Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: the National Organic Program (NOP)

Date: April 27, 2016

Subject: Petition to add Oat Beta Glucan at §205.606 

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 beta glucan, not be added to the National List 

at §205.606. 

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

The NOSB determined that the petitioned material, oat beta glucan failed the evaluation criteria of 

essentiality & availability. The Board found no compelling reason why an organic version of the 

petitioned substance could not be produced. 

NOSB Vote: 

Classification Motion: Move to classify oat beta glucan as agricultural 

Motion by: Lisa de Lima 

Seconded by: Ashley Swaffar

Yes: 15 No: 0 Abstain: 0 Absent: 0 Recuse: 0

Listing Motion: Move to list oat beta glucan at §205.606

Motion by: Lisa de Lima 

Seconded by: Jean Richardson

Yes: 0 No: 15 Abstain: 0 Absent: 0 Recuse: 0

 

Motion Failed
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal - Oat Beta Glucan

January 19, 2016

Summary of Proposed Action:

Oat beta glucan is being petitioned by manufacturer Tate & Lyle for addition at §205.606, as a natural 

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

through a simple process of grinding, enzyme treatment, water extraction and drying. No synthetic 

chemical additions or solvents are used in the manufacturing process being petitioned. The only 

additives used in producing oat beta glucan are water and enzymes. Specifically, the enzyme is foodgrade alpha-amylase and non-GMO per GRAS self-determination. In addition to the beta glucan, 

dextrains and gluco-oligosaccharides are found in the final product, which is in powder form. 

Due to oat beta glucan’s high soluble fiber content, bland flavor and minimal impact at low use levels, its

used to supplement fiber content in processed foods including biscuits, cakes, breads, cereals, bars, 

soups, and smoothies. Other common names for oat beta glucan include oat bran soluble fiber, oat 

fiber, oat soluble fiber, and oat bran fiber. 

Overall, oat beta glucan appears to have no significant negative impacts on human health. There have 

been studies that show the positive effect of the substance on lowering cholesterol and modulating 

blood glucose. 

The petition concludes that since oat beta glucan is used in handling, and not crop production, it has no 

effect on soil, crops, or livestock. The subcommittee however would like to point out that according to 

the USDA pesticide data program there are 7 pesticide residues found on conventionally grown oats. 

The petition states that currently there is no source of organic oat beta glucan, despite organic oats and 

organics 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 beta glucan is manufactured, organic oats and organic 

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

glucan was to increase, the Nordic manufacturing facilities could purchase organic oats and organic oat 

bran from the U.S. The petitioner thought this scenario was unlikely to happen soon due to the 

undetermined demand for oat beta glucan in organic form and that it would be more likely to happen if 

the use of non-organic beta glucan in organic foods was successful first. 

The handling subcommittee would like to point out that the global market is the universe of supply, noncommercial availability is not dependent upon geographical location. The subcommittee sees no reason 

why oat beta glucan could not be manufactured organically. In fact, the manufacturer Garuda 

International used to produce organic oat beta glucan but stopped doing so due to low demand. 
Evaluation Criteria (see attached checklist for criteria in each category)

Criteria Satisfied? 

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes X No ☐N/A

3. Compatibility & Consistency X Yes ☐ No ☐ N/A

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes X No ☐ N/A

as Organic (only for §205.606)

Substance Fails Criteria Category: 2- Essentiality and Availability. Comments: The Subcommittee felt 

that there were alternatives currently available and alternative sources for which these petitioned needs 

could be met.

Subcommittee Action & Vote, including classification proposal (state actual motion):

Classification Motion: Move to classify Oat Beta Glucan as agricultural

Motion by: Lisa de Lima 

Seconded by: Ashley Swaffar

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

Listing Motion: Move to list Oat Beta Glucan at §205.606 of the National List

Motion by: Lisa de Lima 

Seconded by: Jean Richardson

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

 

Approved by Harold V. Austin IV, Handling Subcommittee Chair, to transmit to NOSB January 19, 2016

NOSB Evaluation Criteria for Substances Added To the National List - Handling

Category 1. Adverse impacts on humans or the environment? Oat beta glucan 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use or 

misuse of the substance?

[§205.600(b)(2), [§6518(m)(3)]

x x Produced from non-organic oat, which 

according to the USDA pesticide data 

program, can contain 7 pesticide residues. 

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the substance?

[§6518(m)(3)]

x

3. Are there any adverse impacts on 

biodiversity? (§205.200)

x

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

x
5. Is there undesirable persistence or 

concentration of the material or breakdown 

products in the environment? [§6518(m)(2)]

x

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added to it? 

[§6517(c))(1)(A)(i); 6517 (c)(2)(A)(i); 

§6518(m)(4), 205.600(b)(3)]

x

7. Is the substance, and any ancillary 

substances, GRAS when used according to 

FDA’s good manufacturing practices? 

[§205.600(b)(5)]

x

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 (b)(5)]

x

Category 2. Is the Substance Essential for Organic Production? Oat beta glucan

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] x

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

x

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

x

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

x Yes, natural because it uses enzymes. 

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

x

6. Is there an organic substitute? 

[§205.600(b)(1)]

x Currently no. Former producer of organic oat 

beta glucan stopped producing due to low 

demand.

7. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600(b)(6)]

x

8. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

x x Currently no, but could be made from 

organic oats

9. Are there any alternative substances? 

[§6518(m)(6)]

x x Yes, but petition claims they are unpalatable

10. Is there another practice (in farming or 

handling) that would make the substance 

unnecessary? [§6518(m)(6)]

x
11. Have the ancillary substances associated 

with the primary substance been reviewed? 

Describe, along with any proposed 

limitations. 

x No ancillaries reported in the petition 

Category 3. Is the substance compatible with organic handling practices? Oat beta glucan 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

handling? [§6517(c)(1)(A)(iii); 

6517(c)(2)(A)(ii)]

x

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible with 

organic handling? [§205.600(b)(2)]

x

3. Is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

x Not used in farming 

4. Are the ancillary substances reviewed 

compatible with organic handling [?

x Not ancillary substances identified in petition 

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

x

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

x Primary use is to increase fiber 

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values 

lost in processing (except when required by 

law)? [§205.600(b)(4)]

x Primary use is to increase fiber

Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially unavailable? 

[§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Oat Beta Glucan

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the comparative description as to why the 

non-organic form of the material /substance 

is necessary for use in organic handling

provided? 

x Page 4 of the petition 

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? 

x x Page 12 of the petition gives their 

justification. 

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 

x Page 12 petition
appropriate quality to fulfill an essential 

function in a system of organic handling? 

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?

x Page 12 petition 

5. Does the industry information about 

unavailability include (but is not limited to) 

the following?:

a. Regions of production (including factors 

such as climate and number of regions);

x

b. Number of suppliers and amount 

produced;

x

c. Current and historical supplies related to 

weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; 

x

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

x

e. Other issues which may present a 

challenge to a consistent supply?