Clean Water Advocacy - Newsroom - AMSA in the News
No. 121
Monday, June 24, 2002 Page A-11
ISSN 1521-9402
News
General Policy
EPA Proposed Guidance on Data Quality Draws Fire From Industry, Advocacy Groups
The Environmental Protection Agency's proposed guidelines for ensuring the
quality of the data it disseminates contain inadequate provisions to achieve
that goal and will lead to regulatory gridlock and numerous lawsuits, according
to comments filed by industry and activist organizations prior to the June 21
comment deadline.
Comments from myriad industries shared several themes. Nearly all firms and
trade associations stressed that EPA's proposal exempted far too much
information from the proposed guidelines, and that EPA allowed itself far too
many loopholes to avoid compliance.
Environmental and consumer advocates stressed their fear that industries will
use the guidance to haul EPA into court and otherwise thwart agency actions
designed to protect the environment and public health.
Comments from local, state, and congressional officials covered a broad range of
issues. For example, the City of Peoria hopes the guidance will lead to more
accurate drinking water data being posted on EPA's Web site, so that city
officials will stop getting calls from upset customers.
EPA developed the guidance under the direction of the White House Office of
Management and Budget, which told federal agencies to develop agency-specific
guidance describing how they would ensure the usefulness, accuracy, unbiased
nature, and other quality aspects of data they disseminate.
OMB also told agencies to develop procedures by which individuals or
organizations could challenge information they assert fails to meet the
data-quality standards. OMB issued this directive to fulfill a requirement in a
2001 appropriations bill. The statutory provision ordering OMB to take this
action has been dubbed the "Data Quality Act."
John Graham, head of OMB's Office of Information and Regulatory Affairs, who
helped write the OMB directive to agencies, told BNA June 20 that OMB intends to
work with agencies to ensure that doom and gloom scenarios predicted by
commenters do not come true. Agencies must implement the guidance by Oct. 1.
Possible Challenge to Air Data
Many companies and trade associations addressed the issue of whether EPA's
compliance with the data-quality guidance is legally binding, meaning they could
sue the agency for allegedly not following its guidance.
EPA has said the guidance is just that--guidance, not a regulation, and hence
compliance is not judicially reviewable.
"EPA's guidelines implement the Data Quality Act. They therefore constitute
rules, rather than guidance, and are legally enforceable," said the U.S. Chamber
of Commerce. "[T]he issue of judicial review will ultimately be decided by the
courts."
William Kovacs, vice president of environment and regulatory affairs at the
chamber, told reporters June 21 that the chamber is considering filing a lawsuit
to challenge data EPA used as it determined in 1997 to tighten air pollution
emissions to reduce ozone and particulate matter.
The Health Effects Institute announced May 30 that the Johns Hopkins University
researchers who developed the data had identified a number of errors in it and
may have overstated the mortality rate associated with particulate air pollution
by up to 100 percent (110 DEN A-10, 6/7/02 ).
The American Lung Association urged EPA to make it clear that compliance with
the data-quality standards and agency decisions not to correct information are
not judicially reviewable.
Correcting Rulemaking Information
Another focus of much industry comment was whether individuals and organizations
can use the data-correction process to seek changes in allegedly erroneous data
contained in a proposed rule.
EPA has said it would use existing procedures rather than the new
data-correction process.
EPA's proposal "could, as a practical matter remove all EPA rulemaking records
from coverage under the Data Quality Act. This exclusion is contrary to the
letter and intent of the Act," said the Center for Regulatory Effectiveness,
which helped write the law that required the data-quality guidance.
In a June 10 memo to federal agencies about their proposed strategies to
implement OMB's data-quality guidance, Graham urged agencies to describe
circumstances in which they might respond to a request to correct data used in a
rulemaking earlier than they would if using existing methods, such as removing
the error from the final rule.
The Natural Resources Defence Council (NRDC) urged EPA to retain its proposal to
address problems raised about information in rulemakings through existing
procedures.
Concerns Over Exemptions
Industry commenters urged EPA to ensure that much more information is covered
under its final guidance than it proposed to cover.
The section of EPA's proposal that lists exempted information "is the longest
section in the Guidelines," wrote Mark Greenwood, an attorney with Ropes & Gray.
He filed comments on behalf of the Coalition for Effective Environmental
Information, which represents chemical, energy, automobile, pharmaceutical,
forest product, petroleum, and other industries.
The agency's exemptions are fundamentally flawed because EPA has based many of
them on the form in which information is disseminated rather than on the intent
of the information.
For example, letters, which are exempted under EPA's guidance, may have
important statements of the agency's position on a particular issue, the
coalition said.
More Information Said to Be Influential
Many industry commenters also urged EPA to broaden its definition of information
deemed influential.
Under OMB's guidance influential information is subject to greater scrutiny. For
example, the data must be reproducible by third parties. The reproducibility
standard can be met in a variety of ways.
"All Agency 'information' should be considered influential," wrote the
Association of Metropolitan Sewerage Agencies.
Writing on behalf of the General Electric Co., Thomas Richichi, an attorney with
Beveridge & Diamond, urged EPA to provide in its final guidance examples of
influential information. Items Richichi said should be deemed influential
included:
information contained in EPA's Integrated Risk Information System, a database
that contains the agency's consensus conclusions about health risks posed by
chemicals, pesticides, and other agents;
chemical classifications used by EPA, such as the agency's list of persistent,
toxic and bioaccumulative agents;
human health and ecological risk assessment guidelines;
site-specific risk assessments for cleanups; and
models and other "information products" designed to describe the risks posed by
facilities or environmental conditions.
The chamber said influential should not be equated with a specific economic
impact, such as information expected to have a $100 million impact, which is
part of the definition of major rule.
NRDC urged EPA to defer designating any information as influential until a
data-correction request is made or a final action is taken.
EPA must detail in its final guidelines the procedures it will use to determine
whether information should not be released due to privacy, trade secret,
intellectual property, or confidentiality concerns, the chamber said. The final
guidance also must say how EPA will ensure that program and regional offices
will protect such information, the chamber said.
Broader Application of SDWA Principles Urged
Many industries and Rep. W.J. "Billy" Tauzin (R-La.) urged EPA to adopt
principles from the Safe Drinking Water Act for all of its risk assessments.
Tauzin helped write that law.
OMB told agencies that assess health, safety and environmental risks to either
adopt or adapt the SDWA principles.
The SDWA required EPA to use the best available science. It also told the agency
to generate central risk estimates (often the agency presents risks as a range)
and to identify peer-reviewed studies that draw conclusions about risk that are
different from those reached by the agency.
EPA proposed to adapt those principles to human health risk assessments and
asked for comment on how it should handle environmental and safety risk
assessments.
"EPA's proposal would be inconsistent with law and it leaves completely
open-ended loopholes for EPA not to follow the SDWA principles or any principles
of objectivity," Tauzin said.
The American Chemistry Council, which represents major U.S. chemical companies,
urged EPA to establish a presumption that it will apply the SDWA principles
across the board, except in particular cases where doing so is not practical for
some reason.
Limited Application of SDWA Principles Urged
NRDC applauded EPA for not adopting the SDWA provisions.
The SDWA language on risk assessment would make risk the determining factor in
the agency's decision to act. "If the risk assessment determines that the risk
is small, rather than erring on the side of caution, we would refrain from
acting," NRDC said.
That would effectively repeal crucial provisions of the Clean Air Act, the Clean
Water Act, and other statutes EPA implements, NRDC said.
The American Lung Association also urged EPA not to apply the SDWA provisions to
any other statute.
Deadline Urged
Another issue on which many industries shared agreement included requests that
EPA provide a deadline by which it would respond to a request to correct data
and appeals of decisions not to do so.
In his June 10 memo, Graham said "Each agency must state in its guidelines the
time periods for making decisions on both complaints and also on any appeals."
Many industries also urged EPA to develop a process by which it will review
information prior to dissemination to ensure that it meets the data-quality
standards.
"The final guidelines must lay out in specific detail an understandable
predissemination process," said the American Chemistry Council. "Compliance with
the information quality guidelines must be considered at every stage in the life
cycle of an information product."
The environmental information coalition urged EPA to better explain how it will
implement all aspects of OMB's guidance.
For example, OMB told agencies to ensure the integrity of their information,
meaning, for example, that a computer hacker should not be able to access and
alter government information.
Challenges to Security, Usefulness Predicted
"[I]t is also important for EPA to recognize that the integrity standard can be
the subject of a correction request by private parties," the Coalition for
Effective Environmental Information said. "If a data submitter has reason to
believe that the security of data held by the agency has been, or may be
compromised, it is appropriate for the submitter to seek corrective action
through the corrections mechanism."
OMB also said federal information should be useful. Parties may challenge
information asserting it is not useful if EPA's presentation of the data leaves
a misleading impression about environmental performance or environmental
conditions in the public mind.
"Resolution of complaints of this nature is likely to be one of the most
important applications of the Guidelines at EPA," the coalition said.
Validation of Lab Tests Urged
James Christman, an attorney with Hunton & Williams, submitted comments on
behalf of the Inter-Industry Analytical Group, which represents automobile
manufacturers, the American Forest and Paper Association, and other
organizations.
The group urged EPA in its final guidelines to "require that data have been
generated by a test method that has been validated using an interlaboratory
study."
"EPA's guidelines will need to ensure that the Agency's test results can be
reproduced by others," the group wrote. It alleged that, as part of the Total
Maximum Daily Load effort, EPA has been using a test method for methylmercury
that has not been validated by multiple laboratories.
Validating test methods can take years and cost a lot of money.
The group said the decisions EPA has begun making have substantial economic
consequences.
Gridlock Feared
In contrast to most industry comments, advocacy groups supported EPA's proposal.
These groups urged EPA to limit the scope of the guidelines to protect itself
from gridlock in dealing with data-quality challenges that, they said, would be
attempts to gut the agency's efforts to protect the environment and public
health.
"In the end," NRDC said, "overzealous implementation will signal the death knell
of this hastily crafted [Data Quality Act], as the agencies, their
constituencies, and the courts recoil at the nightmare that is created."
"The simple fact that EPA engages in activities that upset powerful industries
should not make it a poster child for continual scrutiny and interference with
respect to its implementation of the Data Quality Act," NRDC said.
NRDC said the act is a double-edged sword. Just as industry wants access to EPA
data, advocates will want "secret" industry data disclosed.
Exemption of TRI Data Urged
Actions NRDC urged EPA to take included making sure certain databases, such as
the Toxics Release Inventory, that present information outside parties have
provided to EPA are exempt from the quality guidelines.
"NRDC strongly recommends that the Agency exclude TRI from the coverage of the
act, lest the Agency sink without a trace in a morass of complaints about the
quality of data provided directly by industry." Self-serving firms might assert
that information from other companies is inaccurate or incomplete as an effort
to get the information off the Web, NRDC said.
The agency should establish deadlines by which individuals or organizations must
file correction requests, such as six months after information was disseminated.
The agency also should establish a procedure to allow the public to comment on
data correction requests, NRDC said.
NRDC's key message to EPA was that it should not allow its data-quality efforts
to limit its core mission to protect public health and the environment.
Details on OMB's directive, EPA's proposal, and public comments can be found at
http://www.epa.gov/oei/qualityguidelines on the World Wide Web.
By Pat Phibbs