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





                                                       Calendar No. 116

104th CONGRESS

  1st Session

                                 S. 333

                          [Report No. 104-87]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                 May 25 (legislative day, May 15), 1995

                       Reported with an amendment





                                                       Calendar No. 116
104th CONGRESS
  1st Session
                                 S. 333

                          [Report No. 104-87]

 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

                 May 25 (legislative day, May 15), 1995

              Reported by Mr. Murkowski, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,
<DELETED>SECTION. 1. SHORT TITLE.</DELETED>

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

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

<DELETED>    In this Act:</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (3) Department.--The term ``Department'' means the 
        Department of Energy.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (6) Plausible.--The term ``plausible'' means 
        realistic and scientifically probable.</DELETED>
        <DELETED>    (7) Risk assessment.--The term ``risk assessment'' 
        means--</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (B) the document containing the 
                explanation of how the risk assessment process has been 
                applied to an individual substance, activity, or 
                condition.</DELETED>
        <DELETED>    (8) Risk characterization.--The term ``risk 
        characterization''--</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (B) includes discussions of uncertainties, 
                conflicting data, estimates, extrapolations, 
                inferences, justifications, and opinions.</DELETED>
        <DELETED>    (9) Secretary.--The term ``Secretary'' means the 
        Secretary of Energy, or the Secretary's designee.</DELETED>
        <DELETED>    (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.</DELETED>

<DELETED> SEC. 4. APPLICABILITY; PRINCIPLES FOR RISK ASSESSMENT, RISK 
              CHARACTERIZATION, AND COMMUNICATION.</DELETED>

<DELETED>    (a) Applicability.--</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (2) Exceptions.--</DELETED>
                <DELETED>    (A) Emergencies and screening analyses.--
                This Act does not apply to risk assessments or risk 
                characterizations performed with respect to either of 
                the following:</DELETED>
                        <DELETED>    (i) A situation that the Secretary 
                        determines to be an emergency.</DELETED>
                        <DELETED>    (ii) A screening analysis, 
                        including a screening analysis for purposes of 
                        product regulation, product reregistration, or 
                        premanufacturing notices.</DELETED>
                <DELETED>    (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--</DELETED>
                <DELETED>    (i) as the basis for imposing restrictions 
                on substances or activities; or</DELETED>
                <DELETED>    (ii) to characterize a positive finding of 
                risks from substances or activities in any Departmental 
                document made available to the general 
                public.</DELETED>
<DELETED>    (b) Principles for Risk Assessment.--</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (2) Principles.--The principles to be applied when 
        preparing risk assessments are as follows:</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (B) Significant assumptions.--When a risk 
                assessment involves selection of any significant 
                assumption, inference, or model, the Secretary shall--
                </DELETED>
                        <DELETED>    (i) describe the plausible 
                        alternative assumptions, inferences, or 
                        models;</DELETED>
                        <DELETED>    (ii) explain the basis for any 
                        choices among the assumptions, inferences, or 
                        models;</DELETED>
                        <DELETED>    (iii) identify any policy or value 
                        judgments involved in choosing from among the 
                        alternative assumptions, inferences, or 
                        models;</DELETED>
                        <DELETED>    (iv) fully describe any model used 
                        in the risk assessment and make explicit the 
                        assumptions incorporated in the model; 
                        and</DELETED>
                        <DELETED>    (v) indicate the extent to which 
                        any significant model has been validated by, or 
                        conflicts with, empirical data.</DELETED>
<DELETED>    (c) Principles for Risk Characterization and 
Communication.--When characterizing risk, the Secretary shall comply 
with each of the following:</DELETED>
        <DELETED>    (1) Estimates of risk.--</DELETED>
                <DELETED>    (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--</DELETED>
                        <DELETED>    (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</DELETED>
                        <DELETED>    (ii) a statement of the reasonable 
                        range of scientific uncertainties.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (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.</DELETED>
                <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED> SEC. 5. REGULATION; PLAN FOR ASSESSING NEW 
              INFORMATION.</DELETED>

<DELETED>    (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.</DELETED>
<DELETED>    (b) Plan.--</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (2) Contents.--A plan promulgated under (1) 
        shall--</DELETED>
                <DELETED>    (A) provide procedures for receiving and 
                considering new information and risk assessments from 
                the public;</DELETED>
                <DELETED>    (B) set priorities for review and revision 
                of risk assessments based on such factors as the 
                Secretary considers appropriate; and</DELETED>
                <DELETED>    (C) include a process by which members of 
                the public may petition the Secretary for review of 
                particular assessments.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (c) Public Comment and Consultation.--The regulation and 
plan, under this sections shall be developed after notice and 
opportunity for public comment.</DELETED>
<DELETED>    (d) Review.--At least every 4 years, the Secretary shall 
review, and when appropriate, revise the regulation and plan published 
under this section.</DELETED>

<DELETED> SEC. 6. REQUIREMENTS FOR ENVIRONMENTAL RESTORATION 
              ACTIVITY.</DELETED>

<DELETED>    (a) In General.--Any plan, assessment, or record of 
decision to conduct an environmental restoration activity shall include 
a clear and concise statement that--</DELETED>
        <DELETED>    (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;</DELETED>
        <DELETED>    (2) compares the human health or environmental 
        risks to be addressed by the environmental restoration activity 
        to other risks chosen by the Secretary, including--</DELETED>
                <DELETED>    (A) at least 3 other risks regulated by 
                the Department or another Federal agency; and</DELETED>
                <DELETED>    (B) at least 3 other risks that are 
                familiar to the general public;</DELETED>
        <DELETED>    (3) describes and, to the extent practicable, 
        quantifies any known, plausible substitution risks when 
        information on such risks has been provided to the 
        Department;</DELETED>
        <DELETED>    (4) estimates--</DELETED>
                <DELETED>    (A) the costs to the United States 
                Government of conducting the environmental restoration 
                activity; and</DELETED>
                <DELETED>    (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</DELETED>
        <DELETED>    (5) contains a certification by the Secretary 
        that--</DELETED>
                <DELETED>    (A) the analyses performed under 
                paragraphs (1), (2), and (3) are, to the maximum extent 
                practicable--</DELETED>
                        <DELETED>    (i) based on the best reasonably 
                        obtainable scientific and economic information; 
                        and</DELETED>
                        <DELETED>    (ii) objective and 
                        unbiased;</DELETED>
                <DELETED>    (B) the environmental restoration activity 
                is likely to significantly reduce the human health, 
                safety, or environmental risks to be 
                addressed;</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED> SEC. 7. ENVIRONMENTAL RESTORATION PRIORITIES.</DELETED>

<DELETED>    (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--
</DELETED>
        <DELETED>    (1) the Secretary determines are the most serious; 
        and</DELETED>
        <DELETED>    (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.</DELETED>
<DELETED>    (b) Determining Most Serious Risks.--In identifying the 
sources of the most serious risks under subsection (a), the Secretary 
shall consider, at a minimum--</DELETED>
        <DELETED>    (1) the plausible likelihood and severity of the 
        effect; and</DELETED>
        <DELETED>    (2) the plausible number and groups of individuals 
        potentially affected.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) in the Department's annual budget request to 
        Congress--</DELETED>
                <DELETED>    (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;</DELETED>
                <DELETED>    (B) explicitly identifying how the 
                Department's requested funds will be used to address 
                those risks; and</DELETED>
                <DELETED>    (C) identifying any statutory, regulatory, 
                or administrative obstacles to allocating Departmental 
                resources in accordance with the priorities established 
                under subsection (a); and</DELETED>
                <DELETED>    (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.</DELETED>
<DELETED>    (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).</DELETED>

<DELETED>SEC. 9. SAVINGS PROVISIONS.</DELETED>

<DELETED>    Nothing in this Act shall be construed to--</DELETED>
        <DELETED>    (1) modify any statutory standard or requirement 
        designed to protect health, safety, or the 
        environment;</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (3) require the disclosure of any trade secret or 
        other proprietary information.</DELETED>
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``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.
Sec. 5. Rule of construction.
Sec. 6. Requirement to prepare risk assessments.
Sec. 7. Requirements for major rules and environmental management 
                            activities.
Sec. 8. Principles for risk assessment.
Sec. 9. Principles for risk communication.
Sec. 10. Review of existing risk assessments.
Sec. 11. Risk assessment and program planning.
Sec. 12. Risk assessment and budgetary priorities.
Sec. 13. Risk assessment improvement programs.
Sec. 14. Judicial review.
SEC. 3. DEFINITIONS.

    In this Act:
            (1) Agency.--The term ``agency'' has the meaning stated in 
        section 551(1) of title 5.
            (2) Benefit.--The term ``benefit'' means the reasonably 
        identifiable benefits and desired effects, including 
        quantifiable and nonquantifiable social, environmental, and 
        economic benefits, that are expected to result directly or 
        indirectly from implementation of, or compliance with, a rule 
        or an alternative to a rule.
            (3) Causation assessment.--The term ``causation 
        assessment'' means a scientific evaluation of the relationship 
        between the degree of exposure to a presumed cause of an 
        adverse effect or condition and the incidence or severity of 
        the adverse effect in question, with particular emphasis on the 
        quantitative relation between the presumed cause and the 
        effect.
            (4) Cost.--The term ``cost'' means the reasonably 
        identifiable costs and adverse effects, including quantifiable 
        and nonquantifiable social, environmental, and economic costs 
        that are expected to result directly or indirectly from 
        implementation of, or compliance with, a rule or an alternative 
        to a rule.
            (5) Emergency.--The term ``emergency'' means an imminent 
        and substantial endangerment to public health, safety, or 
        natural resources.
            (6) Environmental management activity.--The term 
        ``environmental management activity'' means a corrective action 
        under the Solid Waste Disposal Act, the treatment, disposal, or 
        storage of radioactive or mixed waste, or a remedial or removal 
        action under the Comprehensive Environmental Response, 
        Compensation, and Liability Act of 1980, as amended.
            (7) Exposure assessment.--The term ``exposure assessment'' 
        means the scientific determination of the intensity, frequency, 
        and duration of actual or hypothetical exposures to the hazard 
        in question.
            (8) Hazard.--The term ``hazard'' means any activity, 
        substance, or condition which might pose a risk to human 
        health, safety, or the environment.
            (9) Hazard identification.--The term ``hazard 
        identification'' means the scientific determination of whether 
        exposure to a hazard can cause an increased incidence of 
        adverse health or environmental effects that are of sufficient 
        importance to warrant further scientific study or regulatory 
        attention, as well as characterization of the nature and 
        strength of the evidence of causation.
            (10) Major rule.--The term ``major rule''--
                    (A) means a rule or group of closely related rules 
                that the agency proposing the rule or the President 
                reasonably determines is likely to have an effect on 
                the economy of $75,000,000 or more in reasonably 
                quantifiable costs, in any one year; but
                    (B) does not include a rule that involves the 
                internal revenue laws of the United States.
            (11) Major risk communication.--The term ``major risk 
        communication'' means a written or broadcast public 
        communication by an agency, or by another organization under a 
        contract, cooperative agreement, or financial assistance award 
        from an agency, to Congress, State, local or tribal 
        governments, or the general public, which makes a 
        recommendation as to risk that would, if
         implemented, be likely to have an effect on the economy of 
$75,000,000 or more in reasonably quantifiable costs, in any one year.
            (12) Person.--The term ``person'' has the meaning stated in 
        section 551(2) of title 5.
            (13) Plausible.--The term ``plausible'' means realistic and 
        scientifically supported.
            (14) Policy judgment.--The term ``policy judgment'' means 
        any assumptions, inferences, choices of models, or safety 
        factors that are used in a risk assessment because of the 
        absence of relevant available information.
            (15) Risk assessment.--The term ``risk assessment'' means 
        the systematic process of organizing and analyzing scientific 
        knowledge and information for potentially hazardous situations 
        and activities or for substances that might pose risks under 
        specified conditions, taking into account both the intrinsic 
        hazard as well as the exposure to that hazard. As appropriate 
        for the specific risk involved, risk assessment includes hazard 
        identification, causation assessment, exposure assessment, and 
        risk characterization.
            (16) Risk characterization.--The term ``risk 
        characterization'' means the combination of assessments of 
        exposure and response under various exposure conditions to 
        estimate the probability of specific harm to an exposed 
        individual, population, or natural resource including, to the 
        extent feasible, a characterization of the distribution of 
        risk, and including an analysis of uncertainties, conflicting 
        data, and inferences and assumptions in the assessment.
            (17) Rule.--The term ``rule'' has the meaning stated in 
        section 551(4) of title 5.
            (18) Screening analysis.--The term ``screening analysis'' 
        means an analysis using simple, conservative models and 
        assumptions to arrive at an estimate of upper and lower bounds 
        that permits the manager to eliminate risks from further 
        consideration and analysis, or to help establish priorities for 
        agency action.
            (19) Substitution risk.--The term ``substitution risk'' 
        means an increased risk to human health, safety, or the 
        environment likely to result from a regulatory or nonregulatory 
        option designed to decrease other risks.

SEC. 4. APPLICABILITY.

    (a) Except as provided in subsection (b), this Act shall apply to 
all risk assessments prepared by, or on behalf of, an agency in 
connection with health, safety, and environmental risks.
    (b) Exclusions.--The head of an agency shall not be required to 
prepare a risk assessment under this Act for--
            (1) any situation that the head of the agency finds to be 
        an emergency;
            (2) a rule or agency action that authorizes the 
        introduction into commerce, or recognizes the marketable status 
        of a product;
            (3) a health, safety, or environmental inspection or 
        individual facility permitting action;
            (4) product registrations, re-registrations, tolerance 
        settings; and reviews of premanufacturing notices and existing 
        chemicals under the Federal Insecticide, Fungicide, and 
        Rodenticide Act (7 U.S.C. 136 et seq.) and the Toxic Substances 
        Control Act (15 U.S.C. 2601 et seq.);
            (5) any food, drug, or other product label or any risk 
        communication appearing on any such label or product insert; or
            (6) a screening analysis.
    (c) An analysis shall not be treated as a screening analysis for 
the purposes of paragraph (b)(6) if the result of the analysis is 
used--
            (1) as the basis for imposing a restriction on a substance, 
        product, or activity; or
            (2) to characterize a positive finding of risks from a 
        substance or activity in any major risk communication.

SEC. 5. RULE OF CONSTRUCTION.

    (a) Nothing in this Act shall be construed to modify any statutory 
standard or requirement to protect health, safety, or the environment.
    (b) Nothing in this Act shall be construed to preclude the 
consideration of any reliable scientific data or the calculation of any 
estimate to describe more fully risk or to provide examples of 
scientific uncertainty or variability.
    (c) Nothing in this Act shall be construed to require the 
disclosure of any trade secret or other commercial proprietary 
information or any other confidential information.

SEC. 6. REQUIREMENT TO PREPARE RISK ASSESSMENTS.
    (a) Major Rules.--An agency shall prepare a risk assessment under 
this Act for each major rule relating to human health, safety, or the 
environment that is--
            (1) proposed after the date of enactment of this Act; or
            (2) not published as a final rule before the date of 
        enactment of this Act.
    (b) Major Risk Communication.--An agency shall prepare a risk 
assessment under this Act for each major risk communication that is 
released after the date of enactment of this Act.
    (c) Environmental Management Activity.--Except where otherwise 
required by law or regulation, an agency shall prepare a risk 
assessment under this Act prior to conducting an environmental 
management activity to eliminate a risk or reduce it to reasonable 
limits, if the agency head determines that the estimated cost of the 
environmental management activity is more than $25,000,000.

SEC. 7. REQUIREMENTS FOR MAJOR RULES AND ENVIRONMENTAL MANAGEMENT 
              ACTIVITIES.

    (a) In General.--Except as provided in subsection (b), in 
promulgating any proposed or final major rule relating to human health, 
safety, or the environment or in conducting any environmental 
management activity, an agency shall publish in the Federal Register 
along with the rule, or make part of the publicly available record for 
the environmental management activity, 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 major rule or environmental management 
        activity based on the conclusions of a risk assessment 
        performed in accordance with this Act;
            (2) compares the human health, safety, or environmental 
        risks to be addressed by the major rule or environmental 
        management activity to other risks chosen by the agency head, 
        including--
                    (A) at least three other risks regulated by a 
                Federal agency; and
                    (B) at least three 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 is known to or has been provided to the agency;
            (4) estimates--
                    (A) the costs to the United States Government, 
                State, and local governments, and the private sector of 
                complying with or implementing the major rule or 
                carrying out the environmental management activity; and
                    (B) the benefits of the regulation or environmental 
                management 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 agency head that--
                    (A) the analyses performed under paragraphs (1), 
                (2), and (3) are in accordance with the requirements of 
                section 8;
                    (B) the major rule or environmental management 
                activity is likely to reduce significantly the human 
                health, safety, or environmental risks to be addressed;
                    (C) no regulatory alternative, or alternative 
                environmental management activity, that would achieve 
                an equivalent reduction in risk in a more cost-
                effective manner, is permitted under law, along with a 
                brief explanation of why other such alternatives that 
                were considered by the agency head were found to be 
                less cost-effective; and
                    (D) the major rule or environmental management 
                activity, is likely to produce incremental benefits to 
                human health or the environment that will justify the 
                incremental costs to the United States Government, 
                State, local, or tribal governments, and the private 
                sector.
    (b) Substantially Similar Final Major Rules.--If the agency head 
determines that a final major rule is substantially similar to the 
proposed version of the major rule with respect to each of the matters 
referred to in subsection (a), the agency head may publish in the 
Federal Register a reference to the statement published under 
subsection (a) for the proposed rule in lieu of publishing a new 
statement for such final rule.
    (c) Reporting.--If the agency head cannot certify with respect to 
one or more of the matters addressed in subsection (a), the agency head 
shall identify those matters for which certification cannot be made, 
and shall include a statement of the reasons therefore in the Federal 
Register along with the major rule or, in the case of
 an environmental management activity, the publicly available plan. Not 
later than April 1 of each year, the agency head shall submit a report 
to Congress identifying those major rules and environmental management 
activities, promulgated or carried out during the previous calendar 
year, for which complete certification was not made, and summarizing 
the reasons therefor.
    (d) Additional Requirements for Environmental Management 
Activities.--(1) The agency head shall use the risk assessment for an 
environmental management activity to determine the need for the 
environmental management activity and to evaluate environmental 
management alternatives. A risk assessment conducted under this section 
shall be incorporated into any similar statement, assessment, or 
analysis conducted under any other statute for this environmental 
management activity.
    (2) If the agency head cannot make a certification with respect to 
one or more of the matters described in subsection (a)(5) of this 
section, the agency head shall consider--
            (A) funding research and development of new technologies 
        for environmental management; and
            (B) selecting the new technology, if any, achieving the 
        greatest risk reduction and cost efficiencies for use in the 
        environmental management activity.

SEC. 8. PRINCIPLES FOR RISK ASSESSMENT.

    (a) In General.--Except as provided in section 4, the head of an 
agency shall follow the principles set forth in this section when 
preparing risk assessments. Agencies shall not be required to repeat 
discussions or explanations required under this section in each risk 
assessment if there is an unambiguous reference to a relevant 
discussion or explanation in another reasonably available agency 
document that was prepared in accordance with the principles of this 
section.
    (b) Relationship to Risk Management.--An agency shall design and 
conduct risk assessments and report the results in a manner that 
promotes rational and informed risk management decision making and 
informed public input into the process of making agency decisions. In 
undertaking risk assessments, agencies should establish and maintain a 
clear distinction between the identification, quantification, and 
characterization of risks and the selection of methods for managing 
risks. Agency priorities for managing risks, and a consideration of the 
types of information that would be important in evaluating a full range 
of decisions, may play a role in developing priorities for risk 
assessment activities.
    (c) Iterative and Proportionate Approach.--(1) In conducting risk 
assessments, an agency shall--
            (A) employ the level of detail and rigor appropriate and 
        practicable for reasoned decision making on the matter 
        involved, taking into account the significance and complexity 
        of the potential agency action and the need for expedition; and
            (B) develop and use an iterative approach to risk 
        assessment, which may start with relatively inexpensive 
        screening analyses and then progress to more rigorous analyses.
    (2) In determining whether to proceed to more detailed analyses 
that might improve the scientific quality and completeness of the risk 
estimates, the agency head shall take into consideration--
            (A) whether or not the available information has 
        demonstrated that the estimated risk is below the applicable 
        decision-making level;
            (B) whether or not further improvements in scientific data 
        or models would significantly change the risk estimate; and
            (C) whether or not the risk is significant enough to 
        warrant further analysis.
    (3) If an iterative risk assessment process results in the 
availability of more and better scientific information on a specific 
risk, and correspondingly less uncertainty in the analysis, the level 
of conservatism applied to the risk assessment should decrease.
    (d) Use of Policy Judgments in Risk Assessment.--Policy judgments 
used in developing a risk assessment, including assumptions, defaults, 
inferences, choices of models, and safety factors, shall be described 
explicitly in connection with each risk assessment in which they are 
used, along with--
            (1) a description of the scientific and policy basis for 
        each policy judgment;
            (2) a description of any available scientific data, with 
        emphasis on site- or situation-specific data, that was not used 
        because a policy judgment was utilized in its place, the 
        rationale for using the policy judgment, and a description of 
        the sensitivity of the conclusions of the risk assessment to 
        the available data had it been used;
            (3) a description of reasonable alternative policy 
        judgments that were not selected by the agency for use in the 
        risk assessment, and a discussion of why the agency believes 
        that the policy judgments selected for use are appropriate to 
        the specific risk assessment;
            (4) a description of the extent to which policy judgments 
        used in the risk assessment are validated by, or conflict with, 
        empirical data relevant to the assessment; and
            (5) a description of the sensitivity of the conclusions of 
        the risk assessment to the policy judgments used in the risk 
        assessments.
Each agency shall develop a procedure and publish guidelines for 
choosing default policy judgments to use in risk assessments and for 
deciding when and how, in a specific risk assessment, to adopt 
alternative judgments or to use available scientific information in 
place of a policy judgment.
    (e) Consideration of Future Land Use.--In conducting a risk 
assessment for an environmental management activity under this Act, the 
agency head shall consider the reasonably anticipated future use of the 
land affected by the environmental management activity.
    (f) Treatment of Scientific Data in Risk Assessments.--
            (1) The technical basis of a risk assessment shall be--
                    (A) the best available, scientifically replicable 
                data that finds, or fails to find, a correlation 
                between a potential hazard and adverse effects;
                    (B) the best available, scientifically replicable 
                laboratory or experimental data that has relevance to 
                understanding the potential hazard to humans or the 
                environment; and
                    (C) hazard, dose, exposure, or other relevant 
                physical conditions that are reasonably expected to be 
                encountered under usual and realistic circumstances.
        A risk assessment shall not exaggerate risks by inappropriately 
        compounding multiple hypothetical conservative policy 
        judgments.
            (2) When conflicts among scientific data appear to exist, 
        the assessment shall include an explanation for, or possible 
        reconciliation of, conflicting information.
            (3) When animal data are used as a basis to assess human 
        health risks, the assessment shall include a discussion of the 
        relevance of experimental animal responses to human outcomes, 
        the basis for selecting any interspecies scaling factors that 
        were used, and the correspondence among routes of exposure in 
        humans and the exposure routes utilized in the animal studies.
            (4) Any relevant scientific data meeting the requirements 
        of subsection (f)(1) of this section that are submitted by 
        interested parties shall be reviewed and considered in the risk 
        assessment. The risk assessment shall include an explanation of 
        whether such data were used and, if not, why not.
    (g) Public Involvement in Risk Assessments.--Agency heads shall 
provide for early involvement by all interested parties in the 
development of risk assessments. Agency heads shall provide appropriate 
opportunity for
 meaningful public participation and comment on risk assessment 
throughout the regulatory process commensurate with the consequences of 
the decision to be made.
    (h) Peer Review and Scientific Participation in Risk Assessments.--
(1) Each agency shall develop procedures that make the greatest 
possible use of peer review, scientific workshops, expert bodies, or 
other devices to ensure broad peer and scientific participation in its 
risk assessments, through a process that allows full public discussion 
and peer participation by the scientific community.
    (2) Peer review panels shall consist of independent and external 
experts who are broadly representative and balanced to the extent 
feasible.
    (3) A person shall not be excluded from participation in the 
scientific review of a risk assessment on the basis of potential 
interest in the outcome, if the interest is fully disclosed.

SEC. 9. PRINCIPLES FOR RISK COMMUNICATION.

    (a) Description of Risks.--Except as provided in section 4, in any 
major risk communication, regulatory proposal or decision, report to 
Congress, or other document that is intended to communicate the 
conclusions of a risk assessment to the public, the head of the agency 
shall, to the appropriate degree,--
            (1) describe the hazard deemed to be harmful;
            (2) describe the populations or natural resources that are 
        the subject of the risk assessment;
            (3) explain the exposure scenarios used in the risk 
        assessment and provide an estimate of the corresponding 
        population at risk and the likelihood of such exposure 
        scenarios;
            (4) describe the nature and severity of the harm that could 
        plausibly occur; and
            (5) briefly describe the major uncertainties in the hazard 
        identification, causation assessment, and exposure assessment 
        phases of the risk assessment and their influence on the 
        results of the assessment.
    (b) Estimates of Risk.--The estimate of risk shall, to the maximum 
extent practicable, be presented as an overall estimate of risk, 
expressed as a probability distribution that reflects variabilities and 
uncertainties in the analysis. If a single point estimate of risk is 
provided, it must be based on the most plausible inferences from the 
supporting scientific information. Where quantitative estimates of the 
range and distribution of risk estimates are not available, a list of 
qualitative factors influencing the range of possible risks shall be 
provided.
    (c) Comparisons of Risk.--The agency shall provide a statement that 
places the nature and magnitude of risks to human health, safety, and 
the environment being analyzed in context. Such statement shall include 
appropriate comparisons with other risks, including those that are 
familiar to and routinely encountered by the general public.
    (d) Substitution Risks.--When the agency provides a risk assessment 
or risk characterization for a proposed or final regulatory action, 
such assessment or characterization shall include a statement of any 
significant substitution risks to human health or safety, where the 
agency is aware of such information, or it has been provided to the 
agency.
    (e) Summaries of Risk Estimates.--(1) Where an agency provides a 
summary of a risk assessment, the conclusion must include a description 
of the risk that reflects the information required in subsections (a), 
(b), (c), and (d) of this section; and
    (2) if a commenter provides a risk assessment carried out in a 
manner consistent with the principles under section 8 of this Act, and 
a summary of results of such risk assessment, the agency shall present 
such summary in connection with the presentation of the agency's risk 
assessment.
    (f) Review of Major Risk Communications.--The head of an agency 
shall ensure that major risk communications are peer-reviewed by 
appropriate scientific experts and tested with representative groups of 
the public prior to distribution of the major risk communication, to 
ensure that such communications are scientifically accurate and 
communicate the intended risk message without exaggeration.

SEC. 10. REVIEW OF EXISTING RISK ASSESSMENTS.

    (a) Regulation.--Not later than 18 months after the date of 
enactment of this Act, the President shall promulgate a final rule for 
the review and revision of risk assessments previously prepared by, or 
on behalf of, an agency. Such rule shall--
            (1) provide procedures for the agency itself to identify 
        risk assessments that should be reviewed and revised to conform 
        to the principles of risk assessment in this Act or to 
        accommodate new scientific information;
            (2) provide procedures for receiving and considering new 
        information relevant to risk assessments from any person;
            (3) provide a mechanism whereby a person can petition the 
        agency to review and revise a risk assessment because--
                    (A)(i) the risk assessment is inconsistent with the 
                principles set forth in section 8 of this Act; or
                    (ii) the risk assessment does not take into account 
                material and significant new scientific data or 
                scientific understanding; and
                    (B) a revised risk assessment is likely to provide 
                a basis for reevaluating one or more major rules 
                currently in effect or one or more major risk 
                communications;
            (4) provide for the creation of a permanent advisory 
        committee to each agency head that shall--
                    (A) consist of independent and external experts in 
                risk assessment and in the substantive scientific 
                issues related to regulations under the purview of the 
                agency, who are appointed pursuant to the principles of 
                section 8(h);
                    (B) review new information, risk assessments, and 
                petitions from the public regarding review and 
                revisions of risk assessments;
                    (C) recommend to the agency head for each petition 
                under subsection (a)(3)--
                            (i) whether a petition should be granted;
                            (ii) priorities for the review or revision; 
                        and
                            (iii) target dates for completion of the 
                        review or revision; and
                    (D) evaluate the adequacy of the agency's review or 
                revision of a risk assessment, with respect to the 
                principles in section 8 of this Act, and prior to 
                publication of the review or revision, provide 
                recommendations to the agency head.
    (b) Publication of Recommendations.--Recommendations provided to an 
agency head under subsections (a)(4) (C) and (D) shall be published in 
the Federal Register within 45 days of their transmittal to the agency 
head, along with the formal response of the agency head.
    (c) Completion of Agency Action.--(1) If the agency head accepts 
the recommendation of the advisory committee provided under subsection 
(a)(4)(C), the agency shall, to the maximum extent practicable, 
complete its review or revision of the risk assessment within the time 
recommended by the advisory committee.
    (2) An agency head may start or continue and environmental 
management activity during the pendency of a petition unless the 
petition reasonably indicates such action would result in an emergency.
    (d) Judicial Review.--Agency action with respect to a petition that 
is substantially inconsistent with the recommendations provided by the 
advisory committee under subsections (a)(4)(C)(i), (a)(4)(C)(ii), or 
(a)(4)(D) may be judicially reviewed under any other applicable 
provision of law.

SEC. 11. RISK ASSESSMENT AND PROGRAM PLANNING.

    (a) In General.--In exercising authority under, or complying with, 
applicable laws protecting human health, safety, or the environment, 
the head of an agency shall use risk assessment to set priorities for 
the use of the resources available under those laws, with the goals 
of--
            (1) addressing preferentially the risks to human health, 
        safety, and the environment that the agency determines are the 
        most serious risks that can be addressed in a cost-effective 
        manner, and
            (2) structuring agency actions to achieve promptly the 
        greatest overall net reduction in risks with the private and 
        public sector resources to be expended.
In identifying the most serious risks in paragraph (1), the head of the 
agency shall consider, at a minimum, the likelihood and severity of the 
hazard and the size of the population and natural resources potentially 
affected.
    (b) Annual Report on Risk Assessment Priorities and Program 
Agenda.--In conjunction with the April publication of the regulatory 
agenda required under section 602 of title 5, the head of an agency 
that plans to promulgate one or more major rules concerning human 
health, safety, or the environment shall publish a report on current 
risk assessment priorities of the agency to support such regulatory 
agenda. Such report shall include--
            (1) a prioritized list combining--
                    (A) the most serious risks that the agency believes 
                can be addressed in a cost-effective manner through 
                additional major rules or major risk communication;
                    (B) any other risks that the agency is required by 
                statute, court order, or consent decree to address 
                through the promulgation of additional major rules or 
                major risk communication; and
                    (C) any risks that are to be re-assessed by the 
                agency pursuant to section 10 of this Act.
        Such list shall rank risks on a comparative risk basis to each 
        other, to the extent practicable and without regard to 
        statutory, judicial, or administrative deadlines.
            (2) a list of risk assessments and supporting assessments 
        related to the risks in paragraph (1), including hazard 
        identifications, causation assessments, and exposure 
        assessments, under preparation or for which budgetary resources 
        have been committed by the agency;
            (3) a brief summary of the relevant issues addressed or to 
        be addressed by each assessment in paragraph (2), and their 
        relationship to the risks in paragraph (1);
            (4) an approximate schedule for completing each listed 
        assessment in paragraph (2);
            (5) an identification of potential major rules in the 
        regulatory agenda, potential guidance, or other potential 
        agency actions supported or affected by each assessment in 
        paragraph (2), including any deadlines for such major rules 
        pursuant to statute, court order, or consent decree; and
            (6) the name, address, and telephone number of an agency 
        official knowledgeable concerning each assessment in paragraph 
        (2).
The identification and ranking of risks in paragraph (1) may be carried 
out on the basis of screening analyses, if more complete information is 
not reasonably available.

SEC. 12. RISK ASSESSMENT AND BUDGETARY PRIORITIES.

    (a) Incorporation of Risk-based Priorities Into Budgets and 
Planning.--To the extent consistent with other statutory requirements, 
the head of an agency shall incorporate the priorities identified in 
section 11 into the budget and planning activities of the agency by, in 
the agency's annual budget request to Congress--
            (1) explicitly identifying how the agency's requested funds 
        will be used to address the risks listed in the most recent 
        report under section 11(b)(1); and
            (2) identifying any statutory, judicial, or administrative 
        obstacles to allocating agency resources in accordance with the 
        priorities established under section 11(b)(1).
    (b) Recommendation.--On April 1 of each year, the agency head shall 
submit to Congress specific recommendations for repealing or modifying 
laws that would enable the agency to set priority among its activities 
in accordance with the priorities established under section 11(b)(1).

SEC. 13. RISK ASSESSMENT IMPROVEMENT PROGRAMS.

    (a) Improving Peer Review in Risk Assessment.--The Director of the 
Office of Science and Technology Policy shall develop a systematic 
program to oversee the use of, and quality of, peer review by agencies 
developing risk assessments pursuant to this Act.
    (b) Improving Comparative Risk Assessment.--The Secretary of 
Energy, in consultation with the heads of other agencies, shall direct 
a national program to foster and improve comparative risk analysis as a 
tool in regulatory and environmental management decision making, using, 
among other research performers, the Department of Energy's National 
Laboratories.

SEC. 14. JUDICIAL REVIEW.

    Except as provided for in section 10(d), a risk assessment, peer 
review, cost-benefit analysis, or certification provided for under this 
Act shall not be subject to judicial review separate and apart from any 
final agency action to which it relates, but shall be made part of the 
administrative record for judicial review of any final agency action to 
which it relates.