[Congressional Record Volume 144, Number 22 (Friday, March 6, 1998)]
[Senate]
[Pages S1527-S1529]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. LOTT:
  S. 1728. A bill to provide for the conduct of a risk assessment for 
certain Federal agency rules, and for other purposes; to the Committee 
on Governmental Affairs.


                  the risk assessment improvement act

  Mr. LOTT. Mr. President, federal bureaucrats issued thousands of new 
rules and regulations last year, adding billions to the regulatory 
costs already imposed on American businesses and the economy. Whether 
you realize it or not, almost every aspect of our daily existence is 
regulated in some way by the government.
  That is not to say that the government should not regulate when it's 
necessary to protect human health and the environment. However, we 
would all agree that there are reasonable limits to how much protection 
we really need. For instance, cars are dangerous vehicles. If not 
properly operated, they can cause serious injury or death. It is 
certainly acceptable for the government to issue regulations ensuring 
that a vehicle is able to withstand anticipated impacts. But should we 
outlaw cars simply because improper operation can lead to death? Of 
course not. We all can see that the benefits of being able to drive a 
car far outweigh any risk of death.
  Mr. President, how do we separate true risks from inflated risks? How 
do we parcel out real problems from those created by fear or 
misinformation? How do we rank risks so that we attend to the most 
pressing ones first?
  I believe that the solution is to strengthen the risk assessment 
portion of the current federal law. It is about time that federal 
agencies focused on finding solutions to problems that present real 
risks, risks that are based on sound science. For too long, agencies 
have been allowed to use scant science and political windsocks to 
determine what should be considered a risk to human health or the 
environment. From an overblown analysis of risk comes irrational and 
ineffective solutions--some even more harmful than the basic problem.
  That is why I am introducing the Risk Assessment Improvement Act.
  Before an agency can issue a rule or carry out a cost/benefit 
analysis, it must determine that there is indeed a risk. Since risk 
assessment is the first threshold for issuing regulations, I believe 
that a targeted bill like this one would address the most important 
part of regulatory reform.
  Simply put, Mr. President, this bill ensures that there is no 
ambiguity about whether or not there is a risk. By requiring rulemaking 
agencies to follow a prescribed and stringent set of evaluations, the 
bill strengthens the current method of evaluating risk. In addition, 
the Risk Assessment Improvement Act states that risks must be reviewed 
in light of other risks. In other words, it would require agencies to 
rank risks from least to most severe, guaranteeing that the most 
serious ones are addressed first. This is not only smart regulatory and 
health policy, it is smart fiscal policy. We will be better able to 
allocate federal resources if we know ahead of time which risks are 
most pressing.
  I know that Senator Thompson has done his best to assemble a 
comprehensive regulatory reform package, and I certainly commend his 
efforts. But a comprehensive approach offers many complexities, both 
substantively and procedurally. That is why I am introducing a bill to 
deal with just one element of the regulatory process--risk.
  If you take a look at the language of my bill, you will find that it 
is identical to that in the risk assessment title of the original 
Levin-Thompson bill. The reason for this is simple: their language is 
both strong and well written. And it gets the job done. I hope that I 
can count on Senators Thompson and Levin's support in moving the bill 
through the Government Affairs Committee.
  In closing, Mr. President, I ask my colleagues to join me in taking 
an incremental and doable step towards real regulatory reform by 
supporting the Risk Assessment Improvement Act.
  Mr. President. I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1728

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Federal Regulatory Risk 
     Assessment Act of 1997''.

     SEC. 2. RISK ASSESSMENTS.

       (a) In General.--Chapter 6 of title 5, United States Code, 
     is amended by adding at the end the following:

                   ``SUBCHAPTER II--RISK ASSESSMENTS

     ``Sec. 621. Definitions

       ``For purposes of this subchapter the definitions under 
     section 551 shall apply and--
       ``(1) the term `cost' means the reasonably identifiable 
     significant adverse effects, including social, health, 
     safety, environmental, economic, and distributional effects 
     that are expected to result directly or indirectly from 
     implementation of, or compliance with, a rule;
       ``(2) the term `Director' means the Director of the Office 
     of Management and Budget, acting through the Administrator of 
     the Office of Information and Regulatory Affairs;
       ``(3) the term `flexible regulatory options' means 
     regulatory options that permit flexibility to regulated 
     persons in achieving the objective of the statute as 
     addressed by the rule making, including regulatory options 
     that use market-based mechanisms, outcome oriented 
     performance-based standards, or other options that promote 
     flexibility;
       ``(4) the term `major rule' means a rule or a group of 
     closely related rules that--
       ``(A) the agency proposing the rule or the Director 
     reasonably determines is likely to have an annual effect on 
     the economy of $100,000,000 or more in reasonably 
     quantifiable costs; or
       ``(B) is otherwise designated a major rule by the Director 
     on the ground that the rule is likely to adversely affect, in 
     a material way, the economy, a sector of the economy, 
     including small business, productivity, competition, jobs, 
     the environment, public health or safety, or State, local or 
     tribal governments, or communities;
       ``(5) the term `reasonable alternative' means a reasonable 
     regulatory option that would achieve the objective of the 
     statute as addressed by the rule making and that the agency 
     has authority to adopt under the statute granting rule making 
     authority, including flexible regulatory options;
       ``(6) the term `risk assessment' means the systematic 
     process of organizing hazard and exposure assessments to 
     estimate the potential for specific harm to exposed 
     individuals, populations, or natural resources;
       ``(7) the term `rule' has the same meaning as in section 
     551(4), and shall not include--
       ``(A) a rule exempt from notice and public comment 
     procedure under section 553;
       ``(B) a rule that involves the internal revenue laws of the 
     United States, or the assessment and collection of taxes, 
     duties, or other revenue or receipts;
       ``(C) a rule of particular applicability that approves or 
     prescribes for the future rates, wages, prices, services, 
     corporate or financial structures, reorganizations, mergers, 
     acquisitions, accounting practices, or disclosures bearing on 
     any of the foregoing;
       ``(D) a rule relating to monetary policy proposed or 
     promulgated by the Board of Governors of the Federal Reserve 
     System or by the Federal Open Market Committee;
       ``(E) a rule relating to the safety or soundness of 
     federally insured depository institutions or any affiliate of 
     such an institution (as defined in section 2(k) of the Bank 
     Holding Company Act of 1956 (12 U.S.C. 1841(k)); credit 
     unions; the Federal Home Loan Banks; government-sponsored 
     housing enterprises; a Farm Credit System Institution; 
     foreign banks, and their branches, agencies, commercial 
     lending companies or representative offices that operate in 
     the United States and any affiliate of such foreign banks (as 
     those terms are defined in the International Banking Act of 
     1978 (12 U.S.C.

[[Page S1528]]

     3101)); or a rule relating to the payments system or the 
     protection of deposit insurance funds or Farm Credit 
     Insurance Fund;
       ``(F) a rule or order relating to the financial 
     responsibility, recordkeeping, or reporting of brokers and 
     dealers (including Government securities brokers and dealers) 
     or futures commission merchants, the safeguarding of investor 
     securities and funds or commodity future or options customer 
     securities and funds, the clearance and settlement of 
     securities, futures, or options transactions, or the 
     suspension of trading under the Securities Exchange Act of 
     1934 (15 U.S.C. 78a et seq.) or emergency action taken under 
     the Commodity Exchange Act (7 U.S.C. 1 et seq.), or a rule 
     relating to the protection of the Securities Investor 
     Protection Corporation, that is promulgated under the 
     Securities Investor Protection Act of 1970 (15 U.S.C. 78aaa 
     et seq.), or a rule relating to the custody of Government 
     securities by depository institutions under section 3121 or 
     9110 of title 31;
       ``(G) a rule issued by the Federal Election Commission or a 
     rule issued by the Federal Communications Commission under 
     sections 312(a)(7) and 315 of the Communications Act of 1934 
     (47 U.S.C. 312(a)(7) and 315);
       ``(H) a rule required to be promulgated at least annually 
     pursuant to statute; or
       ``(I) a rule or agency action relating to the public debt; 
     and
       ``(8) the term `substitution risk' means an increased risk 
     to health, safety, or the environment reasonably likely to 
     result from a regulatory option.

     ``Sec. 622. Applicability

       ``Except as provided in section 623(d), this subchapter 
     shall apply to all proposed and final major rules the primary 
     purpose of which is to address health, safety, or 
     environmental risk.

     ``Sec. 623. Risk assessments

       ``(a)(1) Before publishing a notice of a proposed rule 
     making for any rule, each agency shall determine whether the 
     rule is or is not a major rule covered by this subchapter.
       ``(2) The Director may designate any rule to be a major 
     rule under section 621(4)(B), if the Director--
       ``(A) makes such designation no later than 30 days after 
     the close of the comment period for the rule; and
       ``(B) publishes such determination in the Federal Register 
     together with a succinct statement of the basis for the 
     determination within 30 days after such determination.
       ``(b)(1) When an agency publishes a notice of proposed rule 
     making for a major rule to which section 624(a) applies, the 
     agency shall prepare and place in the rule making file an 
     initial risk assessment, and shall include a summary of such 
     assessment in the notice of proposed rule making.
       ``(2)(A) When the Director has published a determination 
     that a rule is a major rule to which section 624(a) applies, 
     after the publication of the notice of proposed rule making 
     for the rule, the agency shall promptly prepare and place in 
     the rule making file an initial risk assessment for the rule 
     and shall publish in the Federal Register a summary of such 
     assessment.
       ``(B) Following the issuance of an initial risk assessment 
     under subparagraph (A), the agency shall give interested 
     persons an opportunity to comment under section 553 in the 
     same manner as if the initial risk assessment had been issued 
     with the notice of proposed rule making.
       ``(c)(1) When the agency publishes a final major rule to 
     which section 624(a) applies, the agency shall also prepare 
     and place in the rule making file a final risk assessment, 
     and shall prepare a summary of the assessment.
       ``(2) Each final risk assessment shall address each of the 
     requirements for the initial risk assessment under subsection 
     (b), revised to reflect--
       ``(A) any material changes made to the proposed rule by the 
     agency after publication of the notice of proposed rule 
     making;
       ``(B) any material changes made to the risk assessment; and
       ``(C) agency consideration of significant comments received 
     regarding the proposed rule and the risk assessment.
       ``(d)(1) A major rule may be adopted without prior 
     compliance with this subchapter if--
       ``(A) the agency for good cause finds that conducting the 
     risk assessment under this subchapter is contrary to the 
     public interest due to an emergency, or an imminent threat to 
     health or safety that is likely to result in significant harm 
     to the public or the environment; and
       ``(B) the agency publishes in the Federal Register, 
     together with such finding, a succinct statement of the basis 
     for the finding.
       ``(2) If a major rule is adopted under paragraph (1), the 
     agency shall comply with this subchapter as promptly as 
     possible unless compliance would be unreasonable because the 
     rule is, or soon will be, no longer in effect.

     ``Sec. 624. Principles for risk assessments

       ``(a)(1) Subject to paragraph (2), each agency shall design 
     and conduct risk assessments in accordance with this 
     subchapter for each proposed and final major rule , or that 
     results in a significant substitution risk, in a manner that 
     promotes rational and informed risk management decisions and 
     informed public input into and understanding of the process 
     of making agency decisions.
       ``(2) If a risk assessment under this subchapter is 
     otherwise required by this section, but the agency determines 
     that--
       ``(A) a final rule subject to this subchapter is 
     substantially similar to the proposed rule with respect to 
     the risk being addressed;
       ``(B) a risk assessment for the proposed rule has been 
     carried out in a manner consistent with this subchapter; 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 agency may publish such determination along with the 
     final rule in lieu of preparing a new risk assessment for the 
     final rule.
       ``(b) Each agency shall consider in each risk assessment 
     reliable and reasonably available scientific information and 
     shall describe the basis for selecting such scientific 
     information.
       ``(c)(1) Each agency may use reasonable assumptions to the 
     extent that relevant and reliable scientific information, 
     including site-specific or substance-specific information, is 
     not reasonably available.
       ``(2) When a risk assessment involves a choice of 
     assumptions, the agency shall--
       ``(A) identify the assumption and its scientific or policy 
     basis, including the extent to which the assumption has been 
     validated by, or conflicts with, empirical data;
       ``(B) explain the basis for any choices among assumptions 
     and, where applicable, the basis for combining multiple 
     assumptions; and
       ``(C) describe reasonable alternative assumptions that were 
     considered but not selected by the agency for use in the risk 
     assessment, how such alternative assumptions would have 
     changed the conclusions of the risk assessment, and the 
     rationale for not using such alternatives.
       ``(d) Each agency shall provide appropriate opportunity for 
     public comment and participation during the development of a 
     risk assessment.
       ``(e) Each risk assessment supporting a major rule under 
     this subchapter shall include, as appropriate, each of the 
     following:
       ``(1) A description of the hazard of concern.
       ``(2) A description of the populations or natural resources 
     that are the subject of the risk assessment.
       ``(3) An explanation of the exposure scenarios used in the 
     risk assessment, including an estimate of the corresponding 
     population at risk and the likelihood of such exposure 
     scenarios.
       ``(4) A description of the nature and severity of the harm 
     that could reasonably occur as a result of exposure to the 
     hazard.
       ``(5) A description of the major uncertainties in each 
     component of the risk assessment and their influence on the 
     results of the assessment.
       ``(f) To the extent scientifically appropriate, each agency 
     shall--
       ``(1) express the overall estimate of risk as a reasonable 
     range or probability distribution that reflects 
     variabilities, uncertainties, and lack of data in the 
     analysis;
       ``(2) provide the range and distribution of risks and the 
     corresponding exposure scenarios, identifying the range and 
     distribution and likelihood of risk to the general population 
     and, as appropriate, to more highly exposed or sensitive 
     subpopulations, including the most plausible estimates of the 
     risks; and
       ``(3) where quantitative estimates are not available, 
     describe the qualitative factors influencing the range, 
     distribution, and likelihood of possible risks.
       ``(g) When scientific information that permits relevant 
     comparisons of risk is reasonably available, each agency 
     shall use the information to place the nature and magnitude 
     of a risk to health, safety, or the environment being 
     analyzed in relationship to other reasonably comparable risks 
     familiar to and routinely encountered by the general public. 
     Such comparisons should consider relevant distinctions among 
     risks, such as the voluntary or involuntary nature of risks.
       ``(h) When scientifically appropriate information on 
     significant substitution risks to health, safety, or the 
     environment is reasonably available to the agency, the agency 
     shall describe such risks in the risk assessment.

     ``Sec. 625. Deadlines for rule making

       ``(a) All deadlines in statutes or imposed by a court of 
     the United States, that require an agency to propose or 
     promulgate any major rule to which section 624(a) applies, 
     during the 2-year period beginning on the effective date of 
     this section shall be suspended until the earlier of--
       ``(1) the date on which the requirements of this subchapter 
     are satisfied; or
       ``(2) the date occurring 6 months after the date of the 
     applicable deadline.
       ``(b) In any case in which the failure to promulgate a 
     major rule to which section 624(a) applies by a deadline 
     occurring during the 2-year period beginning on the effective 
     date of this section would create an obligation to regulate 
     through individual adjudications, the deadline shall be 
     suspended until the earlier of--
       ``(1) the date on which the requirements of this subchapter 
     are satisfied; or
       ``(2) the date occurring 6 months after the date of the 
     applicable deadline.

     ``Sec. 626. Judicial review

       ``(a) Compliance or noncompliance by an agency with the 
     provisions of this subchapter shall only be subject to 
     judicial review in accordance with this section.
       ``(b) Any determination of an agency whether a rule is or 
     is not a major rule under section 621(4)(A) shall be set 
     aside by a reviewing court only upon a clear and convincing 
     showing that the determination is erroneous in light of the 
     information available to the agency at the time the agency 
     made the determination.

[[Page S1529]]

       ``(c) Any determination by the Director that a rule is a 
     major rule under section 621(4), or any failure to make such 
     determination, shall not be subject to judicial review in any 
     manner.
       ``(d) Any risk assessment required under this subchapter 
     shall not be subject to judicial review separate from review 
     of the final rule to which the assessment applies. Any risk 
     assessment shall be part of the whole rule making record for 
     purposes of judicial review of the rule and shall be 
     considered by a court in determining whether the final rule 
     is arbitrary or capricious unless the agency can demonstrate 
     that the assessment would not be material to the outcome of 
     the rule.
       ``(e) If an agency fails to perform the risk assessment, a 
     court shall remand or invalidate the rule.''.
       (b) Presidential Authority.--Nothing in this Act shall 
     limit the exercise by the President of the authority and 
     responsibility that the President otherwise possesses under 
     the Constitution and other laws of the United States with 
     respect to regulatory policies, procedures, and programs of 
     departments, agencies, and offices.
       (c) Technical and Conforming Amendments.--
       (1) Part I of title 5, United States Code, is amended by 
     striking the chapter heading and table of sections for 
     chapter 6 and inserting the following:

           ``CHAPTER 6--THE ANALYSIS OF REGULATORY FUNCTIONS

           ``SUBCHAPTER I--ANALYSIS OF REGULATORY FLEXIBILITY

``Sec.
``601. Definitions.
``602. Regulatory agenda.
``603. Initial regulatory flexibility analysis.
``604. Final regulatory flexibility analysis.
``605. Avoidance of duplicative or unnecessary analyses.
``606. Effect on other law.
``607. Preparation of analysis.
``608. Procedure for waiver or delay of completion.
``609. Procedures for gathering comments.
``610. Periodic review of rules.
``611. Judicial review.
``612. Reports and intervention rights.

                   ``SUBCHAPTER II--RISK ASSESSMENTS

``621. Definitions.
``622. Applicability.
``623. Risk assessments.
``624. Principles for risk assessments.
``625. Deadlines for rule making.
``626. Judicial review.''.
       (2) Chapter 6 of title 5, United States Code, is amended by 
     inserting immediately before section 601, the following 
     subchapter heading:

         ``SUBCHAPTER I--ANALYSIS OF REGULATORY FLEXIBILITY''.

     SEC. 3. EFFECTIVE DATE.

       Except as otherwise provided in this Act, this Act shall 
     take effect 180 days after the date of enactment of this Act, 
     but shall not apply to any agency rule for which a notice of 
     proposed rulemaking is published on or before August 1, 1997.
                                 ______