The FDA Food Safety Modernization Act (FSMA), became law on January 4, 2011. On September 29, 2014, the FDA published for comment several proposed rules implementing the FSMA.
Any interested party has until December 15, 2014 to provide comments to the proposed rules. Two of these rules will have a direct impact on local manufacturers subject to FDA authority:
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls
- In response to the numerous comments received in response to the FDA’s 2013 proposed rule, the FDA seeks comment on the requirements to include in a final rule for product testing programs, environmental monitoring programs, supplier programs, and hazards intentionally introduced for economic gain. The FDA also proposes that “small businesses” (less than 500 persons) must comply with the rules within two years from implementation and “very small businesses” (less than $1MM/yr. in total sales of human food) must comply within three years.
Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- The FSVP proposes to require importers of foreign foods to engage in hazard analysis and supplier verification in order to help ensure that foreign-supplied foods offer the same level of public health protection as domestic foods. The FDA proposes a new hybrid approach to supplier verification, based on the risk that a hazard may cause serious injury or death.