Home > 104th Congressional Bills > H.R. 1023 (ih) To provide procedures for claims for compassionate payments with regard to individuals with blood-clotting disorders, such as hemophilia, who contracted human immunodeficiency virus due to contaminated blood products. [Introduced in House]...H.R. 1023 (ih) To provide procedures for claims for compassionate payments with regard to individuals with blood-clotting disorders, such as hemophilia, who contracted human immunodeficiency virus due to contaminated blood products. [Introduced in House]...
(C) The risk assessment principle set forth in section
104(b)(1) need not apply to any risk assessment or risk
characterization document described in clause (iii) of
paragraph (2)(B). The risk characterization and communication
principle set forth in section 105(4) need not apply to any
risk assessment or risk characterization document described in
clause (v) or (vi) of paragraph (2)(B).
(c) Savings Provisions.--The provisions of this title shall be
supplemental to any other provisions of law relating to risk
assessments and risk characterizations, except that nothing in this
title shall be construed to modify any statutory standard or statutory
requirement designed to protect health, safety, or the environment.
Nothing in this title shall be interpreted to preclude the
consideration of any data or the calculation of any estimate to more
fully describe risk or provide examples of scientific uncertainty or
variability. Nothing in this title shall be construed to require the
disclosure of any trade secret or other confidential information.
SEC. 104. 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 sufficient
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
appropriate, 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 models;
(B) explain the basis for any choices;
(C) identify any policy or value judgments;
(D) fully describe any model used in the risk
assessment 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.
SEC. 105. PRINCIPLES FOR RISK CHARACTERIZATION AND COMMUNICATION.
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--
(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
bounds estimates. Where appropriate, the risk characterization
document may present, in lieu of a single best estimate,
multiple best estimates based on assumptions, inferences, or
models which are equally plausible, given current scientific
understanding. 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. Sensitive subpopulations or highly
exposed subpopulations include, where relevant and appropriate,
children, the elderly, pregnant women, and disabled persons.
(2) Exposure scenarios.--The risk characterization document
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 statement
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 relevant
distinctions among risks, such as the voluntary or involuntary
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 characterization document, or, where no comment
period is provided but a commenter provides the covered
Federal agency with the relevant risk assessment
document or risk characterization document, and a
summary thereof, in a timely fashion, and
(B) the risk assessment document or risk
characterization document is consistent with the
principles and the guidance provided under this title,
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.
SEC. 106. 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 recommendation or classification shall comply with
the provisions of this title. 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
organizations;
(3) any other international governmental body or
international standards-making organization; or
(4) any other organization or private entity without a
place of business located in the United States or its
territories.
SEC. 107. GUIDELINES AND REPORT.
(a) Guidelines.--Within 15 months after the date of enactment of
this title, the President shall issue guidelines for Federal agencies
consistent with the risk assessment and characterization principles set
forth in sections 104 and 105 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 enactment of this title, 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 104(b)(2).
(c) Public Comment and Consultation.--The guidelines and report
under this section, shall be developed after notice and opportunity for
public comment, and after consultation with representatives 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 appropriate,
revise the guidelines published under this section at least every 4
years.
SEC. 108. RESEARCH AND TRAINING IN RISK ASSESSMENT.
(a) Evaluation.--The head of each covered agency shall regularly
and systematically evaluate risk assessment research and training needs
of the agency, including, where relevant and appropriate, the
following:
(1) Research to reduce generic data gaps, to address
modelling needs (including improved model sensitivity), and to
validate default options, particularly those common to multiple
risk assessments.
(2) Research leading to improvement of methods to quantify
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 probabilities
of physiological and ecosystem exposures, and prediction 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 Act, 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.
SEC. 109. 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 Technology
Policy, shall conduct, or provide for the conduct of, a study using
comparative risk analysis to rank health, safety, and environmental
risks and to provide a common basis for evaluating strategies 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
Act, 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 considerations 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 reduction. The
study shall compare and evaluate a range of diverse health, safety, and
environmental risks.
(c) Study Participants.--In conducting the study, the Director
shall provide for the participation 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 study 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) Recommendations for Improving Comparative Risk Analysis and Its
Use.--Not later than 90 days after the termination of the study, the
Director shall submit to the Congress the report of the National
Research Council with recommendations regarding the use of comparative
risk analysis and ways to improve the use of comparative risk analysis
for decision-making in appropriate Federal agencies.
SEC. 110. DEFINITIONS.
For purposes of this title:
(1) Risk assessment document.--The term ``risk assessment
document'' means a document containing the explanation of how
hazards associated with a substance, activity, or condition
have been identified, quantified, and assessed. The term also
includes a written statement accepting the findings of any such
document.
(2) Risk characterization document.--The term ``risk
characterization document'' means a document quantifying or
describing the degree of toxicity, exposure, or other risk
posed by hazards associated with a substance, activity, or
condition to which individuals, populations, or resources are
exposed. The term also includes a written statement accepting
the findings of any such document.
(3) Best estimate.--The term ``best estimate'' means a
scientifically appropriate estimate which is based, to the
extent feasible, on one of the following:
(A) Central estimates of risk using the most
plausible assumptions.
(B) An approach which combines multiple estimates
based on different scenarios and weighs the probability
of each scenario.
(C) Any other methodology designed to provide the
most unbiased representation of the most plausible
level of risk, given the current scientific information
available to the Federal agency concerned.
(4) Substitution risk.--The term ``substitution risk''
means a potential risk to human health, safety, or the
environment from a regulatory alternative designed to decrease
other risks.
(5) Covered federal agency.--The term ``covered Federal
agency'' means each of the following:
(A) The Environmental Protection Agency.
(B) The Occupational Safety and Health
Administration.
(C) The Department of Transportation (including the
National Highway Transportation Safety Administration).
(D) The Food and Drug Administration.
(E) The Department of Energy.
(F) The Department of the Interior.
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