FSIS DIRECTIVE

10,240.2

8-5-98

MICROBIAL SAMPLING OF READY-TO-EAT PRODUCTS PRODUCED BY ESTABLISHMENTS OPERATING UNDER A HACCP SYSTEM

I. PURPOSE

This directive provides inspection personnel with instructions sampling ready-to-eat meat and poultry products 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.

II. RESERVED

III. RESERVED

IV. REFERENCES

Part 417 of the Federal meat and poultry products inspection regulations.

FSIS Directive 10,210.1, dated 10/15/97

FSIS Directive 5000.1, dated 11/21/97

FSIS Directive 5400.5, dated 11/21/97

V. TERMINOLOGY

The following term will be used in this directive:

Sampled Lot - The sampled lot consists of all products produced under a single HACCP plan between performance of complete cleaning and sanitation procedures (clean-up to clean-up) . 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. FSIS will consider such factor as the establishment's coding of products ; the pathogen; the process; the establishment's testing under its HACCP plan; the establishment's HACCP plan monitoring and verification activities performed in accordance with 417.2 and 417.4; SSOP records as required in 416.16; and whether some or all of the processes' functioning under the same HACCP plan have been affected.

VI. POLICY

FSIS verifies the adequacy of an establishment's HACCP system by determining whether each HACCP plan meets the requirements of 9 CFR Part 417, and all other applicable regulations. Verification activities include, but are not limited to, collecting and testing ready-to-eat product for microbial hazards. Of samples test positive for a microbial hazard, action will be taken on product represented by the samples. Inspection personnel will determine whether the establishment is continuing to ship product that may be injurious to health and, if so, will withhold inspection. As provided in 9 CFR 417.6(e), the establishment's HACCP plan may be determined to by inadequate because adulterated product was produced or shipped. Note, the cause of a positive finding in ready-to-eat product varies from case to case, based on the pathogen or toxin found and the type of processing involved. For example, in many cases a positive result for Salmonella would indicate that critical limits in a HACCP plan were not met, while a positive for Listeria monocytogenes could indicate that there is a sanitation problem. This includes whether some or all other processes functioning under the same HACCP plan have been affected, what pathogens or toxins are involved, whether there have been any other incidents of contamination in the establishments associated with the pathogen or toxin, and whether there has been persistent and recurring noncompliance in the establishment.

VII. MICROBIOLOGICAL SAMPLING PROGRAM

A. When samples are scheduled to be taken at an establishment, inspection personnel receive FSIS Form 10,210-3 from the Office of Public Health and Science with information specific to the sample to be collected. Using the project number in Block 14 of the form, inspection personnel follow the corresponding instructions (found in FSIS Directive 10,210.1) for collecting and shipping samples.

B. Inspection personnel should notify establishment management at the time of sampling.

C. If possible, inspection personnel will only collect and mail the sample(s) from the establishment's current day's production that has passed the establishment's pre-shipment record review (see 417.5(c)). If not possible, such as in establishments where production is held off-site prior to completion of the pre-shipment record review or the pre-shipment review is performed at a later date, inspection personnel will collect samples of the current day's production, freeze them, keep them in a secure location, and postpone mailing the sample(s) until the pre-shipment record review is complete, and the product is eligible for shipment. If for some reason the establishment decides not to complete the pre-shipment review and, therefore, not to ship the product, inspection personnel should discard the samples and then take new samples from subsequent production following the procedures above.

VIII. TEST RESULTS

A. Test results will be distributed as described in FSIS Notice 8-98.

B. If the sample tests negative for microbial hazards, the establishment will remain in routine sampling under the Microbiological Sampling Program.

C. If the sample tests positive for microbial hazards, the DO provides the Inspector-in-Charge (IIC) with the information necessary to complete a Noncompliance Record (NR) (FSIS form 5400-4). The IIC documents the procedure as unscheduled on the Procedure Schedule and, in Block 8 on the NR, records ISP code 05B02. No trend indicators are checked. In Block 10 on the NR, the IIC includes:

a. the sample collection date,

b. the product name, and

c. the organism or toxin found.

D. The IIC provides a copy of the NR to the establishment and sends a copy to the DO.

IX. Program Personnel Responsibilities

A. The IIC, DO, and Emergency Response Division coordinate regarding the necessity of product retention, seizure, or recall. The DO will instruct inspection and enforcement personnel as necessary.

B. If product from the sampled lot is in the establishment, inspection personnel will verify that the establishment prevent product from entering commerce in accordance with 417.3(a)(4) or (b)(3), if necessary inspection personnel will retain that product. Inspection personnel will release the product if the establishment can treat it in a manner so that it is no longer adulterated, or condemn the product if the establishment fails to treat it in a manner so that it is no longer adulterated, (See FSIS Directive 5000.1 Part II III.B.3.a.(3) & b and Part III III.B.2.).

C. Inspection personnel will perform an 02 procedure on the products' HACCP plan and procedures 01 B01 and 01 C01 on the establishment's SSOP covering the time period from when the sample was collected to the present. (See FSIS Directive 5400.5).

D. If the IIC determines, based on the available information, that the establishment is continuing to produce and ship product that may be injurious to health, he or she should withhold the marks of inspection and inform the DO.

E. Inspection personnel will verify that the establishment performs the necessary corrective and preventive actions in accordance with 416.15 and 417.3 (See FSIS Directive 5000.1 Part II III.B.3 and Part III III.B.).

F. The DO will make a determination, based on consideration of the policy issues discussed in paragraph VI., regarding the necessity of enforcement action and instruct inspection and enforcement personnel as needed. (See FSIS Notice 12-98).

Direct questions regarding the directive through supervisory channels.