Institute for Food Laws and Regulations

Fortin, Neal D., Regulatory Requirements in the United States on Hygiene Control in the Design, Construction, and Renovation of Food Processing Factories (2011). Chapter 4 in Hygiene Control in the Design, Construction and Renovation of Food Processing Factories, Edited by: H. L. M. Lelieveld and John Holah (Woodhead Publishing Ltd. 2011). Available at SSRN: https://ssrn.com/abstract=2497425.

The regulatory requirements on hygiene control in the design, construction and renovation of food processing facilities in the United States are summarized. Food processing plants in the United States fall under the federal regulatory authority of the FDA or the USDA. However, state agencies play the major role in approval of hygienic plant design and in the enforcement of the standards. Additional government entities may be involved in a non-regulatory role, such as the USDA Dairy Program. An overview of the applicable federal statutes and regulations is provided, which generally specify performance requirements. The role of third party certifying organizations is explained, as well as the use of guidance and other recommendations. Finally, specific regulations for specialized processes, such as low-acid canning, are discussed.