107th Congress
2d Session HOUSE OF REPRESENTATIVES Report 107-481
_______________________________________________________________________
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT
OF 2002
__________
CONFERENCE REPORT
to accompany
H.R. 3448
May 21, 2002.--Ordered to be printed
107th Congress
2d Session HOUSE OF REPRESENTATIVES Report 107-481
======================================================================
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT
OF 2002
_______
May 21, 2002.--Ordered to be printed
_______
Mr. Tauzin, from the Committee of conference, submitted the following
CONFERENCE REPORT
[To accompany H.R. 3448]
[...]
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.
(a) Biological Agents Provisions of the Antiterrorism and
Effective Death Penalty Act of 1996; Codification in the Public
Health Service Act, With Amendments.--Subpart 1 of part F of
title III of the Public Health Service Act (42 U.S.C. 262 et
seq.) is amended by inserting after section 351 the following:
"SEC. 351A. ENHANCED CONTROL OF DANGEROUS 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 shall by
regulation establish and maintain a list of
each biological agent and each toxin that has
the potential to pose a severe threat to public
health and safety.
"(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 on human
health of exposure to the agent
or toxin;
"(II) the degree of
contagiousness of the agent or
toxin and the methods by which
the agent or toxin is
transferred to humans;
"(III) the availability
and effectiveness of
pharmacotherapies and
immunizations to treat and
prevent any illness resulting
from infection by the agent or
toxin; and
"(IV) any other criteria,
including the needs of children
and other vulnerable
populations, that the Secretary
considers appropriate; and
"(ii) consult with appropriate
Federal departments and agencies and
with scientific experts representing
appropriate professional groups,
including groups with pediatric
expertise.
"(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
the public safety in the event of a transfer or
potential transfer of such an agent or toxin in
violation of the safety procedures established under
paragraph (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
possession and use of listed agents and toxins, including the
provisions described in paragraphs (1) through (4) of
subsection (b), in order to protect the public health and
safety.
"(d) Registration; Identification; Database.--
"(1) Registration.--Regulations under subsections
(b) and (c) shall require registration with the
Secretary of the possession, 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
subsections (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 identification,
including their source. The Secretary shall maintain 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 requirements for persons possessing, using, or
transferring a listed agent or toxin commensurate with
the risk such agent or toxin poses to public health and
safety (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
individuals need access under subparagraph (A),
and periodically thereafter while the
individuals have such access, not less
frequently than once every five years;
"(C) deny access to such agents and toxins
by individuals whom the Attorney General has
identified as restricted persons; and
"(D) 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)(ii), if limiting or
denying such access by the individuals involved
is determined appropriate 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
categories specified in subparagraph (B),
promptly use criminal, immigration, national
security, and other electronic databases that
are available to the Federal Government and are
appropriate for such purpose.
"(B) Certain individuals.--For purposes of
subparagraph (A), the categories specified in
this subparagraph regarding an individual are
that--
"(i) the individual is a
restricted person; 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
intentional 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 register 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 submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph.
"(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
individual, the Secretary shall submit the name
of such person to the Attorney General, who
shall use criminal, immigration, national
security, and other electronic databases
available to the Federal Government, as
appropriate for the purpose of promptly
notifying the Secretary whether the person, or,
where relevant, the individual who owns or
controls such person, is a restricted person or
is reasonably suspected by any Federal law
enforcement or intelligence agency of being
within any category specified in paragraph
(3)(B)(ii) (as applied to persons, including
individuals). Such regulations shall provide
that a person who seeks to register under
either of such subsections is subject to the
same processes described in paragraphs (2) and
(4) as apply to names and other identifying
information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph. The
Secretary may exempt Federal, State, or local
governmental agencies from the requirements of
this subparagraph.
"(7) Review.--
"(A) Administrative review.--
"(i) In general.--Regulations
under subsections (b) and (c) shall
provide for an opportunity for a review
by the Secretary--
"(I) when requested by the
individual involved, of a
determination under paragraph
(2) to deny the individual
access to listed agents and
toxins; and
"(II) when requested by
the person involved, of a
determination under paragraph
(6) to deny or revoke
registration for such person.
"(ii) Ex parte review.--During a
review under clause (i), the Secretary
may consider information relevant to
the review ex parte to the extent that
disclosure of the information could
compromise national security or an
investigation by any law enforcement agency.
"(iii) Final agency action.--The
decision of the Secretary in a review
under clause (i) constitutes final
agency action for purposes of section
702 of title 5, United States Code.
"(B) Certain procedures.--
"(i) Submission of ex parte
materials in judicial proceedings.--
When reviewing a decision of the
Secretary under subparagraph (A), and
upon request made ex parte and in
writing by the United States, a court,
upon a sufficient showing, may review
and consider ex parte documents
containing information the disclosure
of which could compromise national
security or an investigation by any law
enforcement agency. If the court
determines that portions of the
documents considered ex parte should be
disclosed to the person involved to
allow a response, the court shall
authorize the United States to delete
from such documents specified items of
information the disclosure of which
could compromise national security or
an investigation by any law enforcement
agency, or to substitute a summary of
the information to which the person may
respond. Any order by the court
authorizing the disclosure of
information that the United States
believes could compromise national
security or an investigation by any law
enforcement agency shall be subject to
the processes set forth in
subparagraphs (A) and (B)(i) of section
2339B(f)(5) of title 18, United States
Code (relating to interlocutory appeal
and expedited consideration).
"(ii) Disclosure of information.--
In a review under subparagraph (A), and
in any judical proceeding conducted
pursuant to such review, neither the
Secretary nor the Attorney General may
be required to disclose to the public
any information that under subsection
(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 prohibitions 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 presented for
diagnosis, verification, or proficiency testing,
provided that--
"(A) the identification of such agents or
toxins is reported to the Secretary, and when
required under Federal, 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
subparagraph (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 following:
"(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
(b) or (c) to such product is not
necessary to protect public health and
safety.
"(ii) Certain processes.--
Regulations under subsections (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 determined 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
Federal 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 submitted 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 subsection (d), or any other
compilation of the registration or transfer
information submitted under subsections (b) 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 measures 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 subsections.
"(E) Any portion of an evaluation or
report of an inspection of a specific
registered person conducted under subsection
(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
transferred by any such registered person.
"(3) Other exemptions.--This subsection may not be
construed 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
provided 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 obligation of any Federal agency to
disclose under section 552 of title 5, United States
Code, any information, including information 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 registrations, registrants, denials
or revocations of registrations, listed agents
and toxins, inspection evaluations and reports,
or individuals seeking access to such agents
and toxins.
"(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 subsections (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--
"(A) is listed pursuant to subsection
(a)(1); and
"(B) is listed pursuant to section
212(a)(1) of the Agricultural 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 regulations 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 promulgated 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--
(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 accordance with such section 351A
and with section 202 of this Act.
(b) Effective Date Regarding Disclosure of Information.--
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 determines 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;
(II) the pathogenicity of
the agent or the toxicity 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 considers
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 paragraph (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
possession 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 possession, 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
subsections (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 identification,
including their source. The Secretary shall maintain 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 requirements 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 products (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 individuals
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
determined 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 identified as
within any category referred to
in paragraph (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
paragraph (3)(B)(ii), if
limiting or denying such access
by the individuals involved is
determined appropriate 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
categories specified in subparagraph (B),
promptly use criminal, immigration, national
security, and other electronic databases that
are available to the Federal Government and are
appropriate for such purpose.
(B) Certain individuals.--For purposes of
subparagraph (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
intentional 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 register 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 submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph.
(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
individual, the Secretary shall submit the name
of such person to the Attorney General, who
shall use criminal, immigration, national
security, and other electronic databases
available to the Federal Government, as
appropriate for the purpose of promptly
notifying the Secretary whether the person, or,
where relevant, the individual who owns or
controls such person, is within any of the
categories described in section 175b(d)(1) of
title 18, United States Code (relating to
restricted persons), or is reasonably suspected
by any Federal law enforcement or intelligence
agency of being within any category specified
in paragraph (3)(B)(ii) (as applied to persons,
including individuals). Such regulations shall
provide that a person who seeks to register
under either of such subsections is subject to
the same processes described in paragraphs (2)
and (4) as apply to names and other identifying
information submitted to the Attorney General
under paragraph (2)(B). Paragraph (5) does not
apply for purposes of this subparagraph. The
Secretary may exempt Federal, State, or local
governmental agencies from the requirements of
this subparagraph.
(7) Review.--
(A) Administrative review.--
(i) In general.--Regulations under
subsections (b) and (c) shall provide
for an opportunity for a review by the
Secretary--
(I) when requested by the
individual involved, of a
determination under paragraph
(2) to deny the individual
access to listed agents and
toxins; and
(II) when requested by the
person involved, of a
determination under paragraph
(6) to deny or revoke
registration for such person.
(ii) Ex parte review.--During a
review under clause (i), the Secretary
may consider information relevant to
the review ex parte to the extent that
disclosure of the information could
compromise national security or an
investigation by any law enforcement
agency.
(iii) Final agency action.--The
decision of the Secretary in a review
under clause (i) constitutes final
agency action for purposes of section
702 of title 5, United States Code.
(B) Certain procedures.--
(i) Submission of ex parte
materials in judicial proceedings.--
When reviewing a decision of the
Secretary under subparagraph (A), and
upon request made ex parte and in
writing by the United States, a court,
upon a sufficient showing, may review
and consider ex parte documents
containing information the disclosure
of which could compromise national
security or an investigation by any law
enforcement agency. If the court
determines that portions of the
documents considered ex parte should be
disclosed to the person involved to
allow a response, the court shall
authorize the United States to delete
from such documents specified items of
information the disclosure of which
could compromise national security or
an investigation by any law enforcement
agency, or to substitute a summary of
the information to which the person may
respond. Any order by the court
authorizing the disclosure of
information that the United States
believes could compromise national
security or an investigation by any law
enforcement agency shall be subject to
the processes set forth in
subparagraphs (A) and (B)(i) of section
2339B(f)(5) of title 18, United States
Code (relating to interlocutory appeal
and expedited consideration).
(ii) Disclosure of information.--In
a review under subparagraph (A), and in
any judical proceeding conducted
pursuant to such review, neither the
Secretary nor the Attorney General may
be required to disclose to the public
any information that under subsection
(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
prohibitions on restricted persons and other provisions of
subsection (e).
(g) Exemptions.--
(1) Overlap agents and toxins.--
(A) In general.--
(i) Limitation.--In the case of
overlap agents and toxins, exemptions
from the applicability of provisions of
regulations under subsection (b) or (c)
may be granted only to the extent
provided in this paragraph.
(ii) Definitions.--For purposes of
this section:
(I) The term "overlap
agents and toxins" means
biological agents and toxins
that--
(aa) are listed
pursuant to subsection
(a)(1); and
(bb) are listed
pursuant to section
315A(a)(1) of the
Public Health Service
Act.
(II) The term "overlap
agent or toxin" means a
biological agent or toxin
that--
(aa) is listed
pursuant to subsection
(a)(1); and
(bb) is listed
pursuant to section
315A(a)(1) of the
Public Health Service
Act.
(B) Clinical or diagnostic laboratories.--
Regulations under subsections (b) and (c) shall
exempt clinical or diagnostic laboratories and
other persons who possess, use, or transfer
overlap agents or toxins that are contained in
specimens presented for diagnosis,
verification, or proficiency testing, provided
that--
(i) the identification of such
agents or toxins is reported to the
Secretary, and when required under
Federal, State, or local law, to other
appropriate authorities; and
(ii) such agents or toxins are
transferred or destroyed in a manner
set forth by the Secretary by
regulation.
(C) Products.--
(i) In general.--Regulations under
subsections (b) and (c) shall exempt
products that are, bear, or contain
overlap agents or toxins and are
cleared, approved, licensed, or
registered under any of the Acts
specified in clause (ii), unless the
Secretary by order determines that
applying additional regulation under
subsection (b) or (c) to a specific
product is necessary to protect animal
or plant health, or animal or plant
products.
(ii) Relevant laws.--For purposes
of clause (i), the Acts specified in
this clause are the following:
(I) The Federal Food, Drug,
and Cosmetic Act.
(II) Section 351 of the
Public Health Service 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.
(iii) Investigational use.--
(I) In general.--The
Secretary may exempt an
investigational product that
is, bears, or contains an
overlap 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 (b) or (c) to such
product is not necessary to
protect animal and plant
health, and animal and plant
products.
(II) Certain processes.--
Regulations under subsections
(b) and (c) shall set forth the
procedures for applying for an
exemption under subclause (I).
In the case of investigational
products authorized under any
of the Acts specified in clause
(ii), 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:
(aa) The person has
submitted to the
Secretary an
application for the
exemption meeting the
requirements
established by the
Secretary.
(bb) The person has
notified the Secretary
that the investigation
has been authorized
under such an Act.
(D) Agricultural emergencies.-- The
Secretary may temporarily exempt a person from
the applicability of the requirements of this
section with respect to an overlap agent or
toxin, 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
agricultural emergency that involves such an
agent or toxin. With respect to the emergency
involved, the exemption under this subparagraph
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.
(E) Public health emergencies.--Upon
request of the Secretary of Health and Human
Services, after the granting by such Secretary
of an exemption under 351A(g)(3) of the Public
Health Service Act pursuant to a finding that
there is a public health emergency, the
Secretary of Agriculture may temporarily exempt
a person from the applicability of the
requirements of this section with respect to an
overlap agent or toxin, in whole or in part, to
provide for the timely participation of the
person in a response to the public health
emergency. With respect to the emergency
involved, such exemption for a person may not
exceed 30 days, except that upon request of the
Secretary of Health and Human Services, the
Secretary of Agriculture may, after review of
whether such exemption remains necessary,
provide one extension of an additional 30 days.
(2) General authority for exemptions not involving
overlap agents or toxins.--In the case of listed agents
or toxins that are not overlap agents or toxins, the
Secretary may grant exemptions from the applicability
of provisions of regulations under subsection (b) or
(c) if the Secretary determines that such exemptions
are consistent with protecting animal and plant health,
and animal and plant products.
(h) Disclosure of Information.--
(1) Nondisclosure of certain information.--No
Federal 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 submitted under subsections (b)
and (c), or permits issued prior to the date of
the enactment of this Act, 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
person or discloses the identity or location of
a specific person.
(B) The national database developed
pursuant to subsection (d), or any other
compilation of the registration or transfer
information submitted under subsections (b) 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 measures 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 subsections.
(E) Any portion of an evaluation or report
of an inspection of a specific registered
person conducted under subsection (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 animal or plant
health, or animal or plant products.
(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
transferred by any such registered person.
(3) Other exemptions.--This subsection may not be
construed 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
provided 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 obligation of any Federal agency to
disclose under section 552 of title 5, United States
Code, any information, including information 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 registrations, registrants, denials
or revocations of registrations, listed agents
and toxins, inspection evaluations and reports,
or individuals seeking access to such agents
and toxins.
(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 sections 423 and 425(2) of the Plant
Protection Act (7 U.S.C. 7733 and 7735(2) shall apply
to a civil money penalty or activity under paragraph
(1) in the same manner as such provisions apply to a
penalty or activity under the Plant Protection Act.
(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 animal or plant health, or animal or plant
products, the Secretary shall take appropriate action to notify
relevant Federal, State, and local authorities, and, if
necessary, other appropriate persons (including the public). If
the released listed agent or toxin is an overlap agent or
toxin, the Secretary shall promptly notify the Secretary of
Health and Human Services 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 terms "overlap agents and toxins" and
"overlap agent or toxin" have the meaning given such
terms in subsection (g)(1)(A)(ii).
(5) The term "person" includes Federal, State,
and local governmental entities.
(6) The term "registered person" means a person
registered under regulations under subsection (b) or
(c).
(7) The term "`Secretary" means the Secretary of
Agriculture.
(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, in addition to other funds that
may be available.
SEC. 213. IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE.
(a) Date Certain for Promulgation of List.--Not later than
60 days after the date of the enactment of this Act, the
Secretary of Agriculture (referred to in this section as the
"Secretary") shall promulgate an interim final rule that
establishes the initial list under section 212(a)(1). In
promulgating such rule, the Secretary shall provide written
guidance on the manner in which the notice required in
subsection (b) is to be provided to the Secretary.
(b) Date Certain for Notice of Possession.--Not later than
60 days after the date on which the Secretary promulgates the
interim final rule under subsection (a), all persons (unless
exempt under section 212(g)) in possession of biological agents
or toxins included on the list referred to in subsection (a)
shall notify the Secretary of such possession.
(c) 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 shall
promulgate an interim final rule for carrying out section 212,
other than for the list referred to in subsection (a) of this
section (but such rule may incorporate by reference provisions
promulgated pursuant to subsection (a)). Such interim final
rule shall take effect 60 days after the date on which such
rule is promulgated, including for purposes of--
(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 212(i) of this Act (relating to civil
penalties).
(d) Transitional Provision Regarding Current Research and
Education.--The interim final rule under subsection (c) 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
212(a)(1) and that were underway as of the effective date of
such rule.
[...]
JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF CONFERENCE
[...]
TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
Subtitle A--Department of Health and Human Services
Section 201. Regulation of Certain Biological Agents and Toxins
House provision: The House bill requires all persons who
possess, use or transfer "select agents"--the 36 biological
agents or toxins currently determined by the Secretary of the
Department of Health and Human Services (HHS) to pose "a
severe threat to public health and safety"--to register with
the Secretary and be subject to reasonable safety and security
requirements and inspections. Current law requires registration
only of those entities transferring such agents. The House bill
also directs that the Secretary maintain a national database of
all such agents, with sufficient information to facilitate
their identification and traceability. The Secretary, in
consultation with the Attorney General, must establish specific
security requirements for registered facilities and a personnel
screening protocol to ensure that access to such agents is not
permitted by individuals who are "restricted persons" under
the USA PATRIOT Act (18 U.S.C. 175b), are named in a warrant
for violent criminal or terrorist activity, are under
investigation for involvement in domestic or international
terrorist or criminal organizations, or suspected of spying for
the military or intelligence operations of a foreign nation.
The Secretary is granted authority to assist public and
nonprofit private entities in meeting such security
requirements. The House bill also imposes civil penalties for
those who violate the regulations, up to $500,000.
The House bill grants the Secretary discretion to make
exemptions to the registration requirements only where those
exemptions are consistent with protecting the public health and
safety--for example, with respect to inactivated or attenuated
strains of select agents used in vaccines or other products for
legitimate medical research or use--or when the agent is
presented for diagnosis, verification or proficiency testing
purposes at a clinical laboratory and is promptly destroyed or
transferred to a registered facility after such identification.
The House bill also exempts from mandatory disclosure under the
Freedom of Information Act (FOIA) site-specific or identifying
information submitted under these regulations concerning
registered persons, select agents, and security mechanisms.
Senate amendment: The Senate amendment is substantially
similar to the House bill but differs in a few respects. First,
in developing the list of select agents, the Secretary is
directed to consider the needs of children and other vulnerable
populations. Second, individuals who seek access to select
agents are screened only to identify if they are "restricted
persons" under the USA PATRIOT Act, or are named in a warrant
for participation in a domestic or international act of
terrorism. Third, the Secretary is permitted to exempt certain
attenuated or inactive biological agents or toxins and certain
approved medical products from the list of select agents.
Conference substitute: The Conference substitute adopts
provisions of both bills, with significant modifications. The
primary goals of this subtitle are to ensure the prompt
reporting to the Federal government of possession of select
agents (including by those who were in possession prior to
April 15, 1997, the effective date for reporting transfers of
select agents), to increase the security over such agents
(including access controls and screening of personnel), and to
establish a comprehensive and detailed national database of the
location and characterization of such agents and the identities
of those in possession of them. To effectuate these goals, the
substitute requires that, at a minimum, all possession of
select agents (unless exempt under the provisions of this
subtitle) must be registered with the Secretary. The Managers
expect that most "persons" who register under this subtitle
will be public and private entities, rather than individuals.
But these provisions also will cover individuals possessing,
using or transferring select agents who have not been granted
authority to do so by registered persons. If an individual has
not been granted such authority, then that individual would be
a person required to register under this subtitle. If an
individual has been granted such authority without proper
authorization from the Secretary, as required by this subtitle,
then the registered person is subject to any penalties provided
for violation of such regulations. The Managers emphasize that
the primary responsibility for registration and the screening
of employees working with select agents is with the entity or
employer, not the individual employee. The Secretary also is
required to promulgate regulations establishing safety
requirements for the possession, use, and transfer of select
agents. These regulations must include procedures to protect
the public safety in the event the safety requirements for
possession, use or transfer are violated.
The Managers recognize that some select agents may pose a
greater threat to the public health and safety than others.
Accordingly, the Conference substitute amends the security
requirements of both bills by adding the phrase "commensurate
with the risk such agent or toxin poses to public health and
safety (including the risk of use in domestic or international
terrorism)." The Secretary will have flexibility to impose
different levels of security requirements on different select
agents based on his or her evaluation of the level of threat to
the public, as is currently done with respect to laboratory
biosafety levels. Because an agent must pose a severe threat to
human health to be placed on the select agent list, the
Secretary may not decide that security requirements or
registration of possession are unnecessary for a particular
select agent.
The substitute also modifies the existing statutory
requirements for the transfer regulations by adding "and
security measures" after "safeguards" in the term
"safeguards to prevent access . . . for use in domestic or
international terrorism or for any other criminal purposes" to
clarify that such regulations include the imposition of
security requirements. The substitute also requires that
registered persons promptly notify the Secretary whenever a
select agent is lost, stolen, or released outside of a
biocontainment area of a facility. Current HHS regulations do
not mandate such notifications.
The Conference substitute adds new provisions regarding
the screening of entities and individuals seeking to register
their possession, use or transfer of select agents. While both
the House and Senate bills mandate screening of individuals
seeking access to agents through a registered person, neither
bill required screening of the registered persons themselves.
The substitute provides for such screening in a similar manner
to that performed for individuals working at the facilities of
registered persons. Further with respect to screening, the
substitute drops the provision in both bills relating to
outstanding warrants, as duplicative of the fugitive provision
in the restricted person categories of the USA PATRIOT Act, and
adds a screening category that was in neither bill--those
reasonably suspected of committing Federal crimes of terrorism.
The substitute includes but makes revisions to the two
additional screening categories contained in the House bill to
ensure an objective basis for governmental suspicion of
involvement with terrorist or criminal organizations, or with
foreign powers. In the case of restricted persons, the
substitute mandates that access to select agents be denied,
because of the criminal prohibition on possession by such
persons. In the case ofpersons falling within the other three
specified categories, the substitute grants the Secretary and Attorney
General discretion in determining how to proceed, given the law
enforcement sensitivity of such situations. By making this distinction
between the handling of restricted persons and other screening
categories, the Managers do not intend that potential terrorists or
foreign agents should be subject to a less strict screening standard
than restricted persons. The substitute also clarifies that the
screening performed by the Attorney General is for the sole purpose of
identifying--through the use of official, electronic databases
available to the Federal government--whether an individual or entity
falls within any of the specified categories, and for notifying the HHS
Secretary of such identification. It is the Managers' intent that the
term "electronic databases" is not meant to preclude the use of other
databases or files by the Attorney General to clarify or confirm
information obtained during the electronic database search.
To address concerns within the academic and research
communities about the timeliness and accuracy of the background
screening process, the Conference substitute amends both bills
by requiring "prompt" action by the Attorney General and the
Secretary with respect to screening of and notification to
affected individuals, and by providing for an expedited review
process where good cause has been demonstrated by the
registered person. The substitute also provides for a review of
denials by the Secretary based on the screening process, and
subsequent judicial review--with provisions to ensure that
classified or sensitive law enforcement information is not
compromised during such reviews. Specifically, the substitute
allows for ex parte review by the Secretary in administrative
proceedings, and the court during judicial review, whenever a
denial is challenged. In providing the right for ex parte
review, the Managers intend to protect classified and law
enforcement sensitive information, including through the use of
in camera proceedings. Moreover, the Managers intend that a
reviewing court should not order the disclosure of any
information that the United States believes may compromise
national security or an ongoing law enforcement investigation
without affording the United States an opportunity for further
review in accordance with this subtitle. It is the Managers'
overall expectation that the screening process be conducted in
a timely and fair manner, and that the Secretary and the
Attorney General will work closely together to effectuate such
intent.
With respect to the national database of select agents
that the Secretary must develop pursuant to this section, the
Conference substitute slightly alters the language used in both
bills with respect to the database's purpose. The object of the
registration and database requirements is to provide
information about all persons possessing, using or transferring
select agents, and to collect sufficiently detailed
characterization information on the registered select agents so
that the database can differentiate between and within strains
of a given agent or toxin. Such information should be in a
format that public health and law enforcement officials can use
to identify the origin or source of an agent or toxin that is
used to cause harm to the public. Because of concerns over the
potential for misconstruction, the term "traceability"--which
could imply a chain of custody or tracking requirement--was
eliminated, and was replaced with the concept of "source."
Significant modifications were made to both bills with
respect to exemptions from the statutory and regulatory
requirements governing select agents. The Conference substitute
establishes several exemptions from the regulatory regime for
select agents, most of which are consistent with the
Secretary's current regulations and practices. First, the
Conference substitute adopts, with modifications, the Senate
amendment's language with respect to product exemptions. The
substitute directs the Secretary to exempt from such
regulations products that are, bear or contain a select agent
and are licensed or approved under several specified Federal
laws, unless the Secretary determines that additional
regulation is necessary for a specific product to ensure
protection of public health and safety. The Managers intend
that the Secretary will exempt by regulation categories of
products, consistent with current regulations, and will act to
regulate a specific product, or a particular application of a
specific product, only when existing regulation under other
Federal laws is inadequate. For example, HHS currently exempts
the FDA-approved medical product Botox, which is the select
agent botulinum toxin, when it is used by licensed physicians
in the treatment of patients. However, when it is used in
purely research settings or as part of early-stage clinical
trials, HHS has chosen not to exempt Botox from current
regulations. The Managers do not intend to alter this
flexibility.
Second, the Conference substitute adds a provision
granting the Secretary discretionary authority to exempt, on a
case-by-case basis, investigational products when they are
being used in investigational or clinical trials authorized
under other Federal laws, such as the Federal Food, Drug, and
Cosmetic Act. Given the time sensitivity of such trials, the
substitute also includes a provision mandating a prompt
determinationby the Secretary of such an exemption request--
within 14 days after the applicant has submitted a complete exemption
request and has notified the Secretary that the investigation may
proceed as authorized under Federal law.
Third, with respect to clinical or diagnostic
laboratories that may come into possession of select agents
when conducting specimen diagnosis, verification or proficiency
testing, the substitute adopts with minor changes the
comparable provisions in the House and Senate bills. The
Secretary shall exempt such laboratories from registration
requirements, but only if they report the identification of
select agents to the Secretary and either promptly transfer the
agent to a registered person or destroy the agent on site, in
accordance with regulations established by the Secretary. While
HHS currently exempts such laboratories, existing regulations
permit them to transfer, destroy, or store the agent on site
for reference purposes. The Conference substitute expressly
rejects that regulatory approach, as it is inconsistent with
the fundamental premise of this title--that all those who
maintain possession of a select agent must register and be
subject to appropriate security and safety requirements. The
Secretary may not exempt laboratories that possess select
agents for reference purposes, or any other clinical or
diagnostic laboratories that do not qualify for an exemption
under the terms of this title. In addition, the Conference
substitute creates two temporary exemption authorities to deal
with public health emergencies and agricultural emergencies,
whether domestic or foreign.
With respect to funding, the Conference substitute
authorizes such sums as may be necessary to carry out these new
and expanded functions. The Managers note that, historically,
HHS has had insufficient resources to properly run the existing
select agent transfer program. While current regulations permit
inspections, only 20 percent of all registered facilities have
been inspected since the inception of the program in 1997, and
virtually none of these inspections were conducted prior to
registration. The Managers also note that HHS received a large
increase in funding for this program in the Fiscal Year 2002
supplemental appropriations bill. Given the broader, but
uncertain scope of the new regulatory regime, it is unclear
whether additional funds beyond current appropriations will be
necessary for Fiscal Year 2003. Once all persons possessing
select agents notify the Secretary of such possession 90 days
after enactment of this title, the appropriations level may
need to be re-evaluated.
Section 202. Implementation by Department of Health and Human Services
House provision: The House bill requires notification to
the Secretary by all persons possessing select agents within 60
days of enactment, and an interim final rule establishing a
regulatory structure to be issued within 120 days of enactment.
Senate amendment: The Senate amendment requires the
Secretary to issue an interim final rule within 180 days of
enactment, and requires all persons possessing select agents to
register within 60 days of issuance of the rule.
Conference substitute: The Conference substitute adopts
the House bill with modifications. The substitute requires
notification to the Secretary by all persons possessing select
agents within 90 days of enactment, based on guidance issued by
the Secretary within 30 days of enactment, and the issuance of
an interim final rule within 180 days of enactment. The
substitute also provides that the interim final rule shall
include time frames for applicability of the rule that minimize
disruption of research or educational projects that involve
select agents and that were underway as of the effective date
of such rule. The Managers note that the interim final rule and
effective date provisions will result in these new regulations
going into effect at approximately the same time as the
National Institutes of Health (NIH) begins to award Fiscal Year
2003 grants for research, some of which will be in the select
agent area. The Managers expect that the Secretary will
encourage those seeking such grants to begin the registration
and screening process under this title concurrently with the
NIH grant process, and that the Secretary will ensure the
timely registration and screening of such grantees, so as not
to delay this important research.
Section 203. Effective Dates
House provision and Senate amendment: Both the House bill
and the Senate amendment provide that regulations promulgated
by the Secretary 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 this Act. They bothalso provide that the FOIA
exemptions apply retroactively to the effective date of the
Antiterrorism and Effective Death Penalty Act of 1996.
Conference substitute: The Conference substitute adopts
the same provisions.
Section 204. Conforming Amendment
House provision and Senate amendment: Both the House bill
and the Senate amendment repeal those provisions of the
Antiterrorism and Effective Death Penalty Act of 1996 that have
been codified in section 351A of the Public Health Service Act
by this Act.
Conference substitute: The Conference substitute adopts
the same provisions.
Subtitle B--Department of Agriculture
Section 211. Short Title
House provision and Senate amendment: Neither the House
bill nor the Senate amendment contain any analogous provision.
Conference substitute: The Conference substitute includes
a new subtitle, with its own short title--the Agricultural
Bioterrorism Protection Act of 2002.
Section 212. Regulation of Certain Biological Agents and Toxins
House provision and Senate amendment: Neither the House
bill nor the Senate amendment contain any analogous provision.
Conference substitute: The Conference substitute adopts
provisions that would grant comparable regulatory authorities
to the U.S. Department of Agriculture (USDA) as those granted
to HHS under subtitle A of this title for the regulation of
possession, use or transfer of listed biological agents and
toxins that present a severe threat to plant or animal health,
or animal or plant products. In an effort to minimize
regulatory duplication and burden, the substitute seeks to
ensure, to the greatest extent practicable, uniformity in the
statutory authority that the two departments will administer.
Exceptions exist in the criteria to be used by the Secretary of
Agriculture in developing a list of agriculturally significant
biological agents and toxins; considerations to be made in
granting exemptions from regulation under the statute;
procedures related to civil monetary penalties; and the time
frames for promulgation of a biological agents and toxins list
and the accompanying requirement that individuals who possess
these agents notify the Secretary of such possession. In
addition, with respect to the screening of persons registering
or accessing listed agents, the substitute uses the same
screening categories as are in subtitle A, but does not mandate
any denials of access, given that possession of USDA-listed
agents by restricted persons is not a Federal crime. Instead,
the Secretary and Attorney General are granted discretion as to
how to proceed in such situations.
The Managers recognize that, under provisions of current
law, biologics manufacturers have had to register, maintain
associated paperwork, and be subject to inspections and
requirements from both USDA and HHS. Likewise, the Managers are
aware that the inadequacy of the penalty provisions of the
Virus-Serum-Toxin Act--enacted in 1913 and under which USDA
currently regulates these dangerous agents--as well as the lack
of authority for the Secretary of Agriculture to regulate
possession of biological agents and toxins that pose a severe
threat to plant or animal health may expose the United States
to potential acts of bioterrorism that could have a devastating
impact on animal and plant health, or the domestic agricultural
economy.
The Managers intend that, in developing the list of
agents and toxins to be regulated under this subtitle, the USDA
Secretary shall consult with other appropriate Federal
agencies. With regard to zoonotic agents, which pose a threat
to both animals and humans, the Managers expect that the USDA
Secretary will consult with the HHS Secretary in developing
such a list. The Managers also intend that the USDA Secretary
will develop the list of regulated agents and toxins based
solely on the risk to animals or plants, or to animal or plant
products, including consideration of the effect of exposure on
the production and marketability of such products. The Managers
do not intend that the USDA Secretary will include an agent or
toxin on the USDA list because of the effect of that agent or
toxin on human health, which is governed by the statutory
provisions of section 351A of the Public Health Service Act, as
amended by this title.
The Managers expect that most "persons" who register
under this subtitle will be public and private entities, rather
than individuals. But these provisions also will cover
individuals possessing, using or transferring listed agents who
have not been granted authority to do so by registered persons.
If an individual has not been granted such authority, then that
individual would be a person required to register under this
subtitle. If an individual has been granted such authority
without proper authorization from the Secretary, as required by
this subtitle, then the registered person is subject to any
penalties provided for violation of such regulations. The
Managers emphasize that the primary responsibility for
registration and the screening of employees working with listed
agents is with the entity or employer, not the individual
employee.
Procedures for the registration of persons, review of
individuals, and inspection of facilities have been described
in the statutory language in some detail. Of equal importance
to the Managers are the regulations, to be established by the
Secretary, which, to ensure compliance with this subtitle,
shall include provisions for the revocation and suspension of
registrations for failure to maintain safe and secure
facilities.
Section 213. Implementation by the Department of Agriculture
House provision and Senate amendment: Neither the House
bill nor the Senate amendment contain any analagous provision.
Conference substitute: The Conference substitute provides
that, within 60 days of enactment, the Secretary of Agriculture
shall promulgate an interim final rule that establishes an
initial list of agents and toxins meeting the statutory
criteria for enhanced regulation. Within 60 days of the
publishing of the interim final rule, all persons (unless
exempt) must notify the Secretary of such possession. Within
180 days of enactment, the Secretary shall promulgate an
interim final rule for carrying out the remainder of section
212, which such rule shall include time frames that minimize
disruption of ongoing research and education with listed agents
and toxins.
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