For animal food, the Agency is not proposing some of the requirements in the human food CGMPs as proposed part 117. FDA tentatively concludes that certain requirements are necessary for ensuring the safety of animal food across the board, while other precautions may be important for some animal food facilities and not others, depending on the type of animal food handled at the facility, the species for which the animal food is intended, and whether human consumers could come into direct contact with the animal food, among other considerations. For example, the Agency is not proposing specific requirements for: Employees to wear certain types of outer garments; maintenance of gloves; wearing, hair nets, beard covers, etc.; confining certain activities to areas other than where animal food may be exposed or where equipment or utensils are washed; or specifying the foreign substances for which necessary precautions must be taken to protect against contamination of animal food, animal food-contact surfaces, or animal food packaging materials. The animal food proposed rule includes a general provision that would require the establishment to take any other necessary precautions to protect against contamination of animal food, animal food-contacts, or animal food packing materials. This broad provision would allow the individual facility to determine if it needed to use outer garments, hairnets, etc. for the particular animal food being manufactured, processed, packed, or held at that facility. FDA tentatively concludes that this approach is appropriate when considering the diversity of the animal food industry.
Both the PAS 222 and the Codex animal food CGMPs address these areas, requiring personal hygiene for employees and requiring that items such as jewelry be secured. Unlike this proposed rule, the PAS 222 and the Codex animal food CGMPs provide for protective clothing and hair coverings where appropriate (Codex) and fit for the purpose (Refs. 2 and 44).
Proposed SEC 507.14(b) would recommend that personnel responsible for identifying plant sanitation failures or animal food contamination should have a background of education or experience to provide a level of competency necessary for production of clean and safe animal food. It would also recommend that animal food handlers and supervisors receive appropriate training in proper food handling techniques, food-protection principals, and be informed about the risks of poor personal hygiene and insanitary practices. The PAS 222, the AAFCO Model animal food CGMPs, and the Codex animal food CGMPs all provide for training of personnel in their areas of responsibility. As discussed in section IX.C, FDA is requesting comment on whether to change the recommendations to requirements for education or training in proper food handling techniques and food-protection principles.
FDA is proposing in SEC 507.14(c) that responsibility for ensuring compliance with all requirements in subpart B be clearly assigned to competent supervisory personnel.
2. Proposed SEC 507.17--Plant and Grounds
Plant, as defined in proposed SEC 507.3, means the building or establishment or parts thereof used in connection with the manufacturing, processing, packing, or holding of animal food. FDA is proposing in SEC 507.17(a) that the area around a plant be maintained so that it does not serve as a source of contamination of animal food.