61 FR 38868, July 25, 1996, unless otherwise noted.
For purposes of this part, the following definitions shall apply:
Corrective action. Procedures to be followed when a deviation occurs.
Critical control point. 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.
Critical limit. The maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.
Food safety hazard. Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.
HACCP System. The HACCP plan in operation, including the HACCP plan itself.
Hazard. SEE Food Safety Hazard.
Preventive measure. Physical, chemical, or other means that can be used to control an identified food safety hazard.
Process-monitoring instrument. An instrument or device used to indicate conditions during processing at a critical control point.
Responsible establishment official. The individual with overall authority on-site or a higher level official of the establishment.
(a) Hazard analysis.
(1) Every official establishment shall 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. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.
(2) A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified.
(3) Food safety hazards might be expected to arise from the following:
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(v) Drug residues;
(vi) Zoonotic diseases;
(ix) Unapproved use of direct or indirect food or color additives; and
(x) Physical hazards.
(b) The HACCP plan.
(1) Every establishment shall develop and implement a written HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section, including products in the following processing categories:
(i) Slaughter - all species.
(ii) Raw product - ground.
(iii) Raw product - not ground.
(iv) Thermally processed - commercially sterile.
(v) Not heat treated - shelf stable.
(vi) Heat treated - shelf stable.
(vii) Fully cooked - not shelf stable.
(viii) Heat treated but not fully cooked - not shelf stable.
(ix) Product with secondary inhibitors - not shelf stable.
(2) A single HACCP plan may encompass multiple products within a single processing category identified in this paragraph, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in paragraph (c) of this section are essentially the same, provided that any required features of the plan that are unique to a specific product are clearly delineated in the plan and are observed in practice.
(3) HACCP plans for thermally processed/commercially sterile products do not have to address the food safety hazards associated with microbiological contamination if the product is produced in accordance with the requirements of part 431 of this chapter.
(c) The contents of the HACCP plan. The HACCP plan shall, at a minimum:
(1) List the food safety hazards identified in accordance with paragraph (a) of this section, which must be controlled for each process.
(2) 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;
(3) List the critical limits that must be met at each of the critical control points. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met;
(4) List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;
(5) Include all corrective actions that have been developed in accordance with § 417.3(a) of this part, to be followed in response to any deviation from a critical limit at a critical control point; and
(6) Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.
(7) List the verification procedures, and the frequency with which those procedures will be performed, that the establishment will use in accordance with § 417.4 of this part.
(d) Signing and dating the HACCP plan.
(1) The HACCP plan shall be signed and dated by the responsible establishment individual. This signature shall signify that the establishment accepts and will implement the HACCP plan.
(2) The HACCP plan shall be dated and signed:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) At least annually, upon reassessment, as required under § 417.4(a)(3) of this part.
(e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an establishment to develop and implement a HACCP plan that complies with this section, or to operate in accordance with the requirements of this part, may render the products produced under those conditions adulterated.
(a) The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure:
(1) The cause of the deviation is identified and eliminated;
(2) The CCP will be under control after the corrective action is taken;
(3) Measures to prevent recurrence are established; and
(4) No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce.
(b) If a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment shall:
(2) Perform a review to determine the acceptability of the affected product for distribution;
(3) Take action, when necessary, with respect to the affected product to ensure that no product that is injurious to health or otherwise adulterated, as a result of the deviation, enters commerce;
(4) Perform or obtain reassessment by an individual trained in accordance with § 417.7 of this part, to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan.
(a) Every establishment shall validate the HACCP plan's adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented.
(1) Initial validation. Upon completion of the hazard analysis and development of the HACCP plan, the establishment shall conduct activities designed to determine that the HACCP plan is functioning as intended. During this HACCP plan validation period, the establishment shall repeatedly test the adequacy of the CCP's, critical limits, monitoring and recordkeeping procedures, and corrective actions set forth in the HACCP plan. Validation also encompasses reviews of the records themselves, routinely generated by the HACCP system, in the context of other validation activities.
(2) Ongoing verification activities. Ongoing verification activities include, but are not limited to:
(i) The calibration of process-monitoring instruments;
(ii) Direct observations of monitoring activities and corrective actions; and
(iii) The review of records generated and maintained in accordance with § 417.5(a)(3) of this part.
(i) Reassessment of the HACCP plan. Every establishment shall reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; personnel; packaging; finished product distribution systems; or, the intended use or consumers of the finished product. The reassessment shall be performed by an individual trained in accordance with § 417.7 of this part. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan no longer meets the requirements of § 417.2(c) of this part.
(ii) Each establishment must make a record of each reassessment required by paragraph (a)(3)(i) of this section and must document the reasons for any changes to the HACCP plan based on the reassessment, or the reasons for not changing the HACCP plan based on the reassessment. For annual reassessments, if the establishment determines that no changes are needed to its HACCP plan, it is not required to document the basis for this determination.
(b) Reassessment of the hazard analysis. Any establishment that does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur shall reassess the adequacy of the hazard analysis whenever a change occurs that could reasonably affect whether a food safety hazard exists. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; packaging; finished product distribution systems; or, the intended use or consumers of the finished product.
(a) The establishment shall maintain the following records documenting the establishment's HACCP plan:
(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation;
(2) The written HACCP plan, including decisionmaking documents associated with the selection and development of CCP's and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.
(3) Records documenting the monitoring of CCP's and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment's HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.
(b) Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.
(c) Prior to shipping product, the establishment shall review the records associated with the production of that product, documented in accordance with this section, to ensure completeness, including the determination that all critical limits were met and, if appropriate, corrective actions were taken, including the proper disposition of product. Where practicable, this review shall be conducted, dated, and signed by an individual who did not produce the record(s), preferably by someone trained in accordance with § 417.7 of this part, or the responsible establishment official.
(d) Records maintained on computers. The use of records maintained on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.
(e) Record retention.
(1) Establishments shall retain all records required by paragraph (a)(3) of this section as follows: for slaughter activities for at least one year; for refrigerated product, for at least one year; for frozen, preserved, or shelf-stable products, for at least two years.
(2) Off-site storage of records required by paragraph (a)(3) of this section is permitted after six months, if such records can be retrieved and provided, on-site, within 24 hours of an FSIS employee's request.
(f) Official review. All records required by this part and all plans and procedures required by this part shall be available for official review and copying.
A HACCP system may be found to be inadequate if:
(a) The HACCP plan in operation does not meet the requirements set forth in this part;
(b) Establishment personnel are not performing tasks specified in the HACCP plan;
(c) The establishment fails to take corrective actions, as required by § 417.3 of this part;
(d) HACCP records are not being maintained as required in § 417.5 of this part; or
(e) Adulterated product is produced or shipped.
(a) Only an individual who has met the requirements of paragraph (b) of this section, but who need not be an employee of the establishment, shall be permitted to perform the following functions:
(1) Development of the HACCP plan, in accordance with § 417.2(b) of this part, which could include adapting a generic model that is appropriate for the specific product; and
(2) Reassessment and modification of the HACCP plan, in accordance with § 417.3 of this part.
(b) The individual performing the functions listed in paragraph (a) of this section shall have successfully completed a course of instruction in the application of the seven HACCP principles to meat or poultry product processing, including a segment on the development of a HACCP plan for a specific product and on record review.
FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP plan meets the requirements of this part and all other applicable regulations. Such verification may include:
(a) Reviewing the HACCP plan;
(b) Reviewing the CCP records;
(c) Reviewing and determining the adequacy of corrective actions taken when a deviation occurs;
(d) Reviewing the critical limits;
(e) Reviewing other records pertaining to the HACCP plan or system;
(f) Direct observation or measurement at a CCP;
(g) Sample collection and analysis to determine the product meets all safety standards; and
(h) On-site observations and record review.