Drinking Water Clearinghouse
West Virginia University
PO Box 6893
How in the world does EPA make them?
On Tap Assistant Editor
Ask any drinking water operator or utility manager whats the hardest
part of their job and its likely that one of their top answers would
be understanding and complying with ever-changing federal regulations.
But ask them how the U.S. Environmental Protection Agency (EPA) sets new requirements
they have to put into place at their treatment plant and youll probably
be met with a blank stare.
Understanding some of the regulations is hard enough, let alone knowing the
complicated procedure EPA uses to develop new rules. The regulation process
involves Congress, the President, scientists, lobbyists working for special
interest groups, agency bureaucrats and technical experts (specializing in
engineering, science, public health, economics, and statistics), and the general
public. As part of the technical evaluation and analysis that goes into developing
drinking water rules, EPA must consider data and research on contaminant occurrence,
chronic and acute health effects, sensitive sub-populations, available control
technologies as well as readily available analytical methods. And even though
the process allows for input from many different groups, EPA has been severely
criticized at times for how it does set its regulations.
Giving EPA Authority
The landmark piece of legislation that gives EPA power in developing and overseeing
drinking water regulations is the Safe Drinking Water Act (SDWA). Originally
passed by Congress in 1974 to protect public health by regulating the nations
public water supply, the law was amended in 1986 and 1996, and requires many
actions to protect drinking water and its sourcesrivers, lakes, reservoirs,
springs, and groundwater wells. (See the Winter 1996 and Winter 1999 issues
of On Tap for more information about the SDWA.) The SDWA authorizes EPA to
set national health-based standards for drinking water to protect against
both naturally-occurring and manmade contaminants that may be found in drinking
water. EPA, states, and water systems then work together to make sure that
these standards are met.
EPA also gets directives from Congress, Presidential initiatives, and priorities
set by the agencys administrator. In addition to introducing a bill
in Congress, another way a representative or senator can influence the rule-making
process is by attaching ridersan amendment added to a piece of legislationto
a related or non-related bill making its way through Congress.
For instance, an influential senator may have a local or state water concern
that he or she wants EPA to address through a new or updated regulation. By
adding a directive to EPA onto an appropriation bill, its less likely
that the President will veto the legislation outright due to one of many riders
thats been attached to the larger piece of legislation that he wants
The recently contested arsenic standard is an example of a congressional rider
that is making its way through the legislative process. In this example, the
House of Representatives added a rider stipulating that the EPA immediately
adopt the Clinton Administrations standard of 10 parts per billion (later
rescinded by the Bush Administration). The U.S. Senates rider to a piece
of its legislation simply said that EPA was to immediately set a new standard
for arsenic that provides for appropriate health protection.
Because the two riders differ, a conference committee made up of members of
both the House and Senate will negotiate the final wording before it is sent
to the President for either a signature or a veto, assuming the rider makes
it out of the conference committee. Some riders are removed through negotiations
before bills ever reach the President.
Presidential Powers Enter the Mix
But Congress isnt the only player in the process. The President wields
considerable power in how EPA carries out its oversight and regulatory functions.
From an administrative and political point of view, the Presidents selection
of EPA Administrator is often seen as a barometer of how the agency will operate.
Administrators set priorities within the agency, which often dictate how the
agency will approach a regulations development.
As occurred with the change from the Clinton Administration to the Bush Administration
in January, the President can also exert his influence over regulations passed
by a previous administration. President Bush directed that all federal agencies
had 60 days to review any standards passed in the waning days of the Clinton
Administra-tion. President Bush disagreed with the Arsenic Standard as developed
by EPA and put it on hold through the 60-day review. Once EPA promulgates
a regulation (publishes a final rule in the Federal Register), 180 days must
pass before the regulation goes into effect. The Presidents hold on
regulations fell within this 180-day wait period. The House and Senates
riders arose as a direct response. Once the conference committee completes
final negotiations, well know what shape the final Arsenic Standard
SDWA Steers EPA
Under the SDWA, Congress requires EPA to review existing regulation to see
if any regulations need to be updated, which is often referred to as the six-year
review process. Congress also requires EPA to develop regulations for a specific
list of contaminants, including microbial disinfection products, radon, arsenic,
and the ground water rule. And finally congress requires EPA to address new
contaminants through a risk-based analysis of contaminants listed on EPAs
contaminant candidate list.
When EPA considers a contaminant as identified through legal requirement,
court order, Presidential initiative, or administrator priority, the SDWA
requires EPA to establish a primary drinking water standard. At its simplest,
EPA does this through a three-step process.
First, EPA identifies contaminants for regulatory consideration. To do this,
it must determine whether the contaminant may adversely affect public health,
evaluate where the contaminant occurs in drinking water with the frequency
levels of public health concern, and decide whether regulating a contaminant
poses a meaningful opportunity to reduce risk. EPA identifies these contaminants
for further study, and determines contaminants to potentially regulate. Second,
EPA determines a maximum contaminant level goal (MCLG) for contaminants it
decides to regulate. This goal is the level of a contaminant in drinking water
below which there is no known or expected risk to health. These goals allow
for a margin of safety.
Third, EPA specifies a maximum contaminant level (MCL), the highest permissible
level of a contaminant in drinking water delivered to any public water system
user. These levels are enforceable standards, and are set as close to the
MCLG as feasible. SDWA defines feasible as the level that may be achieved
using the best technology, treatment techniques, and other means that EPA
finds (after examining for efficiency under field conditions) are available,
taking cost into consideration. When it is not economically or technically
feasible to set an MCL, or when there is no reliable or economic method to
detect contaminants in the water, EPA instead sets a required Treatment Technique,
which specifies a way to treat the water to remove contaminants.
How EPA Develops Regulations
The process EPA uses to develop regulations becomes a little more complicated
when you look at the specifics. The steps the agency uses include tiering,
analytic blueprint, options development, options selection, and final agency
review. Under tiering, the EPA lead office responsible for the rulethe
Office of Ground Water and Drinking Water for drinking water regulationsassigns
the rule to one of three tiers. Tier 1 includes the rules that are the most
visible and controversial, and of most interest to the agencys administrator.
Tier 2 includes rules with extensive cross-media issues or which require extensive
Tier 1 and 2 regulations require a cross-agency workgroup and early senior
management direction. Tier 3 includes all rules not considered Tier 1 or 2.
The Regulatory Steering Committee, which consists of representatives of EPAs
assistant administrators and is approved by the Administrators Office,
receives the tier designation.
From there, the cross-agency workgroup coordinates the regulations development
and, as a first step, prepares an analytic blueprintthe plan for the
analyses, consultation, and other activities that support the regulation.
The blueprint details how EPA will gather the economic, scientific, technical,
and intergovernmental information needed to make sound decisions, as well
as the analyses required by law or Executive Order. It also addresses significant
policy issues, including implementation issues, such as the need for real-time
compliance assistance tools, as well as international factors like treaties,
transboundary or global pollution, and other countries relevant experiences.
Senior management in the program offices, and in some cases, the Administrators
Office guides the blueprint development. It is then circulated for approval
by workgroup program managers and, in the case of Tier 1 and 2 rules, senior
management. A blueprint is required for Tier 1 and 2 regulations, and strongly
recommended for Tier 3.
The next step is to develop options. To develop regulatory options, the lead
program office consults with a broad range of stakeholders, which may include
state, local, and tribal governments, industry, small businesses, public interest
groups, and others. The workgroup conducts the analyses in the analytic blueprint
and considers other issues such as disproportionate impacts on minority groups,
childrens health issues, and innovative alternatives to the regulation.
Once the options are developed, EPA management considers the scientific findings,
the relative benefits and costs, and the policy issues identified through
the various analyses and consultations. If management selects a rulemaking
option, the workgroup drafts the preamble to the rule, the proposed regulatory
text, and supporting documents.
At the end of the process, the lead office prepares a final draft and circulates
it to the workgroup for final review and approval. If the rule is in Tier
1 or 2, the Office of Policy, Economics and Innovation chairs a final agency
review meeting to assure that all issues are resolved, that all requirements
have been met, and that the rule is ready for Office of Management and Budget
review (where required) or Federal Register publication.
Stakeholders Get Involved
The 1996 amendments to the SDWA greatly enhanced the general public and drinking
water stakeholdersoperators, utilities, water association members,
environmental groups, and other drinking water professionalsinput into
the rule-making process. EPA takes comments through public meetings, presentations
at conferences, and workgroup meetings.
Jerry Biberstine, a senior environmental engineer with the National Rural
Water Association (NRWA), says EPAs openness to others input has
been helpful for small and rural drinking water utilities. Small and
rural systems have special problems that are difficult to determine when youre
just looking at large systems when writing rules, says Biberstine. Such
things as the cost of treatment and the scope of the rule are important to
small systems, so we offer EPA that insight.
We feel the impact on small systems75 percent of all systemsis
difficult for EPA to determine because they are most familiar with larger
systems and the cost impacts to them, he says. NRWA has been providing
EPA with a sense of scope, cost, and other factors that represent a small
or rural water utilitys perspective. We give them input that hopefully
helps them make regulations that are both affordable and implementable for
small water systems.
Weve been lucky to have someone sit in on almost every workgroup
on rule-writing, Biberstine says. Weve had members involved
in committee meetings and public meetings, and Rural Water has also offered
written comments to the agency. In addition were in contact with EPA
personnel directly. The American Water Works Association (AWWA) also
takes an active role in EPAs rule making. Under the direction of the
AWWA Water Utility Council (WUC) and AWWA Executive Committee, association
volunteers serve on Technical Advisory Workgroups (TAW) to participate in
developing new regulations, preparing comments on proposed regulations, and
implementing projects under the Water Industry Technical Action Fund. AWWAs
Government Affairs Division supports the activities of the WUC and TAWs and
periodically prepares status reports on upcoming regulations. In addition,
AWWA members often offer testimony to Congress and EPA about proposed legislation
Improving the Regulatory Process
Its no secret that most groups that are regulated dislike being so.
And they often disagree with the scope and impact that requirements place
on them. The federal government recognized this, and in 1996, President Clinton
issued an Executive Order instructing agencies to adhere to 12 principles
of regulation. These principles, which provide a series of guideposts
for agencies to follow in developing more focused, effective, efficient, and
less burdensome rules, were grouped into six broad themes that call on agencies
1. properly identify problems and risks to be addressed, and tailor the regulatory
approach narrowly to address them;
2. develop alternative approaches to traditional command-and-control regulation,
such as using performance standards (telling people what goals to meet, not
how to meet them), relying on market incentives, or issuing non-binding guidance
in lieu of rules;.
3. develop rules that, according to sound analysis, are cost-effective and
have benefits that justify their costs;
4. consult with those affected by the regulation, especially state, local,
and tribal governments;
5. ensure that agency rules are well coordinated with rules or policies of
other agencies; and
6. streamline, simplify, and reduce the burden of federal regulation.
EPA Is Criticized
But just because a federal agency says it is being more accountable and less
burdensome to the community it regulates doesnt always sit well with
those facing compliance issues with new or more stringent regulations. Aside
from those stakeholders being regulated, EPA officials have also criticized
the agency. In 1996, David Lewis a researcher with the EPA National Exposure
Research Laboratory in Athens, Georgia, wrote a commentary in the Athens Banner-Herald,
that the EPAs environmental policies were misguided.
Lewis guest column read, in part, that federal regulators assume
that everything humans do will ultimately harm the environment. Therefore,
they promulgate regulations aimed at making it extraordinarily difficult and
expensive to do anything that changes the environment in any way. EPA
investigated Lewis for alleged ethics violations as a result of the commentary.
Investigators looked into whether an editors note in Lewis column
violated a rule because it over-emphasized his position with the agency.
In June 2000, David Paris testified before Congress where he offered a number
of criticisms of EPAs work in implementing the 1996 SDWA amendments.
Paris, a water supply administrator with the Manchester Water Treatment Plant
in Manchester, New Hampshire, spoke on behalf of the AWWA. While complimenting
EPAs Office of Groundwater and Drinking Water for involving the public
in developing regulations, he noted that, AWWA does have a major concern
that EPA is not conducting essential research and developing new data to support
drinking water regulations as expected in the 1996 SDWA Amendments.
There is also a long-term concern that the authorizations for the new
drinking water state revolving fund will not be adequate to address the needs
identified to comply with SDWA regulations and upgrade drinking water infrastructure
to ensure that high quality safe drinking water is provided to the American
NRWAs Jerry Biberstine says one of the biggest problems EPA has with
rulemaking is the amount of time it has to consider sound science that shows
the benefits and the cost of the rules. Its the time frame that
is the problem, he says. Congress forces EPA to address all the
concerns of a proposed regulation in a short amount of time. I fault the process
rather than EPA. They are under considerable pressure.
EPA Recognizes Problems
EPA itself recognized problems and that its regulatory process needed to be
improved. In a June 2001 EPA Task Force Report titled Improving Regulations,
the agency acknowledged problems and ways to improve the process, primarily
the quality of supporting scientific, economic, and policy analysis. The report
said that EPA needed, better science and economic analysis, broader
consideration of policy options, and greater accountability.
EPA acknowledged that, It is absolutely essential that EPA leaders have
the best possible scientific and economic information to consider when making
decisions. But its important to note that science and economics are
only two of the many factors that must be considered. Other factors might
include implementation by states or local governments, disproportionate impacts
on low income communities, the limitations of available technology, or whether
a certain approach can actually be enforced. The role of science and economics
is, therefore, to inform the decision making, not to dictate the final decision.
Regulations Affect Small Systems
Mike Keegan, an analyst with the NRWA, says that small and rural water systems
often face the brunt of regulations and may not have the resources to cope
with them. We try to advocate for the small towns best interest
and help EPA look at the big picture, he says. A lot of their
rules dont apply to small communities. Small communities problem
is a resource problem rather than a regulatory problem. EPA comes at it with
a regulatory solution saying a system needs to meet a standard and then they
fine you if you dont comply with that standard. Were saying small
utilities need the resources to correct the problems, not a regulationand
usually we are not talking about water quality problems, but rather administriatve
Keegan says that the current EPA rulemaking process also doesnt allow
for much leeway for locals to make decisions. The people who run the
towns water system and the local community should have some choice in
the matter, he says. The SDWA is blind to nuances at the local
Lets say that when the new arsenic regulation is finalized it
allows only 10 parts per billion and a certain towns water tests at
10.5 parts per billion. In the gray area like this, I want the local community
to have more control on the issue rather the requirements be set in stone,
Keegan says. They should have some say as to whether they want to install
an expensive treatment process for 0.5 parts per billion. Scientists cant
claim that their water would be any safer having that small amount removed.
If you went out and told them (small utilities) what they needed to
do to improve their water and make it sensible, then they could take care
of their problems much easier, Keegan says. Regulations just dont
fit. We try to get in there (the rule-making process) to hopefully make sure
the rules dont do any harm. I think one of the biggest problems
has been the environmental groups constantly misleading the public on who
is in control of their local water quality, continues Keegan. A
local community has complete control over quality issues, however, big environmental
groups promote the image of a sinister force attempting to harm your family.
They should be educating the public on civics and how to empower locals to
better make local decisions instead of always removing local authority and
replacing it with federal authority.
We have an open challenge to the green groups: If they can get the local
votes to implement any of their policies we would back them 100 percent. However,
the reality is that locals dont back their agenda so they need to override
the local will with EPA authority.
For more information about EPAs regulatory process, visit the
Office of Ground Water and Drinking Waters Web site at www.epa.gov-/OGWDW/
or call the Safe Drinking Water Hotline at (800) 426-4791.
For more information about NRWA, visit their site at www.nrwa.org
or call them at (580) 252-0629.