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Frequently asked questions concerning General Information
Legislature, Regulation, and Guidelines
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What is the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and how do I find a copy?
On June 12, 2002, President Bush signed the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (the Act). The Act is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.
Section 201(a) of the Act amends the Public Health Service Act (42 U.S.C. 262a) by requiring all persons possessing, using or transferring biological agents or toxins designated by the Secretary of the U.S. Department of Health and Human Services (HHS Secretary) as having the potential to pose a severe threat to public health and safety (i.e., HHS select agents and toxins) to register with the HHS Secretary and meet biosafety and security procedures established by the HHS Secretary.
Section 212 of the Act requires all persons possessing, using or transferring biological agents or toxins designated by the Secretary of the U.S. Department of Agriculture as having the potential to pose a severe threat to animal or plant health and to animal or plant products (i.e. USDA select agents and toxins) to register with the USDA Secretary and meet biosafety and security procedures established by the USDA Secretary.
The HHS Select Agent regulations can be found in part 73 of Title 42 of the Code of Federal Regulations (42 CFR 73).
The USDA Select Agent regulations covering threats to animals and animal products can be found at part 121 of Title 9 Code of Federal Regulations (9 CFR 121). The USDA Select Agent regulations covering threats to plants and plant products can be found at part 331 of Title 7 Code of Federal Regulations (7 CFR 331).
The Centers for Disease Control and Prevention (CDC) has been designated as the HHS agency responsible for promulgating, implementing, and providing guidance on 42 CFR 73.
The Animal and Plant Health Inspection Service (APHIS) has been designated as the USDA agency responsible for promulgating, implementing, and providing guidance on 9 CFR 121 and 7 CFR 331.
The Act can be found at the Federal Register website http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ188.107.
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What is the USA PATRIOT Act and how do I find a copy?
On October 26, 2001, President Bush signed the “Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism” (USA PATRIOIT) Act. The law places restrictions on persons who possess select agents and provides criminal penalties for possession of any biological agent that cannot be justified for specified peaceful purposes. More information on the USA PATRIOT Act can be found at Department of Justice website http://www.justice.gov/archive/ll/highlights.htm
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What are the Select Agent Regulations and how do I find a copy?
The Select Agent Regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73) implement the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 setting forth the requirements for possession, use, and transfer of select agents and toxins. Select agents and toxins are those biological agents and toxins that have the potential to pose a severe threat to public health and safety, to animal health, or to animal products. The Select Agent Regulations can be found at http://www.selectagents.gov/Regulations.html.
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Adding "reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments" to the HHS Select Agents and Toxins List
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What is the ISATTAC?
ISATTAC stands for the Intragovernmental Select Agents and Toxins Technical Advisory Committee and is an inter-agency work group. The ISATTAC assists the CDC DSAT in implementing the provisions of 42 C.F.R. Part 73.
It is comprised of Federal government employees from the CDC, the NIH, the 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).
The ISATTAC provides recommendations to the CDC DSAT in the following three technical areas: (1) review of requests for the exclusion of attenuated strains, (2) review of requests to conduct restricted experiments, and (3) review of requests for addition or deletion of agents or toxins to the Select Agents list.
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Did the ISATTAC review the reconstructed 1918 pandemic influenza virus for inclusion on the HHS Select Agents and Toxins list?
Yes. On September 30, 2005, the CDC DSAT called an emergency meeting of the ISATTAC to consider if the reconstructed 1918 pandemic influenza virus should be added to the HHS Select Agents and Toxins list. Authors of the paper "Characterization of the reconstructed 1918 Spanish influenza pandemic virus," published in Science on October 7, 2005, presented the findings and characteristics of this reconstituted virus to the Committee. The Committee reviewed the findings and unanimously advised the CDC DSAT that this agent should be added to the HHS list of Select Agents and toxins. The HHS then requested an expedited clearance of an Interim final rule to add "replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments" to the list of HHS Select Agents and toxins.
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Why is this agent being added immediately to the HHS Select Agents and toxins list?
The complete coding sequence for the 1918 pandemic influenza A H1N1 virus has been recently identified (Taubenberger et al. 2005, Nature, vol. 437, pp. 889-893). Scientists from the CDC together with collaborators at Mount Sinai School of Medicine, NY, Armed Forces Institute of Pathology, MD, and Southeast Poultry Research Laboratory, USDA, GA, reconstructed the 1918 pandemic influenza virus by using reverse genetics to study the properties associated with its extraordinary virulence (Tumpey et al., Characterization of the Reconstructed 1918 Spanish Influenza Pandemic Virus, Science 2005 310: 77-80). With the publication of the complete coding sequence, it will be possible for other scientists with knowledge of reverse genetics technology to reconstruct the 1918 pandemic influenza virus at other institutions.
In making its recommendation, the ISATTAC considered both the historical data regarding the original 1918 pandemic influenza virus and data from current in vitro and in vivo animal studies. The apparent virulence of this virus, together with the fact that the level of immunity in the general population and the ability of the virus to readily transmit among persons are unknown at this time, makes it prudent to immediately regulate this virus as a Select Agents.
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What do I need to do if I want to register to possess, use, or transfer this agent?
The addition of the reconstructed 1918 pandemic influenza virus to the HHS Select Agents and toxins list is effective upon publication of the Interim final rule. Entities that intend to possess, use, or transfer this agent will be required to either register in accordance with 42 C.F.R. part 73, or amend their current registration in accordance with § 73.7(h).
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What are the appropriate biosafety practices and containment conditions for work with this agent?
The "Interim CDC-NIH Recommendation for Raising the Biosafety Level for Laboratory Work Involving Noncontemporary Human Influenza Viruses" (http://www.cdc.gov/flu/h2n2bsl3.htm) excerpted from the draft CDC/NIH "Biosafety in Microbiological and Biomedical Laboratories," 5th edition will be used as the minimum containment for such experiments. However, in some cases supplemental biosafety measures may be deemed appropriate after review of the proposed experiments by CDC DSAT.
The CDC DSAT will review the entity’s biosafety plan to ensure that it provides a comprehensive risk assessment of the proposed research and adequately ensures appropriate biosafety measures. The case-by-case review will continue until further data are available that may result in changes to biosafety guidelines for work with the reconstructed 1918 pandemic influenza virus.
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Publication of Information
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Is there a restriction on the publication of Select Agents Information?
The Select Agents regulations (42 CFR 73, 9 CFR 121, and 7 CFR 331) place no specific restrictions on the publication of Select Agents research findings. However, any records or information systems that could allow an individual to gain access to the Select Agents or toxins should be safeguarded to prevent unauthorized access, theft, loss, or release of these materials. APHIS and CDC strongly encourage entities to refrain from publishing detailed information about Select Agents and Toxin locations, quantities on site, or researchers. APHIS and CDC consider all information provided to the Select Agents Programs in APHIS/CDC Forms 1, 2, 3, 4, and 5 to be "Sensitive but Unclassified (SBU)." Publication of SBU information could compromise the security and safety of the regulated community, public, animals, plants, and homeland security. APHIS and CDC do not release site-specific or identifying information associated with the Select Agents regulations (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121) to the public.
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Reporting Incidents Involving Select Agents and Toxins
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How can I report suspicious activity that may be criminal in nature concerning a registered entity, its personnel, or its select agents or toxins?
You can notify a Federal Bureau of Investigation Weapons of Mass Destruction Coordinator of any suspicious activity that you believe may be criminal in nature concerning an entity, its personnel, or its select agents or toxins. To locate your Federal Bureau of Investigation Weapons of Mass Destruction Coordinator, refer to http://www.fbi.gov/contact-us/field .
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Is it possible for me to report a safety or security issue related to a select agent or toxin without identifying myself?
The Federal Select Agent Program has established a confidential means for reporting safety and security issues associated with the possession, use and transfer of select agents and toxins. The Department of Health & Human Services, Office of Inspector General (OIG) maintains a hotline that allows individuals to anonymously report fraud, waste and abuse in all departmental programs. This hotline is now available to anonymously report safety or security issues related to select agents and toxins. When reporting these issues to OIG, please ensure that you indicate it is a "Select Agent Program" issue.
OIG Hotline contact information:
| Voice: |
1-800-HHS-TIPS (800-447-8477) |
| Fax: |
1-800-223-8164 |
| Web: |
http://oig.hhs.gov/fraud/hotline |
Mail: |
Office of Inspector General
Department of Health & Human Services
Attn: Hotline
P.O. Box 23489
Washington, DC 20026
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