FSMA Files: Straight Talk from the Experts

Welcome to the first edition of our new FSMA Files column! We’ll use this column to provide you with easy-to-understand answers to your Food Safety Modernization Act (FSMA) questions. With so much FSMA chatter these days, sometimes it’s hard to know where to turn to get clear, accurate information. Our goal is to make FSMA understandable and cut through all of the noise.

This column is prepared by attorneys Maile Hermida and Elizabeth Fawell, who are consultants to Almond Board of California (ABC) on FSMA issues. Based in Washington, D.C., with the global law firm Hogan Lovells, Hermida and Fawell are “food lawyers” who have worked on FSMA since the very beginning. In fact, Fawell was involved back when the legislation was being drafted on Capitol Hill. Both consultants were extensively engaged with FDA during the multi-year rulemaking process and prepared more than 100 comments to the agency.

A large large part of Hermida and Fawell’s work now involves advising companies on what FSMA means for their businesses, helping them to develop compliance strategies, and providing strategic advice on public policy issues. To that end, ABC has retained them to help navigate the complex maze of FSMA compliance for the California Almond industry. Some of you may already know them, as they have been working with ABC for a few years, have visited almond operations throughout the supply chain, and presented at both the Almond Quality and Food Safety Symposium and The Almond Conference. The two lawyers understand the industry and FSMA first-hand. In this FSMA column, they will apply that knowledge to help answer questions or concerns you may have around which rules may apply to your operation, and offer tips on how to comply.

FSMA Q&A by Maile Hermida and Elizabeth Fawell 
When you ask us FSMA questions, our goal is both to provide you with an answer in plain language and to give you the supporting explanation, in case you need to dive deeper. You’ll see our unique approach in the questions and answers below. We strive to provide more direct and timely responses than you’ll receive if you submit questions to FDA through its Technical Assistance Network (TAN) advice portal.

Since this column is written by lawyers, we can’t get by without a few important disclaimers.  First and foremost, this column is provided for informational purposes only and does not constitute legal advice. We are not acting as your lawyers in preparing this column. If you have legal questions, we encourage you to work with us directly or with your legal counsel.

We hope you’ll find this column to be a useful resource. Feel free to send your questions to Tim Birmingham at tbirmingham@almondboard.com with “FSMA Files” in the subject line. Check future issues of The Handle to see our responses.

Now for our first questions!

Question: Do almonds processed for export need to comply with the Preventive Controls rule?

Straight Talk: No. The Preventive Controls rule only applies to food intended for consumption in the United States. This is different from how the Produce Safety rule works, as discussed in the next question below.

Explanation: The Preventive Controls rule only applies to “registered facilities.” A facility is not required to register with FDA if it does not manufacture, process, pack or hold food for consumption in the U.S. Following that framework, if a facility has some operations that relate to food for U.S. consumption and some operations that relate to food for foreign consumption, the Preventive Controls requirements only apply to the food for U.S. consumption. That being said, if a facility produces food for both domestic and foreign consumption, the aspects of the operation related to foreign consumption could become relevant to Preventive Controls compliance if they could affect the safety of the U.S. food. For example, if treated almonds for U.S. consumption are on an adjacent line to untreated almonds for export, this could affect the safety of the treated nuts; therefore FDA would likely want to see controls in place that relate to the exported nuts to protect the safety of the U.S. food. Also, even though the Preventive Controls rule doesn’t apply, note that there are other FDA regulations governing food for export that would apply, such as requirements concerning labeling the food and ensuring it meets the requirements of the country for which it is intended.

Question: Do almonds grown for export need to comply with the Produce Safety rule?

Straight Talk: Yes. All produce grown in the U.S. needs to comply with the Produce Safety rule (unless it falls under an exemption, such as if it will be subjected to commercial processing downstream or it’s grown by a farm with under $25,000 in average annual produce sales — See “Silver Lining” below for exemption information). This is different from the way the Preventive Controls rule works, as discussed in the above question.

Explanation: The Produce Safety rule explicitly states that it applies to all produce grown domestically, regardless of whether it is for domestic or foreign consumption. The regulation states: 

“Unless it is excluded from this [regulation], food that is produce ... and that is a raw agricultural commodity (RAC) is covered by this [regulation]. This includes a produce RAC that is grown domestically and a produce RAC that will be imported or offered for import in any state or territory of the United States, the District of Columbia or the Commonwealth of Puerto Rico.” 21 C.F.R. § 112.1(a). (See also 80 Fed. Reg. at 74386.)

This means that, in order for the produce to qualify as exempt from the rule, the written disclosure and written customer assurance provisions for produce that will receive commercial processing downstream apply to exports as well.

Silver Lining: ABC has been engaged with FDA on what a grower exemption would look like.  Based on ABC understanding (and recognizing we do not have written confirmation from FDA on this approach), an exemption may be possible if:

  1. Growers provide written disclosure that almonds are not processed to adequately reduce the presence of micro-organisms of public health significance, and;
  2. Handlers provide a written assurance to the grower that almonds will be treated in accordance with the requirements under the mandatory program for Salmonella reduction on almonds, or otherwise will be exported with a disclosure that they are not processed to adequately reduce the presence of microorganisms of public health significance and should be treated in accordance with the regulatory requirements of that country, with such written assurances provided by the customer.

Question: Can companies set up separate facility registrations for the different types of operations performed on the same campus, so that they can take advantage of the compliance date extension for facilities “solely engaged” in packing or holding nut hulls and shells?

Straight Talk: No. FDA has made it clear all operations owned by the same party and performed at the same general location fall under the same facility registration.

Explanation: It would not be possible to obtain separate facility registrations for these different operations unless the ownership was different. That is because of the way FDA has defined “facility” for purposes of facility registration, which is: 

“Facility means any establishment, structure or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs or holds food for consumption in the United States. A facility may consist of one or more contiguous structures, and a single building may house more than one distinct facility if the facilities are under separate ownership.”

Even if this business has different structures engaging in different activities, it would still be considered one facility if the ownership is the same. Therefore, it could not register the operations separately to take advantage of the extended compliance date, based on the present ownership scenario.

Please keep the questions coming! 


The Handle