|
Viruses
| Crimean-Congo
haemorrhagic fever virus |
South American
Haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito) |
| Eastern Equine
Encephalitis virus |
Tick-borne encephalitis
complex viruses |
| Ebola viruses |
Variola major
virus (smallpox virus) |
| Equine Morbillvirus |
Venezuelan Equine
Encephalitis virus |
| Lassa fever virus |
Viruses causing
hantavirus pulmonary syndrome |
| Marburg virus |
Yellow fever virus |
| Rift Valley fever
virus |
|
Exemptions: Vaccine strains
of viral agents (Junin Virus strain candid #1, Rift Valley fever virus strain
MP-12, Venezuelan Equine encephalitis virus strain TC-83, Yellow fever virus
strain 17-D) are exempt.
Bacteria
| Bacillus anthracis |
Clostridium botulinum |
| Brucella abortus,
B. melitensis, B. suis |
Francisella tularensis |
| Burkholderia (Pseudomonas)
mallei |
Yersinia pestis |
| Burkholderia (Pseudomonas)
pseudomallei |
|
Exceptions:
Vaccine strains as described in Title 9 CFR, 78.1 are exempt.
Rickettsiae
| Coxiella burnetii |
Rickettsia rickettsii |
| Rickettsia prowazekii |
|
Fungi
Coccidioides immitis
Toxins
| Arbin |
Ricin |
| Aflatoxins |
Saxitoxin |
| Botulinum toxins |
Shigatoxin |
| Clostridium perfringens
epsilon toxin |
Staphylococcal
entertoxins |
| Conotoxins |
Tetrodotoxin |
| Diacetoxyscirpenol |
T-2 toxin |
Exemptions: Toxins for
medical use, inactivated for use as vaccines, or toxin preparations for
biomedical research use at an LD50for vertebrates of more than 100 nanograms
per kilogram body weight are exempt. National standard toxins required
for biologic testing as described in 9 CFR Part 113 are exempt.
Recombinant
Organisms/Molecules
Genetically modified microorganisms
or genetic elements from organisms on Appendix A, shown to produce or encode
for a factor associated with disease.
Genetically modified microorganisms
or genetic elements that contain nucleic acid sequences coding for any of
the toxins listed in this Appendix, or their toxic subunits.
Other
Restrictions
The
deliberate transfer of a drug resistance trait to microorganisms listed in
this Appendix that are not known to acquire the trait naturally is prohibited
by NIH “Guidelines for Research Involving Recombinant DNA Molecules,” if such
acquisition could compromise the use of the drug to control these disease
agents in humans or veterinary medicine.
Additional Exemptions
Products subject to regulation
under the Federal Insecticide Fungicide and Rodenticide Act (7 U.S.C 136
et seq.) and the Toxic Substances Control Act (15 U.S.C. 2601 et seq.) are
exempt.
Additional exemptions for otherwise
covered strains will be considered when CDC reviews and updates the list of
select agents in this Appendix. Individuals seeking an exemption should submit
a request to CDC that specifies the agent or strain to be exempted and explains
why such an exemption should be granted. Future exemptions will be published
in the Federal Register for review and comment prior to inclusion in this
Appendix. [61 FR 55199, Oct. 24,1996]
|
