[Federal Register Volume 63, Number 20 (Friday, January 30, 1998)] [Rules and Regulations] [Pages 4560-4562] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-2297] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 417 [Docket No. 97-082N] Contents of HACCP Plans; Critical Control Points AGENCY: Food Safety and Inspection Service, USDA. ACTION: Compliance with the HACCP system regulations. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing this document to ensure that the owners and operators of federally inspected establishments are aware that the identification of appropriate critical [[Page 4561]] control points is crucial to complying with the Agency's regulations on hazard analysis and critical control point (HACCP) systems. The HACCP system regulations require that a HACCP plan list critical control points for each food safety hazard identified as reasonably likely to occur in the production process. The number of critical control points will depend upon the production process and the hazard, but a HACCP plan must specify as critical control points the points, steps, or procedures at which control can be applied and, as measured by critical limits, occurrence of the hazard can be prevented, eliminated, or reduced to an acceptable level, and at a minimum, the critical limits must be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement in the Agency's regulations pertaining to the specific process or product, are met. These requirements implement FSIS's judgment that whenever a food safety hazard is reasonably likely to occur in the production process, by applying control measures, the establishment can at least reduce the hazard to an acceptable level, even if it cannot entirely prevent or eliminate its occurrence. FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy Administrator, Regulations and Inspection Methods, Food Safety and Inspection Service, Washington, DC 20250-3700; (202) 205-0699. SUPPLEMENTARY INFORMATION: The Food Safety and Inspection Service (FSIS) administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) to protect the health and welfare of consumers by preventing the distribution of livestock products and poultry products that are unwholesome, adulterated, or misbranded. To further the goal of reducing the risk of foodborne illness from meat and poultry products to the maximum extent possible, FSIS issued the Pathogen Reduction-Hazard Analysis and Critical Control Point (HACCP) Systems final rule (61 FR 38806, July 25, 1996). The HACCP system regulations, part 417,1 require that every federally inspected establishment conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards (Sec. 417.2(a)). Whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, the establishment must develop and implement a HACCP plan, or plans, to control those hazards (Sec. 417.2(b)). Although it is possible that a hazard analysis conducted in accordance with the regulations will reveal no food safety hazard that is reasonably likely to occur, as the Agency stated when it issued the regulations, FSIS is not aware of any meat or poultry production process that can be deemed, categorically, to pose no likely hazards (61 FR 38824).2 --------------------------------------------------------------------------- \1\ Part 417 requirements will apply as of January 26, 1998, in establishments with 500 or more employees; January 25, 1999, in establishments with 10 or more but fewer than 500 employees (unless the establishment has annual sales of less than $2.5 million); and January 25, 2000, in establishments with fewer than 10 employees or annual sales of less than $2.5 million. \2\ Food safety hazards include any biological, chemical, or physical property that may cause a food to be unsafe for human consumption (Sec. 417.1). --------------------------------------------------------------------------- For purposes of part 417, a critical control point (CCP) is a point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels (Sec. 417.1).) Every HACCP plan must ``list the critical control points for each of the identified food safety hazards, including, as appropriate:'' (i) Critical control points designed to control food safety hazards that could be introduced in the establishment, and (ii) Critical control points designed to control food safety hazards introduced outside the establishment, including food safety hazards that occur before, during, and after entry into the establishment * * * (Sec. 417.2(c)(2)). The plan also must comply with the related requirements to specify the critical limits (maximum and minimum values) to be met at CCP's, the corrective actions to be followed in response to deviations from critical limits at CCP's, and the monitoring and verification procedures to ensure appropriate corrective actions if and when those deviations occur (Secs. 417.1, 417.2(c), 417.3(a), and 417.4(a)). At a minimum, critical limits must be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement in FSIS's regulations (9 CFR chapter III) pertaining to the specific process or product, are met (Sec. 417.2(c)(3)). It has come to FSIS's attention that in developing HACCP plans, some persons are viewing CCP's so narrowly that they risk noncompliance with regulatory requirements. FSIS is concerned that some establishments may be relying solely on HACCP concepts and theory, without evaluating CCP's in accordance with regulatory requirements. The Agency is publishing this notice to ensure that the owners and operators of federally inspected establishments are aware that the identification of appropriate critical control points is crucial. The number of critical control points will depend upon the production process and the hazard. FSIS will treat failure to specify at least one CCP for each food safety hazard identified in accordance with the regulations as reasonably likely to occur as a failure to develop and implement a HACCP plan that complies with Sec. 417.2 (Sec. 417.2(e)). The only exception, as specified in Sec. 417.2(b)(3), is for food safety hazards associated with microbiological contamination: HACCP plans that cover thermally processed/commercially sterile products produced in accordance with the current canning regulations (part 318, subpart G, or part 381, subpart X) need not, at this time, address microbial hazards.3 --------------------------------------------------------------------------- \3\ FSIS intends to convert the canning regulations to performance standards, which are more consistent with HACCP (61 FR 38824). --------------------------------------------------------------------------- FSIS anticipates that to operate in accordance with part 417, many establishments will find that for each identified hazard, they need more than one CCP, particularly if they are producing raw products. The Agency believes that depending upon a single CCP increases establishment exposure to production-disrupting corrective actions that affect large amounts of product. While FSIS is not prepared to say that compliance cannot be achieved with a single CCP when, for example, a product is treated sufficiently to be shelf stable, even though it is not commercially sterile, the Agency is concerned that establishments may be viewing CCP's too restrictively to ensure compliance with the regulations. The part 417 requirements addressed in this notice implement the Agency's conclusion that whenever a food safety hazard is reasonably likely to occur in the production process, even if an establishment cannot entirely prevent or eliminate occurrence of the hazard, by applying control measures, the establishment can at least reduce it to an acceptable level. Part 417 requires all federally inspected establishments to take the prudent, preventive approach and develop systematic measures for controlling such hazards. [[Page 4562]] Done at Washington, DC, on: January 26, 1998. Thomas J. Billy, Administrator. [FR Doc. 98-2297 Filed 1-29-98; 8:45 am] BILLING CODE 3410-DM-P