FSMA affects producers, processors, and middlemen — such as storage facilities, transportation and hauling companies, and packaging producers of commodities — where the end product is for food consumption. For example, not only do nuts need to be tracked, but so do the almond hulls sold to a cattle operations for feed. Guidelines apply to different sectors and some sectors must adhere to more than one set of guidelines. Complete compliance will be mandatory in 2016. Until then, the FDA will continue to hold hearings to receive comments from affected parties in order to revise the law and make it practical for real-world application. Information on how FSMA applies to each type of business and open comment periods is available here.
The five elements of FSMA encompass preventative controls, inspection and compliance, imported food safety, response to occurrences of contamination, and enhanced partnerships with producers. The biggest change FSMA brings is the FDAs ability to enforce the law. Prior to FSMA, the FDA was not allowed to shut down producer facilities, even those with multiple health violations. The new regulation allows an FDA inspector to shut down a facility for a minimum of 30 days with only a suspicion of the possibility of a violation. If evidence of a violation is found, the FDA is able to shut down a facility for a longer period or even indefinitely.
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