I 
110TH CONGRESS 
2D SESSION 
H. R. 6671 
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 
JULY 30, 2008 
Ms. HARMAN (for herself and Mr. ROGERS of Michigan) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committees on Agriculture and the Judici-
ary, 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 Bioter-
rorism Protection Act of 2002 and to improve oversight 
of high containment laboratories. 
Be it enacted by the Senate and House of Representa-
tives 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’’. 
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(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 Pre-
vention 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. 
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(4) As of April 2008, there are 325 entities reg-
istered 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 individ-
uals approved to work with select agents and toxins 
through the Centers for Disease Control and Preven-
tion and 4,336 through the Animal and Plant 
Health Inspection Service. 
(5) Biocontainment laboratories are used by sci-
entists to study infectious materials safely and effec-
tively. 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 PRO-
GRAM.— 
(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’’. 
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(2) AMENDMENT TO THE AGRICULTURAL BIO-
TERRORISM
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 BIO-
TERRORISM
PROTECTION
ACT
OF
2002.—Section 
212(e)(2)(A) of the Agricultural Bioterrorism Pro-
tection 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,’’. 
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(2) AMENDMENT TO THE AGRICULTURAL BIO-
TERRORISM
PROTECTION
ACT
OF
2002.—Section 
212(h)(2)(A) of the Agricultural Bioterrorism Pro-
tection 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 Ag-
riculture, 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 Agri-
cultural Bioterrorism Protection Act of 2002 (7 U.S.C. 
8401). Such review shall focus on— 
(1) the extent to which the program has en-
hanced 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 
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(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 Na-
tional 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 En-
ergy 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. 
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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 sub-
clause (VII); and 
(3) by inserting after subclause (III) the fol-
lowing: 
‘‘(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 Se-
curity; 
‘‘(VI) newly discovered agents of 
disease, including genetically modified 
organisms or agents created syn-
thetically; and’’. 
(b) AMENDMENT TO THE AGRICULTURAL BIOTER-
RORISM
PROTECTION
ACT
OF
2002.—Section 
212(a)(1)(B)(i) of the Agricultural Bioterrorism Protec-
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