### ENVIRONMENTAL PROTEC TION AGENCY (EPA)

Statement of Priorities

Overview

Created in the wake of elevated concern abo ut environme n tal pollution, the U.S. Environmental Protection Agency opened its door s in downtown Washington, DC, on December 2, 1970. EPA was established to consolidate in one agency a variety of Federal research, monitoring, standard-setting, and enforcement activities to ensure environmental protection. EPA's missi on is to protect human health and to safeguard the natural environment—air, wate r, and land—upon which life depends. For the past 40 years, EPA has been working for a cleaner, heal thier environment for the American people. From regulating vehicle emissions to ensuring that drinking wate r is safe; from cleaning up toxic waste to assessing the safety of pesticides and chemicals; and from reducing greenhouse gas emissions to encouraging conservation, reuse, and recycling, EPA and its Federal, Stat e, local, and community partners have made enormous progress in protecting the Nation’s health and environment. Our air and water have both grown significantly cleaner in the last 40 years. The number of Americans receiving water that meets health standards went from 79 percent in 1993, to 92 percent in 2008. We have also reduced 60 percent of the dangerous air pollutants that cause smog, acid rain, lead poisoning, and more since the passage of the Clean Air Act in 1970. Innovations like smokestack scrubbers and catalytic converters in automobiles have helped this process. Today, new cars are 98 percent cleaner in terms of smog-forming pollutants than they were in 1970. Meanwhile, American families and businesses went from recycling about 10 percent of trash in 1980 to more than 33 percent in 2008. Eighty-three million tons of trash are recycled annually—the equivalent of cutting green house gas emissions from more than 33 million automobiles. Highlights of EPA's Regulatory Plan Despite the Nation’s progress, however, much work remains. The environmental problems the country faces today ar e often more complex than those of years past, and implementing solutions—both nationally and globally—are more challenging. Addre ssing global climate change will call for coordinated efforts to research alternative fuels and other emissi on reduction technologies and will require strong partnerships across many economic sectors and around the world. Increased energy consumption and higher costs underscore the need to promote alternativ e energy sources and invest in new technologies. EPA and States face serious challenges in improving and maintaining the Nation’s drinking water and wastewater infrastructure, and both are seeking innov ative ways to fund needed repairs and construction. EPA remains committed to working with global partners to advance shared priorities, not only by adapting to climate change, but also in ensuring national secu rity, facilitating commerce, promoting sustainable development, protecting vulnerable populations, and engaging diplomatically around the world. Deepwater BP Oil Spill EPA responded swiftly and transp arently to the Deepwater BP oil spill in the Gulf of Mexico. The Agency ha s b een working with local, State, and Fede ral response partners to provide sampling and realtime monitoring of the air, water, and sediment alon g the Gulf Coast. These efforts are intended to help States and other Federal agencies understand the immediate and long-term impacts of oil contamination and to ensure that residents in affected areas have acce ss to information about the quality of their water. As part of its ongoing response, the Agency has developed new ways to provide the public with the latest data and information. EPA’s em ergency response site ( www.epa.gov/bpspill ) has offered downloadable files with data on air, wate r, sedime nt, and waste conditions gathered since April 28th, just days after the spill.

### This spill has seriously affected the ecologica l and economic health of the Gulf Coast communities. Following the emergency response with a sustained, effective recovery and rebuilding effort will require significant commitments of resources, scientific and technical expertise, and coordination with a range of partners in the months and years ahead. Seven Guiding Priorities The Deepwater BP oil spill and other challenges inspire the Agency and drive its commitment to excellent perf o rmance and strong, measurable results. EPA is committed to carrying out its mission while respecting its core values of science, transparency, and t he rule of law. Effective, consistent enforcement is critical to achieving the human-health and environmental benefits expected from our environmental laws. To guide the Agency’s efforts in 2011 and subs equent years, Administrator Lisa P. Jackson has established seven guiding priorities. 1. Taking Action on Climate Change In 2009, EPA finalized an endangerment finding on greenhouse gases; issued the firs t national rules to redu ce g reenhouse gas emissions under the Clean Air Act; and initiated a national reporting system for greenhouse gas emissions. Wh ile EPA stands ready to help Congres s craft strong, science-based climate legislation that addresses t he spectrum of issues, the Agency will deploy existing regulatory tools as they are available and warranted. Using the Cl ean Air Act, EPA will finalize mobile source rules and provide a framework for continued improvements in that sector. In 2011, EPA will further develop the national reporting system for greenhouse gases to enable the agency to receive, quality-assure, and verify data submitted electronically from 10,000 to 15, 000 covered facilities. EPA will also continue to develop common-sense solutions for reducing greenhouse gas emissions from large stationary sources like power plants. In all of this , EPA is committed to recognizing that climate change affect s other parts of its core mission.

Greenhouse Gas Emissions Standards for Automobiles. Last year, EPA took the firs t Federal regulatory steps to address the problem of global c limate change by requiring industries to report their greenhouse gas emissions, and by issuing regulations that reduce greenhouse emissions from cars and light trucks and increase the Nation's use of renewab le fuels. Transportation sources emitted 28 percent of all U.S. greenhouse gas emissions in 2007 and have been the fastest-gr owing source of those emissions since 1990. This year EPA is taking another major step by proposing to set national emissions standards under section 202 of the Clean Air Act to control greenhouse gas emissions from heavy-duty trucks and buses.

Prevention of Significant Deterioration. In Janu ary 2011, EPA will begin im plementing its Prevention of Significant Deterioration and title V Greenhouse Gas Tailoring rule. EPA issued a final rule in May 2010 that establishes a common sense approach to ad dressing greenhouse gas emissions from stationary sources under the Clean Air Act (CAA) permitting programs. This final rule sets thresholds for greenhouse gas (GHG) emissions that define when permits under the New Source Review Prevention of Significant Deterioration (PSD) and title V Operating Permit pr ograms are required for new and existing industrial facilities. The rule “tailors” the requirements of these CAA permitting programs to limit which facilities will be required to obtain PSD and title V permits. 2. Improving Air Quality Since passage of the Clean Air Act Amendments in 1990, nationwide air quality has improved significantly for the six criteria ai r pollut ants for which there are national ambient air quality standards. Despite this progress, about 127 million Americans lived in counties with air considered unhealthy in 2008. Long-term exposure to air pollution can caus e cancer and damage to the immune, neurological, reproductive, cardiovascular, and respiratory systems.

### Review Air Quality Standards. Despite progress, millions of Americans still live in areas that exceed one or more of the national standards. Ground-level oz one and particle pollution still present challenges in many areas of the country. This year's regulatory plan describes efforts to review the primary National Ambient Air Quality Standards (NAAQS) for carbon monox ide, lead, and particulates. In addition, the Plan includes a joint review of the secondary N AAQS for oxides of nitrogen and oxides of sulfur. Replacing the Clean Air Interstate Rule. In the spri ng of 2011, E PA expects to complete and begin implementing a rule to replace the Transport Ru le that was remanded by the courts in 2008. Strengthening the standards and decr easing the emissions that contribut e to interstate transport of air pollution will help many areas of the country attain t he standards and achieve si gnificant improvements in public health. Cleaner Air from Improved Technology

. EPA continues to ad dre ss toxic air pollution under authority of the Clean Air Act Amendments of 1990. The centerpiec e of this effort is the "Maximum Achievable Control Technology" (MACT) program, which requires t hat all major sources of a given type use emission controls that better reflect the current state of t he art. This year's regulatory plan describes MACT standards under development for elec tric utility steam-generating units. 3. Assuring the Safety of Chemicals One of EPA’s highest priorities is to make significant and long overdue progre ss in assuring the safety of chemi c als. On September 29, 2009, Administ rator Jackson announced clear principles to guide Congress in writing a new chemical risk managem ent law that will fix the weaknesses in Toxic Substances Control Act (TSCA). EPA is shifting it s focus to addressing high-concern chemicals and filling data gaps on widely produced chemicals in co mmerce. In 2011, EPA will aggressively assess and manage the risks of chemicals used in co nsumer products, and the workplace.
Management of Chemical Risks. EPA’s Adminis t rator has highlighted the need to strengthen EPA’s chemical management program as one of her top prio rities. Using sound science as a compass, the mission of the Office of Chemical Safety and Polluti on Prevention (OCSPP) is to protect individuals, families, and the environment from potential risks of pesticides and other chemicals. In its implementation of these programs, OCSPP uses several different stat utory authorities, including the Federal Insecticide, Fungicide, and Rodenticide Act, the Federal Food, Dr ug, and Cosmetic Act, the Toxic Substances Control Act (TSCA) and the Pollution Prevention Act, as we ll as collaborative and voluntary activities.
Enhancing EPA’s Current Chemicals Managem ent Program under TSCA. As part of this comp re hensive effort, EPA has developed plans on spec ific chemicals, which ou tline the concerns that each chemical may present and specific actions the Agency will take to address those concerns. The Agency considers a range of actions to address potential risks, including utilizing for the first time the TSCA section 5(b)(4) authority to list chemicals of concern. EPA also intends to propose several regulatory actions under TSCA to gather additional in formation on nanoscale chemical materials, which will help the Agency assess the safety of nanoscale chemicals. EPA is also taking a number of steps to provide the public with greater access to chemical information, which includes increased web access to TSCA data and new policies for the review of conf idential business information (CBI) claims for substantial risk and health and safety studies.
Addressing Concerns with Legacy Chemicals – Lead and Me rcu ry. EPA is continuing its efforts to combat childhood lead poisoning through implementati on of the Lead Renovation, Repair, and Painting (RRP) rule, which includes consideration of a proposed rule to require that renovation firms perform dust wipe testing after certain renovations and provide the results of the testing to the owners and occupants of the building. EPA also is developing a number of actions to further reduce the use of mercury in a range of products, including switches, relays, and certain measuring devices.
Protecting Subjects in Human Research involving Pestic ides. On June 18, 2010, EPA settled a lawsuit over its 200 6 regulation that established protections for subjects of human research involving

### pesticides. Under the settlement agreement, EPA agreed that by January 18, 2 011, it will propose to broaden the applicability of the 2006 rule to apply to re search involving intentional exposure of a human subject to “a pesticide,” without limitation as to the regulatory statutes under which the data might be submitted, considered, or relied upon. EPA also co mmitted to propose amendm ents to the rule that would, if finalized, disallow consent by an authorized representative of a test subject and that would require the Agency, in its reviews of covered hu man research, to document its ethics and science considerations.

Defining the Nature of Regulated Produ ction of Plant-Incorporat ed Protecta nts (PIPs). PIPs are pesticidal substances intended to be produced and used in living plants and the genetic material needed for their production. EPA regulates PIPs under FIFRA and FFDCA, including issuing experimental use permits and commercial registrations. However, thes e Acts and the current implementing regulations do not specifically address what constitutes the production of PIPs or what units are relevant for purposes of reporting amounts of PIPs produced. This has led to inconsistency and confusion in the registration of PIP-producing establishments and in the reporting of units of PIPs produced, which in turn has resulted in significant difficulties in terms of compliance and en forcement. EPA intends to propose regulations to clarify the legal requirements applicable to PIP products at various phases of production. This rule will benefit the public by ensuring that public health and the environment are adequately protected while reducing burden on the regulated community, ther eby potentially reducing costs for consumers. 4. Cleaning Up Its Communities

In 2009 EPA accelerated it s Superfund program and c onfronted signifi cant l ocal environmental challenges like the asbestos Public Health Emerge ncy in Libby, Montana and the coal ash spill in Kingston, Tennessee. Using all t he tools at its disposal, including enforcement and compliance efforts, EPA will continue to focus on making sa fer, healthier communities in 2011. EPA meets this priority by focusing on preparation for, prevention and response to chemical and oil spills, accidents, and emergencies; enhancement of homeland security; in creasing the beneficial use and recycling of secondary materials, the safe management of wa stes and cleaning up contaminated property and making it available for reuse. EPA carries out these missions in par tnership with other Federal agencies, states, tribes, local governments, communities, nongovernmental organizations, and the private sector. Several regulatory priorities for the upcoming fiscal year will promote stewardship and resource conservation and focus regulatory efforts on risk reduction and statutory compliance.

Financi a l Responsibility under Superfund. Section 108(b) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), establishes certain authorities concerning financial responsibility requirements. The Agency has ident ified classes of facilities within the Hard Rock mining industry as those for which financial res ponsibility requirements will be first developed. This proposal will establish requirements for financial responsibility, notification, and implementation.
Non-Hazardous Secondary Materials. The Agency has propo sed to define which non-hazardous secondary materials burned in combustion units are solid wastes under the Resource Conservation and Recovery Act (RCRA). This in turn will assist the Agency in determining whic h non-hazardous secondary materials will be subject to the emissions standards proposed under either section 112 or section 129 of the Clean Air Act (CAA). If the non-hazardous secondary material is considered a "solid waste," the unit that burns the non-hazardous secondary material would be subject to the CAA section 129 requirements, while if the non-hazardous secondary materials would not be considered a “solid waste,” it would be subject to the CAA section 112 requirements.
Geologic Sequestration. In 2008, the Safe Drinking Water Act Underground Injection Control Program proposed to create a ne w class of injecti on wells (C lass VI) for geological sequestration (GS) of carbon

### dioxide (CO2). EPA received numerous comments as king for clarification on how the Resource Conservation and Recovery Act (R CRA) hazardous waste requirement s apply to CO2 streams. EPA is now considering a proposed rule under RCRA to explore a number of options. 5. Protecting America’s Waters Despite considerable progress, America’s waters remain imperiled. Water quality and enforcement program s face complex challenges, from nutrient lo adings and stormwater runoff to invasive species and drinking water contaminants. These chal lenges demand both traditional and innovative strategies. Improving Water Quality. EPA plans to address challenging water quality issues in several rulemaki ng s during fiscal year 2011. Stormwater. First, EPA plans to propose a n ationa l rule to address stormwater discharges from new development and redevelopment and explore other regulatory improvements to its stormwater program. To address the degradation of water quality caused by stormwater discharges from impervious cover, EPA is exploring regulatory options, including establ ishing specific post construction requirements for stormwater discharges from, at a minimum, new development and redevelopment. Stormwater discharges from areas of impervious cover in devel oped areas are a significant contributor to water quality impairments in receiving waters. Sanitary Sewer Overflows. EPA is also considering proposing modification s to the NPDE S regulations as they apply to municipal sanitary sewer collecti on systems and sanitary sewe r overflows (SSOs) in order to better protect the environment and public hea lth from the harmful effects of sanitary sewer overflows and basement back ups. Some of the changes EPA is considering include establishing standard permit conditions for publicly owned treatme nt works (POTW) permits t hat specifically address sanitary sewer collection systems and SSOs, and clarifying the regulatory framework for applying NPDES permit conditions to municipal satellite collection sy stems. Municipal satellite collection systems are sanitary sewers owned or operated by a municipalit y that conveys wastewater to a POTW operated by a different municipality. Use of Offsets. EPA plans to propose a National Pollutant Discharge Elimination System permit regulation for new di schargers and the appropriate use of offsets with regard to water quality permitting. This action may consider how to be st clarify EPA's approach to permi tting new dischargers in order to ensure the protection of water quality under Clean Water Act and may examine options to address the appropriate and permissible use of offsets which ensu res that NPDES permits are protective of water quality standards. Additionally, EPA may examine opti ons for addressing new di schargers in impaired waters, both when a TMDL is in place and prior to TMDL issuance. Concentrated Animal Feeding Operati ons. In 2008, EPA amended the concentrated animal feeding operation (CAFO) re gulati on to require, among other things, CAFOs that discharge or propose to discharge to seek coverage under an NPDES permit. Under the authority of section 308 of the Clean Water Act, EPA is proposing a rule to collect facility information from all CAFOs which will provide a CAFO inventory and assist in implementing the 2008 CAFO rule. Cooling Water Intake Structures. EPA plans to pr opose s tandards for cooling water intakes for electric power plants and for other manufacturers who use large amounts of cooling water. The goal of the proposed rule will be to protect aquatic organisms from being killed or injured through impingement or entrainment. Improving Clean Water Act Enforcement. EPA has the primary responsibility to ensure that the Clean Water Act’s (CWA ) Natio nal Pollutant Discharge Elimi nation System (NPDES) program is effectively and consistently implemented across the country, thus ensuring that pu blic health and environmental

### protection goals of the CWA are met. EPA needs site-specific information to provide national NPDES program direction and oversight, to inform Congress and the public, and to better ensure protection of public health and the environment. EPA plans to propose an NPDES Electronic Reporting Rule that will seek to improve the EPA’s access to facility-specific information for the diverse universe of NPDESregulated sources of wastewater discharges. Electron ic reporting of NPDES information may be sought from NPDES permittees and/or States.
6. Expanding the Conversation on Environmentalism and Working for Environmental Justice.

Environmentalism has been described as a conv ersation that we all must have becau se it is about protecting people in the places they live, work, and raise families. In FY 2011, the Agency is focused on expanding the conversation to include new stakeholders and involve communities in more direct ways. In managing risk and in ensuring that environment al rules protect all Americ ans, EPA directs its efforts toward identifying and mitigating exposure s and other factors in our communities, schools, homes, and workplaces that might negatively impact human h ealth and environmental quality. A renewed focus is being placed on the continuing Environmental Justic e (EJ) efforts to address the environmental and public health concerns of minority, low income, tribal, and other disproportionately burdened communities and focus on improving environmental and public health protection in these communities. Environmental Justice in Rulemaking. In Ju ly 2010, EPA released an interim guidance document to help Agency staff includ e environ mental justice princi ples in its rulemaking process. The rulemaking guidance is an important and positive step toward meeting EPA Administrato r Lisa P. Jackson’s priority to work for environmental justice and protect the health and safety of communities who have been disproportionately impacted by pollu tion. In carrying out this mandate, EPA will also seek to ensure that such communities do not experience disproportionate economic impacts from its programs and regulations.

Children’s Health. The protection of vulnerable subpopulatio ns is one of the EPA’s top priorities, especially with regard to children. EPA’s revitalized Children’s Health Office is bringing a new energy to safeguarding children throu gh the entire Agency’s regulatory and en forcement efforts. In 2011, EPA will co-lead an interagency effort in integrating existing school programs including asthma, indoor air quality, chemical safety and management, green practices, and enhanced use of integrated pest management. 7. Building Strong State and Tribal Partnerships EPA's success depends more than ever on working with incr easingly capable and environmentally

con scious partners. The Agency works with the States and tribes, business and industry, nonprofit organizations, environmental groups, and educational inst itutions in a wide variety of collaborative efforts. Currently, more than 13,000 firms and other organi zations participate in EPA partnership programs. States and tribal nations bear important responsib ilities for the day-to-day mission of environmental protection, but declining tax revenues and fiscal challenges are pressuring State agencies and tribal governments to do more with fewer resources. EPA mu st do its part to support State and tribal capacity. Recognizing the Right of Tribes as Sovereign Nations. In FY 2009, EPA Administrator Jackson reaffirmed the Ag ency’ s Indian Policy, which recognizes that the United States has a unique legal relationship with tribal governments based on treaties, stat utes, executive orders, and court decisions. EPA recognizes the right of Tribes as sovereign governm ents to self-determination and acknowledges the federal government’s trust respon sibility to Tribes. In FY 2011, EPA and Tribes are focusing on drinking water, sanitation, schools, and properly managing solid and hazardous waste on tribal lands.

Conclusion

### These priorities will guide EPA’s work in t he years ahead. They are bu ilt around the challenges and opportunities inherent in our mission to protect human health and the environment for all Americans. This mission is carried out by respecti ng EPA’s core values of science, transparency, and the rule of law. Within these parameters, EPA carefu lly considers the impacts its regul atory actions will have on society.
Aggregate Costs and Benefits EPA has calculated a combined aggregate estima te of the cost s and benefits of regulations included in the regul atory plan. For the fiscal year 2009, EPA has been able to gather sufficient data on 5 of the 30 anticipated regulations to include them in an aggregat e estimate. For the remaining actions, costs and benefits have not yet been calculated for various reasons.
The regulations included in the aggregate estimate of costs and benefits are:

• Federal Transport Rule; • Combined Rulemaking for Industrial, Commercial, an d Institutional Boilers a nd Process Heaters at

Major Sources of HAP and Industrial, Commercial, and Institutional Boilers at Area Sources; • National Emission Standards for Hazardous Air Pollut ants for Majo r Sources: Industri al, Commercial &

Institutional Boilers and Process Heaters; • Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, and Painting

Program; and

• Crite ria and Standards for Cooling Wate r Intake Structures—Pha se II Remand.
EPA obtained aggregate estimate s of total costs and benefits assumi ng both a 3 percent discount rate and a 7 pe rce n t discount rate. One of the five r egulations (TSCA Lead Renovation) included costs estimates but provided no estimate of the monetized benef it of the rule. Given a 3 percent discount rate, benefits range from $144 billion to $349 billion. With a 7 percent discount rate , benefits range from $132 billion to $323 billion. Costs were relatively constan t, approximately $6 billion, r egardless of the discount rate. All values are 2008 dollars. For the two rule s that did not use a 2008 base year, values were converted using a GDP deflator.
These results should be considered with caution for a number of reasons. First, there are significant gaps in data. In general, the benefits e s timates reported above do not include values for benefits that have been quantified but not monetized and missing valu es for qualitative benefits, such as some human health benefits and ecosystem health improvements. Second, methodologies and types of costs/benefits considered are inconsistent, as are the units of analysis. Some of the costs/benefits are described as annualized values while other values are specific to one year. Third, problems with aggregation can arise from differing baselines. Finally, the ranges presented do not reflect the full range of uncertainty in the benefit and cost estimates for these rules.
Rules Expected to Affect Small Entities By better coordinating small business activi ties, EPA aims to improve its te chni cal assistance and outreach efforts, minimize burdens to small businesse s in its regulations, and simplify small businesses' participation in its voluntary programs. Actions t hat may affect small entities can be tracked on EPA’s Rulemaking Gateway (http://www.epa.gov/lawsregs/rulemaking/index.html) at any time. This Plan includes a number of rules that may be of particular interest to small entities:

• National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Com mercial, and Institutio nal Boilers (2060-AM44);

• National Emission Standards for Hazardous Air Pollu t ants for Maj or Sources: Industrial, Commercial, and Institutional Boilers and Process Heaters (2060-AQ25);

### • Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, and Painting Program (2070-AJ57)

• Stormwater Regulations Revision to Addres s Di scharg es from Developed Sites (2040-AF13).The 27 Actions Described in the Regulatory Plan

Title Regulation Identifier Number Rulemaking Stage

NPDES Electronic Reporting Rule 2020-AA47 Proposed Rule Stage NPDES Permit Requirements for Municipal Sanitary and Combined Sewer Collection Systems, Municipal Satellite Collection Systems, Sanitary Sewer Overflows, and Peak Excess Flow Treatment Facilities 2040-AD02 Proposed Rule Stage

Criteria and Standards for Cooling Water Intake Structures 2040-AE95 Proposed Rule Stage
Stormwater Regulations Revision To Address Discharges From Developed Sites 2040-AF13 Proposed Rule Stage National Pollutant Discharge Elimination System (NPDES) Permit Regulations for New Dischargers and the Appropriate Use of Offsets With Regard to Water Quality Permitting 2040-AF17 Proposed Rule Stage

Concentrated Animal Feeding Operations (CAFO) Information Collection Request Rule 2040-AF22 Proposed Rule Stage Hazardous Waste Management Systems: Identification and Listing of Hazardous Waste: Carbon Dioxide (CO2) Injectate in Geological Sequestration Activities 2050-AG60 Proposed Rule Stage

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

Identification of Non-Hazardous Secondary Materials That Are Solid Wastes 2050-AG44 Final Rule Stage
Review of the National Ambient Air Quality Standards for Carbon Monoxide 2060-AI43 Proposed Rule Stage
Review of the National Ambient Air Quality Standards for Particulate Matter 2060-AO47 Proposed Rule Stage Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of Sulfur 2060-AO72 Proposed Rule Stage

National Emission Standards for Hazardous Air Pollutants for Coal- and Oil-Fired Electric Utility Steam Generating Units 2060-AP52 Proposed Rule Stage

Control of Greenhouse Gas Emissions From Medium and Heavy-Duty Vehicles 2060-AP61 Proposed Rule Stage
Review of the National Ambient Air Quality Standards for Lead 2060-AQ44 Proposed Rule Stage
National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Commercial, and Institutional Boilers 2060-AM44 Final Rule Stage

Transport Rule (CAIR Replacement Rule) 2060-AP50 Final Rule Stage
Revision to Pb Ambient Air Monitoring Requirements 2060-AP77 Final Rule Stage Reconsideration of the 2008 Ozone Primary and Secondary National Ambient Air Quality Standards 2060-AP98 Final Rule Stage

Revisions to Motor Vehicle Fuel Economy Label 2060-AQ09 Final Rule Stage National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial, and Institutional Boilers and Process Heaters 2060-AQ25 Final Rule Stage

Regulations To Facilitate Compliance With the Federal Insecticide, Fungicide, and Rodenticide Act by Producers of Plant-Incorporated Protectants (PIPs) 2070-AJ32 Proposed Rule Stage

Mercury; Regulation of Use in Certain Products 2070-AJ46 Proposed Rule Stage
Nanoscale Materials; Reporting Under TSCA Section 8(a) 2070-AJ54 Proposed Rule Stage
Nanoscale Materials; Significant New Use Rule (SNUR) 2070-AJ67 Proposed Rule Stage Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides 2070-AJ76 Proposed Rule Stage

Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, and Painting Program 2070-AJ57 Final Rule Stage

Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance ( OECA ) RIN: 2020-AA47

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Title: NPDES Electronic Reporting Rule Abstract: The U.S. Environmental Protection Agency (EPA) has responsibility to ensure that the Clean Water Act’s (CWA) National Pollutant Discharge Elimination System (NPDES) program is effectively and consistently implemented across the country. This regulation would identify the essential information that EPA needs to receive electronically, primarily from NPDESpermittees with some data required from NPDES agencies (NPDES-authorized States, territories, and tribes) to manage the national NPDES permitting and enforcement program. Through this regulation, EPA seeks to ensure that such facility-specific information would be readily available, accurate, timely, and nationally consistent on the facilities that are regulated by the NPDES program. In the past, EPA primarily obtained this information from the Permit Compliance System (PCS). However, the evolution of the NPDES program since the inception of PCS has created an increasing need to better reflect a more complete picture of the NPDES program and the diverse universe of regulated sources. In addition, information technology has advanced significantly so that PCS no longer meets EPA’s national needs to manage the full scope of the NPDES program or the needs of individual States that use PCS to implement and enforce the NPDES program.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 40 CFR 123, 403, and 501 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: CWA secs 304(i) and 501(a), 33 USC 1314(i) and 1361(a) Legal Deadline: None

Regulatory Plan: Statement of Need: As the NPDES program and information technology have evolved in the past several decades, the Permit Compliance System (PCS), EPA's NPDES national data system, which has been in use since 1985, has become increasingly ineffective in meeting the full scope of EPA's and individual State's needs to manage, direct, oversee, and report on the implementation and enforcement of the NPDES program. Therefore, a NPDES component of EPA's existing Integrated Compliance Information System (ICIS), ICIS-NPDES, was designed and constructed based upon EPA and State input to manage data for the full breadth of the NPDES program. This rulemaking would identify essential NPDES-specific information EPA needs to receive from NPDES agencies (authorized States and tribes, as well as EPA Regions). This information will be managed by EPA in a format compatible with the new NPDES component of the Integrated Compliance Information System (ICIS) in order to better enable EPA to ensure the protection of public health and the environment, effectively manage the national NPDES permitting and enforcement program, identify and address environmental problems, and ultimately replace PCS. This action would be of interest primarily to NPDES permittees, NPDES-authorized states, and to the public at large, which would ultimately have increased access to this NPDES information.

Legal Basis: In 1972, Congress passed the Clean Water Act to "restore and maintain the chemical, physical, and biological integrity of the Nation's waters." 33 U.S.C. 1251(a). The Clean Water Act established a comprehensive program for protecting and restoring our Nation’s waters. The Clean Water Act prohibits the discharge of pollutants from a point source to waters of the United States except when authorized by a National Pollutant Discharge Elimination System (NPDES) permit. The Clean Water Act established the NPDES permit program to authorize and regulate the discharges of pollutants to waters of the United States. EPA has issued comprehensive regulations that implement the NPDES program at 40 CFR parts 122 to 125, 129 to 133, 136, and subpart N. Under the NPDES permit program, point sources subject to regulation may discharge pollutants to waters of the United States subject to the terms and conditions of an NPDES permit. With very few exceptions (40 CFR 122.3), point sources require NPDES permit authorization to discharge, including both municipal and industrial discharges. NPDES permit authorization may be provided under an individual NPDES permit, which is developed after a process initiated by a permit application (40 CFR 122.21), or under a general NPDES permit, which, among other things, applies to one or more categories of dischargers (e.g., oil and gas facilities, seafood processors) with the same or substantially similar types of operations and the same effluent limitations, operating conditions, or standards for sewage sludge use or disposal [40 CFR 122.28(a)(2)]. The U.S. Environmental Protection Agency has the primary responsibility to ensure that the NPDES program is effectively and consistently implemented across the country, thus ensuring that public health and environmental protection goals of the CWA are met. Many States and some territories have received authorization to implement and enforce the NPDES program, and EPA works with its State partners to ensure effective program implementation and enforcement. CWA section 304(i)(2) directs EPA to promulgate guidelines establishing the minimum procedural and other elements of a State, territory, or tribal NPDES program, including monitoring requirements, reporting requirements (including procedures to make information available to the public), enforcement provisions, and funding, personnel qualifications, and manpower requirements [CWA section 304(i)(2)]. EPA published NPDES State, territory, and tribal program regulations under CWA section 304(i)(2) at 40 CFR part 123. Among other things, the part 123 regulations specify NPDES program requirements for permitting, compliance evaluation programs, enforcement authority, sharing of information, transmission of information to EPA, and noncompliance and program reporting to EPA. This proposed rulemaking may add some specificity to those particular regulations regarding what NPDES information is required to be submitted to EPA by States and may modify other regulations to require electronic reporting of NPDES information by NPDES permittees to the States and EPA.

Alternatives: For this proposed rulemaking, EPA has determined that the need for EPA's receipt of such NPDES information exists. If, for whatever reason, electronic reporting by permittees is not a feasible option for certain NPDES information, the obvious alternative would be for EPA to require States to provide that information to EPA. The States already receive that information from the permittees, and therefore, they have the information that EPA seeks. Within the rulemaking process itself, various alternatives are under consideration based on the feasibility of particular electronic reporting options. For example, EPA may consider establishing requirements for electronic reporting of discharge monitoring reports by NPDES permittees. Under this proposed rulemaking, EPA may consider establishing similar requirements for any or all of the following types of NPDES information: Notices of intent to discharge (for facilities seeking coverage under general permits), permittinginformation (including permit applications), various program reports (e.g., pretreatment compliance reports from approved local pretreatment programs, annual reports from concentrated animal feeding operations, biosolids reports, sewage overflow incident reports, annual reports for pesticide applicators, annual reports for municipal storm water systems), and annual compliance certifications. Some States might also raise the possibility of supplying only summary-level information to EPA rather than facility-specific information to EPA. Based upon considerable experience, EPA considers such alternative non-facility-specific data to be insufficient to meet its needs, except in very particular situations or reports. One alternative that EPA may consider for rule implementation is whether third-party vendors may be better equipped to develop and modify such electronic reporting tools than EPA.

Costs and Benefits: The economic analysis for this proposed rulemaking has not yet been completed; therefore, the dollar values of estimated costs and benefits are not yet known. However, some generalizations can still be made regarding expectations. EPA anticipates that electronic reporting of discharge monitoring reports (DMRs) by NPDES permittees will provide significant data entry cost savings for States and EPA. These discharge monitoring reports are already required to be submitted by NPDES permittees to States and EPA, which in turn currently enter that information into the State NPDES data system or EPA's national NPDES data system. These discharge monitoring reports contain significant amounts of information regarding pollutants discharged, identified concentrations and quantities of pollutants, discharge locations, etc. Through electronic reporting by permittees, States, and EPA will no longer have associated data entry costs to enter this information. Electronic reporting by NPDES permittees of other NPDES information (such as notices of intent to discharge or various program reports) may also yield considerable data entry savings to the States and EPA. In addition, some States have been able to quantify savings by the permittees to electronically report their NPDES information using existing electronic reporting tools. Such savings are being examined in the economic analysis process for this rulemaking. Additional benefits of this rule will likely include improved transparency of information regarding the NPDES program, improved information regarding the national NPDES program, improved targeting of resources and enforcement based on identified program needs and noncompliance problems, and ultimately improved protection of public health and the environment. Some NPDES information will need to be reported by States to EPA; therefore, there will be some data entry costs associated with that information, but it will likely be far less than the savings that will be realized by States through electronic reporting by NPDES permittees. In addition, EPA will likely have sizable costs to develop tools for electronic reporting by permittees, as well as operation and maintenance costs associated with those tools.

Risks: Given the scope of this proposed rulemaking, the most significant risks associated with this effort may be those if EPA does not proceed with this rulemaking. At this point, EPA does not receive sufficient NPDES information from the States to be able to fully assess the implementation of the national NPDES program nor the smaller subprograms. Such information is not currently required by EPA from the States, and the lack of such reporting requirements perpetuates this problem. Furthermore, EPA does not have facility-specific information regarding most of the facilities regulated under the NPDES program, and therefore, EPA cannot easily identify potential implementation problems or noncompliance problems. This lack of information may adversely impact EPA's ability to better ensure the protection of public health and the environment, nationally and locally. A potential risk associated with this rule may involve EPA efforts to develop electronic reporting tools for use by permittees. The costs associated with the internal development of such tools, possibly for multiple types of NPDES information from various types of NPDES permittees, and the future costs of operation and maintenance may be substantial for EPA, possibly impacting the availability of funding for other purposes. Furthermore, EPA would also need to determine the feasibility of ensuring that the electronic tools can be flexible enough to meet State needs and work well with State data systems. Problems in the development and maintenance of these electronic tools could pose significant risks for the effective implementation of this rule. Timetable:
Action Date FR Cite Notice--Public Meeting 07/01/2010 75 FR 38068
NPRM 04/00/2011
Final Action 04/00/2012

Additional Information: SAN No. 5251

Regulatory Flexibility Analysis Required: No Government Levels Affected: State Small Entities Affected: No Federalism: Yes Energy Affected: No Agency Contact: Andrew Hudock Environmental Protection Agency Office of Enforcement and Compliance Assurance 2222A Washington , DC 20460 Phone: 202 564-6032 E-Mail: Hudock.Andrew@epamail.epa.gov Agency Contact: John Dombrowski Environmental Protection Agency Office of Enforcement and Compliance Assurance 2222A Washington , DC 20460Phone: 202 566-0742 E-Mail: Dombrowski.John@epamail.epa.gov

Environmental Protection Agency (EPA) Water ( WATER ) RIN: 2040-AD02

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Title: NPDES Permit Requirements for Municipal Sanitary and Combined Sewer Collection Systems, Municipal Satellite Collection Systems, Sanitary Sewer Overflows, and Peak Excess Flow Treatment Facilities Abstract: EPA will develop a notice of proposed rulemaking outlining a broad-based regulatory framework for sanitary sewer collection systems under the NPDES program. The Agency is considering proposing standard permit conditions for inclusion in permits for publicly owned treatment works (POTWs) and municipal sanitary sewer collection systems. The standard requirements would address reporting, public notification, and recordkeeping requirements for sanitary sewer overflows (SSOs), capacity assurance, management, operation, and maintenance requirements for municipal sanitary sewer collection systems; and a prohibition on SSOs. The Agency is also considering proposing a regulatory framework for applying NPDES permit conditions, including applicable standard permit conditions, to municipal satellite collection systems. Municipal satellite collection systems are sanitary sewers owned or operated by a municipality that conveys wastewater to a POTW operated by a different municipality.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: 40 CFR 122.38; 40 CFR 122.41; 40 CFR 122.42 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 33 USC 1311 CWA 301; 33 USC 1314 CWA 304; 33 USC 1318 CWA 308; 33 USC 1342 CWA 402; 33 USC 1361 CWA 501(a) Legal Deadline: None

Regulatory Plan: Statement of Need: EPA is developing a rule to modify the National Pollutant Discharge Elimination System regulations as they apply to municipal sanitary sewer collection systems and sanitary sewer overflows in order to better protect the environment and public health from the harmful effects of sanitary sewer overflows and basement back ups.

Legal Basis: The Agency is undertaking this effort to help advance the Clean Water Act objective to restore and maintain the chemical, physical, and biological integrity of the Nation's waters (CWA, sec. 101 (a)).

Alternatives: EPA will consider a variety of options during the rulemaking process.

Costs and Benefits: EPA will consider anticipated costs and benefits during the rulemaking process.

Risks: EPA will consider potential risks during the rulemaking process. Timetable:
Action Date FR Cite Notice--Public Meeting 06/01/2010 75 FR 30395
NPRM 11/00/2011
Final Action 11/00/2012

Additional Information: EPA Docket information: EPA–HQ–OW– 2010–0464

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; Local; State; Tribal Small Entities Affected: Governmental Jurisdictions Federalism: Undetermined Energy Affected: No RIN Information URL: www.epa.gov/npdes Sectors Affected: 22132 Agency Contact: Kevin Weiss Environmental Protection Agency Water 4203M Washington , DC 20460 Phone: 202 564-0742FAX: 202 564-6392 E-Mail: weiss.kevin@epa.gov Agency Contact: Mohammed Billah Environmental Protection Agency Water 4203M Washington , DC 20460 Phone: 202 564-0729 FAX: 202 564-0717 E-Mail: Billah.Mohammed@epamail.epa.gov

Environmental Protection Agency (EPA) Water ( WATER ) RIN: 2040-AE95

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Title: Criteria and Standards for Cooling Water Intake Structures Abstract: Section 316(b) of the Clean Water Act (CWA) requires EPA to ensure that the location, design, construction, and capacity of cooling water intake structures reflect the best technology available (BTA) for minimizing adverse environmental impacts. In developing regulations to implement section 316(b), EPA divided its effort into three rulemaking phases. Phase II, for existing electric generating plants that use at least 50 MGD of cooling water, was completed in July 2004. Industry and environmental stakeholders challenged the Phase II regulations. On review, the U.S. Court of Appeals for the Second Circuit remanded several key provisions. In July 2007, EPA suspended Phase II. Following the decision in the Second Circuit, several parties petitioned the U.S. Supreme Court to review that decision, and the Supreme Court granted the petitions, limited to the issue of whether the Clean Water Act authorized EPA to consider the relationship of costs and benefits in establishing section316(b) standards. On April 1, 2009, the Supreme Court reversed the Second Circuit, finding that the Agency may consider costbenefit analysis in its decisionmaking but not holding that the Agency must consider costs and benefits in these decisions. In June 2006, EPA promulgated the Phase III regulation, covering existing electric generating plants using less than 50 MGD of cooling water, new offshore oil and gas facilities, and all existing manufacturing facilities. Petitions to review this rule were filed in the U.S. Court of Appeals for the Fifth Circuit. EPA has asked for, and was granted a partial voluntary remand of the determinations in the Phase III regulation concerning existing facilities, in order to issue a regulation that addresses both Phase II and III existing facilities. EPA expects this new rulemaking would apply to the approximately 1,200 existing electric generating and manufacturing plants.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: Undetermined CFR Citation: 40 CFR 9; 40 CFR 122; 40 CFR 123; 40 CFR 124; 40 CFR 125 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: CWA 101; CWA 308; CWA 316; CWA 402; CWA 501; CWA 510 Legal Deadline: None

Regulatory Plan: Statement of Need: In the absence of national regulations, NPDES permit writers have developed requirements to implement section 316(b) on a case-by-case basis. This may result in a range of different requirements, and, in some cases, delays in permit issuance or reissuance. This regulation may have substantial ecological benefits.

Legal Basis: The Clean Water Act requires EPA to establish best technology available standards to minimize adverse environmental impacts from cooling water intake structures. On February 16, 2004, EPA took final action on regulations governing cooling water intake structures at certain existing power producing facilities under section 316(b) of the Clean Water Act (Phase II rule). 69 FR 41576 (Jul. 9, 2004). These regulations were challenged , and the Second Circuit remanded several provisions of the Phase II rule on various grounds. Riverkeeper, Inc. v. EPA, 475F.3d83, (2d Cir., 2007). EPA suspended most of the rule in response to the remand. 72 FR 37107 (Jul. 9, 2007). The remand of Phase III does not change permitting requirements for these facilities. Until the new rule is issued, permit directors continue to issue permits on a case-by-case, Best Professional Judgment basis for Phase II facilities.

Alternatives: This analysis will cover various sizes and types of potentially regulated facilities, and control technologies. EPA is considering whether to regulate on a national basis, by subcategory, by broad water body category, or some other basis.

Costs and Benefits: The technologies under consideration in this rulemaking are similar to the technologies considered for the original Phase II and Phase III rules. Those costs evaluated for the Phase II remanded rule, in 2002 dollars, ranged from $389 million (the final rule option) to $440 million (the final rule option at proposal) to $1 billion to $3.5 billion (closed cycle cooling for facilities on certain waterbodies, or at all facilities). The monetized benefits of the original final rule were estimated to be $82 million. The monetized benefits include only the use value associated with quantifiable increases in commercial andrecreational fisheries. Non-use benefits were not analyzed. The costs and benefits of the Phase III option most closely aligned with the Phase II option co-promulgated were $38.3 million and $2.3 million respectively, in 2004 dollars. EPA will develop new costs and benefits estimates for this new effort.

Risks: Cooling water intake structures may pose significant risks for aquatic ecosystems.
Timetable:
Action Date FR Cite
NPRM 02/00/2011
Final Action 07/00/2012

Additional Information: EPA Docket information: EPA-HQ-OW-2008-0667

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; Local; State

Small Entities Affected: No Federalism: Undetermined Energy Affected: Undetermined RIN Information URL: www.epa.gov/waterscience/316b Agency Contact: Paul Shriner Environmental Protection Agency Water 4303T Washington , DC 20460 Phone: 202 566-1076 E-Mail: Shriner.Paul@epamail.epa.gov Agency Contact: Erik Helm Environmental Protection Agency Water 4303T Washington , DC 20460 Phone: 202 566-1049 E-Mail: helm.erik@epamail.epa.gov

Environmental Protection Agency (EPA) Water ( WATER ) RIN: 2040-AF13

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Title: Stormwater Regulations Revision To Address Discharges From Developed Sites Abstract: Stormwater discharge from developed areas is a major cause of degradation of surface waters. This is true for both conveyance of pollutants and the erosive power of increased stormwater flow rates and volumes. Current stormwater regulations were promulgated in 1990 and 1999. In 2006, the Office of Water asked the National Research Council (NRC) to review the stormwater program and recommend ways to strengthen it. The NRC Report, which was finalized in October 2008, found that the current stormwater program "...is not likely to adequately control stormwater's contribution to waterbody impairment" and recommended that EPA take action to address the harmful effects of stormwater flow. This proposed action would establish requirements for, at minimum, managing stormwater discharges from newly developed and re-developed sites, to reduce the amount of pollutants in stormwater discharges entering receiving waters by reducing the discharge of excess stormwater. This action may also expand the scope of municipal separate storm sewer systems (MS4) required to be regulated under NPDES permits, to include rapidly developing areas and to cover some discharges that are not currently regulated. The Phase I and Phase II MS4 regulations might also be combined and amended, and may include provisions for retrofitting existing development. In order to comply with the Executive order issued by President Obama on Mat 12, 2010, that among other things, require EPA to identify ways to strengthen stormwater management practices within the Bay watershed in order to restore and protect the Bay and its tributaries. EPA plans to include in this proposed rulemaking a separate section containing additional stormwater provisions for the Chesapeake Bay Watershed.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 33 USC 1251 et seq Legal Deadline:
Action Source Description Date

NPRM Judicial Chesapeake Bay Settlement Agreement; May 11, 2010; Fowler v US EPA, No 1 :09-CV -00005-CKK (D DC) 09/30/2011

Other Judicial Chesapeake Bay Settlement Agreement; May 11, 2010; Fowler v US 11/19/2012EPA, No 1 :09-CV -00005-CKK (D DC)

Regulatory Plan: Statement of Need: Section 402(p) of the Clean Water Act requires EPA to regulate certain stormwater discharges. Stormwater is a primary contributor of water quality impairment. There is a need to strengthen the stormwater program’s effectiveness by reducing pollutant loading from currently regulated and unregulated stormwater discharges and preserving surface water health and integrity. This action was informed by the 2006 National Research Council report.

Legal Basis: Section 402(p) of the Clean Water Act requires EPA to regulate certain discharges from stormwater in order to protect water quality.

Alternatives: To be determined.

Costs and Benefits: To be determined.

Risks: To be determined. Timetable:
Action Date FR Cite Notice—Public Meeting 00/00/0000
NPRM 09/00/2011
Final Action 12/00/2012

Additional Information: EPA Docket information: EPA-HQ-OW-2009-0817-0319

Regulatory Flexibility Analysis Required: Business; Governmental Jurisdictions Government Levels Affected: Federal; Local; State

Federalism: Undetermined Energy Affected: Undetermined RIN Information URL: www.epa.gov/npdes/stormwater/rulemaking Agency Contact: Connie Bosma Environmental Protection Agency Water 4203M Washington , DC 20460 Phone: 202 564-6773 FAX: 202 564-6392 E-Mail: Bosma.Connie@epamail.epa.gov Agency Contact: Janet Goodwin Environmental Protection Agency Water 4203M Washington , DC 20460 Phone: 202 566-1060 E-Mail: Goodwin.Janet@epamail.epa.gov

Environmental Protection Agency (EPA) Water ( WATER ) RIN: 2040-AF17

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Title: National Pollutant Discharge Elimination System (NPDES) Permit Regulations for New Dischargers and the Appropriate Use of Offsets With Regard to Water Quality Permitting Abstract: This rulemaking may consider how to best clarify EPA's approach to permitting new dischargers in order to ensure the protection of water quality under Clean Water Act section 301(b)(1)(C). The rulemaking may examine options to address the appropriate and permissible use of offsets, which ensures that NPDES permits are protective of water quality standards. The rulemaking may also examine options for addressing new dischargers in impaired waters, both when a TMDL is in place and prior to TMDL issuance.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: Undetermined CFR Citation: 40 CFR 122.4(i) (To search for a specific CFR, visit the Code of Federal Regulations )Legal Authority: 33 USC 1361; 33 USC 1311(b)(1)(C) Legal Deadline: None

Regulatory Plan: Statement of Need: The EPA is initiating a rulemaking to consider clarifying the EPA's interpretation of 40 CFR section 122.4(i) and addressing the adverse Ninth Circuit decision in Friends of Pinto Creek v. EPA (2007), which created uncertainty regarding the permitting of new dischargers. Through this rulemaking, EPA will consider how to best ensure that the requirements at 40 CFR 122.4(i) and/or related regulations pertaining to the permitting of new dischargers are consistent with Clean Water Act (CWA) requirements.

Legal Basis: Clean Water Act (CWA) section 301(b)(1)(C) requires permits to include limitation as stringent as necessary to meet water quality standards. The Federal regulations at 40 CFR 122.4(i) implements that requirement for new dischargers.

Alternatives: TBD

Costs and Benefits: TBD

Risks: TBD Timetable:
Action Date FR Cite
NPRM 04/00/2011
Final Action 01/00/2012

Additional Information: SAN No. 5240

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined

Small Entities Affected: No Federalism: Undetermined Energy Affected: No Agency Contact: Sara Hilbrich Environmental Protection Agency Water 4203M Washington , DC 20460 Phone: 202 564-0441 E-Mail: Hilbrich.Sara@epamail.epa.gov Agency Contact: Michelle Schutz Environmental Protection Agency Water 4203M Washington , DC 20460 Phone: 202 564-7374 E-Mail: Schutz.Michelle@epamail.epa.gov

Environmental Protection Agency (EPA) Water ( WATER ) RIN: 2040-AF22

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Title: Concentrated Animal Feeding Operations (CAFO) Information Collection Request Rule Abstract: Under the authority of section 308 of the CWA, EPA is proposing a rule to collect facility information from all Concentrated Animal Feeding Operations (CAFOs), which will provide a CAFO inventory and assist in implementing the 2008 CAFO rule.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Not Yet Determined Legal Deadline: None

Regulatory Plan: Statement of Need: Under the authority of section 308 of the CWA, EPA is proposing a rule to collect facility informationfrom all CAFOs, which will provide a CAFO inventory and assist in implementing the 2008 CAFO rule.

Legal Basis: EPA is proposing a rule to collect facility information from all CAFOs under the authority of section 308 of the CWA.

Alternatives:

Costs and Benefits:

Risks: Timetable:
Action Date FR Cite
NPRM 05/00/2011
Final Action 05/00/2012

Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Becky Mitschele Environmental Protection Agency Water 4203M Washington , DC 20460 Phone: 202 564-6418 E-Mail: Mitschele.Becky@epamail.epa.gov Agency Contact: George Utting Environmental Protection Agency Water 4203M Washington , DC 20460 Phone: 202 564-0744 E-Mail: utting.george@epa.gov

Environmental Protection Agency (EPA) Solid Waste and Emergency Response ( SWER ) RIN: 2050-AG60

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Title: Hazardous Waste Management Systems: Identification and Listing of Hazardous Waste: Carbon Dioxide (CO2) Injectate in Geological Sequestration Activities Abstract: On July 25, 2008, EPA published a proposed rule under the Safe Drinking Water Act Underground Injection Control Program to create a new class of injection wells (Class VI) for geological sequestration (GS) of carbon dioxide (CO2). 73 FR 43492. In response to that proposal, EPA received numerous comments asking for clarification on how the Resource Conservation and Recovery Act (RCRA) hazardous waste requirements apply to CO2 streams. EPA is now considering a proposed rule under RCRA to explore a number of options, including a conditional exemption from the RCRA requirements for hazardous CO2 streams in order to facilitate implementation of GS, while protecting human health and the environment.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: 40 CFR 261 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 6903; 42 USC 6912; 42 USC 6921-24 Legal Deadline: None

Regulatory Plan: Statement of Need: The Agency is taking this action in order to reduce the uncertainty associated with managing CO2 streams under RCRA subtitle C, which will enable the continued research and deployment of carbon capture storage activities.

Legal Basis: EPA expects the regulations to be proposed under the authority of sections 1004, 2002, 3001, 3002, 3003, and 3004 of RCRA, 42 U.S.C. 6903, 6912, 6921, 6922, 6923, and 6924.

Alternatives: EPA intends to analyze options for clarifying the applicability of RCRA subtitle C to CO2 streams being captured, transported, and sequestered in Class VI UIC wells, including a conditional exemption from the hazardous waste regulations.Costs and Benefits: The economic impact assessment for this action is presently under development, and there are no preliminary estimates of costs or benefits at this time.

Risks: EPA intends to evaluate how requirements under other statutes and programs (for example, Department of Transportation (DOT) regulations, and EPA's Underground Injection Control Class VI rule) may adequately address potentially unacceptable risks from the capture, transport, and geologic sequestration of CO2 streams. Therefore, EPA does not expect to perform a separate risk assessment of those CO2 streams.
Timetable:
Action Date FR Cite
NPRM 01/00/2011

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; State

Small Entities Affected: No Federalism: No Energy Affected: Undetermined Sectors Affected: 31-33; 48-49; 22 Agency Contact: Ross Elliott Environmental Protection Agency Solid Waste and Emergency Response 5304P Washington , DC 20460 Phone: 703 308-8748 FAX: 703 605-0594 E-Mail: Elliott.Ross@epa.gov Agency Contact: Mark Baldwin Environmental Protection Agency Solid Waste and Emergency Response 5304P Washington , DC 20460 Phone: 703 308-0157 E-Mail: Baldwin.Mark@epa.gov

Environmental Protection Agency (EPA) Solid Waste and Emergency Response ( SWER ) RIN: 2050-AG61

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Title: Financial Responsibility Requirements Under CERCLA Section 108(b) for Classes of Facilities in the Hard Rock Mining Industry Abstract: Section 108(b) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, establishes certain authorities concerning financial responsibility requirements. The Agency has identified classes of facilities within the Hard Rock mining industry as those for which financial responsibility requirements will be first developed. EPA intends to include requirements for financial responsibility, as well as notification and implementation.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: Undetermined CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 9601 et seq.; 42 USC 9608 (b) Legal Deadline: None

Regulatory Plan: Statement of Need: The Agency is currently examining various classes of facilities that may produce, transport, treat, store or dispose of hazardous substances for development of financial responsibility requirements under CERCLA section 108(b).

Legal Basis: Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended.

Alternatives: To be determined.

Costs and Benefits: To be determined.

Risks: To be determined.Timetable:
Action Date FR Cite Priority Notice 07/28/2009 74 FR 37213
NPRM 04/00/2011

Additional Information: EPA publication information: Priority Notice - http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809fc1ff; Split from RIN 2050-AG56.; EPA Docket information: EPA-HQ-SFUND-2009-0834

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined

Small Entities Affected: No Federalism: Undetermined Energy Affected: No Sectors Affected: 212 Agency Contact: Ben Lesser Environmental Protection Agency Solid Waste and Emergency Response 5302P Washington , DC 20460 Phone: 703 308-0314 E-Mail: Lesser.Ben@epa.gov Agency Contact: David Hockey Environmental Protection Agency Solid Waste and Emergency Response 5303P Washington , DC 20460 Phone: 703 308-8846 E-Mail: Hockey.David@epa.gov

Environmental Protection Agency (EPA) Solid Waste and Emergency Response ( SWER ) RIN: 2050-AG44

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Title: Identification of Non-Hazardous Secondary Materials That Are Solid Wastes Abstract: The Agency has proposed to define which non-hazardous secondary materials burned in combustion units are solid wastes under the Resource Conservation and Recovery Act (RCRA). This in turn will assist the Agency in determining which non-hazardous secondary materials will be subject to the emissions standards proposed under sections 112 and 129 of the Clean Air Act (CAA). If the secondary material is considered a "solid waste," the unit that burns the non-hazardous secondary material would be subject to the CAA section 129 requirements. The meaning of "solid waste" as defined under RCRA is important because CAA section 129, which regulates emissions from sources that combust solid wastes, states that the term "solid waste" shall have the meaning "established by the Administrator [pursuant to RCRA]."

Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 40 CFR 241 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 6903(27); 42 USC 6912(a)(1) Legal Deadline:
Action Source Description Date

NPRM Judicial 04/29/2010 Other Judicial 01/16/2011

Regulatory Plan: Statement of Need: EPA is preparing to establish new emission standards under CAA sections 112 and 129. In order to establish these new emission standards, EPA must determine at the federal level which non-hazardous secondary materials are considered "solid waste." The meaning of solid waste for purposes of these CAA standards is of particular importance since CAA section 129 states that the term "solid waste" shall have the meaning "established by the Administrator."

Legal Basis: EPA is promulgating this regulation under the authority of sections 2002(a)(1) and 1004(27) of RCRA, as amended, 42 U.S.C. 6912(a)(1) and 6903(27). Section 129(a)(1(D) of the CAA directs EPA to establish standards for Commercial and Industrial Solid Waste Incinerators (CISWI), which burn solid waste (CAA sec. 129(g)(6), 42 U.S.C. 7429). Section 129(g)(6) provides that the term, solid waste, is to be established by EPA under RCRA. Section 2002(a)(1) of RCRAauthorizes the Agency to promulgate regulations as are necessary to carry out the functions under the Act. The statutory definition of "solid waste" is provided in RCRA section 1004(27).

Alternatives: The Notice of Proposed Rulemaking (NPRM) proposes an "Alternative Approach" that is broader than the proposed solid waste definition. This alternative may be adopted in the final rule, if warranted by information presented during the public comment period or otherwise available in the rulemaking record. Under this alternative, most non-hazardous secondary materials that are burned in a combustion unit would be considered solid wastes. Only fuels or ingredients that are combusted and remain within the control of the generator and met the legitimacy criteria would not be solid wastes under thisalternative. This approach would not allow discarded materials processed into new product fuels to be considered as nonwastes, or allow for a petition process. This approach would expand the universe of non-hazardous secondary materials that would be considered to be solid wastes, and thus subject to CAA section 129. The proposed rule also takes comment on an approach that would classify all non-hazardous secondary materials that are burned in combustion units as solid wastes.

Costs and Benefits: The proposed rule specifies criteria under which non-hazardous secondary materials are considered solid wastes. Although the final rule will determine which section of the CAA under which a given combustion unit is regulated, this rule itself will not include any emission standards and will not require changes in the management or use of secondary materials. Only with the promulgation of the respective rules developed within EPA's Office of Air and Radiation (OAR) would society realize the costs, benefits, and other impacts. These impacts, therefore, are attributed entirely to the rules being developed by OAR.

Risks: Air emission risks will be reduced as a result of the current promulgation of three-related rules developed by OAR and this rule. However, material diversion risks may increase under certain limited scenarios. Timetable:
Action Date FR Cite
ANPRM 01/02/2009 74 FR 41 ANPRM Comment Period End 02/02/2009 NPRM Extension of Comment Period 06/09/2010 75 FR 32682
NPRM 06/04/2010 75 FR 31843 NPRM Comment Period End 07/19/2010 NPRM Comment Period Extended To 08/03/2010
Final Action 01/00/2011

Additional Information: EPA publication information: ANPRM - http://www.regulations.gov/search/Regs/home.html#documentDetail?R=090000648080b3d3; NPRM - http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480afbb78, NPRM - Extension of Comment Period - http://www.regulations.gov/search/Regs/home.html#documentDetail? For information on the proposed CAA emissions standards for boilers, process heaters, and commercial/industrial solid waste incinerators, see http://www.epa.gov/airquality/combustion/; EPA Docket information: EPA-HQ-RCRA-2008-0329

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; State; Tribal Small Entities Affected: No Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/epawaste/nonhaz/define/index.htm Agency Contact: Marc Thomas Environmental Protection Agency Solid Waste and Emergency Response 5303P Washington , DC 20460 Phone: 703 308-0023 FAX: 703 308-0509 E-Mail: Thomas.Marc@epa.gov Agency Contact: George Faison Environmental Protection Agency Solid Waste and Emergency Response 5303P Washington , DC 20460 Phone: 703 305-7652 FAX: 703 308-0509 E-Mail: Faison.George@epa.gov

Environmental Protection Agency (EPA)Air and Radiation ( AR ) RIN: 2060-AI43

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Title: Review of the National Ambient Air Quality Standards for Carbon Monoxide Abstract: Under the Clean Air Act, EPA is required to review and, if appropriate, revise the air quality criteria for the primary (health-based) and secondary (welfare-based) national ambient air quality standards (NAAQS) every 5 years. The last CO NAAQS review occurred in 1994 with a decision by the Administrator not to revise the existing standards. The current review which initiated in September 2007 includes the preparation of an Integrated Science Assessment, Risk/Exposure Assessment, and a Policy Assessment Document by EPA, with opportunities for review by EPA's Clean Air Scientific Advisory Committee and the public. These documents inform the Administrator's decision as to whether to retain or revise the standards.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: No CFR Citation: 40 CFR 50 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 7408; 42 USC 7409 Legal Deadline:
Action Source Description Date

NPRM Judicial US District Court Northern District of CA San Francisco Division 5/5/08 10/28/2010 Other Judicial US District Court Northern District of CA San Francisco Division 5/5/08 05/13/2011

Regulatory Plan: Statement of Need: As established in the Clean Air Act, the national ambient air quality standards for carbon monoxide are to be reviewed every 5 years.

Legal Basis: Section 109 of the Clean Air Act (42 U.S.C. 7409) directs the Administrator to propose and promulgate "primary" and "secondary" national ambient air quality standards for pollutants identified under section 108 (the "criteria" pollutants). The "primary" standards are established for the protection of public health, while "secondary" standards are to protect against public welfare.

Alternatives: The main alternatives for the Administrator's decision on the review of the national ambient air quality standards for CO are whether to retain or revise the existing standards.

Costs and Benefits: The Clean Air Act makes clear that the economic and technical feasibility of attaining standards are not to be considered in setting or revising the NAAQS, although such factors may be considered in the development of State plans to implement the standards. Accordingly, the Agency prepares cost and benefit information in order to provide States information that may be useful in considering different implementation strategies for meeting proposed or final standards. Cost and benefit information is not developed to support a NAAQS rulemaking until sufficient policy and scientific information is available to narrow potential options for the form and level associated with any potential revisions to the standard. Therefore, work on developing the plan for conducting the cost and benefit analysis will generally start 1 1/2 to 2 years following the start of a NAAQS review.

Risks: During the course of this review, risk assessments will be conducted to evaluate health risks associated with retention or revision of the CO standards.
Timetable:
Action Date FR Cite
NPRM 02/00/2011
Final Action 08/00/2011

Additional Information: EPA Docket information: EPA-HQ-OAR-2008-0015

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; State; Local; Tribal Small Entities Affected: No Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/ttn/naaqs/standards/co/s_co_index.html Agency Contact: Ines Pagan Environmental Protection Agency Air and Radiation C504-06 Research Triangle Park , NC 27711 Phone: 919 541-5469E-Mail: pagan.ines@epa.gov Agency Contact: Deirdre Murphy Environmental Protection Agency Air and Radiation C504-06 Research Triangle Park , NC 27711 Phone: 919 541-0729 E-Mail: murphy.deirdre@epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AO47

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Title: Review of the National Ambient Air Quality Standards for Particulate Matter Abstract: Under the Clean Air Act, EPA is required to review and, if appropriate, revise the air quality criteria for the primary (health-based) and secondary (welfare-based) national ambient air quality standards (NAAQS) every 5 years. On October 17, 2006, EPA published a final rule to revise the primary and secondary NAAQS for particulate matter to provide increased protection of public health and welfare. With regard to the primary standard for fine particles (generally referring to particles less than or equal to 2.5 micrometers in diameter, PM2.5), EPA revised the level of the 24-hour PM2.5 standard to 35 micrograms per cubic meter (ug/m3) and retained the level of the annual PM2.5 standard at 15 ug/m3. With regard to primary standards for particles generally less than or equal to 10 micrometers in diameter (PM10), EPA retained the 24-hour PM10 standard and revoked the annual PM10 standard. With regard to secondary PM standards, EPA made them identical in all respects to the primary PM standards, as revised. EPA initiated the current review in 2007 with a workshop to discuss key policy-relevant issues around which EPA would structure the review. This review includes the preparation of an Integrated Science Assessment (ISA), Risk/Exposure Assessment (REA), and a Policy Assessment (PA) by EPA, with opportunities for review by EPA's Clean Air Scientific Advisory Committee and the public. These documents inform the Administrator's decision as to whether to retain or revise the standards. The ISA was completed in December 2009, the final REAs for health risk assessment and visibility assessment were finalized in June and July 2010, respectively. The first draft PA was reviewed by CASAC on April 8-9, 2010. The second draft Policy Assessment was reviewed by CASAC on July 26-27, 2010.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: No CFR Citation: 40 CFR 50 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 7408; 42 USC 7409 Legal Deadline: None

Regulatory Plan: Statement of Need: As established in the Clean Air Act, the national ambient air quality standards for particulate matter are to be reviewed every 5 years.

Legal Basis: Section 109 of the Clean Air Act (42 U.S.C. 7409) directs the Administrator to propose and promulgate "primary" and "secondary" national ambient air quality standards for pollutants identified under section 108 (the "criteria" pollutants). The "primary" standards are established for the protection of public health, while "secondary" standards are to protect against public welfare.

Alternatives: The main alternatives for the Administrator's decision on the review of the national ambient air quality standards for particulate matter are whether to retain or revise the existing standards and, if revisions are necessary, the indicators, averaging times, forms and levels of the revised standards. Options for these alternatives will be developed as the rulemaking proceeds.

Costs and Benefits: The Clean Air Act makes clear that the economic and technical feasibility of attaining standards are not to be considered in setting or revising the NAAQS, although such factors may be considered in the development of State plans to implement the standards. Accordingly, the Agency prepares cost and benefit information in order to provide States information that may be useful in considering different implementation strategies for meeting proposed or final standards. Cost and benefit information is not developed to support a NAAQS rulemaking until sufficient policy and scientific information is available to narrow potential options for the form and level associated with any potential revisions to the standard. Therefore, work on developing the plan for conducting the cost and benefit analysis will generally start 1 1/2 to 2 years following the start of a NAAQS review.

Risks: During the course of this review, risk assessments have been conducted to evaluate health risks associated with retention or revision of the particulate matter standards.Timetable:
Action Date FR Cite
NPRM 03/00/2011
Final Action 11/00/2011

Additional Information: EPA Docket information: EPA-HQ-OAR-2007-0492

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; State; Tribal Small Entities Affected: No Federalism: No Energy Affected: No RIN Information URL: www.epa.gov/air/particlepollution/ Agency Contact: Beth Hassett-Sipple Environmental Protection Agency Air and Radiation C504-06 Research Triangle Park , NC 27711 Phone: 919 541-4605 FAX: 919 541-0237 E-Mail: hassett-sipple.beth@epa.gov Agency Contact: Karen Martin Environmental Protection Agency Air and Radiation C504-06 Research Triangle Park , NC 27711 Phone: 919 541-5274 FAX: 919 541-0237 E-Mail: Martin.Karen@epamail.epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AO72

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Title: Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of Sulfur Abstract: Under the Clean Air Act, EPA is required to review and, if appropriate, revise the air quality criteria for the primary (health-based) and secondary (welfare-based) national ambient air quality standards (NAAQS) every 5 years. On October 11, 1995, EPA published a final rule not to revise either the primary or secondary NAAQS for nitrogen dioxide (NO2). On May 22, 1996, EPA published a final decision that revisions of the primary and secondary NAAQS for sulfur dioxide (SO2) were not appropriate at that time, aside from several minor technical changes. On December 9, 2005, EPA's Office of Research and Development (ORD) initiated the current periodic review of NO2 air quality criteria with a call for information in the Federal Register (FR). On May 3, 2006, ORD initiated the current periodic review of SO2 air quality criteria with a call for information in the FR. Subsequently, the decision was made to review the oxides of nitrogen and the oxides of sulfur together, rather than individually, with respect to a secondary welfare standard for NO2 and SO2. This decision derives from the fact that NO2, SO2, and their associated transformation products are linked from an atmospheric chemistry perspective, as well as from an environmental effects perspective, most notably in the case of secondary aerosol formation and acidification in ecosystems. This review includes the preparation of an Integrated Science Assessment (ISA), Risk/Exposure Assessment (REA), and a Policy Assessment Document (PAD) by EPA, with opportunities for review by EPA's Clean Air Scientific Advisory Committee and the public. These documents inform the Administrator's proposed decision as to whether to retain or revise the standards. It should be noted that this review will be limited to only the secondary standards; the primary standards for SO2 and NO2 were reviewed separately. The ISA, REA and first draft PAD have been completed and a review of the second draft PAD by CASAC is anticipated on October 6 and 7, 2010.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: No CFR Citation: 40 CFR 50 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 7408; 42 USC 7409 Legal Deadline:
Action Source Description Date

NPRM Judicial The court has approved the amendments to the consent decree incorporating the revised dates. 07/12/2011

Other Judicial 03/20/2012Regulatory Plan: Statement of Need: As established in the Clean Air Act, the national ambient air quality standards for oxides of nitrogen and oxides of sulfur are to be reviewed every 5 years.

Legal Basis: Section 109 of the Clean Air Act (42 U.S.C. 7409) directs the Administrator to propose and promulgate "primary" and "secondary" national ambient air quality standards for pollutants identified under section 108 (the "criteria" pollutants). The "primary" standards are established for the protection of public health, while "secondary" standards are to protect against public welfare.

Alternatives: The main alternatives for the Administrator's decision on the review of the national ambient air quality standards for oxides of nitrogen and oxides of sulfur are whether to retain or revise the existing standards.

Costs and Benefits: The Clean Air Act makes clear that the economic and technical feasibility of attaining standards are not to be considered in setting or revising the NAAQS, although such factors may be considered in the development of State plans to implement the standards. Accordingly, the Agency prepares cost and benefit information in order to provide States information that may be useful in considering different implementation strategies for meeting proposed or final standards. Cost and benefit information is not developed to support a NAAQS rulemaking until sufficient policy and scientific information is available to narrow potential options for the form and level associated with any potential revisions to the standard. Therefore, work on the developing the plan for conducting the cost and benefit analysis will generally start 1 1/2 to 2 years following the start of a NAAQS review.

Risks: During the course of this review, risk assessments may be conducted to evaluate public welfare risks associated with retention or revision of the NOx/SOx secondary standards.
Timetable:
Action Date FR Cite
NPRM 07/00/2011
Final Action 03/00/2012

Additional Information: EPA Docket information: EPA-HQ-OAR-2007-1145

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; State; Tribal Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Bryan Hubbell Environmental Protection Agency Air and Radiation C504-02 Research Triangle Park , NC 27711 Phone: 919 541-0621 FAX: 919 541-0804 E-Mail: Hubbell.bryan@epa.gov Agency Contact: Ginger Tennant Environmental Protection Agency Air and Radiation C504-06 Research Triangle Park , NC 27711 Phone: 919 541-4072 FAX: 919 541-0237 E-Mail: Tennant.Ginger@epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AP52

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Title: National Emission Standards for Hazardous Air Pollutants for Coal- and Oil-Fired Electric Utility Steam Generating Units Abstract: On May 18, 2005 (70 FR 28606), EPA published a final rule requiring reductions in emissions of mercury from Electric Utility Steam Generating Units. That rule was vacated on February 8, 2008, by the U.S. Court of Appeals for the District of Columbia Circuit. As a result of that vacatur, coal- and oil-fired electric utility steam generating units remain on the list of sources that must be regulated under section 112 of the Clean Air Act (CAA). The Agency will develop standards under CAA section 112(d), which will reduce hazardous air pollutant (HAP) emissions from this source category. Recent court decisions on other CAA section 112(d) rules will be considered in developing this regulation.Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: Undetermined CFR Citation: 40 CFR 63 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Clean Air Act sec 112(d) Legal Deadline:
Action Source Description Date

NPRM Judicial No later than March 16, 2011, EPA shall sign for publication in the Federal Register a notice of proposed rulemaking. 03/16/2011

Other Judicial No later than November 16, 2011, EPA shall sign for publication in the Federal Register a notice of final rulemaking. 11/16/2011

Regulatory Plan: Statement of Need: Section 112(n)(1)(A) of the Clean Air Act required EPA to conduct a study of the hazards to public health resulting from emissions of hazardous air pollutants from electric utility steam generating units and, after considering the results of that study, determine whether it was appropriate and necessary to regulate such units under section 112. The study was completed in 1998 and in December 2000, EPA determined that it was appropriate and necessary to regulate coal- and oil-fired electric utility steam generating units and added such units to the list of sources for which standards must be developed under section 112. The February 8, 2008, vacatur of the May 18, 2005, Clean Air Mercury Rule and March 29, 2005, section 112(n) Revision Rule (which had removed such sources from the list) resulted in the requirement to regulate under section 112 being reinstated.

Legal Basis: Clean Air Act, section 112

Alternatives: Not yet determined.

Costs and Benefits: Not yet determined.

Risks: Not yet determined. Timetable:
Action Date FR Cite
NPRM 03/00/2011
Final Action 11/00/2011

Additional Information: EPA Docket information: EPA-HQ-OAR-2009-0234

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Federal; Local; State; Tribal Small Entities Affected: No Federalism: Undetermined Energy Affected: Undetermined Sectors Affected: 221112 Agency Contact: Bill Maxwell Environmental Protection Agency Air and Radiation D243-01 Research Triangle Park , NC 27711 Phone: 919 541-5430 FAX: 919 541-5450 E-Mail: maxwell.bill@epamail.epa.gov Agency Contact: Robert J Wayland Environmental Protection Agency Air and Radiation C439-01 Research Triangle Park , NC 27711 Phone: 919 541-1045 E-Mail: wayland.robertj@epamail.epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AP61

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Title: Control of Greenhouse Gas Emissions From Medium and Heavy-Duty VehiclesAbstract: This action will be jointly proposed by the Environmental Protection Agency (EPA) and the Department of Transportation (DOT) to set national emission standards under the Clean Air Act (CAA) and Energy Independence and Security Act (EISA) to reduce greenhouse gas emissions and improve fuel energy for heavy duty trucks and buses. This rulemaking would significantly reduce GHG emissions from future heavy duty vehicles by setting GHG standards that would lead to the introduction of GHG-reducing vehicle and engine technologies. This action follows the U.S. Supreme Court decision in Massachusetts vs. EPA and would follow EPA’s formal determination on endangerment for GHG emissions. This rulemaking also follows the Advance Notice of Proposed Rulemaking "Regulating Greenhouse Gas Emissions Under the Clean Air Act," (73 FR 44354, Jul. 20, 2008).

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: Private Sector CFR Citation: 40 CFR 1036, 1037, 1066, and 1068 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Clean Air Act sec 202 Legal Deadline: None

Regulatory Plan: Statement of Need: EPA recently proposed to find that emissions of greenhouse gases from new motor vehicles and engines cause or contribute to air pollution that may reasonably be anticipated to endanger public health and welfare. Therefore, there is a need to reduce GHG emissions from medium- and heavy-duty vehicles to protect public health and welfare. The medium- and heavy-duty truck sector accounts for approximately 18 percent of the U.S. mobile source GHG emissions and is the second largest mobile source sector. GHG emissions from this sector are forecast to continue increasing rapidly; reflecting the anticipated impact of factors such as economic growth and increased movement of freight by trucks. This rulemaking would significantly reduce GHG emissions from future medium- and heavy-duty vehicles by setting GHG standards that will lead to the introduction of GHG reducing vehicle and engine technologies.

Legal Basis: The Clean Air Act section 202(a)(1) states that "The Administrator shall by regulation prescribe (and from time to time revise) in accordance with the provisions of this section, standards applicable to the emission of any air pollutant from any class or classes of new motor vehicles or new motor vehicle engines, which in his judgment cause, or contribute to, air pollution which may reasonably be anticipated to endanger public health or welfare." Section 202(a) covers all on-highway vehicles including medium- and heavy-duty trucks. In April 2007, the Supreme Court found in Massachusetts v. EPA that greenhouse gases fit well within the Act’s capacious definition of “air pollutant” and that EPA has statutory authority to regulate emission of such gases from new motor vehicles. Lastly, in April 2009, EPA issued the Proposed Endangerment and Cause or Contribute Findings for Greenhouse Gases under the Clean Air Act. The endangerment proposal stated that greenhouse gases from new motor vehicles and engines cause or contribute to air pollution that may reasonably be anticipated to endanger public health and welfare.

Alternatives: The rulemaking proposal will include an evaluation of regulatory alternatives that can be considered in addition to the Agency's primary proposal. In addition, the proposal is expected to include tools such as averaging, banking, and trading of emissions credits as an alternative approach for compliance with the proposed program.

Costs and Benefits: Detailed analysis of economy-wide cost impacts, greenhouse gas emission reductions, and societal benefits will be performed during the rulemaking process. Initial estimates indicate that the vehicles produced during the first 5 years after implementation of the program could achieve reductions of up to 250 million metric ton of CO2 emissions during the lifetime of these trucks. The costs associated with the GHG control technologies are expected to pay for themselves through fuel cost savings within the first 2 to 5 years of the vehicle's life.

Risks: The failure to set new GHG standards for medium- and heavy-duty trucks risks continued increases in GHG emissions from the trucking industry and therefore increased risk of unacceptable climate change impacts. Timetable:
Action Date FR Cite
NPRM 12/00/2010
Final Action 08/00/2011

Additional Information: SAN No. 5355.

Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined Small Entities Affected: No Federalism: No Energy Affected: No Agency Contact: Byron Bunker Environmental Protection Agency Air and Radiation AAHDOC Ann Arbor , MI 48105 Phone: 734 214-4155E-Mail: Bunker.Byron@epamail.epa.gov Agency Contact: Angela Cullen Environmental Protection Agency Air and Radiation AAHDOC Ann Arbor , MI 48105 Phone: 734 214-4419 E-Mail: Cullen.Angela@epamail.epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AQ44

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Title: Review of the National Ambient Air Quality Standards for Lead Abstract: Under the Clean Air Act Amendments of 1977, EPA is required to review and if appropriate revise the air quality criteria for the primary (health-based) and secondary (welfare-based) national ambient air quality standards (NAAQS) every 5 years. On November 12, 2008, EPA published a final rule to revise the primary and secondary NAAQS for lead to provide increased protection for public health and welfare. With regard to the primary standard, EPA revised the level to 0.15 micrograms per cubic meter (ug/m3) of lead in total suspended particles and the averaging time to a rolling 3-month period with a maximum (not-to-be-exceeded) form, evaluated over a 3-year period. EPA revised the secondary standard to be identical in all respects to the revised primary standard. EPA has now initiated the next review. The review began in May 2010 with a workshop to discuss key policy-relevant issues around which EPA would structure the review. This review includes the preparation of an Integrated Science Assessment, and if warranted, a Risk/Exposure Assessment and also a Policy Assessment Document by EPA, with opportunities for review by EPA's Clean Air Scientific Advisory Committee and the public. These documents inform the Administrator's proposed decision as to whether to retain or revise the standards.

Priority: Economically Significant Agenda Stage of Rulemaking: Proposed Rule Major: Yes Unfunded Mandates: No CFR Citation: 40 CFR 50 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 7408; 42 USC 7409 Legal Deadline: None

Regulatory Plan: Statement of Need: As established in the Clean Air Act, the national ambient air quality standards for lead are to be reviewed every 5 years.

Legal Basis: Section 109 of the Clean Air Act (42 U.S.C. 7409) directs the Administrator to propose and promulgate "primary" and "secondary" national ambient air quality standards for pollutants identified under section 108 (the "criteria" pollutants). The "primary" standards are established for the protection of public health, while "secondary" standards are to protect against public welfare.

Alternatives: The main alternatives for the Administrator's decision on the review of the national ambient air quality standards for lead are whether to retain or revise the existing standards.

Costs and Benefits: The Clean Air Act makes clear that the economic and technical feasibility of attaining standards are not to be considered in setting or revising the NAAQS, although such factors may be considered in the development of State plans to implement the standards. Accordingly, the Agency prepares cost and benefit information in order to provide States information that may be useful in considering different implementation strategies for meeting proposed or final standards. Cost and benefit information is not developed to support a NAAQS rulemaking until sufficient policy and scientific information is available to narrow potential options for the form and level associated with any potential revisions to the standard. Therefore, work on developing the plan for conducting the cost and benefit analysis will generally start 1 1/2 to 2 years following the start of a NAAQS review.

Risks: During the course of this review, risk assessments may, as warranted, be conducted to evaluate health and/or environmental risks associated with retention or revision of the lead standards. Timetable:
Action Date FR Cite
NPRM 12/00/2013
Final Action 10/00/2014

Additional Information: EPA Docket information: EPA-HQ-OAR-2010-0108Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; State; Tribal Small Entities Affected: No Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/ttn/naaqs/standards/pb/s_pb_index.html Agency Contact: Deirdre Murphy Environmental Protection Agency Air and Radiation C504-06 Research Triangle Park , NC 27711 Phone: 919 541-0729 E-Mail: murphy.deirdre@epa.gov Agency Contact: Karen Martin Environmental Protection Agency Air and Radiation C504-06 Research Triangle Park , NC 27711 Phone: 919 541-5274 FAX: 919 541-0237 E-Mail: Martin.Karen@epamail.epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AM44

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Title: National Emission Standards for Hazardous Air Pollutants for Area Sources: Industrial, Commercial, and Institutional Boilers Abstract: The Clean Air Act (CAA) requires that EPA develop standards for toxic air pollutants, also known as hazardous air pollutants or air toxics for certain categories of sources. These pollutants are known or suspected to cause cancer and other serious health and environmental effects. This regulatory action will develop emission standards for boilers located at area sources. An area source facility emits or has the potential to emit less than 10 tons per year (tpy) of any single air toxic or less than 25 tpy of any combination of air toxics. Boilers burn coal and other substances such as oil or biomass (e.g., wood) to produce steam or hot water, which is then used for energy or heat. Industrial boilers are used in manufacturing, processing, mining, refining, or any other industry. Commercial and institutional boilers are used in commercial establishments, medical centers, educational facilities and municipal buildings. The majority of area source boilers covered by this proposed rule are located at commercial and institutional facilities and are generally owned or operated by small entities. EPA estimates that there are approximately 183,000 existing area source boilers at 91,000 facilities in the United States and that approximately 6,800 new area source boilers will be installed over the next 3 years. The rule will cover boilers located at area source facilities that burn coal, oil, biomass, or secondary "non-waste" materials. Natural gas-fired area source boilers are not part of the categories to be regulated. The rule will reduce emissions of a number of toxic air pollutants including mercury, metals, and organic air toxics. The standards for area sources must be technology-based. Standards for area sources can be based on either generally available control technology (GACT), or maximum achievable control technology (MACT). To determine GACT, we look at methods, practices and techniques that are commercially available and appropriate for use by the sources in the category. We consider the economic impacts on sources in the category and the technical capabilities of the firms to operate and maintain the emissions control systems. MACT can be based on the emissions reductions achievable through application of measures, processes, methods, systems, or techniques, but must at least meet minimum control levels as defined in the Clean Air Act. Economic impacts cannot be considered when determining those minimum control levels.

Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule
Major: Yes Unfunded Mandates: State, Local, Or Tribal Governments; Private Sector CFR Citation: 40 CFR 63 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Clean Air Act sec 112 Legal Deadline:
Action Source Description Date

NPRM Judicial 60-day extension granted on July 30, 2009. Additional 2-week extension was subsequently granted, and the signature date was April 29, 2010. 05/07/2010

Other Judicial 30-day extension granted from December 16, 2010. 01/16/2011

Regulatory Plan:Statement of Need: Section 112(c)(3) of the CAA requires EPA to develop rules to reduce specific air toxics emissions (30 urban toxic pollutants) that have been identified as posing the greatest threat to public health in the largest number of urban areas as a result of emissions from certain categories of area sources. Industrial boilers and institutional/commercial boilers are listed as two of the area source categories for regulation. In addition, both industrial boilers and commercial/institutional boilers are on the list of CAA 112(c)(6) source categories which requires that those categories be subject to MACT regulation for specific air toxics. These two categories were included on the list because of emissions of mercury and polycyclic organic matter (POM).

Legal Basis: Clean Air Act, section 112.

Alternatives: Not yet determined.

Costs and Benefits: EPA estimates the total nationwide capital cost for the rulemaking for existing and new boilers, as proposed, to be approximately $2.5 billion, with an annualized cost of 1 billion. The annual cost includes control device operation and maintenance and annual boiler tuneups, as well as monitoring, recordkeeping, reporting, and performance testing. EPA estimates that the proposal would reduce nationwide emissions from existing and new area source boilers by approximately 1,500 tons per year (tpy) of total air toxics, 1,500 pounds per year of mercury, 250 tpy of non-mercury metals, 9 tpy of POM, and 7,600 tpy of PM. These emissions reductions will lead to significant annual health benefits. In 2013, this rule will protect public health by avoiding: 110 to 300 premature deaths, 81 cases of chronic bronchitis, 190 nonfatal heart attacks, 169 hospital and emergency room visits, 190 cases of acute bronchitis, 16,000 days when people miss work, 2,100 cases of aggravated asthma, and 95,000 acute respiratory symptoms. The monetized benefits of this proposed regulatory action are estimated to range from $1 billion to $2.4 billion and $900 million to $2.2 billion, at 3 percent and 7 percent discount rates, respectively.

Risks: Not yet determined. Timetable:
Action Date FR Cite NPRM Extension of Comment Period 06/09/2010 75 FR 32682
NPRM 06/04/2010 75 FR 31895 NPRM Comment Period End 07/19/2010 NPRM Comment Period Extended To 08/03/2010
Final Action 01/00/2011

Additional Information: EPA publication information: NPRM - http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480afbb98; Related to RIN 2060-AQ25.; EPA Docket information: EPA-HQ-OAR-2006-0790

Regulatory Flexibility Analysis Required: Business; Governmental Jurisdictions; Organizations Government Levels Affected: Federal; Local; State; Tribal Federalism: Yes Energy Affected: No Sectors Affected: 611; 62; 44-45; 321 Related RINs: Related to 2060-AQ25 Agency Contact: Mary Johnson Environmental Protection Agency Air and Radiation D243-01 Research Triangle Park , NC 27711 Phone: 919 541-5025 E-Mail: johnson.mary@epa.gov Agency Contact: Robert J Wayland Environmental Protection Agency Air and Radiation C439-01 Research Triangle Park , NC 27711 Phone: 919 541-1045 E-Mail: wayland.robertj@epamail.epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AP50

View Related DocumentsTitle: Transport Rule (CAIR Replacement Rule) Abstract: On May 12, 2005, the Environmental Protection Agency (EPA) promulgated the Clean Air Interstate Rule, commonly known as CAIR (70 FR 25162). The CAIR used a cap and trade approach to reduce sulfur dioxide (SO2) and nitrogen oxides (NOx) emissions. On July 11, 2008, the D.C. Circuit issued an opinion finding parts of the CAIR unlawful and vacating the rule. On December 23, the D.C. Circuit issued a decision on the petitions for rehearing of the July 11 decision. The court granted EPA's petition for rehearing to the extent that it remanded the cases without vacatur of the CAIR. This ruling means that the CAIR remains in place temporarily but that EPA is obligated to promulgate another rule under Clean Air Act section 110(a)(2)(D) consistent with the court's July 11 opinion. This action would fulfill our obligation to develop a rule consistent with the July 11, 2008, and December 23, 2008, D.C. Court decisions.

Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Major: Yes Unfunded Mandates: Private Sector CFR Citation: 40 CFR 51, 52, 72, 78, 97 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 7401 et seq Legal Deadline: None

Regulatory Plan: Statement of Need: The Clean Air Transport Rule is necessary to help States address interstate transport of pollutants from upwind States to downwind nonattainment areas. Specifically, the rule is needed to respond to the remand of the Clean Air Interstate Rule by the U.S. Court of Appeals for the D.C. Circuit.

Legal Basis: The Clean Air Transport Rule is needed to help States address the requirements of section 110(a)(2)(D)(i) of the Clean Air Act. This section requires States to prohibit emissions that contribute significantly to downwind nonattainment with the national ambient air quality standards or which interfere with maintaining the standards in those downwind States.

Alternatives: To be determined.

Costs and Benefits: The proposed rule would yield more than $120 to $290 billion in annual benefits in 2014. This far outweighs the estimated annual costs of $2.8 billion for that year. Both the annual benefits and costs are in 2006 dollars. The emission reductions from this proposed rule would lead to significant annual health benefits. In 2014, this rule would protect public health by avoiding: 14,000 to 36,000 premature deaths, 21,000 cases of acute bronchitis, 23,000 nonfatal heart attacks, 26,000 hospital and emergency room visits, 1.9 million days when people miss work or school, 240,000 cases of aggravated asthma, and 440,000 upper and lower respiratory symptoms. Air quality improvements would lead to increased visibility in national and State parks, and increased protection for sensitive ecosystems including, Adirondack and Appalachian lakes, coastal waters and estuaries, and sugar maple forests.

Risks: To be determined. Timetable:
Action Date FR Cite
NPRM 08/02/2010 75 FR 45210 NODA 09/01/2010 75 FR 53613 NPRM Correcting Amendments 09/14/2010 75 FR 55711 NPRM Comment Period End 10/01/2010
Final Action 07/00/2011

Additional Information: EPA publication information: NPRM -http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480b25be1; EPA Docket information: EPA-HQOAR-2009-0491

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; State Small Entities Affected: Business; Governmental Jurisdictions Federalism: No
Energy Affected: Yes International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. RIN Information URL: www.epa.gov/airtransport Sectors Affected: 221112 Agency Contact: Gabrielle Stevens Environmental Protection Agency Air and Radiation 6204J Washington , DC 20460 Phone: 202 343-9252FAX: 202 343-2359 E-Mail: stevens.gabrielle@epamail.epa.gov Agency Contact: Meg Victor Environmental Protection Agency Air and Radiation 6204J Washington , DC 20460 Phone: 202 343-9193 E-Mail: Victor.Meg@epamail.epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AP77

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Title: Revision to Pb Ambient Air Monitoring Requirements Abstract: On November 12, 2008, the Environmental Protection Agency (EPA) revised the National Ambient Air Quality Standards (NAAQS) for lead (Pb) and associated monitoring requirements. The finalized monitoring requirements require State and local monitoring agencies to conduct Pb monitoring near Pb sources emitting 1.0 tons per year (tpy) or more and in large urban areas referred to as Core Based Statistical Areas (CBSA) with a population of 500,000 people or more. In January 2009, EPA received a petition from the Missouri Coalition for the Environment Foundation, Natural Resources Defense Council, the Coalition to End Childhood Poisoning, and Physicians for Social Responsibility requesting EPA reconsider the 1.0 tpy emission threshold. EPA granted the petition to reconsider on July 22, 2009. This action represents the results of the EPA’s reconsideration of the Pb monitoring requirements. A proposed revision was published on December 30, 2009, in which the EPA proposed to lower the emission threshold to 0.50 tpy, and to require Pb monitoring at the approximately 80 NCore sites instead of monitoring Pb in CBSA's with a population greater than 500,000. The EPA also requested comments on an emission threshold greater than 0.50 tpy, alternative approaches for monitoring Pb near airports, and on staggering the monitoring deployment over two years.

Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: No CFR Citation: 40 CFR 58 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 7403, 7410, 7601(a), 7611, and 7619 Legal Deadline: None

Regulatory Plan: Statement of Need: This action is in response to a petition to reconsider that the Agency received and granted on the Pb monitoring requirements contained in the revision to the Pb NAAQS (73 FR 66964).

Legal Basis: Clean Air Act title I

Alternatives: To be determined.

Costs and Benefits: To be determined.

Risks: To be determined. Timetable:
Action Date FR Cite
NPRM 12/30/2009 74 FR 69050 NPRM Comment Period End 02/16/2010
Final Action 01/00/2011

Additional Information: EPA publication information: NPRM -http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a74184; EPA Docket information: EPA-HQOAR-2006-0735

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; State Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/air/lead Sectors Affected: 9241Agency Contact: Kevin Cavender Environmental Protection Agency Air and Radiation C304-06 Research Triangle Park , NC 27711 Phone: 919 541-2364 FAX: 919 541-1903 E-Mail: Cavender.Kevin@epamail.epa.gov Agency Contact: Lewis Weinstock Environmental Protection Agency Air and Radiation C304-06 Research Triangle Park , NC 27711 Phone: 919 541-3661 FAX: 919 541-1903 E-Mail: Weinstock.Lewis@epamail.epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AP98

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Title: Reconsideration of the 2008 Ozone Primary and Secondary National Ambient Air Quality Standards Abstract: On March 12, 2008, EPA announced the final decision on the ozone national ambient air quality standards (NAAQS). Soon after that decision was signed on March 27, 2008 (73 FR 16436), the Clean Air Scientific Advisory Committee (CASAC) held an unsolicited public meeting and criticized EPA for setting primary and secondary standards that were not consistent with advice provided by the CASAC during review of the NAAQS. On July 25, 2008, several environmental and industry petitioners, as well as a number of States, sued EPA on the NAAQS decision, and the Court set a briefing schedule for the consolidated cases on December 23, 2008. On March 10, 2009, EPA requested that the Court vacate the briefing schedule and hold the consolidated cases in abeyance for 180 days. This request for extension was made to allow time for appropriate EPA officials appointed by the new Administration to determine whether the standards established in March 2008 should be maintained, modified, or otherwise reconsidered. Announcement of reconsideration of the March 2008 NAAQS decision occurred on September 16, 2009. The NAAQS proposal (including a proposal to stay implementation designations for the March 2008 NAAQS) was signed on January 6, 2010, with the final rule to be signed on or around October 2010. Reconsideration of the NAAQS will be limited to information and supporting documentation available to EPA and in the docket at the time of the March 2008 decision.

Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Major: Yes Unfunded Mandates: No CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 42 USC 7409 Legal Deadline: None

Regulatory Plan: Statement of Need: As established in the Clean Air Act, the national ambient air quality standards for ozone are to be reviewed every 5 years. As outlined in the abstract of this regulatory plan entry, this reconsideration is in response to actions by the courts regarding the last review in 2008.

Legal Basis: Section 109 of the Clean Air Act (42 U.S.C. 7409) directs the Administrator to propose and promulgate "primary" and "secondary" national ambient air quality standards for pollutants identified under section 108 (the "criteria" pollutants). The "primary" standards are established for the protection of public health, while "secondary" standards are to protect against public welfare.

Alternatives: The main alternatives for the Administrator's decision are whether to set different primary and secondary ozone standards than those set in 2008.

Costs and Benefits: A supplement to the RIA was prepared that presents the costs and benefits associated with the proposed revised ozone standards. This RIA was made available when the Notice of Proposed Rulemaking was published.

Risks: The current national ambient air quality standards for ozone are intended to protect against public health risks associated with morbidity and/or premature mortality and public welfare risks associated with adverse vegetation and ecosystem effects. During the course of this review, risk assessments will be conducted to evaluate health and welfare risks associated with retention or revision of the ozone standards.Timetable:
Action Date FR Cite
NPRM 01/19/2010 75 FR 2938 NPRM Comment Period End 03/22/2010
Final Action 12/00/2010

Additional Information: EPA publication information: NPRM - http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a7f618; Related to RIN 2060-AN24; EPA Docket information: EPA-HQ-OAR-2005-0172

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; Local; State; Tribal Small Entities Affected: No Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/air/criteria.html Related RINs: Related to 2060-AN24 Agency Contact: Susan Stone Environmental Protection Agency Air and Radiation C504-06 Research Triangle Park , NC 27711 Phone: 919 541-1146 FAX: 919 541-0237 E-Mail: stone.susan@epa.gov Agency Contact: Karen Martin Environmental Protection Agency Air and Radiation C504-06 Research Triangle Park , NC 27711 Phone: 919 541-5274 FAX: 919 541-0237 E-Mail: Martin.Karen@epamail.epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AQ09

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Title: Revisions to Motor Vehicle Fuel Economy Label Abstract: EPA is responsible for developing the fuel economy labels that are posted on window stickers of all new light duty cars and trucks sold in the U.S. and, beginning with the 2011 model year, on all new medium-duty passenger vehicles (a category that includes large sport-utility vehicles and passenger vans). In 2006, EPA updated how the city and highway fuel economy values are calculated, to better reflect typical real-world driving patterns and provide more realistic fuel economy estimates. Since then, increasing market penetration of advanced technology vehicles, in particular plug-in hybrid electric vehicles and electric vehicles, will require new metrics to effectively convey information to consumers. This action will amend the way in which fuel economy estimates are calculated and/or displayed. The changes in this action will not impact the Corporate Average Fuel Economy requirements.

Priority: Other Significant Agenda Stage of Rulemaking: Final Rule Major: No Unfunded Mandates: Undetermined CFR Citation: 40 CFR 85, 86, 600; 49 CFR 575 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Clean Air Act Legal Deadline: None

Regulatory Plan: Statement of Need: The Environmental Protection Agency (EPA) and the National Highway Traffic Safety Administration (NHTSA) have recently jointly proposed to redesign and add information to the current fuel economy label that is posted on the window sticker of all new cars and light-duty trucks sold in the U.S. The redesigned label will provide new information to American consumers about the fuel economy and consumption, fuel costs, and environmental impacts associated with purchasing new vehicles beginning with model year 2012 cars and trucks. This action will also develop new labels for certain advanced technology vehicles, which are poised to enter the U.S. market, in particular plug-in hybrid electric vehicles and electric vehicles. NHTSA and EPA are proposing these changes because the Energy Independence and Security Act (EISA) of2007 imposes several new labeling requirements, because the labels for conventional vehicles can be improved to help consumers make more informed vehicle purchase decisions, and because the time is right to develop new labels for advanced technology vehicles that are being commercialized.

Legal Basis: Both EPA and NHTSA have authority over labeling requirements related to fuel economy and environmental information under the Energy Policy and Conservation Act (EPCA) and the Energy Independence and Security Act (EISA), respectively. In order to implement that authority in the most coordinated and efficient way, the agencies have jointly proposed to revise the Fuel Economy label.

Alternatives: The rulemaking proposal includes an alternative label that is being considered in addition to the Agency’s primary proposal.

Costs and Benefits: The primary costs associated with this proposed rule come from revisions to the fuel economy label and codifying testing requirements for EVs and PHEVs. This rule is not economically significant under E.O. 12866 or any DOT or EPA policies and procedures because it does not exceed $100 million or meet other related standards. The primary benefits associated with this proposed rule come from any improvements in consumer decisionmaking that may lead to reduced vehicle and fuel costs for them. There may be additional effects on criteria pollutants and greenhouse gas emissions. At this time, EPA and NHTSA do not believe it is feasible to fully develop a complete benefits analysis of the potential benefits.

Risks: The failure to finalize updated conventional vehicle fuel economy labels and to create new labels for EVs and PHEVs will result in labels that are unhelpful and potentially misleading for consumers as they seek to select more energy efficient and environmentally friendly vehicles that meet their needs. Timetable:
Action Date FR Cite Notice--Public Meeting 09/28/2010 75 FR 59673
NPRM 09/23/2010 75 FR 58078 NPRM Comment Period End 11/22/2010
Final Action 02/00/2011

Additional Information: EPA Docket information: EPA-HQ-OAR-2009-0865

Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: No Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/fueleconomy/regulations.htm Agency Contact: Lucie Audette Environmental Protection Agency Air and Radiation NVFEL Ann Arbor , MI 48105 Phone: 734 214-4850 E-Mail: Audette.Lucie@epamail.epa.gov Agency Contact: Chelsea May Environmental Protection Agency Air and Radiation NVFEL Ann Arbor , MI 48105 Phone: 734 214-4226 E-Mail: May.Chelsea@epamail.epa.gov

Environmental Protection Agency (EPA) Air and Radiation ( AR ) RIN: 2060-AQ25

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Title: National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial, and Institutional Boilers and Process Heaters Abstract: Section 112 of the Clean Air Act (CAA) outlines the statutory requirements for EPA's stationary source air toxics program. Section 112 mandates that EPA develop standards for hazardous air pollutants (HAP) for both major and area sources listed under section 112(c). This regulatory action will finalize emission standards for boilers and process heaters located at major sources. Section 112(d)(2) requires that emission standards for major sources be based on the maximum achievable control technology (MACT). Industrial boilers and institutional/commercial boilers are on the list of section 112(c)(6)source categories. In this rulemaking, EPA will finalize standards for these source categories.

Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule
Major: Yes Unfunded Mandates: State, Local, Or Tribal Governments; Private Sector CFR Citation: 40 CFR 63 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: Clean Air Act sec 112 Legal Deadline:
Action Source Description Date

NPRM Judicial 60-day extension granted on June 30, 2009. An additional 2 weeks was subsequently granted. Signature date: April 29, 2010. 04/29/2010

Other Judicial 30-day extension granted from December 16, 2011. 01/16/2011

Regulatory Plan: Statement of Need: As a result of the vacatur of the Industrial Boiler MACT, the Agency will develop another rulemaking under CAA section 112 which will reduce hazardous air pollutant (HAP) emissions from this source category. Recent court decisions on other CAA section 112 rules will be considered in developing this regulation.

Legal Basis: Clean Air Act, section 112.

Alternatives: Not yet determined.

Costs and Benefits: EPA estimates the total national capital cost for the final rule to be approximately $9.5 billion in the year 2013, with a total national annual cost of $2.9 billion in the year 2013. The annual cost, which considers fuel savings, includes control device operation and maintenance as well as monitoring, recordkeeping, reporting, and performance testing. EPA estimates that implementation of the rulemaking, as proposed, would reduce nationwide emissions from major source boilers and process heaters by: 15,000 pounds per year of mercury, 3,200 tpy of non-mercury metals, 37,000 tpy of HCl, 50,000 tpy of PM, 340,000 tpy of SO2, 722 grams per year of dioxin and 1,800 tpy of volatile organic compounds. These emissions reductions would lead to the following annual health benefits. In 2013, this rule will protect public health by avoiding 1,900 to 4,800 premature deaths, 1,300 cases of chronic bronchitis, 3,000 nonfatal heart attacks, 3,200 hospital and emergency room visits, 3,000 cases of acute bronchitis, 250,000 days when people miss work, 33,000 cases of aggravated asthma, and 1,500,000 acute respiratory symptoms. The monetized value of the benefits ranges from $17 billion to $41 billion in 2013-- outweighing the costs by at least $14 billion.

Risks: Not yet determined. Timetable:
Action Date FR Cite NPRM Extension of Comment Period 06/09/2010 75 FR 32682
NPRM 06/04/2010 75 FR 32006 NPRM Comment Period End 07/19/2010 NPRM Comment Period Extended To 08/03/2010
Final Action 06/00/2011

Additional Information: EPA publication information: NPRM - http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480afbb49; Split from RIN 2060-AM44. This rulemaking combines the area source rulemaking for boilers and the rulemaking for re-establishing the vacated NESHAP for boilers and process heaters.; EPA Docket information: EPA-HQ-OAR-2002-0058

Regulatory Flexibility Analysis Required: Business; Governmental Jurisdictions; Organizations Government Levels Affected: Federal; Local; State; Tribal Federalism: Yes Energy Affected: No Sectors Affected: 325; 611; 322; 221; 321 Related RINs: Related to 2060-AM44 Agency Contact: Brian Shrager Environmental Protection Agency Air and Radiation C439-01 Research Triangle Park , NC 27711 Phone: 919 541-7689 E-Mail: shrager.brian@epa.gov Agency Contact: Robert J Wayland Environmental Protection Agency Air and RadiationC439-01 Research Triangle Park , NC 27711 Phone: 919 541-1045 E-Mail: wayland.robertj@epamail.epa.gov

Environmental Protection Agency (EPA) Office of Prevention, Pesticides and Toxic Substances ( OPPTS ) RIN: 2070-AJ32

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Title: Regulations To Facilitate Compliance With the Federal Insecticide, Fungicide, and Rodenticide Act by Producers of Plant-Incorporated Protectants (PIPs) Abstract: Plant-Incorporated Protectants (PIPs) are pesticidal substances intended to be produced and used in living plants and the genetic material needed for their production. EPA regulates PIPs under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), including issuing experimental use permits and commercial registrations. In 2001, EPA published rules establishing much of the current regulatory structure for PIPs. This rulemaking effort is intended to address the issues that were not addressed in 2001, including defining the nature of regulated production of PIPs and associated issues such as reporting, product labeling and record keeping. The rule will affect those persons who produce PIPs and is expected to clarify the legal requirements of their products at various production phases, improving their ability to conduct business. It is expected to also improve the ability of the EPA to identify and respond to instances where there are potentially significant violations. EPA also intends to address activities that the Agency does not believe warrant regulation and will consider exempting those activities, as appropriate, from FIFRA in whole or in part.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 40 CFR 174; 40 CFR 152; 40 CFR 156; 40 CFR 167; 40 CFR 168; 40 CFR 169; 40 CFR 172 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 7 USC 136a et seq Legal Deadline: None

Regulatory Plan: Statement of Need: This action is needed to clarify PIP regulations for the Agency and PIP developers, producers and farmers. Section 7 of FIFRA requires producers of pesticides to register their establishments with EPA and to submit annual reports stating the amounts of pesticides produced at each establishment. However, neither the Act nor the regulations promulgated under section 7 specifically address what constitutes the production of PIPs, or what units are relevant forpurposes of reporting amounts of PIPs produced. This has led to inconsistency and confusion in the registration of PIPproducing establishments and in the reporting of units of PIPs produced. Members of the PIP production industry have indicated that they are uncertain of their legal obligations for PIPs under FIFRA section 7 and have requested guidance on these matters. The Agency reviewed the concerns raised by industry and other stakeholders and reached the conclusion that, because of problems inherent in the application of the current regulations to this class of pesticides known as PIPs, EPA is unable to provide guidance. As written, the current regulations have been difficult to enforce with respect to PIPs. Ambiguity regarding the applicability of section 7 requirements makes it difficult for EPA and regulators in States and tribes to monitor production and subsequent distribution, sale and use of products, and can cause difficulties with respect to compliance inspection and enforcement. State and tribal involvement in compliance oversight can be greatly complicated by a lack of clear compliance requirements. This uncertainty may be resolved by a substantive modification of the regulations through rulemaking.

Legal Basis: EPA has regulatory authority to promulgate regulations under FIFRA sections 3(a), 8(a), 25(a), and 25(b) (7 U.S.C. 136a(a), 136f(a), 136w(a), and 136w(b)). PIPs are pesticides under FIFRA section 2 because they are introduced into plants with the intention of "preventing, destroying, repelling, or mitigating any pest...." (7 U.S.C. 136(u)). Under FIFRA section 2, any person who manufactures, prepares, compounds, propagates or processes any pesticide is a "producer." (7 U.S.C. 136(w)). FIFRA section 7 requires that producers of pesticides register the establishments where production occurs and requires that producers report their annual production (7 U. S. C. 136e). In addition, FIFRA section 8 provides that EPA may issue regulations requiring producers to maintain records with respect to their operations and to make such records available for inspection (7 U. S. C. 136f). Under FIFRA section 9, appropriately credentialed inspectors have the authority to conduct inspections at pesticide producing establishments, or other places where pesticides are being held for distribution or sale, for the purpose of inspecting products, labels and records, and for obtaining samples (7 U. S. C. 136g). FIFRA section 3(a) states that "[t]o the extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation limit the distribution, sale, or use in any State of any pesticide that is not registered under this Act and that is not the subject of an experimental use permit under section 5 or an emergency exemption under section 18." FIFRA section 8(a) states that "[t]he Administrator may prescribe regulations requiring producers, registrants, and applicants for registration to maintain such records with respect to their operations and the pesticides and device produced as the Administrator determines are necessary for the effective enforcement of this Act and to make the records available for inspection and copying in the same manner as providedin [FIFRA section 8(b)] ." FIFRA section 25(a) states that "[t]he Administrator is authorized in accordance with the procedure described in [sec. 25(a)(2) of the Act], to prescribe regulations to carry out the provisions of this Act. Such regulations shall take into account the difference in concept and usage between various classes of pesticides, including public health pesticides, and differences in environmental risk and the appropriate data for evaluating such risk between agricultural, nonagricultural, and public health pesticides." FIFRA section 25(b) states that "[t]he Administrator may exempt from the requirements of this Act by regulation any pesticide which the Administrator determines either (1) to be adequately regulated by another Federal agency, or (2) to be of a character which is unnecessary to be subject to this Act in order to carry out the purposes of this Act."

Alternatives: Alternatives will be presented in the preamble to the proposed rule.

Costs and Benefits: The Agency is conducting an economic analysis to inform decisions for the proposed rule. Anticipated benefits include greater certainty and transparency in terms of applicable requirements for these products. Since the proposed rulemaking is currently still under development, information about anticipated costs is not yet available.

Risks: This rulemaking is not intended to address a specific risk associated with registered PIPs. However, facilitating compliance with FIFRA requirements could minimize potential risks associated with inadvertent noncompliance. In addition the rulemaking is intended to provide a means to identify and minimize risks associated with use of unregistered PIPs for production for export. Timetable:
Action Date FR Cite
ANPRM 04/04/2007 72 FR 16312 Notice of Public Meeting 04/11/2007 72 FR 18191 ANPRM: Extension of Comment Period 05/23/2007 72 FR 28911 ANPRM Comment Period End 06/13/2007 ANPRM Comment Period Extended To 07/13/2007
NPRM 09/00/2011

Additional Information: EPA publication information: ANPRM -http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480220026; EPA Docket information: EPA-HQOPP-2006-1003

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal; State; Tribal Small Entities Affected: Business Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/pesticides/biopesticides/pips/index.htm Sectors Affected: 61131; 111; 32532; 54171 Agency Contact: Stephen Howie Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7201M Washington , DC 20460 Phone: 202 564-4146 FAX: 202 564-8502 E-Mail: Howie.Stephen@epa.gov Agency Contact: Elizabeth Milewski Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7201M Washington , DC 20460 Phone: 202 564-8480 FAX: 202 564-8502 E-Mail: Milewski.Elizabeth@epa.gov

Environmental Protection Agency (EPA) Office of Prevention, Pesticides and Toxic Substances ( OPPTS ) RIN: 2070-AJ46

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Title: Mercury; Regulation of Use in Certain Products Abstract: Mercury is well documented as a toxic, environmentally persistent substance that demonstrates the ability to bioaccumulate and to be atmospherically transported on a local, regional, and global scale. In addition, mercury can be environmentally transformed into methylmercury, which biomagnifies and is highly toxic. EPA has conducted a preliminaryanalysis via the Risk-Based Prioritization of Mercury in Certain Products. By compiling data pertaining to the stated costs, advantages, and disadvantages associated with mercury-free alternatives to certain mercury-containing products, EPA made a preliminary judgment that effective and economically feasible alternatives exist. These products include switches, relays/contactors, flame sensors, button cell batteries, and measuring devices (e.g., non-fever thermometers, manometers, barometers, pyrometers, flow meters, and psychrometers/hygrometers). Therefore, EPA is evaluating whether an action (or combination of actions) under Toxic Substances Control Act (TSCA) is appropriate for mercury used in such products. As appropriate, such an action(s) would involve a group(s) of these products. Specifically, EPA will determine whether the continued use of mercury in one or more of these products would pose an unreasonable risk to human health and the environment.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: Undetermined Unfunded Mandates: Undetermined CFR Citation: 40 CFR 750 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 15 USC 2605 Legal Deadline: None

Regulatory Plan: Statement of Need: Mercury is well documented as a toxic, environmentally persistent substance that demonstrates the ability to bioaccumulate and to be atmospherically transported on a local, regional, and global scale. In addition, mercury can be environmentally transformed into methylmercury, which biomagnifies and is highly toxic. Human health risks associated with elemental mercury and methylmercury are well documented. Humans can be exposed from products directly to elemental mercury vapor and indirectly through fish contaminated with methylmercury. EPA has conducted a preliminary analysis via the Risk-Based Prioritization of Mercury in Certain Products. By compiling data pertaining to the stated costs, advantages, and disadvantages associated with mercury-free alternatives to certain mercury-containing products, EPA made a preliminary judgment that effective and economically feasible alternatives exist. In its initial prioritization of mercury in certain products, EPA considered mercury's well documented toxicity, persistence, ability to bioaccumulate, ability to be environmentally transformed into methylmercury, and its demonstrated ability to be transported globally as well as locally and the availability of effective and economically feasible alternatives for mercury in certain products. EPA believes manufacturing, processing, use, or disposal of elemental mercury in these products may result in significant potential for human and environmental exposures to elemental mercury and methylmercury.

Legal Basis: EPA is evaluating whether an action (or combination of actions) under Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., is appropriate for mercury used in certain products. TSCA provides EPA with authority to require reporting, recordkeeping, and testing requirements, and restrictions relating to chemical substances and/or mixtures. Specifically, section 4 authorizes EPA to require testing of chemicals by manufacturers, importers, and processors where risks or exposures of concern are found. Section 5 authorizes EPA to require prior notice by manufacturers, importers, and processors when it identifies a "significant new use" that could result in exposures to, or releases of, a substance of concern. Section 6 gives EPA the authority to protect against unreasonable risk of injury to health or the environment from chemical substances. If EPA finds that there is a reasonable basis to conclude that the chemical's manufacture, processing, distribution, use or disposal presents an unreasonable risk, EPA may by rule take action to: prohibit or limit manufacture, processing, or distribution in commerce; prohibit or limit the manufacture, processing, or distribution in commerce of the chemical substance above a specified concentration; require adequate warnings and instructions with respect to use, distribution, or disposal; require manufacturers or processors to make and retain records; prohibit or regulate any manner of commercial use; prohibit or regulate any manner of disposal; and/or require manufacturers or processors to give notice of the unreasonable risk of injury, and to recall products if required. Section 8 authorizes EPA to require reporting and recordkeeping by persons who manufacture, import, process, and/or distribute chemical substances in commerce.

Alternatives: EPA has conducted a preliminary analysis via the Risk-Based Prioritization of Mercury in Certain Products. By compiling data pertaining to the stated costs, advantages, and disadvantages associated with mercury-free alternatives to certain mercury-containing products, EPA made a preliminary judgment that effective and economically feasible alternatives exist.

Costs and Benefits: As part of the economic, exposure, and risk assessment to support the current action, EPA is conducting a comprehensive use-substitute analysis and industry profile that will consider the costs and benefits of an action(or combination of actions) under Toxic Substances Control Act (TSCA). Those assessments consider the costs of mercurycontaining and mercury-free alternatives and the impact that any action would have on potentially affected stakeholders, including economic, human health, and environmental criteria.

Risks: As part of the economic, exposure, and risk assessment to support the current action, EPA is conducting a comprehensive use-substitute analysis and industry profile that will consider the risks associated with an action (or combination of actions) under Toxic Substances Control Act (TSCA). Those assessments consider the relative toxicity and other considerations associated with mercury-free alternatives to mercury-containing products and the impact that any action would have on potentially affected stakeholders, including economic, human health, and environmental criteria.Timetable:
Action Date FR Cite
NPRM 10/00/2011

Additional Information: SAN No. 5312

Regulatory Flexibility Analysis Required: Undetermined Government Levels Affected: Undetermined

Small Entities Affected: Business Federalism: Undetermined Energy Affected: No International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. RIN Information URL: http://www.epa.gov/mercury/ Agency Contact: Thomas Groeneveld Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7404T Washington , DC 20460 Phone: 202 566-1188 FAX: 202 566-0469 E-Mail: groeneveld.thomas@epa.gov Agency Contact: Lynn Vendinello Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7404T Washington , DC 20460 Phone: 202 566-0514 FAX: 202 566-0473 E-Mail: vendinello.lynn@epa.gov

Environmental Protection Agency (EPA) Office of Prevention, Pesticides and Toxic Substances ( OPPTS ) RIN: 2070-AJ54

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Title: Nanoscale Materials; Reporting Under TSCA Section 8(a) Abstract: Under section 8(a) of the Toxic Substances Control Act (TSCA), EPA is developing a proposal to establish reporting requirements for certain nanoscale materials. This rule would propose that persons who manufacture these nanoscale materials notify EPA of certain information including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The proposed reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 40 CFR 704 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 15 USC 2607(a) TSCA 8(a) Legal Deadline: None

Regulatory Plan: Statement of Need: EPA is proposing reporting requirements under section 8(a) of TSCA for persons who are manufacturing, importing, or processing existing nanoscale materials in commerce to collect data on these activities. The data will help EPA to take any measures to ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment.

Legal Basis: Section 8(a) of TSCA authorizes the Administrator to promulgate rules, which require each person (other than a small manufacturer, importer, or processor) who manufactures, imports, processes, or proposes to manufacture, import, or process a chemical substance, to maintain such records and submit such reports as the Administrator may reasonably require.

Alternatives: EPA developed a voluntary Nanoscale Materials Stewardship Program (NMSP) to complement and support its regulatory activities on nanoscale materials. EPA initiated the NMSP to quickly learn about commercially available nanoscale materials by soliciting existing data and information on a voluntary basis from manufacturers, importers, processors, and usersof nanoscale materials. In addition, the program was designed to identify and encourage use of risk management practices in developing and commercializing nanoscale materials. In its NMSP interim report, EPA identified data gaps for existing nanoscale material production, uses, and exposures, based on the information EPA received prior to January 2009. For example, EPA estimated that companies provided information on only about 10 percent of the nanomaterials that may be commercially available. EPA is proposing reporting requirements under section 8(a) of TSCA for persons who are manufacturing, importing, or processing nanoscale materials in commerce to address some of the data gaps identified in the NMSP interim report. EPA has not identified any other activities, including regulatory activities under TSCA that would address data gaps for existing nanoscale materials.

Costs and Benefits: EPA has evaluated the potential costs of 8(a) reporting requirements for potential manufacturers, importers, and processors that would be subject to the proposed rule. If an entity were to submit a notice to the Agency, the annual burden is estimated to average 157 hours per response. This information would facilitate EPA’s evaluation of the materials and consideration of appropriate action under TSCA to reduce any unreasonable risk to human health or the environment.

Risks: There is a growing body of scientific evidence showing the differences that exist between nanoscale material(s) and their non-nanoscale counterpart(s). Nanoscale materials may have different or enhanced properties--for example, electrical, chemical, magnetic, mechanical, thermal, or optical properties--or features, such as improved hardness or strength, that are highly desirable for applications in commercial, medical, military, and environmental sectors. These properties are a direct consequence of small size, which results in a larger surface area per unit of volume and/or quantum effects that occur at the nanometer scale (i.e., 1 x 10-9 meters). Small size itself can also be a desirable property of nanoscale materials that is exploited for miniaturization of applications/processes and/or stabilization or delivery of payloads to diverse environments or incorporation into diverse products. The properties that can make nanoscale materials desirable for commercial applications also raise questions whether the small size of nanoscale materials or the unique or enhanced properties of nanoscale materials may, under specific conditions, pose new or increased hazards to humans and the environment. Government, academic, and private sector scientists in multiple countries are performing research into the environmental and human health effects of diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence. These research findings point to the possibility for nanoscale materials to affect human health and the environment adversely. Research also indicates that not all materials in the nanoscale size range behave differently from larger sized materials of the same substance. Timetable:
Action Date FR Cite
NPRM 02/00/2011

Additional Information: EPA Docket information: EPA–HQ–OPPT–2010-0572

Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: Business Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/oppt/nano/ Sectors Affected: 325; 324 Agency Contact: Jim Alwood Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7405M Washington , DC 20460 Phone: 202 564-8974 E-Mail: Alwood.Jim@epa.gov Agency Contact: Jessica Barkas Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7405M Washington , DC 20460 Phone: 202 250-8880 E-Mail: Barkas.Jessica@epa.gov

Environmental Protection Agency (EPA) Office of Prevention, Pesticides and Toxic Substances ( OPPTS ) RIN: 2070-AJ67

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Title: Nanoscale Materials; Significant New Use Rule (SNUR) Abstract: EPA is developing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for nanoscale materials. This action would require persons who intend to manufacture, import, or process this/thesechemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent unreasonable risk to human health or the environment.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 40 CFR 721 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 15 USC 2604 Legal Deadline: None

Regulatory Plan: Statement of Need: EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of TSCA that would designate as a significant new use, any use of chemical substances as nanoscale materials after the proposed date of the rule. Persons who intend to manufacture, import, or process these chemical substances for the new use after the date of the proposed rule would be required to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent any unreasonable risks to human health or the environment.

Legal Basis: Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a "significant new use." EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)).

Alternatives: Nanoscale materials based on chemical substances already on the TSCA Inventory are considered existing chemical substances. These nanoscale materials do not require reporting as new chemical substances because they are nanoscale forms of chemical substances already in commerce. If EPA does not use authority under 5(a)(2) of TSCA to require notification of new uses of nanoscale materials, EPA would have to use existing chemical authority under sections 4, 6, and 8 of TSCA to gather data and address any unreasonable risks.

Costs and Benefits: EPA has evaluated the potential costs of reporting requirements for potential manufacturers, importers, and processors that would be subject to the significant new use rule. If an entity were to submit a notice to the Agency, the annual burden is estimated to average 95 hours per response. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs to prevent any unreasonable risks to human health or the environment.

Risks: There is a growing body of scientific evidence showing the differences that exist between nanoscale material(s) and their non-nanoscale counterpart(s). Nanoscale materials may have different or enhanced properties--for example, electrical, chemical, magnetic, mechanical, thermal, or optical properties--or features, such as improved hardness or strength, that are highly desirable for applications in commercial, medical, military, and environmental sectors. These properties are a direct consequence of small size, which results in a larger surface area per unit of volume and / or quantum effects that occur at the nanometer scale (i.e., 1 x 10-9 meters). Small size itself can also be a desirable property of nanoscale materials that is exploited for miniaturization of applications/processes and/or stabilization or delivery of payloads to diverse environments or incorporation into diverse products. The properties that can make nanoscale materials desirable for commercial applications also raise questions whether the small size of nanoscale materials or the unique or enhanced properties of nanoscale materials may, under specific conditions, pose new or increased hazards to humans and the environment. Government, academic, and private sector scientists in multiple countries are performing research into the environmental and human health effects of diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence. These research findings point to the possibility for nanoscale materials to affect human health and the environment adversely. Research also indicates that not all materials in the nanoscale size range behave differently from larger sized materials of the same substance. Timetable:
Action Date FR Cite
NPRM 02/00/2011

Additional Information: EPA Docket information: EPA–HQ–OPPT–2010-0572

Regulatory Flexibility Analysis Required: No Government Levels Affected: No Small Entities Affected: Business Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/oppt/nano/ Agency Contact: Jim Alwood Environmental Protection AgencyOffice of Prevention, Pesticides and Toxic Substances 7405M Washington , DC 20460 Phone: 202 564-8974 E-Mail: Alwood.Jim@epa.gov Agency Contact: Jessica Barkas Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7405M Washington , DC 20460 Phone: 202 250-8880 E-Mail: Barkas.Jessica@epa.gov

Environmental Protection Agency (EPA) Office of Prevention, Pesticides and Toxic Substances ( OPPTS ) RIN: 2070-AJ76

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Title: Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides Abstract: As part of a settlement agreement, EPA will propose revisions to the existing rule governing the protection of subjects in human research involving pesticides. The current rule, issued in 2006, provides protections for subjects in human research by (1) prohibiting research conducted or supported by EPA that would involve intentional exposure of human subjects who are children or pregnant or nursing women; (2) prohibiting EPA reliance in actions under the pesticide laws on research involving intentional exposure of children or pregnant or nursing women; (3) extending the substantive requirements of the Common Rule to the design and execution of research conducted by third-parties who intend to submit the data to EPA under the pesticide laws; and (4) establishing the Human Studies Review Board, an independent expert panel to review proposals for new research and reports of covered human research on which EPA proposes to rely under the pesticide laws. In settling this litigation, EPA agreed to propose to broaden the applicability of the 2006 rule to apply to research involving intentional exposure of a human subject to “a pesticide,” without limitation as to the regulatory statutes under which the data might be submitted, considered, or relied upon. The new proposed rule, therefore, would apply to all research with “pesticides,” as that term is defined in 7 U.S.C. 136(u) [Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), sec. 2(u)], submitted, considered, or relied upon under any regulatory statute that EPA administers. EPA also committed in the settlement agreement to propose amendments to the rule that would disallow consent by an authorized representative of a test subject and that would require the Agency, in its reviews of covered human research, to document its ethics and science considerations in terms of the recommendations articulated in the National Research Council’s 2004 report, Intentional Human Dosing Studies for EPA Regulatory Purposes.

Priority: Other Significant Agenda Stage of Rulemaking: Proposed Rule Major: No Unfunded Mandates: No CFR Citation: 40 CFR 26 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: PL 109-54, sec 201; 5 USC 301; 42 USC 300v-1(b); 7 USC 136 to 136y; 21 USC 346a Legal Deadline:
Action Source Description Date

NPRM Judicial Settlement Agreement Deadline for the Administrator's Signature 01/18/2011 Other Judicial Settlement Agreement Deadline for the Administrator's Signature 12/18/2011

Regulatory Plan: Statement of Need: In 2006, EPA promulgated a regulation governing the protection of subjects in human research involving pesticides. EPA settled litigation challenging the 2006 rule by promising to conduct this rulemaking.

Legal Basis: Public Law 109-54, section 201; 5 U.S.C. 301; 42 U.S.C. 300v-1(b); 7 U.S.C. 136 to 136y; 21 U.S.C. 346a

Alternatives: This action involves proposal of amendments to the 2006 rule consistent with a negotiated settlement, followed by receipt and response to public comments and promulgation of a final rule. Because alternative educational, voluntary, incentive-based, market-based, or other non-regulatory approaches could not resolve the legal challenge to the 2006 rule, they are not being considered. EPA retains discretion to adopt a final rule that differs from its proposal.

Costs and Benefits: Impacts are expected to be primarily procedural and limited to the costs of supporting the rulemaking effort itself. Expected benefits from this action will result from resolution of the litigation and establishing the stability of the rules governing regulated human research with pesticides by third parties.

Risks: Although no research is known of that would fall outside the scope of the 2006 rule but within the scope of theproposed amendment, this action addresses a perceived loophole for unethical human pesticide research to be submitted to EPA and relied on by the Agency under other regulatory statutes. Timetable:
Action Date FR Cite
NPRM 01/00/2011
Final Action 12/00/2011

Regulatory Flexibility Analysis Required: No Government Levels Affected: Federal Small Entities Affected: No Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/oppfead1/guidance/human-test.htm Agency Contact: John Carley Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7501P Washington , DC 20460 Phone: 703 305-7019 FAX: 703 308-4776 E-Mail: Carley.John@epa.gov Agency Contact: William Jordan Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7501P Washington , DC 20460 Phone: 703 305-1049 FAX: 703 308-4776 E-Mail: Jordan.William@epa.gov

Environmental Protection Agency (EPA) Office of Prevention, Pesticides and Toxic Substances ( OPPTS ) RIN: 2070-AJ57

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Title: Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, and Painting Program Abstract: On May 6, 2010, EPA proposed several revisions to the 2008 Lead Renovation, Repair, and Painting Program (RRP) rule that established accreditation, training, certification, and recordkeeping requirements, as well as work practice standards for persons performing renovations for compensation in most pre-1978 housing and child-occupied facilities. Current requirements include training renovators, other renovation workers, and dust sampling technicians; for certifying renovators, dust sampling technicians, and renovation firms; for accrediting providers of renovation and dust sampling technician training; for renovation work practices; and for recordkeeping. EPA is particularly concerned about dust lead hazards generated by renovations because of the well documented toxicity of lead, especially to younger children. This proposal includes additional requirements designed to ensure that lead-based paint hazards generated by renovation work are adequately cleaned after renovation work is finished and before the work areas are re-occupied. Specifically, EPA proposed to require dust wipe testing after many renovations covered by the RRP rule. For a subset of jobs involving demolition or removal of plaster through destructive means or the disturbance of paint using machines designed to remove paint through high-speed operation, such as power sanders or abrasive blasters, this proposal would also require the renovation firm to demonstrate, through dust wipe testing, that dust-lead levels remaining in the work area are below regulatory levels.

Priority: Economically Significant Agenda Stage of Rulemaking: Final Rule Major: Yes Unfunded Mandates: Private Sector CFR Citation: 40 CFR 745 (To search for a specific CFR, visit the Code of Federal Regulations ) Legal Authority: 15 USC 2601(c); 15 USC 2682(c)(3); 15 USC 2684; 15 USC 2686; 15 USC 2687 Legal Deadline:
Action Source Description Date

NPRM Judicial Signature 04/22/2010 Other Judicial Signature 07/15/2011

Regulatory Plan: Statement of Need: EPA is particularly concerned about dust lead hazards generated by renovations because children, especially younger children, are at risk for high exposures of lead-based paint dust via hand-to-mouth exposure. This rulemaking revision is being considered in response to a settlement agreement.Legal Basis: Section 402(c)(3) of the Toxic Substances Control Act (TSCA) requires EPA to regulate renovation or remodeling activities that create lead-based paint hazards in target housing, which is defined by statute to cover most pre-1978 housing, public buildings built before 1978, and commercial buildings. The work practice requirements for dust wipe testing and clearance, training, certification and accreditation requirements, and State, territorial, and tribal authorization provisions are being promulgated under the authority of TSCA sections 402(c)(3), 404, and 407 (15 U.S.C. 2682(c)(3), 2684, and 2687).

Alternatives: In addition to the proposed rule option, the Economic Analysis for the proposed rule analyzes several alternative options, including options with lower and higher thresholds (in terms of the amount of lead-based paint disturbed) for renovations that require dust wipe testing or clearance. See also the discussion in the preamble to the proposed rule at page 25058 et seq.

Costs and Benefits: Benefits. The proposed rule is estimated to generate benefits by providing greater assurance that dust-lead hazards created by renovations are adequately cleaned up, primarily by requiring renovation firms to provide building owners and occupants with information on dust lead levels remaining in the work area after many renovation projects, but also by requiring renovation firms to demonstrate that they have achieved regulatory clearance levels after some of the dustiest renovations. These changes will protect individuals residing in target housing or attending a child-occupied facility where these renovation events are performed. It will also protect individuals who move into target housing after such a renovation is performed, or who visit a friend, relative, or caregiver’s house where such a renovation is performed. EPA has estimated the number of individuals residing in target housing units or attending COFs where renovation events are performed. The proposed rule will benefit 809,000 children under the age of 6 and 7,547,000 individuals age 6 and older (including 96,000 pregnant women) per year by minimizing their exposure to lead dust generated by renovations. The low threshold option would protect 882,000 children under the age of 6 and 8,193,000 individuals age 6 and older, including 105,000 pregnant women. The high threshold option protects 706,000 children and 6,590,000 individuals age 6 and older, including 83,000 pregnant women. The remaining three alternative options (dust wipe testing only, clearance only, and third party dust wipe testing) would affect the same number of individuals as the proposed rule, although the amount of protection provided to some of those individuals may differ from the proposed rule. Costs. Total annualized costs for the proposed rule are $272 million per year using a 3 percent discount rate and $293 million per year using a 7 percent discount rate. Under the low threshold option, costs are $312 million per year with a 3 percent discount rate and $336 million per year with a 7 percent rate. Under the high threshold option, costs are $224 million per year with a 3 percent discount rate and $242 million per year with a 7 percent discount rate. The option that only requires dust wipe testing costs $268 million per year with a 3 percent discount rate and $288 million per year with a 7 percent discount rate. The option requiring clearance for all renovations covered by the proposed rule costs $367 million with a 3 percent discount rate and $394 million with a 7 percent discount rate. The option requiring the use of a third-party for dust wipe sampling costs $431 million per year with a 3 percent discount rate and $459 million per year with a 7 percent discount rate. These cost estimates are based on the assumption that improved lead test kits would be available.

Risks: Lead is known for its "broad array of deleterious effects on multiple organ systems via widely diverse mechanisms of action." (EPA Air Quality Criteria for Lead, October 2006). This array of health effects includes heme biosynthesis and related functions; neurological development and function; reproduction and physical development; kidney function; cardiovascular function; and immune function. There is also some evidence of lead carcinogenicity, primarily from animal studies, together with limited human evidence of suggestive associations. Of particular interest to EPA during the RRP rulemaking was the delineation of lowest observed effect levels for those lead-induced effects that are most clearly associated with blood lead levels of less than 10 micrograms per deciliter in children and adults. See also the discussion in the preamble to the proposed rule at page 25039 et seq. Timetable:
Action Date FR Cite
NPRM 05/06/2010 75 FR 25038 NPRM Comment Period End 07/06/2010 NPRM Extension of Comment Period 07/07/2010 75 FR 38959 NPRM Comment Period Extended To 08/06/2010
Final Action 07/00/2011

Additional Information: EPA publication information: NPRM -http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480ae7efa; EPA Docket information: EPA-HQOPPT-2005-0049

Regulatory Flexibility Analysis Required: Business Government Levels Affected: Federal; Local; State; Tribal Federalism: No Energy Affected: No RIN Information URL: http://www.epa.gov/lead/pubs/renovation.htm Agency Contact: Cindy Wheeler Environmental Protection AgencyOffice of Prevention, Pesticides and Toxic Substances 7404T Washington , DC 20460 Phone: 202 566-0484 E-Mail: Wheeler.Cindy@epa.gov Agency Contact: Michelle Price Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances 7404T Washington , DC 20460 Phone: 202 566-0744 E-Mail: Price.Michelle@epa.gov