The U.S. Food and Drug Administration (“FDA”), for the first time in its history, formally entered into regulating how food is grown and harvested by proposing standards for the safe growing, harvesting, packing, and holding of produce on farms. The Food Safety Modernization Act required FDA to establish minimum standards for minimizing the risk of serious adverse health consequences or death for producing and harvesting raw agricultural food products. The proposed rules have a comment period deadline of May 16th, 2013. What exactly do FDA’s proposed regulatory standards look like?
- They only require minimizing the risk of biological contamination (such as Salmonella, E. coli, and Listeria); they do not require minimizing the risk of chemical, physical, or radiological contamination.
- They do not apply to all produce. Exempted, for example, are asparagus, cranberries, potatoes, sweet corn, winter squash and other produce that is “rarely consumed raw.”
- They are general regulatory standards rather than specific rules for commodity categories (except, ‘sprouts’ has a specific standard). This is similar to the regulations for Food current Good Manufacturing Practices (“cGMPs”) and Hazard Analysis and Risk-Based Preventive Controls (“HARPC”). Once finalized, farms will have between two to six years to implement these requirements – the time allowed depends, generally, on the size of the farm.
Although FDA is new at regulating farms, it will make finalizing and implementing these requirements a high priority, because a significant number of major food outbreaks in the past have involved raw produce that was contaminated at the farms. Furthermore, we can expect FDA to issue guidance documents for the different commodities on exactly how FDA “recommends” producing and harvesting the commodity. Just like with the seafood HACCP guidance, we can also expect FDA to treat its guidance documents as a requirement and fault farms for not following the “recommendations.” Stay tuned to our blog for more on the proposed rules, especially as the May 16th, 2013 deadline approaches. If you would like our assistance in developing comments for the agency’s consideration, please contact us.
