(a) Except for exclusions under paragraphs (d) and (e) of this section, the HHS Secretary 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. 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) HHS select agents and toxins: AbrinBotulinum neurotoxins*Botulinum neurotoxin producing species of Clostridium*Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)Coxiella burnetiiCrimean-Congo haemorrhagic fever virusDiacetoxyscirpenolEastern Equine Encephalitis virusEbola virus*Francisella tularensis*Lassa fever virusLujo virusMarburg virus*Monkeypox virusReconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments (Reconstructed 1918 Influenza virus)RicinRickettsia prowazekiiSARS-associated coronavirus (SARS-CoV)SaxitoxinSouth American Haemorrhagic Fever viruses:ChapareGuanaritoJuninMachupoSabiaStaphylococcal enterotoxins (subtypes A-E)T-2 toxinTetrodotoxinTick-borne encephalitis virusFar Eastern subtypeSiberian subtypeKyasanur Forest disease virusOmsk haemorrhagic fever virusVariola major virus (Smallpox virus) *Variola minor virus (Alastrim) *Yersinia pestis *
(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 select agent viruses listed in paragraph (b) of this section.
(2) Recombinant and/or Synthetic nucleic acids that encode for the functional form(s) of any of the toxins 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) HHS select agents and toxins listed in paragraph (b) of this section that have been genetically modified.
(d) HHS select agents or toxins that meet any of the following criteria are excluded from the requirements of this part:
(1) Any HHS select agent or toxin that is in its naturally occurring environment provided the select agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
(2) Non-viable HHS select agents or nonfunctional HHS toxins.
(3) Except as required in Sec. 73.16(l), the aggregate amount of the toxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not, at any time, exceed the following amounts: 100 mg of Abrin; 0.5 mg of Botulinum neurotoxins; 100 mg of Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7); 1,000 mg of Diacetoxyscirpenol; 100 mg of Ricin; 100 mg of Saxitoxin; 5 mg of Staphylococcal enterotoxins (subtypes A-E); 1,000 mg of T-2 toxin; or 100 mg of Tetrodotoxin.
(i) The amounts are transferred only after the transferor uses due diligence and documents that the recipient has a legitimate need (i.e., reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such toxins. Notwithstanding the provisions of paragraph (d) of this section, the HHS Secretary retains the authority to, without prior notification, inspect and copy or request the submission of the due diligence documentation to the CDC.
(ii) Reports to CDC if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to a toxin listed in this part.
(4) An animal inoculated with or exposed to an HHS select toxin.
(5) Any South American genotypes of Eastern Equine Encephalitis Virus and any West African Clade of Monkeypox virus provided that the individual or entity can identify that the agent is within the exclusion category.
(e) An attenuated strain of a select agent or a select toxin modified to be less potent or toxic may be excluded from the requirements of this part based upon a determination by the HHS Secretary that the attenuated strain or modified toxin does not pose a severe threat to public health and safety.
(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 modified 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 HHS 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 select 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 select 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 select agent or toxin against theft, loss, or release, and reports any theft, loss, or release of such agent or toxin, and
(3) The Federal law enforcement agency reports the seizure of the select agent or toxin to CDC or APHIS.
(i) The seizure of Botulinum neurotoxins, Botulinum neurotoxin producing species of Clostridium, Ebola viruses, Francisella tularensis, Marburg virus, Variola major virus (Smallpox virus), Variola minor (Alastrim), or Yersinia pestis must be reported within 24 hours by telephone, facsimile, or e-mail. This report must be followed by submission of APHIS/CDC Form 4 within seven calendar days after seizure of the select agent or toxin.
(ii) For all other HHS select agents or toxins, APHIS/CDC Form 4 must be submitted within seven calendar days after seizure of the agent or toxin.
(iii) A copy of APHIS/CDC Form 4 must be maintained for three years.
(4) The Federal law enforcement agency reports the final disposition of the select agent or toxin by submission of APHIS/CDC Form 4. A copy of the completed form must be maintained for three years. [70 FR 13316, Mar. 18, 2005, as amended at 70 FR 61049, Oct. 20, 2005; 73 FR 61365, Oct. 16, 2008; 73 FR 64554, Oct. 30, 2008; 77 FR 61110, Oct. 5, 2012; 79 FR 26861, May 12, 2014]