Food Safety and Inspection Service

[Federal Register: January 30, 1998 (Volume 63, Number 20)]
[Rule-S and Regulations] [Page 45621 -From the Federal Register Online via GPO Access [wais.access.gpo.govl[DOCID:fr3Oja98-3]]]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service
9 CFR Part 417
[Docket No. 97-074N] Contents of HACCP Plans
AGENCY: Food Safety and Inspection Service, USDA.
ACTION- Compliance with the HACCP system regulations.

SUMMARY: The Food Safety and Inspection Service is publishing this document to ensure that the owners and operators of federally inspected establishments are aware that its hazard analysis and critical control point (HACCP) system regulations require that an HACCP plan be a self-contained document. In particular, the Agency does not view references to good manufacturing practices, or establishment actions in accordance with good manufacturing practices as satisfying the requirements the contents of a HACCP plan. Among other things, an HACCP plan must list the critical control points for each food safety hazard reasonably likely to occur in the production process, the critical limits that must be met at each of the critical control points, and the procedures, and frequency with which they will be performed, that will be used to monitor each critical control point to ensure compliance with critical limits and to verify that the plan is being effectively implemented. An HACCP plan also must identify the corrective actions to be followed in response to deviations from critical limits at critical control points.------------------------------------------ - - ----------------- - -----------------------

Given the explicit requirements to list critical control points, critical limits, and monitoring and verification procedures and to develop and identify corrective actions, and the Agency's statement, in issuing part 417, that it was clarifying requirements for the identification of critical control points within a HACCP plan (61 FR 38825). FSIS is concerned that some industry members and consultants to industry think that they can comply with Sec. 417.2(C) by referring to good manufacturing practices, or establishment actions in accordance with good manufacturing practices. While FSIS has considered good manufacturing practices in developing some requirements that protect the public against livestock products and poultry products that are misbranded or economically adulterated (21 U.S.C. 453 and 601), the Agency has not adopted specific good manufacturing practices as part of its regulations.

The Agency is publishing this notice to ensure that the owners and operators of federally inspected establishments are aware that references to good manufacturing practices, or establishment actions in accordance with good manufacturing practices, rather than stating the critical control points, critical limits, monitoring and, verification procedures, and corrective actions themselves is insufficient to satisfy the requirements of Sec. 417.5(c). part 417 requires that a HACCP plan be a self-contained document.

Moreover, the function of critical control points and critical limits is to prevent, eliminate, or reduce to an acceptable level one or more food safety hazards. By definition, critical limits are maximum and minimum values (Sec. 417.1). and by regulation, critical limits must be designed, at a minimum, to ensure that applicable targets or performance standards established by FSIS, and any other requirement in FSIS's regulations (9 CFR chapter 111) pertaining to the specific process or product, are met (Sec. 417.2(c)(3)), To determine whether critical limits are met and, if not, prevent the distribution of adulterated food and future deviations, the regulations require planspecific monitoring, verification, and corrective action procedures.

Done at Washington, DC, on: January 26, 1998.
Thomas J. Billy, Administrator.

[FR Doc. 98-2296 Filed 1-29-98; 8:45 am]

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