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103D CONGRESS
1ST SESSION
H. R. 2910
To more fully and accurately inform the public concerning health, safety,
and environmental risks, to improve consistency in the presentation of
scientific information, and to enhance the scientific credibility of the
regulatory decisions of the Environmental Protection Agency.
IN THE HOUSE OF REPRESENTATIVES
AUGUST 6, 1993
Mr. MOORHEAD (for himself, Mr. BROWN of California, Mr. BLILEY, Mr.
OXLEY, Mr. HAYES, Mrs. LLOYD, Mr. WALKER, and MR. ZIMMER) intro-
duced the following bill; which was referred jointly to the Committees on
Science, Space, and Technology and Energy and Commerce
A BILL
To more fully and accurately inform the public concerning
health, safety, and environmental risks, to improve con-
sistency in the presentation of scientific information, and
to enhance the scientific credibility of the regulatory
decisions of the Environmental Protection Agency.
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 Communication
Act of 1993’’.
SEC. 2. PURPOSES.
The purposes of this Act are—
(1) to present the public and Environmental
Protection Agency officials with the most scientif-
ically objective information concerning the nature
and magnitude of health, safety, and environmental
risks in order to provide for sound regulatory deci-
sions and public education;
(2) to provide for full consideration and discus-
sion of relevant data and potential methodologies;
(3) to require explanation of significant choices
in the risk assessment process which will allow for
better peer review and public understanding; and
(4) to improve consistency within the Environ-
mental Protection Agency in preparing risk assess-
ments and risk characterizations.
SEC. 3. EFFECTIVE DATE; APPLICABILITY; SAVINGS PROVI-
SIONS.
(a) EFFECTIVE DATE.—Except as otherwise specifi-
cally provided in this Act, the provisions of this Act shall
take effect 2 years after the date of enactment of this Act.
(b) APPLICABILITY.—(1) Except as provided in para-
graph (2), this Act applies to all risk assessments and risk
characterizations prepared by or on behalf of the Environ-
mental Protection Agency in connection with health, safe-
ty, and environmental risks.
(2) This Act does not apply to risk assessments or
risk characterizations performed with respect to a situa-
tion that the Administrator considers to be an emergency.
(c) SAVINGS PROVISIONS.—Nothing in this Act shall
be construed to modify any statutory standard or require-
ment designed to protect health, safety, or the environ-
ment.
SEC. 4. PRINCIPLES FOR RISK ASSESSMENT.
(a) IN GENERAL.—The Administrator of the Envi-
ronmental Protection Agency shall apply the principles set
forth in subsection (b) when preparing risk assessments
in order to assure that such risk assessments and all of
their components are, to the maximum extent possible, sci-
entifically objective and inclusive of all relevant data. Dis-
cussions or explanations required under this section need
not be repeated in each risk assessment document as long
as there is a reference to the relevant discussion or expla-
nation in another agency document.
(b) PRINCIPLES.—The principles to be applied when
preparing risk assessments are the following:
(1) The Administrator shall explicitly distin-
guish scientific findings in risk assessments from
other considerations affecting the design and choice
of regulatory strategies.
(2) The Administrator shall consider and dis-
cuss both negative and positive laboratory or epide-
miological data of sufficient quality when presenting
assessments of human health risks. Where conflicts
among such data appear to exist, the assessment
shall include discussion of possible reconciliation of
conflicting information, which may include dif-
ferences in study designs, comparative physiology,
routes of exposure, bioavailability, pharmacokinetics,
and any other relevant factor.
(3) Where the risk assessment process involves
selection of any significant assumption, inference, or
model the Administrator shall (A) present a rep-
resentative list and explanation of plausible and al-
ternative assumptions, inferences, or models; (B) ex-
plain the basis for any choices; and (C) identify any
policy or value judgments. The Administrator shall
also indicate the extent to which any significant
model has been validated by or conflicts with empiri-
cal data.
SEC. 5. PRINCIPLES FOR RISK CHARACTERIZATION.
In characterizing risk in any risk assessment docu-
ment, regulatory proposal or decision, report to Congress,
or other document which is made available to the public,
the Administrator shall comply with each of the following:
(1) The Administrator shall characterize the
populations or natural resources at risk. If a numer-
ical estimate of risk is provided, the departments
and agencies shall, to the extent feasible, provide the
best estimate or estimates for the populations or
natural resources at risk, given the information
available to the Administrator, along with a state-
ment of the reasonable range of scientific uncer-
tainty. In addition to the best estimate, the Adminis-
trator may present plausible upper-bound or con-
servative estimates in conjunction with plausible
lower bounds estimates. Where appropriate, the Ad-
ministrator may present, in lieu of a single best esti-
mate, multiple estimates based on assumptions, in-
ferences, or models which are equally plausible,
given current scientific understanding.
(2) The Administrator shall explain the range
of exposure scenarios used in any risk assessment,
and, to the extent feasible, provide a statement of
the size of the corresponding population at risk and
the likelihood of such exposure scenarios.
(3) To the extent feasible, the Administrator
shall provide appropriate comparisons with estimates
of other risks, including those that are familiar to
and routinely encountered by the general public.
(4) When the Administrator provides a risk as-
sessment or risk characterization for proposed and
final regulatory actions, such assessment or charac-
terization shall include a statement of any known
and significant substitution risks.
(5) In any case in which the Administrator pro-
vides a public comment period with respect to a risk
assessment or regulation, and a commenter provides
a risk assessment and summary of results that is
consistent with the principles and the guidance pro-
vided under this Act, the Administrator shall present
the summary of results of such risk assessment in
connection with the presentation of the Environ-
mental Protection Agency’s risk assessment (if any)
or regulation.
SEC. 6. GUIDANCE, PLAN FOR ASSESSING NEW INFORMA-
TION, AND REPORT.
(a) GUIDANCE.—Within 18 months after the date of
enactment of this Act, the Administrator shall issue guid-
ance consistent with the risk assessment and characteriza-
tion principles stated in sections 4 and 5 and shall provide
a format for summarizing risk assessment results.
(b) ADDITIONAL SUBJECTS ADDRESSED.—In addi-
tion to including the principles set forth in sections 4 and
5, the guidance issued under this section shall include
guidance on at least the following subjects: interspecies
scaling factors; use of different types of dose-response
models; thresholds; definitions, use, and interpretations of
the maximum tolerated dose; weighting of positive and
negative findings from sensitive species; evaluation of be-
nign tumors, and evaluation of different health endpoints.
(c) PLAN.—Within 2 years after the date of enact-
ment of this Act, the Administrator shall publish a plan
to review and revise any risk assessment with respect to
which the Environmental Protection Agency determines
there is significant new information or methodologies
available that could significantly alter the prior results of
the risk assessment. The plan shall provide procedures for
receiving and considering new information and risk assess-
ments from the public. The plan may set priorities for re-
view and revision of risk assessments based on factors the
Administrator considers appropriate.
(d) REPORT.—Within 3 years after the enactment of
this Act, the Administrator shall provide a report to the
Congress evaluating the policy and value judgments of the
type identified under paragraph (3) of section 4 which are
made by the Administrator in risk assessments performed
for programs under the Toxic Substances Control Act and
the effect these judgments have on the regulatory deci-
sions of such programs.
(e) PUBLIC COMMENT
AND CONSULTATION.—The
guidance, plan and report under this section, shall be de-
veloped after notice and opportunity for public comment
and in consultation with the EPA Science Advisory Board,
representatives of appropriate State agencies, and such
other departments and agencies, offices, organizations, or
persons as the Administrator considers advisable.
(f) REVIEW.—Guidance promulgated under this sec-
tion shall be reviewed by the Administrator at least every
4 years in accordance with subsection (d).
SEC. 7. DEFINITIONS.
For purposes of this Act:
(1) The term ‘‘risk assessment’’ means the
process of identifying hazards and quantifying or de-
scribing the degree of risk they pose for exposed in-
dividuals, populations, or resources. It also refers to
the document containing the explanation of how the
assessment process has been applied to an individual
substance, activity, or condition.
(2) The term ‘‘risk characterization’’ means
that element of a risk assessment that involves pres-
entation of the degree of risk in any regulatory pro-
posal or decision, report to Congress, or other docu-
ment which is made available to the public. The
term includes discussions of uncertainties, conflict-
ing data, estimates, extrapolations, inferences, and
opinions.
(3) The term ‘‘best estimate’’ means an esti-
mate based on (A) central estimates of risk using
the most unbiased assumptions and models, (B) an
approach which combines multiple estimates based
on different scenarios and weighs the probability of
each scenario or (C) any other methodology designed
to provide the most unbiased representation of the
most plausible level of risk, given the current sci-
entific information available to the Administrator.
(4) The term ‘‘negative data’’ means data indi-
cating that under certain conditions a given sub-
stance or activity did not induce an adverse effect.
(5) The term ‘‘substitution risk’’ means a po-
tential increased risk to human health, safety, or the
environment from a regulatory option designed to
decrease other risks.
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