Formal Recommendation by the 

National Organic Standards Board (NOSB) 

to the National Organic Program (NOP)

Date: December 2, 2011

Subject: Arachidonic Acid (ARA) from Fungal Oil Petition

Chair: Tracy Miedema

 

 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action X

Guidance Statement

Other 

Statement of the Recommendation (Including Recount of Vote): 

1) Motion to classify the substance as a “nonagricultural/non-synthetic”

substance appropriate for listing under 7 CFR §205.605(a)

Vote: 12 Yes, 2 No. Motion carried. 

2) Motion to list “Arachidonic Acid (ARA) from fungal oil, not hexane

extracted; other ingredients that are agricultural must be organic” on the

National List at 7 CFR, §205.605(a)

Vote: 10 Yes, 4 No. Motion carried

Rationale Supporting Recommendation (including consistency with 

OFPA and NOP): 

ARA single –cell oil extracted from fungi was petitioned for inclusion

on the National List of Approved Substances at §205.605, and reviewed at the 

November 2011 meeting. The Handling Committee’s recommendation is 

attached. 

The Handling Committee requested and reviewed a Technical Report 

(TR). The Handling Committee agreed with the TR’s finding that the substance 

could be considered a nonsynthetic, nonagricultural substance and proposed

that it be listed on the National List as, “Arachidonic Acid Single Cell Oil”.

At the November meeting, the Handling Committee presented an

addendum to their initial proposal, regarding the “other ingredients” contained in 

the formulations of DHA and ARA. This document was modified slightly during the 

meeting (attached).

The Handling Committee recommendation, addendum and updated 

language for the actual listing on the National List were considered by the full 

board at the public meeting in Savannah, Georgia. The applicable statutory 
review criteria were discussed, and each of the supplemental review factors 

that guided the Handling Committee’s analysis described in the addendum 

were read into the record and extensive testimony and debate was conducted.

The board discussed the findings of the TR and petition. Portions of both 

documents were read into the record as well. After discussion and vote on the 

classification of the material a motion to list the petitioned substance as 

“Arachidonic Acid (ARA) from fungal oil, not hexane extracted; other ingredients

that are agricultural must be organic” was then considered.

NOSB Votes:

Motion to classify DHA from Algal Oil as a “nonagricultural/non-synthetic”

substance appropriate for listing under 7 CFR §205.605(a) T. Miedema

Moved: T. Miedema Second: K. Heinze

Yes: 12 No: 2 Abstain: 0 Absent: 0 Recusal: 0

Motion to list the petitioned substance as “Arachidonic Acid (ARA) from

fungal oil, not hexane extracted; other ingredients that are agricultural must

be organic” on the National List at 7 CFR, §205.605(a)

Moved: J. Foster Second: S. DeMuri

Yes: 10 No: 4 Abstain: 0 Absent: 0 Recusal: 0
National Organic Standards Board

Handling Committee

Petitioned Material Recommendation

Arachidonic acid (ARA) from Fungal Oil

December 2, 2011

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see “B” below)

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: None. Comments:

Proposed Annotation (if any): Not hexane extracted; other ingredients that are agricultural must be organic.

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

Notes: 

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

Classification Motion: to list the material as a non-synthetic, designating the material for §205.605(a).

Motion by: Tracy Miedema Seconded by: Steve DeMuri

Yes: 6 No: 0 Absent: 1 Abstain: 0 Recuse: 0

Listing Motion: to list the petitioned material Arachidonic acid (ARA) from Fungal Oil, not hexane 

extracted; other ingredients that are agricultural must be organic.

Motion by: Tracy Miedema Seconded by: Katrina Heinze

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

Crops ☐ Agricultural ☐ Allowed1 ☒

Livestock ☐ Non-synthetic ☒ Prohibited2 ☐

Handling ☒ Synthetic ☐ Rejected3 ☐

No restriction ☐ Commercial unavailable as organic ☐ Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205.605(a) with Annotation (if any): not 

hexane extracted; other ingredients that are agricultural must be organic.

2

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

Describe why a prohibited substance:

3

Substance was rejected by vote for amending National List to § 205. . Describe why material was 

rejected: 

4

Substance was recommended to be deferred because

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

Steve DeMuri, Committee Chair December 2, 2011
NOSB Evaluation Criteria for Substances Added To the National List

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

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 The TR concluded that the petitioned

substance, ARA Single- cell Oil, is

produced primarily by a “nongenetically-modified soil fungus

Mortierella alpina,” and that the fungus

is safe for consumption by humans and

other life. See TR at lines 204-

205 (fungus “not believed to cause

disease in humans and biota.”)

The TR described the production,

extraction and purification method of

the natural oil. See TR lines 212-256.

The TR noted that the post-extraction

and purification processes “remove

any extraction and purification solvents

from the oil,” see TR at lines 270-73,

and concluded that the removed 

solvents are typically “recycled and

reused.” See TR at 271-2.

Any other impurities such as “trace

metals, and oxidation products” are

“removed physically through

filtration or addition of adsorbents”

See TR at lines 249-50

Lastly, the TR stated at 273: “No

residual hexane from the extraction

process has been detected in

samples of ARA Single-cell Oil using

methods with detection limits of 0.3

ppm.” The TR also cited a single

Swiss study that tested more than

40 non-organic vegetable oils that 

used a similar extraction technology

for hexane residues and concluded

that less than 13% had any

detectable residue and the level was 

“below acceptable tolerances.” See

TR at line 237

See also Question 2 below

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X The TR concluded that the petitioned

substance is produced under completely

controlled conditions--“aerobic

fermentation of the fungus in shake

flasks containing a growth medium.”

See generally TR line212; see also

generally TR lines 204-256 (describing
Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

inputs, manufacturing process and 

waste byproducts) Because the fungus

is grown in a controlled environment,

there appear to be no environmental

issues arising from the process. see

also lines 407-409 (noting FDA

GRAS notice reported no heavy metals

or pesticides detected in petitioned

substance)

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X See Question 2 above, citing TR lines

204-256; see also TR at lines 204-205

(fungus “not believed to cause disease in 

humans and biota.”)

4. Does the substance contain List 1, 2 or 3 

inerts? [§6517 c (1)(B)(ii); 205.601(m)2]

X This is a substance used as an

ingredient in an organic processed food. 

It is not used in production and contains

no listed inerts.

5. Is there potential for detrimental chemical 

interaction with other materials used?

[§6518 m.1]

X The substance is used as an ingredient

in an organic processed food. No

detrimental interactions were noted in the

TR. See TR lines 123-145 (discussing

combinations with substances in 

formulations); see also TR at lines 204-

205 (fungus “not believed to cause

disease in humans and biota.”)

6. Are there adverse biological and 

chemical interactions in agro-ecosystem? 

[§6518 m.5]

X This is a substance used as an

ingredient in an organic processed food.

It is no longer in the agro-ecosystem.

See also TR at lines 204-205 (fungus

“not believed to cause disease in 

humans and biota.”)

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X This is a substance used as an

ingredient in an organic processed food.

It is no longer in the agro-ecosystem.

See also TR at lines 204-205 (fungus

“not believed to cause disease in 

humans and biota.”)

8. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518 m.2]

X This is a substance used as an

ingredient in an organic processed food.

It is no longer in the agro-ecosystem.

See also TR at lines 204-205 (fungus

“not believed to cause disease in 

humans and biota.”)

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment?

[§6518 m.2]

X This is a substance used as an

ingredient in an organic processed food.

It is no longer in the agro-ecosystem.

See also TR at lines 204-205 (fungus

“not believed to cause disease in 

humans and biota.”)

10. Is there any harmful effect on human 

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

§6518 m.4]

X The Safety of the Fungus: The TR

concluded that the scientific literature

regarding the fungus from which the oil is 

extracted discloses that there is no

reason to believe that any harm to

humans or other life will occur. See TR

at lines 204-205.

Health Benefits from Consumption: 

With regard to the health of those that

consume the petitioned substance, the

TR concluded: “Research suggests that
Question Yes No N/A

1 Documentation (TAP; petition; 

regulatory agency; other)

a balanceofARAand DHA are

necessary to the normal growth and

development of infants.” See TR at

lines 126-27TheTR also noted that 

many studieshave reported

“statisticallysignificantimprovements 

to retinalmaturation, visualacuity,and

cognitive function” while one study

cited“reported no benefit.” See TR at

lines 418-32.TheTR appears to

concludethevast bodyof evidence of

health benefits far outweighed the

single study that found nomeasurable

benefit.

TheTR also cited the World Health

Organization(“WHO”) recommendation

that “ARA should be supplied inthe

diets of infants aged0–6months”and

noted the Institute of Medicine has

established intake levels for infants

aged0–6monthsand small children.

SeeTR at lines, 593-596.

Safety Analysis

“ARASingle-cell Oilisgenerally

recognized assafe for hum

an

consumption,evenin vulnerable infant

populations.” See TR at lines, 496-97

The TR cited the“most recent safety 

assessmentofARA Single-cell Oil” in

the scientific literature, TR at lines 448-

52, and summarized itsfindings:“All

results of the genotoxicityassayswere

negative”and“No adverse effects

attributed to consumption of the ARA

Single-cell Oil were observed even at

thehighest dose”whichinthestudy 

was“29-times higher thanthe

anticipated intake” for term infants. See

also TR at lines 459-62 (notingthat 

Australiaand New Zealand“reviewed

thetoxicological database for ARA 

Single-cell Oiland determined that ARA

Single-cell oil did not induceany

histopathological, biochemical, or 

hematologicalchangesthat would be

indicative oftoxicity” at doses farh

igher

than allowed forinfant formula.)

With regard to thesafetyof the

consumptionof the petitioned 

substancebyinfants (theextracted
Question Yes No N/A

1 Documentation (TAP; petition; 

regulatory agency; other)

ARA)the TR at lines 430-32, stated:

“Despite mixed resultsonmanyof the

purported benefits of ARA

supplementation ininfant formula,

adverse effectsin infants fed formulas

enrichedwithARA/DHAhave not been

observed in randomized trials for up to

one year.”

TheTR noted thatanowten year old

from 2001 study reported incidentsof

“flatulence, diarrhea, apnea, andjaundice 

in infantsthatwere fed formulaswith

long-chainPUFA.”

TR at lines 438-9

However, theTR did not did attribute

these common infant ailments to any

particular infant formula ingredient.To

the extentthese commoninfant ailments

have been reportedto FDA as“adverse

e

vents” arising frominfant formula

consumption,FDA’s reviewhas

apparently concluded the events are de

minimis inlightof the nearly universal 

consumption of infant formula, and thus

belowthethreshold of regulatory action.

Excessive Consumption

The TR cited one studythatexamined

“the effect ofincreasing dietary ARA

seven-fold” and concluded, “no effects

on platelet aggregation, bleedingtimes,

balance ofvasoactive metabolites,

serum lipid levels, or immune response

were observed” TR at lines 438-9 In

addition, after reviewof a meta-analysis

of 25 case-control studiesevaluatinga

variety of effects,theTR concluded:“No

effects in humans athigh ARA doses

were identified.” See TR at lines 438-9.

Absence of Contaminants

TheTR accepted thedata provided by

Petitionerthat wasalso provided to the

FDAand concluded:“No residues of

heavy metals or other contaminants

have been reported inARA Single-cell

Oils at levels higher thanFDA

tolerances.” SeeTR at lines 378-9The

TR also accepted as unrebuttedby other 

literature thefindingthat no solvent used

in processing the ARA oilwas

detectable inthefinal product, and that
Question Yes No N/A

1 Documentation (TAP; petition; 

regulatory agency; other)

the sole study inthe scientific literature

that testedmorethan 40 conventional

(non-organic)vegetable oils for residues

from processing solvents found no

residue at an actionable level.

See TR at lines 386-90.

Global Regulatory Treatment on

Safety

Because organicauthoritiesdo not

assess food safety generally,theTR

surveyedafewjurisdictions to assess

the regulatory treatmentbyagencies

chargedwithsafety evaluations. Of

course,theTR noted thatthe

substance is recognized as GRASin

theU.S. See e.g. TR at lines90-92 

(petitioned substance isGRAS); TR,

at lines 616-17 (noting one GRAS

petitionthat cited5safetystudies)

The petitioned substance hasbeen

evaluated froma safety perspectiveby

several countries and multi-lateral

institutions.

See e.g. TR at lines, 459 (citing Australia and New Zealand). In

particular, theTR noted that inCanada

approved the petitioned substance

“after assessingthe toxicology, 

chemistry, microbiology,and nutrition

of ARASCO

®

as a food ingredient.”

See TR at lines 185-89 Other

regulatory approvals for the petitioned

substance for use ininfant formula 

include, Australia,New Zealand,

China, France, and the Netherlands—

of note also, the European Union similarly allows “ARA Single-cell

Oil

from M. alpina" in inf

ant formula. See

TR at lines 190-93 Lastly,theTR

noted thatthe petitioned substance

would fall under Codex’sgeneral rule

for food grade oils that allowstheir use

provided they are freeof prohibited

additives like coloringagents etc. See

TR at lines 197-98.

In theUnited States, ARASingle-cell Oil

is proposed for addition to infant formula

and other organic food products. See TR

at lines 141-143ARA has notcurrently

been petitioned for GRAS designation as
Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

an addition to food items other than

infant formula. See TR at lines, 573-4.

11. Is there an adverse effect on human 

health as defined by applicable Federal 

regulations? [205.600 b.3]

X The TR concluded that there is no

adverse human health impact under

federal regulations. “ARA Single-cell Oil

is considered by FDA as GRAS in infant

formula when used in combination with

docosahexaenoic acid (DHA).” See TR

at lines 90-92 Also, “ARA Single-cell Oil

is generally recognized as safe for

human consumption, even in vulnerable 

infant populations.” See e.g. TR at lines,

496-97ARA is presently allowed for use

solely in infant formula and growing-up

milks. See TR at lines, 650-51.

The TR plainly stated that the state of the

science is that, “adverse effects in

infants fed formulas enriched with 

ARA/DHA have not been observed in

randomized trials for up to one year.”

See TR at lines, 431-32

12. Is the substance GRAS when used 

according to FDA’s good manufacturing 

practices? [§205.600 b.5]

X The TR concluded: “ARA Single-cell Oil

is characterized as GRAS under three

different names submitted by four

different applicants” See TR at lines 332-

36 (citing Martek Biosciences (GRN No.

41), Mead Johnson Nutritionals (GRN

No. 80), Abbott Laboratories (GRN No.

94), and Cargill, Inc. (GRN No. 326)) 

when used in term and preterm infant

formula along with GRAS concentrations

of DHA.

In addition to GRAS status, when

ARA oil appears as an ingredient in

infant formulas, the manufacturers

submit premarket notification to

FDA under section 412 of the

Federal Food, Drug, and Cosmetic Act

(FFDCA). Section 412 of FFDCA

describes the more stringent statutory

requirements that apply to infant formula

as compared to the regulation of other

foods (FDA, 2006).

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 

b.5]

X The TR described the production,

extraction and purification method of the

natural oil. See TR lines 212-256. The

TR noted that the post-extraction and

purification processes “remove any 

extraction and purification solvents from

the oil,” see TR at lines 270-73, and

concluded that the removed solvents are 

typically “recycled and reused.” See TR

at 271-2. 

Any other impurities such as “trace

metals, and oxidation products” are “removed physically through filtration or 
Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

addition of adsorbents” See TR at lines

249-50.

Lastly, the TR cited Petitioner’s

evidence at line 273: “No residual

hexane from the extraction process has

been detected in samples of ARA

Single-cell Oil using methods with 

detection limits of 0.3 ppm.” The TR

also cited a single Swiss study that

tested more than 40 non-organic

vegetable oils that used a similar

extraction technology for hexane

residues and concluded that less than

13% had any detectable residue and the

level was “below acceptable tolerances.”

See TR at line 237.

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. 2

The criteria set forth in 7 CFR §205.600(b) are applicable solely to “synthetic substances used as a processing aid or adjuvant.” The

petitioned substance is not a processing aid or adjuvant. See TR at line 90-94 The TR determined the petitioned substance be a nonsynthetic. See TR at line 286 (“ARA Single-cell Oil does not appear to be a synthetic substance.”) Accordingly, the criteria listed in

§205.600(b) are inapplicable to the petitioned substance. See e.g. 7 CFR §205.600(c)(“Non-synthetics...will be evaluated using the criteria

[in the OFPA].”) However, the TR included review of most of these questions so the results are cited out of an abundance of caution.
NOSB Evaluation Criteria for Substances Added To the National List

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

(ARA) from Fungal Oil

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 The TR concluded the fungus from which

the petitioned substance is isolated is “produced naturally via fermentation” line

260-63, but the extraction process

typically involves a “nonpolar solvent.”

See TR at 263 (“ARA Single-cell Oil is 

produced naturally via fermentation of M.

alpina and some other single-celled

organisms. However, to extract the ARA 

Single-cell Oil from the fungus, a

nonpolar solvent (usually hexane) is

used.”) See TR at 260-63.

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 The TR concluded that the petitioned

substance is a non-synthetic. See TR at

line 286 (“ARA Single-cell Oil does not 

appear to be a synthetic substance.”);

see also TR at lines 274-78 (Applying

National Organic Standards Board

(NOSB) Joint Materials and Handling

Committee draft policy: “extraction with a

synthetic not on the National List would

not result in a material being classified as

synthetic unless either the extraction

resulted in chemical change or the

synthetic remained in the final material at

a significant level”(NOSB,

2010).”)

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)]

X The TR concluded that the petitioned

substance is the product of a biological

process. See TR lines 260-63.

4. Is there a natural source of the substance? 

[§205.600 b.1]

X ARA is present in foods, but for use in

infant formula, or as a supplemental

micronutrient in adult food products, the

ARA must be extracted by a chemical

process. See TR lines 221-240 (noting

extraction methodologies). “Chicken and

eggs are the primary sources of ARA in

the U.S. diet.” TR at lines, 660-61.

5. Is there an organic substitute? [§205.600 b.1] There are no known certified organic

sources of the extracted ARA oil. See

TR lines 466-80 (citing no certified

source of ARA oil).

The TR noted that fish oil is not an

acceptable substitute because (a) “fish

oil is not an organic agricultural product

per se” and (b) “[f]ish oil does not

contain high levels of pre- formed ARA”

thus it must be “supplemented with

another source of ARA (e.g., egg

phospholipid or ARA Single-cell Oil) to

achieve a fatty acid profile for optimal

nutrition” and (c) “fish oil contains high

levels of EPA, which can result in 
adverse effects

ongrowth of pre-term

infants even atlow concentrations.”

See TR at lines, 475-80.

TheTR noted that using organic eggs

as an ARA source is generally not

commerciallyfeasible because

achieving anegg with sufficient

phospholipidsrequires “feeding

chickens the biomass of ARA-

producing fungus.” See TR at lines,

468-72.

TheTR also noted this approach is

generally considered “wastefulof

resources because ARA contentsinegg 

phospholipids are relatively lowand most

of theeggis often discarded after

phospholipid extraction.” (internal

citations omitted) See TR at lines, 303-

07. Based on theTR, the necessary

chicken feed would not be organic

because ARA producing funguswould

have to be added tocompleteits nutrient

profileand it is notan organicmaterial at

thistime.

6. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600 b.6]

XThe petitioned substance is unique

because itis the only plant- based

source of ARAcurrently availableand is

the

most widely used ARAsource in

conventional and organic infant 

formulas. See e.g. TR at lines, 468-69

(“There are threemain sources of ARA

...for supplementinginfant formula: ARA 

Single-cell Oil, fish oil, andegg

phospholipids.”) Unlike animal sources,

such aseggs or animal flesh, ARA from

fungal oil is vegetarian, carries no riskof

containing harmful environmental

contaminantsthat ananimalmayingest,

see TR at line 212 (noting fungus is

grownin flasks) andthere is no literature

suggestingthis production methodology

adversely impacts biodiversity. See TR

at lines 394-95(“No information was

found onthe effect of ARASingle-cell Oil

on the environment or biodiversity”)

7. Is there a wholly natural substitute product?

[§6517 c (1)(A)(ii)]

XTheTR concluded thatthere are“Three

main sources of ARA ...for

supplementinginfantformula:ARA

Single-cellOil,fish oil, and egg

phospholipids.” See TR at lines, 468-69 

The petitioned substanceis the only

plant-based source of ARA.

Id. non-synthetic, non-agricultural

substance under
205.605(a). See TR 286 (“ARA Singlecell Oil does not appear to be a synthetic

substance.”) There is no plant-based 

agricultural substitute for the petitioned

substance. TR at lines, 657-665

(discussing common sources); TR at

lines, 666 (noting “eggs, poultry, beef,

some fish” are principle ARA sources.)

8. Is the substance used in handling, not 

synthetic, but not organically produced?

[§6517 c (1)(B)(iii)]

X The TR concluded the substance is a

non-synthetic, non- agricultural

substance. See TR 286 (“ARA Singlecell Oil does not appear to be a synthetic

substance.”)

9. Is there any alternative substances? 

[§6518 m.6]

X According to the TR, there are no other

plant-based sources of ARA, thus there

is no vegetarian alternative to the

petitioned substance. TR at lines, 657-

665 (discussing common sources); TR

at lines, 666 (noting “eggs, poultry, beef,

some fish” are principle ARA sources in

adult diet.) For infants, the adult

sources are not alternatives. See also

Question 7.

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6]

X The petitioned substance is a food

additive and there are no “practices” that

substitute for its presence. 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 3. Is the substance compatible with organic production practices? Substance: Arachidonic 

acid (ARA) from Fungal 

Oil

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

regulatory agency; other)

1. Is the substance compatible with organic 

handling? [§205.600 b.2]

X The petitioned substance is not the

product of an excluded method and is a

non-synthetic according to the TR.

2. Is the substance consistent with organic 

farming and handling? [§6517 c 

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

X

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

X

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

X The petitioned use of ARA Single-cell Oil

is as a nutritional food ingredient added

to infant formulas. ARA Single-cell Oil is

added to infant formula to increase free 

ARA levels in formula to those

comparable to ARA levels in human

breast milk. TR at lines, 37-40.

5. Is the primary use as a preservative? 

[§205.600 b.4]

X TR at lines, 37-40

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 TR at lines, 37-40

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 The petitioned substance is not used in

production.

b. toxins derived from bacteria; X The petitioned substance is not used in

production.

c. pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals?

X The petitioned substance is not used in

production.

d. livestock parasiticides and 

medicines?

X The petitioned substance is not used in

production.

e. production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleaners?

X The petitioned substance is not used in

production.

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 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: Arachidonic acid (ARA) from Fungal Oil 

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 The substance is not petitioned for

inclusion on 7 CFR §205.606

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 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

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. 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.
Addendum to Handling Committee Recommendation for the Listing of DHA from 

Algal Oil

Addendum to Handling Committee Recommendation for the Listing of 

Arachidonic acid (ARA) from Fungal Oil

Following the posting of the NOSB Handling Committee unanimous 

recommendation to list DHA from algal oil and ARA from fungal oil1 to 

www.regulations.gov on October 18, 2011, and the closing of the public comment period 

on November 13, 2011, the Committee received a “Memorandum to the National 

Organic Standards Board” (“memorandum”) from the National Organic Program (“NOP”) 

dated November 15, 2011. Later the same day, the Handling Committee conducted a 

conference call during which the NOP requested that the Committee revisit its 

recommendations in light of the memorandum and supplement its findings previously 

completed and posted on www.regulations.gov.

Based on to the NOP request, the Committee has reviewed the memorandum 

and the existing record and now issues this addendum to its “Recommendation to List 

“Arachidonic acid (ARA) from fungal oil” and “DHA from algal oil” on 7 C.F.R. 

§205.605(a) This entire document is incorporated into the posted recommendations. 

The NOP memorandum requests the NOSB “develop a policy” regarding the 

“other ingredients” that are found in substances listed on 7 C.F.R. §205.605(a). 

Although the NOP proposes that review of what the memorandum refers to as “other 

ingredients” be conducted “from this point forward,” we do not understand the NOP to be 

suggesting that a policy that is not yet developed can be applied to presently pending 

matters. Nor did the NOP memorandum cite any specific provisions of the OFPA, or 

provide any analysis, that would assist in developing or implementing such evaluative 

criteria. 

The NOP did suggest two possibly relevant questions for future boards to 

consider, which we do not review here because no notice of these questions has 

previously appeared in the public record and minimal fairness and transparency 

principles forbid their consideration or imposition at this time and by this board. 

Instead we consider the NOP direction a request to make explicit that certain 

criteria are already imposed by the OFPA and 7 C.F.R. Part 205 regarding the review of 

“other ingredients” in a compound petitioned substance, and that the results of that 

review are currently only implicit in the currently posted recommendation. “Other 

ingredients” (or components of compound substances that are petitioned) that are 

allowed are those that are authorized for use in food by the following criteria that we 

make explicit here2:

(1) the National List (7 C.F.R. §§’s 205.600-606) or;

(2) mandatory federal requirements (7 U.S.C. §6519(f)) or;

(3) FDA (GRAS) or otherwise (infant formula, food additive, colors etc.) 7 

U.S.C. §6517(c) and 7 U.S.C. §6519(f) or;

 

1 The vote tally on the ARA-related petition was 6 affirmative and one absent.

2 A version of these factors appeared in the comment filed by Martek Biosciences on 

November 13, 2011
(4) EPA (7 U.S.C. §6517(c) and 7 U.S.C. §6519(f) or;

(5) any other federal regulatory agency with primary jurisdiction over that 

substance (7 U.S.C. §6519(f) or;

And any component or ingredient would be disallowed if:

(6) prohibited by federal regulatory action (7 U.S.C. §6517(d)) or;

(7) the direct product of excluded methods under (7 C.F.R. §205.105) or;

(8) contains any toxic heavy metals or toxic residues (7 U.S.C. §6510(a)) 

and; (Petition pgs. 7-8)(metals and impurities not present or removed)

(9) the component or ingredient was not disclosed in the Petition (72 Fed. 

Reg. 2168)

We note that the Petitions, Technical Reviews and our own Checklist review 

revealed that the petitioner’s manufacturing process follows a HAACP protocol, a cGMP 

protocol acceptable to the FDA and that there are no detectable residues of extraction 

solvents, pesticide residues, PCB’s or any heavy metals. Additionally, the record shows 

that, like many other products on the National List, oxidation retardants are used, and 

that the antioxidants perform no antioxidant function in final formulated food products. 

Lastly we note the processing aids identified in the petition are approved generally for 

use in food products and they are not specifically prohibited by any federal regulatory 

action, or the OFPA or 7 CFR Part 205.

In sum, based on the review criteria listed above, the following “other ingredients” 

are allowed in the petitioned substance because they respectively appear on the 

National List, or are allowed by FDA. None are prohibited by regulatory action. None 

are the product of excluded methods. None contain detectable heavy metal residues. 

Each of the “other ingredients,” listed below was fully disclosed in the petitions.

“DHA from Algal Oil”: Tocopherols, Ascorbyl palmitate, rosemary extract, high oleic 

sunflower oil, sunflower lecithin.

“Arachidonic acid (ARA) from fungal oil”: Tocopherols, Ascorbyl palmitate, citric acid, 

rosemary extract, sunflower oil.

Lastly, it is the intent of the Handling Committee that “Arachidonic acid (ARA) 

from fungal oil” and “DHA from algal oil,” upon listing on the National List, authorize 

formulations containing “other ingredients” if and only if the NOSB and NOP are 

provided notice that such materials meet the 9 criteria listed above. 

Motion that "Addendum to Handling Committee Recommendations for the Listing of 

DHA and ARA Nov 19 2011" be appended to each of the published recommendations for 

these materials. Motion made by Tracy Miedema. Seconded by Steve DeMuri Vote 5 

Yes, 1 abstain, 1 absent

.

This document is not intended to set precedent but merely to show the work that 

the Committee completed on these two materials. [statement added December 1, 

2011 and unanimously approved by Handling Committee]