Source: https://www.law.cornell.edu/cfr/text/9/417.4
Timestamp: 2018-05-22 14:15:33
Document Index: 301771993

Matched Legal Cases: ['art 417', '§ 417', '§ 417', '§ 417', 'art 417', 'arts 417']

9 CFR 417.4 - Validation, Verification, Reassessment. | US Law | LII / Legal Information Institute
CFR › Title 9 › Chapter III › Subchapter E › Part 417 › Section 417.4
9 CFR 417.4 - Validation, Verification, Reassessment.
(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:
(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.
[ 61 FR 38868, July 25, 1996, as amended at 77 FR 26936, May 8, 2012]
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR Part 417 after this date.
2015-05-14; vol. 80 # 93 - Thursday, May 14, 2015
80 FR 27557 - HACCP Systems Validation
FR Doc. 2015-11581
78 FR 32184 - HACCP Systems Validation
FR Doc. 2013-12763
The public meeting will be held on June 25, 2013 from 8:30 a.m. to 12:30 p.m. On-site registration will begin at 8:00 a.m. Written comments may be submitted until July 25, 2013.
78 FR 14635 - HACCP Plan Reassessment for Not-Ready-To-Eat Comminuted Poultry Products and Related Agency Verification Procedures
FR Doc. 2013-05342
77 FR 72686 - HACCP Plan Reassessment for Not-Ready-To-Eat Comminuted Poultry Products and Related Agency Verification Procedures
FR Doc. 2012-29510
9 CFR Parts 417
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.
77 FR 39895 - New Analytic Methods and Sampling Procedures for the United States National Residue Program for Meat, Poultry, and Egg Products
FR Doc. 2012-16571
77 FR 27135 - HACCP Systems Validation
FR Doc. 2012-10895
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.
9 CFR 417.2 — Hazard Analysis and HACCP Plan.
9 CFR 417.3 — Corrective Actions.
9 CFR 430.4 — Control of Listeria Monocytogenes in Post-Lethality Exposed Ready-To-Eat Products.