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Appendix A

Guidelines for Developing a Standard Operating Procedure for Sanitation (Sanitation SOPs) in Federally Inspected Meat and Poultry Establishments

I. Introduction

Foodborne illness is a significant public health problem in the United States. While data on illness associated with meat and poultry products are limited, data from various sources suggest that foodborne microbial pathogens may cause up to 7 million cases of illness each year and 7,000 deaths. Of these, nearly 5 million cases of illness and more than 4,000 deaths may be associated with meat and poultry products.

The Food Safety and Inspection Service (FSIS) is pursuing a broad and long term science-based strategy to improve the safety of meat and poultry products to better protect public health. FSIS is undertaking steps to improve the safety of meat and poultry throughout the food production processing, distribution and marketing chain. The Agency's goal is to reduce the risk to public health of consuming meat and poultry products by reducing pathogenic microbial contamination. The FSIS strategy relies heavily on building the principle of prevention into production processes.

Sections 308.7, 381.57 and 381.58 of the Meat and Poultry Inspection Regulations require that rooms, compartments, equipment and utensils used for processing or handling meat or poultry in a federally inspected establishment must be kept clean and in a sanitary condition. Establishments are responsible for sanitation of facilities, equipment and utensils.

Sanitation maintains or restores a state of cleanliness, and promotes hygiene for the prevention of foodborne illness. Sanitation encompasses many areas and functions of an establishment, even when not in production. However, there are certain sanitary procedures that must be addressed and maintained on a daily basis to prevent direct product contamination or adulteration. Good sanitation is essential in these areas to maintain a safe food production process.

FSIS is requiring meat. and poultry establishments to develop and implement a written Standard Operating Procedure for sanitation (Sanitation SOPs) which addresses these areas. An establishment's adherence to its written SOP for sanitation will demonstrate knowledge of and commitment to sanitation and production of safe meat and poultry products.

New part 416 to the Meat and Poultry Inspection Regulations requires that a written Sanitation SOP contain established procedures to be followed routinely to maintain a sanitary environment for producing safe and unadulterated food products. Plant management must develop a Sanitation SOP that describes daily sanitation procedures to be performed by the establishment. A designated establishment employee(s) must monitor the Sanitation SOP and document adherence to the SOP and any corrective actions taken to prevent direct product contamination or adulteration. This written documentation must be available to HIS program employees.

These HIS guidelines should help federally inspected meat or poultry establishments develop, implement and monitor written Sanitation SOPs.

The Sanitation SOP developed by the establishment must detail daily sanitation procedures it will use before (pre-operational sanitation) and during (operational sanitation) operation to prevent direct product contamination or adulteration. FSIS program employees will verify an establishment's adherence to its Sanitation SOP and will take appropriate action when there is noncompliance.

These guidelines, where applicable, are for:

  • livestock slaughter and/or processing establishments;
  • poultry slaughter and/or processing establishments;
  • import inspection establishments; and
  • identification warehouses.

    • The establishment should update the Sanitation SOP to reflect changes in equipment and facilities, processes, new technology or designated establishment employees.

    II. Pre-Operational Sanitation

    Established procedures of pre-operational sanitation must result in clean facilities, equipment and utensils prior to starting production. Clean facilities, equipment and utensils are free of any soil, tissue debris, chemical or other injurious substance that could contaminate a meat or poultry food product. Pre-operational sanitation established procedures shall describe the daily, routine sanitary procedures to prevent direct product contamination or adulteration. The sanitary procedures must include the cleaning of product contact surfaces of facilities, equipment and utensils to prevent direct product contamination or adulteration.

    The following additional sanitary procedures for preoperational sanitation might include:

  • Descriptions of equipment disassembly, reassembly after cleaning, use of acceptable chemicals according to label direction and cleaning techniques.
  • The application of sanitizers to product contact surfaces, after cleaning. Sanitizers are used to reduce or destroy bacteria that may have survived the cleaning process.

    III. Operational Sanitation

    All federally inspected establishments must describe daily, routine sanitary procedures that the establishment will conduct during operations to prevent direct product contamination or adulteration. Established procedures for operational sanitation must result in a sanitary environment for preparing, storing or handling any meat or poultry food product in accordance with sections 308/381 of the Meat and Poultry Inspection

    • Regulations. Established procedures during operations might include, where applicable:
    • equipment and utensil cleaning-sanitizing-disinfecting during production, as appropriate, at breaks, between shifts and at midshift cleanup;
  • employee hygiene: includes personal hygiene, cleanliness of outer garments and gloves, hair restraints, hand washing, health, etc.; and
  • product handling in raw and in cooked product areas.

    The established sanitary procedures for operational sanitation will vary with the establishment. Establishments with complex processing need additional sanitary procedures to ensure a sanitary environment and to prevent cross contamination. Establishments that do not slaughter or process (such as an Import Inspection facility) should develop established sanitary procedures specific to that facility.

    IV. Implementing and Monitoring of the Sanitation SOP

    The Sanitation SOP shall identify establishment employee(s) (positions rather than specific names of employees) responsible for the implementation and maintenance of the Sanitation SOP. Employee(s) are to be identified to monitor and evaluate the effectiveness of the Sanitation SOP and make corrections when needed.

    The evaluation can be performed by using one or more of the following methods:
    1. organoleptic (sensory-e.g., sight, feel, smell);
    2. chemical (e.g., checking the chlorine level); and
    3. microbiological (e.g., microbial swabbing and culturing of product contact surfaces of equipment or utensils).

    Establishments might specify the method, frequency and recordkeeping processes associated with monitoring. Pre-operational sanitation monitoring should, at a minimum, evaluate and document the effective cleaning of all direct product contact facilities, equipment and/or utensils that are to be used at the start of the production. Operational sanitation monitoring should, at a minimum, document adherence to the SOP, including actions that identify and correct instances or circumstances of direct product contamination which occur from environmental sources (facilities, equipment, pests, etc.) or employee practices (personal hygiene, product handling, etc.) All establishment records of pre-operational and operational sanitation monitoring, including corrective actions to prevent direct product contamination or adulteration, must be maintained by the establishment for at least six months, and be made available to FSIS program employees. After 48 hours, they may be maintained off-site.

    V. Corrective Actions

    When deviations occur from the established sanitary procedures within the Sanitation SOP, the establishment must take corrective actions to prevent direct product contamination or adulteration. Instructions should be provided to employees and management officials for documenting corrective actions. The actions must be recorded.


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