General Questions Concerning the National Select Agents Registry Website

1. How do I open a PDF form?
2. Where can I find more information about the APHIS / CDC Select Agents Programs?

General Questions Concerning Select Biological Agents and Toxins

1. What is the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and how do I find a copy?
2. What is the USA PATRIOT Act and how does it relate to the Select Agents regulation? Where can I find a copy?
3. What is a Select Agents or Toxin ("Select Agents")? What is a High Consequence Pathogen and Toxin? What is an Overlap Agent? How do they differ?
4. Why do I need to register with HHS and USDA for Select Agents that I may possess or use?

General Questions Regarding the Select Agents Regulation (42 CFR 73, 9 CFR 121, and 7 CFR 331)

1. Where can I find a copy of the final rule?
2. How was the Select Agents list determined?
3. What is an entity?
4. Where can I obtain an application?
5. What agency should the application be submitted to?
6. What is a lead agency? Which one do I use?
7. What does the registration cover?
8. What if we need to update, change, or amend our registration?
9. Who is exempt from the Select Agents regulation?
10. Under what conditions is an entity excluded from the Select Agents regulation (42 CFR 73, 9 CFR 121, and 7 CFR 331)?
11. What is the difference between an "exemption" and "exclusion" in the context of 42 CFR Part 73, 9 CFR 121, and 7 CFR 331?
12. What do entities that plan to conduct training at their facilities need to do in order to meet the requirements of 42 CFR 73, 9 CFR 121, and 7 CFR 331?
13. Where can I find information regarding security risk assessments?

General Questions Regarding 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

1. What is the ISATTAC?
2. Did the ISATTAC review the reconstructed 1918 pandemic influenza virus for inclusion on the HHS Select Agents and Toxins list?
3. Why is this agent being added immediately to the HHS Select Agents and toxins list?
4. What do I need to do if I want to register to possess, use, or transfer this agent?
5. What are the appropriate biosafety practices and containment conditions for work with this agent?

General Questions Regarding Publication of Information

1. Is there a restriction on the publication of Select Agents Information?

General Questions Concerning the National Select Agents Registry Website

1. How do I open a PDF form?

   You will need the Adobe Acrobat Reader 6.0 or above on your computer and configured to work on your browser to access the file.

   If you do not have the latest version of Adobe Acrobat Reader, you may download a free copy from adobe.

   
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2. Where can I find more information about the APHIS / CDC Select Agents Programs?

   You can find more information about the APHIS Select Agents Program on their website. You can find more information about the CDC Select Agents Program on their website.

   
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General Questions Concerning Select Biological Agents and Toxins

1. 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 Response Act of 2002" (Public Law 107-188). The law is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. Section 202(a) of the Law requires that all persons possessing biological agents or toxins deemed a threat to public health to notify the Secretary, Department of Health and Human Services (HHS). Section 213(b) of Law requires all persons possessing biological agents or toxins deemed a threat to animal or plant health and to animal or plant products notify the Secretary, United States Department of Agriculture (USDA).

   The Law also requires that both Secretaries be notified when a person possesses agents that appear on both the HHS and the USDA list of agents and toxins. These agents and toxins have been designated HHS/USDA overlap agents.

   The Centers for Disease Control and Prevention (CDC) has been designated as the HHS agency responsible for providing guidance on this notification. The Animal and Plant Health Inspection Service (APHIS) has been designated as the USDA agency responsible for providing guidance on this notification.

   For more information on the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188) see: this page.

   Subsequent to the enactment of Public Law 107-188, requirements for facilities or entities that possess, use, or transfer Select Agents and toxins have been published by HHS (42 CFR 73; December 13, 2002) and by USDA (9 CFR 121 and 7 CFR 331; December 13, 2002).

   
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2. What is the USA PATRIOT Act and how does it relate to the Select Agents regulation? Where can I find a copy?

   The USA PATRIOT Act is a law signed by President Bush on October 26, 2001, that places restrictions on persons who possess Select Agents and provides criminal penalties for possession of such agents that cannot be justified for specified peaceful purposes. More information on the USA PATRIOT Act can be found at the life and liberty website.

   
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3. What is a Select Agents or Toxin ("Select Agents")? What is a High Consequence Pathogen and Toxin? What is an Overlap Agent? How do they differ?

   Select Agents / toxins are agents that HHS considers to have the potential to pose a severe threat to human health. A list of these agents are found in the Select Agents regulation (42 CFR 73).

   High Consequence Livestock Pathogens and Toxins are agents that the USDA considers to have the potential to pose a severe threat to animal or plant health, or to animal or plant products.

   The plant pathogens listed by USDA have been deemed a threat to plant health or products.

   Agents that post a severe threat to animal health, animal products and also public health are referred to as "Overlap Agents." These agents appear on both the HHS and USDA list of agents and toxins.

   A listing of each of these agents / toxins can be found on the Select Agents and toxins page.

   
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4. Why do I need to register with HHS and USDA for Select Agents that I may possess or use?

   Agents identified under the HHS and USDA lists of biological Select Agents and toxins or USDA's list of High Consequence Livestock Pathogens and Toxins have been deemed a potential threat to human, animal, plant health or animal / plant products.

   The registration of facilities possessing, using and transferring these agents or toxins is part of the government's efforts to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies and is required under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

   
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General Questions Regarding the Select Agents Regulation (42 CFR 73, 9 CFR 121, and 7 CFR 331)

1. Where can I find a copy of the final rule?

   The regulation published by HHS concerning HHS and HHS/USDA overlap Select Agents and toxins (42 CFR 73, March 18th, 2005) is available here (254KB PDF).

   The regulations published by CDC/APHIS for HHS/USDA overlap and USDA high consequence livestock and pathogens and for listed plant agents (9 CFR 121 and 7 CFR 331, March 18th, 2005) are available in one document here (333KB PDF).

   
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2. How was the Select Agents and Toxin list determined?

   CDC prepared the Select Agents list for 42 CFR 73 after receiving extensive input from scientists representing 21 Federal government entities. The proposed list was first published in the Federal Register for public comment on August 23, 2002.

   The HHS Secretary considered the following criteria for establishing the list as directed in 42 U.S.C. 262a (a)(1)(B):

   • The effect on human health of exposure to the agent or toxin;
   • The degree of contagiousness of the agent or potency of the 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 any illness resulting from infection by the agent or toxin.

   APHIS prepared the Select Agents list for 9 CFR 121 and 7 CFR 331 after receiving extensive input from scientists representing 21 Federal government entities. The proposed list was first published in the Federal Register for public comment on August 23, 2002.

   The USDA Secretary considered the following criteria for establishing the list as directed in 7 U.S.C. 110 I (a)(1)(B):

   • The effect of an agent or toxin on animal or plant health or products;
   • The virulence of an agent or degree of toxicity of the toxin and the methods by which the agents or toxins are transferred to animals or plants;
   • The availability and effectiveness of medicines and vaccines to treat and prevent any illness caused by an agent or toxin.

   
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3. What is an entity?

   An entity is any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity.

   
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4. Where can I obtain an application?

   The application is available at http://www.selectagents.gov/RegistrationForm.html. We now have the application in a PDF fillable format as well as Excel templates of the tables contained in the application.

   
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5. What agency should the application be submitted to?

   The Responsible Official (RO) should submit the application electronically using this website.

   If a non-electronic submission is needed, the RO should contact the lead agency of the entity.

   • For CDC lead entities, the RO should contact CDC (email: cdclead@selectagents.gov; telephone: 404-498-2255; facsimile 404-498-2265).
   • For APHIS lead entities, the RO should contact APHIS (email: aphis@selectagents.gov; telephone: 301-734-3277; facsimile: 301-734-3652).

   
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6. What is a lead agency? Which one do I use?

   In order to minimize the burden to the public that register for Select Agents and toxins, CDC and APHIS are working together to provide a single point of contact. This single point of contact is referred to as the lead agency, and as such, is responsible for coordinating all activities and communications with respect to your registration, including coordination with both the non-lead agency and with FBI / CJIS. The lead agency will retain responsibility for your application through the life of your registration certificate (2-3 years), even if your entity chooses to discontinue registration of overlap agents.

   In most cases, the lead agency will be determined by the agents you possess. If you only have HHS Select Agents, then your lead agency is CDC. If you only have USDA Select Agents, then your lead agency is APHIS. If you possess a combination of HHS and USDA Select Agents / toxins or overlap agents, you may use either agency as your lead agency.

   A listing of all Select Agents and toxins in the Select Agents regulation are available on this page.

   
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7. What does the registration cover?

   The registration will only be valid for the specific Select Agents and toxins and the specific activities and locations consistent with the information which the certificate of registration or amendment is granted.

   
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8. What if we need to update, change, or amend our registration?

   Prior to any change, the Responsible Official (RO) must apply for an amendment to a certificate of registration by submitting the relevant page(s) of the registration application. This includes replacement of the RO or other personnel changes, changes in ownership or control of the entity, changes in the activities involving any Select Agents or toxins, or the addition or removal of Select Agents or toxins.

   
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9. Who is exempt from the 42 CFR 73, 9 CFR 121, and 7 CFR 331?

   An entity may be exempt from the provisions of the regulation, if:

   • The only activities that an entity conducts concerning Select Agents are processing diagnostic, verification or proficiency specimens or isolates (see § 73.6 for details on additional requirements for these laboratories. Also see number 8, below).
   • The entity has Select Agents or toxins that are cleared, approved, licensed, or registered under any of the laws specified in the regulation, and are used only for the approved purpose of such laws.
   • The entity applies to CDC and/or APHIS as appropriate for an exemption for Select Agents or toxins that are an investigational product authorized under a Federal Act listed in the regulation. CDC / APHIS form 5
   • An exemption is granted by CDC and/or APHIS due to a public health or agricultural emergency.

   
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10. Under what conditions is an entity excluded from the Select Agents regulation (42 CFR 73, 9 CFR 121, and 7 CFR 331)?

    The following are excluded from the regulation:

    • Select Agents or toxins that are in their naturally occurring environment, provided that it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
    • Non-viable Select Agents organisms or nonfunctional toxins.
    • The vaccine strain of Junin virus (Candid #1).
    • It is possible under the rule to apply for exclusion for any attenuated agent or toxin using an appropriate form obtainable from CDC. Exclusions for specific strains may be granted if the attenuated strain is determined not to pose a significant public health or safety threat. Exclusions for specific strains should be requested in writing and sent to the Select Agents Program. Exclusions will be published in the notice section of the Federal Register and will be listed on the NSAR website at http://www.selectagents.gov/Legislation.html
    • Exclusions for entities with specific quantities of toxins under the control of a principal investigator at a given time are also detailed in the regulation (see number 10, below).

    
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11. What is the difference between an "exemption" and "exclusion" in the context of 42 CFR Part 73?

    The "exemption" found in 42 CFR 73.4(f) and 42 CFR 73.5(f) apply to only to those biological agents and toxins designated in 42 CFR 73.4 and 42 CFR 73.5 as "HHS Select Agents and toxins" and "Overlap Select Agents and toxins," respectively. The practical effect is to exclude, in the circumstances and conditions specified in the regulation, a biological agent or toxin that has otherwise been listed as a Select Agents or toxin from the provisions of the regulations. The "exemption" set out in 42 CFR 73.4(f)(1)-(4) and 42 CFR 73.5(f)(1)-(4) are automatic. In addition, subsection (f)(5) of each section provides that, upon request, the Secretary may exclude attenuated strains of Select Agents or toxins upon a determination by the Secretary that they do not pose a severe threat to the public health and safety.

    The "Exemptions" found in 42 CFR 73.6 were mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. They list five different categories under which an entity; biological agent or toxin, or individual may be permanently or temporarily exempted from some or all of the provisions of Part 73 depending of the specifics of a particular exemption.

    
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12. What do entities that plan to conduct training at their facilities need to do in order to meet the requirements of 42 CFR 73?

    First, the entity responsible for the training should determine if the agents or toxins they wish to use in the training meet the definition of a Select Agents or toxin as defined in 42 CFR 73.4, 42 CFR 73.5, and 7 CFR 331.3 (a). Please note that some exclusions have been specified in 42 CFR 72.4(f)(1-4) and 42 CFR 72.5(f)(1-4). In addition, some Select Agents strains have been excluded from the regulation. This list of excluded Select Agents strains is posted at: http://www.selectagents.gov/Legislation.html.

    If the material (i.e., isolates or diagnostic/clinical samples) being used in the training event meets the exclusion criteria, then it is considered excluded from the regulation and therefore is not subject to the registration, transfer, record-keeping and other requirements of 42 CFR 73.

    If the entity will be using Select Agents or toxins in their training event, then current information regarding the entity, the principal investigator (PI) responsible for the Select Agents or toxins used in the training, and the laboratory rooms used in the training, must be on file with the National Select Agents Registry. If this information is not on file, then the entity should amend their application for registration.

    The RO should contact the entity's lead agency if they have questions on how to amend their application for registration with us.

    The RO from the entity will also need to submit the following information to the entity's lead agency at least 8 weeks prior to the training event:

    1. A summary of what type of training will occur, where it will occur and when it will occur. Include in your summary:
       1. Date of event,
       2. Building and laboratory room numbers where event will occur,
       3. Objectives of the training event (2-3 sentences)
    2. An updated Table 4B that lists personnel with authorized access, their affiliations and the specific agents that they will have access to at the entity that is sponsoring the training. These individuals will require approved security risk assessments from the FBI specific to the entity where training is conducted. See the Security Assessment section "What is the general process for obtaining a security risk assessment (SRA)" for additional details.
    3. A statement as to whether the participants will handle Select Agents during the training event. If participants will have direct access to Select Agents or toxins during the training, then provide their names with number 2, above.
    4. When the training event is over, the RO must provide NSAR with an update to remove authorized personnel from the entity registration.

    The entity should submit paperwork well in advance of the training event to ensure that a delay of the training will not occur.

    
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13. Where can I find information regarding security risk assessments?

    Please visit our Security Assessments page for information regarding security risk assessments.

    
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General Questions Regarding 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

1. 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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2. 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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3. 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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4. 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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5. 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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General Questions Concerning the National Select Agents Registry Website

1. 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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