‘‘(i) the health, research, or other en-
tity is certified as legitimate by the De-
partment of Health and Human Services;
‘‘(ii) the research facility has a legiti-
mate research or other peaceful purpose
for possessing the biological agent or toxin;
‘‘(iii) the research facility submits to
periodic site inspections; and
‘‘(iv) the health, research, or other en-
tity demonstrates the establishment and
enforcement of safety procedures for the
possession of biological agents or toxins
listed pursuant to subsection (d), including
measures to ensure—
‘‘(I) proper training and appro-
priate skills for handling the biological
agents and toxins;
‘‘(II) proper laboratory facilities
to contain and dispose of the biologi-
cal agents and toxins; and
‘‘(III) safeguards to prevent ac-
cess to the biological agents and tox-
ins for use in domestic or inter-
national terrorism, or for any other
criminal purpose.
‘‘(E) DIAGNOSTIC OR VERIFICATION PUR-
POSE.—A health, research, or other entity is
described in this subparagraph, if the entity—
‘‘(i) possesses the biological agent or
toxin as part of a clinical specimen in-
tended for diagnostic or verification pur-
poses;
‘‘(ii) transfers the biological agent or
toxin to another entity that is certified
under this subsection, or disposes of the bi-
ological agent or toxin within 72 hours in
accordance with section 72.6(i) of title 42,
Code of Federal Regulations; and
‘‘(iii) reports the presence of the bio-
logical agent or toxin to the Centers for
Disease Control.
‘‘(3) RESEARCH FACILITIES.—
‘‘(A) IN
GENERAL.—Any individual who
handles biological agents or toxins in an entity
certified under this subsection shall—
‘‘(i) pass a criminal background
check, which shall include a determination
of whether that individual is a restricted
person (as that term is defined in section
175b of title 18, United States Code); and
‘‘(ii) be registered with the Depart-
ment of Health and Human Services for
the specific research project that requires
the use of biological agents or toxins.
‘‘(B) PENALTIES.—
‘‘(i) RESEARCH FACILITIES.—Any en-
tity that is certified under this subsection
and permits a restricted person, as that
term is defined in section 175b of title 18,
United States Code, to handle or access bi-
ological agents or toxins may be subject to
decertification by the Department of
Health and Human Services and civil pen-
alties in an amount not to exceed
$500,000.
‘‘(ii) SUPERVISORY PERSONNEL.—Su-
pervisory personnel in an entity that is cer-
tified under this subsection, who knowingly
permit a restricted person, as that term is
defined in section 175b of title 18, United
States Code, to handle or access biological
agents or toxins shall be subject to civil
penalties in an amount not to exceed
$250,000 and shall be imprisoned for not
more than 1 year.’’.
(d) 
CIVIL
PENALTIES.—Section 
511 
of 
the
Antiterrorism and Effective Death Penalty Act of 1996
(42 U.S.C. 262 note) is amended by—
(1) redesignating subsection (g) as subsection
(h); and
(2) inserting after subsection (f) the following:
‘‘(g) CIVIL PENALTY.—A person who violates sub-
section (e) or (f) shall be subject to the United States for
a civil penalty in an amount not to exceed $250,000 in
the case of an individual and $500,000 in the case of an
entity certified under subsection (f).’’.
(e) SECTION 511.—
(1) 
IN
GENERAL.—Section 
511 
of 
the
Antiterrorism and Effective Death Penalty Act of
1996 (42 U.S.C. 262 note) is amended—
(A) in subsection (e)—
(i) by inserting ‘‘and toxins’’ after
‘‘agents’’ each place that term appears;
and
(ii) by inserting ‘‘or toxin’’ after
‘‘agent’’ each place that term appears; and
(B) in subsection (h)(1), as redesignated
by this Act, by striking ‘‘the term ‘biological
agent’ has’’ and inserting ‘‘the terms ‘biological
agent’ and ‘toxin’ have’’.
(2) EFFECTIVE DATE.—The amendments made
by this subsection shall be deemed to have the same
effective date as section 511 of the Antiterrorism
and Effective Death Penalty Act of 1996 (42 U.S.C.
262 note).
(f) CONFORMING AMENDMENTS.—Section 511(e) of
the Antiterrorism and Effective Death Penalty Act of
1996 (42 U.S.C. 262 note) is amended—
(1) in the matter preceding paragraph (1), by
striking ‘‘, through regulation promulgated under
subsection (f),’’; and
(2) in the heading, by striking ‘‘AGENTS’’ and
inserting ‘‘AGENTS AND TOXINS’’.
SEC. 3. INTERIM RULE.
(a) IN GENERAL.—Not later than 30 days after the
date of enactment of this Act, the Secretary of Health and
Human Services shall promulgate an interim final rule for
carrying out section 511(d) of the Antiterrorism and Ef-
fective Death Penalty Act of 1996 (42 U.S.C. 262 note),
as amended by this Act.
(b) EFFECTIVE DATE.—The interim final rule pro-
mulgated under subsection (a) shall take effect 60 days
after the date on which the rule is promulgated, including
for purposes of—
(1) section 175(b)(1) of title 18, United States
Code (relating to criminal penalties), as added by
this Act; and
(2) section 511(g) of the Antiterrorism and Ef-
fective Death Penalty Act of 1996 (relating to civil
penalties), as added by this Act.
SEC. 4. REGISTRATION OF BIOLOGICAL AGENTS AND TOX-
INS.
In the case of a research facility that, as of the date
of enactment of this Act, is in possession of a biological
agent or toxin that is listed pursuant to section 511(d)
of the Antiterrorism and Effective Death Penalty Act of
1996, as amended by this Act, that research facility shall,
in accordance with the interim final rule promulgated
under section 3, submit an application for certification
under section 511(f) of the Antiterrorism and Effective
Death Penalty Act of 1996, not later than 30 days after
the date on which the rule is promulgated.
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