With Draft Food Safety Legislation, Heavy Burdens All Around

By Ricardo Carvajal –

Much ink has already been spilled detailing the burdens that draft federal food safety legislation would impose on industry (click here for the latest version of the  Food Safety Enhancement Act of 2009 (“FSEA”)).  Little has yet been said about the burdens that the legislation would impose on FDA.  A quick tally suggests that FDA would be required to issue or amend six regulations, and perhaps as many as ten (some provisions give FDA the option of issuing a guidance document instead of a regulation).  FDA would be given discretionary authority to issue or amend four additional regulations (perhaps as many as eight).  In addition, the legislation would impose continuing reporting requirements on FDA in several areas.  All of these burdens are in addition to those that would result from the aggressive inspection schedule that the legislation would impose on the agency.

The draft legislation’s rulemaking and other requirements would surely soak up substantial resources within FDA.  To gauge their potential impact, one need look no further back than 2002, when the rulemaking requirements associated with the Bioterrorism Act appeared to derail a number of the agency’s other food-related initiatives.  Even with substantial increases in funding, a similar outcome seems likely if FSEA passes in anything resembling its current form.