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Reopening of Public Comment Period for USDA’s Proposed Amendments to the National List of Allowed and Prohibited Substances under the Organic Foods Production Act

  • The public comment period for the United States Department of Agriculture (USDA) Agricultural Marketing Service’s (AMS) proposed rule describing 35 amendments to the National List of Allowed and Prohibited Substances (Crops, Livestock and Handling) was to have closed on March 19, 2018. On Friday, at the request of multiple stakeholders, USDA reopened the comment period for an additional 30 days. See 83 Fed. Reg. 16010 (April 13, 2018).

  • USDA’s proposed rule, published in 83 Fed. Reg. 2498 (January 17, 2018), would amend the National List of Allowed and Prohibited Substances (National List) provisions of USDA’s organic regulations to implement 29 recommendations submitted by the National Organic Standards Board (NOSB) on 35 amendments to the National List. The NOSB is authorized to assist in the evaluation of substances to be included on the National List in an advisory role. Many of the NOSB recommendations addressed in the proposed rule have been in USDA’s hands for several years. The recommendations were submitted on November 17, 2000, September 19, 2002, May 6, 2009, November 5, 2009, October 28, 2010, December 2, 2011, March 20, 2012, October 16, 2012, May 2, 2014, April 30, 2015, October 29, 2015, April 26, 2016, and November 18, 2016.

  • USDA’s rule proposes to change the use restrictions for seventeen substances currently allowed for organic production or handling: Micronutrients; chlorhexidine; parasiticides; fenbendazole; moxidectin; xylazine; lidocaine; procaine; methionine; excipients; alginic acid; flavors; carnauba wax; chlorine; cellulose; colors; and, glycerin.

  • The rule also proposes to add sixteen new substances to be allowed in organic production or handling: Hypochlorous acid; magnesium oxide; squid byproducts; activated charcoal; calcium borogluconate; calcium propionate; injectable vitamins, minerals, and electrolytes; kaolin pectin; mineral oil; propylene glycol; acidified sodium chlorite; zinc sulfate; potassium lactate; and, sodium lactate.

  • In addition, the proposed rule would list the botanical pesticide, rotenone, as a prohibited substance in organic crop production.

  • Finally, the proposed rule would remove ivermectin as an allowed parasiticide for use in organic livestock production.

  • The new deadline for commenting on USDA’s proposed amendments to the National List is May 14, 2018.

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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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