Unfinished Business: Answering Your Questions About FSMA's Recall Requirements (Part Two Of Two)

By Sam Lewis

If you haven’t already, be sure to read PART ONE of this series

On September 12, Food Online hosted a live web chat, Food For Thought: What Are FSMA's Recall Requirements? featuring Vickery Brewer, consumer safety officer at FDA/CFSAN, and Warren Stone, senior director of science policy at the Grocery Manufacturers Association (GMA). In this 45-minute live Q&A, Stone and Brewer answered the audience’s questions about FSMA’s recall requirements. While the session was educational and informative, there wasn’t enough time to answer every question. Here, Brewer addresses some of the unanswered question from the live web chat.

Food Online: Omar asked, “If a product is known to be contaminated with Listeria monocytogenes, is it ok to sell within state to someone who will conduct a kill-step to the product?”

Brewer:  In any situation involving pathogen contamination, the FDA would expect firms to take immediate steps to investigate the likely source of the contamination, determine the scope of the problem to minimize public exposure if food has been shipped, and to prevent future contamination of food. Regarding the sale of contaminated food within a state, the FDA will generally defer to its state regulatory partners in situations of solely intrastate operation and sales. Often the FDA assists the states in determining on a case-by-case basis, whether it is appropriate to allow reconditioning or reprocessing of a contaminated food, or if it may be more appropriate to destroy or divert the food.

Food Online: Another question from Omar: If a determination is made of an issue with our product and that product is in a third-party warehouse, but that product cannot ship without our approval, do we need to report to RFR?”

Brewer: If the violating product has left the control of the firm, such as to a third-party warehouse, then the product should be recalled and an RFR needs to be reported. Whether you report to the RFR also depends on whether the product is an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

Food Online: Deena asked, “Would a single report of a consumer complaint of foreign object choking hazard require a report to RFR if you determine that it is an isolated incident?”

Brewer: We would need to know the details of each specific case. Foreign object issues are looked at on a case-by-case basis. If unsure whether to report to the RFR, contact your local FDA District Office Recall Coordinator. Further, it is a business decision, as to whether you are comfortable that it is an isolated instance.

Food Online: Laurie asked, “Is there size guidance for foreign objects for human food sent to animal/pet food?”

Brewer: Human food and human food by-product associated with a food safety concern (e.g. foreign objects) should be evaluated by the firm’s management to determine whether it is appropriate to divert to animal food. This should consider: 1) whether any human food safety concern is an animal food safety concern; 2) the type of animal food the food will be used for, or the animal species to which it will be fed; 3) the level of the food safety concern, considering the animal species to which it will be fed; and 4) the FDA's guidance on the diversion of contaminated or adulterated food for use as animal food. The management should use this and any other relevant information to make a determination whether the food is safe to use as an animal food prior to marketing or distributing the food for use as animal food.

Food Online: Steven asked, “Once a recall has been issued and the customers have been contacted, is there a timeframe for the traceability exercise? In other words, is there a timeframe when the customers must report back to the manufacturer how much affected product they have, whether it made it into the product?”

Brewer: There is no explicit timeline. The FDA District Recall Coordinator will expect periodic (often weekly) reports back from the recalling firm on the status of the disposition of the recalled product until it is all accounted for.

Food Online: Karen asked, “Is it allowable to tell the customer to destroy recalled products? What are the proper steps for destroying/returning products subject to a recall?”

Brewer: This would depend on the circumstances. Disposition of suspect product is part of the conversation a firm would have with the FDA District Office Recall Coordinator. For high-profile cases or serious health hazards, such as may be associated with an outbreak, the FDA may request to witness the destruction/disposition of the product of the recalling firm.

Food Online: Pauline asked, “What is specifically required in the four elements of the recall plan? What are the specifics that need to be included to meet the requirements of the recall plan?”

Brewer: The Preventive Controls for Human Food (PCHF) Rule outlines the required  elements in Section 117.139(b). However, the specific content in a recall plan may vary from firm to firm. Note that the requirements for conducting a recall are outlined in 21 CFR Part 7. The FDA does not recommend or ‘approve’ recall plans.

Food Online: Peter asked, “Where can people find guidance regarding how many complaints of different issue types might merit a recall? Are there any standards, or is it purely a judgement call?”

Brewer: A recall should be initiated when a firm is aware of a violation. When a firm investigates consumer complaints and becomes aware that its product is violative, a recall should be initiated regardless of whether there are complaints.

Food Online: Carolina asked, “In your opinion, to what extent can a product recall constitute a crisis for a company in the food industry?”

Brewer: That depends on the circumstances. For a small firm with a few products, the effects will be more pronounced than for other scenarios. It is important to have an action plan ready to implement and to have to have preventive controls in place to reduce the likelihood of processing violative product, and situations that warrant   a recall.

Food Online: Archana asked, “What is a two tier approach to recall plans and inspections and will the FDA expect food makers to adopt it?”

Brewer: The two-tier approach is a concept that would modify the current FDA inspection approach for firms that have overarching food safety programs (e.g. Recall Plans, supply-chain programs, etc.) that are developed and managed at the business or corporate level. The first tier involves FDA assessment of corporate programs in consult with appropriate firm officials including corporate management and experts; and the second tier involves FDA assessment of a firm’s implementation of those programs at a food facility. There are numerous potential benefits to using this type of approach (e.g., improved efficiency and consistency of FDA inspections, more targeted and potentially reduced inspection time, improved public health benefit by identifying overarching issues that may impact numerous firms). However, there are also some challenges that FDA is currently working through in order to implement this different approach in the future (e.g., IT-related issues of how and where to identify a firm’s participation in this voluntary program and how to communicate results from the tier 1 assessment to better inform the tier 2 inspection, how to ensure protection of information provided during tier 1 review, how often to conduct tier 1 assessments).

Food Online: Craig asked, “Does either Part 7 or Part 117 require verification or validation of the recall plan?”

Brewer:  No, 21 CFR Part 7.4 outlines the requirements of recall. PCHF Rule 117.139 requires the establishment of a recall plan describing the steps and procedures and assignment of responsibilities for carrying out the recall plan. Inspections will focus on the adequacy of the written elements of the plan, rather than implementation of the plan.

Food Online: Robert asked, “Regarding Foreign Suppliers under FSMA, isn't the onus on the importer to verify that the supplier is FSMA/FDA compliant? Why or why not?”

Brewer: Yes, the U.S. importer is required to ensure that the imported product meets the requirements of the new FSMA rules.

Food Online: Amber asked, “It was mentioned in the web chat that different recall plans could be written for different products, if they vary in type enough. Are there examples of this or can you go into further detail? Maybe a liquid bulk product vs. a packaged product?”

Brewer: The Recall Plan should be written as appropriate to the firm’s operation(s). The decision to write one or more Recall Plans may depend on the types of products, who the responsible persons are, the manufacturing locations, etc.

Food Online: Becky asked, “A lot of my clients are “brands,” where they use co-packers to produce the product. They are not the manufacturer, but they purchase and sell the goods. The rumor out there is that these "brands" need recall plans as well. Is this true? Why?”

Brewer: The Manufacturer, as the firm covered under PCHF Rules, is required to have a Recall Plan. Under 117.139 (b) (1). The manufacturer has to inform its consignees – the “brands” who purchase the products. The Brand firms would fall under 21 CFR, Part 7 requirements for conducting a recall of the products.

Food Online: Elaine asked, “What is the best way to notify the public/consumers about a recall of a raw ingredient used in our products to avoid damaging our brand/name/reputation?”

Brewer: This would depend on the situation and your relationship with your supplier. You may issue your own public statement/press release explaining that the cause is an ingredient from a supplier, without having to name that supplier. Whether you name your supplier would be up to your relationship with that supplier.