Agricultural Marketing Service

Classification: Update on the 

Development of Draft Guidance

Organic Integrity from Farm to Table, 

Consumers Trust the Organic Label

National Organic Standards Board Meeting

Lisa M. Brines, Ph.D., Standards Division

May 23, 2012

Albuquerque, New Mexico
Agricultural Marketing Service

Background

• NOSB has issued a number of formal recommendations for 

classification (April 2011, May 2010, November 2009, August 2005)

• In a memo to the NOSB on August 11, 2011, the NOP indicated its 

plans to develop draft guidance on classification based upon the 

November 2009 NOSB Recommendation for Classification of 

Materials

• NOP has not yet published draft guidance; this presentation 

provides an overview of the program’s current thinking on these 

issues
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Why is classification guidance needed?

• To ensure consistent determination of synthetic / 

nonsynthetic for inputs

• To ensure consistent determination of agricultural / 

nonagricultural status

• To determine proper placement of materials on National List

• To implement outstanding NOSB Recommendations 
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Purpose of Classification Guidance

• To describe NOP policies related to classification of materials

• To describe procedures used to classify substances as 

synthetic or nonsynthetic, or as agricultural or nonagricultural

• For the classification guidance to be used in conjunction with 

a Permitted Substance List (NOP 5034, in development) for 

crop inputs
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Format for Classification Guidance

Three related documents:

NOP 5033 – Guidance: Classification of Materials

NOP 5033-1 – Synthetic / Nonsynthetic Decision Tree 

NOP 5033-2 – Agricultural / Nonagricultural Decision Tree
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Definitions

• New definitions were included in the NOSB Recommendation 

of April 10, 2011 

• Definitions will not be added to regulations; definitions 

provided and used within the guidance document

• Some definitions to be updated or amended for clarity

• NOP does not intend to amend the definition for 

“nonagricultural” under §205.2 at this time, but could 

consider under a rulemaking action
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Definition: Chemical Change

NOSB Recommended Definition:

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”)

NOP Proposed Clarification:

Chemical change. A process (i.e., chemical reaction) whereby a 

substance is transformed into one or more other distinct 

substances.
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Definition: Extract

NOSB Recommended Definition:

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.

NOP Proposed Clarification:

Extract. To separate, withdraw, or obtain one or more 

constituents of an organism, substance, or mixture by use of 

solvents (dissolution), acid-base extraction, or mechanical or 

physical methods.
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Definition: Substance

The term “substance” is used extensively in the NOP 

regulations, but is not defined under §205.2

NOSB Recommended Definition:

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).
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Definition: Substance

NOP Proposed Clarification:

Substance. A generic type of material, such as an element, 

molecular species, or chemical compound that possesses a 

distinct identity (e.g., having a separate Chemical Abstracts 

Service (CAS) number, Codex International Numbering 

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

identity).
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Crop Inputs: Synthetic / Nonsynthetic

• Classification is needed to determine whether 

substance is allowed, prohibited, or needs to 

be on the National List

• §205.601 – Allowed synthetic inputs

• §205.602 – Prohibited natural inputs

• Other natural substances are allowed
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Crop Inputs: Synthetic / Nonsynthetic

• Classification is to be made according to the decision tree, 

NOP 5033-1

• NOP is developing draft guidance for permitted crop inputs, 

NOP 5034, which lists allowed nonsynthetic and synthetic 

inputs

• Substances not classified on the permitted substances list, 

NOP 5034 (in development) will need a review process

• NOP will review requests for adding nonsynthetic 

substances to NOP 5034 based on classification guidance
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Crop Inputs: Synthetic / Nonsynthetic 

(cont.)

• Substances classified as nonsynthetic on section 205.605(a) of 

the National List are permitted as nonsynthetic crop inputs, 

unless listed on section 205.602 of the National List

• Substances classified as synthetic on section 205.605(b) of the 

National List are prohibited as crop inputs, unless the 

substance is also listed on section 205.601 of the National List

• Substances classified as agricultural on section 205.606 of the 

National List are permitted as crop inputs, unless listed on 

section 205.602 of the National List
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Livestock Inputs

• Classification is needed to determine whether substance is 

allowed or needs to be on the National List

• Classification is needed for livestock feed ingredients to 

determine whether ingredient must be certified organic

• §205.603 – Allowed synthetic inputs

• §205.604 – Prohibited natural inputs

• Other natural substances are generally allowed

• Agricultural substances used for livestock feed must be 

certified organic
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Livestock Inputs

• Classification as synthetic / nonsynthetic is to 

be made according to the decision tree, NOP 

5033-1

• Substances not previously classified by the 

NOSB at a public meeting may need a review 

process
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Livestock Inputs (cont.)

• Substances classified as nonsynthetic on section 205.605(a) of the 

National List are permitted as nonsynthetic livestock inputs, unless listed 

on section 205.604 of the National List

• Substances classified as nonsynthetic in the Permitted Substances List (in 

development) are permitted as nonsynthetic livestock inputs, unless listed 

on section 205.604 of the National List

• Substances classified as synthetic on section 205.605(b) of the National 

List are prohibited as livestock inputs, unless the substance is also listed 

on section 205.603 of the National List

• Substances classified as agricultural on section 205.606 of the National List 

would be permitted as nonsynthetic; livestock feed ingredients must be 

certified organic.
Agricultural Marketing Service

Handling Inputs

• Classification is needed to determine placement of non- organic substances on the National List

• Classification is important for determining allowance of 

non-organic agricultural ingredients in the “made with 

organic” category

• §205.605(a) – Allowed nonsynthetic

• §205.605(b) – Allowed synthetic

• §205.606 – Allowed non-organic, agricultural ingredients 

(subject to commercial availability)
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Handling Inputs: Classification Order

• Classification as agricultural or nonagricultural to 

be made first

• Classification as agricultural or nonagricultural to 

be made according to the decision tree, NOP 

5033-2

• For substances which are nonagricultural, further 

classification as synthetic or nonsynthetic 

according to decision tree NOP 5033-1
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Special Issues

• Separation methods

• Solvents in handling

• Eligibility for organic certification

• Timeline and next steps
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Separation Methods

• Some substances are isolated from mixtures using separation 

techniques

• Separation methods include, but are not limited to distillation, 

solvent extraction, acid-base extraction, and physical or 

mechanical methods (e.g. filtration, crushing, centrifugation, 

gravity separation, etc.)

• The isolated substance may be certified organic, nonsynthetic, 

synthetic, agricultural or nonagricultural, depending on the 

starting material and process used
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Certified Organic Substances

• Materials used as ingredients, extractants, or other processing 

aids must be organic or comply with the National List

• Examples of substances used to extract organic ingredients:

Organic ethanol Citric acid

Water Supercritical carbon dioxide

Sodium hydroxide

• Under § 205.270, use of volatile synthetic solvents or other 

synthetic processing aids are prohibited, unless listed at 

§205.605
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Solvents in handling – what this means

• No synthetic solvents or other synthetic processing aids in or on 

organic products, or in or on organic ingredients, unless listed on 

§205.605

• Solvents may be considered as part of manufacturing process for 

substances on§205.605, that are reviewed by NOSB and not further 

restricted. Examples include: lecithin, pectin, shellac

• Nonorganic agricultural ingredients in “made with” products may 

have been produced with synthetic processing aids and solvents. 

• Non organic ingredients listed on§205.606, for use in organic 

products, may have been produced using synthetic solvents or 

processing aids, unless specifically annotated otherwise. 
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Solvents in handling

§205.270(c) The handler of an organic handling operation 

must not use in or on agricultural products intended to be 

sold, labeled, or represented as “100 percent organic,” 

“organic,” or “made with organic ...,” or in or on any 

ingredients labeled as organic:

(2) A volatile synthetic solvent or other synthetic processing 

aid not allowed under §205.605: Except, That, nonorganic 

ingredients in products labeled “made with organic (specified 

ingredients or food group(s))” are not subject to this 

requirement
Agricultural Marketing Service

Solvents for Non-Organic Substances

• Solvents may used in various ways in the manufacture of a 

substance, e.g., as reaction media, as an extractant, for purification 

or crystallization, concentration standardization, etc.

• NOSB may consider the use of any synthetic substance, including 

solvents, as part of its review of petitioned materials

• Volatile synthetic solvents are prohibited for handling organic 

products under 205.270, unless listed on 205.605. 

• According to the draft guidance, the use of a synthetic solvent in 

the process does not necessarily result in a substance being 

classified as synthetic
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Nonorganic Substances – What separation techniques can result 

in the substance being classified as “nonsynthetic”?

Nonsynthetic substances meet the following criteria:

1. At the end of the extraction process, the substance has not 

been transformed into a different substance via chemical 

change.

Example:

Citric Acid – produced by microbial fermentation of a carbohydrate 

substance, isolated and purified through various techniques, but is 

not transformed into a different substance, classified as 

nonsynthetic on §205.605(a) 
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Nonorganic Substances – What separation techniques can result 

in the substance being classified as “nonsynthetic”?

2. The substance has not been isolated in a form that does 

not occur in nature

Examples: 

Citric acid – Natural when produced by microbial 

fermentation of carbohydrate substances, classified as 

nonsynthetic on §205.605(a) 

Potassium Citrate – A potassium salt of nonsynthetic citric 

acid, classified as synthetic on §205.605(b)
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Nonorganic Substances – What separation techniques can result 

in the substance being classified as “nonsynthetic”?

3. Any synthetic materials used to separate, isolate, or extract the 

substance have been removed from the final substance (e.g., via 

evaporation, distillation, precipitation, or other means) such that 

they have no technical or functional effect in the final product

Example: 

Pyrethrins used as crop input for pest control

Extracted from flowers with a synthetic solvent, solvent is removed 

prior to ingredient formulation (nonsynthetic)
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Nonorganic Substances – What separation techniques can result 

in the substance being classified as “nonsynthetic”? (cont.)

4. When used in crop or livestock production, substances 

used for formulation are nonsynthetic or included on the 

appropriate section of the National List; or

Example: 

Natural botanical pesticides – Inerts must be natural or on 

National List, §205.601(m)
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Nonorganic Substances Used in Handling – Classification as 

Nonsynthetic

5. When used for handling or processing, nonorganic 

substances used for formulation are provided for in the 

NOSB’s review of the substance or are included in the 

substance’s annotation on the National List.

NOP has requested for NOSB to clarify “other ingredients” 

allowed in handling inputs, which is on the workplan for the 

Handling Subcommittee.
Agricultural Marketing Service

Eligibility for Organic Certification

• NOSB had previously recommended other definitions of chemical 

change, to prevent processed agricultural products methods from 

being classified as “synthetic” (May 24, 2010 NOSB 

Recommendation)

• If a substance contains or is made up of agricultural ingredients, and 

can meet the USDA NOP organic production, handling, processing 

and labeling standards, it may be eligible to be certified under the 

NOP regulations

• The classification guidance is not intended to determine the 

eligibility of a substance for organic certification
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NOP 5033-1 Synthetic / Nonsynthetic 

Decision Tree

• Is the substance manufactured, produced, or extracted from a 

natural source?

• Does the substance undergo a chemical change?

• Is the substance created by a natural occurring biological 

process, such as composting, fermentation, or enzymatic 

digestion; or by heating or burning biological matter?
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NOP 5033-1 Synthetic / Nonsynthetic 

Decision Tree

• Is the substance created by a natural occurring biological 

process, such as composting, fermentation, or enzymatic 

processes; or by heating or burning biological matter?

• Is the substance combined with other materials to produce a 

commercial product?

• Are all of the components present in the generic substance 

nonsynthetic? 
Agricultural Marketing Service

Table of Example Classifications with Explanations

Substance Classification Explanation

Ash (burned wood) Nonsynthetic Substance is created by burning biological matter.

Calcium carbonate 

(limestone) Nonsynthetic Substance is produced from a natural source (mined mineral) and does not undergo chemical change.

Calcium oxide 

(quicklime) Synthetic

Substance is produced from a natural source (mined 

mineral), but undergoes chemical change caused by 

heating the mineral.

Citric acid Nonsynthetic

Substance is created from a naturally occurring biological 

process (microbial fermentation of carbohydrate 

substances).

Gibberellic acid Nonsynthetic Substance is extracted from a natural source without 

further chemical change

Newspaper Synthetic Substance is manufactured via a chemical process.

Raw manure Nonsynthetic Substance is from a natural source and used without 

further processing.
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NOP 5033-2 Agricultural/Nonagricultural 

Decision Tree

• Is the substance derived from a plant, animal, microorganism, 

or mineral?

• Is the substance a microorganism (e.g., yeast, bacteria, fungi) 

or an enzyme; or is the substance isolated from the product of 

a microorganism or an enzyme?

• Has the substance been processed to the extent that its 

chemical structure has been changed?
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NOP 5033-2 Agricultural/Nonagricultural 

Decision Tree (continued)

• Is the chemical change a result of naturally occurring 

biological processes such as fermentation or use of enzymes; 

or a result of mechanical/physical processes?

• Have any other ingredients (e.g., additives, carriers, 

preservatives) been added to the substance that remain in the 

final product?

• Are the ingredients consistent with sections 205.605 or 

205.606?
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Table of Example Classifications with Explanations

Substance Classification Explanation

Colors derived from 

agricultural products

Agricultural Substances are derived from plants or animals and have 

not been chemically changed

Bentonite Nonagricultural Substance is a mineral (not from a plant or animal source)

Citric acid Nonagricultural Substance is created from a naturally occurring biological 

process (microbial fermentation of carbohydrate 

substances)

Diatomaceous earth Nonagricultural Derived from a mineral

Enzymes Nonagricultural Derived from a plant, animal, or microorganism
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Timeline – Next Steps

• NOP to publish draft guidance (expect to put in 

clearance in summer of 2012)

• Publication will coincide with draft guidance NOP 

5034, Permitted Substances for Organic Crop 

Production

• Public comment period (min. 60 days)

• NOP to review comments, amend text, and 

publish final guidance
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Thank you!

www.ams.usda.gov/nop | 202-720-3252