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

By Sam Lewis

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, Stone addresses some of the unanswered questions 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?”

Stone: Assuming you are in a recall and have appropriately notified the FDA District Office, a disposition such as this would have to be approved by the D.O. and carried out under their oversight.

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?”

Stone: As of the last Q&A issued on the RFR in 2010, having the product at a third-party warehouse is NOT considered by the FDA to be under your control. Yes, you would have to report such an event through the RFR. See question E5 at http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm212793.htm#repo.

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?”

Stone: GMA would have to know considerable more detail to issue a recommendation.

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

Stone: I am not aware of any. Remember “animal food” encompasses hundreds, maybe even thousands, of species. The criteria that make a choking hazard for a hamster is probably not one for a horse.

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?”

Stone: There is no regulatory timeframe that I’m aware of. However, I’m sure the FDA would expect that the firm act with appropriate alacrity and not take a complacent attitude.

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?”

Stone: All product dispositions must be approved by the FDA District Office. The FDA may want to witness the destruction.

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?”

Stone: I find 21 CFR Part 7.4 to be more specific than the PCHF rule Part 117.139. If you follow the requirements of Part 7, you’ll be in compliance with PCHF as well.

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?”

Stone: The devil is in the details. This would have to be handled on a case-by-case basis. There is no regulatory magic number or percentage that automatically triggers a recall. Remember, not all recalls are Class One recalls; there are less-severe cases all the time.

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

Stone: It depends on the recall and the size of the firm. But, if a firm does not have adequate resources to implement and recover from the recall, the financial cost and the damage to their reputation could put them out of business for good.

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?”

Stone: I am not aware of a two-tier approach to a recall. GMA has discussed with the FDA the concept of a two-tiered inspection approach under PCHF. If you are a GMA member let me know and I can refer you to greater detail.

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

Stone: No, neither does.

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?”

Stone: While this is not a recall question, yes compliance with FSMA’s Foreign Supplier Verification Program is the responsibility of the importer as defined by that rule.

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?”

Stone: One of the major tasks necessary in a recall is to notify first-level consignees ASAP. If for some reason these consignees would be significantly different from one product to the next, this could be one reason. One recall plan can cover a multitude of products provided it’s in compliance with 117.139 and Part 7.

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?”

Stone: The manufacturing facility needs to have a recall plan as part of their Food Safety Plan. In a co-packing relationship, I’d expect this would include notification of the brand owner, though this is not part of the regulation. As brand owner, you’d want to know about a recall ASAP and not hear about it on the 11 o’clock news.

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?”

Stone: This would be evaluated on a case-by-case basis. I would advise you consult legal counsel to avoid slander/defamation and other issues.

In part two of this series, Vickery Brewer, consumer safety officer at FDA/CFSAN, will offer her perspective on the unanswered questions from Food For Thought: What Are FSMA's Recall Requirements? Stay tuned.