H. R. 3448—49
disclose to the public any information that under sub-
section (h) shall not be disclosed under section 552
of title 5, United States Code.
‘‘(8) NOTIFICATIONS REGARDING THEFT OR LOSS OF AGENTS.—
Requirements under paragraph (1) shall include the prompt
notification of the Secretary, and appropriate Federal, State,
and local law enforcement agencies, of the theft or loss of
listed agents and toxins.
‘‘(9) TECHNICAL
ASSISTANCE
FOR
REGISTERED
PERSONS.—
The Secretary, in consultation with the Attorney General, may
provide technical assistance to registered persons to improve
security of the facilities of such persons.
‘‘(f) INSPECTIONS.—The Secretary shall have the authority to
inspect persons subject to regulations under subsection (b) or (c)
to ensure their compliance with such regulations, including prohibi-
tions on restricted persons and other provisions of subsection (e).
‘‘(g) EXEMPTIONS.—
‘‘(1) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regulations
under subsections (b) and (c) shall exempt clinical or diagnostic
laboratories and other persons who possess, use, or transfer
listed agents or toxins that are contained in specimens pre-
sented for diagnosis, verification, or proficiency testing, pro-
vided that—
‘‘(A) the identification of such agents or toxins is
reported to the Secretary, and when required under Fed-
eral, State, or local law, to other appropriate authorities;
and
‘‘(B) such agents or toxins are transferred or destroyed
in a manner set forth by the Secretary by regulation.
‘‘(2) PRODUCTS.—
‘‘(A) IN GENERAL.—Regulations under subsections (b)
and (c) shall exempt products that are, bear, or contain
listed agents or toxins and are cleared, approved, licensed,
or registered under any of the Acts specified in subpara-
graph (B), unless the Secretary by order determines that
applying additional regulation under subsection (b) or (c)
to a specific product is necessary to protect public health
and safety.
‘‘(B) RELEVANT LAWS.—For purposes of subparagraph
(A), the Acts specified in this subparagraph are the fol-
lowing:
‘‘(i) The Federal Food, Drug, and Cosmetic Act.
‘‘(ii) Section 351 of this Act.
‘‘(iii) The Act commonly known as the Virus-
Serum-Toxin Act (the eighth paragraph under the
heading ‘Bureau of Animal Industry’ in the Act of
March 4, 1913; 21 U.S.C. 151–159).
‘‘(iv) The Federal Insecticide, Fungicide, and
Rodenticide Act.
‘‘(C) INVESTIGATIONAL USE.—
‘‘(i) IN GENERAL.—The Secretary may exempt an
investigational product that is, bears, or contains a
listed agent or toxin from the applicability of provisions
of regulations under subsection (b) or (c) when such
product is being used in an investigation authorized
under any Federal Act and the Secretary determines
that applying additional regulation under subsection
H. R. 3448—50
(b) or (c) to such product is not necessary to protect
public health and safety.
‘‘(ii) CERTAIN PROCESSES.—Regulations under sub-
sections (b) and (c) shall set forth the procedures for
applying for an exemption under clause (i). In the
case of investigational products authorized under any
of the Acts specified in subparagraph (B), the Secretary
shall make a determination regarding a request for
an exemption not later than 14 days after the first
date on which both of the following conditions have
been met by the person requesting the exemption:
‘‘(I) The person has submitted to the Secretary
an application for the exemption meeting the
requirements established by the Secretary.
‘‘(II) The person has notified the Secretary
that the investigation has been authorized under
such an Act.
‘‘(3) PUBLIC
HEALTH
EMERGENCIES.—The Secretary may
temporarily exempt a person from the applicability of the
requirements of this section, in whole or in part, if the Secretary
determines that such exemption is necessary to provide for
the timely participation of the person in a response to a
domestic or foreign public health emergency (whether deter-
mined under section 319(a) or otherwise) that involves a listed
agent or toxin. With respect to the emergency involved, such
exemption for a person may not exceed 30 days, except that
the Secretary, after review of whether such exemption remains
necessary, may provide one extension of an additional 30 days.
‘‘(4) AGRICULTURAL
EMERGENCIES.—Upon request of the
Secretary of Agriculture, after the granting by such Secretary
of an exemption under section 212(g)(1)(D) of the Agricultural
Bioterrorism Protection Act of 2002 pursuant to a finding that
there is an agricultural emergency, the Secretary of Health
and Human Services may temporarily exempt a person from
the applicability of the requirements of this section, in whole
or in part, to provide for the timely participation of the person
in a response to the agricultural emergency. With respect to
the emergency involved, the exemption under this paragraph
for a person may not exceed 30 days, except that upon request
of the Secretary of Agriculture, the Secretary of Health and
Human Services may, after review of whether such exemption
remains necessary, provide one extension of an additional 30
days.
‘‘(h) DISCLOSURE OF INFORMATION.—
‘‘(1) NONDISCLOSURE OF CERTAIN INFORMATION.—No Fed-
eral agency specified in paragraph (2) shall disclose under
section 552 of title 5, United States Code, any of the following:
‘‘(A) Any registration or transfer documentation sub-
mitted under subsections (b) and (c) for the possession,
use, or transfer of a listed agent or toxin; or information
derived therefrom to the extent that it identifies the listed
agent or toxin possessed, used, or transferred by a specific
registered person or discloses the identity or location of
a specific registered person.
‘‘(B) The national database developed pursuant to sub-
section (d), or any other compilation of the registration
or transfer information submitted under subsections (b)
H. R. 3448—51
and (c) to the extent that such compilation discloses site-
specific registration or transfer information.
‘‘(C) Any portion of a record that discloses the site-
specific or transfer-specific safeguard and security meas-
ures used by a registered person to prevent unauthorized
access to listed agents and toxins.
‘‘(D) Any notification of a release of a listed agent
or toxin submitted under subsections (b) and (c), or any
notification of theft or loss submitted under such sub-
sections.
‘‘(E) Any portion of an evaluation or report of an inspec-
tion of a specific registered person conducted under sub-
section (f) that identifies the listed agent or toxin possessed
by a specific registered person or that discloses the identity
or location of a specific registered person if the agency
determines that public disclosure of the information would
endanger public health or safety.
‘‘(2) COVERED AGENCIES.—For purposes of paragraph (1)
only, the Federal agencies specified in this paragraph are the
following:
‘‘(A) The Department of Health and Human Services,
the Department of Justice, the Department of Agriculture,
and the Department of Transportation.
‘‘(B) Any Federal agency to which information specified
in paragraph (1) is transferred by any agency specified
in subparagraph (A) of this paragraph.
‘‘(C) Any Federal agency that is a registered person,
or has a sub-agency component that is a registered person.
‘‘(D) Any Federal agency that awards grants or enters
into contracts or cooperative agreements involving listed
agents and toxins to or with a registered person, and
to which information specified in paragraph (1) is trans-
ferred by any such registered person.
‘‘(3) OTHER EXEMPTIONS.—This subsection may not be con-
strued as altering the application of any exemptions to public
disclosure under section 552 of title 5, United States Code,
except as to subsection 552(b)(3) of such title, to any of the
information specified in paragraph (1).
‘‘(4) RULE OF CONSTRUCTION.—Except as specifically pro-
vided in paragraph (1), this subsection may not be construed
as altering the authority of any Federal agency to withhold
under section 552 of title 5, United States Code, or the obliga-
tion of any Federal agency to disclose under section 552 of
title 5, United States Code, any information, including informa-
tion relating to—
‘‘(A) listed agents and toxins, or individuals seeking
access to such agents and toxins;
‘‘(B) registered persons, or persons seeking to register
their possession, use, or transfer of such agents and toxins;
‘‘(C) general safeguard and security policies and
requirements under regulations under subsections (b) and
(c); or
‘‘(D) summary or statistical information concerning reg-
istrations, registrants, denials or revocations of registra-
tions, listed agents and toxins, inspection evaluations and
reports, or individuals seeking access to such agents and
toxins.
H. R. 3448—52
‘‘(5) DISCLOSURES TO CONGRESS; OTHER DISCLOSURES.—This
subsection may not be construed as providing any authority—
‘‘(A) to withhold information from the Congress or any
committee or subcommittee thereof; or
‘‘(B) to withhold information from any person under
any other Federal law or treaty.
‘‘(i) CIVIL MONEY PENALTY.—
‘‘(1) IN GENERAL.—In addition to any other penalties that
may apply under law, any person who violates any provision
of regulations under subsection (b) or (c) shall be subject to
the United States for a civil money penalty in an amount
not exceeding $250,000 in the case of an individual and
$500,000 in the case of any other person.
‘‘(2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions
of section 1128A of the Social Security Act (other than sub-
sections (a), (b), (h), and (i), the first sentence of subsection
(c), and paragraphs (1) and (2) of subsection (f)) shall apply
to a civil money penalty under paragraph (1) in the same
manner as such provisions apply to a penalty or proceeding
under section 1128A(a) of such Act. The Secretary may delegate
authority under this subsection in the same manner as provided
in section 1128A(j)(2) of the Social Security Act, and such
authority shall include all powers as contained in section 6
of the Inspector General Act of 1978 (5 U.S.C. App.).
‘‘(j) NOTIFICATION IN EVENT OF RELEASE.—Regulations under
subsections (b) and (c) shall require the prompt notification of
the Secretary by a registered person whenever a release, meeting
criteria established by the Secretary, of a listed agent or toxin
has occurred outside of the biocontainment area of a facility of
the registered person. Upon receipt of such notification and a finding
by the Secretary that the release poses a threat to public health
or safety, the Secretary shall take appropriate action to notify
relevant State and local public health authorities, other relevant
Federal authorities, and, if necessary, other appropriate persons
(including the public). If the released listed agent or toxin is an
overlap agent or toxin (as defined in subsection (l)), the Secretary
shall promptly notify the Secretary of Agriculture upon notification
by the registered person.
‘‘(k) REPORTS.—The Secretary shall report to the Congress
annually on the number and nature of notifications received under
subsection (e)(8) (relating to theft or loss) and subsection (j) (relating
to releases).
‘‘(l) DEFINITIONS.—For purposes of this section:
‘‘(1) The terms ‘biological agent’ and ‘toxin’ have the
meanings given such terms in section 178 of title 18, United
States Code.
‘‘(2) The term ‘listed agents and toxins’ means biological
agents and toxins listed pursuant to subsection (a)(1).
‘‘(3) The term ‘listed agents or toxins’ means biological
agents or toxins listed pursuant to subsection (a)(1).
‘‘(4) The term ‘overlap agents and toxins’ means biological
agents and toxins that—
‘‘(A) are listed pursuant to subsection (a)(1); and
‘‘(B) are listed pursuant to section 212(a)(1) of the
Agricultural Bioterrorism Protection Act of 2002.
‘‘(5) The term ‘overlap agent or toxin’ means a biological
agent or toxin that—
H. R. 3448—53
‘‘(A) is listed pursuant to subsection (a)(1); and
‘‘(B) is listed pursuant to section 212(a)(1) of the Agri-
cultural Bioterrorism Protection Act of 2002.
‘‘(6) The term ‘person’ includes Federal, State, and local
governmental entities.
‘‘(7) The term ‘registered person’ means a person registered
under regulations under subsection (b) or (c).
‘‘(8) The term ‘restricted person’ has the meaning given
such term in section 175b of title 18, United States Code.
‘‘(m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2002
through 2007.’’.
(b) REPORT TO CONGRESS.—Not later than one year after the
date of the enactment of this Act, the Secretary of Health and
Human Services, after consultation with other appropriate Federal
agencies, shall submit to the Congress a report that—
(1) describes the extent to which there has been compliance
by governmental and private entities with applicable regula-
tions under section 351A of the Public Health Service Act
(as added by subsection (a) of this section), including the extent
of compliance before the date of the enactment of this Act,
and including the extent of compliance with regulations promul-
gated after such date of enactment;
(2) describes the actions to date and future plans of the
Secretary for updating the list of biological agents and toxins
under such section 351A;
(3) describes the actions to date and future plans of the
Secretary for determining compliance with regulations under
such section 351A and for taking appropriate enforcement
actions;
(4) evaluates the impact of such section 351A on research
on biological agents and toxins listed pursuant to such section;
and
(5) provides any recommendations of the Secretary for
administrative or legislative initiatives regarding such section
351A.
SEC. 202. IMPLEMENTATION BY DEPARTMENT OF HEALTH AND HUMAN
SERVICES.
(a) DATE CERTAIN FOR NOTICE OF POSSESSION.—Not later than
90 days after the date of the enactment of this Act, all persons
(unless exempt under subsection (g) of section 351A of the Public
Health Service Act, as added by section 201 of this Act) in possession
of biological agents or toxins listed under such section 351A of
the Public Health Service Act shall notify the Secretary of Health
and Human Services of such possession. Not later than 30 days
after such date of enactment, the Secretary shall provide written
guidance on how such notice is to be provided to the Secretary.
(b) DATE
CERTAIN
FOR
PROMULGATION; EFFECTIVE
DATE
REGARDING CRIMINAL AND CIVIL PENALTIES.—Not later than 180
days after the date of the enactment of this Act, the Secretary
of Health and Human Services shall promulgate an interim final
rule for carrying out section 351A of the Public Health Service
Act, subject to subsection (c). Such interim final rule shall take
effect 60 days after the date on which such rule is promulgated,
including for purposes of—
H. R. 3448—54
(1) section 175b(c) of title 18, United States Code (relating
to criminal penalties), as added by section 231(a)(5) of this
Act; and
(2) section 351A(i) of the Public Health Service Act (relating
to civil penalties).
(c) TRANSITIONAL PROVISION REGARDING CURRENT RESEARCH
AND EDUCATION.—The interim final rule under subsection (b) shall
include time frames for the applicability of the rule that minimize
disruption of research or educational projects that involve biological
agents and toxins listed pursuant to section 351A(a)(1) of the Public
Health Service Act and that were underway as of the effective
date of such rule.
SEC. 203. EFFECTIVE DATES.
(a) IN GENERAL.—Regulations promulgated by the Secretary
of Health and Human Services under section 511 of the
Antiterrorism and Effective Death Penalty Act of 1996 are deemed
to have been promulgated under section 351A of the Public Health
Service Act, as added by section 201 of this Act. Such regulations,
including the list under subsection (d)(1) of such section 511, that
were in effect on the day before the date of the enactment of
this Act remain in effect until modified by the Secretary in accord-
ance with such section 351A and with section 202 of this Act.
(b) EFFECTIVE DATE REGARDING DISCLOSURE
OF INFORMA-
TION.—Subsection (h) of section 351A of the Public Health Service
Act, as added by section 201 of this Act, is deemed to have taken
effect on the effective date of the Antiterrorism and Effective Death
Penalty Act of 1996.
SEC. 204. CONFORMING AMENDMENT.
Subsections (d), (e), (f), and (g) of section 511 of the
Antiterrorism and Effective Death Penalty Act of 1996 (42 U.S.C.
262 note) are repealed.
Subtitle B—Department of Agriculture
SEC. 211. SHORT TITLE.
This subtitle may be cited as the ‘‘Agricultural Bioterrorism
Protection Act of 2002’’.
SEC. 212. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS AND
TOXINS.—
(1) LIST OF BIOLOGICAL AGENTS AND TOXINS.—
(A) IN GENERAL.—The Secretary of Agriculture shall
by regulation establish and maintain a list of each
biological agent and each toxin that the Secretary deter-
mines has the potential to pose a severe threat to animal
or plant health, or to animal or plant products.
(B) CRITERIA.—In determining whether to include an
agent or toxin on the list under subparagraph (A), the
Secretary shall—
(i) consider—
(I) the effect of exposure to the agent or toxin
on animal or plant health, and on the production
and marketability of animal or plant products;
H. R. 3448—55
(II) the pathogenicity of the agent or the tox-
icity of the toxin and the methods by which the
agent or toxin is transferred to animals or plants;
(III) the availability and effectiveness of
pharmacotherapies and prophylaxis to treat and
prevent any illness caused by the agent or toxin;
and
(IV) any other criteria that the Secretary con-
siders appropriate to protect animal or plant
health, or animal or plant products; and
(ii) consult with appropriate Federal departments
and agencies and with scientific experts representing
appropriate professional groups.
(2) BIENNIAL
REVIEW.—The Secretary shall review and
republish the list under paragraph (1) biennially, or more often
as needed, and shall by regulation revise the list as necessary
in accordance with such paragraph.
(b) REGULATION
OF
TRANSFERS
OF
LISTED
AGENTS
AND
TOXINS.—The Secretary shall by regulation provide for—
(1) the establishment and enforcement of safety procedures
for the transfer of listed agents and toxins, including measures
to ensure—
(A) proper training and appropriate skills to handle
such agents and toxins; and
(B) proper laboratory facilities to contain and dispose
of such agents and toxins;
(2) the establishment and enforcement of safeguard and
security measures to prevent access to such agents and toxins
for use in domestic or international terrorism or for any other
criminal purpose;
(3) the establishment of procedures to protect animal and
plant health, and animal and plant products, in the event
of a transfer or potential transfer of such an agent or toxin
in violation of the safety procedures established under para-
graph (1) or the safeguard and security measures established
under paragraph (2); and
(4) appropriate availability of biological agents and toxins
for research, education, and other legitimate purposes.
(c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.—
The Secretary shall by regulation provide for the establishment
and enforcement of standards and procedures governing the posses-
sion and use of listed agents and toxins, including the provisions
described in paragraphs (1) through (4) of subsection (b), in order
to protect animal and plant health, and animal and plant products.
(d) REGISTRATION; IDENTIFICATION; DATABASE.—
(1) REGISTRATION.—Regulations under subsections (b) and
(c) shall require registration with the Secretary of the posses-
sion, use, and transfer of listed agents and toxins, and shall
include provisions to ensure that persons seeking to register
under such regulations have a lawful purpose to possess, use,
or transfer such agents and toxins, including provisions in
accordance with subsection (e)(6).
(2) IDENTIFICATION; DATABASE.—Regulations under sub-
sections (b) and (c) shall require that registration include (if
available to the person registering) information regarding the
characterization of listed agents and toxins to facilitate their
H. R. 3448—56
identification, including their source. The Secretary shall main-
tain a national database that includes the names and locations
of registered persons, the listed agents and toxins such persons
are possessing, using, or transferring, and information
regarding the characterization of such agents and toxins.
(e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED
PERSONS.—
(1) IN GENERAL.—Regulations under subsections (b) and
(c) shall include appropriate safeguard and security require-
ments for persons possessing, using, or transferring a listed
agent or toxin commensurate with the risk such agent or toxin
poses to animal and plant health, and animal and plant prod-
ucts (including the risk of use in domestic or international
terrorism). The Secretary shall establish such requirements
in consultation with the Attorney General, and shall ensure
compliance with such requirements as part of the registration
system under such regulations.
(2) LIMITING
ACCESS
TO
LISTED
AGENTS
AND
TOXINS.—
Requirements under paragraph (1) shall include provisions to
ensure that registered persons—
(A) provide access to listed agents and toxins to only
those individuals whom the registered person involved
determines have a legitimate need to handle or use such
agents and toxins;
(B) submit the names and other identifying information
for such individuals to the Secretary and the Attorney
General, promptly after first determining that the individ-
uals need access under subparagraph (A), and periodically
thereafter while the individuals have such access, not less
frequently than once every five years; and
(C)(i) in the case of listed agents and toxins that are
not overlap agents and toxins (as defined in subsection
(g)(1)(A)(ii)), limit or deny access to such agents and toxins
by individuals whom the Attorney General has identified
as within any category under paragraph (3)(B), if limiting
or denying such access by the individuals involved is deter-
mined appropriate by the Secretary, in consultation with
the Attorney General; and
(ii) in the case of listed agents and toxins that are
overlap agents—
(I) deny access to such agents and toxins by
individuals whom the Attorney General has identi-
fied as within any category referred to in para-
graph (3)(B)(i); and
(II) limit or deny access to such agents and
toxins by individuals whom the Attorney General
has identified as within any category under para-
graph (3)(B)(ii), if limiting or denying such access
by the individuals involved is determined appro-
priate by the Secretary, in consultation with the
Attorney General.
(3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY
GENERAL.—
(A) IN GENERAL.—Upon the receipt of names and other
identifying information under paragraph (2)(B), the
Attorney General shall, for the sole purpose of identifying
whether the individuals involved are within any of the
H. R. 3448—57
categories specified in subparagraph (B), promptly use
criminal, immigration, national security, and other elec-
tronic databases that are available to the Federal Govern-
ment and are appropriate for such purpose.
(B) CERTAIN INDIVIDUALS.—For purposes of subpara-
graph (A), the categories specified in this subparagraph
regarding an individual are that—
(i) the individual is within any of the categories
described in section 175b(d)(1) of title 18, United States
Code (relating to restricted persons); or
(ii) the individual is reasonably suspected by any
Federal law enforcement or intelligence agency of—
(I) committing a crime set forth in section
2332b(g)(5) of title 18, United States Code;
(II) knowing involvement with an organization
that engages in domestic or international terrorism
(as defined in section 2331 of such title 18) or
with any other organization that engages in inten-
tional crimes of violence; or
(III) being an agent of a foreign power (as
defined in section 1801 of title 50, United States
Code).
(C) NOTIFICATION BY ATTORNEY GENERAL REGARDING
SUBMITTED NAMES.—After the receipt of a name and other
identifying information under paragraph (2)(B), the
Attorney General shall promptly notify the Secretary
whether the individual is within any of the categories
specified in subparagraph (B).
(4) NOTIFICATIONS
BY
SECRETARY.—The Secretary, after
receiving notice under paragraph (3) regarding an individual,
shall promptly notify the registered person involved of whether
the individual is granted or denied access under paragraph
(2). If the individual is denied such access, the Secretary shall
promptly notify the individual of the denial.
(5) EXPEDITED REVIEW.—Regulations under subsections (b)
and (c) shall provide for a procedure through which, upon
request to the Secretary by a registered person who submits
names and other identifying information under paragraph
(2)(B) and who demonstrates good cause, the Secretary may,
as determined appropriate by the Secretary—
(A) request the Attorney General to expedite the
process of identification under paragraph (3)(A) and
notification of the Secretary under paragraph (3)(C); and
(B) expedite the notification of the registered person
by the Secretary under paragraph (4).
(6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.—
(A) INDIVIDUALS.—Regulations under subsections (b)
and (c) shall provide that an individual who seeks to reg-
ister under either of such subsections is subject to the
same processes described in paragraphs (2) through (4)
as apply to names and other identifying information sub-
mitted to the Attorney General under paragraph (2)(B).
Paragraph (5) does not apply for purposes of this subpara-
graph.
(B) OTHER PERSONS.—Regulations under subsections
(b) and (c) shall provide that, in determining whether to
deny or revoke registration by a person other than an