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Select Agent (SA) Grams The Federal Select Agent Program communicates specific information to Responsible Officials of Select Agent registered entities through the use of emails (SA Grams) to assist entities with complying with the requirements of the Select Agent regulations. Additional Guidance Regarding Long Term Storage Posted on NSAR Website - 6/9/2011 Additional Guidance Regarding Long Term Storage Posted on NSAR Website - 6/9/2011The Federal Select Agent Program has updated the "Guidance on the Definition of Long Term Storage as Used in the Select Agent Regulations" to reflect the current policy regarding the regulatory status of tissue samples. The guide is available on the Select Agent Program website at: http://www.selectagents.gov/LongTermStorage.html. Return to topAfter-hours and Week-end Contact of Registered Entities during Natural Disasters - 3/12/2010This email is to notify you that either your file manager or Jae Brown, Emergency Response Specialist with the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT), may contact you if your area has been affected by a natural or man-made disaster or there is the potential of an imminent event. Depending upon the nature of the event, you may be contacted after normal business hours or on week-ends or holidays. The purpose of this contact is to verify that all select agents and toxins are properly secured and protected from theft, loss, or release and to determine if any assistance is needed. Return to topAnimals injected with or exposed to a select toxin - 4/19/2011Once an animal is injected with or exposed to a select toxin, does the animal need to be treated as a select toxin and housed in registered space? No. Once an animal has been injected with or exposed to (for example, by inhalation, dermal absorption, or ingestion) a select toxin, the animal would not be considered a "select toxin" and would not need to be housed in a registered space. Until the select toxin is injected into or exposed to the animal, the select toxin would be regulated under the Select Agent Regulations. This would include storage or use of the material (e.g., injection or exposure procedure). If select toxin is stored or used in the same area as the injected or exposed animal, the space will need to be listed on your entity's approved certificate of registration. The room where the injection or exposure procedures occur may be assessed using laboratory biosafety level criteria instead of animal biosafety level criteria. Note: The Federal requirements to register with the select agent program apply at any time the aggregate amount of a select toxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor exceeds the aggregate amounts specified (See 42 CFR §§ 73.3). For Botulinum neurotoxins, if the toxin preparation contains Botulinum neurotoxin producing strains of Clostridium, the animals will need to be treated as a select agent. This FAQ is available at www.selectagents.gov under the general FAQ tab. Return to topAnonymous reporting of safety and security issues associated with select agents and toxins - 4/26/2010The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs have 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.
The OIG Hotline information will also be available at: http://www.selectagents.gov/index.html. Return to topApplicability of the Select Agent Regulations to Issues of Synthetic Genomics and Definitions of Long Term Storage Document posted on NSAR Website. - 2/27/2009The APHIS and CDC Select Agent Programs are pleased to announce the public release of guidance regarding the application of the current select agent regulations to those who create and use synthetic genomic products and additional explanation for the term "long term storage" used in 42 C.F.R. Part 73.17 (1), 7 C.F.R. Part 331.17(1) and 9 C.F.R. Part 121.17(1). The guidance documents are available at: http://www.selectagents.gov/LongTermStorage.html. APHIS and CDC are committed to providing guidance to the regulated community for implementing the requirements of the Select Agent Regulations. In addition to this document, CDC and APHIS have developed other guidance materials including inspection checklists, interpretation guides, security plan templates, and inspection videos. These materials are also available on the NSAR website. Return to topAuthorization of individual’s access approval to select agents and toxins to be valid for a period of three years - 5/27/2011On January 9, 2009, President George W. Bush signed Executive Order (EO) 13486 entitled "Strengthening Laboratory Biosecurity in the United States." This EO established a Working Group (WG) co-chaired by the Secretary of Defense and the Secretary of Health and Human Services. The scope of WG activities pertained to the policy of the United States that facilities that possess biological select agents and toxins have appropriate security and personnel assurance practices to protect against theft, misuse, or diversion to unlawful activity of such agents and toxins. The WG provided final recommendations through careful consideration of proposals from subgroups and comments received from select agent entities and the public. The report is available at: http://orise.orau.gov/emi/scapa/files/biosecurity-report.pdf. One of the recommendations to enhance security was to perform the security risk assessment (SRA) required by the Select Agent Regulations (7 CFR § 331.10, 9 CFR § 121.10, 42 CFR § 73.10) every three years for all individuals with access to select agents and toxins instead of the current policy of performing the SRA every five years. The Federal Select Agent Program concurs with this recommendation. Beginning on June 1, 2011, Federal Select Agent Program approval of an individual's access to select agents and toxins, following a SRA by the Attorney General, will be valid for a maximum of three years. Please note: All individuals given approval to access select agents and toxins prior to June 1, 2011, will continue to have a five-year expiration date and will convert to the three-year renewal cycle upon renewal. The Select Agent Program has developed and posted the below frequently asked questions on the Select Agent Program website at: http://www.selectagents.gov/FAQ_SecurityRiskAssessments.html. How long is the SRA valid? An SRA for individuals that will have access to select agents and toxins is valid for a period not to exceed three years. APHIS or CDC can cancel approval at any time based on new information germane to the SRA. A registered entity can of course deny access to select agents and toxins to an individual at any time the entity determines that the individual no longer has a legitimate need to handle or use such agents and toxins. The RO, ARO, individuals that own or control an entity, and non-exempted entities must obtain SRA approval each time the certificate of registration is renewed. A certificate of registration is valid for a maximum of three years. Why did the policy change from access to select agents and toxins being valid for a period of five years to three years? On January 9, 2009, President George W. Bush signed Executive Order (EO) 13486 entitled "Strengthening Laboratory Biosecurity in the United States." This EO established a Working Group (WG) co-chaired by the Secretary of Defense and the Secretary of Health and Human Services. The scope of WG activities pertained to the policy of the United States that facilities that possess biological select agents and toxins have appropriate security and personnel assurance practices to protect against theft, misuse, or diversion to unlawful activity of such agents and toxins. The WG provided final recommendations through careful consideration of proposals from subgroups, and comments received from select agent entities and the public. The report is available at: http://orise.orau.gov/emi/scapa/files/biosecurity-report.pdf. One of the recommendations to enhance security was to perform an SRA required by the Select Agent Regulations (7 CFR § 331.10, 9 CFR § 121.10, 42 CFR § 73.10) every three years for all individuals with access to select agents and toxins instead of the current policy of performing the SRA every five years. The Federal Select Agent Program concurs with this recommendation. Who is affected by this new policy of access to select agents and toxins being valid for a period of three years? Effective June 1, 2011, individuals renewing SRAs will receive access approval to select agents and toxins for a period of three years unless terminated earlier by the entity, APHIS, or CDC. What is the process for the renewal request of an individual's SRA?
Avoiding Delays in Security Assessment Process - 11/14/2008The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs in collaboration with the FBI, Criminal Justice Information Services Division (CJIS) have been reviewing the Security Risk Assessment (SRA) Process. Through this review, we have identified some ways to avoid delays in this process:
General information on the security risk assessment process, including frequently asked questions and a link to the FD-961 form, is available at: http://www.selectagents.gov/sra.html. Return to topBotulinum neurotoxin producing species of Clostridium - 8/16/2011Botulinum toxin (serotypes A through G) is produced by Clostridium botulinum (phenotypically classified into 4 Groups -I, II, III, IV) and some isolates of Clostridium baratii (serotype F only), Clostridium butyricum (serotype E only), and Clostridium argentinense (serotype G only). Some strains of C. botulinum have been identified that produce 2 botulinum serotypes (e.g. both A and B). Demonstration of the production of botulinum neurotoxin, through a toxin detection test, in a suspect culture is critical to the characterization of a Botulinum neurotoxin producing species of Clostridium. Most isolates of C. baratii, C. butyricum, and some isolates of C. argentinense do not contain the genes necessary to produce botulinum toxin. Some non-toxigenic clostridia species (e.g. C. sporogenes) are phenotypically identical to C. botulinum but may result in an identification of C. botulinum on some rapid biochemical identification methods. If a laboratory detects botulinum neurotoxin from a culture of any suspected Clostridium species (such as C. botulinum, C. baratii, C. butyricum, and some isolates of C. argentinense), the laboratory will need to report the identification of Botulinum neurotoxin producing species of Clostridium by completing Section 1 of the APHIS/CDC Form 4 within seven calendar days of identification. In addition, if the laboratory is not registered with the Federal Select Agent Program for possession of Botulinum neurotoxin producing species of Clostridium, the laboratory must destroy or transfer the isolate within seven calendar days after identification. General information about reporting the identification of a Select Agent or Toxin including frequently asked questions are available at: http://www.selectagents.gov/FAQ_ReportingForm4.html. Return to topDefinition of variola virus in 18 U.S.C. 175c - 9/5/2008In December 2006, the National Science Advisory Board for Biosecurity (NSABB) presented a report to the U.S. Government entitled "Addressing Biosecurity Concerns Related to the Synthesis of Select Agents" (http://www.biosecurityboard.gov/links.asp). One of the recommendations in this report is a request for the repeal of 18 U.S.C. 175c. This statute deems it unlawful, unless authorized by the Secretary of Health and Human Services (HHS), to "knowingly produce, engineer, synthesize, acquire, transfer directly or indirectly, receive, possess, import, export, or use, or possess and threaten to use, variola virus," which is defined by that section of the United States Code to include "a virus that can cause human smallpox or any derivative of the variola major virus that contains more than 85% of the gene sequence of the variola major virus or the variola minor virus." Violations of 18 U.S.C. 175c are punishable by fines of up to $2,000,000 and imprisonment for 25 years to life. The NSABB was concerned that the definition of variola virus in 18 U.S.C. 175c could be interpreted to apply to other pox viruses (including vaccinia) which may have greater than 85% sequence homology with variola. Were that to be the case, NSABB was concerned that the application of such a broad interpretation could potentially have negative ramifications on vaccine development and other public health research. Given recent advances in the scientific understanding of the Variola genome, HHS requested that the Department of Justice (DOJ) clarify the scope of the definition of Variola contained in 18 U.S.C. 175c. The DOJ has recently completed its analysis of 18 U.S.C. 175c. In an Opinion signed on July 24, 2008 the DOJ concluded that the current definition of variola virus found in section 18 U.S.C. 175c applies only to viruses "produced, synthesized, or engineered from variola major virus or its components through human manipulation." Other non-variola orthopox viruses, such as cowpox, monkeypox, and vaccinia, are not included in the variola virus definition of 18 U.S.C. 175c. Please note that this Opinion does not affect the regulation of orthopox viruses listed as select agents in 42 C.F.R. part 73 and 9 C.F.R. part 121. Feel free to pass this information on to principal investigators or others in your institution who have an interest in orthopox virus research. If you have any questions on this Opinion, please contact the CDC Select Agent Program at 404-718-2000 or via email at lrsat@cdc.gov. Return to topDiscontinue previously used Bioterrorism Risk Assessment Fingerprint Card Package envelopes - 12/9/2010The FBI, Criminal Justice Information Services Division (CJIS) has requested that individuals discontinue using envelopes previously included in the Bioterrorism Risk Assessment Fingerprint Card Package that are addressed to Mail Processing. The following address is to be used to ensure the forms and fingerprint cards are directly delivered to the Bioterrorism Risk Assessment Group and prevent delays of 30 days or more. Bioterrorism Risk Assessment Group, Module E-3Criminal Justice Information Services Division 1000 Custer Hollow Road Clarksburg, WV 26306-0158 If you have any questions regarding this email, please contact CJIS at 304-625-4900. Return to topDSAT and APHIS Memorandum of Understanding with Department of Homeland Security, Office of Infrastructure Protection - 11/10/2008The APHIS and CDC Select Agent Programs have entered into a Memorandum of Understanding (MOU) with Department of Homeland Security, Office of Infrastructure Protection (IP) for information sharing. IP provides coordinated efforts to reduce the risk to our critical infrastructure and key resources posed by acts of terrorism, and strengthens national preparedness, timely response, and rapid recovery in the event of an attack, natural disaster, or other emergency. This MOU with IP allows for outreach to select agent registered entities regarding information sharing which may involve a visit by IP to your site to assist you in identifying vulnerabilities. Under this MOU, APHIS and CDC provided IP with your name, location, and the select agents or toxins registered for your entity. APHIS and CDC have regulatory authority over the select agent program, (including written security plans for information systems control), and IP is offering an opportunity to participate in this Infrastructure Protection program if you choose. We would recommend that if you do participate in this program your Incident Response Plans are updated to reflect this coordination effort. Return to topEntity's Termination of Individual's Access to Select Agents and Toxins - 10/17/2008Section 10(j) of the Select Agent Regulations (42 CFR 73, 7 CFR 331, and 9 CFR 121) requires that the Responsible Official immediately notify the Centers for Disease Control and Prevention (CDC) or the Animal and Plant Health Inspection Service (APHIS) when an entity is terminating an individual's access to select agents or toxins. The notification should include the name of the individual who is being removed from the entity's registration, the reasons for termination of access and should be submitted in writing via mail, fax, or email to your File Manager. When terminating an individual's access to select agents or toxins it is critical that the Responsible Official take steps to ensure that the individual no longer has the ability to access select agents or toxins. This may include retrieving keys, changing locks, disabling passwords, or disabling cardkeys. Guidance on restricting access to select agents and toxins and other information on the requirements of the Select Agent Regulations may be found on the National Select Agent Registry Web site at http://www.selectagents.gov/Resources.html. Return to topFederal Experts Security Advisory Panel’s Recommendations - 6/21/2011The Federal Experts Security Advisory Panel has published its recommendations made to the Secretaries of HHS and USDA related to security of the Biological select agents and toxins as defined in the select agent regulations. The report is available at: http://www.phe.gov/Preparedness/legal/boards/fesap/Documents/fesap-recommendations-101102.pdf. Return to topGuidance for the Inactivation of Select Agents and Toxins and Rendering Samples Free of Select Agents and Toxins - 12/14/2011The Federal Select Agent Program has developed and posted the "Guidance for the Inactivation of Select Agents and Toxins and Rendering Samples Free of Select Agents and Toxins." The guide is available on the Select Agent Program website at http://www.selectagents.gov/Guidance_for_the_Inactivation_of_Select_Agents_and_Toxins.html.If you have any questions regarding this email, please contact the Select Agent Program, for APHIS entities 301-851-3300 and for CDC 404-718-2000. Return to top Guidance on Containment for Work with Eastern Equine Encephalitis virus - 8/25/2011The Federal Select Agent Program is providing guidance on the containment facilities and practices that registered entities working with Eastern Equine Encephalitis virus (EEE) should follow. The guide is available on the Select Agent Program website at: http://www.selectagents.gov/Containment_for_Work_with_Eastern_Equine_Encephalitis_virus.html. Return to topGuidance regarding the identification of select agents and toxins posted on website - 8/19/2009The APHIS and CDC Select Agent Programs are pleased to announce the public release of the APHIS/CDC Form 4 guidance document. This guidance document is intended to provide detailed information and direction to clinical or diagnostic laboratories and other entities that have identified select agents and toxins contained in a specimen or sample presented for diagnosis, verification, or proficiency testing on how to complete all sections of APHIS/CDC Form 4. APHIS and CDC are committed to providing guidance to the regulated community for implementing the requirements of the Select Agent Regulations and for completion of APHIS/CDC forms. In addition to this document, APHIS and CDC have developed other guidance materials including inspection checklists, interpretation guides, security plan templates, and inspection videos. These materials are also available on the National Select Agent Registry (NSAR) website (www.selectagents.gov). Return to topGuidance regarding the transfer of select agents and toxins posted on website - 9/9/2009The APHIS and CDC Select Agent Programs are pleased to announce that answers to some of the most frequently asked questions (FAQs) regarding how to transfer a select agent or toxin and a guidance document providing detailed information and direction on how to complete all sections of APHIS/CDC Form 2 "Request to Transfer Select Agents or Toxins" are now available on the NSAR website at: Form 2 Guidance Document: http://www.selectagents.gov/TransferForm.html Transfer FAQs: http://www.selectagents.gov/FAQ_TransferForm2.html APHIS and CDC are committed to providing guidance and information to the regulated community for implementing the requirements of the Select Agent Regulations and for completion of APHIS/CDC forms. In addition to these documents, CDC and APHIS have developed other guidance and informational materials including inspection checklists, interpretation guides, security plan templates, and inspection videos. These materials are also available on the National Select Agent Registry (NSAR) website (www.selectagents.gov). Return to topGuidance regarding transferring identified select agents or toxins through diagnosis or verification posted on website - 12/16/2009The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs are providing clarification related to the shipment of select agents and toxins. Effective today, the Select Agent Programs will require prior authorization for any transfers that involve the transfer of select agent(s) for the purpose of susceptibility testing. The Select Agent Programs have developed the below FAQ that will be posted on the Select Agent Program website at: http://www.selectagents.gov/FAQ_ReportingForm4.html Question: Is the APHIS/CDC Form 2 required to transfer select agents identified from clinical/diagnostic specimens being sent to a registered laboratory for susceptibility testing? Answer: Yes, APHIS/CDC Form 2 is required to request prior authorization for the transfer of the identified select agent(s) for further guidance regarding requesting a transfer of a select agent or toxins, please refer to: http://www.selectagents.gov/TransferForm.html Return to topGuidelines for Avian Influenza Viruses - 11/16/2011The Agricultural Select Agent Program has prepared Guidelines for Avian Influenza Viruses (AIV) to assist individuals and entities develop policies and implement procedures for working safely with (AIV) in the laboratory. The guidelines provide a basic understanding of AIV as well as a baseline to meet the requirements of title 9, Code of Federal Regulations Parts 121 (Possession, Use, and Transfer of Select Agents and Toxins) and 122 (Organisms and Vectors). The guide is available on the Select Agent Program website at http://www.selectagents.gov/Guidelines_for_Avian_Influenza_Viruses.html Hand delivery of packages containing select agents and toxins - 4/1/2011The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs are providing clarification related to questions that we have received regarding hand delivery of packages containing select agents and toxins. The Select Agent Programs have developed and posted the below frequently asked questions on the Select Agent Program website at: http://www.selectagents.gov/FAQ_TransferForm2.html Are we required to use a commercial carrier for the domestic shipment within the United States of select agent shipments or can we hand deliver a package containing select agents or toxins to a registered recipient? The select agent regulations do not require the use of a commercial carrier for select agent shipments. However, even if an entity chooses to hand deliver a package containing a select agent or toxin to another registered entity it must still comply with section 16 (Transfers) and the transfer must be authorized by Select Agent Program. To initiate the transfer authorization, a CDC/APHIS Form 2 must be completed and sent to the Select Agent Program. In addition, the individual who is hand carrying the package must be SRA approved. The entity also remains responsible for ensuring that all local, state or federal transportation requirements for the transportation of hazardous materials are followed. [Note: If the entity moves the select agent or toxin "in commerce" using a common, contract, or private carriers, U.S. Department of Transportation hazardous materials regulations will apply.] The entity must ensure that adequate precautions are taken to prevent a theft, loss or release of the select agents and toxins. In addition, for animal or plant pathogens, interstate and certain intrastate movements will require a valid APHIS permit. Are we required to use a commercial carrier for importations of select agent shipments into the United States or can we hand deliver a package containing select agents or toxins to a registered recipient? Yes. The Select Agent Program, in order to ensure the security and safety of select agents, will not approve the importation of select agent material unless it is to be transported into the United States via a commercial carrier. An exception is for materials regulated under the U.S. Department of Agriculture's Plant Protection and Quarantine regulations (PPQ; 7 CFR Part 331) under certain conditions as described below. These materials may be hand-carried into the U.S. under the following conditions:
Policy on BMBL 5th edition Laboratory Facilities (Secondary Barriers) Standards - 8/5/2011
I. BSL-3/ABSL-3 Initial HVAC Verification Initial HVAC design verification must be performed and documented by someone with experience and expertise with the HVAC system prior to operation. This initial HVAC design verification ensures that secondary containment is maintained under failure conditions to prevent possible exposure of personnel outside the containment boundary. After HVAC verification is initially documented, the testing need not be repeated, providing no major changes have been made to, or major problems noted with, the HVAC system. See Section II below for details on major changes and major problems which may require repeat HVAC verification. Documentation must be provided of verification of HVAC design functionality under failure conditions. The failure conditions for verification include:
II. BSL-3/ABSL-3 Repeat HVAC Verification Once the BSL-3/ABSL-3 HVAC verification has been completed and approved by CDC/DSAT or APHIS/ASAP, HVAC failure conditions testing need not be repeated, providing there have been no major changes made to the HVAC system and no major problems noted with HVAC performance. Examples of major changes to the HVAC system which may require re-verification of HVAC design functionality under failure conditions by someone with experience and expertise with the system include: replacement of exhaust or supply fans that serve the BSL-3/ABSL-3 containment areas, replacement of ductwork valves or dampers that serve these areas, replacement or repair of HVAC system control wiring, building automation system logic programming changes, structural changes to the BSL-3/ABSL-3 rooms, or addition or removal of hard-ducted BSCs or fume hoods. Examples of major problems with HVAC performance that may require re-verification of HVAC design functionality under failure conditions include: frequent failures of the HVAC system, supply-exhaust interlocking system failure, observation that directional air flow is reversed under normal conditions, observation that HVAC alarms are not working, or that any BSCs with an HVAC connection are not working properly. III. Acceptance Criteria for HVAC Verification The documentation provided must demonstrate that under exhaust fan or normal power failure conditions, or during normal power start-up, there is no reversal of air which originates within the BSL-3/ABSL-3 laboratory or vivarium room that travels all of the way outside the containment boundary. A facility may be considered to pass the HVAC verification tests as long as laboratory air does not exit the containment barrier of the facility. The BSL-3 anteroom is considered to be within the containment envelope. A positive pressure excursion is not necessarily an airflow reversal; if a brief, weak positive pressure excursion is noted, a repeat test may be performed with airflow observation using an airflow indicator such as a smokestick, or dry ice in a container of water, at the base of the closed laboratory door to confirm whether airflow reversal is occurring. IV. BSL-3/ABSL-3 Initial Facility Verification and Annual Re-verification In addition to initial HVAC verification and re-verification as described above, the following are the minimum facility verification requirements that an entity is expected to perform and document initially for a BSL-3 or ABSL-3 laboratory and again at least annually. Some entities may choose to perform additional facility verification beside what is listed below.
Posting of Additional TLR Scenarios on NSAR - 6/15/2010The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs are pleased to provide additional guidance related to the Theft, Loss, or Release Reporting scenarios. An additional six (6) scenarios have been developed and the TLR document has been updated on the NSAR website at the following address: http://www.selectagents.gov/TLRForm.html Return to topPosting of Agents and Toxins Incident Response Plan - 6/3/2011The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs have developed and posted the "Select Agents and Toxins Incident Response Plan" guide to assist entities in developing the entity's incident response plan. The guide is available on the Select Agent Program website at http://www.selectagents.gov/Incident_Response_Plan.html Return to topPosting of Frequently Asked Questions Regarding Security Camera Surveillance - 12/8/2010The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs are providing clarification related to questions that we have received regarding security camera surveillance. The Select Agent Programs have developed and posted some frequently asked questions regarding security camera surveillance on the Select Agent Program website at http://www.selectagents.gov/FAQ_Security.html Return to topPosting OMB approved FD-961 form on website - 4/21/2010This email is to notify you that the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs have posted to the Select Agent Program website the OMB approved FD-961 form used by the FBI, Criminal Justice Information Services Division (CJIS) to evaluate an individual's suitability to access, possess, use, receive, or transfer select agents. The form is available at: http://www.selectagents.gov/sra.html Return to topProgress with Executive Order 13546: Optimizing the Security of Biological Select Agents and Toxins in the United States - 3/9/2011In the last several years, the Nation's biodefense research and development programs have expanded. This expansion has raised concerns in Congress and the public regarding safety and security in these new or expanded facilities. In addition, the revelation that the FBI's suspect in the Anthrax mail incidents of 2001 was a Federal laboratory scientist, coupled with recent reports of safety-related incidents that suggested a number of Select Agent Program registrants were not fully complying with the Select Agent Regulations have raised concerns in Congress and in the public. In recent years various scientific advisory groups, both Federal and private, have reviewed the current select agent program regulations and management and released reports providing recommendations for improvements. On July 2, 2010, President Obama signed "Executive Order 13546: Optimizing the Security of Biological Select Agents and Toxins in the United States" that directed the Department of Health and Human Services (HHS) and the Department of Agriculture (Agriculture) to review, tier, and consider the reduction of the Select Agent List; establish personal reliability standards for those having access to BSAT; and establish physical security standards for BSAT with the highest risk of misuse. The Executive Order is available at: http://edocket.access.gpo.gov/2010/pdf/2010-16864.pdf . The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs have been providing technical advice and administrative support to the Federal Experts Security Advisory Panel (FESAP), an interagency group created by the Executive Order to develop national recommendations for optimizing biosecurity. The FESAP provided its recommendations to the Secretaries of HHS, Agriculture, and the Attorney General on November 2, 2010. The FESAP recommendations addressed the reduction of the list of BSAT, the identification of a subset of the list that includes those BSAT whose misuse represents the most significant risks to public health and agriculture, and the improvement of security programs at registered entities. The CDC and APHIS Select Agent Programs have been working with our colleagues at the Department of Justice to evaluate these recommendations and implement as appropriate. We have initiated rulemaking activities and anticipate the publication of a Notice of Proposed Rulemaking sometime in the fall of 2011. One of our guiding principles in the drafting of new regulations is the theme, as expressed in the Executive Order, of providing for a harmonized, coordinated, and streamlined approach to securing BSAT in a manner that balances security with the need to meet important public health and critical biodefense requirements. In addition to supporting the work of the FESAP, the APHIS and CDC Select Agent Programs have convened an Interagency Working Group to execute Sections 6(a) and 8 of the Executive Order. This working group, which includes representatives from the Departments of Homeland Security, Defense, Justice, Energy, and the Environmental Protection Agency, is developing procedures and policies to better coordinate Federal inspections, information sharing, and other activities so that effective oversight can be achieved with a minimal disruption of critical biodefense functions. One outcome of this working group has been the initiation of a pilot joint inspection program between the APHIS and CDC Select Agent Programs and other federal agencies that fund or own entities where BSAT work is conducted to minimize the number of select agent inspections that these entities undergo per year. Return to topReporting incidents involving select agents and toxins - 4/1/2011The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs are providing clarification related to questions that we have received regarding reporting incidents involving select agents and toxins. The Select Agent Programs have developed and posted the below frequently asked questions on the Select Agent Program website at: http://www.selectagents.gov/FAQ_General.html#sec5q1 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 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.
Return to top Revised Renewal of Registration Requirements - 6/11/2009APHIS and CDC now require the submission of a complete, updated APHIS/CDC Form 1 (http://www.selectagents.gov/registrationForm.html) as part of the registration renewal process. This requirement will facilitate your entity's registration renewal and ensure that APHIS and CDC have the most current and accurate information. The Responsible Official will continue to receive notice of pending expiration of registration at least 180 days before the entity's registration expires. Therefore, we encourage entities to submit the complete, updated APHIS/CDC Form 1 as soon as they receive their renewal notice. To assist with the completion of the APHIS/CDC Form 1, APHIS and CDC are providing you with the Form 1 guidance document. This guidance document is intended to provide detailed information and direction to applicants and registered entities on how to complete all sections of APHIS/CDC Form 1 and on the submission of registration amendments. This document, along with the approved APHIS/CDC forms and tables are available on the NSAR website (www.selectagents.gov). Return to topSelect Agent Entity Information Sharing with State Public Health Preparedness Officials - 5/23/2008In recent years, the Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins (DSAT) has received requests for select agent entity information from state preparedness officials. Knowledge of the location of registered select agent entities could help states enhance their public health preparedness and response plans. Therefore, DSAT has established a plan whereby this information may be shared with appropriate state officials in a manner that can protect it from release to the public. Within the next week, DSAT will be sending a letter to the senior preparedness official in each state informing them that this information is available, provided that certain conditions are met. Since it is the current policy of DSAT to treat select agent information as "Sensitive But Unclassified," states must meet the following requirements prior to receiving the information:
In our initial contact with the states, we will also be providing them with guidance to assist with protecting this sensitive information to lessen the probability of unauthorized access to it. After a state submits the listed material, and DSAT's requirements are met, we will provide the following information:
You will receive notification from DSAT prior to this information being transmitted to the state. If you have any questions or concerns about this process, please contact Lori Bane at zoz1@cdc.gov or 404-718-2006. Return to topTheft, Loss, or Release Guidance Document Posted on NSAR Website - 2/27/2008The Centers for Disease Control and Prevention's (CDC) Select Agent Program is pleased to announce the public release of guidance to assist entities in complying with the requirements for notification of thefts, losses, or releases of select agents. This information document is the result of collaborative work between CDC and the Animal and Plant Health Inspection Service (APHIS). This document describes practices and procedures for submitting an APHIS/CDC Form 3, includes definitions of various terminology related to these types of events, and presents examples of scenarios for which submission of an APHIS/FORM 3 may be required. The theft, loss, or release guidance is available at: http://www.selectagents.gov/TLRForm.html CDC is committed to providing guidance to the regulated community for implementing the requirements of the Select Agent Regulations. In addition to the theft, loss, or release guidance document, CDC and APHIS have developed other guidance materials including inspection checklists, interpretation guides, security plan templates, and inspection videos. These materials are also available on the NSAR website. Return to topUpdate to the FBI's investigation - 1/7/2011The Federal Bureau of Investigation's Weapons of Mass Destruction Directorate, Operations Unit has informed Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs that they have no information that the situation that occurred yesterday with devices found in Maryland State buildings is related to select agents and toxins or entities working with select agents and toxins. However, if you receive a package from an unknown recipient, we request that you verify the address prior to attempting to open the package. If you cannot verify the address, we request that you follow your entity's security and incident response plans regarding receipt of a suspicious package. Return to top |
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