FDA Finalizes Three New Rules Under FSMA

Nov 03, 2015 | Katie Regan

The Food and Drug Administration (FDA) has finalized three additional rules developed under the Food Safety Modernization Act (FSMA): Produce Safety, Foreign Supplier Verification, and Third Party Accreditation. The FSMA, passed more than four years ago, is a broad reform of the United States’ food safety system that focuses on prevention rather than reaction.

Broadly, the new rules for set guidelines for growing, harvesting, packing, and holding produce on farms; require foreign importers to verify that food has been produced under the same level of protections that would apply to domestic producers; and establish a program for accrediting third-party auditors. The rules have all been submitted to the Federal Register for publication.

Currently, one in six (or 48 million) Americans are sickened, 148,000 are hospitalized, and 3,000 die of preventable foodborne illnesses every year. The FSMA is expected to dramatically reduce those numbers.

Very small businesses have three years to comply with the rules; small businesses have two years; and all others have one year.

Two additional regulations associated with the law are pending finalization. A rule for sanitary transportation is expected to be complete by March 31, and a rule for intentional adulteration is due May 31.


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