Straight Talk from legal advisors Elizabeth Fawell and Maile Hermida of Hogan Lovells U.S. LLP
FDA recently announced it will exercise “enforcement discretion” for certain FSMA provisions. Translated, this means compliance will not be required for a few discrete FSMA requirements, even though they will technically remain on the books.
The areas relevant to the almond industry are:
- The written assurance requirements in the Produce Safety rule, Preventive Controls for Human Food (PCHF) rule, Preventive Controls for Animal Food (PCAF) rule and Foreign Supplier Verification Programs (FSVP) rule;
- The PCHF and PCAF rules for facilities that would otherwise qualify as “secondary activities farms” if not for the ownership of the facility; and
- Compliance with the PCAF rule for facilities that engage in certain limited manufacturing activities on human food by-products that will be sent to animal food.
Written assurance requirements
FDA will exercise enforcement discretion for the written assurance provision under each of the four major FSMA regulations (PCHF, PCAF, Produce Safety, and FSVP).
Here are the key points you should know:
- Operations (Almond Growers and Huller/Shellers) no longer need to receive written assurances from customers that the customer (or the customer’s customer) is controlling the hazard. This is significant because it eliminates one of the requirements necessary to satisfy the “commercial processing exemption,” which provides farms with an exemption from all requirements in the Produce Safety rule.
- Operations still must make written disclosures to customers. The requirement to make written disclosures to customers remains in effect, and FDA will enforce it. This means that operations must disclose that “almonds are not processed to adequately reduce the presence of microorganisms of public health significance.” This disclosure must be made in “documents accompanying the food, in accordance with the practice of trade…such as labels, labeling, bill of lading, shipment-specific certificate of analysis, and other documents or paper associated with the shipment that a food safety manager for the customer is likely to read.”
Facilities that would otherwise qualify as farms
FDA will also exercise enforcement discretion for compliance with the full PCHF and PCAF rules for facilities that would otherwise qualify as secondary activities farms, except for the ownership requirement (i.e., an operation, not located on or majority-owned by a primary production farm, that is devoted to harvesting, packing and/or holding raw agricultural commodities (RACs)).
Here are the key points you should know:
- The exemption applies to facilities solely engaged in packing and/or holding activities on nut hulls and shells (e.g., Non-Farm Huller/Shellers, brownskin facilities) as well as to “farm mixed type facilities.” The exemption does not apply to manufacturing operations (e.g., chopping, roasting, packaging).
- Operations exempt from the PCHF and PCAF rules under this enforcement discretion are still considered “facilities” and must register with FDA.
- However, FDA intends to initiate rulemaking for some entities that conduct farm-related activities, potentially reclassifying these operations as “farms.”
- The exemption applies to preventive controls requirements in both the PCHF and PCAF rules, and the GMPs in the PCAF rule. Current exemptions from human food GMPs for “establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing)” and “establishments solely engaged in the holding and/or transportation of RACs” also still apply.
Human food by-products for use as animal feed
FDA has announced it will not enforce the animal food preventive controls requirements for human food facilities that are subject to and in compliance with human food GMPs if the manufacturing/processing activities performed on the human food by-products for use as animal feed are limited to the following:
- Drying/dehydrating, evaporating, pressing, chopping and similar activities to reduce weight and volume, and/or
- Mixing (e.g., combining different vegetable culls and trimmings, combining juice and dairy-products, stirring), centrifuging and similar activities to combine ingredients or separate components (e.g., water and solids), and
- These activities are not performed to prevent or significantly minimize animal food hazards and do not introduce animal food hazards.
The following are additional points to keep in mind with respect to FDA’s enforcement discretion:
- Operations that fall within the enforcement discretion still must comply with the limited holding and distribution GMPs for human food by-products that are used for animal food.
- Facilities that perform heating or cooling to address pathogens, pelting, extruding and formulating of human food by-products are conducting manufacturing activities and are not covered by the enforcement discretion.
Calling all growers! Have you completed your Produce Safety training yet? This day-long course will provide a foundational overview of the FSMA Produce Safety rule and help set you up for success. 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 get up-to-speed 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.
