National List Criteria: Inside the review process

Organic regulations require certified operations to demonstrate they are promoting ecological balance, conserving biodiversity, managing livestock to meet health and wellness requirements and using only approved farming and handling inputs. Organic agriculture is also governed by the basic rule that natural and organic inputs are allowed while synthetic inputs are prohibited. In some cases, however, synthetic or non-organic inputs are the only option available because of the absence of a natural or organic alternative. The National List of Allowed and Prohibited Substances (National List)—a component of the organic standards—was created to accommodate these exceptions.

Supported by three-legged stool

A primary function and responsibility of the National Organic Standards Board (NOSB) is to determine the suitability of inputs that may be used in organic farming and handling. The evaluation criteria and review process used by NOSB can be likened to a three-legged stool. The National List, often referred to as the “Restricted Organic Toolbox,” is supported by three legs, each one representing criteria to be met for an input to be added or removed from the National List. If any one of the three legs is missing, the stool falls over.

The organic law and organic regulations include a number of factors NOSB must consider when deciding on allowing an input. The conditions that must be met fall into three main criteria: 1) the input is necessary or essential because of the unavailability of natural or organic alternatives, 2) the input is not harmful to human health or the environment, and 3) the input is suitable or compatible with organic farming and handling. These three comprise the three legs of the stool.


Perhaps the most simple of the three main criteria is researching whether there are natural or organic alternatives. The organic law clearly states the National List may allow the use of an input in organic farming or handling if it is “necessary to the production or handling of the agricultural product because of the unavailability of wholly natural substitute products.” The law also states NOSB shall consider alternative practices or other available materials.

While this leg of the stool is arguably the simplest of the three, NOSB and organic stakeholders have long struggled with the criteria. How much of something is needed to consider it available in the volume needed? What if a natural alternative is available but the quality is insufficient? What if the alternative works in one region of the country but not another? Determining whether there are natural or organic alternatives continues to be more challenging than one might think. For this, NOSB relies heavily on feedback from organic stakeholders.

Health and the environment

The restricted organic toolbox represents the best and least toxic technology our food system has developed. This principle is bound by the organic law, which states inputs that otherwise would be prohibited can be added to the National List only if their use is not harmful to human health or the environment. The law also requires the final decision made by USDA be done so in consultation with the Secretary of Health and Human Services and the Administrator of the Environmental Protection Agency.

The organic law provides NOSB with evaluation criteria to consider and explore the toxicity of the input during manufacture, use and disposal, and the potential interactions it may have with other inputs or within the farming ecosystem. The organic regulations bring in additional but similar criteria for synthetic processing aids and adjuvants that consider the impact their use has on the environment and the safety status under the Food and Drug Administration (FDA).

Evaluating whether an input may be harmful to human health and the environment is no easy task. It is for this reason NOSB may request the assistance of a third party—a Technical Review—to evaluate a material.

Suitability with organic practices

NOSB must also determine the suitability of an input with organic practices. This is arguably the most nebulous of the three criteria, prompting NOSB to pass a guidance recommendation in 2004 that includes a series of questions to assist the Board in its evaluation process.

Guidance questions are largely tied to the regulatory definition of “organic production” emphasizing practices that foster cycling of resources, promote ecological balance and conserve biodiversity. Questions also ask about the influence the input may have on animal welfare, consistency the input has with items already on the National List and with international standards, and whether the input satisfies the expectations of organic consumers regarding the authenticity and integrity of organic products.

The third leg can be viewed as the “equalizing” leg of the stool, helping NOSB balance its evaluation of alternatives, human health and the environment. For example, if the information provided on human health raises some concerns, but the science is insufficient, or alternatives are available but they do not work in all regions of the country or in all types of products, NOSB will evaluate how suitable the input is overall with the foundations of organic production and handling.

Depending on engaged stakeholders

The three-legged stool holding up the National List stands on a firm foundation made up of organic stakeholders, the organic law, the organic regulations, NOSB and USDA’s National Organic Program.  The organic law was created in response to the needs of organic stakeholders, and the law created NOSB and the USDA organic regulations. Today, the entire process used to shape the National List continues to be powered and driven by stakeholders throughout the supply chain and organic community. The National List criteria are tough, the process is rigorous, the discussion and decisions are thoughtful and transparent. NOSB depends on an active engaged stakeholder community weighing in to provide information to keep the three-legged stool balanced and strong enough to ensure confidence and integrity in our organic products.  //