Making Sense of the National List

By Grace Gershuny


Every company working on formulating organic products, as well as their ingredient suppliers, must have a firm grasp of what substances can and cannot be used in producing those products and ingredients. Sometimes it is clear and straightforward—a product with an organic label on it must contain at least 95% by weight (excluding water and salt) certified organic agricultural products. Although the other 4.99% of that product does not have to be organic, it does have to comply with the U.S. Department of Agriculture’s (USDA) National Organic Program (NOP) regulations that comprise the National List (7 CFR 205.600-607). Non-organic ingredients may not be produced through genetic engineering, use sewage sludge as a fertilizer, or be irradiated. In addition, processing aids, such as defoamers and filtering agents used in producing the organic product, even if they don’t have to be listed on the label, must also comply with the National List.

The NOP has ruled that materials classified by the U.S. Food and Drug Administration (FDA) as “food contact substances,” which include boiler additives and sanitizers, do not need to be included on the National List before they can be used in producing organic products. Some of these, however, are now on the National List.

There are different rules for the non-organic portion of products labeled as “made with organic ingredients,” which only need to contain 70% organic ingredients, but this discussion will be confined to products labeled organic.

What is the National List?
The general purpose of the National List is to specify the exceptions to the general rule enshrined in the law, called the Organic Foods Production Act (OFPA), which prohibits the use of synthetic substances in organic production and allows the use of natural ones. It is thus a “negative” list, which avoids the problem of trying to list every natural material organic growers or processors might use. Many of the items listed include annotations that specify that these materials can only be used under certain conditions or in the production of certain products. The list is divided into six parts:

1. Synthetic substances allowed for use in organic crop production (Section 205.601) includes a total of 52 entries, some of which are classes of substances (e.g., EPA List 4—Inerts of Minimal Concern). Some examples are sticky traps, micronutrients and newspapers for mulch.

2. Nonsynthetic substances prohibited for use in organic crop production (Section 205.602) includes nine entries, some of which are annotated to be permitted under certain circumstances (e.g. “Chilean” nitrate). Examples include arsenic, tobacco dust, and ash from burning manure.

3. Synthetic substances allowed for use in organic livestock production (Section 205.603) has a total of 27 entries, including classes of substances such as vitamins and trace minerals. Some examples are aspirin, chlorine for disinfecting equipment and sanitizing facilities, and glycerin.

4. Nonsynthetic substances prohibited for use in organic livestock production (Section 205.604) includes only one substance, strychnine.

5. Nonagricultural (non-organic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic” (specified ingredients or food group[s]) (Section 205.605). This section of the regulations is further divided into 205.605(a) “Nonsynthetics allowed” and 205.605(b) “Synthetics allowed.”

Section 205.605(a) has 27 entries, including classes of substances such as acids and enzymes. Some examples of nonsynthetics allowed include dairy cultures, potassium chloride, camauba wax, and yeast.

Section 205.605(b) has 38 entries, many of which are ingredients in baking powder and sanitizers that are now considered “food contact substances.” Some examples of synthetics allowed include ascorbic acid (vitamin C), carbon dioxide, tocopherols (vitamin E) and xanthan gum.

In the wake of the Harvey v. Veneman lawsuit against USDA last year, there was considerable concern that organic processors would no longer be able to use substances listed on the allowed synthetics list (Section 205.605(b)) for products labeled as “organic.” The effects of this decision have now been reversed by legislative amendments supported by the Organic Trade Association (OTA). As a result of these amendments, the industry can breathe a sigh of relief. There is now no need to reformulate or relabel products made using any of the substances listed in Section 205.605(b).

6. Non-organically produced agricultural products allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group[s]).” (Section 205.606) This section lists non-organic ingredients that may be used if an organic version is not commercially available. The complete list currently includes: cornstarch (native), gums (water extracted only; arabic, guar, locust bean, carob bean), kelp for use only as a thickener and dietary supplement, unbleached lecithin, and high-methoxy pectin.

This list has generated some confusion, since different forms of pectin and lecithin are considered nonagricultural, and gums are specifically mentioned in the NOP definition as examples of nonagricultural ingredients.

Until the Harvey lawsuit, this section also allowed any non-organic ingredient to be used within the 5% allowance in an organic product if it is documented that the ingredient is not commercially available as organic. OTA’s legislative amendment did not address the part of the Harvey decision that requires any non-organic agricultural ingredient to be specifically listed here before it can be used. This is an important issue, which will be considered in more detail later.

Who Made These Rules?
The concept of the National List was developed from work done by OTA, including various organic producer and certification groups, prior to passage of the OFPA. Lists of allowed and prohibited substances collected from existing organic standards were found to be closely aligned with certain common criteria used to evaluate the acceptability of these substances. This work served as the basis for OFPA’s general prohibition on the use of any synthetic substance, and general allowance for the use of any natural substance in organic production and handling. It also established a clear basis for making exceptions to these general rules based on accepted organic practices that had broad consensus among producers.

Very few organic processors or manufacturers were involved in these discussions. While criteria for substances used in agriculture were well-defined in the OFPA, no similar criteria were provided for substances used in handling. There was also some ambiguity in the law about whether any synthetic substances could be used in handling an organic product.

During the public debates surrounding development of the NOP regulations, the consensus reached by the National Organic Standards Board (NOSB) was that some synthetic substances were essential to handling organic products, and could meet the evaluation criteria included in the OFPA. The NOSB also developed a set of evaluation criteria for synthetic substances allowed as processing aids and adjuvants that were incorporated into the National List regulations (Section 205.600[b]). These criteria state:

• The substance cannot be produced from a natural source and there are no organic substitutes.

• The substance’s manufacture, use, and disposal do not have adverse effects on the environment and are done in a manner compatible with organic handling.

• The nutritional quality of the food is maintained when the substance is used, and the substance itself or its breakdown products, do not have an adverse effect on human health as defined by applicable federal regulations.

• The substance’s primary use is not as a preservative or to recreate or improve flavors, colors, textures, or nutritive value lost during processing, except where the replacement of nutrients is required by law.

• The substance is listed as generally recognized as safe (GRAS) by FDA when used in accordance with FDA’s Good Manufacturing Practices (GMP) guidelines and contains no residues of heavy metals or of other contaminants in excess of tolerances set by FDA.

• The substance is essential for the handling of organically produced agricultural products.

Defining Terminology
One aspect of the National List that many find hard to understand is the terminology used to describe the various categories of substances. Why is “non-synthetic” used in place of “natural?” Why make the distinction between “agricultural” and “non-agricultural” ingredients? How do the definitions of these terms affect organic processors and producers?

The OFPA defines “synthetic,” but offers no definition for “natural.” In developing the regulations the NOP recognized that the most accurate way to characterize everything that is generally allowed in organic production and handling is to refer to it as “non-synthetic.” The NOSB has recently been working to help clarify the definition of “synthetic,” since many substances that appear on the Allowed Synthetics list (Section 205.605(b)) of the National List are derived from naturally occurring substances, such as calcium hydroxide from limestone, and do exist in nature, such as ascorbic acid. This work is still in progress, and OTA’s task force on materials has developed a position paper that addresses the subject.

The OFPA does not address nonagricultural substances used in processing but does talk about ingredients that are not organically produced. The NOP therefore contains a definition of “nonagricultural” that includes isolates or fractions of agricultural products that are no longer identifiable in the isolate or fraction. The NOP includes examples such as gums, citric acid and pectin.

While the intent is to encourage the use of organic minor ingredients to the extent possible, some ingredients could never be available in organic form, since they are not agricultural products. However, this distinction too has become problematic as manufacturers have begun to produce such certified organic products as yeast and alcohol. Yeast is currently categorized as a nonagricultural product because it is grown in vats not fields, but it is a living organism that is being cultivated, in a manner of speaking. As it stands, bakers are not obligated to use the organic form of the yeast, even if it is commercially available. OTA’s materials task force has also weighed in to suggest clarifying the definition of “nonagricultural” to eliminate living organisms that could potentially be organically produced.

Room for Improvement
The OFPA recognizes that the National List must be fluid and so provides a process for adding substances that ensures all changes receive extensive public scrutiny. It also includes the presumption that those substances that are on the National List should not stay there indefinitely if they no longer meet the criteria. This is referred to as a “sunset review” requirement, which must be conducted within five years of adding a substance to the National List. This process is now under way for the substances on the original National List, which went into effect in October of 2002.

The process of adding a substance to the National List begins with a petition submitted to the NOSB. The petition must contain enough information about the substance to show that it meets the criteria outlined in the OFPA and the regulations. The NOSB then reviews the petition and, if it looks like all the required information is there, sends it to a technical advisory panel (TAP) for scientific evaluation. The NOSB then must recommend, based on the TAP review and public comment, to add the substance to the National List by a two-thirds majority vote.

This recommendation goes to the NOP, which must publish the proposed addition in the Federal Register for public comment. The substance is added to the National List and can be used in organic production or handling only after it is published in the Federal Register as a final rule. This whole process takes at least a year, and sometimes longer.

A petition can also be used to request that a substance be removed from the National List, and must provide evidence showing that the substance no longer meets the requisite criteria. Petitions can also be used to request changes to annotations and to the category under which the substance is listed (e.g., change from nonagricultural to agricultural).

It is important to note that there are differences between petitioning for a change in the National List and the sunset review requirements. Substances that are on the National List will be automatically removed if they have not been reviewed and approved by the NOSB and published in the Federal Register once five years have elapsed. All changes require a Federal Register notice and opportunity for public comment before becoming final.

The National List and You
Thanks to the effort organized by the OTA to encourage members to submit comments in response to the June 2005 Federal Register notice concerning sunset review, most of the substances currently on the National List have received such comments.

The NOSB handling committee recommended that some materials, such as colors and flavors under 605(a), and ethylene under 605(b), are deferred until further technical information is obtained. They also recommended removal of potassium tartrate made from tartaric acid, which was found to duplicate the listing of potassium acid tartrate.

At its November 2005 meeting, the NOSB voted to approve these recommendations. Those that were deferred will be voted on at the Spring NOSB meeting. Otherwise, the NOSB voted to approve all the materials that currently appear on the National List for continuation.

A similar effort is now under way to ensure that the list of non-organic agricultural ingredients allowed (Section 205.606) reflects the current and anticipated need for non-organic minor ingredients. OTA’s 606 Task Force is working on developing a position paper and recommendations for the NOSB concerning what criteria should be used to add materials to this part of the list, and how the list should be organized. For example, should “herbs and spices” be an item on the list, or will each specific herb and variety of herb have to appear on the National List. Can it be just “oregano,” or should it specify “oregano, Greek, with minimum X% essential oil content”?

The organic community can help in this critically important process by completing the OTA members survey about 606 issues at the OTA Members Only section of the Website by clicking on “polls.” OTA has also developed a suggested template for members to use when they are preparing petitions for adding agricultural substances to the National List.

Remember that after June 2006 any non-organic agricultural product that does not appear on Section 205.606 will no longer be permitted for use as an ingredient in a product labeled “organic,” even if it is not commercially available as organic. However, even if it does appear on this list, you must still document the lack of commercial availability of an organic form before you can use it.

If you use anything that appears on the National List in producing organic products you should stay informed about any changes to the rules, and especially any changes in what substances appear on the National List. The most direct source of this information is the USDA National Organic Program (www.ams.usda.gov/nop). OTA members will also receive regular updates and information about the National List, along with suggestions for action that you can take.

Grace Gershuny is an organic consultant with GAIA Services. Her clients include the Organic Trade Association. Gershuny can be reached at graceg@kingcon.com.