Source: https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title7-chapter110&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGU3LXNlY3Rpb244NDAx%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim
Timestamp: 2020-01-27 16:00:18
Document Index: 501657093

Matched Legal Cases: ['§212', '§1709', '§12204', '§301', '§151', '§136', '§7701', '§211', '§211', '§213', '§8411', '§221']

[USC02] 7 USC Ch. 110: ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
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7 USC Ch. 110: ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
CHAPTER 110—ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall—
(III) the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin;
(IV)(aa) 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
(bb) 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
(V) any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products; and
The Secretary shall by regulation provide for—
(1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure—
Requirements under paragraph (1) shall include provisions to ensure that registered persons—
(ii) in the case of listed agents and toxins that are overlap agents—
For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that—
(ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of—
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—
Regulations under subsections (b) and (c) shall provide for an opportunity for a review by the Secretary—
(I) The term "overlap agents and toxins" means biological agents and toxins that—
(II) The term "overlap agent or toxin" means a biological agent or toxin that—
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—
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, or the obligation of any Federal agency to disclose under section 552 of title 5, any information, including information relating to—
This subsection may not be construed as providing any authority—
(Pub. L. 107–188, title II, §212, June 12, 2002, 116 Stat. 647; Pub. L. 107–296, title XVII, §1709(b), Nov. 25, 2002, 116 Stat. 2319; Pub. L. 115–334, title XII, §12204, Dec. 20, 2018, 132 Stat. 4949.)
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (g)(1)(C)(ii)(I), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
The Act commonly known as the Virus-Serum-Toxin Act, referred to in subsec. (g)(1)(C)(ii)(III), is the eighth paragraph under the heading "Bureau of Animal Industry" of act Mar. 4, 1913, ch. 145, 37 Stat. 832, as amended, which is classified generally to chapter 5 (§151 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Short Title note set out under section 151 of Title 21 and Tables.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsec. (g)(1)(C)(ii)(IV), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§136 et seq.) of chapter 6 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 136 of this title and Tables.
The Plant Protection Act, referred to in subsec. (i)(2), is title IV of Pub. L. 106–224, June 20, 2000, 114 Stat. 438, as amended, which is classified principally to chapter 104 (§7701 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 7701 of this title and Tables.
2018—Subsec. (a)(1)(B)(i)(IV), (V). Pub. L. 115–334 added subcl. (IV) and redesignated former subcl. (IV) as (V).
2002—Subsec. (e)(1). Pub. L. 107–296 substituted "collaboration with the Secretary of Homeland Security and" for "consultation with".
Pub. L. 107–188, title II, §211, June 12, 2002, 116 Stat. 647, provided that: "This subtitle [subtitle B (§§211–213) of title II of Pub. L. 107–188, enacting this subchapter] may be cited as the 'Agricultural Bioterrorism Protection Act of 2002'."
Pub. L. 107–188, title II, §213, June 12, 2002, 116 Stat. 656, provided that:
"(a) Date Certain for Promulgation of List.—Not later than 60 days after the date of the enactment of this Act [June 12, 2002], the Secretary of Agriculture (referred to in this section as the 'Secretary') shall promulgate an interim final rule that establishes the initial list under section 212(a)(1) [7 U.S.C. 8401(a)(1)]. In promulgating such rule, the Secretary shall provide written guidance on the manner in which the notice required in subsection (b) is to be provided to the Secretary.
"(b) Date Certain for Notice of Possession.—Not later than 60 days after the date on which the Secretary promulgates the interim final rule under subsection (a), all persons (unless exempt under section 212(g) [7 U.S.C. 8401(g)]) in possession of biological agents or toxins included on the list referred to in subsection (a) shall notify the Secretary of such possession.
"(c) Date Certain for Promulgation; Effective Date Regarding Criminal and Civil Penalties.—Not later than 180 days after the date of the enactment of this Act [June 12, 2002], the Secretary shall promulgate an interim final rule for carrying out section 212 [7 U.S.C. 8401], 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—
"(d) Transitional Provision Regarding Current Research and Education.—The interim final rule under subsection (c) shall include time frames for the applicability of the rule that minimize disruption of research or educational projects that involve biological agents and toxins listed pursuant to section 212(a)(1) [7 U.S.C. 8401(a)(1)] and that were underway as of the effective date of such rule."
§8411. Interagency coordination
The Secretary of Agriculture and the Secretary of Health and Human Services shall in accordance with this section coordinate activities regarding overlap agents and toxins.
(2) Overlap agents and toxins; other terms
(A) The term "overlap agent or toxin" means a biological agent or toxin that—
(i) is listed pursuant to section 315A(a)(1) 1 of the Public Health Service Act [42 U.S.C. 262a(a)(1)], as added by section 201 of this Act; and
(ii) is listed pursuant to section 212(a)(1) of this Act [7 U.S.C. 8401(a)(1)].
(B) The term "section 351A program" means the program under section 351A of the Public Health Service Act [42 U.S.C. 262a].
(C) The term "section 212 program" means the program under section 212 of this Act [7 U.S.C. 8401].
(b) Certain matters
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:
(1) To minimize any conflicts between the regulations issued under, and activities carried out under, such programs.
(2) To minimize the administrative burden on persons subject to regulation under both of such programs.
(3) To ensure the appropriate availability of biological agents and toxins for legitimate biomedical, agricultural or veterinary research, education, or other such purposes.
(4) 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.
Promptly after June 12, 2002, 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.
(2) Single registration system regarding registered persons
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:
(A) 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.
(B) 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).
(C) 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.
(D) 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.
(E) A procedure through which—
(i) 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
(ii) each of such agencies ensures that registrations are entered into the national database of registered persons that is maintained by each such agency.
(3) Process of identification
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:
(A) 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.
(B) 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).
(C) A procedure through which the agencies administering such programs concur in determinations that access to overlap agents and toxins will be granted.
(4) Coordination of inspections and enforcement
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.
(5) Date certain for implementation
The memorandum of understanding under paragraph (1) shall be implemented not later than 180 days after June 12, 2002. 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.
(d) Joint regulations
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.
(Pub. L. 107–188, title II, §221, June 12, 2002, 116 Stat. 657.)
1 So in original. Probably should be "351A(a)(1)".