ABSA Comments Regarding Operational Issues of the CDC Select Agent Program
a letter written by Stefan Wagener, Ph.D., RBP, CBSP
President, American Biological Safety Association
6 April 2004
April 6, 2004
Centers of Disease Control and Prevention
Attn: Lori Bane
Select Agent and Toxins Program
1600 Clifton Road
Atlanta, GA 30333
Dear Ms. Bane
The American Biological Safety Association (ABSA) appreciates the opportunity to provide comments regarding the operation of the CDC Select Agent and Toxin Program.
1) There has been some variation in the responses received from the CDC select agent staff when the same question has been posed.
2) A frequent response by the CDC staff has been to refer the caller back to the specific part of the regulation that prompted the call. More preparation of the CDC select agent staff in the fine points of the CDC select agent rule prior to its release would help with the provision of consistent guidance from the group.
3) In the future, consider the provision within the text of the regulation or its preamble of some specific examples as to what activities may be covered and what is exempted/not covered. Doing so may help to reduce the number of questions posed to the CDC select agent staff so they can focus on addressing issues that require their insight.
4) The security risk assessment approval system could be improved if, following the submission of the FD-961, a CJIS unique number is assigned and provisional approval for unsupervised access is granted within two (2) weeks of receipt of the remaining required paperwork. The current system does not work well for employers who must seek approvals for staff in high turnover positions, such as custodians, etc. Approvals can often come after such individuals have left an employer. This modification to the system should be considered for organizations that are already registered in the Select Agent Program, since they should have the security, safety, and emergency response plans in effect at their institutions as mandated under the standard.
5) The ability to prepare and submit the Select Agent Program application online is a great improvement in the application process. This should be retained. Consideration should be made for the submission of required information in other areas to the CDC via such online methods.
6) Closer collaboration with the various agencies (CDC, FBI, USDA APHIS, etc.) in formulating and carrying out the regulation would be appreciated. At one point, when the CDC was contacted for the name of a contact at the Federal Bureau of Investigation regarding background checks, no one could provide that information.
We appreciate this opportunity to provided input on this program.
Stefan Wagener, PhD, RBP, CBSP (ABSA)
President, American Biological Safety Association (ABSA)
Stefan Wagener, PhD, RBP, CBSP, President, ABSA - Comments Regarding Operational Issues of the CDC Select Agent Program, American Biological Safety Association (6 April, 2004),