Comment from David Mills

I have a number of serious concerns with the proposed changes to the Select Agent Rule, as I fear that they will significantly and adversely impact the operations of public health laboratories unless further revised. The proposed changes take a "one size fits all" approach and do not discriminate between laboratories utilizing very small quantities for public health purposes vs. those facilities utilizing larger quantities of threat agents for different purposes. The threat to public safety from the former is much lower than the threat from the latter, as I believe is supported by the actual incidents that have occurred since the passage of the Select Agent rule. To meet the additional, unfunded requirements, public agencies will be required to fund items such as the personnel reliability program (PRP) by diverting resources from their public service operation budgets- staffing, supplies, instrumentation and training. This will further erode the functional capacity of the public health laboratories with no improvement to public safety. It would make more sense to focus the increases in requirements to those facilities (academic, research, defense, commercial) that have shown to be higher risk operations, sparing the public health laboratories from them. Furthermore, my understanding is that there is not a consensus that programs, such as Personnel Reliability Programs, are very effective. I strongly oppose the mandate that public health facilities be required to institute such programs. They are very expensive to do properly and are overkill for the level of risk associated with the public health laboratories.