[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR73.5]

[Page 447-448]
 
                         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. 73.5  Overlap select agents and toxins.

    Except for exclusions under paragraph (f) of this section, the 
viruses, bacteria, fungi, toxins, genetic elements, recombinant nucleic 
acids, and recombinant organisms specified in paragraphs (a) through (e) 
of this part are overlap select agents and toxins.
    (a) Viruses:
    (1) Eastern Equine Encephalitis virus.
    (2) Nipah and Hendra Complex viruses.
    (3) Rift Valley fever virus.
    (4) Venezuelan Equine Encephalitis virus.
    (b) Bacteria:
    (1) Bacillus anthracis.
    (2) Brucella abortus.
    (3) Brucella melitensis.
    (4) Brucella suis.
    (5) Burkholderia mallei (formerly Pseudomonas mallei).
    (6) Burkholderia pseudomallei (formerly Pseudomonas pseudomallei).
    (7) Botulinum neurotoxin producing species of Clostridium.
    (8) Coxiella burnetii.
    (9) Francisella tularensis.
    (c) Fungi: Coccidioides immitis.
    (d) Toxins:
    (1) Botulinum neurotoxins.
    (2) Clostridium perfringens epsilon toxin.
    (3) Shigatoxin.
    (4) Staphylococcal enterotoxins.
    (5) T-2 toxin.
    (e) Genetic elements, recombinant nucleic acids, and recombinant 
organisms:
    (1) Select agent viral nucleic acids (synthetic or naturally 
derived, contiguous or fragmented, in host chromosomes or in expression 
vectors) that can encode infectious and/or replication competent forms 
of any of the select agent viruses.
    (2) Nucleic acids (synthetic or naturally derived) that encode for 
the functional form(s) of any of the toxins listed in paragraph (d) of 
this section if the nucleic acids:
    (i) Are in a vector or host chromosome;

[[Page 448]]

    (ii) Can be expressed in vivo or in vitro; or
    (iii) Are in a vector or host chromosome and can be expressed in 
vivo or in vitro.
    (3) Viruses, bacteria, fungi, and toxins listed in paragraphs (a) 
through (d) of this section that have been genetically modified.
    (f) Exclusions:
    (1) This section does not include any select agent or toxin that is 
in its naturally occurring environment provided that it has not been 
intentionally introduced, cultivated, collected, or otherwise extracted 
from its natural source.
    (2) This section does not include non-viable select agent organisms 
or nonfunctional toxins.
    (3) Paragraph (a) does not include the vaccine strain of Rift Valley 
fever virus (MP-12) or Venezuelan Equine encephalitis virus vaccine 
strain TC-83.
    (4) Paragraph (d) of this section does not include the following 
toxins (in the purified form or in combinations of pure and impure 
forms) if the aggregate amount under the control of a principal 
investigator does not, at any time, exceed the amount specified: 0.5 mg 
of Botulinum neurotoxins; 5 mg of Staphylococcal enterotoxins; 100 mg of 
Clostridium perfringens epsilon toxin; 100 mg of Shigatoxin; or 1,000 mg 
of T-2 toxin.
    (5) The HHS Secretary, after consultation with the USDA Secretary, 
may exclude from this section attenuated strains of overlap select 
agents or toxins upon a determination that they do not pose a severe 
threat to the public health and safety and do not meet the criteria in 9 
CFR part 121 for inclusion. To apply for an exclusion, an applicant must 
submit a request in writing in accordance with Sec. 73.21 to the HHS 
Secretary or the USDA Secretary in accordance with 9 CFR part 121, 
establishing that the attenuated strain is eligible for exclusion. In 
response to an application submitted to the HHS Secretary, the HHS 
Secretary will provide a written decision granting the request, in whole 
or in part, or denying the request. An exclusion will be effective upon 
notification to the applicant. Exclusions will be published in the 
notice section of the Federal Register and will be listed on the CDC Web 
site at http://www.cdc.gov. Also, they will be referenced in this 
section when changes are made based on periodic reviews.