2. Proposed Requirements for Validation
a. Proposed SEC 507.45(a)--Validation that preventive controls are adequate to control the hazard. Proposed SEC 507.45(a) would require that, except as provided by paragraph (a)(3), the owner, operator, or agent in charge of a facility validate that the preventive controls identified and implemented in accordance with SEC 507.36 to control the hazards identified in the hazard analysis as reasonably likely to occur are adequate to do so. Proposed SEC 507.45(a) would implement section 418(f)(1) of the FD&C Act. A discussion on validation and how it is used in HACCP systems can be found in the proposed rule for preventive controls for human food (78 FR 3646).
b. Proposed SEC 507.45(a)(1)--Validation by a qualified individual prior to implementation and on reanalysis. Proposed SEC 507.45(a)(1) would require that the validation of the preventive controls be performed (or overseen) by a qualified individual. The preventive controls must be adequate to control the hazards identified in the hazard analysis as reasonably likely to occur. Determining whether specific preventive controls are adequate requires an individual who is knowledgeable in the hazards associated with a product and process and the appropriate preventive controls for those hazards. Such knowledge requires scientific and technical expertise developed through training, experience or both.
Proposed SEC 507.45(a)(1)(i) would require that validation occur prior to implementation of the food safety plan or, when necessary, during the first six weeks of production. The validation of preventive controls includes collecting and evaluating scientific and technical information (or, when such information is not available or is insufficient, conducting studies), as discussed in the next section of this document. The collected data or information, or the studies, would establish a scientific and technical basis for the preventive controls used, in particular those that involve critical control points. This scientific and technical basis largely must be established prior to producing a product to ensure that the animal food produced using those preventive controls will be safe. However, as a practical matter, the scientific and technical basis for some aspects of a preventive control may require production conditions and, thus, would be established by the collection of data or information during, rather than before, producing a product. For example, ensuring that limits for control parameters can be met during production would be done under production conditions. FDA tentatively concludes that preventive controls that require the collection of data or information, or studies, during production conditions are part of validation, and, thus proposed SEC 507.45(a)(1)(i) would require that the validation of preventive controls be performed, when necessary, during the first 6 weeks of production. The Agency selected six weeks as a time interval that would be adequate to allow facilities to methodically collect data and information during production, yet would be close to implementation of a preventive control.
FDA requests comment on whether the proposed timeframe for validation should be shorter or longer. Comments should provide the basis for an alternative timeframe.
Proposed SEC 507.45(a)(1)(ii) would require that the validation of the preventive controls be performed whenever a reanalysis of the food safety plan reveals the need to do so. The circumstances under which a reanalysis would be required are addressed in proposed SEC 507.45(e)(1). Proposed SEC 507.45(e)(2) would require that the owner, operator, or agent in charge of a facility complete such reanalysis and implement any additional preventive controls needed to address the hazard identified, if any, before the change in activities at the facility is operative, or, when necessary, during the first 6 weeks of production. All preventive controls established to address a hazard identified as reasonably likely to occur must have a scientific and technical basis; establishing that scientific and technical basis is a validation activity regardless of whether the preventive control is established in the facility's initial food safety plan or as a result of reanalysis of the food safety plan.
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