Food Safety and Inspection Service May 2012 – Federal Register Recent Federal Regulation Documents

The Office of the Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), is sponsoring a public meeting on June 5, 2012. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions that will be discussed at the 35th Session of the Codex Alimentarius Commission (CAC), which will be held in Rome, Italy, July 2-7, 2012. The Under Secretary for Food Safety recognizes the importance of providing interested parties the opportunity to obtain background information on the 35th Session of the CAC and to address items on the agenda.

The Food Safety and Inspection Service (FSIS) is issuing this document to propose to clarify its requirements for validation by an official establishment of its Hazard Analysis Critical Control Point (HACCP) system, that is, validation of both the critical control points (CCPs) in the HACCP plan and any interventions or processes used to support decisions in the hazard analysis. Validation of a HACCP system involves two separate elements: The scientific or technical support for the judgments made in designing the HACCP system, and evidence derived from the execution of the HACCP plan to demonstrate that it is, in fact, achieving the critical operational parameters documented in the scientific or technical support. The Agency is also announcing the availability of, and requesting comments on, a revised draft guidance document prepared to assist establishments in appropriately validating their HACCP systems. The Agency received and analyzed comments on the initial draft of this guidance, which the Agency posted on its Web site in March 2010. FSIS is soliciting comments on this revised guidance and will hold a public meeting to discuss the revised guidance before it issues final guidance for HACCP systems validation.

The Food Safety and Inspection Service (FSIS) is announcing proposed new procedures that it intends to implement when FSIS or other Federal or State agencies find raw ground beef presumptive positive for Escherichia coli (E. coli) O157:H7. This methodology will enable FSIS to better determine whether the establishments that produced the source materials for contaminated product have produced other product that may not be microbiologically independent from the contaminated product. The Agency is also announcing its intention to now, as a matter of routine policy, request a recall if an establishment was the sole supplier of beef trim source materials for ground product that FSIS or other Federal or State agencies find positive for E. coli O157:H7, evidence suggests that contamination most likely occurred at the supplier establishment, and a portion of the product from the originating source lot was sent to other establishments. This notice also explains that FSIS intends to determine whether it can make better use of establishment results and also intends to conduct a study to help it identify the source of E. coli O157:H7 positive ground beef when the material from multiple suppliers was used to produce positive product. Finally, this notice announces the availability of compliance guidelines concerning establishment sampling and testing for shiga toxin-producing E. coli (STEC) organisms or virulence markers and compliance guidelines for E. coli O157:H7 sampled and tested labeling claims.