I
104TH CONGRESS
1ST SESSION
H. R. 690
To improve the use of risk assessment and cost-benefit analysis by Federal
agencies.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 25, 1995
Mr. ZIMMER introduced the following bill; which was referred to the Commit-
tee on Government Reform and Oversight and, in addition, to the Com-
mittees on Science and Commerce, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions
as fall within the jurisdiction of the committee concerned
A BILL
To improve the use of risk assessment and cost-benefit
analysis by Federal agencies.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Risk Assessment and
Cost-Benefit Analysis Act of 1995’’.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Risk assessment and cost-benefit analysis
are useful tools that serve to enhance the informa-
must be more effectively communicated from risk as-
sessors to decisionmakers and from decisionmakers
to the public.
(7) Research provides the scientific foundation
for risk assessment, yet risk assessment research is
fragmented within and across Federal agencies, com-
plicating the setting of risk assessment research pri-
orities.
(8) The risk assessment practices of Federal
agencies must be significantly improved if risk as-
sessment 
is 
to 
provide 
maximum 
utility 
to
decisionmakers.
(9) Federal agencies need to improve the degree
and timeliness with which they incorporate scientific
advances into their risk assessment methods and
guidelines.
(10) The risk assessment activities of Federal
agencies are poorly coordinated, such that risk as-
sessment procedures and outcomes within and across
Federal agencies are often incompatible.
(11) The data gaps, variability, and uncertain-
ties inherent in risk assessment are neither ade-
quately communicated by risk assessors nor clearly
recognized by decisionmakers and the public.
(12) Improving the reliability, accuracy, and va-
lidity of risk assessments will require additional re-
search to fill data gaps and improve risk assessment
methodologies, including comparative risk analysis
methodologies.
(13) Federal agencies require a more effective
mechanism to ensure scientific peer review is ade-
quately reported in risk assessments.
(14) There is a lack of broadly skilled risk as-
sessors and insufficient resources to provide multi-
disciplinary training and curricula needed for risk
assessors and decisionmakers.
(15) There is no common mechanism for col-
lecting risk data, for disseminating such data to all
relevant Federal agencies, and for updating risk as-
sessment methodologies.
SEC. 3. PURPOSES.
The purposes of this Act are the following:
(1) To establish an Office of Risk Assessment
and Cost-Benefit Analysis in each covered agency,
that will—
(A) oversee the development, periodic revi-
sion, and implementation of risk assessment
guidelines throughout the covered agency;
(B) provide for appropriate scientific peer
review of and public comment on risk assess-
ment guidelines and risk assessments through-
out the process of development and implementa-
tion;
(C) identify, prioritize, and recommend to
the head of the agency, research needed to ad-
vance the science of risk assessment; and
(D) develop risk characterization guidance
and oversee its implementation in order to com-
municate a description of the full range of risks
and uncertainties.
(2) To direct the head of each covered agency
to prioritize research and regulatory initiatives to
achieve the greatest risk reductions by—
(A) prioritizing threats to human health
and the environment according to the serious-
ness of the risk they pose; and
(B) the opportunities available to achieve
the greatest overall net reduction in those risks
with the public and private resources available.
(3) To direct the head of each covered agency
to incorporate risk-based priorities into the budget,
strategic planning, and research activities of the
agency.
SEC. 4. REQUIREMENT FOR COVERED AGENCIES.
In exercising authority under any Federal law to pro-
tect human health and the environment, the head of each
covered agency shall—
(1) conduct risk assessment and cost-benefit
analysis for all major rules protecting human health
and the environment;
(2) demonstrate that for all major rules the
benefits to human health or the environment justify
the costs;
(3) publish with each final rule an identification
of the most flexible and cost effective regulatory op-
tion and, if those options are not employed, an ex-
planation justifying why they are not employed;
(4) prioritize threats to human health, safety,
and the environment according to—
(A) the seriousness of the risk they pose;
and
(B) the opportunities available to achieve
the greatest overall net reduction in those risks
with the public and private resources available;
(5) prioritize the use of resources available to
the agency under those laws to reduce those risks in
accordance with the priorities established under
paragraph (4), including applying the priorities to
the budget, strategic planning, and research activi-
ties of the agency; and
(6) apply peer review to each risk assessment
and each cost-benefit analysis that may have a sig-
nificant impact on that exercise of authority.
SEC. 5. ESTABLISHMENT OF OFFICE OF RISK ASSESSMENT
AND COST BENEFIT ANALYSIS IN EACH COV-
ERED AGENCY.
(a) ESTABLISHMENT.—There is established in each
covered agency an Office of Risk Assessment and Cost-
Benefit Analysis.
(b) DIRECTOR, GENERALLY.—There shall be at the
head of the Office of each covered agency a Deputy Assist-
ant Secretary or Deputy Assistant Administrator (as spec-
ified by the head of the covered agency), who shall be ap-
pointed by the head of the covered agency from among
individuals having appropriate expertise in risk assess-
ment.
(c) FUNCTIONS OF THE DIRECTOR.—The head of
each covered agency, acting through the Director for the
agency, shall ensure that all risk assessments and cost
benefit analyses conducted by the agency under section
4(2) are performed in accordance with risk assessment
guidelines issued by the Director under subsection (f) and
use relevant, reliable, and reasonably obtainable data.
(d) SCIENTIFIC PEER REVIEW.—
(1) IN GENERAL.—The head of each covered
agency, acting through the Director, shall develop
and apply a process to conduct external and inde-
pendent scientific peer review, involving qualified in-
dividuals from a variety of disciplines and a bal-
anced representation of all interested persons, of all
risk assessment guidelines and risk assessments and
cost-benefit analyses required by this Act.
(2) RESPONSE OF DIRECTOR.—As part of the
peer review process, the head of a covered agency,
acting through the Director, shall provide a written
response to comments made by the persons conduct-
ing the peer review. The response shall indicate that
the Director explicitly considered the comments, the
degree to which such comments have been incor-
porated into the risk assessment guidelines or risk
assessment, as applicable, and the reason why a
comment has not been incorporated.
(3) SELECTION
OF
PEER
REVIEWERS.—The
head of each covered agency, acting through the Di-
rector, shall provide for the conduct of scientific peer
review required by this Act by one or more of the
following entities:
(A) Science advisory boards or panels es-
tablished under other existing laws.
(B) Any other person determined by the
Director to be appropriate.
(4) GRANTS, CONTRACTS, AND AGREEMENTS.—
The head of a covered agency, acting through the
Director and subject to the availability of appropria-
tions, may enter into grants, contracts, and inter-
agency or other cooperative agreements for the con-
duct of peer review under this Act.
(5) REPORTS.—Not later than 180 days after
the date of the enactment of this Act, the head of
each covered agency, acting through the Director,
shall submit to the Congress a report on a plan for
conducting scientific peer review under this Act, and
shall also report to the Congress whenever signifi-
cant modifications are made to the plan.
(e) USE OF SERVICES; CONSULTATION.—In conduct-
ing activities under this Act, the Director of a covered
agency may—
(1) use services of consultants,
(2) establish advisory boards, and
(3) to the extent practicable consult with—
(A) science advisory boards and panels es-
tablished under other laws,
(B) State and local government agencies,
(C) appropriate professional groups,
(D) appropriate representatives of indus-
try, universities, agriculture, labor, consumers,
conservation organizations, other public interest
groups and organizations, and
(E) individuals.
(f) ISSUANCE OF RISK ASSESSMENT GUIDELINES.—
(1) IN GENERAL.—The Director of each covered
agency shall develop, issue, and publish risk assess-
ment guidelines that provide consistency and tech-
nical quality among risk assessments performed by
the agency.
(2) NOTICE
AND
COMMENT.—Before issuing
guidelines under this subsection, the Director of a
covered agency shall—
(A) publish all proposed guidelines for the
purpose of seeking public comment; and
(B) publish notice of the intent to revise
existing guidelines or to develop new guidelines
and a list of the issues the Director intends to
address and upon which the Director seeks pub-
lic comment.
(3) REVIEW AND UPDATES.—The Director of a
covered agency shall review and, as necessary, up-
date guidelines issued under this subsection every 3
years.
(4) PROCEDURES FOR REVIEW OF RISK ASSESS-
MENTS.—Within 1 year after the date of the enact-
ment of this Act, the head of each covered agency
shall develop and publish procedures for the review
and revision of any risk assessment performed by
the agency. The procedures shall provide for receiv-
ing and considering new information from the public
and criteria for appropriate use of peer review and
public comment in evaluating new information.
(5) LIMITATION
ON
JUDICIAL
REVIEW.—The
development, issuance, and publication of risk as-
sessment guidelines under this subsection shall not
be subject to judicial review.
(g) USE OF GUIDELINES.—The Director of each cov-
ered agency shall oversee the use of risk assessment guide-
lines and the conduct of risk assessments by the agency.
The Director shall seek to ensure consistency in the use
of such guidelines to the extent such consistency is appro-
priate.
(h) USE OF COST-BENEFIT ANALYSIS.—The head of
each covered agency acting through the Director shall con-
duct a cost-benefit analysis before issuing any major rule.
The analysis shall include an assessment of incremental
costs and incremental risk reduction or other benefits as-
sociated with significant regulatory alternatives considered
in connection with the rule or proposed rule.
(i) RESEARCH
AND TRAINING
IN RISK ASSESS-
MENT.—
(1) EVALUATION.—The Director of each cov-
ered agency shall regularly evaluate risk assessment
research and training needs of the agency, including
the following:
(A) Research to improve model sensitivity
and otherwise reduce generic data gaps, par-
ticularly those common to multiple risk assess-
ments.
(B) Research leading to improvement of
methods to quantify and communicate uncer-
tainty and variability throughout risk assess-
ment.
(C) Emerging and future areas of re-
search, including research on comparative risk
analysis, 
exposure 
to 
multiple 
chemicals,
noncancer endpoints, biological makers of expo-
sure and effect, mechanisms of action in both
mammalian and nonmammalian species, eco-
system exposures, and prediction of ecosystem-
level response.
(D) Long-term needs to adequately train
individuals in risk assessment and risk assess-
ment application. Evaluations under this para-
graph shall include an estimate of the resources
needed to provide necessary training and rec-
ommendations on appropriate educational risk
assessment curricula.
(2) STRATEGY AND ACTIONS TO MEET IDENTI-
FIED NEEDS.—The Director shall develop a strategy,
schedule, and delegation of responsibility for carry-
ing out research and training to meet the needs
identified in paragraph (1).
(3) REPORT.—Not later than 120 days after
the date of the enactment of this Act, the head of
each covered agency shall submit to the Congress a
report on evaluations conducted under paragraph (1)
and the strategy and schedule developed under para-
graph (2). The head of each covered agency shall re-
port to the Congress whenever the evaluations, strat-
egy, and schedule are updated or modified.
SEC. 6. RISK CHARACTERIZATION.
(a) IN GENERAL.—The head of each covered agency,
acting through the Director, shall ensure that all risk
characterizations make apparent the distinction between
data and policy assumptions to facilitate interpretation
and 
appropriate 
use 
of 
the 
characterization 
by
decisionmakers.
(b) CONTENTS.—
(1) IN GENERAL.—At a minimum, risk charac-
terizations shall contain the following:
(A) Relevant information on data selection
and rejection in the risk assessment, including
a specific rationale justifying the basis for the
selection.
(B) Identification of limitations and as-
sumptions, and the rationale and extent of sci-
entific support with respect to their use.
(C) A discussion of major uncertainties
and their influence upon the risk assessment.
(D) Identification of key data gaps and the
likely impact of additional data on the risk as-
sessment.
(2) REQUIREMENTS REGARDING QUANTITATIVE
ESTIMATES OF RISK.—At a minimum, a risk charac-
terization that includes quantitative estimates of risk
shall contain the following:
(A) When scientifically feasible, the range
and distribution of exposures derived from ex-
posure scenarios used in the risk assessment of
which the risk characterization is a component,