Biodefense Law and Opinion

            The CDC regulation of biodefense work has been criticized for the onerous burden it places on individual biodefense researchers and institutions and the unworkable requirements, all in the name of biosecurity and biosafety; and these regulations would not have prevented, or even led to the discovery of a Dr. Bruce Ivins, if he had worked in a civilian biodefense laboratory.

            These CDC regulations cover a range of possible threats to safety, involving transport, possession and use of “select agents”.  Select agents is the regulatory term for listed biological agents subject to these biosafety and biosecurity regulations.  The rules  apply to civilians in civilian laboratories, but do not apply to military institutions, such as the U.S. Army  Medical Research Institute of Infectious Diseases (USAMRIID), where Dr. Ivins worked.  However, a DOD regulation temporarily issued (in interim) around the same time as the civilian regulations, adopted the CDC requirements for FBI background investigations before the researcher can have “access” to the biological agents.  In addition, the Department of Defense which is responsible for USAMRIID, adopted its own, more extensive background investigation requirements. 

            The CDC background investigation regulation allows the denial or revocation of an investigator’s access “to any select agent or toxin to an entity or individual identified by the Attorney General as a ‘restricted person’ under 18 U.S.C. 175b.”   In summary, a “restricted person” is someone who could not meet the requirements to obtain a gun permit:  they cannot be under indictment for, or convicted of a felony; be a fugitive from justice; be an unlawful user of controlled substance; be unlawfully in the United States; be found mentally defective by a court; or have been dishonorably discharged.

            However, for biodefense researchers like Dr. Ivins, the DOD background investigation requirement is much more extensive, has much higher threshold standards and also adds the CDC, FBI background investigation requirement.   Specifically, USAMRIID researchers must be “mentally and emotionally stable, trustworthy, and physically competent.”  Mandatory disqualifying factors include “attempting or threatening suicide while currently enrolled” in the program as a researcher, or “individuals who have attempted or threatened suicide before entry into” the program and require the certifying official to revoke access to the researcher who meets any of those criteria.  Even “inappropriate attitude or behavior” including, “aberrant behavior such as impulsiveness, suicide threat, or threats toward other individuals,” are mandatory factors for disqualification and barring the individual from work.

           A civilian institution researcher has only to meet the requirements of a FBI background investigation that comprises nothing greater than meeting the requirements for a gun permit; yet DOD has these significantly greater additional military regulations for access.  We have to ask if the right regulatory mechanisms have been selected to protect public health and national security.  Is it time to rethink our regulatory framework for our nation’s biodefense research, and focus more effort on fully implementing the background investigation requirements, better perimeter security, and less focus on filling out forms, filing reports and counting units of self-replicating organisms?   But CDC has chosen to regulate with what they are familiar --- living organisms and safety.  They are also charged with biosecurity, an area with which they are unfamiliar, and does not fit the expertise of the agency. 

             A regulation that is so filled with requirements that are time-consuming and unworkable, designed to fit the talents of the agency, rather than the needs of the societal regulatory intervention may very well prove the perfect distraction for opportunities to misuse biological agents.