[Federal Register Volume 75, Number 139 (Wednesday, July 21, 2010)]
[Proposed Rules]
[Pages 42363-42364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17728]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 73

RIN 0920-AA34


Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002; Biennial Review and Republication of the Select Agent and 
Toxin List

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

ACTION: Advance notice of proposed rulemaking and request for comments.

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SUMMARY: The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (42 U.S.C. 262a) (the Bioterrorism Act) requires 
the biennial review and republication of the HHS list of select agents 
and toxins. Accordingly, we are soliciting public comment on the 
current HHS list of select agents and toxins, including whether any 
biological agent or toxin should be added to or removed from the list. 
We are also seeking comments as to whether we should ``tier'' the HHS 
select agent list based on the relative bioterrorism risk of each agent 
or toxin and possibly further ``stratify'' the security requirements 
for agents in the highest tier based on type of use or other factors.

DATES: We will consider all comments received on or before August 20, 
2010.

ADDRESSES: Comments in response to this notice 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 Bioterrorism Act requires the HHS 
Secretary to establish by regulation a list of each biological agent 
and 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 considers the effect on human health 
upon exposure to the agent or toxin; the degree of contagiousness of 
the agent; 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 the agent 
or toxin; the potential for the agent or toxin to be used as a 
biological weapon; and the needs of children and other vulnerable 
populations. The current list of HHS biological select agents and 
toxins can be found at http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html. The Bioterrorism Act 
requires that the HHS Secretary review and republish the HHS list of 
select agents and toxins on at least a biennial basis.

Background

    The HHS Secretary last republished the HHS select agent and toxin 
list in the Federal Register on October 16, 2008 (73 FR 61363). The HHS 
select agent and toxin list, found in part 73 of Title 42 of the Code 
of Federal Regulations (42 CFR part 73), is divided

[[Page 42364]]

into two sections. The select agents and toxins listed in Sec.  73.3 
(HHS select agents and toxins) are those regulated only by HHS under 
the authority of the Bioterrorism Act. The select agents and toxins 
listed in Sec.  73.4 (Overlap select agents and toxins) are those 
regulated by HHS under the authority of the Bioterrorism Act and 
regulated by Secretary of Agriculture (USDA) under the authority of the 
Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401).
    To fulfill this statutory mandate, CDC's Division of Select Agents 
and Toxins (DSAT) has initiated its biennial review process which will 
include consultation with subject matter experts including the 
Intragovernmental Select Agents and Toxins Technical 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/Center 
for Veterinary Biologics (CVB), the Department of Homeland Security 
(DHS), and the Department of Defense (DOD).
    The purpose of this advanced notice of proposed rulemaking is to 
seek public comment on (1) the appropriateness of the current HHS list 
of select agents and toxins, (2) whether there are other agents or 
toxins that should be added to the HHS list, (3) whether agents or 
toxins currently on the HHS list should be deleted from the list, (4) 
whether the HHS select agent list should be tiered based on the 
relative bioterrorism risk of each agent or toxin, and (5) whether the 
security requirements for agents in the highest tier should be further 
stratified based on type of use or other factors.
    A recent report by the National Research Council recommended that 
the select agent list should be ordered based on the potential of an 
agent to be used as a biothreat, and a graded series of security 
procedures should be applied so that the greatest resources and 
scrutiny go to securing agents that pose a maximum risk (http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12774). As 
noted above, we are also seeking public comment on whether the HHS list 
should be tiered based on the relative bioterrorism risk of each agent 
or toxin and whether the security requirements for agents in the 
highest tier should be further stratified based on type of use or other 
factors. If a commenter believes that the HHS list should be tiered 
and/or stratified, we would also be interested in what criteria should 
be used to designate higher-risk agents, and what, if any, changes we 
should make in security requirements for what would be determined to be 
higher-risk agents.
    If implemented, tiering of the HHS select agent list could allow 
for the application of more stringent security measures for those 
select agents or toxins which pose a higher risk to public health and 
safety if stolen or misused. If implemented, stratification of the HHS 
select agent list could allow for varying levels of security 
requirements for entities that possess the highest tier agents, based 
on use of the agent or other factors. If a commenter believes that 
tiering and/or stratification of the HHS select agent list is 
advisable, we would be interested in comments as to what criteria 
should be used to designate which agents and toxins pose a higher 
bioterrorism risk and what criteria should be used for stratifying the 
highest risk agents. For example, the tiering and/or stratification of 
the HHS select agent list might consider the relative ease with which a 
particular agent or toxin might be disseminated or transmitted between 
humans or throughout the environment; the potential for high mortality 
rates; the potential for a major public health impact; whether misuse 
of an agent or toxin might result in public panic or other social or 
economic disruption; and whether the agent or toxin requires Federal, 
State and local officials to take special action in planning for major 
public health disasters (quarantine needs, eradicated agent or toxin). 
Additionally, we would also be interested in what corresponding changes 
should be made to the security requirements found in 42 CFR 73.11 to 
increase protection for higher tier agents or toxins; whether those 
security requirements should be stratified based on the use of the 
agent or other factors; and whether such changes should be prescriptive 
(the imposition of specific restraints, restrictions, or requirements) 
or risk-based (security requirement based on a security risk 
assessment), or a combination of prescriptive and risk-based.
    Following the conclusion of CDC review, we will publish another 
notice in the Federal Register either proposing that the select agent 
and toxin list remain the same, or that specific biological agents or 
toxins be added to or deleted from the list. If appropriate, we will 
also propose any changes to the Select Agent regulations (42 CFR Part 
73) to implement a tiering and/or stratification schema along with any 
corresponding amendments to the current security requirements in the 
Select Agent regulations that might be required for higher-risk agents 
and toxins.
    This action has been determined to be significant for the purposes 
of Executive Order 12866 and, therefore, has been reviewed by the 
Office of Management and Budget.

    Authority: 42 U.S.C. 262a.

    Dated: January 8, 2010.
Kathleen Sebelius,
Secretary.

    Editorial Note: This document was received in the Office of the 
Federal Register on July 15, 2010.

[FR Doc. 2010-17728 Filed 7-20-10; 8:45 am]
BILLING CODE 4163-18-P