Food recalls significantly increased in 2025, with surges in both FDA and USDA regulated foods, and some major recalls are already occurring in 2026. If your product was implicated in an outbreak, how closely would you be able to define and separate your lots to limit the amount of product needing to be recalled? Regulatory agencies are very focused on the need for you to prove when the problem started and when it ended. Or if you cannot make that determination, when did you last have a clean break to sperate “good” product from “bad” product?
FDA Guidance on Sanitation Breaks
The FDA does not specifically mandate the use of sanitation breaks/clean breaks, recommending, or simply mentioning, them only in certain guidance. However, the lack of such breaks has been cited in 483s and warning letters. Sanitation breaks are not only essential for the safety of the food being produced, they are critical for defining lots in the event of a recall and putting brackets around potentially implicated product.
As discussed in the draft guidance for:
- The Preventive Controls Rule, FDA defines sanitation break as “stopping production to clean and sanitize all food-contact surfaces (FCSs) in the production system.”
- Sanitation programs for low-moisture RTE foods, FDA recommends that facilities “establish and implement routine ‘sanitation breaks’ in which you stop production to clean and sanitize all FCSs in the production system.”
- The Produce Safety Rule, FDA recommends that any alternative training include the purpose of clean breaks and the relationship between a clean break and lot establishment “in order to be considered equivalent to the standardized curriculum.”
- Additionally (while not a guidance), FDA’s Letter to Infant Formula businesses makes it clear that the detection of Cronobacter in a product in a facility implicates “all product produced before the contaminated lot going back to the last sanitation break” unless other conclusive identification of the origin of the contamination is made – as FDA also cites in a warning letter.
Warning Letter Cites Release of Adulterated Product
While that warning letter is for an infant formula manufacturer, it is wise for all food manufacturers to take its words to heart: “Following FDA’s review of your records and evaluation of the lack of intervening sanitation breaks, FDA determined that your firm released adulterated [product] into U.S. commerce.”
As defined in the letter, all product prepared, packed, or held under the same insanitary conditions as a positive batch is considered to be adulterated. This includes all product produced before the contaminated lot going back to the last sanitation break and after the contaminated lot until the next sanitation break. FDA further explains its recommendations for sanitation breaks in the low-moisture RTE guidance, advising that for non-continuous production systems, a sanitation break be established and implemented at the end of the daily production; for continuous production systems, the break should be at intervals frequent enough to help limit the amount of food that could be affected by a contamination event. In either case, equipment should be periodically disassembled to expose, clean, and sanitize surface areas that are not readily accessible during routine sanitary operations.
Clean Break Documentation is Essential
So, if there is no documented clean break with validated sanitation processes, a recall due to adulteration – be it microbiological, allergenic, chemical, or physical – can impact a significantly greater amount of product than may actually be potentially contaminated. It could even lead to a “rolling recall,” with the company having to publish numerous recall notifications as further lots are added to the recall.
It also is important to understand that simply recording that you conducted a clean break, without further detailing the sanitation procedures taken, will not necessarily be enough to satisfy FDA or limit a recall. Your documentation needs to include exactly what cleaning and sanitation was conducted along with the results of swabbing performed after the sanitation process to validate its efficacy.
In Summary: Sanitation, or clean, breaks are essential to ensure that your facility and equipment are regularly and thoroughly cleaned and sanitized. But they also benefit your business by defining lots and helping to limit the extent of product implicated in a recall.
