Source: http://www.selectagents.gov/SA_Gram.html
Timestamp: 2013-06-20 02:47:12
Document Index: 507012655

Matched Legal Cases: ['§ 73', 'art 73', 'art 331', 'art 121', '§ 331', '§ 121', '§ 73', '§ 331', '§ 121', '§ 73', 'art 73', 'art 121', 'arts 121', 'art 331', 'art 73', 'art 73', 'art 331', 'art 121', 'art 73', 'art 121', 'art 331', 'art 73', 'art 121', 'art 331', 'art 73', 'art 331', 'art 121', 'art 73', 'art 331', 'art 121', 'art 73', 'art 121', 'art 331']

Last Updated: Friday, May 03, 2013 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 After-hours and Week-end Contact of Registered Entities during Natural Disasters - 3/12/2010 Animals injected with or exposed to a select toxin - 4/19/2011 Anonymous reporting of safety and security issues associated with select agents and toxins - 4/26/2010 APHIS Permits - 12/14/2012
Applicability of the Select Agent Regulations to Issues of Synthetic Genomics and Definitions of Long Term Storage Document posted on NSAR Website - 2/27/2009
Applicability of the Select Agent Regulations to Issues of Synthetic Genomics Posted on NSAR Website - 12/17/2012
Authorization of individual�s access approval to select agents and toxins to be valid for a period of three years - 5/27/2011 Avoiding Delays in Security Assessment Process - 11/14/2008 Botulinum neurotoxin producing species of Clostridium - 8/16/2011 Definition of variola virus in 18 U.S.C. 175c - 9/5/2008 Discontinue previously used Bioterrorism Risk Assessment Fingerprint Card Package envelopes - 12/9/2010 DSAT and APHIS Memorandum of Understanding with Department of Homeland Security, Office of Infrastructure Protection - 11/10/2008
Elimination of http://www.selectagent.gov - 4/26/2012
Entity's Termination of Individual's Access to Select Agents and Toxins - 10/17/2008
Federal Experts Security Advisory Panel�s Recommendations - 6/21/2011
Guidance Documents - 10/30/2012
Guidance for the Inactivation of Select Agents and Toxins and Rendering Samples Free of Select Agents and Toxins - 12/14/2011
Guidance on Containment for Work with Eastern Equine Encephalitis virus - 8/25/2011
Guidance on the Use of Infectious Waste Treatment and Radiation Facilities - 4/27/2012
Guidance regarding the identification of select agents and toxins posted on website - 8/19/2009
Guidance regarding the transfer of select agents and toxins posted on website - 9/9/2009
Guidance regarding transferring identified select agents or toxins through diagnosis or verification posted on website - 12/16/2009
Guidelines for Avian Influenza Viruses - 11/16/2011
Hand delivery of packages containing select agents and toxins - 4/1/2011
Importation and Interstate Transport of Select Agents and Toxins - 3/26/2013
Policy on BMBL 5th edition Laboratory Facilities (Secondary Barriers) Standards - 8/5/2011
Posting of Additional TLR Scenarios on NSAR - 6/15/2010
Posting of Agents and Toxins Incident Response Plan - 6/3/2011
Posting of Frequently Asked Questions Regarding Security Camera Surveillance - 12/8/2010
Posting of Guidance for Completing the Shipper's Declaration for Dangerous Goods - 02/19/2013
Posting of SARS-CoV Recommendations - 2/5/2013
Posting OMB approved FD-961 form on website - 4/21/2010
Posting OMB approved FD-961 form on website - 1/11/13
Progress with Executive Order 13546: Optimizing the Security of Biological Select Agents and Toxins in the United States - 3/9/2011
Publication of Final Rules - 10/5/2012
Recent Publications by Federal Select Agent Program - 02/26/2013
Registration, Transfer, and Reporting of Select Agent Viral Genomic Material and Recombinant Nucleic Acids Encoding Functional Toxin - 9/12/2012
Reminder on Frequently Asked Question for reporting or identifying suspicious activity that may be criminal in nature concerning a registered entity, its personnel, or its select agents or toxins - 4/27/2012
Removal of select agents and toxins -10/22/2012
Reporting incidents involving select agents and toxins - 4/1/2011
Revised APHIS/CDC Form 1 Guidance Document and Strain Designation Information - 8/27/2012
Revised Renewal of Registration Requirements - 6/11/2009
Security Risk Assessment Tool - 12/7/2012
Select Agent Entity Information Sharing with State Public Health Preparedness Officials - 5/23/2008
Suitability Plan Template Document - 2/25/2013
Theft, Loss, or Release Guidance Document Posted on NSAR Website - 2/27/2008
Tier 1 Select Agents and Toxins - 10/17/2012
Update to the FBI's investigation - 1/7/2011
USDA, APHIS Select Agent Program new telephone number and email address - 4/13/2012
Use of "Lost in the crowd" concept for shipping select agent and toxin - 03/15/2013
Verifying Inspectors and Confidentially Agreement Policy - 7/19/2012
Additional Guidance Regarding Long Term Storage Posted on NSAR Website - 6/9/2011
The 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.
After-hours and Week-end Contact of Registered Entities during Natural Disasters - 3/12/2010
This 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 top
Animals injected with or exposed to a select toxin - 4/19/2011
Once 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 top
Anonymous reporting of safety and security issues associated with select agents and toxins - 4/26/2010
The 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. Voice:
HHSTips@oig.hhs.gov Web:
Mail: Office of Inspector General Department of Health & Human Services Attn: Hotline P.O. Box 23489 Washington, DC 20026
The OIG Hotline information will also be available at: http://www.selectagents.gov/index.html.
APHIS Permits - 12/14/2012
In the past, Animal and Plant Health Inspection Service (APHIS) has required that entities be registered with the Federal Select Agent Program when receiving proficiency test samples which could potentially contain overlap or USDA select agents. Effective immediately, based on the exemptions contained in 9 CFR 121.5 and 121.6, 7 CFR 331.5 and 331.6, APHIS will no longer require entities which are receiving samples for diagnosis, verification or proficiency testing to be registered provided they meet the requirements of the select agent regulations to secure any select agents or toxins identified, transfer or destroy the material in the appropriate time frame, report the identification of the material to Federal Select Agent Program, and maintain records for three years.
Entities will still need APHIS permits to receive samples for diagnostic, verification or proficiency testing which could potentially contain animal or plant pathogens. Entities should indicate on their permit application that the request is to receive samples that may contain select agents submitted for diagnosis, verification, or proficiency testing. The permit will be issued with restrictions related to diagnosis, verification, or proficiency testing.
The 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 top
The Federal Select Agent Program is 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. The guidance documents are available at: http://www.selectagents.gov/Resources.html#compliance.
Authorization of individual's access approval to select agents and toxins to be valid for a period of three years - 5/27/2011
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 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? APHIS or CDC will provide the RO with a list of individuals who need renewed SRAs and details regarding the SRA renewal process. Note: It is the RO's responsibility to ensure all individuals listed on the entity's registration are SRA approved. No less than 45 days prior to their expiration date, any individual identified for SRA renewal should submit a new FD-961 Form to CJIS by faxing to 304-625-2198. Fingerprint cards are not required for the renewal process. However, CJIS reserves the right to request additional fingerprint cards if necessary. APHIS or CDC will notify the RO in writing the results of the individual's SRA. Return to top
Avoiding Delays in Security Assessment Process - 11/14/2008
The 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: Prior to submitting a request to add a new individual to the entity's registration, first obtain the completed FD-961 and fingerprints from the individual. After you have these documents in your possession, then request to add the individual to your entity's registration. We recommend sending the signed original SRA application materials (e.g., FD-961 form and/or fingerprint cards) to CJIS by way of a traceable carrier (e.g., FedEx, UPS). For SRA renewals, the completed FD-961 form should be faxed to CJIS at 304-625-5393. Please write the word "Renewal" on top of the form because this alerts CJIS that this individual has already been through the SRA process. A new DOJ unique identifier number will not be assigned to individuals for renewal SRA requests as long as the individual stays employed with the current registered entity. Fingerprint cards are not required for the renewal process, since they are already on file with CJIS; however, CJIS reserves the right to request additional fingerprint cards in the future if necessary. 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 top
Botulinum neurotoxin producing species of Clostridium - 8/16/2011
Botulinum 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.
Definition of variola virus in 18 U.S.C. 175c - 9/5/2008
In 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 top
Discontinue previously used Bioterrorism Risk Assessment Fingerprint Card Package envelopes - 12/9/2010
The 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-3 Criminal 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 top
DSAT and APHIS Memorandum of Understanding with Department of Homeland Security, Office of Infrastructure Protection - 11/10/2008
The 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 top
Since 2009, the National Select Agent Registry website has been available at both http://www.selectagent.gov and http://www.selectagents.gov. Effective May 1st 2012, the http://www.selectagent.gov web address will no longer be available and its presence will be eliminated from the World Wide Web. Please remove or update any personal links, bookmarks or favorites you may have saved for this site. To access the Federal Select Agent Program, you will need to use the following website link http://www.selectagents.gov/.
The elimination of the http://www.selectagent.gov website directly supports the President�s Executive Order 13571 and the .gov reform effort which requires federal agencies to take specific steps to strengthen customer service, including how they deliver services and information on federal ".gov" websites. The .gov reform effort is part of President Obama's Campaign to Cut Waste, identifying unnecessary websites that can be consolidated into other websites to reduce costs and improve the quality of service to the American public.
Section 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.
The 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.
The Federal Select Agent Program has developed the following guidance to assist entities with meeting the required elements of the new regulations published on October 5, 2012: Guidance on the Shipment and Receipt of Packages with Select Agents and Toxins
Toxin Due Diligence Provision
The guidance can be found at: http://www.selectagents.gov/Resources.html.
The 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 (option 1) and for CDC 404-718-2000.
The 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.
The Federal Select Agent Program has developed and posted the "Guidance on the Use of Infectious Waste Treatment and Radiation Facilities Outside of Registered Space." The guide is available on the Select Agent Program website at http://www.selectagents.gov/Guidance_on_the_Use_of_Infectious_Waste_Treatment.html.
The 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 top
The 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 top
The 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
The 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
If you have any questions regarding this email, please contact APHIS at 301-851-3300 (option 1). Return to top
The 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: A request to hand-carry must be in writing including detailed reasons for the need to hand carry vs. commercial carrier, person's passport number, travel locations, date and times of itinerary; date, time, airline, arriving flight number, and first location of U.S.-landing must be supplied and in advance of the proposed foreign travel. The need for hand-carrying is considered extraordinary (i.e. not the convenience of the person).
The requestor must be a Federal employee who is a United States resident, be SRA-approved, and have at least a secret-level clearance.
Agriculture Select Agent Program writes a courier letter to the Custom and Border Patrol (CBP) workstation at the first U.S. port of entry. The letter details the individual, trip itinerary, the carrying of "biological material" (not the exact name) that is permitted by Animal and Plant Health Inspection Service (APHIS), the date, time, flight #, departing and arriving cities, the final destination of the person, and requests that CBP and Immigration expedite the individual through Customs as they are on official travel for the U.S. Government. This letter is sent through Department of Homeland Security (DHS), CBP channels for delivery to the workstation. The individual is required to carry a copy of this letter with their travel documents and to show it upon CBP request.
On February 4, 2013, the Centers for Disease Control and Prevention (CDC) within the U.S. Departments of Health and Human Services (HHS) published a final rule to improve CDC's ability to prevent the introduction, transmission, or spread of communicable diseases into the United States. A web link to the Federal Register Notice can be found at http://www.cdc.gov/od/eaipp/. The final rule which is effective April 5, 2013 contains a provision that a CDC import permit is not required for an item if it is a select agent or toxin listed in 42 CFR Part 73.3 and 73.4 and its importation has been authorized in accordance with 42 CFR 73.16 or 9 CFR 121.16. The U.S. Department of Agriculture (USDA)'s Animal and Plant Health Inspection Service has determined that a permit is not required from Veterinary Service's National Center for Import and Export for the importation or interstate movement of a select agent listed in 9 CFR 121.3 and 121.4 provided that the importation and interstate movement of these select agents and toxins are authorized for transfer in accordance with 42 CFR 73.16 or 9 CFR 121.16.
BSL-3 D9: "The laboratory shall be designed such that under failure conditions the airflow will not be reversed."
ABSL-3 D6: "The ABSL-3 animal facility shall be designed such that under failure conditions the airflow will not be reversed."
BSL-3 D15: "The BSL-3 facility design, operational parameters and procedures must be verified and documented prior to operation. Facilities must be re-verified and documented at least annually."
ABSL-3 D14: "The ABSL-3 facility design and operational procedures must be documented. The facility must be tested to verify that the design and operational parameters have been met prior to use. Facilities should be re-verified at least annually against these procedures as modified by operational experience."
The Federal Select Agent Program Policy is based on the above BMBL Standards as currently published and is subject to change. Current policy: 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: Mechanical failure of exhaust fan or fan component(s):
If redundant fans are present, the ability to transition to the alternate fan without reversal of air flow from potentially contaminated laboratory space into "clean" areas surrounding the laboratory must be verified.
If no redundancy is present in the laboratory HVAC system, the capacity to transition from sustained inward air flow into the laboratory to a "static" condition, i.e., no air flow out of the laboratory must be verified.
If emergency power supply is available for the laboratory HVAC system, the ability to transition from "normal" power to the backup system without a reversal of air flow from the laboratory should be verified.
If no backup power supply is available, the ability of the HVAC system to transition to a "static" condition, i.e., no outward air flow, should be verified.
Return from power failure to "normal" operating conditions:
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. The means of detecting air flow (tell tale, magnehelic or digital gauge, Baulin-Tube®, etc.) has been confirmed to accurately reflect observed air flow. It is recommended, but not required, that digital or magnehelic gauges be calibrated annually.
If a Building Automation System has the capacity to monitor and record performance measurements, e.g., differential pressures, the entity is encouraged to capture and store data from potential failure events, drills, etc. This information may provide verification of system performance. In addition, any programmed BAS alarms should be verified for proper functioning.
The 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
The 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 top
The 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 top
The Federal Select Agent Program is pleased to announce the availability of "Guidance for Completing the Shipper�s Declaration for Dangerous Goods" at: http://www.selectagents.gov/Resources.html.
The Federal Select Agent Program is pleased to announce the availability of "Recommendation of Guidelines for Medical Surveillance of Laboratory Personnel Working with SARS-CoV" and "Recommendations in Clinical Guidance on the Identification and Evaluation of Possible SARS-CoV Disease among Persons Presenting with Community-Acquired Illness" at: http://www.selectagents.gov/Resources.html.
This 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 top
This email is to notify you that the Federal Select Agent Program has posted to the Select Agent Program website the link to OMB approved FD-961 form. The FD-961 form is used by the Federal Bureau of Investigation, Criminal Justice Information Services (CJIS) Division to conduct a security risk assessment for those individuals and entities that wish to register with the Federal Select Agent Program or those individuals needing approval to have access to select agents and toxins. The link to the form is available at: http://www.selectagents.gov/sra.html. After January 24, 2013, CJIS will only be accepting the OMB approved FD-961 form (OMB No. 1110-0039; expiration date 5/31/2014). The use of an expired form after January 24, 2013 will result in return of the form to the submitter and a delay in the processing of an individual�s security risk assessment (SRA).
In 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 top
The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121) in the Federal Register on October 05, 2012 . All provisions of the final rules supersede those contained in the previous final rules.
The table below describes the effective dates:
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, 16, 17, 18, 19, 20, and 21
11, 12, 14, and 15
Three viruses have been added to the select agent list: severe acute respiratory syndrome (SARS)-associated coronavirus, Lujo and Chapare viruses. File managers will be contacting those affected entities.
The select agents and toxins that were removed from the list are:
Cercophithecine herpesvirus 1 (herpes B virus)
All Conotoxins except those designated as short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7
Eastern equine encephalitis virus (South American type only)
West African clade of Monkeypox viruses
Shigatoxins and Shiga-like ribosome inactivating proteins
All Staphylococcal Enterotoxins except subtypes A, B, C, D, and E
Tick-borne encephalitis complex viruses (Central European subtype)
A new designation, "Tier 1", has been developed for those select agents and toxins considered being of the greatest risk for deliberate misuse and the most significant potential for mass casualties, or devastating effects on the economy or critical infrastructure. The agents and toxins designated as Tier 1 select agents and toxins are:
Bacillus anthracis (excluding Pasteur strain)
The new requirements for registered entities working with Tier 1 agents include enhanced physical security standards, suitability assessments of lab workers before they can work with Tier 1 agents, and ongoing monitoring of personnel with access to agents or toxins on the Tier 1 list.
Please make sure to read the Final Rules, which are available at http://www.selectagents.gov/ to ensure you are aware of all the changes with these regulations.
Additional information will be provided prior to parts of the rule becoming effective to assist you with compliance with the select agent regulations.
For your information, the Federal Select Agent Program has recently published the following articles in Applied Biosafety and Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science:
"Establishing a National Biological Laboratory Safety and Security Monitoring Program" Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, Vol. 10(4), pp. 396-400, 2012. "Monitoring Select Agent Theft, Loss and Release Reports in the United States-2004·2010" Applied Biosafety, Vol. 17(4), pp. 171-180, 2012.
The articles can be found at: http://www.selectagents.gov/Publications.html.
The select agent regulations provide that the following genetic elements, recombinant nucleic acids and genetically modified organisms are select agents (See section 3(c) of 42 C.F.R Part 73, 9 C.F.R Part 121, and 7 C.F.R Part 331):
APHIS/CDC Form 1, Form 2, Form 3 and Form 4 have been revised to address the regulation status of nucleic acids encoding certain Select Agent viral genomes and recombinant nucleic acids that encode for the functional form of select toxin(s). Entities must register for the possession and use of these regulated nucleic acids using APHIS/CDC Form 1, and use APHIS/CDC Form 2 for any transfers involving these agents. Entities must report the theft or loss of the regulated nucleic acids using APHIS/CDC Form 3, and any identification on APHIS/CDC Form 4. Note: If you do not possess extracted and isolated nucleic acids that meet the above requirements, no change to your registration is required at this time. The registration of intact, live agent is sufficient to cover the genomic material in that agent as long as it is not extracted and isolated for further testing or research purposes. Entities that currently possess or use these regulated nucleic acids are reminded that they must ensure that they have an accurate and current inventory of these materials held in long term storage. Please refer to http://www.selectagents.gov/SyntheticGenomics.html for additional guidance on these regulated nucleic acids. Possession, use or transfer of these regulated nucleic acids will require prior approval by the Federal Select Agent Program. The deliberate formation of recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD50 < 100 ng/kg body weight is a restricted experiment as defined in 42 C.F.R. 73.13(b)(2). Further, recombinant nucleic acids that encode functional forms(s) of select toxins meet these criteria and are also regulated. Functional forms could represent subunits of the toxin-encoding gene of any length that encode for products that have a deleterious biological effect lethal for vertebrates at an LD50 < 100 ng/kg body weight. Lack of biological effect should not be assumed. Experimental data from a recognized biological model (either in vivo or in vitro) of toxin activity should be submitted to Federal Select Agent Program for consideration before recombinant nucleic acids that encode for regulated toxin can be excluded from regulation. Restricted experiments as defined in section 13 of 42 C.F.R Part 73, 9 C.F.R Part 121, and 7 C.F.R Part 331) require review by the Federal Select Agent Program before conducting the experiment. Please refer to http://www.selectagents.gov/LongTermStorage.html for additional guidance for the accurate, current inventory of select agent material, including regulated nucleic acids, held in long term storage. Return to top
The Federal Bureau of Investigation�s Weapons of Mass Destruction Directorate (WMD), Operations Unit has informed Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) Select Agent Programs that a company has contacted a registered entity in an attempt to sell a "select agent inventory management program." The unsolicited email is of concern since a private company had identified a registered entity and specific individuals with approved access to select agents or toxins within the facility. The report came from a WMD Coordinator who received the information from an entity regarding the suspicious activity.
The Federal Select Agent Program is reminding you that we have developed and posted the below frequently asked question on the Select Agent Program website at: http://www.selectagents.gov/FAQ_General.html.
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.
On October 5, 2012, the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules amending the regulations that govern the possession, use, and transfer of select agents and toxins (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121). One of the changes, effective December 4, 2012, was the deletion of the following agents and toxins from the select agents and toxins lists: Akabane virus, Bluetongue virus (exotic), Bovine spongiform encephalopathy agent, Camel pox virus, Cercophithecine herpesvirus 1 (herpes B virus), Clostridium perfringens epsilon toxin, Coccidioides posadasii/Coccidioides immitis, all Conotoxins except those designated as short, paralytic alpha conotoxins, as defined in the regulations, Eastern equine encephalitis virus (South American type only), Ehrlichia ruminantium (Heartwater), Flexal virus, Japanese encephalitis virus, Malignant catarrhal fever virus (Alcelaphine herpesvirus type 1), Menangle virus, West African clade of Monkeypox viruses, Rickettsia rickettsii, Shigatoxins and Shiga-like ribosome inactivating proteins, all Staphylococcal Enterotoxins except subtypes A, B, C, D, and E, Tick-borne encephalitis complex viruses (Central European subtype), any subtypes of Venezuelan equine encephalitis virus except for Subtypes IAB or IC, Vesicular stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3, and Xylella fastidiosa (citrus variegated chlorosis strain). Prior to December 4, 2012, the Federal Select Agent Program (APHIS or CDC) requests that you submit an amendment requesting to: (1) remove laboratory/storage room(s) and personnel currently registered only for select agent(s) and toxin(s) being deleted from the list (cover letter will suffice); or (2) add a select agent(s) or toxin(s) for these laboratory/storage room(s) and indicate the personnel that will need to have access. Depending upon the action taken, the amendment should contain the updated following sections of the APHIS/CDC Form 1: section 3, section 4, section 5 (if applicable), and section 6. To assist you with this process, the APHIS/CDC Form1 Guidance Document is available at: http://www.selectagents.gov/RegistrationForm.html. It is important to remember that the select agents removed from the list may have specific APHIS permit requirements for domestic movement or importation that will remain in effect. Return to top
The 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. Voice:
The Federal Select Agent Program is pleased to announce the public release of detailed information for the submission of registration application and amendments. We have also updated the guidance to provide for the designation of select agent and toxin strain(s) or type(s) on APHIS/CDC Form 1, Section 6. It is recommended that entities submit updated select agent strain or toxin type designations as described in the attached APHIS/CDC Form 1 guidance document. The APHIS/CDC Form 1 Guidance Document, along with the approved APHIS/CDC forms and tables, are available at: http://www.selectagents.gov/RegistrationForm.html.
APHIS 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 top
The Federal Select Agent Program website (www.selectagents.gov) has posted a link to the BioRAM security risk assessment tool. This tool has been developed by Sandia National Laboratories as a standardized method for performing entity-specific risk assessments. This tool is an option for entities to use in performing site specific risk assessment as they develop their security plans.
In 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: Provide DSAT with the state's plan for using the information for public health preparedness planning.
Provide DSAT with the state's policies and procedures for safeguarding the information from unauthorized access or release. The proposed custodian of the information must sign an agreement limiting the sharing of information. Provide DSAT with a written legal opinion from their state's legal counsel stating that the information provided can be protected from further release under the applicable State Freedom of Information laws.
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: Name and location of registered entities within that state.
Name and contact information for Responsible Officials of registered entities within that state.
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 top
The Federal Select Agent Program has developed Suitability Plan Template to assist entities with meeting the required elements of the new regulations published on October 5, 2012. The template document can be found at: http://www.selectagents.gov/Guidance_for_Suitability_Assessments.html.
The 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 top
On October 5, 2012, the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) published final rules amending the regulations that govern the possession, use, and transfer of select agents and toxins (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121). One of the changes, effective December 4, 2012, was the designation of the following agents and toxin as Tier 1: Botulinum neurotoxin, Toxin-producing strains of Clostridium botulinum, Bacillus anthracis (excluding Pasteur strain which remains a select agent), Burkholderia mallei, Burkholderia pseudomallei, Ebola virus, Foot-and-mouth disease virus, Francisella tularensis , Marburg virus, Rinderpest virus, Variola major virus, Variola minor virus, and Yersinia pestis.
If your entity is registered for the above agents or toxins, you must meet additional security (Section 11), biosafety (Section 12), incident response (Section 14), and training (Section 15) requirements for Tier 1 agents by April 3, 2013. To assist you in the understanding of these additional requirements, guidance documents are available at: http://www.selectagents.gov/.
If your entity possesses only non-Tier 1 agents (i.e., Bacillus anthracis (Pasteur strain)), or excluded strains (http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Exclusions.html), and does not wish to remain registered for Tier 1 select agents and/or toxins, you will need to submit an amendment to your entity's registration by completing the appropriate sections of APHIS/CDC Form 1.
To assist you with this process, the APHIS/CDC Form1 Guidance Document is available at: http://www.selectagents.gov/RegistrationForm.html. Please be reminded your entity will not be able to retain Tier 1select agents or toxins identified from clinical or diagnostic samples longer than seven days after identification, or select agents or toxins identified from proficiency testing samples longer than 90 days after receipt, (Sections 5 and 6), if you remove these from your entity's registration.
The 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
As of April 2, 2012, USDA APHIS Select Agent Program has a new telephone number and email address. The new telephone number is 301-851-3300 (option 1) and the new email address is ASAP@aphis.usda.gov. Please note that http://www.selectagents.gov/ is in the process of being updated to reflect this change.
The Federal Select Agent Program (FSAP) has amended the select agent regulations so regulated entities that maintain shipping and receiving facilities, and have procedures that are able to maintain select agent and toxin anonymity in shipping/receiving facilities, i.e., preserving "lost in the crowd," will not be required to register these areas if packages containing select agents or toxins will temporarily be stored in these areas awaiting transportation pickup. For entities preserving the "lost in the crowd" concept during shipping and receiving, the select agent regulatory oversight for recipients begins when a select agent or toxin package arrives at its ultimate destination for unpacking by an individual approved for access by the Department of Health and Human Services (HHS) Secretary or Animal and Plant Health Inspection Service (APHIS) Administrator. Select agent and toxin oversight for senders covers all use of a select agent and toxin up to the time that the materials are packaged for shipment, in compliance with Department of Transportation (DOT) hazardous materials regulations, by an individual approved for access by the HHS Secretary or APHIS Administrator. If packages are labeled as containing "Suspected Category A infectious substances" and temporarily stored in the shipping/receiving area, there is no need to develop and implement security practices (e.g., securing packages, registering the shipping/receiving area, and meeting Tier 1 requirements) for the area as the "lost in the crowd" concept is being preserved. The FSAP approves and DOT recommends the use of "lost in the crowd" for all shipments of a select agent and toxin. To comply with this approach, "suspected Category A infectious substance" can be used as the technical name on the Shipper�s Declaration of Dangerous Goods in-lieu of identifying the select agent in the technical name, such as by listing the specific genus and species. Note: the technical name is included in parenthesis after the proper shipping name in the "Proper Shipping Name" section of the form. This approach will assist in maintaining anonymity for select agent and toxin packages during transit and avert additional security risks for couriers. Also, the technical name should not be placed on the package itself; instead the area for the technical name should be left blank. In collaboration with DOT, the FSAP has developed guidance for the regulated community on the packaging and shipping of select agents and toxins. This guidance is available at http://www.selectagents.gov/FAQ_TransferForm2.html and includes information on all applicable domestic and international shipping regulations. Return to top
The Federal Select Agent Program would like to make you aware of our policy for verifying Federal Select Agent Program Inspectors and an entity's request to sign a confidentially agreement. The Federal Select Agent Program Inspectors have statutory authority (Public Health Security and Bioterrorism Preparedness and Response Act, 2002) to enter an entity in possession of biological select agents in toxins to perform inspections related to compliance with the HHS and USDA Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331). A Federal Select Agent Program Inspector may show an entity his/her official government badge. The official government badge consists of the employee's name, picture of the employee, the individual's personal identifier number, and the government agency that the employee is affiliated. All Federal Select Agent Program Inspectors have undergone appropriate Federal background investigations and adhere to Federal Select Agent Program policy's for safeguarding select agent information. The Federal Select Agent Program Inspector is not allowed to give the entity his/her official government badge in exchange for the entity's identification badge. In addition, the entity is not allowed to copy the badge. The Federal Select Agent Program Inspector will not provide the entity with any personal identification such as driver's license, social security card, etc. The entity may request for the Federal Select Agent Program to provide the entity with an "Inspector Verification" letter prior to the arrival of the inspectors. However, a request for a "Inspector Verification" letter, or the absence of an "Inspector Verification" letter may not be used as grounds for delaying the start of an inspection. The Federal Select Agent Program Inspector is not authorized to and may not sign a confidentiality agreement connected in any way to their duties as an inspector for the Federal Select Agent Program. Return to top