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FDA Issues Compliance Guide for Small Businesses under FSMA Produce Safety Rule

  • FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here.
  • On September 5, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) to help small businesses comply with the Produce Safety Rule mandated by FSMA. In particular, the SECG is designed to help farmers determine whether they are eligible for a qualified exemption, which would modify the requirements they are subject to under the Produce Safety Rule.
  • The main compliance dates for small businesses and very small businesses under the Produce Safety Rule are January 28, 2019, and January 27, 2020, respectively, but certain agricultural water requirements have extended compliance dates (see previous blog coverage here). Sprout operations also have different compliance dates, and sprout operations that are small businesses and very small businesses have compliance dates of January 26, 2018, and January 28, 2019, respectively. Businesses that intend to claim a qualified exemption by their primary compliance date were required to begin keeping documentation supporting their eligibility for a qualified exemption on January 26, 2016.
© 2020 Keller and Heckman LLPNational Law Review, Volume VII, Number 250
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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