[Congressional Record Volume 141, Number 39 (Thursday, March 2, 1995)]
[Senate]
[Pages S3428-S3431]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
AMENDMENTS SUBMITTED
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THE DEPARTMENT OF ENERGY RISK MANAGEMENT ACT
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LOTT AMENDMENT NO. 316
(Ordered referred to the Committee on Energy and Natural Resources.)
Mr. LOTT submitted an amendment intended to be proposed by him to the
bill (S. 333) to direct the Secretary of Energy to institute certain
procedures in the performance of risk assessments
[[Page S3429]] in connection with environmental restoration activities,
and for other purposes; as follows:
At the end of the bill add the following:
SEC. 8. JUDICIAL REVIEW.
Any decision, regulatory analysis, risk assessment, hazard
identification, risk characterization, or certification
provided for under this Act is subject to judicial review in
the same manner and at the same time as the underlying final
action to which it pertains, in accordance with chapter 7 of
title 5, United States Code. All data, estimates,
information, reports, studies, explanations, and similar
materials upon which any decision, regulatory analysis, risk
assessment, hazard identification, risk characterization,
certification, or peer review is based shall be made part of
the administrative record for purposes of judicial review.
Sec. 12. Peer Review.
(1) PEER REVIEW BY INDEPENDENT EXTERNAL PEER REVIEW PANELS.
a. Initiation of Peer Review.--The head of the Office of
information and regulatory Affairs of the Office of
management and Budget may initiate a peer review under this
section if he or she determines that such peer review is
advisable because the assessments or analyses to be reviewed
are matters of major importance due to their potential for
direct or indirect health, safety, or environmental or
economic impacts or because they would establish an important
precedent.
b. Establishment and Membership of Panels.--Peer reviews
shall be conducted by panels consisting of members appointed
by the head of the agency which conducted the risk assessment
and cost-benefit analysis, in consultation with the head of
the Office of Information and Regulatory Affairs of the
Office of management and Budget, the head of the Office of
Science and Technology Policy, and other concerned Federal
agencies, and officials of any affected state and local
governments. Separate panels shall be established to review
the benefits portion of the cost-benefit analysis; the cost-
benefit review panel shall review the benefits portion of the
cost-benefit analysis in consultation with the risk
assessment review panel. Peer review panels shall be
established within 90 days after a determination under
subsection (a). Members of the panels shall--
1. be recognized and credentialed experts in the
appropriate disciplines;
2. have recent professional experience conducting a risk
assessment, an assessment of the cost of a regulation, or an
assessment of the benefits of a regulation, as applicable to
the panel for which they are selected;
3. have filed and made publicly available financial
disclosure forms; and
4. have not been involved in a recent comprehensive
analysis of the substance, condition, or activity under
review, and have not recently taken a public position on the
risks or costs to be reviewed.
c. Termination.--A peer review panel shall terminate upon
submission of the report with respect to the risk assessment
or cost-benefit analysis for which the panel was established.
d. Standards Applicable to Peer Review.--
1. all peer reviews of the risk assessments conducted
pursuant to this section shall have the purpose of
determining whether the agency's risk assessment complies
with the principles set out in this Act;
2. all peer reviews of cost-benefit analyses conducted
pursuant to this section shall have the purpose of
determining whether the cost-benefit analysis meets the
standards set out in this Act.
e. Completion Prior to Judicial Review.--If the head of the
Office of information and Regulatory Affairs has initiated
the peer review process pursuant to subsection a, or states
in writing that initiation of the process is under
consideration by that office, no suit for judicial review of
a risk assessment or cost-benefits analysis or related agency
action may be brought until after the peer review process has
concluded or such official determines not to initiate the
process; provided, however, that if such official does not
indicate a determination within 30 days after stating that
such matter is under consideration, a judicial review suit
may be brought and the official will not thereafter have the
authority to issue a determination to initiate the process.
(2) Procedures for Peer Review.
a. Submission to Panel.--Within 30 days after the
establishment of a peer review panel, the head of the Federal
agency shall submit to the panel all data and testing
(including the details of the methodology) used by the agency
for the assessment and analysis.
b. Report and Recommendations.--
1. In general.--Within 180 days after the date on which the
head of the Federal agency submits data and testing under
subsection a, each peer review panel shall transmit to the
head of the agency a report and recommendations on whether
the agency's risk assessment or cost-benefit analysis meets
the applicable standards and principles specified in this
Act.
2. Contents.--A report and recommendations under this
subsection shall either conclude that the agency's assessment
or analysis meets the applicable standards, or shall set out
its views on any significant deficiencies and its
recommendations on how those deficiencies should be
corrected.
3. Comments and appendix.--Each peer review report and
recommendations under this subsection shall include--
(A) all conclusions and recommendations supported by a
majority of the members of the peer review panel submitting
the report; and
(B) an appendix which sets forth the dissenting opinions
that any peer review panel member wants to express.
c. Openness of Process.--The proceedings of peer review
panels under this section shall be subject to the relevant
provisions of the Federal Advisory Committee Act 5 USC App.
(1988), PL 92-463.
(3) Consideration and Incorporation of Peer Review
Recommendations.
If a majority of a peer review panel established under this
subtitle concludes that a risk assessment or cost-benefit
analysis does not meet the applicable standards, the
assessment, analysis or proposed major rule shall not be
issued in final form unless the head of the agency either
revises the risk assessment to include the findings and
recommendations of the peer review panel and makes the
recommended revisions or explains clearly the scientific
basis for disagreeing with any of the panel's recommendations
and not revising the assessment.
(4) Matters Requiring Peer Review.--At a minimum, there
shall be submitted for peer review--
a. all major rules
b. all entries in the Integrated Risk Information System
(IRIS), and the Toxic Release Inventory.
c. any risk assessment which has been used as a scientific
rationale for regulatory actions by local or state
governments.
SEC. 13. ADDITIONAL DEFINITION.
In this Act:
(11) Scientifically Objective and Unbiased.--The term
``scientifically objective and unbiased'' means that the risk
assessment, risk characterization or communication have not
been significantly influenced by policy or value judgments or
preferences, and that it clearly and accurately relates its
descriptions and conclusions regarding risk (or absence of
risk) to data or knowledge, including negative data, that are
based on empirical observations, measurements, or testing
that meet generally accepted scientific standards, and are
substantially reproducible by similarly experienced
scientists analyzing the same data independently.
SEC. 14. TOXIC RELEASE INVENTORY (TRI).
(1) Notwithstanding any other provision of Chapter 116, of
Title 42, United States Code, the Administrator,
Environmental Protection Agency may by rule add a chemical to
the list described in Section 11023(c) only after the
Administrator makes a risk assessment determination that the
chemical causes significant adverse human health effects at
concentration levels that are reasonably likely to exist
beyond the facility site boundaries, the probability of
exposure and potential harm to local residents.
(2) a. In making the risk assessment determination, the
Administrator shall take into account the nature and
frequency of the releases, the actual concentration, and the
frequency of use of the chemical in general commerce.
b. The principles for risk assessment within this act
should be applied to future listings on the Toxic Release
Inventory.
(3) A chemical shall be deleted if the Administrator
determines no later than 60 days after the enactment of this
provision that based on the record there is insufficient
evidence to establish the criteria described in this section.
(4) A chemical shall be deleted if the Administration,
within 180 days of receipt of a petition described in Section
5, does not prepare a risk assessment as described in Section
5 which determines that the chemical causes significant
adverse human health effects at concentration levels that are
reasonably likely to exist beyond the facility site
boundaries, the probability of exposure and potential harm to
local residents.
SEC. 15. USE OF APPROVED RISK ASSESSMENTS.
The Administrator, Environmental Protection Agency shall
not conduct or perform, or require any person to conduct or
perform, as a condition for issuance of any permit, license,
or any other form of approval (or condition to operate), any
type of risk assessment that is not explicitly required as a
condition for the issuance of such a permit, license, or
approval by existing statutory or final regulatory
provisions. The Administrator, Environmental Protection
Agency shall not implement or enforce such a condition in any
way nor deny or condition a permit, license, or approval
based upon the results of such a risk assessment or the
failure to conduct or perform such a risk assessment.
SEC. 16. ``SEC 627. OF AMENDMENT 230--REGULATIONS; PLANS FOR
ASSESSING NEW INFORMATION.''
Change paragraph (b)(1) to read:
Review of the risk assessment, risk characterization, or
risk communication for any major rule or issuance used by
states or local governments as a scientific basis for
regulatory action promulgated or prepared prior to enactment
or prior to issuance of a final regulatory requirement by
subsection (a) of this section shall be conducted by the head
of the agency on the written petition of a person showing a
reasonable likelihood that--
(A) the risk assessment is inconsistent with the principles
set forth in section 625 and 626;
[[Page S3430]] (B) the risk assessment produces
substantially different results;
(C) the risk assessment is inconsistent with a rule issued
under subsection (a);
(D) the risk assessment does not take into account material
significant new scientific data or scientific understanding.
Mr. LOTT. Mr. President, I rise today to speak for the purpose of
submitting an amendment to the Department of Energy Risk Management Act
which was referred to the Senate Committee on the Energy and Natural
Resources for consideration.
Mr. President, I send to the desk an amendment to the Department of
Energy Risk Management Act (S. 333), and ask unanimous consent that it
be printed in the Record.
First, let me say this is the year and this is the Congress that will
establish a genuine link between real risks, as defined by sound
science, and responsible public policy to address risk.
This will be done by including scientific data and an openness in the
regulatory process. My solution is based on citizen involvement. So why
do we hear all of these distortions and exaggerations reporting that
America's health and safety will be placed in jeopardy and sacrificed.
These emotional and often irrational overstatements are just not true.
What is so threatening about requiring knowledgeable scientists, who
are independent of the Government, to participate in a peer review of
the science? It makes sense to me to ensure that science-based rules
are supported by scientist. But clearly, opponents of this provision
believe that scientists are the problem. I find this curious. Peer
review will certify the Government's practices. It replaces an
unchecked monopoly over risk assessment methodologies with
participation of scientists from academia.
What is so threatening about requiring the science to be unbiased and
objective? I guess opponents of this legislation really want rules to
have a bias which supports their political agenda. Accurate science
must get in their way. How distressing. I said it last month on the
Senate floor when S. 333 was introduced, but it is important to repeat
the thought. Maybe those who like the flawed status quo really can be
characterized as backing regulations which indeed are cavalier and
arbitrary.
What is so threatening about requiring products listed on the Toxic
Release Inventory [TRI] to actually be dangerous or, for that matter,
even toxic? Presently, chemicals are listed simply because they appear
frequently in the environment. In fact, many chemicals on the list are
not toxic. EPA knows they are not. EPA has let the TRI misrepresent the
toxicity of chemicals and permitted unnecessary anxiety within local
communities. This is terrible public policy. Also, what is the problem
in requiring a Federal agency to act promptly? To list or delist needs
a fixed public schedule. Maybe it is too much to ask an agency to be
responsive to American citizens.
What is so threatening about judicial review? Opponents complain that
risk assessments would not be constructed by the courts. OK. That is
better than what America has now. Currently, risks are set by arrogant
bureaucrats who are invisible and not accountable to the public. At
least in a court room risk decisions will be made in a public forum.
The American people hold their courts in high esteem, and perhaps
public participation is necessary to save risk assessment.
What is so threatening about emphasizing the need of State and
municipal participation in setting priorities for addressing their
health and safety risks? Providing a structured methodology for making
difficult budgetary choices regarding health and safety matters would
be helpful. Both the officials and the citizens can understand the
risks they face together. And jointly they will be involved in
selecting the risks to address. Cost benefit provisions will be a
useful rational for public policy goal setting and in allocating
funding.
What is so threatening about preventing abuse through indirect risk
assessments? In the words of EPA's own Science Advisory Board, indirect
risk
assessment suffers from a general lack of measured input and very
little validation of the models. By requiring that only approved risk
assessments, we are saying that Federal agencies will only use
assessments subjected to the rigors of this legislation. In fact, EPA
has no legal basis to proceed with indirect risk assessments. Does it
make scientific sense to let EPA hold permits and licenses hostage
without the marketplace having its due process? Does it make sense for
EPA to first demand and then use data which is short on scientific
validation? Both are legally and scientifically reprehensible. We are a
land governed by laws--not by bureaucrats who are not accountable to
the public. Besides, Federal agencies must not regulate by press
release.
The cost-benefit provisions of this legislation are important to
evaluate regulatory effectiveness. This is especially useful since
public funds are scare and finite. And, because governmental intrusion
into our private lives must be minimized to only genuine risk. But the
sad truth is the Government's decisions and actions are rarely cost
effective. In fact, I recently read an article where an EPA official
said that regulatory ``efficiency is not of great importance.'' For
him, his colleagues and this administration it may not be; but to
millions of American taxpayers who pay the bills it is a big deal.
The importance of risk assessment and risk communication with public
participation can not be underscored. This is especially true when we
consider that billions and billions of taxpayer dollars are spent
annually by all levels of government to deal with risk.
I believe the public has lost confidence in the Government's science.
I further believe this has hurt the credibility of existing
environmental and health rules. Saving an owl which is endangered in
two States by destroying 30,000 jobs; only to discover this bird is
thriving in a number of other States is not good science--it is an
agenda. Ruining an entire apple harvest with a rush to judge without
science on alar is not good science--it is regulatory abuse. Both
illustrate a Government unchecked. That is what this legislation is
about--provide an opportunity to challenge the Government.
Nothing in this amendment or the basic bill is excessively
prescriptive. On the contrary, my legislative purpose is to ensure
consistency and technical value
when risk assessments are prepared. I firmly believe my legislative
efforts will improve both the quality and visibility of risk
assessment.
It is time to deal with scientific controversies surrounding the
extrapolations of maximum tolerated dose to minuscule doses, animal to
human etc. Many of the Government's regulatory actions will not stand
up to public scrutiny--this is not the fault of this legislation. No,
this is an error caused by Government's arrogant false science. I am
for environmental, health and safety rules which address real problems,
not regulatory abuse supporting a nonscientific agenda.
Risk assessment is a powerful tool which has been abused for years by
a political agenda. No--it has been exploited. Both public confidence
and public funds have been squandered chasing nonscientific solutions
and nonrisks. Now is the time to transform our environmental and health
policies with accountable scientific judgment.
Risk assessment reforms will help settle environmental and health
decisions with science and technology, not with a political agenda. It
will not eliminate controversies but it will open up the process to
public participation. It will not end environmental laws, as we now
know them. What it will do is make sure that the right information is
on the table in the right form and at the right times to best
incorporate both economic and ecological consequences in the decision
making process.
My approach, through the basic bill (S.333) and with this amendment,
is to demand rigorous, consistent and continuous inclusion of the
public in the development of health and safety public policy. Using a
deliberative and transparent process has merits which exceed all the
complaints I have heard from opponents who say it would create burdens.
My approach will strengthen our public policies, not destroy them.
All I am mandating is sound science. I am not mandating bureaucratic
burdens. If sound science principles are followed there will be no
hassles or problems.
[[Page S3431]] However, I am not terribly sympathetic for a Federal
agency which misbehaved and manipulated the public trust. They have
placed burdens and expenses on Americans through false risks and
unnecessary anxiety. This type of regulatory zeal must be stopped.
Plain and simple; this legislation will identify the underlying
scientific assumptions used in the risk assessments so that all
concerned parties can evaluate the judgments and conclusions. This
process allows for full and open public debate which will neither
threaten our democracy nor the health and safety of the American public
who we all serve.
Opponents want to dismiss any risk assessment legislation as a form
of technospeak to justify the destruction of the environment and health
rules. But this ``sky-is-falling'' complaint strategy is spurious and
disingenuous. This legislation will not remove one environmental or
safety rule. It will, however, require the assumptions, methodologies
and extrapolations to be part of the public record. Only if science
supports different conclusions can the foundation for the rules be
challenged.
I urge my colleagues to look at S.333, the basic legislation which
was introduced by Senators Murkowski and Johnston last month and this
amendment. Both focus on removing risk misinformation and restoring
public confidence in our rulemaking process. I believe it deserves your
support.
It is time to get past partisan bickering and exaggerations.
It is time to end the false debate on the value of risk assessment
and cost benefit analysis.
It is time to focus our health and safety policies with sound risk
assessment methodologies.
It is time for Congress to act.
I thank my colleagues for their consideration.
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