Straight Talk from FSMA regulatory advisors Elizabeth Fawell and Maile Hermida of Hogan Lovells U.S. LLP
In the previous FSMA Files column, we covered FDA’s recent announcement to exercise “enforcement discretion” for certain FSMA provisions. To recap, this means compliance will not be required for a few of the FSMA provisions that had initially been outlined, even though they will technically remain on the books. For the almond industry, these updates apply to:
- The written assurance requirements in the Produce Safety, Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF) and Foreign Supplier Verification Programs (FSVP) rules.
- Facilities that would otherwise be considered farms, except for the ownership criterion.
- Facilities engaged in low-risk activities for byproducts that will become animal feed.
Please click back to the previous column to find more information regarding these updates.
As you consider new enforcement discretion and evaluate whether it applies to your operation, it is important to bear in mind some key points:
- FDA plans to engage in future rulemaking on these issues. While rulemaking is a slow process, the exercise of enforcement discretion is a temporary measure that allows FDA to signal its changed position on these issues in advance of completing a rulemaking. For now, these rules remain on the books, but FDA is not enforcing them. In the meantime, the Almond Board remains engaged on these issues.
- Even if FDA is not enforcing a requirement, you still remain subject to the general prohibition on adulteration. Remember that FDA considers food to be adulterated if it is manufactured, packed or held under unsanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health.
- Registration requirements remain in effect. Operations that meet the definition of “facility” are still facilities at this time, even if subject to enforcement discretion under the PCHF and PCAF rules, and still must register with FDA.
Produce Safety Training
Calling all growers! Have you completed your Produce Safety training? This course will provide a foundational overview of the FSMA Produce Safety Rule and give you the tools you need to be compliant. Contact Jayme Puthoff at jputhoff@almondboard.com or (209) 343-3279 for information on course dates and locations.
New resources to help the almond industry stay ahead on FSMA are now available on the grower and processor webpages.
Please keep your questions coming! You can send them to Tim Birmingham at tbirmingham@almondboard.com with the subject line “FSMA Files.”
This column was prepared by Elizabeth Fawell and Maile Hermida, who are lawyers with Hogan Lovells U.S. LLP in Washington, D.C. The FSMA Files column is provided for informational purposes only and does not constitute legal advice.
