To: NMA General Members

Fr: Ken Mastracchio

Director of Regulatory Issues

Re: FSIS Micro Testing on RTE August 6, 1998

FSIS issued today Directive 10, 240.2, entitled "Microbial Sampling of Ready-To-Eat Products Produced By Establishments Operating Under A HACCP System." As the title indicates, the Directive applies only to RTE products produced in a facility operating under HACCP.

Significant features of the Directive are that the sampled lot "consists of all product produced under a single HACCP plan between performance of complete cleaning and sanitation procedures (clean-up to clean-up)." The Directive further states that, "In situations where recall, retention, or seizure is necessary, FSIS may determine that more product or less product than that produced from clean-up to clean-up under the HACCP plan is represented by the sample."

In the case of a positive result, the District Office will instruct the inspector to issue an NR and, if product has not been shipped, the establishment will be given the option to recondition or condemn the product. Additionally the inspector will perform a 02 procedure on the productís entire HACCP plan and procedures 01B01 and 01C01 on the establishments SSOP records for the time period of the sample selection.

If the inspector determines, based on this record review and other information, that the establishment is continuing to ship product that may be injurious to health "he or she should withhold the marks of inspection and inform the District Office."

Lastly the District Office will determine if enforcement actions are required and what if any those actions will be. According to the Directive, conclusions will be based on findings. For example a Salmonella finding may indicate a failure of a Critical Limit, where as a positive finding for Listeria may indicate a sanitation problem.

Of particular concern are the facts that the Directive greatly increases the size of the "sampled lot," whether or not the inspector in charge is qualified to determine that the establishment is continuing to ship product that may be injurious to health, and that the District Offices enforcement determination will mark a departure from applying a uniform National policy.

Copies of the directive will be made available at Please direct your questions and comments to our staff at (510) 763-1533.

OF SPECIAL NOTE: Instructions for sampling products produced by establishments NOT yet subject to the HACCP rule are found in FSIS Directive 10,240.1, Revision 1, Amendment 1, dated 6/2/97.