The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry entitled “Reconditioning of Fish and Fishery Products by Segregation.” This draft guidance provides information to owners of fish and fishery products regarding the reconditioning of adulterated products and provides recommendations on how to demonstrate that portions of the affected articles are safe for consumption. This guidance will help ensure that safe product reaches consumers.
Anyone introducing, delivering, or receiving fish and fishery products in interstate commerce is ultimately responsible for ensuring that the food is safe and complies with all applicable laws and regulations. This draft guidance provides industry with an explanation of two approaches to recondition adulterated fish and fishery products. Specifically, this draft guidance provides suggestions for:
- Segregation based on a production-related rationale supported by production records identifying the cause of the adulteration and its restriction to only a portion of the article along with sampling and testing to confirm that the segregation was successful.
- Segregation based on the results of statistically significant sampling and testing. Here, the sampling and testing forms the basis for the segregation.
Fish or fishery product owners may use an alternate approach for reconditioning if it satisfies the requirements of the applicable statutes and regulations.
The comment period will be open for 60 days starting Sept. 17, 2019.