[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR73.3]



[Page 439-440]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 73_SELECT AGENTS AND TOXINS--Table of Contents

 

Sec. 73.3  HHS select agents and toxins.



    (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.

    (b) HHS select agents and toxins:



Abrin

Cercopithecine herpesvirus 1 (Herpes B virus)

Coccidioides posadasii

Conotoxins

Crimean-Congo haemorrhagic fever virus

Diacetoxyscirpenol

Ebola viruses

Lassa fever virus

Marburg virus

Monkeypox virus

Ricin

Rickettsia prowazekii

Rickettsia rickettsii

Saxitoxin

Shiga-like ribosome inactivating proteins

South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, 

Flexal, Guanarito)

Tetrodotoxin

Tick-borne encephalitis complex (flavi) viruses (Central European Tick-

borne encephalitis, Far Eastern Tick-borne encephalitis [Russian Spring 

and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic 

Fever])

Variola major virus (Smallpox virus) and Variola minor virus (Alastrim)

Yersinia pestis



    (c) Genetic Elements, Recombinant Nucleic Acids, and Recombinant 

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 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) HHS toxins under the control of a principal investigator, 

treating physician or veterinarian, or commercial manufacturer or 

distributor, if the aggregate amount does not, at any time, exceed the 

following amounts: 100 mg of Abrin; 100 mg of Conotoxins; 1,000 mg of 

Diacetoxyscirpenol; 100 mg of Ricin; 100 mg of Saxitoxin; 100 mg of 

Shiga-like ribosome inactivating proteins; or 100 mg of Tetrodotoxin.

    (e) An attenuated strain of a HHS select agent or toxin may be 

excluded from the requirements of this part based upon a determination 

that the attenuated strain does not pose a severe threat to public 

health and safety.

    (1) To apply for an exclusion, an individual or entity must submit a 

written



[[Page 440]]



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 

published periodically in the notice section of the Federal Register and 

will be listed on the CDC Web site at http://www.cdc.gov/.

    (2) If an excluded attenuated strain is subjected to any 

manipulation that restores or enhances its virulence, the resulting 

select agent or toxin will be subject to the requirements of this part.

    (3) An individual or entity may make a written request to the HHS 

Secretary for reconsideration of a decision denying an exclusion 

application. The written request for reconsideration must state the 

facts and reasoning upon which the individual or entity relies to show 

the decision was incorrect. The HHS Secretary will grant or deny the 

request for reconsideration as promptly as circumstances allow and will 

state, in writing, the reasons for the decision.

    (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 Ebola viruses, Lassa fever virus, Marburg virus, 

South American Haemorrhagic Fever virus (Junin, Machupo, Sabia, Flexal, 

Guanarito), 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.