A Vital Tool for Protecting Public Health and the Environment
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THE ORIGIN OF REGULATIONS: ENVIRONMENTAL
LAWS . .2
DEVELOPING REGULATIONS:
FROM START TO FINISH .
.4
IMPORTANT CONSIDERATIONS THAT GUIDE
DECISION-MAKING
.7
WHEN REGULATION Is NOT NEEDED .16
IMPROVING THE PROCESS: SETTING THE STAGE
FOR FUTURE REGULATORY ACTIONS . . 19
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A Vital Tool for Protecting Public Health
and the Environment
What does it take to protect the
world around us? Everyone
doing their share. Look around
your community and you will find volun-
teers starting recycling programs, clean-
ing up streams, and planting trees. This
same spirit of environmental stewardship
can also be seen in the private sector,
where companies are adopting green
business practices that are good for the
environment and the bottom line.
The U.S. Environmental Protection Agency (EPA) encourages vol-
untary efforts for protecting the environment, but we also have
the authority to write mandatory requirements called regulations.
EPA regulations cover a range of environmental and public health
protection issues, from setting standards for clean water to speci-
fying cleanup levels for toxic waste sites to controlling air pollu-
tion from industry and other sources.
Businesses, state and local governments, even individuals can be
fined if they do not abide by our regulations, and that is one rea-
son why we invite the public to share in their development—we
want our rules to be practical and fair for the American people.
Continue reading to learn more about how EPA writes regula-
tions, and how your voice can influence the policies that shape
our environmental future.
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Environmental Laws
Typically, Congress learns about an environmental or public
health protection issue before EPA writes the regulations to
address it. Public interest groups, citizens, businesses, or other
government agencies contact Congress with an issue of concern.
Congress may then decide to hold hearings and prepare a bill. If the
bill gains approval in Congress, it then goes to the President for sig-
nature. If signed, the bill becomes a law.
However, most laws do not have enough detail to be put into practice
right away. EPA is called a regulatory agency because Congress author-
izes EPA to write regulations that explain the critical technical, opera-
tional, and legal details. For example, the Resource Conservation and
Recovery Act requires EPA to write standards for managing hazardous
waste. Its central mandate requires EPA to develop standards to "pro-
tect human health and the environment" but does not say precisely
what those standards should be. As in many other laws, Congress
entrusts EPA to develop most of the details for regulations based on
our technical and policy expertise.
The box to the right lists the laws that give EPA most of its authority
to write regulations. These laws are designed specifically to achieve
the nation's environmental and public health protection goals.
In a single year, EPA publishes about 1,000 regulations in either pro-
posed or final form. Of these regulations, only about 5 to 10 are con-
sidered major, meaning they have the potential to impose cumulative
costs of more than $100 million a year.
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Congress passed the following laws specifically to protect human health and the
environment. Many of these laws have been amended si nee the dates of their
enactment to reflect new scientific knowledge or to correct ambiguities.
1938 Federal Food, Drug, and
Cosmetic Act
1947 Federal Insecticide, Fungicide,
and Rodenticide Act
1948 Federal Water Pollution Control
Act (also known as the Clean
Water Act)
1955 Clean Air Act
1965 Shoreline Protection Act
1965 Solid Waste Disposal Act
1970 National Environmental
Policy Act
1970 Pollution Prevention
Packaging Act
1971 Lead-Based Paint Poisoning
Prevention Act
1972 Coastal Zone Management Act
1972 Marine Protection, Research,
and Sanctuaries Act
1972 Ocean Dumping Act
1973 Endangered Species Act
1974 Safe Drinking Water Act
1975 Hazardous Materials
Transportation Act
1976 Resource Conservation and
Recovery Act
1976 Toxic Substances Control Act
1977 Surface Mining Control and
Reclamation Act
1978 Uranium Mill-Tailings Radiation
Control Act
1980 Asbestos School Hazard
Detection and Control Act
1980 Comprehensive Environmental
Response, Compensation and
Liability Act
1982 Nuclear Waste Policy Act
1984 Asbestos School Hazard
Abatement Act
1986 Asbestos Hazard Emergency
Response Act
1986 Emergency Planning and
Community Right to Know Act
1988 Indoor Radon Abatement Act
1988 Lead Contamination Control Act
1988 Medical Waste Tracking Act
1990 National Environmental
Education Act
1990 Pollution Prevention Act
1996 Food Quality Protection Act
1999 Chemical Safety Information,
Site Security and Fuels
Regulatory Relief Act
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Developing
'gulations:
From Start to Finish
When EPA identifies the potential need for a regulation, staff
meet to form a workgroup. The workgroup is led by the EPA
office that will be writing the regulation and includes mem-
bers from other parts of the Agency with related interests or responsi-
bilities. This process can take months before an appropriate course of
action is carefully and methodically decided. It generally goes like this:
• Analyze the Problem. The workgroup studies the origin, magni-
tude, and impacts of the problem. It may draw information from
EPAs own research, scientific literature, or from other researchers
in the United States and abroad.
• Identify Options. The workgroup then considers the available
options for addressing the problem. This may require evaluating
environmental technologies, changes in environmental manage-
ment practices, and incentives that can motivate better environ-
mental performance. As later sections explain, the workgroup also
takes related issues into account at this stage, such as the impact
of various options on small businesses, on children's health, or on
state and local governments. Sometimes the workgroup might
find there is no need for regulation.
• Publish Proposal. Once the preliminary analysis is complete and
the need for regulation is determined, the workgroup drafts a pro-
posed regulation for publication in the Federal Register. A law
called the Administrative Procedure Act generally requires EPA
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(and other federal regulatory agencies) to request comments from
the public before finalizing the regulation. The public comment
period typically lasts 60 to 90 days.
Review Public Comments. Next, the workgroup reviews and
evaluates all the comments received. Depending on the regula-
tion, these comments may range from minimal to extensive. In
any case, the workgroup carefully weighs and evaluates the com-
ments before developing a draft final regulation for review and
approval by EPA senior management.
Issue Regulation. After approval by senior management, the EPA
Administrator reviews the draft regulation and decides whether it
should be issued. If the Administrator decides to issue the regula-
tion, it is published in the Federal Register and goes into effect
soon afterwards. In accordance with the Congressional Review
Act, Congress may overturn a regulation even after the
Administrator has issued it, however, this is an exrememly rare
occurrence.
Sharing the Game Plan: EPA's Regulatory Agenda
Like all federal regulatory agencies, EPA publishes a list of the
important regulations that will be completed within the next year.
This "Semi-Annual Regulatory Agenda" appears in the Federal Register
in the spring and fall, serving as an official notice for all interested
parties.The Agenda also includes information about important
regulations completed within the past year.
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Occasionally there are interim steps in this process. For instance, if
the workgroup receives new data from the public during a comment
period, the workgroup might publish in the Federal Register a "Notice
of Data Availability" so interested parties can learn more and submit
additional comments. Sometimes the workgroup might decide to take
a new direction after receiving new data, which can result in a
"Supplemental Notice of Proposed Rulemaking." Finally, the work-
group might decide to draft a notice seeking public comment and
information before the proposal is even developed. This pre-proposal
is called an "Advanced Notice of Proposed Rulemaking" and is also
published in the Federal Register.
EPA maintains a central staff within the Administrator's office to track
all the regulations under development. The Regulatory Management
Staff monitors the status of workgroups, helps with Federal Register
publication, and ensures that EPA is following the various laws and
mandates that govern regulation writing.
Because EPA is part of the Executive Branch, the White House's Office
of Management and Budget (OMB) reviews some EPA regulations
before they are published in the Federal Register. Generally, OMB
reviews regulations that could potentially impose more than $100
million in annual costs on society or present controversial legal or
policy issues. OMB also ensures rules are consistent with the
Administration's environmental priorities and policies, and coordi-
nates review by other federal agencies that might have an interest in
the issue.
Making It Official—Where To Look for Regulations
EPA publishes its proposed regulations,final regulations, and notices in
the Federal Register. Final regulations are also published in the Code of
Federal Regulations. Known as the CFR, this compilation of government
regulations is divided into 50 titles that represent topics of federal
authority, such as education, transportation, and agriculture.The CFR
contains environmental regulations mainly in Title 40 Chapter I (Parts
1 -799), Chapter V (Parts 1500-1517), and Chapter VI (Part 1700).
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Important
Considerations
"hat Guide Decision-Makin1
A quick glance at the steps just outlined may lead some to
believe that regulation development is a straight-forward
process. But our job is to produce quality regulations that
are scientifically sound, cost-effective, fair, and effective in achieving
environmental goals. And so we routinely take diverse and often
complex issues into account before making final decisions. Some
of the most influential factors on our decision-making are discussed
below.
Using Sound Science
All of EPAs work is supported by sound science, especially our work
on regulations. Whether we are developing a new standard to protect
the public from a newly recognized risk or specifying monitoring
requirements to gauge how well an environmental control is working,
EPA bases its regulations on the most current and credible scientific
information available. This information might come from EPAs own
research laboratories, or from literature reviews that help pinpoint
useful research from other sources.
Under the best circumstances, EPA uses information that has under-
gone thorough peer review. During peer review, leading experts verify
the accuracy of data and any resulting conclusions. Sometimes, how-
ever, the need for immediate action leads EPA to rely on data that are
preliminary or that present conflicting results. In these instances, EPA
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uses it expertise to draw reasonable conculstions based on what is
already known.
In addition, we often rely on outside expertise to review research
results and inform our scientific judgments. Most notable is EPA's
Science Advisory Board. Composed of outside experts from various
scientific disciplines, representing academia, industry, and environ-
mental organizations, this distinguished group generally serves as a
technical review panel, providing EPA with sound advice on impor-
tant science issues that might affect the development and implemen-
tation of a regulation. Outside expertise may also come from the
National Research Council, other federal agencies with related
responsibilities, or other outside experts.
Because sound scientific data are so critical to quality actions, EPA
conducts its own research and provides support to researchers out-
side the Agency. Many studies examine the effects of pollutants and
other environmental stressors on human health and the natural envi-
ronment, how harmful effects occur in the body, and the health risks
they represent. Some of the issues currently under investigation at
EPA include the impacts of global climate change on ecosystems, the
effects of the chemical dioxin on human reproduction, and the poten-
tial vulnerability of the nation's drinking water supply. These studies
are part of a broader research agenda that provides critical support for
EPAs regulatory work.
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Following Laws and Executive Orders
Besides carrying out directives in environmental laws, EPA must
abide by several laws and executive orders (E.O.s) that guide the
process for developing regulations at the federal level. These man-
dates, shown on the next page, direct EPA to consider issues of con-
cern to the President, Congress, and the American public.
Economic Benefits and Costs
Before drafting a regulation, EPA assesses the expected benefits and
costs. Consistent with E.O. 12866 on regulatory planning and review,
EPA performs economic analyses using a set of principles that make
the regulatory system work well for the American people. These
analyses call for EPA to assess the benefits and costs of the regulatory
alternatives available, including the alternative of not regulating. EPA
regulation writers use quantitative (numerical) and qualitative
(descriptive) measurements to gauge the benefits and costs of impos-
ing a regulation.
But how do you put a dollar value on the benefits of nature? If wet-
lands are filled in because there is no regulation to protect them,
what is the loss to society? How do you fully measure the cost that
society incurs from some degree of exposure to a cancer-causing
chemical? As difficult as these questions seem, economists have
developed methods to make prudent estimates about the benefits and
costs of environmental regulations.
We estimate benefits in several ways. Human health benefits might
include reduced mortality rates and fewer incidences of cancer or
chronic illnesses. Ecological benefits might include restoration of
degraded habitat and increases in populations of certain species.
Other benefits reflect quality-of-life factors, such as improved taste
and odor of drinking water.
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\
...ECUTIVE ORDERS THAT
GOVERN FEDERAL RULEMAKING
The Administrative Procedure Act
The Regulatory Flexibility Act (as amended
by the Small Business Regulatory
Enforcement Fairness Act)
The Unfunded Mandates Reform Act
The Paperwork Reduction Act
The National Technology Transfer and
Advancement Act
The Congressional Review Act
E.0.12866 on regulatory planning and
review
E.0.12898 on federal actions to address
environmental justice in minority popula-
tions and low-income populations
E.0.13045 on protection of children from
environmental health risks and safety risks
E.0.13132 on federalism
E.0.13175 on consultation and coordina-
tion with Indian tribal governments
E.0.13211 on regulations that significantly
affect energy supply, distribution, or use
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We estimate the cost of a regulation by looking at the cost of compli-
ance. A new regulation often forces businesses, communities, non-
profit organizations, or government agencies to buy new pollution
control equipment or adopt new practices. Other costs include social
welfare losses, such as higher consumer and product prices, and tran-
sitional social costs, such as business closings and unemployment.
EPA's "Guidelines for Preparing Economic Analysis" provides a sound
and consistent framework for measuring benefits and costs of regula-
tory options. Recognizing the need to focus our analytical efforts
where they are most useful, EPA applies its most rigorous analyses to
the "economically significant" regulations—those that we expect to
cost society more than $100 million a year.
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Although estimates of benefits and costs are ordinarily essential to our
work, occasionally some laws prescribe an approach that actually pre-
vents EPA from taking costs into account. For example, the Clean Air
Act does not allow EPA to consider the economic costs of implemen-
tation when developing National Ambient Air Quality Standards.
These standards define the maximum allowable levels of certain pol-
lutants in our atmosphere, and when Congress amended the Clean
Air Act in 1970, it intended for EPA to act without considering how
much it would cost or even whether it was technologically feasible.
Congress understood that this approach might impose unusual bur-
dens on society, for example by forcing the development of new con-
trol technologies, but decided to put protection of public health and
welfare ahead of economic considerations.
Small Businesses and Small Communities
EPA routinely looks closely at how rules might affect small businesses
and small towns. Compared to larger organizations, these small enti-
ties often do not have the resources needed to completely manage
their environmental responsibilities. Therefore, under the Regulatory
Flexibility Act (as amended by the Small Business Regulatory
Enforcement Fairness Act), Congress directs EPA to take the impacts
of its proposed regulations on small entities into account. Specifically,
unless the EPA Administrator can certify that a regulation will not
have a significant economic impact on a substantial number of small
entities, EPA generally must:
• Convene a small business advocacy review panel. The panel
examines the economic impact of the proposed regulation on small
entities, reaches out to small entities for comments, and prepares a
report summarizing both the comments and the panel's recommen-
dations. The comments become part of the official record, and EPA
factors the recommendations into its decision-making.
• Prepare a regulatory flexibility analysis. This analysis describes
the impact of the proposed regulation on small businesses. It also
outlines alternatives that could accomplish the same objective while
minimizing the significant economic impacts.
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Together these actions ensure that EPA fully considers the impacts of
its actions on small entities and ways to minimize those impacts as
much as possible. One example of how this affects our regulations is
the rule for regulating the injection of certain liquid wastes into under-
ground wells. Some wastes from vehicle repair and maintenance shops
receive little or no treatment before injection into the ground, which
can lead to groundwater contamination. When EPA issued a regulation
halting use of injection wells at these operations, we did so based on
input from environmental groups and other affected stakeholders and
with the knowledge that it could have a significant economic impact
on 4,800 small businesses and 380 small towns. And so to lessen this
impact, we used a phased approach whereby well owners have about
seven years to comply. The regulation also allows owners and opera-
tors to seek a waiver from the ban and get a permit to continue opera-
tions as long as certain conditions for environmental and public health
protection are met.
Environmental lustice and Child Safety
Protecting public health means protecting the health of all Americans,
including those segments of society that might need more attention
than others. In recent years, public concern that some populations
were bearing an uneven share of environmental health risks led to E.O.
12898 that requires "federal actions to address environmental justice in
minority populations and low-income populations." This executive
order calls for EPA to identify and address impacts on minority and
low-income populations when we develop our regulations.
Additionally, EPA considers how regulations might impact children.
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In relation to their body size, children breathe more air, drink more
water, and eat more food than adults, so their exposure to environ-
mental health risks is greater. In the past, EPA regulations considered
health risks to adults almost exclusively. But as new information
emerged suggesting that children are more vulnerable to health risks,
EPA began altering its approach to risk analyses. E.O. 13045 "on pro-
tection of children from environmental health risks and safety risks"
strengthened our focus on children, requiring us to analyze whether
certain regulations would have disproportionate impacts on their
health.
Providing Flexibility
Often, the biggest complaint about regulations—and not just envi-
ronmental ones—is that they can be too rigid. In particular, compa-
nies sometimes argue that by mandating specific solutions, EPA regu-
lations stifle innovation that could lead to better environmental
results. By pursuing innovative approaches and insisting on strong
accountability for results, we are finding ways to build more flexibili-
ty into regulations.
One way EPA does so is by using performance-based approaches that
emphasize the end result we want to achieve. For example, an air
quality regulation directs heavy-duty diesel trucks and buses to cut
sulfur emissions by 95 percent. The regulation does not specify how
refiners and engine manufacturers must achieve this goal, but it does
give them significant time to decide for themselves. In other
instances, EPA has offered companies extra time to comply with a
new requirement if those companies were willing to invest in more
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advanced technologies than required. This approach means better
protection for the environment and more flexibility in making envi-
ronmental investment decisions.
EPA works with states, businesses, and other organizations with envi-
ronmental interests to test approaches that can lead to more flexible
regulations. The objective is to find more efficient and effective ways
of achieving environmental goals and to then apply those approaches
on a scale that produces the greatest possible benefits. One innovative
approach that has proven effective is the use of facility-wide permits
that put a cap on overall emissions rather than specifying limits for
every emission source at a site. This approach gives companies more
flexibility in managing their operations, and it reduces regulatory
burden.
Involving the Public
Many individuals outside the government are affected by and interest-
ed in environmental regulations. These stakeholders often provide
valuable comments on EPA's proposed regulations. Stakeholder com-
ments can illuminate issues that EPA has not yet considered, allowing
us to benefit from the knowledge and experience of the concerned
public. Ultimately, stakeholder comments lead to better regulations.
When EPA proposes a regulation in the Federal Register, the Agency
includes information about how the public can comment. Options
include sending comments via regular mail, e-mail, or fax. We
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encourage stakeholders to tell us where they stand on a proposed reg-
ulation and to send information and data that support their position.
For most regulations, EPA saves public comments in a docket. The
docket organizes information related to each regulation, including
background reports, Federal Register notices, and other supporting
documents. Each docket is accessible to the public. Check the final
page of this publication to find out how you can visit our online
EDOCKET system, which allows users to send comments and access
docket materials electronically.
Federal advisory committees also provide EPA with advice and rec-
ommendations. Sometimes EPA will establish a federal advisory com-
mittee to get advice on a particular issue. However, EPA convenes the
following committees on a routine basis to get advice on issues that
cut across EPA programs:
• The EPA Science Advisory Board provides EPA with feedback on
the scientific underpinning of its decision-making.
• The National Advisory Council for Environmental Policy and
Technology advises EPA on ways to improve our domestic and
international environmental management policies, programs,
and technologies.
• The Environmental Financing Advisory Board provides EPA
with advice on how regulations should be paid for once they
go into effect.
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When
Regulation
16
Sometimes EPA finds that a regulation is not needed after all.
While developing a new regulation, we periodically assess the
latest information to reaffirm our approach. If the evidence sug-
gests that a proposed regulation is unnecessary or inappropriate, we
may abandon the issue or choose an alternative course of action.
Such was the case for a proposed wastewater regulation targeting pol-
lution from industrial laundries. After reviewing new information
about the toxicity and volume of pollution from the laundries, EPA
decided that local wastewater authorities could more effectively
address the problem. Consequently, EPA began to work with industry
on a voluntary pollution prevention program aimed at reducing pol-
lutants to the air, water, and land.
Although EPA believes that regulations play an irreplaceable role in
environmental and public health protection, there are some circum-
stances where we can achieve superior environmental results using
alternatives. Some of these alternatives are described below:
• Voluntary programs. Today, EPA has more than 30 voluntary
national programs to help companies and other organizations
improve specific aspects of environmental management. For exam-
ple, ENERGY STAR® promotes energy efficient products and practices;
Design for the Environment helps companies find more environ-
mentally sound alternatives to existing processes or technologies;
and the Commuter Choice5" Leadership Initiative works with
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employers to reduce greenhouse gas emissions by offering com-
muter benefits to employees. EPA has many other voluntary pro-
grams that address regional priorities.
Economic incentives. Used to link environmental and economic
goals, economic incentives can take many different forms. For
example, pollution fees charged by volume create an incentive for
companies to reduce waste. Market-based trading programs, such
as those used successfully to control acid rain, give companies the
option to buy or sell pollution credits, depending upon their cir-
cumstances. Subsidies offer financial aid for environmental invest-
ments that might otherwise prove too expensive. And liability rules,
such as those used in the federal Superfund program, create an
incentive for businesses and communities to address environmental
management issues before they become a problem.
Partnerships. EPA often works with other organizations to share
ideas and leverage resources, achieving more environmental protec-
tion than we could ever achieve through individual effort—or regu-
lation—alone. These partnerships involve other agencies and levels
of government, universities, non-profit and community groups, and
private companies. From scientific research to information sharing,
environmental partnerships can be a powerful tool for accomplish-
ing specific goals. For example, in 2001, EPA launched a new pub-
lic education campaign in partnership with the Ad Council and
Major League Baseball that alerts parents of asthmatic children
about the dangers of second-hand smoke in the home—a problem
that would be difficult to regulate and impossible to enforce.
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• Technical assistance. EPA believes that businesses and other
organizations require tools to improve their environmental per-
formance. We offer assistance on the Internet, during onsite visits,
via telephone hotlines, and through training efforts. For example,
EPA funds job training programs to clean up brownfields—aban-
doned or underused industrial and commercial properties that
remain undeveloped because of concern about potential contami-
nation. The training allows communities to speed up cleanup and
redevelopment efforts and, as a bonus, helps prepare local residents
for future employment in the environmental field.
As EPA looks beyond traditional "command and control" regulations
and toward creative approaches to environmental problem-solving,
we benefit from the diverse skills of our staff. As you would expect,
EPA has many employees with science, engineering, and law degrees.
But you will also find staff with degrees in business, statistics, sociolo-
gy, education, and public policy. This diversity of knowledge and
experience is useful in our problem-solving, whether it involves regu-
lation—or not.
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Improving the
Setting the Stage for Future Regulatory Actions
EPA began issuing regulations shortly after opening its doors in
1970. Since then, we have learned a great deal about working
with stakeholders and running a sound regulatory development
process. We have learned the process is dynamic—often requiring
continual adjustments in both substance and process. For example,
we are learning to harness the power of the Internet—the EDOCKET
system mentioned previously allows stakeholders to go online and
submit comments on proposed rules. Similarly, new electronic report-
ing capabilities now under development will provide regulated facili-
ties with a quick, efficient, and paperless option for complying with
reporting requirements.
Recognizing the critical role that regulations play in achieving its mis-
sion, in April 2001, EPA launched a comprehensive review of the reg-
ulatory process. This review—the first in many years—resulted in
recommendations that will strengthen our regulatory actions. The
recommendations are designed to get EPA managers, scientists, and
economists more actively involved in developing quality regulations,
to ensure workgroups consider different policy options before making
decisions, and to increase public participation.
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EPA will continue pursuing improvements that can improve environ-
mental regulations. Because our responsibilities do not end once a
rule appears in the Federal Register, we continue to work with the
businesses and communities that are bound to put them into prac-
tice. Technical assistance, monitoring, compliance assurance,
and enforcement are all equally important parts of the regulatory
process, even though occurring later. And so, while the focus of this
brochure is on how regulations are developed, to achieve the intend-
ed benefits, EPA works with affected parties long after requirements
take effect.
Moreover, in order to move towards a cleaner future, EPA will contin-
ue to rely on the American people to do their part—by getting
involved with our regulatory actions and by volunteering and pro-
moting environmentally friendly actions in their businesses, commu-
nities, and homes.
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FOR MORE INFORMATION
You can learn more about environmental regulations by calling
EPA's Regulatory Management Staff at 202 564-5480. You can
also visit EPA's Web site at and click on "Laws
and Regulations." Additional Web sites relating to specific regula-
tory issues and resources described in this document are high-
lighted below:
Children's Health
Code of Federal Regulations
(Title 40)
www.epa.gov/children
www.epa.gov/epahome/
cfr40.htm
Environmental Laws
www.epa.gov/epahome/
laws.htm
E-Docket
Environmental Economics
Environmental Justice
Innovative Approaches
Federal Register
Science Advisory Board
Small Business
ww.epa.gov/edocket
www.epa.gov/economics
www.epa.gov/compliance/
environmentaljustice
www.epa.gov/innovation
www.epa.gov/fedrgstr
www.epa.gov/sab
www.epa.gov/smallbusiness
Voluntary Programs
www.epa.gov/partners
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