[Federal Register Volume 67, Number 164 (Friday, August 23, 2002)]
[Proposed Rules]
[Pages 54605-54607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21512]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 72, Appendix A
RIN 0920-AA08
Interstate Shipment of Etiologic Agents; Select Agents
AGENCY: Centers for Disease Control and Prevention, Department of
Health and Human Services.
ACTION: Notice of intent to issue regulations.
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SUMMARY: On June 12, 2002, President George W. Bush signed Public Law
107-188, Public Health Safety and Bioterrorism Preparedness and
Response Act of 2002. The Act specifies that the Secretary of the
Department of Health and Human Services establish and maintain a list
of biological agents and toxins that have the potential to pose a
severe threat to public health and safety. The Secretary directed the
Centers for Disease Control and Prevention (CDC) to convene an inter-
agency work group to review the current list of biological agents and
toxins found in 42 CFR part 72, Appendix A, and revise the list as
necessary.
Prior to issuing the Interim Final Rule, as required by Public Law
107-
[[Page 54606]]
188, the CDC is interested in obtaining public comments on the
revisions to 42 CFR part 72, Appendix A, that are under consideration.
In addition to these revisions, the CDC is particularly interested in
obtaining comments on whether there are biological agents and toxins
that should be added to the list or removed from the list.
DATES: Submit comments on or before September 17, 2002.
ADDRESSES: Comments on the revisions to the list of select agents and
toxins that are under consideration should be marked ``Comments on
Select Agents'' and mailed to: Centers for Disease Control and
Prevention, National Center for Infectious Diseases, Select Agent
Transfer Program, 1600 Clifton Road NE., Mailstop E-79, Atlanta,
Georgia 30333. Due to staff and equipment limitations, CDC cannot
accept comments by facsimile or electronic mail.
FOR FURTHER INFORMATION CONTACT: For information concerning the
revisions to the list of select agents and toxins that are under
consideration should contact: Ms. Jennifer Brooks, National Center for
Infectious Diseases, Office of the Director, 1600 Clifton Road NE.,
Mailstop C-12, Atlanta, Georgia 30333. Telephone: (404) 639-2763.
SUPPLEMENTARY INFORMATION:
Background
President George W. Bush signed the Public Health Safety and
Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188)
on June 12, 2002. The Act specifies that the Secretary of the
Department of Health and Human Services establish and maintain a list
of biological agents and toxins that have the potential to pose a
severe threat to public health and safety. The current list of select
agents and toxins was published in the Federal Register on October 24,
1996, and appears as Appendix A to 42 CFR part 72. This notice of
intent is part of the rule-making process that will culminate in the
publication of an Interim Final Rule. CDC anticipates publishing this
rule in coordination with the U.S. Department of Agriculture on or
before December 9, 2002.
The Secretary directed the Centers for Disease Control and
Prevention (CDC) to convene an inter-agency work group to review the
current list of biological agents and toxins and revise the list as
necessary. Members of the work group included representatives from the
Department of Health and Human Services/Office of the Secretary (DHHS/
OS), the Centers for Disease Control and Prevention (CDC), the National
Institutes of Health (NIH), the Food and Drug Administration (FDA), the
Department of the Army (DoD/Army), the Department of the Navy (DoD/
Navy), the Department of the Air Force (DoD/AF), the U.S. Department of
Agriculture (USDA), the Environmental Protection Agency (EPA), the
Agency for Toxic Substances and Disease Registry (ATSDR), the
Department of Labor/Occupational Safety and Health Administration
(OSHA), the National Institute of Occupational Safety and Health (CDC/
NIOSH), the Department of Transportation (DoT), the Department of
Commerce (DoC), Department of Energy (DoE), the Department of Justice
(DoJ), the Federal Bureau of Investigation (FBI), the Central
Intelligence Agency (CIA), the Defense Intelligence Agency (DoD/DIA),
and the U.S. Postal Service (USPS).
The Current List of Select Agents and Toxins
The current list of select agents and toxins was previously
published in the Federal Register on October 24, 1996 and appears as
Appendix A to 42 CFR part 72. In June 2002, CDC convened an interagency
working group to review the current list of select agents and toxins
and develop recommendations regarding possible changes to the list. CDC
has reviewed those recommendations and this notice of intent seeks to
solicit comments from the public on potential changes to the current
list of select agents and toxins. Of the 36 select agents and toxins on
CDC's current list, 18 of these appear on the USDA list of agents and
toxins required under Section 212(a) and located in 9 CFR 121.2(a).
These 18 agents and toxins appear on both the CDC and USDA lists since
they pose a risk to both human and animal health. Because the process
of changing the list of select agents and toxins was in the initial
stages when USDA published its interim rule on August 8, 2002 and when
this CDC notice of intent is being published, the list of agents and
toxins found in both 42 CFR part 72, Appendix A, and 9 CFR 121.2(a)
reflects the select agent list promulgated by CDC in October 1996. The
notification requirement for persons in possession of any select agent
as published by CDC on July 12, 2002 and USDA on August 8, 2002,
applies to the current list of agents and toxins and is unaffected by
the information solicited by this notice.
Summary of Changes to Appendix A, 42 CFR Part 72, That Are Under
Consideration
The following changes are being considered to the list of Viruses:
1. Rename ``Equine Morbillivirus'' to ``Nipah and Hendra Complex
viruses''.
2. Change ``Tick-borne encephalitis complex viruses'' to ``Tick-
borne encephalitis complex (flavi) viruses (Central European Tick-borne
encephalitis, Far Eastern Tick-borne encephalitis (Russian Spring and
Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic
Fever))''.
3. Delete: ``Viruses causing hantavirus pulmonary syndrome'' and
``Yellow fever virus''.
4. Add: ``Monkeypox virus'' and ``Herpes B virus''.
5. Remove: exemptions list since exemptions will be covered in the
Interim Final Rule.
The following changes are being considered to the list of Bacteria:
1. Remove ``(Pseudomonas)'' from the name of ``Burkholderia
(Pseudomonas) mallei'' and ``Burkholderia (Pseudomonas) pseudomallei''.
2. Change ``Clostridium botulinum'' to ``Botulinum neurotoxin
producing strains of Clostridium''.
3. Remove the header: Rickettsiae and combine these agents with the
agents in the bacteria list.
4. Remove: exemptions list since this will be covered in the
Interim Final Rule.
The following change is being considered to the list of Fungi:
1. Change Coccidioides immitis to Coccidioides immitis, C.
posadasii.
The following changes are being considered to the list of Toxins:
1. Remove: ``Aflatoxins''.
2. Change ``Botulinum toxins'' to ``Botulinum neurotoxins''.
3. Change ``Shigatoxin'' to ``Shigatoxin and Shiga-like toxins''.
The following change is being considered for Exemptions:
1. Change ``Exemptions: Toxins for medical use, inactivated for use
as vaccines, or toxin preparations for biomedical research use at an
LD 50 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.''
to ``Exemptions: Toxin preparations containing [le] 1 mg of Botulinum
neurotoxins; [le] 10 mg of Staphylococcal enterotoxins; or [le] 100 mg
of Abrin, Clostridium perfringens epsilon toxin, Conotoxins,
Diacetoxyscirpenol, Ricin, Saxitoxin, Shigatoxin and Shiga-like toxins,
Tetrodotoxin, or T-2 toxin, are exempt. Toxin preparation stored in
more than one location within a facility must be aggregated in
determining if the exemption applies. The medical use of toxins for
patient treatment are exempt.''
[[Page 54607]]
The following changes are being considered to Recombinant
Organisms/Molecules:
1. Change title ``Recombinant Organisms/Molecules'' to ``Genetic
Elements, Recombinant Nucleic Acids, and Recombinant Organisms''.
2. Change ``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.'' to:
``1. Full length nucleic acids (synthetic or naturally derived) of
any of the viruses listed in Appendix A.
2. Nucleic acids (synthetic or naturally derived) of 100
nucleotides or more in length of Variola major virus (smallpox virus).
3. Nucleic acids (synthetic or naturally derived) of bacteria,
fungi, or viruses listed in Appendix A that encode for either a
functional toxin or virulence factor sufficient to cause disease if the
nucleic acid is: (1) Expressed in vivo or in vitro; (2) in an
expression vector or host chromosome; or (3) in a carrier plasmid.
4. Nucleic acids (synthetic or naturally derived) that encode for
functional form of any of the toxins listed in Appendix A if: (1)
Expressed in vivo or in vitro; (2) in an expression vector or host
chromosome; or (3) in a carrier plasmid.
5. Microorganisms in Appendix A that have been genetically
modified.''
Finally, CDC is considering the following change to Additional
Exemptions:
1. Remove the following text since exemptions will be addressed in
the Interim Final Rule:
``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 and
toxins 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.''
List of Select Agents and Toxins
The following is the list of select agents and toxins that is being
considered for adoption:
Viruses
1. Crimean-Congo haemorrhagic fever virus
2. Eastern Equine Encephalitis virus
3. Ebola viruses
4. Herpes B virus
5. Lassa fever virus
6. Marburg virus
7. Monkeypox virus
8. Nipah and Hendra Complex viruses
9. Rift Valley fever virus
10. South American Haemorrhagic fever viruses (Junin, Machupo, Sabia,
Flexal, Guanarito)
11. Tick-borne encephalitis complex (flavi) viruses (Central European
Tick-borne encephalitis, Far Eastern Tick-borne encephalitis (Russian
Spring and Summer encephalitis, Kyasanur Forest disease, Omsk
Hemorrhagic Fever))
12. Variola major virus (Smallpox virus)
13. Venezuelan Equine Encephalitis virus
Bacteria
1. Bacillus anthracis
2. Brucella abortus
3. Brucella melitensis
4. Brucella suis
5. Burkholderia mallei
6. Burkholderia pseudomallei
7. Botulinum neurotoxin producing strains of Clostridium
8. Coxiella burnetii
9. Francisella tularensis
10. Rickettsia prowazekii
11. Rickettsia rickettsii
12. Yersinia pestis
Fungi
1. Coccidioides immitis
2. Coccidioides posadasii
Toxins
1. Abrin
2. Botulinum neurotoxins
3. Clostridium perfringens epsilon toxin
4. Conotoxins
5. Diacetoxyscirpenol
6. Ricin
7. Saxitoxin
8. Shigatoxin and Shiga-like toxins
9. Staphylococcal enterotoxins
10. Tetrodotoxin
11. T-2 toxin
Exemptions: Toxin preparations containing [le]1 mg of Botulinum
neurotoxins; [le]10 mg of Staphylococcal enterotoxins; or [le]100 mg of
Abrin, Clostridium perfringens epsilon toxin, Conotoxins,
Diacetoxyscirpenol, Ricin, Saxitoxin, Shigatoxin and Shiga-like toxins,
Tetrodotoxin, or T-2 toxin, are exempt. Toxin preparation stored in
more than one location within a facility must be aggregated in
determining if the exemption applies. The medical use of toxins for
patient treatment are exempt.
Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms
1. Full length nucleic acids (synthetic or naturally derived) of
any of the viruses listed in Appendix A.
2. Nucleic acids (synthetic or naturally derived) of 100
nucleotides or more in length of Variola major virus (smallpox virus).
3. Nucleic acids (synthetic or naturally derived) of bacteria,
fungi, or viruses listed in Appendix A that encode for either a
functional toxin or virulence factor sufficient to cause disease if the
nucleic acid is: (1) Expressed in vivo or in vitro; (2) in an
expression vector or host chromosome; or (3) in a carrier plasmid.
4. Nucleic acids (synthetic or naturally derived) that encode for
functional form of any of the toxins listed in Appendix A if: (1)
Expressed in vivo or in vitro; (2) in an expression vector or host
chromosome; or (3) in a carrier plasmid.
5. Microorganisms in Appendix A that have been genetically
modified.
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 currently prohibited if such acquisition could
compromise the use of the drug to control these disease agents in
humans or veterinary medicine.
Dated: August 9, 2002.
Julie Louise Gerberding,
Director, Centers for Disease Control and Prevention.
[FR Doc. 02-21512 Filed 8-20-02; 4:01 pm]
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