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health risk; however, the Federal regulations that
have led to these improvements have been more cost-
ly and less effective than they could have been; too
often, regulatory priorities have not been based upon
a realistic consideration of risk, risk reduction op-
portunities, and costs.
(2) The public and private resources available
to address health, safety, and environmental con-
cerns are not unlimited; those resources need to be
allocated to address the greatest needs in the most
cost-effective manner and so that the incremental
costs of regulatory alternatives are reasonably relat-
ed to the incremental benefits.
(3) To provide more cost-effective and cost-rea-
sonable protection to human health and the environ-
ment, regulatory priorities should be based upon re-
alistic consideration of risk; the priority setting proc-
ess must include scientifically sound, objective, and
unbiased risk assessments, comparative risk analy-
sis, and risk management choices that are grounded
in cost-benefit principles.
(4) Risk assessment has proven to be a useful
decision making tool; however, improvements are
needed in both the quality of assessments and the
characterization and communication of findings; sci-
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entific and other data must be better collected, orga-
nized, and evaluated; most importantly, the critical
information resulting from a risk assessment must
be effectively communicated in an objective and un-
biased manner to decision makers, and from decision
makers to the public.
(5) The public stake holders must be fully in-
volved in the risk-decision making process. They
have the right-to-know about the risks addressed by
regulation, the amount of risk to be reduced, the
quality of the science used to support decisions, and
the cost of implementing and complying with regula-
tions. This knowledge will allow for public scrutiny
and promote quality, integrity, and responsiveness of
agency decisions.
(6) Although risk assessment is one important
method to improve regulatory decision-making, other
approaches to secure prompt relief from the burden
of unnecessary and overly complex regulations will
also be necessary.
SEC. 403. COVERAGE OF DIVISION.
This division does not apply to any of the following:
(1) A situation that the head of an affected
Federal agency determines to be an emergency. In
such circumstance, the head of the agency shall com-
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ply with the provisions of this division within as rea-
sonable a time as is practical.
(2) Activities necessary to maintain military
readiness.
(3) Any individual food, drug, or other product
label, or to any risk characterization appearing on
any such label, if the individual product label is re-
quired by law to be approved by a Federal depart-
ment or agency prior to use.
(4) Approval of State programs or plans by
Federal agencies.
SEC. 404. UNFUNDED MANDATES.
Nothing in this division itself shall, without Federal
funding and further Federal agency action, create any new
obligation or burden on any State or local government or
otherwise impose any financial burden on any State or
local government in the absence of Federal funding, except
with respect to routine information requests.
SEC. 405. DEFINITIONS.
For purposes of this division:
(1) COSTS.—The term ‘‘costs’’ includes the di-
rect and indirect costs to the United States Govern-
ment, to State, local, and tribal governments, and to
the private sector, wage earners, consumers, and the
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economy, of implementing and complying with a rule
or alternative strategy.
(2) BENEFIT.—The term ‘‘benefit’’ means the
reasonably identifiable significant health, safety, en-
vironmental, social and economic benefits that are
expected to result directly or indirectly from imple-
mentation of a rule or alternative strategy.
(3) MAJOR
RULE.—The term ‘‘major rule’’
means any regulation that is likely to result in an
annual increase in costs of $25,000,000 or more.
Such term does not include any regulation or other
action taken by an agency to authorize or approve
any individual substance or product.
(4) PROGRAM DESIGNED TO PROTECT HUMAN
HEALTH.—The term ‘‘program designed to protect
human health’’ does not include regulatory programs
concerning health insurance, health provider serv-
ices, or health care diagnostic services.
(5) EMERGENCY.—As used in this division, the
term ‘‘emergency’’ means a situation that is imme-
diately impending and extraordinary in nature, de-
manding attention due to a condition, circumstance,
or practice reasonably expected to cause death, seri-
ous illness, or severe injury to humans, or substan-
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tial endangerment to private property or the envi-
ronment if no action is taken.
SEC. 406. AVAILABILITY OF INFORMATION AMONG FED-
ERAL AGENCIES.
Covered Federal agencies shall make existing
databases and information developed under this division
available to other Federal agencies, subject to applicable
confidentiality requirements, for the purpose of meeting
the requirements of this division. Within 15 months after
the date of enactment of this division, the President shall
issue guidelines for Federal agencies to comply with this
section.
TITLE I—RISK ASSESSMENT AND
COMMUNICATION
SEC. 411. SHORT TITLE.
This title may be cited as the ‘‘Risk Assessment and
Communication Act of 1995’’.
SEC. 412. PURPOSES.
The purposes of this title are—
(1) to present the public and executive branch
with the most scientifically objective and unbiased
information concerning the nature and magnitude of
health, safety, and environmental risks in order to
provide for sound regulatory decisions and public
education;
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(2) to provide for full consideration and discus-
sion of relevant data and potential methodologies;
(3) to require explanation of significant choices
in the risk assessment process which will allow for
better peer review and public understanding; and
(4) to improve consistency within the executive
branch in preparing risk assessments and risk char-
acterizations.
SEC. 413. EFFECTIVE DATE; APPLICABILITY; SAVINGS PRO-
VISIONS.
(a) EFFECTIVE DATE.—Except as otherwise specifi-
cally provided in this title, the provisions of this title shall
take effect 18 months after the date of enactment of this
Act.
(b) APPLICABILITY.—
(1) IN GENERAL.—Except as provided in para-
graph (3), this title applies to all significant risk as-
sessment documents and significant risk character-
ization documents, as defined in paragraph (2).
(2) SIGNIFICANT RISK ASSESSMENT DOCUMENT
OR
SIGNIFICANT
RISK
CHARACTERIZATION
DOCU-
MENT.—(A) As used in this title, the terms ‘‘signifi-
cant risk assessment document’’ and ‘‘significant
risk characterization document’’ include, at a mini-
mum, risk assessment documents or risk character-
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ization documents prepared by or on behalf of a cov-
ered Federal agency in the implementation of a reg-
ulatory program designed to protect human health,
safety, or the environment, used as a basis for one
of the items referred to in subparagraph (B), and—
(i) included by the agency in that item; or
(ii) inserted by the agency in the adminis-
trative record for that item.
(B) The items referred to in subparagraph (A)
are the following:
(i) Any proposed or final major rule, in-
cluding any analysis or certification under title
II, promulgated as part of any Federal regu-
latory program designed to protect human
health, safety, or the environment.
(ii) Any proposed or final environmental
clean-up plan for a facility or Federal guidelines
for the issuance of any such plan. As used in
this clause, the term ‘‘environmental clean-up’’
means a corrective action under the Solid
Waste Disposal Act, a removal or remedial ac-
tion under the Comprehensive Environmental
Response, Compensation, and Liability Act of
1980, and any other environmental restoration
and waste management carried out by or on be-
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half of a covered Federal agency with respect to
any substance other than municipal waste.
(iii) Any proposed or final permit condition
placing a restriction on facility siting or oper-
ation under Federal laws administered by the
Environmental Protection Agency or the De-
partment of the Interior. Nothing in this sec-
tion (iii) shall apply to the requirements of sec-
tion 404 of the Clean Water Act.
(iv) Any report to Congress.
(v) Any regulatory action to place a sub-
stance on any official list of carcinogens or
toxic or hazardous substances or to place a new
health effects value on such list, including the
Integrated Risk Information System Database
maintained by the Environmental Protection
Agency.
(vi) Any guidance, including protocols of
general applicability, establishing policy regard-
ing risk assessment or risk characterization.
(C) The terms ‘‘significant risk assessment doc-
ument’’ and ‘‘significant risk characterization docu-
ment’’ shall also include the following:
(i) Any such risk assessment and risk
characterization documents provided by a cov-
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ered Federal agency to the public and which are
likely to result in an annual increase in costs of
$25,000,000 or more.
(ii) Environmental restoration and waste
management carried out by or on behalf of the
Department of Defense with respect to any sub-
stance other than municipal waste.
(D) Within 15 months after the date of the en-
actment of this Act, each covered Federal agency ad-
ministering a regulatory program designed to protect
human health, safety, or the environment shall pro-
mulgate a rule establishing those additional cat-
egories, if any, of risk assessment and risk charac-
terization documents prepared by or on behalf of the
covered Federal agency that the agency will consider
significant risk assessment documents or significant
risk characterization documents for purposes of this
title. In establishing such categories, the head of the
agency shall consider each of the following:
(i) The benefits of consistent compliance
by documents of the covered Federal agency in
the categories.
(ii) The administrative burdens of includ-
ing documents in the categories.
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(iii) The need to make expeditious admin-
istrative decisions regarding documents in the
categories.
(iv) The possible use of a risk assessment
or risk characterization in any compilation of
risk hazards or health or environmental effects
prepared by an agency and commonly made
available to, or used by, any Federal, State, or
local government agency.
(v) Such other factors as may be appro-
priate.
(E)(i) Not later than 18 months after the date
of the enactment of this Act, the President, acting
through the Director of the Office of Management
and Budget, shall determine whether any other Fed-
eral agencies should be considered covered Federal
agencies for purposes of this title. Such determina-
tion, with respect to a particular Federal agency,
shall be based on the impact of risk assessment doc-
uments and risk characterization documents on—
(I) regulatory programs administered by
that agency; and
(II) the communication of risk information
by that agency to the public.
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The effective date of such a determination shall be
no later than 6 months after the date of the deter-
mination.
(ii) Not later than 15 months after the Presi-
dent, acting through the Director of the Office of
Management and Budget, determines pursuant to
clause (i) that a Federal agency should be consid-
ered a covered Federal agency for purposes of this
title, the head of that agency shall promulgate a rule
pursuant to subparagraph (D) to establish addi-
tional categories of risk assessment and risk charac-
terization documents described in that subpara-
graph.
(3) EXCEPTIONS.—(A) This title does not apply
to risk assessment or risk characterization docu-
ments containing risk assessments or risk character-
izations performed with respect to the following:
(i) A screening analysis, where appro-
priately labeled as such, including a screening
analysis for purposes of product regulation or
premanufacturing notices.
(ii) Any health, safety, or environmental
inspections.
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(iii) The sale or lease of Federal resources
or regulatory activities that directly result in
the collection of Federal receipts.
(B) No analysis shall be treated as a screening
analysis for purposes of subparagraph (A) if the re-
sults of such analysis are used as the basis for im-
posing restrictions on substances or activities.
(C) The risk assessment principle set forth in
section 414(b)(1) need not apply to any risk assess-
ment or risk characterization document described in
clause (iii) of paragraph (2)(B). The risk character-
ization and communication principle set forth in sec-
tion 415(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, ex-
cept 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 uncer-
tainty or variability. Nothing in this title shall be con-
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strued to require the disclosure of any trade secret or
other confidential information.
SEC. 414. 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 doc-
uments 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 prac-
ticable, 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 sig-
nificant 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
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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, compara-
tive physiology, routes of exposure, bioavailability,
pharmacokinetics, and any other relevant factor, in-
cluding the sufficiency of basic data for review. The
discussion of possible reconciliation should indicate
whether there is a biological basis to assume a re-
sulting harm in humans. Animal data shall be re-
viewed with regard to its relevancy to humans.
(2) Where a significant risk assessment docu-
ment involves selection of any significant assump-
tion, inference, or model, the document shall, to the
extent feasible—
(A) present a representative list and expla-
nation 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 assump-
tions incorporated in the model; and
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(E) indicate the extent to which any sig-
nificant model has been validated by, or con-
flicts with, empirical data.
SEC. 415. PRINCIPLES FOR RISK CHARACTERIZATION AND
COMMUNICATION.
Each significant risk characterization document shall
meet each of the following requirements:
(1) ESTIMATES OF RISK.—The risk character-
ization shall describe the populations or natural re-
sources which are the subject of the risk character-
ization. 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 plau-
sible upper-bound or conservative estimates in con-
junction with plausible lower bounds estimates.
Where appropriate, the risk characterization docu-
ment may present, in lieu of a single best estimate,
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multiple best estimates based on assumptions, infer-
ences, or models which are equally plausible, given
current scientific understanding. To the extent prac-
tical and appropriate, the document shall provide de-
scriptions of the distribution and probability of risk
estimates to reflect differences in exposure varia-
bility or sensitivity in populations and attendant un-
certainties. Sensitive subpopulations or highly ex-
posed subpopulations include, where relevant and
appropriate, children, the elderly, pregnant women,
and disabled persons.
(2) EXPOSURE SCENARIOS.—The risk charac-
terization document shall explain the exposure sce-
narios used in any risk assessment, and, to the ex-
tent 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 con-
tain a statement that places the nature and mag-
nitude of risks to human health, safety, or the envi-
ronment in context. Such statement shall, to the ex-
tent 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 ap-
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propriate and meaningful, comparisons of those risks
with other similar risks regulated by the Federal
agency resulting from comparable activities and ex-
posure pathways. Such comparisons should consider
relevant distinctions among risks, such as the vol-
untary or involuntary nature of risks and the pre-
ventability or nonpreventability of risks.
(4) SUBSTITUTION
RISKS.—Each significant
risk assessment or risk characterization document
shall include a statement of any significant substi-
tution 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 Fed-
eral agency with a relevant risk assessment doc-
ument or a risk characterization document, and
a summary thereof, during a public comment
provided by the agency for a significant risk as-
sessment document or a significant risk charac-
terization document, or, where no comment pe-
riod is provided but a commenter provides the
covered Federal agency with the relevant risk
assessment document or risk characterization
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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 in-
clusion of any comments or material supplied by any
person to the administrative record of any proceed-
ing.
A document may satisfy the requirements of paragraph
(3), (4) or (5) by reference to information or material oth-
erwise available to the public if the document provides a
brief summary of such information or material.
SEC. 416. RECOMMENDATIONS OR CLASSIFICATIONS BY A
NON-UNITED STATES-BASED ENTITY.
No covered Federal agency shall automatically incor-
porate 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 docu-
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(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 ‘‘substi-
tution risk’’ means a potential risk to human health,
safety, or the environment from a regulatory alter-
native designed to decrease other risks.
(5) COVERED
FEDERAL
AGENCY.—The term
‘‘covered Federal agency’’ means each of the follow-
ing:
(A) The Environmental Protection Agency.
(B) The Occupational Safety and Health
Administration.
(C) The Department of Transportation
(including the National Highway Transpor-
tation Safety Administration).
(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 Com-
mission.