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" (below).

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

Viruses
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.)

Bacteria
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.

Rickettsiae
Coxiella burnetti
Rickettsia prowazekii
Rickettsia rickettsii

Fungi
Coccidioides immitis

Toxins
Abrin
Aflatoxins
Botulinum toxins
Clostridium perfringens epsilon toxin
Conotoxins
Diacetoxyscirpenol
Ricin
Saxitoxin
Shigatoxin
Staphylococcal enterotoxins
Tetrodotoxin
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.


Almanac

Volume 43 Number 33
May 6, 1997


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