[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 3127 Introduced in Senate (IS)]







110th CONGRESS
  2d Session
                                S. 3127

 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 SENATE OF THE UNITED STATES

                             June 12, 2008

 Mr. Burr (for himself and Mr. Kennedy) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 2008''.
    (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 April 2008, there are 72 select agents and 
        toxins, 13 of which are found naturally in the United States.
            (4) As of April 2008, there are 325 entities registered 
        with the Centers for Disease Control and Prevention to work 
        with select agents and toxins and 75 entities registered with 
        the Animal and Plant Health Inspection Service. There are 9,918 
        individuals approved to work with select agents and toxins 
        through the Centers for Disease Control and Prevention and 
        4,336 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.
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