National Organic Standards Board | November 2016| Proposals & Discussion Documents

TOC 1

National Organic Standards Board Meeting

Chase Park Plaza, St. Louis, MO

November 16-18, 2016

Title Page

Compliance, Accreditation, & Certification Subcommittee (CACS) | Carmela Beck, Chairperson

Discussion document: Personnel Performance Evaluations of Inspectors (NOP 2027) 1

Verbal Update: Eliminating the incentive to convert native ecosystems into organic 

crop production

No 

document

Handling Subcommittee (HS) | Harold Austin, Chairperson

2018 Sunset Reviews: Agar-agar, Animal enzymes, Calcium sulfate-mined, 

Carrageenan, Glucono delta-lactone, Tartaric acid, Cellulose, Potassium hydroxide, 

Silicon dioxide, Colors: Beta-carotene extract

5

Proposal: Sodium Chlorite for the generation of chlorine dioxide gas - petitioned 31

Proposal: Oat protein concentrate - petitioned 37

Proposal: Tocopherols - additional listing 43

Proposal: Tocopherols - annotation change 45

Discussion document: Cumulative impact of phosphates in organic processed foods 47

Discussion document: Marine algae listings on National List 55

Update: Xanthan gum reclassification 63

Materials Subcommittee (MS) | Lisa de Lima, Chairperson 

Proposal: Fall 2016 Research Priorities 65

Proposal: Excluded methods terminology 75

Discussion Document: Excluded methods terminology 85

Report to the USDA Secretary on progress to prevent GMO incursion into organic 89
TOC 2

Crops Subcommittee (CS) | Zea Sonnabend, Chairperson 

2018 Sunset Reviews: Copper sulfate, Ozone gas, Peracetic acid, EPA List 3 - Inerts 

of unknown toxicity, Calcium chloride

93

Discussion document: Strengthen and clarify the requirements for use of organic 

seed (NOP 5029)

103

Proposal: Aluminum sulfate - petitioned 107

Proposal: Soy wax - petitioned 117

Proposal: 1-methylcyclopropene (1-MCP) - petitioned 121

Proposal: Ammonium citrate 125

Proposal: Ammonium glycinate 129

Proposal: Potassium cellulose glycolate 133

Proposal: Hydroponics (Bioponics) 137

Discussion document: Container and greenhouse production - further clarifications 147

Policy Development (PDS) | Tom Chapman, Chairperson

Proposal: Policy and procedure manual (PPM) updates 157

Proposal: Sunset Review - Efficient work load reorganization 237

Livestock Subcommittee (LS) | Ashley Swaffar, Chairperson 

Proposal: Ivermectin removal - petitioned 245

Proposal: Aluminum sulfate - petitioned 253

Proposal: Sodium bisulfate - petitioned 263

Proposal: Acid-activated bentonite - petitioned 273
National Organic Standards Board

Certification and Accreditation Subcommittee (CACS) Discussion Document

Personnel Performance Evaluations of Inspectors

September 14, 2016

I INTRODUCTION

Over the last year and a half certifiers have been working to meet the requirements of NOP 2027, 

Instruction: Personnel Performance Evaluations, promulgated by the NOP on August 2, 2013 and revised 

effective March 31 2016. This Instruction appears to require that every inspector should be evaluated in 

the field every year. Many certifiers have expressed considerable concern for the logistics and expense 

of meeting this Instruction and the potential negative impact it will have on the organic community over 

time. 

This Discussion Document seeks to provide an opportunity for stakeholders to respond to the NOSB 

request for further public comment on this issue.

II BACKGROUND

On December 2, 2011 the NOSB voted 13:1 with 1 abstention to “provide all inspectors with 

performance assessment and oversight: a. Witness audits by ACA to be conducted at a minimum every 

300 inspections or 3 years whichever is less. Results must be documented. Witness audits may be 

conducted by certification management, senior inspectors or senior reviewers.” 

On August 2, 2013 the NOP issued Instruction 2027 requiring in-field evaluations “at least annually.”

In 2014 the International Organic Inspectors Association (IOIA) explored a pilot program to assist 

certifiers in developing and managing an in-field inspector evaluation program. IOIA developed an 

evaluation form, recruited evaluators and in consultation with several certifiers, implemented a fee for 

service program in 2015. In 2016, IOIA expanded this program. 

On September 4, 2015 the Accredited Certifiers Association (ACA) submitted a letter to the NOP

providing some observations and concerns about the impact of this Instruction and provided several 

recommendations for improving this requirement. ACA referenced the 2011 NOSB recommendation and 

requested Instruction 2027 be amended to permit certifiers to develop risk-based plans to evaluate the 

inspectors they work with across a rotational cycle and not limited to one calendar year. ACA also 

requested certifiers be permitted to shared evaluations.

On December 8, 2015 the NOP issued NOP 2501 Evaluating Auditor Performance (of NOP Auditors), 

which requires in-field evaluation every 3 years. “5.2b A Witness Appraisal shall be conducted at least 

once every 3 years.” 

On February 15, 2016 the IOIA submitted a Report to the NOP on the pilot in-field evaluation program. 

In response to concerns about implementation of the in-field evaluation of every inspector world wide 

every year, the NOP revised NOP 2027 effective March 31, 2016 to include a provision, at 3.2 b ii, that 

“Certifiers may use the field evaluations of another accredited certifier. The revised Instruction at, 3.2 b 

iii, also included a provision that “Certifiers may submit alternative proposals for field evaluation to their 

Accreditation Manager.” 

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During spring and summer 2016 the IOIA reports that they are working with 10 certifiers to provide infield evaluations of 106 inspectors.

III RELEVANT AREAS OF THE RULE

USDA Organic Regulations (7 CFR Part 205) § 205.501 General requirements for accreditation. 

(a) A private or governmental entity accredited as a certifying agent under this subpart must: ... 

(6) Conduct an annual performance evaluation of all persons who review applications for 

certification, perform on-site inspections, review certification documents, evaluate 

qualifications for certification, make recommendations concerning certification, or make 

certification decisions and implement measures to correct any deficiencies in certification 

services.

IV DISCUSSION

In response to public comment in spring 2016 the CACS reached out to both NOP staff and certifiers to 

better understand how NOP 2027 was impacting the certification process. 

Stakeholders agree that all inspectors must be professionally evaluated every year. Indeed, inspectors 

are professionally evaluated on a regular basis via review of their inspection reports and anecdotal and 

statistical feedback from certified operations. Stakeholders agree that in-field evaluations must take 

place, but many certifiers disagree about the requirement of an in-field evaluation of every inspector 

every year, worldwide. This disagreement is based primarily on logistics but also cost. 

The NOP expressed considerable concern about the quality of work of some inspectors that the NOP 

auditors had witnessed during mid-term or 5 year review of some certifiers in recent years. The NOP 

interprets §205.501 to require in-field evaluation of every inspector world wide every year, and that this 

is necessary to ensure consistency in organic certification.

The ACA provided feedback from a range of certifiers. For some state-run certifiers the annual in-field 

inspections do not appear to be a serious concern either logistically or financially. Some certifiers see 

this requirement as beneficial in encouraging inspectors to increase their ongoing education.

For many other certifiers however, large and small, considerable concern has been raised regarding

costs, logistics, inequities between certifiers and a range of other issues. Below are some comments and 

feedback encapsulated from outreach with stakeholders. 

• It's unclear if NOP will approve alternative plans but certifiers would appreciate the option.

• Evaluating an inspector used only a few times a year is not feasible. 

• Some certifiers are already relying heavily on shared evaluations and offering them to other 

certifiers at no charge. Others are trading evaluations or charging a fee.

• The most expensive evaluations are those in remote areas since the remote location is often the 

reason a certifier is using an outside inspector.

• Many certifiers believe strongly that in-field evaluations are a positive for their organization and 

the industry. Conducting them internally carries a high value. Evaluations received from other 

sources vary in quality and do not cover adherence to a certifier’s own policies, nor do they 

present an opportunity to observe personal, interactive skills essential to good inspections. 

However, some find the cost-benefit just doesn't work out for every inspector every year. A risk2/279
based approach would be more effective and efficient at achieving the desired results. 

• Some certifiers have seen a number of new applicants and have had to find new inspectors, or

certifiers have had to turn to more inspectors than planned late in the year. This presents an 

even greater workload to ensure these inspectors are evaluated. The logistics and entire process 

is time consuming for all involved and presents difficulties and disincentives. 

There are reasonable arguments for enforcing this in-field evaluation of every inspector world wide 

every year, and reasonable arguments for allowing flexibility in how certifiers meet the intent of 

205.501.

The implementation of the IOIA field evaluation is only in its second year, and time will tell if the 

programs in place now will be sustainable over time without loss of inspectors or increased fees to 

clients at a time when there is increasing demand for certification of operations worldwide.

V REQUEST FOR PUBLIC COMMENT

The NOSB seeks public comment from certifiers, providers of evaluation services such as IOIA, individual 

inspectors, and organic producers about the requirement of every inspector being evaluated in the field 

every year:

1. For certifiers: To date, what have you observed about the benefits, costs and logistics of 

meeting this requirement?

2. For certifiers: Have you been able to meet this requirement for inspectors in overseas locations?

3. For certifiers: If given an option to present alternative evaluation plans to the every inspector, 

every year, what would these look like? If a risk-based approach, how do you define risk?

4. For certifiers and inspectors: What has been your experience sharing evaluation forms and 

processes? What have been the challenges associated with this sharing?

5. For inspectors: To date, what are the concerns and benefits that you have observed? 

6. For organic operators: To date, what are the concerns and benefits that you have observed or 

experienced during in-field audits conducted on your operation?

7. For all stakeholders: What mechanisms are in place to ensure that client files being shared 

between evaluators and inspectors are taking place on completely secure computer systems?

8. For all stakeholders: What are the in-field audit requirements for auditors of other inspection or

certification schemes such as GFSI, Global GAP, SQF etc.?

Motion to approve the discussion document for posting for the fall 2016 NOSB meeting

Motion by: Scott Rice

Seconded by: Harriet Behar

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

Approved by Carmela Beck, Subcommittee Chair, to transmit to NOSB September 14, 2016

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Sunset 2018 Review Summary 

Meeting 2 – Subcommittee Review

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

November 2016 

As part of the National List Sunset Review process, the NOSB Handling Subcommittee has evaluated the 

need for the continued allowance for or prohibition of the following substances for use in organic 

handling.

Reference: 7 CFR 205.605(a) Nonagricultural (Nonorganic) substances allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food 

group(s)).’’

(Linked below)

Agar-agar

Animal enzymes

Calcium sulfate-mined

Carrageenan

Glucono delta-lactone

Tartaric acid

Reference: 7 CFR 205.605(b) Nonagricultural (Nonorganic) substances allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food 

group(s)).’’

Cellulose

Potassium hydroxide

Silicon dioxide

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

on processed products labeled as “organic.”

(d) Colors derived from agricultural products - Must not be produced using synthetic solvents and carrier 

systems or any artificial preservative.

(2) Beta-carotene extract color

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Agar-agar

Reference: §205.605(a)

Technical Report: 1995 TAP; 2011 TR

Petition(s): NA

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

Use: 

Agar-agar has been used as a food additive for over 350 years. Current uses in food include: stabilizer, 

thickener, gelling agent, texturizer, moisturizer, emulsifier, flavor enhancer, and absorbent. It can be 

found in bakery products, confections, jellies and jams, dairy products, canned meat and fish products, 

and vegetarian meat substitutes. Useful characteristic of agar-agar include that it can withstand high 

temperatures, and since it is practically tasteless and doesn’t require the addition of cations to form 

gels, it doesn’t interfere with taste profiles. It can be used in foods in combination with other thickening 

or gelling agents. It is classified as GRAS. 

Manufacture: 

Agar-agar is derived from red algae, the main species harvested are Gelidium and Gracilaria, the second 

of which can be cultivated. After harvesting, the algae are cleaned with water, dried in the sun, pressed 

into bales and shipped to processors for agar-agar extraction. Prior to extraction the Graciliara species 

are usually subjected to alkaline pretreatment (heated in a sodium hydroxide solution) followed by 

rinsing with water and sometimes a weak acid to neutralize the alkali. Alkaline pretreatment is used to 

bring about a chemical change in the polysaccharides. This chemical change produces agar-agar with 

increased gel strength. Without this pretreatment, the gels extracted from Graciliara species would be 

too weak for most food applications. (TR 2011, 165-176) 

After pretreatment, the algae are placed in tanks for the extraction via hot water pressure, and then 

filtration. The last step is to remove water from the gel either through a freeze thaw process or by 

mechanical pressure. The gels are then dried with hot air resulting in a finished product of flakes, strips, 

or powder. 

Based on this manufacturing information, the Handling Subcommittee acknowledges that a 

reclassification of agar-agar might be needed in the future once the NOP finalizes the Guidance for 

Material Classification. 

International: 

Agar-agar is not permitted for use in organic production in Japan. It is permitted for use in organic 

production by CODEX, the Commission of the European Communities, IFOAM, and Canada. 

Discussion: 

The 2011 TR did not find the substance to be harmful to human health, additionally the report stated 

that no excessive levels of heavy metals or other contaminants have been reported in agar-agar. 

With regard to harm to the environment or biodiversity, the TR stated there is limited evidence to 

suggest that the harvesting of agarophytes (algae used to make agar-agar) may be harmful to 

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biodiversity. Additionally, harvesting wild agarophytes may also reduce biodiversity on nearby beaches. 

The TR concludes though that no studies were found to indicate whether or the not the harvesting of 

agarophytes in particular is harmful to biodiversity on nearby beaches or in the algae beds themselves 

(TR 2011 296-312). 

The NOSB is in the process of reviewing the use of all marine plants currently on the National List and a 

limited technical report has been requested. The marine plants topic will be reported on as a separate 

item at the Fall 2016 meeting. 

A variety of organizations and manufacturers commented in support of keeping agar-agar on the 

National List. There were no commenters opposed. Two organizations commented that they would 

support relisting of the non-synthetic form only. A proposed annotation was “from Gelidium species 

only, processed without alkaline treatment and sourced from areas managed for sustainability”. 

At the first posting for agar-agar, the Handling Subcommittee asked the public for input on any new 

developments with alternatives to agar-agar, why it’s used instead of alternatives, and what the unique 

characteristics are that make it essential to organic handling? Responses included: since there is no 

source for organic gelatin, agar-agar is essential for the manufacture of gummy products because it is 

superior to using carrageenan and gellan gum; it is used as a stabilizer and the alternative is 

carrageenan; it is used as thickener in soy cheese and no suitable alternatives have been found; it has 

stronger setting properties than animal based gelatins; it is less temperature sensitive than certain 

alternatives. 

The Handling Subcommittee proposes that agar-agar remain on the National List

Additional Information Requested:

Based on information reviewed, the Subcommittee is not aware of any ancillary substances used in 

agar-agar. If the public is aware of any ancillaries please provide information via public comment.

Motion to Remove 

The Subcommittee proposes removal of agar-gar from the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Vote in Subcommittee

Motion by: Lisa de Lima

Seconded by: Ashely Swaffar

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

Animal enzymes

Reference: §205.605(a) Animal enzymes - (Rennet - animals derived; Catalase - bovine liver; Animal 

lipase; Pancreatin; Pepsin; and Trypsin).

Technical Report: 2000 TAP, 2011 TR, 2015 TR

Petition(s): NA

Past NOSB Actions: 11/2000 meeting minutes and vote; 11/2007 recommendation; 12/2011 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

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Subcommittee Review

Use: 

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

142)

Animal enzymes, such as rennet, are used as a coagulant to curdle milk, to be made into cheese or sour 

cream. Enzymes are used in very small amounts to achieve the desired effect. For example, the amount 

of animal-derived rennet used to clot milk is 0.036 percent. (TR 2011 727-728)

Manufacture: 

Traditionally the fourth stomach or other organs of goat kids or calves are dried, cleaned, and then 

sliced into pieces, before being stored in either whey or saltwater. Vinegar or wine can be added to 

lower the pH. After allowing the solution to sit for a few days, it is filtered repeatedly. A small amount of 

boric acid is added to the filtrate. In industrial production the stomach is minced and the pH adjusted by 

adding hydrochloric acid and sodium phosphate. (TR 2011 444-458)

International: 

The use of enzymes is permitted in organic processing in Canada, CODEX, EU, IFOAM, and Japan. 

Ancillary substances: 

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. 

 

Additional Information Requested:

1). During the 2017 sunset review of enzymes (non-animal) the following chart was posted and the 

public submitted additional ancillary substances (now included in the chart). If you know of ancillary 

substances used in animal enzymes that are not found on the chart below, please submit spec sheets 

or names of materials. If there are ancillary substances on the chart that you think should not be 

allowed, please submit public comment explaining why. 

 

2). “Mineral oils, untreated or mildly treated” are on the combined IARC/NTP list. The latest technical

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evaluation report (TR) (March 12, 2015) for mineral oil that was done for the Livestock 

Subcommittee states that for refined mineral oil, the refining process removes the materials that 

pose the carcinogen concerns. It also mentions that according to the FDA database for “Everything 

Added to Food in the United States” (EAFUS), mineral oils are approved for use as direct, secondary 

direct, and indirect food additives for human and animal feed (FDA, 2014). FDA permits the direct 

addition of mineral oil to food for consumption under 21 CFR 172.842 and 172.878. Could you 

provide the committee with any information as to how prevalent or necessary mineral oil is as an 

ancillary for animal enzymes? Also, could you provide us with any information as to the type of 

mineral oil currently being used? For example: refined, mildly treated, or untreated mineral oil?

Ancillary Substances by Food Additive Functional Class

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

stearate, magnesium silicate/talc, magnesium sulfate, sodium 

al minosilicate Carriers and fillers Lactose, maltodextrins, sucrose, dextrose, potato starch, non-GMO 

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

autolyzed yeast, inulin, cornstarch, sucrose, glycerol, potassium 

chloride, ammonium sulfate, 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, purity gum (starch), saccharose, 

sorbitol, soy flour, sunflower oil, trehalose, vegetable oil, microcrystalline cellulose, propylene glycol, stearic acid, dicalcium 

phosphate,

Preservatives Sodium benzoate, potassium sorbate, ascorbic acid, 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 acid, trisodium citrate, zinc sulfate.

Stabilizers Maltodextrin, betaine (trimethylglycine), glucose, glycerol, sodium 

chloride, sodium phytate, sorbitol, sucrose. 

pH control, buffers Acetic acid, citric acid anhydrous, sodium citrate, sodium 

phosphate, trisodium citrate. 

Discussion: 

Evaluation question #9 in 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. 

Evaluation question #10 in the 2011 TR does not find significant effects upon human health. Enzymes 

can remain active after they are digested and, as proteins, can cause allergic reactions in sensitive 

individuals (Tucker and Woods, 1995). FDA reports it is not aware of any allergic reactions associate with 

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the ingestion of food containing enzymes commonly used in food processing (FDA, 1995). (TR 2011 752-

758). 

There are no true alternatives to animal enzymes. Enzymes can only be substituted with another 

enzyme with the same function. One alternative to animal derived rennet for the production of cheese 

is genetically engineered chymosin, which is incompatible with organic food handling due to the use of

excluded methods to produce it. 

The 2000 TAP review for animal derived enzymes indicated that animal derived enzymes could be 

produced from organic livestock. 

Public comment during the first posting included a number of producers in favor of animal enzymes 

remaining on the National List. Multiple commenters stated it was essential for making certain varieties 

of cheeses and that organically derived animal enzymes were not available. Multiple organizations 

commented that organic alternatives should be explored more fully; if not currently available the 

barriers should be identified as well as how to overcome them. One organization felt animal enzymes 

were probably not essential since the majority of enzymes of used in the U.S. were non-animal. 

The Handling Subcommittee proposes that animal enzymes remain on the National List

Motion to Remove 

The Subcommittee proposes removal of animal enzymes - (Rennet - animals derived; Catalase - bovine 

liver; Animal lipase; Pancreatin; Pepsin; and Trypsin) from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Vote in Subcommittee

Motion by: Lisa de Lima

Seconded by: Ashley Swaffar

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

Calcium sulfate-mined

Reference: §205.605(a)

Technical Report: 1996 TAP, 2001 TAP

Petition(s): 2000 

Past NOSB Actions: 09/1996 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review: 

Uses: 

• Coagulate in tofu manufacturing. Calcium sulfate is essential to soft and silky tofu types.

• Yeast food and dough conditioner, water conditioner

• Firming agent (in canned foods)

• Jelling ingredient

• Baking powder

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• Sequestrant, filler, carrier, pH buffer, abrasive agent

• Cosmetics and toothpaste

Manufacture:

Calcium Sulfate can be obtained from natural sources or synthetic sources. The listing restricts calcium 

sulfate to mined sources and mined gypsum is the primary source. After mining crude gypsum, it is 

ground and separated. It is normally sold in pure form but may contain impurities of calcium carbonate 

and natural occurring silica. The material is GRAS. 

International: 

IFOAM – restricted “For soybean products, confectionery and in bakers’ yeast” but not restricted to 

mined sources. CODEX – restricted to “Cakes & biscuits/soy bean products/baker’s yeast. Carrier” but 

not restricted to mined sources. Japan – restricted to” Limited to be used as coagulating agent or used 

for confectionary, the processed beans products or bread yeast” but not restricted to mined sources. 

Canada – restricted to “as a carrier for cakes and biscuits; for soybean products; and for bakers’ yeast” 

and source is restricted to “sulfates produced using sulfuric acid are prohibited.” EU - restricted to use 

as a coagulation agent and carrier only but is not restricted to mined sources. Mexico – restricted to 

acidifiers, acidity, anti-caking agent, antifoam, filler and coagulant but not restricted to mined sources. 

Ancillary substances: None reported in 2001 TAP 

Discussion:

Several comments were received on this substance. Manufacturers and Trade Associations emphasized 

its use in tofu production. Several companies noted it was critical to production of tofu and soy cheese. 

One manufacturer noted they would like it retained but they currently use magnesium chloride instead. 

Another manufacturer noted magnesium chloride produced a softer tofu than calcium sulfate. It was 

also noted that calcium sulfate was used in the brewing industry to adjust the mineral content of water. 

One interest group asked that its use be limited to coagulation of bean curd noting evidence was not 

available for its use in other food applications. Another interest group raised concerns about the 

environmental and human health concerns of mining and noted a toxicological review completed by the 

National Toxicology Program in 20061

. This review noted: “None of the long-term studies can be 

considered adequate tests of chronic toxicity or carcinogenicity by modern standards.” Furthermore it 

focused more on exposure from the 2001 World Trade Center attacks, and the limited information from 

mine workers was from a 1976 study that was available during the original TAP. While the handling 

subcommittee finds enough information at the current time to renew calcium sulfate, future NOSB’s 

should consider if a new Technical Review would be useful to review current data on alternative 

manufacturing methods, any new data available on environmental or human health concerns, and/or 

whether an annotation should be recommended. 

This material satisfies the OFPA Evaluation criteria and the Handling Subcommittee supports the 

relisting of calcium sulfate. 

1 https://ntp.niehs.nih.gov/ntp/htdocs/chem_background/pubnomsupport/gypsum1_508.pdf

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Motion to Remove 

The Subcommittee proposes removal of calcium sulfate-mined, from the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable:

none

Vote in Subcommittee

Motion by: Tom Chapman

Seconded by: Ashley Swaffar 

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

Carrageenan

Reference: §205.605(a)

Technical Report: 1995 TAP, 2011 TR; 2016 Limited Scope TR

Petition(s): NA

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987 –misspelled as 

‘carageenan’); Sunset renewal notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

Use: 

Carrageenan (CAS # 9000-07-1) is a generic term referring to a family of linear polysaccharides (i.e., 

complex carbohydrate chains) that are extracted from species of red seaweeds (Class Rhodophyceae). It 

is an FDA-approved direct food additive with an average molecular weight of 200-800 kDa, and may be 

referred to as “undegraded” or “native” carrageenan in the literature. The actual molecular weight of 

food-grade carrageenan represents a spectrum of molecular weights that are naturally present in live 

seaweed.

Carrageenan can function as a bulking agent, carrier, emulsifier, gelling agent, glazing agent, humectant, 

stabilizer, or thickener. It can promote gel formation and thicken, stabilize and improve palatability and 

appearance of foods. It is typically used at a rate ranging from 0.03% to 0.75%, and its most common 

uses are in dairy products, non-dairy "milk" analogs, meats, and drink mixes. It has been used in food 

processing for centuries.

Manufacture

During the 2012 sunset review concerns were raised about whether the manufacturing process to 

create carrageenan from seaweed might turn it into a synthetic material by the NOSB definition. 

Concerns were also raised about the environmental consequences of growing and harvesting these red 

seaweeds. As far as classification, the NOSB is still waiting for final guidance on the Classification of 

Materials and will not re-visit this issue until the guidance is final. A comprehensive technical report on 

issues related to seaweed harvesting is in development, but the results were not available in time for 

this review.

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Effect on Human Health

During the 2012 sunset review, public comment indicated considerable controversy surrounding this 

ingredient, both among the scientific community and the public. The scientific community disagreed 

over the research methodology used in studies and meta reviews that were not always consistent with 

how carrageenan behaves when ingested in food. Several public interest organizations supported one 

scientific group's approach over the others because of concerns that carrageenan caused inflammation 

or worse. The NOSB could not thoroughly investigate these issues within the very short period of time 

between the sunset announcement and the vote to renew. The members of the 2012 Handling 

Subcommittee did promise the public to do a more thorough analysis at the time of the next sunset 

review. Therefore, the Handling Subcommittee commissioned a limited scope technical report (see 

2016 limited scope TR, linked above) to supplement the one that was done in 2011. This report focused 

on the effects of the substance on human health: Evaluation question #10. The Subcommittee posed 

very specific questions about the research methodology regarding the molecular weights of 

carrageenan, the relative value of in vivo vs. in vitro studies, and the newest studies since the last TR 

was done in 2011.

The TR came back with the following statement, "Definitive conclusions regarding the varying degrees of 

human susceptibility to inflammation effects of carrageenan cannot be made from the available 

literature." (lines 173 - 174). And this, " However, since different animal species, different animals within 

the same species, and different human intestinal cell lines have produced different experimental results, 

it is reasonable to expect that humans may also experience varying degrees of sensitivity to carrageenan 

in the diet." (lines 177 - 180). 

It is also worth noting that in the time since the last review, the Joint FAO/WHO Expert Committee on 

Food Additives (JECFA) re-evaluated carrageenan for use in infant formula and changed their opinion on 

restricting its use to have an unrestricted status. (See TR for citation).

In the first posting the Handling Subcommittee made the following statement: "We are troubled that 

the research showing inflammation and glucose intolerance is all from one research team and has not 

been replicated". Public comment from the first posting reached almost 1000 pages, much of it with 

scientific debate and opinion about whose research to believe and whose to discard.

We have examined most of the references that were provided as citations regarding the replication 

issue and found that the claims of replication could not be substantiated. There were studies that had 

not been conducted yet2, studies by the same authors as the ones who showed inflammation3, studies 

using carrageenan as an agent to test other chemicals (but not the carrageenan itself)45

, and studies 

that were cited but without conclusions that supported the glucose intolerance issue.6

 Furthermore, 

one study claimed to support carrageenan extensively degrading into poligeenan in the digestive tract, 

2 "The clinical impact of carrageenan and diabetes, currently being studied in Germany" (University of Tuebingen, 

Dr. Robert Wagner and Dr. Norbert Stefan). https://clinicaltrials.gov/ct2/show/NCT02629705. 3 Bhattacharyya S, Feferman L, Unterman T, Tobacman JK. Exposure to common food additive carrageenan alone 

leads to fasting hyperglycemia and in combination with high fat diet exacerbates glucose intolerance and 

hyperlipidemia without effect on weight. J Diabetes Res. 2015;2015:513429. doi: 10.1155/2015/513429 

4 Jung TW, Lee S, Hong HC, et al. AMPK activator-mediated inhibition of endoplasmic reticulum stress ameliorates 

carrageenan-induced insulin resistance through the suppression of selenoprotein P in HepG2 hepatocytes. Mol Cell 

Endocrinol 2014;382:56-73. 5 Baek HS, Yoon JW. Direct involvement of macrophages in destruction of beta-cells leading to development of 

diabetes in virus-infected mice. Diabetes 1991;40(12):1586-97 6 Taché S, Peiffer G, Millet A-S, Corpet DE. Carrageenan gel and aberrant crypt foci in the colon of conventional and 

human flora-associated rats. Nutr Cancer 37:193–198 (2000). 

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but in fact did not show that result."7

The Subcommittee also looked at very recent work from the researchers who attempted to replicate 

these results.8 One of the key points made in the McKim article of 2016 was the challenge of using in 

vitro adverse effect data to predict risk for human disease. Among the conclusions presented: "The 

present work has shown that CGN does not cross intestinal epithelial cells, and is not cytotoxic to these 

cells. CGN did not increase cellular oxidative stress nor did CGN induce the expression of proinflammatory genes."

We understand why the TR came back with a somewhat nebulous statement about the research, 

because the experimental methods used in many experiments on both sides of the issue appear to be 

flawed. Without good research methodology and scientists who disagree over every conceivable point 

regarding carrageenan research, we can only agree that definitive conclusions cannot be made about 

the effects of carrageenan in the diet on human health.

The NOSB Handling Subcommittee is aware of research that came to our attention in the sunset review 

of other emulsifiers such as lecithin and guar gum which suggested that all of these ingredients may be 

contributing to metabolic syndrome, inflammatory bowel disease and obesity, simply by their impact on 

microbes in the gastrointestinal tract.9 This had been supported by previous research on Crohn's 

disease.10 While carrageenan has been more extensively studied than the other non-synthetic 

emulsifiers, there may be reason for concern that all emulsifiers can lead to inflammation and it is not a 

unique function of carrageenan.

Alternatives

The OFPA at 6518(m)(6) specifically directs that the NOSB “shall consider – the alternatives to using the 

substance in terms of practices or other available materials.” Therefore, in the first posting of 

carrageenan, for the April 2016 NOSB meeting, the NOSB requested specific information about use of 

carrageenan, alternatives and necessity for this material. 

Stakeholder responses indicated that carrageenan has been removed from many products over the last 

few years, and the products are either made without any replacement material, or with a different 

material. Stakeholder comments indicated that for the following products, for example, carrageenan 

was no longer necessary: whipping and heavy cream, chocolate milk, protein shakes, milk powders, 

yogurt, sour cream, cottage cheese, sugar free spreads, puddings, pie fillings, gummy bears, frozen soy 

desert, soy milk, processed meats, non-dairy beverages (nut and grain “milks”) and beer. 

We found that for some uses, particularly in dairy products and non-dairy milk-like beverages, there 

were suitable alternatives such as gellan gum, xanthan gum, and guar gum, although without 

carrageenan there is a tendency for sediments to collect at the bottom, and the beverage has to be 

shaken vigorously.

7 Pittman KA, Golberg L, Coulston F. Carrageenan: the effect of molecular weight and polymer type on its uptake, 

excretion and degradation in animals. Food Cosmet Toxicol 1976;14:85–93. 8 McKim J.M. et al. Food and Chemical Toxicology 96 (2016) 1 - 10 

9 Chassaing, B. et al. Dietary emulsifiers impact the mouse gut microbiota promoting colitis and metabolic syndrome. Nature 

519, 92–96 (March 2015) 10 Roberts, C. et al. Hypothesis: Increased consumption of emulsifiers as an explanation for the rising incidence of 

Crohn's disease Journal of Crohn's and Colitis, Volume 7, Issue 4, 1 May 2013, Pages 338–341

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There is some question as to whether there are alternatives to carrageenan in some infant formulas 

where it is needed to keep all the other synthetic nutrients in the liquid solution. However, we note that 

there is infant formula without carrageenan available in Europe.

For processed meat, such as sliced sandwich meats, commenters reported both success and lack of 

success in removing carrageenan. The shelf life of some of these meats is compromised without 

carrageenan since they don't hold together as well.

There are categories of organic products where no substitute has emerged. One key group is in 

vegetarian/vegan foods where gelatin is not acceptable because it is made from animals. These include 

gel capsules for vegetarian and vegan supplements.

Discussion

The Handling Subcommittee examined the issue of scientific bias, and found that there was no evidence 

to support the sweeping claims that all research in support of the safety of carageenan is funded by 

industry. All scientific papers are peer reviewed and there is no evidence that the reviewers are 

influenced by industry. We are unable to draw any conclusions from the bitter fight going on between 

scientists. 

During the first posting (April 2016) the Subcommittee posed a question regarding sensitivity to 

carrageenan, and whether or not that was enough reason to prohibit it in organic food. It appears that 

there are no epidemiological studies of populations regarding sensitivity but there are a number of 

anecdotal reports. Statements were made that the pathways of inflammation triggered by carrageenan 

were universal in all humans, but like the lack of replication, there was no evidence given in support of 

this statement. 

The NOSB has spent a considerable amount of time reviewing research and public comment on 

carrageenan since the 2012 sunset review of this material. We find that the body of scientific evidence 

does not support claims of widespread negative human health impacts from consumption of 

carrageenan in processed foods. We appreciate that there may be some individuals who have sensitivity 

to the material, but even that is not entirely clear from the body of scientific research. 

We recognize that consumer demand to remove carrageenan has already led to the removal of 

carrageenan from a number of categories of products and that other alternatives could be used to 

replace carrageenan in additional products. Subcommittee members think that there are alternatives to 

using carrageenan and recommend removing this material from the National List.

The Handling Subcommittee notes that any member of the public could petition for an annotation to 

limit the use to only those products for which there are no alternatives.

Motion to Remove 

The Subcommittee proposes removal of carrageenan from the National List based on the following 

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

6518(m)(6) - availability of alternatives. 

Vote in Subcommittee

Motion by: Zea Sonnabend

Seconded by: Ashley Swaffar

Yes: 5 No: 2 Abstain: 0 Absent: 1 Recuse: 0

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Glucono delta-lactone

Reference: §205.605(a) Glucono delta-lactone—production by the oxidation of D-glucose with bromine 

water is prohibited.

Technical Report: 2002 TAP; 2016 TR

Petition(s): 2002

Past NOSB Actions: 09/2002 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

Use: 

Glucono delta-lactone (GDL) is primarily used in the production of tofu, particularly in the production of 

silken tofu. In tofu production GDL serves as a coagulant. GDL can also be used as a curing agent, 

leavening agent, pH control agent and sequestrant. 

Manufacture: There are a variety of ways a GDL can be produced. The most common form has gluconic 

acid production is called the Blom process in which gluconic acid is produced by fermentation of glucose 

syrups by Aspergillus niger. Sodium hydroxide or calcium carbonate is added to this to produce 

gluconate salt. The gluconate salt is then isolated via evaporation, crystallization and then conversion to 

acid via ion-exchange. This process produces GDL via acid base reactions and fermentation (2016 

Technical Review pg. 10-11). Other processes to make GDL involve oxidation with bromine water 

(which is not allowed by the National List annotation) and oxidation with purified enzymes. 

International: 

GDL is not listed on the permitted substances lists of Canada, EU, Japan, Codex or IFOAM. 

Ancillary Substances: 

GDL is >99% pure and has no ancillary substances present. GDL is often sold in formulation with other 

additives specifically designed for the application – these substances should be reviewed separately as 

they are not ancillary substances. 

 

Discussion: 

The original petition and primary use of GDL is for the coagulation of tofu. Several coagulants for tofu 

exist including magnesium chloride, calcium chloride, calcium sulfate and magnesium sulfate. Acids 

such as citric or lactic acid can be used as well. Each of these substances produce a different type of 

tofu texture and flavor making distinctly different products. Calcium salts produce firmer tofu, sulfate 

salts produce soft tofu and GDL produces silken tofu. Citrus and Lactic acids produce acidified tofu 

where are often undesirable. Precise control of temperature and processing environments may allow 

different coagulants to produce different types of tofu. 

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The 2016 Technical Review examined human health and environmental impacts of GDL use and 

production but found low to no risk. The review did raise the question of classification, given the 

substance is produced via fermentation and acid-base reactions similar to that of citric acid (also listed 

on 205.605(a) nonsynthetic. The technical review also raised concerns about the potential for GMO 

enzymes to be used in the production of GDL via the oxidation with enzymes production method (not 

the most common form of production). 

The Handling Subcommittee sought further information from the public. In particular, if GDL is being 

used in applications other than tofu production for organic processed foods. One comment was 

received stating its use was necessary for a dairy product and another noted its use in a cosmetic good. 

Further, the handling subcommittee asked if GDL was removed from the national list, are alternative 

tofu coagulants such as calcium and sulfate salt sufficient to produce all forms of tofu. In response 

companies commented that alternatives on the list result in distinctly different and more firm tofu and 

that GDL is critical to silken, jelly-like tofu. Several tofu manufacturers commented for in favor of 

retaining GDL. Lastly, it was asked, should GDL produced from enzymes be prohibited or further 

restricted due to concerns about GMOs. Interest groups expressed concern that enzymatic GDL could 

possibly be produced via GMO substrates or enzymes and recommended the listing be annotated if 

renewed at all. As annotation changes are not possible during sunset review, this would require 

separate action from the board. Another commenter questioned the necessity of GDL stating it could 

be produced via alternative means, however, no information was presented on the commercial viability 

of this approach. 

This material satisfies the OFPA Evaluation criteria and the Handling Subcommittee supports the 

relisting of Glucono delta-lactone. 

Motion to Remove: 

The Subcommittee proposes removal of glucono delta-lactone from the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: 

none

Motion by Tom Chapman

Seconded by Ashley Swaffer

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

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Tartaric acid

Reference: §205.605(a) Tartaric acid - made from grape wine.

Technical Report: 2011 TR

Petition(s): 2011 Petition to remove from 205.605(b) - made from malic acid

Past NOSB Actions: NOSB meeting review 11/1995; 11/2005 recommendation; 12/2011 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

Uses: 

Tartaric acid is a natural organic acid that is in many plants especially grapes, bananas, and tamarinds. 

Tartaric acid can be used to create several different salts, including tartar emetic (antimony potassium 

tartrate), cream of tartar (potassium hydrogen tartrate), and Rochelle salt (potassium sodium tartrate). 

The primary uses of tartaric acid are associated with its salts. 

Tartaric acid and its salts have a very wide variety of uses. These include use as an acidulant, pH control 

agent, preservative, emulsifier, chelating agent, flavor enhancer and modifier, stabilizer, anti-caking 

agent, and firming agent. It has been used in the preparation of baked goods and confectionaries, dairy 

products, edible oils and fats, tinned fruits and vegetables, seafood products, meat and poultry 

products, juice beverages and soft drinks, sugar preserves, chewing gum, cocoa powder, and alcoholic 

drinks.

Tartaric acid and its immediate byproducts are particularly useful in baking. Due to its acidic properties, 

tartaric acid is used in baking powder in combination with baking soda (sodium bicarbonate). When 

tartaric acid reacts with sodium bicarbonate, carbon dioxide gas is produced, causing various baking 

products to ‘rise’ without the use of active yeast cultures. This action alters the texture of many foods. 

Tartaric acid and its salts are used in pancake, cookie, and cake mixes because of these properties. 

Cream of tartar is used to make cake frosting and candies 

International: 

The use of tartaric acid (C4H6O6; INS 334) is permitted for organic processing by the Canadian General 

Standards Board as a non-organic ingredients classified as a food additive in beverages. Use of the 

synthetic form is allowed only if the nonsynthetic form of tartaric acid is not commercially available. 

Tartaric acid derived from nonsynthetic sources is also permitted for use as a processing aid in 

beverages (the Canadian General Standards Board, 2011).

The European Economic Community (EEC) permits the use of tartaric acid as a food additive in organic

food if derived from a plant source, which is presumably grapes (EEC 889/2008, 2008). 

The CODEX Alimentarius Commission describe the functions of tartaric acid as an acidity regulator, 

adjuvant, anticaking agent, antioxidant, bulking agent, emulsifier, flour treatment agent, humectant, 

preservative, raising agent, sequestrant, and stabilizer. Tartaric acid from a plant source (i.e. 

nonsynthetic L(+) tartaric acid) is permitted for use as a food additive in organic food production 

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(although exclusions of the GFSA still apply). Tartaric acid is listed as an acceptable acidity regulator in 

the Codex General Standard for Food Additives (CODEX STAN 192-1995; CODEX Alimentarius 

Commission, 2011).

Discussion: 

The Handling Subcommittee, in its initial request for public comment, asked for comments regarding the 

use of tartaric acid and its essentiality in organic processing. 

During the Spring 2016 meeting the NOSB received several comments in support of the relisting of 

tartaric acid. Those comments included:

• “Tartaric Acid is used in our process to correct natural acid deficiencies in grape juice/wine and 

to reduce the pH of grape juice/wine where ameliorating material is used in the production of 

grape wine. The removal of Tartaric Acid from the National List will have a direct impact on our 

quality of wine. To my knowledge there has been no organic replacement or any other material 

that has the same effect or provides the same quality as the material in question.” 

• “Every wine we make has tartaric acid in it. It is used as a preservative and stabilizes the wine 

color by lowering the pH of wine. If we weren’t able to lower the pH we would have to use a 

higher amount of sulfur dioxide as a preservative that would exceed the 100 ppm total amount. 

It is also used as a stylistic tool to enhance the flavor and mouthfeel of the wine. We would 

discontinue our organic wines if we lost tartaric acid.” 

• “We should investigate whether tartaric acid from organic grape wine is available or would be 

available if we didn’t have this listing.”

• “Tartaric acid is the single most important input allowed in organic winemaking that helps 

counteract California's warm climate that causes low pH in grapes. It is therefore vital in 

producing quality wine made from organic grapes. Nearly all wines produced need some acid 

adjustment because very rarely do grapes ripen to the proper acid level to make wine. They 

therefore require pH and acidity correction to ensure proper fermentation and aging. Our 

almost 50 years of winemaking have demonstrated to us that some acid correction is almost 

always necessary, and tartaric acid is the most effective product available to make this 

adjustment. Tartaric Acid is a very important part of the organic winemaking process and we 

strongly support its continued use.” 

• “Tartaric acid is used in sour candies to enhance fruit flavors and sour intensity. Alternatives are 

less stable to warm temperature environments.” 

• “Tartaric acid is an absolute necessity for winemaking in California and for most warm weather 

winemaking regions. As grapes come in we replace some of the lost acidity with tartaric acid. 

Without it the wine would become susceptible to spoilage organisms and lack in flavor.”

Tartaric acid satisfies the OFPA evaluation criteria and the Handling Subcommittee supports its relisting. 

Motion to Remove 

The Subcommittee proposes removal of tartaric acid - made from grape wine, from the National List 

based on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if 

applicable: None

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Vote in Subcommittee

Motion by: Ashley Swaffar

Seconded by: Zea Sonnabend

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

Cellulose

Reference: §205.605(b) Cellulose - for use in regenerative casings, as an anti-caking agent (non-chlorine 

bleached) and filtering aid.

Technical Report: 2001 TAP; 2016 TR

Petition(s): 2001

Past NOSB Actions: 10/2001 meeting minutes and vote; 11/2007 recommendation; 05/2012 

recommendation

Recent Regulatory Background: National List amended 11/03/2003 (68 FR 62215); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review: 

Cellulose (CAS # 9004-34-6 alpha cellulose) is available in several different forms, each with varying 

functional qualities used for multiple purposes in organic handling. There are two specific forms of 

cellulose currently permitted for use in organic processing and handling: amorphous powdered cellulose 

and inedible cellulose casing. Uses in organic handling include: as a processing aid for filtration of juices; 

as an anti-caking agent ingredient for use in shredded cheese; and as a processing aid in the form of 

peelable/non-edible hot dog and sausage casings. Some of these uses in organic handling have been 

around since even before the creation of OFPA, with cellulose being allowed by certifiers in organic 

cheeses since 1994 and for use in organic meat products since 1999.

 

Cellulose in its natural form is the main structural component of higher plant cell walls and one of the 

most abundant organic substances on earth (EMBL, 2015)(TR 2-11-2016). Most commercially available 

cellulose (powdered) is produced from wood pulp or other plant sources (such as: corn cobs, soybean 

hulls, oat hulls, rice hulls, sugar beet pulp, etc.) through a delignification process that results in a 

chemically changed synthetic end product. The original process for making regenerated cellulose casing 

is called the viscose method. It converts cellulose fibers into regenerated fibers and films and with some 

minor changes is still in use today (this process was invented in the 1890’s). Cellulose is considered 

GRAS under CFR 121.101 (LSRO 1973).

The current Sunset review of cellulose by the Handling Subcommittee and ultimately the full NOSB 

included: a review of historic information, information provided during public comment period (oral 

and written) for the Spring and Fall 2016 NOSB meetings, a new Technical Evaluation Report (Feb.11, 

2016), and further research of available information that was conducted. This review also included a 

look at what possible ancillary substances might be used along with cellulose in its production for 

specific uses. 

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Internationally, cellulose is permitted under most organic standards outside of the U.S. for at least some 

uses and applications in organic processing or handling. Some examples of those allowed uses are:

• Canada - Allowed as a filtering aid (non-chlorine bleached) and for use in inedible regenerative 

 sausage casings (CAN/CGSB 2015).

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

 is authorized for use in the wine sector only for use as an inert filtering aid (EU Commission 2008).

• IFOAM - in Appendix 4, Table 1 “List of approved additives and processing/post-harvest handling aids” 

 as a processing and post-harvest handling aid with no annotation (IFOAM 2014). 

• Codex and Japan - No uses identified.

Discussion: 

During the 1st posting of cellulose the Handling Subcommittee asked 5 specific questions to aid in its 

review: 

• The NOP is still working on the 2012 NOSB recommendation to add the word “powdered” to part 

of the annotation. Thus, no NOSB action on this issue is required at this time. Numerous comments 

on this discussion point gave a mixed reaction as to what impact the addition of the more 

restrictive wording to the annotation might have on organic handling. It was inconclusive.

• Organic handlers and some certifiers acknowledged that cellulose is still very much in use in 

organic handling and/or processing, and that for these specific uses there still does not seem to be 

a suitable alternative at this time. Thus, organic stakeholders that use this material via one of the 

three currently allowed uses, have provided information on how necessary cellulose is to their 

handling process. 

• The TR states that: Although it is theoretically possible to use cotton and other natural fibers as 

sources of cellulose for filtering, making food-grade cellulose in a functional form requires 

synthetic processes. Alternative plant sources are also limited by technical considerations and 

production capacity.

• During public comment and also mentioned in the TR were concerns (also stated during previous 

sunset reviews) regarding the use of wood pulp as a source for cellulose and the environmental 

impact that this could possibly have. Also, concerns were raised about environmental problems 

caused by waste cellulose generated from food processing. The new TR states that conversion of 

cellulosic food wastes into useful products is the subject of research, as well as that involving 

additional cellulose waste from filtration aids and/or spent casings. The research is based more on 

seeking to add value, but is also driven by environmental concerns, rising disposal costs, and 

governmental regulations. Thus, research is underway looking at the best use of the waste 

products and/or spent materials, which should help to ease those concerns in due time.

Ancillary substances are intentionally added to a formulated generic handling substance on the National 

List. These substances do not have a technical or functional effect in the finished product, and are not 

considered part of the manufacturing process that has already been reviewed by the NOSB. While some 

of these substances are removed or consumed in processing, many may remain in the final product in 

tiny amounts.

Information provided in the latest Technical Evaluation Report (TR) (Feb. 11, 2016) and also during 

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public testimony (written and oral) provided the Subcommittee the following list of ancillary substances 

that are sometimes used in the production of cellulose for use in organic handling and processing. The 

TR was very clear that there are well defined sources of commercially available cellulose that do not 

include any ancillary substance, as well as those that might use ancillaries listed in the chart below:

Functional Class Ancillary Substance Name

Carriers and fillers, agricultural or nonsynthetic

Potato starch, dextrose

Carriers and fillers, synthetic Propylene glycol

Preservatives Polysorbate 80, enzymes

Binder/Plasticizer Lecithin, propylene glycol, mineral oil

Anti-caking & anti-stick agents Mineral oil, animal oil, vegetable oil, resin

Releasing agents Mineral oil

Subcommittee discussion points and request for additional input:

• “Mineral oils, untreated or mildly treated” are on the combined IARC/NTP list. The latest 

Technical Evaluation Report (March 12, 2015) for mineral oil that was done for the Livestock 

Subcommittee states that for refined mineral oil, the refining process removes the materials 

that pose the carcinogen concerns. It also mentions that according to the FDA database for 

“Everything Added to Food in the United States” (EAFUS), mineral oils are approved for use as 

direct, secondary direct, and indirect food additives for human and animal feed (FDA, 2014). 

FDA permits the direct addition of mineral oil to food for consumption under 21 CFR 172.842 

and 172.878. Please provide the Subcommittee with any information as to whether or not 

mineral oil is needed/or used as an ancillary for cellulose? Also, please provide us with any 

information as to the type of mineral oil currently being used? For example: refined, mildly 

treated, or untreated mineral oil. 

• The TR mentions releasing agents that are used for peeling, retaining moisture, or that help to 

add smoke in sausage making, but no specific ones were mentioned (we were able to identify 

one: mineral oils). The Handling Subcommittee requests from handlers who are using releasing 

agents a list of any releasing agents that you are aware of, so that we could amend our list of 

allowed ancillaries for use in cellulose formulations. Also, please provide us with any other 

ancillary substances that are currently in use that we have not listed.

• It appears that processed cheese can be made with/or without cellulose. Thus, it brings into 

question whether or not cellulose is necessary or essential in organic shredded cheese 

production (it appears manufacturers are making it both ways). Could you provide the NOSB 

with information as to why some shredded cheeses are made with cellulose, while others are 

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not? What makes the use of cellulose necessary in your process?

Motion to Remove 

The Subcommittee proposes removal of cellulose from the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: None.

Vote in Subcommittee

Motion by: Harold V. Austin IV

Seconded by: Lisa De Lima

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

Potassium hydroxide

Reference: §205.605(b) Potassium hydroxide - prohibited for use in lye peeling of fruits and vegetables 

except when used for peeling peaches.

Technical Report: 2001 TAP; 2016 TR

Petition(s): 2001 petition, 2011 petition to amend annotation

Past NOSB Actions: 10/1995 meeting minutes and vote; 11/2005 recommendation; 12/2011 

recommendation

Recent Regulatory Background: Added to the National list 12/21/2000 (65 FR 80548); National List 

amended 11/03/2003 (68 FR 62215); National List amended 05/28/2013 (78 FR 31815) 

Sunset Date: 5/29/2018

Subcommittee Review

Potassium hydroxide is a synthetic, inorganic compound produced by the electrolysis of potassium 

chloride. Also known as potash, it is a strong base and alkaline in solution. Much of its utility in food 

processing is based on its function as a caustic strong base. Potassium hydroxide is widely used in food 

processing as a pH adjuster, cleaning agent, stabilizer, thickener and poultry scald agent. It is also used 

in the lye peeling of fruits and vegetables. The FDA lists potassium hydroxide as GRAS for humans (21 

CFR 184.1631), which are allowed under 21CFR 173.315(a)(1) - Chemicals used in washing or to assist in 

the peeling of fruits and vegetables. In fruit and vegetable peeling, potassium hydroxide serves to 

weaken the glycolytic bonds of pectin, which is responsible for skin adhesion. Weakening these bonds 

allows the peeling of fruit and vegetable skins by water spray or other mechanical methods. 

According to the TR, peaches peeled for canning or pickling use a 1.5% solution of lye at a temperature 

slightly below 145°F (<62°C) for about 60 seconds, followed by a wash and dip into a solution of 0.5-

3.0% citric acid. Because hot water cannot be used for freezing peaches, they require a higher solution - 

about 10% - and a treatment time of about 4 minutes to be peeled. Lye is removed by thorough 

washing, and again citric acid is used to neutralize the pH of the fruit.

International: 

• Canada - Canadian General Standards Board Permitted Substances List - Allowed for pH 

adjustment only. Prohibited for use in lye peeling of fruits and vegetables (CAN/CGSB 2011 

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Table 6.6).

• CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and 

Marketing of Organically Produced Foods (GL 32-1999) – Allowed for pH adjustment for sugar 

processing (FAO/WHO Joint Standards Programme 1999, Table 4). 

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

Caustic potash is on Annex VII, “Products for cleaning and disinfection” (EU Commission 2008). 

However, it does not appear in Annex VIII, “Certain products and substances for use in 

production of processed organic food, yeast and yeast products.”

• Japan Agricultural Standard (JAS) for Organic Production—“Limited to be used for processing 

sugar as pH adjustment agent” (Japan MAFF 2000). 

• IFOAM – Organics International (IFOAM) – Not found.

History: 

In 1995, the NOSB approved the addition of potassium hydroxide to 205.605(b), with an annotation 

prohibiting its use in the lye peeling of fruits and vegetables. This restriction was based on concerns 

about the environmental effects of the waste products of the lye peeling process, and the fact that 

mechanical and non-chemical alternatives were available for most fruits and vegetables. 

In 2001, a petitioner sought to expand the use of potassium hydroxide by amending the annotation to 

read ―prohibited for use in lye peeling of fruits and vegetables except when used for peeling peaches 

during the Individually Quick Frozen (IQF) production process. The 2001 TAP review for that expansion 

noted that ―The stone fruit (peaches, nectarines, and apricots) do not appear to currently have 

alternative methods available on a commercial scale to achieve peeling without the use of caustic 

substances. The 2001 TAP review also noted that the environmental effects that had originally resulted 

in the restrictive annotation could be mitigated with the use of good wastewater management 

practices. Peach processing plants are generally restricted by state and local wastewater treatment 

requirements, and the natural acidity of the fruit and additional pH adjustments buffer the alkalinity of 

the wastewater. Because no commercially viable alternatives are available, and processing practice 

mitigates the potential environmental effects, the NOSB approved the expanded annotation. 

A new petition from the same petitioner was filed in 2011, seeking to expand the annotation again to 

allow the use of potassium hydroxide for the peeling of fresh peaches to be canned. The petition 

confirms the lack of commercially viable alternatives for this use, and the mitigation of potential 

environmental impact. The processing of peaches for canning and freezing is identical up until the 

freezing or canning step. Based on the petition, the 2001 TAP review, and the rationale of the 2001 

NOSB, the Handling Committee supported the expansion of this annotation to allow potassium 

hydroxide to be used in the peeling of both IQF and canned peaches. Accordingly, since canning and 

freezing are the primary commercially processing methods used for peaches, the NOSB full board 

favored removing the language regarding IQF methods so that the exception to the prohibition on lye 

peeling applies to all peach peeling.

Discussion: 

The Handling Subcommittee in its initial request for public comment asked: 

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1. For what purposes is potassium hydroxide used in organic processing?

2. Are there alternatives for those uses?

Public comments:

During the Spring 2016 meeting the NOSB received several comments regarding potassium hydroxide. 

Those comments included:

• Potassium hydroxide is used as a cleaning agent and is not used in our organic product as it is 

also prohibited by TTB to be added to wine but is approved as a cleaning agent. The removal of 

Potassium hydroxide from the National will have a huge impact for us; there is nothing at the 

moment that can be used as a replacement to effectively clean as well as potassium hydroxide. 

To my knowledge there has been no organic replacement or any other material that has the 

same effect or provides the same quality as the material in question.

• It is a better fit as a processing aid that is much gentler to the proteins in buttermilk

• Potassium hydroxide is a hazardous material, possibly one of the most hazardous and toxic on 

the National List. 

• Of the certifiers that wrote in stated approximately 74 of their clients use this product.

While there is concern about the toxicity and hazards of this material the Subcommittee would like 

to see public comments address the questions put forth in this document. 

This material satisfies the OFPA evaluation criteria and the Handling Subcommittee supports the 

relisting of potassium hydroxide.

Motion to Remove 

The Subcommittee proposes removal of potassium hydroxide from the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable:

None

Vote in Subcommittee

Motion by: Ashley Swaffar

Seconded by: Scott Rice

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

Silicon dioxide

Reference: §205.605(a) Silicon dioxide - Permitted as a defoamer. Allowed for other uses when organic 

rice hulls are not commercially available.

Technical Report: 1996 TAP, 2010 TR

Petition(s): 2010 petition to remove

Past NOSB Actions: 09/1996 minutes and vote; 11/2005 recommendation; 12/2011 recommendation

Recent Regulatory Background: Added to NL 12/21/2000 (65 FR 80548); National list amended 

05/28/2013 (effective 11/03/2013) (78 FR 31815) 

Sunset Date: 11/03/2018

Subcommittee Review

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Use: 

Synthetic amorphous silicon dioxide is used as a food additive for various functions including:

• An anticaking agent in foods

• A stabilizer in beer production, and filtrated out of the beer prior to final processing

• An adsorbent in tableted foods 

• A carrier 

• A defoaming agent 

• Used in organic seed pellets 

Manufacture:

Silicon dioxide can be manufactured by three methods: a vapor-phase hydrolysis process, a wet process, 

or a surface-modified treatment. According to FDA regulations, silicon dioxide (as a food additive) 

should be manufactured by vapor phase hydrolysis or by other means whereby the particle size is such 

as to accomplish the intended effect. Silicon Dioxide can be produced as a nanomaterial, but for use in 

organics the material would have to be petitioned to be placed on the National List. As stated in NOP 

Policy Memorandum from March 2015: As with other substances, no engineered nanomaterial will be 

allowed for use in organic production and handling unless the substance has been: 1) petitioned for use; 

2) reviewed and recommended by the NOSB; and 3) added to the National List through notice and

comment rulemaking. Currently there is no silicon dioxide produced with nanotechnology on the 

National List. 

International: 

Silicon Dioxide is permitted in organic handling by Canada, CODEX, European Union, IFOAM, and Japan. 

In the EU its use is restricted to an anticaking agent for herbs & spices, of plant origin. In Japan its use is 

limited to processed foods of plant origin as gel or colloidal solution.

Ancillary substances: None reported in 2010 TR

 

History:

In 2010 a petition to remove silicon dioxide was put forward by RIBUS, the manufacturer of 

commercially produced rice based certified organic alternative to silicon dioxide. In 2011, the NOSB did 

not pass the petition. New data was presented in the petition claiming that a reformulation of the rice 

based alternative could now be substituted for silicon dioxide at nearly 1:1 rations, but the Handling 

Committee felt the data was limited, not published from a third party source, and did not conclusively 

demonstrate its applicability in all products and processes. 

The Subcommittee did however wish to acknowledge the availability of a natural alternative and even 

though they did not vote to remove silicon dioxide in its entirety they did pass (Yes: 11, No: 3) a 

recommendation to amend the annotation of silicon dioxide 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 group(s)).” (b) Synthetics 

allowed—Silicon dioxide—providing sufficient evidence showing non-synthetic alternatives are not 

commercially available for a specific product/process is presented. 

Resulting in its current listing as: Silicon dioxide—Permitted as a defoamer. Allowed for other uses 

when organic rice hulls are not commercially available

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The Subcommittee, in its 2010 recommendation, also publically noted that additional information and 

clarification of processors’ needs regarding silicon dioxide would be needed for future deliberations by 

the NOSB. 

Discussion: 

The 2010 TR did not find the manufacture or use of silicon dioxide to be harmful to people or the 

environment. The Subcommittee asks if silicone dioxide should remain on the list based on §205.600(b) 

- In addition to the criteria set forth in the Act, any synthetic substance used as a processing aid or 

 adjuvant will be evaluated against the following criteria: 

(1) The substance cannot be produced from a natural source and there are no organic substitutes

 

During the first posting, the Handling Subcommittee asked the public for the following information:

1. Are there instances where due to lack of availability of organic alternatives, you must use silicon 

 dioxide? 

2. Are there instances where the organic alternative does not perform the needed function and 

 therefore you must use silicon dioxide? If so, what are those functions? And what was the 

 undesired result that lead to the need to use silicon dioxide? 

Public comment in response to the above questions included: 

Silicon dioxide is essential for certified organic seed pellets; for anticaking agent in organic powders, 

including organic cheese powders; rice hulls aren’t able to meet the various applications where silicon 

dioxide is used; in organic dry flavors rice hulls have not performed as needed to disburse flavor actives 

evenly, and take up moisture; the rice hull application as a substitution for silicon dioxide as an anticaking agent has not worked at the 2% application, instead the rice hull rate has been 15-50%; rice hulls 

do not function like silicon dioxide when used as a flow agent for rice syrup solids; used in beer 

clarification. 

Comment from multiple organizations asked that the NOSB revisit the original annotation put forth by 

the Board in 2011, in order to encourage the development and commercialization of alternative organic 

silica products. No new information was brought forth to indicate that the manufacture or use of silicon 

dioxide is harmful to people or the environment. Public comment by producers indicated that organic 

rice hulls are not a viable alternative for all current uses. The Subcommittee recommends that silicon 

dioxide remain on the National List. 

Additional Information Requested: 

Based on information reviewed, the Subcommittee is not aware of any ancillary substances used in 

silicon dioxide. If the public is aware of any ancillaries please provide information via public comment. 

Motion to Remove 

The Subcommittee proposes removal of silicon dioxide from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Vote in Subcommittee

Motion by: Lisa de Lima

Seconded by: Tom Chapman

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

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Colors: Beta-carotene extract

Reference: §205.606(d) Colors derived from agricultural products - Must not be produced using 

synthetic solvents and carrier systems or any artificial preservative 

(2) Beta-carotene extract color - derived from carrots or algae (pigment CAS# 7235-40-7).

Technical Report: 2011 TR

Petition(s): 2007, 2009

Past NOSB Actions: 04/2007 recommendation, 12/2011 recommendation

Recent Regulatory Background: National List amended 06/27/2007 (72 FR 35137); National List 

amended 05/28/2013 (78 FR 31815) 

Sunset Date: 5/29/2018

Subcommittee Review

Discussion: 

Beta-carotene was petitioned by color manufacturers in 2007. No TAP was requested. The NOSB 

Handling Subcommittee rejected the petition to add this material to 205.606 stating: “the petitioner did 

not provide credible information regarding the lack of supply of organic raw material, and the ability to 

process them as organic”. (Vote: 4:1) However, at the March 2007 NOSB meeting the material was 

approved.

The Interim Final Rule (FR 35141) includes the following: “Though a significant number of comments 

were received, very few comments submitted were from processors or handlers. Comments from this 

segment of the industry would be helpful in developing a final rule. A number of comments expressed 

concern regarding the information and criteria used for determining the fragility of the organic 

ingredient supply or organic availability of the proposed 38 nonorganic agricultural ingredients.“

The Interim Final Rule also includes the following: “As a result of the district court's final order and 

judgment in Harvey v. Johanns and requests for an extension of the public comment period on AMS-TM07-0062, AMS is issuing this interim final rule to: (1) Permit the use of the 38 ingredients during the 

extended comment and final rulemaking periods to minimize the impact to the organic industry; and (2) 

extend the comment period (60 days) to receive additional comments regarding the addition of the 38 

non-organic agricultural ingredients to § 205.606. Effective Date Effective June 9, 2007, these 38 

substances were prohibited for use in processed products labeled as ‘organic.’ Continued loss of the use 

of these products would disrupt the trade of food products currently being labeled as ‘organic’. 

Therefore, the continued use of these products as ingredients in foods labeled as ‘organic’ is necessary 

to prevent possible significant business disruption for organic producers and handlers. Accordingly, 

pursuant to 5 U.S.C. 553, it is found, and determined, upon good cause, that it is impracticable, 

unnecessary, and contrary to the public interest to give further notice prior to putting this rule into 

effect, and that good cause exists for not postponing the effective date of this interim final rule until 30 

days after publication in the Federal Register.” 

In 2009, another manufacturer petitioned to add an amendment to the listing: “....Derived from carrots 

or algae”. The petitioner stated: “Our research over the past few years shows that at this time the only 

source of beta-carotene that can be extracted using NOP compliant nonsynthetic methods is algae. The 

algae derived beta-carotene uses extraction methods of CO2, ethanol or vegetable oil.” 

A Technical Report was requested and received in July 2011. 

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The TR indicated that a common source of beta carotene color was derived from the micro-algae 

Dunaliella salina and Dunaliella bardawil. These species are cultivated in Australia, for example. The TR, 

lines 327-350, describes the intensive culture system of production in a high salt, nitrate rich medium. 

The TR further states: “Dunaliella species are commonly observed in salt lakes in all parts of the world 

from tropical to temperate to polar regions where they often impart an orange-red color to the water. 

As in commercial cultivation of the production, β-carotene is accumulated as droplets in the algal 

chloroplast stroma, especially under the environmental conditions in high temperature, high salinity, 

high irradiance, and nutrient limitation (low nitrogen). Then, β-carotene may be obtained from algal 

biomass or dried powder by using hot edible oil extraction and supercritical carbon dioxide, see EQ #2. 

In addition, it is desirable to re-utilize the culture medium remains after harvesting (biomass removal). 

Dunaliella growth medium could be recycled biologically by treating the medium with bacteria that are 

naturally present in medium because of the high concentration of glycerol, amino acids, and other 

organic compounds (Ben-Amotz, 1995). In a review article conducted by Dufosse et al. (2005), they 

concluded that algal forms are the richest source of pigments and can be produced in a renewable 

manner, since they produce some unique pigments sustainably. The report also stated that the 

production of β-carotene from Dunaliella will surpass synthetic as well as other natural sources due to 

microalgae sustainability of production and their renewable nature. (TR 530-545).

The TR supported the petitioner’s research findings. Therefore the Handling Subcommittee voted 4: 0 

with 3 absences to approve this amendment, and the NOSB in December 2011 voted 14: 0 to approve 

the amendment. 

The NOSB in 2011 found that the material met all the OFPA Criteria, and in 2013 the Final Rule was 

published (78 FR 31815).

The NOSB is in the process of reviewing use of all marine plants which are presently on the National List, 

and will be requesting a limited Technical Report. The marine plants topic will be reported on as a 

separate item at the Fall 2016 meeting.

Additional information requested by NOSB 

1. Has there been any change in the ability of manufacturers to produce beta-carotene color from 

 carrots using NOP compliant extraction methods?

2. Is this color necessary for organic processors?

3. Which species of algae are used and from where are they harvested?

4. If the typical species used are from the genus Dunaliella (as cited in the TR) is harvesting of these 

 species of micro algae from the wild, certified wild-crafted, or cultivated? 

5. When used as a color, is this material also a source of Vitamin A?

Public comment on continued listing of this material indicates support from producers of the colors and 

support from those producers who use the color. Some certifiers indicate that the material is not widely 

used. Consumer groups consider this color is not essential (205.600(b) (6) ), and if made from carrots, 

that organic carrots are available (205.600(b) (1) ) and thus this material is not compatible with 

sustainable agriculture (OFPA 6518(m) (7) ), and that the substance’s primary use is a color (205.600 (b) 

(4)).

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Motion to Remove 

The Subcommittee proposes removal of beta-carotene extract color - derived from carrots or algae 

(pigment CAS# 7235-40-7) from the National List based on the following criteria in the Organic Foods 

Production Act (OFPA) 6518 (m) (7) and 7 CFR 205.600(b) (1) and (4) and (7) .

Vote in Subcommittee

Motion by: Jean Richardson

Seconded by: Ashley Swaffar

Yes: 2 No: 5 Abstain: 0 Absent: 1 Recuse: 0

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National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Sodium chlorite, for the generation of chlorine dioxide gas

August 16, 2016

Summary of Petition (initial petition; petition addendum): 

On October 8, 2015, the NOP received a petition to add chlorine dioxide (ClO2) (CAS #10049-04-4) dry 

gas to §205.605 (b) of the National List, nonagricultural (nonorganic) synthetic substances allowed as 

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

ingredients or food group(s)).” The petition was revised November 30, 2015, revised again on December 

1, 2015 and forwarded to the Handling Subcommittee (HS) December 2, 2015.

This material is petitioned for use as an anti-microbial pesticide, sanitizer and/or disinfectant for fruits 

and vegetables. It is used for the direct treatment of fruits and vegetables during storage, transportation 

and food preparation applications with no requirement for post treatment rinse.

ClO2 gas is produced by impregnating zeolite with sodium chlorite and then activating the zeolite with a 

solid or liquid acid such as citric acid. An unspecified buffer is used. 

ClO2 gas is used in post-harvest handling as a disinfectant to kill microorganisms. It is used in the direct 

treatment of vegetables, fruits and nuts to reduce spoilage and pathogenic organisms. In these 

applications the mode of ClO2 is a killing agent of these pathogenic organisms.

It is applied as a dry pure gas in closed containment. Treatment is done over several hours until the 

substance is completely consumed. ClO2 is converted to a chloride ion on the food products. In 

processing facilities, use of this material is used as an oxidizer, cleaner, deodorizing agent. It is applied as 

a dry pure gas at the point of need. Application rates vary and will convert to chloride ion when reacting 

with a wide variety of organic matter.

Summary of Review:

The HS’s initial review of the petition determined a need for revision by the petitioner. The HS found the 

initial petition sought to list a process rather than a material. If reviewed as petitioned, the HS would 

have reviewed several materials: sodium chlorite, zeolite acting as a carrier which is impregnated with 

sodium chlorite, acidic chlorine dioxide activators and related buffers. When used together as directed, 

these materials produce ClO2 gas.

The HS returned the petition to the petitioner April 18, 2016, with a request to revise to “sodium 

chlorite, for the generation of chlorine dioxide gas.” The HS believes a petition considering sodium 

chlorite for the particular use of gas generation is more consistent with how other sodium chlorite 

materials have been reviewed. It is very similar to the acidified sodium chlorite that is already on the list 

at 205.605(b), however that substance was petitioned as a solution, whereas this one is used as a 

fumigant gas. 

Therefore, the HS asked that the petitioner revise the petition to “sodium chlorite, for generation of 

chlorine dioxide gas.” If listed, certifiers and/or material review organizations will review the sodium 

chlorite product and the attendant components noted above. In its revision request, the HS also asked 

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the petitioner if, as with use of other sodium chlorite materials, produce treated with ClO2 dry gas 

requires a potable water rinse sufficient that residual chlorine levels in the water shall not exceed the 

maximum residual disinfectant limit under the Safe Drinking Water Act.

The petitioner responded to the two HS requests above, resubmitting the petition as “sodium chlorite, 

for generation of chlorine dioxide gas.” In response to the question regarding need for a post-treatment 

potable water rinse, the petitioner noted that ClO2 gas rapidly reacts with produce surfaces and 

residues of concern, primarily ClO2 or chlorite ion, do not persist. Gas applications are different than 

water solution applications and precautionary potable rinses are not required1

. 

Because of this material’s intended use as killing agent for pathogenic organisms, the petitioner’s 

formulated product is EPA registered. While the petitioner notes the target use of ClO2 gas is for 

vegetables and fruit, the EPA label for the formulated product only allows for use on stored potatoes. It 

is likely the petitioner seeks EPA allowance for broader use on fruit and vegetables as evidenced by their 

formulated product name “FruitGard®.”

As noted, acidified sodium chlorite is already listed at 205.605(b) and at the April 2016 NOSB meeting, 

the Board voted unanimously to add hypochlorous acid to 205.605(b). Like acidified sodium chlorite and 

hypochlorous acid, ClO2 gas has the potential to offer handling operations a material that has strong 

antimicrobial properties and is compatible with the fundamental principles of organic production.

Category 1: Classification 

1. Substance is for: X Handling 

2. For HANDLING and LIVESTOCK use: 

a. Is the substance _____ Agricultural or X Non-Agricultural?

 Describe reasoning for this decision using NOP 5033-2 as a guide: 

 

The substance is a mineral.

b. If the substance is Non-agricultural, 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 substance is not manufactured, produced or extracted from a natural source.

3. For LIVESTOCK: 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? N/A

1 Smith, D.J. et al. Chloroxyanion residues in cantaloupe and tomatoes after chlorine dioxide gas sanitation. Journal of 

Agricultural and Food Chemistry, 2015, 63, 9640-9649.

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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)]

ClO2 gas is a known oxidizer. However, when used as prescribed in the petition, there are no 

known interactions with other substances used in organic production.

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)]

ClO2 gas is not persistent and not a known bio-accumulative substance. When used in the 

intended use in an enclosed environment and allowed to degrade to ClO2 or the chlorite ion, 

there is no toxicity.

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

Manufacturing sodium chlorite produces some byproducts, such as chlorine dioxide, which 

cannot be immediately released into the environment. This petition is for the use of sodium 

chlorite as chlorine dioxide gas. As noted above, if used as intended, the substance degrades to 

ClO2 or chlorite ions.

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]. 

As noted in the petition, the primary concern of exposure to the substance is acute toxicity 

related to inhalation where the substance is a known irritant to eyes and mucal membranes. 

Severe exposure (beyond amounts available by petitioned product) can result in chemically 

induced pneumonia and or death. However, if used as intended, the substance degrades to ClO2 

or chlorite ions.

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 used according to the petitioned use, applied at low levels and in secure conditions, the 

substance does not have adverse impacts in the agroecosystem.

6. Are there any adverse impacts on biodiversity? (§205.200) 

When used according to the petitioned use, applied at low levels and in secure conditions, the 

substance does not have adverse impacts on biodiversity.

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)]

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There are some fluid alternatives such as sodium hypochlorite or chlorine dioxide in liquid form, 

the latter of which is already listed on the National List. However, presently there are no antimicrobial pesticides, sanitizers or disinfectants in gas form on the National List.

2. For Livestock substances, and Nonsynthetic substances used in Handling: In balancing the 

responses to the criteria above, is the substance compatible with a system of sustainable 

agriculture? [§6518(m)(7)]

N/A

Category 4: Additional criteria for synthetic substances used in Handling (does not apply to 

nonsynthetic or agricultural substances used in organic handling): 

Describe how the petitioned substance meets or fails to meet each numbered criterion.

1. The substance cannot be produced from a natural source and there are no organic substitutes; 

(§205.600(b)(1)) 

The substance is a mineral not derived from a natural mined source.

2. The substance's manufacture, use, and disposal do not have adverse effects on the environment 

and are done in a manner compatible with organic handling; (§205.600(b)(2)) 

When used as intended, the substance degrades to ClO2 or chlorite ions that have no adverse 

effects on the environment.

3. The nutritional quality of the food is maintained when the substance is used, and the substance, 

itself, or its breakdown products do not have an adverse effect on human health as defined by 

applicable Federal regulations; (§205.600(b)(3)

Neither the nutritional quality of the food nor human health is impacted with use of ClO2 gas or 

its breakdown products of ClO2 or chlorite ions.

4. The substance's primary use is not as a preservative or to recreate or improve flavors, colors, 

textures, or nutritive value lost during processing, except where the replacement of nutrients is 

required by law; (§205.600(b)(4)) 

The petitioner describes the preservative qualities in the use of this substance. However, the 

preservative qualities are secondary to its primary action, which is a disinfectant used to kill 

microorganisms.

5. The substance is listed as generally recognized as safe (GRAS) by the Food and Drug 

Administration (FDA) when used in accordance with FDA's good manufacturing practices (GMP) 

and contains no residues of heavy metals or other contaminants in excess of tolerances set by 

FDA; (§205.600(b)(5)) 

Sodium chlorite, for the generation of ClO2 gas does not appear in the FDA GRAS inventory. 

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However, ClO2 generated using sodium chlorite in calcined or sulfated kaolin clay2

, and ClO2 

generated from particles composed of sodium polyphosphate, magnesium sulfate, sodium 

silicate and sodium chlorite that are incorporated into low density polyethylene (LDPE) foodpackaging films appear in the FDA GRAS inventory3

. 

6. The substance is essential for the handling of organically produced agricultural products. 

(§205.600(b)(6)) 

While other sanitizers and disinfectant substances appear on the National List, none are 

currently present in gas form. As a gas form, ClO2 reacts rapidly and completely thereby 

reducing or negating the need for de-chlorination of waste water streams. Liquid forms of ClO2 

mainly treat the rinse waters and are not as effective in treating microorganisms on produce. 

Dry gas applications appear to have greater effectiveness in penetrating coarse or porous 

produce. The use of ClO2 in gas form stands to reduce water usage.

7. In balancing the responses to the criteria in Categories 2, 3 and 4, is the substance compatible 

with a system of sustainable agriculture [§6518(m)(7)] and compatible with organic handling?

(see NOSB Recommendation, Compatibility with Organic Production and Handling, April 2004) 

Like acidified sodium chlorite and hypochlorous acid, ClO2 gas has the potential to offer 

handling operations a material that has strong antimicrobial properties and is compatible with 

the fundamental principles of organic production.

Category 5: Additional criteria for agricultural substances used in Handling (review of commercial 

unavailability of organic sources): 

1. Is the comparative description as to why the non-organic form of the material /substance is 

necessary for use in organic handling provided? 

N/A

2. Does the current and historical industry information, research, or evidence provided explain how 

or why the material /substance cannot be obtained organically in the appropriate form to fulfill an 

essential function in a system of organic handling?

N/A

3. Does the current and historical industry information, research, or evidence provided explain how 

or why the material /substance cannot be obtained organically in the appropriate quality to fulfill 

an essential function in a system of organic handling?

N/A

4. Does the current and historical industry information, research, or evidence provided explain how 

or why the material /substance cannot be obtained organically in the appropriate quantity to fulfill 

2 Tarantino, FDA Agency Response Letter GRAS Notice No. GRN 000161, 2005.

3 Rulis, FDA Agency Response Letter GRAS Notice No. GRN 000062, 2001.

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an essential function in a system of organic handling?

N/A

5. Does the industry information about unavailability include (but is not limited to) the following?:

Regions of production (including factors such as climate and number of regions);

a. Number of suppliers and amount produced;

N/A

b. Current and historical supplies related to weather events such as hurricanes, floods, and 

droughts that may temporarily halt production or destroy crops or supplies;

N/A

c. Trade-related issues such as evidence of hoarding, war, trade barriers, or civil unrest that 

may temporarily restrict supplies; or

N/A

d. Other issues which may present a challenge to a consistent supply?

N/A

6. In balancing the responses to the criteria in Categories 2, 3 and 5, is the substance compatible with 

a system of sustainable agriculture [§6518(m)(7)] and compatible with organic handling? (see 

NOSB Recommendation, Compatibility with Organic Production and Handling, April 2004) 

N/A

Classification Motion: 

Motion to classify sodium chlorite, for the generation of chlorine dioxide gas as nonagricultural,

synthetic. 

Motion by: Scott Rice

Seconded by: Jean Richardson

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

National List Motion: 

Motion to add sodium chlorite, for the generation of chlorine dioxide gas as petitioned at 

205.605(b) 

Motion by: Scott Rice

Seconded by: Ashley Swaffar

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

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National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Oat Protein Concentrate 

May 17, 2016

Summary of 

Petition https://www.ams.usda.gov/sites/default/files/media/Oat%20Protein%20Concentrate.pdf

Oat protein concentrate is being petitioned by manufacturer Tate & Lyle for addition to §205.606, as a 

natural component of oats, an agricultural commodity. According to the petition the substance is 

isolated from oat bran through a simple process of grinding, heating, and water extraction. No synthetic 

chemical additions or solvents are used in the manufacturing process (pH adjustment and/or solvent 

extraction) being petitioned. The only additives used in producing oat protein concentrate are water and 

enzymes. The alpha-amylase enzyme used is derived from a non-pathogenic, non-GE/GM 

microorganism.

Oat protein concentrate is a vegan, non-GMO protein source and is a good source of certain essential 

amino acids. The petition also notes that it has better digestibility that other cereal proteins because it is 

primarily composed of globulin proteins. Additionally, due to its bland flavor and low impact on texture 

it can be used to supplement protein content in a wide range of foods. Examples listed in the petition 

include vegan entrees, cereal bars, baked goods, breakfast cereals, pasta, and meal replacement shakes. 

Overall oat protein concentrate appears to have no significant negative impacts on human health. 

Unlike other proteins used as supplements (milk, soy, egg), this ingredient can be used in foods targeted 

for individuals with these specific allergies. 

The petition states that oat protein concentrate is used in handling, not crop production, and therefore

it has no effect on soil, crops, or livestock. However, the Subcommittee would like to point out that 

according to the USDA pesticide data program there are 7 pesticide residues found on conventionally 

grown oats. Conventionally grown oats are what oat protein concentrate is derived from. 

The petition states that currently there is no source of organic oat protein concentrate, despite organic 

oats and organic oat bran being widely available in the U.S. and Canada. Additionally the petition claims 

that in Nordic countries, where a large amount of oat protein concentrate is manufactured, organic oat 

quantities are limited. The petition goes on to state that if the demand for organic oat protein 

concentrate was to increase, the Nordic manufacturing facilities could purchase organic oats from the 

U.S. The petitioner thought this scenario was unlikely to happen anytime soon due to the undetermined 

demand for oat protein concentrate in organic form. 

Summary of Review:

The Handling Subcommittee would like to point out that geographical location is not sufficient 

justification for arguing the commercial non-availability of a commodity. The Subcommittee sees no 

reason why oat protein concentrate could not be manufactured organically. Therefore, the 

Subcommittee recommends that the petitioned material, oat protein concentrate, should not be placed 

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on the National List as it fails the “Essentiality & Availability” criteria, as well as the “Commercial Supply 

is Fragile or Potentially Unavailable as Organic” criteria.

Category 1: Classification 

1. Substance is for: Handling

2. For HANDLING use: 

a. Is the substance agricultural or non-agricultural? Substance is agricultural

 Describe reasoning for this decision using NOP 5033-2 as a guide: 

Oat protein concentrate is extracted from whole oats. The oats are first de-hulled and then the oat 

bran and oat flour are separated through a dry milling process. Then the oat bran goes through a 

wet milling process, and using alpha-amylase enzyme the protein is separated from the bran. 

The oat protein remains intact throughout the manufacturing process. The protein is isolated 

through grinding, heating, and water extraction. No synthetic chemicals additions or solvents are 

used. 

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)]

N/A

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)]

N/A

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

N/A

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]. 

Oat protein concentrate can be used to boost protein in content in foods that are suitable for 

vegetarians, vegans, and those will allergies to milk, soy, wheat or celiac disease. 

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 final substance does not have a direct effect on soil, but the conventional oats from which 

the oat protein concentrate is extracted, could. According to the USDA pesticide data program 

there are 7 pesticide residues found on conventionally grown oats. 

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6. Are there any adverse impacts on biodiversity? (§205.200) 

The final substance does not have a direct effect on soil, but the conventional oats from which 

the oat protein concentrate is extracted, could. According to the USDA pesticide data program 

there are 7 pesticide residues found on conventionally grown oats. 

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)]

The alternative to using the substance would be to create an organic oat protein concentrate 

from organic oats. Additionally, there are other organic vegan proteins available on the market, 

for example: soy, hemp, pea, rice, quinoa, sunflower, pumpkin, mushroom, chia, amaranth,

lentil, flax, goji, and peanut. 

2. For Livestock substances, and Nonsynthetic substances used in Handling: In balancing the 

responses to the criteria above, is the substance compatible with a system of sustainable 

agriculture? [§6518(m)(7)]

No. 

Category 4: Additional criteria for synthetic substances used in Handling (does not apply to 

nonsynthetic or agricultural substances used in organic handling): 

N/A. Oat protein concentrate is agricultural 

Describe how the petitioned substance meets or fails to meet each numbered criterion.

1. The substance cannot be produced from a natural source and there are no organic substitutes; 

(§205.600(b)(1)) 

2. The substance's manufacture, use, and disposal do not have adverse effects on the environment 

and are done in a manner compatible with organic handling; (§205.600(b)(2)) 

3. The nutritional quality of the food is maintained when the substance is used, and the substance, 

itself, or its breakdown products do not have an adverse effect on human health as defined by 

applicable Federal regulations; (§205.600(b)(3)

4. The substance's primary use is not as a preservative or to recreate or improve flavors, colors, 

textures, or nutritive value lost during processing, except where the replacement of nutrients is 

required by law; (§205.600(b)(4)) 

5. The substance is listed as generally recognized as safe (GRAS) by the Food and Drug 

Administration (FDA) when used in accordance with FDA's good manufacturing practices (GMP) 

and contains no residues of heavy metals or other contaminants in excess of tolerances set by 

FDA; (§205.600(b)(5)) 

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Yes, oat protein is GRAS. Designated GRN No. 000575

6. The substance is essential for the handling of organically produced agricultural products. 

(§205.600(b)(6)) 

7. In balancing the responses to the criteria in Category 4, is the substance compatible with a 

system of sustainable agriculture [§6518(m)(7)] and compatible with organic handling? (see 

NOSB Recommendation, Compatibility with Organic Production and Handling, April 2004) 

Category 5: Additional criteria for agricultural substances used in handling (review of commercial 

unavailability of organic sources): 

1. Is a comparative description given as to why the non-organic form of the material /substance is 

necessary for use in organic handling provided? 

Yes, but not persuasive. 

2. Does the current and historical industry information, research, or evidence provided explain 

how or why the material /substance cannot be obtained organically in the appropriate form to 

fulfill an essential function in a system of organic handling?

No. 

3. Does the current and historical industry information, research, or evidence provided explain 

how or why the material /substance cannot be obtained organically in the appropriate quality to 

fulfill an essential function in a system of organic handling?

No.

4. Does the current and historical industry information, research, or evidence provided explain 

how or why the material /substance cannot be obtained organically in the appropriate quantity 

to fulfill an essential function in a system of organic handling?

The petition claims that in Nordic countries, where a large amount of oat protein concentrate is 

manufactured, organic oat quantities are limited. The Nordic manufacturing facilities could 

purchase organic oats from the elsewhere, if they determined the demand for organic oat protein 

concentrate was sufficient for justifying manufacture of the substance. Additionally, the 

subcommittee believes there are organic oats available in Europe. 

5. Does the industry information about unavailability include (but is not limited to) the following:

Regions of production (including factors such as climate and number of regions);

a. Number of suppliers and amount produced;

No. 

b. Current and historical supplies related to weather events such as hurricanes, floods, and 

droughts that may temporarily halt production or destroy crops or supplies;

No. 

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c. Trade-related issues such as evidence of hoarding, war, trade barriers, or civil unrest that 

may temporarily restrict supplies; or

No. 

d. Other issues which may present a challenge to a consistent supply?

No. 

6. In balancing the responses to the criteria in Categories 2, 3 and 5, is the substance compatible 

with a system of sustainable agriculture [§6518(m)(7)] and compatible with organic handling? 

(see NOSB Recommendation, Compatibility with Organic Production and Handling, April 2004) 

No. The Handling Subcommittee sees no reason why an organic form of oat protein concentrate 

could not be produced. Additionally, oat protein concentrate does not appear to be necessary in 

organic handling. 

Classification Motion: 

Motion to classify oat protein concentrate as petitioned as agricultural. 

Motion by: Lisa de Lima

Seconded by: Tom Chapman

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

Listing Motion: 

Motion to add oat protein concentrate as petitioned at §205.606 

Motion by: Lisa de Lima

Seconded by: Scott Rice 

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

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National Organic Standards Board

Handling Subcommittee Proposal

Additional listing of Tocopherols at §205.605(a) 

September 14, 2016

Summary of Proposed Action:

The Handling Subcommittee proposes an additional listing of Tocopherols at §205.605(a) of the National 

List.

Subcommittee Review 

Tocopherols are listed at §205.605(b) of the National List with the following annotation: Derived from 

vegetable oil when rosemary extracts are not a suitable alternative. 

Tocopherols function as antioxidants in foods, helping to preserve them and prevent rancidity. They are 

commonly extracted from distillates of vegetable oils. The term “tocopherols” refers to structurally 

similar compounds that occur in nature in four forms: alpha-, beta-, gamma-, and delta-tocopherol. 

Tocopherols that are derived from plant products are often referred to as “mixed tocopherols” because 

the mixture contains all four forms of tocopherol (CIR, 2002) (TR lines 41-43). 

Tocopherols are separated from other compounds in vegetable oil distillate by multiple extraction and 

refining steps. These steps can include solvent extraction, chemical treatment, crystallization, 

complexation, and vacuum or molecular distillation (Burdock, 1997; EFSA, 2008; Torres et al., 2011) (TR 

lines 87-89). Using the draft Classification of Materials guidance from the NOP, even tocopherols 

derived from natural sources could be considered synthetic, depending upon their extraction and 

refining processes.

The NOSB completed review of tocopherols as part of its 2017 Sunset review and voted at the Fall 2015 

meeting in Stowe, Vermont, to retain the listing on the National List at §205.605(b). However, during 

the initial public comment period, several commenters asserted that non-synthetic tocopherols are 

commercially available and should be used instead of synthetic versions. In the final Sunset proposal for 

tocopherols, the Handling Subcommittee indicated that it was considering a proposal to reclassify 

tocopherols to §205.605(a) and was seeking input regarding the impact of that on the industry. The 

second round of public comments brought forth several objections to a reclassification of tocopherols, 

citing their importance in food safety and voicing concerns regarding commercial availability of nonsynthetic versions. 

The Handling Subcommittee strongly encourages industry to move to non-synthetic, organic versions of 

tocopherols but does recognize that at present, there is insufficient commercial availability of organic 

tocopherols. For that reason, we are proposing a duplicate listing at 205.605(a) so that those 

manufacturers who wish to move to non-synthetic tocopherols – while waiting on commercial 

availability of organic versions – are incentivized to do so. 

Determination of Synthetic/Non-synthetic Status of Tocopherols

In March, 2013, the National Organic Program issued draft guidance on the classification of materials 

used in Organic production in the document NOP 5033 - Classification of Materials. Background Section 

3.1 states: “The Organic Foods Production Act of 1990 (OFPA) authorizes the USDA to establish the 

National List of Allowed and Prohibited Substances (National List). The National List is implemented in 

the USDA organic regulations at 7 CFR 205.600-607. 

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Under the OFPA, the National List must contain an itemization of each synthetic substance that is 

permitted and each natural substance that is prohibited for organic production. Due to this unique 

construction of the National List, definitions and classification are important to determine whether a 

substance is allowed or prohibited in organic production, whether it needs to be included on the 

National List, and where on the National List it should be placed. “ 

“For the handling or processing of organic agricultural products, the National List includes a list of 

agricultural and nonagricultural substances which are allowed in the handling of organic agricultural 

products. Nonagricultural substances are differentiated as either nonsynthetic (natural) or synthetic. 

Thus, the proper determination of a substance as agricultural or nonagricultural, or as synthetic or 

natural is important for proper placement on the National List.” 

Section 4.3 under Inputs for Organic Processing and Handling, NOP 5033 states: “Petitioned ingredients 

and processing aids for handling and processing are classified by the NOSB to determine placement of 

substances on the National List, sections 205.605-205.606. Substances must first be classified as 

agricultural or nonagricultural according to the classification decision tree, NOP 5033-2. Nonagricultural 

substances should be further classified as nonsynthetic or synthetic to determine placement on section 

§205.605(a) or §205.605(b), respectively.” 

Section 4.6, Extraction of Non-Organic Materials, provides direction on the extraction of distillates such 

as those used in the creation of tocopherols: “For purposes of classification of a material as synthetic or 

nonsynthetic, a material may be classified as nonsynthetic (natural) if the extraction or separation 

technique results in a material that meets the following criteria: 

• At the end of the extraction process, the material has not been transformed into a different 

substance via chemical change;

• The material has not been altered into a form that does not occur in nature; and

• Any synthetic materials used to separate, isolate, or extract the substance have been removed from 

the final substance (e.g., via evaporation, distillation, precipitation, or other means) such that they 

have no technical or functional effect in the final product. 

While draft guidance NOP 5033 on classification of materials has not been finalized, the decision tree, 

NOP 5033-2 , as published on April 27, 2013, will be used to determine the non-synthetic/synthetic 

status of tocopherols until such time as NOP guidance may be finalized. 

Vote in Subcommittee

Motion to list Tocopherols at §205.605(a) of the National List. Tocopherols – derived from vegetable oil

 

Motion by: Scott Rice

Seconded by: Jean Richardson

Yes: 8 No: 0 Abstain: 0 Absent: 1 Recuse: 0

Approved by Harold Austin, Subcommittee Chair, to transmit to NOSB on September 6, 2016.

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National Organic Standards Board

Handling Subcommittee Proposal

Annotation change for the listing of Tocopherols at §205.605(b) 

September 14, 2016

Summary of Proposed Action:

The Handling Subcommittee proposes to eliminate the annotation of the listing of Tocopherols at 

§205.605(b) of the National List: “Derived from vegetable oil when rosemary extracts are not a suitable 

alternative.” 

Subcommittee Review 

Tocopherols are listed at §205.605(b) of the National List with the following annotation: “Derived from 

vegetable oil when rosemary extracts are not a suitable alternative.” 

The NOSB completed review of tocopherols as part of its 2017 Sunset review and voted at the Fall 2015 

meeting in Stowe, Vermont to retain the listing on the National List at 205.605(b). However, during the 

initial public comment period, several commenters asserted that non-synthetic tocopherols are 

commercially available and should be used instead of synthetic. In the final Sunset proposal for 

tocopherols, the Handling Subcommittee indicated that it was considering a proposal to reclassify 

tocopherols to §205.605(a) and was seeking input regarding the impact of that on the industry, however, 

the second round of public comments brought forth several objections to any reclassification of 

tocopherols, citing their importance in food safety and voicing concerns regarding commercial availability 

of non-synthetic versions. 

Because the Handling Subcommittee strongly encourages industry to move to the use of non-synthetic, 

organic versions of tocopherols but does recognize that at present, there is insufficient commercial 

availability of organic tocopherols, the Subcommittee recently voted to send to the full NOSB a proposal to 

create an additional listing for tocopherols at §205.605(a) of the National List. That proposal duplicated the 

listing at 205.605(b) but with the annotation modified to state: “Derived from vegetable oil.” Public 

comment in the earlier Sunset review of tocopherols indicated that rarely is rosemary extract used as an 

alternative. Further, because the current annotation does not specify that rosemary extract must be 

organic, the subcommittee felt that part of the annotation should be eliminated. In order to have 

consistency between the listings at §205.605(ab) and §205.605(b), and to eliminate confusion among 

producers and certifiers, the subcommittee is proposing to eliminate that part of the current annotation at 

§205.605(b). But, to ensure that the source of tocopherols is limited and not randomly open to “any” 

synthetic tocopherol we are recommending to keep “Derived from vegetable oil” as part of both listings for 

consistency.

As stated in the proposal for the new listing at §205.605(a), while the draft guidance on classification of 

materials (NOP 5033) has not been finalized, the decision tree, NOP 5033-2, as published on April 27, 2013, 

will be used to determine the non-synthetic/synthetic status of tocopherols until such time as NOP 

guidance may be finalized. 

Vote in Subcommittee

Motion to amend the annotation for tocopherols listed at §205.605(b) of the National List to read as 

follows: Tocopherols – Derived from vegetable oil. 

Motion by: Tracy Favre

Seconded by: Ashley Swaffar

Yes: 8 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

Approved by Harold Austin, Subcommittee Chair, to transmit to NOSB on September 12, 2016.

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National Organic Standards Board

Handling Subcommittee

Cumulative impact of phosphates in organic processed foods

Discussion Document 

August 16, 2016

I INTRODUCTION

Recent research indicates that phosphate intake has increased dramatically in the general population due 

to widespread use of phosphate food additives in processed foods in the United States. Consumers may be 

unaware of phosphorous levels when reading labels on products because phosphorous may not be 

disclosed on the nutrition panel. Phosphorous is an essential nutrient and deficiency is extremely rare. 

However, high levels of phosphates can result in a range of human health problems.

Outside the US and Canada, the only phosphate additive allowed in organic processed food is monocalcium 

phosphate, and only as a leavening agent.

During Sunset Review in 2015 the Handling subcommittee received public comment which included new 

research indicating potential serious human health impacts from the cumulative effects of phosphates 

which are added to processed foods. The NOSB evaluated the substances according to the criteria in OFPA, 

especially with regards Criteria 4, 6, and 7, and with reference to CFR 205.600(b) especially with regard 3 

and 4. There was inadequate data to implicate any single phosphate, or any individual food item, as an 

isolated risk factor and thus the NOSB did not recommend that any of the phosphates be removed from the 

National List at Sunset. However the cumulative impact of these ingredients or processing aids remains an 

issue which merits further Discussion. 

This Discussion Document outlines the issues and seeks public comment to determine the range of use of 

phosphates in organic processed foods, the extent to which they are really necessary, and to seek 

additional new medical and nutrition research on the human health impacts of these additives and their 

cumulative impact. 

If public comment and associated research finding indicate need for further action, the NOSB may 

recommend increased restrictions through annotations or removal of phosphate food additives. 

II BACKGROUND

In 2015, during its Review of Sunset 2017 materials, the NOSB received public comment, based on recent 

scientific research, raising concerns about the cumulative negative impact of phosphate food additives. 

In July 2015, because several of the phosphates on the National List had not been fully reviewed in formal 

Technical Reports (TR), the NOSB requested a comprehensive TR to cover all the Phosphates, with 

particular emphasis on cumulative health impacts. The NOSB received this Technical Evaluation Report (TR) 

in February 2016. This TR did not include Tetrasodium pyrophosphate because a 2002 TR was already 

available and the material had been voted to be removed from the national list in April 2015. 

The February 2016 TR presented a range of issues of concern which are further discussed below. However, 

at its October 2015 meeting in Stowe Vermont, while acknowledging the cumulative negative health 

impacts of phosphates, the NOSB voted to continue to list the phosphate materials as there was insufficient 

research to indicate that the tiny amounts of any one phosphate additive alone, as an isolated risk factor,

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was sufficient to suggest removal from the List. The NOSB members and public comment indicated need for 

further discussion of this issue.

III RELEVANT AREAS OF THE RULE

Phosphate salts are allowed under the National Organic Program (NOP) Regulations at:

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)).” 

The following nonagricultural substances may be used as ingredients in or on processed products 

labeled as “organic” or “made with organic (specified ingredients or food group(s))” only in 

accordance with any restrictions specified in this section. 

205.605(b) Synthetics allowed: 

Calcium phosphate (monobasic, dibasic, and tribasic).

Potassium phosphate- for use only in agricultural products labeled “made with organic (specific 

ingredients or food group(s),” prohibited in agricultural products labeled “organic”.

Sodium acid pyrophosphate (CAS # 7758-16-9) –for use only as a leavening agent.

Sodium phosphates – for use only in dairy foods.

Tetrasodium pyrophosphates – (CAS # 7722-88-5) for use only in meat analog products. (This 

material was recommended by the NOSB, April 2015, for Removal from the National List and is 

presently in rulemaking). 

The Organic Foods Production Act (OFPA) requires that the NOSB evaluate each substance according to 7 

criteria as specified in 7 USC Section 6518(m) of the Act. The criteria of particular relevance to this 

discussion are:

 (4) The effect of the substance on Human Health, and

 (6) The alternatives to using the substance in terms of practices or other available materials and 

(7) Compatibility with a system of sustainable agriculture.

In addition, CFR Section 205.600 (b) requires that any synthetic substance used as a processing aid or 

adjuvant will be evaluated against 6 additional criteria, where criteria 3, 4, 5, and 6 are particularly relevant 

to this discussion:

(1) The substance cannot be produced from a natural source and there are no organic substitutes;

(2) The substance's manufacture, use, and disposal do not have adverse effects on the environment 

and are done in a manner compatible with organic handling;

(3) The nutritional quality of the food is maintained when the substance is used, and the substance, 

itself, or its breakdown products do not have an adverse effect on human health as defined by 

applicable Federal regulations;

(4) The substance's primary use is not as a preservative or to recreate or improve flavors, colors, 

textures, or nutritive value lost during processing except where the replacement of nutrients is 

required by law;

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(5) The substance is listed as generally recognized as safe (GRAS) by Food and Drug 

Administration (FDA) when used in accordance with FDA's good manufacturing practices (GMP) and 

contains no residues of heavy metals or other contaminants in excess of tolerances set by FDA; and

(6) The substance is essential for the handling of organically produced agricultural products.

IV DISCUSSION

1). Technical Reports: 

It is clear that the NOSB has expressed concern about the health impacts of phosphates for a number of 

years, and requested several Technical Reports (TR), Technical Evaluation Reports (TR), and Technical 

Advisory Panel Reports (TAP). These reports have consistently included concerns for human health. The 

following TR and TAP are incorporated by reference herewith: 

Calcium phosphate: TAP 1995 and TR Phosphates Feb 10, 2016; 

Potassium phosphate: TAP 1995 and Phosphates TR Feb 10, 2016; 

Sodium acid pyrophosphate: Sodium phosphates TAP Sept. 21, 2001, and SAP TR Sept 17, 2010 for rejected 

petition for expanded use in 2010, and Phosphates TR Feb 10, 2016; 

Sodium phosphates: TAP Sept 21, 2001 and TR Phosphates Feb 10, 2016; 

Tetrasodium pyrophosphate: TAP July 29, 2002; Limited scope TR June 9, 2014;

Note: These substances are also bioavailable sources of the nutrients calcium, phosphorus, potassium and 

sodium, and all but one are allowed by FDA as nutrient supplements in foods. However, their use as 

nutrient sources in foods labeled as organic is the subject of a separate Technical Report for Nutrient 

Vitamins and Minerals in 2015. 

2). Uses of phosphate additives in processed products: 

Phosphates are common additives found in many processed foods to increase shelf life, thicken, aid in 

gelling, stabilize, texturize, pH buffer, leavening etc. In recent years, as production of processed organic 

foods has increased, processors who typically produce non-organic foods, simply used some of the same 

additives as they expanded their production into organic. The result is widespread use of phosphate 

additives in organic processed foods.

(a) Phosphates in Organic foods 

A survey and sampling of grocery stores in the Cleveland, Ohio area found that 44% of the best-selling 

grocery items contained phosphorus additives. The additives were particularly common in prepared 

frozen foods (72%), dry food mixes (70%), packaged meat (65%), bread and baked goods (57%), soup 

(54%), and yogurt (51%) categories. 

Some companies produce the same or essentially the same organic product both with and without 

added phosphates. For example : Kraft Macaroni & Cheese DinnerTM is “organic” with added phosphate, 

and Kraft Organic Cheddar Macaroni & Cheese DinnerTM is produced without added phosphate. 

Phosphorus additive-containing foods averaged 67 mg phosphorus per 100 g more than matched nonadditive containing foods. Sample meals comprised mostly of phosphorus additive-containing foods 

had 736 mg more phosphorus per day compared to meals consisting only of additive-free foods. 

Phosphorus additive-free meals cost an average of $2.00 more per day (Leon, Sullivan, and Sehgal 

2013) (TR 2016 lines 678-687)

Due to the present annotations on phosphate use in organic foods, it would be expected that basing a 

diet on organic foods would reduce the phosphorus intake. De Lorenzo et al. (2010) compared those 

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who ate an ”Italian Mediterranean Organic Diet” to participants who followed a similar diet with 

phosphate additives and found reduced serum homocysteine and phosphorus levels, reduced 

microalbuminuria, and reduced cardiovascular disease risk in healthy individuals and in those with 

Chronic Kidney Disease (CKD). The results of this European trial cannot be extrapolated to the U.S. 

without some reservations. The EU organic regulations allow addition of only one phosphate, 

monocalcium phosphate, which can only be used as a leavening agent, whereas USDA organic 

regulations allow sodium pyrophosphate for this purpose and several other phosphates for other uses. 

These differences could be important, since Karp et al. (Karp, Ekholm, Kemi, Itkonen, et al. 2012) found 

that the conventional cereal product with the highest total phosphate content (216 mg/100 g), all of 

which was digestible, was industrial muffins that contained sodium acid pyrophosphate as the 

leavening agent. (TR 2016, 665-676)

(b) Specific phosphates and their uses.

Calcium phosphate (monobasic, dibasic, and tribasic).

Calcium phosphates are used in conventional foods as leavening agents, dough strengtheners and 

conditioners, nutrients, malting or fermenting aids and yeast foods (all three forms); the monobasic 

form is used as a buffer, firming agent and sequestrant; tribasic is used as an anticaking agent or 

free-flow agent, buffer or pH control agent, thickener or stabilizer. The NOP regulations at 7 CFR 

205.605(b) do not impose additional restrictions on the use of calcium phosphates in processed 

organic foods. Tricalcium phosphate is commonly used in organic non-dairy beverages (soy ‘milk’, 

almond ‘milk’, orange juice, etc.) to provide the nutrients calcium and phosphorus. Dicalcium 

phosphate is the inert diluent and carrier for Vitamin B12 in fortified organic foods. Monocalcium 

phosphate is used as a component of chemical leavening agents (“baking powder”). Tricalcium 

phosphate is commonly used in non-dairy beverages as a source of calcium since these beverages 

displace cows’ milk from the diet. Organic orange juice that is calcium-fortified contains tricalcium 

phosphate. Some organic yogurts and some non-dairy yogurt-like foods also contain tricalcium 

phosphate. Without this calcium fortification, these non-dairy beverages would be practically 

devoid of calcium.

Potassium phosphate- for use only in agricultural products labeled “made with organic (specific 

ingredients or food group(s),” prohibited in agricultural products labeled “organic”.

Potassium phosphate is used as a pH control agent in milk products, as a nutrient supplement, 

sequestrant and emulsifier, a malting or fermentation aid, and a stabilizer and thickener. 

Dipotassium phosphate is the only form of potassium phosphate cited by FDA for use in pasteurized 

process cheese (21 CFR 133.169) and pasteurized process cheese food (21 CFR 133.173). 

Sodium acid pyrophosphate (CAS # 7758-16-9) –for use only as a leavening agent.

Sodium acid pyrophosphate is used in conventional foods as a chemical leavening agent in baked 

goods; a sequestrant (chelating agent) to maintain the appearance of cooked and uncooked fruits 

and vegetables, particularly processed potatoes; an emulsifying agent and stabilizer in cheeses and 

related products; an inhibitor of struvite1 formation in canned tuna; and a curing accelerator in 

processed meat and poultry products. 

Sodium phosphates – for use only in dairy foods.

Sodium phosphates are used in conventional foods as pH control agents and buffers, sequestrants, 

texturizers and nutrients. Monobasic sodium phosphate is used as an acidulant. Some organic 

products containing cheddar cheese, such as cheese crackers or macaroni and cheese, may contain 

organic cheddar cheese with added sodium phosphate.

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Tetrasodium pyrophosphates – (CAS # 7722-88-5) for use only in meat analog products

Tetrasodium pyrophosphate (TSPP) is used as a synthetic food additive in the manufacture of meat 

substitutes (analogs) serving a number of purposes that compensate for insufficient gelling 

requirements. The effects of TSPP are to improve texture, adjust pH, act as a pH buffer, and reduce 

cooking loss. This material has been recommended for Removal from the National List

3). Approved Legal Uses of the Substance: 

Each of the phosphate salts listed in the NOP regulations at 7 CFR 205.605(b) is identified by FDA in 21 CFR 

182 as “Generally Recognized As Safe” (GRAS) for use in food for the various purposes shown below in 

Table 4 of the TR 2016. The only potassium phosphate salt that is the subject of a GRAS citation as a food 

ingredient is dipotassium phosphate. Nevertheless, monopotassium phosphate is permitted in frozen eggs 

(21 CFR 160.110(b)), and all of the potassium phosphates (mono-, di- and tripotassium) are GRAS for 

incidental food use in adhesives in articles intended for use in packaging, transporting or holding food (21 

CFR 175.105). The USDA Food Safety Inspection Service (FSIS) permits both monopotassium phosphate and 

dipotassium phosphate in certain meat- and poultry-containing products (9 CFR 318.7 and 9 CFR 424.21). 

FDA permits addition of sodium phosphates by name as an optional ingredient in several classes of dairy

foods: pasteurized process cheese (21 CFR 133.169); pasteurized process cheese food (21 CFR 133.173);

pasteurized process cheese spread (21 CFR 133.179); ice cream and frozen custard (21 CFR 135.110); and

frozen eggs (21 CFR 160.110). The generic optional ingredient designation “stabilizer,” which frequently is

sodium or potassium phosphate, is permitted in a variety of dairy foods, such as acidified milk (21 CFR 131 

131.111), cultured milk (21 CFR 131.112), evaporated milk (21 CFR 131.130), heavy cream (21 CFR 131.150),

light cream (21 CFR 131.155), light whipping cream (21 CFR 131.157), eggnog (21 CFR 131.170), yogurt (21 

133 CFR 131.200), and cream cheese (21 CFR 133.133). 

Because most dairy foods naturally contain substantial amounts of both sodium and phosphorus from the 

milk, the small incremental amount of sodium and phosphorus contributed by a sodium phosphate

stabilizer may exempt sodium phosphate from the requirement to be declared as an ingredient on the 

label. This practice is allowed by FDA at 21 CFR 101.100(a)(3)(ii)(b). The only FDA-regulated foods where 

this exemption from labeling is not permissible are hypoallergenic foods (21 CFR 105.62) and infant foods 

(21 CFR 105.65). 

FSIS also requires labeling of all food additives for meat products. Thus, the absence of sodium phosphate 

from the ingredient declaration of an FDA-regulated food does not necessarily mean that this substance has 

not been added to the food. 

FSIS regulates meat- and poultry-containing foods and is responsible for determining the suitability of FDAapproved substances in meat and poultry products. FSIS lists allowed food ingredients at 9 CFR 318.7 and 9 

CFR 424.31. Phosphates, including sodium acid phosphates, trisodium phosphate, and mono- and 

dipotassium phosphates, are allowed at 9 CFR 319.180 in a variety of prepared meat-containing foods, 

particularly cooked sausage, which includes frankfurter, frank, hotdog, weiner, vienna sausage, bologna, 

knockwurst and similar products. 

The NOP regulations at 7 CFR 205.605(b) restrict the use of sodium phosphates to organic dairy products 

only, so added phosphates are not permitted in prepared organic meat products .

4). International:

The Canadian Organic Standards align with the NOP regulations with regard to phosphates and the 

restrictions on their use. In contrast, the CODEX Guidelines, the European Regulation, the Japanese 

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Agricultural Standard and the IFOAM norms only allow monocalcium phosphate and only for use as a 

leavening agent. 

5). Nutritional Value of Food (TR 2016 lines 346-405):

An important nutritional consideration of a diet is its calcium-to-phosphorus (Ca:P) ratio. During periods of 

rapid skeletal growth, such as in infancy, the dietary calcium-to- phosphorus ratio should not fall below 1.0. 

The FDA infant formula regulation (21 CFR 107.100(e)) requires a Ca:P ratio not less than 1.0 and not more 

than 2.0. In later life, calcium metabolism is closely regulated by Vitamin D metabolites, particularly 

calcitriol. High levels of blood phosphorus suppress the formation of calcitriol (Institute of Medicine 1997). 

The dangers of too much dietary phosphate include excessive bone loss and other effects. 

The nutrient phosphorus is not subject to mandatory listing in the Nutrition Facts of a food label (21 CFR 

101.9(c)(8)(ii)), and the ingredient declaration may not declare an added phosphate if exempted by 21 CFR

101.100(a)(3)(ii)(b). Consequently, ‘silent’ addition of phosphates as functional additives can alter the Ca:P 

ratio of food, and thus the diet, without the consumer being aware of the fact. 

Sodium and potassium are two electrolyte minerals essential to life. Sodium and potassium interact

nutritionally. Potassium salts are more expensive than their sodium counterparts, and potassium has a 

greater molecular weight than sodium, so a greater weight of potassium salts must be added. For these

reasons, sodium phosphates are used far more frequently than are potassium phosphates in any

application where the two are functionally interchangeable. However, since our diets in general provide

much less potassium than is advised and much more sodium than is advised, using the potassium salt 

would be nutritionally advantageous. Note that sodium chloride (table salt) is the primary source of sodium 

in the diet and a much greater contributor of sodium to the American diet than the sodium phosphates 

(Institute of Medicine 2005).

6). Effects on Human Health: (see TR 2016 lines 438-687 and citations)

Phosphorus interacts with other mineral elements, particularly calcium, magnesium and potassium, in bone 

formation, kidney function, and other physiological processes. Understanding this interaction is important 

for understanding the effects of phosphates on human health and nutrition. The Ca:P ratio of a diet is 

important. The relation of these two well-known minerals to the lesser studied mineral magnesium is also 

important. Sodium also interacts with these mineral nutrients, particularly potassium.

The National Health and Nutrition Examination Survey (NHANES) is a program of studies designed to 

continuously assess the health and nutritional status of adults and children in the United States. The survey 

is unique in that it combines interviews and physical examinations and provides a correlation of nutrient 

intakes with health as well as socioeconomic status. The NHANES data provides a foundation base but it is 

understood that total phosphorus intake may be much higher.

The NHANES data on phosphorus, sodium, calcium and magnesium, and potassium intakes for adult 

American (~20 to ~50 years of age), compared to the dietary reference intakes for these nutrients, indicate 

the following for phosphorus: 

Phosphorus: The Estimated Average Requirement (EAR) for adult men and women is 580 mg per day. The 

Recommended Dietary Allowance (RDA) is 700 mg per day and the Tolerable Upper Intake Level (UL) is 

4000 mg per day (Institute of Medicine 1997). Mean daily intakes were reported as 1701 mg for men (243% 

of the RDA) and 1179 mg for women (168% of the RDA). The average intake of women in the lowest 

quartile of phosphorus intakes was reported as 671 mg per day, 15% greater than the EAR (Lee and Cho 

2015). (TER, 2016, 464-469)

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An analysis of NHANES data found that, after adjusting for demographics, cardiovascular risk factors, kidney 

function, and energy intake, a higher phosphorus intake was associated with higher all-cause mortality in 

individuals who consumed more than 1400 mg/day, but at intake levels less than 1400 mg/day, there was 

no association (Chang et al. 2014). Analysis of the NHANES data for individuals with moderate chronic 

kidney disease (“CKD”) found that high dietary phosphorus intakes were not associated with increased 

mortality in moderate CKD (Murtaugh et al. 2012). A higher phosphorus intake was associated with higher 

calcium intake and was positively associated with bone mineral content in female teenagers, and it was also 

positively associated with bone mineral content and bone mineral density, as well as reduced risk of 

osteoporosis, in adults over 20 years of age (Lee and 490 Cho 2015). (TER 2016, 480-490)

7). Health effects of phosphorus provided by phosphate additives versus natural phosphorus in foods. 

Elevated serum phosphate is a risk factor for certain diseases and disease outcomes. In healthy individuals,

higher serum phosphate levels have been associated with greater risk for end-stage renal disease and 

mortality (Sim et al. 2013; Dominguez et al. 2013), abnormally low blood circulation (Meng et al. 2010),

abnormally high arterial stiffness (Ix et al. 2009; Kendrick et al. 2010), increased risk of cardiovascular 

disease (Dhingra et al. 2007) and twice the risk of developing heart failure (Dhingra et al. 2010). Higher 

levels of serum phosphorus have also been shown to predict coronary artery disease development and 

progression (Tuttle and Short 2009).

Sodium and potassium phosphates and sodium acid pyrophosphate are very soluble in water. 

Consequently, the phosphorus in these additives, commonly referred to as “additive phosphorus,” is 

immediately and completely bioavailable upon consumption. In contrast, the phosphorus naturally present 

in most foods (“food phosphorous”) is much less available, in part due to the physical structure of the food 

and also because digestion of phosphate complexes may be required before the phosphorus can be 

absorbed. 

The digestibility of phosphorus in various foods has been estimated by in vitro studies (Karp, Ekholm, Kemi, 

Hirvonen, et al. 2012; Karp, Ekholm, Kemi, Itkonen, et al. 2012). Only 6% of the phosphorus in sesame seeds 

with intact hulls was found to be digestible. In legumes, where much of the phosphorus is present as 

phytate, the average in vitro phosphorus digestibility was 38%. In contrast, the “additive phosphorus” in 

cola drinks and beer was 87-100% digestible. In cereal products the highest total phosphorus content and 

digestibility were found in industrial muffins containing “additive phosphorus” in the form of sodium 

pyrophosphate as a leavening agent.

8). Summary: 

• The American diet provides very large amounts of phosphorus and sodium. 

• The published phosphorus content is not based on analysis, so the amount of phosphorus 

consumed is understated. 

• Half of the adult American population consumes less than the Estimated Average Requirement, EAR 

of magnesium and essentially no one nowadays consumes the Adequate Intake, AI of potassium. 

• A substantial proportion of Americans, almost 40%, consume less than the EAR of calcium (Fulgoni 

et al. 2011). 

• The major mineral content of the adult American diet is severely imbalanced. 

• It is difficult to fully asses the health impacts of phosphate additives in processed organic foods, in 

part because scientific research typically focuses on one aspect of one material at a time. This 

allows the specific question posed in the research to be answered, but rarely allows for an 

understanding of the synergistic effects or cumulative impacts over time. A comprehensive metaanalysis may provide greater insight.

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• Consumers typically do not calculate the total intake of every material as they eat their standard 

diet, both organic and conventional, processed or unprocessed, and often take additional mineral 

or nutritional supplements.

• The phosphate in phosphate additives is highly bioavailable and more potent for increasing blood 

phosphate levels than natural phosphate from food. 

• 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.

V REQUEST FOR PUBLIC COMMENT

The NOSB recognizes that although no single phosphate can be implicated as an isolated risk factor, it is 

clear that there are health implications from cumulative impact of phosphate additives in processed organic 

foods. 

Please provide answers to the following questions:

1. If some brands of organic processed dairy products can be produced without use of phosphates, 

why not all of them? What are the alternatives?

2. If European, Japanese, CODEX and IFOAM standards limit phosphates to only monocalcium 

phosphate – only as a leavening agent, why are all the other phosphates necessary in U.S organic 

food processing?

3. Should phosphate food additives in processed organic foods be phased out, and if so should just 

some of them be phased out or should it be allowed in only some products? 

Vote in Subcommittee

Motion to accept the discussion document on phosphates as written

Motion by: Jean Richardson 

Seconded by: Ashley Swaffar

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

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National Organic Standards Board

Livestock Subcommittee Discussion Document

Marine algae listings on National List

September 6, 2016

I INTRODUCTION

During its recent five year sunset review of almost 200 materials the NOSB noted that there are a number 

of materials listed that are either marine algae or extracts of marine algae. The National List includes 

overlap in species in the various material listings. Some of the materials listed lack a Technical Report (TR) 

which limited full review of all algal materials. Public comment during Sunset Review indicated serious 

concerns about the following:

• Conservation of wild marine algae 

species

• Overharvesting of some species in some 

geographic areas

• Need for clarification of which species are 

used, and from which geographic areas

• Need for clarification of which species 

can or are being cultivated

• Clarification of wild harvesting 

techniques

• Feasibility of harvesting by individual 

species selection as opposed to multispecies harvesting by littoral or marine 

zone

• Extraction methods

• Sequestration of metals or other 

contaminants in some wild algal species

Because of public comment the NOSB requested a limited scope TR to address these concerns. The TR 

was received on August 9, 2016. 

The goal of this discussion document is to present a brief analysis of our present understanding of the 9 

marine algae on the National List and request public comment. Depending on public comment the NOSB 

may develop a proposal to annotate some of the materials on the list, or clarify the naming convention 

used to list these marine materials because many of the naming conventions may be duplicative and 

redundant. Alternatively, the NOSB may recommend that the NOP provide further guidance on use of 

seaweeds in organic production. 

II BACKGROUND

Seaweeds have been commonly used, in many ways, throughout human history. They comprise a 

seemingly unlimited renewable resource subject, however, to the usual depletion through unintended 

over harvesting and pollution. Open oceans, tidal and intertidal zones appear to be relatively open to 

public harvesting. The laws that control harvesting, establish conservation zones and seek to ensure 

sustainable seaweed harvest, while protecting marine ecosystems worldwide, are highly variable, and 

typically poorly articulated and not easy to enforce.

 

In the face of exponentially growing pressure on marine resources, decline in fisheries, decline in 

species, decline in habitats, and depletion of seaweed species in many geographic areas, the European 

Commission in May 2016 held a conference to focus on Organic Seaweed Rules, Blue Growth and the 

Bioeconomy1

. The conference provided examples of good management in areas of high ecological 

quality which were not contaminated, and where environmental assessment and estimation of biomass 

was undertaken at the outset, and a sustainable management plan is in place. 

11 http://coastwatch.org/europe/wp-content/uploads/2016/05/Organic-Seaweed-Coastwatch.pdf

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However, most of the seaweed harvested for human use is not certified organic, but simply harvested 

from or cultivated in marine environments worldwide. Some marine environments are polluted by run 

off from terrestrial activities taking place over generations. Some seaweed species grow back very fast 

following harvest, while others take many years. Because of high demand, harvesting does not 

necessarily protect biomass and rarely involves ecosystem management. Little is really understood 

about the multi-tropic impact on seaweed harvesting or cultivation.

It is within this context of a desire to allow use of marine plants and algae in organic production, while 

at the same time ensuring long term sustainability, that the marine materials on the National List must 

be reviewed.

There are nine separate listings for marine materials on the National List which are the subject of this 

document: 

1. Aquatic plant extracts (TR 2006) - aquatic plant (algae) extracts are most commonly derived 

from kelp such as Ascophyllum species and Ecklonia maxima (Sea Bamboo) as well as other 

seaweeds harvested from the North Atlantic. Ascophyllum nodosum, (Rockweed) a species 

known to be overharvested in many geographic regions, is in the Fucaceae, a brown seaweed, 

Class Phaeophyceae – not able to be cultivated and known to be regionally overharvested.

2. Alginic acid (TR 2015) is primarily extracted from brown seaweeds, Class Phaeophyceae. Major

commercial sources are from species that include Ascophyllum (North Atlantic), Laminaria and 

Saccharina (various northern hemisphere oceans) and Macrocystis (California and Mexico), with 

lesser sources from Lessonia (South America), Durvilea (Australia), Ecklonia (South Africa), 

Sargassum, and Turbinaria. 

3. Agar-Agar (TR 2011) is typically derived from red seaweeds, Class: Rhodophyceae. The marine 

algae that produce agar-agar are widely distributed throughout the world and several different 

species are utilized for extraction. Most commercial agar-agar is extracted from Gelidium and 

Gracilaria species, but other commonly used species include Pterocladia and Gelidiella. The 

most important sources worldwide include the coasts of Japan, Spain, Portugal, Morocco, 

Senegal, Chile, Mexico, the southern United States, India, the Philippines, Madagascar, South 

Africa, Egypt, and New Zealand although many other countries also supply algae used to make 

agar-agar. Although most agar-agar is produced from algae that grow in the oceans, Gracilaria

algae are also cultivated on a commercial scale by some countries. 

4. Carrageenan (TR 2011) is a generic term for a family of linear polysaccharides derived from 

species of red seaweeds (Rhodophyceae). They can be wild harvested or cultivated. Typical 

species used are Chondrus crispus, Mastocarpus stellatus, Euchema cottonii and Eucheuma 

spinosum, which grow in the warm waters of the Philippines, Indonesia, and Tanzania and 

produce kappa- and iota-carrageenan, respectively. The Asia-Pacific region has remained the 

largest source of carrageen-producing seaweed, supplying over 50% of the market from 1999 

through 2009, and the Americas have similarly maintained 16-18% of the global market. 

5. Alginates are derived from brown seaweeds (See TR 2015). Of the species in the class of brown 

seaweeds, 41 species are used for extracting alginates, including: Ascophyllum nodosum from 

Ireland, Norway, UK; Cystoseira barbata from Egypt; Durvillaea potatorum from Australia; Fucus 

serratus, F. vesiculosus from Ireland; Laminaria digitata from France, Ireland; Laminaria 

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hyperborea from Ireland, Norway, Spain, UK; Laminaria japonica from China; Laminaria 

ochroleuca from Spain; Lessonia nigrescens from Chile, Peru; Lessonia trabeculata from Chile; 

Macrocystis integrifolia from Peru; Sargassum crassifolium, S. gramminifolium, S. 

henslowianum, S. mcclurei, S. siliquosum, S. vachelliannum fromVietnam; Sargassum ilicifolium, 

S. myriocystum, S. wightii, Turbinaria conoides, T. decurrens, T. ornata from India; Sargassum 

polycystum from Indonesia, Thailand.

6. Beta-carotene from algae (TR, 2011) is typically derived from green algae, Class: Chlorophyceae. 

The common source of beta-carotene color is derived from the micro-algae Dunaliella salina and 

Dunaliella bardawil. These species are cultivated. Dunaliella species are commonly observed in 

salt lakes in all parts of the world from tropical to temperate to Polar Regions where they often 

impart an orange-red color to the water. In a review article conducted by Dufosse et al. (2005), 

they concluded that algal forms are the richest source of pigments and can be produced in a 

renewable manner, since they produce some unique pigments sustainably. The report also 

stated that the production of β-carotene from Dunaliella will surpass synthetic as well as other 

natural sources due to microalgae sustainability of production and their renewable nature. (TR 

2011, 530-545).

The following 3 materials did not have detailed TRs until 2016:

7. Kelp is a broad generic term for brown seaweeds, Class Phaeophyceae, in the Order 

Laminariales, with at least 30 genera and many species, and in the Order Fucaceae such as

Ascophyllum nodosum. However the term “kelp” as used in fertilizer means ANY macroalgae 

seaweed, brown (Phaeophyceae), red (Rhodophyceae) or green (Chlorophyceae) (Assoc. of 

American Plant Food Controls (AAPFC)). Kelp used in organic livestock production must be 

certified organic, but for use in processing for humans non-organic kelp is allowed. Pacific 

Kombu, and Undaria innatifida are also Kelp species. Fucus species are intertidal, but Laminaria 

species are deep water.

8. Seaweed- Pacific Kombu is a kelp, often Laminaria japonica. This species is cultivated in waters 

of Japan, Korea and China. 

9. Wakame- Undaria pinnatifida is a kelp species native to cold temperate coastal waters in Japan, 

Korea and China, but it has also become an invasive weed species in numerous other locations.

Undaria is widely cultivated in China and Japan.

III RELEVANT AREAS OF THE RULE, NOP GUIDANCE, AND NOP MEMOS

§205.601 Synthetic substances allowed for use in organic crop production

In accordance with restrictions specified in this section, the following synthetic substances may be used 

in organic crop production: Provided that, use of such substances do not contribute to contamination of 

crops, soil, or water...

(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.

§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)).”

(a) Nonsynthetics allowed: 

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Acids (Alginic; ...). 

Agar-agar. 

Carrageenan. 

(b) Synthetics allowed:

Alginates. 

§205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed 

products labeled as “organic.” 

(d) Colors derived from agricultural products-must not be produced using synthetic carriers and 

solvent systems or any artificial preservative. 

(2) Beta-carotene extract color derived from carrots or algae (pigment CAS 1393-61-1). 

(l) Kelp – for use only as a thickener and dietary supplement.

(t) Seaweed, Pacific Kombu. 

(x) Wakame Seaweed (Undaria pinnatifida). 

§205.207 Wild-crop harvesting practice standard.

(a) A wild crop that is intended to be sold, labeled, or represented as organic must be 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 the harvest of the wild crop.

(b) A wild crop must 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.

NOP 5022, Guidance- Wild Crop Harvesting, effective July 22, 2011, provides details to clarify §§205-

207.

NOP Policy Memo 12-1, Production and Certification of Aquatic Plants, issued September 12, 2012 

provides further clarification, as follows:

This policy memorandum is issued as a reminder that aquatic plants and their products may be 

certified under the current USDA organic regulations. Certifiers and their clients may use the USDA 

organic regulations, including the National List of Allowed and Prohibited Substances at 7 Code of 

Federal Regulations (CFR) 205.601-205.602, as the basis for the production and certification of 

cultured and wild crop harvested aquatic plants. 

While current USDA organic regulations specifically exclude aquatic animals from organic 

certification, no such exclusion exists for aquatic plants. Further, some parts of the USDA organic 

regulations specifically address aquatic plant production. For example, some aquatic plants, such as 

kelps and seaweeds, are listed in 7 CFR 205.606 of the USDA organic regulations, allowing their use 

in non-organic form when certified organic forms are not commercially available. Producers and 

certifiers are required to comply with the USDA organic regulations when producing or certifying 

cultured and wild crop harvested aquatic plants. 

The use of ground and surface waters, ponds, streams, or other waterways for aquatic plant 

production may be regulated by Federal, State or local authorities. Aquatic plant producers should 

consult with Federal, State and local authorities to ensure compliance with all applicable laws, in 

addition to the USDA organic regulations, regarding the use of synthetic substances and other 

materials in ponds and waterways. Also, under 7 CFR 205.200, aquatic plant producers must ensure, 

and certifying agents must verify, that production practices maintain or improve the natural 

resources of the operation, including soil and water quality. 

IV DISCUSSION:

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The NOSB submitted brief information on each of the nine materials and posed seven questions to the 

NOP for the limited scope TR. This TR was received in August 2016 and the responses to these questions 

are briefly discussed below. The TR cited a number of references but the literature review was limited. 

Some additional relevant references are included in this discussion.

1. Nomenclature: Many of the National List listings are generic terms or overlapping terms lacking 

specificity, such as “agar-agar”, “carrageenan”, “aquatic plant extracts” or “kelp”. Should each 

listing include specific Latin names of approved algae? Should the word “plant” be replaced by the 

word “algae”?

The TR provides sources of marine polysaccharides (TR 2016, Table 3) but acknowledges the 

somewhat arbitrary nomenclature of red algae. Thus it may be possible for the NOSB to propose

some clarity in the listings through use of Latin names. However, it must be noted that taxonomic 

revision amongst algal species has become commonplace. Morphologically plastic species in the 

same geographical location and identical species in different geographic locations are frequently 

given different scientific names (TR 2011 631-634 and 689-716).

Habitat forming seaweeds include the Laminariales (Laminaria species and others) and Fucales

(Ascophyllum and others). Currently many of these species are referred to by a single common name 

“kelp”. This creates confusion because macroalgal species are harvested by different methods, their 

life histories and growth rates differ, and thus the impacts of cutting and harvesting on these species 

will differ. Clarification in naming conventions is thus of importance if conservation of habitat and 

species is taken into consideration.

2. Overharvesting: The nine listings include thousands of species of algae from many different 

geographic locations, the marine intertidal zone, deeper ocean areas, and wild harvested beds. 

Which species, genera, classes are being overharvested? Which geographic regions indicate 

overharvesting impact? What is the trend in harvesting marine algae? What is the present status 

and trends in harvesting and overharvesting of Ascophyllum nodosum?

The TR provides examples of the following seaweeds being overharvested: Irish Moss (Chondrus 

crispus), Rockweed (Ascophyllum nodosum) and giant Kelp (Macrcustis pyrifera). It must also be 

noted that ocean warming and other environmental factors probably contribute to depletion of 

these species (see also: Halat et al, 20152

; Kay et al, 2016.

3

). Overharvesting impacts not only the 

specific plant species or genus, but all the associated plant and animal species that form the marine 

ecosystem in a given location. (see also Keats et al 19874 and Kelly, 20055

There is limited evidence to suggest that the harvesting of agarophytes (algae used to make agaragar) may be harmful to biodiversity. The current world demand for agar-agar is reportedly 

increasing, which has placed pressure on the overharvested natural sources. Overharvesting of 

many wild Gracilaria strands has resulted in the destruction of some of the larger genetic reserves 

2

Laryssa Halat, Moira E Galway, Sara Gitto and David Garbary, Epidermal shedding in Ascophyllum nodosum

(Phaeophycea): seasonality, productivity and relationship to harvesting. Phycology, Vol.54(6), 599-608, 2015. 3 Lauren M. Kay, Allison L. Schmidt, Kristen L. Wilson, Heike K.Lotze, Interactive effects of increasing temperature 

and nutrient loading on the habitat-forming rockweed Ascophyllum nodosum. Aquatic Botany 133, 70-78, 2010. 4 Keats, D.W., Steele, DH and South, G.R. The role of fleshy macroalgae in the ecology of juvenile cod (Gadus 

morhua) in inshore waters off eastern Newfoundland. Journal of Zoology, 65:49-53, 1987. 5 Kelly, E (ed) The role of Kelp in marine environment. Irish Wildlife Manuals, No. 17, National Parks and Wildlife 

Service, Dept. Environment, Heritage and Local Govt., Dublin, Ireland.

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for the species. Harvesting of wild agarophytes may also reduce biodiversity on nearby beaches (TR 

2011). In 2015 there was a global downturn in availability of agar-agar.

Carrageenan production levels have decreased in Europe and increased substantially in China. Cold 

water species of red seaweed used to make carrageenan (from Chile, Mexico, Canada, and France) 

are generally harvested from wild populations. Overharvesting of Gigartina species at its 

northernmost limit in Chile resulted in a severe reduction in population size and a complete crash in 

the total number of seaweed landings in the early 2000s (TR 2011). Most carrageenan production 

comes from cultivated beds.

3. Selective harvesting: There are about 6,500 species of red algae (Rhodophyta) such as Chondrus 

species, Palmiria, Delessaria; about 2,000 species of brown algae (Phaeophyta) such as Laminaria 

species, Ascophyllum species, Sacharina, Fucus, Sargassum muticum; and about 1,500 green algae 

(Chlorophyta) such as Dunaliella, of which many are not marine. How many species of each class are 

being wild harvested? Can one species be harvested without impacting other species in the same 

location?

The TR 2016 provides Table 5, outlining algal species harvested for economic purposes. The TR 

indicates that there is limited research on this topic. Additional literature search shows some work 

has been done on multi-tropic consequences of kelp harvest on the coast of Norway, indicating 

negative impacts of kelp harvesting on fish abundance and diminishment of coastal seabird foraging 

efficiency (Lorentsen et al, 20106

). Lorentsen points out that kelp fisheries are currently managed in 

order to maximize net harvest of kelp biomass, and the underlying effects on the ecosystem are 

partly ignored. Literature review did not turn up any scientific research comparing certified organic 

kelp harvesting with non-certified wild harvesting.

There is peer reviewed research on habitat impact of seaweed on common eider ducks, such as 

Blinn et al, 2008,7 and fish impact in Nova Scotia, such as Black, 19918

, and impact of mechanical 

harvesting on Ascophyllum , such as Ang, 19939

, and Ang, 1996,10 and Arzel, 199811. And there is 

considerable research on Ascophyllum harvesting impacts.

4. Contamination: Seaweeds can sequester metal ions such as arsenic, lead, zinc and copper. What is 

the indication from the most recent scientific research on sequestration of metals by marine algae? 

Is there a difference in sequestration between species of algae? Are there additional processing steps 

taken to reduce and control for metal content from the raw seaweed material? 

6 Svein-Hakon Lorentsen, Kjersti Sjotun and David Gremillet, Multi-tropic consequences of kelp harvest, Biological 

Conservation, 143, 2054-2062, 2010. 7 Blinn, B.M., A.W. Diamond and D.J. Hamilton. Factors affecting selection of brood-rearing habitat by common 

eiders (Somateria mollissima) in the Bay of Fundy, New Brunswick, Cnada. Waterbirds 31:520-529, 2008. 8 Black, R & R.J. Miller, Use of intertidal zone by fish in Nova Scotia. Env. Bio. Fishes, 31:109-121, 1991. 9 Ang, P.O., G.J. Sharp & R.E. Semple. Change in the populations structure of Ascophyllum nodosum due to 

mechanical harvesting. Hydrobiologia, 260/261:321-326, 1993. 10 Ang, P.O, G.J. Sharp & R.E. Semple. Comparison of the structure of populations of Ascophyllum nodosu, (Fucales, 

Phaeophyta) with different harvest histories. Hydrobiologoa 326/237 179-184. 11 Arzel, P. Les luminaires sure les cotes bretonnes. Evolotion de l’exploitation et de la flottille de peche, etata 

actuel et perspectives. Editions IFREMER BP 70-29280 Plouzane, France 139 pp.

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Marine algae have a large capacity to sorb metals. In fact, algal species are often used as biosensors 

for contamination with arsenic and heavy metals. Their analysis in heavily contaminated areas, 

particularly agricultural soils, can be used to determine required bioremediation strategies (TR 2016 

775-777). The EPA found that levels were well below safe levels in research conducted in the St. 

Lawrence. However, increased pollution will lead to higher levels of arsenic and heavy metal in algae 

for human consumption.

5. Organic certified wild crafting: Which marine algal species are being harvested under the “wild 

crafting” organic standard, and in which geographic locations? 

7 CFR §205.207 provides the wild crop harvesting standard. This section is further clarified in NOP 

5022 (7/22/2011) as follows: 

4. Unmanaged, untrained and uninformed harvesting of wild products from a wild habitat 

without maintaining or improving the natural resources can disqualify the wild products 

from organic certification... and

5.4. Verification of lands or waterways: 

1. In the case of public lands or waterways, the responsible authority of those lands or 

waterways should verify that no prohibited materials have been applied to or have 

contaminated the land or waterways for at least three years prior to harvest by providing a 

signed and dated affidavit to the certified operation. 

2. In the case of private lands and waterways, the private owner shall provide a verification 

that no prohibited materials have been applied to or have contaminated the land or 

waterways for at least three years prior to harvest by providing a signed and dated affidavit 

to the certified operation.

There are 5 operations certified by the NOP to produce marine algae. One in Brazil harvests red 

algae; one in China produces nori (red algae); one in Iceland mechanically harvests both kelp 

(Laminaria digitata) and rock weed (Ascophyllum nodosum), and ecological concerns about changes 

in species diversity have been noted (TR 896-897.) In Argentina, several commercial species are 

harvested both by wild crafting and cultivation.

6. Cultivation: Which species are being cultivated, and in which geographic locations? What are the 

environmental issues associated with farming marine algae?

Increasing demand for seaweeds over the last 50 years has outstripped the ability to supply the 

market from natural wild stocks, and 90% of the market demand is met from cultivation (TR 2016, 

189-190). However, not all marine algal species are easily or economically cultivated. For example, 

Ascophyllum nodosum (Rockweed) a species widely harvested, and over harvested, for aquatic plant 

extracts and alginic acid, is a brown seaweed, which is not economic to cultivate. The TR provides 

considerable detail on seaweed farming of many species worldwide. 

7. CO2 sequestration: What does recent research indicate about the ability of marine algae to positively 

impact the environment, including global climate change, by their ability to absorb excessive CO2? 

The TR 2016 briefly presents research indicating that marine algae are critical in their role as carbon 

sinks with substantial benefits for global climates. Note also the findings of Treventhan-Tacket et al, 

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2015 which provides a comparative analysis of various seaweeds and their contribution to carbon 

sequestration12. See also Kay, 2010 cited above.

Summary: 

All materials on the National List are reviewed as separate, individual materials, described by chemical 

or species name. However each marine material grows in a complex and not fully understood ecological 

context subject to internal and external stressors, never in homeostasis. In order to fully review a 

material against the required OFPA criteria each material must be assessed in the context of where it 

grows, and with an understanding of verifiable assurances of sustainability. Production of marine 

materials must be based on the maintenance of biodiversity of natural aquatic ecosystems, and the 

continuing health of the surrounding aquatic and terrestrial ecosystems. With these contexts in mind 

the NOSB asks the public for comment on the nine marine materials noted above. 

V REQUEST FOR PUBLIC COMMENT

1. Should the naming conventions of the marine plant/algae listings on the National List be 

consolidated and/or clarified to avoid redundancies and duplication, using Latin binomials? 

2. Should annotations be written to clarify specific uses, or harvesting guidelines for any of the 

marine algae listings, such as “no machine harvesting of Ascophyllum”, and “Not harvested from 

a conservation area identified by State, Federal or International bodies”? 

3. Is there a need for further NOP Guidance on marine plants/algae?

Motion to accept the discussion document on marine algae listings on National List

Motion by: Jean Richardson

Seconded by: Ashley Swaffar

Yes: 9 No: 0 Abstain: 0 Absent: 0 Recuse: 0

12 Teventhan-Tacket S.M., Kelleway J.J., Macreadie P.I., Beardall J., Ralph P., Bellgrove A., Comaprison of marine 

macrophytes for their contribution to blue carbon sequestration. Ecology 96”3043-3057, 2015.

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National Organic Standards Board

Handling Subcommittee

Statement on proposed reclassification of xanthan gum 

September 6, 2016

The Handling Subcommittee requested an updated technical report on xanthan gum, focusing 

on the manufacturing process, to determine if it is synthetic or non-synthetic. After reviewing 

the information provided, it appears that there is more than one way to produce xanthan gum; 

some of the methods may be non-synthetic while others may lead to what the NOSB would 

classify as synthetic. Based on this determination, the Handling Subcommittee has concluded to 

take no further action on re-classification of xanthan gum at this time.

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National Organic Standards Board

Materials Subcommittee Proposal

2016 Research Priorities

August 9, 2016

INTRODUCTION

Since adopting its Research Priorities Framework in 2012, the National Organic Standards Board 

or NOSB, a Federal Advisory Committee, has presented a list of research priorities for organic 

food and agriculture. The priorities are proposed by the NOSB’s Livestock, Crops, Handling, and 

Materials/GMO Subcommittees and are published each year, prior to the fall meeting. The final 

priorities include feedback from organic stakeholders, which is publicly available through the 

Federal Register. This document reflects an effort by each Subcommittee to review and 

prioritize all previous years’ priorities from 2012-2015. The topics listed below by 

subcommittee are the 2016 priorities, including some from previous years that the NOSB thinks 

are still relevant. The older priorities and their dates of adoption can be found in a list at the 

end of this proposal. 

BACKGROUND

Research needs are prioritized along the following criteria: 1) persistent and chronic, 2) 

challenging, 3) controversial, 4) nebulous, 5) lacking in primary research, and 6) relevant to 

assessing the need for alternative cultural, biological, and mechanical methods to materials on 

the National List1. 

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: 2016 RESEARCH PRIORITIES

Although the NOSB often deliberates on the merits of a single material or process, we recognize 

that organic operations are a part of a larger whole. The entire farm as a system impacts the 

welfare of the environment and the animals that are part of that environment. Therefore, the 

NOSB urges that all research topics presented should be undertaken with consideration of the 

whole farm system. 

1 The National List of Allowed and Prohibited Substances identifies the synthetic substances 

that may be used and the nonsynthetic (natural) substances that may not be used in organic 

crop and livestock production. It also identifies a limited number of non-organic substances 

that may be used in or on processed organic products. The NOSB advises the National Organic 

Program (NOP) on which substances should be allowed or prohibited.

 

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A whole-farm, systems-based research framework will ensure that the research questions 

posed demonstrate an understanding of the interplay of the agroecology and the necessary 

biodiversity of both native and farmed species of plants and animals. This whole-farm, 

agroecological framework will ensure that confounding variables are carefully recorded as part 

of a comprehensive and practical approach to the research. Such research could contribute to 

answering some of the broader questions in organic agriculture such as:

• How can crop species and varieties be specifically adapted to site-specific conditions

through plant breeding or cultural practices? 

• How does biodiversity contribute to pest and disease resistance? 

• What is the relationship between nutrient balancing fertilization practices and microbial 

life in the soil to susceptibility or resistance to pests? 

• How can the need for a diverse agroecological system be balanced with food safety 

concerns for sustainable organic farming systems? 

• How can the complex whole environmental system inform, support, and educate a 

farmer in developing a farming system plan?

The NOSB encourages integrated research into the following areas:

Livestock

Introduction

In previous years the Livestock subcommittee has suggested basic research priorities on 

prevention and treatment of pneumonia and mastitis. The consumer expects all organic 

livestock to be treated well and be healthy. Animal welfare is of critical importance to 

producers, and consumers expect to be able to observe that their meat, wool, and eggproducing organic livestock are in good health. 

In 2015, the NOSB suggested that the research priorities on herd and flock health be changed to 

reflect a systems review of successful models of livestock production nationwide. Which 

breeds are doing best under organic management? Are we selecting the most appropriate 

breeds for high levels of herd and flock health? Which grazing management systems and 

natural resource conservation practices are producing the highest quality organic product from 

the healthiest flocks and herds? What factors appear to be contributing to healthy livestock? 

What agroecosystem and management factors contribute to the healthiest herds and flocks? 

In the context as described above, the Livestock subcommittee proposes the following research 

topics as priorities for 2016:

1. Evaluation of Methionine in the Context of a Systems 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. As the 

organic community moves toward reducing, removing, or providing additional restricting

synthetic methionine in the diets of poultry, a heightened need exists for the organic 

community to encourage omnivore producers to assist in marshaling our collective efforts 

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to find 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’s unanimous resolution to encourage the industry to move away from the use of 

synthetic methionine passed at the La Jolla, California, Spring 2015 full board meeting. A 

systems approach that includes industry and independent research by USDA/ARS, on-farms, 

and agricultural land grant universities is needed for: 

a. 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, 

b. 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 

c. 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. These types of 

research topics are complex, and it could take years to achieve the expressed NOSB resolution. 

However, an aggressive and/or heightened 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 related to bringing these 

alternative sources into commercial production is also encouraged. Furthermore, research 

should be conducted on management practices that impact a flock’s demand for methionine, 

such as flock management practices, access to pastures, 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 are raised in a manner that accommodates

the animal’s natural behavior. The organic farmer can use a limited number of approved

synthetic parasiticides in an emergency but not prophylactically. Use of synthetic 

parasiticides is limited in organic systems. 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, and herd or flock management systems have shown the 

best results with parasite control over the last 20 years? What regional differences exist in 

the U.S. in parasite prevention? Are there specific herbal, biodynamic, or other alternative 

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treatments that have been proven to work over time? What are the parasite-resistant

animal 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? 

Crops

1. Biodegradable Biobased Mulch Film (new priority in 2016) 

This type of mulch film was recently recommended by the NOSB but did not include a 

specific percentage of biobased components it must contain. In 2015, NOP issued a Policy 

Memo2 that states that certifiers and material organizations should review biodegradable 

biobased mulch film products to verify that all of the polymer feedstocks are biobased. This 

requirement makes biobased 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 NOSB 

requests answers to the following questions: 

• How rapidly do biodegradable biobased mulch films fully decompose, 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?

• Are there different cropping systems, climate, soil types, or other factors that affect 

the decomposition rate?

• What type of effect does the breakdown of these polymers have on soil and plant 

life as well as livestock that would graze either crop residues or forages grown the 

subsequent year after this mulch film was used?

• Does the use of these synthetic polymers over time affect the balance of soil 

biology?

• Is there any cumulative effect if this mulch film is used 3-5 years or more in the same 

location?

• Are the available testing regimens adequate to meet the decomposition standards in 

our definition and to validate the non-GMO status of source materials? 

2. Organic No-Till

Organic no-till practices are quite different from herbicide-based no-till systems. Organic notill, using a terminated, in-place mulching system, 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. Even though this killed-in-place mulch practice has been used for more 

than a decade, widespread adoption has not occurred. This type of production is also

attractive to conservation minded nonorganic farmers, and more practical information could 

result in the growth of domestic organic production. There are some land grant universities

and federal agencies doing research on this type of production, but more work needs to be 

2 Policy Memo 15-1

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done. 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.

• Identification of mulch crops, systems, and timing of practices that provide weed 

management benefits with minimum interference to the crop and yields?

• Research on various techniques that would provide a variety of options for diverse 

cropping systems including, but not limited to: strip tillage within a killed mulch, 

mowing or other organically approved techniques versus rolling to terminate the 

mulch, and living mulches in standing crops.

• Development of systems that allow for either continuous no-till organic crops or for 

multiple years of organic no-till in the crop rotation.

• Research on how reduced soil disturbance contributes to pest, weed, and disease 

management?

• Benefits or drawbacks of using this mulching system on weed, pest and disease 

management, as well as soil fertility, in perennial cropping systems, such as fruits. 

• Research about how the use of this system can be managed to improve water 

retention and permeation, both in annual crops and especially in perennial cropping 

systems.

• Biodiversity benefits to the living and/or killed mulches, and how they contribute to 

pest, weed, and disease management. 

• Research into what effect the system would have on nutrient balance of the soil and 

subsequent fertilization practices, including use of outside inputs. 

• Research into how this system affects soil microbial life and nutrient availability, 

given that less soil disturbance improves plant decomposition and therefore 

provides higher organic matter, and if it results in crops that are less susceptible to 

disease and pests. 

 

3. Alternatives to Antibiotics (Tetracycline and Streptomycin) for Fire Blight

Prior to October 2014, oxytetracycline and streptomycin were allowed for the control of fire 

blight in apple and pear trees only. Since 2014, neither substance may be used in any 

organic practice. Organic apple and pear growers must now find suitable alternatives to 

control the deadly fire blight disease. Since apples and pears are grown in many regions 

throughout the United States, alternatives must work in a variety of climates and 

management systems. The following research issues are important to investigate: location; 

planting density; choice of varieties of cultivar and rootstock; soil improvement practices; 

pruning practices and general sanitation; groundcovers or intercrops; pollinator 

management; dormant copper sprays; bloom thinning/lime sulfur; early, full bloom, and late 

sprays with approved organic materials to prevent fire blight establishment; surveys for fire 

blight activity; and other cultural and preventative techniques. 

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4. Alternatives to Copper for Disease and Algae Control

Organic producers have few alternatives to synthetic chemicals to control diseases. Copper 

has been used for more than a century to control serious diseases in crops such as late 

blight in tomatoes and fire blight in pears. Because the copper products degrade to 

elemental copper, continued use over time can cause copper to accumulate in soil. If used 

improperly or to excess, copper can be toxic to aquatic life and wildlife. 

Alternative materials are not yet available to address the many diseases which copper 

treats. 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. 

Some avenues for research: 

• 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 on which copper is now 

used. 

• Evaluating plant nutritional strategies to mitigate the impacts of plant diseases. 

• Determining if alternatives, such as sodium carbonate peroxyhydrate or other materials, 

are suitable alternatives to control scum and algae in rice in an aquatic environment. 

5. Plant Disease Management

There is a need for research into plant disease management practices and alternative 

materials, particularly for the humid areas of the country, that decrease reliance on copper 

or other substances that might have a negative impact on the soil and health of 

farmworkers. Pathogens include, but are not limited to: Alternaria, Erwinia, Pseudomonas, 

Xanthomonas, Cercospora, Colletotrichum, Cladosporium, powdery mildew, downy mildew, 

Phytophthora, Pythium, Mycosphaerella, Phomopsis, Taphrina, Elsinoe, Gnomonia, 

Fusicladium, Nectria, Phyllosticta, Diplocarpon, Albugo, Guignardia, Botrytis, Exobasidium, 

Entomosporium, Exobasidium, Pestalotia, Phoma, Cristulariella, and Monilinia fruticosa. 

Citrus greening, caused by the bacterium Candidatus Liberibacter, and spread by a diseaseinfected Asian citrus psyllid, is an emerging problem. Promising avenues of research include 

disease-resistant varieties, predators and parasites and how they interact with approved 

materials, nutrition (calcium, boron, and nitrogen have been identified), and botanical oils. 

In particular, both biological control of plant diseases and bio-pesticides should be a 

research priority to support organic growers. A large body of research has shown that plant 

diseases caused by bacteria and fungi can often be prevented by the application of a nonpathogenic microorganism before infection occurs. Although much basic research has been 

done to identify microbial biological control agents, there is still a need for commercial 

development, field testing, and adoption by growers. Biological controls have been 

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researched for late blight of potato and tomato (Phytophthora infestans), several diseases 

caused by Botrytis cinerea, and powdery mildew (several species) controlled by mites, fungi,

and bacteria. 

Although many biological controls and bio-pesticides have demonstrated effectiveness in 

research plots, they have often not succeeded commercially because they can’t compete 

with inexpensive synthetic chemicals used by non-organic farmers. Biological materials are 

often more expensive than conventional pesticides, and they need be applied before 

disease is apparent. In the past, there was little market for biological controls because the 

organic acreage was limited. Now that organic acreage has increased, the market for 

alternative plant disease controls has also increased which can spur commercialization of 

natural methods of disease control. The availability of biological controls for plant diseases 

can also make it more feasible for conventional farmers to transition to organic, thus 

benefitting organic consumers. 

6. Mitigation Measures for Residues in Compost

Residues of pesticides in compost material are a problem that requires research, according 

to the Organic Materials Research Institute (OMRI). Because of the importance of compost 

to organic management systems, research is needed on: types of mitigation measures that 

are efficacious; identification of problematic feedstock (e.g. cotton-based materials and yard 

waste); types of corrective action; and if thresholds for allowable residues are established, 

testing guidelines. This is more important than ever with events of 2016 regarding 

contamination in compost.

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:

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• 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. 

• Research about whether rotation of materials for cleaning and disinfecting could 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 plans to take up the issue of whether to prohibit BPA in 

packaging material used for organic foods in light of mounting evidence that it may be 

harmful. There is a need for increased research about suitable alternatives for the linings of 

cans used for various organic products such as tomatoes, beans, and soups.

4. Consumer Demand 

The NOSB often receives comments from stakeholders that consumers have expectations 

about what organic means and what inputs and ingredients should be in organic food. 

Sometimes there is a wide difference between what consumer activist groups claim and 

sales of specific categories of organic products in the marketplace. How can the NOSB 

determine whether the consumers and groups who speak up are truly representing all 

consumers of organic, and is there a better measure of consumer preference and 

expectations for organic products than sales figures? Research showing the distribution 

curve of consumer preferences and expectations around organic products would be helpful. 

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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 an NOSB Seed Purity task force.

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 thuringienses) 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 genetic presence

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. Prevention of GMO 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 questions could include: 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 role pollinators may 

have 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. 

Previous Years’ Research Priorities

For more detailed information about each topic, please see the relevant research priorities 

proposals. Each topic’s listing year is indicated. 

Whole Farm Systems (2012, 2013) 

Evaluation of Copper Sulfate for Rice (2012)

Evaluation of Genetically Modified Vaccines (GMO) (2012, 2013) 

Organic Aquaculture (2012, 2013) 

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Carageenan (2012)

Aquatic Biodiversity (2013)

Pastured Poultry and Salmonella (2013)

Commercial Availability Assessments (2013)

Herd and Flock Health (2013, 2014, 2015)

Risk Reduction from Off-Target Exposure to Non-Permitted Materials (2014)

Seed Purity from GMO (2014)

Mastitis (2014)

Pneumonia (2014)

Plant Extracts (2014)

Soil Building Practices (2014)

Subcommittee Vote: 

Motion to adopt the proposal on 2016 NOSB Research Priorities

Motion by: Emily Oakley

Seconded by: Trace Favre

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

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National Organic Standards Board 

Materials/GMO Subcommittee Proposal

Excluded Methods Terminology 

August 30, 2016

Introduction and Background

In April 2013 the project was started to grapple with the definition of "excluded methods" in the USDA 

organic regulations. This is the definition that appears in the rule (7 CFR 205.2; Terms Defined):

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. (Federal 

Register / Vol. 65, No. 246 / Thursday, December 21, 2000 / Rules and Regulations p. 80639)

The definition was based on the best efforts of the NOSB in 1995 and has provided adequate guidance to 

prohibit the use of the most obvious genetically engineered crops such as herbicide-resistant corn and 

soybeans and Bt cotton, as well as prohibit processing inputs such as genetically engineered yeasts and 

enzymes. However, this definition is in need of re-examination and updating due to rapid advances in 

recombinant DNA biotechnology since 1995 that have made for gray areas for the organic standards 

regarding interpretation and enforcement.

In 2011 and 2012 a number of confusing issues came before the NOSB and to the NOP which made it 

necessary to revisit the definition. These include genetically engineered vaccines for livestock, the use of cell 

fusion within plant families to create male sterility in brassica hybrids, whether or not GMOs could be used 

in biodegradable bioplastic mulches, and the question of whether mutated algae might therefore be 

genetically engineered. The current definition is inadequate to clarify these issues. In the last few years the 

rise of gene editing with no insertion of foreign DNA, synthetic biology, and the genetically engineered 

insects that are starting to appear make this effort even more important.

The first NOSB Discussion Document on excluded methods in 2013,1 discussed each of the terms in the 

above definition, defined and discussed other terms involved in traditional breeding, such as mutagenesis 

and conjugation, and brought up new terms that may be considered to be genetic engineering. No 

conclusions were suggested except that there is a need to do more work on the subject. The discussion

questions posed asked commenters to suggest principles on which to base GE distinctions, to offer opinions 

on what terms were and were not excluded methods, and to bring forward new terms that may need 

consideration. 

The second NOSB Discussion Document posted in September 2014 and in April 20152 analyzed the 

comments received and proposed several options for an updated definition, and principles and criteria to 

use when evaluating the various genetic modification issues. Additional terms were collected and the 

beginnings of some definitions were started. A structure was proposed similar to the one in use by the 

Research Institute of Organic Agriculture (FiBL) in Europe that involves an itemized chart with a yes/no 

column where the specific techniques could be itemized and evaluated. The Subcommittee made an 

informal recommendation, which was not voted upon, that these revisions to the definition and structure 

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for evaluating techniques be regulated through NOP guidance rather than additional rulemaking. Lastly it 

was acknowledged that there will be some unresolved issues that will need continued public discussion 

because they pose enforcement challenges, are totally hidden from view, or not enough is known about 

them yet.

Both a Proposal and a Discussion Document were posted for the April 2016 NOSB meeting. While comment 

was generally favorable to the approach taken, there clearly was the need for some refinement of the 

definitions and criteria. There was also confusion about which techniques were part of the proposal and 

which remained to be discussed further.

Goals of This Proposal/Document

The need for forward motion on this subject is more pressing every month. The fact that over 1000 pages of 

scientific references were submitted in public comment, with most of it being papers that came out since 

the NOSB GMO ad hoc Subcommittee was formed in 2012, indicates that the biotech community is rapidly 

outpacing any regulatory structure. The U.S. Department of Agriculture (USDA) has already ruled that 

certain plants produced with novel approaches to genetic manipulation will not be regulated as genetically 

modified organisms in the United States3

. It is more imperative than ever that the organic community be 

very clear about where the line is drawn regarding genetic engineering.

Public Comment from the past two and a half years has indicated strong support for this effort on the whole, 

although there is not consensus on some details. Every organic stakeholder is clear that genetic engineering 

is an imminent threat to organic integrity. Every effort must be made to protect that integrity to the extent 

that the NOSB is able to contribute to that.

The Materials Subcommittee is ready to move forward to create a structure for reviewing new technologies, 

and disseminating the results of this review in a transparent manner. To this end, the proposal portion of 

this document includes supplements to the definition in the rule based on internationally accepted language, 

criteria to use in the reviews based on that definition, and a chart of those techniques that are clearly 

"excluded methods" based on the definition and criteria.

A separate discussion document contains the technologies, terms, and issues that we have not been able to 

agree on or do not yet have enough information on or that pose challenges that we have not yet taken up. 

These items are put out for discussion to collect further public comment. They will be reviewed at future 

NOSB meetings.

Definitions 

In the previous Discussion Document we suggested a couple of possible definitions that would update the 

text in the rule to a more comprehensive one that would be flexible enough to accommodate future 

technologies and terms. We were inclined to favor the definitions in use by Codex Alimentarius that were 

also in the Cartagena Protocol. 

During the course of public comment and subsequent discussion, it has become clear that more than one 

definition is important to the organic community, but that all the terms we suggest defining here would fall 

under the Excluded Methods definition in the rule and would not change, but would strengthen that 

definition. These definitions are to be used in Guidance to supplement and update the definition in the 

regulations, while leaving the rule itself intact. It is important to adopt some definitions that are widely 

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accepted internationally and thus provide common ground with other countries who are concerned about 

GMOs in organics.

Based on public comment from the spring 2016 proposal, we decided to add a definition for 

Classical/Traditional Plant Breeding. Traditional breeding is a term used in the Excluded Methods definition 

in the rule and is therefore important to clarify what it means. However because the other definitions and 

criteria are not unique to plants, we slightly changed the wording so that they are applicable to all organisms.

In October 2015 the International Federation of Organic Agriculture Movements (IFOAM) published a 

Discussion Paper on a proposed revision to their Position on Genetic Engineering.45 Since other countries do 

not use the concept of "Excluded Methods", IFOAM proposed new definitions for three terms: Genetic 

Engineering (GE), Genetically Modified Organism (GMO), and Synthetic Biology. After examining their 

definitions, the Materials/GMO Subcommittee (MS) agrees that these three terms are important to define in 

the guidance we are proposing. However, we do not wish to take the old approach (that IFOAM is still using) 

of trying to capture all the methods and terms into one definition, because it will be out of date as soon as 

the next round of new technologies arrives. 

Therefore we are proposing that the following definitions of terms and acronyms, with sources, be adopted 

by the NOSB as Excluded Methods1

: 

Genetic engineering (GE) – A set of techniques from modern biotechnology (such as altered and/or 

recombinant DNA and RNA) by which the genetic material of plants, animals, organisms, cells and other 

biological units are altered and recombined. (First sentence modified from IFOAM Position cited above)

Genetically Modified Organism (GMO) – A plant, animal, or organism that is from genetic engineering as 

defined here. This term will also apply to products and derivatives from genetically engineered sources. 

(Modified slightly from IFOAM Position cited above)

Modern Biotechnology – (i) in vitro nucleic acid techniques, including recombinant DNA and direct injection 

of nucleic acid into cells or organelles, or (ii) fusion of cells beyond the taxonomic family, that overcomes 

natural, physiological reproductive or recombination barriers, and that are not techniques used in traditional

breeding and selection. (From Codex Alimentarius6

) 

Synthetic Biology7

 – A further development and new dimension of modern biotechnology that combines

science, technology and engineering to facilitate and accelerate the design, redesign, manufacture and/or 

modification of genetic materials, living organisms and biological systems. (Operational Definition developed 

by the Ad Hoc Technical Expert Group on Synthetic Biology of the UN Convention on Biological Diversity8

) 

Non-GMO – The term that is used to describe or label a product that was produced without any of the 

excluded methods defined in the organic regulations and corresponding NOP policy. The term "non-GMO" is 

consistent with process-based standards of the NOP where preventive practices and procedures are in place 

to prevent GMO contamination while recognizing the possibility of inadvertent presence. (Modified based 

on public comment from Spring 2016 NOSB)

1 Both definitions and criteria were worked on in between the Spring and Fall NOSB meetings by an ad hoc group with 

the following members: Julie Dawson, University of Wisconsin; David Gould, International Federation of Organic 

Agriculture Movements (IFOAM); Michael Hansen, Consumers Reports; Jaydee Hanson, Center for Food Safety; Kristina 

Hubbard, Organic Seed Alliance; Melody Meyer, United Natural Foods; James Myers, Oregon State University; Dana 

Perls, Friends of the Earth; Erica Renaud, Vitalis Organic Seeds; Dan Seitz, National Organic Standards Board (NOSB); 

Michael Sligh, Rural Advancement Fund International; Zea Sonnabend, Fruitilicious Farm and NOSB; Jim thomas, ETC 

Group; William Tracy, University of Wisconsin; Gwendolyn Wyard, Organic Trade Association.

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Classical/Traditional plant breeding – Classical (also known as traditional) plant breeding relies on 

phenotypic selection, field based testing and statistical methods for developing varieties or identifying 

superior individuals from a population, rather than on techniques of modern biotechnology. The steps to 

conduct breeding include: generation of genetic variability in plant populations for traits of interest through 

controlled crossing (or starting with genetically diverse populations), phenotypic selection among genetically 

distinct individuals for traits of interest, and stabilization of selected individuals to form a unique and 

recognizable cultivar. Classical plant breeding does not exclude the use of genetic or genomic information to 

more accurately assess phenotypes, however the emphasis must be on whole plant selection.

This series of definitions provides a better framework than the existing definition, as it elaborates the 

various technologies that would be prohibited as well as those which would be allowed. We propose to 

combine these definitions, the principles and criteria discussed below, and the terminology chart presented 

into this Proposal for Guidance on Excluded Methods.

Principles and Criteria

The NOSB has its own set of Principles of Organic Production and Handling in the Policy and Procedures 

Manual9

. The principles start with:

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.

Regarding Genetic Engineering:

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 (geo/gmos) and products produced by or through the use of 

genetic engineering are prohibited.

The following principals of Organic Agriculture are used by IFOAM10 and summarize well the guidance for 

developing a position on GMO technology.

• Principle of Health: Organic Agriculture should sustain and enhance the health of soil, plant, animal, 

human and planet as one and indivisible.

• Principle of Ecology: Organic Agriculture should be based on living ecological systems and cycles, 

work with them, emulate them and help sustain them.

• Principle of Fairness: Organic Agriculture should build on relationships that ensure fairness with 

regard to the common environment and life opportunities.

• Principle of Care: Organic Agriculture should be managed in a precautionary and responsible 

manner to protect the health and well-being of current and future generations and the environment.

Using the principles above, biotechnology processes will be reviewed to the following criteria to determine if 

they are excluded methods: 

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 invasion into the plant genome.

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2. The ability of a variety to reproduce in species-specific manner has to be maintained and genetic use 

restriction technologies are refrained from (e.g. Terminator technology).11

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.12

Most of the techniques that are considered to be genetic engineering are clearly not compatible with the 

principal of ecology because they do not work within living ecological systems or sustain them. They are also 

at odds with the Principal of Fairness because they are not available equally to all stakeholders and are often 

patented or used to create patented traits. There are significant questions around the Principle of care for 

the health and well-being of future generations and the environment. These concerns do not change just 

because a technique cannot be tested for or does not use DNA foreign to the target organism.

The secondary effects from the use of GMOs are starting to emerge clearly in parallel with the new 

technologies. Issues such as reduction in diversity on farms where GMOs are grown, the demise of beneficial 

species both above and below the soil, the decline in soil fertility and resilience from increased use of 

herbicides, the evolution of weeds resistant to those herbicides, the altered nutritional profiles of the GMO 

crop products, and the displacement of small farmers from their land are all violations of the principals of 

organic agriculture.13

Process and Product

Since the whole underpinning of the U.S. organic regulations is a process-based system, it makes sense that 

this concept carry over to defining excluded methods. This is indeed the basis of the current definition. 

However, this is not currently how U.S. government agencies regulate GMOs14, or handle other issues such 

as pesticide residues or water quality standards. 

Newer technologies, known as Targeted genetic modification (TagMo) or targeted genome editing, are 

emerging and being adopted quickly.15 These are very clearly genetic engineering techniques but are not

regulated by the current government structure because they do not involve DNA from a "pest" under the 

USDA APHIS regulatory structure. Many of these techniques involve precise changes in existing DNA without 

using foreign DNA from a different species. These new technologies make genetic modification much more 

accessible and less expensive. The resulting plants may not show up as genetically engineered in the 

commonly used testing methods because they contain no foreign DNA, just native DNA that has been 

changed at the allele level by humans. 

Forward Movement towards Structure

FiBL Research Institute for Organic Agriculture from Switzerland submitted a comment in 2013 that included 

a chart that describes methods with a yes/no column for compatibility with organic standards for both 

plants and animals16. The NOSB posed adopting such a chart on the methods that receive consensus and can 

be incorporated into guidance. It is important to identify all of these terms so that it is clear that they fall 

under the definition of excluded methods, but these terms do not need to be added to the definition itself.

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The first version of such a chart for the NOSB is presented here. Appendix A provides a brief description of 

each term with additional citations for those who want to find out more about the terms. There is so much 

terminology and so many techniques with similar or multiple names that we have added a column for 

additional names and types used for each general process. Along with lack of regulation of some of these 

processes, there is lack of standardization of the terms, so that new names and sometime proprietary ones 

are emerging all the time.

We would especially like to acknowledge the work done by the Center for Food Safety in their public 

comment for the April 2015 meeting. They have helped organize all the various terminology and provided 

substantial scientific papers that discuss all the terms.17 The technologies are grouped by the tasks that the 

methods accomplish and the types of changes made to the engineered organism. In the context of this 

proposal we are not able to discuss most of the terms at length so please see the Appendix and the CFS cited 

comment for the full reference list.

For this version of the proposal, the ones that were marked "TBD" in the previous chart below are now 

moved to the accompanying Discussion Document. The ones presented here are those that we are voting on 

as either Excluded or Allowed. A column has been added for which criteria apply to the excluded techniques 

that have led to our conclusion to exclude them.

Terminology Chart

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*

TALENs**

Oligonucleotide directed 

mutagenesis (ODM)

Rapid Trait Development 

System (RTDS) (Cibus)

YES 1, 3, 4 Most of these new 

techniques are not 

regulated by USDA and 

are hard to test for.

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

Dupont Seed Production 

Technology (SPT)

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

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Plastid 

Transformation

YES 1, 3, 4

Marker Assisted 

Selection

NO

Transduction NO

* CRISPR-Cas = Clustered regularly interspaced short palindromic repeats and associated protein genes.

** TALENs = Transcription activator-like effector nucleases.

Proposal

This proposal has three sections, to be used in NOP Guidance on Excluded Methods: 

1. Approve the definitions of Genetic Engineering (GE), Genetically Modified Organism (GMO), Modern 

Biotechnology, Synthetic Biology, Non-GMO, and Classical/Traditional Plant Breeding as written above.

2. Approve the Principles and Criteria above that will be used in the evaluation of new technologies and 

terminologies.

3. Adopt the Terminology chart proposed above and the listings in it as presented, recognizing that this will 

be added to as further deliberations occur in the future.

Subcommittee Vote

Motion to accept the three sections of this proposal as stated above.

Motion by: Zea Sonnabend

Second: Emily Oakley

Yes: 4 No: 0 Absent: 1 Abstain: 1 Recuse: 0 

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Appendix A – 

Brief Description and Additional Citations for Terms used in Excluded Methods Terminology Chart. 

Only terms that are marked YES or NO as Excluded Methods are defined here. All those marked TBD are still 

being worked on in discussion. Those marked "syn." are defined in cited reference from Center for Food 

Safety Public Comment in April 201518. Some other definitions are from the NOSB previous discussion 

document19 and from the FiBL 2015 plant breeding dossier.20

Targeted genetic modification (TaqMo) (Kuzma and Kokotovich 2011, Kokotovich and Kuzma 2014) - a 

collective term for the zinc finger nuclease techniques that create DNA double-stranded breaks at 

specific genomic locations that can then be used to alter the target gene. The genetic modification 

would not necessarily involve transfer of nucleic acids from another species, nor would it be easy to 

detect in a final product. 

• syn. Synthetic gene technologies (Then 2015) 

• syn. Genome engineering (Voytas and Gao 2014)

• syn. Gene editing (Puchta and Fauser 2013) 

• syn. Gene targeting (GT) (Puchta and Fauser 2013, Endo et al. 2015)

• syn. Sequence-specific nucleases (SSNs) (Voytas and Gao 2014): 

• syn. Meganucleases (Gao et al. 2011, as cited in FSANZ 2013) 

• syn. Site directed mutagenesis via oligonucleotides, zinc finger nuclease (ZFN) (Dow, APHIS 

2012) - an introduction of recombinant DNA through transient molecules that are identified by 

zinc-finger nucleases, with or without a repair template. The techniques resemble transgenesis 

but the end products are similar to, and indistinguishable from, conventionally bred plants.

• syn. Clustered regularly interspaced short palindromic repeats and associated protein genes 

(CRISPR-Cas system) (NYTs 3/20/2015) – a protein called Cas9 enables breaks in DNA at specific 

spots so that additional pieces of DNA and RNA can be inserted.

• syn. Transcription activator-like effector nucleases (TALENs) (Sprink et al. 2014).

• syn. Oligonucleotide directed mutagenesis (ODM) (Lusser et al. 2011)

• syn. Cibus Rapid Trait Development System (RTDS) (Beetham et al. 2012 patent) - Similar to the 

oligonucleotide targeted DNA modification it does not leave behind transgenic material, only 

uses it to create a change in a precise area of a gene.

Gene silencing via RNAi and DNA methylation - Interfering with the regulation of gene expression through 

inserting methyl groups onto RNA and DNA that then suppress the expression of the gene. Can occur 

in nature, but is used as a recombinant technique in cancer research and plant breeding.

• syn. RNA-dependent DNA methylation (RdDM) (Lusser et al. 2011)

• syn. Gene silencing via RNAi pathway (Casacuberta et al. 2015, Baier et al. 2014, Lubasik and 

Zielenkiewicz 2014, Hirschi 2012, Heinemann et al. 2013, Lundgren and Duan 2013, Wagner et al. 

2015) – A technique in which a small strand of RNA is inserted into a DNA sequence to regulate the 

expression of the gene. There is no change to the DNA sequence, but there is technical interference 

with the genome.

• RNAi-based pesticides (Palli 2014, Zhu 2013) – RNA interference (RNAi) is a technique in which gene 

silencing RNA strands are inserted into a target genome in order to regulate the expression of target 

genes. It was used to engineer rootworm resistant corn as well as to genetically engineer insects 

themselves.

Accelerated Plant Breeding Techniques

• Reverse Breeding (Dirks et al. 2009) – A process that uses several other techniques such as RNAi to 

suppress meiotic recombination, tissue culture, and then double haploidization to create parental 

lines that are homozygous to use in breeding F1 hybrids.

• Genome elimination (Comai 2014)

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• FasTrack (Waltz 2012) – a breeding scheme that has so far been used in plums where an earlyflowering gene from poplar is inserted into a plum tree. When the plum flowers in less than a year, 

it is crossed with non-transgenic varieties carrying desirable traits. Markers are used to identify the 

right traits and, at the end of the breeding program, only those are selected that do not have the 

transgene.

• Fast flowering (Flachowsky et al. 2011)

• DuPont’s Seed Production Technology (SPT) (Waltz 2012)

Synthetic Biology (see definition in main document)

• Synthetic chromosomes (Shenoy and Sarma 2010, pp. 12-13; Gaeta et al. 2012)

Embryo Transfer in animals – a technique used in animal breeding. It involves inducing superovulation of 

donor with gonadotropins, artificial insemination, recovery of embryos, isolation and storage of 

embryos, transfer of embryos back into animals, and then pregnancy.

Plastid transformation (Maliga 2004, as cited in NOSB discussion 2014) – Plastids are semi-autonomous 

organelles within higher plants with a small, highly polyploid genome. Technology has been 

developed for genetic modification of this genome independent of nuclear DNA. Currently used 

commercially in tobacco, and widely researched.

Marker Assisted Selection – Molecular markers are used as diagnostic aids to determine differences in the 

DNA sequence. They can help in selecting desired traits. The markers do not change the DNA of 

living plants and are not considered to be genetic engineering.

1 NOSB 2013. Excluded Methods Terminology Discussion Document. April 2013.

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5102656

2 National Organic Standards Board Materials/GMO Subcommittee. (2014). Discussion Document on Excluded Methods 

Terminology. August 22.

3 Waltz, E. (2012). Tiptoeing around transgenics. Nature Biotechnology, 30, 215-217. doi:10.1038/nbt.2143 4

 IFOAM – Organics International, 2015, 2015 Discussion Paper on a Proposed Revision to Position on Genetic 

Engineering and Genetically Modified Organisms in Organic Agriculture. 

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/Discussion_paper_on_GMO_position_2015.pdf 5

 IFOAM – Organics International, 2002, Postition on Genetic Engineering and Genetically Modified Organisms, P01, 

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/IFOAM_GMO_Position_Paper.pdf 6 Codex Alimentarius Commission (2003). “Principles for the Risk Analysis of Foods Derived from Modern 

Biotechnology,” CAC/GL 44>2003. Amended 2008, 2011, available at: http://www.fao.org/faoDwhoD 

codexalimentarius/shD 

proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandar 

ds%252FCAC%2BGL%2B44D2003%252FCXG_044e.pdf. 7 Two other definitions were looked at when this one was chosen: Synthetic Biology – Designing and constructing 

biological devices, biological systems, biological machines and biological organisms using a range of methods derived 

from molecular biology and biotechnology, including in virtually all cases the techniques of genetic engineering or 

genetic modification. (From IFOAM Position cited above). Synthetic biology is a maturing scientific discipline that 

combines science and engineering in order to design and build novel biological functions and systems. This includes the 

design and construction of new biological parts, devices, and systems...as well as the re-design of existing, natural 

biological systems for useful purposes.” (from SynBerc, the University of California/Department of Energy synthetic 

biology research consortium)

8 Link to the European Commission's draft definition with discussion: 

http://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consultation_21_en.ht

m

9 NOSB Policy and Procedures Manual: https://www.ams.usda.gov/sites/default/files/media/NOSBPolicyManual.pdfhttps://www.ams.usda.gov/sites/default/files/media/NOSB-PolicyManual.pdf

10 http://www.ifoam.bio/sites/default/files/poa_english_web.pdf

11 FiBL Research Institute of Organic Agriculture 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070

12 FiBL Research Institute of Organic Agriculture 2015. Dossier No. 2 Plant Breeding Techniques: an assessment for 

organic farming.

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13 IFOAM – Organics International, 2015, 2015 Discussion Paper on a Proposed Revision to Position on Genetic 

Engineering and Genetically Modified Organisms in Organic Agriculture. 

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/Discussion_paper_on_GMO_position_2015.pdf 

14 Kuzma J, Kokotovich A (2011) Renegotiating GM crop regulation. EMBO reports 12: 883–888. 15 Kokotovich A, Kuzma J (2014) Conflicting Futures: Environmental Regulation of Plant Targeted Genetic Modification. 

Bulletin of Science, Technology & Society 34: 108–120. 16 FiBL Research Institute of Organic Agriculture 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070 17 CFS Comments to the NOSB, 2015, Docket #AMS_NOP_15-0002-0874

18 CFS Comments to the NOSB, 2015. Reference List. http://www.regulations.gov/#!documentDetail;D=AMS-NOP-15-

0002-0875

19 National Organic Standards Board Materials/GMO Subcommittee. (2014). Discussion Document on Excluded 

Methods Terminology. August 22. 20 FiBL Research Institute of Organic Agriculture 2015. Dossier No. 2 Plant Breeding Techniques: an assessment for 

organic farming.

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National Organic Standards Board 

Materials/GMO Subcommittee 

Excluded Methods Terminology – Third Discussion Document 

August 30, 2016

Note: The Materials Subcommittee is posting the same discussion document from February 2016 with 

one change. Embryo transfer in animals has been added to the terminology chart with a "TBD", after 

public comment from the Spring 2016 meeting indicated that it should be considered as allowed in 

organic livestock. This and all the issues within this document will warrant further discussion at future 

meetings once the proposal for definitions and criteria is in place. If you submitted comments to the 

Spring 2016 posting, you do not need to send them again.

Introduction and Background

In April 2013 the project was started to grapple with the definition of "excluded methods" in the USDA 

organic regulations. This is the definition that appears in the rule (7 CFR 205.2; Terms Defined):

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. (Federal 

Register / Vol. 65, No. 246 / Thursday, December 21, 2000 / Rules and Regulations p. 80639)

The definition was based on the best efforts of the NOSB in 1995 and has provided adequate guidance 

to prohibit the use of the most obvious genetically engineered crops such as herbicide-resistant corn 

and soybeans and Bt cotton, as well as prohibit processing inputs such as genetically engineered yeasts 

and enzymes. However, this definition is in need of re-examination and updating due to rapid advances 

in recombinant DNA biotechnology since 1995 that have made for gray areas for the organic standards 

regarding interpretation and enforcement.

Please see the Excluded Methods Terminology Proposal from this same date for a full elaboration of the 

background and progress to this point.

This Discussion Document contains the technologies, terms, and issues that we have not been able to 

agree on or do not yet have enough information on or that pose challenges that we have not yet taken 

up. These items are put out for discussion to collect further public comment. They will be reviewed at 

future NOSB meetings.

Discussion 

There are several areas for future discussion and work on this subject:

• Additional criteria for evaluating technologies that need to be considered.

• How to detect those technologies that are excluded but may not provide detectable genetically 

engineered DNA when tested.

• Enforcement of the excluded method provisions of the rule when they are not traceable and 

undetectable.

• Additional technologies and terms that may not be clearly prohibited as excluded methods.

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• Whether the concepts adopted in the proposal should or could lead to Organic Plant Breeding 

standards and the regulation of the term "Organically Bred Variety (or Animal)"

Once the proposal section in the accompanying document is voted on the structure will be in place to 

continue looking at these issues. We are interested in input from the organic public on these issues and 

will continue to have a transparent process to keep excluded methods out of organic production.

A. Additional Criteria

In the 2015 publication on Plant Breeding from FiBLi

, the Research Institute for Organic Agriculture from 

Switzerland, there are several more criteria mentioned than we have adopted in our proposal. These 

include:

• The cell is respected as an indivisible functional entity and technical/physical invasion into an 

isolated cell on growth media is refrained from (e. g. digestion of the cell wall, destruction of the 

cell nucleus through cyto-plast fusions).

• A variety must be usable for further crop improvement and seed propagation. This means that 

the breeders’ exemption and the farmers’ right are legally granted and patenting is refrained 

from, and that the crossing ability is not restricted by technical means (e.g. by using male 

sterility without the possibility of restoration).

• The creation of genetic diversity takes place within the plant specific crossing barriers through 

fusion of egg cell and pollen. Forced hybridization of somatic cells (e.g. through cell fusions) is 

refrained from.

B. Detection and testing

Many in the organic community have proposed that there be some testing of at-risk seeds and crops for 

the presence of GMOs and a threshold beyond which the crop could not be sold as organic. Consumers 

throughout the world clearly want to know if their food has been genetically engineered. These tests are 

reliable indicators of DNA that has had foreign components introduced at the genome level.

However, in the newer gene splicing and gene editing technologies there is no foreign DNA introduced. 

The DNA in the genes has been moved around, or sequences introduced from within the same genome 

that change the expression of certain traits. Many if not most of these methods are not detectable with 

the existing tests for GMOs. While it is likely that such testing may be developed in the future, it 

becomes very challenging for the National Organic Program (NOP) and Accredited Certifying Agents 

(ACA) to determine if any new variety was produced with one of the newer excluded technologies.

Ideas for addressing this have included creating a website for plant varieties that are excluded, or some 

sort of affidavit system for ACAs to use for varieties known to be introduced from these methods. Any 

workable ideas for accomplishing a way to tell which varieties are excluded are welcome.

C. Enforcement

Hand in hand with the above detection issue is the question of how to enforce the exclusion of new 

technologies when they cannot be detected. Enforcement needs to be equal across all ACAs and there 

has to be adequate training for ACAs in how to recognize newer strains of GMOs and what to do about 

them. The same process that could be developed for detection could also tie into enforcement, but 

some creative approaches are needed for these issues since they are not being addressed by the USDA 

as a whole.

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D. Additional technologies and terms

The chart presented in the Proposal document has a number of terms that are marked "TBD" in the 

Excluded Methods column. These are the ones that need further discussion to determine which of these 

should be added to the chart and which may not be appropriately deemed an excluded method. Some 

may be excluded for some uses but not others depending on exactly how the technique is carried out.

They are repeated below, with a few notes:

Terminology Chart

Method and synonyms Types Excluded 

Methods

Notes

Protoplast Fusion TBD There are many ways to achieve 

protoplast fusion and until the 

criteria about cell wall integrity is 

discussed, these technologies 

cannot yet be evaluated.

Cisgenesis TBD A very broad term that may need 

to be divided into some allowed 

and some excluded techniques.

Intragenesis TBD Similar to cisgenesis but gene 

sequences may be re-arranged.

Transposons TBD Used in animal vaccines. May be 

excluded in some situations but not 

others.

Cell Fusion within Plant Family TBD Subject of an NOP memo in 2013, 

the issue of detection of these 

varieties needs to be addressed 

before further policies can be 

adopted.

Embryo rescue in plants TBD Many sources including FiBL think 

this is not excluded but more study 

of the methods is needed.

TILLING Eco-TILLING TBD Stands for Targeted Induced Local 

Lesions In Genomes. It is a type of 

mutagenesis combined with a new 

screening procedure.

Agro-infiltration TBD In vitro nucleic acids are introduced 

to plant leaves to be infiltrated into 

them. More study needed.

Doubled Haploid Technology TBD There are several ways to make 

double haploids and some do not 

involve genetic engineering but 

some do.

Induced Mutagenesis TBD This is a very broad term and needs 

to be divided and classified based 

on what induces the mutations, 

chemicals, radiation, or other 

stresses.

Embryo transfer in animals Embryo rescue 

in animals

TBD FiBL distinguishes embryo rescue in 

plants from animals.

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E. Organic Plant Breeding

Some groups in Europe are moving ahead with developing a full set of organic plant breeding standards. 

If this become regulation there, then a label could be given for an "Organically Bred Variety". This is far 

from being able to be achieved in the U.S.A. with a very different approach to seed regulations as a 

whole. However, it is a potential next step and may be appropriate to tie into the discussion of some of 

the remaining terms above. For more information about this see the FiBL dossier cited above.

For instance a variety created with a cell fusion event for brassica male sterility might be allowed as seed 

in organic farming (as it is now) but prohibited from being used in a variety labeled as "Organically Bred 

Variety" with an organic breeding standard.

Discussion Questions

1. Are there any additional criteria for evaluating technologies that need to be considered?

2. Do you have any insights on how to detect those technologies that are excluded but may not provide 

 detectable genetically engineered DNA?

3. Please offer any suggestions for enforcement of the excluded method provisions of the rule when 

 they are not traceable or detectable.

4. Opinions are welcome on the terms in the chart above that may or may not be clearly prohibited as 

 excluded methods.

Subcommittee Vote

Motion to adopt the third discussion document on excluded methods

Motion by: Zea Sonnabend

Seconded by: Emily Oakley

Yes: 5 No: 0 Absent: 1 Abstain: 0 Recuse: 0 

i i FiBL Research Institute of Organic Agriculture 2015. Dossier No. 2 Plant Breeding Techniques: an assessment for 

organic farming.

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National Organic Standards Board 

Materials/GMO Subcommittee Proposal 

Report to the USDA Secretary on Progress to Prevent GMO Incursion into Organic 

November 18, 2016 

The Honorable Tom Vilsack 

Secretary of Agriculture

US Department of Agriculture 

Washington, DC 20250 

Re: An update of the National Organic Standards Board’s work on eliminating the threats from 

GMO incursion into organic agriculture 

Dear Honorable Secretary Vilsack, 

As authorized in the Organic Foods Production Act (OFPA), the National Organic Standards Board 

(NOSB) provides advice to the National Organic Program (NOP) on the development of organic 

standards. (Organic Foods Production Act of 1990, 7 U.S.C. §6518 (a)) 

Five years ago, and at the request of the wider organic community, the NOSB accepted the 

responsibility for making recommendations to the NOP to address issues related to "excluded 

methods" as defined in the Federal Organic rule; specifically, to ensure that Genetically Modified 

Organisms (GMOs) are prohibited in organic production and handling. 

The issues around GMOs in organic agriculture are complex and will require long-term efforts. 

Therefore, we believe that advising you on our efforts to date is worthwhile as we move towards a 

new Administration. In the NOSB’s initial letter to you in March 2012 we stated, "We would like 

to open the door to continued dialogue with the USDA so that the responsibility to prevent GMO 

contamination of organics is shared by those who develop, use, and regulate this technology. 

USDA actions are critical to the integrity of the organic seal and consumer confidence." This report 

elaborates on the progress by the NOSB with regard to this shared responsibility. 

The Public’s Message Is Clear

The NOSB has the unique opportunity of having direct access to public comment prior to each of 

our twice-yearly board meetings, and one message has consistently, repeatedly and abundantly been 

made clear: consumers across the country have expectations there will be no GMOs in their organic 

food. The risk to the integrity of organic agriculture is significant, and seed producers, growers, 

processors and handlers are all potentially impacted by the risk of incursion of GMOs into an 

organic supply chain. 

NOSB Actions to Date 

To address public concerns, five years ago the NOSB established an ad hoc Committee on GMOs, 

which has since been incorporated into the standing NOSB’s Materials subcommittee. Since 2012 

the NOSB has undertaken the following: 

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• Developed a mission statement that states that we accept responsibility for making 

recommendations that aim to keep GMOs out of organic agricultural products, and that we 

will provide leadership in clarifying the rule regarding excluded methods. 

• In 2012, began work on the issues of keeping seed stocks free from GMO incursion. The 

work included multiple discussion documents open for public comment, an expert discussion 

panel at the Spring 2015 NOSB meeting, and an update report on the work of the 

subcommittee. Most recently, the NOSB has requested an ongoing stakeholder task force to 

continue working on details of data collection and threshold identification of needs. While 

there is still much work to be done, we can say with confidence that the organic industry has 

reached consensus on several key points: 

• Seed is an important place to start to make sure that GMOs do not enter the organic agroecosystem.

• More data is needed on the sources of how GMOs can contaminate organic systems; whether 

it enters through seed, through pollen, or through post-harvest handling activities.

• The organic industry alone should not bear the costs of genetic trespass and incursion. The 

responsibility should particularly lay with the developers of these technologies that trespass 

on the integrity of organic production. 

• In 2013 we started to examine the definition of excluded methods in the Federal Rule to see 

how it could be strengthened. The definition had been developed in 1995, and many new 

technologies and approaches have been adopted since then. After two discussion documents 

and an initial proposal, the NOSB will vote on a final document this fall. This document 

proposes guidance on additional definitions to supplement the one in the Rule, as well as 

guidance on principles and criteria for the NOSB to use when reviewing future 

biotechnologies. 

• A comprehensive recommendation was passed unanimously by the NOSB in October 2015 

on Prevention Strategies for Excluded Methods. This included best management practices 

(BMPs) to ensure the integrity of every step of organic production and handling. 

These activities have kept the topic of genetic engineering on every NOSB agenda for the last five 

years and have given organic stakeholders ample opportunity to comment on these issues. Again, 

the message has been clear: organic consumers do not want GMOs in their food, and organic 

farmers do not want GMO incursion into their fields or the toxic pesticides and herbicides that the 

use of GMOs proliferates.

USDA Leadership Is Critical

Recognition of the potential for unfair burden to be placed on non-biotech farming systems was 

clear in the mandate from your office to the USDA Advisory Committee on Biotechnology and 21st

Century Agriculture (AC21), as evidenced by their November 2012 report, “Enhancing 

Coexistence: A Report of the AC21 to the Secretary of Agriculture”. In the introduction to that 

report, AC21’s mandate was to answer the following questions:1

1. What types of compensation mechanisms, if any, would be appropriate to address economic 

losses by farmers in which the value of their crops is reduced by unintended presence of 

genetically engineered (GE) material(s)? 

2. What would be necessary to implement such mechanisms? That is, what would be the 

eligibility standard for a loss and what tools and triggers (e.g., tolerances, testing protocols, 

1 “Enhancing Coexistence: A Report of the AC21 to the Secretary of Agriculture”, November 2012, 

http://www.usda.gov/documents/ac21_report-enhancing-coexistence.pdf

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etc.) would be needed to verify and measure such losses and determine if claims are 

compensable? 

3. In addition to the above, what other actions would be appropriate to bolster or facilitate 

coexistence among different agricultural production systems in the United States? 

In one of the report’s conclusions, it states: 

“In its examination of the charge provided by the Secretary, the members of the AC21 have 

concluded that the responses to all three elements of that charge are linked. No member of the 

AC21 believes that simply putting in place a compensation mechanism to address economic 

losses to farmers arising from unintended presence of GE or other material would completely 

eliminate such unintended presence and strengthen relations between neighboring farmers.” 

As evidenced by this report, the issues of coexistence are clearly complex. The NOSB urges the 

Administration to continue to show leadership by facilitating further discussion on these issues. In 

particular, many organic stakeholders believe the USDA’s actions on genetically engineered crops 

have been insufficient to protect the organic industry. The NOSB urges you to prioritize the 

protection of the integrity of the organic industry, which as of 2015 has reached over $43.3 billion 

in annual domestic sales (Organic Trade Association survey)2

. 

Specifically, the NOSB urges you and your agency to: 

• Develop policies to address shared responsibilities for GMO contamination. 

• Strengthen farming best management practices guidance to prevent incursion of biotech 

seeds, pollen and products into conventionally and organically managed acreages. 

• Support funding for research and data collection on threshold testing of organic and nonGMO seeds.

The NOSB appreciates that a cornerstone of your administration has been the growth of Organic 

agriculture. We urge you to continue to champion organic integrity through support of concrete 

steps – including vigorous, targeted regulatory action – to ensure the concept of coexistence is 

implemented in an effective, balanced and fair manner. 

Sincerely,

NATIONAL ORGANIC STANDARDS BOARD

Tracy Favre, Chair 

Motion to accept this report to the Secretary of Agriculture on the progress to keep GMOs out of 

organic. 

Motion: Zea Sonnabend

Second: Tracy Favre

Yes: 5 No: 0 Abstain: 0 Absent: 0 Recusals: 0 

2 OTA’s 2016 Organic Industry Survey was conducted and produced on behalf of OTA by Nutrition Business Journal (NBJ). The survey was 

conducted from January 7, 2016, through March 25, 2016. More than 200 companies responded to the survey. - See more at: 

https://www.ota.com/news/press-releases/19031#sthash.nSfI5VtA.dpuf

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Sunset 2018 Review Summary 

Meeting 2 – Subcommittee Review

Crops Substances

November 2016 

As part of the National List Sunset Review process, the NOSB has evaluated the need for the continued 

allowance for or prohibition of the following substances for use in organic crop production.

Reference: 7 CFR §205.601 Synthetic substances allowed for use in organic crop production.

Copper sulfate 

Ozone gas

Peracetic acid

EPA List 3 - Inerts of Unknown Toxicity

Reference: 7 CFR §205.602 Nonsynthetic substances prohibited for use in organic crop production.

Calcium chloride 

Copper sulfate

Reference:

205.601(a)(3) Copper sulfate—for use as an algicide in aquatic rice systems, is limited to one application 

per field during any 24-month period. Application rates are limited to those which do not increase 

baseline soil test values for copper over a timeframe agreed upon by the producer and accredited 

certifying agent; and, 

205.601(e)(4) Copper sulfate—for use as tadpole shrimp control in aquatic rice production, is limited to 

one application per field during any 24-month period. Application rates are limited to levels which do 

not increase baseline soil test values for copper over a timeframe agreed upon by the producer and 

accredited certifying agent.

Technical Report: 1995 TAP (Copper Sulfate and Other Coppers); 2001 TAP; 2011 TR

Petition(s): 2001

Past NOSB Actions: 10/2001 meeting minutes and vote; 11/2007 recommendation; 04/2011

recommendation 

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/2013 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

Copper sulfate and fixed coppers used for plant disease control (§205.601(i)(2) and §205.601(i)(3)) were 

recently reviewed for Sunset 2017. . The listings currently under review, are for copper used in aquatic 

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rice production to control algae or tadpole shrimp (§205.601(a)(3) and §205.601(e)(4), respectively). 

Because copper sulfate is used in aquatic systems the current annotations include specific requirements 

for application rates. 

During the first posting, the NOSB asked for public comment on the viability of alternatives to the use of 

copper sulfate in rice, and whether ACAs had noticed an increase in baseline soil test values for copper 

in rice fields. No new information was provided about alternatives. The few ACAs who did respond did 

not report any concerns with increasing levels of copper in rice fields.

Until the 1990s the need for copper sulfate use in rice was unique to the California rice growing 

systems. Subsequently, algae, and then tadpole shrimp started to be of concern in the Missouri rice 

culture. Seeding rice into already flooded fields (water seeding) is what leads to the need for control of 

these pests. In California all rice is grown this way for a number of reasons, while in Missouri it is 

becoming increasingly popular. For this reason, rice research in other parts of the world is not relevant 

because of different growing systems, except in Australia where the rice is susceptible to snail pests. 

In the California rice system, the tail water is very carefully monitored and ponds are usually used to 

collect tail water and allow settling to occur before the water is released back into the canals. This, 

combined with the current practice of leaving rice straw in the fields from the previous crop, very much 

stops any copper from being released into the surrounding ecosystem since it binds quickly to the soil 

sediment and the rice straw.

Annual reports from the California Rice Research Board were consulted from as far back as 2006 

(http://www.carrb.com/) in preparing this review because they research all possible alternatives as they 

emerge for both the scum algae and the tadpole shrimp. They studied several microbial products, zinc 

sulfate, using barley straw, and withholding phosphorus fertilizer as techniques during that time. The 

zinc sulfate was somewhat promising but had to be used at about 5 times the rate of copper sulfate and 

the synthetic zinc may be similarly toxic as copper so no further research could be found. The microbial 

products and barley straw were not effective. Withholding phosphorus worked with synthetic chemical 

phosphorus somewhat, but not enough to pursue more research since 2010.

The reports from the CA Rice Research Board and from Cooperative Extension in Colusa County 

(http://cecolusa.ucanr.edu/newsletters/Rice_Briefs_Newsletter34775.pdf) indicate that tadpole shrimp 

are becoming an increasing problem in recent years. The hypothesis is that more operations are 

incorporating rice straw into the fields rather than removing it or burning it as was done in the past. This 

creates the conditions for tadpole shrimp eggs, which can lay dormant for up to 10 years before

hatching. . These conditions include warm temperatures in between the seeding of the rice and its 

emergence from the water (about a 6 to 12 day period). 

Since 2012, the NOSB has included in its research priorities document, a request for research into 

alternatives to copper sulfate. It will remain a priority with the hope that more promising alternatives 

may arise in the future. Public comment strongly supported the need for such research.

Motion to Remove 

The Subcommittee proposes removal of copper sulfate from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: availability of 

alternatives.

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Vote in Subcommittee

Motion by: Zea Sonnabend

Seconded by: Harriet Behar

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

Ozone gas 

Reference: 205.601(a)(5) Ozone gas—for use as an irrigation system cleaner only. 

Technical Report: 2002 TAP

Petition(s): 2001

Past NOSB Actions: 09/2002 meeting minutes and vote; 11/2007 recommendation; 12/2011 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/2013 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

Ozone is a strong oxidant and works by oxidizing plant tissue and bacterial membranes. Originally, 

ozone was petitioned for use for weed control in crop production. It was suggested that ozone be 

injected through irrigation drip tape under plastic mulch. A subsequent additional request was made for 

use of ozone as an antimicrobial agent to clean irrigation lines.

In the 2002 TAP review, one reviewer objected strongly to use of “a known and problematic air 

pollutant” in organic farming. Two reviewers felt that ozone should be permitted with restrictions.

Ozone was not approved for use in weed control, but was listed for use as an irrigation system cleaner 

in November 2003. Used as an irrigation cleaner, ozone is much less likely to be released into the 

atmosphere. Used for weed control, ozone could escape into the atmosphere. At sunset in November 

2007 ozone was recommended for relisting by a vote of 14 to 0. At sunset in December 2011 ozone was 

recommended for relisting by a vote of 13 to 0.

For the first round of public comments, the Crops Subcommittee asked for information on the scope of 

use of ozone in irrigation system cleaning. Comments from producers and organizations that work with 

organic producers indicated that there is quite a bit of use of ozone for irrigation system cleaning. One 

producer indicated that ozone is the least expensive option for irrigation cleaning. Others said they 

preferred ozone because its breakdown product is oxygen, leaving no toxic residues in the environment. 

Some organizations commented that a technical review is needed to learn if ozone could pose a hazard 

for workers or the environment, or if there are better alternatives.

The Crops Subcommittee supports relisting of ozone as an irrigation system cleaner.

Motion to Remove 

The Subcommittee proposes removal of ozone from the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: None.

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Vote in Subcommittee

Motion by: Francis Thicke

Seconded by: Harold Austin

Yes: 0 No: 4 Abstain: 1 Absent: 2 Recuse: 0

Peracetic acid 

Reference:

205.601(a)(6) Peracetic acid—for use in disinfecting equipment, seed, and asexually propagated 

planting material. Also permitted in hydrogen peroxide formulations as allowed in §205.601(a) at 

concentration of no more than 6% as indicated on the pesticide product label; and, 

205.601(i)(8) Peracetic acid - for use to control fire blight bacteria. Also permitted in hydrogen peroxide 

formulations as allowed in §205.601(i) at concentration of no more than 6% as indicated on the 

pesticide product label.

Technical Report: 2000 TAP 

Petition(s): 2008

Past NOSB Actions: 11/2007 recommendation; 11/2009 annotation change; 12/2011 sunset 

recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset Review 

10/09/2008 73 FR 59479 ; Annotation change 05/28/2013 (78 FR 31815) 

Sunset Date: 5/29/2018

Subcommittee Review

Specific Uses of the Substance: In organic crop production, peracetic acid is used to disinfect 

equipment. It can also be used as a disinfectant to treat seeds or asexually propagated planting 

material. It can be used to disinfect pruning equipment to help prevent the spread of the fire blight 

bacterium and is also used in one of the hydrogen peroxide formulations for control on the tree canopy 

of this same disease. Peracetic acid is also used in formulations of hydrogen peroxide, allowed at a 

concentration of no more that 6%, for use in organic crop production. Peracetic acid was relisted during 

the 2016 Sunset review for Handling and the 2017 Sunset listing for Livestock.

Peracetic acid is an unstable oxidizing agent, which is what makes it such an effective sanitizer. 

According to the 2016 TR, solutions of peracetic acid, hydrogen peroxide, acetic acid and water are 

produced by reacting glacial acetic acid with hydrogen peroxide, frequently in the presence of a catalyst 

such as a mineral acid (e.g., sulfuric acid). Most commercially available peracetic acid solutions contain a 

synthetic stabilizer and chelating agent such as HEDP (1-hydroxyethylidene-1, 1-diphosphonic acid) or 

dipicolinic acid (2, 6-dicarboxypyridine) to slow the rate of oxidation or decomposition.

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International uses:

• Canada – permits the use of peracetic (peroxyacetic) acid at paragraph 4.3 (Crop Production Aids and 

 Materials) with the following annotation: “Permitted for: a) controlling fire blight bacteria; and b) 

 disinfecting seed and asexually propagated planting material”. This allowance is consistent with NOP 

 regulations.

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

 acid is not listed in Annex II – Pesticides – plant protection products. Nonetheless, as of June 1, 2012, 

 the European Union and the United States have an equivalency agreement whereby organic products 

 certified to the USDA or European Union (EU) organic standards may be sold and labeled as organic in 

 both the U.S.A. and the EU.

• Codex - Not listed.

• Japan - Not listed in the Japanese Agricultural Standard for Organic Production. However, the United 

 States entered into an equivalency agreement with Japan, effective on January 1, 2104. The scope of 

 the arrangement is limited to plants and plant-based products which undergo final processing, 

 packaging, or labeling within the boundaries of those two countries.

• IFOAM - The IFOAM norms permit the use of peracetic acid for cleaning equipment and/or 

 disinfecting equipment with no final rinse (IFOAM Appendix 4, Table 2), for pest and disease control, 

 and for disinfection of livestock housing and equipment (IFOAM Appendix 5).

Technical Report: The Crops Subcommittee received a new Technical Evaluation Report on March 3, 

2016. This was not received by the Subcommittee in time to submit a proposal for the Spring 2016 

meeting. New TRs were also provided to both the Livestock and Handling Subcommittees, to provide 

consistency and also from a cost management perspective as well, even though peracetic acid is not 

currently under review in either of those subcommittees. Peracetic acid was relisted during the 2016 

Sunset review for Handling and the 2017 Sunset listing for Livestock. 

Discussion: Peracetic acid appears to be a straightforward material in that it is made from, and 

decomposes back to, acetic acid, oxygen, and water. Peracetic acid is a very strong oxidizing agent. First 

developed in 1950, it has historically been used to treat fruits and vegetables to reduce spoilage from 

bacteria and various fungi. It is used to treat bulbs, to disinfect potting soil, clean irrigation equipment, 

and in seed treatment to inactivate fungi or other plants diseases. Additionally, in organic crop 

production it is also used as a bactericide/fungicide in wash waters to help decrease Escherichia coli 

O157:H7 on some fruit and vegetable crops. With the recent removal of two antibiotics previously 

allowed for use in organic crop production to assist in fire blight reduction, use of this substance as part 

of a rotational control and fire blight prevention program has increased, according to information 

provided by some organic stakeholders during recent public comment periods.

In the December 2, 2011, NOSB recommendation for the 2013 Sunset review of peracetic acid for the 

two Crops listings at §205.601(a)(6) and §205.601(i)(8), the Board clarified the annotation change from 

the 2009 recommendation and supported it. The original recommended annotation change was:

§205.601(a)(6) Peracetic acid—for use in disinfecting equipment, seed, and asexually 

propagated planting material. Permitted in hydrogen peroxide formulations at concentration of 

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no more than 5%.

§205.601(i)(8) Peracetic acid—for use to control fire blight bacteria. Permitted in hydrogen 

peroxide formulations at concentrations of no more than 5%.

This annotation was later implemented by the NOP with a slight change. The recommended 5 percent 

limit was changed to a 6 percent limit, based on information provided during public comment stating 

the recommended 5 percent limit was too low compared to percentages in use at the time. This point of 

concern was discussed at the Spring NOSB meeting and it was decided that this slight increase in the 

percentages was necessary to adequately accommodate use rates in comments provided in public 

comments during the last sunset review cycle and no further action was needed by the NOSB on this at 

this time.

While there do appear to be other materials that could be used as a possible alternative to peracetic 

acid, this material is selected for use by many organic crop producers for many reasons: It is a strong 

oxidizing compound, works well in colder conditions, does not give off chlorine into the environment, 

used as part of a rotation process in fire blight disease control, and is the more benign of the sanitizers 

and disinfectants, since it reverts back to acetic acid, oxygen, and water in the environment. This is 

according to information provided during public comment and also contained in information found in 

the latest TR.

Concerns were raised during public comment submitted for the Spring NOSB meeting regarding the 

various forms of peracetic acid mentioned in the TR. This was discussed during the meeting and 

determined that the majority of those other sources (that were raising a concern) would not be allowed 

for use in organic crop production or other currently allowed uses, as currently shown on the National 

List. Several commenters also mentioned that they felt that all sanitizers and disinfectants should be 

looked at for a determination of need and prioritization of allowed uses. It was determined that request 

was outside of the scope of this specific Sunset Review and would need to be addressed as a separate 

issue/topic.

Other public comment mentioned that the implementation of the Food Safety Modernization Act 

(FSMA), to oversee an enhanced approach to food safety both at the farm and at the handling levels, 

places an even higher degree of necessity in having this material and/or other sanitizers available for 

use in organic crop production. 

There was overwhelming support for the continued (relisting) of peracetic acid for use in organic crop 

production. While a few commenters took a neutral position, there were no commenters either during 

the written or oral public comment periods that were specifically opposed to the relisting of peracetic 

acid.

Based on the information provided (comments, new TR, etc.), discussion during public comment periods 

(in-person, webinar, and written), and Subcommittee review and discussion: it was determined this 

material satisfies the OFPA Evaluation criteria and the Crops Subcommittee supports the relisting of 

peracetic acid.

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Motion to Remove 

The Subcommittee proposes removal of peracetic acid from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: None.

Vote in Subcommittee

Motion by: Harold V. Austin IV 

Seconded by: Emily Oakley

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

EPA List 3 - Inerts of Unknown Toxicity 

Reference: 205.601(m)(2) EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone 

dispensers.

Technical Report: N/A

Petition(s): NA

Past NOSB Actions: 10/2002 meeting minutes and vote (see pheromones); 11/2007 recommendation; 

05/2012 recommendation; 08/2015 recommendation to change annotation at 7 CFR 205.601(m)

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset Review 

10/09/2008 73 FR 59479 Sunset Review 10/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

This listing will be superseded by the annotation change approved by the NOSB for EPA List 4 and List 

inerts (§205.601(m)(1)). The NOSB is continuing the sunset review process for these EPA List 3 inerts in 

case that change cannot be implemented through rulemaking before the 11/03/2018 sunset of EPA List 

3 inerts. 

Subcommittee Review

The Crops Subcommittee supports moving the separate listing for this category into the changed 

annotation that will cover all inert ingredients, with the ones in pheromone twist ties mentioned as a 

subheading of inerts. We feel that these materials are an essential component of passive dispensers and 

have a history of use in organic farming which has reduced the use of many other pest control products. 

We have seen no new information that would cause us to question their safety to human health or the 

environment.

Additional information requested by NOSB: 

None

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Motion to Remove 

The Subcommittee proposes removal of EPA List 3 - Inerts of unknown toxicity - for use only in passive 

pheromone dispensers, from the National List based on the following criteria in the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none

Vote in Subcommittee

Motion by: Zea Sonnabend

Seconded by: Harold Austin

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

Calcium chloride 

Reference: 205.602 - Nonsynthetic substances prohibited for use in organic crop production. 

(c) Calcium chloride, brine process is natural and prohibited for use except as a foliar spray to treat a 

physiological disorder associated with calcium uptake.

Technical Report: 2007 TAP

Petition(s): 2005; 2015

Past NOSB Actions: 09/1996 minutes and vote; 11/2006 annotation change (failed); 11/2007 sunset 

recommendation; 12/2011 sunset recommendation

Recent Regulatory Background: National List amended 10/31/2003 (68 FR 61987); Sunset renewal 

notice effective 11/03/13 (78 FR 61154)

Sunset Date: 11/03/2018

Subcommittee Review

The NOSB originally voted to allow calcium chloride for use to control bitter pit in apples and as an 

emergency defoliant for cotton; the material was categorized as non-synthetic and was not included on 

§205.601 or §205.602. Calcium chloride was subsequently petitioned and added to National List 

§205.602 as a non-synthetic substance prohibited for use in organic crop production. The annotation 

states: “brine process is natural and prohibited for use except as a foliar spray to treat a physiological 

disorder associated with calcium uptake.” Calcium chloride is commonly used in organic production; 

there are currently 20 registered OMRI products and 10 WSDA registered products.

This material has historically not been allowed for direct soil applications due to high chloride and high 

solubility concerns. The Board received petitions in both 2005 and 2015 requesting removal of the 

prohibition. The 2005 petition was declined by the Board for failing all three OFPA criteria. The 2015 

petition contested these concerns and argued the contrary; however, no new substantive information 

was presented to warrant reconsideration of the petition. Because natural substitutes like limestone, 

gypsum, rock phosphate, and bone meal are unable to supply calcium in sufficient quantities when 

faced with limited calcium uptake conditions, targeted foliar sprays are appropriate.

The NOSB did not ask any questions of the public during the first posting, however, written public 

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comment supported the relisting of calcium chloride. The Subcommittee has no concerns regarding the 

continued listing of calcium chloride at §205.602.

Motion to Remove 

The Subcommittee proposes removal of calcium chloride from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: none.

Vote in Subcommittee

Motion by: Carmela Beck

Seconded by: Harold Austin

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

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National Organic Standards Board 

Crops Subcommittee 

Discussion Document on Strengthening the Organic Seed Guidance

September 6, 2016

Introduction 

For several years now the Materials/GMO subcommittee of the NOSB has been studying the issue of 

how to keep seeds used in organic systems from being contaminated with GMO content. One point that 

comes up repeatedly from the organic community is that the progress towards full adoption of 

organically grown seed in organic systems is too slow. While there is more and more organic seed 

available, there has been inconsistent progress in the proportion of organic seed in use by many growers.

It became clear that one key way to help keep GMOs out of organic systems is to strengthen the 

provisions in the rule and the NOP Guidance 5029 for the use of organic seed. The current state of the 

organic seed industry has changed since 2011 when the draft guidance was circulated, and even 2013 

when the final guidance became official. The final guidance does not reflect the progress that has been 

made in the organic seed sector since the regulations and the 2005 and 2008 NOSB recommendations 

were written.

Therefore this Discussion Document will collect public input on the areas in which the seed guidance 

could be strengthened. Along with it may be recommendations about training for Accredited Certifying 

Agents (ACAs) and enforcement. The framework for the suggestions discussed here was already solicited 

at the Spring 2016 NOSB meeting in response to the discussion document on Next Steps for Seed Purity.

Seed is much more than just an input. It is the fundamental starting point for transforming the food 

system through nutritious ecologically grown food, especially when coupled with the principles behind 

organic production of building healthy soils, using non-toxic inputs, and stewarding the soil and 

environment. As the foundation for organic farming systems, it deserves continuous attention, from 

protecting its genetic resources, to preventing contamination, to building a strong organic seed sector to 

supply the needs of a diverse and resilient agriculture.

Background

The NOSB has worked on organic seed policies since its formation in 1992. This has enabled an organic 

seed industry to rise to fill the need for high quality organic seed since the USDA organic rule was 

implemented in 2002. After the NOSB made additional recommendations on the need for guidance on 

how the organic seed requirements should be explained and enforced, the NOP published the Guidance

on Seeds, Annual Seedlings, and Planting Stock in Organic Crop Production in 2013. The guidance 

adopted many of the NOSB recommendations but not all of them, and many stakeholders felt they were 

not strong or specific enough to make sure that organic seed was the primary form used in organic 

systems. 

Since that time there has been continuing pressure from genetically engineered seeds on at-risk crops 

leading to contamination of the seed supply, and organic seed companies are struggling to stay viable 

when the adoption of organic seed is not growing at the same rate as the organic products market. 

Therefore it seems like a good time for the NOSB to re-visit the important topic of organic seed.

Relevant Areas of the Rule and Guidance

From the NOP Rule:

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§205.204 Seeds and planting stock practice standard.

(a) The producer must use organically grown seeds, annual seedlings, and planting 

stock: Except, That,

(1) Nonorganically produced, untreated seeds and planting stock may be used to produce an 

organic crop when an equivalent organically produced variety is not commercially 

available: Except, that, organically produced seed must be used for the production of edible 

sprouts;

Excerpts from the Guidance on Seeds, Annual Seedlings, and Planting Stock in Organic Crop Production 

published March 4, 2013 (NOP 5029).

4. Policy 

Producers should develop and follow procedures for procuring organic seeds, annual seedlings, 

and planting stock and maintain adequate records as evidence of these practices in their organic 

system plan (OSP). 

4.1 Sourcing of Seeds, Annual Seedlings, and Planting Stock 

4.1.3 The following considerations could be acceptable to justify use of non-organic seeds and 

planting stock as not commercially available. These considerations must be described by 

the operation in their organic system plan (OSP), pursuant to § 205.201(a)(2), and 

approved by the certifying agent. 

Form Considerations: Examples of forms may include, but are not limited to, treated or 

non-treated seeds or planting stock, use of pelleted seed..... 

Quality Considerations: Examples may include, but are not limited to, germination rate 

of the seed; presence of weed seeds in the seed mix; shelf life and stability of the seeds;

and disease and pest resistance. 

Quantity Considerations: Producers may provide evidence that quantities are not 

available in sufficiently large or small amounts given the scale of the operation. 

4.2 Recordkeeping for Organic Producers 

4.2.1 The following records should be maintained by organic producers: 

A list of all seed and planting stock, indicating any non-organic seeds or stock used, and 

the justification for their use including lack of equivalent variety, form, quality or 

quantity considerations. Records describing on-farm trials of organic seed and planting 

stock can be used to demonstrate lack of equivalent varieties for site specific conditions. 

The search and procurement methods used to source organic seed and planting stock 

varieties, including: 

1. Evidence of efforts made to source organic seed, including documentation of contact 

with three or more seed or planting stock sources to ascertain the availability of 

equivalent organic seed or planting stock. Sources should include companies that 

offer organic seeds and planting stock.....

4.4 Role of Certifying Agents 

4.4.1 Certifying agents must verify the procedures that certified operations utilize to obtain 

and plant organic varieties suitable for their operations as part of their annual review of 

the OSP. 

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...... 

4.4.3 Certifying agents shall verify the commercial availability requirements on an annual basis, 

in their review of the OSP, pursuant to§ 205.402(a)(1). 

4.4.4 Certifying agents should review an operation’s progress in obtaining organic seeds, 

planting stock and transplants by comparing current source information to previous 

years. 

Discussion

One of the main criticisms of the final guidance 5029 was that there was a failure to provide a 

framework for what continuous improvement looks like and how to achieve it in the context of seed.

Many stakeholders were concerned that the guidance was not strong enough and ignored some of the 

input that was given to the NOP in the comment period for the draft guidance. Over time we have seen 

some of the adoption of organic seed stay flat or decline.

The recently published State of Organic Seed Report1 provides some concrete statistics about the trends 

in organic seed usage over the past five years. One of the main findings is that organic farmers produce 

food in many different ways and in many different locations, soil types, and marketing strategies. 

Therefore organic seed needs to be particularly adapted to organic systems in very diverse ways. While 

organic farmers are using more organic seed than five years ago, the biggest producers are still using 

relatively little and this has an impact on overall acreage planted to organic seed. The report also points 

to inconsistency among certifiers in enforcing organic seed requirements. 

When it comes to at-risk crops from GMO contamination, the situation is more fragile and yet important 

to address. Stakeholders gave compelling input that they needed a greater use of organic seed, and 

enforcement of the organic seed provisions, if they are to stay ahead of the risks posed by GMO 

encroachment. Some of these reasons to encourage more organic seed use include: 

• Increased sales of certified organic seeds increases field sizes and reduces edge effects at the 

field-scale of organic seed production, thus minimizing GMO pollen drift. 

• Increased revenues to companies producing certified organic seeds reduces the impact of 

additional fixed costs like seed testing and potential loss of seed yields due to unexpected pollen 

flooding or higher than anticipated test results. 

• Increased demand for organic seed spurs breeding and development of biological blocking 

mechanisms to GM influx in organic varieties (e.g. Gametophytic incompatibility in corn).

• Any consideration of a testing protocol or threshhold will not work well if it only focusses on 

conventional seed used in organic systems. It appears that minimal contamination from seed 

can accumulate to significant levels in the finished crop, and therefore organic seed will need to 

reach the same standard as non-organic seed.

Key Points to strengthen the guidance: 

• Additional guidance specific to the use of “at-risk” non-organic seed. NOP’s Guidance should 

reiterate that certified operators may only use non-GMO, non-organic seed or planting stock. 

It’s suggested that language is added to 4.1 of the guidance about sourcing seeds that are 

organic and produced without excluded methods.

• Increase the number of sources required to make an exception for a non-organic untreated 

variety (especially in at-risk crops). 

• Limit the number of seasons the “3 sources” exception could be used on at-risk crops. 

1 Organic Seed Alliance, 2016. State of Organic Seed 2016. http://stateoforganicseed.org/ 

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• Establish organic seed usage as a specific Organic System Plan goal, including plans for 

transitioning to organic varieties and reviewing increases by percentage used or acreage planted.

A complete seed list of requests for exempted varieties and documented efforts to source and 

trial organic seed should be required at inspection.

• NOP should add the following language under section 4.2.1(b) of its final guidance: Records 

showing whether, from year to year, the operation has, through continuous improvement, 

increased the overall use of organic seed and planting stock. For example:

o For row crops/field crops and specialty crops grown on substantial amounts of acres, 

the percentage of total crop acreage planted with organic seed and/or planting stock 

year after year would be an appropriate measure of improvement. 

o For specialty crops grown in diverse varieties on smaller acreages, an appropriate 

measure of improvement would be the number of organic varieties of seed and/or 

planting stock used year after year, rather than the acreage.

• Track efforts and demonstrate reasonable, measurable increases in the use of organic seed over 

time. Create a framework for methodically “closing the loophole”, using the percentage of total 

varieties available in organic form as the metric & threshold. (Made-up example: 51% of 

available broccoli varieties are available in organic form, therefore all broccoli seed must be 

organic). 

• Encourage certifiers to require producers who do not demonstrate continuous improvement in 

the context of seed to do additional research in the form of consulting more than three sources 

and conducting on-farm organic variety trials, including providing the results to certifiers. 

• NOP should provide examples of noncompliances through certifier trainings so that consistent 

and uniform adherence to reinforcing the present organic seed requirements must be enacted 

by ACAs.

• Address handlers that source seed for contractual growing purposes. 

• The NOP should proactively work to encourage organic seed companies to participate in Organic 

Seed Finder and should include in the guidance an explicit reference for certifiers, inspectors, 

and producers to use this database as a seed-sourcing tool.

Discussion Questions 

1. Please provide input on the key points above.

2. Are there additional areas of the Seed Guidance in NOP 5029 that could be strengthened?

3. Are there ways to encourage increased organic seed use among larger producers?

Subcommittee Vote

Motion to adopt the Discussion Document on Strengthening the Organic Seed Guidance

Motion by: Zea Sonnabend

Second: Harriet Behar

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

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National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Aluminum Sulfate

July 19, 2016

Summary of Petition: 

Chemtrade Chemical US LLC has petitioned for the inclusion of aluminum sulfate on the National List at 

§205.601 (Synthetic substances allowed for use in organic crop production) and §205.603 (Synthetic 

substances allowed for use in organic livestock production). The petition for inclusion on §205.603 was 

addressed by the Livestock Subcommittee. This proposal will address the petition for listing aluminum 

sulfate at §205.601. A technical review of aluminum sulfate was received in May, 2015.

Aluminum sulfate, commonly referred to as alum, is used in conventional livestock production as a litter 

amendment to reduce volatilized ammonia in livestock facilities. Ammonia is naturally produced in litter 

as manure decomposes: bacteria hydrolyze uric acid to urea, and then to ammonia. Ammonia is a gas, 

which is detrimental to animal health and performance, and to the health of workers in livestock 

production facilities.

Aluminum sulfate hydrolyzes water contained in the litter, producing aluminum hydroxide (precipitate) 

and sulfuric acid. The sulfuric acid supplies acid ions (H+

) which react with ammonia (NH3) to form 

ammonium cations (NH4

+

). 

Ammonium cations combine with nitrate, sulfate and phosphate anions in the litter to form non-volatile 

salts that remain in the litter. This reduces ammonia volatilization, improving the atmosphere in 

livestock facilities, and also helps retain the nitrogen in the manure/litter, making the litter a higher 

nitrogen-containing soil amendment.

Aluminum also binds with phosphorus, producing an aluminum-phosphate complex, reducing the 

presence of soluble phosphorus. The petitioner presents this as an important feature of adding 

aluminum sulfate to livestock litter—as an environmental aid—to reduce the amount of soluble 

phosphorus in the litter in order to reduce phosphorus loss to water resources when the litter is applied 

to soils. 

Summary of Review: 

The Livestock Subcommittee, in its consideration of the petition to add aluminum sulfate at §205.603,

did not think aluminum sulfate was necessary as a litter amendment in organic livestock production 

because other nonsynthetic materials that perform the same function of reducing ammonia 

volatilization from livestock litter are currently available and in use. The Livestock Subcommittee voted 

unanimously to not add ammonium sulfate at §205.603.

The rationale presented in the petition to add aluminum sulfate to §205.601, stated that aluminum 

sulfate could be considered an environmental aid, because aluminum will adsorb and bind phosphorus, 

potentially reducing phosphorus loss to water resources when litter is applied to soils. Excess 

phosphorus in the environment is a problem today, and when too much phosphorus gets into water 

bodies it causes algal growth and eutrophication. 

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In regions with many Concentrated Animal Feeding Operations (CAFOs) manure is sometimes applied to 

fields surrounding the CAFOs frequently, and at high rates, in order to dispose of excess manure. Also, 

for high nutrient-demanding crops (like corn), when manure is applied at rates needed to supply the 

nitrogen needs of the crop, the amount of phosphorus also added in the manure is often much higher 

than crop needs, resulting in the buildup of soil phosphorus in those fields over time. 

Soluble phosphorus is naturally adsorbed and complexed with calcium, iron, aluminum and organic 

matter in soils, limiting soluble phosphorus levels and thereby reducing leaching losses to water 

resources. However, as phosphorus levels in soils increase beyond sufficiency levels for optimum crop 

yields, the solubility of phosphorus begins to increase exponentially. Under those conditions, a material 

to bind phosphorus to reduce its solubility can reduce leaching of phosphorus to water resources.

Organic crop producers are often challenged to be able to procure enough plant nutrients to meet their 

crop production needs, and are generally not motivated to build soil phosphorus up to levels that would 

result in excessive levels of soluble phosphorus. The National Organic Standards, Section 205.203(c), 

requires that “The producer must manage plant and animal materials to maintain or improve soil 

organic matter content in a manner that does not contribute to contamination of crops, soil, or water 

by plant nutrients, pathogenic organisms, heavy metal, or residues of prohibited substances.”

[Emphasis added.] Therefore, organic farmers are already required to manage their farming systems to 

prevent phosphorus contamination of water resources.

Aluminum can be phytotoxic in low pH soils. It is well documented that in low pH soils aluminum 

becomes more soluble and toxic to plants. Aluminum toxicity to plants results in reduced root systems, a 

variety of nutrient-deficiency symptoms, and reduced yields. Caution should be used in applying 

materials containing aluminum to soils with low pH. The acidic conditions of low-pH soils will solubilize 

aluminum hydroxide to Al3

+

. 

In summary, the Crops Subcommittee does not think that aluminum sulfate is needed in organic crop 

production because: 1) Nonsynthetic alternatives to aluminum sulfate are available to control ammonia 

volatilization in livestock facilities. 2) Organic crop producers normally do not apply phosphorus at levels 

beyond sufficiency levels for optimum crop production, so excessive soluble phosphorus should not be a 

problem, 3) Adding aluminum to low-pH soils could contribute to phytotoxicity.

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or Synthetic? 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. 

The manufacturing process for all the forms of aluminum sulfate included in the petition 

involves reacting liquid sulfuric acid with either bauxite ore containing aluminum hydroxide 

(Al(OH) 3) and hydrated aluminum (Al2O3∙3H2O), or synthetic hydrated aluminum previously 

refined from bauxite. Bauxite ore is the main source of aluminum for the world and contains 

various aluminum minerals and two iron minerals (Amethyst Galleries 2014). The process 

creates hydrated aluminum sulfate per the following reactions: 

From bauxite: 3 H2SO4 + 2 Al(OH)3 + 12 H2O → Al2(SO4)3 • 18 H2O 52 

From hydrated aluminum: 3 H2SO4 +Al2O3∙3H2O + 12 H2O → Al2(SO4)3 ∙ 18 H2O 53 

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The acidified formulation also contains synthetically produced sulfuric acid.

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?

The substance contains sulfur. The substance is not an inert ingredient. The substance 

aluminum sulfate is not classified by the EPA as an inert of toxicological concern (it is on EPA List 

4 (2004)). The substance is, however, approved as an adjuvant, used pre-harvest, and is 

exempted from the requirement of a tolerance (40 CFR 180.920). 

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)]

TR LINES 435-478: 

Aluminum sulfate is being petitioned as an amendment to poultry litter for consideration in 

organic livestock application. Aluminum sulfate undergoes various chemical interactions with 

the poultry litter, altering several key chemical characteristics of the litter: 

• The pH of the litter is reduced; however it is unlikely to fall below pH 7.0 in litter collected 

after the final grow out flock. Initially the treated litter pH does fall to about 5.7 and that pH 

is maintained for about 3-4 weeks (Moore et al. 2000) (Table 2). 

• Aluminum sulfate reacts with water and naturally-occurring NH3 in the litter to form NH4+, 

thus stabilizing nitrogen and reducing NH3 gas volatilization to the atmosphere. In the soil 

environment, NH4+ is transient and is either rapidly taken up by plants, microbially 

transformed to NO3- which can be taken up by plants or lost to leaching, or anaerobically 

transformed by microorganisms to N2 and N2O which are lost to the atmosphere (Halvin et 

al. 2005). 

• Poultry litter is a significant source of NH3 in the atmosphere, which causes formation of 

aerosol particles. It is also a source of nitric acid deposition to land or water bodies where it 

causes land and water acidification and nitrate pollution (NOAA 2000). Aluminum sulfate 

decreases atmospheric pollution of NH3 by reducing litter pH, which converts NH3 to watersoluble NH4+ (Shah et al. 2006). Incubation studies estimate approximately 14 g N / kg litter 

is lost from non-treated litter as NH3, while ammonia loss from litter treated with aluminum 

sulfate ranges between 0.7 to 4.07 g N / kg litter between the high and low application rates 

(Moore et al. 2000. Assuming 40,000 lbs. of litter for a 16,000 square foot poultry house 

containing 20,000 broilers (Moore and Watkins 2012), this represents a reduction of about 

400 lbs. of NH3-N lost to the atmosphere over a 42-day period with low rates of aluminum 

sulfate, and about 560 lbs. of NH3-N at high rates of aluminum sulfate. 

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• Litter treated with aluminum sulfate contains less soluble phosphate (PO43-) than nontreated litter, as Al3+ reacts with PO43- to form insoluble AlPO4 (Table 2). Although the 

total phosphorous concentration in the litter does not change greatly, phosphorous 

becomes less plant-available, and likelihood of phosphorous transport to surface water is 

reduced. Aquatic ecosystems tend to be phosphorous-limited, and phosphorous 

eutrophication of natural water bodies is reduced when land-applied litter is treated with 

aluminum sulfate. The insoluble aluminum phosphate is not available to plants as nutrients 

and instead stays in the soil as a mineral (Moore and Edwards 2005). 

• Litter treated with aluminum sulfate contains both higher total aluminum and higher soluble 

aluminum than non-treated litter (Table 2); however, runoff from fields where aluminum 

sulfate-treated litter is applied does not contain significantly higher levels of aluminum than 

fields where non-treated litter is applied (Moore et al. 1998). 

• Litter treated with aluminum sulfate contains higher total sulfur and higher soluble sulfur 

than non-treated litter (Table 2). 

• Concentration of soluble arsenic is reduced by aluminum sulfate treatment due to arsenic 

co-precipitation by aluminum (Violante et al. 2006) (Table 2). 

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)]

TR LINES 356-387:

Toxicity: Aluminum sulfate is considered a dry acid, and is an irritant to the skin and eyes (UNLIO 2012). However, acidity created by the substance is neutralized by the litter, and litter 

applied to land generally has a near-neutral pH (Sims and Luka-McCafferty 2002). 

Mode of action: Aluminum sulfate reacts with water to create acid, which reduces ammonia 

losses from litter in confined poultry operations. Furthermore, aluminum causes precipitation of 

phosphates, reducing phosphorus solubility in the land-applied litter (Moore and Watkins 2012). 

Breakdown products: Breakdown products of aluminum sulfate include Al3+, Al(OH)2+, 

Al(OH)2+, Al(OH)3, SO42-, HSO4-, and H2SO4, and H3O+ (McBride 1996). Aluminum phosphate 

(Al(PO4)) precipitate is also formed via reaction of Al3+ with phosphates in the litter (Warren et 

al. 2008). 

Toxicity of breakdown products: Free Al3+ is a toxic species that increases in concentration as 

pH decreases, and typically reaches phytotoxic levels when pH falls below 5.0 (Havlin et al. 2005). 

Poultry litter without aluminum sulfate typically ranges in pH from 8.0 to 8.9 (Sims and LukaMcCafferty 2002). Shortly after aluminum sulfate application, pH of the litter decreases to about 

5.7, but becomes neutralized (near pH 7.0) after 3-4 weeks due to reaction with NH3 in the 

poultry guano (Moore et al. 2000). Thus, although adding aluminum sulfate increases total 

concentration of aluminum, persistence of the toxic Al3+ species is not enhanced. In contrast, 

application of litter near pH 7.0 to acidic soils decreases solubility of toxic Al3+ (Moore and 

Edwards 2005). 

 

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Persistence of the breakdown products: Aluminum hydroxide and phosphates from aluminum 

sulfate addition to poultry litter are persistent in the soil after land application due to low 

solubility (Warren et al. 2008). Sulfates, however, are more soluble, serve as a source of sulfur 

for crop plants, or are lost to leaching (Havlin et al. 2005). 

Contaminants: The primary contaminants present in the Al2O3 precursor to aluminum sulfate 

include SiO2, Fe2O3, and Na2O, and could carry though into the final aluminum sulfate product, 

however do not pose toxicological concerns (Carter and Norton 2007) 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

TR LINES 392-429: 

Aluminum sulfate is a dry acid, and can create zones of high acidity if accidentally spilled. Acid 

damage severity from a concentrated spill is dependent on the quantity spilled, and also on the 

moisture available for reacting. If the spilled material does not come into contact with moisture, 

the majority of the material could be cleaned up before significant acidification occurs. . But, 

surfaces of most soils are typically fissured and loose, and sometimes moist, making complete 

soil cleanup unlikely. Aluminum sulfate is designated as a hazardous substance under the 

CERCLA (superfund), and discharges exceeding 5,000 lbs (2,270 kg) require notification to the 

U.S. Environmental Protection Agency (TABLE 302.4 40 CFR). 

Localized environmental acidification has a profound impact on chemical equilibrium regulating 

biological systems. In the soil, acidic conditions cause enhanced solubility of the Al3+ species, 

which is toxic to plant roots. Furthermore, both H+ and Al3+ are more strongly adsorbed to soil 

cation exchange sites than calcium, magnesium, and potassium and cause potential soil 

depletion of these nutrients via leaching. Soil remediation of large aluminum sulfate spills can be 

accomplished with a liming agent to neutralize the acidity and reduce solubility of Al3+ (NIH 

2014). 

Aluminum sulfate is sometimes deliberately added to water bodies impaired by phosphorus 

eutrophication, but accidental discharge of large quantities could cause excessive water 

acidification and subsequent solubilization of Al3+ which is toxic to aquatic organisms (UN-ILO 

2012). 

Personal protective equipment should be used when applying aluminum sulfate in the poultry 

house, but no specific precautions are needed for handling spent litter treated with aluminum 

sulfate due to the high level of dilution in the litter. In the poultry house, any aluminum sulfate 

spills should be incorporated into the litter to prevent ingestion by the birds (Walker and Burns 

2000). Applications of liquid ammonium sulfate are typically made by certified applicators due 

to transport restrictions (Moore and Watkins 2012). 

Aluminum sulfate reduces environmental contamination of phosphorus in natural water bodies 

from surface litter applications, compared to non-treated litter. Moore and Edwards (2005) 

measured 340% greater cumulative phosphorus load in runoff water from non-treated litter 

than from treated litter in a paired watershed study. 

The process of extracting bauxite ore has a deleterious impact on the environment through 

habitat degradation and fragmentation by roads, and through carbon emissions (Cooke 1999). 

After extraction, regulations in some countries require replacement of topsoil and other 

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remediation measures; however quality of land after remediation is unlikely to be equivalent to 

before-extraction parameters (Cooke 1999). Most of the bauxite extraction worldwide is for the 

production of aluminum oxide, and less than 5% of bauxite imported into the U.S. is used for 

other purposes including aluminum sulfate production (USGS 2014) 

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)].

TR LINES 544-563: 

Aluminum sulfate reacts with water to form sulfuric acid, which is an irritant. Aluminum sulfate 

is corrosive to the eyes; skin contact causes a rash and burning feeling, and inhalation causes 

throat and lung irritation (New Jersey Department of Health 2009). The magnitude of the toxic 

response to aluminum sulfate is completely dose-dependent, and the substance is permitted as 

a food additive in small quantities. Minor ingestion of dilute solutions causes stomach upset, 

while substantial ingestion can rarely cause hemorrhagic gastritis, circulatory collapse and multiorgan failure (United Kingdom National Poisons Information Service 1996). 

Aluminum is a subject of medical contention with suspected links to Alzheimer’s disease. 

Implications of a link between Alzheimer’s disease and aluminum have been made for 

approximately 40 years. The current large body of research has not concluded specific roles of 

aluminum in contributing to Alzheimer’s disease, but also has not dismissed aluminum as a noncontributor to the disease (Agency for Toxic Substances and Disease Registry 2008; Exeley 2001). 

Under FDA regulations, aluminum sulfate is generally recognized as safe (GRAS) as a food 

additive when used in accordance with good manufacturing or feeding practice (CFR 

182.1125(b)). 

Although aluminum sulfate has chronic toxicity for human exposure, use of the substance as 

petitioned should not have negative effects on human health. Use of the substance as 

petitioned decreases ammonia concentration in the atmosphere of poultry houses, which has a 

positive impact on both health of the birds and health of workers (Moore et al., 2000).

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)] 

 

TR LINES 485-522: 

Aluminum sulfate is not applied while birds are in the poultry house. The substance is not 

applied before the first flock grow-out; however, it is systematically applied thereafter before 

every flock is exposed to the litter. Any spills or concentrations of the product should be 

dispersed into the litter to avoid consumption by young chicks (Walker and Burns 2000). As 

stated in the petition, aluminum sulfate is not applied to feed. In the event of accidental 

ingestion, aluminum sulfate is corrosive and irrigating to the digestive system and kidneys of 

birds (Dumonceaux and Harrison 2013). In one study, Japanese quail fed aluminum sulfate as 

>0.10% of their diet reduced body weight accumulation, eggshell strength, plasma inorganic 

phosphorous, feed consumption, and egg production (Hussein et al. 1988). Physiological effects 

of aluminum sulfate intake by broiler chickens occurs at higher intake levels than quail, with 

decreases in weight gain when consumed at >0.93% of the diet. Higher concentrations of 

aluminum sulfate in the diet cause more severe depressions in weight gain, decreased bone 

strength, and serum phosphorous. At application rates of 100 g / kg litter, birds would need to 

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ingest 10% of total dietary intake as litter to exceed 0.93% aluminum sulfate in the diet, and the 

aluminum would need to be in the original non-reacted aluminum sulfate crystalline form which 

does not persist in the presence of moisture. Typical observed litter ingestion rates are below 

this threshold, ranging from 2% to 5% of daily dietary intake. Aluminum sulfate is toxic to 

poultry if directly ingested in large quantities, but not at levels expected from litter consumption 

(Huff et al. 1996). When aluminum sulfate is used, mortality decreases and poultry weight gain 

increases, indicating the birds are likely not suffering toxic effects from incidental aluminum 

sulfate ingestion from the litter (Walker and Burns 2000). 

Deleterious effects of aluminum sulfate on the head, skin, feathers, or feet of poultry were not 

revealed in the literature review, but the material is an irritant (UN-LIO 2012). If aluminum 

sulfate remains in its original non-reacted dry form, there is potential for foot irritation. 

Producers can mitigate the potential of bird exposure by rototilling aluminum sulfate into the 

litter after application, and before birds are placed back in the poultry house. Liquid 

formulations are less likely to expose birds to concentrations of the chemical due to greater 

dispersal in the litter compared to dry formulations (Moore and Watkins 2012). Aluminum 

sulfate tends to dry out the litter, and in turkeys the use of aluminum sulfate decreased the 

incidence of foot pad dermatitis, which is associated with wet litter (Wu and Hocking 2011). 

In addition to the phosphorous-fixing properties of aluminum sulfate, litter treated with 

aluminum sulfate inhibits microbial phosphorous mineralization from organic matter (Warren et 

al. 2008). Although the literature review did not reveal problems associated with salinity of litter 

treated with aluminum sulfate, treated litter contains higher levels of soluble NH4+, and sulfur; 

thus, the salinity is likely higher than non-treated litter. However, salt damage to crops at 

normal agronomic application rates is likely low due to dilution factors (Sims and LukaMcCafferty 2002). Effects on bird health are positive, as ammonia accumulation causes lung 

irrigation to poultry (Walker and Burns 2000). Pathogen loads in the broiler house are reduced 

with aluminum sulfate, which combined with lower ammonia concentration in the air causes 

increased bird weight gain (Shah et al. 2006).

6. Are there any adverse impacts on biodiversity? (§205.200) 

Aluminum sulfate reacts with water and naturally-occurring NH3 in the litter to form NH4+, thus 

stabilizing nitrogen and reducing NH3 gas volatilization to the atmosphere. In the soil 

environment, NH4+ is transient and is either rapidly taken up by plants, microbially transformed 

to NO32- which can be taken up by plants or lost to leaching, or anaerobically transformed by 

microorganisms to N2 and N2O which are lost to the atmosphere (Halvin et al. 2005). Although 

nitrogen is more persistent in the litter, there is no effect on cumulative soil nitrogen 

accumulation compared to non-treated litter, as aluminum sulfate does not alter the organic 

fraction of the total nitrogen. (TR 443-449)

Litter treated with aluminum sulfate contains less soluble phosphate (PO43-) than non-treated 

litter, as Al3+ reacts with PO43- to form insoluble AlPO4 (Table 2). Although the total 

phosphorous concentration in the litter does not change greatly, phosphorous becomes less 

plant-available, and likelihood of phosphorous transport to surface water is reduced. Aquatic 

ecosystems tend to be phosphorous-limited, and phosphorous eutrophication of natural water 

bodies is reduced when land-applied litter is treated with aluminum sulfate. The insoluble 

aluminum phosphate is not available to plants as nutrients and instead stays in the soil as a 

mineral (Moore and Edwards 2005). (TR 462-468)

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Litter treated with aluminum sulfate contains both higher total aluminum and higher soluble 

aluminum than non-treated litter (Table 2); however, runoff from fields where aluminum 

sulfate-treated litter is applied does not contain significantly higher levels of aluminum than 

fields where non-treated litter is applied (Moore et al. 1998). (TR 469-472)

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)]

Alternatives to litter amendments include management practices such as proper air exchange in 

barns, removing caked areas and keeping litter areas dry.

TR LINES 569-581: 

Clinoptilolite is a naturally-occurring aluminosilicate zeolite which can absorb ammonia, 

reducing volatilization to the atmosphere. The literature contains results of mixed efficacy for 

this material, with some reports of decreased ammonia in broiler house air, and other reports of 

increased atmospheric ammonia (Amon et al. 1997; Karamanlis et al. 2008; Shah 2006). 

 Agricultural lime can be applied to litter between flocks to increase litter pH, 

chemically inducing volatilization of large quantities of ammonia. The volatized 

ammonia can then be removed by ventilation before birds are placed back in the 

poultry house. Removal of ammonia from litter in between flocks reduces ammonia 

concentration in air for the subsequent grow-out, but does not mitigate ammonia 

production during the grow-out compared to acidification products. Although lime 

does not decrease total atmospheric ammonia pollution like aluminum sulfate, 

phosphorous in the litter is stabilized by complexation with calcium at high pH to 

reduce eutrophication of natural water bodies after land application of the litter 

(Shah 2006).

During the Spring 2016 in-person public comment session at the National Organic Standards 

Board meeting in Washington, DC the board did receive one public comment that stated there 

are OMRI listed poultry litter amendments currently in use and was provided information from a 

currently listed OMRI poultry litter amendment product on concerns they had with the TR on all 

litter amendments being brought forward in 2016. The commenter felt that the board should 

not approve additional poultry litter amendments when there are already OMRI-certified 

products being used in the marketplace.

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

No. This substance requires the use of sulfuric acid in its manufacture. Also, the proposed use of 

this substance to reduce soluble phosphorus in organic cropping systems assumes the presence 

of excessive phosphorus levels in soils on organic farms, which is not in keeping with the 

National Organic Standards or with a system of sustainable agriculture. Further, use of this 

substance in soils with low pH could result in aluminum toxicity to plants. Also, nonsynthetic 

alternatives exist to control ammonia volatilization in livestock facilities.

114/279
Classification Motion: 

 

Motion to classify aluminum sulfate as synthetic 

Motion by: Francis Thicke

Seconded by: Harriet Behar

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

National List Motion: 

Motion to add aluminum sulfate at §205.601 

Motion by: Francis Thicke

Seconded by: Harriet Behar

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

115/279
116/279
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal 

Soywax

July 5, 2016

Summary of Petition: 

Soy wax has been petitioned as a synthetic substance for use in organic mushroom production to seal 

plugs and ends of logs inoculated with mushroom spawn. Soy wax is intended to be used for the same 

purpose as microcrystalline cheesewax, which is currently listed at §205.601(o) as a production aid in 

the production of saprophytic mushrooms grown on logs.

Summary of Review: 

Soy wax is produced from oil extracted from soybeans. The oil is hydrogenated, making it a solid at room 

temperature. Crystalline cheesewax, which is currently listed for the use, is made from petroleum. Soy 

wax, which is now available from non-GMO, domestically-produced soybeans, was petitioned for use 

because it has fewer environmental and health impacts than products made from petroleum.

Sox wax is considered synthetic because when it is hydrogenated, it undergoes a chemical change that 

does not happen naturally. Hydrogenation is the process whereby the poly- and mono-unsaturated oils 

are turned into saturated oils, solidifying them in order to increase the viscosity. As the petition 

describes it, this process involves the reaction of hydrogen with soybean oil at elevated temperature 

(140-225o

C) in the presence of a nickel catalyst. Therefore, even if soy wax were made from organic 

soybeans by this process, it would be synthetic.

A proposal to add soy wax to §205.601 was considered at the April 2016 meeting in Washington, D.C., 

but was referred back to the Crops Subcommittee for further discussion.

The Crops Subcommittee supports the addition of soy wax made from non-GMO soybeans to the 

National List as an alternative to microcrystalline cheesewax, which is made from petroleum.

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or Synthetic? 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. 

Yes, the soybean oil is hydrogenated, a process in which double bonds between carbon and 

hydrogen atoms in the oil are converted into single bonds to make saturated fats. This is a 

chemical (synthetic) process that is accomplished by the reaction of hydrogen with the oil at 

elevated temperature (140-225o C) in the presence of a nickel catalyst. 

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 

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production and contains synthetic inert ingredients that are not classified by the Administrator 

of the Environmental Protection Agency as inerts of toxicological concern?

Yes, soy wax is used as a production aid

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)]

Vegetable oils are not very reactive chemically and they biodegrade readily in the soil.

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)]

There should not be any because vegetable oils are not toxic and fully biodegrade in the soil.

The breakdown products are carbon dioxide and water.

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

The process of hydrogenation involves dissolving hydrogen in soybean oil in the presence of 

heat and a nickel catalyst. No other chemical inputs are required or need to be disposed of.

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)]. 

Hydrogenated soy oil is considered a trans-fatty acid, which has been shown to increase the risk 

of heart disease, so nutritionists recommend avoiding it in human diets. However, little--if any--

soy wax is expected to be consumed in edible mushrooms that have been grown on logs treated 

with soy wax.

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)] 

Soy wax is hydrogenated soybean oil and is non-toxic and biodegradable in soil. Soybean oil is 

commonly used in livestock feeds.

6. Are there any adverse impacts on biodiversity? (§205.200) 

There should not be any adverse impacts on biodiversity because soybean oil is nontoxic and 

readily degraded by soil organisms. 

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)]

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The currently used alternative is microcrystalline cheesewax, a synthetic made from petroleum, 

which is on the National List. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

Yes, it is more compatible than the petroleum-based material currently being used for 

mushroom production.

Classification Motion: 

 

Motion to classify soy wax as synthetic

Motion by: Francis Thicke

Seconded by: Harold Austin

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

National List Motion: 

Motion to add soy wax at §205.601 of the National List (o) As production aids. Soy wax (CAS # 8016-

70-4)--for use in log grown mushroom production. Must be made from soybeans grown without 

excluded methods if soy wax from organic soybeans is not commercially available.

Motion by: Francis Thicke

Seconded by: Emily Oakley

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

119/279
120/279
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

1-Methylcyclopropene (1-MCP)

July 5, 2016

Summary of Petition 

The NOSB Crops Subcommittee received a proposal for 1-Methylcyclopropene (1-MCP) to add to the 

National List at §205.601. The proposed use is as a post-harvest treatment for apples to delay fruit 

ageing and slow down ripening so that the apples can be stored for a longer period. It was noted that 

the condition of the fruit was improved after it is removed from storage until it reaches consumers. The 

product, as petitioned, is used in sealed storage rooms. A technical report was not requested for this 

material because there was sufficient information in the petition for the review.

1-Methylcyclopropene (1-MCP) binds to ethylene receptor sites and slows ethylene activity, thus 

slowing ripening. 1-MCP is a hydrocarbon gas with a similar structure to ethylene although it does not 

occur in nature. The ethylene receptor sites have a higher affinity for 1-MCP than ethylene. The generic 

material is always formulated with a natural sugar (alpha cyclodextrin) to stabilize the gas.

Summary of Review: 

The Subcommittee notes that while the manufacturing process of this substance is proprietary, enough 

information was provided in the petition, including a link to the patent, that the NOSB can clearly 

determine that it is a synthetic material that does not occur in nature.

The Subcommittee discussion revolved around the points listed in the Category 3 compatibility section 

below. First, it is a synthetic substance that does not fit in the categories for exemptions given in OFPA 

[§6517(c)(1)(B)(i)]. Second, extending the storage life of a crop is not one of the criteria in OFPA 

[§6518(m)] that is used to evaluate materials. Lastly, there are alternative practices that can help with 

storage. The NOSB does not support the addition of synthetic materials to the National List in an effort 

to make a seasonal crop available year round. 

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or Synthetic? 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. 

2. Reference to appropriate OFPA category: NONE

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?

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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)]

The substance is not used in the environment but in a closed room, so no potential to interact.

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)]

1-MCP competes with ethylene for the ethylene receptor sites and due to its higher affinity 

selectively binds to the sites. According to the petition, 1-MCP is non-toxic and non-persistent, 

and this is cited by a reference to TOXNET. It is a gas in the atmosphere and has a half-life of 4.4 

hours.

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

A closed system is used for manufacture and the manufacturing facility meets all industry safety 

standards for environmental controls, recycling waste, and employee exposure.

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)]. 

1-MCP has been used for more than 15 years. There are no residues in the fruit when it reaches 

the consumer.

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)] 

Not used in soil or environment.

6. Are there any adverse impacts on biodiversity? (§205.200) 

No. Not used in environment.

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 alternatives in the broad sense, although there are no other non-synthetic or allowed 

synthetic materials with a similar function. A key point in the petition is that no other practices 

or materials work as well once the fruit has left the storage room until it is sold. For this issue 

there is not alternative other than rapidly getting the fruit to market.

 Alternatives noted by the Crops subcommittee include: 

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• Crop nutritional approaches to enable apples to store longer, such as increased calcium in 

the fruit.

• Excellent harvest and post-harvest handling practices such as picking at the right time for 

storage, timely handling to get fruit into storage, and optimal storage conditions.

• Use of varieties that store better than others, such as Goldrush, Enterprise, Granny Smith, 

and numerous heirloom apples. 

• For consumers, choosing fresh organic apples from the southern hemisphere in the apple 

off season.

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

The substance is not compatible for a number of reasons. First, it is a synthetic substance that 

does not fit in the categories for exemptions given in OFPA [§6517(c)(1)(B)(i)]. Second, 

extending the storage life of a crop is not one of the criteria in OFPA [§6518(m)] that the NOSB 

must use to evaluate materials. Furthermore, there are alternative practices that can help 

apples store longer and the NOSB has been of the opinion that having a seasonal crops available 

year round is not a sufficient reason to add a synthetic material to the National List.

Classification Motion: 

 

Motion to classify 1-Methylcyclopropene (1-MCP) as synthetic 

Motion by: Zea Sonnabend

Seconded by: Emily Oakley

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

National List Motion: 

Motion to add 1-Methylcyclopropene (1-MCP) at 205.601 

Motion by: Zea Sonnabend

Seconded by: Harold Austin

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

123/279
124/279
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Ammonium Citrate

September 6, 2016

Summary of Petition: 

Alpha Chelates has petitioned for the inclusion of Ammonium citrate on the National List at §205.601 

(synthetic substances allowed for use in organic crop production). Ammonium citrate is used as a 

chelating agent. Ammonium glycinate was petitioned at the same time for an equivalent use and will be 

addressed in a separate proposal. 

Ammonium citrate, or citrate ammonium salt, is an amino acid. As an organic chemistry salt, it is 

reacted with trace metal salts of copper, iron, manganese, or zinc to form a chelate. The petitioner 

manufactures liquid micronutrient chelates using ammonium citrate as the chelating agent. Chelates 

are used to provide micronutrients that are readily available to plants in deficient soils. 

Ammonium citrate is manufactured though a reaction of ammonium hydroxide and citric acid. The 

petition argues that approval of ammonium hydroxide is understood in the listing of ammonium 

carbonate in §205.601(e)(1) since it is a salt of ammonium hydroxide and carbonic acid (ammonium 

carbonate is listed for use “in insect traps only, no direct contact with crop or soil”). Further, the 

petitioner claims that since lignin sulfonate is listed as a chelating agent in §205.601(j)(4) and because 

OMRI approves the use of ammonium lignosulfonate, ammonium citrate should be allowed.

The petition states that chelated trace minerals are necessary in high pH soils because the simple metal 

micronutrient salts allowed in §205.601(j)(6)(ii) otherwise need to be applied at four to five times the 

rate of plant up-take because unchelated micronutrients precipitate quickly when they come into 

contact with soils high in pH. Additionally, the petitioner claims that although nonsynthetic chelating 

agents can be produced, they are incompatible with the manufacturing of chelates as a result of 

unpredictable variations in species and composition.

In addition to the information on ammonium citrate, the petition puts forth a case that the use of the 

term “chelating agent” in the regulations needs to be revisited. The petitioner contends that both the 

cation and anion of a salt approved for use as a chelating agent should be on National List. The 

petitioner requests that the NOP define which bases can be used to neutralize acids used to synthesize

chelating agents. However, these claims and request are beyond the purview of this Subcommittee

whose role in this case is the review of substances petitioned for inclusion on the National List. 

Summary of Review: 

Upon review of the petition, the Subcommittee determined that there was insufficient information in 

the justification statement regarding the necessity of the material for organic crop production. The 

Subcommittee sent a request to the petitioner, asking why the petitioned materials would be better 

than the nonsynthetic and/or synthetic chelating agents that are already allowed. The petitioner 

submitted an addendum but still did not completely address the question of alternatives. The 

addendum claims that there are no nonsynthetic substances, nor any substances already on the 

National List, that could be used in place of ammonium citrate. The petitioner subsequently 

volunteered a second addendum. 

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Despite the submission of the second addendum, the petitioner did not make a convincing case that the 

permitted products already on the market are inadequate to meet farmers’ needs. The petitioner does 

not provide evidence that chelates made with synthetic citrate are needed to replace lignin sulfonate 

and nonsynthetic chelating agents such as fulvic acids, humic acids, and nonsynthetic citrate currently in 

use by organic growers.

The Subcommittee did not request a technical review after determining that the petitioned material was 

not necessary for organic production. 

The Subcommittee has concluded that the petitioned substance does not meet the OFPA criteria and 

therefore should not be added to the National List.

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or synthetic? 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. 

No

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)]

Chelates occur in nature and are used at low rates in organic farming, so there should be no 

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)]

Ammonium hydroxide and citric acid are introduced in a reaction vessel to produce ammonium 

citrate, a salt. The amino acid citric acid is neutralized by the alkali ammonium hydroxide. 

Ammonium citrate is reacted in a solution with copper, iron, manganese, or zinc salt to form a 

126/279
liquid chelate of the given metal. Chelates are applied in low dosages; application rates for the 

chelates manufactured by the petitioner are 1.2-2.5 kg/ha. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

The petition states that there is minimal chance of environmental or human contamination 

during the manufacturing process as the reaction takes place inside a sealed vessel. As stated 

above, the petitioned substance is an ingredient in a finished product and is converted into a 

metal salt chelate and is therefore not subject to questions of disposal. However, ammonium 

hydroxide is used in the manufacture of the substance, and ammonium hydroxide is produced 

by the reaction of ammonia with water. Ammonia can be harmful to human health and aquatic 

life if spilled or improperly handled.

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)]. 

The petition states that “in the unlikely event of contact of reaction vessel contents with human 

skin, there is a very low level of hazard as the substance is at a low concentration, is not toxic, 

and can be easily washed off with water”.

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 Subcommittee is not aware of negative effects of the petitioned material on biological and 

chemical interactions in the agroecosystem.

6. Are there any adverse impacts on biodiversity? (§205.200) 

None known.

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)]

Alternatives to the petitioned substance exist and are currently in use, including lignin sulfonate, 

humic acids, fulvic acids, and nonsynthetic citrate. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

Chelates occur naturally in soils, so chelates, per se, are not incompatible with a system of 

sustainable agriculture. However, overreliance on synthetic materials is not compatible with a 

system of sustainable agriculture. The subcommittee has determined that there are insufficient 

grounds for adding this substance to the National List as there are natural alternatives and one 

allowed synthetic already available. 

127/279
Classification Motion: 

 

Motion to classify Ammonium Citrate as synthetic

Motion by: Emily Oakley

Seconded by: Francis Thicke

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

National List Motion: 

Motion to add Ammonium Citrate as petitioned at §205.601

Motion by: Emily Oakley

Seconded by: Francis Thicke

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

128/279
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Ammonium Glycinate

September 6, 2016

Summary of the Petition:

Alpha Chelates has petitioned for the inclusion of Ammonium glycinate on the National List at §205.601 

(synthetic substances allowed for use in organic crop production). Ammonium glycinate is used as a 

chelating agent. Ammonium citrate was petitioned at the same time for an equivalent use and will be 

addressed in a separate proposal. 

Ammonium glycinate, or glycine ammonium salt, is an amino acid. As an organic chemistry salt, it is

reacted with trace metal salts of copper, iron, manganese, or zinc to form a chelate. The petitioner 

manufactures liquid micronutrient chelates using ammonium glycinate as the chelating agent. Chelates 

are used to provide micronutrients that are readily available to plants in deficient soils. 

Ammonium glycinate is manufactured through a reaction of ammonium hydroxide and glycine. The 

petition argues that approval of ammonium hydroxide is understood in the listing of ammonium 

carbonate in §205.601(e)(1) since it is a salt of ammonium hydroxide and carbonic acid (ammonium 

carbonate is listed for use “in insect traps only, no direct contact with crop or soil”). Further, the 

petitioner claims that since lignin sulfonate is listed as a chelating agent in §205.601(j)(4) and because 

OMRI approves the use of ammonium lignosulfonate, ammonium glycinate should be allowed.

The petition states that chelated trace minerals are necessary in high pH soils because the simple metal 

micronutrient salts allowed in §205.601(j)(6)(ii) otherwise need to be applied at four to five times the 

rate of plant up-take because unchelated micronutrients precipitate quickly when they come into 

contact with soils high in pH. Additionally, the petitioner claims that although nonsynthetic chelating 

agents can be produced, they are incompatible with the manufacturing of chelates as a result of 

unpredictable variations in species and composition. 

In addition to the information on Ammonium glycinate, the petition puts forth a case that the use of the 

term “chelating agent” in the regulations needs to be revisited. The petitioner contends that both the 

cation and anion of a salt approved for use as a chelating agent should be on National List. The 

petitioner requests that the NOP define which bases can be used to neutralize acids used to synthesize

chelating agents. However, these claims and request are beyond the purview of this Subcommittee

whose role in this case is the review of substances petitioned for inclusion on the National List. 

Summary of Review: 

Upon review of the petition, the Subcommittee determined that there was insufficient information in 

the justification statement regarding the necessity of the material for organic crop production. The 

Subcommittee sent a request to the petitioner, asking why the petitioned materials would be better 

than the nonsynthetic and/or synthetic chelating agents that are already allowed. The petitioner 

submitted an addendum but still did not completely address the question of alternatives. The 

addendum claims that there are no nonsynthetic substances, nor any substances already on the 

National List, that could be used in place of Ammonium glycinate. The petitioner subsequently 

volunteered a second addendum. 

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Despite the submission of the second addendum, the petitioner did not make a convincing case that the 

permitted products already on the market are inadequate to meet farmers’ needs. The petitioner does 

not provide evidence that chelates made with synthetic glycinate are needed to replace lignin sulfonate 

and nonsynthetic chelating agents such as fulvic acids, humic acids, and nonsynthetic citrate currently in 

use by organic growers.

The Subcommittee did not request a technical review after determining that the petitioned material was

not necessary for organic production. 

The Subcommittee has concluded that the petitioned substance does not meet the OFPA criteria and 

therefore should not be added to the National List.

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or Synthetic? 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. 

No

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)]

Chelates occur in nature and are used at low rates in organic farming, so there should be no 

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)]

Ammonium hydroxide and glycine are introduced in a reaction vessel to produce ammonium 

glycinate, a salt. The amino acid glycine is neutralized by the alkali ammonium hydroxide. 

Ammonium glycinate is reacted in a solution with copper, iron, manganese, or zinc salt to form a 

liquid chelate of the given metal. Chelates are applied in low dosages; application rates for the 

chelates manufactured by the petitioner are 1.2-2.5 kg/ha. 

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3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

The petition states that there is minimal chance of environmental or human contamination 

during the manufacturing process as the reaction takes place inside a sealed vessel. As stated 

above, the petitioned substance is an ingredient in a finished product and is converted into a 

metal salt chelate and is therefore not subject to questions of disposal. However, ammonium 

hydroxide is used in the manufacture of the substance, and ammonium hydroxide is produced 

by the reaction of ammonia with water. Ammonia can be harmful to human health and aquatic 

life if spilled or improperly handled.

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)]. 

The petition states that “in the unlikely event of contact of reaction vessel contents with human 

skin, there is a very low level of hazard as the substance is at a low concentration, is not toxic, 

and can be easily washed off with water”.

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 Subcommittee is not aware of negative effects of the petitioned material on biological and 

chemical interactions in the agroecosystem.

6. Are there any adverse impacts on biodiversity? (§205.200) 

None known.

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)]

Alternatives to the petitioned substance exist and are currently in use, including lignin sulfonate, 

humic acids, fulvic acids, and nonsynthetic citrate. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

Chelates occur naturally in soils, so chelates, per se, are not incompatible with a system of 

sustainable agriculture. However, overreliance on synthetic materials is not compatible with a 

system of sustainable agriculture. The subcommittee has determined that there are insufficient 

grounds for adding this substance to the National List as there are natural alternatives and one 

allowed synthetic already available. 

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Classification Motion: 

 

Motion to classify Ammonium glycinate as synthetic

Motion by: Emily Oakley

Seconded by: Harriet Behar

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

National List Motion: 

Motion to add Ammonium glycinate as petitioned at §205.601

Motion by: Emily Oakley

Seconded by: Harriet Behar

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

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National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Potassium Cellulose Glycolate

August 30, 2016

Summary of Petition: 

Lamberti USA, Incorporated has petitioned for the inclusion of potassium cellulose glycolate on the 

National List at 7 CFR 205.601 (synthetic substances allowed for use in organic crop production) as a 

synthetic inert ingredient. 

Potassium Cellulose glycolate, or Potassium Carboxymethylcelluose (CMC), is a chemically modified

polymer derived from natural cellulose. The petition proposes to utilize Potassium CMC as a water 

filtration aid during irrigation and in combination with liquid fertilizers and nutrients.

Potassium CMC is manufactured from naturally occurring cellulose by replacing one or more reactive 

hydroxyl groups with carboxymethyl groups through etherification. This is achieved by treating cellulose 

with caustic soda to attain the alkali-cellulose complex. This is further reacted with Mono Chloroacetic 

Acid (MCA), and the result is CMC and Sodium Chloride. Sodium Glycolate is formed through a side 

reaction by the caustic soda on MCA. Pure grade CMC is obtained by removing impurities with an 

aqueous solvent treatment. 

Potassium CMC is being petitioned for its water holding properties, delivering water more effectively to 

the plant’s root zone. The petition claims that the material increases drip irrigation efficiency by 

approximately 30-40%.

Summary of Review: 

The Subcommittee determined that water usage is not a criteria under OFPA, and there was insufficient 

information justifying the need for this material in an organic production system. Soil organic matter 

serves to naturally increase water holding capacity and retention. Managing for and fostering soil 

organic matter is a key element in a good organic system plan.

The Subcommittee did not request a technical review after deciding that the petitioned material was 

not necessary for organic production. The Subcommittee determined that the petitioned substance fails 

to meet the OFPA criteria and therefore should not be added to the National List.

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or synthetic? 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. 

Potassium CMC is manufactured from naturally occurring cellulose and undergoes a synthetic 

chemical change.

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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?

Potassium CMC is a List 4 Inert approved for food and nonfood uses. It is a low-risk polymer (40 

CFR 723.250) and is exempted from a requirement of tolerance under FFDCA section 408 when 

used in according with good agricultural practices.

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)]

The petition states that potassium salt is petitioned to avoid increasing soil sodium content. As 

a component of plants, cellulose would not be expected to have detrimental 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)]

The petition relied on test results of carboxymethylcelluose, sodium salt (structurally identical to 

Potassium CMC except for the cation of the salt) as there are no test results available for the 

petitioned material. Average biodegradation rates were above 73%.

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

The petition presented results from EcoToxicological studies on fish and crustacean toxicity for 

carboxymethylcelluose, sodium salt with no toxicity detected.

4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i); 

§6518(m)(4)]. 

Results from acute toxicity tests on rats, short-terms studies on rats, guinea pigs, rabbits, and 

dogs, and long-terms and teratogenicity studies on mice and rats for carboxymethylcelluose, 

sodium salt were shown with minimal or no effects found. The safety data sheet supplied in the 

petition lists no hazard or precautionary statements but does note a European Union special 

provision that the substance may produce an allergic reaction.

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)] 

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The petition presents results from terrestrial toxicity studies measuring bean and corn seed 

exposure to applications carboxymethylcelluose, sodium salt in natural soil media with no 

reported effects.

6. Are there any adverse impacts on biodiversity? (§205.200) 

None known.

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)]

A primary goal of an organic system plan is maintaining or improving soil organic matter content 

through strategic management practices. Conservative tillage and no-till practices increase soil 

organic matter, decrease compaction, minimize water evaporation, and increase rain and 

irrigation water infiltration. Plant, mulch, and cover crop residues can increase water infiltration 

by preventing crusting and conserving water. Incorporated residues and compost improve soil 

fauna, whose activity increases aeration, opens pores, and decreases compaction. In turn, these 

attributes increase water penetration.

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

Synthetic water filtration materials are incompatible with a system of sustainable agriculture. 

Natural alternatives and good soil management practices exist, and water use is not an OFPA 

criteria. The subcommittee does not recommend adding this substance to the National List.

Classification Motion: 

 

Motion to classify potassium cellulose glycolate as synthetic

Motion by: Emily Oakley

Seconded by: Harriet Behar

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

National List Motion: 

Motion to add potassium cellulose glycolate as petitioned at §205.601 

Motion by: Emily Oakley

Seconded by: Harriet Behar

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

135/279
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National Organic Standards Board

Crops Subcommittee Proposal

Hydroponic/Aquaponics/Bioponics 

September 6, 2016

Introduction

The National Organic Program (NOP) established a Hydroponic/Aquaponic Task Force (referred to as 

Task Force throughout) in 2015 to write a report to the National Organic Standards Board (NOSB) on 

whether hydroponic/aquaponic production should be allowed under the current organic regulations; 

and if not, how the regulations could or should be changed. The report was completed in July 20161 and 

now it is up to the NOSB to formulate the input from the report into recommendations.

The issues involved are complicated, not only because of lack of clarity in current regulations, but 

because of a continuum of growing methods for plants in containers and the lack of a clear set of 

definitions around containers, growing media, soil, and other terms both in the regulations and in 

general. Also, there have been contradictory statements from the NOSB in the past and gaps in the 

NOSB recommendations, which have resulted in gray areas that the NOP does not know how to address 

in rulemaking.

All of the ramifications are going to take time to sort through and work out by the NOSB Crops 

Subcommittee, with stakeholder input along the way. We have chosen to break this into three potential 

components or sections so that we can take a systematic approach to this complex issue. Two of the 

components will be presented at the Fall 2016 NOSB meeting while the third may be drafted in pending

the outcome of the Part 1 proposal. For the purposes of moving forward with uniform terminology, from 

here on we will use the term "Bioponics," as suggested by the Task Force, to refer to the combined term 

"Hydroponic/Aquaponic" systems currently employed by organic hydroponic/aquaponics producers. 

• Part 1 (this part) is whether Bioponics fits into the Organic Foods Production Act (OFPA) and the 

USDA organic regulations in CFR Part 205 (referred to throughout as the NOP rule). This is a 

proposal that will go before the NOSB in Fall 2016.

• Part 2 is a Discussion Document on container systems for solid substrates, including which ones 

could or should be allowed under the existing NOP Rule and/or which would require a change in 

the Rule, along with suggestions for what changes need to be made.

• Part 3 will be a Discussion Document on the standards needed for bioponic systems to be 

allowed under the NOP organic rules, along with possible limits on what sort of systems would 

qualify as Bioponics. This will occur for spring 2017 if the proposal in part 1 passes.

Background

The NOSB has made several past recommendations on the subject of greenhouse production, which 

have relevance to this discussion. In a 1995 Standards for Greenhouses recommendation, the following 

statement is made:

“Hydroponic production in soilless media to be labeled organically produced shall be allowed if 

all provisions of the OFPA have been met.”

This was before there was an NOP rule so the NOSB only had OFPA to guide them.

1 Hydroponic and Aquaponic Task Force Report, July 2016

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In 2010 the NOSB issued a recommendation titled Production Standards for Terrestrial Plants in 

Containers and Enclosures (Greenhouses). While this mostly focused on greenhouse production in 

containers with solid growing media, the following statement is made:

"Observing the framework of organic farming based on its foundation of sound management of 

soil biology and ecology, it becomes clear that systems of crop production that eliminate soil 

from the system, such as hydroponics or aeroponics, cannot be considered as examples of 

acceptable organic farming practices. Hydroponics" “...cannot be classified as certified organic 

growing methods due to their exclusion of the soil-plant ecology intrinsic to organic farming 

systems and USDA/NOP regulations governing them.”

Furthermore, in 2009 a document titled Soil-less Growing Systems Discussion Item contains the 

following statement:

"In previous Crops Committee discussion documents, the question has been asked: “Should 

container culture based growing media (typically utilized in greenhouse systems) that are 

predominately compost and compostable plant materials be considered ‘soil’?". As highlighted 

in earlier portions of this document, a foundational principle of organic farming is the practice of 

maintaining and nurturing soil health so as to foster the proliferation of the proper soil biology 

with their accompanying ecologies. Since all typical soil dwelling organisms, such as earthworms, 

insects, arachnids, protozoa, fungi, bacteria, and actinomycetes can thrive in a properly 

designed compost based growing media, producing the beneficial symbiotic ecological 

relationships found in soil, such growing media should be rightfully considered soil." 

At the first meeting of the Hydroponic/Aquaponic Task Force in January 2016, the NOP presented 

information on where they thought there were gaps and inconsistencies in the past NOSB 

recommendations, both for hydroponics and for greenhouse growing systems in general. Their 

presentation included the following statement: "Further analysis and clarification is necessary because 

regardless of what position the NOSB ultimately takes on the issue of hydroponics and aquaponics, the 

NOP will likely need to undertake rulemaking. Rulemaking requires a comprehensive recommendation 

from the NOSB that addresses grey (sic) areas left by past recommendations." 

The gray areas and gaps include the following (paraphrased from original):

• A clear explanation of the basis for each recommendation made.

• Acknowledging the continuum of production methods from field/soil to hydroponic and the role 

of compost or other biological growing media. Recommendations on each type of production 

and reasons for allowing or prohibiting.

• Guidelines are needed on exactly how different production types comply with provisions in 

regulations for soil fertility, rotation, and cover cropping.

• Definitions of vague terms including container, hydroponics, soil-less media, "compost-based", 

and soil ecology.

• How are OFPA and the NOP rule able to be consistent on other soilless production such as 

mushrooms, sprouts, aquatic plants and greenhouse in-ground systems?

• What is the justification for requiring soil (as opposed to cycling of resources, promoting 

ecological balance, and conserving biodiversity) but making an exception for cover crops, crop 

rotation, etc. when soil is not explicitly required in the regulations, but crop rotation is

mandatory? 

• Aquaponic systems are not specifically addressed in previous NOSB recommendations. 

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The lengthy report from the Task Force contains a lot more background information which is too 

extensive to cover here. Selected portions will be referenced below in the discussion section.

Relevant areas in the Rule

Organic Food Production Act (OFPA)

§6504. National standards for organic production 

To be sold or labeled as an organically produced agricultural product under this chapter, an agricultural 

product shall— 

(1) Have been produced and handled without the use of synthetic chemicals, except as 

 otherwise provided in this chapter; 

(2) Except as otherwise provided in this chapter and excluding livestock, not be 

 produced on land to which any prohibited substances, including synthetic chemicals, 

 have been applied during the 3 years immediately preceding the harvest of the 

 agricultural products; and 

(3) Be produced and handled in compliance with an organic plan agreed to by the 

 producer and handler of such product and the certifying agent. 

§6512. Other production and handling practices 

If a production or handling practice is not prohibited or otherwise restricted under this chapter, such 

practice shall be permitted unless it is determined that such practice would be inconsistent with the 

applicable organic certification program. 

§6513. Organic plan 

... (b) Crop production farm plan

(1) Soil fertility

An organic plan shall contain provisions designed to foster soil fertility, primarily through the 

management of the organic content of the soil through proper tillage, crop rotation, and 

manuring. ...

.... (g) Limitation on content of plan

An organic plan shall not include any production or handling practices that are inconsistent with 

this chapter. 

§6519. Recordkeeping, investigations, and enforcement

(c) Violations of chapter 

(1) Misuse of label.... (2) False statement.... (3) Ineligibility 

National Organic Program Rule 

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§205.2 Terms defined. 

Crop rotation. The practice of alternating the annual crops grown on a specific field in a planned pattern 

or sequence in successive crop years so that crops of the same species or family are not grown 

repeatedly without interruption on the same field. Perennial cropping systems employ means such as 

alley cropping, intercropping, and hedgerows to introduce biological diversity in lieu of crop rotation.

Field. An area of land identified as a discrete unit within a production operation.

Organic production. A production system that is managed in accordance with the Act and regulations in 

this part to respond to site-specific conditions by integrating cultural, biological, and mechanical 

practices that foster cycling of resources, promote ecological balance, and conserve biodiversity.

§205.202 Land requirements. 

Any field or farm parcel from which harvested crops are intended to be sold, labeled, or represented as 

“organic,” must: (a) Have been managed in accordance with the provisions of §205.203 through 

205.206; 

§ 205.203 Soil fertility and crop nutrient management practice standard. 

(a) The producer must select and implement tillage and cultivation practices that maintain or 

 improve the physical, chemical, and biological condition of soil and minimize soil erosion.

(b) The producer must manage crop nutrients and soil fertility through rotations, cover crops, 

 and the application of plant and animal materials.

(c) The producer must manage plant and animal materials to maintain or improve soil organic 

 matter content in a manner that does not contribute to contamination of crops, soil, or water 

 by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited 

 substances.... 

§205.205 Crop rotation practice standard. 

The producer must implement a crop rotation including but not limited to sod, cover crops, green 

manure crops, and catch crops that provide the following functions that are applicable to the operation:

(a) Maintain or improve soil organic matter content;

(b) Provide for pest management in annual and perennial crops;

§205.208 - 205.235 [Reserved] 

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Discussion

First and foremost, a standardized set of definitions must be adopted to discuss this successfully. 

Therefore a glossary is appended here of some of the most common definitions taken from the NOSB 

2010 Recommendation and the Task Force Report, amended for this proposal. 

The writers of OFPA were wise enough to leave many issues somewhat open-ended so that regulations 

could evolve over time. OFPA also contains several statements that can be perceived to conflict with 

each other. It then falls to the writers of the regulations to sort through the provisions to develop 

specific standards. Such is the case with §6512 cited above. This implies that since soil is not specifically 

mandated, and lack of soil is not specifically prohibited, such practices could be permitted if regulations 

were written to support them. This is in part what led to the 1995 NOSB statement that hydroponics 

could potentially be allowed if OFPA requirements were met, and this would be, through regulations, 

specific to how hydroponic systems are consistent with the rest or organic production. The 1995 NOSB 

realized that, at that time, hydroponics could not meet the requirements of OFPA, but wanted to leave 

the door open for future discussions.

The NOP rules as written do not have specific provisions for many specialized areas of production, 

including mushrooms, aquatic plants, greenhouse, container growing, apiary, or fish. Some of these 

have been promised for a long time. All of them involve alternative provisions to some of the current 

clauses in the regulation. In anticipation of this, sections 205.208 - 205.235 were put in as reserved. 

Under the umbrella of OFPA, such regulations could be recommended by the NOSB and then regulations 

written by the NOP (in the future). In the meantime there are certifiers who have figured out how to 

certify these operations, presumably with NOP oversight.

The 2010 NOSB made it very clear that they did not believe that hydroponic systems, as they 

understood them, were compatible with organic production and therefore they recommended that 

rules be written for "Terrestrial Plants in Containers and Enclosures" but not for hydroponics. They 

based this decision on the opinion that soil-plant ecology is intrinsic to organic farming systems and 

USDA/NOP regulations. However there were key gaps in their position: 

• Using the parameter of a compost-based growing media without definition of how much 

compost or how much growing media. Also, there was no definition of soil provided. 

• Not recognizing the similarities between crops grown to maturity in containers and hydroponic 

systems. There is a continuum in container production from plants getting nutrition from the 

growing media to plants solely getting nutrition from liquid sources. There needs to be specific 

parameters for growing media components and liquid-based nutrition in organic container 

systems. 

• Not giving adequate reasons for why other soilless productions, such as aquatic plants, 

mushrooms or sprouts could be organic but not hydroponics.

• Proposing to exempt greenhouse production from crop rotations and cover cropping but not 

exempt hydroponics with enough reasons. 

The decision before the NOSB now is whether to uphold the 2010 recommendation and fill in the gaps 

so that rulemaking can proceed on greenhouses and/or containers for solid growing media, or to make 

recommendations that would lead to rulemaking regarding what types of "bioponic" systems might be 

compatible with organics and what standards are needed to assure that they are.

Since either decision means that there is still a lot of work to do, we are putting forward a discussion 

document on how to "fill the gaps" by: justifying greenhouse production in the regulations, defining 

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containers and compliant growing media, discussing provisions of the NOP rule regarding natural 

resources, land use, rotations and nutrition, and where to draw the line in the continuum for containers.

It is worth noting that in 2016 there are 52 certified organic hydroponic/aquaponic operations and 69 

certified operations who grow crops in containers.

Advantages of Bioponics

As is pointed out in the Task Force report, bioponics has a long history in agriculture from societies that 

worked with limited resources in changing conditions. It has always involved innovation and shares 

many of the same principles behind organic farming such as recycling, water efficiency, and eliminating 

the use of toxic pesticides. It is an appropriate way to address challenges in farming as a whole, such as 

drought, food safety, limited arable land, and climate change. Practitioners have developed some 

wonderful systems that are fully integrated, use only materials on the National List and depend 

extensively on microbial action to provide plant health and nutrition. The introduction of fish to create 

an aquaponic system is especially creative, since it can address production of a protein source and 

integrate in situ fertilizer production to an integrated system.

In the Organic Integrity Quarterly from May 2014, a publication from NOP, they note that organic 

hydroponic production is allowed as long as the producer can demonstrate compliance with the USDA 

organic regulations. The Bioponics proponents of the Task Force cited this and the fact that certifiers are 

accepting Organic System Plans for such operations as approval. However the article does state that 

there may be additional guidance issued in the future for these methods.

The Task Force elaborated on the advantages of these systems, focusing on water conservation, 

increased food safety, disease suppression, nutrient conservation and retention, and soil conservation 

(because of not using any). They point out that most areas of the rules can be followed as written, 

including writing and implementing an Organic System Plan, keeping records, preserving natural 

resources, and using compliant inputs.

The justifications for how bioponic systems comply with §205.203 (soil fertility and crop nutrients) and 

§205.205 (rotations) are as follows (see rule wording above):

• §205.203 (a) – the lack of tillage and extraction of nutrients from soil is also a way to improve or 

maintain soil.

• §205.203 (b) – crop nutrient management and growing media fertility can be maintained 

without contributing to contamination by allowing proliferation of active biology which is 

equivalent to rotation, or cover crops.

• §205.203 (c) – contamination is avoided by growing in a controlled system and having compliant 

practices in place for discharges.

• §205.205 – rotation is accomplished by renewal of growing media at the end of each crop cycle 

or as appropriate for each crop. "As bioponic systems do not impact the soil organic matter 

below the system as would an in-ground crop, it is expected that the requirement of rotations 

and cover crops to maintain or improve such surrounding soil organic matter would be 

inapplicable to bioponic production." (Task Force report, p. 149). 

The bioponics proponents of the Task Force have supplied language for a suggested rule change to 

§205.2 Terms defined and a new section §205.208 Bioponic Production Standard. Depending on the 

outcome of the vote below, we may need another discussion document on bioponic production, 

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including justification for it to be written into the rules and consistency with the "applicable organic 

certification program" (§6512 OFPA), as well as specific parameters and standards that apply regarding 

systems, growing media, "crop rotation", and possibly labelling. 

Arguments against Hydroponics/Bioponics 

Natural soils are generally about 95% (plus or minus) mineral matter by weight. Soil mineral particles 

(clay, silt and sand) are intimately intertwined and complexed with soil organic matter. This 

mineral/organic matter soil system provides habitat and food sources for soil microorganisms and 

creates pore spaces in soils for storing water and for air exchange with the atmosphere. The clay/humus 

complexes also serve a primary function of holding soil nutrients in reserve for plant uptake. 

The maintenance and regeneration of this complex, living soil system is a biological process that requires 

continual recycling of organic materials within the soil system. Crop rotations and cover crops are also 

important to create and maintain healthy soils, which contribute to healthy plants. It is this complex soil 

system that pioneer organic farmers learned to work with and optimize, in contrast to the prevalent 

industrial, input-based model of agriculture that they rejected. Early organic certification standards 

reflected this system and required on-farm practices and use of materials that fostered soil health by 

means of managing crop residue, using livestock manures, composting, cover cropping and adding 

natural rock powders. (Task Force report p. 14). For this reason, many organic producers reject 

hydroponic and bioponic systems that are input-based rather than soil-based. Also, when bioponic 

operations pave over soil with cement or gravel, soil conservation goals are not met.

Loss of arable land and the need to feed a growing world population are also cited by the pro-bioponic 

advocates. Organic agriculture, with its focus on soil building and protection or enhancement of natural 

resources, offers the opportunity to continually improve land and other natural resources while 

producing crops, as well as transform land, which has been degraded by poor farming practices or is of 

low productive capability, to sustainable farming systems. While production of the crop in a bioponic 

system can require less water to grow the crop than field growing, this ignores the earth’s water cycle, 

where “excess” water is not lost or wasted, but is continually recycled either by recharging the ground 

water resource or evaporating into vapor to produce rain, snow or fog. Lastly, unless there is careful 

attention paid to managing water runoff when siting and building hoop houses or greenhouses, the 

potential for soil erosion can be extreme. There are some areas of the United States, specifically 

California, which have experienced severe soil loss problems where many hoop houses are present.

 

Recommendation

The USDA/NOP regulations require proper stewardship toward improving and maintaining the soil 

ecology within an organic farming system for terrestrial plant production. Therefore the NOSB supports 

the decisions by previous boards by recommending that hydroponics, aeroponics, bioponics or 

aquaponics are not consistent with organic production due to their exclusion of the soil-plant ecology 

intrinsic to organic farming systems. We believe that action from this board would be needed to 

overturn the previous recommendation of the NOSB in 2010, and therefore the motion as worded 

would require a 2/3 majority. 

The NOSB plans to work further on defining the systems and practices that are allowed, and delineating 

what is not allowed with regard to containers for solid substrate and growing media. 

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Committee Vote

Motion to allow bioponics (including hydroponics, aeroponics, or aquaponics) as consistent with organic 

production under the provisions and recommendations to be developed by the NOSB in 2017.

Motion by: Zea Sonnabend

Seconded by: Emily Oakley

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

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Glossary of terms 

Source in (Parentheses)

Aquaponics – A system in which plants are grown in waste water from aquatic organisms, which in turn 

purifies the water. (Task Force Report)

Aeroponics – A variation of hydroponics in which plant roots are suspended in air and misted with 

nutrient solution. (2010 NOSB Recommendation)

Bioponics – A contained and controlled growing system in which plants in growing media derive 

nutrients from natural animal, plant and mineral substances that are released by the biological activity 

of microorganisms and delivered in water. (Task Force Report with slight modification by CS)

Compost – The product of a managed process through which microorganisms break down plant and 

animal materials, including allowed feedstock materials (either nonsynthetic substances not prohibited 

at § 205.602, or synthetics approved for use as plant or soil amendments), into more available forms 

suitable for application to the soil. Compost must be produced through a process that combines plant 

and animal materials with an initial C:N ratio of between 25:1 and 40:1 and processes it to a low final 

C:N ratio (in the range of 5:1 to 20:1). Producers using an in-vessel or static aerated pile system must 

maintain the composting materials at a temperature between 131 °F and 170 °F for 3 days. Producers 

using a windrow system must maintain the composting materials at a temperature between 131 °F and 

170 °F for 15 days, during which time, the materials must be turned a minimum of five times. (USDA 

organic rule)

Compost Tea – A water extract of compost produced to transfer microbial biomass, fine particulate 

organic matter, and soluble chemical components into an aqueous phase, intending to maintain or 

increase (it may be brewed) the living, beneficial microorganisms extracted from the compost. (Task 

Force Report)

Container – Any vessel and associated equipment used to house growing media and the complete root 

structure of terrestrial plants and to prevent the roots from contacting the soil or surface beneath the 

vessel, such as, but not limited to, pots, troughs, plastic bags, floor mats, etc. (Task Force Report)

Greenhouse – Permanent enclosed structure that allows for an actively controlled environment used to 

grow crops, annual seedlings or planting stock. (2010 NOSB Recommendation)

Hydroponics – The growing of normally terrestrial vascular plants in mineral nutrient solutions with or 

without an inert growing media to provide mechanical support. (Hybrid definition adopted by CS from 

Task Force report)

Growing media – Material which provides sufficient support for the plant root system and enables the 

plant to extract water and nutrients. Used interchangeably with the term "substrate". (Adopted by CS 

from Task Force and internet sources)

Microbial solution – Growing solution used in bioponic production which is commonly composed of 

organic substances and a diverse ecosystem of beneficial microorganisms in water. (Task Force Report)

Nutrient solution – Growing solution used in traditional hydroponic production which is commonly 

composed of immediately plant-available soluble synthetic mineral salts in water (Task Force Report)

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Soil – The outermost layer of the earth comprised of minerals, water, air, organic matter, and living 

organisms, in which plants grow. (Modified from Task Force Report)

Soil Ecology – A term used to describe the incredible diversity of organisms that live in the soil and the 

complex interactions between them that contribute to plant nutrition and plant and soil health. They 

range in size from the tiniest one-celled bacteria, algae, fungi, and protozoa, to the more complex 

nematodes and microarthropods, to the visible earthworms, insects, small vertebrates, and plants. 

(Hybrid definition adopted by CS from Task Force report)

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National Organic Standards Board

Crops Subcommittee

Discussion Document

Container and greenhouse production: further clarifications

September 6, 2016

Introduction

Regardless of how a recommendation on bioponic comes out, the NOP has said that they do not have 

enough clarity to write rules for crops grown in greenhouses or containers with solid substrate. This 

Discussion Document will look at the gaps and inconsistencies in the 2010 NOSB recommendation on 

Production Standards for Terrestrial Plants in Containers and Enclosures (Greenhouses) to fill in those 

gaps and justify the unresolved points.

The goal is to examine what is needed for growing plants to maturity in containers in order to be 

consistent with the organic regulations, to create definitions and standards for terms that were not 

precisely spelled out in the 2010 recommendation, and to create a stage for further rulemaking efforts if 

needed. 

Each point below has a discussion section in which options and opinions from the Task Force report are 

mentioned. The Discussion Questions posed request public comment on which policy option or 

standards are preferred and why.

Background

The NOSB has made several past recommendations on the subject of greenhouse production which 

have relevance to this discussion. In a 1995 Standards for Greenhouses recommendation, the following 

statement is made:

Hydroponic production in soilless media to be labeled organically produced shall be allowed if all 

provisions of the OFPA have been met.

This was before there was an NOP rule so the NOSB only had OFPA to guide them.

In 2010 the NOSB issued a recommendation titled Production Standards for Terrestrial Plants in 

Containers and Enclosures (Greenhouses). While this mostly focused on greenhouse production in

containers with solid growing media, the following statement is made:

Observing the framework of organic farming based on its foundation of sound management of 

soil biology and ecology, it becomes clear that systems of crop production that eliminate soil

from the system, such as hydroponics or aeroponics, cannot be considered as examples of 

acceptable organic farming practices. Hydroponics" “...cannot be classified as certified organic 

growing methods due to their exclusion of the soil-plant ecology intrinsic to organic farming 

systems and USDA/NOP regulations governing them.

Furthermore, in 2009 a document titled Soil-less Growing Systems Discussion Item contains the 

following statement:

In previous Crops Committee discussion documents, the question has been asked: “Should 

container culture-based growing media (typically utilized in greenhouse systems) that are 

predominately compost and compostable plant materials be considered ‘soil’?" As highlighted in 

earlier portions of this document, a foundational principle of organic farming is the practice of 

maintaining and nurturing soil health so as to foster the proliferation of the proper soil biology 

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with their accompanying ecologies. Since all typical soil dwelling organisms, such as earthworms, 

insects, arachnids, protozoa, fungi, bacteria, and actinomycetes can thrive in a properly 

designed compost-based growing media, producing the beneficial symbiotic ecological 

relationships found in soil, such growing media should be rightfully considered soil.

At the first meeting of the Hydroponic/Aquaponic Task Force in January 2016, the NOP presented 

information on where they thought there were gaps and inconsistencies in the past NOSB 

recommendations, both for hydroponics and for greenhouse growing systems in general. Their 

presentation included the following statement, "Further analysis and clarification is necessary because 

regardless of what position the NOSB ultimately takes on the issue of hydroponics and aquaponics, the 

NOP will likely need to undertake rulemaking. Rulemaking requires a comprehensive recommendation 

from the NOSB that addresses grey (sic) areas left by past recommendations." 

The gray areas and gaps include the following (paraphrased from original):

• A clear explanation of the basis for each recommendation made.

• Acknowledging the continuum of production methods from field/soil to hydroponic and the role 

of compost or other biological growing media. Recommendations on each type of production 

and reasons for allowing or prohibiting.

• Guidelines are needed on exactly how different production types comply with provisions in 

regulations for soil fertility, rotation, and cover cropping.

• Definitions of vague terms including container, hydroponics, soil-less media, "compost-based", 

and soil ecology.

• How are OFPA and the NOP rule able to be consistent on other soilless production such as 

mushrooms, sprouts, aquatic plants and greenhouse in-ground systems?

• What is the justification for requiring soil (as opposed to cycling of resources, promoting 

ecological balance, and conserving biodiversity) but making an exception for cover crops, crop 

rotation, etc. when soil is not explicitly required in the regulations, but crop rotation is 

mandatory? 

• Aquaponic systems are not specifically addressed in previous NOSB recommendations. 

The lengthy report from the Task Force contains a lot more background information which is too 

extensive to cover here. Selected portions will be referenced below in the discussion section.

Relevant areas in the Rule

Organic Food Production Act (OFPA)

§6504. National standards for organic production 

To be sold or labeled as an organically produced agricultural product under this chapter, an agricultural 

product shall— 

(1) have been produced and handled without the use of synthetic chemicals, except as 

otherwise provided in this chapter; 

(2) except as otherwise provided in this chapter and excluding livestock, not be produced on 

land to which any prohibited substances, including synthetic chemicals, have been applied 

during the 3 years immediately preceding the harvest of the agricultural products; and 

(3) be produced and handled in compliance with an organic plan agreed to by the producer and 

handler of such product and the certifying agent. 

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§6512. Other production and handling practices 

If a production or handling practice is not prohibited or otherwise restricted under this chapter, such 

practice shall be permitted unless it is determined that such practice would be inconsistent with the 

applicable organic certification program. 

§6513. Organic plan 

... (b) Crop production farm plan

(1) Soil fertility

An organic plan shall contain provisions designed to foster soil fertility, primarily through the 

management of the organic content of the soil through proper tillage, crop rotation, and 

manuring. ...

.... (g) Limitation on content of plan

An organic plan shall not include any production or handling practices that are inconsistent with 

this chapter. 

§6519. Recordkeeping, investigations, and enforcement

(c) Violations of chapter 

(1) Misuse of label .... (2) False statement .... (3) Ineligibility 

National Organic Program Rule 

§205.2 Terms defined. 

Crop rotation. The practice of alternating the annual crops grown on a specific field in a planned pattern 

or sequence in successive crop years so that crops of the same species or family are not grown 

repeatedly without interruption on the same field. Perennial cropping systems employ means such as 

alley cropping, intercropping, and hedgerows to introduce biological diversity in lieu of crop rotation.

Field. An area of land identified as a discrete unit within a production operation.

Organic production. A production system that is managed in accordance with the Act and regulations in 

this part to respond to site-specific conditions by integrating cultural, biological, and mechanical 

practices that foster cycling of resources, promote ecological balance, and conserve biodiversity.

§205.202 Land requirements. 

Any field or farm parcel from which harvested crops are intended to be sold, labeled, or represented as 

“organic,” must: (a) Have been managed in accordance with the provisions of §205.203 through 

205.206; 

§ 205.203 Soil fertility and crop nutrient management practice standard. 

(a) The producer must select and implement tillage and cultivation practices that maintain or improve 

 the physical, chemical, and biological condition of soil and minimize soil erosion.

(b) The producer must manage crop nutrients and soil fertility through rotations, cover crops, and the 

 application of plant and animal materials.

(c) The producer must manage plant and animal materials to maintain or improve soil organic matter

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content in a manner that does not contribute to contamination of crops, soil, or water by plant 

nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances.... 

§205.205 Crop rotation practice standard. 

The producer must implement a crop rotation including but not limited to sod, cover crops, green 

manure crops, and catch crops that provide the following functions that are applicable to the operation: 

(a) Maintain or improve soil organic matter content; 

(b) Provide for pest management in annual and perennial crops; 

......

§205.208 - 205.235 [Reserved] 

Discussion

First and foremost, a standardized set of definitions must be adopted in order to have a successful 

discussion. Therefore a glossary is appended here of some of the most common definitions taken from 

the NOSB 2010 Recommendation and the Task Force Report. Definitions taken from these two 

documents may be slightly amended for this discussion. 

1. Consistency with mushrooms, aquatic plants, seedlings, and other "soilless" culture.

The Task Force report points out the following: 

From this subcommittee’s perspective, the recommendation could be bettered, and more easily 

accepted by the NOP, if it explained how each of these exceptions to the premise that crops be 

grown in soil; 1) are linked to soil, or 2) are not naturally living or growing in soil so there is no 

reason for farming them in soil. Furthermore, how each meets the Principles of Organic 

Production and Handling (NOSB, 2001) should be made clear.

They continue by pointing out that sprouts and wild harvest aquatic plants are addressed in the current 

organic regulations, and that the preamble to the final rule specifically states that additional standards 

would be needed for mushrooms and greenhouses.

The CS concurs with this analysis. Sprouting seeds is similar to a processing step for an organic product. 

Therefore the ingredient (seeds) must be certified organic. There are no inputs to the seeds to make 

them grow besides water which is an exempt handling ingredient. . The essential elements otherwise 

needed for plants to complete their lifecycle are not added because all the nutrition they need to the 

point of harvest is provided by the seed.

Wild Aquatic plants are covered under the wild crop section of the rules and the preamble specifically 

points out that the term "site" was used to replace "from land" in the proposed rule. This clarifies that 

wild aquatic plant certification was intended. However, there is now a large amount of aquatic plant 

farming occurring that would not be considered wild, and this is not covered in the current rules.

Seedlings, or transplants, are also specifically mentioned in the organic rules and must be certified 

organically grown, but are considered acceptable if raised in soil-less media. These are future crops that 

will spend most of their time growing in soil and the time to produce the transplant is short compared to 

the time in the ground.

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Mushrooms are fungi, not plants, and that justifies that they don't have a direct link to soil. They are 

more similar to yeasts and microorganisms that may be grown on substrate that does not depend on 

minerals from soil. The parameters of their production may eventually need additional rulemaking but 

so far many mushrooms are able to be certified organic under the existing rules.

Cultivated plants in aquatic systems do not appear to be specifically allowed in the existing rules. This is 

true for both bioponic systems and cultivated aquatic plants in bodies of water.

2. Land Considerations and Natural Resources

Regardless of where the container production is occurring, the land underneath the containers and the 

surrounding environment must be considered. The land underneath an outdoor operation must comply 

with the same provisions of the rule regarding land history and transition as other land. It must also be 

maintained or improved with respect to avoiding contamination. Land that has a building on top of it 

with an impermeable floor must comply with whatever practices are adopted for greenhouse or 

enclosure production.

The Task Force asked the NOSB to consider limiting the use of land where crops could be grown in the 

soil from being converted to container production. It also recommended limiting the conversion of nonorganic container plants to organic by re-potting them in organic growing media.

Natural Resource conservation includes the resources of soil and water and wildlife. This must be 

addressed in an Organic System plan for a container growing system. This includes maintaining the 

condition of land underneath the container production, fate of any water or nutrient run-off from 

container production, and any positive actions taken to encourage biodiversity such as installing 

hedgerows, planting insectary plants amongst the containerized crop plants, and other similar 

techniques.

3. Rotation

The NOSB 2010 recommendation noted that the intent of the rotation and cover cropping clauses in the 

rule could be met by similar practices with the same functions or goals as the crop rotation that are 

applicable to the operation. Such techniques might include mulching, replacing growing media (thus 

replenishing the soil system), planting hedgerows, adding microbial inoculants to stimulate existing 

populations, and recycling and composting used growing media. It was noted by the Task Force that the 

crop rotation requirement is already not enforced by some certifiers on greenhouse crops grown in soil 

and on perennial crops with limited water.

Canadian standards 7.5.12: “Soil regeneration and recycling procedures shall be practiced. The 

following alternatives to crop rotation are permitted: grafting of plants onto disease-resistant rootstock, 

freezing the soil in winter, regeneration by incorporating biodegradable plant mulch (for example, straw 

or hay), and partial or complete replacement of greenhouse soil or container soil, provided it is re-used 

outside the greenhouse for another crop.” 

4. Containers & Growing Media

The 2010 NOSB recommendation on Terrestrial Plants in Containers does partially address production in 

containers. It specifies that the substrate in the container be based on compost and re-iterates the 

previous NOSB opinion that compost was equivalent to soil (see Background section from Bioponics 

proposal).

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The weakness of the 2010 recommendation was that it didn't quantify "compost-based", nor did it put 

any limits on the volume of solid material that would be sufficient in a container in order for there to be 

an equivalent amount of biological activity occurring to the activity occurring in the ground. There was 

also no recognition of whether non-synthetic, carbon-based materials such as coir or peat moss could 

serve the same functions as soil in a container, especially over time and if inoculated with a diverse 

biological microbial population.

The statement from OFPA that fertility come "primarily through the management of the organic content 

of the soil" has been interpreted to mean that soluble fertilizers should not be the primary source of 

nutrients, but only a supplement to an overall program focused on crop rotations and amending with 

compost or manure. This is reflected consistently throughout NOSB recommendations from the past, 

from limitations on sodium nitrate or potassium chloride, to many rejected petitions that were 

requesting the addition of more soluble forms of nutrients to the National List. 

In order to specify an appropriate size of container or characteristics of the growing media that are 

appropriate for organic production, there needs to be a comparison of the characteristics of container 

system vs. the soil system. The Task Force uses Bulk Density as a viable comparison factor. Mineral soils 

have a bulk density of 1.3 grams per cubic centimeter (g/cm3

), while peat or coir-based media have a 

bulk density of only 0.13 g/cm3

, or one-tenth the bulk density of mineral soils. As compost or other high 

organic matter materials are added to peat or coir, the bulk density of the media will typically increase, 

along with the nutrient holding capacity.

A raised bed which has a liner between it and the ground is considered a container, even if the growing 

media is a foot deep. However, containers as referred to in this discussion are limited to those 

containing a solid substrate only. Liquid substrate containers are covered by the overall bioponics 

proposal/recommendation.

By making the containers large enough, the nutrients in the organic matter fraction will be able to 

supply the majority of nutrition for the plant. What is large enough? And how can it be explained in a 

way that is appropriate for different plants? The Task Force cites the work of Dr. Martine Dorais of Laval 

University and the Agassiz Research and Development Centre. At a volume of 100 to 180 liters of soil per 

m2

, Dr. Dorais has demonstrated that no liquid feeding is necessary, and fertility can be provided by the 

biological activity of the growing medium in the beds. 

Both Canada and Sweden permit container growing while requiring minimum soil volumes based on 

growing area. Canada requires a minimum soil volume of 70 liters1 per m2 of growing area. For staked 

crops like tomatoes and peppers they require at least 10% compost at the start of production and 

containers must be at least 30 cm (12 inches) high. They state in section 7.5.4: “Soil used in a container 

system, with the exception of transplants, shall provide nutrients to plants continuously. The soil 

(growth media) shall contain a mineral fraction (sand, silt or clay) and an organic fraction; it shall 

support life and ecosystem diversity.” 

The Canadian standards do not specify an amount of compost or soil for other crops such as lettuce or 

blueberries. They do not account for breakdown and settling of soil volume, it is unclear how certifiers 

can measure the soil volume, and the term "growing area" is not well defined.

In Sweden they require at least 30 liters of soil per m2 for annual crops with long seasons and 0.2 liters 

per pot for other plants such as herbs, lettuce and strawberries.

1 For reference a 5-gallon pot holds 25 liters and a 10-gallon pot holds 40 liters.

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The Task Force report states, "(t)ransplant and container growing methods would have more clarity if 

container growing media had a defined initial and temporal water and nutrient holding capacity and 

biology carrying capacity." It is possible to have a compost- or soil-based growing media with adequate 

aeration and water holding capacity that can provide enough fertility for production of annual plant 

crops or a season in the growth of perennial plants. 

The Task Force Subcommittee that reviewed the 2010 NOSB recommendation is recommending that 

organic growing media must have a minimum of 20% compost.

In presentations given to the Task Force, it was mentioned that coir-based media amended with 

compost or compost tea can partially decompose into substrate with a high nutrient holding capacity 

similar to compost. No research on this has been presented, but over time, the bulk density of the 

media could increase along with microbial diversity. It might be appropriate to require only 5 or 10% 

compost in a coir-based media for perennial plants, which would more closely mimic a soil system that

rarely has as much as 10% organic matter.

5. Nutrition

The Task Force Report states, "(t)he key distinction between organic fertility management and 

conventional fertility management is that in organic the source of the bulk of the crop nutrients are 

from the biological activity decomposing complex organic molecules (compost, manures, seed meals, 

etc.) and the mineral fractions." Soil is important due to the interactions of the physical, chemical and 

biological properties together.

While the bioponics systems are sustainable in regards to nutrient recycling and water conservation, 

they do not have the complex interactions found in an organic soil-based system. The backbone of 

organic production is the complex interactions between soils, plants, animals and humans. 

It would seem logical to assess the continuum between grown in the ground and fully liquid based 

systems by determining where the plant nutrition is coming from. If the nutrients are primarily coming 

from the "soil" or approved growing media and solid amendments, then they would be considered 

equivalent to in-ground production. Whereas a container production system that relies primarily on 

liquid fertilizers would not be within the requirement for soil-based systems.

The NOSB recognizes that some soils contain very little inherent fertility and crops are being grown and 

certified organic which rely in large part on liquid fertilizers. While this is an area that should perhaps be 

enforced more vigorously, this is outside the scope of this attempt to set standards for crops grown in 

containers. In order for container production to be certified organic, there may have to be greater 

efforts made than for growing crops in soil.

If there is a minimum soil volume requirement created to provide most nutrition from the soil, there 

may still need to be a limit set to how much of the plant's needs can be supplied by soluble liquid 

nutrients. For instance, the Soil Association in Britain limits the amount of nutrients that can be added 

after planting to no more than 50% of the total nutrients required. This applies to crops grown in the 

ground. Other standards for greenhouses limit liquid nutrients to 25% of the total nutrients supplied. A 

brand new revision to the Canadian standards2 also proposes limits on liquid fertilizers by stating that 

2 2016 amended draft of Canada Organic Standards, pp 44-45: General Principles and Management Standards

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for small soil volumes there must be 70% of the nitrogen and phosphorus supplied by solid organic soil 

amendments that require an active soil ecosystem. 

The Task Force Subcommittee that reviewed the 2010 recommendation is recommending that liquid 

nutrients be limited to 20% of the total nutrients supplied. No reasoning is given for being lower than 

the international standards in use.

The bioponics proponents claim that the mineralization of nutrients into forms that plants can take up is 

performed by microbial digestion in a bioponic system and that the microbial population and dynamics 

are equivalent to a "diverse soil ecology". The Crops Subcommittee questions this statement because no 

solid information was provided about the specific microbes and their roles, and because saying that "soil 

biology" can happen without soil is not substantiated by definition or data.

6. Other issues

The Task Force report included information about production in controlled indoor environments and 

electric vs. natural lighting. Some of the other international standards take up issues such as the use of 

energy and the sustainability of peat moss. At other times the issue of supplementing carbon dioxide in 

greenhouses through heating or adding an input have been brought up. We are not going to take up 

these topics until the others are worked out.

Discussion Questions

1. For container production of crop plants which of the suggestions made in the discussion above should 

 be recommended as standards? Why?

 For example, container size, amount of compost or soil in growing media, stipulation about liquid vs. 

 solid nutrition sources, and varying requirements for different crop types.

2. Do you have other suggestions about certified organic container production?

Motion to accept the discussion document on container-based growing.

Motion by: Zea Sonnabend 

Seconded by: Harold Austin

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

Glossary of terms 

Source in (Parentheses)

Aquaponics – A system in which plants are grown in waste water from aquatic organisms, which in turn 

purifies the water. (Task Force Report)

Aeroponics – A variation of hydroponics in which plant roots are suspended in air and misted with 

nutrient solution. (2010 NOSB Recommendation)

Bioponics – A contained and controlled growing system in which plants in growing media derive 

nutrients from natural animal, plant and mineral substances that are released by the biological activity 

of microorganisms and delivered in water. (Task Force Report with slight modification by CS)

Compost – The product of a managed process through which microorganisms break down plant and 

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animal materials, including allowed feedstock materials (either nonsynthetic substances not prohibited 

at § 205.602, or synthetics approved for use as plant or soil amendments), into more available forms 

suitable for application to the soil. Compost must be produced through a process that combines plant 

and animal materials with an initial C:N ratio of between 25:1 and 40:1 and processes it to a low final 

C:N ratio (in the range of 5:1 to 20:1). Producers using an in-vessel or static aerated pile system must 

maintain the composting materials at a temperature between 131 °F and 170 °F for 3 days. Producers 

using a windrow system must maintain the composting materials at a temperature between 131 °F and 

170 °F for 15 days, during which time, the materials must be turned a minimum of five times. (USDA 

organic rule)

Compost Tea – A water extract of compost produced to transfer microbial biomass, fine particulate 

organic matter, and soluble chemical components into an aqueous phase, intending to maintain or 

increase (it may be brewed) the living, beneficial microorganisms extracted from the compost. (Task 

Force Report)

Container – Any vessel and associated equipment used to house growing media and the complete root 

structure of terrestrial plants and to prevent the roots from contacting the soil or surface beneath the 

vessel, such as, but not limited to, pots, troughs, plastic bags, floor mats, etc. (Task Force Report)

Greenhouse – Permanent enclosed structure that allows for an actively controlled environment used to 

grow crops, annual seedlings or planting stock. (2010 NOSB Recommendation)

Hydroponics – The growing of normally terrestrial vascular plants in mineral nutrient solutions with or 

without an inert growing media to provide mechanical support. (Hybrid definition adopted by CS from 

Task Force report)

Growing media – Material which provides sufficient support for the plant root system and enables the 

plant to extract water and nutrients. Used interchangeably with the term "substrate". (Adopted by CS 

from Task Force and internet sources)

Microbial solution – Growing solution used in bioponic production which is commonly composed of 

organic substances and a diverse ecosystem of beneficial microorganisms in water. (Task Force Report)

Nutrient solution – Growing solution used in traditional hydroponic production which is commonly 

composed of immediately plant-available soluble synthetic mineral salts in water (Task Force Report)

Soil – The outermost layer of the earth comprised of minerals, water, air, organic matter, and living 

organisms, in which plants grow. (Modified from Task Force Report)

Soil Ecology – A term used to describe the incredible diversity of organisms that live in the soil and the 

complex interactions between them that contribute to plant nutrition and plant and soil health. They 

range in size from the tiniest one-celled bacteria, algae, fungi, and protozoa, to the more complex 

nematodes and microarthropods, to the visible earthworms, insects, small vertebrates, and plants. 

(Hybrid definition adopted by CS from Task Force report)

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National Organic Standards Board 

Policy Development Subcommittee Proposal

Policy and Procedures Manual Revision 

September 13, 2016

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 public comment at the April 2016 NOSB meeting 

several additional suggested changes to the PPM were raised that were not directly addressed by that 

revision. The PDS has reviewed these additional suggested changes and proposes the following changes as 

listed in the table below. Not all items raised by the public or the Board have been addressed by the 

Subcommittee. Outstanding items will be forwarded to the PDS for ongoing consideration. 

Summary Table of Changes

Section Change

III.D Role of the Administrative team is clarified. 

III.I Recordkeeping sections are clarified and include updated reference to relevant section of 

the general records scheduled 6.2 applicable to FACA committees as well as the GSA memo 

to CMO’s on FACA disclosures. 

IV.H Revised sections on petitions and proposals to allow the NOSB to remove National List 

items by adding a proposal to remove to the work agenda. Former process was via public 

petition only. 

VIII.C Clarified order of procedures of rules under which the NOSB operates. 

VIII.F Clarified election of officers to require majority voting. 

Appendix 2 Specified goal of publishing the next NOSB meeting docket as soon as possible after 

previous NOSB meeting to create an “open docket” for public input.

Attachments

Redlined version of the Policy and Procedure Manual comparing the draft September 13, 2016 to the April 

26, 2016 version

Proposal

The NOSB moves to adopt the September 13, 2016 draft version of the Policy and Procedures Manual.

Subcommittee Vote

The NOSB Policy Development Subcommittee approves the three sections of this proposal as stated above.

Motion to accept the Policy and Procedures Manual (PPM) as edited 

Motion by: Tom Chapman

Seconded by: Tracy Favre 

Additional discussion: none

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

157/279
 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

Draft September 13, 2016

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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.......................................................................................................................... 8

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.........................................................................................................................15

K. DECLARATION OF INTERESTS/CONFLICT OF INTEREST ....................................................................................15

IV. SUBCOMMITTEES..............................................................................................................................17

A. STANDING SUBCOMMITTEES .......................................................................................................................17

B. AD HOC SUBCOMMITTEES............................................................................................................................19

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 ...................................................................................................23

1. Steps in the material review process for a new petition: ..........................................................................23

2. Changes to annotations or classification of materials...............................................................................26

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3. Additional considerations concerning Technical Reviews .........................................................................27

4. Definitions............................................................................................................................................27

V. PRIORITIZATION OF PETITIONS............................................................................................................28

VI. WITHDRAWAL OF A PETITION BY A PETITIONER.....................................................................................28

VII. SUNSET REVIEW PROCESS ..................................................................................................................29

VIII. NOSB PROCEDURES...........................................................................................................................30

A. BOARD MEETINGS .......................................................................................................................................30

B. CONDUCTING BUSINESS...............................................................................................................................30

C. PARLIAMENTARY PROCEDURES....................................................................................................................31

D. NOSB DELIBERATIONS AND RECOMMENDATIONS .........................................................................................31

E. PUBLIC COMMENT.......................................................................................................................................32

F. ELECTION OF OFFICERS................................................................................................................................. 33

G. MISCELLANEOUS PROCEDURES ....................................................................................................................34

1. Invited Speakers ...................................................................................................................................34

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

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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 

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• Communicating, supporting and coordinating with the NOP staff 

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 

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(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: 

• 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. 

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(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 

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 

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members hold an election each fall at the public meeting to elect these three members.

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 

• 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 once or twice a month 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.

E. NOSB-NOP COLLABORATION 

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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: 

• 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 

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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 

addressed, background, including the current policy or situation, statutory/regulatory 

authority, legal context, and desired timeframe for receiving the recommendation. The 

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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:

• Ensuring that all FACA and OFPA requirements are implemented 

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• 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 26, Item 2 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 

conclusions, and the outcome of voting. If not included in the minutes, a voting summary 

will be published that contains votes by member. 

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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 

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business brought before the NOSB. 

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 

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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 

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

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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: 

• 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. 

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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

(etcetera).” 

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) 

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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.

 

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. 

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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 

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 

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• 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.

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 

Immediately after the election, on the final day of the NOSB meeting, the new 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. 

4. 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. 

5. Review of Subcommittee Files 

New Subcommittee Chairs should review all work agenda items and active files 

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involving Subcommittee work

 

6. 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. 

7. 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, 

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 

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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. 

• 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

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 

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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. 

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 H 2

in this PPM.(currently January 18, 2007 [72 FR 2167]).

1. 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 if a Technical Review (TR) is needed. 

3. Technical Report is completed and sent to the Subcommittee for review.

4. TR sufficiency is determined by SC, and the TR is posted on the NOSB website by the 

NOP. 

5. SC reviews substance, develops proposal, discusses proposal and votes, and submits for 

posting 45 days prior to public meeting.

6. The NOSB members analyze comments and votes on the proposal at the public meeting. 

7. 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 

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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

• 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: Determine whether a Third Party Technical Review is required 

During this phase, 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? 

• 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 

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 

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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 3: 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.

• 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 4: 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.

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Once the Technical Reports are deemed sufficient, the NOP will post on the NOP 

website.

Step 5: 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, and recommendations of a contracted panel of experts when utilized. 

• Subcommittee members will prepare a written review 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. 

• All proposals must be submitted to NOP for posting 45 days before the public 

meeting date. 

Step 6: 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. 

2. 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.

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• 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. 

3. Additional considerations concerning Technical Reviews

Basic principles that should be considered when consulting with a third party expert: 

• 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 makes a determination on 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

4. 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.

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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 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 

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(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 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 

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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.

o 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.

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. 

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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

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 

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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.

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 

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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.

• 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.

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 

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• 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 after each officer nomination and the Chair will verify the 

results. 

• The first nominee to receive a majority candidate receiving the greatest number 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 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 or may be given the opportunity to withdraw at their 

discretion.

• 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. 

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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. 

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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; 

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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. 

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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: 

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• 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

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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 

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 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

Draft Feb. 29, 2016

This is a comparison document between the currently posted version of 

the NOSB Policy and Procedures Manual (April 11, 2012) and the new 

Feb. 29, 2016 draft. Revisions are shown in strikeout for deletions, and 

with underline for additions or rearranging.

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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.......................................................................................................................... 8

F. NOSB WORK AGENDAS .................................................................................................................................. 9

G. DESIGNATED FEDERAL OFFICER ............................................................................................................................ 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 ....................................................................................................................... 15

K. DECLARATION OF INTERESTS/CONFLICT OF INTEREST .......................................................................................... 15

IV. SUBCOMMITTEES ..................................................................................................................................... 17

A. STANDING SUBCOMMITTEES ....................................................................................................................... 17

B. AD HOC SUBCOMMITTEES............................................................................................................................ 19

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 ................................................................................................... 23

1. Steps in the material review process for a new petition: ......................................................................... 23

2. Changes to annotations or classification of materials............................................................................. 26

3. Additional considerations concerning Technical Reviews ....................................................................... 27

4. Definitions ........................................................................................................................................... 27

V. PRIORITIZATION OF PETITIONS..................................................................................................................... 28

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VI. WITHDRAWAL OF A PETITION BY A PETITIONER............................................................................................ 28

VII. SUNSET REVIEW PROCESS............................................................................................................................ 29

VIII. NOSB PROCEDURES .................................................................................................................................. 30

A. BOARD MEETINGS ....................................................................................................................................... 30

B. CONDUCTING BUSINESS............................................................................................................................... 30

C. PARLIAMENTARY PROCEDURES.................................................................................................................... 31

D. NOSB DELIBERATIONS AND RECOMMENDATIONS ......................................................................................... 31

E. PUBLIC COMMENT....................................................................................................................................... 32

F. ELECTION OF OFFICERS................................................................................................................................. 33

G. MISCELLANEOUS PROCEDURES .................................................................................................................... 34

1. Invited Speakers................................................................................................................................... 34

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

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XI. 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 

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XII. 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.” 

XIII. 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 

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staggered and the USDA periodically requests nominations to fill upcoming vacancies. Selection 

criteria include the following: 

• 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 

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. 

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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:

8. the potential of such substances for detrimental chemical interactions with other 

materials used in organic farming systems; 

9. 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; 

10. the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance; 

11. the effect of the substance on human health; 

12. 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; 

13. the alternatives to using the substance in terms of practices or other available 

materials; and 

14. 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.

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 

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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 

• 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 once or twice a month on an as-needed basis, to be determined by the 

Administrative Team.

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 

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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: 

• 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.

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• 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: 

4. NOSB Subcommittees submit to the Executive Subcommittee draft work agenda items 

based on AMS-NOP requests, NOSB priorities, and requests from public comment. 

5. The NOP and Executive Subcommittee review the draft NOSB work agenda. The content and 

schedule will be reviewed on an ongoing, as needed basis. 

6. NOP confirms the final NOSB work agenda, and provides written confirmation. . 

Work agenda items should be prioritized accordingly:

5. Substance evaluations (e.g., 5-year sunset review, petitions) 

6. NOP requests to the NOSB 

7. NOSB requests to NOP

8. 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 

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 

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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:

• 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 

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• 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 handled in accordance with General Records Schedule 26, Item 

2 or other approved agency records disposition schedule. These records shall be available 

for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552. 

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, a complete and 

accurate description of matters discussed and conclusions , and the outcome of voting. 

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 

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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. 

4) 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. 

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. 

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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.

5) 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. 

6) Failure to participate 

The NOSB typically has a heavy work load and thus active participation by all 15 

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 

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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: 

• 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 

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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 DFOto 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: 

8. 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. 

9. 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). 

10. 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. 

11. 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. 

12. 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 

(etcetera).” 

13. 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 

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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. 

14. 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. 

XIV. 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.

 

Handling Subcommittee (HS) 

The Handling Subcommittee drafts proposals for consideration by the NOSB to provide 

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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 

Executive Committee.

C. SUBCOMMITTEE MEETINGS 

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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.

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. 

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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:

8. The new NOSB Chair takes Office 

Immediately after the election, on the final day of the NOSB meeting, the new Chair 

takes office. 

9. Appointment of Subcommittee Chairs 

The Board Chair appoints Subcommittee Chairs preferably chosen from members 

with at least one year of NOSB experience.

10. Appointment of Subcommittee Vice Chair

Vice Chairs shall be appointed by the incoming Subcommittee Chair, in conjunction 

with the Board Chair.

11. 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. 

12. Review of Subcommittee Files 

New Subcommittee Chairs should review all work agenda items and active files 

involving Subcommittee work

 

13. 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. 

14. Appointment of New NOSB Members: 

The Board Chair will appoint each new NOSB member to appropriate 

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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, 

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

4. 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. 

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• 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. 

• 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.

5. 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

6. 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: 

7. Introduction: A brief summary of the issue or statement of the problem. 

8. 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. 

9. Proposal: A concise explanation of the recommended action. 

10. 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.

11. Public Comment: A brief summary of the public comments

12. 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 

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recent Federal Register notice instructions (currently January 18, 2007 [72 FR 2167]).

8. Steps in the material review process for a new petition: 

2. 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.

9. Subcommittee (SC) determines if a Technical Review (TR) is needed. 

10. Technical Report is completed and sent to the Subcommittee for review.

11. TR sufficiency is determined by SC, and the TR is posted on the NOSB website by the 

NOP.

12. SC reviews substance, develops proposal, discusses proposal and votes, and submits for 

posting 45 days prior to public meeting.

13. The NOSB members analyze comments and votes on the proposal at the public meeting. 

14. 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

• 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

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Step 2: Determine whether a Third Party Technical Review is required 

During this phase, 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? 

• 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 

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 3: 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.

• Ensure that TRs/TAP reports are sufficient and complete when they are distributed to 

the Subcommittee 

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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 4: 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 5: 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, and recommendations of a contracted panel of experts when utilized. 

• Subcommittee members will prepare a written review 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. 

• All proposals must be submitted to NOP for posting 45 days before the public 

meeting date. 

Step 6: Action by Full NOSB 

During this phase the NOP will: 

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• 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. 

5. Changes to annotations 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 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. 

6. Additional considerations concerning Technical Reviews

Basic principles that should be considered when consulting with a third party expert: 

• 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 makes a determination on the completeness of the petition and 

whether a Technical Review is needed. 

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• 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

7. 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. 

XV. Prioritization of Petitions 

Petitions received and deemed eligible and sufficient by the NOP/NOSB will be 

prioritized as follows:

Priority 1: A petition 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 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 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 

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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. 

XVI. 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. 

XVII. 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 

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 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. 

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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.

o 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.

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XVIII. 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

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.

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 

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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.

• 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 

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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.

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:

4. Chair

5. Vice Chair

6. 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 after each officer nomination and the Chair will verify the 

results 

• The candidate receiving the greatest number of votes will be elected

• 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 or may be given the opportunity to withdraw at their 

discretion

• Votes will remain confidential, and ballots will be disposed of by the Chair or Secretary. 

G. MISCELLANEOUS PROCEDURES

 

3. Invited Speakers

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• 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. 

4. 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.

XIX. 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. 

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XX. APPENDICES 

A. Appendix 1: FOUNDATIONS 

4. NOSB PRINCIPLES OF ORGANIC PRODUCTION AND HANDLING 

(NOSB Recommendation Adopted October 17, 2001)

1.3Organic 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. 

1.4 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; 

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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. 

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5. 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? 

6. 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: 

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• 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

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, 

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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 Ppublish 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

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National Organic Standards Board

Policy Development Subcommittee Proposal

Sunset Review - Efficient Work Load Reorganization 

August 9, 2016

INTRODUCTION:

At present, the National Organic Standards Board (NOSB) conducts sunset reviews of materials according to 

the same schedule that the materials were added to the National List. Since the majority of materials on 

the National List were first included when the organic regulations were published in 2002, the number of 

materials reviewed each year by the NOSB is radically disproportionate. The peak of required reviews 

occurs in the 2/7 review cycle1 (2022/2027) with 187 material listings (estimated), and corresponds to the 

date that most materials were added on the National List with the promulgation of the final rule in 2002. In 

contrast the 4/9 cycle (2019/2024) which has only 1 material set for review. The sum of materials for all 

years other than the 2/7 cycle is 31 (estimated). Reviewing 196 materials in one year and 27 materials over 

4 years is an inefficient use of resources and board time.

BACKGROUND: 

The National List identifies synthetic substances that may be used in organic production and nonsynthetic 

(natural) substances that may not be used. It also includes non-organic substances that may be used in or 

on processed organic products.

As provided for by the “sunset provision” of the Organic Foods Production Act, (OFPA) “No exemption or 

prohibition contained in the National List shall be valid unless the National Organic Standards Board has 

reviewed such exemption or prohibition...within 5 years of such exemption or prohibition being adopted or 

reviewed and the Secretary has renewed such exemption or prohibition (7 U.S.C. 6517(e)).” 

The National Organic Standards Board (NOSB) reviews materials on the National List on a schedule that 

ensures each material is reviewed prior to the end of this five-year period. By giving each material its due

consideration, the NOSB can offer recommendations to the Secretary (via USDA National Organic Program) 

as to whether materials should be removed from the National List. The review of each material can be 

significant, as it involves research (including completion of technical reports by a third party, upon NOSB’s 

request), debate among the NOSB, public comment periods, and public meetings. Public comment includes 

considerable time and resources by a wide array of stakeholders, including thousands of pages of detailed 

written reports for every material, often prepared in a very short period of time. The NOP currently allows 

for approximately two years for each material to complete the sunset review cycle; i.e. materials that 

“sunset” in 2018 are being considered in 2016 by the NOSB. 

1 A Note of terminology used to talk about sunset review cycles. Sunset review cycles occur every five years 

in a predictable pattern. To facilitate brevity, in this document the review cycle will termed by the last year 

digits – so an item on the current 2018 sunset review would be part of the 3/8 sunset review cycle. 

Terminology used Current Sunset Cycle Next Sunset Review year

0/5 cycle 2020 (reviewed in 2018) 2025 (reviewed in 2023)

1/6 cycle 2021 (reviewed in 2019) 2026 (reviewed in 2024)

2/7 cycle 2022 (reviewed in 2020) 2027 (reviewed in 2025)

3/8 cycle 2018 (reviewed in 2016) 2023 (reviewed in 2021)

4/9 cycle 2019 (reviewed in 2017) 2024 (reviewed in 2022)

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The advantages of a more even distribution of this work include: 

• More balanced attention for individual materials, regardless of the date it was added to the 

National List

• Predictable and balanced materials workload for NOSB

• Reduced strain on NOP in supporting the NOSB’s reviews during peak years, including coordination 

and review of technical reports and rulemaking actions

• Greater efficiencies in time and staff resources at NOP

• More reasonable number of items for the public to comment on in the limited time provided under 

the regulations.

Advancing the review of materials is the only way to resolve the distribution problem. Without any change, 

the disproportionate number of materials that sunset in 2017 will again come up for review in 2022. Since 

the review workload is lighter in all other years of the five year cycle than 2017, the NOSB could achieve an 

even load most quickly by advancing review as soon as possible after the 2017 materials have completed 

the renewal process.

RELEVANT AREAS OF OFPA: 

No exemption or prohibition contained in the National List shall be valid unless the National Organic 

Standards Board has reviewed such exemption or prohibition...within 5 years of such exemption or 

prohibition being adopted or reviewed and the Secretary has renewed such exemption or prohibition (7 

U.S.C. 6517(e)).” 

DISCUSSION:

The following will be observed to complete early review of 2/7 sunset items: 

3/8 cycle excluded – Items will not be moved from the 2/7 to the 3/8 due to timing - items would need to 

be included in the 2016 review occurring concurrent to this discussion document. Additionally, items 

should be “reviewed” after the program has “renewed” items on the national list. This renewal step will 

take place no later than 3/17/2017 when the first 2017 material reached 5 years from its last renewal. 

Since reviews occur 2 years prior to the sunset review date, 2018 materials need to be reviewed prior to 

3/17/2017. 

Only materials on the 2/7 cycle are subject to early review- Only items from the 2/7 cycle are being 

evaluated for an early review. Items on other cycles will remain where they are even if an earlier review 

would led to a more efficient review. Since materials may be added or removed from the list in any year, a 

perfectly even work load in unrealistic. 

Materials voted for removal during 2016 and 2017 Sunset Review Excluded. Items voted for removal under 

the 2016 and 2017 sunset review are excluded from this process and accounting of materials since these 

materials should be removed from the National List prior to implementation of these proposals. 

Early Review – A list of the materials to be reviewed early are listed below as part of attachment A. 2/7 

cycle materials will be added to the work agenda in spring of each year prior to the review year by request 

of the PDS. All other materials will remain on their current timelines. The materials will then be referred to 

the respective subcommittees. Work will cease for any material whose sunset date is modified from the 

2/7 sunset cycle due to rulemaking, until such rulemaking, the subcommittees shall continue to work 

against the earlier review date. An early review of materials will be based on current information and 

known alternatives that are commercially available in the year they will be reviewed, and not on 

alternatives that may be available in 2022. If not mentioned below, sunset review shall occur along with 

the normal sunset materials for that cycle. 

Material Removals – Farmers, livestock operations and handling operations need to operate under a 

predictable business environment. These businesses are planning operations and researching new 

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alternative materials on a 5-year cycle. Items reviewed early under the reorganization plan should be 

allowed to sunset on their original timeline in 2022. To do this, the NOSB will modify their sunset review 

documents to specify a 2022 removal and work in collaboration with the program to delay rulemaking until 

2022. 

Workload – Workload should be roughly evenly distributed amongst the 4 years. Materials should be split 

by subcommittee to even the workload of each subcommittee. Since materials may be added or removed 

from the list in any year, a perfectly even work load in unrealistic. 

Impartial and Efficient - The process of reorganization should be as impartial and non-political as possible 

while also being efficient. Similar items are grouped together (i.e. chlorine materials) as best as can be 

keeping in mind the restrictions above, and then sequentially distributed into each of the 4 years. Any 

grouping will be put in the year where the first item in the group is numbered. The PDS believes this 

proposal achieves efficiency by grouping like items for review, allowing for TRs to be coordinated across 

subcommittees and for reviews to take into account all facets of allowed usages across the organic 

industry. At the same time, the reorganization is impartial and blind to bias by using sequential reordering. 

Vote in Subcommittee

Motion to accept this proposal on Sunset review efficient work load reorganization

Motion by: Tom Chapman

Seconded by: Jean Richardson

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

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Attachment A

NL Section Substance Current 

Sunset Date

Sub 

Committee

Next Projected 

Sunset Year

Proposed Sunset 

Review Year

205.601(a) Calcium 

hypochlorite 6/27/2017 CS 2022 2019

205.601(a) Chlorine dioxide 6/27/2017 CS 2022 2019

205.601(a) Ethanol 6/27/2017 CS 2022 2020

205.601(a) Hydrogen 

peroxide 6/27/2017 CS 2022 2021

205.601(a) Isopropanol 6/27/2017 CS 2022 2020

205.601(a) Sodium 

hypochlorite 6/27/2017 CS 2022 2019

205.601(b) Herbicides, 

soap-based 6/27/2017 CS 2022 2019

205.601(b)

Newspaper or 

other recycled 

paper

6/27/2017 CS 2022 2020

205.601(b)

Plastic mulch 

and covers 

(petroleumbased other 

than 

polyvinylchlorid

e (PVC))

6/27/2017 CS 2022 2020

205.601(c)

Newspaper or 

other recycled 

paper

6/27/2017 CS 2022 2020

205.601(d) Soaps, 

ammonium 6/27/2017 CS 2022 2021

205.601(e) Boric acid 6/27/2017 CS 2022 2019

205.601(e) Elemental sulfur 6/27/2017 CS 2022 2020

205.601(e) Lime sulfur 6/27/2017 CS 2022 2020

205.601(e) Oils, 

horticultural 6/27/2017 CS 2022 2021

205.601(e) Sticky 

traps/barriers 6/27/2017 CS 2022 2019

205.601(e)

Sucrose 

octanoate 

esters

6/27/2017 CS 2022 2020

205.601(f) Pheromones 6/27/2017 CS 2022 2021

205.601(i) Copper sulfate 6/27/2017 CS 2022 2019

205.601(i) Coppers, fixed 6/27/2017 CS 2022 2019

205.601(i) Elemental sulfur 6/27/2017 CS 2022 2020

205.601(i) Hydrated lime 6/27/2017 CS 2022 2020

205.601(i) Hydrogen 

peroxide 6/27/2017 CS 2022 2021

240/279
205.601(i) Lime sulfur 6/27/2017 CS 2022 2020

205.601(i) Oils, 

horticultural 6/27/2017 CS 2022 2021

205.601(i) Potassium 

bicarbonate 6/27/2017 CS 2022 2021

205.601(j) Elemental sulfur 6/27/2017 CS 2022 2020

205.601(j) Humic acids 6/27/2017 CS 2022 2019

205.601(j) Liquid fish 

products 6/27/2017 CS 2022 2020

205.601(j) Magnesium 

sulfate 6/27/2017 CS 2022 2021

205.601(j) Soluble boron 

products 6/27/2017 CS 2022 2019

205.601(j)

Sulfates, 

carbonates, 

oxides, or 

silicates of zinc, 

copper, iron, 

manganese, 

molybdenum, 

selenium, and 

cobalt

6/27/2017 CS 2022 2019

205.601(j) Vitamin B1 6/27/2017 CS 2022 2019

205.601(j) Vitamin C 6/27/2017 CS 2022 2019

205.601(j) Vitamin E 6/27/2017 CS 2022 2019

205.601(k) Ethylene 6/27/2017 CS 2022 2020

205.601(l) Lignin sulfonate 6/27/2017 CS 2022 2021

205.601(o) Microcrystalline 

cheesewax 3/15/2017 CS 2022 2020

205.602(a) Ash from 

manure burning 6/27/2017 CS 2022 2021

205.602(d) Lead salts 6/27/2017 CS 2022 2019

205.602(e) Potassium 

chloride 6/27/2017 CS 2022 2020

205.602(f) Sodium 

fluoaluminate 6/27/2017 CS 2022 2021

205.602(i)

Tobacco dust 

(nicotine 

sulfate)

6/27/2017 CS 2022 2019

205.603(a) Aspirin 6/27/2017 LS 2022 2020

205.603(a) Atropine 6/27/2017 LS 2022 2021

205.603(a) Calcium 

hypochlorite 6/27/2017 LS 2022 2019

205.603(a) Chlorhexidine 6/27/2017 LS 2022 2019

205.603(a) Chlorine dioxide 6/27/2017 LS 2022 2019

241/279
205.603(a) Electrolytes 6/27/2017 LS 2022 2020

205.603(a) Ethanol 6/27/2017 LS 2022 2020

205.603(a) Fenbendazole 5/16/2017 LS 2022 2021

205.603(a) Glucose 6/27/2017 LS 2022 2019

205.603(a) Glycerine 6/27/2017 LS 2022 2020

205.603(a) Hydrogen 

peroxide 6/27/2017 LS 2022 2021

205.603(a) Iodine 6/27/2017 LS 2022 2021

205.603(a) Isopropanol 6/27/2017 LS 2022 2020

205.603(a) Ivermectin 6/27/2017 LS 2022 2021

205.603(a) Magnesium 

sulfate 6/27/2017 LS 2022 2021

205.603(a) Moxidectin 5/16/2017 LS 2022 2021

205.603(a) Oxytocin 6/27/2017 LS 2022 2019

205.603(a) Peracetic acid 6/27/2017 LS 2022 2021

205.603(a) Phosphoric acid 6/27/2017 LS 2022 2020

205.603(a) Sodium 

hypochlorite 6/27/2017 LS 2022 2019

205.603(a) Tolazoline 6/27/2017 LS 2022 2019

205.603(a) Vaccines 6/27/2017 LS 2022 2020

205.603(a) Xylazine 6/27/2017 LS 2022 2021

205.603(b) Copper sulfate 6/27/2017 LS 2022 2019

205.603(b) Hydrated lime 6/27/2017 LS 2022 2020

205.603(b) Iodine 6/27/2017 LS 2022 2021

205.603(b) Lidocaine 6/27/2017 LS 2022 2019

205.603(b) Mineral oil 6/27/2017 LS 2022 2020

205.603(b) Procaine 6/27/2017 LS 2022 2019

205.603(b)

Sucrose 

octanoate 

esters

6/27/2017 LS 2022 2020

205.603(d) Methionine 10/2/2017 LS 2022 2021

205.603(d) Trace minerals 6/27/2017 LS 2022 2021

205.603(d) Vitamins 6/27/2017 LS 2022 2021

205.605(a) Alginic acid 6/27/2017 HS 2022 2021

205.605(a) Attapulgite 8/3/2017 HS 2022 2019

205.605(a) Bentonite 6/27/2017 HS 2022 2019

205.605(a) Calcium 

carbonate 6/27/2017 HS 2022 2020

205.605(a) Calcium chloride 6/27/2017 HS 2022 2021

205.605(a) Citric acid 6/27/2017 HS 2022 2021

205.605(a) Dairy cultures 6/27/2017 HS 2022 2021

205.605(a) Diatomaceous 

earth 6/27/2017 HS 2022 2019

205.605(a) Enzymes 6/27/2017 HS 2022 2021

205.605(a) Flavors 6/27/2017 HS 2022 2020

242/279
205.605(a) Lactic acid 6/27/2017 HS 2022 2021

205.605(a) Magnesium 

sulfate 6/27/2017 HS 2022 2021

205.605(a) Nitrogen 6/27/2017 HS 2022 2019

205.605(a) Oxygen 6/27/2017 HS 2022 2020

205.605(a) Perlite 6/27/2017 HS 2022 2021

205.605(a) Potassium 

chloride 6/27/2017 HS 2022 2020

205.605(a) Potassium 

iodide 6/27/2017 HS 2022 2021

205.605(a) Sodium 

carbonate 6/27/2017 HS 2022 2019

205.605(a) Yeast 10/21/2017 HS 2022 2021

205.605(b) Acidified 

sodium chlorite 3/15/2017 HS 2022 2019

205.605(b) Alginates 6/27/2017 HS 2022 2020

205.605(b) Ascorbic acid 6/27/2017 HS 2022 2021

205.605(b) Calcium citrate 6/27/2017 HS 2022 2021

205.605(b) Calcium 

hydroxide 6/27/2017 HS 2022 2020

205.605(b) Calcium 

hypochlorite 6/27/2017 HS 2022 2019

205.605(b) Carbon dioxide 6/27/2017 HS 2022 2019

205.605(b) Chlorine dioxide 6/27/2017 HS 2022 2019

205.605(b) Diglycerides 6/27/2017 HS 2022 2020

205.605(b) Ethylene 6/27/2017 HS 2022 2020

205.605(b) Ferrous sulfate 6/27/2017 HS 2022 2021

205.605(b) Hydrogen 

peroxide 6/27/2017 HS 2022 2021

205.605(b) Magnesium 

chloride 6/27/2017 HS 2022 2019

205.605(b) Magnesium 

stearate 6/27/2017 HS 2022 2020

205.605(b) Monoglycerides 6/27/2017 HS 2022 2020

205.605(b)

Nutrient 

vitamins and 

minerals

10/21/2017 HS 2022 2021

205.605(b) Phosphoric acid 6/27/2017 HS 2022 2020

205.605(b) Potassium acid 

tartrate 6/27/2017 HS 2022 2019

205.605(b) Potassium 

carbonate 6/27/2017 HS 2022 2020

205.605(b) Potassium 

citrate 6/27/2017 HS 2022 2021

205.605(b) Potassium 

phosphate 6/27/2017 HS 2022 2021

243/279
205.605(b) Sodium citrate 6/27/2017 HS 2022 2021

205.605(b) Sodium 

hypochlorite 6/27/2017 HS 2022 2019

205.605(b) Sodium 

phosphates 6/27/2017 HS 2022 2019

205.605(b) Sulfur dioxide 6/27/2017 HS 2022 2020

205.605(b) Tocopherols 6/27/2017 HS 2022 2021

205.605(b) Xanthan gum 6/27/2017 HS 2022 2020

205.606 Arabic gum 6/27/2017 HS 2022 2020

205.606 Carob bean gum 6/27/2017 HS 2022 2020

205.606 Casings 6/27/2017 HS 2022 2019

205.606 Celery powder 6/27/2017 HS 2022 2021

205.606 Fish oil 6/27/2017 HS 2022 2021

205.606 Fructooligosacc

harides 6/27/2017 HS 2022 2020

205.606 Gelatin 6/27/2017 HS 2022 2021

205.606 Guar gum 6/27/2017 HS 2022 2020

205.606 Konjac flour 6/27/2017 HS 2022 2019

205.606 Lecithin

—de-

oiled 3/15/2017 HS 2022 2020

205.606 Locust bean 

gum 6/27/2017 HS 2022 2020

205.606 Orange pulp, 

dried 3/15/2017 HS 2022 2021

205.606 

Pectin (non-

amidated forms 

only)

6/27/2017 HS 2022 2019

205.606 Seaweed, Pacific 

kombu 3/15/2017 HS 2022 2021

205.606 

Wakame 

seaweed 

(Undaria 

pinnatifida)

6/27/2017 HS 2022 2021

244/279
National Organic Standards Board (NOSB)

Livestock Subcommittee

Proposal to remove ivermectin (CAS # 70288-86-7) from the National List

July 19, 2016

I SUMMARY: 

This proposal to remove ivermectin from §205.603 of the National List of Allowed and 

Prohibited Substances is made pursuant to the Organic Foods Production Act (OFPA), Section 

6518, in accordance with NOP 3011 effective March 11, 2016, and in response to a petition to 

remove ivermectin submitted to NOP on June 26, 2016. 

The NOSB finds that new information indicates that ivermectin should be removed from the 

National List, pursuant to Section 6518(m) of the OFPA, with particular reference to Criteria 2, 

5, 6, and 7 at Section 6518(m) as cited below:

 

(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; 

(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) Its compatibility with a system of sustainable agriculture.

II BACKGROUND: 

The USDA standards prohibit the use of parasiticides in slaughter stock.

The use of synthetic parasiticides in organic production is strictly confined to emergencies. 

Synthetic parasiticides cannot be used routinely, but sick animals must be treated. Typically 

farmers bring clean animals into their herds or flocks, select breeds which have high resistance 

to parasites, and manage their land, especially pastures, in a manner which reduces the 

likelihood of parasite infection. If an increased parasite load is noted in fecal egg counts, 

farmers have a broad array of alternative treatments available. But when all else fails and 

animals are not doing well, the farmer, working with the veterinarian, may need to use one of 

the synthetic parasiticides on the National List.

At the present time, there are three (3) substances on the National List which are approved for 

use as parasiticides for organic livestock: Ivermectin, moxidectin and fenbenzadole. All three of 

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these materials were recently reviewed as part of the regular five-year Sunset process. All three 

materials have annotations and other language limiting usage. 

In 2015 a comprehensive technical evaluation report (TR) on parasiticides was requested by the 

NOSB as part of its regular five year review of materials. A research bibliography is included in 

the technical report dated June 3, 2015. This research information is comprehensive in nature 

and reviews all aspects of use of ivermectin and comparisons with alternative herbal and 

synthetic parasiticides as well as management techniques on farms and ranches which can be 

used to reduce or eliminate use of parasiticides.

During 2015 the NOSB received public comment on ivermectin as part of the five year review 

for materials scheduled to Sunset in 2017. New information was provided which indicated that 

ivermectin was not always effective, that both moxidectin and fenbenzadole were also 

available for use, and that dung beetles, a critical component of good pasture management, are 

negatively impacted by use of ivermectin. 

With strong stakeholder support from all sectors the Subcommittee recommended removing 

ivermectin from the National List by a vote of 5 yes, 1 no and 2 absences. However, during the 

second posting of this material, public comment from a sector of producers, notably in western 

states, indicated that ivermectin was their preferred parasiticide, in part because fenbenzadole 

requires veterinarian prescription. Therefore the final NOSB vote at the October 2015 NOSB 

Meeting was to reluctantly continue to list ivermectin, but to immediately review all the 

parasiticides as a group. This additional review resulted in a Recommendation to make some 

changes to the parasiticide annotations as follows:

* That parasiticides continue to be prohibited in slaughter stock.

* That the milk withholding period after treatment with fenbenzadole or moxidectin be changed 

from 90 days to 2 days for dairy cows, and 36 days for goats and sheep. 

* That the listing for ivermectin remains as presently listed, with a 90 day withdrawal period. 

* That moxidectin be allowed for both internal and external use.

* 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 fenbenzadole be allowed without written order of a veterinarian. 

This parasiticide recommendation of April 27 2016 passed unanimously, 15:0. 

At that meeting the NOSB was again urged by a broad sector of stakeholders to petition to 

Remove ivermectin from the National List, based on the expectation that the April 27, 2016 

Recommendation on parasiticides is approved by the NOP and is successful in the rulemaking 

process.

Reference is also made to the following: 

Technical Report: 1999 Technical Advisory Panel Report (TAP)(fenbendazole, ivermectin); 2015 

Technical Evaluation Report on parasiticides; fenbenzadole, ivermectin, moxidectin. 

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Past NOSB Actions: 10/1999 NOSB minutes and vote; 11/2005 sunset recommendation;

10/2010 sunset recommendation; 10/2015 sunset recommendation.

4/27/16 Parasiticide Recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 

Sunset Date: 06/27/17

III RELEVANT AREAS OF THE RULE:

Section 205.603(a) – with language as recommended to NOP on April 27, 2016 

As disinfectants, sanitizer, and medical treatments as applicable 

(18) 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. Allowed in fiber bearing animals, when used a minimum of 90 days prior to harvest 

of fleece or wool that is to be sold, labeled or represented as organic. 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 approved for in subpart D of this part for: 2 days following 

treatment of cattle; 36 days following treatment of goats and sheep.

(ii) Ivermectin (CAS #70288-86-7)—milk or milk products from a treated animal cannot 

be labeled as approved for in subpart D of this part for 90 days following treatment.

(iii) Moxidectin (CAS #113507-06-5)—milk or milk products from a treated animal 

cannot be labeled as approved for in subpart D of this part for: 2 days following 

treatment of cattle; 36 days following treatment of goats and sheep.

Section 205.238 – with language as recommended to NOP on April 27, 2016 

The USDA organic regulations at 7 CFR part 205 provide guidance on livestock production 

practices to prevent the need for the use of parasiticides and regulate the use of parasiticides in 

organic livestock production: 

§205.238 Livestock health care practice standard.

(a) The producer must establish and maintain preventive livestock health care practices, 

including: 

(1) Selection of species and types of livestock with regard to suitability for site-specific 

conditions and resistance to prevalent diseases and parasites; 

(2) Provision of a feed ration sufficient to meet nutritional requirements, including 

vitamins, minerals, protein and/or amino acids, fatty acids, energy sources, and fiber 

(ruminants); 

(3) Establishment of appropriate housing, pasture conditions, and sanitation practices to 

minimize the occurrence and spread of diseases and parasites; 

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(b) When preventive practices and veterinary biologics are inadequate to prevent sickness, 

a producer may administer synthetic medications: Provided, that, such medications are 

allowed under §205.603. Parasiticides allowed under §205.603 may be used on: 

(1) Breeder stock, when used prior to the last third of gestation but not during lactation 

for progeny that are to be sold, labeled, or represented as organically produced. 

(2) Dairy animals, as allowed under §205.603. 

(3) Fiber bearing animals, as allowed under §205.603 

IV DISCUSSION: 

Parasiticides fall into five anthelmintic drug classes differentiated by their chemical structures. 

Moxidectin and ivermectin are both in one class of parasiticides, and fenbendazole is in a 

separate class, relative to their modes of action. Some commenters suggested that it may be 

beneficial to keep one parasiticide from each class on the National List to allow rotation of 

parasiticides, prevent the development of resistance, and have alternatives in cases where 

resistance develops. Also, different synthetic parasiticides allow different modes of use (i.e., 

oral administration, subcutaneous, and pour-on). Fenbendazole is restricted to use by oral 

administration only, whereas ivermectin and moxidectin are both approved for topical, 

subcutaneous and oral administration.

Ivermectin is approved for use in swine, sheep, cattle, goats, bison, deer and reindeer. 

Ivermectin is not approved for use in dairy animals, and no milk withdrawal time has been 

established for ivermectin.

1,2

Moxidectin is approved for use in cattle and sheep.

Fenbendazole is approved by FDA for use in cattle, swine, sheep, turkeys, goats, and deer.

In October 1999, the NOSB voted on three parasiticides for inclusion on the National List. Only 

ivermectin had sufficient votes be added to the List. The votes were: ivermectin 8-3-0, 

fenbendazole 5-6-0, and levamisole 0-11-0. 

In April 2004, the NOSB voted to add moxidectin to the National List by a vote of 11-1-1-1. The 

annotation “for control of internal parasites only” was included for moxidectin for the given 

reason that, “There is much less chance of any kind of contamination if it is used for internal 

parasites versus external.” According to the meeting notes, “It was the committee’s opinion, 

that (moxidectin) failed on Criteria 1, and that was the reason for the proposed annotation 

because of concern about the half–life of the material and impact on soil organisms.” However, 

the Board noted then that moxidectin “is also less problematic” than ivermectin. Further, it 

should be noted that just before the NOSB vote on moxidectin, a board member corrected an 

error that had been part of the discussion leading to the annotation: it was brought up that the 

1http://www.accessdata.fda.gov/scripts/animaldrugsatfda/details.cfm?dn=128-409 2 http://www.accessdata.fda.gov/scripts/animaldrugsatfda/

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2003 TAP review indicated the half-life of moxidectin in soil is two months, not six months as 

reported in the evaluation criteria document (which had led to support for the annotation). 

Although the NOSB approved the addition of moxidectin to the National List in 2004, the US

Department of Agriculture Secretary did not initially accept NOSB’s recommendation because 

moxidectin was labeled as a macrolide antibiotic. However, subsequent clarification found that 

moxidectin belongs to the polyene class of macrolides, “which unlike their erythromycin 

counterparts do not possess antibiotic properties” (2015 TR lines 100 – 111). Moxidectin was 

then added to the National List. 

In May 2008, fenbendazole was approved by the NOSB for addition to the National List by a 

vote of 14-0. The stated intention of the Livestock Committee at that time was that when 

fenbendazole was added to the List, ivermectin (and possibly moxidectin) should come off the 

List (meeting notes, page 207).

Ivermectin is considered to be the most harmful to soil life of the three parasiticides listed. The 

2015 TR indicates that the half-life for degradation of ivermectin is 127 days in soil. However, 

other sources indicate that the half-life of can be quite variable, depending on temperature and 

soil conditions. For example, the half-life of ivermectin in a soil/feces mixture was found to be 

91 to 217 days during winter weather conditions and 7 to 14 days during the summer period.3

The 2015 TR includes the following: “Fenbendazole does not appear to hinder rapid 

disappearance and mineralization of cattle dung pats in pastures and does not appear to affect 

the role that earthworms play in this process. Excreted ivermectin does delay the disappearance 

of dung pats, but does not affect earthworm populations or health. The delay in ivermectin 

treated soils may be the result of its toxicity to insects” (2015 TR lines 580 – 583). 

Ivermectin is more toxic to dung-dwelling insects than moxidectin: “The macrocyclic lactones 

(the class of parasiticides to which ivermectin and moxidectin belong) can be ranked in 

decreasing order of toxicity to dung-dwelling insects as abamectin>doramectin ≥ ivermectin > 

eprinomectin>>moxidectin” (TR 2015 Table 7). 

Although ivermectin is not labeled for use in dairy animals of breeding age, it may be used 

under veterinary order under provisions of AMDUCA (TR line 321). 

In its initial request for public comment, the Livestock Subcommittee asked the public: “Are the 

three parasiticides (ivermectin, moxidectin and fenbendazole) different enough in their modes of 

action that they should all remain on the National List? If not, which one(s) would you 

recommend be removed from the List, and why?”

3 Fate of Pharmaceuticals in the Environment and in Water Treatment Systems. 2008. Diana S. Aga ed., p. 128. CRC Press.

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In the public response the most common comment received was that ivermectin should be 

removed from the National List, primarily because of its toxic effects on dung beetle larvae.

Recent research indicates that ivermectin has a negative impact on the agro-ecosystem in a 

number of ways, but especially on its impact on dung beetles which are critical for healthy 

pastures.

Ivermectin is rapidly adsorbed to soil and sediment. Up to 98% of the administered dose of 

ivermectin may be excreted as non-metabolized drug in feces (Horvat et al., 2012). Ivermectin 

does not appreciably leach from soil sediment (Krogh et al., 2008). Radio-chromatographic 

studies have shown the ivermectin half-life for degradation to be 127 days in soil and less than 

6 hours in water (Prasse et al., 2009). The environmental burden on fields manured with feces 

from ivermectin treated animals ranges from 0.001 to 0.09 parts per billion (ppb) depending on 

animal species (Halley et al., 1989) (TR 2015, 568-573)

Ivermectin has very little solubility in water. The only route for entry into the environment is 

through animal excretion. Ivermectin has limited mobility in soil because it is lipophilic and 

tightly binds to soil particles. The half-life for degradation of ivermectin in soil can be as long 

240 days in natural soil depending on the soil type. Degradation in water is much faster with a 

half-life as short as 2.9 days. Ivermectin is hydrolytically unstable at pH 6.3. Predicted 

environmental concentrations based on the introduction of manure to field is relatively low and 

on the order of 100 parts per billion (ppb). 

Ivermectin is toxic to fish at concentrations between 3 and 17 ppb. 

Generally, since its introduction, no risks from appropriate use of ivermectin have been 

established for the environment or for human health. However, it has been consistently shown 

that ivermectin is unacceptably toxic for larval forms of arthropod insects (dung organisms) and

daphnids (Liebig et al., 2010; Oh et al., 2006). (TR 2015, 665-574)

There are many natural alternative parasiticides being used in organic livestock production 

today. Natural parasiticides include homeopathic remedies, diatomaceous earth and many 

herbs with anthelminthic properties. Table 10 of the 2015 TR lists over 50 botanical and 

alternative de-wormers. The efficacy of most of these natural alternatives is not well 

documented, and more research is needed. However, there does seem to be a lot of potential 

for the development of effective natural parasite control systems in the future.

Ivermectin is no longer necessary as there are two synthetic parasiticides, fenbenzadole and 

moxidectin which can be used in emergencies when preventive management practices have 

failed to control parasite load.

Further, the negative impacts of ivermectin on dung beetles in pastures and on rangelands is 

not compatible with a system of sustainable agriculture.

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Grazing management and the use of safe pastures for calves and sheep after weaning is an 

important component of helminth control in organic farming. It is important to have (1) 

preventive grazing management such as delayed turn-out, change of pastures between 

seasons, (2) diluting grazing management: mixed or alternate grazing with other host species, 

(3) evasive grazing management like changing the pasture within the season, and (4) 

supplementary feeding in the spring. 

Pasture management which includes grazing management using both goats and cattle has been 

found effective.

Organic farmers have found that there is a biological interdependence between animals and 

plants with the use of a “mixed farming” approach to grazing where (1) animals succeeded one 

another on the field to avoid species specific transfer of disease, i.e. dairy cattle, then sheep 

and goats, then beef cattle; (2) only composted animal wastes for fertilizer were used to avoid 

transfer of known disease agents to the soil and back to their livestock and (3) overcrowding 

and over grazing were avoided to prevent contact with potentially parasitic worms in various 

stages of development naturally following bacteria and fungus into specific plants and 

decomposing material (Sykes, 1949; Ingham, 1999). (TR 2015 932-938)

Organic farms tend to have a higher diversity of nematodes, since animals are not normally 

treated with anthelmintic drugs. Helminth diversity has been related to a lower intensity of 

infection in extensive goat breeding and in meat cattle (Caberet et al., 2002). (TR 2015, 924-

931)

Identifying and treating animals that are severely affected by parasites while leaving healthy 

animals that are coping with the disease untreated and maintaining a reservoir of susceptible 

parasites has also been effective for reducing the use of parasiticides and suppressing the 

development of anthelmintic resistance. This is called the FAMACHA system. It provides for a 

method of identifying diseased sheep using the color of their conjunctiva from deep red in 

healthy sheep to white in sick sheep as a guide (van Wyk and Bath, 2002). (TR 2015 lines 905-

913)

Many holistic products are available and effective for worming. Anthelmintic resistance is in 

part the result of improper use, e.g., the consequence of under dosing, mass therapy and the 

use of the same class of anthelmintics for prolonged periods of time (Villalba et al., 2014). 

Resistance to synthetic parasiticides is not a problem, if synthetic parasiticides are not used. 

Livestock production based on grazing and browsing systems is directly related to the use of 

plant resources (Alonzo-Diaz, 2014). With proper pasture management, a good diet with plenty 

of forage for livestock and knowledgeable coaches to provide appropriate strategies for 

husbandry and treatment healthy animals can be sustainably raised without synthetic

parasiticides (Brunetti and Karreman, 2006). (TR 939-946).

In Summary: 

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When evaluating ivermectin with reference to the OFPA Criteria at 6518(m), this material 

clearly demonstrates:

• That it is toxic in the environment – Criteria 2; 

• That it has a negative impact on dung beetles which are a critical component of good 

pasture management (pasture management is a requirement of organic farming) – 

Criteria 5; 

• That there are two alternative synthetic parasiticides which can be used as alternative 

medications during an emergency; that high quality pasture and range management 

grazing techniques can reduce the need to use any parasiticide; and that there are many 

alternative herbal remedies – Criteria 6;

• That use of ivermectin is incompatible with a system of sustainable agriculture – 

Criteria 7. 

V RECOMMENDATION - MOTION TO REMOVE: 

That ivermectin (CAS # 70288-86-7) be removed from the National List §205.603.

Vote in Subcommittee: 

Motion by: Jean Richardson

Seconded by: Harriet Behar

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0

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National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Aluminum Sulfate

June 21, 2016

Summary of Petition: 

In August 2013 the NOP received a petition to add Aluminum Sulfate to the National List of synthetic 

substances allowed for use in organic livestock production 7 CFR 205.603 as a poultry litter treatment. 

Summary of Review:

Manufacture and Uses of the Substance:

The intended and current use of aluminum sulfate is to be used as a poultry and livestock bedding 

amendment. Aluminum sulfate has been used in poultry, turkeys and livestock production for decades 

to safely and effectively protect animals and caretakers from volatilized ammonia that is generated from 

poultry and livestock manure, which accumulates in poultry and livestock bedding. For the sake of 

clarification, the term litter will be used synonymously with bedding and mixtures of used bedding and 

manure. Volatilized ammonia that occurs from the natural decomposition process in litter is the result of 

bacterial enzyme hydrolysis of uric acid to urea which is further hydrolyzed to ammonia (NH3). 

Ammonia has been shown to be detrimental to animal health, livability, well-being and overall live 

performance. Aluminum sulfate reacts with ammonia by donating acid ions, converting ammonia (NH3) 

to ammonium (NH4+), a highly reactive ion that bonds with nitrates, phosphates and sulfates forming 

stable non-volatile ammonium salts that are retained in the litter, which improve the litter’s nutrient 

value as a natural fertilizer. In addition to litter treatment in the poultry house, aluminum sulfate is 

being petitioned for use in organic crop production as a poultry litter additive. Litter treated with 

aluminum sulfate differs from non-treated litter, as it contains more total nitrogen and less soluble 

phosphorous, which increases the nitrogen fertilizer value and reduces phosphorous pollution of surface 

waters (Moore and Watkins 2012).

By retaining nitrogen in the litter through the conversion of NH3 to NH4+, and by binding soluble 

phosphorus, the fertilizer nutrient value of alum treated litter is improved. When land applied, litter that 

has been treated with alum contains bound soluble phosphorus that is utilized by plants on an as need 

basis. Plants have the ability to secrete acid from their roots to break the aluminum phosphate bonds 

re-solubilize phosphorus, making the essential nutrient available to plants. Aluminum sulfate in water 

treatment is classified as a flocculent and its function is to precipitate silica, minerals and organic 

material out of suspension. It is incorporated as one of the initial steps in municipal water purification. 

Aluminum sulfate based products have also been used for decades in municipal water treatment and 

lake restorations in the US and Canada. Over 50% of the municipal water in the US is treated with 

Chemtrade aluminum sulfate, the sponsor for this petition and aluminum sulfate is the most widely used 

water clarification chemical in the world. 

Dry aluminum sulfate is applied using drop spreaders, and centrifugal (slinger) spreaders, varying in size 

and complexity depending on application demand. Liquid aluminum sulfate is applied using a vehicle 

designed with a storage tanks, a pump and a PVC spray wand equipped with stainless steel nozzles. 

Typical dry product application rates range from 50 to 200 lbs/1000 ft2. Typical liquid product 

application rates range from 20 to 55 gal/1000 ft2. Dry aluminum sulfate is either applied by the poultry 

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farmer or by custom applicators. Liquid aluminum sulfate and acidified aluminum sulfate products are 

applied by custom applicators. 

The manufacturing process for all the forms of aluminum sulfate included in the petition involves 

reacting liquid sulfuric acid with either bauxite ore containing aluminum hydroxide (Al(OH)3) and 

hydrated aluminum (Al2O3∙3H2O), or synthetic hydrated aluminum previously refined from bauxite. 

Bauxite ore is the main source of aluminum for the world and contains various aluminum minerals and 

two iron minerals (Amethyst Galleries 2014). The process creates hydrated aluminum sulfate per the 

following reactions: 

From bauxite: 3 H2SO4 + 2 Al(OH)3 + 12 H2O → Al2(SO4)3 • 18 H2O 52 

From hydrated aluminum: 3 H2SO4 +Al2O3∙3H2O + 12 H2O → Al2(SO4)3 ∙ 18 H2O 53 

The acidified formulation also contains synthetically produced sulfuric acid.

During the Spring 2016 in-person public comment session at the National Organic Standards Board 

meeting in Washington, DC, the board received one public comment that stated that there are OMRI 

listed poultry litter amendments currently in use. The Board was provided information from a 

manufacturer of a poultry litter amendment product, which is currently OMRI listed, that expressed

concerns they had with the TR. The commenter felt that the board should not approve synthetic poultry 

litter amendments when there are already effective OMRI listed products being used in the marketplace.

Category 1: Classification 

1. Substance is used for: Livestock 

 

2. For LIVESTOCK use: 

a. Is the substance agricultural or non-agricultural? This substance is non-agricultural

b. If the substance is non-agricultural, is the substance: non-synthetic or synthetic. This 

substance is synthetic

The manufacturing process for all the forms of aluminum sulfate included in the petition 

involves reacting liquid sulfuric acid with either bauxite ore containing aluminum hydroxide 

(Al(OH) 3) and hydrated aluminum (Al2O3∙3H2O), or synthetic hydrated aluminum 

previously refined from bauxite. Bauxite ore is the main source of aluminum for the world 

and contains various aluminum minerals and two iron minerals (Amethyst Galleries 2014). 

The process creates hydrated aluminum sulfate per the following reactions: 

From bauxite: 3 H2SO4 + 2 Al(OH)3 + 12 H2O → Al2(SO4)3 • 18 H2O 52 

From hydrated aluminum: 3 H2SO4 +Al2O3∙3H2O + 12 H2O → Al2(SO4)3 ∙ 18 H2O 53 

The acidified formulation also contains synthetically produced sulfuric acid.

 

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3. For LIVESTOCK: This product would be listed at 205.603 Livestock Production-Synthetic. The 

substance contains sulfur. The substance is not an inert ingredient. Aluminum sulfate is not 

classified by the EPA as an inert of toxicological concern (it is on EPA List 4 (2004)). The 

substance is, however, approved as an adjuvant, used pre-harvest, and is exempted from the 

requirement of a tolerance (40 CFR 180.920). 

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)]

TR LINES 435-478

Aluminum sulfate is being petitioned as an amendment to poultry litter for consideration in 

organic livestock application. Aluminum sulfate undergoes various chemical interactions with 

the poultry litter, altering several key chemical characteristics of the litter: 

1. The pH of the litter is reduced; however it is unlikely to fall below pH 7.0 in litter collected 

after the final grow out flock. Initially the treated litter pH does fall to about 5.7 and that pH is 

maintained for about 3-4 weeks (Moore et al. 2000) (Table 2). 

2. Aluminum sulfate reacts with water and naturally-occurring NH3 in the litter to form NH4+, 

thus stabilizing nitrogen and reducing NH3 gas volatilization to the atmosphere. In the soil 

environment, NH4+ is transient and is either rapidly taken up by plants, microbially transformed 

to NO32- which can be taken up by plants or lost to leaching, or anaerobically transformed by 

microorganisms to N2 and N2O which are lost to the atmosphere (Halvin et al. 2005). Although 

nitrogen is more persistent in the litter, there is no effect on cumulative soil nitrogen 

accumulation compared to non-treated litter, as aluminum sulfate does not alter the organic 

fraction of the total nitrogen. 

Poultry litter is a significant source of NH3 in the atmosphere, which causes formation of aerosol 

particles. It is also a source of nitric acid deposition to land or water bodies where it causes land 

and water acidification and nitrate pollution (NOAA 2000). Aluminum sulfate decreases 

atmospheric pollution of NH3 by reducing litter pH, which converts NH3 to water-soluble NH4+ 

(Shah et al. 2006). Incubation studies estimate approximately 14 g N / kg litter is lost from nontreated litter as NH3, while ammonia loss from litter treated with aluminum sulfate ranges 

between 0.7 to 4.07 g N / kg litter between the high and low application rates (Moore et al. 

2000. Assuming 40,000 lbs. of litter for a 16,000 square foot poultry house containing 20,000 

broilers (Moore and Watkins 2012), this represents a reduction of about 400 lbs. of NH3-N lost 

to the atmosphere over a 42-day period with low rates of aluminum sulfate, and about 560 lbs. 

of NH3-N at high rates of aluminum sulfate. 

3. Litter treated with aluminum sulfate contains less soluble phosphate (PO43-) than nontreated litter, as Al3+ reacts with PO43- to form insoluble AlPO4 (Table 2). Although the total 

phosphorous concentration in the litter does not change greatly, phosphorous becomes less 

plant-available, and likelihood of phosphorous transport to surface water is reduced. Aquatic 

ecosystems tend to be phosphorous-limited, and phosphorous eutrophication of natural water 

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bodies is reduced when land-applied litter is treated with aluminum sulfate. The insoluble 

aluminum phosphate is not available to plants as nutrients and instead stays in the soil as a 

mineral (Moore and Edwards 2005). 

4. Litter treated with aluminum sulfate contains both higher total aluminum and higher soluble 

aluminum than non-treated litter (Table 2); however, runoff from fields where aluminum 

sulfate-treated litter is applied does not contain significantly higher levels of aluminum than 

fields where non-treated litter is applied (Moore et al. 1998). 

5. Litter treated with aluminum sulfate contains higher total sulfur and higher soluble sulfur 

than non-treated litter (Table 2). 

6. Concentration of soluble arsenic is reduced by aluminum sulfate treatment due to arsenic coprecipitation by aluminum (Violante et al. 2006) (Table 2). 

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)]

TR LINES 356-387

Toxicity: Aluminum sulfate is considered a dry acid, and is an irritant to the skin and eyes (UNLIO 2012). However, acidity created by the substance is neutralized by the litter, and litter 

applied to land generally has a near-neutral pH (Sims and Luka-McCafferty 2002). 

Mode of action: Aluminum sulfate reacts with water to create acid, which reduces ammonia 

losses from litter in confined poultry operations. Furthermore, aluminum causes precipitation of 

phosphates, reducing phosphorus solubility in the land-applied litter (Moore and Watkins 2012). 

Breakdown products: Breakdown products of aluminum sulfate include Al3+, Al(OH)2+, 

Al(OH)2+, Al(OH)3, SO42-, HSO4-, and H2SO4, and H3O+ (McBride 1996). Aluminum phosphate 

(Al(PO4)) precipitate is also formed via reaction of Al3+ with phosphates in the litter (Warren et 

al. 2008). 

Toxicity of breakdown products: Free Al3+ is a toxic species that increases in concentration as 

pH decreases, and typically reaches phytotoxic levels when pH falls below 5.0 (Havlin et al. 2005). 

Poultry litter without aluminum sulfate typically ranges in pH from 8.0 to 8.9 (Sims and LukaMcCafferty 2002). Shortly after aluminum sulfate application, pH of the litter decreases to about 

5.7, but becomes neutralized (near pH 7.0) after 3-4 weeks due to reaction with NH3 in the 

poultry guano (Moore et al. 2000). Thus, although adding aluminum sulfate increases total 

concentration of aluminum, persistence of the toxic Al3+ species is not enhanced. In contrast, 

application of litter near pH 7.0 to acidic soils decreases solubility of toxic Al3+ (Moore and 

Edwards 2005). 

 

Persistence of the breakdown products: Aluminum hydroxide and phosphates from aluminum 

sulfate addition to poultry litter are persistent in the soil after land application due to low 

solubility (Warren et al. 2008). Sulfates, however, are more soluble, serve as a source of sulfur 

for crop plants, or are lost to leaching (Havlin et al. 2005). 

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Contaminants: The primary contaminants present in the Al2O3 precursor to aluminum sulfate 

include SiO2, Fe2O3, and Na2O, and could carry though into the final aluminum sulfate product, 

however do not pose toxicological concerns (Carter and Norton 2007) 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

TR LINES 392-429

Aluminum sulfate is a dry acid, and can create zones of high acidity if accidentally spilled. Acid 

damage severity from a concentrated spill is dependent on the quantity spilled, and also on the 

moisture available for reacting. If the spilled material does not come into contact with moisture, 

the majority of the material could be cleaned up before significant acidification occurs. . But, 

surfaces of most soils are typically fissured and loose, and sometimes moist, making complete 

soil cleanup unlikely. Aluminum sulfate is designated as a hazardous substance under the 

CERCLA (superfund), and discharges exceeding 5,000 lbs (2,270 kg) require notification to the 

U.S. Environmental Protection Agency (TABLE 302.4 40 CFR). 

Localized environmental acidification has a profound impact on chemical equilibrium regulating 

biological systems. In the soil, acidic conditions cause enhanced solubility of the Al3+ species, 

which is toxic to plant roots. Furthermore, both H+ and Al3+ are more strongly adsorbed to soil 

cation exchange sites than calcium, magnesium, and potassium and cause potential soil 

depletion of these nutrients via leaching. Soil remediation of large aluminum sulfate spills can be 

accomplished with a liming agent to neutralize the acidity and reduce solubility of Al3+ (NIH 

2014). 

Aluminum sulfate is sometimes deliberately added to water bodies impaired by phosphorus 

eutrophication, but accidental discharge of large quantities could cause excessive water 

acidification and subsequent solubilization of Al3+ which is toxic to aquatic organisms (UN-ILO 

2012). 

Personal protective equipment should be used when applying aluminum sulfate in the poultry 

house, but no specific precautions are needed for handling spent litter treated with aluminum 

sulfate due to the high level of dilution in the litter. In the poultry house, any aluminum sulfate 

spills should be incorporated into the litter to prevent ingestion by the birds (Walker and Burns 

2000). Applications of liquid ammonium sulfate are typically made by certified applicators due 

to transport restrictions (Moore and Watkins 2012). 

Aluminum sulfate reduces environmental contamination of phosphorus in natural water bodies 

from surface litter applications, compared to non-treated litter. Moore and Edwards (2005) 

measured 340% greater cumulative phosphorus load in runoff water from non-treated litter 

than from treated litter in a paired watershed study. 

The process of extracting bauxite ore has a deleterious impact on the environment through 

habitat degradation and fragmentation by roads, and through carbon emissions (Cooke 1999). 

After extraction, regulations in some countries require replacement of topsoil and other 

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remediation measures; however quality of land after remediation is unlikely to be equivalent to 

before-extraction parameters (Cooke 1999). Most of the bauxite extraction worldwide is for the 

production of aluminum oxide, and less than 5% of bauxite imported into the U.S. is used for 

other purposes including aluminum sulfate production (USGS 2014) 

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]. 

TR LINES 544-563

Aluminum sulfate reacts with water to form sulfuric acid, which is an irritant. Aluminum sulfate 

is corrosive to the eyes; skin contact causes a rash and burning feeling, and inhalation causes 

throat and lung irritation (New Jersey Department of Health 2009). The magnitude of the toxic 

response to aluminum sulfate is completely dose-dependent, and the substance is permitted as 

a food additive in small quantities. Minor ingestion of dilute solutions causes stomach upset, 

while substantial ingestion can rarely cause hemorrhagic gastritis, circulatory collapse and multiorgan failure (United Kingdom National Poisons Information Service 1996). 

Aluminum is a subject of medical contention with suspected links to Alzheimer’s disease. 

Implications of a link between Alzheimer’s disease and aluminum have been made for 

approximately 40 years. The current large body of research has not concluded specific roles of 

aluminum in contributing to Alzheimer’s disease, but also has not dismissed aluminum as a noncontributor to the disease (Agency for Toxic Substances and Disease Registry 2008; Exeley 2001). 

Under FDA regulations, aluminum sulfate is generally recognized as safe (GRAS) as a food 

additive when used in accordance with good manufacturing or feeding practice (CFR 

182.1125(b)). 

Although aluminum sulfate has chronic toxicity for human exposure, use of the substance as 

petitioned should not have negative effects on human health. Use of the substance as 

petitioned decreases ammonia concentration in the atmosphere of poultry houses, which has a 

positive impact on both health of the birds and health of workers (Moore et al., 2000).

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)] 

TR LINES 485-522

Aluminum sulfate is not applied while birds are in the poultry house. The substance is not 

applied before the first flock grow-out; however, it is systematically applied thereafter before 

every flock is exposed to the litter. Any spills or concentrations of the product should be 

dispersed into the litter to avoid consumption by young chicks (Walker and Burns 2000). As 

stated in the petition, aluminum sulfate is not applied to feed. In the event of accidental 

ingestion, aluminum sulfate is corrosive and irrigating to the digestive system and kidneys of 

birds (Dumonceaux and Harrison 2013). In one study, Japanese quail fed aluminum sulfate as 

>0.10% of their diet reduced body weight accumulation, eggshell strength, plasma inorganic 

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phosphorous, feed consumption, and egg production (Hussein et al. 1988). Physiological effects 

of aluminum sulfate intake by broiler chickens occurs at higher intake levels than quail, with 

decreases in weight gain when consumed at >0.93% of the diet. Higher concentrations of 

aluminum sulfate in the diet cause more severe depressions in weight gain, decreased bone 

strength, and serum phosphorous. At application rates of 100 g / kg litter, birds would need to 

ingest 10% of total dietary intake as litter to exceed 0.93% aluminum sulfate in the diet, and the 

aluminum would need to be in the original non-reacted aluminum sulfate crystalline form which 

does not persist in the presence of moisture. Typical observed litter ingestion rates are below 

this threshold, ranging from 2% to 5% of daily dietary intake. Aluminum sulfate is toxic to 

poultry if directly ingested in large quantities, but not at levels expected from litter consumption 

(Huff et al. 1996). When aluminum sulfate is used, mortality decreases and poultry weight gain 

increases, indicating the birds are likely not suffering toxic effects from incidental aluminum 

sulfate ingestion from the litter (Walker and Burns 2000). 

Deleterious effects of aluminum sulfate on the head, skin, feathers, or feet of poultry were not 

revealed in the literature review, but the material is an irritant (UN-LIO 2012). If aluminum 

sulfate remains in its original non-reacted dry form, there is potential for foot irritation. 

Producers can mitigate the potential of bird exposure by rototilling aluminum sulfate into the 

litter after application, and before birds are placed back in the poultry house. Liquid 

formulations are less likely to expose birds to concentrations of the chemical due to greater 

dispersal in the litter compared to dry formulations (Moore and Watkins 2012). Aluminum 

sulfate tends to dry out the litter, and in turkeys the use of aluminum sulfate decreased the 

incidence of foot pad dermatitis, which is associated with wet litter (Wu and Hocking 2011). 

In addition to the phosphorous-fixing properties of aluminum sulfate, litter treated with 

aluminum sulfate inhibits microbial phosphorous mineralization from organic matter (Warren et 

al. 2008). Although the literature review did not reveal problems associated with salinity of litter 

treated with aluminum sulfate, treated litter contains higher levels of soluble NH4+, and sulfur; 

thus, the salinity is likely higher than non-treated litter. However, salt damage to crops at 

normal agronomic application rates is likely low due to dilution factors (Sims and LukaMcCafferty 2002). Effects on bird health are positive, as ammonia accumulation causes lung 

irrigation to poultry (Walker and Burns 2000). Pathogen loads in the broiler house are reduced 

with aluminum sulfate, which combined with lower ammonia concentration in the air causes 

increased bird weight gain (Shah et al. 2006).

6. Are there any adverse impacts on biodiversity? (§205.200) 

Aluminum sulfate reacts with water and naturally-occurring NH3 in the litter to form NH4+, thus 

stabilizing nitrogen and reducing NH3 gas volatilization to the atmosphere. In the soil 

environment, NH4+ is transient and is either rapidly taken up by plants, microbially transformed 

to NO32- which can be taken up by plants or lost to leaching, or anaerobically transformed by 

microorganisms to N2 and N2O which are lost to the atmosphere (Halvin et al. 2005). Although 

nitrogen is more persistent in the litter, there is no effect on cumulative soil nitrogen 

accumulation compared to non-treated litter, as aluminum sulfate does not alter the organic 

fraction of the total nitrogen.

Litter treated with aluminum sulfate contains less soluble phosphate (PO43-) than non-treated 

litter, as Al3+ reacts with PO43- to form insoluble AlPO4 (Table 2). Although the total 

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phosphorous concentration in the litter does not change greatly, phosphorous becomes less 

plant-available, and likelihood of phosphorous transport to surface water is reduced. Aquatic 

ecosystems tend to be phosphorous-limited, and phosphorous eutrophication of natural water 

bodies is reduced when land-applied litter is treated with aluminum sulfate. The insoluble 

aluminum phosphate is not available to plants as nutrients and instead stays in the soil as a 

mineral (Moore and Edwards 2005). 

Litter treated with aluminum sulfate contains both higher total aluminum and higher soluble 

aluminum than non-treated litter (Table 2); however, runoff from fields where aluminum 

sulfate-treated litter is applied does not contain significantly higher levels of aluminum than 

fields where non-treated litter is applied (Moore et al. 1998). 

Litter treated with aluminum sulfate contains higher total sulfur and higher soluble sulfur than 

non-treated litter

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)]

Alternatives to litter amendments include management practices such as proper air exchange in 

barns, removing caked areas and keeping litter areas dry.

TR LINES 569-581

Clinoptilolite is a naturally-occurring aluminosilicate zeolite which can absorb ammonia, 

reducing volatilization to the atmosphere. The literature contains results of mixed efficacy for 

this material, with some reports of decreased ammonia in broiler house air, and other reports of 

increased atmospheric ammonia (Amon et al. 1997; Karamanlis et al. 2008; Shah 2006). 

Agricultural lime can be applied to litter between flocks to increase litter pH, chemically inducing 

volatilization of large quantities of ammonia. The volatized ammonia can then be removed by 

ventilation before birds are placed back in the poultry house. Removal of ammonia from litter in 

between flocks reduces ammonia concentration in air for the subsequent grow-out, but does 

not mitigate ammonia production during the grow-out compared to acidification products. 

Although lime does not decrease total atmospheric ammonia pollution like aluminum sulfate, 

phosphorous in the litter is stabilized by complexation with calcium at high pH to reduce 

eutrophication of natural water bodies after land application of the litter (Shah 2006).

During the Spring 2016 in-person public comment session at the National Organic Standards 

Board meeting in Washington, DC, the board received one public comment that stated there are 

OMRI listed poultry litter amendments currently in use. The Board was provided information 

from a manufacturer of a poultry litter amendment product, which is currently OMRI listed, that 

expressed concerns they had with the TR. The commenter felt that the board should not 

approve synthetic poultry litter amendments when there are already OMRI certified listed being 

used in the marketplace. 

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2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

Yes, but it is unclear if this substance is needed in organic agriculture as alternatives exist. The 

subcommittee would like to pose the following questions:

1. Are there alternatives available to reduce Ammonia in poultry barns?

2. Do the alternatives work in the area of reducing or eliminating Salmonella that could be 

present in barns?

Classification Motion: Move to classify aluminum sulfate as petitioned as synthetic 

Motion by: Ashley Swaffar 

Seconded by: Harriet Behar 

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

Listing Motion: Motion to add aluminum sulfate as petitioned at §205.603

Motion by: Ashley Swaffar 

Seconded by: Jean Richardson

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

261/279
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National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Sodium Bisulfate

June 21, 2016

Summary of Petition: 

In April 2014 the NOP received a petition to add Sodium Bisulfate to the National List of synthetic 

substances allowed for use in organic livestock production 7 CFR 205.603 as a poultry litter treatment. 

Summary of Review:

Manufacture and Uses of the Substance:

The petitioned purpose for sodium bisulfate, in the form of the commercial product PLT®, is to control 

ammonia in poultry houses for all species of domestic fowl in the Galliformes order (includes chickens, 

turkeys, quail, pheasant, etc.) and Anseriformes, which includes waterfowl. It is intended as a topical 

litter and dirt pad treatment. It is not intended for use in feed, food or drinking water. It is being 

petitioned for addition to §205.603 as a poultry litter additive. According to the petitioner, litter 

amendments such as sodium bisulfate minimize ammonia volatilization, improve poultry health and 

maximize the litter’s agronomic, environmental, and financial value.

Sodium bisulfate is used as a top dressing to poultry litter to control ammonia in poultry houses. It is 

widely used in the commercial poultry industry (Blake and Hess 2001). It is also used in the dairy 

industry to reduce bacterial counts in bedding and ammonia emissions, preventing environmental 

mastitis and calf respiratory stress (Sun, et al. 2008). Sodium bisulfate has been successfully used in 

commercial applications in a wide variety of animal housing types, including dry litter in broiler, turkey 

and layer facilities; deep bedding for horses (Sweeney, Scanlon, et al. 2000), swine and cattle; and freestall and dry lot dairy housing systems. Specific application rates and application timings are necessary 

for reduction in environmental ammonia levels, as well as for reduction of food-borne pathogens and fly 

control purposes. Floor-raised poultry are typically kept on litter that starts out as new bedding and 

becomes a mixture of decomposing manure, spilled feed, feathers and bedding throughout the life of 

the flock. For commercial broiler houses in the U.S., bedding is typically placed in the poultry house once 

per year and then reused repeatedly over several flocks (Moore, et al. 1995). This is known as built-up 

litter. Built-up litter is a major source of volatilizing ammonia, and litter management is a key factor 

affecting ammonia levels and emissions. Sodium bisulfate is typically added to poultry litter prior to the 

placement of chicks. The high temperatures during brooding (28-34°C or 82-93°F) enhance ammonia 

volatilization at a time when chicks are most susceptible to the health challenges associated with 

elevated ammonia levels (more than 25 ppm).

Sodium bisulfate application rates of 93-100 lbs. per 1,000 ft2 controlled ammonia levels for up to 30 

day relative to the untreated control (McWard and Taylor 2000). By this time the critical brooding period 

is over. Multiple applications at the manufacturer’s recommended rate in two-week intervals reduced 

ammonia concentration by 56.6% and 21.8% at days 42 and 57, respectively (Purswell, et al. 2013). 

Growth rate and feed efficiency were not affected by repeated additions of the sodium bisulfate litter 

amendment with the birds present. 

In addition to the control of ammonia levels in poultry houses, litter treatments have also been found to 

be effective in reducing litter microbial populations. This can be beneficial in controlling food-borne 

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pathogens such as Campylobacter and Salmonella (Line 2002). Reducing the level of microbial 

contamination of litter is also important when the litter is removed and used as a fertilizer. Potential 

contamination of fresh fruits and vegetables grown on fields with applied animal manures is an 

increasing food safety concern (Hanning, Nutt and Ricke 2009). 

The use of sodium bisulfate as a litter amendment reduces atmospheric ammonia content and reduces 

the frequency and populations of the human pathogen Campylobacter. A further benefit discovered 

includes significant reductions in the population of darkling beetles, a common poultry house pest 

(Terzich 1997). 

For many years sodium bisulfate has been used as a pH reducer in a variety of agricultural, industrial, 

and food applications. The anti-bacterial properties of sodium bisulfate have been exploited in its 

application as a toilet bowl cleaner (EPA Reg #1913-24-AA) and as a preservative in EPA method #5035 

“Closed-System Purge-and-Trap & Extraction for Volatile Organics in Soil and Water samples” to prevent 

microbial activity leading to release of volatile organic compounds (VOC). 

Historically sodium bisulfate is a by-product from the manufacture of nitric acid from sodium nitrate and 

sulfuric acid. The by-product is referred to as niter cake. Today there are two methods for producing 

sodium bisulfate. One involves mixing sodium hydroxide with sulfuric acid which will react to form 

sodium bisulfate and water as shown in the equation below. This method, produced by JOST Chemical® 

(Jost Chemical 2014), results in a sodium bisulfate monohydrate which is used as a laboratory reagent. 

NaOH + H2SO4 → NaHSO4 + H2O 

The petitioner states that they use another sodium bisulfate production method that involves reacting 

sodium chloride (salt) and sulfuric acid at elevated temperatures to produce sodium bisulfate and 

hydrogen chloride gas as shown in the equation below. 

NaCl + H2SO4 → NaHSO4 + HCl 

According to the petitioner, the liquid sodium bisulfate is then sprayed and cooled so that it forms solid 

beads. The hydrogen chloride gas produced is dissolved in water to produce hydrochloric acid, which 

may be sold as a by-product.

During the Spring 2016 in-person public comment session at the National Organic Standards Board 

meeting in Washington, DC, the board received one public comment that stated there are OMRI listed 

poultry litter amendments currently in use. The Board was provided information from a manufacturer 

of a poultry litter amendment product, which is currently OMRI listed, that expressed concerns they had 

with the TR. The commenter felt that the board should not approve synthetic poultry litter 

amendments when there are already effective OMRI listed products being used in the marketplace.

Category 1: Classification 

1. Substance is used for: Livestock 

2. For LIVESTOCK use: 

a. Is the substance agricultural or non-agricultural? This substance is non-agricultural 

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b. If the substance is non-agricultural, is the substance: non-synthetic or synthetic. This 

substance is synthetic

3. For LIVESTOCK: 

This product would be listed at 205.603 Livestock Production-Synthetic. Sodium bisulfate is a 

synthetic substance in that it is manufactured using a chemical process where sodium hydroxide 

interacts with sulfuric acid. 

A) Sodium bisulfate contains sulfur (S) in the form of bisulfate (HSO4-). It is not a toxin produced 

from bacteria. Sodium bisulfate is not a pheromone, horticultural oil, fish emulsion, treated seed, 

vitamin or mineral. Although not a soap, sodium bisulfate is a key ingredient in several cleansers. 

Sodium bisulfate is not a livestock parasiticide or medicine. It is not a physical production aid 

such as netting, insect trap, sticky barrier, etc. It does function as a production aid in that it is a 

litter amendment to control ammonia levels in the poultry house. 

B) Sodium bisulfate is an inert ingredient which is not listed on EPA List 4 (7 U.S.C. 

§6517(c)(1)(B)(ii)), but is exempt from a requirement of a tolerance per 40 CFR part 180. An EPA 

final rule published in the Federal Register (Federal Register 2014) established an exemption 

from the requirement of a tolerance of residues of sodium bisulfate when used as an inert 

ingredient in antimicrobial formulations on food contact surfaces. This exemption applies to its 

use in public eating places, dairy processing equipment and food processing equipment and 

utensils at no more than 2,000 ppm in final formulation. The regulation was effective June 6, 

2014.

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)]

TR LINES 434-441

Sodium bisulfate should not be mixed with chlorine bleach or ammonia cleansers. In addition, 

sodium bisulfate should not be mixed with sodium carbonate or sodium hypochlorite, which are 

both approved substances for use in organic production. Sodium carbonate is a §205.605 (a) 

nonsynthetic allowed substance, and may be used as a natural cleaning product on organic 

operations. Sodium hypochlorite is on §205.601 as a synthetic allowed as an algaecide, 

disinfectant and sanitizer. Sodium hypochlorite is also on §205.603 as a synthetic allowed for 

disinfecting and sanitizing facilities and equipment. Sodium sulfate should not, therefore, be 

used when sodium hypochlorite has been used for disinfecting and sanitizing poultry facilities.

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)]

TR LINES 346-368 and 375-387

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Sodium bisulfate is hygroscopic in that it attracts water. Sodium bisulfate dissociates completely 

in water into sodium (Na+), hydrogen (H+) and sulfate (SO4-2). As a mineral acid, sodium 

bisulfate is not expected to contaminate ground water or soil or to accumulate in the food chain 

(EPA 1993). 

Without the addition of the sodium bisulfate, the nitrogen present in the litter would be lost as 

volatile ammonia. Sodium bisulfate captures this nitrogen, increasing the nitrogen content of 

the litter (Choi and Moore Jr. 2008). Sodium bisulfate-treated chicken litter also provides a 

nitrogen source in a form that plants can use immediately (ammonium sulfate). Ammonium 

sulfate is available to plants as a nitrogen source. In the soil the ammonium ion is released and 

forms a small amount of acid, lowering the soil pH while contributing nitrogen for plant growth. 

In commercial fertilizers, nitrogen is supplied in the form of ammonium nitrate. The nitrogen 

content of ammonium sulfate is lower – 21% nitrogen and 24% sulfur, compared to ammonium 

nitrate (NH4NO3) with 34% nitrogen. 

Bacterial levels in poultry litter have been shown to decrease as pH decreases. The use of PLT® 

has been shown to reduce survivability of E. coli and Salmonella in broiler house litter (Pope and 

Cherry 2000). As such, sodium bisulfate may be a beneficial component for pathogen reduction, 

and could play a role in an on-farm HACCP (Hazard Analysis and Critical Control Points) program, 

although further research is needed (Pope and Cherry 2000).

PLT® is reported to be 93.2% pure, with 6.8% sodium sulfate as an impurity. Sodium sulfate is 

also produced in the reaction of sodium bisulfate and ammonia, but has not been shown to be a 

concern for the welfare of the flock or the environment. In fact, sodium sulfate can be used as a 

source of sodium without chloride in poultry diets (Jankowski, et al. 2011).

The mode of action of sodium bisulfate with ammonia is unrelated to the type of litter used. The 

only effect of litter type is the amount of moisture and thus the amount of ammonia produced. 

For example, sand, grass and newspaper litters volatilize greater amounts of ammonia than 

wood shavings (Garces, Chilundo and Jairoce 2013). Bedding materials help absorb moisture, 

limiting the production of ammonia gas and growth of harmful pathogens. Historically, pine 

shavings have been used as poultry bedding and are the standard to which other materials are 

compared. There are some regional variations in bedding material, with peanut hulls sometimes 

used in Georgia and Florida, or rice hulls in Arkansas and Mississippi. Other bedding materials 

studied include, but are not limited to, pine bark, chipped pine, mortar sand, ground hardware 

pallets, chopped straw, ground door filler, and cotton-gin trash (Bilgili, et al. 2009). While 

bedding material in poultry houses must be absorbent, it must also dry quickly. Paper products 

absorb moisture well but do not dry out appropriately. This can lead to caking, especially around 

the waterers, which can cause increased ammonia production, footpad lesions and breast 

blisters (Bilgili, et al. 2009).

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

TR LINES 393-428

The hydrogen chloride gas produced in the production of sodium bisulfate is absorbed in water 

to produce hydrochloric acid which can be sold as a co-product. There are no other materials 

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requiring disposal. Quality control measures used in the manufacturing of sodium bisulfate 

ensure that all the starting materials are converted to final products so that no waste is 

generated.

EPA’s Envirofacts Master Chemical Integrator (EMCI) (EMCI 2009) references the Environmental 

Defense Fund’s Chemical Score Card for sodium bisulfate (Chemical Scorecard 2011). The 

chemical scorecard summarizes information about the health effects, hazard rankings, industrial 

and consumer product uses, environmental releases, risk assessment values and regulatory 

coverage for different products. They use a three ranking system looking at human health, 

ecological health and integrated environmental rankings. They rank products from least 

hazardous to most hazardous in a scale from 0-100. Worker exposure hazard score for sodium 

bisulfate was 18. The environmental hazard value score was 15, and the total hazard value score 

was 12. Sodium bisulfate has a safe ranking for EPA’s Design for the Environment (DfE) program 

(DfE 2014).

In general, mineral acids such as ammonium sulfate (by product of sodium bisulfate treated 

litter) will dissociate and release hydrogen ions in the environment thus decreasing the pH. The 

extent and duration of this decrease in pH will depend on the amount of neutralizing ions 

present, the buffering capacity of the medium, and the amount of dilution possibilities. However, 

ammonium sulfate only exerts a small decrease in pH. For example, the application of an 

ammonium sulfate fertilizer 21-0-0 at 10 lbs per 1000 square feet changes the soil pH from 7.5 

to 7.4 (Mason 2008). There was no literature to suggest that repeated applications of sodium 

bisulfate treated litter would lead to decreases in soil or water pH. .

Sodium bisulfate is harmful if swallowed in large amounts (ScienceLab.com MSDS 2014). 

Symptoms of swallowing more than one tablespoon of sodium bisulfate include burning pain in 

the mouth, diarrhea, vomiting and severe low blood pressure. If sodium bisulfate touches 

human skin, symptoms may include blisters, burns and painful red skin. If sodium bisulfate gets 

in eyes there may be decreased vision, eye pain, eye redness and tearing (ScienceLab.com MSDS 

2014). 

Sodium bisulfate is incompatible with strong bases, strong oxidizing agents, sodium carbonate 

and sodium hypochlorite. It should not be mixed with chlorine bleach or ammonia cleansers. 

The levels at which sodium bisulfate is added to poultry litter in broiler houses has been shown 

to have no statistically significant effect on the incidence of foot pad lesions (Nagaraj, Wilson 

and Saenmahayak, et al. 2007). Multiple additions of the product PLT during broiler grow out 

effectively controlled ammonia volatilization from litter with no reduction in foot pad quality 

(Purswell, et al. 2013).

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]. 

TR LINES 506-511

Sodium bisulfate is typically spread mechanically on litter prior to bird placement. It must be 

hand applied when birds are in the house. Sodium bisulfate is considered hazardous by the 

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OSHA Hazard Communication Standard (29 CFR 1910.1200) in that it causes serious eye 

irritation, may cause respiratory irritation, and may be harmful if swallowed. When handling 

sodium bisulfate, it is important to use personal protective equipment. Breathing in dust must 

be avoided. It is important to wash thoroughly after handling sodium bisulfate. The material is 

hygroscopic and will readily absorb moisture.

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)] 

TR LINES 445-484

According to the EPA website (EPA 2014), toxicity tests of sodium bisulfate with mosquitos, 

green algae and water fleas showed that it is not acutely toxic. The research, however, is very 

old (Anderson 1946, Dowden and Bennett 1965). More recent data could not be located. 

Sodium bisulfate is used as a means of chemically preserving soil samples to prevent the 

microbiological degradation of volatile organic compounds (Hewitt 1995).

Soil pH is an important chemical property because it affects the availability of essential plant 

nutrients (Lucas and Davis 1961). Most of the common crops have a wide range of pH 

adaptation. As an example, alfalfa, corn and small grains grow well in soil pH ranging from 5.7 to 

8.1. No research could be found on the maximum level of sodium bisulfate that could be added 

to soil before it would have an adverse effect on soil chemistry. No research showing effects of 

fertilizing with PLT-treated litter on soil ecosystem could be found, indicating a need for 

research in this area. The use of PLT-treated litter in the Delmarva Peninsula, a region with 

heavy broiler production, has not been shown to have negative effects on the soil when applied 

at levels applicable to the nutrient requirement of the crop being grown (Guo, N. Tongtavee and 

Labreveux 2009). 

The biggest environmental concern with respect to animal manures, including poultry litter, is 

currently phosphorus runoff (Moore Jr., et al. 1995). Phosphorus is normally the limiting 

nutrient for eutrophication, which has been identified as an important water problem in United 

States surface waters. Manure typically has a low nitrogen-to-phosphorus ratio and, if manure is 

applied to meet the nitrogen requirement of the crops being fertilized, there is a buildup of 

phosphorus in agricultural soils. Much of this soil phosphorus is lost in runoff from pastures 

fertilized with manure. As a result, much of the manure must be applied based on crop 

phosphorus requirement, limiting the potential of poultry manure as an organic fertilizer. 

Increasing the nitrogen content of the manure, by preventing volatilization, improves its value 

as an organic fertilizer, thereby reducing phosphorus buildup (Moore Jr., et al. 1995). 

To control ammonia levels in animal houses, including poultry houses, sodium bisulfate is added 

to the bedding or litter. In a study looking at the effect of sodium bisulfate on skin and hooves of 

horses, it was concluded that sodium bisulfate was safe for use in horse barns (Sweeney, 

Habecker and Russell 2000). In the study, sodium bisulfate was applied to clipped intact skin 

after a single and repetitive application. Sodium bisulfate was also applied to the sole of both 

front hooves and covered with wet gauze. Contact with moistened sodium bisulfate had no 

effect on pony skin. There were no gross changes, but contact with sodium bisulfate for 6 hours 

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on 10 consecutive days did cause mild to moderate microscopic changes. However, the duration 

of contact in the study was in excess of that expected under typical husbandry conditions. 

The addition of PLT® to poultry litter in broiler houses had no statistically significant effect on 

the incidence of pododermatitis4 (Nagaraj, Wilson and Saenmahayak, et al. 2007).

6. Are there any adverse impacts on biodiversity? (§205.200) 

TR LINES 346-368

Sodium bisulfate is hygroscopic in that it attracts water. Sodium bisulfate dissociates completely 

in water into sodium (Na+), hydrogen (H+) and sulfate (SO4-2). As a mineral acid, sodium 

bisulfate is not expected to contaminate ground water or soil or to accumulate in the food chain 

(EPA 1993). 

Without the addition of the sodium bisulfate, the nitrogen present in the litter would be lost as 

volatile ammonia. Sodium bisulfate captures this nitrogen, increasing the nitrogen content of 

the litter (Choi and Moore Jr. 2008). Sodium bisulfate-treated chicken litter also provides a 

nitrogen source in a form that plants can use immediately (ammonium sulfate). Ammonium 

sulfate is available to plants as a nitrogen source. In the soil the ammonium ion is released and 

forms a small amount of acid, lowering the soil pH while contributing nitrogen for plant growth. 

In commercial fertilizers, nitrogen is supplied in the form of ammonium nitrate. The nitrogen 

content of ammonium sulfate is lower – 21% nitrogen and 24% sulfur, compared to ammonium 

nitrate (NH4NO3) with 34% nitrogen. 

Bacterial levels in poultry litter have been shown to decrease as pH decreases. The use of PLT® 

has been shown to reduce survivability of E. coli and Salmonella in broiler house litter (Pope and 

Cherry 2000). As such, sodium bisulfate may be a beneficial component for pathogen reduction, 

and could play a role in an on-farm HACCP (Hazard Analysis and Critical Control Points) program, 

although further research is needed (Pope and Cherry 2000).

PLT® is reported to be 93.2% pure, with 6.8% sodium sulfate as an impurity. Sodium sulfate is 

also produced in the reaction of sodium bisulfate and ammonia, but has not been shown to be a 

concern for the welfare of the flock or the environment. In fact, sodium sulfate can be used as a 

source of sodium without chloride in poultry diets (Jankowski, et al. 2011).

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)]

Alternatives to litter amendments include management practices such as proper air exchange in 

barns, removing caked areas and keeping litter areas dry.

TR LINES 517-555

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A new type of litter amendment has become available which is based on dried Yucca schidigera 

whole plant. This is Eco-Gest YS® (Nova Microbial Technologies 2014), however it is unknown if 

it has been approved for use on an organic farm by any certifier or material review organization. 

Yucca extract products have already been employed as a feed additive for the control of manure 

odors in organic production (Prince Yuccaplus and Bioliquid 3000®). 

There is also a group of litter additives that can be applied to built-up litter to speed the release 

of ammonia, which is then flushed out of the poultry house before the chicks are placed. This 

would include such products as agricultural lime (CaCO3), the least effective, and burnt lime 

(CaO), the most effective, with the effectiveness of hydrated lime (Ca(OH)2) falling in between. 

This method for controlling ammonia levels in the poultry house shifts the flux in gaseous 

nitrogen to outside the poultry facility, which can have associated negative impacts on the 

surrounding environment (Kelleher, et al. 2002). 

Another group of litter amendments that have been used to control ammonia in poultry litter 

are clay-based products that adsorb odors and reduce ammonia release by absorbing moisture. 

This would include zeolite (natural clay material). Zeolite from Clean Age Minerals, Inc. (Clean 

Age Minerals 2014) has been approved by the third party material review organization, OMRI (it 

is “OMRI Listed”). Additional OMRI Listed products include Barn Fresh Plus and Activated Barn 

Fresh (Absorbent Products 2012), which are combinations of diatomaceous earth and calcium 

montmorillonite6 with added citric acid. These products are possible alternatives for sodium 

bisulfate for control of ammonia

During the Spring 2016 in-person public comment session at the National Organic Standards 

Board meeting in Washington, DC, the board received one public comment that stated there are 

OMRI listed poultry litter amendments currently in use. The Board was provided information 

from a manufacturer of a poultry litter amendment product, which is currently OMRI listed, that 

expressed concerns they had with the TR. The commenter felt that the board should not 

approve synthetic poultry litter amendments when there are already OMRI certified listed being 

used in the marketplace. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

Yes, but it is unclear if this substance is needed in organic agriculture as alternatives exist. The 

subcommittee would like to pose the following questions:

1. Are there alternatives available to reduce ammonia in poultry barns?

2. Do the alternatives work in the area of reducing or eliminating Salmonella that could be 

present in barns?

Classification Motion: Move to classify sodium bisulfate as petitioned as synthetic: 

Motion by: Ashley Swaffar 

Seconded by: Harriet Behar 

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

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Listing Motion: Move to add sodium bisulfate as petitioned at §205.603

Motion by: Ashley Swaffar 

Seconded by: Tracy Favre

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

271/279
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National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Acid Activated Bentonite

June 21, 2016

Summary of Petition: 

In April 2015 the NOP received a petition to add acid-activated bentonite to the National List of 

synthetic substances allowed for use in organic livestock production 7 CFR 205.603 as a poultry litter 

treatment. 

Summary of Review:

Manufacture and Uses of the Substance:

The primary use of acid-activated bentonite is to reduce the level of ammonia generated by certain 

urease producing bacteria commonly found in poultry litter. Additionally, it has been found to reduce 

populations of darkling beetles and pathogens in poultry litter, but no claims for these properties are 

being made in the present petition. In its finished form the acid-activated bentonite described here is 

composed of odorless, virtually dustless, free flowing granular particles which are spread over poultry 

litter by means of manually operated or tractor propelled broadcast spreaders. 

The finished product of the present petition (acid-activated bentonite, CAS# 98561-46-7) is prepared by 

treating naturally occurring bentonite clay with sulfuric acid. The product is manufactured by spraying 

46 weight percent concentrated sulfuric acid (CAS# 7664-93-9) onto a pre-weighed bed of bentonite clay 

granules (CAS# 1302-78-9) as they are tumbled in a Munsen mixer. After a short period of mixing, the 

acid-activated granules are transferred to a bagging line where 50 lb. aliquots are loaded into high melttemperature plastic bags and heat sealed. The petitioner notes that small amounts of crystalline quartz 

(CAS# 14808-60-7) occur naturally in the bentonite clay used to make the finished product.

The rate of addition to a poultry house is typically about 100 lbs/1000 ft2 of litter surface area, but can 

range up to 200 lbs/1000 ft2 depending on age and depth of litter. The product is added to the poultry 

litter only once at the beginning of each new grow out cycle. Application is typically done three days 

prior to bird placement in the house, but can be done up to the day of placement. The product can also 

be applied to bare ground after old litter is removed and before new litter is added at a rate of 100 

lbs/1000 ft2. New litter would then be added directly on top of the acid-activated bentonite. The TR 

also states (Lines 107-113), “The petitioner also describes reapplication methods in cases where 

ammonia levels exceed 25 ppm. The reapplication is intended to occur while birds are present at an 

application rate of 100 lbs/1,000 ft2, as indicated by the petitioner. Use instructions for Poultry Guard® 

do not address the need for reapplication, but do state that the product will be effective to reduce 

ammonia for several weeks. Broilers are grown out to 6 or more weeks, while other poultry such as 

laying hens and turkeys have longer grow out periods. If litter treatment loses effectiveness while birds 

are still in the poultry house, it is likely that reapplication or other ammonia mitigation measures may 

need to occur.”

273/279
Discussion:

The intended use of the petitioned substance is to reduce ammonia levels in poultry houses, which 

effectively improves the air quality and thus the living conditions of poultry. With reduced ammonia 

concentration in poultry houses, birds are at lower risk of respiratory damage, infectious disease, and 

other negative effects of ammonia, including mortality (Shah, Westerman, and Parsons 2006). One study 

associated the use of acid-activated bentonite as a poultry litter treatment with reduced instances of 

breast blisters, foot-pat dermatitis, and air-sac lesions in poultry (McWard and Taylor 2000). Use of acidactivated bentonite litter treatments is also associated with reductions in salmonella levels in litter 

(Watkins, Southerland and Hunt 2002) and darkling beetles (McWard and Taylor 2000).

According to the TR, since acid-activated bentonite is a highly acidic substance and handlers of the 

substance are required to prevent direct contact, it is reasonable to expect that direct contact of the 

substance with poultry, either on their feet or through incidental ingestion, would also pose health risks. 

The potential for direct contact depends on the structure of the poultry house. In some houses, the 

birds are placed on raised slatted flooring on top of the litter, in which case the birds would not have 

direct contact with the litter or litter treatments. Houses without raised flooring would allow birds to 

peck and scratch through the litter, posing a higher risk of direct contact with the litter treatment. Data 

is not available in the literature to quantify the amount of litter containing acid-activated bentonite that 

may be ingested by birds. It is unlikely that significant amounts would be ingested unless there was a 

shortage of suitable feed. (Lines 383-391.) 

Because the petitioned substance is applied to poultry litter, the subsequent use of the spent poultry 

litter must be considered in assessing the total impact of the petitioned substance on the agroecosystem. Spent poultry litter is typically intended for application to agricultural land for the purpose of 

improving soil fertility and organic matter content. Environmental concerns that arise from the land 

application of poultry manure include nitrogen leaching, phosphorus contamination of surface waters,

and heavy metal buildup in soils (Bolan, et al. 2010). Ammonium sulfate is produced as a result of the 

reaction between gaseous ammonia in the poultry house and the sulfate ions of the sulfuric acidactivated bentonite. Ammonium sulfate is a common water-soluble inorganic fertilizer used in 

conventional crop production. Ammonium sulfate has little to no surface volatilization loss when applied 

to most soils and is effective as a starter nitrogen source. Compared to other forms of soil nitrogen, the 

ammonium ion is less subject to leaching from clay since its positive charge keeps it held by the clay’s 

negatively charged sites (Vitosh, Johnson and Mengel 1995). However, increased loss of nitrogen 

through leaching has been associated with greater application rates of ammonium sulfate fertilizer 

(Olson 1979). Another study reported that while nitrogen derived from ammonium sulfate is more 

readily taken up by plants than nitrogen from leguminous nitrogen–fixing plants, it is also lost from the 

soil more readily in the first year after application (Harris, et al. 1993).

During the Spring 2016 in-person public comment session at the National Organic Standards Board 

meeting in Washington, DC, the Board received one public comment that stated that there are OMRI 

listed poultry litter amendments currently in use. The Board was provided information from a 

manufacturer of a poultry litter amendment product, which is currently OMRI listed, that expressed

concerns they had with the TR. The commenter felt that the board should not approve synthetic poultry 

litter amendments when there are already effective OMRI listed products being used in the marketplace. 

274/279
Category 1: Classification 

1. Substance is used for: Livestock 

2. For LIVESTOCK use: 

a. Is the substance Agricultural or non-agricultural? This substance is non-agricultural

b. If the substance is non-agricultural, is the substance: non-synthetic or synthetic. This 

substance is synthetic

The finished product of the present petition (acid-activated bentonite, (CAS# 98561-46-7) is 

prepared by treating naturally occurring bentonite clay with sulfuric acid. The product is 

manufactured by spraying 46 weight percent concentrated sulfuric acid (CAS # 7664-93-9) 

onto a pre-weighed bed of bentonite clay granules (CAS# 1302-78-9) as they are tumbled in 

a Munsen mixer. After a short period of mixing, the acid-activated granules are transferred 

to a bagging line where 50 lb. aliquots are loaded into high melt-temperature plastic bags 

and heat sealed. The petitioner notes that small amounts of crystalline quartz (CAS# 14808-

60-7) occur naturally in the bentonite clay used to make the finished product.

 

3. For LIVESTOCK: This product would be listed at 205.603 Livestock Production-Synthetic. The 

substance contains sulfur compounds (sulfuric acid). The substance is not an inert ingredient.

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)]

The literature does not indicate that the petitioned substance would have chemical interactions 

with other substances used in organic livestock production, other than the mode of action of the 

petitioned substance with poultry litter.

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)]

According to the TR, the by-products of acid-activated bentonite used as a poultry litter 

treatment are ammonium sulfate ((NH4)2SO4) and spent clay. Ammonium sulfate is produced 

as a result of the reaction between gaseous ammonia in the poultry house and the sulfate ions 

of the sulfuric acid-activated bentonite. 

Ammonium sulfate is a common water-soluble inorganic fertilizer used in conventional crop 

production. Ammonium sulfate has little to no surface volatilization loss when applied to most 

soils and is effective as a starter nitrogen source. Compared to other forms of soil nitrogen, the 

ammonium ion is less subject to leaching from clay since its positive charge keeps it held by the 

clay’s negatively charged sites (Vitosh, Johnson and Mengel 1995). However, increased loss of 

nitrogen through leaching has been associated with greater application rates of ammonium 

275/279
sulfate fertilizer (Olson 1979). Another study reported that while nitrogen derived from 

ammonium sulfate is more readily taken up by plants than nitrogen from leguminous nitrogen–

fixing plants, it is also lost from the soil more readily in the first year after application (Harris, et 

al. 1993). (TR Lines 299-312)

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)]

TR Lines 339-360

Manufacturing – Bentonite, the starting material, is sourced by quarry mining. Mining usually 

has negative environmental impacts that can include release of heavy metals to soil and water, 

and generation of the air pollutants sulfur and nitrogen dioxide, residual waste tailings, slag and 

acid drainage. The manufacturing of the acid treatment sulfuric acid generates sulfuric acid 

emissions into the air which, if not otherwise neutralized, result in dilute acid solutions that may 

contribute to acid rain. The activation of bentonite with sulfuric acid as described in the petition 

does not appear to add additional negative environmental impacts beyond the manufacturing of 

its ingredients. 

Use and Handling – The U.S. Department of Transportation regulates the shipping of acidactivated bentonite as a “corrosive material” (Hazard Class 8) due to the sulfuric acid content. 

This class of materials is defined at 49 CFR 173.136 as a liquid or solid that causes full thickness 

destruction of human skin at the site of contact within a specified period of time. Care must be 

taken to ensure that incompatible corrosive materials are not mixed. The Material Safety Data 

Sheet for the petitioned acid-activated bentonite indicates that it does not emit any volatile 

organic compounds. Applying water directly to the material must be avoided; aqueous runoff is 

acidic and corrosive. 

Misuse – Since the substance is a granular solid material, spills are relatively manageable to 

contain and clean up. The Material Safety Data Sheet for the petitioned acid-activated bentonite 

indicates that spills greater than 2,000 lbs must be reported to the National Resources Center. 

Disposal – Use instructions for Poultry Guard® state that the product can be neutralized with 

household ammonia or baking soda.

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]. 

Handlers of acid-activated bentonite must take care to protect themselves from direct contact 

with the substance. Direct exposure to the substance may cause skin irritation or burns. The 

petitioned product contains crystalline silica which is naturally occurring in the bentonite 

starting material, a small fraction (0.00064% by weight) of which is in the respirable range. 

Inhalation of excessive concentrations of the substance may lead to lung injury. Applicators 

should wear protective clothing, impervious gloves, goggles, and a dust mask. 

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Use of the substance as petitioned is not likely to have negative effects on human health 

because the substance decreases ammonia concentration in the atmosphere of poultry houses, 

which has a positive impact on both the health of the birds and the health of the handlers.

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)] 

According to the TR (Lines 376-403): The intended use of the petitioned substance is to reduce 

ammonia volatilization in poultry houses, which effectively improves the air quality and thus the 

living conditions of poultry. With reduced ammonia concentration in poultry houses, birds are at 

lower risk of respiratory damage, infectious disease, and other negative effects of ammonia, 

including mortality (Shah, Westerman and Parsons 2006). One study associated the use of acidactivated bentonite as a poultry litter treatment with reduced instances of breast blisters, footpat dermatitis, and air-sac lesions in poultry (McWard and Taylor 2000). 

Since acid-activated bentonite is a highly acidic substance and handlers of the substance are 

required to prevent direct contact, it is reasonable to expect that direct contact of the substance 

with poultry, either on their feet or through incidental ingestion, would also pose health risks. 

The potential for direct contact depends on the structure of the poultry house. In some houses, 

the birds are placed on raised slatted flooring overtop of the litter, in which case the birds would 

not have direct contact with the litter or litter treatments. Houses without raised flooring would 

allow birds to peck and scratch through the litter, posing a higher risk of direct contact with the 

litter treatment. Data is not available in the literature to quantify the amount of litter containing 

acid-activated bentonite that may be ingested by birds. It is unlikely that significant amounts 

would be ingested unless there was a shortage of suitable feed. 

The acidifying function of litter treatments can inhibit growth and survival of pathogenic and 

nonpathogenic bacteria in litter (Choi, Kim and Kwon 2008). Use of acid-activated bentonite 

litter treatments is also associated with reductions in salmonella levels in litter (Watkins, 

Southerland and Hunt 2002) and darkling beetles (McWard and Taylor 2000). 

Because the petitioned substance is applied to poultry litter, the subsequent use of the spent 

poultry litter must be considered in assessing the total impact of the petitioned substance on 

the agro-ecosystem. There are many environmental considerations if the poultry litter is applied 

to agricultural land. Some considerations are addressed in Evaluation Question #5. See Technical 

Reports for aluminum sulfate (OMRI 2015a) and sodium bisulfate (OMRI 2015b) for additional 

information regarding the reuse of treated poultry litter for fertility purposes.

6. Are there any adverse impacts on biodiversity? (§205.200) 

Because the petitioned substance is applied to poultry litter, the subsequent use of the spent 

poultry litter must be considered in assessing the total impact of the petitioned substance on 

the agro-ecosystem. Spent poultry litter is typically intended for application to agricultural land 

for the purpose of improving soil fertility and organic matter content. Environmental concerns 

that arise from the land application of poultry manure include nitrogen leaching, phosphorus 

contamination of surface waters, and heavy metal buildup in soils (Bolan, et al. 2010). 

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Ammonium sulfate is produced as a result of the reaction between gaseous ammonia in the 

poultry house and the sulfate ions of the sulfuric acid-activated bentonite. Ammonium sulfate 

is a common water-soluble inorganic fertilizer used in conventional crop production. 

Ammonium sulfate has little to no surface volatilization loss when applied to most soils and is 

effective as a starter nitrogen source. Compared to other forms of soil nitrogen, the ammonium 

ion is less subject to leaching from clay since its positive charge keeps it held by the clay’s 

negatively charged sites (Vitosh, Johnson and Mengel 1995). However, ammonium sulfate has a 

neutral charge and so would not be held to clay in the same way. Increased loss of nitrogen 

through leaching has been associated with greater application rates of ammonium sulfate 

fertilizer (Olson 1979). Another study reported that while nitrogen derived from ammonium 

sulfate is more readily taken up by plants than nitrogen from leguminous nitrogen–fixing plants, 

it is also lost from the soil more readily in the first year after application (Harris, et al. 1993).

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)]

Alternatives to litter amendments include management practices such as proper air exchange in 

barns, removing caked areas and keeping litter areas dry.

TR LINES 435-449

Clay-based adsorbents can be used to bind NH3 to the surface of the clay, and they also 

decrease NH3 volatilization by absorbing moisture (McCrory and Hobbs 2001). Nonsynthetic 

forms of these substances include naturally occurring zeolite, diatomaceous earth, and 

montmorillonite (non-activated bentonite). Peat (Sphagnum facum) has physical and chemical 

properties that result in effective ammonia management. Peat can adsorb 2.5 times its weight in 

NH3 and absorb up to 20 times its weight in water (McCrory and Hobbs 2001). Clay and peat are 

both nonhazardous materials. At the time of this report, there are several products that are 

OMRI Listed® for this use, such as Barn Fresh Natural Ammonia Control manufactured by 

Absorbent Products Ltd, which is listed in the “diatomaceous earth” category (OMRI 2015). 

Another product, Litter Life manufactured by Southland Organics, is a liquid poultry litter 

treatment that is approved under the U.S. EPA Design for the Environment program (Southland 

Organics 2015). 

Microbial and enzymatic treatments can be used to inhibit microbial growth and urease 

production through competitive exclusion and enzyme inhibition (Ritz, Fairchild and Lacy 2014).

These types of products are generally not practical or economical for growers due to the rapid

breakdown of the product, and they are more expensive than other alternatives (McCrory and

Hobbs 2001).

During the Spring 2016 in-person public comment session at the National Organic Standards 

Board meeting in Washington, DC, the board received one public comment that stated there are 

OMRI listed poultry litter amendments currently in use. The Board was provided information 

from a manufacturer of a poultry litter amendment product, which is currently OMRI listed, that 

expressed concerns they had with the TR. The commenter felt that the board should not 

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approve synthetic poultry litter amendments when there are already OMRI certified listed being 

used in the marketplace. 

2. In balancing the responses to the criteria above, is the substance compatible with a system of 

sustainable agriculture? [§6518(m)(7)]

Yes, but it is unclear if this substance is needed in organic agriculture as alternatives exist. The 

Subcommittee would like to pose the following questions:

1. Are there alternatives available to reduce ammonia in poultry barns? 

2. Do the alternatives work in the area of reducing or eliminating Salmonella that could be 

present in barns?

Classification Motion: 

Move to classify acid activated bentonite, as petitioned, as synthetic 

Motion by: Ashley Swaffar

Seconded by: Tracy Favre

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

Listing Motion: 

Move to add acid activated bentonite as petitioned at §205.603

Motion by: Ashley Swaffar 

Seconded by: Tracy Favre

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

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