A process validation study would establish the relationship between parameters such as process times and temperatures and other factors and the rate at which pathogens are reduced, and a prevalence study would determine the levels at which pathogens may occur in the raw material, ingredient, or animal food product to establish the cumulative amount of pathogen reduction that would be required to adequately reduce the risk of illness from that pathogen. Such studies are typically published or otherwise broadly disseminated within the scientific community and, when properly designed and carried out, are generally regarded by experts as scientifically definitive with respect to the matters addressed by the study. However, if scientific and technical information is not available or is insufficient to support the adequacy of a preventive control measure to control the hazard, the owner, operator or agent in charge of a facility would need to conduct controlled scientific studies to establish that a preventive control measure is adequate to control the hazard.
Information is available in the literature that can assist in the design of studies to support the adequacy of preventive control measures. For example, NACMCF has published information on "Parameters for Determining Inoculated Pack/Challenge Study Protocols" (Ref. 80). Studies to validate preventive control measures must be conducted by persons with experience and expertise relevant to the product, process and hazard to be controlled. Under proposed SEC 507.45(a)(1), any studies needed to provide the scientific and technical information to establish the validity of the plan would either be conducted by a qualified individual (as would be defined in proposed SEC 507.3) or would be overseen by a qualified individual. In other words, the qualified individual need not have the experience and expertise to conduct validation studies, but must have sufficient expertise in risk-based preventive controls to understand the studies and how they support the validity of the preventive controls with respect to the hazard of concern.
d. Proposed SEC 507.45(a)(3)--Preventive controls for which validation is not required. Proposed SEC 507.45(a)(3)(i) and (ii) would provide that validation need not address:
* The sanitation controls that would be established in proposed SEC 507.36(d)(2); and
* The recall plan that would be established in proposed SEC 507.38.
According to NACMCF, verification involves activities to determine the validity of the HACCP plan and that the system is operating according to the plan (Ref. 29). Thus, validation is a verification activity. The purpose of validation is to provide the scientific and technical basis for ensuring that the preventive controls implemented are adequate to control the hazards identified as reasonably likely to occur. FDA tentatively concludes that validation, i.e., the evaluation of scientific and technical information, is either not an essential activity, is not practical or is not relevant, for the controls identified in proposed SEC 507.45(a)(3).
As discussed in section X.C.6, proposed SEC 507.36(d)(2)(i)(A) would require that, where relevant to hazards that are reasonably likely to occur, sanitation controls include procedures for the cleanliness of animal food-contact surfaces, including food-contact surfaces of utensils and equipment. Traditionally, sanitarians employed by the facility, or experts employed by companies that supply cleaning and sanitizing compounds, will establish critical parameters and associated limits for cleaning and sanitation, including the choice and strength of the cleaning and sanitizing chemicals, contact time, and temperature requirements, based on studies conducted by the manufacturers of the products. Antimicrobial solutions applied to animal food processing equipment and utensils to sanitize such objects after they have been washed are included in the definition of "pesticide chemical" and therefore, are subject to regulation by EPA under section 408 of the FD&C Act. Chapter 4 (Additional Considerations for Antimicrobial Products) of EPA's "Pesticide Registration Manual" (Refs. 81 and 82) outlines EPA's requirements and recommendations for registration of antimicrobial substances, including testing against a validated protocol to be granted EPA-registered claims for pathogen reduction. Thus, FDA tentatively concludes that this proposed rule should not propose to require validation of the adequacy of the sanitation controls that would be required by proposed SEC 507.36(d)(2)(i)(A). Monitoring activities to ensure the procedures are followed will provide assurance that the controls are functioning as intended to prevent hazards from insanitary animal food-contact surfaces. The Agency requests comment on this approach.
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