Select Agent Program and Biosafety Improvement Act of 2009 - Amends the Public Health Service Act and the Agricultural Bioterrorism Protection Act of 2002 to reauthorize appropriations for the Select Agent Program, which lists and controls biological agents and toxins that have the potential to pose a severe threat to public health and safety. Requires appropriate training of individuals handling or using such agents and toxins.
Includes the Department of Homeland Security (DHS) among the federal agencies limited in the disclosure of information related to listed agents or toxins.
Requires the Secretary of Health and Human Services to contract with the National Academy of Sciences to review and make recommendations for improving the Select Agent Program.
Sets forth additional factors that the Secretary must consider in determining whether to list an agent or toxin, including whether the agent or toxin is endemic to the United States.
Requires the Secretary to issue guidance on inventorying and monitoring listed biological agents.
Directs the Attorney General to issue guidance regarding the scope of the statutory definition of "variola virus."
Requires the Secretary to: (1) develop guidelines for how laboratories and laboratory personnel that do not regularly test for listed agents and toxins may be rapidly accessed and utilized during emergencies; and (2) evaluate national needs of, and oversight of, high containment biological laboratories.
Provides for the development of minimum standards for laboratory biosafety and biosecurity training for relevant personnel of high containment biological laboratories.
Requires the Secretary to establish a Biological Laboratory Incident Reporting System.
[Congressional Bills 111th Congress]
[From the U.S. Government Printing Office]
[H.R. 1225 Introduced in House (IH)]
111th CONGRESS
1st Session
H. R. 1225
To reauthorize the Select Agent Program by amending the Public Health
Service Act and the Agricultural Bioterrorism Protection Act of 2002
and to improve oversight of high containment laboratories.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 26, 2009
Ms. Harman (for herself and Mr. Rogers of Michigan) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committees on Agriculture and the
Judiciary, for a period to be subsequently determined by the Speaker,
in each case for consideration of such provisions as fall within the
jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To reauthorize the Select Agent Program by amending the Public Health
Service Act and the Agricultural Bioterrorism Protection Act of 2002
and to improve oversight of high containment laboratories.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Select Agent
Program and Biosafety Improvement Act of 2009''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
TITLE I--SELECT AGENT PROGRAM REAUTHORIZATION
Sec. 101. Reauthorization of select agent program.
Sec. 102. Select agent program review.
Sec. 103. Revision of the list of biological agents and toxins.
Sec. 104. Sharing information with trusted State partners.
Sec. 105. Improvements to inventorying and monitoring of agents.
Sec. 106. Smallpox definition clarification.
Sec. 107. Plan for surge in samples of biological agents and toxins.
TITLE II--BIOSAFETY IMPROVEMENTS
Sec. 201. Improvement of oversight of biocontainment laboratories.
Sec. 202. Improvement of training for laboratory personnel.
Sec. 203. Biological laboratory incident reporting system.
SEC. 2. FINDINGS.
Congress finds the following:
(1) The Centers for Disease Control and Prevention
regulates the possession, use, and transfer of select agents
and toxins that have the potential to pose a severe threat to
public health and safety.
(2) The Animal and Plant Health Inspection Service
regulates the possession, use, and transfer of select agents
and toxins that have the potential to pose a severe threat to
animal or plant health, or to animal or plant products.
(3) As of February 2009, there are 82 select agents and
toxins, 13 of which are found naturally in the United States.
(4) As of February 2009, there are 336 entities registered
with the Centers for Disease Control and Prevention to work
with select agents and toxins and 64 entities registered with
the Animal and Plant Health Inspection Service. There are
10,463 individuals approved to work with select agents and
toxins through the Centers for Disease Control and Prevention
and 4,149 through the Animal and Plant Health Inspection
Service.
(5) Biocontainment laboratories are used by scientists to
study infectious materials safely and effectively. Laboratory
biological research is categorized by the safety level at which
it is performed. There are 4 safety levels, termed Biosafety
Level (BSL) 1 through 4.
TITLE I--SELECT AGENT PROGRAM REAUTHORIZATION
SEC. 101. REAUTHORIZATION OF SELECT AGENT PROGRAM.
(a) Reauthorization of Select Agent Program.--
(1) Amendment to the public health service act.--Section
351A(m) of the Public Health Service Act (42 U.S.C. 262a(m)) is
amended by striking ``2002 through 2007'' and inserting ``2009
through 2013''.
(2) Amendment to the agricultural bioterrorism protection
act of 2002.--Section 212(m) of the Agricultural Bioterrorism
Protection Act of 2002 (7 U.S.C. 8401(m)) is amended by
striking ``2002 through 2007'' and inserting ``2009 through
2013''.
(b) Appropriate Training.--
(1) Amendment to the public health service act.--Section
351A(e)(2)(A) of the Public Health Service Act (42 U.S.C.
262a(e)(2)(A)) is amended by inserting ``, and appropriate
training,'' after ``have a legitimate need''.
(2) Amendment to the agricultural bioterrorism protection
act of 2002.--Section 212(e)(2)(A) of the Agricultural
Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(e)(2)(A)) is
amended by inserting ``, and appropriate training,'' after
``have a legitimate need''.
(c) Covered Agencies.--
(1) Amendment to the public health service act.--Section
351A(h)(2)(A) (42 U.S.C. 262a(h)(2)(A)) of the Public Health
Service Act is amended by inserting ``the Department of
Homeland Security,'' after ``the Department of Agriculture,''.
(2) Amendment to the agricultural bioterrorism protection
act of 2002.--Section 212(h)(2)(A) of the Agricultural
Bioterrorism Protection Act of 2002 (7 U.S.C. 8401(h)(2)(A)) is
amended by inserting ``the Department of Homeland Security,''
after ``the Department of Agriculture,''.
SEC. 102. SELECT AGENT PROGRAM REVIEW.
(a) In General.--The Secretary of Health and Human Services, in
consultation with the Secretary of Agriculture, shall enter into a
contract with the National Academy of Sciences to conduct a review of
the select agent program under section 351A of the Public Health
Service Act (42 U.S.C. 262a) and section 212 of the Agricultural
Bioterrorism Protection Act of 2002 (7 U.S.C. 8401). Such review shall
focus on--
(1) the extent to which the program has enhanced
biosecurity and biosafety in the United States;
(2) the effects of the program on--
(A) international scientific collaboration; and
(B) scientific advances in the United States; and
(3) other issues as requested by the Secretary of Health
and Human Services and the Secretary of Agriculture.
(b) Report; Recommendations.--Not later than 240 days after the
date of enactment of this Act, the National Academy of Sciences shall
submit a report to the Secretary of Health and Human Services, the
Secretary of Agriculture, the Committee on Health, Education, Labor,
and Pensions of the Senate, the Committee on Energy and Commerce of the
House of Representatives, and other congressional committees of
relevant interest, on the results of the review conducted under
subsection (a). Such report shall include recommendations for improving
the structure of the select agent program for--
(1) enhancing the biosecurity and biosafety of the United
States;
(2) eliminating or reducing adverse effects of the program,
if any, on--
(A) international scientific collaboration; and
(B) scientific advances in the United States; and
(3) other issues as requested by the Secretary of Health
and Human Services and the Secretary of Agriculture.
SEC. 103. REVISION OF THE LIST OF BIOLOGICAL AGENTS AND TOXINS.
(a) Amendment to the Public Health Service Act.--Section
351A(a)(1)(B)(i) of the Public Health Service Act (42 U.S.C.
262a(a)(1)(B)(i)) is amended--
(1) in subclause (III), by striking ``; and'' and inserting
a semicolon;
(2) by redesignating subclause (IV) as subclause (VII); and
(3) by inserting after subclause (III) the following:
``(IV) whether the agent or toxin
is endemic to the United States, as
defined by the Secretary;
``(V) information available from
biological risk assessments conducted
by the Department of Homeland Security;
``(VI) newly discovered agents of
disease, including genetically modified
organisms or agents created
synthetically; and''.
(b) Amendment to the Agricultural Bioterrorism Protection Act of
2002.--Section 212(a)(1)(B)(i) of the Agricultural Bioterrorism
Protection Act of 2002 (7 U.S.C. 8401(a)(1)(B)(i)) is amended--
(1) in subclause (III), by striking ``; and'' and inserting
a semicolon;
(2) by redesignating subclause (IV) as subclause (VII); and
(3) by inserting after subclause (III) the following:
``(IV) whether the agent or toxin
is endemic to the United States, as
defined by the Secretary;
``(V) information available from
biological risk assessments conducted
by the Department of Homeland Security;
``(VI) newly discovered agents of
disease, including genetically modified
organisms or agents created
synthetically; and''.
(c) Rule of Construction.--The amendments made by subsections (a)
and (b) shall not be construed to preclude the listing of a biological
agent or toxin that is endemic to the United States.
SEC. 104. SHARING INFORMATION WITH TRUSTED STATE PARTNERS.
(a) Amendment to the Public Health Service Act.--Section 351A(h)(5)
of the Public Health Service Act (42 U.S.C. 262a(h)(5)) is amended--
(1) in subparagraph (A), by striking ``; or'' and inserting
a semicolon;
(2) in subparagraph (B), by striking the period and
inserting ``; or''; and
(3) by inserting at the end the following:
``(C) to withhold information regarding a State
that will assist with the State's emergency
preparedness planning from the health director (or
equivalent State official) of such State, if such State
has in place a law to protect against the further
release of such information as determined by the
Secretary.''.
(b) Amendment to the Agricultural Bioterrorism Protection Act of
2002.--Section 212(h)(5) of the Agricultural Bioterrorism Protection
Act of 2002 (7 U.S.C. 8401(h)(5)) is amended--
(1) in subparagraph (A), by striking ``; or'' and inserting
a semicolon;
(2) in subparagraph (B), by striking the period and
inserting ``; or''; and
(3) by inserting at the end the following:
``(C) to withhold information regarding a State
that will assist with the State's emergency
preparedness planning from an elected or appointed
senior State agricultural official or equivalent State
official (such as a State veterinarian or a State plant
health regulatory official) of such State, if such
State has in place a law to protect against the further
release of such information as determined by the
Secretary.''.
SEC. 105. IMPROVEMENTS TO INVENTORYING AND MONITORING OF AGENTS.
(a) Improved Method To Inventory and Monitor Listed Biological
Agents.--Not later than 180 days after enactment of this Act, the
Secretary of Health and Human Services, in coordination with the
Secretary of Agriculture, and in consultation with individuals with
appropriate scientific expertise, shall issue guidance on inventorying
and monitoring the biological agents listed under section 351A(a)(1) of
the Public Health Service Act (42 U.S.C. 262a(a)(1)) and the biological
agents listed under section 212(a)(1) of the Agricultural Bioterrorism
Protection Act of 2002 (7 U.S.C. 8401(a)(1)).
(b) Considerations.--In issuing the guidance under subsection (a),
the Secretaries shall consider--
(1) the effectiveness of measures to inventory and monitor
listed biological agents that can propagate relative to the
burden of these measures on laboratory personnel;
(2) qualitative and quantitative control procedures for
such listed agents, rather than only quantitative control
procedures; and
(3) in what situations registered persons are required to
keep inventory records.
SEC. 106. SMALLPOX DEFINITION CLARIFICATION.
Not later than 90 days after the date of enactment of this Act, the
Attorney General, in coordination with the Secretary of Health and
Human Services, shall issue public guidance regarding how the Attorney
General interprets the scope of the statutory definition of ``variola
virus'' in section 175c of title 18, United States Code.
SEC. 107. PLAN FOR SURGE IN SAMPLES OF BIOLOGICAL AGENTS AND TOXINS.
The Secretary of Health and Human Services, in coordination with
the Secretary of Agriculture and State officials, shall develop and
disseminate guidelines for how laboratories and laboratory personnel
that do not regularly test for listed agents and toxins (as such terms
are defined in section 351A of the Public Health Service Act (42 U.S.C.
262a) and section 212 of the Agricultural Bioterrorism Protection Act
of 2002 (7 U.S.C. 8401)) may be rapidly accessed and utilized during
emergencies in which laboratories and laboratory personnel that
regularly test for such agents and toxins are overwhelmed by a surge of
samples of such listed agents and toxins.
TITLE II--BIOSAFETY IMPROVEMENTS
SEC. 201. IMPROVEMENT OF OVERSIGHT OF BIOCONTAINMENT LABORATORIES.
(a) Definition.--For purposes of this section, the term ``high
containment biological laboratory'' means a laboratory that has
Biosafety Level 3 or Biosafety Level 4 facilities, as defined by the
Secretary of Health and Human Services and the Secretary of
Agriculture.
(b) Evaluation.--The Secretary of Health and Human Services, in
coordination with the Secretary of Agriculture, and in consultation
with the Secretary of Defense and the Secretary of Homeland Security
(referred to in this section as the ``Secretaries'') shall, either
directly or through a contract, evaluate national needs of, and
oversight of, high containment biological laboratories.
(c) Considerations.--In conducting the evaluation under subsection
(b), the Secretaries shall consider--
(1) whether the construction of high containment biological
laboratories that are in existence or planned as of the date of
enactment of this Act, is likely to provide sufficient capacity
for the needs of Government biodefense and infectious disease
research;
(2) how laboratory capacity and lessons learned can be best
shared across the biodefense and infectious disease research
communities, domestically and internationally;
(3) whether guidance on laboratory infrastructure,
commissioning, operation, and maintenance of such laboratories
is adequate, and if such guidance is found to be inadequate,
how to improve and streamline such guidance; and
(4) ways to improve and streamline the training of the
personnel of such laboratories, including recommendations
regarding the minimum standards for laboratory biosafety and
biosecurity training under section 202.
(d) Report to Congress.--Not later than 240 days after the date of
enactment of this Act, the Secretary of Health and Human Services shall
submit to Congress a report on the findings and recommendations from
the evaluation under this section.
SEC. 202. IMPROVEMENT OF TRAINING FOR LABORATORY PERSONNEL.
(a) Definition.--For purposes of this section, the term ``high
containment biological laboratory'' means a laboratory that has
Biosafety Level 3 or Biosafety Level 4 facilities, as defined by the
Secretary of Health and Human Services and the Secretary of
Agriculture.
(b) Development of Minimum Standards.--The Secretary of Health and
Human Services, acting through the Director of the Centers for Disease
Control and Prevention and the Director of the National Institutes of
Health, and in coordination with the Secretary of Agriculture and
scientific experts representing appropriate professional groups and
international health organizations, shall develop minimum standards for
laboratory biosafety and biosecurity training for relevant personnel of
high containment biological laboratories. In developing such standards,
the Secretary of Health and Human Services shall consider existing
laboratory guidelines and training modules.
(c) Requirement for Approval.--A person may not register with the
Secretary of Health and Human Services or the Secretary of Agriculture
for the possession, use, or transfer of listed agents in accordance
with section 351A of the Public Health Service Act (42 U.S.C. 262a) and
section 212 of the Agricultural Bioterrorism Protection Act of 2002 (7
U.S.C. 8401) unless the person provides to its appropriate personnel
biosafety and biosecurity training that meets the minimum standards
under subsection (b) in addition to any other requirements determined
appropriate by the Secretary of Health and Human Services or the
Secretary of Agriculture.
(d) Dissemination.--The Secretary of Health and Human Services, in
coordination with the Secretary of Agriculture, may disseminate the
minimum standards under subsection (b) for voluntary use, such as when
use is not required under subsection (b), in laboratories and academic
programs in the United States and in other countries.
SEC. 203. BIOLOGICAL LABORATORY INCIDENT REPORTING SYSTEM.
(a) In General.--The Secretary of Health and Human Services, in
coordination with the Secretary of Agriculture, (referred to in this
section as the ``Secretaries'') shall establish an integrated
Biological Laboratory Incident Reporting System through which personnel
of biological laboratories may voluntarily report biosafety or
biosecurity incidents of concern and the Secretaries may identify
trends in such incidents and protocols for biosafety or biosecurity
improvements. In developing such reporting system, the Secretaries
shall consider options for integrating existing voluntary and required
reporting mechanisms.
(b) Functions.--In implementing the reporting system under
subsection (a), the Secretaries shall enter into a contract with a
public or private entity that does not regulate biological laboratories
to administer the reporting system. Such entity shall--
(1) receive and process incident reports;
(2) analyze, interpret incident data, and identify incident
trends;
(3) issue alert messages within an appropriate time period;
(4) disseminate reports and other appropriate information,
which shall not include facility-specific information;
(5) not have authority to direct corrective action or to
initiate enforcement action;
(6) ensure anonymity of individuals reporting to the
system, to the extent permitted by law; and
(7) conduct other activities as requested by the
Secretaries.
<all>
Introduced in House
Introduced in House
Sponsor introductory remarks on measure. (CR E495)
Referred to House Energy and Commerce
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Agriculture, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to House Agriculture
Referred to House Judiciary
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.
Referred to the Subcommittee on Horticulture and Organic Agriculture.
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