Agricultural Bioterrorism Protection Act of 2002 (Pub. L. 107–188, title II, subtitle B)

116 STAT. 647PUBLIC LAW 107–188—JUNE 12, 2002 (1) section 175b(c) of title 18, United States Code (relating to criminal penalties), as added by section 231(a)(5) of this Act; and (2) section 351A(i) of the Public Health Service Act (relating to civil penalties). (c) TRANSITIONAL PROVISION REGARDING CURRENT RESEARCH AND EDUCATION.—The interim final rule under subsection (b) shall include time frames for the applicability of the rule that minimize disruption of research or educational projects that involve biological agents and toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act and that were underway as of the effective date of such rule. SEC. 203. EFFECTIVE DATES. (a) IN GENERAL.—Regulations promulgated by the Secretary of Health and Human Services under section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 are deemed to have been promulgated under section 351A of the Public Health Service Act, as added by section 201 of this Act. Such regulations, including the list under subsection (d)(1) of such section 511, that were in effect on the day before the date of the enactment of this Act remain in effect until modified by the Secretary in accord ance with such section 351A and with section 202 of this Act. (b) EFFECTIVE DATE REGARDING DISCLOSURE OF INFORMA TION.—Subsection (h) of section 351A of the Public Health Service Act, as added by section 201 of this Act, is deemed to have taken effect on the effective date of the Antiterrorism and Effective Death Penalty Act of 1996. SEC. 204. CONFORMING AMENDMENT. Subsections (d), (e), (f), and (g) of section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 (42 U.S.C. 262 note) are repealed. Subtitle B—Department of Agriculture SEC. 211. SHORT TITLE. This subtitle may be cited as the ‘‘Agricultural Bioterrorism Protection Act of 2002’’. SEC. 212. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS. (a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.— (1) LIST OF BIOLOGICAL AGENTS AND TOXINS.— (A) IN GENERAL.—The Secretary of Agriculture shall by regulation establish and maintain a list of each biological agent and each toxin that the Secretary deter mines has the potential to pose a severe threat to animal or plant health, or to animal or plant products. (B) CRITERIA.—In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall— (i) consider— (I) the effect of exposure to the agent or toxin on animal or plant health, and on the production and marketability of animal or plant products; 7 USC 8401. 7 USC 8401 note. Agricultural Bioterrorism Protection Act of 2002. 42 USC 262a note. VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00055 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 648 PUBLIC LAW 107–188—JUNE 12, 2002 (II) the pathogenicity of the agent or the tox icity of the toxin and the methods by which the agent or toxin is transferred to animals or plants; (III) the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; and (IV) any other criteria that the Secretary con siders appropriate to protect animal or plant health, or animal or plant products; and (ii) consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups. (2) BIENNIAL REVIEW.—The Secretary shall review and republish the list under paragraph (1) biennially, or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph. (b) REGULATION OF TRANSFERS OF LISTED AGENTS AND TOXINS.—The Secretary shall by regulation provide for— (1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure— (A) proper training and appropriate skills to handle such agents and toxins; and (B) proper laboratory facilities to contain and dispose of such agents and toxins; (2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose; (3) the establishment of procedures to protect animal and plant health, and animal and plant products, in the event of a transfer or potential transfer of such an agent or toxin in violation of the safety procedures established under para graph (1) or the safeguard and security measures established under paragraph (2); and (4) appropriate availability of biological agents and toxins for research, education, and other legitimate purposes. (c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.— The Secretary shall by regulation provide for the establishment and enforcement of standards and procedures governing the posses sion and use of listed agents and toxins, including the provisions described in paragraphs (1) through (4) of subsection (b), in order to protect animal and plant health, and animal and plant products. (d) REGISTRATION; IDENTIFICATION; DATABASE.— (1) REGISTRATION.—Regulations under subsections (b) and (c) shall require registration with the Secretary of the posses sion, use, and transfer of listed agents and toxins, and shall include provisions to ensure that persons seeking to register under such regulations have a lawful purpose to possess, use, or transfer such agents and toxins, including provisions in accordance with subsection (e)(6). (2) IDENTIFICATION; DATABASE.—Regulations under sub sections (b) and (c) shall require that registration include (if available to the person registering) information regarding the characterization of listed agents and toxins to facilitate their Safety. Publication. VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00056 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 649PUBLIC LAW 107–188—JUNE 12, 2002 identification, including their source. The Secretary shall main tain a national database that includes the names and locations of registered persons, the listed agents and toxins such persons are possessing, using, or transferring, and information regarding the characterization of such agents and toxins. (e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED PERSONS.— (1) IN GENERAL.—Regulations under subsections (b) and (c) shall include appropriate safeguard and security require ments for persons possessing, using, or transferring a listed agent or toxin commensurate with the risk such agent or toxin poses to animal and plant health, and animal and plant prod ucts (including the risk of use in domestic or international terrorism). The Secretary shall establish such requirements in consultation with the Attorney General, and shall ensure compliance with such requirements as part of the registration system under such regulations. (2) LIMITING ACCESS TO LISTED AGENTS AND TOXINS.— Requirements under paragraph (1) shall include provisions to ensure that registered persons— (A) provide access to listed agents and toxins to only those individuals whom the registered person involved determines have a legitimate need to handle or use such agents and toxins; (B) submit the names and other identifying information for such individuals to the Secretary and the Attorney General, promptly after first determining that the individ uals need access under subparagraph (A), and periodically thereafter while the individuals have such access, not less frequently than once every five years; and (C)(i) in the case of listed agents and toxins that are not overlap agents and toxins (as defined in subsection (g)(1)(A)(ii)), limit or deny access to such agents and toxins by individuals whom the Attorney General has identified as within any category under paragraph (3)(B), if limiting or denying such access by the individuals involved is deter mined appropriate by the Secretary, in consultation with the Attorney General; and (ii) in the case of listed agents and toxins that are overlap agents— (I) deny access to such agents and toxins by individuals whom the Attorney General has identi fied as within any category referred to in para graph (3)(B)(i); and (II) limit or deny access to such agents and toxins by individuals whom the Attorney General has identified as within any category under para graph (3)(B)(ii), if limiting or denying such access by the individuals involved is determined appro priate by the Secretary, in consultation with the Attorney General. (3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY GENERAL.— (A) IN GENERAL.—Upon the receipt of names and other identifying information under paragraph (2)(B), the Attorney General shall, for the sole purpose of identifying whether the individuals involved are within any of the Records. VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00057 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 650 PUBLIC LAW 107–188—JUNE 12, 2002 categories specified in subparagraph (B), promptly use criminal, immigration, national security, and other elec tronic databases that are available to the Federal Govern ment and are appropriate for such purpose. (B) CERTAIN INDIVIDUALS.—For purposes of subpara graph (A), the categories specified in this subparagraph regarding an individual are that— (i) the individual is within any of the categories described in section 175b(d)(1) of title 18, United States Code (relating to restricted persons); or (ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of— (I) committing a crime set forth in section 2332b(g)(5) of title 18, United States Code; (II) knowing involvement with an organization that engages in domestic or international terrorism (as defined in section 2331 of such title 18) or with any other organization that engages in inten tional crimes of violence; or (III) being an agent of a foreign power (as defined in section 1801 of title 50, United States Code). (C) NOTIFICATION BY ATTORNEY GENERAL REGARDING SUBMITTED NAMES.—After the receipt of a name and other identifying information under paragraph (2)(B), the Attorney General shall promptly notify the Secretary whether the individual is within any of the categories specified in subparagraph (B). (4) NOTIFICATIONS BY SECRETARY.—The Secretary, after receiving notice under paragraph (3) regarding an individual, shall promptly notify the registered person involved of whether the individual is granted or denied access under paragraph (2). If the individual is denied such access, the Secretary shall promptly notify the individual of the denial. (5) EXPEDITED REVIEW.—Regulations under subsections (b) and (c) shall provide for a procedure through which, upon request to the Secretary by a registered person who submits names and other identifying information under paragraph (2)(B) and who demonstrates good cause, the Secretary may, as determined appropriate by the Secretary— (A) request the Attorney General to expedite the process of identification under paragraph (3)(A) and notification of the Secretary under paragraph (3)(C); and (B) expedite the notification of the registered person by the Secretary under paragraph (4). (6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.— (A) INDIVIDUALS.—Regulations under subsections (b) and (c) shall provide that an individual who seeks to reg ister under either of such subsections is subject to the same processes described in paragraphs (2) through (4) as apply to names and other identifying information sub mitted to the Attorney General under paragraph (2)(B). Paragraph (5) does not apply for purposes of this subpara graph. (B) OTHER PERSONS.—Regulations under subsections (b) and (c) shall provide that, in determining whether to deny or revoke registration by a person other than an VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00058 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 651PUBLIC LAW 107–188—JUNE 12, 2002 individual, the Secretary shall submit the name of such person to the Attorney General, who shall use criminal, immigration, national security, and other electronic data bases 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 sus pected 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 reg ister 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 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 rel evant to the review ex parte to the extent that disclo sure 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 Sec retary 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 disclo sure 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 speci fied items of information the disclosure of which could compromise national security or an investigation by VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00059 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 652 PUBLIC LAW 107–188—JUNE 12, 2002 any law enforcement agency, or to substitute a sum mary of the information to which the person may respond. Any order by the court authorizing the disclo sure 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 consid eration). (ii) DISCLOSURE OF INFORMATION.—In a review under subparagraph (A), and in any judical proceeding conducted pursuant to such review, neither the Sec retary nor the Attorney General may be required to disclose to the public any information that under sub section (h) shall not be disclosed under section 552 of title 5, United States Code. (8) NOTIFICATIONS REGARDING THEFT OR LOSS OF AGENTS.— Requirements under paragraph (1) shall include the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins. (9) TECHNICAL ASSISTANCE FOR REGISTERED PERSONS.—The Secretary, in consultation with the Attorney General, may pro vide technical assistance to registered persons to improve secu rity of the facilities of such persons. (f) INSPECTIONS.—The Secretary shall have the authority to inspect persons subject to regulations under subsection (b) or (c) to ensure their compliance with such regulations, including prohibi tions on restricted persons and other provisions of subsection (e). (g) EXEMPTIONS.— (1) 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.—Regula tions 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 pro ficiency testing, provided that— VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00060 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 653PUBLIC LAW 107–188—JUNE 12, 2002 (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 con tains an overlap agent or toxin from the applica bility 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 addi tional 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 proce dures for applying for an exemption under sub clause (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 Sec retary 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 VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00061 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 654 PUBLIC LAW 107–188—JUNE 12, 2002 requirements of this section with respect to an overlap agent or toxin, in whole or in part, if the Secretary deter mines 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 deter mines 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 sub mitted 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 identi fies 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 sub section (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 meas ures used by a registered person to prevent unauthorized access to listed agents and toxins. (D) Any notification of a release of a listed agent or toxin submitted under subsections (b) and (c), or any VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00062 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 655PUBLIC LAW 107–188—JUNE 12, 2002 notification of theft or loss submitted under such sub sections. (E) Any portion of an evaluation or report of an inspec tion of a specific registered person conducted under sub section (f) that identifies the listed agent or toxin possessed by a specific registered person or that discloses the identity or location of a specific registered person if the agency determines that public disclosure of the information would endanger animal or plant health, or animal or plant prod ucts. (2) COVERED AGENCIES.—For purposes of paragraph (1) only, the Federal agencies specified in this paragraph are the following: (A) The Department of Health and Human Services, the Department of Justice, the Department of Agriculture, and the Department of Transportation. (B) Any Federal agency to which information specified in paragraph (1) is transferred by any agency specified in subparagraph (A) of this paragraph. (C) Any Federal agency that is a registered person, or has a sub-agency component that is a registered person. (D) Any Federal agency that awards grants or enters into contracts or cooperative agreements involving listed agents and toxins to or with a registered person, and to which information specified in paragraph (1) is trans ferred by any such registered person. (3) OTHER EXEMPTIONS.—This subsection may not be con strued as altering the application of any exemptions to public disclosure under section 552 of title 5, United States Code, except as to subsection 552(b)(3) of such title, to any of the information specified in paragraph (1). (4) RULE OF CONSTRUCTION.—Except as specifically pro vided in paragraph (1), this subsection may not be construed as altering the authority of any Federal agency to withhold under section 552 of title 5, United States Code, or the obliga tion of any Federal agency to disclose under section 552 of title 5, United States Code, any information, including informa tion relating to— (A) listed agents and toxins, or individuals seeking access to such agents and toxins; (B) registered persons, or persons seeking to register their possession, use, or transfer of such agents and toxins; (C) general safeguard and security policies and require ments under regulations under subsections (b) and (c); or (D) summary or statistical information concerning reg istrations, registrants, denials or revocations of registra tions, listed agents and toxins, inspection evaluations and reports, or individuals seeking access to such agents and toxins. (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.— VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00063 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 656 PUBLIC LAW 107–188—JUNE 12, 2002 (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 Protec tion 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 sub section (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 Agri culture. (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 Rules. 7 USC 8401 note. Deadlines. VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00064 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28 116 STAT. 657PUBLIC LAW 107–188—JUNE 12, 2002 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. Subtitle C—Interagency Coordination Regarding Overlap Agents and Toxins SEC. 221. INTERAGENCY COORDINATION. (a) IN GENERAL.— (1) COORDINATION.—The Secretary of Agriculture and the Secretary of Health and Human Services shall in accordance with this section coordinate activities regarding overlap agents and toxins. (2) OVERLAP AGENTS AND TOXINS; OTHER TERMS.—For pur poses of this section: (A) The term ‘‘overlap agent or toxin’’ means a biological agent or toxin that— (i) is listed pursuant to section 315A(a)(1) of the Public Health Service Act, as added by section 201 of this Act; and (ii) is listed pursuant to section 212(a)(1) of this Act. (B) The term ‘‘section 351A program’’ means the pro gram under section 351A of the Public Health Service Act. (C) The term ‘‘section 212 program’’ means the program under section 212 of this Act. (b) CERTAIN MATTERS.—In carrying out the section 351A pro gram and the section 212 program, the Secretary of Health and Human Services and the Secretary of Agriculture shall, to the 7 USC 8411. Rules. Guidelines. VerDate 11-MAY-2000 08:43 Jul 03, 2002 Jkt 000000 PO 00000 Frm 00065 Fmt 6580 Sfmt 6581 PUBL188.107 APPS28 PsN: APPS28