Straight Talk from FSMA Advisors Elizabeth Fawell and Maile Hermida of Hogan Lovells U.S. LLP
You may have heard about changes to the FDA’s calendar for the implementation of the FSMA Produce Safety rule. Yes, yet again! Most notably, the FDA has 1) proposed extending the compliance dates for the agricultural water-related requirements of the rule by 4 years and 2) delayed the start of Produce Safety rule inspections. In this month’s column, we’re breaking down what this news means for you.
Update #1: You Will Likely Have More Time to Meet Produce Safety Agricultural Water Compliance Dates
Why? FDA is proposing an extension to this action so it can take more time to reevaluate the feasibility and practical implications of the water standards. FDA has proposed extending the compliance dates for the agricultural water requirements as follows:[1]
- Very small business ($25,000-$250,000 annual sales): January 26, 2024
- Small business ($250,001-$500,000 annual sales): January 26, 2023
- All other businesses (>$500,000 annual sales): January 26, 2022
Almond Board of California submitted comments in support of the proposed extension.
Update #2: Produce Safety Inspections Have Been Delayed Until Spring 2019
Why? Input from farmers and state regulators has proven that more time is necessary to ensure farmers have the training and information needed to comply and that states are able to establish strong produce regulatory programs before inspections begin.
Note: It’s important that farms work toward Produce Safety compliance despite this delay. Even though FDA will not be conducting routine inspections, the agency can still take action if necessary to protect public health.
Still feeling confused? Almond Board of California is here to help and has developed several new resources to help you get up-to-speed on all things FSMA. Check them out on the grower (almonds.com/growers/fsma) and processor (almonds.com/processors/fsma) 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, DC. The FSMA Files column is provided for informational purposes only and does not constitute legal advice.
[1] Under the final Produce Safety rule there were two sets of compliance dates for the agricultural water requirements. FDA is proposing to simplify the compliance period structure so that all the compliance dates for these provisions occur at the same time, based on farm size.
