H. R. 2586—21
any estimate to more fully describe risk or provide examples of
scientific uncertainty or variability. Nothing in this subchapter
shall be construed to require the disclosure of any trade secret
or other confidential information.
‘‘§ 634. Principles for risk assessment
‘‘(a) IN GENERAL.—The head of each covered Federal agency
shall apply the principles set forth in subsection (b) in order to
assure that significant risk assessment documents and all of their
components distinguish scientific findings from other considerations
and are, to the extent feasible, scientifically objective, unbiased,
and inclusive of all relevant data and rely, to the extent available
and practicable, on scientific findings. Discussions 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 explanation in another agency document which is
available to the public.
‘‘(b) PRINCIPLES.—The principles to be applied are as follows:
‘‘(1) When discussing human health risks, a significant
risk assessment document shall contain a discussion of both
relevant laboratory and relevant epidemiological data of suffi-
cient quality which finds, or fails to find, a correlation between
health risks and a potential toxin or activity. Where conflicts
among such data appear to exist, or where animal data is
used as a basis to assess human health, the significant risk
assessment document shall, to the extent feasible and appro-
priate, include discussion of possible reconciliation of conflicting
information, and as relevant, differences in study designs,
comparative physiology, routes of exposure, bioavailability,
pharmacokinetics, and any other relevant factor, including the
sufficiency of basic data for review. The discussion of possible
reconciliation should indicate whether there is a biological basis
to assume a resulting harm in humans. Animal data shall
be reviewed with regard to its relevancy to humans.
‘‘(2) Where a significant risk assessment document involves
selection of any significant assumption, inference, or model,
the document shall, to the extent feasible—
‘‘(A) present a representative list and explanation of
plausible and alternative assumptions, inferences, or mod-
els;
‘‘(B) explain the basis for any choices;
‘‘(C) identify any policy or value judgments;
‘‘(D) fully describe any model used in the risk assess-
ment and make explicit the assumptions incorporated in
the model; and
‘‘(E) indicate the extent to which any significant model
has been validated by, or conflicts with, empirical data.
‘‘§ 635. Principles for risk characterization and communica-
tion
‘‘Each significant risk characterization document shall meet
each of the following requirements:
‘‘(1) ESTIMATES OF RISK.—The risk characterization shall
describe the populations or natural resources which are the
subject of the risk characterization. If a numerical estimate
of risk is provided, the agency shall, to the extent feasible,
provide—
H. R. 2586—22
‘‘(A) the best estimate or estimates for the specific
populations or natural resources which are the subject
of the characterization (based on the information available
to the Federal agency); and
‘‘(B) a statement of the reasonable range of scientific
uncertainties.
In addition to such best estimate or estimates, the risk
characterization document may present plausible upper-bound
or conservative estimates in conjunction with plausible lower
bound estimates. Where appropriate, the risk characterization
document may present, in lieu of a single best estimate, mul-
tiple best estimates based on assumptions, inferences, or models
which are equally plausible, given current scientific understand-
ing. To the extent practical and appropriate, the document
shall provide descriptions of the distribution and probability
of risk estimates to reflect differences in exposure variability
or sensitivity in populations and attendant uncertainties. Sen-
sitive subpopulations or highly exposed subpopulations include,
where relevant and appropriate, children, the elderly, pregnant
women, and disabled persons.
‘‘(2) EXPOSURE SCENARIOS.—The risk characterization docu-
ment shall explain the 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) COMPARISONS.—The document shall contain a state-
ment that places the nature and magnitude of risks to human
health, safety, or the environment in context. Such statement
shall, to the extent feasible, provide comparisons with estimates
of greater, lesser, and substantially equivalent risks that are
familiar to and routinely encountered by the general public
as well as other risks, and, where appropriate and meaningful,
comparisons of those risks with other similar risks regulated
by the Federal agency resulting from comparable activities
and exposure pathways. Such comparisons should consider rel-
evant distinctions among risks, such as the voluntary or invol-
untary 
nature 
of 
risks 
and 
the 
preventability 
or
nonpreventability of risks.
‘‘(4) SUBSTITUTION RISKS.—Each significant risk assessment
or risk characterization document shall include a statement
of any significant substitution risks to human health, where
information on such risks has been provided to the agency.
‘‘(5) SUMMARIES OF OTHER RISK ESTIMATES.—If—
‘‘(A) a commenter provides a covered Federal agency
with a relevant risk assessment document or a risk
characterization document, and a summary thereof, during
a public comment provided by the agency for a significant
risk assessment document or a significant risk character-
ization document, or, where no comment period is provided
but a commenter provides the covered Federal agency with
the relevant risk assessment document or risk characteriza-
tion document, and a summary thereof, in a timely fashion,
and
‘‘(B) the risk assessment document or risk characteriza-
tion document is consistent with the principles and the
guidance provided under this subchapter,
H. R. 2586—23
the agency shall, to the extent feasible, present such summary
in connection with the presentation of the agency’s significant
risk assessment document or significant risk characterization
document. Nothing in this paragraph shall be construed to
limit the inclusion of any comments or material supplied by
any person to the administrative record of any proceeding.
A document may satisfy the requirements of paragraph (3), (4)
or (5) by reference to information or material otherwise available
to the public if the document provides a brief summary of such
information or material.
‘‘§ 636. Recommendations or classifications by a non-United
States-based entity
‘‘No covered Federal agency shall automatically incorporate
or adopt any recommendation or classification made by a non-
United States-based entity concerning the health effects value of
a substance without an opportunity for notice and comment, and
any risk assessment document or risk characterization document
adopted by a covered Federal agency on the basis of such a rec-
ommendation or classification shall comply with the provisions of
this subchapter. For the purposes of this section, the term ‘non-
United States-based entity’ means—
‘‘(1) any foreign government and its agencies;
‘‘(2) the United Nations or any of its subsidiary organiza-
tions;
‘‘(3) any other international governmental body or inter-
national standards-making organization; or
‘‘(4) any other organization or private entity without a
place of business located in the United States or its territories.
‘‘§ 637. Guidelines and report
‘‘(a) GUIDELINES.—Within 15 months after the date of enact-
ment of this subchapter, the President shall issue guidelines for
Federal agencies consistent with the risk assessment and character-
ization principles set forth in sections 634 and 635 and shall provide
a format for summarizing risk assessment results. In addition,
such guidelines shall include guidance on at least the following
subjects: criteria for scaling animal studies to assess risks to human
health; use of different types of dose-response models; thresholds;
definitions, use, and interpretations of the maximum tolerated dose;
weighting of evidence with respect to extrapolating human health
risks from sensitive species; evaluation of benign tumors, and
evaluation of different human health endpoints.
‘‘(b) REPORT.—Within 3 years after the date of the enactment
of this subchapter, each covered Federal agency shall provide a
report to the Congress evaluating the categories of policy and value
judgments identified under subparagraph (C) of section 634(b)(2).
‘‘(c) PUBLIC COMMENT AND CONSULTATION.—The guidelines and
report under this section, shall be developed after notice and oppor-
tunity for public comment, and after consultation with representa-
tives of appropriate State, local, and tribal governments, and such
other departments and agencies, offices, organizations, or persons
as may be advisable.
‘‘(d) REVIEW.—The President shall review and, where appro-
priate, revise the guidelines published under this section at least
every 4 years.
H. R. 2586—24
‘‘§ 638. Research and training in risk assessment
‘‘(a) EVALUATION.—The head of each covered agency shall regu-
larly and systematically evaluate risk assessment research and
training needs of the agency, including, where relevant and appro-
priate, the following:
‘‘(1) Research to reduce generic data gaps, to address model-
ling needs (including improved model sensitivity), and to vali-
date default options, particularly those common to multiple
risk assessments.
‘‘(2) Research leading to improvement of methods to quan-
tify and communicate uncertainty and variability among
individuals, species, populations, and, in the case of ecological
risk assessment, ecological communities.
‘‘(3) Emerging and future areas of research, including
research on comparative risk analysis, exposure to multiple
chemicals and other stressors, noncancer endpoints, biological
markers of exposure and effect, mechanisms of action in both
mammalian and nonmammalian species, dynamics and prob-
abilities of physiological and ecosystem exposures, and pre-
diction of ecosystem-level responses.
‘‘(4) Long-term needs to adequately train individuals in
risk assessment and risk assessment application. Evaluations
under this paragraph shall include an estimate of the resources
needed to provide necessary training.
‘‘(b) STRATEGY AND ACTIONS TO MEET IDENTIFIED NEEDS.—
The head of each covered agency shall develop a strategy and
schedule for carrying out research and training to meet the needs
identified in subsection (a).
‘‘(c) REPORT.—Not later than 6 months after the date of the
enactment of this subchapter, the head of each covered agency
shall submit to the Congress a report on the evaluations conducted
under subsection (a) and the strategy and schedule developed under
subsection (b). The head of each covered agency shall report to
the Congress periodically on the evaluations, strategy, and schedule.
‘‘§ 639. Study of comparative risk analysis
‘‘(a) IN GENERAL.—(1) The Director of the Office of Management
and Budget, in consultation with the Office of Science and Tech-
nology Policy, shall conduct, or provide for the conduct of, a study
using comparative risk analysis to rank health, safety, and environ-
mental risks and to provide a common basis for evaluating strate-
gies for reducing or preventing those risks. The goal of the study
shall be to improve methods of comparative risk analysis.
‘‘(2) Not later than 90 days after the date of the enactment
of this subchapter, the Director, in collaboration with the heads
of appropriate Federal agencies, shall enter into a contract with
the National Research Council to provide technical guidance on
approaches to using comparative risk analysis and other consider-
ations in setting health, safety, and environmental risk reduction
priorities.
‘‘(b) SCOPE OF STUDY.—The study shall have sufficient scope
and breadth to evaluate comparative risk analysis and to test
approaches for improving comparative risk analysis and its use
in setting priorities for health, safety, and environmental risk reduc-
tion. The study shall compare and evaluate a range of diverse
health, safety, and environmental risks.