[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 333 Introduced in Senate (IS)]







104th CONGRESS
  1st Session
                                 S. 333

 To direct the Secretary of Energy to institute certain procedures in 
 the performance of risk assessments in connection with environmental 
            restoration activities, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

             February 2 (legislative day, January 30), 1995

Mr. Murkowski (for himself, Mr. Johnston, and Mr. Lott) introduced the 
 following bill; which was read twice and referred to the Committee on 
                      Energy and Natural Resources

_______________________________________________________________________

                                 A BILL


 
 To direct the Secretary of Energy to institute certain procedures in 
 the performance of risk assessments in connection with environmental 
            restoration activities, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION. 1. SHORT TITLE.

    This Act may be cited as the ``Department of Energy Risk Management 
Act of 1995.''

 SEC. 2. TABLE OF CONTENTS.

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Definitions.
Sec. 4. Applicability; principles for risk assessment, characterization 
                            and communication.
Sec. 5. Regulation; plan for assessing new information.
Sec. 6. Requirements for environmental restoration activity.
Sec. 7. Environmental restoration priorities.
Sec. 8. Judicial review.
Sec. 9. Savings provisions.

 SEC. 3. DEFINITIONS.

    In this Act:
            (1) Best estimate.--The term ``best estimate'' means an 
        estimate that, to the extent feasible and scientifically 
        appropriate, provides the most unbiased representation of the 
        most plausible level of risk, given the most reliable current 
        scientific information available to the Department.
            (2) Costs.--The term ``costs'' includes the direct and 
        indirect costs to the United States Government, to State and 
        local governments, and to the private sector, of implementing 
        and complying with a regulatory action.
            (3) Department.--The term ``Department'' means the 
        Department of Energy.
            (4) Environmental restoration activity.--The term 
        ``environmental restoration activity'' means a removal or 
        remedial action conducted by the Department at nuclear 
        facilities under the control of the Department, including the 
        Savannah River Site, Hanford Nuclear Reservation, Nevada Test 
        Site, Rocky Flats Plant, Idaho National Engineering Laboratory, 
        Los Alamos National Laboratory, Lawrence Livermore National 
        Laboratory, and any other such facility.
            (5) Hazard.--The term ``hazard'' means a substance, 
        activity, or condition which potentially poses a risk to human 
        health or safety or the environment based on empirical data, 
        measurements, or testing showing that it has caused significant 
        adverse effects at some levels of dose or exposure not 
        necessarily relevant to level of dose or exposure that are 
        normally expected to occur.
            (6) Plausible.--The term ``plausible'' means realistic and 
        scientifically probable.
            (7) Risk assessment.--The term ``risk assessment'' means--
                    (A) the process of identifying hazards and 
                quantifying or describing the degree of toxicity, 
                exposure, or other risk they pose for demonstrably 
                exposed individuals, populations, or resources; or
                    (B) the document containing the explanation of how 
                the risk assessment process has been applied to an 
                individual substance, activity, or condition.
            (8) Risk characterization.--The term ``risk 
        characterization''--
                    (A) means the element of a risk assessment that 
                involves presentation of the degree of risk set forth 
                in any plan, assessment, or record of decision, report 
                to Congress, or other document that is made available 
                to the public; and
                    (B) includes discussions of uncertainties, 
                conflicting data, estimates, extrapolations, 
                inferences, justifications, and opinions.
            (9) Secretary.--The term ``Secretary'' means the Secretary 
        of Energy, or the Secretary's designee.
            (10) Substitution risk.--The term ``substitution risk'' 
        means a potential increased risk to human health, safety, or 
        the environment from a regulatory option designed to decrease 
        other risks.

 SEC. 4. APPLICABILITY; PRINCIPLES FOR RISK ASSESSMENT, RISK 
              CHARACTERIZATION, AND COMMUNICATION.

    (a) Applicability.--
            (1) In general.--Except as provided in paragraph (2), this 
        Act applies to all risk assessments and risk characterizations 
        prepared by, or on behalf of, the Department as part of an 
        environmental restoration activity.
            (2) Exceptions.--
                    (A) Emergencies and screening analyses.--This Act 
                does not apply to risk assessments or risk 
                characterizations performed with respect to either of 
                the following:
                            (i) A situation that the Secretary 
                        determines to be an emergency.
                            (ii) A screening analysis, including a 
                        screening analysis for purposes of product 
                        regulation, product reregistration, or 
                        premanufacturing notices.
                    (B) Treatment of analysis as screening analysis.--
                No analysis shall be treated as a screening analysis 
                for purposes of subparagraph (A) if the results of the 
                analysis is used--
                    (i) as the basis for imposing restrictions on 
                substances or activities; or
                    (ii) to characterize a positive finding of risks 
                from substances or activities in any Departmental 
                document made available to the general public.
    (b) Principles for Risk Assessment.--
            (1) In general.--The Secretary shall apply the principles 
        set forth in paragraph (2) when preparing a risk assessment in 
        order to ensure that the risk assessment distinguishes 
        scientific findings from other considerations and are, to the 
        maximum extent feasible, scientifically objective, unbiased, 
        and inclusive of all relevant data. Discussions or explanations 
        required under this section need not be repeated in each risk 
        assessment document as long as there is a reference to the 
        relevant discussion or explanation in another agency document.
            (2) Principles.--The principles to be applied when 
        preparing risk assessments are as follows:
                    (A) Human health risks.--When assessing human 
                health risks in connection with a risk assessment, the 
                Secretary shall consider and discuss both laboratory 
                and epidemiological data of sufficient quality that 
                finds, or fails to find, a correlation between health 
                risks and a potential toxin or activity. When conflicts 
                among the data appear to exist or when animal data are 
                used as a basis to assess human health, the assessment 
                shall include discussion of possible reconciliation of 
                conflicting data.
                    (B) Significant assumptions.--When a risk 
                assessment involves selection of any significant 
                assumption, inference, or model, the Secretary shall--
                            (i) describe the plausible alternative 
                        assumptions, inferences, or models;
                            (ii) explain the basis for any choices 
                        among the assumptions, inferences, or models;
                            (iii) identify any policy or value 
                        judgments involved in choosing from among the 
                        alternative assumptions, inferences, or models;
                            (iv) fully describe any model used in the 
                        risk assessment and make explicit the 
                        assumptions incorporated in the model; and
                            (v) indicate the extent to which any 
                        significant model has been validated by, or 
                        conflicts with, empirical data.
    (c) Principles for Risk Characterization and Communication.--When 
characterizing risk, the Secretary shall comply with each of the 
following:
            (1) Estimates of risk.--
                    (A) Best estimate.--The Secretary shall describe 
                the populations or natural resources that are the 
                subject of the risk characterization. If a numerical 
                estimate of risk is provided, the Secretary shall, to 
                the extent feasible and scientifically appropriate, 
                provide--
                            (i) the best estimate for the specific 
                        populations or natural resources that are the 
                        subject of the characterization (based on the 
                        information available to the Department); and
                            (ii) a statement of the reasonable range of 
                        scientific uncertainties.
                    (B) Multiple best estimates.--In appropriate 
                circumstances the Secretary may present, in lieu of a 
                single best estimate, multiple estimates based on 
                assumptions, inferences, or models that are equally 
                plausible, given current scientific understanding.
                    (C) Plausible upper-bound or conservative 
                estimates.--In addition to a best estimate or 
                estimates, the Secretary may present plausible upper-
                bound or conservative estimates in conjunction with 
                plausible lower bounds estimates.
                    (D) Descriptions of distribution and probability.--
                To the extent practicable and appropriate, the 
                Secretary shall provide descriptions of the 
                distribution and probability of risk estimates to 
                reflect differences in exposure variability in 
                populations and uncertainties.
            (2) Exposure scenarios.--The Secretary shall explain the 
        exposure scenarios used in any risk assessment, and, to the 
        extent feasible, provide a statement of the size of the 
        corresponding population at risk and the likelihood of the 
        exposure scenarios.
            (3) Comparisons.--To the extent feasible, the Secretary 
        shall provide a statement that places the nature and magnitude 
        of risks to human health in context. The statement shall 
        include appropriate comparisons with estimates of risks that 
        are familiar to and routinely encountered by the general public 
        as well as other risks.
            (4) Substitution risks.--When the Secretary provides a risk 
        assessment or risk characterization for an environmental 
        restoration activity, the assessment or characterization shall 
        include a statement of any significant substitution risks to 
        human health, where information on such risks has been provided 
        to the Secretary.

 SEC. 5. REGULATION; PLAN FOR ASSESSING NEW INFORMATION.

    (a) Regulation.--Within 1 year after the date of enactment of this 
Act, the Secretary shall issue a final regulation implementing for the 
Department the risk assessment and risk characterization principles set 
forth in this Act. The final regulation shall establish a format for 
summarizing risk assessment results.
    (b) Plan.--
            (1) In general.--Within 1 year after the date of enactment 
        of this Act, the Secretary shall promulgate a plan to review 
        and revise any risk assessment prepared by or on behalf of the 
        Secretary and completed prior to the promulgation of the plan, 
        if the Secretary determines that significant new information or 
        methodologies are available that could significantly alter the 
        results of the prior risk assessment or that there are other 
        appropriate reasons why such a review and revision should be 
        conducted.
            (2) Contents.--A plan promulgated under (1) shall--
                    (A) provide procedures for receiving and 
                considering new information and risk assessments from 
                the public;
                    (B) set priorities for review and revision of risk 
                assessments based on such factors as the Secretary 
                considers appropriate; and
                    (C) include a process by which members of the 
                public may petition the Secretary for review of 
                particular assessments.
            (3) Response to petition.--Not later than 60 days after 
        receiving a petition under paragraph (2)(C), the Secretary 
        shall respond to the petition by agreeing or declining to 
        review the risk assessment referred to in the petition, and 
        shall state the basis for the decision.
            (4) Completion of review.--If the Secretary agrees to 
        review a risk assessment, the Department shall complete its 
        review within 180 days, unless the Secretary agrees in writing 
        that an extension not to exceed 60 days is necessary in view of 
        limitations on Department resources.
    (c) Public Comment and Consultation.--The regulation and plan, 
under this sections shall be developed after notice and opportunity for 
public comment.
    (d) Review.--At least every 4 years, the Secretary shall review, 
and when appropriate, revise the regulation and plan published under 
this section.

 SEC. 6. REQUIREMENTS FOR ENVIRONMENTAL RESTORATION ACTIVITY.

    (a) In General.--Any plan, assessment, or record of decision to 
conduct an environmental restoration activity shall include a clear and 
concise statement that--
            (1) describes and, to the extent practicable, quantifies 
        the risks to human health, safety, and the environment to be 
        addressed by the environmental restoration activity;
            (2) compares the human health or environmental risks to be 
        addressed by the environmental restoration activity to other 
        risks chosen by the Secretary, including--
                    (A) at least 3 other risks regulated by the 
                Department or another Federal agency; and
                    (B) at least 3 other risks that are familiar to the 
                general public;
            (3) describes and, to the extent practicable, quantifies 
        any known, plausible substitution risks when information on 
        such risks has been provided to the Department;
            (4) estimates--
                    (A) the costs to the United States Government of 
                conducting the environmental restoration activity; and
                    (B) the benefits of the environmental restoration 
                activity, including both quantifiable measures of costs 
                and benefits, to the fullest extent that they can be 
                estimated, and qualitative measures that are difficult 
                to quantify; and
            (5) contains a certification by the Secretary that--
                    (A) the analyses performed under paragraphs (1), 
                (2), and (3) are, to the maximum extent practicable--
                            (i) based on the best reasonably obtainable 
                        scientific and economic information; and
                            (ii) objective and unbiased;
                    (B) the environmental restoration activity is 
                likely to significantly reduce the human health, 
                safety, or environmental risks to be addressed;
                    (C) no environmental restoration activity 
                alternative that would achieve an equivalent reduction 
                in risk in a more cost-effective manner is permitted 
                under the Comprehensive Environmental Response, 
                Compensation, and Liability Act of 1980 (42 U.S.C. 9601 
                et seq.); and
                    (D) the environmental restoration activity is 
                likely to produce benefits to human health or the 
                environment that will justify the costs to the United 
                States Government.
    (b) Reporting.--If the Secretary cannot make a certification with 
respect to 1 or more of the matters described in subsection (a), the 
Secretary shall identify the matters for which certification cannot be 
made, and shall include a statement of the reasons why the 
certification cannot be made in the plan, assessment, or record of 
decision. Not later than March 1 of each year, the Secretary shall 
submit a report to Congress identifying the environmental restoration 
activities conducted during the previous calendar year for which 
complete certification was not made, and summarizing the reasons 
therefore.

 SEC. 7. ENVIRONMENTAL RESTORATION PRIORITIES.

    (a) Setting of Priorities.--The Secretary shall prioritize the use 
of the resources available to conduct restoration activities to address 
the risks to human health, safety and the environment that--
            (1) the Secretary determines are the most serious; and
            (2) can be addressed in a cost-effective manner, with the 
        goal of achieving the greatest overall net reduction in risks 
        with the public and private sector resources to be expended.
    (b) Determining Most Serious Risks.--In identifying the sources of 
the most serious risks under subsection (a), the Secretary shall 
consider, at a minimum--
            (1) the plausible likelihood and severity of the effect; 
        and
            (2) the plausible number and groups of individuals 
        potentially affected.
    (c) Incorporation of Risk-Based Priorities Into Budget and 
Planning.--The Secretary shall incorporate the priorities identified in 
subsection (a) into the Department's budget, strategic planning, and 
research activities by--
            (1) in the Department's annual budget request to Congress--
                    (A) identifying which risks that the Secretary has 
                determined are the most serious and can be addressed in 
                a cost-effective manner under subsection (a), and the 
                basis for that determination;
                    (B) explicitly identifying how the Department's 
                requested funds will be used to address those risks; 
                and
                    (C) identifying any statutory, regulatory, or 
                administrative obstacles to allocating Departmental 
                resources in accordance with the priorities established 
                under subsection (a); and
                    (D) explicitly considering the requirements of 
                subsection (a) when preparing the Department's 
                environmental management plan or other strategic plan 
                and providing an explanation of how the agenda or plan 
                reflects those requirements and the comparative risk 
                analysis when publishing any such agenda or strategic 
                plan.
    (e) Recommendation.--In March of each year, the Secretary shall 
submit to Congress specific recommendations for repealing or modifying 
laws that would better enable the Department to prioritize its 
activities to address the risks to human health, safety, and the 
environment that are the most serious and can be addressed in a cost-
effective manner consistent with the requirements of subsection (a).

SEC. 9. SAVINGS PROVISIONS.

    Nothing in this Act shall be construed to--
            (1) modify any statutory standard or requirement designed 
        to protect health, safety, or the environment;
            (2) preclude the consideration of any data or the 
        calculation of any estimate to more fully describe risk or 
        provide examples of scientific uncertainty or variability; or
            (3) require the disclosure of any trade secret or other 
        proprietary information.
                                 <all>
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