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7 U.S. Code § 8401. Regulation of certain biological agents and toxins
(a) Regulatory control of certain biological agents and toxins
(1) List of biological agents and toxins
(A) In general
The Secretary of Agriculture shall by regulation establish and maintain a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products.
(B) CriteriaIn determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall—
(i) consider—
(I)
the effect of exposure to the agent or toxin on animal or plant health, and on the production and marketability of animal or plant products;
(II)
the pathogenicity of the agent or the toxicity of the toxin and the methods by which the agent or toxin is transferred to animals or plants;
(III)
the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin;
(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
(ii)
consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups.
(2) Biennial review
The Secretary shall review and republish the list under paragraph (1) biennially, or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph.
(b) Regulation of transfers of listed agents and toxinsThe Secretary shall by regulation provide for—
(1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure—
(A)
proper training and appropriate skills to handle such agents and toxins; and
(B)
proper laboratory facilities to contain and dispose of such agents and toxins;
(2)
the establishment and enforcement of safeguard and security measures to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose;
(3)
the establishment of procedures to protect animal and plant health, and animal and plant products, in the event of a transfer or potential transfer of such an agent or toxin in violation of the safety procedures established under paragraph (1) or the safeguard and security measures established under paragraph (2); and
(4)
appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.