104th Congress > House > Vote 176
Clerk session vote number: 183
Description: Risk Assessment and Cost-Benefit Act
Bill summary: TABLE OF CONTENTS:
Title I: Risk Assessment and Communication
Title II: Analysis of Risk Reduction Benefits and Costs
Title III: Peer Review
Title IV: Judicial Review
Title V: Plan
Title VI: Priorities
Risk Assessment and Cost-Benefit Act of 1995 - Declares that this Act shall not apply to: (1) an emergency situation, in which case the agency head shall comply with this Act within as reasonable a time as is practical; (2) activities necessary to maintain military readiness; (3) any
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individual food, drug, or other product label, or 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; and (4) Federal agency approval of State programs or plans.
(Sec. 4) Provides that nothing in this Act 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. 6) Requires covered Federal agencies to 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.
Title I: Risk Assessment and Communication
- Risk Assessment and Communication Act of 1995 - Applies this title generally to all significant risk assessment and risk characterization documents, except: (1) screening analyses; (2) health, safety, or environmental inspections; (3) facility siting or operation restrictions on permits to discharge dredged or fill material into navigable waters under the Clean Water Act; or (4) the sale or lease of Federal resources or regulatory activities that directly result in collection of Federal receipts.
(Sec. 104) Requires each covered Federal agency head to apply specified principles in order to assure that significant risk assessment documents and all of their components distinguish scientific findings from other considerations and are, to the extent feasible, scientifically objective, unbiased, and inclusive of all relevant data and rely, to the extent available and practicable, on scientific findings.
(Sec. 105) Specifies the requirements that each significant risk characterization document is required to meet.
(Sec. 106) Prohibits any covered Federal agency from automatically incorporating or adopting any recommendation or classification made by a non-United States-based entity concerning the health effects value of a substance without an opportunity for notice and comment.
Specifies as a non-United States-based entity: (1) any foreign government and its agencies; (2) the United Nations or any of its subsidiary organizations; (3) any other international governmental body or international standards-making organization; or (4) any other organization or private entity without a place of business in the United States or its territories.
Requires compliance with this title by any risk assessment document or risk characterization document adopted by a covered Federal agency on the basis of such a recommendation or classification.
(Sec. 107) Directs the President to: (1) issue guidelines for Federal agencies consistent with specified risk assessment and characterization principles; and (2) provide a format for summarizing risk assessment results. Requires such guidelines to include guidance on such subjects such as the evaluation of benign tumors and the use of different types of dose-response models. Requires the President to periodically review and revise such guidelines as appropriate.
(Sec. 108) Directs each covered Federal agency head to do the following for periodic reports to the Congress: (1) regularly and systematically evaluate risk assessment research and training needs of the agency; and (2) develop a strategy and schedule for carrying out research and training to meet certain such needs.
(Sec. 109) Requires the Director of the Office of Management and Budget (OMB) to provide for a study using comparative risk analysis to rank health, safety, and environmental risks and to provide a common basis for evaluating strategies for reducing or preventing those risks. Requires the Director to submit to the Congress a report of the National Research Council with recommendations regarding the use of comparative risk analysis and ways to improve the use of comparative risk analysis for decision-making in appropriate Federal agencies.
(Sec. 110) Limits covered Federal agencies to: (1) the Environmental Protection Agency; (2) the Occupational Safety and Health Administration; (3) the Food and Drug Administration; (4) the Consumer Product Safety Commission; (5) the Department of Transportation; (6) the Department of Energy; (7) the Department of Agriculture; (8) the Department of the Interior; (9) the Nuclear Regulatory Commission; (10) the National Oceanic and Atmospheric Administration; (11) the U.S. Army Corps of Engineers; (12) the Mine Safety and Health Administration; and (13) other Federal agencies determined by the President, acting through the OMB Director.
Title II: Analysis of Risk Reduction Benefits and Costs
- Requires the President to require each Federal agency to prepare specified analyses for each new major rule within a program designed to protect human health, safety, or the environment.
(Sec. 202) Requires that certain certifications be made in order for a final rule subject to this title to be promulgated.
(Sec. 203) Directs OMB to issue guidance consistent with this title: (1) to assist the agencies, the public, and the regulated community in the implementation of this title, including any new requirements or procedures needed to supplement prior agency practice; and (2) to govern the development and preparation of analyses of risk reduction benefits and costs.
(Sec. 204) Provides that for purposes of this title, any determination by a Federal agency to approve or reject any proposed or final environmental clean-up plan for a facility the costs of which are likely to exceed $5 million shall be treated as a major rule generally subject to this title.
Title III: Peer Review
- Requires each Federal agency head to develop a systematic program for independent and external peer review for regulatory programs designed to protect human health, safety, or the environment in connection with any risk assessment or cost analysis forming the basis of any rule likely to result in an annual increase in costs of $100 million or more. Exempts from such requirement: (1) any rule or other action taken by an agency to authorize or approve any individual substance or product; and (2) any data or method which has been previously subjected to peer review or any component of any analysis or assessment previously subjected to peer review.
Authorizes the OMB Director to order that peer review be provided for any major risk assessment or cost assessment likely to have a significant impact on public policy decisions.
Directs the President to appoint National Peer Review Panels to review annually for a report to the Congress the risk and cost assessment practices of each Federal agency for programs designed to protect human health, safety, or the environment.
Title IV: Judicial Review
- Provides for judicial review under this Act.
Title V: Plan
- Requires each covered Federal agency to publish a plan to review and, where appropriate, revise significant risk assessment or characterization documents if the agency head determines that application of the appropriate specified principles for risk assessment and risk characterization and communication would be likely to alter significantly the results of the prior risk assessment or characterization. Provides for public participation and consultation in plan development.
Title VI: Priorities
- Directs the President, in order to assist in the public policy and regulation of risks to public health, to identify specified opportunities to reflect priorities within existing Federal regulatory programs designed to protect human health in a cost-effective and cost-reasonable manner.
(Sec. 601) Requires the President to issue biennial reports to the Congress recommending priorities for modifications to, elimination of, or strategies for existing Federal regulatory programs designed to protect public health. Requires an agency to consider the priorities set forth in the report, and priorities developed and submitted by State, local, and tribal governments, when preparing a budget or strategic plan for any such regulatory program.
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Bill titles: 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.
Links for more info on the vote: congress.gov
