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United States Department of Agriculture
Washington, D.C. 20250-3700

Key Facts: HACCP Implementation

January 1997
Slightly Revised May 1998

SSOP's and Generic E. coli Testing

Implementation of the Food Safety and Inspection Service's final rule on Pathogen Reduction and Hazard Analysis and Critical Control Points (HACCP) began on January 27, 1997. On that date, all plants that slaughter and process meat and poultry were required to have in place standard operating procedures (SOPs) for sanitation to ensure they are meeting their responsibility to keep their facilities and equipment clean. In addition, slaughter plants were required to begin testing their products for generic E.coli to verify that their process control systems are working as intended to prevent fecal contamination, the primary avenue of contamination for harmful bacteria. (Very low-volume plants do not have to begin testing until June 1997.) The remaining two provisions of the final rule, establishing the system of process controls to prevent food safety hazards known as HACCP, and meeting performance standards for Salmonella, will be phased in according to plant size beginning on January 26, 1998.

These regulatory measures are but one link in a comprehensive food safety strategy that addresses health hazards in the farm-to-table chain.

Sanitation Standards Operating Procedures

Good sanitation is a fundamental requirement of Federal meat and poultry inspection laws and is essential to preventing harmful contamination of meat and poultry products. Poor sanitation practices, such as improperly cleaned facilities and equipment, are the most frequent deficiencies found in some meat and poultry plants. There is a direct and substantial link between insanitary practices in meat and poultry plants and the likelihood of product contamination with pathogenic bacteria.

In the past, some federally-inspected meat and poultry plants have relied on inspectors to identify deficiencies on a daily basis. But as of January 27, 1997, all federally-inspected meat and poultry plants must have in place written sanitation SOP's to demonstrate that they are meeting all basic sanitation requirements every day. The new rule does not impose new sanitation requirements; rather, it institutes a process to insure better compliance with the existing Federal sanitation requirements.

FSIS inspectors have received training on this new procedure as well as culture training to enable them to do their jobs more effectively. Starting on January 27, 1997, plants must comply with the following five requirements:

  1. Each establishment must have a written plan describing daily procedures the plant will conduct before and during operations and the frequency at which they will be conducted to prevent direct contamination or adulteration of products. Specificity and detail on how to accomplish this is left up to the establishment, although the emphasis of the requirement is on the prevention of direct contamination or adulteration of product.
  2. The Sanitation SOP is to be signed by a company official with overall on-site authority or a higher-level official of the plant. It must be signed upon initiation and when any subsequent modifications are made to the plan. Plants have flexibility to determine who this official is as long as he or she has on-site authority.
  3. The Sanitation SOP must identify pre-operational sanitation procedures and distinguish them from sanitation activities to be carried out during operations. These pre-operational procedures, at a minimum, must address the cleaning of food contact surfaces of facilities, equipment and utensils. Effectiveness of pre-operational sanitation procedures will be determined through the verification, not the evaluation, process.
  4. The plant must identify the individuals who are responsible for implementing and maintaining daily sanitation activities. The plant does not need to identify the employees who actually perform the sanitation procedures.
  5. The establishment must maintain daily records that demonstrate it is carrying out the sanitation procedures outlined in its Sanitation SOP plan, including the corrective actions taken. There is no set format required, and such records may be maintained on a computer disk or on paper, as long as they are accessible to inspection personnel.

Testing for Generic E. coli

Another one of the four essential elements of the new food safety system involves microbiological testing by slaughter plants for generic E.coli on carcasses to verify that the process is under control as far as prevention and removal of fecal contamination is concerned. Fecal contamination is one of the principal sources of pathogenic organisms that contaminate carcasses. Generic E.coli is commonly found in the intestinal tract of food animals.

The presence of microorganisms on raw meat and poultry is almost unavoidable and quite variable. Such testing helps establishments know how effective their slaughter and sanitary dressing procedures are at preventing and removing microbial contamination.

All slaughter plants, except for very low-volume plants, were required to begin testing for generic E.coli starting on January 27, 1997. Six months later, after plants have had the opportunity to gain experience in conducting E.coli testing, FSIS will start reviewing E.coli test results.

Generic E.coli was selected by FSIS as the target organism because of the scientific consensus that it is a useful indicator of process control, because such analysis is relatively easy and inexpensive to perform, and because levels of the organism can be measured.

Sampling frequency is being determined by the plant's production volume and includes a large number of tests each day at high-volume plants and decreases to testing once a week at the smallest plants. In cattle, such frequency is one sample per each 300 carcasses, in hogs one in 1,000, in turkeys one in 3,000, and in broilers one in 22,000. Before sampling starts, the establishment must prepare written procedures specifying when samples will be taken, who is responsible for sampling, how samples will be handled, and what test methodology will be used.

Cattle and hog samples are to be collected from chilled carcasses by sponging three sites on a carcass surface or by using the baseline excision method. Poultry samples are to be collected after the drip line using a whole bird rinse. Low volume companies will be testing every summer by pulling weekly samples that must be collected and tested until one series of 13 samples meets the E.coli performance criteria. Once completed, a low-volume plant will not need to test until the same time the following year, unless a change occurs that may affect existing control procedures. Slaughter plants operating under HACCP systems will continue to use E. coli testing to verify that their process is controlling fecal contamination, although they could use alternative frequencies.

Microbiological performance criteria, developed using data on the prevalence of E.coli from FSIS's national baseline surveys, will be available to help plants verify that their process controls prevent fecal contamination effectively. These criteria are not enforceable regulatory standards, but are rather intended to provide an objective point of reference that will help slaughter plants ensure that they are meeting their obligation to prevent and reduce fecal contamination.

Plants will record test results and make them available to FSIS inspectors. The performance criteria require review of a moving "window" series of test results to provide a continuous picture of the plant's performance. This minimizes the risk that the plant's process control will be questioned because of a chance test result but is still sensitive enough to detect when performance falls short.

Because FSIS inspectors have not yet received training on the E. coli testing requirement, FSIS has established a special evaluation team of compliance officers, circuit supervisors and other supervisory-related personnel to conduct evaluation and verification activities in the approximately 562 slaughter plants that began testing on January 27. Training of FSIS inspection personnel begins in September 1997; after training is completed, those activities will be performed by the in-plant inspectors.

FSIS will soon issue technical corrections and amendments to the final rule.

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