The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the FDA to better protect public health by helping to ensure the safety and security of the food supply. It requires FDA to promulgate food safety rules that focus on preventing food safety issues rather than relying on detecting issues and reacting to them after they occur.

FSMA recognizes that FDA has previously established a regulation that addresses biological hazards unique to low-acid foods packaged in hermetically sealed containers (i.e., “low-acid canned foods,” hereinafter referred to as LACF) [2] (Title 21, Code of Federal Regulations (21 CFR) part 113). See FSMA §§ 103(a), 103(f), 105(d), and 301 (§§ 418(j) and 805(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 350g(j), 350g note, 350h note, and 384a(e))).   

Importantly, several of the regulations that FDA has issued under FSMA provide exemptions that are related to the LACF requirements in part 113. This guidance, first issued in August 2017, addresses those exemptions, [3] and also provides information about the LACF regulation in part 113 in connection with the following FSMA regulations: 

• 21 CFR part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (the CGMP & PC Regulation)
• 21 CFR 1, subpart L, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (the FSVP Regulation)
• 21 CFR 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the PS Regulation)
• 21 CFR part 121, Mitigation Strategies To Protect Food Against Intentional Adulteration (the IA Regulation)
• 21 CFR 1, subpart O, Sanitary Transportation of Human and Animal Food (the ST Regulation)

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA’s guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Download the Guidance

---

Related Information

• FSMA Rules & Guidance for Industry
• Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information