|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
ISSUE: What actions must owners and operators of federally inspected establishments take to comply with the requirement to review the records associated with production of a product prior to its shipment? In particular, can an establishment satisfy the requirement for a final, records-based verification by using any procedure other than one in which a single reviewer looks at all the records for the product as it is assembled on the shipping dock and loaded for transportation from the establishment?
To ensure that HACCP plans are implemented effectively and function as intended to control food safety hazards and prevent the distribution of adulterated livestock products and poultry products, part 417 requires that establishments conduct validation and verification activities. Verification includes review of the records that the establishment must keep to document a HACCP plan in operation. For a particular product, verification does not end until, in accordance with § 417.5(c), the establishment has reviewed the records associated with its production.
While the regulations do not prescribe how establishments meet this requirement and, thus, are sufficiently flexible to accommodate various records review schemes, establishments must determine that all critical limits were met and, when appropriate, corrective actions were taken and must otherwise ensure the completeness of their records before shipping the product for distribution. The essence of § 417.5(c) is to require that establishments take responsibility not only for developing and implementing HACCP plans, but also for maintaining control of products until they ensure that establishment personnel have applied those plans appropriately and effectively.
FSIS has not prescribed how establishments comply, and it views the regulations as sufficiently flexible to accommodate records review schemes in addition to the procedure described in the previous paragraph. Establishment personnel can review production records at any point after processing and before shipment of the product, including, for example, at the end of the day of production before a product goes into on-site storage, while a product is in on-site storage, or during preparation of shipping documents before assembling product for transportation from the establishment.
Consistent with the regulations, an establishment also can initiate checks for records completeness earlier and accomplish the review in stages. For example, an establishment that slaughters and bones cattle carcasses one day and prepares ground beef the next could make one reviewer responsible for performing slaughter and boning records review on the first day and carry the review forward to the second day, when another reviewer assumes responsibility for the remaining tasks necessary to ensure that there has been an establishment determination that all critical limits were met and, if appropriate, corrective actions were taken and that production records are otherwise complete and then signs and dates the review. In addition, establishments that maintain records on computers in accordance with § 417.5(d) may be able to accomplish much of the record checking electronically.
The crucial concern is that establishment controls have ensured proper product disposition, so that adulterated product is not distributed. FSIS has not, at this point, ruled out the possibility that a company might operate in compliance with this regulation despite the fact that records-based verification still is being conducted when the company transfers a product from the preparation establishment to another, storage location and holds the product there, maintaining control of the product until the company completes the review and releases the product for shipment to retail outlets. Industry members interested in instituting a records review scheme that includes this type of feature may wish to consult with the Agency about the types of safeguards needed to ensure that product is not shipped for distribution until the required verification has been performed. (Establishment compliance with part 417 requirements does not affect the applicability of other requirements and restrictions, including the prohibitions in section l0(c)(1) of the FMIA or section 9(a)(2)(A) of the PPIA.)
FSIS officials have taken the positions set out in this paper in discussions with members of the public. A draft Federal Register notice is in the clearance process.
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