This proposed rule would amend the 2013 proposed rule that would establish regulations for domestic and foreign facilities regarding the manufacturing, processing, packing, or holding of animal food. First, it would revise the proposed new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food. Second, it would add to the new preventive control provisions intended to implement section 103 of the FDA Food Safety Modernization Act (FSMA) for animal food.
In general, with some exceptions the new preventive control provisions would still apply to animal food facilities that are required to register with FDA under FDA’s current food facility registration regulations. Specifically, the new preventive controls would include requirements that address product testing, environmental monitoring, a supplier program and economically-motivated adulteration. Additionally, the proposed rule includes a very small business definition as those with annual sales of animal food products of less than $2.5 million.
Regulatory Impact Analysis
Federal Register: 79 FR 58475, September 29, 2014