Adulterated-product handling clarifications
FSIS revised directive on identifying, segregating and holding adulterated product.
On Feb. 12, the Food Safety and Inspection Service (FSIS) issued Directive 5000.3, Rev. 1, Identification and Segregation of Product. The directive instructs inspection program personnel (IPP) on how to verify that meat and poultry establishments identify, segregate and properly hold adulterated product that has been returned to the establishment or has been received by the establishment for further processing. It also provides instructions for verifying that an establishment properly holds products pending laboratory results for adulterants.
The instructions for verifying that adulterated products are properly identified, segregated and held when received by an establishment are unchanged from previous directives and are relatively straightforward. If adulterated product is returned to an establishment because of a recall or other reason, IPP are to verify that the establishment has controls in place to segregate and hold the product until proper disposition. If adulterated product is received by an establishment for further processing, IPP are to verify that the establishment has addressed the treatment of the product in its HACCP plan and that the adulterated product is identified and segregated from non-adulterated product pending proper disposition. FSIS will request a recall if adulterated product does not receive proper disposition and enters commerce.
Unfortunately, the revised instructions for verifying that establishments properly hold products pending laboratory results for adulterants are less clear and have caused confusion in the industry. Specifically, the directive addresses both industry and agency testing for adulterants and provides that the instructions now “reflect that FSIS will withhold its determination as to whether meat and poultry products are not adulterated, and thus eligible to enter commerce, until all results that bear on the [adulteration] determination have been received.”
This has caused concern that the agency now requires establishments to hold product pending industry test results, as well as pending agency test results. It has also caused concern regarding whether establishments may continue to ship product to third-party entities pending test results, provided that the establishment maintains “adequate control.”
Based on informal discussions with agency personnel, it is our understanding that the revised directive was not intended to change FSIS’ policy with respect to test and hold. Although the agency encourages the holding of product pending industry test results for adulterants, it is not required. FSIS only requires the holding of product pending agency test results for adulterants. This would include agency testing for: STEC in raw, non-intact beef and products intended for such use; Salmonella and Listeria monocytogenes in ready-to-eat products and on food contact surfaces; residues in livestock; and economic adulteration (e.g., added water in ground beef).
Furthermore, it is our understanding that current best practices for controlling product pending test results remain adequate. If either an agency or industry test result is positive for an adulterant, IPP are to verify that the establishment has maintained lot integrity, has ownership of the product and the product has not entered “commerce.” Product will not be deemed in “commerce” if the producing establishment has direct control of the product, as exhibited by any one of the following facts:
- The product is at the establishment;
- The product is located on the premises owned by the producing establishment;
- The product is at a sister establishment owned by the same establishment or corporation;
- The product is at a warehouse owned by the establishment or corporation;
- The product is on a truck or other conveyance owned or operated by the establishment or corporation; or
- The product is offsite under company control (company seals not required) or FSIS control.
With respect to the last bullet point, product would be considered under adequate company control provided that the establishment has measures in place to ensure the product is not distributed without the producing establishment’s authorization and that pre-shipment review is not completed until satisfactory results are received.
It should be emphasized that although FSIS does not require establishments to hold product pending industry test results for adulterants, it is highly recommended. If test results are positive for adulterants and the establishment loses control or ownership of the product, the product would be subject to a recall. If this occurs, FSIS will also assess whether additional regulatory actions or sanctions are appropriate.
FSIS has issued compliance guidelines to help establishment comply with the agency’s hold and test policy. We encourage establishments to review these guidelines to ensure their controls for holding product pending test results conform to agency policy and expectations. NP