| Home > 104th Congressional Bills > H.R. 1023 (ih) To provide procedures for claims for compassionate payments with regard to individuals with blood-clotting disorders, such as hemophilia, who contracted human immunodeficiency virus due to contaminated blood products. [Introduced in House]...
H.R. 1023 (ih) To provide procedures for claims for compassionate payments with regard to individuals with blood-clotting disorders, such as hemophilia, who contracted human immunodeficiency virus due to contaminated blood products. [Introduced in House]...
104th CONGRESS 1st Session H. R. 1022 _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES March 2 (legislative day, February 22), 1995 Received; read twice and referred to the Committee on Governmental Affairs _______________________________________________________________________ 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.
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