3. Alternative to the Proposed CGMPs To Establish Requirements (Must) in Place of Guidance (Should) for Education and Training
Proposed SEC 507.14(b), provides guidance that personnel responsible for identifying sanitation failures or animal food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe animal food. Proposed
As discussed in section II.A.1 of the document for the proposed rule for preventive controls for human food (78 FR 3646), a CGMP Working Group Report identified specific areas that presented an opportunity to modernize the CGMP regulation for human food. One recommendation was to "require appropriate training for supervisors and workers to ensure that they have the necessary knowledge and expertise in food hygiene, food protection, employee health and personal hygiene to produce safe food products. This training must be delivered in a manner that can be easily understood by the worker. Food processors must maintain a record of this training for each worker" (Ref. 49). The Agency's analysis of human food recalls also indicates that ineffective employee training was a root cause of 32 percent of CGMP-related recalls in the 1999-2003 analysis (Ref. 50); deficiencies in training were identified as a contributing factor in 24 percent of CGMP-related primary recalls in the 2008-2009 analysis (Ref. 51). While the Agency does not currently have animal food CGMP regulations to enable it to analyze animal food recalls based on CGMP violations, it believes that these trends of recalls in the human food facilities due to ineffective employee training would be found in the animal food industry as well. In addition, as discussed with respect to the proposed definition of preventive controls (see section VIII.B), section 418(o)(3) of the FD&C Act recognizes the importance of both training and CGMPs in preventing hazards from occurring in foods in its definition of preventive controls, which identifies supervisor, manager, and employee hygiene training (section 418(o)(3)(B)) and CGMPs under part 110 (section 418(o)(3)(F)) as some of the procedures, practices, and processes that may be included as preventive controls.
The vast majority of costs related to a mandatory education and training program would be for the time that workers would be training rather than in production. Lacking data on the education and training programs offered by animal food production facilities, FDA used responses to a 2010 survey of human food production facilities to gauge training needs. The Agency estimates that this alternative, when implemented as part of a preventive approach, could impose an annual cost of
The Agency requests comment on how best to revise proposed SEC 507.14(b) in light of section 418(o)(3) of the FD&C Act and the recommendations of the human food
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