The Council on Governmental Relations (COGR), representing over 200 U.S. research universities and affiliated institutions, submitted feedback to the Centers for Disease Control and Prevention (CDC) regarding the Notice of Proposed Rulemaking on the Possession, Use, and Transfer of Select Agents and Toxins, and its biennial review of the select agents list. COGR supports the proposed removal of Brucella abortus, B. melitensis, and B. suis from this list, emphasizing the positive implications for advancing research in vaccine development, diagnostics, and control measures. However, the organization raises substantial concerns about the breadth and ambiguity of the proposed definition of "release," arguing that its vagueness could impose undue administrative burdens through unnecessary reporting of non-hazardous incidents, complicating compliance and potentially deterring transparent internal reporting of safety lapses.
COGR also comments on exemptions and training requirements in the NPRM. It encourages expanding the laboratory exemptions under 42 CFR Section 73.6 to specifically include research laboratories, not only clinical or diagnostic ones. Furthermore, it critiques the vagueness in the proposed training requirements for personnel who may be in proximity to select agents or who fulfill related administrative functions, recommending more precise and pragmatic language to ensure clarity in compliance and implementation. COGR concludes by reaffirming its commitment to effective regulation that balances safety with practicality, advocating that its recommendations will support both compliance and public protection without imposing unnecessary burdens.
