FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: May 24, 2010

Subject: Classification of Materials 

Chair: Dan Giacomini 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: X 

Guidance Statement: X 

Other: ________ 

Summary Statement of the Recommendation (including Recount of Vote):

A joint committee of the Materials and Handling committee presented an addendum recommendation to 

complete the National Organic Standards Board recommendation on Classification of Materials made in 

November 2009. The key element of this recommendation was the definition of chemical change. 

The joint committee, in its posted recommendation dated 3/1/10, recommended that the following underlined 

sentence be added to the NOSB’s November 2009 recommendation for chemical change (shown here in italics): 

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”). 

Allowed processing, as defined in §205.2, that has only agricultural or nonsynthetic inputs, does not 

result in a substantive change in identity as it applies to the definition of this term.

Public comment was received in response to this posted 3/1/10 recommendation stating that the added, 

underlined, sentence was too expansive and would reclassify materials previously classified as synthetic to be 

non-synthetic. That was not the joint committee’s intent. The joint committee had added the second sentence in 

response to public comment received at the November 2009 meeting that stated that the first sentence alone 

reclassified too many materials currently classified as non-synthetic to be synthetic. It has been the joint 

committee’s intent to clarify the current definitions to best match current practice and to provide clarity for those 

few materials where classification has proved elusive. 

Based on public comment received prior to and at the April 2010 meeting, the joint committee presented this 

definition of chemical change: 

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.

There were two no votes for this recommendation. One person voting against the addendum recommendation 

did so because they would not have supported the original November 2009 recommendation. The second person 

voting against this recommendation did so because they were unclear whether the added language would allow 

use of a synthetic “allowed” for use in handling to be used to produce a material that could then be used as an 

input for crops or livestock. It was not the intent of the joint committee or the NOSB during discussion to allow 

April 29, 2010 Page 1 of 5 
a “back door” for “allowed” inputs from handling to be allowed in crops or livestock without being explicitly 

evaluated and listed on the National List. 

The joint committee also added language to the recommendation indicating our desire to work closely with the 

National Organic Program to implement both this and the November 2009 recommendation. We specifically 

asked that where possible this recommendation be implemented as guidance. 

The remaining work of the joint committee is development of a draft guidance document, in collaboration with 

the National Organic Program, based on the November 2009 recommendation and this, April 2010, addendum to 

that recommendation. That remaining work will be done by the NOSB Materials Committee. 

NOSB Vote: Motion: Katrina Heinze Second: Joe Smillie

Board vote: Yes - 12 No- 2 Abstain- 0 Absent - 1 

Summary Rationale Supporting Recommendation (including consistency with OFPA and NOP): See 

accompanying recommendation

Response by the NOP:

April 29, 2010 Page 2 of 5 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 3 of 5 

I. Introduction 

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

recommendation on Classification of Materials. The recommendation acknowledged that there were 

a few public comments that needed additional study and stated our intent to add clarifications to our 

recommendation to address these public comments. Since the November meeting, the Joint 

Materials and Handling committee has been reviewing these public comments. The 

recommendation offered below is in response to those comments and addresses the outstanding 

items in the November recommendation. 

II. Recommendation & Discussion 

Public comment asked the NOSB to clarify our support for “the principle that the terms “synthetic” 

and “chemical change” were intended to identify materials that are man-made synthesized 

compounds.” Similarly, we were asked to address “whether chemical changes generated during 

processing methods specifically allowed in the OFPA and/or allowed National List materials, would 

render an otherwise agricultural product “synthetic.” 

There was a consistent concern, expressed in public comment, that our recommended definitions 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 Joint Materials and Handling committee agrees. It is our belief that chemical changes that occur 

when an agricultural material is processed by itself, or in combination with other agricultural 

materials, the resulting material should continue to be classified as agricultural. Clearly chemical 

change happens in these cases, if looked at from a purely chemistry perspective, but from a 

consumer perspective these materials are agricultural. 

The Joint committee discussed whether the same perspective applied when an agricultural material is 

processed with a nonsynthetic material. We decided that again consumers perceive these materials 

to be agricultural. As a result, the Joint Committee decided to include these cases, agricultural 

processed with nonsynthetic inputs, in this addendum to our recommendation and is interested in 

public comment on this topic. 

As a result, we are proposing this addition to the definition of chemical change proposed in our 

November 2009 recommendation. The addition is underlined: 

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 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 4 of 5 

§205.605 / §205.606 for handling), does not result in chemical change as it applies to 

classification of materials.

III. Other Items 

At the November 2009 NOSB meeting, we also received public comment asking the NOSB to 

modify our recommendation to “require organic preference for all ingredients in organic products, by 

applying the principle to all materials currently listed in sections 605 and 606 of the National List.” 

These comments supported a recommendation by the Material Working Group and other comments we 

have received in the past several years. 

We neglected to address this topic in our November 2009 recommendation. Many members of the Joint 

Materials and Handling committee support requiring commercial availability materials listed on 

§205.605 in addition to those listed on §205.606. Unfortunately, it is our understanding from the 

National Organic Program that there does not appear to be a regulatory option for expanding commercial 

availability to §205.605. We request that the NOP continue to be aware of the public and NOSB’s desire 

to explore this topic. 

IV. Update on Next Steps 

The November 2009 NOSB recommendation included a number of steps needed to implement that 

recommendation. Below is an update to the public on the status of execution of these next steps: 

Rule Change – In our November recommendation, we asked the NOP to begin the process for rule 

change when they received the recommendation from the NOSB. With this addendum, we are 

instead asking the NOP to begin the process of reviewing this recommendation for the purpose of 

facilitating a relevant rule change and/or developing industry guidance. Where possible, we would 

like this recommendation to be implemented in industry guidance for some period of time prior to 

rule change. The NOSB asks that the NOP provides feedback to the NOSB regarding its review and 

works collaboratively with its members to address any areas of concern. We ask the NOP to 

prioritize the review of and response to this recommendation, so that increased consistency in 

classification of materials can be implemented quickly. 

Guidance Document – A draft Guidance Document based on the November 2009 recommendation is 

being presented at the April 2010 NOSB meeting. It is the intent of the members of the Joint 

Materials and Handling committee to solicit written feedback from the public on the clarity of the 

guidance document so that we can refine it in collaboration with the NOP. 

Approval and Classification of Materials by Accredited Certifying Agents – We want to reiterate that 

it is critical that ACA’s and other industry stakeholders are consistent in how this recommendation is 

implemented. For that purpose, it is our intent that: 

• ACA’s should approve use of materials as currently listed on the National List. 
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 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 5 of 5 

• ACA’s should begin using the classification of materials guidance document only when 

issued by the NOP as official guidance. Until then, classification of materials for the 

purposes of approving or prohibiting them for use should be done following current 

practices. 

Changes to National List – The Crops, Handling and Livestock committees have added a review of 

materials on their respective sections of the National List for appropriate classification to their 

workplans. The committees are currently working through Sunset materials and will prioritize 

reclassification as appropriate given other workplan items. 

Products from Naturally Occurring Biological Processes – The NOSB will review petitions for 

materials that fall into this category as we receive them. It continues to be our intent to use these 

petitions to expand our knowledge of this category so that additional guidance on classification of 

these materials can be made to the Guidance Document on Classification at a later date as 

appropriate. 

The NOSB received a petition for the reclassification of yeast as agricultural in mid-February. The 

Handling committee will be reviewing the petition, requesting a technical review and intends to have 

a recommendation on the reclassification for our fall 2010 meeting. 

NOSB Practices – The Joint Materials and Handling committee has asked the Policy committee to 

review the recommended practices and incorporate them into the NOSB Policy Manual as 

appropriate. 

COMMITTEE VOTE: 

The Joint Handling and Materials Committee moves to accept this document for full board 

consideration and vote: 

Moved: Katrina Heinze Second: Joe Dickson 

Yes: 9 No: 2 Abstain: 0 Absent: 0 Recuse: 0 
National Organic Standards Board 

Joint Materials and Handling Committee 

Recommendation on Classification of Materials 

November 4, 2009 

 

I. Introduction 

The proper classification of materials has been debated since the Organic Food Production Act was 

enacted. The National Organic Standards Board (NOSB) and the United States Department of 

Agriculture’s (USDA) Accredited certifying agents (ACAs) often are confronted with decisions 

about the classification of materials according to current definitions under the National Organic 

Program (NOP) regulations. For both the NOSB and ACAs, this determination has significant 

impact on organic producers and processors. 

For crops and livestock production, the synthetic/nonsynthetic classification determines whether a 

material is prohibited or allowed. For handling, all nonorganic materials used in certified organic 

products must be on the National List. However, for products that are labeled as “made with 

(organic ingredient)” nonorganic, agricultural ingredients can be used. In this case, the 

agricultural/nonagricultural classification can impact whether a particular material can be used as an 

ingredient without listing. 

While the NOSB determines the classification of some materials when considering the material for 

inclusion on the National List of Allowed and Prohibited Materials (NL), most materials are 

classified by ACA’s and outside technical groups (e.g., OMRI). There is general agreement on the 

vast majority of materials. However, a small number of materials have been problematic, and 

inconsistency in classification exists due to gaps in current definitions. Examples of these materials 

include gums (which are listed in multiple sections on the National List), products of naturally 

occurring biological processes, and natural flavors. 

The need to provide additional clarity on the definition of materials for the National List has been 

recognized for several years. Since 2005, the National Organic Standards Board has been actively 

working to provide increased clarity on the “definition (or classification) of materials.” A number of 

recommendations have been made, public comment has been heard and thoughtful debates have 

occurred. After the November 2007 NOSB meeting, a group of the organic community came 

together as the Material Working Group (MWG) to provide discussion and perspective for NOSB 

consideration. This group was open to anyone interested. Key documents are listed in Section VII 

References. 

The joint Materials and Handling Committee has reviewed past recommendations, National Organic 

Program (NOP) responses, input of the Material Working Group and public comments received over 

the years. We acknowledge that there will always be areas of disagreement on the topic of materials 

classification and that not everyone will agree with our recommendation. The overwhelming 

majority of the input we have received has asked us to make a decisive recommendation that will 

bring clarity to this subject. This recommendation represents the majority view of the members of 

the joint Materials and Handling Committee. 

 

November 4, 2009 Page 1 of 16 
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Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 2 of 5 

II. Scope 

This recommendation applies to the inputs and ingredients used in crop production, livestock 

production and handling. Products that are being reviewed for certification as organic or “made with 

(organic ingredients)” are addressed broadly by all portions of the Final Rule and are outside the 

scope of this document. 

III. Current Regulatory Framework 

In crop production, nonsynthetic substances are allowed unless listed on the NL §205.602, while 

synthetic substances are prohibited unless listed on the NL §205.601. 

In livestock production, nonsynthetic substances are allowed unless included on the NL §205.604, 

while synthetic substances are prohibited unless included on the NL §205.603. 

For handling, nonorganic agricultural substances to be used in certified “organic” products for 

human consumption must be listed on the NL §205.606. Nonagricultural substances must be listed 

on the NL §205.605 with nonsynthetics listed on §205.605(a) and synthetics listed on §205.605(b). 

“Made with” products can contain non-organic agricultural products not included on NL §205.606. 

Materials listed on the NL §205.606 may only be used when the organic version is not available in 

the form, quality, or quantity needed. 

1) The Organic Food Production Act of 1990 

The Organic Food Production Act (OFPA) was passed by Congress in 1990 and signed by the 

President. One of the three defined purposes of the act was “to establish national standards 

governing the marketing of certain agricultural products as organically produced products” 

(§2102(1)). 

The act defines Agricultural Products as “any agricultural commodity or product, whether raw or 

processed, including any commodity of product derived from livestock that is marketing in the United 

States for human or livestock consumption” (§2103(1)). 

The act defines Organically Produced as “an agricultural product that is produced and handled in 

accordance with this title” (§2103 (14)). 

Synthetic is defined as “a substance that is formulated or manufactured by a chemical process or by 

a process that chemically changes a substance extracted from a naturally occurring plant, animal, or 

mineral sources, except that such term shall not apply to substances created by naturally occurring 

biological processes” (§2103 (21)). 

The act defines Processing as a term meaning “cooking, baking, heating, drying, mixing, grinding, 

churning, separating, extraction, cutting, fermenting, eviscerating, preserving, dehydrating, freezing, 

or otherwise manufacturing, and included the packaging, canning, jarring, or otherwise enclosing 

food in a container” (§2103 (17)). 

OFPA did not define the terms “Agricultural”, “Nonagricultural”, or “Nonsynthetic”. 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 3 of 5 

2) The National Organic Program and the National Organic Standards Board 

Under the authority of OFPA, the National Organic Program (NOP) was formed within the USDA. 

The Secretary of Agriculture appointed the original members of the NOSB in 1993. By 1994, the 

NOSB was working to develop the NL, a list of approved and prohibited substances (§2103 (12)) for 

use in certified organic food production as directed according to OFPA. At that time, the NOSB 

introduced the distinction between “agricultural products” and “nonagricultural substances”. 

Final organic regulations, known as The Final Rule, were published in 2000. 

The Final Rule defines Nonagricultural substance as “a substance that is not a product of 

agriculture, such as a mineral or bacterial culture that is used as an ingredient in an agricultural 

product. For the purposes of this part, a nonagricultural ingredient also includes any substance, 

such as gums, citric acid, or pectin that is extracted from, isolated from or a fraction of an 

agricultural product so that the identity of the agricultural product is unrecognizable in the extract, 

isolate, or fraction” (§205.2 Terms defined). 

Nonsynthetic (natural) is defined as “a substance that is derived from mineral, plant, or animal 

matter and does not undergo a synthetic process as defined in section 6502 (21) of the Act (7 U.S.C. 

6502(21)). For the purposes of this part, nonsynthetic is used as a synonym for natural as the term 

used in the Act” (§205.2 Terms defined). 

The Final Rule does not specifically define “process” or “synthetic process” and it further clarifies 

the definition of Processing by adding curing, slaughtering, distilling and chilling to the definition 

(§205.2 Terms defined). 

 
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Joint Materials and Handling Committee 

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April 29, 2010 

April 29, 2010 Page 4 of 5 

IV. Discussion 

Our recommendation on classification of materials required debate and discussion on several aspects 

of the question. Each of these is discussed below. 

1) Guiding Principles

The members of the joint Materials and Handling Committee have agreed to several overall 

principles to guide our recommendation. We agree that a material is defined both by the source 

of the inputs to the process and the process used to make the material. For example, tartaric acid 

can be sourced from grape wine or from malic acid. If sourced from grape wine then tartaric 

acid could be a non-synthetic material. Alternatively, tartaric acid sourced from DL-malic acid 

is synthetic. Pectin sourced from an agricultural source, either citrus peel or apple pomace, can 

be classified as either an agricultural product (pectin, high-methoxy) or synthetic (pectin, lowmethoxy) depending on the process used to produce it ranging from extraction with acidified 

water (agricultural) to hexane extraction with ammonia chemical modification (synthetic). 

Since a material is defined by both its source and the process used to make the material, we agree 

that a material, like pectin or tartaric acid, can have multiple classifications. 

We have come to realize through the past several years of discussion on the topic of 

classification of materials that the historical approach of handling agricultural/nonagricultural 

and synthetic/non-synthetic as distinct questions of classification led to confusion. Specifically, 

confusion developed as to the degree of processing that an “agricultural product” could undergo 

to become “nonagricultural” versus the amount of processing for part of it to become 

“synthetic.” 

There is general consensus that the questions of agricultural versus non-agricultural and synthetic 

versus non-synthetic must be linked in some fashion, and that the relationship should be codified 

and formalized. The committee recommends that the questions should be addressed together in 

sequence rather than addressed as two separate parallel questions. Generally we believe that if a 

material, either due to its source or the process by which it is made, is determined to be synthetic, 

that this determination comes first. Then, of those nonsynthetic remaining materials, those with 

a source that is not agricultural would be classified as nonsynthetic. The remaining materials, 

from agricultural sources would be classified as agricultural. 

This leads to the widely debated classification of agricultural synthetics, or materials sourced 

from agriculture but processed in such a way that the final material would be classified as 

synthetic. We recognize that a material can exist, low-methoxy pectin for example, that clearly 

comes from an agricultural source but undergoes chemical change during manufacturing. There 

is strong consensus that this material should be classified as synthetic. We reject the idea of a 

new category of materials, the “agricultural synthetic” materials, as some have suggested. 

Instead, a material of this type would be classified as synthetic and would most correctly be 

referred to as an “agriculturally sourced material which has been processed in such a way as to 

classify the material synthetic.” 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

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Synthetic / Nonsynthetic

There are several parts of the definition of synthetic that have resulted in differences of opinion 

on how certain materials should be classified. These are “formulated and manufactured by a 

chemical process” and “chemically changed.” Questions that arise from these differences of 

opinion for “difficult to classify” materials include: 

• What type chemical change is required for a material to be synthetic? 

• Can synthetic solvents be used for extraction of nonsynthetic materials? 

• What if the material, as available for use, includes minor, or inert, ingredients that are 

synthetic? Is the material then classified as synthetic? 

The NOSB, NOP and MWG documents on these topics provide numerous examples where lack 

of consistency in interpretation exists. The 2005 NOSB recommendation on this topic, resulting 

2006 NOP response and May 2009 MWG refinement were particularly helpful and provide the 

framework for our recommendation. 

When reviewing the MWG recommendation two perspectives existed on the joint Materials and 

Handling Committee on the classification that results from the use of synthetics in a process. 

Some members felt that, consistent with the practice of the NOSB, NOP and ACA’s since the 

mid-1990’s, if the use of a synthetic in a process did not lead to chemical change and the 

synthetic was not present in the final material at significant levels then the resulting material was 

not synthetic. Others felt that any use of a synthetic not on the National List of approved 

synthetics should result in the material being classified as synthetic. These two perspectives 

reflect those discussed by the MWG and provided by the public in comments to the NOSB over 

the years. The majority of the joint committee agreed to proceed with definitions that aligned 

with current practice. The rationale was that we wanted our recommendation to be least 

disruptive to the National List and most consistent with past NOSB actions and historic organic 

industry practice. 

Therefore we are recommending adoption of the definitions proposed by the MWG in their May 

2009 recommendation, with the exception of the definitions for natural source and generic. The 

definitions that we are recommending for addition to §205.2 Terms Defined to clarify the 

classification of materials as synthetic are chemical change, extract, formulate, manufacture, 

naturally occurring biological process and substance. We did not include the definitions for 

natural source and generic in our recommendation because they were only used by the MWG in 

their proposed decision tree. We will review these definitions and include them as needed when 

we propose the guidance document listed in Section V Next Steps and Timing. 

A full discussion of the MWG recommendation can be found in their recommendation. 

However, we want to highlight a few points here as well. 

It is our intent through this recommendation that a material would be classified as synthetic 

when: 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 6 of 5 

• The source of the material is not “from mineral, plant, or animal matter” (from the 

definition of nonsynthetic) and is not a “substance created by naturally occurring 

biological processes” (from the definition of synthetic) or; 

• The process used to manufacture the material is synthetic (per the definition of synthetic 

and clarifying definitions in our recommendation) or; 

• The material contains, at a significant level, a synthetic substance not on the National List 

of allowed synthetics. 

For our recommendation, extraction with a synthetic not on the National List would not result in 

a material being classified as synthetic unless either the extraction resulted in chemical change or 

the synthetic remained in the final material at a significant level. Also, extraction is broadly 

defined to also include mechanical and physical separation in addition to solvent extraction. 

This is consistent with current classification practices. 

Chemical change is defined by this recommendation as “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. As discussed by the MWG in their recommendation, chemical 

change is “an event in which one substance becomes one or more difference substances.” 

Chemical change would not necessarily include processes like ion-exchange or pH adjustment if 

the final material was not a different substance from the initial substance. For clarity, a 

definition of substance is included in the recommendation as well. 

It is not our intent to reclassify as synthetic, products or ingredients that today can be certified 

organic in full compliance with the Final Rule. For example, certified organic soy lecithin exists 

today. It is manufactured from organic soybeans physically separated into oil and soybean meal. 

The soybean oil is then hydrated with water or steam and the lecithin gums are physically 

separated. Certified organic bleached soy lecithin can be manufactured by using less than 5% 

hydrogen peroxide which is a synthetic allowed for use in certified organic products 

(§205.605(b)). 

The MWG spent considerable time discussing the terms insignificant and significant level. We 

concur with their conclusion that a significant level should be determined with reference to the 

applicable regulatory limits for the type of substance, in addition to technical and functional 

effects produced by the residual level of the synthetic. 

Finally, there are materials on the National List or used as allowed nonsynthetics in crops or 

livestock that are available as ingredients only as a formulated product, a combination of 

materials in a recipe or formula. In this case, all the materials are present at significant levels 

and must all be nonsynthetic for the material to be classified as nonsynthetic. The presence of 

any synthetic, including those on the National List of allowed synthetics, would result in 

classification of the formulated material as synthetic. Also, if the act of formulation leads to a 

chemical change, with the exception of chemical change resulting from a naturally occurring 

biological process, then the material is classified as synthetic. A formulated product that 

contains greater than insignificant levels of a synthetic substance may be approved for use in 
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April 29, 2010 

April 29, 2010 Page 7 of 5 

organic production or handling if the synthetic substance appears in the applicable section of the 

National List. 

Formulation is not typically relevant to classification of single materials. Rather formulation 

needs to be considered when a broad category of materials (e.g., natural flavors, enzymes, dairy 

cultures) are classified. In these cases, we recommend that the general type of materials 

commonly used in formulations be evaluated to determine whether any restrictions on source of 

these substances is warranted and expressed as an annotation. Otherwise, all possible 

formulations of such products would be considered acceptable. 

At the November 3-5, 2009 NOSB meeting, public comment was heard on two topics related to 

classification of materials as either synthetic or nonsynthetic. The first was a concern that the 

use of CAS numbers as an example in the definition of substance was not clear. We have 

modified the proposed definition to address this concern. The proposed modifications to our 

recommended definition of “Substance”: 

• NEW -- An element, molecular species, or chemical compound that possesses a 

distinct identity (For example, a distinct identity may be demonstrated through the 

material having a separate Chemical Abstract Service (CAS) number (in some cases 

the same material may have multiple CAS numbers), Codex International Numbering 

System (INS) number, or FDA or other agency standard of identity). 

• ORIGINAL -- An element, molecular species, or chemical compound that possesses a 

distinct identity (e.g., having a separate Chemical Abstract Service (CAS) number, 

Codex International Numbering System (INS) number, or FDA or other agency 

standard of identity). 

The second concern raised by public comment at the November 2009 NOSB meeting requested 

clarification on our recommended third guiding principle and related definition for chemical 

change. Public comments requested clarification as to how the third guiding principle would 

relate to a material from a source that is organic or to a material that undergoes a chemical 

change through the normal effects of food processing or the use of a synthetic allowed on 

§205.605(b). The joint Materials and Handling committee intends to further study these 

questions and address them if possible during development of our recommended Guidance 

Document with NOP. If not possible, we intend to have a further recommendation specific to 

this topic at the Spring 2010 NOSB meeting. 

2) Agricultural / Nonagricultural

The NOSB has discussed recommendations on the classification of a material as either 

agricultural or nonagricultural on several occasions. Products of naturally occurring biological 

processes have been a major point of disagreement and confusion in these discussions. We 

believe that these discussions have also been confounded by discussions of “agricultural 

synthetics,” which are discussed above. 
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April 29, 2010 Page 8 of 5 

When the classification of a material as synthetic or nonsynthetic is addressed first then materials 

from agricultural sources that are processed in such a way as to classify them as synthetic are 

removed from the question of classification of agricultural or nonagricultural. If we then 

determine that the products of naturally occurring biological processes need to be handled on a 

case-by-case basis, as we recommend below, these materials are also, for the time being, 

removed from the question of classification of agricultural or nonagricultural. 

The materials that remain for classification are all nonsynthetic, either agricultural or 

nonagricultural and relatively easy to classify. Materials that are sourced from minerals or 

atmospheric gases are clearly not agricultural and should be classified as nonagricultural. The 

remaining materials are sourced from agriculture and processed in such a way that they are not 

synthetic. We are recommending that these materials be classified as agricultural. Therefore we 

are recommending that the definition of nonagricultural be simplified by deleting “For the 

purposes of this part, a nonagricultural ingredient also includes any substances, such as gums, 

citric acid, or pectin, that is extracted from, isolated from, or a fraction of an agricultural 

product so that the identity of the agricultural product is unrecognizable in the extract, isolate, 

or fraction.” 

This recommendation will lead to the possible need to reclassify several materials currently on 

§205.605(a). Examples of these materials are egg white lysozyme, L-malic acid and agar-agar. 

Each of these will need to be reviewed to better understand source and process. Our 

recommended process for this review is described below in Section V Next Steps and Timing. 

We recognize that for those materials that are reclassified from nonsynthetic to agricultural, 

resulting in the material being listed on 205.606, this requires that use of the material by a 

handler include demonstration by the handler that an organic version of the material is not 

commercially available. We believe this change will provide additional encouragement for 

market innovation to bring organic versions of these materials to market. 

At the November 3-5, 2009 NOSB meeting, public comment was heard that questioned our 

recommended definition of nonagricultural. In reviewing this public comment, the joint 

Materials and Handling Committee realized that we had inadvertently included the wrong 

definition of nonagricultural in our recommendation. Below are the definitions that we 

considered: 

• CURRENT DEFINITION = A substance that is not a product of agriculture, such as a 

mineral or a bacterial culture, that is used as an ingredient in an agricultural product. For 

the purposes of this part, a nonagricultural ingredient also includes any substances, such 

as gums, citric acid, or pectin, that is extracted from, isolated from, or a fraction of an 

agricultural product so that the identity of the agricultural product is unrecognizable in 

the extract, isolate, or fraction 

• PROPOSED DEFINITION = A product, such as a mineral or atmospheric gas that does 

not originate from an agricultural system 
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April 29, 2010 

April 29, 2010 Page 9 of 5 

• DEFINITION WE INTENDED TO PROPOSE = A product, such as a mineral or 

atmospheric gas, that does not originate from agriculture. For the purposes of this part 

agricultural refers to the production or handling of crops or livestock. 

The public comment received at this meeting asked for better clarity on the definition of 

“agricultural system.” We believe that these comments are addressed through recommendation 

of the definition of “nonagricultural” that we intended to recommend. 

3) Products of Naturally Occurring Biological Processes

The classification of products from naturally occurring biological processes has been a great 

source of differences of opinion and confusion. A variety of approaches and perspectives have 

been considered by the NOSB over the past several years. We believe that these different 

perspectives arise from the great variety of sources and processes used to manufacture these 

materials. For example, yeast can be sourced from certified organic grapes or from a yeast strain 

whose original source is unknown because it only exists in purified form in a bottle. Each of 

these sources may affect the classification of yeast. Similarly, the variety of processes and 

process inputs used to manufacture yeast may affect the classification of the material. Therefore, 

we believe that depending on source and process the product of a naturally occurring biological 

process could be either nonsynthetic or agricultural. 

Proper terminology for the products of naturally occurring biological processes and the 

microorganisms that lie at the heart of these biological processes has been elusive. For the 

purposes of this document, the term “products of naturally occurring biological processes” 

includes the microbiological organisms (e.g., yeast, bacteria) used in the process. 

At this time, the joint Materials and Handling Committee does not believe that we have sufficient 

understanding of the variety of sources and processes used to manufacture products of naturally 

occurring biological processes to issue a recommendation that would address all, or even most, 

of these materials. We are recommending that these materials remain classified as currently 

listed on the National List. 

We are recommending that the term “or bacterial culture” be deleted from the definition of 

nonagricultural because we recognize that cultured microorganisms could possibly be classified 

as agricultural. In which case, certified organic versions would be required. We strongly 

support the development of certified organic versions of materials on the National List and want 

to, where practical, encourage that development. 

Therefore, where a manufacturer believes that they can manufacture a product of a naturally 

occurring biological process from sources and using a process that would classify the material as 

agricultural, we would encourage the manufacturer to submit a petition to the NOP that clearly 

details the source and process and aids in our understanding of the breadth of sources and 

processes on the market. We will review the petitioned material, determine classification and list 

as appropriate. 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 10 of 5 

4) NOSB Practices Related to Classification of Materials

There are three practices that the NOSB should implement that would improve consistency in 

classification of materials by the NOSB. Since classification by the NOSB is typically used by 

others in the organic industry as a guide on classification, it follows that improved consistency in 

classification by the NOSB should lead to improved classification across the industry. 

Originally the NOSB held two votes on all materials being considered for listing on the National 

List. A first vote was on the classification of a material. Once, the classification of the material 

was established, a second separate vote to decide to list the material was held. The separate 

votes separated the discussion into two parts. This practice better matches our intent that 

classification and whether a material should be allowed for use in organic production or handling 

are separate decisions. The joint Materials and Handling Committee recommends that this 

practice be re-implemented and that doing so would eliminate some of the confusion that has 

arisen in recent years. 

Second, in recent years the NOSB has tried where possible to avoid the use of annotations. The 

rationale for this was that annotations pose an additional certification challenge. These materials 

are conventionally produced and information on their source and process can be difficult to 

obtain. We support this perspective but feel that in some cases, the use of annotations is 

warranted to provide further guidance for users of the material or certifiers on whether there are 

source or process limitations for a listed material. Annotations of this type exist today (e.g., 

citric acid). We recommend that future listing of materials include any source or process that is 

not included in the listing of the material. There are some current materials on the list that may 

need additional annotation. Our recommended process for this review is described below in 

Section V Next Steps and Timing. 

Finally, the past several years of discussion on classification of materials has been a reminder 

that the source of inputs and the process to produce a certain material can be complicated and 

varied. A full understanding of these variations is needed to accurately make classification 

decisions and decisions on which variations may be compatible with organic production or 

handling. The members of the NOSB intend to refocus on fully understanding the technical 

aspects of a petitioned material and all the variations of source and process available in the 

marketplace to manufacture the material as we discuss classification and listing of a material. 

This will include broader use of technical reviews as appropriate. 

 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 11 of 5 

V. Recommendation 

The recommendation includes 1) guiding principles for classification of materials, 2) future NOSB 

practices and 3) proposed changes and additions to regulatory language. 

1) Guiding Principles

The members of the joint Materials and Handling Committee have agreed to several overall 

principles that should guide the classification of materials. These are: 

• The classification of a material is determined by both the source of the inputs and the 

process used to make the material. 

• The same material can be agricultural, non-synthetic or synthetic depending on source 

and process. 

• If a material is processed such that it is classified as synthetic then the material is 

classified as synthetic regardless of source. A material of this type would most correctly 

be referred to as an “agriculturally sourced material which has been processed in such a 

way as to classify the material synthetic.” Materials that are manufactured in full 

compliance with the final rule are outside the scope of this principle; their status with 

regards to use in organic is not affected by this recommendation. 

2) NOSB Practices

Improved clarity on the classification of materials would result from enhancing current NOSB 

practices. The joint Materials and Handling Committee is recommending that these practices be 

implemented: 

• Voting on the classification of a petitioned material before voting on whether a petitioned 

material should be listed on the National List. 

• Increase, where appropriate, the NOSB’s use of annotations to properly list source or 

process where either are a determining factor for how a material is classified and placed 

on the National List. 

• Refocus on fully understanding the technical aspects of a petitioned material and all the 

variations of source and process available in the marketplace to manufacture the material. 

3) Proposed Regulatory Language

The joint Materials and Handling Committee recommends that the NOP implement rule change 

to clarify classification of materials. We recommend the following additions and changes to the 

regulation: 

§205.2 Terms Defined. 

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”) 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 12 of 5 

Extract To separate, withdraw, or obtain one or more essential constituents of an organism, 

substance or mixture by use of solvents, mechanical or physical methods. 

Formulate To combine different materials according to a recipe or formula to prepare the 

product being evaluated. 

Manufacture To make a crop, livestock or handling input from raw materials. 

Nonagricultural Substance A product, such as a mineral or atmospheric gas, that does not 

originate from agriculture. For the purposes of this part agricultural refers to the production 

or handling of crops or livestock. 

Replaces the current definition, which is: A substance that is not a product of agriculture, 

such as a mineral or a bacterial culture, that is used as an ingredient in an agricultural 

product. For the purposes of this part, a nonagricultural ingredient also includes any 

substances, such as gums, citric acid, or pectin, that is extracted from, isolated from, or a 

fraction of an agricultural product so that the identity of the agricultural product is 

unrecognizable in the extract, isolate, or fraction. 

Naturally Occurring Biological Process Chemical changes that occur in living cells or due 

to the action of products of living organisms, such as enzymes. 

Substance An element, molecular species, or chemical compound that possesses a distinct 

identity (For example, a distinct identity may be demonstrated through the material having a 

separate Chemical Abstract Service (CAS) number (in some cases the same material may 

have multiple CAS numbers), Codex International Numbering System (INS) number, or 

FDA or other agency standard of identity). 

 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 13 of 5 

VI. Next Steps & Timing 

We recognize that implementation of this recommendation could be disruptive if coordination 

between the NOSB, NOP, and ACA’s on timing does not occur. Therefore, we propose the 

following next steps and timing for implementation of this recommendation: 

Rule Change – We ask the NOP to begin the process of rule change when this recommendation is 

made by the NOSB. We understand that the process for rule change takes time so we intend to 

proceed with guidance (see below) in collaboration with the NOP, so that increased consistency in 

classification of materials can be implemented quickly. 

Guidance Document – We propose to work with the NOP staff to develop a guidance document to 

aid in classification of materials. The guidance document will include appropriate definitions, a 

discussion of each definition as appropriate, clarification that listing on 205.605(a) requires 

verification that source and process to produce the material are not synthetic, clarification that 

nonsynthetic versions of materials listed on 205.605(b) are allowed and classification examples for 

various materials. Additionally, if possible, it will include a decision tree. We propose to begin 

work immediately with the NOP on this guidance document. Once complete, the guidance 

document will be issued by the NOP for public comment and will be reviewed and issued per the 

NOP process for guidance (see “National Organic Program: Development, Issuance, and Use of 

Guidance Documents,” Federal Register, Vol. 70, No. 20, February 1, 2005). Anyone classifying 

materials should follow current practices until this guidance is issued by the NOP. 

Based on public comment received at the November 3-5, 2009 NOSB meeting we intend in the 

Guidance Document to address questions raised about the scope of our third recommended guiding 

principle, questions about interpretation of §205.270(c)2 and provide better guidance for 

determining “significant level.” 

Approval and Classification of Materials by Accredited Certifying Agents – It will be critical that 

ACA’s and other industry stakeholders are consistent in how this recommendation is implemented. 

For that purpose, it is our intent that: 

• ACA’s should approve use of materials as currently listed on the National List. 

• ACA’s should begin using the classification of materials guidance document only when 

issued by the NOP as official guidance. Until then, classification of materials for the 

purposes of approving or prohibiting them for use should be done following current 

practices. 

Changes to National List – This recommendation will require the review of the classification and/or 

annotation for several materials currently on the National List. The Materials Committee in 

collaboration with the Handling Committee will review materials on §205.605 and §205.606 to 

finalize those materials needing a classification or annotation review. The process for changing 

these listings is for a member of the NOSB to submit a petition to the NOP to change the listing for 

the material. It is our intention to submit a petition in time for the spring 2010 meeting and to 

address recommendations to change the listing of these materials at the fall 2010 and spring 2011 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 14 of 5 

meetings. This process will allow any necessary changes to the National List to occur following our 

normal process, including public input. 

Products from Naturally Occurring Biological Processes – As discussed in Section III Discussion 

above, the members of the joint Materials and Handling Committee feel that a better understanding 

of the specific source and process used to produce a material that is the result of a naturally 

occurring biological process is needed in order for a review of the classification of the material to 

occur. It is our intention that these materials continue to be approved or prohibited based on their 

current listing on the National List. We believe that some of these materials could be reclassified, 

including classification as agricultural, depending on source and process and that these materials 

need to be considered on a case-by-case basis. Therefore, if there are materials whose classification 

is unclear, we believe that a petition should be submitted to the NOSB for a review of classification 

and listing. The NOSB will determine the classification of the material. It is our belief that, at some 

future time once source and process is better understood, additional rule changes and guidance could 

occur to address the classification of products from naturally occurring biological processes. 

Specifically, yeast has been the subject of much discussion and public comment for several years. 

Currently a petition to change the listing of yeast from §205.605 to §205.606 has been submitted but 

deferred for consideration by the petitioner. We ask the petitioner to revise the petition, as 

appropriate, to ensure that a detailed discussion of the source of inputs and the processes used to 

produce yeast is included. We will consider the petition when it is resubmitted, request a technical 

review if required and will recommend classification of yeast and the appropriate listing of this 

material. 

 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 15 of 5 

VII. Conclusion 

The members of the joint Materials and Handling Committee are grateful for the input we have 

received from the public on this complicated topic. We want to particularly thank the members of 

the Material Working Group for their discussions, examples and recommendations. Their varied 

perspectives were critical in helping us understand where clarity was needed and the impact of our 

recommendation. 

We acknowledge that this recommendation will not satisfy everyone and that there will be materials 

whose classification will, even with this recommendation, be the subject of debate. Where 

discussion will continue to elucidate this topic, we encourage on-going input and examples. 

VIII. References 

National Organic Standards Board Recommendations & other documents: 

y 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 

y Handling Committee, “Recommendations Relative to “Agricultural” and “Nonagricultural” 

Substances,” July 14, 2005 

y Handling Committee and Materials Committee, “Recommendations Relative to 

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

September 15, 2006 

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

October 19, 2007 

Material Working Group 

y May 2008 presentation at National Organic Standards Board meeting titled “Clarification of 

Definitions -- Agricultural vs. Non-agricultural” 

y November 2008 presentation at National Organic Standards Board meeting titled 

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

y May 2009 presentation at National Organic Standards Board meeting titled “Clarification of 

Definition of Synthetic Substance” 

National Organic Program 

y “Evaluation of the NOSB Recommendation on the Definition of Synthetic,” March 9, 2006 

 
National Organic Standards Board 

Joint Materials and Handling Committee 

 Addendum to November 6, 2009 Recommendation on Classification of Materials 

April 29, 2010 

April 29, 2010 Page 16 of 5 

COMMITTEE VOTE: 

The Joint Handling and Materials Committee moves to accept this document for full board 

consideration and vote: 

Moved: Katrina Heinze Second: Joe Smillie 

Yes: 5 No: 1 Abstain: 1 Absent: 1 Recuse: 0