(B) DEADLINES
FOR
COMPLIANCE.—The
Director shall ensure that risk assessment guide-
lines issued by the Environmental Protection
Agency are consistent with the requirements of
paragraph (3) according to the following sched-
ule:
(i) Not later than 3 years after the
date of the enactment of this Act, for guide-
lines that were issued by the Environmental
Protection Agency, or are under develop-
ment, prior to the date of the enactment of
this Act.
(ii) On the date of their issuance, for
guidelines that are developed and issued by
the Environmental Protection Agency after
the date of the enactment of this Act.
(C) UPDATES.—The Director shall review
the need to update the guidelines referred to in
clauses (i) and (ii) of subparagraph (B) not less
than once every 3 years after the date by which
such guidelines are made consistent with the re-
quirements of paragraph (4).
(D) INTERIM GUIDANCE.—Whenever the Di-
rector determines that there has been a signifi-
cant scientific advancement which warrants the
updating of a guideline or that a specific risk
assessment need has arisen which is not ad-
dressed by a guideline, the Director, after provid-
ing for appropriate scientific peer review and
opportunity for public participation, shall pro-
vide interim guidance on the use of the guide-
lines and the conduct of the risk assessments. The
Director shall make available to the public any
interim guidance provided, the results of any sci-
entific peer review conducted, and any public
comment received, under this paragraph. The
Director shall issue the interim guidance in ac-
cordance with paragraph (2) and, as appro-
priate, shall incorporate the interim guidance
into the guideline when the Director next reviews
the need to update that guideline under subpara-
graph (C).
(2) PROCESS FOR GUIDELINE DEVELOPMENT.—
When developing or revising a risk assessment guide-
line or interim guidance, the Director shall publish in
the Federal Register a declaration of the intent to
issue the guideline or interim guidance, together with
the text of the proposed guideline or interim guidance,
and shall provide an opportunity for public notice
and comment on the proposal. After the close of the
comment period and any informal hearing that may
be held, the Director shall prepare and place in the
public record a response to the comments that were
submitted on the proposal and shall issue the new or
revised guideline or interim guidance by publishing
the document in the Federal Register along with a
summary of the Director’s response to comments.
(3) SCOPE
AND
APPLICABILITY
OF
GUIDE-
LINES.—The guidelines shall address issues relevant
to human and ecological risk assessments and to fun-
damental aspects of risk assessment procedures and
practices. The Administrator shall conduct risk as-
sessments in accordance with all appropriate guide-
lines. Discussions or explanations required under
paragraph (4) need not be repeated in each risk as-
sessment as long as there is reference to the relevant
discussion or explanation in another Agency docu-
ment. Exercises conducted by the Environmental Pro-
tection Agency which serve an internal planning
function, and which do not support a final Agency
action or rule, may be determined by the Director not
to be subject to the provisions of this Act. Screening
analyses where the results of such analyses are not
used as the basis for imposing restrictions on sub-
stances or activities and the results of the analyses
are not used to characterize a positive finding of risks
from substances or activities in any final Agency doc-
ument made available to the general public shall be
excluded from the provisions of this Act. A risk assess-
ment which departs from a guideline and which is
conducted in support of an emergency action, an ex-
pedited formal adjudication, emergency rule, or emer-
gency order which does not permit adequate time for
adherence to the procedures set forth in section
4(g)(2), shall be exempt from the provisions of section
4(g)(2).
(4) CONTENTS.—The risk assessment guidelines
shall, at a minimum, include each of the following:
(A) An explanation of the scope and appli-
cability of the guidelines, including appropriate
limitations or restrictions on their use, and an
identification of appropriate Offices at the Envi-
ronmental Protection Agency to contact for fur-
ther information on risk assessment.
(B) Criteria for accepting and evaluating
data.
(C) A complete description of any mathe-
matical models or other assumptions likely to be
used in the risk assessment, including a discus-
sion of their plausibility.
(D) A description of the default options, the
justification and validation for the default op-
tions, and an explicit statement of the rationale
for selecting a particular default option, in the
absence of adequate data, based on explicitly
stated science policy choices and consideration of
relevant scientific information.
(E) The technical justification for, and a
description of the degree of, conservatism each
default option imposes upon the risk assessment.
(F) Criteria for using iterative or tiered ap-
proaches to risk assessment, with varying levels
of effort and data requirements in the conduct of
risk assessment based on the need for accuracy of
the risk estimate.
(G) Criteria for conducting uncertainty
analysis during the course of the risk assessment,
and an explanation of the data needs for such
analysis.
(H) Guidance for risk characterization de-
veloped, issued, and updated under subsection
(h).
(I) Effective methods for reporting risk as-
sessment, to ensure that the results are reason-
ably understandable by interested persons, in-
cluding formats which clearly identify and dis-
tinguish sources of uncertainty and variability
in the risk assessment.
(J) Criteria for identification and use of the
most plausible and unbiased methodologies and
assumptions, given the scientific information
available to the Administrator.
(5) REPORT.—Not later than 180 days after the
date of the enactment of this Act, the Administrator
shall submit to the Congress a report that describes
(A) the status of all risk assessment guidelines issued
before such date with respect to the extent to which
such guidelines are consistent with the requirements
of paragraph (4) and a schedule for making such
guidelines consistent with such requirements; (B) a
schedule for issuing any risk assessment guidelines
which are being developed by the Environmental Pro-
tection Agency on such date, including a plan for
making such guidelines consistent with the require-
ments of paragraph (4); and (C) a plan for identify-
ing and developing future risk assessment guidelines
consistent with the requirements of paragraph (4).
The Administrator shall annually thereafter submit to
the Congress an update of the schedule referred to in
shall consider and incorporate, as appropriate, the
recommendations from the study of the Committee on
Risk Characterization of the National Academy of
Sciences on risk characterization and report to the
Congress on the inclusion of such recommendations in
the risk characterization guidance.
(2) DEADLINES.—The Director shall ensure that
initial risk characterization guidance is issued,
through publication in the Federal Register, within 2
years after the date of the enactment of this Act.
(3) CONTENTS.—At a minimum, the guidance
shall require that any risk characterization contain
the following:
(A) Relevant information on data and as-
sessment methods that significantly influence the
risk estimate.
(B) A statement of the limitations, assump-
tions, and default options included in the assess-
ment and a statement of the rationale and extent
of scientific consensus with respect to their use.
(C) A statement that identifies major uncer-
tainties and their influence upon the assessment.
The statement shall characterize uncertainties
associated with experimental measurement errors
and uncertainties associated with the choice of
specific models and default options.
(D) The range and distribution of exposures
derived from exposure scenarios used in a risk
assessment, including, for example, upper-bound
and central estimate(s) and their qualitative, or
where possible quantitative, likelihood, and,
when available and appropriate, the identifica-
tion of highly susceptible groups, species, indi-
viduals, and subpopulations whose exposure ex-
ceeds that of the general population.
(E) The use of both quantitative and quali-
tative descriptors, when available and appro-
priate, to present a comprehensive range of risks
which are or may be encountered by the various
populations and individuals in a human health
risk assessment, or by the various species and ec-
ological communities in an ecological risk assess-
ment, exposed to the environmental hazard being
evaluated in the risk assessment.
(F) A description of appropriate statistical
expressions of the range and variability of the
risk estimate, including the population or popu-
lations addressed by any risk estimate(s), central
estimates of the risk for the specific population,
any appropriate upper-bound and lower-bound
estimates, and the reasonable range or other de-
scription of uncertainties in the assessment proc-
ess.
(G) When providing estimates of risk to
public health, appropriate comparisons with es-
timates of other risks to health, including those
that are familiar to and routinely encountered
by the general public, and relevant substitution
risks, where information on such risks is made
available to the Administrator. In stating com-
parisons, the Administrator shall identify rel-
evant distinctions among categories or risks and
limitations to comparisons.
(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 risk charac-
terization guidance developed, issued, and updated
under this subsection. The Administrator shall report
to the Congress whenever risk characterization guid-
ance under this subsection is updated.
(i) RISK COMMUNICATION.—The Director shall insti-
tute a program to promote open dialogue among scientists,
decisionmakers, and the public in order to improve the un-
derstanding of risk assessments by decisionmakers and to
accurately and clearly communicate risk characterizations.
(j) RESEARCH AND TRAINING IN RISK ASSESSMENT.—
(1) EVALUATION.—The Director shall regularly
and systematically evaluate risk assessment research
and training needs of the Environmental Protection
Agency, including the following needs:
(A) Research with respect to data gaps or
redundancies, modelling needs, and validation of
default options, particularly those common to
multiple risk assessments.
(B) Research to examine the causes and ex-
tent of variability within and among individ-
uals, species, populations, and, in the case of eco-
logical risk assessment, ecological communities.
(C) Research leading to the improvement of
methods to quantify and communicate uncer-
tainty and variability throughout the risk assess-
ment, and risk assessment reporting methods
that clearly distinguish between uncertainty and
variability.
(D) Emerging and future areas of research,
including research on comparative risk analysis,
exposure to multiple chemicals and other
stressors, noncancer endpoints, biological mark-
ers, mechanisms of action in both mammalian
and non-mammalian species, dynamics and
probabilities of physiological and ecosystem expo-
sures, and prediction of ecosystem-level responses.
(E) Long-term needs to adequately train in-
dividuals in risk assessment and risk assessment
applications. An evaluation under this para-
graph shall include an estimate of the resources
needed to provide necessary training and rec-
ommendations on appropriate educational risk
assessment curricula.
(2) DEVELOPMENT OF STRATEGY.—The Director
shall develop a strategy, schedule, and delegation of
responsibility for carrying out research and training
to meet the needs identified in paragraph (1).
(3) REPORT.—Not later than 120 days after the
date of the enactment of this Act, the Administrator
shall submit to the Congress a report on the evalua-
tions conducted under paragraph (1) and the strategy
and schedule developed under paragraph (2). The Ad-
ministrator shall report to the Congress whenever the
evaluations, strategy, and schedule are updated or
modified.
(k) REVIEW OF RISK CHARACTERIZATIONS.—
(1) PROVISION FOR INDEPENDENT REVIEW.—On
an annual basis for a period of three years following
the date of issuance of risk characterization guidance
by the Environmental Protection Agency under the
provisions of this Act, and every three years there-
after, the Director shall provide for review of the con-
formance of the Agency’s risk characterizations with
its risk characterization guidance. The review shall be
conducted by an independent body composed of indi-
viduals from outside the Agency who are technically
qualified in risk characterization. By publication in
the Federal Register of the intent to convene each re-
view and of a period for public comment, the public
will be provided an opportunity for comment to the
independent body on the Agency’s conformance with
the guidance.
(2) ANNUAL REPORT.—Not later than December
1 each year, the independent body shall provide to the
Congress, through the Administrator, a report that
evaluates the degree to which the risk characterization
issued by the Environmental Protection Agency dur-
ing the preceding calendar year conform to the risk
characterization guidance issued under subsection (h).
The report shall include an identification of those risk
characterizations, if any, that the independent body