FDA has issued two draft guidance documents to assist industry with the implementation of Preventive Controls and Current Good Manufacturing Practices under the Animal Food Rule and another draft guidance to assist businesses in determining whether the activities they perform are within the “farm” definition.

• The two Draft Guidance documents relating to the Animal Food Rule include:

  • Draft Guidance for Industry #235 – Current Good Manufacturing Practice Requirements for Food for Animals which is intended to assist facilities that manufacture, process, pack or hold animal food for consumption in the U.S. comply with Current Good Manufacturing Practices (CGMP) requirements in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, and holding and distribution.

  • Draft Guidance for Industry #239 – Human Food By-Products for Use as Animal Food which is designed to assist facilities that manufacture, process, pack or hold human food and then subsequently provide the human food by-products for use as animal food in determining what requirements in the Preventive Controls for Animal Food rule apply to their human food by-product.

• The Draft Guidance pertaining to the classification of activities for farms and facilities, available here, is intended to assist businesses determine whether the activities they perform are within the “farm” definition.  In general, businesses that only perform activities within the “farm” definition are not subject to the FSMA Preventive Controls for Human Food or Animal Food rules.  Rather, activities involving covered produce may be subject to the FSMA Produce Safety rule instead.

• All three draft guidance documents are available for public comment starting today, August 25, 2016.