On Friday, November 13, the Food and Drug Administration (FDA) finalized three new rules designed to increase food safety and prevent foodborne illnesses that will impact food supply chains.

The first rule, called the Produce Safety Rule, establishes “science-based” minimum standards for safe growing, harvesting, packing, and handling of fruits and vegetables grown for human consumption.  The Produce Safety Rule establishes mandatory requirements for water quality, the use of raw manure, treatment of sprouts, farm worker hygiene practices, sanitary standards for equipment, tools, and buildings, and preventing the contamination of fruits and vegetables by animals.  Compliance begins in one year, with all farms to be compliant within four years of implementation of the new rule.

The second rule is called the Foreign Supplier Verification Programs Rule, which imposes new requirements on companies that import food into the US.  Food importers will now be responsible for enacting “verification programs” to detect and control reasonably foreseeable hazards in connection with imported foods.  Importers must establish and follow written Foreign Supplier Verification Programs (FSVP) for each food that is brought into the US and must re-evaluate the risks controlled for in the FSVP at least one every three years.  Foreign supplier verification options identified by the FDA include (but are not limited to) annual on-site audits of foreign food supplier facilities, sampling and testing, and review of foreign supplier food safety records.  Importers are entitled to rely on third parties (auditors) to perform the verification required under the new rule, but must review and assess the relevant documentation.  The Foreign Supplier Verification Programs Rule also dictates that US food importers must establish corrective action programs to address food adulteration issues.  This rule goes into effect for most US food importers in 18 months.

The third rule is the Accredited Third-Party Certification Rule, which establishes a voluntary program for the accreditation of third-party auditors that conduct food safety audits of foreign operations that export food to the US.

These new rules are part of an ever-increasing FDA trend of trying to prevent illness and contamination before they start.  We will continue to update you with further developments!

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