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On 28 March 2019, the Food and Drug Administration (FDA) announced the availability of a guidance for industry conveying FDA's intent to exercise enforcement discretion concerning the requirements of the Produce Safety Regulation under the Food Safety Modernization Act (FSMA) (Pub. L. 111-353). Comments on the new guidance may be submitted at any time.
Verisk 3E Review
The guidance for industry entitled, “Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds" (guidance) states the intent of FDA to exercise enforcement discretion regarding the requirements of the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” regulation (Produce Safety Regulation) as they apply to entities growing, harvesting, packing, and holding hops, wine grapes, pulse crops and almonds.
The Produce Safety Regulation provides minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. Produce is subject to the Produce Safety Regulation unless it is “not covered” or is eligible for an exemption such as:
- Produce which is rarely consumed raw (RCR) (21 CFR 112.2(a)(1))
- Produced for personal or on-farm consumption (21 CFR 112.2(a)(2))
- Not a raw agricultural commodity (21 CFR 112.2(a)(3))
After publication of the Produce Safety Regulation, FDA received feedback from stakeholders that certain covered commodities (hops, wine grapes, pulse crops and almonds) should be exempt from the requirements of the Produce Safety Regulation as they are RCR. FDA reviewed how these commodities are grown, harvested, packed, held and used, and has decided to exercise enforcement discretion with respect to entities growing, harvesting, packing or holding these specific commodities.
For example, virtually all almonds in the U.S. are grown in California. Under the California Almond Federal Marketing Order (7 CFR Part 981) issued by the U.S. Department of Agriculture (USDA AMS), all almonds shipped from handlers to locations within the U.S., Canada or Mexico must undergo a treatment for the control of Salmonella such as blanching, roasting, steam treatment and treatment with propylene oxide. Consequently FDA decided enforcement discretion concerning this and other commodities was in order.
FDA is considering additional rulemaking to address requirements for these commodities and will not expect entities growing, harvesting, packing or holding these commodities to meet any of the Produce Safety Regulation requirements with respect to these commodities.
Verisk 3E Analysis
The FDA's intent to exercise enforcement discretion is effective on 28 March 2019. Growers of hops, wine grapes, pulse crops and almonds should be aware that the FDA's intent to exercise enforcement discretion concerning the requirements of the Produce Safety Rule will be revised if safety concerns arise concerning the production and consumption of these commodities.
Comments may be submitted any time either electronically or by mail to:
Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
All comments should bear the reference: Docket No. FDA– 2019–D–1266 for “Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds: Guidance for Industry.”