[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Unknown Section]
[Pages 79459-79708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30473]
[[Page 79459]]
DEPARTMENT OF AGRICULTURE
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 0579-AC03 Final Rule Stage
Authorized for Importation Pending Pest Risk Analysis
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 0584-AD87 Proposed Rule
Energy Act of 2008 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, 0584-AD60 Final Rule Stage
and Runaway Children for Free Meals in the NSLP, SBP, and SMP
15 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC 0584-AD77 Final Rule Stage
Food Packages
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 0583-AD39 Proposed Rule
Foreign Establishment Certifications; Deletion of Streamlined Inspection Procedures for Canadian Stage
Product
20 Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the 0583-AD41 Proposed Rule
Requirements for Official Export Inspection Marks, Devices, and Certificates Stage
21 Performance Standards for the Production of Processed Meat and Poultry Products; Control of 0583-AC46 Final Rule Stage
Listeria Monocytogenes in Ready-To-Eat Meat and Poultry Products
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
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DEPARTMENT OF COMMERCE
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 0648-AV51 Final Rule Stage
Fishing or Bycatch of Protected Living Marine Resources
[[Page 79460]]
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 0648-AY68 Final Rule Stage
Rationalization Program
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DEPARTMENT OF DEFENSE
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
31 Voluntary Education Programs 0790-AI50 Final Rule Stage
32 TRICARE; Reimbursement of Sole Community Hospitals 0720-AB41 Proposed Rule
Stage
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DEPARTMENT OF EDUCATION
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
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DEPARTMENT OF ENERGY
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
41 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information 0991-AB57 Final Rule Stage
Technology for Economic and Clinical Health Act
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
[[Page 79461]]
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 0910-AF27 Final Rule Stage
Requirements; Records and Reports; and Quality Factors
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 0938-AQ24 Proposed Rule
FY 2012 Rates and to the Long-Term Care Hospital PPS and RY 2012 Rates (CMS-1518-P) 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 0938-AQ26 Proposed Rule
Payment System for CY 2012 (CMS-1525-P) 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 0985-AA07 Proposed Rule
Affordable Care Act Stage
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DEPARTMENT OF HOMELAND SECURITY
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 1601-AA34 Final Rule Stage
Departure; United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT)
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 1615-AB71 Proposed Rule
to Numerical Limitations Stage
65 Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and 1615-AB89 Proposed Rule
Withholding of Removal Stage
66 New Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T 1615-AA59 Final Rule Stage
Nonimmigrant Status
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- 1615-AB75 Final Rule Stage
Term Investor Status
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
[[Page 79462]]
73 Inspection of Towing Vessels 1625-AB06 Proposed Rule
Stage
74 Assessment Framework and Organizational Restatement Regarding Preemption for Certain Regulations 1625-AB32 Proposed Rule
Issued by the Coast Guard 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 1651-AA72 Final Rule Stage
(ESTA) Program
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 1652-AA53 Proposed Rule
Security Program 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 1653-AA56 Final Rule Stage
STEM Degrees and Expanding the CAP-GAP Relief for All F-1 Students With Pending H-1B Petitions
90 Update of FEMA's Public Assistance Regulations 1660-AA51 Proposed Rule
Stage
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DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
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DEPARTMENT OF JUSTICE
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
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93 National Standards to Prevent, Detect, and Respond to Prison Rape 1105-AB34 Proposed Rule
Stage
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DEPARTMENT OF LABOR
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
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94 Construction Contractor Affirmative Action Requirements 1250-AA01 Proposed Rule
Stage
[[Page 79463]]
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 1205-AB58 Proposed Rule
Agriculture or Registered Nursing in the United States (H-2B Workers) 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 1218-AC49 Proposed Rule
System Stage
112 Hazard Communication 1218-AC20 Final Rule Stage
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DEPARTMENT OF TRANSPORTATION
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
[[Page 79464]]
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
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ENVIRONMENTAL PROTECTION AGENCY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 2060-AO72 Proposed Rule
Sulfur Stage
133 National Emission Standards for Hazardous Air Pollutants for Coal- and Oil-Fired Electric Utility 2060-AP52 Proposed Rule
Steam Generating Units 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 2070-AJ32 Proposed Rule
by Producers of Plant-Incorporated Protectants (PIPs) 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 2050-AG60 Proposed Rule
(CO2) Injectate in Geological Sequestration Activities Stage
143 Financial Responsibility Requirements Under CERCLA Section 108(b) for Classes of Facilities in the 2050-AG61 Proposed Rule
Hard Rock Mining Industry Stage
144 NPDES Permit Requirements for Municipal Sanitary and Combined Sewer Collection Systems, Municipal 2040-AD02 Proposed Rule
Satellite Collection Systems, Sanitary Sewer Overflows, and Peak Excess Flow Treatment Facilities 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
[[Page 79465]]
147 National Pollutant Discharge Elimination System (NPDES) Permit Regulations for New Dischargers and 2040-AF17 Proposed Rule
the Appropriate Use of Offsets With Regard to Water Quality Permitting 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, 2060-AM44 Final Rule Stage
and Institutional Boilers
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, 2060-AQ25 Final Rule Stage
and Institutional Boilers and Process Heaters
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
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EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
157 Regulations To Implement the Equal Employment Provisions of the Americans With Disabilities Act 3046-AA85 Final Rule Stage
Amendments Act
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NATIONAL ARCHIVES AND RECORDS ADMINISTRATION
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
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158 Office of Government Information Services 3095-AB62 Proposed Rule
Stage
159 Declassification of National Security Information 3095-AB64 Proposed Rule
Stage
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SMALL BUSINESS ADMINISTRATION
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 3245-AF53 Final Rule Stage
Determination
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
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SOCIAL SECURITY ADMINISTRATION
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
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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
[[Page 79466]]
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 Income-Related Monthly 0960-AH06 Final Rule Stage
Adjustments Amounts to Medicare Part B Premiums (3574F)
170 Amendments to Regulations Regarding Withdrawals of Applications and Voluntary Suspension of 0960-AH07 Final Rule Stage
Benefits (3573I)
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CONSUMER PRODUCT SAFETY COMMISSION
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
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171 Testing, Certification, and Labeling of Certain Consumer Products 3041-AC71 Final Rule Stage
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NATIONAL INDIAN GAMING COMMISSION
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
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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
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POSTAL REGULATORY COMMISSION
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
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174 Periodic Reporting Exceptions 3211-AA06 Final Rule Stage
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[FR Doc. 2010-30473 Filed 12-17-10;8:45 am]
BILLING CODE 6820-27-S
<###DOC>
[[Page 79467]]
<###DOC>
DEPARTMENT OF AGRICULTURE (USDA)
<###DOC>
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 non-
timber 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 cost-effective manner. Regulations will
be revised to address emerging food safety challenges,
streamlined to remove excessively prescriptive regulations,
and updated to be made consistent with hazard analysis and
critical control point principles. 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
[[Page 79468]]
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 Single-Ingredient Products and Ground or
[[Page 79469]]
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
Federal-State 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
[[Page 79470]]
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 self-sustaining, 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
[[Page 79471]]
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, forest-based
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 Business-Cooperative 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
[[Page 79472]]
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.
_______________________________________________________________________
<###DOC>
USDA--Agricultural Marketing Service (AMS)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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
[[Page 79473]]
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: [email protected]
RIN: 0581-AD07
_______________________________________________________________________
<###DOC>
USDA--AMS
-----------
FINAL RULE STAGE
-----------
<###DOC>
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
[[Page 79474]]
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: [email protected]
RIN: 0581-AC87
_______________________________________________________________________
<###DOC>
USDA--Animal and Plant Health Inspection Service (APHIS)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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
_______________________________________________________________________
<###DOC>
USDA--APHIS
<###DOC>
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
[[Page 79475]]
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
_______________________________________________________________________
<###DOC>
USDA--APHIS
<###DOC>
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.
[[Page 79476]]
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
_______________________________________________________________________
<###DOC>
USDA--APHIS
<###DOC>
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.
[[Page 79477]]
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
_______________________________________________________________________
<###DOC>
USDA--APHIS
-----------
FINAL RULE STAGE
-----------
<###DOC>
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.
[[Page 79478]]
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
_______________________________________________________________________
<###DOC>
USDA--Rural Housing Service (RHS)
-----------
FINAL RULE STAGE
-----------
<###DOC>
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
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: [email protected]
Related RIN: Merged with 0575-AC24
RIN: 0575-AC13
_______________________________________________________________________
<###DOC>
USDA--Grain Inspection, Packers and Stockyards Administration (GIPSA)
-----------
FINAL RULE STAGE
-----------
<###DOC>
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
[[Page 79479]]
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
[[Page 79480]]
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: [email protected]
RIN: 0580-AB07
_______________________________________________________________________
<###DOC>
USDA--Food and Nutrition Service (FNS)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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-to-face 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: [email protected]
RIN: 0584-AD87
_______________________________________________________________________
<###DOC>
USDA--FNS
<###DOC>
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
[[Page 79481]]
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: [email protected]
RIN: 0584-AD88
_______________________________________________________________________
<###DOC>
USDA--FNS
<###DOC>
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.
[[Page 79482]]
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: [email protected]
RIN: 0584-AD96
_______________________________________________________________________
<###DOC>
USDA--FNS
-----------
FINAL RULE STAGE
-----------
<###DOC>
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 non-program 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
[[Page 79483]]
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: [email protected]
Related RIN: Merged with 0584-AC94
RIN: 0584-AC24
_______________________________________________________________________
<###DOC>
USDA--FNS
<###DOC>
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
McKinney-Vento Homeless Assistance Act; (2) a runaway served by grant
programs under the Runaway and Homeless Youth Act; or (3) migratory as
defined in 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: [email protected]
Related RIN: Merged with 0584-AD62
RIN: 0584-AD60
[[Page 79484]]
_______________________________________________________________________
<###DOC>
USDA--FNS
<###DOC>
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 long-term 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: [email protected]
RIN: 0584-AD77
[[Page 79485]]
_______________________________________________________________________
<###DOC>
USDA--Food Safety and Inspection Service (FSIS)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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 cost-
benefit analysis to evaluate the potential economic impacts of several
alternatives on the public, egg products industry, and FSIS. These
alternatives include: (1) Taking no regulatory action; (2) requiring
all inspected egg products plants to develop, adopt, and implement
written sanitation SOPs and HACCP plans; and (3) converting to a
lethality-based pathogen reduction performance standard many of the
current highly prescriptive egg products processing requirements. The
team will consider the effects of a uniform, across-the-board standard
for all egg products; a performance standard based on the relative risk
of different classes of egg products; and a performance standard based
on the relative risks to public health of different production
processes.
Anticipated Cost and Benefits:
FSIS is analyzing the potential costs of this proposed rulemaking to
industry, FSIS, and other Federal agencies, State and local
governments, small entities, and foreign countries. The expected costs
to industry will depend on a number of factors. These costs include the
required lethality, or level of pathogen reduction, and the cost of
HACCP plan and sanitation SOP development, implementation, and
associated employee training. The pathogen reduction costs will depend
on the amount of reduction sought and 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
[[Page 79486]]
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: [email protected]
RIN: 0583-AC58
_______________________________________________________________________
<###DOC>
USDA--FSIS
<###DOC>
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
[[Page 79487]]
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: [email protected]
RIN: 0583-AD32
_______________________________________________________________________
<###DOC>
USDA--FSIS
<###DOC>
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
_______________________________________________________________________
<###DOC>
USDA--FSIS
<###DOC>
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
[[Page 79488]]
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, Web-based 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
_______________________________________________________________________
<###DOC>
USDA--FSIS
<###DOC>
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, Web-based inspection
information system. The current export application and
[[Page 79489]]
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
_______________________________________________________________________
<###DOC>
USDA--FSIS
-----------
FINAL RULE STAGE
-----------
<###DOC>
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, science-based food safety processing procedures
and controls, while providing objective, measurable standards that can
be verified by Agency inspectional oversight. This set of performance
standards will include and be consistent with standards already in
place for certain ready-to-eat meat and poultry products.
Statement of Need:
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
[[Page 79490]]
the safety of these products; give establishments the incentive and
flexibility to adopt innovative, science-based food safety processing
procedures and controls; and provide objective, measurable standards
that can be verified by Agency oversight.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the
Poultry Product Inspection Act (21 U.S.C. 451 to 470), FSIS issues
regulations governing the production of meat and poultry products
prepared for distribution in commerce. The regulations, along with FSIS
inspection programs, are designed to ensure that meat and poultry
products are safe, not adulterated, and properly marked, labeled, and
packaged.
Alternatives:
As an alternative to all of the proposed requirements, FSIS considered
taking no action. As alternatives to the proposed performance standard
requirements, FSIS considered end-product testing and requiring ``use-
by'' date labeling on ready-to-eat products.
Anticipated Cost and Benefits:
Benefits are expected to result from 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: [email protected]
RIN: 0583-AC46
_______________________________________________________________________
<###DOC>
USDA--FSIS
<###DOC>
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
[[Page 79491]]
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: [email protected]
RIN: 0583-AC60
_______________________________________________________________________
<###DOC>
USDA--FSIS
<###DOC>
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
[[Page 79492]]
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: [email protected]
RIN: 0583-AD34
_______________________________________________________________________
<###DOC>
USDA--FSIS
<###DOC>
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 Federal-
State 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 State-inspection 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
[[Page 79493]]
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 State-inspected 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: [email protected]
RIN: 0583-AD37
_______________________________________________________________________
<###DOC>
USDA--Rural Business-Cooperative Service (RBS)
-----------
FINAL RULE STAGE
-----------
<###DOC>
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
[[Page 79494]]
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: [email protected]
RIN: 0570-AA79
_______________________________________________________________________
<###DOC>
USDA--Rural Utilities Service (RUS)
-----------
FINAL RULE STAGE
-----------
<###DOC>
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
[[Page 79495]]
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: [email protected]
RIN: 0572-AC06
BILLING CODE 3410-90-S
[[Page 79496]]
<###DOC>
DEPARTMENT OF COMMERCE (DOC)
<###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
Cabinet-level 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,
[[Page 79497]]
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 science-based policy
advice on options to deal with very long-term (decadal to centennial)
changes in the environment; and advancing and improving short-term
warning and forecast services for the entire environment.
Magnuson-Stevens 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 Magnuson-Stevens 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 Magnuson-Stevens Fishery Conservation and Management
Act, as reauthorized in 2006. The first action may be of
[[Page 79498]]
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, end-uses, 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
[[Page 79499]]
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, end-uses, 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.
[[Page 79500]]
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 export-promotion 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>
DOC--National Oceanic and Atmospheric Administration (NOAA)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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
[[Page 79501]]
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: [email protected]
RIN: 0648-AY54
_______________________________________________________________________
<###DOC>
DOC--NOAA
-----------
FINAL RULE STAGE
-----------
<###DOC>
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.
[[Page 79502]]
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: [email protected]
Related RIN: Related to 0648-AV23
RIN: 0648-AV51
_______________________________________________________________________
<###DOC>
DOC--NOAA
<###DOC>
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
upper-Cook Inlet, north of a line at 60[deg] 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[deg] 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: [email protected]
RIN: 0648-AX50
_______________________________________________________________________
<###DOC>
DOC--NOAA
<###DOC>
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
[[Page 79503]]
(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: [email protected]
Related RIN: Related to 0648-AX98
RIN: 0648-AY68
BILLING CODE 3510-12-S
[[Page 79504]]
<###DOC>
DEPARTMENT OF DEFENSE (DOD)
<###DOC>
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, cost-effective, 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;
[[Page 79505]]
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
[[Page 79506]]
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 Post-9/11 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 TRICARE-eligible employees to not enroll, or to
terminate enrollment, in an employer-offered 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
[[Page 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.
_______________________________________________________________________
<###DOC>
DOD--Office of the Secretary (OS)
-----------
FINAL RULE STAGE
-----------
<###DOC>
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,
instructor-led courses offered on-installation and off-installation, as
well as via distance learning; 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; 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,
instructor-led courses offered on-installation and off-installation, as
well as via distance learning; 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; 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
[[Page 79508]]
Agency Contact:
Kerrie Tucker
Department of Defense
Office of the Secretary
Defense Pentagon
Washington, DC 20301
Phone: 703 602-4949
RIN: 0790-AI50
_______________________________________________________________________
<###DOC>
DOD--Office of Assistant Secretary for Health Affairs (DODOASHA)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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
[[Page 79509]]
<###DOC>
DEPARTMENT OF EDUCATION (ED)
<###DOC>
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-for-profit
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,
community-based 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
[[Page 79510]]
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.
_______________________________________________________________________
<###DOC>
ED--Office of Postsecondary Education (OPE)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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: [email protected]
RIN: 1840-AD05
[[Page 79511]]
_______________________________________________________________________
<###DOC>
ED--OPE
-----------
FINAL RULE STAGE
-----------
<###DOC>
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: [email protected]
Fred Sellers
Department of Education
Office of Postsecondary Education
Room 8021
1990 K Street NW.
Washington, DC 20006
Phone: 202 502-7502
Email: [email protected]
Related RIN: Previously reported as 1840-AD04
RIN: 1840-AD06
BILLING CODE 4000-01-S
[[Page 79512]]
<###DOC>
DEPARTMENT OF ENERGY (DOE)
<###DOC>
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/appliance_standards/schedule_setting.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 life-cycle
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.
_______________________________________________________________________
<###DOC>
DOE--Energy Efficiency and Renewable Energy (EE)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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.
[[Page 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 [email protected].
URL For More Information:
www1.eere.energy.gov/buildings--standards/residential/clothes--
dryers.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: [email protected]
Related RIN: Merged with 1904-AB51, Related to 1904-AB76, Related to
1904-AC02
RIN: 1904-AA89
_______________________________________________________________________
<###DOC>
DOE--EE
<###DOC>
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.
[[Page 79514]]
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 [email protected].
URL For More Information:
www1.eere.energy.gov/buildings/appliance--standards/residential/
central--ac--hp.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: [email protected]
Related RIN: Related to 1904-AB94
RIN: 1904-AB47
_______________________________________________________________________
<###DOC>
DOE--EE
<###DOC>
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
[[Page 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 [email protected].
URL For More Information:
www1.eere.energy.gov/ buildings/appliance--standards/residential.
fluorescent--lamp.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: [email protected]
Related RIN: Related to 1904-AB77, Related to 1904-AA99
RIN: 1904-AB50
_______________________________________________________________________
<###DOC>
DOE--EE
<###DOC>
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/appliance--standards/residential/
furnaces--boilers.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: [email protected]
RIN: 1904-AC06
_______________________________________________________________________
<###DOC>
DOE--EE
<###DOC>
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.
[[Page 79516]]
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: [email protected]
RIN: 1904-AC11
_______________________________________________________________________
<###DOC>
DOE--EE
-----------
FINAL RULE STAGE
-----------
<###DOC>
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,
refrigerator-freezers, 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
[[Page 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
[email protected].
URL For More Information:
www.eere.energy.gov/buildings/appliance_standards/residential/
refrigerators_freezer.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: [email protected]
Related RIN: Related to 1904-AB92
RIN: 1904-AB79
BILLING CODE 6450-01-S
[[Page 79518]]
<###DOC>
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
<###DOC>
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.
[[Page 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 Long-Term 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 Long-Term 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
[[Page 79520]]
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 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.
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.
[[Page 79521]]
_______________________________________________________________________
<###DOC>
HHS--Office of the Secretary (OS)
-----------
FINAL RULE STAGE
-----------
<###DOC>
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 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.
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: [email protected]
RIN: 0991-AB57
_______________________________________________________________________
<###DOC>
HHS--Office of Consumer Information and Insurance Oversight (OCIIO)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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
[[Page 79522]]
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: [email protected]
RIN: 0950-AA07
_______________________________________________________________________
<###DOC>
HHS--OCIIO
-----------
FINAL RULE STAGE
-----------
<###DOC>
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: [email protected]
RIN: 0950-AA03
[[Page 79523]]
_______________________________________________________________________
<###DOC>
HHS--OCIIO
<###DOC>
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 re-enrollment. 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: [email protected]
RIN: 0950-AA08
_______________________________________________________________________
<###DOC>
HHS--Food and Drug Administration (FDA)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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
[[Page 79524]]
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: [email protected]
RIN: 0910-AC52
_______________________________________________________________________
<###DOC>
HHS--FDA
<###DOC>
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,
[[Page 79525]]
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: [email protected]
RIN: 0910-AG31
_______________________________________________________________________
<###DOC>
HHS--FDA
<###DOC>
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'
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.
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
[[Page 79526]]
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: [email protected]
RIN: 0910-AG41
_______________________________________________________________________
<###DOC>
HHS--FDA
<###DOC>
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: [email protected]
RIN: 0910-AG56
[[Page 79527]]
_______________________________________________________________________
<###DOC>
HHS--FDA
<###DOC>
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: [email protected]
RIN: 0910-AG57
_______________________________________________________________________
<###DOC>
HHS--FDA
-----------
FINAL RULE STAGE
-----------
<###DOC>
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
[[Page 79528]]
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 Anti-Drug 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: [email protected]
Related RIN: Split from 0910-AA04
RIN: 0910-AF27
[[Page 79529]]
_______________________________________________________________________
<###DOC>
HHS--FDA
<###DOC>
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: [email protected]
RIN: 0910-AF86
_______________________________________________________________________
<###DOC>
HHS--FDA
<###DOC>
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
[[Page 79530]]
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: [email protected]
RIN: 0910-AF88
_______________________________________________________________________
<###DOC>
HHS--Centers for Medicare & Medicaid Services (CMS)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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
[[Page 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: [email protected]
RIN: 0938-AQ09
_______________________________________________________________________
<###DOC>
HHS--CMS
<###DOC>
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: [email protected]
RIN: 0938-AQ22
_______________________________________________________________________
<###DOC>
HHS--CMS
<###DOC>
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
[[Page 79532]]
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: [email protected]
RIN: 0938-AQ24
_______________________________________________________________________
<###DOC>
HHS--CMS
<###DOC>
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: [email protected] gov
RIN: 0938-AQ25
_______________________________________________________________________
<###DOC>
HHS--CMS
<###DOC>
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 (CPI-U). 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
[[Page 79533]]
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: [email protected]
RIN: 0938-AQ26
_______________________________________________________________________
<###DOC>
HHS--CMS
-----------
FINAL RULE STAGE
-----------
<###DOC>
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 well-being 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: [email protected]
RIN: 0938-AQ02
_______________________________________________________________________
<###DOC>
HHS--Administration for Children and Families (ACF)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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
[[Page 79534]]
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: [email protected]
RIN: 0970-AC44
_______________________________________________________________________
<###DOC>
HHS--Administration on Aging (AOA)
-----------
PROPOSED RULE STAGE
-----------
<###DOC>
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.''
[[Page 79535]]
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
[[Page 79536]]
<###DOC>
DEPARTMENT OF HOMELAND SECURITY (DHS)
<###DOC>
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 multi-year transformation effort to
create a more efficient, effective, and customer-focused 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
[[Page 79537]]
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 highly-trained 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:
Pre-approval requirements, application requirements, land-based/
shipboard
[[Page 79538]]
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
[[Page 79539]]
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
Guam-CNMI 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 pre-
approved, 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
[[Page 79540]]
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' E-Verify 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
[[Page 79541]]
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 non-
aviation 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
[[Page 79542]]
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.
_______________________________________________________________________
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DHS--Office of the Secretary (OS)
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PROPOSED RULE STAGE
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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
[[Page 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: [email protected]
RIN: 1601-AA52
_______________________________________________________________________
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DHS--OS
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FINAL RULE STAGE
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