With New Food Safety Law, Significant Burdens on Industry (and on FDA)

By Ricardo Carvajal –

The Food Safety Modernization Act ("FSMA") is now law.  We previously blogged on some provisions that take immediate effect (namely stronger records access authority under FDC Act § 414, mandatory recall authority, whistleblower protection, and authority to refuse admission of imported food from a facility that refuses inspection).  Other provisions that enhance FDA’s existing authorities but will take time to implement include suspension of registration, lower threshold for administrative detention, and import certification. Still other provisions will impose or authorize FDA to impose significant ongoing burdens on industry, most notably mandatory HACCP and associated recordkeeping requirements, additional recordkeeping requirements for high risk foods, compliance with performance standards and produce safety standards, implementation of measures to protect against intentional adulteration, verification of foreign suppliers’ compliance with U.S. law, and payment of reinspection fees.  We plan to spotlight these provisions as their effective date draws nearer. 

For now, it’s worth revisiting an issue we raised with respect to the FSMA’s companion bill, the Food Safety Enhancement Act – namely that of burdens imposed on FDA.  The FSMA directs FDA to substantially increase the number and frequency of domestic and foreign inspections.  Further, by our estimate, the FSMA directs FDA to engage in 10 rulemakings, issue no fewer than 10 guidance documents, prepare 13 reports (some on a recurring basis), and engage in numerous other resource-intensive implementation activities.  The burdens that these directives will impose on multiple components within FDA should not be underestimated.  In the absence of commensurate funding, it seems likely that the law will not be fully implemented and that numerous other food-related agency initiatives could once again find themselves on the back burner.  This type of discrepancy between increased agency responsibilities and the level of funding needed to fulfill those responsibilities has been identified as a cause of under-performance at FDA, such that a coalition of consumer and professional groups and trade associations (including a number of food trade associations) joined forces in the Alliance for a Stronger FDA to pressure Congress for additional agency funding.  The need for adequate funding to implement FSMA has already been acknowledged by the FDA Commissioner in her statement on the FSMA’s significance.  Whether FDA can buck the promised trend toward less government spending in 2011 and beyond will be one story to watch.