On August 23, the Agricultural Marketing Service (“AMS”), an agency housed within the United States Department of Agriculture (“USDA”), published a proposed rule to amend the National List of Allowed and Prohibited Substances (“National List”) and remove four substances currently allowed in organic agricultural production and 14 nonorganic ingredients currently allowed in organic foods. This process, known as “sunset review”, takes place frequently and is AMS’s way of ensuring consistent organic standards. AMS is seeking comments on this proposed rule, and will consider those comments when drafting the final rule. Comments are due Monday, October 25, 2021.

Background

In 1990, Congress passed the Organic Foods Production Act (“OFPA”). The OFPA was enacted in part “to assure consumers that organically produced products meet a consistent standard”. 7 U.S.C. § 6501(2). A decade later, on December 21, 2000, AMS published a final rule creating the National Organic Program (“NOP”). At the inception of the NOP, AMS published the National List for organic production and handling. The National List indicates which synthetic substances organic producers and processors are allowed to use, and which natural (or non-synthetic) substances organic producers and processors are not allowed to use. Additionally, the National List provides which non-organic substances, or ingredients, may be used in or on organic foods. The National List helps further the OFPA purpose of assuring consumers that all organic products meet a consistent standard.

The National List was first created in 2000. Since then, substances have been added and taken off either through petitions or through the sunset review process. Although AMS has the ultimate say as to whether a substance is added or removed from the National List, the process starts with the National Organic Standards Board (“NOSB”), a 15-member Federal Advisory Committee. Anyone can send the NOSB a petition to add or remove a substance from the National List. The NOSB evaluates petitions during its public meetings, which take place about twice a year, and will recommend AMS either amend the National List as the petition asks, or to leave the National List as is.

In addition to petitions, the NOSB also reviews the substances on the National List. Substances are up for review every five years, and the deadline by which the NOSB must review a substance by is called the “sunset date”. When a substance’s sunset date is approaching, the NOSB evaluates the substance against required criteria. These criteria include the substance’s impact on human health and the environment, its necessity due to the unavailability of natural versions or natural alternative substances, and its consistency with organic production and handling. If the NOSB determines a substance meets the required criteria, then the NOSB will publish a notice on the Federal Register announcing the substance will stay on the List for at least another five years.

If the NOSB determines that a substance does not meet the required criteria, it will hold a vote on whether to remove the substance. The NOSB will recommend removal if two-thirds of the NOSB votes in favor of removal. The NOSB will then send its removal recommendations to AMS. AMS will then decide whether to accept or reject the NOSB’s removal recommendations. If AMS accepts the NOSB’s removal recommendations, it will publish a purposed rule in the federal register seeking comments on whether to remove the substance in question.

Proposed rule

On August 23, AMS published a proposed rule asking for comments on whether it should amend the National List to remove certain substances as recommended by the NOSB. All substances in question have a sunset date in 2022. AMS proposes to remove four synthetic substances, and 14 non-organic substances. If removed from the National List, organic producers and processors will not be authorized to use these substances after their sunset dates.

The following are the synthetic substances AMS proposes to remove:

• Sucrose Octanoate Esters (insecticide in crop production and miticide in honeybee production)
• Vitamin B₁ (plant and soil amendment in crop production)
• Procaine (local anesthetic in livestock production)
• Oxytocin (post parturition therapeutic applications in livestock production)

For Sucrose Octanoate Esters, Vitamin B₁, and Procaine, the NOSB found that there are non-synthetic, or more natural, alternatives and that these substances are not widely used. In particular, for Procaine, AMS found that that all approved animal drugs containing Procaine also contain antibiotics, rendering all approved drugs containing Procaine in violation of the required criteria. As for Oxytocin, AMS is seeking more information on what specific alternatives are available because the NOSB in its recommendation for removal only stated alternatives existed, but did not specify what those alternatives are.

Additionally, AMS is proposing to remove the following substances which are currently allowed in their non-organic forms as ingredients in organic foods:

• Alginic acid (food stabilizer and thickener)
• The following food colors:
  • Black current juice color
  • Blueberry juice color
  • Carrot juice color
  • Cherry juice color
  • Grape juice color
  • Paprika color
  • Pumpkin juice color
  • Turmeric extract color
• Kelp (food thickener and dietary supplement)
• Konjac flour (food starch and gelatin alternative)
• Sweet potato starch
• Turkish bay leaves
• Whey protein concentrate

All of these substances are currently allowed in organic production only when an organic version is not commercially available. For all proposed removals, except for the food colors, AMS found that there are organic versions commercially available and there are very few, if any, operations using the ingredients in the non-organic form. To determine that there are commercially available alternatives AMS searched the Organic Integrity Database. For Konjac Flour, for example, AMS found 30 operations selling certified organic Konjac products. As for the food colors, AMS is seeking more information on whether there are sufficient amounts of the organic versions to meet demand.

Additionally, AMS is seeking comments about whether organic producers, processors, and handlers require time to comply with the proposed removals, and if so, how much time after the sunset date is necessary to comply with the proposed changes.

What’s to come

After the comment period closes on Monday, October 25, 2021, AMS will read the comments and take them into consideration when drafting a final rule. Depending on comments received in response to the proposed rule, AMS may decide some of the substances should remain on the National List for at least the next five years. Thus, the final rule may mirror the proposed rule, or AMS may de-list only some of the 18 substances. Once the final rule is in effect, organic producers, processors, and handlers will not be authorized to use the de-listed substances and maintain the ability to label their products as USDA certified organic.

To read the proposed rule in full and submit a comment, click here.

To look up a sunset date for a particular substance, click here.

For more information on the NOP’s Sunset Review Process, click here.

For more Center resources on the National Organic Program visit the National Organic Program Reading Room, here.

To read “A Legal Guide to the National Organic Program”, a National Agricultural Law Center resource, click here.

**This article was written by former NALC Staff Attorney Jana Caracciolo.