I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Select Agent Program and Biosafety Improvement Act 

6 of 2009’’. 


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1 (b) TABLE OF CONTENTS.—The table of contents for 

2 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. 

3 SEC. 2. FINDINGS. 

4 Congress finds the following: 

5 (1) The Centers for Disease Control and Pre6 vention regulates the possession, use, and transfer of 

7 select agents and toxins that have the potential to 

8 pose a severe threat to public health and safety. 

9 (2) The Animal and Plant Health Inspection 

10 Service regulates the possession, use, and transfer of 

11 select agents and toxins that have the potential to 

12 pose a severe threat to animal or plant health, or to 

13 animal or plant products. 

14 (3) As of February 2009, there are 82 select 

15 agents and toxins, 13 of which are found naturally 

16 in the United States. 


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1 (4) As of February 2009, there are 336 entities 

2 registered with the Centers for Disease Control and 

3 Prevention to work with select agents and toxins and 

4 64 entities registered with the Animal and Plant 

5 Health Inspection Service. There are 10,463 individ6 uals approved to work with select agents and toxins 

7 through the Centers for Disease Control and Preven8 tion and 4,149 through the Animal and Plant 

9 Health Inspection Service. 

10 (5) Biocontainment laboratories are used by sci11 entists to study infectious materials safely and effec12 tively. Laboratory biological research is categorized 

13 by the safety level at which it is performed. There 

14 are 4 safety levels, termed Biosafety Level (BSL) 1 

15 through 4. 

16 TITLE I—SELECT AGENT 

17 PROGRAM REAUTHORIZATION 

18 SEC. 101. REAUTHORIZATION OF SELECT AGENT PROGRAM. 

19 (a) REAUTHORIZATION OF SELECT AGENT PRO20 GRAM.— 

21 (1) AMENDMENT TO THE PUBLIC HEALTH

22 SERVICE ACT.—Section 351A(m) of the Public 

23 Health Service Act (42 U.S.C. 262a(m)) is amended 

24 by striking ‘‘2002 through 2007’’ and inserting 

25 ‘‘2009 through 2013’’. 


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1 (2) AMENDMENT TO THE AGRICULTURAL BIO2 TERRORISM PROTECTION ACT OF 2002.—Section 

3 212(m) of the Agricultural Bioterrorism Protection 

4 Act of 2002 (7 U.S.C. 8401(m)) is amended by 

5 striking ‘‘2002 through 2007’’ and inserting ‘‘2009 

6 through 2013’’. 

7 (b) APPROPRIATE TRAINING.— 

8 (1) AMENDMENT TO THE PUBLIC HEALTH

9 SERVICE ACT.—Section 351A(e)(2)(A) of the Public 

10 Health Service Act (42 U.S.C. 262a(e)(2)(A)) is 

11 amended by inserting ‘‘, and appropriate training,’’ 

12 after ‘‘have a legitimate need’’. 

13 (2) AMENDMENT TO THE AGRICULTURAL BIO14 TERRORISM PROTECTION ACT OF 2002.—Section 

15 212(e)(2)(A) of the Agricultural Bioterrorism Pro16 tection Act of 2002 (7 U.S.C. 8401(e)(2)(A)) is 

17 amended by inserting ‘‘, and appropriate training,’’ 

18 after ‘‘have a legitimate need’’. 

19 (c) COVERED AGENCIES.— 

20 (1) AMENDMENT TO THE PUBLIC HEALTH

21 SERVICE ACT.—Section 351A(h)(2)(A) (42 U.S.C. 

22 262a(h)(2)(A)) of the Public Health Service Act is 

23 amended by inserting ‘‘the Department of Homeland 

24 Security,’’ after ‘‘the Department of Agriculture,’’. 


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1 (2) AMENDMENT TO THE AGRICULTURAL BIO2 TERRORISM PROTECTION ACT OF 2002.—Section 

3 212(h)(2)(A) of the Agricultural Bioterrorism Pro4 tection Act of 2002 (7 U.S.C. 8401(h)(2)(A)) is 

5 amended by inserting ‘‘the Department of Homeland 

6 Security,’’ after ‘‘the Department of Agriculture,’’. 

7 SEC. 102. SELECT AGENT PROGRAM REVIEW. 

8 (a) IN GENERAL.—The Secretary of Health and 

9 Human Services, in consultation with the Secretary of Ag10 riculture, shall enter into a contract with the National 

11 Academy of Sciences to conduct a review of the select 

12 agent program under section 351A of the Public Health 

13 Service Act (42 U.S.C. 262a) and section 212 of the Agri14 cultural Bioterrorism Protection Act of 2002 (7 U.S.C. 

15 8401). Such review shall focus on— 

16 (1) the extent to which the program has en17 hanced biosecurity and biosafety in the United 

18 States; 

19 (2) the effects of the program on— 

20 (A) international scientific collaboration; 

21 and 

22 (B) scientific advances in the United 

23 States; and 


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1 (3) other issues as requested by the Secretary 

2 of Health and Human Services and the Secretary of 

3 Agriculture. 

4 (b) REPORT; RECOMMENDATIONS.—Not later than 

5 240 days after the date of enactment of this Act, the Na6 tional Academy of Sciences shall submit a report to the 

7 Secretary of Health and Human Services, the Secretary 

8 of Agriculture, the Committee on Health, Education, 

9 Labor, and Pensions of the Senate, the Committee on En10 ergy and Commerce of the House of Representatives, and 

11 other congressional committees of relevant interest, on the 

12 results of the review conducted under subsection (a). Such 

13 report shall include recommendations for improving the 

14 structure of the select agent program for— 

15 (1) enhancing the biosecurity and biosafety of 

16 the United States; 

17 (2) eliminating or reducing adverse effects of 

18 the program, if any, on— 

19 (A) international scientific collaboration; 

20 and 

21 (B) scientific advances in the United 

22 States; and 

23 (3) other issues as requested by the Secretary 

24 of Health and Human Services and the Secretary of 

25 Agriculture. 


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1 SEC. 103. REVISION OF THE LIST OF BIOLOGICAL AGENTS 

2 AND TOXINS. 

3 (a) AMENDMENT TO THE PUBLIC HEALTH SERVICE

4 ACT.—Section 351A(a)(1)(B)(i) of the Public Health 

5 Service Act (42 U.S.C. 262a(a)(1)(B)(i)) is amended— 

6 (1) in subclause (III), by striking ‘‘; and’’ and 

7 inserting a semicolon; 

8 (2) by redesignating subclause (IV) as sub9 clause (VII); and 

10 (3) by inserting after subclause (III) the fol11 lowing: 

12 ‘‘(IV) whether the agent or toxin 

13 is endemic to the United States, as 

14 defined by the Secretary; 

15 ‘‘(V) information available from 

16 biological risk assessments conducted 

17 by the Department of Homeland Se18 curity; 

19 ‘‘(VI) newly discovered agents of 

20 disease, including genetically modified 

21 organisms or agents created syn22 thetically; and’’. 

23 (b) AMENDMENT TO THE AGRICULTURAL BIOTER24 RORISM PROTECTION ACT OF 2002.—Section 

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1 tion Act of 2002 (7 U.S.C. 8401(a)(1)(B)(i)) is amend2 ed— 

3 (1) in subclause (III), by striking ‘‘; and’’ and 

4 inserting a semicolon; 

5 (2) by redesignating subclause (IV) as sub6 clause (VII); and 

7 (3) by inserting after subclause (III) the fol8 lowing: 

9 ‘‘(IV) whether the agent or toxin 

10 is endemic to the United States, as 

11 defined by the Secretary; 

12 ‘‘(V) information available from 

13 biological risk assessments conducted 

14 by the Department of Homeland Se15 curity; 

16 ‘‘(VI) newly discovered agents of 

17 disease, including genetically modified 

18 organisms or agents created syn19 thetically; and’’. 

20 (c) RULE OF CONSTRUCTION.—The amendments 

21 made by subsections (a) and (b) shall not be construed 

22 to preclude the listing of a biological agent or toxin that 

23 is endemic to the United States. 


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1 SEC. 104. SHARING INFORMATION WITH TRUSTED STATE 

2 PARTNERS. 

3 (a) AMENDMENT TO THE PUBLIC HEALTH SERVICE

4 ACT.—Section 351A(h)(5) of the Public Health Service 

5 Act (42 U.S.C. 262a(h)(5)) is amended— 

6 (1) in subparagraph (A), by striking ‘‘; or’’ and 

7 inserting a semicolon; 

8 (2) in subparagraph (B), by striking the period 

9 and inserting ‘‘; or’’; and 

10 (3) by inserting at the end the following: 

11 ‘‘(C) to withhold information regarding a 

12 State that will assist with the State’s emer13 gency preparedness planning from the health 

14 director (or equivalent State official) of such 

15 State, if such State has in place a law to pro16 tect against the further release of such informa17 tion as determined by the Secretary.’’. 

18 (b) AMENDMENT TO THE AGRICULTURAL BIOTER19 RORISM PROTECTION ACT OF 2002.—Section 212(h)(5) 

20 of the Agricultural Bioterrorism Protection Act of 2002 

21 (7 U.S.C. 8401(h)(5)) is amended— 

22 (1) in subparagraph (A), by striking ‘‘; or’’ and 

23 inserting a semicolon; 

24 (2) in subparagraph (B), by striking the period 

25 and inserting ‘‘; or’’; and 

26 (3) by inserting at the end the following: 


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1 ‘‘(C) to withhold information regarding a 

2 State that will assist with the State’s emer3 gency preparedness planning from an elected or 

4 appointed senior State agricultural official or 

5 equivalent State official (such as a State veteri6 narian or a State plant health regulatory offi7 cial) of such State, if such State has in place 

8 a law to protect against the further release of 

9 such information as determined by the Sec10 retary.’’. 

11 SEC. 105. IMPROVEMENTS TO INVENTORYING AND MONI12 TORING OF AGENTS. 

13 (a) IMPROVED METHOD TO INVENTORY AND MON14 ITOR LISTED BIOLOGICAL AGENTS.—Not later than 180 

15 days after enactment of this Act, the Secretary of Health 

16 and Human Services, in coordination with the Secretary 

17 of Agriculture, and in consultation with individuals with 

18 appropriate scientific expertise, shall issue guidance on 

19 inventorying and monitoring the biological agents listed 

20 under section 351A(a)(1) of the Public Health Service Act 

21 (42 U.S.C. 262a(a)(1)) and the biological agents listed 

22 under section 212(a)(1) of the Agricultural Bioterrorism 

23 Protection Act of 2002 (7 U.S.C. 8401(a)(1)). 

24 (b) CONSIDERATIONS.—In issuing the guidance 

25 under subsection (a), the Secretaries shall consider— 


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1 (1) the effectiveness of measures to inventory 

2 and monitor listed biological agents that can propa3 gate relative to the burden of these measures on lab4 oratory personnel; 

5 (2) qualitative and quantitative control proce6 dures for such listed agents, rather than only quan7 titative control procedures; and 

8 (3) in what situations registered persons are re9 quired to keep inventory records. 

10 SEC. 106. SMALLPOX DEFINITION CLARIFICATION. 

11 Not later than 90 days after the date of enactment 

12 of this Act, the Attorney General, in coordination with the 

13 Secretary of Health and Human Services, shall issue pub14 lic guidance regarding how the Attorney General inter15 prets the scope of the statutory definition of ‘‘variola 

16 virus’’ in section 175c of title 18, United States Code. 

17 SEC. 107. PLAN FOR SURGE IN SAMPLES OF BIOLOGICAL 

18 AGENTS AND TOXINS. 

19 The Secretary of Health and Human Services, in co20 ordination with the Secretary of Agriculture and State of21 ficials, shall develop and disseminate guidelines for how 

22 laboratories and laboratory personnel that do not regularly 

23 test for listed agents and toxins (as such terms are defined 

24 in section 351A of the Public Health Service Act (42 

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1 rorism Protection Act of 2002 (7 U.S.C. 8401)) may be 

2 rapidly accessed and utilized during emergencies in which 

3 laboratories and laboratory personnel that regularly test 

4 for such agents and toxins are overwhelmed by a surge 

5 of samples of such listed agents and toxins. 

6 TITLE II—BIOSAFETY 

7 IMPROVEMENTS 

8 SEC. 201. IMPROVEMENT OF OVERSIGHT OF BIOCONTAIN9 MENT LABORATORIES. 

10 (a) DEFINITION.—For purposes of this section, the 

11 term ‘‘high containment biological laboratory’’ means a 

12 laboratory that has Biosafety Level 3 or Biosafety Level 

13 4 facilities, as defined by the Secretary of Health and 

14 Human Services and the Secretary of Agriculture. 

15 (b) EVALUATION.—The Secretary of Health and 

16 Human Services, in coordination with the Secretary of Ag17 riculture, and in consultation with the Secretary of De18 fense and the Secretary of Homeland Security (referred 

19 to in this section as the ‘‘Secretaries’’) shall, either di20 rectly or through a contract, evaluate national needs of, 

21 and oversight of, high containment biological laboratories. 

22 (c) CONSIDERATIONS.—In conducting the evaluation 

23 under subsection (b), the Secretaries shall consider— 

24 (1) whether the construction of high contain25 ment biological laboratories that are in existence or 


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1 planned as of the date of enactment of this Act, is 

2 likely to provide sufficient capacity for the needs of 

3 Government biodefense and infectious disease re4 search; 

5 (2) how laboratory capacity and lessons learned 

6 can be best shared across the biodefense and infec7 tious disease research communities, domestically and 

8 internationally; 

9 (3) whether guidance on laboratory infrastruc10 ture, commissioning, operation, and maintenance of 

11 such laboratories is adequate, and if such guidance 

12 is found to be inadequate, how to improve and 

13 streamline such guidance; and 

14 (4) ways to improve and streamline the training 

15 of the personnel of such laboratories, including rec16 ommendations regarding the minimum standards for 

17 laboratory biosafety and biosecurity training under 

18 section 202. 

19 (d) REPORT TO CONGRESS.—Not later than 240 days 

20 after the date of enactment of this Act, the Secretary of 

21 Health and Human Services shall submit to Congress a 

22 report on the findings and recommendations from the 

23 evaluation under this section. 


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1 SEC. 202. IMPROVEMENT OF TRAINING FOR LABORATORY 

2 PERSONNEL. 

3 (a) DEFINITION.—For purposes of this section, the 

4 term ‘‘high containment biological laboratory’’ means a 

5 laboratory that has Biosafety Level 3 or Biosafety Level 

6 4 facilities, as defined by the Secretary of Health and 

7 Human Services and the Secretary of Agriculture. 

8 (b) DEVELOPMENT OF MINIMUM STANDARDS.—The 

9 Secretary of Health and Human Services, acting through 

10 the Director of the Centers for Disease Control and Pre11 vention and the Director of the National Institutes of 

12 Health, and in coordination with the Secretary of Agri13 culture and scientific experts representing appropriate 

14 professional groups and international health organiza15 tions, shall develop minimum standards for laboratory bio16 safety and biosecurity training for relevant personnel of 

17 high containment biological laboratories. In developing 

18 such standards, the Secretary of Health and Human Serv19 ices shall consider existing laboratory guidelines and train20 ing modules. 

21 (c) REQUIREMENT FOR APPROVAL.—A person may 

22 not register with the Secretary of Health and Human 

23 Services or the Secretary of Agriculture for the possession, 

24 use, or transfer of listed agents in accordance with section 

25 351A of the Public Health Service Act (42 U.S.C. 262a) 

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1 tion Act of 2002 (7 U.S.C. 8401) unless the person pro2 vides to its appropriate personnel biosafety and biosecurity 

3 training that meets the minimum standards under sub4 section (b) in addition to any other requirements deter5 mined appropriate by the Secretary of Health and Human 

6 Services or the Secretary of Agriculture. 

7 (d) DISSEMINATION.—The Secretary of Health and 

8 Human Services, in coordination with the Secretary of Ag9 riculture, may disseminate the minimum standards under 

10 subsection (b) for voluntary use, such as when use is not 

11 required under subsection (b), in laboratories and aca12 demic programs in the United States and in other coun13 tries. 

14 SEC. 203. BIOLOGICAL LABORATORY INCIDENT REPORTING 

15 SYSTEM. 

16 (a) IN GENERAL.—The Secretary of Health and 

17 Human Services, in coordination with the Secretary of Ag18 riculture, (referred to in this section as the ‘‘Secretaries’’) 

19 shall establish an integrated Biological Laboratory Inci20 dent Reporting System through which personnel of biologi21 cal laboratories may voluntarily report biosafety or bio22 security incidents of concern and the Secretaries may 

23 identify trends in such incidents and protocols for bio24 safety or biosecurity improvements. In developing such re25 porting system, the Secretaries shall consider options for 


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1 integrating existing voluntary and required reporting 

2 mechanisms. 

3 (b) FUNCTIONS.—In implementing the reporting sys4 tem under subsection (a), the Secretaries shall enter into 

5 a contract with a public or private entity that does not 

6 regulate biological laboratories to administer the reporting 

7 system. Such entity shall— 

8 (1) receive and process incident reports; 

9 (2) analyze, interpret incident data, and iden10 tify incident trends; 

11 (3) issue alert messages within an appropriate 

12 time period; 

13 (4) disseminate reports and other appropriate 

14 information, which shall not include facility-specific 

15 information; 

16 (5) not have authority to direct corrective ac17 tion or to initiate enforcement action; 

18 (6) ensure anonymity of individuals reporting to 

19 the system, to the extent permitted by law; and 

20 (7) conduct other activities as requested by the 

21 Secretaries. 

Æ 


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