To amend the Antiterrorism and Effective Death Penalty Act of 1996 with respect to the responsibilities of the Secretary of Health and Human Services regarding biological agents and toxins, and to amend title 18, United States Code, with respect to such agents and toxins.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Bioterrorism Prevention Act of 
2001''.

SEC. 2. EXPANSION OF BIOLOGICAL WEAPONS STATUTE.

    (a) Select Agents.--
            (1) In general.--Section 175 of title 18, United States 
        Code, is amended--
                    (A) by redesignating subsection (b) as subsection 
                (c); and
                    (B) by inserting after subsection (a) the following 
                subsection:
    ``(b) Select Agents.--
            ``(1) Unsafe handling.--
                    ``(A) In general.--Whoever possesses, uses, or 
                exercises control over a select agent in a manner 
                constituting reckless disregard for the public health 
                and safety, knowing the select agent to be a biological 
                agent or toxin, shall be fined under this title, 
                imprisoned for not more than one year, or both.
                    ``(B) Aggravated offense.--Whoever, in the course 
                of a violation of subparagraph (A), causes bodily 
                injury to another shall be fined under this title, or 
                imprisoned for not more than 10 years, or both; except 
                that if death results from such violation, the person 
                committing the violation shall be fined under this 
                title, or imprisoned for any term of years or for life, 
                or both.
            ``(2) Unregistered for possession.--Whoever knowingly 
        possesses a biological agent or toxin where such agent or toxin 
        is a select agent for which such person has not obtained a 
        registration under section 511(f) of the Antiterrorism and 
        Effective Death Penalty Act of 1996 shall be fined under this 
        title, or imprisoned for not more than 5 years, or both.
            ``(3) Transfer to unregistered person.--Whoever knowingly 
        transfers a select agent to a person who has not obtained a 
        registration under section 511(e) of the Antiterrorism and 
        Effective Death Penalty Act of 1996 shall be fined under this 
        title, or imprisoned for not more than 5 years, or both.
            ``(4) Restricted persons.--Whoever is a restricted person 
        and knowingly ships or transports a select agent in interstate 
        or foreign commerce, or knowingly receives a select agent so 
        shipped or transported, or knowingly possesses a select agent 
        in or affecting interstate or foreign commerce, shall be fined 
        under this title, or imprisoned for not more than 5 years, or 
        both. The preceding sentence does not apply with respect to any 
        duly authorized governmental activity under title V of the 
        National Security Act of 1947.''.
            (2) Definitions.--Section 175 of title 18, United States 
        Code, as amended by paragraph (1) of this subsection, is 
        amended by amending subsection (c) to read as follows:
    ``(c) Definitions.--As used in this section:
            ``(1) The terms `biological agent' and `toxin' have the 
        meanings given such terms in section 178, except that, for 
        purposes of subsection (b), such terms do not encompass any 
        biological agent or toxin that is in its naturally occurring 
        environment, if the biological agent or toxin has not been 
        cultivated, cultured, collected, or otherwise extracted from 
        its natural source.
            ``(2) The term `bodily injury' has the meaning given such 
        term in section 1365.
            ``(3) The term `for use as a weapon' includes the 
        development, production, transfer, acquisition, retention, or 
        possession of any biological agent, toxin, or delivery system, 
        other than for prophylactic, protective, or other peaceful 
        purposes.
            ``(4)(A) The term `restricted person' means a person--
                    ``(i) who is described in section 922(g), as such 
                section was in effect on the day before the effective 
                date of this paragraph; or
                    ``(ii) who is an alien, other than an alien 
                lawfully admitted for permanent residence or an alien 
                who under subparagraph (B) is considered not to be a 
                restricted person.
            ``(B) For purposes of subparagraph (A)(ii):
                    ``(i) An alien is considered not to be a restricted 
                person if the alien is within a category designated 
                under clause (ii) of this subparagraph.
                    ``(ii) The Secretary of Health and Human Services, 
                in consultation with the Attorney General, may 
                designate categories of individuals who have--
                            ``(I) nonimmigrant visas as defined in 
                        section 101(a)(26) of the Immigration and 
                        Nationality Act; and
                            ``(II) expertise valuable to the United 
                        States regarding select agents.
            ``(5) The term `select agent' means a biological agent or 
        toxin, as defined in paragraph (1), that--
                    ``(A) is on the list that is in effect pursuant to 
                section 511(d)(1) of the Antiterrorism and Effective 
                Death Penalty Act of 1996 (Public Law 104-132); and
                    ``(B) has not been exempted from the applicability 
                of regulations under section 511(e) of such Act.''.
            (3) Effective date regarding restricted persons; 
        regulations.--
                    (A) Effective date.--Section 175(b)(4) of title 18, 
                United States Code, as added by subsection (a)(1)(B) of 
                this section, takes effect upon the expiration of the 
                90-day period beginning on the date of the enactment of 
                this Act.
                    (B) Regulations.--Not later than 30 days after the 
                date of the enactment of this Act, the Secretary of 
                Health and Human Services shall determine whether the 
                Secretary will designate any categories or individuals 
                for purposes of section 175(c)(4)(B) of title 18, 
                United States Code, as added by subsection (a)(1)(B) of 
                this section. If the Secretary determines that one or 
                more such categories will be designated, the Secretary 
                shall promulgate an interim final rule for purposes of 
                such section not later than 60 days after such date of 
                enactment.
            (4) Conforming amendment.--Section 175(a) of title 18, 
        United States Code, is amended in the second sentence by 
        striking ``under this section'' and inserting ``under this 
        subsection''.
    (b) Amendments to Antiterrorism and Effective Death Penalty Act of 
1996.--
            (1) Possession and use.--
                    (A) In general.--Section 511 of the Antiterrorism 
                and Effective Death Penalty Act of 1996 (Public Law 
                104-132) is amended--
                            (i) by striking subsection (f);
                            (ii) by redesignating subsection (g) as 
                        subsection (i); and
                            (iii) by inserting after subsection (e) the 
                        following subsection:
    ``(f) Possession and Use of Listed Biological Agents and Toxins.--
            ``(1) In general.--The Secretary shall by regulation 
        provide for the establishment and enforcement of standards and 
        procedures governing the possession and use of biological 
        agents and toxins listed pursuant to subsection (d)(1) in order 
        to protect the public health and safety, including safeguards 
        to prevent access to such agents and toxins for use in domestic 
        or international terrorism or for any other criminal purpose.
            ``(2) Registration.--Regulations under paragraph (1) shall 
        provide for registration requirements regarding the possession 
        and use of biological agents and toxins listed pursuant to 
        subsection (d)(1).''.
                    (B) Regulations.--
                            (i) Date certain for promulgation; 
                        effective date regarding criminal and civil 
                        penalties.--Not later than 30 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 511(f) of the Antiterrorism and 
                        Effective Death Penalty Act of 1996, as added 
                        by subparagraph (A) of this paragraph. Such 
                        interim final rule takes effect 60 days after 
                        the date on which such rule is promulgated, 
                        including for purposes of--
                                    (I) section 175(b)(2) of title 18, 
                                United States Code (relating to 
                                criminal penalties), as added by 
                                subsection (a)(1)(B) of this section; 
                                and
                                    (II) section 511(h) of the 
                                Antiterrorism and Effective Death 
                                Penalty Act of 1996 (relating to civil 
                                penalties), as added by paragraph (3) 
                                of this subsection.
                            (ii) Submission of registration 
                        applications.--In the case of a person who, as 
                        of the date of the enactment of this Act, is in 
                        possession of a biological agent or toxin that 
                        is listed pursuant to section 511(d)(1) of the 
                        Antiterrorism and Effective Death Penalty Act 
                        of 1996, such person shall, in accordance with 
                        the interim final rule promulgated under clause 
                        (i), submit an application for a registration 
                        to possess such agent or toxin not later than 
                        30 days after the date on which such rule is 
                        promulgated.
            (2) Disclosures of information.--
                    (A) In general.--Section 511 of the Antiterrorism 
                and Effective Death Penalty Act of 1996, as amended by 
                paragraph (1) of this subsection, is amended by 
                inserting after subsection (f) the following 
                subsection:
    ``(g) Disclosure of Information.--
            ``(1) In general.--Any information in the possession of any 
        Federal agency that identifies a person, or the geographic 
        location of a person, who is registered pursuant to regulations 
        under this section (including regulations promulgated before 
        the effective date of this subsection), and any site-specific 
        information relating to the type, quantity, or identity of a 
        biological agent or toxin listed pursuant to subsection (d)(1) 
        or the site-specific security mechanisms in place to protect 
        such agents and toxins, shall not be disclosed under section 
        552(a) of title 5, United States Code.
            ``(2) Disclosures for public health and safety; congress.--
        Nothing in this section may be construed as preventing the head 
        of any Federal agency--
                    ``(A) from making disclosures of information 
                described in paragraph (1) for purposes of protecting 
                the public health and safety; or
                    ``(B) from making disclosures of such information 
                to any committee or subcommittee of the Congress with 
                appropriate jurisdiction, upon request.''.
                    (B) Effective date.--The effective date for the 
                amendment made by subparagraph (A) shall be the same as 
                the effective date for the final rule issued pursuant 
                to section 511(d)(1) of the Antiterrorism and Effective 
                Death Penalty Act of 1996 (Public Law 104-132).
            (3) Civil penalties.--Section 511 of the Antiterrorism and 
        Effective Death Penalty Act of 1996, as amended by paragraphs 
        (1) and (2) of this subsection, is amended by inserting after 
        subsection (g) the following subsection:
    ``(h) Civil Penalty.--Any person who violates a regulation under 
subsection (e) or (f) shall be subject to the United States for a civil 
penalty in an amount not exceeding $250,000 in the case of an 
individual and $500,000 in the case of any other person.''.
            (4) Clarification of scope of select agent rule; terrorism; 
        responsibilities of secretary of health and human services.--
                    (A) In general.--Section 511 of the Antiterrorism 
                and Effective Death Penalty Act of 1996 (Public Law 
                104-132) is amended--
                            (i) in each of subsections (d) and (e)--
                                    (I) by inserting ``and toxins'' 
                                after ``agents'' each place such term 
                                appears; and
                                    (II) by inserting ``or toxin'' 
                                after ``agent'' each place such term 
                                appears; and
                            (ii) in subsection (i) (as redesignated by 
                        paragraph (1) of this subsection), in paragraph 
                        (1), by striking ``the term `biological agent' 
                        has'' and inserting ``the terms `biological 
                        agent' and `toxin' have''.
                    (B) Effective date.--The effective date for the 
                amendments made by subparagraph (A) shall be as if the 
                amendments had been included in the enactment of 
                section 511 of the Antiterrorism and Effective Death 
                Penalty Act of 1996 (Public Law 104-132).
            (5) Conforming amendments.--Section 511 of the 
        Antiterrorism and Effective Death Penalty Act of 1996 (Public 
        Law 104-132) is amended--
                    (A) in subsection (d)(1)(A), by striking ``shall, 
                through regulations promulgated under subsection (f),'' 
                and inserting ``shall by regulation'';
                    (B) in subsection (e), in the matter preceding 
                paragraph (1), by striking ``shall, through regulations 
                promulgated under subsection (f),'' and inserting 
                ``shall by regulation'';
                    (C) in subsection (d)--
                            (i) in the heading for the subsection, by 
                        striking ``Agents'' and inserting ``Agents and 
                        Toxins''; and
                            (ii) in the heading for paragraph (1), by 
                        striking ``agents'' and inserting ``agents and 
                        toxins''; and
                    (D) in the heading for subsection (e), by striking 
                ``Agents'' and inserting ``Agents and Toxins''.
    (c) 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 511 of the Antiterrorism and 
        Effective Death Penalty Act of 1996 (Public Law 104-132), 
        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 future plans of the Secretary for 
        determining compliance with regulations under such section 511 
        and for taking appropriate enforcement actions; and
            (3) provides any recommendations of the Secretary for 
        administrative or legislative initiatives regarding such 
        section 511.

            Passed the House of Representatives October 23, 2001.

            Attest:

                                                 JEFF TRANDAHL,

                                                                 Clerk.

Summary: Bioterrorism Prevention Act of 2001 - Amends the Federal criminal code to set penalties for: (1) possessing, using, or exercising control over a select agent (i. e. a biological agent or toxin that is listed and not exempt under the Antiterrorism and Effective Death Penalty Act of 1996 (AEDPA)) in a manner constituting reckless disregard for the public health and safety, knowing the agent to be a biological agent or toxin. (2) causing bodily injury to another in the course of a violation, (3) possessing such agents without registration. And (4) transferring such agents to an unregistered person. Prohibits restricted persons from possessing, or taking specified actions with respect to, select agents. Allows the Secretary of Health and Human Services to designate categories or individuals who may be admitted to the United States on non-immigrant visas to permit them to work with such agents. Amends the AEDPA to direct the Secretary to: (1) provide by regulation for the establishment and enforcement of standards and procedures governing the possession and use of biological agents and toxins in order to protect the public health and safety, including safeguards to prevent access to such agents and toxins for use in domestic or international terrorism or for other criminal purposes. And (2) promulgate an interim final rule. Prohibits the disclosure under the Freedom of Information Act of agency information that identifies a person, or the geographic location of a person, who is registered pursuant to such regulations, and any site-specific information relating to the type, quantity, or identity of a listed biological agent or toxin or the site-specific security mechanisms in place to protect such agents and toxins, except for disclosures for purposes of protecting public health and safety, or to congressional committees or subcommittees with appropriate jurisdiction upon request. Establishes civil penalties of up to $250,000 in the case of an individual and $500,000 in the case of entities for violation of AEDPA regulations regarding transfers of listed biological agents. Directs the Secretary to report to Congress on compliance with the existing and expanded regulatory regime for control of select agents, and to provide recommendations for administrative or legislative initiatives.