[Congressional Record Volume 141, Number 112 (Wednesday, July 12, 1995)]
[Senate]
[Pages S9733-S9738]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  COMPREHENSIVE REGULATORY REFORM ACT

  The PRESIDING OFFICER. Under the previous order the Senate will now 
resume consideration of S. 343, which the clerk will report.
  The assistant legislative clerk read as follows:

       A bill (S. 343) to reform the regulatory process and for 
     other purposes.

  The Senate resumed consideration of the bill.

       Pending:
       Dole amendment No. 1487, in the nature of a substitute.

  The PRESIDING OFFICER. The Senator from Utah is recognized.
  Mr. HATCH. Madam President, we have been debating this bill now for a 
number of days. We have made over 100 changes in the bill. We have 
tried to accommodate our friends on the other side.
  Madam President, I notice the distinguished minority leader is here, 
and I will be delighted to yield to him so he can make his remarks, and 
then I ask consent I be recognized immediately following the minority 
leader.
  The PRESIDING OFFICER. The Democratic leader is recognized.
  Mr. DASCHLE. Madam President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. WELLSTONE. Madam President, I ask unanimous consent that the 
order for the quorum call be rescinded.
  The PRESIDING OFFICER. Is there objection? Without objection, it is 
so ordered.
  Mr. WELLSTONE. Madam President, I ask unanimous consent I be able to 
speak for 10 minutes as in morning business.
  The PRESIDING OFFICER. Is there objection? Is there objection to 10 
minutes in morning business being allocated to the Senator from 
Minnesota?
  Mr. DASCHLE addressed the Chair.
  The PRESIDING OFFICER. There is objection at this time.
  The Senator from Minnesota has been recognized.
  Mr. DASCHLE. Madam President, are we still in a quorum call?
  The PRESIDING OFFICER. The quorum call has been lifted and the 
Senator from Minnesota has the floor.
  Mr. WELLSTONE. Madam President, I know the minority leader wants to 
lay down an amendment. Might I ask the minority leader if I can have 
some time right after that, in morning business?
  Mr. DASCHLE. I have no objection to that. I am sure the request of 
the Senator from Minnesota can be accommodated.
  Mr. WELLSTONE. Madam President, I ask unanimous consent, deferring to 
the minority leader, that I have 10 minutes to speak in morning 
business after he lays down the amendment.
  The PRESIDING OFFICER. Is there objection to the Senator from 
Minnesota having 10 minutes as in morning business? Is there objection?
  Mr. HATCH. Madam President, I am sorry?
  The PRESIDING OFFICER. The Senator from Minnesota asked if he can 
have 10 minutes as in morning business following the Democratic 
leader's remarks, and asked unanimous consent.
  Mr. DASCHLE. Madam President, I have been in consultation with the 
distinguished manager of the bill. I will withhold offering the 
amendment momentarily. The distinguished Senator from Utah has an 
amendment that he would like to offer.
  We are willing to accommodate the interests of the distinguished 
Senator from Utah. Perhaps, following that, the distinguished Senator 
from Minnesota can be recognized for his morning business time.
  Mr. WELLSTONE addressed the Chair.
  The PRESIDING OFFICER. The Senator from Minnesota.
  Mr. WELLSTONE. Madam President, I say to my colleagues, I would be 
more than pleased to defer to the Senator from Utah. I was hoping I 
would be able to speak. I have an engagement at 10. Does the Senator 
think I would have an opportunity to do that after he lays down the 
amendment?
  Mr. HATCH. I believe we can lay the amendment down and speak to it 
later.
  Let me first get the amendment, and I will call it up and be glad to 
accommodate the distinguished Senator.
  Mr. WELLSTONE. I thank the distinguished Senator from Utah.
  
[[Page S 9734]]



                Amendment No. 1498 to Amendment No. 1487

(Purpose: To strengthen the agency prioritization and comparative risk 
                      analysis section of S. 343)

  Mr. HATCH. Madam President, I send an amendment to the desk and ask 
for its immediate consideration.
  The PRESIDING OFFICER. The Senator from Minnesota has yielded the 
floor. The Senator from Utah sends an amendment to the desk. The clerk 
will read the amendment.
  The assistant legislative clerk read as follows:

       The Senator from Utah [Mr. Hatch] proposes an amendment 
     numbered 1498 to amendment No. 1487.

  Mr. HATCH. Madam President, I ask unanimous consent that reading of 
the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is 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 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 

[[Page S 9735]]

       (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.

  Mr. HATCH. Madam President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.


                Amendment No. 1499 to Amendment No. 1498

(Purpose: To strengthen the agency prioritization and comparative risk 
                      analysis section of S. 343)

  Mr. HATCH. Madam President, I send another amendment to the desk and 
ask for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Utah [Mr. Hatch] proposes an amendment 
     numbered 1499 to amendment No. 1498.

  Mr. HATCH. Madam President, I ask unanimous consent that reading of 
the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is 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 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 

[[Page S 9736]]
     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.
                           Amendment No. 1500

     (Purpose: To establish risk-based priorities for regulations)

  Mr. HATCH. Madam President, I send an amendment to the desk and ask 
for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Utah [Mr. Hatch], for Mr. Roth, proposes 
     an amendment numbered 1500.

  Mr. HATCH. Madam President, I ask unanimous consent that reading of 
the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is 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 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 

[[Page S 9737]]
     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.

  Mr. HATCH. Madam President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.


                Amendment No. 1501 to Amendment No. 1500

     (Purpose: To establish risk-based priorities for regulations)

  Mr. HATCH. Madam President, I send an amendment to the desk on behalf 
of Senator Roth and ask for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Utah [Mr. Hatch], for Mr. Roth, proposes 
     an amendment numbered 1501.

  Mr. HATCH. Madam President, I ask unanimous consent that reading of 
the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is 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 

[[Page S 9738]]
     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 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.

  Mr. HATCH. Madam President, I will speak to these amendments as soon 
as the distinguished Senator from Minnesota has completed. I ask 
unanimous consent I be next recognized--except for the minority leader.
  Mr. DASCHLE. Reserving the right to object, I will not object, but 
let me just indicate we are working here in good faith. We have not 
seen these amendments.
  Mr. HATCH. I have not either.
  Mr. DASCHLE. I hope we will have an opportunity, first, to look at 
the amendments; second, let me just say, I hope--I know we are working 
under the rights that every Senator is accorded under parliamentary 
procedure. But, again, we filled the tree, and I think we all 
understand the reasons for filling the tree. I hope we can have some 
good debate and have the opportunity to lay down amendments.
  I was prepared to lay an amendment down--not fill the tree--and have 
a good debate about it.
  The Senator from Utah has asked me to withdraw or delay the offering 
of that amendment. I have done so. Now I find that after I have 
conceded to do that we allow the Senator from Delaware to offer an 
amendment, and now we have not one amendment but four amendments simply 
to fill the tree.
  Mr. HATCH. Will the Senator yield?
  Mr. DASCHLE. Certainly. I am happy to yield.
  Mr. HATCH. I want to accommodate the distinguished minority leader. 
He has been so gracious this morning. We are trying to work out the 
amendment, and we will certainly do so. But we would be happy to set 
these amendments aside in favor of the amendment of the distinguished 
minority leader. So it is not a problem. We will be happy to 
accommodate the minority leader.
  Mr. DASCHLE. That is not necessary.
  I would just call attention to the fact that I think it is important 
for us to work through these things and not to deprive either side.
  Mr. HATCH. We intend to work in good faith with all Members on the 
floor, and we will do our very best to do so. As you know, this bill is 
a tough bill and there is a lot of controversy on both sides of the 
floor, although I think we are resolving those controversies. I think 
we are doing it in the ordinary course. We continue to try to resolve 
all the conflicts that might exist between our two sides. But we will 
try to cooperate with the distinguished minority leader. We want to 
move ahead on amendments today and get as much done as we can.
  Mr. GLENN. Madam President, do I understand then that the Senator 
from Utah would be amenable to setting aside what was just accomplished 
here so that the minority leader could go ahead with the amendment that 
we have prepared?
  Mr. HATCH. Sure. We will be happy to do that.
  Mr. GLENN. Madam President, further inquiry, can we have copies of 
the amendments?
  I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. HATCH. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. HATCH. I ask unanimous consent that the Senator from Minnesota be 
permitted to speak for up to 10 minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The Senator from Minnesota is recognized to speak for up to 10 
minutes.
  Mr. WELLSTONE. I thank the Chair.

                          ____________________