<num style="-uslm-dtd:enum" value="II">TITLE II—</num><heading style="-uslm-dtd:header">ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS </heading> <elided style="-uslm-dtd:omitted-text">* * * * * * *</elided> <subtitle style="-uslm-dtd:subtitle; -uslm-dtd-nonstandard:cap-lc 10 no-bold" identifier="/us/sComp/107/188/tII/stB" styleType="nonstandard"> <num style="-uslm-dtd:enum" value="B">subtitle B—</num><heading style="-uslm-dtd:header">Department of Agriculture </heading> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tII/stB/s211" styleType="OLC"> <num style="-uslm-dtd:enum" value="211">SEC. 211. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8401">7 U.S.C. 8401 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">SHORT TITLE. </heading> <content style="-uslm-dtd:text" class="block">This subtitle may be cited as the “<shortTitle style="-uslm-dtd:quote"><inline style="-uslm-dtd:short-title">Agricultural Bioterrorism Protection Act of 2002</inline></shortTitle>”.</content> </section> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tII/stB/s212" styleType="OLC"> <num style="-uslm-dtd:enum" value="212">SEC. 212. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8401">7 U.S.C. 8401</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Regulatory Control of Certain Biological Agents and Toxins.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/a/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">List of biological agents and toxins.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/a/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Criteria.—</heading><chapeau style="-uslm-dtd:text">In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><chapeau style="-uslm-dtd:text">consider—</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">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;</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">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;</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/III" styleType="OLC"> <num style="-uslm-dtd:enum" value="III">(III) </num><content style="-uslm-dtd:text">the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; </content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/IV" styleType="OLC"> <num style="-uslm-dtd:enum" value="IV">(IV)</num><item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/IV/aa" styleType="OLC" class="inline"><num style="-uslm-dtd:enum" value="aa">(aa) </num><content style="-uslm-dtd:text">whether such inclusion would have a substantial negative impact on the research and development of solutions for the animal or plant disease caused by the agent or toxin; and</content></item> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/IV/bb" styleType="OLC" class="leftIndentDecrease1"> <num style="-uslm-dtd:enum" value="bb">(bb) </num><content style="-uslm-dtd:text">whether the negative impact described in item (aa) would substantially outweigh the risk posed by the agent or toxin to animal or plant health if it is not included on the list; and</content> </item> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/V" styleType="OLC"> <num style="-uslm-dtd:enum" value="V">(V) </num><content style="-uslm-dtd:text">any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products; and</content> </subclause> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups.</content> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/a/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Biennial review.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Regulation of Transfers of Listed Agents and Toxins.—</heading><chapeau style="-uslm-dtd:text">The Secretary shall by regulation provide for—</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/b/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/b/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">proper training and appropriate skills to handle such agents and toxins; and</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/b/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">proper laboratory facilities to contain and dispose of such agents and toxins;</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/b/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">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;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/b/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">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</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/b/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/c" styleType="OLC"> <num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Possession and Use of Listed Agents and Toxins.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/d" styleType="OLC"> <num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Registration; Identification; Database.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/d/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Registration.—</heading><content style="-uslm-dtd:text">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).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/d/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Identification; database.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/e" styleType="OLC"> <num style="-uslm-dtd:enum" value="e">(e) </num><heading style="-uslm-dtd:header">Safeguard and Security Requirements for Registered Persons.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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 collaboration with the Secretary of Homeland Security and the Attorney General, and shall ensure compliance with such requirements as part of the registration system under such regulations.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Limiting access to listed agents and toxins.—</heading><chapeau style="-uslm-dtd:text">Requirements under paragraph (1) shall include provisions to ensure that registered persons—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">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;</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">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</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C)</num><clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C/i" styleType="OLC" class="inline"><num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">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</content></clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C/ii" styleType="OLC" class="leftIndentDecrease1"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><chapeau style="-uslm-dtd:text">in the case of listed agents and toxins that are overlap agents—</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C/ii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">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</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C/ii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">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.</content> </subclause> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Submitted names; use of databases by attorney general.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/3/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Certain individuals.—</heading><chapeau style="-uslm-dtd:text">For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">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</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><chapeau style="-uslm-dtd:text">the individual is reasonably suspected by any Federal law enforcement or intelligence agency of—</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/ii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">committing a crime set forth in section 2332b(g)(5) of title 18, United States Code;</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/ii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">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</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/ii/III" styleType="OLC"> <num style="-uslm-dtd:enum" value="III">(III) </num><content style="-uslm-dtd:text">being an agent of a foreign power (as defined in section 1801 of title 50, United States Code).</content> </subclause> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/3/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><heading style="-uslm-dtd:header">Notification by attorney general regarding submitted names.—</heading><content style="-uslm-dtd:text">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).</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><heading style="-uslm-dtd:header">Notifications by secretary.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><heading style="-uslm-dtd:header">Expedited review.—</heading><chapeau style="-uslm-dtd:text">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—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/5/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">request the Attorney General to expedite the process of identification under paragraph (3)(A) and notification of the Secretary under paragraph (3)(C); and</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/5/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">expedite the notification of the registered person by the Secretary under paragraph (4).</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/6" styleType="OLC"> <num style="-uslm-dtd:enum" value="6">(6) </num><heading style="-uslm-dtd:header">Process regarding persons seeking to register.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/6/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">Individuals.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/6/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Other persons.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/7" styleType="OLC"> <num style="-uslm-dtd:enum" value="7">(7) </num><heading style="-uslm-dtd:header">Review.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">Administrative review.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">In general.—</heading><chapeau style="-uslm-dtd:text">Regulations under subsections (b) and (c) shall provide for an opportunity for a review by the Secretary—</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/i/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">when requested by the individual involved, of a determination under paragraph (2) to deny the individual access to listed agents and toxins; and</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/i/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">when requested by the person involved, of a determination under under paragraph (6) to deny or revoke registration for such person.</content> </subclause> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Ex parte review.—</heading><content style="-uslm-dtd:text">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.</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/iii" styleType="OLC"> <num style="-uslm-dtd:enum" value="iii">(iii) </num><heading style="-uslm-dtd:header">Final agency action.—</heading><content style="-uslm-dtd:text">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.</content> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/7/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Certain procedures.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">Submission of ex parte materials in judicial proceedings.—</heading><content style="-uslm-dtd:text">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).</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Disclosure of information.—</heading><content style="-uslm-dtd:text">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.</content> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/8" styleType="OLC"> <num style="-uslm-dtd:enum" value="8">(8) </num><heading style="-uslm-dtd:header">Notifications regarding theft or loss of agents.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/9" styleType="OLC"> <num style="-uslm-dtd:enum" value="9">(9) </num><heading style="-uslm-dtd:header">Technical assistance for registered persons.—</heading><content style="-uslm-dtd:text">The Secretary, in consultation with the Attorney General, may provide technical assistance to registered persons to improve security of the facilities of such persons.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/f" styleType="OLC"> <num style="-uslm-dtd:enum" value="f">(f) </num><heading style="-uslm-dtd:header">Inspections.—</heading><content style="-uslm-dtd:text">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).</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/g" styleType="OLC"> <num style="-uslm-dtd:enum" value="g">(g) </num><heading style="-uslm-dtd:header">Exemptions.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Overlap agents and toxins.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">In general.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">Limitation.—</heading><content style="-uslm-dtd:text">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.</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Definitions.—</heading><chapeau style="-uslm-dtd:text">For purposes of this section:</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><chapeau style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">overlap agents and toxins</term>” means biological agents and toxins that—</chapeau> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/I/aa" styleType="OLC"> <num style="-uslm-dtd:enum" value="aa">(aa) </num><content style="-uslm-dtd:text">are listed pursuant to subsection (a)(1); and</content> </item> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/I/bb" styleType="OLC"> <num style="-uslm-dtd:enum" value="bb">(bb) </num><content style="-uslm-dtd:text">are listed pursuant to section 315A(a)(1) of the Public Health Service Act.</content> </item> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><chapeau style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">overlap agent or toxin</term>” means a biological agent or toxin that—</chapeau> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/II/aa" styleType="OLC"> <num style="-uslm-dtd:enum" value="aa">(aa) </num><content style="-uslm-dtd:text">is listed pursuant to subsection (a)(1); and</content> </item> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/II/bb" styleType="OLC"> <num style="-uslm-dtd:enum" value="bb">(bb) </num><content style="-uslm-dtd:text">is listed pursuant to section 315A(a)(1) of the Public Health Service Act.</content> </item> </subclause> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Clinical or diagnostic laboratories.—</heading><chapeau style="-uslm-dtd:text">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—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">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</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.</content> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><heading style="-uslm-dtd:header">Products.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Relevant laws.—</heading><chapeau style="-uslm-dtd:text">For purposes of clause (i), the Acts specified in this clause are the following:</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">The Federal Food, Drug, and Cosmetic Act.</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">Section 351 of the Public Health Service Act.</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii/III" styleType="OLC"> <num style="-uslm-dtd:enum" value="III">(III) </num><content style="-uslm-dtd:text">The Act commonly known as the Virus-Serum-Toxin Act (the eighth paragraph under the heading “<quotedText style="-uslm-dtd:quote">Bureau of Animal Industry</quotedText>” in the Act of March 4, 1913; 21 U.S.C. 151–159).</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii/IV" styleType="OLC"> <num style="-uslm-dtd:enum" value="IV">(IV) </num><content style="-uslm-dtd:text">The Federal Insecticide, Fungicide, and Rodenticide Act.</content> </subclause> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii" styleType="OLC"> <num style="-uslm-dtd:enum" value="iii">(iii) </num><heading style="-uslm-dtd:header">Investigational use.—</heading> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><heading style="-uslm-dtd:header">Certain processes.—</heading><chapeau style="-uslm-dtd:text">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:</chapeau> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii/II/aa" styleType="OLC"> <num style="-uslm-dtd:enum" value="aa">(aa) </num><content style="-uslm-dtd:text">The person has submitted to the Secretary an application for the exemption meeting the requirements established by the Secretary.</content> </item> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii/II/bb" styleType="OLC"> <num style="-uslm-dtd:enum" value="bb">(bb) </num><content style="-uslm-dtd:text">The person has notified the Secretary that the investigation has been authorized under such an Act.</content> </item> </subclause> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><heading style="-uslm-dtd:header">Agricultural emergencies.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/E" styleType="OLC"> <num style="-uslm-dtd:enum" value="E">(E) </num><heading style="-uslm-dtd:header">Public health emergencies.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/g/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">General authority for exemptions not involving overlap agents or toxins.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/h" styleType="OLC"> <num style="-uslm-dtd:enum" value="h">(h) </num><heading style="-uslm-dtd:header">Disclosure of Information.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Nondisclosure of certain information.—</heading><chapeau style="-uslm-dtd:text">No Federal agency specified in paragraph (2) shall disclose under section 552 of title 5, United States Code, any of the following:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/E" styleType="OLC"> <num style="-uslm-dtd:enum" value="E">(E) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Covered agencies.—</heading><chapeau style="-uslm-dtd:text">For purposes of paragraph (1) only, the Federal agencies specified in this paragraph are the following:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">The Department of Health and Human Services, the Department of Justice, the Department of Agriculture, and the Department of Transportation.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">Any Federal agency to which information specified in paragraph (1) is transferred by any agency specified in subparagraph (A) of this paragraph.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">Any Federal agency that is a registered person, or has a sub-agency component that is a registered person.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Other exemptions.—</heading><content style="-uslm-dtd:text">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).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><heading style="-uslm-dtd:header">Rule of construction.—</heading><chapeau style="-uslm-dtd:text">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—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">listed agents and toxins, or individuals seeking access to such agents and toxins;</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">registered persons, or persons seeking to register their possession, use, or transfer of such agents and toxins;</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">general safeguard and security policies and requirements under regulations under subsections (b) and (c); or</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><heading style="-uslm-dtd:header">Disclosures to congress; other disclosures.—</heading><chapeau style="-uslm-dtd:text">This subsection may not be construed as providing any authority—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/5/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">to withhold information from the Congress or any committee or subcommittee thereof; or</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/5/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">to withhold information from any person under any other Federal law or treaty.</content> </subparagraph> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">Civil Money Penalty.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/i/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/i/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Applicability of certain provisions.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/j" styleType="OLC"> <num style="-uslm-dtd:enum" value="j">(j) </num><heading style="-uslm-dtd:header">Notification in Event of Release.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/k" styleType="OLC"> <num style="-uslm-dtd:enum" value="k">(k) </num><heading style="-uslm-dtd:header">Reports.—</heading><content style="-uslm-dtd:text">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).</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/l" styleType="OLC"> <num style="-uslm-dtd:enum" value="l">(l) </num><heading style="-uslm-dtd:header">Definitions.—</heading><chapeau style="-uslm-dtd:text">For purposes of this section:</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">The terms “<term style="-uslm-dtd:term">biological agent</term>” and “<quotedText style="-uslm-dtd:quote">toxin</quotedText>” have the meanings given such terms in section 178 of title 18, United States Code.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">listed agents and toxins</term>” means biological agents and toxins listed pursuant to subsection (a)(1).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">listed agents or toxins</term>” means biological agents or toxins listed pursuant to subsection (a)(1).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">The terms “<term style="-uslm-dtd:term">overlap agents and toxins</term>” and “<quotedText style="-uslm-dtd:quote">overlap agent or toxin</quotedText>” have the meaning given such terms in subsection (g)(1)(A)(ii).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">person</term>” includes Federal, State, and local governmental entities.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/6" styleType="OLC"> <num style="-uslm-dtd:enum" value="6">(6) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">registered person</term>” means a person registered under regulations under subsection (b) or (c).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/7" styleType="OLC"> <num style="-uslm-dtd:enum" value="7">(7) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">Secretary</term>” means the Secretary of Agriculture.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/m" styleType="OLC"> <num style="-uslm-dtd:enum" value="m">(m) </num><heading style="-uslm-dtd:header">Authorization of Appropriations.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> </section> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tII/stB/s213" styleType="OLC"> <num style="-uslm-dtd:enum" value="213">SEC. 213. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8401">7 U.S.C. 8401 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s213/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Date Certain for Promulgation of List.—</heading><content style="-uslm-dtd:text">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 “<quotedText style="-uslm-dtd:quote">Secretary</quotedText>”) 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.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s213/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Date Certain for Notice of Possession.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s213/c" styleType="OLC"> <num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Date Certain for Promulgation; Effective Date Regarding Criminal and Civil Penalties.—</heading><chapeau style="-uslm-dtd:text">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—</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s213/c/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">section 175b(c) of title 18, United States Code (relating to criminal penalties), as added by section 231(a)(5) of this Act; and</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s213/c/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">section 212(i) of this Act (relating to civil penalties).</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s213/d" styleType="OLC"> <num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Transitional Provision Regarding Current Research and Education.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> </section> </subtitle> <subtitle style="-uslm-dtd:subtitle" identifier="/us/sComp/107/188/tII/stC" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">Subtitle C—</num><heading style="-uslm-dtd:header">Interagency Coordination Regarding Overlap Agents and Toxins </heading> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tII/stC/s221" styleType="OLC"> <num style="-uslm-dtd:enum" value="221">SEC. 221. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8411">7 U.S.C. 8411</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">INTERAGENCY COORDINATION. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stC/s221/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/a/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Coordination.—</heading><content style="-uslm-dtd:text">The Secretary of Agriculture and the Secretary of Health and Human Services shall in accordance with this section coordinate activities regarding overlap agents and toxins.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/a/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Overlap agents and toxins; other terms.—</heading><chapeau style="-uslm-dtd:text">For purposes of this section:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/a/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">overlap agent or toxin</term>” means a biological agent or toxin that—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stC/s221/a/2/A/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">is listed pursuant to section 315A(a)(1) of the Public Health Service Act, as added by section 201 of this Act; and</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stC/s221/a/2/A/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">is listed pursuant to section 212(a)(1) of this Act.</content> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/a/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">section 351A program</term>” means the program under section 351A of the Public Health Service Act.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/a/2/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">section 212 program</term>” means the program under section 212 of this Act.</content> </subparagraph> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stC/s221/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Certain Matters.—</heading><chapeau style="-uslm-dtd:text">In carrying out the section 351A program and the section 212 program, the Secretary of Health and Human Services and the Secretary of Agriculture shall, to the greatest extent practicable, coordinate activities to achieve the following purposes:</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/b/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">To minimize any conflicts between the regulations issued under, and activities carried out under, such programs.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/b/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">To minimize the administrative burden on persons subject to regulation under both of such programs.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/b/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">To ensure the appropriate availability of biological agents and toxins for legitimate biomedical, agricultural or veterinary research, education, or other such purposes.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/b/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">To ensure that registration information for overlap agents and toxins under the section 351A and section 212 programs is contained in both the national database under the section 351A program and the national database under the section 212 program.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stC/s221/c" styleType="OLC"> <num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Memorandum of Understanding.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">Promptly after the date of the enactment of this Act, the Secretary of Agriculture and the Secretary of Health and Human Services shall enter into a memorandum of understanding regarding overlap agents and toxins that is in accordance with paragraphs (2) through (4) and contains such additional provisions as the Secretary of Agriculture and the Secretary of Health and Human Services determine to be appropriate.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Single registration system regarding registered persons.—</heading><chapeau style="-uslm-dtd:text">The memorandum of understanding under paragraph (1) shall provide for the development and implementation of a single system of registration for persons who possess, use, or transfer overlap agents or toxins and are required to register under both the section 351A program and the section 212 program. For purposes of such system, the memorandum shall provide for the development and implementation of the following:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">A single registration form through which the person submitting the form provides all information that is required for registration under the section 351A program and all information that is required for registration under the section 212 program.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">A procedure through which a person may choose to submit the single registration form to the agency administering the section 351A program (in the manner provided under such program), or to the agency administering the section 212 program (in the manner provided under such program).</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">A procedure through which a copy of a single registration form received pursuant to subparagraph (B) by the agency administering one of such programs is promptly provided to the agency administering the other program.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">A procedure through which the agency receiving the single registration form under one of such programs obtains the concurrence of the agency administering the other program that the requirements for registration under the other program have been met.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/E" styleType="OLC"> <num style="-uslm-dtd:enum" value="E">(E) </num><chapeau style="-uslm-dtd:text">A procedure through which—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stC/s221/c/2/E/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">the agency receiving the single registration form under one of such programs informs the agency administering the other program whether the receiving agency has denied the registration; and</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stC/s221/c/2/E/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">each of such agencies ensures that registrations are entered into the national database of registered persons that is maintained by each such agency.</content> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Process of identification.—</heading><chapeau style="-uslm-dtd:text">With respect to the process of identification under the section 351A program and the section 212 program for names and other identifying information submitted to the Attorney General (relating to certain categories of individuals and entities), the memorandum of understanding under paragraph (1) shall provide for the development and implementation of the following:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/3/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">A procedure through which a person who is required to submit information pursuant to such process makes (in addition to the submission to the Attorney General) a submission, at the option of the person, to either the agency administering the section 351A program or the agency administering the section 212 program, but not both, which submission satisfies the requirement of submission for both of such programs.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/3/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">A procedure for the sharing by both of such agencies of information received from the Attorney General by one of such agencies pursuant to the submission under subparagraph (A).</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/3/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">A procedure through which the agencies administering such programs concur in determinations that access to overlap agents and toxins will be granted.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><heading style="-uslm-dtd:header">Coordination of inspections and enforcement.—</heading><content style="-uslm-dtd:text">The memorandum of understanding under paragraph (1) shall provide for the development and implementation of procedures under which Federal personnel under the section 351A program and the section 212 program may share responsibilities for inspections and enforcement activities under such programs regarding overlap agents and toxins. Activities carried out under such procedures by one of such programs on behalf of the other may be carried out with or without reimbursement by the agency that administers the other program.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><heading style="-uslm-dtd:header">Date certain for implementation.—</heading><content style="-uslm-dtd:text">The memorandum of understanding under paragraph (1) shall be implemented not later than 180 days after the date of the enactment of this Act. Until the single system of registration under paragraph (2) is implemented, persons who possess, use, or transfer overlap agents or toxins shall register under both the section 351A program and the section 212 program.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stC/s221/d" styleType="OLC"> <num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Joint Regulations.—</heading><content style="-uslm-dtd:text">Not later than 18 months after the date on which the single system of registration under subsection (c)(2) is implemented, the Secretary of Health and Human Services and the Secretary of Agriculture shall jointly issue regulations for the possession, use, and transfer of overlap agents and toxins that meet the requirements of both the section 351A program and the section 212 program.</content> <elided style="-uslm-dtd:omitted-text">* * * * * * *</elided> </subsection> </section> </subtitle>

<num style="-uslm-dtd:enum" value="II">TITLE II—</num><heading style="-uslm-dtd:header">ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS </heading> <elided style="-uslm-dtd:omitted-text">* * * * * * *</elided> <subtitle style="-uslm-dtd:subtitle; -uslm-dtd-nonstandard:cap-lc 10 no-bold" identifier="/us/sComp/107/188/tII/stB" styleType="nonstandard"> <num style="-uslm-dtd:enum" value="B">subtitle B—</num><heading style="-uslm-dtd:header">Department of Agriculture </heading> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tII/stB/s211" styleType="OLC"> <num style="-uslm-dtd:enum" value="211">SEC. 211. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8401">7 U.S.C. 8401 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">SHORT TITLE. </heading> <content style="-uslm-dtd:text" class="block">This subtitle may be cited as the “<shortTitle style="-uslm-dtd:quote"><inline style="-uslm-dtd:short-title">Agricultural Bioterrorism Protection Act of 2002</inline></shortTitle>”.</content> </section> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tII/stB/s212" styleType="OLC"> <num style="-uslm-dtd:enum" value="212">SEC. 212. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8401">7 U.S.C. 8401</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Regulatory Control of Certain Biological Agents and Toxins.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/a/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">List of biological agents and toxins.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/a/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Criteria.—</heading><chapeau style="-uslm-dtd:text">In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><chapeau style="-uslm-dtd:text">consider—</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">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;</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">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;</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/III" styleType="OLC"> <num style="-uslm-dtd:enum" value="III">(III) </num><content style="-uslm-dtd:text">the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; </content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/IV" styleType="OLC"> <num style="-uslm-dtd:enum" value="IV">(IV)</num><item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/IV/aa" styleType="OLC" class="inline"><num style="-uslm-dtd:enum" value="aa">(aa) </num><content style="-uslm-dtd:text">whether such inclusion would have a substantial negative impact on the research and development of solutions for the animal or plant disease caused by the agent or toxin; and</content></item> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/IV/bb" styleType="OLC" class="leftIndentDecrease1"> <num style="-uslm-dtd:enum" value="bb">(bb) </num><content style="-uslm-dtd:text">whether the negative impact described in item (aa) would substantially outweigh the risk posed by the agent or toxin to animal or plant health if it is not included on the list; and</content> </item> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/i/V" styleType="OLC"> <num style="-uslm-dtd:enum" value="V">(V) </num><content style="-uslm-dtd:text">any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products; and</content> </subclause> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/a/1/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups.</content> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/a/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Biennial review.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Regulation of Transfers of Listed Agents and Toxins.—</heading><chapeau style="-uslm-dtd:text">The Secretary shall by regulation provide for—</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/b/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><chapeau style="-uslm-dtd:text">the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/b/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">proper training and appropriate skills to handle such agents and toxins; and</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/b/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">proper laboratory facilities to contain and dispose of such agents and toxins;</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/b/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">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;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/b/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">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</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/b/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/c" styleType="OLC"> <num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Possession and Use of Listed Agents and Toxins.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/d" styleType="OLC"> <num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Registration; Identification; Database.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/d/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Registration.—</heading><content style="-uslm-dtd:text">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).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/d/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Identification; database.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/e" styleType="OLC"> <num style="-uslm-dtd:enum" value="e">(e) </num><heading style="-uslm-dtd:header">Safeguard and Security Requirements for Registered Persons.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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 collaboration with the Secretary of Homeland Security and the Attorney General, and shall ensure compliance with such requirements as part of the registration system under such regulations.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Limiting access to listed agents and toxins.—</heading><chapeau style="-uslm-dtd:text">Requirements under paragraph (1) shall include provisions to ensure that registered persons—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">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;</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">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</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C)</num><clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C/i" styleType="OLC" class="inline"><num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">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</content></clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C/ii" styleType="OLC" class="leftIndentDecrease1"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><chapeau style="-uslm-dtd:text">in the case of listed agents and toxins that are overlap agents—</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C/ii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">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</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/2/C/ii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">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.</content> </subclause> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Submitted names; use of databases by attorney general.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/3/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Certain individuals.—</heading><chapeau style="-uslm-dtd:text">For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">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</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><chapeau style="-uslm-dtd:text">the individual is reasonably suspected by any Federal law enforcement or intelligence agency of—</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/ii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">committing a crime set forth in section 2332b(g)(5) of title 18, United States Code;</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/ii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">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</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/3/B/ii/III" styleType="OLC"> <num style="-uslm-dtd:enum" value="III">(III) </num><content style="-uslm-dtd:text">being an agent of a foreign power (as defined in section 1801 of title 50, United States Code).</content> </subclause> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/3/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><heading style="-uslm-dtd:header">Notification by attorney general regarding submitted names.—</heading><content style="-uslm-dtd:text">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).</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><heading style="-uslm-dtd:header">Notifications by secretary.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><heading style="-uslm-dtd:header">Expedited review.—</heading><chapeau style="-uslm-dtd:text">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—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/5/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">request the Attorney General to expedite the process of identification under paragraph (3)(A) and notification of the Secretary under paragraph (3)(C); and</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/5/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">expedite the notification of the registered person by the Secretary under paragraph (4).</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/6" styleType="OLC"> <num style="-uslm-dtd:enum" value="6">(6) </num><heading style="-uslm-dtd:header">Process regarding persons seeking to register.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/6/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">Individuals.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/6/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Other persons.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/7" styleType="OLC"> <num style="-uslm-dtd:enum" value="7">(7) </num><heading style="-uslm-dtd:header">Review.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">Administrative review.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">In general.—</heading><chapeau style="-uslm-dtd:text">Regulations under subsections (b) and (c) shall provide for an opportunity for a review by the Secretary—</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/i/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">when requested by the individual involved, of a determination under paragraph (2) to deny the individual access to listed agents and toxins; and</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/i/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">when requested by the person involved, of a determination under under paragraph (6) to deny or revoke registration for such person.</content> </subclause> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Ex parte review.—</heading><content style="-uslm-dtd:text">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.</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/A/iii" styleType="OLC"> <num style="-uslm-dtd:enum" value="iii">(iii) </num><heading style="-uslm-dtd:header">Final agency action.—</heading><content style="-uslm-dtd:text">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.</content> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/e/7/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Certain procedures.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">Submission of ex parte materials in judicial proceedings.—</heading><content style="-uslm-dtd:text">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).</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/e/7/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Disclosure of information.—</heading><content style="-uslm-dtd:text">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.</content> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/8" styleType="OLC"> <num style="-uslm-dtd:enum" value="8">(8) </num><heading style="-uslm-dtd:header">Notifications regarding theft or loss of agents.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/e/9" styleType="OLC"> <num style="-uslm-dtd:enum" value="9">(9) </num><heading style="-uslm-dtd:header">Technical assistance for registered persons.—</heading><content style="-uslm-dtd:text">The Secretary, in consultation with the Attorney General, may provide technical assistance to registered persons to improve security of the facilities of such persons.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/f" styleType="OLC"> <num style="-uslm-dtd:enum" value="f">(f) </num><heading style="-uslm-dtd:header">Inspections.—</heading><content style="-uslm-dtd:text">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).</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/g" styleType="OLC"> <num style="-uslm-dtd:enum" value="g">(g) </num><heading style="-uslm-dtd:header">Exemptions.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Overlap agents and toxins.—</heading> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><heading style="-uslm-dtd:header">In general.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">Limitation.—</heading><content style="-uslm-dtd:text">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.</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Definitions.—</heading><chapeau style="-uslm-dtd:text">For purposes of this section:</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><chapeau style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">overlap agents and toxins</term>” means biological agents and toxins that—</chapeau> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/I/aa" styleType="OLC"> <num style="-uslm-dtd:enum" value="aa">(aa) </num><content style="-uslm-dtd:text">are listed pursuant to subsection (a)(1); and</content> </item> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/I/bb" styleType="OLC"> <num style="-uslm-dtd:enum" value="bb">(bb) </num><content style="-uslm-dtd:text">are listed pursuant to section 315A(a)(1) of the Public Health Service Act.</content> </item> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><chapeau style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">overlap agent or toxin</term>” means a biological agent or toxin that—</chapeau> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/II/aa" styleType="OLC"> <num style="-uslm-dtd:enum" value="aa">(aa) </num><content style="-uslm-dtd:text">is listed pursuant to subsection (a)(1); and</content> </item> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/A/ii/II/bb" styleType="OLC"> <num style="-uslm-dtd:enum" value="bb">(bb) </num><content style="-uslm-dtd:text">is listed pursuant to section 315A(a)(1) of the Public Health Service Act.</content> </item> </subclause> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><heading style="-uslm-dtd:header">Clinical or diagnostic laboratories.—</heading><chapeau style="-uslm-dtd:text">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—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">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</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.</content> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><heading style="-uslm-dtd:header">Products.—</heading> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><heading style="-uslm-dtd:header">Relevant laws.—</heading><chapeau style="-uslm-dtd:text">For purposes of clause (i), the Acts specified in this clause are the following:</chapeau> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><content style="-uslm-dtd:text">The Federal Food, Drug, and Cosmetic Act.</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><content style="-uslm-dtd:text">Section 351 of the Public Health Service Act.</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii/III" styleType="OLC"> <num style="-uslm-dtd:enum" value="III">(III) </num><content style="-uslm-dtd:text">The Act commonly known as the Virus-Serum-Toxin Act (the eighth paragraph under the heading “<quotedText style="-uslm-dtd:quote">Bureau of Animal Industry</quotedText>” in the Act of March 4, 1913; 21 U.S.C. 151–159).</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/ii/IV" styleType="OLC"> <num style="-uslm-dtd:enum" value="IV">(IV) </num><content style="-uslm-dtd:text">The Federal Insecticide, Fungicide, and Rodenticide Act.</content> </subclause> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii" styleType="OLC"> <num style="-uslm-dtd:enum" value="iii">(iii) </num><heading style="-uslm-dtd:header">Investigational use.—</heading> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii/I" styleType="OLC"> <num style="-uslm-dtd:enum" value="I">(I) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </subclause> <subclause style="-uslm-dtd:subclause" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii/II" styleType="OLC"> <num style="-uslm-dtd:enum" value="II">(II) </num><heading style="-uslm-dtd:header">Certain processes.—</heading><chapeau style="-uslm-dtd:text">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:</chapeau> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii/II/aa" styleType="OLC"> <num style="-uslm-dtd:enum" value="aa">(aa) </num><content style="-uslm-dtd:text">The person has submitted to the Secretary an application for the exemption meeting the requirements established by the Secretary.</content> </item> <item style="-uslm-dtd:item" identifier="/us/sComp/107/188/tII/stB/s212/g/1/C/iii/II/bb" styleType="OLC"> <num style="-uslm-dtd:enum" value="bb">(bb) </num><content style="-uslm-dtd:text">The person has notified the Secretary that the investigation has been authorized under such an Act.</content> </item> </subclause> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><heading style="-uslm-dtd:header">Agricultural emergencies.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/g/1/E" styleType="OLC"> <num style="-uslm-dtd:enum" value="E">(E) </num><heading style="-uslm-dtd:header">Public health emergencies.—</heading><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/g/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">General authority for exemptions not involving overlap agents or toxins.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/h" styleType="OLC"> <num style="-uslm-dtd:enum" value="h">(h) </num><heading style="-uslm-dtd:header">Disclosure of Information.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Nondisclosure of certain information.—</heading><chapeau style="-uslm-dtd:text">No Federal agency specified in paragraph (2) shall disclose under section 552 of title 5, United States Code, any of the following:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/1/E" styleType="OLC"> <num style="-uslm-dtd:enum" value="E">(E) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Covered agencies.—</heading><chapeau style="-uslm-dtd:text">For purposes of paragraph (1) only, the Federal agencies specified in this paragraph are the following:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">The Department of Health and Human Services, the Department of Justice, the Department of Agriculture, and the Department of Transportation.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">Any Federal agency to which information specified in paragraph (1) is transferred by any agency specified in subparagraph (A) of this paragraph.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">Any Federal agency that is a registered person, or has a sub-agency component that is a registered person.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/2/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Other exemptions.—</heading><content style="-uslm-dtd:text">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).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><heading style="-uslm-dtd:header">Rule of construction.—</heading><chapeau style="-uslm-dtd:text">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—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">listed agents and toxins, or individuals seeking access to such agents and toxins;</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">registered persons, or persons seeking to register their possession, use, or transfer of such agents and toxins;</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">general safeguard and security policies and requirements under regulations under subsections (b) and (c); or</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/4/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">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.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/h/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><heading style="-uslm-dtd:header">Disclosures to congress; other disclosures.—</heading><chapeau style="-uslm-dtd:text">This subsection may not be construed as providing any authority—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/5/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">to withhold information from the Congress or any committee or subcommittee thereof; or</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stB/s212/h/5/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">to withhold information from any person under any other Federal law or treaty.</content> </subparagraph> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><heading style="-uslm-dtd:header">Civil Money Penalty.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/i/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/i/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Applicability of certain provisions.—</heading><content style="-uslm-dtd:text">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.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/j" styleType="OLC"> <num style="-uslm-dtd:enum" value="j">(j) </num><heading style="-uslm-dtd:header">Notification in Event of Release.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/k" styleType="OLC"> <num style="-uslm-dtd:enum" value="k">(k) </num><heading style="-uslm-dtd:header">Reports.—</heading><content style="-uslm-dtd:text">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).</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/l" styleType="OLC"> <num style="-uslm-dtd:enum" value="l">(l) </num><heading style="-uslm-dtd:header">Definitions.—</heading><chapeau style="-uslm-dtd:text">For purposes of this section:</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">The terms “<term style="-uslm-dtd:term">biological agent</term>” and “<quotedText style="-uslm-dtd:quote">toxin</quotedText>” have the meanings given such terms in section 178 of title 18, United States Code.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">listed agents and toxins</term>” means biological agents and toxins listed pursuant to subsection (a)(1).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">listed agents or toxins</term>” means biological agents or toxins listed pursuant to subsection (a)(1).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">The terms “<term style="-uslm-dtd:term">overlap agents and toxins</term>” and “<quotedText style="-uslm-dtd:quote">overlap agent or toxin</quotedText>” have the meaning given such terms in subsection (g)(1)(A)(ii).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">person</term>” includes Federal, State, and local governmental entities.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/6" styleType="OLC"> <num style="-uslm-dtd:enum" value="6">(6) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">registered person</term>” means a person registered under regulations under subsection (b) or (c).</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s212/l/7" styleType="OLC"> <num style="-uslm-dtd:enum" value="7">(7) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">Secretary</term>” means the Secretary of Agriculture.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s212/m" styleType="OLC"> <num style="-uslm-dtd:enum" value="m">(m) </num><heading style="-uslm-dtd:header">Authorization of Appropriations.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> </section> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tII/stB/s213" styleType="OLC"> <num style="-uslm-dtd:enum" value="213">SEC. 213. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8401">7 U.S.C. 8401 note</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s213/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Date Certain for Promulgation of List.—</heading><content style="-uslm-dtd:text">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 “<quotedText style="-uslm-dtd:quote">Secretary</quotedText>”) 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.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s213/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Date Certain for Notice of Possession.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s213/c" styleType="OLC"> <num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Date Certain for Promulgation; Effective Date Regarding Criminal and Civil Penalties.—</heading><chapeau style="-uslm-dtd:text">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—</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s213/c/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">section 175b(c) of title 18, United States Code (relating to criminal penalties), as added by section 231(a)(5) of this Act; and</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stB/s213/c/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">section 212(i) of this Act (relating to civil penalties).</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stB/s213/d" styleType="OLC"> <num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Transitional Provision Regarding Current Research and Education.—</heading><content style="-uslm-dtd:text">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.</content> </subsection> </section> </subtitle> <subtitle style="-uslm-dtd:subtitle" identifier="/us/sComp/107/188/tII/stC" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">Subtitle C—</num><heading style="-uslm-dtd:header">Interagency Coordination Regarding Overlap Agents and Toxins </heading> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tII/stC/s221" styleType="OLC"> <num style="-uslm-dtd:enum" value="221">SEC. 221. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8411">7 U.S.C. 8411</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">INTERAGENCY COORDINATION. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stC/s221/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/a/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Coordination.—</heading><content style="-uslm-dtd:text">The Secretary of Agriculture and the Secretary of Health and Human Services shall in accordance with this section coordinate activities regarding overlap agents and toxins.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/a/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Overlap agents and toxins; other terms.—</heading><chapeau style="-uslm-dtd:text">For purposes of this section:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/a/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><chapeau style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">overlap agent or toxin</term>” means a biological agent or toxin that—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stC/s221/a/2/A/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">is listed pursuant to section 315A(a)(1) of the Public Health Service Act, as added by section 201 of this Act; and</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stC/s221/a/2/A/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">is listed pursuant to section 212(a)(1) of this Act.</content> </clause> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/a/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">section 351A program</term>” means the program under section 351A of the Public Health Service Act.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/a/2/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">The term “<term style="-uslm-dtd:term">section 212 program</term>” means the program under section 212 of this Act.</content> </subparagraph> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stC/s221/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Certain Matters.—</heading><chapeau style="-uslm-dtd:text">In carrying out the section 351A program and the section 212 program, the Secretary of Health and Human Services and the Secretary of Agriculture shall, to the greatest extent practicable, coordinate activities to achieve the following purposes:</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/b/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">To minimize any conflicts between the regulations issued under, and activities carried out under, such programs.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/b/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">To minimize the administrative burden on persons subject to regulation under both of such programs.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/b/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">To ensure the appropriate availability of biological agents and toxins for legitimate biomedical, agricultural or veterinary research, education, or other such purposes.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/b/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">To ensure that registration information for overlap agents and toxins under the section 351A and section 212 programs is contained in both the national database under the section 351A program and the national database under the section 212 program.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stC/s221/c" styleType="OLC"> <num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Memorandum of Understanding.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">Promptly after the date of the enactment of this Act, the Secretary of Agriculture and the Secretary of Health and Human Services shall enter into a memorandum of understanding regarding overlap agents and toxins that is in accordance with paragraphs (2) through (4) and contains such additional provisions as the Secretary of Agriculture and the Secretary of Health and Human Services determine to be appropriate.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Single registration system regarding registered persons.—</heading><chapeau style="-uslm-dtd:text">The memorandum of understanding under paragraph (1) shall provide for the development and implementation of a single system of registration for persons who possess, use, or transfer overlap agents or toxins and are required to register under both the section 351A program and the section 212 program. For purposes of such system, the memorandum shall provide for the development and implementation of the following:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">A single registration form through which the person submitting the form provides all information that is required for registration under the section 351A program and all information that is required for registration under the section 212 program.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">A procedure through which a person may choose to submit the single registration form to the agency administering the section 351A program (in the manner provided under such program), or to the agency administering the section 212 program (in the manner provided under such program).</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">A procedure through which a copy of a single registration form received pursuant to subparagraph (B) by the agency administering one of such programs is promptly provided to the agency administering the other program.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/D" styleType="OLC"> <num style="-uslm-dtd:enum" value="D">(D) </num><content style="-uslm-dtd:text">A procedure through which the agency receiving the single registration form under one of such programs obtains the concurrence of the agency administering the other program that the requirements for registration under the other program have been met.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/2/E" styleType="OLC"> <num style="-uslm-dtd:enum" value="E">(E) </num><chapeau style="-uslm-dtd:text">A procedure through which—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stC/s221/c/2/E/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">the agency receiving the single registration form under one of such programs informs the agency administering the other program whether the receiving agency has denied the registration; and</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tII/stC/s221/c/2/E/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">each of such agencies ensures that registrations are entered into the national database of registered persons that is maintained by each such agency.</content> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Process of identification.—</heading><chapeau style="-uslm-dtd:text">With respect to the process of identification under the section 351A program and the section 212 program for names and other identifying information submitted to the Attorney General (relating to certain categories of individuals and entities), the memorandum of understanding under paragraph (1) shall provide for the development and implementation of the following:</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/3/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">A procedure through which a person who is required to submit information pursuant to such process makes (in addition to the submission to the Attorney General) a submission, at the option of the person, to either the agency administering the section 351A program or the agency administering the section 212 program, but not both, which submission satisfies the requirement of submission for both of such programs.</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/3/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">A procedure for the sharing by both of such agencies of information received from the Attorney General by one of such agencies pursuant to the submission under subparagraph (A).</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tII/stC/s221/c/3/C" styleType="OLC"> <num style="-uslm-dtd:enum" value="C">(C) </num><content style="-uslm-dtd:text">A procedure through which the agencies administering such programs concur in determinations that access to overlap agents and toxins will be granted.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><heading style="-uslm-dtd:header">Coordination of inspections and enforcement.—</heading><content style="-uslm-dtd:text">The memorandum of understanding under paragraph (1) shall provide for the development and implementation of procedures under which Federal personnel under the section 351A program and the section 212 program may share responsibilities for inspections and enforcement activities under such programs regarding overlap agents and toxins. Activities carried out under such procedures by one of such programs on behalf of the other may be carried out with or without reimbursement by the agency that administers the other program.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tII/stC/s221/c/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><heading style="-uslm-dtd:header">Date certain for implementation.—</heading><content style="-uslm-dtd:text">The memorandum of understanding under paragraph (1) shall be implemented not later than 180 days after the date of the enactment of this Act. Until the single system of registration under paragraph (2) is implemented, persons who possess, use, or transfer overlap agents or toxins shall register under both the section 351A program and the section 212 program.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tII/stC/s221/d" styleType="OLC"> <num style="-uslm-dtd:enum" value="d">(d) </num><heading style="-uslm-dtd:header">Joint Regulations.—</heading><content style="-uslm-dtd:text">Not later than 18 months after the date on which the single system of registration under subsection (c)(2) is implemented, the Secretary of Health and Human Services and the Secretary of Agriculture shall jointly issue regulations for the possession, use, and transfer of overlap agents and toxins that meet the requirements of both the section 351A program and the section 212 program.</content> <elided style="-uslm-dtd:omitted-text">* * * * * * *</elided> </subsection> </section> </subtitle> <num style="-uslm-dtd:enum" value="III">TITLE III—</num><heading style="-uslm-dtd:header">ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS </heading> <subtitle style="-uslm-dtd:subtitle; -uslm-dtd-nonstandard:cap-lc 10 no-bold" identifier="/us/sComp/107/188/tIII/stA" styleType="nonstandard"> <num style="-uslm-dtd:enum" value="A">subtitle A—</num><heading style="-uslm-dtd:header">Protection of Food Supply </heading> <elided style="-uslm-dtd:omitted-text">* * * * * * *</elided> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tIII/stA/s313" styleType="OLC"> <num style="-uslm-dtd:enum" value="313">SEC. 313. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8319">7 U.S.C. 8319</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">SURVEILLANCE OF ZOONOTIC DISEASES. </heading> <content style="-uslm-dtd:text" class="block">The Secretary of Health and Human Services, through the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention, and the Secretary of Agriculture shall coordinate the surveillance of zoonotic diseases.</content> <elided style="-uslm-dtd:omitted-text">* * * * * * *</elided> </section> </subtitle> <subtitle style="-uslm-dtd:subtitle; -uslm-dtd-nonstandard:cap-lc 10 no-bold" identifier="/us/sComp/107/188/tIII/stC" styleType="nonstandard"> <num style="-uslm-dtd:enum" value="C">subtitle C—</num><heading style="-uslm-dtd:header">General Provisions Relating to Upgrade of Agricultural Security </heading> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tIII/stC/s331" styleType="OLC"> <num style="-uslm-dtd:enum" value="331">SEC. 331. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s8320">7 U.S.C. 8320</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION SERVICE ACTIVITIES. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s331/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><chapeau style="-uslm-dtd:text">The Secretary of Agriculture (referred to in this section as the “<quotedText style="-uslm-dtd:quote">Secretary</quotedText>”) may utilize existing authorities to give high priority to enhancing and expanding the capacity of the Animal and Plant Health Inspection Service to conduct activities to—</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s331/a/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">increase the inspection capacity of the Service at international points of origin;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s331/a/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">improve surveillance at ports of entry and customs;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s331/a/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">enhance methods of protecting against the introduction of plant and animal disease organisms by terrorists;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s331/a/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><chapeau style="-uslm-dtd:text">develop new and improve existing strategies and technologies for dealing with intentional outbreaks of plant and animal disease arising from acts of terrorism or from unintentional introduction, including—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tIII/stC/s331/a/4/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">establishing cooperative agreements among Veterinary Services of the Animal and Plant Health Inspection Service, State animal health commissions and regulatory agencies for livestock and poultry health, and private veterinary practitioners to enhance the preparedness and ability of Veterinary Services and the commissions and agencies to respond to outbreaks of such animal diseases; and</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tIII/stC/s331/a/4/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><chapeau style="-uslm-dtd:text">strengthening planning and coordination with State and local agencies, including—</chapeau> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tIII/stC/s331/a/4/B/i" styleType="OLC"> <num style="-uslm-dtd:enum" value="i">(i) </num><content style="-uslm-dtd:text">State animal health commissions and regulatory agencies for livestock and poultry health; and</content> </clause> <clause style="-uslm-dtd:clause" identifier="/us/sComp/107/188/tIII/stC/s331/a/4/B/ii" styleType="OLC"> <num style="-uslm-dtd:enum" value="ii">(ii) </num><content style="-uslm-dtd:text">State agriculture departments; and</content> </clause> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s331/a/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><content style="-uslm-dtd:text">otherwise improve the capacity of the Service to protect against the threat of bioterrorism.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s331/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Automated Recordkeeping System.—</heading><content style="-uslm-dtd:text">The Administrator of the Animal and Plant Health Inspection Service may implement a central automated recordkeeping system to provide for the reliable tracking of the status of animal and plant shipments, including those shipments on hold at ports of entry and customs. The Secretary shall ensure that such a system shall be fully accessible to or fully integrated with the Food Safety Inspection Service.</content> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s331/c" styleType="OLC"> <num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Authorization of Appropriations.—</heading><content style="-uslm-dtd:text">There is authorized to be appropriated to carry out this section, $30,000,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.</content> </subsection> </section> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tIII/stC/s332" styleType="OLC"> <num style="-uslm-dtd:enum" value="332">SEC. 332. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t21/s679c">21 U.S.C. 679c</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">EXPANSION OF FOOD SAFETY INSPECTION SERVICE ACTIVITIES. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s332/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><chapeau style="-uslm-dtd:text">The Secretary of Agriculture may utilize existing authorities to give high priority to enhancing and expanding the capacity of the Food Safety Inspection Service to conduct activities to—</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s332/a/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">enhance the ability of the Service to inspect and ensure the safety and wholesomeness of meat and poultry products;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s332/a/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">improve the capacity of the Service to inspect international meat and meat products, poultry and poultry products, and egg products at points of origin and at ports of entry;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s332/a/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">strengthen the ability of the Service to collaborate with relevant agencies within the Department of Agriculture and with other entities in the Federal Government, the States, and Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e))) through the sharing of information and technology; and</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s332/a/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">otherwise expand the capacity of the Service to protect against the threat of bioterrorism.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s332/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Authorization of Appropriations.—</heading><content style="-uslm-dtd:text">There is authorized to be appropriated to carry out this section, $15,000,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.</content> </subsection> </section> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tIII/stC/s333" styleType="OLC"> <num style="-uslm-dtd:enum" value="333">SEC. 333. </num><heading style="-uslm-dtd:header">BIOSECURITY UPGRADES AT THE DEPARTMENT OF AGRICULTURE. </heading> <content style="-uslm-dtd:text" class="block">There is authorized to be appropriated for fiscal year 2002, $180,000,000 for the purpose of enabling the Agricultural Research Service to conduct building upgrades to modernize existing facilities, of which (1) $100,000,000 shall be allocated for renovation, updating, and expansion of the Biosafety Level 3 laboratory and animal research facilities at the Plum Island Animal Disease Center (Greenport, New York), and of which (2) $80,000,000 shall be allocated for the Agricultural Research Service/Animal and Plant Health Inspection Service facility in Ames, Iowa. There are authorized to be appropriated such sums as may be necessary for fiscal years 2003 through 2006 for the purpose described in the preceding sentence, for the planning and design of an Agricultural Research Service biocontainment laboratory for poultry research in Athens, Georgia, and for the planning, updating, and renovation of the Arthropod-Borne Animal Disease Laboratory in Laramie, Wyoming.</content> </section> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tIII/stC/s334" styleType="OLC"> <num style="-uslm-dtd:enum" value="334">SEC. 334. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s3353">7 U.S.C. 3353</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">AGRICULTURAL BIOSECURITY. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s334/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">Security at Colleges and Universities.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s334/a/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">Grants.—</heading><content style="-uslm-dtd:text">The Secretary of Agriculture (referred to in this section as the “<quotedText style="-uslm-dtd:quote">Secretary</quotedText>”) may award grants to covered entities to review security standards and practices at their facilities in order to protect against bioterrorist attacks.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s334/a/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Covered entities.—</heading><chapeau style="-uslm-dtd:text">Covered entities under this subsection are colleges or universities that—</chapeau> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tIII/stC/s334/a/2/A" styleType="OLC"> <num style="-uslm-dtd:enum" value="A">(A) </num><content style="-uslm-dtd:text">are colleges or universities as defined in section 1404 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3103); and</content> </subparagraph> <subparagraph style="-uslm-dtd:subparagraph" identifier="/us/sComp/107/188/tIII/stC/s334/a/2/B" styleType="OLC"> <num style="-uslm-dtd:enum" value="B">(B) </num><content style="-uslm-dtd:text">have programs in food and agricultural sciences, as defined in such section.</content> </subparagraph> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s334/a/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Limitation.—</heading><content style="-uslm-dtd:text">Each individual covered entity may be awarded one grant under paragraph (1), the amount of which shall not exceed $50,000.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s334/a/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><heading style="-uslm-dtd:header">Contract authority.—</heading><content style="-uslm-dtd:text">Colleges and universities receiving grants under paragraph (1) may use such grants to enter into contracts with independent private organizations with established and demonstrated security expertise to conduct the security reviews specified in such paragraph.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s334/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Guidelines for Agricultural Biosecurity.—</heading> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s334/b/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><heading style="-uslm-dtd:header">In general.—</heading><content style="-uslm-dtd:text">The Secretary may award grants to associations of food producers or consortia of such associations for the development and implementation of educational programs to improve biosecurity on farms in order to ensure the security of farm facilities against potential bioterrorist attacks.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s334/b/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><heading style="-uslm-dtd:header">Limitation.—</heading><content style="-uslm-dtd:text">Each individual association eligible under paragraph (1) may be awarded one grant under such paragraph, the amount of which shall not exceed $100,000. Each consortium eligible under paragraph (1) may be awarded one grant under such paragraph, the amount of which shall not exceed $100,000 per association participating in the consortium.</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s334/b/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><heading style="-uslm-dtd:header">Contract authority.—</heading><content style="-uslm-dtd:text">Associations of food producers receiving grants under paragraph (1) may use such grants to enter into contracts with independent private organizations with established and demonstrated expertise in biosecurity to assist in the development and implementation of educational programs to improve biosecurity specified in such paragraph.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s334/c" styleType="OLC"> <num style="-uslm-dtd:enum" value="c">(c) </num><heading style="-uslm-dtd:header">Authorization of Appropriations.—</heading><content style="-uslm-dtd:text">There are authorized to be appropriated to carry out this section such sums as may be necessary for each fiscal year.</content> </subsection> </section> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tIII/stC/s335" styleType="OLC"> <num style="-uslm-dtd:enum" value="335">SEC. 335. </num><editorialNote style="-uslm-dtd:usc-reference" role="uscRef"><b>[</b><ref href="/us/usc/t7/s3354">7 U.S.C. 3354</ref><b>]</b> </editorialNote><heading style="-uslm-dtd:header">AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOPMENT. </heading> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s335/a" styleType="OLC"> <num style="-uslm-dtd:enum" value="a">(a) </num><heading style="-uslm-dtd:header">In General.—</heading><chapeau style="-uslm-dtd:text">The Secretary of Agriculture (referred to in this section as the “<quotedText style="-uslm-dtd:quote">Secretary</quotedText>”) may utilize existing research authorities and research programs to protect the food supply of the United States by conducting and supporting research activities to—</chapeau> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s335/a/1" styleType="OLC"> <num style="-uslm-dtd:enum" value="1">(1) </num><content style="-uslm-dtd:text">enhance the capability of the Secretary to respond in a timely manner to emerging or existing bioterrorist threats to the food and agricultural system of the United States;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s335/a/2" styleType="OLC"> <num style="-uslm-dtd:enum" value="2">(2) </num><content style="-uslm-dtd:text">develop new and continue partnerships with institutions of higher education and other institutions to help form stable, long-term programs to enhance the biosecurity and food safety of the United States, including the coordination of the development, implementation, and enhancement of diverse capabilities for addressing threats to the nation's agricultural economy and food supply, with special emphasis on planning, training, outreach, and research activities related to vulnerability analyses, incident response, detection, and prevention technologies;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s335/a/3" styleType="OLC"> <num style="-uslm-dtd:enum" value="3">(3) </num><content style="-uslm-dtd:text">strengthen coordination with the intelligence community to better identify research needs and evaluate materials or information acquired by the intelligence community relating to potential threats to United States agriculture;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s335/a/4" styleType="OLC"> <num style="-uslm-dtd:enum" value="4">(4) </num><content style="-uslm-dtd:text">expand the involvement of the Secretary with international organizations dealing with plant and animal disease control;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s335/a/5" styleType="OLC"> <num style="-uslm-dtd:enum" value="5">(5) </num><content style="-uslm-dtd:text">continue research to develop rapid detection field test kits to detect biological threats to plants and animals and to provide such test kits to State and local agencies preparing for or responding to bioterrorism;</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s335/a/6" styleType="OLC"> <num style="-uslm-dtd:enum" value="6">(6) </num><content style="-uslm-dtd:text">develop an agricultural bioterrorism early warning surveillance system through enhancing the capacity of and coordination between State veterinary diagnostic laboratories, Federal and State agricultural research facilities, and public health agencies; and</content> </paragraph> <paragraph style="-uslm-dtd:paragraph" identifier="/us/sComp/107/188/tIII/stC/s335/a/7" styleType="OLC"> <num style="-uslm-dtd:enum" value="7">(7) </num><content style="-uslm-dtd:text">otherwise improve the capacity of the Secretary to protect against the threat of bioterrorism.</content> </paragraph> </subsection> <subsection style="-uslm-dtd:subsection" identifier="/us/sComp/107/188/tIII/stC/s335/b" styleType="OLC"> <num style="-uslm-dtd:enum" value="b">(b) </num><heading style="-uslm-dtd:header">Authorization of Appropriations.—</heading><content style="-uslm-dtd:text">There is authorized to be appropriated to carry out this section, $190,000,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.</content> </subsection> </section> <section style="-uslm-dtd:section" identifier="/us/sComp/107/188/tIII/stC/s336" styleType="OLC"> <num style="-uslm-dtd:enum" value="336">SEC. 336. </num><heading style="-uslm-dtd:header">ANIMAL ENTERPRISE TERRORISM PENALTIES. </heading><editorialNote style="-uslm-dtd:legis-comment"><b>[</b>Omitted-Amendments<b>]</b> </editorialNote> </section> </subtitle>