On February 8, 2013, the United States Department of Agriculture’s Food Safety and Inspection Service’s (FSIS) policy on “Test and Hold” will go into effect. This policy requires “official establishments and importers of record to maintain control of product tested for adulterants by FSIS and not allow such products to enter commerce until negative results are received.” The Federal Register publication outlining FSIS’ final policy may be viewed here.
In the past, while FSIS had encouraged establishments to hold product pending receipt of FSIS test results for adulterants, it had not required companies to hold product under their control until FSIS negative results were received. Many establishments did not follow this guidance and subsequently had to initiate recalls of product shipped in commerce due to positive results. FSIS adopted its new policy to prevent future recalls due to a company’s unwillingness or inability to hold product pending test results.
It is important to note, however, that FSIS’ new policy only applies to FSIS testing for adulterants and not to establishment testing for adulterants. However, FSIS continues to advise all establishments to hold product pending their own testing for adulterants.
The FSIS has identified the following adulterants as covered by the policy: (1) Salmonella, Listeria monocytogenes, E. coli O157:H7 and Non-O157:H7 STEC on ready-to-eat products, (2) E. coli O157:H7 and the six (6) Non-O157 STEC on raw non-intact beef products or products intended for such use, (3) Listeria monocytogenes on food contact surfaces or ready-to-eat products, (4) residues of veterinary drugs or carbadox in livestock and (5) economic adulterants. If FSIS tests product for one of these adulterants, FSIS would expect the establishment to have documentation and support that the product is controlled pending the results.
However, this does not mean the establishment cannot move the product to another location pending the test results. The establishment would have to show the product is still within its control as a result of measures such as company seals or “other adequate controls.” The establishment would also have to demonstrate that it has not yet completed its pre-shipment review of the product represented by the test results, as FSIS will deem this to mean that the product is in commerce and no longer held.
If product is shipped pending FSIS adulterant testing without adequate controls, FSIS would take the position that the establishment shipped uninspected and possibly adulterated product and would likely take enforcement actions, including suspension of inspection or issuance of a Notice of Intended Enforcement – besides requesting a recall of the affected product. So, come February 8th, it is important that establishments have written procedures and documentation in place to ensure that any product sampled by FSIS for an adulterant is held and that the pre-shipment reviews for these products are not completed until negative FSIS results are obtained.