2010-17728. 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.

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: [e-mail].

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: [phone].

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 into two sections. The select agents and toxins listed in § 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 § 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.