FDA Updates Proposed Rules Under the FSMA

September 26, 2014 by
On January 4, 2011, President Obama signed into law the Food Safety Modernization Act (FSMA).  The primary purpose of the FSMA is to provide the FDA with the tools and authority to focus on preventing food safety issues from arising rather than simply reacting to problems after they already occur.  Although enacted in 2011, the FSMA is being implemented over time.  The FDA is tasked with issuing a number of rules and, since 2011, has proposed seven rules to implement the FSMA.  The FDA has now updated four of those proposed rules to reflect feedback and comments received from the public following the issuance of the original proposed rules.
One of the key updates relates to the proposed rule regarding preventive controls for human food.  Specifically, farms that pack or hold food from other farms are no longer subject to the preventive controls rule and would not be required to register as a food facility.  The update also revises the definition of "very small business" to include businesses having less than $1 million in total annual sales of human food.  Further, the FDA is seeking comments as to whether facilities should be required to conduct (1) product testing to verify implementation and effectiveness of preventive controls and (2) environmental monitoring to verify implementation and effectiveness of preventive controls if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard. 
The FDA is also proposing changes to the rule for produce safety.  The update revises the microbial standard for water that is directly applied during the growing of produce.  Farmers with agricultural water that does not initially meet the proposed microbial standard would have additional means by which they could meet the standards and be able to use the water.  One such option would be to implement a sufficient interval of days between irrigation and harvest.  This would allow potentially harmful microbes to die.  The FDA explained that a number of commenters suggested that the FDA rule should allow for microbial die-off that occurs naturally and believes this update provides the necessary flexibility.  Finally, the FDA, recognizing that different water sources have different levels of contamination risk, is proposing a tiered and more targeted approach to testing each source of untreated water that will be less burdensome on farmers but still protecting the public health.
Additionally, the FDA is revising the rule for foreign-supplier verification to provide importers with more flexibility to determine appropriate supplier verification measures based on risk and their own previous experience with suppliers.  The fourth rule being updated deals with preventive controls for animal food that would make current good food manufacturing practice regulations more applicable to animal food. 
The comment period for these proposed revisions will open on September 29, 2014, and will remain open for 75 days.  During that time, the FDA will continue to review comments already received on the original rule.  However, the FDA will not accept any additional comments on the original rule.  

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