Formal Recommendation 

From: National Organic Standards Board (NOSB) 

To: the National Organic Program (NOP)

Date: 

Subject: 

Chair: 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: 

Other: 

Statement of Recommendation: (Motion # 1) 

 

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

 

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 3DJHUHYLVHGPD

April 11, 2013

Petition to add Barley Beta Fiber to Section 205.606

Mac Stone

 Motion to classify Barley Beta Fiber as petitioned as agricultural 

 

Passed

As per the petition and Technical Report: Barley Beta Fiber and its constituents are non-synthetic when 

extracted by normal processing, including enzymatic hydrolysis. 

John Foster

Jean Richardson

15 0 0 0 0

04/2013 1 of 9 NOSB Recommendation
Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Statement of Recommendation: (Motion # 2)

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 

 

3DJHUHYLVHGPD

Failed

 Motion to list Barley Beta Fiber on section 205.606 of the National List 

 

Upon review of the petition and the technical report, the Handling Subcommittee determined that Barley 

Beta Fiber does not satisfy evaluation criteria #2: 

Essentiality & Availability. 

Having considered the claim in the petition of the unique characteristics of the product the 

Subcommittee requested that interested members of the organic community comment on the supply, 

demand and specific qualities of the petitioned material in an effort to assess the degree to which there is 

an essential market need. Having received no strong support for this substance, the NOSB voted to not 

list Barley Beta Fiber on Section 205.606.

John Foster

Jean Richardson

3 12 0 0 0

04/2013 2 of 9 NOSB Recommendation
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Barley betafiber

December 18, 2012

Summary of Proposed Action:

Barley betafiber is described in the petition as a “polysaccharide of unbranched, linear, mixed-linkage ßglucans” (Kolberg, 2011). Barley betafiber is described at 21 CFR 101.81(c)(2)(ii)(6) as a fraction of 

cellulase and alpha-amylase hydrolyzed whole grain barley. 

Barley betafiber is defined by the FDA as “the ethanol precipitated soluble fraction of cellulase and 

alpha-amylase hydrolyzed whole grain barley. Barley betafiber is produced by hydrolysis of whole 

grain barley flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section, with a cellulase and alphaamylase enzyme preparation, to produce a clear aqueous extract that contains mainly partially 

hydrolyzed beta-glucan and substantially hydrolyzed starch. The soluble, partially hydrolyzed betaglucan is separated from the insoluble material by centrifugation, and after removal of the insoluble 

material, the partially hydrolyzed beta-glucan soluble fiber is separated from the other soluble 

compounds by precipitation with ethanol. The product is then dried, milled and sifted. Barley betafiber 

shall have a beta-glucan soluble fiber content of at least 70 percent on a dry weight basis” [21 CFR 

101.81(c)(2)(ii)(6)]. 

Barley ß-glucan isolates such as barley betafiber enable food processors to incorporate the health 

benefits of barley in various foods without the problems created by whole grain barley in formulation 

(Fastnaught, 2009). The petition refers to it being used in a juice (Kolberg, 2011). Soluble barley 

betafiber is possible to use in other beverages (Zheng, et al., 2004). Other foods where barley 

betafiber has been added, at least experimentally if not commercially, include baked goods, pasta, 

ready-to-eat cereals, soups, stews, dairy products and meats (Newman and Newman, 2008; 

Fastnaught, 2009).

Barley is known to be a rich source of ß-glucan. While most other grains have lower fiber in the 

endosperm than the whole grain, the soluble ß-glucan in barley endosperm is comparable to that of 

whole grain (Henry, 1987). The variety “Prowashonupana” was identified in the early 1980s as a 

mutant hull-less waxy barley with a high ß-glucan content (Eslick, 1981). The ß-glucan in 

Prowashonupana is described as not soluble (WTARC, 2005). Other barley varieties selected for high 

soluble ß-glucan content are Apollo and Wanubet (Yoon et al., 1995). The petitioned substance is 

described as new and at this time the only commercial products that use the petitioned substance are 

processed products that are not certified organic (Kolberg, 2011).

Nutritional fiber has a wide range of technical and functional effects on food (Dreher, 2001; Sharma et 

al., 2008; Cho, 2009). Naturally occurring β-glucans can be classified as Soluble Fibers, while added 

or isolated β-glucans are potential Functional Fibers. Soluble and functional fibers have similar 

activity, but isolated ß-glucan extracts have a wide range of specific characteristics and functionality. 

Barley betafiber is distinguished by its low molecular weight (Zheng, et al., 2004). As discussed 

below, the primary health claim made related to the use of the petitioned substance is its ability to 

reduce the glycemic index of foods, help to maintain normal blood sugar levels, and lower cholesterol, 

decrease risk of diabetes, and “(potentially) promoting satiety” (Kolberg, 2011).

04/2013 3 of 9 NOSB Recommendation
Consistent with the literature noted above, the petition claims specific properties of this barley beta 

fiber that are unique and currently unavailable in organic form to be used as dietary fiber additions in 

product formulations, specifically that the percentages and ratio of soluble to insoluble fiber are 

preferable from a product development standpoint. The petition also claims that the variety of barley 

used for this product is currently not grown in sufficient quantity to satisfy market demand.

The Handling Subcommittee reviewed the petition materials, considered the unique characteristics of 

the variety and product in the petition and reviewed the TR, which addressed the technical aspects of 

the material but not the market dynamics. The Subcommittee requests that interested members of the 

organic community comment on the supply, demand and specific qualities of the petitioned material in 

an effort to assess the degree to which there is an essential market need. 

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see 

“B” below)

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

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

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

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

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments: 

Proposed Annotation (if any): none

Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state actual 

motion):

Classification Motion: Motion to classify barley betafiber as petitioned as agricultural

Motion by: John Foster Seconded by: Joe Dickson

Yes: 8 No: 0 Absent: 0 Abstain: 0 Recuse: 0

Listing Motion: 

Motion by: John Foster Seconded by: Joe Dickson

Yes: 7 No: 0 Absent: 0 Abstain: 1 Recuse: 0

Crops ☐ Agricultural x Allowed1 x

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling x Synthetic ☐ Rejected3 ☐

No restriction ☐ Commercial unavailable as 

organic

x Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any): 

none

Approved by Subcommittee Chair to Transmit to NOSB

John Foster, Subcommittee Chair December 18, 2012

04/2013 4 of 9 NOSB Recommendation
NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? Substance: Barley betafiber 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, use, 

or disposal?

[§205.600 b.2]

X See TR-product is agricultural.

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X “

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X “

4. Does the substance contain List 1, 2

or 3 inerts? [§6517 c (1)(B)(ii); 

205.601(m)2]

X

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X “

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

X

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518 m.2]

X “

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment? 

[§6518 m.2]

X “

10.Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 

c(2)(A)i; §6518 m.4]

X “

11.Is there an adverse effect on human 

health as defined by applicable 

Federal regulations? [205.600 b.3]

X “

12.Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

X “

13.Does the substance contain residues 

of heavy metals or other 

contaminants in excess of FDA 

X Small residual amounts are left in the 

product. TR states <2ppm lead.

04/2013 5 of 9 NOSB Recommendation
tolerances? [§205.600 b.5]

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? Substance: Barley 

betafiber

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

X Chemical reactions are occurring in 

the use of enzymes to break bonds. 

TR.

2. 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 There is a chemical separation of the 

fiber from the barley; that being said it 

is a normal component of the barley

3. Is the substance created by naturally 

occurring biological processes? 

[6502 (21)]

X Natural in that it used enzymes; 

however the enzymes are not 

endogenous to the barley and are 

introduces. That being said, it is a 

normal biologic process.

4. Is there a natural source of the 

substance? [§205.600 b.1]

X

5. Is there an organic substitute? 

[§205.600 b.1]

X TR states that oat 70% β-glucan is 

available organically and not 

mentioned in the petition

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 b.6]

X Not essential; however, it is an 

ingredient that will assist in providing 

for the overall health of the consumer.

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

X

8. Is the substance used in handling, not 

synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

X

9. Is there any alternative substances? 

[§6518 m.6]

X X There are other sources of fiber with 

β-glucans; but these have different 

properties and are not always 

functional in some types of products, 

beverages for example.

10.Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

X

04/2013 6 of 9 NOSB Recommendation
NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Is the substance compatible with organic production practices? 

Substance: Barley betafiber

 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X Consistent with most compatibility 

criteria

2. Is the substance consistent with 

organic farming and handling? [§6517 

c (1)(A)(iii); 6517 c (2)(A)(ii)]

X Several other materials used in 

analogous capacities

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

X Not used in farming

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

X Increased due to the addition of heart 

healthy fiber

5. Is the primary use as a preservative? 

[§205.600 b.4]

X

6. Is the primary use to recreate or 

improve flavors, colors, textures, or 

nutritive values lost in processing 

(except when required by law, e.g., 

vitamin D in milk)? [205.600 b.4]

X Used for increased dietary fiber in 

foods

7. Is the substance used in production, 

and does it contain an active 

synthetic ingredient in the following 

categories:

a. copper and sulfur compounds;

X

b. toxins derived from bacteria; X

c. pheromones, soaps, horticultural 

oils, fish emulsions, treated seed, 

vitamins and minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including netting, 

tree wraps and seals, insect traps, 

sticky barriers, row covers, and 

equipment cleaners?

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

04/2013 7 of 9 NOSB Recommendation
NOSB Evaluation Criteria for Substances Added To the National List

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or 

potentially unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 

205.600 (c)] Substance: Barley betafiber

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the comparative description 

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic 

handling? 

X Petition-pg 8

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 Petition Pg. 8—the variety grown for 

fiber production is not currently in 

organic production

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? 

X Petition Pg. 8

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 Petition Pg. 8

5. Does the industry information 

provided on material / substance 

non-availability as organic, include ( 

but not limited to) the following:

a. Regions of production (including 

factors such as climate and 

number of regions);

X See above

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies 

related to weather events such as 

X

04/2013 8 of 9 NOSB Recommendation
hurricanes, floods, and droughts 

that may temporarily halt 

production or destroy crops or 

supplies; 

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a 

consistent supply?

x

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 

(b) are N/A—not applicable.

NOSB Recommendation