USDA Changes Organic Ingredient Rules

WASHINGTON - Apr 28/10 - SNS -- The USDA said it is correcting a 2006 decision by the National Organic Program (NOP) regarding "accessory nutrients" in organic processed food based on new information from the Food and Drug Administration (FDA).

"Consumers have the right to the best information about what is included in products carrying USDA's Organic seal, and producers need clearly defined standards and processes in order to ensure that they can meet regulatory requirements and satisfy market demand for organic food," said Miles V. McEvoy, deputy administrator of the National Organic Program. "Today's announcement will strengthen the National Organic Program by providing greater confidence for consumers and better information and procedures for producers."

In 2006, the NOP issued a decision in response to a complaint regarding fortification of infant formula with DHA, ARA and other substances that are not on the National List of Allowed and Prohibited Substances. Established under the Organic Foods Production Act of 1990, the National List of Allowed and Prohibited Substances identifies synthetic substances that may be used, and the nonsynthetic substances that cannot be used, in organic production and handling operations. The NOP's understanding at the time of the decision was that the substances were allowed as "accessory nutrients" under the National List § 205.605(b) Nutrient Vitamins and Minerals, in accordance with 21 CFR 104.20, Nutritional Guidelines for Foods and the National Organic Standards Board Recommendations.

After recent consultation with the FDA, it was determined that this is an incorrect interpretation of 21 CFR 104.20, Nutritional Guidelines for Foods. The NOP plans to publish draft guidance later this year that will align with the FDA interpretation of the Nutritional Guidelines for Foods. The draft guidance will provide a transition time for businesses to reformulate products to comply with the regulations as per the FDA guidelines. There will be a 60-day comment period for the draft guidance. Final guidance will be published after all comments have been reviewed.

All policy decisions will be made through the Federal Register and in compliance with Executive Order 12866. Transparency is a core principle for the NOP and USDA, and a commitment to a public process.

The NOP is also requesting that the National Organic Standards Board reevaluate its recommendation for nutrient vitamins and minerals during the 2012 sunset process, and provide specific recommendations regarding the scope of permitted vitamins, mineral and nutrients in organic food products.

Any company or interest group may petition to add substances to the National List during this transition period.