In response to a recent request, the Federal Select Agent Program has posted to its website a new regulatory interpretation regarding requirements for annual refresher training as it relates to the provisions of the select agent regulations.
2016 SA Grams
The Federal Select Agent Program (FSAP) has rescheduled its webcast – originally scheduled for November 9 – to February 8, 2017 from 12:00 PM to 4:00 PM EST. A notice in the Federal Register, as well as more information on the agenda, will be forthcoming. Participants can continue to register here.
Participants that have already registered for the November date will not need to re-submit registration requests for the new date. If you have any questions regarding this webcast, please contact the FSAP via CDC (Diane Martin, firstname.lastname@example.org) or APHIS (Leon White, AgSAS@usda.gov).
In response to the difficulties that entities are currently facing in shipping select agents and toxins, the Federal Select Agent Program (FSAP) has issued a new policy to help entities meet the requirements for possession and transfer of select agents and toxins once these materials are newly identified from diagnostic or verification testing.
A draft of this policy was previously shared with the regulated community for feedback. No changes have been made to the contents of the policy, although FSAP has clarified in the policy title that this policy specifically applies to exemptions required due to shipping difficulties.
Key elements of the policy include:
- The new policy allows for a clinical, diagnostic laboratory or other entity that possesses a select agent or toxin contained in a specimen presented for diagnosis or verification to extend their time of possession of that select agent or toxin up to 28 calendar days after identification. This will allow these entities adequate time to transfer the identified select agent or toxin to a registered entity (normally required to be within seven calendar days after identification).
- To obtain this extension, a written request must accompany the submission of an APHIS/CDC Form 4 (Report of the Identification of a Select Agent or Toxin). The written extension of time request must describe why the select agent or toxin should be transferred rather than destroyed, the difficulty an entity is facing in shipping a select agent or toxin, confirm that no additional work will be performed with the material containing the select agent or toxin, and provide a detailed description of how the select agent or toxin material will be secured until the select agent or toxin is transferred.
Today, the Federal Select Agent Program (FSAP) has issued a revised policy statement regarding the inactivation of Bacillus anthracis. The new policy reflects the recent addition of Bacillus cereus biovar anthracis to the list of HHS Tier 1 select agents and toxins and also includes a number of changes to improve clarity.
The revised policy replaces the previous FSAP policy statement on the subject (issued June 29, 2016). All elements of the revised policy take effect immediately with the exception of #7 below, which takes effect on October 14, 2016, as this is the effective date that B. cereus biovar anthracis will be considered a select agent. The policy is attached to this email and will be posted online at http://www.selectagents.gov/regulations/policy/bacillus.htm. Key changes are as follows:
- Clarifies that the policy is applicable to Bacillus anthracis Pasteur strain.
- Updates the definition of safety margin.
- Removes the requirement for statistically defensible inactivation criteria until guidance can be provided.
- Clarifies the neutralization step for chemically inactivated material (2c).
- Clarifies the sample volume sections to include procedures for large volume cultures.
- Clarifies the records section to include initial validation data.
- Includes the recently added HHS Tier 1 select agent B. cereus biovar anthracis.
Additional information regarding this revised policy is available at: http://www.selectagents.gov/compliance/faq/bacillus.htm.
If you have any questions regarding this email, please contact 301-851-2070 for APHIS/AgSAS entities, and 404-718-2000 or DSATScienceoffice@cdc.gov for CDC/DSAT entities.
The Federal Select Agent Program has posted additional Frequently Asked Questions (FAQs) to its website in order to clarify requirements related to the revisions made to the June 29, 2016 policy statement addressing the inactivation of Bacillus anthracis.
The new FAQs are posted online at http://www.selectagents.gov/compliance/faq/bacillus.htm. No changes have been made to the policy itself. The existing FAQs (numbers 1-14) were edited for clarity and new FAQs (numbers 15-22) were added.
Today, CDC published an Interim Final Rule adding B. cereus Biovar anthracis to the list of HHS select agents and toxins to be regulated as a Tier 1 agent. The regulation, available at https://www.federalregister.gov/d/2016-22049external icon, was published in the Federal Register and CDC will be accepting public comment on the addition of the agent for the next 60 days.
B. cereus Biovar anthracis is an emerging pathogen that has properties very similar to Bacillus anthracis (which is currently regulated as a Tier 1 agent). The agent has been isolated from great apes with anthrax-like disease in several countries in Africa.
This Interim Final Rule amends the HHS list of select agents and toxins, while simultaneously undertaking a public comment period. Given the potential for safety and security concerns due to its similarities to Bacillus anthracis, CDC believes that it is important to regulate this agent now while it appears to be limited in distribution.
Once the 60-day public comment period has closed, CDC will consider the comments received and then publish a Final Rule. In the meantime:
- Within 30 days of publication of the notice in the Federal Register, any individual or entity that possesses B. cereus Biovar anthracis must provide notice to CDC regarding their possession of this agent.
- By 180 days after the publication date, any individual or entity that intends to continue to possess, use, or transfer this agent will be required to either register in accordance with the select agent regulations (42 C.F.R. part 73) or amend their current registration and meet all of the requirements of the select agent regulations.
Comments on the regulations should be submitted via the regulations.gov website; a direct link is available hereexternal icon.
As a part of the Federal Select Agent Program (FSAP)’s efforts to increase the quality and consistency of inspections, we have developed several initiatives and requested comments and input from the regulated community. FSAP thanks everyone who provided feedback to the opportunity to comment on severity of inspection departures, enforcement actions, and sample report cards sent June 21, 2016. Many were supportive of the approach and appreciative of our efforts to better explain inspection findings and their significance.
Comments generally fell into the following categories:
- Entities seeking general clarification of information.
- The look and feel of the information as presented in the report cards.
- Whether the information will be protected from release to the public.
- General program recommendations for improvement.
We received one comment regarding severity scoring for departures. The commenter suggested moving the example of “Systemic failure to provide refresher training to FSAP-approved individuals or training to visitors” from a serious severity level to a moderate severity level. We agree that failure to provide refresher training may not itself be a serious departure. The statement will be revised to “Systemic failure to provide training to FSAP-approved individuals or training to visitors on a consistent basis.” FSAP believes that a systemic failure to provide training to FSAP-approved individuals or training to visitors on a consistent basis indicates widespread failure to implement training requirements and to ensure staff and visitors are familiar with and capable of complying with an entity’s biosafety, security, and incidence response plans. We want to convey the belief that at some level the failure of an entity to meet the regulatory training requirements could be considered a serious departure.
Based on comments received on the report card, CDC’s Division of Select Agents and Toxins (DSAT) will be making the following changes to the report card during this pilot period:
- We removed the name of the Responsible Official and list of laboratories inspected so that the report card will not reveal sensitive information and an entity that chooses to can disclose their inspection report card (summary).
- We included the number of low and moderate departures in the inspection results section.
- We use numbers instead of percentages in the pie chart.
Points of Clarification:
- DSAT does not intend to share entity-level inspection report cards with the general public. The report card will be provided to an entity as a part of the inspection report when it is issued. As such, the report card will be treated like entity inspection reports are treated, which currently means that CDC will withhold (1) that portion of a report card that identifies a listed agent or toxin; and/or (2) that portion of a report card that identifies the identity or location of a specific registered entity in response to a Freedom of Information Act request. An entity, of course, may share its inspection report card if it desires to.
- DSAT is currently conducting a pilot for use of the report cards. Use of the report card is currently being considered by the Agriculture Select Agent Services (AgSAS).
- Consideration of repeat departures will go back three years, and these repeats could have an adverse effect on an entity’s report card. FSAP expects an entity to implement the corrective action stated in their response to an inspection report, and then continue with that corrective action throughout the three year inspection history.
- The report card will be issued as an appendix to the inspection report and not as a separate document.
Thanks to everyone who provided feedback and comments on the severity scoring and report cards. FSAP will continue to work to improve the quality and consistency of inspections. Other suggested changes proposed by entities may be considered and implemented later, and if so, will be accompanied by an SA Gram.
The Federal Select Agent Program will hold a multi-day in-person workshop for Responsible Officials from December 6-8, 2016 in Riverdale, MD each day from 8 AM to 4 PM EST. The workshop will provide participants with information about maintaining select agent regulatory compliance, tailored to different types of entities, as well as an opportunity to network with colleagues. An agenda providing more details on the specific workshop topics is attached.
Registration is required and limited to 200 participants. The workshop is open to Responsible Officials or Alternate Responsible Officials only. To register for the workshop, please submit the attached registration form by email to AgSAS@usda.gov or fax to (301) 734-3652. Registrations will not be accepted after October 28, 2016.
The workshop will be held at the Animal and Plant Health inspection Service Agriculture Select Agent Services building, 4700 River Road, Riverdale, MD 20737.
Effective 8/24/2016, personnel who have an active Security Risk Assessment (SRA) approval and apply for access at a different entity will not have to undergo another SRA. The process for requesting access approval for these individuals is as follows:
- The Responsible Official from the entity requesting the individual be added to their registration should follow the instructions for adding individuals to an entity’s registration outlined in the Instructions for the Completion of APHIS/CDC Form 1 posted on www.selectagents.gov.
- In addition, provide the individual’s Department of Justice (DOJ) identifying number in a cover letter. Do not list any DOJ numbers on the applicable APHIS/CDC Form 1 section(s).
- An Issuance of Unique Identifying Number for Individuals Requiring Security Risk Assessments letter containing a new DOJ number for the individual at the requesting entity will be provided.
- Do not submit a FD-961 form, fingerprints, and photograph to the FBI/CJIS. Once the existing SRA is verified, a Notice of Approval for Access to Select Agents and/or Toxins letter will be sent to the requesting entity.
- The expiration date for access approval will be based on the SRA expiration and will be the same at all entities. It will not be 3 years from the access request. For example, if the SRA expires in 18 months, access approval will only be valid for 18 months.
This new process only applies to personnel who have an active SRA. Individuals whose SRA was withdrawn or terminated more than 30 days prior will have to undergo a new SRA. The requesting entity for these individuals must follow the instructions for reactivating individuals outlined in the Instructions for the Completion of APHIS/CDC Form 1 posted on www.selectagents.gov and resubmit a FD-961 form, fingerprints and a photograph for the individual.
When submitting a request to renew the SRA approval for an individual who is active at two or more entities, only one FD-961 form (plus fingerprint set and photograph) that lists only one of their DOJ numbers needs to be submitted to the FBI/CJIS. Once the SRA is complete, the status will be communicated to all entities that the individual is listed on the registration. It is the responsibility of the entities and the individual to determine which entity submits the SRA renewal request.
I am pleased to share that today CDC announces the selection of Samuel S. Edwin, Ph.D., as the new permanent director of the agency’s Division of Select Agents and Toxins (DSAT).
Dr. Edwin comes to CDC after serving as the responsible official and biological surety officer at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, MD. In all, he has been associated with biomedical research for over 30 years.
Dr. Edwin is expected to begin his new assignment in September 2016. At that time, I will return to my job as deputy director and chief medical officer of CDC’s Office of Public Health Preparedness and Response.
The Federal Select Agent Program (FSAP) is pleased to announce that today we have published our first annual report of aggregate program data, the 2015 Annual Report of the Federal Select Agent Program, as part of our ongoing commitment to increasing transparency of the FSAP. The full report, along with accompanying materials including an infographic and questions and answers (Q&A), is now available online at http://www.selectagents.gov/resources/publications/annualreport/2015.htm.
Data contained within the report provide further insight into work conducted with biological select agents and toxins at laboratories across the nation, as well as the regulatory functions of the FSAP. The report summarizes 2015 program data in areas such as:
- Numbers and types of registered entities
- Security risk assessments performed
- Number of inspections conducted
- Top select agents/toxins registered by entities
- Key observations related to inspection findings and compliance with the select agent regulations
- Identifications and transfers of select agents or toxins
- Thefts, losses, and releases of select agents or toxins
The report represents just one part of FSAP’s continued efforts to improve the program in order to enhance its ability to conduct quality oversight of laboratories working with potentially dangerous pathogens. While the report follows recent recommendations that FSAP develop such a report (including recommendations from the CDC 90-day Reviewpdf icon and the report of the Fast Track Action Committee on Select Agent Regulationspdf iconexternal icon), today’s publication represents the beginning – not the end – of efforts to increase transparency and engagement through the regular sharing of detailed program data.
Today, FSAP issued a revised policy statement regarding the inactivation of Bacillus anthracis. The new policy replaces the previous FSAP policy statement on the subject (issued November 30, 2015) and includes a number of changes to better clarify requirements for working with inactivated B. anthracis as a non-select agent, increase flexibility, and allow for additional exclusions.
The new policy, which takes effect immediately, will be posted online at http://www.selectagents.gov/. The intent of these changes is to further ensure both (1) the safety of those who work with these presumed inert materials and (2) limited access to live B. anthracis by those intending to do harm.
Highlights of the new policy are as follows:
- The policy no longer applies to waste disposal. Policy language has been clarified to emphasize that inactivation policy applies to materials intended for further use after being subjected to an inactivation procedure.
- The addition of exclusion categories. The policy now states that inactivated material that has been subjected to the following procedures is now excluded from the requirements of the policy:
- Heat treatment with proper viability testing using control samples.
- Chemical inactivation using longer viability testing incubation times to detect sub-lethally injured vegetative cells or spores.
- Increase in filter pore size required for untreated preparations. The filter pore size requirement has changed from 0.1 µm to 0.22 µm based on feedback that the use of a 0.1 µm filter with viscous material (i.e. serum) creates a biosafety risk due to “splash back” of the material. In addition, more entities should now be able to meet the requirements of the policy without the need for a waiver.
- Reduction of the agar culturing requirements for untreated filtered preparations. The agar culturing requirements have changed from plating 10% of the broth culture to plating 100 µl of the broth culture based on feedback that plating 10% of a broth culture onto plates is not feasible for large volume cultures.
- Clarification of the validation required for chemically-treated whole tissue specimens (such as formalin fixed tissue). The policy states that an inactivation method must be validated initially to the exact conditions that will be used for subsequent inactivation.
FSAP considered feedback from subject matter experts and the regulated community in the development of this revised policy. The policy is expected to continue to evolve over time as more information becomes available in this emerging area of research and discussion.
Entities may also continue to follow the requirements of the previous, more stringent policy, if desired.
Additional information regarding this policy is available at: http://www.selectagents.gov/compliance/faq/bacillus.htm.
On May 27, 2016 the Federal Select Agent Program (FSAP) requested comments from the regulated community on the Select Toxin Guidance document to improve its clarity and utility. FSAP has considered the comments received and revised the Select Toxin Guidance document accordingly. The finalized guidance is now posted at http://www.selectagents.gov/compliance/guidance/index.htm. Further comments or questions about this guidance document can be submitted to either LRSAT@cdc.gov or AgSAS@usda.gov.
Please note that this guidance document addresses the current select toxin requirements. Earlier this year a Notice of Proposed Rulemaking (NPRM) was published that proposed changes to some of the select toxin requirements. If any of the proposed regulatory changes to the select toxin requirements are finalized as a part of the Final Rule, the applicable updates to the guidance document will be made at that time.
As a part of the Federal Select Agent Program (FSAP)’s efforts to increase the quality and consistency of inspections, FSAP has developed several initiatives which we would like to share with the regulated community for comment and further input. This notice aims to update on two of these key items and solicit feedback on the following:
Severity of inspection departures and enforcement actions
FSAP has developed a spreadsheet that outlines categories of inspection departures grouped according to the level of severity, as well as related enforcement options that may be applied. The intention of this document is to provide awareness of how FSAP considers the severity of inspection findings and provide visibility to the application of enforcement options to these findings. Example violations are grouped into a three-tier risk scoring system in the categories of low, moderate, and serious severity levels.
Departures may include findings of low risk as well as findings that may lead to an immediate stoppage of some or all activities. Please note that this is not meant to be an all-inclusive list of possible departures, but is meant to convey, at a large scale, how FSAP views risk and allow the regulated community the chance to provide feedback on this approach. We welcome input from the regulated community.
Inspection report cards
The Centers for Disease Control and Prevention (CDC)’s Division of Select Agent and Toxins (DSAT) intends to conduct a six month pilot for issuing inspection summaries (“report cards”) to DSAT-registered entities, along with the inspection report, to summarize the entity’s regulatory departures following an inspection and show how its performance compares relative to other entities. Sample inspection report cards have been developed. We welcome input from the regulated community on this approach. DSAT plans to begin issuing these inspection report cards in the coming weeks, and the Animal and Plant Health Inspection Service’s Agriculture Select Agent Services (AgSAS) will implement a similar system to issue report cards at a later date.
In addition, for reference, FSAP has developed a third document that summarizes complexity information on registered entities, in order for the regulated community to better understand how similar entities will be compared in these report cards. Based on a number of variables related to the work conducted at each entity, complexity categories have been assigned to each entity.
These efforts have been developed to address a number of program improvement recommendations received as part of the CDC 90-day Review and the Fast Track Action Committee on the Select Agent Regulations, including:
- CDC 90-Day #1pdf icon: Reduce potential variability of inspections
- CDC 90-Day #4pdf icon: Better characterize severity of inspection findings
- CDC 90-Day #5pdf icon: Prioritize and strengthen enforcement actions to highest risk violations
- CDC 90-Day #7pdf icon: Analyze trends and associations between inspection findings and risk
- FTAC #9pdf iconexternal icon: Categorize inspection findings
Sandia National Laboratories (SNL) is conducting, on behalf of the Federal Select Agent Program, a study on evaluating and improving risk assessment in the management and oversight of biological select agents and toxins (BSAT). SNL seeks the input of the regulated community on how risk assessment is currently utilized in your organizations and on improvements in risk assessment that would be beneficial to safety and security of BSAT.
Each webinar session will require only about 20 minutes of your time and you need only attend one session. All input will be aggregated before presentation to anyone outside SNL and no attributions will be made for any data. Demographic information will be collected but will not be linked to any input.
Please click the appropriate link to register for the session you choose to attend. Registration requires your name, email, organization/company, title, city and state. You have the option of entering other identifying information, but it is not required. After registration, you will be sent the discussion questions for your consideration and preparation.
The webinar forums are scheduled for the following dates and times. You need only attend ONE session:
- Wednesday 8 June, 2016
12pm Eastern Time
Register Hereexternal icon
- Thursday 9 June, 2016
5pm Eastern Time
Register Hereexternal icon
- Friday 10 June, 2016
1pm Eastern Time
Register Hereexternal icon
- Monday 13 June, 2016
11am Eastern Time
Register Hereexternal icon
While we will not be confirming that each registrant is a representative of a regulated entity, we ask your courtesy to only register and participate if you are representing a regulated entity.
Questions may be sent to:
LouAnn C. Burnett, MS, CBSP
The Federal Select Agent Program (FSAP) is offering the opportunity for the regulated community to submit written comments regarding Select Toxin Guidance (download here). FSAP requests comments related to this guidance to improve its clarity and utility. Comments can be submitted to either LRSAT@cdc.gov or AgSAS@usda.gov and will be accepted until June 10, 2016. FSAP will consider all comments submitted regarding the draft guidance. The finalized guidance will be posted at http://www.selectagents.gov/compliance/guidance/toxin/index.htm.
Please note that this guidance document addresses the current select toxin requirements. Earlier this year a Notice of Proposed Rulemaking (NPRM) was published that proposed changes to some of the select toxin requirements. If any of the proposed regulatory changes to the select toxin requirements are finalized, the applicable updates to the guidance document will be made at that time.
The Federal Select Agent Program plans to conduct a multi-day in-person workshop for Responsible Officials December 6-8, 2016 in Riverdale, MD. The workshop will be an opportunity to learn more about maintaining select agent regulatory compliance at your entity and network with your colleagues. As we develop our workshop topics, we would like suggestions on possible agenda items. Please send your suggestions to LRSAT@cdc.gov or AgSAS@usda.gov no later than June 3, 2016.
The Federal Select Agent Program has posted on our website the FBI’S, newly revised OMB approved FD-961 form. The link to this form has been updated on our website at: http://www.selectagents.gov/compliance/risk.htm.
After May 8, 2016, the FBI will only be accepting this new FD-961 form (OMB No. 1110-0039; expiration date 4/30/2018). Previous versions of the FD-961 will not be accepted after May 8, 2016 and will result in return of the form to the submitter. This could result in the delay of processing an individual’s security risk assessment.
If you have any questions regarding the FD-961 form, please contact FBI CJIS at 304-625-4900.
A key focus of recent reviews of the Federal Select Agent Program (FSAP) was to make recommendations to improve the process for inspections at registered entities working with these potentially dangerous and deadly biological pathogens – particularly with regards to facility inspections and reporting of inspection findings.
As a part of CDC’s internal 90-day program review of the Division of Select Agents and Toxins (DSAT), recommendation 2A specifically called for DSAT to initiate analysis of inspection report timeliness data so that the division can identify opportunities to improve the issuance of final reports within 30 days after an inspection. The review also called for DSAT to release this information to the regulated community annually.
In response to this recommendation, DSAT has prepared and published its first timeliness report, the 2015 DSAT Inspection Report Processing Annual Summary. The report (available herepdf icon) analyzes inspection report timeliness throughout 2015, looking at variables such as time from inspection close to report issuance by entity type and type of inspection. DSAT intends to issue this external report on an annual basis moving forward.
We invite you to take a look at the report, and believe the data will help to provide additional insight into the daily work of the program.
As you likely know, three federal reviews were released last fall, each containing recommendations designed to strengthen the federal government’s biosafety and security practices and oversight, both through the Federal Select Agent Program (FSAP) and at a broader national level. At around the same time, FSAP also invited members of this listserv to provide feedback on the program through an anonymous survey. Those who took the survey gave us a wealth of valuable feedback regarding both program successes and areas for improvement. Many of the recommendations complement each other and support the same focus areas.
Over the past several months, the FSAP has been hard at work assessing the recommendations and feedback received and implementing an action plan to move forward with appropriate program changes and improvements to address these areas. Our efforts have focused on four main categories of improvement, focusing on the inspection process (both facility inspections and inspection reporting), customer service, incident response, and transparency and public engagement.
CDC’s Division of Select Agents and Toxins has created a website in order to keep you updated on the work that is underway at CDC and to inform you of the changes to the program that you will begin to see as these items roll out. The website, now available here, is designed to extract and summarize the recommendations relevant to CDC’s role within the Federal Select Agent Program, collect them in one place, outline actions that have been identified to address each, and provide an update on progress towards implementation of those recommendations. Many of these activities stemmed from not only the federal reviews, but also the feedback provided by you as part of the survey this past fall.
We are excited about the changes, and believe that these improvements will greatly enhance our ability to provide you with the quality oversight and guidance that you expect and deserve from our program.
We will continue to keep you updated as our work progresses. Please feel free to share this website with others, including other members of your organization.
The Federal Select Agent Program (FSAP) has posted a regulatory interpretation for “SRA approved laboratorians working at unregistered facilities with excluded levels of toxins.
This is in response to an email request dated March 14, 2016, for a regulatory interpretation regarding (1) whether a laboratorian may work at an unregistered entity with excluded amounts of toxins; and (2) whether a Principal Investigator may work at an unregistered entity with excluded amounts of toxins.
The request stated that the non-registered government facility in which the laboratorian or Principal Investigator would like to work purchases and utilizes excluded amounts of toxins and is not registered with the Federal Select Agent Program. The request also stated that the facility owns the toxin, controls the operations and the inventory of the excluded amounts of toxins.
One of the criteria for a select toxin to be excluded from the requirements of the select agents and toxins regulations (42 CFR Part 73) is that the aggregate amount of toxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not, at any time, exceed the amounts listed in 42 CFR §73.3(d)(3). For purposes of this regulatory interpretation, the FSAP is assuming that the non-registered facility is neither a commercial manufacturer nor a distributor of a select toxin.
- A laboratorian may work at an unregistered entity with excluded amounts of toxins so long as the toxin possessed by the unregistered entity is under the control of a Principal Investigator (as that term is defined by 42 CFR §73.1) or treating physician or veterinarian that is affiliated with the unregistered entity; and the aggregate amount of the toxin does not, at any time, exceed the amount specified in the select agent regulations (§73.3 (d)(3)).
- A Principal Investigator (as that term is defined by 42 CFR §73.1) may work at an unregistered entity with excluded amounts of toxins so long as the toxin possessed by the unregistered entity is under the control of a Principal Investigator that is affiliated with the unregistered entity; and the aggregate amount of the toxin does not, at any time, exceed the amount specified in the select agent regulations (§73.3 (d)(3)).
The policy statement can be found here.
In September 2014, the White House National Security Council (NSC) staff tasked the Federal Experts Security Advisory Panel (FESAP) to, among other things, identify actions and regulatory changes to improve biosafety and biosecurity. In December 2014, the FESAP published the Report of the Federal Experts Security Advisory Panel that identified needs and gaps, and made recommendations to optimize biosafety, biosecurity, oversight, and inventory management and control for biological select agents and toxins.
As part of its proposed enhancements to select agent regulatory guidance, the FESAP recommended that the Federal Select Agent Program (FSAP) amend its guidance documents to suggest that entities consider establishing policies on maximum work hours for those that work in high containment laboratories (See Recommendation 2.7, December 2014 Report of the Federal Experts Security Advisory Panelpdf iconexternal icon).
In lieu of issuing new guidance on this topic, the FSAP is using this notice to draw attention to an important issue and encourage regulated entities to consider it in their internal plans and policies. The FSAP will not be setting standards for work hours. The FSAP does not intend to promulgate any select agent requirements for maximum work hours.
The FSAP supports the FESAP recommendation that entities consider establishing policies on maximum work hours for those in high containment laboratories. We further encourage that these policies reference guidance on work hours that may be provided by the Occupational Safety and Health Administration (OSHA). While there may on rare occasions situations when lengthy work schedules are needed to respond to emergencies, there should be consideration for the risk to workers of engaging in extended work periods in hazardous settings. Considerations for a policy might include requiring the notification of entity leadership of the intention to work beyond what would be considered normal work periods, or work beyond a maximum number of hours for an extended period.
On February 8, 2016, the Federal Select Agent Program (FSAP) offered the ability for the regulated community to submit written comments on a process for a registered entity to dispute FSAP inspection report findings. FSAP would like to thank those that provided feedback. Based on the comments received, FSAP is announcing a process for a Responsible Official (RO) at a registered entity to dispute an inspection report observation requiring the registered entity to take a corrective action.
Within fourteen (14) calendar days from receipt of the inspection report, an RO may provide written notification to the Agriculture Select Agent Services (AgSAS) Unit Director or the Division of Select Agents and Toxins (DSAT) Operations Branch Chief of the registered entity’s intention to dispute a specific inspection report observation requiring the registered entity to take a corrective action. Information on how to submit the written notification will be available on the inspection reports sent to the RO.
Within thirty (30) calendar days of the receipt of the inspection report, the RO will be expected to provide written evidence that clearly states the reason(s) why the registered entity believes an inspection report observation requiring corrective action is in error. The RO will be expected to include any supporting documentation.
The goal of the FSAP will be for the AgSAS Unit Director or the DSAT Operations Branch Chief to resolve the dispute with the RO within thirty (30) calendar days of the receipt of the RO’s written evidence that clearly states the reason(s) why the registered entity believes an inspection report observation requiring corrective action is in error. The attempt for resolution of a dispute may include discussions with the entity or site visits.
If resolution of a dispute is not reached to the satisfaction of the RO, the RO may submit a request for reconsideration to the AgSAS Director or DSAT Director, as appropriate.
If the resolution of a dispute results in a change to an observation of an inspection report or to the required corrective action, the agency issuing the inspection report will issue an addendum to the inspection report.
Based on seriousness and need for immediate action, the FSAP may notify a registered entity that a corrective action specified in an inspection report will be required to proceed notwithstanding the dispute of an inspection report observation.
The Federal Select Agent Program (FSAP) would like to announce a webinar in collaboration with the Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) to discuss changes to the FD-961 Bioterrorism Risk Assessment Form. We will also present information on the FSAP security risk assessment process.
An FD-961 form must be submitted to CJIS as part of a security risk assessment (SRA). An SRA is the electronic records check performed by the Federal Bureau of Investigation (FBI), Criminal Justice Information Services Division (CJIS) to determine whether an entity or an individual who wishes to register to possess, use or transfer a select agent or toxin, or an individual who has been identified by a registered entity as having a legitimate need to access a select agent or toxin meets one of the statutory restrictors which would either prohibit registration or restrict access, respectively. The results of an SRA will assist FSAP in its determination that the entity may possess, use, or transfer select agents or toxins; or that an individual may have access to biological select agents and toxins (BSAT).
We will hold two sessions on April 19 to accommodate those in different time zones. For those in Eastern and Central time zones, please plan to attend the morning session. Sessions are limited to 200 participants.
As the Federal Select Agent Program (FSAP) begins a review of the guidance documents posted on our website, you have the opportunity to participate in a short, anonymous survey concerning how we might make those documents better. We would also like your opinion on the need for biosafety, incident response and security plan development tools to assist entities with compliance to the select agent regulations. As we are looking for direct feedback, please use the “comment” fields to provide specific comments on areas that you would like for us to address.
Click here to begin the survey. It should take you no more than 15 minutes to complete. The survey will remain open until April 11, 2016.
If you have any questions regarding the survey, please contact the FSAP at the following phone numbers: APHIS/AgSAS, 301-851-3300 option 3 (voice only) or CDC/DSAT, 404-718-2000.
This e-mail is to notify you that the FD-961 form used by individuals to submit information to the Federal Bureau of Investigation, Criminal Justice Information Services Division (CJIS) for security risk assessment has expired. CJIS will continue to accept this expired form, FD-961 (OMB No. 1110-0039 (Exp. 2-29-2016) until further notice.
The Federal Select Agent Program (FSAP) is offering the ability for the regulated community to submit written comments regarding the Guidance for Nonviable Select Agents and Nonfunctional Select Toxins. This invitation is the Federal Select Agent Program (FSAP)’s commitment to be more transparent to our regulated entities. FSAP requests comments related to this guidance to improve its clarity and to minimize unintended consequences that would result from its implementation. Comments can be submitted to either LRSAT@cdc.gov or AgSAS@usda.gov and will be accepted until March 14, 2016. The finalized guidance will be posted here.
If you have any questions regarding this email, please contact the Federal Select Agent Program at email@example.com.
The Federal Select Agent Program (FSAP) is offering the ability for the regulated community to submit written comments regarding the “Inactivated Bacillus anthracispdf icon” policy. This invitation is the Federal Select Agent Program (FSAP)’s commitment to be more transparent to our regulated entities. FSAP requests comments related to this policy to improve its clarity and to minimize unintended consequences that would result from its implementation. Comments can be submitted to either LRSAT@cdc.gov or AgSAS@usda.gov and will be accepted until March 17, 2016. FSAP will consider all comments submitted regarding the below draft policy. The finalized policy will be posted here.
On November 30, 2015 the Federal Select Agent Program (FSAP) issued the policy statement that unless waived by the APHIS Administrator or HHS Secretary, it is the policy of the FSAP that all vegetative cell and spore preparations of Bacillus anthracis strains regulated as select agents that were subject to an inactivation procedure on or after June 2, 2015 are considered a select agent and the storage, transfer, or work with this material must comply with regulations found at 42 CFR 73 and 9 CFR 121 until a more comprehensive protocol for inactivation of B. anthracis and confirmation of non-viability can be established and validated.
Bacillus anthracis is a hardy organism and has been involved in multiple episodes of inactivation failures and raised questions of the treatment (e.g. chemical, irradiation) used in some inactivation protocols as seen in a recent article on chemically inactivated vegetative cells and spores (Ref 1). These treatments may not inactivate Bacillus anthracis spores completely and standard viability testing procedures may not allow for the detection of sub-lethally injured spores.
To ensure both the safety of those who will work with these presumed inert materials and the security to limit access to live B. anthracis by those intending to do harm, we are revising and clarifying the new B. anthracis inactivation policy. We are seeking comment from the regulated community in advance of finalizing the policy and would like to draw your attention to the following issues:
- Initial validation of inactivation protocols and viability testing (chemical and autoclave for future use) using 100% of the inactivated material. Would this pose a problem for some material such as large volume cultures? Would it provide greater confidence in the effectiveness of the inactivation method?
- Doubling “contact time” of the projected zero-growth treatment derived from kill curves as an added safety margin. Does this concept apply to chemical treatment as it does for irradiation? Is this requirement feasible? If not, why?
- Extending broth and plate culture incubation for chemically treated samples to capture delayed growth of sub-lethally injured cells and spores. Does this added measure capture the risk posed by sub-lethally injured cells and spores that result from chemical inactivation as we understand it today? Should this extended culture incubation be applied to filtered materials?
- Initial validation of neutralization of chemical or antimicrobial treatments using 100% of the material and the following positive control: Split the sample into two portions, and to one, add 10 B. anthracis (Sterne) spores to determine if the chemical or antimicrobial activity interferes with the viability test. Would this pose a problem for some material?
- Use of neutralization conditions that are double the projected complete neutralization treatment conditions derived from the neutralization curves as an added safety margin. Would this pose a problem for some material?
- Static liquid cultures, versus shaking incubations, are commonly practiced in BSL-3 laboratories to reduce risk. Are static broth culture incubations effective for the viability test methods described?
- The feasibility of viability testing every treated and untreated sample. Should every sample be tested or a sample of batched results? Is this feasible?
- Use of methods used in Good Manufacturing Practices (GMP) for untreated samples such as double filtration with culture of the second filter to confirm non-viability. GMP is often associated with a licensed or regulated product that is used for human or animal consumption and therefore as part of that regulation a higher standard is set for those materials. The purpose and safe use of research material differs from GMP materials since there is no intent to ingest the materials, yet low levels of organism that do not appear to present a safety risk can present a security risk if materials leave containment while being capable of replicating. Is GMP for research materials a feasible and meaningful target for biosecurity?
If you have any questions regarding this message, please contact the Federal Select Agent Program at firstname.lastname@example.org.
Following the high-profile laboratory incidents involving select agents and toxins that occurred at federally regulated laboratories, the National Science and Technology Council established a Fast Track Action Committee on the Select Agent Regulations(FTAC-SAR) under the Subcommittee on Biological Defense Research and Development of its Committee on Homeland and National Security. The FTAC and the White House Office of Science and Technology Policy convened two listening sessions and published a Request for Public Comment in the Federal Register to engage input into how the Select Agent Regulations (SAR) have impacted science, technology, and national security in the United States. Based on this input, the FTAC published the Fast Track Action Committee Report that offered recommendations for FSAP program improvement.
Recommendation #6 (Inventory Control Requirements) The FTAC recommends retaining requirements to maintain inventories of samples containing biological select agents and toxins, while ensuring that BSAT institutions are not requested to characterize biological agents quantitatively. Specifically, the FTAC-SAR expressed agreement with the limitations inventory controls to detect and mitigate theft, while expressing belief that institutions possessing select agents and toxins are obligated to know and document what is stored in their laboratories and where those agents and toxins are located as a matter of quality management. It is therefore appropriate, report concluded, to require institutions to maintain inventories of their select agent stocks and be able to show not only that all their samples are documented, but that all entries in an inventory database correspond to physical samples. The Select Agent Regulations (SAR) do not require volumetric quantitative inventory controls for select biological agents, only for select toxins. The FTAC therefore recommends that accountability in the SAR be maintained at the level of identifiable physical items, such as vials or plates, and not extended to quantitative measurements of volume, mass, or concentration of biological agents (other than as needed to describe them qualitatively). Currently, record keeping and inventory validation do not require accounting for and verifying biological agent concentrations or volumes.
In response to FTAC Recommendation #6, the FSAP would like to confirm that the SAR do not require volumetric quantitative inventory controls for select biological agents, only for select toxins. Therefore, the FSAP inspectors will review inventory at the level of identifiable physical items, such as vials or plates, and not at the level of quantitative measurements of volume, mass, or concentration of biological agents. If the FSAP inspectors see gross discrepancies in volume between the inventory records and samples where sample volumes are recorded, they will note the discrepancy in the report but not cite this observation as a regulatory departure. The purpose of including on the inspection report will be to assist responsible leadership at the entity to recognize a possible breach in quality management that might warrant further review.
On February 18, 2017, the OIE (World Organisation for Animal Health) reported samples obtained from live bird markets in China, sent to the National Reference Laboratory for Avian Influenza by the Guangdong veterinary authorities, tested positive for H7N9 highly pathogenic avian influenza virus  (HPAIV). Retrospectively, samples were identified as H7N9 HPAIV in Guangdong extending back to as early as October 2016. This Asian lineage H7N9 HPAIV is not related to the recent finding of North American wild bird lineage H7N9 HPAIV in United States (US) poultry during March 2017.
The Asian H7N9 lineage was first reported in February 2013 as a low pathogenic avian influenza virus (LPAIV) which continues to circulate primarily in live bird markets in China, and causes human morbidity and mortality. As of April 2017, the Asian lineage H7N9 HPAIV has been isolated from poultry, the environment, and from people (http://www.fao.org/ag/againfo/programmes/en/empres/h7n9/situation_update.htmlexternal icon).
In light of these recent findings, additional supporting information will now be required for facilities requesting Asian lineage H7N9 strains in order to differentiate LPAIV from HPAIV. HPAIV is a USDA VS Select Agent, and may only be possessed, used or transferred in the United States by entities registered with the Federal Select Agent Program.
In general, any request to receive low pathogenicity avian influenza A viruses for import and/or interstate transportation requires a VS 16-6 permit from the National Import Export Service (NIES), Organisms and Vectors (OV) Unitexternal icon. This permit can be requested via the VS 16-3 permit application.
As of the date of this notice, facilities requesting to receive Asian lineage H7N9 LPAIV will also be required to obtain a letter of exclusion at the time of the VS 16-3 permit application submission, which indicates that the material requested demonstrates a low pathogenicity phenotype. To obtain a letter of exclusion, provide either A) HA-gene sequence data consistent with H7N9 LPAIV genotype, and in vivo testing per OIE indicating a low pathogenic phenotype (either intravenous pathogenicity index [IVPI] of <1.2, or chicken lethality assay), or B) next generation full genome sequence data with depth of coverage >1000-fold to aid in excluding the potential of co-infection/ contamination with a high pathogenicity genotype, and duplicate plaque characterization testing using chicken embryo fibroblast cells (or other suitable cell line) with and without trypsin. Data should be sent to AgSAS@usda.gov.
A facility requesting to receive Asian lineage H7N9 LPAIV will also be required to request a letter of exclusion from APHIS (indicating that the material requested demonstrates a low pathogenicity phenotype) at the time of the VS 16-6 permit application submission.
Permit application requests to Centers for Disease Control (CDC) for the importation of Asian lineage H7N9 strains will be held by CDC until an approved APHIS VS 16-6 permit is submitted to the CDC Import Permit program as supporting documentation.
Movement of all other HPAI material requires an APHIS/CDC Form 2 “Request to Transfer Select Agents and Toxins”.
Additional information related to avian influenza viruses can be found here.
If you have any questions regarding this notice, please contact the Federal Select Agent Program at 301-851-3300 option 3 (8:00 am to 4:30 pm Eastern) or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.
 There are molecular and biologic criteria, specific to chickens, which define an avian influenza virus as either low or high pathogenicity. Such criteria do not address infectivity nor pathogenicity in humans.
The Federal Select Agent Program is pleased to announce that we have posted the presentation slide deck and video recording from the November 19, 2015 webcast regarding specific regulatory guidance and information on standards concerning biosafety, biosecurity and incident response issues related to the Federal Select Agent Program. The video and presentations are available for download here.
The Federal Select Agent Program (FSAP) is offering the ability for the regulated community to submit written comments on a policy which outlines the process for a registered entity to formally dispute FSAP inspection report findings. This invitation for feedback reflects the FSAP’s commitment to improve its customer service and better serve the regulated community. Please note:
- FSAP requests comments related to this policy in order to improve its clarity and to avoid unintended consequences that would result from its implementation.
- Comments can be submitted to either LRSAT@cdc.gov or AgSAS@usda.gov and will be accepted until February 19, 2016. FSAP will consider all submitted comments.
- This policy is still in development and does not reflect official guidance; once finalized, the official policy will be posted at: http://www.selectagents.gov/regulations/index.htm and a SA Gram distributed indicating the effective date of the policy.
The draft policy for which we are soliciting feedback is as follows:
It is the policy of FSAP that a registered entity through its Responsible Official (RO) will have the opportunity to dispute an inspection report observation requiring corrective action. The RO should submit the dispute to the AgSAS Unit Director or DSAT Operations Branch Chief to initiate the review process. To ensure an accurate record, the dispute should be in writing, either by letter or email, and should clearly and concisely state the reason(s) why the registered entity believes an inspection report observation requiring corrective action was in error. The RO should also include any supporting documents. The dispute should be submitted within thirty (30) calendar days from receipt of the inspection report or the inadequate response letter. The AgSAS Unit Director or the DSAT Operations Branch Chief will attempt to resolve the concerns with the RO within 14 days of receipt. If resolution is not reached to the satisfaction of the RO, the issue will be referred to the AgSAS Director and DSAT Director for final resolution. If the dispute results in a change(s) to the findings of an inspection, the agency issuing the inspection report will issue an addendum to the inspection report.
On January 19, 2016, the Departments of Health and Human Services (HHS) and Agriculture (USDA) published in the following Federal Register notices of proposed rulemaking regarding the select agents and toxins regulations:
- HHS Notice of Proposed Rulemaking
- USDA Notice of Proposed Rulemaking
In the notices, HHS and USDA are considering whether to amend the select agent list by removing the following six biological agents:
- Coxiella burnetii
- Rickettsia prowazekii
- Bacillus anthracis Pasteur strain
- Brucella abortus and B. suis
- Peronosclerospora philippinensis (Peronosclerospora sacchari)
- Phoma glycinicola (formerly Pyrenochaeta glycines)
- Sclerophthora rayssiae
HHS is considering whether to amend the select agent list by removing B. melitensis, which means this select agent would be identified as “USDA-only” select agent.
In addition, to address concerns related to inactivation of select agents, biosafety procedures, confirmation of the identification of a select agent, and to clarify the current regulatory language, we are also proposing the following new requirements:
- For a select agent to be considered “non-viable,” and therefore excluded from the requirements of the regulations, an entity will be required to use a validated inactivation method. As part of the inactivation procedure, an entity will be required to develop a site-specific kill curve to identify conditions of inactivation for each select agent or regulated nucleic acid. In addition, a validated sterility testing protocol to ensure that the inactivation method has rendered a select agent non-viable, or regulated nucleic acid non-infectious, will be required.
- A requirement for a reference laboratory, which would conduct testing to confirm the identification of a select agent or toxin, to inform the specimen provider of a confirmation so the specimen provider will be aware they are in possession of a select agent or toxin and are subject to the select agent regulations.
- A requirement that the biosafety and incident response plans be submitted for initial select agent registration, renewal of registration, or when requested by Federal Select Agent Program (FSAP).
- New specific requirements in the biosafety section would include: a written risk assessment for each registered select agent or toxin; written safety procedures to protect entity personnel, the public, and the environment from exposure to the select agent or toxin; written decontamination procedures; and written waste management procedures.
- A requirement that a laboratory-specific biosafety manual must be accessible to individuals entering a laboratory registered for select agents or toxins.
- Amend existing requirements for the security plan so that the security plan’s description of how the entity authorizes the means of entry into areas where select agents or toxins are stored or used would include description of centralized access control management systems (e.g., keycards) and/or key management (mechanical keys).
- Require that required drills or exercises be documented to include how the drill or exercise tested and evaluated a plan, any problems identified and corrective actions that were taken, and the names of the individuals who participated in a drill or exercise.
- The rulemaking would codify existing policy that all individuals who have received FSAP approval to have access to select agents and toxins will be required to have training that addresses the particular needs of the individual and the risks posed by the select agent or toxin, regardless of whether they routinely access select agents or toxins.
All comments should be submitted by March 21, 2016. Web links to the Federal Register Notices will be available here.
On July 21, 2015, the Federal Select Agent Program advised Responsible Officials and alternate Responsible Officials of a Federal Express (FedEx) announcement that FedEx would no longer ship select agents and toxins. We understand that the loss of FedEx as a courier has made it more difficult and expensive to ship select agents and toxins. We also understand the temptation to change the usual practice of first confirming a select agent or toxin so that FedEx may ship the material as a “suspect” or “diagnostic” sample. Although the packaging for biological select agents and Category A infectious materials are the same, there are additional protections involved with shipping a select agent or toxin and we discourage the practice of delaying confirmation in order to ship this way. As a reminder, shipping a known select agent or toxin without prior approval by AgSAS or DSAT, even if it is labeled as an “unknown or diagnostic specimen,” is a violation of select agent regulations.
Please note that the select agent regulations allow the Federal Select Agent Program discretion to allow for an extension to the seven calendar days after identification for the completion of the requirement to transfer or destroy the confirmed/identified select agent or toxin.
A potential safety concern regarding select agents has been brought to the attention of the Federal Select Agent Program (FSAP). Based on information provided to FSAP, it appears that there may be laboratories using the QIAamp Viral RNA Mini Kit inappropriately to inactivate select agents (Ref) Such inappropriate use may create a risk that viable select agents are being handled as non-infectious materials.
Based on these concerns¸ you should be aware of the following:
- A select agent must not be treated as non-viable until it has been subjected to a method that has been validated to completely inactivate a specific agent.
- When utilizing DNA/RNA extraction kits as methods for inactivation of select agents, please ensure that you have validated the method for complete destruction of viable select agents.
- The FSAP encourages, whenever possible, that entities subject all inactivation procedures to validation in their laboratories.
Further guidance on rendering select agents non-viable and select toxins non-functional can be found here.
Reference: Smither, S., Weller, S., Phelps, A., Eastaugh, L., Ngugi, S., O’brien, L., Lever, M. (2015). Buffer AVL Alone Does Not Inactivate Ebola Virus in a Representative Clinical Sample Type. J. Clin. Microbiol. Journal of Clinical Microbiology, 3148-3154.
A few months ago, the Federal Select Agent Program (FSAP) invited members of this listserv to participate in an anonymous survey in order to get a better understanding of the level of satisfaction that you have experienced when interacting with our program. The survey was completed by nearly 300 individuals, mostly responsible officials or their alternates, who answered the 11 questions and gave us a wealth of feedback. We appreciate the time that you took to share your perspective and take your feedback very seriously. We also wanted to share some of the key results with you, which are summarized in the attached document.
In reviewing the results, we noted that many of you were pleased with the courtesy, professionalism, and helpfulness of the FSAP representatives. You also gave us valuable feedback as to practices you’d like for us to continue, such as the SA Grams and webcasts. And at the same time, we received feedback that has caused us to take a closer look at certain elements of our program, including inspector training and our timeliness and responsiveness to you.
As you know, FSAP recently received extensive program improvement recommendations from other sources as well (including reports from the CDC 90-Day Internal Review, the Federal Experts Security Advisory Panel, and the White House Fast Track Action Committee on Select Agent Regulations). FSAP is currently assessing all of the recommendations and feedback we’ve received – including yours – and in the coming year, will be moving forward with appropriate changes to improve the quality and effectiveness of our program. We will keep you updated as our work progresses.
The FSAP recognizes that you play a critical role in protecting the safety and security of the American people from biological threats, and we thank you for your feedback.