On Public Health Security - July 2016 - Federal Select Agent Program Making Major Progress to Improve Effectiveness

On Public Health Security - July 2016 - Federal Select Agent Program Making Major Progress to Improve Effectiveness

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On Public Health Security
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July 2016
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Stephen C. Redd

Dear Partners,

As I wrote in November, research with select agents and toxins is incredibly important in helping us improve prevention, detection, and treatment options for diseases considered to be some of the most threatening to public health. CDC and USDA jointly regulate the possession, use, and transfer of select agents through the Federal Select Agent Program (FSAP). FSAP works to ensure that research is conducted as safely and securely as possible by developing regulations for laboratories that work with select agents, conducting inspections of registered facilities, and enforcing regulation compliance.

After high-profile laboratory incidents occurred with select agents at regulated laboratories, three federal reviews were released in fall 2015 – CDC’s 90-Day Internal Review, the Report of the Federal Experts Security Advisory Council (FESAP), and the Fast Track Action Committee Report on Select Agent Regulations (FTAC-SAR). The reviews provided recommendations intended to strengthen biosafety and security practices and oversight through FSAP and at a broader national level. Over the past several months, CDC and USDA have been hard at work improving FSAP in four critical areas.

  • Improving Inspections. FSAP is developing new systems to improve training of inspectors, better categorize the overall severity of inspection findings, and help facilities better understand those findings. The program is also focused on improving the timeliness of inspection reports, and has started issuing interim reports to facilities after an inspection to highlight severe issues requiring immediate corrective action, or to share preliminary observations in advance of the final report. CDC made data available to the public with the publication of its first annual inspection timeliness report.
  • Improving Customer Service. FSAP completed critical work in this area by providing regulated facilities opportunities to provide feedback on the inspection process, as well as request interpretations of the select agent regulations. The program also developed a formal mechanism for facilities to dispute findings in inspection reports.
  • Improving Incident Response. The program is refining reporting systems to obtain more detailed and standardized incident reports which will improve analysis and inform actions that can be taken to prevent risk in the future.
  • Increasing Transparency and Engagement. Last month, FSAP released its first annual report, which provides insight into work conducted with select agents and toxins at laboratories across the nation, as well as how the program provides regulation and oversight of these laboratories. Most laboratories meet the regulations, and FSAP works closely with those that need to make improvements. In 2015, no potential exposures resulted in illness, death, or transmission, either among laboratory workers or people in the surrounding communities. For a quick summary of the report findings, I encourage you to look at this infographic.

CDC details these activities, as well as many more, on our Progress Towards Change website, which you can visit periodically to stay up-to-date. I look forward to your continued support and sharing more information with you regarding our ongoing efforts to improve the FSAP.

Thank you,
Stephen C. Redd, MD
RADM, USPHS
Director, Office of Public Health Preparedness and Response
Centers for Disease Control and Prevention

Noteworthy Events


The Association of Public-Safety Communications Officials (APCO) 2016 Conference is coming up on August 14-17 in Orlando, Florida. This event for public safety communications officials will consist of four days of educational sessions and special events, as well as two days of exhibits.


National Immunization Awareness Month is observed annually in August to highlight the importance of vaccinations for people of all ages. CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) and the National Public Health Information Coalition (NPHIC) have collaborated to create communication toolkits to help organizations promote immunization in their communities.


The 2016 Public Health Informatics Conference will be August 21-24 in Atlanta, Georgia. This is a joint effort of CDC and the National Association of County and City Health Officials (NACCHO), and allows for an opportunity to address the science of public health informatics and the role of public health in the expanding information technology infrastructure of our Nation.

 

Select Agent Resources


The Division of Select Agents and Toxins’ (DSAT) has a newly redesigned website which provides information about its work.


CDC’s Public Health Matters blog features Safeguarding Deadly Pathogens and Poisons, a post that highlights the importance of work with select agents and toxins and the role the Federal Select Agent Program plays in helping to keep this work safe and secure.