HR 1225 IHCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

February 26, 2009CommentsClose CommentsPermalink

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 concernedCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

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’.CommentsClose CommentsPermalink





(b) Table of Contents- The table of contents for this Act is as follows:CommentsClose CommentsPermalink





Sec. 1. Short title; table of contents.CommentsClose CommentsPermalink





Sec. 2. Findings.CommentsClose CommentsPermalink

TITLE I--SELECT AGENT PROGRAM REAUTHORIZATION

Sec. 101. Reauthorization of select agent program.CommentsClose CommentsPermalink





Sec. 102. Select agent program review.CommentsClose CommentsPermalink





Sec. 103. Revision of the list of biological agents and toxins.CommentsClose CommentsPermalink





Sec. 104. Sharing information with trusted State partners.CommentsClose CommentsPermalink





Sec. 105. Improvements to inventorying and monitoring of agents.CommentsClose CommentsPermalink





Sec. 106. Smallpox definition clarification.CommentsClose CommentsPermalink





Sec. 107. Plan for surge in samples of biological agents and toxins.CommentsClose CommentsPermalink

TITLE II--BIOSAFETY IMPROVEMENTS

Sec. 201. Improvement of oversight of biocontainment laboratories.CommentsClose CommentsPermalink





Sec. 202. Improvement of training for laboratory personnel.CommentsClose CommentsPermalink





Sec. 203. Biological laboratory incident reporting system.CommentsClose CommentsPermalink

SEC. 2. FINDINGS.

Congress finds the following:CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(3) As of February 2009, there are 82 select agents and toxins, 13 of which are found naturally in the United States.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

TITLE I--SELECT AGENT PROGRAM REAUTHORIZATIONCommentsClose CommentsPermalink

SEC. 101. REAUTHORIZATION OF SELECT AGENT PROGRAM.

(a) Reauthorization of Select Agent Program-CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(b) Appropriate Training-CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(c) Covered Agencies-CommentsClose CommentsPermalink





(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,’.CommentsClose CommentsPermalink





(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,’.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) the extent to which the program has enhanced biosecurity and biosafety in the United States;CommentsClose CommentsPermalink





(2) the effects of the program on--CommentsClose CommentsPermalink





(A) international scientific collaboration; andCommentsClose CommentsPermalink





(B) scientific advances in the United States; andCommentsClose CommentsPermalink





(3) other issues as requested by the Secretary of Health and Human Services and the Secretary of Agriculture.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(1) enhancing the biosecurity and biosafety of the United States;CommentsClose CommentsPermalink





(2) eliminating or reducing adverse effects of the program, if any, on--CommentsClose CommentsPermalink





(A) international scientific collaboration; andCommentsClose CommentsPermalink





(B) scientific advances in the United States; andCommentsClose CommentsPermalink





(3) other issues as requested by the Secretary of Health and Human Services and the Secretary of Agriculture.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) in subclause (III), by striking ‘; and’ and inserting a semicolon;CommentsClose CommentsPermalink





(2) by redesignating subclause (IV) as subclause (VII); andCommentsClose CommentsPermalink





(3) by inserting after subclause (III) the following:CommentsClose CommentsPermalink





‘(IV) whether the agent or toxin is endemic to the United States, as defined by the Secretary;CommentsClose CommentsPermalink





‘(V) information available from biological risk assessments conducted by the Department of Homeland Security;CommentsClose CommentsPermalink





‘(VI) newly discovered agents of disease, including genetically modified organisms or agents created synthetically; and’.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(1) in subclause (III), by striking ‘; and’ and inserting a semicolon;CommentsClose CommentsPermalink





(2) by redesignating subclause (IV) as subclause (VII); andCommentsClose CommentsPermalink





(3) by inserting after subclause (III) the following:CommentsClose CommentsPermalink





‘(IV) whether the agent or toxin is endemic to the United States, as defined by the Secretary;CommentsClose CommentsPermalink





‘(V) information available from biological risk assessments conducted by the Department of Homeland Security;CommentsClose CommentsPermalink





‘(VI) newly discovered agents of disease, including genetically modified organisms or agents created synthetically; and’.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) in subparagraph (A), by striking ‘; or’ and inserting a semicolon;CommentsClose CommentsPermalink





(2) in subparagraph (B), by striking the period and inserting ‘; or’; andCommentsClose CommentsPermalink





(3) by inserting at the end the following:CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(1) in subparagraph (A), by striking ‘; or’ and inserting a semicolon;CommentsClose CommentsPermalink





(2) in subparagraph (B), by striking the period and inserting ‘; or’; andCommentsClose CommentsPermalink





(3) by inserting at the end the following:CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

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)).CommentsClose CommentsPermalink





(b) Considerations- In issuing the guidance under subsection (a), the Secretaries shall consider--CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(2) qualitative and quantitative control procedures for such listed agents, rather than only quantitative control procedures; andCommentsClose CommentsPermalink





(3) in what situations registered persons are required to keep inventory records.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

TITLE II--BIOSAFETY IMPROVEMENTSCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(c) Considerations- In conducting the evaluation under subsection (b), the Secretaries shall consider--CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(2) how laboratory capacity and lessons learned can be best shared across the biodefense and infectious disease research communities, domestically and internationally;CommentsClose CommentsPermalink





(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; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(1) receive and process incident reports;CommentsClose CommentsPermalink





(2) analyze, interpret incident data, and identify incident trends;CommentsClose CommentsPermalink





(3) issue alert messages within an appropriate time period;CommentsClose CommentsPermalink





(4) disseminate reports and other appropriate information, which shall not include facility-specific information;CommentsClose CommentsPermalink





(5) not have authority to direct corrective action or to initiate enforcement action;CommentsClose CommentsPermalink





(6) ensure anonymity of individuals reporting to the system, to the extent permitted by law; andCommentsClose CommentsPermalink





(7) conduct other activities as requested by the Secretaries.CommentsClose CommentsPermalink