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.

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       JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF CONFERENCE

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 TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

          Subtitle A--Department of Health and Human Services

Section 201. Regulation of Certain Biological Agents and Toxins
      House provision: The House bill requires all persons who 
possess, use or transfer "select agents"--the 36 biological 
agents or toxins currently determined by the Secretary of the 
Department of Health and Human Services (HHS) to pose "a 
severe threat to public health and safety"--to register with 
the Secretary and be subject to reasonable safety and security 
requirements and inspections. Current law requires registration 
only of those entities transferring such agents. The House bill 
also directs that the Secretary maintain a national database of 
all such agents, with sufficient information to facilitate 
their identification and traceability. The Secretary, in 
consultation with the Attorney General, must establish specific 
security requirements for registered facilities and a personnel 
screening protocol to ensure that access to such agents is not 
permitted by individuals who are "restricted persons" under 
the USA PATRIOT Act (18 U.S.C. 175b), are named in a warrant 
for violent criminal or terrorist activity, are under 
investigation for involvement in domestic or international 
terrorist or criminal organizations, or suspected of spying for 
the military or intelligence operations of a foreign nation. 
The Secretary is granted authority to assist public and 
nonprofit private entities in meeting such security 
requirements. The House bill also imposes civil penalties for 
those who violate the regulations, up to $500,000.
      The House bill grants the Secretary discretion to make 
exemptions to the registration requirements only where those 
exemptions are consistent with protecting the public health and 
safety--for example, with respect to inactivated or attenuated 
strains of select agents used in vaccines or other products for 
legitimate medical research or use--or when the agent is 
presented for diagnosis, verification or proficiency testing 
purposes at a clinical laboratory and is promptly destroyed or 
transferred to a registered facility after such identification. 
The House bill also exempts from mandatory disclosure under the 
Freedom of Information Act (FOIA) site-specific or identifying 
information submitted under these regulations concerning 
registered persons, select agents, and security mechanisms.
      Senate amendment: The Senate amendment is substantially 
similar to the House bill but differs in a few respects. First, 
in developing the list of select agents, the Secretary is 
directed to consider the needs of children and other vulnerable 
populations. Second, individuals who seek access to select 
agents are screened only to identify if they are "restricted 
persons" under the USA PATRIOT Act, or are named in a warrant 
for participation in a domestic or international act of 
terrorism. Third, the Secretary is permitted to exempt certain 
attenuated or inactive biological agents or toxins and certain 
approved medical products from the list of select agents.
      Conference substitute: The Conference substitute adopts 
provisions of both bills, with significant modifications. The 
primary goals of this subtitle are to ensure the prompt 
reporting to the Federal government of possession of select 
agents (including by those who were in possession prior to 
April 15, 1997, the effective date for reporting transfers of 
select agents), to increase the security over such agents 
(including access controls and screening of personnel), and to 
establish a comprehensive and detailed national database of the 
location and characterization of such agents and the identities 
of those in possession of them. To effectuate these goals, the 
substitute requires that, at a minimum, all possession of 
select agents (unless exempt under the provisions of this 
subtitle) must be registered with the Secretary. The Managers 
expect that most "persons" who register under this subtitle 
will be public and private entities, rather than individuals. 
But these provisions also will cover individuals possessing, 
using or transferring select agents who have not been granted 
authority to do so by registered persons. If an individual has 
not been granted such authority, then that individual would be 
a person required to register under this subtitle. If an 
individual has been granted such authority without proper 
authorization from the Secretary, as required by this subtitle, 
then the registered person is subject to any penalties provided 
for violation of such regulations. The Managers emphasize that 
the primary responsibility for registration and the screening 
of employees working with select agents is with the entity or 
employer, not the individual employee. The Secretary also is 
required to promulgate regulations establishing safety 
requirements for the possession, use, and transfer of select 
agents. These regulations must include procedures to protect 
the public safety in the event the safety requirements for 
possession, use or transfer are violated.
      The Managers recognize that some select agents may pose a 
greater threat to the public health and safety than others. 
Accordingly, the Conference substitute amends the security 
requirements of both bills by adding the phrase "commensurate 
with the risk such agent or toxin poses to public health and 
safety (including the risk of use in domestic or international 
terrorism)." The Secretary will have flexibility to impose 
different levels of security requirements on different select 
agents based on his or her evaluation of the level of threat to 
the public, as is currently done with respect to laboratory 
biosafety levels. Because an agent must pose a severe threat to 
human health to be placed on the select agent list, the 
Secretary may not decide that security requirements or 
registration of possession are unnecessary for a particular 
select agent.
      The substitute also modifies the existing statutory 
requirements for the transfer regulations by adding "and 
security measures" after "safeguards" in the term 
"safeguards to prevent access . . . for use in domestic or 
international terrorism or for any other criminal purposes" to 
clarify that such regulations include the imposition of 
security requirements. The substitute also requires that 
registered persons promptly notify the Secretary whenever a 
select agent is lost, stolen, or released outside of a 
biocontainment area of a facility. Current HHS regulations do 
not mandate such notifications.
      The Conference substitute adds new provisions regarding 
the screening of entities and individuals seeking to register 
their possession, use or transfer of select agents. While both 
the House and Senate bills mandate screening of individuals 
seeking access to agents through a registered person, neither 
bill required screening of the registered persons themselves. 
The substitute provides for such screening in a similar manner 
to that performed for individuals working at the facilities of 
registered persons. Further with respect to screening, the 
substitute drops the provision in both bills relating to 
outstanding warrants, as duplicative of the fugitive provision 
in the restricted person categories of the USA PATRIOT Act, and 
adds a screening category that was in neither bill--those 
reasonably suspected of committing Federal crimes of terrorism. 
The substitute includes but makes revisions to the two 
additional screening categories contained in the House bill to 
ensure an objective basis for governmental suspicion of 
involvement with terrorist or criminal organizations, or with 
foreign powers. In the case of restricted persons, the 
substitute mandates that access to select agents be denied, 
because of the criminal prohibition on possession by such 
persons. In the case ofpersons falling within the other three 
specified categories, the substitute grants the Secretary and Attorney 
General discretion in determining how to proceed, given the law 
enforcement sensitivity of such situations. By making this distinction 
between the handling of restricted persons and other screening 
categories, the Managers do not intend that potential terrorists or 
foreign agents should be subject to a less strict screening standard 
than restricted persons. The substitute also clarifies that the 
screening performed by the Attorney General is for the sole purpose of 
identifying--through the use of official, electronic databases 
available to the Federal government--whether an individual or entity 
falls within any of the specified categories, and for notifying the HHS 
Secretary of such identification. It is the Managers' intent that the 
term "electronic databases" is not meant to preclude the use of other 
databases or files by the Attorney General to clarify or confirm 
information obtained during the electronic database search.
      To address concerns within the academic and research 
communities about the timeliness and accuracy of the background 
screening process, the Conference substitute amends both bills 
by requiring "prompt" action by the Attorney General and the 
Secretary with respect to screening of and notification to 
affected individuals, and by providing for an expedited review 
process where good cause has been demonstrated by the 
registered person. The substitute also provides for a review of 
denials by the Secretary based on the screening process, and 
subsequent judicial review--with provisions to ensure that 
classified or sensitive law enforcement information is not 
compromised during such reviews. Specifically, the substitute 
allows for ex parte review by the Secretary in administrative 
proceedings, and the court during judicial review, whenever a 
denial is challenged. In providing the right for ex parte 
review, the Managers intend to protect classified and law 
enforcement sensitive information, including through the use of 
in camera proceedings. Moreover, the Managers intend that a 
reviewing court should not order the disclosure of any 
information that the United States believes may compromise 
national security or an ongoing law enforcement investigation 
without affording the United States an opportunity for further 
review in accordance with this subtitle. It is the Managers' 
overall expectation that the screening process be conducted in 
a timely and fair manner, and that the Secretary and the 
Attorney General will work closely together to effectuate such 
intent.
      With respect to the national database of select agents 
that the Secretary must develop pursuant to this section, the 
Conference substitute slightly alters the language used in both 
bills with respect to the database's purpose. The object of the 
registration and database requirements is to provide 
information about all persons possessing, using or transferring 
select agents, and to collect sufficiently detailed 
characterization information on the registered select agents so 
that the database can differentiate between and within strains 
of a given agent or toxin. Such information should be in a 
format that public health and law enforcement officials can use 
to identify the origin or source of an agent or toxin that is 
used to cause harm to the public. Because of concerns over the 
potential for misconstruction, the term "traceability"--which 
could imply a chain of custody or tracking requirement--was 
eliminated, and was replaced with the concept of "source."
      Significant modifications were made to both bills with 
respect to exemptions from the statutory and regulatory 
requirements governing select agents. The Conference substitute 
establishes several exemptions from the regulatory regime for 
select agents, most of which are consistent with the 
Secretary's current regulations and practices. First, the 
Conference substitute adopts, with modifications, the Senate 
amendment's language with respect to product exemptions. The 
substitute directs the Secretary to exempt from such 
regulations products that are, bear or contain a select agent 
and are licensed or approved under several specified Federal 
laws, unless the Secretary determines that additional 
regulation is necessary for a specific product to ensure 
protection of public health and safety. The Managers intend 
that the Secretary will exempt by regulation categories of 
products, consistent with current regulations, and will act to 
regulate a specific product, or a particular application of a 
specific product, only when existing regulation under other 
Federal laws is inadequate. For example, HHS currently exempts 
the FDA-approved medical product Botox, which is the select 
agent botulinum toxin, when it is used by licensed physicians 
in the treatment of patients. However, when it is used in 
purely research settings or as part of early-stage clinical 
trials, HHS has chosen not to exempt Botox from current 
regulations. The Managers do not intend to alter this 
flexibility.
      Second, the Conference substitute adds a provision 
granting the Secretary discretionary authority to exempt, on a 
case-by-case basis, investigational products when they are 
being used in investigational or clinical trials authorized 
under other Federal laws, such as the Federal Food, Drug, and 
Cosmetic Act. Given the time sensitivity of such trials, the 
substitute also includes a provision mandating a prompt 
determinationby the Secretary of such an exemption request--
within 14 days after the applicant has submitted a complete exemption 
request and has notified the Secretary that the investigation may 
proceed as authorized under Federal law.
      Third, with respect to clinical or diagnostic 
laboratories that may come into possession of select agents 
when conducting specimen diagnosis, verification or proficiency 
testing, the substitute adopts with minor changes the 
comparable provisions in the House and Senate bills. The 
Secretary shall exempt such laboratories from registration 
requirements, but only if they report the identification of 
select agents to the Secretary and either promptly transfer the 
agent to a registered person or destroy the agent on site, in 
accordance with regulations established by the Secretary. While 
HHS currently exempts such laboratories, existing regulations 
permit them to transfer, destroy, or store the agent on site 
for reference purposes. The Conference substitute expressly 
rejects that regulatory approach, as it is inconsistent with 
the fundamental premise of this title--that all those who 
maintain possession of a select agent must register and be 
subject to appropriate security and safety requirements. The 
Secretary may not exempt laboratories that possess select 
agents for reference purposes, or any other clinical or 
diagnostic laboratories that do not qualify for an exemption 
under the terms of this title. In addition, the Conference 
substitute creates two temporary exemption authorities to deal 
with public health emergencies and agricultural emergencies, 
whether domestic or foreign.
      With respect to funding, the Conference substitute 
authorizes such sums as may be necessary to carry out these new 
and expanded functions. The Managers note that, historically, 
HHS has had insufficient resources to properly run the existing 
select agent transfer program. While current regulations permit 
inspections, only 20 percent of all registered facilities have 
been inspected since the inception of the program in 1997, and 
virtually none of these inspections were conducted prior to 
registration. The Managers also note that HHS received a large 
increase in funding for this program in the Fiscal Year 2002 
supplemental appropriations bill. Given the broader, but 
uncertain scope of the new regulatory regime, it is unclear 
whether additional funds beyond current appropriations will be 
necessary for Fiscal Year 2003. Once all persons possessing 
select agents notify the Secretary of such possession 90 days 
after enactment of this title, the appropriations level may 
need to be re-evaluated.
Section 202. Implementation by Department of Health and Human Services
      House provision: The House bill requires notification to 
the Secretary by all persons possessing select agents within 60 
days of enactment, and an interim final rule establishing a 
regulatory structure to be issued within 120 days of enactment.
      Senate amendment: The Senate amendment requires the 
Secretary to issue an interim final rule within 180 days of 
enactment, and requires all persons possessing select agents to 
register within 60 days of issuance of the rule.
      Conference substitute: The Conference substitute adopts 
the House bill with modifications. The substitute requires 
notification to the Secretary by all persons possessing select 
agents within 90 days of enactment, based on guidance issued by 
the Secretary within 30 days of enactment, and the issuance of 
an interim final rule within 180 days of enactment. The 
substitute also provides that the interim final rule shall 
include time frames for applicability of the rule that minimize 
disruption of research or educational projects that involve 
select agents and that were underway as of the effective date 
of such rule. The Managers note that the interim final rule and 
effective date provisions will result in these new regulations 
going into effect at approximately the same time as the 
National Institutes of Health (NIH) begins to award Fiscal Year 
2003 grants for research, some of which will be in the select 
agent area. The Managers expect that the Secretary will 
encourage those seeking such grants to begin the registration 
and screening process under this title concurrently with the 
NIH grant process, and that the Secretary will ensure the 
timely registration and screening of such grantees, so as not 
to delay this important research.
Section 203. Effective Dates
      House provision and Senate amendment: Both the House bill 
and the Senate amendment provide that regulations promulgated 
by the Secretary under section 511 of the Antiterrorism and 
Effective Death Penalty Act of 1996 are deemed to have been 
promulgated under section 351A of the Public Health Service 
Act, as added by this Act. They bothalso provide that the FOIA 
exemptions apply retroactively to the effective date of the 
Antiterrorism and Effective Death Penalty Act of 1996.
      Conference substitute: The Conference substitute adopts 
the same provisions.
Section 204. Conforming Amendment
      House provision and Senate amendment: Both the House bill 
and the Senate amendment repeal those provisions of the 
Antiterrorism and Effective Death Penalty Act of 1996 that have 
been codified in section 351A of the Public Health Service Act 
by this Act.
      Conference substitute: The Conference substitute adopts 
the same provisions.

                 Subtitle B--Department of Agriculture

Section 211. Short Title
      House provision and Senate amendment: Neither the House 
bill nor the Senate amendment contain any analogous provision.
      Conference substitute: The Conference substitute includes 
a new subtitle, with its own short title--the Agricultural 
Bioterrorism Protection Act of 2002.
Section 212. Regulation of Certain Biological Agents and Toxins
      House provision and Senate amendment: Neither the House 
bill nor the Senate amendment contain any analogous provision.
      Conference substitute: The Conference substitute adopts 
provisions that would grant comparable regulatory authorities 
to the U.S. Department of Agriculture (USDA) as those granted 
to HHS under subtitle A of this title for the regulation of 
possession, use or transfer of listed biological agents and 
toxins that present a severe threat to plant or animal health, 
or animal or plant products. In an effort to minimize 
regulatory duplication and burden, the substitute seeks to 
ensure, to the greatest extent practicable, uniformity in the 
statutory authority that the two departments will administer. 
Exceptions exist in the criteria to be used by the Secretary of 
Agriculture in developing a list of agriculturally significant 
biological agents and toxins; considerations to be made in 
granting exemptions from regulation under the statute; 
procedures related to civil monetary penalties; and the time 
frames for promulgation of a biological agents and toxins list 
and the accompanying requirement that individuals who possess 
these agents notify the Secretary of such possession. In 
addition, with respect to the screening of persons registering 
or accessing listed agents, the substitute uses the same 
screening categories as are in subtitle A, but does not mandate 
any denials of access, given that possession of USDA-listed 
agents by restricted persons is not a Federal crime. Instead, 
the Secretary and Attorney General are granted discretion as to 
how to proceed in such situations.
      The Managers recognize that, under provisions of current 
law, biologics manufacturers have had to register, maintain 
associated paperwork, and be subject to inspections and 
requirements from both USDA and HHS. Likewise, the Managers are 
aware that the inadequacy of the penalty provisions of the 
Virus-Serum-Toxin Act--enacted in 1913 and under which USDA 
currently regulates these dangerous agents--as well as the lack 
of authority for the Secretary of Agriculture to regulate 
possession of biological agents and toxins that pose a severe 
threat to plant or animal health may expose the United States 
to potential acts of bioterrorism that could have a devastating 
impact on animal and plant health, or the domestic agricultural 
economy.
      The Managers intend that, in developing the list of 
agents and toxins to be regulated under this subtitle, the USDA 
Secretary shall consult with other appropriate Federal 
agencies. With regard to zoonotic agents, which pose a threat 
to both animals and humans, the Managers expect that the USDA 
Secretary will consult with the HHS Secretary in developing 
such a list. The Managers also intend that the USDA Secretary 
will develop the list of regulated agents and toxins based 
solely on the risk to animals or plants, or to animal or plant 
products, including consideration of the effect of exposure on 
the production and marketability of such products. The Managers 
do not intend that the USDA Secretary will include an agent or 
toxin on the USDA list because of the effect of that agent or 
toxin on human health, which is governed by the statutory 
provisions of section 351A of the Public Health Service Act, as 
amended by this title.
      The Managers expect that most "persons" who register 
under this subtitle will be public and private entities, rather 
than individuals. But these provisions also will cover 
individuals possessing, using or transferring listed agents who 
have not been granted authority to do so by registered persons. 
If an individual has not been granted such authority, then that 
individual would be a person required to register under this 
subtitle. If an individual has been granted such authority 
without proper authorization from the Secretary, as required by 
this subtitle, then the registered person is subject to any 
penalties provided for violation of such regulations. The 
Managers emphasize that the primary responsibility for 
registration and the screening of employees working with listed 
agents is with the entity or employer, not the individual 
employee.
      Procedures for the registration of persons, review of 
individuals, and inspection of facilities have been described 
in the statutory language in some detail. Of equal importance 
to the Managers are the regulations, to be established by the 
Secretary, which, to ensure compliance with this subtitle, 
shall include provisions for the revocation and suspension of 
registrations for failure to maintain safe and secure 
facilities.
Section 213. Implementation by the Department of Agriculture
      House provision and Senate amendment: Neither the House 
bill nor the Senate amendment contain any analagous provision.
      Conference substitute: The Conference substitute provides 
that, within 60 days of enactment, the Secretary of Agriculture 
shall promulgate an interim final rule that establishes an 
initial list of agents and toxins meeting the statutory 
criteria for enhanced regulation. Within 60 days of the 
publishing of the interim final rule, all persons (unless 
exempt) must notify the Secretary of such possession. Within 
180 days of enactment, the Secretary shall promulgate an 
interim final rule for carrying out the remainder of section 
212, which such rule shall include time frames that minimize 
disruption of ongoing research and education with listed agents 
and toxins.

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