Final Report Of An Audit Conducted In The United States February 5th, through February 22nd, 2013 Evaluating The Food Safety Systems Governing The Production Of Meat And Poultry Products Intended For Export To Canada
6. Sanitation Controls

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The inspection system must contain requirements for sanitation, for sanitary handling of products, and for the development and implementation of sanitation standard operating procedures (SSOP). The pre-operational and operational sanitation standard operating procedures should minimize direct and indirect contamination of meat products to the greatest extent possible. A properly implemented sanitation program shall ensure that establishment, facilities, and equipment are clean and sanitized prior to the start of operations, and includes the operational sanitation procedures, which will ensure that the appropriate hygiene is maintained during operations.

During the on-site portion of the audits, several observations were noted related to the verification by the USDA inspection staff of effective implementation of sanitation procedures. Observations related to pre-operational and operational sanitation procedures in addition to sanitary design of equipment were observed in several food processing areas. Some of them were more serious in nature as product being produced was directly affected.

In those situations, both USDA-FSIS auditors and local inspection staff reacted appropriately to the non-compliance. Establishments developed and implemented corrective actions and preventive measures addressing the concerns identified during the audit.

In one establishment producing RTE meat products, it was learned by the CFIA auditors that the room where exposed RTE hot dogs are packaged was allowed to operate for periods of up to four (4) days without a full dismantling, cleaning, and sanitization of the room and equipment.

FSIS Response:

IPP are to verify that establishments that choose to use a Less Than Daily (LTD) sanitation frequency are satisfying all of the regulatory requirements regarding sanitation. IPP are to verify that the establishment maintains compliance with 9 CFR 416.1 through 416.5 for sanitation performance standards (SPS) and is meeting the regulatory requirements set out in 9 CFR 416.11 through 416.16 for Sanitation SOPs. IPP are also to verify that establishments have included their LTD sanitation procedure for processing operations in their food safety system (e.g., a prerequisite program, Sanitation SOP, or HACCP). Equipment such as continuous ovens may not require daily sanitation. If the establishment can justify LTD cleaning procedures, they must be able to support their decisions as part of the requirements to maintain their food safety system.

FSIS evaluates performance of individual IPP annually. Employee performance is documented using IPPS (In-Plant Performance System) Reviews. Supervisory personnel evaluate IPP knowledge and application of FSIS policies, requirements, procedures to achieve FSIS strategic goals at each assignment on an annual basis.

Additional information regarding Less than Daily (LTD) sanitation is outlined in:

  1. FSIS Directive 5000.1 PDF (285 kb)
  2. Public AskFSIS Q&As on LTD sanitation
  3. AskFSIS Q&As clarify LTD procedures are not acceptable in slaughter areas.

In addition to sanitation requirements in 9 CFR 416, RTE products are subject to additional specific sanitary requirements under 9 CFR 430 rule that require validation or testing to measure effectiveness of sanitation. Control of Lm procedures may be documented in HACCP, SSOP, or PR programs. Requirements vary according to which ALTERNATIVE the establishment produces a particular product. Requirements for each ALTERNATIVE are weighted per RISK of the particular product category. Deli hot dogs under ALTERNATIVE #3 are clearly in the highest risk category and subject to the most requirements. Each alternative (1, 2, or 3) has more stringent requirements associated with risk. See FSISDIR 10,240.4 and associated documents: See Attachment 1.1 "Control requirements for Lm", p. 17 of Lm Control Guidelines, 2012 PDF (1.05 mb). The FSIS Enforcement, Investigations and Analysis Officer (EIAO) conducts comprehensive food safety assessments (FSA) at establishments in which they consider all food safety aspects that relate to that establishment and its products, the nature and source of all materials received, the establishment's processes, and the environment of the establishment. The EIAO primarily focuses on the design and validity of the hazard analysis, HACCP plan; Sanitation Standard Operating Procedures (Sanitation SOPs), pre-requisite programs, testing programs, e.g., its generic E. coli written procedures; and any other programs that constitute the establishment's food safety system.

FSIS has verified that the establishment referenced above maintains compliance with 9 CFR 416.1 through 416.5 for sanitation performance standards (SPS) and is meeting the regulatory requirements set out in 9 CFR 416.11 through 416.16 for Sanitation SOPs. The establishment is following FSIS regulations identified for LTD sanitation programs as outlined in FSIS Directives 5000.1 and 5000.5. In addition to the establishment's evaluation of its own program and FSIS in-plant inspection personnel oversight of the program, an EIAO evaluated the program and its effectiveness during the last FSA at the establishment and found it to meet FSIS expectations of a LTD program.

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