The Codex animal food CGMPs provide that all means of transport should be appropriately cleaned to control and minimize the risk of contamination. Such vehicles should be subject to regular cleaning and sanitizing programs to ensure clean transport conditions and no accumulation of residual material (Ref. 2). The AAFCO Model animal food CGMPs provide that vehicles used to transport animal food be inspected for cleanliness and structural integrity prior to loading and that feed ingredients or other materials or substances that may pose a risk of adulterating feed or ingredients must not be loaded onto the same vehicle unless measures are taken to minimize such risk (Ref. 42).
C. Alternative To Establish Requirements in Place of Guidance in the Proposed Current Good Manufacturing Practices (CGMPs)
In this section, the Agency requests comment on whether non-binding (should) provisions in proposed subpart B of proposed part 507, should be changed to required (must) provision in the final rule.
The Agency believes that all of the proposed CGMP provisions, including the "should" provisions, are science-based and an important part of a modern food safety system. Because these non-binding provisions have been in place for decades for human food in current part 110, they are widely used and commonly accepted in many sectors of the human food industry. Similarly, the animal food industry is familiar with the principles behind these non-binding provisions. In addition, under section 418(o)(3) of the FD&C Act, the procedures, practices, and processes described in the definition of preventive controls may include sanitation procedures for food contact surfaces of utensils and equipment; supervisor, manager, and employee hygiene training; and CGMPs under part 110 (or any successor regulations).
The costs related to a fully mandatory sanitary operations, process, and controls program would be for the additional time that workers spend in compliance with those parts of proposed SUBSEC 507.19 and 507.20 that are changed from "should" to "must." That alternative, when implemented as part of a preventive approach, would impose incremental annual costs to qualified facilities. Those incremental costs have not been estimated due to a lack of data on current compliance with this alternative at those facilities and the incremental work efforts that would be required with these changes. Most non-qualified facilities would have met the requirements by following the requirements for sanitation controls in subpart C. Those that do not have hazards that are reasonably likely to occur or those with sanitation controls that do not fully address the requirements of the sanitary operations, however, would need to review their operations and implement additional procedures.
2. Summary of Alternative To Establish Requirements in Place of Guidance in the Proposed CGMPs
Table 1 identifies each of the potential differences in the CGMPs in proposed part 507 subpart B that would establish requirements (musts) instead of recommendations (shoulds) and either explains the reason for establishing the requirement or, for such differences with longer explanations, refers to the section where the potential requirement is explained.
Table 1--Alternative To Establish Requirements in Place of Guidance in the Proposed CGMPs Proposed Alternative to establish a Basis for requirement designation requirement (must) in place of a recommendation (should) (emphasis added)