(Beyond Pesticides, December 12, 2022) It is time for the U.S. Department of Agriculture (USDA) to follow through on its duty to assess individual “inert” ingredients used in organic production. In creating the original regulations for the National Organic Program (NOP), USDA—based on the recommendation of the National Organic Standards Board (NOSB)—decided to postpone the evaluation of so-called “inert” ingredients until active materials had been reviewed for the National List of Allowed and Prohibited Substances. In this context, “inert” is a misleading legal term since the ingredient may be chemically or biologically active, but not included for purposes of attacking a target organism. The first regulation and all subsequent revisions have allowed the use of “inert” ingredients on EPA’s former Lists 4A (“minimal risk inert ingredients”) and 4B (“other ingredients for which EPA has sufficient information to reasonably conclude that the current use pattern in pesticide products will not adversely affect public health or the environment”). A limited number on List 3 (“inerts of unknown toxicity”) were allowed in pheromone products.
[This action requires a submission at Regulations.gov. You can copy and paste from the suggested comment below. Comments are due December 31, 2022.]
Tell USDA that the National Organic Program must evaluate “inert” ingredients used in organic production.
[Need help in submitting comments? Regulations.gov requires more than a single click, but it is not difficult. Please feel free to cut-and-paste language from the comments above into Regulations.gov and add or adjust the text to personalize it. See this instructional video. (Regulations.gov has changed its look since this video was made.)]
The Organic Foods Production Act (OFPA) requires that no synthetic substance may be used in organic production unless evaluated and recommended by the NOSB and entered on the National List, which is contained in NOP regulations. Now USDA is accepting comments on an advance notice of proposed rulemaking (ANPR) on “inert” ingredients used in organic production. The ANPR reflects a lack of understanding on the part of the USDA authors of the character of so-called “inert” ingredients and the requirements of the Organic Foods Production Act, as well as the history of efforts by the NOSB to address this issue. USDA refers to time, effort, and work required to implement the NOSB’s recommended reviews of individual “inert” ingredients. These references are disingenuous at best, considering the time that has elapsed since the issue became critical when the Environmental Protection Agency (EPA) announced that it was no longer supporting the lists to which NOP regulations refer—16 years ago.
Some crucial facts must be acknowledged by USDA:
* “Inert” ingredients are not biologically or chemically inert. The Beyond Pesticides report “’Inert’ Ingredients in Organic Production” compares the toxicity of active substances and “inert” substances used in organic production. In almost every category, there are more harmful “inerts” than active substances.
* OFPA allows the use of a synthetic substance in organic production only if it is listed on the National List “by specific use or application” based on a recommendation by the NOSB, following procedures in OFPA.
* The NOSB has repeatedly passed recommendations telling NOP to evaluate individual “inerts.”
In moving forward,
* There must be no more delay.
* The first step must be the immediate publication in the Federal Register of all “inerts” known to be used in organic production, with a request that registrants of products approved for use in organic production to notify AMS if their products contain other “inert” ingredients.
* USDA must allocate resources needed to review substances that are identified.
* Former List 3 “inerts” must be relisted according to the Spring 2012 NOSB recommendation.
* USDA must establish a process for production of technical reviews of substance on former Lists 4A and 4B.
* The NOSB must evaluate the substances according to a process designed to complete the review of all “inerts” within five years of publication of the list, and USDA must complete rulemaking in accordance with OFPA and NOSB recommendations.
* Known endocrine disrupting and persistent organic pollutants—such as nonylphenol ethoxylates (NPEs), per- and polyfluoroalkyl substances (PFAS), bisphenols, and orthophthalates—should not be permitted.
* Every five years the materials will be subject to sunset review.
This action requires a submission at Regulations.gov. You can copy and paste from the suggested comment below. Comments are due December 31, 2022.
Tell USDA that the National Organic Program must evaluate “inert” ingredients used in organic production.
[Need help in submitting comments? Regulations.gov requires more than a single click, but it is not difficult. Please feel free to cut-and-paste language from the comments above into Regulations.gov and add or adjust the text to personalize it. See this instructional video. (Regulations.gov has changed its look since this video was made.)]
Suggested comment:
It is time for the U.S. Department of Agriculture (USDA) to follow through on its duty to assess individual “inert” ingredients used in organic production. In creating the original regulations for the National Organic Program (NOP), USDA—based on the recommendation of the National Organic Standards Board (NOSB)—decided to postpone the evaluation of so-called “inert” ingredients until active materials had been reviewed for the National List of Allowed and Prohibited Substances. The first regulation and all subsequent revisions have allowed the use of “inert” ingredients on EPA Lists 4A (“minimal risk inert ingredients”) and 4B (“other ingredients for which EPA has sufficient information to reasonably conclude that the current use pattern in pesticide products will not adversely affect public health or the environment”). A limited number on List 3 (“inerts of unknown toxicity”) were allowed in pheromone products.
The Organic Foods Production Act (OFPA) requires that no synthetic substance may be used in organic production unless evaluated and recommended by the NOSB and entered on the National List, which is contained in NOP regulations. Now USDA is accepting comments on an advance notice of proposed rulemaking (ANPR) on “inert” ingredients used in organic production. The ANPR reflects a lack of understanding on the part of the USDA authors of the character of so-called “inert” ingredients and the requirements of the Organic Foods Production Act, as well as the history of efforts by the NOSB to address this issue. USDA refers to time, effort, and work required to implement the NOSB’s recommended reviews of individual “inert” ingredients. These references are disingenuous at best, considering the time that has elapsed since the issue became critical when the Environmental Protection Agency (EPA) announced that it was no longer supporting the lists to which NOP regulations refer—16 years ago.
Some crucial facts must be acknowledged by USDA:
* “Inert” ingredients are not biologically or chemically inert. The Beyond Pesticides report “’Inert’ Ingredients in Organic Production” compares the toxicity of active substances and “inert” substances used in organic production. In almost every category, there are more harmful “inerts” than active substances.
* OFPA allows the use of a synthetic substance in organic production only if it is listed on the National List “by specific use or application” based on a recommendation by the NOSB, following procedures in OFPA.
* The NOSB has repeatedly passed recommendations telling NOP to evaluate individual “inerts.”
In moving forward,
* There must be no more delay.
* The first step must be the immediate publication in the Federal Register of all “inerts” known to be used in organic production, with a request that registrants of products approved for use in organic production to notify AMS if their products contain other “inert” ingredients.
* USDA must allocate resources needed to review substances that are identified.
* Former List 3 “inerts” must be relisted according to the Spring 2012 NOSB recommendation.
* USDA must establish a process for production of technical reviews of substance on former Lists 4A and 4B.
* The NOSB must evaluate the substances according to a process designed to complete the review of all “inerts” within five years of publication of the list, and USDA must complete rulemaking in accordance with OFPA and NOSB recommendations.
* Known endocrine disrupting and persistent organic pollutants—such as nonylphenol ethoxylates (NPEs), per- and polyfluoroalkyl substances (PFAS), bisphenols, and orthophthalates—should not be permitted.
* Every five years the materials will be subject to sunset review.
Thank you for your consideration of this urgent issue.
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USDA Urged to Evaluate Undisclosed Inert Ingredients in Organic, as Required by Law - Beyond Pesticides
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