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. [...]