FDA Announces Enforcement Discretion of the Produce Safety Rule

Brian German Agri-Business, Regulation

The U.S. Food & Drug Administration (FDA) announced an enforcement discretion policy for certain crops under the requirements of the Produce Safety Rule portion of the Food Safety Modernization Act (FSMA).  FDA indicated in a guidance document that the agency would not be holding entities that are growing, harvesting, packing, or holding either winegrapes, hops, pulse crops, or almonds responsible for meeting the requirements set forth by the Produce Safety Rule.

enforcement discretionSeveral industry groups that have been affected by the announcement expressed appreciation the FDA has decided to exclude certain crops from compliance expectations.  “This is significant for the California almond industry.  The leadership at FDA has accepted the information and evidence that almonds are in fact rarely consumed raw,” Almond Alliance President Elaine Trevino said in a press release.  “We are pleased the FDA listened to the science and evidence that we presented and took the appropriate action in placing almonds on the rarely consumed raw list.”

The California Association of Winegrape Growers (CAWG) had also been working with the Oregon Winegrowers Association and the Washington Winegrowers Association to have winegrapes exempted from the Produce Safety Rule guidelines.  “This is great news for winegrape growers,” CAWG President John Aguirre said in a news release. “FDA recognizes the fact that winegrapes are not consumed raw and winegrape growers should be exempted from the Produce Safety Rule. CAWG will continue to work with Congress and FDA to make sure this exemption remains intact.”

The announcement of enforcement discretion comes as compliance inspections for large farms are set to begin relatively soon.  After receiving input from industry members and conducting its own analysis FDA has concluded that the commodities listed in the announcement have unique production circumstances and intended uses which reduce the likelihood for foodborne pathogens to pose a risk.  The agency will continue evaluating alternative rules that would better suit the unique qualities of winegrapes, hops, pulse crops, and almonds.

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Brian German

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Ag News Director, AgNet West