FSMA Files: Navigating FSMA Rules
Nov. 22, 2017
Interview with FSMA Regulatory Advisors Elizabeth Fawell and Maile Hermida of Hogan Lovells U.S. LLP
What is your top recommendation for an almond grower, processor or huller/sheller approaching the FSMA rules for the first time?
HL: Our first recommendation would be to spend some time determining if the FDA classifies you as a “farm” or a “facility,” as its determination might be different than how you view yourself. In addition, FSMA compliance will be different for each of these operations. Under FSMA, farms fall under the Produce Safety rule. Facilities (e.g., operations that manufacture/process almonds) are subject to the Preventive Controls rule. But it’s not always so black and white.
- For example, a huller/sheller (H/S) located adjacent to an orchard would be considered a farm. In addition, a H/S not located on a farm would still be considered a farm if the majority of the almonds it hulls/shells are under the same common ownership as the H/S. This would technically make the operation a secondary activities farm under the FDA’s “farm” definition, subject to the Produce Safety rule. Alternatively, an off-farm H/S that does not perform hulling and shelling on the majority of its own almonds would be considered a facility and subject to the Preventive Controls Rule.
- Or, you could identify as an almond grower, but if you also conduct certain other activities – such as roasting almonds – you would technically be recognized as a Farm Mixed-Type Facility, meaning you would need to comply with both the Produce Safety and Preventive Control rules.
Once you determine whether you are a “farm” and fall under the Produce Safety rule, or if you are a “facility” and fall under the Preventive Controls rule, you then need to ask yourself about the other activities you conduct to determine which other FSMA rules may apply. Once this is done, you need to look into compliance dates and possible exemptions for each rule.
Finally, we recommend that you stay connected with Almond Board of California (ABC). They’re working hard to provide you with background on resources that can help you make the best decisions for your farm. The ABC website, newsletters and various events are great ways to learn more about how you can manage FSMA compliance.
Let’s say I identify as an almond grower. What steps should I follow to determine my FSMA compliance requirements?
HL: If you grow almonds, you would be classified as a primary production farm and subject to the Produce Safety rule. Keep in mind, you must also look at any other activities your operation conducts to see if other FSMA rules may apply.
Go to the grower FSMA pages for an overview of the Produce Safety rule and to learn which compliance dates apply to you. For most growers, compliance will be required by January 2018.
Let’s say I am an almond processor that imports spices from a country outside of the U.S. to season my almonds. What steps should I follow to determine my FSMA compliance requirements?
HL: As an almond processor, you would be classified by the FDA as a “facility,” subject to the Preventive Controls rule. There is a requirement within the Preventive Controls rule to perform supplier verification of any ingredients, regardless of whether they are sourced domestically or internationally, if the supplier will be controlling the hazards identified in the ingredients. However, if the processor will be controlling the hazards, or the hazard will be controlled further down the supply chain, then supplier verification is not required.
If you source ingredients from a foreign country and are the “importer” of the ingredients at the time of entry, then you will also fall under the Foreign Supplier Verification Program (FSVP) rule. (Bear in mind that determining if you’re the FSVP importer can be rather complicated!) If you are the FSVP importer, so long as you have met your supplier verification obligations under the Preventive Controls rule, then you are “deemed in compliance” with FSVP; the only additional requirement would be to provide certain identification information at the border through the import filings. It is important to note that if you are receiving imported ingredients, but they are coming from a U.S.-based distributor, it is unlikely you are responsible under FSVP.
Go to the processor FSMA pages for an overview and detailed steps of the FSMA rules that may apply to you. Keep in mind, most compliance dates have already passed for almond processors.
Please keep your questions coming! You can send them to Tim Birmingham at email@example.com with the subject line “FSMA Files.”
ABC utilized input from Elizabeth Fawell and Maile Hermida, lawyers with Hogan Lovells US LLP in Washington, DC. in the preparation of this column. The FSMA Files column is provided for informational purposes only and does not constitute legal advice.