By Charles Breen, Independent Advisor for FSMA
Those closely watching FSMA compliance dates will note that July 26, 2018 marks a significant date for FSVP and the Produce Safety Rule. Specifically,
- importers with Small Business Foreign Suppliers will now be required to comply with sprout requirements of Produce Safety Rule;
- importers with Small Business Foreign Suppliers that are farms producing sprouts are eligible for a Qualified Exemption under the Produce Safety Rule; and
- importers with Large Foreign Suppliers are required to comply with Produce Safety Rule;
with an exception for importers of food contact substances who now have an additional two years to comply with the FSVP requirements.
FDA is postponing an enforcement regarding written assurances in certain cases when a manufacturer/processor does not control a hazard requiring a preventive control. Originally, an additional two years to comply with the above specific requirements were to be granted based on written assurances from their customer that they will either manufacture the food in accordance with applicable food safety requirements or sell only to someone that agrees to do so. Sellers must notify commercial customers that hazards are not controlled, but sellers do not now need to obtain written assurances from customers as a condition of sale. FDA says in this context, “customer” does not mean “consumer.”
FDA provided a decision tree to assist affected firms in their understanding of the details for enforcement discretion of the written assurances provisions.
What does all this mean for your business? Plenty – particularly in light of the recent food safety outbreaks of Listeria monocytogenes which illustrate that even when preventive controls are applied, food emergencies can still occur. Managing a safe food supply requires serious vigilance at all times. Unfortunately, even the most diligent will likely see, at some point, some type of food safety event requiring immediate action, whether it is an unsanitary method of transportation, storage or production, worker hygiene, use of contaminated water or a large number of additional factors.
As part of the Produce Safety Requirement, you may recall our January 2018 FSMA Perspective which discussed the agricultural water testing and safety requirements. After much industry feedback that the numerical criteria for microbial water quality in the final rule are too complex, FDA issued a proposed rule to extend the compliance dates for the agricultural water requirements for produce other than sprouts. If finalized, the earliest compliance date for most agricultural water provisions would be January 2022 for the largest farms. Once finalized the specific requirements with regards to water testing leave no room for interpretation as to what constitutes a safe supply and FDA will request access to water testing data history for their own assessments of safety. Of course, prior to finalization, agricultural entities would be wise to begin or continue documented monitoring to gain a complete understanding of water quality used for irrigation and worker hygiene in order to provide FDA required data at the time of an inspection. Even though enforcement of FDA’s agricultural water provisions has been pushed back, they should still be considered a suitable benchmark for testing purposes. Any results found to be out-of-specification (OOS) should be retested followed by an assessment and correction of procedures leading to those OOS results.
Firms should also take a look at their entire organization’s policies and procedures, including the very important, and required by FSMA, training. Employees must understand what is required of them and why, and it is management’s responsibility to ensure that all required training is conducted in a language and manner that employees understand. This may mean conducting various types of training in a variety of languages.
Look closely at operations to assess whether they are meeting the requirements of the Produce Safety Rule. Start thinking: What training do we need? What may we have to adjust in our work processes to meet FDA’s standards?
An audit of all practices is a good idea in order to get an accurate picture of how current operating procedures match FSMA requirements allowing for the identification of needed improvements, planning, and execution. Additionally, some buyers require private audits (which may or may not have the same standards as FSMA requirements) so being able to demonstrate results from internal and/or third-party audits or mock-FDA inspections can only enhance one’s demonstration of efforts to meet or exceed standards.
In short, the compliance date for the Produce Safety Rule is right around the corner for importers with large business foreign suppliers as well as some small. It is always the right time to assess one’s current status and plan for improvements, though as FSMA continues to take shape and enforcement dates move forward, the urgency has never been greater.