On May 15, 2007, the U.S Department of Agriculture (“USDA”) issued a proposed rule to amend the agency’s National Organic Program (“NOP”) regulations at 7 C.F.R. Part 205. The proposal, if finalized, would add 38 ingredients to the National List of Allowed and Prohibited Substances (“National List”) at § 205.606 of the NOP regulations.
The NOP develops the federal regulatory framework governing organic food, and covers all agricultural products, including crops and livestock, and fresh and processed food. Under the NOP regulations, farmers and food processors must be certified in order to use the word “organic” in reference to their businesses and products. A finished food product qualifies for an organic seal if at least 95% of the product is organic and the remaining non-organic substances appear on the National List as permitted substances. A finished product may bear a label stating “made with organic” if at least 70% of the product is organic and the remaining non-organic substances appear on the National List.
In January 2005, the U.S. Court of Appeals for the First Circuit ruled in Harvey v. Veneman that an interpretation that the NOP regulations at 7 C.F.R § 205.606 create a blanket exemption from the National List was contrary to the Organic Foods Production Act of 1990, which authorized the establishment of the NOP regulations. On remand, the U.S. District Court of Maine ruled in Harvey v. Johanns that § 205.606 was unclear and had been misinterpreted to permit the use of any non-organic agricultural product in “certified organic” or “made with organic” products as long as an accredited certifying agent determined that an organic version of the product was not commercially available. To prevent future misinterpretation, the court ordered the USDA to clarify that any non-organic agricultural product may be used in organic and made with organic food products only if that product is included on the National List as a permitted substance. The court allowed the continued sale of products “produced in conformance with the misinterpretation” until June 9, 2007. Subsequently, the USDA issued a final rule clarifying § 205.606 (effective June 9, 2007) so that a non-organic agricultural product may only be used when the product is listed in § 205.606 and an accredited certifying agent determines that an organic form of the product is not commercially available. Consequently, as of June 9, 2007, the use of any non-organic agricultural substance that is not included in § 205.606 is prohibited. The use of a product is not permitted until the USDA publishes a final NOP regulation amending the National List to include the substance. To prevent the disruption of organic commerce, the USDA/NOP allows only seven days to comment on a proposed amendment to the National List.
Any interested person may send a petition to the NOP to add a substance to the National List. The National Organic Standards Board (“NOSB”) reviews each petition. At least 30 days before a public hearing by the NOSB, the petition is made available to the public for comment. During the NOSB meeting, any interested person has an opportunity to publicly comment on the petition. Based on the petition, oral and written comments, and discussion, the NOSB votes on whether to recommend the addition of a petitioned ingredient to the National List. Therefore, interested parties have an opportunity to comment on proposed additions to the National List long before a proposal to amend the National List is published in the Federal Register.
The 38 substances that the USDA/NOP proposes to add to the National List at § 205.606 include 19 colors, fish oil, fructooligosaccharides, gelatin, oligofructose-enriched inulin, pectin, chipotle chili pepper, unmodified rice starch, and whey protein concentrate. The deadline for written comments is May 22, 2007. Inclusion on the National List does not mean that the product can be used. Annually, a certifying agent must evaluate whether an organic alternative is commercially available.
- Congressional Research Service Report on Harvey v. Veneman