, 301, 302, 

and 303 of E.O. 11246, as amended, 

30 FR 12319: 32 FR 14303, as amended 

by E.O. 12086. 

Alternatives: 

Regulatory alternatives will be 

addressed as the NPRM is developed 

Anticipated Cost and Benefits: 

There may be some additional costs to 

contractors as a result of the increased 

scope of required actions. The benefits 

would likely include increased 

diversity in construction workplaces 

and increased opportunities for women 

and minorities to get on-site 

construction jobs. More detailed cost 

and benefit analyses will be made as 

the NPRM is developed. 

Risks: 

Failure to provide updated regulations 

may impede the equal opportunity 

rights of some workers in protected 

classes. 

Timetable: 

Action Date FR Cite 

NPRM 07/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

None 

Federalism: 

Undetermined 

Agency Contact: 

Sandra M. Dillon 

Deputy Director, Division of Policy, 

Planning and Program Development 

Department of Labor 

Office of Federal Contract Compliance 

Programs 

200 Constitution Avenue NW. 

N3422 

Washington, DC 20210 

Phone: 202 693–0102 

TDD Phone: 202 693–1337 

Fax: 202 693–1304 

Email: ofccp-public@dol.gov 

Related RIN: Previously reported as 

1215–AB81 

RIN: 1250–AA01 

DOL—Office of Labor-Management 

Standards (OLMS) 

PROPOSED RULE STAGE 

95. PERSUADER AGREEMENTS: 

EMPLOYER AND LABOR RELATIONS 

CONSULTANT REPORTING UNDER 

THE LMRDA 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Legal Authority: 

29 USC 433; 29 USC 438 

CFR Citation: 

29 CFR 405; 29 CFR 406 

Legal Deadline: 

None 

Abstract: 

The Department intends to publish 

notice and comment rulemaking 

seeking consideration of a revised 

interpretation of section 203(c) of the 

Labor-Management Reporting and 

Disclosure Act (LMRDA). That statutory 

provision creates an ‘‘advice’’ 

exemption from reporting requirements 

that apply to employers and other 

persons in connection with persuading 

employees about the right to organize 

and bargain collectively. A proposed 

revised interpretation would narrow the 

scope of the advice exemption. 

Statement of Need: 

The Department of Labor is proposing 

a regulatory initiative to better 

implement the public disclosure 

objectives of the Labor-Management 

Reporting and Disclosure Act (LMRDA) 

regarding employer-consultant 

agreements to persuade employees 

concerning their rights to organize and 

bargain collectively. Under LMRDA 

section 203, an employer must report 

any agreement or arrangement with a 

third party consultant to persuade 

employees as to their collective 

bargaining rights or to obtain certain 

information concerning the activities of 

employees or a labor organization in 

connection with a labor dispute 

involving the employer. The consultant 

also is required to report concerning 

such an agreement or arrangement with 

an employer. Statutory exceptions to 

these reporting requirements are set 

forth in LMRDA section 203(c), which 

provides, in part, that employers and 

consultants are not required to file a 

report by reason of the consultant’s 

giving or agreeing to give ‘‘advice’’ to 

the employer. The Department believes 

that its current policy concerning the 

scope of the ‘‘advice exception’’ is 

overbroad and that a narrower 

construction would better allow for the 

employer and consultant reporting 

intended by the LMRDA. Regulatory 

action is needed to provide workers 

with information critical to their 

effective participation in the workplace. 

Summary of Legal Basis: 

This proposed rulemaking is authorized 

under U.S.C. sections 433 and 438 and 

applies to regulations at 29 CFR part 

405 and 29 CFR part 406. 

Alternatives: 

Alternatives will be developed and 

considered in the course of notice and 

comment rulemaking. 

Anticipated Cost and Benefits: 

Anticipated costs and benefits of this 

proposed regulatory initiative have not 

been assessed and will be determined 

at a later date, as appropriate. 

Risks: 

This action does not affect public 

health, safety, or the environment. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

URL For More Information: 

www.olms.dol.gov 

URL For Public Comments: 

www.regulations.gov 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79594 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Agency Contact: 

Andrew R. Davis 

Chief, Division of Interpretations and 

Standards, Office of Labor–Management 

Standards 

Department of Labor 

Office of Labor–Management Standards 

Room N–5609, FP Building 

200 Constitution Avenue NW. 

Washington, DC 20210 

Phone: 202 693–1254 

Fax: 202 693–1340 

Email: davis.andrew@dol.gov 

Related RIN: Previously reported as 

1215–AB79 

RIN: 1245–AA03 

DOL—Wage and Hour Division (WHD) 

PROPOSED RULE STAGE 

96. RIGHT TO KNOW UNDER THE 

FAIR LABOR STANDARDS ACT 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Legal Authority: 

29 USC 211(c) 

CFR Citation: 

29 CFR 516 

Legal Deadline: 

None 

Abstract: 

The Department of Labor proposes to 

update the recordkeeping regulations 

under the Fair Labor Standards Act in 

order to enhance the transparency and 

disclosure to workers of their status as 

the employer’s employee or some other 

status, such as an independent 

contractor, and if an employee, how 

their pay is computed. The Department 

also proposes to clarify that the 

mandatory manual preparation of 

‘‘homeworker’’ handbooks applies only 

to employers of employees performing 

homework in the restricted industries. 

The title of this proposed rule has 

changed to better reflect the purpose 

of this action. 

Statement of Need: 

The recordkeeping regulation issued 

under the Fair Labor Standards Act 

(FLSA), 29 CFR part 516, specifies the 

scope and manner of records covered 

employers must keep that demonstrate 

compliance with minimum wage, 

overtime, and child labor requirements 

under the FLSA, or the records to be 

kept that confirm particular exemptions 

from some of the Act’s requirements 

may apply. This proposal intends to 

update the recordkeeping requirements 

to foster more openness and 

transparency in demonstrating 

employers’ compliance with applicable 

requirements to their workers, to better 

ensure compliance by regulated 

entities, and to assist in enforcement. 

In addition, the proposal intends to 

update the requirements for live-in 

domestic employees and, to clarify that 

the mandatory manual preparation of 

‘‘homeworker’’ handbooks applies only 

to employers of employees performing 

homework in the restricted industries. 

Summary of Legal Basis: 

These regulations are authorized by 

section 11 of the Fair Labor Standards 

Act, 29 U.S.C. 211. 

Alternatives: 

Alternatives will be developed in 

considering proposed revisions to the 

current recordkeeping requirements. 

The public will be invited to provide 

comments on the proposed revisions 

and possible alternatives. 

Anticipated Cost and Benefits: 

The Department will prepare estimates 

of the anticipated costs and benefits 

associated with the proposed rule. 

Risks: 

This action does not affect public 

health, safety, or the environment. 

Timetable: 

Action Date FR Cite 

NPRM 04/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Local, State, Tribal 

Federalism: 

Undetermined 

Agency Contact: 

Montaniel Navarro 

Fair Labor Standards Act Branch Chief, 

Division of Enforcement Policy 

Department of Labor 

Wage and Hour Division 

200 Constitution Avenue NW. 

Room S–3502 

FP Building 

Washington, DC 20210 

Phone: 202 693–0067 

Fax: 202 693–1387 

Related RIN: Previously reported as 

1215–AB78 

RIN: 1235–AA04 

DOL—Employment and Training 

Administration (ETA) 

PROPOSED RULE STAGE 

97. LABOR CERTIFICATION PROCESS 

AND ENFORCEMENT FOR 

TEMPORARY EMPLOYMENT IN 

OCCUPATIONS OTHER THAN 

AGRICULTURE OR REGISTERED 

NURSING IN THE UNITED STATES 

(H–2B WORKERS) 

Priority: 

Other Significant 

Legal Authority: 

8 USC 1101(a)(15)(H)(ii)(B)); 8 USC 

1184(c)(1); 8 CFR 214.2(h) 

CFR Citation: 

20 CFR 655 

Legal Deadline: 

None 

Abstract: 

The Department of Homeland Security 

(DHS) regulations require employers to 

apply for a temporary labor certification 

from the Department of Labor before H2B visas may be approved. DOL 

certifies that there are not sufficient 

U.S. worker(s) who are capable of 

performing the temporary services or 

labor at the time of an application for 

a visa, and that the employment of the 

H-2B workers will not adversely affect 

the wages and working conditions of 

similarly employed U.S. workers. This 

regulation proposes to re-engineer the 

H-2B program in order to enhance 

transparency and strengthen program 

integrity and protections of both U.S. 

workers and H-2B workers. 

Statement of Need: 

The Department has determined that a 

new rulemaking effort is necessary for 


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the H-2B program. The policy 

underpinnings of the current 

regulation, e.g., streamlining the H-2B 

process to defer many determinations 

of program compliance until after an 

application has been adjudicated, do 

not provide an adequate level of 

protection for either U.S. or foreign 

workers. The proposed rule seeks to 

enhance worker protections and 

increase the availability of job 

opportunities to qualified U.S. workers. 

Summary of Legal Basis: 

The Department of Labor’s authority to 

revise these regulations derives from 8 

U.S.C. 1101(a)(15)(H)(ii)(B) and 8 U.S.C. 

1184(c)(1) and 8 CFR 214.2(h). 

Alternatives: 

The public will be afforded an 

opportunity to provide comments on 

the proposed regulatory changes when 

the Department publishes the NPRM in 

the Federal Register. A final rule will 

be issued after analysis of, and 

response to, public comments. 

Anticipated Cost and Benefits: 

Preliminary estimates of the anticipated 

costs of this regulatory action are under 

development. The Department of Labor 

is seeking information on potential 

additional or actual costs from 

employers and other interested parties 

through the NPRM in order to better 

assess the costs and benefits of the 

proposed provisions of the program. 

The proposed changes are thought to 

raise ‘‘novel legal or policy issues’’ but 

are not economically significant within 

the context of Executive Order 12866 

and are not a ‘‘major rule’’ under 

section 804 for the Small Business 

Regulatory Enforcement Fairness Act. 

Risks: 

This action does not affect the public 

health, safety, or the environment. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

State 

Agency Contact: 

Dr. William L. Carlson 

Administrator, Office of Foreign Labor 

Certification 

Department of Labor 

Employment and Training Administration 

FP Building 

Room C–4312 

200 Constitution Avenue NW. 

Washington, DC 20210 

Phone: 202 693–3010 

Email: carlson.william@dol.gov 

RIN: 1205–AB58 

DOL—ETA 

98. EQUAL EMPLOYMENT 

OPPORTUNITY IN APPRENTICESHIP 

AND TRAINING, AMENDMENT OF 

REGULATIONS 

Priority: 

Other Significant 

Legal Authority: 

sec 1, 50 Stat 664, as amended (29 USC 

50; 40 USC 276c; 5 USC 301); 

Reorganization Plan No 14 of 1950, 64 

Stat 1267 (5 USC app p 534) 

CFR Citation: 

29 CFR 30 (Revision) 

Legal Deadline: 

None 

Abstract: 

Revisions to the equal opportunity 

regulatory framework for the National 

Apprenticeship Act are a critical 

element in the Department’s vision to 

promote and expand Registered 

Apprenticeship opportunities in the 

21st century while continuing to 

safeguard the welfare and safety of 

apprentices. In October 2008, the 

Agency issued a Final Rule updating 

regulations for Apprenticeship 

Programs and Labor Standards for 

Registration. These regulations, codified 

at title 29 Code of Federal Regulations 

(CFR) part 29, had not been updated 

since 1977. The companion regulations, 

29 CFR part 30, Equal Employment 

Opportunity (EEO) in Apprenticeship 

and Training, have not been amended 

since 1978. 

The Agency now proposes to update 

29 CFR part 30 to ensure that the 

National Registered Apprenticeship 

System is consistent and in alignment 

with EEO law, as it has developed 

since 1978, and recent revisions to title 

29 CFR part 29. This second phase of 

regulatory updates will ensure that 

Registered Apprenticeship is positioned 

to continue to provide economic 

opportunity for millions of Americans 

while keeping pace with these new 

requirements. 

Statement of Need: 

Federal regulations for Equal 

Employment Opportunity (EEO) in 

Apprenticeship and Training have not 

been updated since 1978. Updates to 

these regulations are necessary to 

ensure that DOL regulatory 

requirements governing the National 

Registered Apprenticeship System are 

consistent with the current state of EEO 

law, the ADA, and recent revisions to 

title 29 CFR part 29. 

Summary of Legal Basis: 

These regulations are authorized by the 

National Apprenticeship Act of 1937 

(29 U.S.C. 50) and the Copeland Act 

(40 U.S.C. 276c). These regulations will 

set forth policies and procedures to 

promote equality of opportunity in 

apprenticeship programs registered 

with the U.S. Department of Labor or 

in State Apprenticeship Agencies 

recognized by the U.S. Department of 

Labor. 

Alternatives: 

The public will be afforded an 

opportunity to provide comments on 

the proposed amendment to 

Apprenticeship EEO regulations when 

the Department publishes a Notice of 

Proposed Rulemaking (NPRM) in the 

Federal Register. A Final Rule will be 

issued after analysis and incorporation 

of public comments to the NRPM. 

Anticipated Cost and Benefits: 

The proposed changes are thought to 

raise ‘‘novel legal or policy issue’’ but 

are not economically significant within 

the context of Executive Order 12866 

and are not a ‘‘major rule’’ under 

Section 804 of the Small Business 

Regulatory Enforcement Fairness Act. 

Risks: 

This action does not affect the public 

health, safety, or the environment. 

Timetable: 

Action Date FR Cite 

NPRM 07/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal, State, Tribal 


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Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Agency Contact: 

John V. Ladd 

Office of Apprenticeship 

Department of Labor 

Employment and Training Administration 

200 Constitution Avenue NW. 

Room N5311 

FP Building 

Washington, DC 20210 

Phone: 202 693–2796 

Fax: 202 693–3799 

Email: ladd.john@dol.gov 

RIN: 1205–AB59 

DOL—Employee Benefits Security 

Administration (EBSA) 

PRERULE STAGE 

99. LIFETIME INCOME OPTIONS FOR 

PARTICIPANTS AND BENEFICIARIES 

IN RETIREMENT PLANS 

Priority: 

Other Significant 

Legal Authority: 

29 USC 1135; ERISA sec 505 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

This initiative will explore what steps, 

if any, that the Department could or 

should take, by regulation or otherwise, 

to enhance the retirement security of 

American workers by facilitating access 

to and use of lifetime income or income 

arrangements designed to provide a 

stream of income after retirement. 

Statement of Need: 

With a continuing trend away from 

defined benefit plans to defined 

contribution plans, employees are not 

only increasingly responsible for the 

adequacy of their retirement savings, 

but also for ensuring that their savings 

last throughout their retirement. 

Employees may benefit from access to 

and use of lifetime income or other 

arrangements that will reduce the risk 

of running out of funds during the 

retirement years. However, both access 

to and use of such arrangements in 

defined contribution plans is limited. 

The Department, taking into 

consideration recommendations of the 

ERISA Advisory Council and others, 

intends to explore what steps, if any, 

it could or should take, by regulation 

or otherwise, to enhance the retirement 

security of workers by increasing access 

to and use of such arrangements. 

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. 

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. 

Timetable: 

Action Date FR Cite 

RFI 02/02/10 75 FR 5253 

RFI Comment Period 

End 

05/03/10 

Public Hearing Notice 08/10/10 75 FR 48367 

Public Hearing 09/14/10 

Review Public Record 04/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Agency Contact: 

Jeffrey J. Turner 

Chief, Division of Regulations, Office of 

Regulations and Interpretations 

Department of Labor 

Employee Benefits Security 

Administration 

200 Constitution Avenue NW. 

FP Building 

Room N–5655 

Washington, DC 20210 

Phone: 202 693–8500 

RIN: 1210–AB33 

DOL—EBSA 

PROPOSED RULE STAGE 

100. DEFINITION OF ‘‘FIDUCIARY’’ 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

29 USC 1002; ERISA sec 3(21); 29 USC 

1135; ERISA sec 505 

CFR Citation: 

29 CFR 2510.3–21(c) 

Legal Deadline: 

None 

Abstract: 

This rulemaking would amend the 

regulatory definition of the term 

‘‘fiduciary’’ set forth at 29 CFR 2510.3- 

21 (c) to more broadly define as 

employee benefit plan fiduciaries 

persons who render investment advice 

to plans for a fee within the meaning 

of section 3(21) of ERISA. The 

amendment would take into account 

current practices of investment advisers 

and the expectations of plan officials 

and participants who receive 

investment advice. 

Statement of Need: 

This rulemaking is needed to bring the 

definition of ‘‘fiduciary’’ into line with 

investment advice practices and to 

recast the current regulation to better 

reflect relationships between 

investment advisers and their employee 

benefit plan clients. The current 

regulation may inappropriately limit 

the types of investment advice 

relationships that should give rise to 

fiduciary duties on the part of the 

investment adviser. 

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 

2510.3-21(c) defines the term fiduciary 

for certain purposes under section 3(21) 

of ERISA. 

Alternatives: 

Alternatives will be considered 

following a determination of the scope 

and nature of the regulatory guidance 

needed by the public. 


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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. 

Timetable: 

Action Date FR Cite 

NPRM 10/22/10 75 FR 65263 

NPRM Comment 

Period End 

01/20/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Agency Contact: 

Jeffrey J. Turner 

Chief, Division of Regulations, Office of 

Regulations and Interpretations 

Department of Labor 

Employee Benefits Security 

Administration 

200 Constitution Avenue NW. 

FP Building 

Room N–5655 

Washington, DC 20210 

Phone: 202 693–8500 

RIN: 1210–AB32 

DOL—Mine Safety and Health 

Administration (MSHA) 

PROPOSED RULE STAGE 

101. RESPIRABLE CRYSTALLINE 

SILICA STANDARD 

Priority: 

Other Significant 

Legal Authority: 

30 USC 811; 30 USC 813 

CFR Citation: 

30 CFR 56 to 57; 30 CFR 70 to 72; 

30 CFR 90 

Legal Deadline: 

None 

Abstract: 

Current standards limit exposures to 

quartz (crystalline silica) in respirable 

dust. The coal mining industry 

standard is based on the formula 10 

mg/m3 divided by the percentage of 

quartz where the quartz percent is 

greater than 5 percent calculated as an 

MRE equivalent concentration. The 

metal and nonmetal mining industry 

standard is based on the 1973 

American Conference of Governmental 

Industrial Hygienists (ACGIH) 

Threshold Limit Values formula: 10 

mg/m3 divided by the percentage of 

quartz plus 2. Overexposure to 

crystalline silica can result in some 

miners developing silicosis, an 

irreversible but preventable lung 

disease, which ultimately may be fatal. 

Both formulas are designed to limit 

exposures to 0.1 mg/m3 (100 ug) of 

silica. The Secretary of Labor’s 

Advisory Committee on the Elimination 

of Pneumoconiosis Among Coal Mine 

Workers made several 

recommendations related to reducing 

exposure to silica. NIOSH recommends 

a 50 ug/m3 exposure limit for 

respirable crystalline silica. MSHA will 

publish a proposed rule to address 

miners’ exposure to respirable 

crystalline silica. 

Statement of Need: 

MSHA standards are outdated; current 

regulations may not protect workers 

from developing silicosis. Evidence 

indicates that miners continue to 

develop silicosis. MSHA’s proposed 

regulatory action exemplifies the 

agency’s commitment to protecting the 

most vulnerable populations while 

assuring broad-based compliance. 

MSHA will regulate based on sound 

science to eliminate or reduce the 

hazards with the broadest and most 

serious consequences. MSHA intends to 

use OSHA’s work on the health effects 

and risk assessment, adapting it as 

necessary for the mining industry. 

Summary of Legal Basis: 

Promulgation of this standard is 

authorized by sections 101 and 103 of 

the Federal Mine Safety and Health Act 

of 1977. 

Alternatives: 

This rulemaking would improve health 

protection from that afforded by the 

existing standards. MSHA will consider 

alternative methods of addressing 

miners’ exposures based on the 

capabilities of the sampling and 

analytical methods. 

Anticipated Cost and Benefits: 

MSHA will prepare estimates of the 

anticipated costs and benefits 

associated with the proposed rule. 

Risks: 

For over 70 years, toxicology 

information and epidemiological 

studies have shown that exposure to 

respirable crystalline silica presents 

potential health risks to miners. These 

potential adverse health effects include 

simple silicosis and progressive 

massive fibrosis (lung scarring). 

Evidence indicates that exposure to 

silica may cause cancer. MSHA 

believes that the health evidence forms 

a reasonable basis for reducing miners’ 

exposure to respirable crystalline silica. 

Timetable: 

Action Date FR Cite 

NPRM 07/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Small Entities Affected: 

Businesses, Governmental Jurisdictions 

Government Levels Affected: 

Local, State 

URL For More Information: 

www.msha.gov/regsinfo.htm 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Patricia W. Silvey 

Director, Office of Standards, Regulations, 

and Variances 

Department of Labor 

Mine Safety and Health Administration 

1100 Wilson Boulevard 

Room 2350 

Arlington, VA 22209–3939 

Phone: 202 693–9440 

Fax: 202 693–9441 

Email: silvey.patricia@dol.gov 

RIN: 1219–AB36 

DOL—MSHA 

102. LOWERING MINERS’ EXPOSURE 

TO COAL MINE DUST, INCLUDING 

CONTINUOUS PERSONAL DUST 

MONITORS 

Priority: 

Other Significant 

Legal Authority: 

30 USC 811; 30 USC 813(h) 

CFR Citation: 

30 CFR 70; 30 CFR 71; 30 CFR 72; 30 

CFR 75; 30 CFR 90 

Legal Deadline: 

None 

Abstract: 

The Federal Coal Mine Health and 

Safety Act of 1969 established the first 

comprehensive respirable dust 


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79598 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

standards for coal mines. These 

standards were designed to reduce the 

incidence of coal workers’ 

pneumoconiosis (CWP) or (black lung) 

and silicosis and eventually eliminate 

these diseases. While significant 

progress has been made toward 

improving the health conditions in our 

Nation’s coal mines, miners continue to 

be at risk of developing occupational 

lung disease, according to the National 

Institute for Occupational Safety and 

Health (NIOSH). In September 1995, 

NIOSH issued a Criteria Document in 

which it recommended that the 

respirable coal mine dust permissible 

exposure limit (PEL) be cut in half. In 

February 1996, the Secretary of Labor 

convened a Federal Advisory 

Committee on the Elimination of 

Pneumoconiosis Among Coal Miners 

(Advisory Committee) to assess the 

adequacy of MSHA’s current program 

and standards to control respirable dust 

in underground and surface coal mines, 

as well as other ways to eliminate black 

lung and silicosis among coal miners. 

The Committee represented the labor, 

industry and academic communities. 

The Committee submitted its report to 

the Secretary of Labor in November 

1996, with the majority of the 

recommendations unanimously 

supported by the Committee members. 

The Committee recommended a 

number of actions to reduce miners’ 

exposure to respirable coal mine dust. 

This proposed rule is an important 

element in MSHA’s Comprehensive 

Black Lung Reduction Strategy 

(Strategy) to ‘‘End Black Lung Now’’ 

and combines the following rulemaking 

actions: (1) ‘‘Occupational Exposure to 

Coal Mine Dust (Lowering Exposure),’’ 

RIN 1219-AB64; (2) ‘‘Verification of 

Underground Coal Mine Operators’ 

Dust Control Plans and Compliance 

Sampling for Respirable Dust,’’ RIN 

1219-AB14; (3) ‘‘Determination of 

Concentration of Respirable Coal Mine 

Dust,’’ RIN 1219-AB18; and (4) 

‘‘Respirable Coal Mine Dust: 

Continuous Personal Dust Monitor 

(CPDM),’’ RIN 1219-AB48. 

Statement of Need: 

Comprehensive respirable dust 

standards for coal mines were designed 

to reduce the incidence, and eventually 

eliminate, CWP and silicosis. While 

significant progress has been made 

toward improving the health conditions 

in our Nation’s coal mines, miners 

remain at risk of developing 

occupational lung disease, according to 

NIOSH. Recent NIOSH data indicates 

increased prevalence of CWP ‘‘clusters’’ 

in several geographical areas, 

particularly in the Southern 

Appalachian Region. 

Summary of Legal Basis: 

Promulgation of this regulation is 

authorized by the Federal Mine Safety 

and Health Act of 1977 as amended by 

the Mine Improvement and New 

Emergency Response Act of 2006. 

Alternatives: 

MSHA is considering amendments, 

revisions, and additions to existing 

standards. 

Anticipated Cost and Benefits: 

MSHA developed a preliminary 

regulatory economic analysis to 

accompany the proposed rule. 

Risks: 

Respirable coal dust is one of the most 

serious occupational hazards in the 

mining industry. Occupational 

exposure to excessive levels of 

respirable coal mine dust can cause 

coal workers’ pneumoconiosis and 

silicosis, which are potentially 

disabling and can cause death. MSHA 

is pursuing both regulatory and 

nonregulatory actions to eliminate these 

diseases through the control of coal 

mine respirable dust levels in mines 

and reduction of miners’ exposure. 

MSHA developed a risk assessment to 

accompany the proposed rule. 

Timetable: 

Action Date FR Cite 

NPRM 10/19/10 75 FR 64412 

Hearings 11/15/10 75 FR 69617 

NPRM Comment 

Period End 

02/28/11 

NPRM–Rescheduling 

of Public Hearings; 

Correction 

11/30/10 75 FR 73995 

Post Hearing 

Comment Period 

End 

02/28/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

URL For More Information: 

http://www.msha.gov/S&HINFO/ 

BlackLung/homepage2009.asp 

URL For Public Comments: 

http://www.regulations.gov 

Agency Contact: 

Patricia W. Silvey 

Director, Office of Standards, Regulations, 

and Variances 

Department of Labor 

Mine Safety and Health Administration 

1100 Wilson Boulevard 

Room 2350 

Arlington, VA 22209–3939 

Phone: 202 693–9440 

Fax: 202 693–9441 

Email: silvey.patricia@dol.gov 

RIN: 1219–AB64 

DOL—MSHA 

103. SAFETY AND HEALTH 

MANAGEMENT PROGRAMS FOR 

MINES 

Priority: 

Other Significant 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

30 USC 811 and 812 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

MSHA held public meetings and 

gathered information and suggestions 

from the mining community on 

effective, comprehensive safety and 

health management programs, 

including programs used in the mining 

industry. MSHA will use all 

information received to develop a 

proposed rule for safety and health 

management programs to eliminate 

hazards and prevent injuries and 

illnesses at mines. 

Statement of Need: 

Mining is one of the most hazardous 

industries in this country. Yet year after 

year, many mines experience low 

injury and illness rates and low 

violation rates. For these mine 

operators, preventing harm to their 

miners is more than compliance with 

safety and health requirements; it 

reflects an embodiment of a culture of 

safety—from CEO to the miner to the 

contractor. This culture of safety 

derives from a commitment to a 

systematic, effective, comprehensive 

management of safety and health at 

mines with full participation of all 

miners. 

MSHA believes requiring effective 

safety and health management 


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programs in mining will create a 

sustained industry-wide effort to 

eliminate hazards and will result in the 

prevention of injuries and illnesses. 

Summary of Legal Basis: 

Promulgation of this standard is 

authorized by section 101 of the 

Federal Mine Safety and Health Act of 

1977 as amended by the Mine 

Improvement and New Emergency 

Response Act of 2006. 

Alternatives: 

No reasonable alternatives to this 

regulation would be as comprehensive 

or as effective in eliminating hazards 

and preventing injuries and illnesses. 

Anticipated Cost and Benefits: 

MSHA will develop a preliminary 

regulatory economic analysis to 

accompany the proposed rule. 

Risks: 

The lack of a comprehensive safety and 

health management program 

contributes to a higher incidence of 

injury and illness rates and higher 

violation rates. 

Timetable: 

Action Date FR Cite 

NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Patricia W. Silvey 

Director, Office of Standards, Regulations, 

and Variances 

Department of Labor 

Mine Safety and Health Administration 

1100 Wilson Boulevard 

Room 2350 

Arlington, VA 22209–3939 

Phone: 202 693–9440 

Fax: 202 693–9441 

Email: silvey.patricia@dol.gov 

RIN: 1219–AB71 

DOL—MSHA 

104. PATTERN OF VIOLATIONS 

Priority: 

Other Significant 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

30 USC 814(e); 30 USC 957 

CFR Citation: 

30 CFR 104 

Legal Deadline: 

None 

Abstract: 

MSHA is preparing a proposed rule to 

revise the Agency’s existing regulation 

for pattern of violations contained in 

30 CFR part 104. MSHA has 

determined that the existing pattern 

criteria and procedures do not reflect 

the statutory intent for section 104(e) 

of the Federal Mine Safety and Health 

Act of 1977 (Mine Act) that operators 

manage health and safety conditions at 

mines so that the root causes of 

significant and substantial (S&S) 

violations are addressed before they 

become a hazard to the health and 

safety of miners. The legislative history 

of the Mine Act explains that Congress 

intended the pattern of violations tool 

be used for operators who have 

demonstrated a disregard for the health 

and safety of miners. The proposal 

would reflect statutory intent, simplify 

the pattern of violations criteria, and 

improve consistency in applying the 

patterns of violations criteria. 

Statement of Need: 

The pattern of violations provision was 

a new enforcement tool in the Mine 

Act. The Mine Act places the ultimate 

responsibility for ensuring the safety 

and health of miners on mine 

operators. The goal of the pattern of 

violations proposed rule is to compel 

operators to manage health and safety 

conditions so that the root causes of 

S&S violations are found and fixed 

before they become a hazard to miners. 

MSHA’s existing regulation is not 

consistent with the language, purpose, 

and legislative history of the Mine Act 

and hinders the Agency’s use of pattern 

of violations to identify chronic 

violators who thumb their noses at the 

law by a continuing cycle of citation 

and abatement. 

Summary of Legal Basis: 

Promulgation of this standard is 

authorized by sections 104(e) and 957 

of the Federal Mine Safety and Health 

Act of 1977. 

Alternatives: 

MSHA will consider alternative criteria 

for determining when a pattern of 

significant and substantial violations 

exists in order to improve health and 

safety conditions in mines and provide 

protection for miners. Congress 

provided the Secretary with broad 

discretion in determining criteria, 

recognizing that MSHA may need to 

modify the criteria as Agency 

experience dictates. 

Anticipated Cost and Benefits: 

MSHA will prepare estimates of the 

anticipated costs and benefits 

associated with the proposed rule. 

Risks: 

Mine operators with a chronic history 

of persistent serious violations 

needlessly expose miners to the same 

hazards again and again. These 

operators demonstrate a disregard for 

the safety and health of miners; this 

indicates a serious safety and health 

management problem at the mine. The 

existing regulation has not been 

effective in reducing repeated risks to 

miners at these mines. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

URL For More Information: 

http://www.msha.gov/regsinfo.htm 

URL For Public Comments: 

http://www.regulations.gov 

Agency Contact: 

Patricia W. Silvey 

Director, Office of Standards, Regulations, 

and Variances 

Department of Labor 

Mine Safety and Health Administration 

1100 Wilson Boulevard 

Room 2350 

Arlington, VA 22209–3939 

Phone: 202 693–9440 

Fax: 202 693–9441 

Email: silvey.patricia@dol.gov 

RIN: 1219–AB73 

DOL—MSHA 

105. ∑ MAINTENANCE OF 

INCOMBUSTIBLE CONTENT OF ROCK 

DUST IN UNDERGROUND COAL 

MINES 

Priority: 

Other Significant 


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Legal Authority: 

30 USC 811, 864 

CFR Citation: 

30 CFR sec 75.403 

Legal Deadline: 

None 

Abstract: 

The Mine Safety and Health 

Administration (MSHA) issued an 

emergency temporary standard (ETS) 

under section 101(b) of the Federal 

Mine Safety and Health Act of 1977 

in response to the grave danger that 

miners in underground bituminous coal 

mines face when accumulations of coal 

dust are not made inert. MSHA 

concluded from investigations of mine 

explosions and other reports that 

immediate action was necessary to 

protect miners. 

Accumulations of coal dust can ignite, 

resulting in an explosion, or after an 

explosion, it can propagate, increasing 

the severity of the explosion. The ETS 

requires mine operators to increase the 

incombustible content of combined coal 

dust, rock dust, and other dust to at 

least 80 percent in underground areas 

of bituminous mines. The ETS further 

requires that the incombustible content 

of such combined dust be raised 0.4 

percent for each 0.1 percent of methane 

present. The ETS strengthens the 

protection for miners by reducing the 

potential for a coal mine explosion. 

Statement of Need: 

MSHA determined that a revised 

standard for ‘‘Maintenance of 

Incombustible Content of Rock Dust’’ is 

necessary to immediately protect 

underground coal miners from hazards 

of coal dust explosions. This 

determination is based on: (1) MSHA’s 

accident investigation reports of mine 

explosions in intake air courses that 

involved coal dust (Dubaniewicz 2009); 

(2) the National Institute for 

Occupational Safety and Health’s 

Report of Investigations 9679 

(Cashdollar et al. 2010), 

‘‘Recommendations for a New Rock 

Dusting Standard to Prevent Coal Dust 

Explosions in Intake Airways‘‘; and (3) 

MSHA’s experience and data. 

Summary of Legal Basis: 

Promulgation of this standard is 

authorized by section 101(b) of the 

Federal Mine Safety and Health Act of 

1977. 

Alternatives: 

MSHA will consider revisions to the 

ETS, based on public comments 

received during the rulemaking process. 

Anticipated Cost and Benefits: 

MSHA estimates that the ETS would 

result in approximately $22.0 million 

in yearly costs for the underground 

bituminous coal mining industry. The 

ETS provides additional safety 

protection for miners in underground 

bituminous coal mines from the 

explosion hazard of coal and other 

dusts. MSHA estimates that, on 

average, the ETS would prevent 

approximately 1.5 deaths every year 

and would prevent one additional 

injury about every 4 years. 

Risks: 

Based on NIOSH’s data and 

recommendations, and MSHA’s data 

and experience, the Secretary 

determined that miners are exposed to 

grave danger in areas of underground 

bituminous coal mines that are not 

properly and sufficiently rock dusted in 

accordance with the requirements in 

this ETS. 

Timetable: 

Action Date FR Cite 

Emergency 

Temporary 

Standard 

09/23/10 75 FR 57849 

Hearing 10/26/10 

Hearing 10/28/10 

Hearing 11/16/10 

Hearing 11/18/10 

Comment Period End 12/20/10 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

URL For More Information: 

www.msha.gov/regsinfo.htm 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Patricia W. Silvey 

Director, Office of Standards, Regulations, 

and Variances 

Department of Labor 

Mine Safety and Health Administration 

1100 Wilson Boulevard 

Room 2350 

Arlington, VA 22209–3939 

Phone: 202 693–9440 

Fax: 202 693–9441 

Email: silvey.patricia@dol.gov 

RIN: 1219–AB76 

DOL—MSHA 

FINAL RULE STAGE 

106. PROXIMITY DETECTION 

SYSTEMS FOR UNDERGROUND 

MINES 

Priority: 

Other Significant 

Legal Authority: 

30 USC 811 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

The Mine Safety and Health 

Administration (MSHA) will issue an 

emergency temporary standard (ETS) 

under section 101(b) of the Federal 

Mine Safety and Health Act of 1977 

in response to the grave danger that 

miners face when working near mobile 

equipment in underground mines. 

MSHA has concluded, from 

investigations of accidents involving 

mobile equipment and other reports, 

that immediate action is necessary to 

protect miners. To date, in 2010, there 

have been five fatalities resulting from 

crushing and pinning accidents. 

Mobile equipment can pin, crush, or 

strike a miner working near the 

equipment. Proximity detection 

technology can prevent these types of 

accidents. The ETS would strengthen 

the protection for underground miners 

by reducing the potential of pinning, 

crushing or striking hazards associated 

with working close to mobile 

equipment. As a part of the Secretary’s 

strategy for securing safe and healthy 

workplaces, the Mine Safety and Health 

Administration will undertake 

regulatory action related to reducing 


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injuries and fatalities to workers in 

close proximity to moving equipment 

and vehicles. 

Statement of Need: 

Mining is one of the most hazardous 

industries in this country. Miners 

continue to be injured or killed 

resulting from pinning, crushing, or 

striking accidents involving mobile 

equipment. Equipment is available to 

help prevent accidents that cause 

debilitating injuries and accidental 

death. 

Summary of Legal Basis: 

Promulgation of this standard is 

authorized by section 101(b) of the 

Federal Mine Safety and Health Act of 

1977 as amended by the Mine 

Improvement and New Emergency 

Response Act of 2006. 

Alternatives: 

No reasonable alternatives to this 

regulation would be as comprehensive 

or as effective in eliminating hazards 

and preventing injuries. 

Anticipated Cost and Benefits: 

MSHA will develop a regulatory 

economic analysis to accompany the 

ETS. 

Risks: 

The lack of proximity detection systems 

on mobile equipment in underground 

mines contributes to a higher incidence 

of debilitating injuries and accidental 

deaths. 

Timetable: 

Action Date FR Cite 

Request for 

Information (RFI) 

02/01/10 75 FR 5009 

Comment Period 

Ended 

04/02/10 

Emergency 

Temporary 

Standard 

03/00/11 

Final Action 12/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Patricia W. Silvey 

Director, Office of Standards, Regulations, 

and Variances 

Department of Labor 

Mine Safety and Health Administration 

1100 Wilson Boulevard 

Room 2350 

Arlington, VA 22209–3939 

Phone: 202 693–9440 

Fax: 202 693–9441 

Email: silvey.patricia@dol.gov 

RIN: 1219–AB65 

DOL—Occupational Safety and Health 

Administration (OSHA) 

PRERULE STAGE 

107. INFECTIOUS DISEASES 

Priority: 

Economically Significant. Major status 

under 5 USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

5 USC 533; 29 USC 657 and 658; 29 

USC 660; 29 USC 666; 29 USC 669; 

29 USC 673; . . . 

CFR Citation: 

29 CFR 1910 

Legal Deadline: 

None 

Abstract: 

Employees in health care and other 

high-risk environments face longstanding infectious diseases hazards 

such as tuberculosis (TB), varicella 

disease (chickenpox, shingles), and 

measles (rubeola), as well as new and 

emerging infectious disease threats, 

such as Severe Acute Respiratory 

Syndrome (SARS) and pandemic 

influenza. Health care workers and 

workers in related occupations or who 

are exposed in other high-risk 

environments are at increased risk of 

contracting TB, SARS, MRSA, and 

other infectious diseases that can be 

transmitted through a variety of 

exposure routes. OSHA is concerned 

about the ability of employees to 

continue to provide health care and 

other critical services without 

unreasonably jeopardizing their health. 

OSHA is considering the need for a 

standard to ensure that employers 

establish a comprehensive infection 

control program and control measures 

to protect employees from infectious 

disease exposures to pathogens that can 

cause significant disease. Workplaces 

where such control measures might be 

necessary include: health care, 

emergency response, correctional 

facilities, homeless shelters, drug 

treatment programs, and other 

occupational settings where employees 

can be at increased risk of exposure to 

potentially infectious people. A 

standard could also apply to 

laboratories which handle materials 

that may be a source of pathogens, and 

to pathologists, coroners’ offices, 

medical examiners, and mortuaries. 

OSHA published an RFI on May 6, 

2010, the comment period closed on 

August 4, 2010. OSHA is currently 

analyzing the comments submitted by 

stakeholders. 

Statement of Need: 

In 2007, the healthcare and social 

assistance sector as a whole had 16.5 

million employees. Healthcare 

workplaces can range from small 

private practices of physicians to 

hospitals that employ thousands of 

workers. In addition, healthcare is 

increasingly being provided in other 

settings such as nursing homes, freestanding surgical and outpatient 

centers, emergency care clinics, 

patients’ homes, and prehospitalization 

emergency care settings. The Agency is 

particularly concerned by studies that 

indicate that transmission of infectious 

diseases to both patients and healthcare 

workers may be occurring as a result 

of incomplete adherence to recognized, 

but voluntary, infection control 

measures. Another concern is the 

movement of healthcare delivery from 

the traditional hospital setting, with its 

greater infrastructure and resources to 

effectively implement infection control 

measures, into more diverse and 

smaller workplace setting with less 

infrastructure and fewer resources, but 

with an expanding worker population. 

Summary of Legal Basis: 

The Occupational Safety and Health 

Act of 1970 authorizes the Secretary of 

Labor to set mandatory occupational 

safety and health standards to assure 

safe and healthful working conditions 

for working men and women (29 U.S.C. 

651). 

Alternatives: 

The alternative to the proposed 

rulemaking would be to take no 

regulatory action. 


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Anticipated Cost and Benefits: 

The estimates of the costs and benefits 

are still under development. 

Risks: 

Analysis of risks is still under 

development. 

Timetable: 

Action Date FR Cite 

Request for 

Information (RFI) 

05/06/10 75 FR 24835 

RFI Comment Period 

End 

08/04/10 

Analyze Comments 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Dorothy Dougherty 

Director, Directorate of Standards and 

Guidance 

Department of Labor 

Occupational Safety and Health 

Administration 

200 Constitution Avenue NW. 

FP Building 

Room N–3718 

Washington, DC 20210 

Phone: 202 693–1950 

Fax: 202 693–1678 

Email: dougherty.dorothy@dol.gov 

RIN: 1218–AC46 

DOL—OSHA 

108. INJURY AND ILLNESS 

PREVENTION PROGRAM 

Priority: 

Economically Significant. Major status 

under 5 USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

29 USC 653; 29 USC 655(b); 29 USC 

657 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

OSHA is developing a rule requiring 

employers to implement an Injury and 

Illness Prevention Program. It involves 

planning, implementing, evaluating, 

and improving processes and activities 

that protect employee safety and health. 

OSHA has substantial data on 

reductions in injuries and illnesses 

from employers who have implemented 

similar effective processes. The Agency 

currently has voluntary Safety and 

Health Program Management 

Guidelines (54 FR 3904-3916), 

published in 1989. An injury and 

illness prevention rule would build on 

these guidelines as well as lessons 

learned from successful approaches and 

best practices under OSHA’s Voluntary 

Protection Program Safety and Health 

Achievement Recognition Program and 

similar industry and international 

initiatives such as American National 

Standards Institute/American Industrial 

Hygiene Association Z10 and 

Occupational Health and Safety 

Assessment Series 18001. Twelve States 

have similar rules. 

Statement of Need: 

There are approximately 5,000 

workplace fatalities and approximately 

3.5 million serious workplace injuries 

every year. There are also many 

workplace illnesses caused by exposure 

to common chemical, physical, and 

biological agents. OSHA believes that 

an injury and illness prevention 

program is a universal intervention that 

can be used in a wide spectrum of 

workplaces to dramatically reduce the 

number and severity of workplace 

injuries. Such programs have been 

shown to be effective in many 

workplaces in the United States and 

internationally. 

Summary of Legal Basis: 

The Occupational Safety and Health 

Act of 1970 authorizes the Secretary of 

Labor to set mandatory occupational 

safety and health standards to assure 

safe and healthful working conditions 

for working men and women (29 U.S.C. 

651). 

Alternatives: 

The alternatives to this rulemaking 

would be to issue guidance, recognition 

programs, or allow for the states to 

develop individual regulations. OSHA 

has used voluntary approaches to 

address the need, including publishing 

Safety and Health Program Management 

Guidelines in 1989. In addition, OSHA 

has two recognition programs, the 

Voluntary Protection Program (known 

as VPP), and the Safety and Health 

Achievement Recognition Program 

(known as SHARP). These programs 

recognize workplaces with effective 

safety and health programs. Several 

States have issued regulations that 

require employers to establish effective 

safety and health programs. 

Anticipated Cost and Benefits: 

The scope of the proposed rulemaking 

and the costs and benefits are still 

under development for this regulatory 

action. 

Risks: 

A detailed risk analysis is underway. 

Timetable: 

Action Date FR Cite 

Stakeholder Meetings 06/03/10 

Initiate SBREFA 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Dorothy Dougherty 

Director, Directorate of Standards and 

Guidance 

Department of Labor 

Occupational Safety and Health 

Administration 

200 Constitution Avenue NW. 

FP Building 

Room N–3718 

Washington, DC 20210 

Phone: 202 693–1950 

Fax: 202 693–1678 

Email: dougherty.dorothy@dol.gov 

RIN: 1218–AC48 

DOL—OSHA 

109. ∑ BACKING OPERATIONS 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

29 USC 655(b) 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 


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Abstract: 

NIOSH reports that half of the fatalities 

involving construction equipment occur 

while the equipment is backing. 

Backing accidents cause 500 deaths and 

15,000 injuries per year. Emerging 

technologies in the field of backing 

operations include after market devices, 

such as camera, radar, and sonar, to 

help monitor the presence of workers 

on foot in blind areas, and new 

monitoring technology, such as tagbased warning systems that use radio 

frequency (RFID) and magnetic field 

generators on equipment to detect 

electronic tags worn by workers. 

Statement of Need: 

A study by the Census of Fatal 

Occupational Injuries found that the 

most common primary sources of injury 

to be trucks (45%), road grading and 

surfacing machinery (15%), and cars 

(15%). That same study showed that 

of the 465 vehicle and equipmentrelated fatalities within work zones, 

318 workers on foot were struck by a 

vehicle. Incidents involving backing 

vehicles were prominent among the 

worker-on-foot fatalities that occurred 

(51%). The primary injury sources of 

fatalities of workers on foot struck by 

a construction vehicle were trucks 

(61%) and construction machines 

(30%). OSHA believes that regulatory 

action is necessary to address risks 

associated with backup operations. 

Summary of Legal Basis: 

The Occupational Safety and Health 

Act of 1970 authorizes the Secretary of 

Labor to set mandatory occupational 

safety and health standards to assure 

safe and healthful working conditions 

for working men and women (29 U.S.C. 

651). 

Alternatives: 

The alternative to the proposed 

rulemaking would be to take no 

regulatory action. 

Anticipated Cost and Benefits: 

The estimates of the costs and benefits 

are still under development. 

Risks: 

Analysis of risks is still under 

development. 

Timetable: 

Action Date FR Cite 

RFI 05/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Agency Contact: 

Ben Bare 

Acting Director, Directorate of 

Construction 

Department of Labor 

Occupational Safety and Health 

Administration 

200 Constitution Avenue NW. 

FP Building 

Room N–3468 

Washington, DC 20210 

Phone: 202 693–2020 

Fax: 202 693–1689 

RIN: 1218–AC52 

DOL—OSHA 

PROPOSED RULE STAGE 

110. OCCUPATIONAL EXPOSURE TO 

CRYSTALLINE SILICA 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect State, local or 

tribal governments. 

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 proposed by the American 

Conference of Governmental Industrial 

Hygienists (ACGIH) in 1968 

(PEL=10mg/cubic meter/(% silica + 2), 

as respirable dust). The current PEL for 

construction and shipyards (derived 

from ACGIH’s 1970 Threshold Limit 

Value) is based on particle counting 

technology, which is considered 

obsolete. NIOSH and ACGIH 

recommend 50μg/m3 and 25μg/m3 

exposure limits, respectively, 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 has published 

recommended standards 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. OSHA is currently 

developing a NPRM. 

Statement of Need: 

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. In 2005, the most recent year 

for which data is available, silicosis 

was identified on 161 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 has designated crystalline silica 

as carcinogenic to humans, and the 

National Toxicology Program has 

concluded that respirable crystalline 

silica is 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 diseases. 

Exposure studies and OSHA 

enforcement data indicate that some 


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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 shipyard 

workers, 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. 

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 

Initiated Peer Review 

of Health Effects 

and Risk 

Assessment 

05/22/09 

Completed Peer 

Review 

01/24/10 

NPRM 04/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Federal 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Agency Contact: 

Dorothy Dougherty 

Director, Directorate of Standards and 

Guidance 

Department of Labor 

Occupational Safety and Health 

Administration 

200 Constitution Avenue NW. 

FP Building 

Room N–3718 

Washington, DC 20210 

Phone: 202 693–1950 

Fax: 202 693–1678 

Email: dougherty.dorothy@dol.gov 

RIN: 1218–AB70 

DOL—OSHA 

111. OCCUPATIONAL INJURY AND 

ILLNESS RECORDING AND 

REPORTING REQUIREMENTS— 

MODERNIZING OSHA’S REPORTING 

SYSTEM 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

29 USC 657 

CFR Citation: 

29 CFR 1904 

Legal Deadline: 

None 

Abstract: 

OSHA is proposing changes to its 

reporting system for occupational 

injuries and illnesses. An updated and 

modernized reporting system would 

enable a more efficient and timely 

collection of data and would improve 

the accuracy and availability of the 

relevant records and statistics. This 

proposal involves modification to 29 

CFR part 1904.41 to expand OSHA’s 

legal authority to collect and make 

available injury and illness information 

required under part 1904. 

Statement of Need: 

The collection of establishment specific 

injury and illness data in electronic 

format on a timely basis is needed to 

help OSHA, employers, employees, 

researchers, and the public more 

effectively prevent workplace injuries 

and illnesses, as well as support 

President Obama’s Open Government 

Initiative to increase the ability of the 

public to easily find, download, and 

use the resulting dataset generated and 

held by the Federal Government. 

Summary of Legal Basis: 

The Occupational Safety and Health 

Act of 1970 authorizes the Secretary of 

Labor to develop and maintain an 

effective program of collection, 

compilation, and analysis of 

occupational safety and health statistics 

(29 U.S.C. 673). 

Alternatives: 

The alternative to the proposed 

rulemaking would be to take no 

regulatory action. 

Anticipated Cost and Benefits: 

The estimates of the costs and benefits 

are still under development. 

Risks: 

Analysis of risks is still under 

development. 

Timetable: 

Action Date FR Cite 

Stakeholder Meetings 05/25/10 75 FR 24505 

Comment Period End 06/18/10 

NPRM 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

None 

Agency Contact: 

Keith Goddard 

Director, Directorate of Evaluation and 

Analysis 

Department of Labor 

Occupational Safety and Health 

Administration 

200 Constitution Avenue NW. 

FP Building 

Room N–3718 

Washington, DC 20210 

Phone: 202 693–2400 

Fax: 202 693–1641 

Email: goddard.keith@dol.gov 

RIN: 1218–AC49 

DOL—OSHA 

FINAL RULE STAGE 

112. HAZARD COMMUNICATION 

Priority: 

Economically Significant. Major under 

5 USC 801. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79605 

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 1910.1200; 29 CFR 1915.1200; 

29 CFR 1917.28; 29 CFR 1918.90; 29 

CFR 1926.59; 29 CFR 1928.21 

Legal Deadline: 

None 

Abstract: 

OSHA’s Hazard Communication 

Standard (HCS) requires chemical 

manufacturers and importers to 

evaluate the hazards of the chemicals 

they produce or import, and prepare 

labels and material safety data sheets 

to convey the hazards and associated 

protective measures to users of the 

chemicals. All employers with 

hazardous chemicals in their 

workplaces are required to have a 

hazard communication program, 

including labels on containers, material 

safety data sheets (MSDS), and training 

for employees. Within the United States 

(U.S.), there are other Federal agencies 

that also have requirements for 

classification and labeling of chemicals 

at different stages of the life cycle. 

Internationally, there are a number of 

countries that have developed similar 

laws that require information about 

chemicals to be prepared and 

transmitted to affected parties. These 

laws vary with regard to the scope of 

substances covered, definitions of 

hazards, the specificity of requirements 

(e.g., specification of a format for 

MSDSs), and the use of symbols and 

pictograms. The inconsistencies 

between the various laws are 

substantial enough that different labels 

and safety data sheets must often be 

used for the same product when it is 

marketed in different nations. 

The diverse and sometimes conflicting 

national and international requirements 

can create confusion among those who 

seek to use hazard information. Labels 

and safety data sheets may include 

symbols and hazard statements that are 

unfamiliar to readers or not well 

understood. Containers may be labeled 

with such a large volume of 

information that important statements 

are not easily recognized. Development 

of multiple sets of labels and safety 

data sheets is a major compliance 

burden for chemical manufacturers, 

distributors, and transporters involved 

in international trade. Small businesses 

may have particular difficulty in coping 

with the complexities and costs 

involved. 

As a result of this situation, and in 

recognition of the extensive 

international trade in chemicals, there 

has been a long-standing effort to 

harmonize these requirements and 

develop a system that can be used 

around the world. In 2003, the United 

Nations adopted the Globally 

Harmonized System of Classification 

and Labeling of Chemicals (GHS). 

Countries are now adopting the GHS 

into their national regulatory systems. 

Statement of Need: 

Multiple sets of requirements for labels 

and safety data sheets present a 

compliance burden for U.S. 

manufacturers, distributors, and 

transports involved in international 

trade. The comprehensibility of hazard 

information and worker safety will be 

enhanced as the GHS will: (1) Provide 

consistent information and definitions 

for hazardous chemicals; (2) address 

stakeholder concerns regarding the 

need for a standardized format for 

material safety data sheets; and (3) 

increase understanding by using 

standardized pictograms and 

harmonized hazard statements. The 

increase in comprehensibility and 

consistency will reduce confusion and 

thus improve worker safety and health. 

In addition, the adoption of the GHS 

would facilitate international trade in 

chemicals, reduce the burdens caused 

by having to comply with differing 

requirements for the same product, and 

allow companies that have not had the 

resources to deal with those burdens 

to be involved in international trade. 

This is particularly important for small 

producers who may be precluded 

currently from international trade 

because of the compliance resources 

required to address the extensive 

regulatory requirements for 

classification and labeling of chemicals. 

Thus every producer is likely to 

experience some benefits from domestic 

harmonization, in addition to the 

benefits that will accrue to producers 

involved in international trade. Several 

nations, including the European Union, 

have adopted the GHS with an 

implementation schedule through 2015. 

U.S. manufacturers, employers, and 

employees will be at a disadvantage in 

the event that our system of hazard 

communication is not in compliance 

with the GHS. 

Summary of Legal Basis: 

The Occupational Safety and Health 

Act of 1970 authorizes the Secretary of 

Labor to set mandatory occupational 

safety and health standards to assure 

safe and healthful working conditions 

for working men and women (29 U.S.C. 

651). 

Alternatives: 

The alternative to the proposed 

rulemaking would be to take no 

regulatory action. 

Anticipated Cost and Benefits: 

The estimates of the costs and benefits 

are still under development. 

Risks: 

OSHA’s risk analysis is under 

development. 

Timetable: 

Action Date FR Cite 

ANPRM 09/12/06 71 FR 53617 

ANPRM Comment 

Period End 

11/13/06 

Complete Peer 

Review of 

Economic Analysis 

11/19/07 

NPRM 09/30/09 74 FR 50279 

NPRM Comment 

Period End 

12/29/09 

Hearing 03/02/10 

Hearing 03/31/10 

Post Hearing 

Comment Period 

End 

06/01/10 

Final Action 08/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Local, State 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Agency Contact: 

Dorothy Dougherty 

Director, Directorate of Standards and 

Guidance 

Department of Labor 

Occupational Safety and Health 

Administration 

200 Constitution Avenue NW. 

FP Building 

Room N–3718 

Washington, DC 20210 

Phone: 202 693–1950 

Fax: 202 693–1678 

Email: dougherty.dorothy@dol.gov 

RIN: 1218–AC20 

BILLING CODE 4510–23–S 


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79606 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

DEPARTMENT OF TRANSPORTATION 

(DOT) 

Introduction: Department Overview 

and Summary of Regulatory Priorities 

The Department of Transportation 

(DOT) consists of 10 operating 

administrations and the Office of the 

Secretary, each of which has statutory 

responsibility for a wide range of 

regulations. DOT regulates safety in the 

aviation, motor carrier, railroad, motor 

vehicle, commercial space, and pipeline 

transportation areas. DOT also regulates 

aviation consumer and economic issues 

and provides financial assistance for 

programs involving highways, airports, 

public transportation, the maritime 

industry, railroads, and motor vehicle 

safety. The Department writes 

regulations to carry out a variety of 

statutes ranging from the Americans 

with Disabilities Act to the Uniform 

Time Act. Finally, DOT develops and 

implements a wide range of regulations 

that govern internal programs such as 

acquisitions 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’s Regulatory Priorities 

The Department’s regulatory priorities 

respond to the challenges and 

opportunities we face. Our mission 

generally is as follows: 

The national objectives of general 

welfare, economic growth and stability, 

and the security of the United States 

require the development of 

transportation policies and programs 

that contribute to providing fast, safe, 

efficient, and convenient transportation 

at the lowest cost consistent with those 

and other national objectives, including 

the efficient use and conservation of the 

resources of the United States. 

To help us achieve our mission, we 

have five strategic goals: 

• Safety: Improve public health and 

safety by reducing transportationrelated fatalities and injuries. 

• State of Good Repair: Ensure the U.S. 

proactively maintains its critical 

transportation infrastructure in a state 

of good repair. 

• Economic Competitiveness: Promote 

transportation policies and 

investments that bring lasting and 

equitable economic benefits to the 

Nation and its citizens. 

• Livable Communities: Foster livable 

communities through place-based 

policies and investments that increase 

transportation choices and access to 

transportation services. 

• Environmental Sustainability: 

Advance environmentally sustainable 

policies and investments that reduce 

carbon and other harmful emissions 

from transportation sources. 

In identifying our regulatory priorities 

for the next year, the Department 

considered its mission and goals and 

focused on a number of factors, 

including the following: 

• The relative risk being addressed 

• Requirements imposed by statute or 

other law 

• Actions on the National Transportation 

Safety Board ‘‘Most Wanted List’’ 

• The costs and benefits of the 

regulations 

• The advantages to non-regulatory 

alternatives 

• Opportunities for deregulatory action 

• The enforceability of any rule, 

including the effect on agency 

resources 

This regulatory plan identifies the 

Department’s regulatory priorities—the 

17 pending rulemakings chosen from 

among the dozens of significant 

rulemakings listed in the Department’s 

broader regulatory agenda that the 

Department believes will merit special 

attention in the upcoming year. The 

rules included in the regulatory plan 

embody the Department’s focus on our 

strategic goals. 

The regulatory plan reflects the 

Department’s primary focus on safety— 

a focus that extends across several 

modes of transportation. For example: 

• The Federal Aviation Administration 

(FAA) will continue to enhance the 

safety of our airways by its initiative 

to revise rest requirements for 

commercial pilots. 

• The Federal Motor Carrier Safety 

Administration (FMCSA) has initiated 

rulemakings to strengthen the 

requirements for Electronic On-Board 

Recorders. 

• Both FMCSA and the Federal Railroad 

Administration (FRA) are working to 

improve safety by regulating the 

maximum amount of time commercial 

drivers and conductors can operate 

their vehicles. 

• National Highway Traffic Safety 

Administration (NHTSA) will 

continue its rulemaking to reduce 

death and injury resulting from 

incidents involving vehicle drivers 

backing over people. 

• FMCSA and the Pipeline and 

Hazardous Materials Safety 

Administration (PHMSA) are focusing 

on important rulemaking initiatives 

for address distracted driving from the 

use of electronic devices. 

We are taking actions to address other 

important issues. For example: 

• NHTSA is engaged in two major 

rulemakings to address fuel economy 

standards for both light and heavy 

duty vehicles. 

• Office of the Secretary of 

Transportation (OST) is focused on its 

second major aviation consumer 

rulemaking designed to further 

safeguard the interests of consumers 

flying the Nation’s skies. 

Each of the rulemakings in the 

regulatory plan is described below in 

detail. In order to place them in context, 

we first review the Department’s 

regulatory philosophy and our 

initiatives to educate and inform the 

public about transportation safety 

issues. We then describe the role in the 

Department’s regulatory process and 

other important regulatory initiatives of 

OST and of each of the Department’s 

components. Since each transportation 

‘‘mode’’ within the Department has its 

own area of focus, we summarize the 

regulatory priorities of each mode and 

of OST, which supervises and 

coordinates modal initiatives and has its 

own regulatory responsibilities, such as 

consumer protection in the aviation 

industry. 

The Department’s Regulatory 

Philosophy and Initiatives 

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 regulation does not impose 

unreasonable mandates. 


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The Department stresses the 

importance of conducting high quality 

rulemakings in a timely manner and 

reducing the number of old 

rulemakings. To implement this, the 

Department has required the following 

actions: (1) Regular meetings of senior 

DOT officials to ensure effective policy 

leadership and timely decisions, (2) 

effective tracking and coordination of 

rulemakings, (3) regular reporting, (4) 

early briefings of interested officials, (5) 

regular training of staff, and (6) adequate 

allocations of resources. The 

Department has achieved significant 

success because of this effort. It allows 

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. A few examples 

include: The Department’s development 

of regulatory process and related 

training courses for its employees; its 

use of an electronic, Internet-accessible 

docket that can also be used to submit 

comments electronically; a ‘‘list serve’’ 

that allows the public to sign up for email notification when the Department 

issues a rulemaking document; creation 

of an electronic rulemaking tracking and 

coordination system; the use of direct 

final rulemaking; the use of regulatory 

negotiation; an expanded Internet page 

that provides important regulatory 

information, including ‘‘effects’’ reports 

and status reports (http://regs.dot.gov/); 

and the use of Internet blogs and other 

Web 2.0 technology to increase and 

enhance public participation in its 

rulemaking process. 

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, Executive 

Order 12866, and the Department’s 

Regulatory Policies and Procedures. 

This includes determining whether the 

rules would be more understandable if 

they were written using a plain language 

approach. Appendix D to our regulatory 

agenda highlights our efforts in this 

area. 

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 

either rules are completed in a timely 

manner or delays are identified and 

fixed. Through this tracking system, a 

monthly status 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 quality 

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 the Administrative 

Procedure Act, Executive Order 12866 

(Regulatory Planning and Review), 

DOT’s Regulatory Policies and 

Procedures, and other legal and policy 

requirements affecting rulemaking. 

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 

other rules that affect multiple 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 

related analyses; and data quality, 

including peer reviews. 

OST also leads and coordinates the 

Department’s response to the Office of 

Management and Budget’s (OMB) 

intergovernmental review of other 

agencies’ significant rulemaking 

documents and to Administration and 

congressional proposals that concern 

the regulatory process. The General 

Counsel’s Office works closely with 

representatives of other agencies, OMB, 

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 2011, OST will 

continue to focus its efforts on 

enhancing airline passenger protections 

by requiring carriers to adopt various 

consumer service practices (2105- 

AD92). 

OST will also continue its efforts to 

help coordinate the activities of several 

operating administrations that advance 

various departmental efforts that 

support the Administration’s initiatives 

on promoting safety; stimulating the 

economy and creating jobs; sustaining 

and building America’s transportation 

infrastructure; and improving livability 

for the people and communities who 

use transportation systems subject to the 

Department’s policies. 

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. 

It is guided by its Flight Plan goals: 

Increased Safety, Greater Capacity, 

International Leadership, and 

Organizational Excellence. It issues 

regulations to provide a safe and 

efficient global aviation system for civil 

aircraft, while being sensitive to not 

imposing undue regulatory burdens and 

costs on small businesses. 

FAA Activities that may lead to 

rulemaking in fiscal year 2011 include: 

• Promotion and expansion of safety 

information sharing efforts, such as 

FAA-industry partnerships and datadriven safety programs that prioritize 

and address risks before they lead to 

accidents. Specifically, FAA 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 decisionmaking, and 

cabin safety. Some of these projects 

may result in rulemaking and 

guidance materials. 


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• Continuing to work cooperatively to 

harmonize the U.S. aviation 

regulations with those of other 

countries, without compromising 

rigorous safety standards. 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 operators, some of 

which are small businesses. 

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. 

• In addition to the regulatory priorities 

specified below, additional priorities 

will come from the Airline Safety and 

Federal Aviation Administration 

Extension Act of 2010, signed by the 

President on August 1, 2010. 

FAA top regulatory priorities for 2010 

to 2011 include: 

• Qualification, Service, and Use of 

Crewmembers and Aircraft 

Dispatchers (2120-AJ00) 

• Helicopter Air Ambulance and 

Commercial Helicopter Safety 

Initiatives and Miscellaneous 

Amendments (2120-AJ53) 

• Flight and Duty Time Limitations and 

Rest Requirements (2120-AJ58) 

The Crewmember and Aircraft 

Dispatcher Training rulemaking would 

include proposals to: 

• Reduce human error and improve 

performance among flight 

crewmembers, flight attendants, and 

aircraft dispatchers; 

• Enhance traditional training programs 

through the use of flight simulation 

training devices for flight 

crewmembers; and 

• Include additional training in areas 

critical to safety. 

The Air Ambulance and Commercial 

Helicopter rulemaking would include 

proposals to: 

• Codify current agency guidance and 

address National Transportation 

Safety Board recommendations; 

• Provide certificate holders and pilots 

with tools and procedures that will 

aid in reducing accidents; 

• Require additional equipment on 

board helicopters or air ambulances; 

and 

• Amend all part 135 commercial 

helicopter operations regulations to 

include equipment requirements, 

pilot training, and alternate airport 

weather minimums. 

The Flight and Duty Time Limitations 

and Rest Requirements rulemaking 

would include proposals to: 

• Address fatigue mitigation and use 

existing fatigue science to establish 

minimum rest periods, flight time 

limitations, and duty period limits for 

flight crewmembers; 

• Incorporate the use of Fatigue Risk 

Management Systems as an option to 

provide operator flexibility for 

specific operations; and 

• Reduce human error attributed to 

fatigue among flight crewmembers. 

Federal Highway Administration 

(FHWA) 

The Federal Highway Administration 

(FHWA) carries out the Federal highway 

program in partnership with State and 

local agencies to meet the Nation’s 

transportation needs. The FHWA’s 

mission is to improve continually 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. 

FHWA’s top regulatory priority for the 

fiscal year is to address the remaining 

congressionally directed rulemaking 

(Real-Time System Management 

Information Program (2125-AF19)) 

resulting from the Safe, Accountable, 

Flexible, and Efficient Transportation 

Equity Act: A Legacy for Users 

(SAFETEA-LU). Additionally, the 

FHWA is in the process of reviewing all 

FHWA regulations to ensure that they 

are consistent with SAFETEA-LU and 

will update those regulations that are 

not consistent with this legislation. 

Federal Motor Carrier Safety 

Administration (FMCSA) 

The mission of the 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. FMCSA develops new 

and more effective safety regulations 

based on three core priorities: Raising 

the bar for entry, maintaining high 

standards, and removing high-risk 

behavior. In addition to Agency-directed 

regulations, FMCSA develops 

regulations mandated by Congress, such 

as the Safe, Accountable, Flexible, and 

Efficient Transportation Equity Act: A 

Legacy for Users (SAFETEA-LU). 

FMCSA regulations establish standards 

for motor carriers, drivers, vehicles, and 

State agencies receiving certain motor 

carrier safety grants and issuing 

commercial drivers’ licenses. 

FMCSA’s regulatory plan for FY 2011 

includes completion of a number of 

rulemakings that are high priorities for 

the Agency because they would have a 

positive impact on safety. Among the 

rulemakings included in the plan are: 

(1) Drivers Of Commercial Vehicles: 

Restricting The Use Of Cellular Phones 

(RIN 2126-AB29), (2) Hours of Service 

(RIN 2126-AB26), (3) Carrier Safety 

Fitness Determination (RIN 2126-AB11), 

(4) Electronic On-Board Recorders 

(EOBRs) and Hours of Service 

Supporting Documents (RIN 2126- 

AB20), and (5) National Registry of 

Certified Medical Examiners (RIN 2126- 

AA97). 

Together these priority rules could 

help to substantially improve 

commercial motor vehicle (CMV) safety 

on our Nation’s highways by improving 

FMCSA’s ability to provide safety 

oversight of motor carriers and drivers. 

For example, the Drivers of Commercial 

Vehicles: Restricting the Use of Cellular 

Phones rulemaking (RIN 2126-AB29) 

would place restrictions on mobile 

phone usage while operating a CMV. 

A major undertaking by FMCSA, 

which began in FY 2010, was to initiate 

a new rulemaking on Hours of Service 

(RIN 2126-AB26) as the result of a 

settlement agreement reached on 

October 26, 2009. Under terms of the 

settlement, FMCSA submitted a notice 

of proposed rulemaking to the Office of 

Management and Budget within 9 


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months, and must issue a final rule 

within 21 months of the settlement. 

In FY 2011, FMCSA will continue its 

work on the Comprehensive Safety 

Analysis 2010 (CSA). The CSA initiative 

will improve the way FMCSA identifies 

and conducts carrier compliance and 

enforcement operations over the coming 

years. CSA’s goal is to improve large 

truck and bus safety by assessing a 

wider range of safety performance data 

from a larger segment of the motor 

carrier industry through an array of 

progressive compliance interventions. 

FMCSA anticipates that the impacts of 

CSA and its associated rulemaking to 

put into place a new safety fitness 

standard will enable the Agency to 

prohibit ‘‘unfit’’ carriers from operating 

on the Nation’s highways (the Carrier 

Safety Fitness Determination(RIN 2126- 

AB11)) and will contribute further to the 

Agency’s overall goal of decreasing 

CMV-related fatalities and injuries. 

In FY 2011, FMCSA plans to issue a 

proposed rule on Electronic On-Board 

Recorders and Hours of Service 

Supporting Documents (RIN 2126- 

AB20) to expand the number of carriers 

required to install and operate EOBRs 

and clarify the supporting document 

requirements beyond the population 

covered by the Agency’s April 5, 2010, 

final rule. 

Also in FY 2011, FMCSA plans to 

issue a final rule on the National 

Registry of Certified Medical Examiners 

(RIN 2126-AA97) to establish training 

and testing requirements for healthcare 

professionals who issue medical 

certificates to CMV drivers. 

In order to manage its rulemaking 

agenda, FMCSA continues to involve 

senior agency leaders at the earliest 

stages of its rulemakings, and continues 

to refine its regulatory development 

process. The Agency also holds senior 

executives accountable for meeting 

deadlines for completing rulemakings. 

National Highway Traffic Safety 

Administration 

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 issue of occupant 

protection in rollover events and will 

issue a final rule establishing 

performance standards to reduce 

complete and partial ejections of vehicle 

occupants from outboard seating 

positions in fiscal year 2011. NHTSA 

will continue to work towards a final 

rule to require the installation of 

lap/shoulder belts in newly 

manufactured motorcoaches in 

accordance with NHTSA’s 2007 

Motorcoach Safety Plan and DOT’s 2009 

Departmental Motorcoach Safety Action 

Plan. NHTSA also plans to publish a 

final rule on Rearview Visibility in 

2011; this action will expand the 

required field of view to enable the 

driver of a motor vehicle to detect areas 

behind the motor vehicle to reduce 

death and injury resulting from backing 

incidents, particularly incidents 

involving small children and disabled 

persons. 

NHTSA will continue its efforts to 

reduce domestic dependency on foreign 

oil in accordance with the Energy 

Independence and Security Act (EISA) 

of 2007 by publishing in conjunction 

with EPA a joint notice of proposed 

rulemaking setting, for the first time, the 

corporate average fuel economy (CAFE) 

standards for both medium- and heavyduty trucks. NHTSA will also publish a 

notice of proposed rulemaking that 

would propose CAFE standards for light 

trucks and passenger cars for model 

years 2017 and beyond in fiscal year 

2011. 

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. To address these 

issue areas, the Agency is focusing 

especially on three strategies— 

conducting highly visible, wellpublicized 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 adopting 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) 

FRA’s current regulatory program 

contains numerous mandates resulting 

from the Rail Safety Improvement Act of 

2008 (RSIA08), as well as actions 

supporting the Department’s HighSpeed Rail Strategic Plan. RSIA08 alone 

has resulted in at least 18 rulemaking 

actions, which are competing for limited 

resources to meet statutory deadlines. 

FRA has prioritized these rulemakings 

according to the greatest effect on safety, 

as well as expressed congressional 

interest, and will work to complete as 

many rulemakings as possible prior to 

their statutory deadlines. Revised 

timelines for completion of unfinished 

regulations will be forwarded to 

Congress for consideration. 

Through the Railroad Safety Advisory 

Committee (RSAC), FRA is working to 

complete RSIA08 actions that include 

developing requirements for train 

conductor certification, roadway worker 

protection, hours of service for 

employees of intercity and commuter 

passenger rail service, and training for 

railroad employees. Specifically, with 

regard to passenger hours of service, 

FRA is developing a notice of proposed 

rulemaking that would include 

proposals to establish hours of service 

limitations for train employees of 

commuter and intercity passenger 

railroads. The regulation will also 

address fatigue issues. RSAC-supported 

actions that advance high-speed 

passenger rail include proposed 

revisions to the Track Safety Standards 

dealing with vehicle-track interaction. 

FRA is also initiating a rulemaking 

related to the development of railroad 

risk reduction and system safety 

programs. This activity will be a multiyear effort due to the underlying 

statutory requirements that must be 

undertaken prior to the issuance of any 

final rule. 

Federal Transit Administration (FTA) 

FTA helps communities support 

public transportation by making grants 

of Federal funding for transit vehicles, 

construction of transit facilities, and 


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planning and operation of transit and 

other transit-related purposes. FTA 

regulatory activity focuses 

implementing the laws that apply to 

recipients’ uses of federal funding and 

the terms and conditions of FTA grant 

awards. FTA policy regarding 

regulations is to: 

• Provide maximum benefit to the 

mobility of the nation’s citizens and 

the connectivity of transportation 

infrastructure; 

• Provide maximum local discretion; 

• Ensure the most productive use of 

limited Federal resources; 

• Protect taxpayer investments in public 

transportation; 

• Incorporate principles of sound 

management into the grant 

management process. 

As the needs for public transportation 

have changed over the years, the Federal 

transit programs have grown in number 

and complexity. FTA’s regulatory 

priorities for the coming year will reflect 

the mandates of the Agency’s 

authorization statute, including, most 

notable, the Major Capital Investments 

‘‘New Starts’’ program and the State 

Safety Oversight (SSO) program. The 

New Starts program is the main source 

of discretionary Federal funding for 

construction of rapid rail, light rail, 

commuter rail, and other forms of 

transit infrastructure. The SSO program 

addressed the safety of rapid rail 

systems and other forms of rail transit 

not otherwise regulated by the Federal 

Railroad Administration. FTA also 

anticipates amending its regulations 

governing recipients’ management of 

major capital projects and its Bus 

Testing rule. 

Maritime Administration (MARAD) 

The Maritime Administration 

(MARAD) administers Federal laws and 

programs to promote and strengthen the 

U.S. merchant marine to meet the 

economic and security needs of the 

Nation. To that end, MARAD’s efforts 

are focused upon ensuring a strong 

American presence in the domestic and 

international trades and to expanding 

maritime opportunities for American 

businesses and workers. 

MARAD’s regulatory objectives and 

priorities reflect the Agency’s 

responsibility for ensuring the 

availability of a U.S. merchant marine 

that can provide water transportation 

services for American shippers and 

consumers and, in times of war or 

national emergency, for the U.S. armed 

forces. Major program areas include: 

The Maritime Security Program; the 

Voluntary Intermodal Sealift Agreement 

program; the National Defense Reserve 

Fleet and the Ready Reserve Force; the 

Maritime Guaranteed Loan financing 

program; the United States Merchant 

Marine Academy, and mariner 

education and training support 

programs; the Deepwater Port Licensing 

program; and monitoring and 

enforcement of U.S. cargo preference 

laws. In April 2010, the Secretary 

announced MARAD’s newest program, 

the ‘‘America’s Marine Highway 

Program.’’ 

MARAD’s primary regulatory 

activities in fiscal year 2011 will be to 

assess existing cargo preference-related 

regulations, and to propose updates or 

new regulations where appropriate. 

Pipeline and Hazardous Materials 

Safety Administration (PHMSA) 

The Pipeline and Hazardous Materials 

Safety 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. 

PHMSA will continue to work toward 

the elimination of deaths and injuries 

associated with the transportation of 

hazardous materials by all 

transportation modes, including 

pipeline. We will concentrate on the 

prevention of high-risk incidents 

identified through the evaluation of 

transportation incident data and 

findings of the National Transportation 

Safety Board. PHMSA will use all 

available agency tools to assess data; 

evaluate alternative safety strategies, 

including regulatory strategies as 

necessary and appropriate; target 

enforcement efforts; and enhance 

outreach, public education, and training 

to promote safety outcomes. 

PHMSA will continue to focus its 

safety efforts on the resolution of 

highest priority risks. PHMSA will 

consider regulatory changes to combat 

the dangers practice of distracted 

driving. In an effort to understand and 

mitigate crashes associated with driver 

distraction, the DOT has been studying 

the distracted driving issue with respect 

to both behavioral and vehicle safety 

countermeasures. As part of the DOT’s 

overall strategy to this problem, PHMSA 

plans to address the practice of text 

messaging (2137-AE63) and mobile 

phone (2137-AE65) use while driving. 

PHMSA’s rules would apply to 

commercial motor vehicle drivers 

transporting a quantity of hazardous 

material requiring placarding under part 

172 of the 49 CFR or any quantity of a 

material listed as a select agent or toxin 

in 42 CFR part 73. 

PHMSA is also considering whether 

changes are needed to the regulations 

covering hazardous liquid onshore 

pipelines. In particular, PHMSA is 

considering whether it should extend 

regulation to certain pipelines currently 

exempt from regulation; whether other 

areas along a pipeline should either be 

identified for extra protection or be 

included as additional high 

consequence areas (HCAs) for Integrity 

Management (IM) protection; whether to 

establish and/or adopt standards and 

procedures for minimum lead detection 

requirements for all pipelines; whether 

to require the installation of emergency 

flow restricting devices (EFRDs) in 

certain areas; whether revised valve 

spacing requirements are needed on 

new construction or existing pipelines; 

whether repair timeframes should be 

specified for pipeline segments in areas 

outside the HCAs that are assessed as 

part of the IM; and whether to establish 

and/or adopt standards and procedures 

for improving the methods of 

preventing, detecting, assessing and 

remediating stress corrosion cracking 

(SCC) in hazardous liquid pipeline 

systems. 

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; 

• Providing multi-modal expertise in 

transportation and logistics research, 

analysis, strategic planning, systems 

engineering and training; 

• Advancement, and research and 

development, of innovative 

technologies, including intelligent 

transportation systems; 

• Comprehensive transportation 

statistics research, analysis, and 

reporting; 


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• Managing education and training in 

transportation and national 

transportation-related fields; and 

• Managing the activities of the John A. 

Volpe National Transportation 

Systems Center. 

Through its Bureau of Transportation 

Statistics, Office of Airline Information, 

RITA collects, compiles, analyzes, and 

makes accessible information on the 

Nation’s air transportation system. RITA 

collects airline financial, traffic, and 

operating statistical data, including ontime flight performance data that 

highlight long tarmac times and 

chronically late flights. This information 

gives the Government consistent and 

comprehensive economic and market 

data on airline operations that are used 

in supporting policy initiatives and 

administering the Department’s 

mandated aviation responsibilities, 

including negotiating international 

bilateral aviation agreements, awarding 

international route authorities, 

performing airline and industry status 

evaluations, supporting air service to 

small communities, setting Alaskan 

Bush Mail rates, and meeting 

international treaty obligations. 

Through its Intelligent Transportation 

Systems Joint Program Office (ITS/JPO), 

RITA conducts research and 

demonstrations and, as appropriate, 

may develop new regulations, in 

coordination with OST and other DOT 

operating administrations, to enable 

deployment of ITS research and 

technology results. This office collects 

and disseminates benefits and costs 

information resulting from ITS-related 

research along with direct measurement 

of the deployment of ITS nationwide. 

These efforts support market 

assessments for emerging market sectors 

that would be cost-prohibitive for 

industry to absorb alone. Such 

information is widely consumed by the 

community of stakeholders to determine 

their deployment needs. 

The ITS Architecture and Standards 

Programs develop and maintain a 

National ITS Architecture; develop 

open, non-proprietary interface 

standards to facilitate rapid and 

economical adoption of nationally 

interoperable ITS technologies; and 

cooperate to harmonize ITS standards 

internationally. These standards are 

incorporated into DOT operating 

administration regulatory activities 

when appropriate. 

Through its Volpe National 

Transportation Systems Center, RITA 

provides a comprehensive range of 

engineering expertise, and qualitative 

and quantitative assessment services, 

focused on applying, maintaining and 

increasing the technical body of 

knowledge to support DOT operating 

administration regulatory activities. 

Through its Transportation Safety 

Institute, RITA designs, develops, 

conducts, and evaluates training and 

technical assistance programs in 

transportation safety and security to 

support DOT operating administration 

regulatory implementation and 

enforcement activities. 

RITA’s regulatory priorities are to 

assist OST and all DOT operating 

administrations in updating existing 

regulations by applying research, 

technology, and analytical results; to 

provide reliable information to 

transportation system decisionmakers; 

and to provide safety regulation 

implementation and enforcement 

training. 

QUANTIFIABLE COSTS AND BENEFITS OF RULEMAKINGS 

ON THE 2010 to 2011 DOT REGULATORY PLAN 

(This chart does not account for non-quantifiable benefits, which are often substantial.) 

Agency/RIN 

Number 

Title Stage Quantifiable Costs 

Discounted 2007 $ 

(Millions) 

Quantifiable Benefits 

Discounted 2007 $ 

(Millions) 

OST 

2105–AD92 Enhancing Airline Passenger Protections — Part 2 FR 05/11 87.6 26.0 

Total for OST 87.6 26.0 

FAA 

2120–AJ00 Qualification, Service, and Use of Crewmembers and Aircraft Dispatchers SNPRM 01/11 TBD TBD 

2120–AJ53 Helicopter Air Ambulance and Commercial Helicopter Safety Initiatives and Miscellaneous Amendments FR 10/11 TBD TBD 

2120–AJ58 Flight and Duty Time Limitations and Rest Requirements FR 07/11 TBD TBD 

Total for FAA 0 0 

FMCSA 

2126–AA97 National Registry of Certified Medical Examiners FR 4/11 587 1,034 

2126–AB11 Carrier Safety Fitness Determination NPRM 4/11 TBD TBD 

2126–AB20 Electronic On–Board Recorders and Hours of service Supporting 

Documents 

TBD TBD TBD 

2126–AB26 Hours of Service NPRM 11/10 TBD TBD 

2126–AB29 Drivers of Commercial Vehicles: Restricting the Use Of Cellular 

Phones 

NPRM 12/10 TBD TBD 


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Agency/RIN 

Number Title Stage Quantifiable Costs 

Discounted 2007 $ 

(Millions) 

Quantifiable Benefits 

Discounted 2007 $ 

(Millions) 

Total for FMCSA 587 1,034 

NHTSA 

2127–AK23 Ejection Mitigation FR 01/11 583 1,741 – 2,188 

2127–AK43 Rearview Mirrors NPRM 12/10 1,861 – 1,933 619 – 778 

2127–AK74 Heavy Duty Truck Fuel Economy Emissions NPRM 12/10 7,753 49,340 

2127–AK79 Passenger Car and Light Truck Corporate Average Fuel Economy 

Standards MYs 2017 and Beyond 

Supplemental 

Notice of Intent 

12/10 

TBD TBD 

Total for NHTSA 10,197 – 

10,269 

51,700 – 

52,306 

FRA 

2130–AC15 Hours of Service: Passenger Train Employees NPRM 05/11 TBD TBD 

Total for FRA 0 0 

FTA 

2132–AB02 Major Capital Investment Projects NPRM 06/11 TBD TBD 

Total for FRA 0 0 

PHMSA 

2137–AE63 Hazardous Materials: Limiting the Use of Electronic Devices by 

Highway 

FR 03/11 TBD TBD 

2137–AE65 Hazardous Materials: Limiting the Use of Mobile Telephones by 

Highway 

NPRM 01/11 TBD TBD 

Total for PHMSA 0 0 

TOTAL FOR DOT 10,871.6 – 

10,943.6 

52,760 – 

53,366 

Notes: 

Costs and benefits discounted at a 7 percent discount rate over the lifetime of the model years involved (5 model years for fuel economy, 1 model year for the other standards). 

Costs and benefits of rulemakings may be forecast over varying periods. Although the forecast periods will be the same for any given rulemaking, comparisons between proceedings 

should be made cautiously. 

The Department of Transportation generally assumes that there are economic benefits to avoiding a fatality of $6 million. That economic value is included as part of the benefits estimates shown in the chart. As noted above, we have not included the non-quantifiable benefits. 

DOT—Office of the Secretary (OST) 

FINAL RULE STAGE 

113. ŒENHANCING AIRLINE 

PASSENGER PROTECTIONS—PART 2 

Priority: 

Other Significant 

Legal Authority: 

49 USC 41712; 49 USC 40101; 49 USC 

41702 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

This rulemaking would enhance airline 

passenger protections by addressing the 

following areas: (1) Contingency plans 

for lengthy tarmac delays; (2) reporting 

of tarmac delay data; (3) customer 

service plans; (4) notification to 

passengers of flight status changes; (5) 

inflation adjustment for denied 

boarding compensation; (6) alternative 

transportation for passengers on 

canceled flights; (7) opt-out provisions 

(e.g. travel insurance); (8) contract of 

carriage provisions; (9) baggage fees 

disclosure; and (10) full fare 

advertising. 

Statement of Need: 

This rule is needed to improve the air 

travel environment for passengers. 

Summary of Legal Basis: 

The Department has authority and 

responsibility under 49 U.S.C. 41712, 

in concert with 49 U.S.C. 40101 and 

49 U.S.C. 41702, to protect consumers 

from unfair and deceptive practices and 

to ensure safe and adequate service in 

air transportation. 

Alternatives: 

The main alternative would be to take 

no regulatory action. 

Anticipated Cost and Benefits: 

To be determined. 

Risks: 

The risk of not taking regulatory action 

would be a continuation of the 

dissatisfaction and frustration 

passengers have with the air travel 

environment. 


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Timetable: 

Action Date FR Cite 

NPRM 06/08/10 75 FR 32318 

Clarification to NPRM 06/25/10 75 FR 36300 

NPRM Comment 

Period Extended 

08/03/10 75 FR 45562 

NPRM Comment 

Period End 

08/09/10 

Extended Comment 

Period End 

09/23/10 

Final Rule 04/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Undetermined 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Blane A. Workie 

Attorney 

Department of Transportation 

Office of the Secretary 

1200 New Jersey Avenue SE 

Washington, DC 20590 

Phone: 202 366–9342 

TDD Phone: 202 755–7687 

Fax: 202 366–7152 

Email: blane.workie@ost.dot.gov 

Related RIN: Related to 2105–AD72 

RIN: 2105–AD92 

DOT—Federal Aviation Administration 

(FAA) 

PROPOSED RULE STAGE 

114. ŒQUALIFICATION, SERVICE, AND 

USE OF CREWMEMBERS AND 

AIRCRAFT DISPATCHERS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

49 USC 106(g); 49 USC 40113; 49 USC 

40119; 49 USC 44101; 49 USC 44701; 

49 USC 44702; 49 USC 44705; 49 USC 

44709 to 44711; 49 USC 44713; 49 USC 

44716; 49 USC 44717; 49 USC 44722; 

49 USC 44901; 49 USC 44903; 49 USC 

44904; 49 USC 44912; 49 USC 46105 

CFR Citation: 

14 CFR 119; 14 CFR 121; 14 CFR 135; 

14 CFR 142; 14 CFR 65 

Legal Deadline: 

None 

Abstract: 

This rulemaking would amend the 

regulations for crewmember and 

dispatcher training programs in 

domestic, flag, and supplemental 

operations. The rulemaking would 

enhance traditional training programs 

by requiring the use of flight simulation 

training devices for flight crewmembers 

and including additional training 

requirements in areas that are critical 

to safety. The rulemaking would also 

reorganize and revise the qualification 

and training requirements. The changes 

are intended to contribute significantly 

to reducing aviation accidents. 

Statement of Need: 

This rulemaking is part of the FAA’s 

efforts to reduce fatal accidents in 

which human error was a major 

contributing cause. The changes would 

reduce human error and improve 

performance among flight 

crewmembers, flight attendants, and 

aircraft dispatchers. National 

Transportation Safety Board (NTSB) 

investigations identified several areas of 

inadequate training that were the 

probable cause of an accident. This 

rulemaking contains changes to address 

the causes and factors identified by the 

NTSB. 

Summary of Legal Basis: 

The FAA’s authority to issue rules on 

aviation safety is found in title 49 of 

the United States Code. This 

rulemaking is promulgated under the 

authority described in 49 U.S.C. 

44701(a)(5), which requires the 

Administrator to promulgate 

regulations and minimum standards for 

other practices, methods, and 

procedures necessary for safety in air 

commerce and national security. 

Alternatives: 

During the Notice of Proposed 

Rulemaking (NPRM) phase, the FAA 

did not find any significant alternatives 

in accordance with 5 U.S.C. section 

603(d). The FAA will again review 

alternatives at the final rule phase. 

Anticipated Cost and Benefits: 

The FAA is developing the costs and 

benefits of this rulemaking. 

Risks: 

The FAA will review specific risks 

associated with this rulemaking. 

Timetable: 

Action Date FR Cite 

NPRM 01/12/09 74 FR 1280 

Notice of public 

meeting 

03/12/09 74 FR 10689 

NPRM Comment 

Period Extended 

04/20/09 74 FR 17910 

NPRM Comment 

Period End 

05/12/09 

NPRM Extended 

Comment Period 

End 

08/10/09 

Supplemental NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Additional Information: 

For flight crewmember information 

contact Edward Cook, for flight 

attendant information contact Nancy 

Lauck Claussen, and for aircraft 

dispatcher information contact Leo 

Hollis, Air Carrier Training Branch 

(AFS-210), Flight Standards Service, 

Federal Aviation Administration, 800 

Independence Avenue SW., 

Washington, DC 20591; telephone (202) 

267 8166. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Nancy L Claussen 

Department of Transportation 

Federal Aviation Administration 

800 Independence Avenue SW 

Washington, DC 20591 

Phone: 202 267–8166 

Email: nancy.claussen@faa.gov 

RIN: 2120–AJ00 

DOT—FAA 

115. ŒAIR AMBULANCE AND 

COMMERCIAL HELICOPTER 

OPERATIONS; SAFETY INITIATIVES 

AND MISCELLANEOUS AMENDMENTS 

Priority: 

Other Significant 


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Legal Authority: 

49 USC 106(g); 49 USC 1155; 49 USC 

40101 to 40103; 49 USC 40120; 49 USC 

41706; 49 USC 41721; 49 USC 44101; 

49 USC 44106; 49 USC 44111; 49 USC 

46306; 49 USC 46315; 49 USC 46316; 

49 USC 46504; 49 USC 46506; 49 USC 

46507; 49 USC 47122; 49 USC 47508; 

49 USC 47528 to 47531 

CFR Citation: 

14 CFR 1; 14 CFR 135 

Legal Deadline: 

None 

Abstract: 

This rulemaking would change 

equipment and operating requirements 

for commercial helicopter operations, 

including many specifically for 

helicopter air ambulance operations. 

This rulemaking is necessary to 

increase crew, passenger, and patient 

safety. The intended effect is to 

implement the National Transportation 

Safety Board, Aviation Rulemaking 

Committee, and internal FAA 

recommendations. 

Statement of Need: 

Since 2002, there has been an increase 

in fatal helicopter air ambulance 

accidents. The FAA has undertaken 

initiatives to address common factors 

that contribute to helicopter air 

ambulance accidents including issuing 

notices, handbook bulletins, operations 

specifications, and advisory circulars 

(ACs). This rule would codify many of 

those initiatives, as well as several 

NTSB and part 125/135 Aviation 

Rulemaking Committee 

recommendations. In addition, the 

House of Representatives and the 

Senate introduced legislation in the 

111th Congress and in earlier sessions 

that would address several of the issues 

raised in this rulemaking. 

Summary of Legal Basis: 

This rulemaking is promulgated under 

the authority described in 49 U.S.C. 

44701(a)(4), which requires the 

Administrator to promulgate 

regulations in the interest of safety for 

the maximum hours or periods of 

service of airmen and other employees 

of air carriers, and 49 U.S.C. 

44701(a)(5), which requires the 

Administrator to promulgate 

regulations and minimum standards for 

other practices, methods, and 

procedures necessary for safety in air 

commerce and national security. 

Alternatives: 

Alternative One: The alternative would 

change the compliance date from three 

years to four years after the effective 

rule date to install all required pieces 

of equipment. This would help small 

business owners cope with the burden 

of the expenses because they would be 

able to integrate these pieces of 

equipment over a longer period of time. 

This alternative is not preferred 

because it would delay safety 

enhancements. 

Alternative Two: The alternative would 

exclude the HTAWS unit from this 

proposal. Although this alternative 

would reduce annualized costs to small 

air ambulance operators by 

approximately 12 percent and the ratio 

of annualized cost to annual revenue 

would decrease from a range of 

between 1.76 percent and 1.88 percent 

to a range of between 1.55 percent and 

1.65 percent, the annualized cost would 

still be significant for all 35 small air 

ambulance operators. The alternative 

not only does not eliminate the 

problem for a substantial number of 

small entities, but also would reduce 

safety. The HTAWS is an outstanding 

tool for situational awareness in all 

aspects of flying including day, night, 

and instrument meteorological 

conditions. Therefore the FAA believes 

that this equipment is a significant 

enhancement for safety. 

Alternative Three: The alternative 

would increase the requirement of 

certificate holders from 10 to 15 

helicopters or more that are engaged in 

helicopter air ambulance operations to 

have an Operations Control Center. The 

FAA believes that operators with 10 or 

more helicopters engaged in air 

ambulance operations would cover 66 

percent of the total population of the 

air ambulance fleet in the U.S. The 

FAA believes that operators with 15 or 

more helicopters would decrease the 

coverage of the population to 50 

percent. Furthermore, complexity 

issues arise and considerably increase 

with operators of more than 10 

helicopters. 

All alternatives above are not 

considered to be acceptable by the FAA 

in accordance with 5 U.S.C. 603(c). 

Anticipated Cost and Benefits: 

The FAA is currently developing costs 

and benefits. 

Risks: 

Helicopter air ambulance operations 

have several characteristics that make 

them unique, including that they are 

not limited to airport locations for 

picking up and dropping off patients, 

but may pick up a person at a roadside 

accident scene and transport him or her 

directly to a hospital. Helicopter air 

ambulance operations are also often 

time-sensitive. A helicopter air 

ambulance flight may be crucial to 

getting a donor organ or critically ill 

or injured patient to a medical facility 

as efficiently as possible. Additionally, 

patients generally are not able to 

choose the helicopter air ambulance 

company that provides them with 

transportation. Despite the fact that 

there are unique aspects to helicopter 

air ambulance operations, they remain, 

at their core, air transportation. 

Accordingly, the FAA has the 

responsibility for ensuring the safety of 

these operations. 

Timetable: 

Action Date FR Cite 

NPRM 10/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Lawrence Buehler 

Flight Standards Service 

Department of Transportation 

Federal Aviation Administration 

800 Independence Avenue SW. 

Washington, DC 20591 

Phone: 202 267–8452 

RIN: 2120–AJ53 

DOT—FAA 

FINAL RULE STAGE 

116. ŒFLIGHT AND DUTY TIME 

LIMITATIONS AND REST 

REQUIREMENTS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

49 USC 106(g); 49 USC 40113; 49 USC 

40119; 49 USC 41706; 49 USC 44101; 


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49 USC 44701; 49 USC 44702; 49 USC 

44705; 49 USC 44705; 49 USC 44709; 

49 USC 44710; 49 USC 44711; 49 USC 

44712; 49 USC 44713; 49 USC 44715; 

49 USC 44716; 49 USC 44717; 49 USC 

44722; 49 USC 45101; 49 USC 45102; 

49 USC 45103; 49 USC 45104; 49 USC 

45105; 49 USC 46105 

CFR Citation: 

14 CFR 121; 14 CFR 135 

Legal Deadline: 

None 

Abstract: 

This rulemaking would establish one 

set of flight time limitations, duty 

period limits, and rest requirements for 

pilots. The rulemaking is necessary to 

ensure that pilots have the opportunity 

to obtain sufficient rest to perform their 

duties. The objective of the rule is to 

contribute to and to improve aviation 

safety. This rulemaking is related to the 

following: An NPRM (RIN 2120-AF63), 

and a Withdrawal (RIN 2120-AI93). 

Statement of Need: 

The FAA recognizes that the effects of 

pilot fatigue are universal, and the 

profiles of different types of operations 

are similar enough that the same fatigue 

mitigations should be applied across all 

types of operations. 

In June 2009, the FAA established the 

Flight and Duty Time Limitations and 

Rest Requirements Aviation 

Rulemaking Committee (ARC) whose 

membership includes labor, industry, 

and FAA representatives. The ARC 

reviewed current approaches to 

mitigating fatigue and in September 

2009 made recommendations to the 

Associate Administrator for Aviation 

Safety on how to address this issue in 

FAA regulations. 

The ARC considered: 

* An approach to fatigue that 

consolidates and replaces existing 

regulatory requirements; 

* Current fatigue science, data, and 

information; 

* How current international standards 

address fatigue; and 

* The use of Fatigue Risk Management 

Systems. 

Based on ARC recommendations, the 

FAA is developing new regulations on 

crewmember flight, duty and rest 

requirements. 

Summary of Legal Basis: 

The FAA’s authority to issue rules on 

aviation safety is found in title 49 of 

the United States Code. This 

rulemaking is promulgated under the 

authority described in 49 U.S.C. 

44701(a)(5), which requires the 

Administrator to promulgate 

regulations and minimum standards for 

other practices, methods, and 

procedures necessary for safety in air 

commerce and national security. 

Alternatives: 

The FAA is currently reviewing 

alternatives to rulemaking. 

Anticipated Cost and Benefits: 

The proposed rule is designated as 

‘‘significant regulatory action’’ as 

designated in section 3(f) of Executive 

Order 12866. In addition, the proposed 

rule would have a significant economic 

impact on a substantial number of 

small entities. Quantifiable costs and 

benefits to be determined. 

Risks: 

The FAA will review specific risks 

associated with this rulemaking. 

Timetable: 

Action Date FR Cite 

NPRM 09/14/10 75 55852 

NPRM Comment 

Period End 

11/15/10 

Final Action 07/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Organizations 

Government Levels Affected: 

None 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Nancy L Claussen 

Department of Transportation 

Federal Aviation Administration 

800 Independence Avenue SW 

Washington, DC 20591 

Phone: 202 267–8166 

Email: nancy.claussen@faa.gov 

Related RIN: Related to 2120–AF63, 

Related to 2120–AI93 

RIN: 2120–AJ58 

DOT—Federal Motor Carrier Safety 

Administration (FMCSA) 

PROPOSED RULE STAGE 

117. ŒCARRIER SAFETY FITNESS 

DETERMINATION 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

sec 4009 of TEA–21 

CFR Citation: 

49 CFR 385 

Legal Deadline: 

None 

Abstract: 

This rulemaking would revise 49 CFR 

part 385, Safety Fitness Procedures, in 

accordance with the Agency’s major 

new initiative, Comprehensive Safety 

Analysis (CSA) 2010. CSA 2010 is a 

new operational model FMCSA plans 

to implement that is designed to help 

the Agency carry out its compliance 

and enforcement programs more 

efficiently and effectively. Currently, 

the safety fitness rating of a motor 

carrier is determined based on the 

results of a very labor intensive 

compliance review conducted at the 

carrier’s place of business. Aside from 

roadside inspections and new audits, 

the compliance review is the Agency’s 

primary intervention. Under CSA 2010, 

FMCSA would propose to implement 

a broader array of progressive 

interventions, some of which allow 

FMCSA to make contact with more 

carriers. Through this rulemaking 

FMCSA would establish safety fitness 

determinations based on safety data 

consisting of crashes, inspections, and 

violation history rather than the 

standard compliance review. This will 

enable the Agency to assess the safety 

performance of a greater segment of the 

motor carrier industry with the goal of 

further reducing large truck and bus 

crashes and fatalities. 

Statement of Need: 

Because of the time and expense 

associated with the on-site compliance 

review, only a small fraction of carriers 

(approximately 12,000) receive a safety 

fitness determination each year. Since 

the current safety fitness determination 


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process is based exclusively on the 

results of an on site compliance review, 

the great majority of carriers subject to 

FMCSA jurisdiction do not receive a 

timely determination of their safety 

fitness. 

The proposed methodology for 

determining motor carrier safety fitness 

should correct the deficiencies of the 

current process. In correcting these 

deficiencies, FMCSA has made a 

concerted effort to develop a 

‘‘transparent’’ method for the SFD that 

would allow each motor carrier to 

understand fully how FMCSA 

established that carrier’s specific SFD. 

Summary of Legal Basis: 

This rule is based primarily on the 

authority of 49 U.S.C. 31144, which 

directs the Secretary of Transportation 

to ‘‘determine whether an owner or 

operator is fit to operate a commercial 

motor vehicle’’ and to ‘‘maintain by 

regulation a procedure for determining 

the safety fitness of an owner or 

operator.’’ This statute was first enacted 

as part of the Motor Carrier Safety Act 

of 1984, section 215, Public Law 98- 

554, 98 Stat. 2844 (Oct. 30, 1984). 

The proposed rule also relies on the 

provisions of 49 U.S.C. 31133, which 

gives the Secretary ‘‘broad 

administrative powers to assist in the 

implementation’’ of the provisions of 

the Motor Carrier Safety Act now found 

in chapter 311 of title 49, U.S.C. These 

powers include, among others, 

authority to conduct inspections and 

investigations, compile statistics, 

require production of records and 

property, prescribe recordkeeping and 

reporting requirements and to perform 

other acts considered appropriate. 

These powers are used to obtain the 

data used by the Safety Management 

System and by the proposed new 

methodology for safety fitness 

determinations. 

Under 49 CFR 1.73(g), the Secretary has 

delegated the authority to carry out the 

functions in subchapters I, III, and IV 

of chapter 311, title 49, U.S.C., to the 

FMCSA Administrator. Sections 31133 

and 31144 are part of subchapter III of 

chapter 311. 

Alternatives: 

The Agency has been considering only 

two alternatives: The no-action 

alternative and the proposal. 

Anticipated Cost and Benefits: 

The Agency continues to estimate the 

crash-reduction benefit at this time. 

Risks: 

A risk of incorrectly identifying a 

compliant carrier as non-compliant— 

and consequently subjecting the carrier 

to unnecessary expenses—has been 

analyzed and has been found to be 

negligible under the process being 

proposed. 

Timetable: 

Action Date FR Cite 

NPRM 05/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Jim Keenan 

Office of Compliance and Enforcement 

Department of Transportation 

Federal Motor Carrier Safety 

Administration 

1200 New Jersey Avenue SE. 

Washington, DC 20590 

Phone: 202 366–2096 

Email: fmcsaregs@dot.gov 

RIN: 2126–AB11 

DOT—FMCSA 

118. ŒELECTRONIC ON–BOARD 

RECORDERS AND HOURS OF 

SERVICE SUPPORTING DOCUMENTS 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

49 USC 31502; 31136(a); PL 103.311; 

49 USC 31137(a) 

CFR Citation: 

49 CFR 350; 49 CFR 385; 49 CFR 396; 

49 CFR 395 

Legal Deadline: 

None 

Abstract: 

This rulemaking will consider revisions 

to RIN 2126-AA89 (Electronic On-Board 

Recorders for Hours of Service Drivers) 

to expand the number of motor carriers 

required to install and operate 

Electronic On-Board Recorders 

(EOBRs). FMCSA is consolidating this 

follow-up to the EOBR rule with the 

Hours Of Service Of Drivers: 

Supporting Documents rulemaking for 

development of a single NPRM in RIN 

2126-AB20. In addressing Hours of 

Service Supporting Documents 

requirements in this new rulemaking, 

FMCSA will consider reducing or 

eliminating current paperwork burdens 

associated with supporting documents 

in favor of expanded EOBR use. On 

January 15, 2010, the American 

Trucking Associations (ATA) filed a 

Petition for a Writ of Mandamus in the 

United States Court of Appeals for the 

District of Columbia Circuit (D.C. Cir. 

No. 10-1009). ATA petitioned the court 

to direct FMCSA to issue an NPRM on 

‘‘supporting documents’’ in 

conformance with the requirements set 

forth in section 113 of mandamus on 

September 30, 2010, ordering FMCSA 

to issue an NPRM on the supporting 

document regulations by December 30, 

2010. 

Statement of Need: 

This rulemaking proposes to improve 

safety on the Nation’s highways by 

increasing compliance with the Hours 

of Service regulations. This rulemaking 

proposes to require the use of 

Electronic On-Board Recorders by an 

expanded population, and to clarify 

and specify requirements related to 

supporting documents. 

Summary of Legal Basis: 

Section 31502 of title 49 of the United 

States Code provides that ‘‘[t]he 

Secretary of Transportation may 

prescribe requirements for: (1) 

Qualifications and maximum hours of 

service of employees of, and safety of 

operation and equipment of, a motor 

carrier; and (2) qualifications and 

maximum hours of service of 

employees of, and standards of 

equipment of, a motor private carrier, 

when needed to promote safety of 

operation.’’ This rulemaking addresses 

‘‘safety of operation and equipment’’ of 

motor carriers and ‘‘standards of 

equipment’’ of motor private carriers 

and, as such, is well within the 

authority of 49 U.S.C. 31502. The 

rulemaking would allow motor carriers 

to use EOBRs to document drivers? 

compliance with the HOS 

requirements; require some 


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noncompliant carriers to install, use, 

and maintain EOBRs for this purpose; 

and update existing performance 

standards for on-board recording 

devices. 

Section 31136 of title 49 of the United 

States Code provides concurrent 

authority to regulate drivers, motor 

carriers, and vehicle equipment. It 

requires the Secretary to ‘‘prescribe 

regulations on commercial motor 

vehicle safety. The regulations shall 

prescribe minimum safety standards for 

commercial motor vehicles. At a 

minimum, the regulations shall ensure 

that: (1) Commercial motor vehicles are 

maintained, equipped, loaded, and 

operated safely; (2) the responsibilities 

imposed on operators of commercial 

motor vehicles do not impair their 

ability to operate the vehicles safely; 

(3) the physical condition of operators 

of commercial motor vehicles is 

adequate to enable them to operate the 

vehicles safely; and (4) the operation 

of commercial motor vehicles does not 

have a deleterious effect on the 

physical condition of the operators.‘‘ 

Alternatives: 

To be determined. 

Anticipated Cost and Benefits: 

FMCSA has not yet fully assessed the 

costs and benefits that might be 

associated with this activity. 

Risks: 

FMCSA has not yet fully assessed the 

risks that might be associated with this 

activity. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Small Entities Affected: 

Businesses, Governmental Jurisdictions, 

Organizations 

Government Levels Affected: 

None 

Additional Information: 

The Agency previously published an 

NPRM on this subject under RIN 2126- 

AA76, ‘‘Hours of Service of Drivers; 

Supporting Documents’’ (63 FR 19457, 

Apr. 20, 1998) and an SNPRM, ‘‘Hours 

of Service of Drivers; Supporting 

Documents’’ (69 FR 63997, Nov. 3, 

2004). The Agency withdrew the 

SNPRM on October 25, 2007, 72 FR 

60614. The previous proceeding can be 

found in docket No. FMCSA-1998-3706. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Deborah M. Freund 

Senior Transportation Specialist 

Department of Transportation 

Federal Motor Carrier Safety 

Administration 

1200 New Jersey Avenue SE. 

Washington, DC 20590 

Phone: 202 366–5370 

Email: deborah.freund@dot.gov 

Related RIN: Related to 2126–AA89, 

Related to 2126–AA76 

RIN: 2126–AB20 

DOT—FMCSA 

119. ŒHOURS OF SERVICE 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

49 USC 31502(b) 

CFR Citation: 

49 CFR 395 

Legal Deadline: 

NPRM, Judicial, July 26, 2010, NPRM 

to OMB. 

Final, Judicial, July 26, 2011. 

Abstract: 

On October 26, 2009, Public Citizen, 

et al. (Petitioners), and FMCSA entered 

into a settlement agreement under 

which Petitioners’ petition for judicial 

review of the November 19, 2008, Final 

Rule on drivers’ hours of service will 

be held in abeyance pending the 

publication of an NPRM reevaluating 

the Hours of Service rule. 

Statement of Need: 

The goals of this hours of service (HOS) 

proposed rule are to improve safety 

while ensuring that the requirements 

would not have an adverse impact on 

driver health. The proposed rule would 

also provide drivers with the flexibility 

to obtain rest when they need it and 

to adjust their schedules to account for 

unanticipated delays. FMCSA has also 

attempted to make the proposed rule 

easy to understand (though not at the 

expense of safety) and readily 

enforceable. The impact of HOS rules 

on commercial motor vehicle (CMV) 

safety is difficult to separate from the 

many other factors that affect heavyvehicle crashes. The 2008 FMCSA final 

rule on HOS noted that ‘‘FMCSA has 

consistently been cautious about 

inferring causal relationships between 

the HOS requirements and trends in 

overall motor carrier safety. The 

Agency believes that the data show no 

decline in highway safety since the 

implementation of the 2003 rule and 

its re-adoption in the 2005 rule and the 

2007 [interim final rule]’’ (73 FR 69567, 

69572, November 19, 2008). While that 

statement remains correct, the total 

number of crashes, though declining, is 

still unacceptably high. FMCSA 

believes that the modified HOS rules 

proposed, coupled with the Agency’s 

many other safety initiatives and 

assisted by the actions of an 

increasingly safety-conscious motor 

carrier industry, would result in 

continued reductions in fatigue-related 

CMV crashes and fatalities. 

Furthermore, this proposed rule is 

intended to protect drivers from the 

serious health problems associated with 

excessively long work hours, without 

significantly compromising their ability 

to do their jobs and earn a living. 

Summary of Legal Basis: 

The HOS regulations proposed today 

concern the ‘‘maximum hours of 

service of employees of . . . a motor 

carrier’’ (49 U.S.C. 31502(b)(1)) and the 

‘‘maximum hours of service of 

employees of . . . a motor private 

carrier’’ (49 U.S.C. 31502(b)(2)). The 

adoption and enforcement of such rules 

were specifically authorized by the 

Motor Carrier Act of 1935. 

The 1984 Act provides concurrent 

authority to regulate drivers, motor 

carriers, and vehicle equipment. It 

requires the Secretary of Transportation 

to ‘‘prescribe regulations on commercial 

motor vehicle safety. The regulations 

shall prescribe minimum safety 

standards for commercial motor 

vehicles.’’ Although this authority is 

very broad, the 1984 Act also includes 

specific requirements: ‘‘At a minimum, 

the regulations shall ensure that (1) 

commercial motor vehicles are 

maintained, equipped, loaded, and 

operated safely; (2) the responsibilities 

imposed on operators of commercial 

motor vehicles do not impair their 

ability to operate the vehicles safely; 

(3) the physical condition of operators 

of commercial motor vehicles is 

adequate to enable them to operate the 

vehicles safely; and (4) the operation 

of commercial motor vehicles does not 

have a deleterious effect on the 


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physical condition of the operators‘‘ (49 

U.S.C. 31136(a)). 

Alternatives: 

FMCSA considered and assessed the 

consequences of four potential 

regulatory options. Option 1 is the noaction alternative, which would leave 

the existing rule in place. Options 2, 

3, and 4 each would adopt several 

revisions to the rule. 

Anticipated Cost and Benefits: 

The Agency’s analysis shows an 

annualized cost for the various 

alternatives of about $1 billion, with 

against annual safety and health 

benefits estimated to range from below 

$300 million to more than $2 billion 

under different assumptions. 

Risks: 

The level of fatigue involvement in 

truck crashes is uncertain. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Organizations 

Government Levels Affected: 

None 

Additional Information: 

Docket FMCSA-2004-19608 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Thomas Yager 

Driver and Carrier Operations Division 

Department of Transportation 

Federal Motor Carrier Safety 

Administration 

1200 New Jersey Avenue SE. 

Washington, DC 20590 

Phone: 202 366–4325 

Email: tom.yager@dot.gov 

RIN: 2126–AB26 

DOT—FMCSA 

120. ŒDRIVERS OF COMMERCIAL 

VEHICLES: RESTRICTING THE USE 

OF CELLULAR PHONES (SECTION 

610 REVIEW) 

Priority: 

Other Significant 

Legal Authority: 

PL 98–554 

CFR Citation: 

49 CFR 383; 49 CFR 384; 49 CFR 390; 

49 CFR 391; 49 CFR 392 

Legal Deadline: 

None 

Abstract: 

This rulemaking would restrict the use 

of mobile telephones while operating a 

commercial motor vehicle. This 

rulemaking is in response to Federal 

Motor Carrier Safety Administrationsponsored studies that analyzed safety 

incidents and distracted drivers. This 

rulemaking addresses an item on the 

National Transportation Safety Board’s 

‘‘Most Wanted List’’ of safety 

recommendations. 

Statement of Need: 

This rulemaking stems from the 

Distracted Driver Summit on September 

30 and October 1, 2009. This proposed 

rule would restrict the use of mobile 

telephones by all commercial motor 

vehicle drivers (CMV). This NPRM 

addresses the NTSB ‘‘most wanted’’ 

item associated with a 2004 crash in 

Alexandria, Virginia. Furthermore, it 

would addresses recent crashes in 

Kentucky and North Carolina that 

according to media reports may have 

involved cell phone use. This 

rulemaking would improve safety on 

the Nation’s highways by reducing the 

prevalence of distracted driving-related 

crashes, fatalities, and injuries 

involving drivers of CMVs. 

Summary of Legal Basis: 

Motor Carrier Safety Act of 1984 (1984 

Act), 49 U.S.C. chapter 311, and the 

Commercial Motor Vehicle Safety Act 

of 1986 (1986 Act), 49 U.S.C. chapter 

313. 

Alternatives: 

FMCSA considered several options for 

restricting mobile telephone use and 

provided analysis of their safety and 

economic or environmental impacts. 

Anticipated Cost and Benefits: 

The Agency is currently finalizing 

several options to provide an accurate 

statement of costs and benefits. 

Risks: 

FMCSA is continuing its analysis of the 

risk that might be associated with 

mobile telephone use. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Mike Huntley 

Chief, Vehicle and Roadside Operations 

Division 

Department of Transportation 

Federal Motor Carrier Safety 

Administration 

1200 New Jersey Avenue SE. 

Washington, DC 20590 

Phone: 202 366–9209 

Email: michael.huntley@dot.gov 

Related RIN: Related to 2126–AB22 

RIN: 2126–AB29 

DOT—FMCSA 

FINAL RULE STAGE 

121. ŒNATIONAL REGISTRY OF 

CERTIFIED MEDICAL EXAMINERS 

Priority: 

Other Significant. Major under 5 USC 

801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

PL 109–59 (2005), sec 4116 

CFR Citation: 

49 CFR 390; 49 CFR 391 

Legal Deadline: 

Final, Statutory, August 10, 2006. 

Abstract: 

This rulemaking would establish 

training, testing and certification 


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standards for medical examiners 

responsible for certifying that interstate 

commercial motor vehicle drivers meet 

established physical qualifications 

standards; provide a database (or 

National Registry) of medical examiners 

that meet the prescribed standards for 

use by motor carriers, drivers, and 

Federal and State enforcement 

personnel in determining whether a 

medical examiner is qualified to 

conduct examinations of interstate 

truck and bus drivers; and require 

medical examiners to transmit 

electronically to FMCSA the name of 

the driver and a numerical identifier 

for each driver that is examined. The 

rulemaking would also establish the 

process by which medical examiners 

that fail to meet or maintain the 

minimum standards would be removed 

from the National Registry. This action 

is in response to section 4116 of Safe, 

Accountable, Flexible, Efficient, 

Transportation Equity Act: A Legacy for 

Users. 

Statement of Need: 

In enacting the Safe, Accountable, 

Flexible, Efficient Transportation 

Equity Act: A Legacy for Users 

(SAFETEA-LU) [Pub. L. 109-59, August 

10, 2005], Congress recognized the need 

to improve the quality of the medical 

certification of drivers. SAFETEA-LU 

addresses the requirement for medical 

examiners to receive training in 

physical examination standards and be 

listed on a national registry of medical 

examiners as one step toward 

improving the quality of the 

commercial motor vehicle (CMV) driver 

physical examination process and the 

medical fitness of CMV drivers to 

operate CMVs. The safety impact will 

result from ensuring that medical 

examiners have completed training and 

testing to demonstrate that they fully 

understand FMCSA’s physical 

qualifications standards and are capable 

of applying those standards 

consistently, thereby decreasing the 

likelihood that a medically unqualified 

driver may obtain a medical certificate. 

Summary of Legal Basis: 

The fundamental legal basis for the 

NRCME program comes from 49 U.S.C. 

31149(d), which requires FMCSA to 

establish and maintain a current 

national registry of medical examiners 

that are qualified to perform 

examinations of CMV drivers and to 

issue medical certificates. FMCSA is 

required to remove from the registry 

any medical examiner who fails to meet 

or maintain qualifications established 

by FMCSA. In addition, in developing 

its regulations, FMCSA must consider 

both the effect of driver health on the 

safety of CMV operations and the effect 

of such operations on driver health, 49 

U.S.C. 31136(a). 

Alternatives: 

The rulemaking is statutorily mandated. 

Thus, the Agency must establish the 

National Registry. 

Anticipated Cost and Benefits: 

FMCSA continues to finalize the costs 

and benefits associated with this 

rulemaking based on comments 

received to the NPRM. 

Risks: 

FMCSA has not yet fully assessed the 

risks that might be associated with this 

activity. 

Timetable: 

Action Date FR Cite 

NPRM 12/01/08 73 FR 73129 

NPRM Comment 

Period End 

01/30/09 

Final Rule 07/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Dr. Mary D. Gunnels 

Director, Office of Medical Programs 

Department of Transportation 

Federal Motor Carrier Safety 

Administration 

1200 New Jersey Avenue SE. 

Washington, DC 20590 

Phone: 202 366–4001 

Email: maggi.gunnels@dot.gov 

RIN: 2126–AA97 

DOT—National Highway Traffic Safety 

Administration (NHTSA) 

PRERULE STAGE 

122. ∑ ŒPASSENGER CAR AND LIGHT 

TRUCK CORPORATE AVERAGE FUEL 

ECONOMY STANDARDS MYS 2017 

AND BEYOND 

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 32902; delegation of authority 

at 49 CFR 1.50 

CFR Citation: 

49 CFR 533 

Legal Deadline: 

Final, Statutory, April 1, 2015. 

Abstract: 

This rulemaking would establish 

Corporate Average Fuel Economy 

(CAFE) standards for light trucks and 

passenger cars for model years 2017 

and beyond. This rulemaking would 

respond to requirements of the Energy 

Policy and Conservation Act, as 

amended by the Energy Independence 

and Security Act of 2007. The statute 

requires that CAFE standards be 

prescribed separately for passenger 

automobiles and non-passenger 

automobiles to achieve a combined 

fleet fuel economy of at least 35 mpg 

by model year 2020. For model years 

2021 and beyond, the statute requires 

that the average fuel economy required 

to be attained by each fleet of passenger 

and non-passenger automobiles be the 

maximum feasible for each model year. 

The law requires the standards be set 

at least 18 months prior to the start 

of the model year. On May 21, 2010, 

President Obama issued a 

memorandum directing NHTSA and 

EPA to conduct a joint rulemaking 

(NHTSA regulating fuel economy and 

EPA regulating greenhouse gas 

emissions) and to issue a Notice of 

Intent to Issue a Proposed Rule (NOI) 

by September 30, 2010. 

Statement of Need: 

This rulemaking would respond to 

requirements of the Energy Policy and 

Conservation Act, as amended by the 

Energy Independence and Security Act 


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of 2007. The statute requires that 

corporate average fuel economy 

standards be prescribed separately for 

passenger automobiles and nonpassenger automobiles to achieve a 

combined fleet fuel economy of at least 

35 mpg by model year 2020. For model 

years 2021 and beyond, the statute 

requires that the average fuel economy 

required to be attained by each fleet 

of passenger and non-passenger 

automobiles be the maximum feasible 

for each model year. The law requires 

the standards be set at least 18 months 

prior to the start of the model year, 

and for model year 2017, standards 

must be set by April 1, 2015. On May 

21, 2010, President Obama issued a 

memorandum directing NHTSA and 

EPA conduct joint rulemaking (NHTSA 

regulating fuel economy and EPA 

regulating greenhouse gas emissions) 

and to issue a Notice of Intent to Issue 

a Proposed Rule (NOI) by September 

30, 2010. 

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 not pursuing any 

alternatives. 

Anticipated Cost and Benefits: 

The costs and benefits of the potential 

changes addressed in this action have 

not yet been assessed. 

Risks: 

Depending upon how manufacturers 

use weight reduction to meet the fuel 

economy standards, there is a potential 

impact on motor vehicle safety. The 

2010 NHTSA analysis shows that a 100 

pound reduction in weight, while 

keeping footprint constant, decreases 

the fatality rate for light trucks over 

3,870 lbs. but increases the fatality rate 

for light trucks less than 3,870 lbs. and 

for all passenger cars. An interagency 

team from DOT, EPA, and DOE are 

further examining this issue. 

Timetable: 

Action Date FR Cite 

Notice of Intent (NOI) 10/13/10 75 FR 62739 

NOI Comment Period 

End 

10/31/10 

Supplemental NOI 12/00/10 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

None 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Energy Effects: 

Statement of Energy Effects planned as 

required by Executive Order 13211. 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

James Tamm 

Fuel Economy Division Chief 

Department of Transportation 

National Highway Traffic Safety 

Administration 

1200 New Jersey Avenue SE 

Washington, DC 20590 

Phone: 202 493–0515 

Email: james.tamm@dot.gov 

RIN: 2127–AK79 

DOT—NHTSA 

PROPOSED RULE STAGE 

123. ŒFEDERAL MOTOR VEHICLE 

SAFETY STANDARD NO. 111, 

REARVIEW MIRRORS 

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 30111; 49 USC 30115; 49 USC 

30117; 49 USC 30166; 49 USC 322; 

delegation of authority at 49 CFR 1.50 

CFR Citation: 

49 CFR 571.111 

Legal Deadline: 

Other, Statutory, February 28, 2009, 

Initiate rulemaking. 

Final, Statutory, February 28, 2011. 

Abstract: 

This rulemaking would amend Federal 

Motor Vehicle Standard No. 111; 

Rearview Mirrors, to reflect 

requirements contained in the Cameron 

Gulbransen Kids Transportation Safety 

Act of 2007. The Act requires that 

NHTSA expand the required field of 

view to enable the driver of a motor 

vehicle to detect areas behind the 

motor vehicle to reduce death and 

injury resulting from backing incidents, 

particularly incidents involving small 

children and disabled persons. 

According to the Act, such a standard 

may be met by the provision of 

additional mirrors, sensors, cameras, or 

other technology to expand the driver’s 

field of view. 

Statement of Need: 

Vehicles that are backing up have a 

potential to create a danger to 

pedestrians and pedicyclists. NHTSA 

estimates that backover crashes 

involving light vehicles account for an 

estimated 228 fatalities and 17,000 

injuries annually. In analyzing the data 

further, we found that many of these 

incidents occur off public roadways, in 

areas such as driveways and parking 

lots and that they involve parents (or 

caregivers) accidentally backing over 

children. We have also found that 

children represent approximately 44 

percent of the fatalities, which we 

believe to be unique to this safety 

problem. 

Summary of Legal Basis: 

Section 3011, title 49, of the U.S.C., 

states that the Secretary shall prescribe 

motor vehicle safety standards. 

Alternatives: 

NHTSA is evaluating additional 

mirrors, sensors, cameras, and other 

technology to address this safety 

problem. 

Anticipated Cost and Benefits: 

Costs: $723M to $2.4B 

Benefit: Reduction of 95 to 112 

fatalities and 7.072 to 8.374 injuries. 

Risks: 

The Agency believes there are no 

substantial risks to this rulemaking. 

Timetable: 

Action Date FR Cite 

ANPRM 03/04/09 74 FR 9477 

ANPRM Comment 

Period End 

05/04/09 

NPRM 12/00/10 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79621 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

David Hines 

General Engineer Office of Crash 

Avoidance Standards 

Department of Transportation 

National Highway Traffic Safety 

Administration 

1200 New Jersey Avenue SE. 

Washington, DC 20590 

Phone: 202 366–2720 

Email: dhines@nhtsa.dot.gov 

RIN: 2127–AK43 

DOT—NHTSA 

124. ∑ ŒCOMMERCIAL MEDIUM– AND 

HEAVY–DUTY ON–HIGHWAY 

VEHICLES AND WORK TRUCK FUEL 

EFFICIENCY STANDARDS 

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 32902; delegation of authority 

at 49 CFR 1.50 

CFR Citation: 

49 CFR 523, 534, 535 

Legal Deadline: 

Other, Statutory, September 30, 2010, 

NHTSA Study. 

Final, Statutory, September 28, 2012. 

Abstract: 

This rulemaking would respond to 

requirements of the Energy Policy and 

Conservation Act, as amended by the 

Energy Independence and Security Act 

of 2007. The statute requires that 

rulemaking begin with a report by the 

National Academy of Sciences 

evaluating medium-duty and heavyduty truck fuel economy standards. The 

National Academy provided Congress 

and the NHTSA with this report on 

March 18, 2010. EISA then requires 

that NHTSA complete a study that 

examines the fuel efficiency of 

commercial medium- and heavy-duty 

on-highway vehicles and work trucks 

and determines the appropriate test 

procedures and methodologies for 

measuring the fuel efficiency of such 

vehicles, the appropriate metric for 

measuring the fuel efficiency of such 

vehicles, the range of factors that affect 

the fuel efficiency of these vehicles, 

and other factors that could impact a 

program to improve the fuel efficiency 

of these vehicles. 

The NHTSA study was issued October 

25, 2010. Once that study is completed, 

NHTSA has 24 months to complete a 

final rule establishing a fuel efficiency 

program for these vehicles. The law 

provides that the new standards must 

provide at least 4 full model years of 

regulatory leadtime and 3 full model 

years of regulatory stability (i.e., the 

standards must remain in effect for 3 

years before they may be amended). On 

May 21, 2010, President Obama issued 

a memorandum directing NHTSA and 

EPA conduct a joint rulemaking 

(NHTSA regulating fuel efficiency and 

EPA regulating greenhouse gas 

emissions), and to issue a final rule by 

July 30, 2011. 

Statement of Need: 

Setting fuel consumption standards for 

commercial medium-duty and heavyduty on-highway vehicles and work 

trucks will reduce fuel consumption, 

and will thereby improve U.S. energy 

security by reducing dependence on 

foreign oil, which has been a national 

objective since the first oil price shocks 

in the 1970s. Net petroleum imports 

now account for approximately 60 

percent of U.S. petroleum consumption. 

World crude oil production is highly 

concentrated, exacerbating the risks of 

supply disruptions and price shocks. 

Tight global oil markets led to prices 

over $100 per barrel in 2008, with 

gasoline reaching as high as $4 per 

gallon in many parts of the U.S., 

causing financial hardship for many 

families and businesses. The export of 

U.S. assets for oil imports continues to 

be an important component of the 

historically unprecedented U.S. trade 

deficits. Transportation accounts for 

about 72 percent of U.S. petroleum 

consumption. Medium-duty and heavyduty vehicles account for about 17 

percent of transportation oil use, which 

means that they alone account for about 

12 percent of all U.S. oil consumption. 

Summary of Legal Basis: 

Section 102 of EISA, codified at 49 

U.S.C. 32902(k), requires NHTSA to 

develop a regulatory system for the fuel 

economy of commercial medium-duty 

and heavy-duty on-highway vehicles 

and work trucks in three steps: A study 

by the National Academy of Sciences 

(NAS), a study by NHTSA, and a 

rulemaking to develop the regulations 

themselves. Specifically, 49 U.S.C. 

32902(k)(2) states that not later than 2 

years after completion of the NHTSA 

study, DOT (by delegation, NHTSA), in 

consultation with the Department of 

Energy and EPA, shall develop a 

regulation to implement a ‘‘commercial 

medium-duty and heavy-duty onhighway vehicle and work truck fuel 

efficiency improvement program 

designed to achieve the maximum 

feasible improvement.’’ 

Alternatives: 

NHTSA is evaluating nine alternatives; 

(1) heavy-duty engines, only (2) Class 

8 combination tractors and engines in 

Class 8 tractors, (3) heavy-duty engines 

and Class 7 and 8 tractors, (4) heavyduty engines, Class 7 and 8 tractors, 

and Class 2b/3 pickup trucks and vans, 

(5) NPRM Preferred Alternative: heavyduty engines, tractors, and Class 2b 

through 8 vehicles, (6) heavy-duty 

engines, tractors, Class 2b through 8 

vehicles and trailers, (7) heavy-duty 

engines, tractors, Class2b-8 vehicles, 

and trailers plus advanced hybrid 

power-train technology for Class 2b 

through 8 vocational vehicles, pickups 

and vans, (8)15 percent less stringent 

that the NPRM Preferred Alternative, 

covering heavy-duty engines, tractors, 

and Class 2b through 8 vehicles, (9) 20 

percent more stringent that the NPRM 

Preferred Alternative, covering heavyduty engines, tractors, and Class 2b 

through 8 vehicles. 

Anticipated Cost and Benefits: 

Estimated lifetime discounted costs, 

benefits and net benenfits for all heavyduty vehicles projected to be sold in 

model years 2014-2018: Costs $7.7B, 

Benefits $49.0B, Net Benefits $41B 

(with 3% discount rate). 

Risks: 

The Agency believes there are no 

substantial risks to this rulemaking. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79622 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Energy Effects: 

Statement of Energy Effects planned as 

required by Executive Order 13211. 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

James Tamm 

Fuel Economy Division Chief 

Department of Transportation 

National Highway Traffic Safety 

Administration 

1200 New Jersey Avenue SE 

Washington, DC 20590 

Phone: 202 493–0515 

Email: james.tamm@dot.gov 

Related RIN: Related to 2060–AP61 

RIN: 2127–AK74 

DOT—NHTSA 

FINAL RULE STAGE 

125. ŒEJECTION MITIGATION 

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 30111; 49 USC 30115; 49 USC 

30117; 49 USC 30166; 49 USC 322; 

delegation of authority at 49 CFR 1.50 

CFR Citation: 

49 CFR 571.226 

Legal Deadline: 

Final, Statutory, October 1, 2009. 

Abstract: 

This rulemaking would create a new 

Federal Motor Vehicle Safety Standard 

(FMVSS) for reducing occupant 

ejection. Currently, there are over 

52,000 annual ejections in motor 

vehicle crashes, and over 10,000 ejected 

fatalities per year. This rulemaking 

would propose new requirements for 

reducing occupant ejection through 

passenger vehicle side widows. The 

requirement would be an occupant 

containment requirement on the 

amount of allowable excursion through 

passenger vehicle side windows. The 

SAFETEA-LU legislation requires that: 

‘‘[t]he Secretary shall also initiate a 

rulemaking proceeding to establish 

performance standards to reduce 

complete and partial ejections of 

vehicle occupants from outboard 

seating positions. In formulating the 

standards the Secretary shall consider 

various ejection mitigation systems. 

The Secretary shall issue a final rule 

under this paragraph no later than 

October 1, 2009.’’ The SAFETEA-LU 

legislation also requires that, if the 

Secretary determines that the subject 

final rule deadline cannot be met, the 

Secretary shall notify and provide an 

explanation to the Senate Committee on 

Commerce, Science and Transportation 

and the House of Representatives 

Committee on Energy and Commerce of 

the delay. On September 24, 2009, the 

Secretary provided appropriate 

notification to Congress that the final 

rule will be delayed until January 31, 

2011. 

Statement of Need: 

The agency’s annualized injury data 

from 1997 to 2008 show that there are 

6,412 fatalities and 5,709 Maximum 

Abbreviated Injury Scale (MAIS) 3+ 

non-fatal serious injuries for occupants 

partially and completely ejected 

through side windows in vehicles with 

a gross vehicle weight rating (GVWR) 

less than 4,536 kg (10,000 lbs.). Sixtysix percent of the fatalities and 77 

percent of the serious injuries are from 

ejections that involve a rollover as part 

of the crash event. 

Summary of Legal Basis: 

Section 30111, title 49 of the U.S.C., 

states that the Secretary shall prescribe 

motor vehicle safety standards. Section 

10301 of the Safe, Accountable, 

Flexible, Efficient Transportation 

Equity Act: A Legacy for Users 

(SAFETEA-LU) requires the Secretary 

to issue by October 1, 2009, an ejection 

mitigation final rule reducing complete 

and partial ejections of occupants from 

outboard seating positions. The 

SAFETEA-LU legislation also requires 

that if the Secretary determines that the 

subject final rule deadline cannot be 

met, the Secretary shall notify and 

provide explanation to the Senate 

Committee on Commerce, Science, and 

Transportation and the House of 

Representatives Committee on Energy 

and Commerce of the delay. On 

September 24, 2009, the Secretary 

provided appropriate notification to 

Congress that the final rule will be 

delayed until January 31, 2011. 

Alternatives: 

The Agency is not pursuing any 

alternatives to reduce side window 

ejections of light vehicle occupants 

other than establishing FMVSS No. 226. 

Anticipated Cost and Benefits: 

The agency is reducing the population 

of partial and complete side window 

ejections through a series of rulemaking 

actions. These actions included adding 

a pole impact upgrade to FMVSS No. 

214—Side Impact Protection (72 FR 

51908) and promulgating FMVSS No. 

126—Electronic Stability Control 

Systems (72 FR 17236). In the NPRM 

for this rulemaking, published 

December 2, 2009 (74 FR 63180), we 

estimated that promulgating FMVSS 

No. 226 will reduce the remaining 

population of ejection fatalities and 

serious injuries by the ranges of 390 

to 402 and 296 to 310, respectively. 

The cost per equivalent fatality at a 

seven percent discount rate was 

estimated to be $2.0 million. 

Risks: 

The Agency believes there are no 

substantial risks to this rulemaking and 

that only beneficial outcomes will 

occur as the industry moves to reduce 

side window ejections of light vehicle 

occupants. 

Timetable: 

Action Date FR Cite 

NPRM 12/02/09 74 FR 63180 

NPRM Comment 

Period End 

02/01/10 

Final Action 01/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79623 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Louis Molino 

Safety Standards Engineer 

Department of Transportation 

National Highway Traffic Safety 

Administration 

1200 New Jersey Avenue SE 

Washington, DC 20590 

Phone: 202 366–1833 

Fax: 202 366–4329 

Email: louis.molino@dot.gov 

RIN: 2127–AK23 

DOT—Federal Railroad Administration 

(FRA) 

PROPOSED RULE STAGE 

126. ŒHOURS OF SERVICE: 

PASSENGER TRAIN EMPLOYEES 

(RULEMAKING RESULTING FROM A 

SECTION 610 REVIEW) 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

PL 110–432, Div A, 122 Stat 4848 et 

seq; Rail Safety Improvement Act of 

2008; sec 108(e) (49 USC 21109) 

CFR Citation: 

49 CFR 242 

Legal Deadline: 

NPRM, Statutory, October 16, 2011. 

Abstract: 

This rulemaking would establish hours 

of service requirements for train 

employees engaged in commuter and 

intercity passenger rail transport. 

Statement of Need: 

Required by the Rail Safety 

Improvement Act of 2008, Public Law 

110-432. 

Summary of Legal Basis: 

Required by the Rail Safety 

Improvement Act of 2008, Public Law 

110-432. 

Alternatives: 

The Rail Safety Improvement Act of 

2008 (RSIA of 2008) provides, in 

section 108 (d), that if FRA does not 

have a final regulation in effect by 

October 16, 2011, the hours of service 

requirements for train employees found 

in 49 U.S.C. section 21103, as revised 

by section 108 (b) of the RSIA of 2008, 

will go into effect for train employees 

of commuter and intercity passenger 

railroads. 

Anticipated Cost and Benefits: 

To be determined. 

Risks: 

The regulation is expected to reduce 

the risk of accidents and injuries 

caused or contributed to by fatigue, 

because it will require commuter and 

intercity passenger railroads to analyze 

the risk for fatigue in the schedules 

worked by their train employees, and 

will require that they mitigate the 

fatigue risks in those schedules 

demonstrating a risk for a level of 

fatigue at which safety may be 

compromised. 

Timetable: 

Action Date FR Cite 

NPRM 05/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions 

Government Levels Affected: 

None 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Kathryn Shelton 

Trial Attorney 

Department of Transportation 

Federal Railroad Administration 

1200 New Jersey Avenue SE. 

Washington, DC 20590 

Phone: 202 493–6063 

Email: kathryn.shelton@fra.dot.gov 

RIN: 2130–AC15 

DOT—Federal Transit Administration 

(FTA) 

PROPOSED RULE STAGE 

127. ∑ ŒMAJOR CAPITAL 

INVESTMENT PROJECTS 

Priority: 

Other Significant 

Legal Authority: 

49 USC 5309 

CFR Citation: 

49 CFR 611 

Legal Deadline: 

Final, Statutory, April 7, 2006. 

Abstract: 

This rulemaking, mandated specifically 

by 49 U.S.C. 5309(e)(9), is intended to 

make changes to the regulations that 

govern the New Starts discretionary 

funding program authorized by 49 

U.S.C. 5309. FTA’s initial rulemaking 

on this subject (RIN 2132-AA81), 

initiated to meet the statutory deadline, 

was terminated as the result of 

subsequent congressional action 

prohibiting FTA from issuing a rule. 

Statement of Need: 

Section 3011 of the Safe, Accountable, 

Flexible, Efficient Transportation 

Equity Act—A Legacy for Users 

(SAFETEA-LU) made a number of 

changes to 49 U.S.C. 5309, which 

authorizes the Federal Transit 

Administration’s (FTA) fixed guideway 

capital investment grant program 

known as ‘‘New Starts.’’ SAFETEA-LU 

also added created a new category of 

major capital investments that have a 

total project cost of less than $250 

million and that are seeking less than 

$75 million in section 5309 major 

capital investment funds. This 

rulemaking proposes to implement 

those changes and a number of other 

changes that FTA believes will improve 

the process for evaluating major capital 

investment projects. 

Summary of Legal Basis: 

Section 5309, title 49, of the United 

States Code requires the Secretary to 

promulgate regulations for the 

evaluation and selection of major 

capital investment projects that have a 

total project cost of less than $250 

million, and that are seeking less than 

$75 million in section 5309 major 

capital investment funds. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79624 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Alternatives: 

This rulemaking is mandated by section 

3011 of SAFETEA-LU, so there is not 

an alternative to pursuing rulemaking. 

Within the rulemaking process, FTA 

has already issued and has received 

comments on an Advance Notice of 

Proposed Rulemaking that will inform 

the various options FTA might pursue 

in the Notice of Proposed Rulemaking. 

Anticipated Cost and Benefits: 

The single largest change in the New 

Starts program is the creation in 

SAFETEA-LU of the ‘‘Small Starts’’ 

program. Over the first 10 years of the 

Small Starts program, the cumulative 

impact of transfer from New Starts to 

Small Starts will likely be $1.9 Billion, 

with a Net Present Value of $1.311 

Billion using a discount rate of 7 

percent. This effect is difficult to 

characterize in terms of cost or benefit, 

as it simply represents a ‘‘transfer of 

a transfer’’ from one governmental 

entity to another. 

Risks: 

The proposed rulemaking provides a 

framework for a discretionary grant 

program; it does not propose to regulate 

other than for applicants for Federal 

funds. As such, the rulemaking poses 

no risks for the regulated community, 

other than for the risks inherent in 

pursuing Federal funds that might not 

be awarded if a project fails to satisfy 

the eligibility and evaluation criteria in 

the proposed regulatory structure. 

Timetable: 

Action Date FR Cite 

ANPRM 06/03/10 75 FR 31383 

ANPRM Comment 

Period End 

08/02/10 

NPRM 06/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Christopher VanWyk 

Attorney Advisor 

Department of Transportation 

Federal Transit Administration 

1200 New Jersey Avenue SE. 

Washington, DC 20590 

Phone: 202 366–1733 

Email: christopher.vanwyk@fta.dot.gov 

RIN: 2132–AB02 

DOT—Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA) 

PROPOSED RULE STAGE 

128. ∑ ŒHAZARDOUS MATERIALS: 

LIMITING THE USE OF MOBILE 

TELEPHONES BY HIGHWAY 

Priority: 

Other Significant 

Legal Authority: 

Not Yet Determined 

CFR Citation: 

49 CFR 177 

Legal Deadline: 

None 

Abstract: 

This rulemaking would limit the use 

of mobile telephones by drivers during 

the operation of a motor vehicle 

containing a quantity of hazardous 

materials requiring placarding under 

part 172 of the 49 CFR or any quantity 

of a select agent or toxin listed in 42 

CFR part 73. Additionally, in 

accordance with requirements proposed 

by the Federal Motor Carrier Safety 

Administration (FMCSA), motor 

carriers would be prohibited from 

requiring or allowing drivers of covered 

motor vehicles to engage in the use of 

mobile telephones while driving. This 

rulemaking would improve health and 

safety on the Nation’s highways by 

reducing the prevalence of distracted 

driving-related crashes, fatalities, and 

injuries involving drivers of 

commercial motor vehicles. 

Statement of Need: 

This rulemaking expands on mobile 

phone limitations under development 

by FMCSA that would limit the use of 

mobile phones by drivers transporting 

a quantity of hazardous materials 

requiring placarding under part 172 of 

the 49 CFR or any quantity of a 

material listed as a select agent or toxin 

in 42 CFR part 73 in intrastate 

commerce. FMCSA’s authority over 

motor carriers of these materials is 

limited to transportation in interstate 

commerce. The safety benefits 

associated with limiting the distractions 

caused by mobile phones are equally 

applicable to drivers transporting 

covered hazardous materials via 

intrastate as they are to interstate 

commerce. The use of a mobile phone 

while driving constitutes a safety risk 

to the motor vehicle driver, other 

motorists, and bystanders. 

Summary of Legal Basis: 

Federal hazardous materials 

transportation law (Federal hazmat law; 

49 U.S.C. 5101 et seq.) 

Alternatives: 

PHMSA will consider two alternatives: 

1. Amend the HMR to expand the 

scope of the FMCSA NPRM to include 

those intrastate motor carriers and 

drivers that transport a quantity of 

hazardous materials requiring 

placarding under part 172 of the 49 

CFR or any quantity of a material listed 

as a select agent or toxin in 42 CFR 

part 73; or 

2. Take no action. 

Anticipated Cost and Benefits: 

Not yet calculated. However, the 

population of motor carriers affected 

will be less than 1,500. PHMSA expects 

costs to be minimal when compared to 

the risks of distracted driving. 

Risks: 

Risk to the public and regulated 

community from distracted drivingrelated crashes, fatalities, and injuries 

involving drivers of commercial motor 

vehicles transporting covered 

hazardous materials in intrastate 

commerce. 

Timetable: 

Action Date FR Cite 

NPRM 09/17/10 75 FR 56972 

NPRM Comment 

Period Extended 

11/16/10 75 FR 66912 

NPRM Comment 

Period End 

11/16/10 

NPRM Comment 

Period Extended 

End 

12/03/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79625 

Government Levels Affected: 

None 

Additional Information: 

HM-256A 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Ben Supko 

Transportation Regulations Specialist 

Department of Transportation 

Pipeline and Hazardous Materials Safety 

Administration 

1200 New Jersey Avenue SE 

Washington, DC 20590 

Phone: 202 366–8553 

Email: ben.supko@dot.gov 

RIN: 2137–AE65 

DOT—PHMSA 

FINAL RULE STAGE 

129. ∑ ŒHAZARDOUS MATERIALS: 

LIMITING THE USE OF ELECTRONIC 

DEVICES BY HIGHWAY 

Priority: 

Other Significant 

Legal Authority: 

Not Yet Determined 

CFR Citation: 

49 CFR 177 

Legal Deadline: 

None 

Abstract: 

This rulemaking would restrict the use 

of electronic devices by drivers during 

the operation of a motor vehicle 

containing a quantity of hazardous 

materials requiring placarding under 

part 172 of the 49 CFR or any quantity 

of a material listed as a select agent 

or toxin in 42 CFR part 73. 

Additionally, in accordance with 

requirements proposed by the Federal 

Motor Carrier Safety Administration 

(FMCSA) motor carriers are prohibited 

from requiring or allowing drivers of 

covered motor vehicles to engage in 

texting while driving. This rulemaking 

would improve health and safety on the 

Nation’s highways by reducing the 

prevalence of distracted driving-related 

crashes, fatalities, and injuries 

involving drivers of commercial motor 

vehicles. 

Statement of Need: 

This rulemaking expands on the 

limitations on wireless communications 

proposed by FMCSA’s April 1, 2010, 

NPRM to the transportation of a 

quantity of hazardous materials 

requiring placarding under part 172 of 

the 49 CFR or any quantity of a 

material listed as a select agent or toxin 

in 42 CFR part 73 in intrastate 

commerce. FMCSA’s authority over 

motor carriers of these materials is 

limited to transportation in interstate 

commerce. The safety benefits 

associated with limiting the distractions 

caused by electronic devices are 

equally applicable to drivers 

transporting covered hazardous 

materials via intrastate as they are to 

interstate commerce. The use of an 

electronic device while driving 

constitutes a safety risk to the motor 

vehicle driver, other motorists, and 

bystanders. 

Summary of Legal Basis: 

Federal hazardous materials 

transportation law (Federal hazmat law; 

49 U.S.C. 5101 et seq.) 

Alternatives: 

PHMSA considered two alternatives: 

1. Amend the HMR to expand the 

scope of the FMCSA NPRM to include 

those intrastate motor carriers and 

drivers that transport a quantity of 

hazardous materials requiring 

placarding under part 172 of the 49 

CFR or any quantity of a material listed 

as a select agent or toxin in 42 CFR 

part 73; or 

2. Take no action. 

Anticipated Cost and Benefits: 

PHMSA estimates that this proposed 

rule will cost $5,227 annually. 

Additionally, PHMSA has not 

identified a significant increase in crash 

risk associated with drivers? strategies 

for complying with this proposed rule. 

As indicated in the regulatory 

evaluation, a crash resulting in property 

damage only (PDO) averages 

approximately $17,000 in damages. 

Consequently, the texting restriction 

would have to eliminate just one PDO 

crash every 3.25 years for the benefits 

of this proposed rule to exceed the 

costs. 

Risks: 

Risk to the public and regulated 

community from distracted drivingrelated crashes, fatalities, and injuries 

involving drivers of commercial motor 

vehicles transporting covered 

hazardous materials in intrastate 

commerce. 

Timetable: 

Action Date FR Cite 

NPRM 09/27/10 75 FR 59197 

NPRM Comment 

Period End 

10/27/10 

Final Rule 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Additional Information: 

HM-256 

URL For More Information: 

www.regulations.gov 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Ben Supko 

Transportation Regulations Specialist 

Department of Transportation 

Pipeline and Hazardous Materials Safety 

Administration 

1200 New Jersey Avenue SE 

Washington, DC 20590 

Phone: 202 366–8553 

Email: ben.supko@dot.gov 

RIN: 2137–AE63 

BILLING CODE 4910–9X–S 


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79626 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

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 the U.S. and international 

financial systems from those who would 

use these systems for illegal purposes or 

to compromise U.S. national security 

interests, while keeping them free and 

open to legitimate users. 

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. It is the policy of the 

Department to comply with 

requirements 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. 

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 July 21, 2010, the President signed 

the Dodd-Frank Wall Street Reform and 

Consumer Protection Act (Pub. L. 111- 

203, 124 Stat. 1376). Over the next 

several months, the Department will 

continue implementing the Act, 

including promulgating regulations 

required under the Act. 

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. 

Emergency Economic Stabilization Act 

On October 3, 2008, the President 

signed the Emergency Economic 

Stabilization Act of 2008 (EESA) (Pub. 

L. 110-334). Section 101(a) of EESA 

authorizes the Secretary of the Treasury 

to establish a Troubled Asset Relief 

Program (TARP) to ‘‘purchase, and to 

make and fund commitments to 

purchase, troubled assets from any 

financial institution on such terms and 

conditions as are determined by the 

Secretary and in accordance with this 

Act and policies and procedures 

developed and published by the 

Secretary.’’ 

EESA provides authority to issue 

regulations and guidance to implement 

the program. Regulations and guidance 

required by EESA include conflicts of 

interest, executive compensation, and 

tax guidance. The Secretary is also 

charged with establishing a program 

that will guarantee principal of, and 

interest on, troubled assets originated or 

issued prior to March 14, 2008. 

The Department has issued guidance 

and regulations and will continue to 

provide program information through 

the next year. Regulatory actions taken 

to date include the following: 

Executive compensation. In October 

2008, the Department issued an interim 

final rule that set forth executive 

compensation guidelines for the TARP 

Capital Purchase Program (73 FR 

62205). Related tax guidance on 

executive compensation was announced 

in IRS Notice 2008-94. In addition, 

among other EESA tax guidance, the IRS 

issued interim guidance regarding loss 

corporation and ownership changes in 

Notice 2008-100, providing that any 

shares of stock owned by the 

Department of the Treasury under the 

Capital Purchase Program will not be 

considered to cause Treasury’s 

ownership in such corporation to 

increase. On June 15, 2009, the 

Department issued a revised interim 

final rule that sets forth executive 

compensation guidelines for all TARP 

program participants (74 FR 28394), 

implementing amendments to the 

executive compensation provisions of 

EESA made by the American Recovery 

and Reinvestment Act of 2009 (Pub. 

L.111-5). Public comments on the 

revised interim final rule regarding 

executive compensation were due by 

August 14, 2009, and will be considered 

as part of the process of issuing a final 

rule on this subject. 

Insurance program for trouble assets. 

On October 14, 2008, the Department 

released a request for public input on an 

insurance program for troubled assets. 

Conflicts of interest. On January 21, 

2009, the Department issued an interim 

final rule providing guidance on 

conflicts of interest pursuant to section 

108 of EESA (74 FR 3431). Comments 

on the interim final rule, which were 

due by March 23, 2009, will be 

considered as part of the process of 

issuing a final rule. 

The Department will continue 

implementing the EESA authorities to 

restore capital flows to the consumers 

and businesses that form the core of the 

Nation’s economy. 

Terrorism Risk Insurance Program 

Office 

The Terrorism Risk Insurance Act of 

2002 (TRIA) was signed into law on 

November 26, 2002. The law, which was 

enacted as a consequence of the events 

of September 11, 2001, established a 

temporary Federal reinsurance program 

under which the Federal Government 

shares the risk of losses associated with 

certain types of terrorist acts with 

commercial property and casualty 

insurers. The Act, originally scheduled 

to expire on December 31, 2005, was 

extended to December 31, 2007, by the 

Terrorism Risk Insurance Extension Act 

of 2005 (TRIEA). The Act has since been 

extended to December 31, 2014, by the 

Terrorism Risk Insurance Program 

Reauthorization Act of 2007 (TRIPRA). 

The Office of the Assistant Secretary 

for Financial Institutions is responsible 

for developing and promulgating 

regulations implementing TRIA, as 

extended and amended by TRIEA and 

TRIPRA. 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 TRIA. 

The purposes of this legislation 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. 


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Over the past year, the Office of the 

Assistant Secretary has issued proposed 

rules implementing changes authorized 

by TRIA as revised by TRIPRA. The 

following regulations should be 

published by December 31, 2010: 

Final Netting. This rule would establish 

procedures by which, after the Secretary 

has determined that claims for the 

Federal share of insured losses arising 

from a particular Program Year shall be 

considered final, a final netting of 

payments to or from insurers will be 

accomplished. 

Affiliates. This rule would make 

changes to the definition of ‘‘affiliate’’ to 

conform to the language in the statute 

Civil Penalty. This rule establishes 

procedures by which the Secretary may 

assess civil penalties against any insurer 

that the Secretary determines, on the 

record after an opportunity for a hearing 

has violated provisions of the Act. 

Renewals. Certain claims rules will be 

published for renewal without change. 

During 2011, Treasury will continue 

the ongoing work of implementing TRIA 

and carrying out revised operations as a 

result of the TRIPRA related regulation 

changes. 

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 was known as the Bureau of 

Customs and Border Protection (CBP). 

Effective March 31, 2007, DHS changed 

the name of the Bureau of Customs and 

Border Protection to U.S. Customs and 

Border Protection (CBP) pursuant to 

section 872(a)(2) of the Act (6 U.S.C. 

452(a)(2)) in a Federal Register notice 

(72 FR 20131) published on April 23, 

2007. 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 subject to 

certain exceptions. 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 the past fiscal year, among the 

Treasury-retained CBP customs-revenue 

function regulations issued was a final 

rule that adopted the interim 

amendments updating the regulatory 

provisions relating to the requirement 

under the United States-Bahrain FTA 

(BFTA) that a good must be ‘‘imported 

directly’’ from Bahrain to the United 

States or from the United States to 

Bahrain to qualify for preferential tariff 

treatment. The change removed the 

condition that a good passing through 

the territory of an intermediate country 

must remain under the control of the 

customs authority of the intermediate 

country. CBP also finalized the interim 

regulations, which implemented the 

preferential tariff treatment provisions 

of the Dominican Republic-Central 

America-United States Free Trade 

Agreement (also known as ‘‘CAFTADR’’) Implementation Act. 

In addition, during the past fiscal 

year, CBP finalized the interim 

amendments of the regulations to 

implement certain provisions of the 

Tom Lantos Block Burmese JADE 

(Junta’s Anti-Democratic Efforts) Act of 

2008 (Pub. L. 110-286) (the ‘‘JADE Act’’) 

and Presidential Proclamation 8294 of 

September 26, 2008, which includes 

new Additional U.S. Note 4 to chapter 

71 of the Harmonized Tariff Schedule of 

the United States (‘‘HTSUS’’). The final 

amendments prohibit the importation of 

Burmese-covered articles of jadeite, 

rubies, and articles of jewelry 

containing jadeite or rubies, and sets 

forth restrictions for the importation of 

non-Burmese covered articles of jadeite, 

rubies, and articles of jewelry 

containing jadeite or rubies. 

As a result of the Softwood Lumber 

Act of 2008, CBP finalized the interim 

regulations to parts 12 and 163 of the 

regulations that prescribed special entry 

requirements as well as an importer 

declaration program applicable to 

certain softwood lumber (SWL) and 

SWL products exported from any 

country into the United States. The 

regulations also implemented the Act’s 

recordkeeping requirements applicable 

to certain imports of SWL home 

packages and kits that are subject to 

declaration requirements but that are 

not subject to the SWL importer 

declaration program. 

This past fiscal year, consistent with 

the practice of continuing to move 

forward with Customs Modernization 

provisions of the North American Free 

Trade Implementation Act to improve 

its regulatory procedures, Treasury and 

CBP finalized its proposal to establish 

the remote location filing program, 

which had been a test program under 

the Customs Modernization Act for 

many years. This rule permits remote 

location filing of electronic entries of 

merchandise from a location other than 

where the merchandise arrives. In 

addition, Treasury and CBP also 

finalized a proposal which was 

published in August 2008 regarding the 

electronic payment and refund of 

quarterly harbor maintenance fees. The 

rule provides the trade with expanded 

electronic payment/refund options for 

quarterly harbor maintenance fees and it 

modernizes and enhances CBP’s port 

use fee collection efforts. 

During fiscal year 2011, CBP and 

Treasury plan to give priority to the 

following regulatory matters involving 

the customs revenue functions not 

delegated to DHS: 

Trade Act of 2002’s preferential trade 

benefit provisions. Treasury and CBP 

plan to finalize several interim 

regulations that implement the trade 

benefit provisions of the Trade Act of 

2002 including the Caribbean Basin 

Economic Recovery Act and the African 

Growth and Opportunity Act. 

Free Trade Agreements. Treasury and 

CBP also plan to finalize interim 

regulations this fiscal year to implement 

the preferential tariff treatment 

provisions of the United StatesSingapore Free Trade Agreement 

Implementation Act. Treasury and CBP 

also expect to issue interim regulations 

implementing the United StatesAustralia Free Trade Agreement 

Implementation Act, the United StatesOman Free Trade Agreement 

Implementation Act, and the United 

States-Peru Free Trade Agreement 

Implementation Act. 

Country of Origin of Textile and 

Apparel Products. Treasury and CBP 

also plan to publish a final rule 

adopting an interim rule that was 

published on the Country of Origin of 

Textile and Apparel Products, which 

implemented the changes brought 

about, in part, by the expiration of the 

Agreement on Textile and Clothing and 


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the resulting elimination of quotas on 

the entry of textile and apparel products 

from World Trade Organizations (WTO) 

members. 

North American Free Trade Agreement 

Country of Origin Rules. Based upon the 

public comments received on its July 

25, 2008, proposal regarding 

establishing uniform rules governing 

CBP’s determinations of the country of 

origin of imported merchandise, 

Treasury and CBP has decided not to 

proceed with this proposal. Instead, 

Treasury and CBP plan to withdraw the 

proposal to establish uniform rules of 

origin to all trade and to adopt as final 

regulations certain proposed 

amendments to the country of origin 

rules codified in part 102 of the CBP 

regulations applicable to pipe fittings 

and flanges, greeting cards, glass optical 

fiber, rice preparations, and certain 

textile products. 

Customs and Border Protection’s Bond 

Program. Treasury and CBP plan to 

finalize its proposal to amend the 

regulations to reflect the centralization 

of the continuous bond program at 

CBP’s Revenue Division. The changes 

proposed support CBP’s bond program 

by ensuring an efficient and uniform 

approach to the approval, maintenance, 

and periodic review of continuous 

bonds as well as accommodating the use 

of information technology and modern 

business practices. 

Courtesy Notices of Liquidation. 

Treasury and CBP plan to finalize its 

proposal to amend the regulations 

pertaining to the method by which CBP 

issues courtesy notices of liquidation in 

an effort to streamline the notification 

process and reduce printing and mailing 

costs. 

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 

CDFI Fund is to promote economic 

revitalization and community 

development through the following 

programs: The Community 

Development Financial Institutions 

(CDFI) Program, the Bank Enterprise 

Award (BEA) Program, the Native 

American CDFI Assistance (NACA) 

Program, and the New Markets Tax 

Credit (NMTC) Program. In addition the 

CDFI Fund administers the Financial 

Education and Counseling Pilot Program 

(FEC) and the Capital Magnet Fund 

(CMF). 

In fiscal year (FY) 2011, subject to 

funding availability, the Fund will 

provide awards through the following 

programs: 

Native American CDFI Assistance 

(NACA) Program. Through the NACA 

Program, the CDFI Fund will provide 

technical assistance grants and financial 

assistance awards to promote the 

development of CDFIs that serve Native 

American, Alaska Native, and Native 

Hawaiian communities. 

Bank Enterprise Award (BEA) Program. 

Through the BEA Program, the CDFI 

Fund will provide financial incentives 

to encourage insured depository 

institutions to engage in eligible 

development activities and to make 

equity investments in CDFIs. 

New Markets Tax Credit (NMTC) 

Program. Through the NMTC Program, 

the CDFI Fund will provide allocations 

of tax credits to qualified community 

development entities (CDEs). The CDEs 

in turn provide tax credits to private 

sector investors in exchange for their 

investment dollars; investment proceeds 

received by the CDEs are to be used to 

make loans and equity investments in 

low-income communities. The CDFI 

Fund administers the NMTC Program in 

coordination with the Office of Tax 

Policy and the Internal Revenue Service. 

Financial Education and Counseling 

(FEC) Pilot Program. Through the FEC 

Pilot Program, the CDFI Fund will 

provide grants to eligible organizations 

to provide a range of financial education 

and counseling services to prospective 

homebuyers. The CDFI Fund will 

administer the FEC Program in 

coordination with the Office of 

Financial Education. 

Capital Magnet Fund (CMF). Through 

the Capital Magnet Fund, the CDFI 

Fund will provide competitively 

awarded grants to CDFIs and qualified 

nonprofit housing organizations to 

finance affordable housing and related 

community development projects. In FY 

2010, the Fund expects to draft and 

publish regulations to govern the 

application process, award selection, 

and compliance components of the 

CMF. 

Bond Guarantee (Small Business Jobs 

and Credit Act of 2010, Pub. L. No. 111- 

240, Section 1134). Pursuant to section 

1134 of Public Law No. 111-240, the 

Treasury Department is required to 

promulgate regulations implementing 

the bond guarantee provisions by 

September 2011. The program must 

then be implemented no later than 

September 2012 and sunsets on 

September 30, 2014. 

Financial Crimes Enforcement Network 

As chief administrator of the Bank 

Secrecy Act (BSA), the Financial Crimes 

Enforcement Network (FinCEN) is 

responsible for developing and 

implementing regulations that are the 

core of the Department’s anti-money 

laundering and counter-terrorism 

financing programmatic efforts. 

FinCEN’s responsibilities and objectives 

are linked to, and flow from, that role. 

In fulfilling this role, FinCEN seeks to 

enhance U.S. national security by 

making the financial system 

increasingly resistant to abuse by money 

launderers, terrorists and their financial 

supporters, and other perpetrators of 

crime. 

The Secretary of the Treasury, 

through FinCEN, is authorized by the 

BSA to issue regulations requiring 

financial institutions to file reports and 

keep records that are determined to 

have a high degree of usefulness in 

criminal, tax, or regulatory matters or in 

the conduct of intelligence or counterintelligence activities to protect against 

international terrorism. Those 

regulations also require designated 

financial institutions to establish antimoney laundering programs and 

compliance procedures. To implement 

and realize its mission, FinCEN has 

established regulatory objectives and 

priorities to safeguard the financial 

system from the abuses of financial 

crime, including terrorist financing, 

money laundering, and other illicit 

activity. These objectives and priorities 

include: (1) Issuing, interpreting, and 

enforcing compliance with regulations 

implementing the BSA; (2) supporting, 

working with, and, as appropriate, 

overseeing compliance examination 

functions delegated to other Federal 

regulators; (3) managing the collection, 

processing, storage, and dissemination 

of data related to the BSA; (4) 

maintaining a Governmentwide access 

service to that same data, and for 

network users with overlapping 

interests; (5) conducting analysis in 

support of policymakers, law 

enforcement, regulatory and intelligence 

agencies, and the financial sector; and 

(6) coordinating with and collaborating 

on anti-terrorism and anti-money 

laundering initiatives with domestic law 

enforcement and intelligence agencies, 

as well as foreign financial intelligence 

units. 

During fiscal year 2010, FinCEN 

issued the following regulatory actions: 

Administrative Rulings. On November 

17, 2009, FinCEN issued a final 

technical rule change to update the BSA 

provisions to reflect that Administrative 


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Rulings are published on the FinCEN 

Web site, rather than in the Federal 

Register, allowing information to be 

distributed more broadly and more 

expediently. 

Prepaid Access—Regulatory Framework 

for Activity Previously Referred to as 

Stored Value. On June 28, 2010, FinCEN 

issued a Notice of Proposed Rulemaking 

(NPRM) that would establish a more 

comprehensive regulatory framework 

for non-bank prepaid access. The 

proposed rule, which focuses on 

prepaid programs that pose the greatest 

potential risks of money laundering and 

terrorist financing, was developed in 

close cooperation with law enforcement 

and regulatory authorities. 

The proposed changes impose 

obligations on the party within any 

given prepaid access transaction chain 

with predominant oversight and control, 

as well as others who might be in a 

position to provide meaningful 

information to regulators and law 

enforcement, such as prepaid access 

sellers. Although mandated by the 

Credit Card Accountability, 

Responsibility, and Disclosure Act 

(CARD Act) of 2009 (section 503) to 

issue a final rule ‘‘regarding issuance, 

sale, redemption, or international 

transport of stored value,’’ rulemaking 

activities were already underway. Just 

prior to the enactment of the CARD Act, 

FinCEN issued an NPRM clarifying the 

applicability of BSA regulations with 

respect to MSB activities. As part of this 

NPRM, FinCEN solicited comments on 

various prepaid/stored value issues to 

assist with future rulemakings. 

Confidentiality of Suspicious Activity 

Reports. On March 3, 2009, FinCEN 

issued a Notice of Proposed Rulemaking 

clarifying the non-disclosure provisions 

with respect to the existing regulations 

pertaining to the confidentiality of 

suspicious activity reports (SARs). In 

conjunction with this notice, FinCEN 

issued for comment two guidance 

documents, SAR Sharing with Affiliates 

for depository institutions and SAR 

Sharing with Affiliates for securities and 

futures industry entities, to solicit 

comment permitting certain financial 

institutions to share SARs with their 

U.S. affiliates that are also subject to 

SAR reporting requirements. FinCEN 

expects to publish the final rule before 

the end of 2010. 

Mutual Funds. On April 14, 2010, 

FinCEN issued a Final Rule to include 

mutual funds within the general 

definition of ‘‘financial institutions’’ in 

BSA regulations, subjecting mutual 

funds to rules on the filing of Currency 

Transaction Reports (CTRs) for cash 

transactions over $10,000 in lieu of 

current obligations to file Form 8300s, 

and on the creation, retention, and 

transmittal of records or information for 

transmittals of funds. In addition, the 

final rule harmonized the definition of 

mutual fund in the AML program rule 

with the definitions found in the other 

BSA rules to which mutual funds are 

subject. 

Non-Bank Residential Mortgage Lenders 

and Originators. On July 21, 2009, 

FinCEN issued an Advance Notice of 

Proposed Rulemaking to solicit public 

comment on a wide range of questions 

pertaining to the possible application of 

anti-money laundering (AML) program 

and suspicious activity report (SAR) 

regulations to a specific sub-set of loan 

and finance companies, i.e., non-bank 

residential mortgage lenders and 

originators FinCEN is working on a 

Notice of Proposed Rulemaking that 

would require nonbank residential 

mortgage lenders and originators to 

implement AML program and SAR 

filing requirements, which is expected 

to be published prior to the end of 2010. 

Expansion of Special Information 

Sharing Procedures (pursuant to section 

314(a) of the BSA). On February 10, 

2010, FinCEN issued a Final Rule to 

amend the BSA regulations to allow 

certain foreign law enforcement 

agencies, State and local law 

enforcement agencies, as well as 

FinCEN and other appropriate 

components of the Department of the 

Treasury to submit requests for 

information to financial institutions. 

FBAR Requirements. On February 26, 

2010, working with Treasury Tax Policy 

and the IRS, FinCEN issued an NPRM 

with regard to revising the regulations 

governing the filing of Reports of 

Foreign Bank and Financial Accounts 

(FBARs). Among other things, FinCEN 

and the IRS will seek comments 

regarding when a person with signature 

authority over, but no financial interest 

in, a foreign financial account should be 

relieved of filing an FBAR for the 

account, and when an interest in a 

foreign entity (e.g., a corporation, 

partnership, trust or estate) should be 

subject to FBAR reporting. The final 

rule is expected to be published in FY 

2011. 

Cross Border Electronic Transmittal of 

Funds. FinCEN drafted a Notice of 

Proposed Rulemaking (NPRM) in 

conjunction with the feasibility study 

prepared pursuant to the Intelligence 

Reform and Terrorism Prevention Act of 

2004 concerning the issue of obtaining 

information about certain cross-border 

funds transfers and transmittals of 

funds. The NPRM proposes 

requirements for certain banks and 

money transmitters to submit reports of 

transmittal orders associated with 

certain cross border electronic 

transmittals of funds. In addition, the 

proposal would require an annual filing 

with FinCEN by all banks of a list of 

taxpayer identification numbers of 

accountholders who transmitted or 

received a cross border electronic 

transmittal of funds that is subject to 

reporting. FinCEN published the NPRM 

on September 30, 2010. 

Renewal of Existing Rules. FinCEN 

renewed without change a number of 

information collections associated with 

existing requirements: The Currency 

Transaction Report requiring financial 

institutions to report cash transactions 

over $10,000 (FinCEN Form 104), 

regulations requiring businesses to 

report cash payments over $10,000 

received in a trade or business (FinCEN 

Form 8300), two USA PATRIOT Act 

regulations imposing special measures 

against the Commercial Bank of Syria 

including its subsidiary, Syrian 

Lebanese Commercial Bank, a USA 

Patriot Act regulation imposing special 

measures against Banco Delta Asia, and 

regulations requiring certain financial 

institutions to establish special due 

diligence programs for correspondent 

accounts for foreign financial 

institutions. 

Special Due Diligence Programs for 

Certain Foreign Accounts. As a result of 

a congressional mandate to prescribe 

regulations under the Comprehensive 

Iran Sanctions, Accountability, and 

Divestment Act of 2010, FinCEN is 

revising the BSA regulations to 

incorporate an additional relevant factor 

for a covered financial institution to 

consider when assessing the money 

laundering risks presented by 

correspondent accounts for foreign 

financial institutions. FinCEN expects to 

issue a final rule change to 103.176 

before the end of 2010. 

Administrative Rulings and Written 

Guidance. FinCEN issued 37 

Administrative Rulings, written 

responses to interpretive questions, and 

written guidance pieces interpreting the 

BSA and providing clarity to regulated 

industries. 

FinCEN’s regulatory priorities for 

fiscal year 2011 include finalizing any 

initiatives mentioned above that are not 

finalized by fiscal year end, as well as 

the following projects: 

Reorganization of BSA Rules. On 

October 23, 2008, FinCEN issued a 

Notice of Proposed Rulemaking to reVerDate Mar<15>2010 19:21 Dec 17, 2010 Jkt 223001 PO 00000 Frm 00171 Fmt 1260 Sfmt 1260 E:\FR\FM\20DEP5.SGM 20DEP5

jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79630 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

designate and reorganize the BSA 

regulations in a new chapter within the 

Code of Federal Regulations. The redesignation and reorganization of the 

regulations in a new chapter is not 

intended to alter regulatory 

requirements. The regulations will be 

organized in a more consistent and 

intuitive structure that more easily 

allows financial institutions to identify 

their specific regulatory requirements 

under the BSA. The new chapter will 

replace 31 CFR part 103. 

Money Services Businesses-Definitions 

and Other Regulations. On May 12, 

2009, FinCEN issued a Notice of 

Proposed Rulemaking revising the 

definitions for Money Services 

Businesses (MSBs) to delineate more 

clearly the scope of entities regulated as 

MSBs, incorporating previously issued 

Administrative Rules and guidance with 

regard to MSBs, and ensuring that 

certain foreign-located persons engaging 

in MSB activities within the United 

States are subject to BSA rules. FinCEN 

expects to issue a Final Rule in fiscal 

year 2011. 

Anti-Money Laundering Programs. 

Pursuant to section 352 of the USA 

PATRIOT Act, certain financial 

institutions are required to establish 

AML programs. Continued from prior 

fiscal years, FinCEN is researching and 

developing rulemaking to require Statechartered credit unions and other 

depository institutions without a 

Federal functional regulator to 

implement AML programs. FinCEN also 

is researching and developing AML 

program (and SAR reporting) 

requirements for investment advisers. 

Finally, FinCEN also will continue to 

consider regulatory options regarding 

additional loan and finance companies, 

and certain corporate and trust service 

providers. 

Other Requirements. FinCEN also 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 to enhance 

regulatory efficiency. 

Internal Revenue Service 

The Internal Revenue Service (IRS), 

working with the Office of the Assistant 

Secretary (Tax Policy), promulgates 

regulations that interpret and 

implement the Internal Revenue Code 

and related tax statutes. The purpose of 

these regulations is to carry out the tax 

policy determined by Congress in a fair, 

impartial, and reasonable manner, 

taking into account the intent of 

Congress, the realities of relevant 

transactions, the need for the 

Government to administer the rules and 

monitor compliance, and the overall 

integrity of the Federal tax system. The 

goal is to make the regulations practical 

and as clear and simple as possible. 

Most IRS regulations interpret tax 

statutes to resolve ambiguities or fill 

gaps in the tax statutes. This includes 

interpreting particular words, applying 

rules to broad classes of circumstances, 

and resolving apparent and potential 

conflicts between various statutory 

provisions. 

During fiscal year 2011, the IRS will 

accord priority to the following 

regulatory projects: 

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 amount paid to acquire, 

produce, or improve 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 or appreciably prolong its 

life, the IRS and Treasury believe that 

additional clarification is needed to 

reduce uncertainty and controversy in 

this area. In August 2006, the IRS and 

Treasury issued proposed regulations in 

this area and received numerous 

comments. In March 2008, the IRS and 

Treasury withdrew the 2006 proposed 

regulations and issued new proposed 

regulations, which have generated 

relatively few comments. The IRS and 

Treasury intend to finalize those 

regulations. 

Arbitrage Investment Restrictions on 

Tax-Exempt Bonds. The arbitrage 

investment restrictions on tax-exempt 

bonds under section 148 generally limit 

issuers from investing bond proceeds in 

higher-yielding investments. Treasury 

and the IRS plan to issue proposed 

regulations to address selected current 

issues involving the arbitrage 

restrictions, including guidance on the 

issue price definition used in the 

computation of bond yield, working 

capital financings, grants, investment 

valuation, modifications and 

terminations of qualified hedging 

transactions, and selected other issues. 

Tax Credit Bonds. Tax credit bonds are 

bonds in which the holder receives a 

Federal tax credit in lieu of some or all 

of the interest on the bond. The 

American Recovery and Reinvestment 

Act of 2009 created a number of new 

types of tax credit bonds and modified 

the law as it concerned several existing 

types of tax credit bonds. The Hiring 

Incentives to Restore Employment Act 

added subsection (f) to section 6431 

which authorizes issuers to receive 

Federal direct payments of allowances 

of refundable tax credits in lieu of the 

Federal tax credits that otherwise would 

be allowed to holders of certain tax 

credit bonds. The IRS and Treasury 

intend to provide guidance on selected 

legal issues concerning tax credit bonds 

and remedial actions involving 

refundable tax credit bonds. 

Build America Bonds. Treasury and the 

IRS plan to issue proposed regulations 

to provide guidance on interpretative 

issues that have arisen in implementing 

the broad new Build America Bond 

program in section 54AA, which was 

created by the American Recovery and 

Reinvestment Act of 2009. 

Guidance on the Tax Treatment of 

Distressed Debt. A number of tax issues 

relating to the amount, character, and 

timing of income, expense, gain, or loss 

on distressed debt remain unresolved. 

In addition, the tax treatment of 

distressed debt, including distressed 

debt that has been modified, may affect 

the qualification of certain entities for 

tax purposes or result in additional 

taxes on the investors in such entities, 

such as regulated investment 

companies, real estate investment trusts, 

and real estate mortgage investment 

conduits (REMICs). During fiscal year 

2010, Treasury and the IRS have 

addressed some of these issues through 

published guidance, including (1) two 

revenue procedures providing relief for 

certain modifications of distressed 

commercial mortgage loans held by a 

REMIC, (2) a notice providing that 

interest deductions for certain 

refinanced corporate indebtedness 

issued in 2010 would not be deferred or 

disallowed under section 163(e)(5), and 

(3) proposed regulations clarifying that 

the deterioration in the financial 

condition of the issuer of a modified 

debt instrument is not taken into 

account to determine whether the 

instrument is debt or equity. Treasury 


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and the IRS plan to address more of 

these issues in published guidance. 

Elective Deferral of Certain Business 

Discharge of Indebtedness Income. In 

the recent economic downturn, many 

business taxpayers realized income as a 

result of modifying the terms of their 

outstanding indebtedness or refinancing 

on terms subjecting them to less risk of 

default. The American Recovery and 

Reinvestment Act of 2009 includes a 

special relief provision allowing for the 

elective deferral of certain discharge of 

indebtedness income realized in 2009 

and 2010. The provision, section 108(i) 

of the Code, is complicated and many of 

the details will have to be supplied 

through regulatory guidance. On August 

9, 2009, Treasury and the IRS issued 

Revenue Procedure 2009-37 that 

prescribes the procedure for making the 

election. Treasury and the IRS recently 

promulgated temporary and proposed 

regulations (TD 9497 and TD 9498), 

which were published in the Federal 

Register on August 13, 2010. These 

regulations provide additional guidance 

on such issues as the types of 

indebtedness eligible for the relief, 

acceleration of deferred amounts, the 

operation of the provision in the context 

of flow-through entities, the treatment of 

the discharge for the purpose of 

computing earnings and profits, and the 

operation of a provision of the statute 

deferring original issue discount 

deductions with respect to related 

refinancings. Treasury and the IRS 

intend to issue final regulations. 

Regulation of Tax Return Preparers. In 

June 2009, the IRS launched a 

comprehensive review of the tax return 

preparer program with the intent to 

propose a set of recommendations to 

ensure uniform and high ethical 

standards of conduct for all tax return 

preparers and to increase taxpayer 

compliance. The IRS published findings 

and recommendations in Publication 

4832, Return Preparer Review. In the 

report, the IRS recommended increased 

oversight of the tax return preparer 

industry, including but not limited to, 

mandatory preparer tax identification 

number (PTIN) registration and usage, 

competency testing, continuing 

education requirements, and ethical 

standards for all tax return preparers. As 

part of a multi-step effort to increase 

oversight of Federal tax return 

preparers, Treasury and the IRS 

published regulations authorizing the 

IRS to require tax return preparers who 

prepare all or substantially all of a tax 

return for compensation after December 

31, 2010, to use PTINs as the preparer’s 

identifying number on all tax returns 

and refund claims that they prepare. On 

September 30, 2010, Treasury and the 

IRS published regulations that set the 

user fee for obtaining a PTIN at $50 plus 

a third-party vendor’s fee. On August 

23, 2010, Treasury and IRS published 

proposed amendments to Circular 230, 

which will establish registered tax 

return preparers as a new category of tax 

practitioner and will extend the ethical 

rules for tax practitioners to any 

individual who is a tax return preparer. 

Treasury and the IRS intend to finalize 

these regulations in 2010 or 2011 and 

publish additional guidance as 

necessary to implement the 

recommendations in the report. 

Requirement for Certain Taxpayers to 

File Forms Disclosing Uncertain Tax 

Positions. Section 6011 of the Internal 

Revenue Code provides that persons 

liable for a tax imposed by title 26 must 

make a return when required by 

regulations prescribed by the Secretary 

of the Treasury according to the forms 

and regulations prescribed by the 

Secretary. Treasury Regulation section 

1.6011-1 requires every person liable for 

income tax to make such returns as are 

required by regulation. Section 6012 

requires corporations subject to an 

income tax to make a return with 

respect to that tax. Treasury Regulation 

section 1.6012-2 sets out the 

corporations that are required to file 

returns and the form those returns must 

take. Treasury and the IRS issued 

proposed regulations on September 9, 

2010, that would require corporations to 

file a Schedule UTP consistent with the 

forms, instructions, and other 

appropriate guidance provided by the 

IRS. The IRS intends to implement the 

authority provided in this regulation 

initially by issuing a schedule and 

explanatory publication that require 

those corporations that prepare audited 

financial statements to file a schedule 

identifying and describing the uncertain 

tax positions, as described in FIN 48 

and other generally accepted accounting 

standards, that relate to the tax liability 

reported on the return. 

Basis Reporting. Section 403 of the 

Energy Improvement and Extension Act 

of 2008 (Pub. L. No. 110-343), enacted 

on October 3, 2008, added sections 

6045(g), 6045A, and 6045B to the 

Internal Revenue Code. Section 6045(g) 

provides that every broker required to 

file a return with the Service under 

section 6045(a) showing the gross 

proceeds from the sale of a covered 

security must include in the return the 

customer’s adjusted basis in the security 

and whether any gain or loss with 

respect to the security is long-term or 

short-term. Section 6045A further 

provides that, beginning in 2011, a 

broker and any other specified person 

(transferor) that transfers custody of a 

covered security to a receiving broker 

must furnish to the receiving broker a 

written statement that allows the 

receiving broker to satisfy the basis 

reporting requirements of section 

6045(g). The transferor must furnish the 

statement to the receiving broker within 

15 days after the date of the transfer or 

at a later time provided by the Secretary. 

Proposed regulations implementing 

these provisions and a notice of public 

hearing were published on December 

17, 2009, and a hearing was held on 

February 17, 2010. Final regulations and 

a Notice providing transitional relief 

from the transfer reporting requirements 

for calendar year 2011 were issued in 

October 2010. 

Withholding on Government Payments 

for Property and Services. Section 

3402(t) was added to the Internal 

Revenue Code by the Tax Increase 

Prevention and Reconciliation Act of 

2005 (TIPRA). Section 3402(t) requires 

all Federal, State, and local Government 

entities (except for certain small State 

entities) to deduct and withhold an 

income tax equal to 3 percent from all 

payments (with certain enumerated 

exceptions) the Government entity 

makes for property or services. Section 

3402(t) will be effective for payments 

made after December 31, 2011. On 

March 11, 2008, the IRS issued Notice 

2008-38 soliciting public comments 

regarding guidance to be provided to 

Federal, State, and local governments 

required to withhold under section 

3402(t). After considering the many 

comments, the IRS and Treasury issued 

a Notice of Proposed Rulemaking, 

which was published in the Federal 

Register on December 4, 2008. A hearing 

on the proposed regulations was held on 

April 16, 2009, and the IRS has received 

168 comments from stakeholders on the 

proposed regulations. The IRS and 

Treasury are considering the comments 

and intend to issue final regulations. 

Information Reporting for Foreign 

Accounts of U.S. Persons. In March 

2010, chapter 4 (sections 1471 to 1474) 

was added to subtitle A of the Internal 

Revenue Code as part of the Hiring 

Incentives to Restore Employment Act 

(HIRE Act) (Pub. L. 111-147). Chapter 4 

was enacted to address concerns with 

offshore tax evasion, and generally 

requires foreign financial institutions 

(FFIs) to enter into an agreement (FFI 

Agreement) with the IRS to report 

information regarding certain financial 

accounts of U.S. persons and foreign 


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entities with significant U.S. ownership. 

An FFI that does not enter into an FFI 

Agreement generally will be subject to 

a withholding tax on the gross amount 

of certain payments from U.S. sources, 

as well as the proceeds from disposing 

of certain U.S. investments. Treasury 

and the IRS published Notice 2010-60, 

which provides preliminary guidance 

and requests comments on the most 

important and time-sensitive issues 

under chapter 4. Treasury and the IRS 

expect to follow up this notice with 

proposed regulations, a proposed model 

FFI Agreement, and other guidance 

before the general effective date of 

chapter 4, which applies to payments 

made on or after January 1, 2013. This 

guidance will address numerous issues, 

notably the definition of FFI, the due 

diligence required of withholding agents 

and FFIs in identifying U.S. 

accountholders, and the requirements 

for reporting U.S. accounts. 

Withholding on Certain Dividend 

Equivalent Payments under Notional 

Principal Contracts. The HIRE act also 

added section 871(l) to the Code (now 

section 871(m)), which designates 

certain substitute dividend payments in 

security lending and sale-repurchase 

transactions and dividend-referenced 

payments made under certain notional 

principal contracts as U.S.-source 

dividends for purposes of the Federal 

withholding tax obligations of 

withholding agents and foreign persons 

(dividend equivalents). In response to 

this legislation, on May 20, 2010, the 

IRS issued Notice 2010-46, addressing 

the requirements for determining the 

proper withholding in connection with 

substitute dividends paid in foreign-toforeign security lending and salerepurchase transactions. The IRS and 

Treasury intend to issue regulations to 

implement the provisions of this Notice 

as well as regulations addressing cases 

where dividend equivalents should be 

found to arise in connection with 

notional principal contracts and other 

financial derivatives. 

Foreign Financial Asset Reporting 

(section 6038D). Section 6038D was 

enacted by section 511 of the HIRE Act, 

effective for taxable years beginning 

after March 18, 2010. Section 6038D 

requires an individual taxpayer to 

include a disclosure statement with the 

individual’s income tax return and to 

report certain information required by 

section 6038D(c) if the aggregate value 

of the taxpayer’s interests in specified 

foreign financial assets exceeds $50,000 

for the taxable year, or such higher 

dollar amount as the Secretary may 

prescribe. In addition, if a domestic 

entity is formed or availed of for the 

purpose of holding, directly or 

indirectly, specified foreign financial 

assets, then the Secretary may require 

the domestic entity to comply with 

section 6038D and report its specified 

foreign financial assets in the same 

manner as if the domestic entity were an 

individual. Treasury and the IRS intend 

to issue regulations, as well as a form 

and instructions, to implement section 

6038D. 

New International Tax Provisions of the 

Education, Jobs and Medicaid 

Assistance Act. On August 10, 2010, the 

Education, Jobs, and Medicaid 

Assistance Act of 2010 (Pub L. 111-226) 

was signed into law. The new law 

includes a significant package of 

international tax provisions. These 

provisions include limitations on the 

availability of foreign tax credits in 

certain cases where U.S. tax law and 

foreign tax law provide different rules 

for recognizing income and gain, and in 

cases where income items treated as 

foreign source under certain tax treaties 

would otherwise be sourced in the 

United States. The legislation also limits 

the ability of multinationals to reduce 

their U.S. tax burdens by using a 

provision intended to prevent 

corporations from avoiding U.S. income 

tax on repatriated corporate earnings. 

Other new provisions under this 

legislation limit the ability of 

multinational corporations to use 

acquisitions of related party stock to 

avoid U.S. tax on what would otherwise 

be taxable distributions of dividends. 

The statute also includes a new 

provision intended to tighten the rules 

under which interest expense is 

allocated between U.S.- and foreignsource income within multinational 

groups of related corporations when a 

foreign corporation has significant 

amounts of U.S.-source income that is 

effectively connected with a U.S. 

business. Treasury and the IRS expect to 

issue regulatory guidance on most of 

these provisions. 

Guidance on Tax-Related Health Care 

Provisions. On March 23, 2010, the 

President signed the Patient Protection 

and Affordable Care Act of 2010 (Pub. 

L. 111-148) and on March 30, 2010, the 

President signed the Health Care and 

Education Reconciliation Act of 2010 

(Pub. L. 111-152) (referred to 

collectively as the Affordable Care Act 

(ACA)). The ACA’s comprehensive 

reform of the health insurance system 

affects individuals, families, employers, 

health care providers, and health 

insurance providers. The ACA provides 

authority for Treasury and the IRS to 

issue regulations and other guidance to 

implement tax provisions in the ACA, 

some of which are effective immediately 

and some of which will become 

effective over the next several years. In 

the past few months, Treasury and the 

IRS, together with the Department of 

Health and Human Services and the 

Department of Labor, have issued a 

series of temporary and proposed 

regulations implementing various 

provisions of the ACA related to 

individual and group market reforms. In 

addition, Treasury and the IRS have 

issued guidance on specific ACA 

provisions relating to the tax treatment 

of health care benefits provided to 

children under age 27 (sec. 105 of the 

Code), the credit for small employers 

that provide health insurance coverage 

(sec. 45R), the credit for qualifying 

therapeutic discovery projects (sec. 

48D), additional requirements for taxexempt hospitals (sec. 501(r)), the tax on 

indoor tanning services (sec. 5000B), 

and information reporting for payments 

to corporations (sec. 6041). Providing 

additional guidance to implement tax 

provisions of the ACA is a priority for 

Treasury and the IRS. 

Office of the Comptroller of the 

Currency 

The Office of the Comptroller of the 

Currency (OCC) was created by 

Congress to charter national banks, to 

oversee a nationwide system of banking 

institutions, and to assure that national 

banks are safe and sound, competitive 

and profitable, and capable of serving in 

the best possible manner the banking 

needs of their customers. 

The OCC seeks to assure a banking 

system in which national banks soundly 

manage their risks, maintain the ability 

to compete effectively with other 

providers of financial services, meet the 

needs of their communities for credit 

and financial services, comply with 

laws and regulations, and provide fair 

access to financial services and fair 

treatment of their customers. 

The Dodd-Frank Wall Street Reform 

and Consumer Protection Act (Pub. L. 

111-203, 124 Stat. 1376, July 21, 2010) 

imposes a significant number of 

rulemaking requirements that must be 

completed during fiscal year 2011. Most 

of them are to be issued jointly with 

other agencies. The exact details and 

timing of the rulemakings have not yet 

been determined and, therefore, they are 

not included here or in our regulatory 

agenda. When more information is 

known, we will promptly add them to 

our regulatory agenda and report them 

in our fiscal year 2012 regulatory plan. 


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Significant rules issued during fiscal 

year 2010 include: 

• Risk-Based Capital Guidelines; 

Capital Adequacy Guidelines; Capital 

Maintenance; Capital — Residential 

Mortgage Loans Modified Pursuant to 

the Making Home Affordable Program 

(12 CFR part 3). In order to support 

and facilitate the timely 

implementation of the Making Home 

Affordable Plan (MHAP) announced 

by the U.S. Department of Treasury 

and to promote the stability of 

banking organizations and the 

financial system, the banking agencies 

issued a final rule providing that a 

residential mortgage loan (whether a 

first-lien or a second-lien loan) 

modified under the MHAP will retain 

the risk weight assigned to the loan 

prior to the modification, so long as 

the loan continues to meet other 

relevant supervisory criteria. The rule 

minimizes disincentives to bank 

participation in the MHAP that could 

otherwise result from agencies’ 

regulatory capital regulations. The 

banking agencies believe that this 

treatment is appropriate in light of the 

overall important public policy 

objectives of promoting sustainable 

loan modifications for at-risk 

homeowners that balance the interests 

of borrowers, servicers, and investors. 

Joint agency action was essential to 

ensure that the regulatory capital 

consequences of participation in the 

MHAP are the same for all 

commercial banks and thrifts. A final 

rule was issued on November 20, 

2009. (74 FR 60137) 

• Risk-Based Capital Guidelines; 

Capital Adequacy Guidelines; Capital 

Maintenance: Regulatory Capital; 

Impact of Modifications to Generally 

Accepted Accounting Principles; 

Consolidation of Asset-Backed 

Commercial Paper Programs; and 

Other Related Issues (12 CFR part 3). 

The Federal banking agencies 

amended their general risk-based and 

advanced risk-based capital adequacy 

frameworks by adopting a final rule 

that eliminates the exclusion of 

certain consolidated asset-backed 

commercial paper programs from riskweighted assets; provides for an 

optional two-quarter implementation 

delay followed by an optional twoquarter partial implementation of the 

effect on risk-weighted assets that will 

result from changes to U.S. generally 

accepted accounting principles 

pertaining to the transfer and 

consolidation assets; provides for an 

optional two-quarter delay, followed 

by an optional two-quarter phase-in, 

of the application of the agencies’ 

regulatory limit on the inclusion of 

the allowance for loan and lease 

losses (ALLL) in tier 2 capital for the 

portion of the ALLL associated with 

the assets a banking organization 

consolidates as a result of changes to 

U.S. generally accepted accounting 

principles; and provides a reservation 

of authority to permit the agencies to 

require a banking organization to treat 

entities that are not consolidated 

under accounting standards as if they 

were consolidated for risk-based 

capital purposes, commensurate with 

the risk relationship of the banking 

organization to the structure. The 

delay and subsequent phase-in 

periods of the implementation apply 

only to the agencies’ risk-based 

capital requirements, not the leverage 

ratio requirement. This final rule was 

issued on January 28, 2010 (75 FR 

4636). 

• Registration of Mortgage Loan 

Originators (12 CFR part 34). The 

banking agencies, the NCUA, and 

Farm Credit Administration (FCA) 

issued final rules to implement the 

S.A.F.E. Mortgage Licensing Act of 

2008, title V of the Housing and 

Economic Recovery Act of 2008, 

Public Law 110-289. These 

amendments require an employee of a 

depository institution, an employee of 

a depository institution subsidiary 

regulated by a Federal banking 

agency, or an employee of an 

institution regulated by the FCA who 

engages in the business of a mortgage 

loan originator to register with the 

Nationwide Mortgage Licensing 

System and Registry (NMLSR) and to 

obtain a unique identifier. These 

amendments also provide that these 

institutions must require their 

employees who act as mortgage loan 

originators to comply with this Act’s 

registration and unique identifier 

requirements and must adopt and 

follow written policies and 

procedures to assure compliance with 

these requirements. The final rules 

were issued on July 28, 2010 (75 FR 

44656). The OCC has included this 

rulemaking project in The Regulatory 

Plan (1557-AD23). 

• Community Reinvestment Act 

Regulations (12 CFR part 25). The 

banking agencies issued proposed 

regulations to revise provisions of 

their rules implementing the 

Community Reinvestment Act. The 

agencies proposed revising the term 

‘‘community development’’ to include 

loans, investments, and services by 

financial institutions that support, 

enable or facilitate projects or 

activities that meet the criteria 

described in section 2301(c)(3) of the 

Housing and Economic Recovery Act 

of 2008 (HERA) and are conducted in 

designated target areas identified in 

plans approved by the U.S. 

Department of Housing and Urban 

Development under the Neighborhood 

Stabilization Program (NSP), 

established by HERA. This notice of 

proposed rulemaking was published 

on June 24, 2010 (75 FR 36016). 

• Community Reinvestment Act 

Regulations (12 CFR part 25). On 

August 14, 2008, the Higher 

Education Opportunity Act (HEOA) 

was enacted into law (Pub. L. 110- 

315, 122 Stat. 3078). Section 1031 of 

the HEOA revised the Community 

Reinvestment Act (CRA) to require the 

banking agencies, when evaluating a 

bank’s record of meeting community 

credit needs, to consider, as a factor, 

low-cost education loans provided by 

the bank to low-income borrowers. 

The banking agencies issued a final 

rule that would implement section 

1031 of the HEOA. In addition, the 

rule would incorporate into the 

banking agencies’ rules statutory 

language that allows them to consider 

as a factor when evaluating a bank’s 

record of meeting community credit 

needs capital investment, loan 

participation, and other ventures 

undertaken by nonminority- and 

nonwomen-owned financial 

institutions in cooperation with 

minority- and women-owned 

financial institutions and low-income 

credit unions. The joint final rule was 

published on October 4, 2010 (75 FR 

61046) 

• Alternatives to the Use of External 

Credit Ratings in the Regulations of 

the OCC (12 CFR parts 1, 16, and 28). 

Section 939A of the Dodd-Frank Wall 

Street Reform and Consumer 

Protection Act directs all Federal 

agencies to review, no later than one 

year after enactment, any regulation 

that requires the use of an assessment 

of credit-worthiness of a security or 

money market instrument and any 

references to or requirements in 

regulations regarding credit ratings. 

The agencies are also required to 

remove references or requirements of 

reliance on credit ratings and to 

substitute an alternative standard of 

credit-worthiness. Through an 

advanced notice of proposed 

rulemaking (ANPRM), the OCC is 

seeking to gather information as it 

begins to review its regulations 

pursuant to the Dodd-Frank Act. This 


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79634 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

ANPRM describes the areas where the 

OCC’s regulations, other than those 

that establish regulatory capital 

requirements, currently rely on credit 

ratings; sets forth the considerations 

underlying such reliance; and 

requests comment on potential 

alternatives to the use of credit 

ratings. The ANPRM was published 

on August 13, 2010 (75 FR 49423). 

• Advance Notice of Proposed 

Rulemaking Regarding Alternatives to 

the Use of Credit Ratings in the RiskBased Capital Guidelines of the 

Federal Banking Agencies (12 CFR 

part 3). Section 939A of the DoddFrank Wall Street Reform and 

Consumer Protection Act directs all 

Federal agencies to review, no later 

than 1 year after enactment, any 

regulation that requires the use of an 

assessment of credit-worthiness of a 

security or money market instrument 

and any references to or requirements 

in regulations regarding credit ratings. 

The agencies are also required to 

remove references or requirements of 

reliance on credit ratings and to 

substitute an alternative standard of 

credit-worthiness. Through an 

advanced notice of proposed 

rulemaking, the Federal banking 

agencies are seeking to gather 

information as they begin to review 

their regulations and capital standards 

pursuant to the Dodd-Frank Act. This 

ANPRM describes the areas in the 

agencies’ risk-based capital standards 

(including the general risk-based 

capital rules, market risk rules, and 

advanced approaches rules) where the 

agencies rely on credit ratings, as well 

as the Basel Committee on Banking 

Supervision’s recent amendments to 

the Basel Accord, which could affect 

those standards. The ANPRM then 

requests comment on potential 

alternatives to the use of credit 

ratings. The ANPRM was published 

on August 25, 2010 (75 FR 52283). 

The OCC’s regulatory priorities for 

fiscal year 2011 include the following: 

• Standards Governing the Release of a 

Suspicious Activity Report (12 CFR 

part 4). Confidentiality of Suspicious 

Activity Reports (12 CFR part 21). 

The OCC is issuing final regulations 

governing the release of non-public OCC 

information set forth in 12 CFR part 4, 

subpart C. The final rule clarifies that 

the OCC’s decision to release a 

suspicious activity report (SAR) will be 

governed by the standards set forth in 

amendments to the OCC’s SAR 

regulation, 12 CFR 21.11(k), that are part 

of a separate, but simultaneously issued, 

final rulemaking discussed below. 

The OCC’s final regulations 

implementing the Bank Secrecy Act 

governing the confidentiality of a 

suspicious activity report (SAR) will: 

Clarify the scope of the statutory 

prohibition on the disclosure by a 

national bank of a SAR; address the 

statutory prohibition on the disclosure 

by the government of a SAR as that 

prohibition applies to the OCC’s 

standards governing the disclosure of 

SARs; clarify that the exclusive standard 

applicable to the disclosure of a SAR, or 

any information that would reveal the 

existence of a SAR, by the OCC is ‘‘to 

fulfill official duties consistent with the 

purposes of the BSA’’; and modify the 

safe harbor provision in its rules to 

include changes made by the USA 

PATRIOT Act. This final rule is based 

upon a similar rule prepared by the 

Financial Crimes Enforcement Network 

(FinCEN). 

• Collective Investment Funds (12 CFR 

part 9). The OCC plans to develop and 

issue a notice of proposed rulemaking 

to update the regulation of short term 

investment funds (STIFs). The 

proposal would seek comment on: A 

proposed requirement for STIFs to 

adopt a stable Net Asset Value (NAV) 

as a fund objective; a shortened 

period for securities maturities, 

liquidity standards, and a contingency 

funding plan; proposed stress testing 

of funds; a proposal to compare NAV 

to market value, contingency plans, 

and actions to be taken at certain 

variances between NAV and market 

value; proposed disclosures to fund 

participants; and a proposed bank 

notification to the OCC if certain 

events impact a STIF. 

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 (OCC), the Board of 

Governors of the Federal Reserve 

System (FRB), and the Federal Deposit 

Insurance Corporation (FDIC) 

(collectively, the banking agencies) 

continue to work together on regulations 

where they share the responsibility to 

implement statutory requirements. The 

banking agencies currently are working 

jointly on rules to implement provisions 

in the Dodd-Frank Wall Street Reform 

and Consumer Protection Act (DoddFrank) and to update capital standards 

to maintain and improve consistency in 

agency rules. These rules include 

revisions to implement the International 

Convergence of Capital Management 

and Capital Standards: A Revised 

Framework (Basel II Framework) and 

include: 

• Risk-Based Capital Standards: Market 

Risk: In 2006, the banking agencies 

issued an NPRM on Market Risk. In 

the NPRM, OTS proposed to require 

savings associations to measure and 

hold capital to cover their exposure to 

market risk. The banking agencies did 

not finalize the 2006 NPRM. 

Subsequently, the Basel Committee 

directed international revisions, 

which were completed in July 2009. 

At that time, the banking agencies 

began drafting a new NPRM based 

upon the international revisions, as 

well as on the comments received on 

the 2006 NPRM. The banking agencies 

plan to issue a new NPRM in 2011. 

• Risk-Based Capital Standards: 

Standardized Approach: In 2008, the 

banking agencies issued an NPRM 

implementing the Standardized 

Approach to credit risk and 

approaches to operational risk that are 

contained in the Basel II Framework. 

Banking organizations would be able 

to elect to adopt these proposed 

revisions or remain subject to the 

agencies’ existing risk-based capital 

rules, unless the banking organization 

uses the Advanced Capital Adequacy 

Framework. The banking agencies are 

considering how best to move forward 

in adopting this proposal, particularly 

in light of section 939A of the DoddFrank Act, which directs Federal 

agencies to review their regulations 

that reference or require the use of 

credit ratings to assess the 

creditworthiness of an instrument and 

replace such references with uniform 

standards of creditworthiness. 

• Risk-Based Capital Standards: 

Alternatives to the Use of Credit 

Ratings. The banking agencies are 

seeking to gather information as they 

begin work toward revising their 

capital regulations to comply with the 

Dodd-Frank Act. Section 939A of the 

Act directs all Federal agencies to 

review their regulations that reference 

or require the use of credit ratings to 


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assess the creditworthiness of an 

instrument. The Act further directs 

the agencies to remove such 

requirements and to substitute in their 

place uniform standards of 

creditworthiness. 

• Excessive Incentive-Based 

Compensation; Compensation 

Structure Disclosure: Section 956 of 

the Dodd-Frank Act requires the 

banking agencies, the National Credit 

Union Administration (NCUA), the 

Securities and Exchange Commission 

(SEC), and the Federal Housing 

Finance Agency, to jointly prescribe 

regulations or guidance prohibiting 

any types of incentive-based payment 

arrangement, or any feature of any 

such arrangement, that the regulators 

determine encourages inappropriate 

risks by covered financial institutions 

by providing an executive officer, 

employee, director, or principal 

shareholder with excessive 

compensation, fees, or benefits, or 

that could lead to material financial 

loss to the covered financial 

institution. The Act also requires such 

agencies to jointly prescribe 

regulations or guidance requiring each 

covered financial institution to 

disclose to its regulator the structure 

of all incentive-based compensation 

arrangements offered by such 

institution sufficient to determine 

whether the compensation structure 

provides any officer, employee, 

director, or principal shareholder 

with excessive compensation or could 

lead to material financial loss to the 

institution. 

In addition to the interagency riskbased capital regulatory project 

involving alternatives to the use of 

credit ratings referenced above, OTS 

also will undertake: 

• Alternatives to the Use of External 

Credit Ratings in the Regulations of 

the OTS: Pursuant to the requirements 

of section 939 of the Dodd-Frank Act, 

OTS will review any non-capital 

regulation that requires the use of an 

assessment of creditworthiness of a 

security or money market instrument 

and any references to or requirements 

in regulations regarding credit ratings, 

and will remove references to or 

requirements of reliance on credit 

ratings and will substitute an 

alternative standard of 

creditworthiness. 

OTS is also working on joint 

rulemakings with the OCC, FRB, and 

FDIC to implement regulations related 

to other statutes, including the 

Community Reinvestment Act (CRA) 

and the Gramm-Leach-Bliley Act 

(GLBA): 

• CRA Higher Education Loans final 

rule: The banking agencies published 

a proposed rule on June 30, 2009, to 

implement section 1031 of the Higher 

Education Opportunity Act, which 

requires the agencies, when 

evaluating an institution’s record of 

meeting community credit needs to 

consider, as a factor, low-cost 

education loans provided by the 

institution to low-income borrowers 

(74 FR 31209). The banking agencies 

plan to issue a final rule in the fall of 

2010. 

• CRA Neighborhood Stabilization 

Program (NSP) final rule: On June 24, 

2010, the banking agencies published 

a proposed rule to revise the term 

‘‘community development’’ to include 

loans, investments, and services by 

institutions that support, enable, or 

facilitate projects or activities that 

meet the criteria described in section 

2301(c)(3) of the Housing and 

Economic Recovery Act of 2008 and 

are conducted in designated target 

areas identified in plans approved by 

the U.S. Department of Housing and 

Urban Development under the NSP 

(75 FR 36016). The agencies plan to 

issue a final rule in the fall of 2010. 

• Recordkeeping Requirements for 

Securities Activities, Joint Notice of 

Proposed Rulemaking: The GLBA 

requires the banking agencies to adopt 

recordkeeping requirements sufficient 

to facilitate and demonstrate 

compliance with the exceptions to the 

definitions of ‘‘broker’’ or ‘‘dealer’’ for 

banks in the Securities Exchange Act 

of 1934. The banking agencies plan to 

issue the NPRM in the fall of 2010. 

Significant final rules issued by OTS 

during fiscal year 2010 include: 

• Risk-Based Capital Guidelines: 

Impact of Modifications to Generally 

Accepted Accounting Principles; 

Consolidation of Asset-Backed 

Commercial Paper Programs. On 

January 28, 2010 (75 FR4636), the 

banking agencies modified their 

general risk-based capital standards 

and advanced risk-based capital 

adequacy framework to eliminate the 

exclusion of certain consolidated 

asset-backed commercial paper 

programs from risk-weighted assets; 

and permit the banking agencies to 

require banking organizations to treat 

structures that are not consolidated 

under accounting standards as if they 

were consolidated for risk-based 

capital purposes commensurate with 

the risk relationship of the banking 

organization to the structure. 

• S.A.F.E. Mortgage Licensing: The 

banking agencies, the NCUA, and the 

Farm Credit Administration issued a 

joint final rule on July 28, 2010, to 

amend their rules to implement the 

Secure and Fair Enforcement for 

Mortgage Licensing Act (the S.A.F.E. 

Act) (75 FR 44656). These 

amendments require an employee of a 

depository institution or a depository 

institution subsidiary regulated by a 

Federal banking agency, or an 

employee of an institution regulated 

by the NCUA or FCA, that engages in 

the business of a mortgage loan 

originator to register with the 

Nationwide Mortgage Licensing 

System and Registry and to obtain a 

unique identifier. The amendments 

also provide that these regulated 

institutions must require their 

employees who act as mortgage loan 

originators to comply with the 

S.A.F.E. Act’s registration and unique 

identifier requirements and must 

adopt and follow written policies and 

procedures to assure compliance with 

such requirements. 

• Privacy Notices: On December 1, 

2009, OTS implemented section 728 

of the Financial Services Regulatory 

Relief Act of 2006 by amending its 

privacy rules under the GLBA to 

include a safe harbor model privacy 

form (74 FR 62894). The banking 

agencies, the SEC, the Federal Trade 

Commission, and the Commodities 

Futures Trading Commission issued 

final amendments to their rules 

requiring that initial and annual 

privacy notices be sent to their 

customers. And, pursuant to section 

728, the banking agencies adopted a 

model privacy form that financial 

institutions may rely on as a safe 

harbor to provide disclosures under 

the privacy rules. 

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 

alcohol, tobacco, firearms, and 

ammunition taxes and relating to 

commerce involving alcohol beverages. 

TTB’s mission and regulations are 

designed to: 

1) Regulate with regard to the issuance 

of permits and authorizations to 

operate in the alcohol and tobacco 

industries; 

2) Assure the collection of all alcohol, 

tobacco, and firearms and 


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ammunition taxes, and obtain a high 

level of voluntary compliance with all 

laws governing those industries; and 

3) Suppress commercial bribery, 

consumer deception, and other 

prohibited practices in the alcohol 

beverage industry. 

TTB plans to pursue one significant 

regulatory action during FY 2011. In 

2007, the Department approved the 

publication of a notice of proposed 

rulemaking soliciting comments on a 

proposal to require a serving facts 

statement on alcohol beverage labels. 

The proposed statement would include 

information about the serving size, the 

number of servings per container, and 

per-serving information on calories and 

grams of carbohydrates, fat, and protein. 

The proposed rule would also require 

information about alcohol content. This 

regulatory action was initiated under 

section 105(e) of the Federal Alcohol 

Administration Act, 27 U.S.C. 205(e), 

which confers on the Secretary of the 

Treasury authority to promulgate 

regulations for the labeling of alcoholic 

beverages, including regulations that 

prohibit consumer deception and the 

use of misleading statements on labels 

and that ensure that such labels provide 

the consumer with adequate 

information as to the identity and 

quality of the product. TTB anticipates 

publication of a final rule in FY 2011. 

In addition to the regulatory action 

described above, in FY 2011, TTB plans 

to give priority to the following 

regulatory matters: 

Modernization of title 27, Code of 

Federal Regulations. TTB will continue 

to pursue its multi-year program of 

modernizing its regulations in title 27 of 

the Code of Federal Regulations (CFR). 

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 parts in chapter I of title 27 

of the CFR and prioritized them as 

‘‘high,’’ ‘‘medium,’’ or ‘‘low’’ in terms of 

the need for complete revision or 

regulation modernization. TTB 

determined importance based on 

industry member numbers, revenue 

collected, and enforcement and 

compliance issues identified through 

field audits and permit qualifications, 

statutory changes, significant industry 

innovations, and other factors. The 10 

parts of title 27 of the CFR 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 parts represent 

nearly all the tax revenue that TTB 

collects. The remaining five parts rated 

‘‘high’’ consist of regulations covering 

imports and exports (part 27— 

Importation of Distilled Spirits, Wines, 

and Beer; part 28—Exportation of 

Alcohol; and part 44—Exportation of 

Tobacco Products and Cigarette Papers 

and Tubes, Without Payment of Tax, or 

With Drawback of Tax), as well as 

regulations addressing the American 

Viticultural Area program (part 9) and 

TTB procedures (part 70). 

To date, related to the modernization 

plan, TTB has published notices of 

proposed rulemaking to revise part 19 

and to amend part 9 and has reviewed 

the public comments received in 

response to those notices. TTB also 

plans to put forward to the Department 

for publication approval an advance 

notice of proposed rulemaking 

(ANPRM) for the revision of the beer 

regulations in part 25. We anticipate 

that the final rules for parts 9 and 19 

and the ANPRM for part 25 will be 

published in FY 2011. In FY 2011, TTB 

will begin a modernization effort on the 

export regulations in part 28 and a 

crosscutting modernization effort to 

incorporate statutory changes into the 

regulations. 

Allergen Labeling. In FY 2006, TTB 

published interim regulations setting 

forth standards for voluntary allergen 

labeling of alcohol beverages. These 

regulatory changes were an outgrowth of 

changes made to the Federal Food, 

Drug, and Cosmetic Act by the Food 

Allergen Labeling and Consumer 

Protection Act of 2004. At the same 

time, TTB published a proposal to make 

those interim requirements mandatory. 

In FY 2011, TTB will continue its 

review of mandatory allergen labeling 

with a view to preparing a final rule 

document that would take effect on the 

same date as the serving facts regulatory 

changes discussed above. 

Other Wine Labeling Issues. In FY 2011, 

TTB will continue to act on petitions for 

the establishment of new American 

viticultural areas (AVAs) and for the 

modification of the boundaries of 

existing AVAs. TTB also will seek 

Departmental publication approval of a 

number of other wine labeling 

rulemaking documents for public 

comment in FY 2011, including a notice 

of proposed rulemaking to adopt new 

label designation standards for wines 

now generally described as ‘‘wine with 

natural flavors,’’ and an advance notice 

of proposed rulemaking seeking 

comments on a petition requesting that 

the regulations be amended to limit the 

use of American appellations to wines 

produced entirely from U.S. grapes. 

Specially Denatured and Completely 

Denatured Alcohol Formulas. In FY 

2011, TTB will submit for publication 

approval by the Department a proposal 

to reclassify some specially denatured 

alcohol (SDA) formulas as completely 

denatured alcohol (CDA) for which 

formula submission to TTB is not 

required. The proposed regulatory 

changes would also allow other SDA 

formulas to be used without the 

submission of article formulas. These 

changes would allow TTB to shift its 

SDA-dedicated resources from the 

current front-end pre-market formula 

control approach to a post-market 

assessment of actual compliance with 

SDA regulations. 

Alternation of Brewery Premises. In FY 

2011, TTB will forward to the 

Department for publication approval a 

notice of proposed rulemaking to amend 

the TTB regulations to set forth specific 

standards for the approval and 

operation of alternating proprietorships 

at the same brewery premises. The 

proposed regulations will include 

standards for alternation agreements 

between host and tenant brewers as well 

as rules for recordkeeping and 

segregation of products made by 

different brewers. 

Classification of Tobacco Products. In 

FY 2011, TTB will continue its review 

of standards for the classification of 

different tobacco products. In FY 2010, 

TTB published an advance notice 

seeking comments on appropriate 

standards to distinguish between pipe 

tobacco and roll-your-own tobacco. TTB 

will review comments in 2011 and 

proceed with further rulemaking as 

appropriate. 

Bureau of the Public Debt 

The Bureau of the Public Debt (BPD) 

has responsibility for borrowing the 

money needed to operate the Federal 

Government and accounting for the 

resulting debt, regulating the primary 

and secondary Treasury securities 

markets, and ensuring that reliable 

systems and processes are in place for 

buying and transferring Treasury 

securities. 


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BPD administers regulations: (1) 

Governing transactions in government 

securities by government securities 

brokers and dealers under the 

Government Securities Act of 1986 

(GSA), as amended; (2) Implementing 

Treasury’s borrowing authority, 

including rules governing the sale and 

issue of savings bonds, marketable 

Treasury securities, and State and local 

government securities; (3) Setting out 

the terms and conditions by which 

Treasury may buy back and redeem 

outstanding, unmatured marketable 

Treasury securities through debt 

buyback operations; (4) Governing 

securities held in Treasury’s retail 

systems; and (5) Governing the 

acceptability and valuation of collateral 

pledged to secure deposits of public 

monies and other financial interests of 

the Federal Government. 

During fiscal year 2011, BPD will 

accord priority to the following 

regulatory projects: 

Savings Bond Issuing and Paying Agent 

Regulations. BPD plans to issue a final 

rule amending the savings bond issuing 

agent regulations (31 CFR part 317) to 

allow BPD to reduce the fee it pays 

issuing agents for submitting savings 

bond applications in paper form. 

TreasuryDirect. BPD is ending the sale 

of paper savings bonds through payroll 

savings plans. In October 2010, BPD 

anticipates a rulemaking that will add 

electronic payroll savings plans to 

TreasuryDirect. 

SellDirect. BPD plans to eliminate the 

SellDirect option from Legacy Treasury 

Direct and TreasuryDirect. The 

anticipated effective date for this 

rulemaking is December 31, 2010. 

Financial Management Service 

The Financial Management Service 

(FMS) issues regulations to improve the 

quality of Government financial 

management and to administer its 

payments, collections, debt collection, 

and Governmentwide accounting 

programs. For fiscal year 2011, FMS’ 

regulatory plan includes the following 

priorities: 

Management of Federal Agency 

Disbursements. We are amending our 

regulation that describes the 

responsibilities of Federal agencies and 

recipients with respect to the electronic 

delivery of Federal payments and 

establishes the circumstances under 

which waivers from the electronic funds 

transfer (EFT) requirement are available. 

Federal law requires that, unless waived 

by the Secretary of the Treasury, all 

Federal payments, other than payments 

made under the Internal Revenue Code 

of 1986, must be made electronically, 

that is, by EFT. The amendments 

generally require individuals to receive 

Federal nontax payments by EFT, 

effective March 1, 2011. Individuals 

receiving Federal payments by check on 

the effective date, however, may 

continue to do so until February 28, 

2013. 

For Federal benefit recipients, this 

means that individuals who apply for 

Federal benefits on or after March 1, 

2011, would receive their benefit 

payments by direct deposit. Individuals 

who do not choose direct deposit of 

their payments to an account at a 

financial institution would be enrolled 

in the Direct Express® Debit 

MasterCard® card program, a prepaid 

card program established pursuant to 

terms and conditions approved by FMS. 

Beginning on March 1, 2013, all 

recipients of Federal benefit and other 

non-tax payments would receive their 

payments by direct deposit, either to a 

bank account or to a Direct Express®

card account. 

Federal Government Participation in the 

Automated Clearing House. We are 

amending our regulation governing the 

use of the Automated Clearing House 

(ACH) system by Federal agencies. The 

amendments adopt, with some 

exceptions, the ACH Rules developed 

by NACHA—The Electronic Payments 

Association (NACHA), as the rules 

governing the use of the ACH Network 

by Federal agencies. We are issuing this 

rule to address changes that NACHA has 

made to the ACH Rules since the 

publication of NACHA’s 2007 ACH 

Rules book. These changes include new 

requirements to identify all 

international payment transactions 

using a new Standard Entry Class Code 

and to include certain information in 

the ACH record sufficient to allow the 

receiving financial institution to 

identity the parties to the transaction 

and to allow transactions to be screened 

for compliance with for Office of 

Foreign Assets Control (OFAC) 

requirements. 

In addition, the amendments will: (1) 

Streamline the process for reclaiming 

post-death benefit payments from 

financial institutions; (2) require 

financial institutions to provide limited 

account-related customer information 

related to the reclamation of post-death 

benefit payments as permitted under the 

Payment Transactions Integrity Act of 

2008; and (3) modify our previous 

guidance regarding the requirement that 

non-vendor payments be delivered to a 

deposit account in the name of the 

recipient. 

Indorsement and Payment of Checks 

Drawn on the United States Treasury. 

By amending our regulation governing 

the indorsement and payment of checks 

drawn on the United States Treasury, 

we will provide Treasury with authority 

to debit a financial institution’s reserve 

account at the financial institution’s 

servicing Federal Reserve Bank for all 

check reclamations that the financial 

institution has not protested. Financial 

institutions will continue to have the 

right to file a protest with FMS if they 

believe a proposed reclamation is in 

error. 

Debt Collection Authorities Under the 

Debt Collection Improvement Act. We 

are amending our regulation governing 

the offset of Federal tax refunds to 

collect delinquent State income tax 

obligations. The SSI Extension for 

Elderly and Disabled Refugees Act of 

2008 amended section 6402 of the 

Internal Revenue Code to authorize the 

offset of Federal tax refunds to collect 

certain delinquent unemployment 

compensation debts owed to States by 

taxpayers. Treasury will incorporate the 

procedures necessary to collect State 

unemployment compensation debts 

reported by States as part of our 

centralized Treasury Offset Program. 

Domestic Finance 

Office of the Fiscal Assistant Secretary 

(OFAS) 

The Office of the Fiscal Assistant 

Secretary develops policy for and 

oversees the operations of the financial 

infrastructure of the Federal 

Government, including payments, 

collections, cash management, 

financing, central accounting, and 

delinquent debt collection. 

Anti-Garnishment. On April 19, 2010, 

Treasury issued a joint proposed rule 

with the Office of Personnel 

Management, the Railroad Retirement 

Board, the Social Security 

Administration, and Veterans Affairs. 

Treasury plans to promulgate a final 

joint rule, with the Federal benefit 

agencies, to give force and effect to 

various benefit agency statutes that 

exempt Federal benefits from 

garnishment. Typically, upon receipt of 

a garnishment order from a State court, 

financial institutions will freeze an 

account as they perform due diligence 

in complying with the order. The joint 

rule will address this practice of 

account freezes to ensure that benefit 

recipients have access to a certain 

amount of lifeline funds, while 

garnishment orders or other legal 


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processes are resolved or adjudicated, 

and will provide financial institutions 

with specific administrative instructions 

to carry out upon receipt of a 

garnishment order. The joint rule will 

apply to financial institutions but is not 

expected to have specific provisions for 

consumers, debt collectors, or banking 

regulators. However, the banking 

regulators would enforce the policy in 

cases of noncompliance by means of 

their general authorities. 

Small Business Jobs Act 

The Small business Jobs Act created 

two programs that Treasury is 

implementing during FY2011. First, the 

Act established the Small Business 

Lending Fund, a $30 billion fund to 

help small and community banks 

provide new loans to small businesses. 

The Act also established the State Small 

Business Credit Initiative, which 

provides funding to strengthen state 

small business lending programs. As 

required by the Act, Treasury expects 

issue guidance and regulations to 

implement these programs. 

Federal Insurance Office (FIO) 

Title V of the Dodd-Frank Wall Street 

Reform and Consumer Protection Act 

(‘‘Dodd-Frank’’ or ‘‘Act’’) established the 

Federal Insurance Office (FIO) with the 

Department of the Treasury. FIO will 

provide the federal government with 

dedicated expertise regarding the 

insurance industry. The Office will 

monitor the insurance industry, 

including identifying gaps or issues in 

the regulation of insurance that could 

contribute to a systemic crisis in the 

insurance industry or the United States 

financial system. FIO may receive and 

collect data and information on and 

from the insurance industry and 

insurers, enter into information-sharing 

agreements, analyze and disseminate 

data and information, and issue reports 

and regulations. 

Office of Financial Research 

Title I, Subtitle B of the Dodd-Frank 

Wall Street Reform and Consumer 

Protection Act (Pub. L. 111-203) 

(‘‘Dodd-Frank Act’’) establishes the 

Office of Financial Research (OFR). The 

OFR is an office within the Department 

of the Treasury and will be headed by 

a Director, appointed by the President, 

by and with the advice and consent of 

the Senate. Congress created the OFR to 

help facilitate financial market data 

gathering and analyses for the new 

Financial Stability Oversight Council 

(FSOC), which is responsible for 

monitoring the financial system as a 

whole in order to promote financial 

stability and for the member agencies of 

the FSOC. Section 153(c) of the DoddFrank Act provides that the OFR ‘‘shall 

issue rules, regulations, and orders’’ to 

carry out specified purposes and duties 

under the Act. 

BILLING CODE 4810–25–S 


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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 highquality 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. 

BILLING CODE 8320–01–S 


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ENVIRONMENTAL PROTECTION 

AGENCY (EPA) 

Statement of Priorities 

Overview 

Created in the wake of elevated 

concern about environmental pollution, 

the U.S. Environmental Protection 

Agency opened its doors in downtown 

Washington, DC, on December 2, 1970. 

EPA was established to consolidate in 

one agency a variety of Federal research, 

monitoring, standard-setting, and 

enforcement activities to ensure 

environmental protection. EPA’s 

mission is to protect human health and 

to safeguard the natural environment— 

air, water, and land—upon which life 

depends. For the past 40 years, EPA has 

been working for a cleaner, healthier 

environment for the American people. 

From regulating vehicle emissions to 

ensuring that drinking water is safe; 

from cleaning up toxic waste to 

assessing the safety of pesticides and 

chemicals; and from reducing 

greenhouse gas emissions to 

encouraging conservation, reuse, and 

recycling, EPA and its Federal, State, 

local, and community partners have 

made enormous progress in protecting 

the Nation’s health and environment. 

Our air and water have both grown 

significantly cleaner in the last 40 years. 

The number of Americans receiving 

water that meets health standards went 

from 79 percent in 1993, to 92 percent 

in 2008. We have also reduced 60 

percent of the dangerous air pollutants 

that cause smog, acid rain, lead 

poisoning, and more since the passage 

of the Clean Air Act in 1970. 

Innovations like smokestack scrubbers 

and catalytic converters in automobiles 

have helped this process. Today, new 

cars are 98 percent cleaner in terms of 

smog-forming pollutants than they were 

in 1970. Meanwhile, American families 

and businesses went from recycling 

about 10 percent of trash in 1980 to 

more than 33 percent in 2008. Eightythree million tons of trash are recycled 

annually-the equivalent of cutting 

greenhouse gas emissions from more 

than 33 million automobiles. 

Highlights of EPA’s Regulatory Plan 

Despite the Nation’s progress, 

however, much work remains. The 

environmental problems the country 

faces today are often more complex than 

those of years past, and implementing 

solutions—both nationally and 

globally—are more challenging. 

Addressing global climate change will 

call for coordinated efforts to research 

alternative fuels and other emission 

reduction technologies and will require 

strong partnerships across many 

economic sectors and around the world. 

Increased energy consumption and 

higher costs underscore the need to 

promote alternative energy sources and 

invest in new technologies. EPA and 

States face serious challenges in 

improving and maintaining the Nation’s 

drinking water and wastewater 

infrastructure, and both are seeking 

innovative ways to fund needed repairs 

and construction. EPA remains 

committed to working with global 

partners to advance shared priorities, 

not only by adapting to climate change, 

but also in ensuring national security, 

facilitating commerce, promoting 

sustainable development, protecting 

vulnerable populations, and engaging 

diplomatically around the world. 

Deepwater BP Oil Spill 

EPA responded swiftly and 

transparently to the Deepwater BP oil 

spill in the Gulf of Mexico. The Agency 

has been working with local, State, and 

Federal response partners to provide 

sampling and real-time monitoring of 

the air, water, and sediment along the 

Gulf Coast. These efforts are intended to 

help States and other Federal agencies 

understand the immediate and longterm impacts of oil contamination and 

to ensure that residents in affected areas 

have access to information about the 

quality of their water. As part of its 

ongoing response, the Agency has 

developed new ways to provide the 

public with the latest data and 

information. EPA’s emergency response 

site (www.epa.gov/bpspill) has offered 

downloadable files with data on air, 

water, sediment, and waste conditions 

gathered since April 28th, just days after 

the spill. 

This spill has seriously affected the 

ecological and economic health of the 

Gulf Coast communities. Following the 

emergency response with a sustained, 

effective recovery and rebuilding effort 

will require significant commitments of 

resources, scientific and technical 

expertise, and coordination with a range 

of partners in the months and years 

ahead. 

Seven Guiding Priorities 

The Deepwater BP oil spill and other 

challenges inspire the Agency and drive 

its commitment to excellent 

performance and strong, measurable 

results. EPA is committed to carrying 

out its mission while respecting its core 

values of science, transparency, and the 

rule of law. Effective, consistent 

enforcement is critical to achieving the 

human-health and environmental 

benefits expected from our 

environmental laws. To guide the 

Agency’s efforts in 2011 and subsequent 

years, Administrator Lisa P. Jackson has 

established seven guiding priorities. 

1. Taking Action on Climate Change 

In 2009, EPA finalized an 

endangerment finding on greenhouse 

gases; issued the first national rules to 

reduce greenhouse gas emissions under 

the Clean Air Act; and initiated a 

national reporting system for 

greenhouse gas emissions. While EPA 

stands ready to help Congress craft 

strong, science-based climate legislation 

that addresses the spectrum of issues, 

the Agency will deploy existing 

regulatory tools as they are available 

and warranted. Using the Clean Air Act, 

EPA will finalize mobile source rules 

and provide a framework for continued 

improvements in that sector. In 2011, 

EPA will further develop the national 

reporting system for greenhouse gases to 

enable the agency to receive, qualityassure, and verify data submitted 

electronically from 10,000 to 15,000 

covered facilities. EPA will also 

continue to develop common-sense 

solutions for reducing greenhouse gas 

emissions from large stationary sources 

like power plants. In all of this, EPA is 

committed to recognizing that climate 

change affects other parts of its core 

mission. 

Greenhouse Gas Emissions Standards 

for Automobiles. Last year, EPA took the 

first Federal regulatory steps to address 

the problem of global climate change by 

requiring industries to report their 

greenhouse gas emissions, and by 

issuing regulations that reduce 

greenhouse emissions from cars and 

light trucks and increase the Nation’s 

use of renewable fuels. Transportation 

sources emitted 28 percent of all U.S. 

greenhouse gas emissions in 2007 and 

have been the fastest-growing source of 

those emissions since 1990. This year 

EPA is taking another major step by 

proposing to set national emissions 

standards under section 202 of the 

Clean Air Act to control greenhouse gas 

emissions from heavy-duty trucks and 

buses. 

Prevention of Significant 

Deterioration. In January 2011, EPA will 

begin implementing its Prevention of 

Significant Deterioration and title V 

Greenhouse Gas Tailoring rule. EPA 

issued a final rule in May 2010 that 

establishes a common sense approach to 

addressing greenhouse gas emissions 

from stationary sources under the Clean 

Air Act (CAA) permitting programs. 

This final rule sets thresholds for 


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greenhouse gas (GHG) emissions that 

define when permits under the New 

Source Review Prevention of Significant 

Deterioration (PSD) and title V 

Operating Permit programs are required 

for new and existing industrial facilities. 

The rule ‘‘tailors’’ the requirements of 

these CAA permitting programs to limit 

which facilities will be required to 

obtain PSD and title V permits. 

2. Improving Air Quality 

Since passage of the Clean Air Act 

Amendments in 1990, nationwide air 

quality has improved significantly for 

the six criteria air pollutants for which 

there are national ambient air quality 

standards. Despite this progress, about 

127 million Americans lived in counties 

with air considered unhealthy in 2008. 

Long-term exposure to air pollution can 

cause cancer and damage to the 

immune, neurological, reproductive, 

cardiovascular, and respiratory systems. 

Review Air Quality Standards. 

Despite progress, millions of Americans 

still live in areas that exceed one or 

more of the national standards. Groundlevel ozone and particle pollution still 

present challenges in many areas of the 

country. This year’s regulatory plan 

describes efforts to review the primary 

National Ambient Air Quality Standards 

(NAAQS) for carbon monoxide, lead, 

and particulates. In addition, the Plan 

includes a joint review of the secondary 

NAAQS for oxides of nitrogen and 

oxides of sulfur. 

Replacing the Clean Air Interstate 

Rule. In the spring of 2011, EPA expects 

to complete and begin implementing a 

rule to replace the Transport Rule that 

was remanded by the courts in 2008. 

Strengthening the standards and 

decreasing the emissions that contribute 

to interstate transport of air pollution 

will help many areas of the country 

attain the standards and achieve 

significant improvements in public 

health. 

Cleaner Air from Improved 

Technology. EPA continues to address 

toxic air pollution under authority of 

the Clean Air Act Amendments of 1990. 

The centerpiece of this effort is the 

‘‘Maximum Achievable Control 

Technology’’ (MACT) program, which 

requires that all major sources of a given 

type use emission controls that better 

reflect the current state of the art. This 

year’s regulatory plan describes MACT 

standards under development for 

electric utility steam-generating units. 

3. Assuring the Safety of Chemicals 

One of EPA’s highest priorities is to 

make significant and long overdue 

progress in assuring the safety of 

chemicals. On September 29, 2009, 

Administrator Jackson announced clear 

principles to guide Congress in writing 

a new chemical risk management law 

that will fix the weaknesses in Toxic 

Substances Control Act (TSCA). EPA is 

shifting its focus to addressing highconcern chemicals and filling data gaps 

on widely produced chemicals in 

commerce. In 2011, EPA will 

aggressively assess and manage the risks 

of chemicals used in consumer 

products, and the workplace. 

Management of Chemical Risks.EPA’s 

Administrator has highlighted the need 

to strengthen EPA’s chemical 

management program as one of her top 

priorities. Using sound science as a 

compass, the mission of the Office of 

Chemical Safety and Pollution 

Prevention (OCSPP) is to protect 

individuals, families, and the 

environment from potential risks of 

pesticides and other chemicals. In its 

implementation of these programs, 

OCSPP uses several different statutory 

authorities, including the Federal 

Insecticide, Fungicide, and Rodenticide 

Act, the Federal Food, Drug, and 

Cosmetic Act, the Toxic Substances 

Control Act (TSCA) and the Pollution 

Prevention Act, as well as collaborative 

and voluntary activities. 

Enhancing EPA’s Current Chemicals 

Management Program under TSCA. As 

part of this comprehensive effort, EPA 

has developed plans on specific 

chemicals, which outline the concerns 

that each chemical may present and 

specific actions the Agency will take to 

address those concerns. The Agency 

considers a range of actions to address 

potential risks, including utilizing for 

the first time the TSCA section 5(b)(4) 

authority to list chemicals of concern. 

EPA also intends to propose several 

regulatory actions under TSCA to gather 

additional information on nanoscale 

chemical materials, which will help the 

Agency assess the safety of nanoscale 

chemicals. EPA is also taking a number 

of steps to provide the public with 

greater access to chemical information, 

which includes increased web access to 

TSCA data and new policies for the 

review of confidential business 

information (CBI) claims for substantial 

risk and health and safety studies. 

Addressing Concerns with Legacy 

Chemicals—Lead and Mercury. EPA is 

continuing its efforts to combat 

childhood lead poisoning through 

implementation of the Lead Renovation, 

Repair, and Painting (RRP) rule, which 

includes consideration of a proposed 

rule to require that renovation firms 

perform dust wipe testing after certain 

renovations and provide the results of 

the testing to the owners and occupants 

of the building. EPA also is developing 

a number of actions to further reduce 

the use of mercury in a range of 

products, including switches, relays, 

and certain measuring devices. 

Protecting Subjects in Human 

Research involving Pesticides. On June 

18, 2010, EPA settled a lawsuit over its 

2006 regulation that established 

protections for subjects of human 

research involving pesticides. Under the 

settlement agreement, EPA agreed that 

by January 18, 2011, it will propose to 

broaden the applicability of the 2006 

rule to apply to research involving 

intentional exposure of a human subject 

to ‘‘a pesticide,’’ without limitation as to 

the regulatory statutes under which the 

data might be submitted, considered, or 

relied upon. EPA also committed to 

propose amendments to the rule that 

would, if finalized, disallow consent by 

an authorized representative of a test 

subject and that would require the 

Agency, in its reviews of covered 

human research, to document its ethics 

and science considerations. 

Defining the Nature of Regulated 

Production of Plant-Incorporated 

Protectants (PIPs). PIPs are pesticidal 

substances intended to be produced and 

used in living plants and the genetic 

material needed for their production. 

EPA regulates PIPs under FIFRA and 

FFDCA, including issuing experimental 

use permits and commercial 

registrations. However, these Acts and 

the current implementing regulations do 

not specifically address what constitutes 

the production of PIPs or what units are 

relevant for purposes of reporting 

amounts of PIPs produced. This has led 

to inconsistency and confusion in the 

registration of PIP-producing 

establishments and in the reporting of 

units of PIPs produced, which in turn 

has resulted in significant difficulties in 

terms of compliance and enforcement. 

EPA intends to propose regulations to 

clarify the legal requirements applicable 

to PIP products at various phases of 

production. This rule will benefit the 

public by ensuring that public health 

and the environment are adequately 

protected while reducing burden on the 

regulated community, thereby 

potentially reducing costs for 

consumers. 

4. Cleaning Up Its Communities 

In 2009 EPA accelerated its 

Superfund program and confronted 

significant local environmental 

challenges like the asbestos Public 


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Health Emergency in Libby, Montana 

and the coal ash spill in Kingston, 

Tennessee. Using all the tools at its 

disposal, including enforcement and 

compliance efforts, EPA will continue to 

focus on making safer, healthier 

communities in 2011. EPA meets this 

priority by focusing on preparation for, 

prevention and response to chemical 

and oil spills, accidents, and 

emergencies; enhancement of homeland 

security; increasing the beneficial use 

and recycling of secondary materials, 

the safe management of wastes and 

cleaning up contaminated property and 

making it available for reuse. EPA 

carries out these missions in partnership 

with other Federal agencies, states, 

tribes, local governments, communities, 

nongovernmental organizations, and the 

private sector. Several regulatory 

priorities for the upcoming fiscal year 

will promote stewardship and resource 

conservation and focus regulatory 

efforts on risk reduction and statutory 

compliance. 

Financial Responsibility under 

Superfund. Section 108(b) of the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA), establishes certain 

authorities concerning financial 

responsibility requirements. The 

Agency has identified classes of 

facilities within the Hard Rock mining 

industry as those for which financial 

responsibility requirements will be first 

developed. This proposal will establish 

requirements for financial 

responsibility, notification, and 

implementation. 

Non-Hazardous Secondary Materials. 

The Agency has proposed to define 

which non-hazardous secondary 

materials burned in combustion units 

are solid wastes under the Resource 

Conservation and Recovery Act (RCRA). 

This in turn will assist the Agency in 

determining which non-hazardous 

secondary materials will be subject to 

the emissions standards proposed under 

either section 112 or section 129 of the 

Clean Air Act (CAA). If the nonhazardous secondary material is 

considered a ‘‘solid waste,’’ the unit that 

burns the non-hazardous secondary 

material would be subject to the CAA 

section 129 requirements, while if the 

non-hazardous secondary materials 

would not be considered a ‘‘solid 

waste,’’ it would be subject to the CAA 

section 112 requirements. 

Geologic Sequestration. In 2008, the 

Safe Drinking Water Act Underground 

Injection Control Program proposed to 

create a new class of injection wells 

(Class VI) for geological sequestration 

(GS) of carbon dioxide (CO2). EPA 

received numerous comments asking for 

clarification on how the Resource 

Conservation and Recovery Act (RCRA) 

hazardous waste requirements apply to 

CO2 streams. EPA is now considering a 

proposed rule under RCRA to explore a 

number of options. 

5. Protecting America’s Waters 

Despite considerable progress, 

America’s waters remain imperiled. 

Water quality and enforcement 

programs face complex challenges, from 

nutrient loadings and stormwater runoff 

to invasive species and drinking water 

contaminants. These challenges demand 

both traditional and innovative 

strategies. 

Improving Water Quality. EPA plans 

to address challenging water quality 

issues in several rulemakings during 

fiscal year 2011. 

Stormwater. First, EPA plans to 

propose a national rule to address 

stormwater discharges from new 

development and redevelopment and 

explore other regulatory improvements 

to its stormwater program. To address 

the degradation of water quality caused 

by stormwater discharges from 

impervious cover, EPA is exploring 

regulatory options, including 

establishing specific post construction 

requirements for stormwater discharges 

from, at a minimum, new development 

and redevelopment. Stormwater 

discharges from areas of impervious 

cover in developed areas are a 

significant contributor to water quality 

impairments in receiving waters. 

Sanitary Sewer Overflows. EPA is also 

considering proposing modifications to 

the NPDES regulations as they apply to 

municipal sanitary sewer collection 

systems and sanitary sewer overflows 

(SSOs) in order to better protect the 

environment and public health from the 

harmful effects of sanitary sewer 

overflows and basement back ups. Some 

of the changes EPA is considering 

include establishing standard permit 

conditions for publicly owned treatment 

works (POTW) permits that specifically 

address sanitary sewer collection 

systems and SSOs, and clarifying the 

regulatory framework for applying 

NPDES permit conditions to municipal 

satellite collection systems. Municipal 

satellite collection systems are sanitary 

sewers owned or operated by a 

municipality that conveys wastewater to 

a POTW operated by a different 

municipality. 

Use of Offsets. EPA plans to propose 

a National Pollutant Discharge 

Elimination System permit regulation 

for new dischargers and the appropriate 

use of offsets with regard to water 

quality permitting. This action may 

consider how to best clarify EPA’s 

approach to permitting new dischargers 

in order to ensure the protection of 

water quality under Clean Water Act 

and may examine options to address the 

appropriate and permissible use of 

offsets which ensures that NPDES 

permits are protective of water quality 

standards. Additionally, EPA may 

examine options for addressing new 

dischargers in impaired waters, both 

when a TMDL is in place and prior to 

TMDL issuance. 

Concentrated Animal Feeding 

Operations. In 2008, EPA amended the 

concentrated animal feeding operation 

(CAFO) regulation to require, among 

other things, CAFOs that discharge or 

propose to discharge to seek coverage 

under an NPDES permit. Under the 

authority of section 308 of the Clean 

Water Act, EPA is proposing a rule to 

collect facility information from all 

CAFOs which will provide a CAFO 

inventory and assist in implementing 

the 2008 CAFO rule. 

Cooling Water Intake Structures. EPA 

plans to propose standards for cooling 

water intakes for electric power plants 

and for other manufacturers who use 

large amounts of cooling water. The goal 

of the proposed rule will be to protect 

aquatic organisms from being killed or 

injured through impingement or 

entrainment. 

Improving Clean Water Act 

Enforcement. EPA has the primary 

responsibility to ensure that the Clean 

Water Act’s (CWA) National Pollutant 

Discharge Elimination System (NPDES) 

program is effectively and consistently 

implemented across the country, thus 

ensuring that public health and 

environmental protection goals of the 

CWA are met. EPA needs site-specific 

information to provide national NPDES 

program direction and oversight, to 

inform Congress and the public, and to 

better ensure protection of public health 

and the environment. EPA plans to 

propose an NPDES Electronic Reporting 

Rule that will seek to improve the EPA’s 

access to facility-specific information 

for the diverse universe of NPDESregulated sources of wastewater 

discharges. Electronic reporting of 

NPDES information may be sought from 

NPDES permittees and/or States. 

6. Expanding the Conversation on 

Environmentalism and Working for 

Environmental Justice. 

Environmentalism has been described 

as a conversation that we all must have 


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because it is about protecting people in 

the places they live, work, and raise 

families. In FY 2011, the Agency is 

focused on expanding the conversation 

to include new stakeholders and involve 

communities in more direct ways. 

In managing risk and in ensuring that 

environmental rules protect all 

Americans, EPA directs its efforts 

toward identifying and mitigating 

exposures and other factors in our 

communities, schools, homes, and 

workplaces that might negatively impact 

human health and environmental 

quality. A renewed focus is being placed 

on the continuing Environmental Justice 

(EJ) efforts to address the environmental 

and public health concerns of minority, 

low income, tribal, and other 

disproportionately burdened 

communities and focus on improving 

environmental and public health 

protection in these communities. 

Environmental Justice in Rulemaking. 

In July 2010, EPA released an interim 

guidance document to help Agency staff 

include environmental justice 

principles in its rulemaking process. 

The rulemaking guidance is an 

important and positive step toward 

meeting EPA Administrator Lisa P. 

Jackson’s priority to work for 

environmental justice and protect the 

health and safety of communities who 

have been disproportionately impacted 

by pollution. In carrying out this 

mandate, EPA will also seek to ensure 

that such communities do not 

experience disproportionate economic 

impacts from its programs and 

regulations. 

Children’s Health. The protection of 

vulnerable subpopulations is one of the 

EPA’s top priorities, especially with 

regard to children. EPA’s revitalized 

Children’s Health Office is bringing a 

new energy to safeguarding children 

through the entire Agency’s regulatory 

and enforcement efforts. In 2011, EPA 

will co-lead an interagency effort in 

integrating existing school programs 

including asthma, indoor air quality, 

chemical safety and management, green 

practices, and enhanced use of 

integrated pest management. 

7. Building Strong State and Tribal 

Partnerships 

EPA’s success depends more than 

ever on working with increasingly 

capable and environmentally conscious 

partners. The Agency works with the 

States and tribes, business and industry, 

nonprofit organizations, environmental 

groups, and educational institutions in 

a wide variety of collaborative efforts. 

Currently, more than 13,000 firms and 

other organizations participate in EPA 

partnership programs. States and tribal 

nations bear important responsibilities 

for the day-to-day mission of 

environmental protection, but declining 

tax revenues and fiscal challenges are 

pressuring State agencies and tribal 

governments to do more with fewer 

resources. EPA must do its part to 

support State and tribal capacity. 

Recognizing the Right of Tribes as 

Sovereign Nations. In FY 2009, EPA 

Administrator Jackson reaffirmed the 

Agency’s Indian Policy, which 

recognizes that the United States has a 

unique legal relationship with tribal 

governments based on treaties, statutes, 

executive orders, and court decisions. 

EPA recognizes the right of Tribes as 

sovereign governments to selfdetermination and acknowledges the 

federal government’s trust responsibility 

to Tribes. In FY 2011, EPA and Tribes 

are focusing on drinking water, 

sanitation, schools, and properly 

managing solid and hazardous waste on 

tribal lands. 

Conclusion 

These priorities will guide EPA’s 

work in the years ahead. They are built 

around the challenges and opportunities 

inherent in our mission to protect 

human health and the environment for 

all Americans. This mission is carried 

out by respecting EPA’s core values of 

science, transparency, and the rule of 

law. Within these parameters, EPA 

carefully considers the impacts its 

regulatory actions will have on society. 

Aggregate Costs and Benefits 

EPA has calculated a combined 

aggregate estimate of the costs and 

benefits of regulations included in the 

regulatory plan. For the fiscal year 2009, 

EPA has been able to gather sufficient 

data on 5 of the 30 anticipated 

regulations to include them in an 

aggregate estimate. For the remaining 

actions, costs and benefits have not yet 

been calculated for various reasons. 

The regulations included in the 

aggregate estimate of costs and benefits 

are: 

• Federal Transport Rule; 

• Combined Rulemaking for 

Industrial, Commercial, and 

Institutional Boilers and Process Heaters 

at Major Sources of HAP and Industrial, 

Commercial, and Institutional Boilers at 

Area Sources; 

• National Emission Standards for 

Hazardous Air Pollutants for Major 

Sources: Industrial, Commercial & 

Institutional Boilers and Process 

Heaters; 

• Lead; Clearance and Clearance 

Testing Requirements for the 

Renovation, Repair, and Painting 

Program; and 

• Criteria and Standards for Cooling 

Water Intake Structures—Phase II 

Remand. 

EPA obtained aggregate estimates of 

total costs and benefits assuming both a 

3 percent discount rate and a 7 percent 

discount rate. One of the five 

regulations (TSCA Lead Renovation) 

included costs estimates but provided 

no estimate of the monetized benefit of 

the rule. Given a 3 percent discount 

rate, benefits range from $144 billion to 

$349 billion. With a 7 percent discount 

rate, benefits range from $132 billion to 

$323 billion. Costs were relatively 

constant, approximately $6 billion, 

regardless of the discount rate. All 

values are 2008 dollars. For the two 

rules that did not use a 2008 base year, 

values were converted using a GDP 

deflator. 

These results should be considered 

with caution for a number of reasons. 

First, there are significant gaps in data. 

In general, the benefits estimates 

reported above do not include values for 

benefits that have been quantified but 

not monetized and missing values for 

qualitative benefits, such as some 

human health benefits and ecosystem 

health improvements. Second, 

methodologies and types of 

costs/benefits considered are 

inconsistent, as are the units of analysis. 

Some of the costs/benefits are described 

as annualized values while other values 

are specific to one year. Third, problems 

with aggregation can arise from differing 

baselines. Finally, the ranges presented 

do not reflect the full range of 

uncertainty in the benefit and cost 

estimates for these rules. 

Rules Expected to Affect Small Entities 

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. Actions that 

may affect small entities can be tracked 

on EPA’s Rulemaking Gateway 

(http://www.epa.gov/lawsregs/ 

rulemaking/index.html) at any time. 

This Plan includes a number of rules 

that may be of particular interest to 

small entities: 

• National Emission Standards for 

Hazardous Air Pollutants for Area 


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Sources: Industrial, Commercial, and 

Institutional Boilers (2060-AM44); 

• National Emission Standards for 

Hazardous Air Pollutants for Major 

Sources: Industrial, Commercial, and 

Institutional Boilers and Process 

Heaters (2060-AQ25); 

• Lead; Clearance and Clearance 

Testing Requirements for the 

Renovation, Repair, and Painting 

Program (2070-AJ57) 

• Stormwater Regulations Revision to 

Address Discharges from Developed 

Sites (2040-AF13). 

EPA 

PROPOSED RULE STAGE 

130. REVIEW OF THE NATIONAL 

AMBIENT AIR QUALITY STANDARDS 

FOR CARBON MONOXIDE 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

42 USC 7408; 42 USC 7409 

CFR Citation: 

40 CFR 50 

Legal Deadline: 

NPRM, Judicial, October 28, 2010, US 

District Court Northern District of CA 

San Francisco Division 5/5/08. 

Final, Judicial, May 13, 2011, US 

District Court Northern District of CA 

San Francisco Division 5/5/08. 

Abstract: 

Under the Clean Air Act, EPA is 

required to review and, if appropriate, 

revise the air quality criteria for the 

primary (health-based) and secondary 

(welfare-based) national ambient air 

quality standards (NAAQS) every 5 

years. The last CO NAAQS review 

occurred in 1994 with a decision by 

the Administrator not to revise the 

existing standards. The current review 

which initiated in September 2007 

includes the preparation of an 

Integrated Science Assessment, 

Risk/Exposure Assessment, and a 

Policy Assessment Document by EPA, 

with opportunities for review by EPA’s 

Clean Air Scientific Advisory 

Committee and the public. These 

documents inform the Administrator’s 

decision as to whether to retain or 

revise the standards. 

Statement of Need: 

As established in the Clean Air Act, 

the national ambient air quality 

standards for carbon monoxide are to 

be reviewed every 5 years. 

Summary of Legal Basis: 

Section 109 of the Clean Air Act (42 

U.S.C. 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. 

Alternatives: 

The main alternatives for the 

Administrator’s decision on the review 

of the national ambient air quality 

standards for CO are whether to retain 

or revise the existing standards. 

Anticipated Cost and Benefits: 

The Clean Air Act makes clear that the 

economic and technical feasibility of 

attaining standards are not to be 

considered in setting or revising the 

NAAQS, although such factors may be 

considered in the development of State 

plans to implement the standards. 

Accordingly, the Agency prepares cost 

and benefit information in order to 

provide States information that may be 

useful in considering different 

implementation strategies for meeting 

proposed or final standards. Cost and 

benefit information is not developed to 

support a NAAQS rulemaking until 

sufficient policy and scientific 

information is available to narrow 

potential options for the form and level 

associated with any potential revisions 

to the standard. Therefore, work on 

developing the plan for conducting the 

cost and benefit analysis will generally 

start 1 1/2 to 2 years following the start 

of a NAAQS review. 

Risks: 

During the course of this review, risk 

assessments will be conducted to 

evaluate health risks associated with 

retention or revision of the CO 

standards. 

Timetable: 

Action Date FR Cite 

NPRM 02/00/11 

Final Action 08/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal, State, Local, Tribal 

Additional Information: 

EPA Docket information: EPA-HQ-OAR2008-0015 

URL For More Information: 

http://www.epa.gov/ttn/naaqs/ 

standards/co/slcolindex.html 

Agency Contact: 

Ines Pagan 

Environmental Protection Agency 

Air and Radiation 

C504–06 

Research Triangle Park, NC 27711 

Phone: 919 541–5469 

Email: pagan.ines@epa.gov 

Deirdre Murphy 

Environmental Protection Agency 

Air and Radiation 

C504–06 

Research Triangle Park, NC 27711 

Phone: 919 541–0729 

Email: murphy.deirdre@epa.gov 

RIN: 2060–AI43 

EPA 

131. REVIEW OF THE NATIONAL 

AMBIENT AIR QUALITY STANDARDS 

FOR PARTICULATE MATTER 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

42 USC 7408; 42 USC 7409 

CFR Citation: 

40 CFR 50 

Legal Deadline: 

None 

Abstract: 

Under the Clean Air Act, EPA is 

required to review and, if appropriate, 

revise the air quality criteria for the 

primary (health-based) and secondary 

(welfare-based) national ambient air 

quality standards (NAAQS) every 5 

years. On October 17, 2006, EPA 

published a final rule to revise the 

primary and secondary NAAQS for 

particulate matter to provide increased 

protection of public health and welfare. 

With regard to the primary standard for 

fine particles (generally referring to 

particles less than or equal to 2.5 

micrometers in diameter, PM2.5), EPA 


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revised the level of the 24-hour PM2.5 

standard to 35 micrograms per cubic 

meter (ug/m3) and retained the level 

of the annual PM2.5 standard at 15 

ug/m3. With regard to primary 

standards for particles generally less 

than or equal to 10 micrometers in 

diameter (PM10), EPA retained the 24- 

hour PM10 standard and revoked the 

annual PM10 standard. With regard to 

secondary PM standards, EPA made 

them identical in all respects to the 

primary PM standards, as revised. EPA 

initiated the current review in 2007 

with a workshop to discuss key policyrelevant issues around which EPA 

would structure the review. This 

review includes the preparation of an 

Integrated Science Assessment (ISA), 

Risk/Exposure Assessment (REA), and 

a Policy Assessment (PA) by EPA, with 

opportunities for review by EPA’s 

Clean Air Scientific Advisory 

Committee and the public. These 

documents inform the Administrator’s 

decision as to whether to retain or 

revise the standards. The ISA was 

completed in December 2009, the final 

REAs for health risk assessment and 

visibility assessment were finalized in 

June and July 2010, respectively. The 

first draft PA was reviewed by CASAC 

on April 8-9, 2010. The second draft 

Policy Assessment was reviewed by 

CASAC on July 26-27, 2010. 

Statement of Need: 

As established in the Clean Air Act, 

the national ambient air quality 

standards for particulate matter are to 

be reviewed every 5 years. 

Summary of Legal Basis: 

Section 109 of the Clean Air Act (42 

U.S.C. 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. 

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 retain or revise the existing 

standards and, if revisions are 

necessary, the indicators, averaging 

times, forms and levels of the revised 

standards. Options for these 

alternatives will be developed as the 

rulemaking proceeds. 

Anticipated Cost and Benefits: 

The Clean Air Act makes clear that the 

economic and technical feasibility of 

attaining standards are not to be 

considered in setting or revising the 

NAAQS, although such factors may be 

considered in the development of State 

plans to implement the standards. 

Accordingly, the Agency prepares cost 

and benefit information in order to 

provide States information that may be 

useful in considering different 

implementation strategies for meeting 

proposed or final standards. Cost and 

benefit information is not developed to 

support a NAAQS rulemaking until 

sufficient policy and scientific 

information is available to narrow 

potential options for the form and level 

associated with any potential revisions 

to the standard. Therefore, work on 

developing the plan for conducting the 

cost and benefit analysis will generally 

start 1 1/2 to 2 years following the start 

of a NAAQS review. 

Risks: 

During the course of this review, risk 

assessments have been conducted to 

evaluate health risks associated with 

retention or revision of the particulate 

matter standards. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Final Action 11/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal, Local, State, Tribal 

Additional Information: 

EPA Docket information: EPA-HQ-OAR2007-0492 

URL For More Information: 

www.epa.gov/air/particlepollution/ 

Agency Contact: 

Beth Hassett–Sipple 

Environmental Protection Agency 

Air and Radiation 

C504–06 

Research Triangle Park, NC 27711 

Phone: 919 541–4605 

Fax: 919 541–0237 

Email: hassett-sipple.beth@epa.gov 

Karen Martin 

Environmental Protection Agency 

Air and Radiation 

C504–06 

Research Triangle Park, NC 27711 

Phone: 919 541–5274 

Fax: 919 541–0237 

Email: martin.karen@epamail.epa.gov 

RIN: 2060–AO47 

EPA 

132. REVIEW OF THE SECONDARY 

NATIONAL AMBIENT AIR QUALITY 

STANDARDS FOR OXIDES OF 

NITROGEN AND OXIDES OF SULFUR 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

42 USC 7408; 42 USC 7409 

CFR Citation: 

40 CFR 50 

Legal Deadline: 

NPRM, Judicial, July 12, 2011. 

Final, Judicial, March 20, 2012, The 

court has approved the amendments to 

the consent decree incorporating the 

revised dates. 

Abstract: 

Under the Clean Air Act, EPA is 

required to review and, if appropriate, 

revise the air quality criteria for the 

primary (health-based) and secondary 

(welfare-based) national ambient air 

quality standards (NAAQS) every 5 

years. On October 11, 1995, EPA 

published a final rule not to revise 

either the primary or secondary 

NAAQS for nitrogen dioxide (NO2). On 

May 22, 1996, EPA published a final 

decision that revisions of the primary 

and secondary NAAQS for sulfur 

dioxide (SO2) were not appropriate at 

that time, aside from several minor 

technical changes. On December 9, 

2005, EPA’s Office of Research and 

Development (ORD) initiated the 

current periodic review of NO2 air 

quality criteria with a call for 

information in the Federal Register 

(FR). On May 3, 2006, ORD initiated 


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the current periodic review of SO2 air 

quality criteria with a call for 

information in the FR. Subsequently, 

the decision was made to review the 

oxides of nitrogen and the oxides of 

sulfur together, rather than 

individually, with respect to a 

secondary welfare standard for NO2 

and SO2. This decision derives from 

the fact that NO2, SO2, and their 

associated transformation products are 

linked from an atmospheric chemistry 

perspective, as well as from an 

environmental effects perspective, most 

notably in the case of secondary aerosol 

formation and acidification in 

ecosystems. This review includes the 

preparation of an Integrated Science 

Assessment (ISA), Risk/Exposure 

Assessment (REA), and a Policy 

Assessment Document (PAD) by EPA, 

with opportunities for review by EPA’s 

Clean Air Scientific Advisory 

Committee and the public. These 

documents inform the Administrator’s 

proposed decision as to whether to 

retain or revise the standards. It should 

be noted that this review will be 

limited to only the secondary 

standards; the primary standards for 

SO2 and NO2 were reviewed 

separately. The ISA, REA and first draft 

PAD have been completed and a review 

of the second draft PAD by CASAC is 

anticipated on October 6 and 7, 2010. 

Statement of Need: 

As established in the Clean Air Act, 

the national ambient air quality 

standards for oxides of nitrogen and 

oxides of sulfur are to be reviewed 

every 5 years. 

Summary of Legal Basis: 

Section 109 of the Clean Air Act (42 

U.S.C. 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. 

Alternatives: 

The main alternatives for the 

Administrator’s decision on the review 

of the national ambient air quality 

standards for oxides of nitrogen and 

oxides of sulfur are whether to retain 

or revise the existing standards. 

Anticipated Cost and Benefits: 

The Clean Air Act makes clear that the 

economic and technical feasibility of 

attaining standards are not to be 

considered in setting or revising the 

NAAQS, although such factors may be 

considered in the development of State 

plans to implement the standards. 

Accordingly, the Agency prepares cost 

and benefit information in order to 

provide States information that may be 

useful in considering different 

implementation strategies for meeting 

proposed or final standards. Cost and 

benefit information is not developed to 

support a NAAQS rulemaking until 

sufficient policy and scientific 

information is available to narrow 

potential options for the form and level 

associated with any potential revisions 

to the standard. Therefore, work on the 

developing the plan for conducting the 

cost and benefit analysis will generally 

start 1 1/2 to 2 years following the start 

of a NAAQS review. 

Risks: 

During the course of this review, risk 

assessments may be conducted to 

evaluate public welfare risks associated 

with retention or revision of the 

NOx/SOx secondary standards. 

Timetable: 

Action Date FR Cite 

NPRM 07/00/11 

Final Action 03/00/12 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal, Local, State, Tribal 

Additional Information: 

EPA Docket information: EPA-HQ-OAR2007-1145 

Agency Contact: 

Bryan Hubbell 

Environmental Protection Agency 

Air and Radiation 

C504–02 

Research Triangle Park, NC 27711 

Phone: 919 541–0621 

Fax: 919 541–0804 

Email: hubbell.bryan@epa.gov 

Ginger Tennant 

Environmental Protection Agency 

Air and Radiation 

C504–06 

Research Triangle Park, NC 27711 

Phone: 919 541–4072 

Fax: 919 541–0237 

Email: tennant.ginger@epa.gov 

RIN: 2060–AO72 

EPA 

133. NATIONAL EMISSION 

STANDARDS FOR HAZARDOUS AIR 

POLLUTANTS FOR COAL– AND 

OIL–FIRED ELECTRIC UTILITY STEAM 

GENERATING UNITS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

Clean Air Act sec 112(d) 

CFR Citation: 

40 CFR 63 

Legal Deadline: 

NPRM, Judicial, March 16, 2011, No 

later than March 16, 2011, EPA shall 

sign for publication in the Federal 

Register a notice of proposed 

rulemaking. 

Final, Judicial, November 16, 2011, No 

later than November 16, 2011, EPA 

shall sign for publication in the Federal 

Register a notice of final rulemaking. 

Abstract: 

On May 18, 2005 (70 FR 28606), EPA 

published a final rule requiring 

reductions in emissions of mercury 

from Electric Utility Steam Generating 

Units. That rule was vacated on 

February 8, 2008, by the U.S. Court of 

Appeals for the District of Columbia 

Circuit. As a result of that vacatur, coaland oil-fired electric utility steam 

generating units remain on the list of 

sources that must be regulated under 

section 112 of the Clean Air Act (CAA). 

The Agency will develop standards 

under CAA section 112(d), which will 

reduce hazardous air pollutant (HAP) 

emissions from this source category. 

Recent court decisions on other CAA 

section 112(d) rules will be considered 

in developing this regulation. 

Statement of Need: 

Section 112(n)(1)(A) of the Clean Air 

Act required EPA to conduct a study 

of the hazards to public health resulting 

from emissions of hazardous air 

pollutants from electric utility steam 

generating units and, after considering 

the results of that study, determine 

whether it was appropriate and 

necessary to regulate such units under 

section 112. The study was completed 

in 1998 and in December 2000, EPA 

determined that it was appropriate and 

necessary to regulate coal- and oil-fired 

electric utility steam generating units 


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and added such units to the list of 

sources for which standards must be 

developed under section 112. The 

February 8, 2008, vacatur of the May 

18, 2005, Clean Air Mercury Rule and 

March 29, 2005, section 112(n) 

Revision Rule (which had removed 

such sources from the list) resulted in 

the requirement to regulate under 

section 112 being reinstated. 

Summary of Legal Basis: 

Clean Air Act, section 112 

Alternatives: 

Not yet determined. 

Anticipated Cost and Benefits: 

Not yet determined. 

Risks: 

Not yet determined. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Final Action 11/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Federal, Local, State, Tribal 

Federalism: 

Undetermined 

Additional Information: 

EPA Docket information: EPA-HQ-OAR2009-0234 

Sectors Affected: 

221112 Fossil Fuel Electric Power 

Generation 

Agency Contact: 

Bill Maxwell 

Environmental Protection Agency 

Air and Radiation 

D243–01 

Research Triangle Park, NC 27711 

Phone: 919 541–5430 

Fax: 919 541–5450 

Email: maxwell.bill@epamail.epa.gov 

Robert J Wayland 

Environmental Protection Agency 

Air and Radiation 

C439–01 

Research Triangle Park, NC 27711 

Phone: 919 541–1045 

Email: wayland.robertj@epamail.epa.gov 

RIN: 2060–AP52 

EPA 

134. CONTROL OF GREENHOUSE 

GAS EMISSIONS FROM MEDIUM AND 

HEAVY–DUTY VEHICLES 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

Clean Air Act sec 202 

CFR Citation: 

40 CFR 1036, 1037, 1066, and 1068 

Legal Deadline: 

None 

Abstract: 

This action will be jointly proposed by 

the Environmental Protection Agency 

(EPA) and the Department of 

Transportation (DOT) to set national 

emission standards under the Clean Air 

Act (CAA) and Energy Independence 

and Security Act (EISA) to reduce 

greenhouse gas emissions and improve 

fuel energy for heavy duty trucks and 

buses. This rulemaking would 

significantly reduce GHG emissions 

from future heavy duty vehicles by 

setting GHG standards that would lead 

to the introduction of GHG-reducing 

vehicle and engine technologies. This 

action follows the U.S. Supreme Court 

decision in Massachusetts vs. EPA and 

would follow EPA’s formal 

determination on endangerment for 

GHG emissions. This rulemaking also 

follows the Advance Notice of 

Proposed Rulemaking ‘‘Regulating 

Greenhouse Gas Emissions Under the 

Clean Air Act,’’ (73 FR 44354, Jul. 20, 

2008). 

Statement of Need: 

EPA recently proposed to find that 

emissions of greenhouse gases from 

new motor vehicles and engines cause 

or contribute to air pollution that may 

reasonably be anticipated to endanger 

public health and welfare. Therefore, 

there is a need to reduce GHG 

emissions from medium- and heavyduty vehicles to protect public health 

and welfare. The medium- and heavyduty truck sector accounts for 

approximately 18 percent of the U.S. 

mobile source GHG emissions and is 

the second largest mobile source sector. 

GHG emissions from this sector are 

forecast to continue increasing rapidly; 

reflecting the anticipated impact of 

factors such as economic growth and 

increased movement of freight by 

trucks. This rulemaking would 

significantly reduce GHG emissions 

from future medium- and heavy-duty 

vehicles by setting GHG standards that 

will lead to the introduction of GHG 

reducing vehicle and engine 

technologies. 

Summary of Legal Basis: 

The Clean Air Act section 202(a)(1) 

states that ‘‘The Administrator shall by 

regulation prescribe (and from time to 

time revise) in accordance with the 

provisions of this section, standards 

applicable to the emission of any air 

pollutant from any class or classes of 

new motor vehicles or new motor 

vehicle engines, which in his judgment 

cause, or contribute to, air pollution 

which may reasonably be anticipated to 

endanger public health or welfare.’’ 

Section 202(a) covers all on-highway 

vehicles including medium- and heavyduty trucks. In April 2007, the Supreme 

Court found in Massachusetts v. EPA 

that greenhouse gases fit well within 

the Act’s capacious definition of ‘‘air 

pollutant’’ and that EPA has statutory 

authority to regulate emission of such 

gases from new motor vehicles. Lastly, 

in April 2009, EPA issued the Proposed 

Endangerment and Cause or Contribute 

Findings for Greenhouse Gases under 

the Clean Air Act. The endangerment 

proposal stated that greenhouse gases 

from new motor vehicles and engines 

cause or contribute to air pollution that 

may reasonably be anticipated to 

endanger public health and welfare. 

Alternatives: 

The rulemaking proposal will include 

an evaluation of regulatory alternatives 

that can be considered in addition to 

the Agency’s primary proposal. In 

addition, the proposal is expected to 

include tools such as averaging, 

banking, and trading of emissions 

credits as an alternative approach for 

compliance with the proposed program. 

Anticipated Cost and Benefits: 

Detailed analysis of economy-wide cost 

impacts, greenhouse gas emission 

reductions, and societal benefits will be 

performed during the rulemaking 

process. Initial estimates indicate that 

the vehicles produced during the first 

5 years after implementation of the 

program could achieve reductions of up 

to 250 million metric ton of CO2 

emissions during the lifetime of these 

trucks. The costs associated with the 

GHG control technologies are expected 

to pay for themselves through fuel cost 

savings within the first 2 to 5 years 

of the vehicle’s life. 


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Risks: 

The failure to set new GHG standards 

for medium- and heavy-duty trucks 

risks continued increases in GHG 

emissions from the trucking industry 

and therefore increased risk of 

unacceptable climate change impacts. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Final Action 08/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Undetermined 

Additional Information: 

SAN No. 5355. 

Agency Contact: 

Byron Bunker 

Environmental Protection Agency 

Air and Radiation 

AAHDOC 

Ann Arbor, MI 48105 

Phone: 734 214–4155 

Email: bunker.byron@epamail.epa.gov 

Angela Cullen 

Environmental Protection Agency 

Air and Radiation 

AAHDOC 

Ann Arbor, MI 48105 

Phone: 734 214–4419 

Email: cullen.angela@epamail.epa.gov 

RIN: 2060–AP61 

EPA 

135. ∑ REVIEW OF THE NATIONAL 

AMBIENT AIR QUALITY STANDARDS 

FOR LEAD 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

42 USC 7408; 42 USC 7409 

CFR Citation: 

40 CFR 50 

Legal Deadline: 

None 

Abstract: 

Under the Clean Air Act Amendments 

of 1977, EPA is required to review and 

if appropriate revise the air quality 

criteria for the primary (health-based) 

and secondary (welfare-based) national 

ambient air quality standards (NAAQS) 

every 5 years. On November 12, 2008, 

EPA published a final rule to revise the 

primary and secondary NAAQS for lead 

to provide increased protection for 

public health and welfare. With regard 

to the primary standard, EPA revised 

the level to 0.15 micrograms per cubic 

meter (ug/m3) of lead in total 

suspended particles and the averaging 

time to a rolling 3-month period with 

a maximum (not-to-be-exceeded) form, 

evaluated over a 3-year period. EPA 

revised the secondary standard to be 

identical in all respects to the revised 

primary standard. EPA has now 

initiated the next review. The review 

began in May 2010 with a workshop 

to discuss key policy-relevant issues 

around which EPA would structure the 

review. This review includes the 

preparation of an Integrated Science 

Assessment, and if warranted, a 

Risk/Exposure Assessment and also a 

Policy Assessment Document by EPA, 

with opportunities for review by EPA’s 

Clean Air Scientific Advisory 

Committee and the public. These 

documents inform the Administrator’s 

proposed decision as to whether to 

retain or revise the standards. 

Statement of Need: 

As established in the Clean Air Act, 

the national ambient air quality 

standards for lead are to be reviewed 

every 5 years. 

Summary of Legal Basis: 

Section 109 of the Clean Air Act (42 

U.S.C. 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. 

Alternatives: 

The main alternatives for the 

Administrator’s decision on the review 

of the national ambient air quality 

standards for lead are whether to retain 

or revise the existing standards. 

Anticipated Cost and Benefits: 

The Clean Air Act makes clear that the 

economic and technical feasibility of 

attaining standards are not to be 

considered in setting or revising the 

NAAQS, although such factors may be 

considered in the development of State 

plans to implement the standards. 

Accordingly, the Agency prepares cost 

and benefit information in order to 

provide States information that may be 

useful in considering different 

implementation strategies for meeting 

proposed or final standards. Cost and 

benefit information is not developed to 

support a NAAQS rulemaking until 

sufficient policy and scientific 

information is available to narrow 

potential options for the form and level 

associated with any potential revisions 

to the standard. Therefore, work on 

developing the plan for conducting the 

cost and benefit analysis will generally 

start 1 1/2 to 2 years following the start 

of a NAAQS review. 

Risks: 

During the course of this review, risk 

assessments may, as warranted, be 

conducted to evaluate health and/or 

environmental risks associated with 

retention or revision of the lead 

standards. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/13 

Final Action 10/00/14 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal, Local, State, Tribal 

Additional Information: 

EPA Docket information: EPA-HQ-OAR2010-0108 

URL For More Information: 

http://www.epa.gov/ttn/naaqs/ 

standards/pb/slpblindex.html 

Agency Contact: 

Deirdre Murphy 

Environmental Protection Agency 

Air and Radiation 

C504–06 

Research Triangle Park, NC 27711 

Phone: 919 541–0729 

Email: murphy.deirdre@epa.gov 

Karen Martin 

Environmental Protection Agency 

Air and Radiation 

C504–06 

Research Triangle Park, NC 27711 

Phone: 919 541–5274 

Fax: 919 541–0237 

Email: martin.karen@epamail.epa.gov 

RIN: 2060–AQ44 


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EPA 

136. NPDES ELECTRONIC 

REPORTING RULE 

Priority: 

Other Significant 

Legal Authority: 

CWA secs 304(i) and 501(a), 33 USC 

1314(i) and 1361(a) 

CFR Citation: 

40 CFR 123, 403, and 501 

Legal Deadline: 

None 

Abstract: 

The U.S. Environmental Protection 

Agency (EPA) has responsibility to 

ensure that the Clean Water Act’s 

(CWA) National Pollutant Discharge 

Elimination System (NPDES) program 

is effectively and consistently 

implemented across the country. This 

regulation would identify the essential 

information that EPA needs to receive 

electronically, primarily from NPDES 

permittees with some data required 

from NPDES agencies (NPDESauthorized States, territories, and tribes) 

to manage the national NPDES 

permitting and enforcement program. 

Through this regulation, EPA seeks to 

ensure that such facility-specific 

information would be readily available, 

accurate, timely, and nationally 

consistent on the facilities that are 

regulated by the NPDES program. 

In the past, EPA primarily obtained this 

information from the Permit 

Compliance System (PCS). However, 

the evolution of the NPDES program 

since the inception of PCS has created 

an increasing need to better reflect a 

more complete picture of the NPDES 

program and the diverse universe of 

regulated sources. In addition, 

information technology has advanced 

significantly so that PCS no longer 

meets EPA’s national needs to manage 

the full scope of the NPDES program 

or the needs of individual States that 

use PCS to implement and enforce the 

NPDES program. 

Statement of Need: 

As the NPDES program and information 

technology have evolved in the past 

several decades, the Permit Compliance 

System (PCS), EPA’s NPDES national 

data system, which has been in use 

since 1985, has become increasingly 

ineffective in meeting the full scope of 

EPA’s and individual State’s needs to 

manage, direct, oversee, and report on 

the implementation and enforcement of 

the NPDES program. Therefore, a 

NPDES component of EPA’s existing 

Integrated Compliance Information 

System (ICIS), ICIS-NPDES, was 

designed and constructed based upon 

EPA and State input to manage data 

for the full breadth of the NPDES 

program. This rulemaking would 

identify essential NPDES-specific 

information EPA needs to receive from 

NPDES agencies (authorized States and 

tribes, as well as EPA Regions). This 

information will be managed by EPA 

in a format compatible with the new 

NPDES component of the Integrated 

Compliance Information System (ICIS) 

in order to better enable EPA to ensure 

the protection of public health and the 

environment, effectively manage the 

national NPDES permitting and 

enforcement program, identify and 

address environmental problems, and 

ultimately replace PCS. This action 

would be of interest primarily to 

NPDES permittees, NPDES-authorized 

states, and to the public at large, which 

would ultimately have increased access 

to this NPDES information. 

Summary of Legal Basis: 

In 1972, Congress passed the Clean 

Water Act to ‘‘restore and maintain the 

chemical, physical, and biological 

integrity of the Nation’s waters.’’ 33 

U.S.C. 1251(a). The Clean Water Act 

established a comprehensive program 

for protecting and restoring our 

Nation’s waters. The Clean Water Act 

prohibits the discharge of pollutants 

from a point source to waters of the 

United States except when authorized 

by a National Pollutant Discharge 

Elimination System (NPDES) permit. 

The Clean Water Act established the 

NPDES permit program to authorize 

and regulate the discharges of 

pollutants to waters of the United 

States. EPA has issued comprehensive 

regulations that implement the NPDES 

program at 40 CFR parts 122 to 125, 

129 to 133, 136, and subpart N. 

Under the NPDES permit program, 

point sources subject to regulation may 

discharge pollutants to waters of the 

United States subject to the terms and 

conditions of an NPDES permit. With 

very few exceptions (40 CFR 122.3), 

point sources require NPDES permit 

authorization to discharge, including 

both municipal and industrial 

discharges. NPDES permit authorization 

may be provided under an individual 

NPDES permit, which is developed 

after a process initiated by a permit 

application (40 CFR 122.21), or under 

a general NPDES permit, which, among 

other things, applies to one or more 

categories of dischargers (e.g., oil and 

gas facilities, seafood processors) with 

the same or substantially similar types 

of operations and the same effluent 

limitations, operating conditions, or 

standards for sewage sludge use or 

disposal [40 CFR 122.28(a)(2)]. 

The U.S. Environmental Protection 

Agency has the primary responsibility 

to ensure that the NPDES program is 

effectively and consistently 

implemented across the country, thus 

ensuring that public health and 

environmental protection goals of the 

CWA are met. Many States and some 

territories have received authorization 

to implement and enforce the NPDES 

program, and EPA works with its State 

partners to ensure effective program 

implementation and enforcement. CWA 

section 304(i)(2) directs EPA to 

promulgate guidelines establishing the 

minimum procedural and other 

elements of a State, territory, or tribal 

NPDES program, including monitoring 

requirements, reporting requirements 

(including procedures to make 

information available to the public), 

enforcement provisions, and funding, 

personnel qualifications, and 

manpower requirements [CWA section 

304(i)(2)]. 

EPA published NPDES State, territory, 

and tribal program regulations under 

CWA section 304(i)(2) at 40 CFR part 

123. Among other things, the part 123 

regulations specify NPDES program 

requirements for permitting, 

compliance evaluation programs, 

enforcement authority, sharing of 

information, transmission of 

information to EPA, and 

noncompliance and program reporting 

to EPA. 

This proposed rulemaking may add 

some specificity to those particular 

regulations regarding what NPDES 

information is required to be submitted 

to EPA by States and may modify other 

regulations to require electronic 

reporting of NPDES information by 

NPDES permittees to the States and 

EPA. 

Alternatives: 

For this proposed rulemaking, EPA has 

determined that the need for EPA’s 

receipt of such NPDES information 

exists. If, for whatever reason, 

electronic reporting by permittees is not 

a feasible option for certain NPDES 

information, the obvious alternative 

would be for EPA to require States to 

provide that information to EPA. The 

States already receive that information 

from the permittees, and therefore, they 

have the information that EPA seeks. 


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Within the rulemaking process itself, 

various alternatives are under 

consideration based on the feasibility 

of particular electronic reporting 

options. For example, EPA may 

consider establishing requirements for 

electronic reporting of discharge 

monitoring reports by NPDES 

permittees. Under this proposed 

rulemaking, EPA may consider 

establishing similar requirements for 

any or all of the following types of 

NPDES information: Notices of intent 

to discharge (for facilities seeking 

coverage under general permits), 

permitting information (including 

permit applications), various program 

reports (e.g., pretreatment compliance 

reports from approved local 

pretreatment programs, annual reports 

from concentrated animal feeding 

operations, biosolids reports, sewage 

overflow incident reports, annual 

reports for pesticide applicators, annual 

reports for municipal storm water 

systems), and annual compliance 

certifications. 

Some States might also raise the 

possibility of supplying only summarylevel information to EPA rather than 

facility-specific information to EPA. 

Based upon considerable experience, 

EPA considers such alternative nonfacility-specific data to be insufficient 

to meet its needs, except in very 

particular situations or reports. 

One alternative that EPA may consider 

for rule implementation is whether 

third-party vendors may be better 

equipped to develop and modify such 

electronic reporting tools than EPA. 

Anticipated Cost and Benefits: 

The economic analysis for this 

proposed rulemaking has not yet been 

completed; therefore, the dollar values 

of estimated costs and benefits are not 

yet known. However, some 

generalizations can still be made 

regarding expectations. EPA anticipates 

that electronic reporting of discharge 

monitoring reports (DMRs) by NPDES 

permittees will provide significant data 

entry cost savings for States and EPA. 

These discharge monitoring reports are 

already required to be submitted by 

NPDES permittees to States and EPA, 

which in turn currently enter that 

information into the State NPDES data 

system or EPA’s national NPDES data 

system. These discharge monitoring 

reports contain significant amounts of 

information regarding pollutants 

discharged, identified concentrations 

and quantities of pollutants, discharge 

locations, etc. Through electronic 

reporting by permittees, States, and 

EPA will no longer have associated 

data entry costs to enter this 

information. Electronic reporting by 

NPDES permittees of other NPDES 

information (such as notices of intent 

to discharge or various program reports) 

may also yield considerable data entry 

savings to the States and EPA. 

In addition, some States have been able 

to quantify savings by the permittees 

to electronically report their NPDES 

information using existing electronic 

reporting tools. Such savings are being 

examined in the economic analysis 

process for this rulemaking. 

Additional benefits of this rule will 

likely include improved transparency 

of information regarding the NPDES 

program, improved information 

regarding the national NPDES program, 

improved targeting of resources and 

enforcement based on identified 

program needs and noncompliance 

problems, and ultimately improved 

protection of public health and the 

environment. 

Some NPDES information will need to 

be reported by States to EPA; therefore, 

there will be some data entry costs 

associated with that information, but it 

will likely be far less than the savings 

that will be realized by States through 

electronic reporting by NPDES 

permittees. In addition, EPA will likely 

have sizable costs to develop tools for 

electronic reporting by permittees, as 

well as operation and maintenance 

costs associated with those tools. 

Risks: 

Given the scope of this proposed 

rulemaking, the most significant risks 

associated with this effort may be those 

if EPA does not proceed with this 

rulemaking. At this point, EPA does not 

receive sufficient NPDES information 

from the States to be able to fully assess 

the implementation of the national 

NPDES program nor the smaller 

subprograms. Such information is not 

currently required by EPA from the 

States, and the lack of such reporting 

requirements perpetuates this problem. 

Furthermore, EPA does not have 

facility-specific information regarding 

most of the facilities regulated under 

the NPDES program, and therefore, EPA 

cannot easily identify potential 

implementation problems or 

noncompliance problems. This lack of 

information may adversely impact 

EPA’s ability to better ensure the 

protection of public health and the 

environment, nationally and locally. 

A potential risk associated with this 

rule may involve EPA efforts to develop 

electronic reporting tools for use by 

permittees. The costs associated with 

the internal development of such tools, 

possibly for multiple types of NPDES 

information from various types of 

NPDES permittees, and the future costs 

of operation and maintenance may be 

substantial for EPA, possibly impacting 

the availability of funding for other 

purposes. Furthermore, EPA would also 

need to determine the feasibility of 

ensuring that the electronic tools can 

be flexible enough to meet State needs 

and work well with State data systems. 

Problems in the development and 

maintenance of these electronic tools 

could pose significant risks for the 

effective implementation of this rule. 

Timetable: 

Action Date FR Cite 

Notice—Public 

Meeting 

07/01/10 75 FR 38068 

NPRM 04/00/11 

Final Action 04/00/12 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

State 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Additional Information: 

SAN No. 5251 

Agency Contact: 

Andrew Hudock 

Environmental Protection Agency 

Office of Enforcement and Compliance 

Assurance 

2222A 

Washington, DC 20460 

Phone: 202 564–6032 

Email: hudock.andrew@epamail.epa.gov 

John Dombrowski 

Environmental Protection Agency 

Office of Enforcement and Compliance 

Assurance 

2222A 

Washington, DC 20460 

Phone: 202 566–0742 

Email: dombrowski.john@epamail.epa.gov 

RIN: 2020–AA47 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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EPA 

137. REGULATIONS TO FACILITATE 

COMPLIANCE WITH THE FEDERAL 

INSECTICIDE, FUNGICIDE, AND 

RODENTICIDE ACT BY PRODUCERS 

OF PLANT–INCORPORATED 

PROTECTANTS (PIPS) 

Priority: 

Other Significant 

Legal Authority: 

7 USC 136a et seq 

CFR Citation: 

40 CFR 174; 40 CFR 152; 40 CFR 156; 

40 CFR 167; 40 CFR 168; 40 CFR 169; 

40 CFR 172 

Legal Deadline: 

None 

Abstract: 

Plant-Incorporated Protectants (PIPs) 

are pesticidal substances intended to be 

produced and used in living plants and 

the genetic material needed for their 

production. EPA regulates PIPs under 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) and the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), including issuing 

experimental use permits and 

commercial registrations. In 2001, EPA 

published rules establishing much of 

the current regulatory structure for 

PIPs. This rulemaking effort is intended 

to address the issues that were not 

addressed in 2001, including defining 

the nature of regulated production of 

PIPs and associated issues such as 

reporting, product labeling and record 

keeping. The rule will affect those 

persons who produce PIPs and is 

expected to clarify the legal 

requirements of their products at 

various production phases, improving 

their ability to conduct business. It is 

expected to also improve the ability of 

the EPA to identify and respond to 

instances where there are potentially 

significant violations. EPA also intends 

to address activities that the Agency 

does not believe warrant regulation and 

will consider exempting those 

activities, as appropriate, from FIFRA 

in whole or in part. 

Statement of Need: 

This action is needed to clarify PIP 

regulations for the Agency and PIP 

developers, producers and farmers. 

Section 7 of FIFRA requires producers 

of pesticides to register their 

establishments with EPA and to submit 

annual reports stating the amounts of 

pesticides produced at each 

establishment. However, neither the 

Act nor the regulations promulgated 

under section 7 specifically address 

what constitutes the production of PIPs, 

or what units are relevant for purposes 

of reporting amounts of PIPs produced. 

This has led to inconsistency and 

confusion in the registration of PIPproducing establishments and in the 

reporting of units of PIPs produced. 

Members of the PIP production 

industry have indicated that they are 

uncertain of their legal obligations for 

PIPs under FIFRA section 7 and have 

requested guidance on these matters. 

The Agency reviewed the concerns 

raised by industry and other 

stakeholders and reached the 

conclusion that, because of problems 

inherent in the application of the 

current regulations to this class of 

pesticides known as PIPs, EPA is 

unable to provide guidance. As written, 

the current regulations have been 

difficult to enforce with respect to PIPs. 

Ambiguity regarding the applicability 

of section 7 requirements makes it 

difficult for EPA and regulators in 

States and tribes to monitor production 

and subsequent distribution, sale and 

use of products, and can cause 

difficulties with respect to compliance 

inspection and enforcement. State and 

tribal involvement in compliance 

oversight can be greatly complicated by 

a lack of clear compliance 

requirements. This uncertainty may be 

resolved by a substantive modification 

of the regulations through rulemaking. 

Summary of Legal Basis: 

EPA has regulatory authority to 

promulgate regulations under FIFRA 

sections 3(a), 8(a), 25(a), and 25(b) (7 

U.S.C. 136a(a), 136f(a), 136w(a), and 

136w(b)). 

PIPs are pesticides under FIFRA section 

2 because they are introduced into 

plants with the intention of 

‘‘preventing, destroying, repelling, or 

mitigating any pest. . ..’’ (7 U.S.C. 

136(u)). 

Under FIFRA section 2, any person 

who manufactures, prepares, 

compounds, propagates or processes 

any pesticide is a ‘‘producer.’’ (7 U.S.C. 

136(w)). FIFRA section 7 requires that 

producers of pesticides register the 

establishments where production 

occurs and requires that producers 

report their annual production (7 U. S. 

C. 136e). In addition, FIFRA section 8 

provides that EPA may issue 

regulations requiring producers to 

maintain records with respect to their 

operations and to make such records 

available for inspection (7 U. S. C. 

136f). Under FIFRA section 9, 

appropriately credentialed inspectors 

have the authority to conduct 

inspections at pesticide producing 

establishments, or other places where 

pesticides are being held for 

distribution or sale, for the purpose of 

inspecting products, labels and records, 

and for obtaining samples (7 U. S. C. 

136g). 

FIFRA section 3(a) states that ‘‘[t]o the 

extent necessary to prevent 

unreasonable adverse effects on the 

environment, the Administrator may by 

regulation limit the distribution, sale, 

or use in any State of any pesticide 

that is not registered under this Act and 

that is not the subject of an 

experimental use permit under section 

5 or an emergency exemption under 

section 18.‘‘ 

FIFRA section 8(a) states that ’’[t]he 

Administrator may prescribe 

regulations requiring producers, 

registrants, and applicants for 

registration to maintain such records 

with respect to their operations and the 

pesticides and device produced as the 

Administrator determines are necessary 

for the effective enforcement of this Act 

and to make the records available for 

inspection and copying in the same 

manner as provided in [FIFRA section 

8(b)] .‘‘ 

FIFRA section 25(a) states that ’’[t]he 

Administrator is authorized in 

accordance with the procedure 

described in [sec. 25(a)(2) of the Act], 

to prescribe regulations to carry out the 

provisions of this Act. Such regulations 

shall take into account the difference 

in concept and usage between various 

classes of pesticides, including public 

health pesticides, and differences in 

environmental risk and the appropriate 

data for evaluating such risk between 

agricultural, nonagricultural, and public 

health pesticides.‘‘ 

FIFRA section 25(b) states that ’’[t]he 

Administrator may exempt from the 

requirements of this Act by regulation 

any pesticide which the Administrator 

determines either (1) to be adequately 

regulated by another Federal agency, or 

(2) to be of a character which is 

unnecessary to be subject to this Act 

in order to carry out the purposes of 

this Act.‘‘ 

Alternatives: 

Alternatives will be presented in the 

preamble to the proposed rule. 

Anticipated Cost and Benefits: 

The Agency is conducting an economic 

analysis to inform decisions for the 

proposed rule. Anticipated benefits 

include greater certainty and 


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transparency in terms of applicable 

requirements for these products. Since 

the proposed rulemaking is currently 

still under development, information 

about anticipated costs is not yet 

available. 

Risks: 

This rulemaking is not intended to 

address a specific risk associated with 

registered PIPs. However, facilitating 

compliance with FIFRA requirements 

could minimize potential risks 

associated with inadvertent 

noncompliance. In addition the 

rulemaking is intended to provide a 

means to identify and minimize risks 

associated with use of unregistered PIPs 

for production for export. 

Timetable: 

Action Date FR Cite 

ANPRM 04/04/07 72 FR 16312 

Notice of Public 

Meeting 

04/11/07 72 FR 18191 

ANPRM: Extension of 

Comment Period 

05/23/07 72 FR 28911 

ANPRM Comment 

Period End 

06/13/07 

ANPRM Comment 

Period Extended To 

07/13/07 

NPRM 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Federal, State, Tribal 

Additional Information: 

EPA publication information: ANPRM 

- http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

0900006480220026; EPA Docket 

information: EPA-HQ-OPP-2006-1003 

Sectors Affected: 

61131 Colleges, Universities and 

Professional Schools; 111 Crop 

Production; 32532 Pesticide and Other 

Agricultural Chemical Manufacturing; 

54171 Research and Development in 

the Physical Sciences and Engineering 

Sciences 

URL For More Information: 

http://www.epa.gov/pesticides/ 

biopesticides/pips/index.htm 

Agency Contact: 

Stephen Howie 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7201M 

Washington, DC 20460 

Phone: 202 564–4146 

Fax: 202 564–8502 

Email: howie.stephen@epa.gov 

Elizabeth Milewski 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7201M 

Washington, DC 20460 

Phone: 202 564–8480 

Fax: 202 564–8502 

Email: milewski.elizabeth@epa.gov 

RIN: 2070–AJ32 

EPA 

138. MERCURY; REGULATION OF 

USE IN CERTAIN PRODUCTS 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

15 USC 2605 

CFR Citation: 

40 CFR 750 

Legal Deadline: 

None 

Abstract: 

Mercury is well documented as a toxic, 

environmentally persistent substance 

that demonstrates the ability to 

bioaccumulate and to be 

atmospherically transported on a local, 

regional, and global scale. In addition, 

mercury can be environmentally 

transformed into methylmercury, which 

biomagnifies and is highly toxic. EPA 

has conducted a preliminary analysis 

via the Risk-Based Prioritization of 

Mercury in Certain Products. By 

compiling data pertaining to the stated 

costs, advantages, and disadvantages 

associated with mercury-free 

alternatives to certain mercurycontaining products, EPA made a 

preliminary judgment that effective and 

economically feasible alternatives exist. 

These products include switches, 

relays/contactors, flame sensors, button 

cell batteries, and measuring devices 

(e.g., non-fever thermometers, 

manometers, barometers, pyrometers, 

flow meters, and 

psychrometers/hygrometers). Therefore, 

EPA is evaluating whether an action (or 

combination of actions) under Toxic 

Substances Control Act (TSCA) is 

appropriate for mercury used in such 

products. As appropriate, such an 

action(s) would involve a group(s) of 

these products. Specifically, EPA will 

determine whether the continued use 

of mercury in one or more of these 

products would pose an unreasonable 

risk to human health and the 

environment. 

Statement of Need: 

Mercury is well documented as a toxic, 

environmentally persistent substance 

that demonstrates the ability to 

bioaccumulate and to be 

atmospherically transported on a local, 

regional, and global scale. In addition, 

mercury can be environmentally 

transformed into methylmercury, which 

biomagnifies and is highly toxic. 

Human health risks associated with 

elemental mercury and methylmercury 

are well documented. Humans can be 

exposed from products directly to 

elemental mercury vapor and indirectly 

through fish contaminated with 

methylmercury. EPA has conducted a 

preliminary analysis via the Risk-Based 

Prioritization of Mercury in Certain 

Products. By compiling data pertaining 

to the stated costs, advantages, and 

disadvantages associated with mercuryfree alternatives to certain mercurycontaining products, EPA made a 

preliminary judgment that effective and 

economically feasible alternatives exist. 

In its initial prioritization of mercury 

in certain products, EPA considered 

mercury’s well documented toxicity, 

persistence, ability to bioaccumulate, 

ability to be environmentally 

transformed into methylmercury, and 

its demonstrated ability to be 

transported globally as well as locally 

and the availability of effective and 

economically feasible alternatives for 

mercury in certain products. EPA 

believes manufacturing, processing, 

use, or disposal of elemental mercury 

in these products may result in 

significant potential for human and 

environmental exposures to elemental 

mercury and methylmercury. 

Summary of Legal Basis: 

EPA is evaluating whether an action (or 

combination of actions) under Toxic 

Substances Control Act (TSCA), 15 

U.S.C. 2601 et seq., is appropriate for 

mercury used in certain products. 

TSCA provides EPA with authority to 

require reporting, recordkeeping, and 


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testing requirements, and restrictions 

relating to chemical substances and/or 

mixtures. Specifically, section 4 

authorizes EPA to require testing of 

chemicals by manufacturers, importers, 

and processors where risks or 

exposures of concern are found. Section 

5 authorizes EPA to require prior notice 

by manufacturers, importers, and 

processors when it identifies a 

‘‘significant new use’’ that could result 

in exposures to, or releases of, a 

substance of concern. Section 6 gives 

EPA the authority to protect against 

unreasonable risk of injury to health or 

the environment from chemical 

substances. If EPA finds that there is 

a reasonable basis to conclude that the 

chemical’s manufacture, processing, 

distribution, use or disposal presents an 

unreasonable risk, EPA may by rule 

take action to: prohibit or limit 

manufacture, processing, or distribution 

in commerce; prohibit or limit the 

manufacture, processing, or distribution 

in commerce of the chemical substance 

above a specified concentration; require 

adequate warnings and instructions 

with respect to use, distribution, or 

disposal; require manufacturers or 

processors to make and retain records; 

prohibit or regulate any manner of 

commercial use; prohibit or regulate 

any manner of disposal; and/or require 

manufacturers or processors to give 

notice of the unreasonable risk of 

injury, and to recall products if 

required. Section 8 authorizes EPA to 

require reporting and recordkeeping by 

persons who manufacture, import, 

process, and/or distribute chemical 

substances in commerce. 

Alternatives: 

EPA has conducted a preliminary 

analysis via the Risk-Based 

Prioritization of Mercury in Certain 

Products. By compiling data pertaining 

to the stated costs, advantages, and 

disadvantages associated with mercuryfree alternatives to certain mercurycontaining products, EPA made a 

preliminary judgment that effective and 

economically feasible alternatives exist. 

Anticipated Cost and Benefits: 

As part of the economic, exposure, and 

risk assessment to support the current 

action, EPA is conducting a 

comprehensive use-substitute analysis 

and industry profile that will consider 

the costs and benefits of an action (or 

combination of actions) under Toxic 

Substances Control Act (TSCA). Those 

assessments consider the costs of 

mercury-containing and mercury-free 

alternatives and the impact that any 

action would have on potentially 

affected stakeholders, including 

economic, human health, and 

environmental criteria. 

Risks: 

As part of the economic, exposure, and 

risk assessment to support the current 

action, EPA is conducting a 

comprehensive use-substitute analysis 

and industry profile that will consider 

the risks associated with an action (or 

combination of actions) under Toxic 

Substances Control Act (TSCA). Those 

assessments consider the relative 

toxicity and other considerations 

associated with mercury-free 

alternatives to mercury-containing 

products and the impact that any action 

would have on potentially affected 

stakeholders, including economic, 

human health, and environmental 

criteria. 

Timetable: 

Action Date FR Cite 

NPRM 10/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Additional Information: 

SAN No. 5312 

URL For More Information: 

http://www.epa.gov/mercury/ 

Agency Contact: 

Thomas Groeneveld 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7404T 

Washington, DC 20460 

Phone: 202 566–1188 

Fax: 202 566–0469 

Email: groeneveld.thomas@epa.gov 

Lynn Vendinello 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7404T 

Washington, DC 20460 

Phone: 202 566–0514 

Fax: 202 566–0473 

Email: vendinello.lynn@epa.gov 

RIN: 2070–AJ46 

EPA 

139. NANOSCALE MATERIALS; 

REPORTING UNDER TSCA SECTION 

8(A) 

Priority: 

Other Significant 

Legal Authority: 

15 USC 2607(a) TSCA 8(a) 

CFR Citation: 

40 CFR 704 

Legal Deadline: 

None 

Abstract: 

Under section 8(a) of the Toxic 

Substances Control Act (TSCA), EPA is 

developing a proposal to establish 

reporting requirements for certain 

nanoscale materials. This rule would 

propose that persons who manufacture 

these nanoscale materials notify EPA of 

certain information including 

production volume, methods of 

manufacture and processing, exposure 

and release information, and available 

health and safety data. The proposed 

reporting of these activities will 

provide EPA with an opportunity to 

evaluate the information and consider 

appropriate action under TSCA to 

reduce any risk to human health or the 

environment. 

Statement of Need: 

EPA is proposing reporting 

requirements under section 8(a) of 

TSCA for persons who are 

manufacturing, importing, or processing 

existing nanoscale materials in 

commerce to collect data on these 


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activities. The data will help EPA to 

take any measures to ensure that 

nanoscale materials are manufactured 

and used in a manner that protects 

against unreasonable risks to human 

health and the environment. 

Summary of Legal Basis: 

Section 8(a) of TSCA authorizes the 

Administrator to promulgate rules, 

which require each person (other than 

a small manufacturer, importer, or 

processor) who manufactures, imports, 

processes, or proposes to manufacture, 

import, or process a chemical 

substance, to maintain such records 

and submit such reports as the 

Administrator may reasonably require. 

Alternatives: 

EPA developed a voluntary Nanoscale 

Materials Stewardship Program (NMSP) 

to complement and support its 

regulatory activities on nanoscale 

materials. EPA initiated the NMSP to 

quickly learn about commercially 

available nanoscale materials by 

soliciting existing data and information 

on a voluntary basis from 

manufacturers, importers, processors, 

and users of nanoscale materials. In 

addition, the program was designed to 

identify and encourage use of risk 

management practices in developing 

and commercializing nanoscale 

materials. In its NMSP interim report, 

EPA identified data gaps for existing 

nanoscale material production, uses, 

and exposures, based on the 

information EPA received prior to 

January 2009. For example, EPA 

estimated that companies provided 

information on only about 10 percent 

of the nanomaterials that may be 

commercially available. EPA is 

proposing reporting requirements under 

section 8(a) of TSCA for persons who 

are manufacturing, importing, or 

processing nanoscale materials in 

commerce to address some of the data 

gaps identified in the NMSP interim 

report. EPA has not identified any other 

activities, including regulatory 

activities under TSCA that would 

address data gaps for existing nanoscale 

materials. 

Anticipated Cost and Benefits: 

EPA has evaluated the potential costs 

of 8(a) reporting requirements for 

potential manufacturers, importers, and 

processors that would be subject to the 

proposed rule. If an entity were to 

submit a notice to the Agency, the 

annual burden is estimated to average 

157 hours per response. This 

information would facilitate EPA’s 

evaluation of the materials and 

consideration of appropriate action 

under TSCA to reduce any 

unreasonable risk to human health or 

the environment. 

Risks: 

There is a growing body of scientific 

evidence showing the differences that 

exist between nanoscale material(s) and 

their non-nanoscale counterpart(s). 

Nanoscale materials may have different 

or enhanced properties—for example, 

electrical, chemical, magnetic, 

mechanical, thermal, or optical 

properties—or features, such as 

improved hardness or strength, that are 

highly desirable for applications in 

commercial, medical, military, and 

environmental sectors. These properties 

are a direct consequence of small size, 

which results in a larger surface area 

per unit of volume and/or quantum 

effects that occur at the nanometer 

scale (i.e., 1 x 10-9 meters). Small size 

itself can also be a desirable property 

of nanoscale materials that is exploited 

for miniaturization of 

applications/processes and/or 

stabilization or delivery of payloads to 

diverse environments or incorporation 

into diverse products. 

The properties that can make nanoscale 

materials desirable for commercial 

applications also raise questions 

whether the small size of nanoscale 

materials or the unique or enhanced 

properties of nanoscale materials may, 

under specific conditions, pose new or 

increased hazards to humans and the 

environment. Government, academic, 

and private sector scientists in multiple 

countries are performing research into 

the environmental and human health 

effects of diverse nanoscale materials, 

resulting in a substantial and rapidly 

growing body of scientific evidence. 

These research findings point to the 

possibility for nanoscale materials to 

affect human health and the 

environment adversely. Research also 

indicates that not all materials in the 

nanoscale size range behave differently 

from larger sized materials of the same 

substance. 

Timetable: 

Action Date FR Cite 

NPRM 02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Additional Information: 

EPA Docket information: EPA—HQ— 

OPPT—2010-0572 

Sectors Affected: 

325 Chemical Manufacturing; 324 

Petroleum and Coal Products 

Manufacturing 

URL For More Information: 

http://www.epa.gov/oppt/nano/ 

Agency Contact: 

Jim Alwood 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7405M 

Washington, DC 20460 

Phone: 202 564–8974 

Email: alwood.jim@epa.gov 

Jessica Barkas 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7405M 

Washington, DC 20460 

Phone: 202 250–8880 

Email: barkas.jessica@epa.gov 

RIN: 2070–AJ54 

EPA 

140. NANOSCALE MATERIALS; 

SIGNIFICANT NEW USE RULE (SNUR) 

Priority: 

Other Significant 

Legal Authority: 

15 USC 2604 

CFR Citation: 

40 CFR 721 

Legal Deadline: 

None 

Abstract: 

EPA is developing a significant new 

use rule (SNUR) under section 5(a)(2) 

of the Toxic Substances Control Act 

(TSCA) for nanoscale materials. This 

action would require persons who 

intend to manufacture, import, or 

process this/these chemical 

substance(s) for an activity that is 

designated as a significant new use by 

this proposed rule to notify EPA at 

least 90 days before commencing that 

activity. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or 

limit that activity before it occurs to 

prevent unreasonable risk to human 

health or the environment. 


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Statement of Need: 

EPA is proposing a significant new use 

rule (SNUR) under section 5(a)(2) of 

TSCA that would designate as a 

significant new use, any use of 

chemical substances as nanoscale 

materials after the proposed date of the 

rule. Persons who intend to 

manufacture, import, or process these 

chemical substances for the new use 

after the date of the proposed rule 

would be required to notify EPA at 

least 90 days before commencing that 

activity. The required notification 

would provide EPA with the 

opportunity to evaluate the intended 

use and, if necessary, to prohibit or 

limit that activity before it occurs to 

prevent any unreasonable risks to 

human health or the environment. 

Summary of Legal Basis: 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is 

a ‘‘significant new use.’’ EPA must 

make this determination by rule after 

considering all relevant factors, 

including those listed in TSCA section 

5(a)(2). Once EPA determines that a use 

of a chemical substance is a significant 

new use, TSCA section 5(a)(1)(B) 

requires persons to submit a significant 

new use notice (SNUN) to EPA at least 

90 days before they manufacture, 

import, or process the chemical 

substance for that use (15 U.S.C. 

2604(a)(1)(B)). 

Alternatives: 

Nanoscale materials based on chemical 

substances already on the TSCA 

Inventory are considered existing 

chemical substances. These nanoscale 

materials do not require reporting as 

new chemical substances because they 

are nanoscale forms of chemical 

substances already in commerce. If EPA 

does not use authority under 5(a)(2) of 

TSCA to require notification of new 

uses of nanoscale materials, EPA would 

have to use existing chemical authority 

under sections 4, 6, and 8 of TSCA to 

gather data and address any 

unreasonable risks. 

Anticipated Cost and Benefits: 

EPA has evaluated the potential costs 

of reporting requirements for potential 

manufacturers, importers, and 

processors that would be subject to the 

significant new use rule. If an entity 

were to submit a notice to the Agency, 

the annual burden is estimated to 

average 95 hours per response. The 

required notification would provide 

EPA with the opportunity to evaluate 

the intended use and, if necessary, to 

prohibit or limit that activity before it 

occurs to prevent any unreasonable 

risks to human health or the 

environment. 

Risks: 

There is a growing body of scientific 

evidence showing the differences that 

exist between nanoscale material(s) and 

their non-nanoscale counterpart(s). 

Nanoscale materials may have different 

or enhanced properties—for example, 

electrical, chemical, magnetic, 

mechanical, thermal, or optical 

properties—or features, such as 

improved hardness or strength, that are 

highly desirable for applications in 

commercial, medical, military, and 

environmental sectors. These properties 

are a direct consequence of small size, 

which results in a larger surface area 

per unit of volume and / or quantum 

effects that occur at the nanometer 

scale (i.e., 1 x 10-9 meters). Small size 

itself can also be a desirable property 

of nanoscale materials that is exploited 

for miniaturization of 

applications/processes and/or 

stabilization or delivery of payloads to 

diverse environments or incorporation 

into diverse products. 

The properties that can make nanoscale 

materials desirable for commercial 

applications also raise questions 

whether the small size of nanoscale 

materials or the unique or enhanced 

properties of nanoscale materials may, 

under specific conditions, pose new or 

increased hazards to humans and the 

environment. Government, academic, 

and private sector scientists in multiple 

countries are performing research into 

the environmental and human health 

effects of diverse nanoscale materials, 

resulting in a substantial and rapidly 

growing body of scientific evidence. 

These research findings point to the 

possibility for nanoscale materials to 

affect human health and the 

environment adversely. Research also 

indicates that not all materials in the 

nanoscale size range behave differently 

from larger sized materials of the same 

substance. 

Timetable: 

Action Date FR Cite 

NPRM 02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Additional Information: 

EPA Docket information: EPA—HQ— 

OPPT—2010-0572 

URL For More Information: 

http://www.epa.gov/oppt/nano/ 

Agency Contact: 

Jim Alwood 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7405M 

Washington, DC 20460 

Phone: 202 564–8974 

Email: alwood.jim@epa.gov 

Jessica Barkas 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7405M 

Washington, DC 20460 

Phone: 202 250–8880 

Email: barkas.jessica@epa.gov 

RIN: 2070–AJ67 

EPA 

141. ∑ REVISIONS TO EPA’S RULE ON 

PROTECTIONS FOR SUBJECTS IN 

HUMAN RESEARCH INVOLVING 

PESTICIDES 

Priority: 

Other Significant 

Legal Authority: 

PL 109–54, sec 201; 5 USC 301; 42 USC 

300v–1(b); 7 USC 136 to 136y; 21 USC 

346a 

CFR Citation: 

40 CFR 26 

Legal Deadline: 

NPRM, Judicial, January 18, 2011, 

Settlement Agreement Deadline for the 

Administrator’s Signature. 

Final, Judicial, December 18, 2011, 

Settlement Agreement Deadline for the 

Administrator’s Signature. 

Abstract: 

As part of a settlement agreement, EPA 

will propose revisions to the existing 

rule governing the protection of 

subjects in human research involving 

pesticides. The current rule, issued in 

2006, provides protections for subjects 

in human research by (1) prohibiting 

research conducted or supported by 

EPA that would involve intentional 

exposure of human subjects who are 

children or pregnant or nursing women; 

(2) prohibiting EPA reliance in actions 

under the pesticide laws on research 


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involving intentional exposure of 

children or pregnant or nursing women; 

(3) extending the substantive 

requirements of the Common Rule to 

the design and execution of research 

conducted by third-parties who intend 

to submit the data to EPA under the 

pesticide laws; and (4) establishing the 

Human Studies Review Board, an 

independent expert panel to review 

proposals for new research and reports 

of covered human research on which 

EPA proposes to rely under the 

pesticide laws. In settling this 

litigation, EPA agreed to propose to 

broaden the applicability of the 2006 

rule to apply to research involving 

intentional exposure of a human 

subject to ‘‘a pesticide,’’ without 

limitation as to the regulatory statutes 

under which the data might be 

submitted, considered, or relied upon. 

The new proposed rule, therefore, 

would apply to all research with 

‘‘pesticides,’’ as that term is defined in 

7 U.S.C. 136(u) [Federal Insecticide, 

Fungicide and Rodenticide Act 

(FIFRA), sec. 2(u)], submitted, 

considered, or relied upon under any 

regulatory statute that EPA administers. 

EPA also committed in the settlement 

agreement to propose amendments to 

the rule that would disallow consent 

by an authorized representative of a test 

subject and that would require the 

Agency, in its reviews of covered 

human research, to document its ethics 

and science considerations in terms of 

the recommendations articulated in the 

National Research Council’s 2004 

report, Intentional Human Dosing 

Studies for EPA Regulatory Purposes. 

Statement of Need: 

In 2006, EPA promulgated a regulation 

governing the protection of subjects in 

human research involving pesticides. 

EPA settled litigation challenging the 

2006 rule by promising to conduct this 

rulemaking. 

Summary of Legal Basis: 

Public Law 109-54, section 201; 5 

U.S.C. 301; 42 U.S.C. 300v-1(b); 7 

U.S.C. 136 to 136y; 21 U.S.C. 346a 

Alternatives: 

This action involves proposal of 

amendments to the 2006 rule consistent 

with a negotiated settlement, followed 

by receipt and response to public 

comments and promulgation of a final 

rule. Because alternative educational, 

voluntary, incentive-based, marketbased, or other non-regulatory 

approaches could not resolve the legal 

challenge to the 2006 rule, they are not 

being considered. EPA retains 

discretion to adopt a final rule that 

differs from its proposal. 

Anticipated Cost and Benefits: 

Impacts are expected to be primarily 

procedural and limited to the costs of 

supporting the rulemaking effort itself. 

Expected benefits from this action will 

result from resolution of the litigation 

and establishing the stability of the 

rules governing regulated human 

research with pesticides by third 

parties. 

Risks: 

Although no research is known of that 

would fall outside the scope of the 

2006 rule but within the scope of the 

proposed amendment, this action 

addresses a perceived loophole for 

unethical human pesticide research to 

be submitted to EPA and relied on by 

the Agency under other regulatory 

statutes. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

Final Action 12/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal 

URL For More Information: 

http://www.epa.gov/oppfead1/ 

guidance/human-test.htm 

Agency Contact: 

John Carley 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7501P 

Washington, DC 20460 

Phone: 703 305–7019 

Fax: 703 308–4776 

Email: carley.john@epa.gov 

William Jordan 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7501P 

Washington, DC 20460 

Phone: 703 305–1049 

Fax: 703 308–4776 

Email: jordan.william@epa.gov 

RIN: 2070–AJ76 

EPA 

142. HAZARDOUS WASTE 

MANAGEMENT SYSTEMS: 

IDENTIFICATION AND LISTING OF 

HAZARDOUS WASTE: CARBON 

DIOXIDE (CO2) INJECTATE IN 

GEOLOGICAL SEQUESTRATION 

ACTIVITIES 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

42 USC 6903; 42 USC 6912; 42 USC 

6921–24 

CFR Citation: 

40 CFR 261 

Legal Deadline: 

None 

Abstract: 

On July 25, 2008, EPA published a 

proposed rule under the Safe Drinking 

Water Act Underground Injection 

Control Program to create a new class 

of injection wells (Class VI) for 

geological sequestration (GS) of carbon 

dioxide (CO2). 73 FR 43492. In 

response to that proposal, EPA received 

numerous comments asking for 

clarification on how the Resource 

Conservation and Recovery Act (RCRA) 

hazardous waste requirements apply to 

CO2 streams. EPA is now considering 

a proposed rule under RCRA to explore 

a number of options, including a 

conditional exemption from the RCRA 

requirements for hazardous CO2 

streams in order to facilitate 

implementation of GS, while protecting 

human health and the environment. 

Statement of Need: 

The Agency is taking this action in 

order to reduce the uncertainty 

associated with managing CO2 streams 

under RCRA subtitle C, which will 

enable the continued research and 

deployment of carbon capture storage 

activities. 

Summary of Legal Basis: 

EPA expects the regulations to be 

proposed under the authority of 

sections 1004, 2002, 3001, 3002, 3003, 

and 3004 of RCRA, 42 U.S.C. 6903, 

6912, 6921, 6922, 6923, and 6924. 

Alternatives: 

EPA intends to analyze options for 

clarifying the applicability of RCRA 

subtitle C to CO2 streams being 


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captured, transported, and sequestered 

in Class VI UIC wells, including a 

conditional exemption from the 

hazardous waste regulations. 

Anticipated Cost and Benefits: 

The economic impact assessment for 

this action is presently under 

development, and there are no 

preliminary estimates of costs or 

benefits at this time. 

Risks: 

EPA intends to evaluate how 

requirements under other statutes and 

programs (for example, Department of 

Transportation (DOT) regulations, and 

EPA’s Underground Injection Control 

Class VI rule) may adequately address 

potentially unacceptable risks from the 

capture, transport, and geologic 

sequestration of CO2 streams. 

Therefore, EPA does not expect to 

perform a separate risk assessment of 

those CO2 streams. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Federal, State 

Sectors Affected: 

31-33 Manufacturing; 48-49 

Transportation; 22 Utilities 

Agency Contact: 

Ross Elliott 

Environmental Protection Agency 

Solid Waste and Emergency Response 

5304P 

Washington, DC 20460 

Phone: 703 308–8748 

Fax: 703 605–0594 

Email: elliott.ross@epa.gov 

Mark Baldwin 

Environmental Protection Agency 

Solid Waste and Emergency Response 

5304P 

Washington, DC 20460 

Phone: 703 308–0157 

Email: baldwin.mark@epa.gov 

RIN: 2050–AG60 

EPA 

143. ∑ FINANCIAL RESPONSIBILITY 

REQUIREMENTS UNDER CERCLA 

SECTION 108(B) FOR CLASSES OF 

FACILITIES IN THE HARD ROCK 

MINING INDUSTRY 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

42 USC 9601 et seq.; 42 USC 9608 (b) 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

Section 108(b) of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act 

(CERCLA) of 1980, as amended, 

establishes certain authorities 

concerning financial responsibility 

requirements. The Agency has 

identified classes of facilities within the 

Hard Rock mining industry as those for 

which financial responsibility 

requirements will be first developed. 

EPA intends to include requirements 

for financial responsibility, as well as 

notification and implementation. 

Statement of Need: 

The Agency is currently examining 

various classes of facilities that may 

produce, transport, treat, store or 

dispose of hazardous substances for 

development of financial responsibility 

requirements under CERCLA section 

108(b). 

Summary of Legal Basis: 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended. 

Alternatives: 

To be determined. 

Anticipated Cost and Benefits: 

To be determined. 

Risks: 

To be determined. 

Timetable: 

Action Date FR Cite 

Priority Notice 07/28/09 74 FR 37213 

NPRM 04/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Additional Information: 

EPA publication information: Priority 

Notice - 

http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

09000064809fc1ff; Split from RIN 2050- 

AG56.; EPA Docket information: EPAHQ-SFUND-2009-0834 

Sectors Affected: 

212 Mining (except Oil and Gas) 

Agency Contact: 

Ben Lesser 

Environmental Protection Agency 

Solid Waste and Emergency Response 

5302P 

Washington, DC 20460 

Phone: 703 308–0314 

Email: lesser.ben@epa.gov 

David Hockey 

Environmental Protection Agency 

Solid Waste and Emergency Response 

5303P 

Washington, DC 20460 

Phone: 703 308–8846 

Email: hockey.david@epa.gov 

RIN: 2050–AG61 

EPA 

144. NPDES PERMIT REQUIREMENTS 

FOR MUNICIPAL SANITARY AND 

COMBINED SEWER COLLECTION 

SYSTEMS, MUNICIPAL SATELLITE 

COLLECTION SYSTEMS, SANITARY 

SEWER OVERFLOWS, AND PEAK 

EXCESS FLOW TREATMENT 

FACILITIES 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

33 USC 1311 CWA 301; 33 USC 1314 

CWA 304; 33 USC 1318 CWA 308; 33 

USC 1342 CWA 402; 33 USC 1361 

CWA 501(a) 

CFR Citation: 

40 CFR 122.38; 40 CFR 122.41; 40 CFR 

122.42 


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Legal Deadline: 

None 

Abstract: 

EPA will develop a notice of proposed 

rulemaking outlining a broad-based 

regulatory framework for sanitary sewer 

collection systems under the NPDES 

program. The Agency is considering 

proposing standard permit conditions 

for inclusion in permits for publicly 

owned treatment works (POTWs) and 

municipal sanitary sewer collection 

systems. The standard requirements 

would address reporting, public 

notification, and recordkeeping 

requirements for sanitary sewer 

overflows (SSOs), capacity assurance, 

management, operation, and 

maintenance requirements for 

municipal sanitary sewer collection 

systems; and a prohibition on SSOs. 

The Agency is also considering 

proposing a regulatory framework for 

applying NPDES permit conditions, 

including applicable standard permit 

conditions, to municipal satellite 

collection systems. Municipal satellite 

collection systems are sanitary sewers 

owned or operated by a municipality 

that conveys wastewater to a POTW 

operated by a different municipality. 

Statement of Need: 

EPA is developing a rule to modify the 

National Pollutant Discharge 

Elimination System regulations as they 

apply to municipal sanitary sewer 

collection systems and sanitary sewer 

overflows in order to better protect the 

environment and public health from 

the harmful effects of sanitary sewer 

overflows and basement back ups. 

Summary of Legal Basis: 

The Agency is undertaking this effort 

to help advance the Clean Water Act 

objective to restore and maintain the 

chemical, physical, and biological 

integrity of the Nation’s waters (CWA, 

sec. 101 (a)). 

Alternatives: 

EPA will consider a variety of options 

during the rulemaking process. 

Anticipated Cost and Benefits: 

EPA will consider anticipated costs and 

benefits during the rulemaking process. 

Risks: 

EPA will consider potential risks 

during the rulemaking process. 

Timetable: 

Action Date FR Cite 

Notice—Public 

Meeting 

06/01/10 75 FR 30395 

Action Date FR Cite 

NPRM 11/00/11 

Final Action 11/00/12 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Small Entities Affected: 

Governmental Jurisdictions 

Government Levels Affected: 

Federal, Local, State, Tribal 

Federalism: 

Undetermined 

Additional Information: 

EPA Docket information: EPA—HQ— 

OW— 2010—0464 

Sectors Affected: 

22132 Sewage Treatment Facilities 

URL For More Information: 

www.epa.gov/npdes 

Agency Contact: 

Kevin Weiss 

Environmental Protection Agency 

Water 

4203M 

Washington, DC 20460 

Phone: 202 564–0742 

Fax: 202 564–6392 

Email: weiss.kevin@epa.gov 

Mohammed Billah 

Environmental Protection Agency 

Water 

4203M 

Washington, DC 20460 

Phone: 202 564–0729 

Fax: 202 564–0717 

Email: 

billah.mohammed@epamail.epa.gov 

RIN: 2040–AD02 

EPA 

145. CRITERIA AND STANDARDS FOR 

COOLING WATER INTAKE 

STRUCTURES 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

CWA 101; CWA 308; CWA 316; CWA 

402; CWA 501; CWA 510 

CFR Citation: 

40 CFR 9; 40 CFR 122; 40 CFR 123; 

40 CFR 124; 40 CFR 125 

Legal Deadline: 

None 

Abstract: 

Section 316(b) of the Clean Water Act 

(CWA) requires EPA to ensure that the 

location, design, construction, and 

capacity of cooling water intake 

structures reflect the best technology 

available (BTA) for minimizing adverse 

environmental impacts. In developing 

regulations to implement section 

316(b), EPA divided its effort into three 

rulemaking phases. Phase II, for 

existing electric generating plants that 

use at least 50 MGD of cooling water, 

was completed in July 2004. Industry 

and environmental stakeholders 

challenged the Phase II regulations. On 

review, the U.S. Court of Appeals for 

the Second Circuit remanded several 

key provisions. In July 2007, EPA 

suspended Phase II. Following the 

decision in the Second Circuit, several 

parties petitioned the U.S. Supreme 

Court to review that decision, and the 

Supreme Court granted the petitions, 

limited to the issue of whether the 

Clean Water Act authorized EPA to 

consider the relationship of costs and 

benefits in establishing section 316(b) 

standards. On April 1, 2009, the 

Supreme Court reversed the Second 

Circuit, finding that the Agency may 

consider cost-benefit analysis in its 

decisionmaking but not holding that 

the Agency must consider costs and 

benefits in these decisions. In June 

2006, EPA promulgated the Phase III 

regulation, covering existing electric 

generating plants using less than 50 

MGD of cooling water, new offshore oil 

and gas facilities, and all existing 

manufacturing facilities. Petitions to 

review this rule were filed in the U.S. 

Court of Appeals for the Fifth Circuit. 

EPA has asked for, and was granted a 

partial voluntary remand of the 

determinations in the Phase III 

regulation concerning existing facilities, 

in order to issue a regulation that 

addresses both Phase II and III existing 

facilities. EPA expects this new 

rulemaking would apply to the 

approximately 1,200 existing electric 

generating and manufacturing plants. 

Statement of Need: 

In the absence of national regulations, 

NPDES permit writers have developed 

requirements to implement section 

316(b) on a case-by-case basis. This 

may result in a range of different 

requirements, and, in some cases, 

delays in permit issuance or reissuance. 

This regulation may have substantial 

ecological benefits. 


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Summary of Legal Basis: 

The Clean Water Act requires EPA to 

establish best technology available 

standards to minimize adverse 

environmental impacts from cooling 

water intake structures. On February 

16, 2004, EPA took final action on 

regulations governing cooling water 

intake structures at certain existing 

power producing facilities under 

section 316(b) of the Clean Water Act 

(Phase II rule). 69 FR 41576 (Jul. 9, 

2004). These regulations were 

challenged , and the Second Circuit 

remanded several provisions of the 

Phase II rule on various grounds. 

Riverkeeper, Inc. v. EPA, 475F.3d83, 

(2d Cir., 2007). EPA suspended most 

of the rule in response to the remand. 

72 FR 37107 (Jul. 9, 2007). The remand 

of Phase III does not change permitting 

requirements for these facilities. Until 

the new rule is issued, permit directors 

continue to issue permits on a caseby-case, Best Professional Judgment 

basis for Phase II facilities. 

Alternatives: 

This analysis will cover various sizes 

and types of potentially regulated 

facilities, and control technologies. EPA 

is considering whether to regulate on 

a national basis, by subcategory, by 

broad water body category, or some 

other basis. 

Anticipated Cost and Benefits: 

The technologies under consideration 

in this rulemaking are similar to the 

technologies considered for the original 

Phase II and Phase III rules. Those costs 

evaluated for the Phase II remanded 

rule, in 2002 dollars, ranged from $389 

million (the final rule option) to $440 

million (the final rule option at 

proposal) to $1 billion to $3.5 billion 

(closed cycle cooling for facilities on 

certain waterbodies, or at all facilities). 

The monetized benefits of the original 

final rule were estimated to be $82 

million. The monetized benefits 

include only the use value associated 

with quantifiable increases in 

commercial and recreational fisheries. 

Non-use benefits were not analyzed. 

The costs and benefits of the Phase III 

option most closely aligned with the 

Phase II option co-promulgated were 

$38.3 million and $2.3 million 

respectively, in 2004 dollars. EPA will 

develop new costs and benefits 

estimates for this new effort. 

Risks: 

Cooling water intake structures may 

pose significant risks for aquatic 

ecosystems. 

Timetable: 

Action Date FR Cite 

NPRM 02/00/11 

Final Action 07/00/12 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Federal, Local, State 

Federalism: 

Undetermined 

Additional Information: 

EPA Docket information: EPA-HQ-OW2008-0667 

URL For More Information: 

www.epa.gov/waterscience/316b 

Agency Contact: 

Paul Shriner 

Environmental Protection Agency 

Water 

4303T 

Washington, DC 20460 

Phone: 202 566–1076 

Email: shriner.paul@epamail.epa.gov 

Erik Helm 

Environmental Protection Agency 

Water 

4303T 

Washington, DC 20460 

Phone: 202 566–1049 

Email: helm.erik@epamail.epa.gov 

RIN: 2040–AE95 

EPA 

146. STORMWATER REGULATIONS 

REVISION TO ADDRESS 

DISCHARGES FROM DEVELOPED 

SITES 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

33 USC 1251 et seq 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

NPRM, Judicial, September 30, 2011, 

Chesapeake Bay Settlement Agreement; 

May 11, 2010; Fowler v US EPA, No 

1 :09–CV –00005–CKK (D DC). 

Final, Judicial, November 19, 2012, 

Chesapeake Bay Settlement Agreement; 

May 11, 2010; Fowler v US EPA, No 

1 :09–CV –00005–CKK (D DC). 

Abstract: 

Stormwater discharge from developed 

areas is a major cause of degradation 

of surface waters. This is true for both 

conveyance of pollutants and the 

erosive power of increased stormwater 

flow rates and volumes. Current 

stormwater regulations were 

promulgated in 1990 and 1999. In 2006, 

the Office of Water asked the National 

Research Council (NRC) to review the 

stormwater program and recommend 

ways to strengthen it. The NRC Report, 

which was finalized in October 2008, 

found that the current stormwater 

program ‘‘. . .is not likely to adequately 

control stormwater’s contribution to 

waterbody impairment’’ and 

recommended that EPA take action to 

address the harmful effects of 

stormwater flow. This proposed action 

would establish requirements for, at 

minimum, managing stormwater 

discharges from newly developed and 

re-developed sites, to reduce the 

amount of pollutants in stormwater 

discharges entering receiving waters by 

reducing the discharge of excess 

stormwater. This action may also 

expand the scope of municipal separate 

storm sewer systems (MS4) required to 

be regulated under NPDES permits, to 

include rapidly developing areas and to 

cover some discharges that are not 

currently regulated. The Phase I and 

Phase II MS4 regulations might also be 

combined and amended, and may 

include provisions for retrofitting 

existing development. In order to 

comply with the Executive order issued 

by President Obama on Mat 12, 2010, 

that among other things, require EPA 

to identify ways to strengthen 

stormwater management practices 

within the Bay watershed in order to 

restore and protect the Bay and its 

tributaries. EPA plans to include in this 

proposed rulemaking a separate section 

containing additional stormwater 

provisions for the Chesapeake Bay 

Watershed. 

Statement of Need: 

Section 402(p) of the Clean Water Act 

requires EPA to regulate certain 

stormwater discharges. Stormwater is a 

primary contributor of water quality 

impairment. There is a need to 

strengthen the stormwater program’s 

effectiveness by reducing pollutant 

loading from currently regulated and 

unregulated stormwater discharges and 

preserving surface water health and 

integrity. This action was informed by 


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the 2006 National Research Council 

report. 

Summary of Legal Basis: 

Section 402(p) of the Clean Water Act 

requires EPA to regulate certain 

discharges from stormwater in order to 

protect water quality. 

Alternatives: 

To be determined. 

Anticipated Cost and Benefits: 

To be determined. 

Risks: 

To be determined. 

Timetable: 

Action Date FR Cite 

NPRM 09/00/11 

Final Action 12/00/12 

Notice—Public 

Meeting 

To Be Determined 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions 

Government Levels Affected: 

Federal, Local, State 

Federalism: 

Undetermined 

Additional Information: 

EPA Docket information: EPA-HQ-OW2009-0817-0319 

URL For More Information: 

www.epa.gov/npdes/stormwater/ 

rulemaking 

Agency Contact: 

Connie Bosma 

Environmental Protection Agency 

Water 

4203M 

Washington, DC 20460 

Phone: 202 564–6773 

Fax: 202 564–6392 

Email: bosma.connie@epamail.epa.gov 

Janet Goodwin 

Environmental Protection Agency 

Water 

4203M 

Washington, DC 20460 

Phone: 202 566–1060 

Email: goodwin.janet@epamail.epa.gov 

RIN: 2040–AF13 

EPA 

147. NATIONAL POLLUTANT 

DISCHARGE ELIMINATION SYSTEM 

(NPDES) PERMIT REGULATIONS FOR 

NEW DISCHARGERS AND THE 

APPROPRIATE USE OF OFFSETS 

WITH REGARD TO WATER QUALITY 

PERMITTING 

Priority: 

Other Significant 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

33 USC 1361; 33 USC 1311(b)(1)(C) 

CFR Citation: 

40 CFR 122.4(i) 

Legal Deadline: 

None 

Abstract: 

This rulemaking may consider how to 

best clarify EPA’s approach to 

permitting new dischargers in order to 

ensure the protection of water quality 

under Clean Water Act section 

301(b)(1)(C). The rulemaking may 

examine options to address the 

appropriate and permissible use of 

offsets, which ensures that NPDES 

permits are protective of water quality 

standards. The rulemaking may also 

examine options for addressing new 

dischargers in impaired waters, both 

when a TMDL is in place and prior 

to TMDL issuance. 

Statement of Need: 

The EPA is initiating a rulemaking to 

consider clarifying the EPA’s 

interpretation of 40 CFR section 

122.4(i) and addressing the adverse 

Ninth Circuit decision in Friends of 

Pinto Creek v. EPA (2007), which 

created uncertainty regarding the 

permitting of new dischargers. Through 

this rulemaking, EPA will consider how 

to best ensure that the requirements at 

40 CFR 122.4(i) and/or related 

regulations pertaining to the permitting 

of new dischargers are consistent with 

Clean Water Act (CWA) requirements. 

Summary of Legal Basis: 

Clean Water Act (CWA) section 

301(b)(1)(C) requires permits to include 

limitation as stringent as necessary to 

meet water quality standards. The 

Federal regulations at 40 CFR 122.4(i) 

implements that requirement for new 

dischargers. 

Alternatives: 

TBD 

Anticipated Cost and Benefits: 

TBD 

Risks: 

TBD 

Timetable: 

Action Date FR Cite 

NPRM 04/00/11 

Final Action 01/00/12 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

Federalism: 

Undetermined 

Additional Information: 

SAN No. 5240 

Agency Contact: 

Sara Hilbrich 

Environmental Protection Agency 

Water 

4203M 

Washington, DC 20460 

Phone: 202 564–0441 

Email: hilbrich.sara@epamail.epa.gov 

Michelle Schutz 

Environmental Protection Agency 

Water 

4203M 

Washington, DC 20460 

Phone: 202 564–7374 

Email: schutz.michelle@epamail.epa.gov 

RIN: 2040–AF17 

EPA 

148. ∑ CONCENTRATED ANIMAL 

FEEDING OPERATIONS (CAFO) 

INFORMATION COLLECTION 

REQUEST RULE 

Priority: 

Other Significant 

Legal Authority: 

Not Yet Determined 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

Under the authority of section 308 of 

the CWA, EPA is proposing a rule to 

collect facility information from all 

Concentrated Animal Feeding 

Operations (CAFOs), which will 


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provide a CAFO inventory and assist 

in implementing the 2008 CAFO rule. 

Statement of Need: 

Under the authority of section 308 of 

the CWA, EPA is proposing a rule to 

collect facility information from all 

CAFOs, which will provide a CAFO 

inventory and assist in implementing 

the 2008 CAFO rule. 

Summary of Legal Basis: 

EPA is proposing a rule to collect 

facility information from all CAFOs 

under the authority of section 308 of 

the CWA. 

Timetable: 

Action Date FR Cite 

NPRM 05/00/11 

Final Action 05/00/12 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Undetermined 

Agency Contact: 

Becky Mitschele 

Environmental Protection Agency 

Water 

4203M 

Washington, DC 20460 

Phone: 202 564–6418 

Email: mitschele.becky@epamail.epa.gov 

George Utting 

Environmental Protection Agency 

Water 

4203M 

Washington, DC 20460 

Phone: 202 564–0744 

Email: utting.george@epa.gov 

RIN: 2040–AF22 

EPA 

FINAL RULE STAGE 

149. NATIONAL EMISSION 

STANDARDS FOR HAZARDOUS AIR 

POLLUTANTS FOR AREA SOURCES: 

INDUSTRIAL, COMMERCIAL, AND 

INSTITUTIONAL BOILERS 

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: 

Clean Air Act sec 112 

CFR Citation: 

40 CFR 63 

Legal Deadline: 

NPRM, Judicial, May 7, 2010, 60–day 

extension granted on July 30, 2009. 

Additional 2–week extension was 

subsequently granted, and the signature 

date was April 29, 2010. 

Final, Judicial, January 16, 2011, 

30–day extension granted from 

December 16, 2010. 

Abstract: 

The Clean Air Act (CAA) requires that 

EPA develop standards for toxic air 

pollutants, also known as hazardous air 

pollutants or air toxics for certain 

categories of sources. These pollutants 

are known or suspected to cause cancer 

and other serious health and 

environmental effects. This regulatory 

action will develop emission standards 

for boilers located at area sources. An 

area source facility emits or has the 

potential to emit less than 10 tons per 

year (tpy) of any single air toxic or less 

than 25 tpy of any combination of air 

toxics. Boilers burn coal and other 

substances such as oil or biomass (e.g., 

wood) to produce steam or hot water, 

which is then used for energy or heat. 

Industrial boilers are used in 

manufacturing, processing, mining, 

refining, or any other industry. 

Commercial and institutional boilers 

are used in commercial establishments, 

medical centers, educational facilities 

and municipal buildings. The majority 

of area source boilers covered by this 

proposed rule are located at 

commercial and institutional facilities 

and are generally owned or operated 

by small entities. EPA estimates that 

there are approximately 183,000 

existing area source boilers at 91,000 

facilities in the United States and that 

approximately 6,800 new area source 

boilers will be installed over the next 

3 years. The rule will cover boilers 

located at area source facilities that 

burn coal, oil, biomass, or secondary 

‘‘non-waste’’ materials. Natural gasfired area source boilers are not part 

of the categories to be regulated. The 

rule will reduce emissions of a number 

of toxic air pollutants including 

mercury, metals, and organic air toxics. 

The standards for area sources must be 

technology-based. Standards for area 

sources can be based on either 

generally available control technology 

(GACT), or maximum achievable 

control technology (MACT). To 

determine GACT, we look at methods, 

practices and techniques that are 

commercially available and appropriate 

for use by the sources in the category. 

We consider the economic impacts on 

sources in the category and the 

technical capabilities of the firms to 

operate and maintain the emissions 

control systems. MACT can be based 

on the emissions reductions achievable 

through application of measures, 

processes, methods, systems, or 

techniques, but must at least meet 

minimum control levels as defined in 

the Clean Air Act. Economic impacts 

cannot be considered when 

determining those minimum control 

levels. 

Statement of Need: 

Section 112(c)(3) of the CAA requires 

EPA to develop rules to reduce specific 

air toxics emissions (30 urban toxic 

pollutants) that have been identified as 

posing the greatest threat to public 

health in the largest number of urban 

areas as a result of emissions from 

certain categories of area sources. 

Industrial boilers and 

institutional/commercial boilers are 

listed as two of the area source 

categories for regulation. In addition, 

both industrial boilers and 

commercial/institutional boilers are on 

the list of CAA 112(c)(6) source 

categories which requires that those 

categories be subject to MACT 

regulation for specific air toxics. These 

two categories were included on the list 

because of emissions of mercury and 

polycyclic organic matter (POM). 

Summary of Legal Basis: 

Clean Air Act, section 112. 

Alternatives: 

Not yet determined. 

Anticipated Cost and Benefits: 

EPA estimates the total nationwide 

capital cost for the rulemaking for 

existing and new boilers, as proposed, 

to be approximately $2.5 billion, with 

an annualized cost of 1 billion. The 

annual cost includes control device 

operation and maintenance and annual 

boiler tuneups, as well as monitoring, 

recordkeeping, reporting, and 

performance testing. EPA estimates that 

the proposal would reduce nationwide 

emissions from existing and new area 

source boilers by approximately 1,500 

tons per year (tpy) of total air toxics, 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79662 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

1,500 pounds per year of mercury, 250 

tpy of non-mercury metals, 9 tpy of 

POM, and 7,600 tpy of PM. These 

emissions reductions will lead to 

significant annual health benefits. In 

2013, this rule will protect public 

health by avoiding: 110 to 300 

premature deaths, 81 cases of chronic 

bronchitis, 190 nonfatal heart attacks, 

169 hospital and emergency room 

visits, 190 cases of acute bronchitis, 

16,000 days when people miss work, 

2,100 cases of aggravated asthma, and 

95,000 acute respiratory symptoms. The 

monetized benefits of this proposed 

regulatory action are estimated to range 

from $1 billion to $2.4 billion and $900 

million to $2.2 billion, at 3 percent and 

7 percent discount rates, respectively. 

Risks: 

Not yet determined. 

Timetable: 

Action Date FR Cite 

NPRM 06/04/10 75 FR 31895 

NPRM Extension of 

Comment Period 

06/09/10 75 FR 32682 

NPRM Comment 

Period End 

07/19/10 

NPRM Comment 

Period Extended To 

08/03/10 

Final Action 01/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions, 

Organizations 

Government Levels Affected: 

Federal, Local, State, Tribal 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Additional Information: 

EPA publication information: NPRM - 

http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

0900006480afbb98; Related to RIN 

2060-AQ25.; EPA Docket information: 

EPA-HQ-OAR-2006-0790 

Sectors Affected: 

611 Educational Services; 62 Health 

Care and Social Assistance; 44-45 Retail 

Trade; 321 Wood Product 

Manufacturing 

Agency Contact: 

Mary Johnson 

Environmental Protection Agency 

Air and Radiation 

D243–01 

Research Triangle Park, NC 27711 

Phone: 919 541–5025 

Email: johnson.mary@epa.gov 

Robert J Wayland 

Environmental Protection Agency 

Air and Radiation 

C439–01 

Research Triangle Park, NC 27711 

Phone: 919 541–1045 

Email: wayland.robertj@epamail.epa.gov 

Related RIN: Related to 2060–AQ25 

RIN: 2060–AM44 

EPA 

150. TRANSPORT RULE (CAIR 

REPLACEMENT 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 7401 et seq 

CFR Citation: 

40 CFR 51, 52, 72, 78, 97 

Legal Deadline: 

None 

Abstract: 

On May 12, 2005, the Environmental 

Protection Agency (EPA) promulgated 

the Clean Air Interstate Rule, 

commonly known as CAIR (70 FR 

25162). The CAIR used a cap and trade 

approach to reduce sulfur dioxide 

(SO2) and nitrogen oxides (NOx) 

emissions. On July 11, 2008, the D.C. 

Circuit issued an opinion finding parts 

of the CAIR unlawful and vacating the 

rule. On December 23, the D.C. Circuit 

issued a decision on the petitions for 

rehearing of the July 11 decision. The 

court granted EPA’s petition for 

rehearing to the extent that it remanded 

the cases without vacatur of the CAIR. 

This ruling means that the CAIR 

remains in place temporarily but that 

EPA is obligated to promulgate another 

rule under Clean Air Act section 

110(a)(2)(D) consistent with the court’s 

July 11 opinion. This action would 

fulfill our obligation to develop a rule 

consistent with the July 11, 2008, and 

December 23, 2008, D.C. Court 

decisions. 

Statement of Need: 

The Clean Air Transport Rule is 

necessary to help States address 

interstate transport of pollutants from 

upwind States to downwind 

nonattainment areas. Specifically, the 

rule is needed to respond to the 

remand of the Clean Air Interstate Rule 

by the U.S. Court of Appeals for the 

D.C. Circuit. 

Summary of Legal Basis: 

The Clean Air Transport Rule is needed 

to help States address the requirements 

of section 110(a)(2)(D)(i) of the Clean 

Air Act. This section requires States to 

prohibit emissions that contribute 

significantly to downwind 

nonattainment with the national 

ambient air quality standards or which 

interfere with maintaining the 

standards in those downwind States. 

Alternatives: 

To be determined. 

Anticipated Cost and Benefits: 

The proposed rule would yield more 

than $120 to $290 billion in annual 

benefits in 2014. This far outweighs the 

estimated annual costs of $2.8 billion 

for that year. Both the annual benefits 

and costs are in 2006 dollars. The 

emission reductions from this proposed 

rule would lead to significant annual 

health benefits. In 2014, this rule 

would protect public health by 

avoiding: 14,000 to 36,000 premature 

deaths, 21,000 cases of acute bronchitis, 

23,000 nonfatal heart attacks, 26,000 

hospital and emergency room visits, 1.9 

million days when people miss work 

or school, 240,000 cases of aggravated 

asthma, and 440,000 upper and lower 

respiratory symptoms. Air quality 

improvements would lead to increased 

visibility in national and State parks, 

and increased protection for sensitive 

ecosystems including, Adirondack and 

Appalachian lakes, coastal waters and 

estuaries, and sugar maple forests. 

Risks: 

To be determined. 

Timetable: 

Action Date FR Cite 

NPRM 08/02/10 75 FR 45210 

NODA 09/01/10 75 FR 53613 

NPRM Correcting 

Amendments 

09/14/10 75 FR 55711 

NPRM Comment 

Period End 

10/01/10 

Final Action 07/00/11 

Regulatory Flexibility Analysis 

Required: 

No 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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Small Entities Affected: 

Businesses, Governmental Jurisdictions 

Government Levels Affected: 

Federal, Local, State 

Energy Effects: 

Statement of Energy Effects planned as 

required by Executive Order 13211. 

International Impacts: 

This regulatory action will be likely to 

have international trade and investment 

effects, or otherwise be of international 

interest. 

Additional Information: 

EPA publication information: NPRM - 

http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

0900006480b25be1; EPA Docket 

information: EPA-HQ-OAR-2009-0491 

Sectors Affected: 

221112 Fossil Fuel Electric Power 

Generation 

URL For More Information: 

www.epa.gov/airtransport 

Agency Contact: 

Gabrielle Stevens 

Environmental Protection Agency 

Air and Radiation 

6204J 

Washington, DC 20460 

Phone: 202 343–9252 

Fax: 202 343–2359 

Email: stevens.gabrielle@epamail.epa.gov 

Meg Victor 

Environmental Protection Agency 

Air and Radiation 

6204J 

Washington, DC 20460 

Phone: 202 343–9193 

Email: victor.meg@epamail.epa.gov 

RIN: 2060–AP50 

EPA 

151. REVISION TO PB AMBIENT AIR 

MONITORING REQUIREMENTS 

Priority: 

Other Significant 

Legal Authority: 

42 USC 7403, 7410, 7601(a), 7611, and 

7619 

CFR Citation: 

40 CFR 58 

Legal Deadline: 

None 

Abstract: 

On November 12, 2008, the 

Environmental Protection Agency (EPA) 

revised the National Ambient Air 

Quality Standards (NAAQS) for lead 

(Pb) and associated monitoring 

requirements. The finalized monitoring 

requirements require State and local 

monitoring agencies to conduct Pb 

monitoring near Pb sources emitting 1.0 

tons per year (tpy) or more and in large 

urban areas referred to as Core Based 

Statistical Areas (CBSA) with a 

population of 500,000 people or more. 

In January 2009, EPA received a 

petition from the Missouri Coalition for 

the Environment Foundation, Natural 

Resources Defense Council, the 

Coalition to End Childhood Poisoning, 

and Physicians for Social 

Responsibility requesting EPA 

reconsider the 1.0 tpy emission 

threshold. EPA granted the petition to 

reconsider on July 22, 2009. This action 

represents the results of the EPA’s 

reconsideration of the Pb monitoring 

requirements. 

A proposed revision was published on 

December 30, 2009, in which the EPA 

proposed to lower the emission 

threshold to 0.50 tpy, and to require 

Pb monitoring at the approximately 80 

NCore sites instead of monitoring Pb 

in CBSA’s with a population greater 

than 500,000. The EPA also requested 

comments on an emission threshold 

greater than 0.50 tpy, alternative 

approaches for monitoring Pb near 

airports, and on staggering the 

monitoring deployment over two years. 

Statement of Need: 

This action is in response to a petition 

to reconsider that the Agency received 

and granted on the Pb monitoring 

requirements contained in the revision 

to the Pb NAAQS (73 FR 66964). 

Summary of Legal Basis: 

Clean Air Act title I 

Alternatives: 

To be determined. 

Anticipated Cost and Benefits: 

To be determined. 

Risks: 

To be determined. 

Timetable: 

Action Date FR Cite 

NPRM 12/30/09 74 FR 69050 

NPRM Comment 

Period End 

02/16/10 

Final Action 01/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Federal, Local, State 

Additional Information: 

EPA publication information: NPRM - 

http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

0900006480a74184; EPA Docket 

information: EPA-HQ-OAR-2006-0735 

Sectors Affected: 

9241 Administration of Environmental 

Quality Programs 

URL For More Information: 

http://www.epa.gov/air/lead 

Agency Contact: 

Kevin Cavender 

Environmental Protection Agency 

Air and Radiation 

C304–06 

Research Triangle Park, NC 27711 

Phone: 919 541–2364 

Fax: 919 541–1903 

Email: cavender.kevin@epamail.epa.gov 

Lewis Weinstock 

Environmental Protection Agency 

Air and Radiation 

C304–06 

Research Triangle Park, NC 27711 

Phone: 919 541–3661 

Fax: 919 541–1903 

Email: weinstock.lewis@epamail.epa.gov 

RIN: 2060–AP77 

EPA 

152. RECONSIDERATION OF THE 2008 

OZONE PRIMARY AND SECONDARY 

NATIONAL AMBIENT AIR QUALITY 

STANDARDS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

42 USC 7409 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

On March 12, 2008, EPA announced 

the final decision on the ozone national 

ambient air quality standards (NAAQS). 

Soon after that decision was signed on 

March 27, 2008 (73 FR 16436), the 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79664 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Clean Air Scientific Advisory 

Committee (CASAC) held an 

unsolicited public meeting and 

criticized EPA for setting primary and 

secondary standards that were not 

consistent with advice provided by the 

CASAC during review of the NAAQS. 

On July 25, 2008, several 

environmental and industry petitioners, 

as well as a number of States, sued EPA 

on the NAAQS decision, and the Court 

set a briefing schedule for the 

consolidated cases on December 23, 

2008. On March 10, 2009, EPA 

requested that the Court vacate the 

briefing schedule and hold the 

consolidated cases in abeyance for 180 

days. This request for extension was 

made to allow time for appropriate EPA 

officials appointed by the new 

Administration to determine whether 

the standards established in March 

2008 should be maintained, modified, 

or otherwise reconsidered. 

Announcement of reconsideration of 

the March 2008 NAAQS decision 

occurred on September 16, 2009. The 

NAAQS proposal (including a proposal 

to stay implementation designations for 

the March 2008 NAAQS) was signed 

on January 6, 2010, with the final rule 

to be signed on or around October 

2010. Reconsideration of the NAAQS 

will be limited to information and 

supporting documentation available to 

EPA and in the docket at the time of 

the March 2008 decision. 

Statement of Need: 

As established in the Clean Air Act, 

the national ambient air quality 

standards for ozone are to be reviewed 

every 5 years. As outlined in the 

abstract of this regulatory plan entry, 

this reconsideration is in response to 

actions by the courts regarding the last 

review in 2008. 

Summary of Legal Basis: 

Section 109 of the Clean Air Act (42 

U.S.C. 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. 

Alternatives: 

The main alternatives for the 

Administrator’s decision are whether to 

set different primary and secondary 

ozone standards than those set in 2008. 

Anticipated Cost and Benefits: 

A supplement to the RIA was prepared 

that presents the costs and benefits 

associated with the proposed revised 

ozone standards. This RIA was made 

available when the Notice of Proposed 

Rulemaking was published. 

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 01/19/10 75 FR 2938 

NPRM Comment 

Period End 

03/22/10 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal, Local, State, Tribal 

Additional Information: 

EPA publication information: NPRM - 

http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

0900006480a7f618; Related to RIN 

2060-AN24; EPA Docket information: 

EPA-HQ-OAR-2005-0172 

URL For More Information: 

http://www.epa.gov/air/criteria.html 

Agency Contact: 

Susan Stone 

Environmental Protection Agency 

Air and Radiation 

C504–06 

Research Triangle Park, NC 27711 

Phone: 919 541–1146 

Fax: 919 541–0237 

Email: stone.susan@epa.gov 

Karen Martin 

Environmental Protection Agency 

Air and Radiation 

C504–06 

Research Triangle Park, NC 27711 

Phone: 919 541–5274 

Fax: 919 541–0237 

Email: martin.karen@epamail.epa.gov 

Related RIN: Related to 2060–AN24 

RIN: 2060–AP98 

EPA 

153. REVISIONS TO MOTOR VEHICLE 

FUEL ECONOMY LABEL 

Priority: 

Other Significant 

Unfunded Mandates: 

Undetermined 

Legal Authority: 

Clean Air Act 

CFR Citation: 

40 CFR 85, 86, 600; 49 CFR 575 

Legal Deadline: 

None 

Abstract: 

EPA is responsible for developing the 

fuel economy labels that are posted on 

window stickers of all new light duty 

cars and trucks sold in the U.S. and, 

beginning with the 2011 model year, 

on all new medium-duty passenger 

vehicles (a category that includes large 

sport-utility vehicles and passenger 

vans). In 2006, EPA updated how the 

city and highway fuel economy values 

are calculated, to better reflect typical 

real-world driving patterns and provide 

more realistic fuel economy estimates. 

Since then, increasing market 

penetration of advanced technology 

vehicles, in particular plug-in hybrid 

electric vehicles and electric vehicles, 

will require new metrics to effectively 

convey information to consumers. This 

action will amend the way in which 

fuel economy estimates are calculated 

and/or displayed. The changes in this 

action will not impact the Corporate 

Average Fuel Economy requirements. 


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Statement of Need: 

The Environmental Protection Agency 

(EPA) and the National Highway Traffic 

Safety Administration (NHTSA) have 

recently jointly proposed to redesign 

and add information to the current fuel 

economy label that is posted on the 

window sticker of all new cars and 

light-duty trucks sold in the U.S. The 

redesigned label will provide new 

information to American consumers 

about the fuel economy and 

consumption, fuel costs, and 

environmental impacts associated with 

purchasing new vehicles beginning 

with model year 2012 cars and trucks. 

This action will also develop new 

labels for certain advanced technology 

vehicles, which are poised to enter the 

U.S. market, in particular plug-in 

hybrid electric vehicles and electric 

vehicles. 

NHTSA and EPA are proposing these 

changes because the Energy 

Independence and Security Act (EISA) 

of 2007 imposes several new labeling 

requirements, because the labels for 

conventional vehicles can be improved 

to help consumers make more informed 

vehicle purchase decisions, and 

because the time is right to develop 

new labels for advanced technology 

vehicles that are being commercialized. 

Summary of Legal Basis: 

Both EPA and NHTSA have authority 

over labeling requirements related to 

fuel economy and environmental 

information under the Energy Policy 

and Conservation Act (EPCA) and the 

Energy Independence and Security Act 

(EISA), respectively. In order to 

implement that authority in the most 

coordinated and efficient way, the 

agencies have jointly proposed to revise 

the Fuel Economy label. 

Alternatives: 

The rulemaking proposal includes an 

alternative label that is being 

considered in addition to the Agency’s 

primary proposal. 

Anticipated Cost and Benefits: 

The primary costs associated with this 

proposed rule come from revisions to 

the fuel economy label and codifying 

testing requirements for EVs and 

PHEVs. This rule is not economically 

significant under E.O. 12866 or any 

DOT or EPA policies and procedures 

because it does not exceed $100 million 

or meet other related standards. The 

primary benefits associated with this 

proposed rule come from any 

improvements in consumer 

decisionmaking that may lead to 

reduced vehicle and fuel costs for 

them. There may be additional effects 

on criteria pollutants and greenhouse 

gas emissions. At this time, EPA and 

NHTSA do not believe it is feasible to 

fully develop a complete benefits 

analysis of the potential benefits. 

Risks: 

The failure to finalize updated 

conventional vehicle fuel economy 

labels and to create new labels for EVs 

and PHEVs will result in labels that 

are unhelpful and potentially 

misleading for consumers as they seek 

to select more energy efficient and 

environmentally friendly vehicles that 

meet their needs. 

Timetable: 

Action Date FR Cite 

NPRM 09/23/10 75 FR 58078 

Notice—Public 

Meeting 

09/28/10 75 FR 59673 

NPRM Comment 

Period End 

11/22/10 

Final Action 02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

Additional Information: 

EPA Docket information: EPA-HQ-OAR2009-0865 

URL For More Information: 

http://www.epa.gov/fueleconomy/ 

regulations.htm 

Agency Contact: 

Lucie Audette 

Environmental Protection Agency 

Air and Radiation 

NVFEL 

Ann Arbor, MI 48105 

Phone: 734 214–4850 

Email: audette.lucie@epamail.epa.gov 

Chelsea May 

Environmental Protection Agency 

Air and Radiation 

NVFEL 

Ann Arbor, MI 48105 

Phone: 734 214–4226 

Email: may.chelsea@epamail.epa.gov 

RIN: 2060–AQ09 

EPA 

154. NATIONAL EMISSION 

STANDARDS FOR HAZARDOUS AIR 

POLLUTANTS FOR MAJOR 

SOURCES: INDUSTRIAL, 

COMMERCIAL, AND INSTITUTIONAL 

BOILERS AND PROCESS HEATERS 

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: 

Clean Air Act sec 112 

CFR Citation: 

40 CFR 63 

Legal Deadline: 

NPRM, Judicial, April 29, 2010, 60–day 

extension granted on June 30, 2009. An 

additional 2 weeks was subsequently 

granted. Signature date: April 29, 2010. 

Final, Judicial, January 16, 2011, 

30–day extension granted from 

December 16, 2011. 

Abstract: 

Section 112 of the Clean Air Act (CAA) 

outlines the statutory requirements for 

EPA’s stationary source air toxics 

program. Section 112 mandates that 

EPA develop standards for hazardous 

air pollutants (HAP) for both major and 

area sources listed under section 112(c). 

This regulatory action will finalize 

emission standards for boilers and 

process heaters located at major 

sources. Section 112(d)(2) requires that 

emission standards for major sources be 

based on the maximum achievable 

control technology (MACT). Industrial 

boilers and institutional/commercial 

boilers are on the list of section 

112(c)(6) source categories. In this 

rulemaking, EPA will finalize standards 

for these source categories. 

Statement of Need: 

As a result of the vacatur of the 

Industrial Boiler MACT, the Agency 

will develop another rulemaking under 

CAA section 112 which will reduce 

hazardous air pollutant (HAP) 

emissions from this source category. 

Recent court decisions on other CAA 

section 112 rules will be considered in 

developing this regulation. 

Summary of Legal Basis: 

Clean Air Act, section 112. 


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Alternatives: 

Not yet determined. 

Anticipated Cost and Benefits: 

EPA estimates the total national capital 

cost for the final rule to be 

approximately $9.5 billion in the year 

2013, with a total national annual cost 

of $2.9 billion in the year 2013. The 

annual cost, which considers fuel 

savings, includes control device 

operation and maintenance as well as 

monitoring, recordkeeping, reporting, 

and performance testing. EPA estimates 

that implementation of the rulemaking, 

as proposed, would reduce nationwide 

emissions from major source boilers 

and process heaters by: 15,000 pounds 

per year of mercury, 3,200 tpy of nonmercury metals, 37,000 tpy of HCl, 

50,000 tpy of PM, 340,000 tpy of SO2, 

722 grams per year of dioxin and 1,800 

tpy of volatile organic compounds. 

These emissions reductions would lead 

to the following annual health benefits. 

In 2013, this rule will protect public 

health by avoiding 1,900 to 4,800 

premature deaths, 1,300 cases of 

chronic bronchitis, 3,000 nonfatal heart 

attacks, 3,200 hospital and emergency 

room visits, 3,000 cases of acute 

bronchitis, 250,000 days when people 

miss work, 33,000 cases of aggravated 

asthma, and 1,500,000 acute respiratory 

symptoms. The monetized value of the 

benefits ranges from $17 billion to $41 

billion in 2013—outweighing the costs 

by at least $14 billion. 

Risks: 

Not yet determined. 

Timetable: 

Action Date FR Cite 

NPRM 06/04/10 75 FR 32006 

NPRM Extension of 

Comment Period 

06/09/10 75 FR 32682 

NPRM Comment 

Period End 

07/19/10 

NPRM Comment 

Period Extended To 

08/03/10 

Final Action 06/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions, 

Organizations 

Government Levels Affected: 

Federal, Local, State, Tribal 

Federalism: 

This action may have federalism 

implications as defined in EO 13132. 

Additional Information: 

EPA publication information: NPRM - 

http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

0900006480afbb49; Split from RIN 

2060-AM44. This rulemaking combines 

the area source rulemaking for boilers 

and the rulemaking for re-establishing 

the vacated NESHAP for boilers and 

process heaters.; EPA Docket 

information: EPA-HQ-OAR-2002-0058 

Sectors Affected: 

325 Chemical Manufacturing; 611 

Educational Services; 322 Paper 

Manufacturing; 221 Utilities; 321 Wood 

Product Manufacturing 

Agency Contact: 

Brian Shrager 

Environmental Protection Agency 

Air and Radiation 

C439–01 

Research Triangle Park, NC 27711 

Phone: 919 541–7689 

Email: shrager.brian@epa.gov 

Robert J Wayland 

Environmental Protection Agency 

Air and Radiation 

C439–01 

Research Triangle Park, NC 27711 

Phone: 919 541–1045 

Email: wayland.robertj@epamail.epa.gov 

Related RIN: Related to 2060–AM44 

RIN: 2060–AQ25 

EPA 

155. LEAD; CLEARANCE AND 

CLEARANCE TESTING 

REQUIREMENTS FOR THE 

RENOVATION, REPAIR, AND 

PAINTING PROGRAM 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Unfunded Mandates: 

This action may affect the private 

sector under PL 104-4. 

Legal Authority: 

15 USC 2601(c); 15 USC 2682(c)(3); 15 

USC 2684; 15 USC 2686; 15 USC 2687 

CFR Citation: 

40 CFR 745 

Legal Deadline: 

NPRM, Judicial, April 22, 2010, 

Signature. 

Final, Judicial, July 15, 2011, Signature. 

Abstract: 

On May 6, 2010, EPA proposed several 

revisions to the 2008 Lead Renovation, 

Repair, and Painting Program (RRP) 

rule that established accreditation, 

training, certification, and 

recordkeeping requirements, as well as 

work practice standards for persons 

performing renovations for 

compensation in most pre-1978 housing 

and child-occupied facilities. Current 

requirements include training 

renovators, other renovation workers, 

and dust sampling technicians; for 

certifying renovators, dust sampling 

technicians, and renovation firms; for 

accrediting providers of renovation and 

dust sampling technician training; for 

renovation work practices; and for 

recordkeeping. EPA is particularly 

concerned about dust lead hazards 

generated by renovations because of the 

well documented toxicity of lead, 

especially to younger children. This 

proposal includes additional 

requirements designed to ensure that 

lead-based paint hazards generated by 

renovation work are adequately cleaned 

after renovation work is finished and 

before the work areas are re-occupied. 

Specifically, EPA proposed to require 

dust wipe testing after many 

renovations covered by the RRP rule. 

For a subset of jobs involving 

demolition or removal of plaster 

through destructive means or the 

disturbance of paint using machines 

designed to remove paint through highspeed operation, such as power sanders 

or abrasive blasters, this proposal 

would also require the renovation firm 

to demonstrate, through dust wipe 

testing, that dust-lead levels remaining 

in the work area are below regulatory 

levels. 

Statement of Need: 

EPA is particularly concerned about 

dust lead hazards generated by 

renovations because children, 

especially younger children, are at risk 

for high exposures of lead-based paint 

dust via hand-to-mouth exposure. This 

rulemaking revision is being considered 

in response to a settlement agreement. 

Summary of Legal Basis: 

Section 402(c)(3) of the Toxic 

Substances Control Act (TSCA) requires 

EPA to regulate renovation or 

remodeling activities that create leadbased paint hazards in target housing, 

which is defined by statute to cover 

most pre-1978 housing, public 

buildings built before 1978, and 

commercial buildings. The work 

practice requirements for dust wipe 

testing and clearance, training, 

certification and accreditation 

requirements, and State, territorial, and 

tribal authorization provisions are being 


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promulgated under the authority of 

TSCA sections 402(c)(3), 404, and 407 

(15 U.S.C. 2682(c)(3), 2684, and 2687). 

Alternatives: 

In addition to the proposed rule option, 

the Economic Analysis for the proposed 

rule analyzes several alternative 

options, including options with lower 

and higher thresholds (in terms of the 

amount of lead-based paint disturbed) 

for renovations that require dust wipe 

testing or clearance. See also the 

discussion in the preamble to the 

proposed rule at page 25058 et seq. 

Anticipated Cost and Benefits: 

Benefits. The proposed rule is 

estimated to generate benefits by 

providing greater assurance that dustlead hazards created by renovations are 

adequately cleaned up, primarily by 

requiring renovation firms to provide 

building owners and occupants with 

information on dust lead levels 

remaining in the work area after many 

renovation projects, but also by 

requiring renovation firms to 

demonstrate that they have achieved 

regulatory clearance levels after some 

of the dustiest renovations. These 

changes will protect individuals 

residing in target housing or attending 

a child-occupied facility where these 

renovation events are performed. It will 

also protect individuals who move into 

target housing after such a renovation 

is performed, or who visit a friend, 

relative, or caregiver’s house where 

such a renovation is performed. EPA 

has estimated the number of 

individuals residing in target housing 

units or attending COFs where 

renovation events are performed. The 

proposed rule will benefit 809,000 

children under the age of 6 and 

7,547,000 individuals age 6 and older 

(including 96,000 pregnant women) per 

year by minimizing their exposure to 

lead dust generated by renovations. The 

low threshold option would protect 

882,000 children under the age of 6 and 

8,193,000 individuals age 6 and older, 

including 105,000 pregnant women. 

The high threshold option protects 

706,000 children and 6,590,000 

individuals age 6 and older, including 

83,000 pregnant women. The remaining 

three alternative options (dust wipe 

testing only, clearance only, and third 

party dust wipe testing) would affect 

the same number of individuals as the 

proposed rule, although the amount of 

protection provided to some of those 

individuals may differ from the 

proposed rule. 

Costs. Total annualized costs for the 

proposed rule are $272 million per year 

using a 3 percent discount rate and 

$293 million per year using a 7 percent 

discount rate. Under the low threshold 

option, costs are $312 million per year 

with a 3 percent discount rate and $336 

million per year with a 7 percent rate. 

Under the high threshold option, costs 

are $224 million per year with a 3 

percent discount rate and $242 million 

per year with a 7 percent discount rate. 

The option that only requires dust wipe 

testing costs $268 million per year with 

a 3 percent discount rate and $288 

million per year with a 7 percent 

discount rate. The option requiring 

clearance for all renovations covered by 

the proposed rule costs $367 million 

with a 3 percent discount rate and $394 

million with a 7 percent discount rate. 

The option requiring the use of a thirdparty for dust wipe sampling costs $431 

million per year with a 3 percent 

discount rate and $459 million per year 

with a 7 percent discount rate. These 

cost estimates are based on the 

assumption that improved lead test kits 

would be available. 

Risks: 

Lead is known for its ‘‘broad array of 

deleterious effects on multiple organ 

systems via widely diverse mechanisms 

of action.’’ (EPA Air Quality Criteria for 

Lead, October 2006). This array of 

health effects includes heme 

biosynthesis and related functions; 

neurological development and function; 

reproduction and physical 

development; kidney function; 

cardiovascular function; and immune 

function. There is also some evidence 

of lead carcinogenicity, primarily from 

animal studies, together with limited 

human evidence of suggestive 

associations. Of particular interest to 

EPA during the RRP rulemaking was 

the delineation of lowest observed 

effect levels for those lead-induced 

effects that are most clearly associated 

with blood lead levels of less than 10 

micrograms per deciliter in children 

and adults. See also the discussion in 

the preamble to the proposed rule at 

page 25039 et seq. 

Timetable: 

Action Date FR Cite 

NPRM 05/06/10 75 FR 25038 

NPRM Comment 

Period End 

07/06/10 

NPRM Extension of 

Comment Period 

07/07/10 75 FR 38959 

NPRM Comment 

Period Extended To 

08/06/10 

Final Action 07/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Federal, Local, State, Tribal 

Additional Information: 

EPA publication information: NPRM - 

http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

0900006480ae7efa; EPA Docket 

information: EPA-HQ-OPPT-2005-0049 

URL For More Information: 

http://www.epa.gov/lead/pubs/ 

renovation.htm 

Agency Contact: 

Cindy Wheeler 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7404T 

Washington, DC 20460 

Phone: 202 566–0484 

Email: wheeler.cindy@epa.gov 

Michelle Price 

Environmental Protection Agency 

Office of Chemical Safety and Pollution 

Prevention 

7404T 

Washington, DC 20460 

Phone: 202 566–0744 

Email: price.michelle@epa.gov 

RIN: 2070–AJ57 

EPA 

156. IDENTIFICATION OF 

NON–HAZARDOUS SECONDARY 

MATERIALS THAT ARE SOLID 

WASTES 

Priority: 

Other Significant 

Legal Authority: 

42 USC 6903(27); 42 USC 6912(a)(1) 

CFR Citation: 

40 CFR 241 

Legal Deadline: 

NPRM, Judicial, April 29, 2010. 

Final, Judicial, January 16, 2011. 

Abstract: 

The Agency has proposed to define 

which non-hazardous secondary 

materials burned in combustion units 

are solid wastes under the Resource 

Conservation and Recovery Act (RCRA). 


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This in turn will assist the Agency in 

determining which non-hazardous 

secondary materials will be subject to 

the emissions standards proposed 

under sections 112 and 129 of the 

Clean Air Act (CAA). If the secondary 

material is considered a ‘‘solid waste,’’ 

the unit that burns the non-hazardous 

secondary material would be subject to 

the CAA section 129 requirements. The 

meaning of ‘‘solid waste’’ as defined 

under RCRA is important because CAA 

section 129, which regulates emissions 

from sources that combust solid wastes, 

states that the term ‘‘solid waste’’ shall 

have the meaning ‘‘established by the 

Administrator [pursuant to RCRA].’’ 

Statement of Need: 

EPA is preparing to establish new 

emission standards under CAA sections 

112 and 129. In order to establish these 

new emission standards, EPA must 

determine at the federal level which 

non-hazardous secondary materials are 

considered ‘‘solid waste.’’ The meaning 

of solid waste for purposes of these 

CAA standards is of particular 

importance since CAA section 129 

states that the term ‘‘solid waste’’ shall 

have the meaning ‘‘established by the 

Administrator.’’ 

Summary of Legal Basis: 

EPA is promulgating this regulation 

under the authority of sections 

2002(a)(1) and 1004(27) of RCRA, as 

amended, 42 U.S.C. 6912(a)(1) and 

6903(27). Section 129(a)(1(D) of the 

CAA directs EPA to establish standards 

for Commercial and Industrial Solid 

Waste Incinerators (CISWI), which burn 

solid waste (CAA sec. 129(g)(6), 42 

U.S.C. 7429). Section 129(g)(6) provides 

that the term, solid waste, is to be 

established by EPA under RCRA. 

Section 2002(a)(1) of RCRA authorizes 

the Agency to promulgate regulations 

as are necessary to carry out the 

functions under the Act. The statutory 

definition of ‘‘solid waste’’ is provided 

in RCRA section 1004(27). 

Alternatives: 

The Notice of Proposed Rulemaking 

(NPRM) proposes an ‘‘Alternative 

Approach’’ that is broader than the 

proposed solid waste definition. This 

alternative may be adopted in the final 

rule, if warranted by information 

presented during the public comment 

period or otherwise available in the 

rulemaking record. Under this 

alternative, most non-hazardous 

secondary materials that are burned in 

a combustion unit would be considered 

solid wastes. Only fuels or ingredients 

that are combusted and remain within 

the control of the generator and met 

the legitimacy criteria would not be 

solid wastes under this alternative. This 

approach would not allow discarded 

materials processed into new product 

fuels to be considered as non-wastes, 

or allow for a petition process. This 

approach would expand the universe of 

non-hazardous secondary materials that 

would be considered to be solid wastes, 

and thus subject to CAA section 129. 

The proposed rule also takes comment 

on an approach that would classify all 

non-hazardous secondary materials that 

are burned in combustion units as solid 

wastes. 

Anticipated Cost and Benefits: 

The proposed rule specifies criteria 

under which non-hazardous secondary 

materials are considered solid wastes. 

Although the final rule will determine 

which section of the CAA under which 

a given combustion unit is regulated, 

this rule itself will not include any 

emission standards and will not require 

changes in the management or use of 

secondary materials. Only with the 

promulgation of the respective rules 

developed within EPA’s Office of Air 

and Radiation (OAR) would society 

realize the costs, benefits, and other 

impacts. These impacts, therefore, are 

attributed entirely to the rules being 

developed by OAR. 

Risks: 

Air emission risks will be reduced as 

a result of the current promulgation of 

three-related rules developed by OAR 

and this rule. However, material 

diversion risks may increase under 

certain limited scenarios. 

Timetable: 

Action Date FR Cite 

ANPRM 01/02/09 74 FR 41 

ANPRM Comment 

Period End 

02/02/09 

NPRM 06/04/10 75 FR 31843 

NPRM Extension of 

Comment Period 

06/09/10 75 FR 32682 

NPRM Comment 

Period End 

07/19/10 

Action Date FR Cite 

NPRM Comment 

Period Extended To 

08/03/10 

Final Action 01/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal, Local, State, Tribal 

Additional Information: 

EPA publication information: ANPRM 

- http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

090000648080b3d3; NPRM - 

http://www.regulations.gov/search/ 

Regs/home.html#documentDetail?R= 

0900006480afbb78, NPRM - Extension 

of Comment Period - 

http://www.regulations.gov/search/ 

Regs/home.html#documentDetail? For 

information on the proposed CAA 

emissions standards for boilers, process 

heaters, and commercial/industrial 

solid waste incinerators, see 

http://www.epa.gov/airquality/ 

combustion/; EPA Docket information: 

EPA-HQ-RCRA-2008-0329 

URL For More Information: 

http://www.epa.gov/epawaste/nonhaz/ 

define/index.htm 

Agency Contact: 

Marc Thomas 

Environmental Protection Agency 

Solid Waste and Emergency Response 

5303P 

Washington, DC 20460 

Phone: 703 308–0023 

Fax: 703 308–0509 

Email: thomas.marc@epa.gov 

George Faison 

Environmental Protection Agency 

Solid Waste and Emergency Response 

5303P 

Washington, DC 20460 

Phone: 703 305–7652 

Fax: 703 308–0509 

Email: faison.george@epa.gov 

RIN: 2050–AG44 

BILLING CODE 6560–50–S 


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EQUAL EMPLOYMENT OPPORTUNITY 

COMMISSION (EEOC) 

Statement of Regulatory Priorities 

The mission of the Equal Employment 

Opportunity Commission (EEOC, 

Commission, or agency) is to ensure 

equality of opportunity in employment 

by vigorously enforcing seven 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 (makes it illegal to 

pay unequal wages to men and women 

performing substantially equal work at 

the same establishment, unless the 

difference is attributable to a bona fide 

seniority, merit, or incentive system, or 

to a factor other than sex); the Age 

Discrimination in Employment Act of 

1967 (ADEA) as amended (prohibits 

employment discrimination based on 

age of 40 or older); Titles I and V of the 

Americans with Disabilities Act, as 

amended, and sections 501 and 505 of 

the Rehabilitation Act, as amended 

(prohibit employment discrimination 

based on disability); Title II of the 

Genetic Information Nondiscrimination 

Act (GINA) (prohibits employment 

discrimination based on genetic 

information and limits acquisition and 

disclosure of genetic information); and 

section 304 of the Government 

Employee Rights Act of 1991 (protects 

certain previously exempt state & local 

government employees from 

employment discrimination on the basis 

of race, color, religion, sex, national 

origin, age, or disability). 

The first item in this regulatory plan 

is entitled ‘‘Genetic Information 

Nondiscrimination Act.’’ GINA was 

signed into law on May 21, 2008. 

Congress enacted GINA in recognition 

of many achievements in the field of 

genetics, the decoding of the human 

genome, and the creation and increased 

use of genomic medicine. Many genetic 

tests now exist that can inform 

individuals whether they may be at risk 

for developing a specific disease or 

disorder. GINA was enacted to address 

public concerns regarding the potential 

for misuse of genetic information. 

Title II of GINA protects job 

applicants, current and former 

employees, labor union members, and 

apprentices and trainees from 

discrimination based on their genetic 

information. GINA prohibits use of 

genetic information in employment, 

whether acquired through genetic 

testing or from an individual’s family 

medical history, and limits acquisition 

and disclosure of such information. It 

requires that, when genetic information 

is acquired, it be maintained in a 

confidential medical file, separate and 

apart from personnel information. 

The second item in this regulatory 

plan is entitled ‘‘Regulations To 

Implement the Equal Employment 

Provisions of the Americans With 

Disabilities Act Amendments Act.’’ The 

Americans with Disabilities Act 

Amendments Act of 2008 (‘‘the 

Amendments Act’’ or ‘‘the Act’’) was 

signed into law on September 25, 2008, 

with a statutory effective date of January 

1, 2009. The Act makes important 

changes to the definition of the term 

‘‘disability’’ by rejecting the holdings in 

several Supreme Court decisions and 

portions of EEOC’s ADA regulations. 

The Act retains the ADA’s basic 

definition of ‘‘disability’’ as an 

impairment that substantially limits one 

or more major life activities, a record of 

such an impairment, or being regarded 

as having such an impairment. 

However, it changes the way that these 

statutory terms should be interpreted in 

several ways. The effect of these 

changes is to make it easier for an 

individual seeking protection under the 

ADA to establish that he or she has a 

disability within the meaning of the 

ADA. 

Consistent with section 4(c) of 

Executive Order 12866, this statement 

was reviewed and approved by the 

Chair of the Agency. The statement has 

not been reviewed or approved by the 

other members of the Commission. 

EEOC 

FINAL RULE STAGE 

157. REGULATIONS TO IMPLEMENT 

THE EQUAL EMPLOYMENT 

PROVISIONS OF THE AMERICANS 

WITH DISABILITIES ACT 

AMENDMENTS ACT 

Priority: 

Other Significant 

Legal Authority: 

42 USC sec 12116 and sec 506 as 

redesignated under the ADA 

Amendments Act of 2008 

CFR Citation: 

29 CFR 1630 

Legal Deadline: 

None 

Abstract: 

The Americans With Disabilities Act 

Amendments Act of 2008 (‘‘the 

Amendments Act’’) was signed into law 

on September 25, 2008, with a statutory 

effective date of January 1, 2009. EEOC 

proposes to revise its Americans With 

Disabilities Act (ADA) regulations and 

accompanying interpretative guidance 

(29 CFR part 1630 and accompanying 

appendix) in order to implement the 

ADA Amendments Act of 2008. 

Pursuant to the 2008 amendments, the 

definition of disability under the ADA 

shall be construed in favor of broad 

coverage to the maximum extent 

permitted by the terms of the ADA, and 

the determination of whether an 

individual has a disability should not 

demand extensive analysis. The 

Amendments Act rejects the holdings 

in several Supreme Court decisions and 

portions of EEOC’s ADA regulations. 

The effect of these changes is to make 

it easier for an individual seeking 

protection under the ADA to establish 

that he or she has a disability within 

the meaning of the ADA. 

Statement of Need: 

This regulation is necessary to bring the 

Commission’s regulations into 

compliance with the ADA Amendments 

Act of 2008, which became effective 

January 1, 2009, and explicitly 

invalidated certain provisions of the 

existing regulations. The Amendments 

Act retains the terminology of the 

ADA’s basic definition of ‘‘disability’’ 

as an impairment that substantially 

limits one or more major life activities, 

a record of such an impairment, or 

being regarded as having such an 

impairment. However, it changes the 

way that these statutory terms should 

be interpreted in several ways, 

therefore necessitating revision of the 

existing regulations and interpretive 

guidance contained in the 

accompanying ‘‘Appendix to Part 

1630—Interpretive Guidance on Title I 

of the Americans With Disabilities 

Act,’’ which are published at 29 CFR 

part 1630. The proposed revisions to 

the title I regulations and appendix are 

intended to enhance predictability and 

consistency between judicial 

interpretations and executive 

enforcement of the ADA as now 

amended by Congress. 

Summary of Legal Basis: 

Section 506 of the Amendments Act, 

42 U.S.C. section 12205a, gives the 

EEOC the authority to issue regulations 

implementing the definitions of 

disability in section 12102 of this title 

(including rules of construction) and 


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the definitions in section 12103 of this 

title, consistent with the ADA 

Amendments Act of 2008. 

Alternatives: 

None: Congress mandated issuance of 

regulations. 

Anticipated Cost and Benefits: 

The EEOC anticipates economic and 

other benefits from the rule in many 

areas. For example, applicants and 

employees will be entitled to 

reasonable accommodation absent 

undue hardship to perform jobs for 

which they are qualified, whereas they 

may have been deemed not to meet the 

ADA’s definition of disability prior to 

the Amendments Act and denied 

accommodations as a result. Also, 

employers will incur benefits from their 

ability to retain, hire, and promote 

qualified personnel; increased 

employee attendance and productivity; 

avoidance of costs associated with 

under-performance, workplace injury, 

and turnover; and benefits from savings 

in workers’ compensation and related 

insurance. Finally, definitional clarity 

brought by the amended regulation will 

have the economic benefit of reducing 

litigation and the need for costly 

experts to address ‘‘disability,’’ and will 

streamline the issues requiring judicial 

attention. To the extent that employers 

may in some cases need to revise 

internal policies and procedures to 

reflect the broader definition of 

disability under the Amendments Act 

and train personnel to ensure 

appropriate compliance with the 

revised regulation, the Commission will 

continue to provide free technical 

assistance and outreach, including 

presentations and materials targeted 

specifically to small employers. 

Costs would be incurred by employers 

with 15 or more employees that are 

covered by the ADA. Applying the 

broader Amendments Act interpretation 

of when an impairment ‘‘substantially 

limits’’ a major life activity, more 

applicants and employees will meet the 

definition of disability and thus be 

potentially entitled to reasonable 

accommodations that do not pose an 

undue hardship. Available cost data is 

limited. However, using research 

indicating that the average cost of an 

accommodation is $462, the NPRM 

estimated the additional cost of 

accommodations as a result of the 

Amendments Act and the EEOC 

regulations at $74 million. Assuming 

these requests occur over 5 years, since 

it is reasonable to assume that not all 

new requests will occur in the same 

year, the annual estimated cost would 

be $15 million. The NPRM noted that 

it is possible that these estimates are 

at least twice as great as the actual costs 

would be, given research indicating 

that prior to the Amendments Act, 

fewer than half of the accommodation 

requests were granted. It is also 

important to note that both 

government-sponsored and private 

studies have repeatedly found that 

more than 50 percent of 

accommodations have zero costs for 

employers, both large and small. 

Risks: 

The proposed rule imposes no new or 

additional risk to employers. The 

proposal does not address risks to 

public health, safety, or the 

environment. 

Timetable: 

Action Date FR Cite 

NPRM 09/23/09 74 FR 48431 

Action Date FR Cite 

NPRM Comment 

Period End 

11/23/09 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

Businesses, Governmental Jurisdictions, 

Organizations 

Government Levels Affected: 

Federal, Local, State, Tribal 

Additional Information: 

The EEOC plans to issue a final rule 

by the end of December, 2010, subject 

to expedited E.O. 12866 review by 

OMB/OIRA. 

Agency Contact: 

Christopher Kuczynski 

Assistant Legal Counsel, Office of Legal 

Counsel 

Equal Employment Opportunity 

Commission 

131 M Street NE 

Washington, DC 20507 

Phone: 202 663–4665 

TDD Phone: 202 663–7026 

Fax: 202 663–4639 

Email: christopher.kuczynski@eeoc.gov 

Jeanne Goldberg 

Senior Attorney Advisor 

Equal Employment Opportunity 

Commission 

131 M Street NE 

Washinigton, DC 20507 

Phone: 202 663–4693 

Fax: 202 663–4639 

Email: jeanne.goldberg@eeoc.gov 

RIN: 3046–AA85 

BILLING CODE 6570–01–S 


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FINANCIAL STABILITY OVERSIGHT 

COUNCIL (FSOC) 

Statement of Regulatory Priorities 

Title I, subtitle A, of the Dodd-Frank 

Wall Street Reform and Consumer 

Protection Act (‘‘Dodd-Frank’’ or ‘‘Act’’) 

established the Financial Stability 

Oversight Council (FSOC). The purpose 

of the FSOC is to identify risks to the 

financial stability of the United States 

that could arise from the material 

financial distress or failure, or ongoing 

activities, of large, interconnected bank 

holding companies or nonbank financial 

companies. In addition, the Council is 

responsible for promoting market 

discipline and responding to emerging 

risks to the stability of the United States 

financial system. The duties of the 

FSOC are set forth in section 112(a)(2) 

of the Dodd-Frank Act. The FSOC 

consists of ten voting members and five 

non-voting members, who serve in an 

advisory capacity. The Secretary of the 

Treasury serves as Chairperson. 

Dodd-Frank provides the FSOC with 

authority to issue certain regulations to 

carry out the business of the Council 

and for certain other purposes. In fiscal 

year 2011, the FSOC has issued an 

advance notice of proposed rulemaking 

(ANPRM) regarding authority to require 

supervision and regulation of certain 

nonbank financial companies. This 

ANPRM is an initial step in the process 

by which the Council intends to 

develop a robust and disciplined 

framework for the designation of 

nonbank financial companies for 

heightened supervision. 

Over the next several months, the 

FSOC and its members will continue 

efforts to issue regulations, policies, and 

guidance mandated by the Act and to 

take other actions necessary to 

effectively carry out the Act. 

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GENERAL SERVICES 

ADMINISTRATION (GSA) 

I. Mission and Overview 

GSA oversees the business of the 

Federal Government. GSA’s acquisition 

solutions supplies Federal purchasers 

with cost-effective, high-quality 

products and services from commercial 

vendors. GSA provides workplaces for 

Federal employees and oversees the 

preservation of historic Federal 

properties. GSA helps keep the Nation 

safe by providing tools, equipment, and 

non-tactical vehicles to the U.S. 

military, and providing State and local 

governments with law enforcement 

equipment, firefighting and rescue 

equipment, and disaster recovery 

products and services. 

GSA serves the public by delivering 

services directly to its Federal 

customers through the Federal 

Acquisition Service (FAS), the Public 

Buildings Service (PBS), and the Office 

of Governmentwide Policy (OGP). GSA 

has a continuing commitment to its 

Federal customers and the U.S. 

taxpayers by providing those services in 

the most cost-effective manner possible. 

Federal Acquisition Service (FAS) 

FAS is the lead organization for 

procurement of products and services 

(other than real property) for the Federal 

Government. The FAS leverages the 

buying power of the Government by 

consolidating Federal agencies 

requirements for common goods and 

services. FAS provides a range of highquality and flexible acquisition services 

that increase overall Government 

effectiveness and efficiency. FAS 

business operations are organized into 

four business portfolios based on the 

product or service provided to customer 

agencies: Integrated Technology 

Services (ITS); Assisted Acquisition 

Services (AAS); General Supplies and 

Services (GSS); and Travel, Motor 

Vehicles, and Card Services (TMVCS). 

The FAS portfolio structure enables 

GSA and FAS to provide best value 

services, products, and solutions to its 

customers by aligning resources around 

key functions. 

Public Buildings Service (PBS) 

PBS is the largest public real estate 

organization in the United States, 

providing facilities and workspace 

solutions to more than 60 Federal 

agencies. PBS aims to provide a superior 

workplace for the Federal worker and 

superior value for the U.S. taxpayer. 

Balancing these two objectives is PBS’s 

greatest management challenge. PBS’s 

activities fall into two broad areas. The 

first is space acquisition through both 

leases and construction. PBS translates 

general needs into specific 

requirements, marshals the necessary 

resources, and delivers the space 

necessary to meet the respective 

missions of its Federal clients. The 

second area is management of space. 

This involves making decisions on 

maintenance, servicing tenants, and 

ultimately, deciding when and how to 

dispose of a property at the end of its 

useful life. 

Office of Governmentwide Policy (OGP) 

OGP sets Governmentwide policy in 

the areas of personal and real property, 

travel and transportation, information 

technology, regulatory information and 

use of Federal advisory committees. 

OGP also helps direct how all Federal 

supplies and services are acquired, as 

well as GSA’s own acquisition 

programs. OGP’s regulatory function 

fully incorporates the provisions of the 

President’s priorities and objectives 

under Executive Order 12866 with 

policies covering acquisition, travel, and 

property and management practices to 

promote efficient Government 

operations. OGP’s strategic direction is 

to ensure that Governmentwide policies 

encourage agencies to develop and 

utilize the best, most cost effective 

management practices for the conduct of 

their specific programs. To reach the 

goal of improving Governmentwide 

management of property, technology, 

and administrative services, OGP builds 

and maintains a policy framework, by 

(1) incorporating the requirements of 

Federal laws, Executive orders, and 

other regulatory material into policies 

and guidelines, (2) facilitating 

Governmentwide reform to provide 

Federal managers with business-like 

incentives and tools, and flexibility to 

prudently manage their assets, and (3) 

identifying, evaluating, and promoting 

best practices to improve efficiency of 

management processes. OGP’s policy 

regulations are described in the 

following subsections. 

Travel and Relocation Policy (FTR) 

Federal Travel Regulation (FTR) 

enumerates the travel and relocation 

policy for all title 5 Executive agency 

employees. The Code of Federal 

Regulations (CFR) is available at 

www.gpoaccess.gov/cfr. Each version is 

updated as official changes are 

published in the Federal Register (FR). 

FR publications and FTR looseleaf pages 

are available at www.gsa.gov/ftr. 

The FTR is the regulation contained 

in 41 Code of Federal Regulations (CFR), 

chapters 300 through 304, that 

implements statutory requirements and 

Executive branch policies for travel by 

Federal civilian employees and others 

authorized to travel at Government 

expense. 

The Administrator of General Services 

promulgates the FTR to: (a) Interpret 

statutory and other policy requirements 

in a manner that balances the need to 

ensure that official travel is conducted 

in a responsible manner with the need 

to minimize administrative costs and (b) 

communicate the resulting policies in a 

clear manner to Federal agencies and 

employees. 

Property and Management Policy (FMR) 

Federal Management Regulation 

(FMR) establishes policy for aircraft, 

transportation, personal property, and 

mail management. The FMR is the 

successor regulation to the Federal 

Property Management Regulation 

(FPMR). It contains updated regulatory 

policies originally found in the FPMR. 

However, it does not contain FPMR 

material that describes how to do 

business with the GSA. 

Acquisition Policy (FAR and GSAR) 

GSA helps provide to the public and 

the Federal buying community the 

updating and maintaining of the rule 

book for all Federal agency 

procurements, the Federal Acquisition 

Regulation (FAR). This is achieved 

through its extensive involvement with 

the Federal Acquisition Regulatory 

(FAR) Council. The FAR Council is 

comprised of senior representation from 

the Office of Federal Procurement 

Policy (OFPP), National Aeronautics 

and Space Administration (NASA), the 

Department of Defense (DoD), and GSA. 

The FAR Council directs the writing 

of the FAR cases, which is 

accomplished, in part, by teams of 

expert FAR analysts. All changes to the 

FAR are accompanied by review and 

analysis of public comment. Public 

comments play an important role in 

clarifying and enhancing this 

rulemaking process. The regulatory 

agenda pertaining to changes to the FAR 

are outside the scope of this discussion 

as GSA cannot speak on behalf of the 

FAR Council. 

GSA’s internal rules and practices on 

how it buys goods and services from its 

business partners are covered by the 

General Services Administration 

Acquisition Manual (GSAM) and the 

General Services Administration 

Acquisition Regulation (GSAR). The 


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GSAM is closely related to the FAR as 

it supplements areas of the FAR where 

GSA has additional and unique 

regulatory requirements. OCAO’s Office 

of Acquisition Policy writes and revises 

the GSAM and the GSAR. The size and 

scope of the FAR are substantially larger 

than the GSAR. In effect, the GSAR and 

the GSAM adds to the FAR by providing 

additional guidance to GSA officials and 

its business partners. 

Federal Acquisition Regulation (FAR): 

The FAR was established to codify 

uniform policies for acquisition of 

supplies and services by Executive 

agencies. It is issued and maintained 

jointly, pursuant to the Office of Federal 

Procurement Policy (OFPP) 

Reauthorization Act, under the statutory 

authorities granted to the Secretary of 

Defense, Administrator of General 

Services, and the Administrator, 

National Aeronautics and Space 

Administration. Statutory authorities to 

issue and revise the FAR have been 

delegated to the Procurement Executives 

in Department of Defense (DoD), GSA 

and National Aeronautics and Space 

Administration (NASA). 

GSA Acquisition Regulation Manual 

(GSAM) along with Acquisition Letters: 

The GSAM incorporates the GSAR as 

well as internal agency acquisition 

policy. The rules that require 

publication fall into two major 

categories: 

• Those that affect GSA’s business 

partners (e.g., prospective offerors and 

contractors). 

• Those that apply to acquisition of 

leasehold interests in real property. 

The FAR does not apply to leasing 

actions. GSA establishes regulations 

for lease of real property under the 

authority of 40 U.S.C. 490 note. 

GSA Acquisition Regulation (GSAR): 

The GSAR establishes agency 

acquisition rules and guidance which 

contains agency acquisition policies and 

practices, contract clauses, solicitation 

provisions, and forms that control the 

relationship between GSA and 

contractors and prospective contractors. 

II. Statement of Regulatory and 

Deregulatory Priorities 

FTR Regulatory Priorities 

GSA plans, in fiscal year 2011, to 

amend the FTR by: 

• Revising the Relocation Income Tax 

(RIT) Allowance; amending coverage 

on family relocation; 

• Amending the calculations regarding 

the commuted rate for employeemanaged household good shipments; 

• Removing the Privately Owned 

Vehicle (POV) rates from the FTR; 

amending reimbursement for 

employees staying in their privately 

owned homes/condos while on TDY; 

and 

• Revising policies within the FTR 

regarding the definition and coverage 

of domestic partners (to include same 

sex partners). Also, GSA plans to fully 

revise the FTR. This revision will 

begin during fiscal year 2011. 

FMR Regulatory Priorities 

GSA plans, in fiscal year 2011, to 

amend the FMR by: 

• Revising rules regarding management 

of government aircraft; 

• Revising rules regarding mail 

management; 

• Amending coverage in motor vehicle 

management by revising the 

definition of ‘‘motor vehicle rental’’; 

• Incorporating and migrating the 

provisions of the Federal Property 

Management Regulations (FPMR) 

regarding purchase of new motor 

vehicles from the to the FMR; 

• Incorporating and migrating the 

provisions of the Interagency Fleet 

Management Systems from the 

Federal Property Management 

Regulations (FPMR) into the FMR; 

• Amending transportation 

management regulations by revising 

coverage on open skies agreements, 

obligation authority and training for 

civilian transportation officers, and 

transportation data collection; 

• Amending Transportation 

Management and Audit by revising 

the requirements regarding the refund 

of unused and expired tickets; 

• Amending policy covering personal 

property to promote open government 

and disclosure by updating the 

requirements for submission of 

annual reports to use the automated 

reporting tool; 

• Updating procedures for handling the 

transfer of Title for vehicles to donees 

via State Agencies for Surplus 

Property; removing activities related 

to the Federal Asset Sales program 

which initiated the program; 

• Removing aircraft and aircraft-related 

parts from the exchange/sale 

prohibited list; and 

• Migrating policy (including policy 

regarding supply and procurement) 

from the FPMR to the FMR. 

GSAR Regulatory Priorities 

GSA plans, in fiscal year 2011, to 

finalize the rewrite of the GSAR to 

maintain consistency with the Federal 

Acquisition Regulation (FAR) and to 

implement streamlined and innovative 

acquisition procedures that contractors, 

offerors, and GSA contracting personnel 

can utilize when entering into and 

administering contractual relationships. 

Currently, there are only a few parts of 

the GSAR rewrite effort still 

outstanding. 

GSA is clarifying the GSAR by— 

• Providing consistency with the FAR; 

• Eliminating coverage that duplicates 

the FAR or creates inconsistencies 

within the GSAR; 

• Correcting inappropriate references 

listed to indicate the basis for the 

regulation; 

• Rewriting sections that have become 

irrelevant because of changes in 

technology or business processes or 

that place unnecessary administrative 

burdens on contractors and the 

Government; 

• Streamlining or simplifying the 

regulation; 

• Rolling up coverage from the services 

and regions/zones that should be in 

the GSAR; 

• Providing new and/or augmented 

coverage; and 

• Deleting unnecessary burdens on 

small businesses. 

GSAR Proposed Rule 

GSA proposes to provide the Agency 

Protest Official the discretion to require 

one or more protest parties to 

participate in oral presentations and/or 

submit additional written material 

related to the protest issues. 

Regulations of concern to small 

businesses 

FAR and GSAR rules are relevant to 

small businesses who do or wish to do 

business with the Federal Government. 

Approximately 18,000 businesses, most 

of whom are small, have GSA schedule 

contracts. GSA assists its small 

businesses by providing assistance 

through its Office of Small Business 

Utilization. 

Regulations which promote open 

government and disclosure 

While there are currently no 

regulations which promote open 

government and disclosure, all 

government contract spend transactions 

are available online through Federal 


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Procurement Data System-Next 

Generation (FPDS-NG). 

Regulations required by statute or court 

order 

There are no regulations required by 

statute or court order. 

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NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION (NASA) 

Statement of Regulatory Priorities 

NASA plans to publish its 2011 

Strategic Plan to accompany its FY 2012 

budget request. NASA’s mission, as 

stated in the draft 2011 Strategic Plan, 

is to ‘‘drive advances in science, 

technology, and exploration to enhance 

knowledge, education, innovation, 

economic vitality, and stewardship of 

the Earth.’’ This updated mission 

statement reflects NASA’s practice of 

ensuring the knowledge and 

technologies developed to accomplish 

its missions are transferred to the public 

sector through programs, partnerships, 

and public outreach and engagement 

activities in ways that support the 

Administration’s priorities. 

Through a framework of six strategic 

goals, NASA’s 2011 Strategic Plan 

guides our missions in human and 

robotic exploration, scientific discovery 

in earth and space science, technology 

innovation and development, and 

aeronautics research. The framework 

also includes strategic planning for 

NASA’s human and institutional 

capabilities, which are critical to the 

success of our current and future 

missions, as well as the programs, to 

ensure the widest dissemination and 

use of NASA’s results for the benefit of 

the Nation. The following strategic goal 

framework is intended to span a 20+ 

year horizon. The outcomes and more 

detailed objectives that flow from the 

strategic goals are also defined in the 

Strategic Plan and used to guide nearer 

term Agency activities: 

Goal 1: Extend and sustain human 

activities across the solar system. 

Goal 2: Expand scientific 

understanding of Earth and the universe 

in which we live. 

Goal 3: Create innovative new space 

technologies for our exploration, 

science, and economic future. 

Goal 4: Advance aeronautics research 

for societal benefit. 

Goal 5: Enable program and 

institutional capabilities to conduct 

NASA’s aeronautics and space 

activities. Goal 6: Share NASA with the 

public, educators, and students to 

provide opportunities to participate in 

our mission, foster innovation, and 

contribute to a strong national economy. 

In the decades since Congress enacted 

the National Aeronautics and Space Act 

of 1958, NASA has challenged its 

scientific and engineering capabilities in 

pursuing its mission, while 

simultaneously generating tremendous 

results and benefits for humankind. 

NASA’s founding legislation also 

instructed NASA to ‘‘...provide for the 

widest practicable and appropriate 

dissemination of information...’’ is a key 

principle of the Administration’s Open 

Government initiative, and one that 

NASA has embedded in its operations 

for 50 plus years. NASA recognizes that 

‘‘open government’’ is a process rather 

than a product and has taken a 

continuous-learning approach as 

outlined in Version 1.0 of the NASA 

Open Government Plan 

(http://www.nasa.gov/open/ 

index.html). We strive to continuously 

improve the way in which we operate 

under OpenGov and are participating in 

related Administration initiatives, such 

as performance improvement (High 

Priority Performance Goals) and 

contributions of ‘‘high value’’ raw data 

sets and tools to Data.gov. NASA has 

also articulated in its strategic plan 

several overarching strategies that 

reflect the Administration’s national 

priorities and are the basis of how we 

continue to govern the conduct of our 

work. 

• Investing in next-generation 

technologies and approaches to spur 

innovation; 

• Inspiring students to be our future 

scientists and engineers, explorers, 

and educators through interactions 

with NASA’s people, missions, 

research, and facilities; 

• Expanding partnerships with 

international, intergovernmental, 

academic, industrial, and 

entrepreneurial communities as 

important contributors of skill and 

creativity to our missions and for the 

propagation of our results; 

• Committing to environmental 

stewardship through Earth 

observation and science, and the 

development and use of green 

technologies and capabilities in 

NASA missions and facilities; and 

• Securing the public trust through 

transparency and accountability in 

our programmatic and financial 

management, procurement, and 

reporting practices. 

The Federal Acquisition Regulation 

(FAR), 48 CFR chapter 1, contains 

procurement regulations that apply to 

NASA and other Federal agencies. As a 

member of the Federal Acquisition 

Regulatory Council and a FAR 

signatory, NASA participates with other 

Federal agencies to implement 

regulatory changes. In many cases, 

legislation provides the basis for 

changes to the procurement regulations. 

Change is also driven by case law, 

agency needs, and opportunity for 

improvement. In addition to its Federal 

role on the FAR Council, NASA 

implements and supplements FAR 

requirements through it’s internal 

procurement regulations, the NASA 

FAR Supplement (NFS), 48 CFR chapter 

18. For the most part, NASA’s 

procurement regulations are procedural; 

they lay out the framework and 

processes by which to implement the 

Federal regulations. NASA does not 

plan any major NFS revisions in FY 

2011. In a continuing effort to keep the 

NFS current and to implement NASA 

initiatives and Federal procurement 

policy, minor revisions to the NFS will 

be published. 

NASA is planning to add a subpart to 

its regulations that will set forth policies 

and procedures relating to requirements 

for the filing of claims against NASA 

where a potential claimant believes 

NASA is infringing on privately owned 

rights in patented inventions or 

copyrighted works. The proposed 

regulations will set forth guidelines as 

to what NASA considers as necessary to 

file a claim for patent or copyright 

infringement. 

The National Aeronautics and Space 

Administration (NASA) is proposing 

revisions to its regulations for 

implementing the National 

Environmental Policy Act of 1969 

(NEPA) and the Council on 

Environmental Quality (CEQ) Code of 

Federal Regulations (CFR) (40 CFR parts 

1500 to 1508). This proposed rule 

would replace procedures contained in 

NASA’s current regulation at 14 CFR 

1216.3, Procedures for Implementing the 

National Environmental Policy Act. The 

revision is necessary to clarify and 

update the current regulation. Since the 

previous major update of NASA’s NEPA 

regulation in 1988, a number of 

Executive orders have streamlined the 

Federal Government through 

decentralization, reduction, and 

simplification of regulations, and 

management of risk. This proposed rule 

strives to meet the spirit of these 

Executive orders, while expanding the 

Categorical Exclusions in keeping with 

NASA’s mission. 

Regulations That Are of Particular 

Concern to Small Businesses 

Regulations in FAR part 19—Small 

Business Programs, in particular FAR19.5, FAR-19.8, FAR-19.13, and FAR19.14, which address the various 

categories of small business, have 

caused confusion with both the small 


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businesses and Federal Contracting 

Officers. FAR-19.13, which addresses 

the Historically Underutilized Business 

Zone (HUBZone) Programs, in particular 

section 19.1305 (a) states, ‘‘A 

participating agency contracting officer 

shall set aside acquisitions exceeding 

the simplified acquisition threshold for 

competition restricted to HUBZone 

small business concerns ....’’ For the 

remaining categories of small business 

that allow set-a-sides, the FAR states 

either ‘‘may’’ or ‘‘should’’ be set-a-side. 

Over the past year or so, there have 

been numerous GAO and Court 

decisions that have held up protests 

from HUBZone companies saying that 

the Government can only award to 

HUBZone companies because the FAR 

states ‘‘shall’’ award and the other 

programs state either ‘‘may’’ or 

‘‘should.’’ Both the Small Business 

Administration (SBA) and the Office of 

Management and Budget (OMB) have 

issued direction to the Federal agencies 

stating, ‘‘The GAO’s Decisions are not 

binding on Federal agencies and are 

contrary to regulations promulgated by 

the Small Business Administration 

(SBA) that provide for ‘‘parity’’ among 

the three small business programs.’’ 

The resulting environment is one in 

which Federal agencies are at 

significantly increased risk of upheld 

contract award protests, delayed 

procurements, and failure to meet small 

business goals in certain categories. 

Statutory changes are likely required in 

order to clarify FAR 19 and resolve the 

situation which greatly impacts the 

small business community. 

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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 two regulatory priorities 

for fiscal year 2010, which is included 

in The Regulatory Plan. The first is the 

drafting of regulations for the Office of 

Government Information Services 

(OGIS), established under the OPEN 

Government Act of 2007. OGIS has a 

two-pronged mission: (1) Review 

policies and procedures of 

administrative agencies under the 

Freedom of Information Act (FOIA); 

review compliance with FOIA by 

administrative agencies; and 

recommend policy changes to Congress 

and the President to improve the 

administration of FOIA; and (2) to 

provide mediation services to resolve 

disputes between FOIA requesters and 

agencies. OGIS also serves as the FOIA 

Ombudsman. 

The second priority is an update to 

NARA’s regulations related to 

declassification of classified national 

security information in records 

transferred to NARA’s legal custody. 

The rule incorporates changes resulting 

from promulgation of Executive Order 

13526, Classified National Security 

Information. These changes include 

establishing procedures for the 

automatic declassification of records in 

NARA’s legal custody and revising 

requirements for reclassification of 

information to meet the provisions of 

E.O. 13526. Executive Order 13526 also 

created the National Declassification 

Center (NDC) with a mission to align 

people, processes, and technologies to 

advance the declassification and public 

release of historically valuable 

permanent records while maintaining 

national security. 

NARA 

PROPOSED RULE STAGE 

158. OFFICE OF GOVERNMENT 

INFORMATION SERVICES 

Priority: 

Other Significant 

Legal Authority: 

PL 110–175 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

The Office of Government Information 

Services (OGIS), established under the 

OPEN Government Act of 2007, is 

responsible for reviewing policies and 

procedures of administrative agencies 

under the Freedom of Information Act 

(FOIA); reviewing compliance with 

FOIA by administrative agencies; and 

recommending policy changes to 

Congress and the President to improve 

the administration of FOIA. 

Statement of Need: 

The Office of Government Information 

Services (OGIS), established under the 

OPEN Government Act of 2007, may 

require implementing regulations. 

Summary of Legal Basis: 

The Open Government Act of 2007 

(Pub. L. 110-175) requires the 

establishment of an Office of 

Government Information Services 

within NARA. OGIS will oversee 

Freedom of Information Act (FOIA) 

activities Governmentwide. 

Anticipated Cost and Benefits: 

OGIS, as an organization responsible 

for reviewing policies and procedures 

of administrative agencies under the 

Freedom of Information Act (FOIA); 

reviewing compliance with FOIA by 

administrative agencies; and 

recommending policy changes to 

Congress and the President to improve 

the administration of FOIA, is expected 

to increase the efficiency of the FOIA 

process. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Final Action 02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Federal 

Agency Contact: 

Laura McCarthy 

National Archives and Records 

Administration 

8601 Adelphi Road 

College Park, MD 20740 

Phone: 301 837–3023 

Email: laura.mccarthy@nara.gov 

RIN: 3095–AB62 

NARA 

159. DECLASSIFICATION OF 

NATIONAL SECURITY INFORMATION 

Priority: 

Other Significant. Major status under 5 

USC 801 is undetermined. 

Legal Authority: 

EO 13526 

CFR Citation: 

36 CFR 1260 

Legal Deadline: 

None 

Abstract: 

Executive Order 13526, Classified 

National Security Information, 

mandates changes to National Security 

Information declassification processes. 

NARA is updating its regulations to 

incorporate these changes. 

Statement of Need: 

Executive Order 13526, Classified 

National Security Information, 

mandates changes to National Security 

Information declassification processes 

including the establishment of the 

National Declassification Center (NDC). 

NARA is updating its regulations to 

incorporate these changes. 

Summary of Legal Basis: 

Executive Order 13526, Classified 

National Security Information, 

mandates changes to National Security 

Information declassification processes 

including the establishment of the 

National Declassification Center (NDC). 


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Anticipated Cost and Benefits: 

Executive Order 13526 created the 

National Declassification Center (NDC) 

with a mission to align people, 

processes, and technologies to advance 

the declassification and public release 

of historically valuable permanent 

records while maintaining national 

security. 

Timetable: 

Action Date FR Cite 

NPRM 12/00/10 

Action Date FR Cite 

NPRM Comment 

Period End 

02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Federal 

Agency Contact: 

Marilyn Redman 

National Archives and Records 

Administration 

8601 Adelphi Road 

College Park, MD 20740 

Phone: 301 837–3174 

Email: marilyn.redman@nara.gov 

RIN: 3095–AB64 

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OFFICE OF PERSONNEL 

MANAGEMENT (OPM) 

Statement of Regulatory Priorities 

The Office of Personnel 

Management’s mission is to ensure the 

Federal Government has an effective 

civilian workforce. OPM fulfills that 

mission by, among other things, 

providing human capital advice and 

leadership for the President and Federal 

agencies; delivering human resources 

policies, products, and services; and 

holding agencies accountable for their 

human capital practices. OPM’s 2010 

regulatory priorities are designed to 

support these activities. 

Pay System for Senior Professionals 

(SL/ST) 

OPM proposes to amend rules for 

setting and adjusting pay of senior-level 

(SL) and scientific and professional (ST) 

employees. The Senior Professional 

Performance Act of 2008 changed pay 

for these employees by eliminating their 

previous entitlement to locality pay and 

providing instead for rates of basic pay 

up to the rate payable for level III of the 

Executive Schedule (EX-III), or if the 

employee is under a certified 

performance appraisal system, the rate 

payable for level II of the Executive 

Schedule (EX-II). Consistent with this 

statutory emphasis on performancebased pay, these regulations will 

provide more flexible rules for agencies 

to set and adjust pay for SL and ST 

employees based primarily upon 

individual performance, contribution to 

the agency’s performance, or both, as 

determined under a rigorous 

performance appraisal system. 

Sick Leave 

OPM anticipates issuing final 

regulations to entitle an employee to use 

sick leave to provide care for a family 

member when the relevant health 

authorities or a health care provider 

have determined that the family 

member’s presence in the community 

would jeopardize the health of others 

because of the family member’s 

exposure to a communicable disease. 

The final regulations would also permit 

agencies to advance a maximum of 240 

hours (30 days) of sick leave to an 

employee if the employee’s presence on 

the job would jeopardize the health of 

others because of exposure to a 

communicable disease and to advance a 

maximum of 104 hours (13 days) of sick 

leave to an employee to provide care for 

a family member who would jeopardize 

the health of others by that family 

member’s presence in the community 

because of exposure to a communicable 

disease. 

Benefits for Reservists and their Family 

Members 

Qualifying exigencies 

OPM anticipates issuing proposed 

regulations to implement section 

565(b)(1) of the National Defense 

Authorization Act (NDAA) for Fiscal 

Year (FY) 2010 (Pub. L. 111-84; Oct. 28, 

2009) that amends the Family and 

Medical Leave Act (FMLA) provisions at 

5 U.S.C. 6381 to 6383 to add qualifying 

exigencies to the circumstances or 

events that entitle Federal employees to 

up to 12 administrative workweeks of 

FMLA unpaid leave during any 12- 

month period. The proposed regulations 

would amend OPM’s current regulations 

at part 630, subpart L, to cover 

qualifying exigencies when the spouse, 

son, daughter, or parent of the employee 

is on covered active duty in the Armed 

Forces or has been notified of an 

impending call or order to covered 

active duty. OPM proposes eight 

categories of qualifying exigencies: 

Short-notice deployments, military 

events and related activities, childcare 

and school activities, financial and legal 

arrangements, counseling, rest and 

recuperation, post-deployment 

activities, and additional activities not 

encompassed in the other categories 

when the agency and employee agree 

they qualify as exigencies, including the 

timing and duration of the leave. 

Reservist Differential 

OPM will also continue to support 

Federal civilian employees called to 

active duty to further serve our Nation. 

OPM anticipates issuing proposed 

regulations to implement statutory 

changes that provide a new benefit to 

Federal civilian employees who are 

members of the Reserve or National 

Guard and who are called or ordered to 

active duty. Section 751 of the Omnibus 

Appropriations Act, 2009 (Pub. L. 111- 

8; March 11, 2009) established a new 

provision in 5 U.S.C. 5538 that became 

effective on March 15, 2009. Under this 

new law, eligible Federal civilian 

employees called to active duty may 

receive a reservist differential. The 

reservist differential is equal to the 

amount by which an employee’s 

projected civilian ‘‘basic pay’’ for a 

covered pay period exceeds the 

employee’s actual military ‘‘pay and 

allowances’’ allocable to that pay 

period. While each employing civilian 

agency is responsible for making these 

payments, OPM, in consultation with 

the Department of Defense, is required 

to issue regulations to implement the 

new benefit. 

Suitability Reinvestigations 

OPM is reopening the comment 

period for proposed regulations 

published on November 3, 2009. The 

proposed rule modifies the suitability 

regulations in 5 CFR 731 to assist 

agencies in carrying out new 

requirements to reinvestigate 

individuals in public trust positions 

under Executive Order 13488, Granting 

Reciprocity on Excepted Service and 

Federal Contractor Employee Fitness 

and Reinvestigating Individuals in 

Positions of Public Trust, to ensure their 

continued employment is appropriate. 

This reopener provides additional 

information relative to the scope of 

reinvestigations for public trust 

positions in order to allow for further 

comment as to reinvestigation 

frequency. 

Designation of National Security 

Positions 

OPM is proposing to revise its 

regulation regarding designation of 

national security positions. This 

proposed rule is one of a number of 

initiatives OPM has undertaken to 

simplify and streamline the system of 

Federal Government investigative and 

adjudicative processes to make them 

more efficient and as equitable as 

possible. The purpose of this revision is 

to clarify the requirements and 

procedures agencies should observe 

when designating national security 

positions as required under Executive 

Order 10450, Security Requirements for 

Government Employment. The proposed 

regulations clarify the categories of 

positions, which by virtue of the nature 

of their duties, have the potential to 

bring about a material adverse impact 

on the national security, whether or not 

the positions require access to classified 

information. The proposed regulations 

also acknowledge, for greater clarity, 

complementary requirements set forth 

in part 731, Suitability, so that every 

position is properly designated with 

regard to both public trust risk and 

national security sensitivity 

considerations. Finally, the proposed 

rule clarifies when reinvestigation of 

individuals in national security 

positions is required. 

Personnel Investigations 

OPM is participating in a review of 

the Federal Government’s requirements 

for access to classified information and 

for suitability for employment. This 

review covers relevant statutes, 

Executive orders, and Governmentwide 


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regulations and is intended to determine 

whether a reengineered system that is 

cohesive, simplified, and equitable as 

possible can be developed. In particular, 

a reengineered system may require 

adjustments to OPM’s regulations on 

personnel investigations. 

Procedures for States and Localities to 

Request Indemnification 

The Office of Personnel Management 

(OPM) is participating in a review of the 

Federal Government’s requirements for 

access to classified information and for 

suitability for employment. This review 

covers relevant statutes, Executive 

orders, and Governmentwide 

regulations and is intended to determine 

whether a reengineered system that is 

cohesive, simplified, and equitable as 

possible can be developed. In particular, 

a reengineered system may require 

adjustments to OPM’s regulations 

indemnification. OPM is also issuing a 

plain language rewrite of the regulation 

and the regulation will revise the part to 

be consistent with 5 U.S.C. 9101 (Pub. 

L. 99-169), as amended. 

BILLING CODE 6325–44–S 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79681 

PENSION BENEFIT GUARANTY 

CORPORATION (PBGC) 

Statement of Regulatory and 

Deregulatory Priorities 

The Pension Benefit Guaranty 

Corporation (PBGC) protects the 

pensions of about 44 million people in 

about 29,000 privately defined benefit 

plans. PBGC receives no funds from 

general tax revenues. Operations are 

financed by insurance premiums, 

investment income, assets from pension 

plans trusteed by PBGC, and recoveries 

from the companies formerly 

responsible for the trusteed plans. 

To carry out these functions, PBGC 

issues regulations interpreting such 

matters as the termination process, 

establishment of procedures for the 

payment of premiums, reporting and 

disclosure, and assessment and 

collection of employer liability. The 

Corporation is committed to issuing 

simple, understandable, and timely 

regulations to help affected parties. 

PBGC’s intent is to issue regulations 

that implement the law in ways that do 

not impede the maintenance of existing 

defined benefit plans or the 

establishment of new plans. Thus, the 

focus is to avoid placing burdens on 

plans, employers, and participants, 

wherever possible. PBGC also seeks to 

ease and simplify employer compliance 

whenever possible. 

PBGC Insurance Programs 

PBGC administers two insurance 

programs for privately 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, when a 

plan terminates with insufficient 

assets to cover all plan benefits 

(distress and involuntary 

terminations), PBGC pays plan 

benefits that are guaranteed under 

title IV. PBGC also pays 

nonguaranteed plan benefits to the 

extent funded by plan assets or 

recoveries from employers. 

• Multiemployer Program. The smaller 

multiemployer program covers about 

1,500 collectively bargained plans 

involving more than one unrelated 

employer. 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. 

At the end of fiscal year 2010, PBGC 

had a $23 billion deficit in its insurance 

programs. 

Regulatory Objectives and Priorities 

As described below, PBGC’s current 

regulatory objectives and priorities are 

to complete implementation of the 

Pension Protection Act of 2006 (PPA 

2006) by issuing simple, 

understandable, and timely regulations 

that do not impose undue burdens that 

could impede maintenance or 

establishment of defined benefit plans. 

PBGC is also working on several 

regulatory projects not related to PPA 

2006. These regulatory objectives and 

priorities are developed in the context 

of the Corporation’s statutory purposes: 

• To encourage voluntary private 

pension plans; 

• To provide for the timely and 

uninterrupted payment of pension 

benefits; and 

• To keep premiums at the lowest 

possible levels. 

PBGC also attempts to minimize 

administrative burdens on plans and 

participants, improve transparency, 

simplify filing, provide relief for small 

businesses, and assist plans to comply 

with applicable requirements. 

Transparency 

The Corporation seeks to improve 

transparency of information to plan 

participants, plan sponsors, and PBGC, 

in order to make disclosure and 

reporting more meaningful and to 

encourage more responsible funding of 

pension plans. 

PPA 2006 affected certain provisions 

in the PBGC’s reportable events 

regulation, which requires employers to 

notify PBGC of certain plan or corporate 

events. In November 2009, PBGC 

published a proposed rule to conform 

the regulation to the PPA 2006 changes. 

The proposed rule would also eliminate 

most of the automatic waivers and filing 

extensions currently provided and make 

other amendments to enhance the 

regulation as a regulatory tool. PBGC 

expects to finalize this regulation, taking 

into account public comments, in late 

2010. 

PBGC has issued final rules to 

implement other reporting and 

disclosure provisions of PPA 2006. In 

November 2008, PBGC issued a 

regulation that requires disclosure of 

certain information to participants 

regarding the termination of their 

underfunded plan. In March 2009, 

PBGC issued a final regulation making 

PPA 2006 changes to the plan actuarial 

and employer financial information 

required under section 4010 of ERISA to 

be reported to PBGC by employers with 

large amounts of pension underfunding. 

Reducing burden through electronic 

filing 

PBGC has simplified filing by 

increasing use of electronic filing 

methods. Electronic filing of premium 

information has been mandatory for all 

plans for plan years beginning on or 

after January 1, 2007. Filers have a 

choice of using private-sector software 

that meets PBGC’s published standards 

or using PBGC’s software. Electronic 

premium filing simplifies filers’ 

paperwork, improves accuracy of 

PBGC’s premium records and database, 

and enables more prompt payment of 

premium refunds. Most of the premium 

changes under PPA 2006 have now been 

incorporated into software so that it will 

be easy to comply with the premium 

changes under the new law. 

Employers with large amounts of 

underfunding in their plans must file 

actuarial and financial information 

under section 4010 of ERISA 

electronically. Electronic filing reduces 

the filing burden, improves accuracy, 

and better enables PBGC to monitor and 

manage risks posed by these plans. 

PBGC incorporated the PPA 2006 

changes to this reporting into software 

so that it will be easy to comply with 

the reporting changes under the new 

law. 

Small businesses 

PBGC gives consideration to the 

special needs and concerns of small 

businesses in making policy. A large 

percentage of the plans insured by 

PBGC are small or maintained by small 

employers. The first regulation PBGC 

published under PPA 2006 

implemented the cap on the variablerate premium for plans of small 

employers; the final regulation was 

published in December 2007. In early 

2011, the Corporation expects to issue a 

proposed regulation implementing the 

expanded missing participants program 

under PPA 2006, which will also benefit 

small businesses. 

Other PPA 2006 changes 

Under PPA 2006, if a plan terminates 

while its sponsor is in bankruptcy, and 

the bankruptcy was initiated on or after 

September 16, 2006, the bankruptcy 

filing date is treated as the plan 

termination date for purposes of 

determining the amount of benefits 


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PBGC guarantees and the amount of 

assets allocated to participants who 

retired or have been retirement-eligible 

for 3 years. In 2008, PBGC published a 

proposed regulation to implement this 

statutory change; PBGC expects to 

finalize the regulation in late 2010. 

PPA 2006 changes the rules for 

determining benefits upon the 

termination of a statutory hybrid plan, 

such as a cash balance plan. PBGC plans 

to publish a proposed regulation in late 

2010 to implement those rules in both 

PBGC-trusteed plans and in plans that 

close out in the private sector. 

Under PPA 2006, the phase-in period 

for the guarantee of a benefit payable 

solely by reason of an ‘‘unpredictable 

contingent event,’’ such as a plant 

shutdown, starts no earlier than the date 

of the shutdown or other unpredictable 

contingent event. PBGC plans to publish 

a proposed regulation implementing 

this statutory change in late 2010. 

Compliance assistance 

PBGC has initiated a regulatory 

project to assist plans to comply with 

requirements applicable to certain 

substantial cessations of operations. 

ERISA section 4062(e) provides for 

reporting of and liability for certain 

substantial cessations of operations by 

employers that maintain singleemployer plans. In July 2010, PBGC 

published a proposed regulation that 

provides guidance as to what constitutes 

a section 4062(e) event, on the reporting 

of such an event to PBGC, and on the 

determination and satisfaction of 

liability arising from such an event. 

Issuance of the guidance is expected to 

improve 4062(e) reporting as a 

regulatory tool. 

Reemployed service members’ pension 

benefits 

In 2010, PBGC published a final 

regulation that implementing provisions 

of the Uniformed Services Employment 

and Reemployment Rights Act of 1994 

(USERRA). USERRA provides that an 

individual who leaves a job to serve in 

the uniformed services is generally 

entitled to reemployment by the 

previous employer and, upon 

reemployment, to receive credit for 

benefits, including employee pension 

plan benefits, that would have accrued 

but for the employee’s absence due to 

the military service. The regulation 

provides that so long as a service 

member is reemployed within the time 

limits set by USERRA, even if the 

reemployment occurs after the plan’s 

termination date, PBGC treats the 

participant as having satisfied the 

reemployment condition as of the 

termination date. This ensures that the 

pension benefits of reemployed service 

members, like those of other employees, 

will generally be guaranteed for periods 

up to the plan’s termination date. 

PBGC will continue to look for ways 

to further improve its regulations. 

BILLING CODE 7709–01–S 


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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79683 

SMALL BUSINESS ADMINISTRATION 

(SBA) 

Statement of Regulatory Priorities 

Overview 

The mission of the U.S. Small 

Business Administration (SBA) 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 carrying 

out this mission, SBA strives to improve 

the economic and regulatory 

environment for small businesses, 

especially those in areas that have 

significantly higher unemployment and 

lower income levels than the Nation’s 

averages and those in traditionally 

underserved markets. The Agency 

serves as a direct lender or guarantor of 

small business loans and provides 

management and technical assistance 

and contracting opportunities to small 

businesses. The Agency also provides 

direct financial assistance to 

communities that have experienced 

catastrophes. This assistance is a critical 

factor in rebuilding the devastated 

economy and community. 

SBA’s regulatory policy encompasses 

these goals and objectives and is 

implemented primarily through several 

core program offices: Office of Capital 

Access, Office of Government 

Contracting and Business Development, 

Office of Entrepreneurial Development, 

and Office of Disaster Assistance. Other 

offices, such as the Office of Veterans 

Business Development and Office of 

Native American Affairs also play a role 

in developing and shaping Agency 

regulatory policies that affect veterans, 

American Indians, Alaska Natives, 

Native Hawaiians, and the indigenous 

people of Guam and American Samoa. 

SBA’s fall 2009 regulatory plan focused 

on a cross section of regulations that 

encompassed practically all of these 

program areas. To date SBA has 

successfully implemented all but one of 

the five regulatory priorities identified 

in that fall 2009 plan. The remaining 

regulatory priority, which impacts 

SBA’s major small business 

development programs, is included in 

the SBA fall 2010 regulatory plan. The 

other fall 2010 regulatory rules are to 

implement the recently enacted Small 

Business Jobs Act of 2010. 

Openness and Transparency 

SBA is committed to developing 

regulations that are clear, simple, and 

easily understood. In addition, 

consistent with the President’s mandate, 

SBA continues to promote transparency, 

collaboration, and public participation 

in its rulemakings. To that end, SBA 

routinely solicits comments on its 

regulations, even those that are not 

subject to the public notice and 

comment requirement under the 

Administrative Procedures Act, and 

where appropriate, the Agency consults 

with other Federal agencies or other 

entities that the regulation might affect. 

SBA’s regulatory process also includes 

an assessment of the relative costs and 

benefits of the Agency’s regulations as 

required by Executive Order 12866 

‘‘Regulatory Planning and Review,’’ as 

well as an analysis under the Regulatory 

Flexibility Act of whether regulations 

will have a significant economic impact 

on small businesses or entities. 

Reducing Paperwork Burden on Small 

Businesses 

SBA’s various program offices are 

engaged in an ongoing effort to meet the 

goals of the Paperwork Reduction Act. 

The Agency develops regulations that, 

to the extent possible, reduce or 

eliminate the burden on the public. The 

Agency also endeavors to meet the 

requirements of the Government 

Paperwork Elimination Act, as well as 

the E-Government Act, by making 

available various electronic options for 

doing business with the Agency. These 

electronic options include applications 

for financial assistance, participation in 

government contracting and surety bond 

assistance programs, applications for 

grants, and transmittal of loan reporting 

data. 

Regulatory Framework 

The SBA recently released a new 

strategic plan that will serve as the 

foundation for the regulations that the 

Agency will develop during fiscal years 

2011 through 2016. This plan is based 

on three primary strategic goals: 

Growing businesses and creating jobs; 

building an SBA that meets needs of 

today’s and tomorrow’s small 

businesses; and serving as the voice for 

small business. In order to achieve these 

goals SBA will, among other objectives, 

focus on: 

• Expanding small business’ access to 

capital through SBA’s extensive 

lending network. 

• Ensuring Federal contracting goals are 

met or exceeded by collaborating 

across the Federal Government to 

expand opportunities for small 

businesses and strengthen the 

integrity of the Federal contracting 

data and certification process. 

• Ensuring that SBA’s disaster 

assistance resources for businesses, 

non-profit organizations, 

homeowners, and renters can be 

deployed quickly, effectively, and 

efficiently. 

• Strengthening SBA’s relevance to high 

growth entrepreneurs and small 

businesses to more effectively drive 

innovation and job creation. 

• Mitigating risk to taxpayers and 

improving program oversight. 

Regulatory Priorities 

As reported in the Agency’s fall 2010 

regulatory agenda, SBA plans to publish 

several regulations during the coming 

year that are designed to achieve these 

goals. Over the next 12 months, SBA’s 

highest regulatory priorities will include 

implementation of new programs or 

changes to existing programs that are 

mandated by the recently enacted Small 

Business Jobs Act of 2010 (Jobs Act). 

SBA will focus particularly on issuing 

regulations for those programs that will 

provide increased access to capital and 

contract opportunities for small 

businesses. SBA also plans to make 

implementation of comprehensive 

changes to the regulations governing the 

SBA 8(a) Business Development (8(a) 

BD) and Small Disadvantaged Business 

(SDB) programs, one of the Agency’s 

highest priorities. 

(1) Implementation of Jobs Act: 

(a) Small Business Access to Capital 

One of SBA’s top priorities will be to 

amend the Certified Development 

Company Program (commonly referred 

to as the 504 Program) regulations to 

implement section 1122 of the Jobs Act. 

This section authorizes SBA to conduct 

a 2-year program under which 

borrowers may use proceeds from an 

SBA guaranteed loan to refinance 

certain debt. On June 23, 2009, as 

authorized by the American Recovery 

and Reinvestment Act of 2009 (Recovery 

Act), SBA published a rule that 

permitted the use of proceeds from a 

504 loan to refinance debt related to the 

expansion of a small business. This rule 

would provide an added benefit to small 

businesses by allowing them to 

refinance debt for purposes other than 

expansion of the business. 

Section 1131 of the Jobs Act 

authorizes SBA to establish a Small 

Business Intermediary Lending Pilot 

Program. This 3-year pilot program is 

intended to provide funds to private 

non-profit entities to make loans to 

eligible small businesses that are 

suffering from a lack of credit as a result 

of poor economic conditions or changes 

in the financial market. In order to give 

full effect to this purpose, SBA will also 


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79684 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

prioritize implementation of this 

lending program. 

(b) Small Business Federal 

Contracting Opportunities: 

The Jobs Act also makes several 

changes to SBA’s contracting programs. 

These changes are intended to increase 

Federal procurement opportunities for 

small businesses and strengthen their 

ability to compete for such contracts. 

Among other things, the changes 

address the challenges small businesses 

face when attempting to subcontract 

with prime contractors and provide 

contracting officers with options for 

setting aside orders on multiple award 

contracts, place limitations on contract 

bundling by agencies, and establish a 

Governmentwide mentor-prote ́ge ́

program for participants in certain SBA 

programs. This regulatory plan 

highlights issuance of regulations to 

govern the terms and conditions for 

setting aside portions of multiple award 

contracts for small businesses. However, 

as identified in the Agency’s regulatory 

agenda, SBA also plans to develop other 

regulations where necessary to establish 

guidelines for implementing other 

changes authorized by the Jobs Act. 

(2) Other Regulatory Priority 

In addition to implementing these 

Jobs Act provisions, SBA will also focus 

on implementing changes to the 8(a) 

Business Development (8(a) BD) and 

Small Disadvantaged Business (SDB) 

programs. This major regulatory action 

signifies the first comprehensive 

amendment to the 8(a) BD program in 

more than a decade. Among other 

things, the changes are intended to 

prevent large businesses as well as other 

non-8(a) firms from being able to reap 

the benefits of sole source contracts 

intended for tribally owned or Alaska 

Native Corporation-owned 8(a) 

Participants. Through experience with 

the program and in listening to program 

participants or potential participants, 

SBA has learned that some program 

requirements are too restrictive and 

serve to unfairly preclude firms from 

being admitted to the program. In other 

cases, the requirements are deemed too 

expansive or indefinite. SBA will make 

changes that restrict or clarify such 

rules. Additional details regarding this 

regulation are described below in the 

Agency’s regulatory plan. 

In keeping with the President’s call 

for a more open and transparent 

Government, during the development of 

this major regulation, SBA conducted 

several public meetings to engage the 

public in the rule formulation process. 

SBA also consulted with various tribal 

governments as required by Executive 

Order 13175 ‘‘Tribal Consultations’’ in 

several regions of the country. The final 

regulation will reflect these public 

discussions and tribal consultations and 

will benefit small business by clarifying 

SBA’s requirements, removing 

confusion, and eliminating or easing 

restrictions that are unnecessary. 

The 8(a)BD program serves as a good 

example of SBA’s commitment to 

simplifying the process of conducting 

business with the Agency. The Agency 

has provided applicants for the 8(a)BD 

program the option of filing their 

applications and related documents for 

program participation electronically. 

This electronic option goes a long way 

to reduce the time and money 

applicants spend responding to Agency 

program requirements. 

SBA 

PROPOSED RULE STAGE 

160. ∑ SMALL BUSINESS JOBS ACT: 

MULTIPLE AWARD CONTRACTS AND 

SMALL BUSINESS SET–ASIDES 

Priority: 

Other Significant 

Legal Authority: 

PL 111–240, sec 1311, 1331 

CFR Citation: 

13 CFR 124 to 127, 134 

Legal Deadline: 

Final, Statutory, September 27, 2011, 

SBA, with Office of Federal 

Procurement Policy, must issue 

guidance by September 27, 2011 under 

section 1331. 

Abstract: 

The U.S. Small Business 

Administration (SBA) is proposing 

regulations that will establish guidance 

under which Federal agencies may set 

aside part of a multiple award contract 

for small business concerns, set aside 

orders placed against multiple award 

contracts for small business concerns 

and reserve one or more awards for 

small business concerns under full and 

open competition for a multiple award 

contract. These regulations will apply 

to small businesses, including those 

small businesses eligible for SBA’s 

socio-economic programs. 

Statement of Need: 

The law recognizes that many small 

businesses were losing Federal contract 

opportunities when agencies issue 

multiple award contracts. This will 

improve small business participation in 

the acquisition process and provide 

clear direction to contracting officers by 

authorizing small business set asides in 

multiple-award contracts. 

Summary of Legal Basis: 

The Small Business Jobs Act of 2010, 

Public Law No. 111-240, section 1331, 

requires the SBA to issue regulations 

implementing this provision within one 

year from the date of enactment. 

Alternatives: 

SBA has not yet determined the costs 

resulting from this regulation. 

Anticipated Cost and Benefits: 

This provision will allow small 

businesses to gain access to multiple 

award contracts through prime contract 

awards or through set asides of the 

orders of the prime contracts. This 

should increase opportunities for small 

businesses. 

Risks: 

Not applicable. 

Timetable: 

Action Date FR Cite 

NPRM 01/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

Federal 

Agency Contact: 

Dean R. Koppel 

Assistant Director, Office of Policy and 

Research 

Small Business Administration 

409 Third Street SW 

Washington, DC 20416 

Phone: 202 205–7322 

Fax: 202 481–1540 

Email: dean.koppel@sba.gov 

RIN: 3245–AG20 


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SBA 

FINAL RULE STAGE 

161. SMALL BUSINESS SIZE 

REGULATIONS; (8)A BUSINESS 

DEVELOPMENT/SMALL 

DISADVANTAGED BUSINESS STATUS 

DETERMINATION 

Priority: 

Other Significant 

Legal Authority: 

15 USC 634(b)(6), 636(j), 637(a) and (d) 

CFR Citation: 

13 CFR 124 

Legal Deadline: 

None 

Abstract: 

This rule proposes to make a number 

of changes to the regulations governing 

the 8(a) Business Development (8(a) 

BD) Program and several changes to 

SBA’s size regulations. Some of the 

changes involve technical issues, such 

as changing the term ‘‘SIC code’’ to 

‘‘NAICS code’’ to reflect the national 

conversion to the North American 

Industry Classification System. SBA has 

learned through experience that certain 

of its rules governing the 8(a) BD 

program are too restrictive and serve 

to unfairly preclude firms from being 

admitted to the program. In other cases, 

SBA has determined that a rule is too 

expansive or indefinite and has sought 

to restrict or clarify that rule. Changes 

are also being proposed to correct past 

public or agency misinterpretation. 

Also, new situations have arisen that 

were not anticipated when the current 

rules were drafted and the proposed 

rule seeks to cover those situations. 

Finally, one of the changes, implements 

statutory changes that impact Native 

Hawaiian Organizations. 

Statement of Need: 

Sections 8(a) and 7(j) of the Small 

Business Act authorize the SBA to 

administer the 8(a) BD program and 

assist eligible small disadvantaged 

business concerns compete in the 

American economy through business 

development. The 8(a) BD program 

provides procurement, financial, 

management and technical assistance to 

foster the business growth and 

development of 8(a) BD program 

participants. The proposed regulatory 

action is necessary to implement 

changes to the regulations governing 

the 8(a) BD program, the Small 

Disadvantaged Business (SDB) 

programs, and to the SBA size 

regulations. The changes are proposed 

as a result of the continuing need to 

ensure that SBA is effectively 

delivering the 8(a) BD program in 

accordance with the Small Business 

Act. In addition, the regulatory action 

is needed to enable SBA to institute 

the proper internal controls that will 

ensure effective monitoring and 

oversight of the 8(a) BD Program. 

Summary of Legal Basis: 

This rule proposes to make some 

changes that involve technical issues, 

correct some rules governing the 8(a) 

BD program that are too restrictive, and 

others that require clarification. The 

rule change will address new situations 

that have arisen that were not 

anticipated when the current rules were 

drafted. Finally, there is one change 

that implements a statutory change. 

Alternatives: 

SBA will analyze and consider the 

impact of any comments received from 

the public as a result of the proposed 

regulations being published in the 

Federal Register. Where relevant and 

appropriate, the regulations will be 

revised to incorporate these comments. 

Anticipated Cost and Benefits: 

It is difficult to estimate the costs and 

benefits to the various classes of firms 

affected by this rule as it is impossible 

to foresee which future contracts above 

the competitive thresholds would be 

awarded based on the various options 

available to contracting officers. SBA 

believes that the benefits of the 

proposed rule exceed its costs and 

exceed the benefits of continuing the 

status quo. SBA believes that increased 

clarity and easing of restrictions in the 

overall proposed changes set forth in 

this rule are beneficial to 8(a) 

applicants and Participants. 

Risks: 

Because the 8(a) Program is a business 

development program—not a 

contracting program—it is intended to 

foster the 8(a) firm’s growth (through 

various forms of technical, 

management, procurement and 

financial assistance) and viability 

during the Participant’s 9-year term. 

The regulatory action is intended to 

mitigate any risks associated with 

program procedures and internal 

controls by ensuring clear and concise 

regulations. 

Timetable: 

Action Date FR Cite 

NPRM 10/28/09 74 FR 55694 

NPRM Comment 

Period End 

12/28/09 

NPRM Comment 

Period Extended 

12/09/09 74 FR 65040 

Hearing; Tribal 

Consultation 

12/07/09 74 FR 64026 

Hearing 12/14/09 74 FR 66176 

Hearing 01/11/10 75 FR 1296 

NPRM Comment 

Period End 

01/28/10 

Final Action 02/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses, Governmental Jurisdictions 

Government Levels Affected: 

None 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

LeAnn Delaney 

Deputy Director, Office of Business 

Development 

Small Business Administration 

409 3rd St SW 

Washington , DC 20416 

Phone: 202 205–6731 

Email: leann.delaney@sba.gov 

RIN: 3245–AF53 

SBA 

162. ∑ SMALL BUSINESS JOBS ACT: 

504 LOAN PROGRAM DEBT 

REFINANCING 

Priority: 

Other Significant 

Legal Authority: 

Pub L 111–240, sec 1122 

CFR Citation: 

13 CFR 120, subpart H 

Legal Deadline: 

Final, Statutory, September 27, 2012, 

Authority for program is repealed 2 

years after date of enactment of Small 

Business Jobs Act of 2010. 

Abstract: 

The Small Business Jobs Act directs 

SBA to conduct a two-year program of 

debt refinancing in the 504 loan 

program. The rule sets forth the 

procedures for the refinancing of 

qualified debt and other statutory 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79686 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

requirements. The rule also conforms 

the job creation and retention goals of 

the 504 program to the Act. 

Statement of Need: 

Small businesses continue to struggle 

to gain access to the capital that would 

enable them to continue to pay their 

employees, pay vendors or expand their 

operations. The Jobs Act authorizes 

several financing options that are 

designed to strengthen the capacity of 

these small businesses to obtain the 

funds they need to create jobs and 

stimulate economic growth. Section 

1122 of the Small Business Jobs Act 

is one such option that SBA is required 

to implement as soon as practicable in 

order to maximize the authority which 

expires on September 27, 2012. 

Summary of Legal Basis: 

Section 5(a)(6) of the Small Business 

Act authorizes SBA’s Administrator to 

make such rules and regulations as 

deemed necessary to carry out any 

authorities vested in the Administrator. 

Alternatives: 

SBA currently has regulations 

governing debt refinancing. Regulations 

are necessary in order to conform those 

existing regulations to the additional 

debt refinancing authority provide by 

the Jobs Act. 

Anticipated Cost and Benefits: 

At this time SBA has not yet estimated 

the costs or benefits that may result 

from this rulemaking. 

Risks: 

Not Yet Determined 

Timetable: 

Action Date FR Cite 

Interim Final Rule 02/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Andrew B. McConnell Jr. 

Chief, 504 Loan Program, Office of 

Financial Assistance 

Small Business Administration 

409 Third Street, SW 

Washington, DC 20416 

Phone: 202 205–7238 

Email: andrew.mcconnell@sba.gov 

RIN: 3245–AG17 

SBA 

163. ∑ SMALL BUSINESS JOBS ACT: 

SMALL BUSINESS INTERMEDIARY 

LENDING PILOT PROGRAM 

Priority: 

Other Significant 

Legal Authority: 

PL 111–240, sec 1131 

CFR Citation: 

13 CFR 120, subpart L 

Legal Deadline: 

Final, Statutory, March 26, 2011, sec 

1131(b) of the Jobs Act requires SBA 

to issue implementing regulations no 

later than March 26, 2011. 

Abstract: 

The Small Business Jobs Act directs 

SBA to conduct a 3-year Small 

Business Intermediary Lending Pilot 

Program. SBA will provide loans to 

eligible intermediaries for the purpose 

of making loans to start-up, newly 

established, and growing small business 

concerns. The rule implements the 

statute and sets the terms and 

conditions of the loans made under the 

Program. 

Statement of Need: 

Due to higher underwriting 

requirements and resource constraints 

faced by banks, small business 

borrowers face significant gaps in the 

credit market. As a result of these gaps, 

more small business borrowers are 

turning to nonprofit lending 

intermediaries to provide low-cost 

alternatives to traditional bank 

financing. These nonprofit lending 

intermediaries have experience offering 

the financial products and services that 

banks, for various reasons, are unable 

or unwilling to offer. The ILPP will 

help to fill these credit gaps by 

providing very low interest loans to 

selected intermediaries. The 

intermediaries will then use the money 

to make loans to small businesses that 

have needs exceeding the limits of 

SBA’s Microloan program but cannot 

obtain financing through a conventional 

lender, even with a 7(a) guaranty. 

Summary of Legal Basis: 

Section 1131(b) of the Jobs Act requires 

SBA to issue regulations no later than 

March 26, 2011, in order to implement 

the intermediary lending pilot program. 

Alternatives: 

Because the Jobs Act requires SBA to 

issue regulations, the Agency cannot 

consider other alternatives ways to 

carry out the lending program pilot 

authority. 

Anticipated Cost and Benefits: 

SBA has not yet analyzed the costs and 

benefits resulting from the 

implementation of the intermediary 

lending pilot program. 

Risks: 

Yet to be determined. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 02/00/11 

Regulatory Flexibility Analysis 

Required: 

Yes 

Small Entities Affected: 

Businesses 

Government Levels Affected: 

None 

Agency Contact: 

Grady Hedgespeth 

Director, Office of Financial Assistance 

Small Business Administration 

409 Third Street SW 

Washington, DC 20416 

Phone: 202 205–7562 

Fax: 202 481–0248 

Email: grady.hedgespeth@sba.gov. 

RIN: 3245–AG18 

BILLING CODE 8025–01–S 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79687 

SOCIAL SECURITY ADMINISTRATION 

(SSA) 

Statement of Regulatory Priorities 

We administer the Retirement, 

Survivors, and Disability Insurance 

programs under title II of the Social 

Security Act (Act), the Supplemental 

Security Income (SSI) program under 

title XVI of the Act, and the Special 

Veterans Benefits program under title 

VIII of the Act. As directed by Congress, 

we also assist in administering portions 

of the Medicare program under title 

XVII of the Act. Our regulations codify 

the requirements for eligibility and 

entitlement to benefits and our 

procedures for administering these 

programs. Generally, our regulations do 

not impose burdens on the private 

sector or on State or local governments, 

except for the States’ disability 

determination services. 

The eight entries in our regulatory 

plan (plan) represent issues of major 

importance to the Agency. We describe 

the individual initiatives more fully in 

the attached plan. 

Improving the Disability Process 

Because the continued improvement 

of the disability program is of vital 

concern to us, we have eight initiatives 

in the plan addressing disability-related 

issues. They include: 

• A proposed rule providing that we 

identify claimants with serious 

medical conditions as soon as 

possible, allowing us to grant benefits 

expeditiously to those claimants who 

meet Social Security disability 

standards; 

• A proposed rule reestablishing 

Uniform National Disability 

Adjudication provisions in our Boston 

Region; 

• Four proposed rules updating the 

medical listings used to determine 

disability—evaluating respiratory 

system disorders, mental disorders, 

hematological disorders, and 

endocrine disorders. The revisions 

reflect our adjudicative experience, 

advances in medical knowledge, 

diagnosis, and treatment. 

Enhance Public Service 

• We are proposing to revise our rules 

to establish a 12-month time limit for 

the withdrawal of an old-age benefits 

application. The proposed rule would 

permit only one withdrawal per 

lifetime. 

• We will prepare a final rule to clarify 

and revise what we consider major 

life-changing events for the Medicare 

Part B income-related, monthly 

adjustment and what evidence we 

require to support a claim of a major 

life-changing event. 

SSA 

PROPOSED RULE STAGE 

164. REVISED MEDICAL CRITERIA 

FOR EVALUATING RESPIRATORY 

SYSTEM DISORDERS (859P) 

Priority: 

Other Significant. Major under 5 USC 

801. 

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 423; 42 USC 902(a)(5); 

42 USC 1381a; 42 USC 1382c; 42 USC 

1383; 42 USC 1383b 

CFR Citation: 

20 CFR 404.1500, app 1 

Legal Deadline: 

None 

Abstract: 

Sections 3.00 and 103.00, Respiratory 

System, of appendix 1 to subpart P of 

part 404 of our regulations describe 

respiratory system disorders that are 

considered severe enough to prevent an 

individual from doing any gainful 

activity or that cause marked and 

severe functional limitations for a child 

claiming SSI payments under title XVI. 

We are proposing to 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. 

Statement of Need: 

These proposed regulations are 

necessary to update the Respiratory 

System listings to reflect advances in 

medical knowledge, treatment, and 

methods of evaluating respiratory 

disorders. The changes would 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 

and 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 respiratory diseases and 

because of our adjudicative experience. 

Anticipated Cost and Benefits: 

Estimated costs—low. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

ANPRM 04/13/05 70 FR 19358 

ANPRM Comment 

Period End 

06/13/05 

NPRM 02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Cheryl A. Williams 

Director 

Social Security Administration 

Office of Medical Listings Improvement 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 965–1020 

Joshua B. Silverman 

Social Insurance Specialist, Regulations 

Writer 

Social Security Administration 

Office of Regulations 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 594–2128 

RIN: 0960–AF58 

SSA 

165. REVISED MEDICAL CRITERIA 

FOR EVALUATING HEMATOLOGICAL 

DISORDERS (974P) 

Priority: 

Other Significant 

Legal Authority: 

42 USC 402; 42 USC 405(a); 42 USC 

405(b); 42 USC 405(d) to 405(h); 42 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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USC 416(i); 42 USC 421(a); 42 USC 

421(i); 42 USC 423; 42 USC 902(a)5); 

42 USC 1381a; 42 USC 1382c; 42 USC 

1383; 42 USC 1383b 

CFR Citation: 

20 CFR 404.1500, app 1 

Legal Deadline: 

None 

Abstract: 

Sections 7.00 and 107.00, 

Hematological Disorders, of appendix 1 

to subpart P of part 404 of our 

regulations, describe hematological 

disorders that are considered severe 

enough to prevent a person from 

performing any gainful activity or that 

cause marked and severe functional 

limitation for a child claiming SSI 

payments under title XVI. We are 

proposing to revise the criteria in these 

sections to ensure that the medical 

evaluation criteria are up-to-date and 

consistent with the latest advances in 

medical knowledge and treatment. 

Statement of Need: 

These proposed regulations are 

necessary to update the hematological 

listings to reflect advances in medical 

knowledge, treatment, and methods of 

evaluating hematological disorders. The 

changes 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 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. 

Anticipated Cost and Benefits: 

Estimated savings - low. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 03/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Cheryl A. Williams 

Director 

Social Security Administration 

Office of Medical Listings Improvement 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 965–1020 

Helen Droddy 

Social Insurance Specialist, Regulations 

Writer 

Social Security Administration 

Office of Regulations 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 965–1483 

RIN: 0960–AF88 

SSA 

FINAL RULE STAGE 

166. REVISED MEDICAL CRITERIA 

FOR EVALUATING ENDOCRINE 

SYSTEM DISORDERS (436P) 

Priority: 

Other Significant 

Legal Authority: 

42 USC 402; 42 USC 405(a); 42 USC 

405(b); 42 USC 405(d) to 405(h); 42 

USC 416(i); 42 USC 421(a); 42 USC 

421(i); 42 USC 423; 42 USC 902(a)(5); 

42 USC 1381a; 42 USC 1382c; 42 USC 

1383; 42 USC 1383b 

CFR Citation: 

20 CFR 404.1500, app 1 

Legal Deadline: 

None 

Abstract: 

Sections 9.00 and 109.00, Endocrine 

System, of appendix 1 to subpart P of 

part 404 of our regulations describe 

endocrine system disorders that are 

considered severe enough to prevent an 

individual from doing any gainful 

activity, or that cause marked and 

severe functional limitations for a child 

claiming SSI payments under title XVI. 

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. 

Statement of Need: 

We are revising the listings for 

endocrine disorders because, since we 

last published final rules making 

comprehensive revisions to the 

endocrine listings in 1985, medical 

science has made significant advances 

in detecting endocrine disorders at 

earlier stages, and new treatments have 

resulted in better management of these 

conditions. Consequently, most 

endocrine disorders do not reach 

listing-level severity because they do 

not become sufficiently severe or do 

not remain at a sufficient level of 

severity long enough to meet our 12- 

month duration requirement. For 

persons whose endocrine disorders are 

not controlled, we make individualized 

determinations about disability. We 

have determined that, with the 

exception of children under age 6 who 

have diabetes mellitus (DM) and 

require daily insulin, we should no 

longer have listings in section 9.00 and 

109.00 based on endocrine disorders 

alone. 

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 continuing to use our 

current criteria. However, we believe 

that finalizing these revisions is 

preferable because of the medical 

advances that have been made in 

treating and evaluating these types of 

disorders. 

Anticipated Cost and Benefits: 

Not yet determined. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

ANPRM 08/11/05 70 FR 46792 

ANPRM Comment 

Period End 

10/11/05 

NPRM 12/14/09 74 FR 66069 

NPRM Comment 

Period End 

02/12/10 

Final Action 01/00/11 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79689 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Cheryl A. Williams 

Director 

Social Security Administration 

Office of Medical Listings Improvement 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 965–1020 

Brian Rudick 

Social Insurance Specialist, Regulations 

Writer 

Social Security Administration 

Office of Regulations 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 965–7102 

RIN: 0960–AD78 

SSA 

167. REVISED MEDICAL CRITERIA 

FOR EVALUATING MENTAL 

DISORDERS (886P) 

Priority: 

Other Significant 

Legal Authority: 

42 USC 402; 42 USC 405(a); 42 USC 

405(b); 42 USC 405(d) to 42 USC 

405(h); 42 USC 416(i); 42 USC 421(a); 

42 USC 421(h); 42 USC 421(i); 42 USC 

423; 42 USC 902(a)(5); 42 USC 1381a; 

42 USC 1382c; 42 USC 1383; 42 USC 

1383b 

CFR Citation: 

20 CFR 404.1500, app 1; 20 CFR 

404.1520a; 20 CFR 416.920a; 20 CFR 

416.934 

Legal Deadline: 

None 

Abstract: 

Sections 12.00 and 112.00, Mental 

Disorders, of appendix 1 to subpart P 

of part 404 of our regulations describe 

those mental impairments that are 

considered severe enough to prevent a 

person from doing any gainful activity, 

or that cause marked and severe 

functional limitations for a child 

claiming SSI payments under title XVI. 

We are proposing to revise the criteria 

in these sections to ensure that the 

medical evaluation criteria are up-todate and consistent with the latest 

advances in medical knowledge and 

treatment. 

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 disorders. 

The changes will 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. 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 disorders. 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-ofthe-art medical knowledge and 

technology. 

Anticipated Cost and Benefits: 

Savings estimates for fiscal years 2010 

to 2018: (in millions of dollars) OASDI315, SSI-370. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

ANPRM 03/17/03 68 FR 12639 

ANPRM Comment 

Period End 

06/16/03 

NPRM 08/19/10 75 FR 51336 

NPRM Comment 

Period End 

11/17/10 

Final Action 07/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Cheryl A. Williams 

Director 

Social Security Administration 

Office of Medical Listings Improvement 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 965–1020 

Fran O. Thomas 

Social Insurance Specialist, Regulations 

Writer 

Social Security Administration 

Office of Regulations 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 966–9822 

RIN: 0960–AF69 

SSA 

168. REESTABLISHING UNIFORM 

NATIONAL DISABILITY 

ADJUDICATION PROVISIONS (3502F) 

Priority: 

Other Significant 

Legal Authority: 

30 USC 923(b); 42 USC 401(j); 42 USC 

402; 42 USC 404(f); 42 USC 405; 42 

USC 405(a); 42 USC 405(b); 42 USC 

405(d) to 405(h); 42 USC 405(j); 42 USC 

405(s); 42 USC 405 note; 42 USC 416(i); 

42 USC 421; 42 USC 421(a); 42 USC 

421(i); 42 USC 421(m); 42 USC 421 

note; 42 USC 422(c); 42 USC 423; 42 

USC 423(i); 42 USC 423 note; 42 USC 

425; 42 USC 432; 42 USC 902(a)(5); 42 

USC 902 note; 42 USC 1320b–1; 42 

USC 1320b–13; 42 USC 1381; 42 USC 

1381a; 42 USC 1382; 42 USC 1382c; 

42 USC 1382h; 42 USC 1382h note; 42 

USC 1383; 42 USC 1383(a); 42 USC 

1383(c); 42 USC 1383(d)(1); 42 USC 

1383(p); 42 USC 1383b 

CFR Citation: 

20 CFR 404.906; 20 CFR 404.930; 20 

CFR 404.1502; 20 CFR 404.1512; 20 

CFR 404.1513; 20 CFR 404.1519k; 20 

CFR 404.1519m; 20 CFR 404.1519s; 20 

CFR 404.1520a; 20 CFR 404.1526; 20 

CFR 404.1527; 20 CFR 404.1529; 20 

CFR 404.1546; 20 CFR 404.1601; 20 

CFR 404.1616; 20 CFR 404.1624; 20 

CFR 405; 20 CFR 416.902; 20 CFR 

416.912; 20 CFR 416.913; 20 CFR 

416.919k; 20 CFR 416.919m; 20 CFR 

416.919s; 20 CFR 416.920a; 20 CFR 

416.924; 20 CFR 416.926; 20 CFR 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
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416.926a; 20 CFR 416.927; 20 CFR 

416.929; 20 CFR 416.946; 20 CFR 

416.1001; 20 CFR 416.1016; 20 CFR 

416.1024; 20 CFR 416.1406; 20 CFR 

416.1430; 20 CFR 422.130; 20 CFR 

422.140; 20 CFR 422.201 

Legal Deadline: 

None 

Abstract: 

We are eliminating the remaining 

portions of part 405 of our rules, which 

we now use for initial disability claims 

in our Boston region. We will use the 

same rules for disability claims in the 

Boston region that we use for disability 

adjudications in the rest of the country, 

including those rules that apply to the 

administrative law judge (ALJ) and 

Appeals Council (AC) levels of our 

administrative review process in parts 

404 and 416 of our rules. 

Statement of Need: 

To provide more consistent processing 

of appeals level claims for all regions. 

Summary of Legal Basis: 

Administrative—not required by statute 

or court order. 

Alternatives: 

Continue existing process. 

Anticipated Cost and Benefits: 

Cost estimates for fiscal year 2009 to 

2018: (in millions of dollars) OASDI55, SSI-7. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

NPRM 12/04/09 74 FR 63688 

NPRM Comment 

Period End 

02/02/10 

Final Action 02/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

None 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Kelly Salzmann 

Attorney Adviser 

Social Security Administration 

Office of Disability Adjudication and 

Review 

5107 Leesburg Pike 

Falls Church, VA 22041–3260 

Phone: 703 605–7100 

Joshua B. Silverman 

Social Insurance Specialist, Regulations 

Writer 

Social Security Administration 

Office of Regulations 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 594–2128 

RIN: 0960–AG80 

SSA 

169. AMENDMENTS TO 

REGULATIONS REGARDING MAJOR 

LIFE–CHANGING EVENTS AFFECTING 

INCOME–RELATED MONTHLY 

ADJUSTMENTS AMOUNTS TO 

MEDICARE PART B PREMIUMS 

(3574F) 

Priority: 

Other Significant 

Legal Authority: 

42 USC 902(a)(5); 42 USC 1395r(i) 

CFR Citation: 

20 CFR 418.1205; 20 CFR 418.1210; 20 

CFR 418.1230; 20 CFR 418.1255; 20 

CFR 418.1265 

Legal Deadline: 

None 

Abstract: 

We are modifying our regulations in 

order to clarify and expand events 

considered life-changing events for the 

purposes of Medicare Part B incomerelated monthly adjustments as well as 

the types of evidence required to 

support claims of such events. 

Statement of Need: 

We are modifying our regulations to 

clarify and revise what we consider 

major life-changing events for the 

Medicare Part B income-related 

monthly adjustment amount (IRMA) 

and what evidence we require to 

support a claim of a major life-changing 

event. Recent changes in the economy 

and other unforeseen events have had 

a significant effect on many Medicare 

Part B beneficiaries. These changes we 

are making in this final rule will allow 

us to respond appropriately to 

circumstances brought about by the 

current economic climate and these 

other unforeseen events. 

Summary of Legal Basis: 

Discretionary. Not required by statute 

or court order. 

Alternatives: 

None. 

Anticipated Cost and Benefits: 

Not yet determined. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 07/15/10 75 FR 41084 

Interim Final Rule 

Comment Period 

End 

09/13/10 

Final Action 03/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

Undetermined 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Craig Streett 

Lead Social Insurance Specialist 

Social Security Administration 

Office of Income Security Programs 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 965–9793 

Helen Droddy 

Social Insurance Specialist, Regulations 

Writer 

Social Security Administration 

Office of Regulations 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 965–1483 

RIN: 0960–AH06 

SSA 

170. AMENDMENTS TO 

REGULATIONS REGARDING 

WITHDRAWALS OF APPLICATIONS 

AND VOLUNTARY SUSPENSION OF 

BENEFITS (3573I) 

Priority: 

Other Significant 

Legal Authority: 

42 USC 402; 42 USC 402(i); 42 USC 

402(j); 42 USC 402(o); 42 USC 402(p); 


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42 USC 402(r); 42 USC 403(a); 42 USC 

403(b); 42 USC 405(a); 42 USC 416; 42 

USC 416(i)(2); 42 USC 423; 42 USC 

423(b); 42 USC 425; 42 USC 428(a) to 

428(e); 42 USC 902(a)(5) 

CFR Citation: 

20 CFR 404.313; 20 CFR 404.640 

Legal Deadline: 

None 

Abstract: 

We propose to modify our regulations 

to establish a 12-month time limit for 

the withdrawal of an old age benefits 

application. We also propose to permit 

only one withdrawal per lifetime. 

These proposed changes would limit 

the voluntary suspension of benefits 

only to those benefits disbursed in 

future months. 

Statement of Need: 

This rule will allow us to establish a 

12-month time limit for the withdrawal 

of an old age benefits application. 

Summary of Legal Basis: 

Discretionary 

Alternatives: 

None. 

Anticipated Cost and Benefits: 

Not yet determined. 

Risks: 

None. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 01/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Small Entities Affected: 

No 

Government Levels Affected: 

Undetermined 

Agency Contact: 

Helen Droddy 

Social Insurance Specialist, Regulations 

Writer 

Social Security Administration 

Office of Regulations 

6401 Security Boulevard 

Baltimore, MD 21235–6401 

Phone: 410 965–1483 

Deidre Bemister 

Social Insurance Specialist 

Social Security Administration 

Office of Information Security Programs 

Baltimore, MD 21235–6401 

Phone: 410 966–6223 

RIN: 0960–AH07 

BILLING CODE 4191–02–S 


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79692 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

CONSUMER FINANCIAL PROTECTION 

BUREAU (CFPB) 

Statement of Regulatory Priorities 

The Consumer Financial Protection 

Bureau is in a stand-up phase as it 

prepares to accept functions transferring 

from seven other Federal agencies on 

July 21, 2011, and employees from six 

of those agencies on or about the same 

date. The Agency will need to 

promulgate various housekeeping rules 

governing such topics as administrative 

procedures, data security and privacy 

protections, and enforcement 

procedures as part of the stand-up 

process. 

With regard to substantive rules under 

Federal consumer financial laws that 

transfer to the CFPB’s jurisdiction or 

become effective on July 21, 2011, much 

of the CFPB’s immediate focus will be 

on implementing mandatory 

rulemakings under the Dodd-Frank Act 

concerning mortgages, remittances, and 

data reporting on consumer financial 

services. Other agencies such as the 

Federal Reserve Board may begin 

developing rules on some of these topics 

prior to the July 21 transfer date, at 

which time the CFPB will become 

responsible for completing Dodd-Frank 

Act mandates in accordance with 

statutory deadlines. 

BILLING CODE 4810–25–S 


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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: 

• Develops mandatory product safety 

standards or banning rules when 

other, less restrictive, efforts are 

inadequate to address a safety hazard, 

or where required by statute; 

• Obtains repair, replacement, or refund 

of the purchase price for defective 

products that present a substantial 

product hazard; 

• Develops information and education 

campaigns about the safety of 

consumer products; 

• Participates in the development or 

revision of voluntary product safety 

standards; and 

• Follows congressional mandates to 

enact specific regulations. 

When deciding which of these 

approaches to take in any specific case, 

the Commission gathers and analyzes 

the best available data about the nature 

and extent of the risk presented by the 

product. 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; and 

• Probability of exposure to the hazard. 

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. 

Additionally, the Consumer Product 

Safety Improvement Act of 2008 

(CPSIA), Public Law 110-314 (Aug. 14, 

2008), requires numerous rules and 

notices to be completed on a specific 

schedule. One such regulatory action 

pertains to the testing, certification, and 

labeling of certain consumer products. 

Section 102(d)(2) of the CPSIA requires 

the Commission to initiate by 

regulation: (1) A program by which a 

manufacturer or private labeler may 

label a consumer product as complying 

with the certification requirements of 

section 102(a) of the CPSIA; (2) 

protocols and standards (i) for ensuring 

that a children’s product tested for 

compliance with an applicable 

children’s product safety rule is subject 

to testing periodically and when there 

has been a material change in the 

product’s design or manufacturing 

process, including the sourcing of 

component parts; (ii) for the testing of 

random samples to ensure continued 

compliance; (iii) for verifying that a 

children’s product tested by a 

conformity assessment body complies 

with applicable children’s product 

safety rules; and (iv) for safeguarding 

against the exercise of undue influence 

on a third-party conformity assessment 

body by a manufacturer or private 

labeler. This regulatory action will 

constitute a ‘‘significant regulatory 

action’’ under the definition in 

Executive Order 12866 ‘‘Regulatory 

Planning and Review’’ (Oct. 4, 1993). 

CPSC 

FINAL RULE STAGE 

171. TESTING, CERTIFICATION, AND 

LABELING OF CERTAIN CONSUMER 

PRODUCTS 

Priority: 

Economically Significant. Major under 

5 USC 801. 

Legal Authority: 

PL 110–314, sec 102 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

NPRM, Statutory, November 14, 2009. 

Abstract: 

Section 102(b) of the Consumer Product 

Safety Improvement Act of 2008 

(CPSIA), Public Law 110-314 (Aug. 14, 

2008), requires the Commission to 

initiate by regulation, no later than 15 

months after the date of enactment: (1) 

A program by which a manufacturer or 

private labeler may label a consumer 

product as complying with the 

certification requirements of section 

102(a) of the CPSIA; (2) protocols and 

standards (i) for ensuring that a 

children’s product tested for 

compliance with an applicable 

children’s product safety rule is subject 

to testing periodically and when there 

has been a material change in the 

product’s design or manufacturing 

process, including the sourcing of 

component parts; (ii) for the testing of 

random samples to ensure continued 

compliance; (iii) for verifying that a 

children’s product tested by a 

conformity assessment body complies 

with applicable children’s product 

safety rules; and (iv) for safeguarding 

against the exercise of undue influence 

on a third-party conformity assessment 

body by a manufacturer or private 

labeler. In May 2010, the Commission 

published a Notice of Proposed 

Rulemaking (NPRM) in the Federal 

Register. The proposed rule defined a 

reasonable testing program for nonchildren’s products subject to a rule, 

ban, standard, or regulation enforced by 

the Commission and additional thirdparty testing requirement for children’s 

products. 

Statement of Need: 

Section 102(d) of the Consumer Product 

Safety Improvement Act of 2008 

(CPSIA) requires the Consumer Product 

Safety Commission (CPSC) to engage in 

rulemaking to establish requirements 

pertaining to the testing, certification, 

and labeling of certain consumer 

products. CPSC also has elected to 

issue regulations regarding a 

‘‘reasonable testing program’’ under 

section 102(a) of the CPSIA to establish 

the elements of such a program. 

Summary of Legal Basis: 

Section 102(b) of the CPSIA requires 

the Commission to initiate by 

regulation: (1) A program by which a 

manufacturer or private labeler may 

label a consumer product as complying 

with the certification requirements of 

section 102(a) of the CPSIA; (2) 

protocols and standards (i) for ensuring 

that a children’s product tested for 

compliance with an applicable 

children’s product safety rule is subject 

to testing periodically and when there 

has been a material change in the 

product’s design or manufacturing 

process, including the sourcing of 

component parts; (ii) for the testing of 

random samples to ensure continued 

compliance; (iii) for verifying that a 

children’s product tested by a 

conformity assessment body complies 

with applicable children’s product 

safety rules; and (iv) for safeguarding 

against the exercise of undue influence 

on a third-party conformity assessment 

body by a manufacturer or private 

labeler. 


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79694 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

Section 102(a) of the CPSIA requires 

manufacturers of certain products to 

certify, based on a test of each product 

or upon a reasonable testing program, 

that such product comports with all 

rules, bans, standards, or regulations 

applicable to the product under laws 

enforced by CPSC. Section 3 of the 

CPSIA authorizes the Commission to 

issue regulations, as necessary, to 

implement the CPSIA and the 

amendments made by the CPSIA. 

Alternatives: 

The preamble to the proposed rule 

invited comment on alternatives such 

as: (1) Establishing different compliance 

or reporting requirements that take into 

account the resources available to small 

businesses; (2) clarifying, consolidating, 

or simplifying compliance and 

reporting requirements for small 

entities; (3) using performance rather 

than design standards; and (4) 

exempting small entities to the extent 

statutorily permissible under section 14 

of the CPSA. However, the proposal 

would give firms considerable 

discretion to determine the precise 

nature of their testing programs 

(including the number of samples to be 

tested and testing frequency). As for 

exemptions, the statute does not appear 

to give the Commission the authority 

to exempt firms from the testing or 

certification requirements, so it may not 

be possible to exempt firms within 

section 14 of the CPSA. 

Anticipated Cost and Benefits: 

The congressional mandate to issue this 

regulation does not require the 

Consumer Product Safety Commission 

to do a cost/benefit analysis for this 

regulation. Therefore, a cost/benefit 

analysis is not available for this 

regulatory action. 

Risks: 

Congress determined a need for testing, 

and in the case of children’s products, 

third-party testing to ensure compliance 

with the Agency’s standards. The 

Agency’s standards address 

unreasonable risks of injury associated 

with consumer products; testing and 

certification to these standards provide 

an extra assurance that the consumer 

products are free from those 

unreasonable risks of injury; and 

through such testing programs, 

encourage manufacturers to address 

possible risks in the early stages of 

product manufacture. Given the breadth 

of the risks of injury the Agency’s 

standards address and the number of 

products that are subject to testing or 

third-party testing, it is not possible to 

provide an analysis of the magnitude 

of the risk this regulatory action 

addresses. 

Timetable: 

Action Date FR Cite 

Staff Sends Briefing 

Package to the 

Commission 

04/01/10 

Commission Decision 05/05/10 

NPRM 05/20/10 75 FR 28336 

NPRM Comment 

Period End 

08/03/10 

Staff Sends Briefing 

Package to 

Commission 

01/00/11 

Regulatory Flexibility Analysis 

Required: 

Undetermined 

Government Levels Affected: 

None 

Agency Contact: 

Randy Butturini 

Project Manager 

Consumer Product Safety Commission 

Office of Hazard Identification and 

Reduction 

4330 East West Highway 

Bethesda, MD 20814–4408 

Phone: 301 504–7562 

Email: rbutturini@cpsc.gov 

RIN: 3041–AC71 

BILLING CODE 6355–01–S 


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1For example, the Fair Credit Reporting Act (15 

U.S.C. sections 1681 to 1681(u), as amended) and 

the Gramm-Leach-Bliley Act (Pub. L.106-102, 113 

Stat.1338, codified in relevant part at 15 U.S.C. 

sections 6801 to 6809 and sections 6821 to 6827, 

as amended). 2For example, the Energy Policy Act of 1992 (106 

Stat. 2776, codified in scattered sections of the U.S. 

Code, particularly 42 U.S.C. section 6201 et seq. 

and the Energy Independence and Security Act of 

2007 (EISA). 3The FTC also prepares a number of annual and 

periodic reports on the statutes it administers. 

These are not discussed in this plan. 4This report can be found at 

http://www.ftc.gov/os/2010/01/ 

100112payfordelayrpt.pdf. 

5Go to Final Actions and see Debt Relief Services 

TSR Rule. 6Go to Rulemakings and Studies Required by 

Statute and see Mortgage Loans Rule. 7This can be found at 

http://www.ftc.gov/bcp/workshops/debtcollection/ 

dcwr.pdf. 

FEDERAL TRADE COMMISSION (FTC) 

Statement of Regulatory Priorities 

I.Regulatory Priorities 

Background 

The Federal Trade Commission 

(‘‘FTC’’ or ‘‘Commission’’) is an 

independent agency charged by its 

enabling statute, the Federal Trade 

Commission Act, 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 competition, based on 

truthful and non-misleading 

information about products and 

services, brings the best choice of 

products and services at the lowest 

prices for consumers. 

The Commission pursues its goal of 

promoting competition in the 

marketplace through two different, but 

complementary, approaches. Unfair or 

deceptive acts or practices 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. In addition, the Commission is 

also charged with the responsibility of 

issuing and enforcing regulations under 

a number of statutes. Most notably, 

pursuant to the FTC Act, the 

Commission currently has in place 16 

trade regulation rules. Other examples 

include the regulations enforced 

pursuant to credit and financial 

statutes1 and to energy laws.2 The 

Commission also has adopted a number 

of voluntary industry guides. Most of 

the regulations and guides pertain to 

consumer protection matters and are 

intended to ensure that consumers 

receive the information necessary to 

evaluate competing products and make 

informed purchasing decisions. 

Commission Initiatives 

The Commission vigorously protects 

consumers through a variety of tools 

including both regulatory and nonregulatory 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. 

As detailed below, information 

privacy and security, the evolving 

nature of technology, health care, 

consumer credit and finance issues, and 

marketing to children continue to be at 

the forefront of the Commission’s 

consumer protection and competition 

programs. By subject area, we discuss 

the major workshops, reports,3 and 

initiatives the FTC has pursued since 

the 2009 Regulatory Plan was 

published. 

(a)Medical and Health Care. On 

January 13, 2010, FTC staff released a 

report entitled ‘‘Pay-for-Delay: How 

Drug Company Pay-Offs Cost 

Consumers Billions.’’4 The study found 

that settlement deals featuring payments 

by branded drug firms to a generic 

competitor kept generics off the market 

for an average of 17 months longer than 

agreements that do not include a 

payment and cost consumers an 

estimated $3.5 billion per year—or $35 

billion over 10 years. 

In a speech to the American Medical 

Association in June 2010, Chairman Jon 

Leibowitz noted that the new health 

care reform law establishes programs for 

Medicare called ‘‘accountable care 

organizations,’’ or ACOs, as possible 

devices to improve quality and lower 

the cost of health care. On October 5, 

2010, the Commission held a public 

workshop on health care competition 

policy, payment reform, and the new 

models for delivering health care that 

seek to incentivize high-quality, costeffective care. The FTC workshop 

focused on how ACOs could affect 

competition in commercial health care 

markets. 

(b) Assistance to Consumers in 

Financial Distress. Historic levels of 

consumer debt, increased 

unemployment, and an unprecedented 

downturn in the housing and mortgage 

markets have contributed to high rates 

of consumer bankruptcies and mortgage 

loan delinquency and foreclosure. Debt 

relief services have proliferated in 

recent years as the economy has 

declined and greater numbers of 

consumers hold debts they cannot pay. 

During the summer of 2010, the 

Commission issued a final rule 

amending the Telemarketing Sales Rule 

to address the telemarketing of debt 

relief services offered to consumers.5

The amendments are necessary to 

protect consumers from deceptive or 

abusive practices in the telemarketing of 

debt relief services. 

The recent national mortgage crisis 

has launched an industry of companies 

purporting, for a fee, to obtain mortgage 

loan modifications or other relief for 

consumers facing foreclosure. The 

Commission and other law enforcement 

have also taken action against mortgage 

companies that harm consumers 

through their advertising and servicing 

practices. The Commission initiated 

active rulemakings to protect distressed 

homeowners, one relating to Mortgage 

Assistance Relief Services (‘‘MARS’’) 

and another relating to Mortgage Acts 

and Practices (‘‘MAP’’) through the life 

cycle of the mortgage loan.6 The MAP 

proceeding has since been split into 

rulemakings on MAP-Advertising and 

MAP-Servicing. 

In February 2009, the FTC issued 

‘‘Collecting Consumer Debts: The 

Challenges of Change.’’7 The report 

noted that the FTC lacked sufficient 

information on debt collection 

proceedings. In the summer and fall of 

2009, the Commission convened three 

public roundtables at which it examined 

consumer protection issues involving 


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79696 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

8The report is available at 

http://www.ftc.gov/os/2010/07/ 

debtcollectionreport.pdf. 9See 

http://www.ftc.gov/bcp/workshops/ 

privacyroundtables/index.shtml. 

10The report is available at 

http://www.ftc.gov/os/2008/07/ 

P064504foodmktingreport.pdf. 

11The booklet can be accessed at 

http://www.onguardonline.gov/pdf/tec04.pdf. 12The report is available at 

http://www.ftc.gov/os/2010/05/100528cwg-rpt.pdf. 

debt collections, both in litigation and 

arbitration proceedings. 

In July 2010, the Commission issued 

a report entitled ‘‘Repairing a Broken 

System: Protecting Consumers in Debt 

Collection Litigation and Arbitration.’’8

The report concluded that the system 

for resolving consumer debt collection 

disputes is broken and recommended 

significant litigation and arbitration 

reforms to improve efficiency and 

fairness to consumers. The 

Commission’s principal 

recommendations to address these 

concerns in litigation included requiring 

States to adopt measures to make it 

more likely that consumers will defend 

themselves in litigation and taking steps 

to make it less likely that collectors will 

sue on debt on which the statute of 

limitations has run, as well as changing 

Federal and State laws to prevent the 

freezing of a specified amount in a bank 

account including funds exempt from 

garnishment. The report also addresses 

concerns about requiring consumers to 

resolve debt collection disputes through 

binding arbitration without meaningful 

choice, bias, or the appearance of bias 

in arbitration proceedings, and 

procedural unfairness in arbitration 

proceedings. 

(c) Privacy Challenges to Consumers 

Posed by Technology and Business 

Practices. The Commission is exploring 

the privacy challenges posed by 

technological and business practices 

that collect and use consumer data. The 

FTC has held three public roundtables9

at which it considered the following 

issues: 

• On December 7, 2009, the FTC 

focused on the benefits and risks of 

information-sharing practices, 

consumer expectations regarding such 

practices, behavioral advertising, 

information brokers, and the 

adequacy of existing legal and selfregulatory frameworks. 

• The second roundtable on January 28, 

2010, focused on how technology 

affects consumer privacy, including 

its role in both raising privacy 

concerns and enhancing privacy 

protections and included specific 

discussions on cloud computing, 

mobile computing, and social 

networking. 

• On March 17, 2010, a third roundtable 

addressed Internet architecture and 

privacy issues, health and other 

sensitive consumer information, and 

lessons that have been learned from 

the three roundtables and possible 

ways forward. 

The Commission accepted written 

comments and original research in 

connection with all three workshops. 

The Commission expects to release 

recommendations for public comment 

during the latter part of 2010. 

(d) Food Marketing to Children. In 

2008, the FTC issued a report entitled 

‘‘Marketing Food to Children and 

Adolescents: A Review of Industry 

Expenditures, Activities, and SelfRegulation.’’10 As a followup to this 

report, the Commission held a forum on 

December 15, 2009, where participants 

presented new research on the impact of 

various food advertising techniques on 

children, discuss the statutory and 

constitutional issues surrounding 

governmental regulation of food 

marketing, and addressed the food and 

entertainment industries’ self-regulatory 

efforts and implementation of the 

recommendations in the FTC’s 2008 

report. The Commission is also a 

member of an Interagency Working 

Group on Food Marketed to Children, 

composed of members of the FTC, the 

Food and Drug Administration, the 

Centers for Disease Control and 

Prevention, and the Department of 

Agriculture. The working group was 

established in response to a provision in 

the FY 2009 Omnibus Appropriations 

Act (H.R. 1105) and is charged with 

conducting a study and developing 

recommendations for nutritional 

standards for foods marketed to children 

ages 17 and under. During the fall of 

2010, the agencies plan to seek 

comments on proposed nutrition and 

marketing standards. Findings and 

recommendations will be submitted in a 

report to Congress. 

Following receipt of OMB approval 

on July 8, 2010, on August 12, 2010, the 

Commission issued information 

requests to 48 major food and beverage 

manufacturers, distributors, and 

marketers, as well as quick-service 

restaurant companies, about spending 

and marketing activities targeting 

children and adolescents and 

nutritional information for food and 

beverage products that the companies 

market to these consumers. The study 

will advance the Commission’s efforts to 

understand how food industry 

promotional dollars targeted to children 

and adolescents are allocated, the types 

of activities and marketing techniques 

the food industry uses to market its 

products to children and adolescents, 

and the extent to which self-regulatory 

efforts are succeeding in improving the 

nutritional quality of foods advertised to 

children and adolescents. 

(e) Other Children’s Initiatives. On 

December 16, 2009, the Commission, 

along with other Government agencies, 

released a cybersafety booklet, ‘‘Net 

Cetera: Chatting with Kids About Being 

Online.’’11 This publication provides 

information to parents and teachers 

about how to talk to kids about issues 

like cyberbullying, sexting, mobile 

phone safety, and protecting the family 

computer. As of September 12, 2010, the 

Commission had distributed 4.4 million 

copies of the English language version 

and 462,000 copies of the Spanish 

language version of this publication, as 

well as 2.7 million related bookmarks. 

In the fall of 2009, the Commission 

contributed a report to the White House 

Council on Women and Girls.12 The 

report highlights five areas, describing, 

for each, recent FTC law enforcement 

actions or policy initiatives, as well as 

available consumer and business 

education materials. The areas are 

health care for women and children, 

marketing to children and adolescents, 

consumer credit, entrepreneurship and 

business opportunities, and family 

pocketbook issues. 

On April 28, 2010, the Commission 

launched ‘‘Admongo,’’ a campaign to 

raise advertising literacy among the 

Nation’s youth. The campaign is 

targeted to ‘‘tweens’’ aged 8 to 12, and 

includes a game-based website at 

Admongo.gov, a curriculum tied to 

national standards of learning in 

language arts and social studies that 

teachers can use to ‘‘ad-ucate’’ students, 

a library of fictional ads that can be used 

as teaching tools, and activities for 

parents and kids to do together. All 

these materials are free and in the 

public domain. 

Regarding the marketing of violent 

entertainment to children, the 

Commission continues to encourage 

industry groups to improve their selfregulatory programs to discourage the 

marketing to children of movies, games, 

and music that the industries’ rating or 

labeling systems indicate are 

inappropriate for children or warrant 

parental caution due to their violent 


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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79697 

13For the most recent report, see ‘‘Federal Trade 

Commission, Marketing Violent Entertainment to 

Children: A Sixth Follow-Up Review of Industry 

Practices in the Motion Picture, Music Recording 

and Electronic Game Industries a Report to 

Congress’’ (Dec. 2009), available at 

http://www.ftc.gov/os/2009/12/ 

P994511violententertainment.pdf. 14More information can be found at 

http://www.dontserveteens.gov/. 

15The report is available at 

http://www.ftc.gov/os/2009/12/ 

091229fraudstaffreport.pdf. 

16The formal title of the act is the ‘‘Undertaking 

Spam, Spyware, and Fraud Enforcement with 

Enforcers Beyond Borders Act of 2006’’ (Pub. L. No. 

109-455, amending the FTC Act, 15 U.S.C. sections 

41 et seq.). 17This report can be found at 

http://www.ftc.gov/os/2009/12/ 

P035303safewebact2009.pdf. 

content. Since the FTC issued its first 

report on marketing violent 

entertainment to children in 2000, the 

Agency has called on the entertainment 

industry to be more vigilant in three 

areas: Restricting the marketing of 

mature-rated products to children, 

clearly and prominently disclosing 

rating information, and restricting 

children’s access to mature-rated 

products at retail. 

The FTC’s seventh and most recent 

report concluded that marketers of 

violent music, movies, and video games 

can do more to restrict the promotion of 

these products to children.13 This latest 

report found areas for improvement 

among music, movie, and video game 

marketers but credited the game 

industry with outpacing the other two 

industries in all three areas. Since 1999, 

the Commission has issued seven 

reports on these three industries, 

examining the industries’ compliance 

with their own voluntary marketing 

guidelines. 

Regarding advertising for beverage 

alcohol products, the Commission 

issued on September 8, 2010, orders 

requiring three mid-sized suppliers to 

provide information about advertising 

and marketing practices and compliance 

with self-regulatory guidelines. In the 

coming year, the Commission will 

review the three companies’ responses 

and consult with these companies in 

light of the information provided. This 

procedure is consistent with a 2008 

commitment by the Commission to 

conduct small studies of industry selfregulation in years when no major study 

was underway. Further, in early 2011, 

the Commission will begin the process 

of seeking Office of Management and 

Budget approval, under the Paperwork 

Reduction Act, to conduct another 

major study of alcohol marketing and 

self-regulation; that study will evaluate 

the advertising practices of the major 

alcohol suppliers. The Commission will 

also continue to promote the ‘‘We Don’t 

Serve Teens’’ consumer education 

program, supporting the legal drinking 

age.14

(f) Horizontal Merger Guidelines. In 

December 2009 and January 2010, the 

Commission and the Department of 

Justice (DOJ) solicited public comments 

and held five joint public workshops to 

explore the possibility of updating the 

Horizontal Merger Guidelines that are 

used by both agencies to evaluate the 

potential competitive effects of mergers 

and acquisitions. On April 20, 2010, the 

Commission released for public 

comment proposed revisions to the 

guidelines designed to more accurately 

reflect the way the FTC and DOJ 

currently conduct merger reviews. The 

comment period was extended through 

June 4, 2010, at the request of several 

organizations that planned to submit 

comments. 

On August 19, 2010, the two agencies 

issued revised Horizontal Merger 

Guidelines, marking the first major 

revision of the merger guidelines in 18 

years and giving businesses a better 

understanding of how the agencies 

evaluate proposed mergers. A primary 

goal of the 2010 guidelines is to help the 

agencies identify and challenge 

competitively harmful mergers while 

avoiding unnecessary interference with 

mergers that either are competitively 

beneficial or likely will have no 

competitive impact on the marketplace. 

To accomplish this, the guidelines 

detail the techniques and main types of 

evidence the agencies typically use to 

predict whether horizontal mergers may 

substantially lessen competition. The 

updated guidelines are available on the 

FTC’s website at 

http://www.ftc.gov/os/2010/08/ 

100819hmg.pdf and the DOJ’s website at 

http://www.justice.gov/atr/public/ 

guidelines/hmg-2010.html. 

(g) Fraud Forum Report and Surveys. 

The FTC hosted a ‘‘Fraud Forum’’ on 

February 25-26, 2009. The first day was 

open to the public and addressed the 

many aspects of fraud today. The 

second day was open only to domestic 

and international law enforcement 

officials and focused on improving 

interagency coordination in consumer 

fraud cases. In December 2009, the FTC 

staff issued a ‘‘Fraud Forum’’ report.15

The report recommended extending the 

FTC’s outreach to under-served 

communities, improving victim 

assistance, combating fraud by enlisting 

the help of third-parties and targeting 

third-party enablers and facilitators, 

expanding contributors to the FTC’s 

Consumer Sentinel database, and 

making data available to law enforcers. 

Separately, the FTC, through its 

Bureau of Economics, will continue to 

conduct fraud surveys and related 

research on consumer susceptibility to 

fraud. For example, pending approval 

from the Office of Management and 

Budget, the FTC will conduct an 

exploratory study during 2011 on 

consumer susceptibility to fraudulent 

and deceptive marketing. This research 

would be conducted to further the FTC’s 

mission of protecting consumers from 

unfair and deceptive marketing. It is the 

first of two such studies that the FTC 

anticipates conducting. Should the FTC 

pursue the second study, it will seek 

clearance for it at the appropriate later 

time. The study is not intended to lead 

to enforcement actions; rather, study 

results may aid the FTC’s efforts to 

better target its enforcement actions and 

consumer education initiatives, and 

improve future fraud surveys. 

(h) Protecting Consumers from CrossBorder Harm. In December 2009, the 

Commission issued a report examining 

how the Agency has used the expanded 

law enforcement authority Congress 

provided in the U.S. SAFE WEB Act to 

protect American consumers.16 This 

statute authorizes the FTC to share 

information and work cooperatively 

with foreign law enforcement agencies 

to protect consumers from cross-border 

harm. The report ‘‘The U.S. SAFE WEB 

Act: The First Three Years’’17 provides 

data on the number of cross-border 

complaints received by the Commission 

and a description of specific cases in 

which the FTC has worked 

cooperatively with foreign agencies. The 

Commission recommends that Congress 

take action to repeal a ‘‘sunset’’ 

provision that would cause the act to 

expire in 2013. 

On May 6-7, 2010, as part of its 

ongoing effort to combat cross-border 

fraud, the Commission hosted 

counterparts from more than 40 

countries to discuss enforcement 

strategies and emerging consumer 

protection issues. Agenda topics include 

decentralized global scams, electronic 

transactions, emerging trends and risks 

associated with social networking sites, 

and advance-fee fraud. During the 

conference, the FTC and participants in 

the International Consumer Protection 

Enforcement Network launched an 

updated version of the econsumer.gov 

website, a portal for consumers to file 

cross-border complaints and find 


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information about possible ways to 

resolve their complaints. 

(i) Journalism and the Internet. The 

FTC hosted a series of three workshops 

entitled ‘‘From Town Criers to Bloggers: 

How Will Journalism Survive the 

Internet Age?’’ The workshops 

considered the following issues. 

• The December 1-2, 2009, workshop 

broadly considered the economics of 

journalism; the wide variety of new 

business and non-profit models for 

journalism; the financial, 

technological, and other challenges 

facing the news industry; and a 

variety of Government policies, 

including antitrust, copyright, and tax 

policy, bearing on journalism. 

• The second workshop, held on March 

9-10, 2010, addressed proposals by 

workshop participants to better 

support and lower the costs of 

journalism. The topics included 

changes to copyright, tax, and other 

laws; the potential advantages and 

disadvantages of combining the 

interests of for-profit and non-profit 

investors in hybrid entities; efforts to 

make Government data more 

accessible and easily managed in 

ways that may lower the costs of 

journalism; and collaborations that 

news organizations may use to lower 

their costs and better support 

journalism. 

• On June 15, 2010, the FTC held its 

final workshop at which experienced 

journalists, publishers, academics, 

economists, and other policy experts 

compared, contrasted, and evaluated 

the ideas for sustaining journalism 

that have been set forth by 

participants in the previous 

workshops and in a wide variety of 

reports and conferences. In 

connection with the third workshop, 

the FTC staff prepared and posted a 

discussion draft summarizing the 

state of journalism today and setting 

forth the proposals made to date. The 

document was designed to prompt 

discussion of whether to recommend 

policy changes and, if so, which 

specific proposals would be most 

useful, feasible, platform-neutral, 

resistant to bias, and unlikely to cause 

unintended consequences in 

addressing emerging gaps in news 

coverage. 

The Commission has received 

comments in connection with its 

workshops and intends to release a 

report during the fall of 2010. 

(j) Intellectual Property. The 

Commission held a series of five 

hearings on the ‘‘Evolving Intellectual 

Property (IP) Marketplace.’’ The 

hearings generally focused on 

examining changes in intellectual 

property law, patent-related business 

models, and new information regarding 

the operation of the IP marketplace 

since the issuance of the FTC’s October 

2003 report, ‘‘ To Promote Innovation: 

The Proper Balance of Competition and 

Patent Law and Policy.’’ 

• Overview Hearing. On December 5, 

2008, three panels provided an 

overview of developing business 

models, recent and proposed changes 

in IP remedies law, and changes in 

legal doctrines affecting the value and 

licensing of patents. 

• Remedies. On February 11-12, 2009, 

the Commission held hearings on 

damages in patent cases and changes 

in permanent injunction and willful 

infringement standards in the wake of 

recent court decisions. 

• Operation of IP Markets. The hearings 

on March 18-19, 2009, explored how 

different industries use patents, the 

economic and legal perspectives on IP 

and technology markets, and the 

notice role of patents. 

• Markets for Intellectual Property. This 

April 17, 2009, hearing addressed 

new business models in the IP market; 

strategies for buying, selling, and 

licensing patents; and the role of 

secondary markets. 

• Industry Focus. A May 4-5, 2009, 

hearing, held in conjunction with the 

Berkeley Center for Law and 

Technology and the Berkeley Center 

for Competition Policy, focused on 

how markets for patents and 

technology operate in different 

industries and how patent policy 

might be adjusted to respond to 

problems and better promote 

innovation and competition. 

The Commission is working on a 

report related to these hearings. 

(k) Patent and Competition Policy: 

Implications for Promoting Innovation. 

The FTC, the DOJ, and the Department 

of Commerce’s U.S. Patent and 

Trademark Office held a joint public 

workshop on May 26, 2010, to explore 

the intersection of patent policy and 

competition policy and its implications 

for promoting innovation. The 

workshop addressed ways in which 

careful calibration and balancing of 

patent policy and competition policy 

can best promote incentives to innovate. 

(l) Self-Regulatory and Compliance 

Initiatives with Industry. 

Additionally, in the industry selfregulation area, 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, 177 companies have been 

granted ‘‘leniency’’ for self-reported 

minor violations of FTC textile 

regulations. 

Finally, the Commission also has 

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 453, so that they 

can meet the rule’s disclosure 

requirements. Nearly 350 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 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 offers 

franchisees the opportunity to mediate 

claims arising from the law violations. 

Since December 1998, 21 companies 

have agreed to participate in the 

program. 

Effect of the Consumer Financial 

Protection Act of 2010 

On July 21, 2010, President Obama 

signed into law the ‘‘Dodd-Frank Wall 

Street Reform and Consumer Protection 

Act,’’ Public Law No. 111-203. Title X 

of the statute, known as the Consumer 

Financial Protection Act of 2010 (or the 

Consumer Financial Protection Act), 

creates a new Bureau of Consumer 

Financial Protection within the Board of 


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18Reports to Congress Under Sections 318 and 

319 of the Fair and Accurate Credit Transactions 

Act of 2003, Federal Trade Commission, December 

2006 and 2008. The reports may be accessed at the 

FTC’s Web site. December 2006 Report: 

(http://www.ftc.gov/reports/FACTACT/ 

FACTlActlReportl2006.pdf); December 2008 

Report: 

(http://www.ftc.gov/opa/2008/12/factareport.shtm). 

Governors of the Federal Reserve 

System (‘‘Federal Reserve Board’’). Most 

of the Commission’s rulemaking 

authority under certain ‘‘enumerated 

consumer laws’’ will be transferred to 

the new bureau within 6 to 18 months 

after enactment. These laws include all 

or most of the rulemaking authority 

under the Truth in Lending Act, the Fair 

Credit Reporting Act (including the Fair 

and Accurate Credit Transactions Act of 

2003 (‘‘FACTA’’)), the Gramm-LeachBliley Act (‘‘GLB Act’’), the Equal Credit 

Opportunity Act, the Electronic Funds 

Transfer Act, the Federal Deposit 

Insurance Corporation Improvement Act 

of 1991 (‘‘FDICIA’’), and the Omnibus 

Appropriations Act of 2009. While the 

FTC retains its general authority to 

conduct research and studies, it loses 

some of its authority to conduct studies 

under an ‘‘enumerated consumer law.’’ 

The Act also expands the Commission’s 

authority in certain areas—for example, 

with regard to automobile dealers. The 

impact of the Consumer Financial 

Protection Act on the Commission’s 

rulemakings, studies, and guidelines is 

discussed below. 

Rulemakings and Studies Required by 

Statute 

The Congress has enacted laws 

requiring the Commission to undertake 

rulemakings and studies. This section 

discusses required rules and studies. 

The Final Actions section below 

describes actions taken on the required 

rulemakings and studies since the 2009 

Regulatory Plan was published. 

FACTA Rules. The Commission has 

already issued nearly all of the rules 

required by FACTA. These rules are 

codified in several parts of 16 CFR 600 

et seq. The remaining active FACTA 

rulemakings are: 

1. Furnisher Rules. On July 1, 2009, the 

Commission and other Federal 

agencies issued an advance notice of 

proposed rulemaking (‘‘ANPRM’’) that 

seeks to obtain information that 

would assist in determining whether 

it would be appropriate to propose an 

addition to one of the guidelines that 

would delineate the circumstances 

under which a furnisher would be 

expected to provide an account 

opening date, or any other types of 

information, to a consumer reporting 

agency to promote the integrity of the 

information. 74 FR 31529. The 

comment period closed on August 31, 

2009. 

2. Model Forms. The Fair Credit 

Reporting Act (the ‘‘FCRA’’) requires 

the Commission to prescribe a model 

summary of consumers’ rights under 

the FCRA and notices of 

responsibilities for users and 

furnishers of credit report information 

distributed by the consumer reporting 

agencies. The FTC originally issued 

these model notices in 1997 and 

issued revisions in 2004 to reflect 

FACTA changes. On August 6, 2010, 

the Commission issued proposed 

revisions to these models to reflect 

new rules that have been finalized 

under FACTA and to improve the 

clarity and usefulness of the 

documents. The comment period 

closed on September 21, 2010. The 

Commission anticipates that it will 

publish final revised forms no later 

than February 2011. 

These rulemakings are affected by the 

Consumer Financial Protection Act, 

which provides that the Federal Reserve 

Board’s Bureau of Consumer Financial 

Protection assumes responsibility for 

these matters on July 21, 2011 (the 

‘‘designated transfer date’’ as 

determined by the Secretary of the 

Treasury). 

FACTA Studies. On March 27, 2009, 

the Commission issued Amended 

Orders to File a Special Report 

amending the compulsory process 

resolution dated May 16, 2008, entitled 

‘‘Resolution Directing Use of 

Compulsory Process To Study the 

Effects of Credit Scores and CreditBased Insurance Scores Under Section 

215 of the FACT Act.’’ This Amended 

Order requires certain insurance 

companies to produce information for a 

study on the use and effect of creditbased insurance scores on consumers of 

homeowner’s insurance. The Amended 

Orders were served on nine of the 

largest private providers of 

homeowner’s insurance on or about 

April 6, 2009. The insurers have 

submitted responses to the requests. 

This study is not affected by the 

Consumer Financial Protection Act. 

Staff continues to review the data 

produced by the insurers and expects to 

identify a sample set of data to be used 

for the study by late fall 2010. 

The FTC is also conducting a national 

study of the accuracy of consumer 

reports in connection with section 319 

of the FACTA. This study is a followup to the Commission’s two previous 

pilot studies that were undertaken to 

evaluate a potential design for a national 

study. Section 319 requires the FTC to 

study the accuracy and completeness of 

information in consumers’ credit reports 

and to consider methods for improving 

the accuracy and completeness of such 

information. Section 319 of the Act also 

requires the Commission to issue a 

series of biennial reports to Congress 

over a period of 11 years.18 This study 

is also not affected by the Consumer 

Financial Protection Act. 

Mortgage Loans Rule. Section 626 of 

the Omnibus Appropriations Act of 

2009 directed the Commission to 

initiate a rulemaking proceeding with 

respect to mortgage loans and 

prescribed that any violation of the rule 

shall be treated as a violation of a rule 

under section 18 of the Federal Trade 

Commission Act regarding unfair or 

deceptive acts or practices. On June 1, 

2009, the Commission published an 

ANPRM in two parts: (1) Mortgage Acts 

and Practices (‘‘MAP’’) through the life 

cycle of the mortgage loan (i.e., loan 

advertising, marketing, origination, 

appraisals, and servicing), 74 FR 26118, 

and (2) Mortgage Assistance Relief 

Services (‘‘MARS’’) (i.e., practices of 

entities providing assistance to 

consumers in modifying mortgage loans 

or avoiding foreclosure), 74 FR 26130. 

The Commission issued an NPRM for 

MAP-Advertising on September 30, 

2010 (74 FR 60352) and the comment 

period closes on November 15, 2010. 

The Commission anticipates issuing an 

NPRM for MAP-Servicing during early 

2011. The Commission’s rulemaking 

authority in this area will be transferred 

on July 21, 2011, to the Bureau of 

Consumer Financial Protection under 

the provisions of the Consumer 

Financial Protection Act. 

The Commission issued an NPRM in 

the MARS rulemaking on March 9, 

2010. 75 FR 10707. The proposed rule 

would prohibit providers of these 

services from making false or 

misleading claims; mandate that 

providers disclose certain information 

about these services; bar the collection 

of advance fees for these services; 

prohibit persons from providing 

substantial assistance or support to an 

entity they know or consciously avoid 

knowing is engaged in a violation of 

these Rules; and impose recordkeeping 

and compliance requirements. The 

Commission plans to issue a final 

MARS rule by the end of 2010. 

Emergency Technology for Use with 

ATMs. Section 508 of the ‘‘Credit Card 

Accountability Responsibility and 

Disclosure Act of 2009’’ (‘‘Credit CARD 

Act’’), Public Law No. 111-24, mandates 


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19The report is available at 

http://www.ftc.gov/os/2010/05/ 

100504creditcardreport.pdf. 20This report can be found at 

http://www.ftc.gov/os/2010/01/ 

100104dncadditionalreport.pdf. At that time, the 

Commission also released a biennial report 

discussing the National DNC Registry. 

that the Commission prepare a report on 

emergency PIN and alarm button 

devices at automated teller machines 

(ATMs) to automatically alert police 

about crimes at ATMs. The report 

entitled ‘‘Report on Emergency 

Technology for Use with ATMs’’ was 

issued in April 2010.19 The report 

discusses the available information 

about crimes at ATMs and the costs and 

benefits of the emergency technologies 

specified in the act. 

Do Not Call Report. Section 4(b) of the 

‘‘Do-Not-Call Registry Fee Extension Act 

of 2007’’ (‘‘Fee Extension Act’’), Public 

Law 110-188, directs the FTC, in 

consultation with the Federal 

Communications Commission, to 

submit a report to Congress on the 

effectiveness of do-not-call (‘‘DNC’’) 

outreach and enforcement efforts with 

regard to senior citizens and immigrant 

communities, the impact of the 

exceptions to the DNC registry on 

businesses and consumers, and the 

impact of abandoned calls made by 

predictive dialing devices on DNC 

enforcement. The report, which was 

submitted to Congress in December 

2009, discusses these issues, related 

changes to the FTC’s Telemarketing 

Sales Rule, and the enforcement 

initiatives of both agencies.20

Ten-Year Review Program and Calendar 

Year 2009 to 2010 Reviews 

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 U.S.C. 601 

to 612. Under the Commission’s 

program, rules have been reviewed on a 

10-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 U.S.C. 610. 

The program’s goal is to ensure that all 

of the Commission’s rules and guides 

remain in the public interest. It 

complies with the Small Business 

Regulatory Enforcement Act of 1996, 

Public Law No. 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 (Sep. 30, 1993). 

As part of its continuing 10-year 

review plan, the Commission examines 

the effect of rules and guides on small 

businesses and on the marketplace in 

general. These reviews may 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. Most 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. 

In March 2010, the Commission 

determined that it would initiate three 

reviews. 74 FR 12715. On April 5, 2010, 

the Commission initiated an additional 

review for the Children’s Online Privacy 

Protection Rule. Discussion of these four 

reviews follows. 

Children’s Online Privacy Protection 

Rule(‘‘COPPA Rule’’), 16 CFR 312. The 

COPPA Rule requires commercial 

websites and online service providers 

(operators), with certain exceptions, to 

obtain verifiable parental consent before 

collecting, using, or disclosing personal 

information from or about children 

under the age of 13. An operator must 

make reasonable efforts, in light of 

available technology, to ensure that the 

person providing consent is the child’s 

parent. The Commission issued an 

ANPRM requesting comments on the 

economic impact and benefits of the 

rule; possible conflict between the rule 

and other Federal, State, and local laws 

and regulations; and the effect on the 

rule of technological, economic, and 

other industry changes. 75 FR 17089. 

The Commission held a public 

roundtable on the rule on June 2, 2010; 

and the comment period, as extended, 

ended on July 12, 2010. Staff anticipates 

sending a recommendation for next 

action to the Commission by the end of 

2010. 

Rule on Retail Food Store Advertising 

and Marketing Practices(‘‘Unavailability 

Rule’’), 16 CFR 424. The Unavailability 

Rule states that it is a violation of 

section 5 of the Federal Trade 

Commission Act for retail stores of food, 

groceries, or other merchandise to 

advertise products for sale at a stated 

price if those stores do not have the 

advertised products in stock and readily 

available to customers during the 

effective period of the advertisement, 

unless the advertisement clearly 

discloses that supplies of the advertised 

products are limited or are available 

only at some outlets. The rule is 

intended to benefit consumers by 

ensuring that advertised items are 

available, that advertising-induced 

purchasing trips are not fruitless, and 

that store prices accurately reflect the 

prices appearing in the ads. Staff is 

reviewing the rule and intends to 

forward a recommendation to the 

Commission before the end of 2010. 

Labeling Requirements for Alternative 

Fuels and Alternative Fueled Vehicles 

Rule(‘‘Alternative Fuel Rule’’), 16 CFR 

309. The Alternative Fuel Rule, which 

became effective on November 20, 1995, 

and was last reviewed in 2004, requires 

disclosure of appropriate cost and 

benefit information to enable consumers 

to make reasonable purchasing choices 

and comparisons between non-liquid 

alternative fuels as well as alternativefueled vehicles. By November 2010, 

staff anticipates that the Commission 

will request comments on the rule. 

Preservation of Consumers’ Claims 

and Defenses Rule(‘‘Holder-in-Due 

Course Rule’’), 16 CFR 433. Issued in 

1975, the Holder-in-Due Course Rule 

requires sellers to include language in 

consumer credit contracts that preserves 

consumers’ claims and defenses against 

the seller. This rule eliminated the 

holder-in-due course doctrine as a legal 

defense for separating a consumer’s 

obligation to pay from the seller’s duty 

to perform by requiring that consumer 

credit and loan contracts contain one of 

two clauses to preserve the buyer’s right 

to assert sales-related claims and 

defenses against a ‘‘holder’’ of the 

contracts. This rule was initially 

scheduled to be reviewed during 2010 

as part of the periodic review process. 

However, that prospective review has 

been put on hold until the Commission 

can consult with the new Bureau of 

Consumer Financial Protection that was 

created pursuant to the Consumer 

Financial Protection Act about Holder 

in Due Course issues. 

Ongoing Reviews 

Since the publication of the 2009 

Regulatory Plan, the Commission has 


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21 Pending completion of the proceeding initiated 

with this notice, business opportunities presently 

covered by the requirements of the original Rule 

will remain covered, as set forth as part 437 of the 

final amended Rule. 72 FR 15444 (March 30, 2007). 22 The report is available at 

http://www.ftc.gov/opa/2010/10.businessopp.shtm 

initiated three new rulemaking 

proceedings and is continuing review of 

a number of rules and guides. The new 

rulemaking proceedings are discussed 

first under (a) Rules, followed by the 

other rule reviews, and then (b) Guides. 

(a) Rules 

Mail Order Rule. The Mail Order 

Rule, 16 CFR 435, requires that, when 

sellers advertise merchandise, they must 

have a reasonable basis for stating or 

implying that they can ship within a 

certain time. The Commission sought 

comments about non-substantive 

changes to the rule to bring it into 

conformity with changing conditions; 

including consumers’ usage of means 

other than the telephone to access the 

Internet when ordering, consumers 

paying for merchandise by demand draft 

or debit card, and merchants using 

alternative methods to make prompt 

rule-required refunds. 72 FR 51728 

(Sep. 11, 2007). Staff has reviewed the 

comments and anticipates sending a 

recommendation to the Commission by 

the end of 2010. 

Business Opportunity Rule. The 

proposed Business Opportunity Rule 

stems from the recently concluded 

review of the Franchise Rule, where 

staff recommended that the rule be split 

into two parts: One part addressing 

franchise issues (16 CFR 436) and 

another part addressing business 

opportunity issues (16 CFR 437).21 After 

reviewing the comments from an NPRM, 

71 FR 19054 (Apr. 12, 2006), the 

Commission issued a revised NPRM on 

March 26, 2008, that would require 

business opportunity sellers to furnish 

prospective purchasers with specific 

information that is material to the 

consumer’s decision as to whether to 

purchase a business opportunity and 

which should help the purchaser 

identify fraudulent offerings. 73 FR 

16110. The revised NPRM comment 

period ended on May 27, 2008, and the 

rebuttal comment period ended on June 

16, 2008. A public workshop was held 

on June 1, 2009, to explore changes to 

the proposed rule and a related 

comment period closed on June 30, 

2009. On October 28, 2010, the 

Commission released a staff report22

recommending that coverage of the 

Business Opportunity Rule be expanded 

to include work-at-home opportunities 

such as envelope stuffing, medical 

billing, and product assembly, many of 

which have not been covered before. 

FTC staff also recommends streamlining 

the disclosures require by the business 

opportunity rule so that companies or 

individuals selling business 

opportunities make important 

disclosures to consumers on a simple, 

easy-to-read document. If adopted, the 

changes will make it less burdensome 

for legitimate sellers to comply with the 

Rule, while still protecting consumers 

from ‘‘widespread and persistent’’ 

business opportunity fraud. Public 

comments on the staff report will be 

accepted until January 18, 2011. 

Hart-Scott-Rodino Rules. For the HartScott-Rodino Premerger Notification 

Rules (HSR Rules), 16 CFR 801 to 803, 

Bureau of Competition staff is 

continuing to review various HSR Rule 

provisions. On August 13, 2010, the 

Commission announced it was seeking 

public comments on proposed changes 

designed to streamline the HSR form 

and focus on the information most 

needed by the agencies in their initial 

merger review. 75 FR 57110. The 

proposal eliminates requests for 

unnecessary information. The new form, 

however, would require additional 

information that is needed to help the 

FTC and DOJ during their initial review 

of transactions. The comment period 

closed on October 18, 2010. 

Used Car Rule. The Used Motor 

Vehicle Trade Regulation Rule (‘‘Used 

Car Rule’’), 16 CFR 455, sets out the 

general duties of a used vehicle dealer, 

requires that a completed Buyers Guide 

be posted at all times on the side 

window of each used car a dealer offers 

for sale, and mandates disclosure of 

whether the vehicle is covered by a 

warranty and, if so, the type and 

duration of the warranty coverage, or 

whether the vehicle is being sold ‘‘as 

is—no warranty.’’ The Commission 

published a notice seeking public 

comments on the effectiveness and 

impact of the rule. 73 FR 42285 (Jul. 21, 

2008). The notice seeks comments on a 

range of issues including, among others, 

whether a bilingual Buyers Guide would 

be useful or practicable, as well as what 

form such a Buyers Guide should take. 

Second, the notice seeks comments on 

possible changes to the Buyers Guide 

that reflect new warranty products, such 

as certified used car warranties, that 

have become increasingly popular since 

the rule was last reviewed. Finally, the 

notice seeks comments on other issues 

including the continuing need for the 

rule and its economic impact, the effect 

of the rule on deception in the used car 

market, and the rule’s interaction with 

other regulations. The comment period, 

as extended and then reopened, ended 

on June 15, 2009. Staff anticipates 

sending a recommendation to the 

Commission by November 2010. 

Cooling-Off Rule. The Cooling-Off 

Rule requires that a consumer be given 

a 3-day right to cancel certain sales 

greater than $25.00 that occur at a place 

other than a seller’s place of business. 

The rule also requires a seller to notify 

buyers orally of the right to cancel; to 

provide buyers with a dated receipt or 

copy of the contract containing the 

name and address of the seller and 

notice of cancellation rights; and to 

provide buyers with forms which buyers 

may use to cancel the contract. An 

ANPRM seeking comment was 

published on April 21, 2009. 74 FR 

18170. The comment period was 

supposed to close on June 22, 2009, but 

was extended to September 25, 2009. 74 

FR 36972 (Jul. 27, 2009). Staff is 

reviewing comments as they are 

received and expects to prepare a 

recommendation for the Commission by 

the end of 2010. 

Fuel Ratings Rule. The Fuel Ratings 

Rule sets out a uniform method for 

determining the octane rating of 

gasoline from the refiner through the 

chain of distribution to the point of 

retail sale. The rule enables consumers 

to buy gasoline with an appropriate 

octane rating for their vehicle and 

establishes standard procedures for 

determining, certifying, and posting 

octane ratings. On March 3, 2009, the 

Commission published an ANPRM and 

requested comments on the rule as part 

of its systematic periodic review of 

current rules and guides. 74 FR 9054. 

On March 16, 2010, the Commission 

issued an NPRM proposing to adopt 

rating, certification, and labeling 

requirements for certain ethanol fuels; 

revise the labeling requirements for 

fuels with at least 70 percent ethanol; 

and allow the use of an alternative 

octane rating method. 75 FR 12470. The 

comment period has ended. Staff 

anticipates that the Commission will 

issue a final rule by the end of 2010. 

Negative Option Rule. The Negative 

Option Rule governs the operation of 

prenotification subscription plans. 

Under these plans, sellers ship 

merchandise automatically to their 

subscribers and bill them for the 

merchandise within a prescribed time. 

The rule protects consumers by 

requiring the disclosure of the terms of 

membership clearly and conspicuously 

and establishes procedures for 

administering the subscription plans. 

An ANPRM was published on May 14, 


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79702 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

2009, 74 FR 22720, and the comment 

period closed on July 27, 2009. On 

August 7, 2009, the Commission 

reopened and extended the comment 

period until October 13, 2009. 74 FR 

40121. Staff anticipates sending a 

recommendation to the Commission by 

December 2010. 

Pay-Per-Call Rule. The Commission’s 

review of the Pay-Per-Call Rule, 16 CFR 

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 

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. The review 

record has remained open to encourage 

additional comments on expansion of 

the rule’s coverage. Staff expects to 

prepare a recommendation for the 

Commission by December 2011. 

(b) Guides 

Fuel Economy Guide. The Fuel 

Economy Guide for new automobiles, 16 

CFR 259, was adopted in 1975 to 

prevent deceptive fuel economy 

advertising and to facilitate the use of 

fuel economy information in 

advertising. As part of its regular review 

of all rules and guides, the Commission 

issued a request for comments on May 

9, 2007, on whether to retain or amend 

the guide. 72 FR 26328. The 

Commission sought comments on, 

among other things, whether there is a 

continuing need for the guide and, if so, 

what changes should be made to it, if 

any, in light of Environmental 

Protection Agency amendments to fuel 

economy labeling requirements for 

automobiles. On April 28, 2009, the 

Commission published proposed 

amendments to the Guide. 74 FR 19148. 

The deadline for comments was June 16, 

2009. Staff is reviewing the comments 

and expects to make a recommendation 

by the end of 2010. 

Green Guides. The Green Guides, 16 

CFR 260, outline general principles that 

apply to all environmental marketing 

claims and provide guidance regarding 

specific environmental claims. The 

Commission sought comment on the 

need for the guides and their economic 

impact, the effect of the guides on the 

accuracy of various environmental 

claims, and the interaction of the guides 

with other environmental marketing 

regulations. 72 FR 66091 (Nov. 27, 

2007). As part of its review, during 

2008, the Commission held workshops 

and received comments in three specific 

areas: 1) Carbon offsets and renewable 

energy certificates (Jan. 8, 2008); 2) 

environmental packaging claims and 

green packaging (Apr. 30, 2008); and 3) 

developments in green building and 

textiles claims and consumer perception 

of such claims (Jul. 15, 2008). After 

reviewing the , the transcripts of the 

three public workshops that explored 

the emerging issues, and the results of 

its additional consumer perception 

research, the Commission proposed on 

October 15, 2010, several modifications 

and additions to the Guides that aim to 

respond to changes in the marketplace 

and help marketers avoid making unfair 

or deceptive environmental marketing 

claims. 75 FR 63552. The proposed 

changes to the Green Guides include 

new guidance on marketers’ use of 

product certifications and seals of 

approval, ‘‘renewable energy’’ claims, 

‘‘renewable materials’’ claims, and 

‘‘carbon offset’’ claims. The Commission 

seeks public comment by December 10, 

2010. 

Fair Debt Collection Practices Act 

(FDCPA) Enforcement Policy Statement 

Regarding Communications in 

Connection With Collection of a 

Decedent’s Debt. The Commission 

requests public comment on a proposed 

statement of enforcement policy 

regarding communications in 

connection with collection of a 

decedent’s debts. The statement 

addresses three issues pertaining to debt 

collectors who attempt to collect on the 

debts of deceased debtors. First, the 

proposed statement announces that the 

FTC will not bring enforcement actions 

for violations of Section 805(b) of the 

FDCPA, 15 USC, 1692c(b), against 

collectors, who, in connection with the 

collection of a decedent’s debt, 

communicate with a person who has 

authority to pay the decedent’s debt 

from the assets of the decedent’s estate. 

Second, the proposed statement clarifies 

how a debt collector may locate the 

appropriate person with whom to 

discuss the decedent’s debt. Third, the 

proposed statement emphasizes to 

collectors that misleading consumers 

about their personal obligation to pay a 

decedent’s debt is a violation of the 

FDCPA and Section 5 of the FTC Act, 

15 USC 45. Public comments must be 

received by November 8, 2010. 

Vocational Schools Guides. The 

Commission is seeking public 

comments on its Private Vocational and 

Distance Education Schools Guides, 

commonly known as the Vocational 

Schools Guides. 74 FR 37973 (Jul. 30, 

2009). Issued in 1972 and most recently 

amended in 1998 to add a provision 

addressing misrepresentations related to 

post-graduation employment, the guides 

advise businesses offering vocational 

training courses—either on the school’s 

premises or through distance education, 

such as correspondence courses or the 

Internet—how to avoid unfair and 

deceptive practices in the advertising, 

marketing, or sale of their courses. The 

comment period closed on October 16, 

2009. Staff is reviewing comments and 

anticipates sending a recommendation 

for next action to the Commission by the 

end of 2010. 

Final Actions 

Since the publication of the 2009 

Regulatory Plan, the Commission has 

issued the following final rules or taken 

other actions to terminate rulemaking 

proceedings. 

Telemarketing Sales Rule (TSR) - Debt 

Relief Services. The Commission issued 

an NPRM seeking comments on a 

proposal to amend the TSR to address 

the sale of debt relief services, 

including: For-profit credit counselors; 

debt settlement companies that promise 

to obtain substantially reduced, lump 

sum settlements of consumers’ debts; 

and debt negotiators that offer to obtain 

interest rate reductions or other 

concessions to lower consumers’ 

monthly payments. 74 FR 41988 (Aug. 

19, 2008). The comment period, as 

extended, closed on October 26, 2009, 

and the Commission held a public 

forum in November 2009. This 

rulemaking was not affected by the 

Consumer Financial Protection Act. 

On July 29, 2010, the Commission 

announced a final rule providing that 

telemarketers of for-profit companies 

that sell debt relief services over the 

telephone may no longer charge a fee 

before they settle or reduce a customer’s 

credit card or other unsecured debt. The 

rule also imposes conditions on 

accounts that debt relief companies may 

establish for consumers to set aside their 

fees and savings for payment to 

creditors. The rule also requires certain 

disclosures to consumers related to the 

fundamental aspects of their services 

(time to see results, cost) and prohibits 

misrepresentations related to success 

rates and non-profit status. With the 

exception of the advance fee ban which 

is effective October 27, 2010, the rule’s 


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23The agencies are the Federal Reserve Board, the 

Federal Deposit Insurance Corporation, the Office of 

the Comptroller of the Currency, the Office of Thrift 

Supervision, the National Credit Union 

Administration, the Securities and Exchange 

Commission, and the Commodity Futures Trading 

Corporation. 

provisions are effective September 27, 

2010. 75 FR 48458. On October 27, 

2010, the Commission announced an 

enforcement policy for the TSR Debt 

Relief Services Rule: the Commission 

will defer enforcement of the new rule 

for tax debt relief services until further 

notice. The Enforcement policy states, 

however, that tax debt relief services 

must comply with the other portions of 

the FTS’s Telemarketing Sales Rule 

during the enforcement deferral period. 

Companies that sell other kinds of debt 

relief services over the telephone 

continue to be subject to enforcement of 

the TSR Debt Relief Services Rule, 

including the prohibition against 

charging fees before settling or reducing 

a consumer’s credit card or other 

unsecured debt. 

Free Credit Reports: Deceptive 

Marketing Practices. Section 205 of the 

Credit CARD Act required the 

Commission to issue a rule to prevent 

deceptive marketing of ‘‘free credit 

reports.’’ On October 15, 2009, the 

Commission issued an NPRM to amend 

the Free Credit Reports Rule to require 

prominent disclosures in advertising for 

‘‘free credit reports’’ and to address 

practices that interfere with consumers’ 

ability to obtain file disclosures from 

consumer reporting agencies. 74 FR 

52915. As required by statute, the 

Commission issued a final rule on 

February 22, 2010, which was published 

in the Federal Register. 75 FR 9726. 

With the exception of disclosure 

provisions related to television and 

radio advertisements effective 

September 1, 2010, the rule became 

effective on April 2, 2010. 

FACTA Risk-Based Pricing Rule. The 

Commission, jointly with the Federal 

Reserve, published a risk-based pricing 

proposal for comment on May 19, 2008. 

73 FR 28966. The comment period 

ended on August 18, 2008. Risk-based 

pricing refers to the practice of setting 

or adjusting the price and other terms of 

credit offered or extended to a particular 

consumer to reflect the risk of 

nonpayment by that consumer. This 

statutorily required rulemaking would 

address the form, content, time, manner, 

definitions, exceptions, and model of a 

risk-based pricing notice. 

The agencies issued final rules on 

January 15, 2010. 75 FR 2724. The final 

rules generally require a creditor to 

provide a risk-based pricing notice to a 

consumer when the creditor uses a 

consumer report to grant or extend 

credit to the consumer on terms that are 

materially less favorable than the most 

favorable terms available to a substantial 

proportion of consumers from or 

through that creditor. The final rules 

also provide two alternative means by 

which creditors can determine when 

they are offering credit on terms that are 

materially less favorable and include 

certain exceptions to the general rule, 

including exceptions for creditors that a 

disclose a consumer’s credit score in 

conjunction with additional information 

providing context for the credit score 

disclosure. The rules are effective 

January 1, 2011. 

FDICIA Rule. The Federal Deposit 

Insurance Corporation Improvement Act 

of 1991 assigned to the Commission 

responsibilities for certain non-federally 

insured depository institutions (‘‘DIs’’) 

and private deposit insurers of such DIs. 

The FTC is required to prescribe, by 

regulation or order, the manner and 

content of certain disclosures required 

of DIs that lack Federal deposit 

insurance. From 1993 to 2003, the 

Commission was statutorily barred on 

an annual basis from appropriating 

funds for purposes of complying with 

FDICIA. The Consolidated 

Appropriations Act of 2004 and yearly 

appropriations thereafter have not 

imposed the same funding prohibition, 

and the Commission issued an NPRM 

on March 16, 2005. 70 FR 12823. 

Subsequently, Congress passed the 

Financial Services Regulatory Relief Act 

of 2006 (‘‘FSRRA’’) amending FDICIA 

and addressing several aspects of the 

FTC’s proposed rule. A revised NPRM 

consistent with the FSRRA was issued 

on March 14, 2009. 74 FR 10843. The 

Commission issued a final rule on June 

4, 2010, effective July 6, 2010. 75 FR 

31682. 

Gramm-Leach-Bliley Rule. Pursuant 

to section 728 of the Financial Services 

Relief Act of 2006, Public Law No.109- 

351, which added section 503(e) to the 

GLB Act, the Commission together with 

seven other Federal agencies23 was 

directed to propose a model form that 

may be used at the option of financial 

institutions for the privacy notices 

required under GLB. The 2006 

amendment provided that the agencies 

must propose the model form within 

280 days after enactment or by April 11, 

2007. On March 29, 2007, the GLB 

agencies issued an NPRM proposing as 

the model form the prototype privacy 

notice developed during the consumer 

testing research project undertaken by 

first six, and then seven, of these 

agencies. 72 FR 14940. On November 

19, 2009, the Commission and the seven 

agencies announced a model form that 

financial institutions may rely on as a 

safe harbor to provide disclosures under 

the privacy rule. 74 FR 62890 at 62965- 

74 (amendments to FTC rules). With the 

exception of certain amendments 

effective January 1, 2012, the rules 

became effective December 31, 2009. 

Energy Labeling Rule for Light Bulbs. 

Section 321 of the Energy Security and 

Independence Act (ESIA) required the 

Commission to conduct a rulemaking to 

consider the effectiveness of current 

energy labeling for light bulbs and to 

consider alternative labeling 

approaches. In response to that 

directive, the Commission issued an 

ANPRM on July 17, 2008, seeking 

comments on the effectiveness of 

current labeling requirements for lamp 

packages and possible alternatives to 

those requirements. 73 FR 40988. After 

reviewing the comments, the 

Commission issued an NPRM on 

November 10, 2009, proposing a twopanel labeling format for light bulb 

packages and mandatory disclosures 

including brightness, energy cost, bulb 

life, color appearance, wattage, and 

mercury content. 74 FR 57950. On July 

19, 2010, the Commission issued a final 

rule adopting the two-panel labeling 

format and the brightness, energy-cost, 

and other disclosure requirements. 75 

FR 41696. With the exception of certain 

amendments that will be become 

effective on August 18, 2010, the new 

labeling requirements become effective 

on July 19, 2011. The Commission also 

sought further comment by September 

20, 2010, on several issues for 

consideration in any subsequent 

rulemaking. 

Consumer Electronics Rule. The 

Commission has authority under section 

325 of ESIA to promulgate energy 

labeling rules for consumer electronic 

(Consumer Electronics Rule). On March 

16, 2009, the Commission published an 

ANPRM seeking comments on whether 

it should require labels for consumer 

electronics, including televisions, 

computers, video recorder boxes, and 

certain other equipment; the 

disclosures, need, and format or labels, 

and appropriate test procedures. 74 FR 

11045. On March 11, 2010, the 

Commission issued an NPRM that 

would require EnergyGuide labels and 

disclose requirement for televisions. 

The Commission did not propose 

requirements for other consumer 

electronics but it did seek comments on 

the subject. 75 FR 11483. The comment 

period closed on May 14, 2010. As part 


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79704 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

of this effort the Commission scheduled 

a public meeting on April 16, 2010. On 

October 27, 2010, the Commission 

announced it was issuing a final rule 

that will require televisions 

manufactured after May 10, 20100, to 

display EnergyGuide labels that include 

information on estimated yearly energy 

and the cost range compared to similar 

models. 

Amplifier Rule. The Amplifier Rule, 

16 CFR 432, assists consumers in 

purchasing by standardizing the 

measurement and disclosure of various 

performance attributes of power 

amplification equipment for home 

entertainment purposes. The rule makes 

it an unfair or deceptive act or practice 

for manufacturers and sellers of sound 

power amplification equipment for 

home entertainment purposes to fail to 

disclose certain performance 

information in connection with direct or 

indirect representations of power 

output, power band, frequency, or 

distortion characteristics. The rule also 

sets out standard test conditions for 

performing the measurements that 

support the required performance 

disclosures. On February 27, 2008, the 

Commission published a request for 

comments including a number of 

specific issues related to changes in 

technology and products. 73 FR 10403. 

The comment period ended on May 12, 

2008. On January 26, 2010, the 

Commission announced it was retaining 

the rule as currently written but issued 

guidance concerning testing 

requirements for measuring power 

ratings of multichannel amplifiers. 75 

FR 3985. 

Smokeless Tobacco Regulations. The 

Commission’s review of the Regulations 

Under the Comprehensive Smokeless 

Tobacco Health Education Act of 1986 

(‘‘Smokeless Tobacco Regulations’’), 16 

CFR 307, has been completed. The 

Smokeless Tobacco Regulations govern 

the format and display of statutorily 

mandated health warnings on all 

packages and advertisements for 

smokeless tobacco. On June 22, 2009, 

Congress enacted the ‘‘Family Smoking 

Prevention and Tobacco Control Act,’’ 

Public Law No. 111-31, which imposed 

new requirements for smokeless tobacco 

health warnings and transferred 

authority over these warnings to the 

Department of Health and Human 

Services. As a result, the Commission 

closed both the regulatory review and a 

separate NPRM (published in 1993). 75 

FR 3664. On September 28, 2010, the 

Commission rescinded its smokeless 

tobacco regulations, concluding they no 

longer serve any purpose and actually 

conflict with the new statutory 

provisions. 75 FR 59609. Indeed, 

retention of these regulations could 

generate confusion if some smokeless 

tobacco manufacturers and importers 

mistakenly believe that they reflect 

current legal requirements. 

Endorsements and Testimonials in 

Advertising Guides. On January 16, 

2007, the Commission requested public 

comments on the overall costs, benefits, 

and regulatory and economic impact of 

its Guides Concerning the Use of 

Endorsements and Testimonials in 

Advertising, 16 CFR 255. The 

Commission also released consumer 

research it commissioned regarding the 

messages conveyed by consumer 

endorsements and sought comment both 

on this research and upon several other 

specific endorsement-related issues. 72 

FR 2214 (Jan. 18, 2007). After reviewing 

the comments, the Commission 

proposed changes to the guides and 

requested public comments. 73 FR 

72374 (Nov. 28, 2008). The initial 

comment period ended on January 30, 

2009, but was subsequently extended to 

March 2, 2009. 74 FR 5810 (Feb. 2, 

2009). On October 5, 2009, the 

Commission announced revisions to the 

guides effective December 1, 2009. 74 

FR 53214. Under the revised Guides, 

advertisements that feature a consumer 

and convey his or her experience with 

a product or service as typical when that 

is not the case will be required to clearly 

disclose the results that consumers can 

generally expect. In contrast to the prior 

version of the Guides, which allowed 

advertisers to describe unusual results 

in a testimonial as long as they included 

a disclaimer such as ‘‘results not 

typical,’’ the revised Guides no longer 

contain this safe harbor. The revised 

Guides also add new examples (i.e., 

bloggers or celebrity endorsers) to 

illustrate the long standing principle 

that ‘‘material connections’’ (sometimes 

payments or free products) between 

advertisers and endorsers—connections 

that consumers would not expect—must 

be disclosed. 

Guides for Jewelry, Precious Metals 

and Pewter Industries. After issuing a 

staff advisory opinion indicating that 

the Commission’s current guidelines for 

Jewelry, Precious Metals and Pewter 

Industries, 16 CFR part 23, do 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 nondeceptively mark or describe products 

containing between 500 and 850 parts 

per thousand pure platinum and no 

other platinum group metals. 70 FR 

(July 5. 2005). After reviewing the 

comments, the Commission issued a 

notice on February 20, 2008, seeking 

comment on proposals to amend the 

platinum section of the Guides to 

address the new platinum alloys. 73 FR 

10190. The extended comment period 

ended on August 25, 2008. 73 FR 22848 

(April 28, 2008). 

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, while minimizing the 

regulatory burdens on businesses. The 

Commission will continue working 

toward these goals. The Commission’s 

10-year review program is patterned 

after provisions in the Regulatory 

Flexibility Act and complies with the 

Small Business Regulatory Enforcement 

Fairness Act of 1996. The Commission’s 

10-year program also is consistent with 

section 5(a) of Executive Order 12866, 

which directs executive branch agencies 

to develop a plan to reevaluate 

periodically all of their significant 

existing regulations. 58 FR 51735 (Sep. 

30, 1993). 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. 

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. 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 wellbeing of the American people.’’ E.O. 

12866, section 1. 

II. Regulatory Actions 

(1) Have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy; a sector of the economy; 

productivity; competition; jobs; the 

environment; public health or safety; or 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79705 

24Section 3(f) of the Executive Order defines a 

regulatory action to be ‘‘significant’’ if it is likely 

to result in a rule that may: 

State, local, or tribal governments or 

communities; 

(2) Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

(3) Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs, or the rights and 

obligations of recipients thereof; or 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in this Executive order. 

The Commission has no proposed 

rules that would be a ‘‘significant 

regulatory action’’ under the definition 

in Executive Order 12866.24

BILLING CODE 6750–01–S 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79706 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

NATIONAL INDIAN GAMING 

COMMISSION (NIGC) 

Statement of Regulatory Priorities 

Congress adopted the Indian Gaming 

Regulatory Act (IGRA) (Pub. L. 100-497, 

102 Stat. 2475) in 1988. A primary 

purpose of the Act is to ‘‘provide a 

statutory basis for the operation of 

gaming by Indian tribes as a means of 

promoting tribal economic 

development, self-sufficiency, and 

strong tribal governments.’’ The Act 

established the National Indian Gaming 

Commission (NIGC or the Commission) 

to protect such gaming, among other 

things, as a means of generating tribal 

revenue. 

At its core, Indian gaming is a 

function of sovereignty exercised by 

tribal governments. In addition, the 

Federal Government maintains a 

government-to-government relationship 

with the tribes—a responsibility of the 

NIGC. Thus, while the Agency is 

committed to strong regulation of Indian 

gaming, the Commission is committed 

to strengthening government-togovernment relations by engaging in 

meaningful consultation with tribes to 

fulfill the intent of the IGRA. Our vision 

is to adhere to principles of good 

government, including transparency to 

promote Agency accountability and 

fiscal responsibility, to operate 

consistently to ensure fairness and 

clarity in the administration of the 

IGRA, and to respect the responsibilities 

of each sovereign in order to fully 

promote tribal economic development, 

self-sufficiency, and strong tribal 

governments. The NIGC is committed to 

working with tribes to ensure the 

integrity of the industry by exercising its 

regulatory responsibilities through 

assistance, compliance, and 

enforcement activities. 

The Commission intends to review its 

current regulations and guidance for 

effectiveness and to consult with tribes 

about relevancy, consistency in 

application, and limitations or barriers 

to implementation, based upon their 

experiences, to identify areas of 

improvement and any needed 

amendments. Accordingly, the 

Commission has added a regulatory 

review action to this semiannual 

regulatory agenda. Regarding those 

regulatory actions identified in spring 

2010, the Commission has maintained 

those descriptions but extended the 

timetable of each regulatory action by 1 

year to reflect this review. The 

Commission is withdrawing the notice 

regarding Indian hiring preference 

because it will implement the 

preference through internal policy. The 

Commission recently began an initial 

series of government-to-government 

consultations with tribes seeking their 

views on how to prioritize its review of 

the regulations. The Commission will 

continue with government-togovernment consultation on this issue 

as it develops a regulatory review 

schedule. 

NIGC 

PROPOSED RULE STAGE 

172. TRIBAL BACKGROUND 

INVESTIGATION SUBMISSION 

REQUIREMENTS AND TIMING 

Priority: 

Other Significant 

Legal Authority: 

25 USC 2706(b)(3); 25 USC 2706(b)(10); 

25 USC 2710(b)(2)(F)(ii); 25 USC 

2710(c)(1)–(2); 25 USC 2710(d)(2)(A) 

CFR Citation: 

25 CFR 556; 25 CFR 558 

Legal Deadline: 

None 

Abstract: 

It is necessary for the National Indian 

Gaming Commission (NIGC) to modify 

certain regulations concerning 

background investigations and licensing 

to streamline the process for submitting 

information, ensure that the process 

complies with the Indian Gaming 

Regulatory Act (IGRA), and distinguish 

the requirements for temporary and 

permanent licenses. 

Statement of Need: 

Modifications to specific background 

investigation and licensing regulations 

are needed to ensure compliance with 

the Indian Gaming Regulatory Act 

(IGRA), which mandates that certain 

notifications be submitted to the 

Commission. Modifications are also 

needed to reduce the quantity of 

documents submitted to the 

Commission under these regulations 

and to distinguish the requirements for 

temporary and permanent licenses. 

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 to 

assure 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)). Sections 2710(b)(2)(F) and 

2710(d)(A) require tribes to have an 

adequate system for background 

investigations of primary management 

officials and key employees and inform 

the Commission of the results of those 

investigations. Under section 2710(c), 

the Commission may also object to 

licenses or require a tribe to suspend 

a license. The Commission relies on 

these sections of the statute to 

authorize the modification of the 

background and licensing regulations to 

ensure compliance with IGRA, reduce 

the quantity of documents submitted to 

the Commission, and distinguish the 

requirements for temporary and 

permanent licenses. 

Alternatives: 

If the Commission does not modify 

these regulations to reduce the quantity 

of documents submitted under them, 

tribes will continue to be required to 

submit these documents to the 

Commission. Further, to ensure 

compliance with IGRA, the 

modifications mandating notifications 

to the Commission regarding the results 

of background checks and the issuance 

of temporary and permanent gaming 

licenses must be made. 

Anticipated Cost and Benefits: 

These modifications to the background 

investigation and licensing regulations 

will reduce the cost of regulation to the 

Federal Government by reducing the 

amount of documents received from 

tribes that must be processed and 

retained. Further, these modifications 

will reduce the quantity of documents 

that tribes are required to submit to the 

NIGC, which will result in a cost 

savings to the tribes. There are minimal 

anticipated cost increases to tribal 

governments due to additional 

notifications to the NIGC. 

Risks: 

There are no known risks to this 

regulatory action. 

Timetable: 

Action Date FR Cite 

NPRM 09/00/11 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 79707 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Tribal 

Agency Contact: 

Heather M Nakai 

Staff Attorney 

National Indian Gaming Commission 

1441 L Street NW. 

Suite 9100 

Washington, DC 20005 

Phone: 202 632–7003 

Fax: 202 632–7066 

RIN: 3141–AA15 

NIGC 

173. CLASS II AND CLASS III 

MINIMUM INTERNAL CONTROL 

STANDARDS 

Priority: 

Other Significant 

Legal Authority: 

25 USC 2706(b)(10); 25 USC 

2706(b)(1)–(4); 25 USC 

2710(d)(3)(C)(vi); 25 USC 

2710(d)(7)(B)(vii) 

CFR Citation: 

25 CFR 542; 25 CFR 543 

Legal Deadline: 

None 

Abstract: 

The National Indian Gaming 

Commission is revising the existing 

minimum internal control standards 

(MICS) to reflect the changing 

technologies in the industry. The 

Commission will routinely revise the 

MICS in response to these changes. It 

is also continuing with its plan to 

clarify the regulatory structure by 

segregating Class II MICS from Class III. 

Statement of Need: 

The rapid evolution of gaming 

technology and regulatory structures in 

Indian gaming brings new risks and 

requires a distinction between the 

control standards for Class II and Class 

III gaming. Periodic review and revision 

of existing standards are necessary to 

ensure that they remain relevant and 

continue to adequately protect tribal 

gaming assets and the interests of 

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 to 

assure that gaming is conducted fairly 

and honestly. (25 U.S.C. 2702). 

Congress authorized NIGC to 

promulgate regulations and guidelines 

to implement IGRA’s provisions. 25 

U.S.C. 2706(b)(10). Federal MICS are 

perhaps the single most important tool 

for ensuring IGRA’s purposes are 

carried out. The Commission is charged 

with monitoring gaming conducted on 

Indian lands (25 U.S.C. 2706(b)(1)), and 

this monitoring takes different forms 

depending on the class of gaming being 

conducted. With regard to Class II 

gaming, NIGC’s responsibility includes 

inspecting and examining the premises 

located on Indian lands on which Class 

II gaming is conducted and auditing all 

papers, books, and records respecting 

gross revenues of Class II gaming 

conducted on Indian lands and any 

other matters necessary to carry out the 

duties of the Commission under IGRA. 

(25 U.S.C. 2706(b)(2),(4)). Therefore, 

NIGC is amending its Class II MICS 

regulations to set standards for 

inspections, contents of records, etc. 

With regard to Class III MICS, however, 

the NIGC’s role is to provide guidance 

that tribes and states may then include 

in ordinances, compacts, or procedures 

or use as a model. Pursuant to 25 

U.S.C. 2710(d)(3)(C)(vi), some states 

compact with tribes to require either 

the standards set forth in NIGC’s Class 

III MICS, or others at least as stringent. 

(See, for example: Model Tribal Gaming 

Compact, Oklahoma, Part 5(B); Class III 

Gaming Compact Between the Fort 

Belknap Indian Community and the 

State of Montana, App. (A)(III), 

approved November 9, 2007; and 

Compact Between the Omaha Tribe and 

State of Iowa, Section 11, approved 

January 19, 2007.) Moreover, several 

tribes have voluntarily adopted NIGC’s 

Class III MICS into their ordinances, 

and thus granted NIGC authority 

pursuant to the enforcement provisions 

of 25 U.S.C. 2713. The Commission 

relies on these sections to authorize 

promulgations of MICS to ensure 

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 

First NPRM Comment 

Period End 

01/18/05 

Second NPRM 03/10/05 70 FR 11893 

Second NPRM 

Comment Period 

End 

04/25/05 

Final Action on First 

Rule 

05/04/05 70 FR 23011 

Final Action on 

Second Rule 

08/12/05 70 FR 47097 

Third NPRM 11/15/05 70 FR 69293 

Third NPRM 

Comment Period 

End 

12/30/05 

Final Action on Third 

Rule (1) 

05/11/06 71 FR 27385 

Fourth NPRM 09/00/11 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Tribal 

Agency Contact: 

Jennifer Ward 

Staff Attorney 

National Indian Gaming Commission 

1441 L Street NW. 

Suite 9100 

Washington, DC 20005 

Phone: 202 632–7003 

Fax: 202 632–7066 

RIN: 3141–AA27 

BILLING CODE 7565–01–S 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5
79708 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / The Regulatory Plan 

POSTAL REGULATORY COMMISSION 

(PRC) 

Statement of Regulatory Priorities 

The Postal Regulatory Commission 

serves as the primary regulator of the 

United States Postal Service. Its primary 

mission is to ensure accountability and 

transparency of the Postal Service to 

Congress, stakeholders, and the general 

public on issues such as financial 

operations, pricing policies, and 

delivery performance. 

In fiscal year 2011, the Commission 

will evaluate its existing regulations 

with the goal of improving and 

streamlining them to ensure that the 

Postal Service is in full compliance with 

applicable law. The Commission’s 

principal regulatory priority for fiscal 

year 2011 is to complete its review of 

proposed exceptions to recently adopted 

service performance measurement 

reporting requirements. 

PRC 

FINAL RULE STAGE 

174. ∑ PERIODIC REPORTING 

EXCEPTIONS 

Priority: 

Other Significant 

Legal Authority: 

39 USC 3652(a)(2)(B); 39 USC 3652(e); 

39 USC 3651 

CFR Citation: 

Not Yet Determined 

Legal Deadline: 

None 

Abstract: 

Pursuant to section 3652(e) of the 

Postal Accountability and Enhancement 

Act (PAEA) of 2006, the Commission 

has completed a comprehensive 

rulemaking addressing service measure 

performance and customer satisfaction 

reporting on the part of the United 

States Postal Service (Postal Service). 

These regulations allow the Postal 

Service to request that a product or 

component of a product be excluded 

from service performance measurement 

reporting if certain conditions (set out 

in the regulations) are met. The 

Commission has established rulemaking 

to address the Postal Service’s formal 

mail request for semi-permanent 

exceptions for service performance 

measurement of Standard Mail High 

Density, Saturation, and Ca Route 

Parcels, Inbound International Surface 

Parcel Post (at Universal Postal Union 

Rates), hard-copy Address Correction 

Service, various Special Services, 

within County Periodicals, and various 

negotiated service agreements. 

This rulemaking will assess the need 

to balance the responsibilities of the 

Commission and the Postal Service 

under the PAEA with time and 

resource constraints, and thereby, 

advance an efficient implementation of 

the 2006 law. 

Statement of Need: 

The Commission recognizes that 

exceptions to new service performance 

reporting requirements may be 

appropriate, assuming certain 

conditions are met. Therefore, it has 

established this rulemaking to address 

the Postal Service’s request for 

exceptions for certain products and 

services. 

Summary of Legal Basis: 

39 U.S.C. 3652(a)(2)(B) and 3651 

require the United States Postal Service 

to prepare and submit to the Postal 

Regulatory Commission periodic 

reports, which provide, in part, 

measures of the quality of service 

afforded each market dominant 

product. Practical implementation of 

these provisions requires that the Postal 

Service be given an opportunity to 

apply for certain exceptions to new 

reporting requirements under certain 

conditions. This rulemaking allows the 

Postal Service’s proposed exceptions to 

be considered. 

Alternatives: 

There are no alternative methods of 

complying with the requirements of 39 

U.S.C. 3652(a)(2)(B) and 3651 other 

than by issuing regulations. 

Anticipated Cost and Benefits: 

The United States Postal Service is 

expected to incur somewhat fewer costs 

with respect to measuring and reporting 

if its proposal is adopted, in whole or 

in part. The Commission will not incur 

any additional costs to review Postal 

Service reports and may incur fewer 

costs. 

Risks: 

There are no known risks to this 

regulatory action. 

Timetable: 

Action Date FR Cite 

NPRM 07/06/10 75 FR 38757 

NPRM Comment 

Period End 

07/16/10 

Final Action 12/00/10 

Regulatory Flexibility Analysis 

Required: 

No 

Government Levels Affected: 

Federal 

URL For More Information: 

www.prc.gov (usually linked to the 

program office) 

URL For Public Comments: 

www.regulations.gov 

Agency Contact: 

Stephen L Sharfman 

General Counsel 

Postal Regulatory Commission 

Suite 200 

901 New York Avenue NW 

Washington, DC 20268–0001 

Phone: 202 789–6820 

Fax: 202 789–6861 

Email: stephen.sharfman@prc.gov 

RIN: 3211–AA06 

BILLING CODE 7710–FW–S 


jlentini on DSKJ8SOYB1PROD with PROPOSALS5