On January 5, 2018, the U.S. Food and Drug Administration (FDA) issued guidance for industry covering enforcement discretion on four of the seven foundational rules established in Title 21 of the Code of Federal Regulations for the Food Safety Modernization Act (FSMA).

The four foundational rules cover:

• Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food;
• Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals;
• Foreign Supplier Verification Programs for Importers of Food for Humans and Animals;
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

The enforcement discretion will allow sufficient time to pursue future rulemaking for FDA with regards to preventive controls requirements for facilities.

The Federal Register Notice can be found here:

https://www.federalregister.gov/documents/2018/01/05/2018-00050/policy-regarding-certain-entities-subject-to-the-current-good-manufacturing-practice-and-preventive

 The FDA guidance can be found here:

https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM590661.pdf