National Organic Standards Board | October 2019| Proposals & Discussion Documents

TOC 1 

National Organic Standards Board Meeting

Doubletree Hotel & Suites Pittsburgh City Center | One Bigelow Square 

Pittsburgh, Pennsylvania | Pennsylvania Ballroom

October 23-25, 2019

Title Page

Handling Subcommittee (HS) | Asa Bradman, Chairperson 

2021 Handling Sunset Reviews: §205.605 & §205.606 1

Crops Subcommittee (CS) | Steve Ela, Chairperson 

67

73

77

Proposal: Fatty Alcohol (C6, C8, C10, C12 Naturally Derived) - petitioned

Proposal: Potassium hypochlorite - petitioned

2021 Crops Sunset Reviews: §205.601 & §205.602

Discussion Document: Paper (Plant pots and other crop production aids) - petitioned 101

Materials Subcommittee (MS) | Emily Oakley, Chairperson

Proposal: Excluded Methods: Induced mutagenesis and embryo transfer in livestock 109

Proposal: Genetic Integrity Transparency of Seed Grown on Organic Land 115

Proposal: NOSB Research Priorities 2019 121

Discussion Document: Marine materials in organic crop production 131

Policy Development Subcommittee (PDS) | Rick Greenwood, Chairperson

Proposal: Updates to the policy & procedure manual (PPM) 149

Livestock Subcommittee (LS) | Sue Baird, Chairperson

Proposal: Use of excluded method vaccines in organic livestock production 191

2021 Livestock Sunset Reviews: §205.603 201

Discussion Document: Fenbendazole - petitioned 227

PLEASE NOTE: 

Discussion documents, proposals, reports and/or other documents prepared by the National Organic Standards Board, including its 

subcommittees and task forces, represent the views of the National Organic Standards Board and do not necessarily represent the 

views and policies of the Department of Agriculture. Please see the NOP website for official NOP policy, regulations, guidance and 

instructions. 
TOC 2
Sunset 2021

Meeting 2 - Review 

Handling Substances §§205.605(a), 205.605(b), 205.606

October 2019

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the National 

List of Allowed and Prohibited Substances (National List) that are coming up for sunset review by the 

National Organic Standard Board (NOSB). The following list announces substances that are on the National 

List for use in organic handling that must be reviewed by the NOSB and renewed by the USDA before their 

sunset dates in 2021. This list provides the substance’s current status on the National List, use description, 

references to past technical reports, past NOSB actions, and regulatory history, as applicable. 

Request for Comments

Written public comments will be accepted through October 3, 2019 via www.regulations.gov. Comments 

received after that date may not be reviewed by the NOSB before the October meeting. 

NOSB October 2019 proposals and discussion documents Page 1 of 230
Sunset 2021

Meeting 2 - Review 

Handling Substances §§205.605(a), 205.605(b), 205.606

October 2019

Note: With the exception of activated charcoal, L-malic acid, microorganisms, peracetic acid/peroxyacetic 

acid, and sodium acid pyrophosphate, the materials included in this list are undergoing early sunset review 

as part of the November 18, 2016, NOSB recommendation on efficient workload re-organization. 

Reference: 7 CFR 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)).’’

§205.605(a) Nonsynthetics allowed:

Acid, Citric

Acid, Lactic

Calcium chloride

Dairy cultures

Enzymes

L-Malic acid

Magnesium sulfate

Microorganisms

Perlite

Potassium iodide

Yeast

§205.605(b) Synthetics allowed:

Activated charcoal

Alginic acid

Ascorbic acid

Calcium citrate

Ferrous sulfate

Hydrogen peroxide

Nutrient vitamins and minerals

Peracetic acid

Potassium citrate

Potassium phosphate

Sodium acid pyrophosphate

Sodium citrate

Tocopherols

Reference: 7 CFR 205.606 Nonorganically produced agricultural products allowed as ingredients in or on 

processed products labeled as “organic.”

Celery powder

Fish oil

Gelatin

Orange pulp, dried

Seaweed, Pacific kombu

Wakame seaweed (Undaria pinnatifida)

Links to additional references and supporting materials for each substance can be found on the NOP 

website: http://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned

NOSB October 2019 proposals and discussion documents Page 2 of 230
Acids – Citric

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: Acids (Citric – produced by microbial fermentation of 

carbohydrate substances; and Lactic).

Technical Report: 1995 TAP - Citric; 2015 TR - Citric; 1995 TAP - Lactic; 2015 TR - Lactic

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review:

Use:

Citric acid is widely used in food processing. It is used as an ingredient, acidulant, pH control agent, 

flavoring, and as a sequestrant. It is used as a dispersant in flavor or color additives. It is also an ingredient 

in dietary supplements and a nutrient, sequestrant, buffer, antioxidant, firming agent, acidity regulator (in 

jams and jellies, soft drinks and wines), raising agent, and emulsifying salt for many other products. It is also 

used to improve baking properties of flours, and as a stabilizer, and to inhibit color and flavor deterioration 

in fruits. Roughly 75% of all citric acid commercially produced is used by the food industry with the 

remainder used in cleaning agents, or in the cosmetics and pharmaceutical industries. 

Manufacture:

First isolated from lemons, it was extracted from lemons and limes until 1919 when production shifted to 

fermentation (a biological process by which sugars are metabolized to acids, gases, and/or alcohol). Today, 

the mold Aspergillus niger is cultured with low pH values and high levels of sugars and mineral salts to 

economically produce high yields through fermentation. Various chemical synthesis of citric acid appeared 

but none have reached the economics derived from the fermentation process. The fermentation process 

has been refined over the years to produce high levels of citric acid instead of high levels of the by-product 

oxalic acid. Some public commenters expressed a concern that the fermentation process involves the use of 

synthetic chemical reactions that were not considered in the original 1995 classification. 

International Acceptance:

Citric acid is an allowed ingredient in all international organic standards reviewed in the 2015 TR. The only 

noted annotation is that Japan Agriculture Standards allow citric acid but only as a pH adjuster for 

processed fruits and processed vegetables.

Environmental Issues:

Although it is a weak acid, exposure to pure citric acid may cause coughing, shortness of breath, and skin 

irritation. The fermentation process does produce by-products including oxalic acid. Citric acid will degrade 

to produce non-toxic and non-persistent environmental products. The last time EPA evaluated citric acid 

was 1992 at which time they found it posed no environmental risk. 

Discussion: 

Citric acid has GRAS status (Generally Recognized as Safe) by the FDA. Citric acid has many uses in food 

production. It has a history of safe use in organic foods dating back to 1995. Natural citric acid may be 

NOSB October 2019 proposals and discussion documents Page 3 of 230
isolated from organically grown fruit but has not been commercially available in the quantities that would 

be required to service the organic sector. 

According to 2019 spring public comment citric acid is used to control PH, as an acidulant, a buffer, in gel 

formation, to stabilize colors, and as an ingredient in dietary supplements. In the organic produce sector it’s 

widely used in the formulation of disinfectants and sanitizers allowed for use in direct contract with organic 

food without the need for a rinse, a practice essential for complying with FSMA requirements. It’s also used 

for controlling pH in wash water used for the post-harvest handling of fresh fruits and vegetables. 

Additionally, neutralizing the PH of wash water thereby reduces the amount of chlorine that needs to be 

added to the water (in order to achieve the desired levels of “free chlorine”). Four certifiers submitted 

public comment indicating a total of 240 Organic Systems Plans which include citric acid. 

Two commenters wrote that citric acid should be classified as synthetic unless it is possible to define nonsynthetic citric acid by annotation. The TR found citric acid to be non-synthetic since it is processed via 

fermentation. 

No new information was brought forward in terms of harm to human health or the environment. 

Questions:

1. Are there any commercially available sources of citric acid derived from organically grown crops?

Subcommittee Vote:

Motion to remove citric acid based on the following criteria in the Organic Foods Production Act (OFPA) 

and/or 7 CFR 205.605(a) if applicable: NA

Motion by: Lisa de Lima

Seconded by: Scott Rice 

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

Acids – Lactic

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: Acids (Citric – produced by microbial fermentation of 

carbohydrate substances; and Lactic).

Technical Report: 1995 TAP - Citric; 2015 TR - Citric; 1995 TAP – Lactic; 2015 TR - Lactic

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use:

Lactic acid is widely used in almost every segment of the food industry, where it carries out a wide range of 

functions. The major use of lactic acid is in food and food-related applications, which in the U.S. accounts 

for approximately 85% of the demand. It is found naturally in milk, meat, and beer but is normally 

associated with sour milk. Lactic acid controls the growth of bacteria including listeria (NOSB Fall Meeting 

NOSB October 2019 proposals and discussion documents Page 4 of 230
Transcript 2015 pp. 263). It has been in use as an acidulant and pH regulator for many years. Lactic acid 

appears on the National List, 7 CFR Part 205.605(a), as a non-synthetic material with no restrictions on use.

Common uses include, but not limited to: 

1. In sugar confectionery, it is used in a continuous production line for high boiled sweets to make 

perfectly clear sweets with minimum sugar inversion and with no air trapped. 

2. In bakery products it is used for direct acidification of bread. 

3. It increases butter stability and volume. 

4. It produces a mild and pleasant taste in acid pickles, relishes and salad dressings. 

5. Lactic acid suppresses Coliform and Mesentericur groups of bacteria. 

6. Lactic acid can be used as a meat carcass “wash” or in meat products to reduce microbial 

contamination.

7. It is used in jams, jellies, and frozen fruit desserts. 

8. In dairy products such as cottage cheese, the addition of lactic acid is preferred by some manufacturers 

to fermentation. 

9. Used in imitation dairy products such as non-dairy cheese and non-dairy yogurt powder. 

10. Lactic acid is widely used in preserving fruits, for example helping to maintain firmness of apple slices 

during processing. It also inhibits discoloration of fruits and some vegetables. 

11. Buffered lactic acid improves the taste and flavor of many beverages, such as soft drinks, mineral water 

and carbonated fruit juices. 

12. In breweries, lactic acid is used for pre-adjustments during the mashing process and during cooking. 

13. Acidification of lager beer with lactic acid improves the microbial stability as well as flavor. 

14. It is used in processing of meal in sauces for canned fish, to improve the taste and flavors and to mask 

amine flavor from fish meal. 

15. Lactic acid is used for flavor development and the control of microorganisms in soy cheese.

Manufacture:

First isolated in 1780 from sour milk, lactic acid can be produced both naturally and synthetically. It can be 

produced in either a solid, water-soluble state, or a colorless liquid state. Lactic acid is produced on an 

industrial scale through carbohydrate fermentation performed by lactic acid bacteria converting simple 

carbohydrates such as glucose, sucrose, or galactose to lactic acid. 

International Acceptance:

Lactic acid is permitted under all five major organic standards (US, EU, Canada, Japan Agriculture, and 

IFOAM). Canada classifies it as non-organic “for fermented vegetable products or in sausage”. CODEX 

permits its use “food of plant origin”, or “food of animal origin”. European Economic Council permits use in 

processing foodstuffs of both plant and animal origin, or for the regulation of pH in yeast production. Japan 

Agriculture Standards permits use in processed vegetables or rice products, sausage, for dairy products, and 

for cheese.

Environmental Issues:

The fermentation process produces calcium sulfate waste (sometimes sold as fertilizer) but it is not known 

to create any negative environmental impacts. 

Discussion:

Lactic acid is a “Direct Food Substance Affirmed as Generally Recognized as Safe,” or GRAS, as an 

antimicrobial agent, curing and pickling agent, flavor enhancer, flavoring agent and adjuvant, pH control 

agent, and as a solvent and vehicle, with no limitation other than current good manufacturing practice 

according to FDA regulations at 21 CFR 184.1061. 

NOSB October 2019 proposals and discussion documents Page 5 of 230
Uses from the 2019 spring public comment period include: an acidulant, flavor enhancer, buffer, 

coagulating agent, pH. control agent, as a carcass wash, and as a processing aid in conjunction with celery 

powder. In the organic produce sector it’s widely used in the formulation of disinfectants and sanitizers 

allowed for use in direct contract with organic food without the need for a rinse, a practice essential for 

complying with FSMA requirements.

Two commenters commented that lactic acid should be classified as synthetic, due to the material being a 

product of fermentation. 

No new information was brought forward in terms of harm to human health or the environment. 

Subcommittee Vote:

Motion to remove lactic acid based on the following criteria in the Organic Foods Production Act (OFPA) 

and/or 7 CFR 205.605(a) if applicable: NA

Motion by: Lisa de Lima

Seconded by: Asa Bradman 

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

Calcium chloride

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: Calcium chloride.

Technical Report: 1995 TAP

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use: Used in a wide variety of food processing applications including as a firming agent (in tofu, cut fruit 

and canning applications), as a sodium replacement, to adjust water mineral content in brewing 

applications and as a nutritional electrolyte application. 

Manufacturing: Calcium chloride can be obtained by extraction of nonsynthetic brines. When calcium 

chloride is extracted from a nonsynthetic source, its molecular structure is not changed during extraction 

and thus should be classified as nonsynthetic. The starting material is a natural brine solution that is 

pumped out from underground salt beds. Synthetic materials are used in the purification process, but 

without changing the chemical structure of the material. Calcium chloride may also be commercially 

obtained as a byproduct in the ammonia-soda (Solvay) process (TR 2015)

International: Calcium Chloride is allowed for use with various annotations under the Canadian, EU, 

Japanese, IFOAM and Codex standards.

NOSB October 2019 proposals and discussion documents Page 6 of 230
Discussion: For the Spring 2019 NOSB meeting the Handling Subcommittee posed the following question: 

Is this material currently in use by the organic food processing industry and in what applications? Public 

comment from trade associations, certifiers and manufacturers were supportive of relisting, noting that it is 

in use as a buffering agent in fruit preps, in cheese-making, in olive packing, in dairy analogs, as a 

disinfectant when used in conjunction with chlorine to mitigate effects on plant tissues, and as a tool to 

mitigate acrylamide in baking applications. Other comments were received from interest groups 

questioning the purity of commercially available calcium chloride at 6% impurities. The current United 

States Pharmacopeia Food Chemicals Codex (USP FCC) monograph for calcium chloride allows for up to 7% 

impurities. No context was given for why this is an area of concern. 

No new information was received by the NOSB supporting removal of this substance. 

Subcommittee Vote: 

Motion to remove calcium chloride from §205.605(a) of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Tom Chapman

Seconded by: Harriet Behar

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

Dairy cultures

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: Dairy cultures.

Technical Report: 1995 TAP; 2014 TR for Ancillary Substances

Petition(s): N/A

Past NOSB Actions: 05/2003 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Dairy cultures are used by organic dairy processors to make yogurt, cheese, cultured sour cream and other 

fermented milk products. The use of these cultures can increase the digestibility of milk products, create 

different flavors and textures, and provide potential health benefits to the consumer.

There are a variety of ways a dairy culture can be produced but generally a dairy or other medium is 

inoculated with a sample of the fermented food to produce a starter culture. Different microbiological 

species produce different flavor compounds and in turn produce different traditional dairy products. 

According to the 2014 technical report (TR) on microorganisms, there is widespread international 

acceptance of microorganisms and dairy cultures. 

Ancillary substances may be present in dairy cultures. Ancillary substances for microorganisms primarily 

include the growth media used to produce the microorganism and then fillers or carriers to bring the 

NOSB October 2019 proposals and discussion documents Page 7 of 230
microorganisms to purchasers in a stable and predictable form. Additional preservatives or anti-caking 

agents are used with some species. 

The Handling Subcommittee put forth a document listing the ancillary substances permitted for use in dairy 

cultures in 2015. These include: 

Functional class Substance name 

Anti-caking & anti-stick agents magnesium stearate, calcium silicate, silicon dioxide 

Carriers and fillers, agricultural or 

nonsynthetic 

lactose, maltodextrins, sucrose, dextrose, potato starch, non-GMO 

soy oil, rice protein, grain (rice, wheat, corn, barley) flour, milk, 

autolyzed yeast, inulin, cornstarch, sucrose. 

Carriers and fillers, synthetic 

micro-crystalline cellulose, propylene glycol, stearic acid, dicalcium 

phosphate. potassium phosphate, potassium sulfate, tricalcium 

phosphate. 

Preservatives sodium benzoate, potassium sorbate, ascorbic acid, sodium formate 

Stabilizers maltodextrin 

Cryoprotectants used to freeze-dry (& 

freeze) microorganisms and Dairy 

Cultures 

liquid nitrogen, maltodextrin, magnesium sulfate, dimethyl sulfoxide, 

sodium aspartate, mannitol, sorbitol , polysorbate 

Substrate that may remain in final 

product 

milk, lactose, grain (rice, barley, wheat) flour, brewed black tea and 

sugar, soy 

That document noted that use of these ancillary substances had not been found to cause negative effects. 

Additionally, as with all organic materials, any culture that is genetically modified is disallowed. 

Dairy cultures have been a staple in food production for centuries and they are generally viewed as a 

necessary input for organic production of certain dairy products. They pose minimal health risks, and in 

many cases can enhance health. In the October 2015, NOSB review of dairy cultures comments were 

received from trade associations, industry, certifiers and a technical organization. All comments were 

generally in favor of continued allowance of dairy cultures. The question was asked whether these should 

be listed separately or combined with microorganisms. Most industry stakeholders, while agreeing the 

dairy cultures were covered under microorganisms, still wanted a separate listing for dairy cultures. Several 

certifiers and a technical organization agreed that the listing of dairy cultures was redundant to 

microorganisms and could be removed. The ancillary substances used in dairy cultures has raised potential 

concerns about their compatibility with organic handling standards, but that has not prevented the support 

for continued listing of these cultures. 

Public comments received during the Spring 2019 NOSB meeting showed widespread support for relisting 

of the dairy cultures. Several comments noted issues with ancillary substances. One commenter noted 

that it was their understanding that liquid dairy cultures might contain preservatives such as sodium 

benzoate and that it should be reviewed as an ancillary substance. Additionally, the Food Additives Council 

submitted additional ancillary substances that should be added to dairy cultures:

NOSB October 2019 proposals and discussion documents Page 8 of 230
Food Additives Council list of ancillary substances submitted to NOSB meeting docket: AMS-NOP-18-0071, 

April 2019. Page 10 of document #: AMS-NOP-18-0071-0790

 Ancillary Substances for Food Cultures

 Substance Function

Magnesium sulphate Anti-caking

Silicon dioxide Anti-caking

Calcium chloride Carriers - Fillers

Casein hydrolysate Carriers - Fillers

Casein peptone Carriers - Fillers

Corn starch Carriers - Fillers

Dextrose monohydrate Carriers - Fillers

Fructose Carriers - Fillers

Lactose Carriers - Fillers

Maltodextrin Carriers - Fillers

Maltose Carriers - Fillers

Milk powder Carriers - Fillers

Peptone Carriers - Fillers

Rice hydrolizate Carriers - Fillers

Skim milk powder Carriers - Fillers

Sodium caseinate Carriers - Fillers

Sorbitol Carriers - Fillers

Starch Carriers - Fillers

Sucrose Carriers - Fillers

Trehalose Carriers - Fillers

Whey (powder) Carriers - Fillers

Whey protein Carriers - Fillers

Yeast Extract Carriers - Fillers

Zein from corn Carriers - Fillers

Lactase Enzyme

Nitrogen, liquid Freezing agent

Acetic acid pH control - buffer

Ammonium chloride pH control - buffer

Ammonium hydroxide pH control - buffer

Calcium carbonate pH control - buffer

Calcium phosphate dibasic pH control - buffer

Citric acid pH control - buffer

Dipotassium hydrogen phosphate pH control - buffer

Formic acid pH control - buffer

Monoammonium phosphate pH control - buffer

Monopotassium phosphate pH control - buffer

Phosphoric acid pH control - buffer

Potassium citrate pH control - buffer

Potassium hydroxide pH control - buffer

Sodium citrate pH control - buffer

Sodium hydroxide pH control - buffer

Sodium phosphate, monobasic pH control - buffer

Trisodium citrate dihydrate pH control - buffer

NOSB October 2019 proposals and discussion documents Page 9 of 230
Other commenters noted that the dairy culture listing no longer needs to be separated from the listing for 

microorganisms. One commenter stated: “During previous comment periods we have urged the NOSB to 

retain dairy cultures as a separate listing on the National List. This was in large part because at the time the 

NOSB was just beginning to have a more thorough review of ancillary substances, and we had some 

questions about whether this would affect the listing for dairy cultures. We now can see that the discussion 

document for microorganisms lists the same ancillary substances as those listed for dairy cultures, allaying 

our concern that combining these listings might inadvertently impact ancillary substances understood to be 

in dairy cultures. Now that there is more clarity on this point, we would not object to combining the dairy 

culture listing with the listing for microorganisms.”

While there is widespread support for the use of dairy cultures, the Handling Committee believes that this 

listing is now redundant and is covered by the listing for microorganisms. We would suggest that removing 

dairy cultures from the National List would have no negative impact since they are already covered under 

the microorganism listing. Functionally, these dairy cultures would continue to be allowed, just not listed 

under a separate category.

Subcommittee Vote: 

Motion to remove dairy cultures from §205.605(a) of the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Steve Ela

Seconded by: Scott Rice

Yes: 5 No: 0 Abstain: 0 Absent: 2 Recuse: 0

Enzymes

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: Enzymes—must be derived from edible, nontoxic plants, 

nonpathogenic fungi, or nonpathogenic bacteria.

Technical Report: 1995 TAP; 1996 TAP; 2011 TR; 2015 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2011 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Enzymes are naturally occurring proteins that act as highly efficient catalysts in biochemical reactions. They 

are used to carry out naturally occurring biological processes that are useful in the processing of food 

products or ingredients. Commonly used in the production of sweeteners, chocolate syrups, bakery 

products, alcoholic beverages, precooked cereals, infant foods, fish meal, cheese and dairy products, egg 

products, fruit juice, soft drinks, vegetable oil and puree, candy, spice and flavor extracts, and liquid coffee, 

and are used for dough conditioning, chill proofing of beer, flavor development, and meat tenderizing. 

Enzymes can also be used to help reduce production costs, reduce the length of time required for aging 

foods such as cheese, clarify or stabilize food products, and control the content of alcohol and sugar in 

certain foods (Enzyme Technical Association 2001). (Technical Report 2011 lines 140-148) 

NOSB October 2019 proposals and discussion documents Page 10 of 230
Microbial rennet describes a coagulating agent produced by a specific type of mold, fungus, or yeast 

organism, grown and fermented in a lab. (TR 2011 466-467) 

Fermentation produced chymosin (FPC) rennet is derived from genetically modified organisms and is not 

allowed in organic agriculture. 

Bromelain is extracted from the pineapple’s fruit, stem, peel and juice. First the fruit is crushed. Bromelain 

is then further isolated, separated, and purified using chromatography, ultrafiltration, precipitation, freeze 

drying, and other procedures. (TR 2011 494-496) 

Pectinase is produced by the controlled fermentation of nonpathogenic and nontoxicogenic strains of 

Aspergillus niger that are isolated from growth medium (FOA, 2000). (TR 2011 504-505) 

Ancillary substances are explained in the Enzymes Technical Evaluation Report – Limited Scope, (NOP 

2015): 

“Enzyme products used in food processing may be single ingredient, stand-alone preparations of 

the enzyme, or formulated with other ingredients (OMRI, 2015). In many cases the enzyme product 

which results from a fermentation process is not effective in food applications without further

formulation (Whitehurst & Van Oort , 2009). Enzyme preparations therefore commonly contain 

other substances, not only as incidental secondary metabolites and residual growth media from the 

enzyme production, but also intentionally added ingredients which function as diluents, 

preservatives, stabilizers, antioxidants, etc. (FDA, 2010). These additives must be generally 

recognized as safe (GRAS), or be FDA approved food additives for this use (FDA, 2014).” 

To prevent the loss of enzyme activity, ancillary substances, such as stabilizers, are added. This is especially 

true for liquid enzyme preparations due to the destabilizing effect of water. Stabilizers are also used to 

combat the degradation of enzyme structures due to autolysis or proteolysis. 

To control microbial contamination of enzyme preparations, preservatives are added. The development of 

alternatives to preservatives (plant extracts, peptides, compounds from herbs and spices) is increasing but 

there are microbial resistance challenges and the need for continued research. Currently it is unknown if 

natural preservatives are being used in any enzyme formulations. 

The following additional ancillary substances were identified through public comment during the last sunset 

review:

Anti-caking & anti-stick agents: calcium stearate, magnesium silicate/talc, magnesium sulfate, 

sodium aluminosilicate. 

Carriers and fillers: calcium phosphate, calcium acetate, calcium carbonate, calcium chloride, 

calcium sulfate, dextrin, dried glucose syrup, ethyl alcohol, glucose, glycol, lactic acid, maltose, 

mannitol, mineral oil, palm oil, propylene, purity gum (starch), saccharose, sorbitol, soy flour, soy 

oil, sunflower oil, trehalose, vegetable oil. 

Preservatives: alpha (hops) extract, benzoic acids and their salts, calcium propionate, citric acid, 

potassium chloride, potassium phosphate, sodium acetate, sodium chloride, sodium propionate, 

sodium sulfate, sorbic acid and its salts, stearic acid, tannic acide, trisodium citrate, zinc sulfate. 

NOSB October 2019 proposals and discussion documents Page 11 of 230
Stabilizers: betaine (trimethylglycine), glucose, glycerol, sodium chloride, sodium phytate, sorbitol, 

sucrose. 

pH control, buffers: acetic acid, citric acid anhydrous, sodium citrate, sodium phosphate, trisodium 

citrate. 

Public comment submitted during the Spring 2019 NOSB meeting suggest adding several other ancillary 

substances to this list:

Anti-Caking & Anti-Stick Agents: manganese sulphate, magnesium sulphate, microcrystalline 

cellulose powder

Carriers and Fillers: corn gluten, corn steep powder, dextrose, lactose, propylene glycol, soya flour, 

soya oil, soyatone, sucrose.

Preservatives: propyl p-Hydroxybenzoate, sodium metabisulfite, sodium nitrate.

Stabilizers: calcium lactate, ethylene diamine tetra acetic acid, glycerine, sodium alginate.

pH control, Buffers: adipic acid, di potassium phosphate (K2HPO4), diammonium phosphate, 

disodium phosphate (Na2HPO4), hydrochloric acid, mono potassium phosphate (KH2PO4), tri 

ammonium citrate.

During the last sunset review in 2015, a variety of organizations and manufacturers commented in support 

of keeping enzymes on the National List. There were no commenters opposed. One organization suggested 

that enzymes be classified as synthetic unless annotated to define those that have not undergone synthetic 

chemical change. The 2011 TR does not find the manufacture or use of enzymes to be harmful to the 

environment or biodiversity. Enzymes are used in small amounts, are biodegradable, and the release of 

enzymes into the environment is not an environmental concern. 

The 2011 TR does not find significant effects upon human health. Enzymes can remain active after they are 

digested and, as proteins, cause allergic reactions in sensitive individuals. FDA reports it is not aware of any 

allergic reactions associate with the ingestion of food containing enzymes commonly used in food 

processing (TR 2011 752- 758). 

Public comments received during the Spring 2019 NOSB meeting widely favored relisting of enzymes and 

numerous examples were listed of their use in organic handling. One group did object to the review of 

enzymes as a class noting that this broad review was insufficient to address classification and adherence to 

all OFPA criteria. They noted that enzymes should be classified as synthetic unless annotated to define 

those that have not undergone synthetic chemical change.

Subcommittee Vote: 

Motion to remove enzymes from §205.605(a) of the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Steve Ela

Seconded by: Harriet Behar

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

NOSB October 2019 proposals and discussion documents Page 12 of 230
L-Malic acid

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: L-malic acid (CAS # 97-67-6).

Technical Report: 2003 TR; 2019 TR

Petition(s): L-Malic Acid 11/01/02 

Past NOSB Actions: 05/2003 sunset recommendation; 11/2009 sunset recommendation 

Recent Regulatory Background: Added to National List 09/11/06 (71 FR 53299)

Renewed 08/03/2011 (76 FR 46595); Renewed 09/12/16 (81 FR 8821) 

Sunset Date: 9/12/2021

Subcommittee Review: 

(This summary references the 2019 TR unless otherwise noted)

Uses 

Malic acid exists in D-, L-, and racemic DL-forms, which is a mixture of equal parts of D- and L-. L-malic acid 

is the form listed at 205.605(a), while the D- and DL-forms are not approved for use in organic production. 

L-malic acid is used as a flavor enhancer, flavoring agent, adjuvant, and pH control agent in a variety of 

foods. The 2002 malic acid petition also notes it is used dry mix beverages, carbonated beverages, bakery 

products, fruit juices, candies, gelatins, desserts, frozen specialties, and tea as a flavor enhancer and food 

acidulant, and that malic acid provides greater tartness and better taste retention than other major food 

acids.

Malic acid has a smooth, persistent sourness and can be blended with other organic acids, sugars, 

sweeteners, and flavors. It also intensifies and extends the impact of flavors, allowing producers to reduce 

the amount of added flavoring.

U.S. Food and Drug Administration (FDA) lists L-malic acid as a Generally Recognized as Safe (GRAS) food 

additive as a pH control agent, flavor enhancer, flavoring agent, and adjuvant in all food types except for 

baby food. The listing also includes maximum good manufacturing practice (GMP) levels for various 

applications. (21 CFR Section 184.1069; U.S. FDA 2018)

Manufacture

L-malic acid occurs naturally in many fruits and vegetables, including apples and cherries and can be 

obtained by enzymatic conversion of fumaric acid and by fermentation of glucose and other carbohydrates. 

It is not economical to extract L-malic acid from natural foodstuffs such as apple juice.

In the first round of sunset review in Spring 2019, a number of commenters questioned whether 

commercially available L-malic acid is indeed from nonsynthetic sources, as this listing restricts. 

Commenters noted that while supporting documentation may state L-malic acid is produced naturally via 

enzymatic fermentation, this statement refers to only the second half of the process.

Industrial quantities of L-malic acid are made using biological processes, with the major industrial process 

to produce L-malic acid being a two-step procedure:

1. Production of fumaric acid either synthetically from petroleum or by fermentation of 

carbohydrates; and

2. Enzymatic conversion of fumaric acid to L-malic acid by immobilized microbes producing the 

enzyme fumarase. 

NOSB October 2019 proposals and discussion documents Page 13 of 230
There are two options for obtaining the fumaric acid in the first step in this process; more detailed 

information on the two-step process can be found in Appendix A of the 2019 Technical Report.

1. The fumaric acid precursor is obtained through the fermentation of carbohydrates (i.e., Rhizopus 

spp.)

2. The fumaric acid precursor is obtained as a synthetic product from maleic acid of petroleum origin

Commercial quantities of nonsynthetic L-malic acid may also be produced using a one-step fermentation 

process through biological methods such as microbial fermentation using Aureobasidium pullulans and 

Penicillium vitacola, though it is not believed that this process is occurring on a scale that would 

accommodate the needs of the current market. The major commercial source of L-malic acid is enzymatic 

conversion of synthetic fumaric acid to L-malic acid by immobilized microbes (Chibata et al. 1983; Chi et al. 

2016a; Dai et al. 2018). If the malic acid produced by this method is synthetic, most if not all, of the L-malic 

acid on the market is therefore synthetic (Goldberg et al. 2006; Chibata et al. 1983; Engel et al. 2008; Chi et 

al. 2016a; Dai et al. 2018).

L-malic acid can also be made from ethanol and biodiesel production waste but again, this is not the 

production method that commonly supplies the market. Thin stillage is a byproduct of corn fermentation in 

the production of ethanol from which Aspergillus niger ATCC 9142 can produce L-malic acid (West 2017). 

Another L-malic acid production process is the fermentation of crude glycerol obtained from production of 

biodiesel. Non-engineered Ustilago trichophora can be used for high yield production. A. niger MTCC 281 

can also produce L-malic acid from crude glycerol (Iyyappan et al. 2018ab).

L-malic acid can also be produced by microbes in a one-step fermentation processes fueled by glucose or 

other carbohydrates. Reaction conditions are adjusted to cause overproduction of L-malic acid, which is an 

essential product of microbe metabolism. 

The production of DL-malic acid is a synthetic process according to NOP Guidance 5033-1; the maleic acid

undergoes a chemical change that is not the result of a naturally occurring biological process (USDA 2016b). 

Note this is similar to the method of production for synthetic fumaric acid used as precursor for industrial Lmalic production.

Research quantities of D-malic acid and L-malic acid can be obtained by chemically separating the racemic 

DL-malic acid into its components in a process called chiral resolution. Chiral resolution is an expensive 

process that is not used to make large commercial quantities. D- or L-malic acid produced by chiral 

resolution is synthetic according to NOP Guidance 5033-1 because the isomers are isolated by chemical 

processes (USDA 2016b; West 2017).

International Acceptance

Canada, Canadian General Standards Board—CAN/CGSB-32.311-2015, Organic Production Systems 

Permitted Substances List

http://www.inspection.gc.ca/food/organic-products/standards/eng/1300368619837/1300368673172 

In Table 6.3, “Ingredients classified as food additives,” “Malic acid” is listed as a food additive with no 

restrictions (Canada 2018).

CODEX Alimentarius Commission—Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999)

http://www.fao.org/docrep/005/Y2772E/Y2772E00.HTM

NOSB October 2019 proposals and discussion documents Page 14 of 230
In Table 3 of “Annex 2: “Permitted substances for production of organic foods,” “Malic acid” with INS 296 is 

a permitted food additive listed without conditions (Codex 2001).

European Economic Community (EEC) Council Regulation—EC No. 834/2007 and 889/2008

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32007R0834

http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32008R0889 

Malic acid is not specifically mentioned in EC No. 834/2007. In EC No. 889/2008, Annex 8, “Certain 

productions and substances for use in organic processed foods,” “Malic acid” with E number 296 is allowed 

as a food additive (EU 2007; EU 2008). 

Japan Agricultural Standard (JAS) for Organic Production

http://www.maff.go.jp/e/jas/specific/criteria_o.html 

On page 4, “Attached Table 1, Food Additives,” DL-malic acid INS 296, is an approved food additive with the 

annotation, “Limited to be used for processed foods of plant origin”(JAS 2012).

IFOAM – Organics International 

http://www.ifoam.bio/en/ifoam-norms 

L-malic acid assigned INS 296 is listed on page 79 in Appendix 4, “Table 1: List of approved additives and 

processing aids for post-harvest handling.” L-malic acid is listed both as a food additive and post-harvest 

handling aid without restrictions (IFOAM 2014).

Environmental & Human Health Issues

The manufacture of L-malic acid by fermentation is fairly benign to the environment. Waste products such 

as spent cells and fermentation media can be composted. Processing chemicals include low toxicity acids 

and bases; while some of these can be recycled, they may end up in industrial landfills (West 2017; Dai et 

al. 2018). L-malic acid is found extensively throughout the environment in rotting fruit in agricultural or 

garden applications. Because it is soluble in water, L-malic acid eventually leaches out into the soil, where it 

is degraded by microbes. Manufactured malic acid is not deliberately released into the environment, and 

the amounts released incidentally into the environment through manufacturing processes and spills are 

likely to be small compared to the amounts already found in nature. The impacts of the manufactured 

material on beneficial insects, diversity, and other important aspects of environmental quality are negligible 

compared to natural exposures from rotting vegetation (Baker and Grant 2016).

Animal tests show that malic acid has low acute toxicity. Because it is easily metabolized in the body and 

occurs naturally in many fruits, there are no known reports of animal or human toxicity (Cornell 

Cooperative Extension 2016). Malic acid is an eye and skin irritant. The consumption of acidic soft drinks 

can lead to erosion of tooth enamel, and can cause tooth decay.

Discussion

A number of commenters noted that while there may have been nonsynthetic versions available in the 

past, it is unlikely that commercially available nonsynthetic quantities exist. As certifiers, material review 

organizations, and the 2019 TR attest, applying NOP Guidance 5033 and 5033-1 to this full production 

method would result in classifying L-Malic acid as a synthetic material. Until this material is reclassified, 

certifiers have been verifying the following for L-malic acid: that it is not made using the “big 3” (genetic 

modification, sewage sludge, irradiation); that it is L-malic acid (not DL- or D-); and that it is the form with 

the same CAS# as is identified on the National List.

NOSB October 2019 proposals and discussion documents Page 15 of 230
A number of certifiers noted that L-malic acid appears on the organic system plans of their certified 

operations and is still widely used. Several manufacturers also commented on the essentiality of this 

material to their production. A couple of organizations opposed relisting this material as information was 

based on an older TR that did not sufficiently address the manufacturing process. The updated 2019 TR 

appears to address these concerns with extensive information on the manufacturing process.

It is clear to the Subcommittee that this material should be reclassified and placed on 205.605(b) to reflect 

that the commercially available sources are a product of a synthetic manufacturing process. This 

reclassification cannot be completed via sunset review, so the subcommittee is proposing to relist this 

material and address the reclassification as a separate work plan item for consideration at a future meeting.

Subcommittee Vote: 

Motion to remove L-malic acid from §205.605(a) of the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Scott Rice

Seconded by: Tom Chapman

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

Magnesium sulfate

§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)).”

Reference: 205.605(a) Nonsynthetics allowed. Magnesium sulfate, nonsynthetic sources only. 

Technical Report:1995 TAP; 2011 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2011 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use: 

Magnesium sulfate has a wide variety of uses in food processing and personal care products. It is used as a 

firming agent in the production of tofu. According to the 2011 technical report (TR), magnesium sulfate is 

sometimes combined with other coagulators in the production of tofu. Magnesium sulfate is also used as a 

nutrient in salt-replacer products, dietary supplements, carbonated beverages, sports drinks and fortified 

water beverages, and as a fermentation and malting aid in beer, ale, and other malt beverages.

Magnesium sulfate is generally regarded as safe (GRAS), listed at 21 CFR 184.1443. The Food and Nutrition 

Board, an organization established by the Institute of Medicine that provides guidance to the public and 

policy makers on nutrition and food sciences, has recommended that cereal grain products be fortified with 

magnesium in response to the potential risk of deficiency among significant segments of the population. A 

common name for magnesium sulfate is Epsom salt.

NOSB October 2019 proposals and discussion documents Page 16 of 230
Manufacture: 

Several mineral forms of magnesium sulfate are recovered from the ground. The magnesium sulfate 

generally found in nature is in the hydrated form (i.e., contains water). Specifically, magnesium sulfate 

monohydrate and magnesium sulfate heptahydrate occur in nature as the minerals kieserite (MgSO4•H2O) 

and epsomite ((MgSO4•7H2O), respectively.

International: 

The Canada Food Inspection Agency, Food and Drug Regulations permit the use of non-synthetic sources of 

magnesium sulfate, which are classified as a food additive. Sulfates produced using sulfuric acid are 

prohibited.

Ancillary Substances: 

None identified.

Discussion: 

The 2011 TR notes that dietary doses of magnesium generally do not pose health risks. The TR does not 

fully address the environmental impact of mined forms of magnesium sulfate, noting it is not mined in the 

U.S. and therefore mining-related impacts are not an issue in the U.S. The TR does not address international 

mining impacts.

A number of alternative coagulants can be used in tofu production; however, these alternatives will affect 

texture, chewiness, color and other properties of the final product.

Calcium sulfate can be used in beer processing as an alternative to magnesium sulfate to increase water 

hardness and its mined form is on the National List.

While many other flavor enhancers are on the National List, it is unclear if any of these substances are 

suitable alternatives to magnesium sulfate.

Two food manufacturers noted their support of this material however, it was not clear if these 

manufacturers use this material. The Subcommittee is still seeking comment on the specific use and 

essentiality of this material.

Subcommittee Vote: 

Motion to remove magnesium sulfate from §205.605(a) of the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Scott Rice

Seconded by: Harriet Behar

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

Microorganisms

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: Microorganisms—any food grade bacteria, fungi, and other 

microorganism. 

Technical Report: 2003 TAP; 2014 TR; 2015 Ancillary Substances

Petition(s): 2002 petition

Past NOSB Actions: 09/2002 minutes and vote; 11/2009 sunset recommendation

NOSB October 2019 proposals and discussion documents Page 17 of 230
Recent Regulatory Background: Added to National List with annotation 09/11/06 (71 FR 53299)

Renewed 08/03/2011 (76 FR 46595); Renewed 09/12/16 (81 FR 8821)

Sunset Date 9/12/2021

Subcommittee Review: 

Microorganisms used in organic handling include those that are used as probiotics, for fermentation, and 

bacteriophages used for food safety. Microorganisms are used by organic processors to make many wellknown products including miso, shoyu, sake, and yogurts. The use of these microorganisms can increase 

the digestibility of products, create different flavors and textures, and provide potential health benefits to 

the consumer. Additionally, bacteriophages can work to decrease harmful food organisms and increase the 

safety of processed foods.

There are a variety of ways microorganisms can be produced. As noted in the 2014 technical report (TR), 

generally a medium is inoculated with a sample of the fermented food to produce a starter culture. 

Different microbiological species produce different flavor compounds and in turn produce different 

products. Depending on the organism desired, different mediums ranging from milk products to rice may 

be used to create the starter culture. After a culture is generated, the starter culture may be inoculated 

directly into a product that will be altered by the microorganisms or the culture may be preserved by 

drying, encapsulating, freezing or other method and used at a later time in the handling process. 

Ancillary substances may be present in microorganism cultures. Ancillary substances for microorganisms 

primarily include the growth media used to produce the microorganism and then fillers or carriers to bring 

the microorganisms to purchasers in a stable and predictable form. Additional preservatives or anti-caking 

agents are used with some species. 

The Handling Subcommittee put forth a document listing the ancillary substances permitted for use in 

microorganisms in 2015. These include: 

Functional class Substance name 

Anti-caking & anti-stick agents magnesium stearate, calcium silicate, silicon dioxide 

Carriers and fillers, agricultural or 

nonsynthetic 

lactose, maltodextrins, sucrose, dextrose, potato starch, non-GMO 

soy oil, rice protein, grain (rice, wheat, corn, barley) flour, milk, 

autolyzed yeast, inulin, cornstarch, sucrose. 

Carriers and fillers, synthetic 

micro-crystalline cellulose, propylene glycol, stearic acid, dicalcium 

phosphate. potassium phosphate, potassium sulfate, tricalcium 

phosphate. 

Preservatives sodium benzoate, potassium sorbate, ascorbic acid, sodium formate 

Stabilizers maltodextrin 

Cryoprotectants used to freeze-dry (& 

freeze) microorganisms and Dairy 

Cultures 

liquid nitrogen, maltodextrin, magnesium sulfate, dimethyl sulfoxide, 

sodium aspartate, mannitol, sorbitol , polysorbate 

Substrate that may remain in final 

product 

milk, lactose, grain (rice, barley, wheat) flour, brewed black tea and 

sugar, soy 

That document noted that use of these ancillary substances had not been found to cause negative effects. 

Additionally, the Food Additives Council submitted additional ancillary substances that should be added to 

microorganisms:

NOSB October 2019 proposals and discussion documents Page 18 of 230
Food Additives Council list of ancillary substances submitted to NOSB meeting docket: AMS-NOP-18-0071, 

April 2019. Page 10 of document #: AMS-NOP-18-0071-0790

 Ancillary Substances for Food Cultures

 Substance Function

Magnesium sulphate Anti-caking

Silicon dioxide Anti-caking

Calcium chloride Carriers - Fillers

Casein hydrolysate Carriers - Fillers

Casein peptone Carriers - Fillers

Corn starch Carriers - Fillers

Dextrose monohydrate Carriers - Fillers

Fructose Carriers - Fillers

Lactose Carriers - Fillers

Maltodextrin Carriers - Fillers

Maltose Carriers - Fillers

Milk powder Carriers - Fillers

Peptone Carriers - Fillers

Rice hydrolizate Carriers - Fillers

Skim milk powder Carriers - Fillers

Sodium caseinate Carriers - Fillers

Sorbitol Carriers - Fillers

Starch Carriers - Fillers

Sucrose Carriers - Fillers

Trehalose Carriers - Fillers

Whey (powder) Carriers - Fillers

Whey protein Carriers - Fillers

Yeast Extract Carriers - Fillers

Zein from corn Carriers - Fillers

Lactase Enzyme

Nitrogen, liquid Freezing agent

Acetic acid pH control - buffer

Ammonium chloride pH control - buffer

Ammonium hydroxide pH control - buffer

Calcium carbonate pH control - buffer

Calcium phosphate dibasic pH control - buffer

Citric acid pH control - buffer

Dipotassium hydrogen phosphate pH control - buffer

Formic acid pH control - buffer

Monoammonium phosphate pH control - buffer

Monopotassium phosphate pH control - buffer

Phosphoric acid pH control - buffer

Potassium citrate pH control - buffer

Potassium hydroxide pH control - buffer

Sodium citrate pH control - buffer

Sodium hydroxide pH control - buffer

Sodium phosphate, monobasic pH control - buffer

Trisodium citrate dihydrate pH control - buffer

NOSB October 2019 proposals and discussion documents Page 19 of 230
Potential concerns have been raised about ancillary substances used in cultures and their compatibility with 

organic handling standards. Functional foods may contain a combination of probiotic culture with a 

prebiotic substrate that favors its growth (2014 TR). The use of ancillary substances has not prevented the 

relisting and general support for microorganisms. In general, they have not been implicated in negative 

health effects, but are something that should be continually monitored. Additionally, as with all organic 

materials, any culture that is genetically modified is disallowed.

Microorganisms have been a staple in food production for centuries and they are generally viewed as a 

necessary input for organic production of many products. They pose minimal health risks, and in many 

cases can enhance health. As noted in the 2014 TR, the health effects can be expressed directly through 

the interactions of the ingestion of the live microorganisms (probiotic effect) or indirectly as the result of 

ingesting the metabolites synthesized by the microbes during fermentation (biogenic effect). Food-grade 

bacteria may also be used for improved vitamin production, raw food materials are often fortified with food 

grade bacteria that produce an excess of B vitamins in situ and bacteriophages are utilized as an 

antimicrobial to control bacteria during the production of foods on the farm, on perishable foods postharvest, and during food processing (2014 TR).

In general, microorganisms are essential to the production of many organic foods and they are widely used 

in the industry. Public comments received as part of the Spring 2019 NOSB meeting noted that 

microorganisms are essential to organic handling and there was widespread support for their relisting. 

Additional comments suggested combining the dairy culture listing with the microorganism listing since 

diary cultures are microorganisms. In the past there have been some commenters wanting to keep those 

listings separate due to the ancillary substances list being different for the two listings, however, at this 

point in time the ancillary substance list is suggested to be equivalent. Commenters that were against 

combining the two listings are now in favor of just listing microorganisms and having the dairy culture 

listing be part of the microorganism listing.

Finally, there were several comments about the definition of microorganisms. The definition is critical for 

microorganisms in use currently, and can be used to determine whether additional organisms, such as 

unicellular algae, should be considered microorganisms. One commenter noted that this listing is not clear 

stating: “It is apparent that it is intended to cover those microorganisms present as living organisms in 

foods such as cheese, yogurt, vinegar, pickles, tempeh, wine, and so forth. However, there are other 

products that are made from (or with the assistance of) microorganisms, and it is not clear whether the 

listing is intended to cover them. These include nutritional yeast and spirulina, both cultured 

microorganisms that are no longer living. They also include products of fermentation that have been 

isolated from the fermentation organisms, including glycerin, gellan gum, L-malic acid, and others. We 

assume that the listing does not cover the last group, but that those organisms and their manufacture

should be evaluated in the course of evaluating their products that are on the National List (NL). If the 

listing is intended to cover the group of killed microbial products, then the evaluation should include algae 

as well as the other organisms addressed in the technical review. These comments do not suggest that 

microorganisms should be delisted, but rather that additional attention needs to be paid to this particular 

listing and the definitions associated with it. 

Subcommittee Vote: 

Motion to remove microorganisms from §205.605(a) of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Steve Ela

Seconded by: Lisa de Lima

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

NOSB October 2019 proposals and discussion documents Page 20 of 230
Perlite

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: Perlite—for use only as a filter aid in food processing.

Technical Report: 1996 TAP

Petition(s): N/A

Past NOSB Actions: 09/1996 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022 

Subcommittee Review: 

Uses

Perlite is used as a filter aid in food processing, such as filtration of juices, beer, wine, and vegetable oils.

Manufacture

Perlite is an amorphous volcanic glass that occurs naturally and is sourced primarily from mines in the U.S., 

Greece, Turkey and China. The high-water content of the mineral causes it to expand many times its 

original volume when exposed to temperatures of 850-900 °C.

International

Canada General Standards Board Permitted Substances List allows the use of perlite as a filtering aid.

Codex Alimentarius lists perlite as a processing aid which may be used for the preparation of products of 

agricultural origin.

European Economic Community Council Commission Regulations (EC) No 834/2007 lists perlite for the 

preparation of foodstuffs of plant origin. In reference to use in foodstuffs of animal origin, its use is limited 

to gelatin.

IFOAM Norms Appendix 4 – Table 1 lists perlite as allowed for use as a processing and post-harvest 

handling aid. 

Japan Ministry of Agriculture, Forestry, and Fisheries limits the use of perlite for processed foods of plant 

origin.

UK Soil Association Standards for Food and Drink lists perlite for the preparation of foodstuffs of plant 

origin. In reference to use in foodstuffs of animal origin, its use is limited to gelatin.

Ancillary Substances

None identified.

Discussion

The listing of perlite has been consistently supported by the NOSB and organic stakeholders. There is some 

concern with the potential human health hazard of inhalation of fine silica dust when using this material. 

Personal protective equipment such as a dust mask can minimize this risk.

NOSB October 2019 proposals and discussion documents Page 21 of 230
During the first round of comments in spring 2019, several food manufacturers noted the use of this 

material for filtration and several certifiers noted its presence on the organic system plans of operations 

they certify.

Subcommittee Vote: 

Motion to remove perlite from §205.605(a) of the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Scott Rice 

Seconded by: Harriet Behar

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

Potassium iodide

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: Potassium iodide. 

Technical Report: 1995 TAP; 2011 TR 

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2011 Formal 

recommendation by the NOSB; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use: 

Potassium iodide is used as a form of iodine in trace mineral supplements. Iodine is an essential component 

of the thyroid hormones that regulate basal metabolism. Iodine deficiency causes thyroid enlargement 

(goiter), mental retardation that can be severe (cretinism in 10% of the population), and hypothyroidism. 

The developing brain is the most sensitive organ; iodine deficiency reduces IQ by 13.5 points. Iodization of 

salt completely eliminated new cases of cretinism in Switzerland. According to FDA, potassium iodide may 

be used as food additive in the following functions:

• A nutrient in table salt as a source of iodine

• A dietary supplement for human consumption and in animal feeds.

• A sanitizing agent for food processing equipment. (2015 TR pg 15)

Manufacture: Potassium iodide can be refined nonsynthetically from sea water and in salt deposits. It can 

be produced synthetically by reacting hydriodic acid with potassium bicarbonate or by electrolysis of 

hydriodic acid and potassium bicarbonate or, industrially, by treating potassium hydroxide with iodine. [21 

CFR 184.1634] (2015 TR pg 27).

International: Nonsynthetic potassium iodide is listed on the Canadian standards for use where required by 

law and the synthetic form is allowed in products in the 70-95% category. It could be used under the 

EU/Codex standards where required elsewhere by law. It is not listed on the Japanese or IFOAM standards. 

NOSB October 2019 proposals and discussion documents Page 22 of 230
Discussion: For the Spring 2019 NOSB meeting the Handling Subcommittee posed the following questions: 

Is Iodine utilized as a sanitizing agent for food processing equipment? If so, in what applications? If 

applications are for nutritional supplementation only – is this substance redundant to the current Nutrient 

Vitamin and Mineral listing? If so, should this separate listing be removed and are certifiers limiting the use 

of iodine to non-synthetic forms even with the synthetic allowance at 205.605(b) for the Nutrient Vitamin 

and Mineral listing? 

The NOSB did not receive any public comment about its use as a sanitizer. Public comment was received 

about its use in infant formula and in fortified foods. Regarding its redundant listing, one certifier 

commented in support of this being redundant to the more general nutrient vitamin and minerals listing. 

However, several comments about the general nutrient vitamin and minerals listing favored individual 

listing over the group listing. Lastly, one comment was received requesting an annotation to state “as a 

source of iodine” when required by law, however no context was given why the requiring law was not 

sufficient. 

No new information was received by the NOSB supporting removal of this substance. 

Subcommittee Vote: 

Motion to remove potassium iodide from §205.605(a) of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Tom Chapman

Seconded by: Scott Rice

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

Yeast

§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)).”

Reference: 205.605(a) Nonsynthetics allowed: Yeast—When used as food or a fermentation agent, yeast 

must be organic if its end use is for human consumption; nonorganic yeast may be used when equivalent 

organic yeast is not commercially available. Growth on petrochemical substrate and sulfite waste liquor 

is prohibited. For smoked yeast, nonsynthetic smoke flavoring process must be documented.

Technical Report: 1995 TAP (Smoked Yeast); 1995 TAP (Baker’s Yeast); 2014 TR

Petition(s): 2006 Petition; 2010 Petition Supplement; 2010 Petition memo 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 3/2007 NOSB 

committee recommendation; 10/2010 sunset recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290): Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Yeast is a microorganism that is commonly used for fermentation, baking, food flavors, adding nutritional 

value and providing health benefits. Yeasts are in kingdom Fungi and are single celled eukaryotic 

organisms. They utilize organic materials for energy by releasing enzymes that digest organic matter or by 

absorbing simple molecules directly through their cell walls. Yeasts differ from other fungi, such as molds 

and mushrooms, in that they exist as individual cells rather than forming hyphae that interconnect with 

other cells.

NOSB October 2019 proposals and discussion documents Page 23 of 230
In general, yeast species (brewer’s yeast) used in anaerobic conditions are for fermentation whereby they 

convert sugars to ethanol. This process includes ciders, beers, wines, and distilled spirits. Other uses for 

yeast are generally in aerobic conditions where they may be used as leavening agents (baker’s yeast), for 

the addition of vitamins or minerals (nutritional yeast, chromium yeast, selenium yeast, torula yeast), as 

probiotics that may prevent or treat pathological conditions (probiotic yeast), and for flavoring (smoked 

yeast, torula yeast) (2014 TR). As the TR notes, they may be used synergistically or in conjunction with 

bacteria or other materials to create specific foods such as when kombucha is fermented with yeast and 

acetic acid bacteria to create fermented, sweetened tea.

The way the yeast is used in processing as well as the action of the yeast depends on the type of end 

products produced as well as the specific type of yeast being utilized. 

Many yeasts are ubiquitous in the environment and in some cases handlers use these wild yeasts to make 

breads or for fermentation. However, since most handlers prefer more control over the specific type and 

strain of yeast that is utilized, most yeasts are grown under controlled conditions and then sold to end 

users. Typically, yeast is grown in a lab environment so as to prevent contamination from undesirable or 

pathogenic organisms. The lab grown yeast is then used to inoculate growth media for industrial 

production (2014 TR). In a number of cases there are several iterations of inoculation and addition of 

growth media in order to achieve the desired quantities. The yeast may then be used directly for food 

production or be concentrated and packaged for future use. Traditionally, smoked yeast is made by passing 

smoke through dried yeast, but it may also be manufactured using chemical processes. This necessitated 

the annotation that when smoked yeast is used, documentation that the yeast is smoked by natural 

processes must be submitted by the user. 

According to the 2014 TR, There are a few yeast species that are formulated with no ancillary substances, 

however, many commercially available yeasts are formulated with other ingredients. These substances, 

such as ascorbic acid, may be listed on the National List. However, other ancillary ingredients not 

appearing on the National List are routinely combined with yeast on a commercial scale. These may be 

water, emulsifiers, and cutting oils. The compounds used for emulsifiers are enumerated in the TR (2014 

TR) and that extensive list should be referred to for specific details of ancillary substances in yeast products. 

During the prior sunset review in 2015, the following Functional Classes were reviewed for ancillary 

substances in yeasts: Antioxidants, preservatives, emulsifiers, defoaming agents, and substrate that may 

remain in the final product. It was suggested that starch be added to this list during that review. One 

substance on the chart, BHT, was questioned as problematic for exposure.

Yeast is widely used and has been for centuries. Many organic products rely on the use of yeast for their 

distinctive features and characteristics. While there has been broad support for the relisting of yeast on the 

National List in past reviews, significant discussion has been centered on ancillary substances and whether 

organic forms of yeast are available. Yeast underwent a significant review that led to a change in the listing 

in 2010. The 2014 Technical Review added information about the current status of various yeasts and 

looked at the ancillary substances. There are many types of yeast and yeast is used to produce many 

substances, so this is a constantly changing playing field. As part of the prior sunset review many 

commenters noted that organic yeast forms are readily available, but that for certain uses there are some 

forms that are not yet organically produced in sufficient quantity or quality. These included torula yeast, 

nutritional yeast for livestock feed, gluten-free yeast, fresh yeast, and some types of wine yeast. This led to 

the extensive annotation for the listing of yeast on the National List. 

During the prior sunset review in 2015, the following Functional Classes were reviewed for ancillary 

substances in yeasts: Antioxidants, preservatives, emulsifiers, defoaming agents, and substrate that may 

NOSB October 2019 proposals and discussion documents Page 24 of 230
remain in the final product. It was suggested that starch be added to this list during that review. One 

substance on the chart, BHT, was questioned as problematic for exposure.

Finally, it should be noted that while yeast itself is often considered as a minimal risk material to both the 

environment and in use, there can be negative environmental impacts from the manufacturing processes 

used to create yeast formulations. Appropriate mitigation strategies for these impacts, such as the 

emissions of acetaldehyde and ethanol, exist and when appropriately used minimize environmental impact 

(2014 TR).

Public comment from the Spring 2019 meeting was overwhelmingly in favor of relisting of yeasts as 

annotated. Commenters noted that since yeast is commonly not available in organic form necessary for 

certain flavors, yeasts are not always available in the quantities needed, and that organic yeast quality can 

vary, the annotation and listing should remain as is.

Subcommittee Vote: 

Motion to remove yeast from §205.605(a) of the National List based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Steve Ela

Seconded by: Asa Bradman

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

NOSB October 2019 proposals and discussion documents Page 25 of 230
§205.605(b) Synthetics allowed:

Activated charcoal

§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)).”

Reference: 205.605(b) Synthetics allowed: Activated charcoal (CAS #s 7440-44-0; 64365-11-3)—only from 

vegetative sources; for use only as a filtering aid.

Technical Report: 2002 TAP

Petition(s): 2002 petition 

Past NOSB Actions: 09/2002 sunset recommendation ; 11/2009 sunset recommendation.

Regulatory Background: 

Added to National List with annotation 9/11/06 (71 FR 53299); Renewed 8/03/2011 (76 FR 46595); 

Renewed 09/12/16 (81 FR 8821)

Sunset Date: 9/12/2021

Subcommittee Review: 

Use

Activated charcoal is used in processing as mechanical filtration involving the physical separation of 

suspended solids from a liquid passing through carbon arrayed as a porous media in a column or bed. This 

type of filtration is used as a taste and odor-removing agent and purification agent in water and food. 

Activated carbon has a very large surface area and pore volume that gives it its unique adsorption capacity.

Manufacture

Activated charcoal of vegetative origin can be made from a large variety of sources such as hardwoods, 

grain hulls, corn cobs and nut shells. The material undergoes pyrolysis at a very high heat. These agricultural 

byproducts may be chemically activated using a variety of acids and bases. Acids may be acetic acid, and 

potassium hydroxide and sodium hydroxide are possible bases. The charcoal may also be activated through

exposure to oxygenated gas or steam.

International

Canada General Standards Board Permitted Substances List allows the use of activated charcoal as an 

ingredient classified as a food additive. Shall be of plant origin. Prohibited for use in the production of 

maple syrup.

Codex Alimentarius lists activated carbon as a processing aid which may be used for the preparation of 

products of agricultural origin.

European Economic Community Council Commission Regulations (EC) No 834/2007 lists activated carbon 

for the preparation of foodstuffs of plant origin.

IFOAM Norms Appendix 4 – Table 1 lists activated carbon as allowed for use as a processing and postharvest handling aid. 

Japan Ministry of Agriculture, Forestry, and Fisheries limits the use of active carbon for processed foods of 

plant origin.

NOSB October 2019 proposals and discussion documents Page 26 of 230
UK Soil Association Standards for Food and Drink lists charcoal for oenological use, with a restriction that 

limits use to musts and new wines still in fermentation, rectified concentrated grape must and white wines.

No more than 100g dry production per hl.

Ancillary Substances

None identified.

Discussion

Activated charcoal has minimal impact on human health and the environment. It may cause respiratory 

problems for those who handle it, especially as the particle size decreases. Its use in processing doesn’t 

generally have an effect or chemical interaction in the agroecosystem. The greatest impact of activated 

charcoal from vegetative sources is the removal of organic matter from the system. 

During the first round of comments in the spring, several food manufacturers noted the use of this product, 

with at least one stating they have not identified a suitable non-synthetic alternative. One organization 

wishes to see its use limited to filtration of water and limit the available forms to those made via steam 

activation.

Subcommittee Vote: 

Motion to remove activated charcoal from §205.605(b) of the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A

Motion by: Scott Rice

Seconded by: Asa Bradman

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

Alginic Acid 

§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)).”

Reference: 205.605(b) Synthetics allowed: Alginic acid (CAS #9005-32-7).

Technical Report: 2015 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2015 formal recommendation (reclassification)

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420); Proposed rule 1/17/2018 (83 FR 2498); Reclassified effective 01/28/2019 (83 FR 

66559) 

Sunset Date: 01/28/2024

Subcommittee Review: 

Use:

Alginic acid is used in the food industry as an emulsifier, emulsifier salt, formulation aid, stabilizer, and 

thickener for soups and soup mixes. FDA limits the use of alginic acid to soups and soup mixes. 

NOSB October 2019 proposals and discussion documents Page 27 of 230
Manufacture:

Alginic acid is derived from wild harvested brown cold-water seaweeds. Alginic acid exists naturally in both 

brown seaweeds and two bacterial genera. However, alginic acid is manufactured on an industrial scale 

through a chemical separation process that involves the maceration, alkali treatment, and acid precipitation 

of alginic acid from brown seaweeds. In order to separate alginic acid from its salt form, it is subjected to 

numerous pH adjustments to promote ion exchange. These chemical processes result in a pure alginic acid 

and its classification as a synthetic. Since alginic acid is present in seaweeds in its calcium, sodium, 

magnesium or other salt forms, and not in the free acid form, the free acid form does not appear in nature 

(2015 TR - Alginic Acid, Lines 283-286). 

International Acceptance:

The 2015 TR noted the following:

Canadian General Standards Board - permits the use of alginic acid under the Organic Production Systems 

Permitted List as a non-organic food additive. It is also found in the same table under the heading Alginates. 

CODEX – alginic acid is permitted under the Guidelines for the Production of Organically Produced Foods as 

a food additive of non-agricultural origin for foods of plant origin. The General Standard for Food Additives 

within CODEX list a number of provisional uses that FDA does not identify such as a bulking agent, foaming 

gent, glazing agent, in various food types. 

European Economic Community (EEC) lists alginic acid as an approved food additive for use in the 

production of processed organic foods. 

Japan Agricultural Standards (JAS) allows alginic acid as a food additive limited to only processed foods of 

plant origin. 

The International Federation of Organic Agriculture movements (IFOAM) lists alginic acid as an approved 

additive for use in organic processed products without any annotations.

Environmental Issues:

Alginic acid is derived from harvesting brown wild seaweed. There has been little research into production 

of alginic acid and alginates from a biological fermentation process. However, commercially available 

quantities are sourced from brown seaweed, (2015 Technical Review – Alginic Acid, Lines 299-300). Most 

are derived from wild harvested seaweed, but some seaweed is cultivated. Brown seaweed is harvested in 

cold water. Recent public comments expressed concern of over-harvesting and the impact on local 

ecosystems. Some negative comments cited that wild harvested seaweed is a bio-accumulator of heavy 

metals. 

Discussion:

In the 1995 TAP review for alginic acid, reviewers determined the material was non-synthetic. However, 

given the Classification of Materials document (in draft form in 2015) and the information presented in the 

2015 TR, it was recommended by the NOSB that alginic acid be reclassified as synthetic. In January 2019, it 

was relisted from 205.605(a) nonsynthetic, to 205.605(b) synthetic. The majority of public comment from 

the 2015 sunset review was in favor of relisting alginic acid. Those in favor of its relisting noted the long 

history of use with no ill effects on either the human digestive system or on the ecosystem due to 

harvesting and assert that the properties imparted by alginic acid are essential for some processed food 

formulations. Those opposed cited that wild seaweed is a bio-accumulator of heavy metals, and over 

harvesting was detrimental to local ecosystems. 

The Federal Register Notice published December 27, 2018, effective January 28, 2019 (Vol. 83, No.247, pp 

66559-66574), amends the National List and moves Alginic Acid from 606.605(a), nonsynthetic substances 

allowed etc. to 606.605(b), synthetic substances allowed etc. The complete listing under 205.605(b) is 

Alginic acid (CAS# 9005-32-7)

During the spring 2019 public comment period the board received no comments from manufacturers citing 

their use of alginic acid and there were no reports from certifiers of the material being included in any 

NOSB October 2019 proposals and discussion documents Page 28 of 230
Organic Systems Plans. One interest group asked that the listing be reviewed with the broader context of 

marine materials and to consider adding an annotation related to harvest restrictions and risk-based testing 

for toxic materials. Another commenter thought alginic acid should be delisted due to lack of essentiality 

and environmental impacts of seaweed cultivation. 

The TR reported no residues of heavy metals in excess of FDA tolerances. In regard to seaweed harvesting 

the TR reported that the majority of brown seaweed species harvested for production of alginic acid are 

wild harvested. However in countries like China & Japan large scale seaweed cultivation and production can 

negatively affect coastal waterways.

Questions:

1. Is alginic acid essential for handling operations? If so, why? 

2. The 2015 TR cites possible hydrocolloids alternatives including agar agar, carrageenan, gellan gum 

and xanthan gum. Please comment on whether or not these alternatives have been used 

successfully in place of alginic acid. 

Subcommittee Vote:

Motion to remove alginic acid based on the following criteria in the Organic Foods Production Act (OFPA) 

and/or 7 CFR 205.605(b) if applicable: Essentiality 

Motion by: Lisa de Lima

Seconded by: Harriet Behar

Yes: 5 No: 0 Abstain: 0 Absent: 2 Recuse: 0

Ascorbic acid

§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)).”

Reference: 205.605(b) Synthetics allowed: Ascorbic acid.

Technical Report: 1995 TAP; 2019 TR pending (to be posted at https://www.ams.usda.gov/rulesregulations/organic/national-list/a) 

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use:

Ascorbic acid is used as a dietary supplement and nutrient, flavor ingredient, used in meat and meat 

containing products, curing and pickling, in flour to improve baking quality, as an antioxidant in fats and 

oils, and a wide variety of other food processing uses. It is also used in frozen and precut fruits as an 

antioxidant. Industrially produced L-ascorbic acid is widely used in the feed, food, and pharmaceutical 

sector as a nutritional supplement and preservative, making use of its antioxidative properties. Ascorbic 

acid is often added to processed foods for nutritional purposes and is one of the most common sources of 

Vitamin C, which provides many important biological functions. Several animals, including humans, a 

NOSB October 2019 proposals and discussion documents Page 29 of 230
variety of primates and guinea pigs have lost the ability to produce ascorbic acid and must obtain this 

essential vitamin through their diets. As it is water soluble, and cannot be stored in the body, it must be 

consumed daily.

However, its addition as a nutritional fortifier also provides preservative properties. The preservative 

nature of the compound is derived from its reducing nature, through which it reacts with oxidized species 

(including radicals and molecular oxygen) to prevent enzymatic browning and food spoilage. 

Ascorbic acid is GRAS as a chemical preservative (21 CFR 182.3013), a dietary supplement (21 CFR

182.5013), and nutrient (21 CFR 182.8013) when used in accordance with Good Manufacturing Practices.

The FDA has identified ascorbic acid as a required nutrient in infant formula (21 CFR 107.100).

Manufacture: 

For more than 50 years, the predominant industrial production of ascorbic acid involved synthesis using the 

Reichstein and Grussner process, a six-step process developed in the 1930’s. The process begins with Dglucose and involves hydrogenation, oxidizing, and treatment with acetone and then hydrogen chloride to 

yield L-ascorbic acid. Despite the effectiveness of the purely synthetic production of ascorbic acid with the 

Reichstein process, most modern industrial production processes use fermentation with additional biooxidation steps adding a bio-catalyst which eliminates the need for the chemical steps. Despite the use of 

various microorganisms for the bulk of the synthesis, the use of acid in the final step of the process to 

convert the 2-keto-L-gluconic acid to ascorbic acid results in the substance’s classification as “synthetic,” 

according to the guidelines in NOP 5033-1. 

International Acceptance:

Canadian General Standards Board Permitted Substances List

Ascorbic acid is listed in the Canadian General Standards Board Permitted Substances List 

(CAN/CGSB-32.311-2015) in Table 4.2 as allowed for “soil amendments and crop nutrition,” and “synthetic 

and non-synthetic sources may be used as a pH regulator.” Ascorbic acid is listed in Table 6.3 as an 

“ingredient classified as a food additive,” and in Table 6.5 as a “processing aid for use as an anti-browning 

agent prior to the extraction or concentration of fruit or vegetable juice.” Table 7.3 lists ascorbic acid as a 

“food-grade cleaner, disinfectant, and sanitizer permitted without a mandatory removal event.” 

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999)

Ascorbic acid is listed in the CODEX (GL 32-1999) in Table 3.1 as a “food additive, including carriers.”

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

Ascorbic acid is not listed in EC No. 834-151 2007. Ascorbic acid is listed in EC No. 889/2008 as a “food 

additive, including carriers,” and is approved for “preparation of foodstuffs of plant origin and animal 

origin.” 

Japan Agricultural Standard (JAS) for Organic Production

Ascorbic acid is listed in the JAS for Organic Production Notification No. 1606 as a “food additive, limited to 

be used for processed foods of plant origin.”

International Federation of Organic Agriculture Movements (IFOAM)

Ascorbic acid is listed in IFOAM as an “approved additive and processing/post-harvest handling aid.”

Environmental Issues: 

The 2019 Technical Report found no published studies on the persistence or impacts to biodiversity of 

ascorbic acid. Given the natural prevalence of the substance in plants and animals, the incorporation of 

NOSB October 2019 proposals and discussion documents Page 30 of 230
ascorbic acid in the handling/processing of organic food products is unlikely to provide any significant 

increase to environmental levels of the substance. 

Discussion: 

During the first review in Spring 2019, the Subcommittee requested additional information on the use of 

excluded methods in the production of ascorbic acid. In the 2019 Technical Report, the authors note that 

the microorganisms employed for the synthesis of ascorbic acid are not genetically modified.

During the first review, public comment from a juice products trade group supported its relisting. Other 

comments noted its necessity for flavoring food products, as a pH adjustor for protein coagulation such as 

in protein processing and cheese production, color stabilization in fruit juice, and as an antioxidant and 

vitamin C source. Several certifiers noted its widespread presence in the organic system plans of the 

operations they certify. 

One interest group noted the predominant use of ascorbic acid is to fortify processed foods to preprocessing vitamin C levels. They further noted it is primarily used as a synthetic antioxidant and 

preservative and should be removed from the National List. The subcommittee notes that evaluation 

criteria at 205.600(b) restricting a material’s use as a preservative or its use to recreate or improve flavors, 

colors, textures, or nutritive value lost during processing is limited to processing aids and adjuvants.

The 2019 Technical Report notes alternative acids such as citric and lactic acid, nonsynthetic substances 

permitted at 7 CFR 205.605(a). These weak acids inhibit food discoloration, however the inability of these 

acids to provide the reducing power of ascorbic acid prevents preservative action against reactive oxidized 

species and limits their efficacy against viral contamination. The Technical Report cites the use of controlled 

atmosphere with little to no oxygen to retard microbial-based spoilage. However, the use of controlled 

atmospheres in packaging and processing has also been known to affect the color and other organoleptic 

properties of the foods. Other alternatives include the use of fruit juices to fortify foods. However, this 

strategy is limited; the relative instability of ascorbic acid and the presence of additional substances present 

in fruit juices that may result in undesired changes to the organoleptic properties of the processed foods.

Subcommittee Vote: 

Motion to remove ascorbic acid from §205.605(b) of the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Scott Rice

Seconded by: Harriet Behar

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

Calcium citrate

§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)).”

Reference: 205.605(b) Synthetics allowed: Calcium citrate.

Technical Report: 1995 TAP; 2015 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 4/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

NOSB October 2019 proposals and discussion documents Page 31 of 230
Subcommittee Review: 

Use: 

Calcium citrate is used as an ingredient in dietary supplements, although there are other calcium sources 

for supplementation purposes permitted at §205.605(b) under the listing Nutrient Vitamins and Minerals. 

Calcium citrate can be used as a sequestrant, buffer, antioxidant, firming agent, acidity regulator (in jams 

and jellies, soft drinks and wines), as a raising agent and an emulsifying salt. It is also used to improve the 

baking properties of flours and as a stabilizer. It can also be used as a water softener due to its chelation 

properties. It is used to wash processing equipment in order to eliminate off flavors, and as a pH adjuster 

and chelator in cleaning and sanitizing products. It is also used for its chelating properties to remove scale 

from boilers, evaporators and other processing equipment. Calcium citrate is widely used in cosmetic and 

personal care products for many of these same functions. 

Manufacture:

Calcium citrate is the calcium salt of citric acid. It is prepared by neutralizing citric acid with calcium 

hydroxide or calcium carbonate and subsequent crystallization. 

Citric acid is listed under 21 CFR 184.1195 as Generally Recognized as Safe (GRAS). It is prepared by 

neutralizing citric acid with calcium hydroxide or calcium carbonate. It is permitted in food with no 

limitations other than current good manufacturing practice. It is also permitted by FDA in infant formula. 

Calcium citrate is GRAS as listed at 184.1195

The EPA listed citric acid and its salts in the 2004 List 4A (minimal risk inerts). 

International: 

Allowed by Canada, European Economic Community (EEC) (as an ingredient in the preparation of foods of 

animal origin), and International Federation of Organic Agriculture Movements (IFOAM) (allowed as an 

additive). 

Ancillary Substances: 

According to the 2015 TR, citric acid and its salts (including calcium citrate) are commercially supplied as 

pure compounds and do not contain ancillary substances. 

Discussion: 

According to the 2015 TR, based on various toxicology studies, citric acid and its salts (including calcium 

citrate) are not expected to pose any significant health hazard upon ingestion. The manufacture of calcium 

citrate was not addressed in terms of potential harm to the environment. 

The TR cited the versatility of citric acid and its salts as the reason why no alternative practices could be 

used to substitute for all functions they provide. Additionally, there are no nonsynthetic sources or 

alternatives for the citrate salts.

2019 spring public comment was supportive and mentioned uses including: to fortify nutritional 

supplements with calcium, used in fruit filling to thicken and stabilize gel structures (yogurt, pastries), to 

develop a sugar-acid-pectin gel found in jams/jellies/fruit spreads, and as a buffer in fruit and flavor preps. 

One commenter would like to see all the citrates be restricted to uses that are compliant with 

205.600(b)(4), however that restriction only applies to processing aid and adjuvants. 

No new information was brought forward in terms of harm to human health or the environment. 

Additional information requested by subcommittee: None

NOSB October 2019 proposals and discussion documents Page 32 of 230
Subcommittee Vote:

Motion to remove calcium citrate based on the following criteria in the Organic Foods Production Act 

(OFPA) and/or 7 CFR 205.605(b) if applicable: NA

Motion by: Lisa de Lima

Seconded by: Asa Bradman

Yes: 0 No: 5 Abstain: 2 Absent: 0 Recuse: 0

Ferrous sulfate

§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)).”

Reference: 205.605(b) Synthetics allowed: Ferrous sulfate—for iron enrichment or fortification of foods 

when required by regulation or recommended (independent organization).

Technical Report: 1995 TAP; 2015 TR Nutrient Vitamins and Minerals

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use: Ferrous sulfate is commonly added to flours and cereal products to make an optional enriched claim 

and often found in baked products and infant snacks (oat cereal, teething biscuits, etc.). Iron is an essential 

component of hemoglobin, enzymes involved in energy metabolism, and other enzymes. Hemoglobin 

transports oxygen to body tissues. Iron deficiency leads to anemia, poor work performance and endurance, 

persistent cognitive and developmental impairment, increased maternal perinatal mortality and a greater 

rate of premature labor and delivery, and depressed immune function. (2015 TR, pg 15)

Manufacture: Ferrous sulfate is made by reacting sulfuric acid with iron. [21 CFR 184.1315] (TR 2015, pg 28)

International: Ferrous sulfate is listed on the Canadian standards for use where required or allowed, it 

could be used under the EU/Codex standards where required elsewhere by law. It is not listed on the 

Japanese or IFOAM standards. 

Discussion: For the Spring 2019 NOSB meeting the Handling Subcommittee posed the following question: If 

applications are for nutritional supplementation only – is this substance redundant to the current Nutrient 

Vitamin and Mineral listing? If yes, should this item be removed? Comments were received in support of 

this listing from industry, noting its use in infant formulas. There was some support for removing this listing 

as redundant to the Nutrient Vitamins and Minerals listing but there was also opposition to the group 

listing of vitamins and minerals. One interest group questioned if ferrous sulfate was the best source of 

iron supplementation or if alternatives were available. They also noted a whole-food diet could be 

sufficient to meet iron deficiencies. Alternatives were not offered and details on how a whole-food diet 

would be sufficient for various and diverse populations, including those at risk for iron deficiency were not 

provided. 

No new information was received by the NOSB supporting removal of this substance. 

NOSB October 2019 proposals and discussion documents Page 33 of 230
Subcommittee Vote: 

Motion to remove ferrous sulfate from §205.605(b) of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Tom Chapman

Seconded by: Asa Bradman

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

Hydrogen peroxide

§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)).”

Reference: 205.605(b) Synthetics allowed: Hydrogen peroxide.

Technical Report: N/A (2015 TR Crops) 

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use:

Hydrogen Peroxide (CAS# 7722-84-1) is a very simple molecule with a formula of H2O2. It is a weak acid 

but also a strong oxidizer which makes it an effective microbial pesticide for organic handling purposes. 

It is used as a disinfectant and sanitizer and also for post-harvest treatment of produce. USDA organic 

regulations currently allow the use of hydrogen peroxide in organic crop production under 7 CFR

§205.601(a) as an algicide, disinfectant and sanitizer, and under 7 CFR 205.601(i) for plant disease 

control as a fungicide. Hydrogen peroxide is also permitted for use in organic livestock production as a 

disinfectant, sanitizer and medical treatment (7 CFR 205.603(a)). Lastly, synthetic hydrogen peroxide 

may be used as an ingredient in or on processed products labeled as “organic” or “made with 

organic(specified ingredients or food group(s)).” (7 CFR 205.605(b)).

Manufacture:

According to the TR, commercially available hydrogen peroxide is industrially produced using the 

anthraquinone autoxidation (AO) process. The AO method involves initial catalytic reduction of an alkyl 

anthraquinone with hydrogen to form the corresponding hydroquinone. Subsequent autoxidation of the 

hydroquinone intermediate in air regenerates the anthraquinone with concomitant liberation of 

hydrogen peroxide. The simplified overall reaction involves direct combination of gaseous hydrogen (H2) 

and oxygen (O2): H2+ O2→H2O2

International:

Canada: Allowed for many uses, including as food-grade cleaners, disinfectants and sanitizers” that are 

allowed without mandatory removal of residues, and “cleaners, disinfectants and sanitizers allowed on 

food contact surfaces including equipment, provided that substances are removed from food contact 

surfaces prior to organic production”. 

NOSB October 2019 proposals and discussion documents Page 34 of 230
European Union: Allowed for similar uses to Canada and U.S.

IFOAM: Allowed as cleanser and disinfectant among other uses. 

Japan: Not listed.

Codex: Allowed as a cleanser and disinfectant among other uses

Ancillary substances:

Other ingredients may include peroxyacetic acid (listed separately on the National List). The TR reports 

other potential materials present including caprylic acid and mono-and di-potassium salts of phosphorous 

acid, which is an oxidant stabilizer. Phosphorous acid is listed on the EPA Safer Choice list as a yellow 

triangle.1

Human Health and the Environment:

Concentrated solutions may be corrosive to eyes, exposed skin, and mucous membranes. Warnings for 

high concentrations include:

Corrosive. Causes irreversible eye damage. May be fatal if swallowed or absorbed through the skin. 

Causes skin burns or temporary discoloration on exposed skin. Do not breathe vapor. Do not get in eyes, 

on skin or on clothing. Wear protective eyewear such as goggles or face shield. Wash thoroughly with 

soap and water after handling. Remove and wash contaminated clothing before reuse.

Extensive toxicological testing of hydrogen peroxide has been completed, and it is unlikely to cause 

chronic systemic toxicity or reproductive, development, or carcinogenic effects. However, chronic 

exposure to vapors may damage lungs. Hydrogen peroxide is reported to have low to moderate toxicity 

to aquatic invertebrates and no danger to fish. Because hydrogen peroxide is unstable and breaks down 

into water and oxygen gas, long-term impacts on the environment are unlikely. According to the TR, 

some toxic chemicals used to manufacture hydrogen peroxide including alkyl anthraquinones, aromatic 

solvents and metal catalysts (e.g., nickel and palladium) are removed from the product and can be 

returned to the reactors to make more product. Overall, this material is relatively safe but should be 

used according to FDA, USDA, and EPA labels and regulations.

No new information was brought forward in terms of harm to human health or the environment. 

Discussion:

Hydrogen peroxide (HP) continues to receive strong support by the organic community and has been 

consistently relisted on the National List. Oral and written comments submitted for the Spring 2019 

NOSB meeting represent hundreds if not thousands of crop and livestock farmers and processors who 

uniformly support relisting this essential and relatively safe material. When used appropriately HP 

should not have adverse impacts on human health and the environment. 

Additional information requested by subcommittee: None

Subcommittee Vote: 

Motion to remove hydrogen peroxide from 205.605(b) of the National List based on the following criteria in 

1 Yellow triangle - The chemical has met Safer Choice Criteria for its functional ingredient-class, but has some hazard 

profile issues. Specifically, a chemical with this code is not associated with a low level of hazard concern for all human 

health and environmental endpoints. (See Safer Choice Criteria). While it is a best-in-class chemical and among the 

safest available for a particular function, the function fulfilled by the chemical should be considered an area for safer 

chemistry innovation.

NOSB October 2019 proposals and discussion documents Page 35 of 230
the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Asa Bradman

Seconded by: Steve Ela

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

Nutrient vitamins and minerals

§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)).”

Reference: 205.605(b) Synthetics allowed: Nutrient vitamins and minerals, in accordance with 21 CFR 

104.20, Nutritional Quality Guidelines For Foods. 

Technical Report: 1995 TAP - Minerals; 1995 TAP - Vitamins; 2015 TR 

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2011 Handling 

Subcommittee Proposal; 04/2011 sunset recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use: 

Nutrient Vitamins and Minerals are used to recreate or add nutritional content to foods. Sometimes this 

nutritional content is added due to public health guidance (e.g. Iron in cereal to combat iron anemia), to 

mimic analog products (calcium fortification of non-dairy milks, fortification of infant formulas), to make up 

nutrients lost in processing (Vitamin A in skim milk) or for product marketing purposes (enriched flours). 

There are very few legally required fortified foods. Those that are required are listed on the chart below, 

noted from the 2015 technical review:

Standards of Identity in Title 21 CFR that require Nutrient Fortification 

Food class Regulation Specific vitamins or minerals required by FDA 

Infant formula 21 CFR 107.100 All nutrients known to be essential and listed therein 

21 CFR 107.10 

Margarine 21 CFR 166.110 Vitamin A 

Milk 21 CFR Part 131 Vitamins A & D (required by some states) 

There are more food classes with standards of identity that allow for the use of fortification, however these 

fortifications are optional. It should be noted that foods eligible for the “Women, Infants and Children” 

federal programs may be required to be the fortified standard of identity form. 

The specific use of vitamins and minerals will depend application and on the specific substances being used. 

Vitamins in application are substances with vitamin activity and there are several substances that may have 

a vitamin activity for a specific vitamin. Similarly, for minerals the substances used are those with 

bioavailable mineral content. These substances will often be processed with accessory additives to make 

the vitamins or minerals stable and useable in food applications.

Manufacturing: The 2015 technical review states:

NOSB October 2019 proposals and discussion documents Page 36 of 230
According to Vandamme (Vandamme 1992), “vitamins are now either prepared chemically or 

biotechnologically via fermentation or bioconversion processes. Several vitamins and related 

biofactors are now (1992) only or mainly produced chemically (vitamin A, cholecalciferol (D3), 

tocopherol (E), vitamin 432 K2, thiamine (B1), niacin (PP or B3), pantothenic acid (B5), pyridoxine 

(B6), biotin (H or B8), folic acid (B9)]or via extraction processes (β-carotene or provitamin A, 

provitamin D3, tocopherol, vitamin F-group). However, for several of these compounds 

microbiological or algal methods also exist or are rapidly emerging. Other vitamins are produced 

practically exclusively via fermentation (ergosterol or provitamin D2, riboflavin (B2), 

cyanocobalamin (B12), orotic acid (B13), vitamin F-group ATP, nucleosides, coenzymes, etc.] or via 

microalgal culture (β-carotene, E, F). Both chemical and microbial processes are run industrially for 

vitamin B2, while vitamin C (ascorbic acid) is produced via a combination of chemical reactions and 

fermentation processes. In the past twenty-five years, numerous patents have been issued 

disclosing fermentations by genetically modified microorganisms to produce various water-soluble 

vitamins... As the above descriptions detail, most vitamin and mineral nutrients are synthetic 

substances, even including some with natural or agricultural origins... Most vitamins and minerals 

are not available from nonsynthetic sources.... The current National List listings creates confusion 

for those nutrient vitamins and minerals specifically listed at §205.605(a), which requires a 

nonsynthetic source, whereas “Nutrient vitamins and mineral” are a class of “allowed synthetics.” 

For example, the producer of a nutritional product may not be sure if supplemental magnesium as 

magnesium sulfate is restricted to a nonsynthetic source. “

The technical report details many individual manufacturing methods. 

International: 

The Codex and EU standards only allow the use of synthetic vitamin and minerals where required by law. 

The Canadian standards allow synthetic vitamin and minerals where required by law as well as in “nondairy substitute products” on a “voluntary basis, if legally permitted.” Canadian standards also allow for 

use of “Ferrous sulphate—Shall be used if legally required and may be used, on a voluntary basis, if legally 

permitted.” IFOAM allows by law or when “strongly recommended in food products in which they are 

incorporated.” Japanese standards do not allow for vitamins and minerals (2015 TR, pg 20-21). All 

standards list some substances that may be considered vitamins and minerals (i.e. ascorbic acid or calcium 

carbonate) – the review above does not include these individual substances, just categorical listings. 

Discussion: 

Brief History of this issue

• In 1995 the NOSB added nutrient vitamins and minerals to the National List with the following 

annotation, ‘‘Accepted for use in organic foods for enrichment or fortification when required by 

regulation or recommended by an independent professional organization.’’ A second 

recommendation was also passed entitled ‘‘Final Recommendation Addendum Number 13, The Use 

of Nutrient Supplementation in Organic Food.’’ This stated, ‘‘Upon implementation of the National 

Organic Program (NOP), 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 final rule that was published in 2000 (65 FR 13512) had the current annotation. It was 

recognized soon after that the cross reference to the FDA’s fortification policy for food at 21 CFR 

104.20 was not accurate and that a correction to the current listing was necessary. 

• In 2007 the NOP provided an interpretation of the regulation that mistakenly concluded that 21 

CFR 104.20 allowed a wide variety of nutrients that were not limited to just vitamin and minerals.

NOSB October 2019 proposals and discussion documents Page 37 of 230
In 2010 the NOP met with the FDA to clarify the meaning of the FDA guidance at 21 CFR 104.20. 

The NOP issued a memo to the NOSB in April 2010 explaining this clarification.

• The existing annotation is not what the original NOSB recommended in 1995. In 2011 the Handling 

Subcommittee proposed to change the annotation at sunset but received approximately 2000 

comments against it due to concerns about broadening the scope. The Subcommittee withdrew the 

proposal prior to the April 2011 NOSB meeting and the NOSB supported relisting with the existing 

annotation for the 2012 sunset review. 

• On January 12, 2012 a proposed rule was published in the Federal Register (77 FR 1980) to change 

the annotation to: § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or 

on processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food 

groups(s)).’’ 

(b) Synthetics allowed, 

Vitamins and minerals. For food— vitamins and minerals identified as essential in 21 CFR 101.9. For 

infant formula—vitamins and minerals as required by 21 CFR 107.100 or § 107.10.

• This proposed rule clarified that the "nutrients" that were not on these CFR sections had to be 

petitioned individually for the National List because this listing did not cover them.

• NOP did not finalize the proposed rule, but on September 27, 2012 published an Interim Rule (77 

FR 59287), which renewed without change the original listing, as per the NOSB April 2011 

recommendation.

• In 2011 through 2013 many other nutrients were petitioned. Some were recommended to be listed 

by the NOSB while others were not. No rulemaking in this area has occurred.

• In 2014 the Handling Subcommittee commissioned a new Technical Report in preparation for 

Sunset 2017 reviews. This was completed in February 2015 and clarifies which substances are 

required and permitted and which are covered by the 21 CFR citations or other regulations.

• In 2015 the NOSB voted to renew the listing and included the following note about the technical 

review and public comment:

“Since this is a huge group of different substances, the TR went into length about their 

manufacturing processes, effects on human health, effects on the environment and uses. There 

was no information among these pages that gave concern that these substances did not meet the 

review criteria. Likewise public comment was received with concerns about the unnecessary use of 

synthetic ingredients, but no new information was provided in comments from the first posting 

regarding the review criteria beyond the alternatives and compatibility issues.

Regarding alternatives, the primary alternative is for people to get their vitamins and minerals from 

the food itself rather than supplementation. ...There is no literature to suggest that the 

manufacture or use of vitamins and minerals with ancillary substances is harmful to the 

environment or to biodiversity." 

• In 2016 the Handling Subcommittee brought forward a discussion document with two options:

Option 1

Proposed Annotation #1: §205.605 (b) Vitamins and minerals, synthetic. For food – 

Minerals (including trace elements), vitamins and similar isolated ingredients are allowed 

NOSB October 2019 proposals and discussion documents Page 38 of 230
only when their use is required by law or to meet an FDA standard of identity in which they 

are incorporated. 

Proposed Annotation #2: §205.605 (b) Vitamins and minerals, synthetic. For food – 

Minerals (including trace elements) and vitamins identified as essential in 21 CFR 101.9. For 

infant formula—vitamins and minerals as required by 21 CFR 107.100 or § 107.10 are 

allowed for use in agricultural products labeled “made with organic (specified ingredients 

or food group(s)),” prohibited in agricultural products labeled “organic” (except as noted in 

annotation #1).

Proposed Annotation #3: §205.605 (a) Vitamins and minerals, non-synthetic. For food – 

Minerals (including trace elements) and vitamins identified as essential in 21 CFR 101.9. For 

infant formula—vitamins and minerals as required by 21 CFR 107.100 or § 107.10 are 

allowed for use in agricultural products labeled Organic.

Option 2

Proposed Annotation #4: §205.605 (b) Vitamins and minerals, synthetic. For food – 

Minerals (including trace elements) and vitamins identified as essential in 21 CFR 101.9. For 

infant formula—vitamins and minerals as required by 21 CFR 107.100 or § 107.10 are 

allowed for use in agricultural products labeled "organic" and “made with organic (specified 

ingredients or food group(s))”.

• To Date the NOSB has taken no further action on this subject

During the 2019 sunset cycle the NOSB posed the following questions for public comment at the Spring 

meeting:

1. Is the current listing meeting the needs of the organic community, certifiers and industry – if not, 

how should it be revised? 

2. How are certifiers dealing with non-synthetic nutrient vitamins and minerals currently?

3. It is speculated that the 2012 rulemaking was stopped due to the impact this change would have on 

the currently established organic infant formula market which has both established manufacturers 

and consumers. How should the NOSB move this topic forward in light of this issue?

4. Given added Vitamins and Minerals need to be listed on ingredient panels, are consumers enabled 

enough to make educated purchasing decisions on fortified foods – if not, please explain. 

In response to the first question – public comment was mixed, with some commenters wanting more 

restrictions and some wanting a wide interpretation. Those using the widest interpretation either 

supported status quo or a change in annotation that would enshrine the status quo. Most certifiers 

thought the accuracy of the citations needed improvement, and it needed to be clearly enforceable. 

Others are seeking a more restricted listing. It should be noted that any annotation changes would need to 

be completed separate from this sunset review. 

In response to question 2: Certifiers indicated that all were using the synthetic allowance as an allowance 

for non-synthetic usage and generally did not go into detail about how these materials are being 

manufactured. One certifier noted that non-synthetic versions were sometimes agricultural and would 

potentially require listing on 205.606. While clarification was supported by certifiers, no problematic or 

conflicting interpretations were raised. 

In response to question 3: Commenters provided many suggestions on how to move forward on this topic, 

ranging from re-reviewing previous NOSB decisions on petitioned items, to supporting the 2012 proposed 

rulemaking to removing the categorical listing all together. Short of removing this listing in its entirety 

during a sunset review, recommendations on annotation changes would need to be considered as part of 

different work agenda item other than this sunset review. 

NOSB October 2019 proposals and discussion documents Page 39 of 230
Lastly, all commenters responded to the fourth question stating consumers were empowered with enough 

information to understand which products are fortified. 

Overall there was strong support of this listing from industry and trade associations – noting the use of 

materials for reasons such as compliance with the law, to compete with conventional product, due to 

consumer expectations, or to make products for specific markets like infant food or enteral feeding 

products. Opposition to this listing came from interest groups who opposed the categorical listing of 

nutrient vitamins and minerals, that opposed a listing pointing to an incorrect FDA reference, and a 

reference to a list maintained by someone other than the NOSB. Concern was also raised over allowing the 

fortification of food in instances not required by law, and lastly about the categorical listing allowing for the 

continued usage of individual substances that had been reviewed but not recommended by the NOSB. 

The public comment received in 2019 was similar to the public comment received in 2015 and no 

substantial new information was received supporting the removal of this listing.

Subcommittee Vote: 

Motion to remove nutrient vitamins and minerals from §205.605(b) of the National List based on the

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Tom Chapman

Seconded by: Harriet Behar

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

Peracetic acid

§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)).”

Reference: 205.605(b) Synthetics allowed: 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.

Technical Report: 2000 TAP; 2016 TR

Petition(s): 2008 Petition

Past NOSB Actions: 11/2000 sunset recommendation; 04/2004 NODB meeting summary; 11/2009 NOSB 

formal recommendation 

Recent Regulatory Background: Added to National List with annotation 9/11/06 (71 FR 53299); Renewed 

8/03/2011 (76 FR 46595); Renewed 09/12/16 (81 FR 8821)

Sunset Date: 9/12/2021

Subcommittee Review: 

Use:

Peracetic acid (CAS # 79-21-0) is currently allowed for use in organic handling in wash water and rinse 

water, including during post-harvest handling, to disinfect organically produced agricultural products 

according to FDA limitations, and to sanitize food contact surfaces, including dairy-processing equipment 

and food-processing equipment and utensils. It is an important sanitizer used in organic handling. It is 

widely used as a sanitizer on food contact surfaces and as a disinfectant for fruits and vegetables. 

Peracetic acid/Peroxyacetic acid was added to the National List on September 12, 2006, with the 

annotation, “for use in wash and/or rinse water according to FDA limitations. For use as a sanitizer on 

food contact surfaces.” (It is also on the National List at §205.601 and §205.603 for use in Crops and 

NOSB October 2019 proposals and discussion documents Page 40 of 230
Livestock respectively). Peracetic acid disinfects by oxidizing the outer cell membrane of vegetative 

bacterial cells, endospores, yeast, and mold spores, making it an effective sanitizer against all 

microorganisms, including bacterial spores. The end products of peracetic acid oxidation are acetic acid 

and water.

Manufacture:

According to the 2016 technical report (TR), solutions of peracetic acid used as sanitizers are created by 

combining aqueous mixtures of two substances: acetic acid (the acid in vinegar) and hydrogen peroxide. 

At cool temperatures, acetic acid and hydrogen peroxide react over a few days to form an equilibrium 

solution containing peracetic acid, acetic acid, and hydrogen peroxide. The equilibrium solution is the 

substance sold commercially as the sanitizer “peracetic acid.” Solutions of peracetic acid, hydrogen 

peroxide, acetic acid and water are produced by reacting glacial acetic acid with hydrogen peroxide, 

often in the presence of a catalyst such as a mineral acid (e.g., sulfuric acid). Commercial grades are 

available in concentrations ranging from about 0.3 to 40 % by weight. A peracetic acid solution can also 

be generated in situ by dissolving an activator and a persalt in water or on site by adding sodium 

hydroxide to triacetin and hydrogen peroxide.

International:

Japan: Not listed 

Codex: Not listed. 

Canada: Allowed 

IFOAM: Allowed

European Union: Allowed

Ancillary substances:

HEDP and dipicolinic acid (DPA) are added to peracetic acid solutions to chelate metals, especially iron, 

copper and manganese, because decomposition of peracetic acid and, thus, loss of sanitizing power is 

accelerated by these impurities. However, in past reviews, stakeholders did not declare the inclusion of 

ancillary substances (See below).

Human Health Environment:

peracetic acid likely has no significant environmental impacts. Like other oxidative sanitizers (i.e., 

chlorine compounds), concentrated solutions of peracetic acid are strong irritants to the skin, eyes, 

mucous membranes, and respiratory system. As reviewed in the TR, when using fully diluted sanitizing 

solutions, no special eye, hand, skin, or respiratory protective equipment is normally required. No risk 

through dietary exposure is anticipated. All uses of this material should be consistent with FDA, USDA, 

and EPA labels and regulations and utilize personal protective equipment as needed.

Discussion:

Peracetic acid has been relisted each time it was reviewed during the sunset review process. There has 

been strong support for continued availability of this material. Oral and written comments submitted for 

the Spring 2019 NOSB meeting represent hundreds if not thousands of crop and livestock farmers and 

processors who uniformly support relisting this essential and relatively safe material. In particular, many 

processors identified the need for a “no-rinse” material as essential for treating equipment and other 

food contact surfaces. Overall, this material is considered effective and offers a less toxic profile then 

several other sanitizing materials, including many chlorine compounds. The TR does not offer new 

evidence of unacceptable adverse impacts on human health or the environment. During the last review, 

use of a synthetic stabilizer such as 1-hydroxyethylidene-1,1- diphosphonic acid (HEDP) or 2,6-

pyridinedicarboxylic (dipicolinic) acid to slow the rate of oxidation or decomposition were judged to be 

“inerts” for EPA registration as an antimicrobial and not subject to review as an ancillary substance. 

NOSB October 2019 proposals and discussion documents Page 41 of 230
However, comments submitted for the Spring 2019 meeting that at least “dipicolinic acid is a former List 

3 “inert” and not allowed in products used in organic production” and identifies additional “inert” 

materials that warrant review. Only products with allowable “inert” ingredients should be used.

Additional information requested by subcommittee: None

Subcommittee Vote: 

Motion to remove peracetic acid from 205.605(b) of the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Asa Bradman

Seconded by: Steve Ela

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

Potassium citrate

§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)).”

Reference: 205.605(b) Synthetics allowed: Potassium citrate. 

Technical Report: 1995 TAP; 2015 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Uses: Antioxidant, acidulant, pH control, flavoring agent, sequestrant, emulsifying salt, stabilizer, and as a 

dispersant in flavor or color additives. Commonly used in biscuits, baby food, soup mixes, soft drinks, and 

fermented meat products. It is also used to wash processing equipment to remove off flavors.

Potassium citrate is used to replaced sodium citrate whenever a low sodium content is desired. 

Manufacture:

Potassium citrate is the potassium salt of citric acid. It is prepared by neutralizing citric acid with potassium 

hydroxide or potassium carbonate and subsequent crystallization. 

Potassium citrate is Generally Recognized as Safe (GRAS) as listed under 21 CFR 184.1625. 

International:

Allowed by Canada and International Federation of Organic Agriculture Movements (IFOAM) (allowed as an 

additive). 

Ancillary substances: 

According to the 2015 TR, citric acid and its salts (including calcium citrate) are commercially supplied as 

pure compounds and do not contain ancillary substances. 

NOSB October 2019 proposals and discussion documents Page 42 of 230
Discussion:

According to the 2015 TR, based on various toxicology studies, citric acid and its salts (including potassium 

citrate) are not expected to pose any significant health hazard upon ingestion. The manufacture of 

potassium citrate was not addressed in terms of potential harm to the environment. 

The TR cited the versatility of citric acid and its salts as the reason why no alternative practices could be 

used to substitute for all functions they provide. Additionally, there are no nonsynthetic sources or 

alternatives for the citrate salts.

2019 spring public comment was supportive and mentioned uses including: acidity regulator in the wine 

making process; buffer in confectionary products; when combined with citric acid the pair provides tartness 

without a significant drop in pH which is important in preventing the degradation of sucrose in 

confectionary products and for achieving consistent pH for the gelling on pectin; offers an advantage over 

sodium citrate in that it does not add additional sodium to the product. One commenter would like to see 

all the citrates be restricted to uses that are in compliant with 205.600(b)(4), however that restriction only 

applies to processing aid and adjuvants.

No new information was brought forward in terms of harm to human health or the environment. 

Additional information requested by subcommittee: None

Subcommittee Vote:

Motion to remove potassium citrate based on the following criteria in the Organic Foods Production Act 

(OFPA) and/or 7 CFR 205.605(b) if applicable: NA

Motion by: Lisa de Lima

Seconded by: Asa Bradman 

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

Potassium phosphate

§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)).”

Reference: 205.605(b) Synthetics allowed: Potassium phosphate—for use only in agricultural products 

labeled “made with organic (specific ingredients or food group(s)),” prohibited in agricultural products 

labeled “organic”. 

Technical Report: 1995 TAP, 2016 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Uses: 

Potassium phosphate can be used as a pH control in milk and dairy products, to make acidified milk 

products and in milk protein stabilization. It can also be used as a nutritional additive for a source of 

potassium and as a nutrient in yeast. Potassium phosphate can also be used in prepared meat applications 

NOSB October 2019 proposals and discussion documents Page 43 of 230
and liquid eggs. The initial Technical Advisory Panel report (TAP) included a recommendation to list this 

material as an approved synthetic in products labeled “organic,” but was only approved for use in “made 

with” products. 

Manufacture: 

The initial TAP noted potassium phosphates are isolated from brines or salt deposits. However, the 2015 

TR explained the manufacturing process to be as follows: All of the orthophosphate derivatives of 

potassium can be generated by neutralization of phosphoric acid with potassium hydroxide (Budavari 

1996). Phosphoric acid is produced by treating phosphate rock (tricalcium phosphate) with sulfuric acid, 

forming phosphoric acid and calcium sulfate (Budavari 1996). Potassium hydroxide is obtained 

commercially from the electrolysis of potassium chloride solution in the presence of a porous diaphragm. 

[21 CFR 184.1631]. (2015 TR, pg 30-31)

International: 

Potassium phosphate is not listed in CODEX, does not appear on the EU, JAS or IFOAM organic standards, 

but is listed in the Canadian organic standard for products in the 70%-95% category only.

Discussion: 

During the 2017 sunset cycle public comment was received in support of potassium phosphate noting it is 

an efficient pH buffering substance with no organic alternatives. The industry indicated that potassium 

phosphate is used in non-dairy beverages; that it prevents precipitation and impaired mouthfeel; that the 

alternatives are not as good; and loss of this product would mean impaired quality and marketability. Other 

commenters noted a concern with the use of phosphates in production of processed foods and that 

phosphorus may not appear on the nutritional panel making it difficult to be informed about total 

phosphorous intake– although they would appear on the ingredient list. In particular there were concerns 

raised about the cumulative health impacts of phosphorous additives in food and in 2015 the NOSB 

requested a technical review and work agenda item to study this issue further. Concerns were based on 

peer reviewed research indicating that the cumulative effects of phosphates as a group contributing to 

renal damage and failure, osteoporosis, and heart failure. A brief literature review shows clinical research 

from 2010 (Journal of Kidney Disease: April 2010 4(2):89-100), and 2013 (Sim et al, American Journal of 

Medicine, January 2013) suggesting potential serious renal impacts in subjects with normal renal function, 

from cumulative phosphorus. A daily limit of 70 mg/kg/day was recommended in one study. Populations at 

risk for bone health and kidney failure were especially impacted. In 2016 the NOSB Handling 

Subcommittee published a discussion document on the cumulative health impacts of phosphates and the 

NOSB decided to address phosphates individually during sunset reviews. Sodium phosphate was reviewed 

in 2017 and the NOSB came to the following conclusion:

No single phosphate food additive or ingredient can be implicated as an isolated risk factor. 

Concerns arise from the increase in cumulative use of phosphates and possible health effects on 

the general population. Given the new information and research since last Sunset Review, the 

Handling Subcommittee requested a new Technical Report (TR) which it received in 2016. The TR 

indicates that small amounts of sodium phosphates may not cause human health problems, but 

long-term cumulative impacts are not fully understood.

During the 2019 public comment period we posed the following questions: Does industry still find the 

listing for potassium phosphate necessary – in what applications is this substance currently be used in 

products being marketed as “made with organic.”; and if applications are for nutritional supplementation 

only – is this substance redundant to the current Nutrient Vitamin and Mineral listing? If yes, should this 

listing be removed? 

We heard from a certifier that noted at least 2 operations were using potassium phosphate for fortification 

purposes. Comments were also received from an industry trade association about the various possible uses 

NOSB October 2019 proposals and discussion documents Page 44 of 230
of phosphates and responses to the long term exposure risks to human health of phosphate products in 

general. It was not clear their comments were specifically about applications of phosphates in organic 

certified products. There was some support for removing this listing as redundant to the Nutrient Vitamins 

and Minerals listing but there was also opposition to the group listing of vitamins and minerals. 

No new information was received by the NOSB supporting removal of this substance. 

Subcommittee Vote: 

Motion to remove potassium phosphate from §205.605(b) of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Tom Chapman

Seconded by: Steve Ela

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

Sodium acid pyrophosphate

§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)).”

Reference: 205.605(b) Synthetics allowed: Sodium acid pyrophosphate (CAS # 7758-16-9)—for use only as 

a leavening agent.

Technical Report: 2001 TAP (Sodium Phosphates); 2010 TR; 2016 TR

Petition(s): 10/2002 petition; 03/2007 petition for expand use

Past NOSB Actions: 05/2003 sunset recommendation; 11/2009 sunset recommendation; 04/2011 sunset 

recommendation

Regulatory Background: Added to National List 09/12/06 (71 FR 53299); Renewed 8/03/2011 (76 FR 

46595); Renewed 09/12/16 (81 FR 8821)

Sunset Date: 9/12/2021

Subcommittee Review: 

Uses

Sodium acid pyrophosphate is a common food additive for the purpose of a sequestrant/chelating agent in 

processed potatoes, an emulsifying agent in cheese, an inhibitor agent in canned tuna, and a curing 

accelerator in processed meats. This listing limits its use as a leavening agent. Sodium acid pyrophosphate is 

used as a leavening agent in baked goods, where it reacts with baking soda (sodium bicarbonate) to liberate 

carbon dioxide, ‘leavening’ the dough and creating the desired ‘airy’ texture that consumers expect of 

baked goods such as cakes and cookies. It is GRAS, listed at 21 CFR 182.1087.

Manufacture

Sodium carbonate is reacted with phosphoric acid to form monosodium phosphate, followed by heating 

the monosodium carbonate to 220oC to form sodium acid pyrophosphate. It is expressed by the formula 

Na2H2P2O7 and is composed of 20.72% Na, 0.91% H, 27.91% P, and 50.46% O. Sodium is isolated from 

brines or salt deposits. Phosphorous is isolated from phosphate rock. Food grade phosphates are formed by 

reacting purified phosphoric acid with sodium, potassium, or calcium hydroxides.

International

The Canadian General Standards Board Permitted Substances List (CAN/CGSB 32.311-2006) permits these 

phosphate salts with usage annotations identical to the NOP regulations.

CODEX Alimentarius Commission Guidelines for the Production, Processing, Labelling and Marketing

NOSB October 2019 proposals and discussion documents Page 45 of 230
of Organically Produced Foods (GL 32-1999)

These guidelines only permit monocalcium phosphate (341(i)) and “only for raising flour” (as a leavening 

agent).

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

ANNEX VIII, Certain products and substances for use in production of processed organic food referred to in 

Article 27(1)(a), Section A – Food Additives, including Carriers, lists only monocalcium phosphate (341(i)) as 

a “Raising agent for self-rising flour” (as a leavening agent).

Japanese Agricultural Standard for Organic Processed Foods (Notification No. 1606 of the Ministry of

Agriculture, Forestry and Fisheries of October 27, 2005)

Table 1, “Food Additives,” lists INS 341(i), Calcium dihydrogen phosphate (a.k.a. monocalcium phosphate), 

with the annotation “Limited to be used for powders as expanding agent” (as a leavening agent).

IFOAM – Organics International (IFOAM)

The IFOAM norms for Organic Production and Processing, Version 2014, list monocalcium phosphate, INS 

341, as a food additive “Only for ‘raising flour’” (as a leavening agent).

Ancillary Substances

None identified.

Discussion

During the last sunset review, this material received positive support from stakeholders. While excess 

phosphates in wastewater contributed to environmental degradation in the past, this was largely due to its 

use in detergents. Its use in detergents has waned and in this use as a food additive, phosphates would 

have little environmental impact.

The 2016 technical report (TR) on phosphates includes extensive discussion on the impact of phosphorous 

on the human diet, with particular focus on health effects of phosphorous provided by phosphate additives 

versus natural phosphorous in foods. Added phosphorous, as is found in sodium acid pyrophosphate, is 

immediately and completely bioavailable upon consumption whereas “food” phosphorous is much less 

available.

High blood phosphate levels are associated with kidney and vascular disease. A sufficiently high intake of 

calcium appears to counteract some of the ill effects of excess dietary phosphorus but leads to an increased 

requirement for magnesium. Due to the restrictions on phosphate use in organic foods, it would be 

expected that basing a diet on organic foods would reduce phosphorus intake.

Yeast, a natural leavener used for time immemorial, is a common alternative to chemical leavening. 

However, yeast leavened baked goods have a different physical texture and require more time than 

chemically-leavened foods. Chemical leavening is used instead of yeast for products where fermentation 

flavors would be undesirable or where the batter lacks the elastic structure to hold gas bubbles for more 

than a few minutes such as found with muffins, pancakes and cookies.

During the first round of comments in the Spring of 2019, a number of food manufacturers and trade 

groups noted the essentiality of this material as it is the only chemical leavener available to the baking 

sector. One organization does not support relisting as the focus of the TR is on negative human health and 

environment effects is on the final product and not the primary manufacture of phosphoric acid.

NOSB October 2019 proposals and discussion documents Page 46 of 230
Subcommittee Vote: 

Motion to remove sodium acid pyrophosphate from §205.605(b) of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Scott Rice

Seconded by: Steve Ela

Yes: 0 No: 4 Abstain: 1 Absent: 2 Recuse: 0

Sodium citrate

§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)).”

Reference: 205.605(b) Synthetics allowed: Sodium citrate.

Technical Report: 1995 TAP; 2015 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review:

Uses: 

Acidulant, pH control, flavoring agent, sequestrant, and buffering agent. Used as an emulsifier in dairy 

products to keep fats from separating, and in cheese making where it allows the cheeses to melt without 

becoming greasy. Also used as dispersants in flavor or color additives, and to wash processing equipment in 

order to eliminate off flavors. 

During the last review of sodium citrate in 2015, public comment included these specific reasons for use: 

• Potassium citrate is an option, but it has an unpleasant metallic taste. Sodium phosphates are another 

option, but they need to be used in higher quantities and are not as effective. 

• We use sodium citrate as part of the process of preparing fresh fruit for use in our yogurts. We use 

sodium citrate primarily for its ability to buffer pH, neither citric acid nor potassium citrate would have 

the same buffering effect in our products.

• Sodium citrate is used in a personal care product (lubricant).

Manufacture:

Sodium citrate is the sodium salt of citric acid. It is prepared by neutralizing citric acid with sodium 

hydroxide or sodium carbonate and subsequent crystallization.

Sodium citrate is listed under 21 CFR 184.1751 as Generally Recognized as Safe (GRAS). The listing allows its 

production from citric acid and sodium hydroxide or sodium carbonate. It is allowed as an ingredient used 

in food with no limitation other than current good manufacturing practice. 

The EPA lists citric acid and its salts in the 2004 List 4A (minimal risk inerts). 

International: 

Canada: Sodium citrate is allowed but restricted to use with sausages or milk products. 

NOSB October 2019 proposals and discussion documents Page 47 of 230
CODEX Alimentarius Commission: Sodium citrate is listed for sausages/pasteurization of egg whites/milk 

products. 

European Economic Community (EEC): Sodium citrate is allowed as an ingredient in the preparation of 

foods of animal origin. 

Japan Agricultural Standard (JAS): Sodium citrate is allowed, but limited to use for dairy products, or for 

albumen and sausage as low temperature pasteurization. 

International Federation of Organic Agriculture Movements (IFOAM): allowed as an additive. 

Ancillary substances: 

According to the 2015 TR, citric acid and its salts (including calcium citrate) are commercially supplied as 

pure compounds and do not contain ancillary substances. 

Discussion: 

According to the 2015 TR, based on various toxicology studies, citric acid and its salts (including sodium 

citrate) are not expected to pose any significant health hazard upon ingestion. The manufacture of sodium 

citrate was not addressed in terms of potential harm to the environment. 

The TR cited the versatility of citric acid and its salts as the reason why no alternative practices could be 

used to substitute for all functions they provide. Additionally, there are no nonsynthetic sources or 

alternatives for the citrate salts.

2019 spring public comment was supportive and mentioned uses including: antioxidant, stabilizing salt, 

buffer, and when combined with citric acid the pair provides tartness without a significant drop in pH which 

is important for preventing degradation of sucrose in confectionary products and for achieving a consistent 

pH for the gelling of pectin. It’s part of process of preparing fresh fruits for yogurt, neither citric acid or 

potassium citrate wouldn't have the same buffering affect. It’s also found in Organic System Plans (OSPs) 

used for meat processing and in manufacturing dietary supplements and personal care products. One 

commenter would like to see all the citrates be restricted to uses that are compliant with 205.600(b)(4), 

however that restriction only applies to processing aids and adjuvants.

No new information was brought forward in terms of harm to human health or the environment. 

Additional information requested by subcommittee: None

 

Subcommittee Vote:

Motion to remove sodium citrate based on the following criteria in the Organic Foods Production Act 

(OFPA) and/or 7 CFR 205.605(b) if applicable: NA

Motion by: Lisa de Lima

Seconded by: Harriet Behar 

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

NOSB October 2019 proposals and discussion documents Page 48 of 230
Tocopherols

§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)).”

Reference: 205.605(b) Synthetics allowed: Tocopherols—derived from vegetable oil when rosemary 

extracts are not a suitable alternative.

Technical Report: 1995 TAP; 2015 limited scope TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2011 sunset 

recommendation; 10/2015 NOSB Final Review; 09/2016 Handling Subcommittee proposal additional listing 

of Tocopherol

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use:

Synthetic tocopherols are currently permitted for use in organic agriculture handling/processing as an 

antioxidant ingredient in foods (2015 TR). Tocopherols are added to foods to help prevent oxidation of the 

fatty acids present in the lipid components of the food. Tocopherols derived from vegetable oil are allowed 

for use as ingredients in or on processed products labeled as “organic” or “made with organic (specified 

ingredients or food group[s])” when rosemary extracts are not a suitable alternative (7 CFR 205.605[b]).

Manufacture:

Tocopherols are a group of lipophilic phenolic antioxidants that occur naturally in a variety of plant

species. Sources of naturally-occurring tocopherols include cereal grains, oilseeds, nuts, and vegetables. 

As described in the 2015 TR, tocopherols are separated from the other compounds in the oil distillate by 

multiple extraction and refining steps. These steps can include solvent extraction, chemical treatment, 

crystallization, complexation, and vacuum or molecular distillation. The total tocopherol content of the 

resulting product is usually 30 - 80%. Liquid forms of mixed tocopherols are commercially available 

diluted in vegetable oils and are also available as mixtures with rosemary extracts, ascorbyl 

palmitate/ascorbic acid, lecithin and/or citric acid. Powdered forms of tocopherols are produced by 

spray-drying the liquid tocopherol oils onto a carrier or mixture of carriers.

International:

Japan: Listed for processed meats. 

Codex: Allowed.

Canada: Allowed 

IFOAM: Allowed

European Union: Allowed

Ancillary Substances:

Table 1 from the most recent technical review (TR) shows some of the more common formulations 

along with their ancillary substances.

NOSB October 2019 proposals and discussion documents Page 49 of 230
Discussion:

The NOSB has consistently relisted this material due to its essentiality for many processed food 

products. However, there has been extensive discussion about the need for synthetically derived 

tocopherols. Public comment has historically been divided on the relisting due to concerns that the

NOSB October 2019 proposals and discussion documents Page 50 of 230
material’s primary use is as a preservative and therefore inconsistent with organic production. 

Additionally, commenters have asserted that non-synthetic tocopherols are commercially available 

and should be used instead of synthetic. However, many past commenters have expressed strong 

support of relisting, stating that tocopherols are critically essential to maintaining food safety, 

preventing rancidity, and providing nutrients to their products, and that rosemary oil imparted off 

flavors or fragrances to their products that were not acceptable to consumers. Many comments were 

submitted during the April 2019 meeting and were uniformly supportive of relisting this material, 

including assertions that adequate non-synthetic sources were not available or that rosemary or other 

derived tocopherol product were not adequate. One comment recommended that the Handling 

Subcommittee investigate the availability of natural tocopherols manufactured without solvents, and, 

depending on availability, that they be removed from §205.605(b) and petitioned for §205.605(a). The 

Handling Subcommittee considered the possibility of reclassifying tocopherols to 205.605(a), or listing 

on both 205.605(a) and 205.605(b) with different uses annotated for each listing and/or an annotation 

about availability; however, as discussed at the Fall 2017 meeting, the Handling Subcommittee 

concluded to not move forward with the tocopherol annotation change. The meeting transcripts note 

that “if there is sufficient commercial availability of this material in another form, we encourage 

members of the public or industry to petition the NOSB to make this change, and we would take it up 

at that time”.

Human Health and the Environment:

Tocopherols are one of the main sources of Vitamin E. No major impacts on human health or the 

environment are likely.

Additional information requested by Subcommittee: None

Subcommittee Vote: 

Motion to remove tocopherols from §205.605(b) of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Asa Bradman

Seconded by: Steve Ela

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

NOSB October 2019 proposals and discussion documents Page 51 of 230
Reference: 7 CFR §205.606

Celery powder

§205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed 

products labeled as “organic.”

Reference: 205.606(c) Celery powder. 

Technical Report: N/A

Petition(s): 2007 Petition

 Past NOSB Actions: 03/2007 NOSB recommendation; 04/2010 sunset recommendation; 10/2015 NOSB Final 

Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review:

Use:

Meat preservation via natural nitrites/lactic acid is an ancient technology. In the organic sector, celery 

powder is used in a variety of processed meat products (hot dogs, bacon, ham, corned beef, pastrami, 

pepperoni, salami, etc.) to provide “cured” meat attributes without using prohibited nitrites. Celery 

powder is naturally high in nitrates that are converted to nitrites during fermentation by a lactic acid 

culture. Celery powder and the presence of nitrate and nitrites protects against spoilage (as an 

antioxidant) and also reduces risk from food borne pathogens, including clostridium botulinum, which 

produces botulin toxin. Celery powder is used in place of synthetic chemical nitrate and nitrite which are 

not currently permitted in U.S. organic agriculture. Although functionally similar to the use of synthetic 

nitrate and nitrite, meat products processed with celery powder must be labeled “uncured.”

Manufacture:

Celery is cleaned, macerated, physically separated (liquid/solid), and the liquid is concentrated by 

evaporation, then heated and vacuum dried. According to the original petition, 0.2-0.5% celery powder 

and 0.01-0.5% of lactic acid starter culture are used to convert the nitrates to nitrite and thus create the 

curing agent. According to the Kerry Inc. patent 

(https://patentimages.storage.googleapis.com/1b/75/a5/082eb2538620f2/US20080305213A1.pdf), “the 

curing agent can further comprise additional components, including but not limited to, yeast extract, 

protein hydrolyzates, amino acids, vitamins, minerals, and carbohydrates. Prior to the conversion of 

nitrate to nitrite, the pH and salt content of the plant material can be adjusted with the addition of a 

suitable acid, base, salt, or combination thereof. The plant material can be subjected to additional 

processing steps prior to conversion of nitrate to nitrite. Such processing steps can include, but are not 

limited to, heat treatment, filter sterilization, or a process which reduces the initial microbial load.” Celery 

powder is typically standardized to a specific nitrite content. See discussion below for more information 

about source material.

International:

There is no list of individual non-organic agricultural commodities allowed under the Japanese Agricultural 

Standards (JAS), International Federation of Organic Agricultural Movements (IFOAM) or Codex standards 

– however these standards allow for up to 5% non-organic content. Celery powder is not listed in the EU 

Organic Standards; however, sodium nitrate is allowed for meat products (an alternative to celery powder 

not currently listed on the National List).

NOSB October 2019 proposals and discussion documents Page 52 of 230
Ancillary substances:

Possibly materials listed in the patent: “including but not limited to, yeast extract, protein hydrolyzates, 

amino acids, vitamins, minerals, and carbohydrates.”

Human Health and the Environment

Nonorganic celery is used to produce celery powder, with concomitant use of allowed conventional 

pesticides and fertilizers. These materials may pose risks to workers, consumers and the environment. 

Additionally, health concerns have been raised about the use of synthetic nitrates and nitrites in 

processed meats (allowed in the European Union). For example, the International Association for 

Research in Cancer (IARC) listed processed meats as carcinogenic to humans due to the formation of 

nitrosamines, albeit with low potency, and the review committee was not unanimous. In terms of 

human health risks from nitrates/nitrites in food, there is no difference between celery or other plantbased nitrate sources versus synthetic nitrates and nitrites used on non-organic meats. In summary, 

nitrates and nitrites from celery powder would pose similar risks. Nitrates in food may provide some 

health benefits. For example, formation of nitrous oxide may result in lowered blood pressure and 

better cardiovascular function.

Discussion (including OFPA criteria):

Celery powder was listed as a nonorganic handling material in response to a 2007 petition asserting the 

need for a uniform, agriculturally produced material necessary to produce organic processed meats such 

as bacon, hot dogs, and sausage. Several commenters argue that this material allowed substantial growth 

of the organic meat industry while complying with the “organic” or “made with organic” claims of 

processed foods. However, concerns were, and continue to be, raised about the direct dependence on a 

conventionally grown agricultural product in organic trade and concomitant impacts on human health and 

the environment. Particular concerns have been raised about the possibility of enhanced use of nitrate 

fertilizers to “supercharge” the product used for celery powder manufacture.

In lieu of a technical report, a celery powder expert panel was convened for the April 2019 NOSB meeting. 

Experts spoke to key questions addressing nitrate safety, organic celery powder production, processing 

and manufacture of celery powder, progress toward organically sources celery or other substrates that 

could be used process organic meats, and the scale of the organic processed meat industry. Presentations 

and discussion addressed concerns raised during past reviews that production of high nitrate conventional 

nonorganic celery used for celery powder production requires enhanced use of synthetic nitrate 

fertilizers. In summary:

• Celery powder remains an essential curing agent for organic cured meats. Alternative source 

material such as swiss chard or other crops do not fill the need for a uniform product;

• Currently, celery powder is the only option available to comply with FSIS food safety requirements;

• Organic cured meat products represent a multi-million dollar industry and have increased 

opportunities for organic agricultural production; 

• Because celery powder is used in small amounts, it is difficult to leverage investment to develop 

alternative sources;

• In various trials, nitrate levels in organically produced celery were ~1,000 ppm and ranged from ~500 

to ~2000, but there was very high variability between varieties, farms, and years. Overall, organic 

levels were not uniform and generally below thresholds needed for meat processing;

• Nitrate levels in mature conventional celery were much higher – in the range of ~2500 ppm;

• No information was available as to whether agronomic methods to produce conventional celery for 

celery powder production entailed the use of extra nitrate use;

• More research is needed to identify varieties and methods to produce organically produced celery 

NOSB October 2019 proposals and discussion documents Page 53 of 230
powder source material.

Overall, trade and industry members of the organic community supported relisting of celery powder at 

§205.606, with the caveat that more research is needed to produce a viable organic alternative. There 

was little opposition to relisting celery powder except one consumer group that reflected concerns about 

the direct dependence of the large organic processed meat industry on a conventionally grown 

agricultural product and whether its use is a direct violation of OFPA and organic regulations and 

artificially adding nitrate as a preservative at levels not possible to achieve through use of organic celery. 

Concerns were raised about the cancer health risks of nitrates and nitrites, but as noted above there are 

also potential health benefits to nitrate intake. Given the importance of the organic processed meat

industry, public and NOSB comments encouraged the USDA to fund additional research to develop 

organic alternatives to conventionally produced celery powder. 

Additional information requested by Subcommittee: None

Subcommittee Vote: 

Motion to remove celery powder from the National List at §205.606(c) based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Asa Bradman

Seconded by: Scott Rice 

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

Fish oil

§205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed 

products labeled as “organic.”

Reference: 205.606(e) 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.

Technical Report: 2015 TR

Petition(s): 2007 Petition

Past NOSB Actions: 03/2007 sunset recommendation; 04/2010 sunset recommendation ; 10/2015 NOSB 

Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Section 205.606 allows for use of non-organically produced ingredients to be used in processed products 

labeled “organic” when the ingredient is not commercially available in organic form. 

 

The NOP does not presently have production standards for aquaculture, therefore organic fish cannot be 

commercially available as organic. 

Uses: Fish oil is used in organic processing and handling as an ingredient to increase the content of omega-3 

fatty acids - primarily, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) - in foods to benefit 

human health by contributing to healthy brain development and reducing risks of cardiovascular disease, 

diabetes, inflammation, atherosclerosis (Chang et al., 2009; Lee et al., 2014). Fish oil is used in a variety of 

food products, including breads, pies, cereals, yogurt, cheese products, frozen dairy products, meat 

NOSB October 2019 proposals and discussion documents Page 54 of 230
products, cookies, crackers, snack foods, condiments, sauces, and soup mixes (Rizliya and Mendis, 25 2014). 

(Technical Report 2015 lines 19-25). 

 

In addition to aquaculture - estimated to use about 81% of the fish oil produced worldwide - fish oil is used 

in feed for livestock such as pigs, cattle, poultry, and sheep. Industrial applications of fish oil include paint 

production, leather making, and biodiesel manufacture. 

 

History: Fish oil was added to the National List in 2007, based on a petition from a manufacturer. At that 

time the NOSB did not request a technical report (TR) or Technical Advisory Panel Report (TAP). The NOSB 

2007 recommendation indicated that the OFPA criteria were met in all categories but provided no scientific 

rationale or citations to support such findings. However, the NOSB final recommendation from May 9, 2007 

stated ...”pursuant to the judgment in Harvey v. Johanns, the NOSB was instructed to develop criteria for 

determining commercial availability, an essential tool in evaluating whether or not petitioned materials 

could be listed at § 205.606. These criteria were finalized in the NOSB “Recommendation for the 

Establishment of Commercial Availability Criteria National List § 205.606” of October 19, 2006. “That 

recommendation allows for pro-active listing on § 205.606 of materials that may currently be available in 

an organic form, but the supply of which has a history of fragility due to factors such as limited growing 

regions, weather, or trade-related issues. Furthermore, the recommendation reiterates the role of the 

Accredited Certifying Agent (ACA) in making the ultimate decision as to whether a § 205.606-listed material 

may be used, on a case by case basis. ...” “.... After discussion, the Board decided to add an annotation to 

the recommendation to list fish oil to the National List. The annotation is “stabilized using only allowed 

ingredients on the National List.” The Board felt that this annotation was not overly prescriptive since a 

nonorganic material that falls within the annotation exists on the market.” The NOSB (2007) further noted 

that “There were no public comments specifically opposing the listing of fish oil on §205.606....” 

In its five-year review in April 2010 the NOSB received no public comment and fish oil remained on the List. 

In February 2015 the NOSB posed the following questions in the first posting of this material under the new 

Sunset procedure: 

1. What are the primary geographic sources of fish oil and primary fish species harvested for the purpose of 

 oil extraction? 

2. Are there conservation and environmental issues surrounding harvest of wild caught fish for fish oil? 

3. What is the manufacturing and purification process? 

4. Is there a mandatory standard for fish oil purity with limits on contaminants, dioxins and PCB’s for 

 example? How is purity assessed? 

5. Is the Voluntary Standard from the Council of Responsible Nutrition (CRN) for contaminant limits still in 

 effect? 

6. What is the most current research on plant-derived alternatives such as flax and chia and how 

comparable 

 are they to the Omega 3 in fish and algal oils? 

In addition, in preparing for the 2017 Sunset Review the NOSB requested a full TR which was received in 

March 2015 after the posting of the initial sunset review. The 2015 TR provides a valuable in-depth analysis 

and provides up-to-date research and citations allowing the Subcommittee to re-evaluate fish oil 

comprehensively against the OFPA criteria. Sources: Fish oil is derived from a wide range of wild caught fish 

species including, tuna, mackerel, sardines, anchovy, halibut, (TR lines 69-79). NOTE: The TR also lists fish oil 

from whales and seal under fish, although these are mammals. (TR lines 75-76). 

Fish oil is produced from fish by-products or from fish that are caught specifically for the purpose of making 

fish oil (TR lines 283-284). Farmed fish are not a source of fish oil; they are often fed fish oil supplements to 

boost their own levels of omega 3 fatty acids (TR 332-333). Based on 2009 data from the 2010 

International Fishmeal and Fish Oil Organization (IFFO) Fishmeal and Fish Oil Statistical Yearbook, Peru 

NOSB October 2019 proposals and discussion documents Page 55 of 230
produces the most fish oil worldwide and is responsible for one-third of the global production of fish oil, 

followed by Chile and the United States (Fréon et al., 2014; SEAFISH, 2011). Denmark, Japan, and Iceland 

are also prominent producers of fish oil. Overall, Peru is the world’s largest exporter of fish oil; together, 

Peru and Chile are responsible for 39% of global fish oil exports Most of the fish oil produced in Peru and 

Chile is refined by companies in Norway, the United States, and Canada although domestic refineries for 

fish oil are emerging in Peru, Chile, and other South American countries (Dowling, 2012; GOED, 2014). (TR 

90-110) 

Manufacturing: Fish oil remains intact through the purification process and is not chemically modified (TR 

338). Fish oil used for feed, aquaculture, supplements, or food applications is further purified using a 

carbon filter to reduce contaminants (e.g., dioxins/furans, polybrominated diphenyl ethers [PBDEs], 

polychlorinated biphenyl [PCBs], polycyclic aromatic hydrocarbons [PAHs]) that may be present in the oil 

(Rizliya and Mendis, 2014). Further extraction and purification of the oil can be performed by selective 

hydrolysis, followed by filtration, neutralization with sodium hydroxide, removal of oxidized oil by clay, and 

deodorization using steam distillation (EPAX Norway, undated; U.S. FDA, 2002) (TR 307320). There are also 

other purification methods, which are discussed in the TR. 

International: Fish oil is not listed as allowed for organic processing in Canada, Japan, EU, or under IFOAM 

and is not listed in CODEX (TR 245-275). However, it should be noted that CODEX, IFOAM and JAS do not 

have discreet lists for non-organic agricultural substances. The EU does have a positive list and it does not 

list fish oil, but the EU Organic Standards also allow for organic certification of aquaculture. There are EU 

organic fish oil products being sold. 

Discussion: Human Health: Fish oil is a naturally sourced product which appears to provide a multitude of 

health benefits (as listed above under “Uses”). It is one of the best sources of Omega 3 EPA and DHA fatty 

acids. Fish oil such as cod liver oil which has been given to children in many areas of the world for 

generations to promote healthy brain development and prevent inflammation. Fish oils are added to many 

foods and taken as dietary food supplements to promote heart health and reduce risk of atherosclerosis. 

However, the health benefits from consumption of fish oil is currently a debated topic in the scientific 

community (TR 471) and some sources suggest that there are health risks from fish consumption that 

may outweigh the benefit of omega 3 fatty acids from fish oil (TR 489-494). However, this statement is 

contradicted by the FDA’s A Quantitative Assessment of the Net Effects on Fetal Neurodevelopment 

from Eating Commercial Fish, which states “the assessment estimates that for each of the endpoints 

modeled, consumption of commercial fish during pregnancy is net beneficial for most children in the 

United States.”2 Fish bioaccumulate many contaminants (TR 503-507). A laboratory analysis of 31 fish 

oil supplements found that every product contained measurable amounts of mercury, with an average 

concentration of 2.9 parts per billion (ppb) across all brands (TR 403-408, LabDoor, 2014). The highest level 

of mercury recorded in the supplements was 6 ppb (LabDoor, 2014). It should be noted however, that these 

tests were on fish oil supplements, not on fish oil used in food products which is controlled under different 

regulations than dietary supplements. The FDA action level for methylmercury in fish is 1 part per million 

(ppm) (U.S. FDA, 2011). The Global Organization for and DHA Omega-3 (GOED) sets voluntary standards for 

fish oil. GOED recommends a maximum value of 0.1 mg/kg (i.e., 0.1 ppm or 100 ppb) mercury in fish oil. 

The GOED has set the same 0.1-ppm voluntary standard value for lead, cadmium, and inorganic arsenic 

(GOED, 2012). 

PCBs might also be present in fish oil. The levels of PCBs and other lipophilic organochlorine chemicals will 

be more concentrated in the oil fraction of the fish than in the whole fish (U.S. FDA, 2011). The FDA 

tolerance for PCBs is 2 ppm for all fish (U.S. FDA, 2011). An analysis of 13 over-the-counter children’s fish oil 

2 https://www.fda.gov/media/88491/download

NOSB October 2019 proposals and discussion documents Page 56 of 230
dietary supplements showed that every supplement contained PCBs, with a mean concentration of 9 (± 415 

8) ppb (TR 413-415, Ashley et al., 2013). The GOED maximum value for PCBs in fish oil is 0.09 ppm (GOED, 

2012). Dioxins and furans are hazardous environmental compounds that may also be found in fish and fish 

oil. In one study, 30 samples of omega-3-enriched dietary supplements were analyzed for the presence of 

dioxins/furans and PBDEs. Twenty-four of the samples had dioxin levels above detection, while all samples 

had PBDE levels above detection. Average intake estimates for dioxins and PBDE’s from the supplements 

were 4.3 picograms (pg) and 25,100 pg per day, respectively (Rawn et al., 2009). 

The GOED maximum values for dioxins; dioxin-like PCBs; and total dioxins, furans, and dioxin like PCBs are 2 

pg, 3 pg, and 4 pg, respectively (GOED, 2012). There are no FDA action levels for dioxins and PBDEs, nor are 

their guidance levels of these compounds in supplements. (TR 404-426). Note: The TR addresses the 

February 2015 NOSB Questions 1, 2, 3 and 6 listed above under History, and partially answers Question 4, 

but it is not clear if the Voluntary Standard for contaminant limits is still in effect (Question 5). 

Conservation issues: There is a very high demand for fish oil. 81% of fish oil goes to aquaculture. Demands 

on fisheries may overburden the current supply of fish (TR 441-450). Fish oil used is from wild caught and 

not farmed fish. Overfishing may also lead to species extinctions and a decrease in biodiversity. There are 

more than 100 confirmed cases of extinctions in marine fish populations worldwide (Jenkins et al., 2009). 

Exploitation of fisheries is the largest contributor to marine extinctions, higher than habitat loss, climate 

change, invasive species, pollution, and disease (Dulvy et al., 2003) (TR 462-465). While some countries 

have highly regulated fisheries to prevent overfishing, many do not. According the Food and Agriculture 

Organization’s (FAO) State of the World’s Fisheries and Aquaculture, most of the pelagic fish stocks, 

globally, are considered either fully fished or overfished. Food and Agriculture Organization of the United 

Nations Fisheries and Aquaculture Department (2014). The State of the World Fisheries and Aquaculture. 

pp. 39. While many different species are used for fishmeal and fish oil, small pelagics are most commonly 

used due to their high oil content. Peruvian anchoveta, Japanese anchovy, and Atlantic herring are the most 

common pelagic species harvested for fishmeal and fish oil, with primary stocks in the Southeast Pacific, 

Northwest Pacific, and Northeast and Northwest Atlantic, respectively. In 2010, all of these were either fully 

exploited or depleted. (Food and Agriculture Organization of the United Nations Fisheries and Aquaculture 

Department. (2010) The State of the World Fisheries and Aquaculture. pp. 35. Available at: 

http://www.fao.org/docrep/013/i1820e/i1820e.pdf ) 

In the Mediterranean, sardine and anchovy stocks have been assessed as fully fished (FAO 2014, p 40). 

According to FAO, fisheries that target species of a specific trophic level, such as those that target pelagics 

for fishmeal and fish oil production, remove “one ecosystem component without considering cascading 

effects on the dependent species...Concerns about the impacts of harvest strategies that fail to consider 

trophic relationships in a given ecosystem have been recognized for decades, and abundant scientific 

literature exists underpinning its possible negative impacts on the structure and functioning of aquatic 

ecosystems.” (FAO 2014, p 136). Sardines, anchovies, and herring play a key ecological role in the survival of 

larger predatory fish, mammals, and seabirds, serving as an important link in the transfer of energy from 

plankton to species higher in the marine food web, some of which are endangered (FAO 2014, p 137), such 

as humpback whales. 

There was a divided opinion of the Board and public in the 2015 review of this substances. There was a 

high consumer demand and industry strongly supports continued listing, especially as there are no organic 

sources. Industry comments (April 2015) include the following: “Used in Gummy Confections, Gummy 

Nutritional Supplements, Panned Jelly Beans.... Fish Oil is used in our products as a natural source of DHA. 

An organic form is not available.... No alternative management practices that would eliminate the need for 

the specific substance. This ingredient is essential to our organic products.” Other Industry comments: “Fish 

oil provides nutritional benefits which our consumers are seeking”; “Peru fisheries are well regulated”; 

“specification sheets indicate levels of PCB’s, arsenic, cadmium and lead are tested 3 times a year to meet 

NOSB October 2019 proposals and discussion documents Page 57 of 230
very strict guidelines; plant sources of omega 3 are not as complete as found in fish oil”. On the other 

hand, conservation groups are concerned about impact on word fisheries, and NGO’s are concerned about 

the cumulative risk impact of fish oil on human health recommend removing fish oil as it fails to meet OFPA 

criteria relating to human health, environmental conservation and compatibility with a sustainable system 

of agriculture. Public comment was also received about the essentiality of this substance however, 

essentiality is not a criterion used to review agricultural substances in OFPA/NOP regulations. Essentiality is 

only a criterion applied to synthetic substances, adjuvants, and processing aids. In the end the NOSB voted 

to not remove fish oil and the substance was renewed. 

During the 2019 sunset cycle we posed four questions at the spring meeting:

1. Is there a mandatory standard for fish oil purity with limits on contaminants, dioxins and 

 PCB’s for example? How is purity assessed? 

2. How is industry controlling for the risk of contaminants such as heavy metals and PCBs?

3. Is the Voluntary Standard from the Council of Responsible Nutrition (CRN) for contaminant 

 limits still in effect? 

4. How can the annotation be modified to control for the note conservation concerns?

Public comment indicated there was no mandatory standard for fish oil purity limits but that the GOED, a 

trade association representing the 85-90% of the fish oil industry, requires members to comply with a 

monograph for fish oils. As of this review limits were as follows:

• PCBs: Maximum 0.09 mg/kg

• PCDDs and PCDFs: Maximum 1.75 pg WHO-PCDD/F-TEQ/g

• Dioxin-like PCBs: Maximum 3 pg WHO-TEQ/g

• Total Dioxins, Furans and dioxin-like PCBs: Maximum 3 pg WHO-TEQ/g

• Lead (Pb): Less than 0.05 mg/kg

• Cadmium (Cd): Less than 0.1 mg/kg

• Mercury (Hg): Less than 0.1 mg/kg

• In-organic Arsenic (As): Less than 0.1 mg/kg3

The organization states control is established via randomized testing but no details on this program were 

provided. The same organization noted that the CRN monograph and its Omega-3 Working Group were the 

foundations for the GOED trade association. The current GOED monograph is the successor to the CRN 

monograph. 

Support was received from several commenters, including the GOED trade association, for annotations that 

further address conservation concerns. The NOSB has submitted a separate work agenda request on this 

topic, however, annotation changes are handled separately from sunset reviews. 

Support was received from organic dairies and industry that speak to the consumer demand for omega-3 

enriched products and having an opportunity to compete with conventional products that market 

themselves similarly. Opposition was received from several interest groups who questioned the 

environmental impact from overfishing, human health impact from heavy metal exposure, and 

compatibility due to its usage as a supplement. Comments are consistent with previous comments 

received by the Board during earlier reviews and did not provide new information on fish oil. Furthermore, 

there is no relevant criteria in OFPA or the Organic regulations for delisting this material based on its use as 

a nutritional supplement. 

No new information was received by the NOSB supporting removal of this substance. 

3 https://goedomega3.com/storage/app/media/Governance%20docs/goedmonograph2019-03-01-r.pdf.

NOSB October 2019 proposals and discussion documents Page 58 of 230
Subcommittee Vote: 

Motion to remove fish oil from §205.606 of the National List based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Tom Chapman

Seconded by: Scott Rice

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

Gelatin 

§205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed 

products labeled as “organic.”

Reference: 205.606(g) Gelatin (CAS # 9000-70-8).

Technical Report: 2002 TAP; 2019 TR Gelatin, collagen gel, and casings

Petition(s): 2001 Petition ; 2007 Petition

Past NOSB Actions: 05/2002 NOSB Recommendation; 05/2007 Recommendation to add to the national list; 

04/2010 NOSB sunset recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Use: 

Gelatin is used in a wide range of products as a clarification or fining agent in teas, juice, and wine, as a 

stabilizer, texturizer, thickener, and in capsules. It may either be an ingredient or a processing aid in candies 

(gummy bears), desserts (puddings, jello, marshmallows), dairy products (yogurt, sour cream, ice cream), 

cereals and cosmetics. Fish gelatin is widely preferred for uses in kosher foods. Collagen gel has recently 

been petitioned for inclusion on the National List at §205.606. Collagen is the native form of gelatin and 

chemically the two are indistinguishable. 

Manufacture:

Gelatin can be made from many different sources of collagen. Cattle bones, hides, pigskin, and fish are the 

principle commercial sources. Gelatin may be prepared in a way that is more like cooking and could be 

considered nonsynthetic. However, gelatin may also be processed in ways that would render it synthetic. 

All manufacturing operations extract and hydrolyze collagen found in fish skins, bovine bone, and porcine 

skin with subsequent purification, concentration, and drying operations. These can be either simple or 

complicated operations.

International: 

EU 2092/91 — Annex VI — Gelatin is listed under “Processing aids and other products which may be used 

for processing of ingredients of agricultural origin” in Section B and under “Ingredients of Agricultural Origin 

Which Have Not Been Produced Organically” in Section C. 

Codex Alimentarius — Guideline for the Production, Processing, Labelling, and Marketing of Organically 

Produced Foods CAC/GL 32-1999, Table 2 Substance for Plant Pest and Disease Control, 1. Plant and 

Animal: listed. Table 4: Listed under “processing aids which may be used for the preparation of products of 

agricultural origin.” 

NOSB October 2019 proposals and discussion documents Page 59 of 230
IFOAM — Basic Standards for Organic Production and Processing, September 2000, Appendix 4 List of 

Approved Ingredients of Non Agricultural Origin and Processing Aids Used in Food Processing, Processing 

Aids and Other Products: listed for use in fruit & vegetable products and wine. 

Ministry of Agricultural, Forestry and Fisheries of Japan (MAFF) — Japan Agricultural Standard, Notification 

#60, Table 2 of food additives: allowed, with no annotation. 

Canada — Canadian General Standards Board National Standard for Organic Agriculture (CAN/CGSB32.310-99), June 1999: permitted as a clarifying agent. 

Certified Organic Associations of British Columbia (COABC) — British Columbia Certified Organic Production 

Operation Policies and Farm Management Standards, Section 9.14 Processing and Handling Materials List, 

March 2001: non hydrolyzed or hydrolyzed, regulated as a processing production aid; Either form of gelatin 

maybe used as a product processing aid, for now, but the producer must submit to the certifying agency 

written details of their search to replace the hydrolyzed gelatin format with a non-hydrolyzed gelatin or a 

completely different product. Allowed for fruits and vegetables and in winemaking.

Naturland, Germany — Listed in the August 1999 General Processing Standards in the “List of Permitted 

Ingredients, Additives, and Auxiliary Products” as “food gelatin without additives (exclusively for cream-like

masses).” 

Ancillary Substances: 

It does not appear that there are any ancillary ingredients used regularly for gelatin, such as anti-caking 

agents, preservatives, colorings etc.

Discussion: 

There are currently no NOP standards for organic aquaculture, and therefore no possibility of obtaining fish 

gelatin in any form, quantity or quality from a certified organic source. Public comment stated concern 

over gelatin sourced from conventional animal sources. The Subcommittee briefly discussed gelatin in 

relation to collagen gel, currently being petitioned, because gelatin is derived from processing collagen. 

During the review period, the Subcommittee posted the following questions:

1) Are there organic sources of collagen that preclude the listing as a non-organically produced 

agricultural product allowed as ingredients in or on processed products labeled as ‘organic’?

2) Are there any ancillary ingredients typically found in commercially available gelatin?

In response to the questions, several commenters said that the organic meat market has not sufficiently 

reached the “magnitude of mass” needed to produce organic gelatin and that the industry is currently 

working on the supply chain for future development of the organic gelatin market. However, detailed 

information about what the barriers are to organic gelatin development were not specified. Several 

commenters mentioned other alternatives to gelatin such as organic pea starch and pectin. However, in 

discussions with organic gummy manufacturers, it was noted that pectin and pea starch may add a flavor 

residue that is undesirable. The 2019 TR did not have any new information indicating that organic gelatin 

would be commercially available in the near future. The Handling Subcommittee hopes that at the next 

sunset review, the barriers to production of organic gelatin will no longer be present.

Subcommittee Vote: 

Motion to remove gelatin from §205.606(f) of the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA 

Motion by: Harriet Behar

Seconded by: Asa Bradman

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

NOSB October 2019 proposals and discussion documents Page 60 of 230
Orange pulp, dried 

§205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed 

products labeled as “organic.”

Reference: 205.606(n) Orange pulp, dried.

Technical Report: N/A

Petition(s): 2008 Petition

Past NOSB Actions: 11/2008 NOSB recommendation for addition to the National List; 10/2015 NOSB Final 

Review

Recent Regulatory Background: Added to NL effective 03/15/2012 (77 FR 8089); Renewed 03/15/2017 (82 

FR 14420)

Sunset Date: 3/15/2022

Subcommittee Review: 

Uses: 

According to the petitioner, dried orange pulp is a fiber with about 33.3% soluble fiber and 34.9% insoluble 

fiber. It is used as a moisture retention agent and fat substitute in baked goods, pastas, salad dressing, 

confectionary, processed cheese spreads, beverages, meat products and frozen foods. Dried orange pulp is 

used in rates up to 5 percent depending on use, but is self-limiting after that point due to loss of desirable 

eating qualities.

Manufacture:

Dried orange pulp is a byproduct of the orange juice industry and is manufactured from the washed orange 

peel, core and rag (membrane) remaining after juicing. The pulp is then mechanically dewatered, stabilized 

with heat, dried, and mill-ground to a powder. The only processing aid used is water. No chemicals are used 

to process the product. The petitioner notes, due to food safety and economics, dried orange pulp 

manufacture must be co-located with orange juice processing facilities. 

International:

There is no list of individual non-organic agricultural commodities allowed under the Japanese Agricultural 

Standards (JAS), International Federation of Organic Agricultural Movements (IFOAM) or Codex standards – 

however these standards allow for up to 5% non-organic content. The EU Organic Standards do not list 

dried orange pulp. 

Ancillary substances: 

No ancillary substances were provided. 

Discussion:

The 2015 NOSB requested information from the public related to (1) commercial demand, (2) commercial 

availability, (3) alternatives, and (4) necessity and use. No specific comments supported relisting or 

addressed commercial availability of dried orange pulp. No organic handler commented in favor of the 

material. While the NOSB could not find organic dried orange pulp during a search of publicly available 

sourcing resources in February 2015, there were several listings for organic suppliers of oranges, organic 

juice, dried oranges and orange pulp – feedstock raw materials and byproduct industries for dried orange 

pulp. During the review period, the Subcommittee asked the following questions:

1) Is there an organic supply of international orange pulp, dried?

2) Is there a domestic supply of organic orange pulp, dried? 

3) Is it essential?

NOSB October 2019 proposals and discussion documents Page 61 of 230
There were no commenters who listed orange pulp, dried, as an ingredient in their products nor any 

certifiers who listed it in their review of materials in organic products. However, orange peel and orange 

pulp were listed as ingredients in organic products. During the Spring 2019 public subcommittee 

discussion, the Handling Subcommittee noted that this listing also has a patent which may limit its use in 

organic products. Other commenters requested that the Board consider the use of conventional pesticides 

in conventional orange production that may leave residue in the final product of orange pulp, dried. 

The Handling Subcommittee has voted to remove this item from the National List because orange pulp 

dried does not seem to be necessary for or consistent with organic handling (failing OFPA criteria at 7 U.S.C. 

§ 6517(c)(ii)–(iii)), and alternatives exist (failing OFPA criteria at § 6518(m)(6)). There were no comments 

that supported it use, nor no known organic products that include it as an ingredient. There is sufficient 

supply of organic oranges to produce dried orange pulp, and those wishing to purchase this product 

organically could work with manufacturers to source organic raw material. It is inconsistent with organic 

farming and handling to use a nonorganic product in organic foods, when an organic ingredient could be 

produced.

Subcommittee Vote:

Motion to remove orange pulp, dried from §205.606(n) of the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Not necessary for, or consistent with, 

organic handling and alternatives exist (§§ 6517 and 6518)

Motion by: Harriet Behar

Seconded by: Asa Bradman

Yes: 4 No: 1 Abstain: 0 Absent: 2 Recuse: 0

 Seaweed, Pacific kombu 

§205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed 

products labeled as “organic.”

Reference: 205.606(r) Seaweed, Pacific kombu.

Technical Report: 2016 TR (Marine Plants & Algae)

Petition(s): 2007 Petition

Past NOSB Actions: 05/2008 NOSB recommendation; 10/2015 NOSB Final Review

Recent Regulatory Background: Added to NL effective 03/15/12 (77 FR 8089); Renewed 03/15/2017 (82 FR 

14420)

Sunset Date: 03/15/2022

Subcommittee Review: 

Uses: 

Marine plants (seaweed) and algae are included on the National List in several sections and allowed for use 

in organic production and handling:

1) At §205.601(j)(1), Aquatic plant extracts are synthetic substances allowed in organic crop production, 

as plant or soil amendments, from other than hydrolyzed extracts where the extraction process is 

limited to the use of potassium hydroxide or sodium hydroxide; the solvent amount used is limited to 

that amount necessary for extraction.

2) At §205.605 (a) and (b), products from marine plants and algae including non-synthetic substances: 

alginic acid, agar, carrageenan, and the alginates are nonagricultural (nonorganic) substances allowed 

as ingredients in or on processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified 

ingredients or food group(s))’’ and may be used as ingredients in or on processed products labeled as 

NOSB October 2019 proposals and discussion documents Page 62 of 230
‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).” In addition, some minerals 

used for nutrient fortification, such as calcium, may be derived from marineplants.

3) At §205.606(d), four substances from marine plants and algae are specifically identified as 

nonorganically produced agricultural products allowed as ingredients in or on processed products 

labeled as ‘‘organic’’ when the specific product is not commercially available in “organic” form: (d)(2) 

beta-carotene extract color, derived from algae (Dunaliella salina), not produced using synthetic 

solvents and carrier systems or any artificial preservative; (k) Kelp used only as a thickener and 

dietary supplement; (r) Pacific kombu; and (v) Wakame seaweed (Undaria pinnatifida).

4) In addition, calcium used for fortification may be derived from marine plants. In 2012, about 23.8 

million metric tons worldwide of seaweed and other algae were harvested from aquaculture. Capture 

production, also known as wildcrafting produced about 1.1 million metric tons. Seaweed was used as 

food, in cosmetics and fertilizers, processed to extract thickening agents, and as an additive to animal 

feed (FAO, 2014).

Currently, Kombu is used as an ingredient to make stock for instant miso soup and Yuzu Ponzu.

Kombu is integral to the preparation of many Japanese traditional foods such as stock.

Manufacture:

Kombu is harvested from the ocean. After the crop is harvested, it is sun-dried. In general, for the 

preparation of stock for Japanese traditional food, dried Kombu is boiled in water.

International:

Canada - Canadian General Standards Board Permitted Substances List. This list was updated in 

November 2015. Although there is a Canadian organic aquaculture standard and accredited certifying 

bodies can certify to it, the standard itself is not referenced in government regulations and organic 

aquaculture products may not carry the Canada Organic logo. Aquatic plants and aquatic plant products 

not containing synthetic preservatives, such as formaldehyde, either extracted naturally (non-synthetic) 

or with potassium hydroxide or sodium hydroxide in approved situations are allowed as soil nutrients 

and amendments. Agar is also permitted as a medium for mushroom spawn production.

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999) - A proposal to amend the Codex guidelines to include organic 

aquaculture, including algae and products of algae, has been under consideration. Due to consensus 

issues, it is unclear whether this proposal will be adopted in the future (CAC, 2016). The Codex guidelines 

for organic also allow: 1) seaweed and seaweed products as a soil conditioner, 2) seaweed, seaweed 

meal, seaweed extracts, sea salts and salty water for pest control, 3) Carrageenan, 4) Alginic acid/sodium 

alginate/potassium alginate and 5) agar.

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008. Aquaculture is 

defined by the EEC as the rearing or cultivation of aquatic organisms including marine plants and algae 

using techniques designed to increase the production of the organisms in question beyond the natural 

capacity of the environment; the organisms remain the property of a natural or legal person throughout 

the rearing or culture stage, up to and including harvesting. Algae, including seaweed, can be used in the 

processing of organic food. Aquaculture production must be based on the maintenance of the 

biodiversity of natural aquatic ecosystems, the continuing health of the aquatic environment and the 

quality of surrounding aquatic and terrestrial ecosystems.

Japan Agricultural Standard (JAS) for Organic Production— The Japanese Agricultural Standard for 

Organic Plants (Notification 1065 of the Ministry of Agriculture, Forestry and Fisheries of October 27, 

2005) allows the use of dried algae as fertilizer for terrestrial plants.

NOSB October 2019 proposals and discussion documents Page 63 of 230
International Federation of Organic Agriculture Movements (IFOAM) – IFOAM is developing a standard 

for marine algae in its aquaculture expert forum. Seaweed is allowed as a soil input in appendix 2 of the 

IFOAM norms (IFOAM, 2014). In addition, several hydrocolloids derived from algae such as carrageenan

and alginates are allowed as food additives (IFOAM, 2014).

Ancillary substances:

It does not appear that any ancillary substances such as anti-caking agents, preservatives or colorings 

are used in the manufacture of Pacific Kombu products.

Discussion:

As a marine material, use of Kombu seaweed is part of an ongoing discussion focused on environmental 

concerns about the harvesting and use of marine algae and related materials (see 

https://www.ams.usda.gov/sites/default/files/media/Marine%20Plants%20and%20Algae%20TR.pdf; and 

https://www.ams.usda.gov/sites/default/files/media/MSMarineMaterialsDiscDocOct2018Web.pdf) and 

whether standards preventing overharvesting are needed to protect ocean environments. No written or 

oral comments were submitted for the April 2019 NOSB meeting by users of Kombu seaweed. Written 

comments addressed environmental concerns about overharvesting and also the potential for Kombu 

seaweed to concentrate heavy metals and/or radioactive isotopes of iodine which may be present in 

contaminated waters. Annotations were recommended for risk-based testing for toxic materials, using a 

decision tree to identify harvesting areas where testing would need to be performed. One commenter 

suggested that certification as a wild-crafted organic product could prevent overharvesting and 

contamination, and in the absence of such standards, the material should not be relisted. 

Additional information requested by Subcommittee: None

 Subcommittee Vote:

Motion to remove seaweed, Pacific kombu from the National List based on the following criteria in the

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA 

Motion by: Asa Bradman

Seconded by: Steve Ela

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

Wakame seaweed 

§205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed 

products labeled as “organic.”

Reference: 205.606(v) Wakame seaweed (Undaria pinnatifida).

Technical Report: 2016 TR (Marine Plants & Algae)

Petition(s): 2007 Petition

Past NOSB Actions: 04/2007 NOSB recommendation; 04/2010 NOSB sunset recommendation; 10/2015 

NOSB Final Review

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022

NOSB October 2019 proposals and discussion documents Page 64 of 230
Subcommittee Review: 

Uses: 

Acidulant, pH control, flavoring agent, sequestrant, and buffering agent. Used as an emulsifier in dairy. 

Marine plants (seaweed) and algae are included on the National List in several sections and allowed for use 

in organic production and handling:

1) At §205.601(j)(1), Aquatic plant extracts are synthetic substances allowed in organic crop 

production, as plant or soil amendments, from other than hydrolyzed extracts where the 46-

extraction process is limited to the use of potassium hydroxide or sodium hydroxide; the solvent 

amount used is limited to that amount necessary for extraction.

2) At §205.605 (a) and (b), products from marine plants and algae including non-synthetic 

substances: alginic acid, agar and carrageenan, and the alginates are nonagricultural (nonorganic) 

substances allowed as ingredients in or on processed products labeled as ‘‘organic’’ or ‘‘made with 

organic (specified ingredients or food group(s))’’ and may be used as ingredients in or on 

processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food

group(s)).” In addition, some minerals used for nutrient fortification, such as calcium, may be 

derived from marine plants.

3) In §205.606(d), four substances from marine plants and algae are specifically identified as 

 nonorganically produced agricultural products allowed as ingredients in or on processed 

 products labeled as ‘‘organic’’ when the specific product is not commercially available in 

 “organic” form: (d)(2) beta-carotene extract color, derived from algae (Dunaliella salina), not 

 produced using synthetic solvents and carrier systems or any artificial preservative; (k) Kelp 

 used only as a thickener and dietary supplement; (r) Pacific kombu; and (v) Wakame seaweed 

 (Undaria pinnatifida).

4) In addition, calcium used for fortification may be derived from marine plants

In 2012, about 23.8 million metric tons worldwide of seaweed and other algae were harvested from 

aquaculture. Capture production or wildcrafting produced about 1.1 million metric tons. Seaweed 

was used as food, in cosmetics and fertilizers, processed to extract thickening agents, and as an 

additive to animal feed (FAO, 2014).

Wakame seaweed is a traditional accompaniment to Miso Soup in Japanese cuisine.

Manufacture:

Wakame is naturally occurring in the ocean. It is harvested and sun dried. It is often cut into smaller 

pieces and salted for shelf life.

International:

Canada - Canadian General Standards Board Permitted Substances List. This list was updated in 

November 2015. Although there is a Canadian organic aquaculture standard and accredited certifying 

bodies can certify to it, the standard itself is not referenced in government regulations and organic 

aquaculture products may not carry the Canada Organic logo. Aquatic plants and aquatic plant 

products not containing synthetic preservatives, such as formaldehyde, either extracted naturally 

(non-synthetic) or with potassium hydroxide or sodium hydroxide in approved situations are allowed 

as soil nutrients and amendments. Agar is also permitted a medium for mushroom spawn production.

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing 

of Organically Produced Foods (GL 32-1999) - A proposal to amend the Codex guidelines to include 

organic aquaculture, including algae and products of algae, has been under consideration. Due to 

NOSB October 2019 proposals and discussion documents Page 65 of 230
consensus issues, it is unclear whether this proposal will be adopted in the future (CAC, 2016). The 

Codex guidelines for organic also allow: 1) seaweed and seaweed products as a soil conditioner, 2) 

seaweed, seaweed meal, seaweed extracts, sea salts and salty water for pest control, 3) Carrageenan, 

4) Alginic acid/sodium alginate/potassium alginate and 5) agar.

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008. Aquaculture 

is defined by the EEC as the rearing or cultivation of aquatic organisms including marine plants and 

algae using techniques designed to increase the production of the organisms in question beyond the 

natural capacity of the environment; the organisms remain the property of a natural or legal person 

throughout the rearing or culture stage, up to and including harvesting. Algae, including seaweed, can 

be used in the processing of organic food. Aquaculture production must be based on the maintenance 

of the biodiversity of natural aquatic ecosystems, the continuing health of the aquatic environment 

and the quality of surrounding aquatic and terrestrial ecosystems.

Japan Agricultural Standard (JAS) for Organic Production— The Japanese Agricultural Standard for 

Organic Plants (Notification 1065 of the Ministry of Agriculture, Forestry and Fisheries of October 

27, 2005) allows the use of dried algae as fertilizer for terrestrial plants.

International Federation of Organic Agriculture Movements (IFOAM) – IFOAM is developing a 

standard for marine algae in its aquaculture expert forum. Seaweed is allowed as a soil input in 

Appendix 2 of the IFOAM norms (IFOAM, 2014). In addition, several hydrocolloids derived from algae 

such as carrageenan and alginates are allowed as additives (IFOAM, 2014).

Ancillary substances:

It does not appear that any ancillary substances such as anti-caking agents, preservatives or 

colorings are used in the manufacture of wakame products, other than salt.

Discussion:

As a marine material, use of Wakame seaweed is part of an ongoing discussion focused on 

environmental concerns about the harvesting and use of marine algae and related materials (see 

https://www.ams.usda.gov/sites/default/files/media/Marine%20Plants%20and%20Algae%20TR.pdf; 

and https://www.ams.usda.gov/sites/default/files/media/MSMarineMaterialsDiscDocOct2018Web.pdf) 

and whether standards preventing overharvesting are needed to protect ocean environments. Among 

written and oral comments submitted for the April 2019 NOSB, only one user of this materials was

noted. Written comments addressed environmental concerns about overharvesting and also the 

potential for Wakame seaweed to concentrate heavy metals and/or other contaminants which may be 

present in polluted waters. Annotations were recommended for risk-based testing for toxic materials, 

using a decision tree to identify harvesting areas where testing would need to be performed. As with 

Kombu seaweed, one commenter suggested that certification as a wild-crafted organic product could 

prevent overharvesting and contamination, and in the absence of such standards, the material should 

not be relisted.

Additional information requested by Subcommittee: None

Subcommittee Vote:

Motion to remove seaweed, wakame (Undaria pinnatifida) from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA 

Motion by: Asa Bradman

Seconded by: Steve Ela

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

NOSB October 2019 proposals and discussion documents Page 66 of 230
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

C6, C8, C10, C12 Naturally Derived Fatty Alcohol/MASCOL80

July 16, 2019

Summary of Petition 

A petition requesting the addition of revised active ingredient C6, C8, C10, C12 naturally derived fatty 

alcohol was received by the NOSB in December 2018 to be added to section §205.601(k) of the National 

List. The Petition asks for the substance to be annotated for “sucker control on organic tobacco crops”. 

The petitioner has made numerous revisions to the original petition (2015). According to Dr. Clarissa 

Matthews, “the original petition was for use in tobacco and other crops, contained reference to multiple 

materials including inerts, and did not specify the range of fatty alcohols in the material MASCOL80. The 

re-petition as revised specifies use on tobacco only, clarifies material being petitioned, and includes the 

full range of alcohols (i.e., C6-C12) in MASCOL80.”

The NOSB’s Formal recommendation on November 2, 2017 to the NOP, stated among other issues, the 

use of a synthetic growth regulator is not compatible with a system of sustainable and organic 

agriculture. The re-petition specifies the need of this synthetic growth regulator on organic tobacco for 

sucker control. There could be a human health concern caused by exposure to nicotine when hand 

suckering. The NOSB also received a petitioned signed by many tobacco farmers, stating they need this 

material, which had been allowed by a few organic certifiers in the past. Growing organic tobacco can be 

one organic crop in a longer crop rotation. Some producers have stated if this material is not approved, 

they may choose to no longer grow the other crops organically on their farms.

The NOSB will review the action of fatty alcohols as a synthetic growth regulator and its compatibility 

with a system of sustainable and organic agriculture. Currently, EPA’s registration for this material is 

limited to use on tobacco and the technical review received by the NOSB only discussed fatty alcohols 

for the EPA registered use. 

Category: Synthetic Substance Allowed for Use in Organic Crop Production 

NOP Reference: 205.601 Synthetic Substance Allowed for use in Organic Crop Production. 

NOP Section: 205.601(k)(2) - As a Plant Growth Regulator 

Requested Annotation: For sucker control in organic tobacco production

Category 1: Classification 

1. For CROP use: This substance is Synthetic.

 Is the substance formulated or manufactured by a process that chemically changes a substance 

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so, 

describe, using NOP 5033-1 as a guide. 

 

Fatty alcohols can be produced from natural fats from plants or animals, or from petroleum 

sources. In either case, chemical changes are required to produce fatty alcohols.

NOSB October 2019 proposals and discussion documents Page 67 of 230
2. Reference to appropriate OFPA category:

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from 

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and 

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in 

production and contains synthetic inert ingredients that are not classified by the Administrator

of the Environmental Protection Agency as inerts of toxicological concern?

Fatty alcohols do not fall into any of the OFPA categories. Fatty alcohols produced as a mixture 

of four aliphatic alcohols are not considered inert by the Environmental Protection Agency nor 

are they included in List 4. Fatty alcohols may be registered with the EPA only for tobacco sucker 

control. N-decyl alcohol (decanol) and n-octyl alcohol (octanol) are individually approved by the 

US Food and Drug Administration (FDA) for food and non-food use as solvents or co-solvents.

Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? 

There appears to be no known detrimental chemical interactions between fatty alcohols and 

other materials used in organic farming systems. Mineral oil, cooking oil or paraffin oil are 

currently the only topping and suckering substances used by organic crop producers and there is 

no proven adverse impact with these substances.

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment? 

[§6518(m)(2)]

The log Kow is an indicator of a chemical’s tendency to bioaccumulate. The TR reports log Kow’s 

for octanal and decanol at 3.15 and 4.57 respectively, which are moderately low. The TR also 

notes that linear fatty alcohols in general are easily biodegradable.

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

According to the Safer Choice determination of the EPA, 1-decanol, 1-octanol, 1-dodecanol and 

the C6-C12 alcohols are expected to be of low concern for environmental contamination based 

on experimental and modeled data. Linear fatty alcohols in general are easily biodegradable. 

The solubility of fatty alcohols in water decreases with an increasing C-chain length. Fatty 

alcohols possess only moderate acute toxicity for aquatic organisms. In general, in their range of 

water solubility no toxic effects are observed. 

The fatty alcohols from both natural and manufactured sources represent a low risk for 

environmental contamination.

4. Discuss the effect of the substance on human health. 

There is no evidence to suggest that the aliphatic alcohols cause increased susceptibility to 

health problems in infants and children. Based on the results of the available studies, no 

endpoints of toxicological concern have been identified for human health risk assessment 

NOSB October 2019 proposals and discussion documents Page 68 of 230
purposes. The EPA concluded that there are no human risks of concern for aliphatic alcohols (TR 

lines 396 – 399).

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms (including 

the salt index and solubility of the soil), crops and livestock. [§6518(m)(5)] 

When fatty alcohols are applied to tobacco plants for suckering with a surfactant such as tween 

80, an average residue of 1.6 parts per million (ppm) of the applied fatty alcohols and 1.0 ppm of 

the surfactant remain on the cured leaves. Over 7000 ppm of naturally occurring fatty alcohols 

are also present in and on the cured leaves. Fatty alcohols induce a low incidence of 

polynucleate root tip cells or root tip cells with fragmented nuclei. The fatty alcohols are 

produced naturally, in all living organisms, from bacteria to man, and thus, are widely present 

throughout the natural world. In any agro-ecosystem, fatty alcohols will be present from natural 

sources. The introduction of C6-C12 fatty alcohols for topping and suckering may produce short 

term toxicity to many organisms in the range of 1-100 milligrams/liter, however; because the 

application rate is intermittent, and biodegradability and removal rate are high for this 

substance no readily observable effects occur in the agroecosystem (TR lines 342-352).

6. Are there any adverse impacts on biodiversity? (§205.200) 

Fatty alcohols are chemicals that naturally occur in all plants and animals. They are known for 

their high level of biodegradability in the environments. Their derivative products are 

additionally designed to rapidly degrade after use and are not considered endocrine disrupters.

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)]

Topping may be done by hand or with special machines that cut the flower heads and sacrifice a 

few leaves. Topping requires two or three trips over the field to catch all the plants. Suckers 

can be removed by hand as well as stunted by carefully applying approved soybean oil or 

mineral oil to the top of the plant. Topping and suckering are the most time-consuming tasks 

associated with growing organic tobacco and may be necessary every week for 10 weeks.

One issue with suckering and topping is tobacco toxicity to workers performing the task. 

Tobacco is well documented as having negative human health effects (i.e. cancer, heart attack, 

lung disease) when in contact with skin or mucous membranes. Workers in contact with 

tobacco plants may also experience nausea and other health concerns from tobacco poisoning.

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

The review and subsequent denial of the fatty alcohol petition at the Fall 2017 NOSB revolved 

around several issues. First, the uses requested for the petitioned material were broad and 

extended beyond the limited use for tobacco desuckering. Since other uses for the petitioned 

material were not allowed by the Environmental Protection Agency, the board was faced with 

either adding an annotation to the listing or denying the petition. Secondly, the petition was 

not clear as to which fatty alcohols were being requested. The petition contained reference to 

multiple materials including inerts, and did not specify the range of fatty alcohols being 

NOSB October 2019 proposals and discussion documents Page 69 of 230
requested. Thirdly, there was little evidence provided for essentiality to organic production in 

the original petition. The Board received few comments noting that this material was essential 

for organic tobacco production. The Board was also not aware that fatty alcohols had been 

approved by some certifiers and not by others and that some growers were already using this 

material. 

During review of the current petition several of these issues have been addressed. First, the 

current petition is limited to the use of fatty alcohols for organic tobacco production. Secondly, 

the fatty alcohols being requested are clearly spelled out and match those available in the 

products previously allowed by some certifiers. Thirdly, the Board received numerous 

comments during the Spring 2019 Board meeting noting the essentiality of this material to 

organic tobacco growers. These comments were received even though the material was not on 

the meeting agenda. Numerous tobacco growers noted that without this material, they would 

be unable to produce organic tobacco and would most likely drop their organic certification, 

including the certification for crops they use in rotation with tobacco. The reasons for 

essentiality included:

• Other currently available materials are ineffective or sporadically effective whereas fatty 

alcohols are effective and reliable.

• Manual desuckering involves numerous passes through the fields and exposes workers 

to the potential for tobacco poisoning and numerous health issues. The use of fatty 

alcohols prevents this exposure and is necessary to protect human health.

• The suckers on tobacco plants provide habit for aphids and increase the susceptibility of 

the plant to other pests. Desuckering the plants reduces pest pressure.

The crops subcommittee is well aware of the negative impacts on human health of tobacco use. 

However, tobacco is a legal crop and a crop eligible for organic certification. Like any other 

material reviewed for use on organic crops, the committee is limiting our review to whether the 

material meets the criteria necessary for adding it to the National List as a crop production aid. 

Since fatty alcohols occur naturally throughout the plant world, break down readily after use, 

help to prevent worker exposure to tobacco poisoning, and reduce insect problems, they are 

compatible with a system of sustainable agriculture.

Minority opinion: 

During its Fall 2017 board meeting, the NOSB determined that the use of a synthetic plant growth 

regulator for sucker control of tobacco is not compatible with a system of organic agriculture. Following 

the re-petition of this material, the NOSB heard from numerous organic tobacco farmers in the spring of 

2019 who rely on this material. While the testimony provided by growers was compelling and included 

worker health concerns and some associated pest prevention benefits, the primary reason for the 

petition of this material is to enable greater economic returns. 

The TR for this material notes that fatty alcohols do not fall into any of the OFPA 

categories. Additionally, it states:

"The aim of sucker control is to focus the plant’s energy into filling the leaves rather than growing the 

flower. Because tobacco sells by weight, heavier leaves are favored economically. In organic tobacco 

production, early topping to improve yield and quality is usually done by hand. Suckers can be removed 

by hand as well as stunted by carefully applying approved soybean oil or mineral oil to the top of the 

plant." (TR Lines 494-498) 

NOSB October 2019 proposals and discussion documents Page 70 of 230
Although manual control is clearly more expensive, the same can be said for manual sucker removal on 

tomatoes, for example, a task that requires weekly labor during the growing season. Allowing fatty 

alcohols to replace manual practices in tobacco would have the effect of subsidizing tobacco with a 

synthetic material over a crop like tomatoes, where similar hand removal of suckers is often required.

The foundation of organic agriculture is predicated on using natural, manual, mechanical, and cultural 

controls over synthetic materials. In many cases, this means utilizing hand labor and is part of why 

organic receives a price premium. Labor saving and greater economic returns are insufficient criteria for 

adding a synthetic material to the National List. 

Classification Motion: 

 

Motion to classify fatty alcohols C6, C8, C10, C12 naturally derived fatty alcohol as synthetic.

Motion by: Jesse Buie

Seconded by: Harriet Behar

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

National List Motion:

Motion to add fatty alcohols C6, C8, C10, C12 Naturally Derived Fatty Alcohol at 205.601 for 

sucker control on organic tobacco crops.

Motion by: Jesse Buie

Seconded by: Rick Greenwood

Yes: 4 No: 2 Abstain: 1 Absent: 1 Recuse: 0

Approved by Steve Ela, Crop Subcommittee Chair, to transmit to NOSB August 14, 2019

NOSB October 2019 proposals and discussion documents Page 71 of 230
NOSB October 2019 proposals and discussion documents Page 72 of 230
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Potassium Hypochlorite

July 16, 2019

Summary of Petition 

[https://www.ams.usda.gov/sites/default/files/media/PotassiumHypochloriteRevisedPetition03262019.

pdf]: 

The petitioner is requesting potassium hypochlorite solution be included on the National List as follows: 

§ 205.601 Synthetic substances allowed for use in organic crop production: (2) Chlorine materials - For

pre-harvest use, residual chlorine levels in the water in direct crop contact or as water from cleaning

irrigation systems applied to soil must not exceed the maximum residual disinfectant limit under the

Safe Drinking Water Act, except that chlorine products may be used in edible sprout production

according to EPA label directions.

Potassium hypochlorite is produced by the reaction of chlorine with a solution of potassium hydroxide: 

Cl2 + 2 KOH → KCl + KClO + H2O 

Potassium hypochlorite (KOCl) is registered by EPA and is FDA approved. This material is approved for 

use in many agricultural applications. This product can address needs for irrigation equipment 

maintenance and to meet Food Safety Modernization Act (FSMA) requirements to provide sanitation to 

pre-harvest water for irrigation. The material can also incidentally provide a source of potassium for 

plants.

As described in the petition, potassium hypochlorite shares similar chemistry and uses as sodium 

hypochlorite (bleach), except for the replacement of sodium for potassium, potentially reducing issues 

with salinization of soils. At the request of the petitioner, the FDA reviewed this product in comparison 

to NaOCl. FDA found the substitution of potassium ions for sodium, in such applications as NaOCl 

solutions, would not raise new safety concerns. They also stated that a Food Contact Notification (FCN) 

would not be required to use KOCl in the same manner that NaOCl is permitted. KOCl is exempt from 

requirements for a food tolerance (https://www.federalregister.gov/documents/2011/03/02/2011-

4534/potassium-hypochlorite-exemption-from-the-requirement-of-a-tolerance) 

Like bleach and other chlorine sanitizing compounds currently on the National List, KOCl is a strong 

oxidant and can pose serious risks to human health if acute high exposure occurs or from chronic lower 

level exposures. It is a dermal, respiratory, ocular, and mucous membrane irritant. Bleach is a known 

asthmagen, and, given the similar chemistries and mechanism of action, KOCL is also likely to cause or 

exacerbate asthma. KOCL is toxic to fish and other aquatic organisms. Like bleach and other chlorine 

compounds, strict adherence to the label is required. Use of chlorine compounds in organic crop 

production, including calcium hypochlorite, sodium hypochlorite, and chlorine dioxide, were reviewed in 

a 2011 Technical Report (TR) 

(https://www.ams.usda.gov/sites/default/files/media/Chlorine%202%20TR%202011.pdf). Information 

in this TR is transferable to the KOCl.

Given the nearly identical chemistry and human and environmental risks to sodium and calcium 

hypochlorite, currently listed under (§ 205.601(2), and the potential benefit of avoiding application of 

NOSB October 2019 proposals and discussion documents Page 73 of 230
sodium to soils, the Crops Subcommittee recommends listing of KOCl for the treatment of irrigation 

water not to exceed the maximum residual disinfectant limit under the Safe Drinking Water Act. 

Summary of Review: 

Category 1: Classification 

1. For CROP use: Is the substance _______ Non-synthetic or ____X___ Synthetic?

 Is the substance formulated or manufactured by a process that chemically changes a substance 

extracted from naturally occurring plant, animal, or mineral sources? [OFPA § 6502(21)] If so, 

describe, using NOP 5033-1 as a guide. 

2. Reference to appropriate OFPA category: 

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§ 6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from 

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and 

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in 

production and contains synthetic inert ingredients that are not classified by the Administrator 

of the Environmental Protection Agency as inerts of toxicological concern?

No.

Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§ 6518(m)(1)]

When used in irrigation water and compliant with maximum residual disinfectant limit under the 

Safe Drinking Water Act [4 ppm free chlorine], the substance is unlikely to have detrimental 

chemical interactions with other materials used in organic farming systems.

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment? [§

6518(m)(2)]

Like bleach and other chlorine sanitizing compounds currently on the National List, KOCl is a 

strong oxidant and can pose serious risks to human health if acute high exposure occurs or from 

chronic lower level exposures. It is a dermal, respiratory, ocular, and mucous membrane irritant. 

Bleach is a known asthmagen, and, given the similar chemistries and mechanism of action, KOCL 

is also likely to cause or exacerbate asthma. KOCL is toxic to fish and other aquatic organisms. 

Like bleach and other chlorine compounds, strict adherence to the label is required. 

According to the petition, “...hypochlorite salts break down rapidly in to non-toxic compounds 

when exposed to sunlight. In seawater, chlorine levels decline rapidly: however, hypobromite 

(which is acutely toxic to aquatic organisms) is formed. Due to the presence of 65 ppm of 

bromide ion in seawater, hypochlorite salts form hypobromite salts. Hypobromite salts are very 

unstable to photolysis and rapidly break down back to bromide ion under the influence of ultra 

violet light [sunlight].

NOSB October 2019 proposals and discussion documents Page 74 of 230
3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§ 6518(m)(3)]

If the material is used according to label requirements, the probability of adverse environmental 

contamination is low. The petitioned use is in irrigation water, so the material will be directly 

released to the environment. The levels, generally 1-2 ppm and not to exceed 4 ppm, are 

consistent with drinking water standards and unlikely to pose a threat to human health or the 

environment. KOCl is not persistent. The major environmental risks are due to accidental 

releases of concentrated precursor material during manufacture (Cl2) or transport of finished 

product before dilution for irrigation purposes.

4. Discuss the effect of the substance on human health. [§ 6517(c)(1)(A)(i); § 6517(c)(2)(A)(i); § 

6518(m)(4)]. 

Like bleach and other chlorine sanitizing compounds currently on the National List, KOCl is a 

strong oxidant and can pose serious risks to human health if acute high exposure occurs or from 

chronic lower level exposures. It is a dermal, respiratory, ocular, and mucous membrane irritant. 

Bleach is a known asthmagen, and, given the similar chemistries and mechanism of action, KOCL 

is also likely to cause or exacerbate asthma. The threshold or duration of exposures that might 

result in long-term respiratory problems is unknown. Short low level term exposures may result 

in transitory respiratory and eye irritation. Like bleach and other chlorine compounds, strict 

adherence to the label is required and care must be taken to protect workers diluting material 

for irrigation use. 

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms (including 

the salt index and solubility of the soil), crops and livestock. [§ 6518(m)(5)] 

The application rate of 1-2 ppm, not to exceed free chlorine of 4 ppm, is consistent with drinking 

water standards for human. Use at this level in irrigation water is unlikely to have adverse 

biological and chemical interactions in the agroecosystem. Because KOCL substitutes potassium 

for sodium, it will not increase soil salinization.

6. Are there any adverse impacts on biodiversity? (§ 205.200) 

Unlikely. 

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§ 6518(m)(6)]

Sodium and calcium hypochlorite can be used for the same purposes as the petitioned material. 

KOCl has the distinct benefit over NaOCL because it does not contain sodium and potassium and

is a plant nutrient. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§ 6518(m)(7)]

NOSB October 2019 proposals and discussion documents Page 75 of 230
Overall, yes. Like other chlorine compounds, KOCl poses human health and environmental 

concerns, reviewed in part in the chlorine materials 2011 TR. However, FSMA requires that 

irrigation water used during certain growing activities have an acceptable microbial water 

quality profile (MWQP) and KOCL can meet this need and can also reduce fouling of irrigation 

equipment. These purposes are consistent with allowed uses of other chlorine materials. KOCl 

provides another tool to meet these requirements, and avoids application of sodium to soils.

Classification Motion: 

 

Motion to classify potassium hypochlorite as synthetic

Motion by: Steve Ela 

Seconded by: Dan Seitz

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

National List Motion: 

Motion to add potassium hypochlorite at § 205.601(2): Chlorine materials - For use in water for 

irrigation purposes, residual chlorine levels in the water in direct crop contact or as water from 

cleaning irrigation systems applied to soil must not exceed the maximum residual disinfectant 

limit under the Safe Drinking Water Act.

Motion by: Steve Ela 

Seconded by: Rick Greenwood

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

NOSB October 2019 proposals and discussion documents Page 76 of 230
Sunset 2021 

Meeting 2 - Review

Crops Substances §205.601, §205.602 

October 2019

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the 

National List of Allowed and Prohibited Substances (National List) that are coming up for sunset review 

by the National Organic Standard Board (NOSB). The following list announces substances that are on the 

National List for use in organic crop production that must be reviewed by the NOSB and renewed by the 

USDA before their sunset dates in 2021. This list provides the substance’s current status on the National 

List, use description, references to past technical reports, past NOSB actions, and regulatory history, as 

applicable. 

Request for Comments

Written public comments will be accepted through October 3, 2019 via www.regulations.gov. 

Comments received after that date may not be reviewed by the NOSB before the October meeting. 

NOSB October 2019 proposals and discussion documents Page 77 of 230
Sunset 2021 

Meeting 2 - Review

Crops Substances §205.601, §205.602 

October 2019

Note: With the exception of ferric phosphate and hydrogen chloride the materials included in this list 

are undergoing early sunset review as part of the November 18, 2016, NOSB recommendation on 

efficient workload re-organization. 

Reference: 205.601 Synthetic substances allowed for use in organic crop production.

Hydrogen peroxide (a)

Hydrogen peroxide (i)

Soaps, ammonium

Oils, horticultural (e)

Oils, horticultural (i)

Pheromones

Ferric phosphate

Potassium bicarbonate

Magnesium sulfate

Hydrogen chloride

 

Reference: 205.602 Nonsynthetic substances prohibited for use in organic crop production.

Ash from manure burning

Sodium fluoaluminate

NOSB October 2019 proposals and discussion documents Page 78 of 230
Hydrogen peroxide—§205.601(a)

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: 205.601(a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

systems. (4) Hydrogen peroxide.

Technical Report(s): 1995 TAP; 2015 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation -deferred; 

06/2006 sunset recommendation; 10/2010 sunset recommendation

10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review:

Hydrogen peroxide is widely used as a disinfectant and bleaching agent. It is an effective and an 

environmentally benign substance used to reduce and control microorganisms for food safety purposes. 

It is critical for sanitizing aseptic packaging. It is a weak acid but a strong oxidizer and this makes it very 

useful as a fungicide, cleaning agent, and for disease control. 

Hydrogen peroxide is a very simple molecule with a formula of H2O2. Virtually all modern production 

facilities manufacture commercial hydrogen peroxide solutions using large, strategically located 

anthraquinone autoxidation processes. Improved production methods and facilities based on the 

anthraquinone (AO) process have recently appeared in the commercial patent literature. 

Hydrogen peroxide is a naturally occurring inorganic compound; however, the sources of hydrogen 

peroxide used in commercial fungicides, disinfectants and antiseptic products are produced through 

chemical synthesis. Industrial methods for the preparation of hydrogen peroxide are categorized as 

oxidation-reduction reactions. Modern commercial methods for hydrogen peroxide synthesis involve 

the transition-metal catalyzed chemical reduction of an alkyl anthraquinone with hydrogen (H2) gas to 

the corresponding hydroquinone followed by regenerative oxidation of the latter species in air.

Contamination is not expected when purified forms of hydrogen peroxide are released to the 

environment following normal use. At typical pesticide concentrations, hydrogen peroxide is expected 

to rapidly degrade to oxygen gas and water (US EPA, 2007). Large-volume spills and other releases of 

concentrated hydrogen peroxide could present a fire hazard since the substance readily decomposes to 

release oxygen gas. Pure hydrogen peroxide is not flammable and can be diluted with clean water to 

minimize the risk of fire. Although concentrated hydrogen peroxide is nonflammable, it is a powerful 

oxidizing agent that may spontaneously combust on contact with organic material and becomes 

explosive when heated. Combustion reactions and explosions resulting from accidental spills of 

concentrated hydrogen peroxide could therefore lead to environmental degradation.

A Technical Report (TR) was commissioned in 2015 for hydrogen peroxide since the information from 

the previous 1995 TAP was old and incomplete. It showed that hydrogen peroxide is inherently unstable 

and breaks down readily into oxygen and water. (TR Evaluation question 3-5). While it is toxic to disease 

spores and cells on contact, it has absolutely no residual effect. It has low or no impacts on birds, 

humans, or fish if it is used according to the label and protective application measures are taken. There 

can be some effects on soil microbiota in the very top layer of soil where it may come in contact, but 

because it breaks down so quickly, soil life is quickly restored. (TR 2015 Evaluation Question #8). 

NOSB October 2019 proposals and discussion documents Page 79 of 230
While there are some alternatives on the National List for sanitizers and disinfectants, as well as some 

essential oils with antiseptic properties, the National List items are not necessarily any better or safer 

than hydrogen peroxide, and the essential oils have not been studied to compare with Hydrogen 

peroxide side-by side to see if they are equally as effective and benign. (TR Evaluation question 11). 

Certain bacterial and fungal products that are beneficial in controlling plant diseases may be valid 

alternatives for some uses as a fungicide, but often these are best used as preventatives and are not 

effective once a disease has taken hold, and they are not good substitutes in all situations. Likewise, 

some biological, cultural and physical methods keep the need for use of hydrogen peroxide to a 

minimum, but don't apply to every situation. (TR Evaluation question 12). 

In the 2015 sunset review most public comment supported keeping hydrogen peroxide on the National 

List. It was frequently mentioned that it is one of the few tools left against fire blight now that 

antibiotics cannot be used. It is widely used to clean equipment, in mushroom production, and to 

alternate with other materials for resistance management. No comments were put forward with new 

information that would contribute to the OFPA criteria review. The NOSB found the material to meet 

OFPA criteria and had no objection to continued listing. No significant new issues were raised by the 

public. 

During the Spring 2019 NOSB meeting the Crops Committee received comments in favor of relisting 

hydrogen peroxide and no comments against relisting. Comments included the following:

• Hydrogen peroxide is an effective microbial pesticide used in the orchard setting for the 

sanitation of equipment such as picking bags and pruning shears. It is also used as an algicide 

and disinfectant, including for irrigation system cleaning. 

• With the loss of antibiotics, hydrogen peroxide has become an extremely important tool in 

controlling fire blight in both organic apples and pears. 

Subcommittee Vote:

Motion to remove hydrogen peroxide from §205.601(a) of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Jesse Buie

Seconded by: Harriet Behar

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

Hydrogen peroxide—§205.601(i)

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: 205.601(i) As plant disease control. (5) Hydrogen peroxide.

Technical Report(s): 1995 TAP; 2015 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation -deferred; 

06/2006 sunset recommendation; 10/2010 sunset recommendation

10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review:

Hydrogen peroxide is widely used as a disinfectant and bleaching agent. It is an effective and an 

environmentally benign substance used to reduce and control microorganisms for food safety purposes. 

NOSB October 2019 proposals and discussion documents Page 80 of 230
It is critical for sanitizing aseptic packaging. It is a weak acid but a strong oxidizer and this makes it very 

useful as a fungicide, cleaning agent, and for disease control. 

Hydrogen peroxide is a very simple molecule with a formula of H2O2. Virtually all modern production 

facilities manufacture commercial hydrogen peroxide solutions using large, strategically located 

anthraquinone autoxidation processes. Improved production methods and facilities based on the 

anthraquinone (AO) process have recently appeared in the commercial patent literature. 

Hydrogen peroxide is a naturally occurring inorganic compound; however, the sources of hydrogen 

peroxide used in commercial fungicides, disinfectants and antiseptic products are produced through 

chemical synthesis. Industrial methods for the preparation of hydrogen peroxide are categorized as 

oxidation-reduction reactions. Modern commercial methods for hydrogen peroxide synthesis involve 

the transition-metal catalyzed chemical reduction of an alkyl anthraquinone with hydrogen (H2) gas to 

the corresponding hydroquinone followed by regenerative oxidation of the latter species in air.

Contamination is not expected when purified forms of hydrogen peroxide are released to the 

environment following normal use. At typical pesticide concentrations, hydrogen peroxide is expected 

to rapidly degrade to oxygen gas and water (US EPA, 2007). Large-volume spills and other releases of 

concentrated hydrogen peroxide could present a fire hazard since the substance readily decomposes to 

release oxygen gas. Pure hydrogen peroxide is not flammable and can be diluted with clean water to 

minimize the risk of fire. Although concentrated hydrogen peroxide is nonflammable, it is a powerful 

oxidizing agent that may spontaneously combust on contact with organic material and becomes 

explosive when heated. Combustion reactions and explosions resulting from accidental spills of 

concentrated hydrogen peroxide could therefore lead to environmental degradation.

A Technical Report (TR) was commissioned in 2015 for hydrogen peroxide since the information from 

the previous 1995 TAP was old and incomplete. It showed that hydrogen peroxide is inherently unstable 

and breaks down readily into oxygen and water. (TR Evaluation question 3-5). While it is toxic to disease 

spores and cells on contact, it has absolutely no residual effect. It has low or no impacts on birds, 

humans, or fish if it is used according to the label and protective application measures are taken. There 

can be some effects on soil microbiota in the very top layer of soil where it may come in contact, but 

because it breaks down so quickly, soil life is quickly restored. (TR 2015 Evaluation Question #8). 

While there are some alternatives on the National List for sanitizers and disinfectants, as well as some 

essential oils with antiseptic properties, the National List items are not necessarily any better or safer 

than hydrogen peroxide, and the essential oils have not been studied to compare with Hydrogen

peroxide side-by side to see if they are equally as effective and benign. (TR Evaluation question 11). 

Certain bacterial and fungal products that are beneficial in controlling plant diseases may be valid 

alternatives for some uses as a fungicide, but often these are best used as preventatives and are not 

effective once a disease has taken hold, and they are not good substitutes in all situations. Likewise, 

some biological, cultural and physical methods keep the need for use of hydrogen peroxide to a 

minimum, but don't apply to every situation. (TR Evaluation question 12). 

In the 2015 sunset review most public comment supported keeping hydrogen peroxide on the National 

List. It was frequently mentioned that it is one of the few tools left against fire blight now that 

antibiotics cannot be used. It is widely used to clean equipment, in mushroom production, and to 

alternate with other materials for resistance management. No comments were put forward with new 

information that would contribute to the OFPA criteria review. The NOSB found the material to meet 

OFPA criteria and had no objection to continued listing. No significant new issues were raised by the 

public. 

NOSB October 2019 proposals and discussion documents Page 81 of 230
During the Spring 2019 NOSB meeting the Crops Committee received comments in favor of relisting

hydrogen peroxide and no comments against relisting. Comments included the following:

• Hydrogen peroxide is an effective microbial pesticide used in the orchard setting for the 

sanitation of equipment such as picking bags and pruning shears. It is also used as an algicide 

and disinfectant, including for irrigation system cleaning. 

• With the loss of antibiotics, hydrogen peroxide has become an extremely important tool in 

controlling fire blight in both organic apples and pears. 

Subcommittee Vote:

Motion to remove hydrogen peroxide from §205.601(a) of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Jesse Buie

Seconded by: Harriet Behar

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

Soaps, ammonium

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: 205.601(d) As animal repellents—Soaps, ammonium—for use as a large animal repellant 

only, no contact with soil or edible portion of crop. 

Technical Report: 1996 TAP; 2019 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022 

Subcommittee Review:

Ammonium soaps are used as animal repellents to protect organically produced crops from unwanted 

browsing, primarily from deer and rabbits. USDA organic regulations allow ammonium soaps as a 

"synthetic substance allowed for use in organic crop production" at 7 CFR 205.601.

Ammonium soaps are manufactured by hydrolysis of fats (triglycerides) with an alkaline source in a 

saponification process. In this process, the base reacts with the fatty ester to break the ester linkages, 

resulting in the formation of a salt with the cation of the base and the carboxylate anion that remains at 

the end of the hydrolysis. A wide range of fats may be used in the saponification process, including both 

plant and animal fats. Because of the relative abundance of fats and their low cost, most soaps are 

produced by the saponification of natural fats. Ammonium cations also exist in nature and play an 

important role in the metabolic pathways of a range of organisms , as well as being a key component of 

the nitrogen cycle. Soaps, however, do not naturally exist in nature but are manufactured.

Ammonium soaps are permitted by the Canadian General Standards Board Permitted Substances List - 

Ammonium soaps are listed in the CAN/CGSB-32.311-2015 - Organic production systems - permitted 

substances lists.

Studies conducted by the EPA estimate that ammonium soaps will undergo rapid degradation in the 

environment, primarily through microbial metabolism, yielding an environmental half-life of less than 

one day. Interesting to note that the toxicological profile of the substance differs based on the 

environment in which it is located. They are regarded as having low toxicity to terrestrial organisms, 

NOSB October 2019 proposals and discussion documents Page 82 of 230
with little impact to mammals and avian animals. The EPA has placed them in Toxicity Category IV, the 

lowest available classification. They are, however, moderately toxic in aquatic environments. 

Ammonium soaps have been classified as "highly toxic" to crustaceans by the EPA. Due to the potential 

toxicity to aquatic environments, ammonium soap repellent product labels stipulate "This product may 

be hazardous to aquatic invertebrates. Do not apply to water bodies such as ponds or creeks.

The EPA has given ammonium soaps the lowest possible toxicity classification (Toxicity Category IV). 

They have also concluded that the oral intake of dangerous levels of the substance is highly unlikely due 

to the recognizable and undesirable soap taste. Despite the low toxicity of ammonium soaps there are 

some health risks. They are primarily irritation-based. Occasional skin irritation upon prolonged 

exposure has been reported as potential problems with direct exposure in the eye.

There are some alternative methods that make the use of ammonium soaps unnecessary. They include 

population control of animals, alteration of habitat or physical barriers. As such, fencing is widely 

acknowledged as the most effective means of preventing crop damage from unintended browsing.

There are also natural (non-synthetic) substances which may be used in place of ammonium soaps. 

These all to have similar limitations to the soaps and include fear-based area repellents such as coyote 

urine, smell-based area repellents such as human hair and contact repellents that include capsaicin and 

black pepper oil.

There were approximately 10 comments all supporting the continued listing of ammonium soaps on the 

National List of Allowed and Prohibited Substances. No comments for removal were received.

Subcommittee Vote: 

Motion to remove soaps, ammonium, from §205.601 of the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7CFR205.600(b): NA

Motion by: Rick Greenwood

Seconded by: Emily Oakley

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

Oils, horticultural—§205.601(e)

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: 205.601(e) As insecticides (including acaricides or mite control). (7) Oils, horticultural—

narrow range oils as dormant, suffocating, and summer oils.

Technical Report: 1995 TAP; 2019 TR 

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation – 

deferred; 06/2006 sunset recommendation; 10/2010 sunset recommendation; 10/2015 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review:

Horticultural oils have widespread use in organic fruit and vegetable production. They can be used in 

nearly every season and may be used alone or in mixes that include other nutrient or pest control 

products. Oils may be used for control of multiple plant diseases as well as acaricides, miticides, and 

NOSB October 2019 proposals and discussion documents Page 83 of 230
insecticides. According to the 2018 technical report (TR), oils have different modes of action on insects, 

mites and plant pathogens. They target multiple sites and not specific receptors and thus do not act like 

most synthetic insecticides. This action also helps to prevent resistance to their action. The multiple 

actions include smothering insect eggs by preventing atmospheric gas exchange, softening or disrupting 

insect cuticles, interfering with molting, as well as altering behaviors such as egg laying.

Horticultural oils may be called by many different names; however, the 2018 TR generally refers to them 

as petroleum-derived spray oils (PDSO’s) or mineral oils. Their use has increased and has been refined 

over the last century. Recognition that different fractions of oils have higher efficacy for pest control 

and that the range of phytotoxic effects on the plant goes from none to high depending on the fraction 

used led to the selection of a narrow range of oils exhibiting the dual characteristics of being effective 

against pests and non-toxic to plants. They are often classified by boiling point, although modern 

terminology may refer to many other characteristics such as chain length and chemical structure (2018 

TR).

Most PDSOs are produced from the extraction, distillation, and further refinement of petroleum. The 

2018 TR describes in detail the potential processes by which crude petroleum may be transformed to a 

narrow range horticultural oil. In general, the crude petroleum may be converted chemically by either 

catalytic or thermal methods. Once the oils are converted to a certain fraction, additional chemical 

treatments are applied to the distillates to remove phytotoxic compounds, such as sulfur, while keeping 

compounds toxic to pests and diseases. Additionally, the 2018 TR states horticultural oils are often 

formulated with wetting agents or surfactants that allow them to be mixed and diluted with water. Most 

spray oils in the United States contain a non-ionic surfactant dissolved in the oil concentrate at a 

concentration of 0.35 percent for citrus use and 0.5 percent for deciduous use.

The exploration and extraction of petroleum has a number of environmental effects that include land 

use issues, spills, emissions, pipeline and infrastructure construction, among others. However, once the 

oil is refined and applied as a pest control material, the environmental impact of these oils decreases. 

The EPA exempts petroleum oils, or mineral oil, from the requirement of a tolerance when applied to 

growing crops [40 CFR 180.905]. The 2018 TR cites a number of studies that show that actual 

persistence in the field is highly variable and depends on many factors including temperature, 

precipitation, sunlight, how the oil is applied, and droplet size. Soil biota degrade these oils over time 

with the amount of time necessary for degradation dependent on many environmental factors. Various 

grasses and legumes may also be an effective means of removing petroleum hydrocarbons from the soil. 

The effect of spray oils on non-target beneficial organisms varies based on the mobility of the organism, 

its stage of development, and its ability to reinvade after the oil application (2018 TR). The timing of the 

oil application may also alter the effects on beneficial organisms. For example, dormant applications of 

oil may be applied before beneficial organisms become active. Even where oil is applied repeatedly and 

in the non-dormant season, excellent biocontrol may still be achieved in organic systems. In general, 

non-dormant application rates are lower than dormant rates in order to prevent plant phytotoxicity. 

These lower rates may also limit the negative effects on biocontrol agents. Various studies have 

confirmed that the use of oils is compatible with integrated pest management systems (2018 TR).

Horticultural oils form the basis for many organic pest control systems. They may prevent the need for 

higher toxicity insecticides and keep pest populations below economic thresholds. They are widely used 

in organic tree fruits, traditionally in the dormant season, and more recently, throughout the growing 

season. They may be used alone or in combination with other materials - the use of oil in these 

combinations may help increase the activity of the other material through the “spreading” action of the

oil in addition to the pest control effect of the oil itself. 

NOSB October 2019 proposals and discussion documents Page 84 of 230
Materials such as kaolin, botanical insecticides and plant-based oils may also be alternative to oils. 

Kaolin may be effective in certain cases but does not have the spectrum of activity that oils do. 

Botanical insecticides may disrupt biocontrol programs. Other plant-based oils may be alternatives to 

petroleum-based oils, however, they are not widely used and may not be widely available. The 2018 TR 

notes a number of alternatives and cites one study that showed that castor, cottonseed, and linseed oils 

had comparable or better activity than petroleum oils against scales, but the vegetable oils were also 

more phytotoxic to the plants. Some studies show that plant-based oils may be superior to PDSO’s in 

pest controls, while others indicate lower efficacy. 

Biopesticides may also have efficacy against target pests. These include a number of different fungi, 

bacteria and viruses such as codling moth granulosis virus, Chromobacterium subtsuga, and Bacillus 

thuringiensis (Bt). Oils may target a variety of pests while these various biopesticides either target a 

single pest species or a limited range of pest species. Additionally, these biocontrol agents may be 

applied at different timings than oils and may work better when used in conjunction with oils rather 

than as alternatives (2018 TR). 

Previous sunset reviews included discussions around whether vegetable oils could serve as a natural 

replacement for the horticultural oils. During those discussions it was discovered that vegetable oils 

contained synthetic emulsifiers (mainly derived from a petroleum base), that if excluded, would prevent 

the oils from working properly. Both vegetable and horticultural oils require the addition of emulsifiers

to allow them to stay in suspension when added to water for application to the targeted crop. It was 

also determined that the vegetable oils would not control certain pests adequately compared to the 

horticultural spray oils. 

In past sunset reviews there has been overwhelming support for the continued listing of this material. 

Organic stakeholders provided a clear message to the full NOSB that this material remains a necessary 

tool in organic crop production and in fact has increased in use due to the recent growth of organic 

production. It was also pointed out during public comment that these oils are allowed for use worldwide by most organic certifying bodies for use in organic crop production.

Public comments during the Spring 2019 NOSB meeting echoed earlier comments. Many commenters 

noted the extensive benefits and need for these oils. One commenter noted that there is no known 

alternative for control of bugs in soybean fields. Another noted that while other types of oils are 

available, they will not work in place of horticultural spray oils. They continued by saying that other oils, 

such as fish or vegetable oils, can be phytotoxic to the foliage or fruit/crop itself and can have 

compatibility issues with other materials used in organic production. One comment was received asking 

for an annotation that would protect workers from inhalation hazards and nontarget arthropods from 

harm and if that annotation is not possible that the oils should be delisted. Other than that comment, 

there was broad support for the relisting of horticultural oils.

Subcommittee Vote:

Motion to remove horticultural oils from §205.601(e) of the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Steve Ela

Seconded by: Dave Mortenson

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

NOSB October 2019 proposals and discussion documents Page 85 of 230
Oils, horticultural—§205.601(i)

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: 205.601(i) As plant disease control. (7) Oils, horticultural—narrow range oils as dormant, 

suffocating, and summer oils.

Technical Report: 1995 TAP; 2019 TR 

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation – deferred; 

06/2006 sunset recommendation; 10/2010 sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review:

Horticultural oils have widespread use in organic fruit and vegetable production. They can be used in 

nearly every season and may be used alone or in mixes that include other nutrient or pest control 

products. Oils may be used for control of multiple plant diseases as well as acaricides, miticides, and 

insecticides. According to the 2018 technical report (TR), oils have different modes of action on insects, 

mites and plant pathogens. They target multiple sites and not specific receptors and thus do not act like 

most synthetic insecticides. This action also helps to prevent resistance to their action. The multiple 

actions include smothering insect eggs by preventing atmospheric gas exchange, softening or disrupting 

insect cuticles, interfering with molting, as well as altering behaviors such as egg laying.

Horticultural oils may be called by many different names; however, the 2018 TR generally refers to them 

as petroleum-derived spray oils (PDSO’s) or mineral oils. Their use has increased and has been refined 

over the last century. Recognition that different fractions of oils have higher efficacy for pest control 

and that the range of phytotoxic effects on the plant goes from none to high depending on the fraction 

used led to the selection of a narrow range of oils exhibiting the dual characteristics of being effective 

against pests and non-toxic to plants. They are often classified by boiling point, although modern 

terminology may refer to many other characteristics such as chain length and chemical structure (2018 

TR).

Most PDSOs are produced from the extraction, distillation, and further refinement of petroleum. The 

2018 TR describes in detail the potential processes by which crude petroleum may be transformed to a 

narrow range horticultural oil. In general, the crude petroleum may be converted chemically by either 

catalytic or thermal methods. Once the oils are converted to a certain fraction, additional chemical 

treatments are applied to the distillates to remove phytotoxic compounds, such as sulfur, while keeping 

compounds toxic to pests and diseases. Additionally, the 2018 TR states horticultural oils are often 

formulated with wetting agents or surfactants that allow them to be mixed and diluted with water. Most 

spray oils in the United States contain a non-ionic surfactant dissolved in the oil concentrate at a 

concentration of 0.35 percent for citrus use and 0.5 percent for deciduous use.

The exploration and extraction of petroleum has a number of environmental effects that include land 

use issues, spills, emissions, pipeline and infrastructure construction, among others. However, once the 

oil is refined and applied as a pest control material, the environmental impact of these oils decreases. 

The EPA exempts petroleum oils, or mineral oil, from the requirement of a tolerance when applied to 

growing crops [40 CFR 180.905]. The 2018 TR cites a number of studies that show that actual 

persistence in the field is highly variable and depends on many factors including temperature, 

precipitation, sunlight, how the oil is applied, and droplet size. Soil biota degrade these oils over time 

NOSB October 2019 proposals and discussion documents Page 86 of 230
with the amount of time necessary for degradation dependent on many environmental factors. Various 

grasses and legumes may also be an effective means of removing petroleum hydrocarbons from the soil. 

The effect of spray oils on non-target beneficial organisms varies based on the mobility of the organism, 

its stage of development, and its ability to reinvade after the oil application (2018 TR). The timing of the 

oil application may also alter the effects on beneficial organisms. For example, dormant applications of 

oil may be applied before beneficial organisms become active. Even where oil is applied repeatedly and 

in the non-dormant season, excellent biocontrol may still be achieved in organic systems. In general, 

non-dormant application rates are lower than dormant rates in order to prevent plant phytotoxicity. 

These lower rates may also limit the negative effects on biocontrol agents. Various studies have 

confirmed that the use of oils is compatible with integrated pest management systems (2018 TR).

Horticultural oils form the basis for many organic pest control systems. They may prevent the need for 

higher toxicity insecticides and keep pest populations below economic thresholds. They are widely used 

in organic tree fruits, traditionally in the dormant season, and more recently, throughout the growing 

season. They may be used alone or in combination with other materials - the use of oil in these 

combinations may help increase the activity of the other material through the “spreading” action of the 

oil in addition to the pest control effect of the oil itself. 

Materials such as kaolin, botanical insecticides and plant-based oils may also be alternative to oils. 

Kaolin may be effective in certain cases but does not have the spectrum of activity that oils do. 

Botanical insecticides may disrupt biocontrol programs. Other plant-based oils may be alternatives to 

petroleum-based oils, however, they are not widely used and may not be widely available. The 2018 TR 

notes a number of alternatives and cites one study that showed that castor, cottonseed, and linseed oils 

had comparable or better activity than petroleum oils against scales, but the vegetable oils were also 

more phytotoxic to the plants. Some studies show that plant-based oils may be superior to PDSO’s in 

pest controls, while others indicate lower efficacy. 

Biopesticides may also have efficacy against target pests. These include a number of different fungi, 

bacteria and viruses such as codling moth granulosis virus, Chromobacterium subtsuga, and Bacillus 

thuringiensis (Bt). Oils may target a variety of pests while these various biopesticides either target a 

single pest species or a limited range of pest species. Additionally, these biocontrol agents may be 

applied at different timings than oils and may work better when used in conjunction with oils rather 

than as alternatives (2018 TR). 

Previous sunset reviews included discussions around whether vegetable oils could serve as a natural 

replacement for the horticultural oils. During those discussions it was discovered that vegetable oils 

contained synthetic emulsifiers (mainly derived from a petroleum base), that if excluded, would prevent 

the oils from working properly. Both vegetable and horticultural oils require the addition of emulsifiers 

to allow them to stay in suspension when added to water for application to the targeted crop. It was 

also determined that the vegetable oils would not control certain pests adequately compared to the 

horticultural spray oils. 

In past sunset reviews there has been overwhelming support for the continued listing of this material. 

Organic stakeholders provided a clear message to the full NOSB that this material remains a necessary 

tool in organic crop production and in fact has increased in use due to the recent growth of organic 

production. It was also pointed out during public comment that these oils are allowed for use worldwide by most organic certifying bodies for use in organic crop production.

Public comments during the Spring 2019 NOSB meeting echoed earlier comments. Many commenters 

noted the extensive benefits and need for these oils. One commenter noted that there is no known 

NOSB October 2019 proposals and discussion documents Page 87 of 230
alternative for control of bugs in soybean fields. Another noted that while other types of oils are 

available, they will not work in place of horticultural spray oils. They continued by saying that other oils, 

such as fish or vegetable oils, can be phytotoxic to the foliage or fruit/crop itself and can have 

compatibility issues with other materials used in organic production. One comment was received asking 

for an annotation that would protect workers from inhalation hazards and nontarget arthropods from 

harm and if that annotation is not possible that the oils should be delisted. Other than that comment, 

there was broad support for the relisting of horticultural oils.

Subcommittee Vote:

Motion to remove horticultural oils from §205.601(i) of the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Steve Ela

Seconded by: Harriet Behar

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

Pheromones

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: 205.601(f) As insect management. Pheromones.

Technical Report: 1995 TAP; 2012 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review:

Pheromones are volatile chemicals produced in nature by a given species to communicate with other 

individuals of the same species to affect their behavior. Pheromones are produced naturally by many 

organisms and are synthetically produced for use in agriculture. Insect pheromones are generally 

comprised of very specific esters, that alone, or in combination, create a species-specific communication 

system. Pheromones may be released from various types of dispensers into the surrounding air. Inert 

ingredients may be used as part of the formulation process but generally do not contact crops since they 

are contained within the dispensers. Pheromones are considered generally non-toxic and have a low 

persistence in the environment. 

Pheromones are used by organic (and many conventional) crop producers and are especially important 

for organic tree fruit production. Pheromones are used by growers in a variety of ways such as 

monitoring insect presence and population density, mass trapping, ‘attract and kill’ systems, and for use 

in mating disruption or confusion. 

The use of pheromones to attract insects to traps has long been used as a means of monitoring 

populations, determining whether controls need to be applied, and infer the timing of controls 

applications. Varying types of dispensers are impregnated with the pheromone and then placed in some 

sort of monitoring trap. Trapping can field check insect development models as well as be used to 

determine when a threshold has been reached that might require further action by a farmer. Mass 

trapping using pheromones as an attractant can also be used to help in reducing the overall numbers of 

NOSB October 2019 proposals and discussion documents Page 88 of 230
an insect pest. A variant of mass trapping is the attract and kill system. Rather than trapping the insect, 

these systems use the synthetic pheromone as an attractant to get the insect to come into contact with 

an insecticide.

Mating disruption/confusion uses a synthetic pheromone to saturate a targeted area. The male of the 

targeted species is unable to differentiate between the pheromone released by the female and that 

applied by dispensers. This can cause the male to become confused and disoriented and thus unable to 

locate the species female for mating. Normally in organic crop production these pheromones are 

dispersed for use via a passive or active pheromone dispenser (including traps and lures). Some forms of 

passive dispensers are pheromone-impregnated polymer spirals, ropes, coils, twist ties, or tubes. The 

use of wires, clips, or circular tubes allows these pheromone dispensers to be placed directly in the 

intended area of usage. Active dispensers, commonly called puffers, distribute a larger amount of 

pheromone on a programmed schedule. They are usually used at lower densities than passive 

dispensers and can be programmed to only release pheromone when the target insect might be active. 

As the 2012 technical report notes, while pheromones are produced naturally by insects and other 

organisms, they are difficult to isolate in sufficient quantities for commercial production. Thus, most 

commercially used pheromones are synthetically produced and attempt to replicate the natural 

pheromone. The synthesis of the pheromones is complex and normally involves a number of conversion 

steps.

The TR further cites various studies showing that insect pheromones are generally comprised of very 

specific esters. These esters vary in carbon chain length. The primary components of sex pheromones 

(esters) are the most critical part of the chemical complex, but are reliant on the presence or absence of 

secondary components, which greatly affect an insect’s response sequence. 

During past reviews there has been concern raised over the inerts used in pheromones because they do 

include known irritants, sensitizers, and allergens. The 2012 TR mentions that some compounds could 

potentially be linked to asthma, cancer, or endocrine disruption. However, under the current use of 

pheromones it is not believed that they would release enough volume to leave any kind of residue on 

the agricultural crops being treated. It also states that dissipation takes place via volatilization and 

degradation, rapidly into the environment. 

In past reviews, some concerns were raised around the use of “encapsulated pheromones” (those 

concerns mentioned harm to honey bees and concerns over aerial applications). These involve small 

pheromone containing capsules that might be applied in water or by air and could have direct crop 

contact. However, use of these forms of pheromones has not generally reached commercial 

application. 

The 2012 TR notes that based on low observed toxicity in animal testing, and expected low exposure to 

humans, there is no risk to human health expected from the use of pheromones. EPA data shows that 

no human health concerns had been reported in the ten years prior to the TR.

Pheromones continue to be an integral and highly used component of organic agriculture. Their use in 

trapping and monitoring provides a basis for integrated pest management and helps to ensure that 

other pest control materials are only applied where and when needed. For certain pests in organic 

systems their use in mating disruption may be the only viable control option and in other systems their 

use precludes the need for more disruptive control options.

NOSB October 2019 proposals and discussion documents Page 89 of 230
Public comments from previous sunset reviews have been strongly supportive of the relisting of 

pheromones. Other commenters have noted that their delisting would lead to the loss of many acres of 

organic tree fruits. Comments noted that the use of pheromones in organic crop production has 

continued to increase, as various formulations have been developed for specific target species.

Public comments received during the Spring 2019 NOSB meeting were in favor of relisting pheromones. 

There were many comments noting their widespread use, insect specificity, use in monitoring 

populations, and benign nature. Several commenters did support relisting with the caveat that the 

pheromones are identical to or substantially similar to natural pheromones, in passive dispensers, 

without added toxicants and with only approved inert ingredients. There is currently no annotation for 

pheromones, but comments received indicate that their use generally fits this request. 

Microencapsulated pheromones which might be sprayed and have direct fruit contact have not become 

commercially available. Active dispensers (also known as puffers) are in current use, but act in similar 

fashion to the passive dispensers in terms of fruit contact or type of pheromone used. 

Subcommittee Vote:

Motion to remove pheromones from §205.601(f) of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Steve Ela

Seconded by: Dave Mortenson

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

Ferric phosphate

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: §205.601(h) As slug or snail bait. Ferric phosphate (CAS #s 10045-86-0).

Technical Report: 2004 TAP, 2010 TR, Supplemental TR 2012

Petition(s): 05/2003 , Supplemental Information 02/2005, Petition to remove: 07/2009

Past NOSB Actions: 03/2005 sunset recommendation; 04/2010 sunset recommendation; 10/2012 

recommendation on petition to remove from national list; XX/2016 sunset recommendation

Recent Regulatory Background: Added to National List 09/11/06 71 FR 53299; Renewed 08/03/2011 76 FR 

46595; Renewed 09/12/16 81 FR 8821

Sunset Date: 9/12/2021

Subcommittee Review:

Use

Ferric phosphate is used as a molluscicide for slug and snail suppression. Ferric phosphate accumulates in 

the calcium spherules of slug and snail digestive glands, thereby interfering with calcium metabolism, and 

in turn, disrupting feeding and mucus production. After ingesting ferric phosphate slugs and snails stop 

feeding and death due to starvation will occur three to six days later. Ferric phosphate occurs naturally in 

soil but at considerably lower concentrations than that present in the formulated, baited product. 

Manufacture

Ferric phosphate occurs naturally in the soil; however, to achieve concentrations toxic to molluscs ferric 

phosphate must be supplemented through applications, most often with ferric phosphate formulated with 

a chelating agent. To produce ferric phosphate synthetically, an aqueous iron sulfate solution is mixed with 

an aqueous disodium phosphate solution in a stainless steel boiler. The mixture is heated to 50-70 °C in 

order to precipitate ferric phosphate. The precipitate is filtered from the solution, washed with distilled

NOSB October 2019 proposals and discussion documents Page 90 of 230
water, and dried with hot air. The baited pellets contain approximately 1% by mass of ferric phosphate with 

the remainder of the pellet comprised of a chelating agent and carbohydrate inerts. 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. 

International acceptance by other international certifying bodies

The European Union, the Canadian General Standards Board, The International Federation of Organic 

Agriculture Movement and the Japanese Organic Standard for Organic Plants all list ferric phosphate for use 

as a molluscicide in the protection of plants. 

Environmental/Health Issues

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. Small concentrations of 

ferric phosphate are made available in soil solution when it is solubilized by commonly occurring soil 

microorganisms such as Penicillium radicum. 

Ferric phosphate by itself appears to be less toxic to a range of soil borne organisms (including slugs and 

snails) than when formulated with a chelating agent (EDTA or EDDS for example). The chelating agent 

enhances iron uptake by organisms in general. A number of published studies document that when 

formulated with a chelating agent, the efficacy for control of slugs and snails increases significantly. 

However, the increased efficacy also means its activity on non-target organisms like earthworms, domestic 

animals and humans also increases. The LD50 for ferric phosphate alone is greater than 10,000 mg kg while 

it drops to 80 mg kg when it is formulated with the chelating agents EDTA or EDDS (Ethylene diamine 

tetracetic acid – EDTA and Ethylene diamine disuccinic acid (EDDS). 

Discussion

The 2012 technical review addressed a series of concerns about the biological activity of ferric phosphate 

both in terms of its effectiveness in suppressing slugs and snails as well as its non-target effects on the 

ecology and abundance of soil dwelling organisms. Because the commercial formulations of ferric 

phosphate always included ferric phosphate itself and a chelating agent the NOSB was concerned about the 

effects of the formulated products used by farmers. Specifically, four questions regarding the efficacy of 

ferric phosphate alone and the synergizing effects of chelating agents (EDTA and EDDS) concluding without 

the chelating agent, ferric phosphate did not provide sufficient or consistent suppression of slugs and snails. 

In fact the efficacy was so low that it is hard to see why it would be used for slug and snail suppression 

without the chelating agent. The TR then asked, what risk does the use of ferric phosphate and its 

associated chelating agents pose to soil organisms and water quality. Here the existing data are scant. What 

has been researched (three studies published between 2006 and 2009) indicate a range of responses from 

non-significant to highly significant adverse effects of chelated ferric phosphate on a range of non-target 

organisms. A second technical review was sought and received to underpin this 2018 Sunset review. In that 

technical review, the Crops Subcommittee asked if additional research had been conducted addressing the 

following questions: 1) What new findings have been reported since 2009 that would inform our 

understanding of the influence of ferric phosphate alone and ferric phosphate in combination with 

commonly used chelating agents on the soil micro and macro fauna with particular attention to earthworm 

populations?; 2) To what extent is ferric phosphate used for slug and snail management in organic 

production?; 3) How are the products formulated that are detailed in (2) above?; 4) Since the July 26, 2012 

technical review, have additional studies been conducted documenting the effects of fieldworker exposure 

to ferric phosphate bait handling including inhalation of dust resulting from field applications. The same 

questions were posed to the public with a particular focus on the second question, how widely is ferric

phosphate used?

NOSB October 2019 proposals and discussion documents Page 91 of 230
From the 2018 technical review we learned that little additional research has been conducted since the 

2012 technical review quantifying the soil community response to ferric phosphate. The technical review 

did confirm that commercial formulations routinely include ferric phosphate and a chelating agent. We 

received considerable public comment on ferric phosphate learning that it is seen as an integral part of 

vegetable and fruit pest management and is widely used for slug and snail management in organic systems. 

We heard from some public comments that while a systems-approach is taken to address the slug and snail 

problem, attempts by organic farmers to increase reliance on cover-cropping and decreased tillage can lead 

to increased slug and snail abundance. The Subcommittee recognizes the efficacy of ferric phosphate is 

inextricably linked with the formulation; when formulated with a chelating agent, ferric phosphate 

effectively suppresses slugs and snails, unfortunately, the non-target effects on other soil organisms 

increase as well. 

Vote in Subcommittee: 

Motion to remove ferric phosphate from the National List at §205.605 based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Dave Mortensen

Seconded by: Harriet Behar 

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

Potassium bicarbonate

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: 205.601(i) As plant disease control. (9) Potassium bicarbonate.

Technical Report: 1999 TAP; 2015 TR 

Petition(s): N/A

Past NOSB Actions: 10/1999 NOSB meeting minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022 

Subcommittee Review:

Potassium bicarbonate is a plant disease control material. It is used by organic crop producers to control 

alternaria in cucurbits and cole crops; anthracnose in cucurbits, blueberries, grapes, spinach, and 

strawberries; black dot root rot and early blight in potatoes; sooty blotch and powdery mildew in apples; 

downy mildew in cucurbits, cole crops, grapes, and lettuce; gray mold (Botrytis cinerea) in beans, lettuce, 

and strawberries. These are just a few of the crops and specific diseases it helps to control. It is best suited 

for many of the powdery mildew diseases (TR lines 80-1) and early blight (1999 TAP). It has proven to be an 

important disease control aid in organic crop production.

Potassium bicarbonate is produced by carbonating potassium hydroxide to K2CO3, which is then carbonated 

to KHCO3. Carbonation is accomplished by injecting carbon dioxide gas into an aqueous solution of 

potassium hydroxide. (1999 TAP) 

The 1999 TAP review states that the decomposition products are potassium carbonate, water, and carbon 

dioxide, all of which readily dissipate in the environment. It found this material to be compatible with 

NOSB October 2019 proposals and discussion documents Page 92 of 230
organic crop production, safe, and more environmentally friendly than many of the synthetic alternatives. 

Potassium bicarbonate is a mild respiratory and eye irritant.

During the 2015 sunset review, a limited scope Technical Report (TR) was requested. The TR provided 

possible alternative materials or practices that might replace this material. Bacillus amyliquifaciens strain 

D747, Bacillus subtilis, Bacillus pumilis, gibberellic acid, and Streptomyces griseovirdis and lydicus,

Gliocladium catenulatum, and extracts of giant knotweed are all listed as natural alternatives for numerous 

plant diseases across many crops. Bordeaux mixture, kaolin, lime sulfur and sulfur, hydrogen dioxide, and 

neem extracts are offered as alternatives for both treatment and disease prevention across myriad crops 

and diseases, in addition to a variety of cultural and mechanical practices. Further clarification was sought 

in 2015 from stakeholders using this material to help explain under what conditions or scenarios the 

alternatives might be applied. Organic producers responded that while alternative materials and/or 

practices exist, potassium bicarbonate remains necessary for their particular crop production practices. 

Potassium bicarbonate is an important tool in powdery mildew resistance management. In addition to its 

efficacy on powdery mildew, stakeholders said its unique mode of action helps control other diseases under 

certain conditions or scenarios better than the alternative materials or practices. 

There was continued support for the continued listing of this material in 2015. One commenter was 

concerned that this material does not fit into any of the categories under §6517(c)(1)(B)(i) of OFPA. Others 

noted its extensive listing in Organic Systems Plans. Based on extensive public comment, the NOSB 

continued to find potassium bicarbonate compliant with OFPA criteria and did not recommend removal 

from the National List.

As part of the Spring 2019 public meeting, the Crops Subcommittee asked about efficacy of alternatives and 

the continued need for potassium bicarbonate. Written and oral testimony expressed continued support 

for this material, stating that it is used to control a number of diseases across a wide range of crops, 

including strawberries, cucurbits, tomatoes, and fruit trees. It is used in field, high tunnel, and greenhouse 

applications, and it is employed by some as part of a material rotation. One commenter expressed that it 

does not fit any OFPA categories of allowable synthetics.

Subcommittee vote

Motion to remove potassium bicarbonate from §205.601 (i) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Emily Oakley

Seconded by: Dave Mortenson

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

Magnesium Sulfate

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: 205.601(j) As a plant or soil amendment. (6) Magnesium sulfate—allowed with a documented 

soil deficiency.

Technical Report: 1995 TAP; 2011 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 sunset recommendation

NOSB October 2019 proposals and discussion documents Page 93 of 230
Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022 

Subcommittee Review:

Magnesium sulfate is used to correct for magnesium soil deficiencies and helps to improve the uptake of 

nitrogen and phosphorus by crops, helps seeds germinate, increases chlorophyll production, aids in the 

production of flowering, and is vital in maintaining crop growth and yield.

Magnesium sulfate can be obtained from naturally occurring sources (kieserite or epsomite open-pit mines) 

or can be manufactured by a chemical process. Mineral forms of magnesium sulfate are dehydrated, 

purified, and reacted with sulfuric acid to create the synthetic version of magnesium sulfate. Historically, 

there have been no commercially available products containing mined, raw mineral magnesium sulfate in 

bulk quantities suitable for agriculture. For this reason, the production of synthetic magnesium sulfate has 

been necessary.

As stated in the 2011 Technical Report (TR) (lines 320-23): “If applied as a foliar feed in recommended 

doses (assuming also that a magnesium deficiency has been documented), magnesium sulfate would not be 

expected to produce toxic effects. However, if too much magnesium sulfate is added to the soil, or if the 

substance is added when a magnesium deficiency has not been determined, the uptake of other important 

nutrients will be affected.” The TR goes on to state that when used properly, it is unlikely to cause 

environmental or human health harm.

During the 2015 review, the Crops Subcommittee asked stakeholders if non-synthetic magnesium sulfate is 

available in the marketplace. Public comment indicated that the only form of non-synthetic magnesium 

sulfate that has been reviewed is potassium magnesium sulfate, or langbeinite; however, this material is 

not a reliable alternative because it is only available in limited quantities, and it is impossible to determine 

upon purchase whether langbeinite is synthetic or non-synthetic. There was substantial public comment in 

support of relisting magnesium sulfate. It is actively used by stakeholders and continues to be considered 

necessary to the production of fruit and vegetables. One commenter opposed the relisting, stating that 

nonsynthetic magnesium sulfate is available as langbeinite and dolomite; however, langbeinite is 

constrained by supply and classification issues. While dolomite can be used to treat a magnesium 

deficiency, the TR states that it is not as effective as magnesium sulfate and was not referenced by other 

commenters as a viable alternative. No significant new issues were raised, and the NOSB continued to find 

magnesium sulfate compliant with OFPA criteria and did not recommend removal from the National List.

As part of the Spring 2019 public meeting, the Crops Subcommittee asked if non-synthetic magnesium 

sulfate is available and about growers’ experiences using non-synthetic dolomite. Written and oral 

testimony expressed continued support for this material, stating that it is important in high tunnels and 

greenhouses as well as fruit tree production. Some growers commented that dolomite is not a suitable 

substitute in all cases as it cannot be used in high pH soils nor as a foliar application. It was also noted that 

there are few non-synthetic products on the market. Magnesium sulfate is also used in high pH soils when 

sulfur is needed but growers do not want to increase the pH. It is used alone and in blended products. 

Another commenter noted that use of magnesium sulfate should not take the place of soil building 

practices. 

NOSB October 2019 proposals and discussion documents Page 94 of 230
Subcommittee Vote: 

Motion to remove magnesium sulfate from §205.601 (j) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Emily Oakley

Seconded by: Asa Bradman

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

Hydrogen chloride

§205.601 Synthetic substances allowed for use in organic crop production.

Reference: §205.601(n) Seed preparations. Hydrogen chloride (CAS # 7647-01-0)—for delinting cotton 

seed for planting.

Technical Report: 2003 TAP, 2014 Limited Scope TR

Petition(s): Hydrogen Chloride 10/30/02

Past NOSB Actions: 05/2004 NOSB recommendation for National List; 11/2009 sunset recommendation; 

4/2015 recommendation

Recent Regulatory Background: 

Added to National List 09/11/06 (71 FR 53299); Renewed 08/03/2011 (76 FR 46595) 

Renewed 09/12/16 (81 FR 8821)

Sunset Date: 9/12/2021

Subcommittee Review:

Use

Hydrogen chloride (2HCl) (CAS# 7647-01-0) forms a strong acid used for delinting cotton seed for planting. 

Hydrogen chloride is a liquid anhydrous hydrogen gas that is vaporized and then sprayed on cotton seeds 

after the ginning process. The gas mixes with the moisture in the seeds, resulting in acidic properties under 

which the lint on the seeds becomes weakened and is buffed off before planting. Because many fibers are 

attached to the seeds even after ginning, delinting improves handling (i.e., flowability ) for subsequent 

planting by mechanized equipment.

Manufacture

There are several methods used to produce hydrogen chloride. It can be synthesized directly or as 

a byproduct from manufacturing other chlorinated or fluorinated compounds.

International acceptance

Canadian General Standards Board Permitted Substances: Not listed. 

CODEX Alimentarius: Not Listed

European Economic Community (EEC) and India (NPOP): Hydrogen chloride not listed. Hydrochloric acid is 

listed for gelatin production and cheese processing (EEC)

Japan Agricultural Standard (JAS) for Organic Production: Not listed 

International Federation of Organic Agriculture Movements (IFOAM): Not 

listed.

Ancillary substances

None

NOSB October 2019 proposals and discussion documents Page 95 of 230
Impacts on health and the environment

Hydrogen chloride gas and subsequently produced hydrochloric acid are strongly corrosive materials 

and can cause skin burns, severe respiratory damage, circulatory system failure and death. Spills during 

manufacture or handling can injure workers or locally damage the environment.

Discussion

Hydrogen chloride for delinting cottonseed was recommended by the NOSB to be added to the National 

List in April 2004, and has been recommended each time it has subsequently been reviewed. However, 

hydrogen chloride, and the subsequently formed hydrochloric acid, are very corrosive materials and pose 

potential environmental and health threats if not handled properly. The 2014 limited scope TR identified 

several alternative, nonsynthetic delinting processes under development that were not commercially 

available at that time. The decision to relist was based on the lack of viable alternatives and the hope 

“that mechanical or other delinting processes are available to organic cotton growers by the next sunset 

review, so this very corrosive acid can be removed from the National List.” The 2014 limited TR included 

information (see Table 1 below) describing several alternatives to hydrogen chloride, and also referenced 

a mechanical cottonseed delinter under review by the USDA Agricultural Research Service. In follow-up 

to public comments from the Spring 2019 meeting, the Crops Subcommittee reached out to the Texas 

Organic Cotton Marketing Cooperative and Dr. Jane Dever, a professor and cotton breeder at Texas A&M 

for additional clarification on mechanical seed cleaning methods, obstacles to adopting non-chemical 

methods, and challenges addressing seed dormancy. 

Overall, comments and discussion reviewed for the Spring 2019 NOSB meeting and subsequent information 

NOSB October 2019 proposals and discussion documents Page 96 of 230
confirms that circumstances since 2014 are unchanged. Although progress has been made, viable 

alternatives to hydrogen chloride are not yet available. A key challenge is the small size of the U.S organic 

production market which does not economically incentivize companies to develop organic-specific 

technologies. Spring 2019 public comments were universally supportive of relisting hydrogen chloride as 

essential, and asserted that failure to do so would irreparably harm the U.S. organic cotton industry. 

Allowing the limited use of hydrogen chloride for seed preparation accrues economic and environmental 

benefits by supporting domestic organic cotton production and avoiding associated impacts of heavy 

pesticide use on conventional cotton. The need for additional specialized research to support alternatives

to hydrogen chloride, a caustic and potentially harmful material, were emphasized, and is supported by the 

Crops Subcommittee.

 

Subcommittee Vote:

Motion to remove hydrogen chloride for delinting cotton seed for planting based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or §205.601(n) seed preparations if applicable: NA 

Motion by: Steve Ela 

Seconded by: Harriet Behar

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

Ash from manure burning

§205.602 Nonsynthetic substances prohibited for use in organic crop production.

Reference: 205.602(a) Ash from manure burning.

Technical Report: none

Petition(s): 2014

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation, 10/2015 sunset recommendation; 4/2016 NOSB formal recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review:

Use: In some areas of nonorganic agriculture, the burning of manure to create an ash is used to lessen the 

volume of material (manure) transported to a field for fertilizer and to recover some of the nutrients in a 

more concentrated form (phosphorus, calcium, potassium and magnesium). The ash can then be used as a 

fertility input that is high in these nutrients. Large scale biochar manufacturing facilities claim that CAFOs 

can benefit from this manufacturing process, to lessen the impact of the volume of manure they need to 

dispose of from their facilities. This ash from manure has also been touted as a feed ingredient for 

livestock. The NOP organic standards do not allow re-feeding of manure to organic livestock. 

Manufacture: Manure can be thermally decomposed through combustion to produce this ash.

International: Canadian standards do not allow ash from manure burning to be used on organic crops. The 

EU does not allow manure from confined animal operations to be used on organic crops.

NOSB October 2019 proposals and discussion documents Page 97 of 230
Summary of Public Comment:

The vast majority of public comment addressing this material agreed with a continued listing as a 

prohibited material. However, one commenter discussed the benefits of controlled pyrolysis burning to 

create a manure-based biochar as being a good way to avoid the negative effects of nutrient leaching and 

other issues dealing with large volumes of raw manure. This commenter discussed the special property of 

heavy metal soil remediation in contaminated soils of manure-based biochars, over plant-based biochars. 

This was the only comment that answered the Subcommittee’s question in our first review: 

“Does ash from manure burning supply nutrients or other benefits that cannot be obtained from any other 

material?”

Discussion:

In April 2016, the NOSB responded to a petition to allow ash from manure burning with the following 

annotation: “except where the combustion reaction does not involve the use of synthetic additives and is 

controlled to separate and preserve nutrients”. The petitioner stated they source manure from 

Concentrated Animal Feeding Operations (CAFOs) and use a staged thermochemical reactor to extract 

minerals from their poultry manure source. The NOSB stated the following to support their 

recommendation to keep this material, as listed, as a prohibited nonsynthetic:

“Ash from manure burning was placed on §205.602 based on its incompatibility with organic production: 

“Burning these materials is not an appropriate method to recycle organic wastes and would not be 

considered a proper method in a manuring program because burning removes the carbon from these 

wastes and thereby destroys the value of the materials for restoring soil organic content. Burning as a 

disposal method of these materials would therefore not be consistent with section 2114(b)(1) of the OFPA (7 

U.S.C. 6513(b)(1)).” (Preamble to proposed rule, December 16, 1997. 62 FR 241: 65874)”

The USDA organic regulations require “soil-building” as a basic foundational principle, to improve soil tilth, 

water retention, nutrients and carbon sequestration. “§205.203 (c) The producer must manage plant and 

animal materials to maintain or improve soil organic matter content....” 

Soil microbiological life increases when provided with carbon-based sources containing a variety of 

nutrients, and extraction of nutrients while destroying others (such as nitrogen) does not meet either the 

letter, nor spirit of the USDA organic law or regulations.

The current crop subcommittee agrees with the previous NOSB recommendation, and prefers manure 

retain its full carbon and nutrient content, when used as a fertility input on organic land.

Subcommittee Vote:

Motion to remove ash from manure burning from §205.602 of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Harriet Behar 

Seconded by: Jesse Buie

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

NOSB October 2019 proposals and discussion documents Page 98 of 230
Sodium fluoaluminate (mined)

§205.602 Nonsynthetic substances prohibited for use in organic crop production.

Reference: 205.602(g) Sodium fluoaluminate (mined).

Technical Report: none

Petition(s): N/A

Past NOSB Actions: 05/1996 NOSB meeting minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022 

Subcommittee Review:

Sodium fluoaluminate (Na3AlF6)—also known as “sodium fluoroaluminate,” “aluminum sodium fluoride,” 

“trisodium hexafluoroaluminate,” and “cryolite”—is a colorless to white halide mineral. It occurs in a large 

deposit at Ivigtut, Greenland, and in small amounts in Spain, Colorado, U.S., and elsewhere. It is used as a 

solvent for bauxite in the electrolytic production of aluminum and has various other metallurgical 

applications, and it is used in the glass and enamel industries, in bonded abrasives as a filler, and in the 

manufacture of insecticides (see www.britannica.com/science/cryolite for information on cryolite). Sodium 

fluoaluminate is also produced synthetically.

According to an EPA memorandum dated March 16, 2011, on the subject of “Cryolite. Human Health 

Assessment Scoping Document in Support of Registration Review” (link to document available via 

https://fluoridealert.org/researchers/pesticide/cryolite/): 

Cryolite [sodium aluminofluoride or sodium aluminum fluoride or sodium hexafluoroaluminate] is 

an insecticide used to control a variety of pests including various weevils, leaf rollers, various 

moth and worm species, and grape skeletonizers. Cryolite can be used on a wide array of 

agricultural crops including grapes (wine, table, raisin), cole crops, citrus, berries, tomatoes, 

cucumber, lettuce, and many types of ornamentals. Formulations include dusts, wettable 

powders, water dispersible granules, and baits/solids. Some formulations can contain as much as

96 percent active ingredient by weight. A recent evaluation of cryolite use indicates almost 2 

million pounds per year are applied on about 300,000 acres, most of which are on grapes (92% of 

total pounds applied and 96% of treated acres) (Prieto, 2010). Use in California accounts for the

vast majority of cryolite use (97%). In agriculture, groundboom, airblast, and aerial applications 

are typical but applications as a pure dust can also occur which may dictate other specialized 

forms of equipment being used. Applications to ornamentals may also be made using handheld 

equipment such as low and high pressure handgun sprayers and backpack sprayers. There are no 

cryolite containing products that appear to be marketed for sale to homeowners nor are there 

products which appear to be labeled for use by professionals in the residential marketplace (i.e., 

outdoors or indoors). Maximum application rates for most agricultural crops are in the 5 to 16 

pounds product per acre range while some uses, especially on ornamentals can be higher (i.e., up 

to 30 lb/A using a 96% formulation).

The potential toxicity of sodium fluoaluminate/cryolite is due to the release of fluoride into the 

environment due to the dissociation of cryolite into fluoride. The EPA memorandum cited above references 

NOSB October 2019 proposals and discussion documents Page 99 of 230
a number of animal toxicological studies on this substance; other studies related generally to fluoride 

toxicity are also referenced, since fluoride enters the environment in multiple ways—including fluoridated 

water—and therefore can have a cumulative adverse impact on health. 

There were no references to either sodium fluoaluminate or cryolite in the Canadian and European organic 

regulation websites. 

Public Comment from the Spring 2019 NOSB Meeting

There were only a few written comments received regarding sodium fluoaluminate prior to the Spring 2019 

NOSB meeting. All supported continued relisting of this substance as prohibited.

Conclusion

Given the toxicity associated with fluoride pollution in the environment and the multiple sources of such 

pollution, continued prohibition of this substance in organic production seems prudent. 

Additional information requested by Subcommittee

Are there any reasons why the long-standing prohibition on using sodium fluoaluminate in organic 

production should be reconsidered by the NOSB?

Subcommittee Vote:

Motion to remove sodium fluoaluminate (mined) from § 205.602 of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Dan Seitz 

Seconded by: Jessie Buie

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

NOSB October 2019 proposals and discussion documents Page 100 of 230
National Organic Standards Board

Crops Subcommittee Petitioned Material Discussion Document

Paper (Plant Pots and Other Crop Production Aids)

August 15, 2019

Summary of Petition and Petition Addendum for Paper (Plant Pots and Containers): 

The NOSB received a petition in August 2018 for the addition of paper planting pots to the National List: 

§205.601(o) As production aids. Plant pot or growing container—hemp or other paper, without glossy 

or colored inks. 

This material has not been petitioned for inclusion on the National List in the past; however, paper chain 

pots have been historically allowed for the past 12 years by some organic certification agencies under 

the allowance for “Newspaper or Other Recycled Paper” as a mulch or compost feedstock. 

In February 2018, the NOP notified all certifiers that paper chain pots are not allowed in organic 

systems; however, because some certifiers had previously approved their use, NOP allowed a phase-out 

period until the end of the 2018 crop season. The NOP’s decision on this material was based primarily 

on the fact that paper (a synthetic substance) is not included on the National List for uses other than as 

mulch and as compost feedstock. The paper chain pots also contain other synthetic substances, such as 

adhesives. At the October 2018 and April 2019 NOSB meetings, there were numerous oral and written 

public comments requesting a longer time period for allowing these paper pots while the NOSB 

reviewed the petition. The NOSB also formally requested this extension of the NOP in November 2018, 

the NOP agreed to allow the use of paper pots in organic agriculture in late fall 2018, with no time 

restriction, in order to give the NOSB time to review this material. 

Paper pots are used by small and mid-scale farming operations to efficiently transplant vegetable 

seedlings. More information on this transplanting method can be found on these websites: 

http://paper-pot.com/ and http://www.smallfarmworks.com/. The transplanting equipment and paper 

pot chains are imported from a manufacturer in Japan. According to the petition, the Nitten paper chain 

pot system uses paper produced from a non-bleached Kraft pulp, and adhesives. There have been 

synthetic polymers (also called “synthetic fibers” in this document) in small quantities in the paper pots, 

but experiments are taking place to determine if these can be replaced by a natural hemp fiber. The 

petitioner and public comment at the Spring and Fall 2018 NOSB meetings stated this system is unique 

and essential for growers. The alternative would be the much slower and more costly method of hand 

planting individual seedlings. The system is used for closely spaced crops such as onions, beets, baby 

salad, etc. The petition states that similar to newspaper, these pots decompose readily in the soil. 

In addition to the Nitten petitioner, there are numerous other paper pot systems, both to be 

transplanted as single plants and in chains of pots. These other paper pot systems have various 

proportions of synthetic polymer fibers as well as other ingredients, such as cow manure. The 

subcommittee seeks to address all these products in our recommendation. 

The petition states that in addition to information on paper, the 2017 Technical Report (TR) on 

newspaper and other recycled paper addresses the presence of adhesives in recycled paper as well. The 

three adhesives in the Nitten paper chain pots are vinyl-acetate resin (water soluble and stated to be 

leached from the pots before transplanting), ethylene-vinyl-acetate resin, and acrylic acid ester 

copolymer. 

NOSB October 2019 proposals and discussion documents Page 101 of 230
The crops subcommittee has seen paper pots, used as a crop production aid, as another use of paper 

beyond compost feedstocks and mulch, which are allowed under the NOP regulation; however, in order 

to conduct this review, the crops subcommittee requested a July 2019 Technical Report on Paper Pots 

and Containers to determine the extent of synthetic adhesives, synthetic polymer fibers, and other 

additives in paper pots and to determine whether or not they are substantively different than those 

found in paper already allowed as mulch and compost feedstocks (§§ 205.601(b) and 205.601(c)). Pots, 

compost, and mulch all degrade into the soil, and the crops subcommittee believes if the fibers and 

additives are allowed in the other listings for paper, then their use in pots should be allowed as well.

However, since the subcommittee is proposing allowing the use of virgin paper, the subcommittee 

wants to make sure that the annotation does not allow for that virgin paper to include any amount or 

type of synthetic polymer and that those synthetic polymers used in the virgin paper are biobased and 

biodegrade in the soil.

The Technical Review clarified that the additives and synthetic fibers found in a variety of paper pots are 

also found in newspaper and other recycled paper currently allowed for compost feedstock and mulch. 

Other possible additives and synthetic fibers for paper pots that were not mentioned in the petition are 

described in the TR.

Summary of Public Comment: 

Many users of the paper chain pot system provided written and verbal comment to the NOSB at the fall 

2018 and spring 2019 meetings. They spoke in favor of its use due to its efficiency in transplanting, 

particularly in smaller scale production systems. Some certifiers spoke in favor of this material and 

noted that if the paper was torn off the pot before transplanting, it would then be allowed as a mulch or 

as a compost feedstock under the current regulation. Certifiers who had not previously allowed the use 

of these paper pots still supported the extended allowance for use while the NOSB performed its 

review. 

There is more than one supplier of paper pots beyond the Nitten supplier noted in the petition.

Approval of this material will likely lead to other manufacturers competing for their share of this market. 

Synthetic paper pots can be made from natural fiber feedstock or from a mixture of natural fiber

feedstock and synthetic polymers. The pots with synthetic polymers are more typically used in the 

nursery trade where perennial plants may be in the pots for 9-12 months before transplanting into the 

field. Natural fiber pots are, at times, used in transplanting annual vegetable and floriculture seedlings, 

depending on the time frame between planting into the pot and planting out in the field and whether

the pots need extra strength for a “chain of pots” planting system. All of the paper pots contain some 

type of synthetic adhesive, but these same adhesives are also found in the recycled paper already 

allowed in organic agriculture.

Numerous commenters mentioned that all uses of paper as a production aid should be included when

the NOSB does its review for paper pots. Cloches or hot caps, seed tape, and cutworm prevention 

collars are other examples of production aids made from paper and typical paper adhesives that would 

decompose in the soil.

Specific Uses of the Substance:

Paper-chain pots are either single or in chains to allow for “mechanical” transplanting. The paper pots 

decompose in the soil and lessen transplant shock since the seedling root system is less disturbed, and 

the paper pots are part of a greenhouse-to-field growing system that requires considerably less labor 

NOSB October 2019 proposals and discussion documents Page 102 of 230
than hand transplanting. Use of paper pots may significantly reduce reliance on plastics. Growers can 

also use soil blocks, which are compressed soil without any container, to grow transplants.

Other paper crop production aids include: cloches, a temporary covering used to protect newly 

transplanted plants, seed tape on which individual seed is spaced correctly on a paper tape which 

lessens the need for thinning, and collars to prevent cutworm damage to plants at the soil line. There 

could be other uses of paper currently used as crop production aids, or there may be other uses 

developed over time. 

Approved Legal Uses of the Substance:

Newspaper and recycled paper are allowed under the organic regulations in these two references: 

Reference: 205.601(b) As herbicides, weed barriers, as applicable. (2) Mulches. (i) Newspapers or other 

recycled paper, without glossy or colored inks. 

Reference: 205.601(c) As compost feedstocks—Newspapers or other recycled paper, without glossy or 

colored inks. 

There have been two technical reports (TRs) on Newspaper and Other Recycled Paper in 2006 and 2017, 

which can be found here: https://www.ams.usda.gov/rules-regulations/organic/national-list/n. 

NOP guidance 5034-1 “Materials for Organic Crop Production” from December 2016 excludes virgin 

paper from the “newspaper or other recycled paper” allowance for mulch or compost feed stocks. The 

guidance states: “Includes newspaper and other recycled paper such as cardboard, without glossy or 

colored inks. Does not include paper that is not recycled (i.e., virgin paper).”

The July 2019 Technical Report of Paper Pots and Containers, which detailed the specific possible 

synthetic and natural fibers as well as synthetic adhesives found in paper pots currently commercially 

available, provided more clarity about manufacture and use of paper pots for the NOSB.

Manufacture:

Paper can be made from various plant sources including wood, trees, straw, hemp, bamboo, reeds, 

kenaf, sisal, jute, sugarcane bagasse, sunflower stalks, and as recycled sources of pulp. Cellulose sources 

are typically mechanically ground and then chemically “cooked” using an alkali or sulfite process. 

Newspaper and recycled papers can also have a variety of inks, although colored ink and glossy paper 

are not allowed as compost feedstocks or mulch. Paper used as a production aid could include the

typical adhesives found in newspaper and recycled paper. 

Subcommittee Discussion:

The crops subcommittee has reviewed the petition, technical reviews, and public comments and has 

developed a listing and annotation that we believe meets the needs of producers, while addressing 

environmental concerns that might be associated with some types of paper. When discussing the 

possible allowance for paper used as a production aid, the subcommittee also considered the fact that 

we currently have an allowance for paper used in organic production. It is the subcommittee’s view that 

there are few differences between the current paper allowance and the use of paper for plant pots and 

containers. 

NOSB October 2019 proposals and discussion documents Page 103 of 230
Category 1: Classification 

1. For CROP use: Is the substance _____ Non-synthetic or __x__ Synthetic? 

Is the substance formulated or manufactured by a process that chemically changes a substance 

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so, 

describe, using NOP 5033-1 as a guide.

The paper pulp production process and the adhesives used in maintaining structural integrity of 

the paper pots currently rely on synthetically manufactured ingredients. 

2. For CROPS: Reference to appropriate OFPA category:

Is the substance used in production, and does it contain an active synthetic ingredient in the 

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from 

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and 

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps 

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in 

production and contains synthetic inert ingredients that are not classified by the Administrator of 

the Environmental Protection Agency as inerts of toxicological concern?

 This material is a crop production aid, not a pesticide.

Category 2: Adverse Impacts 

1. What is the potential for the substance to have detrimental chemical interactions with other 

materials used in organic farming systems? [§6518(m)(1)]

Paper for plant pots/containers (as a crop production aid) is functionally identical to newspaper 

and recycled paper. This current listing of newspaper and recycled paper has been found to 

have no detrimental interactions with other materials in organic agriculture. Since virgin paper, 

with potentially different synthetic polymer makeup than recycled paper, would be allowed 

under this listing, a biodegradability standard in the annotation ensures that these paper 

products would not persist in the environment.

2. What is the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment? 

[§6518(m)(2)]

No toxicity or negative mode of action has been found in the breakdown of paper (cellulose) in 

the environment. No colored or glossy inks would be allowed for paper as a crop production 

aid, which would be aligned with the current annotation for paper as a compost feedstock 

and/or mulch. The 2019 TR found many of the adhesives and synthetic fibers biodegrade with 

no negative impacts. There were some that were not as environmentally neutral as others, but 

all are also present in paper under the current allowance. The subcommittee wants to ensure 

that the fibers used in paper products described by this petition will similarly biodegrade in the 

soil, especially given that virgin paper, with potentially different quantities of synthetic polymers 

than recycled paper, would be allowed. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

NOSB October 2019 proposals and discussion documents Page 104 of 230
There could be contaminants released into the environment during the manufacture of paper 

and environmental degradation caused by harvest of cellulose, but no more than newspaper or 

recycled paper. A difference between this paper and the previously approved newspaper and 

other recycled paper is that we are not restricting it to the use of only recycled paper products. 

The annotation will allow virgin stocks of cellulose to be used in the paper used as a production 

aid in organic agriculture. There are negative environmental impacts from harvesting trees to 

make paper such as deforestation, road building, soil erosion, and degraded water quality, but 

there are forestry best management practices that can help mitigate some these negative 

effects.

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)].

The 2019 TR did not find any evidence of harmful effects to human health.

5. Discuss any effects the substance may have on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms 

(including the salt index and solubility of the soil), crops and livestock. [§6518(m)(5)] 

Paper, as a material, is not harmful to the environment. The 2019 TR did not find any evidence 

of harmful effects to environmental health.

6. Are there any adverse impacts on biodiversity? (§205.200) 

No.

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)]

There are biodegradable pots made from composted cow manure, but these have never been 

petitioned for use in organic agriculture. We do not know if they could be approved or not. 

These pots contain 10% newspaper. There are also tools to help growers roll up newspaper into 

a pot. The paper chain pots offer greater efficiency for transplanting, although mechanical or 

hand transplanting operations can be used in both small- and large-scale operations with other 

types of containers. The future use of hemp fibers may also offer an alternative to synthetic 

polymers. 

2. In balancing the responses to the criteria above, is the substance compatible with a 

system of sustainable agriculture? [§6518(m)(7)]

The crops subcommittee has developed the annotation “Virgin or recycled paper, without 

colored or glossy inks; any synthetic fibers included must not exceed 15% of the paper and must 

be 100% biobased with content determined using ASTM D6866 (incorporated by reference; see 

205.3), and demonstrates at least 90% biodegradation absolute or relative to microcrystalline 

cellulose in less than two years, in soil, according to one of the following test methods: ISO 17556 

or ASTM D5988 (both incorporated by reference; see § 205.3)”. Continuing the prohibition on 

NOSB October 2019 proposals and discussion documents Page 105 of 230
colored and glossy inks prevents the incorporation into organic soil of the worst contaminants. 

Allowing the adhesives typically used in paper, makes this crop production aid equivalent to 

newspaper and recycled paper that is currently allowed. The allowance for virgin paper allows 

for special papers to be developed that meet the specific crop production needs for a variety of 

uses, and the amount of paper produced from virgin sources for these production aids would be 

very small compared to the amount of paper manufactured for all uses. Added fungicides, 

insecticides, or other synthetic materials not typically found in paper, would not be allowed 

under the current annotation. An unanswered question is whether it is practical and achievable 

to allow only natural fibers, using hemp or other fibers, to provide the strength needed in paper 

crop production aids. With the recommended annotation, paper as a crop production aid is 

compatible with a sustainable system of agriculture.

Discussion Questions:

1. Please comment on the following options under consideration by the subcommittee for listing at 

§ 205.601(o) as production aids: 

a. “Virgin or recycled paper, without colored or glossy inks,” or 

b. “Virgin or recycled paper, without colored or glossy inks; any synthetic polymer fibers

included must not exceed 15% of the paper and must be 100% biobased with content 

determined using ASTM D6866 (incorporated by reference; see 205.3), and demonstrates 

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

two years, in soil, according to one of the following test methods: ISO 17556 or ASTM 

D5988 (both incorporated by reference; see § 205.3)”

2. Synthetic polymer content— 

a. Should a maximum synthetic polymer content be stated explicitly? If so, what is the 

appropriate level? 

b. What is the amount (or range) of synthetic polymer content in products currently 

available? 

c. How would synthetic content be measured? How would a certifier or Material Review 

Organization verify content? For example, if a product included recycled paper as an 

ingredient, how would the synthetic polymer content be determined?

d. Is it possible to manufacture paper production aids that use only natural fiber sources and 

that meet the product specifications for their intended use?

3. Biodegradability— 

a. Should a biodegradability standard be included for these products? If so, is this the 

appropriate biodegradability standard?

b. Does maximum synthetic polymer content need to be stated if there is a biodegradability 

requirement? 

c. As the products biodegrade, what is the impact on the soil? Also, can fragments be 

consumed by wildlife or livestock before it is completely degraded?

4. Biobased content— 

a. Should a minimum biobased content standard be included for these products?

b. Is 100% biobased content achievable for these products? If not, what should be the 

minimum biobased content requirement? 

5. Is genetic engineering involved in the production of these products? 

6. Does the annotation need to specify that added fungicides, insecticides, or other synthetic 

materials not typically found in paper would not be allowed, or is that already understood?

NOSB October 2019 proposals and discussion documents Page 106 of 230
Subcommittee Vote:

 

Motion to accept the petitioned material discussion document on Paper (Plant Pots and Other Crop 

Production Aids)

Motion by: Harriet Behar

Seconded by: Steve Ela

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

Approved by Steve Ela, Crop Subcommittee Chair, to transmit to NOP August 14, 2019

NOSB October 2019 proposals and discussion documents Page 107 of 230
NOSB October 2019 proposals and discussion documents Page 108 of 230
National Organic Standards Board

Materials/GMO Subcommittee Proposal 

Excluded Methods Determinations October 2019

August 13, 2019

Introduction and background

At the November 18, 2016 in-person National Organic Standards Board (NOSB) meeting, the NOSB 

recommended that the National Organic Program (NOP) develop a formal guidance document for the 

determination and listing of excluded methods. The 2016 recommendation, entitled “Excluded Methods 

Terminology,” clarifies excluded method definitions and criteria in response to the increasing diversity in 

the types of genetic manipulations performed on seed, livestock, and other biologically-based resources

used in agriculture. Genetic engineering is a rapidly expanding field in science. To be responsive to this 

rapid expansion, the NOSB will continue to list new methods for review and will determine over time if the 

methods are or are not acceptable in organic agriculture. In addition to the 2016 recommendation, a 

discussion document provided a list of technologies needing further review to determine if they should be 

classified as excluded methods or not. 

At the Fall 2017 NOSB in-person meeting, the NOSB passed a recommendation to add three technologies 

as excluded methods to the NOP guidance document. In Fall 2018, the NOSB recommended one 

technology be added to the list of methods that are not to be excluded in organic production. In April 

2019, one more method was added to the list of methods to be excluded. The organic community, as well 

as the NOSB, has voiced a consistent stance that direct manipulation of genes through in vitro nucleic acid 

techniques should be considered an excluded method. This would include gene editing techniques such as 

CRISPR, which was determined to be an excluded method by the NOSB in November 2016. The NOSB will 

continue to review and determine various methods and technologies to provide clarity to the organic 

community on which methods could be allowed and which ones are excluded.

Goals of this proposal/document

This proposal addresses two more items on the “To Be Determined” list found in the November 2016

discussion document. At the April 2019 NOSB meeting, a discussion document was presented for public 

comment for the two items covered in this proposal: induced mutagenesis and embryo transfer in 

livestock. 

Public comment at numerous NOSB meetings over the years continues to stress the view that technologies

used to manipulate the genetic code in a manner that is outside traditional plant and animal breeding 

should remain prohibited in organic production. Among organic stakeholders, there is a strong belief that 

genetic engineering is a threat to the integrity of the organic label. Both organic producers and consumers 

reject the inclusion of genetic engineering in organic production. This document represents the continuing 

work of the NOSB to clarify which methods in the expanding field of genetic engineering can or cannot be used 

under the USDA organic seal. 

The Materials Subcommittee recognizes the topic of genetic engineering and evaluation of excluded 

methods will remain on our work agenda to determine if new technologies do or do not meet our 

current definitions. We may also need to incorporate additional criteria to evaluate new and unique 

technologies. 

We are aware that specific laboratory tests are not currently available to detect the use of several

NOSB October 2019 proposals and discussion documents Page 109 of 230
new excluded genetic modification technologies in organisms. However, we still believe that the 

technology should be listed as an excluded method, when appropriate, and anticipate tests or other 

methods will be developed over time to detect the presence of these technologies. The Materials 

Subcommittee may put forward another discussion document in the future to aid the NOP in 

determining how to enforce this prohibition when there is no means to detect an excluded method 

that may have been used in production. 

Definitions and Criteria

Under the National Organic Program organic regulations, methods that employ genetic engineering 

techniques are excluded from use in organic production. The current regulation defines an excluded 

method as:

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). Such methods do not 

include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or 

tissue culture. 

Below are the criteria listed in the 2016, 2017, 2018 and 2019 NOSB recommendations to determine if 

methods should be excluded. The table includes the NOSB vote in April 2019, to add transposons

developed via use of in vitro nucleic acid techniques as an excluded method.

1. The genome is respected as an indivisible entity, and technical/physical insertion, deletions, or

rearrangements in the genome is refrained from (e.g. through transmission of isolated DNA, RNA, or

proteins). In vitro nucleic acid techniques are considered to be an invasion into the plant genome.

2. The ability of a variety to reproduce in a species-specific manner has to be maintained, and genetic use

restriction technologies are refrained from (e.g. Terminator technology).

3. Novel proteins and other molecules produced from modern biotechnology must be prevented from

being introduced into the agro-ecosystem and into the organic food supply.

4. The exchange of genetic resources is encouraged. In order to ensure farmers have a legal avenue to

save seed and plant breeders have access to germplasm for research and developing new varieties,

the application of restrictive intellectual property protection (e.g., utility patents and licensing

agreements that restrict such uses to living organisms, their metabolites, gene sequences, or breeding

processes) are refrained from.

The NOSB has voted and determined these to be excluded methods: 

NOSB October 2019 proposals and discussion documents Page 110 of 230
Method and

synonyms

Types Excluded

Methods

Criteria

Applied

Notes

Targeted genetic

modification (TagMo) 

syn. Synthetic gene 

technologies syn. 

Genome 

engineering 

syn. Gene 

editing syn. 

Gene

targeting 

Sequence-specific

 nucleases (SSNs) 

Meganucleases Zinc finger nuclease 

(ZFN) 

Mutagenesis via

 Oligonucleotides

CRISPR-Cas system (Clustered regularly 

interspaced short palindromic repeats)

and associated protein genes 

TALENs (Transcription activator-like 

effector nucleases) 

Oligonucleotide directed mutagenesis 

(ODM) Rapid Trait Development System

YES 1, 3, 4 Most of these new

techniques are not 

regulated by USDA and 

are currently difficult to 

determine through 

testing. 

Gene Silencing RNA-dependent DNA

methylation (RdDM) Silencing via 

RNAi pathway RNAi pesticides

YES 1, 2, 4

Accelerated plant

breeding techniques

Reverse Breeding

Genome Elimination 

FasTrack

Fast flowering 

YES 1, 2, 4 These may pose an

enforcement 

problem for organics

because they are not 

detectable in tests.

Synthetic Biology Creating new DNA

sequences 

Synthetic chromosomes Engineered 

biological functions and systems

YES 1, 3, 4

Cloned animals and

offspring 

Somatic nuclear transfer YES 1, 3

Plastid

transformation

YES 1, 3, 4

Cisgenesis The gene modification of a recipient 

plant with a natural gene from a 

crossable-sexually compatible-plant. 

The introduced gene includes its introns 

and is flanked by its native promoter 

and terminator in the normal-sense 

orientation.

YES 1, 3, 4 Even though the genetic

manipulation may be within 

the same species; this 

method of gene insertion 

can create characteristics

that are not possible within 

that individual with natural 

processes and can have 

unintended consequences.

NOSB October 2019 proposals and discussion documents Page 111 of 230
Intragenesis The full or partial coding of DNA 

sequences of genes originating from 

the sexually compatible gene pool of 

the recipient plant and arranged in 

sense or antisense orientation. In 

addition, the promoter, spacer, and 

terminator may originate from a 

sexually compatible gene pool of the 

recipient plant.

YES 1, 3, 4 Even though the genetic

manipulation may be within 

the same species, this 

method of gene 

rearrangement can create

characteristics that are not 

possible within that 

individual with natural 

processes and can have 

unintended consequences. 

Agro-infiltration YES 1, 3, 4 In vitro nucleic acids are

introduced 

to plant leaves to be 

infiltrated into them. The 

resulting plants could not 

have been achieved through 

natural processes and are a 

manipulation of the genetic 

code within the nucleus of 

the organism. 

TransposonsDeveloped via use of in 

vitro nucleic acid 

techniques

YES 1,3,4 Does not include 

transposons developed 

through environmental 

stress such as heat, 

drought or cold.

The following genetic engineering methods were found by the NOSB NOT to be excluded methods: 

Method and

synonyms

Types Excluded

Methods

Criteria

Applied

Notes

Marker Assisted

Selection 

NO

Transduction NO

Embryo rescue in plants NO IFOAM’s 2018 position 

paper on Techniques in 

Organic Systems considers 

this technique compatible 

with organic systems.

 

NOSB October 2019 proposals and discussion documents Page 112 of 230
The following methods will continue to be researched in future NOSB proposals: 

Terminology

Method and synonyms Types Excluded

Methods

Criteria 

Used

Notes

Protoplast Fusion TBD There are many ways to

achieve 

protoplast fusion, and 

until the criteria about 

cell wall integrity are

di d d Cell Fusion within Plant Family TBD Subject of an NOP memo in 

2013. The Crops 

Subcommittee will continue 

to explore the issue of 

 TILLING Eco-TILLING TBD Stands for “Targeted Induced

Local Lesions In Genomes.” 

It is a type of mutagenesis 

bi d ith Doubled Haploid Technology 

(DHT)

TBD There are several ways to

make double haploids, and 

some do not involve genetic 

engineering while some do. 

It is difficult or impossible to

 Induced Mutagenesis TBD Induced mutagenesis 

developed through exposure 

to UV light, chemicals,

irradiation or other stress 

 

 Transposons TBD Produced from chemicals, 

ultraviolet radiation, or 

other synthetic activities 

 

Discussion and Public Comment 

Induced Mutagenesis

The April 2019 NOSB discussion document covered a variety of methods that could result in 

induced mutagenesis. Public comment overwhelmingly stated that environmental or other 

stresses that induce mutagenesis need more deliberate discussion. Impact on current plant 

breeding methods needs to be carefully considered, as well as consistency with what is allowed 

and not allowed, in organic agriculture. Having clear definitions and accessibility in determining 

which items may or may not have been developed through stress induced mutagenesis is needed 

to provide seed breeders and companies, certifiers, and producers the information they need to 

meet any possible restrictions discussed in the future. 

However, it was clear that induced mutagenesis developed through in vitro nucleic acid techniques 

meets the criteria to be determined as an excluded method. Information is accessible in the 

marketplace to determine if the induced mutagenesis was produced through this method. This 

proposal adds this type of in vitro nucleic acid technique induced mutagenesis to the excluded 

NOSB October 2019 proposals and discussion documents Page 113 of 230
method table and keeps induced mutagenesis developed through exposure to UV light, chemicals, 

irradiation, or other stress-causing activities on the “To Be Determined” list for future discussion 

and review.

Embryo transfer, or embryo rescue, in animals

This technique used in animal breeding, involves inducing superovulation of the donor animal with 

gonadotropins (glycoprotein polypeptide hormones), artificial insemination of the donor animal, 

recovery of embryos from the donor, isolation and storage of embryos, and transfer of embryos 

into a recipient animal (either with or without hormones to synchronize estrus), which results in a 

pregnancy and hopefully a birth of a live animal at maturity. Many organic certifiers stated they 

currently allow this method of embryo transfer in organic agriculture. In nonorganic agriculture, 

the recipient animal may also be given hormones to improve the success of the embryo transfer, 

but no organic certifiers allowed the use of these hormones in the recipient animal to synchronize 

estrus. 

In response to the question of whether this technique might narrow the genetic pool in livestock, 

commenters were sympathetic to this concern but felt that organic farmers would be careful in 

choosing embryos that would result in genetic diversity in their livestock. There were no concerns 

expressed for the health of the nonorganic donor animal after repeated use of hormones to 

produce multiple embryos, nor possible future health issues in the animals grown from those 

embryos. While embryo transfer was not found to be a necessary method by the public, numerous 

commenters stated it is a useful tool that should be allowed.

Future Work on this Topic

The NOSB encourages the public to continue the dialogue on the various methods that cause induced 

mutagenesis and provide information on which methods, chemical, UV light, irradiation, or others should or 

should not be considered excluded for organic production.

Subcommittee Proposal

The NOSB recommends the NOP add the following to the table of excluded methods, in the NOP excluded 

methods guidance: 

1. Induced mutagenesis - Developed via use of in vitro nucleic acid techniques.

The NOSB recommends the NOP add the following to the table of “not excluded” methods, in the NOP 

excluded methods guidance: 

2. Embryo transfer, or embryo rescue, in animals. Use of hormones not allowed in recipient animals.

Subcommittee Vote:

Motion to accept the proposal on excluded methods determinations October 2019 

Motion by: Harriet Behar

Second: Dan Seitz

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

Approved by Emily Oakley, Materials Subcommittee Chair, to transmit to NOSB August 13, 2019

NOSB October 2019 proposals and discussion documents Page 114 of 230
National Organic Standards Board

Materials Subcommittee Proposal

Genetic Integrity Transparency of Seed Grown on Organic Land - Instructions to Certifiers

August 13, 2019

I INTRODUCTION 

The USDA National Organic Program (NOP) regulations do not allow the use of materials developed using 

“excluded methods” in certified organic production. The USDA defines “excluded methods” as , “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...” (7 CFR 205.2). These organisms include, but 

are not limited to, seed, bacteria, insects, animals and vaccines. According to the most recent National 

Agricultural Statistics Survey (NASS), at least 94% of soybeans, 92% of corn, 94% of cotton, 75% of Hawaiian 

papaya, 98% of sugar beets, and 90% of canola are genetically engineered. This proposal will address seed 

planted on organic land that may have a Genetically Engineered (GE) equivalent. 

II BACKGROUND

The National Organic Standards Board (NOSB), in separate recommendations in 2016, 2017, 2018, and 

2019, defined terms used when describing gene altering technologies and the subset of those methods 

deemed to be excluded methods. This list is continually under review, with new methods being added 

periodically. The list of those excluded methods are as follows: 

• Sequence-specific nucleases (SSNs)

• Meganucleases Zinc finger nuclease (ZFN)

• Mutagenesis via Oligonucleotides

• CRISPR-Cas system (Clustered regularly interspaced short palindromic repeats) and associated

protein genes

• TALENs (Transcription activator-like effector nucleases)

• Oligonucleotide directed mutagenesis (ODM) Rapid Trait Development System

• RNA-dependent DNA methylation (RdDM)

• Silencing via RNAi pathway RNAi pesticides

• Reverse breeding

• Genome elimination

• FasTrack

• Fast flowering

• Creating new DNA sequences

• Synthetic chromosomes

• Engineered biological functions and systems

• Somatic nuclear transfer

• Plastid transformation

• Cisgenesis

• Intragenesis

• Agro-infiltration

• Transposons-Developed via use of in vitro nucleic acid techniques

Currently in the U.S., testing is not required to verify if seeds planted on organically certified farms were 

NOSB October 2019 proposals and discussion documents Page 115 of 230
produced using an excluded method. Organic farmers plant both organic and non-organic seed (when the 

organic seed is not commercially available in the form, variety, or quantity required). Some, but not all, 

certification agencies perform genetically engineered (GE) testing on a farmer client’s harvested crop. 

Proposed here is an additional step; certifiers should recommend that their farmers request information on 

any GE testing performed on seed they may purchase.

To meet the current certification standard, farmers are required to provide documentation that the seed they 

plant was not produced using excluded methods. This standard is met in one of two ways. 1) Certified organic 

seed breeding companies must verify excluded methods were not used in the production of certified organic 

seed. 2) For non-organic seed, a non-GE affidavit is required if the crop has a genetically engineered 

equivalent in the marketplace. Affidavits typically state “to the best of the seed supplier’s knowledge, the 

seed was not produced using excluded methods”; however, the affidavit does not address the issue of 

possible contamination of the seed lot with seed produced using excluded methods. The intentional use of 

seed produced by an excluded method is prohibited. Non-GE affidavits have been accepted as proof by 

organic certifiers that the seed is acceptable in organic systems.

In a previous discussion document the Material’s Subcommittee discussed a proposed requirement that all field 

corn seed planted on organic land be accompanied by a statement detailing any presence of GE within specific 

percentages, such as .1%, .9% etc. levels. While many farmers, consumers, advocates, and certifiers liked the 

transparency this would have provided, there was significant concern from all groups, especially seed breeders, 

that there could be unintended negative consequences from this requirement. These potential negative 

consequences included added cost of disseminating this information, loss of germplasm and seed varieties to 

organic producers if there is significant presence of GE in the seed, loss of genetic diversity available to organic 

farmers, and more. This proposal recommends the NOP provide an instruction to certifiers informing 

producersthey can request the results of any testing for presence of genetic engineering in the seeds they 

purchase. 

In the development of this proposal, NOSB members and the public, specifically the Organic Seed Alliance, 

reached out to numerous suppliers of field corn seed that typically serve the organic market. This includes both 

organic and nonorganic seed growers. The vast majority of seed suppliers reported that they already test their 

field corn seed for detectable levels of genetic engineering, and, when asked, are willing to provide this testing

information to those who buy their seed.. Most farmers are not aware that this testing is being done, and 

consequently, most do not currently request this information. 

If farmers don’t know what they are starting with, it puts them in a compromised position when they sell their 

crop; after all, they are committed to producing GE-free grains, fruits, and vegetables. On the other hand, the 

organic marketplace, or the “back end” of the food system, has developed a fairly robust testing protocol for 

organic foods intended for human consumption as well as livestock feeds. Various tolerance levels of genetic 

contamination must be met in order to sell into specific markets. Knowing the purity of the seed farmers plant 

on the “front end” is critically important for several reasons. The level of contamination at the beginning of the 

season will not decline and can only worsen by cross-pollination and post-harvest seed handling. To meet 

organic market demand and to provide farmers with what they need to make informed decisions when 

choosing seeds, transparency of GE contamination levels and the knowledge of the adventitious presence of 

genetic engineering in their seed has become a necessity.

The NOSB put forth discussion documents and proposals addressing the issue of clarity around genetic 

purity of the seed supply in 2013, 2014, 2015, 2016, 2017, and 2018. The strong response from the public 

in the form of many comments clearly demonstrates the importance of this issue for organic farmers,

NOSB October 2019 proposals and discussion documents Page 116 of 230
processors, and consumers. 

III RELEVANT AREAS OF THE STATUTE, RULE and RELATED DOCUMENTS

Detection and Testing Requirements: Under the NOP residue testing requirements, 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 as “100 percent organic,” 

“organic,” or “made with organic (specified ingredients or food group(s)).”

(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. 

NOP Policy: The NOP issued a Policy Memo on April 15, 2011 (Policy Memo 11-13) on genetically 

engineered organisms. The memo clearly states that the use of genetically engineered organisms is 

prohibited and goes on to address questions that have been raised concerning the use of these

organisms and how to minimize their presence in organic production and handling. The memo 

emphasizes that organic certification is a process-based standard, explaining the presence of detectable 

GMO residue alone does not necessarily constitute a violation of the regulation. 

IV RESPONSE TO PUBLIC COMMENT

Public comment from most seed suppliers and producers, did not favor tolerance levels due to concerns 

that this approach would narrow the availability of needed crop traits and the overall crop choice. Concern 

was also raised that strict tolerance levels could result in the unintended consequences such as damage to

the growth and integrity of organic agriculture, as well as negative impacts to organic growers and seed

breeders. This proposal does not set tolerance levels that could prohibit the planting of seed that exceeds 

any specific tolerance. Instead, this proposal seeks to encourage certifiers and farmers to seek out the 

currently available information before planting seed that has a GE equivalent on organic land. 

There are no current restrictions that would prevent a farmer from taking a sample of hybrid corn seed (a 

non-GMO variety) or other seeds they purchase and having them tested for the presence of GE. There are 

agreements that seed breeders might encounter when purchasing the foundation seed for building their 

own hybrid varieties that could restrict them from testing that seed for the presence of GE. However, this 

proposal only requires testing of the seed that would be planted by an organic producer who has no legal 

impediments to this testing. Farmers would not be required to do GE testing of their seed, but if their seed 

supplier does not provide GE contamination test results for their seed, this option is open to the farmer.

In addition, it is a good practice for farmers to retain seed samples of seed they plant on organic land, and 

certifiers can suggest this to farmers as another step in finding the source of GE contamination in case their 

crop is rejected by a buyer at harvest time.

NOSB October 2019 proposals and discussion documents Page 117 of 230
The previous discussion documents on the issue of genetic integrity transparency of seed, focused only on

field corn seed. This proposal addresses all seed or planting stock that has a GE equivalent in the 

marketplace. There is no specific requirement, other than for certifiers to instruct their clients about the 

option to request GE contamination test results from their seed and planting stock providers. 

The NOSB continues to request that the NOP fund a task force that would collect information on the genetic 

integrity of seed planted on organic land so the organic community - from farmers to consumers - would 

have statistical information detailing GE contamination issues. This task force would be empowered to 

collect data for multiple years, since growing conditions and crop production issues change from year to 

year, and in order to collect useful information, numerous years and regions must be tracked. We know 

there are issues with some crops in some regions, but there has not been a comprehensive review of data to 

provide a clear picture of the problems. Without this information, the organic community cannot develop 

solutions.

V Proposal

The NOSB recommends the NOP provide an “Instruction to Certifiers”. 

The purpose of this instruction is to have certifiers inform their producers that GE contamination of seed or 

planting stock is being tested regularly by those suppliers who are at risk for GE contamination of their 

products. Producers are encouraged to discuss GE contamination with suppliers willing to share the results 

of the GE testing they are currently doing but typically do not disseminate, unless requested by the buyer of 

the product.

Certifiers should be proactive in encouraging their farmers who grow organic crops according to the USDA 

organic regulations, and who could be at risk of having crops rejected by their buyers due to presence of GE 

contamination, to obtain information from their seed or planting stock suppliers about any GE 

contamination found. Certifiers can request this GE contamination information from their organic 

producers, and they may choose to maintain that information in the client’s organic certification records. 

Farmers can then make informed decisions about which seed or planting stock to use based upon the 

requirements of their buyers and their production situations that may or may not result in GE 

contamination in their fields. Obtaining this GE contamination information before planting can be beneficial 

in lessening the risk of significant economic losses due to GE contamination when that crop is sold. The 

discussion between growers and seed suppliers may also demonstrate there is a demand for seed with low 

GE contamination levels.

1. In order to aid producers in their goal of low-to-no detection of GE contamination of their organic crops 

(seed and planting stock) that have GE equivalents in the marketplace, certifiers should provide the 

following information to their organic farmers:

A. Producers who are growing crops from seed or planting stock that could be subject to Genetic 

Engineering contamination of that seed or planting stock, can contact their suppliers to obtain GE 

contamination test results.

B. The vast majority of seed and planting stock suppliers whose crops have GE equivalent varieties that 

could cause contamination are already doing GE contamination testing and are supplying 

information, at the request of the buyer of their seed or planting stock, of any GE contamination 

and the levels present.

C. Certifiers may choose to obtain this information at the organic inspection. If presence of GE 

NOSB October 2019 proposals and discussion documents Page 118 of 230
contamination is found on the finished crop by the certifier in their testing program or by a buyer of 

the finished crop, this seed GE contamination information will be useful in determining the cause of 

the GE contamination.

D. Certifiers can inform farmers who wish to test seed they grew or test seed or planting stock they 

purchased, that they are legally allowed to test for GE contamination. A wide variety of laboratories 

around the U.S. and the world supply this testing service. This information could be provided to the 

organic certifier as well.

Subcommittee vote: 

Motion to accept the “Genetic Integrity Transparency of Seed Grown on Organic Land Instructions to 

Certifiers” Proposal

Motion by: Harriet Behar

Seconded by: Dave Mortensen

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

Approved by Emily Oakley, Subcommittee Chair to transmit to NOSB, August 13, 2019

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NOSB October 2019 proposals and discussion documents Page 120 of 230
USDA National Organic Standards Board Research Priorities, 2019

Executive Summary

Overall: The National Organic Standards Board (NOSB) presents an annual list of research priorities for 

organic food and agriculture. The NOSB requests that integrated research be undertaken with 

consideration of the whole farm system, recognizing the interplay of agroecology, the surrounding 

environment, and both native and farmed species of plants and animals.

Livestock

1. Evaluation of methionine in the context of a system approach in organic poultry production.

2. Prevention and management of parasites, examining breeds, geographical differences,

alternative treatments, and pasture species.

3. Organic livestock breeding for animals adapted to outdoor life and living vegetation.

Crops

1. Examination of decomposition rates, the effects of residues on soil biology, and the factors that

affect the breakdown of biodegradable biobased mulch film.

2. Conduct whole farm ecosystem service assessments to determine the economic, social, and

environmental impact of farming systems choices.

3. Organic no-till practices for diverse climates, crops, and soil types.

4. Develop cover cropping practices that come closer to meeting the annual fertility demands of

commonly grown organic crops.

5. Development of systems-based plant disease management strategies are needed to address

existing and emerging plant disease threats.

6. The demand for organic nursery stock far exceeds the supply. Research is needed to identify the

barriers to expanding this market, then develop and assess organic methods for meeting the

growing demand for organically grown nursery stock.

7. Strategies for the prevention, management, and control of invasive insects.

8. Factors impacting organic crop nutrition, and organic/conventional nutrition comparisons.

9. Side-by-side trials of organic synthetic materials, natural materials, and cultural methods, with a

request for collaboration with the IR4 project.

Food Handling and Processing

1. Comparison of alternatives to chlorine materials in processing: impact mitigation, best

management practices, and potential for chlorine absorption by produce.

2. Production of celery for celery powder yielding nitrates sufficient for cured meat applications,

and investigation of agriculturally derived alternatives.

3. Suitable alternatives to BPA (Bisphenol-A) for linings of cans used for various products.

Coexistence with GE and Organic Crops 

1. Outcome of genetically engineered (GMO/GE) material in organic compost.

2. Evaluation of public germplasm collections of at-risk crops for the presence of GE traits, and

ways to mitigate small amounts of unwanted genetic material in breeding lines.

3. Develop then implement methods of assessing the genetic integrity of crops at risk in order to

quantify the current state of the organic and conventionally produced non-GMO seed.

NOSB October 2019 proposals and discussion documents Page 121 of 230
4. Techniques for preventing adventitious presence of GE material in organic crops, and evaluation

of the effectiveness of current prevention strategies.

5. Testing for fraud by developing and implementing new technologies and practices.

General

1. Examination of the factors influencing access to organically produced foods.

2. Production and yield barriers to transitioning to organic production to help growers successfully

complete the transition.

NOSB October 2019 proposals and discussion documents Page 122 of 230
National Organic Standards Board 

Materials Subcommittee Proposal

2019 Research Priorities

August 13, 2019

INTRODUCTION

The National Organic Standards Board (NOSB) presents an annual list of research priorities for organic 

food and agriculture. The NOSB’s Livestock, Crops, Handling, and Materials/GMO Subcommittees 

propose the priorities at the fall board meeting and reflect both written and oral public comments 

received by the Board. The topics listed below are the 2019 priorities. 

BACKGROUND

The list of priorities is revisited each year by the NOSB. The list is made meaningful by input through the 

written and oral public comments shared with the Board, through the expertise of the Board itself and 

through interactions throughout the year with those engaged in some dimension of the organic farm to 

fork continuum. When the NOSB has determined that a priority area has been sufficiently addressed, it 

is removed from the list of priorities. Priorities are also edited each year to more accurately reflect the 

existing need for new knowledge. Four new research priorities were added in 2019.

The NOSB encourages collaboration with and between laboratories, federal agencies, universities, 

foundations and organizations, business interests, organic farmers, and the entire organic community to 

seek solutions to pressing issues in organic agriculture and processing/handling.

PROPOSAL: 2019 RESEARCH PRIORITIES

The NOSB encourages integrated, whole farm research into the following areas:

Livestock

1. Evaluation of Methionine in the Context of a System Approach in Organic Poultry Production 

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 heightened 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 to help find approaches for making them more commercially available. 

Continued research on the use of synthetic methionine in the context of a systems approach (nutrition, 

genetic selection, management practices, etc.) is consistent with the NOSB unanimous resolution passed 

at the La Jolla, California, Spring 2015 board meeting. A systems approach that includes industry and 

independent research by USDA/ARS, on farms, and by agricultural land grant universities is needed for 

(1) evaluation of the merits of natural alternative sources of methionine such as herbal methionine, high 

methionine corn, and corn gluten meal in organic poultry production systems; (2) evaluation of poultry 

breeds selection that could be adaptive to existing organic production systems – inclusive of breeds 

being able to adequately perform on less methionine; and (3) assessment of management practices for 

improving existing organic poultry welfare under different conditions. Research findings and 

collaborations under various climates, housing types, geographical regions, and countries should be 

noted and researched, where applicable. Certainly, the fruition of these types of research topics could 

take years to achieve the expressed NOSB resolution; however, an aggressive and/or heightened 

NOSB October 2019 proposals and discussion documents Page 123 of 230
research focus could lead to findings that can positively impact the organic poultry industry and the 

organic brand. The continued focus on methionine with a systems approach is imperative and 

necessary. 

The key research areas should include the efficacy and viability of alternatives such as: herbal 

methionine, corn gluten meal, potato meal, fishmeal, animal by-products, and other non-plant 

materials. Additional research on the more promising alternatives to bring them into commercial 

production is also encouraged. Additionally, management practices impacting the flock’s demand for 

methionine should be included, such as flock management practices, access to pasture, and pasture

management.

2. Prevention and Management of Parasites 

Livestock production places large numbers of cattle, sheep, goats, poultry etc. into relatively close 

contact with each other on fields and in barns. Organic production does not allow antibiotic use and 

requires that livestock be raised in a manner which approximates the animal’s natural behavior. The 

organic farmer can use synthetic parasiticides in an emergency but not prophylactically. Synthetic 

parasiticides have many limitations. Even if prophylactic treatment with parasiticides were possible, it is 

clear that parasite immunity to chemical control will inevitably occur. Thus, prevention of parasites is 

critical. 

The research question on prevention and management of parasites must be systems based. What farm 

systems, animal breeds, herd or flock management systems have shown the best results with parasite 

control over the last twenty years? What regional differences are there in the US in parasite 

prevention? Are there specific herbal, biodynamic, or other alternative treatments that have been 

proven to work over time? What are the parasite-resistant breeds? Are there plant species in pastures 

and scrublands that could be incorporated into the annual grazing system to reduce the spread of 

parasites or to provide prevention through the flora, fauna, and minerals ingested? Which pasture 

management systems appear to be best for parasite prevention in various parts of the country? Are 

pasture mixes being developed that include plants known to prevent parasites in various breeds? 

 

3. Organic Livestock Breeding

Organic rules require livestock products originate from animals that are not confined and are adapted to 

outdoor living as well as obtaining feed from living vegetation. A current FAO report states that globally

one third of pigs, half of all egg layers, two thirds of milk animals, and three quarters of meat chickens 

are produced with breeds more suited to confinement or “industrial” production systems than a typical 

organic farm or ranch. Similar to plant breeding, the organic community sees a great need for 

regionally-adapted and publicly available livestock breeds that can thrive in organic systems.

Heritage, native regional breeds, and breeds used in the EU and other areas of the world that are

typically more adapted to organic systems are still present but in small numbers. Increased research on 

the breeding, production needs, and improvement of these breeds is needed. Traits for good 

conversion rates from grazing to milk or meat, meeting consumer expectations for quality, as well as 

having the constitution and temperament to thrive outdoors would increase both the profitability and 

resiliency of organic livestock operations. Animal breeds that may have immunity to a variety of 

diseases and parasites would be useful traits to research and incorporate in a breeding program. 

NOSB October 2019 proposals and discussion documents Page 124 of 230
Crops

1. Biodegradable Bio-based Mulch Film 

This type of mulch film was recently approved by the NOSB but did not include a specific percentage of 

bio-based components it must contain. In 2015, NOP issued a Policy Memo1 that states that certifiers 

and material organizations should review biodegradable bio-based mulch film products to verify that all 

of the polymer feedstocks are bio-based. This requirement makes bio-based mulches unavailable to 

organic producers due to the petroleum-based polymers in these mulch films. In order to provide a 

recommendation to the NOP addressing the presence of petroleum-based polymers in these mulches, 

the answers to the following questions would be useful to develop more clarity on mulch films and 

possibly develop an additional annotation to address any concerns:

• How rapidly do these mulches fully decompose, to what extent does cropping system, soil type, 

and climate mediate decomposition rates, and does the percentage of the polymers in the 

mulch film affect the decomposition rate? Are there metabolites of these mulches that do not 

fully decompose?

• Do breakdown byproducts influence the community ecology and ecosystem function of soils, 

plants, and the livestock that graze on crops grown in these soils? 

• As fragments degrade, do they pose a problem to terrestrial and aquatic wildlife?

• Do the residues of these films accumulate after repeated use? 

• Are the testing protocols in place to insure decomposition standards? 

2. Ecosystem service provisioning and biodiversity of organic systems (New in 2019)

How do organic systems impact ecosystem service provisioning, both on-farm and through the materials 

and inputs sourced and used for production? For example, what impact does ocean harvesting of 

seaweed for use as a fertilizer have on ecosystem health and service provisioning? Can farm-mapping 

be performed to quantify the impact of the location of a farm (in a broader landscape) and the 

arrangement of fields and non-crop habitat to enhance biodiversity and ecosystem service provisioning?

3. Organic No-Till

Organic no-till, using a terminated cover crop for in-place mulching, can increase soil health and provide 

for increased biodiversity. Organic no-till preserves and builds soil organic matter, conserves soil 

moisture, reduces soil erosion, and requires less fuel and labor than standard organic row crop farming. 

There can also be some challenges from organic no-till using a cover crop, such as occasional insect 

infestation associated with the cover crop. 

Even though this killed-in-place mulch practice has been used for more than a decade, widespread 

adoption has not occurred. Increased research is needed to develop organic no-till systems that function 

for a wide variety of crops in diverse climates and soil types. Annual crops such as commodity row crops 

and specialty crops, as well as perennial crops such as tree fruits, berries, and grapes would all benefit 

from these organic no-till practices. Research areas that could be covered include:

• Development of plant varieties that have specific characteristics, such as early ripening, to aid in 

the effectiveness and practicality of organic no-till.

• What combination of mulch crops and cultural systems sustain crop yields, provide soil health 

benefits, and suppress weeds? 

• How does organic no-till influence pest, weed, and disease management?

• What specific insect problems can be caused or exacerbated by cover crops used as mulches, 

and how can those problems best be managed?

• In perennial cropping systems, such as fruits, what are the benefits or drawbacks of using this 

1 Policy Memo 15-1

NOSB October 2019 proposals and discussion documents Page 125 of 230
mulching system on weed, pest, and disease management, as well as soil fertility?

• What are the biodiversity benefits to these living and/or killed mulches, and how does this 

contribute to pest, weed, and disease management?

• Does this system affect the nutrient balance of the soil and subsequent fertilization practices, 

including use of outside inputs?

• Based on the improved soil health, when there is less soil disturbance and more plant 

decomposition resulting in higher organic matter, how does this system affect soil microbial life 

and nutrient availability, and does this then result in crops that are less susceptible to disease 

and pests?

Finally, organic farmers use whole-farm planning when deciding what will be done in each of their fields. 

Research that assesses the ecosystem benefits of reducing tillage in patches (field-level) across a farm is 

also needed. For example, the relative benefits of reducing tillage are greater in areas prone to surface 

water runoff. Research is needed to “inform” where reduced tillage practices are likely to have their 

greatest impact. 

4. Managing Cover Crops for On-Farm Fertility (New in 2019) 

Growing cover crops and green manures is a foundational practice on many organic farms. In addition 

to conserving soil, increasing water holding capacity, and providing weed suppression, cover crops can 

supply important plant nutrients and increase soil organic matter. As farmers seek to grow their own 

fertility, more research is needed on the efficacy of relying exclusively or almost exclusively on cover 

crops to meet production needs. At present, there is inadequate data on the various nutrient benefits 

of different cover crop mixes and how those benefits vary according to species mix, mowing practices, 

tillage regimes, and subsequent planting time of the cash crops. This topic asks researchers to examine 

farm fertility needs using cover crops as the sole or primary form of nutrient delivery. 

5. Disease Management

Disease management in organic fruit and vegetable production relies on a systems approach to succeed, 

but even with current systems plans in place, growers frequently struggle to manage commonly 

occurring blights and citrus greening. The NOSB underscores the need for systems research that 

addresses solutions to these and related diseases that are workable for farmers, that reduces adverse 

health effects on farmers and fieldworkers, and that also limits adverse effects on the soil and water in 

which the crops grow. To this end, we call for systems research that identifies disease resistant material 

while at the same time identifying biological controls that limit the use of copper-based compounds 

where possible. 

Specifically, targeted research is needed to identify management practices and less toxic alternative 

materials for a wide range of crops. More research is needed on many of the crop/disease 

combinations, including: 

• Comprehensive, systems-based approaches for managing individual crops in a way that 

decreases the need for copper-based materials, including researching crop rotations, sanitation 

practices, plant spacing, and other factors that influence disease. 

• Breeding plants that are resistant to the diseases that copper controls. 

• Developing alternative formulations of materials containing copper so that the amount of 

elemental copper is reduced. 

• Developing biological agents that work on the same diseases that copper is now used on. 

• Evaluating plant nutritional strategies to mitigate the impacts of plant diseases. 

• Particular research on scum and algae control in rice and whether sodium carbonate 

peroxyhydrate or other materials are suitable alternatives in an aquatic environment. 

NOSB October 2019 proposals and discussion documents Page 126 of 230
6. Identify Barriers and Develop Protocols for Organic Nursery Stock Production (new in 2019)

The demand for organic nursery stock far exceeds the supply. Research is needed to identify the 

barriers to expanding this market, then develop and assess organic methods for meeting the growing 

demand for organically grown nursery stock. That work could include but is not limited to assessing 

phytosanitary rules for shipping plants and quantifying the production and demand for organic 

rootstock. Finally, research centered on development of practical organic methods for the nursery 

industry to implement is needed. 

7. Management and Control of Invasive Insects

There is a large pool of research on the control of insects and diseases using organic methods. Many 

controls use a systems approach and are quite effective. The introduction of new invasive species into 

cropping systems threatens these systems approaches, and in several cases the organic control options 

are very limited or nonexistent. For example, spotted wing drosophila is a relatively recent invasive 

insect that infests soft fruits, such as berries, and many other fruits as well. Infestation renders fruit 

unusable since insect larvae feed inside the fruit and may reach critical levels before fruit is 

harvested. This insect is particularly problematic in that it has the ability to oviposit in green fruit, and it 

has multiple generations throughout the summer, creating an extensive control period. There is only 

one control material available, and it is in danger of overuse. The control period may also extend so 

long that maximum label rates are used before the season ends. A second invasive insect is brown 

marmorated stinkbug, and at this time there are no organic control measures beyond attempts at mass 

trapping. Research into organic control options for both these invasive pests, and others, is critical so 

that organic growers can integrate controls into their organic systems. Prevention is critical. Because 

invasive insect species lack native predators, the organic community needs more information on their 

biology in order to implement prevention strategies before they become established and are more 

difficult to control.

8. Nutrition in Organic Crops 

How do organic production and shipping methods (including methods of production, handling, and time 

in transport) influence the nutritional quality, taste, palatability, and ultimately preference for 

organic vegetables and fruits? There is a lack of sound, rigorously conducted studies of this kind. How 

can growers and handlers retain nutrition through post-harvest handling and transportation? 

Additionally, can providing organic producers information on soil biology and soil nutrient composition 

help improve nutrition? Finally, more studies are needed examining how organic crops compare to 

conventional crops with regards to nutritional value.

11. Side-by-Side Efficacy Assessments of Organic Inputs 

During its five-year review of sunset materials on the National List and in the evaluation of newly 

petitioned materials, the NOSB often lacks sufficient information of the effectiveness of these materials 

as compared with other synthetics on the National List, natural materials, and cultural methods. Sideby-side trials with approved organic inputs, both synthetic and natural, and cultural methods to evaluate 

efficacy would strengthen the review process and provide growers with valuable information in pest and 

disease management decisions. The NOSB specifically requests collaboration with the Minor Crop Pest 

Management Program Interregional Research Project #4 (IR4) to include materials on the National List in 

their product trials. Such studies would help inform the NOSB review process of sunset materials and to 

determine if materials are sufficiently effective for their intended purpose, particularly when weighed 

against the natural and cultural alternatives.

NOSB October 2019 proposals and discussion documents Page 127 of 230
Handling

1. Chlorine Materials and Alternatives 

The three chlorine materials currently allowed for use in organic agriculture are widely used in farming 

and handling to clean and disinfect equipment, surfaces, and produce. There have been some concerns 

raised about these materials and their impact on the environment and human health when/or if they 

form trihalomethanes and other toxic compounds. New FDA regulations on food safety (Food Safety 

Modernization Act) and best management practices for cleaning in handling operations both require a 

suitable level of cleanliness and disinfection to prevent pathogens from entering the food supply. 

Producers and handlers are looking for alternatives to chlorine while continuing to provide a safe end 

product to their customers and the consumer. Addressing food safety while adhering to the 

fundamental organic principles involving human health and environmental impact is a concern. 

The organic industry needs better information on how either alternative materials or appropriate 

chlorine materials are best suited for a specific use and control measure. This is especially important in 

determining if the industry can move away from the use of chlorine compounds in the future.

Points of consideration for future research activities:

• Comparison of alternatives to chlorine such as: citric acid, hydrogen peroxide, ethanol, 

isopropanol, peracetic acid, and ozone. How would each compare to the different chlorine 

materials for specific uses? The strengths and weaknesses would need to be considered.

• Potential human health and environmental impacts of each chlorine material versus the possible 

alternative materials listed above. Are there ways that these impacts can be mitigated and still 

allow the material to work as needed?

• Determination of which of the above-mentioned alternatives would NOT be a suitable substitute 

for chlorine. What specific uses and/or conditions would this apply to?

• Identification of practices that could be used to help reduce the formation of trihalomethanes in 

those specific situations where chorine is the best material to use.

• Could the rotation of materials for cleaning and disinfecting help lower the risks from chlorine 

materials and still be effective in providing the desired control of pathogens?

• Research on the absorption of chlorine by produce from its quantity and use in wash tanks, 

including information about amount of time of exposure. Would this be a persistent residual 

effect or temporary (if temporary – how long is it a viable residue), and would it be harmful if 

consumed at these levels?

2. Celery Powder

Celery Powder is used in a variety of processed meat product (hot dogs, bacon, ham, corned beef, 

pastrami, pepperoni, salami, etc.) to provide “cured” meat attributes without using prohibited nitrites 

(note: products must still be labeled “uncured”). Celery powder is naturally high in nitrates that are 

converted to nitrites during fermentation by a lactic acid culture. It has proven difficult to produce 

celery powder under organic production practices with sufficient levels of nitrates for cured meat 

applications. Are there growing practices or regions that could produce celery under organic conditions 

that would yield a crop with sufficient nitrate content for cured meat applications? Are there 

agriculturally derived substances (other than celery) that could be produced under organic production 

practices that provide nitrate levels sufficient for cured meat product applications of comparable 

quality?

3. Alternatives to Bisphenol A (BPA) 

The Handling subcommittee is examining the issue of whether to prohibit BPA in packaging materials 

used for organic foods in light of direct evidence that these uses result in human exposures and 

NOSB October 2019 proposals and discussion documents Page 128 of 230
mounting evidence that these exposures may be harmful. There is a need for increased research about 

alternatives for the linings of cans and jars used for organic products that do not result in human 

exposures and health risks.

Materials/GMO

In previous years, the Materials subcommittee has prioritized the Reduction of Genetically Modified 

Content of Breeding Lines (2013) and Seed Purity from GMOs (2014). These issues are currently being 

addressed through a Genetic Integrity of Seeds Ad Hoc Working Group. 

1. Fate of Genetically Engineered Plant Material in Compost

What happens to transgenic DNA in the composting process? Materials such as cornstalks from GMO 

corn or manure from cows receiving rBGH are often composted, yet there is little information on 

whether the genetically engineered material and traits break down in composting process. Do these 

materials affect the microbial ecology of a compost pile? Is there trait expression of Bt (bacillus 

thuringiensis) after composting that would result in persistence in the environment or plant uptake? 

2. Integrity of Breeding Lines and Ways to Mitigate Small Amounts of Unwanted Genetic Material

Are public germplasm collections that house at-risk crops threatened by transgenic content? Breeding 

lines may have been created through genetic engineering methods such as doubled haploid technology, 

or they may have had inadvertent presence of GMOs from pollen drift. The extent of this problem 

needs to be understood. 

3. Assess the Genetic Integrity of Organic Crops At Risk (New in 2019) 

Develop then implement methods of assessing the genetic integrity of crops at risk in order to quantify

the current state of the organic and conventionally produced non-GMO seed. Such assessments are

needed on the front (seed purchased by farmers) and back end (seed harvested from a farmer’s field) of

the production chain as well as on points of contamination in the production chain. 

4. Prevention of GMO Crop Contamination: Evaluation of effectiveness

How well are some of the prevention strategies proposed by the NOSB working to keep GMOs out of 

organic crops? For instance, how many rows of buffer are needed for corn? How fast does 

contamination percentage go up or down if there are more or fewer buffer rows? 

Other examples could be whether cleanout of combines and hauling vehicles reduces contamination 

using typical protocols for organic cleaning, whether situating at-risk crop fields upwind from GMO crops 

can reduce contamination, and what the role may be of pollinators in spreading GMO pollen. 

Lastly, research is needed on a mechanism to provide conventional growers incentives to take their own 

prevention measures to prevent pollen drift and its impact on organic and identity-preserved crops. This 

is policy research rather than field research but is equally as important. 

5. Testing for Fraud: Developing and implementing new technologies and practices

New technologies, tests, and methodologies are needed to differentiate organic crop production from 

conventional production to detect and deter fraud. Testing to differentiate conventional and organic 

livestock products, for example omega 3 or other indicators, is also needed. Additional tools to identify

fraudulent processed and raw organic crops require research to combat this problem. Current 

methodologies include pesticide residue testing, in field soil chemical analysis, and GMO testing. Areas 

in need of further testing methodology include phostoxin residues, fumigant residues, carbon isotope 

rations for traceability, validating nitrogen sources using nitrogen isotope rations, or other experimental 

NOSB October 2019 proposals and discussion documents Page 129 of 230
testing instruments that can be utilized to distinguish organic raw and/or processed crops from 

conventional items. Additionally, there is a need to develop rapid detection technologies for adaptation 

to field-testing capacities. 

General

1. Increasing Access to Organic Foods 

What factors influence access to organically produced foods? Individual-based studies are needed to 

assess the constraints to accessing to organic food. Research should be funded that builds on an 

understanding of constraints by asking what community, market, and policy-based incentives would 

enhance access to organic foods.

2. Barriers to Transitioning to Organic Production 

What are the specific production barriers and/or yield barriers that farmers face during the three-year 

transition period to organic? Statistical analysis of what to expect economically during the transition is 

needed to help transitioning growers prepare and successfully complete the transition process.

Subcommittee Vote: 

Motion to adopt the proposal on 2019 NOSB Research Priorities

Motion by: Dave Mortensen

Seconded by: Lisa de Lima

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

 

NOSB October 2019 proposals and discussion documents Page 130 of 230
National Organic Standards Board

Materials Subcommittee Discussion Document

Marine Materials in Organic Crop Production 

February 12, 2019 

NOTE:

The discussion document on Marine Materials in Organic Crop Production was presented at the April 

2019 NOSB meeting and is being posted a second time for additional comment. It is identical to the April 

2019 version with the exception of the addition of question #8 (page 11).

SUMMARY:

At its Fall 2018 board meeting, the NOSB explored a means of addressing the environmental impact of 

harvesting marine algae1 for use in organic crop production inputs through a proposed requirement that 

marine algae under §205.601 (j)(1) aquatic plant extracts and other nonsynthetic uses be certified

organic. This discussion document highlights the public comments received, presents the various 

methods proposed, and puts forth additional discussion questions for stakeholders in anticipation of a 

fall 2019 proposal.

BACKGROUND:

The Organic Foods Production Act National List criteria require, among other things, that materials not 

be harmful to the environment (7 USC 6517(c)). The NOSB has received extensive public testimony over 

the past several years regarding overharvesting of many marine algae species and the potential for 

contamination and harm to ecosystems. Stakeholders have agreed that organic agriculture should not 

contribute to this problem. The NOSB is exploring the best means of accounting for and minimizing the 

environmental impact of marine algae used in organic crop production inputs. This discussion document 

reviews the various methods that have been suggested to achieve that goal in hopes of identifying a 

proposed change to the standards that will be supported by a diverse organic community.

For detailed information on the relevant areas of the rule, please see the Material Subcommittee’s Fall 

2018 Discussion Document. 

PUBLIC COMMENT2

:

A spectrum of written and oral public comments was received, from support for organic certification, to

those stating that marine algae should not be harvested at all for use in organic crop inputs due to 

negative environmental effects, to those concerned about the feasibility of applying organic certification 

to a crop input. Despite the range of views, there was broad agreement on the importance of working 

on this issue. 

1 For the purposes of this document, the term “marine algae” is used to refer to aquatic plants, marine plants, 

seaweed, and marine vegetation. 2 For a summary of public comments of NOSB documents on this topic prior to Fall 2018 and for a review of the 

2016 Technical Report, please see the Materials Subcommittee’s Fall 2018 Discussion Document. These cover 

issues of overharvesting, selective harvesting, and cultivation.

NOSB October 2019 proposals and discussion documents Page 131 of 230
Authority to Require Certification for an Ingredient in an Organic Crop Input:

Some commenters questioned the authority of the NOSB to require organic certification of a crop input 

ingredient. One commenter explained that inputs are not under §205.100 which outlines what must be 

certified. Another said that while they understood the positive intentions of the proposal, they 

opposed applying §205.207 to crop inputs as they understand that section to apply only to crop outputs. 

Some worried about a domino effect that might result in requiring organic certification on a crop input 

ingredient. One stated: 

Marine materials harvested for use as an agricultural input should not be equated to the 

definition of a wild crop or an agricultural product when its purpose is not for human or livestock 

consumption. Requiring the certification of crop production materials that are not intended for 

human or livestock consumption sets a precedent for all agricultural inputs that are marine (or 

terrestrial) plant-based.

One commenter expressed the sentiment that “certification of inputs has been found to be outside of 

the scope of the NOP as established by OFPA”. These commenters noted the proposed 

recommendation would require the certification of “inputs to an input”. One commenter thought this

would conflict with NOP’s guidance that inputs cannot be certified. They asked if certification of the 

input’s formulator would also be required or if it would be deemed sufficient to check the certification 

of the marine algae ingredient during a Materials Review Organization’s review of a brand name 

product. 

These concerns were answered in detail by another commenter:

...Organic certification under the crop or wild crop standards should be required only of the 

aquatic plant ingredient within a formulated crop input. Handlers that further process and/or 

formulate the organic aquatic plants into final crop fertility input products should not be 

required to be certified.

This approach is similar to livestock feed additives that contain agricultural ingredients, in which 

the agricultural ingredient must be organic, but the final formulated product is not required to 

be certified as a processed product. As required by §205.237(a), agricultural ingredients 

included in the ingredients list for livestock feed additives and supplements must be certified 

organic. However, there is no requirement that that handlers that use organic agricultural 

ingredients in the formulation of final feed additive product have to be certified organic. 

This approach will avoid complications that might arise from crop fertility inputs being certified 

organic under NOP, which has historically excluded crop input materials from its scope of 

certification and enforcement. Crop fertilizers and pesticides are generally considered to be 

outside of NOP’s scope of organic certification because they are not intended for human or 

livestock consumption, and therefore do not meet NOP’s definition of “agricultural product” at 

§205.2. Furthermore, it would be confusing and unrealistic to expect that formulated crop input 

products meet organic certification for processed products in terms of permitted ingredients 

and organic product composition requirements.

Clarification on the requirements for labeling crop inputs that contain organic ingredients will 

also be needed. NOP regulates the term “organic” as it applies to agricultural products, which 

has historically only included products intended for livestock or human consumption. Thus, NOP 

does not have enforcement authority over organic claims on fertilizers, soil amendments, and 

other crop input materials (i.e., fertilizers that are not certified organic can still be marketed as 

NOSB October 2019 proposals and discussion documents Page 132 of 230
“organic” and without violating NOP regulations). Certifiers will not be able to use organic claims 

on crop inputs as a means of verify organic status and must obtain proper organic certification 

documents for the aquatic plant ingredient to verify organic status.

Several commenters said verifying the organic status of an ingredient is not onerous, and that requiring 

organic certification of the marine algae ingredient would be similar to the verification of molasses as an 

organic input. Others explained that §205.207 is already being used to certify marine algae for human 

food, as livestock feed, and as a crop input ingredient. There are already a number of crop input 

products on the market that contain a certified organic marine algae ingredient. A manufacturer of 

organic fertilizers shared support for additional guidance and shared that they use certified organic kelp 

meal for their products.

Effectiveness of Using Organic Certification to Address Environmental Impact: 

There were a broad range of opinions as to whether requiring organic certification is the right means to 

ensure that the harvest of wild marine algae is not harmful to the environment. Some producers of crop 

input products using marine algae were satisfied with the status quo, saying that current government 

standards are sufficient. A manufacturer harvesting marine algae off the coast of Mexico said they are 

adequately regulated through permits that stipulate the methods and quantities of harvest. Another 

producer noted that while some government regulations limit harvest rates, no government entities do 

on-site boat inspections. Government harvest limits and reviews are performed off-site and through 

paper trail audits, unlike the organic certification process which involves on-boat inspection of harvest 

locations, among other areas. The producer emphasized that it is not in their interest to over-harvest 

and in their case, scientists are hired to prepare and implement management plans. Certain producers 

of rockweed currently certify some of their harvest to the wild crop standard, and one testified that they 

could expand organic certification to all of their harvest. 

A substantial number of residents in Maine expressed reservations about habitat loss, by-catch, 

frequency of harvest, and re-growth rates with mechanical harvesting of rockweed (Ascophyllum 

nodosum). Some said the term “sustainable harvest” fails to recognize the habitat role of rockweed. A 

number were affiliated with wildlife refuges and conservation areas, and they asserted that rockweed in 

particular, cannot meet the criteria for certification under §205.207 because of ecosystem damage 

caused by large biomass removal. One former wildlife refuge manager said that state and federal 

officers cannot fully regulate and police mechanized harvest boats. A landowner documented that two 

different companies harvested rockweed off of his property within 18 months of each other, despite his 

requests that they not. Some commenters said that organic certification of rockweed pushes harvesters 

into conservation areas and offered first-hand experiences observing rockweed harvested repeatedly 

from preserves. Some commenters from Maine requested that rockweed be listed as a prohibited 

natural on §605.602.

A number of commenters stated that trying to use organic certification would be inadequate to resolve

the environmental impact of harvesting. A commenter stated:

Currently, the standards are not detailed enough to meet the needs of the seaweed populations, 

let alone protecting the ecological community from which they are taken. It may be necessary 

for the NOSB to develop recommendations for new regulations concerning the wild harvest of 

marine plant species for use in organic to best ensure that they meet the needs of seaweed 

populations and the surrounding benthic and trophic communities from which they are taken.

NOSB October 2019 proposals and discussion documents Page 133 of 230
At this time, we are concerned that certifiers that certify seaweed harvest as organic lack the 

expertise to make the judgement that harvesting is not negatively impacting the ecosystem. If 

they are using standards of the local states, these fall short, as they were crafted by the industry 

using heavy lobbying. Therefore, even organic seaweed may still be harvested in a way that 

alters the ecological balance to an unacceptable degree. 

One commenter who supported the reasoning of looking to organic certification as a means of 

addressing the environmental impact of marine algae harvesting, noted that they agreed:

with the subcommittee’s logic of using existing organic certification tools as a means of verifying 

sustainable production practices. Organic is the strongest and most regulated food system in 

the world, so it is logical to use our existing standards and verification processes to ensure that 

crop materials are produced and harvested in a manner that would not be harmful to the 

environment. Although it is unprecedented for the NOP standards to require organic status of 

crop input materials, it is not without precedent in other international organic standards. For 

example, the Canadian Organic Standards require organic status of some crop inputs, such as 

molasses (shall be organic), alfalfa meal and pellets (shall be organic if commercially available) 

and oilseed meals (shall be organic if commercially available).

Therefore, in short, it is feasible to require and achieve organic certification of aquatic plants 

under the existing NOP regulations. Additional complexities lie in the details of whether organic 

certification is feasible as a solution for achieving the subcommittee’s intended sustainability 

goals, and if so, whether it is feasible for the organic industry to build up sufficient organic supply 

to accommodate the needs of organic producers.

Additionally, the commenter pointed out that both the crops certification scope and the wild crops 

certification scope prohibit the destruction of the environment. §205.200 requires that crop producers 

“maintain or improve the natural resources of the operation” while §205.207(b) requires that wild crops 

be “harvested in a manner that ensures that such harvesting or gathering will not be destructive to the 

environment and will sustain the growth and production of the wild crop”. 

Alternatives to Organic Certification to Address Environmental Impact: 

It is important to emphasize that despite the diversity of opinions, there was near unanimous support 

for addressing the environmental impact of marine algae harvesting. This varied from general 

statements supportive of the concept of sustainable harvesting to specific suggestions for alternative 

means of verification. In addition to expressed support for requiring organic certification of marine 

algae ingredients used in organic crop inputs, other actionable positions were: 1) limited or no harvest 

of marine algae for organic crop inputs, 2) exploring existing third-party standards for “sustainable” 

harvesting, and 3) annotations to material listings within the National List of Allowed and Prohibited 

Substances.

1) Limited or no harvest of marine algae for organic crop inputs – Some commenters asserted that there 

is more to be gained from saving than exploiting this resource, and there are populations that are 

endangered or in decline that cannot be sustainably harvested. Some asked why farmers are using 

marine algae as a fertilizer and encouraged seeking alternatives that could replace it. Some suggested 

looking at invasive aquatic plant species as an alternative. Others explained that freshwater algae do 

not contain the same properties. One commenter suggested that it is more appropriate for organic 

farmers to source nutrients from waste streams rather than harvesting an input from a wild, native 

ecosystem. A few recommended allowing only farmed marine algae, particularly farmed kelp, for crop 

inputs. 

NOSB October 2019 proposals and discussion documents Page 134 of 230
Others noted that organic crop inputs containing marine algae are widely used by growers and include 

dried, liquid, and whole, unprocessed formulations. Some coastal growers use marine algae as a mulch. 

One commenter described that: 

It is not uncommon for organic farmers in New England to acquire seaweed from local 

municipalities that collect it from public beaches after storms. This “everybody wins” situation 

would not seem to present significant risk to adjacent aquatic ecosystems. Moreover, it seems 

unlikely that a municipality would bother with organic certification in order to ensure that 

organic farmers would be able to use the seaweed. 

2) Exploring existing third-party standards for “sustainable” harvesting – Quite a few commenters 

suggested looking to third party sustainability standards to “explore the opportunity of integrating 

aspects of other standards or references into the NOP regulations or guidance”. This could result in

“identifying certain other standards as equivalent to NOP for the purposes of ensuring sustainable 

harvest of aquatic plants for use in crop inputs”. An annotation could allow for “multiple options of 

third-party verifications, including organic”. One commenter recommended that “a better alternative to 

organic certification for aquatic plant input materials may be phasing in a requirement that NOSB should 

consider establishing a goal of marine materials be sourced from third-party verified and/or certified 

sustainable fisheries in 10 years”. 

As one public commenter noted, however, the term “sustainable harvest” has different meanings across 

stakeholder groups. For example, some third-party standards focus on vegetative regrowth, but 

“because of the many roles that marine algae play in the ecosystem, standards should not be based on 

the level of disturbance that can sustain a harvest (recovery of biomass), but on recovery of ecosystem 

function and structure”. 

3) Annotations to material listings within the National List of Allowed and Prohibited Substances – Rather 

than requiring that marine algae ingredients in crop inputs be certified organic, one commenter 

recommended adopting the language at §205.207 and annotating the relevant listings. As such, 

annotations would be made under §205.601 (j)(1) for synthetic inputs and under §205.602 for 

nonsynthetic inputs:

Marine algae should be listed on §205.602, prohibited nonsynthetic crop inputs, with the 

annotation, “unless harvested from a designated area that has had no prohibited substance, as 

set forth in §205.105, applied to it for a period of 3 years immediately preceding harvest and 

harvested in a manner that ensures that such harvesting or gathering will not be destructive to 

the environment and will sustain the growth and production of the population of the species”. 

Another commenter supported “the development of guidelines for seaweed harvested for fertilizer 

production, similar to compost, where certifiers verify that the product is made according to the NOP 

rules” and suggested that “this could be managed with the development of an annotation for seaweed 

under §205.601 (j)(1)”. 

Need for Guidance: 

Any requirement for organic certification of marine algae input ingredients would have to be 

accompanied by NOP guidance on how to apply the standards to a marine environment. It was 

observed that the wild crop standards do not define what is meant by “not destructive to the 

environment”. Suggestions included strengthening the interpretation of §205.207 through guidance 

developed with marine biology experts. Others noted that a certifier’s ability to determine if a harvest is 

destructive to the environment depends on his/her knowledge of marine ecology. One harvester and 

NOSB October 2019 proposals and discussion documents Page 135 of 230
manufacturer of rockweed products for livestock feed and soil conditioners believes that the current 

standards “leave too much room for individual interpretation by certifying agents that are not 

necessarily qualified to assess the health of localized or coastwide marine environments”. Several 

commenters illustrated that contaminants in the ocean are more mobile, presenting unique challenges 

to certifying that the crop hasn’t come in contact with prohibited substances. Some specific suggestions 

included requiring documentation of the locations, inputs, and methods of harvest. Guidance should 

make clear that conservation areas should not be harvested. 

A commenter provided the following specific examples of how to expand guidance through “Marine 

Algae Harvest Guidance”:

Documentation should occur before and after each marine algae harvest for all biodiversity: the 

seaweed itself, the bycatch from the harvest, and the wildlife that use seaweed as perches for 

hunting and cover from predators. For the seaweed, documentation of the three-dimensional 

structure in the seaweed bed (clump density, clump height, clump biomass, and branching) 

should be conducted. For bycatch, the harvester simply should record how much they had. For 

wildlife, documentation should include a survey of birds and marine mammals using the 

seaweed.

In looking to other standards, one commenter suggested a “working group could determine whether 

existing [...] standards align 100% with the national organic standards, and if not, which elements may 

need to be added or modified in order to ensure ocean-sources inputs meet NOP standards”. 

Recommendations could then be about “how to integrate [other] standards, plus any additional 

elements, into NOP standards, guidance, or instruction”. 

Another commenter noted that “the health of vertebrate wildlife (birds and fish species) also depends 

on seaweed beds”. They suggest guidance should elucidate how wildlife is maintained when marine 

algae bed harvesting occurs. They recommend “an independent estimate of bird and other wildlife use 

of seaweed beds before and after harvest in each harvest area” in order to “verify that wildlife is being 

“maintained” in the harvest area”. Additionally, they recommend field staff with marine biology training 

perform the certification of marine algae. 

Feedback on the Discussion Document Questions: 

The fall 2018 Discussion Document sought input on four questions. Extensive comments were received 

on the first question regarding the feasibility of requiring all seaweed harvested for use in organic crop 

production to be certified to the wild crop standards, and these are discussed above. There were 

limited responses on the question to certifiers currently certifying marine materials to the wild crop 

standard asking how they verify that biodiversity is conserved and how wildlife are maintained in the 

harvest areas, with the exception of one certifier who provided extensive information, including a link to 

their process for Certifying Sea Vegetables (an excerpt of which can be found in the Appendix). Mixed 

comments were reported as to the difficulty of listing species on a label, with some saying it would be 

challenging and others saying it is possible and already being done. There was widespread support to 

develop a working group for additional guidance on wild cropped and farmed marine algae and to clarify 

the definition and measurement of “not destructive to the environment”. There seemed to be limited 

potential to replace marine algae with freshwater materials for crop production inputs due to the 

particular properties of marine species. 

Other Comments: 

A number of commenters advised a phase-in period to allow adequate time for input producers to come 

into compliance for any requirement of organic certification or third-party standards. A commenter 

NOSB October 2019 proposals and discussion documents Page 136 of 230
remarked that the rule requiring that livestock be fed organic kelp allowed for a twelve-month phase-in, 

and a phase-in for any rule requiring organic certification of marine algae should be at least as long. 

Another suggested examining commercial availability to ascertain an appropriate phase-in period.

DISCUSSION:

The goal of this work agenda item is to find the most effective and realistic means of addressing a 

complicated issue. No single solution will be satisfactory to all, nor will it be able to resolve all areas of 

conflict. Despite of the different opinions, there is consensus on the importance of ensuring that marine 

algae harvesting “maintains or improves the environment”. The NOSB aims to bring a proposal forward 

this fall with a recommendation for meeting the environmental impact criteria. 

Questions of Jurisdiction: 

As noted in the previous section, there were some concerns 1) that it would be difficult for certifiers to 

verify organic claims for marine algae in crop inputs in the absence of NOP purview over fertilizer 

products and 2) about precedent setting. 

Marine algae are currently treated as an agricultural “crop” for livestock feed and human consumption, 

and they are being certified to the wild crop or crops standard in each instance. Indeed, in some cases 

the same boat may harvest the same species of marine algae for both certified organic livestock feed 

and for non-certified crop inputs. As a point of clarification, any NOSB recommendation would only 

require that the marine algae ingredient be certified organic, not the entire crop input or product. 

Labels would list the certified organic marine algae ingredient(s). Certifiers and Material Review 

Organizations would look for the marine algae ingredient’s organic certificate to accompany a product 

and could also use the Organic Integrity Database to verify production. Certifiers would perform the 

verification of agricultural ingredients in fertilizers the same way they already do for agricultural 

ingredients in livestock feed additives.

Several stakeholders cautioned that requiring organic certification of marine algae ingredients in organic 

crop inputs could lead to a similar requirement in other crop input materials. To be clear, that would 

not be the intention nor the focus of any proposal to require organic certification of marine algae 

ingredients; nor is the objective to remove tools or inputs from farmers. Opting for organic certification 

would use an existing standard and verification process to meet the requirement that already exists, 

namely that materials not be harmful to the environment. 

Environmental implications form part of the NOSB's criteria when examining new petitioned synthetic 

materials for potential inclusion on the National List and when reviewing the continued listing of 

materials during the sunset process. Indeed, the issue of environmental impact in marine algae

harvesting came to the NOSB's attention during the 2015 sunset review process. 

The proposed requirement of organic certification for marine algae ingredients is a means of addressing 

conflicts over the environmental impact of harvesting these species, but it does not necessarily follow 

that organic certification would be the right mechanism to account for environmental impact in other 

crop inputs.

The environmental impact of natural materials used in organic production receives comparatively little 

consideration simply because they do not undergo the same review process as synthetic materials. Yet 

NOSB October 2019 proposals and discussion documents Page 137 of 230
the regulations specifically allow for the prohibition of natural materials "if the use of such substances 

would be harmful to human health or the environment" (7 USC 6517(c)). From this we understand that 

natural inputs should also minimize environmental impact. Natural input materials should not be 

exempt from deliberations of environmental impact simply because they do not go through a petitioned 

material and subsequent sunset review process. 

There are few crop input ingredients that are themselves living organisms harvested directly from wild 

native ecosystems. The question posed by the NOSB of petitioned materials--are there any adverse 

impacts on biodiversity--arguably assumes a unique accountability when those input materials 

themselves (in this case, marine algae) form part of the biodiversity of a wild native ecosystem.

Identifying the Right Tool to Address Environmental Impact: 

The status quo does not provide a means of verifying that marine algae inputs are not harmful to the 

environment. Can either the crop or wild crop organic standards adequately define, measure, and verify 

that through guidance? Should all or part of a third-party verification standard be adopted through an 

annotation? Should an annotation be developed that stipulates how marine algae should be harvested 

to meet the wild crop standard but without the requirement of certification? 

Throughout the NOSB’s Discussion Documents on this issue, numerous commenters have suggested that 

there may be some species, regions, and/or harvest methods for which a limited or prohibited harvest 

should be recommended. While this could inform future NOSB work, that is not within the capacity of 

this current discussion document and proposal effort. Additionally, a small number of commenters said 

that marine algae harvests are “sustainable” without further action. In the absence of a universally

agreed upon definition, measurement, and enforcement of sustainable harvest in marine algae, making 

claims related to the term are difficult to support. 

There are several independent non-profit organizations with third party certification services and 

ecolabels that certify “sustainable seaweed”. Much of the focus has historically been on fisheries3

, 

though recent efforts have launched marine algae certification programs. The first two listed below

certify both farmed and wild harvested marine algae, while the third certifies only farmed marine algae. 

Excerpts from these standards can be found in the Appendix.

1. The Marine Stewardship Council (MSC) has traditionally focused on standards for seafood products; 

however in 2017, MSC and the Aquaculture Stewardship Council (ASC) launched “a joint standard for

environmentally sustainable and socially responsible seaweed production” under the ASC-MSC Seaweed 

Standard. These standards contain 31 performance indicators under five principles: sustainable wild 

populations; environmental impact; effective management; social responsibility; community relations 

and interactions. 

Sustainable wild populations: Seaweed harvesting and farming must be conducted in a manner 

that does not lead to depletion of the exploited wild populations. For depleted populations, 

harvesting operations must be conducted in a manner that demonstrably leads to their 

recovery. Where appropriate, stock status, harvest strategy, and the genetic impact of the 

assessment site on the wild stock are also assessed. 

3 For example, see The Monterey Bay Aquarium’s Seafood Watch list of recommended Eco-Certifications for 

specific farmed and wild fish. These include ASC, Naturland, Global Aquaculture Alliance Best Aquaculture 

Practices, Canada Organic, MSC, and FishWise. For example, FishWise’s vision is promoting “the health and 

recovery of ocean ecosystems by providing innovative market-based tools to the seafood industry, supporting

sustainability through environmentally and socially responsible business practices”.

NOSB October 2019 proposals and discussion documents Page 138 of 230
Environmental impacts: Seaweed harvesting and farming activities must allow for the 

maintenance of the structure, productivity, function, and diversity of the ecosystem (including 

habitat and associated dependent and ecologically related species) on which the activity 

depends. Seaweed operations must also adhere to criteria related to habitat, ecosystem 

structure and function, species status, species management, waste management and pollution 

control, energy efficiency, disease and pest management practices, and introduced species 

management.4

2. Friend of the Sea launched a sustainable marine algae harvesting and farming certification program 

in 2016 that reviews an operation’s: “management system; legal compliance; biomass and 

Environmental Impact Assessment; water monitoring; air emissions monitoring; waste management; 

chemicals and hazardous substances; energy management; social accountability; and traceability”.

3. The Maine Seaweed Exchange has a Seaweed Farmer Certification for farmed marine algae. 

At least three international certification bodies provide specific marine algae standards. Others, like 

Japan, set standards for farmed marine algae5

. Excerpts from these standards can be found in the 

Appendix.

1. The Soil Association Organic Seaweed Standards cover both farmed and wild harvested marine algae

(see page 8 for the standards on wild harvested marine algae).

2. The European Commission Regulation 710/2009 sets “conditions for the aquatic production 

environment and impacts on other species”. 

3. Canadian Organic Standards has standards set out in its “Organic production systems : aquaculture - 

general principles, management standards and permitted substances lists”. 

The suggestion that the NOSB require certification to an existing third-party certification system raises 

questions of jurisdiction. The challenge of adopting a third-party standard rather than simply adapting 

from it is that they cover the social and economic tiers of “sustainability”, such as working conditions 

and wages, which are beyond NOP purview. For the purposes of organic production, “sustainable” 

harvest in marine environments addresses environmental impact. Additionally, any third party would 

need to be both impartial and expert in ocean sustainability. Concern has been raised by some in the 

conservation community that existing third-party standards don’t take an ecosystem-wide perspective. 

There were several suggestions for adopting annotations to §605.601 (j)(1) and §605.602. These 

included 1) adapting and/or elaborating the wild crop standard wording at §605.207 and 2) looking to 

the various third-party standards to identify and adopt sustainability benchmarks. Any annotation 

wording would need to be feasible for Material Review Organizations (MROs) to assess. The challenge 

arises in making an annotation enforceable and verifiable without accompanying certification. Who 

would perform on-site/on-boat inspections of each harvester’s operation to measure and substantiate

that their harvest and management procedures met the annotation criteria without a certification 

process? 

Opting for organic crop certification employs a tool already at our disposal for verification. As one NOSB 

member noted in the fall 2018 board meeting discussion, the only way to ensure compliance with 

environmental standards is regulatory action.

4 The Aquaculture Stewardship Council. “The ASC-MSC Seaweed Standard”. Accessed on January 25, 2019. 

https://www.asc-aqua.org/wp-content/uploads/2017/06/BC2146_ASC-MSC_A4_6pp_ARTWORK_LRES.pdf. 5 See: JONA Organic Standards, “Section 8 Organic Macroalgae Standards”, pg. 40 http://www.jonajapan.org/form/JONA_Standards.pdf. 

NOSB October 2019 proposals and discussion documents Page 139 of 230
The fall 2018 Discussion Document presented a recommended proposal to require that marine algae 

ingredients in organic crop production inputs be certified organic to the wild crop standard under 

§205.207. Based on public comments, that language has been modified to the following (proposed 

language changes are underlined):

§205.601 (j) As plant or soil amendments.

(1) Aquatic plant extracts (other than hydrolyzed) –Extraction process is limited to the use of 

potassium hydroxide or sodium hydroxide; solvent amount use is limited to that amount 

necessary for extraction. Marine algae ingredients must be certified organic. 

and

§205.602 Nonsynthetic substances prohibited for use in organic crop production.

The following nonsynthetic substances may not be used in organic crop production:

(j) Marine algae -- unless certified organic. 

Note that the term “marine algae” in any annotation would be clearly defined to avoid confusion about 

the differences with the more general term used in §205.601 (j)(1), “aquatic plants”. Moreover, it was

proposed by commenters that organic certification could occur under either the wild crop or crops

standard. 

The Role of Guidance: 

Regardless of the recommended action, guidance is necessary. Guidance could borrow from multiple 

standards to improve organic certification or for an annotation. The excerpts from the Appendix: Other 

Certifier and Third-Party Marine Algae Standards can provide a starting reference. The Materials 

Subcommittee’s Fall 2018 Discussion Document offered some guidance evaluation questions and 

parameters obtained from public comments. 

In the case of requiring organic certification, guidance is needed to explain what is meant by “not 

destructive to the environment and will sustain the growth and production of the wild crop” (§605.207 

(b)) and “maintain or improve the natural resources of the operation” (§205.200). With an annotation

not tied to certification, guidance would be required to define and provide measurement tools for 

environmentally “sustainable” harvesting.

Some said certifiers don’t typically have the skills needed to certify marine algae to the wild crop 

standard. There are certifiers already doing this; however, there is undoubtedly a need for additional 

guidance and explanation as to how to apply the standards to a marine environment. Certifiers should 

be qualified through adequate training and education.

CONCLUSION:

While this is a new way of looking at a wild harvested crop input, that does not mean it is outside of the 

scope or purview of the NOSB. Organic agriculture is about more than simply limiting the use of 

synthetic ingredients. Farmers and consumers rely on the NOSB and the NOP to affirm the 

environmental integrity of organic production, including inputs used. Although finding a middle ground 

is always challenging, failing to do so will not resolve this issue. There are strong reasons for using the 

existing instrument of organic certification for marine algae ingredients; nevertheless, the NOSB is 

interested in obtaining further suggestions from stakeholders. 

NOSB October 2019 proposals and discussion documents Page 140 of 230
DISCUSSION QUESTIONS:

1. If you are not in support of requiring organic certification, what approach do you support? 

Please describe the method for defining, measuring, and most importantly, enforcing, that the 

harvest would not be destructive to the environment under an alternative approach. 

2. Some existing wild harvest marine algae standards from other certifiers and third-party entities 

are listed in the Appendix. Please comment on strengths in these standards that could be 

adapted for NOP guidance. Please identify areas of weakness or areas that are not covered.

3. What existing certification or private standards to support marine algae harvest sustainability 

have not been included in this document or the Appendix that can help inform the NOSB’s 

understanding of the current work being done? 

4. How many crop input products approved for use in organic production currently contain 

certified organic marine algae ingredients? 

5. Are there any crop input products utilizing or developing farmed marine algae?

6. Are there enough certifiers able to offer certification services to meet the needs of the crop 

fertilizer markets if organic certification were required? If organic certification were required of 

marine algae ingredients, what would be an appropriate phase-in time to allow markets to meet 

the demand?

7. The NOSB hopes to convene an expert panel at the fall 2019 board meeting to include a marine 

algae harvester for crop inputs, scientist, conservationist, and certifier, among others. What are 

some questions that could be posed to help identify the issues and solutions?

8. What are the standards for evaluating environmental harm? For example, what measures of 

community biodiversity and marine algae species characteristics (density, maximum height, 

girth, area) could be collected pre- and post-harvest? How soon must these variables return to 

baseline to avoid environmental harm?

Vote in Subcommittee: 

Motion to accept the marine materials in organic crop production discussion document 

Motion by: Emily Oakley 

Seconded by: Harriet Behar

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

Approved by Emily Oakley, Subcommittee Chair to transmit to NOSB, May 20, 2019

NOSB October 2019 proposals and discussion documents Page 141 of 230
Appendix of Excerpts from Other Certifier and Third-Party Marine Algae Standards: 

Note: This is not intended to be an exhaustive list and is meant to provide examples and references to 

some existing marine algae certification standards.

This Appendix includes:

A. Soil Association organic seaweed standards Version 1.0 – January 2016

B. European Commission Regulation (EC) No 710/2009 of 5 August 2009

C. Canadian General Standards Board: Organic production systems Aquaculture – General 

principles, management standards and permitted substances lists

D. The ASC-MSC Seaweed Standard

E. Friend of the Sea Certification Criteria Checklist For Seaweed Products: Seaweed Harvesting and 

Farming

F. MOFGA Sea Vegetable Supplement

A. Soil Association organic seaweed standards Version 1.0 – January 20166

SP c. Sustainable harvesting of wild seaweed 

1. You must harvest wild seaweed without significant impact on the aquatic environment. 

2. You must put in place measures that ensure seaweed regeneration, taking into account: 

a. harvesting technique 

b. minimum sizes 

c. minimum ages 

d. reproductive cycles or 

e. size of remaining seaweed. 

3. You must keep records that demonstrate: 

a. the history of harvesting activity for each species in named beds 

b. that the seaweed harvested is wild seaweed and that it is harvested according to these 

standards 

c. that where you harvest seaweed from a shared or common harvest area, the total harvest

complies with these standards.

4. Your records of harvest estimates and sources of potential pollution must provide evidence that you 

are managing the harvesting areas sustainably with no long-term impact.

B. European Commission Regulation (EC) No 710/2009 of 5 August 20097

CHAPTER 1a

Seaweed production

Article 6a

Scope

6 Soil Association. “Soil Association organic seaweed standards Version 1.0 – January 2016”. Accessed on January 

25, 2019. https://www.soilassociation.org/media/5250/sa-seaweed-standards.pdf. 7 European Commission. “Commission Regulation (EC) No 710/2009 of 5 August 2009 amending Regulation (EC) 

No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007, as 

regards laying down detailed rules on organic aquaculture animal and seaweed production”.

NOSB October 2019 proposals and discussion documents Page 142 of 230
This Chapter lays down detailed production rules for the collection and farming of seaweed. It 

applies mutatis mutandis to the production of all multi-cellular marine algae or phytoplankton and 

micro-algae for further use as feed for aquaculture animals.

Article 6b

Suitability of aquatic medium and sustainable management plan

1. Operations shall be situated in locations that are not subject to contamination by products or 

substances not authorised for organic production, or pollutants that would compromise the organic 

nature of the products.

2. Organic and non-organic production units shall be separated adequately. Such separation measures 

shall be based on the natural situation, separate water distribution systems, distances, the tidal flow, 

the upstream and the downstream location of the organic production unit. Member State authorities 

may designate locations or areas which they consider to be unsuitable for organic aquaculture or 

seaweed harvesting and may also set up minimum separation distances between organic and nonorganic production units.

Where minimum separation distances are set Member States shall provide this information to 

operators, other Member States and the Commission.

3. An environmental assessment proportionate to the production unit shall be required for all new 

operations applying for organic production and producing more than 20 tonnes of aquaculture products 

per year to ascertain the conditions of the production unit and its immediate environment and likely 

effects of its operation. The operator shall provide the environmental assessment to the control body or 

control authority. The content of the environmental assessment shall be based on Annex IV to Council 

Directive 85/337/EEC (21). If the unit has already been subject to an equivalent assessment, then its use 

shall be permitted for this purpose.

4. The operator shall provide a sustainable management plan proportionate to the production unit for 

aquaculture and seaweed harvesting.

The plan shall be updated annually and shall detail the environmental effects of the operation, the 

environmental monitoring to be undertaken, and list measures to be taken to minimise negative 

impacts on the surrounding aquatic and terrestrial environments, including, where applicable, nutrient 

discharge into the environment per production cycle or per annum. The plan shall record the 

surveillance and repair of technical equipment.

5. Aquaculture and seaweed business operators shall by preference use renewable energy sources and 

re-cycle materials and shall draw up as part of the sustainable management plan a waste reduction 

schedule to be put in place at the commencement of operations. Where possible, the use of residual 

heat shall be limited to energy from renewable sources.

6. For seaweed harvesting a once-off biomass estimate shall be undertaken at the outset.

Article 6c

Sustainable harvesting of wild seaweed

1. Documentary accounts shall be maintained in the unit or premises and shall enable the operator to 

identify and the control authority or control body to verify that the harvesters have supplied only wild 

seaweed produced in accordance with Regulation (EC) No 834/2007.

2. Harvesting shall be carried out in such a way that the amounts harvested do not cause a significant 

impact on the state of the aquatic environment. Measures shall be taken to ensure that seaweed can 

regenerate, such as harvest technique, minimum sizes, ages, reproductive cycles or size of remaining 

seaweed.

3. If seaweed is harvested from a shared or common harvest area, documentary evidence shall be 

available that the total harvest complies with this Regulation.

NOSB October 2019 proposals and discussion documents Page 143 of 230
4. With respect to Article 73b(2)(b) and (c), these records must provide evidence of sustainable 

management and of no long-term impact on the harvesting areas.

C. Canadian General Standards Board: Organic production systems Aquaculture – General principles, 

management standards and permitted substances lists8

7.2 Wild crops 

7.2.1 An organic wild crop shall be harvested from a clearly defined area or production unit in 

accordance with this standard. Documented evidence that prohibited substances have not been used 

for at least 36 months before the harvest of an organic crop shall be available. 

7.2.2 The operator shall prepare an organic plan (see 4.1, 4.2 and 4.3) that includes: 

a) a detailed description of production areas and harvest methods. If wild crops are harvested 

from a shared or common area, records shall be available to demonstrate that the total harvest 

complies with this standard; 

b) management practices that preserve wild species and avoid disturbance of the environment; 

and 

c) a record-keeping system that meets the requirements of 4.4. 

7.2.3 Harvesting shall be carried out in such a way that the amounts harvested do not cause significant 

impact on the state of the environment. Measures shall be taken to ensure that crops can regenerate. 

Examples of such measures include harvest techniques and tools, minimum sizes, ages, reproductive 

cycles or size of remaining crops. Evidence of sustainable management and of no long-term impact on 

the harvesting areas shall be provided. 

7.2.4 The production zone for wild crops shall be situated in locations where water is not subject to 

contamination by products or substances not authorized for organic production, or pollutants that 

would compromise the organic nature of the production.

D. The ASC-MSC Seaweed Standard9

Certified seaweed operations must be well-managed, environmentally sustainable and socially 

responsible. 

If you decide to begin the audit process, an accredited third party conformity assessment body (CAB) 

will provide an assessment team to independently score your farm or wild harvest operation to some or 

all of the 31 performance indicators (PIs) that make up the ASC-MSC Seaweed Standard. 

8 Canadian General Standards Board- Standards Council of Canada. “Organic production systems Aquaculture – 

General principles, management standards and permitted substances lists”, pg. 23. CAN/CGSB-32.312-2018. 

Accessed on January 25, 2019. http://publications.gc.ca/collections/collection_2018/ongc-cgsb/P29-32-312-2018-

eng.pdf. 9 The Aquaculture Stewardship Council. “Get certified! Your guide to the ASC-MSC Seaweed Standard audit 

process”, pg. 8. Accessed on January 25, 2019. https://www.asc-aqua.org/wp-content/uploads/2017/11/GetCertified-Guide-Seaweed.pdf. 

NOSB October 2019 proposals and discussion documents Page 144 of 230
The number of PIs scored depends on the type of seaweed production system that you use. Your CAB 

will explain exactly which of the PIs will be scored for your operation. 

Table 1: List of performance indicators

Principle 1 Sustainable wild populations

PI 1.1 Stock status 

PI 1.2 Harvest strategy

PI 1.3 Genetic impact on wild stock

Principle 2 Environmental Impacts

PI 2.1 Habitat 

PI 2.2 Ecosystem structure and function

PI 2.3 ETP species

PI 2.4 Other species

PI 2.5 Waste management and pollution control

PI 2.6 Pest(s) and disease(s) and management

PI 2.7 Energy efficiency

PI 2.8 Translocations

PI 2.9 Introduction of alien species

Principle 3 Effective management

PI 3.1 Legal and/or customary framework 

P1 3.2 Decision-making processes

P1 3.3 Compliance and enforcement

Principle 4 Social responsibility

PI 4.1 Child labour 

PI 4.2 Forced, bonded or cumpulsory labour

PI 4.3 Discrimination

PI 4.4 Health, safety and insurance

PI 4.5 Fair and decent wages

PI 4.6 Freedom of association and collective bargaining

PI 4.7 Disciplinary practices

PI 4.8 Working hours

PI 4.9 Environmental and social training

Principle 5 Community relations and interaction

PI 5.1 Community impacts 

PI 5.2 Conflict resolution 

PI 5.3 Rights of indigenous groups 

PI 5.4 Visability, positioning and orientation of farms or water-based 

PI 5.5 Identification and recovery of substantial gear 

PI 5.6 Noise, light and odour 

PI 5.7 Decommissioning of abandoned production units

NOSB October 2019 proposals and discussion documents Page 145 of 230
E. Friend of the Sea Certification Criteria Checklist For Seaweed Products: Seaweed Harvesting and 

Farming 10

3 - Biomass and Environmental Impact Assessment

3.1 In case of seaweed harvesting activity, an assessment of the status of the seaweed and its biomass 

by appropriate research institutes or other recognised institutions unconnected to any harvesting 

and/or processing industries must be undertaken and it must conclude that the seaweed is not 

overexploited nor endangered. [The auditor must make reference to the biomass studies (title, date, 

author).]

3.2 This requirement applies to all harvesting operations and to those farming operations producing 

more than 20 tonnes per year. An EIA or equivalent assessment of the harvesting or farming activity has 

been carried out with a positive outcome by the presiding authority or by other recognized independent 

institute or laboratory. [The auditor must check whether an independent environmental impact 

assessment or equivalent was carried out. The auditor must specify the title, date, author and significant 

conclusions of the inspected EIA or equivalent document. *In case the Organisation is not compliant for 

3.1, it must alternatively be compliant to 3.2 and sub requirements.] 

3.3 In case of non compliance with 3.2, farming activities producing more than 20 tonnes per year must 

alternatively be compliant with the following requirements:

3.3.1 sea-based systems must not imply removal of rocks, corals or other obstructions leading to 

damage to the coastal ecosystem;

3.3.2 sea-based systems must not imply removal of competitive grasses or predators leading to 

damage to the coastal ecosystem;

3.3.3 large scale sea-based farms must not influence coastal water movement in a detrimental 

way. Protection from erosion or other positive impacts would not constitute a non-compliance with this 

requirement;

3.3.4 any multiuser conflict must have been solved positive and allow other users access to the 

sea and to the shore. 

3.3.5 a careful assessment of potential impacts must precede the introduction of any non-native 

species. 

3.3.6 removal of mangroves for farming purposes is prohibited. In case removal has occurred, a 

reforestation program must fully compensate the mangroves degradation occurred and caused by the 

seaweed farming activity.

3.3.7 carrying capacity must have been independently evaluated, considering in particular the 

potential impact of nutrients removal. [The auditor must acquire documented information and 

evidence (text, photos, official documents to be annexed to the audit report) of the environmental 

conditions of the ecosystem prior to the installation and assess whether the site has led to a negative 

impact on the ecosystem.] 

3.4 In case of farming operations of less than 20 tonnes each per year, but more than 20 tonnes on a 

regional or national level, a regional or national level independent assessment must prove compliance 

with requirements 3.3 and sub. The study cannot be older than 5 years. [The auditor must make 

reference to the regional or national level assessment. The auditor must run sample onsite checks at 

small scale producers and produce / report evidence of compliance.] 

10 Friend of the Sea. “Certification Criteria Checklist For Seaweed Products: Seaweed Harvesting and Farming

(Latest update: 19/03/2014)” pgs. 7-9. Accessed on January 25, 2019. 

http://www.friendofthesea.org/public/news/en%20-%20checklist%20fos%20seaweed%2019032014.pdf. 

NOSB October 2019 proposals and discussion documents Page 146 of 230
F. MOFGA Sea Vegetable Supplement11

Part 2. WILD CRAFTED SEA VEGETABLES – Wild Crafted sea vegetables are sea vegetables harvested 

from natural growing areas along ocean coastline. Wild crafted sea vegetables must meet the wild 

crafting requirements of the NOP rule. 

Wild Crafted Sea Vegetable Variety Harvest Method Site Locations (harvest area) 

(Please include each site on 

 the Harvest Area Form.)* 

*Include maps and a Landowner Affidavit, if applicable for each site. On each harvest area map 

designate harvest areas, boundaries, buffer zones, and sources of possible contaminants and prohibited 

materials. 

Part 3. GROWING AREA DESCRIPTION: Cultured and/or Wild Crafted Sea Vegetables 

3.1. Describe the natural environment of the harvest area. List any rare or endangered terrestrial or 

aquatic plants or animals that occur in the harvest area. Lists of rare or endangered plants and animals 

are available from MNAP or MDIFW. 

3.2. Describe methods used to prevent negative impact to the harvest area and monitoring procedures 

used to verify lack of impact on the aquatic ecosystem, water quality and biodiversity. 

3.3. How do your harvest practices ensure the health, sustained growth, and long-term viability of the 

wild crop(s)? 

3.4. Approximately what percentage of the wild crop is harvested at each harvest? Are you aware of 

other harvesters working the same area? 

3.5. List harvester training provided including frequency of trainings and the procedures used to ensure 

your collectors harvest crops in accordance with answers provided above.

3.6. What procedures are in place to prevent contamination from adjoining land/water use or other 

sources of contamination? 

3.7. Describe your record keeping system for wild crop area management, monitoring, harvest and sales.

11 MOFGA Certification Services LLC. “Sea Vegetable Supplement” pgs. 3-4. Accessed on January 25, 2019. 

https://mofgacertification.org/wp-content/uploads/Crop_2019_SeaVegetableSupplement.pdf. 

NOSB October 2019 proposals and discussion documents Page 147 of 230
NOSB October 2019 proposals and discussion documents Page 148 of 230
National Organic Standards Board 

Policy Development Subcommittee Proposal

Policy and Procedures Manual Revision

July 9, 2019 

Introduction and Background 

The PPM was established to assist the Board in the implementation of its duties under OFPA and to 

establish operating procedures and policies for the NOSB. During the period since the last revision 

(October 2016) the Policy Development Subcommittee has been compiling a list of minor revisions and 

suggested changes. The PDS has reviewed these suggested changes and proposes the following as listed 

in the table below. 

Below, please find a marked-up copy of the PPM that has been revised and updated by the Policy 

Development Subcommittee. In addition to some minor clerical changes we have made the following 

changes (noted in red text in the proposal): 

Summary Table of Changes

Section/Page Change

III. D

Page 8

Added to the NOSB Secretary’s duties: To monitor and notify Subcommittee Chairs 

periodically of public comments posted in the open docket between the period when 

the meeting notice is posted in the Federal Register and when the proposals are 

posted (pg 8).

IV. F. 1

Page 20

Clarified language about when the new NOSB Chair takes office to match the 

language that is in VIII. F. 

IV. G. 2

Page 22

Another type of discussion document: Petition material discussion document

IV. H. 

Page 23

Clarified the steps in the material review process for a new petition 

IV. H. 

Page 24

Steps 2 & 3

Added clarifying language about how a Subcommittee determines sufficiency of a 

petition 

IV. H. 

Pages 25 - 26, 

Steps 4 & 7

Added a process for a Subcommittee to develop a discussion document based on a 

petition 

VIII. E.

Page 34

Added an additional bullet point under the section about the policy for public 

communication between NOSB meetings for posting discussion documents and 

proposals between public meetings for review and public comment 

Motion to accept the changes to the Policy & Procedures Manual (PPM)

Motion by: Steve Ela

Seconded by: Tom Chapman

Yes: 5 No: 0 Abstain: 0 Absent: 1 Recuse: 0

Approved by Rick Greenwood, Subcommittee Chair, to transmit to NOSB, July 9, 2019

NOSB October 2019 proposals and discussion documents Page 149 of 230
 NATIONAL ORGANIC STANDARDS BOARD 

 

POLICY AND PROCEDURES MANUAL 

 

 

Adopted October 19, 2002 

Revised August 18, 2005

Revised March 29, 2007

Revised November 30, 2007

Revised May 22, 2008

Revised November 19, 2008

Revised May 6, 2009

Revised November 9, 2009

Revised April 29, 2010

Revised October 28, 2010

Revised April 29, 2011

Revised December 2, 2011

Revised April 11, 2012

Revised April 26, 2016

Revised November 18, 2016

Revised November 18, 2016

NOSB October 2019 proposals and discussion documents Page 150 of 230
NATIONAL ORGANIC STANDARDS BOARD (NOSB)

POLICY AND PROCEDURES MANUAL

Contents

I. INTRODUCTION/PURPOSE.................................................................................................................... 4

A. NOSB VISION STATEMENT.............................................................................................................................. 4

B. NOSB STATUTORY MISSION ........................................................................................................................... 4

C. NOSB MISSION STATEMENT ........................................................................................................................... 4

II. AUTHORIZATION ................................................................................................................................ 5

A. ORGANIC FOODS PRODUCTION ACT OF 1990................................................................................................... 5

B. FEDERAL ADVISORY COMMITTEE ACT ............................................................................................................. 5

C. NATIONAL ORGANIC STANDARDS BOARD CHARTER ........................................................................................ 5

III. NOSB ADMINISTRATION ...................................................................................................................... 5

A. NOSB MEMBERSHIP....................................................................................................................................... 5

B. NOMINATION AND APPOINTMENT PROCESS .................................................................................................. 5

C. RESPONSIBILITIES OF THE NOSB....................................................................................................................... 6

D. NOSB OFFICERS ............................................................................................................................................. 7

CHAIR............................................................................................................................................................ 8

VICE CHAIR .................................................................................................................................................... 8

SECRETARY .................................................................................................................................................... 8

ADMINISTRATIVE TEAM.................................................................................................................................. 8

E. NOSB-NOP COLLABORATION.......................................................................................................................... 9

F. NOSB WORK AGENDAS .................................................................................................................................. 9

G. DESIGNATED FEDERAL OFFICER (DFO) ..........................................................................................................11

H. ADVISORY COMMITTEE SPECIALIST ..............................................................................................................11

I. ADDITIONAL ADMINISTRATIVE ITEMS...........................................................................................................12

J. PROFESSIONAL AND ETHICAL STANDARDS ....................................................................................................13

1) NOSB Member Professional Conduct Standards..................................................................................13

2) Additional Standards of Conduct........................................................................................................14

3) Failure to participate.........................................................................................................................14

K. DECLARATION OF INTERESTS/CONFLICT OF INTEREST ....................................................................................15

IV. SUBCOMMITTEES..............................................................................................................................17

A. STANDING SUBCOMMITTEES .......................................................................................................................17

B. AD HOC SUBCOMMITTEES............................................................................................................................18

C. SUBCOMMITTEE MEETINGS .........................................................................................................................19

D. TASK FORCES...............................................................................................................................................19

E. DUTIES OF SUBCOMMITTEE CHAIRS AND VICE CHAIRS ...................................................................................19

F. TRANSITION OF SUBCOMMITTEE CHAIRS, VICE CHAIRS, AND MEMBERS (NEW AND CONTINUING)...................20

G. PROCEDURES FOR COMPLETING SUBCOMMITTEE PROPOSALS AND DISCUSSION DOCUMENTS .......................21

1. Development of proposals.....................................................................................................................21

2. Types of Proposals ................................................................................................................................22

3. Presenting Subcommittee Proposals and Discussion Documents at NOSB Meetings...................................22

H. SUBSTANCE/MATERIALS REVIEW PROCESS ...................................................................................................22

1. Steps in the material review process for a new petition: ..........................................................................23

2. Changes to annotations or classification of materials...............................................................................27

NOSB October 2019 proposals and discussion documents Page 151 of 230
3. Additional considerations concerning Technical Reviews .........................................................................27

4. Definitions............................................................................................................................................28

V. PRIORITIZATION OF PETITIONS............................................................................................................28

VI. WITHDRAWAL OF A PETITION BY A PETITIONER.....................................................................................29

VII. SUNSET REVIEW PROCESS ..................................................................................................................29

VIII. NOSB PROCEDURES...........................................................................................................................31

A. BOARD MEETINGS .......................................................................................................................................31

B. CONDUCTING BUSINESS...............................................................................................................................31

C. PARLIAMENTARY PROCEDURES....................................................................................................................32

D. NOSB DELIBERATIONS AND RECOMMENDATIONS .........................................................................................32

E. PUBLIC COMMENT.......................................................................................................................................33

F. ELECTION OF OFFICERS................................................................................................................................. 34

G. MISCELLANEOUS PROCEDURES ....................................................................................................................35

1. Invited Speakers ...................................................................................................................................35

2. Surveys Conducted on Behalf of NOSB Subcommittees............................................................................35

IX. REVISIONS TO THE POLICY AND PROCEDURES MANUAL..........................................................................35

X. APPENDICES.....................................................................................................................................36

A. APPENDIX 1: FOUNDATIONS ........................................................................................................................36

1. NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING................................................................. 36

2. NOSB GUIDANCE ON COMPATIBILITY WITH A SYSTEM OF SUSTAINABLE AGRICULTURE AND 

CONSISTENCY WITH ORGANIC FARMING AND HANDLING...............................................................................38

3. NOSB MEMBER DUTIES .........................................................................................................................38

B. APPENDIX 2: FACA FACTS .............................................................................................................................40

NOSB October 2019 proposals and discussion documents Page 152 of 230
I. INTRODUCTION/PURPOSE 

This document provides procedures for the functioning of the National Organic Standards Board

(NOSB) and is designed to assist the NOSB in its responsibilities. This policy and procedures manual 

does not supersede authority or responsibilities as specified in the Federal Advisory Committee Act

or the Organic Foods Production Act (OFPA). NOSB members are encouraged to review this manual 

in depth as well as to become familiar with the OFPA, the USDA organic regulations at 7 CFR Part 

205, and the NOSB Member Guide. Members are advised to periodically review the contents to 

refresh their understanding of the NOSB’s role and duties. NOSB members are entrusted with the 

responsibility to act in the best interests of all members of the organic community and the public at 

large. The NOSB’s success relies upon the ability to understand each other’s respective roles, and to 

develop successful working relationships. 

The primary roles and duties of the National Organic Standards Board (NOSB): 

• Serve as a link to the organic community

• Advise USDA on the implementation of OFPA 

• Propose amendments to the National List of Allowed and Prohibited Substances

• Protect and defend the integrity of organic standards

A. NOSB VISION STATEMENT 

(NOSB Recommendation adopted October 19, 2002, revised November 30, 2007).

The NOSB’s vision is an agricultural community rooted in organic principles and values that 

instills trust among consumers, producers, processors, retailers and other stakeholders. 

Consistent and sustainable organic standards guard and advance the integrity of organic 

products and practices. 

 

B. NOSB STATUTORY MISSION 

(NOSB Recommendation adopted October 19, 2002, revised November 30, 2007).

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))

C. NOSB MISSION STATEMENT 

(NOSB Recommendation adopted October 19, 2002, revised November 30, 2007).

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. 

Key activities of the Board include: 

• Assisting in the development and maintenance of organic standards and regulations

• Reviewing petitioned materials for inclusion on or removal from the National List of 

Approved and Prohibited Substances (National List) 

• Recommending changes to the National List 

• Communicating with the organic community, including conducting public meetings, 

soliciting and reviewing public comments 

• Communicating, supporting and coordinating with the NOP staff 

NOSB October 2019 proposals and discussion documents Page 153 of 230
II. AUTHORIZATION

The National Organic Standards Board (NOSB) is authorized under Section 2119 of the Organic 

Foods Production Act of 1990 (OFPA) (7 U.S.C. 6519), part of the Food, Agriculture, Conservation, 

and Trade Act of 1990 (FACT Act). The OFPA specified that the NOSB be established in accordance 

with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App. 2. 

A. ORGANIC FOODS PRODUCTION ACT OF 1990

The Organic Foods Production Act of 1990 (OFPA) authorizes the Secretary of Agriculture to 

establish a National Organic Standards Board (NOSB) in accordance with the Federal Advisory 

Committee Act 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 OFPA

(OFPA, 7 U.S.C. Section 6518(a)). 

B. FEDERAL ADVISORY COMMITTEE ACT

The Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and its implementing regulations 

(41 CFR Part 101-6.10) govern the creation, operation, and termination of advisory committees 

in the Executive Branch of the Federal Government. The National Organic Standards Board 

(NOSB) is a Department of Agriculture (USDA) non-discretionary advisory committee required by 

the Organic Foods Production Act of 1990, as amended. 

C. NATIONAL ORGANIC STANDARDS BOARD CHARTER

The Federal Advisory Committee Act requires advisory committees to have an official charter 

prior to meeting or taking any action. An advisory committee charter is intended to provide a 

description of an advisory committee’s mission, goals, and objectives. The NOSB charter is 

renewed every two years as a requirement of FACA. The NOSB charter describes the purpose of 

the NOSB 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 OFPA.” 

III. NOSB ADMINISTRATION

A. NOSB Membership 

OFPA specifies the membership composition of the NOSB as follows. The NOSB shall be 

composed of 15 members, of which:

• Four shall be individuals who own or operate an organic farming operation;

• Two shall be individuals who own or operate an organic handling operation;

• One shall be an individual who owns or operates a retail establishment with significant trade 

in organic products;

• Three shall be individuals with expertise in areas of environmental protection and resource 

conservation;

• Three shall be individuals who represent public interest or consumer interest groups;

• One shall be an individual with expertise in the fields of toxicology, ecology, or biochemistry; 

and

• One shall be an individual who is a certifying agent as identified under OFPA, 7 U.S.C.

§ 6518(b)

B. Nomination and appointment process 

(NOSB recommendation adopted June 10, 1999)

NOSB members are appointed by the Secretary of Agriculture to a five-year term. The terms are 

staggered, and the USDA periodically requests nominations to fill upcoming vacancies. Selection 

criteria include the following: 

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• A general understanding of organic principles, and practical experience in the organic 

community, particularly in the sector for which the person is applying

• Demonstrated experience in the development of public policy such as participation on 

public or private advisory boards, boards of directors or other comparable organizations

• Participation in standards development and/or involvement in educational outreach 

activities

• A commitment to the integrity and growth of the organic food and fiber industry

• The ability to evaluate technical information and to fully participate in Board deliberation 

and recommendations

• The willingness to commit the time and energy necessary to assume Board duties

• Not currently serving (or have been elected to serve) on another USDA advisory committee 

or research and promotions council/board during your term

• Not registered as a lobbyist with the federal or state government

NOSB members serve without compensation. NOSB members are reimbursed by the USDA for 

approved travel and associated lodging expenses as determined by official federal government 

guidelines and regulations. In accordance with USDA policies, equal opportunity practices are 

followed in all appointments to the NOSB. Membership shall include to the extent possible the 

diverse groups served by USDA, including minorities, women, and persons with disabilities. 

The USDA prohibits discrimination in all of its programs and activities on the basis of race, color, 

national origin, age, disability, and where applicable, sex, marital status, familial status, parental 

status, religion, sexual orientation, political beliefs, genetic information, reprisal, or because all 

or part of an individual's income is derived from any public assistance program.

C. Responsibilities of the NOSB

(OFPA, 7 USC 6518(k)):

(1) In General. The Board shall provide recommendations to the Secretary regarding the 

implementation of this chapter. 

(2) National List. The Board shall develop the proposed National List or proposed amendments 

to the National List for submission to the Secretary in accordance with section 6517 of this title. 

(3) Technical Advisory Panels. The Board shall convene technical advisory panels to provide 

scientific evaluation of the materials considered for inclusion in the National List. Such panels 

may include experts in agronomy, entomology, health sciences and other relevant disciplines. 

(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. 

(5) Product Residue Testing. The Board shall advise the Secretary concerning the testing of 

organically produced agricultural products for residues caused by unavoidable residual 

environmental contamination. 

(6) Emergency Spray Programs. The Board shall advise the Secretary concerning rules for 

exemptions from specific requirements of this chapter (except the provisions of section 6511 of 

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this title) with respect to agricultural products produced on certified organic farms if such farms 

are subject to a Federal or State emergency pest or disease treatment program. 

Requirements. (OFPA 6518(l)) In establishing the proposed National List or proposed 

amendments to the National List, the Board shall 

(1) review available information from the Environmental Protection Agency, the National 

Institute of Environmental Health Studies, and other sources as appropriate, 

concerning the potential for adverse human and environmental effects of substances 

considered for inclusion in the proposed National List; 

(2) work with manufacturers of substances considered for inclusion in the proposed 

National List to obtain a complete list of ingredients and determine whether such 

substances contain inert materials that are synthetically produced; and 

(3) submit to the Secretary, along with the proposed National List or any proposed 

amendments to such list, the results of the Board's evaluation and the evaluation of 

the technical advisory panel of all substances considered for inclusion in the National 

List. 

Evaluation. (7 USC 6518(m)) In evaluating substances considered for inclusion on the National 

List the NOSB shall consider: 

1. the potential of such substances for detrimental chemical interactions with other 

materials used in organic farming systems; 

2. the toxicity and mode of action of the substance and of its breakdown products or any 

contaminants, and their persistence and areas of concentration in the environment; 

3. the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance; 

4. the effect of the substance on human health; 

5. the effects of the substance on biological and chemical interactions in the 

agroecosystem, including the physiological effects of the substance on soil organisms 

(including the salt index and solubility of the soil), crops and livestock; 

6. the alternatives to using the substance in terms of practices or other available 

materials; and 

7. compatibility with a system of sustainable agriculture. 

Petitions. (7 USC 6518(n)) 

The board shall establish procedures for receiving petitions to evaluate substances for inclusion 

on the List

Sunset Provision. (7 USC 6517 (e)) 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. 

D. NOSB OFFICERS

Three principal officers, Chair, Vice Chair and Secretary, guide the NOSB. The NOSB members 

hold an election each fall at the public meeting to elect these three members.

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CHAIR 

The Chair is responsible for ensuring the integrity of the NOSB process, effectiveness of 

meetings and adherence to NOSB policies and procedures. The primary duties of the 

Chair are as follows: 

• Schedules meetings of the Executive Subcommittee, in collaboration with the NOP

• Serves as a member of, convenes, and facilitates Executive Subcommittee meetings

• Convenes and presides over NOSB meetings 

• Participates in the administrative team meetings

• Drafts NOSB meeting agendas in consultation with Subcommittee chairs and the 

NOP 

• Reviews Subcommittee work agendas 

• Reviews NOSB meeting minutes for accuracy 

• Assists with the annual election of NOSB officers and announces the new officers

VICE CHAIR 

The Vice Chair acts in the absence of the Chair. The primary duties of the Vice Chair are 

as follows: 

• Serves as a member of the Executive Subcommittee

• Participates in the administrative team meetings

• Serves as a member of the Policy Development Subcommittee

• Helps maintain the Policy and Procedures Manual and ensures its accuracy 

SECRETARY 

The primary duties of the Secretary are as follows: 

• Serves as a member of the Executive Subcommittee

• Participates in the administrative team meetings

• Records all NOSB member votes at NOSB meetings, and in collaboration with the 

Advisory Committee Specialist (ACS), circulates that record to NOSB members for 

approval 

• Assists with the annual election of NOSB officers

• Monitors and notifies Subcommittee Chairs periodically of public comments posted 

to the open docket between the period when the meeting notice is posted in the 

Federal Register and when the proposals are posted.

• May delegate tasks to others, but retains responsibility for the official record 

ADMINISTRATIVE TEAM 

The Administrative Team consists of the Chair, Vice Chair, Secretary, and Designated 

Federal Official/Advisory Committee Specialist. . This group is responsible for 

coordinating logistics and operations of the Board. The Administrative team meets via 

teleconference on an as-needed basis, to be determined by the Administrative Team. 

This team is not a subcommittee and makes no decisions. All items needing further 

discussion or action are placed on the Executive Subcommittee agenda and are 

recorded in the Executive Subcommittee notes.

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E. NOSB-NOP COLLABORATION 

In 1990, the Organic Foods Production Act (OFPA: 7 U.S.C. 6518 (a)) directed the Secretary of 

Agriculture to “establish a National Organic Standards Board (in accordance with the Federal 

Advisory Committee Act (FACA)) ... 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 the Act. Section 6503 (a) of the OFPA requires that the Secretary “shall

establish an organic certification program ... and shall consult with the NOSB” (6503(c)). The 

National Organic Program (NOP) is the governmental institution responsible for implementing 

the OFPA and is the means through which the NOSB provides advice and assistance to the 

Secretary of Agriculture. The NOSB, as a FACA advisory committee, must conduct business in the 

open, under the requirements of P.L. 94-409, also known as “Government in the Sunshine Act” (5 

U.S.C.552b). 

The USDA cannot delegate its authority as a regulatory body to private citizens, even when those 

private citizens are appointed by the Secretary to provide advice. Therefore, the NOSB cannot 

direct USDA or bind the Secretary through its actions; for example, it cannot obligate funds, 

contract, make NOP staffing decisions, or initiate policies of its own accord

However, the NOSB has unique statutory authority related to the recommendation of materials 

as approved or prohibited substances for inclusion on the National List. 

The unique nature of the NOSB and its relationship with the NOP, as established through OFPA, 

requires that the volunteer Board, which regularly receives stakeholder input through public 

comment, must work collaboratively with the NOP.

Similarly the NOP, as required through OFPA, must consult and collaborate with the NOSB

Team work and collaboration between the NOSB and the NOP, as well as others in the organic 

community, is needed to maintain, enhance and promote the integrity of organic principles and 

products. Successful collaboration is dependent on effective communication and constructive 

feedback. Communication is facilitated by the Advisory Committee Specialist, who participates in 

all NOSB calls. Additionally, the NOP Deputy Administrator or designee will participate in all ES 

calls, and in other standing Subcommittee calls upon request and mutual agreement. In addition, 

each standing Subcommittee will be assigned an NOP staff person to provide technical, legal, and 

logistical support.

The work of the NOP and NOSB since the 1990 passage of the OFPA clearly demonstrates the 

need for the high level of collaboration and consultation described above. NOP, NOSB and its 

associated stakeholders must continuously work to seek common ground, collaborate and 

consult in order to build organics and maintain organic integrity. Every aspect of this work must 

take place in a manner which clearly demonstrates mutual respect and positive intent. 

F. NOSB WORK AGENDAS

The NOSB Work agenda is a list of projects for the upcoming semester or year for each of the 

Subcommittees. Agendas are developed via collaboration between the NOSB and the NOP and 

are revised based on AMS-NOP requests, NOSB priorities, and public comment. 

Work agendas are developed based on the following criteria: 

NOSB October 2019 proposals and discussion documents Page 158 of 230
• Within Scope: Item must be within the scope of OFPA. NOP must have a clear sense of the 

intent and scope of the work agenda item. The public may petition additions or deletions 

from the National List that will be added to the work agenda. In addition, the public may 

submit comments to the NOSB or write to the NOP for potential additions to the work 

agenda. For the NOSB, work agenda items may emerge from discussions on current issues.

• USDA and NOP Priority: Item must be a priority for the USDA/NOP; something that the NOP 

is able to implement in a reasonable timeframe. 

• Clear Need: Item must reflect a clear need for the NOP and/or organic community, for 

which new or additional information or advice is needed. 

The NOSB work agenda establishes Subcommittee work for the upcoming semester or year, and 

is developed through the following process: 

1. NOSB Subcommittees submit to the Executive Subcommittee draft work agenda items 

based on AMS-NOP requests, NOSB priorities, and requests from public comment. 

2. The NOP and Executive Subcommittee review the draft NOSB work agenda. The content and 

schedule will be reviewed on an ongoing, as needed basis. 

3. NOP confirms the final NOSB work agenda, and provides written confirmation. 

Work agenda items should be prioritized accordingly:

1. Substance evaluations (e.g., 5-year sunset review, petitions) 

2. NOP requests to the NOSB 

3. NOSB requests to NOP

4. Other projects

Below are descriptions of common NOSB work agenda items and the corresponding NOP and NOSB 

responsibilities. 

• Review of materials proposed to be added to or removed from the National List

The NOSB has the statutory authority to consider and recommend materials for addition to, 

or deletion from, the National List of Approved and Prohibited Substances. The NOSB may 

also make recommendations to add, remove, or modify annotations restricting the use of 

such listed materials.

• Changes to annotation or classification of materials

The NOSB may request to review an existing substance on the National List without a new 

petition when they have justification to support a revision of the annotation or 

reclassification of the substance. This may happen as a result of the sunset review process, 

or as new information is provided in a Technical Review, or from public comment. 

• Recommendation for modification of existing standards or new standards 

The NOP may request that the NOSB develop recommendations for new or existing 

standards. The request should be in writing and include a statement of the problem to be 

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addressed, background, including the current policy or situation, statutory/regulatory 

authority, legal context, and desired timeframe for receiving the recommendation. The 

request will be posted on the NOP web site.

• Advice on NOP policy and interpretation of standards

The NOSB may provide comments on guidance or policy memos included in the Program 

Handbook, or may also make recommendations for new guidance or policies.

• Compliance and Enforcement 

The NOP is responsible for compliance and enforcement. The NOP welcomes NOSB input on 

standards, but NOSB involvement in active investigations or enforcement actions is not 

appropriate. When timely and appropriate, the NOP reports to the NOSB the status of 

enforcement actions and also posts the status on the NOP web site.

• Management Review

The NOSB may review the quality management system and internal audits to ensure that 

the NOP is managed effectively and efficiently. For example, the NOSB may be asked for 

informal feedback or to work on specific work agenda items that relate to the development 

or implementation of audit corrective actions. 

G. Designated Federal Officer 

FACA and its implementing regulations (5 U.S.C. App. 2) govern the roles and responsibilities of 

NOSB management including meeting coordination and facilitation. The Designated Federal 

Officer (DFO) is the individual designated to implement advisory committee procedures. The 

AMS/NOP Deputy Administrator is the DFO for the NOSB. 

The NOP Deputy Administrator or designee acts as the Designated Federal Officer (DFO) during 

public meetings of the NOSB and meetings of the Executive Subcommittee. The Advisory 

Committee Specialist (ACS) or designee acts as the DFO for all other NOSB Subcommittee 

meetings. The DFO holds the authority to chair meetings when directed to do so by the official 

to whom the advisory committee reports. 

The DFO’s duties include but are not limited to: 

• Approving and calling the meeting of the NOSB

• Approving the semi-annual meeting agenda

• Attending the semi-annual meetings

• Adjourning the meetings when such adjournment is in the public interest

H. Advisory Committee Specialist 

The Advisory Committee Specialist (ACS) is an NOP staff member who is assigned to support the 

NOSB. The Advisory Committee Specialist prepares the Advisory Committee’s and 

Subcommittees’ meeting agendas and notes, and attends all meetings. The position of Advisory 

Committee Specialist (formerly called Executive Director) was added in 2005 to facilitate 

communication and collaboration between the NOP and the NOSB. Advisory Committee 

Specialist duties include but are not limited to:

NOSB October 2019 proposals and discussion documents Page 160 of 230
• Ensuring that all FACA and OFPA requirements are implemented 

• Managing calendars and work agendas to facilitate Subcommittee and NOSB activities

• Arranging, facilitating, and documenting the NOSB Subcommittee conference calls

• Ensuring NOSB members have all necessary materials and information to provide informed, 

structured and timely recommendations to the NOP 

• Conducting meeting planning activities for the semi-annual NOSB meetings, including 

preparation of Federal Register notices and press releases, and facilitation of public 

comments 

• Coordinating the NOSB nomination and chartering process

• Facilitating training of NOSB members

• Managing information reporting and communication between the NOSB and NOP

I. ADDITIONAL ADMINISTRATIVE ITEMS 

• Official to whom the Committee Reports

The NOSB shall provide recommendations to the USDA Secretary through the Designated 

Federal Officer, the Agricultural Marketing Service’s NOP Deputy Administrator.

• Staff Support

The NOP shall provide administrative support to the NOSB through the work of an Advisory 

Committee Specialist, who is a permanent NOP staff member. The NOP may also provide 

technical support to the NOSB based on need and available resources. 

• Estimated Number and Frequency of Meetings

The NOSB meets approximately twice per year for public meetings. Most NOSB 

Subcommittees meet approximately twice a month by conference call. 

• Recordkeeping

Records of the NOSB shall be defined and handled in accordance with General Records 

Schedule 6.2 or other approved agency records disposition schedule. . This schedule is 

available online at: https://www.archives.gov/records-mgmt/grs/grs06-2.pdf. These records 

shall be available for public inspection and copying, subject to the Freedom of Information 

Act, 5 U.S.C. 552. Requests for records should be handled in accordance with the GSA 

March 14, 2000 memo that is available online here: 

http://www.gsa.gov/portal/content/100785. Information about the NOSB is available 

online at: 

http://www.ams.usda.gov/rules-regulations/organic/nosb

While meeting transcripts are not required under FACA, the NOP provides transcripts or 

meeting notes to support the transparency of NOSB meetings and to support subsequent 

rulemaking activities. Minutes of each NOSB meeting, as approved by the DFO and the 

NOSB Chair and Secretary, shall contain a record of the persons present, documents 

provided to the board, a complete and accurate description of matters discussed and 

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conclusions, and the outcome of voting. If not included in the minutes, a voting summary 

will be published that contains votes by member. 

FACA requires (5 U.S.C. App. Section 10 (b) ): “Subject to section 552 of title 5, United States 

Code, the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, 

agenda, or other documents which were made available to or prepared for or by each 

advisory committee shall be available for public inspection and copying at a single location 

in the offices of the advisory committee or the agency to which the advisory committee 

reports until the advisory committee ceases to exist.” 

Any request for FACA records must be made to the NOP.

While requests for FACA Board records do not have to go through the formal FOIA request 

process, those records must be reviewed by AMS/NOP before release, to determine 

whether any FOIA exemptions apply (e.g., personal information, business proprietary 

information). In addition, OFPA itself requires that no confidential business information be 

released, so emails and documents need to be reviewed before release to ensure that this 

requirement is met. 

• Freedom of Information Act (FOIA; 5 U.S.C. 552). Under this Act, the public may request 

documents and other information pertaining to USDA actions. NOSB communications with 

USDA (including email) are subject to these requests, with limited exemptions. Some USDA 

information is routinely exempt from disclosure in or otherwise protected from disclosure 

by statute, Executive Order or regulation; is designated as confidential by the agency or 

program; or has not actually been disseminated to the general public and is not authorized 

to be made available to the public upon request. When there is a FOIA request for 

information, the USDA will review all relevant information and determine what qualifies for 

release, then provide it to the requestor. 

J. PROFESSIONAL AND ETHICAL STANDARDS 

As appointees of the Secretary, NOSB members must maintain high professional and 

ethical standards both within and outside of the NOSB. Areas of particular concern 

include professional conduct and conflict of interest. 

1) NOSB Member Professional Conduct Standards

NOSB members shall:

• Observe ethical principles above private gain in the service of public trust. 

• Put forth an honest effort in the performance of their NOSB duties. 

• Make no commitments or promises of any kind purporting to bind the Government. 

• Act impartially and not give preferential treatment to any organization or individual. 

• Participate in meetings – Subcommittee conference calls as well as semi-annual 

meetings 

• Serve on Subcommittees as assigned - Each member must be willing to serve on 

Subcommittees as assigned by the NOSB Chair, and to participate in the work of 

those Subcommittees. 

• Be informed about NOSB business - NOSB members are expected to seek and study 

the information needed to make reasoned decisions and/or recommendations on all 

business brought before the NOSB. 

NOSB October 2019 proposals and discussion documents Page 162 of 230
To maintain the highest levels of honesty, integrity, and ethical conduct, no NOSB 

member shall participate in any “specific party matters” (i.e., matters that are narrowly 

focused and typically involve specific transactions between identified parties) such as a 

lease, license, permit, contract, claim, grant, agreement, or related litigation with the 

Department in which the member has a direct or indirect financial interest. This includes 

the requirement for NOSB members to immediately disclose to the NOP’s Advisory 

Board Specialist any specific party matter in which the member’s immediate family, 

relatives, business partners, or employer would be directly seeking to financially benefit 

from the Board’s recommendations. 

 

All members receive ethics training annually to identify and avoid any actions that

would cause the public to question the integrity of the NOSB’s advice and 

recommendations. The provisions of these paragraphs are not meant to exhaustively 

cover all Federal ethics laws and do not affect any other statutory or regulatory 

obligations to which advisory committee members are subject.

2) Additional Standards of Conduct

NOSB members should adhere to the following basic “standards of conduct” while in

government service: 

• Do not accept improper gifts (from those seeking actions from the Board). 

• Do not use board appointments for private gain. 

• Do not misuse internal non-public government information. 

• Do not use government property and time improperly. 

• Do not accept compensation for teaching, speaking, and writing related to your 

board duties. 

• Do not engage in partisan political activities while performing your board duties or 

while in a federal building.

• Alert the NOSB designated federal officer (DFO) if you or your employer enters into 

a lawsuit against USDA or its sub-agencies.

• Refrain from sharing working documents with the public. Working documents are 

defined as information that a board member gains by reason of participation in the 

NOSB and that he/she knows, or reasonably should know, has not been made 

available to the general public: e.g. is not on the NOP or other public websites, or is 

a draft document under development by an NOSB Subcommittee.

• Do not circulate draft Subcommittee documents until they are finalized and publicly 

available to all on the AMS/NOP website. 

• Use a professional, respectful tone in NOSB email correspondence; remember that 

all correspondence with government officials is subject to FOIA requests.

• To the maximum extent possible, NOSB members should speak with one voice. 

Although there may be disagreements within NOSB Subcommittees or working 

group sessions, once NOSB members leave the session, they have the responsibility 

to support the integrity of the process, whether or not they agree with the final 

outcome. While NOSB members retain the right to express minority opinions, the 

public airing of dissension could strain interpersonal relationships and create 

distrust and conflict among NOSB members. Such stresses could undermine the 

NOSB’s ability to effectively carry out its role as a governmental advisory board. 

3) Failure to participate 

The NOSB typically has a heavy work load and thus active participation by all 15 

NOSB October 2019 proposals and discussion documents Page 163 of 230
members is essential to carry out the mandates in OFPA. When one or more members 

fail to actively participate in Board work the entire NOSB and the organic community is 

negatively impacted. If a Board member finds that s/he cannot consistently attend 

Subcommittee meetings, take on work assignments, complete Subcommittee work in a 

timely manner, or cannot attend the twice-yearly public meetings and public comment 

listening sessions, the NOSB Chair shall discuss the matter with the Board member, 

bring the concerns to the attention of the Executive Subcommittee, and if necessary,

encourage the Board member to resign.

K. DECLARATION OF INTERESTS/Conflict of Interest

NOSB members are classified as representatives under the Federal Advisory Committee Act 

(FACA). Each representative is appointed to articulate the viewpoints and interests of a 

particular interest group. The Organic Foods Production Act (OFPA) prescribes these interest 

groups, which include farmers/growers, handlers, certifiers, environmentalists/conservationists, 

scientists, consumers and public interest groups, and retailers. Representatives are appointed to 

speak in “we” terms, serving as the voice of the group represented (e.g., “we farmers/growers 

believe...”). As such, NOSB members are not expected to provide independent expert advice, 

but rather advice based on the interests of the groups served. 

 

NOSB members represent the interests of a particular group. As such, many of the interests are 

acceptable interests. An interest is acceptable if it is carried out on behalf of a represented 

group, and if a Board member receives no disproportionate benefit from expressing the interest. 

True conflicts of interest arise when an interest: 

• Directly and disproportionally benefits you or a person associated with that member; 

• Could impair your objectivity in representing your group; or 

• Has the potential to create an unfair competitive advantage. 

The appearance of a personal conflict and loss of impartiality, while not a true conflict, must be 

considered when conducting NOSB business. 

Declarations of Interest/Conflicts of Interest Procedures 

Board members are appointed in part because of their interests. As such, each NOSB member

needs to actively consider their interests with respect to topics being considered by the Board, 

and identify whether these interests would create appearance problems. This consideration 

should occur at two specific points during the Board’s work on a particular topic. The first 

consideration should occur at the Subcommittee level, when a Subcommittee begins work on 

material or topic. The second is when a discussion document or proposal advances from the 

Subcommittee to the full Board for consideration. 

At the Subcommittee Level

NOSB members represent the diverse interests of a broad stakeholder community, and make 

recommendations that may have wide-reaching regulatory impacts across all of these interest 

groups. As such, NOSB member actions are carefully scrutinized. 

Given this, the NOP has provided the following guidelines for NOSB members working at the 

Subcommittee level: 

NOSB October 2019 proposals and discussion documents Page 164 of 230
• Avoid leading projects for which you could reasonably be viewed by others as having a particular 

interest that would hinder your ability to objectively and fairly represent broader group 

interests, and to allow other members to represent theirs. If leading a project would likely lead 

others to believe you are “self-dealing” to benefit yourself or someone close to you, you should 

refrain from leading. 

• If you feel you may have an appearance problem or conflict of interest, you should inform the 

DFO that a conflict may exist, and describe the nature of that conflict. You should also tell the 

Subcommittee impacted that you may have a conflict; sharing as much or as little about the 

nature of the conflict with other board members as you wish. After this declaration, you may 

continue to contribute to the discussion on the topic. As long as it is known there is a conflict of 

interest, the conflict does not preclude the member from contributing his or her input to the 

Subcommittee. 

• If you are uncertain as to whether an interest constitutes an appearance problem or a true 

conflict, then contact the DFO to discuss it. In this case, the NOP, working with the USDA office 

of ethics as needed, will make the determination about whether a problem exists.

At the Full Board Level

Once discussion documents and proposals are posted for public comment, each NOSB member is to 

review the documents across all Subcommittees, and research any potential conflicts of interest due 

to organizational affiliation or relationships. 

The following procedures will take place at the Board level: 

1. Approximately 2-4 weeks before the meeting, the NOP’s DFO will provide a matrix to all 

NOSB members that lists the items being considered at the meeting. 

2. If you determine that you do have a conflict of interest, use the matrix to disclose that 

information and to declare a recusal from voting on the item(s). 

3. If you are not sure whether an interest is acceptable or poses a problem, or if you are 

uncertain whether recusal is needed, contact the NOP DFO to discuss. The NOP, working 

with the USDA office of ethics as needed, will make the determination about whether a 

conflict of interest exists, and will instruct the member accordingly as to whether to vote or 

not. 

4. Return your completed matrix approximately one week before the board meeting. The NOP

will then use these to compile a list of all recusals for the meeting. 

5. At the meeting, at the beginning of each subcommittee session or at a time designated at 

the discretion of the Board chair, the DFO will state: “the following Board members have a 

conflict of interest with the following documents, and will not be voting: e.g. Bob has a 

conflict and will recuse himself from the proposals CleanGreenA and GreatChemB (etc.).” 

NOSB October 2019 proposals and discussion documents Page 165 of 230
6. Once the DFO completes listing the recusals, the NOSB Subcommittee chair leading the 

session may invite additional information from members on a voluntary basis, with a 

statement such as: “if Board members wish to disclose information about their conflict, or 

any other information about their interests, they are welcome to do so at this time.” this is 

to be stated as a general and voluntary invitation; no specific NOSB member is to be called 

on. 

7. For any documents deferred to the last day of the meeting, the DFO will repeat the 

declaration of statement above at the start of the voting session for each subcommittee. 

When it is time to vote, the NOSB member recusing her/his self should state “recuse” when 

it is his or her time to vote. 

IV. SUBCOMMITTEES 

Subcommittees play an important role in administering the NOSB’s responsibilities to make 

informed decisions. The Subcommittees are responsible for conducting research and analyses, 

and drafting proposals for consideration by the full NOSB. No Subcommittees are authorized to 

act in place of the NOSB. Subcommittees are either standing or ad hoc. 

A. STANDING SUBCOMMITTEES 

The current standing Subcommittees are: 

• Executive (ES)

• Certification, Accreditation, and Compliance (CACS)

• Crops (CS)

• Handling (HS)

• Livestock (including Aquaculture) (LS)

• Materials (including GMOs) (MS)

• Policy Development (PDS)

Executive Subcommittee (ES)

The Executive Subcommittee of the NOSB shall be comprised of the Chair, Vice Chair, 

Secretary, and the Chairs of each of the standing Subcommittees. The Executive 

Subcommittee provides overall coordination for the NOSB including finalizing the NOSB 

meeting agenda and NOSB work agendas. 

Certification, Accreditation, and Compliance Subcommittee (CACS) 

The CACS drafts proposals for consideration by the NOSB to provide guidance, clarification, 

or proposed standards for the certification, accreditation and compliance sections of the 

USDA organic regulations and OFPA.

 

Crops Subcommittee (CS)

The CS drafts proposals for consideration by the NOSB to provide guidance, clarification, or 

proposed standards for the crop production sections of the USDA organic regulations and 

OFPA. The CS reviews substances under sunset review and petitions for addition to, or 

removal from the National List of Allowed and Prohibited Substances. The CS reviews

technical reports (TRs), technical advisory panel reports (TAPs), and public comments 

concerning materials used for organic crop production to draft their proposals.

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Handling Subcommittee (HS) 

The Handling Subcommittee drafts proposals for consideration by the NOSB to provide 

guidance, clarification, or proposed standards for the handling and labeling sections of the 

USDA organic regulations and OFPA. The HS reviews substances under sunset review and 

petitions for addition to or removal from the National List of Allowed and Prohibited 

Substances. The HS reviews technical reports (TRs), technical advisory panel reports (TAPs), 

and public comments concerning materials used for organic handling to draft their 

proposals. 

Livestock Subcommittee (including Aquaculture) (LS) 

The LS drafts proposals for consideration by the NOSB to provide guidance, clarification, or 

proposed standards for the livestock and livestock feed sections of the USDA organic 

regulations and OFPA. The LS reviews substances under sunset review and petitions for 

addition to or removal from the National List of Allowed and Prohibited Substances. The LS 

reviews technical reports (TRs), technical advisory panel reports (TAPs), and public 

comments concerning materials used for organic livestock and aquaculture production to 

draft their proposals.

 

Materials Subcommittee (including Genetically Modified Organisms) (MS)

The MS drafts proposals for consideration by the NOSB to provide guidance, clarification, 

or proposed standards for the pertinent National List sections of the USDA organic 

regulations and OFPA. The MS works with the NOP and other NOSB Subcommittees in 

managing the Materials Review Process, which may include determining which 

Subcommittee will conduct a review, as well as tracking technical reports and the status of 

reviews for petitions and sunset materials. The MS also drafts proposals and discussion 

documents regarding the prohibition on the use of Genetically Modified Organisms 

(excluded methods) under the USDA organic regulations. Research Priorities are also a 

critical component of the annual work agenda of the MS.

In addition to a Chair, who will be appointed by the NOSB Chair, the MS shall include in its 

membership a representative from each of the Livestock, Crops, and Handling 

Subcommittees. 

Policy Development Subcommittee (PDS) 

The Policy Development Subcommittee provides clarification and proposed changes for 

NOSB internal policies, and procedures as needed, in collaboration with the NOP. The PDS, 

in collaboration with the NOP, also updates and revises the NOSB Policy and Procedures 

Manual and the Member Guide. 

B. AD HOC SUBCOMMITTEES

At the discretion of the NOSB Chair, and with approval of the Executive Subcommittee and 

the DFO, ad hoc NOSB Subcommittees may be formed to develop policy and guidance on 

specific issues that involve multiple standing Subcommittee jurisdictions, or for issues or 

tasks that are very large and require additional resources to complete. Ad hoc 

Subcommittees must be comprised of current NOSB members, and may be either a 

combination of two or more standing Subcommittees to form a “joint” Subcommittee, or 

may be a completely new Subcommittee comprised of selected NOSB members from 

various standing Subcommittees. Ad hoc Subcommittees can be dissolved at the 

recommendation of the NOSB chairperson with the approval of the Executive 

Subcommittee. Ad hoc Subcommittee Chairpersons are non-voting members of the 

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Executive Committee.

C. SUBCOMMITTEE MEETINGS 

Subcommittees generally hold meetings once or twice a month via telephone 

conference calls. Calls are scheduled well in advance on a regular reoccurring interval. 

Additional meetings can be held if a Subcommittee requests additional time and the 

NOP agrees to provide the resources to support the additional meeting. A majority of 

the members of a Subcommittee shall constitute a quorum for the purpose of 

conducting Subcommittee business. 

D. TASK FORCES 

The NOSB may request the establishment of a Task Force to explore specific issues or 

concerns relevant to the organic community and industry, and present to the NOSB

draft proposals, discussion documents, or reports. Each task force shall:

• Have a specific work agenda approved by the NOP 

• Have a clearly articulated project deliverable 

• Include at least one current member of the NOSB

• Record and maintain meeting or conference call minutes, made available to the 

NOSB and the NOP 

• Submit a final report to the NOSB

• Disband when the NOP notifies the Task Force that its work has concluded or when 

the task force is no longer necessary. 

• Have a specific start and end date, which may be extended by the Executive 

Subcommittee, with concurrence by NOP. 

E. DUTIES OF SUBCOMMITTEE CHAIRS AND VICE CHAIRS

Subcommittee Chair duties:

• Appoint a Subcommittee Vice Chair in consultation with Board Chair

• Consult with the Board Chair regarding Subcommittee appointments

• Schedule Subcommittee meetings as needed 

• Draft Subcommittee meeting agendas and work agendas in consultation with 

Subcommittee members, the Executive Committee, and NOP staff 

• Convene and preside over Subcommittee meetings 

• Ensure Subcommittee meeting notes are recorded

• Ensure that Subcommittee meeting notes are reviewed for accuracy 

• Report actions of the Subcommittee to the Executive Subcommittee and Board 

• Serve as mentor/trainer for new Subcommittee Chair during transition periods

• Designate a liaison to the Materials Subcommittee to collect, compile and present 

the research priorities proposals. 

Subcommittee Vice Chair duties: 

• Provide support in developing and completing Subcommittee work agendas

• Assist in reviewing Subcommittee meeting notes for accuracy

• Represent the Chair in the event of the Chair’s absence

• The Vice Chairs of the Crops, Livestock and Handling Subcommittees will serve on 

the Materials Subcommittee as liaisons for reviewing all petitioned substances.

NOSB October 2019 proposals and discussion documents Page 168 of 230
F. TRANSITION OF SUBCOMMITTEE CHAIRS, VICE CHAIRS, AND MEMBERS (NEW AND 

CONTINUING)

Subcommittee Chairs shall be appointed to serve annually by the Chair of the Board. 

Vice Chairs and Subcommittee members shall be appointed by their respective 

Subcommittee Chair in conjunction with the NOSB Chair. The annual Subcommittee 

term shall be concurrent with the one-year term established by the Secretary (beginning 

on January 24 and ending the following January 23). Newly appointed Chairs, Vice Chairs 

and Subcommittee members will assume their positions at the beginning of the new 

term, after a period of orientation and mentorship provided by the outgoing Chair, Vice 

Chair, and members.

To avoid disruption in the quality and volume of work produced by the NOSB, the 

following procedures will be observed: 

After the election of NOSB Officers at the Fall Meeting:

1. The new NOSB Chair takes Office 

At the close of the meeting at which the election occurred, the newly elected Chair 

takes office. 

2. Appointment of Subcommittee Chairs 

The Board Chair appoints Subcommittee Chairs preferably chosen from members 

with at least one year of NOSB experience.

3. Appointment of Subcommittee Vice Chair

Vice Chairs shall be appointed by the incoming Subcommittee Chair, in conjunction 

with the Board Chair. 

Timeframe for Appointments 

Subcommittee Chairs shall be appointed by the NOSB Chair and seated within a 

reasonable time after the newly elected NOSB Chair takes office (or continues in 

office), and Vice Chairs shall be appointed by Subcommittee Chairs as soon as 

possible after that. 

4. Review of Subcommittee Files 

New Subcommittee Chairs should review all work agenda items and active files 

involving Subcommittee work 

Mentorship Period 

The incoming Chair and Vice Chair of each Subcommittee shall participate in an 

orientation and mentorship period with the outgoing Chair and Vice Chair of their 

Subcommittee until seated in their positions at the beginning of the new term on 

January 24. The Board Chair, to facilitate an effective transition for new members of 

the Board and ensure effective participation in Committee and Board deliberations, 

shall ask incoming Board members to identify a mentor from existing Board 

members, or, if the Board member prefers, the Board Chair shall assign a mentor. 

5. Appointment of New NOSB Members: 

The Board Chair will appoint each new NOSB member to appropriate 

Subcommittees as soon as possible, so that on January 24 all Subcommittees are in 

place. The NOSB Chair will consult with outgoing and incoming Subcommittee Chairs 

and other Board officers, with due consideration of the members interest, expertise, 

NOSB October 2019 proposals and discussion documents Page 169 of 230
and background, as well as the composition and needs of the new Board and scope 

of Subcommittee work agendas. Once appointed, incoming Subcommittee members 

shall be included in all email communication pertaining to the Subcommittees on 

which they serve.

Changing Subcommittee Appointments

Board members who would like to join or leave a Subcommittee shall submit a request 

to the Board Chair. If the request does not alter the preferred number of Subcommittee 

members, in the range of five to seven, the expectation is that the request will be 

approved, unless the Board Chair finds that such a change will interfere with the 

functioning of the Subcommittee or the Board. The Chair’s determination should be 

made in consultation with Subcommittee Chairs and the Executive Subcommittee.

Filling a Subcommittee Chair and/or Vice Chair vacancy

If a Subcommittee Chair position becomes vacant, the Subcommittee Vice Chair shall 

assume the position as Chair and the new Subcommittee Chair shall appoint a new Vice 

Chair in accordance with the consultation procedures cited above.

G. PROCEDURES FOR COMPLETING SUBCOMMITTEE PROPOSALS AND DISCUSSION 

DOCUMENTS

1. Development of proposals

Each of the NOSB Subcommittees will develop proposals, discussion documents or 

reports based on the current work agenda. 

 

• A Subcommittee drafts a proposal or discussion document based on that 

Subcommittee’s work agenda. 

• By a simple majority, the Subcommittee can vote to pass a proposal or discussion 

document to the full Board for consideration at a subsequent NOSB meeting. In 

order to be considered for a vote during an NOSB meeting, all proposals must be 

voted on by the Subcommittee and submitted to the NOP at least forty-five (45) 

days prior to a scheduled NOSB meeting.

• When it is not possible for a Subcommittee, during its regular deliberations on 

conference calls, to reach consensus on a proposed document/recommendation as 

it is being reviewed, and there are substantive irreconcilable differences, a minority 

of the Subcommittee may develop a written minority view for review by all 

members of the Subcommittee. The Subcommittee Chair has the responsibility to 

facilitate the process for the minority view.

A minority view should: 

o Be short and concise, and include reasons for opposing the Subcommittees 

recommendation; 

o Should not include any data or information not introduced on a 

Subcommittee call; 

o Should be submitted in a timely manner, and will not be accepted after the 

Subcommittee has voted on its recommendation; 

o Will be included as a separate section at the end of the recommendation.

• The NOP will post the proposal or discussion document for public comment. 

• At any point in the process prior to the Board’s vote, a Subcommittee may convene 

and, by a simple majority, vote to withdraw its proposal from consideration by the 

Board. 

NOSB October 2019 proposals and discussion documents Page 170 of 230
• During a subsequent Board meeting, the Subcommittee presents the proposals and 

discussion documents as well as a summary of public comments and other relevant 

information for discussion and consideration by the full Board.

2. Types of Proposals 

 (See Member Guide for examples)

There are several formats for writing proposals and discussion documents, based on 

the subject under review:

o Proposals related to material petitions, sunset reviews, annotation changes, or 

classification changes. 

o Proposals for policy or procedure changes 

o Discussion documents

o Petitioned material discussion documents

3. Presenting Subcommittee Proposals and Discussion Documents at NOSB Meetings

NOSB Subcommittees and task forces should follow the outline below when presenting

proposals or discussion documents for consideration by the Board: 

1. Introduction: A brief summary of the issue or statement of the problem. 

2. Background: An explanation with sufficient detail and rationale to support 

the proposal, including reasons why the proposal should be adopted, 

historical context, and the regulatory framework pertinent to the issue. 

3. Proposal: A concise explanation of the recommended action. 

4. Subcommittee Vote: The Subcommittee vote shall be reported. In the case 

of petitions to add materials to the National List, two votes will be reported; 

one for classification of the material as a synthetic or non-synthetic, and the 

other a motion to list. 

5. Public Comment: A brief summary of the public comments

6. Minority View: If applicable, the minority view of a Subcommittee or task 

force member shall be reported. After the Subcommittee's proposal has 

been presented and the motion to adopt has been made, it is usual to allow 

the minority to present their views. The minority report is presented for 

information purposes only. If the Board then determines that the minority 

view has merit, it may send the proposal back to Subcommittee for further 

work, since it would be a substantive change to the proposal as presented. 

H. SUBSTANCE/MATERIALS REVIEW PROCESS

A primary function of the NOSB is “to assist in the development of standards for substances 

to be used in organic production” (OFPA 6518 (a)). “The Board shall develop the proposed 

National List or proposed amendments to the National List for submission to the Secretary 

...” (OFPA 6518(k)). The OFPA also establishes a petition process by which the public can 

request additions or deletions to the National List and also provides for a 5 –year “sunset” 

review by NOSB of all substances on the National List. The Materials Review Process is a 

collaborative effort between the NOP and NOSB. Some phases of the review process are 

handled exclusively by NOP and some by the NOSB.

The petition process is open to all. Petitions must be filed in accordance with the most 

recent Federal Register notice instructions and NOP 3011, Procedure- National List Petition 

Guidelines, effective March 11, 2016.

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In lieu of a formal petition, a Subcommittee (Livestock, Crops, Handling) of the NOSB may 

propose to remove a material from the National List by developing a proposal for 

consideration by the whole Board, provided that all criteria in OFPA at Section 6518(m) are 

documented as having been addressed in the proposal. Procedures for such a petition will 

be the same as for changes to annotations or classification of materials, as amended at H2 in 

this PPM.

Steps in the material review process for a new petition: 

1. NOP receives a petition, reviews it for completeness and eligibility according to OFPA

and the petition guidelines. NOP forwards the petition to the appropriate Subcommittee 

with a courtesy copy to the Materials Subcommittee.

2. Subcommittee (SC) determines sufficiency of the petition. If found insufficient, the 

subcommittee will notify the NOP of additional questions or information, and NOP will 

send that feedback to the petitioner. 

3. Subcommittee (SC) determines if a technical review (TR) is needed. 

4. SC may develop a discussion document based on the petition and forward that 

document to the full board for posting, and to solicit public discussion.

5. Technical report is completed and sent to the subcommittee for review. 

6. TR sufficiency is determined by SC, and the TR is posted on the NOSB website by the 

NOP. 

7. SC reviews substance, develops proposal, discusses proposal and votes, and submits for 

posting ~45 days prior to public meeting.

8. The NOSB members analyze comments and vote on the proposal at the public meeting. 

9. The NOSB chair delivers the final recommendations to NOP. 

Step 1: Receipt of Petition 

During this phase the NOP will: 

• Notify the petitioner via letter and/or electronic mail of receipt of the petition. 

• Determine whether the petition is complete and whether the petitioned substance 

is eligible for petition under the Organic Foods Production Act and its implementing 

regulations, and whether subject to other agency authority (e.g. EPA, FDA); 

• NOP documents this review using two checklists.

o OFPA Checklist, NOP 3005-1 

o Petition Checklist, NOP 3005-2 

Ineligible petitions include: 

• Formulated (brand name) products

• Food additive without FDA approval

• Pesticide without EPA tolerance or tolerance exemption

• Requests to add substances already allowed

• Synthetic macronutrient (e.g., NPK) fertilizers

NOSB October 2019 proposals and discussion documents Page 172 of 230
• Materials otherwise prohibited by the USDA organic regulations (e.g., 

sewage sludge, GMOs, etc.)

• Previously petitioned/rejected materials (if no new information is provided)

Upon determination of completeness and eligibility, NOP will: 

• Notify the petitioner, via letter and/or electronic mail, that the petition is 

complete and eligible; 

• Publish the petition on NOP website; and 

• Notify the NOSB Subcommittee that the substance is being petitioned for 

addition or prohibition from the National List and provide the OFPA and petition 

checklists.

• NOP is the primary point of contact for any correspondence between NOSB and 

petitioner

Step 2: Subcommittee (SC) determines sufficiency of the petition

During this phase, the applicable NOSB Subcommittee has 60 days to review the 

petition and determine if the petition is sufficient for SC review. This decision may be 

based on the following:

• Is there sufficient information in the petition for the SC to determine why or 

for what purpose the material is being petitioned?

• what is the petitioners proposed wording for listing the material?

• Is the information presented in the petition clear and consistent so that a 

proposal may easily be developed?

 If the petition is found insufficient, the Subcommittee will notify the NOP of additional 

 questions or information, and NOP will send that feedback to the petitioner.

Step 3: Subcommittee determines whether a Third-Party Technical Review is required 

During this phase, which may occur simultaneously with the determination of petition 

sufficiency, the applicable NOSB Subcommittee has 60 days to review the petition and 

determine whether a third-party technical review is required. This decision is based on 

the following:

• Is there sufficient information in the petition that makes a technical review 

unnecessary?

• Do any previous technical reviews of other materials provide sufficient 

information?

• Can the Subcommittee reasonably research any needed technical information?

• Can sufficient information be obtained from public comment? 

• Does the Subcommittee have the expertise needed to address the questions 

related to the petition? This includes impact on the environment, impact on 

human health, and sustainability and compatibility with organic principles. 

If the Subcommittee decides a Technical Review is needed, the Subcommittee Chair will 

make the request to the National List Manager. The SC may also submit questions for 

NOSB October 2019 proposals and discussion documents Page 173 of 230
specific information based on the OFPA evaluation criteria (7 USC 6817(m)), or suggest 

recommended technical expertise. The NOSB may request more information from the 

petitioner if needed. 

If the Subcommittee decides the Technical Review is not needed, the Subcommittee 

Chair will inform the National List Manager. 

In some cases, the Subcommittee may decide the substance is ineligible for the National 

List without need for a Technical Review. In this case, they will develop a proposal to 

reject the substance at the next NOSB meeting, subject to a full board vote. 

A limited scope or supplemental TR may be appropriate when the petition is to amend 

an existing listing, remove a listing, or for purposes of sunset review. 

Option for a Technical Advisory Panel (TAP)

OFPA states: “The NOSB shall convene technical advisory panels to provide scientific 

evaluation of materials considered for the National List.”(7 USC 6518 (k)(3))

The NOSB has not convened independent Technical Advisory Panels since 2005. 

Currently the NOSB is relying on information within the Technical Reports provided by 

the NOP and public comment to make their final recommendations 

In some cases, NOSB may wish to convene a TAP instead of requesting a TR, for review 

of complex or controversial substances. 

Step 4: Subcommittee may develop a discussion document based on the petition and 

forward that document to the full board and post it for public discussion 

At the discretion of the Subcommittee (SC), the SC may develop a discussion document 

to: 

• Solicit public comment about the material prior to a proposal being developed

• Provide opportunity for full board discussion prior to a proposal being written

• Allow the petitioner to hear public and board comments and give them an 

opportunity to submit petition addendums prior to a Subcommittee proposal and 

vote

A petition discussion document is optional, but if used, could allow for full board 

discussion of a material while a technical review is in process or if the SC determines a 

full board discussion would benefit the writing of the SC proposal on the material.

Step 5: Third Party Technical Review 

During this phase the NOP will:

• Assign a contractor to develop a Technical Review (TR) or Technical Advisory Panel 

(TAP). The third-party contractor must have technical expertise relevant to the 

petition, and will use the TR template provided by NOP. 

• Review all TRs or TAP reports before they are distributed to the Subcommittee to 

ensure they meet the requirements of the contract.

NOSB October 2019 proposals and discussion documents Page 174 of 230
• Ensure that TRs/TAP reports are sufficient and complete when they are distributed 

to the Subcommittee 

Third party experts may consist of contractors, or employees of the USDA, such as AMS 

Science and Technology, AMS Agricultural Analytics Division, Agricultural Research 

Service, or other federal agencies with appropriate expertise, as needed. 

Step 6: Technical Review Sufficiency Determination 

During this phase the Subcommittee (Crops, Livestock or Handling) will: 

Review the draft TR to ensure that it:

• Is consistent in format, level of detail, and tone

• Is technically objective and free from opinions or conjecture 

• Is written in a style appropriate for non-technical readers (e.g. free of 

technical jargon)

• Is prepared using a well-defined and consistent procedure consisting of 

information gathering, information synthesis and document preparation, 

and quality assurance 

• Is based on the best available information that can be obtained within the 

designated time frame

• Is thoroughly supported using literature citations

• Addresses all evaluation questions in the TR template

The Subcommittee chair will notify the NOP, within 60 days of receiving the TR, that 

the TR is sufficient. If the TR is not found sufficient, the Subcommittee must provide 

the NOP with an explanation of why, including a request for additional information 

or improvements.

If necessary, the NOP will seek improvements or supplemental information from the 

contractor. Once the Technical Reports are deemed sufficient, the NOP will post on 

the NOP website.

Step 7: Review by the Subcommittee (Crops, Livestock or Handling) 

 During this phase the Subcommittee conducting the review will: 

• Read the review, along with the submitted petition, and any additional 

information available, such as literature referenced in the Technical Review, 

personal knowledge, public or board comments from the optional petition 

discussion document, and recommendations of a contracted panel of experts 

when utilized. 

• Subcommittee members will prepare a written review of the substance

according to the OFPA criteria. 

• After discussion, the Subcommittee will vote on classification (e.g., synthetic, 

nonsynthetic, agricultural) for substances not previously classified, and vote on 

a proposed action (e.g., add to National List, remove, or amend)

• The review, including record of votes, will be finalized as a proposal for the next 

meeting. 

NOSB October 2019 proposals and discussion documents Page 175 of 230
• All proposals must be submitted to NOP for posting 45 days before the public 

meeting date. 

Step 8: Action by Full NOSB 

 During this phase the NOP will: 

• Publish the proposals on the NOP website and provide a minimum of 30 days of 

written public comment on the proposal prior to the public NOSB business 

meeting. 

• Include sufficient time on the agenda at the NOSB meeting for the Board to 

discuss the proposal, listen to public comments, and make a recommendation. 

At the NOSB meeting: 

• The Subcommittee Chair or delegated lead reviewer for each Subcommittee will 

present the proposals at the NOSB meeting. The proposals are to be presented 

in the form of a seconded motion coming from the Subcommittee, and the Chair 

will open the motion for discussion. After discussion board members will vote 

on the motion. 

• Voting may be by show of hands, roll call, or by use of modern voting devices.

• The NOSB Secretary will record the votes of each NOSB member and the Chair 

will announce whether or not the motion passed. 

Step 9: The NOSB Chair will review all final recommendations and submit them to the NOP 

Changes to annotations, classification of materials, or proposal to remove.

The NOSB may request to review an existing substance on the National List without a new 

petition when they have justification to support a revision of the annotation, a

reclassification of the substance, or removal of a substance. This may happen as a result of 

the sunset review process, or based on new information provided in a Technical Review, or 

from public comment. The following procedure should be followed:

• The Subcommittee sends a written request for a new work agenda item to the 

Executive Subcommittee.

• The request should include a summary of the issue, brief justification for the 

change, and resources in hand or needed for the project. 

• The ES considers the request and determines if it should go forward. 

• NOP reviews the item for possible addition to the work agenda, and may 

propose to add to a future meeting schedule depending on NOSB workload.

• The Subcommittee develops a proposal for consideration that is separate from 

the sunset review of the substance. NOP will then consider rulemaking action in 

a timely manner, without constraints due to the sunset timeline. 

Additional considerations concerning Technical Reviews

Basic principles that should be considered when consulting with a third-party expert: 

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• A Subcommittee cannot proceed with a recommendation to list a material if it is 

determined that there is insufficient valid scientific information on that material’s 

impact on the environment, human health and its compatibility with organic principles. 

• The decision to request a third-party expert needs to be made independently of the 

availability of funds. If there is a lack of funding to secure third party expert advice, the 

Subcommittee has the option to place the review of new petitions on hold. 

• The Subcommittee determines the completeness of the petition and whether a 

Technical Review is needed. 

• The decision to define the expertise of the third-party expert is the responsibility of the 

Subcommittee reviewing the material or issue. 

• To incorporate a diversity of opinions and to minimize the risk of bias, a Subcommittee 

may seek information from a range of technical experts (individuals or institutions). The 

Subcommittee may also ask questions in their posted proposals, in order to gain needed 

information from the public. 

The NOP will seek Technical Reviews from a range of experts. The name of the 

contracted party will appear on the Technical Review. All Federal contracts, including 

those issued by USDA/NOP to Technical Report contractors, are governed by the Federal 

Acquisition Regulations (FAR). The FAR includes a “Subpart 3.11—Preventing Personal 

Conflicts of Interest for Contractor Employees Performing Acquisition Functions,” which 

requires contractors to identify and prevent personal conflicts of interest for their 

covered employees. “Personal conflict of interest” means a situation in which a covered 

employee has a financial interest, personal activity, or relationship that could impair the 

employee’s ability to act impartially and in the best interest of the Government when 

performing under the contract.

Link: https://www.acquisition.gov/far/current/pdf/FAR.pdf

Definitions

Technical Review - A report prepared by a third-party expert under contract addressing 

the environmental, human, and industrial impact of a petitioned material per the OFPA 

and regulatory evaluation criteria to aid in the thorough evaluation of that material by 

the NOSB.

Technical Advisory Panel (TAP) - Group of third-party experts convened by the Board to 

provide a technical review related to a material petition under review by the NOSB. 

V. Prioritization of Petitions 

Petitions received and deemed eligible and sufficient by the NOP/NOSB will be prioritized as 

follows:

Priority 1: A petition or proposal to remove a material presently on the National list that raises 

serious health, environmental, or regulatory concerns, including petitions to reconsider 

previous decisions, will be given the highest priority - Priority 1, above all other petitions in the 

queue of the reviewing Subcommittee (Crops, Handling, or Livestock). 

Priority 2: A petition or proposal to remove a material presently on the National list not based 

on serious health, environmental, or regulatory concerns, but based on other new information, 

such as commercial availability status, would be assigned a Priority 2, behind Priority 1

petitions, but above any petitions to list materials that are in the queue of the reviewing 

Subcommittee (Crops, Handling, or Livestock). This priority assignment would include any 

removal petitions requesting reconsideration of previous board decisions, if the resubmitted 

NOSB October 2019 proposals and discussion documents Page 177 of 230
petition contains substantive new information to warrant reconsideration. 

Priority 3: A petition to add a material to the National List will be considered by the reviewing 

Subcommittee (Crops, Handling, or Livestock) in the chronological order in which it was 

received, and will be designated as Priority 3. 

Priority 4: A petition to reconsider adding a material that had previously been rejected by a 

Board vote would be given the lowest priority - Priority 4, and would go to the bottom of the 

Subcommittee (Crops, Handling, or Livestock) queue of petitioned materials. Petitions 

submitted for reconsideration must contain substantive new information to warrant 

reconsideration.

This prioritization guideline is only that, a guideline. When situations occur beyond the control 

of the reviewing Subcommittee, such as, but not limited to, technical report budgetary 

constraints, or a delay in the delivery of a technical review for a petitioned substance, the work 

agenda may require adjustment by the NOSB and NOP. 

VI. Withdrawal of a petition by a petitioner

A petition may be withdrawn at any point in the process, prior to the vote by Subcommittee. 

Once a Subcommittee develops a proposal, the outcome will be posted for public comment 

and the NOSB will vote at the next public meeting. When a petition is withdrawn by the 

petitioner prior to Subcommittee proposal, the Subcommittee will suspend its review and 

recommendation procedure. Withdrawals will not be accepted after the Subcommittee votes 

on a proposal. 

If a petition is re-submitted, the NOSB will review it in the order in which it was received. Thus, 

a re-submitted petition should be considered a new request and will be placed at the end of 

the queue of materials pending review. 

A petitioner has the opportunity to withdraw a petition with the intent of improving it (e.g., 

conducting additional research), and may also voluntarily submit supplemental information. 

VII. Sunset Review Process 

The Organic Foods Production Act of 1990 (OFPA) authorizes a National List of Allowed and 

Prohibited Substances (7 U.S. C. Section 6517). Sections 6517 (e) mandates a Sunset Provision 

as follows: 

“No exception or prohibition 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 and the Secretary has renewed such 

exemption or prohibition.”

The NOP published a Federal Register notice on Sept. 16, 2013 (78 FR 56811) describing current 

procedures for sunset review. Through the sunset review process, the NOSB can recommend to 

USDA the removal of substances based on adverse impact on human health, the environment, 

or other criteria under the Organic Foods Production Act (OFPA). If upon review the NOSB 

believes the substance no longer fits the criteria for an exemption or prohibition, the NOSB can 

recommend (by a decisive two thirds vote, 7 USC Section 6158 (i)) to remove the substance 

from the National List. After the NOSB has completed this "sunset" review, the USDA must 

renew or remove the substances on the National List to complete the process. All substances 

NOSB October 2019 proposals and discussion documents Page 178 of 230
under sunset review will be considered over two NOSB meetings, to provide ample opportunity 

for public notice and comment. The NOSB observes the following procedure. 

A. Steps in the Sunset Review Process (See Member Guide for forms used in these steps.) 

Step 1: The NOSB Subcommittees submit the initial Sunset List Summary for posting

which may include requests for specific information. The NOP posts the list as well as the 

NOSB Meeting Announcement in the Federal Register which invites comments, at least 

30 days prior to the first public meeting on these sunset substances.

Step 2: The public submits written comments, which are analyzed by Subcommittees. 

Step 3 (Public Meeting #1): Subcommittees summarize background and public comment 

& receive oral comment.

Step 4: Subcommittees analyze written and oral comments from Meeting #1 and prepare 

a Preliminary Review that includes a motion to remove the substance from the National 

List. The NOP publishes the next meeting announcement in the Federal Register, inviting 

comment on the Preliminary Reviews, which are posted on the NOP website. 

Step 5: Written public comments submitted and analyzed by Subcommittees

Step 6 (Public Meeting #2): Subcommittees present Preliminary Review, receive oral 

comment, and discuss the proposal with the full Board. When presented to the full 

NOSB, reviews will contain a motion and second taken in Subcommittee. Motions for 

removal based on the Preliminary Review are voted on by the full Board, and require a 

decisive two-thirds (2/3) majority to pass.

At Meeting #2, the NOSB completes the Sunset Review and submits the final documents 

to the NOP. 

Step 7: AMS reviews the NOSB Sunset Review and considers rulemaking action for any 

recommended removals. This will include a proposed rule open for public comment 

before a final rule amendment is published. 

Step 8: AMS issues Federal Register Notice announcing renewal of applicable substances 

Note: this is a regulatory process for determining whether materials already approved 

or prohibited on the National List should be removed. Due to regulatory process 

constraints, it is not possible to modify existing listings, add new uses of a listed 

substance during sunset review, or change annotations. If there is a need to consider 

changing an annotation or re-classifying a material, a Subcommittee may request to 

develop a separate proposal that will be reviewed separately from the sunset review 

process. Decisions made through the Sunset review should be transparent, nonarbitrary, based on the best current information and in the interest of the organic 

community and public at large.

NOSB October 2019 proposals and discussion documents Page 179 of 230
VIII. NOSB PROCEDURES

A. BOARD MEETINGS 

All Board meetings, assembled for the purpose of making recommendations to the NOP, are 

subject to FACA (see appendix B for FACA facts) and as such must be open to the public and 

must meet public notification requirements. Not all meetings are subject to FACA and do not 

require public notification. Examples of these exempted meetings include: Subcommittee calls, 

assemblies for completing work, planning retreats, training or sharing information. The date and 

location of in-person Board Meetings, currently held twice each year in spring and fall, will to 

the extent possible, be set at the mutual scheduling convenience of the NOSB and the NOP.

B. CONDUCTING BUSINESS

NOSB public meetings in brief: 

• Approximately 3 days long depending on workload

• Meetings are held in various venues across the country to allow for participation by 

stakeholders that otherwise may not be able to attend due to travel constraints 

• A typical meeting agenda includes presentations by the NOP, presentations of proposals and

discussion documents by the NOSB Subcommittees, discussion time and votes on each 

proposal, public comment, NOSB officer elections, and a review of work agendas 

Quorum: As specified in OFPA, a majority of the members of the NOSB shall constitute a 

quorum for the purpose of conducting business. (7 USC 6518 (h)). In cases of a medical situation 

preventing attendance in person, a virtual presence is permitted. 

Decisive votes: As specified in OFPA, two-thirds (2/3) of the votes cast at a meeting of the NOSB 

at which a quorum is present shall be decisive of any motion (7 USC Section 6518(i)). All 

abstentions will be recorded as such and will not be included as part of the total vote cast in 

case of decisive votes. Similarly, all NOSB members who recuse themselves due to conflicts of 

interest, or are absent, shall be recorded as such and their votes will not be counted towards 

the total number of votes cast. Both abstentions and recusals will be considered in order to 

establish a quorum.

Calculation of Decisive Votes

# Votes Cast # Recusals and 

Abstentions 2/3 Majority*

15 0 10

14 1 10

13 2 9

12 3 8

11 4 8

10 5 7

9 6 6

8 7 6

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C. PARLIAMENTARY PROCEDURES

No procedures or business of the NOSB shall be taken in conflict with OFPA, FACA or other 

pertinent laws (herein referred to as governing legislation). For parliamentary procedure, all 

motions and votes not covered under the governing legislation shall be governed by this Policy 

and Procedure Manual if directly addressed. If procedures, motions and votes are not directly 

addressed in the Policy and Procedures Manual, they shall be governed by Robert’s Rules of 

Order Newly Revised. The NOSB adopted the use of Robert’s Rules of Order in March 1992, but 

modified its use as only a non-mandatory guide in May 1993. Roberts Rules may be adapted to 

meet the special requirements of a group. Because the NOSB is also subject to the OFPA, FACA 

and USDA, a designated NOP staff member may act as an informal Parliamentarian to advise the 

Chair. 

D. NOSB DELIBERATIONS AND RECOMMENDATIONS

Board actions include but are not limited to: adoption of a proposal as presented by the 

Subcommittee, non-substantive amendments* and then adoption of a proposal, rejection of a 

proposal, or referral of the proposal back to Subcommittee for further development. 

* Substantive vs. non-substantive amendments. 

The following criteria shall be considered when determining if a proposal will be amended at the 

NOSB meeting, or must be referred back to Subcommittee and resubmitted for the next Board 

meeting. The DFO or designee will determine whether a proposed amendment to a proposal is 

substantive. 

• The extent to which a reasonable person affected by the recommendation would have 

understood that the published proposal would affect his or her interests

• The extent to which the subject of the recommendation or the issues determined in it are 

substantially different from the subject or issues involved in the proposal

• The extent to which the effects of the recommendation differ from the effects of the 

proposal

Procedure for submitting final recommendations to NOP

Within 30 days after the completion of the NOSB meeting all final recommendations must be 

submitted to the NOP using the following procedure:

Each proposal lead prepares the following documents: 

o A recommendation cover sheet (See Member Guide). The cover sheet should 

contain all appropriate information, including the vote recorded at the meeting. 

(The NOP can provide the voting record)

o The proposal that was voted on at the meeting 

The proposal leads will forward the documents to the appropriate Subcommittee Chair 

who will review them for accuracy and completeness, sign and date them, and then 

forward them to the Board Chair and the DFO/ACS.

NOSB October 2019 proposals and discussion documents Page 181 of 230
E. PUBLIC COMMENT 

The NOP and NOSB encourage public comment and work collaboratively to increase 

opportunities for greater participation by a broad range of people, employing various modes of 

communication and modern technology whenever possible. Individuals may present oral 

comment at either a pre-meeting electronic webinar or at the in-person NOSB meeting. 

Before Public Meetings:

Written comment: All members of the public are encouraged to submit public comment in 

writing according to the Federal Register Notice. Written submissions: allow NOSB members the 

opportunity to read comments in advance, eliminate or decrease the need for paper copies to 

be distributed during the meeting and allow each NOSB member to review and analyze data and

information well ahead of the public meeting and possible voting. 

Oral Comments 

Oral comments: May be received via a virtual meeting/webinar. Public notice of such electronic 

meetings will be included in the Federal Register notice announcing the public meeting. Such 

electronic pre-meetings may allow individuals more time to present their data or information, 

reduce the need to attend the public meeting in person, reduce our carbon footprint, and give 

the NOSB more time to absorb the information. Such electronic meetings shall be recorded and 

made available to the public and to NOSB members.

Comments at In-Person Public Meetings:

• All persons wishing to comment at NOSB meetings during public comment periods must, in 

general, sign-up in advance per the instructions in the Federal Register Notice for the 

meeting. 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 and will depend on 

availability of time.

• All presenters are encouraged to submit public comment in writing according to the Federal 

Register Notice. Written 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.

• Persons will be called upon to speak according to a posted schedule. However speakers 

should allow for some flexibility. Persons called upon who are absent from the room could 

potentially miss their opportunity for public comment.

• 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 the NOP, working closely with the NOSB Chair in advance of the meeting.

• Persons must give their names and affiliations for the record at the beginning of their public 

comment.

• Proxy speakers are not permitted.

• Public comments may be scheduled according to topic.

NOSB October 2019 proposals and discussion documents Page 182 of 230
• Individuals providing public comment shall refrain from making any personal attacks or

remarks that might impugn the character of any individual.

• 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.

Policy for Public Communication between NOSB Meetings (Adopted April 11, 2013)

• The NOSB and NOP seek public communication outside of Board biannual meetings and 

public comment periods to inform the NOSB and NOP of stakeholders’ interests, and to 

comment on the NOSB’s and NOP’s work activities year around.

• The NOSB may post draft discussion documents and proposals between public meetings for 

review and public comment. Timely submission of comments will assist the NOSB and its 

Subcommittees in revising such documents for subsequent NOSB review.

F. ELECTION OF OFFICERS 

Nominations

• Any NOSB member is eligible for consideration for any officer position

• An NOSB member may self-nominate or may be nominated by another member of the 

NOSB 

• Should the Chair, Vice Chair, or Secretary resign or fail to serve the full term, the Executive 

Subcommittee shall appoint an interim officer. The interim officer shall serve in that 

capacity until the next regularly scheduled meeting of the NOSB, during which an election 

will be held to fill the remainder of the term

• Members may serve more than one term in any officer position.

Voting schedule 

• Officers shall be elected for one-year terms by majority vote at the fall NOSB meeting. 

• Newly elected officers will assume their positions at the conclusion of the Fall NOSB 

meeting, and assume the responsibilities thereof at that time

• Outgoing NOSB officers will assist the incoming officers with the transition into their new 

roles, to be completed no later than January 23rd of the following year.

Counting of Votes

• Voting will be by secret ballot immediately following nominations for each office. 

• Ballots for officers will be cast in the following order:

1. Chair

2. Vice Chair

3. Secretary

• Ballots will be counted for one office and the Secretary will announce the tally before the 

next office is opened for nominations. 

• The Secretary and Vice chair will prepare and distribute the ballots, then collect them after 

each vote. 

• The Secretary will tally the votes and the Chair will verify the results. 

• The first nominee to receive a majority of votes will be elected. If no nominee receives the 

majority of votes, the nominee with the least votes will be eliminated and a revote will 

occur with the remaining candidates. This process will be repeated until a nominee obtains 

NOSB October 2019 proposals and discussion documents Page 183 of 230
a majority. 

• In the event of a tie there will be a revote until a nominee obtains a majority. All nominees 

will be included in the revote. 

• Votes will remain confidential, and ballots will be disposed of by the Chair or Secretary. 

• A nominee may withdraw at their discretion at any time.

• In the event of only one nominee for office, the vote may be by acclimation. 

G. MISCELLANEOUS PROCEDURES

 

1. Invited Speakers

• Subcommittees, the NOSB or the NOP may identify the need for presentations and 

speakers regarding subjects of interest or concern to be addressed at NOSB meetings. 

• Requests must be made by the NOSB chair to the NOP no less than 60 days prior to the 

target NOSB meeting. 

• Speakers must be approved and invited by the NOP. 

If approved by the NOP, the purpose for the presentation, the subject area and the 

bio/resume of speaker(s) should be circulated via email to the entire Board at least 2 

weeks prior to the Board meeting. 

Current petitioners cannot be invited to be speakers about the topic under discussion, 

unless invited by the NOSB Chair. 

Speakers are expected to disclose any financial interests that he or she has that can be 

reasonably assumed to influence his or her presentation content. 

2. Surveys Conducted on Behalf of NOSB Subcommittees 

• All surveys, including electronic surveys, conducted on behalf of the NOSB, must be 

approved by the NOSB Executive Subcommittee before they are submitted for approval 

to USDA, and 

• A written report summarizing the results of the survey must be submitted to the full 

Board and the NOP as soon as possible after completion.

IX. REVISIONS TO THE POLICY AND PROCEDURES MANUAL

• The PDS will review the PPM each year and, working in collaboration with the NOP, determine if 

any updates are necessary. 

• Proposed changes will be subject to review and approval by the NOP and the full NOSB. 

NOSB October 2019 proposals and discussion documents Page 184 of 230
X. APPENDICES 

A. Appendix 1: FOUNDATIONS 

1. NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING 

(NOSB Recommendation Adopted October 17, 2001)

 

1.1 Organic agriculture is an ecological production management system that promotes and 

enhances biodiversity, biological cycles, and soil biological activity. It emphasizes the use of 

management practices in preference to the use of off-farm inputs, taking into account that 

regional conditions require locally adapted systems. These goals are met, where possible, 

through the use of cultural, biological, and mechanical methods, as opposed to using synthetic 

materials to fulfill specific functions within the system. 

1.2 An organic production system is designed to: 

1.2.1 Optimize soil biological activity; 

1.2.2 Maintain long-term fertility; 

1.2.3 Minimize soil erosion; 

1.2.4 Maintain or enhance the genetic and biological diversity of the production system and 

its surroundings; 

1.2.5 Utilize production methods and breeds or varieties that are well adapted to the region; 

1.2.6 Recycle materials of plant and animal origin in order to return nutrients to the land, thus 

minimizing the use of non-renewable resources; 

1.2.7 Minimize pollution of soil, water, and air; and 

1.2.8 Become established on an existing farm or field through a period of conversion 

(transition), during which no prohibited materials are applied and an organic plan is 

implemented. 

1.3 The basis for organic livestock production is the development of a harmonious relationship 

between land, plants, and livestock, and respect for the physiological and behavioral needs of 

livestock. This is achieved by: 

1.3.1 Providing good quality organically grown feed; 

1.3.2 Maintaining appropriate stocking rates; 

1.3.3 Designing husbandry systems adapted to the species' needs; 

1.3.4 Promoting animal health and welfare while minimizing stress; and 

1.3.5 Avoiding the routine use of chemical allopathic veterinary drugs, including antibiotics.

 

1.4 Organic handling practices are based on the following principles: 

1.4.1 Organic processors and handlers implement organic good manufacturing and handling 

practices in order to maintain the integrity and quality of organic products through all 

stages of processing, handling, transport, and storage; 

1.4.2 Organic products are not commingled with non-organic products, except when 

combining organic and non-organic ingredients in finished products which contain less 

than 100% organic ingredients; 

1.4.3 Organic products and packaging materials used for organic products do not come in 

contact with prohibited materials; 

NOSB October 2019 proposals and discussion documents Page 185 of 230
1.4.4 Proper records, including accurate audit trails, are kept to verify that the integrity of 

organic products is maintained; and 

1.4.5 Organic processors and handlers use practices that minimize environmental degradation 

and consumption of non-renewable resources. Efforts are made to reduce packaging; 

use recycled materials; use cultural and biological pest management strategies; and 

minimize solid, liquid, and airborne emissions. 

1.5 Organic production and handling systems strive to achieve agro-ecosystems that are 

ecologically, socially, and economically sustainable. 

1.6 Organic products are defined by specific production and handling standards that are intrinsic 

to the identification and labeling of such products. 

1.7 Organic standards require that each certified operator must complete, and submit for 

approval by a certifying agent, an organic plan detailing the management of the organic crop, 

livestock, wild harvest, processing, or handling system. The organic plan outlines the 

management practices and inputs that will be used by the operation to comply with organic 

standards. 

1.8 Organic certification is a regulatory system which allows consumers to identify and reward 

operators who meet organic standards. It allows consumers to be confident that organic 

products are produced according to approved management plans in accordance with organic 

standards. Certification requires informed effort on the part of producers and handlers, and 

careful vigilance with consistent, transparent decision making on the part of certifying agents.

 

1.9 Organic production and handling operations must comply with all applicable local, state, and 

federal laws and address food safety concerns adequately. 

1.10 Organic certification, production, and handling systems serve to educate consumers 

regarding the source, quality, and content of organic foods and products. Product labels must 

be truthful regarding product names, claims, and content. 

1.11 Genetic engineering (recombinant and technology) is a synthetic process designed to control 

nature at the molecular level, with the potential for unforeseen consequences. As such, it is 

not compatible with the principles of organic agriculture (either production or handling).

Genetically engineered/modified organisms (GE/GMOs) and products produced by or through 

the use of genetic engineering are prohibited. 

1.12 Although organic standards prohibit the use of certain materials such as synthetic fertilizers, 

pesticides, and genetically engineered organisms, they cannot ensure that organic products 

are completely free of residues due to background levels in the environment. 

NOSB October 2019 proposals and discussion documents Page 186 of 230
2. NOSB GUIDANCE ON COMPATIBILITY WITH A SYSTEM OF SUSTAINABLE AGRICULTURE AND 

CONSISTENCY WITH ORGANIC FARMING AND HANDLING 

(NOSB Recommendation Adopted April 29, 2004)

 

A significant responsibility of the NOSB is to determine the suitability of materials for use in 

organic production and handling. Among the criteria the Board must consider, OFPA requires the 

NOSB to determine the compatibility of a material with organic practices. The following questions 

were developed by the NOSB to assist in determining the compatibility of materials with organic 

practices. 

 

In order to determine if a substance, its use, and manufacture are compatible with a system of 

sustainable agriculture and consistent with organic farming and handling, and in consideration of 

the NOSB Principles of Organic Production and Handling, the following factors are to be 

considered: 

• Does the substance promote plant and animal health by enhancing the soil’s physical 

chemical, or biological properties? 

• Does use of the substance encourage and enhance preventative techniques including cultural 

and biological methods for management of crop, livestock, and/or handling operations? 

• Is the substance made from renewable resources? If the source of the product is nonrenewable, are the materials used to produce the substance recyclable? Is the substance 

produced from recycled materials? Does use of the substance increase the efficiency of 

resources used by organic farms, complement the use of natural biological controls, or reduce 

the total amount of materials released into the environment? 

• Does use of the substance have a positive influence on the health, natural behavior, and 

welfare of livestock? 

• Does the substance satisfy expectations of organic consumers regarding the authenticity and 

integrity of organic products? 

• Does the substance allow for an increase in the long-term viability of organic farm operations? 

• Is there evidence that the substance is mined, manufactured, or produced through reliance on 

child labor or violations of applicable national labor regulations? 

• If the substance is already on the National List, is the proposed use of the substance 

consistent with other listed uses of the substance? 

• Is the use of the substance consistent with other substances historically allowed or disallowed 

in organic production and handling? 

• Would approval of the substance be consistent with international organic regulations and 

guidelines, including Codex? 

• Is there adequate information about the substance to make a reasonable determination on 

the substance's compliance with each of the other applicable criteria? If adequate information 

has not been provided, does an abundance of caution warrant rejection of the substance? 

• Does use of the substance have a positive impact on biodiversity? 

3. NOSB MEMBER DUTIES

To fulfill their responsibilities, Board members agree to adhere to the following Duties.

Duty of Care 

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: 

NOSB October 2019 proposals and discussion documents Page 187 of 230
• 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. 

• Participate in decisions - Board members are bound by responsibility to be active participants 

in decision making. Absence from a meeting is no protection from the responsibility for 

decisions made at the meeting. 

• Make decisions with the care of an ordinary prudent person in a similar position - The law 

requires Board members to exercise the judgment of an ordinary prudent person who may be 

faced with a similar issue. 

Duty of Loyalty 

The Duty of Loyalty requires Board members to exercise their power in the interest of the organic 

community and the public at large, and not in their own interest or the interest of another entity 

or person. In dispatching their Duty of Loyalty, Board members must: 

• Address conflicts of interest - Board members bring to the NOSB particular areas of expertise 

based upon their personal and business interests in organic production and marketing. 

Because Board members may have interests in conflict with those of the public they must be 

conscious of the potential for such conflicts and act with candor and care. Board members 

must abide by the NOSB conflict of interest policy. 

• Recognize corporate opportunity - Before a Board member votes upon an issue in which they 

have a direct financial interest, that Board member must disclose the transaction to the Board 

in sufficient detail and adequate time to enable the Board to act, or decline to act, in regard to 

such transaction. 

Duty of Obedience 

Board members are bound to obey the tenants of the laws and regulations governing organic 

production, processing and marketing. To this effect, Board members must: 

• Act within the requirements of the law - Board members must uphold all state and federal 

statutes, including the Federal Advisory Committee Act (FACA – 5 U.S.C. App. 2 et seq.) 

• Adhere to the responsibilities of the Board as defined by the Organic Foods Production Act of 

1990 

• Adhere to the requirements specified in the NOSB Policy and Procedures Manual

NOSB October 2019 proposals and discussion documents Page 188 of 230
B. Appendix 2: FACA FACTS

The Federal Advisory Committee Act (FACA) (5 U.S.C. App.2) and its implementing regulations 

(41 CFR Part 101-6.10) govern the creation, operation, and termination of advisory committees 

in the Executive Branch of the Federal Government. The National Organic Standards Board 

(NOSB) is a Department of Agriculture (USDA) non-discretionary advisory committee required by 

the Organic Foods Production Act of 1990, as amended. 

• Advisory committees must be chartered before they can meet or conduct any business. 

Charters must be renewed every two years, or they will be terminated under the sunset 

provisions of Section 14 of the FACA, unless otherwise provided by law. 

• Advisory committee meetings are required to be open to the public, with limited exceptions 

as provided for in Section 552b of title 5, United States Code. Meetings not subject to FACA 

include NOSB briefing meetings initiated by the USDA to exchange facts and information, 

member orientation and training, and NOSB Subcommittee meetings. Such meetings are not 

subject to FACA because they are not conducted for the purpose of providing the USDA with 

NOSB advice or recommendations. 

• Designated Federal Officers must approve all meetings and agendas, and attend meetings. 

The Advisory Board Specialist is the NOSB’s Designated Federal Officer. 

• Meeting notices and agendas must be published in the Federal Register to accommodate 

public participation. Although not required by FACA, the NOP strives to: 

o Post a provisional agenda on its web site no later than 90 days before the meeting is 

scheduled to begin 

o Post a final agenda, on its web site, no later than 45 days before the meeting is scheduled 

to begin

o The NOP will strive to publish notice of the next NOSB meeting in the Federal Register as 

early after the previous NOSB meeting as possible. This notice will serve as an “open 

docket” in which public comment can be received by the NOP and NOSB. 

Notwithstanding the above, the NOP will publish notice of the meeting in the Federal 

Register no later than 45 days before the meeting is scheduled to begin 

• While meeting transcripts are not required under FACA, the NOP provides transcripts or 

meeting notes to support the transparency of Board meetings and to support subsequent 

rulemaking activities. The NOP also issues a short meeting summary, which is required by 

FACA, after each biannual meeting that summarizes the key issues discussed, and the 

outcome of voting. 

• Advisory committee documents must be available for public inspection and copying until the 

committee ceases to exist. 

• Interested persons shall be permitted to attend, appear before, or file statements with any 

advisory committee, subject to reasonable rules or regulations. 

• Additional information may be found at the FACA homepage: 

http://www.gsa.gov/portal/content/100916

NOSB October 2019 proposals and discussion documents Page 189 of 230
NOSB October 2019 proposals and discussion documents Page 190 of 230
National Organic Standards Board

Livestock Subcommittee Proposal 

Use of Excluded Method Vaccines in Organic Livestock Production 

July 16, 2019 

Introduction and Background

There are two areas in the organic regulations that address use of vaccines; one on the National List (NL) 

of allowed and prohibited substances, and one in the section that details excluded methods. Through 

public comment and direct interaction with certifiers and organic producers, it became apparent that 

there are inconsistencies between certifiers about which vaccines are allowed. Some certifiers do not

allow the use of excluded method vaccines, relying on the NOP regulation at §206.105 (e) which only 

allows use of this type of vaccine if it has gone through NOSB review and NOP placement on the 

National List. Other certifiers allow any type of vaccine to be used, and may or may not inquire if the 

vaccine has been produced through excluded methods. These certifiers rely on the presence of vaccines 

on the National List at §205.603(a)(4) without any restriction or clarifying annotation.

This issue was reviewed by the NOSB in October 2014: “Findings and Recommendations in Response to 

September 2010 NOP Memorandum on Livestock Vaccines Made With Excluded Methods”. Challenges 

that prevented immediate attention to this issue included: having an updated definition of excluded 

methods that determines if new technologies were to be excluded methods for organic, having a clear 

understanding if there were non-excluded method vaccine equivalents to excluded-method-derived 

vaccines, and how to provide for use of excluded method vaccines if there was an emergency when only 

an excluded method vaccine could address the problem in a timely way. 

In November 2017, the NOSB passed a recommendation that addresses how to determine if specific 

technologies should be considered excluded or not, with descriptions, terminology, and a listing of 

excluded, not excluded, and yet-to-be-determined methods. The NOSB will use this recommendation to 

review new technologies as they develop. The October 2014 NOSB recommendation lists commonly 

used vaccines that are known to have been made through excluded method technology. The NOSB 

strives to correct this inconsistency, to increase the trust of the organic certification system and provide 

consistency and certainty for organic livestock producers. 

The Subcommittee recognizes the importance vaccines play in the prevention of livestock disease. When 

an organic livestock producer loses one or more of their animals, there is the loss of the animal’s 

production capability, as well as a loss of time and resources associated with the breeding and selection 

that resulted in that specific animal. Breeding and selection often take years or even decades. When an 

animal is lost, all of those years of breeding and their unique genetics are also lost. The use of vaccines 

as a preventative can protect this long-term investment in genetic improvement, and vaccines remain

an important tool in the organic livestock producer’s toolbox to protect the investments that producers 

have in individual animals as well as their herds or flocks. The possibility of a livestock health emergency 

is real, and the NOSB is putting forth this proposal to have clarity in the use of vaccines from excluded 

methods, to provide certainty and consistency to both producers and certifiers in the determination of 

which specific vaccines can be used with organic livestock.

NOSB October 2019 proposals and discussion documents Page 191 of 230
Relevant Areas of the Rule and Guidance

From the NOP Rule:

§205.2 Terms defined

 Biologics. All viruses, serums, toxins, and analogous products of natural or synthetic origin, 

such as diagnostics, antitoxins, vaccines, live microorganisms, killed microorganisms, and the 

antigenic or immunizing components of microorganisms intended for use in the diagnosis, 

treatment, or prevention of diseases of animals.

 Commercial availability. 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.

 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). Such methods do not include the use of 

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

culture.

§205.105 Allowed and prohibited substances, methods, and ingredients in organic production and 

handling. To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified 

ingredients or food group(s)),” the product must be produced and handled without the use of: 

(e) Excluded methods, except for vaccines: Provided, That, the vaccines are approved in accordance with 

§205.600(a)

§205.600 Evaluation criteria for allowed and prohibited substances, methods, and ingredients.

The following criteria will be utilized in the evaluation of substances or ingredients for the organic 

production and handling sections of the National List: 

(a) Synthetic and nonsynthetic substances considered for inclusion on or deletion from the National List 

of allowed and prohibited substances will be evaluated using the criteria specified in the Act (7 U.S.C. 

6517 and 6518). 

The preamble to the National Organic Program final rule (65 FR 80547, December 21, 2000) states: 

The Act allows use of animal vaccines in organic livestock production. Given the general 

prohibition on the use of excluded methods, however, we believe that animal vaccines 

produced using excluded methods should not be allowed without an explicit consideration of 

such materials by the NOSB and without an affirmative determination from the NOSB that they 

meet the criteria for inclusion on the National List. It is for that reason that we have not granted 

this request of commenters but, rather, provided an opportunity for review of this narrow range 

of materials produced using excluded methods through the National List process.

NOSB October 2019 proposals and discussion documents Page 192 of 230
Excerpt from NOP Memo to NOSB dated September 30, 2010: 

The NOP’s understanding is that excluded methods are prohibited under Section §205.105(e) 

except for vaccines. Further, this exception applies to vaccines that are produced through 

excluded methods only if those GMO vaccines are approved according to 205.600(a). Vaccines 

are listed under §205.603(a)(4) under “Biologics-Vaccines”. The NOSB has not reviewed vaccines 

in accordance with §205.600(a). The listing under §205.603(a)(4) of Biologics-Vaccines does not 

include the allowance of GMO vaccines. The NOP requested a legal review from USDA’s Office of 

General Counsel (OGC) to determine whether vaccines produced through excluded methods are 

currently allowed under 205.603(a)(4). The OGC opinion supports the position that GMO 

vaccines are allowed only if they are approved according to 205.600(a). 

The NOP recommends that the NOSB review GMO vaccines under the provisions of §205.600(a). 

The NOP suggests that the Board request a technical review for biologics-vaccines, including the 

status of genetically modified vaccines and an assessment of the economic impact of using 

commercial availability criteria for non-genetically modified vaccines. After the Board completes 

the evaluation according to the OFPA criteria, it may submit a recommendation to the NOP to 

add GMO vaccines to the National List of Allowed and Prohibited Substances.

 

Discussion and Goals of this Proposal

The Livestock Subcommittee strongly supports the use of vaccines as an essential component of 

maintaining animal health and promoting animal welfare. Vaccines are an essential tool for livestock 

producers to prevent serious health events in both individual animals as well as their entire herds or 

flocks. Interstate and international movement of livestock may require specific vaccinations for animals 

to be transported and sold. Currently, § 205.105(e) requires excluded method vaccines be reviewed and 

placed on the National List before use. This approach is impractical for a variety of reasons: 

• There are new individual vaccines continually being developed; the NOSB will have difficulty 

reviewing these in a timely manner.

• Putting each of the excluded method vaccines on the NL is a lengthy process (2+ years) and 

puts organic livestock at risk in emergency situations when that vaccine may be needed 

immediately.

• Some excluded method vaccines may be patented and there may be confidential information 

that will not allow NOSB standard review of the material.

• Both the European Union and Canadian organic standards do not differentiate between the 

use of excluded method vaccines or standard vaccines, putting US organic livestock producers 

at a disadvantage when addressing animal disease.

• Some certifiers observe this restriction, and do not currently allow any excluded method 

vaccines, while others ignore this restriction and allow excluded method vaccines, or do not 

determine if a vaccine is made from an excluded method. This inconsistency causes problems 

for some producers and may lead to “certifier-shopping”. Any time we can correct an 

inconsistency, we increase the trust of the organic certification system for both producers and 

consumers.

The NOSB, supported by the majority of public comment, is committed to not endorsing the blanket use 

of excluded method technologies. We seek to find a pragmatic way to stand against pervasive use of 

excluded methods in organic agriculture and foods, while being practical in accepting the fact that 

sometimes the only vaccines that are available are those made with excluded method technology. 

NOSB October 2019 proposals and discussion documents Page 193 of 230
In our discussion, we reviewed three options: 

1. Allow all vaccines without any review or consideration if they were produced through excluded 

methods.

2. Allow vaccines from excluded methods, but only if they were individually reviewed and 

approved by the NOSB and placed on the National List by the NOP.

3. Allow vaccines from excluded methods, but only if a vaccine is not “commercially available” that 

had not been produced from excluded methods to effectively treat that health issue.

For option 1, the NOSB considered the issues below if there would be an allowance of excluded method 

vaccines “as a class” with no restriction.

• This is what is currently done in Europe and Canada. 

• Less documentation needed by operators and certifiers. 

• Allows for use of needed vaccines in an emergency with no restrictions. 

• New excluded method technologies might provide additional animal health effects beyond just 

control of a specific disease, having a carte blanche approach might have unintended 

consequences beyond our intention of preventing animal illness.

• Might open the door to more use of excluded methods in organic.

For option 2, the NOSB considered these issues if there was no change to the current two references in 

the USDA organic regulations, both within the regulatory text and on the National List.

• Use of vaccines from excluded methods, at times the only vaccine to prevent the health issue, 

would not be available to some producers since their certifiers will continue to follow the 

current regulation as written.

• Certifiers who currently allow the use of excluded method vaccines, would continue to ignore 

the language of the regulation that requires these vaccines be in the National List before use, 

leading to a lack of consistency in implementation of the regulation, as well as confusion in the 

certification community resulting in some areas of the regulation to be ignored without 

consequences.

• The NOSB would need to solicit petitions for review of excluded method vaccines that are 

currently in use, to place them on the National List. Optimistically, the placement of these 

vaccines on the NL would take 2 to 4 years. 

• In the case of a livestock disease outbreak, that can only be treated by excluded method 

vaccines, organic livestock producers would be at a disadvantage due to the lag time between 

the petitioning of a new excluded method vaccine and its eventual possible placement on the 

National List.

For option 3- change to the regulatory language could require that vaccines from excluded methods only 

be used when there are no commercially available vaccines produced without excluded methods. 

Allowance for the use of nonorganic seeds and some nonorganic agricultural products in processed 

organic foods, is currently allowed when there is no “commercially available” organic alternative. The 

term “commercially available” is defined in the USDA organic regulations as:

Commercially available. 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. 

NOSB October 2019 proposals and discussion documents Page 194 of 230
• A clear definition of how “commercial availability” will be applied when searching for vaccines 

made without excluded method technology and what documentation is sufficient to prove this 

search.

• Operators and certifiers are accustomed to “commercial availability” since it applies to use of 

organic seed and agricultural products found on §205.606.

• Would allow for quick use of an excluded vaccine in an emergency, when no other option is 

available.

• Encourages market availability of vaccines not made with excluded methods by providing

organic buyers for these vaccines and showing a need for their continued manufacture.

• Might be difficult to clearly identify which vaccines are from excluded methods and which are 

not. Currently there is a list of widely used vaccines, but there may be others in use regionally 

or sporadically that are not listed.

Public Comment

At the April 2019 NOSB meeting, a discussion document was circulated with the following options and 

questions provided to the public for comment. 

1. Follow the requirements of § 205.105 (e) and start reviewing known excluded method vaccines 

for individual placement on the National List. 

2. Approve all vaccines produced through excluded methods as a “class” of vaccines and place this 

class of vaccines on § 205.603(a)(4).

3. Change § 205.105 (e) to read as follows:

(e) Excluded methods, except for vaccines: Provided, That, there are no commercially available 

vaccines that are not produced through excluded methods to prevent that specific animal 

disease or health problem.

In addition, please provide information on the following:

4. What type of documentation would be used to prove non-commercial availability of vaccines 

produced without excluded methods?

5. When reviewing vaccines under commercial availability, are there special issues that should be 

considered?

The significant majority of the public responses supported option 3, changing the regulatory language to 

allow use of vaccines from excluded methods when no other vaccines were commercially available. 

There were some commenters that supported allowing all vaccines as a class, with no consideration 

applied if the vaccine was produced from excluded methods or not. There were no comments 

supporting the current regulatory language, which has led to inconsistency among certifiers in 

implementation of the regulation.

Determining commercial availability of a vaccine not produced through excluded method technology

The definition of commercial availability can be applied to vaccines in this manner. 

• The vaccine is available in the specific route of delivery required by the operator (Injection, 

needle-free or transdermal, intranasal, ocular, oral, spray, topical.) (FORM)

NOSB October 2019 proposals and discussion documents Page 195 of 230
• Information is present that details similar or not similar efficacies of the excluded and nonexcluded method vaccines for that specific illness or health problem (QUALITY)

• Sufficient volume of the vaccine is present for the operator to purchase in their region, within 

the timeframe necessary for perishable vaccines, to vaccinate their livestock. (QUANTITY)

Resources to determine if a vaccine had or had not been produced through excluded methods

Commenters expressed concern that it could be difficult for both operators and certifiers to determine if 

there are commercially available vaccines not made from excluded methods. There are some 

references to aid in this determination. The August 2014 NOSB document, entitled “Findings and 

Recommendation in Response to September 2010 NOP Memorandum on Livestock Vaccines Made With 

Excluded Methods”, provides a variety of references and labeling options to aid producers and certifiers 

in determining if the vaccine may have been produced using excluded method. A summary is excerpted 

here, with more detail found in the original document.

Label Guidelines: CVB (Center for Veterinary Biologics) regulations require that certain vaccine seed 

configurations have specific terms on the labels of branded vaccine products. These terms are required 

for a subset of biotechnology derived vaccines. While these terms are not added to the labels because an 

excluded method was used, CVB states that all such vaccines were created using methods that the NOP 

would exclude. The terms on labels that identify vaccines were made with excluded method are 

“Subunit,” “Vector,” and “Chimera.” Because these vaccines are labeled with the identified terms, CVB 

can disclose a trade names list for all of these vaccines.

Product Code: The CVB requires that every biologic, including vaccines, produced must have a product 

code. The CVB guide on true names and product codes notes that the 5th digit of the product code may 

contain “D” or “R.” The letter “D” in the fifth digit signifies that the vaccine is a nucleic acid vaccine. Such 

vaccines, also called DNA vaccines, are made with excluded methods and depend upon foreign genes 

being expressed in some of the cells of the vaccinated animals. The letter “R” in the fifth digit signifies 

the vaccine has a recombinant component or is a subunit protein derived from a recombinant organism. 

The recombinant designation only applies to components in the vaccine and not to methods used to 

make the vaccine such as genetically engineered cells that are used for cell culturing the vaccine seed. 

In addition, the terms nucleic acid vaccine, naked DNA vaccine, RNA vaccine and genetic vaccine may be 

used to label vaccines produced through methods that are considered excluded by the NOSB.

An important reference is the USDA publication “Veterinary Biological Products- Licensees and 

Permittees”, with the most current version from July 1, 2019 present at this link 

https://www.aphis.usda.gov/animal_health/vet_biologics/publications/CurrentProdCodeBook.pdf

Operators and certifiers can refer to this publication, and when using the coding system discussed above 

by the CVB, it would be the first step to determine if a vaccine, had or had not been produced through 

excluded method technologies. As a final confirmation, certifiers could provide an affidavit for 

manufacturers to complete detailing whether or not their vaccines were produced through excluded 

methods, using the list of excluded method technologies maintained by the NOSB. The APHIS 

publication also lists vaccines that had not been produced through excluded technologies that target the 

same disease, and would facilitate the search for commercially available vaccines that had not been 

produced through excluded methods. 

NOSB October 2019 proposals and discussion documents Page 196 of 230
Another source of information is present in the NOSB requested Technical Review of “Vaccines Made 

from Genetically Modified Organisms” from 2011. While this information is somewhat dated, it can be 

used as a starting point for updating using more recent information.

Table 1. Selected Conventional and GMO Vaccines Used for Food Animalsa

Disease Conventional vaccine/strain GMO vaccine/strain

Bacterial

Brucellosis (ruminants) Brucella abortus, strain 19, strain 

RB51

None identified

Brucellosis (swine) Brucella suis, strain 2 None identified

Anthrax (bovine, ovine, equine) Bacillus anthracis, strain Sterne None identified

Johne’s disease Mycobacterium paratuberculosis

strain 316F

None identified

Contagious bovine

pleuropneumonia

Mycoplasma mycoides subsp.

mycoides SC, strain T1/44

None identified

Avian salmonellosis Salmonella enteric servo.

Gallinarium, strain R9

Salmonella typhimurium vaccine,

live culture

Table 1. Selected Conventional and GMO Vaccines Used for Food Animalsa

Disease Conventional vaccine/strain GMO vaccine/strain

Bovine salmonellosis None identified Salmonella dublin vaccine

Poultry cholera Pasturella multocida (various

strains)

None identified

Cattle pasteurellosis Manheimia (Pasteurella)

haemolytica (various strains)

None identified

Swine atropic rhinitis Bordetella bronchiseptica (various

strains)

None identified

Bovine clostridiosis Clostridium perfringens None identified

Escherichia Coli in poultry Escherichia coli vaccine, avirulent

live culture

Escherichia coli vaccine, live 

culture 

Viral

Avian encephalomyelitis Live and modified live virus Avian encephalomyelitis-fowl 

pox-laryngotracheitis vaccine

Porcine circovirus (swine) Type 2, killed virus Porcine circovirus vaccine (Type

1 -Type 2 chimera, killed virus; 

and Type 2 killed, baculovirus 

vector)

Marek’s disease (poultry) Live strains of Marek’s disease

virus, serotypes 1, 2, or 3 

Marek's Disease-Newcastle

Disease live virus vaccine, 

Serotypes 1 & 2 & 3, live 

Marek's disease vector; and 

Marek’s disease live herpesvirus 

chimera

Newcastle disease (poultry) Bursal-disease-newcastle

disease-bronchitis vaccine, 

killed or live virus; live virus 

VG/GA strain; killed virus; and 

B1 type, B1 strain live virus 

Newcastle disease-fowl pox

vaccine, live fowl pox vector; 

and Marek's disease-Newcastle 

disease vaccine, serotype 3, live 

Marek's disease vector 

NOSB October 2019 proposals and discussion documents Page 197 of 230
Bursal disease (poultry) Live or killed avian bursitidis 

infectivae virus type 1 

Bursal disease-Marek's disease 

vaccine, Serotype 3, live Marek's 

disease vector

Fowl pox Live fowl pox vaccine Fowl pox-laryngotracheitis 

vaccine, live fowl pox vector

Fowl laryngotracheitis Modified live virus vaccine Fowl pox-laryngotracheitis 

vaccine, live fowl pox vector

aSources: Frey (2007); USDA (2011)

Lastly, certifiers and the NOP could communicate with each other and develop a listing of excluded 

method vaccines, that do not have any commercially available equivalents and that were not produced 

through prohibited technologies, as well as excluded method vaccines that do have a commercially 

available equivalent that were not produced through excluded method technologies. Manufacturers of 

vaccines not produced through excluded method technologies, could choose to be OMRI listed as well. 

Public interest groups may also choose to do some of the research to aid certifiers and operators in 

understanding which vaccines are or are not produced through excluded methods.

The NOSB understands that this will add another layer of review for some operators, however, with the 

2+ years of lag time between NOSB approval of this regulatory change, and a NOP final rule, the 

identification and tracking system for the various types of vaccines could be put in place.

The NOSB continues to work on determining which types of technologies should be excluded from 

allowance in organic production, with a complete list of the reviewed technologies provided in the most 

recent recommendation. The NOSB, through this work, can provide the organic community with the 

excluded method determinations needed when new technologies are put into commercial use.

The current rule reads:

§205.105 Allowed and prohibited substances, methods, and ingredients in organic production and 

handling.

To be sold or labeled as “100 percent organic,” “organic,” or “made with organic (specified ingredients 

or food group(s)),” the product must be produced and handled without the use of: 

(e) Excluded methods, except for vaccines: Provided, That, the vaccines are approved in accordance with 

§205.600(a)

Subcommittee proposal

The NOSB Livestock Subcommittee recommends the following change to the National Organic Program 

Final Rule §205.105 (e) (Changes to the current rule noted in bold). 

Motion to change the USDA organic regulations at §205.105 (e). (Additions to the current rule 

noted in bold). 

(e) Excluded methods, except for vaccines: Provided, That, vaccines produced through excluded 

methods may be used when an equivalent vaccine not produced through excluded methods is 

not commercially available.

NOSB October 2019 proposals and discussion documents Page 198 of 230
Subcommittee Vote

Motion to change the USDA organic regulations at § 205.105 (e). Addition to the current rule noted 

in bold. 

(e) Excluded methods, except for vaccines: Provided, That, vaccines produced through excluded 

methods may be used when an equivalent vaccine not produced through excluded methods is 

not commercially available.

 

Motion by: Harriet Behar 

Seconded by: Ashley Swaffar

Yes: 5 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

Approved by Sue Baird, Subcommittee Chair, to transmit to NOSB July 17, 2019

NOSB October 2019 proposals and discussion documents Page 199 of 230
NOSB October 2019 proposals and discussion documents Page 200 of 230
Sunset 2021

Meeting 2 - Review

Livestock Substances §205.603 

October 2019

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the 

National List of Allowed and Prohibited Substances (National List) that are coming up for sunset review 

by the National Organic Standard Board (NOSB). The following list announces substances that are on the 

National List for use in organic livestock production that must be reviewed by the NOSB and renewed by 

the USDA before their sunset dates in 2021. This list provides the substance’s current status on the 

National List, use description, references to past technical reports, past NOSB actions, and regulatory 

history, as applicable. 

Request for Comments

Written public comments will be accepted through October 3, 2019 via www.regulations.gov. 

Comments received after that date may not be reviewed by the NOSB before the October meeting. 

NOSB October 2019 proposals and discussion documents Page 201 of 230
Sunset 2021

Meeting 2 - Review

Livestock Substances §205.603 

October 2019

Note: The materials included in this list are undergoing early sunset review as part of the November 18, 

2016, NOSB recommendation on efficient workload re-organization. 

Reference: 7 CFR 205.603 Synthetic substances allowed for use in organic livestock production 

Atropine

Hydrogen peroxide

Iodine (§205.603(a))

Iodine (§205.603(b))

Magnesium sulfate

Parasiticides: Fenbendazole

Parasiticides: Moxidectin

Peroxyacetic/Peracetic acid 

Xylazine

DL-Methionine

Trace minerals

Vitamins

NOSB October 2019 proposals and discussion documents Page 202 of 230
Atropine

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (3) Atropine 

(CAS #-51-55-8)—federal law restricts this drug to use by or on the lawful written or oral order of a 

licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug 

Administration regulations. Also, for use under 7 CFR part 205, the NOP requires:

(i) Use by or on the lawful written order of a licensed veterinarian; and

(ii) A meat withdrawal period of at least 56 days after administering to livestock intended for 

slaughter; and a milk discard period of at least 12 days after administering to dairy animals. 

Technical Report: 2002 TAP; 2019 Technical Report 

Petition(s): 2002 Petition 

Past NOSB Actions: 05/2003 sunset recommendation; 04/2010 sunset recommendation; 10/2015 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022 

Subcommittee Review: 

Background 

Atropine sulfate, typically referred to as atropine, is an anti-cholinergic derived from atropa belladonna 

(deadly nightshade) roots; it is isolated via various synthetic extraction processes. Atropine sulfate 

belongs to a group of medicines called antimuscarinic agents and can be administered by tablet, 

intravenously, injection, or can be absorbed through the skin. It is a highly controlled substance, 

administered under orders of a licensed veterinarian. The withdrawal periods of 56 days and 12 days are 

twice the listed FARAD Withdrawal Interval (WDI). According to the 2019 TR, atropine is itself toxic, with 

the risk of toxicity dependent on the relative ability of various species to metabolize atropine (cattle and 

pigs are the agriculturally most sensitive to atropine toxicity).

Range of uses 

Atropine is administered to block or reverse the adverse effects caused by some medicines and is used 

to relieve the symptoms of organophosphate poisoning. Atropine is commonly administered as a 

pretreatment for anesthesia during surgical procedures (EMEA 1998, USDA 2002). The same

antimuscarinic properties that provide relief for organophosphate poisoning also works to reduce 

secretions (e.g., sweat, saliva) and relax smooth muscles prior to the administration of anesthesia, 

reducing the risk of airway obstruction (Jones et al. 1977, USDA 2002, Brunton et al. 2006, EFSA 

2008). Atropine, typically given intravenously or by injection into a muscle, is often administered with 

many anesthetic agents to prevent the slowing of the heart rate during surgery. After surgery Atropine 

is effective as a bradycardia treatment to raise heart rates following anesthesia in surgical procedures. 

Atropine has several ophthalmic (eye-care) applications due to its ability to induce pupil dilation and 

cycloplegic properties (paralysis of eye muscles) (EMEA 1998, Herring et al. 2000). When applied to the 

eye, these relaxations act to reduce pain and dilate pupils, making it useful for treatment in equine 

uveitis and as a presurgical treatment for cataract extractions. Atropine also affects iris permeability for 

glaucoma treatments....” (Herring et al. 2000, Williams et al. 2000, 106 MedlinePlus 2017)

International allowance for use 

According to the 2019 TR, atropine is listed on the Canadian General Standards Board Permitted 

Substances List. However, it is not listed for use under:

NOSB October 2019 proposals and discussion documents Page 203 of 230
• CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and 

Marketing of Organically Produced Foods;

• European Economic Community (EEC) Council Regulations;

• Japan Agricultural Standard (JAS) for Organic Production; or

• International Federation of Organic Agriculture Movements (IFOAM).

Environmental contamination

According to the 2019 TR, “Due to the limited application of atropine (for veterinary medicine, approved 

for use only when used or ordered by a veterinarian), and the small quantities administered 

(milligrams), atropine is unlikely to be a source of environmental contamination....” The 2019 TR also 

states that “There are no reported studies on the persistence or concentration of atropine (neither Dhyoscyamine nor L-hyoscyamine), or the metabolized products tropine and tropic acid, although tropine 

has been identified as ‘readily biodegradable’ .... Tropine has also been identified as toxic to aquatic 

invertebrates, including Daphnia magna (water fleas) at concentrations of 54.7 mg/L....”

Effect on human health

According to the 2019 TR, “Atropine is most commonly administered intravenously, although it may also 

be applied via ingestion, or ocular absorption (applied directly to the eye) .... Intravenous administration 

of the substance using proper medical protocols (e.g., gloves, premeasured doses) makes inadvertent 

human absorption unlikely. Due to the neurophysiological profile of atropine, its absorption also poses 

toxicological concerns. Atropine intoxication is associated with symptoms including abdominal pain, 

confusion and disorientation, hallucinations, urinary retention, hypothermia and tachycardia .... 

Atropine toxicity can be lethal in humans, however, the level of toxicity and its relationship to fatal 

outcomes is not well defined.”

Natural (non-synthetic) alternatives

According to the 2019 TR, “Atropine is recognized as the most efficient treatment option for 

organophosphate poisoning within both human and veterinary medicine....” The TR also states that 

“Magnesium sulfate (MgSO4) is approved for use in organic livestock production at 7 CFR 205.603, and is 

being studied as a potential alternative or additional treatment to atropine administration for 

organophosphate treatment protocols....” However, this substance “has seen little clinical applications, 

and more studies are required to evaluate its effectiveness compared to traditional atropine and 

atropine oxime combination treatments....”

Public Comment from the Spring 2019 NOSB Meeting

In written comments submitted for the spring 2019 NOSB meeting, five commenters supported relisting 

atropine as essential for use in organic animal production. Two more commenters stated that atropine 

was included in the organic system plan of operations they certified. No commenters expressed 

opposition to relisting.

Subcommittee Vote: 

Motion to remove atropine from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Dan Seitz

Seconded by: Scott Rice

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

NOSB October 2019 proposals and discussion documents Page 204 of 230
Hydrogen peroxide

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (15) Hydrogen 

peroxide.

Technical Report: 1995 TAP (Crops); 2015 TR (Crops)

Petition(s): N/A

Past NOSB Actions: 11/2005 sunset recommendation; 04/2010 sunset recommendation; 

10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420)

Sunset Date: 3/15/2022 

Subcommittee Review:

Hydrogen peroxide is used as a readily available disinfectant and broad-spectrum germicide. It is an 

important cleaning agent for use on contact surfaces, such as equipment, calf pails, bottles, and utensils. 

The material is used to clean wounds and was first registered with the EPA in 1977.

Hydrogen peroxide is a very simple molecule with a formula of H2O2. Virtually all modern production 

facilities manufacture commercial hydrogen peroxide solutions using large, strategically located 

anthraquinone autoxidation processes. Improved production methods and facilities based on the 

anthraquinone (AO) process have recently appeared in the commercial patent literature. 

Hydrogen peroxide is a naturally occurring inorganic compound; however, the sources of hydrogen 

peroxide used in commercial fungicides, disinfectants and antiseptic products are produced through 

chemical synthesis. Industrial methods for the preparation of hydrogen peroxide are categorized as 

oxidation-reduction reactions. Modern commercial methods for hydrogen peroxide synthesis involve 

the transition-metal catalyzed chemical reduction of an alkyl anthraquinone with hydrogen (H2) gas to 

the corresponding hydroquinone followed by regenerative oxidation of the latter species in air.

Contamination is not expected when purified forms of hydrogen peroxide are released to the 

environment following normal use. At typical pesticide concentrations, hydrogen peroxide is expected 

to rapidly degrade to oxygen gas and water (US EPA, 2007). Large-volume spills and other releases of 

concentrated hydrogen peroxide could present a fire hazard since the substance readily decomposes to 

release oxygen gas. Pure hydrogen peroxide is not flammable and can be diluted with clean water to 

minimize the risk of fire. Although concentrated hydrogen peroxide is nonflammable, it is a powerful 

oxidizing agent that may spontaneously combust on contact with organic material and becomes 

explosive when heated. Combustion reactions and explosions resulting from accidental spills of 

concentrated hydrogen peroxide could therefore lead to environmental degradation.

During the Spring 2019 NOSB review the Livestock Subcommittee received comments in favor of 

relisting hydrogen peroxide and no comments against relisting. One commenter stated hydrogen 

peroxide is one of the most widely used hard-surface sanitizers and is Generally Recognized as Safe 

(GRAS) as an antimicrobial agent and for other purposes by the FDA. Unlike many alternatives available 

to organic producers, it is an excellent choice as it rapidly degrades to oxygen and water, leaving no 

residue.

Hydrogen peroxide is recommended for relisting based on the available technical advisory panel (TAP)

of October of 1995 (Crops), the technical review of October 2015, the unanimous NOSB 2017 support of

this material, and the lack of new scientific or meritorious information. 

NOSB October 2019 proposals and discussion documents Page 205 of 230
Questions

Is this synthetic material a necessary input in organic livestock production?

Subcommittee Vote:

Motion to remove hydrogen peroxide from §205.603(a) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Jesse Buie

Seconded by: Ashley Swaffar

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

Iodine—§205.603(a)

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (16) Iodine.

Technical Report: 1994 TAP; 2015 TR 

Petition(s): N/A

Past NOSB Actions: 04/1995 meeting minutes and vote; 11/2005 sunset recommendation; 04/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Background from Subcommittee 

Iodine has excellent antimicrobial qualities and is widely used in organic livestock production as a topical 

treatment, disinfectant, and antimicrobial, especially as a teat dip used both pre-milking and post 

milking.

Mastitis is a painful inflammation with infection. Antibiotic use is prohibited in organic agriculture so 

preventive healthcare is of critical importance. While a clean barn, clean milking parlor and clean cows 

are a vital aspect of an organic milk production system, barns are not sterile environments and thus antimicrobial teat dips used in pre and post milking are vital preventive healthcare products. There are 

many teat dips available commercially. Iodine based teat dips are the most commonly used in organic 

livestock production. Iodine can be in molecular form or iodophor form.

Typically, molecular iodine is “complexed” into a variety of iodophors where surfactants are mixed with 

molecular iodine to enhance water solubility and sequester the molecular iodine for extended release in 

disinfectant products. There may also be several other ingredients in iodine-based teat dips, some of 

which may be excipients.

Additional information requested from subcommittee

1. Can iodophor forms of iodine be produced using fewer toxic surfactants than nonphenol 

polyethylene glycol ether (NPE) and similar NPEs? If so, what might be substituted?

2. If the use of NPE surfactants was prohibited in teat dips for use in organic livestock production 

how would this impact the organic industry?

NOSB October 2019 proposals and discussion documents Page 206 of 230
3. Are there equally effective alternatives to iodophor based teat dips for commercial use in 

organic livestock production?

Public Comments

During the Spring 2019 NOSB the Livestock Subcommittee received several comments in favor of 

relisting iodine and no comments against relisting iodine. Comments in favor of relisting included the 

following: 

• This product is widely used as a teat dip

• This is a critically important product 

Subcommittee Discussion

This material satisfies the OFPA evaluation criteria and the Livestock Subcommittee supports the 

relisting of iodine.

Subcommittee Vote:

Motion to remove iodine from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Ashley Swaffar

Seconded by: Jesse Buie

Yes: 0 No: 5 Abstain: 0 Absent: 1 Recuse: 0

Iodine—§205.603(b)

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable. 

(4) Iodine.

Technical Report: 1994 TAP; 2015 TR 

Petition(s): N/A

Past NOSB Actions: 04/1995 meeting minutes and vote; 11/2005 sunset recommendation; 04/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Iodine has excellent antimicrobial qualities and is widely used in organic livestock production as a topical 

treatment, disinfectant, and antimicrobial, especially as a teat dip used both pre-milking and post 

milking.

Mastitis is a painful inflammation with infection. Antibiotic use is prohibited in organic agriculture so 

preventive healthcare is of critical importance. While a clean barn, clean milking parlor and clean cows 

are a vital aspect of an organic milk production system, barns are not sterile environments and thus antimicrobial teat dips used in pre and post milking are vital preventive healthcare products. There are 

many teat dips available commercially. Iodine based teat dips are the most commonly used in organic 

livestock production. Iodine can be in molecular form or iodophor form.

Typically, molecular iodine is “complexed” into a variety of iodophors where surfactants are mixed with 

molecular iodine to enhance water solubility and sequester the molecular iodine for extended release in 

NOSB October 2019 proposals and discussion documents Page 207 of 230
disinfectant products. There may also be several other ingredients in iodine-based teat dips, some of 

which may be excipients.

Additional information requested from Subcommittee

1. Can iodophor forms of iodine be produced using fewer toxic surfactants than nonphenol 

polyethylene glycol ether (NPE) and similar NPEs? If so, what might be substituted?

2. If the use of NPE surfactants was prohibited in teat dips for use in organic livestock production 

how would this impact the organic industry?

3. Are there equally effective alternatives to iodophor based teat dips for commercial use in 

organic livestock production?

Public Comments

During the Spring 2019 NOSB the Livestock Subcommittee received several comments in favor of 

relisting iodine and no comments against relisting iodine. Comments in favor of relisting included the 

following: 

• This product is widely used as a teat dip

• This is a critically important product 

Subcommittee Discussion

This material satisfies the OFPA evaluation criteria and the Livestock Subcommittee supports the 

relisting of iodine.

Subcommittee Vote: 

Motion to remove iodine from §205.603(b) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Ashley Swaffar

Seconded by: Jesse Buie

Yes: 0 No: 5 Abstain: 0 Absent: 1 Recuse: 0

Magnesium sulfate

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (19) Magnesium 

sulfate.

Technical Report: 1995 TAP; 2011 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Specific Uses of the Substance 

Magnesium sulfate has a number of veterinary uses. It acts as an anticonvulsant, laxative, 

NOSB October 2019 proposals and discussion documents Page 208 of 230
bronchodilator, electrolyte replacement aid with hypomagnesaemia, and may be used to treat cardiac 

arrhythmias. Specifically, in swine, magnesium sulfate is administered to treat malignant hypothermia.

Magnesium sulfate can be added to livestock feed to treat conditions stemming from a magnesium 

deficiency. Lactation tetany or grass tetany occurs when ruminants graze on grasses low in magnesium 

or suffer from a low level of magnesium in their diet. The condition is often realized after cases of 

sudden death in cattle. Clinical signs include convulsions and muscular spasms, and death may occur due 

to respiratory failure. If livestock are feeding on pastures with high potassium levels, which interfere 

with the uptake of magnesium by grasses, supplemental magnesium sulfate may be needed. 

 

Magnesium capsules can be inserted into the rumen of livestock and after a one-week stabilization 

period, the capsule begins to release magnesium for up to 80 days. This capsule is recommended for use 

in high-risk or valuable animals. It is advised that, in addition to the capsule, the livestock be fed hay in 

order to increase absorption of the magnesium. If immediate treatment for magnesium deficiency is 

needed, magnesium sulfate can be administered intravenously. 

A magnesium lick can also be provided for livestock to increase the amount of magnesium in the diet. 

Because magnesium sulfate is not palatable, molasses is added to the magnesium lick to encourage 

cattle‘s use. Licks are generally 80 percent molasses and 20 percent magnesium sulfate and are 

considered to be less reliable than supplementing feed with magnesium.

Magnesium sulfate, as Epsom salts, can be used to treat inflammation and abscesses in livestock. 

Soaking the affected area in a mixture containing Epsom salt and water can reduce signs of 

inflammation.

Additional information requested from subcommittee

1. Is this material still considered to be essential for organic livestock production?

Public Comments

During the Spring 2019 NOSB review the Livestock Subcommittee received several comments in favor of 

relisting magnesium sulfate and no comments against relisting. Some of the comments in favor of 

relisting included:

• Magnesium sulfate is essential for organic livestock production. It is used when grass tetany and 

organophosphate poisoning occur. Both are acute situations and an effective immediate 

treatment is necessary.

• This product is administered by the intravenous or intramuscular routes as an electrolyte 

replenisher or anticonvulsant. Magnesium sulfate is used as a laxative and bronchodilator. This 

product is also added to feed to treat magnesium deficiency. Accordingly, this product is 

important to the humane treatment of organic animals.

Subcommittee Discussion

Magnesium sulfate satisfies the OFPA evaluation criteria and the Livestock Subcommittee supports 

relisting. 

NOSB October 2019 proposals and discussion documents Page 209 of 230
Subcommittee Vote:

Motion to remove magnesium sulfate from §205.603(a) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Ashley Swaffar

Seconded by: Scott Rice

Yes: 0 No: 5 Abstain: 0 Absent: 1 Recuse: 0

Parasiticides, Fenbendazole

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (23) 

Parasiticides—Prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder 

stock when organic system plan-approved preventive management does not prevent infestation. Milk or 

milk products from a treated animal cannot be labeled as provided for in subpart D of this part for 90 

days following treatment. In breeder stock, treatment cannot occur during the last third of gestation if 

the progeny will be sold as organic and must not be used during the lactation period for breeding stock. 

(i) Fenbendazole (CAS #43210-67-9)— milk or milk products from a treated animal cannot be labeled 

as provided for in subpart D of this part for: 2 days following treatment of cattle; 36 days following 

treatment of goats, sheep, and other dairy species.

Technical Report: 1999 TAP (Fenbendazole, Ivermectin); 2015 TR 

Petition(s): 03/2007 Fenbendazole

Past NOSB Actions: 05/2008 NOSB recommendation; 10/2015 sunset recommendation; 04/2016 

recommendation – annotation change

Recent Regulatory Background: Added to National List , effective May 16, 2012 (77 FR 28472); Renewed 

03/15/2017 (82 FR 14420); Proposed rule 01/17/2018 (83 FR 2498); Annotation change 12/27/2018 (83 

FR 66559)

Sunset Date: 3/15/2022 

 

Subcommittee Review: 

Background from Subcommittee

In veterinary medicine the term parasiticide refers to anthelmintic drugs. Anthelmintics are medications 

capable of causing the evacuation of parasitic intestinal worms. As veterinary drugs, parasiticides are 

articles intended for use in treatment or prevention of disease in animals (Section 201(g)(1)(B) & (C) of 

the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(g)(1)(B) & 234 (C)]). The use of parasiticides in 

organic production is strictly confined to emergencies and the practice of returning livestock production 

to a healthy steady state does not include the routine use of parasiticides. Parasitism may be the 

weakest link in organic livestock production (Karreman, 2004). Outbreaks of disease due to nematode 

parasites can happen even in well managed flocks. When changes in a production system occur as a 

result of land use, weather, or transient exposure of susceptible animals to parasites the natural 

imbalance favors parasite infestation. When unnoticed, undetected and without treatment parasite 

infestation can lead to disease and potentially death (Stockdale, 2008). 

A petition for inclusion of fenbendazole on the National List was received by the NOP, March 23, 2007. 

Fenbendazole was added to the National List effective May 12, 2012. A Technical Review (TR) was 

completed in 2015 to review fenbendazole, ivermectin, and moxidectin as one group. The TR 

documented that parasiticide resistance management has become an important issue in animal health 

NOSB October 2019 proposals and discussion documents Page 210 of 230
and that increased use of anthelmintics in livestock production may lead to subsequent selection and 

increased parasiticide resistance (Xu et al., 1998; James et al., 2009). As a result, if resistance to one 

drug occurs, then other drugs with the same mode of action or binding site will also be ineffective.

Fenbendazole works very well for susceptible parasites; however, some worms have a natural 

mechanism that causes subtle mutations in the genes for the β-tubulin and ion channel proteins 

targeted by these anthelmintics, allowing the worms in subsequent generations to avoid drug binding 

and enables drug resistance. Fenbendazole acts selectively by binding to nematode β-tubulin, disrupting 

the nematode digestive system and preventing egg formation, while potentiating the GLUCL channel 

which causes spastic paralysis. 

Fenbendazole is sold as Panacur and Safe Guard. The orally administered product contains polysorbate 

80, simethicone emulsion 30%, benzyl alcohol and purified water. Fenbendazole paste contains the 

excipients carbome homopolymer type B (Allyl pentaerythritol crosslinked), propylene glycol, glycerin, 

sorbitol, sodium hydroxide, water, methylparaben and propylparaben.

Risks with the use of fenbendazole

The risks associated with chemical treatment of parasites include (1) immediate non-target effects, (2) 

obligation for repeat treatments, (3) potential risk to domestic animals and human health, (4) target 

organism resistance to the treatment, (5) potential residue buildup and (6) potential food chain 

contamination (Rudd, 1985). All FDA livestock approved parasiticides are synthetically produced 

substances shown by experimental and clinical studies to be safe for application to food animals. The 

excipients are usually United States Pharmacopoeia (USP) grade chemicals and also subject to FDA 

approval. 

Fenbendazole is insoluble in water and excreted in the feces. Because it is not soluble, there is little 

mobility of fenbendazole in soils with low risk of groundwater contamination. Laboratory tests show 

that radiolabeled fenbendazole is degraded with a half-life of 54 days. The fate of fenbendazole in 

manure and manured soils has been studied under laboratory and field conditions. After a 102- day 

incubation period, 80% of fenbendazole remains. The latter was accompanied by 4% of the 

corresponding metabolite fenbendazole sulfoxide. Fenbendazole-sulfoxide remains in clay soil samples 

after 54 days (Kreuzig et al., 2007). Fenbendazole toxicity was demonstrated in pigeons and doves, 

leading the authors of the study to suggestion a toxic etiology for fenbendazole in birds of the order 

Columbiformes treatment (Howard et al., 2002). 

International Status

The Canadian Organic Production Systems General Principles and Management Standards (CAN/CGSB433, CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and 

Marketing of Organically Produced Foods (GL 32-1999), the European Economic Community (EEC) 

Council Regulation, EC No. 834/2007 and 889/2008, and the Japan Agricultural Standard (JAS) for 

Organic Production all prohibit parasiticides on a routine basis. If there is a specific disease or health 

issue and natural methods are not effective, parasiticides may be used as long as there is a doubling of 

withdrawal times documented. The International Federation of Organic Agriculture Movements 

(IFOAM) additionally prohibits the usage of parasiticides to include a maximum of three courses of 

remedial treatments within 12 months, or one course of treatment if the productive lifecycle of the 

animal is less than one year.

Public Comments

During the Spring 2019 NOSB review the Livestock Subcommittee received all favorable comments in 

favor of relisting fenbendazole, with the exception of one commenter who stated that they believe the 

NOSB October 2019 proposals and discussion documents Page 211 of 230
listing of fenbendazole with a shorter withholding period in the absence adopting the NOSBrecommended definition of emergency would be a violation of OFPA §6517(d)(2). 

Fenbendazole is recommended for relisting. This determination is based on information in the 2015 TAP 

review, the 2016 NOSB unanimous recommendation for an annotation change, the USDA-NOP 

publication of the amended annotation effective January 29, 2019, and because there is no new 

scientific or meritorious information.

Subcommittee Vote: 

Motion to remove fenbendazole from §205.603(a)(23)(i) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Sue Baird

Seconded by: Ashley Swaffar

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

Parasiticides, Moxidectin

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (23) 

Parasiticides—Prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder 

stock when organic system plan-approved preventive management does not prevent infestation. Milk or 

milk products from a treated animal cannot be labeled as provided for in subpart D of this part for 90 

days following treatment. In breeder stock, treatment cannot occur during the last third of gestation if 

the progeny will be sold as organic and must not be used during the lactation period for breeding stock

(ii) Moxidectin (CAS #113507-06-5)— milk or milk products from a treated animal cannot be labeled as 

provided for in subpart D of this part for: 2 days following treatment of cattle; 36 days following 

treatment of goats, sheep, and other dairy species.

Technical Report: 2003 TAP (Moxidectin); 2015 TR

Petition(s): Moxidectin

Past NOSB Actions: 05/2004 NOSB recommendation; 10/2015 sunset recommendation; 04/2016 NOSB 

recommendation - annotation change

Recent Regulatory Background: Added to National List , effective May 16, 2012 (77 FR 28472); Renewed 

03/15/2017 82 FR 14420; Proposed rule 01/17/2018 (83 FR 2498); Annotation change 12/27/2018 (83 

FR 66559)

Sunset Date: 3/15/2022 

Subcommittee Review: 

Background from Subcommittee

In veterinary medicine the term parasiticide refers to anthelmintic drugs, although moxidectin is also 

effective against arthropod parasites. As veterinary drugs, parasiticides are articles intended for use in 

treatment or prevention of disease in animals (Section 201(g)(1)(B) & (C) of the Federal Food, Drug, and 

Cosmetic Act [21 U.S.C. 321(g)(1)(B) & 234 (C)]). The use of parasiticides in organic production is strictly 

confined to emergencies and the practice of returning livestock production to a healthy steady state 

that does not include the routine use of parasiticides. 

Moxidectin, a derivative of nemadectin, is a chemically modified Streptomyces cyanogriseus 

fermentation product (Asato and France, 1990). The NOSB recommended adding moxidectin to the 

National List in 2004 with the restriction that it only be allowed for use to control internal parasites; but 

NOSB October 2019 proposals and discussion documents Page 212 of 230
in the proposed rule published on July 17, 2006 USDA announced its decision that moxidectin would not 

be proposed for inclusion on the National List because of its macrolide antibiotic classification. Based 

upon the public comments received at the NOSB meeting July 17, 2006, the NOP verified the 

information supplied by commenters, and subsequently concurred that moxidectin does not function as 

an antibiotic when used as a parasiticide. In the Final Rule in 2012 NOP added moxidectin to National 

List for the first time. 

The 2015 Technical Review (TR) reviewed moxidectin and fenbendazole. The TR documented that 

parasiticide resistance management had become an important issue in animal health and that increased 

use of anthelmintics in livestock production may lead to subsequent selection and increased parasiticide 

resistance. Moxidectin works very well for susceptible parasites; however, some worms have a natural 

mechanism that causes subtle mutations in the genes for the β-tubulin and ion channel proteins 

targeted by these anthelmintics, allowing worms in subsequent generations to avoid drug binding and 

enables drug resistance. Moxidectin, the only milblemycin approved for use in organic livestock 

production, selectively binds to nematode β-tubulin and potentiating the glutamate-gated chloride 

(GLUCL) channel. Binding β-tubulin disrupts the nematode digestive system and prevents egg formation, 

while potentiating the GLUCL channel causes spastic paralysis. 

Risks with the use of Moxidectin

The risks associated with chemical treatment of parasites include (1) immediate non-target effects, (2) 

obligation for repeat treatments, (3) potential risk to domestic animals and human health, (4) target 

organism resistance to the treatment, (5) potential residue buildup and (6) potential food chain 

contamination (Rudd, 1985). 

Moxidectin is excreted in feces but is both microbially and photo-degraded in dung pats in the soil. It is 

the least toxic to dung beetles of the macrocyclic lactone anthelmintics. Moxidectin peaks in 2 days in 

feces after treatment and decreases to less than 10 ppb by 37 days after treatment. The half-life for 

degradation of moxidectin in the environment may be up to 130 days. 

International Status

Review of the International Organic Standards- The Canadian Organic Production Systems General 

Principles and Management Standards (CAN/CGSB-433, CODEX Alimentarius Commission, Guidelines for 

the Production, Processing, Labelling and Marketing of Organically Produced Foods (GL 32-1999), the 

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008, and the 

Japan Agricultural Standard (JAS) for Organic Production- all shows a commonality: Parasiticides are 

prohibited on a routine basis. If there is a specific disease or health issue and natural methods are not 

effective, parasiticides may be used as long as there is a doubling of withdrawal times documented. The 

International Federation of Organic Agriculture Movements (IFOAM) has additional exception on the 

usage of parasiticides including a maximum of three courses of remedial treatments within 12 months, 

or one course of treatment if the productive lifecycle of the animal is less than one year.

Public Comments

During the Spring 2019 NOSB review the Livestock Subcommittee received all favorable comments for 

relisting moxidectin, with the exception of one commenter, who stated that they believe the listing of 

moxidectin with a shorter withholding period in the absence of adopting the NOSB-recommended 

definition of emergency would be a violation of OFPA §6517(d)(2). 

Moxidectin is recommended for relisting. This determination is based on information in the 2015 TAP 

review, the 2016 NOSB unanimous recommendation for an annotation change, the USDA-NOP 

publication of the amended annotation effective January 29, 2019, and because there is no new 

scientific or meritorious information. 

NOSB October 2019 proposals and discussion documents Page 213 of 230
Subcommittee Vote: 

Motion to remove moxidectin from §205.603(a)(23)(ii) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Sue Baird

Seconded by: Harriet Behar

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

Peroxyacetic/peracetic acid

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (24) 

Peroxyacetic/peracetic acid (CAS #-79-21-0)—for sanitizing facility and processing equipment.

Technical Report: 2000 TAP ; 2016 TR

Petition(s): 2008 Petition

Past NOSB Actions: 11/2000 NOSB recommendation; 04/2010 sunset recommendation; 10/2015 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Background

According to TR (line 88), peracetic acid is listed for use in organic livestock production for sanitizing 

facility and processing equipment. This is consistent with the substance’s primary use in the food 

industry as a bactericide and fungicide for sanitizing and disinfecting structures, equipment and hard 

surfaces. TR line 99 states, peracetic acid may be used in livestock production in dairies – milking parlors, 

dairy production and transfer facilities and equipment – as well as in poultry premises, hatcheries, 

livestock quarters, stables, stalls, pens, cages, and on feeding and watering equipment.

Beginning at TR line 288: The reason for the excellent and rapid antimicrobial effects of peracetic acid is 

its specific capability to penetrate the cell membrane. Once inside the cell, peracetic acid plays a role in 

denaturing proteins, disrupting cell wall permeability, and oxidizing sulfhydryl and sulfur bonds in 

enzymes and other proteins. PAA irreversibly disrupts enzyme systems, which destroys the 

microorganism. The end products of peracetic acid oxidation are acetic acid and water.

Solutions of peracetic acid used as sanitizers are created by combining aqueous mixtures of two 

substances: acetic acid (the acid in vinegar) and hydrogen peroxide. At cool temperatures, acetic acid 

and hydrogen peroxide react over a few days to form an equilibrium solution containing peracetic acid, 

acetic acid and hydrogen peroxide. This equilibrium solution is the substance sold commercially as the 

sanitizer “peracetic acid.”

Peracetic acid is considered to be an environmentally friendly substance, with very little potential to 

cause contamination due to its rapid breakdown into benign substances already present in the 

environment. It has, however, been reported that peracetic acid in the atmosphere can react with 

photochemically produced hydroxyl radicals (reaction half-life of approximately 9 days) (U.S. National 

Library of Medicine 2012), with a suggested role in contributing to acid rain. 

 

NOSB October 2019 proposals and discussion documents Page 214 of 230
Both peracetic acid and hydrogen peroxide have been cited as potential contributors to acid rain. 

However, while peracetic acid and hydrogen peroxide can be involved in chemical reactions in the 

atmosphere that ultimately lead to acid rain, the literature does not cite them as being a significant 

contributor to or source of acid rain. 

 

Peracetic acid has been found in some instances to have beneficial effects related to environmental 

contamination. One study reports peracetic acid to be effective in degrading toxic compounds 

benzo(a)pyrene and methylnaphthalene in lake sediments through oxidation of the parent compound. 

During the Spring 2019 NOSB the Livestock Committee received comments in favor of relisting Peracetic 

Acid no comments against relisting. The commenter stated:

• Peracetic acid (PAA) is an important tool in the prevention of illness through its use as a hard 

surface sanitizer and disinfectant.

• PAA is an effective sanitizer for use against a large number of gram negative and gram positive 

bacteria, fungi and many human health pathogens.

• PAA is found in an aqueous solution of acetic acid and hydrogen peroxide. PAA rapidly degrades 

into acetic acid, oxygen and water, none of which are a toxicological concern. 

The National Organic Standards Board (NOSB) previously reviewed peracetic acid as a disinfectant, 

sanitizer, and medical treatment in accordance with Code of Federal Regulation 7(CFR) § 

205.603(a)(19). Peracetic acid is a relatively recent development, but has been used to clean stalls and 

to disinfect livestock, particularly dairy cattle. Acetic acid and hydrogen peroxide both have a longer 

history of use in livestock production than commercial preparations of peracetic acid, but the substance 

has, in effect, been used by farmers who combine vinegar and peroxide in a cleaning solution. 

Peracetic acid is recommended for relisting based on the available 2000 technical advisory panel (TAP), 

the technical review of March 2016, the unanimous NOSB 2017 support of this material, and the lack of 

new scientific or meritorious information. 

The NOSB has reviewed few materials for use in barns, stalls, stables and milking parlors, leaving 

relatively few options for producers.

Question

Is this still necessary for organic livestock production?

Subcommittee Vote: 

Motion to remove peracetic acid from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Jesse Buie

Seconded by: Ashley Swaffar

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

Xylazine

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable. (30) Xylazine 

(CAS #-7361-61-7)—federal law restricts this drug to use by or on the lawful written or oral order of a 

licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug 

Administration regulations. Also, for use under 7 CFR part 205, the NOP requires: 

NOSB October 2019 proposals and discussion documents Page 215 of 230
(i) Use by or on the lawful written order of a licensed veterinarian, and; 

(ii) A meat withdrawal period of at least 8 days after administering to livestock intended for 

slaughter; and a milk discard period of at least 4 days after administering to dairy animals.

Technical Report: 2002 TAP; 2019 Technical Report

Petition(s): 2002 Petition

Past NOSB Actions: 09/2002 NOSB recommendation; 04/2010 sunset recommendation; 10/2015 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 82 FR 14420; Proposed rule 01/17/2018 (83 FR 2498); Annotation change 12/27/2018 (83 

FR 66559)

Sunset Date: 3/15/22 

Subcommittee Review: 

Background from Subcommittee 

Xylazine is synthesized by reacting 2,6-dimethylphenylisothiocyanate with 3-amino-1-propanol in a polar 

solvent (ether) to form a thiourea. Concentrated hydrochloric acid is added after the solvent is removed. 

Water is added to the cooled mixture which is then filtered, and the filtrate is made basic to form a 

precipitate that is recrystallized as xylazine.

Xylazine is used as a sedative, analgesic, and muscle relaxant in veterinary medicine. As a medical 

treatment, it can be administered intravenously, intramuscularly, subcutaneously, or orally, usually as a 

water based injectable solution. Xylazine can also be found as a white crystalline powder. Xylazine 

sedative properties are due to its depressant mode of action on nervous system synaptic receptors. 

Sedation of animals is necessary for both planned medical procedures and emergency procedures to 

prevent the pain and suffering of animals as well as injury to the veterinarians performing the 

procedures. Xylazine is commonly used in conjunction with tolazoline, which is a reversal agent for 

sedatives such as xylazine.

According to information posted on the FARAD (Food Animal Residue Avoidance Databank) website 

(http://www.farad.org/amduca-law.html; accessed on Aug. 5, 2019), extra label use (i.e., off label use) 

of xylazine is permissible under the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) only

if such use is by or on the lawful written or oral order of a licensed veterinarian within the context of a 

valid veterinarian-client-patient relationship. According to the FARAD Digest (published in JAVMA, Vol. 

223, No. 9, Nov. 1, 2003), xylazine is used in as a medical treatment in livestock intended for food 

production as well as in dairy cows. 

International allowance for use

• Canadian General Standards Board Permitted Substances List

Xylazine is listed in the CAN/CGSB-32.311-2015 — Organic production systems - permitted 

substances list in Table 5.3 “health care products and production aids,” as a “sedative.” 

Tolazoline (most commonly used as a reversal agent for sedatives, including xylazine) is not 

listed in the CAN/CGSB-32.311-2015 — Organic production systems - permitted substances list.

• CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and 

Marketing of Organically Produced Foods (GL 32-1999) 

Neither xylazine nor tolazoline are listed in the CODEX.

NOSB October 2019 proposals and discussion documents Page 216 of 230
• European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

Neither xylazine nor tolazoline are listed in the EEC EC No. 834/2007 or 889/2008.

• Japan Agricultural Standard (JAS) for Organic Production 

Neither xylazine nor tolazoline are listed in the JAS for Organic Production.

• International Federation of Organic Agriculture Movements (IFOAM)

Neither xylazine nor tolazoline are listed in IFOAM.

Persistence/concentration of xylazine or its by-products in the environment. According to the 2019 TR: 

Environmental studies on xylazine ... highlight the possible persistence of the substance and its 

accumulation in soil systems as well as its role as an aquatic pollutant (Fabrega et al. 2013, Choi 

et al. 2014, Pugajeva et al. 2017). Reports of xylazine environmental contamination on the 

Iberian Peninsula may be linked with xylazine manufacturing, resulting in high contributions to 

water pollution in Iberian river systems (Fabrega et al. 2013, Pugajeva et al. 2017). The leaching 

ability of xylazine and its reported slow degradation in aquatic systems make wastewater 

pollution a concern in cases of improper use or disposal (Fabrega et al. 2013, Choi et al. 2014, 

Pugajeva et al. 2017).

Effects on human health. According to the 2019 TR:

Xylazine is a substance with potent hypnotic and muscle-relaxation properties. The side effects 

of xylazine include significant cardiac arrythmias, which has resulted in its lack of approval for 

human medical applications (Green et al. 1981, EMEA 1999, Reyes et al. 2012). Due to the lack 

of approval for use in human medical applications, information on the mode of action and 

toxicity of xylazine is limited.

Reported cases of xylazine in humans have shown physiological effects like those seen in 

veterinary applications (Samanta et al. 1990, JECFA 1998a). Upon absorption of xylazine, 

patients were difficult to rouse and showed signs of confusion (indicative of central nervous 

system and neuropathic depression) and expressed symptoms of bradycardia, hypotension 

(respiratory depression), and hyperglycemia (Gallanosa et al. 1981, Spoerke et al. 1986, Samanta 

et al. 1990).... With regard to human carcinogenicity, no studies of direct effects have been 

published; however, the IARC has designated the xylazine metabolite xylidine as potentially 

carcinogenic to humans based on studies with laboratory animals (NTP 1990, IARC 1993, JECFA 

1998a).

The lethal dosage of xylazine in humans is not well known and appears to vary dramatically 

between individuals (Spoerke et al. 1986, Ruiz-Colon et al. 2014). Fatal doses of xylazine 

recorded have been as low as 40 mg, while other individuals have survived exposure to levels as 

high as 2400 mg (Spoerke et al. 1986, Ruiz-Colon et al. 2014). 

Natural (non-synthetic) alternatives. According to the 2019 TR, “No natural alternatives are common 

for either [xylazine or tolazoline] (i.e., a sedative alternative for xylazine or a xylazine-reversal agent as a 

tolazoline alternative). Moreover, while there are several synthetic alternatives for both substances, no 

other synthetic alternatives have been approved by the USDA for use in organic agricultural 

production.”

NOSB October 2019 proposals and discussion documents Page 217 of 230
Public Comment from the Spring 2019 NOSB Meeting

In written comments submitted for the spring 2019 NOSB meeting, six commenters supported relisting 

xylazine as essential for use in veterinary surgical procedures, and two other commenters noted that 

xylazine was listed on the organic systems plans for operations they certified. No commenters opposed 

relisting. However, one commenter raised two potential issues with xylazine that the commenter 

considered worth investigating further: namely, whether there are alternative practices that could 

replace the need for xylazine, and whether there is an FDA prohibition regarding the use of xylazine in 

the treatment of food-producing animals; however, this commenter did not recommend removal of 

xylazine at this time. 

Subcommittee Vote: 

Motion to remove xylazine from §205.603(a) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA 

Motion by: Dan Seitz

Seconded by: Ashley Swaffar

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

DL-Methionine

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(d) As feed additives. (1) DL-Methionine, DL-Methionine—hydroxy analog, and DLMethionine—hydroxy analog calcium (CAS #'s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)—for use 

only in organic poultry production at the following pounds of synthetic 100 percent methionine per 

ton of feed in the diet, maximum rates as averaged per ton of feed over the life of the flock: Laying 

chickens—2 pounds; broiler chickens—2.5 pounds; turkeys and all other poultry—3 pounds.

Technical Report: 2001 TAP; 2011 TR

Petition(s): 2005 Methionine; 2007 Methionine; 2009 Methionine; 2011 Methionine

Past NOSB Actions: 10/2001 NOSB recommendation; 03/2005 NOSB recommendation; 2008 NOSB 

recommendation; 04/2010 NOSB recommendation on Methionine annotation through October 2012; 

04/2010 NOSB recommendation on Methionine step-down annotation after October 2012; 04/2010 

sunset recommendation; 08/2014 Organic poultry feed proposal; 04/2015 NOSB Formal 

recommendation; 10/2015 sunset recommendation; 

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 82 FR 14420; Proposed rule 01/17/2018 (83 FR 2498); Annotation change 12/27/2018 (83 

FR 66559)

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: Methionine is an essential amino acid for poultry since it cannot be produced biologically by the 

birds and is necessary for proper cell development for the growing chicks and for proper feathering. The 

USDA organic standards, which require all agricultural ingredients for livestock come from an organic 

source, as well as the prohibition of feeding poultry or mammalian by-products to organic poultry or 

mammals, narrow the options for natural sources of methionine. 

Manufacture 

Methionine is a sulfur-containing amino acid. The 2011 technical review lists these various methods of 

manufacture: 

NOSB October 2019 proposals and discussion documents Page 218 of 230
L-methionine may be isolated from naturally-occurring sources, produced from genetically-engineered 

organisms, or synthesized through many processes. While methionine has been produced by 

fermentation in the laboratory, racemic mixtures of D- and L-methionine (i.e., DL-methionine) are usually 

produced entirely by chemical methods (Araki and Ozeki, 1991). Most L-methionine is produced from 

synthetic DL- methionine, and DL-methionine can be produced in following ways: 

• Reaction of acrolein with methyl mercaptan in the presence of a catalyst (Fong et al., 1981); 

• Reaction of propylene, hydrogen sulfide, methane, and ammonia to make the intermediates acrolein, 

methylthiol, and hydrocyanic acid (DeGussa, 1995; 1996);

• Use of the Strecker synthesis method with α-methylthiopropionaldehyde as the aldehyde (Fong et 275 

al., 1981); or 

• Reaction of 3-methylmercaptopropionaldehyde with ammonia, hydrogen cyanide, and carbon dioxide 

in the presence of water in three reaction steps (Geiger et al., 1998). In general, L-methionine is 

produced from DL-methionine via optical resolution resulting in separation into the D- and Lenantiomers (Ajinomoto Corporation, 2012) or by acetylation of synthetic DL-methionine and subsequent 

enzymatic selective deacetylation of the N-acetylated L-methionine (Usuda and Kurahashi, 2010). 

Because much of the DL-methionine supply is synthesized using chemical methods, the L methionine 

produced from it is also synthetic. While nonsynthetic L-methionine can be produced by fermentation, 

there are no commercial sources available that use this method (Kumar and Gomes, 2005).

International 

The European Union does not allow synthetic methionine in livestock feed. EU regulations do allow for 

some use of nonorganic non-GMO agricultural ingredients when organic forms are not available, and 

these ingredients (e.g., nonorganic corn gluten meal) could provide natural methionine. In 2015, there 

was non-organic corn gluten meal available in the United States, and a recent review of the NOP organic 

integrity database noted 12 sources or organic corn gluten meal, with one located in the U.S. and the 

others in China. Canadian standards allow the use of DL-methionine with no restrictions. However, there 

is a notation in the current list of allowed materials under the Canadian Organic Standard, that this use 

of synthetic methionine will be under review in the near future.

Background 

A petition to allow use of this synthetic amino acid in organic poultry rations was presented to the NOSB 

in 1999. In 2001, a Technical Advisory Panel (TAP) analyzed the use of the synthetic DL-methionine and 

determined that feed supplementation with this material is compatible with an organic system of 

agriculture, since it is essential to maintain the health of the birds. Synthetic amino acids are not 

specifically listed as a category of approved synthetics in the Organic Food Production Act. 

For almost two decades this material has been present on the National List of approved synthetics, 

resulting in many written and oral public comments both for and against its allowance in organic poultry 

production. Those against its allowance state synthetic methionine in the poultry ration enables high 

concentrations of organic birds to be raised in confinement, with minimal access to the outdoors. In 

addition, they state that birds who have access to vegetation and bugs on a healthy organic pasture can 

obtain methionine from these sources and do not suffer negative health effects when there is 

insufficient methionine (natural or synthetic) in their ration.

Those in favor of synthetic methionine have stated that natural sources of methionine are difficult to 

provide in sufficient quantities. Crops, such as soybeans, are a source of methionine, but when 

sufficient soybean meal is fed to meet methionine levels, other levels of amino acids become too high 

which results in a poorly balanced ration. Excess protein in the ration causes a significant rise in the 

ammonia levels from manure in the chicken houses, resulting in a lower quality of life for the birds. 

NOSB October 2019 proposals and discussion documents Page 219 of 230
Natural sources of methionine have a variety of issues. There are no organic sources of fish meal, crab 

meal or blood meal. Black soldier larvae would need to be fed in very large quantities, making it 

impractical since there are no sources producing enough dried larvae to feed the current flocks of 

organic poultry in the U.S. Algae is another promising area, but has not been developed to determine its 

acceptability. Items such as whey powder, nonfat dry milk and potato proteins have been tried, but 

were not fully digestible by the birds. These items and more have been researched by the Methionine 

Task Force, an ad-hoc citizen group that has provided information to the NOSB over the years, whose 

members consist of organic poultry operations and animal nutrition specialists.

A final rule published on December 27, 2018, and effective on January 28, 2019, incorporated the NOSB 

recommendation of April 2015 to adjust the amount of methionine in the feed ration to meet the 

demands of the birds at different stages of life, while still limiting the total amount of methionine that 

can be fed over the lifetime of the birds. This change allowed for a specific amount of methionine over 

the life of the bird rather than how much would be allowed per ton of feed prepared for the organic 

flock. Typically, a higher percentage of methionine is needed in the ration when the birds are young and 

growing. Organic poultry producers, through public comment, stated the previous annotation requiring 

a specific amount of methionine in each ration led to poor immune system development, poor 

feathering, feather pecking and cannibalism in their flocks. The new annotation, noted above, effective 

January 28, 2019, will be the listing that the NOSB will vote upon in Fall 2019. The previous annotation 

was as follows:

Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(d) As feed additives. (1) DL-Methionine, DL-Methionine-hydroxy analog, and DLMethionine-hydroxy analog calcium (CAS #'s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9) - for use only 

in organic poultry production at the following maximum levels of synthetic methionine per ton of feed: 

Laying and broiler chickens—2 pounds; turkeys and all other poultry—3 pounds.

In addition to the 2015 NOSB recommendation to modify the annotation for DL-Methionine, the 

following resolution was passed unanimously by the Livestock Subcommittee.

Resolution: The National Organic Standards Board is committed to the phase-out of synthetic methionine 

for organic poultry production, and encourages aggressive industry and independent research on natural 

alternative sources of methionine, breeding poultry that perform well on less methionine, and 

management practices for improved poultry animal welfare.

Public Comment

A short update was received from the “methionine task force” a group of stakeholders working on their

own to find alternatives to synthetic methionine. A few experiments were done in the past few years, 

which did not result in a viable non-synthetic alternative. Natural materials that are high in methionine, 

typically are high in other amino acids as well. When these are added to the poultry ration, the balance 

of amino acids in the ration is inappropriate and causes health and environmental problems for the 

poultry. Excess amino acids can lead to higher ammonia levels in the poultry manure, resulting in high 

ammonia levels in the poultry houses. This organic egg producer group stated they will continue to 

work on this issue. 

Certifiers responded to the change in the DL-methionine annotation and have developed spreadsheets 

for their certified organic poultry operations to use. These spreadsheets can track the current rations to 

meet the new annotation, which requires tracking of methionine fed over the full life of the birds, not by 

each ton of feed.

NOSB October 2019 proposals and discussion documents Page 220 of 230
Some commenters stated that more access to living vegetation would lessen or remove the need for DLmethionine. Organic poultry producers stated they must have DL-methionine for the health and wellbeing of their animals, and pasture access would not provide sufficient quantities of methionine to 

promote healthy and productive flocks.

Subcommittee discussion

The Livestock Subcommittee continues to see a need for synthetic DL-methionine in the organic poultry 

diet. Discussion with the methionine task force on ways to lessen the reliance on this synthetic amino 

acid included blending numerous plant materials instead of just one as the source of methionine to 

achieve a better balance of amino acids, as well as researching natural herbal supplements that might 

enhance the absorption of natural methionine, resulting in less methionine needed in the ration. The 

methionine task force stated they are looking at these options, and they will continue to provide the 

NOSB updates over time.

Subcommittee Vote: 

Motion to remove DL-Methionine, DL-Methionine—hydroxy analog, and DL-Methionine—hydroxy 

analog calcium (CAS #'s 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)—for use only in organic poultry 

production at the following pounds of synthetic 100 percent methionine per ton of feed in the diet, 

maximum rates as averaged per ton of feed over the life of the flock: Laying chickens—2 pounds; broiler 

chickens—2.5 pounds; turkeys and all other poultry—3 pounds from §205.603 of the National List based 

on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Harriet Behar

Seconded by: Ashley Swaffar

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

Trace minerals 

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(d) As feed additives. (2) Trace minerals, used for enrichment or fortification when 

FDA approved.

Technical Report: 2013 TR Aquatic Trace Minerals; 2019 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB recommendation; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 09/2014 aquatic trace minerals subcommittee proposal; 10/2015 sunset 

recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022

Subcommittee Review: 

Information below references the 2019 TR, available at the link above.

Background from Subcommittee 

Use

Minerals are required in animal nutrition for their vital roles in various metabolic, enzymatic, and 

biochemical reactions in the animal body. Forages and grains are good sources of calcium and 

phosphorus, respectively. Minerals may be provided through the intake of plant matter feedstuffs or 

NOSB October 2019 proposals and discussion documents Page 221 of 230
through synthetic supplements. Several factors directly or indirectly influence the levels of minerals in 

plants, including location, nature, and chemical composition of the soil; level of fertilization; and the 

presence of anti-nutritional factors that may reduce mineral bioavailability. Bioavailability is defined as 

the total proportion of the nutrient in a feedstuff that is available for use in normal body functions. As a 

result, the amounts of minerals for animals that depend on plants as feedstuffs will vary. 

The dietary importance of each micro-mineral will depend on the animal species in question. When diet

is insufficient to meet an animal’s nutrient requirements, supplementation of minerals is typically done 

through inclusion in the diet either as an individual substance or as part of a trace mineral premix. NOP 

Guidance 5030 Evaluating Allowed Ingredients and Sources of Vitamins and Minerals For Organic 

Livestock Feed spells out in more detail which minerals are covered under this listing.

It should be noted that while it is beyond the scope of this sunset review to clarify which minerals are 

included in this listing, the Livestock Subcommittee acknowledges this listing also includes macro 

minerals. The 2019 TR addresses macro-minerals that are included in animal diet, though not in great 

detail as they are outside the focus of trace minerals.

Manufacture

Because this is a broad categorical listing, manufacture varies. In most cases, biologically active forms of 

trace minerals cannot be obtained by mining, so many trace minerals used as feed additives are 

produced by chemical reactions resulting in inorganic forms of the mineral. More recently, organic 

forms have become available. This would include the various chelates and complex forms. One of the 

limiting factors to the use of chelated minerals has been high cost. At the time of this review, chelated 

minerals cost 10 to 15 times more per milligram of mineral supplied, compared to inorganic sources.

Descriptions of the common processes used to manufacture many of the trace minerals in us are

included in the 2019 TR. This level of detail is not provided for the class of substances called metal 

amino acid chelates since the processes used to manufacture those materials are largely the same.

International

Canadian General Standards Board (CGSB) Permitted Substance List

CAN/CGSB-32.310, §6.44(c) specifically restricts feeding supplements or additives beyond those 

required for adequate nutrition and health maintenance for the species at each specific stage of life. 

CAN/CGSB-32.311, Table 5.3 includes “Minerals, trace minerals, elements” as substances permitted for 

use in organic livestock production in Canada and allows for “non-synthetic chelated or sulphated 

minerals” including oyster shell, calcium chloride, and magnesium oxide. Synthetic nutrient minerals 

may be used if non-synthetic sources are not commercially available. This annotation does not list all the 

specific minerals allowed; a note in CAN/CGSB-3211*2018, 5.1.2 references Feeds Regulations 1983 as 

the regulatory document to use when assessing mineral supplements to be used in livestock feed. It is 

important to note that chromium and molybdenum are not included in this regulation.

Feeds Regulations 1983 also defines a range of nutrient guarantees for complete feeds for use in the 

exemption of feeds from registration. 

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999) 

The CODEX recommends that “feedstuffs of mineral origin, trace elements, vitamins, or provitamins can 

only be used if they are of natural origin. In case of shortage of these substances, or in exceptional 

circumstances, chemically well-defined analogic substances may be used.” 

NOSB October 2019 proposals and discussion documents Page 222 of 230
European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

Trace minerals, referred to as “trace elements,” are permitted as per article 14 which states that 

“Livestock should be fed on grass, fodder, and feeding stuffs produced in accordance with the rules of 

organic farms ...In addition, in order to provide for basic nutritional requirements of livestock, certain 

minerals, trace elements, and vitamins may need to be used under well-defined conditions.”

Annex VI lists all trace elements approved for inclusion in animal feeds, with the disclaimer that the 

additives must have been approved under Regulations (EC) No 1831/2003. Chromium is not included in 

this list. 

Japan Agricultural Standard (JAS) for Organic Production

The Japan Agricultural Standards (JAS) for Organic Production defines feed additives as “Those specified 

by Article 2.3 of the Law Concerning Safety and Quality of Feeds (Law No. 35 1953).” JAS allows for “feed 

additives” as ingredients in livestock feed “which are natural substances, or those derived from natural 

substances without chemical treat. In case of a difficulty to obtain those feed additives, the use of 

similar agents to describe food additives are permitted only for supplementing nutrition and effective 

compounds in feeds.”

Japanese standards for organic feed also allow the following macro-nutrients – “Limestone, shellfish 

fossils, shells, dolomite, phosphate rock, and diatomaceous earth (all referred to as ‘limestones’) and 

those derived from limestones without chemical treatments. This does not include any chemically 

synthesized substances from calcium carbonate, magnesium carbonate, dicalcium carbonate, tricalcium 

carbonate, magnesium carbonate, dicalcium phosphate, tricalcium phosphate, and silicic acid.”

IFOAM – Organics International 

The IFOAM standards indicate that “organic animal management provides animals with vitamins, trace 

elements and supplements only from natural sources unless they are not available in sufficient quantity 

and/ or quality.”

IFOAM standards also state that “Synthetic vitamins, mineral and supplements may be used when 

natural sources are not available in sufficient quantity and quality.

Human Health and Environment

Based on information presented in the 2019 TR, the hazards associated with the use of the trace 

minerals are primarily associated with dust irritation of the skin and eyes.

When used as petitioned, trace minerals from unconsumed feed have the potential to be transferred to 

ground or surface waters. While trace minerals are essential dietary components for animal feeds, some 

are considered heavy metals with strong toxic potential. When included in animal feeds above required 

amounts, trace elements accumulate in urine and feces. The environmental risks include impairment of 

plant production, accumulation in edible animal products, and contamination of the water supply. In 

addition, there is a correlation between increased trace mineral loads and antimicrobial resistance; as a 

result, trace minerals have upper limits for inclusion. Concerns regarding specific minerals are included 

in the 2019 TR.

Discussion

The NOSB received comments during the first review cycle from a wide representation of the organic 

community supporting the continued use of trace minerals, noting their essentiality to livestock health 

and welfare and their importance in offsetting seasonal variables in forage nutrition. 

NOSB October 2019 proposals and discussion documents Page 223 of 230
Some commenters noted organic production should not be dependent on synthetic nutrients and that 

the current annotation is not restrictive enough to prevent reliance on synthetic materials. These 

commenters recommend adding “when forage and available natural feeds are poor quality” to the 

annotation. Annotations cannot be amended as part of sunset review; should the Subcommittee choose 

to consider amending the annotation, this would need to be added to the work plan.

According to the 2109 TR, forages alone do not satisfy the mineral requirements of grazing cattle. 

Mineral deficiencies and imbalances in grazing ruminants have been reported in almost all regions of the 

world. The choice of forage crop; the part of the plant consumed, and the plant’s state of maturity; the 

soil type and condition; and climatic conditions and seasons when plant material is eaten/gathered are 

all factors in determining the level and availability of trace minerals.

Subcommittee Vote: 

Motion to remove trace minerals from §205.603 of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): NA

Motion by: Scott Rice

Seconded by: Ashley Swaffar

Yes: 0 No: 5 Abstain: 0 Absent: 1 Recuse: 0

Vitamins 

§205.603 Synthetic substances allowed for use in organic livestock production.

Reference: 205.603(d) As feed additives. (3) Vitamins, used for enrichment or fortification when FDA 

approved. 

Technical Report: 2015 TR

Petition(s): N/A 

Past NOSB Actions: 10/1995 NOSB recommendation; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290) ; Renewed 

03/15/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Background from Subcommittee 

The National Organic Program (NOP) currently allows the use of vitamins as feed additives in organic 

livestock production under 7 CFR 205.603, “Synthetic Substances Allowed for Use in Organic Livestock 

Production” for enrichment or fortification when FDA approved in amounts needed for maintenance (7 

CFR §205.237) and for adequate nutrition and health. Further, the USDA organic regulations require 

producers to meet certain standards for livestock health care practices. As part of this requirement, 

livestock feed rations must meet nutritional requirements, including vitamins, minerals, protein and/or 

amino acids, fatty acids, energy sources, and fiber (ruminants) (7 CFR 205.238(a)(2)). 

Depending on the raw nutrients available, vitamins are combined in livestock feed rations of grains, 

beans, oilseeds, and other meals along with minerals and amino acids. There are 15 essential vitamins 

currently allowed for use in organic livestock production for fortification and enrichment: Vitamin A 

(vitamin A acetate), Vitamin B1 (thiamine hydrochloride), Vitamin B2 (riboflavin), Vitamin B3 (niacin, 

NOSB October 2019 proposals and discussion documents Page 224 of 230
nicotinic acid), Vitamin B5 (calcium pantothenate), Vitamin B6 (pyridoxine hydrochloride), Vitamin B7 

(biotin), Vitamin B12 (cyanocobalamin), Vitamin C (ascorbic acid), Choline chloride, Vitamin D3 

(cholecalciferol), Vitamin E (α-Tocopherol acetate), and Inositol. The scope of vitamin compounds is 

reflective of vitamins defined as “required nutrients” by the National Research Council’s (NRC’s) 

Nutrient Requirements for cattle, sheep, swine and poultry. Dietary intake of these essential vitamins is 

essential for the health and well- being of all animals, including livestock. Most vitamins aid in the 

metabolism of proteins, carbohydrates, and fats while some vitamin compounds have important 

antioxidant properties. Common signs of vitamin deficiency include anorexia, poor growth, reduced 

feeding efficiency and, in some cases, mortality. 

Individual vitamin compounds are normally produced on an industrial scale by chemical synthesis or 

partial synthesis. While chemical synthesis remains the dominant industrial production method for 

many vitamins, an increasing number of fermentation processes are being developed for vitamin 

production. Many recently developed fermentation methods for manufacturing vitamins utilize 

genetically engineered microorganisms, generating concerns over the use of these vitamin sources in 

organic food production. The Technical Review conducted in 2015 stated that fermentation production 

using genetic modification may commonly being used in production of vitamins A, B2, B5, B6, C, E, and 

B12. Selection of the manufacturing processes typically depends on available technology, cost of raw 

materials/chemical feedstocks, market prices and size, cost of implementing fermentation versus 

chemical processes (synthesis or extraction) and, to a lesser extent, the overall environmental impact of 

the production method. 

In response to the TR information, NOP dispersed Guidance 5030 “Guidance Evaluating Allowed 

Ingredients and Sources of Vitamins and Minerals For Organic Livestock Feed” which instructs certifiers 

to be diligent when reviewing vitamins for the presence of excluded methods. Specific to excluded 

methods in vitamins, NOP wrote, "The USDA organic regulations also prohibit use of excluded methods 

at § 205.105(e), and thus vitamins used in livestock feed should be reviewed for excluded methods." 

https://www.ams.usda.gov/sites/default/files/media/5030.pdf. OMRI acknowledged that vitamins may 

be produced using excluded methods in their Generic List and published a Decision Tree For Evaluation 

of GMO Inputs in Organic Livestock Production on page 85 of their Generic List. 

http://www.omri.org/sites/default/files/app_materials/OMRI-GML-Stan-2013small_0.pdf

The addition of vitamins directly or indirectly into animal food falls under the regulatory oversight of the 

U.S. Food and Drug Administration (FDA). According to FDA regulations, the addition of vitamins must 

be used according to the relevant food additive regulation, unless the substance is generally recognized 

as safe (GRAS) under 21 CFR 582/584 for that use pattern (FDA, 2014a).

Environmental Impact

No studies have been found indicating toxic effects of vitamins on soil-dwelling organisms. Strong acids 

and bases are used in the synthetic or extraction process of vitamin compounds. Improper use or 

disposal of these chemicals during the production of vitamins could affect both the pH and chemical 

composition of the soil, potentially resulting in physiological effects on soil organisms. Accidental release 

of chemical reagents during the production process may lead to ecological impairment. Aquatic 

ecosystems are particularly sensitive to the introduction of nutrients from nearby agricultural 

operations. Releasing excessive amount of agricultural materials—including phosphate and nitrate 

fertilizers, feed materials and manure—to waterways can encourage the growth of algae (algal bloom) 

and other aquatic plants and ultimately oxygen depletion in the affected water zone (Wu, 1995; NAS, 

1969).

Heath Impact

In addition to being essential nutrients, vitamins are generally considered non-toxic and safe for 

livestock and human consumption at levels typically ingested through the diet and dietary supplements. 

NOSB October 2019 proposals and discussion documents Page 225 of 230
When given according to label directions, supplementation of animal feeds with vitamins is unlikely to 

result in excessive vitamin intake for humans. 

International

The Canadian National Standards Board, the Codex Alimentarius Commission, the EU and the Japanese 

organic standards all prohibit the use of synthetic vitamins when natural sources are available. If natural 

sources are not available, synthetic forms of vitamins are allowed. The United Kingdom Soil Association 

adds additional stipulation that the producer to must demonstrate nutritional deficiency of the animals’ 

feed.

Public Comments

During the Spring 2019 NOSB review the Livestock Subcommittee received limited comments on 

retaining vitamins at §205.603. The comments that were received were overwhelmingly favorable 

comments for relisting Vitamins to §205.603 (d)(3), with many of the commenters stating that the 

addition of vitamins to the livestock diet was essential for the health and well-being of the animal. 

A commenter stated that livestock feed should rarely need supplementation with synthetic vitamins, 

and then the only synthetic vitamins that may be needed on a limited basis would be vitamins A, C, and 

D. They detailed that B6 vitamins are naturally produced in the rumens of ruminant livestock and could 

naturally be added to the diets of pork and poultry by adding meats, rice bran, molasses, potatoes, 

wheat germ, pistachio nuts, cottonseed, brown rice, amaranth grain, chickpeas, sesame seeds, beans, 

sunflower seeds, barley malt flour, soy flour, corn, Japanese chestnuts, whey protein powder into the 

livestock rations. 

In regard to this comment, we must comply with §205.237 (b)(5) which states that it is prohibited to 

“Feed mammalian or poultry slaughter by-products to mammals or poultry.” which would eliminate the 

addition of meats or whey protein powders to the rations. Many of the above natural sources cited as 

good sources for the B Vitamins are not commonly used in livestock rations and may not be readily 

available for livestock feedstock. During the Spring 2015 sunset review, the NOSB received several 

written public comments indicating overwhelming support for retaining synthetic vitamins on the NL. 

The use of green forages and pastures are alternatives; however, concerns were expressed regarding 

the availability of enough year-round quantity of forages and other. The Subcommittee would like 

comments from stakeholders to determine the availability of feedstocks to naturally supply the B 

vitamins. 

Vitamins are recommended for relisting to the National List, based on the 2015 Tap Review, the 2015 

NOSB unanimous vote to add vitamins to the National List, and the lack of new scientific or meritorious 

information. 

Questions 

Are there sufficient year-round supplies of forages and livestock feedstocks available to naturally supply 

the B vitamins into the livestock rations, or should B vitamins be removed from §205.603? 

Subcommittee Vote:

Motion to remove vitamins from §205.603(d)(3) based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: NA

Motion by: Sue Baird

Seconded by: Ashley Swaffar

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

NOSB October 2019 proposals and discussion documents Page 226 of 230
National Organic Standards Board

Livestock Subcommittee

Petitioned Material Discussion Document

Fenbendazole

August 16, 2019

Summary of Petition:

A petition requesting a revision to the annotation for Fenbendazole to expand the use to poultry. This 

petition requests an annotation to 7 CFR §205.603(a)(23)(i) to include laying hens and replacement 

chickens intended to become laying hens.

Background of Current Listing:

In May 2012, fenbendazole was added to the National List of organic materials for use in organic 

livestock, as specified in 7 CFR §205.603(a): 

Parasiticides—Prohibited in slaughter stock, allowed in emergency treatment for dairy and 

breeder stock when organic system plan-approved preventive management does not prevent 

infestation. Milk or milk products from a treated animal cannot be labeled as provided for in 

subpart D of this part for 90 days following treatment. In breeder stock, treatment cannot occur 

during the last third of gestation if the progeny will be sold as organic and must not be used 

during the lactation period for breeding stock. 

(i) Fenbendazole (CAS #43210-67-9)—only for use by or on the lawful written order of a licensed 

veterinarian.

In 2016 the NOSB recommended that the annotation for Fenbendazole be amended to include the 

following:

• That parasiticides continue to be prohibited in slaughter stock.

• That the milk withholding period after treatment with fenbendazole be changed from 90 

days to 2 days for dairy cows, and 36 days for goats and sheep.

• That fleece and wool from fiber bearing animals be allowed to be certified organic even if 

use of parasiticides was necessary at some time in the animal’s life.

• That fenbendazole be allowed without written order of a veterinarian.

The NOP issued a final rule with an effective date of January 28, 2019, with the following language:

Paragraph (a)(23)(i) is revised to read as follows: Fenbendazole (CAS #43210-67-9)—milk or milk 

products from a treated animal cannot be labeled as provided for in subpart D of this part for: 2 

days following treatment of cattle; 36 days following treatment of goats, sheep and other dairy 

species. AMS has reviewed and agrees with the NOSB recommendation that the annotation for 

fenbendazole be amended to clarify its use in organic livestock production.

In addition, paragraph (b)(2) of § 205.238(b) is revised and paragraph (b)(3) is added to 

§ 205.238(b) as follows: (b)(2) Dairy animals, as allowed under § 205.603; and (b)(3) fiber 

bearing animals, as allowed under § 205.603. AMS has reviewed and agrees with the NOSB 

recommendation that § 205.238(b) be amended to clarify its use of parasiticides for dairy 

animals and for fiber bearing animals.

NOSB October 2019 proposals and discussion documents Page 227 of 230
In the Spring of 2018 the NOSB recommended clarifying “emergency” for use of synthetic parasiticides 

in organic livestock production. The following language was recommended for a rule change:

Add this definition to 205.2

Emergency treatment to allow synthetic parasiticide use in livestock: A livestock emergency is an 

urgent, non-routine situation in which the organic system plan’s preventive measures and 

veterinary biologics are proven, by laboratory analysis or visual inspection, to be inadequate to 

prevent life-threatening illness or to alleviate pain and suffering. In such cases, a producer must 

administer the emergency treatment (§205.238(c)(7)). Organic certification will be retained, 

provided that such treatments are allowed under § 205.603 and the organic system plan is 

changed to prevent a similar livestock emergency in individual animals or the whole herd/flock in 

future years as required under §205.238(a).

Add this to § 205.238 (b)

(4) Organic livestock as provided in §205.238 (b) (1), (2), and (3) and only in the event of an 

emergency where management strategies have been proven insufficient to prevent or control 

parasites within the accepted threshold for specific parasites, age and species of the animal. 

These management strategies include but are not limited to, grazing systems and living 

conditions that prevent infestation and re-infestation, forage height diversity, use of allowed 

non-synthetic botanicals, biologics and minerals to maintain parasite levels below treatment 

thresholds, and could include monitoring and documentation of parasites through use of 

methods such as fecal monitoring and FAMACHA.

This NOSB recommendation is still pending NOP review.

Summary of Review:

The Livestock Subcommittee reviewed the petition seeking to add an annotation to fenbendazole to 

expand its use in laying hens and replacement chickens intended to become laying hens. The 

Subcommittee did not feel the need to request an update technical report (TR) on Fenbendazole since a 

TR was conducted in June 2015.

Many organic laying hens have meaningful direct access to the soil, and this is one area where birds that 

are truly out grazing the land are at a disadvantage compared to birds on concrete porches. With the 

shifting demand for eggs from hens with humane certifications such as Free Range or Pasture Raised 

production models requiring 2.0-108.9 square feet per bird of outdoor access, many laying hen flocks 

are seeing large internal parasite infestations. When birds are out grazing, they are scratching and 

digging in the dirt for worms and in return picking up intestinal parasites. When a chicken has intestinal 

parasites some of the issues include having lower feed absorption, increased mortality, parasite 

transmission into the egg, and disease transmission to the hens. 

Currently poultry producers sometimes use a diatomaceous earth product to help control intestinal 

worms. There are several concerns with this product including the amount needed to be ingested in 

relation to daily feed intake (non-balanced diets), worker and animal health hazards when using 

diatomaceous earth (respiratory concerns), and lack of efficacy to control severe parasite infestations.

If fenbendazole is added to the national list for laying hens and replacement chickens, it would be 

allowed only for emergency treatment when organic system plan-approved preventive management 

does not prevent infestation. Producers and certifiers would need to work together to define what an 

NOSB October 2019 proposals and discussion documents Page 228 of 230
emergency is for each producer. Examples include the discovery of internal parasites during routine 

posting or autopsy sessions of flocks, and/or observation of parasites in manure droppings. The 

Subcommittee feels strongly that fenbendazole should be used only in emergency situations and not on 

a routine basis.

Even though the current listing for fenbendazole for cattle, sheep, goats, and other dairy species

specifies withdrawal times, the Subcommittee does not intend to restrict the use of fenbendazole on 

poultry by specifying a withdrawal time. The FDA reviewed fenbendazole’s use as an approved animal 

drug and determined that it did not require a withdrawal time for poultry. “The data in study #S12173-

00-DWF-MET-PO show that total residues of fenbendazole in eggs of treated chickens at zero-day 

withdrawal are well below the safe concentration of 2.4 ppm for residues in eggs.”1

 

Use of the Substance:

• 200 mg of fenbendazole/ml for oral administration via drinking water

• Safe-Guard® AquaSol must be administered orally to chickens via the drinking water at a daily 

dose of 1.0 mg/kg BW (0.454 mg/lb.) for 5 consecutive days.

Conventional poultry producers typically administer fenbendazole to pullets (replacement layers age 0-

17 weeks of age) or before outdoor access is given to birds to ensure birds have no internal parasites

before starting egg production. When birds receive access to the outdoors they come into contact with 

soil and in turn come into contact with internal parasites. Many producers find the need to re-treat

their flocks after a period of time when birds have access to the soil and come into contact with many 

internal parasites. Organic producers will need to utilize preventative management practices defined in 

their Organic System Plan as a first line of defense for internal parasites and if those preventative 

practices fail, an emergency treatment of fenbendazole could be used to control internal parasites. 

Mode of Action: 

Fenbendazole binds to β-tubulin, inhibiting assembly of microtubules, resulting in cell and parasite 

death. According to the Merck Veterinary Manual, “The wide safety margin of benzimidazoles is due to 

their greater selective affinity for parasitic β-tubulin than for mammalian tissues.” (Merck, 2006)

Questions:

1. Is this material needed by organic poultry producers? If so, why?

2. Do currently allowed alternatives work to control internal parasites? And at what level of 

effectiveness? 

3. What are some of the “emergency” events that would trigger use of this product? And how would 

producers determine those events? 

4. Is there a concern with the 2.4 ppm residue of fenbendazole in eggs? Please submit information that 

supports this concern, or lack of concern.

1 https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/3083

NOSB October 2019 proposals and discussion documents Page 229 of 230
Subcommittee Vote:

Motion to accept the fenbendazole petitioned-material discussion document

Motion by: Ashley Swaffar

Seconded by: Sue Baird

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

NOSB October 2019 proposals and discussion documents Page 230 of 230