Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: the National Organic Program (NOP)

Date: April 2015

Subject: Petition to add Whole Algal Flour at §205.605(a)

NOSB Chair: Jean Richardson

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement:

Other: X 

Statement of the Recommendation (Motion #1): 

Motion to classify Whole Algal Flour (WAF) as non-synthetic, passed. 

Statement of the Recommendation (Motion #2): 

Motion to add Whole Algal Flour at §205.605(a) - Nonagricultural (nonorganic) substances 

allowed as ingredients in or on processed products labeled as “organic” or “made with organic 

(specified ingredients or food group(s))” (a) Nonsynthetics allowed, failed.

Rationale Supporting Recommendation (including consistency with OFPA and Organic 

Regulations): 

Based on mixed public comment and the information provided in the petition, the NOSB 

determined that Whole Algal flour, while non-synthetic, is not essential to organic handling and 

is inconsistent with fundamental organic principles. As such, it would not meet the expectations 

of organic consumers, handlers, or others within the organic community. 

Committee Vote: 

Motion to classify Whole Algal Flour (WAF) as non-synthetic. 

Motion by: Harold Austin 

Seconded by: Jean Richardson

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

Motion passed
Motion to add Whole Algal Flour at §205.605(a) - Nonagricultural (nonorganic) substances 

allowed as ingredients in or on processed products labeled as “organic” or “made with organic 

(specified ingredients or food group(s))” (a) Nonsynthetics allowed

Motion by: Harold Austin

Seconded by: Jean Richardson 

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

Motion failed 
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal - Whole Algal Flour

January 6, 2015

Summary of Proposed Action:

The Handling Subcommittee (HS) has again reviewed the petition and additional information 

submitted by Solazyme, Inc. seeking permission to have Whole Algal Flour (WAF) added to the 

National List of Approved Materials. (This material was referred back to the Handling 

Subcommittee at the Louisville National Organic Standards Board (NOSB meeting). The 

Handling Subcommittee proposes to recommend adding WAF to the National List at 

§205.605(a) - Nonagricultural (non-organic) substance (non-synthetic) allowed. Originally, the 

Handling Subcommittee considered adding WAF to the National List under §205.606 – 

Nonorganic agricultural products allowed as an ingredient in or on processed product; however, 

our discussion and further considerations during the original proposal presentation to the full 

Board at the NOSB meetings (specifically, at the October 2014 NOSB Fall meeting in Louisville

led us to determine §205.606 is not the appropriate place to list this material. To be consistent 

with other materials already listed and to follow the guidelines of the Draft Decision Tree, the 

Handling Subcommittee decided this material belongs on §205.605(a) rather than on §205.606.

Background: Whole Algal Flour is manufactured from, a microalgae by fermenting and 

harvesting cultures of a non-toxigenic strain of Chlorella protothecoides. The petitioner originally 

proposed listing this material on §205.606 yet noted that algae is also a single-celled organism, 

and as such, we could place it on §205.605(a). Its primary proposed use would be: a whole 

food ingredient used as either a partial replacement for food ingredients that provide dietary fat 

and/or protein such as cream, milk, eggs/egg yolks, and/or butter or shortening in baked goods, 

beverages, dairy and egg products, sauces, gravies, margarines, salad dressings and soups, or 

as an added ingredient for texture and mouth feel enhancement.

 

On September 6, 2013, the National Organic Program received the original petition and 

forwarded it to the NOSB’s Handling Subcommittee for petition review and consideration for 

listing. On January 14, 2014, the Handling Subcommittee received a supplement from the 

petitioner: a response to questions that the HS had concerning whole algal flour after our review 

of the original petition. Both the original petition and the supplemental information contained 

confidential business information, requiring redaction. The redacted information made it difficult 

for the Handling Subcommittee to thoroughly review this material and its ancillary substances.

During the 30day public comment period prior to the NOSB’s October 2014 fall meeting in 

Louisville, the petitioner provided additional information to the Handling Subcommittee. This 

information clarified some points of concern. Additionally, the petitioner (and others) provided 

more information and questions to the NOSB during oral public presentation and questions,. 

There were 14 written public comments submitted for whole algal flour; While Six commenters 

opposed listing whole algal flour on §205.606, eight supported adding whole algal flour to that 

Section. Those opposed were concerned with: 1) the amount of information withheld as 

confidential business information; 2) the fermentation process (as a whole, not just this 

material); 3) excluded methods, using a synthetic material to replace already existing organic 

alternatives; and 4) ancillary substances. Those that supported adding whole algal flour to the 

National List stated that it would not replace organic substances currently being used but give 
handlers an alternative – to make a finished product that can provide a healthier organic 

product – a nonallergenic, vegan option. Materials used currently could be partially replaced by 

whole algal flour; this replacement could help to reduce calories, fat, saturated fat, and 

cholesterol while not impacting taste, mouth feel, or end product quality.

Discussion:

The petitioner provided the Handling Subcommittee (during written public comment and their 

oral comments) answers to several areas of concern that they had previously had. The HS

resolved the concerns related to ancillary substances, especially the Subcommittee’s

requirement of a due diligence review even though some of the information was redacted. The 

two ancillary substances used are antioxidants: tocopherols and ascorbic acid; both are 

currently listed on the National List at §205.605(b). Consequently, the NOSB’s ancillary 

substance review of a petitioned material is complete. 

Another concern was the manufacturing process via fermentation and the media used during 

the process. A detailed list of those materials used in the fermentation growth medium was 

provided. This list was very typical of substances normally used in the fermentation process of 

other materials currently allowed on the National List. The petitioner provided two examples of 

two materials currently on the National List at §205.605 that are also products of fermentation; 

these are: Gellan gum at §205.605(a) and Xanthan gum at §205.605(b)

The petitioner also assured the Subcommittee and the full Board that no excluded methods 

were used by them to manufacture whole algal flour. This, together with the materials used in 

their manufacturing process, would be subject to review by their certifier at each annual 

inspection, and as it reviews their Organic System Plan during certification renewal.

Regarding essentiality, the Handling Subcommittee discussed whether or not this material is 

essential to organic handling. Part of the original discussion was based on the belief that this 

material would replace currently used “organic” materials (organic milk, eggs, cream, etc.) or 

practices. While that is partially true, it is not the petitioner’s reason for seeking to add Whole 

Algal Flour to the National List. The primary reason is to provide handlers with an option, so that 

they might be able to provide those organic consumers with allergen concerns to eggs and/or 

dairy products, an alternative choice of a non-allergenic option to their finished goods. It would 

also help provide an alternative to those looking for a vegetarian or vegan alternative in organic 

consumer goods. Is there currently an alternative for this material based on its intended use? 

The answer is no. Does this material offer something to a handler currently not accessible to 

their manufacturing process? The answer is possibly. Could this material be considered 

essential to a handler to formulate a lower in calorie, low fat, vegan, or a non-allergenic 

alternative to what is currently being manufactured? The answer could then be considered 

possibly yes. While there will be differences of opinion, we must look at what this material could

provide the organic community if it were listed, versus the consequences if it is not allowed. 

The Handling Subcommittee has decided that Whole Algal Flour is not essential to organic 

handling. The Subcommittee also recognizes that this use is inconsistent with the basic 

fundamental principles of organics and, as such, would not meet the expectations of organic 

consumers, handlers, or others within the organic community.

Explanation of Motions: During the October 2014 Fall meeting in Louisville, a classification 

motion was not voted on by the Subcommittee due to the redacted information pertaining to the 

manufacturing process and ancillary substances. Once the petitioner provided additional 
information 1) this issue was reconsidered and brought to a proper vote by the Subcommittee, 

and 2) we decided to add whole algal flour to the National List at §205.605(a) instead of at 

§205.606 as originally proposed in the listing motion. The motion is presented below.

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

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

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

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

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

as Organic (only for §205.606)

Substance Fails Criteria Category: 2, 3 

Comments: During its discussion about whole algal flour, particularly whether or not it should 

be added to the National List, the Handling Subcommittee decided the following: it is not 

essential to organic handling and it is inconsistent with basic organic principles (replacing 

organic materials currently being used with this product). 

Subcommittee Action & Vote

Classification Motion: Move to classify Whole Algal Flour (WAF) as non synthetic. 

Motion by: Harold Austin 

Seconded by: Jean Richardson 

Yes: 5 No: 0 Absent: 3 Abstain 0 Recuse: 0 

Listing Motion: Move to add Whole Algal Flour at §205.605(a) – Nonagricultural 

(nonorganic) substances allowed as ingredients in or on processed products labeled 

as “organic” or “made with organic (specified ingredients or food group(s))” (a) 

Nonsynthetics allowed

Motion by: Harold Austin 

Seconded by: Jean Richardson 

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

 Proposed Annotation (if any): none

Approved by Harold Austin, Handling Subcommittee Chair, to transmit to NOSB, January 

6, 2015

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

Category 1. Adverse impacts on humans or the environment? Substance: Whole Algal Flour 

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 It would not appear that there would be 

any adverse effects on the environment 

from the use or misuse of this material.

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 It would not appear that there would be 

any adverse effects to the environment 

from the manufacture or disposal of this 

substance.

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 Page 6 and 7 of the petition for whole 

algal flour states that on June 7, 2013 the 

FDA issued a No Questions letter (GRN 

469) for whole algal flour. The petitioner 

has self-affirmed whole algal flour to be 

GRAS, page 4 of the petition. The two 

declared ancillary substances used in 

whole algal flour (as stated in the 

petitioner’s written public comments 

dated October 6, 2014) were mixed 

tocopherol and ascorbic acid (both of 

these materials are currently listed on the 

National List at §205.605(b).

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? Whole Algal Flour

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

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X Petitioner claims that it should be 

classified as a microorganism and is 

nonagricultural. 

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Made by fermentation process in a closed 

system. 

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 Goes through fermentation and has either 

potassium hydroxide or sodium hydroxide 

added to adjust the pH. (both are on the 

national list).

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X Fermentation has been considered to be 

a natural process.

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 Organic milk, cream, eggs/egg yolks are 

currently being used and others. But, 

these do not serve the same as the 

intended purpose of whole algal flour.

7. Is the substance essential for handling of 

organically produced agricultural 

products? [§205.600(b)(6)] 

X X There currently are alternatives being 

used. It could be considered essential, if 

it were considered that it can help to 

provide an alternative to currently used 

organic materials to provide a nonallergen/vegan alternative to those 

organic consumers needing an 

alternative choice. 

8. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

X There could be wholly natural substitutes 

for this product, in part. But, for the 

intended use of this material there would 

not be a wholly natural substitute product 

currently available.

9. Are there any alternative substances? 

[§6518(m)(6)] 

X There are substances currently on the 

National List of Approved Substances 

that are being used such as: starch 

products, some of the gums, 

hydrocolloids, to name just a few.

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 In the petitioners written public comments 

(October 6, 2014) they identified two 

ancillary substances used in the 

production of whole algal flour; those

were: mixed tocopherol and ascorbic 

acid, both are listed on the National List 

at §205.605(b).

Category 3. Is the substance compatible with organic handling practices? Whole Algal Flour

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 It is consistent with other materials 

currently allowed in organic handling and 

also currently on the National List.

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X

4. Are the ancillary substances reviewed 

compatible with organic handling?

X The ancillary substances were reviewed 

and found to be compatible with organic 

handling. The two ancillary substances 

identified are both currently on the 

National List.

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

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 The primary use is to reduce and replace 

substances currently being used to help 

reduce fat content, improve texture and 

mouth feel in some products. The 

substance is used to provide a nonallergenic and vegan alternative to 

materials currently used in organic 

handling.
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)] Whole Algal Flour

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 There currently is not an organic form of 

this substance available on the market for 

use in organic handling.

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

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

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

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 Unknown

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?

X