II 

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. 

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 2008’’. 

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

8 this Act is as follows: 


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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. 

1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) The Centers for Disease Control and Pre4 vention regulates the possession, use, and transfer of 

5 select agents and toxins that have the potential to 

6 pose a severe threat to public health and safety. 

7 (2) The Animal and Plant Health Inspection 

8 Service regulates the possession, use, and transfer of 

9 select agents and toxins that have the potential to 

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

11 animal or plant products. 

12 (3) As of April 2008, there are 72 select agents 

13 and toxins, 13 of which are found naturally in the 

14 United States. 

15 (4) As of April 2008, there are 325 entities reg16 istered with the Centers for Disease Control and 

17 Prevention to work with select agents and toxins and 


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1 75 entities registered with the Animal and Plant 

2 Health Inspection Service. There are 9,918 individ3 uals approved to work with select agents and toxins 

4 through the Centers for Disease Control and Preven5 tion and 4,336 through the Animal and Plant 

6 Health Inspection Service. 

7 (5) Biocontainment laboratories are used by sci8 entists to study infectious materials safely and effec9 tively. Laboratory biological research is categorized 

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

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

12 through 4. 

13 TITLE I—SELECT AGENT 

14 PROGRAM REAUTHORIZATION 

15 SEC. 101. REAUTHORIZATION OF SELECT AGENT PROGRAM. 

16 (a) REAUTHORIZATION OF SELECT AGENT PRO17 GRAM.— 

18 (1) AMENDMENT TO THE PUBLIC HEALTH

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

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

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

22 ‘‘2009 through 2013’’. 

23 (2) AMENDMENT TO THE AGRICULTURAL BIO24 TERRORISM PROTECTION ACT OF 2002.—Section 

25 212(m) of the Agricultural Bioterrorism Protection 


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

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

3 through 2013’’. 

4 (b) APPROPRIATE TRAINING.— 

5 (1) AMENDMENT TO THE PUBLIC HEALTH

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

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

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

9 after ‘‘have a legitimate need’’. 

10 (2) AMENDMENT TO THE AGRICULTURAL BIO11 TERRORISM PROTECTION ACT OF 2002.—Section 

12 212(e)(2)(A) of the Agricultural Bioterrorism Pro13 tection Act of 2002 (7 U.S.C. 8401(e)(2)(A)) is 

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

15 after ‘‘have a legitimate need’’. 

16 (c) COVERED AGENCIES.— 

17 (1) AMENDMENT TO THE PUBLIC HEALTH

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

19 262a(h)(2)(A)) of the Public Health Service Act is 

20 amended by inserting ‘‘the Department of Homeland 

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

22 (2) AMENDMENT TO THE AGRICULTURAL BIO23 TERRORISM PROTECTION ACT OF 2002.—Section 

24 212(h)(2)(A) of the Agricultural Bioterrorism Pro25 tection Act of 2002 (7 U.S.C. 8401(h)(2)(A)) is 


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1 amended by inserting ‘‘the Department of Homeland 

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

3 SEC. 102. SELECT AGENT PROGRAM REVIEW. 

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

5 Human Services, in consultation with the Secretary of Ag6 riculture, shall enter into a contract with the National 

7 Academy of Sciences to conduct a review of the select 

8 agent program under section 351A of the Public Health 

9 Service Act (42 U.S.C. 262a) and section 212 of the Agri10 cultural Bioterrorism Protection Act of 2002 (7 U.S.C. 

11 8401). Such review shall focus on— 

12 (1) the extent to which the program has en13 hanced biosecurity and biosafety in the United 

14 States; 

15 (2) the effects of the program on— 

16 (A) international scientific collaboration; 

17 and 

18 (B) scientific advances in the United 

19 States; and 

20 (3) other issues as requested by the Secretary 

21 of Health and Human Services and the Secretary of 

22 Agriculture. 

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

24 240 days after the date of enactment of this Act, the Na25 tional Academy of Sciences shall submit a report to the 


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1 Secretary of Health and Human Services, the Secretary 

2 of Agriculture, the Committee on Health, Education, 

3 Labor, and Pensions of the Senate, the Committee on En4 ergy and Commerce of the House of Representatives, and 

5 other congressional committees of relevant interest, on the 

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

7 report shall include recommendations for improving the 

8 structure of the select agent program for— 

9 (1) enhancing the biosecurity and biosafety of 

10 the United States; 

11 (2) eliminating or reducing adverse effects of 

12 the program, if any, on— 

13 (A) international scientific collaboration; 

14 and 

15 (B) scientific advances in the United 

16 States; and 

17 (3) other issues as requested by the Secretary 

18 of Health and Human Services and the Secretary of 

19 Agriculture. 

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

21 AND TOXINS. 

22 (a) AMENDMENT TO THE PUBLIC HEALTH SERVICE

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

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


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

2 inserting a semicolon; 

3 (2) by redesignating subclause (IV) as sub4 clause (VII); and 

5 (3) by inserting after subclause (III) the fol6 lowing: 

7 ‘‘(IV) whether the agent or toxin 

8 is endemic to the United States, as 

9 defined by the Secretary; 

10 ‘‘(V) information available from 

11 biological risk assessments conducted 

12 by the Department of Homeland Se13 curity; 

14 ‘‘(VI) newly discovered agents of 

15 disease, including genetically modified 

16 organisms or agents created syn17 thetically; and’’. 

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

20 212(a)(1)(B)(i) of the Agricultural Bioterrorism Protec21 tion Act of 2002 (7 U.S.C. 8401(a)(1)(B)(i)) is amend22 ed— 

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

24 inserting a semicolon; 


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1 (2) by redesignating subclause (IV) as sub2 clause (VII); and 

3 (3) by inserting after subclause (III) the fol4 lowing: 

5 ‘‘(IV) whether the agent or toxin 

6 is endemic to the United States, as 

7 defined by the Secretary; 

8 ‘‘(V) information available from 

9 biological risk assessments conducted 

10 by the Department of Homeland Se11 curity; 

12 ‘‘(VI) newly discovered agents of 

13 disease, including genetically modified 

14 organisms or agents created syn15 thetically; and’’. 

16 (c) RULE OF CONSTRUCTION.—The amendments 

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

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

19 is endemic to the United States. 

20 SEC. 104. SHARING INFORMATION WITH TRUSTED STATE 

21 PARTNERS. 

22 (a) AMENDMENT TO THE PUBLIC HEALTH SERVICE

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

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


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

2 inserting a semicolon; 

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

4 and inserting ‘‘; or’’; and 

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

6 ‘‘(C) to withhold information regarding a 

7 State that will assist with the State’s emer8 gency preparedness planning from the health 

9 director (or equivalent State official) of such 

10 State, if such State has in place a law to pro11 tect against the further release of such informa12 tion as determined by the Secretary.’’. 

13 (b) AMENDMENT TO THE AGRICULTURAL BIOTER14 RORISM PROTECTION ACT OF 2002.—Section 212(h)(5) 

15 of the Agricultural Bioterrorism Protection Act of 2002 

16 (7 U.S.C. 8401(h)(5)) is amended— 

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

18 inserting a semicolon; 

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

20 and inserting ‘‘; or’’; and 

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

22 ‘‘(C) to withhold information regarding a 

23 State that will assist with the State’s emer24 gency preparedness planning from an elected or 

25 appointed senior State agricultural official or 


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1 equivalent State official (such as a State veteri2 narian or a State plant health regulatory offi3 cial) of such State, if such State has in place 

4 a law to protect against the further release of 

5 such information as determined by the Sec6 retary.’’. 

7 SEC. 105. IMPROVEMENTS TO INVENTORYING AND MONI8 TORING OF AGENTS. 

9 (a) IMPROVED METHOD TO INVENTORY AND MON10 ITOR LISTED BIOLOGICAL AGENTS.—Not later than 180 

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

12 and Human Services, in coordination with the Secretary 

13 of Agriculture, and in consultation with individuals with 

14 appropriate scientific expertise, shall issue guidance on 

15 inventorying and monitoring the biological agents listed 

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

17 (42 U.S.C. 262a(a)(1)) and the biological agents listed 

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

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

20 (b) CONSIDERATIONS.—In issuing the guidance 

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

22 (1) the effectiveness of measures to inventory 

23 and monitor listed biological agents that can propa24 gate relative to the burden of these measures on lab25 oratory personnel; 


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1 (2) qualitative and quantitative control proce2 dures for such listed agents, rather than only quan3 titative control procedures; and 

4 (3) in what situations registered persons are re5 quired to keep inventory records. 

6 SEC. 106. SMALLPOX DEFINITION CLARIFICATION. 

7 Not later than 90 days after the date of enactment 

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

9 Secretary of Health and Human Services, shall issue pub10 lic guidance regarding how the Attorney General inter11 prets the scope of the statutory definition of ‘‘variola 

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

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

14 AGENTS AND TOXINS. 

15 The Secretary of Health and Human Services, in co16 ordination with the Secretary of Agriculture and State of17 ficials, shall develop and disseminate guidelines for how 

18 laboratories and laboratory personnel that do not regularly 

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

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

21 U.S.C. 262a) and section 212 of the Agricultural Bioter22 rorism Protection Act of 2002 (7 U.S.C. 8401)) may be 

23 rapidly accessed and utilized during emergencies in which 

24 laboratories and laboratory personnel that regularly test 


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1 for such agents and toxins are overwhelmed by a surge 

2 of samples of such listed agents and toxins. 

3 TITLE II—BIOSAFETY 

4 IMPROVEMENTS 

5 SEC. 201. IMPROVEMENT OF OVERSIGHT OF BIOCONTAIN6 MENT LABORATORIES. 

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

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

9 laboratory that has Biosafety Level 3 or Biosafety Level 

10 4 facilities, as defined by the Secretary of Health and 

11 Human Services and the Secretary of Agriculture. 

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

13 Human Services, in coordination with the Secretary of Ag14 riculture, and in consultation with the Secretary of De15 fense and the Secretary of Homeland Security (referred 

16 to in this section as the ‘‘Secretaries’’) shall, either di17 rectly or through a contract, evaluate national needs of, 

18 and oversight of, high containment biological laboratories. 

19 (c) CONSIDERATIONS.—In conducting the evaluation 

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

21 (1) whether the construction of high contain22 ment biological laboratories that are in existence or 

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

24 likely to provide sufficient capacity for the needs of 


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1 Government biodefense and infectious disease re2 search; 

3 (2) how laboratory capacity and lessons learned 

4 can be best shared across the biodefense and infec5 tious disease research communities, domestically and 

6 internationally; 

7 (3) whether guidance on laboratory infrastruc8 ture, commissioning, operation, and maintenance of 

9 such laboratories is adequate, and if such guidance 

10 is found to be inadequate, how to improve and 

11 streamline such guidance; and 

12 (4) ways to improve and streamline the training 

13 of the personnel of such laboratories, including rec14 ommendations regarding the minimum standards for 

15 laboratory biosafety and biosecurity training under 

16 section 202. 

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

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

19 Health and Human Services shall submit to Congress a 

20 report on the findings and recommendations from the 

21 evaluation under this section. 

22 SEC. 202. IMPROVEMENT OF TRAINING FOR LABORATORY 

23 PERSONNEL. 

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

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


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1 laboratory that has Biosafety Level 3 or Biosafety Level 

2 4 facilities, as defined by the Secretary of Health and 

3 Human Services and the Secretary of Agriculture. 

4 (b) DEVELOPMENT OF MINIMUM STANDARDS.—The 

5 Secretary of Health and Human Services, acting through 

6 the Director of the Centers for Disease Control and Pre7 vention and the Director of the National Institutes of 

8 Health, and in coordination with the Secretary of Agri9 culture and scientific experts representing appropriate 

10 professional groups and international health organiza11 tions, shall develop minimum standards for laboratory bio12 safety and biosecurity training for relevant personnel of 

13 high containment biological laboratories. In developing 

14 such standards, the Secretary of Health and Human Serv15 ices shall consider existing laboratory guidelines and train16 ing modules. 

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

18 not register with the Secretary of Health and Human 

19 Services or the Secretary of Agriculture for the possession, 

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

21 351A of the Public Health Service Act (42 U.S.C. 262a) 

22 and section 212 of the Agricultural Bioterrorism Protec23 tion Act of 2002 (7 U.S.C. 8401) unless the person pro24 vides to its appropriate personnel biosafety and biosecurity 

25 training that meets the minimum standards under subVerDate Aug 31 2005 00:08 Jun 14, 2008 Jkt 069200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S3127.IS S3127

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1 section (b) in addition to any other requirements deter2 mined appropriate by the Secretary of Health and Human 

3 Services or the Secretary of Agriculture. 

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

5 Human Services, in coordination with the Secretary of Ag6 riculture, may disseminate the minimum standards under 

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

8 required under subsection (b), in laboratories and aca9 demic programs in the United States and in other coun10 tries. 

11 SEC. 203. BIOLOGICAL LABORATORY INCIDENT REPORTING 

12 SYSTEM. 

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

14 Human Services, in coordination with the Secretary of Ag15 riculture, (referred to in this section as the ‘‘Secretaries’’) 

16 shall establish an integrated Biological Laboratory Inci17 dent Reporting System through which personnel of biologi18 cal laboratories may voluntarily report biosafety or bio19 security incidents of concern and the Secretaries may 

20 identify trends in such incidents and protocols for bio21 safety or biosecurity improvements. In developing such re22 porting system, the Secretaries shall consider options for 

23 integrating existing voluntary and required reporting 

24 mechanisms. 


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1 (b) FUNCTIONS.—In implementing the reporting sys2 tem under subsection (a), the Secretaries shall enter into 

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

4 regulate biological laboratories to administer the reporting 

5 system. Such entity shall— 

6 (1) receive and process incident reports; 

7 (2) analyze, interpret incident data, and iden8 tify incident trends; 

9 (3) issue alert messages within an appropriate 

10 time period; 

11 (4) disseminate reports and other appropriate 

12 information, which shall not include facility-specific 

13 information; 

14 (5) not have authority to direct corrective ac15 tion or to initiate enforcement action; 

16 (6) ensure anonymity of individuals reporting to 

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

18 (7) conduct other activities as requested by the 

19 Secretaries. 

Æ 


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