OMB Approves Two Bioterrorism Rules

On Friday the Office of Management and Budget approved two rules dealing with the US bioterrorism prevention program, one from HHS/CDC and the other from USDA. Both rules deal with the biennial review of select agents and toxins.

Select Agent and Toxin List

The USDA rule would amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. It based on the relative potential of each select agent or toxin to be misused to adversely affect human, plant, or animal health implements the findings of the third biennial review of the list. The rule reorganizes the list based on the relative potential of each select agent or toxin to be misused to adversely affect human, plant, or animal health. This tiering of the list would allow for the risk-based structuring of security measures.

Security Measures

The HHS/CDC rule also updates the Select Agent and Toxin list based upon an interdepartmental review. It also implements the requirements of EO 13546, Optimizing the Security of Biological Select Agents and Toxins (BSAT) in the United States, to review, tier, and reduce the Select Agent List; establishing personal reliability standards for BSAT workers; and establishing physical security standards for identified Tier 1 select agents and toxins.

Not Homeland Security Related

The OMB makes one of the silliest statements that I have seen in a government publication in a long time in their action notice for each of these rules (HHS/CDC and USDA). On their standard notification format there is a question to be answered by OMB; “Related to Homeland Security”. In both instances the answer is “No”. The whole purpose of these two rules is to ensure that no one steals or diverts any of the select agents or toxins to be used as terrorist weapons. This is clearly established in  §3(a) of the Executive Order: “The use of BSAT presents the risk that BSAT might be lost, stolen, or diverted for malicious purpose.” And what better malicious purpose than a terrorist WMD attack.

The only thing that I can figure is that someone at OMB is making a simplistic response to that question; since the rule was not filed by DHS, then it couldn’t be related to Homeland Security. Needless to say that would be the height of bureaucratic simplemindedness. Hopefully this mistake was one made by an administrative minion not someone with decision making authority.

Moving Forward

Both rules were approved ‘Subject to Change’ so I suspect that there will be a little time lag for those ‘minor corrections’ required by OMB to be made to the documents. Typically these take a couple of weeks, but that would mean that they would be published in the Federal Register during the ‘October Surprise’ period of a presidential campaign. If the politicians at the White House feel that there is anything even slightly controversial in these rules, I would suspect that they would be further delayed until after November 6^th; no sense giving the opposition any unnecessary ammunition in a very close election.

BTW: I hope that HHS/CDC does a better job of writing risk-based security performance standards than DHS/ISCD did.