Home > 104th Congressional Bills > H.R. 1022 (ih) To provide regulatory reform and to focus national economic resources [Introduced in House] ...

H.R. 1022 (ih) To provide regulatory reform and to focus national economic resources [Introduced in House] ...


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104th CONGRESS
  1st Session
                                H. R. 1022

_______________________________________________________________________

                                 AN ACT


 
 To provide regulatory reform and to focus national economic resources 
  on the greatest risks to human health, safety, and the environment 
  through scientifically objective and unbiased risk assessments and 
through the consideration of costs and benefits in major rules, 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 ``Risk Assessment and Cost-Benefit Act 
of 1995''.

SEC. 2. FINDINGS.

    The Congress finds that:
            (1) Environmental, health, and safety regulations have led 
        to dramatic improvements in the environment and have 
        significantly reduced human health risk; however, the Federal 
        regulations that have led to these improvements have been more 
        costly and less effective than they could have been; too often, 
        regulatory priorities have not been based upon a realistic 
        consideration of risk, risk reduction opportunities, and costs.
            (2) The public and private resources available to address 
        health, safety, and environmental concerns are not unlimited; 
        those resources need to be allocated to address the greatest 
        needs in the most cost-effective manner and so that the 
        incremental costs of regulatory alternatives are reasonably 
        related to the incremental benefits.
            (3) To provide more cost-effective and cost-reasonable 
        protection to human health and the environment, regulatory 
        priorities should be based upon realistic consideration of 
        risk; the priority setting process must include scientifically 
        sound, objective, and unbiased risk assessments, comparative 
        risk analysis, and risk management choices that are grounded in 
        cost-benefit principles.
            (4) Risk assessment has proven to be a useful decision 
        making tool; however, improvements are needed in both the 
        quality of assessments and the characterization and 
        communication of findings; scientific and other data must be 
        better collected, organized, and evaluated; most importantly, 
        the critical information resulting from a risk assessment must 
        be effectively communicated in an objective and unbiased manner 
        to decision makers, and from decision makers to the public.
            (5) The public stake holders must be fully involved in the 
        risk-decision making process. They have the right-to-know about 
        the risks addressed by regulation, the amount of risk to be 
        reduced, the quality of the science used to support decisions, 
        and the cost of implementing and complying with regulations. 
        This knowledge will allow for public scrutiny and promote 
        quality, integrity, and responsiveness of agency decisions.
            (6) Although risk assessment is one important method to 
        improve regulatory decision-making, other approaches to secure 
        prompt relief from the burden of unnecessary and overly complex 
        regulations will also be necessary.

SEC. 3. COVERAGE OF ACT.

    This Act does not apply to any of the following:
            (1) A situation that the head of an affected Federal agency 
        determines to be an emergency. In such circumstance, the head 
        of the agency shall comply with the provisions of this Act 
        within as reasonable a time as is practical.
            (2) Activities necessary to maintain military readiness.
            (3) Any individual food, drug, or other product label, or 
        to any risk characterization appearing on any such label, if 
        the individual product label is required by law to be approved 
        by a Federal department or agency prior to use.
            (4) Approval of State programs or plans by Federal 
        agencies.

SEC. 4. UNFUNDED MANDATES.

    Nothing in this Act itself shall, without Federal funding and 
further Federal agency action, create any new obligation or burden on 
any State or local government or otherwise impose any financial burden 
on any State or local government in the absence of Federal funding, 
except with respect to routine information requests.

SEC. 5. DEFINITIONS.

    For purposes of this Act:
            (1) Costs.--The term ``costs'' includes the direct and 
        indirect costs to the United States Government, to State, 
        local, and tribal governments, and to the private sector, wage 
        earners, consumers, and the economy, of implementing and 
        complying with a rule or alternative strategy.
            (2) Benefit.--The term ``benefit'' means the reasonably 
        identifiable significant health, safety, environmental, social 
        and economic benefits that are expected to result directly or 
        indirectly from implementation of a rule or alternative 
        strategy.
            (3) Major rule.--The term ``major rule'' means any 
        regulation that is likely to result in an annual increase in 
        costs of $25,000,000 or more. Such term does not include any 
        regulation or other action taken by an agency to authorize or 
        approve any individual substance or product.
            (4) Program designed to protect human health.--The term 
        ``program designed to protect human health'' does not include 
        regulatory programs concerning health insurance, health 
        provider services, or health care diagnostic services.
            (5) Emergency.--As used in this Act, the term ``emergency'' 
        means a situation that is immediately impending and 
        extraordinary in nature, demanding attention due to a 
        condition, circumstance, or practice reasonably expected to 
        cause death, serious illness, or severe injury to humans, or 
        substantial endangerment to private property or the environment 
        if no action is taken.

SEC. 6. AVAILABILITY OF INFORMATION AMONG FEDERAL AGENCIES.

    Covered Federal agencies shall make existing databases and 
information developed under this Act available to other Federal 
agencies, subject to applicable confidentiality requirements, for the 
purpose of meeting the requirements of this Act. Within 15 months after 
the date of enactment of this Act, the President shall issue guidelines 
for Federal agencies to comply with this section.

               TITLE I--RISK ASSESSMENT AND COMMUNICATION

SEC. 101. SHORT TITLE.

    This title may be cited as the ``Risk Assessment and Communication 
Act of 1995''.

SEC. 102. PURPOSES.

    The purposes of this title are--
            (1) to present the public and executive branch with the 
        most scientifically objective and unbiased information 
        concerning the nature and magnitude of health, safety, and 
        environmental risks in order to provide for sound regulatory 
        decisions and public education;
            (2) to provide for full consideration and discussion of 
        relevant data and potential methodologies;
            (3) to require explanation of significant choices in the 
        risk assessment process which will allow for better peer review 
        and public understanding; and
            (4) to improve consistency within the executive branch in 
        preparing risk assessments and risk characterizations.

SEC. 103. EFFECTIVE DATE; APPLICABILITY; SAVINGS PROVISIONS.

    (a) Effective Date.--Except as otherwise specifically provided in 
this title, the provisions of this title shall take effect 18 months 
after the date of enactment of this title.
    (b) Applicability.--
            (1) In general.--Except as provided in paragraph (3), this 
        title applies to all significant risk assessment documents and 
        significant risk characterization documents, as defined in 
        paragraph (2).
            (2) Significant risk assessment document or significant 
        risk characterization document.--(A) As used in this title, the 
        terms ``significant risk assessment document'' and 
        ``significant risk characterization document'' include, at a 
minimum, risk assessment documents or risk characterization documents 
prepared by or on behalf of a covered Federal agency in the 
implementation of a regulatory program designed to protect human 
health, safety, or the environment, used as a basis for one of the 
items referred to in subparagraph (B), and--
                    (i) included by the agency in that item; or
                    (ii) inserted by the agency in the administrative 
                record for that item.
            (B) The items referred to in subparagraph (A) are the 
        following:
                    (i) Any proposed or final major rule, including any 
                analysis or certification under title II, promulgated 
                as part of any Federal regulatory program designed to 
                protect human health, safety, or the environment.
                    (ii) Any proposed or final environmental clean-up 
                plan for a facility or Federal guidelines for the 
                issuance of any such plan. As used in this clause, the 
                term ``environmental clean-up'' means a corrective 
                action under the Solid Waste Disposal Act, a removal or 
                remedial action under the Comprehensive Environmental 
                Response, Compensation, and Liability Act of 1980, and 
                any other environmental restoration and waste 
                management carried out by or on behalf of a covered 
                Federal agency with respect to any substance other than 
                municipal waste.
                    (iii) Any proposed or final permit condition 
                placing a restriction on facility siting or operation 
                under Federal laws administered by the Environmental 
                Protection Agency or the Department of the Interior. 
                Nothing in this section (iii) shall apply to the 
                requirements of section 404 of the Clean Water Act.
                    (iv) Any report to Congress.
                    (v) Any regulatory action to place a substance on 
                any official list of carcinogens or toxic or hazardous 
                substances or to place a new health effects value on 
                such list, including the Integrated Risk Information 
                System Database maintained by the Environmental 
                Protection Agency.
                    (vi) Any guidance, including protocols of general 
                applicability, establishing policy regarding risk 
                assessment or risk characterization.
            (C) The terms ``significant risk assessment document'' and 
        ``significant risk characterization document'' shall also 
        include the following:
                    (i) Any such risk assessment and risk 
                characterization documents provided by a covered 
                Federal agency to the public and which are likely to 
                result in an annual increase in costs of $25,000,000 or 
                more.
                    (ii) Environmental restoration and waste management 
                carried out by or on behalf of the Department of 
                Defense with respect to any substance other than 
                municipal waste.
            (D) Within 15 months after the date of the enactment of 
        this Act, each covered Federal agency administering a 
        regulatory program designed to protect human health, safety, or 
        the environment shall promulgate a rule establishing those 
        additional categories, if any, of risk assessment and risk 
        characterization documents prepared by or on behalf of the 
        covered Federal agency that the agency will consider 
        significant risk assessment documents or significant risk 
        characterization documents for purposes of this title. In 
        establishing such categories, the head of the agency shall 
        consider each of the following:
                    (i) The benefits of consistent compliance by 
                documents of the covered Federal agency in the 
                categories.
                    (ii) The administrative burdens of including 
                documents in the categories.
                    (iii) The need to make expeditious administrative 
                decisions regarding documents in the categories.
                    (iv) The possible use of a risk assessment or risk 
                characterization in any compilation of risk hazards or 
                health or environmental effects prepared by an agency 
                and commonly made available to, or used by, any 
                Federal, State, or local government agency.
                    (v) Such other factors as may be appropriate.
            (E)(i) Not later than 18 months after the date of the 
        enactment of this Act, the President, acting through the 
        Director of the Office of Management and Budget, shall 
        determine whether any other Federal agencies should be 
        considered covered Federal agencies for purposes of this title. 
        Such determination, with respect to a particular Federal 
        agency, shall be based on the impact of risk assessment 
        documents and risk characterization documents on--
                    (I) regulatory programs administered by that 
                agency; and
                    (II) the communication of risk information by that 
                agency to the public.
        The effective date of such a determination shall be no later 
        than 6 months after the date of the determination.
            (ii) Not later than 15 months after the President, acting 
        through the Director of the Office of Management and Budget, 
        determines pursuant to clause (i) that a Federal agency should 
        be considered a covered Federal agency for purposes of this 
        title, the head of that agency shall promulgate a rule pursuant 
        to subparagraph (D) to establish additional categories of risk 
        assessment and risk characterization documents described in 
        that subparagraph.
            (3) Exceptions.--(A) This title does not apply to risk 
        assessment or risk characterization documents containing risk 
        assessments or risk characterizations performed with respect to 
        the following:
                    (i) A screening analysis, where appropriately 
                labeled as such, including a screening analysis for 
                purposes of product regulation or premanufacturing 
                notices.
                    (ii) Any health, safety, or environmental 
                inspections.
                    (iii) The sale or lease of Federal resources or 
                regulatory activities that directly result in the 
                collection of Federal receipts.
            (B) No analysis shall be treated as a screening analysis 
        for purposes of subparagraph (A) if the results of such 
        analysis are used as the basis for imposing restrictions on 
        substances or activities.
            (C) The risk assessment principle set forth in section 
        104(b)(1) need not apply to any risk assessment or risk 
        characterization document described in clause (iii) of 
        paragraph (2)(B). The risk characterization and communication 
        principle set forth in section 105(4) need not apply to any 
        risk assessment or risk characterization document described in 
        clause (v) or (vi) of paragraph (2)(B).
    (c) Savings Provisions.--The provisions of this title shall be 
supplemental to any other provisions of law relating to risk 
assessments and risk characterizations, except that nothing in this 
title shall be construed to modify any statutory standard or statutory 

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