I
107TH CONGRESS
1ST SESSION
H. R. 3306
To set up a certification system for research facilities that possess dangerous
biological agents and toxins, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
NOVEMBER 15, 2001
Mr. SCHIFF introduced the following bill; which was referred to the Committee
on Energy and Commerce, and in addition to the Committee on the Judi-
ciary, 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 set up a certification system for research facilities that
possess dangerous biological agents and toxins, and for
other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Deadly Biological
Agent Control Act of 2001’’.
SEC. 2. BIOLOGICAL WEAPONS.
(a) SELECT AGENTS.—Section 175 of title 18,
United States Code, is amended by striking subsection (b)
and inserting the following:
‘‘(b) SELECT AGENTS.—
‘‘(1) 
UNCERTIFIED
POSSESSION.—Whoever
knowingly possesses a select agent without obtaining
a certification from the Department of Health and
Human Services under section 511(f) of the
Antiterrorism and Effective Death Penalty Act of
1996, shall be fined under this title, imprisoned for
not more than 5 years, or both.
‘‘(2) TRANSFER
TO
UNCERTIFIED
PERSON.—
Any research facility that knowingly transfers a se-
lect agent to an entity that has not obtained a cer-
tification from the Department of Health and
Human Services under section 511(f) of the
Antiterrorism and Effective Death Penalty Act of
1996, shall be fined under this title, imprisoned for
not more than 5 years, or both.
‘‘(c) DEFINITIONS.—In this section:
‘‘(1) BIOLOGICAL AGENT; TOXIN.—The terms
‘biological agent’ and ‘toxin’ have the same mean-
ings given those terms in section 178, except that,
for purposes of subsection (b), if the biological agent
or toxin has not been cultivated, cultured, collected,
or otherwise extracted from its natural source, those
terms do not include any biological agent or toxin
that is in its naturally occurring environment.
‘‘(2) FOR USE AS A WEAPON.—The term ‘for
use as a weapon’ includes the development, produc-
tion, transfer, acquisition, retention, or possession of
any biological agent, toxin, or delivery system, other
than for prophylactic, protective, or other peaceful
purposes.
‘‘(3) SELECT AGENT.—The term ‘select agent’
means a biological agent or toxin that—
‘‘(A) is included on the list established
under section 511(d)(1) of the Antiterrorism
and Effective Death Penalty Act of 1996; and
‘‘(B) is not possessed by a health, re-
search, or other entity listed under subpara-
graph (C) or (D) of section 511(f)(2) of that
Act.’’.
(b) LIST OF BIOLOGICAL TOXINS.—Section 511(d)
of the Antiterrorism and Effective Death Penalty Act of
1996 (42 U.S.C. 262 note) is amended to read as follows:
‘‘(d) 
REGULATORY
CONTROL
OF
BIOLOGICAL
AGENTS.—
‘‘(1) LIST OF BIOLOGICAL AGENTS AND TOX-
INS.—The Secretary, in consultation with the Sec-
retary of Defense, Attorney General, and other ap-
propriate Federal officials, shall—
‘‘(A) annually review the existing list of se-
lect agents; and
‘‘(B) if necessary, revise that existing list
of select agents.
‘‘(2) CRITERIA.—In determining whether to in-
clude a biological agent or toxin on the list estab-
lished under paragraph (1), the Secretary shall—
‘‘(A) consider—
‘‘(i) the effect on human health of ex-
posure to each biological agent or toxin;
‘‘(ii) the degree of contagiousness of
each biological agent or toxin and the
methods by which each biological agent or
toxin is transferred to humans;
‘‘(iii) the availability and effectiveness
of vaccines and therapies to treat or pre-
vent any illness resulting from infection by
or exposure to each biological agent or
toxin;
‘‘(iv) the potential use of each biologi-
cal agent or toxin in a bioterrorist attack
on the civilian population; and
‘‘(v) any other criteria that the Sec-
retary considers appropriate; and
‘‘(B) consult with scientific experts who
represent appropriate professional groups.
‘‘(3) 
PRIORITIZATION
OF
COUNTER-
MEASURES.—The Secretary shall prioritize counter-
measures, including vaccines, therapies, medical de-
vices, and diagnostic tests which must be developed,
produced, or obtained in preparation for a bioter-
rorist attack or other significant disease emergency
in order to treat, prevent, or identify infection by, or
exposure to, biological agents and toxins, listed pur-
suant to this subsection.’’.
(c) REGULATION OF POSSESSION OF BIOLOGICAL
AGENTS
AND
TOXINS.—Section 
511(f) 
of 
the
Antiterrorism and Effective Death Penalty Act of 1996
(42 U.S.C. 262 note) is amended to read as follows:
‘‘(f) POSSESSION AND USE OF LISTED BIOLOGICAL
AGENTS AND TOXINS.—
‘‘(1) STANDARDS AND PROCEDURES.—The Sec-
retary shall provide for the establishment and en-
forcement of standards and procedures governing
the possession and use of biological agents and tox-
ins listed pursuant to subsection (d)(1), in order to
protect the health and safety of the public, including
safeguards to prevent access to those biological
agents and toxins for use in domestic or inter-
national terrorism, or for any other criminal pur-
pose.
‘‘(2) CERTIFICATION.—
‘‘(A) IN
GENERAL.—The Secretary shall
establish a certification process for the posses-
sion and use of biological agents and toxins list-
ed pursuant to subsection (d)(1).
‘‘(B) POSSESSION.—Except as provided in
subparagraph (C), the certification process es-
tablished under subparagraph (A) shall prohibit
any individual from knowingly possessing bio-
logical agents or toxins listed pursuant to sub-
section (d)(1).
‘‘(C) EXCEPTION.—A health, research, or
other entity may possess a biological toxin or
agent listed pursuant to subsection (d)(1), if
that entity is described in subparagraph (D) or
(E).
‘‘(D) LEGITIMATE
PURPOSE.—A health,
research, or other entity is described in this
subparagraph, if—