National Organic Standards Board | Fall 2012 Meeting

i 

National Organic Standards Board Meeting

Biltmore Hotel | Providence, RI

October 15, 2012 – October 18, 2012

Title Page

Agenda 1

Livestock Subcommittee | Wendy Fulwider, Chairperson

Proposal: Nonanoic acid (pelargonic acid) 9

Proposal: Pet Food Amino Acids 16

Discussion document: Omnivore diets (methionine) 24

GMO ad hoc Subcommittee | Zea Sonnabend, Chairperson

Discussion document: GMOs and seed purity 29

Crops Subcommittee | Jay Feldman, Chairperson 

Proposal: Biodegradable Mulch Film Made From Bioplastics 35

Proposal: Ferric Phosphate (2009 Petition to remove) 50

Proposal: Oxidized lignite (humic acid) 64

Proposal: Propylene glycol monolaurate (PGML) 71

Proposal: Review of Inert Ingredients 78

Proposal: Rotenone 85

Proposal: Sulfuric acid 92

Materials Subcommittee | Jennifer Taylor, Chairperson

Proposal: Research Priorities 101
ii

Handling Subcommittee | John Foster, Chairperson

Proposal: Ascorbyl palmitate 107

Proposal: Beta-carotene 117

Proposal: Lutein 127

Proposal: Lycopene 136

Proposal: L-Carnitine 144

Proposal: L-Methionine 153

Proposal: Nucleotides 161

Proposal: Taurine 168

Discussion document: Auxiliary/”other” ingredients 175

Policy Development Subcommittee | Colehour Bondera, Chairperson

Proposal: Conflict of Interest and Ethics 209

Proposal: Public Comment Procedures 216

Proposal: Public Communications 221

Compliance, Accreditation, and Certification Subcommittee | Joe Dickson, Chairperson

Discussion document: Calculating Percentage of Organic Ingredients 225

Discussion document: Biodiversity update 230
USDA-AMS | National Organic Program

 National Organic Standards Board | Fall 2012 Meeting Agenda, Revised 10/03/2012

 1 

National Organic Standards Board Meeting

Providence, RI, October 15-18, 2012 

Agenda 

 Schedule at a Glance 

Monday 

Oct 15

Tuesday

Oct 16

Wednesday

Oct 17

Thursday

Oct 18

AM - Call to Order

- Secretary’s Report 

- NOP Update 

- Open Public 

 Comment 

- GMO ad-hoc 

 Subcommittee 

- Crops 

 Subcommittee 

- Handling 

Subcommittee 

- Compliance, Accreditation 

 & Certification 

 Subcommittee 

- Deferred Items

- Final Votes

PM - Livestock 

 Subcommittee 

 

- Materials 

 Subcommittee 

 

- Policy 

 Development 

 Subcommittee 

 

- Officer Elections

- Subcommittee Work Plans

- Other Business 

- Closing Remarks

Meeting Format

• The USDA National Organic Program (NOP) National List Manager presents an overview of petitioned 

substances and Technical Reports in consistent format. 

• NOSB members present Subcommittee discussion documents and proposals on petitioned substances.

• Public comments are grouped to correspond with each Subcommittee’s presentation. 

• Each Subcommittee’s proposals are discussed and may be voted on by the Board before moving to the next 

Subcommittee.

• If more deliberation is needed, final votes will be deferred to Thursday, October 18. 

• NOTE: Agenda items may be withdrawn or votes may be postponed at the discretion of the Board. 

 Public Comments

• All persons wishing to comment at NOSB meetings during public comment periods should sign up in advance. 

Commenters can sign up in person at the meeting if the schedule allows. 

• Each commenter must state their name and affiliation for the record at the beginning of his or her public 

comment.

• Each person may sign up for only one speaking slot. Speakers have been allotted 4 minutes to testify with 3 

minutes for questions and answers from the Board. 
USDA-AMS | National Organic Program

 National Organic Standards Board | Fall 2012 Meeting Agenda, Revised 10/03/2012

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Monday, October 15

8:00 AM Call to Order

Dr. Barry Flamm, Chairperson

- Announcements

- Introductions

- NOSB Mission

8:15 AM Secretary’s Report

Dr. Wendy Fulwider, Secretary

- Acceptance of May 2012 Meeting Transcripts and Voting Results as Official 

Record

8:30 AM National Organic Program Update

Miles McEvoy, Deputy Administrator, National Organic Program

Mark Lipson, Organic and Sustainable Agriculture Policy Advisor, OSEC-MRP

9:30 AM Break

9:45 AM Open Public Comment 

- Public comments that are not specific to a particular Subcommittee, or which

address topics not on the agenda 

12:00 PM Lunch

1:00 PM Open Public Comment continued

2:15 PM Livestock Subcommittee 

Dr. Wendy Fulwider, Chairperson 

- Present Subcommittee proposals and summarize written comments 

Topics:

- Proposal: Nonanoic acid (pelargonic acid) - petitioned

- Proposal: Pet Food Amino Acids - petitioned

- Discussion document: Omnivore diets (methionine)

- GMO Vaccines Working Group update: Dr. Jean Richardson (15 min)

3:00 PM Break

3:15 PM - Public comments related to Livestock Subcommittee 

4:45 PM - Break for Subcommittee to modify proposals as needed

- Board votes if ready

5:30 PM Recess
USDA-AMS | National Organic Program

 National Organic Standards Board | Fall 2012 Meeting Agenda, Revised 10/03/2012

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Tuesday, October 16

8:00 AM GMO Ad Hoc Subcommittee

Zea Sonnabend, Chairperson

- Present Subcommittee proposal and summarize written comments 

Topics: 

- Discussion document: GMOs and seed purity 

8:15 AM - Public comments related to GMO Ad Hoc Subcommittee 

9:05 AM Break

9:20 AM Crops Subcommittee 

Jay Feldman, Chairperson 

- Present Subcommittee proposals and summarize written comments

Topics:

- Proposal: Ferric Phosphate - petitioned

- Proposal: Oxidized lignite (humic acid) - petitioned

- Proposal: Propylene glycol monolaurate (PGML)- petitioned 

- Proposal: Review of Inert Ingredients

- Proposal: Rotenone (For 205.602)

- Proposal: Sulfuric acid - petitioned 

- Proposal: Biodegradable Mulch Film Made From Bioplastics – petitioned 

11:00 AM - Update from the Tree Fruit Working Group: David Granatstein 

- Presentation: Consumers Union: Dr. Urvashi Rangan 

- Presentation: Organic Seed Alliance: Kiki Hubbard 

12:15 PM LUNCH

1:15 PM - Public comments related to Crops Subcommittee 

3:20 PM Break

3:35 PM - Break for Subcommittee to modify proposals as needed

- Board votes if ready
USDA-AMS | National Organic Program

 National Organic Standards Board | Fall 2012 Meeting Agenda, Revised 10/03/2012

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Tuesday, October 16

4:15 PM Materials Subcommittee 

Dr. Jennifer Taylor, Chairperson

- Present Subcommittee proposals and summarize written comments 

Topics:

- Proposal: Research Priorities 

4:30 PM - Public comments related to Materials Subcommittee 

4:45 PM - Break for Subcommittee to modify proposals as needed 

- Board votes if ready 

5:00 PM Recess
USDA-AMS | National Organic Program

 National Organic Standards Board | Fall 2012 Meeting Agenda, Revised 10/03/2012

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Wednesday, October 17

8:00 AM Handling Subcommittee

John Foster, Chairperson

- Present Subcommittee proposals and summarize written comments

- Representatives from the American Academy of Pediatrics (AAP) (Dr. Jatinder

Bhatia) and the Food and Drug Administration (FDA) (Dr. Sue Anderson), 

invited by the NOP, will be available to respond to Board member questions.

Topics: 

- Proposal: Ascorbyl palmitate - petitioned

- Proposal: Beta-carotene (synthetic) - petitioned 

- Proposal: Lutein - petitioned

- Proposal: Lycopene - petitioned

- Proposal: L-Carnitine - petitioned

- Proposal: L-Methionine - petitioned

- Proposal: Taurine - petitioned

- Proposal: Nucleotides - petitioned

- Discussion document: Auxiliary/”other” ingredients

10:00 AM BREAK

10:15 AM - Public comments related to Handling Subcommittee 

12:30 PM LUNCH (until 1:45 when Handling Subcommittee returns from break)

1:30 PM - Break for Subcommittee to modify proposals as needed

- Board votes if ready

3:00 PM BREAK
USDA-AMS | National Organic Program

 National Organic Standards Board | Fall 2012 Meeting Agenda, Revised 10/03/2012

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Wednesday, October 1

7

3:15 PM Policy Development Subcommittee

Colehour Bondera, Chairperson

- Present Subcommittee proposals and summarize written comments 

Topics:

- Proposal: Conflict of Interest and Ethics 

- Proposal: Public Comment Procedures

- Proposal: Public Communications

4:00 PM - Public comments related to Policy Development Subcommittee 

4:45 PM - Break for Subcommittee to modify proposals as needed

- Board votes if ready

5:30 PM Recess
USDA-AMS | National Organic Program

 National Organic Standards Board | Fall 2012 Meeting Agenda, Revised 10/03/2012

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Thursday, October 1

8

8:00 AM Compliance, Accreditation and Certification Subcommittee 

Joe Dickson, Chairperson

- Present Subcommittee proposals and summarize written comments

Topics: 

- Discussion document: Calculating Percentage of Organic Ingredients

- Discussion document: Biodiversity update

8:30 AM - Public comments related to CAC Subcommittee 

8:50 AM Deferred Proposals/Final Votes

10:00 AM BREAK

10:15 AM Deferred Proposals/Final Votes

12:00 PM LUNCH 

1:00 PM Deferred Proposals/Final Votes

3:00 PM BREAK

3:15 PM NOSB Officer Elections 

3:30 PM Subcommittee Workplans

4:45 PM 

Other Business and Closing Remarks

- Farewell/presentation of plaque to Barry Flamm

5:00 PM Adjourn

National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Nonanoic acid

July 17, 2012

Summary of Proposed Action:

Nonanoic acid is a nine-carbon straight chain fatty acid which occurs at low levels in foods such 

as grapes, milk, oranges and apples. While there may be some non-synthetic sources of 

nonanoic acid, the petitioned material is a synthetic substance used as a topical insect repellent, 

with short term action requiring frequent treatment of livestock.

Nonanoic acid is an EPA registered fungicide and herbicide, and as such it does not appear on 

permitted substance lists in Canada, the European Union or Japan. There is potential for 

negative impact on the agro-ecosystem and soils. Further, there are a number of effective 

alternative treatments already available in addition to IPM and management practices. For these 

reasons the Livestock sub-committee is not recommending to add nonanoic acid to 205.603, 

insect repellent insecticide.

Evaluation Criteria 

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

(see “B” below)

1. Impact on Humans and Environment ☐ Yes X No ☐

N/A 

2. Essential & Availability Criteria ☐ Yes ☐X No 

☐ N/A

3. Compatibility & Consistency ☐ Yes ☐X 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: [ 3] Comments: 

Nonanoic acid is an EPA registered fungicide and herbicide that can be used as a weed killer 

and blossom thinner.

Proposed Annotation (if any): 

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

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state 

actual motion):

Classification Motion: Nonanoic acid (CAS112-05-0) as petitioned is synthetic

Motion by: Jean Richardson Seconded by: Colehour Bondera

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

Listing Motion: To add nonanoic acid (CAS 112-05-0) to 205.603, insect repellent, 

insecticide

9
Motion by: Jean Richardson Seconded by: Tracy Favre 

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

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock x☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic ☐x Rejected3 x☐

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: 4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

Wendy Fulwider, Committee Chair July 17, 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? 

Substance: Nonanoic Acid 

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 

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X 

The TR was not clear on this issue 

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X X 

The TR (lines 333-338) suggests 

that beneficial nematodes may be 

affected negatively by this substance

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 TR (lines 293-297) indicates 

potential wind drift impact on 

blossoms and weeds; 

TR (lines 333-338) concern over 

10
negative impact on nematodes in 

soil; lack of clarity on impact on 

beneficial nematodes and 

earthworms

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. Are there any harmful effects on 

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

c(2)(A)i; §6518 m.4]

X X TR (lines 383-385) indicates that the 

substance is an irritant, but was not 

evaluated for chronic toxicity.

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.

11
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? 

Substance: Nonanoic acid

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

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

3. Is the substance created by naturally 

occurring biological processes? [6502 

(21)]

X

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

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 TR (lines 398-400 and 413-414; 421-

441) indicates a wide range of natural 

substitute products.

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

10. Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

X TR (lines 446-515) describes systems 

of Integrated Pest Management (IPM)

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.

12
NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: Nonanoic acid

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X

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; 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.

13
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: Name Nonanoic acid

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

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 

X

14
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.

15
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Required Synthetic Amino Acids for Pet Foods

August 20, 2012

Summary of Proposed Action:

Thirteen synthetic amino acids were petitioned for use in organic pet foods. The 

Subcommittee evaluated the petition, TR, had discussion with State Feed Control 

Officials and concluded that only Taurine for cats was deemed necessary as a synthetic 

addative and thus allowed. It was determined that the manufacturers could meet the 

required levels of Arginine, DL-Methionine, Cysteine, L-Lysine, Tryptophan, Threonine, 

Histidine, Isoleucine, Leucine, Phenylalanine, Tyrosine, Valine to meet the criteria for 

“complete and balanced” as required by American Association of Feed Control Officials 

(AAFCO) with typical ingredients.

This petition checklist is only for Taurine for cats.

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: [ ] Comments: 

Proposed Annotation (if any): 205.603(e)(4) Taurine (CAS 107-35-7) for cats

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

Citation 

Notes: The other 12 petitioned Amino Acids failed to meet the necessity criteria

Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

16
Classification Motion: Motion to classify amino acids (Arginine, Methionine, 

Cystine, Lysine, Taurine, Tryptophan, Threonine, Histidine, Isoleucine, Leucine, 

Phenylalanine, Tyrosine, and Valine) as synthetic. 

Motion by: Mac Stone Seconded by: Colehour Bondera

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

Listing Motion: Motion to list amino acids (Arginine, Methionine, Cystine, Lysine, 

Taurine, Tryptophan, Threonine, Histidine, Isoleucine, Leucine, Phenylalanine, 

Tyrosine, and Valine) on section 205.603 on the National List for use in organic pet 

food.

Motion by: Mac Stone Seconded by: Colehour Bondera 

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

Listing Motion: Motion to list Taurine (CAS 107-35-7) on 206.603(e)(4) for cats

Motion by: Wendy Fulwider Seconded by: Calvin Walker 

Yes: # 7 No: # 0 Absent: # 1 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 § 205.603 with 

Annotation (if any): Taurine (CAS 107-35-7) on 206.603( e)(4) for cats

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: 12 petitioned items rejected for lack necessity to 

formulate complete and balanced feeds for cats and dogs 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

Wendy Fulwider, Committee Chair 8/16/12

17
NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? 

Substance: Taurine

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

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.Are there any harmful effects 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 

x

18
applicable Federal regulations? 

[205.600 b.3]

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.

NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? 

Substance: Taurine

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

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

3. Is the substance created 

by naturally occurring 

biological processes? 

[6502 (21)]

x

4. Is there a natural source 

of the substance? 

[§205.600 b.1]

x

5. Is there an organic 

substitute? [§205.600 

x

19
b.1]

6. Is the substance 

essential for handling of 

organically produced 

agricultural products? 

[§205.600 b.6]

X 

Taurine

Arginine, DLMethionine, 

Cysteine, LLysine, 

Tryptophan, 

Threonine, 

Histidine, 

Isoleucine, 

Leucine, 

Phenylalanine, 

Tyrosine, 

Valine

From the TAP and petition 

and discussions with Feed 

Control Officials, only 

Taurine was determined

absolutely necessary for 

cats, for diet formulators to 

meet AAFCO guidelines

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

10.Is there another practice 

that would make the 

substance unnecessary? 

[§6518 m.6]

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 Evaluation Criteria for Substances Added To the National List

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

Substance: Taurine

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

x

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

x

20
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; 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.

21
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: Name: Taurine

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

regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic 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:

a. Regions of production 

(including factors such as 

climate and number of 

regions);

X

22
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.

23
National Organic Standards Board

Livestock Subcommittee 

Discussion Document:Omnivore Diets

August 21, 2012

I. Introduction

The National Organic Standards Board (NOSB) Livestock Subcommittee (LS) seeks the 

organic community’s discussion on the framework for natural omnivore diet materials, 

production, manufacturing, and commercial availability. Pigs, chickens, and turkeys are 

omnivores. These omnivores eat primarily both plants and non-plant (meat) materials. 

Cattle, sheep, rabbits, and bison are herbivores. As herbivores, they eat primarily plant 

materials. The LS views the natural behavior of chickens, turkeys, and pigs to be 

omnivorous. Therefore, the LS is considering the options of providing both plants and 

animal materials that are compatible with organic principles, production practices, and 

that allow omnivores their natural diet of plant and animal materials rather than feeding 

an unnatural herbivore diet. The LS is seeking stakeholder input on the issue of an 

omnivorous diet for organically raised omnivores. 

 

II. Background

Chickens, turkeys, and pigs are omnivores. Omnivores, by nature, eat plant and nonplant materials. Organic production practices require that poultry and pigs be reared 

outdoors and on the soil. Because of this requirement, poultry and pigs should already 

be consuming plant and animal materials. These materials may include (1) grass and 

other plants, (2) insects and other invertebrates, (3) carrion, (4) vegetables, (5) fish or 

meat materials naturally, (6) herbs, (7) fruits, and (8) berries, nuts, and whatever else 

they find to eat. By foraging, the animals are performing their natural behavior in 

consuming a diverse diet that includes non-plant life. 

Practical poultry and swine diets fed for normal growth, maintenance, production, and 

reproduction require essential amino acids, minerals, vitamins, and possibly fatty acid 

supplementation. As the organic community moves toward reducing or removing 

synthetic supplements in omnivore diets, a real need exists for organic omnivore 

producers to provide or be provided options for supplying the essential nutrients to 

these omnivores. Essential nutrients are needed in poultry and pig diets due to their 

inability to manufacture certain nutrients in adequate amounts for maintenance, growth, 

reproduction, and production. While some organic practices, including access to biodiverse healthy pastures may provide some of these nutrients, supplementation may 

still be required. A case in point is methionine, an essential amino acid for poultry and 

pigs. Methionine comes in natural and synthetic forms. Methionine is naturally present 

in all feedstuffs with protein; however, the amount of methionine present varies among 

the various feedstuffs. Natural sources of methionine are corn gluten meal, crab meal, 

fishmeal, blood meal, alfalfa meal, and sunflower meal according to the NOP, (2012), 

Methionine Task Force, 2011, and NOP Technical Review of Methionine, 2011. There 

24
is at least one company that market sea kelp which is claimed to replace synthetic 

methionine There is an organic feed mill which manufactures a soy free feed mix using 

fishmeal for providing sufficient amino acids( methionine, lysine, etc.), mineral, vitamins 

( Favre, 2012). However, the mill manufactures medium to small formulations, primarily 

for small or hobby poultry producers. The cost and availability at a commercial level 

may be prohibitive. As it relates to fish meal, there seems to be an inadequate supply of 

fish meal with no synthetic preservatives added that would make fishmeal a possible 1:1 

replacement for synthetic methionine. There is interest in developing a natural source 

for methionine through extraction, fermentation or hydrolyzing protein, but at present, 

none of these processes currently provide a commercially viable alternative to synthetic 

methionine. (Fanatico, 2010). There is a potential herbal methionine on the market in 

India that might have applicability in the United States. Research results are promising 

and mixed. (Walker, 2012). Chattopadhyay, 2006 and Halder, G., and Roy, 2007 

reports a 1:1 replacement for synthetic methionine with herbal methionine in broiler 

rations. However, Salome, et.al. 2010 reported inferior results. The difference could be 

due to herbal ingredients in the natural methionine product. Salome, et. al. 2010 

suggested that the methionine requirement of broilers could be met by the 

supplementation of DL-Methionine and the use of animal protein sources. 

Synthetic methionine was first petitioned in 1995, with technical reviews in 1996, 1999, 

2001, and 2011. Currently, synthetic methionine is allowed in poultry diets at a 

maximum level of 4 pounds per ton of feed for layers, 5 pounds for broilers, and 6 

pounds for other poultry. From October 2, 2012 to October 1, 2017, the step-down rate 

will be 2 pounds for layers, 2 pounds for broilers, and 3 pounds for other poultry. 

Methionine will be up for a sunset review prior to 2017 and a new petition by the 

Methionine Working Group (MWG) has been submitted. Therefore, the LS is seeking to 

advise and assist in increasing the dialogue in the organic community on possible 

approaches to obtaining viable and commercially available natural methionine 

alternatives for poultry before the October 31, 2017 sunset date for synthetic 

methionine. 

Meat by-products and fish meals are good natural sources of essential minerals and 

vitamins. LS solicits our stakeholder input on possible ways to reduce synthetic 

nutrients (minerals, vitamins, and amino acids, etc.) in organic livestock rations by 

organic omnivore producers regardless to scale and type of operation. Significant work 

has been done on alternatives to synthetic methionine; yet more effort is still required. 

Time is of the essence. We believe that the current work into researching natural forms 

of methionine is encouraging. However, it needs to be accelerated. It could be that not 

one, but multiple organic practices may be required in order to provide a viable 

alternative to synthetic methionine. 

25
III. Relevant Areas of the Rule

Relevant areas of the rules are briefly stated in this section. At Section 2110(3) of the 

Organic Foods Production act (OFPA) it reads, “.... no use of growth promoters and 

hormones on such livestock, whether implanted, ingested, or injected, including

antibiotics and synthetic trace elements used to stimulate growth or production of such 

livestock.” The National Organic Program regulatory text at 205.239 (a) states, “the 

producer of an organic livestock operation must establish and maintain livestock living 

conditions which accommodate the health and natural behavior of animals.” The rule

at §205.239(a) (1) further asserts that “access to the outdoors, shade, shelter, exercise 

areas, fresh air, and the environment are required.” At §205.238(a)(2), it reads, 

“provision of a feed ration sufficient to meet nutritional requirements, including vitamins, 

minerals, protein and/or amino acids, fatty acids, energy sources, and fiber (ruminants)” 

is required. 

At § 205.237 Livestock feed.

(a) The producer of an organic livestock operation must provide livestock with a total 

feed ration composed of agricultural products, including pasture and forage, that are

organically produced and, if applicable, organically handled: Except, That, non-synthetic 

substances and synthetic substances allowed under §205.603 may be used as feed 

additives and supplements, (b) the producer of an organic operation must not: (1) use

animal drugs, including hormones, to promote growth; (2) provide feed supplements or 

additives in amounts above those needed for adequate nutrition and health 

maintenance for the species at its specific stage of life; (3) feed plastic pellets for 

roughage; (4) Feed formulas containing urea or manure; 

(5) feed mammalian or poultry slaughter by-products to mammals or poultry; or (6) use 

feed, feed additives, and feed supplements in violation of the Federal Food, Drug, and 

Cosmetic Act.(OFPA, 2002). 

 

IV. Discussion

Prior to the 1950’s poultry and pigs were fed a plant and meat based diet without 

synthetic amino acids such as methionine. One former NOSB member stated, “we have 

seemingly made vegetarians out of poultry and pigs” in §205.237(5) (b). As the organic 

community moves toward reducing or removing synthetic nutrients in the diets of 

poultry, a heightened need exists for the organic community to rally around omnivore 

producers to marshal our collective efforts in finding viable alternatives to synthetic 

methionine, and to help find approaches for making them more commercially available. 

The approaches need to be compatible with (1) omnivore natural behavior and food 

sources, (2) organic principles, and (3) good organic omnivore management practices.

26
To enhance our ability to consider and incorporate public comment into our decisionmaking process, the LS is seeking public input on this topic as a means of addressing 

this important concern. In particular, the LS seeks input regarding solutions to low 

supply of materials, commercial availability, approaches for providing a greater 

opportunity for the expression of an animal’s natural behavior and providing a path for 

nutritional management of omnivores as omnivores rather than feeding a natural 

omnivore as a vegetarian or herbivore. 

V. Discussion Questions Request from Stakeholders 

The LS is seeking the public’s perspective on the questions below. (Please indicate the 

question number in responses provided to these questions below.) 

1. Would you recommend the LS look at a possible annotation to allow 100% 

organic meat scraps or by-products to be used in omnivore diets (poultry and 

pigs), since it is natural for these omnivores to consume both plant and animals 

materials? Explain. 

2. Natural herbal methionine, potato meal, and corn gluten meal are showing 

promising results. Should this type of research effort increase? Explain. 

3. There is a natural herbal methionine manufacturer in India that touts their product 

as being a 1:1 replacement for synthetic methionine. How can this product be

brought to commercial availability/viability within the next three years in the 

United States?

4. How can the organic community spur more production and manufacturing of 

natural amino acids, including methionine and lysine, vitamins, and minerals 

products for livestock and aquaculture rations in the next three to five years? 

5. While the FDA regulates the safety of meat/slaughter by-products, what 

additional organic regulations or safeguards should be in place before organic 

livestock producers feed mammalian or avian slaughter by-products to their 

omnivore livestock? 

6. Would the organic brand be damaged if organic livestock producers were given 

the choice of feeding organic animal by-products and naturally or organically 

harvested fish by-products? Explain. 

7. Would a rule change at §205.237(5) (b) to allow the feeding of organic meat offal 

or by-products to omnivores be appropriate to help fulfill the essential amino 

acids, vitamins, and minerals requirement? If yes, state the language you would 

use. If no, offer viable suggestions to dealing with the absence of synthetic amino 

acids in omnivore rations. 

27
VII. References

Chattopadhyay, K., M.K. Mondal, and B. Roy. 2006. Comparative efficacy of GLMethionine and herbal methionine on performance of broiler chicken. International 

Journal of Poultry Science 5(11): 1034-1039. Retrieved August 14, 2012 from 

http://docsdrive.com/pdfs/ansinet/ijps/2006/1034-1039.pdf

Fanatico, A. 2010. Organic poultry production: Providing adequate methionine. A 

publication of ATTERA, National Sustainable Agriculture Information service. Retrieved 

July 8, 2011 from http://attra.ncat.org/attra-pub/methionine.html

Favre, T. 2012. Personal Communication with K. Fletcher, Countryside natural products 

Federal Register. 2012. National Organic Program; proposed amendment to the 

national list of allowed and prohibited substances (Livestock), federal register, Vol. 77, 

No. 24.

Halder, G., and Roy, B. 2007. Effect of herbal or synthetic methionine on performance, 

cost benefits ratio, meat and feather quality of broiler chicken. International Journal of 

Agricultural Research 2(12):987-996. Retrieved August 14, 2012 from 

http://scialert.net/fulltext/?doi=ijar.2007.987.996

Methionine Task Force, 2011. Methionine task force update. 2011. Paper presented at 

the National Organic Standard Board, November, 28, 2011, Savannah, Georgia.

Organic Food Production Act. 2002. Livestock feed. Retrieved August 14, 2012 from

http://law.justia.com/cfr/title07/7-3.1.1.9.31.3.34.11.html.

Salome, I., I.I. Dafwag, and G.S. Bawa. 2010. Evaluation of methiorep as a substitute 

for methionine in broiler diets. International Journal of Poultry Science 9(8): 809-812. 

Retrieved August 14, 2012 from http://www.pjbs.org/ijps/fin1776.pdf

Technical Evaluation Report, 2011. Methionine. ICF International for USDA National 

Organic Program 2011.

VIII. Summary

Poultry and pigs are omnivores and naturally eat plant, animal, and non-animal 

materials. Yet in organic livestock production, they are fed as vegetarians and 

herbivores. Maybe it is time to feed organic materials that are of both plant and animal 

origin. 

IX. Committee Vote:

Moved: Tracy Favre Second: Jean Richardson

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recusals: 0

28
National Organic Standards Board 

GMO Ad hoc Subcommittee 

Discussion Document

GMOs and Seed Purity

August 17, 2012

Introduction

Organic stakeholders are concerned about keeping genetically modified organisms (GMOs) 

(i.e., the products of transgenic plant or animal breeding) out of organic livestock feed, crops, 

and food. The production and handling of organic goods prohibits the use of “excluded 

methods” including transgenic modification. This prohibition applies to seeds used on organic 

farms. The organic community continues to be proactive in developing positions, procedures, 

and practices to encourage GMO prevention. An important part of this is ensuring genetic 

purity of seed used on organic farms. Pure seed is a cornerstone of true sustainability in an 

organic farming system.

Policy Memo 11-13 from the National Organic Program (NOP) affirms that organic certification 

is process based. The public comments to National Organic Standards Board (NOSB) and 

NOP continue to indicate a strong concern by both producers and consumers of organic foods

for stronger steps to limit the potential and/or unintended presence of GMOs. 

In 2012, the NOSB established the GMO Ad hoc Subcommittee. In this discussion document, 

the sub-committee seeks the input from organic stakeholders on the possibly of strengthening 

seed purity as one step to avoid the potential contamination of crops with GMOs. Seed may 

be the most impactful and efficient point in the supply chain at which GMO contamination of 

organic feed, crops, and food could be limited and controlled. This suggestion implies that 

recommending standards for the genetic content of seeds used in organic production would be 

an appropriate point of focus for NOSB. 

Background 

• The NOP Organic Rule refers to Genetic Engineering (GE) as an "excluded method". 

“Organic” is a label that indicates that a process has been followed to exclude GMOs. 

• Producing organic feed, crops, and food ‘free’ of GMOs requires starting with seed that 

is not contaminated by GMOs. 

• Public and marketplace expectations for the absence of GMOs in organic goods call for 

implementing best practices on conventional and organic farms to minimize the 

potential for such contamination.

• We suggest that the process for ensuring genetic purity of commercial seeds in organic 

production must be stricter than conventional crop production. Clean seed must be 

planted for the farmer to harvest uncontaminated food or feed. Planting and harvesting 

contaminated seed can increase the likelihood of “creeping contamination” from year to 

year, since any additional GE drift into a field planted with partially contaminated seed 

would produce food, crops, or feed with a higher level of contamination than in the 

original seed. 

29
• Genetic purity in seed cannot be addressed by field observations of various visual offtypes as has been practiced by the seed industry in the past. Genetic purity must also 

now encompass the presence or absence of GE contamination, with the protocols for 

making such a determination structured to meet the concerns and demands in the 

marketplace.

Relevant Areas of the Rule

NOP standards1 adopted by USDA in a final rule published in December 2000 and 

fully implemented in October 2002 prohibited the use of GMOs in the production and 

handling of organic products certified to national organic standards.

The terminology used for GMOs in the NOP Regulation is “excluded methods” and is 

specified under section 205.2 (Terms Defined) as:

Excluded methods. A variety of methods used to genetically modify 

organisms or influence their growth and development by means that are not 

possible under natural conditions or processes and are not considered 

compatible with organic production. Such methods include cell fusion, 

microencapsulation and macroencapsulation, and recombinant DNA 

technology (including gene deletion, gene doubling, introducing a foreign 

gene, and changing the positions of genes when achieved by recombinant 

DNA technology). Excluded methods do not include the use of traditional 

breeding, conjugation, fermentation, hybridization, in vitro fertilization, or 

tissue culture.

Detection and Testing Requirements: Under the residue testing requirements of NOP, 

products from certified organic operations may require testing when there is reason to 

believe that certified products have come into contact with prohibited substances or 

have been produced using excluded methods. 

This requirement is specified in Subpart G (Administrative) of the regulations:

§ 205.670 Inspection and testing of agricultural product to be sold or 

labeled “organic.”

(b) The Administrator, applicable State organic program's governing State 

official, or the certifying agent may require pre-harvest or post-harvest testing of 

any agricultural input used or agricultural product to be sold, labeled, or 

represented as “100 percent organic,” “organic,” or “made with organic 

(specified ingredients or food group(s))” when there is reason to believe that the 

agricultural input or product has come into contact with a prohibited substance 

or has been produced using excluded methods. Such tests must be conducted 

by the applicable State organic program's governing State official or the 

certifying agent at the official's or certifying agent's own expense.

1 Title 7 CFR Part 205 - National Organic Program 

30
NOP Policy: The NOP finalized a Policy Memo on July 22, 2011 (Policy Memo 11-13) 

on GMO. This policy memo reiterates that the use of GMOs is prohibited under NOP 

regulations, and answer questions that have been raised concerning GMOs, organic 

production, and handling. The clarification provided is consistent with the explanations 

provided in the preamble, thus emphasizing that organic certification is a process-based 

standard and the presence of detectable GMO residue alone does not necessarily 

constitute a violation of the regulation. 

Commercial Availability of Organic Seed: The NOP regulations at 7 CFR § 205.204 

require that organic producers use organic seeds, annual seedlings, and planting stock. 

The regulations allow producers to utilize non-organic seeds and annual or perennial 

planting stock when organic varieties are not commercially available. 

The term “commercial availability” is defined under section 205.2 (Terms Defined) as:

The ability to obtain a production input in an appropriate form, quality, or quantity to 

fulfill an essential function in a system of organic production or handling, as determined 

by the certifying agent in the course of reviewing the organic plan.

Discussion

1. Currently the organic standards require that seed used in organic production not be 

produced using excluded methods; and the marketplace is increasingly sensitive to 

contamination of organic crops by GMOs yet no standard or system exists to determine 

that the foundation of the value chain – seed - is free of GMOs. 

2. The private sector has a variety of requirements and standards related to quantification 

of genetic materials (GM) content yet most of that data is not accessible to an 

accredited certifying agent and, therefore, is not currently helpful in terms of oversight 

and compliance. If it were available, there is no protocol within the organic sector for 

evaluating and using the testing results. 

3. Farmers growing seed are increasingly being required to test for GMOs by their buyers

in an ad hoc manner. Buyers may have different test protocols and evaluation of results

which makes it difficult to compare and use the information. 

4. Securing a supply of GMO free seed is critical to the long-term ability of organic to meet 

consumers’ expectation of organic vis-a-vis GMOs.

5. Current NOP policy doesn’t require verification that seed is free of GMO. However, if 

someone desires to have as thorough a process as possible to exclude GMOs, they 

may want to address their seed purity to the extent possible.

6. Despite the distinction between “excluded methods are not used” and “no traces of 

GMOs are present,” the expectations of some consumers confuse these claims (and 

some marketers encourage this confusion).

31
7. The NOSB may consider in the future a universal genetic purity standard for seed to be 

used in organic production systems. An example of the standard would be the 

presence or absence of GE content, and the standard is equally applicable to 

conventional and organic seed. For example- no GE seeds found in a 3,000 seed 

sample. “None found” in a 3,000 seed sample corresponds statistically to a 95% 

probability that the actual GE contamination level in the seed lot is between zero 

percent and 0.10%. The use of terms like “non-detect” or” none found in the sample” is 

consistent with this goal, and less confusing than the statistical expression summarizing 

what “none found” in a sample means relative to the level of certainty that the whole lot 

is not contaminated.

8. The need to use organically grown seed is affected by the need for commercially 

available GMO tested seed to satisfy buyers. Farmers are challenged to balance 

prevention of GMO with adherence to the guidance on organic seed.

Discussion Questions

The GMO ad-hoc subcommittee is seeking response from the organic community to several 

questions regarding seed purity as follow:

1. Is there a need to establish a seed purity standard or protocol to ensure that planting 

seed meets the requirements of the NOP rule? Explain your answer. 

2. What is currently known about the level of GMO contamination of seed used by organic 

farmers and any associated testing of seed on the farm or in the supply chain? 

Comments from farmers, seed companies, or buyers describing the following would be 

relevant: 

• the scope of testing (e.g. frequency, methods, costs); 

• the threshold used for rejection; and 

• the outcome of seeds that are rejected.

3. What testing methods are appropriate to use in order to determine and label for seed 

purity and to verify compliance to a seed purity standard? 

4. How would an example such as proposed in Discussion point #7 above affect your farm 

or business?

5. Is there a better suggestion for a seed purity standard than that proposed in Discussion 

point #7 above? Describe. 

6. What is known about relevant sampling, testing, and detection level protocol necessary 

to implement such a standard?

7. What training, guidance, or resources do certifiers need to verify compliance for to a 

seed purity standard?

8. What approach could an organic seed producers used to safeguard against GMO 

contamination from an adjacent or neighboring conventional farm? Buffer zones, 

32
distance, planting time, pollination factors, and contamination possibilities/solutions 

could be included in your response. 

 

Subcommittee Vote:

Motion to adopt the proposed Discussion Document on GMOs and Seed Purity.

Moved: Zea Sonnabend Second: Calvin Walker

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

33
34
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Biodegradable Mulch Film Made from Bioplastics

August 15, 2012

Introduction

A petition was submitted requesting the addition of biodegradable biobased bioplastic mulch to 

section 205.601(h) of the National List. This petition involves definitions of new substances, 

which the subcommittee recommends be incorporated into the listing. The subcommittee 

explicitly seeks public comment on the definitions and possible restrictions on use.

Background

Biodegradable mulch film made from bioplastics is petitioned to section 205.601 of the 

National List for use in organic crop production. This is an alternative to petroleum-based 

plastic mulches that do not completely biodegrade. Over the past 50 years much research and 

development has gone into developing biodegradable mulches which are the subject of this 

petition. As product development has been underway, removal and disposal of polyethylene 

plastic mulches has become increasingly difficult because its removal is time-consuming, 

delays cover cropping and must largely be sent to landfills. The OFPA requires the removal of 

plastic mulches at the end of the growing or harvest season (7 U.S.C. 6508). 

The petitioner argues that OFPA’s mention of plastic was not intended to refer to 

biodegradable mulch film. Biodegradable mulch is intended to biodegrade by the end of the 

season or prior to the beginning of the following season. This distinction leads us to question 

whether the approval of the petition would require a rule change to allow the mulch to 

biodegrade in the field or whether the two substances should be treated as separate and

distinct. However, bioplastics are defined in terms of “plastics,” according to the petitioner, 

“Biodegradable Plastic Mulch is defined as plastic mulching material that meets both of the 

following requirements.” Furthermore, bioplastics fit the definition of plastic, “Any of various 

organic compounds produced by polymerization, capable of being molded, extruded, cast into 

various shapes and films, or drawn into filaments used as textile fibers.” (American Heritage 

Dictionary) The petition defines biodegradable mulch film as mulching materials that:

1) meet the requirements of ASTM International (formerly American Society for Texting 

and Materials) Standard D6400 or D6868 specifications, or of other international 

standard specifications with essentially identical criteria, i.e. EN 13432, EN 14995, 

ISO 17088; and

2) show at least 90% biodegradation absolute or relative to microcrystalline cellulose2 

in less than two years, in soil, tested according to ISO 17556 or ASTM 5988.

Additionally, the petitioner suggests that the reference to “fully biodegradable” in section 

205.206(c)(1) be defined when referencing bioplastic degradation in soil. Full biodegradation is 

covered under several standards which discuss the compostability of the petitioned product. 

These include, American Society for Testing and Materials (ASTM) Standard D5988 

(biodegradability of bioplastic in soil), ASTM Standard D6400 (biodegradability of bioplastic in 

compost), and ASTM Standard D6868 (biodegradability of bioplastic specifications). The 

35
ASTM definition of “biodegradable plastic” is, “a degradable plastic in which the degradation 

results from the action of naturally occurring microorganisms such as bacteria, fungi, and 

algae.”

The petition further clarifies, that according to the European Bioplastics’ definition, bioplastics 

are biobased, biodegradable, or both. The ASTM definition of “biobased material” is “organic 

material in which carbon is derived from a renewable resource via biological processes. 

Biobased materials include all plant and animal mass derived from carbon dioxide recently 

fixed via photosynthesis, per definition of a renewable resource.” Biobased materials are 

certified using the ASTM D6866 method, which certifies the biologically derived content of 

bioplastics. 

The petition provides the following description: biodegradable films are produced from 

bioplastics that meet standards for aerobic biodegradation in soil. These bioplastics are 

comprised of structural units which may be easily broken down into carbon substrates by soil 

microorganisms. Under aerobic conditions, these microorganisms are able to utilize the carbon 

substrates as a food source. This metabolism of the carbon substrates ultimately results in two 

simple compounds – carbon dioxide and water.

Relevant areas in the Rule

OFPA §6508 (c) says

For a farm to be certified under this chapter, producers on such farm shall not - 

...(2) use plastic mulches, unless such mulches are removed at the end of each 

growing or harvest season;

The regulations provide at §205.206(c) that 

Weed problems may be controlled through:

... (6) Plastic or other synthetic mulches: Provided, That, they are removed from the 

field at the end of the growing or harvest season.

And the National List includes at §205.601(b)(2)

Mulches.

...(ii) Plastic mulch and covers (petroleum-based other than polyvinyl chloride (PVC)).

Discussion 

Neither conventional plastic mulch nor biodegradable bioplastic mulch can perform all of the 

functions—particularly, feeding the soil—that organic mulches perform. However, there are 

times—such as when cold soil is a problem—when the qualities of plastic or bioplastic have 

been viewed as necessary. As always, it is our understanding that the use of synthetic mulch 

products will be limited to those circumstances when natural organic mulches are inappropriate 

or impossible to use. When this is the case, it makes sense to use a material that degrades in 

place rather than one that is removed and taken to a landfill. On the other hand, the 

subcommittee believes that it may be difficult to separate claims from truth concerning 

biodegradability and the source of the material. In addition, the subcommittee would like to 

make a robust recommendation that correctly describes biodegradable biobased bioplastic 

mulches that meet the three criteria above. According to the European Bioplastics definition, 

bioplastics are biobased, biodegradable, or both. The committee intends this recommendation 

to cover those bioplastics that are both biobased and biodegradable.

36
The subcommittee understands the importance of a definition, which it is proposing, and is 

particularly interested in public comment on the biobased classification and the ASTM 

standard. Meeting this standard, however, does not automatically ensure that the mulch will be 

“removed from the field at the end of each growing or harvest season.” This removal may 

require steps like tilling the film into the ground. The subcommittee therefore proposes the 

annotation that growers take appropriate actions to guarantee that the mulch decomposes 

within the appropriate time frame.

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: [ ] Comments:

Proposed Annotation: 

List on §205.601(b)(2) Mulches: (iii) Biodegradable biobased bioplastic mulch meeting the 

following criteria: (A) Completely biodegradable as shown by: 1) meeting the requirements of 

ASTM Standard D6400 or D6868 specifications, or of other international standard 

specifications with essentially identical criteria, i.e. EN 13432, EN 14995, ISO 17088; and 2) 

showing at least 90% biodegradation absolute or relative to microcrystalline cellulose in less 

than two years, in soil, tested according to ISO 17556 or ASTM 5988; (B) Biobased certified 

using the ASTM D6866 method; (C) Must be produced without excluded methods; (D) Must be 

produced without engineered nanomaterials; and (E) Grower must take appropriate actions to 

ensure complete degradation at the end of each growing or harvest season. 

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

Notes: Annotation is necessary to meet the requirements of OFPA §6508(c).

Recommended Subcommittee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: 

Biodegradable Mulch Film Made from Bioplastics is synthetic.

Motion by: Colehour Bondera Seconded by: Jay Feldman

Yes__8___ No__0__ Abstain__0__ Recuse__0__ Absent__0__

Listing Motion: 

To list on §205.601(b)(2) Mulches: (iii) Biodegradable biobased bioplastic mulch meeting 

the following criteria: (A) Completely biodegradable as shown by: 1) meeting the 

requirements of ASTM Standard D6400 or D6868 specifications, or of other international 

standard specifications with essentially identical criteria, i.e. EN 13432, EN 14995, ISO 

17088; and 2) showing at least 90% biodegradation absolute or relative to microcrystalline 

37
cellulose in less than two years, in soil, tested according to ISO 17556 or ASTM 5988; (B) 

Biobased certified using the ASTM D6866 method; (C) Must be produced without excluded 

methods; (D) Must be produced without engineered nanomaterials; and (E) Grower must 

take appropriate actions to ensure complete degradation at the end of each growing or 

harvest season.

Motion by: Colehour Bondera Seconded by: Barry Flamm

Yes__7___ No__0__ Abstain__1__ Recuse__0__ Absent__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 § 20 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: 

4

Substance was recommended to be deferred because 

 

If follow-up needed, who will follow up: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 15, 2012

NOSB Evaluation Criteria for Substances Added To the National List

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

 Mulch Film Made from Bioplastics 

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 TER 525-531: The production of PLA 

& PHA involves fermentation 

processes & feedstocks derived from 

natural sources (with the exception of 

genetically-modified organisms). The 

potential for environmental 

38
contamination from these products is 

limited, with the exception of the 

metal salt catalysts used to 

polymerize PLA (Bastioli, 2005). No 

reports of tin contamination from 

production of bioplastics were found.

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

x TER 533-537: Many of the feedstocks 

used in the production of AAC could 

be hazardous if they were spilled or 

discharged into the environment 

during manufacture & processing. No 

specific reports of environmental 

contamination from these compounds 

as a result of manufacturing 

bioplastics were found. Systematic 

reviews of the environmental impact 

from manufacturing of bioplastics 

were not found. TER 547-550: 

Erucamide, glycerol, & searic acid 

amide could be released to the 

environment through multiple 

manufacturing processes, including 

bioplastics production. No research 

reports were found that described 

environmental releases of these 

chemicals from bioplastics 

manufacturing.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x TER 614-621: The researchers 

concluded that using PE mulch may 

have a harmful effect on the 

environment due to increased runoff 

& is less sustainable than vegetative 

mulch (Rice et al., 2001). Based on 

their similarities in construction & 

intended use, bioplastic mulches 

would likely have similar 

environmental impacts to PE mulch, 

though their greater tendency to 

degrade sooner than PE mulch may 

decrease some of the adverse 

environmental impacts. TER 623-627: 

Anaerobic degradation of bioplastics 

may produce methane (greenhouse 

gas). Research was not found that 

quantified methane emissions from 

bioplastic mulch use. Degradation of 

bioplastic mulches must take place in 

an aerobic environment in the soil to 

prevent methane emissions. TER 

39
62

9-630: Adverse environmental 

impacts from the use of bioplastic 

mulches are only likely to occur if the 

material does not completely 

biodegrade in soil. TER 652-657: 

Some reports have shown that 

bioplastics containing terephthalic 

acid at concentrations over 50% do 

not completely biodegrade in soil 

(Bastioli, 2005). 

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 TER 566-567: The plastics are inert in 

the soil when they are intact, and are 

biodegraded by soil microorganisms.

6. Are there adverse biological and 

chemical interactions in agro-

ecosystem? [§6518 m.5]

x TER 582-587: Given the complete 

aerobic biodegradation of bioplastic 

mulches, the by-products are carbon 

dioxide, water, & soil biomass. Soil 

biomass refers to the total amount of 

microorganisms in the soil, excluding 

plant roots & macrofauna (NRCS, 

2012). The increase in biomass may 

cause a concomitant increase in the 

populations of microorganisms that 

degrade the mulches on a local basis. 

This could lead to changes in the 

population dynamics of 

microorganisms in the soil. TER 593-

595: Complete degradation of the 

bioplastics depends on blending the 

polymers to maximize degradability & 

depends on the composition of soil 

microorganisms. 

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

x TER 352-354 ASTM standard D5988 

is designed to be applicable to 

bioplastic materials that are “not 

inhibitory to the bacteria & fungi 

present in the soil”...it could be 

assumed that the bioplastic does not 

inhibit soil bacteria or fungi by its 

breakdown processes. TER 357-358: 

Many bacteria & fungi in the soil can 

use bioplastics derived from starch as 

a carbon source (Shah et al., 2008).

TER 409-410: Biochar, a method of 

generating carbon black for soil 

40
amendment, may help promote 

nutrient use efficiency in treated soils 

(Chan, 2008; Hunt, 2010).

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518 m.2]

x TER 446-447: Studies were not found 

that specifically assessed the 

ecotoxicity of bioplastics following 

degradation in the soil, & a better 

understanding of bioplastic 

degradation & soil environmental 

effects is needed. TER 462-466: It 

seems unlikely that the source 

material (the bioplastic film) would 

interact with other organisms & cause 

toxicity. The material is manufactured 

to remain intact & inert during its 

intended use, then (ideally) break 

down at the end of the season.

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment?

[§6518 m.2]

x x TER 330-333: The petitioner states 

that biodegradable mulch film is 

defined in two ways...Second, by

“show[ing] at least 90% 

biodegradation absolute or relative to 

microcrystalline cellulose in less than 

two years, in soil, tested according to 

ISO 17556 or ASTM 5988.” TER 347-

350: ISO 17556 & ASTM 5988 are 

equivalent standards. They “describe 

the standard test method for 

determining aerobic biodegradation of 

plastic materials in soil.” This 

standard is most applicable to the 

proposed use of the bioplastic mulch 

because the mulches will be left in the 

field at the end of the season to 

biodegrade according to their 

petitioned use. TER 356-357: 

Biodegradability is quantified by 

measuring the amount of carbon 

dioxide released from the soil over 

time. TER 362-370: degradation 

occurs quicker when chiseled or tilled 

into the soil during times of warm 

temperatures & moisture in soils with 

high organic matter. TER 374-375: 

Hydrolysis breaks PLA into lactic acid 

& water-soluble compounds. Once 

this breakdown occurs, PLA is 

completely mineralized to CO2, water, 

& biomass. TER 384-386: 

41
Degradation of PHA occurs by 

enzymatic hydrolysis at the surface of 

the film, which is carried out by soil 

microbial populations. Hydrolysis 

breaks the PHA polymers into 

oligomers & monomers which are 

subsequently consumed & 

assimilated by microbes in the soil as 

nutrients. TER 395-399: All of the 

commercially available AAC polymer 

materials contain terephthalic acid, 

which is most responsible for 

determining the degradation rates in 

AAC plastics. As the fraction of 

terephthalic acid increases, the 

degradation rate decreases. No 

significant biological degradation was 

found when the molar fraction of AAC 

was increased to more than 60%, 

which is thought to be due to the 

relatively low melting point of 

terephthalic acid (Bastioli, 2005). TER 

405-410: Carbon black is elemental 

carbon in the form of a particulate that 

is manufactured from burning or 

partial combustion of hydrocarbons 

(NLM, 2011)...it is resistant to 

breakdown in the soil environment.

TER 412-419: Titanium dioxide is 

found as the minerals rutile, 

octahedrite, brookite, ilmenite, & 

perovskite. Titanium dioxide may 

persist in soil as the by-product of 

titanium tetrachloride hydrolysis 

(ATSDR, 1997), so it may persist from 

use in bioplastic mulch as well. 

Titanium dioxide may settle out into 

sediments & persist for long periods 

of time (ATSDR, 1997). The 

compound is characterized by 

ATSDR as “ a very inert compound” 

(ATSDR, 1997). TER 421-425: 

Erucamide (plasticizer) binds strongly 

to soil & sediments in water & is likely 

to bioconcentrate in aquatic 

organisms, meaning it will occur at 

higher levels up the food chain (NLM, 

2011). The physical properties of 

erucamide suggest that the material 

42
will persist in the environment, and 

would be found in the water, soil & air 

if released (NLM, 2011). TER 427-

431: Glycerol (plasticizer) released to

the environment will be present as 

both a vapor & a particle in the 

atmosphere, but will be degraded 

within hours (NLM, 2011). The 

potential for bioconcentration in 

aquatic organisms is low for glycerol 

in aquatic environments (NLM, 2011).

10.Are there any harmful effects on 

human health? [§6517 c (1)(A)(i); 

6517 c(2)(A)i; §6518 m.4]

x TER 663-673: Pesticide runoff may 

be increased if plastic mulches are 

used in agricultural production due to 

the creation of impervious surfaces 

(Rice et al., 2001). The increase in 

pesticide loads may lead to an overall 

increase in the pesticide load in 

waterways which could potentially 

impact human health by causing 

increases in pesticide loads in 

downstream drinking water sources. 

No other reports of impacts on human 

health from the use of bioplastic 

mulches were found in the published 

literature.

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.

43
NOSB Evaluation Criteria for Substances Added To the National List

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

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 TER 294-296: Bioplastic mulches are 

manufactured with the addition of 

synthetic plasticizers and colorants 

which are added using a synthetic 

process. 

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 TER 301-302: To develop PLA the 

lactic acid monomers must be 

polymerized. This is accomplished 

through the use of a chemical 

catalyst. TER 302-305: Fermentation 

is a naturally occurring process, but 

under laboratory conditions, the 

feedstocks and environmental 

conditions are manipulated in order to 

provide an environment that is most 

conducive to production of PLA, a 

process which would be unlikely to 

occur in nature. TER 309-310: 

Researchers have developed 

genetically-engineered bacterial 

strains that produce PHA more 

efficiently & in differing polymer 

amounts. TER 313-315: PHA 

production by fermentation is a 

natural process, but the conditions 

used in laboratories to maximize 

yields and polymer amounts are not 

naturally occurring. TER 317-319: 

Some feedstocks used to produce 

AAC are naturally occurring, but the 

chemical processes used to refine 

them for use do not occur in nature, 

nor do the synthetic processes that 

are used to create the ester linkages.

3. Is the substance created by naturally 

occurring biological processes? 

[6502 (21)]

x x

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

6. Is the substance essential for x

44
handling of organically produced 

agricultural products? [§205.600 b.6]

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

x TER 679-682: The petitioned 

substance would be an alternative to 

synthetic, non-degradable substance, 

polyethylene plastic mulch. Bioplastic 

mulch is produced through synthetic 

processes as previously described, 

but is created to be biodegradable, a 

reason for its petitioned use in organic 

agriculture. TER 684-690: Mulches 

made from biomass include bark, 

cocoa-bean hulls, corncobs, grass 

clippings, leaves, pine needles, 

sawdust, straw, & wood chips. 

Biomass mulch availability may 

depend on what types of plants or 

crops are available in the area & the 

type of crop they are used in.

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 TER 717-721: Living mulch involves 

planting a low-growing cover crop that 

is effective at competing with weed 

species. The drawback is that living 

mulches compete for nutrients & 

water & reduce yields. Reports 

discuss the need to strike a balance 

between environmental impact, cost,

ease of use, & crop yields to 

determine which alternative is most 

beneficial for individual farms & crops.

10.Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

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.

45
NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: 

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

x

2. Is the substance consistent with 

organic farming and handling? [§6517 

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

x x The substance is of synthetic origin 

but appears to completely biodegrade 

in a two-year timeframe. This serves 

as an alternative to the current 

practice of using synthetic, nondegradable, polyethylene plastic 

mulch.

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; 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 TER 218- 221: Bioplastic mulch is 

used as a production aid, but is not 

technically considered a row cover 

because they increase soil 

temperature, reduce weed pressure, 

maintain soil moisture levels, and may 

46
help extend the growing season.

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.

47
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: Name

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

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

48
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.

49
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Ferric Phosphate (to Remove)

August 15, 2012

Introduction: 

Ferric Phosphate has been petitioned to be removed from the National List 205.601(h). The 

reason given in the petition is that it cannot be used without EDTA, which according to the EPA 

can either be considered an active ingredient or an inert ingredient.

 

Background: 

In 2007 the NOSB considered a petition for “Sodium Ferric Hydroxyl EDTA” aka “Ferric 

Sodium EDTA” and voted not to allow it, partly because of concern about the EDTA 

component. In 2008 and 2009 Steptoe & Johnson Law Firm submitted a petition to delist Ferric 

Phosphate. The main argument was that it does not work by itself and is always used with 

EDTA. The Technical Report (TR) requested in 2009 was received in June 2010. From 2009 to 

2011 the Walter Talarek Law Firm submitted voluminous amounts of written comment in 

defense of keeping Ferric Phosphate listed. Much of the data submitted with this comment was 

not considered in the TR and needed to be reviewed objectively.

These two law firms represent competing product manufacturers and each is accusing the 

other of misrepresenting their data. Therefore the NOSB is having a big challenge in 

determining the truth among all the arguments. The Crops Subcommittee requested an 

unbiased review of a few specific and targeted questions of all available information, including 

the TR, the public comment from the last 2 years, and independent sources.

Relevant areas in the Rule: 

The National List includes at: 

§205.601(h) 

As slug or snail bait. Ferric phosphate (CAS # 10045–86–0).

and

§205.601(m)(1)

(1) EPA List 4—Inerts of Minimal Concern.

Discussion: 

The Supplemental TR (STR) received in July 2012 addressed the following questions and 

provided the following answers. At the request of the NOP, the USDA Agricultural Research 

Service (ARS) reviewed the STR; ARS citations follow below.

1. Is ferric phosphate alone an effective molluscicide? Can it be combined with other 

ingredients besides EDTA and still work, or are EDTA and related compounds the only 

ones that contribute to efficacy? 

• STR 66-69: Effective bait formulations have been made by combining a metal with “an 

appropriate organic ligand” to form a metal chelate, [1] for example aluminum and iron 

chelates (Henderson and Triebskorn, 2002). The compound EDTA is one example of a 

chelating agent, and it appears that all of the ferric phosphate slug and snail baits 

currently marketed in the U.S. contain EDTA in their formulations. 

50
• STR 182-187: Based on the available studies (summarized in Table 1), there is not 

enough evidence to definitively conclude that ferric phosphate alone is an effective 

molluscicide when incorporated into ingestible baits. The limited evidence does support 

the conclusion that iron baits that contain a chelating agent such as EDTA are typically 

more effective at killing snails and slugs than iron baits that lack a chelating agent 

(Henderson et al., 1989; Zheng et al., 2008; Whaley, 2007). However, the Whaley 

(2007) study demonstrated that ferric phosphate alone can have at least some 

molluscicidal activity against slugs. 

• STR 192-194: Besides EDTA, at least one other chelating agent has been used in 

combination with ferric phosphate in order to increase its efficacy as a molluscicide. 

That compound is (S,S)-ethylenediaminedisuccinic acid (EDDS), a structural isomer of 

EDTA that is biodegradable (Tandy et al., 2006). 

• ARS pg. 1: The report...presents convincing evidence that ferric phosphate is toxic to 

slugs, but that it requires a chelating agent as a synergist in order to make it an effective 

product. Other types of aminopolycarboxylic acid chelating agents are available and 

EDDS, at least, is also an effective synergist.

2. Are there reasons for concern about EDTA beyond what information goes into a 

tolerance exemption, such as effects on soil organisms or contamination in 

groundwater?

• STR 273-275: there is not enough evidence to definitively conclude whether ferric 

phosphate molluscicides containing EDTA are toxic to earthworms following typical rates 

of application. 

• STR 282-283: No information was found linking the specific use of EDTA in pesticide 

formulations to groundwater pollution. 

• ARS pg. 2: The Technical Review might have gone into more detail on potential 

environmental challenges posed by EDTA and compared it to other aminopolycarboxylic 

acid chelating agents. On the one hand, industrial use of EDTA has resulted in 

detectable residues in oceans and surface water, without apparent harm. On the other 

hand, such wide distribution and concentration within sediments could have unforeseen 

effects on particular ecosystems. 

3. Does the EDTA as used with ferric phosphate pose the same concerns as the EDTA 

that was reviewed as part of the Sodium Ferric Hydroxyl EDTA? 

• STR 295-296: The EDTA used with ferric phosphate poses the same concerns that were 

raised for EDTA as part of the review of sodium ferric hydroxyl EDTA

• ARS pg. 2: The Technical Review makes the case that EDTA poses the same concerns 

whether used with ferric phosphate or as sodium ferric hydroxyl EDTA. Given the 

dynamic nature of the status of a chelated molecule of EDTA, the Technical Review’s 

conclusion seems reasonable. 

4. Are there any unbiased studies that back up the findings of Edwards et al. (2009) as 

cited in the TR or with contrasting results? Does the Edwards et al. (2009) study seem 

biased?

• STR 318-319: There are three available studies that evaluate the potential toxicity of 

ferric phosphate molluscicides containing EDTA to earthworms: Edwards et al., 2009 

(sponsored by Lonza Ltd.); Langan and Shaw, 2006 (not sponsored by Lonza Ltd., 

however the authors were assisted by two Lonza employees); Luhrs, 2009 (sponsored 

by Neudorff). 

• STR 411-413: Based on the available studies (summarized in Table 2), there is not 

enough evidence to definitively conclude whether ferric phosphate molluscicides 

51
containing EDTA are toxic to earthworms following typical rates of application. All of the 

studies have strengths and limitations. 

• ARS pg. 2: Although the Technical Review concludes that there is not enough 

information to conclude with certainty that ferric phosphate slug-control products are 

harmful to earthworms, the study by Langan and Shaw (2006) certainly seems to be 

independently gathered data showing that under some conditions and for some 

earthworm species, Sluggo-type products can be harmful. Accepting this conclusion 

would indicate that the Edwards study is not likely to be biased. 

STR and ARS responses have been incorporated into the Checklist. Despite the information 

presented in the STR, the Crops Subcommittee recommends to vote down the petition to 

remove Ferric Phosphate from the National List. The generic active ingredient, Ferric 

Phosphate, needs to be considered separately from any other ingredients, either active or 

inert.

The inerts in the formulated Ferric Phosphate product are allowed under section 

205.601(m)(1). Because of this, the generic ferric phosphate substance should remain on the 

National List. The NOSB-NOP-EPA Working Group on Inerts (IWG) will address the topic of 

inerts in pesticide products. 

Minority View

The supplemental information received by the Crops Subcommittee concludes that it is 

actually the combination of at least two ingredients, ferric phosphate and EDTA, that 

establishes the efficacy of the registered product currently allowed under the ferric phosphate 

listing: § 205.601 Synthetic substances allowed for use in organic crop production, (h) As slug 

or snail bait. Ferric phosphate (CAS # 10045–86–0).

ARS pg. 1, as cited above, states, “[The TR] presents convincing evidence that ferric 

phosphate is toxic to slugs, but that it requires a chelating agent as a synergist in order to 

make it an effective product.” The STR, line 82, states,

“[I]n a letter to the NOSB, the technical director for OMRI comments, “Based on the 

evidence compliled by OMRI, ferric phosphate as currently listed at 205.601(h) is not 

effective as an active ingredient without an additional chelating agent, such as EDTA,” 

and, “chelating agents such as EDTA facilitate the absorption of the metal into the 

body.” (OMRI, 2010)”

STR, line 90, states, “Puritch et al. (1995) claimed that an effective mollusc bait would be 

composed of both a simple iron compound and a second component, such as edetic acid 

(EDTA), hydroxyehyl derivative of edetic acid, or a salt of these acids. It also stated that 

individually neither component is toxic to terrestrial molluscs, but the composition becomes 

toxic once it is ingested. Therefore, this patent suggests that a chelating agent such as EDTA 

is necessary for ferric phosphate to be an effective molluscicide.”

In the lexicon of pesticide law, a material that is incorporated into a pesticide for the purpose of 

killing the target pest, and therefore necessary to kill, or elevate its efficacy in killing the target 

pesticide, is considered an active ingredient in that product. Therefore, EDTA must be 

evaluated an active component of the mixture of chemicals in the current slug or snail bait 

allowed under section 205.601(h).While ferric phosphate or similar iron salts may express toxic 

52
properties, as identified in several studies, STR, line 117, indicates that, “It [Henderson et al., 

1989] was reported that the baits containing the chelated compound killed a greater proportion 

of the slugs than the baits with the simple, iron salt, but quantitative results and tests of 

statistical significance were not provided.” Other studies do show less efficacy associated with 

pure iron phosphate baits when compared to the chelated baits.

The minority view holds that the use of EDTA is integral to killing the slug and snail as the 

target organism with the level of efficacy to be of value in the field. Therefore, the petitioner is 

correct that EDTA is an active ingredient in the materials allowed under section 205.601(h) 

since under this provision “ferric phosphate” is not sold for slug or snail bait without EDTA for 

its active properties and therefore must be evaluated in reaching a determination on its

acceptability for listing on the National List.

The ARS review, pg 2, and the STR, line 295, find that, “The EDTA used with ferric phosphate 

poses the same concerns that were raised for EDTA as part of the review of sodium ferric 

hydroxyl EDTA.” 

STR, line 298 states, “The NOSB Crops Committee voted to reject sodium ferric 

hydroxyl EDTA (SFH EDTA) for use as a slug and snail bait in 2007 (NOSB Crops 

Committee, 2007). The reasons cited for rejection were that ferric phosphate is already 

listed for that use, concerns about potential harm to humans and the environment, and 

inconsistency with organic farming and handling. The Crops Committee concluded that 

EDTA clearly has the potential to be harmful to the environment and can result in the 

detrimental movement of metals in soils and river sediments. Furthermore, the Crops 

Committee was concerned about EDTA’s slow rate of biodegradation and its 

persistence in the environment. The EU Commission risk assessment on EDTA (EC, 

2004) was cited as the reference for this conclusion. The potential harmful effects of 

EDTA on human health were also a concern to the Crops Committee. In particular, the 

Committee concluded that “EDTA is a very strong metal chelating agent, especially for 

calcium. It is poorly absorbed in mammalian GI tract and concerns have been raised 

that excessive usage in food could deplete the body of Ca and other minerals” (NOSB 

Crops Committee, 2007).”

The minority view associated with these facts supports the claims of the petitioner.

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: [ ] Comments: 

Proposed Annotation (if any): N/A

53
Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Recommended Subcommittee Action & Vote, including classification recommendation 

(state actual motion): Motion to remove Ferric Phosphate from section 205.601(h)

Classification Motion: N/A

Listing Motion: Motion to remove Ferric Phosphate from section 205.601(h)

Motion by: Carmela Beck Seconded by: Jay Feldman

Yes__3___ No__5__ Abstain__0__ Recuse__0__ Absent__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. 601(h) 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: 

4

Substance was recommended to be deferred because:

 

If follow-up needed, who will follow up: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 15, 2012

NOSB Evaluation Criteria for Substances Added To the National List

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

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

regulatory agency; other) 1,

2

1. Are there adverse effects on environment 

from manufacture, use, or disposal?

X

1 Unidentified line numbers refer to the Ferric Phosphate TR, June 15, 2010.

2 STR labeled line numbers refer to the Supplemental Ferric Phosphate TR, July 26, 2012.

54
[§205.600 b.2]

2. Is there environmental contamination during 

manufacture, use, misuse, or disposal? 

[§6518 m.3]

X The only by-products of this process are 

sodium sulfate and water. Sodium sulfate is 

precipitated with lime and used as a 

secondary raw material. The water is 

released into a wastewater clarification plant 

(260-261). No information was found linking 

the specific use of EDTA in pesticide 

formulations to groundwater pollution (STR 

282-283). While reported as occurring 

naturally in soil, ferric phosphate, if combined 

with chelating agents such as EDTA or EDDS 

may cause the accumulation of larger 

concentrations of iron than would be 

expected under normal conditions (303-305). 

On the one hand, industrial use of EDTA has 

resulted in detectable residues in oceans and 

surface water, without apparent harm. On the 

other hand, such wide distribution and 

concentration within sediments could have 

unforeseen effects on particular ecosystems 

(ARS, pg. 2).3

 [Minority view addition: Sodium 

cyanide and formaldehyde are used in 

making EDTA.4]

3. Is the substance harmful to the environment 

and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X Another important issue is the level of 

mammalian toxicity of iron phosphate-based 

molluscicides containing EDTA or other 

chelating agents, especially since if chelating 

agents increased the uptake of iron from soils 

into crops they may be fed upon by humans 

(342-345). The EPA (1998) states: A number 

of ecological effects toxicology data 

requirements were waived based on the 

known lack of toxicity of iron phosphate to 

birds, fish and non-target insects, its low 

solubility in water, conversion to less soluble 

form in the environment (soil), and its use 

pattern (soil application). (424-426). 

Submitted studies involving ground beetles, 

rove beetles and earthworms demonstrated 

that the product will not affect these 

organisms at up to two times the maximum 

application rate (430-432). If NOP’s 

consultant who wrote Report had had access 

to Neudorff’s Opinion, he would have seen 

that Edwards et al (2009) serves to 

demonstrate the harmlessness of NEU1165M 

Slug & Snail Bait to earthworms when it is 

applied at the recommended application rate 

(Talarek, 7)5

. This section also states that 

assuming the reports of mammalian toxicity 

are accurate, that would demonstrate the 

potential for some level of persistence on the 

food chain. This is a non-sequitur. If one 

3 USDA Agricultural Research Service (ARS) review of the STR, June, 26, 2012. 4 http://en.wikipedia.org/wiki/Ethylenediaminetetraacetic_acid 5 Law Offices of Walter G. Talarek, P.C. letter to the NOP, October 7, 2011.6 Unidentified line numbers refer to Ferric 

Phosphate TR, June 15, 2010.

55
reads the reports of adverse incidents 

reported to EPA, one sees that most 

incidents involve minor acute effects that 

immediately follow oral exposure of dogs to 

the product; the incidents do not occur one 

month, two months, or a year after 

exposures. The environmental impact of ferric 

phosphate slug & snail baits is clear – there is 

none (Talarek, 7). [Minority view discussion: 

Combination toxic to earthworms, perhaps 

more. (409-417)6

TR discusses Edwards et al 

(2009) conclusions, “Clearly, molluscicides 

containing iron phosphate and EDTA or 

EDDS chelating agents may present 

significant environmental hazards to 

earthworms, domestic animals and humans 

and these issues need further investigation. 

The registration statuses of these chemicals 

in USA and Europe should be reviewed in 

light of these new data and conclusions 

“(Edwards, et al. 2009). The TR says “This 

also illustrates a mode by which ferric 

phosphate could be introduced into the food 

chain.” (347-351) Although the Technical 

Review concludes that there is not enough 

information to conclude with certainty that 

ferric phosphate slug-control products are 

harmful to earthworms, the study by Langan 

and Shaw (2006) certainly seems to be 

independently gathered data showing that 

under some conditions and for some 

earthworm species, Sluggo-type products can 

be harmful. Accepting this conclusion would 

indicate that the Edwards study is not likely to 

be biased. (ARS)]

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 During the formulation process, there are no 

chemical reactions which form ferric EDTA or 

ferric phosphate EDTA as an active 

ingredient (Talarek, 5). [Minority view 

discussion: EDTA can result in the 

detrimental movement of metals in soils and 

river sediments (EU Commission Risk 

Assessment on EDTA)]

6. Are there adverse biological and chemical 

interactions in agro-ecosystem? [§6518 m.5]

X [Minority view discussion: Grčman et al. 

(2003) found that addition of 10 mmol 

EDTA/kg soil (2920 mg/kg) decreased the 

structure of the fungal community in heavy 

metal polluted soil compared to a control 

treatment on days 1 and 56 after application. 

Results of a different trial showed that EDTA 

caused stress to soil microorganisms, as 

indicated by a significant increase in the trans

to cis phospholipid fatty acid ratio (Grčman et 

al., 2003). 

Epelde et al. (2008) studied the effects of 

6 Unidentified line numbers refer to Ferric Phosphate TR, June 15, 2010.

56
EDTA (1000 mg/kg soil) on soil enzyme 

activities, potentially mineralizable nitrogen, 

soil basal microbial respiration, and substrate 

induced respiration (a measure of potentially 

active microbial biomass). In control nonpolluted soils, EDTA caused a significantly 

negative effect on the soil microbial 

community activity (evidenced by a decrease 

in dehydrogenase activity and basal 

respiration). Examples of phytotoxicity 

observed in studies following the addition of 

EDTA to soil (1000-2920 mg EDTA/kg soil) 

include necrotic lesions on cabbage 

leaves/lowered yield of cabbage biomass, 

decrease of corn growth to 60% of control, 

signs of chlorosis and necrosis in white bean, 

and decreased biomass of cardoon plants 

(Grčman et al., 2003; Evangelou et al., 2007; 

Epelde et al., 2008). The studies 

demonstrating toxic effects of EDTA on soil 

microorganisms and plants involved EDTA 

soil concentrations that are much greater 

than the EDTA soil concentration expected 

from the use ferric phosphate baits, but it is 

not known if toxic effects on soil 

microorganisms and plants would occur from 

the use of slug and snail baits containing 

EDTA because no studies were found that 

tested relevant concentrations of EDTA in 

soil. (STR 237-269) Also, EDTA is not 

degraded rapidly in the environment and is 

the most abundant anthropogenic chemical in 

some European surface waters (SFHEDTA 

checklist7)]

7. Are there detrimental physiological effects on 

soil organisms, crops, or livestock? [§6518 

m.5]

X The EPA (2008) reported 5 domestic animal 

deaths, 8 major domestic animal incidents 

and 106 moderate and minor domestic 

animal incidents from the sue of iron 

phosphate slug and snail baits marketed in 

the USA up to May 7, 2008 (322-324). While 

this may be true, it is important to note that 

when the incident reports are reviewed 

carefully, in most cases, and in particular with 

regard to the reports of domestic animal 

deaths and major animal incidents, there are 

speculative exposures to the products, 

animals had preexisting conditions which 

were more likely to have caused the effects 

or there were exposures but the effects could 

not have been caused by the products; 

however, Neudorff felt that it was obligated 

under the law to report all incidents no matter 

how remote the exposure an effect 

relationship (Talarek, 5). EPA’s August 13, 

1997, Decision Memorandum on 

“Consideration of Registration of an end-use 

7 SFHEDTA Checklist is the checklist produced by the Crops Committee for Sodium Ferric Hydroxyl EDTA November 

2007.

57
product (NEU1165M Slug & Snail Bait, EPA 

File Symbol 67702-G)...does not indicate that 

there is a significant hazard to humans or 

domestic animals (Talarek, 6). EPA has 

issued tolerance exemptions for ferric 

phosphate & all the inert ingredients in 

Neudorff’s slug & snail baits, thus indicating 

that these chemicals are safe to humans if

used according to good agricultural practice 

(Talarek, 6). Neudorff’s opinion contains 

documentation demonstrating that ferric 

phosphate slug & snail baits are not harmful 

to earthworms & other non-target organisms 

(Talarek, 6). Based on the available studies, 

there is not enough evidence to definitively 

conclude whether ferric phosphate 

molluscicides containing EDTA are toxic to 

earthworms following typical rates of 

application (STR 411-413). [Minority view 

discussion: “Clearly, molluscicides containing iron phosphate and EDTA or EDDS chelating 

agents may present significant environmental 

hazards to earthworms, domestic animals 

and humans and these issues need further 

investigation. The registration statuses of 

these chemicals in USA and Europe should 

be reviewed in light of these new data and 

conclusions “(Edwards, et al. 2009). (348-

351)] Although the Technical Review 

concludes that there is not enough 

information to conclude with certainty that 

ferric phosphate slug-control products are 

harmful to earthworms, the study by Langan 

and Shaw (2006) certainly seems to be 

independently gathered data showing that 

under some conditions and for some 

earthworm species, Sluggo-type products can 

be harmful. Accepting this conclusion would 

indicate that the Edwards study is not likely to 

be biased. (ARS)]

8. Is there a toxic or other adverse action of the 

material or its breakdown products?

[§6518 m.2]

X The EPA describes ferric phosphate as 

ubiquitous in nature. It is a solid. It is not 

volatile and does not readily dissolve in 

water, which minimizes its dispersal beyond 

where it is applied (291-292). [Minority 

view:See above, 6 and 7.]

9. Is there undesirable persistence or 

concentration of the material or breakdown 

products in environment? [§6518 m.2]

X Examples of the solubilization of phosphate 

from ferric phosphate by soil microorganisms 

such as Penicillium radicum & others, are 

common in literature. It is also reported to 

occur naturally in the soil as fertilizer (278-

280). [Minority view discussion: Assuming the 

reports of mammalian toxicity are accurate, 

that would demonstrate the potential for some 

level of persistence in the food chain. (414-

415) ). EDTA is not degraded rapidly in the 

environment and is the most abundant 

anthropogenic chemical in some European 

surface waters (SFHEDTA checklist.)]

58
10. Are there any harmful effects on human 

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

§6518 m.4]

X No unreasonable adverse effects to human 

health are expected from the use of iron 

phosphate (467). One might presume that

only the reports of mammalian toxicity cited in 

question 9 are likely to be of potential 

concern. (503-504); Neudorff states that there 

are no reports of mammalian toxicity cited in 

the discussion of Evaluation Question #9. 

There is only the statement “[a]ssuming the 

reports of mammalian toxicity are accurate, 

that would demonstrate the potential for some 

level of persistence in the food chain”. Not 

only does the discussion under Question #9 

not list or discuss any such reports, but the 

one sentence in the section mentioning 

reports of mammalian toxicity is a nonsequitur (Talarek, 8).

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.

59
NOSB Evaluation Criteria for Substances Added To the National List

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

Phosphate 

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

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

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)]

X

4. Is there a natural source of the substance? 

[§205.600 b.1]

X Ferric phosphate occurs in nature but the 

natural source is not able to be commercially 

produced [Minority view discussion: It is not 

effective for mollusc control without EDTA. 

(ARS)]

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 Examples have been reported in various 

semi-professional literature, albeit they are 

intended for home and garden use rather 

than agricultural purposes (513-519). The “All 

Natural Snail & Slug Spray RTU”...is not 

registered with EPA...this RTU product is 

intended for home & garden use, which 

means it might be impractical for agricultural 

use (Talarak, 8).

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 Many of the “natural” remedies or deterrents 

for slugs and snails are abundant in the semiprofessional literature, such as home and 

gardening publications and blog sites on the 

internet (529-537). Copper tape, 

diatomaceous earth.8

The discussion lists spot 

treating with ammonia solutions, spraying 

with salt solutions, direct removal of slugs & 

snails observed & placement into containers 

of soap, water alcohol or other harsh solution 

to kill them, & predators, such as birds, 

mammal & toads. However, none of these 

methods are practicable for commercial 

agriculture (Talarek, 8).

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6]

X One last important point to mention is that no 

organic growers have supported Steptoe & 

Johnson’s petition, and organic growers have 

8 Petition for sodium ferric hydroxyl EDTA, p. 20

60
supported the continued listing of ferric 

phosphate (Talarek, 8). [Minority view 

discussion: The direct removal of any slugs or 

snails observed and placement into a 

container of soap [type not specified] and 

water, alcohol, or other harsh solution to kill 

them. Birds, small mammals, and especially 

toads, have been said to be predators on 

slugs and snails, but are obviously not readily 

controllable. (532-535) Cultivation.9

] 

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.

9 Petition for sodium ferric hydroxyl EDTA, p. 21

61
NOSB Evaluation Criteria for Substances Added To the National List 

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

Phosphate

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

regulatory agency; other)

1. Is the substance compatible with organic 

handling? [§205.600 b.2]

X

2. Is the substance consistent with organic 

farming and handling? [§6517 c (1)(A)(iii); 

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

X Ferric Phosphate is the only effective 

molluscicide available to organic growers. 

[Minority view discussion: It’s a synthetic 

material that does not present a compelling 

need for it as well as the toxic substances 

necessary for its manufacture.]

3. Is the substance compatible with a system of 

sustainable agriculture? [§6518 m.7]

X Following typical rates of application, ferric 

phosphate + chelator baits do not harm 

earthworms. No information was found linking 

the specific use of EDTA in pesticide 

formulations to groundwater pollution (273-283).

[Minority view discussion: EDTA is inert under 

some circumstances and can build up in soil. 

It is the most abundant anthropomorphic 

chemical in some European surface waters. It 

can enhance the movement of metals in soil 

and river sediments.(EU commission risk 

assessment on EDTA)]

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; X

c. pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals?

X Ferric phosphate is a mineral. [Minority view 

discussion: Ferric phosphate plus EDTA does 

not fit into any category.]

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.

62
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: Name

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

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.

63
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Oxidized Lignite/Humic Acid 

August 15, 2012

Introduction:

A petition was submitted requesting the addition of “Humic Acid Derivatives – Hydrogen 

Peroxide extracted”, which is also known as Oxidized Lignite. 

Background:

The Crops Subcommittee encountered considerable confusion over what this material actually 

is and whether leonardite humates subject to oxidation in the environment could also be known 

as oxidized lignite. A Technical Evaluation Report (TER) was commissioned to address the 

nature of this petitioned substance and compare it to the other humic acid derivatives that are 

alkali extracted as per National List section 205.601(j)(3).

Relevant Areas in the Rule:

The National List includes at §205.601(j)(3)

Humic acids—naturally occurring deposits, water and alkali extracts only.

Discussion:

In reviewing the information in the TER it was apparent that a substance named oxidized 

lignite could occur through natural processes in the field or through using super-heated water 

or ozone in a lab (TER lines 258 - 263). However since the manufacturing process in this 

petition is redacted as Confidential Business Information, it is not clear how to propose listing 

this substance to distinguish it from these other methods of production. Therefore the motion 

that is being proposed is to add Hydrogen Peroxide extraction to the annotation for Humic 

Acids on the National List. Included in the motion is that this new clause will expire in 2017, to

enable all the humic acids to be re-reviewed together at their normal sunset date. 

The Crops Subcommittee noted in their review that leonardite materials extracted with 

hydrogen peroxide do not have any residual synthetic materials in the end product because 

the hydrogen peroxide breaks down completely into water and oxygen. Humic Acids that are 

alkali extracted do contain a surplus of potassium or other cations from the extractant, and it 

has never been clear what amount of alkali is necessary for the extraction but is not 

considered fortification.

Another key issue in the deliberation over this material is the fact that there are many 

alternative substances and practices that can be used to enhance plant uptake of nutrients, 

which is the primary use for this product class. The justification statement in the petition only 

compared hydrogen peroxide extraction with alkali extraction for humic acids, but did not 

address the bigger context of soil-building practices as alternatives. The TER did address the 

soil-building practices and alternative substances that can be used. However, the contention 

by the petitioner that humic acids must be deliverable in liquid form was not discussed in the 

TER. The Subcommittee majority does not feel that the need for nutrients in liquid form is a 

compelling reason to distinguish this from the alternatives.

64
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: [2,3] Comments: 

Proposed Annotation (if any): "Humic acids – naturally occurring deposits, water, alkali and 

hydrogen peroxide extracts only.”

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

Notes: 

Recommended Subcommittee Action & Vote, including classification recommendation 

(state actual motion):

Motion: 

Humic Acids – Hydrogen Peroxide extracted are synthetic.

Motion by: Zea Sonnabend Seconded by: Colehour Bondera

Yes__8___ No__0__ Abstain__0__ Recuse__0__ Absent__0__ 

Listing Motion: 

To change the listing in [7 CFR 205.601(j)(3)] to: "Humic acids – naturally occurring 

deposits, water, alkali and hydrogen peroxide extracts only, to expire in 2017.” 

Motion by: Zea Sonnabend Seconded by: John Foster

Yes__3___ No__5__ Abstain__0__ Recuse__0__ Absent__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. 601(h) 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: 

65
4

Substance was recommended to be deferred because 

 

If follow-up needed, who will follow up: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 15, 2012

NOSB Evaluation Criteria for Substances Added To the National List

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

Hydrogen Peroxide extraction

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

2. Is there environmental contamination during 

manufacture, use, misuse, or disposal? 

[§6518 m.3]

X There may be environmental contamination 

from coal mining (see TER 339-340) "surface 

mines are more likely than underground 

mines to result in surface water pollution." 

The treatment with hydrogen peroxide may 

release carbon dioxide into the atmosphere, 

but because of the CBI that cannot be 

determined. (TER 343-346)

3. Is the substance harmful to the environment 

and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

TR 394-396: Humic substances appear to 

depress some organisms in the environment 

while stimulating others (Peterson, 1989). 

There is therefore no clear-cut answer to this 

criteria.

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 If anything the use of such humic substances 

would enhance the uptake of other fertilizer 

materials. (TER lines 353-354)

6. Are there adverse biological and chemical 

interactions in agro-ecosystem? [§6518 m.5]

? There is always a potential for detrimental 

interactions, but in the TER lines 356-357: 

"However, because of their widely varying 

structures and functions, it is difficult to 

predict with certainty the effects of humic 

substances in the soil." 

7. Are there detrimental physiological effects on 

soil organisms, crops, or livestock? [§6518 

m.5]

X TER 404-412: "The impact of oxidized lignite 

on soil organisms is inconclusive."

8. Is there a toxic or other adverse action of the 

material or its breakdown products?

[§6518 m.2]

X While the TER discusses concerns over the 

humic substances in drinking water and in 

aquatic environments (TER lines 365-369 and 

386 - 388), there is no reason to think the 

substance would end up in these places as 

used in organic farming.

9. Is there undesirable persistence or 

concentration of the material or breakdown 

products in environment? [§6518 m.2]

X Lignite itself is very persistent (TER lines 279 

- 280) but the reacted versions of it will break 

down faster. Persistence in this case is not 

undesirable as the unreacted humates are 

used in organic agriculture for their long-term 

66
benefits.

10. Are there any harmful effects on human 

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

§6518 m.4]

X X The TER in lines 302 - 326 gives extensive 

literature on the negative effects of coal and 

coal dust on human health. However these all 

stem from burning coal for fuel, hazards in 

mining coal, and if lignite ends up in drinking 

water. None of them relate to any harmful 

effects from using extracted humic acids as a 

soil amendment.

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.

67
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? Substance: Humic Acids – 

Hydrogen Peroxide extraction

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

regulatory agency; other)

1. Is the substance formulated or manufactured 

by a chemical process? [6502 (21)]

? Unknown because of CBI

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

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)]

X Oxidized lignite may be created by naturally 

occurring processes, but that is why this 

substance is referred to as hydrogen peroxide 

extracted Humic Acids.

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

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 TER 502: "Non-synthetic lignite may be used 

in place of the liquefied oxidized or alkali 

treated lignite." TER 522: "It is also possible 

to treat lignite coal by microbial fermentation 

(Catcheside and Ralph, 1999)."

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 TER 491-498: "Compost, cover crops, 

manure, mulch, and other natural sources of 

organic matter can all increase humic acid 

content of the soil (Magdoff and Weil, 2004). 

Humic acids from decaying organic matter 

have been empirically shown to have the 

same benefits as those from fossil sources, 

such as lignite (Weil and Magdoff, 2004)." 

TER 557: "Synthetic ligninsulfonates are also 

used as chelating agents for micronutrients [7 

CFR 205.601(j)(4)]."

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6]

X Any soil-building practice that increases the 

organic matter in soil will be similar in action 

to these substances, only they take more 

time. Green manures, rotation, incorporating 

crop residues and using compost are all 

equivalent to the use of these substances. 

(TER 569 - 581) 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.

68
NOSB Evaluation Criteria for Substances Added To the National List

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

Acids – Hydrogen Peroxide extraction 

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

regulatory agency; other)

1. Is the substance compatible with organic 

handling? [§205.600 b.2]

X

2. Is the substance consistent with organic 

farming and handling? [§6517 c 

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

X As the organic rule is written, synthetic 

substances for crop inputs must fall within 

one of the exception areas mentioned in 

#7 below. Since this does not, it cannot 

be considered consistent with the rule.

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

X X While agronomically this appears to be a 

compatible material and humic 

substances are primarily beneficial to soil 

and plants, the concerns over coal mining 

to produce the starting ingredient do not 

contribute to the overall sustainability of 

this materials over other practices.

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; 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.

69
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: Humic Acids – Hydrogen Peroxide extraction

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

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.

70
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Propylene Glycol Monolaurate (PGML)

August 7, 2012

Introduction: 

PGML has been petitioned to be added to section 205.601(e) of the National List. PGML is an 

acaricide; a pesticide that kills members of the Acari group – ticks and mites. Stated in the 

petition (pg. 5), specifically PGML is seen as, “a broad spectrum antimicrobial agent to control 

fungi and bacteria that cause decay of post-harvest fruit and vegetables.” 

Relevant areas in the Rule:

The National List includes at §205.601(e)

As insecticides (including acaricides or mite control).

Discussion: 

While potentially useful as an additional tool for controlling Acari pests, it is not needed as it 

can be substituted with alternatives including cultural practices and biological controls -- other 

options are available which do not have the impacts on human and environmental health. That 

the environmental impacts leave more damage overall than benefit, is of notable concern, 

when considered in regard to efficacy. As a synthetic product, this material is not consistent 

with either organic nor sustainable production systems. As a tool made for use in conventional 

agricultural systems, PGML does not serve as an organic system tool.

Those who supported adding PGML to the National List said that while there are other organic 

options, they are very sporadic in how well they control the target pests or even under certain 

circumstances if they will control them at all. The impact on crop quality, and the potential 

environmental impact when using the alternative materials can be somewhat of a concern, as 

well. Giving organic farmers another tool that is better than those they currently rely upon is 

exactly what this process is all about if we can properly look at the risk/ benefit.

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: [1, 2, 3]

Proposed Annotation (if any): 

71
Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Recommended Subcommittee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: 

PGML is synthetic.

Motion by: Colehour Bondera Seconded by: Zea Sonnabend

Yes__8___ No__0__ Abstain__0__ Recuse__0__ Absent__0__ 

Listing Motion: 

Add PGML to the National List §205.601(e) as an acaracide.

Motion by: Colehour Bondera Seconded by: John Foster

Yes__2___ No__6__ Abstain__0__ Recuse__0__ Absent__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. 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 § 205.601(e). Describe why 

material was rejected: 

Not needed and environmental impacts too costly.

4

Substance was recommended to be deferred because 

 

If follow-up needed, who will follow up: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 7, 2012

72
NOSB Evaluation Criteria for Substances Added To the National List

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

Monolaurate (PGML) 

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

2. Is there environmental contamination during 

manufacture, use, misuse, or disposal? 

[§6518 m.3]

X There can be with misuse or disposal since 

beneficials can be destroyed... Human 

irritation if mis-used. Feedstock for 

manufacture comes from petroleum, natural 

gas or coal. Manufacture requires burning of 

petroleum, thus greenhouse gas production. 

See TR - line 231 onward.

3. Is the substance harmful to the environment 

and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X Fossil fuel dependent (234-6).

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

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

X List 4B.

5. Is there potential for detrimental chemical 

interaction with other materials used?

[§6518 m.1]

X Can enhance toxicity of other ‘biocides’ (255).

6. Are there adverse biological and chemical 

interactions in agro-ecosystem? [§6518 m.5]

X Both beneficial mites (soil food web & organic 

matter decomposers) and fungi directly 

impacted; limited studies (283-299 & 309-

316)...

7. Are there detrimental physiological effects on 

soil organisms, crops, or livestock? [§6518 

m.5]

X Potential impact on soil food web mites (283-

299 & 309-316).

8. Is there a toxic or other adverse action of the 

material or its breakdown products?

[§6518 m.2]

Unclear/unknown.

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 Minimal, but can cause short-term skin and 

eye reactions (328-335). PGML is a “Toxicity 

Category III” substance in terms of eye 

irritation (US EPA Fact Sheet, 2004). As 

listed in 40 CFR 156.62, US EPA establishes 

the four toxicity categories: I, II, III and IV. 

Toxicity category I is highly toxic and severely 

irritating, category II moderately toxic and 

moderately irritating, category III slightly toxic 

and slightly irritating, and category IV 

practically non-toxic and not an irritant. 

Toxicity category III substances cause eye 

irritation effects, but the irritation effects are 

reversible within seven days. Toxicity 

category IV substances do not cause eye 

irritation effects. 

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 X

73
to FDA’s good manufacturing practices? 

[§205.600 b.5]

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.

74
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? 

Substance: Propylene Glycol Monolaurate (PGML) 

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

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 Manufactured from petroleum, natural gas, or 

coal by a process involving chemical change.

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)]

X Could be, however commercially it is not...

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

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 Non-synthetic botanical and fungal-derived 

acaricides (354).

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 Horticultural oils (petroleum distillates), 

soaps, sulfur and sucrose octanoate esters 

(SOE) also appear on the National List and 

are used to control mites in organic 

production (360-1).

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6]

X Rotation, nutrient management, selection of 

mite-resistant varieties, and the release of 

predators and parasites (342), dust 

management, resistant varieties and 

biological controls (370-398). Water 

management is a viable practice as well.

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.

75
NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: Propylene Glycol Monolaurate (PGML) 

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

agency; other)

1. Is the substance compatible with organic 

handling? [§205.600 b.2]

X

2. Is the substance consistent with organic 

farming and handling? [§6517 c (1)(A)(iii); 

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

X Toxic to aquatic life.

3. Is the substance compatible with a system of 

sustainable agriculture? [§6518 m.7]

X No, petroleum based.

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; X

c. pheromones, soaps, horticultural oils, fish 

emulsions, treated seed, vitamins and 

minerals?

X Glycol esters do not appear in an OFPA 

category. In evaluating the petition for 

sucrose octanoate esters (SOE), the NOSB

determined that esters are equivalent in their 

manufacture and mode of action to ‘soap,’ 

which appears as a category of synthetic 

authorized for use in production on the 

National List at 7 U.S.C. §6517(c)(1)(B)(i) 

(NOSB, 2005) (116-119). However, the 

PGML molecule does not have the 

hydrophilic-lipophilic structure of a soap (27-

28), as also seen by its solubility in organic 

solvents, low water solubility, high 

saponification value, and low hydrophiliclipophilic balance value, all of which indicate a 

substance that is lipophilic, but does not have 

the hydrophilic-lipophilic structure of a soap 

(38-44).

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.

76
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: 

Propylene Glycol Monolaurate (PGML) 

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

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.

77
National Organic Standards Board

Crops Subcommittee

Policy and Procedure Proposal

Other (“Inert”) Ingredients in Pesticide Formulations on the National List

August 22, 2012

Introduction

This Policy and Procedure Proposal for review of other (“inert”) Ingredients in pesticide 

formulations on the National List addresses the many recommendations of the NOSB and 

concerns of the public about the crop production materials that are allowed for use in certified

organic production under the National List section of OFPA (7 USC 6517). 

This proposal consists of a roadmap for initiating the review of these substances in groups 

over a four year timespan, with the goal of completing the majority of the reviews by the end of 

the current sunset period for §205.601(m) and §205.603(e) (the sections in 7 CFR 205 that list 

inert ingredients) in October of 2017. This document contains a proposal for new regulatory 

language, a series of steps to use in preparing for inerts review, screening guidelines that the 

Technical Evaluation Reports (TERs) will address, a tentative list of the proposed groups, and 

a rough timeline for review and completion. 

In order to initiate development of the necessary TERs by 2013, a vote on moving forward at

the Fall 2012 NOSB meeting will be followed by additional details on the procedure, which will

be finalized at the Spring 2013 meeting of the Board. Though it is recognized that many of 

these substances are not truly “inert,” this proposal retains use of the word inert in the 

regulatory language “inert (other) ingredients,” as that is the terminology used in Environmental 

Protection Agency (EPA) regulations and the Organic Foods Production Act of 1990 (OFPA). 

However, like EPA, the NOSB encourages the labeling of products permitted in certified 

organic production with the phrase “other ingredients” per EPA’s finding, “Since neither federal 

law nor the regulations define the term "inert" on the basis of toxicity, hazard or risk to humans, 

non-target species, or the environment, it should not be assumed that all inert ingredients are 

non-toxic.”

1

 

Background

In 2006, EPA reassessed all inert ingredients used in pesticide formulations allowed on food 

crops, including former Lists 3, 4A, and 4B inerts, to ensure that they met the tolerance 

reassessment requirements of the Food Quality Protection Act. Inerts allowed for use in EPA 

registered pesticides applied to food now must either have a residue tolerance level or an 

exemption from tolerance level codified at 40 CFR Part 180. As a result of this reclassification, 

1

See EPA, Inert (other) Pesticide Ingredients in Pesticide Products - Federal Register and Pesticide 

Registration Notices on Other (Inert) Pesticide Ingredients, “In September 1997, the Environmental 

Protection Agency (EPA) issued Pesticide Regulation Notice 97-6 which encourages manufacturers, formulators, 

producers, and registrants of pesticide products to voluntarily substitute the term "other ingredients" as a heading 

for the "inert" ingredients in the ingredient statement on the label of the pesticide product. EPA made this change 

after learning the results of a consumer survey on the use of household pesticides. Many comments from the 

public and the consumer interviews prompted EPA to discontinue the use of the term "inert." Many consumers are 

misled by the term "inert ingredient", believing it to mean "harmless." Since neither federal law nor the regulations 

define the term "inert" on the basis of toxicity, hazard or risk to humans, non-target species, or the environment, it 

should not be assumed that all inert ingredients are non-toxic.” 

78
NOP regulations concerning allowed inert ingredients are out-of-date when compared with 

current EPA regulations, since EPA eliminated its list categories when it completed its 

tolerance reassessment. The NOSB recommended in April 2010 that NOP establish a task 

force in collaboration with EPA and the NOSB to examine this problem and provide a 

recommendation to the Board for re-evaluation of former List 3 and List 4 inerts. In October 

2010, the NOSB recommended the renewal until October 21, 2017 of the current exemption on 

the National List permitting former List 4 inerts “pending review by the program of inerts 

individually and as a class of materials”.2 In May 2012, the NOSB recommended an expiration 

date of October 21, 2017 for the current exemption that permits former List 3 inerts in passive 

pheromone dispensers, to coincide with the sunset date for List 4 inerts. 

The NOSB-NOP-EPA working group was established in June 2010, known as the Inerts 

Working Group (IWG). Current members include: Jay Feldman (NOSB), Zea Sonnabend 

(NOSB), Chris Pfeifer (EPA Biopesticides and Pollution Prevention Division), Kerry Leifer (EPA 

Registration Division), Emily Brown Rosen (NOP), and Lisa Brines (NOP). The group has 

collected information regarding current classification of the former List 3 and 4 inerts and 

presented a discussion document at the November 2011 NOSB meeting.3

 

For more detail on the background of inerts discussions among the NOSB and references in 

OFPA and the USDA organic regulations, please see the above referenced documents.

Regulatory Language Proposal

The NOSB proposes this language to replace the current listing at section 205.601(m) and 

205.603(e). The NOSB recommends that this change, including the listing of any approved 

(inert) ingredients, be completed prior to the October 21, 2017 sunset date for List 4 inerts: 

Current language at sections 205.601(m) and 205.603(e): 

As synthetic inert ingredients as classified by the Environmental Protection Agency (EPA), for 

use with nonsynthetic substances or synthetic substances listed in this section and used as an 

active pesticide ingredient in accordance with any limitations on the use of such substances.

Replace the language at sections 205.601(m) and 205.603(e) with: 

As synthetic other (“inert”) ingredients in pesticide formulations as classified by the 

Environmental Protection Agency (EPA) for use with nonsynthetic substances or synthetic 

substances listed in this section that are used as an active pesticide ingredient in accordance 

with any limitations on the use of such substances.

(i) Substances permitted for use in minimal risk products exempt from pesticide 

registration under FIFRA section 25(b);

(ii) Reserved (for list of approved other (“inert”) ingredients)

Discussion of Procedure

2 October 28, 2010 recommendation available at 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087999&acct=nosb 3 Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5094901&acct=nosb

79
The policy proposal creates a four-year timeframe for evaluation of inert ingredients currently 

in use in organic agriculture that are not exempt from pesticide registration under FIFRA 

section 25(b). This includes former EPA List 4b and List 3 inerts in pheromones that were 

identified through information supplied by the Material Review Organizations OMRI (Organic 

Materials Review Institute) and WSDA (Washington State Department of Agriculture). It also 

will include inert ingredients that have previously petitioned, and a call for other (inert) 

ingredients. This list so far is 126 individual substances.

The NOSB proposes review of inerts by classes or groups, rather than by individual substance. 

The NOSB believes that allowing a class of substance by group will reduce the burden of the 

Board to individually review each substance previously allowed under the exemption for former 

List 4 or former List 3 for pheromone dispensers. For the purposes of this recommendation 

only the group names are provided. However, the substances that are recommended by 

NOSB would be included by individual names and CAS numbers, entered as the class is 

reviewed, under 205.601(m) and 205.603(e) above. Below are the proposed groups, with 

approximate numbers of materials in each group:

1. Alkyl alcohols - 3 

2. Alkyl alkoxylates - 4 

3. Alkylphenol ethoxylates - 9 

4. Dyes - 2 

5. EDTA and salts - 2 

6. Fatty aid ethoxylates - 4 

7. Fatty acids esters and salts - 6 

8. Low risk polymers, as defined under 40 CFR 180.960 - 8 

9. Mineral acids, bases and their inorganic salts -22

10.Organic acids and salts - 3 

11.Polyalkoxlylates and polyalkoxylated alkyl ethers - 5 

12.Polysorbates - 5 

13.Preservatives/antioxidants - 7 

14.Tall oil and terpene derivatives - 5 

15.Nonsynthetic - 14

16.Others - 27

The IWG is continuing to work in consultation with the EPA and the NOSB to categorize some 

of the many substances in the "other" category into additional or existing groups. The full group 

listing, including the list of chemicals, will be presented at the Spring 2013 NOSB meeting.

It is expected that 4-6 groups of chemicals will be evaluated every year during the four year 

period beginning in 2013. Should manufacturers identify ingredients in use that are not on the 

list for review, they will have time to come forward with a request for review. After this process 

is complete, manufacturers will be required to petition for the addition of new other ingredients, 

or “inerts,” in pesticide formulations to the National List. 

Given the scope of TERs and NOSB evaluation of these materials, it is recognized that 

completion of this process will take substantial resources and time. The current projected 

timeline will involve NOSB completion of all reviews by its Spring 2015 public meeting to 

enable the NOP to complete rulemaking by October 2017, the sunset date for List 4 inerts. 

80
Because of the challenge that this presents, the NOSB will assess the viability of the timeline 

after it completes the recommendation on the first few groups of materials. 

Proposed Procedure

A. The NOSB will work with the IWG to finalize groups and screening steps.

B. The NOSB will rely on the IWG to consult with OMRI and WSDA for updated inerts lists 

in case there are new inerts to add to the groups. 

C. The NOSB requests NOP to investigate and adopt within six months of the 

announcement of this proposal (Spring 2013) the appropriate mechanism for notifying

manufacturers and the public regarding the inerts review process, including which inerts 

are under review and how to inform the IWG of inerts that are in use, but not on the list 

under review. . 

D. The NOSB requests NOP to commission one TER per group, except where noted, and 

coordinate review with the Board. 

E. The NOSB requests NOP to determine an appropriate format and commission a special 

inerts TER for each group to contain the following:

a. a chart of all inerts in the groups by CAS number with their chemical properties, 

uses, types of product categories in which they occur, EPA regulatory status, 

including data gaps.

b. a description of how inerts within group are related and how different, especially 

outliers that are significantly different from others.

c. a chart that evaluates each inert in the group under the screening steps 

suggested by NOSB (Appendix 1) and any additional screening recommended 

by the NOSB, with input from the IWG. 

d. OFPA criteria will be addressed that are not covered in the EPA review 

(environment, interactions, and alternatives or essentiality) 

F. Based on results of group TER, the NOSB Crops Subcommittee accepts group to move 

forward to NOSB agenda, or singles out one or more for individual review. The group 

will then move forward without the singled out one and that one will be re-reviewed in 

more detail if necessary.

G. The NOSB, working with the IWG, will prioritize the order of reviews so that the most 

potentially problematic are reviewed first. The others can be done later and some may 

not need full TERs. Priority also given to fully disclosed ones that have been petitioned 

and may fall outside one of the groups. In setting priorities, there will be consideration of 

the amount used in organic production if that can be determined.

H. The anticipated timeline will enable the NOSB to finalize the procedure by Spring 2013, 

start reviews for fall 2013 and to have as many reviews completed as possible by 

Spring 2015. The intention is to have an amendment to the National List in 2017, which 

will address the materials reviewed with an implementation period of 2 - 5 years, taking 

into account public comment and the need for additional reviews for reformulation and 

compliance.

81
I. By the time of the five-year sunset period, the NOSB will approach a review of those on 

the 25b list. 

Recommended Subcommittee Action & Vote (state actual motion):

Motion:

To adopt the proposed Policy and Procedure Proposal on Other (“Inert”) Ingredients in 

Pesticide Formulations on the National List. 

Motion by: Colehour Bondera Second: Jay Feldman 

Yes__8___ No__0__ Abstain__0__ Absent__0__ Recuse__0__

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 22, 2012

Appendix A – Inerts Screen 

(Modified from NOSB proposal of 2010)

(1) Toxicity Category I or II by the United States Environmental Protection Agency (EPA). 

These pesticides are identified by the words “DANGER” or “WARNING” on the label.

 

(2) A developmental or reproductive toxicant as defined by the State of California Proposition 

65 Chemicals Known to Developmental or Reproductive Harm.

(3) A carcinogen, as designated by EPA’s List of Chemicals Evaluated for Carcinogenic 

Potential (chemicals classified as a human carcinogen, likely to be carcinogenic to humans, a 

known/likely carcinogen, a probable human carcinogen, or a possible human carcinogen), the 

International Agency for Research on Cancer (IARC), U.S. National Toxicology Program 

(NTP), and the state of California's Proposition 65 list. Any of the following classifications shall 

deem the chemical a carcinogen and unacceptable:

Known to the State of California to Cause Cancer (California) 

http://www.oehha.org/prop65/prop65_list/Newlist.html 

Group A: Human Carcinogen (US EPA 1986 category) 

http://npic.orst.edu/chemicals_evaluated.pdf : 

http://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1:613774867565701 

Group C: Possible Human Carcinogen (US EPA 1986 category)

Known Carcinogen (US EPA 1996 category)

Likely Carcinogen (US EPA 1996 category)

Carcinogenic to Humans (US EPA 1999 category)

Likely to be Carcinogenic to Humans (US EPA 1999 category)

Suggestive Evidence of Carcinogenicity (US EPA 1999 category)

Known to be Human Carcinogens (NTP) http://ntp.niehs.nih.gov/?objectid=03C9F0A4-

B1C2-31DE-ABA8508AE9949C57 

Reasonably Anticipated to be Human Carcinogens (NTP) 

82
Group 1: Carcinogenic to Humans (IARC) 

http://monographs.iarc.fr/ENG/Classification/index.php 

Group 2A: Probably Carcinogenic to Humans (IARC)

Group 2B: Possibly Carcinogenic to Humans (IARC)

(4) Nervous system toxicants, including chemicals such as cholinesterase inhibitors or 

chemicals associated with neurotoxicity by a mechanism other than cholinesterase inhibition, 

or listed on:

Toxics Release Inventory (TRI), EPA EPCRA Section 313 (Identified as "NEUR" on 

Table 1) http://www.epa.gov/tri/trichemicals/hazardinfo/hazard_chronic_noncancer95.pdf 

EPA Reregistration Eligibility Decisions (RED) 

http://iaspub.epa.gov/apex/pesticides/f?p=chemicalsearch:1:613774867565701 

Insecticide Resistance Action Committee (IRAC) Mode of Action Classification: 

http://www.irac-online.org/eClassification/ 

Acetylcholine esterase inhibitors;

GABA-gated chloride channel antagonists;

Sodium channel modulators;

Nicotinic Acetylcholine receptor agonists /antagonists;

Nicotinic Acetylcholine receptor agonists;

Chloride channel activators;

Octopaminergic agonists;

Voltage-dependent sodium channel blockers; or

Neuronal inhibitors (unknown mode of action).

California Department of Pesticide Regulation or the Materials Safety Data Sheet 

(MSDS) designations for cholinterase inhibitors

(5) Endocrine disruptors, which include chemicals that are known to or likely to interfere with 

the endocrine system in humans or wildlife, based on the European Commission (EC) List of 

146 substances with endocrine disruption classifications, Annex 13 (and/or any subsequent 

lists issued as follow-up, revisions, or extensions). 

http://ec.europa.eu/environment/docum/pdf/bkh_annex_13.pdf or 

http://ec.europa.eu/environment/endocrine/strategy/substances_en.htm#report2 

(6) (Regarding outdoor use) Adversely affects the environment/wildlife, based on:

1. Label precautionary statements including “toxic” or “extremely toxic” to bees, birds, 

fish, aquatic invertebrates, wildlife or other non-target organisms, unless these 

organisms are the target pest and/or environmental exposure can be virtually 

eliminated.

2. Pesticides with ingredients with moderate or high mobility in soil, according to the 

Groundwater Ubiquity Score (GUS), or with a soil half-life of 30 days or more (except for 

mineral products). Persistence and Soil Mobility procedures appear below.

a) If GUS (Groundwater Ubiquity Score) cannot be found, we search for the aerobic soil 

half-life and soil-binding coefficient Koc. GUS is then calculated from the formula: GUS 

= log10(half-life)*(4 – log10 (Koc)).

(7) Has data gap or missing information in EPA registration documents, including pesticide fact 

sheets, or EPA reregistration eligibility decisions, which EPA is requiring the registrant to fulfill.

83
(8) Contaminants and metabolites recognized by EPA that violate any of the above criteria. 

(9) Known groundwater contaminants, as designated by the state of California (for actively 

registered pesticides) or from historic groundwater monitoring records. 

84
National Organic Standards Board

Crops Subcommittee

Proposal to Add Rotenone to National List 205.602

as a Prohibited Natural Substance

August 7, 2012

Introduction

The NOSB Crops Subcommittee acknowledges the intent and validity of the portion of the 

Organic Foods Production Act (OFPA) that calls for a Special Review of Botanical Pesticides 

prior to the establishment of the National List [2119(k)(4)]. We wish at this time to re-review the 

botanical pesticide Rotenone and add it to the National List section 205.602 as a Prohibited 

Natural substance.

Background

The NOSB conducted its Special Review of Botanical Pesticides during their meeting that ran 

from October 10 to 14, 1994. As stipulated in OFPA (below) it was before the National List was 

established. The Rotenone portion of the minutes is quoted below (from lines 851 to 874 of the 

official minutes). The references used in the special review in 1994 are cited at the end of this 

recommendation.

Brown reported on the low LD50 of rotenone when tested on rats, its toxicity to fish 

and birds and on no records of fatalities or poisonings in humans. Kinsman reported 

that it is used widely for lice, mange and mites in conventional production. John 

clarified that the Board is reviewing the natural ground root and not synthetic 

preparations or the synthetic extracted form of rotenone. Theuer offered that the halflife of rotenone is long and the required 24 hour withdrawal time may not be long 

enough and that there are many alternatives. Brian Baker stated that rotenone is 

restricted in its applications by private certifiers and that the California Senate 

repealed its registration because of incomplete information and not because of health 

reasons. Merrill Clark requested that the Board take actions to move production away 

from the use of all botanicals by considering a phase out of all botanicals. David 

Haehn spoke to its usefulness in livestock and aquaculture. Brian Baker informed the 

members that rotenone has been debated within the organic community for years

and despite its shortcomings a data gaps, there are no alternatives because of the 

natural/synthetic rule.

Quinn moved and Kinsman seconded to place rotenone on the prohibited natural list. 

VOTE Yes - 1. Opposed - 8. Abstain - 4. Failed. Rotenone is kept off the list of prohibited 

natural substances."

The NOSB and the Secretary have the clear authority to prohibit specific natural substances 

(see below rule sections). Since 1994 a large amount of information has emerged from 

research that showed harmful effects of rotenone on the human system, leading to Parkinsons' 

disease and other health problems. 

Rotenone Regulatory History

In March and April 2006, registrants of rotenone in the U.S. requested voluntarily 

cancellation from the U.S. Environmental Protection Agency (EPA) of all livestock, 

85
residential and home owner uses, domestic pet uses, and all other uses except for 

piscicide uses. A data call-in was issued in 2004 requiring a sub-chronic (28-day) 

inhalation neurotoxicity study to further investigate the results of independent studies in 

animals that led to Parkinson’s Disease-like symptoms. At the time the study was 

required, rotenone had registered uses for dust products in agricultural and residential 

settings which were of particular concern for inhalation exposure. However, when all 

agricultural and residential uses, and all food uses were voluntarily cancelled in 2006, 

this requirement was waived. In July 2006, EPA issued its “Report of the Food Quality 

Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management 

Decision (TRED)” in which the agency indicated its intent to revoke the three tolerance 

exemptions for rotenone.

The Registration Eligibility Decision (RED) was completed in 2007. The RED approved 

piscicidal uses granting that additional personal protective equipment (PPE) including 

respiratory protection will be required for all remaining uses. However, EPA states that it 

“cannot quantitatively asses a potentially critical effect (neurotoxicity) at doses to which 

rotenone users could be exposed; therefore, an additional 10x database uncertainty 

factor has been applied.”

Remaining rotenone products are classified as Restricted Use Pesticides (RUP) due to 

acute inhalation, acute oral, and aquatic toxicity. According to EPA, “rotenone is applied 

directly to water to manage fish populations in lakes, ponds, reservoirs, rivers, streams, 

and in aquaculture. The chemical can be applied to an entire water body to achieve a 

“complete kill” or to a portion of a water body to achieve a “partial kill.” Complete kills 

are used to eliminate all fish in the treatment area; partial kills are used to reduce or 

sample fish populations in the treatment area.” (Source: USEPA. 2007. Reregistration 

Eligibility Decision (RED) Document. Office of Pesticide Programs. Washinton DC. 

http://www.epa.gov/oppsrrd1/reregistration/REDs/rotenone_red.pdf) 

Updating the National List

While rotenone has been voluntarily cancelled by the manufacturer and its agricultural 

use is phasing out in the United States, a search of the internet in 2012 shows that 

rotenone products are still available in other countries. Because of this, and because 

certifiers, farmers other people involved with organic production are still getting 

questions from the public about rotenone, board action is needed to clarify the situation 

by listing rotenone as a prohibited nonsynthetic.

Therefore, the NOSB has re-reviewed this particular botanical pesticide and 

recommends to the Secretary that it be placed on §205.602 as a prohibited natural 

substance for organic agriculture. The subsequent checklist and list of references 

documents the basis for the recommendation.

Relevant areas in the Rule

OFPA 

Sec 2118 National List (c) Guidelines for Prohibitions or Exemptions – 

(2) Prohibition on the use of Specific Natural Substances 

(A) the Secretary determines, in consultation with the Secretary of Health and Human 

Services and the Administrator of the Environmental Protection Agency, that the use of 

such substances 

86
(i) would be harmful to human health or the environment; 

Sec 2118 National List (e) Sunset Provision – 

No exemptions or prohibition contained in the National List shall be valid unless the 

National Organic Standards Board has reviewed such exemption or prohibition as 

provided in this section within 5 years of such exemption or prohibition being adopted or 

reviewed and the Secretary has renewed such exemption or prohibition.

Sec 2119 National Organic Standards Board (k) Responsibilities of the Board – 

(4) Special Review of Botanical Pesticides. The Board shall, prior to the 

establishment of the National List, review all botanical pesticides used in agricultural 

production and consider whether any such botanical pesticides should be included in 

the list of prohibited natural substances." 

(l) Requirements – ....the Board shall – 

(1) review available information from the Environmental Protection Agency....., 

concerning the potential for adverse human and environmental effects of substances 

considered for inclusion in the proposed National List.

Discussion

The Crops Subcommittee believes that the data indicating harm to human health precipitated 

the removal of rotenone from the market. Therefore only the checklist for Category 1 is 

presented here based on the NOSB's own literature review conducted in 2012. The negative 

results in category 1 are sufficient for prohibition so that the other categories are not evaluated 

at this time.

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: [1,2,3] 

Subcommittee Comments:

Adverse environmental and health impacts, lack of essentiality, and incompatibility with organic 

principles, as supported by the TR and checklist.

Proposed Annotation (if any): 

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

Notes: 

Recommended Subcommittee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: 

87
Rotenone is a natural substance.

Motion by: Harold Austin Second: Barry Flamm

Yes__6___ No__0__ Abstain__0__ Recuse__0__ Absent__2 _ 

Listing Motion: 

To add Rotenone to the National List 205.602 as a Prohibited Natural Substance.

Motion By: Harold Austin Second: Barry Flamm

Yes__6___ No__0__ Abstain__0__ Recuse__0__ Absent__2 _ 

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. 601(h) 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: 

4

Substance was recommended to be deferred because 

 

If follow-up needed, who will follow up: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 7, 2012

NOSB Evaluation Criteria for Substances Added To the National List

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

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 improper use in agriculture can cause 

the death of fish in nearby water.

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X

88
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 no registered products in the U.S.

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 see fish references and comment.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X unknown for livestock or crops, but

effects on humans may be 

transferrable to livestock.

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? [§6518 m.2]

X see #10 below

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 Rotenone inhibits mitochondrial 

function and has been highly 

correlated with Parkinsons disease 

(Tanner, 2011). Tanner's study is 

highly important because it was based 

on a human population from the 

Farming and Movement Evaluation 

study (FAME), nested in the 

Agricultural Health Study, of 84,740 

private pesticide applicators (mostly 

farmers) (Alavanja, 1996; Blair, 2002) 

Rotenone has also been linked to 

other central nervous system 

pathology (Greene, 2009).

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

2012 References Cited:

89
Alavanja MC, Sandler DP, McMaster SB, Zahm SH, McDonnell CJ, Lynch CF, et al. 1996. The 

Agricultural Health Study. Environ Health Perspect 104:362–369

Arizona Game and Fish Department 2010. Rotenone - Frequently Asked Questions. 

http://www.azgfd.gov/h_f/documents/ROTENONE%20FAQ%20committee%20final%20report

%20section%201-6-12.pdf

Beyond Pesticides 1987. Safety Source for Pest Management - Beyond Pesticides Least Toxic 

Service Directory – Rotenone. 

http://www.beyondpesticides.org/infoservices/pesticidefactsheets/toxic/ROTENONE.HTM

Blair A, Tarone R, Sandler D, Lynch CF, Rowland A, Wintersteen W, et al. 2002. Reliability of 

reporting on life- style and agricultural factors by a sample of participants in the Agricultural 

Health Study from Iowa. Epidemiology 13(1):94–99.

Center for Disease Control and Prevention 2010 - NIOSH Pocket Guide to Chemical Hazards

Rotenone. http://www.cdc.gov/niosh/npg/npgd0548.html

Chameides, Bill 2011. The Pesticide Rotenone: On the Shelf Instead of Shelved. 

http://www.nicholas.duke.edu/thegreengrok/rotenone

Greene JG, Noorian AR, Srinivasan S. 2009. Delayed gastric emptying and enteric nervous 

system dysfunction in the rotenone model of Parkinson’s disease. Exp Neurol 218(1):154–161.

NOSB (National Organic Standards Board) 1994. Minutes from the NOSB meeting in October 

1994 in Rohnert Park, CA. Available at: 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057495

Rotenone Fact Sheet (MSDS) 2008. http://datasheets.scbt.com/sc-203242.pdf

Tamm, Dr. Lucius, et. al. 2000. Use of Rotenone in Organic Agriculture: FiBL Statement -

Noevember 2000 Research Institut of Organic Agriculture, Ackerstrasse, CH-5070 Frick. 

http://www.pmac.net/rotenone.pdf

Tanner CM, Kamel F, Ross GW, Hoppin JA, Goldman SM, et al. 2011. Rotenone, Paraquat, 

and Parkinson’s Disease. Environ Health Perspect 119(6): doi:10.1289/ehp.1002839

US Environmental Protection Agency (EPA) 2010. EPA-HQ-OPP-2005-0494-0066 Rotenone; 

Notice of Receipt of Requests to Voluntarily Cancel Pesticide Registrations. Federal Register

Vol. 75, No. 144, July 28, 2010.

US Environmental Protection Agency (EPA) 2007. EPA 738-R-07-005 Reregistration Eligibility 

Decision for Rotenone. http://www.epa.gov/oppsrrd1/REDs/rotenone_red.pdf

1994 References Used in NOSB Review (Selected)

EXTONET Oregon State University. 1989. Rotenone

90
Newsome, Wm.H, and J.B. Shields 1980. Residues of Rotenone and Rotenolone on Lettuce 

and Tomato Fruit after Treatment in the Field with Rotenone Formulations. American 

Chemical Society 0021-8561/80/1428-0722

Worthing, Charles, and R. Hance 1968. The Pesticide Manual, 9th ed. British Crop Protection 

Council.

NOSB (National Organic Standards Board) 1994. Papers used in the Special Review of 

Botanicals at the NOSB meeting in October 1994 in Rohnert Park, CA. Beyond citations here 

there was a TAP review from James Johnson, letter from Bart Hall-Beyer of ATTRA, an 

Agricola Search of citations, MSDS, and several Rotenone Fact Sheets (not well attributed). 

91
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Sulfuric Acid

August 7, 2012

Introduction:

A petition was submitted requesting the addition of sulfuric acid to the National List (7 CFR 

§205.601) for stabilization of digested poultry manure to a pH under 4.5 but not below 3.5.

Background:

In 2006, a similar petition was submitted for use in digested livestock manure. The Crops 

Committee voted unanimously to reject the petition because “Sulfuric acid, when used in 

livestock manure, is changed to sulfate, which is in this case a synthetically derived plant 

nutrient. Additionally, it is an important air pollutant, e.g. acid rain. Other wholly natural 

materials can be used.” After some discussion by the NOSB at the October 18, 2006 meeting, 

and at the request of the petitioner, the vote on the petition was deferred.

Discussion:

The listing of sulfuric acid is not the only hurdle that petitioners need to clear in order to use 

their products. OMRI so far restricts the use of byproducts of anaerobic digestion of animal 

manures --used for generating methane-- to the uses allowed for raw manure. They say that 

these byproducts do not meet the NOP temperature and moisture criteria for processed 

manure. (They also do not contain the beneficial aerobic organisms that are an important 

benefit to the soil from composted manure.) Additional action by the NOSB and/or NOP will be 

needed to allow the full use of anaerobically-digested waste. (OMRI Materials Review, 

Summer 2012)

The Crops Subcommittee agrees with the 2006 vote and recommends denying the petition 

because of adverse environmental and health impacts, lack of essentiality, and incompatibility 

with organic principles, as supported by the checklist.

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: [1,2,3] 

Subcommittee Comments: 

Adverse environmental and health impacts, lack of essentiality, and incompatibility with organic 

principles, as supported by the TR and checklist.

92
Recommended Subcommittee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: 

Sulfuric Acid is synthetic.

Motion by: Colehour Bondera Seconded by: Nick Maravell 

Yes__6___ No__0__ Abstain__0__ Recuse__0__ Absent__2__

Listing Motion: 

To list on §205.601, sulfuric acid for stabilization of digested poultry manure to a pH under 

4.5 but not below 3.5.

Motion by: Harold Austin Second: Barry Flamm

Yes__0___ No__6__ Abstain__0__ Recuse__0__ Absent__2 _ 

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. 601(h) 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: 

4

Substance was recommended to be deferred because 

 

If follow-up needed, who will follow up: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 7, 2012

93
NOSB Evaluation Criteria for Substances Added To the National List

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

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 

2. Is there environmental 

contamination during 

manufacture, use, misuse, or 

disposal? [§6518 m.3]

X 

One of the primary sources of human sourced sulfuric 

acid in the environment is its manufacture. (TR, lines 

187-191) According to the TRI, in 1996, releases of 

sulfuric acid to the air from 7 14 large processing 

facilities totaled 8,929,868 kg (19,690,359 pounds) 

(TR196 1998). (ATSDR, 1998. Toxicological Profile for 

Sulfur Trioxide and Sulfuric Acid. 

http://www.atsdr.cdc.gov/toxprofiles/tp117.pdf.)

3. Is the substance harmful to 

the environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X 

Sulfuric acid can kill organisms. Air borne sulfuric acid 

can cause pulmonary edema (TR lines 187-200 & lines 

234-242 & lines 296-297) If sulfuric acid comes in 

contact with bodies of water the bioavailability of heavy 

metals increases. (Ostiguy). The International Agency 

for Cancer Research (IARC) has determined that there 

is sufficient evidence that occupational exposure to 

strong-inorganic-acid mists containing sulfuric acid is 

carcinogenic to humans (IARC 1992, 1997). (TR lines 

313-316)

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 

Sulfuric acid can interact with other chemicals used if it 

comes in contact with the other materials. (TR lines 

187-191) Sulfuric acid, when used as a pH adjustor for 

livestock manure, is changed to sulfate, which is plant 

nutrient. (TR lines 226-227) Sulfuric acid is corrosive..

6. Are there adverse biological 

and chemical interactions in 

agro-ecosystem? [§6518 m.5]

X Sulfuric acid, when used in livestock manure, is 

changed to sulfate. (TR lines 226-227)..

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

X 

Sulfuric acid is corrosive and, at high concentrations, 

can kill organisms. No detrimental physiological effects 

on soil organisms, crops or livestock are expected for 

this usage. Detrimental impacts from manufacture, 

misuse, disposal. (TR lines 178-229) 

8. Is there a toxic or other 

adverse action of the material 

or its breakdown 

products?[§6518 m.2]

X 

Sulfuric acid is corrosive; it can harm eyes, skin, and 

respiratory and gastrointestinal tracts. (TR lines 294-

308.) . The International Agency for Cancer Research 

(IARC) has determined that there is sufficient evidence 

that occupational exposure to strong-inorganic-acid 

mists containing sulfuric acid is carcinogenic to humans 

94
(IARC 1992, 1997). (TR lines 313-316) ). (ATSDR, 

1998. Toxicological Profile for Sulfur Trioxide and 

Sulfuric Acid. 

http://www.atsdr.cdc.gov/toxprofiles/tp117.pdf.)

9. Is there undesirable 

persistence or concentration of 

the material or breakdown 

products in 

environment?[§6518 m.2]

X 

Sulfuric acid is not persistent. Its breakdown products 

are sulfate ions. It can persist in the environment if the 

soil is unable to neutralize it. (TR lines 330-341)..

10. Are there any harmful 

effects on human health? 

[§6517 c (1)(A)(i) ; 6517 

c(2)(A)i; §6518 m.4]

X 

Skin, eye respiratory and gastrointestinal tract irritation; 

EPA Category I toxicity; aerosol is a suspected human 

carcinogen (ACGIH); H2SO4 mist is a human 

carcinogen (IARC); protective clothing, eyewear & 

breathing protection are needed (TR lines 294-325). 

Sulfuric acid exposure also occurs when it is 

manufactured... The National Occupational Exposure 

Survey (NOES), conducted by NIOSH from 1981 to 

1983, estimated that 56,103 and 775,348 U.S. workers 

may be exposed to sulfur trioxide and sulfuric acid, 

respectively (NOES 1990).”

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.

95
Category 2. Is the Substance Essential for Organic Production? Substance _ Sulfuric Acid _ 

Question Yes No N/A1 Documentation

(TR; petition; regulatory agency; other)

1. Is there a natural source of 

the substance? [§205.600 b.1]

X

2. Is there an organic 

substitute? [§205.600 b.1]

X

3. Is the substance essential 

for handling of organically 

produced agricultural 

products? [§205.600 b.6]

X 

4. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

X 

At present, the quantity of carbon material required to 

induce a significant pH decline is economically 

prohibitive. However, if the production of acid can be 

optimized, possibly by using suitable lactic acid 

bacteria, it would offer an effective and safe means to 

prevent ammonia production. (TR367-369) A variety of 

natural absorbents can be used to reduce ammonia 

production; some of the most commonly employed are 

peat and clinoptilolite (a naturally occurring aluminosilicate mineral with high cation exchange capacities). 

The advantages associated with the use of either 

clinoptilolite or peat are that they are nonhazardous and 

act as good soil conditioners when spread with manure. 

(TR371-374)

5. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

X 

6. Is there any alternative 

substances? [§6518 m.6] X 

Unreacted carbon, citric acid, lactic acid bacteria or 

materials such as clay, peat, and clinoptilote. (TR lines 

356-387). 

7. Is there another practice 

that would make the 

substance unnecessary? 

[§6518 m.6]

X 

Composting animal manure can also be used. 

Stabilization of animal manures can also be accomplish 

with unreacted carbon, lactic acid bacteria or materials 

such as clay, peat, and clinoptilote.(TR lines 356-387) 

Other types of approved composted materials and 

dehydrated manure can be used. ). Hall and Sullivan 

(2001) provide a review of alternative soil amendments 

to agricultural fertilizers and manure, including several 

that can be considered wholly natural, such as various 

plant byproducts (e.g., composted leaves), rock and 

mineral powders (e.g., granite dust), and seaweed 

products. (TR382-387) As specified under NOP 

§205.203(b): “The producer must manage crop 

nutrients and soil fertility through rotations, cover crops, 

and the application of plant and animal materials.” 

Thus, the need to use manure (whether composted, 

non-composted, or chemically-treated) or plant 

materials could be replaced through crop rotation and 

96
use of cover crops. (TR 409-412)

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.

97
Category 3. Is the substance compatible with organic production practices? 

Substance __ Sulfuric Acid __

Question Yes No N/A1 Documentation

(TR; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? 

[§205.600 b.2]

X 

2. Is the substance consistent 

with organic farming and 

handling? [§6517 c (1)(A)(iii); 

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

X Sulfuric acid is the primary agent of acid rain, it is an air 

pollutant TR lines 46-50) Sulfuric acid, when used in 

livestock manure, is changed to sulfate, which is in this 

case a synthetically derived plant nutrient.TR lines 226-

227). It has been allowed in similar uses for materials 

presently on the National List.

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

X Sulfuric acid is the primary agent of acid rain, it is an air 

pollutant TR lines 46-50) Sulfuric acid, when used in 

livestock manure, is changed to sulfate, which is in this 

case a synthetically derived plant nutrient. TR lines 

226-227) It has been allowed in similar uses for 

materials presently on the National List.

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 

Sulfur compounds.

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 

98
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.

2006 recommendation: “Describe why material was rejected: Sulfuric acid, when used in animal 

manure, is changed to sulfate, which is in this case a synthetically derived plant nutrient. Additionally, it 

is an important air pollutant, e.g., acid rain. Other wholly natural materials can be used. (See Category 

2, questions 4, 6, and 7.”

99
100
National Organic Standards Board

Materials Subcommittee

Proposal: Research Priorities for 2012

August 17, 2012

Introduction

A Recommendation for a Framework to Establish Research Priorities was 

approved at the last National Organic Standards Board (NOSB) meeting in May 

2012. Part of that recommendation was that the priorities from the previous year 

of NOSB deliberations would be presented at each fall meeting. Therefore, we 

have collected suggested research topics from the NOSB subcommittees and 

from suggestions within the public comments and will present the top research 

priorities for approval this fall.

After a recommendation is finalized by the NOSB each fall the Chair of the Board 

will make sure it is sent to the primary organic research funders such as NIFA, 

ARS, NRCS, OFRF, and private foundations and other funders that may be 

identified. In addition all NOP staff, NOSB members and stakeholders can use 

the list for inspiring appropriate research.

Background

The reasons for encouraging research into organic production systems are well 

discussed in the previous two Materials Committee papers from fall 2011 and 

spring 2012. 

The recommendation that was passed recommends that potential topics be 

prioritized. The criteria for prioritization are for those topics that the NOSB 

believes will have the largest long-term impact on growth and integrity of organic 

agriculture. These criteria are not presented in order of importance, but are 

evaluated by the Materials Subcommittee in selecting the top research needs. 

Criteria for research topics are:

• Persistent and chronic (i.e., perennial topics of debate and need)

• Challenging

• Controversial (i.e., topics on which there are widely differing perspectives 

or for which there have been close NOSB votes)

• Nebulous (i.e., the research need is hard to identify but the organic 

agriculture need is clear). For example, improved methods of weed 

control.

• Lacking in primary research. That is, topics for which there is no active 

research being conducted, primarily relating to the criteria in OFPA for 

review of materials.

• Relevant to assessing the need for alternative cultural, biological, and 

mechanical methods to materials on the National List.

101
Call for Researchers

We hope that this information will be useful for researchers in many fields to 

defend and solicit funds for research that benefits organic production and 

handling. Therefore we invite the public to comment on these topics, to circulate 

this widely, and to recommend that funders also prioritize these topics. Please 

submit comment on which funding agencies should be informed of research 

needs for organics.

NOSB Research Priorities and issues of concern: 

Several important topics have been identified and must be applied within an

organic context. Research and evaluation of these and interrelated issues are

urgently needed.

 Whole Farm Systems Research 

How can working with the natural world by including diversity of habitat, 

cropping systems, and biological life benefit an organic farm?

• Can crop species and varieties be specifically adapted to their site through 

plant breeding or cultural practices?

• How does biodiversity contribute to pest and disease resistance?

• What is the relationship between nutrient balancing fertilization practices 

and microbial life in the soil and susceptibility or resistance to pests?

• How can the need for a diverse ecological system be balanced with food 

safety concerns for a sustainable organic farming system?

• How can the complex whole environmental system inform, support and 

educate a farmer in developing a farming system plan?

 Evaluation of Copper Sulfate for Rice (Sunset Review)

In the timeframe that CuSO4 is used in the field, 5 to 15 days after 

planting, are there documented effects on other organisms in the rice 

fields (frogs, fish, insects, etc.)?

• What are the obstacles or opportunities for the use of sodium carbonate 

peroxyhydrate as an alternative to copper sulfate? Evaluate both 

agronomic and market issues.

• Can the build-up of copper in rice fields be mitigated with other minerals 

such as Calcium or Magnesium?

• Are there biological control alternatives for algae control in rice, such as 

viruses or organisms that consume algae?

• Can drill-seeding techniques be adapted so that they can be a viable 

alternative to product rice without copper sulfate?

102
 Evaluation of Antibiotics (Tetracycline and Streptomycin 

alternatives)

What are the elements that are considered in an organic systems plan that 

avoids the use of antibiotics? 

(Please address any or all of the following and their relative importance: 

location, planting density, choice of varieties of cultivar and rootstock, 

diversity of cultivars in orchard and region, diversity of crops in farm and 

region, soil improvement practices, pruning practices and general 

sanitation, groundcovers or intercrops, pollinator management, other 

preventive or general orchard management practices, dormant copper 

sprays, bloom thinning/lime sulfur, early bloom sprays to prevent stigma 

colonization by fire blight bacteria, full and late bloom sprays to protect the 

floral cup, surveys for fire blight activity, computer models, others.)

• Is there any new technology that can aid organic growers in determining 

potential fire blight infection periods? (Detection models, in field sampling, 

etc) 

• What are the impacts of geographic locations on the severity of fire blight 

and control programs?

• What materials could be potential replacements for the antibiotics as part 

of a comprehensive fire blight control and management component of an 

Organic Farm Plan? What time frame before they would be commercially 

available? What are the pros and cons of these materials? 

 Evaluation of Genetically Modified Vaccines (GMO)

GMO prevention and unintended GMO contamination are foundational to 

organic production and brand. It is of such importance that NOSB has a 

GMO Ad-Hoc Subcommittee. GMO free is a major selling point of organic 

commodities to consumers. 

• A need exists for research and/or outreach on easier ways to 

determine the types of vaccines. A better way of identifying the types 

of vaccines is critically important to our stakeholders, especially 

livestock producers. The testing of products that could be alternatives 

to GMO vaccines in livestock production is a top priority. 

103
 Organic Aquaculture

Organic aquaculture is on the rise. One report has shown that organic 

aquaculture generated over 30 billion dollars in 2006. It is said to be the 

fastest growing organic sector in the world according to another source. 

There is a great debate as to whether organic aquaculture should be 

approved for open, closed, or both in the United States. Therefore, 

research efforts pertaining to open and closed systems seem warranted in 

some cases. 

• Research is needed or data located regarding the impact of fish waste 

water on the environment, and feed and other materials used (100% 

organic, fish by-products, synthetic nutrients, etc.). Waste management, 

fish health (diseases and parasites), fish escapes in open and closed 

systems need to be explored. 

 Methionine Alternative

Methionine is an essential amino acid for poultry. Prior to the 1950’s 

poultry and pigs were fed a plant and meat based diet without synthetic 

amino acids such as methionine. One former NOSB member stated, in 

§205.237(5) (b), “We have seemingly made vegetarians out of poultry and 

pigs”. As the organic community moves toward reducing, removing, or 

providing additional annotations to synthetic methionine in the diets of 

poultry, a heighten need exists for the organic community to rally around 

omnivore producers to assist in marshaling our collective efforts in finding 

viable alternatives to synthetic methionine and help find approaches for 

making them more commercially available. 

• Research on alternatives such as herbal methionine, corn gluten meal, 

potato meal, management practices, pastures management, fish meals, 

animal by-products, and other non-plant materials, needs to be explored 

as an alternative to synthetic methionine. 

• Research on the use of natural herbal methionine seemingly is showing 

great potential. It could possibly replace synthetic methionine at a rate of 

1:1. However, more research is needed. 

 Carrageenan 

• Can Carrageenan be produced using methods that are non-synthetic

and can those methods be used for all the types of carrageenan?

• Does the gel formed by carrageenan when it is used in food provoke an 

inflammation response? Injected or in vitro studies allegedly cannot be 

104
compared to feeding studies because the carrageenan has formed a gel 

that is more resistant to degradation in food.

• Is there replicated proof that carrageenan breaks down into smaller

molecular weight forms in digestion and that these forms are small

enough and populous enough to pose a health concern?

• Allergic and toxicological responses to carrageenan are so far

primarily anecdotal. Can there be further research done to quantify how 

widespread and truthful these claims are?

• Are there viable alternatives to carrageenan and if so, for what uses?

Other Topics for Future Review:

• Parasitism

 The control of internal and external parasites is important to 

animal welfare, growth, reproduction, and production. In 

organic production, the control of parasites is critical. The 

use of antibiotics is prohibited. A limited number of 

substances are available to control parasites. Antibiotics are 

not allowed in organic livestock production for growth, 

reproduction, and production. Antibiotics can be used on sick 

animals. However, these animals cannot be sold as organic. 

A critical need exists to explore ways to find materials for the 

control of internal and external parasites in organic livestock 

operations. 

• Mastitis

 Mastitis is a disease of the mammary gland. It is an 

inflammation in the mammary gland. It is generally 

associated with dairy cattle. It can be caused by bacteria, 

physical injury, etc. Mastitis is one of the most common and 

expensive diseases of dairy cattle. It can result in reduced 

milk production, discarded milk, treatment, and veterinary 

expenses. An urgent need exists for looking at ways to 

reduce mastitis in dairy herds. The research needs include 

the areas of herbal treatment of mastitis and management 

practices. 

• Herd Health

 The assessment of preventive organic practices to improve 

organic livestock health is critical and of high importance. 

These include general animal health as it relates to diseases 

prevention, uterine infections in peri-parturient animals, 

growth, and identification of vaccine types, nutrition, and 

production systems. 

105
• Plant Extract

 Plant extracts that could be environmentally and 

economically beneficial to organically control methane 

producing bacteria in the animal could lead to practices that 

reduce methane. Reduced methane results in more energy 

going to the animal from a given amount of feed. This 

reduces total feed required to meet nutritional needs and 

particularly helps grazing animals that have high protein 

availability from pasture, but low energy. Research in this 

area could be economically significant. 

Subcommittee Vote

Motion to adopt the proposal on NOSB Research Priorities.

Motion by: Zea Sonnabend Second: Calvin Walker

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

106
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Ascorbyl Palmitate

August 14, 2012

Summary of Proposed Action:

Ascorbyl palmitate (AP) is a synthetic ester of ascorbic acid and palmitic acid used in 

infant formula as a preservative. FDA lists it as GRAS. Ascorbyl Palmitate has 

antioxidant properties, but, as the TR states “ it remains inconclusive whether or not the 

body actually utilizes ascorbic acid that is metabolized from AP”.

Ascorbyl palmitate has some advantages as a food preservative because it is fat 

soluble and very slightly water soluble. AP synergistically improves the effectiveness of 

other preservatives, such as tocopherols, to protect fats and oils from rancidity and 

prevent rancid flavor. It is used in cosmetics, animal feeds and margarine to reduce 

rancidity (Petition page 2). Synthetic AP is currently used in infant formula to stabilize 

DHA and ARA edible oils. AP, DHA, and ARA are not required by FDA to be added to

infant formula. 

Use of AP for stabilizing edible oils raises the issue of a lack of an established policy on 

“other ingredients.” In December 2011 the NOSB approved use of DHA from Algal Oil 

and ARA from Fungal Oil, and specifically did not approve all the “other ingredients” 

(which included AP) for broad use in organic food. Approval was specific and explicitly 

not precedent setting, applying only to the petitioned formulations of DHA and ARA. 

Organic alternatives to Ascorbyl palmitate exist, especially rosemary extract and 

tocopherols. Synthetic tocopherols are also an alternative on the National List if organic 

rosemary extracts are not suitable. The Petition asserts that tocopherols are currently 

used in infant formulas, but have limited function without AP. Another alternative is to 

shorten shelf life date.

Agricultural organic alternatives to AP have not been evaluated for use in infant formula. 

The TR states, “Other organic agricultural fat-soluble antioxidants which may be 

potential alternative preservatives include, but are not limited to, alpha-tocopherol 

(vitamin E), beta-carotene, alpha-lipoic and dihydrolipoic acids, and ubiquinone. ... Like 

ascorbyl palmitate, ubiquinone and dihydrolipoic acid can function as synergistic 

antioxidants to regenerate tocopherols. No information was found to indicate whether 

or not these other fat-soluble antioxidants have been tested as alternatives to ascorbyl 

palmitate as preservatives in food or cosmetics, or are readily available for commercial 

use in processed foods.” 

According to the petitioner, certain organic alternative preservatives (carnosic acid from 

rosemary extract) could have effects harmful to pregnant mothers and unknown side 

effects in infants. No scientific data has been presented to show adverse effects or the 

107
relative degree of efficacy of using rosemary extract in infant formula. However, the 

NOSB recommendation approving DHA Algal Oil and ARA Fungal Oil recognized that 

rosemary extract was included in both materials. It must be noted that the Petition (page 

7) states “for infant formula rosemary extracts are not a suitable option” and further 

states that “rosemary extracts have not been tested and accepted for use in infant 

formula” and it is “not prudent to use these substances in food for young infants” 

(Petition, page 8). 

As reported by the Journal of the European Food Safety Authority (June 2008), a study 

in rats found no effect of rosemary extract on fetus development or on the ability of the 

fetus to reach full term. However, this same scientific opinion states, “The toxicological 

data on the rosemary extracts are insufficient to establish a numerical ADI [Acceptable 

Daily Intake], because the toxicity data set does not provide reproductive toxicity studies 

or a long term study. On the other hand, the existing data, including the absence of 

effects in the 90-day studies on reproductive organs and lack of genotoxicity, do not 

give reason for concern.”

Ascorbyl palmitate, as petitioned for use in “organic” infant formula, is not used to fortify 

food or add nutritional value.

AP is not listed for use as a preservative in organic infant formula in European, 

Canadian or Japanese standards. In European standards it appears that AP as vitamin 

C is permitted in organic infant formula to the extent it is required by infant formula 

directives on vitamins (although, as noted above, data is inconclusive on actual 

potential absorption of ascorbic acid from AP).

According to the TR, AP does not have significant adverse impacts on the environment 

or on human health, although it is noted in the Petition (page 5) that high levels of 

ascorbic acid increase oxalic acid production and excretion with potential for oxalate 

bladder stones.

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 ☐ Yes x☐ No ☐ N/A

3. Compatibility & Consistency ☐ Yes x☐ 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: [2 &3 ] Comments: 

Proposed Annotation (if any): 

108
Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐

Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: Ascorbyl palmitate (CAS 137-66-6) is synthetic.

Motion by: Nick Maravell Seconded by: Jean Richardson 

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

Listing Motion: To add Ascorbyl palmitate (CAS 137-66-6) to the National List sec 

205.605(b) for use as a preservative in infant formula.

Motion by: Nick Maravell Seconded by: Jean Richardson

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

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling x☐ Synthetic x☐ Rejected3 x☐

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 § 205.605(b). Describe 

why material was rejected: Ascorbyl palmitate (AP) is not required by FDA or other 

regulation to be added to infant formula. Permitted alternatives exist, including fat 

soluble ones, but none have been evaluated for use in infant processed foods. 

Objections to organic rosemary abstract are not supported by scientific data. DHA and 

ARA, already added to list, contain rosemary extracts. AP is a synthetic preservative 

and should not be added to the National List under restriction of 205.600(b)(4). 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

[John Foster], Committee Chair 8/14/12

109
NOSB Evaluation Criteria for Substances Added To the National List

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

Ascorbyl palmitate

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 TR

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 At high doses ascorbic acid 

increases oxalic acid production 

and excretion with potential for 

oxalate bladder stones (Petition, 

page 5)

11.Is there an adverse effect on 

human health as defined by 

x

110
applicable Federal regulations? 

[205.600 b.3]

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.

111
NOSB Evaluation Criteria for Substances Added To the National List

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

Ascorbyl palmitate

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 Petition; TR lines 227-234

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 Not the petitioned material.

3. Is the substance created by naturally 

occurring biological processes? 

[6502 (21)]

x

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

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 b.6]

x Shorter shelf life of product

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

x Natural alternatives, such as 

rosemary oil and extracts, for 

addition to infant formula have 

not been evaluated.

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 Tocopherols, derived from 

vegetable oils, and “only when 

rosemary extracts are not a 

suitable alternative” TR lines

124-125

10.Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

x Breast feeding. 

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.

112
NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: Ascorbyl palmitate 

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

x

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 TR (lines 317-318) states AP 

“is used as a preservative, which 

includes the prevention of offflavors or bad odors during shelf 

life of product”.

5. Is the primary use as a 

preservative? [§205.600 b.4]

x Petition and TR state; “The 

primary function of ascorbyl 

palmitate is as a preservative” 

(TR line 301)

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 Primary use is to prevent 

“development of off-flavors or bad 

odors that would otherwise occur 

over time” (TR line 303)

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

113
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.

114
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: Name Ascorbyl palmitate

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

regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic 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:

a. Regions of production 

(including factors such as 

climate and number of 

regions);

x

b. Number of suppliers and x

115
amount produced;

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.

116
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Synthetic Beta-Carotene

August 7, 2012

Summary of Proposed Action:

1. Petitioned for inclusion on 205.605(b) synthetic, non-agricultural addition to “organic” 

and “made with organic” ingredients

2. The synthetic version is what is being petitioned but there are natural versions of the 

ingredient on the market. Commercial availability may be a limiting factor.

3. The petition mentions for use in infant formula as a nutritional supplement and to 

prevent lipid components in the formula from going rancid (preservative) and as a 

colorant.

4. Beta-Carotene is necessary for proper development of retinas, and acts as an antioxidant, and in some cases as preservative.

5. Is considered GRAS as a food additive for nutrition. As a food colorant, it is exempt 

from certification (colors are not considered GRAS). 

6. B-C can be manufactured from a variety of processes including wholly chemical, 

from natural sources including fungi and algae, but these methods typically use toxic 

solvents. 

7. BASF is a key manufacturer of the ingredient

8. Commercially available manufacturing process utilizes toxic solvents and/or solvents 

that pose environmental risk to aquatic species if released. 

9. One method of manufacture uses relatively benign solvent made from soy and corn 

feedstuffs. 

10.Only one method from natural dehydrated carrots was discussed. 

11. B-C is not required for inclusion in infant formula, therefore the committee had 

concerns regarding the addition of a synthetic material that is not absolutely 

necessary.

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 ☐ Yes X 

No ☐ N/A 

as Organic (only for § 205.606)

117
Substance Fails Criteria Category: [ ] Comments: 

Proposed Annotation (if any): 

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

Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: Classify Beta-Carotene as petitioned as synthetic

Motion by: Tracy Favre Seconded by: Harold Austin

Yes: # 5 No: # 0 Absent: #2 Abstain: # 0 Recuse: # 0 

Listing Motion: Add Beta-Carotene as petitioned to 205.605(b) for use in infant 

formula.

Motion by: Tracy Favre Seconded by: Joe Dickson

Yes: # 0 No: # 5 Absent: # 2 Abstain: # 0 Recuse: # 0 

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling X Synthetic ☐ Rejected3 X

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: The committee was reluctant to approve the addition of 

a synthetic material that was not absolutely necessary. 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair August 7, 2012

118
NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? 

Substance: Synthetic Beta-Carotene

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 X 

Potential exists for environmental 

damage due to solvents used in 

the extraction process, which are

toxic to aquatic life

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X X 

The solvents used in the 

manufacturing process are not 

easily biodegraded and must be 

properly recycled, leading to 

potential for improper disposal or 

spillage. Under proper recycling 

there is no environmental 

contamination.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X X 

Could be harmful should solvents 

used in manufacturing be 

improperly disposed of

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]

Information not available

6. Are there adverse biological and 

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

X X See comments above regarding 

potential for environmental 

contamination

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X X See comments above regarding 

potential for environmental 

contamination

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.Are there any harmful effects on 

human health? [§6517 c (1)(A)(i); 

X X Some studies have linked betaCarotene with increases in lung 

119
6517 c(2)(A)i; §6518 m.4] cancer of smokers, but generally 

the effects of the ingredient are 

considered beneficial

11.Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X X See comments above

12.Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? 

[§205.600 b.5]

X When considered as a nutritional 

additive, when as a colorant 

GRAS is not applicable

13.Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X X The FDA has established residue 

limits for heavy metals but there 

is no evidence that contamination 

exists in the ingredient

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.

120
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? 

Substance: Synthetic Beta-Carotene

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 Per both the petition and TR, the 

ingredient is considered 

synthetically manufactured

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 X The most common formulation of 

the petitioned ingredient is wholly 

synthetic and is manufactured 

using a Confidential method, 

however there are other methods 

using solvent extraction from 

naturally occurring sources

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X The petitioned material is Synthetic 

Beta-Carotene

4. Is there a natural source of the 

substance? [§205.600 b.1]

X Beta-Carotene is widely available 

in red, orange and yellow fruits and 

vegetables, leafy greens, some 

types of fungus and algae

5. Is there an organic substitute? 

[§205.600 b.1]

X X Beta-Carotene can be extracted 

from plants using environmentally 

benign solvents from fermented 

corn and soybean feedstocks, but 

it is not clear whether this process 

would be considered organic

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

X X As a nutritional additive, BetaCarotene has unique anti-oxidant 

and preservative properties, but 

the use as a color additive could 

be replaced with alternatives such 

as organic annatto.

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

X Naturally derived Beta-Carotene is 

an alternate source, although 

commercial viability is an issue

8. Is the substance used in handling, 

not synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

X Beta-Carotene may be produced 

by extraction from some fungi and 

algae using solvents

9. Is there any alternative 

substances? 

[§6518 m.6]

X X Organic annatto could be used as 

a replacement for color additive, 

but would not address the anti121
oxidant and preservative properties 

of Beta-Carotene

10.Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

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.

122
NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: Synthetic Beta-Carotene

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X Synthetic Beta-Carotene is wholly 

synthetic manufactured from 

chemical compounds

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 Beta-Carotene is used as a 

nutritional substance as a 

precursor to Vitamin A

5. Is the primary use as a 

preservative? [§205.600 b.4]

X X Beta-Carotene is used as both a 

preservative of lipids (in infant 

formula, for instance) but also as 

nutritional supplement

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 A use of Beta-Carotene is as a 

coloring agent but the ingredient 

has other uses as described 

above

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, 

X

123
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.

124
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: Name Synthetic Beta-Carotene

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

regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic form of the material 

/substance is necessary for use in 

organic handling? 

X Neither the TR nor petition makes 

it clear as to why synthetic BetaCarotene is necessary over 

natural 

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 There is some discussion that 

there is only one naturally derived 

substitute that is commercially 

available.

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

125
b. Number of suppliers and 

amount produced;

X X Two suppliers are mentioned but 

no quantities are listed

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 X

d. Trade-related issues such as 

evidence of hoarding, war, 

trade barriers, or civil unrest 

that may temporarily restrict 

supplies; or

X 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.

126
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Lutein

July 17, 2012

Summary of Proposed Action:

Lutein (commonly referred to as xanthophyll) is a carotenoid, is related to betacarotene. It is a strong antioxidant, as well as a natural pigment. Lutein is present in 

many vegetables such as: spinach, kale, broccoli, and green peas. The petitioned 

Lutein is derived from dried food grade marigolds. This is the primary source of Lutein 

used as a coloring agent, food and livestock feed additive, and as a nutritional 

supplement. Lutein comprises the macular pigment of the eye and is found in the lens. It 

acts as a filter to blue light and serves an important role in eye health. All Lutein must be 

acquired through ones diet and cannot be synthesized by the body.

The primary source of Lutein for young infants is from human breast milk. The level of 

Lutein in human breast milk will vary depending on the dietary intake of Lutein rich 

vegetables by the infant’s mother. This will vary in different parts of the world due to 

cultural dietary eating habits. Cow milk or soy based infant formulas would need to be 

fortified with Lutein to equal the amounts normally found in human breast milk. 

This ingredient is not required by the FDA under 21 CFR 104.20(d)(3).

The petitioner has requested their product listed as Lutein- derived from marigold: 

(Tagetes erecta), and meeting the “Lutein” monograph established by the U.S. 

Pharmacopeia (“USP”) (when mixed with organic delivery ingredients including 

organic corn or safflower oil, and organic sugar and starch) as a listed substance 

pursuant to 7CFR 205.606, on the National List of Allowed and Prohibited Substances 

in the category of “Non-organically produced agricultural products allowed as 

ingredients in or on processed products labeled as ‘organic’”. They are requesting to 

list two specific uses of Lutein : (1) In organically labeled Infant Formula, (2) In 

organically labeled foods. The current petitioned source of Lutein is currently being used 

in organic handling. Because Lutein falls into the “accessory nutrients” category and 

was not one of the substances listed in 21CFR 104.20(d)(3) it is being petitioned for 

inclusion to the list of allowed substances. Because the actual method of producing 

Lutein is Confidential Business Information (CBI), the sub-committee could not verify 

that Lutein would be considered non-synthetic. Therefore the recommendation for 

classification of Lutein as petitioned is synthetic.

The Handling Sub-Committee was split on the listing of Lutein for use in infant formula. 

The basis of those voting in favor of listing it was that it currently is being used in some 

organic infant formulas and secondly because of the role it plays in the eye health of 

infants (and adults). Those on the sub-committee opposed to listing Lutein believe it is 

not a mandated additive by FDA for infant formula, did not have enough information in 

127
the CBI version of the petition to determine it to be non-synthetic, it does not appear to 

be “essential” since it is in some brands and not in others, and there appear to be viable 

non-synthetic alternatives such as whey protein and microalgae sources. The rationale 

behind the sub-committee choosing not to include the petitioners request for the second 

proposed listing, for use in organically labeled foods, is based on the fact that there are 

currently several alternatives available as a food additive. There are also many natural 

and organic sources available for adults to obtain Lutein through their diet.

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: [ 2] Comments: This substance has not been 

deemed to be essential by the FDA regulations for use in fortification of infant formulas.

Proposed Annotation (if any): 

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

Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: Lutein (CAS 127-40-2) as petitioned as a synthetic. 

Motion by: Harold Austin Seconded by:Jean Richardson 

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

Listing Motion: To add Lutein (CAS 127-40-2) to the National List 205.605(B) for 

use in infant formula only. Lutein using approved organic delivery ingredients.

Motion by: Harold Austin Seconded by: John Foster 

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

128
Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☒ Synthetic x Rejected3 x

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: This substance has not been deemed to be essential by 

the FDA regulations for use in fortification of infant formulas. 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

 John Foster, Subcommittee Chair July 17, 2012 

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 Does require large amounts of 

land mass to produce. Solvents 

used during process of extraction 

could pose a potential threat to 

the environment. TR lines 502-

512

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X Solvent storage tanks could be a 

potential hazard. TR lines 516-

519

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X

129
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.Are there any harmful effects on 

human health? [§6517 c (1)(A)(i); 

6517 c(2)(A)i; §6518 m.4]

X There is some speculation that it 

may play a role in Autism and 

ADHDD. No scientific support of 

these claims were found. TR 

lines 539-543

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 While the substance is not listed 

as GRAS, the petitioner has 

received several non-objection 

responses from the FDA for the 

use of Lutein, as petitioned. TR 

lines 416-433

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.

130
NOSB Evaluation Criteria for Substances Added To the National List

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

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 Solvents (hexane, isopropyl 

alcohol,etc) are used during the 

two step extraction process. TR 

lines 326-329

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 petitioner claims that it uses a 

process similar to that used in the 

manufacture of Pectin or Lecithinunbleached. TR lines 373-378 

mention this claim. The TR lines 

384-389

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X

4. Is there a natural source of the 

substance? [§205.600 b.1]

X Human breast milk. Green 

vegetables such as spinach, kale, 

broccoli, and green peas.

5. Is there an organic substitute? 

[§205.600 b.1]

X Powdered Lutein processed from 

green vegetables can be made, 

but the amount needed to equal 

the marigold source is not feasible 

in handling and food processing. 

Beta-carotene would be an 

alternate source as a coloring 

agent. Green vegetables and 

human breast milk.

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 Human breast milk. The TR (lines 

120-122) also mentions skim milk 

powder and whey protein.

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? 

X The TR (lines 120-122) indicates 

that skim milk powder and whey 

131
[§6518 m.6] protein are possible sources of 

Lutein. The TR (lines 360-371) 

discusses obtaining lutein from 

microalgae, which may be a truly 

non-synthetic source and appears 

to be feasible, although not in 

commercial production at this time.

10.Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X Breast feeding

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.

132
NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: 

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X

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 It can be used as a color additive, 

but the primary petition purpose is 

as a nutritional additive.

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

133
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: Name

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

regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic 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:

a. Regions of production 

(including factors such as 

climate and number of 

X

134
regions);

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.

135
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Lycopene

July 24 2012

Summary of Proposed Action:

Synthetic lycopene is currently used in organic infant formula. Under previous NOP 

policy regarding nutrient vitamins and minerals, an interpretation was made that 

synthetic ingredients such as lycopene were allowed without being added to the 

National List. Current NOP policy requires a specific addition to the National List. 

Lycopene is neither a vitamin nor a mineral. Lycopene is a carotenoid used as a dietary 

antioxidant and a color. Its petitioned use is not as a preservative or a color. 

In 1995, the NOSB made the following recommendation in “The Use of Nutrient 

Supplementation in Organic Foods”.

Upon implementation of the National Organic Program, the use of synthetic 

vitamins, minerals, and/or accessory nutrients in products labeled as organic 

must be limited to that which is required by regulation or recommended for 

enrichment and fortification by independent professional associations. 

The NOP did not implement accessory nutrients. Lycopene is not required by FDA or 

other regulation for infant formula. Neither the petition nor the Technical Review (TR) 

states that any independent professional association recommends it as an accessory 

nutrient at any specific level for enrichment or fortification. Neither the petition nor the 

TR presented definitive scientific information to conclude that lycopene is essential for 

addition to infant formula. The manufacturer notification to FDA of GRAS status

(generally recognized as safe) for synthetic forms of lycopene for nutrient use does not 

include use in infant formula. 

The human body does not produce Lycopene. However, depending on the amount of 

Lycopene consumed in the diet of lactating mothers, Lycopene appears in varying 

amounts in colostrum and breast milk. Lycopene is added to infant formula to make it 

more closely resemble breast milk. Levels of lycopene from natural sources in infant 

formulas are low. Natural and organic sources of lycopene are derived mainly from 

tomatoes. These sources also contain proteins from the originating plant that could be 

allergens. According to the petition, it is advisable to delay the introduction of potential 

allergens in infants less than 6 months old or even older for infants with allergy prone 

parents. There is no evidence that an allergy to tomatoes would produce allergic 

reactions to nonsynthetic lycopene, and the information in the TR hypothesized that 

allergic reactions to tomatoes are related to acidity and not specifically to lycopene.

The TR presented very little information on what alternatives are available in infant 

formula. Lycopene in breast milk is nonsynthetic. Natural and organic lycopene can be 

consumed in many foods, especially tomatoes, by lactating mothers. The TR states, 

136
“The commercial use of nonsynthetic lycopene in infant formula, rather than synthetic 

lycopene, has not been reported, and no evidence indicating that nonsynthetic lycopene 

would act as a viable substitute for synthetic lycopene in infant formula has been 

identified.” Nonorganic agricultural lycopene for use as a coloring was rejected for 

addition to the National List by the NOSB in 2007 for lack of justification for not 

producing lycopene from organic sources. There is no allowance for synthetic lycopene 

in organic infant formula or other organic foods in European, Canadian or Japanese 

organic standards. 

Synthetic crystalline lycopene, the petitioned material, involves the use of synthetic 

solvents dichloromethane and toluene in the extraction process. The TR states, 

“Synthetic lycopene may also contain residues of volatile solvents. However, no 

information has been identified to indicate that any reported residues of heavy metals or 

other contaminant in excess of FDA tolerances have been identified.” Information is 

presented on residual extracting solvents in the final product in a different form (not 

petitioned) of synthetic lycopene produced from B. trispora by the manufacturer 

Vitatene. 

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 ☐ Yes x☐ No 

☐ N/A

3. Compatibility & Consistency ☐ Yes x☐ No 

☐ N/A 

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

x 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [2 & 3 ] Comments: 

Proposed Annotation (if any): 

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

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state 

actual motion):

Classification Motion: Moved that Crystalline Lycopene be classified as a synthetic 

material. 

Motion by: Zea Sonnabend Seconded by: Tracy Favre 

Yes: 5 No: # Absent: 2 Abstain: # Recuse: #

Listing Motion: Moved that Crystalline Lycopene (CAS #502-65-8) for use in infant formula 

be added to the National List sec. 205.605(b). 

137
Motion by: Jean Richardson Seconded by: Harold Austin 

Yes: # No: 5 Absent: 2 Abstain: # Recuse: #

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling x☐ Synthetic x☐ Rejected3 x☐

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: Not essential to or consistent with organic production. 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair July 24, 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? 

Substance: Lycopene

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 No specific information found with 

regard to use of volatile synthetic 

solvents to demonstrate no adverse 

effects.

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

x No specific information found with 

regard to use of volatile synthetic 

solvents to demonstrate no adverse 

effects.

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

138
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 Self certified as GRAS but not for 

infant formula.

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.

139
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? 

Substance: Lycopene

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 Petition and 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

3. Is the substance created by naturally 

occurring biological processes? [6502 

(21)]

x

4. Is there a natural source of the 

substance? [§205.600 b.1]

x Foods high in lycopene, such as 

tomatoes.

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 Agricultural sources, such as 

tomatoes.

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 Natural agricultural lycopenes.

10. Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

x Breast feeding.

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.

140
NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: Lycopene 

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 a processing aid or adjuvant as 

referred to in 205.600(b)(2)

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;

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.

141
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: Lycopene

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

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 

x

142
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

143
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

L-Carnitine

June 19, 2012

Summary of Proposed Action:

L-Carnitine is a compound that is synthesized in the body from the amino acids lysine 

and methionine. These amino acids are abundant in foods such as beans, avocado and 

red meat. The synthetic form has been petitioned for use in infant formula because soybased formulas contain very low levels of carnitine, and infants are less able to 

synthesize carnitine for themselves. Cow's milk formulas also can be low in carnitine 

because the milk is diluted in the formula.

Unlike some other ingredients petitioned for infant formula, carnitine is not required 

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. Also it appears that carnitine would be feasible 

to make or extract from non-synthetic sources, although that is not commercially done 

at this time. For these reasons the Handling Sub-committee is not recommending to add 

synthetic L-carnitine 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 ☐ Yes X 

No ☐ N/A

3. Compatibility & Consistency ☐ Yes X 

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: [2] Comments: 

This substance is not deemed to be essential by FDA regulations for the fortification of 

infant formula.

Proposed Annotation (if any): 

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

Citation 

Notes: 

144
Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: L-Carnitine [CAS #541-15-1] as petitioned is synthetic.

Motion by: Zea Sonnebend Seconded by: Harold Austin

Yes: # 5 No: # 0 Absent: # 1 Abstain: # 0 Recuse: #0

Listing Motion: To add L-Carnitine [CAS #541-15-1] to the National List 205.605 

(b)--for use in infant formula only.

Motion by: John Foster Seconded by: Harold Austin

Yes: # 2 No: # 3 Absent: # 1 Abstain: # 0 Recuse: #0

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling x Synthetic x Rejected3 x

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: It appears that carnitine would be feasible to make or extract 

from non-synthetic sources, although that is not commercially done at this time.

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair June 19, 2012

NOSB Evaluation Criteria for Substances Added To the National List

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

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

2. Is there environmental 

contamination during manufacture, 

X

145
use, misuse, or disposal? [§6518 

m.3]

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.Are there any harmful effects 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 may be self identified. See TR 

Evaluation question #4 (lines 350 

- 363)

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.

146
NOSB Evaluation Criteria for Substances Added To the National List

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

L-Carnitine

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 while there are non-synthetic ways 

to manufacture it, most in use for 

supplementation is synthesized 

from epichlorhydrine or 

trimethlamine. (TR lines 285-287)

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

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X X it can be produced by "biosynthetic 

or fermentative methods" (TR lines 

294-295) but it is not clear if these 

would be considered nonsynthetic. It appears from the TR 

discussion for Evaluation questions 

#1 and #2, that non-synthetic 

production would be possible but is 

not commercially done in the US at 

this time.

4. Is there a natural source of the 

substance? [§205.600 b.1]

X abundant in food and human 

breast milk.

5. Is there an organic substitute? 

[§205.600 b.1]

X organic food

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 human breast milk

8. Is the substance used in handling, 

not synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

X

9. Is there any alternative X human breast milk

147
substances? 

[§6518 m.6]

10.Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X breast feeding

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.

148
NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: L-Carnitine 

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X since the substance could be 

obtained from organic foods, the 

synthetic fortification is not 

compatible with organic handling.

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; 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, 

X

149
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.

150
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: Name

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

regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic form of the material 

/substance is necessary for use in 

organic handling? 

X provided but not convincing.

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 

X

151
climate and number of 

regions);

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.

152
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

L-Methionine

July 3, 2012

Summary of Proposed Action:

The Team Leader for Infant Formula Regulation at FDA provided information about the 

need for L-Methionine in soy based formulas in order to meet requirements for protein 

quality at 21 CFR 107.100 (f) . Subcommittee members have reservations about 

approving synthetic L Methionine, because toxic solvents are used in extraction 

process. However the subcommittee recommends approval, acknowledging the fact 

that if L-Methionine is not added to soy formula there would be no organic soy based 

formula. The group discussed the fact that protein is the essential building block and 

there does not seem to be an alternate source of non-milk protein available in 

commerce for use for infant formula. 

Additional comments: The Handling Subcommittee would welcome public comment 

about alternatives. 

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria 

Satisfied? (see “B” below)

1. Impact on Humans and Environment ☐ Yes X 

No ☐ N/A 

2. Essential & Availability Criteria X Yes ☐

No ☐ N/A

3. Compatibility & Consistency ☐ Yes ☐

No X 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): 

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

Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

153
Classification Motion: Motion to list L-Methionine on 205.605(b) as synthetic, nonagricultural.

Motion by: TF Seconded by: HA

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

Listing Motion: Motion to list L Methionine for inclusion on 205.605(b). For use only 

in infant formula made with isolated soy-based protein.

Motion by: TF Seconded by: HA

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

Crops ☐ Agricultural ☐ Allowed1 X

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling X Synthetic X Rejected3 ☐

2No 

restriction

☐ Commercial unavailable as 

organic

X Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205.605(b) with 

Annotation (if any): For use in or on processed infant formula labeled as “organic” 

or “made with organic ingredients”. Annotated: For use only in formula made with 

isolated soy-based protein.

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

John Foster, Committee Chair July 3, 2012

154
NOSB Evaluation Criteria for Substances Added To the National List

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

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 X Yes, manufacture of synthetic LMethionine typically is obtained 

from a precursor DL-Methionine, 

which uses Cyanide, considered 

an extremely toxic and volatile 

chemical. Inadvertent release of 

Cyanide has happened and has 

caused environmental damage.

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X X 

Yes, see above comment.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X 

Continued use of synthetically 

manufactured L-Methionine has 

the potential to delay the 

development of naturally 

obtained sources, including 

aquatic sources

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 Over supplementation of LMethionine has shown to have 

detrimental effect on the uptake 

of other critical amino acids

6. Are there adverse biological and 

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

X L-Methionine breaks down fairly 

quickly in the environment and is 

therefore not considered a risk to 

soil or water health.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X See above comments

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 

X

155
environment? [§6518 m.2]

10.Is there any harmful effect on 

human health? [§6517 c (1)(A)(i); 

6517 c(2)(A)i; §6518 m.4]

X X Over supplementation of LMethionine is hepatoxic, causing 

fatty deposits in the liver. Normal 

supplementation has not shown 

detrimental effects, and is, in fact, 

an essential amino acid.

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.

156
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? 

Substance: L-Methionine

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 X Both synthetic and non-synthetic 

methods exist, but only the 

synthetic method is commercially 

available.

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 X The manufacture of L-Methionine 

can be accomplished from natural 

materials, however, only the 

completely synthetic methods are 

commercially viable.

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X L-Methionine is an essential amino 

acid that is obtained in the human 

diet from meat, dairy and some 

grains. The human body is not 

able to synthesize it.

4. Is there a natural source of the 

substance? [§205.600 b.1]

X See above

5. Is there an organic substitute? 

[§205.600 b.1]

X Yes, but not commercially viable at 

this time.

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 It may be obtained from natural, 

whole food sources.

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 Cow’s milk, meat and some grains 

are sources, but for soy-based 

formulas, L-methionine is not 

available in sufficient amounts to 

meet the dietary requirements of 

infants.

10.Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X Breastfeeding would eliminate the 

need for soy-based formulas

157
NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: L-Methionine

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X Previous TAP and TR indicate 

that the synthetic manufacture of 

L-methionine is not considered 

compatible with organic handling

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

X X Petitioned use is for soy-based 

infant formula only, but is not 

consistent with organic farming.

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 In fact, this is the only justification 

for inclusion of L-methionine in 

soy-based formulas

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 It is required in order to bring 

nutrient contents of soy-based 

formula up to milk-based formulas 

and mother’s milk.

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories:

copper and sulfur compounds;

X This is a sulfur-based amino acid.

a. toxins derived from bacteria; X

b. pheromones, soaps, 

horticultural oils, fish 

emulsions, treated seed, 

vitamins and minerals?

X

c. livestock parasiticides and 

medicines?

X

d. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, 

row covers, and equipment 

cleaners?

X

158
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: Name L-Methionine

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

regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic 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 Quality of the substance has not 

been discussed, rather the 

commercial availability of the 

organic version

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

159
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 X Not provided but not relevant to 

manufacture.

d. Trade-related issues such as 

evidence of hoarding, war, 

trade barriers, or civil unrest 

that may temporarily restrict 

supplies; or

X X Same as above

e. Are there other issues which 

may present a challenge to a 

consistent supply?

X Only as related to organic and 

non-synthetic versions of LMethionine

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.

160
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 

161
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 

162
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.

163
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. 

 

164
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. 

165
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 

 

166
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.

167
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Taurine

July 3, 2012

Summary of Proposed Action:

Taurine is a compound that is synthesized in the body from methionine and cysteine metabolism. While 

not technically an amino acid it is more accurately classified as a B-amino sulfone. It is found in animal 

protein such as seafood, beef and chicken and nearly absent from vegetarian foods. The synthetic form 

has been petitioned for use in infant formula because insufficient taurine could result in subpar fat 

digestion and absorption in infants.

Taurine is not required under the FDA in 21 CFR 104.20(d)(3), 107.100 or 107.10. Taurine can be made 

or extracted from non-synthetic sources, although apparently available only in small amounts at this time. 

Although essential for cats and thus added to cat pet food, taurine is considered a non-essential human 

dietary supplement.

The Handling Sub-committee is not recommending addition of Taurine 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 ☐ Yes X No ☐

N/A

3. Compatibility & Consistency ☐ Yes X 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: [ 2] Comments: 

This substance is not deemed essential by FDA regulations for fortification of infant formula

Proposed Annotation (if any): 

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

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state 

actual motion):

Classification Motion: Taurine (CAS# 107-35-7) as petitioned is synthetic.

Motion by: Jean Richardson Seconded by: Joe Dickson

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

Listing Motion: To add Taurine (CAS 107-35-7) to the National List 205.605 b for use in 

infant formula only.

168
Motion by: Seconded by: 

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

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling X Synthetic X Rejected3 X

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: 4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair July 3, 2012

NOSB Evaluation Criteria for Substances Added To the National List

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

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 Inasmuch as the TR addressed this 

issue there does not appear to be 

adverse environmental effects

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?

X

169
[§6518 m.2]

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 None cited in TR

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 X TR Line 290 “taurine is not listed as 

GRAS..”

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.

170
NOSB Evaluation Criteria for Substances Added To the National List

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

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 There are non-synthetic ways to 

manufacture taurine (TR lines 264-

268) much of the taurine used is 

created by commercial chemical 

processes (TR lines 262-263) 

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

3. Is the substance created by naturally 

occurring biological processes? [6502 

(21)]

X X Taurine is extracted from natural 

sources (TR 264-268) but only in 

small quantities

4. Is there a natural source of the 

substance? [§205.600 b.1]

X Abundant in animal protein in food 

sources, and in human breast milk.

5. Is there an organic substitute? [§205.600 

b.1]

X Organic food

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 Human breast milk

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 Human breast milk

10. Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

X Breast feeding

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.

171
NOSB Evaluation Criteria for Substances Added To the National List

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

Taurine

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X Because the substance could be 

obtained from organic foods the 

synthetic dietary supplement 

fortification is not compatible with 

organic handling

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 Taurine is a non-essential dietary 

supplement (TR), lack of which “could 

result in subpar fat digestion and 

absorption by infants” (Petition, page 

4, paragraph 4)

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; 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.

172
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: Taurine

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 Provided, but not detailed.

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

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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.

174
National Organic Standards Board

Handling Subcommittee

"Other Ingredients" Discussion Document

August 21, 2012

Introduction1

On Nov. 23, 2011, National Organic Program (NOP) Deputy Administrator Miles McEvoy 

sent a Memorandum to the National Organic Standards Board (NOSB) requesting 

clarification of “other ingredients” contained within handling materials on the National List of 

Allowed and Prohibited substance used in processed organic products. Since OFPA 

requires that each non-organic ingredient be specifically allowed, and because the National 

List does not specifically list “other ingredients” commonly found in formulated products, the 

NOP identified the need for clarity and requested that the NOSB develop a policy that 

specifies whether these “other ingredients” are allowed.

In the memo to NOSB, NOP requested the following:

The NOP is requesting that the NOSB develop a policy on “other ingredients” in § 

205.605 substances that is comparable to the comprehensive policy for crop and 

livestock materials. From this point forward, NOP is requesting that NOSB consider the 

presence of any “other ingredients” as part of its processes. As substances on the 

National List come up for sunset review, or as new petitions are considered, NOP 

requests that NOSB clarify whether any restrictions are warranted for “other ingredients” 

in § 205.605 substances. Any third-party technical report that NOP provides will include 

information on any “other ingredients” commonly found in the substance under review.

NOP is requesting that NOSB specify any allowed “other ingredients” in the background 

section of its recommendations for substances recommended for listing on § 205.605, 

so that these allowances are clear to the organic trade, certifying agents, and NOP. Any 

“other ingredients” not listed on § 205.605 or not referenced in the background section 

of the recommendation, would not be allowed in formulations of substances on § 

205.605 that are used in or on processed products labeled as “organic” or “made with 

organic (specified ingredients or food group(s)).”

The memo continues:

NOSB may want to address the subject further in the future with a comprehensive policy 

for “other ingredients” that may be included in permitted handling materials. Some 

questions that could be addressed in a future recommendation could include the 

following:

1. Should all agricultural ingredients that are “other ingredients” be organically 

produced?

2. Are synthetic preservatives allowed as “other ingredients?

In response to the memo, the NOSB Handling Sub-Committee is currently working to 

develop a policy for “other ingredients” that may be included in permitted handling materials. 

This discussion document defines “other ingredients” and the scope of their review, 

1

 The NOSB Handling Subcommittee wishes to thank the members of the ad hoc Materials Working Group for providing a framework 

for this Discussion Document. Their names are in Appendix 3.

175
provides historical and regulatory background, and proposes a range of policy options for 

consideration along with an assessment of their impact on the organic sector.

Background 

The NOP regulations require that all certified organic producers and handlers use materials 

that comply with the applicable parts of the Standards [7 CFR Part 205]. The Standards 

include Subpart G (The National List), which dictates allowed synthetic and prohibited 

nonsynthetic inputs for use in organic crop and livestock production and nonorganic 

substances allowed in organic food processing and handling. 

In general, for crop and livestock production, non-synthetic materials are allowed unless 

prohibited. Synthetic substances may be used provided they are on the National List and 

used in accordance with any specified restrictions. In contrast, the handling standards 

require that all non-organic non-agricultural substances, whether synthetic or non-synthetic, 

be included on the National List. Non-organic agricultural ingredients used in the 5% of an 

“organic” product must also be on the National List AND commercially unavailable in 

organic form.

Some items on § 205.605 and on § 205.606, however, are sold as multicomponent 

substances or mixtures wherein the “active” or listed substance is combined with “other 

ingredients,” (e.g. carriers, stabilizers and antioxidants) to provide a necessary technical 

effect on the National List substance. In certain cases, small amounts of standardizing 

agents may be incorporated to ensure the substance meets the specifications required by 

their standards of identity. Examples of § 205.605 substances that generally contain “other 

ingredients” include, but are not limited to, biological substances such as enzymes, dairy 

cultures and microorganisms; cleaners, sanitizers and disinfectants such as peracetic acid; 

and nutrient vitamins. Examples of § 205.606 items that generally contain “other 

ingredients” include, but are not limited to, casings from processed intestines, colors, fish 

oil, pectin, and whey protein concentrate.

The chart in Appendix 4 lists the substances currently on §205.605, the specific list of nonagricultural substances that are the subject of the NOP request; the agricultural substances 

currently listed at §205.606, which were not mentioned in the NOP request but some of 

which share the characteristic of containing “other ingredients”; and those substances 

recommended by NOSB but which have not yet completed the process, along with those 

“other ingredients” identified in the original petition, a Technical Advisory Panel (TAP)

review or a Technical Report (T)R). The chart also references examples of “other 

ingredients” that are disclosed on specification sheets that certifiers use when determining 

compliance for a formulated ingredient.

Currently, the allowance of “other ingredients” in substances on the National List used in 

processed organic products is unclear, particularly in contrast with crop and livestock 

substances. For organic crop and livestock production, specific categories of “other 

ingredients” are allowed as inert ingredients in pesticides and excipients in animal drugs. 

While inert ingredients used in pesticide products, and excipients used in animal drugs are 

addressed, the regulations are silent on “other ingredients” used in non-pesticide and nondrug products. As stated in the NOP memo of November 23, 2011, for crop and livestock 

176
products, a synthetic “other ingredient” is prohibited unless it appears on the National List 

and non-synthetic “other ingredients” are allowed unless prohibited by the National List. 

The Handling Subcommittee believes that exceptions have been made for livestock 

vitamins and minerals due to the fact that they commonly contain “other ingredients” but 

their use is required to fulfill the nutritional needs of certified livestock.

In contrast, the National List for processed products does not include a provision that 

provides allowances for any “other ingredients”. Instead, certain substances on the National 

List, such as flavors, colors and fish oil, specify a restriction on the use of “other 

ingredients.” This has led some to believe that “other ingredients” used in handling 

materials are allowed unless specifically prohibited. 

Relevant areas in OFPA and Regulations (see Appendix 1 for full references)

OFPA prohibits a certified handler from adding “any synthetic ingredient not appearing on 

the National List during processing or any postharvest handling.” The National List heading 

in the regulations at § 205.605 and § 205.606 also specify the use of non-agricultural 

substances and agricultural products, respectively, referred to as ‘ingredients.’ While 

OFPA does not reference processing aids, the regulations under § 205.301(f)(4) prohibit 

the use of ‘processing aids’ during the handling of an organic product unless they are 

approved on the National List. Both terms are included under 205.2 (Terms Defined). 

Furthermore, in the final ruling on the Harvey II case the Courts determined that Congress 

did not distinguish between the general term “ingredients” and “processing aids,” and 

authorized the use of synthetic substances, whether ingredients or processing aids, for the 

use in handling operations so long as they appear on the National List.

2

. 

The Federal Rule § 205.301 determines that product composition for products labeled as 

"organic" must contain only ingredients that are organically produced (95%) or "be 

nonagricultural substances or nonorganically produced agricultural products produced 

consistent with the National List in subpart G of this part".

Examples of specified restrictions addressing "other ingredients" in § 205.605 include:

Flavors, nonsynthetic sources only and must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.

Peracetic acid/Peroxyacetic acid (CAS # 79–21–0)—for use in wash and/or rinse 

water according to FDA limitations. For use as a sanitizer on food contact surfaces.

Examples of specified restrictions addressing "other ingredients" in § 205.606 include:

(d) Colors derived from agricultural products—Must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.

2

OFPA does not refer to ‘processing aids.’ However, in the final ruling on the Harvey II case Nov. 2, 2006, the District Court of 

Maine ruled that the OFPA change of 2005 that allowed synthetic “ingredients” also allowed synthetic “processing aids” as long as 

they appear on the National List. The Court determined that Congress did not distinguish between the general term “ingredients” and 

“processing aids,” and authorized the use of synthetic substances, whether ingredients or processing aids, for the use in handling 

operations so long as they appear on the National List (Memorandum Decision on Motion to Enforce Judgment and Cross Motion for 

Relief from Judgment, U.S. District Court, District of Maine, Civil Docket 2:02cv216).

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(f) Fish oil (Fatty acid CAS #'s: 10417–94–4, and 25167–62–8)—stabilized with 

organic ingredients or only with ingredients on the National List, §§205.605 and 

205.606.

The inconsistent use of the term ‘substance’ used throughout OFPA and the regulations, 

and the Federal Register Notice on Procedures for Submitting National List Petitions [72 

Federal Register 2167] has not fostered a clear and consistent approach to the issue. The 

Notice reads:

Any person may submit a petition requesting a substance to be reviewed by the NOP 

and NOSB at any time. Each substance to be evaluated for the National List must be 

submitted in a separate petition. Only single substances may be petitioned 

for evaluation; formulated products cannot appear on the National List.

Discussion

Defining “other ingredients”

This discussion paper focuses on the use and allowance of “other ingredients” contained 

in § 205.605 items. The term “other ingredients,” as described in the NOP Memo to NOSB, 

is not a recognized regulatory term with a legal definition. However since the term was 

used in the NOP Memo, it will be used throughout this discussion document. For this

purpose, “other ingredients” will be defined as additives added during the manufacturing of 

a non-organic substance and not removed. They are defined as “incidental additives” by 

FDA.

FDA defines “incidental additives” as ingredients that are present in a food at insignificant 

levels and do not have any technical or functional effect in that food. An incidental additive 

is usually present because it is an ingredient within another ingredient used in the final 

product, or it is a processing aid added to a food for its technical or functional effect in the 

processing and present only in insignificant amounts in the final food. In such cases, per 

FDA labeling regulations, incidental additives and processing aids do not need to be 

declared on the label of the final food (certified product) (CFR Title 21 101.22(h)(3) and 

101.100 (a)(3i to iii4). See Appendix 2 for other relevant FDA Definitions.

It should be clear that “other ingredients” discussed in this paper are not the same as 

“ingredients” or “processing aids” used for a specific purpose directly by a certified handler 

in or on processed organic products. The regulations are clear that non-organic 

‘ingredients’ or ‘processing aids’ used directly by a certified handler in or on a certified 

organic processed product must be on the National List at § 205.605 or § 205.606. “Other 

ingredients” are substances that are present by way of having been incorporated into an 

allowed substance on the National List. As such, most, if not all “other ingredients,” will fall 

under FDA’s definitions for incidental additives and, if present at only insignificant levels, 

are exempt from FDA’s labeling requirements. 

The NOP memo only requested a policy on § 205.605 listings on the National List. 

However non-organic agricultural ingredients or products listed on § 205.606 of the 

National List often contain "other ingredients" also. The Handling Sub-Committee believes 

it will be more efficient and result in overall better comprehension to address both sections 

178
of the National List at the same time. Therefore, we have incorporated § 205.606 into our 

policy options in this discussion paper.

We have not presented policy options for synthetic solvents and processing aids used 

during the production of non-organic ingredients on § 205.605 and § 205.606 in this 

document. This topic is part of the overall ‘Classification of Materials’ discussion, thus we 

believe it is outside the scope of the “other ingredients” discussion provided the processing 

aids or solvents undergo a removal step. 

Baseline Criteria 

We believe that baseline criteria that should be used for the evaluation of “other 

ingredients,” based on the existing requirements that are already imposed by OFPA and 7 

CFR Part 205. This would parallel those identified in the NOP Memo for Inerts in crop 

pesticides and Excipients in Livestock drugs. These baseline criteria would apply to all 

policy options for review of ingredients.

The baseline criteria are as follows:

“Other ingredients” are those that are authorized for use in materials on the National List at 

§ 205.605 and § 205.606 according to the following criteria:

1. The National List [7 CFR 205.605 – 606] or;

2. Mandatory federal requirements [7 U.S.C. §6519(f)] or;

3. FDA (GRAS) or otherwise [7 U.S.C. § 6517(c) and 7 U.S.C 6519(f)]; or

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)].

AND any component or ingredient would be disallowed if:

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

7. Produced using excluded methods [7 CFR 205.105(e) and 7 CFR 205.2] or;

8. Contain any heavy metals or toxic residues in excess of established tolerance levels 

set by FDA or EPA [7 U.S.C. § 6510(a)] or;

9. It provides a technical or functional effect in the final certified organic product and 

therefore does not meet FDA’s definition of an ‘incidental additive’.

Policy Options

NOSB currently evaluates materials on a case-by-case basis without an overarching policy 

for “other ingredients.” Additionally, ACAs and MROs have no overall guidance on other 

ingredients from the NOP, varying capacities for materials review and wide latitude to make 

decisions unless specific decisions are overruled by the NOP. While the review of materials 

in general for use in organic production and handling is currently quite rigorous, there is 

need for improvement and harmonization of the system to assure continued confidence 

and growth of the industry. 

NOP clearly recognizes the need to improve review of non-organic ingredients as reflected 

by their declaration in the memo that third party technical reports will include information on 

“other ingredients” and their request that NOSB consider their presence as part of their 

review process “from this point forward.” In acknowledgement of this request, the options 

179
presented all include NOSB review of “other ingredients”. A fundamental variation between 

the options however is the method by which NOSB specifies the allowance of “other 

ingredients” after they have conducted their review. 

Option A simply includes NOSB review of “other ingredients” as requested by NOP, but 

allows for the presence of all “other ingredients” unless they are restricted or prohibited by 

an annotation. Option B aligns with the request in the NOP memo, but includes suggestions 

to help facilitate review by certifiers and MROs and includes additional criteria that are 

specific to the various categories of materials on § 205.605 and § 205.606. Option C 

presents a blanket policy that while easy to understand would be very challenging to 

implement. The pros and cons of each option are described in further detail below.

Option A 

For all newly petitioned non-organic ingredients, the NOSB considers "other ingredients" 

identified in the petition and Technical Report and documents the review in the background 

section of their recommendation. Items already on the National List are not subject to this 

provision, unless the NOSB explicitly requests a Technical Report to address the ‘other 

ingredient’ question of a particular item subject to Sunset Review. Unless restrictions are 

specified in an annotation, any “other ingredient” that meets Baseline Criteria is permitted.

Review Criteria for NOSB

Other ingredients must meet Baseline Criteria (above). NOSB will determine whether 

any specific prohibitions that should be specified in an annotation based on their review 

of “other ingredients” discussed or disclosed in the petition or Technical Report or 

presented in further research or public comment. 

Pros:

• Processors, handlers and their suppliers have the greatest possible latitude to 

formulate ingredients and develop organic products.

• ACAs and MROs have a minimum amount of documentation to review.

• All products that meet the current standard and policy comply unless NOP specifies 

otherwise.

• Policy is the least likely to cause inconsistencies with major trading partners. 

• Greater number of options for non-organic ingredients.

• Less time and energy spent on the allowed non-organic portion freeing up more time 

to advocate and work towards increased organic production.

Cons:

• Little incentive to source organic alternatives to ingredients on 7 CFR 205.605.

• There is no transparent way to be able to look up all of the non-organic substances 

that might be contained in a certified product containing non-organic ingredients.

• Potential decline in the value of the organic label due to dilution and loss of 

consumer confidence.

Option B 

The NOSB would follow the request by NOP to consider “other ingredients” during their 

review as substances come up for sunset review or as new petitions are considered. The 

NOSB would review “other ingredients” included in the petition and Technical Report. The 

180
NOSB recommendation includes a note that the other ingredients were reviewed and 

accepted. The “other ingredient” is entered into a database maintained on the NOP 

Website. Materials listed on § 205.605(a) and § 205.606 must not contain any "synthetic" 

incidental additives unless they are on the National List at § 205.605(b) or specifically 

allowed by NOSB. Non-synthetic incidental additives are allowed unless specifically 

prohibited. Synthetic incidental additives are allowed in 205.605(b) items if they are 

included and documented in the NOSB review. Any additional restrictions are specified in 

an annotation. 

Other ingredients in general product categories that are currently on § 205.605 and § 

205.606 and currently used in certified organic processed product will be grandfathered for 

one sunset period recommendations, including vitamins, minerals, enzymes, dairy cultures, 

yeast, microorganisms, natural flavors, and colors. NOSB can recommend exceptions for 

new materials that are petitioned as appropriate. The National List is restructured to create 

a separate category and exceptions for cleaners, sanitizers, disinfectants and other 

substances that are secondary direct and indirect food additives subject to a separate 

Baseline Criteria.

Review Criteria for NOSB:

• Other ingredients must meet Baseline Criteria (above). 

• NOSB considers “other ingredients” as disclosed in the petition and Technical 

Report.

• If the substance is recommended for inclusion on the National List, the NOSB 

may specify implicit allowance of all other ingredients, deny allowance of other 

ingredients, or prohibit those other ingredients in the recommendation. 

• NOSB may recommend “other ingredients” individually, categorically or a 

combination of both. 

• Non-synthetic ingredients used as other ingredients in items are allowed unless 

specifically prohibited. 

• The NOSB may stipulate in a review that any agricultural "other ingredients" must 

be organically produced.

• Materials listed on § 205.605(a) and 205.606 must not contain any "synthetic"

incidental additives unless they are on the National List at § 205.605(b) or 

specifically allowed by NOSB.

• Synthetic incidental additives are allowed in 205.605(b) substances if they were 

reviewed, approved and documented by NOSB.

• NOSB specifies any additional restrictions or allowances in an annotation. 

• As a part of the Sunset Review process, the NOSB should request Technical 

Reports on the following product categories currently on the National List: 

o Vitamins/Minerals

o Enzymes (including animal enzymes)

o Microorganisms

o Dairy Cultures 

o Natural Flavors

o Agricultural Colors

The TR will help the NOSB determine whether other ingredients that are not 

“organic” or on the National List are currently being used in these categories and 

whether to recommend annotation or documentation in the database.

181
• “Other ingredients” contained in sanitizers or cleaners or other similar non-food 

inputs that are used in direct contact with certified product must be on the 

National List or their allowance must be specified through an annotation via a 

CAS number or reference to another agency’s regulation, (e.g. peracetic acid), or 

their use must be mandated by law or specifically allowed through NOP Policy.

• Substances classed by FDA as secondary direct or indirect additives not used in 

direct contact with certified product are allowed provided the operator has clear 

intervention/contamination prevention measures detailed in their OSP.

Pros: 

• Greater consistency amongst ACA’s and MRO’s.

• Having the NOSB provide relevant annotations for each material would enable each 

material to be looked at in its context. 

• The NOSB assessment would be open for review and public comment, bringing 

greater transparency. 

• Would clarify the review process for most materials that contain carriers, stabilizers, 

standardizing agents.

• Most likely to meet many if not most consumer advocates expectations for organic 

food.

• Individual ingredients would be assessed according to use and type.

• Other regulatory agencies would be referred to for legally approved formulas for 

cleaners, sanitizers, boiler additives. 

Cons:

• Annotations can still be interpreted differently and may not always be clear. 

• Annotations are verified through desk audit. Increased paperwork for verification 

purposes.

• This option could only work if there is a consistent policy/decision tree on how to 

determine nonsynthetic vs. synthetic.

• More work for the NOSB.

• More work for ACAs and MROs to collect and review the necessary information.

• Only certain specific formulas will be petitioned and receive Technical Reports.

Some Branded formulations currently used in organic processed products may 

include other ingredients not reviewed because the manufacturer is unable or 

unwilling to disclose all of the ingredients. 

• The NOP may not keep up the aforementioned database

Option C

All ingredients in a processed product labeled as organic must either be organically 

produced or on the National List. NOSB creates three new sections to the National List that 

are designated for incidental additives only (other ingredients). They may not be used 

directly by a certified handler in or on a certified product. They are allowed only by way of 

having been incorporated into a substance appearing on § 205.605 or § 205.606 of the 

National List. 

Review Criteria for NOSB

182
• Review all petitions for other ingredients according to the Baseline Criteria, the 

regulations and guidance. 

• Review during Sunset the “other ingredients” not previously petitioned or allowed.

• Suspend all new petitions for final ingredients until there are petitions for other 

ingredients. (Or: Require petitioners of final ingredients to submit petitions for other 

ingredients if not previously petitioned or allowed.) 

• NOSB creates three new sections to the National List that are designated for 

incidental additives only (other ingredients). The new sections would be as follows:

o § 205.607(a) Non-synthetic nonagricultural incidental additives allowed only in 

substances that appear on § 205.605(a) or § 205.605(b); 

o § 205.607(b) Synthetic nonagricultural incidental additives allowed only in 

substances that appear on § 205.605(b); and

o § 205.607 (c) Non-organic agricultural incidental additives allowed only in 

substances that appear on § 205.605(a), § 205.605(b), or § 205.606.

• Exceptions are made for cleaners, sanitizers, disinfectants and secondary direct 

food additives:

o “Other ingredients” contained in sanitizers or cleaners or other similar nonfood inputs that are used in direct contact with certified product must be on 

the National List or their allowance must be specified through an annotation 

via a CAS number or reference to another agency’s regulation, (e.g. peracetic 

acid), or their use must be mandated by law or specifically allowed through 

NOP Policy.

o Secondary direct or Indirect additives not used in direct contact with certified 

product are allowed provided the operator has clear 

intervention/contamination prevention measures detailed in their OSP.

• NOSB recommends a transition time for currently listed substances that will allow 

manufactures and non-organic ingredients and certified handlers adequate time to 

bring products into compliance. NOP will specify this transition or implementation 

time in their draft and final guidance.

Pros:

• More clarity about the regulation.

• Reduced number of options for non-organic ingredients and corresponding growth of 

organic minor ingredients that would lead to increased organic acreage and 

increased business opportunity. 

• Customers who buy and eat organic foods can be certain that all the incidental 

ingredients, which by law are not required to be listed on the finished product label, 

in an organic product are either organic or on the National List.

• ACAs and MROs have a clear rule to make materials decisions. 

• Promotes a strong incentive to use organic ingredients.

• Clear and simple process for retailers and marketers to explain to consumers. 

• Most likely to meet many if not most consumer advocates expectations for organic 

food.

Cons:

183
• Most restrictive in terms of what ingredients can be used.

• All “other ingredients” (carriers, standardizing agents, stabilizers, pH adjusters, 

diluents, etc.) that are not on the National List or “organic” will need to be petitioned 

which could result in significant review and rulemaking. 

• NOP and NOSB have limited time and resources and could be overly burdened by 

the time needed to review petitions and complete necessary rulemaking. 

• Could potentially increase the number of synthetic substances on the National List, 

which may be misunderstood by consumers.

• Reduced number of options for non-organic ingredients and corresponding loss of 

products currently on the market due to limited options, especially for materials like 

pectin and gums.

• Would have commercial and cost implications for certified manufacturers that could 

lead to loss of organic products, which would lead to reduced organic acreage.

• Many products currently on the market may be non-compliant.

• Product from countries with an equivalency agreement won’t need to comply.

• Product from countries without an equivalency agreement may file a Technical 

Barrier to Trade complaint with the World Trade Organization.

• Would have commercial and cost implications for certified manufacturers

• Similar “cons” related to varying interpretations of annotations and the potential for 

the NOSB to list “other ingredients” that are petitioned by a select few. 

• May result in certified organic products currently on the market becoming 

unavailable because a manufacturer of an ingredient chooses not to reformulate to 

meet these new requirements.

Other Considerations

In the course of developing policy options for this paper, several other considerations 

became apparent. The Handling Sub-Committee hopes to do further work on some of 

these subjects in the future and brings them up here because they are relevant to reviewing 

handling materials under any of these policy options.

• It would be helpful if the NOP creates a publicly available database that documents 

material review and specifies “other ingredients” that were reviewed and approved. 

• If a new policy is adopted there will be need for transition time for operators to bring 

products into compliance. NOP will need to specify this transition or implementation 

time in their draft and final guidance. 

• We would like to explore a recommendation to move cleaners, sanitizers, disinfectants 

and other non-food substances such as boiler additives to their own designated section 

of the National List and develop policy specific to these types of items. 

• We would like to ask NOP to report on what legal and regulatory hurdles exist that 

prevent assigning commercial availability to all § 205.605. If no hurdles exist, we will 

consider drafting a recommendation that would assign commercial availability to all § 

205.605 listed substances.

Increasing the use of organic ingredients and processing aids has been a very explicit goal 

of the organic community since early on. The key to increasing organic ingredients lies in 

the interpretation of the phrase, commercial availability. The NOSB has already endorsed 

the concept of a pro-active approach to the development and creation of organic analogs to 

184
replace non-organic and synthetic items. Implementation of the pro-active program that 

would apply to both § 205.605 and § 205.606 substances would help encourage and 

further the development of organic minor ingredients. In turn this would likely stimulate the 

use of “other ingredients” in 205.605 substances that are either organic or on the National 

List.

Comments Requested

1. Which is your preferred option? Please answer with the following in mind:

a. Which option best captures the intent of the law?

b. Which option best captures the expectation of the consumer?

c. Which option is best for the growth of the organic industry?

d. Which option will be the most difficult to implement? Describe the obstacles.

2. Do you think that in general, nonsynthetic incidental additives should be allowed 

without further petitioning, review or rulemaking if they meet baseline criteria?

3. Should the use of organic substitutes be required of § 205.605 substances when 

they are commercially available?

4. Should organic preference (synthetic allowed when nonsynthetic is not available; 

nonsynthetic allowed when organic is not available) be assigned to “other 

ingredients”? Is this practical? How would it be enforced?

5. Is it acceptable to allow “other ingredients” as incidental components of an allowed 

substance on the National List? Does it make a difference knowing they are present 

at amounts typically below 10ppm?

6. Should sanitizers, cleaners and disinfectants be moved to their own section of the 

National List and dealt with separately from ingredients and processing aids? 

7. Should “other ingredients” used in sanitizers, cleaners, or disinfectants be organic or 

on the National List?

8. How can the system of reviewing non-organic ingredients used in processed organic 

products be improved? 

Sub-Committee Vote

Motion: The Handling Sub-Committee moves to accept this document and present it for full 

board discussion at the Fall 2012 NOSB meeting

Motion by: Zea Sonnabend Second: Tracy Favre

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

Appendix 1 – Regulatory References

185
OFPA

SEC. 2111. [7 U.S.C. 6510] HANDLING.

(a) IN GENERAL.—For a handling operation to be certified under this title, each person 

on such handling operation shall not, with respect to any agricultural product 

covered by this title— 

(1) add any synthetic ingredient not appearing on the National List during the 

processing or any postharvest handling

SEC. 2118. [7 U.S.C. 6517] NATIONAL LIST.

(a) IN GENERAL.—The Secretary shall establish a National List of approved and 

prohibited substances that shall be included in the standards for organic production 

and handling established under this title in order for such products to be sold or 

labeled as organically produced under this title.

(b) CONTENT OF LIST.—The list established under subsection (a) shall contain an 

itemization, by specific use or application, of each synthetic substance permitted 

under subsection (c)(1) or each natural substance prohibited under subsection (c)(2).

NOP Regulations

§ 205.2. Terms Defined.

Ingredient. Any substance used in the preparation of an agricultural product that is still 

present in the final commercial product as consumed.

Processing aid. 

(1) Substance that is added to a food during the processing of such food but is removed 

in some manner from the food before it is packaged in its finished form;

(2) a substance that is added to a food during processing, is converted into constituents 

normally present in the food, and does not significantly increase the amount of the 

constituents naturally found in the food; and

(3) a substance that is added to a food for its technical or functional effect in the 

processing but is present in the finished food at insignificant levels and does not have 

any technical or functional effect in that food.

§ 205.301 Product composition.

(b) Products sold, labeled, or represented as “organic.” A raw or processed agricultural 

product sold, labeled, or represented as “organic” must contain (by weight or fluid 

volume, excluding water and salt) not less than 95 percent organically produced raw or 

processed agricultural products. Any remaining product ingredients must be organically 

produced, unless not commercially available in organic form, or must be nonagricultural 

substances or nonorganically produced agricultural products produced consistent with 

the National List in subpart G of this part. If labeled as organically produced, such 

product must be labeled pursuant to §205.303.

(c) Products sold, labeled, or represented as “made with organic (specified ingredients 

or food group(s)).” Multi-ingredient agricultural product sold, labeled, or represented as 

“made with organic (specified ingredients or food group(s))” must contain (by weight or 

186
fluid volume, excluding water and salt) at least 70 percent organically produced 

ingredients which are produced and handled pursuant to requirements in subpart C of 

this part. No ingredients may be produced using prohibited practices specified in 

paragraphs (f)(1), (2), and (3) of §205.301. Nonorganic ingredients may be produced 

without regard to paragraphs (f)(4), (5), (6), and (7) of §205.301. If labeled as containing 

organically produced ingredients or food groups, such product must be labeled pursuant 

to §205.304.

(f) All products labeled as “100 percent organic” or “organic” and all ingredients 

identified as “organic” in the ingredient statement of any product must not:

(4) Be processed using processing aids not approved on the National List of Allowed 

and Prohibited Substances in subpart G of this part: Except, That, products labeled 

as “100 percent organic,” if processed, must be processed using organically 

produced processing aids;

§ 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on 

processed products labeled as “organic” or “made with organic (specified 

ingredients or food group(s)).”

The following nonagricultural substances may be used as ingredients in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or 

food group(s))” only in accordance with any restrictions specified in this section.

Examples of specified restrictions addressing “other ingredients”:

Flavors, nonsynthetic sources only and must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.

Peracetic acid/Peroxyacetic acid (CAS # 79–21–0)—for use in wash and/or rinse 

water according to FDA limitations. For use as a sanitizer on food contact surfaces.

§ 205.606 Nonorganically produced agricultural products allowed as ingredients in 

or on processed products labeled as “organic.”

Only the following nonorganically produced agricultural products may be used as 

ingredients in or on processed products labeled as “organic,” only in accordance with 

any restrictions specified in this section, and only when the product is not commercially 

available in organic form.

Examples of specified restrictions addressing “other ingredients”:

(d) Colors derived from agricultural products—Must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.

(f) Fish oil (Fatty acid CAS #'s: 10417–94–4, and 25167–62–8)—stabilized with 

organic ingredients or only with ingredients on the National List, §§205.605 and 

205.606.

187
Appendix 2 – FDA terms 

Food additive. A substance, the intended use of which results or may reasonably be 

expected to result, directly or indirectly, either in the substance becoming a component of 

food or otherwise affecting the characteristics of food. A material used in the production of 

containers and packages is subject to the definition if it may reasonably be expected to 

become a component, or to affect the characteristics, directly or indirectly, of food packed 

in the container. A substance that does not become a component of food, but that is used 

in preparing an ingredient of the food to give a different flavor, texture, or other 

characteristic in the food, may be a food additive. 21 CFR § 170.3.

Secondary Direct Food Additive. This term is in the title of 21 CFR 173, which was 

created during recodification of the food additive regulations in 1977. A secondary direct 

food additive has a technical effect in food during processing but not in the finished food 

(e.g., processing aid). Some secondary direct food additives also meet the definition of a 

food contact substance. For more on food contact substances, consult the Food Contact 

Substance Notification Program.

Indirect Food Additive - In general, these are food additives that come into contact with 

food as part of packaging, holding, or processing, but are not intended to be added directly 

to, become a component, or have a technical effect in or on the food. Indirect food additives 

mentioned in Title 21 of the U.S. Code of Federal Regulations (21CFR) used in foodcontact articles, include adhesives and components of coatings (Part 175), paper and 

paperboard components (Part 176), polymers (Part 177), adjuvants and production aids

and sanitizers (Part 178). Currently, additional indirect food additives are authorized 

through the food contact notification program. In addition, indirect food additives may be 

authorized through 21 CFR 170.39.

Incidental additive. 21 CFR101.100(a)(3) Incidental additives that are present in a food at 

insignificant levels and do not have any technical or functional effect in that food. For the 

purposes of this paragraph (a)(3), incidental additives are:

(i) Substances that have no technical or functional effect but are present in a food by 

reason of having been incorporated into the food as an ingredient of another food, in 

which the substance did have a functional or technical effect.

(ii) Processing aids, which are as follows:

(a) Substances that are added to a food during the processing of such food but are 

removed in some manner from the food before it is packaged in its finished form.

(b) Substances that are added to a food during processing, are converted into 

constituents normally present in the food, and do not significantly increase the amount 

of the constitutents naturally found in the food.

(c) Substances that are added to a food for their technical or functional effect in the 

processing but are present in the finished food at insignificant levels and do not have 

any technical or functional effect in that food.

(iii) Substances migrating to food from equipment or packaging or otherwise affecting food 

that are not food additives as defined in section 201(s) of the act; or if they are food 

additives as so defined, they are used in conformity with regulations established pursuant 

to section 4.

188
GRAS - "GRAS" is an acronym for the phrase Generally Recognized As Safe. Under 

sections 201(s) and 409 of the FD&C Act, any substance that is intentionally added to food 

is a food additive, that is subject to premarket review and approval by FDA, unless the 

substance is generally recognized, among qualified experts, as having been adequately 

shown to be safe under the conditions of its intended use, or unless the use of the 

substance is otherwise excluded from the definition of a food additive. GRAS substances 

are distinguished from food additives by the type of information that supports the GRAS 

determination, that it is publicly available and generally accepted by the scientific 

community, but should be the same quantity and quality of information that would support 

the safety of a food additive. Additional information on GRAS can be found on the GRAS 

Notification Program page.

Appendix 3 – Materials Working Group

The Materials Working Group is an unaffiliated ad hoc committee of volunteers with 

technical and regulatory background. The MWG was initiated in November, 2007 following 

the NOSB meeting to work on clarifying the issues surrounding the definitions of 

“nonagricultural,” “synthetic” and “nonsynthetic,” and to provide the NOSB with 

recommendations and guidance documents relating to those definitions. Participation in the 

group is voluntary, open and available to any interested party.

The NOSB Handling Subcommittee wishes to thank members of the Materials Working 

Group for their help in putting together this Discussion Document.

Gwendolyn Wyard – Co-facilitator Kim Dietz – Co-facilitator

Brian Baker Johanna Mirenda

Harriet Behar Mary Mulry

Andrea Caroe Tony Pavel 

Katherine DiMatteo Richard Siegel

Lindsay Fernandez-Salvador Zea Sonnabend

John Foster Richard Theuer

Grace Gershuny Gay Timmons 

Daniel Giacomini Jessica Walden 

Katrina Heinze Julie Weisman 

George Kalogridis Darryl Williams

Nate Lewis 

Appendix 4 – Chart of § 205.605 and § 205.606 substances along with “other ingredients” 

identified in Technical Reviews and Petitions.

FDA 

Regulatory 

citation & 

Category

7 CFR 205.605 Other Ingredients (TAP, TR, 

Petition, NOSB Recommendation)

Comments

(a) Nonsynthetics allowed: 

Biological Materials

189
Animal 

enzymes—

(Rennet—

animals 

derived; 

Catalase—

bovine liver; 

Animal lipase; 

Pancreatin; 

Pepsin; and 

Trypsin)

2000 TAP: Enzyme preparations 

usually contain diluents, preservatives 

(to prevent microbial growth In liquid 

preparations), antioxidants, and other 

food grade substances consistent with 

current good manufacturing practice. 

Among the substances used in 

commercial rennet preparations 

include salt (sodium chloride), 

propylene glycol, sodium benzoate, 

and sodium propionate.

21 CFR 

184.1685

Rennet

21 CFR 

184.1034

Catalase

21 CFR 

184.1415

Animal lipase

21 CFR 

184.1583

Pancreatin

21 CFR 

184.1595

Pepsin

21 CFR 

184.1914

Trypsin

21 CFR 

184.

Dairy cultures. No mention of "other ingredients" 

(other than milk)

See 

specification 

sheets for 

Enzymes and 

Dairy Cultures

21 CFR 

184.

Enzymes—must 

be derived from 

edible, nontoxic 

plants, 

nonpathogenic 

fungi, or 

nonpathogenic 

bacteria.

See 

specification 

sheets for 

Enzymes and 

Dairy Cultures

Plant enzymes 1995 TAP: ". . . Carriers and 

stabilizers used to keep them moldfree and stable . . ."

Microbial 

enzymes

1995 TAP: "Preparations from 

microbial sources are the most 

important source of commercial 

enzymes and are produced from the 

fermentation of specifically selected 

nonpathogenic and nontoxicogenic 

strains of microorganisms. These 

microorganisms are grown on 

natural food grade substances 

(such as starch and corn meal) 

Specification 

sheets lists 

calcium sulfate 

and wheat 

(carrier) as 

ingredients 

used in 

combination 

with enzymes. 

See spec sheet 

190
under controlled conditions which 

prevent the introduction of undesirable 

microorganisms or other substances. 

Enzymes are recovered from the 

fermentation broth under mild 

conditions usually by mechanical 

separation means, such as filtration or 

centrifugation and then concentrated 

using ultrafiltration or evaporation. 

Any carriers, diluents, or 

processing aids used in the 

production of enzyme preparations 

are acceptable for general use in 

food, and the levels used do not 

exceed specified limits." 

"Preservatives are almost always 

added during processing, and 

optionally in the final preparation, to 

prevent microbial growth and to 

stabilize and maintain the desired 

enzymic activity. Proper and 

appropriate use of preservatives and 

stabilizers serve to protect the

consumer from unsafe or ineffective 

enzyme products. When the enzyme 

is intended for addition to food, all 

such additives and diluents must be 

acceptable to the FDA for use in food. 

They must be of food grade quality 

and the levels used must not exceed 

specified limits.” 2011 Enzymes TR: 

"Microbial enzymes used in food 

processing and are typically sold as 

enzyme preparations, which are 

mixtures with the desired enzyme 

activity that contain preservatives 

(such as boric acid and natamycin), 

stabilizers (such as salts and 

aminoacetic acid), and other 

metabolites of the production strain." 

"Substances used in commercial 

rennet preparations include salt 

(sodium chloride), propylene glycol, 

sodium benzoate, boric acid, and 

sodium propionate."

for Watson 

Enzymes. 

Example spec 

sheet for 

Marzyme 

Enzyme lists 

Sodium 

chloride, acetic 

acid and 

sodium acetate

Microorganisms

—any food 

grade bacteria, 

fungi, and other 

TAP: Only discusses enzymes, dairy 

cultures, and yeasts; PETITION: Miso 

- non-pathogenic fungi used for 

fermentation; Pre-gelatinized starch 

191
microorganism. added. 

21 CFR 

184.

Yeast—

nonsynthetic, 

growth on 

petrochemical 

substrate and 

sulfite waste 

liquor is 

prohibited 

Yeast, Autolysate, Brewer's, 

Nutritional - nothing added 

Yeast, Bakers - Yeast cake is mixed 

with oils, emulsifiers and water... 

(From TAP 1996) Yeast, Smoked - 

Hickory smoke added for flavor. Spec 

sheet included with TAP (1996) 

showing only yeast and Hickory 

smoke flavor.

(Autolysate; 

Bakers; 

Brewers; 

Nutritional; 

and Smoked—

non-synthetic 

smoke 

flavoring 

process must 

be 

documented)

Defined Substances

Acids (Alginic; 

Citric—produced 

by microbial 

fermentation of 

carbohydrate 

substances; and 

Lactic).

no "other ingredients"

21 CFR 

184.1011

Alginic acid no "other ingredients"

21 CFR 

184.1033

Citric acid 1995 TAP: "pure substance"

21 CFR

184.1061

Lactic acid TAP: NO additives noted; MSDS 

Indicates impurities in mfg proess 

possible (10-20% Lactic Acid lactate)

21 CFR 

184.1115

Agar-agar. 1995 TAP: no "other ingredients." 

2011 TR: no "other Ingredients."

21 CFR 

184.1155

Bentonite. 1995 TAP: no "other ingredients."

21 CFR 

184.1191

Calcium 

carbonate.

no "other ingredients"

21 CFR 

184.1193

Calcium chloride. No TAP; no "other ingredients"

21 CFR 

184.1230

Calcium 

sulfate—mined.

2001 TAP: Terra Alba as mined may 

contain certain impurities (limestone 

(calcium carbonate) and various 

naturally occurring forms of silica). No 

"added ingredients."

192
21 CFR 

172.620

Carrageenan. 1995 TAP: Carrageenan precipitated 

isopropyl alcohol may contain traces 

of residual isopropyl alcohol (21 CFR 

refers only to water extraction); may 

contain residues of epichlorhydrin 

from chlorinated antimicrobials. If 

recovered by drum drying, may 

contain up to mono- and diglycerides 

or up to 5% polysorbate 80. 

Chemicals may be added when 

standardizing carrageenan: sugar, 

sodium chloride, potassium chloride, 

phosphate salts, other hydro-colloids. 

2011 TER: No mention of "added 

ingredients."

Example 

Specification 

sheet: 

Standardized 

with Sucrose

21 CFR ??? 

GRAS

Diatomaceous 

earth—food 

filtering aid only.

Some DE is calcined in the presence 

of suitable flux (soda ash (sodium 

carbonate) or other alkaline salt)

21 CFR ??? 

GRAS

Egg white 

lysozyme (CAS # 

9001–63–2)

No specific combination products 

were identified for egg white lysozyme 

(or bromelain). Lysozyme is directly 

added to foods as a hydrochloride 

salt.

21 CFR 

184.

Flavors, 

nonsynthetic 

sources only 

and must not be 

produced using 

synthetic 

solvents and 

carrier systems 

or any artificial 

preservative.

The natural flavor does not contain 

propylene glycol, any artificial 

preservative, and is not extracted with 

hexane. Manufacturers must provide 

written documentation in their Organic 

Handling Plan, which shows that 

efforts were made toward the ultimate 

production of an organic natural flavor 

as listed in the stepwise progression 

below:

1. Natural flavor constituents and nonsynthetic carrier base and 

preservative agents;

2. Organic flavor constituents, organic 

carrier base, and organic preservative 

agents; and

3. Organic flavor constituents 

extracted using organically produced 

solvent, organic carrier base, and 

organic preservative agents.

21 CFR 

172.665

Gellan gum 

(CAS # 71010–

52–1)—high-acyl 

form only.

None shown in TAP, committee 

recommendation or petition

21 CFR 

184.1318

Glucono deltalactone—None shown inTAP. No committee 

recommendation. MSDS shows 99% 

193
production by the 

oxidation of Dglucose with 

bromine water is 

prohibited.

GDL in petition.

21 CFR 

186.1256

Kaolin. TAP MSDS shows 90-100% kaolin. 

No petition, or recommendations 

given

21 CFR 

184.1069

L-Malic acid 

(CAS # 97–67–

6).

TAP: No other ingredients identified; 

must be from microbial fermentation. 

21 CFR 

184.1443

Magnesium 

sulfate, 

nonsynthetic 

sources only.

TR: No other ingredients

21 CFR 

184.1540

Nitrogen—oilfree grades.No other Ingredients 

21 CFR ??? 

GRAS

Oxygen—oil-free 

grades.

No other Ingredients 

21 CFR ??? 

GRAS

Perlite—for use 

only as a filter 

aid in food 

processing.

No other Ingredients 

21 CFR 

184.1622

Potassium 

chloride.

No documents available on NOP 

website

21 CFR 

184.1634

Potassium 

iodide.

No other Ingredients 

21 CFR 

184.1736

Sodium 

bicarbonate.

1995 TAP: No combinations listed. 

One reviewer states: "As with all 

synthetic inorganic salts, source must 

be food grade. In addition each lot 

should be analyzed for toxic element 

concentrations (mercury, lead, 

cadmium, arsenic, thallium and 

antimony) and a near zero tolerance 

adopted.

21 CFR 

184.1742

Sodium 

carbonate.

1995 TAP: No combinations listed. 

One reviewer states: "As with all 

synthetic inorganic salts, source must 

be food grade. In addition each lot 

should be analyzed for toxic element 

concentrations (mercury, lead, 

cadmium, arsenic, thallium and 

antimony) and a near zero tolerance 

adopted.

21 CFR 

184.1099

Tartaric acid—

made from grape 

wine.

1995 TAP: 

194
Waxes—

nonsynthetic 

(Carnauba wax; 

and Wood resin).

Wax 2007 TAP: "Shellac is used as a 

hard protective coat, and will rapidly 

harden if not kept in a solvent. 

Aqueous lac will also be combined 

with various synthetic preservatives 

such as phenol, or the mixed methyl 

and propyl esters of p-hydroxybenzoic 

acid. It is almost always used with 

pure ethyl alcohol, but will 

occasionally isopropyl alcohol is used 

as a solvent. Often used with wood 

resins. Ammonium soap is used as a 

flowing and solidifying agent with 

wood resin and shellac."

21 CFR 

184.1978

Carnauba wax 1996 TAP ("Fruit Waxes"): No other 

Ingredients 

21 CFR 

172.210

Wood rosin 1996 TAP ("Fruit Waxes"): No other 

Ingredients 

(b) Synthetics allowed: 

Sanitizers, other Secondary 

Direct Food Additives

Sanitizer 

examples and 

common "other 

ingredients" are 

not presented 

here.

21 CFR 

186.1750

Acidified 

sodium 

chlorite—

Secondary 

direct 

antimicrobial 

food treatment 

and indirect 

food contact 

surface 

sanitizing. 

Acidified with 

citric acid only.

21 CFR 

173.325

Chlorine 

materials—

disinfecting and 

sanitizing food 

contact 

surfaces, 

(Calcium 

hypochlorite; 

2006 TR: "products contain no other 

active ingredients and contain no inert 

ingredients other than water"

Except, That, 

residual 

chlorine levels 

in the water 

shall not 

exceed the 

maximum 

residual 

195
Chlorine 

dioxide; and 

Sodium 

hypochlorite).

disinfectant 

limit under the 

Safe Drinking 

Water Act

21 CFR ??? Calcium 

hypochlorite

21 CFR 

186.1750

Sodium 

hypochlorite

21 CFR 

178.1010

Chlorine dioxide

21 CFR 

184.1366

Hydrogen 

peroxide.

21 CFR 

184.1563

Ozone. Petition includes oxygen and air as 

potential secondary ingredients; no 

other ingredients noted

21 CFR 

178.1010

Peracetic 

acid/Peroxyacet

ic acid (CAS # 

79–21–0)—for 

use in wash 

and/or rinse 

water according 

to FDA 

limitations. For 

use as a 

sanitizer on 

food contact 

surfaces.

Original petition unable to obtain from 

NOP website; TAP Crops and 

Livestock: Stabilizers are 

acknowledged to be not considered in 

the review; TAP Processing: HEDP, 

dipicolini acid (2, 6-

pyridinedicarboxylic acid), sulfuric 

acid, octanoic acid, peroxyoctanoic 

acid, sodium 1-octanesulfonate - 

mentioned in TAP but not evaluated to 

OFPA and the NL; HEDP mentioned 

in TAP reviews Committee 

recommendation.

21 CFR 

173.370

Acetic acid

21 CFR 

184.1005

Hydrogen 

peroxide

No TAP, committee recommendation, 

or petition shown. 

21 CFR 

184.1366

HEDP (1-

hydroxyethyliden

e-1,1-

diphosphonic 

acid)

21 CFR 

178.1010

Sulfuric acid

21 CFR 

184.1095

Octanoic acid

21 CFR 

184.1025

21 CFR 

182.1073

Phosphoric 

acid—cleaning of 

food-contact 

surfaces and 

TAP: Always combined with 

surfactant. Naphthalenesulfonic acid, 

sodium dodecylbenzene sulfonic acid, 

carboxylic acids, citric acid, lactic acid, 

196
equipment only. isopropyl alcohol, mention of FDA 

approved solutions, EDTA 

ethylenediaminetetraacetic acid 

21 CFR 

173.310

Cyclohexylamine 

(CAS # 108–91–

8)—for use only 

as a boiler water 

additive for 

packaging 

sterilization.

No "other ingredients"

21 CFR 

173.310

Diethylaminoeth

anol (CAS # 

100–37–8)—for 

use only as a 

boiler water 

additive for 

packaging 

sterilization.

No "other ingredients." Blended with 

sodium zeolite softened water.

21 CFR 

173.310

Octadecylamine 

(CAS # 124–30–

1)—for use only 

as a boiler water 

additive for 

packaging 

sterilization.

No "other ingredients"

Nutrient vitamins and 

minerals

Nutrient vitamin 

ingredients

21 CFR 

184.1930

Vitamin A No other ingredients mentioned in 

TAP

21 CFR 

184.1950

Vitamin D No other ingredients mentioned in 

TAP

USP/FCC Vitamin K1

(Phylloquinone) 

[required per 21 

CFR 107.100(c)]

No other ingredients mentioned in 

TAP

Vitamin K 

[Menaquinone-7 

]

No other ingredients mentioned in 

TAP

[GRN No. 245 

submitted & 

withdrawn]

21 CFR 

182.8890

Vitamin E 

[tocopherols]

No other ingredients mentioned in 

TAP

21 CFR 

182.8892

Vitamin E 

[alphatocopherol 

acetate]

No other ingredients mentioned in 

TAP

21 CFR Ascorbic acid No other ingredients mentioned in 

197
182.8013 TAP

21 CFR 

182.3189

Calcium 

ascorbate

No other ingredients mentioned in 

TAP

21 CFR 

182.3731

Sodium 

ascorbate

No other ingredients mentioned in 

TAP

21 CFR 

184.1875

Thiamine 

hydrochloride

No other ingredients mentioned in 

TAP

21 CFR 

184.1878

Thiamine 

mononitrate

No other ingredients mentioned in 

TAP

21 CFR 

184.1695

Riboflavin No other ingredients mentioned in 

TAP

21 CFR 

184.1697

Riboflavin-5'-

phosphate, 

sodium

No other ingredients mentioned in 

TAP

21 CFR 

184.1676

Pyridoxine 

hydrochloride

No other ingredients mentioned in 

TAP

21 CFR 

184.1945

Vitamin B12 No other ingredients mentioned in 

TAP

21 CFR 

184.1530

Niacin No other ingredients mentioned in 

TAP

21 CFR 

184.1535

Niacinamide No other ingredients mentioned in 

TAP

21 CFR 

172.345

Folic acid No other ingredients mentioned in 

TAP

21 CFR 

184.1212

Calcium 

pantothenate

No other ingredients mentioned in 

TAP

21 CFR 

182.8159

Biotin No other ingredients mentioned in 

TAP

21 CFR 

182.8890

Tocopherols—

derived from 

vegetable oil 

when rosemary 

extracts are not 

a suitable 

alternative.

No other ingredients mentioned in 

TAP

21 CFR ??? 

GRAS

Activated 

charcoal (CAS 

#s 7440–44–0; 

64365–11–3)—

only from 

vegetative 

sources; for use 

only as a filtering 

aid.

Pure carbon; no other ingredients

Alginates. Alginates are produced from alginic

acid and various alkaline elements 

(pH control agents). The pH control 

agents (are) ammonia, calcium 

198
hydroxide, potassium hydroxide, 

sodium hydroxide. No "other 

ingredients" mentioned.

21 CFR 

184.1133

Ammonium 

alginate

21 CFR 

184.1187

Calcium alginate

21 CFR 

184.1610

Potassium 

alginate

21 CFR 

184.1721

Sodium alginate

21 CFR 

184.1135

Ammonium 

bicarbonate—for 

use only as a 

leavening agent.

No TAP Review available; this 

substance is a single entity

21 CFR 

184.1137

Ammonium 

carbonate—for

use only as a 

leavening agent.

No TAP Review available; this 

substance is a single entity

21 CFR 

182.8013

Ascorbic acid. 1995 TAP: no "other ingredients"

21 CFR 

184.1195

Calcium citrate. 1995 TAP: no "other ingredients"

21 CFR 

184.1205

Calcium 

hydroxide.

1995 TAP: no "other ingredients"

21 CFR 

182.8217

Calcium 

phosphates 

(monobasic, 

dibasic, and 

tribasic).

1995 TAP: no "other ingredients"

21 CFR 

182.6215

Monobasic 

calcium 

phosphate

1995 TAP: no "other ingredients"

21 CFR 

182.1217

Dibasic calcium 

phosphate

1995 TAP: no "other ingredients"

21 CFR 

182.1217

Tribasic calcium 

phosphate

1995 TAP: no "other ingredients"

21 CFR 

184.1240

Carbon dioxide. 1995 & 2006 Tap: No "other 

ingredients"

21 CFR ??? 

GRAS

Cellulose—for 

use in 

regenerative 

casings, as an 

anti-caking agent 

(non-chlorine 

bleached) and 

filtering aid.

Petition: 100% cellulose (no "other 

ingredients"). 2001 TAP: "All additives 

must appear on the National List"

199
21 CFR 

184.

Ethylene—

allowed for 

postharvest 

ripening of 

tropical fruit and 

degreening of 

citrus.

No "other ingredients"

21 CFR 

184.1307

Ferrous sulfate—

for iron 

enrichment or 

fortification of 

foods when 

required by 

regulation or 

recommended 

(independent 

organization).

MSDS in TAP states composed of 

Iron II sulfate hydrate and sulfuric acid 

(2+) salt. No petition, or committee 

recommendation.

21 CFR 

184.1505

Glycerides 

(mono and di)—

for use only in 

drum drying of 

food.

None listed in TAP, or petition. No 

committee recommendation. 

21 CFR 

182.1320

Glycerin—

produced by 

hydrolysis of fats 

and oils.

No TAP, committee recommendation, 

or petition shown. 

21 CFR 

184.1425

Magnesium 

carbonate— 

No" other ingredients" mentioned in 

TAP; but various grades mentioned

for use only in 

agricultural 

products 

labeled “made 

with organic 

(specified 

ingredients or 

food group(s))” 

21 CFR 

184.1426

Magnesium 

chloride—

derived from sea 

water.

No" other ingredients" mentioned in 

TAP

21 CFR 

184.1440

Magnesium 

stearate— 

No" other ingredients" identified in 

TAP, but identified as a potential 

"incidental" additive itself in the TAP 

review

for use only in 

agricultural 

products 

labeled “made 

with organic 

(specified 

ingredients or 

food group(s))” 

21 CFR 

184.1595

Pectin (lowmethoxy).No "other ingredients" 

200
21 CFR 

184.1077

Potassium acid 

tartrate.

No "other ingredients" 

21 CFR 

184.1619

Potassium 

carbonate.

No "other ingredients" 

21 CFR 

184.1625

Potassium 

citrate.

1995 TAP: no "other ingredients"

21 CFR 

184.1631

Potassium 

hydroxide—

prohibited for 

use in lye 

peeling of fruits 

and vegetables 

except when 

used for peeling 

peaches during 

the Individually 

Quick Frozen 

(IQF) production 

process.

No "other ingredients" 

21 CFR 

184.1634

Potassium 

iodide— 

No "other ingredients" for use only in 

agricultural 

products 

labeled “made 

with organic 

(specified 

ingredients or 

food group(s))” 

21 CFR 

184.

Potassium 

phosphate— 

No "other ingredients" for use only in 

agricultural 

products 

labeled “made 

with organic 

(specific 

ingredients or 

food group(s))” 

21 CFR 

184.

Monobasic 

potassium 

phosphate

No "other ingredients" 

21 CFR 

182.6285

Dibasic 

potassium 

phosphate

No "other ingredients" 

21 CFR 

184.

Tribasic 

potassium 

phosphate

No "other ingredients" 

21 CFR 

172.480

Silicon dioxide. Petition: The 2010 petition to remove 

does not mention other ingredients. 

TR: The 1995 and 2010 TRs do not 

mention other ingredients.

201
21 CFR 

182.1087

Sodium acid 

pyro-phosphate 

(CAS # 7758–

16–9) –for use 

only as a 

leavening agent.

Petition: The 2002 petition and 2009 

petition to for expanded use do not 

mention other ingredients. TR: The 

2002 and 2010 TRs do not mention 

other ingredients.

21 CFR 

184.1751

Sodium citrate. TR: The 1995 TAP lists no other 

ingredients.

21 CFR 

184.1763

Sodium 

hydroxide—

prohibited for 

use in lye 

peeling of fruits 

and vegetables.

1995 TAP: No combinations listed. 

One reviewer states: "As with all 

synthetic inorganic salts, source must 

be food grade. In addition each lot 

should be analyzed for toxic elemnt 

concentrations (mercury, lead, 

cadmium, arsenic, thallium and 

antimony) and a near zero tolerance 

adpted.

21 CFR 

182.8778

Sodium 

phosphates—for 

use only in dairy 

foods.

Petition: The 2001 petition for sodium 

hexametaphosphate mentions other 

sodium phosphates. TR: The 2001 

TAP review states: Sodium 

phosphates are combined with 

calcium phosphates as leavening 

agents (Horsford, 1864; Ellinger, 

1972; FMC, no date). Sodium 

orthophosphates are often combined 

with insoluble sodium metaphosphate 

(IMP) and various polyphosphates 

(Ellinger, 1972; FMC, no date). The 

addition of other salts, such as sodium 

chloride, can have a synergistic effect 

on water-holding capacity (Gordon 

and Klimek, 2000). Typical 

commercial mixtures contain 30-60% 

soluble orthophosphates and 40-70% 

IMP (Gard, 1996). Starches are often 

used as carriers (Ashford, 1994). 

Trisodium phosphate used for 

cleaning is often combined with 

sodium hypochlorite (bleach) 

(Ashford, 1994). Sodium aluminum 

phosphate and sodium acid 

pyrophosphates are also used as a 

leavening agents (Food Chemicals 

Codex, 1996). The sodium 

phosphates are often used in 

combination with various gels such as 

agar, alginates, carageenan, pectins, 

and various gums (Ellinger, 1972). 

202
The previous sodium phosphates TAP 

Review (NOSB, 1995) only reviewed 

the forms mono-, di-, and tri-sodium 

phosphates. . This TAP Review does 

not cover other forms such as 

metaphosphates, pyrophosphates, 

polyphosphates, or combinations of 

sodium phosphates with any 

elemental constituents other than 

hydrogen. 

21 CFR 

182.3862

Sulfur dioxide—

for use only in 

wine labeled 

“made with 

organic grapes,”.

Petition: The 2010 petition does not 

mention other ingredients. TR: The 

1995 TAP does not mention 

combinations. The 2011 TR mentions 

citric acid and carbon dioxide, both of 

which appear on 205.605.

Provided, That, 

total sulfite 

concentration 

does not 

exceed 100 

ppm

21 CFR 

184.1099

Tartaric acid—

made from malic 

acid.

21 CFR 

182.6789

Tetrasodium 

pyrophosphate 

(CAS # 7722–

88–5)—for use 

only in meat 

analog products.

Petition not linked on the NOP 

website. The 2002 TAP review states: 

"Tetrasodium pyrophosphate is 

combined with calcium phosphates as 

leavening agents (Ellinger, 1972; 

FMC, no date). TSPP has a 

synergistic effect on various foaming 

agents, such as alkyl polycarboxylates 

and triethyl citrate (Sutton, 1960). 

Other salts, such as sodium chloride, 

can have a synergistic effect on waterholding capacity of sodium 

phosphates (Gordon and Klimek, 

2000)."

21 CFR 

172.695

Xanthan gum. 1995 TAP review by Steven Harper 

mentions that isopropyl alcohol is 

used to extract and purify xanthan 

gum and it is possible that trace 

amounts remain. FDA has limits for 

residual isopropyl.

7 CFR 205.606 Other Ingredients (TAP, TR, Petition, NOSB 

Recommendation)

a) Casings, from processed 

intestines.

No technical report requested. No other ingredients 

mentioned in the petition.

(b) Celery powder. The fresh celery is cleaned, concentrated by 

evaporation, heated and dried. There are no other 

chemicals or preserving agents used in the 

manufacture process.

203
(c) Chia ( Salvia hispanica L. 

).

Spanish sage. Petition: No other ingredients 

mentioned. No TR requested.

(d) Colors derived from 

agricultural products.

See specific colors as follows:

(1) Annatto extract color 

(pigment CAS # 1393–63–

1)—water and oil soluble.

NOSB recommended removal from the NL

(2) Beet juice extract color 

(pigment CAS # 7659–95–2).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73."

(3) Beta-carotene extract 

color, derived from carrots or 

algae (CAS # 1393–63–1).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 

"Beta-carotene and maltodextrin" in CWS powder. 

2009 Petition: "The main articles of commerce are 

suspensions in food grade vegetable oil or the liquids in 

oil made dispersable in water using food grade 

emulsifiers."

(4) Black currant juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: ". . . contains only the natural constituents of 

the processed black currant. Citric acid and invert 

sugar may be used for standardization purposes and 

these ingredients are GRAS."

(5) Black/Purple carrot juice 

color (pigment CAS #'s: 528–

58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 

134–04–3).

Petitions: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 

pH of flavor is less than 4.0; since carrots are a low-cid 

food, a food grade acid is being added (presumably 

citric acid).

(6) Blueberry juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(7) Carrot juice color (pigment 

CAS # 1393–63–1).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(8) Cherry juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(9) Chokeberry—Aronia juice 

color (pigment CAS #'s: 528–

58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 

Petitioner A: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 

204
134–04–3). Petitioner B: "Citric acid and invert sugar may be used 

for standardization purposes and these ingredients are 

GRAS."

(10) Elderberry juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(11) Grape juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(12) Grape skin extract color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73."

(13) Paprika color (CAS # 

68917–78–2)—dried, and oil 

extracted.

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 

NOSB: "Organic Oil must be used for the oil 

extraction."

(14) Pumpkin juice color 

(pigment CAS # 127–40–2).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(15) Purple potato juice 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(16) Red cabbage extract 

color (pigment CAS #'s: 528–

58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 

134–04–3).

Petitioner A: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 

Petitioner B: "Citric acid and invert sugar may be used 

for standardization purposes and these ingredients are 

GRAS."

(17) Red radish extract color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73."

(18) Saffron extract color 

(pigment CAS # 1393–63–1).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73."

(19) Turmeric extract color 2007 Petition: "Specific formulation is withheld as a 

205
(CAS # 458–37–7). trade secret pursuant to 21CFR20.61. The 

characterizing principles and/or other components of 

this color blend are approved and are in compliance 

with 21CFR73."

(e) Dillweed oil (CAS # 8006–

75–5).

No "other ingredients."

(f) Fish oil (Fatty acid CAS 

#'s: 10417–94–4, and 25167–

62–8)—stabilized with organic 

ingredients or only with 

ingredients on the National 

List, §§205.605 and 205.606.

None of the other ingredients are disclosed in the 

Petition.

(g) Fortified cooking wines.

(1) Marsala. No sulfites; grapes and yeast fermented, salt added, 

bentonite filtered.

(2) Sherry. No sulfites; grapes and yeast fermented, salt added, 

bentonite added, filtered with diatomaceous earth.

(h) Fructooligosaccharides

(CAS # 308066–66–2).

Sucrose is converted by a fermentation reaction to 

short-chain molecules containing two, three, or four 

fructose units. No “other ingredients.”

(i) Galangal, frozen.

(j) Gelatin (CAS # 9000–70–

8).

Specifically states in TAP that it is often combined with 

other ingredients and each of these other ingredients 

would need to appear on the NL or be organic. 

Isinglass (made from fish bladders) can contain tartaric 

acid to balance pH as a preservative. Metabisulfite as a 

stabilizer. Bentonite for juice clarification. Sucrose 

added to increase set time. Capsules use hardening 

agents like glycerine, various alcohols, propylene 

glycol, sucrose and acacia. Starches for secondary as 

disintegrants. Formaldehyde and glutaraaldehyde used 

as hardening agents for encapsulation of flavors. 

Surfactants such as polysorbates used for increased 

dispersion. Substances considered GRAS for use in 

geletin capsules succinylated gelatin, arabinogalactan, 

silicon dioxide, glutataldehyde, n-Octyl alcohol, 

petroleum wax, polyacrylamide, and terpine resin.

(k) Gums—water extracted 

only (Arabic; Guar; Locust 

bean; and Carob bean).

None shown in TAP. No petition, or committee 

recommendation.

Gum Arabic

Guar Gum

Locust bean gum

Carol bean gum

(l) Hops ( Humulus luplus ).

(m) Inulin-oligofructose 

enriched (CAS # 9005–80–5).

Kafir Lime Leaves None shown in petition, committee proposal, or formal 

206
recommendation. No TAP.

(n) Kelp—for use only as a 

thickener and dietary 

supplement.

None shown in TAP. No committee recomendationm, 

or petition. 

(o) Konjac flour (CAS # 

37220–17–0).

No petition, TAP, or committee recommendation. 

(p) Lecithin—de-oiled. No" other ingredients"

(q) Lemongrass—frozen. No" other ingredients"

(r) Orange pulp, dried. No" other ingredients"

(s) Orange shellacunbleached (CAS # 9000–

59–3).

No information available on NOP website

(t) Pectin (high-methoxy).* TAP on NOP website is for low-methoxy pectin; No 

"other ingredients" mentioned

(u) Peppers (Chipotle chile). No" other ingredients"

(v) Seaweed, Pacific kombu.

(w) Starches.

(1) Cornstarch (native). No "other ingredients"

(2) Rice starch, unmodified 

(CAS # 977000–08–0)—for 

use in organic handling until 

June 21, 2009.

Petition: "Rice starch interacts with the other thickening 

agents to create a unique gelation agent. The 

combination of rice starch, locust bean gum, pectin, 

and carrageenen reinforce the gels of each component, 

provide an elastic texture and prevents syneresis 

separation of water). " No TR requested.

(c) Chia ( Salvia hispanica L. 

).

Spanish sage. Petition: No other ingredients 

mentioned. No TR requested.

(3) Sweet potato starch—for 

bean thread production only.

Petition: Is not linked on the NOP's website. No TR 

requested.

(x) Tragacanth gum (CAS #–

9000–65–1).

Petition: The 2007 petition mentions other gums on 

606. TR: The 1995 TAP review lists no combinations. 

No TR requested for the 2007 petition.

(y) Turkish bay leaves. Petition: The 2006 petition does not mention other 

ingredients. No TR requested.

(z) Wakame seaweed 

(Undaria pinnatifida).

(aa) Whey protein 

concentrate.

No other ingredients mentioned in petition or 

recommendation

*Specification sheets often indicate pectin is standardized with sugar

207
208
National Organic Standards Board

Policy Development Subcommittee 

Proposal: Conflict of Interest/Ethics

July 9, 2012 

I. Introduction

The National Organic Standards Board (NOSB) Policy Development Subcommittee 

(PDS) proposes revising the Conflict of Interest (COI) and Ethics sections of December 

2, 2011 NOSB’s Policy and Procedures Manuel (PPM). The proposed changes are due 

to an on-going dialogue with the organic community, the general public, NOSB 

members, and the National Organic Program (NOP).

PDS further affirms that the proposed changes have evolved and been vetted through 

the public process, NOSB, and NOP on several occasions over the last year. The 

proposed recommendation proposal includes (1) COI definitions, (2) ethics revisions, 

and (3) outlined procedures for declaring, evaluating, and acting upon a COI. 

PDS presented recommendations at the November, 2011 NOSB meeting in Savannah,

Georgia. The need for further information and dialogue by some NOSB members

resulted in the PDS chair deferring the recommendation at the spring 2012 meeting in 

Albuquerque, New Mexico. The tabling of the COI document has allowed for additional 

modifications to the COI document. Nevertheless, the proposed additions should 

provide greater transparency and expectations related to NOSB members’ work on 

behalf of the organic community.

II. Background

The NOSB operates under the authority of Organic Foods Production Act (OFPA) and 

the Federal Advisory Committee Act (FACA). The NOSB recognizes that members have 

been specifically appointed to the NOSB to provide advice and counsel to the Secretary 

of Agriculture concerning policies related to the development of organic standards and 

the creation of amendments to the National Organic Program’s National List. NOSB 

members have been appointed because they represent various interests involved in the 

organic community, thus enabling them to advise the Secretary of Agriculture on the 

implementation of the OFPA. 

The statutory composition of the NOSB is 15 members. OFPA describes the required 

composition of the Board as follows: (1) four members who own or operate an organic 

farming operation, (2) three members with expertise in areas of environmental 

protection and resource conservation, (3) three members who represent the public 

interest or consumer interest groups, (4) two members who own or operate an organic 

handling operation, (5) one member who owns or operates a retail establishment with 

significant trade in organic products, (6) one member with expertise in the fields of 

toxicology, ecology, or biochemistry; and (7) one certifying agent. Thus, NOSB 

members are appointed to represent the interests of the organic community.

209
NOSB members – like most federal advisory board members – are chosen specifically 

because of their professional expertise within a given area. Since NOSB members 

represent sectors of the industry directly impacted by the Board’s decisions, it is 

necessary to maintain a clear and detailed COI and Ethics policy. Therefore, PDS 

affirms that we seek to update the Board’s policy and procedures on COI and Ethics. 

III. Relevant Areas of the Rule

The OFPA establishes the NOSB at § 2119 (7 U.S.C. 6518) (a). It reads, “The 

Secretary shall establish a NOSB in accordance with the Federal Advisory Committee 

Act (5 U.S.C. App. 2 et seq.) (hereafter referred to in this section as the "Board") to 

assist in the development of standards for substances to be used in organic production 

and to advise the Secretary on any other aspects of the implementation of this title.” 

The 2011 NOSB Revised Policy and Procedures Manual (PPM), dated December 2, 

2011, on pages 5-11 sets forth the current NOSB’s PPM. 

IV. Discussion

COI and Ethics has been an issue since the beginning of humankind. It will probably 

continue in the foreseeable future. As it relates to the organic community, a periodical 

review and revision of NOSB’s PPM helps to provide greater clarity, transparency, and 

confidence in the NOSB decisions. 

An alternative approach for the PDS would be to keep the current COI and Ethics 

policy. However, an enhanced COI policy should help the Board, NOP, and 

USDA/Agricultural Marketing Service (AMS) in their continued responsiveness to the 

organic community’s feedback and address a number of opportunities for enhanced 

clarity, particularly with regard to the specific procedures to be followed in declaring, 

evaluating, and acting upon COI and Ethics matters. 

According to 41 CFR §102-3.105(a-j), federal advisory committees’ agency heads are 

responsible for assuring that the interests and affiliations of advisory committee 

members are reviewed for conformance with applicable COI statutes, and regulations 

issued by the U.S. Office of Government Ethics (OGE), including any supplemental 

agency requirements, and other Federal ethics rules. For the NOSB, the agency is the 

AMS and the NOP. 

The USDA Office of Ethics’ AMS Representative has recently provided the opinion that 

representative members on the NOSB are specifically appointed to provide the points of 

views of non-governmental entities or of a recognizable group of persons (1) who own 

or operate an organic farming operation, (2) with expertise in areas of environmental 

protection and resource conservation, (3) who represent the public interest or 

consumer interest groups, (4) who own or operate an organic handling operation, (5) 

who owns or operates a retail establishment with significant trade in organic products, 

(6) with expertise in the fields of toxicology, ecology, or biochemistry; and (7) from the 

certifiers sector. These representative members have interests in the subject matter 

under NOSB charge. Representatives serve as the voice of groups or entities with a 

financial or other stake in a particular matter before an advisory committee or board. 

210
Representative members are not covered by the “Standards of Ethical Conduct for 

Employees of the Executive Branch” or many of the Federal ethics laws and regulations 

that other Board member types are (i.e., Special Government Employees - SGE’s). 

However, this exemption for NOSB representatives does not mean that COI and Ethics 

should not be addressed. The Ethics Representative opinion specifically referenced § 

102–3.105(h), stating that, “Therefore, AMS, and NOP managers have the authority to 

address potential conflicts of interest of representative members of the NOSB.” (E-mail 

communication from Mary Royster, May 17, 2012). 

Criteria for Effective COI Definitions and Procedures

The organic community has voiced great interest in transparency, clear COI definitions, 

and procedures for NOSB members in disclosing a COI or potential COI in order to

continue the strong public support and confidence in the Board. The challenge is that 

Board members are appointed in part because of their interests. As such, the 

difference between an acceptable interest and a COI must be defined in a way that can 

be practically applied when Board members are faced with specific proposals at Board 

meetings. The NOSB’s PDS has suggested that the goal for any COI policy is to: 

prevent overt advocacy for direct financial gain and the appearance of self-interest or 

the appearance of wrongful activity. An important part of this is acknowledging that COI 

is as much about the appearance of a personal conflict and loss of impartiality as it is 

about actual direct interest. Given this, a key criterion for an effective COI definition is 

that it delineates the interests carried by NOSB members in the interest of a 

represented group, from interests that will directly and disproportionally benefit the 

NOSB member personally. 

A second criterion for an effective COI definition is that it must be clearly understood by 

Board members in a way that can be applied in considering specific proposals facing 

the Board and is easily understood by the public. In addition to these criteria, the 

procedural steps must be clear, easy to follow, and give both the Board members and 

NOP sufficient time to consider the presence of COI, and to determine the path forward 

should a COI be declared. Given this background, the NOP accepts responsibility for, 

in collaboration with the NOSB, reviewing, updating the definitions, outlining procedures 

related to COI and Ethics for the possible inclusion into the NOSB’s PPM. 

V. Recommendations

The proposed recommendations to NOSB’s Policy and PPM dated December 2, 2011 

are: 

Recommendation #1

Page 2 (Table of Contents)

Change page numbers and captions based on approved changes.

 

Recommendation #2 

211
Page 5(NOSB Mission Statement)

Revise the NOSB Mission Statement to read: 

a. To provide effective and constructive advice, clarification, and guidance to the 

Secretary of Agriculture concerning the NOP and any other aspects of the 

implementation of the OFPA of 1990. 

b. Add the word proposed before inclusion on line six (6) of NOSB Mission 

Statement thus it reads proposed inclusion. 

Recommendation #3

Page 7 (Under Duty and Loyalty) 

Add

Balance personal perspectives and interests - Personal perspectives and interests are a 

vital source of knowledge to bring to the Board’s deliberative process. These 

perspectives and interests must, however, be balanced with the perspectives and 

interests of the entire community/industry. Board recommendations should be based 

upon what is best for the entire community/industry. Recommendations should not be 

based on personal interests, or special interests of specific organizations, states or 

regions.

Exhibit commitment – Board members should represent the interests of all people 

served by this organization and not favor any individual’s or group’s particular special 

interest. Approach all Board issues with an open mind and be prepared to make the 

best decisions for everyone involved. Focus efforts on the mission of the community 

served and not on personal or organization’s goals. Being first and foremost a voice for 

the community, and ensure that the Board is operating well and in the best interests of 

the community we serve. 

Recommendation #4

Page 7 (Duty and Loyalty) 

Move this section after “Maintaining Professional and Ethical Standards” 

Recommendation #5

Page 8 (Duty and Loyalty) 

a. Change the section title entitled “Recognize corporate opportunity” to 

“Disclosure of financial opportunity”

b. Thus, the section should read

Disclosure of financial opportunity - Before a Board member vote upon an issue in 

which they have a direct financial interest, said Board member must disclose the 

transaction to the NOP in sufficient detail and adequate time to enable the NOP to 

determine whether said Board member can discuss or vote on that particular matter. 

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Recommendation #6 

Page 8 (Professional Conduct) 

Revised line nine (9) under Professional Conduct to read 

NOSB members shall act impartially and not give preferential treatment to any 

organization or individual. The impartiality includes representing their own organizations 

at Board meetings. If a Board member voices support for comments published by their 

own organization/employer, or an organization she/he is closely affiliated with (e.g., on 

the Board of Directors, conduct significant consulting for), she/he is to state that 

affiliation when making comments.

Recommendation #7

Page 9 (Conflict of Interest) 

Revised line 14 to read 

.............. NOP will determine whether it is appropriate for the member to vote 

RATHER than the Board may determine if it is appropriate for the member to vote. 

Recommendation #8 

Page 9

The definitions are proposed for page 9 of PPM. 

Conflict of Interest -The term “conflict of interest” is defined as a situation in which there 

is an actual or potential direct financial interest of a Board member, or person or entity 

associated with a Board member, which could impair the individual's objectivity or which 

has the potential to create an unfair competitive advantage. Persons or entities 

associated with a Board member include: spouse; minor child; general partner; an 

organization or entity which the Board member serves as officer, director, trustee, 

general partner or employee; and a person with whom the Board member is negotiating 

for or has an arrangement concerning prospective employment. A financial interest by 

such an associated person or entity can disqualify a Board member to the same extent 

as if they were the Board member's own interests.

Potential Conflict of Interest - A “potential conflict of interest” is defined as the 

appearance of a loss of impartiality based on the relationship outlined in the proposed 

definition of a conflict of interest.

Recommendation #9

Delete the term “direct financial gain” since it is covered in the definition of COI when it 

states “direct financial interest.” 

Recommendation #10

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We recommend the added section below.

Procedures for Declaring and Evaluating a COI 

Level #1 (Subcommittee) 

1. At the subcommittee level, as topics are added to the subcommittee’s work plan, 

each Board member is to evaluate possible COI or potential COI related to the 

topic. If the Board member has a COI or potential COI, the member should 

disclose the COI to said subcommittee and NOP. After a determination is made 

by NOP regarding the participation of said Board member. NOP final decision on 

all COI will be clearly recorded in the minutes. 

2. It is primarily the Board member’s responsibility to self-assess whether conflicts 

or potential conflicts exist. If one Board member believes that another Board 

member has a conflict, she/he should raise that one-on-one with the Board 

member involved or to the NOP’s Designated Federal Officer (DFO). In this 

case, the NOP will work with said Board member to determine whether a COI 

exists and if recusal is warranted; the Board member raising the issue against 

another Board member will not be involved in the determination of a COI or a 

potential COI. 

3. As soon as the final agenda and list of proposals for the Board’s public meeting 

has been set, all Board members will re-assess possible COI because of their 

personal interests or organizational affiliation or relationships. 

In general, COI’s can lead to a recusal from the discussion and vote associated with the 

conflict. In the case of a potential COI, as defined above, the potential conflict may not 

be deemed significant enough to warrant recusal. If a Board member believes that 

she/he may have conflict(s) based on the definition above, she/he contact the DFO as 

soon as possible (within three working days) stating

a. the conflict(s) or potential conflict(s) that could exists and

b. the proposal (s) it relates to.

In the communication, said Board member is to state whether the she/he wants to 

recuse herself or himself without discussion, or, if the Board member wants the NOP’s 

opinion on the need for recusal based on the nature of the potential COI. (Note: If said 

Board member chooses to recuse her/him, NOP will accept that without explanation. If 

the member is unsure, the NOP may ask for additional information about the conflict(s) 

to make a determination.

If an NOP opinion is needed, NOP will make the determination and communicate the 

decision back to the Board member expeditiously (generally within three working days) 

after consulting with the DFO and/or USDA Office of Ethics, if needed. 

Level 2 (Biannual Meetings)

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1. At the biannual meeting, in opening the discussion of each proposal or issue, the 

Subcommittee Chair will ask Board members to declare any recusal decisions 

related to the proposal(s) or issue(s). At this time, Board members shall share 

the determination made before the meeting. Immediately before the vote, the 

Board Chair will repeat the names of people who will not be voting on the 

motion(s); this will be captured in the voting record and minutes. The Board 

member is not required to share the nature of the COI at the meeting; it is 

sufficient to state that a conflict exists, and that she/he is recusing 

herself/himself. The only time a Board member needs to share the nature of the 

conflict is if she/he is seeking NOP input on whether recusal is appropriate or 

needed based on the nature of the conflict. 

2. If a Board member fails to disclose a COI that is later revealed (anyone), it may 

lead to the reconsideration of the vote (depending on the closeness of the vote), 

so it is vital that Board members are aware of conflicts and disclose them at the 

meeting(s). 

3. COI requirements do not extend to members of the public that come to the 

meeting and/or provide written views and opinions, unless they are expert 

witness(es) or consultant(s). As per public comment processes, all commenters 

are asked to state their affiliations at the start of their comments. 

4. NOP final decisions should be included in the minutes. 

Recommendation #11

On page 11 of the PPM, revise lines 8-12 to read,

Fully disclose any conflict of interest positions – Members having any commercial or 

immediate family interest that poses a potential or perceived conflict of interest must 

disclose that conflict to the subcommittee, Board, and NOP and abide by any decision 

of the NOP in dealing with the situation.

VI. Summary

NOSB members with diverse backgrounds are recruited to provide balance to the 

NOSB. While individual NOSB members represent the segments of the population from 

which they were selected, they also represent the greater good of the population as a 

whole. The revised COI and Ethics Policy are an attempt to address stakeholders, NOP, 

NOSB, and the public request for updating the Board‘s COI policy and provide for a 

greater level of transparency in the deliberation, discussion, and voting on matters 

pertaining to the Board authority for the benefit of the organic community. 

VII. Subcommittee Vote:

Moved: C. Reuben Walker Second: Jean Richardson

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

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National Organic Standards Board

Policy Development Subcommittee

Proposal: NOSB Meeting Public Comment Procedures

July 30, 2012

I. Introduction

Public input and transparency are central to the effective functioning of the 

NOSB. The proposed amendments to the Policy and Procedures Manual are 

intended to improve the ability of the NOSB to receive public comment.

II. Background

The six NOSB subcommittees meet using teleconference calls on a regular, 

typically twice a month basis, sharing information received from the public, 

actively seeking further information and data as they review an ever increasing 

range of complex substantive issues and develop recommendations. Twice a 

year the full NOSB physically meets together at a location within the U.S. These 

public meetings take place at different geographic locations in order to ensure 

that those who cannot travel long distances for reason of cost or time are more 

likely to have their voices heard, and assumes that more regional members of 

the public will attend in person, and also that regional differences in agriculture 

will thus be better understood by the Board as it develops recommendations to 

forward to the NOP.

For anyone involved in public policy it is well understood that input through public 

comment at open public meetings provides both challenges and opportunities. 

There is a delicate balance between letting everyone speak for as long as they 

want to, while allowing time for everyone present to be heard, and then time for 

their comments to be digested by those who listen and pose questions. In 

addition the public needs to feel confident that their views have been heard and 

taken into consideration before decisions are voted on. Well run and effective 

public meetings require clear rules and leadership. Over the last five years there 

has been an increasing interest by the public to attend the semi-annual meetings 

in order to provide public comment, and increasing mutual desire by the public 

and the Board to clarify and improve procedures for taking public comment. 

Thus, in October – November, 2011 the NOSB sought public input to clarify 

policy and procedures for receiving public comment specifically with reference to 

public meetings.

III. Relevant Areas of the Rule

The Organic Foods Production Act (OFPA) establishes the National Organic 

Standards Board at Section 2119 (7 U.S.C. 6518), “(a) The Secretary shall 

establish a National Organic Standards Board (in accordance with the Federal 

Advisory Committee Act (5 U.S.C. app. 2et seq.) [hereafter referred to as the 

“Board”] to assist in the development of standards for substances to be used in 

organic production and to advise the Secretary on any other aspects of the 

implementation of this title.”

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The Policy Procedures Manual (PPM), Section VI “Policy for Public Comment at 

NOSB Meetings” lays out the process and the time designations of public 

comment and further provides for, “Other suggestions that would be appreciated 

by NOSB members”.

IV. Discussion

It is clear that many members of the public are frustrated by the procedures for 

public comment at the national meetings and they seek clarification and a desire 

for greater confidence that the Board members have heard what they have to 

say, and have seriously considered their input. Comments also requested 

flexibility with public involvement.

Following are some of the issues raised:

Length of time to speak 

With an increased interest in public comment at meetings, there are typically 

many more speakers for the time allotted. While ten (10) minutes is too long to 

permit, it is clear that for many even five (5) minutes is a short time to speak 

given the complexity of issues and range of topics covered in one meeting. 

Requiring three (3) minutes as a time limit forces speakers to be concise and 

prioritize topics covered in verbal presentation. In addition speakers need to be 

reminded that they can also submit an expanded written version of their 

comments during the meeting. 

One commenter stated, “The length of time is not as important as that the 

designation of a time be regarded as a commitment.”

While it may be that speakers have travelled long distances, incurring expense 

and taking time to speak for only three minutes, it is also true that attending the 

meeting allows face-to-face exchange of data, information and policy concerns 

throughout the week.

Several organizations requested that the length of time be set at five (5) minutes 

and decreased to three (3) minutes if there were too many presenters for time 

period allotted, with flexibility being provided by the Chair.

Time allotted on agenda for public comment

There is widespread concern that there is not sufficient time on the week’s 

agenda for public comment. While this is probably a normal perception by the 

public for any national board, it is nonetheless an important issue to address. In 

past years, public comment extended into evening hours and the Board may 

wish to seriously consider returning to this option.

One commenter suggested extending total time allotted for public comment by 

one hour.

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Another stated, “We may reach a point when comments need to be prioritized, 

either on a first come first served, or randomized basis in order to ensure equity 

and diverse public input”.

Another comment suggested maintaining a waiting list for public comment.

Board questions to public speakers

There is a perception that Board members are not listening to the speakers 

because they do not ask many questions. And it is a perception that not all 

Board members are knowledgeable on the subject at hand because they do not 

ask questions. Thus it would seem counter-productive to consider “limiting Board 

questions” as a way to allow more public input, and none of the comments 

received suggested limiting Board questions.

Two organizations wanted it to be clear that Board question time was not 

considered part of the three (3) minutes of public comment, while being sure that 

Board members ask questions to clarify issues under consideration.

Board members should be encouraged by the Chair to ask questions that are 

relevant and required to assist the Board in reaching decisions on substantive 

issues, and to be active listeners. Further, there needs to be far greater public 

understanding of the inordinate number of hours every week that individual 

Board members in fact spend reviewing TRs, public input, committee meetings, 

e-mail exchanges and phone calls.

Public comment impact on Board decisions. 

There is a perception that the Board does not take the time to adequately review 

and apply public input prior to making their decision. In order to address this very 

real concern the Board should always have time to recess following a public 

comment period prior to making a public decision on an agenda item.

Use of proxy speakers

There is a mix of public perception on use of proxy speakers. One organization 

suggested continued use of proxy presentations, but stated that the information 

could also be achieved through written testimony. Three other comments 

suggested refined limitations to monitor implementation. 

There is a public perception that those who turn up and speak at the meeting will 

have a more direct impact on the immediate decisions of the Board. However 

there is the counter argument that the proxy is not in fact the originator of the 

input and cannot really answer any Board question, and such information could 

simply be provided in writing prior to the meeting. Eliminating proxy speakers will 

allow more time for those who are present in person.

Use of electronic participation in lieu of physical presence

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This is not an easy issue to address. On the one hand, attending the meeting is 

expensive and time consuming, limiting those who may attend, and there are a 

number of electronic means for communicating, such as via skype, or conference 

speaker phone, constant tweet inputs or other social networking tools, or by 

having a room full of people at a distant location with a TV type satellite 

connection. Any one of these or a combination could allow for increased input 

during the hours allotted to public comment. 

Indeed one might envisage a national meeting where committee members are 

scattered at various regional geographical locations nationwide using TV 

“classroom” connections, a teaching tool which university and other teachers 

have been using for years to teach at diverse locations simultaneously. All input 

would thus be essentially electronic. This would be an improvement over the 

faceless nature of the phone conference calls, but would be complex to set in 

place and would increase participation, which would in turn require more time 

allotment.

Conversely interested members of the public can submit public comment in 

writing, and public meetings rotate geographically around the US, allowing for 

greater regional participation over time. Further, there are already many people

who physically attend and not enough time to allow everyone to comment on 

everything that they would like to comment on. 

Based on comments reviewed and experience, the use of electronic 

communication is not recommended presently.

V. Recommendations 

Amend SECTION VI of the PPM, entitled NOSB Policy for Public Comment at 

NOSB Meetings, as follows:

NOSB Policy for Public Comment at NOSB Meetings: 

 

1. All persons wishing to comment at NOSB meetings during public comment 

periods must sign-up in advance per the instructions in the Federal Register 

Notice for the meeting. 

2. All presenters are encouraged to submit public comment in writing according 

to the Federal Register Notice. Advance submissions allow NOSB members the 

opportunity to read comments in advance electronically, and decreases the need 

for paper copies to be distributed during the meeting. 

3. Persons will be called upon to speak according to a posted schedule. However 

speakers should allow for some flexibility, and also note that persons called upon 

who are absent from the room could potentially miss their opportunity for public 

comment. 

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4. Time allotment for public comment per person will be four (4) minutes, with the 

options of reducing to a minimum of three (3) and extending to a maximum of five

(5) minutes at the discretion of NOP working closely with the NOSB Chair in 

advance of the meeting.

5. Persons must give their names and affiliations for the record at the beginning 

of their public comment. 

6. Proxy speakers are not permitted.

7. Public comment requests may be scheduled by major topics under 

consideration.

8. Individuals providing public comment will refrain from any personal attacks and 

from remarks that otherwise impugn the character of any individual. 

9. The NOSB will attempt to accommodate all persons requesting public 

comment time, however, persons requesting time after the closing date in the 

Meeting Notice, or during last minute sign-up at the meeting, will be placed on a 

waiting list and will be considered at the discretion of the NOP working closely 

with the NOSB Chair depending on availability of time.

10. Members of the public are asked to define clearly and succinctly the issues 

they wish to present before the Board. This will give NOSB members a 

comprehensible understanding of the speaker’s concerns. 

VI. Subcommittee Vote

Moved: Colehour Bondera Second: C. Rueben Walker

Yes 7 No 0 Abstain 0 Absent 1 Recuse 0 

220
National Organic Standards Board

Policy Development Subcommittee

Proposal: Public Communications

August 14, 2012

I. Introduction

A primary role of the National Organic Standards Board (NOSB) is to advise and 

counsel the Secretary, to represent the segments of the population from which they 

were selected, and to treat the business of the Board as fiduciaries for all members of 

the organic community and public at large (NOSB Policy and Procedures Manual, pp4-

8). 

The Federal Advisory Committee Act (FACA) Meeting Obligations to the Public (41 CFR 

102-3.140) suggests that, “Any member of the public is permitted to file a written 

statement with the advisory committee during meetings.”

In addition, the NOSB infrequently receives public communications outside of the 

designated public comment period. These communications include verbal and written 

information. 

II. Background

The Organic Foods Production Act (OFPA), enacted under Title 21 of the 1990 Farm 

Bill, serves to establish uniform national standards for the production and handling of 

foods labeled as “organic.” The Act authorized a new USDA National Organic Program 

(NOP) to set national standards for the production, handling, and processing of 

organically grown agricultural products. In addition, the Program oversees mandatory 

certification of organic production. The Act also established the National Organic 

Standards Board (NOSB), which advises the Secretary of Agriculture in setting the 

standards upon which the NOP is based. [Review at 

http://www.nal.usda.gov/afsic/pubs/ofp/ofp.shtml].

Sec.2119 [7 U.S.C. 6518] states that the NOSB consists of four individuals who own or 

operate an organic farming operation; two individuals who own or operate an organic 

handling operation, one individual who own or operates a retail establishment with 

significant trade in organic products; three individuals with expertise in areas of 

environmental protection and resource conservation; three individuals who represent 

public interests or consumer interest groups; one individual with expertise in the fields of 

toxicology, ecology or biochemistry, and one individual who is a certifying agent. 

The statutory mission in OFPA states:

“To assist in the development of standards for substances to be used in organic 

production and to advise the Secretary on any other aspects of the 

implementation of this title.” (OFPA, Sec 2119 (a))

As stated in the NOSB Policy and Procedures Manual (PPM, p5),the NOSB Mission 

Statement is: 

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“To provide effective and constructive advice, clarification and guidance to the 

Secretary of Agriculture concerning the National Organic Program (NOP), and 

the consensus of the organic community. 

 

In carrying out the mission, key activities of the Board include:

 

• “Assist in the development and maintenance of organic standards and 

regulations; 

• Review petitioned materials for inclusion on or deletion from the National List 

of Approved and Prohibited Substances (National List); Recommend changes 

to the National List; 

• Communicate with the organic community, including conducting public 

meetings, soliciting and taking public comments, provide timely information 

and education on the NOP, making reasonable use of a variety of 

communication channels.

• Communicate, support and coordinate with the NOP staff. “

The PPM (p8) states that NOSB members shall act impartially and not give 

preferential treatment to any organization or individual.

The PPM indicates (p6) that,

“To fulfill their responsibilities, Board members agree to adhere to three duties:

Duty of Care, Duty of Loyalty, and Duty of Obedience (p6). 

The PPM continues, 

“The Duty of Care calls upon a member to participate in the decisions of the 

Board and to be informed as to the data relevant to such decisions. In essence, 

the Duty of Care requires that a member:

 

Be reasonably informed—It is the duty of all Board members to seek and study 

the information needed to make a reasoned decision and/or recommendation on 

all business brought before the Board. The NOP will provide some of that 

information, but other information must be developed from independent sources.”

The National Organic Standards Board members study and evaluate all public 

communications, written and verbal communications, as a function of the NOSB 

role and duties, in order to benefit the organic community. In so doing, National 

Organic Standards Board members are able to provide effective and constructive 

advice, clarification and guidance to the Secretary of Agriculture and the NOP. 

NOP said in the National Organic Program Newsletter, December 11, 2011:

The members of the National Organic Standards Board (NOSB) and the National 

Organic Program (NOP) often receive letters and requests from people 

interested in our upcoming regulatory activities and meetings. In this note, we 

summarize the best way to direct your letters and requests.

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As a Federal Advisory Committee, the NOSB has a well-defined scope of activity. 

If you have opinions and requests to share with the Board, please use the public 

comment period that is open before each NOSB meeting to submit your 

thoughts. Or, submit a formal National List petition for consideration using the 

guidelines provided in the link below.

The NOP is the best place to send your letters outside the NOSB public 

comment and petition process. In addition to formal public comment periods on 

specific regulatory actions, we are always open to comments on a variety of 

topics related to organic agriculture. While we cannot guarantee that every letter 

will receive a direct response, your letters do get an audience and help us 

identify and prioritize needs. We look forward to hearing from you!

This explanation by NOP describes the current official means of communication 

outlined in the PPM, which does not prohibit other forms of communication 

between the public and NOSB members. The NOP statement, however, 

suggests a need to clarify the ability of the public to provide public comments

outside of Board meetings and the public comment periods to inform the Board’s 

and Program’s work.

III. Summary

The National Organic Standards Board through it Policy and Procedures Manual 

establishes procedures for its activities. The Manual “is designed to assist the Board in 

its responsibilities” (PPM, p4) and establish procedures for carrying out its 

responsibilities in accordance with its advisory mission.

Because of the opportunities that the Board has to hear from the organic community in 

the course of fulfilling its mission, it has both an opportunity and responsibility to bring to 

the Secretary of Agriculture information that it believes may impact on the 

implementation of OFPA. This communication may, by necessity, extend to organic 

standards and practices as well as related issues that may affect those standards and 

practices. Therefore, based on the communications and input it receives from the 

public. the National Organic Standards Board may provide effective and constructive 

advice, clarification, and written information, as it deems necessary, directly to the 

Secretary of Agriculture after each of its Board meetings. 

Additionally, and as a part of its responsibility to communicate with the organic 

community pertaining to the implementation of OFPA, the Board must receive and 

review information from the NOP and other sources during its deliberations. As a 

stakeholder Board, the input from the organic community is valuable in the deliberations 

of the Board and the community decision making process. The procedures of the Board 

should facilitate public communication to inform these deliberations.

IV. Recommendations

PPM, Section VI, Miscellaneous Policies, page 26 is amended by adding a new 

subcategory (in italics):

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NOSB Policy on Its Advisory Role and Communication with the Secretary of 

Agriculture

Based on the communications and input it receives from the public. the National 

Organic Standards Board may provide effective and constructive advice, clarification, 

and written information, as it deems necessary, directly to the Secretary of Agriculture 

after each of its Board meetings. This information is intended to facilitate public 

communication with the Secretary on critical issues that may emerge that it believes are 

important to the implementation and integrity of the organic standards and practices 

under the Organic Foods Production Act.

PPM, Section VI, Miscellaneous Policies (page 27), is amended by adding a new 

subcategory (in italics).

NOSB Policy for Public Communication Between NOSB Meetings.

The NOSB seeks public communication outside of Board meetings and public comment 

periods to inform Board and Program work. 

PPM Section II (page 13) Role of the Executive Director is amended to include the 

following language (in italics):

Identify, implement, administer and maintain a year-round mechanism by which public 

feedback can be received, posted and archived for viewing by the NOP, the NOSB, and 

the public itself.

V. Subcommittee Vote

Moved: Jennifer Taylor Second: Colehour Bondera

Yes 8 No 0 Abstain 0 Absent 0 Recuse 0 

224
National Organic Standards Board

Compliance, Accreditation and Certification Subcommittee

Discussion Document: 

Calculating Percentage Organic in Multi-ingredient Products

August 14, 2012

I. INTRODUCTION:

 

The purpose of this document is to review how accredited certifying agents (ACA’s) and 

handlers are determining percentage organic ingredients in multi-ingredient products 

and develop clear policy that can assist the NOP in development of guidance for 

certifiers and handlers.

Consumers expect that labels on multi-ingredient products sold as “100% organic” or 

“organic” or “made with organic” reflect an accurate determination of percentage organic 

ingredients, and that all certifiers have uniformly calculated such percentages.

The integrity of USDA organic products in the USA and throughout the world depends 

on assurances of consistency and uniformity in interpretation and application of the law 

and regulation, especially when calculating percentage organic ingredients.

II. BACKGROUND:

The NOP regulation at§ 205.302(c), under “Calculating the percentage of organically 

produced ingredients” states: 

“The percentage must be determined by the handler who affixes the label on the 

consumer package and verified by the certifying agent of the handler. The handler 

may use information provided by the certified operation in determining the 

percentage”.

Thus, when an ingredient has been certified to the “organic” category, the supplier of 

that ingredient must provide information to the handler making the finished product 

regarding the actual percentage of organic content of that ingredient.

Over the years this has resulted in a wide variety of mechanisms for determining 

percentage of organic ingredients, and a wide variety of ways of establishing systems 

which allow verification by auditors and inspectors. 

For example, if the supplier does not provide positive information, verified by the 

certifier, that the organic ingredient contains more than 95% organic content, then many 

certifiers will only allow that ingredient to be calculated at 95% organic content, but not 

all certifiers do this.

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Since the Rule was first put in place there have been an increasing number of certifying 

agents who certify multi-ingredient products and, with no clear guidance to the contrary, 

a lack of uniformity in procedures has developed. For example some certifiers may 

permit handlers to include 100% of the weight/volume of certified ingredients as organic, 

even if the ingredient is a formulated product and includes other permitted substances 

and may be in fact be anywhere from 95-100% organic. For example, chocolate chips 

may be certified organic, and contain 96 % organic ingredients, plus 4% permitted 

substances on §205.605or §205.606. A cookie manufacturer may be considering that 

the entire weight of the chips counts as organic in the final cookie product. 

Further, some handlers, certifiers, inspectors may not be accurately examining the 

water and salt content for exclusion from the percentage calculation. 

In addition there is a wide array of mechanisms in place amongst handlers as to how 

processing aids as opposed to additives are recorded or, if necessary calculated as part 

of the ingredient list.

Standard practice is to calculate organic ingredients as a percentage of all ingredients,

although the relevant area of the regulation, § 205.302(a)(1-3), still states the 

calculation should be as a percentage of finished product. 

In October 2001 the NOSB recommended to change to the regulations at § 205.302(a) 

to replace the phrase “finished product” with “of all ingredients”. The rationale was: 

“ Most products lose weight during processing. Dividing the total weight of all 

combined organic ingredients by the weight of the finished products could easily 

show that a product contains over 100% organic ingredients. Current practice is 

to divide the total weight of all combined organic ingredients by the total weight of 

all ingredients (excluding salt and water). This calculation establishes the total 

percentage of organic ingredients. The Rule should be changed to correctly 

calculate the percentage of organic ingredients.” 

This regulation change has not yet taken place.

Sub-ingredients are often added to multi-ingredient products, such as spice or flavor or 

sauce mixes. Such sub-ingredients may be entirely or partially organic in ingredient 

make up, and the producer of such sub-ingredient mix may provide a specification sheet 

listing ingredients and their organic percentages. In other instances no details are 

provided on sub-ingredients.

When the percentage of organic ingredients as a percentage of all ingredients, is 

calculated to be close to 95% or close to 70% then the issue of correct labeling of that 

product becomes difficult for the handler and those who must approve or verify.

III. RELEVANT AREAS OF THE RULE:

 

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NOP Regulation and Policy statements:

§ 205.302 Calculating the percentage of organically produced ingredients.

(a) The percentage of all organically produced ingredients in an agricultural 

product sold, labeled, or represented as “100 percent organic,” “organic,” or 

“made with organic (specified ingredients or food group(s)),” or that include 

organic ingredients must be calculated by:

(1) Dividing the total net weight (excluding water and salt) of combined 

organic ingredients at formulation by the total weight (excluding water and 

salt) of the finished product.

(2) Dividing the fluid volume of all organic ingredients (excluding water and 

salt) by the fluid volume of the finished product (excluding water and salt) 

if the product and ingredients are liquid. If the liquid product is identified on 

the principal display panel or information panel as being reconstituted from 

concentrates, the calculation should be made on the basis of singlestrength concentrations of the ingredients and finished product.

(3) For products containing organically produced ingredients in both solid 

and liquid form, dividing the combined weight of the solid ingredients and 

the weight of the liquid ingredients (excluding water and salt) by the total 

weight (excluding water and salt) of the finished product.

(b) The percentage of all organically produced ingredients in an agricultural 

product must be rounded down to the nearest whole number.

(c) The percentage must be determined by the handler who affixes the label on 

the consumer package and verified by the certifying agent of the handler. The 

handler may use information provided by the certified operation in determining 

the percentage.

IV. DISCUSSION: 

1. Language change: It is assumed that all handlers are calculating percentage organic 

based on percent of all ingredients, not finished products, and yet the Rule does not 

state this. 

The CACS is considering a recommendation for a Rule change at the spring 2013 

meeting to replace at 205.302 (a), 1, 2, and 3, the language “finished product” with the 

phrase “of all ingredients”. Prior to this rulemaking action, the CACS is seeking 

information from ACA’s on current practices to bring efficient uniformity to the process, 

especially when ingredients cross certifier lines. 

2. Typically a processor of a multi-ingredient product applies to an NOP accredited 

agent and receives the annual application forms and instructions of that specific 

certifier. Each certifier has their own set of forms, many of which are fillable documents 

such as a form for calculating organic percentage, several examples of which have 

been reviewed by the CACS. Such product formulation sheets list water and salt and 

processing aids which are not included in the self-calculation.

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There is also usually a Product Profile form for every multi-ingredient product, listing all 

ingredients, name of supplier, certifier of each ingredient, and percentage of each 

ingredient relative to the total of all ingredients, EXCLUDING water and salt. Water may 

be in included in the calculation when it is specified as part of an FDA standard of 

identity, (includes single strength juices, does not include soy milk or juices for which 

there is no standard of identity). FDA standards of identity are found at 21 CFR 131-

169. 

With the growth of processed organic foods, it can be very difficult for handlers, 

certifiers and inspectors to consistently derive the same calculations with varied format 

specification sheets and calculation forms.

In order to obtain uniformity in organic claims for products, should the NOSB 

recommend standardized forms and/or the use of self-calculating tables for determining 

organic percentage, and specification sheets for all sub-ingredients?

3. In calculating the percentage organic of sub-ingredient mix either the handler 

assumes 95% organic content, or obtains additional verification of the actual organic 

content from the supplier to justify a higher claim. If no “Specification Sheets” (or 

equivalent information) on the sub-ingredients are available, the certifier and inspector 

has to assume the lowest denominator based on sub-ingredient list reviewed, so it 

defaults to 95% or 70%.

If sub-ingredients are included without a specification sheet and accompanying 

calculation, should ingredients be calculated as 70%, 95% or 100% based on stated 

labeling category? 

4. Processing aids. We understand the variability among certifiers on how processing 

aids affect the 100% label claim. If a product is not allowed the 100% claim, does it fall 

all the way to 95%? This could automatically keep numerous products out of organic 

status and fall to “made with” status.

5. Salt. Does the ACA or handler consider other salts, such as potassium chloride as 

well as sodium chloride in determining calculation? 

V. REQUEST FROM CAC Subcommittee: 

The CACS is seeking input in developing upcoming recommendations if necessary. 

Please give us your input on these questions and other pertinent information, as you 

deem necessary.

1. What difficulties do you encounter when verifying percentage calculations for 

multi-ingredient products? Do supplier forms meet necessary expectations?

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2. Is calculating the percentage organic made more complex when multiple 

certifier forms are being used to make calculations for multi ingredient 

products with sub-ingredients ?

3. Should all ACA’s use a uniform calculation tool to verify percentage 

calculations?

4. Do all ACA’s provide calculation tools to reviewers/inspectors? Do inspectors 

have their own tools? Are there an adequate number of qualified inspectors 

available perform this work?

5. How does use of processing aids affect percentage organic calculations? For 

example in the absence of other technical specification does the product 

default to the 95% category for the purpose of the calculation? 

6. Would guidance from the NOP bring clarity and uniformity to the process? 

What features and characteristics should be incorporated into the policy?

7. Do we have in place adequate mechanisms to ensure that all agricultural 

products which have received no post harvest treatment can be verified to the 

100% category as raw ingredients for calculating percentage organic in multiingredient products? Explain process used in calculation.

The CAC Subcommittee would appreciate receiving answers to the questions posed 

above as well as other suggestions on how best to ensure consistency and uniformity in 

determining percentage organic in multi-ingredient products.

Sub Committee Vote:

Moved: Jean Richardson Second: Calvin Walker

Yes- 8 No- 0 Abstain- 0 Recusal- 0 Absent- 0 

229
National Organic Standards Board

Compliance, Accreditation and Certification

Discussion Document: 

Implementation of Biodiversity Conservation in Organic Agriculture Systems

July 23, 2012

I. INTRODUCTION:

The purpose of this Discussion Document is to review progress in implementing 

the Board’s recommendations on biodiversity conservation, made on May 6, 

2009, and to identify other aspects of implementation of the NOP biodiversity 

standards that may require attention.

Another purpose of this document is to draw attention to the value of biodiversity 

to organic production systems and the importance of implementing conservation 

practices. 

The value of biodiversity for healthy agriculture and for society at large is 

recognized in the NOP rule in several places. In response, the NOSB issued 

Guidance statements in 2004, 2005 and as indicated above, again in 2009.

It is worth stating here what is encompassed in the term “biodiversity.” Biological 

diversity is the diversity of life existing at three levels: genetic, species and 

ecosystem diversity. Therefore, the concept of biological diversity (biodiversity) 

includes all of the following:

• Variety in all forms of life, from bacteria and fungi to grasses, ferns, trees, 

insects, and mammals;

• The diversity found at all levels of organization, from genetic differences 

between individuals and populations (groups of related individuals) to the 

types of natural communities (groups of interacting species) found in a 

particular area; and

• The full range of natural processes upon which life depends, such as 

nutrient cycling, carbon and nitrogen fixation, predation, symbiosis and 

natural succession.

II. BACKGROUND:

The Principles of Organic Farming, as adopted by the NOSB on Oct 12, 2001, 

expresses the values and goals that link organic farming with protection of 

biodiversity. Many organic production systems recognize the value of biodiversity 

to a farm’s long term sustainability as well as an understanding that agriculture 

systems function within, and interact with, the larger ecosystem. 

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A number of individuals and organizations interested in biodiversity conservation 

in organic agriculture have worked to advance these ideas. In particular, the Wild 

Farm Alliance (WFA) has published guides about biodiversity conservation for 

farmers and for certifiers, has produced a document on Biodiversity Compliance 

Assessment, and has contributed many valuable suggestions to the NOSB and 

NOP on ways to advance biodiversity conservation. The International Organic 

Inspectors Association (IOIA) has also played a very important role in filling the 

need for trainings on biodiversity for inspectors using the organization’s own 

materials as well as the WFA guides. ATTRA has developed templates for 

Organic System Plans that include a section on biodiversity. This provides a 

mechanism for operators to document the practices they use to support 

biodiversity conservation and to convey that information to their certification 

body.

On April 29, 2004, the NOSB adopted a guidance document “Compatibility with a 

System of Sustainable Agriculture and Consistency with Organic Farming and 

Handling,” which included the following factor to be considered in the process of 

materials review: “L) Does use of the substance have a positive impact on 

biodiversity?” 

The next year (August 16, 2005) the NOSB adopted an amendment to the OSP 

template which added a criterion on biodiversity to the form.

The discussion of biodiversity at the May 2008 NOSB meeting resulted in a plan 

for joint review of implementation of biodiversity standards by the CAC and Crops 

Committee and, as necessary, for the Joint Committee to prepare further 

guidance for Board consideration. The analysis by the Joint Committee 

determined that the biodiversity conservation requirements were not being 

implemented fully or consistently.

The Joint Committee produced a discussion paper in 2009, titled “Implementation 

of Biodiversity Conservation in Organic Agriculture Systems.” The document 

received more than 60 written and oral comments—most strongly supported the 

need to improve and increase implementation of biodiversity conservation in 

organic agriculture. Many commentors expressed a sense of urgency for timely 

action.

Based on the findings of the Joint Committee, on May 6, 2009, NOSB sent a 

recommendation to NOP that addressed improvements in the implementation of 

biodiversity standards through two different vehicles:

1) Material Review by the NOSB—Add biodiversity considerations to the 

check list used for the review of materials; and

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2) Development and implementation of the Organic System Plan—this

included specific recommendations for actions to be taken by a) certified 

grower/producer, b) inspectors, c) certifiers, and d) NOP.

III. RELEVANT AREAS IN THE RULE:

1. The Preamble

The Preamble to the Rule (Federal Register/Vol. 65, 246/Thursday, 

December 21, 2000/pg. 80563) (4) CONSERVATION of BIODIVERSITY 

states in part: 

“We agree with commenters and have amended the definition of 

organic production to require that a producer must conserve 

biodiversity on his or her operation. The use of “conserve” establishes 

that the producer must initiate practices to support biodiversity and 

avoid, to the extent practicable any activities that would diminish it. 

Compliance with the requirement to conserve biodiversity requires that 

a producer incorporate practices in his or her organic system plans that 

are beneficial to biodiversity on his or her operation. 

2. NOP Rule passages relevant to Biodiversity Conservation are as 

follows: §205.2 Terms defined:

Crop Rotation. Perennial cropping systems employ means such as alley 

cropping, intercropping and hedgerows to introduce biological diversity in lieu 

of crop rotation. 

Natural Resources of the Operation. The physical, hydrological, and 

biological features of a production operation, including soil, water, wetlands, 

woodlands, and wildlife. 

Organic Production. A production system that is managed in accordance 

with the Act and regulations in this part to respond to site-specific conditions 

by integrating cultural, biological, and mechanical practices that foster cycling 

of resources, promote ecological balance, and conserve biodiversity. 

Organic System Plan. A plan of management of an organic production or 

handling operation that has............ 

Pasture. Land used for livestock grazing that is managed to provide feed 

value and maintain or improve soil, water, and vegetative resources. 

Soil and Water Quality. Observable indicators of the physical, chemical, or 

biological condition of soil and water, including the presence of 

environmental contaminants. 

§205.200 General. Production practices....must maintain or improve the 

natural resources of the operation including soil and water quality. 

3. Other sections of the Rule related to Biodiversity

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• §205.203 Soil fertility

• §205.205 Crop rotation 

• §205.206 Crop pest, weed, and disease management practice 

• §205.707 Wild-crop harvesting 

• §205.237 Livestock feed 

• §205.238 Livestock health care 

• §205.239 Livestock living conditions 

IV. PROGRESS and DISCUSSION:

This section of this Discussion Document presents progress reports and 

discussions that are based on an analysis of the points in the NOSB’s 2009 

Recommendation, “Implementation of Biodiversity Conservation in Organic 

Agriculture Systems”:

1) The Materials Review Process:

Recommendation from 2009: Add biodiversity considerations to the checklist 

used for review of materials as shown below for specific categories and lines:

Category 1. Adverse impacts on humans and the environment?

Line 3. Is the substance harmful to the environment and BIODIVERSITY?

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

Line 2. Is the substance consistent with organic farming and handling and 

BIODIVERSITY.

Progress Report & Discussion Points: These changes in the Materials 

Review Checklist were made and approved for addition to the PPM on 

November 5, 2009.

To assist in material review: Technical reports are frequently requested 

by the NOSB. Evaluation question 8 now directs the TR contractor to” 

describe any effects of the petitioned substance on biological and or 

chemical interactions in the agro-ecosystem, including physiological 

effects on soil organisms (including the salt index and solubility of the 

soil), crops, and livestock (7 USC 6518 (m)(5).”The following additional 

requirement to question 8 is being added:” In addition the response 

should describe the potential or actual impacts of the substances upon 

endangered species, populations, viability or reproduction of non-target 

organisms and the potential for measurable reductions in genetic, 

species of ecosystem biodiversity, if possible.”

With regard to materials review, the following question comes to mind:

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QUESTION: The check list question now asks, “Is the substance harmful to 

biodiversity?” The NOSB Guidance Document adopted 4/29/2004 asks

another question, “Does use of the substance have a positive impact on 

biodiversity?” Although both of these questions address biodiversity, they do 

so from different reference points, creating harm vs. having a positive impact. 

Should the questions on used on the checklist for materials review focus 

on asking whether a material has a positive impact on biodiversity, in 

addition to the question about harm? 

2) Development and Implementation of the Organic System Plan:

NOSB recommended that the following actions be taken with regard to the 

OSP:

a) Certified Grower/ Producer - Recommendation from 2009:

Producers shall incorporate biodiversity conservation into their OSPs. The 

questions on ATTRA’s OSP templates (Pages 7&8 on the farm template) or 

guidance tools such as those developed by WFA, provide detailed information 

and direction. The producer shall be ever vigilant to biodiversity problems and 

conservation opportunities. Conversion of native habitat to crop production 

has consequences to biodiversity that must be considered and the producer 

should discuss such planned conversion with his or her certifier before action 

is taken. 

Progress Report: In the spring of 2011, the NOP published an updated 

version of the natural resources section of the OSP, with assistance from 

ATTRA.

On May 12, 2012, after extensive work, the Wild Farm Alliance and 39 

signatories, submitted a Biodiversity Conservation Document to the NOP for 

inclusion into the National Organic Program Handbook. The Guidance is 

intended to assist producers and Certifiers understand how to comply with 

requirements related to the conservation of biodiversity in crops, livestock and 

handling operations. 

The NOP is reviewing the document submitted by WFA for possible use as 

guidance document.

The NOSB 2009 guidance document raises the issue of conversion of native 

lands to organic production. In the Introduction it states “a particularly 

controversial issue is how to deal with conversion of native forests or 

grasslands for organic crop cultivation”. The document then under 2 (a) 

Certifier Grower/ Producer states that “conversion of native habitat to crop 

production has consequences to biodiversity that must be considered and the 

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producer should discuss such planned conversion with his or her Certifier 

before action is taken”.

The WFA proposed Guidance presented to the NOP addresses conversion of 

“high conservation value land” as shown in this italicized text: 

If an operation is considering converting high conservation value land, the 

benefits of more farmable acreage is weighed against the loss of habitat 

functions that may provide pollinator and predatory insect food and cover, 

and water quality protection to the farm. If the decision to proceed in 

converting the land is made, the following steps are taken depending on 

certification status:

i) When the land is certified organic:

(a) The operator submits for approval to the ACA a revision to the 

Organic System Plan (OSP) describing the proposed actions prior 

to implementing any conversion. This eliminates the possibility of 

loss of certification. The request includes photos and written 

evidence from a conservation organization such as USDA NRCS 

using their two pages Environmental Evaluation Worksheet CPA 52 

which documents any adverse effects that will occur to threatened, 

endangered, and rare species, or causes soil erosion, degradation 

of water quality and other biological and environmental effects. If 

any adverse affects are noted, mitigation measures are 

implemented elsewhere on the property or in the region to 

compensate for loss to biodiversity. An agreement between the 

operator and the ACA will be made where the ACA monitors the 

mitigation measures until success is achieved, or more mitigation 

efforts are required.

ii) When none of the land to be converted is certified organic:

(a) The operator is treated as above, if the operator first creates an 

OSP describing the proposed actions prior to conversion and 

seeks approval by the ACA.

(b) If the operator does not first seek approval by the ACA, she/he 

submits photos and written evidence of any past adverse effects 

caused by the conversion, as mentioned above. An agreement 

between the operator and the ACA will be made where the ACA 

possibly requires mitigation measures that are monitored until 

success is achieved or more mitigation efforts are required.

The NOSB is interested in the community’s response to this recommended 

guidance and other thoughts on this important topic. 

The primary tool for ensuring biodiversity conservation compliance is 

education and the Guidance could be an important part of that.

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Recent efforts by NCRS and NCAT projects are assisting farmers build a 

bridge with NOP resulting in improved conservation compliance. These efforts 

must continue and be strengthened.

b) Inspectors - Recommendation from 2009:

Inspectors shall receive training in biological diversity conservation such as is 

currently given by IOIA and include methods for verification of NOP 

biodiversity standards in all inspections of organic farms using appropriate 

checklists and other tools. Other issues not explored by biodiversity 

verification methods, but that should be evaluated by inspectors include: 

• Sustainable practices for incorporating new land into agriculture 

• Practices which enhance soil biodiversity 

Progress Report: IOIA now emphasizes biodiversity conservation in its 

inspector training and has developed webinar training with a biodiversity 

focus.

Comments from individual inspectors support the need more training. 

Education and training about biodiversity is needed at all levels of the organic 

food production process before the full capacity of improved biodiversity will 

be realized. Stated by one inspector “from the farmer to the shopper, the 

value of improved biodiversity must be better appreciated and implemented. 

The opportunities are huge. We’ve only begun the process.”

c) Certifiers - Recommendation from 2009:

Certifiers shall adopt an OSP and other certification documents that address 

the NOP biodiversity requirements. Certifiers may devise a format and 

content for these documents that is suitable to their own certification system. 

Certifiers shall require all production operations to address biodiversity 

conservation in their OSPs. Conversion of native habitat to crop production 

has important consequences to biodiversity and normally should be 

discouraged. 

Certifiers shall document the degree to which producers are addressing 

biodiversity when performing inspections and when making certification 

decision. Only severe violations would lead to suspension or revocation of a 

producer’s certification, other violations would be cited as minor noncompliances by the certifiers and corrected by the operator within a specified 

timeframe.

Progress Report: Information received indicates that more certifiers are 

addressing biodiversity requirements in a systematic way. However, it 

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appears that to achieve consistently full implementation of requirements, 

more guidance from the NOP is needed.

An issue that has been reported is that some certifiers do not want inspectors 

to address §205.200 subject matter in inspection of handling operations. This 

needs to be clarified.

A suggestion for addressing “new land” issue is made in the above statement 

on Certified Grower/Producer.

The CACS would like to hear from Certifiers on what they have done since 

the 2009 recommendations were issued: what works and what doesn’t. 

Also CACS what like to learn from Certifiers ( and Inspectors) what 

biodiversity conservation issues they have encountered with handling 

operations.

d) National Organic Program - Recommendation from 2009:

The NOP shall emphasize biodiversity in its training of NOP-accredited 

certification bodies. Trainings shall include such topics as indicators of 

compliance with biodiversity standards, differentiating major and minor noncompliances for violations of biodiversity standards, evaluating corrective 

actions taken to correct minor violations. The focus should be on education, 

teaching practices and the benefits of conservation. The NOP shall also 

revise the checklist used to audit certifiers so that it includes questions about 

NOP’s biodiversity standards in every audit.

Progress Report: The NOP is addressing the 2009 recommendations and 

has started to make changes in the audit check list. 

Wild Farm Alliance has provided the NOP suggestions for changes in the 

NOP’s audit checklist to address biodiversity standards in every audit of 

ACAs. 

V. REQUEST FROM THE CAC Subcommittee:

The CAC Subcommittee would appreciate receiving answers to the questions 

posed above as well as other suggestions on methods for strengthening 

biodiversity conservation within organic production systems for all scopes of 

accreditation, particularly handling.

Sub Committee Vote:

Moved: Richardson Second: Stone

Yes- 8 No- 0 Abstain- 0 Recusal- 0 Absent- 0 

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