FDA also requests comment on whether more detail would be appropriate, by, for example:
* Specifying that each person engaged in animal food manufacturing, processing, packing, or holding (including temporary and seasonal personnel and supervisors) receive training as appropriate to the person's duties;
* Specifying the frequency of training (e.g., upon hiring and periodically thereafter);
* Specifying that training include the principles of animal food hygiene and animal food safety, including the importance of employee health and personal hygiene, as applied at the facility; and
* Specifying that records document required training of personnel and, if so, specifying minimum requirements for the documentation (e.g., the date of the training, the type of training, and the person(s) trained).
The Agency also requests comment on whether to establish some or all of the potential requirements for education and training in subpart B, subpart C, or both. If the Agency establishes a requirement for education and training in subpart B, that requirement would apply to all persons who manufacture, process, pack, or hold animal food, with the exceptions of persons who would be exempt from subpart B (e.g., under proposed SEC 507.5(a) and (h), a requirement in subpart B would not apply to farms, or the holding or transportation of one or more raw agricultural commodities as defined in section 201(r) of the FD&C Act). On the other hand, if the Agency establishes a requirement for education and training in subpart C, that requirement would not apply to persons who would be exempt from the requirements of proposed subpart C (e.g., qualified facilities).
X. Proposed Subpart C--Hazard Analysis and Risk-Based Preventive Controls
A. Proposed SEC 507. 30--Requirement for a Food Safety Plan
1. Requirements of Section 418 of the FD&C Act
Section 418(h) of the FD&C Act requires that the owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of section 418 of the FD&C Act, including analyzing the hazards under section 418(b) of the FD&C Act and identifying the preventive controls adopted under section 418(c) of the FD&C Act] to address those hazards. Section 418(h) of the FD&C Act also requires such written plan, together with the documentation described in section 418(g) of the FD&C Act, shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.
2. Proposed SEC 507.30--Requirement for a Food Safety Plan
Proposed SEC 507.30(a) would specify that the owner, operator, or agent in charge of a facility must prepare, or have prepared, and implement a written food safety plan. The Agency uses the term "written food safety plan" in proposed SEC 507.30(a) to mean the "written plan" referred to in section 418(h) of the FD&C Act. To make clear that the written plan is related to animal food safety rather than to other plans a facility may have (such as quality control plans or food defense plans), the Agency has designated the "written plan" to be a "written food safety plan."
In drafting the proposed requirements for subpart C described in the paragraphs that follow, the Agency uses wording and formatting that is in some cases slightly different from analogous provisions in the proposed rule for preventive controls for human food published (78 FR 3646). Two types of differences are meant to be substantive: Those relating to ready-to-eat food and those relating to food allergens. Both of those concepts are not applicable in the animal food context. In addition, proposed subpart C of proposed part 507 addresses nutrient imbalances, which are relevant to animal food but not, for the most part, to human food. Otherwise, provisions in proposed subpart C of proposed 507 are meant to have the same meaning as the analogous provisions in proposed subpart C of proposed rule for human food.
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