[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

                                 ______


              THE DEPARTMENT OF ENERGY RISK MANAGEMENT ACT

                                 ______


                         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.
  

                          ____________________