FDA has revealed its draft budget request for Fiscal Year 2013. Unsurprisingly, there is a significant bump in the budget, given all FDA needs to do in order to implement FSMA. What is surprising is FDA’s request for a Food Establishment Registration Fee of $500 per facility. Those following the competing food safety bills in Congress in 2009 and 2010 will recall that the House’s bill originally funded activities through substantial user fees. The Senate’s version of the bill, which ultimately became FSMA, stripped out that provision. More excellent commentary on this budget from Dr. David Acheson is available on the Leavitt Partners’ Blog.
This week FDA released its proposed new rule on Records Access along with updated draft guidance document regarding the rule. The rule updates the existing regulations and guidance to note FDA’s expanded access to records in certain circumstances under FSMA. Under the Bioterrorism Act, FDA already had expanded records access under Class I recall-type situations; the rule expands access to records for other products reasonably likely to be similarly affected (e.g. if Salmonella is found in a finished product in product line A, FDA may have access to records for product line B if it has a reasonable belief product line B products are similarly affected). The interim rule and draft guidance document are available on FDA’s FSMA website.
This is just a taste of what is to come. We expect to see additional rules and guidance on recordkeeping requirements and records access provisions as FDA continues to implement FSMA. Questions on what records you need to be keeping or what sort of records FDA may access during an inspection? Contact Sarah Brew or another member of our Food Litigation and Regulatory Team.
According to the most recent quarterly report released by Stericycle ExpertRECALL Index, food recalls increased over 50 percent in the fourth quarter of 2011 and almost 55 percent over the same quarter in 2010. Half of the fourth quarter recalls were Class I, and another 40 percent were Class II. Allergen concerns remained the primary cause of the food recalls, making up over 100 recalls announced by FDA, while the second leading cause was potential Listeria contamination. Potential Salmonella contamination was the third leading factor in initiating recalls, representing 18 recalls. In contrast, medical device recalls decreased by more than 60 percent and pharmaceutical recalls declined by 35 percent in the same quarter.
You can access the full Fourth Quarter 2011 Recall Index here:
http://www.expertrecall.com/wp-content/uploads/Quarter-Four-ExpertRECALL-Index.pdf
Or to view the fourth quarter food recall report summary, use the following link:
http://www.expertrecall.com/wp-content/uploads/Quarter-Four-ExpertRECALL-Index-Food.pdf
These statistics are consistent with a recent analysis of Reportable Food Registry reports, which showed undeclared allergens as one of the top reasons for such reports. They underscore the importance of supply chain management for allergens, ensuring your labeling is compliant, and instituting CGMPs to avoid allergen contamination on shared product lines or in shared facilities. Our food industry specialists regularly assist in reviewing and advising on food safety programs, labeling, and supply chain risk management. Please contact Sarah Brew for more information.