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SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Risk Assessment and
Cost-Benefit Act of 1995’’.
SEC. 2. FINDINGS.
The Congress finds that:
(1) Environmental, health, and safety regula-
tions have led to dramatic improvements in the envi-
ronment and have significantly reduced human
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
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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-
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
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of unnecessary and overly complex regulations will
also be necessary.
SEC. 3. COVERAGE OF ACT.
This Act 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-
ply with the provisions of this Act within as reason-
able 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. 4. UNFUNDED MANDATES.
Nothing in this Act itself shall, without Federal fund-
ing and further Federal agency action, create any new ob-
ligation 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.
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SEC. 5. DEFINITIONS.
For purposes of this Act:
(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
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 Act, the
term ‘‘emergency’’ means a situation that is imme-
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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-
tial endangerment to private property or the envi-
ronment if no action is taken.
SEC. 6. AVAILABILITY OF INFORMATION AMONG FEDERAL
AGENCIES.
Covered Federal agencies shall make existing
databases and information developed under this Act avail-
able to other Federal agencies, subject to applicable con-
fidentiality requirements, for the purpose of meeting the
requirements of this Act. Within 15 months after the date
of enactment of this Act, the President shall issue guide-
lines for Federal agencies to comply with this section.
TITLE I—RISK ASSESSMENT AND
COMMUNICATION
SEC. 101. SHORT TITLE.
This title may be cited as the ‘‘Risk Assessment and
Communication Act of 1995’’.
SEC. 102. 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
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health, safety, and environmental risks in order to
provide for sound regulatory decisions and public
education;
(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. 103. 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
title.
(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-
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cant risk assessment document’’ and ‘‘significant
risk characterization document’’ include, at a mini-
mum, risk assessment documents or risk character-
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
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Response, Compensation, and Liability Act of
1980, and any other environmental restoration
and waste management carried out by or on be-
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.