Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: The National Organic Program (NOP)

Date: November 27, 2016

Subject: Petitioned Material Proposal – Oat Protein Concentrate 

NOSB Chair: Tracy Favre

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement:

Other: X

Statement of the Recommendation: 

The NOSB recommends that the petitioned material, Oat Protein Concentrate, not be added to the 

National List at §205.606. 

Rationale Supporting Recommendation (including consistency with OFPA and Organic Regulations): 

The NOSB felt the petitioned material, Oat Protein Concentrate, failed the evaluation criteria of 

essentiality & availability. The board saw no reason why an organic version of the petitioned substance 

could not be produced. 

NOSB Vote: 

Classification Motion: Move to classify oat protein concentrate as agricultural 

Motion by: Lisa de Lima 

Seconded by: Tom Chapman

Yes: 14 No: 0 Abstain: 0 Absent: 1 Recuse: 0

Listing Motion: Move to list oat protein concentrate at §205.606

Motion by: Lisa de Lima 

Seconded by: Scott Rice

Yes: 0 No: 14 Abstain: 0 Absent: 1 Recuse: 0

 

Motion Failed
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Oat Protein Concentrate 

May 17, 2016

Summary of 

Petition https://www.ams.usda.gov/sites/default/files/media/Oat%20Protein%20Concentrate.pdf

Oat protein concentrate is being petitioned by manufacturer Tate & Lyle for addition to §205.606, as a 

natural component of oats, an agricultural commodity. According to the petition the substance is 

isolated from oat bran through a simple process of grinding, heating, and water extraction. No synthetic 

chemical additions or solvents are used in the manufacturing process (pH adjustment and/or solvent 

extraction) being petitioned. The only additives used in producing oat protein concentrate are water and 

enzymes. The alpha-amylase enzyme used is derived from a non-pathogenic, non-GE/GM 

microorganism.

Oat protein concentrate is a vegan, non-GMO protein source and is a good source of certain essential 

amino acids. The petition also notes that it has better digestibility that other cereal proteins because it is 

primarily composed of globulin proteins. Additionally, due to its bland flavor and low impact on texture 

it can be used to supplement protein content in a wide range of foods. Examples listed in the petition 

include vegan entrees, cereal bars, baked goods, breakfast cereals, pasta, and meal replacement shakes. 

Overall oat protein concentrate appears to have no significant negative impacts on human health. 

Unlike other proteins used as supplements (milk, soy, egg), this ingredient can be used in foods targeted 

for individuals with these specific allergies. 

The petition states that oat protein concentrate is used in handling, not crop production, and therefore

it has no effect on soil, crops, or livestock. However, the Subcommittee would like to point out that 

according to the USDA pesticide data program there are 7 pesticide residues found on conventionally 

grown oats. Conventionally grown oats are what oat protein concentrate is derived from. 

The petition states that currently there is no source of organic oat protein concentrate, despite organic 

oats and organic oat bran being widely available in the U.S. and Canada. Additionally the petition claims 

that in Nordic countries, where a large amount of oat protein concentrate is manufactured, organic oat 

quantities are limited. The petition goes on to state that if the demand for organic oat protein 

concentrate was to increase, the Nordic manufacturing facilities could purchase organic oats from the 

U.S. The petitioner thought this scenario was unlikely to happen anytime soon due to the undetermined 

demand for oat protein concentrate in organic form. 

Summary of Review:

The Handling Subcommittee would like to point out that geographical location is not sufficient 

justification for arguing the commercial non-availability of a commodity. The Subcommittee sees no 

reason why oat protein concentrate could not be manufactured organically. Therefore, the 

Subcommittee recommends that the petitioned material, oat protein concentrate, should not be placed 
on the National List as it fails the “Essentiality & Availability” criteria, as well as the “Commercial Supply 

is Fragile or Potentially Unavailable as Organic” criteria.

Category 1: Classification 

1. Substance is for: Handling

2. For HANDLING use:

a. Is the substance agricultural or non-agricultural? Substance is agricultural

 Describe reasoning for this decision using NOP 5033-2 as a guide:

Oat protein concentrate is extracted from whole oats. The oats are first de-hulled and then the oat 

bran and oat flour are separated through a dry milling process. Then the oat bran goes through a 

wet milling process, and using alpha-amylase enzyme the protein is separated from the bran. 

The oat protein remains intact throughout the manufacturing process. The protein is isolated 

through grinding, heating, and water extraction. No synthetic chemicals additions or solvents are 

used. 

Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§6518(m)(1)]

N/A

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment? 

[§6518(m)(2)]

N/A

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

N/A

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)].

Oat protein concentrate can be used to boost protein in content in foods that are suitable for 

vegetarians, vegans, and those will allergies to milk, soy, wheat or celiac disease. 

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms 

(including the salt index and solubility of the soil), crops and livestock. [§6518(m)(5)] 

The final substance does not have a direct effect on soil, but the conventional oats from which 

the oat protein concentrate is extracted, could. According to the USDA pesticide data program 

there are 7 pesticide residues found on conventionally grown oats. 
6. Are there any adverse impacts on biodiversity? (§205.200)

The final substance does not have a direct effect on soil, but the conventional oats from which 

the oat protein concentrate is extracted, could. According to the USDA pesticide data program 

there are 7 pesticide residues found on conventionally grown oats. 

Category 3: Alternatives/Compatibility

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)]

The alternative to using the substance would be to create an organic oat protein concentrate 

from organic oats. Additionally, there are other organic vegan proteins available on the market,

for example: soy, hemp, pea, rice, quinoa, sunflower, pumpkin, mushroom, chia, amaranth,

lentil, flax, goji, and peanut. 

2. For Livestock substances, and Nonsynthetic substances used in Handling: In balancing the 

responses to the criteria above, is the substance compatible with a system of sustainable 

agriculture? [§6518(m)(7)]

No. 

Category 4: Additional criteria for synthetic substances used in Handling (does not apply to 

nonsynthetic or agricultural substances used in organic handling):

N/A. Oat protein concentrate is agricultural 

Describe how the petitioned substance meets or fails to meet each numbered criterion.

1. The substance cannot be produced from a natural source and there are no organic substitutes; 

(§205.600(b)(1))

2. The substance's manufacture, use, and disposal do not have adverse effects on the environment 

and are done in a manner compatible with organic handling; (§205.600(b)(2))

3. The nutritional quality of the food is maintained when the substance is used, and the substance, 

itself, or its breakdown products do not have an adverse effect on human health as defined by 

applicable Federal regulations; (§205.600(b)(3)

4. The substance's primary use is not as a preservative or to recreate or improve flavors, colors, 

textures, or nutritive value lost during processing, except where the replacement of nutrients is 

required by law; (§205.600(b)(4))

5. The substance is listed as generally recognized as safe (GRAS) by the Food and Drug 

Administration (FDA) when used in accordance with FDA's good manufacturing practices (GMP) 

and contains no residues of heavy metals or other contaminants in excess of tolerances set by 

FDA; (§205.600(b)(5))
Yes, oat protein is GRAS. Designated GRN No. 000575

6. The substance is essential for the handling of organically produced agricultural products. 

(§205.600(b)(6))

7. In balancing the responses to the criteria in Category 4, is the substance compatible with a 

system of sustainable agriculture [§6518(m)(7)] and compatible with organic handling? (see 

NOSB Recommendation, Compatibility with Organic Production and Handling, April 2004) 

Category 5: Additional criteria for agricultural substances used in handling (review of commercial 

unavailability of organic sources):

1. Is a comparative description given as to why the non-organic form of the material /substance is 

necessary for use in organic handling provided? 

Yes, but not persuasive. 

2. Does the current and historical industry information, research, or evidence provided explain 

how or why the material /substance cannot be obtained organically in the appropriate form to 

fulfill an essential function in a system of organic handling?

No. 

3. Does the current and historical industry information, research, or evidence provided explain 

how or why the material /substance cannot be obtained organically in the appropriate quality to 

fulfill an essential function in a system of organic handling?

No.

4. Does the current and historical industry information, research, or evidence provided explain 

how or why the material /substance cannot be obtained organically in the appropriate quantity 

to fulfill an essential function in a system of organic handling?

The petition claims that in Nordic countries, where a large amount of oat protein concentrate is 

manufactured, organic oat quantities are limited. The Nordic manufacturing facilities could 

purchase organic oats from the elsewhere, if they determined the demand for organic oat protein 

concentrate was sufficient for justifying manufacture of the substance. Additionally, the 

subcommittee believes there are organic oats available in Europe. 

5. Does the industry information about unavailability include (but is not limited to) the following:

Regions of production (including factors such as climate and number of regions);

a. Number of suppliers and amount produced;

No. 

b. Current and historical supplies related to weather events such as hurricanes, floods, and 

droughts that may temporarily halt production or destroy crops or supplies;

No. 
c. Trade-related issues such as evidence of hoarding, war, trade barriers, or civil unrest that 

may temporarily restrict supplies; or

No. 

d. Other issues which may present a challenge to a consistent supply?

No. 

6. In balancing the responses to the criteria in Categories 2, 3 and 5, is the substance compatible 

with a system of sustainable agriculture [§6518(m)(7)] and compatible with organic handling? 

(see NOSB Recommendation, Compatibility with Organic Production and Handling, April 2004) 

No. The Handling Subcommittee sees no reason why an organic form of oat protein concentrate 

could not be produced. Additionally, oat protein concentrate does not appear to be necessary in 

organic handling. 

Classification Motion: 

Motion to classify oat protein concentrate as petitioned as agricultural. 

Motion by: Lisa de Lima

Seconded by: Tom Chapman

Yes: 6 No: 0 Abstain: 0 Absent: 2 Recuse: 0 

Listing Motion: 

Motion to add oat protein concentrate as petitioned at §205.606

Motion by: Lisa de Lima

Seconded by: Scott Rice 

Yes: 0 No: 6 Abstain: 0 Absent: 2 Recuse: 0