H. R. 2586—17
‘‘(ii) the rule adopts the alternative with the least net
cost of the reasonable alternatives that achieve the objectives
of the statute.
‘‘(8) Notwithstanding section 551(16), for purposes of this sub-
section with regard to any rule proposed or issued by an appropriate
Federal banking agency (as that term is defined in section 3(q)
of the Federal Deposit Insurance Act (12 U.S.C. 1813(q)), the
National Credit Union Administration, or the Office of Federal
Housing Enterprise Oversight, the term ‘Director’ means the head
of such agency, Administration, or Office.’’.
(5) Section 553 of title 5, United States Code, is further amend-
ed by adding after subsection (i) the following:
‘‘(j) To the extent practicable, the head of an agency shall
seek to ensure that any proposed major rule or regulatory impact
analysis of such a rule is written in a reasonably simple and
understandable manner and provides adequate notice of the content
of the rule to affected persons.’’.
(6) Section 553 of title 5, United States Code, is further amend-
ed by adding after subsection (j) the following:
‘‘(k)(1) The provisions of this section regarding major rules
shall not apply if—
‘‘(A) the agency for good cause finds that conducting cost-
benefit analysis is impracticable due to an emergency, or health
or safety threat, or a food safety threat that is likely to result
in significant harm to the public or natural resources; and
‘‘(B) the agency publishes in the Federal Register, together
with such finding, a succinct statement of the basis for the
finding.
‘‘(2) Not later than one year after the promulgation of a final
major rule to which paragraph (1) applies, the agency shall comply
with the provisions of this subchapter and, as thereafter necessary,
revise the rule.
(7) Section 553 of title 5, United States Code, is further amend-
ed by adding after subsection (k) the following:
‘‘(l) The provisions of this section regarding major rules shall
not apply to—
‘‘(1) any regulation proposed or issued in connection with
the implementation of monetary policy or to ensure the safety
and soundness of federally insured depository institutions, any
affiliate of such institution, credit unions, or government spon-
sored housing enterprises regulated by the Office of Federal
Housing Enterprise Oversight;
‘‘(2) any agency action that the head of the agency certifies
is limited to interpreting, implementing, or administering the
internal revenue laws of the United States, including any regu-
lation proposed or issued in connection with ensuring the collec-
tion of taxes from a subsidiary of a foreign company doing
business in the United States; and
‘‘(3) any regulation proposed or issued pursuant to section
553 of title 5, United States Code, in connection with imposing
trade sanctions against any country that engages in illegal
trade activities against the United States that are injurious
to American technology, jobs, pensions, or general economic
well-being.’’.
(8) The Director of the Office of Management and Budget shall
submit a report to the Congress no later than 24 months after
the date of the enactment of this Act containing an analysis of
H. R. 2586—18
rulemaking procedures of Federal agencies and an analysis of the
impact of those rulemaking procedures on the regulated public
and regulatory process.
(9) The amendments made by this subsection shall apply only
to final agency rules issued after rulemaking begun after the date
of enactment of this Act.
SEC. 2003. RISK ASSESSMENT.
(a) IN GENERAL.—Chapter 6 of title 5, United States Code,
is amended by adding at the end the following:
‘‘SUBCHAPTER III—RISK ASSESSMENTS
‘‘§ 631. Short title
‘‘This subchapter may be cited as the ‘Risk Assessment and
Communication Act of 1995’.
‘‘§ 632. Purposes
‘‘The purposes of this subchapter are—
‘‘(1) to present the public and executive branch with the
most scientifically objective and unbiased information concern-
ing the nature and magnitude of health, safety, and environ-
mental risks in order to provide for sound regulatory decisions
and public education;
‘‘(2) to provide for full consideration and discussion of rel-
evant 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 characterizations.
‘‘§ 633. Effective date; applicability; savings provisions
‘‘(a) EFFECTIVE DATE.—Except as otherwise specifically provided
in this subchapter, the provisions of this subchapter shall take
effect 18 months after the date of enactment of this subchapter.
‘‘(b) APPLICABILITY.—
‘‘(1) IN GENERAL.—Except as provided in paragraph (3),
this subchapter applies to all significant risk assessment docu-
ments and significant risk characterization documents, as
defined in paragraph (2).
‘‘(2) SIGNIFICANT RISK ASSESSMENT DOCUMENT OR SIGNIFI-
CANT RISK CHARACTERIZATION DOCUMENT.—(A) As used in this
subchapter, the terms ‘significant risk assessment document’
and ‘significant risk characterization document’ include, at a
minimum, risk assessment documents or risk characterization
documents prepared by or on behalf of a covered Federal agency
in the implementation of a regulatory 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 administrative record
for that item.
‘‘(B) The items referred to in subparagraph (A) are the
following:
H. R. 2586—19
‘‘(i) Any proposed or final major rule, including any
analysis or certification under subchapter II, promulgated
as part of any Federal regulatory 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 action under the Com-
prehensive Environmental Response, Compensation, and
Liability Act of 1980, and any other environmental restora-
tion and waste management carried out by or on behalf
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 operation under Federal
laws administered by the Environmental Protection Agency
or the Department of the Interior. Nothing in this section
(iii) shall apply to the requirements of section 404 of the
Clean Water Act.
‘‘(iv) Any report to Congress.
‘‘(v) Any regulatory action to place a substance on
any official list of carcinogens or toxic or hazardous sub-
stances 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 regarding risk assessment
or risk characterization.
‘‘(C) The terms ‘significant risk assessment document’ and
‘significant risk characterization document’ shall also include
the following:
‘‘(i) Any such risk assessment and risk characterization
documents provided by a covered Federal agency to the
public and which are likely to result in an annual effect
on the economy of $75,000,000 or more.
‘‘(ii) Environmental restoration and waste management
carried out by or on behalf of the Department of Defense
with respect to any substance other than municipal waste.
‘‘(D) Within 15 months after the date of the enactment
of this subchapter, each covered Federal agency administering
a regulatory program designed to protect human health, safety,
or the environment shall promulgate a rule establishing those
additional categories, if any, of risk assessment and risk
characterization 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 subchapter. 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 including docu-
ments in the categories.
‘‘(iii) The need to make expeditious administrative deci-
sions regarding documents in the categories.
H. R. 2586—20
‘‘(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 appropriate.
‘‘(E)(i) Not later than 18 months after the date of the
enactment of this subchapter, the President, acting through
the Director of the Office of Management and Budget, shall
determine whether any other Federal agencies should be consid-
ered covered Federal agencies for purposes of this subchapter.
Such determination, with respect to a particular Federal
agency, shall be based on the impact of risk assessment docu-
ments 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.
The effective date of such a determination shall be no later
than 6 months after the date of the determination.
‘‘(ii) Not later than 15 months after the President, acting
through the Director of the Office of Management and Budget,
determines pursuant to clause (i) that a Federal agency should
be considered a covered Federal agency for purposes of this
subchapter, the head of that agency shall promulgate a rule
pursuant to subparagraph (D) to establish additional categories
of risk assessment and risk characterization documents
described in that subparagraph.
‘‘(3) EXCEPTIONS.—(A) This subchapter does not apply to
risk assessment or risk characterization documents containing
risk assessments or risk characterizations performed with
respect to the following:
‘‘(i) A screening analysis, where appropriately labeled
as such, including a screening analysis for purposes of
product regulation or premanufacturing notices.
‘‘(ii) Any health, safety, or environmental inspections.
‘‘(iii) The sale or lease of Federal resources or regu-
latory 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 results of such analysis
are used as the basis for imposing restrictions on substances
or activities.
‘‘(C) The risk assessment principle set forth in section
634(b)(1) need not apply to any risk assessment or risk
characterization document described in clause (iii) of paragraph
(2)(B). The risk characterization and communication principle
set forth in section 635(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 subchapter
shall be supplemental to any other provisions of law relating to
risk assessments and risk characterizations, except that nothing
in this subchapter shall be construed to modify any statutory stand-
ard or statutory requirement designed to protect health, safety,
or the environment. Nothing in this subchapter shall be interpreted
to preclude the consideration of any data or the calculation of