I
103D CONGRESS
2D SESSION
H. R. 4306
To establish a comprehensive risk assessment program within the
Environmental Protection Agency, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
APRIL 28, 1994
Mr. KLEIN (for himself, Mr. ZIMMER, Mr. BROWN of California, Mr. STUDDS,
Mrs. LLOYD, Mr. SYNAR, Mr. STENHOLM, Mr. VALENTINE, Mrs.
MORELLA, Mr. PALLONE, Mr. ROEMER, Mr. SWETT, Mr. DEAL, Ms.
EDDIE BERNICE JOHNSON of Texas, Mrs. THURMAN, and Mr. BOEH-
LERT) introduced the following bill; which was referred to the Committee
on Science, Space, and Technology
A BILL
To establish a comprehensive risk assessment program within
the Environmental Protection Agency, and for other
purposes.
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 Im-
provement Act of 1994’’.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Risk assessment is a scientific procedure for
evaluating and quantifying the magnitude and sever-
ity of environmental hazards which may threaten
human health and ecological resources and is an im-
portant tool for informed policy and decisionmaking.
(2) Research provides the scientific foundation
for risk assessment, yet risk assessment research is
fragmented within and across the Environmental
Protection Agency and the Federal agencies, com-
plicating the setting of risk assessment research pri-
orities.
(3) The risk assessment practices of the Envi-
ronmental Protection Agency and other Federal
agencies must be significantly improved if risk as-
sessment 
is 
to 
provide 
maximum 
utility 
to
decisionmakers.
(4) The Environmental Protection Agency and
other Federal agencies need to improve the degree
and timeliness with which they incorporate scientific
advances into their risk assessment methods and
guidelines.
(5) The risk assessment activities of the Envi-
ronmental Protection Agency and other Federal
agencies are poorly coordinated, such that risk as-
sessment procedures and outcomes within and across
Federal agencies are often incompatible.
(6) The data gaps, variability, and uncertainties
inherent in risk assessments are neither adequately
communicated by risk assessors nor clearly recog-
nized by decisionmakers and the public.
(7) Improving the reliability, accuracy, and va-
lidity of risk assessments will require additional re-
search to fill data gaps and to improve risk assess-
ment methodologies, including comparative risk
analysis methodologies.
(8) The Environmental Protection Agency and
other Federal agencies require a more effective
mechanism to ensure scientific peer review of risk
assessments.
(9) There is a lack of broadly skilled risk asses-
sors and insufficient resources to provide multidisci-
plinary training and curricula needed for risk asses-
sors and decisionmakers.
(10) 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.
It is the purpose of this Act—
(1) to establish a Risk Assessment Program in
the Environmental Protection Agency that—
(A) develops and periodically revises risk
assessment guidelines within the Environmental
Protection Agency which reflect scientific ad-
vances;
(B) oversees the implementation of the
guidelines and ensures consistent application of
the guidelines throughout the Agency;
(C) provides for appropriate scientific peer
review of the risk assessment guidelines and
risk assessments;
(D) identifies and conducts research need-
ed to advance the science of risk assessment;
and
(E) develops risk characterization guidance
and oversees its implementation in order to
communicate the full range of risks and uncer-
tainties;
(2) to establish a pilot program on comparative
risk analysis; and
(3) to establish an interagency coordinating
process within the Office of Science and Technology
Policy, acting through the National Science Tech-
nology Council, to promote more compatible risk as-
sessment procedures across Federal agencies.
SEC. 4. ESTABLISHMENT OF RISK ASSESSMENT PROGRAM.
(a) ESTABLISHMENT.—There is established a Risk
Assessment Program in the Environmental Protection
Agency.
(b) DIRECTOR; CONDUCT OF PROGRAM.—The Ad-
ministrator shall appoint a Director of the Program, who
has appropriate expertise in risk assessment, and acting
through the Director, shall conduct the activities of the
Environmental Protection Agency under the Program as
provided in this Act.
(c) SCIENTIFIC PEER REVIEW.—The Director shall
develop a process to conduct scientific peer review of all
risk assessment guidelines developed by the Environ-
mental Protection Agency. The Director shall ensure that
the guidelines provide for an independent scientific peer
review process for risk assessment activities that contrib-
utes to the quality and objectivity of risk assessment. The
Director may award grants and enter into contracts for
the conduct of scientific peer review. Not later than 120
days after the date of the enactment of this Act, the Ad-
ministrator shall submit to the Congress a report on a
plan for conducting scientific peer review described in this
subsection. The Administrator shall report to the Congress
whenever significant modifications are made to the plan.
(d) ADVICE TO THE ADMINISTRATOR.—The Director
shall regularly provide to the Administrator advice and
recommendations on the conduct of risk assessment, re-
search needs, and the development of risk assessment
guidelines within the Environmental Protection Agency.
(e) USE OF SERVICES; CONSULTATION.—In conduct-
ing activities under the Program, the Director may use
the services of consultants, establish advisory boards, and,
to the extent practicable, consult with the Science Advi-
sory Board established under the Environmental Re-
search, Development, and Demonstration Authorization
Act of 1978, State and local government agencies, appro-
priate professional groups, and such representatives (with
expertise in risk assessment) of industry, universities, ag-
riculture, labor, consumers, conservation organizations,
and other public interest groups, organizations, and indi-
viduals as appropriate.
(f) GUIDELINE DEVELOPMENT.—
(1) IN GENERAL.—The Director shall regularly
and systematically develop, issue, and, not less than
every 3 years for each guideline, review the need to
update risk assessment guidelines consistent with
the requirements of paragraph (2) that establish
methods for conducting scientifically sound risk as-
sessments. Whenever the Director determines that
there has been a significant scientific advancement
which warrants the updating of a guideline or that
a specific risk assessment need has arisen which is
not addressed by a guideline, the Director, after ap-
propriate scientific peer review, shall provide interim
guidance on the use of the guidelines and the con-
duct of the risk assessments.
(2) CONTENTS.—The risk assessment guide-
lines shall include the following:
(A) An explanation of the scope and appli-
cability of the guidelines, including appropriate
limitations or restrictions on their use, and an
identification of appropriate Offices at the En-
vironmental Protection Agency to contact for
further information on risk assessment.
(B) Criteria for accepting and evaluating
data, and a complete description of any mathe-
matical models or other assumptions used in
the risk assessment.
(C) Criteria for selecting default options
based upon explicitly stated science policy
choices and consideration of relevant scientific
information. The guidelines should set forth the
justification and validation for the default op-
tions, and provide criteria for departing from or
substituting any such default option.
(D) An evaluation of the technical jus-
tification and the degree of conservatism each
default option imposes upon the risk assess-
ment.
(E) Criteria for using iterative or tiered
approaches to the risk assessment, with increas-
ing levels of effort and data requirements based
on the need for accuracy of the risk estimate.
(F) Criteria for conducting formal uncer-
tainty analysis during the course of the risk as-
sessment, and an explanation of the data needs
for such analysis.
(G) Criteria for risk characterization in
order to facilitate accurate interpretation and
appropriate 
use 
of 
the 
assessment 
by
decisionmakers.
(H) Effective methods for reporting risk
assessment, including formats which clearly
identify and distinguish sources of uncertainty
and variability in the risk assessment.
(3) REPORT.—Not later than 180 days after
the date of the enactment of this Act, the Adminis-
trator shall submit to the Congress a report on risk
assessment guidelines which the Environmental Pro-
tection Agency has developed, issued, and updated
and on the schedule within the Environmental Pro-
tection Agency for reviewing the guidelines. The Ad-
ministrator shall report to the Congress whenever
the guidelines are updated.
(g) USE OF GUIDELINES.—
(1) IN GENERAL.—The Director shall oversee
the use of risk assessment guidelines by the Pro-
gram and Regional Offices of the Environmental
Protection Agency in the conduct of any risk assess-
ments that may be conducted by the Environmental
Protection Agency. The Director shall seek to ensure
consistency in the use of such guidelines, to the ex-
tent such consistency is appropriate in application to
various environmental media or environmental haz-
ards. The Director shall supervise the use of such
guidelines within the Environmental Protection
Agency to ensure that risk assessment is, to the ex-
tent permitted by law, conducted, applied, and prac-
ticed throughout the Offices of the Agency in ac-
cordance with the guidelines and that advances
made in one area of risk assessment are applied as
appropriate within the Agency to other areas of risk
assessment.
(2) DEPARTURES FROM GUIDELINES.—A Pro-
gram or Regional Office of the Environmental Pro-
tection Agency may not depart from a guideline un-
less the departure is consistent with guidance pro-
vided by the Director under subsection (f)(1). Any
interested person may petition the Director for re-
view of a decision by a Program or Regional Office
to depart from a guideline. Within 120 days after
receiving the petition, the Director shall, using ap-
propriate scientific peer review, review the decision
to determine whether the departure was warranted
and whether to issue interim guidance under sub-
section (f)(1).
(h) RISK CHARACTERIZATION.—
(1) IN GENERAL.—The Director shall regularly
and systematically develop, issue, and update guid-
ance within the Environmental Protection Agency
for any risk characterizations that may be conducted
by the Agency. The Director shall oversee the use of
such guidance within the Agency to ensure that any
such risk characterizations are complete and provide
for informed evaluation and use of risk assessment.
(2) CONTENTS.—The guidance shall include
guidance on the following:
(A) Relevant information on data and as-
sessment methods that significantly influence
the risk estimate.
(B) Limitations, assumptions, and default
options included in the assessment and the ra-
tionale and extent of scientific consensus with
respect to their use.
(C) A statement that identifies major un-
certainties and their influence upon the assess-
ment. The statement shall characterize uncer-
tainties associated with experimental measure-
ment errors and uncertainties associated with
the choice of specific models and default op-
tions.
(D) The ranges of exposures derived from
exposure 
scenarios, 
their 
estimated 
prob-
abilities.
(E) The use of both quantitative and quali-
tative descriptors to present the full range of
risks encountered by the various populations
and individuals in a human health risk assess-
ment, or by the various species and ecological
communities in an ecological risk assessment,
exposed to the environmental hazard being eval-
uated in the risk assessment.
(F) A description of all appropriate statis-
tical expressions of the range and variability of
the risk estimate.
(3) REPORT.—Not later than 180 days after
the date of the enactment of this Act, the Adminis-
trator shall submit to the Congress a report on risk
characterization guidance developed, issued, and up-
dated under this subsection. The Administrator shall
report to the Congress whenever risk characteriza-
tion guidance under this subsection is updated.
(i) RISK COMMUNICATION.—The Director shall pro-
mote open dialogue among scientists, decisionmakers, and
the public in order to improve the use of risk assessments
by decisionmakers and to accurately, objectively, and
clearly communicate risk characterizations.
(j) RESEARCH
AND TRAINING
IN RISK ASSESS-
MENT.—
(1) EVALUATION.—The Director shall regularly
and systematically evaluate risk assessment research
and training needs of the Environmental Protection
Agency, including the following needs:
(A) Research with respect to data gaps,
modeling needs, and validation of default op-
tions, particularly those common to multiple
risk assessments.
(B) Research to examine the causes and
extent of variability within and among individ-
uals, species, populations, and, in the case of
ecological risk assessment, ecological commu-
nities.
(C) Research leading to the improvement
of methods to quantify and communicate uncer-
tainty and variability throughout the risk as-
sessment, and risk assessment reporting meth-
ods that clearly distinguish between uncertainty
and variability.
(D) Emerging and future areas of re-
search, including research on comparative risk
analysis, exposure to multiple chemicals and
other stressors, noncancer endpoints, mecha-
nisms of action in both mammalian and non-
mammalian species, and prediction of eco-
system-level responses.
(E) Long-term needs to adequately train
individuals in risk assessment and risk assess-
ment applications. An evaluation under this
paragraph shall include an estimate of the re-
sources needed to provide necessary training
and recommendations on appropriate edu-
cational risk assessment curricula.
(2) DEVELOPMENT OF STRATEGY.—The Direc-
tor shall develop a strategy, schedule, and delegation
of responsibility for carrying out research and train-
ing 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 Adminis-
trator shall submit to the Congress a report on the
evaluations conducted under paragraph (1) and the
strategy and schedule developed under paragraph
(2). The Administrator shall report to the Congress
whenever the evaluations, strategy, and schedule are
updated or modified.
SEC. 5. PILOT PROJECT ON COMPARATIVE RISK ANALYSIS.
(a) IN GENERAL.—As part of the Program, the Di-
rector shall conduct, or provide for the conduct of, a pilot
project using comparative risk analysis to rank dissimilar
environmental risks and to provide a common basis for
evaluating strategies for reducing or preventing those
risks. The goal of the pilot project shall be to develop and
test methods of comparative risk analysis which produce
results that are replicable, testable, and objective.
(b) SCOPE OF PROJECT.—The pilot project shall have
sufficient scope and breadth to rigorously and scientif-
ically test the feasibility and utility of employing compara-
tive risk analysis. The pilot project shall compare and rank
a range of diverse environmental risks, both as to risks
to and within an environmental medium and risks across
environmental media. The project shall draw on appro-
priate social science literature in formulating methods of
comparative risk analysis.
(c) PROJECT PARTICIPANTS.—In conducting the
pilot project, the Director shall provide for the participa-
tion of a range of individuals with varying backgrounds
and expertise, both technical and nontechnical, comprising
broad representation of the public and private sectors.
(d) DURATION.—The pilot project shall begin within
180 days after the date of the enactment of this Act and
terminate within 2 years after the date on which it began.
(e) EVALUATION OF USE OF COMPARATIVE RISK
ANALYSIS.—Not later than 90 days after the termination
of the pilot project, the Director shall submit to the Ad-
ministrator a report that evaluates the results of the pilot
project and that has been subject to scientific peer review.
Not later than 30 days after receiving the report from the
Director, the Administrator shall forward the report to the
Congress with the results of the scientific peer review and
recommendations regarding the advantages, disadvan-
tages, and practical utility of using comparative risk anal-
ysis for decisionmaking in the Environmental Protection
Agency.
SEC. 6. INTERAGENCY COORDINATION.
To promote the conduct, application, and practice of
risk assessment in a consistent manner under Federal law
and with respect to different environmental media, and to
identify risk assessment data and research needs common
to more than one Federal agency, the Director of the Of-
fice of Science and Technology Policy shall—
(1) periodically survey the manner in which
each Federal agency involved in risk assessment is
conducting such risk assessment to determine the
scope and adequacy of risk assessment practices in
use by the Federal Government;
(2) provide advice and recommendations to the
President based on the surveys conducted and deter-
minations made under paragraph (1);
(3) establish appropriate interagency mecha-
nisms to promote coordination among Federal agen-
cies conducting risk assessment with respect to the
conduct, application, and practice of risk assessment
and to promote the use of state-of-the-art risk as-
sessment practices throughout the Federal Govern-
ment; and
(4) establish appropriate mechanisms between
Federal and State agencies to communicate state-of-
the-art risk assessment practices.
SEC. 7. SAVINGS PROVISION.
Nothing in this Act shall be construed to modify any
requirement or standard provided for in another provision
of law that provides for risk assessment or is designed to
protect health, safety, or the environment. Nothing in this
Act shall be construed to require the conduct of a risk
assessment or a risk characterization by the Environ-
mental Protection Agency that is not required by law.
SEC. 8. DEFINITIONS.
For purposes of this Act:
(1) The term ‘‘Administrator’’ means the Ad-
ministrator of the Environmental Protection Agency.
(2) The term ‘‘comparative risk analysis’’
means a process to systematically measure, compare,
and rank the severity of environmental risks in order
to provide a common basis for evaluating strategies
for reducing or preventing those risks.
(3) The term ‘‘default option’’ means a condi-
tion, assumption, or fact that is presumed unless in-
formation is available which justifies an alternative.
(4) The term ‘‘Director’’ means the Director of
the Risk Assessment Program established in section
4.
(5) The term ‘‘environmental hazard’’ means
any physical, chemical, or biological agent, or a situ-
ation or circumstance presented through an environ-
mental medium, which may impose an adverse effect
upon human health or ecological resources.
(6) The term ‘‘environmental medium’’ means
the natural occurrence of air, water, soil, or bio-
logically-derived material, or any combination or
process thereof.
(7) The term ‘‘risk assessment’’ means a rigor-
ous and systematic characterization of the potential
adverse health or ecological effects of exposure of
human or nonhuman species to environmental haz-
ards.
(8) The term ‘‘risk assessment guideline’’
means a peer-reviewed document of a Federal agen-
cy that contains methodological recommendations
pertaining to the practice or application of risk as-
sessment.
(9) The term ‘‘risk characterization’’ means the
characterization of a risk, based on a risk assess-
ment, that quantitatively and qualitatively describes
the probability and severity of that risk in terms of
the population exposed to the risk and the types of
potential effects of the exposure and that explicitly
states the range, variability, and attendant uncer-
tainty of that risk.
(10) The term ‘‘scientific peer review’’ means
the process of objectively evaluating the technical ac-
curacy, validity, and clarity of a risk assessment by
an impartial group of technically qualified individ-
uals.
(11) The term ‘‘uncertainty analysis’’ means
the systematic process of identifying that which is
not known or defined, including measurement errors,
as well as the lack of fundamental knowledge needed
to choose among alternative hypotheses, assump-
tions, or experimental models.
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HR 4306 IH——2