[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR72.7]

[Page 445-446]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 72_INTERSTATE SHIPMENT OF ETIOLOGIC AGENTS \1\--Table of Contents
 
Sec. 72.7  Penalties.

    Individuals in violation of this part are subject to a fine of no 
more than $250,000 or one year in jail, or both. Violations by 
organizations are subject to a fine or no more than $500,000 per event. 
A false, fictitious, or fraudulent statement or representation on the 
Government forms required in the part for registration of facilities or 
for transfers of select agents is subject to a fine or imprisonment for 
not more than five years, or both for an individual; and a fine for an 
organization.

[61 FR 55199, Oct. 24, 1996]

                  Appendix A to Part 72--Select Agents

                                 Viruses

1. Crimean-Congo haemorrhagic fever virus
2. Eastern Equine Encephalitis virus
3. Ebola viruses
4. Equine Morbillivirus
5. Lassa fever virus
6. Marburg virus
7. Rift Valley fever virus

[[Page 446]]

8. South American Haemorrhagic fever viruses (Junin, Machupo, Sabia, 
Flexal, Guanarito)
9. Tick-borne encephalitis complex viruses
10. Variola major virus (Smallpox virus)
11. Venezuelan Equine Encephalitis virus
12. Viruses causing hantavirus pulmonary syndrome
13. Yellow 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

1. Bacillus anthracis
2. Brucella abortus, B. melitensis, B. suis
3. Burkholderia (Pseudomonas) mallei
4. Burkholderia (Pseudomonas) pseudomallei
5. Clostridium botulinum
6. Francisella tularensis
7. Yersinia pestis
Exemptions: vaccine strains as described in Title 9 CFR, 78.1 are 
exempt.

                               Rickettsiae

1. Coxiella burnetii
2. Rickettsia prowazekii
3. Rickettsia rickettsii

                                  Fungi

1. Coccidioides immitis

                                 Toxins

1. Abrin
2. Aflatoxins
3. Botulinum toxins
4. Clostridium perfringens epsilon toxin
5. Conotoxins
6. Diacetoxyscirpenol
7. Ricin
8. Saxitoxin
9. Shigatoxin
10. Staphylococcal enterotoxins
11. Tetrodotoxin
12. T-2 toxin
Exemptions: Toxins for medical use, inactivated for use as vaccines, or 
toxin preparations for biomedical research use at an LD50 for 
vertebrates of more than 100 nanograms per kilogram body weight are 
exempt. National standard toxins required for biologic potency testing 
as described in 9 CFR Part 113 are exempt.

    Recombinant Organisms/Molecules
    1. Genetically modified microorganisms or genetic elements from 
organisms on Appendix A, shown to produce or encode for a factor 
associated with a disease.
    2. 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
    1. 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.
    2. 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]