Possession, Use, and Transfer of Select Agents and Toxins, 49244-49245 [07-4233]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 166 (Tuesday, August 28, 2007)]
[Proposed Rules]
[Pages 49244-49245]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-4233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 73


Possession, Use, and Transfer of Select Agents and Toxins

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The select agents and toxins listed in 42 CFR part 73 include 
those regulated only by the U.S. Department of Health and Human 
Services (HHS) (42 CFR 73.3), as well as those overlap select agents 
and toxins regulated by both HHS and the U.S. Department of Agriculture 
(USDA) (42 CFR 73.4). In response to USDA's proposal to no longer 
regulate ten select agents and toxins currently listed as ``overlap'' 
agents and toxins, we are proposing to move those ten select agents and 
toxins from the overlap select agents and toxins section to the HHS 
select agents and toxins section.

DATES: Written comments must be received on or before October 29, 2007. 
Comments received after October 29, 2007 will be considered to the 
extent practicable.

ADDRESSES: Comments on the changes to the list of select agents and 
toxins should be marked ``Comments on the changes to the list of select 
agents and toxins'' and mailed to: Centers for Disease Control and 
Prevention, Division of Select Agents and Toxins, 1600 Clifton Road, MS 
A-46, Atlanta, GA 30333. Comments may be e-mailed to: 
SAPcomments@cdc.gov.

FOR FURTHER INFORMATION CONTACT: Robbin Weyant, Director, Division of 
Select Agents and Toxins, Centers for Disease Control and Prevention, 
1600 Clifton Rd., MS A-46, Atlanta, GA 30333. Telephone: (404) 718-
2000.

SUPPLEMENTARY INFORMATION: The Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, Subtitle A of Public Law 107-188 
(42 U.S.C. 262a) (the Bioterrorism Preparedness Act), required the HHS 
Secretary to establish by regulation a list of each biological agent 
and each toxin that has the potential to pose a severe threat to public 
health and safety. In determining whether to include an agent or toxin 
on the list, the HHS Secretary considered the effect on human health of 
exposure to an agent or toxin; the degree of contagiousness of the 
agent or toxin and the methods by which the agent or toxin is 
transferred to humans; the availability and effectiveness of 
pharmacotherapies and immunizations to treat and prevent illnesses 
resulting from an agent or toxin; the potential for an agent or toxin 
to be used as a biological weapon; and the needs of children and other 
vulnerable populations. Once established, the Bioterrorism Preparedness 
Act requires that the HHS Secretary review and republish the list of 
select agents and toxins on at least a biennial basis.
    The HHS Secretary promulgated the current select agents and toxins 
list in a final rule amending Part 73 of title 42 of the Code of 
Federal Regulations, published on March 18, 2005, and made effective on 
April 18, 2005. The select agents and toxins list found in Part 73 is 
divided into two sections. The select agents and toxins listed in 
section 73.3 (HHS select agents and toxins) are those select agents and 
toxins regulated only by HHS. The select agents and toxins listed in 
section 73.4 (Overlap select agents and toxins) are those select agents 
and toxins regulated by HHS and USDA under the provisions of the 
Agricultural Bioterrorism Protection Act of 2002.
    The Agricultural Bioterrorism Protection Act of 2002, Subtitle B of 
Public Law 107-188 (7 U.S.C. 8401) (the Agricultural Bioterrorism 
Protection Act), requires the USDA Secretary to establish by regulation 
a list of each biological agent and each toxin that the Secretary 
determines has the potential to pose a severe threat to animal or plant 
health or animal or plant products. In determining whether to include 
an agent or toxin on the list, the USDA Secretary considered the effect 
of exposure to the agent or toxin on animal or plant health, and on the 
production and marketability of animal or plant products; the 
pathogenicity of the agent or the toxicity of the toxin and the methods 
by which the agent or toxin is transferred to animals and plants; the 
availability and effectiveness of pharmacotherapies and prophylaxis to 
treat and prevent any illness caused by the agent or toxin; and the 
potential of an agent or toxin for use as a biological weapon. The USDA 
Secretary is also required to conduct a biennial review of the USDA 
select agents and toxins list.
    HHS completed its biennial review on February 22, 2007 and 
determined that it would neither add nor remove any agents or toxins 
from its select agents and toxins list. To assist with the biennial 
review, HHS reviewed recommendations provided by subject matter experts 
and the Intragovernmental Select Agents and Toxins Advisory Committee 
(ISATTAC). The ISATTAC is comprised of Federal government employees 
from the CDC, the National Institutes of Health (NIH), the Food and 
Drug Administration (FDA), the USDA/Animal and Plant Health Inspection 
Service (APHIS), USDA/Agricultural Research Service (ARS), USDA/CVB 
(Center for Veterinary Biologics) and the Department of Defense (DOD).
    After conducting its biennial review, USDA has proposed that it 
will no longer regulate ten of the select agents and toxins currently 
listed as ``overlap'' select agents and toxins in section 73.4. If 
their decision becomes final, HHS will move those ten select agents and 
toxins from section 73.4 to section 73.3. Published in today's Federal 
Register is USDA's proposal to remove from Part 121 of Title 9 of the 
Code of Federal Regulations the following agents and toxins: Botulinum 
neurotoxins; Botulinum neurotoxin producing species of Clostridium, 
Coxiella burnetti, Francisella tularensis, Coccidioides immitis, 
Eastern equine encephalitis virus, T-2 toxin, Staphylococcal 
enterotoxins, Shigatoxin, and Clostridium perfringens epsilon toxin. 
Comments regarding USDA's proposal to no longer regulate ten select 
agents and toxins currently listed as ``overlap'' agents and toxins 
should be sent to USDA.

Regulatory Analyses

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), requires 
that the HHS consider the impact of paperwork and other information 
collection burdens imposed on the public. We have determined no new 
information collection requirements are associated with this proposed 
rule.

Executive Order 12866 and Regulatory Flexibility Act

    This action has been determined not significant for purposes of 
Executive Order 12866, and therefore, has not been reviewed by the 
Office of Management and Budget. The Regulatory Flexibility Act (5 
U.S.C. 601

[[Page 49245]]

et seq.) requires an agency to review regulations to assess their 
impact on small entities unless the agency determines that a rule is 
not expected to have a significant impact on a substantial number of 
small entities. This rule will have no costs because it merely changes 
the designation of ten select agents and toxins from being regulated by 
both HHS and USDA to being regulated solely by HHS. We hereby certify 
this proposed rule will not have a significant economic impact on a 
substantial number of small businesses.

Unfunded Mandates

    The Unfunded Mandates Reform Act at 2 U.S.C. 1532 requires that 
agencies prepare an assessment of anticipated costs and benefits before 
developing any rule that may result in expenditure by State, local, or 
tribal governments, in the aggregate, or by the private sector of $100 
million or more (adjusted for inflation) in any given year. This 
proposed rule is not expected to result in any one-year expenditure 
that would exceed this amount.

Executive Order 12988

    This Notice of Proposed Rulemaking has been reviewed under 
Executive Order 12988, Civil Justice Reform. This rule: (1) Would 
preempt all State and local laws and regulations that are inconsistent 
with this rule; (2) would have no retroactive effect; and (3) would not 
require administrative proceedings before parties may file suit in 
court challenging this rule.

Executive Order 13132

    This Notice of Proposed Rulemaking has been reviewed under 
Executive Order 13132, Federalism. The notice does not propose any 
regulation that would preempt State, local, and Indian tribe 
requirements, or that would have any substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.

List of Subjects in 42 CFR Part 73

    Biologics, Incorporation by reference, Packaging and containers, 
Penalties, Reporting and Recordkeeping requirements, Transportation.

    Dated: August 17, 2007.
Michael O. Leavitt,
Secretary.

    For the reasons stated in the preamble, we are proposing to amend 
42 CFR part 73 as follows:

PART 73--SELECT AGENTS AND TOXINS

    1. The authority citation for part 73 continues to read as follows:

    Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of 
Title II of Public Law No. 107-188, 116 Stat. 637 (42 U.S.C. 262a).

    2. Amend paragraph (b) of Sec.  73.3 by adding the following 
entries in alphabetical order and revising the entry for Coccidioides 
posadasii to read as follows:


Sec.  73.3  HHS select agents and toxins.

* * * * *
    (b) * * *
    Botulinum neurotoxins
    Botulinum neurotoxin producing species of Clostridium
* * * * *
    Clostridium perfringens epsilon toxin
    Coccidioides posadasii/Coccidioides immitis
* * * * *
    Coxiella burnetii
* * * * *
    Eastern Equine Encephalitis virus
* * * * *
    Francisella tularensis
* * * * *
    Shigatoxin
* * * * *
    Staphylococcal enterotoxins
    T-2 toxin
* * * * *
    3. Amend paragraph (d)(3) of Sec.  73.3 by adding the following 
entries in alphabetical order: 05. mg of Botulinum neurotoxins; 100 mg 
of Clostridium perfringens epsilon toxin; 100 mg of Shigatoxin; 5 mg of 
Staphylococcal enterotoxins; or 1,000 mg of T-2 toxin.
    4. Amend paragraph (f)(3)(i) of Sec.  73.3 by adding the following 
entries in alphabetical order: Botulinum neurotoxins and Francisella 
tularensis.


Sec.  73.5  [Amended]

    5. Amend paragraph (a)(3)(i) of Sec.  73.5 by adding the following 
entries in alphabetical order: Botulinum neurotoxins and Francisella 
tularensis.


Sec.  73.4  [Amended]

    6. Amend paragraph (b) of Sec.  73.4 by removing the entries for 
Botulinum neurotoxins, Botulinum neurotoxin producing species of 
Clostridium, Clostridium perfringens epsilon toxin, Coccidioides 
immitis, Coxiella burnetii, Eastern Equine Encephalitis virus, 
Francisella tularensis, Shigatoxin, Staphylococcal enterotoxins, and T-
2 toxin.
    7. Remove paragraph (d)(3) of Sec.  73.4.
    8. Amend paragraph (f)(3)(i) of Sec.  73.4 by removing the 
following entries: Botulinum neurotoxins and Francisella tularensis.


Sec.  73.6  [Amended]

    9. Amend paragraph (a)(3)(i) of Sec.  73.6 by removing the 
following entries: Botulinum neurotoxins and Francisella tularensis.

[FR Doc. 07-4233 Filed 8-27-07; 8:45 am]
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