‘‘(i)(1) The principles to be applied in any assessment
of risks relied upon by the Secretary in promulgating or
modifying any standard are as follows:
‘‘(A) When discussing risk to health or safety,
a risk assessment document shall contain a discus-
sion of both relevant laboratory and relevant epide-
miological data of sufficient quality which finds, or
fails to find, a correlation between risks to health or
safety and a potential toxin, condition, process, or
activity. Where conflicts among such data appear to
exist, or where animal data are used as a basis to
assess human health, the risk assessment document
shall, to the extent feasible and appropriate, include
discussion of possible reconciliation of conflicting in-
formation, and as relevant, differences in study de-
signs, comparative physiology, routes of exposure,
bioavailability, pharmacokinetics, and any other rel-
evant factor, including the sufficiency of basic data
for review. Animal data shall be reviewed with re-
gard to its relevancy to humans.
‘‘(B) Where a risk assessment document in-
volves selection of any significant assumption, infer-
ence, or model, the document shall, to the extent
feasible—
‘‘(i) present a representative list and expla-
nation of plausible and alternative assumptions,
inferences, or models;
‘‘(ii) explain the basis for any choices;
‘‘(iii) identify any policy or value judg-
ments;
‘‘(iv) fully describe any model used in the
risk assessment and make explicit the assump-
tions incorporated in the model; and
‘‘(v) indicate the extent to which any sig-
nificant model has been validated by, or con-
flicts with, empirical data.
‘‘(2) Any characterization of risk relied upon by the
Secretary in promulgating or modifying a standard shall,
to the extent feasible, provide—
‘‘(A) the best estimate or estimates for the spe-
cific classes of workers which are the subject of the
characterization; and
‘‘(B) a statement of the reasonable range of sci-
entific uncertainties.
In addition to such best estimate or estimates, the risk
characterization may present plausible upper-bound or
conservative estimates in conjunction with plausible lower
bounds estimates. Where appropriate, the risk character-
ization 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
understanding.
‘‘(3) Any characterization of risk relied upon by the
Secretary in promulgating or modifying a standard shall
explain the exposure scenarios used in any risk assess-
ment, and, to the extent feasible, provide a statement of
the size of the corresponding population at risk and the
likelihood of such exposure scenarios.
‘‘(4) Any characterization of risk relied upon by the
Secretary in promulgating or modifying a standard shall
contain a statement that places the nature and magnitude
of risks to worker health or safety in context. Such state-
ment shall, to the extent feasible, provide comparisons
with estimates of greater, lesser, and substantially equiva-
lent 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 Secretary. Such
comparisons should consider relevant distinctions among
risks, such as the voluntary or involuntary nature of risks
and the preventability or nonpreventability of risks.
‘‘(5) If—
‘‘(A) a commenter provides the Secretary with
a relevant risk assessment document or a risk char-
acterization document, and a summary thereof, dur-
ing the public comment period provided under sec-
tion 6(b), and
‘‘(B) the risk assessment document or risk
characterization document is consistent with the
principles and the guidance provided under this Act,
the Secretary shall, to the extent feasible, present
such summary in connection with the presentation
of the Secretary’s description of the risk to health
or safety of employees. Nothing in this paragraph
shall be construed to limit the inclusion of any com-
ments or material supplied by any person to the ad-
ministrative record. A document may satisfy the re-
quirements of paragraph (3) or (4) by reference to
information or material otherwise available to the
public if the document provides a brief summary of
such information or material.
‘‘(j) Any recommendation or classification made by
a non-United States-based entity concerning the health ef-
fects value of a substance shall not be incorporated into
any standard without an opportunity for notice and com-
ment. For the purposes of this subsection, 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.’’.
(f) COST-BENEFIT ANALYSIS.—Section 6 (29 U.S.C.
655), as amended by subsection (e), is amended by adding
at the end the following:
‘‘(k) Each identification of the costs and benefits of
a final or proposed standard shall include the following:
‘‘(1) An identification of reasonable alternative
strategies, including strategies that—
‘‘(A) require no government action;
‘‘(B) will accommodate differences among
differing types of operations and among em-
ployers with different levels of resources with
which to comply; and
‘‘(C) employ performance or other market-
based mechanisms that permit the greatest
flexibility in achieving the identified benefits of
the standard.
The Secretary shall consider reasonable alternative
strategies proposed during the comment period.
‘‘(2) An analysis of the incremental costs and
incremental risk reduction or other benefits associ-
ated with each alternative strategy identified or con-
sidered by the Secretary. Costs and benefits shall be
quantified to the extent feasible and appropriate and
may otherwise be qualitatively described.
‘‘(3) A statement that places in context the na-
ture and magnitude of the risks to be addressed and
the residual risks likely to remain for each alter-
native strategy identified or considered by the Sec-
retary. Such statement shall, to the extent feasible,
provide comparisons with estimates of greater, less-
er, and substantially equivalent risks that are famil-
iar to and routinely encountered by the general pub-
lic as well as other risks, and, where appropriate and
meaningful, comparisons of those risks with other
similar risks regulated by the Secretary. Such com-
parisons should consider relevant distinctions among
risks, such as the voluntary or involuntary nature of
risks and the preventability or nonpreventability of
risks.
‘‘(4) For each final rule, an analysis of whether
the identified benefits of the standard are likely to
exceed the identified costs of the standard.
‘‘(5) An analysis of the effect of the standard—