Handling:Nucleotides 

National Organic Standards Board 

Handling Subcommittee 

Petitioned Material Proposal 

Nucleotides 

August 21, 2012 

Summary of Proposed Action: 

Nucleotides are compounds that are made in the body from amino acids. These amino acids 

are abundant in whole foods with protein. The synthetic form has been petitioned for use in 

infant formula to increase levels of nucleotides to those in human breast milk. 

Nucleotides are not mandated to be added to infant formulas under the FDA in 21 CFR 104.20, 

107.100 or 107.10, as clarified in the NOP proposed rule on Nutrient Vitamins and Minerals. It 

may also be possible to make or extract them from non-synthetic sources, although that is not 

commercially done at this time. The Handling Sub-committee is recommending to add synthetic 

nucleotides to the National List.

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 ☐ No ☐

N/A 

3. Compatibility & Consistency x Yes ☐ No ☐

N/A 

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

N/A 

as Organic (only for § 205.606) 

Substance Fails Criteria Category: [ ] Comments: 

Proposed Annotation (if any): 

Nucleotides—allowed for infant formulas only in the “organic” and “made with organic 

categories”. Nucleotides are allowed for the “made with organic claim” on all other food 

products. 

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 nucleotides as synthetic. 

Motion by: Tracy Favre Seconded by: Harold Austin 

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

Listing Motion: 

Motion to list Nucleotides for inclusion on 205.605(b) allowed for infant formulas only in the 

“organic” and “made with organic categories”. Nucleotides are allowed for the “made with 

organic claim” on all other food products. 

Motion by: John Foster Seconded by: Jean Richardson 

Yes: 4 No: 3 Abstain: 0 temporary Absent: Recuse: 0 

Crops ☐ Agricultural ☐ Allowed1 X

☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling x Synthetic x Rejected3

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

1

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

any): 

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: 

Approved by Committee Chair to Transmit to NOSB 

John Foster, Committee Chair August 21, 2012 

NOSB Evaluation Criteria for Substances Added To the National List 

Category 1. Adverse impacts on humans or the environment? 

Substance: Nucleotides 

Question Yes No N/A1

Documentation or Justification

1. Are there adverse effects on 

environment from manufacture, use, or 

disposal? 

[§205.600 b.2]

x 

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 X 
Handling:Nucleotides 

or 3 inerts? [§6517 c (1)(B)(ii); 

205.601(m)2]

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 tolerances? 

[§205.600 b.5]

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.
Handling:Nucleotides 

NOSB Evaluation Criteria for Substances Added To the National List 

Category 2. Is the Substance Essential for Organic Production? 

Substance: Nucleotides 

Question Yes No N/A1

Documentation or Justification

1. Is the substance formulated or 

manufactured by a chemical process? 

[6502 (21)] 

X 

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 Substances are natural, but they are 

synthetic when produced for 

commercial use

3. Is the substance created by naturally 

occurring biological processes? [6502 

(21)] 

X They are created via natural 

processes, but synthetic systems are 

created to generate large volumes of 

these

4. Is there a natural source of the 

substance? [§205.600 b.1] 

X Yes, but not available in the quantity 

needed for commercial production

5. Is there an organic substitute? [§205.600 

b.1] 

X 

6. Is the substance essential for handling of 

organically produced agricultural 

products? [§205.600 b.6] 

X 

7. Is there a wholly natural substitute 

product? 

[§6517 c (1)(A)(ii)] 

X X Yeast may be a suitable alternative. 

Breast milk. 

8. Is the substance used in handling, not 

synthetic, but not organically produced? 

[§6517 c (1)(B)(iii)] 

X 

9. Are there any alternative substances? 

[§6518 m.6] 

X X See 7 above. 

10. Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6] 

X X See 7 above. 

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. 

 
Handling:Nucleotides 

NOSB Evaluation Criteria for Substances Added To the National List 

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

Substance: Nucleotides 

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X Not an essential nutrient, vitamin, or 

mineral.

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 

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 

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; 

c. pheromones, soaps, horticultural 

oils, fish emulsions, treated seed, 

vitamins and minerals?

 

d. livestock parasiticides and 

medicines?

 

e. production aids including netting, 

tree wraps and seals, insect traps, 

sticky barriers, row covers, and 

equipment cleaners?

 

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. 
Handling:Nucleotides 

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: Nucleotides 

Question Yes No N/A1

Documentation or Justification

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

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:Regions of production 

(including factors such as climate and 

number of regions);

 x

a. Number of suppliers and amount 

produced;

 

b. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts 

that may temporarily halt 

 
Handling:Nucleotides 

production or destroy crops or 

supplies; 

c. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

 

d. Are there other issues which may 

present a challenge to a 

consistent supply?

 

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.