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SEC. 216. REGULATION OF 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-

(1) PUBLIC HEALTH SERVICE ACT- 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 BIOLOGICAL AGENTS AND TOXINS.

`(a) REGULATORY CONTROL OF 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 scientific experts representing appropriate professional groups, including those 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, through rulemaking, revise the list as necessary to incorporate additions or deletions to ensure public health, safety, and security .

`(3) EXEMPTIONS- The Secretary may exempt from the list under paragraph (1)--

`(A) attenuated or inactive biological agents or toxins used in biomedical research or for legitimate medical purposes; and

`(B) products that are cleared or approved under the Federal Food, Drug, and Cosmetic Act or under the Virus-Serum-Toxin Act, as amended in 1985 by the Food Safety and Security Act.';

`(b) REGULATION OF TRANSFERS OF LISTED BIOLOGICAL AGENTS AND TOXINS- The Secretary shall by regulation provide for--

`(1) the establishment and enforcement of safety procedures for the transfer of biological agents and toxins listed pursuant to subsection (a)(1), 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) safeguards 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 a biological agent or toxin in violation of the safety procedures established under paragraph (1) or the safeguards 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 BIOLOGICAL AGENTS AND TOXINS- 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 (a)(1) in order to protect the public health and safety, including the measures, safeguards, procedures, and availability of such agents and toxins described in paragraphs (1) through (4) of subsection (b), respectively.

`(d) REGISTRATION AND TRACEABILITY MECHANISMS- Regulations under subsections (b) and (c) shall require registration of the possession, use, and transfer of biological agents and toxins listed pursuant to subsection (a)(1), and such registration shall include (if available to the registered person) information regarding the characterization of such biological agents and toxins to facilitate their identification and traceability. The Secretary shall maintain a national database of the location of such biological agents and toxins with information regarding their characterizations.

`(e) INSPECTIONS- The Secretary shall have the authority to inspect persons subject to the regulations under subsections (b) and (c) to ensure their compliance with such regulations, including prohibitions on restricted persons under subsection (g).

`(f) EXEMPTIONS-

`(1) IN GENERAL- The Secretary shall establish exemptions, including exemptions from the security provisions for the use of attenuated or inactive biological agents or toxins in biomedical research or for legitimate medical purposes, from the applicability of provisions of--

`(A) the regulations issued under subsection (b) when the Secretary determines that the exemptions, including exemptions from the security requirements, are consistent with protecting public health and safety; and

`(B) the regulations issued under subsection (c) when the Secretary determines that the exemptions, including exemptions from the security requirements, are consistent with protecting public health and safety and that the agent or toxin does not present a threat of use in domestic or international terrorism .

`(2) CLINICAL LABORATORIES- The Secretary shall exempt clinical laboratories and other persons that possess, use, or transfer biological agents and toxins listed pursuant to subsection (a)(1) from the applicability of provisions of regulations issued under subsections (b) and (c) only when--

`(A) such agents or toxins are presented for diagnosis, verification, or proficiency testing;

`(B) the identification of such agents and toxins is, when required under Federal or State law, reported to the Secretary or other public health authorities; and

`(C) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary in regulation.

`(g) SECURITY REQUIREMENTS FOR REGISTERED PERSONS-

`(1) SECURITY - In carrying out paragraphs (2) and (3) of subsection (b), the Secretary shall establish appropriate security requirements for persons possessing, using, or transferring biological agents and toxins listed pursuant to subsection (a)(1), considering existing standards developed by the Attorney General for the security of government facilities, and shall ensure compliance with such requirements as a condition of registration under regulations issued under subsections (b), (c), and (d).

`(2) LIMITING ACCESS TO LISTED AGENTS AND TOXINS- Regulations issued under subsections (b) and (c) shall include provisions--

`(A) to restrict access to biological agents and toxins listed pursuant to subsection (a)(1) only to those individuals who need to handle or use such agents or toxins; and

`(B) to provide that registered persons promptly submit the names and other identifying information for such individuals to the Attorney General, with which information the Attorney General shall promptly use criminal, immigration, and national security databases available to the Federal Government to identify whether such individuals--

`(i) are restricted persons, as defined in section 175b of title 18, United States Code; or

`(ii) are named in a warrant issued to a Federal or State law enforcement agency for participation in any domestic or international act of terrorism .

`(3) CONSULTATION AND IMPLEMENTATION- Regulations under subsections (b) and (c) shall be developed in consultation with research-performing organizations, including universities, and implemented with timeframes that take into account the need to continue research and education using biological agents and toxins listed pursuant to subsection (a)(1).

`(h) 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), or any site-specific information relating to the type, quantity, or characterization of a biological agent or toxin listed pursuant to subsection (a)(1) or the site-specific security mechanisms in place to protect such agents and toxins, including the national database required in subsection (d), 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.

`(i) CIVIL PENALTY- In addition to any other penalties that may apply under law, any person who violates any provision of a regulation issued under subsection (b) or (c) 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.

`(j) DEFINITIONS- For purposes of this section, the terms `biological agent' and `toxin' have the same meaning as in section 178 of title 18, United States Code.'.

(2) REGULATIONS-

(A) DATE CERTAIN FOR PROMULGATION; EFFECTIVE DATE REGARDING CRIMINAL AND CIVIL PENALTIES- Not later than 180 days after the date of the enactment of this title, the Secretary of Health and Human Services shall promulgate an interim final rule for carrying out section 351A(c) of the Public Health Service Act, which amends the Antiterrorism and Effective Death Penalty Act of 1996. Such interim final rule will take effect 60 days after the date on which such rule is promulgated, including for purposes of--

(i) section 175(b) of title 18, United States Code (relating to criminal penalties), as added by subsection (b)(1)(B) of this section; and

(ii) section 351A(i) of the Public Health Service Act (relating to civil penalties).

(B) SUBMISSION OF REGISTRATION APPLICATIONS- A person required to register for possession under the interim final rule promulgated under subparagraph (A), shall submit an application for such registration not later than 60 days after the date on which such rule is promulgated.

(3) 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.

(4) EFFECTIVE DATE- Paragraph (1) shall take effect as if incorporated in the Antiterrorism and Effective Death Penalty Act of 1996, and any regulations, including the list under subsection (d)(1) of section 511 of that Act, issued under section 511 of that Act shall remain in effect as if issued under section 351A of the Public Health Service Act.

(b) SELECT AGENTS-

(1) IN GENERAL- Section 175 of title 18, United States Code, as amended by the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT ACT) Act of 2001 (Public Law 107-56) is amended--

(A) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and

(B) by inserting after subsection (a) the following:

`(b) SELECT AGENTS-

`(1) 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 required by regulation issued under section 351A(c) of the Public Health Service Act shall be fined under this title, or imprisoned for not more than 5 years, or both.

`(2) TRANSFER TO UNREGISTERED PERSON- Whoever transfers a select agent to a person who the transferor has reasons to believe has not obtained a registration required by regulations issued under section 351A(b) or (c) of the Public Health Service Act shall be fined under this title, or imprisoned for not more than 5 years, or both.'.

(2) DEFINITIONS- Section 175 of title 18, United States Code, as amended by paragraph (1), is further amended by striking subsection (d) and inserting the following:

`(d) 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 subsections (b) and (c), 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 `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.

`(3) The term `select agent' means a biological agent or toxin, as defined in paragraph (1), that 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), or as subsequently revised under section 351A(a) of the Public Health Service Act.'.

(3) CONFORMING AMENDMENT-

(A) 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) Section 175(c) of title 18, United States Code, (as redesignated by paragraph (1)), is amended by striking the second sentence.

(c) REPORT TO CONGRESS- Not later than 1 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, 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 section 351A(a)(1) of the Public Health Service Act;

(3) describes the actions to date and future plans of the Secretary for determining compliance with regulations under such section 351A of the Public Health Service Act and for taking appropriate enforcement actions; and

(4) provides any recommendations of the Secretary for administrative or legislative initiatives regarding such section 351A of the Public Health Service Act.

TITLE III--IMPROVING STATE AND LOCAL PREPAREDNESS

Subtitle A--Emergency Measures to Improve State and Local Preparedness

SEC. 301. STATE BIOTERRORISM PREPAREDNESS AND RESPONSE BLOCK GRANT.

(a) IN GENERAL- Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is amended by striking subsection (c) and inserting the following:

`(c) STATE BIOTERRORISM PREPAREDNESS AND RESPONSE BLOCK GRANTS-

`(1) IN GENERAL- The Secretary shall establish the State Bioterrorism Preparedness and Response Block Grant Program (referred to in this subsection as the `Program') under which the Secretary shall award grants to or enter into cooperative agreements with States, the District of Columbia, and territories (referred to in this section as `eligible entities') to enable such entities to prepare for and respond to biological threats or attacks. The Secretary shall ensure that activities conducted under this section are coordinated with the activities conducted under this section and section 319C.

`(2) ELIGIBILITY- To be eligible to receive amounts under paragraph (1), a State, the District of Columbia, or a territory shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including an assurance that the entity will--

`(A) not later than 180 days after the date on which a grant or contract is received under this subsection, prepare and submit to the Secretary a State Bioterrorism Preparedness and Response Plan in accordance with subsection (c);

`(B) not later than 180 days after the date on which a grant or contract is received under this subsection, complete an assessment under section 319B(a), or an assessment that is substantially equivalent as determined by the Secretary unless such assessment has already been performed; and

`(C) establish a means by which to obtain public comment and input on the plan and plan implementation that shall include an advisory committee or other similar mechanism for obtaining input from the public at large as well as other stakeholders;

`(D) use amounts received under paragraph (1) in accordance with the plan submitted under paragraph (3), including making expenditures to carry out the strategy contained in the plan;

`(E) use amounts received under paragraph (1) to supplement and not supplant funding at levels in existence prior to and on September 11, 2001 for public health capacities or bioterrorism preparedness; and

`(F) with respect to the plan under paragraph (3), establish reasonable criteria to evaluate the effective performance of entities that receive funds under the grant or agreement and shall include relevant benchmarks in the plan.

`(3) BIOTERRORISM PREPAREDNESS AND RESPONSE PLAN- Not later than 180 days after receiving amounts under this subsection, and 1 year after such date, a State, the District of Columbia, or a territory shall prepare and submit to the Secretary a Bioterrorism Preparedness and Response Plan for responding to biological threats or attacks. Recognizing the assessment of public health capacity conducted under section 319B, such plan shall include--

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