Home > 104th Congressional Bills > H.R. 1023 (ih) To provide procedures for claims for compassionate payments with regard to individuals with blood-clotting disorders, such as hemophilia, who contracted human immunodeficiency virus due to contaminated blood products. [Introduced in House]...H.R. 1023 (ih) To provide procedures for claims for compassionate payments with regard to individuals with blood-clotting disorders, such as hemophilia, who contracted human immunodeficiency virus due to contaminated blood products. [Introduced in House]...
104th CONGRESS
1st Session
H. R. 1022
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 2 (legislative day, February 22), 1995
Received; read twice and referred to the Committee on Governmental
Affairs
_______________________________________________________________________
AN ACT
To provide regulatory reform and to focus national economic resources
on the greatest risks to human health, safety, and the environment
through scientifically objective and unbiased risk assessments and
through the consideration of costs and benefits in major rules, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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 regulations have led
to dramatic improvements in the environment and have
significantly reduced human health risk; however, the Federal
regulations that have led to these improvements have been more
costly and less effective than they could have been; too often,
regulatory priorities have not been based upon a realistic
consideration of risk, risk reduction opportunities, and costs.
(2) The public and private resources available to address
health, safety, and environmental concerns 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
related to the incremental benefits.
(3) To provide more cost-effective and cost-reasonable
protection to human health and the environment, regulatory
priorities should be based upon realistic consideration of
risk; the priority setting process must include scientifically
sound, objective, and unbiased risk assessments, comparative
risk analysis, 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; scientific and other data must be
better collected, organized, and evaluated; most importantly,
the critical information resulting from a risk assessment must
be effectively communicated in an objective and unbiased manner
to decision makers, and from decision makers to the public.
(5) The public stake holders must be fully involved 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 regulations.
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. 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 comply with the provisions of this Act
within as reasonable 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 required by law to be approved
by a Federal department 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 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. 5. DEFINITIONS.
For purposes of this Act:
(1) Costs.--The term ``costs'' includes the direct and
indirect costs to the United States Government, 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, environmental, social
and economic benefits that are expected to result directly or
indirectly from implementation 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 services, or health care diagnostic services.
(5) Emergency.--As used in this Act, the term ``emergency''
means a situation that is immediately impending and
extraordinary in nature, demanding attention due to a
condition, circumstance, or practice reasonably expected to
cause death, serious illness, or severe injury to humans, or
substantial endangerment to private property or the environment
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 available to other Federal
agencies, subject to applicable confidentiality 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 guidelines
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 health, safety, and
environmental risks in order to provide for sound regulatory
decisions and public education;
(2) to provide for full consideration and discussion 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 characterizations.
SEC. 103. EFFECTIVE DATE; APPLICABILITY; SAVINGS PROVISIONS.
(a) Effective Date.--Except as otherwise specifically 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 paragraph (3), this
title applies to all significant risk assessment documents and
significant risk characterization documents, as defined in
paragraph (2).
(2) Significant risk assessment document or significant
risk characterization document.--(A) As used in this title, 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:
(i) Any proposed or final major rule, including any
analysis or certification under title 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 Comprehensive Environmental
Response, Compensation, and Liability Act of 1980, and
any other environmental restoration 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
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 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 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 substance other than
municipal waste.
(D) Within 15 months after the date of the enactment of
this Act, 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 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 including
documents in the categories.
(iii) The need to make expeditious administrative
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 appropriate.
(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 Federal agencies should be
considered covered Federal agencies for purposes of this title.
Such determination, with respect to a particular Federal
agency, shall be based on the impact of risk assessment
documents 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
title, 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 title 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
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 results of such
analysis are used as the basis for imposing restrictions on
substances or activities.
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