From The Editor | June 27, 2017

Unfinished Business: Answering Your Questions About FSMA's Food Defense Rule

Sam Lewis

By Sam Lewis

Be sure to watch the entire web chat or read part one, part two, and part three of this series

Food Online hosted a live web chat, Food For Thought: FSMA’s Food Defense Rule, featuring Clay Detlefsen, VP of regulatory affairs and counsel at the National Milk Producers Federation (NMPF); and Warren Stone, senior director of science policy, compliance, and inspection at the Grocery Manufacturers Association (GMA). In this 45-minute live Q&A, Detlefsen and Stone answered the audience’s questions about FSMA’s Food Defense Rule. While the session was educational and informative, there wasn’t enough time to answer every question. Here, Detlefsen and Stone address the unanswered questions from the live web chat.

Food Online: John is asking, “Has the FDA completed FSMA training for all of its inspectors? Can we expect to see multiple inspectors arriving at our facilities for training purposes?”

Detlefsen: Food defense training for industry and inspectors has not begun. Training for other rules is ongoing.

Stone: Training courses for the IA rule have not been completed yet. You may see them in the fall of 2018.  

Food Online: Laurie, Robert, Olivia, and Jose asking about compliance dates. Specifically, “What are the general compliance dates? Is there one coming up in July of 2017?”

Detlefsen: Very-small companies will need to comply in five years (September, 2021). Small businesses will need to comply in four years (September, 2020). All other businesses will need to comply in three years (September, 2019). There are no compliance dates in 2017 or 2018.

Warren Stone: General compliance deadline for companies with over 500 employees and $10 million in sales is September 2019.

Food Online: John was wondering if you could offer a few bullet points on creating an effective Food Defense plan.

Detlefsen: Follow the process in the FDA food defense plan builder tool, follow the food defense guidance when issued, and get the necessary training through the Food Safety Preventive Controls Alliance when it is offered. Above all, use your common sense when putting your plan together.

Food Online: Lance said, “I did not see an exemption of the rule for seafood processing. Could you explain what’s expected from that industry?”

Stone: Processors covered by Juice and Seafood HACCP must comply with the Intentional Adulteration rule.

Detlefsen: Warren’s response is correct; Processors covered by Juice and Seafood HACCP must comply with the Intentional Adulteration rule.

Food Online: Tom asked, “Is there a simple template to start building the Food Defense Plan available? Specifically one for retail feed mills?”

Stone: Not per se, but you should check out the Food Defense Plan Builder available on the FDA website. Remember, version one will probably not achieve compliance with the rule, but the soon-to-be-released version two should do that.

Food Online: Michael is asking, “Will there be a list of general group classifications for given food types similar to the microbiological organisms that were published by the FDA for the Preventive Controls rules?”

Clay Detlefsen: Food defense is a very different rule. Liquid foods that are stored and/or mixed in bulk are a particular concern. Agents of concern include: chemical (including radiological) and biological agents, not just microbiological organisms.

Stone: I doubt it. Food safety and food defense are two entirely different sciences.

Food Online: Lori is asking, “Where is the best place to find the final rule?”

Detlefsen and Stone: The FDA’s website. The link directly to the rule is:

Food Online: Debbie asked, “I’m in an FDA facility. Is FSMA Intentional Adulteration/Food Defense required for USDA facilities, as well?”

Stone: Not if all the products are under FSIS oversight. If you are a dual jurisdiction facility, FDA & USDA, you’ll need to comply. All FSMA rules apply only to FDA-regulated food facilities.

Food Online: Debbie would also like to know, “Is complying with the Intentional Adulteration Rule required for all facilities, even those with juice and seafood HACCP?”

Detlefsen: Unless there is a specific exemption that your facility qualifies for both domestic and foreign facilities that are required to register with the FDA (under the Bioterrorism Act) are subject to the rule.

Stone: Clay is correct. Unless you have an exemption, yes. Facilities operating under Juice & Seafood HACCP must comply.

Food Online: Frank wants to know, “Should a Food Defense Plan be a standalone plan or intermingled with a Food Safety Plan?”

Detlefsen: Separate plans would be best. Please take some time to see a plan created with the FDA’s Food Defense Plan Builder.

Stone: A Food Defense Plan should be a standalone plan. However, elements of your food safety plan may be useful as part of your Food Defense Plan. For example, inspecting a clean tank before adding any new product, a common GMP, could be considered a mitigation strategy under certain circumstances.

Food Online: Lori is asking, “Is there a recommended tool/template for developing a Food Defense Program that will meet both FSMA and ISO22000 v4 requirements?”

Detlefsen: The FDA will require compliance with its rule, whether ISO22000 v4 help is yet to be determined.

Food Online: Gene is asking, “Do you think there will be specific regulations regarding trailer security seals?”

Stone: No, sealing of shipping trailers is not covered in the Intentional Adulteration Rule.

Food Online: Sharon has two questions. First,For FSMA's Food Fraud Rule, what additional controls will be required at FSMA's meat processing U.S. establishments?” She also wants to know, “For FSMA's Food Fraud Rule, what additional controls will be required from Canadian meat processing establishments?”

Stone: Considering the impact of food safety hazards introduced for “economic gain” is a requirement of the hazard analysis in the Preventive Controls rules, both for humans and animals. But, this is limited to items of a food safety nature that have had a pattern in the past. Secondly, it sounds like the foods in question are meat items, which in the U.S. are regulated by USDA, and therefore not covered by the Intentional Adulteration Rule.

Food Online: Alfonso is asking, “What are the key points to be in compliance with FDA to export product milk to U.S.?”

Detlefsen: Foreign facilities must contract with a third-party certifier and be in compliance with the Grade “A” Pasteurized Milk Ordinance. See:

Food Online: Bonnie and Tasha are asking, “What should we be looking for or requiring from our suppliers to confirm they meet the Food Defense Rule?”

Stone: You could ask to see their Food Defense Plan (FDP). The FDP will not only contain a vulnerability assessment meeting the four elements described above, but appropriate mitigation strategies to address significant vulnerabilities, monitoring, and verification activities.

The FDP will also include records of these activities and of corrective actions should a deviation from food defense norms occur. The supplier must have records documenting all of this, so records are another thing you could ask for. After September 2019, you could ask for the results of their last food defense inspection.

Food Online: Kelly is interested in knowing how these rules apply to packaging suppliers: What, if any, differences are applicable to them?

Detlefsen: They do not apply to packaging suppliers. That is not to say that packaging itself could not be a vector for an IA event, thought that would be extremely unlikely.

Stone: The rule applies to “all domestic and foreign facilities that are required to register with the FDA…”  Food packaging companies are not required to register with the FDA under the Bioterrorism rule. As a result, food packaging is not covered by the rule.

Food Online: Robyn would like to gain an understanding of how the new rule differs from previous Food Defense requirements that have been in place for several years.

Detlefsen: In the past, any efforts in support of food defense were voluntary and at the discretion of a facility. Many good programs were created, including, but not limited to, SQF’s food defense requirements. This rule is novel in that the FDA now has the authority and ability to require food defense compliance. Once the compliance date is reached, you need to be in compliance with the FDA’s rule.

Stone: All food defense measures previously put forward by regulatory bodies and third-party auditing schemes have been voluntary. Mitigation Strategies to Protect Food from Intentional Adulteration, as the rule is formally known, is a codified requirement. After September 2019, FDA-regulated firms in the U.S., and those wishing to export food to the U.S., must comply with the rule, unless they qualify for an exemption or delayed compliance date. By September 2021, FDA-regulated firms must comply, unless they qualify for an exemption under 21 CFR 121.5.

Food Online: Allen says, “I manage a chicken rendering facility which makes ingredients which go into pet foods. Am I correct in thinking the rules for Animal Food Defense are basically the same as for Human Food?”

Stone: Animal food operations are exempt from the Intentional Adulteration Rule.

Food Online: Michael is asking, “Is there any need to imbed inspection information in date code of individual products, cases, or pallets of products?”

Detlefsen: The FDA does not intend to get overly prescriptive with food defense practices and mitigation strategies; I would not anticipate any movement in this area by the FDA.

Stone: Not in the Intentional Adulteration Rule. The Bioterrorism Act of 2002 requires you to be able to trace goods one step forward and one step back so your date coding protocols could have some role in complying with that rule.

Food Online: Finally, Alphajour Ahmed has two questions. “What does a facility and corporate quality division do to ensure its Food Defense is solid and how is that verified?” He would also like to know, “How can the Food Defense Plan incorporate intentional and unintentional adulteration into its schemes?”

Stone: To assess regulatory compliance with the Intentional Adulteration Rule, you should conduct a line-by-line review to see where you may have shortcomings and develop a plan to eliminate those. Food defense deals only with intentional adulteration. Your food safety plan addresses unintentional adulteration. Thus, your FDP should not attempt to address unintentional adulteration.

Detlefsen: I concur with Warren’s response.