BLOCK 8.FSIS Uses the Deficiency Classification Guide BLOCK 9.FSIS Takes Official Control Action Taken as arranted Process De PREAMBLE However, the final rule itself remains nonprescriptive in that it requires remember that the primary focus or emphasis is on deficiencies in elf what procedures are quipment, facilities, or employee practices which result in direct cessary to prevent insanitary conditions that will cause direct product product contamination or adulteration contamination of adulteration Overall, the comments confirmed that nile proper sanitation is a common need in every food production city, the means to achieve it are diverse and establishment-specific Establishments that now have good sanitation and effective process As FSIS ontrols are expected to continue using techniques that work in their of what is known establishment. Other establishments will need to analyze and select inspection and what is reasonable to assume based effective abatement procedures among various alternatives for attaining ations and available information a sanitary processing environment. What works in one establishment may or may not work in another. DECISIONS d rule also solicited comments as to whether FSis should After FSIS inspection personnel classify a deficiency using the DCG mandate Good Manufacturing Practices(GMP's) for all or certain they wil proceed to animation SOP's. FSIS listed illustrations in the proposal of elements hat might be mandatory elements of Sanitation SOP's. Although some BLOCk 9 to determine if official control action is warranted commenters expressed support for making GMP's or other practic andatory, many objected to such specific requirements on the basis hat they would be infeasible, FSIS agrees with stated that detailed GMP regulations are infeasible because of the difficulty in making them specific enough to be useful FSIS also was concerned that such specificity could result in lost flexibility FSIS Directive 11, 100.3, Evaluating. Verifying and Enforcing a prescribe a singe format for Sanitation Standard operating Procedure(Instructions to Inspectors Regarding Deficiencies and Enforcement Actions It will be the responsibility of each establishment to consider ex FSIS regulations and guidelines, evaluate its facilities, processes, and mplemented to prevent direct product contamination or aduteration, and describe these procedures in Sanitation SOPs Sanitation SOP's require the establishment to implement procedures signed to prevent direct product contamination or adulteration herefore, deficiencies classified as'criticar, in addition to requiring ficial action, will be consists of retention of products, and rejecting equipment, rooms ndor areas: thereby withholding inspection as required, to prevent the use of facilities and equipment in the production of products until a
blocK 9.FSIS Takes Official Control Action Taken a BLOCK 9.FSIS Takes Official Control Action Taken as lassified as"minors"will not require official control action. FSIS inspection personnel will determine wh Major Deficiencies official control action is necessary for deficiencies classified as"ma Minor deficiencies and major deficiencies do not constitute a Sanitation ajor deficiencies may require official control action. U sing the DCG SOP failure. However, minor and major deficiencies do require judgment, FSIS inspectors will decide if official control corrective and preventive actions. Documentation of minor and major eficiencies are important when the Agency seeks further regulatory or Major deficien tute immediate Sanitation soP failure uation involving a SSoP failure and a mis and FSIs Documentation is critical to the Agency's ability to successfully seek tuation must be deat with first and then the misrepresentation isst ublic health and safety always takes precedence over any other Minor deficiencies do not require official control act ACTIONS the plant and adequate documentation by FSIS. Th cementation to the Agencys ability to take regulatory against noncomplying plants cannot be BLOCK 9 Other After FSIS inspection personnel classify a deficiency using the DCG, involving a Sanitation SOP failure and possible they will determine if official control action is needed asi spectors will take action first on the contamination or adulteration is public health risk which priority over any other issues deficiencies always require official control action. This NOTE: If, at any time, FSIS inspection personnel suspect that equired records, offered for sale, sold, of transported inspection and prevent the use of facilities and equipment for production adulterated or misbranded meat or poultry products in until the failure is corrected commerce). they will report the aleged violations to the approprate Compliance Program OIC Critical deficiencies are also considered sanitation SoP failures To meet the regulatory requirements for a Sanitation SOP, the plant mus DECISIONS implement procedures to prevent direct product contamination or adulteration. Since a critical deficiency is one which is"certain to result Depending on the answer to the question"is official control action in direct product contamination or adulteration, it represents a failure eded or warranted? FSIS inspectors will proceed in one of two ways