[Congressional Record Volume 141, Number 112 (Wednesday, July 12, 1995)]
[Senate]
[Pages S9811-S9817]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                          AMENDMENTS SUBMITTED

                                 ______


            THE COMPREHENSIVE REGULATORY REFORM ACT OF 1995

                                 ______


                        HATCH AMENDMENT NO. 1498

  Mr. HATCH proposed an amendment to amendment No. 1487 proposed by Mr. 
Dole to the bill (S. 343) to reform the regulatory process, and for 
other purposes; as follows:

       Delete all of section 635 (page 61, line 1 through page 64, 
     line 14 and insert the following new section 635:

     SECTION 635. RISK-BASED PRIORITIES.

       (a) Purposes.--The purposes of this section are to--
       (1) encourage Federal agencies engaged in regulating risks 
     to human health, safety, and the environment to achieve the 
     greatest risk reduction at the least cost practical;
       (2) promote the coordination of policies and programs to 
     reduce risks to human health, safety, and the environment; 
     and
       (3) promote open communication among Federal agencies, the 
     public, the President, and Congress regarding environmental, 
     health, and safety risks, and the prevention and management 
     of those risks.
       (b) Definitions.--For the purposes of this section:
       (1) Comparative risk analysis.--The term ``comparative risk 
     analysis'' means a process to systematically estimate, 
     compare, and rank the size and severity of risks to provide a 
     common basis for evaluating strategies for reducing or 
     preventing those risks.
       (2) Covered agency.--The term ``covered agency'' means each 
     of the following:
       (A) The Environmental Protection Agency.
       (B) The Department of Labor.
       (C) The Department of Transportation.
       (D) The Food and Drug Administration.
       (E) The Department of Energy.
       (F) The Department of the Interior.
       (G) The Department of Agriculture.
       (H) The Consumer Product Safety Commission.
       (I) The National Oceanic and Atmospheric Administration.
       (J) The United States Army Corps of Engineers.
       (K) The Nuclear Regulatory Commission.
       (3) Effect.--The term ``effect'' means a deleterious change 
     in the condition of--
       (A) a human or other living thing (including death, cancer, 
     or other chronic illness, decreased reproductive capacity, or 
     disfigurement); or
       (B) an inanimate thing important to human welfare 
     (including destruction, degeneration, the loss of intended 
     function, and increased costs for maintenance).
       (4) Irreversibility.--The term ``irreversibility'' means 
     the extent to which a return to conditions before the 
     occurrence of an effect are either very slow or will never 
     occur.
       (5) Likelihood.--The term ``likelihood'' means the 
     estimated probability that an effect will occur.
       (6) Magnitude.--The term ``magnitude'' means the number of 
     individuals or the quantity of ecological resources or other 
     resources that contribute to human welfare that are affected 
     by exposure to a stressor.
       (7) Seriousness.--The term ``seriousness'' means the 
     intensity of effect, the likelihood, the irreversibility, and 
     the magnitude.
       (c) Department and Agency Program Goals.--
       (1) Setting priorities.--In exercising authority under 
     applicable laws protecting human health, safety, or the 
     environment, the head of each covered agency should set 
     priorities and use the resources available under those laws 
     to address those risks to human health, safety, and the 
     environment that--
       (A) the covered agency determines to be the most serious; 
     and
       (B) 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 expended.
       (2) Determining the most serious risks.--In identifying the 
     greatest risks under paragraph (1) of this subsection, each 
     covered agency shall consider, at a minimum--
       (A) the likelihood, irreversibility, and severity of the 
     effect; and
       (B) the number and classes of individuals potentially 
     affected, and shall explicitly take into account the results 
     of the comparative risk analysis conducted under subsection 
     (d) of this section.
       (3) OMB review.--The covered agency's determinations of the 
     most serious risks for purposes of setting priorities shall 
     be reviewed and approved by the Director of the Office of 
     Management and Budget before submission of the covered 
     agency's annual budget requests to Congress.
       (4) Incorporating risk-based priorities into budget and 
     planning.--The head of each covered agency shall incorporate 
     the priorities identified under paragraph (1) into the agency 
     budget, strategic planning, regulatory agenda, enforcement, 
     and research activities. When submitting its budget request 
     to Congress and when announcing its regulatory agenda in the 
     Federal Register, each covered agency shall identify the 
     risks that the covered agency head has determined are the 
     most serious and can be addressed in a cost-effective manner 
     under paragraph (1), the basis for that determination, and 
     explicitly identify how the covered agency's requested budget 
     and regulatory agenda reflect those priorities.
       (5) Effective date.--This subsection shall take effect 12 
     months after the date of enactment of this Act.
       (d) Comparative Risk Analysis.--
       (1) Requirement.--(A)(i) No later than 6 months after the 
     effective date of this Act, the Director of the Office of 
     Management and Budget shall enter into appropriate 
     arrangements with an accredited scientific body--
       (I) to conduct a study of the methodologies for using 
     comparative risk to rank dissimilar human health, safety, and 
     environmental risks; and
       (II) to conduct a comparative risk analysis.
       (ii) The comparative risk analysis shall compare and rank, 
     to the extent feasible, human health, safety, and 
     environmental risks potentially regulated across the spectrum 
     of programs administered by all covered agencies.
       (B) The Director shall consult with the Office of Science 
     and Technology Policy regarding the scope of the study and 
     the conduct of the comparative risk analysis.
       (2) Criteria.--In arranging for the comparative risk 
     analysis referred to in paragraph (1) of this subsection, the 
     Director shall ensure that--
       (A) the scope and specificity of the analysis are 
     sufficient to provide the President and agency heads guidance 
     in allocating resources across agencies and among programs in 
     agencies to achieve the greatest degree of risk prevention 
     and reduction for the public and private resources expended;
       (B) the analysis is conducted through an open process, by 
     individuals with relevant expertise, including toxicologists, 
     biologists, engineers and experts in medicine, industrial 
     hygiene and environmental effects;
       (C) the analysis is conducted, to the extent feasible, 
     consistent with the risk assessment and risk characterization 
     principles in sections 635 and 636 of this title;
       (D) the methodologies and principle scientific 
     determinations made in the analysis are subjected to 
     independent and external peer review consistent with section 
     635, and the conclusions of the peer review are made publicly 
     available as part of the final report required under 
     subsection (e);
       (E) there is an opportunity for public comment on the 
     results before making them final; and
       (F) the results are presented in a manner that 
     distinguishes between the scientific conclusions and any 
     policy or value judgments embodied in the comparisons.
       (3) Completion and review.--No later than 3 years after the 
     effective date of this Act, the comparative risk analysis 
     required under paragraph (1) shall be completed. The 
     comparative risk analysis shall be reviewed and revised at 
     least every 5 years thereafter for a minimum of 15 years 
     following the release of the first analysis. The Director 
     shall arrange for such review and revision with an accredited 
     scientific body in the same manner as provided under 
     paragraphs (1) and (2).
       (4) Study.--The study of methodologies provided under 
     paragraph (1) shall be conducted as part of the first 
     comparative risk 

[[Page S 9812]]
     analysis and shall be completed no later than 180 days after the 
     completion of that analysis. The goal of the study shall be 
     to develop and rigorously test methods of comparative risk 
     analysis. The study shall have sufficient scope and breadth 
     to test approaches for improving comparative risk analysis 
     and its use in setting priorities for human health, safety, 
     and environmental risk prevention and reduction.
       (5) Technical guidance.--No later than 180 days after the 
     effective date of this Act, the Director, in collaboration 
     with other heads of covered agencies shall enter into a 
     contract with the National Research Council to provide 
     technical guidance to agencies on approaches to using 
     comparative risk analysis in setting human health, safety, 
     and environmental priorities to assist in complying with 
     subsection (c) of this section.
       (e) Reports and Recommendations to Congress and the 
     President.--No later than 24 months after the effective date 
     of this Act, each covered agency shall submit a report to 
     Congress and the President--
       (1) detailing how the agency has complied with subsection 
     (c) and describing the reasons for any departure from the 
     requirement to establish priorities to achieve the greatest 
     overall net reduction in risk;
       (2) recommending--
       (A) modification, repeal, or enactment of laws reform, 
     eliminate, or enhance programs or mandates relating to human 
     health, safety, or the environment; and
       (B) modification or elimination of statutorily or 
     judicially mandated deadlines,

     that would assist the covered agency to set priorities in 
     activities to address the risks to human health, safety, or 
     the environment in a manner consistent with the requirements 
     of subsection (c)(1);
       (3) evaluating the categories of policy and value judgments 
     used in risk assessment, risk characterization, or cost-
     benefit analysis; and
       (4) discussing risk assessment research and training needs, 
     and the agency's strategy and schedule for meeting those 
     needs.
       (f) Savings Provision and Judicial Review.--
       (1) In general.--Nothing in this section shall be construed 
     to modify any statutory standard or requirement designed to 
     protect human health, safety, or the environment.
       (2) Judical review.--Compliance or noncompliance by an 
     agency with the provisions of this section shall not be 
     subject to judicial review.
       (3) Agency analysis.--Any analysis prepared under this 
     section shall not be subject to judicial consideration 
     separate or apart from the requirement, rule, program, or law 
     to which it relates. When an action for judicial review of a 
     covered agency action is instituted, any analysis for, or 
     relating to, the action shall constitute part of the whole 
     record of agency action for the purpose of judicial review of 
     the action and shall, to the extent relevant, be considered 
     by a court in determining the legality of the covered agency 
     action.

                                 ______


                        HATCH AMENDMENT NO. 1499

  Mr. HATCH proposed an amendment to amendment No. 1498 proposed by him 
to the bill S. 343, supra; as follows:

       In lieu of the language proposed to be inserted, insert:

     SECTION 635. RISK-BASED PRIORITIES.

       (a) Purposes.--The proposes of this section are to--
       (1) encourage Federal agencies engaged in regulating risks 
     to human health, safety, and the environment to achieve the 
     greatest risk reduction at the least cost practical;
       (2) promote the coordination of policies and programs to 
     reduce risks to human health, safety, and the environment; 
     and
       (3) promote open communication among Federal agencies, the 
     public, the President, and Congress regarding environmental, 
     health, and safety risks, and the prevention and management 
     of those risks.
       (b) Definitions.--For the purposes of this section:
       (1) Comparative risk analysis.--The term ``comparative risk 
     analysis'' means a process to systematically estimate, 
     compare, and rank the size and severity of risks to provide a 
     common basis for evaluating strategies for reducing or 
     preventing those risks.
       (2) Covered agency.--The term ``covered agency'' means each 
     of the following:
       (A) The Environmental Protection Agency.
       (B) The Department of Labor.
       (C) The Department of Transportation.
       (D) The Food and Drug Administration.
       (E) The Department of Energy.
       (F) The Department of the Interior.
       (G) The Department of Agriculture.
       (H) The Consumer Product Safety Commission.
       (I) The National Oceanic and Atmospheric Administration.
       (J) The United States Army Corps of Engineers.
       (K) The Nuclear Regulatory Commission.
       (3) Effect.--The term ``effect'' means a deleterious change 
     in the condition of--
       (A) a human or other living thing (including death, cancer, 
     or other chronic illness, decreased reproductive capacity, or 
     disfigurement); or
       (B) an inanimate thing important to human welfare 
     (including destruction, degeneration, the loss of intended 
     function, and increased costs for maintenance).
       (4) Irreversibility.--The term 
     ``irreversibil
     ity'' means the extent to which a return to conditions before 
     the occurrence of an effect are either very slow or will 
     never occur.
       (5) Likelihood.--The term ``likelihood'' means the 
     estimated probability that an effect will occur.
       (6) Magnitude.--The term ``magnitude'' means the number of 
     individuals or the quantity of ecological resources or other 
     resources that contribute to human welfare that are affected 
     by exposure to a stressor.
       (7) Seriousness.--The term ``seriousness'' means the 
     intensity of effect, the likelihood, the irreversibility, and 
     the magnitude.
       (c) Department and Agency Program Goals.--
       (1) Setting priorities.--In exercising authority under 
     applicable laws protecting human health, safety, or the 
     environment, the head of each covered agency should set 
     priorities and use the resources available under those laws 
     to address those risks to human health, safety, and the 
     environment that--
       (A) the covered agency determines to be the most serious, 
     and
       (B) 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 expended.
       (2) Determining the most serious risks.--In identifying the 
     greatest risks under paragraph (1) of this subsection, each 
     covered agency shall consider, at a minimum--
       (A) the likelihood, irreversibility, and severity of the 
     effect; and
       (B) the number and classes of individuals potentially 
     affected, and shall explicitly take into account the results 
     of the comparative risk analysis conducted under subsection 
     (d) of this section.
       (3) OMB review.--The covered agency's determinations of the 
     most serious risks for purposes of setting priorities shall 
     be reviewed and approved by the Director of the Office of 
     Management and Budget before submission of the covered 
     agency's annual budget requests to Congress.
       (4) Incorporating risk-based priorities into budget and 
     planning.--The head of each covered agency shall incorporate 
     the priorities identified under paragraph (1) into the agency 
     budget, strategic planning, regulatory agenda, enforcement, 
     and research activities. When submitting its budget request 
     to Congress and when announcing its regulatory agenda in the 
     Federal Register, each covered agency shall identify the 
     risks that the covered agency head has determined are the 
     most serious and can be addressed in a cost-effective manner 
     under paragraph (1), the basis for that determination, and 
     explicitly identify how the covered agency's requested budget 
     and regulatory agenda reflect those priorities.
       (5) Effective date.--This subsection shall take effect 12 
     months after the date of enactment of this Act.
       (d) Comparative Risk Analysis.--
       (1) Requirement.--(A)(i) No later than 6 months after the 
     effective date of this Act, the Director of the Office of 
     Management and Budget shall enter into appropriate 
     arrangements with an accredited scientific body--
       (I) to conduct a study of the methodologies for using 
     comparative risk to rank dissimilar human health, safety, and 
     environmental risks; and
       (II) to conduct a comparative risk analysis.
       (ii) The comparative risk analysis shall compare and rank, 
     to the extent feasible, human health, safety, and 
     environmental risks potentially regulated across the spectrum 
     of programs administered by all covered agencies.
       (B) The Director shall consult with the Office of Science 
     and Technology Policy regarding the scope of the study and 
     the conduct of the comparative risk analysis.
       (2) Criteria.--In arranging for the comparative risk 
     analysis referred to in paragraph (1) of this subsection, the 
     Director shall ensure that--
       (A) the scope and specificity of the analysis are 
     sufficient to provide the President and agency heads guidance 
     in allocating resources across agencies and among programs in 
     agencies to achieve the greatest degree of risk prevention 
     and reduction for the public and private resources expended;
       (B) the analysis is conducted through an open process, by 
     individuals with relevant expertise, including toxicologists, 
     biologists, engineers and experts in medicine, industrial 
     hygiene and environmental effects;
       (C) the analysis is conducted, to the extent feasible, 
     consistent with the risk assessment and risk characterization 
     principles in section 633 of this title;
       (D) the methodologies and principal scientific 
     determinations made in the analysis are subjected to 
     independent and external peer review consistent with section 
     633(g), and the conclusions of the peer review are made 
     publicly available as part of the final report required under 
     subsection (e);
       (E) there is an opportunity for public comment on the 
     results before making them final; and
       (F) the results are presented in a manner that 
     distinguishes between the scientific conclusions and any 
     policy or value judgments embodied in the comparisons.
       (3) Completion and review.--No later than 3 years after the 
     effective date of this Act, the comparative risk analysis 
     required under paragraph (1) shall be completed. The 
     comparative risk analysis shall be reviewed and revised at 
     least every 5 years thereafter for a minimum of 15 years 
     following the release of the first analysis. The Director 
     shall arrange for such review and revision with an 

[[Page S 9813]]
     accredited scientific body in the same manner as provided under 
     paragraphs (1) and (2).
       (4) Study.--The study of methodologies provided under 
     paragraph (1) shall be conducted as part of the first 
     comparative risk analysis and shall be completed no later 
     than 180 days after the completion of that analysis. The goal 
     of the study shall be to develop and rigorously test methods 
     of comparative risk analysis. The study shall have sufficient 
     scope and breadth to test approaches for improving 
     comparative risk analysis and its use in setting priorities 
     for human health, safety, and environmental risk prevention 
     and reduction.
       (5) Technical guidance.--No later than 180 days after the 
     effective date of this Act, the Director, in collaboration 
     with other heads of covered agencies shall enter into a 
     contract with the National Research Council to provide 
     technical guidance to agencies on approaches to using 
     comparative risk analysis in setting human health, safety, 
     and environmental priorities to assist agencies in complying 
     with subsection (c) of this section.
       (e) Reports and Recommendations to Congress and the 
     President.--No later than 24 months after the effective date 
     of this Act, each covered agency shall submit a report to 
     Congress and the President--
       (1) detailing how the agency has complied with subsection 
     (c) and describing the reasons for any departure from the 
     requirement to establish priorities to achieve the greatest 
     overall net reduction in risk;
       (2) recommending--
       (A) modification, repeal, or enactment of laws to reform, 
     eliminate, or enhance programs or mandates relating to human 
     health, safety, or the environment; and
       (B) modification or elimination of statutorily or 
     judicially mandated deadlines,

     that would assist the covered agency to set priorities in 
     activities to address the risks to human health, safety, or 
     the environment in a manner consistent with the requirements 
     of subsection (c)(1);
       (3) evaluating the categories of policy and value judgments 
     used in risk assessment, risk characterization, or cost-
     benefit analysis; and
       (4) discussing risk assessment research and training needs, 
     and the agency's strategy and schedule for meeting those 
     needs.
       (f) Savings Provision and Judicial Review.--
       (1) In general.--Nothing in this section shall be construed 
     to modify any statutory standard or requirement designed to 
     protect human health, safety, or the environment.
       (2) Judicial review.--Compliance or noncompliance by an 
     agency with the provisions of this section shall not be 
     subject to judicial review.
       (3) Agency analysis.--Any analysis prepared under this 
     section shall not be subject to judicial consideration 
     separate or apart from the requirement, rule, program, or law 
     to which it relates. When an action for judicial review of a 
     covered agency action is instituted, any analysis for, or 
     relating to, the action shall constitute part of the whole 
     record of agency action for the purpose of judicial review of 
     the action and shall, to the extent relevant, be considered 
     by a court in determining the legality of the covered agency 
     action.
                                 ______


                        ROTH AMENDMENT NO. 1500

  Mr. HATCH (for Mr. Roth) proposed an amendment to the bill S. 343, 
supra; as follows:

       Strike the word ``analysis'' in the bill and insert the 
     following:

     ``analysis.
       ``Section 635 is deemed to read as follows:

     SEC. 635. RISK-BASED PRIORITIES.

       (a) Purposes.--The purposes of this section are to--
       (1) encourage Federal agencies engaged in regulating risks 
     to human health, safety, and the environment to achieve the 
     greatest risk reduction at the least cost practical;
       (2) promote the coordination of policies and programs to 
     reduce risks to human health, safety, and the environment; 
     and
       (3) promote open communication among Federal agencies, the 
     public, the President, and Congress regarding environmental, 
     health, and safety risks, and the prevention and management 
     of those risks.
       (b) Definitions.--For the purposes of this section:
       (1) Comparative risk analysis.--The term ``comparative risk 
     analysis'' means a process to systematically estimate, 
     compare, and rank the size and severity of risks to provide a 
     common basis for evaluating strategies for reducing or 
     preventing those risks.
       (2) Covered agency.--the term ``covered agency'' means each 
     of the following:
       (A) The Environmental Protection Agency:
       (B) The Department of Labor.
       (C) The Department of Transportation.
       (D) The Food and Drug Administration.
       (E) The Department of Energy.
       (F) The Department of the Interior.
       (G) The Department of Agriculture.
       (H) The Consumer Product Safety Commission.
       (I) The National Oceanic and Atmospheric Administration.
       (J) The United States Army Corps of Engineers.
       (K) The Nuclear Regulatory Commission.
       (3) Effect.--The term ``effect'' means a deleterious change 
     in the condition of--
       (A) a human or other living thing (including death, cancer, 
     or other chronic illness, decreased reproductive capacity, or 
     disfigurement); or
       (B) an inanimate thing important to human welfare 
     (including destruction, degeneration, the loss of intended 
     function, and increased costs for maintenance).
       (4) Irreversibility.--The term ``irreversibility'' means 
     the extent to which a return to conditions before the 
     occurrence of an effect are either very slow or will never 
     occur.
       (5) Likelihood.--The term ``likelihood'' means the 
     estimated probability that an effect will occur.
       (6) Magnitude.--The term ``magnitude'' means the number of 
     individuals or the quantity of ecological resources or other 
     resources that contribute to human welfare that are affected 
     by exposure to a stressor.
       (7) Seriousness.--The term ``seriousness'' means the 
     intensity of effect, the likelihood, the irreversibility, and 
     the magnitude.
       (c) Department and Agency Program Goals.--
       (1) Setting priorities.--In exercising authority under 
     applicable laws protecting human health, safety, or the 
     environment, the head of each covered agency should set 
     priorities and use the resources available under those laws 
     to address those risks to human health, safety, and the 
     environment that--
       (A) the covered agency determines to be the most serious; 
     and
       (B) 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 expended.
       (2) Determining the most serious risks.--In identifying the 
     greatest risks under paragraph (1) of this subsection, each 
     covered agency shall consider, at a minimum--
       (A) the likelihood, irreversibility, and severity of the 
     effect; and
       (B) the number and classes of individuals potentially 
     affected, and shall explicitly take into account the results 
     of the comparative risk analysis conducted under subsection 
     (d) of this section.
       (3) OMB review.--The covered agency's determinations of the 
     most serious risks for purposes of setting priorities shall 
     be reviewed and approved by the Director of the Office of 
     Management and Budget before submission of the covered 
     agency's annual budget requests to Congress.
       (4) Incorporating risk-based priorities into budget and 
     planning.--The head of each covered agency shall incorporate 
     the priorities identified under paragraph (1) into the agency 
     budget, strategic planning, regulatory agenda, enforcement, 
     and research activities. When submitting its budget request 
     to Congress and when announcing its regulatory agenda in the 
     Federal Register, each covered agency shall identify the 
     risks that the covered agency head has determined are the 
     most serious and can be addressed in a cost-effective manner 
     under paragraph (1), the basis for that determination, and 
     explicitly identify how the covered agency's requested budget 
     and regulatory agenda reflect those priorities.
       (5) Effective date.--This subsection shall take effect 12 
     months after the date of enactment of this Act.
       (d) Comparative Risk Analysis.--
       (1) Requirement.--(A)(i) No later than 6 months after the 
     effective date of this Act, the Director of the Office of 
     Management and Budget shall enter into appropriate 
     arrangements with an accredited scientific body--
       (I) to conduct a study of the methodologies for using 
     comparative risk to rank dissimilar human health, safety, and 
     environmental risks; and
       (II) to conduct a comparative risk analysis.
       (ii) The comparative risk analysis shall compare and rank, 
     to the extent feasible, human health, safety, and 
     environmental risks potentially regulated across the spectrum 
     of programs administered by all covered agencies.
       (B) The Director shall consult with the Office of Science 
     and Technology Policy regarding the scope of the study and 
     the conduct of the comparative risk analysis.
       (2) Criteria.--In arranging for the comparative risk 
     analysis referred to in paragraph (1) of this subsection, the 
     Director shall ensure that--
       (A) the scope and specificity of the analysis are 
     sufficient to provide the President and agency heads guidance 
     in allocating resources across agencies and among programs in 
     agencies to achieve the greatest degree of risk prevention 
     and reduction for the public and private resources expended;
       (B) the analysis is conducted through an open process, by 
     individuals with relevant expertise, including toxicologists, 
     biologists, engineers and experts in medicine, industrial 
     hygiene and environmental effects;
       (C) the analysis is conducted, to the extent feasible, 
     consistent with the risk assessment and risk characterization 
     principles in sections 635 and 636 of this title;
       (D) the methodologies and principal scientific 
     determinations made in the analysis are subjected to 
     independent and external peer review consistent with section 
     635, and the conclusions of the peer review are made publicly 
     available as part of the final report required under 
     subsection (e);
       (E) there is an opportunity for public comment on the 
     results before making them final; and
       (F) the results are presented in a manner that 
     distinguishes between the scientific 

[[Page S 9814]]
     conclusions and any policy or value judgments embodied in the 
     comparisons.
       (3) Completion and review.--No later than 3 years after the 
     effective date of this Act, the comparative risk analysis 
     required under paragraph (1) shall be completed. The 
     comparative risk analysis shall be reviewed and revised at 
     least every 5 years thereafter for a minimum of 15 years 
     following the release of the first analysis. The Director 
     shall arrange for such review and revision with an accredited 
     scientific body in the same manner as provided under 
     paragraphs (1) and (2).
       (4) Study.--The study of methodologies provided under 
     paragraph (1) shall be conducted as part of the first 
     comparative risk analysis and shall be completed no later 
     than 180 days after the completion of that analysis. The goal 
     of the study shall be to develop and rigorously test methods 
     of comparative risk analysis. The study shall have sufficient 
     scope and breadth to test approaches for improving 
     comparative risk analysis and its use in setting priorities 
     for human health, safety, and environmental risk prevention 
     and reduction.
       (5) Technical guidance.-- No later than 180 days after the 
     effective date of this Act, the Director, in collaboration 
     with other heads of covered agencies shall enter into a 
     contract with the National Research Council to provide 
     technical guidance to agencies on approaches to using 
     comparative risk analysis in setting human health, safety, 
     and environmental priorities to assist agencies in complying 
     with subsection (c) of this section.
       (e) Reports and Recommendations to Congress and the 
     President.--No later than 24 months after the effective date 
     of this Act, each covered agency shall submit a report to 
     Congress and the President--
       (1) detailing how the agency has complied with subsection 
     (c) and describing the reasons for any departure from the 
     requirement to establish priorities to achieve the greatest 
     overall net reduction in risk;
       (2) recommending--
       (A) modification, repeal, or enactment of laws to reform, 
     eliminate, or enhance programs or mandates relating to human 
     health, safety, or the environment; and
       (B) modification or elimination of statutorily or 
     judicially mandated deadlines,

     that would assist the covered agency to set priorities in 
     activities to address the risks to human health, safety, or 
     the environment in a manner consistent with the requirements 
     of subsection (c)(1);
       (3) evaluating the categories of policy and value judgments 
     used in risk assessment, risk characterization, or cost-
     benefit analysis; and
       (4) discussing risk assessment research and training needs, 
     and the agency's strategy and schedule for meeting those 
     needs.
       (f) Savings Provision and Judicial Review.--
       (1) In general.--Nothing in this section shall be construed 
     to modify any statutory standard or requirement designed to 
     protect human health, safety, or the environment.
       (2) Judicial review.--Compliance or noncompliance by an 
     agency with the provisions of this section shall not be 
     subject to judicial review.
       (3) Agency analysis.--Any analysis prepared under this 
     section shall not be subject to judicial consideration 
     separate or apart from the requirement, rule, program, or law 
     to which it relates. When an action for judicial review of a 
     covered agency action is instituted, any analysis for, or 
     relating to, the action shall constitute part of the whole 
     record of agency action for the purpose of judicial review of 
     the action and shall, to the extent relevant, be considered 
     by a court in determining the legality of the covered agency 
     action.

                                 ______


                        ROTH AMENDMENT NO. 1501

  Mr. HATCH (for Mr. Roth) proposed an amendment No. 1500 proposed by 
Mr. Roth to the bill S. 343, supra; as follows:

       In lieu of the language proposed to be inserted, insert the 
     following:

     analysis.

     SEC. 635. RISK-BASED PRIORITIES.

       (a) Purposes.--The purposes of this section are to--
       (1) encourage Federal agencies engaged in regulating risks 
     to human health, safety, and the environment to achieve the 
     greatest risk reduction at the least cost practical;
       (2) promote the coordination of policies and programs to 
     reduce risks to human health, safety, and the environment; 
     and
       (3) promote open communication among Federal agencies, the 
     public, the President, and Congress regarding environmental, 
     health, and safety risks, and the prevention and management 
     of those risks.
       (b) Definitions.--For the purposes of this section:
       (1) Comparative risk analysis.--The term ``comparative risk 
     analysis'' means a process to systematically estimate, 
     compare, and rank the size and severity of risks to provide a 
     common basis for evaluating strategies for reducing or 
     preventing those risks.
       (2) Covered agency.--The term ``covered agency'' means each 
     of the following:
       (A) The Environmental Protection Agency.
       (B) The Department of Labor.
       (C) The Department of Transportation.
       (D) The Food and Drug Administration.
       (E) The Department of Energy.
       (F) The Department of the Interior.
       (G) The Department of Agriculture.
       (H) The Consumer Product Safety Commission.
       (I) The National Oceanic and Atmospheric Administration.
       (J) The United States Army Corps of Engineers.
       (K) The Nuclear Regulatory Commission.
       (3) Effect.--The term ``effect'' means a deleterious change 
     in the condition of--
       (A) a human or other living thing (including death, cancer, 
     or other chronic illness, decreased reproductive capacity, or 
     disfigurement); or
       (B) an inanimate thing important to human welfare 
     (including destruction, degeneration, the loss of intended 
     function, and increased costs for maintenance).
       (4) Irreversibility.--The term ``irreversibility'' means 
     the extent to which a return to conditions before the 
     occurrence of an effect are either very slow or will never 
     occur.
       (5) Likelihood.--The term ``likelihood'' means the 
     estimated probability that an effect will occur.
       (6) Magnitude.--The term ``magnitude'' means the number of 
     individuals or the quantity of ecological resources or other 
     resources that contribute to human welfare that are affected 
     by exposure to a stressor.
       (7) Seriousness.--The term ``seriousness'' means the 
     intensity of effect, the likelihood, the irreversibility, and 
     the magnitude.
       (c) Department and Agency Program Goals.--
       (1) Setting priorities.--In exercising authority under 
     applicable laws protecting human health, safety, or the 
     environment, the head of each covered agency should set 
     priorities and use the resources available under those laws 
     to address those risks to human health, safety, and the 
     environment that--
       (A) the covered agency determines to be the most serious; 
     and
       (B) 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 expended.
       (2) Determining the most serious risks.--In identifying the 
     greatest risks under paragraph (1) of this subsection, each 
     covered agency shall consider, at a minimum--
       (A) the likelihood, irreversibility, and severity of the 
     effect; and
       (B) the number and classes of individuals potentially 
     affected, and shall explicitly take into account the results 
     of the comparative risk analysis conducted under subsection 
     (d) of this section.
       (3) OMB review.--The covered agency's determinations of the 
     most serious risks for purposes of setting priorities shall 
     be reviewed and approved by the Director of the Office of 
     Management and Budget before submission of the covered 
     agency's annual budget requests to Congress.
       (4) Incorporating risk-based priorities into budget and 
     planning.--The head of each covered agency shall incorporate 
     the priorities identified under paragraph (1) into the agency 
     budget, strategic planning, regulatory agenda, enforcement, 
     and research activities. When submitting its budget request 
     to Congress and when announcing its regulatory agenda in the 
     Federal Register, each covered agency shall identify the 
     risks that the covered agency head has determined are the 
     most serious and can be addressed in a cost-effective manner 
     under paragraph (1), the basis for that determination, and 
     explicitly identify how the covered agency's requested budget 
     and regulatory agenda reflect those priorities.
       (5) Effective date.--This subsection shall take effect 12 
     months after the date of enactment of this Act.
       (d) Comparative Risk Analysis.--
       (1) Requirement.--(A)(i) No later than 6 months after the 
     effective date of this Act, the Director of the Office of 
     Management and Budget shall enter into appropriate 
     arrangements with an accredited scientific body--
       (I) to conduct a study of the methodologies for using 
     comparative risk to rank dissimilar human health, safety, and 
     environmental risks; and
       (II) to conduct a comparative risk analysis.
       (ii) the comparative risk analysis shall compare and rank, 
     to the extent feasible, human health, safety, and 
     environmental risks potentially regulated across the spectrum 
     of programs administered by all covered agencies.
       (B) The Director shall consult with the Office of Science 
     and Technology Policy regarding the scope of the study and 
     the conduct of the comparative risk analysis.
       (2) Criteria.--In arranging for the comparative risk 
     analysis referred to in paragraph (1) of this subsection, the 
     Director shall ensure that--
       (A) the scope and specificity of the analysis are 
     sufficient to provide the President and agency heads guidance 
     in allocating resources across agencies and among programs in 
     agencies to achieve the greatest degree of risk prevention 
     and reduction for the public and private resources expended;
       (B) the analysis is conducted through an open process, by 
     individuals with relevant expertise, including toxicologists, 
     biologists, engineers and experts in medicine, industrial 
     hygiene and environmental effects;
       (C) the analysis is conducted, to the extent feasible, 
     consistent with the risk assessment and risk characterization 
     principles in section 633 of this title;
       (D) the methodologies and principal scientific 
     determinations made in the analysis 

[[Page S 9815]]
     are subjected to independent and external peer review consistent with 
     section 633(g), and the conclusions of the peer review are 
     made publicly available as part of the final report required 
     under subsection (e);
       (E) there is an opportunity for public comment on the 
     results before making them final; and
       (F) the results are presented in a manner that 
     distinguishes between the scientific conclusions and any 
     policy or value judgments embodied in the comparisons.
       (3) Completion and review.--No later than 3 years after the 
     effective date of this Act, the comparative risk analysis 
     required under paragraph (1) shall be completed. The 
     comparative risk analysis shall be reviewed and revised at 
     least every 5 years thereafter for a minimum of 15 years 
     following the release of the first analysis. The Director 
     shall arrange for such review and revision with an accredited 
     scientific body in the same manner as provided under 
     paragraphs (1) and (2).
       (4) Study.--The study of methodologies provided under 
     paragraph (1) shall be conducted as part of the first 
     comparative risk analysis and shall be completed no later 
     than 180 days after the completion of that analysis. The goal 
     of the study shall be to develop and rigorously test methods 
     of comparative risk analysis. The study shall have sufficient 
     scope and breadth to test approaches for improving 
     comparative risk analysis and its use in setting priorities 
     for human health, safety, and environmental risk prevention 
     and reduction.
       (5) Technical guidance.--No later than 180 days after the 
     effective date of this Act, the Director, in collaboration 
     with other heads of covered agencies shall enter into a 
     contract with the National Research Council to provide 
     technical guidance to agencies on approaches to using 
     comparative risk analysis in setting human health, safety, 
     and environmental priorities to assist agencies in complying 
     with subsection (c) of this section.
       (e) Reports and Recommendations to Congress and the 
     President.--No later than 24 months after the effective date 
     of this Act, each covered agency shall submit a report to 
     Congress and the President--
       (1) detailing how the agency has complied with subsection 
     (c) and describing the reasons for any departure from the 
     requirement to establish priorities to achieve the greatest 
     overall net reduction in risk;
       (2) recommending--
       (A) modification, repeal, or enactment of laws to reform, 
     eliminate, or enhance programs or mandates relating to human 
     health, safety, or the environment; and
       (B) modification or elimination of statutorily or 
     judicially mandated deadlines,

     that would assist the covered agency to set priorities in 
     activities to address the risks to human health, safety, or 
     the environment in a manner consistent with the requirements 
     of subsection (c)(1);
       (3) evaluating the categories of policy and value judgments 
     used in risk assessment, risk characterization, or cost-
     benefit analysis; and
       (4) discussing risk assessment research and training needs, 
     and the agency's strategy and schedule for meeting those 
     needs.
       (f) Savings Provision and Judicial Review.--
       (1) In general.--Nothing in this section shall be construed 
     to modify any statutory standard or requirement designed to 
     protect human health, safety, or the environment.
       (2) Judicial review.--Compliance or noncompliance by an 
     agency with the provisions of this section shall not be 
     subject to judicial review.
       (3) Agency analysis.--Any analysis prepared under this 
     section shall not be subject to judicial consideration 
     separate or apart from the requirement, rule, program, or law 
     to which it relates. When an action for judicial review of a 
     covered agency action is instituted, any analysis for, or 
     relating to, the action shall constitute part of the whole 
     record of agency action for the purpose of judicial review of 
     the action and shall, to the extent relevant, be considered 
     by a court in determining the legality of the covered agency 
     action.

                                 ______


              DASCHLE (AND LAUTENBERG) AMENDMENT NO. 1502

  Mr. DASCHLE (for himself and Mr. Lautenberg) proposed an amendment to 
amendment No. 1487 proposed by Mr. Dole to the bill S. 343, supra; as 
follows:

       On page 19, line 5, strike out ``or''.
       On page 19, line 7, strike out the period and insert in 
     lieu thereof a semicolon and ``or''.
       On page 19, add after line 7 the following new 
     subparagraph:
       ``(xiii) the rule proposed by the United States Department 
     of Agriculture on February 3, 1995, entitled `Pathogen 
     Reduction: Hazard Analysis and Critical Control Point (HACCP) 
     Systems' (proposed rule, 60 Fed. Reg. 6774, et al.).''.
                                 ______


                JOHNSTON (AND OTHERS) AMENDMENT NO. 1503

  Mr. JOHNSTON (for himself, Mr. Hatch, and Mr. Roth) proposed an 
amendment to amendment No. 1502 proposed by Mr. Daschle to the bill S. 
343, supra; as follows:

       In lieu of the language proposed on page 1, lines 5 through 
     9, insert the following:
       ``(10) Notwithstanding section 632, if the agency head 
     determines that--
       (A) a final major rule subject to this subchapter is 
     substantially similar to the proposed major rule with respect 
     to the risk being addressed;
       (B) a risk assessment for the proposed major rule has been 
     carried out in substantial accordance with section 633; and
       (C) a new risk assessment for the final rule is not 
     required in order to respond to comments received during the 
     period for comment on the proposed rule; the head of the 
     agency may publish such determination along with the final 
     rule in lieu of preparing a new risk assessment for the final 
     rule.
       (11) Notwithstanding any provision of the Comprehensive 
     Regulatory Reform Act of 1995 and the amendments made by such 
     Act, including section 9 of such Act, any rule for which a 
     notice of proposed rulemaking was filed before April 1, 1995 
     shall not be subject to the provision of this subchapter or 
     subchapter III except for section 623 (relating to review of 
     rules).''.
                                 ______


                JOHNSTON (AND OTHERS) AMENDMENT NO. 1504

  Mr. JOHNSTON (for himself, Mr. Hatch, and Mr. Roth) proposed an 
amendment to amendment No. 1487 proposed by Mr. Dole to the bill S. 
343, supra; as follows:

       On page 50, between lines 15 and 16, insert the following 
     new paragraph:
       ``(4) If the agency head determines that--
       (A) a final major rule subject to this subchapter is 
     substantially similar to the proposed major rule with respect 
     to the risk being addressed;
       (B) a risk assessment for the proposed major rule has been 
     carried out in substantial accordance with section 633; and
       (C) a new risk assessment for the final rule is not 
     required in order to respond to comments received during the 
     period for comment on the proposed rule;

     the head of the agency may publish such determination along 
     with the final rule in lieu of preparing a new risk 
     assessment for the final rule.''
       On page 19 strike out lines 11 through 13 and the words 
     ``than 30 days after such date of enactment),''.
       On page 20, line 9 strike out the words ``(or, in the case 
     of a notice of proposed rulemaking'' and strike out lines 10 
     through 12.
       On page 43, amend line 11 to read ``agency after the 
     effective date of this subchapter''; strike out lines 12 and 
     13; and strike out ``section 623'' on line 14.
       On page 48 amend lines 4 and 5 to read ``effective date of 
     this subchapter, the head of each''.
       On page 97 reliable subsection (b) as subsection (c) and 
     insert a new subsection (b) as follows:
       ``(b) Any rulemaking pending on July 12, 1995 for which a 
     notice of proposed rulemaking or a proposed rulemaking has 
     been published in the Federal Register before April 1, 1995 
     shall not be subject to the provisions of subchapter II or 
     subchapter III of chapter 6 of title 5 U.S. Code except for 
     section 623 (relating to review of rules).''
                                 ______


                       DASCHLE AMENDMENT NO. 1505

  Mr. DASCHLE proposed an amendment to amendment No. 1487 proposed by 
Mr. Dole to the bill S. 343, supra; as follows:

       On page 19, line 5, strike out ``or''.
       On page 19, line 7, strike out the period and insert in 
     lieu thereof a semicolon and ``or''.
       On page 19, add after line 7 the following new 
     subparagraph:
       ``(xiii) the rule proposed by the United States Department 
     of Agriculture on February 3, 1995, entitled `Pathogen 
     Reduction: Hazard Analysis and Critical Control Point (HACCP) 
     Systems' (proposed rule, 60 Fed. Reg. 6774, et al.).''.
                                 ______


                  KOHL (AND OTHERS) AMENDMENT NO. 1506

  Mr. KOHL (for himself, Mr. Daschle, Mr. Glenn, Mr. Feingold, Mr. 
Lautenberg, and Mrs. Boxer) proposed an amendment to amendment No. 1487 
proposed by Mr. Dole to the bill S. 343, supra; as follows:

       On page 19, line 5, strike out ``or''.
       On page 19, line 7, strike out the period and insert in 
     lieu thereof a semicolon and ``or''.
       On page 19, add after line 7 the following new 
     subparagraph:
       ``(xiii) any rule proposed or promulgated by the 
     Environmental Protection Agency that relates to the control 
     of microbial and disinfection byproduct risks to human health 
     in drinking water supplies.''
                                 ______


                  ROTH (AND BIDEN) AMENDMENT NO. 1507

  Mr. ROTH (for himself and Mr. Biden) proposed an amendment to 
amendment No. 1487 proposed by Mr. Dole to the bill S. 343, supra; as 
follows:

       Delete all of section 635 (page 61, line 1 through page 64, 
     line 14 and add in its place the following new section 635:

     SEC. 635. RISK-BASED PRIORITIES.

       (a) Purpose.--The purposes of this section are to--

[[Page S 9816]]

       (1) encourage Federal agencies engaged in regulating risks 
     to human health, safety, and the environment to achieve the 
     greatest risk reduction at the least cost practical;
       (2) promote the coordination of policies and programs to 
     reduce risks to human health, safety, and the environment; 
     and
       (3) promote open communication among Federal agencies, the 
     public, the President, and Congress regarding environmental, 
     health, and safety risks, and the prevention and management 
     of those risks.
       (b) Definitions.--For the purpose of this section:
       (1) Comparative risk analysis.--The term ``comparative risk 
     analysis'' means a process to systematically estimate, 
     compare, and rank the size and severity of risks to provide a 
     common basis for evaluating strategies for reducing or 
     preventing those risks.
       (2) Covered agency.--The term ``covered agency'' means each 
     of the following:
       (A) The Environmental Protection Agency.
       (B) The Department of Labor.
       (C) The Department of Transportation.
       (D) The Food and Drug Administration.
       (E) The Department of Energy.
       (F) The Department of the Interior.
       (G) The Department of Agriculture.
       (H) The Consumer Product Safety Commission.
       (I) The National Oceanic and Atmospheric Administration.
       (J) The United States Army Corps of Engineers.
       (K) The Nuclear Regulatory Commission.
       (3) Effect.--The term ``effect'' means a deleterious change 
     in the condition of--
       (A) a human or other living thing (including death, cancer, 
     or other chronic illness, decreased reproductive capacity, or 
     disfigurement); or
       (B) an inanimate thing important to human welfare 
     (including destruction, degeneration, the loss of intended 
     function, and increased costs for maintenance).
       (4) Irreversibility.--The term ``irreversi- 
     bility'' means the extent to which a return to conditions 
     before the occurrence of an effect are either very slow or 
     will never occur.
       (5) Likelihood.--The term ``likelihood'' means the 
     estimated probability that an effect will occur.
       (6) Magnitude.--The term ``magnitude'' means the number of 
     individuals or the quantity of ecological resources or other 
     resources that contribute to human welfare that are affected 
     by exposure to a stressor.
       (7) Seriousness.--The term ``seriousness'' means the 
     intensity of effect, the likelihood, the irreversibility, and 
     the magnitude.
       (c) Department and Agency Program Goals.--
       (1) Setting priorities.--In exercising authority under 
     applicable laws protecting human health, safety, or the 
     environment, the head of each covered agency should set 
     priorities and use the resources available under those laws 
     to address those risks to human health, safety, and the 
     environment that--
       (A) the covered agency determines to be the most serious; 
     and
       (B) 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 expended.
       (2) Determining the most serious risks.--In identifying the 
     greatest risks under paragraph (1) of this subsection, each 
     covered agency shall consider, at a minimum--
       (A) the likelihood, irreversibility, and severity of the 
     effect; and
       (B) the number and classes of individuals potentially 
     affected, and shall explicitly take into account the results 
     of the comparative risk analysis conducted under subsection 
     (d) of this section.
       (3) OMB review.--The covered agency's determinations of the 
     most serious risks for purposes of setting priorities shall 
     be reviewed and approved by the Director of the Office of 
     Management and Budget before submission of the covered 
     agency's annual budget requests to Congress.
       (4) Incorporating risk-based priorities into budget and 
     planning.--The head of each covered agency shall incorporate 
     the priorities identified under paragraph (1) into the agency 
     budget, strategic planning, regulatory agenda, enforcement, 
     and research activities. When submitting its budget request 
     to Congress and when announcing its regulatory agenda in the 
     Federal Register, each covered agency shall identify the 
     risks that the covered agency head has determined are the 
     most serious and can be addressed in a cost-effective manner 
     under paragraph (1), the basis for that determination, and 
     explicitly identify how the covered agency's requested budget 
     and regulatory agenda reflect those priorities.
       (5) Effective date.--This subsection shall take effect 12 
     months after the date of enactment of this Act.
       (d) Comparative Risk Analysis.--
       (1) Requirement.--(A)(i) No later than 6 months after the 
     effective date of this Act, the Director of the Office of 
     Management and Budget shall enter into appropriate 
     arrangements with an accredited scientific body--
       (I) to conduct a study of the methodologies for using 
     comparative risk to rank dissimilar human health, safety, and 
     environmental risks; and
       (II) to conduct a comparative risk analysis.
       (ii) The comparative risk analysis shall compare and rank, 
     to the extent feasible, human health, safety, and 
     environmental risks potentially regulated across the spectrum 
     of programs administered by all covered agencies.
       (B) The Director shall consult with the Office of Science 
     and Technology Policy regarding the scope of the study and 
     the conduct of the comparative risk analysis.
       (2) Criteria.--In arranging for the comparative risk 
     analysis referred to in paragraph (1) of this subsection, the 
     Director shall ensure that--
       (A) the scope and specificity of the analysis are 
     sufficient to provide the President and agency heads guidance 
     is allocating resources across agencies and among programs in 
     agencies to achieve the greatest degree of risk prevention 
     and reduction for the public and private resources expended;
       (B) the analysis is conducted through an open process, by 
     individuals with relevant expertise, including toxicologists, 
     biologists, engineers and experts in medicine, industrial 
     hygiene and environmental effects;
       (C) the analysis is conducted, to the extent feasible, 
     consistent with the risk assessment and risk characterization 
     principles in section 633 of this title;
       (D) the methodologies and principal scientific 
     determinations made in the analysis are subjected to 
     independent and external peer review consistent with section 
     633(g), and the conclusions of the peer review are made 
     publicly available as part of the final report required under 
     subsection (e);
       (E) there is an opportunity for public comment on the 
     results before making them final; and
       (F) the results are presented in a manner that 
     distinguishes between the scientific conclusions and any 
     policy or value judgments embodied in the comparisons.
       (3) Completion and review.--No later than 3 years after the 
     effective date of this Act, the comparative risk analysis 
     required under paragraph (1) shall be completed. The 
     comparative risk analysis shall be reviewed and revised at 
     least every 5 years thereafter for a minimum of 15 years 
     following the release of the first analysis. The Director 
     shall arrange for such review and revision with an accredited 
     scientific body in the same manner as provided under 
     paragraphs (1) and (2).
       (4) Study.--The study of methodologies provided under 
     paragraph (1) shall be conducted as part of the first 
     comparative risk analysis and shall be completed no later 
     than 180 days after the completion of that analysis. The goal 
     of the study shall be to develop and rigorously test methods 
     of comparative risk analysis. The study shall have sufficient 
     scope and breadth to test approaches for improving 
     comparative risk analysis and its use in setting priorities 
     for human health, safety, and environmental risk prevention 
     and reduction.
       (5) Technical guidance.--No later than 180 days after the 
     effective date of this Act, the Director, in collaboration 
     with other heads of covered agencies, shall enter into a 
     contract with the National Research Council to provide 
     technical guidance to agencies on approaches to using 
     comparative risk analysis in setting human health, safety, 
     and environmental priorities to assist agencies in complying 
     with subsection (c) of this section.
       (e) Reports and Recommendations to Congress and the 
     President.--No later than 24 months after the effective date 
     of this Act, each covered agency shall submit a report to 
     Congress and the President--
       (1) detailing how the agency has complied with subsection 
     (c) and describing the reasons for any departure from the 
     requirement to establish priorities to achieve the greatest 
     overall net reduction in risk;
       (2) recommending--
       (A) modification, repeal, or enactment of laws to reform, 
     eliminate, or enhance programs or mandates relating to human 
     health, safety, or the environment; and
       (B) modification or elimination of statutorily or 
     judicially mandated deadlines,

     that would assist the covered agency to set priorities in 
     activities to address the risks to human health, safety, or 
     the environment in a manner consistent with the requirements 
     of subsection (c)(1);
       (3) evaluating the categories of policy and value judgments 
     used in risk assessment, risk characterization, or cost-
     benefit analysis; and
       (4) discussing risk assessment research and training needs, 
     and the agency's strategy and schedule for meeting those 
     needs.
       (f) Savings Provision and Judicial Review.--
       (1) In general.--Nothing in this section shall be construed 
     to modify any statutory standard or requirement designed to 
     protect human health, safety, or the environment.
       (2) Judicial review.--Compliance or non-compliance by an 
     agency with the provisions of this section shall not be 
     subject to judicial review.
       (3) Agency analysis.--Any analysis prepared under this 
     section shall not be subject to judicial consideration 
     separate or apart from the requirement, rule, program, or law 
     to which it relates. When an action for judicial review of a 
     covered agency action is instituted, any analysis for, or 
     relating to, the action shall constitute part of the whole 
     record of agency action for the purpose of judicial review of 
     the action and shall, to the extent relevant, be considered 
     by a court in determining the legality of the covered agency 
     action.

                                 ______


                        SNOWE AMENDMENT NO. 1508

  (Ordered to lie on the table.)
  Ms. SNOWE submitted an amendment intended to be proposed by her to 

[[Page S 9817]]
  amendment No. 1487 proposed by Mr. Dole to the bill S. 343, supra; as 
follows:

       At the appropriate place in the substitute amendment, 
     insert the following new section:

     SEC.   . BOTTLED WATER STANDARDS.

       Section 410 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 349) is amended--
       (1) by striking ``Whenever'' and inserting ``(a) Except as 
     provided in subsection (b), whenever''; and
       (2) by adding at the end thereof the following new 
     subsection:
       ``(b)(1)(A) Not later than 180 days after the Administrator 
     of the Environmental Protection Agency promulgates a national 
     primary drinking water regulation for a contaminant under 
     section 1412 of the Public Health Service Act (42 U.S.C. 
     300g-1), the Secretary, after public notice and comment, 
     shall issue a regulation under this subsection for that 
     contaminant in bottled water or make a finding that the 
     regulation is not necessary to protect the public health 
     because the contaminant is contained in water in public water 
     systems (as defined under section 1401(4) of such Act (42 
     U.S.C. 300f(4))) but not in water used for bottled drinking 
     water.
       ``(B) In the case of contaminants for which national 
     primary drinking water regulations were promulgated under 
     section 1412 of the Public Health Service Act (42 U.S.C. 
     300g-1) before the date of enactment of the Comprehensive 
     Regulatory Reform Act of 1995, the Secretary shall issue the 
     regulation or publish the finding not later than 1 year after 
     such date of enactment.
       ``(2) The regulation shall include any monitoring 
     requirements that the Secretary determines appropriate for 
     bottled water.
       ``(3) The regulation shall require the following:
       ``(A) In the case of contaminants for which a maximum 
     contaminant level is established in a na
      tional primary drinking water regulation under section 1412 
     of the Public Health Service Act (42 U.S.C. 300g-1), the 
     regulation under this subsection shall establish a maximum 
     contaminant level for the contaminant in bottled water 
     that is at least as stringent as the maximum contaminant 
     level provided in the national primary drinking water 
     regulation.
       ``(B) In the case of contaminants for which a treatment 
     technique is established in a national primary drinking water 
     regulation under section 1412 of the Public Health Service 
     Act (42 U.S.C. 300g-1), the regulation under this subsection 
     shall require that bottled water be subject to requirements 
     no less protective of the public health than those applicable 
     to water provided by public water systems using the treatment 
     technique required by the national primary drinking water 
     regulation.
       ``(4)(A) If the Secretary fails to establish a regulation 
     within the 180-day period described in paragraph (1)(A) or 
     the 1-year period described in paragraph (1)(B) (whichever is 
     applicable), the national primary drinking water regulation 
     described in subparagraph (A) or (B) of such paragraph 
     (whichever is applicable) shall be considered, as of the date 
     on which the Secretary is required to establish a regulation 
     under such paragraph, as the regulation applicable under this 
     subsection to bottled water.
       ``(B) Not later than 30 days after the end of the 180-day 
     period, or the 1-year period (whichever is applicable), 
     described in subparagraph (A) or (B) of paragraph (1), the 
     Secretary shall, with respect to a national primary drinking 
     water regulation that is considered applicable to bottled 
     water as provided in subparagraph (A), publish a notice in 
     the Federal Register that--
       ``(i) sets forth the requirements of the national primary 
     drinking water regulation, including monitoring requirements, 
     which shall be applicable to bottled water; and
       ``(ii) provides that--
       ``(I) in the case of a national primary drinking water 
     regulation promulgated after the date of enactment of the 
     Comprehensive Regulatory Reform Act of 1995, the requirements 
     shall take effect on the date on which the national primary 
     drinking water regulation for the contaminant takes effect 
     under section 1412 of the Public Health Service Act (42 
     U.S.C. 300g-1); or
       ``(II) in the case of a national primary drinking water 
     regulation promulgated before the date of enactment of the 
     Comprehensive Regulatory Reform Act of 1995, the requirements 
     shall take effect on the date that is 18 months after such 
     date of the enactment.''.
     

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