January 15, 2021

Volume XI, Number 15

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USDA’s Proposed Rule Strengthens the Enforcement and Oversight of Organics

  • On July 9, 2020, USDA’s Agricultural Marketing Service unveiled an unpublished draft of Strengthening Organic Enforcement, which is a new rule for the National Organic Program aimed at bolstering enforcement and oversight of the US organic industry.  This proposal addresses challenges by making changes in four major areas.

  • First, the proposed rules limit the types of businesses that are exempt from organic certification, which closes gaps in oversight that increase the risk of fraud and mishandling that can compromise organic products.   This proposed rule applies to those businesses that “buy, sell or trade organics, or businesses that negotiate the purchase, sale or trade of organic products between buyers and sellers.”

  • Second, the proposed rule mandates electronic National Organic Program import certificates for all organic products.  This represents a change from the current system, which only requires import certificates from certain countries, like those in the EU, South Korea, and Japan.  The director of AMS’ Standards Division noted that requiring electronic National Organic Program Import Certificates for each shipment of organic products into the US will help ensure compliance of imported organics by “providing traceability to the port of entry and creating an auditable record trail.”

  • Third, the proposed rule includes standardized record-keeping requirements, which are meant to help prevent and quickly contain fraud at the operation level before it continues onto the supply chain.

  • Lastly, the new proposal requires that certifiers take additional steps to protect the integrity of the organic supply chain and addresses on-site audits.  For example, the proposed rule requires that all certifiers conduct unannounced inspections of at least 5% of the operations they certify annually.  We will continue to monitor any developments.

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© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 198
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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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