FDA Guidance Explains Certain Exemptions from FSMA

If you are a food producer covered by FDA’s regulations for low-acid canned foods, juice HACCP, or seafood HACCP, how do the rules that implement the FDA Food Safety Modernization Act (FSMA) affect you?

To answer this question, the FDA has published three guidances to help producers of food commodities covered by these earlier regulations understand which parts of the FSMA rules apply to them and how the FSMA rules may affect their operations.

FDA’s HACCP (Hazard Analysis and Critical Control Point) and Low-Acid Canned Foods (LACF) regulations were in place long before FSMA's rules became final. FDA’s HACCP regulations for juice and seafood processors require processors to perform a hazard analysis and develop a HACCP plan to address biological, chemical, and physical hazards, monitor the conditions and practices, and make corrections as needed. FDA’s low-acid canned foods regulation addresses biological hazards such as Clostridium botulinum unique to such foods, which include canned vegetables.

FSMA recognizes that FDA has previously-established regulations that are specific to seafood, juice, and LACF and so some exemptions have been made in the FSMA rules for these products. However, there are still some requirements in the FSMA regulations that apply to processors of the seafood, juice, and LACF products.

The new guidances aim to help the industry identify these exemptions and understand the juice, seafood, and LACF regulations in connection with some of the new FSMA requirements. The overarching goal of many of the new FSMA requirements is to reduce the number of foodborne illnesses attributed to the preventable contamination of FDA-regulated food products.

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