2019 Produce Compliance Dates for FSMA

By Charles Breen, EAS Independent Advisor for FSMA Consulting Services

January 28, 2019, marks the compliance date for four categories of produce growers:

• Sprouts from Very Small Farms (with certain exemptions), 
• Sprouts from Very Small Farms eligible for a qualified exemption to comply with other requirements in 112.6 and 112.7, 
• Other small farms, (except those with certain water requirements), and 
• Small Farms eligible for a qualified exemption to comply with other requirements in 112.6 and 112.7

must come into compliance.

FSMA’s Final Rule on Produce Safety, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, and FDA’s helpful Small Entity Compliance Guide concerning determination of business size (based on annual monetary value of the food farms sell directly to qualified end users) are two important resources for farms growing and harvesting produce for consumption without further processing.

Recent foodborne illness outbreaks from romaine lettuce illustrate why it is prudent to take a fresh look at some specific areas where the introduction and harboring of pathogens can wreak havoc and cause devastating public health and economic consequences.

FDA’s recently announced that the list of possible growing areas identified as the source of the E. coli outbreak in romaine lettuce has been narrowed to three California counties, and one farm in particular. However, FDA concedes that this does not explain all of the illnesses. As of December 13, 2018, traceback information from five restaurants in four states have identified 11 different distributors, nine different growers, and eight different farms as potential sources of the contaminated lettuce, so it is likely that the outbreak cannot be explained by a single farm, grower, harvester, or distributor. FDA continues to investigate.

It’s also not only E. coli causing produce industry woes. Listeria monocytogenes prompted recent recalls of pre-packaged salad products and asparagus, as did a summer outbreak of Cyclospora in melons and lettuce. 

Why are these events continuing to happen? FSMA’s many requirements were designed to prevent just such occurrences. Are growers not complying with the regulations because they are too difficult to understand, or too difficult to follow? Or are these outbreaks examples of Murphy’s law, that no matter the risk mitigation strategy, if something can go wrong, it will?

The answer, in my view, is yes to all three – and I’ll add that sometimes downstream consequences are not fully understood until it is too late. 

Take for instance, this past summer’s E. coli outbreak in romaine lettuce. The fact that after so many months FDA still cannot pinpoint the exact source of the outbreak suggests these companies and areas under investigation appear (at least on the surface) to be largely in compliance. As of this writing, Whole Genome Sequencing testing has identified only one result where an agricultural water reservoir sediment contains the same E. coli O157:H7 strand implicated in the outbreak. However, the agency says it isn’t clear how the water became contaminated and that additional illnesses demonstrate that this reservoir cannot be the only cause of such a widespread outbreak. 

As compliance dates for various sized produce and sprout farms arrive, FDA will continue to transition from an educational to a regulatory approach for FSMA and supplier enforcement. Prudent companies will take a step back and review their supplier, manufacturing, agricultural and transportation protocols to ensure that all conceivable entry points for microbiological, chemical and physical hazards are controlled, and, when problems do occur, quickly testing entry points to identify and reduce impacts.

Just because something hasn’t yet happened at your facility doesn’t mean it won’t, and don’t assume that just because something happens at one of your suppliers or distributors, that your company won’t see negative repercussions. Food safety is everyone’s business.

EAS stands ready to help you with all aspects of FSMA compliance. Contact us or more information end-users and we invite you to view our many industry information sheets to learn more about our services with regards to foods, FSMA and other FDA requirements for all product areas.

Posted in EASeNews, Foods, FSMA Perspective and tagged Charles Breen.