FSMA Friday: December 2019 FSMA Updates, Recent FDA Activities & Reflections on 2019

As 2019 came to a close, a couple of new FSMA developments emerged. For one, the FDA proposed a rule in regards to Section 202 of FSMA, which would require the use of an accredited lab for eligible facilities. For instance, upon receipt of a 483 notice, facilities could be required to go through an accredited lab when performing finished product and zone 1 contact surface testing to control risk. It’s also possible this rule could give the FDA the authority to request data from lab results as soon as they’re available, which would have a significant impact on the industry.

There are also recent industry-wide developments which may suggest patterns that will develop for the decade ahead. For one, the FDA has ramped up their produce testing efforts to embark on the enforcement of the Produce Safety Rule more aggressively. And, now that FSMA inspections are underway, the number of 483s which have been issued around Foreign Supplier Verification Programs (FSVP) suggests that the agency is dedicated to the enforcement of this rule as well. It’s therefore essential for importers to ensure their FSVP is robust and complete.

Additionally, while GFSI audits have long been used as the third-party audit for compliance with FSMA’s supply chain control program (required for class 1 level risks), there have been instances in which inspectors have deemed this approach inadequate. While there is nothing inherently wrong with using the GFSI audit, it must specifically address the risk that was found during the risk assessment for the supplier. For instance, if salmonella is identified and the supplier is relied upon to control the risk, a generic GFSI audit in itself may not show how they’re controlling the salmonella risk. As FSMA inspections accelerate, companies that have identified class 1 level risks will need to look at these factors carefully to ensure they’re being addressed properly.