Questions have arisen concerning what is adequate reconditioning of food products found to be prepared, packed or held under conditions which cause them to be adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.
The following policy applies to foods which are proposed to be reconditioned after having been seized because of being prepared, packed, or held under Section 402(a)(4) conditions. It also applies to the situation where a lot of food is being voluntarily reconditioned after having been prepared, packed, or held under Section 402(a)(4) conditions.
*FDA will accept reconditioning proposals for foods adulterated due to Section 402(a)(4) conditions when such proposals include provisions for determining:
- whether the food has become physically contaminated,
- the extent and type of any contamination, and
- procedures that will result in eliminating such contamination.
In addition, the proposal must provide for removing the Section 402(a)(4) conditions which cause the product to be adulterated. These conditions pertain not only to the product itself, but also to the environment found within the facility in which the product was prepared, packed or held. This is particularly important because a Section 402(a)(4) charge is actually an environmental charge. Correction could be achieved, for example, by brushing or vacuum cleaning filth from the outside of a bag, stripping stained outer layers from a multi-ply bag, or rebagging the product. Such actions, however, are product specific and do not address the corresponding corrections necessary to remove the (a)(4) conditions in the facility. Examples of facility related corrections could include: contracting with an exterminator, performing structural modifications to the actual building to preclude rodent entry, setting up a plan to assure appropriate stock rotation or other actions that would result in the elimination of the rodent or insect infestation. If the facility deficiencies are not corrected, moving the food to a sanitary facility may be necessary before reconditioning can begin.
Sampling and testing may also be required during and after completion of the reconditioning process.*
*Material between asterisks is new or revised*
Revised: 10/1/80, 7/21/89
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.