Union Calendar No. 474
103D CONGRESS
2D SESSION
H. R. 4306
[Report No. 103–857]
A BILL
To establish a comprehensive risk assessment pro-
gram within the Environmental Protection Agen-
cy, and for other purposes.
OCTOBER 7, 1994
Reported with an amendment, committed to the Commit-
tee of the Whole House on the State of the Union, and
ordered to be printed
IB
Union Calendar No. 474
103D CONGRESS
2D SESSION
H. R. 4306
[Report No. 103–857]
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
OCTOBER 7, 1994
Additional sponsors: Mr. MINGE, Mr. BARCA of Wisconsin, Mr. MCHALE, Mr.
HUGHES, Mr. BEILENSON, Ms. ESHOO, Mr. SANDERS, Mr. JOHNSON of
Georgia, Mr. INSLEE, and Mr. PORTER
OCTOBER 7, 1994
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed in italic]
[For text of introduced bill, see copy of bill as introduced on April 28, 1994]
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 rigorous and systematic
procedure for evaluating and quantifying environ-
mental hazards which may threaten human health
and ecological resources and is an important tool for
informed policy and decisionmaking.
(2) While risk assessment is important to the en-
vironmental decisionmaking process, risk assessment
alone is not a sufficient basis for environmental deci-
sionmaking, which must also ensure the consideration
of a full range of political, economic, environmental,
and social equity concerns, and societal values.
(3) 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 prior-
ities.
nism to ensure scientific peer review of risk assess-
ments.
(10) 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.
(11) There is no common mechanism for collect-
ing risk data, for disseminating such data to all rel-
evant Federal agencies, and for updating risk assess-
ment 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 and public comment on the risk assess-
ment guidelines and risk assessments throughout
the process of guideline development and imple-
mentation;
(D) identifies and conducts research needed
to advance the science of risk assessment; and
(E) develops risk characterization guidance
and oversees its implementation in order to com-
municate a scientifically sound, unbiased, and
accurate description of the full range of risks and
significant uncertainties;
(2) to establish a study of comparative risk anal-
ysis; and
(3) to direct the Office of Science and Technology
Policy, acting through the National Science Tech-
nology Council, to establish an interagency coordinat-
ing process to promote more compatible risk assess-
ment procedures across Federal agencies.
SEC. 4. ESTABLISHMENT OF RISK ASSESSMENT PROGRAM.
(a) ESTABLISHMENT.—There is established a Risk As-
sessment Program in the Environmental Protection Agency.
(b) DIRECTOR; CONDUCT OF PROGRAM.—The Admin-
istrator 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 En-
vironmental Protection Agency under the Program as pro-
vided in this Act. The Director shall be compensated at the
rate authorized for level V of the Executive Schedule in sec-
tion 5316 of title 5, United States Code.
(c) SCIENTIFIC PEER REVIEW.—
(1) IN GENERAL.—The Director shall develop a
process to conduct independent scientific peer review,
involving qualified individuals from a variety of dis-
ciplines and interests, of all risk assessment guidelines
developed by the Environmental Protection Agency.
(2) RESPONSE OF DIRECTOR.—As part of the
peer review process, the Director shall provide a writ-
ten response to comments made by the persons con-
ducting 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 guidelines, and, the reasons why a
comment has not been fully incorporated.
(3) SELECTION OF PEER REVIEWERS.—The Ad-
ministrator shall provide for the conduct of scientific
peer review required by this Act by one or more of the
following entities:
(A) The Science Advisory Board established
under the Environmental Research, Develop-
ment, and Demonstration Authorization Act of
1978.
(B) Any other appropriate science advisory
panel of the Environmental Protection Agency.
(C) Any other person, agency, or institu-
tion. The Director may award a grant to, and
enter into a contract, interagency agreement, or
cooperative agreement with, such person, agency,
or institution for the conduct of such scientific
peer review.
(4) REPORT.—Not later than 180 days after the
date of the enactment of this Act, the Administrator
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 Con-
gress whenever significant modifications are made to
the plan.
(d) ADVICE TO THE ADMINISTRATOR.—The Director
shall regularly provide to the Administrator advice and rec-
ommendations on the conduct of risk assessment, research
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 Advisory
Board established under the Environmental Research, De-
velopment, and Demonstration Authorization Act of 1978,
State and local government agencies, appropriate profes-
sional groups, and such representatives (with expertise in
risk assessment) of industry, universities, agriculture, labor,
consumers, conservation organizations, and other public in-
terest groups, organizations, and individuals as appro-
priate.
(f) GUIDELINE DEVELOPMENT.—
(1) DEVELOPMENT.—
(A) IN GENERAL.—The Director shall regu-
larly and systematically develop and issue,
through publication in the Federal Register, risk
assessment guidelines that seek to provide con-
sistency and technical quality and ensure that
risk assessments conducted by the Agency shall be
scientifically objective and unbiased and that
significant uncertainties regarding facts, sci-
entific knowledge, and the validity of analytical
techniques, or numerical risk estimates are clear-
ly disclosed in terms readily understandable to
the public. The guidelines shall ensure that risk
assessments performed by the Agency make use of
the best information and the most plausible and
unbiased assumptions, given the scientific infor-
mation available to the Administrator.
or (B) that departure is for a specific risk assessment
and is approved in writing by the Director. The Di-
rector shall seek appropriate scientific peer review of
any such departure. Any such departure shall seek to
ensure the consistency referred to in subsection (g)(1)
and shall be included in any public record of the spe-
cific risk assessment for which the departure was
made together with the justification for why that de-
parture was made.
(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 all such
risk characterizations are as complete as practicable
to make apparent the distinction between data and
policy assumptions and to facilitate accurate inter-
pretation and appropriate use of the assessment by
decisionmakers and interested persons. The Director
shall oversee the use of such guidance within the
Agency to ensure that all such risk characterizations
distinguish human health risks from ecological and
other risks. The Environmental Protection Agency