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Tip of the Week: What preventive controls requirements apply to human food waste streams?
Tip of the Week: What preventive controls requirements apply to human food waste streams?

Several clients have turned to AIB International for guidance on holding of human by-products for animal food or feed. We submitted the following question on FDA’s TAN network for regulatory input.

Are waste streams from human food manufacturing that ultimately go to animal food/feed required to meet all or some of the Preventive Controls for Animal Food Requirements? Specifically, what precautions, if any, are required for a flour mill regarding middlings? Is there anything specifically required if it comes off the floor?

Below is a summary of FDA’s response:

  1. If a registered FDA facility is in compliance with 21 CFR 117 and other applicable food safety requirements and is not further processing the human by-product then they would only need to implement the limited holding and distribution CGMP requirements found in 21 CFR 117.95 or 21 CFR 507.28 (they are identical requirements) to prevent contamination when holding and distributing by-products.
  2. Unprocessed middlings may fall into this category if the facility is already meeting human food safety requirements for operating their facility and for manufacturing/processing their human food up until the point where the by-product is generated.
  3. This regulation applies to human food facilities that both donate or sell a by-product for use as animal food. Labeling that identifies the by-product by the common or usual name must be affixed to or accompany human food by-products for use as animal food when distributed.
  4. If a facility conducts further processing of the human by-product for use as animal food/feed then they would need to comply with the applicable parts of 21 CFR 507 subpart B and sections of subpart A and F. The facility can choose to follow the CGMPs in the human food or animal food regulation.
  5. 21 CFR 507 or 21 CFR 117 does not specifically address whether human food by-products for use as animal food can come into contact with non-food contact surfaces, such as the floor. Under the Preventive Controls for Animal Food rule or Preventive Controls for Human Food rule you will need to consider whether the practices you use with respect to human by-products would result in an adulterated or contaminated animal food. For example, whether or not floor sweepings would be appropriate to include in animal food may depend on factors such as the condition of the floor, the potential for contaminants to be included in floor sweepings (e.g., gloves, trash, and cleaning chemicals and pesticides used in the facility), and the intended animal species. A facility may want to include this in the hazard analysis to determine whether there are any hazards associated with the human by-product/animal food that would require a preventive control.


Note from FDA: We are exercising enforcement discretion with regard to the preventive controls requirements for certain manufacturing/processing activities performed by human food manufacturers on their human food by-products for use as animal food. Your facility may fall under the FDA enforcement discretion policy if you conduct certain manufacturing activities to reduce weight, bulk, or volume or conduct certain activities to combine by-products or separate components and these activities are not intended to control hazards. For more information see Section III.D (pages 19-20) of Guidance for Industry Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs.

Additionally, FDA has made available Draft Guidance for Industry #239: Human Food By-Products for Use as Animal Food. When finalized, this draft guidance will explain FDA’s current thinking on facilities that produce both human and animal food, including human food by-products for use as animal food.

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