Formal Recommendation by the 

National Organic Standards Board (NOSB) 

to the National Organic Program (NOP)

 

Date: April 29, 2011

Subject: Classification of Materials 

Chair: Tracy Miedema 

 

 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action 

Guidance Statement 

Other x 

 

Statement of the Recommendation (Including Recount of Vote): 

 

The Materials committee provided an update and proposed guidance to 

continue the work of the National Organic Standards Board on classification of 

materials. The document included an update on the committee’s work on 

classification and two action items related to classification of materials. 

The first action item was a motion to rescind the April 2010 NOSB 

recommendation adding a second sentence to the definition of chemical 

change. This second sentence was added to address public comment 

received at the November 2009 NOSB meeting saying that the definition of 

chemical change, as recommended by the NOSB at that meeting, was too 

broad. Since the April 2010 meeting it has become clear to the committee that 

the public comment could be addressed through the guidance document being 

developed and did not need the additional sentence added to the definition of 

chemical change. Therefore the committee recommended rescinding the 

second sentence. Public comment received at the April 2011 meeting 

uniformly supported rescinding the second sentence. The NOSB voted 14 yes 

and 0 no in favor of the motion to rescind the April 2010 NOSB 

recommendation adding a second sentence to the definition of chemical 

change. 

The second action item in the Materials committee document was proposed 

guidance that a significant level of a synthetic substance in the final material 

means a level exceeding any applicable regulatory limits, where in effect for the 

material being classified, and a level without any technical and functional 

effects in the final material. Providing clarity to how to approach what is a 

significant level of a synthetic substance remaining in a final material being 
classified has been a consistent request of public comment during the time 

NOSB has been working on classification. The guidance proposed by the 

Materials Committee received mixed public comment. Public comment was 

unified that the classification work needs to be completed since it is 

foundational to so many board decisions. 

Key points of the NOSB discussion on the second action item were: 

 What are technical and functional effects? How are they different? 

 Is it ‘a level exceeding applicable regulatory limits AND a level without 

technical/functional effects’? Should it be ‘OR a level without 

technical/functional effects’? 

 What are the implications to current classification of materials with this 

guidance? 

 Examples of how the proposed guidance would be used in practice were 

needed to clarify for the board its application 

The Materials Committee asked that the board vote on the proposed guidance, 

despite the questions, so that the committee could proceed with the guidance 

document on classification with an understanding of the perspective of the full 

board on this important topic. The motion was to accept the proposed 

guidance that a significant level of a synthetic substance in the final material 

means a level exceeding any applicable regulatory limits, where in effect for the 

material being classified, and a level without any technical and functional 

effects in the final material. This motion was made by Katrina Heinze and 

seconded by Steve DeMuri. The vote was 8 yes and 6 no. Since the vote was 

not decisive, the motion failed and the proposed guidance was sent back to the 

Materials Committee for further refinement. 

 

Rationale Supporting Recommendation (including consistency with 

OFPA and NOP): 

 

 See accompanying recommendation 

 

Committee Vote: 

Moved: Katrina Heinze Second: Tina Ellor 

Yes: 8 No: 6 Abstain: 0 Absent: 0 Recusal: 0 
National Organic Standards Board 

Materials Committee 

Update and Proposed Guidance Document 

Classification of Materials 

April 29, 2011 

At the November 2009 National Organic Standards Board (NOSB) meeting, the NOSB passed 

a recommendation on Classification of Materials. The recommendation included several “Next 

Steps,” that the NOSB felt were required in order for the recommendation to be implemented. 

The primary further work required of the NOSB was development of a Guidance Document 

that the various stakeholders (e.g., Accredited Certifying Agents, committees of the NOSB, 

National Organic Program personnel) could use when classifying materials. 

At the April 2010 NOSB meeting, the Joint Materials and Handling Committee presented a 

draft Guidance Document for public input. It was clear from that public input that the guidance 

document needed more work. Key points from public comment were: 

 The draft guidance document accurately reflected the November 2009 NOSB 

recommendation 

 Separate guidance documents for crops, livestock and handling inputs are needed 

 Examples of crops and livestock material and how they would be evaluated need to be 

included 

 Agreement with the committee that further clarification was needed in determining 

whether materials contain a “significant” amount of a synthetic input in the final material. 

At the same April 2010 NOSB meeting, the NOSB passed an addendum to the definition of 

chemical change that the NOSB had recommended at the November 2009 NOSB meeting. 

In September 2010, the National Organic Program (NOP) responded to the NOSB 

recommendations of November 2009 and April 2010. In general, the NOP’s comments aligned 

with those received in public comment at the April 2010 meeting. Additionally, the NOP did not 

support the addendum to the definition of chemical change. 

The Materials Committee has been working in response to these comments to develop a final 

proposed guidance document. Unfortunately, we have not made as much progress as we 

would have liked and do not have a complete proposed guidance document available for 

public review and comment at this time. Key topics that we have discussed have been the 

format of a guidance document, clarification of significant level of synthetic input remaining in a 

material, definition of chemical change and scope of classification. The purpose of this 

document is to provide an update to the full NOSB, the NOP and the public. 

Proposed Action -- Definition of Chemical Change 

The definition of chemical change approved by the NOSB in November 2009 is: 

Chemical Change An occurrence whereby the identity of a substance is modified, such 

that the resulting substance possesses a different distinct identity (see related definition 

of “substance”) 
Update and Proposed Guidance Document 

Classification of Materials 

April 29, 2011

Page 2 of 5

The April 2010 addendum approved by the NOSB is (shown as the underlined sentence): 

Chemical Change An occurrence whereby the identity of a substance is modified, such 

that the resulting substance possesses a different distinct identity (see related definition 

of “substance”). Processing, as defined in §205.2, of agricultural products using 

materials allowed on the applicable section of the National List (i.e., §205.601 for crops, 

§205.603 for livestock and §205.605 / §205.606 for handling), does not result in 

chemical change as it applies to classification of materials. 

We appreciate the NOP’s perspective on this second sentence. This recommended 

second sentence was the focus of much public comment at the April 2010 NOSB meeting 

and was edited several times by the committee during the meeting in response to public 

comment. After reviewing the topic and the original intent of the addendum, the Materials 

Committee is recommending that the NOSB rescind their April 2010 recommendation 

adding the second sentence to the definition of chemical change. We believe that we can 

address the concerns that prompted the addition of the second sentence, discussed below, 

through a guidance document. 

The intent of the addendum was to address “whether chemical changes generated during 

processing methods specifically allowed in the Organic Foods Production Act (OFPA) 

and/or allowed National List materials, would render an otherwise agricultural product 

“synthetic.” Public comment received at the November 2009 meeting showed a consistent 

concern that the recommended definition of chemical change, and its associated definition 

for substance, went too far and would result in a number of agricultural materials being 

classified as synthetic. A simple example to illustrate this point is toasted wheat kernels. 

Wheat kernels are clearly agricultural. When exposed to heat, the kernels toast resulting in 

chemical change. Public comment clearly indicated that classifying something like a 

toasted wheat kernel as synthetic was not the intent of OFPA. 

The Materials committee agrees and will work with the original November 2009 NOSB 

recommended definition of chemical change within our guidance document to show that 

chemical changes generated during processing methods allowed in OFPA or with National 

List materials, where appropriate, do not result in a material being classified as synthetic. 

Proposed Guidance -- Significant Amount/Level of Synthetic Input Remaining in the 

Material to be Classified 

A key topic left unresolved in the April 2010 Draft Guidance Document was the question, 

“What is a significant amount/level of a synthetic input to the process remaining in the final 

material?” The Materials Committee spent the majority of our time on this topic evaluating 

two different approaches. 

One approach we considered would be evaluate any known level of a synthetic substance 

in the final material or in the environment, as a result of the substance’s manufacture, use 

and disposal would be a significant level. In March 2006, in a response to NOSB, the 

National Organic Program wrote, “One of the primary determinants of whether a food can 

be considered ‘organic’ is whether it contains or was produced with ‘synthetic’ substances.” 
Update and Proposed Guidance Document 

Classification of Materials 

April 29, 2011

Page 3 of 5

Proponents of this approach suggest that consumer trust is paramount for long-term 

organic viability, requiring an assurance that organically labeled products meet a consistent 

standard in compliance with the OFPA statutory standard on synthetic agents and their 

allowance. OFPA states, “The National List may provide for the use of substances in an 

organic farming or handling operation that are otherwise prohibited under this title only if (A) 

the Secretary determines, in consultation with the Secretary of Health and Human Services 

and the Administrator of the Environmental Protection Agency, that the use of such 

substances (i) would not be harmful to human health or the environment...” (Sec. 2118 [7 

U.S.C. 6517]). While the law does not envision the use of purposefully added synthetic 

materials not on the National List, the list provides the mechanism for evaluating harm. 

This statutory intent is captured in the “Evaluation Criteria for Substances Added to the 

National List” with the questions, “Is there any harmful effect on human health? [§6517 c 

(1)(A) (i) ; 6517 c(2)(A)I; §6518 m.4]?” and, “Is the substance harmful to the environment 

and biodiversity? [§6517c(1)(A)(i);6517(c)(2)(A)i]?” Proponents believe this standard of 

review requires a determination as to whether there is harm associated with the use of the 

synthetic substance, and therefore subject to the National List review process. Under this 

approach, all synthetic inputs or residues must be examined to determine their associated 

health and environmental impacts. 

The second approach we considered, and which ultimately received the support of the 

majority of the committee, was that a significant level of a synthetic substance in the final 

material means a level exceeding any applicable regulatory limits, where in effect for the 

material being classified, and a level without any technical and functional effects in the final 

material. Proponents of this approach believe this approach is more consistent with past 

NOSB practice and precedent, is consistent with the recommendation of the Material 

Working Group and reflects the bulk of the public comment we’ve received on this topic. 

Additionally, the majority of the Materials Committee was concerned with using an 

approach of “any known level” knowing that technology allows the detection of ever 

decreasing amounts of material. So a material that today has no known level of synthetic 

input in it may very well tomorrow have a detectable level. The majority of the committee 

felt that using the “any known level” approach would be disruptive to the industry as it 

differs from past practice and precedent and would lead to an on-going reevaluation of 

materials on a perpetual basis as detection levels change. As we discussed this approach, 

we acknowledge that a given material may not have any applicable regulatory limits or may 

have several. In the case where no regulatory limit is available, technical and functional 

effects of any remaining synthetic would need to be evaluated. In the case where, multiple 

regulatory limits exist, the reviewer should evaluate which best applies for the classification. 

For example, for a synthetic solvent used to extract a natural sourced material there may 

exist an OSHA inhalation limit and EPA tolerance level for an inert. Since the synthetic is 

present in a material to be used in crops, the EPA limit is most appropriate. 

As a result of our discussions, the Materials committee recommends that the NOSB adopt 

as guidance that a significant level of a synthetic substance in the final material means a 

level exceeding any applicable regulatory limits, where in effect for the material being 

classified, and a level without any technical and functional effects in the final material. This 

guidance is intended to apply only in cases where a synthetic input is removed from the 
Update and Proposed Guidance Document 

Classification of Materials 

April 29, 2011

Page 4 of 5

final material with the intention of fully removing the synthetic input but complete removal is 

not possible. For example, extraction of a natural with a synthetic solvent. 

Update -- Scope of Classification 

The Materials Committee spent a considerable amount of time discussing the scope of 

classification and whether it should include evaluation of whether a material is allowed or 

prohibited for use in organic production or handling. Consistent with all past NOSB thinking 

on this topic, we concur that classification of a material is a separate evaluation step for a 

material from the evaluation of whether use of the material is consistent with organic 

practices. 

While our conclusion may seem self-evident, we affirm that this is a critical topic for all 

boards to discuss and understand. As an example of the criticality of this distinction, a 

material, manufactured with a synthetic, may be classified as non-synthetic. However, the 

NOSB has a further obligation to determine whether use of that material is consistent with 

organic practices. In their review for classification, a NOSB committee may determine that 

while non-synthetic the material should be prohibited for use in organic production. 

Similarly, an ACA or Material Evaluation Programs may when reviewing a material 

determine that it is non-synthetic but during review of the manufacturing process develop 

concerns about its compatibility with organic practices. We believe that all stakeholders in 

the organic industry have an obligation to bring that information to the attention of the 

NOSB so that the NOSB can meet our statutory responsibility to review materials to 

determine if their use in organic production and handling is compatible with organic 

practices. 

References 

National Organic Standards Board Recommendations & other documents: 

 Materials and Handling Committee, “Classification of Materials,” May 24, 2010 

 Materials and Handling Committee, “Classification of Materials,” November 6, 2009 

 Materials and Handling Committees, “Discussion Document on the Definition of 

Materials,” October 19, 2007 

 Handling Committee and Materials Committee, “Recommendations Relative to 

“Agricultural” and “Nonagricultural” Substances for National List Consideration,” 

September 15, 2006 

 Handling Committee, “Recommendations Relative to “Agricultural” and 

“Nonagricultural” Substances,” July 14, 2005 

 Materials and Handling Committee, “Clarification of the definition of Synthetic as it is 

applied to Substances Petitioned for Addition or Prohibition to the National List(s),” 

June 23, 2005 

Material Working Group 

 May 2008 presentation at National Organic Standards Board meeting titled 

“Clarification of Definitions -- Agricultural vs. Non-agricultural” 
Update and Proposed Guidance Document 

Classification of Materials 

April 29, 2011

Page 5 of 5

 November 2008 presentation at National Organic Standards Board meeting titled 

“Clarification of Definitions -- Agricultural vs. Non-agricultural” 

 May 2009 presentation at National Organic Standards Board meeting titled 

“Clarification of Definition of Synthetic Substance” 

National Organic Program 

 Memorandum for the Chairman of the National Organic Standards Board, “National 

Organic Standards Board Recommendations (April 2010 & November 2009),” 

September 30, 2010 

 “Evaluation of the NOSB Recommendation on the Definition of Synthetic,” March 9, 

2006 

 

Committee Vote 

Motion: To rescind our April 2010 recommendation adding a second sentence to the definition 

of chemical change 

Motion: Katrina Heinze Second: Tina Ellor 

Yes: 6 No: 0 Absent: 0 Abstain: 0 Recuse: 0 

Motion: move to accept this update to the public and the proposed guidance that a significant 

level of a synthetic substance in the final material means a level exceeding any applicable 

regulatory limits, where in effect for the material being classified, and a level without any 

technical and functional effects in the final material. 

Motion: Katrina Heinze Second: Tina Ellor 

Yes: 4 No: 2 Absent: 0 Abstain: 0 Recuse: 0