FDA Issues Guidances on Exemptions from FSMA Rules
As previously reported on this blog, the U.S. Food and Drug Administration issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA) on September 10, 2015. Prior to issuing the FSMA regulations, FDA established:
A Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, (Title 21, Code of Federal Regulations (C.F.R.) Part 123)
A Juice HACCP regulation, (21 C.F.R. Part 120)
A regulation that addresses biological hazards unique to low-acid foods packaged in hermetically sealed containers (i.e., “low-acid canned foods), (21 C.F.R. Part 113)
While some exemptions were made in the FSMA rules for the above products, some requirements in the FSMA regulations still apply. FDA issued three guidances that clarify which parts of the FSMA rules apply to producers of low-acid canned foods, juice, and seafood. The guidances are:
The new guidances are intended help industry understand the juice, seafood, and canned low-acid foods regulations in connection with some of the new FSMA requirements and to identify the exemptions for these products.