The U.S. Food and Drug Administration (FDA) has finalized the first two major regulations developed under the Food Safety Modernization Act (FSMA)—the Preventative Controls for Human Food and Preventative Controls for Animal Food. 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 require food facilities to maintain a food safety plan, identify any hazards that could contaminate their products and lead to sickness, and institute preventative controls for dealing with identified hazards. Facilities are also required to verify and document that their controls are working. 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 new rules are 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.
Five additional regulations associated with the law are pending finalization. Rules for produce safety, foreign supplier verification program, and third-party accreditation must be finalized by October 31.