[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: 42CFR73.4]



[Page 440-442]

 

                         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. 73.4  Overlap 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, to animal health, or to animal products.

    (b) Overlap select agents and toxins:



Bacillus anthracis

Botulinum neurotoxins

Botulinum neurotoxin producing species of Clostridium

Brucella abortus

Brucella melitensis

Brucella suis

Burkholderia mallei (formerly Pseudomonas mallei)

Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)

Clostridium perfringens epsilon toxin

Coccidioides immitis

Coxiella burnetii

Eastern Equine Encephalitis virus

Francisella tularensis

Hendra virus

Nipah virus

Rift Valley fever virus

Shigatoxin

Staphylococcal enterotoxins

T-2 toxin

Venezuelan Equine Encephalitis virus



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

Organisms:

    (1) Nucleic acids that can produce infectious forms of any of the 

overlap select agent viruses listed in paragraph (b) of this section.

    (2) Recombinant nucleic acids that encode for the functional form(s) 

of



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any overlap 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) 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 select agent or toxin has not 

been intentionally introduced, cultivated, collected, or otherwise 

extracted from its natural source.

    (2) Non-viable overlap select agents or nonfunctional overlap 

toxins.

    (3) Overlap 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: 0.5 mg of Botulinum neurotoxins; 100 mg of 

Clostridium perfringens epsilon toxin; 100 mg of Shigatoxin; 5 mg of 

Staphylococcal enterotoxins; or 1,000 mg of T-2 toxin.

    (e) An attenuated strain of an overlap 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, to animal health, or to animal products.

    (1) To apply for an 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 

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 

overlap 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 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 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 

overlap select agent or toxin to CDC or APHIS.

    (i) The seizure of Bacillus anthracis, Botulinum neurotoxins, 

Brucella melitensis, Francisella tularensis, Hendra virus, Nipah virus, 

Rift Valley fever virus, or Venezuelan equine encephalitis virus 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 overlap select agents or toxins, APHIS/CDC Form 4 

must be submitted within seven calendar days after seizure of the select 

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 overlap select agent or toxin by the submission of APHIS/CDC Form 

4. A



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copy of the completed form must be maintained for three years.