New Federal Provisions to Regulate Hazardous Substances
The transfer of selected hazardous agents is now regulated by federal law. " The Antiterrorism and Effective Death Penalty Act of 1996" mandates
strict regulation of the use, transfer and disposal of "select agents"
As of April 15, 1997, commercial suppliers of "select agents" as well as government agencies, universities, research institutions, individuals and
private companies seeking to transfer or obtain the regulated "select agents" must register with the Centers for Disease Control and Prevention (CDC).
CDC is authorized to inspect facilities seeking registration to determine whether the applicant facility meets the established criteria. Facilities are
responsible to pay the CDC a site registration fee to cover costs related to administration of this program.
"Facility" is broadly defined in the regulation and includes universities and individuals. Facilities are broken down into three categories, small,
medium and large, depending upon the size of the facility, the number of personnel working in the facility and the amount of work done in the facility.
Facilities must pay site registration fees. Site registration fees for facilities registering
before March 31, 1998 are as follows:
Small facility $13,000
Medium facility $14,000
Large facility $15,000
Individuals in violation of the regulation will incur severe fines and criminal penalties of up to $250,00 or one year in jail, or both. Organizations
in violation will incur fines of up to $500,000 per event. A false, fraudulent or fictitious statement or representation on a Government registration form
is subject to a fine or imprisonment for up to five years or both for an individual; and a fine for an organization.
All registrations must be coordinated through the Office of Environmental Health and Radiation Safety (EHRS). All aplplications for registration
must be certified by the director of EHRS. Investigators are advised to contact the office at 898-4453 for the necessary form(s) and information.
List of Selected Agents
- Crimean-Congo haemorrhagic fever virus
- Eastern Equine Encephalitis virus
- Ebola viruses
- Equine Morbillivirus
- Lassa fever virus
- Marburg virus
- Rift Valley fever virus
- South American Haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
- Tick-borne encephalitis complex viruses
- Variola major virus (Smallpox virus)
- Venezuelan Equine Encephalitis virus
- Viruses causing hantavirus pulmonary syndrome
- Yellow fever virus
- Exceptions: 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.)
- Bacillus anthracis
- Brucella abortus, B. meletensis, B. suis
- Burkholderia (Pseudomonas) mallei
- Burkholderia (Pseudomonas) pseudomallei
- Clostridium botulinum
- Francisella tularensis
- Yersinia pestis
- Exceptions: Vaccine strains as described
in Title 9 CFR, Part 78.1 are exempt.
- Coxiella burnetti
- Rickettsia prowazekii
- Rickettsia rickettsii
- Coccidioides immitis
- Botulinum toxins
- Clostridium perfringens epsilon toxin
- Staphylococcal enterotoxins
- T-2 toxin
- Exemptions: Toxins for medical use, inactivated for use as vaccines or toxin preparations for biomedical research use at 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
- Genetically modified microorganisms or genetic
elements from the above organisms, 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 above, or their toxic subunits.
- Other Restrictions
- The deliberate transfer of a drug resistance trait to microorganisms listed above that are 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 and the Toxic Substances Control Act are exempt.
- Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents listed. 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 list.
Volume 43 Number 33
May 6, 1997
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