ENVIRONMENTAL PROTECTION AGENCY (EPA) 

Statement of Priorities

Overview

 Created in the wake of elevated concern about environmental pollution, the U.S. Environmental 

Protection Agency opened its doors in downtown Washington, DC, on December 2, 1970. EPA was 

established to consolidate in one agency a variety of Federal research, monitoring, standard-setting, and 

enforcement activities to ensure environmental protection. EPA's mission is to protect human health and 

to safeguard the natural environment—air, water, and land—upon which life depends. For the past 40 

years, EPA has been working for a cleaner, healthier environment for the American people. 

 From regulating vehicle emissions to ensuring that drinking water is safe; from cleaning up toxic waste 

to assessing the safety of pesticides and chemicals; and from reducing greenhouse gas emissions to encouraging conservation, reuse, and recycling, EPA and its Federal, State, local, and community partners 

have made enormous progress in protecting the Nation’s health and environment. Our air and water have 

both grown significantly cleaner in the last 40 years. The number of Americans receiving water that 

meets health standards went from 79 percent in 1993, to 92 percent in 2008. We have also reduced 60 

percent of the dangerous air pollutants that cause smog, acid rain, lead poisoning, and more since the 

passage of the Clean Air Act in 1970. Innovations like smokestack scrubbers and catalytic converters in 

automobiles have helped this process. Today, new cars are 98 percent cleaner in terms of smog-forming 

pollutants than they were in 1970. Meanwhile, American families and businesses went from recycling 

about 10 percent of trash in 1980 to more than 33 percent in 2008. Eighty-three million tons of trash are 

recycled annually—the equivalent of cutting greenhouse gas emissions from more than 33 million 

automobiles. 

Highlights of EPA's Regulatory Plan

 Despite the Nation’s progress, however, much work remains. The environmental problems the country 

faces today are often more complex than those of years past, and implementing solutions—both 

nationally and globally—are more challenging. Addressing global climate change will call for coordinated 

efforts to research alternative fuels and other emission reduction technologies and will require strong 

partnerships across many economic sectors and around the world. Increased energy consumption and 

higher costs underscore the need to promote alternative energy sources and invest in new technologies. 

EPA and States face serious challenges in improving and maintaining the Nation’s drinking water and 

wastewater infrastructure, and both are seeking innovative ways to fund needed repairs and construction. 

EPA remains committed to working with global partners to advance shared priorities, not only by adapting 

to climate change, but also in ensuring national security, facilitating commerce, promoting sustainable 

development, protecting vulnerable populations, and engaging diplomatically around the world. 

Deepwater BP Oil Spill 

 EPA responded swiftly and transparently to the Deepwater BP oil spill in the Gulf of Mexico. The 

Agency has been working with local, State, and Federal response partners to provide sampling and realtime monitoring of the air, water, and sediment along the Gulf Coast. These efforts are intended to help 

States and other Federal agencies understand the immediate and long-term impacts of oil contamination 

and to ensure that residents in affected areas have access to information about the quality of their water. 

As part of its ongoing response, the Agency has developed new ways to provide the public with the latest 

data and information. EPA’s emergency response site (www.epa.gov/bpspill) has offered downloadable 

files with data on air, water, sediment, and waste conditions gathered since April 28th, just days after the 

spill. 

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 This spill has seriously affected the ecological and economic health of the Gulf Coast communities. 

Following the emergency response with a sustained, effective recovery and rebuilding effort will require 

significant commitments of resources, scientific and technical expertise, and coordination with a range of 

partners in the months and years ahead. 

Seven Guiding Priorities 

 The Deepwater BP oil spill and other challenges inspire the Agency and drive its commitment to 

excellent performance and strong, measurable results. EPA is committed to carrying out its mission while 

respecting its core values of science, transparency, and the rule of law. Effective, consistent enforcement 

is critical to achieving the human-health and environmental benefits expected from our environmental 

laws. To guide the Agency’s efforts in 2011 and subsequent years, Administrator Lisa P. Jackson has 

established seven guiding priorities. 

1. Taking Action on Climate Change 

 In 2009, EPA finalized an endangerment finding on greenhouse gases; issued the first national rules 

to reduce greenhouse gas emissions under the Clean Air Act; and initiated a national reporting system for 

greenhouse gas emissions. While EPA stands ready to help Congress craft strong, science-based 

climate legislation that addresses the spectrum of issues, the Agency will deploy existing regulatory tools 

as they are available and warranted. Using the Clean Air Act, EPA will finalize mobile source rules and 

provide a framework for continued improvements in that sector. In 2011, EPA will further develop the 

national reporting system for greenhouse gases to enable the agency to receive, 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 affects other parts of 

its core mission. 

 Greenhouse Gas Emissions Standards for Automobiles. Last year, EPA took the first Federal 

regulatory steps to address the problem of global climate change by requiring industries to report their 

greenhouse gas emissions, and by issuing regulations that reduce greenhouse emissions from cars and 

light trucks and increase the Nation's use of renewable fuels. Transportation sources emitted 28 percent 

of all U.S. greenhouse gas emissions in 2007 and have been the fastest-growing source of those 

emissions since 1990. This year EPA is taking another major step by proposing to set national emissions 

standards under section 202 of the Clean Air Act to control greenhouse gas emissions from heavy-duty 

trucks and buses. 

 Prevention of Significant Deterioration. In January 2011, EPA will begin implementing its Prevention of 

Significant Deterioration and title V Greenhouse Gas Tailoring rule. EPA issued a final rule in May 2010 

that establishes a common sense approach to addressing greenhouse gas emissions from stationary 

sources under the Clean Air Act (CAA) permitting programs. This final rule sets thresholds for greenhouse 

gas (GHG) emissions that define when permits under the New Source Review Prevention of Significant 

Deterioration (PSD) and title V Operating Permit programs are required for new and existing industrial 

facilities. The rule “tailors” the requirements of these CAA permitting programs to limit which facilities will 

be required to obtain PSD and title V permits. 

2. Improving Air Quality 

 Since passage of the Clean Air Act Amendments in 1990, nationwide air quality has improved 

significantly for the six criteria air pollutants for which there are national ambient air quality standards. 

Despite this progress, about 127 million Americans lived in counties with air considered unhealthy in 

2008. Long-term exposure to air pollution can cause cancer and damage to the immune, neurological, 

reproductive, cardiovascular, and respiratory systems. 

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 Review Air Quality Standards. Despite progress, millions of Americans still live in areas that exceed 

one or more of the national standards. Ground-level ozone and particle pollution still present challenges 

in many areas of the country. This year's regulatory plan describes efforts to review the primary National 

Ambient Air Quality Standards (NAAQS) for carbon monoxide, lead, and particulates. In addition, the 

Plan includes a joint review of the secondary NAAQS for oxides of nitrogen and oxides of sulfur. 

 Replacing the Clean Air Interstate Rule. In the spring of 2011, EPA expects to complete and begin 

implementing a rule to replace the Transport Rule that was remanded by the courts in 2008. 

Strengthening the standards and decreasing the emissions that contribute to interstate transport of air 

pollution will help many areas of the country attain the standards and achieve significant improvements in 

public health. 

 Cleaner Air from Improved Technology. EPA continues to address toxic air pollution under authority of 

the Clean Air Act Amendments of 1990. The centerpiece of this effort is the "Maximum Achievable 

Control Technology" (MACT) program, which requires that all major sources of a given type use emission 

controls that better reflect the current state of the art. This year's regulatory plan describes MACT 

standards under development for electric utility steam-generating units.

3. Assuring the Safety of Chemicals 

 One of EPA’s highest priorities is to make significant and long overdue progress in assuring the safety 

of chemicals. On September 29, 2009, Administrator Jackson announced clear principles to guide 

Congress in writing a new chemical risk management law that will fix the weaknesses in Toxic 

Substances Control Act (TSCA). EPA is shifting its focus to addressing high-concern chemicals and 

filling data gaps on widely produced chemicals in commerce. In 2011, EPA will aggressively assess and 

manage the risks of chemicals used in consumer products, and the workplace. 

 Management of Chemical Risks. EPA’s Administrator has highlighted the need to strengthen EPA’s 

chemical management program as one of her top priorities. Using sound science as a compass, the 

mission of the Office of Chemical Safety and Pollution Prevention (OCSPP) is to protect individuals, 

families, and the environment from potential risks of pesticides and other chemicals. In its implementation 

of these programs, OCSPP uses several different statutory authorities, including the Federal Insecticide, 

Fungicide, and Rodenticide Act, the Federal Food, Drug, and Cosmetic Act, the Toxic Substances Control 

Act (TSCA) and the Pollution Prevention Act, as well as collaborative and voluntary activities. 

 Enhancing EPA’s Current Chemicals Management Program under TSCA. As part of this 

comprehensive effort, EPA has developed plans on specific chemicals, which outline the concerns that 

each chemical may present and specific actions the Agency will take to address those concerns. The 

Agency considers a range of actions to address potential risks, including utilizing for the first time the 

TSCA section 5(b)(4) authority to list chemicals of concern. EPA also intends to propose several 

regulatory actions under TSCA to gather additional information on nanoscale chemical materials, which 

will help the Agency assess the safety of nanoscale chemicals. EPA is also taking a number of steps to 

provide the public with greater access to chemical information, which includes increased web access to 

TSCA data and new policies for the review of confidential business information (CBI) claims for 

substantial risk and health and safety studies. 

 Addressing Concerns with Legacy Chemicals – Lead and Mercury. EPA is continuing its efforts to 

combat childhood lead poisoning through implementation of the Lead Renovation, Repair, and Painting 

(RRP) rule, which includes consideration of a proposed rule to require that renovation firms perform dust 

wipe testing after certain renovations and provide the results of the testing to the owners and occupants 

of the building. EPA also is developing a number of actions to further reduce the use of mercury in a 

range of products, including switches, relays, and certain measuring devices. 

 Protecting Subjects in Human Research involving Pesticides. On June 18, 2010, EPA settled a 

lawsuit over its 2006 regulation that established protections for subjects of human research involving 

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pesticides. Under the settlement agreement, EPA agreed that by January 18, 2011, it will propose to 

broaden the applicability of the 2006 rule to apply to research involving intentional exposure of a human 

subject to “a pesticide,” without limitation as to the regulatory statutes under which the data might be 

submitted, considered, or relied upon. EPA also committed to propose amendments to the rule that 

would, if finalized, disallow consent by an authorized representative of a test subject and that would 

require the Agency, in its reviews of covered human research, to document its ethics and science 

considerations. 

 Defining the Nature of Regulated Production of Plant-Incorporated Protectants (PIPs). PIPs are 

pesticidal substances intended to be produced and used in living plants and the genetic material needed 

for their production. EPA regulates PIPs under FIFRA and FFDCA, including issuing experimental use 

permits and commercial registrations. However, these Acts and the current implementing regulations do 

not specifically address what constitutes the production of PIPs or what units are relevant for purposes of 

reporting amounts of PIPs produced. This has led to inconsistency and confusion in the registration of 

PIP-producing establishments and in the reporting of units of PIPs produced, which in turn has resulted in 

significant difficulties in terms of compliance and enforcement. EPA intends to propose regulations to 

clarify the legal requirements applicable to PIP products at various phases of production. This rule will 

benefit the public by ensuring that public health and the environment are adequately protected while 

reducing burden on the regulated community, thereby potentially reducing costs for consumers. 

4. Cleaning Up Its Communities 

 In 2009 EPA accelerated its Superfund program and confronted significant local environmental 

challenges like the asbestos Public Health Emergency in Libby, Montana and the coal ash spill in 

Kingston, Tennessee. Using all the tools at its disposal, including enforcement and compliance efforts, 

EPA will continue to focus on making safer, healthier communities in 2011. EPA meets this priority by 

focusing on preparation for, prevention and response to chemical and oil spills, accidents, and 

emergencies; enhancement of homeland security; increasing the beneficial use and recycling of 

secondary materials, the safe management of wastes and cleaning up contaminated property and making 

it available for reuse. EPA carries out these missions in partnership with other Federal agencies, states, 

tribes, local governments, communities, nongovernmental organizations, and the private sector. Several 

regulatory priorities for the upcoming fiscal year will promote stewardship and resource conservation and 

focus regulatory efforts on risk reduction and statutory compliance. 

 Financial Responsibility under Superfund. Section 108(b) of the Comprehensive Environmental 

Response, Compensation, and Liability Act (CERCLA), establishes certain authorities concerning 

financial responsibility requirements. The Agency has identified classes of facilities within the Hard Rock 

mining industry as those for which financial responsibility requirements will be first developed. This 

proposal will establish requirements for financial responsibility, notification, and implementation. 

 Non-Hazardous Secondary Materials. The Agency has proposed to define which non-hazardous 

secondary materials burned in combustion units are solid wastes under the Resource Conservation and 

Recovery Act (RCRA). This in turn will assist the Agency in determining which non-hazardous secondary 

materials will be subject to the emissions standards proposed under either section 112 or section 129 of 

the Clean Air Act (CAA). If the 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 new class of injection wells (Class VI) for geological sequestration (GS) of carbon 

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dioxide (CO2). EPA received numerous comments asking for clarification on how the Resource 

Conservation and Recovery Act (RCRA) hazardous waste requirements apply to CO2 streams. EPA is 

now considering a proposed rule under RCRA to explore a number of options. 

5. Protecting America’s Waters 

Despite considerable progress, America’s waters remain imperiled. Water quality and enforcement 

programs face complex challenges, from nutrient loadings and stormwater runoff to invasive species 

and drinking water contaminants. These challenges demand both traditional and innovative 

strategies. 

 Improving Water Quality. EPA plans to address challenging water quality issues in several 

rulemakings during fiscal year 2011. 

 Stormwater. First, EPA plans to propose a national rule to address stormwater discharges from new 

development and redevelopment and explore other regulatory improvements to its stormwater program. 

To address the degradation of water quality caused by stormwater discharges from impervious cover, 

EPA is exploring regulatory options, including establishing specific post construction requirements for 

stormwater discharges from, at a minimum, new development and redevelopment. Stormwater 

discharges from areas of impervious cover in developed areas are a significant contributor to water 

quality impairments in receiving waters. 

 Sanitary Sewer Overflows. EPA is also considering proposing modifications to the NPDES regulations 

as they apply to municipal sanitary sewer collection systems and sanitary sewer overflows (SSOs) in 

order to better protect the environment and public health from the harmful effects of sanitary sewer 

overflows and basement back ups. Some of the changes EPA is considering include establishing 

standard permit conditions for publicly owned treatment works (POTW) permits that specifically address 

sanitary sewer collection systems and SSOs, and clarifying the regulatory framework for applying NPDES 

permit conditions to municipal satellite collection systems. Municipal satellite collection systems are 

sanitary sewers owned or operated by a municipality that conveys wastewater to a POTW operated by a 

different municipality. 

 Use of Offsets. EPA plans to propose a National Pollutant Discharge Elimination System permit 

regulation for new dischargers and the appropriate use of offsets with regard to water quality permitting. 

This action may consider how to best clarify EPA's approach to permitting new dischargers in order to 

ensure the protection of water quality under Clean Water Act and may examine options to address the 

appropriate and permissible use of offsets which ensures that NPDES permits are protective of water 

quality standards. Additionally, EPA may examine options for addressing new dischargers in impaired 

waters, both when a TMDL is in place and prior to TMDL issuance. 

 Concentrated Animal Feeding Operations. In 2008, EPA amended the concentrated animal feeding 

operation (CAFO) regulation to require, among other things, CAFOs that discharge or propose to 

discharge to seek coverage under an NPDES permit. Under the authority of section 308 of the Clean 

Water Act, EPA is proposing a rule to collect facility information from all CAFOs which will provide a 

CAFO inventory and assist in implementing the 2008 CAFO rule. 

 Cooling Water Intake Structures. EPA plans to propose standards for cooling water intakes for electric 

power plants and for other manufacturers who use large amounts of cooling water. The goal of the 

proposed rule will be to protect aquatic organisms from being killed or injured through impingement or 

entrainment. 

 Improving Clean Water Act Enforcement. EPA has the primary responsibility to ensure that the Clean 

Water Act’s (CWA) National Pollutant Discharge Elimination System (NPDES) program is effectively and 

consistently implemented across the country, thus ensuring that public health and environmental 

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protection goals of the CWA are met. EPA needs site-specific information to provide national NPDES 

program direction and oversight, to inform Congress and the public, and to better ensure protection of 

public health and the environment. EPA plans to propose an NPDES Electronic Reporting Rule that will 

seek to improve the EPA’s access to facility-specific information for the diverse universe of NPDESregulated sources of wastewater discharges. Electronic reporting of NPDES information may be sought 

from NPDES permittees and/or States. 

6. Expanding the Conversation on Environmentalism and Working for Environmental Justice. 

 Environmentalism has been described as a conversation that we all must have because it is about 

protecting people in the places they live, work, and raise families. In FY 2011, the Agency is focused on 

expanding the conversation to include new stakeholders and involve communities in more direct ways. 

 In managing risk and in ensuring that environmental rules protect all Americans, EPA directs its efforts 

toward identifying and mitigating exposures and other factors in our communities, schools, homes, and 

workplaces that might negatively impact human health and environmental quality. A renewed focus is 

being placed on the continuing Environmental Justice (EJ) efforts to address the environmental and 

public health concerns of minority, low income, tribal, and other disproportionately burdened communities 

and focus on improving environmental and public health protection in these communities. 

 Environmental Justice in Rulemaking. In July 2010, EPA released an interim guidance document to 

help Agency staff include environmental justice principles in its rulemaking process. The rulemaking 

guidance is an important and positive step toward meeting EPA Administrator Lisa P. Jackson’s priority to 

work for environmental justice and protect the health and safety of communities who have been 

disproportionately impacted by pollution. In carrying out this mandate, EPA will also seek to ensure that 

such communities do not experience disproportionate economic impacts from its programs and 

regulations. 

 Children’s Health. The protection of vulnerable subpopulations is one of the EPA’s top priorities, 

especially with regard to children. EPA’s revitalized Children’s Health Office is bringing a new energy to 

safeguarding children through the entire Agency’s regulatory and enforcement efforts. In 2011, EPA will 

co-lead an interagency effort in integrating existing school programs including asthma, indoor air quality, 

chemical safety and management, green practices, and enhanced use of integrated pest management. 

7. Building Strong State and Tribal Partnerships 

 EPA's success depends more than ever on working with increasingly capable and environmentally 

conscious partners. The Agency works with the States and tribes, business and industry, nonprofit 

organizations, environmental groups, and educational institutions in a wide variety of collaborative efforts. 

Currently, more than 13,000 firms and other organizations participate in EPA partnership programs. 

States and tribal nations bear important responsibilities for the day-to-day mission of environmental 

protection, but declining tax revenues and fiscal challenges are pressuring State agencies and tribal 

governments to do more with fewer resources. EPA must do its part to support State and tribal capacity. 

 Recognizing the Right of Tribes as Sovereign Nations. In FY 2009, EPA Administrator Jackson reaffirmed the Agency’s Indian Policy, which recognizes that the United States has a unique legal relationship 

with tribal governments based on treaties, statutes, executive orders, and court decisions. EPA 

recognizes the right of Tribes as sovereign governments to self-determination and acknowledges the 

federal government’s trust responsibility to Tribes. In FY 2011, EPA and Tribes are focusing on drinking 

water, sanitation, schools, and properly managing solid and hazardous waste on tribal lands. 

Conclusion 

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 These priorities will guide EPA’s work in the years ahead. They are built around the challenges and 

opportunities inherent in our mission to protect human health and the environment for all Americans. This 

mission is carried out by respecting EPA’s core values of science, transparency, and the rule of law. 

Within these parameters, EPA carefully considers the impacts its regulatory actions will have on society. 

Aggregate Costs and Benefits 

 EPA has calculated a combined aggregate estimate of the costs and benefits of regulations included 

in the regulatory plan. For the fiscal year 2009, EPA has been able to gather sufficient data on 5 of the 30 

anticipated regulations to include them in an aggregate estimate. For the remaining actions, costs and 

benefits have not yet been calculated for various reasons. 

 The regulations included in the aggregate estimate of costs and benefits are: 

• Federal Transport Rule; 

• Combined Rulemaking for Industrial, Commercial, and Institutional Boilers and Process Heaters at 

Major Sources of HAP and Industrial, Commercial, and Institutional Boilers at Area Sources; 

• National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial & 

Institutional Boilers and Process Heaters; 

• Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, and Painting 

Program; and 

• Criteria and Standards for Cooling Water Intake Structures—Phase II Remand. 

 EPA obtained aggregate estimates of total costs and benefits assuming both a 3 percent discount rate 

and a 7 percent discount rate. One of the five regulations (TSCA Lead Renovation) included costs 

estimates but provided no estimate of the monetized benefit of the rule. Given a 3 percent discount rate, 

benefits range from $144 billion to $349 billion. With a 7 percent discount rate, benefits range from $132 

billion to $323 billion. Costs were relatively constant, approximately $6 billion, regardless of the discount 

rate. All values are 2008 dollars. For the two rules that did not use a 2008 base year, values were 

converted using a GDP deflator. 

 These results should be considered with caution for a number of reasons. First, there are significant 

gaps in data. In general, the benefits estimates reported above do not include values for benefits that 

have been quantified but not monetized and missing values for qualitative benefits, such as some human 

health benefits and ecosystem health improvements. Second, methodologies and types of costs/benefits 

considered are inconsistent, as are the units of analysis. Some of the costs/benefits are described as 

annualized values while other values are specific to one year. Third, problems with aggregation can arise 

from differing baselines. Finally, the ranges presented do not reflect the full range of uncertainty in the 

benefit and cost estimates for these rules. 

Rules Expected to Affect Small Entities 

 By better coordinating small business activities, EPA aims to improve its technical assistance and 

outreach efforts, minimize burdens to small businesses in its regulations, and simplify small businesses' 

participation in its voluntary programs. Actions that may affect small entities can be tracked on EPA’s 

Rulemaking Gateway (http://www.epa.gov/lawsregs/rulemaking/index.html) at any time. This Plan 

includes a number of rules that may be of particular interest to small entities: 

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

and Institutional Boilers (2060-AM44); 

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

and Institutional Boilers and Process Heaters (2060-AQ25); 

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• Lead; Clearance and Clearance Testing Requirements for the Renovation, Repair, and Painting 

Program (2070-AJ57) 

• Stormwater Regulations Revision to Address Discharges from Developed Sites (2040-AF13). 

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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

 View Related Documents

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 NPDES

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permittees 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), permitting

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

10
information (including permit applications), various program reports (e.g., pretreatment compliance reports from approved local

pretreatment programs, annual reports from concentrated animal feeding operations, biosolids reports, sewage overflow incident

reports, annual reports for pesticide applicators, annual reports for municipal storm water systems), and annual compliance

certifications. Some States might also raise the possibility of supplying only 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 20460 

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

11
Phone: 202 566-0742 

E-Mail: Dombrowski.John@epamail.epa.gov

Environmental Protection Agency (EPA) 

Water ( WATER ) RIN: 2040-AD02

 View Related Documents

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: 202 564-0742 

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

12
FAX: 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

 View Related Documents

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 section

316(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 and

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

13
recreational fisheries. Non-use benefits were not analyzed. The costs and benefits of the Phase III option most closely aligned

with the Phase II option co-promulgated were $38.3 million and $2.3 million respectively, in 2004 dollars. EPA will develop new

costs and benefits estimates for this new effort.

Risks: Cooling water intake structures may pose significant risks for aquatic ecosystems.

Timetable:

Action Date FR Cite

NPRM 02/00/2011 

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

 View Related Documents

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 11/19/2012 

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

14
EPA, 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

 View Related Documents

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 ) 

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

15
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

 View Related Documents

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 information

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

16
from 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

 View Related Documents

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.

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

17
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

 View Related Documents

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.

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

18
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

 View Related Documents

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 RCRA

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

19
authorizes the Agency to promulgate regulations as are necessary to carry out the functions under the Act. The statutory

definition of "solid waste" is provided in RCRA section 1004(27).

Alternatives: The Notice of Proposed Rulemaking (NPRM) proposes an "Alternative Approach" that is broader than the

proposed solid waste definition. This alternative may be adopted in the final rule, if warranted by information presented during

the public comment period or otherwise available in the rulemaking record. Under this alternative, most non-hazardous

secondary materials that are burned in a combustion unit would be considered solid wastes. Only fuels or ingredients that are

combusted and remain within the control of the generator and met the legitimacy criteria would not be solid wastes under this

alternative. This approach would not allow discarded materials processed into new product fuels to be considered as 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) 

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

20
Air and Radiation ( AR ) RIN: 2060-AI43

 View Related Documents

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: 919 541-5469 

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

21
E-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

 View Related Documents

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.

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

22
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

 View Related Documents

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 03/20/2012 

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

23
Regulatory 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

 View Related Documents

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.

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

24
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

 View Related Documents

Title: Control of Greenhouse Gas Emissions From Medium and Heavy-Duty Vehicles

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

25
Abstract: This action will be jointly proposed by the Environmental Protection Agency (EPA) and the Department of

Transportation (DOT) to set national emission standards under the Clean Air Act (CAA) and Energy Independence and Security

Act (EISA) to reduce greenhouse gas emissions and improve fuel energy for heavy duty trucks and buses. This rulemaking

would significantly reduce GHG emissions from future heavy duty vehicles by setting GHG standards that would lead to the

introduction of GHG-reducing vehicle and engine technologies. This action follows the U.S. Supreme Court decision in

Massachusetts vs. EPA and would follow EPA’s formal determination on endangerment for GHG emissions. This rulemaking

also follows the Advance Notice of Proposed Rulemaking "Regulating Greenhouse Gas Emissions Under the Clean Air Act," (73

FR 44354, Jul. 20, 2008).

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: 734 214-4155 

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

26
E-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

 View Related Documents

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-2010-0108

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

27
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/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

 View Related Documents

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:

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

28
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 Documents

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

29
Title: 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: 202 343-9252 

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

30
FAX: 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

 View Related Documents

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: 9241

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

31
Agency Contact: Kevin Cavender Environmental Protection Agency

Air and Radiation

C304-06

Research Triangle Park , NC 27711 

Phone: 919 541-2364 

FAX: 919 541-1903

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

 View Related Documents

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.

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

32
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

 View Related Documents

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) of

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

33
2007 imposes several new labeling requirements, because the labels for conventional vehicles can be improved to help

consumers make more informed vehicle purchase decisions, and because the time is right to develop new labels for advanced

technology vehicles that are being commercialized.

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

 View Related Documents

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)

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

34
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 Radiation

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

35
C439-01

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

 View Related Documents

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 for

purposes of reporting amounts of PIPs produced. This has led to inconsistency and confusion in the registration of PIPproducing establishments and in the reporting of units of PIPs produced. Members of the PIP production industry have

indicated that they are uncertain of their legal obligations for PIPs under FIFRA section 7 and have requested guidance on

these matters. The Agency reviewed the concerns raised by industry and other stakeholders and reached the conclusion that,

because of problems inherent in the application of the current regulations to this class of pesticides known as PIPs, EPA is

unable to provide guidance. As written, the current regulations have been difficult to enforce with respect to PIPs. Ambiguity

regarding the applicability of section 7 requirements makes it difficult for EPA and regulators in States and tribes to monitor

production and subsequent distribution, sale and use of products, and can cause difficulties with respect to compliance

inspection and enforcement. State and tribal involvement in compliance oversight can be greatly complicated by a lack of clear

compliance requirements. This uncertainty may be resolved by a substantive modification of the regulations through rulemaking.

Legal Basis: EPA has regulatory authority to promulgate regulations under FIFRA sections 3(a), 8(a), 25(a), and 25(b) (7

U.S.C. 136a(a), 136f(a), 136w(a), and 136w(b)). PIPs are pesticides under FIFRA section 2 because they are introduced into

plants with the intention of "preventing, destroying, repelling, or mitigating any pest...." (7 U.S.C. 136(u)). Under FIFRA section

2, any person who manufactures, prepares, compounds, propagates or processes any pesticide is a "producer." (7 U.S.C.

136(w)). FIFRA section 7 requires that producers of pesticides register the establishments where production occurs and requires

that producers report their annual production (7 U. S. C. 136e). In addition, FIFRA section 8 provides that EPA may issue

regulations requiring producers to maintain records with respect to their operations and to make such records available for

inspection (7 U. S. C. 136f). Under FIFRA section 9, appropriately credentialed inspectors have the authority to conduct

inspections at pesticide producing establishments, or other places where pesticides are being held for distribution or sale, for the

purpose of inspecting products, labels and records, and for obtaining samples (7 U. S. C. 136g). FIFRA section 3(a) states that

"[t]o the extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation limit

the distribution, sale, or use in any State of any pesticide that is not registered under this Act and that is not the subject of an

experimental use permit under section 5 or an emergency exemption under section 18." FIFRA section 8(a) states that "[t]he

Administrator may prescribe regulations requiring producers, registrants, and applicants for registration to maintain such records

with respect to their operations and the pesticides and device produced as the Administrator determines are necessary for the

effective enforcement of this Act and to make the records available for inspection and copying in the same manner as provided

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

36
in [FIFRA section 8(b)] ." FIFRA section 25(a) states that "[t]he Administrator is authorized in accordance with the procedure

described in [sec. 25(a)(2) of the Act], to prescribe regulations to carry out the provisions of this Act. Such regulations shall take

into account the difference in concept and usage between various classes of pesticides, including public health pesticides, and

differences in environmental risk and the appropriate data for evaluating such risk between agricultural, nonagricultural, and

public health pesticides." FIFRA section 25(b) states that "[t]he Administrator may exempt from the requirements of this Act by

regulation any pesticide which the Administrator determines either (1) to be adequately regulated by another Federal agency, or

(2) to be of a character which is unnecessary to be subject to this Act in order to carry out the purposes of this Act."

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

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

 View Related Documents

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 preliminary

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

37
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. 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.

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

38
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

 View Related Documents

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 users

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

39
of nanoscale materials. In addition, the program was designed to identify and encourage use of risk management practices in

developing and commercializing nanoscale materials. In its NMSP interim report, EPA identified data gaps for existing

nanoscale material production, uses, and exposures, based on the information EPA received prior to January 2009. For

example, EPA estimated that companies provided information on only about 10 percent of the nanomaterials that may be

commercially available. EPA is proposing reporting requirements under section 8(a) of TSCA for persons who are

manufacturing, importing, or processing nanoscale materials in commerce to address some of the data gaps identified in the

NMSP interim report. EPA has not identified any other activities, including regulatory activities under TSCA that would address

data gaps for existing nanoscale materials.

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

 View Related Documents

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/these

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

40
chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90

days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended

use and, if necessary, to prohibit or limit that activity before it occurs to prevent unreasonable risk to human health or the

environment.

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 Agency

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

41
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-AJ76

 View Related Documents

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 the

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

42
proposed amendment, this action addresses a perceived loophole for unethical human pesticide research to be submitted to

EPA and relied on by the Agency under other regulatory statutes.

Timetable:

Action Date FR Cite

NPRM 01/00/2011 

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

 View Related Documents

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.

Regulations.gov Monday, December 20, 2010 The Regulatory Plan

43
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 Agency

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44
Office 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

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