H. R. 2586—25
‘‘(c) STUDY PARTICIPANTS.—In conducting the study, the Direc-
tor shall provide for the participation of a range of individuals
with varying backgrounds and expertise, both technical and non-
technical, 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 subchapter 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 termi-
nation 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 appro-
priate Federal agencies.
‘‘§ 639a. Definitions
‘‘For purposes of this subchapter:
‘‘(1) RISK ASSESSMENT DOCUMENT.—The term ‘risk assess-
ment document’ means a document containing the explanation
of how hazards associated with a substance, activity, or condi-
tion 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 find-
ings 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 environ-
ment 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 Administra-
tion.
‘‘(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.
H. R. 2586—26
‘‘(G) The Department of Agriculture.
‘‘(H) The Consumer Product Safety Commission.
‘‘(I) The National Oceanic and Atmospheric Adminis-
tration.
‘‘(J) The United States Army Corps of Engineers.
‘‘(K) The Mine Safety and Health Administration.
‘‘(L) The Nuclear Regulatory Commission.
‘‘(M) Any other Federal agency considered a covered
Federal agency pursuant to section 413(b)(2)(E).
‘‘(6) FEDERAL AGENCY.—The term ‘Federal agency’ means
an executive department, military department, or independent
establishment as defined in part I of title 5 of the United
States Code, except that such term also includes the Office
of Technology Assessment.
‘‘(7) DOCUMENT.—The term ‘document’ includes material
stored in electronic or digital form.
‘‘§ 639b. Peer review program
‘‘(a) ESTABLISHMENT.—For regulatory programs designed to pro-
tect human health, safety, or the environment, the head of each
Federal agency shall develop a systematic program for independent
and external peer review required by subsection (b). Such program
shall be applicable across the agency and—
‘‘(1) shall provide for the creation of peer review panels
consisting of experts and shall be broadly representative and
balanced and to the extent relevant and appropriate, may
include representatives of State, local, and tribal governments,
small businesses, other representatives of industry, univer-
sities, agriculture, labor, consumers, conservation organiza-
tions, or other public interest groups and organizations;
‘‘(2) may provide for differing levels of peer review and
differing numbers of experts on peer review panels, depending
on the significance or the complexity of the problems or the
need for expeditiousness;
‘‘(3) shall not exclude peer reviewers with substantial and
relevant expertise merely because they represent entities that
may have a potential interest in the outcome, provided that
interest is fully disclosed to the agency and in the case of
a regulatory decision affecting a single entity, no peer reviewer
representing such entity may be included on the panel;
‘‘(4) may provide specific and reasonable deadlines for peer
review panels to submit reports under subsection (c); and
‘‘(5) shall provide adequate protections for confidential busi-
ness information and trade secrets, including requiring peer
reviewers to enter into confidentiality agreements.
‘‘(b) REQUIREMENT FOR PEER REVIEW.—In connection with any
rule that is likely to result in an annual increase in costs of
$100,000,000 or more (other than any rule or other action taken
by an agency to authorize or approve any individual substance
or product), each Federal agency shall provide for peer review
in accordance with this section of any risk assessment or cost
analysis which forms the basis for such rule or of any analysis
under section 431(a). In addition, the Director of the Office of
Management and Budget may order that peer review be provided
for any major risk assessment or cost assessment that is likely
to have a significant impact on public policy decisions.
H. R. 2586—27
‘‘(c) CONTENTS.—Each peer review under this section shall
include a report to the Federal agency concerned with respect
to the scientific and economic merit of data and methods used
for the assessments and analyses.
‘‘(d) RESPONSE
TO PEER REVIEW.—The head of the Federal
agency shall provide a written response to all significant peer
review comments.
‘‘(e) AVAILABILITY TO PUBLIC.—All peer review comments or
conclusions and the agency’s responses shall be made available
to the public and shall be made part of the administrative record.
‘‘(f) PREVIOUSLY REVIEWED DATA
AND ANALYSIS.—No peer
review shall be required under this section for any data or method
which has been previously subjected to peer review or for any
component of any analysis or assessment previously subjected to
peer review.
‘‘(g) NATIONAL PANELS.—The President shall appoint National
Peer Review Panels to annually review the risk assessment and
cost assessment practices of each Federal agency for programs
designed to protect human health, safety, or the environment. The
Panel shall submit a report to the Congress no less frequently
than annually containing the results of such review.
‘‘§ 639c. Petition for review of a major free-standing risk
assessment
‘‘(a) Any interested person may petition an agency to conduct
a scientific review of a risk assessment conducted or adopted by
the agency, except for a risk assessment used as the basis for
a major rule or a site-specific risk assessment.
‘‘(b) The agency shall utilize external peer review, as appro-
priate, to evaluate the claims and analyses in the petition, and
shall consider such review in making its determination of whether
to grant the petition.
‘‘(c) The agency shall grant the petition if the petition estab-
lishes that there is a reasonable likelihood that—
‘‘(1)(A) the risk assessment that is the subject of the petition
was carried out in a manner substantially inconsistent with
the principles in section 633; or
‘‘(B) the risk assessment that is the subject of the petition
does not take into account material significant new scientific
data and scientific understanding;
‘‘(2) the risk assessment that is the subject of the petition
contains significantly different results than if it had been prop-
erly conducted pursuant to subchapter III; and
‘‘(3) a revised risk assessment will provide the basis for
reevaluating an agency determination of risk, and such deter-
mination currently has an effect on the United States economy
equivalent to that of major rule.
‘‘(d) A decision to grant, or final action to deny, a petition
under this subsection shall be made not later than 180 days after
the petition is submitted.
‘‘(e) If the agency grants the petition, it shall complete its
review of the risk assessment not later than 1 year after its decision
to grant the petition. If the agency revises the risk assessment,
in response to its review, it shall do so in accordance with section
633.
H. R. 2586—28
‘‘§ 639d. Risk-based priorities
‘‘(a) PURPOSES.—The purposes of this section are to—
‘‘(1) encourage Federal agencies engaged in regulating risks
to human health, safety, and the environment to achieve the
greatest risk reduction at the least cost practical;
‘‘(2) promote the coordination of policies and programs to
reduce risks to human health, safety, and the environment;
and
‘‘(3) promote open communication among Federal agencies,
the public, the President, and Congress regarding environ-
mental, health, and safety risks, and the prevention and
management of those risks.
‘‘(b) DEFINITIONS.—For the purposes of this section:
‘‘(1) COMPARATIVE RISK ANALYSIS.—The term ‘comparative
risk analysis’ means a process to systematically estimate, com-
pare, and rank the size and severity of risks to provide a
common basis for evaluating strategies for reducing or prevent-
ing those risks.
‘‘(2) COVERED AGENCY.—The term ‘covered agency’ means
each of the following:
‘‘(A) The Environmental Protection Agency.
‘‘(B) The Department of Labor.
‘‘(C) The Department of Transportation.
‘‘(D) The Food and Drug Administration.
‘‘(E) The Department of Energy.
‘‘(F) The Department of the Interior.
‘‘(G) The Department of Agriculture.
‘‘(H) The Consumer Product Safety Commission.
‘‘(I) The National Oceanic and Atmospheric Adminis-
tration.
‘‘(J) The United States Army Corps of Engineers.
‘‘(K) The Nuclear Regulatory Commission.
‘‘(3) EFFECT.—The term ‘effect’ means a deleterious change
in the condition of—
‘‘(A) a human or other living thing (including death,
cancer, or other chronic illness, decreased reproductive
capacity, or disfigurement); or
‘‘(B) an inanimate thing important to human welfare
(including destruction, degeneration, the loss of intended
function, and increased costs for maintenance).
‘‘(4) IRREVERSIBILITY.—The term ‘irreversibility’ means the
extent to which a return to conditions before the occurrence
of an effect are either very slow or will never occur.
‘‘(5) LIKELIHOOD.—The term ‘likelihood’ means the esti-
mated probability that an effect will occur.
‘‘(6) MAGNITUDE.—The term ‘magnitude’ means the number
of individuals or the quantity of ecological resources or other
resources that contribute to human welfare that are affected
by exposure to a stressor.
‘‘(7) SERIOUSNESS.—The term ‘seriousness’ means the inten-
sity of effect, the likelihood, the irreversibility, and the mag-
nitude.
‘‘(c) DEPARTMENT AND AGENCY PROGRAM GOALS.—
‘‘(1) SETTING
PRIORITIES.—In exercising authority under
applicable laws protecting human health, safety, or the environ-
ment, the head of each covered agency shall set priorities