On November 13, 2015, the U.S. Food and Drug Administration (FDA) finalized and released several new rules related to food safety. The new rules primarily deal with produce farm safety standards and with imported foods. They account for three of the FDA’s seven rules implementing the Food Safety Modernization Act. Previously, the FDA released rules on preventive controls both for human food and animal food. Still to be released are rules on sanitary food transportation and on protecting food against intentional adulteration. Below is a summary of the three newly released rules.

Produce safety. For the first time, produce growth, harvesting, packing, and holding will be subject to minimum federal safety standards. This rule refines the FDA’s 2013 proposed rule on produce safety and takes into account comments from businesses concerned about the financial burden of new regulations. The grace period for compliance varies depending on the size of the produce farm, with larger farms having less time to get in compliance. Several items addressed by the rule include:

  • Water quality and testing – The FDA has created criteria for water quality and is mandating testing of water for E. coli at frequency levels based on the water’s source.
  • Raw manure and compost – The rule sets limits on detectable amounts of certain bacteria in compost. It also establishes that raw manure on organic fields may continue to be used up to 90 days before harvest.
  • Sprouts – The FDA includes specific requirements for sprouts as they have recently been the subject of illness outbreaks and are considered especially susceptible to dangerous bacteria.
  • Animals – Farms are not required to exclude animals from growing areas, but standards are now in place for grazing animals, working animals, and intrusion by wild animals.
  • Cleanliness – The rule puts requirements on produce worker hygiene and also requires training for the same. In addition, the rule sets standards on equipment, tools, and buildings to prevent produce contamination.

Foreign supplier verification. In addition to focusing on domestic produce, the FDA took steps to make sure imported foods meet its safety standards. This rule puts the onus on importers, requiring them to undertake minimum risk-based steps to confirm that imported foods meet U.S. standards. Importers will be required to establish and implement written procedures along these lines, although they are given flexibility based on the type of food and the foreign supplier’s past history. In the event that the importer determines a supplier is not meeting required standards, the importer must take corrective action, which can include ceasing to use the supplier until the underlying issue is resolved. Importers will be required to identify and evaluate foreseeable hazards and ensure that the suppliers are minimizing them. Evaluations can include annual on-site audits of the supplier’s facilities, sampling/testing, review of supplier safety records, or reliance on another appropriate verifying entity. The FDA is currently developing guidance to assist importers with compliance.

Accredited third-party certification. As part of the imported food safety initiative mentioned above, this rule creates an accreditation program involving third-party certification bodies, known as “auditors.” The auditors would determine whether a foreign supplier meets applicable FDA safety requirements via unannounced audits and certify compliance, allowing reliance by a domestic importer. The rule sets forth the requirements for FDA accreditation of an auditor as well as the ongoing compliance requirements. An accredited auditor may be a foreign government, foreign agency, or other third-party entity such as a corporation.

As the FDA will be regulating in a new area, they may have a bumpy road internally at the outset. Nonetheless, produce farmers and U.S. importers of foreign food should begin planning to be in compliance once the new rules take effect. If our firm can be of assistance regarding FDA rules and regulations, please feel free to contact Kyle Gilster or Charles Fleischmann.