9 CFR 121.4 - Overlap select agents and toxins.

§ 121.4 Overlap select agents and toxins.
(a) Except as provided in paragraphs (d) and (e) of this section, the Administrator has determined that the biological agents and toxins listed in this section have the potential to pose a severe threat to public health and safety, to animal health, or to animal products. The select agents and toxins marked with an asterisk (*) are designated as Tier 1 select agents and toxins and are subject to additional requirements as listed in this part.
(b) Overlap select agents and toxins: *Bacillus anthracis; Bacillus anthracis (Pasteur strain); Brucella abortus; Brucella melitensis; Brucella suis; *Burkholderia mallei; *Burkholderia pseudomallei; Hendra virus; Nipah virus; Rift Valley fever virus; Venezuelan equine encephalitis virus.
(c) Genetic elements, recombinant and/or synthetic nucleic acids, and recombinant and/or synthetic organisms:
(1) Nucleic acids that can produce infectious forms of any of the overlap select agent viruses listed in paragraph (b) of this section. 4

Footnote(s):
4 The importation and interstate movement of overlap select agents or toxins listed in paragraphs (c)(1) through (c)(3) of this section may be subject to the permit requirements under part 122 of this subchapter.

(2) Recombinant and/or synthetic nucleic acids that encode for the functional forms of any overlap toxin listed in paragraph (b) of this section if the nucleic acids:
(i) Can be expressed in vivo or in vitro; or
(ii) Are in a vector or recombinant host genome and can be expressed in vivo or in vitro.
(3) Overlap select agents and toxins listed in paragraph (b) of this section that have been genetically modified.
(d) Overlap select agents or toxins that meet any of the following criteria are excluded from the requirements of this part:
(1) Any overlap select agent or toxin that is in its naturally occurring environment, provided that the agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(2) Nonviable overlap select agents or nonfunctional overlap toxins. 5

Footnote(s):
5 However, the importation and interstate movement of these nonviable overlap select agents may be subject to the permit requirements under part 122 of this subchapter.

(3) Any subtypes of Venezuelan equine encephalitis virus except for Subtypes IAB or IC, provided that the individual or entity can verify that the agent is within the exclusion category.
(e) An attenuated strain of a select agent or an inactive form of a select toxin may be excluded from the requirements of this part based upon a determination by the HHS Secretary or Administrator that the attenuated strain or inactivated toxin does not pose a severe threat to public health and safety, to animal health or to animal products.
(1) To apply for exclusion, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued. An exclusion will be effective upon notification to the applicant. Exclusions will be listed on the National Select Agent Registry Web site at http://www.selectagents.gov/ .
(2) If an excluded attenuated strain or inactivated toxin is subjected to any manipulation that restores or enhances its virulence or toxic activity, the resulting select agent or toxin will be subject to the requirements of this part.
(f) Any overlap select agent or toxin seized by a Federal law enforcement agency will be excluded from the requirements of this part during the period between seizure of the agent or toxin and the transfer or destruction of such agent or toxin provided that:
(1) As soon as practicable, the Federal law enforcement agency transfers the seized agent or toxin to an entity eligible to receive such agent or toxin or destroys the agent or toxin by a recognized sterilization or inactivation process.
(2) The Federal law enforcement agency safeguards and secures the seized agent or toxin against theft, loss, or release, and reports any theft, loss, or release of such agent or toxin.
(3) The Federal law enforcement agency reports the seizure of the overlap select agent or toxin to APHIS or CDC.
(i) The seizure of any of the following overlap select agents and toxins must be reported within 24 hours by telephone, facsimile, or e-mail: Bacillus anthracis, Burkholderia mallei, and Burkholderia pseudomallei. This report must be followed by submission of APHIS/CDC Form 4 within 7 calendar days after seizure of the overlap select agent or toxin.
(ii) For all other overlap select agents or toxins, APHIS/CDC Form 4 must be submitted within 7 calendar days after seizure of the agent or toxin.
(iii) A copy of APHIS/CDC Form 4 must be maintained for 3 years.
(4) The Federal law enforcement agency reports the final disposition of the overlap select agent or toxin by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for 3 years.
[70 FR 13284, Mar. 18, 2005, as amended at 73 FR 61331, Oct. 16, 2008; 77 FR 61078, Oct. 5, 2012]

Title 9 published on 2013-01-01

no entries appear in the Federal Register after this date.

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