9 CFR Part 417 - HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS

The Food Safety and Inspection Service (FSIS) is proposing to amend the egg products inspection regulations by requiring official plants that process egg products (herein also referred to as “egg products plants” or “plants”) to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with the meat and poultry regulations. FSIS is proposing to eliminate those current regulatory provisions that are inconsistent with HACCP, Sanitation SOPs, and the proposed sanitation requirements. FSIS is also proposing to specify in the regulations that official plants are required to process egg products to be edible without additional preparation to achieve food safety. In addition, FSIS is proposing to: Provide for generic approval as part of the prior label approval system for egg products; make changes to labeling requirements for shell eggs consistent with those in the Food and Drug Administration's (FDA's) regulations; require special handling instructions on egg products; eliminate the requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment; incorporate egg products plants into the coverage of the “Rules of Practice” that the Agency follows when initiating administrative enforcement actions; and change the Agency's interpretation of the requirement for continuous inspection in agency law. FSIS is also announcing that it is seeking public comment on draft guidance designed to help small and very small plants producing egg products to meet the new regulatory requirements being proposed in this rulemaking. Should the rule become final, FSIS intends to finalize this guidance.

The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations to eliminate the requirements for both ready-to-eat (RTE) and not-ready-to-eat (NRTE) pork and pork products to be treated to destroy trichinae ( Trichinella spiralis ) because the regulations are inconsistent with the Hazard Analysis and Critical Control Point (HACCP) regulations, and because these prescriptive regulations are no longer necessary. If this supplemental proposed rule is finalized, FSIS will end its Trichinella Approved Laboratory Program (TALP program) for the evaluation and approval of non-Federal laboratories that use the pooled sample digestion technique to analyze samples for the presence of trichinae. FSIS is also proposing to consolidate the regulations on thermally processed, commercially sterile meat and poultry products ( i.e., canned food products containing meat or poultry).

The Food Safety and Inspection Service (FSIS) is announcing the availability of the final revision of the Compliance Guideline for Hazard Analysis Critical Control Point (HACCP) systems validation and responding to comments received on the draft guide that FSIS published in May 2013 in the Federal Register . In addition, FSIS is announcing its plans to verify that establishments meet all validation requirements.

The Food Safety and Inspection Service (FSIS) is announcing the availability of updated guidance for Hazard Analysis Critical Control Point (HACCP) systems validation. In addition, FSIS is announcing that it will hold a public meeting on June 25, 2013, to review changes to the guidance announced in this notice and to take comments. The public meeting will also be available by teleconference. Following the public meeting, the Agency will accept written comments until July 25, 2013. Given the extensive opportunity for comment on the guidance, however, the Agency believes that very few, if any, issues remain in this proceeding.

The Food Safety and Inspection Service (FSIS) is extending the comment period for the December 6, 2012, Federal Register document “HACCP Plan Reassessment for Not-Ready-to-Eat Comminuted Poultry Products and Related Agency Verification Procedures” until April 20, 2013. FSIS will also provide an additional 45 days for establishments that produce not-ready-to-eat (NRTE) comminuted chicken or turkey products to reassess their Hazard Analysis and Critical Control Points (HACCP) plans for those products. FSIS will postpone by 45 days the date inspection personnel will begin verifying that those establishments have reassessed their HACCP plans. In addition, starting approximately on April 20, 2013, the Agency intends to begin obtaining samples to determine the prevalence of Salmonella in NRTE comminuted poultry product announced in the document. The Agency is taking these actions in response to a request made by a coalition of trade associations.

The Food Safety and Inspection Service (FSIS) is publishing this notice to inform establishments producing not-ready-to-eat (NRTE) ground or otherwise comminuted chicken and turkey products that they must reassess their Hazard Analysis and Critical Control Points (HACCP) plans for these products to take into account several recent Salmonella outbreaks associated with consumption of comminuted NRTE turkey products. No sooner than 90 days following publication of this notice, Agency inspection program personnel (IPP) will begin verifying that establishments that manufacture comminuted NRTE turkey or chicken product, as a final or intermediary product for further processing as NRTE product, have reassessed their HACCP plans for these products. This notice also describes how FSIS will determine whether the association of NRTE meat or poultry product with an outbreak would make subsequently-produced like product adulterated. In addition, FSIS is expanding its Salmonella Verification Sampling Program for Raw Meat and Poultry product to include all forms of non-breaded, non-battered comminuted NRTE poultry product that are not destined under company control programs for further processing into RTE products in official establishments. Finally, this notice announces that FSIS will apply its Category 1 performance measure based on current performance standards for ground chicken and turkey product to comminuted poultry to mark the level of process control that all establishments producing such products should maintain. No sooner than 90 days after publication of this notice, the Agency will begin sampling to determine the prevalence of Salmonella in comminuted poultry and will use the results from this sampling to develop performance standards for these products. For reasons discussed later, FSIS has not tested NRTE comminuted poultry products, other than ground chicken and ground turkey, for Salmonella. In addition, FSIS is likely to develop Campylobacter standards for these products following validation of an analytic method. FSIS invites comments on this notice.

The Food Safety and Inspection Service (FSIS) is announcing that it is restructuring the United States National Residue Program (NRP) with respect to how sampling of chemical compounds and animal production and egg product classes is scheduled. To complement this new approach to sampling and scheduling, the Agency is implementing several multi-residue methods for analyzing samples of meat, poultry, and egg products for animal drug residues, pesticides, and environmental contaminants in its inspector-generated testing program. These modern, high-efficiency methods will conserve resources and provide useful and reliable results while enabling FSIS to analyze each sample for more chemical compounds than was previously possible.

The Food Safety and Inspection Service (FSIS) is confirming that it will implement routine verification testing for six Shiga toxin-producing Escherichia coli (STEC), in addition to E. coli O157:H7, in raw beef manufacturing trimmings beginning June 4, 2012. FSIS is also responding to comments on the final determination published September 20, 2011, in the Federal Register regarding the June 4, 2012, implementation of STEC sampling and related issues.

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.