National Organic Standards Board | October 2020 | Proposals & Discussion Documents 

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National Organic Standards Board Meeting 

Virtual 

October 28 - 30, 2020 

Document Page 

Compliance, Accreditation, & Certification Subcommittee (CACS) 

Discussion Document: Human Capital Management 1 

Crops Subcommittee (CS) 

Proposal: Paper (Plant pots and other crop production aids) - petitioned 3 

Proposal: Wild, native fish for liquid fish products 11 

Proposal: Sodium carbonate lignin - petitioned 21 

2022 Crops Sunset Reviews: §205.601 & §205.602 25 

Discussion Document: Ammonia Extract - petitioned 47 

Discussion Document: Biodegradable biobased mulch annotation change 49 

Handling Subcommittee (HS) 

Proposal: Low acyl gellan gum - petitioned 53 

Proposal: Ion exchange filtration 61 

2022 Handling Sunset Reviews: §205.605 & §205.606 65 

Discussion Document: Whey protein concentrate - petitioned for removal 103 

Livestock Subcommittee (LS) 

Proposal: Fenbendazole - petitioned 105 

2022 Livestock Sunset Reviews: §205.603 113 

Materials Subcommittee (MS) 

Proposal: Research Priorities 2020 133 

Proposal: Marine Macroalgae in Crop Fertility Inputs 145 

Policy Development Subcommittee (PDS) 

Discussion Document: Consent Calendar Voting 173 

PLEASE NOTE: 

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

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

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

instructions. 

 

 

 

 

 

 

 

National Organic Standards Board 

Compliance, Accreditation & Certification Subcommittee 

Request for Discussion and Recommendations: 

Human Capital Strategy for Organic Inspectors and Reviewers 

August 11, 2020 

On July 31, 2020, National Organic Program (NOP) Deputy Administrator Dr. Jennifer Tucker shared a 

memo and work agenda item with the Board, requesting that the Board facilitate a public discussion 

related to Human Capital Strategy for Organic Inspectors and Reviewers. Dr. Tucker presented a 

document discussing different elements of human capital management, focusing specifically on organic 

inspectors and reviewers. As the document notes, the topic of inspector and reviewer qualifications and 

training has been of interest to the NOP and the organic community for several years. 

This work agenda item and related paper seek to build on this ongoing discussion, summarizing a 

broader set of human capital dimensions that are needed to develop, support, and retain a robust and 

well-supported pipeline of certification professionals over time. The goal is to initiate a broader 

discussion on these topics across the organic community. The paper presents several key areas of 

human capital and poses questions to support an inclusive discussion. 

The Compliance, Accreditation & Certification Subcommittee (CACS) welcomes this discussion, is eager 

to receive feedback, and invites the community to start the conversation by submitting comments 

during the Fall 2020 open docket and webinar comment sessions. Time will be set aside during the Fall 

2020 meeting for Board discussion and consideration of comments received. We look forward to 

continued discussion across future meetings as a means to further strengthen the capacity of the 

certification and broader organic community. 

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National Organic Standards Board 

Crops Subcommittee Petitioned Material Proposal 

Paper Based Crop Planting Aids 

July 21, 2020 

Summary of Petition and Petition Addendum for Paper (Plant Pots and Containers) 

The NOSB received a petition in August 2018 for the addition of paper planting pots to the National List: 

§205.601(o) production aids- Plant pot or growing container-hemp or other paper, without glossy or

colored inks.

This material has not been petitioned for inclusion on the National List in the past. However, paper 

chain pots have been historically allowed for the past 12 years by some organic certification agencies, 

under the allowance for “Newspaper or Other Recycled Paper as a mulch or compost feedstock”. 

In February 2018, the NOP notified all certifiers that paper chain pots are not allowed in organic 

systems. However, because some certifiers had previously approved their use, NOP allowed a phase-out 

period until the end of the 2018 crop season. The NOP’s decision on this material was based primarily 

on the presence of an unapproved synthetic adhesive in the product and the use of virgin paper. 

Further, the current allowance for paper on the National List does not extend to the use associated with 

paper pots. At the October 2018 and April 2019 NOSB meetings, there were numerous oral and written 

public comments requesting a longer time period allowing use of these paper pots while the NOSB 

reviewed the petition. The NOSB also formally requested this extension in November 2018. The NOP 

agreed to allow the use of paper pots in organic agriculture in late Fall 2018, with no time restriction, in 

order to give the NOSB time to go through the review process of this material. 

Paper pots are used by small scale farming operations to efficiently transplant using a non-motorized 

machine transplanting system. More information on this transplanting method can be found on these 

websites: http://paper-pot.com/ and http://www.smallfarmworks.com/. This equipment, along with 

the paper pots, is imported from a manufacturer in Japan. According to the petition, the Nitten paper 

pot chain system uses paper, produced from a non-bleached Kraft pulp, and adhesives. Non-paper 

synthetic fibers have been used in small quantities (15%) in the paper pots, but these fibers are 

proposed to be replaced by a natural hemp fiber. The petitioner and public comment at the Spring and 

Fall 2018 NOSB meetings stated this system is unique and essential for smaller scale growers. The only 

alternative would be the much slower and more costly hand planting of individual plants. The system is 

used for closely spaced crops such as onions, beets, baby salad, etc. The petition states that, similar to 

newspaper, these pots decompose in the soil readily. At the time of this proposal, the first trial replacing 

the synthetic fibers with hemp fibers was not successful, and a second trial was in process. 

In addition to the paper pots indicated in the petition, there are numerous other paper pot systems, 

both to be used to transplant single plants as well as in chains. In addition to paper, these other paper 

pot systems have various percentages of non-paper synthetic fibers, which may or may not be biobased. 

Paper pots can also include other ingredients, such as cow manure, synthetic antimicrobials, fungicides 

and fertilizers. Public comment from another manufacturer based in Denmark, Ellepot 

(https://www.ellepot.com/), provided further information on non-chain paper pots for a variety of uses 

from fast maturing annuals to long term woody perennial crops. The percentage of cellulose based 

synthetic fibers in their paper pots can be 20-100%. Synthetic adhesives are currently the only synthetic 

material used in the Ellepots other than the paper itself. 

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The petition states that, in addition to information on paper, the TR on newspaper addresses the 

presence of adhesives and synthetic fibers in recycled newspaper as well. The three adhesives in the 

Nitten paper chain pots are vinyl-acetate resin (water soluble and stated to be leached from the pots 

before transplanting), ethylene-vinyl-acetate resin, and acrylic acid ester copolymer. 

It should be noted that paper itself is a synthetic fiber due to the manufacturing process. However, for 

the purposes of this discussion, a distinction is made between synthetic paper fibers and synthetic fibers 

that are not strictly paper. These non-paper synthetic fibers can be biobased and made from cellulose 

or they can be non-biobased and made from a number of other materials such as petroleum-based 

plastics. In general, many of the biobased, cellulose derived synthetic fibers used in paper pots are 

expected to biodegrade whereas the same might not be true of other petroleum-based fibers. Thus, it is 

important to distinguish not only between synthetic paper fibers and other non-paper synthetic fibers 

but also between whether these non-paper fibers are biodegradable (as referenced to some recognized 

standard) or might persist in the soil. 

The Crops Subcommittee has viewed paper pots, used as a crop production aid, as another use of paper 

beyond compost feedstocks and mulch, which are allowed under the NOP regulation. However, in order 

to do due diligence, the Crops Subcommittee requested a Technical Review (TR) to help identify the 

adhesives and synthetic fibers used in paper pots and identify if there are any that would not be present 

in the already allowed paper used in compost and mulch. Pots, compost, and mulch all degrade into the 

soil, and the Subcommittee believes if the fibers and adhesives are allowed in the other listings for 

paper, then their use in pots should be allowed as well. 

The Technical Review clarified that the adhesives and non-paper synthetic fibers found in a variety of 

paper pots are also found in newspaper and recycled paper that are allowed for compost feedstock and 

mulch. Other possible adhesives and synthetic fibers for paper pots that were not mentioned in the 

petition are described in the TR. 

Summary of Public Comment: 

Many users of the paper pot chain system provided written and verbal comment to the NOSB at the Fall 

2018 through Spring 2020 public meetings. They spoke in favor of its use due to its efficiency in 

transplanting at a small-scale level. Some certifiers spoke in favor of this material and noted that if the 

paper was torn off the pot before transplanting, it would then be allowed as a mulch or as a compost 

feedstock under our current regulation. Certifiers who had not allowed the use of these paper pots still 

supported the extended allowance for use while the NOSB performed its review. 

There is more than one supplier of paper pots beyond the supplier noted in the petition. Approval of this 

material will open the door for other manufacturers to produce these pots once there is clarity on what 

would be allowed under the organic regulations. Paper pots can be made with all-natural fibers or with 

a mixture of synthetic and natural fibers. The pots with higher non-paper, synthetic fiber contents are 

more typically used in the nursery trade where perennial plants may be in the pots for 9-12 months 

before transplanting into the field. Natural fiber pots can, at times, be sufficient for use in transplanting 

annual vegetable and flower plants, depending on the time frame from planting into the pot to planting 

in the field and if the pots need extra strength for a “chain of pots” planting system. All of the paper 

pots contain some type of synthetic adhesive, but these same adhesives are also found on recycled 

paper which is already allowed in organic agriculture. 

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Numerous commenters mentioned that all uses of paper as a production aid should be included when 

the NOSB does its review for paper pots. Cloches or hot caps, seed tape, and cutworm prevention 

collars are other examples of production aids made from paper and typical paper adhesives. 

There were also a number of comments about whether the listing for paper pots should be expanded to 

include additional distinct uses of paper as a production aid. Many commenters favored a listing that 

extended beyond only paper pots to include, but not be limited to, items such as seed tape, and other 

materials with direct soil contact. However, commenters also wanted to make sure that there was a 

differentiation between paper materials being used that are later incorporated into the soil versus paper 

materials that are intended to be removed after use. The Crops Subcommittee has narrowed the use 

from a “production aid” to a “planting aid” to limit the use of this paper to that period of the crop 

production, and to those aids that would be incorporated into the soil. 

Specific Uses of the Substance: 

These paper pots are either single or in chains to allow for “mechanical” transplanting, either with a 

hand driven machine or with a tractor implement. The paper pots decompose into the soil, and lessen 

transplant shock since the roots are not exposed to the air before transplanting like plants being 

removed from plastic pots. The use of paper pots can contribute to less use of plastic in the produce 

industry. Growers can also use soil blocks, which are compressed soil without any container, to grow 

transplants. 

Other paper crop production aids include: cloches (a temporary covering used to protect newly 

transplanted plants), seed tape (where individual seed is spaced correctly on a paper tape which lessens 

the need for thinning), and collars to prevent cutworm damage to plants at the soil line. There could be 

other uses of paper currently used as crop production aids or there may be other uses developed over 

time. The composition of the paper allowed in paper pots and other planting aids, as well as the 

adhesives approved, would meet the manufacturer needs of these other paper planting aids. 

Approved Legal Uses of the Substance: 

Newspaper and recycled paper are allowed under the organic regulations in these two references: 

Reference: 205.601(b) As herbicides, weed barriers, as applicable. (2) Mulches. (i) newspapers or other 

recycled paper, without glossy or colored inks. 

Reference: 205.601(c) - As compost feedstocks - Newspapers or other recycled paper, without glossy or 

colored inks. 

There have been three technical reports (TRs) for Newspaper, in 1995, 2006 and 2017, which can be 

found here: https://www.ams.usda.gov/rules-regulations/organic/national-list/n. 

NOP guidance 5034-1 “Materials for Organic Crop Production” from December 2016 excludes virgin 

paper from the “newspaper or other recycled paper” allowance for mulch or compost feed stocks. The 

guidance states: “Includes newspaper and other recycled paper such as cardboard, without glossy or 

colored inks. Does not include paper that is not recycled (i.e., virgin paper).” 

The July 2019 Technical Review of Paper Pots and Containers, detailing the specific possible synthetic 

and natural fibers as well as synthetic adhesives found in paper pots currently commercially available, 

provided more clarity for the NOSB. 

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Manufacture: 

Paper can be made from various plant sources including wood, trees, straw, hemp, bamboo, reeds, 

kenaf, sisal, jute, sugarcane bagasse, sunflower stalks as well as recycled sources of pulp. Cellulose 

sources are typically mechanically ground and then chemically “cooked” using an alkali or sulfite 

process. Newspaper and recycled papers can also have a variety of inks, although colored ink and glossy 

paper are not allowed as compost feedstocks or mulch under the organic rule. The paper used as a 

planting aid could include the typical adhesives found in newspaper and recycled paper. 

Subcommittee Discussion: 

The Crops Subcommittee has reviewed the petition, technical reviews, and public comments and have 

developed a listing and annotation that we believe meets the needs of producers while addressing 

environmental concerns that might be associated with some types of paper. When discussing the 

possible allowance for paper used as a planting aid, the subcommittee also considered the fact that 

currently there is an allowance for “newspaper or other recycled paper” as weed control or as compost 

feed stocks and there are very few differences between the currently allowed paper and the paper as a 

planting aid under review, with the exception of paper pots that have a very high percentage of noncellulose synthetic fibers. Requiring 60% cellulose fiber prevents the planting aids from being 

completely made of biobased, non-degradable plastics and yet allows current products on the market. 

It is hoped that this percentage can increase over time. Requiring 80% biobased content prevents the 

use of planting aids made primarily from petroleum sources and also allows the products currently on 

the market. Again, it is hoped that this percentage can be increased over time and that future Boards 

will be able to modify this annotation to reflect manufacturing technological advances that incorporate 

more natural materials and additional cellulose and biobased content. Small changes have been made 

to the annotation to reflect concerns from stakeholders. There is concern that the annotation 

specifically notes that allowed paper planting aids are not limited to those listed and that the materials 

will be incorporated into the soil (without reference of intent to biodegrade). Finally, as pointed out in 

public comment, the wording that allows the use of newspaper “without colored or glossy inks” was 

intended to prevent use of glossy paper and colored inks and the wording for paper planting aids is 

changed to prevent the use of glossy paper or colored inks. 

Category 1: Classification 

1. For CROP use: Is the substance _____ Non-synthetic or __x__ Synthetic?

Is the substance formulated or manufactured by a process that chemically changes a substance

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so,

describe, using NOP 5033-1 as a guide.

Due to the paper pulping production process and use of synthetic adhesives, this material is

considered to be synthetic.

2. For CROPS: Reference to appropriate OFPA category:

Is the substance used in production, and does it contain an active synthetic ingredient in the

following categories: [§6517(c)(1)(B)(i)]; copper and sulfur compounds; toxins derived from

bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and

minerals; livestock parasiticides and medicines and production aids including netting, tree wraps

and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or (ii) is used in

production and contains synthetic inert ingredients that are not classified by the Administrator of

the Environmental Protection Agency as inerts of toxicological concern?

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This material is considered a crop planting aid and is not a pesticide. Although some paper pots 

available on the market might have prohibited pesticides (insecticides, antimicrobials, fungicides 

etc.) embedded in the fiber, these would not be allowed in organic production. In order to be 

explicit, the annotation states that any added nutrients or pesticides must conform to the 

National List or be allowed under OFPA. 

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)]

Most of the paper used as a crop planting aid is functionally identical to newspaper and recycled

paper. The current listing of newspaper and recycled paper has been found to have no

detrimental interactions with other materials in organic agriculture.

2. What is the toxicity and mode of action of the substance and of its breakdown products or any

contaminants, and their persistence and areas of concentration in the environment?

[§6518(m)(2)]

No toxicity or negative mode of action has been found in the breakdown of paper (cellulose) in 

the environment. No colored inks or glossy paper would be allowed for paper as a crop planting 

aid, similar to paper as it is currently annotated as a compost feedstock and/or mulch. The 2019 

TR found many of the adhesives and synthetic fibers biodegraded with no negative impacts. 

There were some that were not as environmentally neutral as others, but all were also present 

in newspaper. The percentage of adhesives in the paper pots is very small. There could be an 

issue with paper used as a planting aid, containing large percentages of synthetic fibers that 

would not biodegrade readily. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or

disposal of such substance? [§6518(m)(3)]

There could be contaminants released into the environment during the manufacture of paper,

and environmental degradation caused by harvest of cellulose, but no more than newspaper or

recycled paper, which historically have been approved for use in organic agriculture. A

difference between this paper and the previously approved newspaper is that we are not

restricting it to the use of only recycled paper products. The annotation will allow virgin stocks

of cellulose to be used in the paper used as a planting aid in organic agriculture. There are

negative environmental impacts from harvesting trees to make paper such as road building, soil

erosion, degraded water quality, and loss of habitat, but there are forestry best management

practices that can mitigate some of these negative effects. The synthetic fibers that could be

used in paper are manufactured in a wide range of production systems. These were not

specifically addressed in the TR.

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i);

§6518(m)(4)].

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Paper, depending on the percentage of cellulose and type of synthetic fibers/materials used, is 

biodegradable and has no negative effects on human health. The 2019 TR did not find any 

evidence of harmful effects to human health. 

5. Discuss any effects the substance may have on biological and chemical interactions in the

agroecosystem, including the physiological effects of the substance on soil organisms

(including the salt index and solubility of the soil), crops and livestock. [§6518(m)(5)]

Paper, depending on the percentage of cellulose and type of synthetic fibers/materials used, is

not harmful to the environment. The 2019 TR did not find any evidence of harmful effects to

environmental health.

6. Are there any adverse impacts on biodiversity? (§205.200)

Paper planting aids with high percentages of synthetic fibers that do not biodegrade readily

could leave residues that would be harmful to terrestrial, avian and aquatic wildlife if consumed.

Use of synthetic pesticides embedded in the pots could also have adverse impacts on

biodiversity, but only organically allowable pesticides or nutrients would be allowed in the paper

used as a planting aid.

Category 3: Alternatives/Compatibility 

1. Are there alternatives to using the substance? Evaluate alternative practices as well as nonsynthetic and synthetic available materials. [§6518(m)(6)]

There are biodegradable pots made from composted cow manure (https://cowpots.com/) but

these have never been petitioned for use in organic agriculture. We do not know if they could be

approved or not. The manufacturer states the pots contain post-consumer newsprint and are

100% biodegradable. In addition, they state they are not approved for Certified Organic

operations as of January 2020. It is unclear if there are adhesives or synthetic fibers as well and

what they are.

There are also tools to help growers roll up newspaper into a pot. The paper chain pots offer

greater efficiency for small scale transplanting, although mechanical or hand transplanting

operations can be used in both small- and large-scale operations with other types of pots or soil

blocks.

2. In balancing the responses to the criteria above, is the substance compatible with a

system of sustainable agriculture? [§6518(m)(7)]

The Crops Subcommittee has developed the definition and annotation described in the motion

below to both meet the OFPA criteria and to provide a practical and achievable material for

manufacturers to produce and for organic farmers to use. The material is a planting aid and the

intent is to limit the use of this material to activities around planting of seeds or plants.

The annotation of no less than 60% cellulose-based fiber content meets the needs of current

manufacturers with the possibility that hemp or other natural cellulose fibers, capable of

providing the strength needed to meet this annotation, could be used in the future. The 80%

biobased requirement ensures that materials beyond the cellulose base are derived from

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biological sources. Both the 60% cellulosed based fiber content and 80% biobased content 

requirements could be made more stringent by future Boards through an annotation change. As 

the technology of these planting aids advances it’s possible manufacturers will be able to use 

more natural and biobased materials to strengthen the planting aids. Continuing the prohibition 

on glossy paper and colored inks prevents the incorporation into organic soil of the worst 

contaminants. It is understood that there would be a small percentage of adhesives and coatings 

and the Technical Reviews on paper and paper pots described how these are already allowed in 

paper as mulch or compost feedstocks. 

The allowance for virgin paper allows for special papers to be developed that meet the specific 

crop planting needs for a variety of uses, and the amount of paper produced from virgin sources 

for these planting aids would be very small compared to the amount of paper manufactured for 

all uses. Added fungicides, antimicrobials, insecticides or other synthetic items not typically 

found in paper would not be allowed under the current annotation unless they were on the 

National List for that purpose or otherwise compliant with the OFPA. Genetically modified 

materials are prohibited under the organic regulation and would not be allowed as ingredients in 

paper-based crop planting aids. With the recommended annotation, paper-based crop planting 

aids are compatible with a sustainable system of agriculture. 

The Crops Subcommittee did not include a biodegradability standard in this proposal due to the 

time and cost needed for testing to that standard. The Subcommittee would like to see 

continued innovation to move to 100% biobased as well as an increase in the natural fiber 

content of these planting aids. Additionally, the Subcommittee wants to make sure that these 

materials are promptly and economically available to growers of all sizes. The Subcommittee 

would like to encourage testing and trials of increased natural and/or biobased contents and 

believe that manufacturers would be less likely to provide small innovations of these new 

products to organic farmers if this testing were required. 

Classification Motion: 

Motion to classify “paper-based crop planting aid” as a synthetic substance. 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

National List Motion: 

Motion to add to 205.2 Terms Defined: 

Paper-based crop planting aid. A material that is comprised of at least 60% cellulose-based fiber 

by weight, including, but not limited to, pots, seed tape, and collars that are placed in or on the 

soil and later incorporated into the soil. Contains no less than 80% biobased content as verified 

by a qualified third party assessment (e.g. laboratory test using ASTM D6866 or composition 

review by qualified personnel). 

Motion by: Steve Ela 

Seconded by: Jerry D’Amore 

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

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Add to 205.601 (o) Production Aids: 

Paper-based crop planting aids as defined in 205.2. Virgin or recycled paper without glossy paper 

or colored inks. Added pesticides or nutrients must comply with §205.105, 205.203, and 

205.206. 

Motion by: Steve Ela 

Seconded by: Rick Greenwood 

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

Approved by Jesse Buie, Crop Subcommittee Chair, to transmit to NOP July 28, 2020 

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National Organic Standards Board 

Crops Subcommittee Proposal 

Wild, Native Fish for Fertilizer Production 

July 21, 2020 

Summary: 

The use of fish in crop fertility products has a long history in organic agriculture. Over the past 

five years, the board has heard from stakeholders about potential negative environmental 

impacts of harvesting some marine materials for organic production. The purpose of this 

proposal is to limit the impact of harvesting wild, native fish for fertilizer and to ensure that 

liquid fish fertilizer products used in organic production are not harmful to the environment. 

Background: 

As part of the most recent sunset review of Liquid Fish Products (LFPs) under Section 

205.601(j)(8) of the organic regulations, the Crops Subcommittee posed questions to 

stakeholders asking about the number of products using wild fish harvested solely for fertilizer 

versus products utilizing fish waste or byproducts. The board learned that the majority of LFPs 

use fish byproducts (offal), and some use whole fish harvested to control invasive species. At its 

Spring 2018 meeting, the board received testimony that some manufacturers are using wild, 

native fish harvested exclusively for fertilizer. Consequently, the Crops Subcommittee 

requested the development of a Technical Report (TR) on Fish-Based Fertilizers to investigate 

this further. At its spring 2020 meeting, the board put forward a Discussion Document on the 

topic soliciting stakeholder feedback. 

Relevant Areas of OFPA and the Regulations: 

OFPA Section 6517 [National List] (c) [Guidelines for Exemptions or Prohibitions] (1)(a)(i) and 

(2)(a)(i) which allows for the prohibition of synthetic or nonsynthetic substances, respectively, 

that would be “harmful to ... the environment.” 

OFPA Section 6518 [National Organic Standards Board] (m) [Evaluation] which directs the Board 

to consider—(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.” 

§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 does not contribute

to contamination of crops, soil, or water...

(j) As plant or soil amendments.

(8) Liquid fish products—can be pH adjusted with sulfuric, citric or phosphoric acid. The amount

of acid used shall not exceed the minimum needed to lower the pH to 3.5.

NOSB Policy and Procedures Manual, Principles of Organic Agriculture Organic agriculture, 

adopted 2001, 1.1 states: Organic agriculture...is an ecological production management system 

that promotes and enhances biodiversity, biological cycles, and soil biological activity. 

Discussion: 

In its TR request, the Subcommittee asked the following questions: 

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1. During the Spring 2018 public meeting, the Crops Subcommittee asked if there

are manufacturers using exclusively wild-caught, native fish to manufacture liquid

fish fertilizers and learned that there are. Public testimony suggested that other nonsynthetic fish-based fertilizers, such as fishmeal, may also be derived from wild fish

harvested solely for fertilizer production. Is any new information available about the

impact of fish fertilizer manufacturing on the sustainability and health of wild, native

fish stocks harvested solely for fertilizer production?

2. To what extent does the harvesting of wild, native fish exclusively for use as a fertilizer

harm the environment?

3. Do different methods, locations, and/or frequencies of harvest pose different levels of

risk for wild, native stocks?

4. Are there any species of wild, native fish for which there are no negative environmental

impacts of harvest?

5. Are there any fish fertilizer products derived from farmed fish, and if so, are there any

negative environmental impacts?

6. Are there any fish fertilizer products derived from wild, non-native fish populations, and

if so, are there any negative or positive environmental impacts?

7. Please describe the environmental impact of using wild, native fish harvested exclusively

for fertilizer versus using byproducts or invasive species.

8. Please provide universally agreed upon definitions of “wild, native fish”, “wildharvested”, and “invasive species”.

9. Please provide examples of non-regulatory/practice-based approaches (e.g. training,

guidance) that should be considered.

The findings of the TR were different from previous public comments. Specifically, the TR states 

that “based on available data, wild, native fish are not harvested solely for fertilizer production 

(see Table 1, in 268 Specific Uses of the Substance) (OMRI, 2019a). Rather, fish waste or 

otherwise unusable material is generally used as the starting material for fish-based fertilizers.” 

(TR Lines 267-69). This statement is explained below (TR Lines 93-109): 

Of the 124 fish-based fertilizers listed by OMRI, 76 percent contained at least some 

wild fish, 15 percent contained at least some farmed fish, and 27 percent contained 

fish where it was not possible to tell if a source was farmed or wild (OMRI, 2019a). 

Products in some cases used various combinations of wild, farmed, and unknown fish. 

Twelve percent of products contained at least some fish meal, 45 percent contained at 

least some fish hydrolysate, and 43 percent contained at least some fish solubles. One 

product contained both meal and solubles and was counted in both groups. 

It is worth noting that in Table 1, fish harvested for meal, oil, and solubles were not 

considered to be harvested solely for fertilizer production. The majority of fish-based 

fertilizers derived from the wet reduction process contain solubles—a material that is 

sometimes considered a byproduct of the process. A few products contain meal, but 

they do not also include fish oil; therefore, only a portion of the saleable fish biomass 

is utilized specifically for fertilizer and one cannot say that the fish were harvested 

exclusively for fertilizer use. An analogous example would be beef cows raised for 

steaks, ground meat, renderings and leather; those animals were not raised exclusively 

for any single one of those materials. Furthermore, only 2 percent of products 

contained fish meal that was derived from fish harvested specifically for wet 

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reduction. The remaining 10 percent of products containing fish meal are derived 

from fish waste that undergoes further processing. 

Table 1 in the TR states that of OMRI listed products, 43.5% are derived from market 

fish waste for human consumption (hereafter referred to as “waste”), 3.2% from 

bycatch and mortality, 31.5% from meal, oil, and solubles, 12.9% from market fish 

waste and bycatch/mortalities, 8.9% from market fish waste, meal, oil, and solubles, 

and 0% from fish sources specifically and exclusively for fertilizer. 

The TR is extensive and answers the questions posed by the CS. While the amount of fish 

harvested globally for fertilizer is not available due to limited data, the TR addresses the 

generally negative impacts of commercial fishing on many wild, native stocks. The TR states: 

Production of fish-based fertilizers could, to a small degree, drive demand for fish 

harvested for meal, oil, and solubles production. Fish-based fertilizers are unlikely to 

create demand for fish waste that drives fish harvesting rates for human consumption. 

The extent that harvesting wild, native fish for use as a fertilizer harms the 

environment is small compared to the primary uses of fish because of the difference in 

scale (Lines 319-23). 

The TR goes on to explain that: 

While none of the fish species known to be harvested for fish reduction purposes and 

which are incorporated into fish-based fertilizer products are threatened or 

endangered species (see Table 2), their population dynamics are not understood in 

many cases. It is also difficult to ascertain the effect of removing biomass, even from a 

sustainable fishery, considering that these species may be a food source for other 

species. Meal and oil fish can be critical to the function of entire ecosystems; for 

example, Pacific thread herring (Opisthonema libertate) and Pacific anchoveta 

(Cetengraulis mysticetus) are critical links in the Gulf of California, transferring energy 

through the food web and controlling the organization of these ecosystems 

(Hernandez-Padilla et al., 2017). (TR Lines 342-49) 

Regardless of the intended use, harvesting wild, native fish can contribute to 

biodiversity loss, habitat destruction, and loss of ecosystem services. (TR lines 327-28) 

The TR discusses some species used for meal/oil that have experienced documented large-scale 

population declines, though not always exclusively as a result of over-fishing. It addresses the 

effects of large-scale harvesting on fisheries and the broader ecosystems, yet it notes the 

relationship to fish used in fertilizer is scale-dependent. Harvest methods, location and timing, 

and gear are discussed. The use and impacts of farmed fish for fertilizers is also explained. 

Moreover, fertilizers made from waste of fish harvested for human consumption include species 

with well documented declines and collapses (TR lines 386-94). 

During the spring 2020 meeting, the Board solicited public comment on the following questions: 

1. Given the results of the TR indicating that there are no species of wild, native fish

harvested exclusively for use in LFPs, please provide feedback on any next steps the

subcommittee should take on this issue.

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2. The TR outlines the wet reduction process for fish meal, oil, and solubles and states that

solubles are a byproduct of meal (solid phase) and oil (liquid phase) production.

Because of the multiple products derived, it did not consider fertilizers using them to be

from fish harvested exclusively for fertilizer. Please comment.

3. Please provide any additional information you may have to help answer the TR

questions, particularly:

• During the Spring 2018 public meeting, the Crops Subcommittee asked if there

are manufacturers using exclusively wild-caught, native fish to

manufacture liquid fish fertilizers and learned that there are. Public testimony

suggested that other non-synthetic fish-based fertilizers, such as fishmeal, may

also be derived from wild fish harvested solely for fertilizer production. Is any

new information available about the impact of fish fertilizer manufacturing on

the sustainability and health of wild, native fish stocks harvested solely for

fertilizer production?

• Do different methods, locations, and/or frequencies of harvest pose different

levels of risk for wild, native stocks?

• Please provide examples of non-regulatory/practice-based approaches (e.g.

training, guidance) that should be considered.

A number of public commenters advised that since the TR indicates that no fish are harvested 

exclusively for fertilizer, the board should not continue work on this topic. Others stated that 

the discrepancy between the spring 2018 public comments and the TR results should be 

clarified. The subcommittee confirmed with the TR authors that they conducted additional 

research and analysis that revealed the multi-use purpose of fish harvested for wet reduction, 

namely for meal, oil, and solubles, information unavailable for the spring 2018 public comments. 

Commenters noted that organics should not degrade one ecosystem—in this case, the marine 

environment—to promote the health of another—agriculture. As one certifier stated, some 

producers think liquid fish products are already the result of waste only. Others expressed 

support for the precautionary principle. Several noted that even if fish are not harvested 

exclusively for fertilizer, having an outlet for meal and solubles provides some economic 

incentive to harvesting fish for meal for livestock feed and oil. 

It was suggested that the environmental impact should be considered in balance with all 

evaluation criteria. It was recommended that the NOP issue an instruction to Material Review 

Organizations to collect data on 1) the types of fish used, 2) the percentage that is waste, bycatch and mortalities, and meal, oil, and/or solubles, and 3) farmed, wild, or invasive. 

Fish-based fertilizers are widely used by organic farmers. The board heard from several 

producers of fish-based fertilizers stating that they share the board’s concern that fish should 

not be harvested exclusively for fertilizer and that they use waste material (heads, racks, skin, 

and viscera) left over from fish and shellfish processed for human food products. They 

explained that previously, these materials were dumped back into the ocean. Several harvesters 

noted that the waste they use comes from fish harvested in the U.S. Exclusive Economic Zone. 

They expressed concern over a lack of government oversight in some other regions. 

One commenter shared his experience as an organic inspector for a fish-based fertilizer: 

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Several years ago, I undertook an inspection of a liquid fish production facility for OMRI, 

part of the mandatory inspection of facilities producing high nitrogen liquid fertilizer 

products that is now mandated under NOP. The inspection took place in a region that I 

know has been heavily, negatively impacted by years of unregulated or poorly regulated 

commercial fishing, namely Mexico’s Sea of Cortez. While I previously assumed that 

most if not all fish fertilizer products were generated from bycatch or processing waste 

from canneries, while performing the inspection I was deeply shocked, surprised and 

saddened to learn that the operation was harvesting fish stocks solely for the purpose of 

producing fish emulsion and fish meal. 

The commenter further states: 

I believe the TR actually does a disservice by attempting to separate fish stocks that are 

harvested for fishmeal from those that are harvested for fish solubles. Either way, we 

are talking about mining the oceans for agricultural nutrients, whether they are fish 

solubles or fish meal used as fertilizer or feed, at a time when there are not enough 

resources left to support healthy marine ecosystems, not to mention the many poor 

people who depend on these fisheries to survive. 

A number of commenters expressed support for allowing fish-based fertilizers from human 

consumption waste only. 

Proposal: 

In its initial discussions, the Subcommittee considered how any negative environmental impacts 

associated with harvesting wild, native fish for fertilizer might be addressed in the regulations. 

There is no intention to exclude the use of farmed fish or invasive species that are harvested to 

protect native ecosystems, though the TR explains that there are currently few such products on 

the market (TR lines 662-87). The Subcommittee explored the merits of an annotation to 

Section 205.601(j)(8) prohibiting the use of wild, native fish harvested solely for the 

manufacture of those materials, as well as listing wild, native fish harvested solely for fertilizer 

at Section 205.602. While the Subcommittee initially proposed that a prohibition on 205.602 

alone would suffice, public comment suggested that an annotation should also be listed at 

205.601(j)(8). The Subcommittee consulted with the Organic Materials Review Institute (OMRI) 

and found that the overwhelming majority of fish fertilizer products they list are synthetic. In 

discussion with the National Organic Program and review of OFPA section 6517(c), it was 

determined that the best course of action would be a single listing at 205.601(j)(8). The 

proposed definitions were crafted based on language in the TR. The definition of bycatch, in 

particular, is a fusion of federal definitions and wording from the TR. 

As noted above, the TR Table 1 lists the source of fish for OMRI listed products, and a total of 

60% are from a combination of waste and/or bycatch/mortalities. Of the remaining products, 

31.5% are from meal, oil, and solubles from the wet reduction process, and 9% are a 

combination of waste and meal, oil, and solubles. It is important to note that meal, oil, and/or 

solubles can be derived from fish waste. The TR explains that “some meal, oil, and solubles are 

produced from fish originally harvested for other purposes” (TR pg. 3, footnote 3). In other 

words, “waste from fish harvested for other purposes is sometimes diverted into fish meal 

production” (TR pg. 3, footnote 3). Additionally, “the majority of fish meal used in fish-based 

fertilizers is produced from fish waste, but a minor amount (2 percent) is produced from fish 

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caught specifically for reduction purposes (fish meal and fish oil, with fish solubles as a 

byproduct or coproduct)” (TR lines 337-39). The TR goes on to explain that “fish solubles used in 

fish-based fertilizers on the other hand most often come from fish harvested specifically for 

meal and oil production” (TR lines 339-40). Finally, “while 55 percent of fish-based fertilizers 

currently approved by OMRI contain fish meal or solubles, the remaining 45 percent contain 

hydrolysates, most of which are produced from fish scraps of wild fish, harvested for human 

consumption” (TR lines 384-86). It is unclear from the TR how many of the OMRI-listed products 

in Table 1 derived only from meal, oil and solubles (31.5% of the total) are sourced from fish 

harvested exclusively for wet reduction (see footnote below for a breakdown of products by 

source). 

The question before the subcommittee is whether fertilizer products containing fish harvested 

exclusively for the wet reduction process should be used. The wet reduction process harvests 

fish for meal, oil, and solubles. After harvest, the fish are cooked and pressed. The solids and 

liquids are separated. The solids become fish “meal”. The liquids can be further separated into 

“oil” and “solubles”. Solubles are then evaporated and concentrated. 

Fish-based fertilizers occur in liquid and dry forms. Dry forms are typically composed of 

the same materials as liquid products, though some dry products contain fish meal, 

which is not typically found in liquid formulations. Ingredients are usually in one of the 

following forms: solubles, hydrolysates, or meals. (TR lines 42-45) 

The Subcommittee agrees with public commenters that fertilizer derived from fish harvested for 

the wet reduction process, while not harvested exclusively for fertilizer, is not in keeping with 

organic principles as both the meal and solubles are used in dry and liquid fertilizers. The 

Subcommittee also recognizes the importance of fish-based fertilizers for organic producers. 

Consequently, this proposal recommends an annotation that does not prohibit fish fertilizers 

but instead requires that they be derived from waste from human use or bycatch/mortalities. 

The majority of OMRI-listed fish-based fertilizers already meet these criteria. 

Public comment questioned how such an annotation could be verified. Because this annotation 

relates to easily identified ingredients—fish hydrolysates, meal, and/or solubles —an affidavit 

from producers attesting that the fish ingredients in their products are sourced from waste, 

bycatch/mortalities, and/or invasive species would be sufficient. Either the product does or 

does not contain fish products sourced from waste, bycatch, and/or invasive species. 

The Subcommittee contacted the TR authors to ascertain the number of fertilizer products 

containing fish meal, oil, and/or solubles from fish harvested exclusively for the production of 

meal, oil, and solubles versus fertilizers containing meal, oil, and/or solubles derived from fish 

waste and/or bycatch. The majority of LFPs are derived from waste and/or bycatch/mortalities1

. 

1 The following data is from a combination of dry products (27) and liquid products (97), for a total of 124 

products altogether. 

For meal-based products, 11 of the 15 were derived from waste, and 4 were derived from fish harvested for 

meal/oil/solubles. 

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As organic production increases, the use of LFPs will rise. This proposal prevents the use and 

expansion of LFPs from fish harvested exclusively for meal, oil, and solubles, regardless of their 

portion of market demand relative to other uses for those products. 

The TR notes that “In general, commercial fishing has been detrimental to the sustainability and 

health of many wild, native fish stocks” (lines 290-91). While not specific to those species 

harvested for meal, oil, and solubles, the TR provides an overview of global fisheries: 

Globally, collapses in large predatory fish now occur in all large marine ecosystems, 

primarily due to mismanagement and overfishing (Worm et al., 2007; Costello, Gaines, 

& Lynham, 2008). Except for the Northwest and Northeast Pacific regions, harvests in 

temperate areas have declined for several years (FAO, 2018), indicating reduced 

populations of fish biomass, generally. Models have indicated that by 2050, overfishing 

and habitat degradation will have depleted not only the oceanic shelves, but also deep 

slopes, canyons, seamounts, and deep ocean ridges of “bottom fish” such as orange 

roughy, Chilean seabass, and hagfish (Pauly et al., 2003; Worm et al., 2006). In 2015, the 

FAO considered 33.1% of fish stocks to be harvested at biologically unsustainable levels 

(2018). (TR lines 299-306) 

Specific to fish harvested for meal, oil, and soluble production, the TR provides the following 

details: 

Of the primary meal/oil fish that are likely to be used in fish-based fertilizers, three 

species have documented large-scale population declines (collapses) within the last 50 

years or so (Table 2). In some cases, localized populations have undergone severe 

declines, but these declines are not always captured within FAO fact sheets and 

International Union for Conservation of Nature (IUCN) data. For example, the FAO’s fact 

sheet for Indian oil sardine (Sardinella longiceps) does not capture collapses and 

declines shown by Kripa, et al. (2018). Pacific anchoveta experienced collapse in 1947 

around the Gulf of Nicoya (Bayliff, 1969), but this is both outside of the data range, and 

possibly too localized to show up in FAO fact sheets and IUCN data. These declines are 

not always due exclusively to overfishing, but also due to climate, ocean currents, and 

For solubles-based products, 4 of the 54 were derived from waste, 2 were derived from waste and from 

bycatch/mortalities, 36 were derived from fish harvested for meal/oil solubles, and 11 were derived from 

waste and from fish harvested for meal/oil solubles. 

None of the hydrolysates-based products (56) were derived from fish harvested for meal/oil/solubles. 

Therefore, 40 of the 124 are derived from fish harvested for meal/oil solubles, and 11 were derived from 

waste and from fish harvested for meal/oil solubles for a total of 51 of 124 products. Note that this 

proposal only deals with liquid fertilizers. Of the liquid products, 48 would meet the proposed annotation 

because they are hydrolysates-based (are all which are derived from market waste). Of the 48 solublesbased liquid fertilizers, 4 are derived from waste, 2 are from waste and bycatch/mortalities, 11 are from a 

combination of waste and from fish harvested for meal/oil solubles, and 31 are from fish harvested for 

meal/oil solubles. The 1 meal-based liquid fertilizer is derived from waste from market fish. 

Finally, it is important to emphasize that this information cannot be assumed to be without error, though 

every attempt was made to assess the products as accurately as possible. The subcommittee thanks the TR 

authors for the additional detail they provided. 

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food web changes—though the exact mechanisms are not always well understood 

(Chavez, Bertrand, Guevara-Carrasco, Soler, & Csirke, 2008; Bayliff, 1969; Punt, et al., 

2016). 

Perhaps the most important fish with regard to meal, oil, and solubles production is the 

Peruvian anchoveta (Engraulis ringens). Up to one third of the raw material for fishmeal 

comes from this fish (FAO, 2007), which is used for animal feed (both terrestrial and 

aquatic) and fertilizer (Pauly, et al., 2003). According to the FAO, Peruvian anchoveta 

have been exploited more than any other fish in world history (FAO, 2019a). In 2017, 

fishers were only able to capture 46 percent of the allotted quota (1.49 MMT), due to a 

population composed largely of juvenile fish (Fraser, 2018). According to the IUCN, the 

Peruvian anchoveta population trend is unknown, and this fish has undergone 

population collapse in the past due to overfishing and climatic conditions (IUCN, 2019; 

FAO, 2019a). 

Likewise, Pacific sardines (Sardinops caeruleus) also experienced a population collapse in 

1967 (FAO, 2019h). In 2015, the harvest was just 7 percent of what it was in 2009. The 

most recent decline in Pacific sardines has been attributed to unfavorable 

environmental conditions (Punt et al., 2016) and intense fishing pressure (Williams, 

2014). The population decline of the Pacific sardine has affected populations of brown 

pelicans, marbled murrelets, Brandt’s cormorants, and sea lions, which rely on the 

sardines as a food source (Williams, 2014; Spratt, 2016). NOAA, however, does not 

consider the Pacific sardine overfished as of 2017 (NOAA, 2019c). (TR lines 355-81) 

Although fish harvested for human consumption has ecological impacts as well, the parts used 

in fertilizer are considered waste products that would not otherwise have a use. Since the 

majority of OMRI-listed fertilizers containing fish are sourced from a combination of fish waste 

and/or bycatch, ample alternatives exist to LFPs that are derived from fish harvested for meal, 

oil, and solubles. For the spring 2020 meeting, the board received a letter signed by “three 

companies ... compris[ing] the majority of the domestically manufactured Fish Protein 

Hydrolysate used in organic farming in the U.S.”, and they wrote to explain that “all the fish we 

use to make Fish Protein Hydrolysate comes from the byproduct of fish processing for human 

consumption”. Furthermore, in its 2016 recommendation to allow squid in fertilizers, the board 

voted to limit the listing to squid byproducts. The limitation to byproducts reflected the board’s 

desire to ensure that squid are not harvested for fertilizer and that materials used in organic 

production contain only waste products left over after processing for human consumption. 

Conclusion: 

Harvesting wild native fish for use in meal, oil, and solubles is not essential for organic farming 

as alternative products using fish waste, bycatch, or even invasive species exist. As stated in 

public comment, the majority of fish fertilizers used by U.S. farmers comes from fish byproducts. 

Organic farmers often assume these products come from byproducts, and several large 

producers have expressed their support for the Board’s work on this topic. To avoid 

contributing to population declines of fish and the associated species within the ecosystems 

dependent on them, LFPs made from fish harvested for meal, oil, and solubles are not 

compatible with a system of sustainable agriculture. 

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Vote in Subcommittee 

Motion to amend Section 205.601(j)(8) as follows: 

(8) Liquid fish products—sourced only from fish waste, bycatch, or invasive species–can be pH

adjusted with sulfuric, citric or phosphoric acid. The amount of acid used shall not exceed the

minimum needed to lower the pH to 3.5.

Motion by: Emily Oakley 

Seconded by: Dave Mortenson 

Yes: 8 No: 0 Abstain: 0 Absent: 0 Recuse: 0 

Motion to add the following definitions to Section 205.2 Terms defined: 

Fish waste. Waste or byproduct left over after market fish are processed for human 

consumption. 

Bycatch. Incidental or discarded catch that have no economic value, fish that must be discarded 

because of management regulations, or fish that are killed by fishing gear (mortality). 

Motion by: Emily Oakley 

Seconded by: Steve Ela 

Yes: 8 No: 0 Abstain:0 Absent: 0 Recuse: 0 

Approved by Jesse Buie, Subcommittee Chair to transmit to NOSB, July 21, 2020 

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National Organic Standards Board 

Crops Subcommittee 

Petitioned Material Proposal 

Sodium Carbonate Lignin 

August 4, 2020 

Summary of Petition: 

Sodium carbonate lignin has been petitioned for use in organic crop production through addition to the 

National List at 205.601(j)(4) of "lignins" as a dust suppressant. Lignin sulfonate, another type of lignin, 

is currently listed at 205.601(j)(4) for use as a chelating agent and dust suppressant. The petitioned 

material results from a paper pulping process that uses sodium carbonate and sodium hydroxide to 

extract lignin. Lignins found in plant cell walls are amorphous, complex biopolymers. Lignins make up 

20-30 percent of plant cell walls, 30 percent of the total mass in softwood, 20-25 percent of the total

mass in hardwoods and a smaller percentage of the total mass of herbaceous species. Commercial

lignins are obtained as byproducts of the bioethanol and paper pulping industries.

Sodium carbonate lignin has a variety of potential uses. Lignins are used for binding and are added in 

fertilizer formulations to improve granule formation by binding extrusion granules. They also prevent 

fertilizer caking during storage. Lignins are also used for dust suppression. They are useful as binders in 

fertilizer and feed formulation because improving the quality of the pelletizing or granulation of these 

materials is a well-known measure for dust suppression. Adding binders such as lignin increases 

fertilizer granule strength, thereby reducing the formation of dust . Lignins have also been sprayed on 

roads for dust control. 

Lignins are used to chelate micronutrients in fertilizer formulations to form more stable, yet still soluble, 

complexes that improve plant micronutrient availability. 

Summary of Review: 

At this time there has not been any public comments on sodium carbonate lignin, but lignin sulfonate 

has been reviewed and public comments on this product have been positive for relisting during sunset 

review. A survey of regulations for organic production from a number of countries and international 

organizations indicates that the use of sodium carbonate lignin is not generally permitted while lignin 

sulfonate is approved by many of the international organizations. 

Category 1: Classification 

1. For CROP use: Is the substance Non-synthetic or X Synthetic?

Is the substance formulated or manufactured by a process that chemically changes a substance

extracted from naturally occurring plant, animal, or mineral sources? [OFPA §6502(21)] If so,

describe, using NOP 5033-1 as a guide.

The petition describes the process used to manufacture sodium carbonate lignin both as soda

ash pulping and soda pulping. Wood chips are subjected to a solution of either sodium

carbonate or a combination of sodium carbonate and sodium hydroxide and coked in steam

under pressure for 15 minutes. The cooked wood chips are then mechanically pressed to

separate the spent cooking liquor which is then evaporated to a dry powder. Lignin is a natural

product that is chemically altered to become synthetic.

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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?

The petitioner is requesting that sodium carbonated lignin to 7 CFR 205.601(j)(4) as a synthetic

substance allowed for use in organic crop production as a plant and soil amendment for dust

suppression in addition to lignin sulfonate.

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)]

Soil stabilization with sulfur-free lignin has been studied and application of the lignin was found

to slightly decrease soil pH, but was still comparable to the pH of natural soil. Different types

of lignin phenols can be inhibitory to some fungal species, but they may also stimulate microbial

activity depending on the amount of lignin applied. The use of the petitioned substance for dust

control has the potential to increase soil aggregate size and water retention, which some

researchers suggest may be ecologically beneficial.

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)]

Environmental studies over the last 30 years have shown lignin sulfonates to be nontoxic at 

concentrations above those used (TR 621). Lignins have been shown to be an important 

precursor in the formation of humic substances (TR 601) and they can increase soil organic 

carbon and total nitrogen. Lignins are toxic in wastewater streams from the paper pulping 

process and can be toxic to aquatic organisms. Using lignin sulfonates in organic farming could 

benefit the environment by removing them from the paper manufacturing process waste 

stream. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or

disposal of such substance? [§6518(m)(3)]

There are four pulping processes that make up the majority of production methods. As one

study reported, the soda process has the lowest potential environmental impact as measured by

a waste reduction algorithm developed by the EPA's National Risk Management Research

Laboratory. None of the literature reviewed by the 2020 Technical Review suggested that the

use of lignins as petitioned would result in environmental contamination of organic systems.

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4. Discuss the effect of the substance on human health. [§6517(c)(1)(A)(i); §6517(c)(2)(A)(i);

§6518(m)(4)].

In the Technical Review performed in 2020 a review of environmental studies of the last 30 

years found that lignin sulfonates are nontoxic at the concentration used. In fact, it was stated 

that worker safety is improved with the use of lignins as dust suppressants in preventing dust 

inhalation when workers dispense fertilizers, and also obviates the need for wearing respirators. 

The U.S. EPA issued an exemption from the requirement of a tolerance for lignin sulfonates 

when they are used as inert ingredients pre- and post-harvest in agricultural product and the 

same would be expected for lignin carbonates. 

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 use of the petitioned substance is for dust control in the context of a plant or soil

amendment and as such, is applied to the soil at relatively low rates. As the Technical Report

stated, this consideration with the potential effects of lignin to increase soil aggregate size and

water retention and enhance microbial activity, suggest that its use as petitioned is likely to be

benign and may even be ecologically beneficial.

6. Are there any adverse impacts on biodiversity? (§205.200)

At the rates this substance is applied, no adverse impacts on biodiversity are expected.

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)]

OMRI has 11 products listed in the category of "Dust Suppressants" and another 29 in the

category of "Lignin Sulfonates." Many of these products contain wax emulsions or combinations

of oil and wax emulsions. Also vegetable oils, magnesium or calcium chloride solutions, glycerin

and natural fatty acids are also used. Their effectiveness over time may decrease as oils

volatilize or become adsorbed in fertilizer particles and waxes and oils have limited binding

capacity. Other nonsynthetic fibrous materials have been suggested and include wood flour,

peat moss, compost, manure, cotton, straw and clay. Dust suppression for roads can also

include management practices such as maintaining vegetative cover in non-traffic areas,

mulching, application of stone or gravel to disturbed roads and air current barriers such as trees.

In reviewing the petition, the Crop Subcommittee feels that there is no need to add another

synthetic lignin product for dust suppression since numerous lignin alternatives already are

available for use.

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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, sodium carbonate lignin, when used in fertilizer as a dust suppressant, allows finer particles

to be produced. These smaller particles allow faster breakdown and with moisture, more

immediate nutrients are available to plant life. Additionally, removing lignins from the paper

pulping industry and repurposing them to organic farming use prevents a source of lignin

contamination in discharge in wastewater. However, given that there are viable alternatives

already on the National List, the Crops Subcommittee feels that there is no need to add another

synthetic lignin product for dust suppression.

Classification Motion: 

Motion to classify sodium carbonate lignin as synthetic 

Motion by: Rick Greenwood 

Seconded by: Dave Mortensen 

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

National List Motion: 

Motion to add sodium carbonate lignin at 205.601 (j)(4) 

Motion by: Rick Greenwood 

Seconded by: Steve Ela 

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

Approved by Jesse Buie, Crop Subcommittee Chair, to transmit to NOP August 4, 2020 

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Sunset 2022 

Meeting 2 - Review 

Crops Substances §205.601, §205.602 

October 2020 

Introduction 

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

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

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

National List for use in organic crop production that must be reviewed by the NOSB and renewed by the 

USDA before their sunset dates. This document provides the substance’s current status on the National 

List, use description, references to past technical reports, past NOSB actions, and regulatory history, as 

applicable. If a new technical report has been requested for a substance, this is noted in this list. To see 

if any new technical report is available, please check for updates under the substance name in the 

Petitioned Substances Database. 

Request for Comments 

Written public comments will be accepted through October 1, 2020 via www.regulations.gov. 

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

NOSB Proposals and Discussion Documents October 2020 25 of 173
 

Sunset 2022 

Meeting 2 - Review 

Crops Substances §205.601, §205.602 

October 2020 

Reference: 7 CFR §205.601 Synthetic substances allowed for use in organic crop production. 

Soap-based algicide/demossers 

Ammonium carbonate 

Soaps, insecticidal 

Vitamin D3 

Aquatic plant extracts 

Lignin sulfonate 

Sodium silicate 

EPA List 4 - Inerts of Minimal Concern 

205.602 Prohibited nonsynthetic substances 

Arsenic 

Strychnine 

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Soap -based algicide/demossers 

Reference: 205.601(a)(7) - As algicide, disinfectants, and sanitizer, including irrigation system cleaning 

systems. 

Technical Report(s): 1996 TAP; 2015 TR 

Petition(s): N/A 

Past NOSB Actions: Actions: 09/1996 NOSB recommendation; 11/2005 NOSB sunset recommendation; 

04/2011 NOSB sunset recommendation; 10/2015 NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

As an approved algicide/demossers, synthetic soap salts are permitted for the control of algae and mosses 

in and around production areas, including walkways, greenhouse surfaces and irrigation systems. 

Manufacture: 

A variety of preparatory methods are employed depending on the desired soap salt composition for a 

particular herbicide/algicide formulation. Potassium salts of fatty acids are produced through a process 

known as saponification, whereby aqueous potassium hydroxide is added to fatty acids found in animal fats 

and plants oils. Sources of potassium soap salts are prepared through hydrolysis of triglycerides using 

water under high pressure and temperature. A carbonate or hydroxide salt of an alkali metal (potassium or 

sodium) traps the free fatty acid into a soap salt. Commonly used fats (triglycerides) include coconut oil, 

sunflower oil, palm oil, tallow, and olive oil. Soaps are mixtures of fatty acid salts having a variety of carbon 

chain lengths and generally do not consist exclusively of one soap salt compound. 

International acceptance: 

The Canadian General Standards Board, the European Union, Codex Alimentarius Commission, the 

Japanese Ministry of Agriculture, Forestry and Fisheries, and the International Federation of Organic 

Agriculture Movements (IFOAM) all allow soap-based compounds for the purposes listed for this product. 

Environmental issues and human health: 

Soap salts essentially behave as the carboxylate anions of fatty acids when released into the environment. 

In general, potassium and ammonium salts of fatty acids decompose rapidly and do not accumulate or 

persist in the environment. Biodegradation is expected to be an important fate process and field tests 

show half-lives at less than one day for these salts. US EPA has waived all generic mammalian toxicity data 

requirements for potassium and ammonium soap salts due to the lack of effects at high doses in the 

available toxicity literature. Potassium salts of fatty acids are generally recognized as safe (GRAS) by the 

FDA. Also, studies have shown that soap salts are practically non-toxic to honeybees. 

The Crops Subcommittee voted to delist soap-based algicide/demossers in 2015 because it was thought 

that they were no longer used in organic crop production and it was not necessary to keep them on the 

National List. However, public comments indicated that these materials were still being used by some 

producers. Based on public comment they were not removed. Public comments in 2020 were supportive 

of continued listing of these products and indicated that they are still being used in organic farming. 

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Subcommittee Vote: 

Motion to remove soap based algicide/demossers from §205.601(a)(7) of the National List based on the 

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

Motion by: Rick Greenwood 

Seconded by: Steve Ela 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

Ammonium carbonate 

Reference: 205.601(e) As insecticides (including acaricides or mite control). (1) ammonium carbonate —for 

use as bait in insect traps only, no direct contact with crop or soil. 

Technical Report: 1995 TAP (Ammonium bicarbonate) 

Petition(s): N/A 

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

NOSB sunset recommendation; 10/2015 NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Used as bait in insect traps, not intended for direct contact with the crop or soil. Ammonium carbonate is 

used in small quantities as an attractant in traps. In some cases, ammonium carbonate is used alone and in 

others, as a mixture with yeast to enhance its chemical attraction to insects. It is marketed for the control 

of a range of fly types problematic in livestock as well as fruit and nut production. The main alternatives are 

manure management and enhancement of predators and parasitoids, but its use to trap adult flies 

complements the use of other methods that control egg-laying and immature stages. While ammonium 

carbonate is used as a fly bait, we were able to find little published literature on the effects of the bait on 

other insect species. Natural alternatives include natural attractants. Other alternative materials include 

other ammonia-releasing chemicals. Practices that would make its use unnecessary include a good organic 

environment and enhancement of predators and parasitoids. 

Manufacture: 

Ammonium carbonate is produced by combining carbon dioxide and aqueous ammonia. Ammonia is 

volatile and toxic and a known irritant to eyes and nose. It is incompatible with strong acids, nitrates, nickel, 

copper. However, the current annotation makes interaction unlikely. At room and field temperatures, 

ammonium bicarbonate will spontaneously decompose into ammonium bicarbonate and ammonia which 

further decomposes to carbon dioxide, water and another molecule of ammonia. 

International Acceptance: 

Canadian General Standards Board Permitted Substances List - permitted as an attractant in insect traps. 

Codex Alimentarius Commission - not listed 

European Economic Community (EEC) Council Regulations - not listed 

International Federation of Organic Agriculture Movements (IFOAM) - not listed 

Japan Agricultural Standard for Organic Production - not listed 

Environmental Issues: 

The intended use in crop production is as a bait that would not come in contact with plants or soil. A small 

amount of ammonium carbonate is used alone or in a mixture with yeast. The ambient temperature during 

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use would result in ammonium carbonate volatilizing, releasing ammonia and carbon dioxide as gases. 

Given the small amount of ammonium carbonate used, the impact of its volatilization would be small. We 

were unable to find reports of non-target effects on other insect species. Such information would aid in our 

review of this material. 

Discussion: 

During the April 2015 public comment period, most respondents supported relisting including a number of 

respondents who voiced strong opposition to other insect pest management chemicals up for relisting. The 

past two sunset reviews of ammonium carbonate resulted in limited stakeholder input attesting to the 

efficacy and need of the material. During the period leading up to the April 2020 NOSB meeting information 

was sought on the following questions: 1) to what extent is ammonium carbonate used as a bait for 

trapping and thereby managing fly and other insect pest populations? 2) How effective is the practice for 

managing flies? and 3) to what extent is the population behavior of beneficial insects altered by the 

ammonium carbonate bait? From the considerable public comment received on ammonium carbonate, it 

is clear it is being used by organic farmers, particularly those with poultry and livestock herds and by fruit 

and nut growers where cherry fruit fly and spotted wing drosophila are issues. Several stakeholders 

indicated the use of ammonium carbonate as an attractant in insect baits aided the management of fly and 

other pest insect populations. There were no calls for delisting the compound given its widespread use in 

organic poultry and livestock production systems. While data on non-target effects on beneficial insects is 

lacking, there is little data to support challenging the benign effects of this compound when used as a bait 

for pest insect management in organic production systems. It is clear that the use of baited insect traps is 

consistent with an integrated approach that would also include controlling flies through manure 

management and enhancement of predator and parasitoid populations. 

Subcommittee Vote: 

Motion to remove ammonium carbonate from §205.601 of the National List based on the following criteria 

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

Motion by: Dave Mortensen 

Seconded by: Emily Oakley 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

Soaps, insecticidal 

Reference: 205.601(e)(8) - As insecticides (including acaricides or mite control). 

Technical Report: 1994 TAP; 2020 TR 

Petition(s): N/A 

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

NOSB sunset recommendation; 10/2015 NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Insecticidal soaps are used for control of soft bodied insects and hard bodied insects in the larval stage on 

organic crops. 

Manufacture: 

A reaction of an alkali such as sodium or potassium hydroxide on natural fatty acids (from both animal and 

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plant sources) is used to prepare insecticidal soaps. The fats, such as laurate, myristate, oleate, and 

ricinoleate are further processed to create a blend of selected fatty-acid chain lengths. The cation for soap 

molecules is determined by the base used in its production. Potassium soaps are derived from the 

treatment of fatty acids with potassium hydroxide while ammonium soaps are produced by saponification 

with ammonium hydroxide. 

International acceptance: 

European Economic Community (EEC) lists potassium soaps as an insecticide with applications "from 

traditional us in organic farming." Japan Agricultural Standard (JAS) lists soaps as agents for cleaning or 

disinfecting livestock and the Canadian General Standards Board Permitted Substances List includes 

ammonium soaps as a permitted substance. IFOAM lists potassium soaps as an equipment cleanser and 

equipment disinfectant. 

Environmental issues and human health: 

The toxicological profile of the substances differs based on the environment in which it is located. 

Insecticidal soaps are widely regarded as having low toxicity to terrestrial organisms, like mammals and 

avian animals. Insecticidal soaps are rapidly biodegradable in the environment and the half-life is estimated 

to be less than one day. Microbial organisms rapidly degrade fatty acids in soils. Potassium salts are highly 

toxic to aquatic invertebrates and slightly toxic to both cold water and warm water fish species. Due to this 

potential toxicity to aquatic environments, insecticidal soap product labels stipulate that the products are 

not intended for application to aquatic systems including ponds and streams. EPA has given these 

insecticides the lowest Toxicity Category IV (indicating the lowest level of toxicity). Potassium salts of fatty 

acids used on food and feed crops have been exempted from the requirement of a tolerance (or maximum 

residue limit) for all raw agricultural commodities since 1982. They are also generally recognized as safe 

(GRAS) by the FDA. Recent studies (2018) have shown insecticidal soaps to be non-toxic to desirable insects 

such as lady bugs and the coccinellid beetle. A recent technical review (2020) reports that "there is little to 

suggest that insecticidal soaps pose a threat to the environment when used as approved." In fact, the 

report goes on to state that because of the low toxicity, even if it is used improperly, environmental impact 

would be minimal. 

Alternatives: 

Alternatives include cultural pest control methods or oils, botanicals, or biological controls (depending on 

species). A variety of essential oils have been used as well as pyrethrum, however, horticultural oils and 

pyrethrum are easily degraded under common conditions like UV-radiation. Moreover, differences in the 

mode of action and in their targets (hard-bodied vs. soft-bodied) of essential oils and pyrethrum make one 

a poor substitute for the other. 

In the previous Sunset review in 2015 there was overwhelming support for the continued listing of this 

material. Public comments stated that this material remains a necessary tool in organic crop production 

and in fact has increased in use due to the growth of organic production. Public comment stated that these 

oils are allowed for use world-wide by most organic certifying bodies. The 2020 public comments for this 

product again showed overwhelming support for the continued listing of insecticidal soaps and that they 

were also in wide use. 

Subcommittee Vote: 

Motion to remove insecticidal soaps from §205.601(E)(8) of the National List based on the following criteria 

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

Motion by: Rick Greenwood 

Seconded by: Dave Mortensen 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

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Vitamin D3 

Reference: 205.601(g) - as rodenticides. 

Technical Report: 1995 TAP; 2011 TR 

Petition(s): N/A 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 NOSB sunset recommendation; 04/2011 

NOSB sunset recommendation; 10/2015 NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Vitamin D3 (cholecalciferol) is used to fortify food and aids in the growth and maintenance of bones, 

typically found in milk and cereals. Forms of vitamin D are also found in margarine and infant formula. In 

this listing, vitamin D3 is used as a synthetic rodenticide both in gel and pellet baits. Vitamin D3 kills 

gophers, mice, rats and other rodents by causing an excessive, highly elevated level of calcium which results 

in hypercalcemia and mineralization of major organs (including kidney failure) leading to death. 

Manufacture: 

The 2011 TR states: The commercial manufacture of vitamin D3 utilizes cholesterol obtained by organic 

solvent extraction of animal skins (pig, sheep, or cow) and extensive purification (Norman, 2000). Typically, 

cholesterol is extracted from the lanolin of sheep wool and converted to 7-dehyrdocholesterol after a 

process of chemical synthesis that involves eighteen steps (Norman, 2000). The crystalline 7-

dehyrdocholesterol is then dissolved in an organic solvent and irradiated with UV light. This process causes 

a photochemical transformation of 7-dehyrdocholesterol into cholecalciferol that is similar to the natural 

process that occurs in the skin of humans. It is then purified and crystallized further before being 

formulated for use (Norman, 185 2000). Details of the manufacturing process are subject to several patents 

(Norman, 2000) and are not publicly available. 

Since the formulations contain .075% of cholecalciferol, with the remainder “inerts,” it is unknown what the 

other ingredients are, although much of it will be attractive food stuffs to the rodents. 

International Acceptance: 

The Canadian General Standards Board Permitted Substances List has this annotation on vitamin D3 

(cholecalciferol) “if used outdoors and inside greenhouses for rodent control when methods described in 

5.6.1 of CAN/CGSB-32.310 have failed. Prohibited inside on-farm food processing and food storage 

facilities.” 

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

Organically Produced Foods (GL 32-1999), has an allowance for rodenticides with this caveat “Products for 

pest control in livestock buildings and installations. Need recognized by certification body or authority”. 

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

rodenticides are only to be used in traps. The Japan Agricultural Standard (JAS) for Organic Production and 

the International Federation of Organic Agriculture Movements (IFOAM) do not list this product, nor have 

any specific requirements for rodenticides. 

Environmental Issues: 

According to the TR, vitamin D3 is not expected to mobilize in soil and its bioconcentration in aquatic life is 

expected to be very low. Because of its insolubility in water, its use is unlikely to cause contamination to 

ground or surface waters. Since its use is restricted by the Environmental Protection Agency to bait 

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stations, the risk of accidental poisonings of non-target species has been addressed. Vitamin D3 is of low 

toxicity in birds, unlike the more widely used anti-coagulant rodent baits not approved for organic 

production. 

Subcommittee Review: 

A range of stakeholders provided public comment on vitamin D3 as a rodenticide at the April 2020 NOSB 

public meeting, and with almost no exception, the community has expressed its support for the material’s 

continued listing for permitted use in organic production. Most of the comments addressed the issue of 

non-target species toxicity. 

Since birds of prey can be of great use in controlling rodents on the farm, the use of vitamin D3 is preferred 

due to its very low risk to bird populations. Birds have a much lower body weight and the consumption of 

just one or two rodents who had consumed an anticoagulant bait could be detrimental to the bird’s health 

or cause death. Using a rodenticide that does not harm the predator population is an ecosystem friendly 

approach to controlling rodent populations. While non-target mammals could consume rodents that are ill 

from consuming vitamin D3, it would take many of these rodents to cause harm up the food chain. There 

are system-based methods that can be used to control rodent populations, such as improving structures to 

prevent their entry, as well as keeping food/water and harborage to a minimum. However, there are times 

when the use of a toxic bait is necessary to lessen the rodent population so that other system-based 

approaches can then take over. 

Vitamin D3 as a rodenticide continues to be reported in wide use by many organic stakeholders, particularly 

in situations where environmental factors and built structures create conditions conducive to rodent 

infestations. There has been some critique of its efficacy, but nearly no grower or certifier expressed 

opposition to its continued listing as an essential substance for the organic toolkit. Most stakeholders 

report anecdotal findings that vitamin D3 has low toxicity to birds and to other non-target species, 

particularly as compared to other rodenticides. Notably, one non-profit stakeholder organization has 

suggested via public comment that vitamin D3 can lead to painful death in rodents and could be replaced 

with other substances. Given the widespread support from stakeholders for keeping this material available 

to organic growers, the Crops Subcommittee recommends relisting of this material. 

Subcommittee Vote: 

Motion to remove vitamin D3 from §205.601 of the National List based on the following criteria in the 

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

Motion by: Wood Turner 

Seconded by: Jerry D’Amore 

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

Aquatic plant extracts 

Reference: 205.601 (j) As plant or soil amendments. (1) Aquatic plant extracts (other than hydrolyzed) – 

Extraction process is limited to the use of potassium hydroxide or sodium hydroxide; solvent amount is 

limited to that amount necessary for extraction. 

Technical Report: 2006 TR; 2016 TR 

Petition(s): N/A 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 04/2006 sunset recommendation; 10/2010 NOSB 

sunset recommendation; 10/2015 NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Plant extracts are composed of chemicals naturally found in aquatic plants (TR 2006 line 19), namely marine 

plants (also called seaweed). Aquatic plant extracts are used as foliar fertilizers or as soil conditioners. 

They also are used in combinations as a foliar/soil feed or transplant solution and seed treatment. The 

material is absorbed into the plant and acts as a growth promoter (TR 2006 lines 63-6). Aquatic plants 

contain proteins, lipids, sugars, amino acids, nutrients, vitamins, plant hormones, and other biochemicals 

(TR 2006 lines 26-7). Aquatic plants contain a wide range of naturally occurring plant nutrients and trace 

minerals essential to plant growth, health, and productivity (TR 2006 lines 41-42). Cytokinins, a class of 

plant hormones present in aquatic plant extracts, have been reported to have beneficial effects on crops, 

including increase in number or size of fruits or seed heads, synchronization of flowering within a field, and 

delayed decay of mature plants (TR 2006 lines 46-8). 

Manufacture: 

Seaweeds are classified into three broad groups based on pigmentation: brown, red, and green; 

respectively, Phaeophyceae, Rhodophyceae and Chlorophyceae (TR 2016 lines 103-4), and all three classes 

are used in aquatic plant extracts. Seaweeds are also called macro-algae, distinguishing them from microalgae (Cyanophyceae) which are microscopic in size and often unicellular (TR 2016 lines 108-110). 

Seaweeds used in aquatic plant extracts are macro-algae. 

Seaweed extract is produced from fresh, live plants which are processed into a soluble powder or liquid and 

may be stabilized with synthetic acids and fortified with other ingredients. An alkali extraction process is 

used to “digest” the plants and derive both micronutrients and naturally occurring plant hormones. This 

process also transforms the plants into a soluble, easily transported form. The majority of manufacturers 

use potassium hydroxide as the primary reagent in the alkali extraction process. Other alkali reagents used 

by some manufacturers include sodium hydroxide, calcium hydroxide, and sodium carbonate (TR 2006 lines 

181-189). 

International Acceptance: 

Canadian General Standards Board Permitted Substances List permits use of aquatic plants products not 

containing synthetic preservatives, such as formaldehyde, and extracted with potassium hydroxide or 

sodium hydroxide. 

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

Organically Produced Foods (GL 32-1999) lists seaweed and seaweed products as a soil conditioner. 

European Economic Community (EEC) Council Regulation, 2092/91 allows aquatic plant extracts for organic 

crop production following “Annex IIB – Seaweed and seaweed products”. 

Japan Agricultural Standard (JAS) for Organic Production allows the use of dried algae as fertilizer for 

terrestrial plants. 

International Federation of Organic Agriculture Movements (IFOAM) lists seaweed as a soil input in 

appendix 2. 

Environmental Issues: 

Aquatic plant extracts are biodegradable and are likely to have a low impact on crops (TR 2006 lines 242-3). 

They are not expected to cause toxicity to plants, soil organisms, or higher animals (TR 2006 lines 151-2). 

There are no known human health hazards (TR 2006 line 320). The potential for over-harvesting of 

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kelp/seaweed fields for production of aquatic plant extracts was identified as a possible environmental 

concern in the 1995 TAP review, but it offered no additional information. 

The 2016 TR and 2016, 2017, and subsequent public comments raised concerns about the potential for 

negative environmental impact on marine ecosystems from seaweed harvesting. Some examples noted in 

the 2016 TR were specific to species used in organic crop fertility inputs and aquatic plant extracts. For 

example, in mechanical harvesting in Iceland, as with other areas where Ascophyllum nodosum and 

Laminaria digitata are harvested commercially, ecological concerns about changes in species diversity 

resulting from harvesting have been noted (TR 2016 lines 892-6). In Nova Scotia, commercial yields of 

rockweed are maintained. There still isn’t sufficient information or analysis from industry or third-party 

research proving that their harvest rate is not detrimental to the habitat value that rockweed provides to 

associated plants and animals. Estimated recovery times based on percentages removed vary between 

publications (TR 2016 lines 597-600). Additionally: 

There is one species of red algae and two species of brown algae growing along the coasts 

of the United States that have gained attention as ecologically threatened in recent years. 

They are respectively, Irish moss (Chondrus crispus), rockweed (Ascophyllum nodosum), and 

giant kelp (Macrocystis pyrifera). These plants are economically important and drive 

several seaweed industries including cosmetic products, nutraceuticals, fertilizers and 

hydrocolloids. Fertilizer applications are similar to farmyard manure, but may also include 

extracts and foliar applications (Chojnacka, 2012). 

Kelp and rockweed, are foundational species forming large expansive marine habitats 

supporting a diverse range of wildlife, including other algal species, marine animals and 

many species of protozoans and bacteria (Seeley and Schlesinger, 2012). Without a good 

accounting of all of the species present it is hard to predict the effects of harvesting 

rockweed and kelp on each ecological niche. Thus, it has been important to recognize that 

sustainable seaweed production perceived as reproducible harvest capacity, may not 

guarantee the sustained subsistence of each resident species. Although not part of any 

agricultural waste stream, extracts from wild-harvested kelp and rockweed are allowed for 

use in organic production as soil amendments (§205.601(j)(1)). [TR 2016 lines 522-535]. 

Even within the 2016 TR, differences of opinion about the environmental impacts of harvesting were noted 

within the scientific community. For example: 

One study addressing the major components of the resident fish community in the rocky 

intertidal zone after rockweed harvest found no evidence linking rockweed harvest to 

changes in the ichthyoplankton component or the juvenile and adult fish of that community 

(van Guelpen and Pohle, 2014). In a summarized review of selected work, a researcher at 

the University of Maine also concluded that the effect of 17% rockweed harvest on some 

species including seabirds was negligible (Beal, 2015). [TR lines 326-31] 

The TR goes on to explain that: 

Notwithstanding, rockweed has an important role as habitat, as food and as a nutrient 

source supporting a community of organisms that inhabit its “forests.” Any cutting of 

rockweed can produce an effect on the supported eco-communities. Furthermore, many 

aspects of this ecosystem have not been elucidated, encouraging more precaution as the 

brown algae “forestry” industry grows into the future (Seeley and Schlesinger, 2012). [TR 

lines 356-60] 

Subcommittee Review: 

As part of the Spring 2020 public meeting, the Crops Subcommittee asked what species of seaweed are 

used in aquatic plant extracts but received very few comments on this topic. The Board asked if 

nonsynthetic alternatives to this material provide the same functionality. Several harvesters stated that 

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nonsynthetic forms require more seaweed biomass to achieve the same benefit. One commenter noted 

that natural extracts are available and expressed concern over environmental impacts of harvesting. A 

broad range of stakeholders affirmed their support for this material, noting that growers have long 

experience with aquatic plant extract as part of organic fertility management plans. Certifiers reported a 

very high number of farmers who list this material in their Organic System Plans, and the Board heard 

directly from growers who rely on this material. One suggested that the board continue to allow this 

material while simultaneously exploring the environmental impact. 

The Subcommittee was divided on this topic. Two members expressed a desire to gather more 

information, particularly with regard to the related work agenda item of marine macroalgae in plant fertility 

products in the Materials Subcommittee, before making a final determination on their position on this 

material. One member was concerned about the environmental impact of harvests. 

Subcommittee Vote: 

Motion to remove aquatic plant extracts from §205.601 (j) based on the following criteria in the Organic 

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A 

Motion by: Emily Oakley 

Seconded by: Wood Turner 

Yes: 1 No: 3 Abstain: 2 Absent: 2 Recuse: 0 

Lignin sulfonate 

Reference: 205.601(j) As plant or soil amendments. (4) Lignin sulfonate —chelating agent, dust 

suppressant. 

Technical Report: 1995 TAP; 2011 TR 

Petition(s): 2014 Petition to remove as floating agent 

Past NOSB Actions: 10/1995 NOSB Minutes and vote; 04/2006 Sunset Rec; 04/2011 NOSB Rec to amend, 

04/2011 NOSB Sunset Rec; 10/2015 NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Lignin sulfonate is currently included on the National List as a synthetic substance allowed for use in organic 

production. It is used in a plant or soil amendment as a dust suppressant or chelating agent. 

Manufacture: 

Lignin sulfonates are produced from the process of sulfite chemical pulping. Sulfite pulping involves 

cooking softwood chips under pressure in sulfur dioxide-containing cooking liquors. When the cooking 

process is complete, sulfonated lignin is collected as a liquid by-product in the spent liquor, while the pulp is 

used for paper production. Lignin sulfonates may also be obtained from the Kraft pulping process and is 

similar to sulfite pulping, but involves treating the wood at high temperatures and pressure in a water 

solution containing sodium sulfide and sodium hydroxide. 

International acceptance: 

The Canadian General Standards Board allows the use of lignin sulfonate as a dust suppressant, formulant 

ingredient and chelating agent. IFOAM includes calcium lignosulfonate on its "Indicative List of Substances 

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for Organic Production and Processing." As of 2009, calcium lignosulfonate is allowed by CODEX 

Alimentarius Commission as a food additive. Lignin sulfonate is not specifically discussed by the European 

Economic Community Council regulations. 

Environmental issues and human health: 

Sodium lignosulfonate is relatively low in toxicity based on results of tests in laboratory animals. However, 

high doses have been found to cause adverse health effects in laboratory animals. Rats that were given 

drinking water containing purified sodium lignosulfonate at a 10 g/100 ml concentration for 16 weeks had 

skin lesions, decreased weight gain and increased white cell counts. No evidence of genotoxicity was found 

in microbial assays and in a test for chromosomal aberration in Chinese hamster cells. Lignin sulfonates are 

soluble in water, so it is possible for dissolved lignosulfonates to enter waterways through direct 

contamination or soil runoff. Also, as they break down in water they consume dissolved oxygen in water 

due to their high BOD, which affect aquatic organisms through decreased available oxygen. In a previous 

TAP Report (1995) the issue of potential dioxin contamination was addressed as a potential contaminant 

from the process of pulping paper. Dioxin is created during the bleaching process of paper production and 

the lignosulfonates are removed from the pulp before the bleaching process making it unlikely they would 

be generated. 

Lignin sulfonates break down by physical or microbiological processes but may persist in soil for up to one 

year. Breakdown of lignin sulfonate occurs in part because it is used as a carbon source by a variety of 

wood-decaying organisms. It is postulated that large amounts of lignin sulfonate applied to soils could 

stimulate soil microbial activity. 

The EPA issued an exemption from the requirement of tolerance for lignin sulfonates when they are used as 

inert ingredients pre- and post-harvest in agricultural production. The exemption is based on the 

conclusion that there is a reasonable certainty the no harm will result to the general public, infants and 

children from aggregate exposures to lignosulfonates. 

Magnesium chloride and calcium chloride from non-synthetic sources are allowed for use as a dust 

suppressant under certain circumstances and magnesium chloride from synthetic sources is allowed for use 

in organic agriculture for dust suppression only if it is derived from seawater. Non-synthetic amino acids 

and non-synthetic citric acid are allowed for use as chelating agents. 

Physical manipulation of landscape can also be used for dust suppression - water sprays and gravel and notill farming practices can also be used. 

Summary: 

At the last Sunset review in 2015, public comment was in support of relisting lignin sulfonate as a chelating 

agent and a dust suppressant. Lignin sulfonate is in wide use by the trade and is considered to be necessary 

for both dust suppression and as the chelating agent for many micronutrient formulations. No significant 

new issues were raised by the public at that time. At the 2020 public comment period again there were no 

comments for delisting this product and many comments stating that it was still in use. Lignin sulfonate is 

still being used extensively. One certifying agency reported that it is listed on over 

Subcommittee Vote: 

Motion to remove lignin sulfonate at 205.601(j) As plant or soil amendments. (4) Lignin sulfonate chelating 

agent, dust suppressant of the National List based on the following criteria in the Organic Foods Production 

Act (OFPA) and/or 7 CFR 205.600(b): N/A 

Motion by: Rick Greenwood 

Seconded by: Emily Oakley 

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

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Sodium silicate 

Reference: 205.601 (l) As floating agents in postharvest handling. Sodium silicate—for tree fruit and fiber 

processing. 

Technical Report: 1996 TAP; 2011 TR 

Petition(s): N/A 

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

NOSB sunset recommendation; 10/2015 NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Sodium silicate, also known as “water glass”, has had a range of uses that include fiber processing, fire 

prevention, adhesives, egg preservation, and as an anti-corrosion agent (2011 TR). For organic production, 

it may be used to modify water density in the water tanks that remove fruit from picking bins at the start of 

the packing process. This is especially important for pear packing lines since pears are denser than water 

and will sink to the bottom of the water tank. Adding sodium silicate to the water increases the density of 

the water thus causing the pears to float and making them easier to remove from the dump tank and onto 

the packing line. 

The 2011 TR notes that there are a number of uses of sodium silicate for fiber processing, but it did not 

specifically identify organic uses in fiber processing. For fiber processing in general, sodium silicate may be 

used as a peroxide buffer for processing cotton and jute. It also has uses as a bleaching agent, detergent 

for fiber cleaning, degumming of jute fibers and in combination with various other bleaching and processing 

compounds. 

Manufacture: 

Solid glass is usually produced in a rotary kiln or tank furnace by fusing quartz sand with potash or soda at 

temperatures ranging from 1,100 to 1,330 degrees C. Sodium silicate, which makes up the majority of 

soluble silicates produced, is converted from solid glass to a liquid solution at 100 degrees C. The 

concentrations of sodium silicate in water can be varied according to particular processing needs (2011 TR). 

The 2011 TR notes that the production processes for lump glass and sodium silicate require high 

temperatures and sometimes high pressures to change silicon dioxide and soda or potash to soluble 

silicates. These processes do not occur in nature and thus this material was deemed to be synthetic. 

International Acceptance: 

Sodium silicate is allowed for organic use by several international organizations (from the 2011 TR): 

Canadian General Standards Board – allows for its use for tree fruit and fiber processing 

Codex Alimentarius Commission – permits its use for the production of organic foods 

IFOAM – it is included in the silicates group and allowed under substances of mineral origin in the crop 

protectants and growth regulators with no additional conditions for use 

European Economic Community (EEC) Council Regulations – not listed for use 

Japan Agricultural Standard for Organic Production – permits it for manufacturing, packaging, storage, 

processing, other processes in the case that ordinary- ...means are not effective enough; it is restricted for 

the purpose of pest control on plants. 

Environmental Issues: 

As noted in the 2011 TR, sodium silicates are quickly diluted and depolymerize in the environment. These 

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-

processes yield molecular forms that are indistinguishable from natural dissolved silica in naturally 

occurring water. Other testing has shown these silicates to be generally non-toxic, except for contact 

exposure to very high concentrations of the material which can cause dermatitis, or, if ingested, vomiting 

and diarrhea. Additionally, the 2011 TR concluded that, based on its normal use patterns, sodium silicate is 

unlikely to contaminate soil or adversely affect soil organisms. Sodium silicate has been characterized as 

Generally-Recognized as Safe (GRAS) by the Food and Drug Administration. The U.S. Environmental 

Protection Agency has determined it is exempt from the requirement of a tolerance when used as an inert 

ingredient in pre- and post-harvest products (2011 TR). 

While normal uses of sodium silicate are unlikely to cause environmental damage, large scale spills of 

sodium silicate could have some environmental effects, either by altering the pH of the spill area or 

affecting the balance of nitrogen and phosphorous in the spill area (2011 TR). 

Subcommittee Review: 

There were few public comments received for this material during the spring 2020 comment period. One 

commenter noted that this material is not compatible with a system of organic agriculture and should be 

delisted. Other commenters noted that this material is used primarily by small pear packers to float the 

pears out of their water dump tanks and onto their packing lines. Larger pear packers utilize mechanical 

means to accomplish this, but for smaller packers, this equipment is expensive and could prevent them 

from operating. No comments were received as to the use of this material for fiber processing. 

Given that sodium silicate still provides a benefit to the organic industry, does not contribute to 

environmental degradation during normal usage, is Generally-Recognized as Safe (GRAS) by the Food and 

Drug Administration, and the U.S. Environmental Protection Agency has determined it is exempt from the 

requirement of tolerance when used as an inert ingredient in pre- and post- harvest products (2011 TR) the 

Crops Subcommittee recommends that this material remain on the National List. 

Subcommittee Vote: 

Motion to remove sodium silicate from §205.601 of the National List based on the following criteria in the 

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

Motion by: Steve Ela 

Seconded by: Wood Turner 

Yes: 0 No: 8 Abstain: 0 Absent: 0 Recuse: 0 

EPA List 4 Inerts of Minimal Concern 

Reference: 205.601(m) As synthetic inert ingredients as classified by the Environmental Protection Agency 

(EPA), for use with nonsynthetic substances or synthetic substances listed in this section and used as an 

active pesticide ingredient in accordance with any limitations on the use of such substances. (1) EPA List 4 – 

Inerts of Minimal Concern. 

Technical Report: 2015 Limited Scope TR: Nonylphenol ethoxylates (NPEs) 

Petition(s): N/A 

Past NOSB Actions: 02/1999 NOSB minutes and vote; 11/2005 NOSB sunset recommendation; 04/2010 

recommendation, 10/2010 NOSB sunset recommendation; 10/ 2012 NOSB recommendation; 10/2015 

NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

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Subcommittee Review: 

Use: 

“Inert” ingredients in pesticide formulations, also described as “adjuvants,” are added to enhance 

functionality and efficacy. Any of the pesticides approved for organic use may contain “inert” ingredients. 

For example, surfactants may improve the solubility and half-life of active pesticide ingredients. As 

described in Shistar (2017), “The relatively few registered pesticides allowed in organic production are 

contained in product formulations with so-called “inert” ingredients that are not disclosed on the product 

label. The “inerts” make up the powder, liquid, granule, or spreader/sticking agents in pesticide 

formulations. The “inerts” are typically included in products with natural or synthetic active pesticide 

ingredients recommended by the National Organic Standards Board (NOSB) and listed by the National 

Organic Program (NOP) on the National List of Allowed and Prohibited Substances.” 

Manufacture: 

Since this listing covers many different materials, the manufacture of these substances cannot be 

specifically stated. 

International Acceptance: 

Since this listing covers many different materials, a specific listing of international acceptance cannot be 

provided. 

Environmental Issues: 

As noted below, some of the materials listed on EPA List 4 may have negative environmental and human 

health consequences, while others may be relatively benign. A complete review of materials listed as to 

environmental issues is not possible without Technical Reviews of each material. 

Discussion: 

“Inerts” are not necessarily biologically or chemically inert. They may be relatively benign or may be 

documented as harmful to the environment or human health. Without a way to individually evaluate each 

substance listed on EPA List 4 or to evaluate substances as a group, it is difficult to discern the acceptability 

of each substance for use in organic agriculture. 

Presently, the National List, under §205.601(m), references the EPA List 4 – Inerts of Minimal Concern, as 

acceptable in organically approved pesticide formulations. List 4, however, is outdated and no longer 

maintained by EPA. The list of “inerts” that is referenced for review of products for organic certification 

was last updated in August 2004 (EPA website https://www.epa.gov/pesticide-registration/epas-nationalorganic-program-guidance) and may include materials that some stakeholders believe are inappropriate for 

organic agriculture. For example, nonylphenol ethoxylates (NPEs) are included on List 4. These materials 

are endocrine disruptors, may adversely impact fauna and flora, and have been identified by the California 

Department of Toxic Substances Safer Consumer Products program as a likely high priority chemical that 

should be formally phased out 

(https://www.ams.usda.gov/sites/default/files/media/NPE%20Technical%20Evaluation%20Report%20%28 

2015%29.pdf, https://dtsc.ca.gov/scp/proposed-priority-product-nonylphenol-ethoxylates-npes-in-laundrydetergents/). If evaluated on an individual basis, NPEs would likely not meet OFPA criteria for acceptability. 

Over the last decade, the NOSB and NOP have struggled with how to evaluate the EPA List 4 – Inerts of 

Minimal Concern during sunset review. OFPA has specific criteria for inerts which states: “(ii) ... contains 

synthetic inert ingredients that are not classified by the Administrator of the Environmental Protection 

Agency as inerts of toxicological concern” (§6517 C.1.B.ii). Due to EPA changes in its categorization of inerts 

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and discontinued support for List 4, the NOSB (starting in 2010) has adopted a series of recommendations 

to revise this sunset listing. 

Initially it was thought that there should not be a grouping of these materials, but that each individual 

substance should be evaluated and, if appropriate, added to the National List. However, this process was 

cumbersome, slow, and difficult to implement. It was also likely to cause uncertainty in the marketplace if 

materials already used in organic products were not recommended for listing and if a known timeline was 

not available to manufactures. At each sunset review the Board has balked at the blanket renewal of List 4 

inerts but has not had a viable alternative to relisting. During the most recent sunset review in 2015, the 

Crops Subcommittee and full Board moved forward a proposed solution to review inerts that were 

formerly on EPA List 4 by collaborating with the EPA Safer Choice Program (SCP) (formerly Design for the 

Environment Program). The specific language of the NOSB recommendation is linked here and pasted 

below: 

https://www.ams.usda.gov/sites/default/files/media/CS%20LS%20EPA%20List%204InertsAnnotation_final 

%20rec.pdf. 

Statement of the Recommendation: 

The purpose for the annotation change is to remove reference in the regulation to the EPA List 4 which is 

no longer in use and which the EPA requested be removed in 2010. In order to thoroughly evaluate inerts 

for compatibility with organic materials, the NOSB has decided to work with the EPA Safer Choice 

Program and in order to move forward with a formal relationship, an annotation change to recognize this 

collaboration is needed. The recommendation acknowledges the current nomenclature in use by the EPA 

regarding FIFRA 25(b) and 40 CFR 180.1122, while laying a framework for some inerts to be reviewed 

individually. 

205.601(m) and 205.603(e) – As synthetic inert ingredients as classified by the Environmental 

Protection Agency (EPA), for use with nonsynthetic substances or synthetic substances listed in 

this section and used as an active pesticide ingredient in accordance with any limitations on the 

use of such substances. 

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

registration under FIFRA section 25(b).1, 

(ii) Substances included on the EPA’s Safer Chemical Ingredient List. 

(iii) Inert ingredients that are exempt from the requirement of a tolerance under 40 CFR 

180.1122 – for use only in passive pheromone dispensers. 

[Reserved] (for any other inerts individually petitioned and reviewed)] 

The NOSB approved the recommendation above by a 10 to 4 vote. The NOSB then renewed the existing 

inerts listing under §205.601(m) with the expectation that a working relationship would be established 

between the NOP and EPA, with NOSB engagement, to develop a working list of acceptable inert 

materials for organically approved pesticide formulations. Acceptable inerts would be approved on a 

class basis, with room for individual material reviews and listing on the National List. To date, the NOP 

has made no changes to the regulations. 

The current situation, where NOP policies are tied to long outdated US EPA guidance, is broken. 

Numerous environmental and consumer groups have submitted comments raising concerns about the 

slow progress on resolving this problem. Private companies and advisors also assert that the lack of a 

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transparent and consistent approach for reviewing and approving “inerts” stifles development of 

organically approved plant protection tools. This undermines organic production and the larger 

agricultural economy. The issues identified in 2015 remain nearly the same during this sunset review. 

There are specific recommendations by the NOSB and a recommendation by the U.S. EPA to remove 

references to List 4 on the National List that must be acted upon. Several factors are in place for the 

NOSB, NOP, and EPA to work together to solve these problems now. The EPA Safer Choice Program is 

well established and offers a strong partner to identify acceptable inert materials. The Crops 

Subcommittee strongly requests that the NOP act on the 2015 recommendation. The concerns of product 

developers, stakeholders, and the NOSB must be addressed. This would encourage innovation of new 

products, lessen concerns of stakeholders over environmental and health concerns, and make future 

reviews of inert materials much easier. 

Figure 1. Timeline of NOSB Actions on “Inerts” (from Shistar, 20171

). 

1992 First NOSB appointed. 

1995 NOSB says it will review “inerts” after the National List is published in the Federal Register 

and passes the resolution, “Inerts on the EPA List 4 are considered generally recognized as 

safe and will be accepted for organic production, unless an 

NOSB evaluation finds a specific List 4 inert to be unacceptable. Inerts proposed for 

organic production on EPA’s List 2 which are potentially toxic and List 3 which are 

unknown will be compiled by the NOSB and forwarded to the EPA as materials for fasttrack review and possible reclassification. List 1 inerts are prohibited by the 

OFPA.” 

1997 First proposed rule would have allowed all but List 1 “inerts.” 

1999 NOSB recommends allowing List 4 and prohibiting all others, with the exception of 

particular List 3 “inerts” approved on a case-by-case basis. 

2000 Following the NOSB recommendation, the final rule allowed “inerts” on Lists 4A and 

4B. 

2002 NOSB votes to allow the use of List 3 “inerts” in passive pheromone dispensers and to 

temporarily allow List 3 “inerts” while under review. 

2004 NOSB and the public objected to a directive by the NOP that allowed the use of 

pesticides containing undisclosed “inerts,” including those on Lists 2 and 3. 

2006 EPA tells USDA that it had completed the review mandated by FQPA and would no 

longer be maintaining the “inerts” lists on which the NOP regulations depended. 

2007 NOSB relists List 3 “inerts,” limiting the renewal to those identified as List 3 by 

October 9, 2007 and says, “Future petitions to add, remove or renew an inert 

ingredient to the National List will need to reference a specific inert ingredient.” 

2008 NOSB discussion document on “inerts” options. 

2009 Another NOSB discussion document on “inerts.” 

1 Shistar, T. “Inert” Ingredients Used in Organic Production. Beyond Pesticides, Washington, D.C., 2017 

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2010 Spring: NOSB establishes the baseline position, “The NOSB needs to review all inert 

ingredient components used in current NOP compliant pesticide formulations for 

consideration for inclusion on the National List.” The 2010 recommendation also 

recommended six steps to accomplish the changes in regulation. 

Inerts Working Group (IWG) is established. 

Fall: NOSB votes to re-list List 4, with a minority opinion stressing the importance of moving 

ahead with NOSB review. The summary of the recommendation stated that 

the relisting was “pending review by the program of inerts individually and as a class 

of materials.” 

2011 IWG, through the Crops Subcommittee, submits a discussion document that 

presents some initial considerations and some proposals. 

2012 Spring: NOSB recommends an expiration date of October 21, 2017 for List 3 “inerts” in 

passive pheromone dispensers, to coincide with the sunset date for List 4 “inerts.” The NOP 

refused to codify the recommendation. 

Fall: NOSB follows up on the IWG’s 2011 discussion document by unanimously 

recommending a changed annotation and a plan of action. NOSB proposes to review of 

“inerts” by classes. 

2013 In its response to the fall 2012 NOSB meeting, the NOP said it intends to conduct a public 

notification and comment process, including notification to the public of 

“inert” ingredients known to be used in organic production and NOSB’s review plan, and a 

request for public comments regarding any other “inert” ingredientscurrently used in 

organic production that are not identified in the list provided by the NOP. It said that 

changes to the National List would be considered after NOSB completion of “inerts” review. 

Spring: NOP reiterates its intentions as stated in its response to the fall 2012 

meeting and said that a Federal Register notice to this effect was in review. 

2014 Spring: NOP update describes meetings with EPA Design for the Environment (DfE) 

program and suggests the possibility of cooperating with DfE on “inerts.” 

Fall: NOP reports that since the spring meeting: Office of General Counsel (OGC) reviewed 

the concept of collaborating with EPA; NOP provided more background to DfE; and NOP has 

been planning for interagency meetings. NOP sees next steps: (1) 

NOP and EPA meet further to develop plans for collaboration; (2) NOP consults with NOSB 

on options; and (3) public notice will be given via Federal Register. 

2015 Spring: NOP provides a TR for one category of List 4 inerts –nonylphenol ethoxylates (NPEs). 

NOP and DfE (now Safer Choice) presentations. NOP outlined “next steps”: 

(1) NOSB reviews Safer Choice to consider referring to it for “inerts” review, (2) NOSB 

reviews current List 4 reference as part of 2017 sunset review, (3) NOSB and IWG may 

draft alternate language proposal to replace current references to List 4 and List 3-for fall 

2015 meeting, (4) NOSB reviews EPA Safer Choice Criteria, and compares to OFPA criteria. 

Fall: NOSB passes an annotation to the List 4 listing on the National List that allows: 

substances permitted for use in minimal risk products, (ii) substances included on the EPA’s 

Safer Chemical Ingredients List, (iii) “inert” ingredients that are exempt from the requirement 

of a tolerance for use only in passive pheromone dispensers, 

(i) and (iv) other inerts individually petitioned and reviewed. 

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2016 Spring: Crops Subcommittee presents a discussion document on a proposal to 

prohibit use of NPEs. 

Fall: Saying that the listing will be superseded by the annotation change approved at the Fall 

2015 meeting, the NOSB votes to relist List 3 “inerts.” No further action on 

NPEs. 

1 Shistar, T. “Inert” Ingredients Used in Organic Production. Beyond Pesticides, Washington, D.C., 2017 

Subcommittee Review: 

Public comment during the April 2020 meeting was emphatically supportive of removing the reference to 

EPA List 4 on the National List and immediate implementation of prior NOSB recommendations outlined 

above. Stakeholders largely agreed that the current system is broken, unacceptable, and a threat to 

organic integrity. A key example noted by several commenters was the presence of NPEs on List 4 despite 

known concerns about their safety and the fact that they are banned by other organic governing bodies, 

including the European Union. Additionally, several organic pesticide producers confirmed that uncertainty 

resulting from reference to an outdated list of inert ingredients (List 4) stifles production of new materials 

which could benefit organic production. A typical comment from stakeholders in April 2020 is we 

“...strongly support[s] and requests that the NOP act on...” prior NOSB recommendations to end the 

reliance on EPA List 4. Commenters provided detailed roadmaps for the programmatic and administrative 

steps needed to implement existing NOSB recommendations and build necessary relationships between the 

NOSB, NOP, and the EPA Safer Choice Program. Concerns were raised by some trade organizations that 

abrupt removal of List 4 inerts would cause upheaval in the organic pesticide market and potentially limit 

the availability of some materials, especially if new formulations required efficacy and other testing. 

However, it is likely that many chemicals on the outdated EPA List 4 would be migrated to a new list of 

acceptable materials so that many existing organic pesticide formulations would be unchanged, and no new 

testing would be required. Materials that are not migrated to a new list for safety or other reasons would 

not be compatible with organic agriculture, strengthening organic integrity. For example, in public 

comments, OMRI reports that “Of the 365 distinct inert ingredients that are used in OMRI Listed products 

as of March 10, 2020, 153 appear on the EPA Safer Chemicals Ingredient List (SCIL) or the 25b Minimum 

Risk Inerts List.”, indicating that many materials on EPA List 4 would already qualify for an EPA inert SCIL for 

organic pesticide formulations. 

According to the NOP, “EPA has informed USDA that the “Inerts List” system may no longer be effective or 

available for the NOP to reference in the Regulations. Also impacted is the EPA review and labeling program 

for determining the compatibility of pesticides with the Regulations. NOP will collaborate with EPA and the 

National Organic Standards Board (NOSB) to determine the most effective and efficient way to amend the 

regulations” (https://www.ams.usda.gov/sites/default/files/media/5008.pdf). Given these 

acknowledgements, the Crops Subcommittee recommends removing EPA List 4 at 205.601(m) from the 

National list and initiating steps to implement prior NOSB recommendations to develop a Safer Chemical 

Ingredient List for inerts in an orderly manner. 

Subcommittee Vote: 

Motion to remove EPA List 4 - inerts of minimal concern from §205.601 of the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): 7 U.S.C. 

6518(m)(1) – (7) 

Motion by: Asa Bradman 

Seconded by: Wood Turner 

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

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Arsenic 

Reference: 205.602(b) 

Technical Report: none 

Petition(s): N/A 

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

NOSB sunset recommendation; 10/2015 NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Arsenic and its compounds, especially trioxide, are used in the production of pesticide 

treated wood products, herbicides, and insecticides. These applications are declining due to the toxicity of 

arsenic and its compounds. 

Arsenic is sometimes alloyed with lead to form a harder, more durable metal. Some areas of use include car 

batteries and bullets. Until recently, arsenic was commonly used in glassmaking. However, due to pressure 

from the EPA and environmentalists, most glass manufacturers have slowed down or stopped using arsenic. 

Manufacture: 

Arsenic is a naturally occurring element in the environment that can enter the food supply through soil, 

water, or air. Arsenic levels in the environment are generally low but can vary depending on the natural 

geological makeup of local areas. 

International Acceptance: 

In 2017 CODEX adopted a code of practice for the prevention and reduction of arsenic contamination in 

rice. The Codex provides national or relevant food control authorities, producers, manufacturers and other 

relevant bodies with guidance to prevent and reduce arsenic contamination in rice as source directed 

measures and agricultural measures. The Codex also includes guidance on monitoring and risk 

communication. 

Health Canada continues to monitor the concentrations of various chemicals, including arsenic, in foods 

through its ongoing Total Diet Study surveys and also conducts targeted surveys of arsenic in specific foods. 

Additionally, the Canadian Food Inspection Agency carries out monitoring and surveillance work for arsenic 

in foods, including those commonly consumed by infants and children. Health Canada will also continue to 

evaluate the potential human health risks associated with dietary arsenic exposure. 

Environmental Issues: 

Contamination from mining, fracking, coal-fired power plants, arsenic-treated lumber, and arseniccontaining pesticides also contribute to increased levels of arsenic in certain locations. As a naturally 

occurring element, it is not possible to remove arsenic entirely from the environment or food supply. The 

FDA, therefore, seeks to limit consumer exposure to arsenic to the greatest extent feasible. 

The FDA tests arsenic levels in foods as part of a comprehensive approach to monitoring toxic elements and 

nutrients. The agency prioritizes monitoring inorganic arsenic levels in foods more likely to be eaten by 

infants and toddlers. These foods are a greater potential source of dietary inorganic arsenic exposure for 

infants and young children than for adults, because: 

• they are commonly consumed by infants and young children; 

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• infants and children’s dietary patterns are often less varied than those of adults, and 

• infants and children consume more food relative to their body weight than do adults. 

The FDA tests for toxic elements through: 

• the Total Diet Study; 

• the FDA’s Toxic Elements in Food and Foodware, and Radionuclides in Food compliance program; 

and 

• sampling assignments. 

• sampling assignments may be conducted in response to reports of elevated arsenic levels in certain 

foods or to focus on a specific food, food additive, or specific food group (such as foods commonly 

eaten by infants and toddlers). 

The Crops Subcommittee determined that arsenic still does not meet the OFPA criteria and sees no reason 

to recommend removing it from its prohibited status on the National List. Additionally, there were few 

public comments, and none were in support of removing arsenic from the prohibited list. 

Subcommittee Vote: 

Motion to remove arsenic from §205.602 of the National List based on the following criteria in the Organic 

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

Motion by: Jesse Buie 

Seconded by: Emily Oakley 

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

Strychnine 

Reference: 205.602(i) 

Technical Report: none 

Petition(s): N/A 

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

NOSB sunset recommendation; 10/2015 NOSB sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Strychnine is a toxic alkaloid that is a transparent crystal or white, crystalline powder. It was widely used in 

poison (toxic) baits to kill rodents and other mammals. Exposure to strychnine can be fatal. It is colorless, 

odorless and has a bitter taste. 

Strychnine can be absorbed into the body by inhalation or ingestion. It can also be injected into the body 

when mixed with a liquid. Strychnine is rapidly metabolized and detoxified by the liver. This substance is 

also well-absorbed and acts very rapidly, producing muscular hyperactivity, which can quickly lead to 

respiratory failure and death. 

Strychnine has been placed in Toxicity Category I, indicating the greatest degree of acute toxicity, for oral 

and ocular effects; inhalation toxicity is also presumed to be high. 

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According to the USDA, above-ground uses were canceled in 1988; however, it remains registered for 

below-ground use to control damage caused by pocket gophers. 

Manufacture: 

The primary natural source of strychnine is the plant Strychnos nux-vomica. This plant is found in southern 

Asia (India, Sri Lanka, and East Indies) and Australia. 

International Acceptance: 

Under the authority of the Pest Control Products Act and based on the evaluation of currently available 

scientific information, Health Canada is proposing that products containing strychnine for control of ground 

squirrels do not meet current standards for environmental protection and, are therefore, proposed to be 

cancelled. 

Canada is a member of the Organization for Economic Co-operation and Development (OECD), which 

provides a forum in which governments work together to share experiences and seek solutions to common 

problems. Strychnine is currently registered for certain uses in other OECD member countries, including the 

United States and Australia, although registered uses do not include control of ground squirrels. As of 18 

April 2018, no decisions by an OECD member country to prohibit all uses of strychnine for health or 

environmental reasons have been identified. 

Environmental Issues: 

According to the EPA, acute toxicity to birds is assumed to be very high. Subacute dietary data indicate that 

strychnine ranges from slightly to highly toxic to avian species. Strychnine may pose a threat to birds who 

may be subject to repeated or continuous exposure from spills. 

Mammalian studies indicate that strychnine is very highly toxic to small mammals on both an acute oral 

basis and dietary basis. The signs of toxicity, including death, occur within one hour. Acute freshwater fish 

data reveal that strychnine ranges from moderately to highly toxic to freshwater fish. Aquatic invertebrate 

acute toxicity data indicate that strychnine is moderately toxic to aquatic invertebrates. 

The Crops Subcommittee determined that strychnine still does not meet the OFPA criteria and sees no 

reason to recommend removing it from its prohibited status on the National List. Additionally, there were 

few public comments, and none were in support of removing strychnine from the prohibited list. 

Subcommittee Vote: 

Motion to remove strychnine from §205.602 of the National List based on the following criteria in the 

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

Motion by: Jesse Buie 

Seconded by: Rick Greenwood 

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

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National Organic Standards Board 

Crops Subcommittee Petitioned Material Discussion Document 

Ammonia Extract 

August 4, 2020 

Summary of Petition: 

The NOSB Crops Subcommittee has determined the petition by TRUE Organic Products, Inc., submitted 

April 14, 2020 to be sufficient and has requested a third-party technical review to aid the 

Subcommittee’s deliberations. The petitioner seeks to prohibit nonsynthetic ammonia extracts for use in 

organic crop production. Specifically, the petition claims that both synthetic and naturally derived forms 

of ammonia can be synthesized or derived and applied to soils in order to meet the nitrogen demand of 

plants. Since nonsynthetic sources of ammonia is not currently permitted by Certifiers and Material 

Review Organizations (but also not explicitly prohibited) in organic production and because such use of 

ammonia is caustic, lowers soil pH, is known to decrease soil biotic activity, and bypasses other soil 

based sources of nitrogen, the petitioner seeks to list ammonia extract on §205.602 of the National List 

as a prohibited nonsynthetic substance. 

Questions: 

The Crops Subcommittee seeks input from the technical review process and from stakeholders to 

answer the following questions: 

1. Is it difficult to distinguish between ammonia derived from natural and synthetic sources (the 

petitioner claims it is difficult and can only be determined by assaying the N isotopes)? In 

addressing this question please consider the distinction between ease of chemical analysis in a 

laboratory and the realities of distinguishing between ammonia sources in a commercial setting 

where fertilizer blending is common. 

2. What are the impacts of ammonia extract application on soil organic matter content, the 

microbiome of the soil, soil faunal diversity and other soil “health” indicators? 

3. Is the description presented in the petition defining ammonia products sufficiently precise to 

classify all ammonia-based products? If not, provide a more precise and inclusive over-arching 

definition. 

4. Are there any other issues with ammonia use in organic crop production that the NOSB should 

be aware of? 

Subcommittee Vote: 

Motion to accept the petitioned material discussion document on ammonia extract 

Motion by: Dave Mortensen 

Seconded by: Jerry D’Amore 

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

Approved by Jesse Buie, Crop Subcommittee Chair, to transmit to NOP August 4, 2020 

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National Organic Standards Board 

Crops Subcommittee Material Discussion Document 

Biodegradable biobased mulch film 

August 13, 2020 

Summary of biodegradable biobased mulch film 

The Crops Subcommittee (CS) is re-issuing this discussion document with updated links and questions 

below. The CS is now planning to vote on an annotation addressing biodegradable mulch film that is 

not 100% biobased in Spring 2021. 

Past discussion: 

Biodegradable biobased mulch film has been on the National List of approved synthetic substances 

since September 30, 2014, based upon an October 2012 NOSB recommendation. Historical 

information on this material is as follows: 

Reference on the National List: 205.601(b) As herbicides, weed barriers, as applicable (2) Mulches 

(iii) Biodegradable biobased mulch film as defined in §205.2. Must be produced without organisms 

or feedstock derived from excluded methods. 

Technical Report: 2012 TR; 2015 Report; NOP Policy Memorandum 15-1; Supplemental 

Technical Evaluation Report 2016 

Petition(s): 2012 

Past NOSB Actions: 10/2012 NOSB Recommendation; Memo to the NOSB with Report on 

Biodegradable Biobased Mulch Films in Organic Crop Production (Michigan State University, 

September 2019) (pdf). 

Recent Regulatory Background: Final Rule published 09/30/14 (79 FR 58655); Sunset renewal 

notice published 10/08/2019, 84 FR 53577 

I. Background from Subcommittee: 

Biodegradable biobased mulch films were approved for placement on the National List of approved 

synthetics (Biodegradable Mulch Film Made from Bioplastics) without detailing if non-biobased 

content would be allowed. The vast majority of mulch films in this category contain 20% or less of 

biobased materials, with the remainder consisting of polymers, colorings, and other synthetic 

materials. There are some products that might meet the biobased aspect of this material’s definition 

at § 205.2 but are either not biodegradable or are not used widely in production due to brittleness or 

other production issues. 

In January 2015, the National Organic Program issued Policy Memorandum 15-1, to clarify that 

biodegradable biobased mulch film must not contain any non-biobased synthetic polymer 

feedstocks. The NOSB requested a limited scope Technical Review in 2016. The questions asked for 

this limited scope TR from 2016 were as follows: 

1. What is the effect on overall soil health, including soil biology, when this materialbiodegrades? 

2. What is the cumulative effect of the continued use of this biodegradable biobased mulch 

film, on soil nutrient balance, soil biological life, and soil tilth, when used in the same area of 

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the field for 3-5-10 years? 

3. What 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? 

4. Are there different cropping systems, climate, soil types or other factors that affect the 

decomposition rate (Examples would be long cold winters, or exceptionally dry conditions, 

such as found in a desert)? 

5. Are there metabolites of these mulches that do not fully decompose, and if so, is there an 

effect upon soil health or biological life? 

The TR focused upon biobased biodegradable mulches which contain polymers and the soil and crop 

health effects they may have as they biodegrade. This supplemental TR was inconclusive, since 

research on these materials is currently limited, and the questions above were not answered to the 

NOSB crop subcommittee’s satisfaction. In addition, there are fossil-based synthetic fertilizers, used 

extensively in nonorganic agriculture, that break down in the soil and provide nutrients for plants. The 

reliance on natural fertility inputs is one of the areas where organic agriculture is different from 

nonorganic agriculture. 

An argument can be made that even though the non-biobased polymers degrading into the soil 

originate from petroleum (a nonrenewable fossil fuel), the use of this product could be considered 

environmentally friendly since it replaces plastic mulches that are currently removed at the end of 

the harvest season and end up in landfills that do not breakdown for decades if not centuries. The 

biodegradable mulches from petroleum-based polymers save labor and time, as the mulch does not 

have to be removed from the field and transported for disposal. 

The NOSB reviewed this material for its five-year sunset renewal in 2017, and decided to relist it as 

written, with the understanding that there were no products on the market that were commercially 

viable made from 100% biobased (no petroleum) materials. The crops subcommittee needed more 

information that addressed our questions above to consider a change to the annotation. If it 

remained on the National List, perhaps manufacturers would be able to develop a product that met 

that requirement of 100% biobased “ingredients”, which was the preferred outcome. 

The National Organic Program reached out to Dr. Ramani Narayan, a researcher with the Department 

of Chemical Engineering and Materials Science at Michigan State University, to provide more 

information beyond the Technical Review that had been done in 2016. The focus of Dr. Narayan’s 

report is the biodegradability of both biobased and petroleum-based mulch films with limited 

research on the effect of these products degrading into the soil over time. Section 2.7 of the report 

(available here)states: 

Environmental studies have not shown any adverse impacts associated with the incorporation 

of biodegradable mulch films (BDMs) into the soil to date. More research is needed to monitor 

any potential formation of terrestrial micro and nanoplastics from biodegradable mulch films 

and ensure that there is no residual soil ecotoxicity. There is need for tuning the 

physicochemical properties of the biodegradable mulch films with the needs of specific 

cropping systems and climates. The biodegradable mulch films could provide additional 

environmental benefits by formulating them to deliver macro and micronutrients to the crop 

as they biodegrade in soil, or deliver pesticides directly into the soil. Sintim et al. showed that 

there was no significant effect on soil health over two years of monitoring and that the soil 

microbial communities did not differ much either. They found significant enrichment in 

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bacterial and fungal gene copies under BDM treatments over 2 years, but no significant 

change under PE and no mulch. Another important observation was that repeated tillage of 

BDMs into the soil across 4 years did not impact crop yield significantly and had no major 

effect on crop quality. 

While this section points out possible negative issues with some polymers used in the 

biodegradable mulch, the vast majority of the report focused on the positive aspects when the 

mulch does biodegrade. There is discussion that the current regulation protects organic integrity 

and would not allow the use of excluded methods (some of the polymers are extracted from 

petroleum through the use of bacteria created through excluded methods), and does not allow 

materials to be used that “contribute to contamination crops, soil or water.” Organic producers 

in the European Union are allowed to use this petroleum based biodegradable mulch with no 

requirement on the percentage of bio-based ingredients. The EU will be reviewing these mulches 

in 2024 with possible changes to their annotation. The Crops Subcommittee has reviewed Dr. 

Narayan’s report, but feels there are questions that still need to be answered and invites the 

public to provide input on these issues. 

The NOP also rescinded policy memorandum 15-1 in October 2019, stating that it was redundant with 

current regulations. The requirement for 100% biobased feedstocks is articulated in the preamble of 

the final rule (79 FR 58655) and the status quo remains. Removal of the policy memorandum provides 

an opportunity for the NOSB to revise the current definition (§ 205.2) to reduce the biobased content 

requirement. The NOSB, through this discussion document, hopes to gain insight from the public on 

possible approaches. 

II Questions: 

1. Is the biodegradability of the mulch film the main issue, or should a future 

annotation include other issues? 

2. Is there information on the toxicity or effect of all secondary metabolite residues as 

the product breaks down? 

3. What is your opinion on mulch films that could be engineered to include macro or micronutrients or pesticides that would then make the mulch film provide more benefits than 

just a mulch? 

4. Is the risk/benefit of keeping plastic mulches out of landfills part of the Organic 

Food Production Act criteria the NOSB should consider when reviewing this 

material? 

5. Are there any studies that track the impact on livestock or wildlife (terrestrial, avian and 

aquatic) that might be attracted to consume pieces of the biodegradable plastic before it 

has completely degraded in 2 years or secondary metabolites that remain in the soil and 

are taken up by crops? 

6. Should a future annotation try to include consideration that different soils and climates 

might not be able to meet the biodegradability standard set in the annotation, and how 

would certifiers be able to verify the use of thematerial met the biodegradability 

standard? 

Supplemental information and questions requested: 

New research includes publications reported by the Small Fruit Horticulture Department, Western 

State University (WSU), Mount Vernon, WA 98273. Links to publications include: 

https://smallfruits.wsu.edu/plastic-mulches/ 

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https://ag.tennessee.edu/biodegradablemulch/Pages/Publications.aspx 

Additional Questions: 

1. Is there any new research on BDM film use that has not been previously submitted to the 

NOSB? 

2. Is there any evidence that BDM films contribute to microplastic pollution in soils and 

freshwater or marine ecosystems? 

3. Are their adequate sampling and laboratory methods available to determine whether BDM 

film use contributes to microplastic pollution in soils and freshwater or marine ecosystems? 

4. Is the availability of biodegradable mulch a make-or-break situation for the viability of your 

organic system? Why? 

5. Plastic films are heavily used in organic berry production systems. What other organic 

production systems are dependent on plastic films? 

6. Are any conventional growers using BDM and what is their experience with these materials? 

7. If the NOSB recommended off-site composting of BDM, would municipal compost facilities want 

to receive BDM since a large proportion of the mass is supposed to be converted to CO2 within 

2 years (based on the international standard)? 

8. Do non-biodegradable polyethylene or other films used in organic agriculture contribute to 

organic farm soil microplastics pollution even if removed at the end of the growing season? 

9. Would it be feasible to gather up and remove BDM film at the end of the season for on-farm 

or off-farm composting? 

Please comment on which of the following mutually exclusive options for regulating BDM films that 

are not 100% biobased you think is best: 

1. Continue with the current annotation with no change; 

2. Allow BDM film use followed by ploughing into soil (with some consideration for off-site 

transport), with monitoring and assessment to determine whether there are adverse impacts; 

or 

3. Allow BDM film use but require that it be gathered up at the end of the season followed by 

on-farm or off-farm composting, if feasible; or 

4. Allow BDM film use but restrict its use in certain environments where biodegradation may 

not occur in a reasonable time. 

The Crops Subcommittee looks forward to reviewing any new information and your comments. 

Vote in Crops Subcommittee: 

Motion to accept the biodegradable biobased mulch film discussion document 

Motion by: Asa Bradman 

Seconded by: Rick Greenwood 

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

Approved by Jesse Buie, Crops Subcommittee Chair, to transmit to NOSB August 13, 2020 

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National Organic Standards Board 

Handling Subcommittee Petitioned Material Proposal 

Low Acyl Gellan Gum 

June 2, 2020 

Summary of Petition (petition, 8/8/19; petition addendum; 3/6/20): 

On August 8, 2019, the NOP received a petition from CP Kelco U.S., Inc. to add low acyl gellan gum (CAS# 

71010-52-1) to the National List. The initial petition requested addition to 7 CFR 205.605(a), however 

the NOP requested the petition be revised to request addition to 7 CFR Part 205.605(b). The petition 

was provided to the Handling Subcommittee September 17, 2020 reflecting this change. 

Upon initial review of the petition, on January 6, 2020 the Subcommittee sent additional clarification 

questions to the petitioner and a response was received March 5, 2020. On March 17, 2020 the 

Subcommittee found the petition sufficient. 

Regulatory Background 

In 2004, CP Kelco U.S. petitioned to add gellan gum to the National List. In 2007, upon completion of its 

review, the NOSB recommended gellan gum be added to the National List. A proposed rule was 

published in 2009 and in 2010, gellan gum was added at 7CFR Part 205.605(a) with an annotation that 

limits its use to the high acyl form. Outside of USDA organic regulations, there is no differentiation 

between low and high acyl gellan gum made in regulatory approvals, e.g. the CAS numbers are identical 

and they are treated the same. 

In the 2010 final rule publication, the NOP responded to a comment that references the Board’s 

discussion during its review of gellan gum at its November 2007 meeting: 

The comment stated that low-acyl gellan gum is chemically modified by alkali treatment prior to 

alcohol precipitation and is, therefore, synthetic. The comment indicated that a restriction of 

the exemption to the high-acyl form aligns with the intent of the NOSB as conveyed during the 

November 27-30, 2007 meeting discussion. 

There are 2 forms of gellan gum: High- and low-acyl. To manufacture the low-acyl form, an alkali 

is added, and the temperature is raised to remove acetyl groups. A strong acid is then used to 

lower the pH and the gum is recovered from solution by clarification and precipitation. The highacyl form is not subject to deacetylation with an alkali salt. After fermentation, the high-acyl 

form is precipitated out of solution with isopropyl alcohol. 

We believe the different manufacturing processes for high- and low-acyl gellan gum merits a 

revision to the proposed amendment to clarify that only the high-acyl form of gellan gum may 

be classified as nonsynthetic. Deacetylation, the removal of acetyl group(s) from molecules, 

results in chemical change. Thus, in accordance with the NOP definition of synthetic, the 

resulting substance would be synthetic. Based upon this reasoning, we agree with the comment 

that the recommendation to add gellan gum as a nonsynthetic substance pertains only to the 

high-acyl form. Therefore, we have amended the listing by adding the annotation “high-acyl 

form only.” 

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Use 

Low acyl gellan gum is used in various food formulations, such as aspics; frostings; brownies and bakery 

fillings; gelatins and puddings; non-standardized jams and jellies; dairy drinks and soy milks; nutritional 

products; beverages (dairy alternative milks, dairy drinks, fruit drinks, drinking jellies, novelty drinks); 

beverage mixers; kefir; yogurt, sour cream and cheese where the standards of identity do not preclude 

its use; yogurt fruit and fruit sauces; marinades; pourable and spoonable dressings; and dairy desserts. 

Gellan gum is approved in animal and pet food and is also used in personal care products such as body 

washes, sunscreen/lotions, skin hydration sprays, oral care, toothpaste, and mouthwash. The typical 

amount of gellan gum in food for human consumption doesn’t exceed 0.5%. 

The mode of action is as a suspending or gelling agent with film-forming and texturizing attributes, 

forming gels in the presence of ions when heated and cooled. 

The petitioner offers a number of unique properties that they feel make gellan gum essential: 

• Gellan gum fluid gels are very good at suspending particulate matter since the suspension will 

remain stable, esp. in products containing pulp or jelly pieces. 

• It is heat stable in acid systems unlike carrageenan, which breaks down under acid conditions. 

• Gellan gum, unlike carrageenan, can be used in fruit fillings, retorted gels, or low pH beverages. 

• Use of low acyl gellan gum in hard and soft capsules gives a functionality that cannot be 

achieved with most materials currently on the National List. Carrageenan is the only material 

currently listed which offers producers of hard and soft capsules the necessary technical 

function/properties. 

• Consumers are putting pressure on manufacturers to deliver options that are not animal- or 

carrageenan- based. 

• Gellan gum is used at significantly lower levels (<20%) than other gums on the National List. 

Manufacture 

The 2018 TR on gums and the 2019 petition note gellan gum is a high-molecular weight polysaccharide, 

produced by the pure-culture aerobic fermentation of a carbohydrate with Sphingomonas elodea (ATCC 

31461), formerly known as Pseudomonas elodea. The carbohydrate fermentation substrate is comprised 

of glucose syrup derived from maize or wheat, inorganic nitrogen, an organic nitrogen source (protein) 

and trace elements. Pasteurization kills the bacteria. The structure of high acyl gellan gum consists of a 

4-sugar repeating unit with acetate and glycerate side chains. Removing the acetate and glycerate 

groups results in a linear molecule with unique properties. 

The petitioner provides the following detail specific to their manufacturing. 

• The first step of producing the gum is by inoculating a carefully formulated fermentation 

medium with this organism. 

• The medium contains a bio-based glucose syrup carbon source, phosphate, organic and 

inorganic nitrogen sources, and appropriate trace elements. 

• The fermentation is carried out under sterile conditions with strict control of aeration, agitation, 

temperature, and pH. 

• Deacylation of the gum develops the required functionality. A strong base is used to deacylate 

gellan gum. This additional step does not change the polysaccharide backbone of the molecule. 

After deacylation, acid is used to neutralize the gellan gum solution. 

o High acyl gellan gum is treated with potassium hydroxide and heated. This produces low 

acyl gellan gum and potassium acetate and potassium glycerate. The potassium acetate 

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and potassium glycerate are removed from the low acyl gellan gum during the 

precipitation and recovery of the low acyl gellan gum with isopropyl alcohol. 

• The gum is recovered by precipitation with isopropyl alcohol. 

• The precipitate is then dried and milled to a fine powder. 

• The powdered form of the product is packaged. 

In response to a question from the Subcommittee regarding the use of excluded methods in the 

production of gellan gum, the petitioner stated that the three low-acyl gellan gums they produce 

(KELCOGEL® [E], KELCOGEL® CG-LA [E], KELCOGEL® F[E]) are Non-GMO Project certified. 

International Use: 

Canadian General Standards Board Permitted Substances List (Updated in November 2015) 

On Table 6.3 (Ingredients Classified as Food Additives) of the Permitted Substances List, gums are listed 

with the annotation, “The following gums are permitted: Arabic gum, carob bean gum (locust bean 

gum), gellan gum, guar gum, karaya gum, tragacanth gum, and xanthan gum. Shall be derived using 

substances listed in Table 6.3 Extraction solvents, carriers, and precipitation aids [in the source 

document]. By exception isopropyl alcohol may also be used to derive gums” (CGSB, 2015). 

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

Organically Produced Foods (GL 32-1999) 

CODEX provides Guidelines (CODEX Alimentarius Commission, 2013) for use of food additive gums as 

follows: Gellan gum (418). CODEX General Standard for Food Additives (GSFA) provides a highly detailed 

range of uses and specifications for each of these substances (CODEX Alimentarius Commission, 2017). 

European Economic Community (EEC) Council Regulation, EC Nos. 834/2007 and 889/2008 

Gellan gum is not listed. 

Japan Agricultural Standard (JAS) for Organic Production 

Gellan gum is not listed as allowed or prohibited. (Japanese MAFF, 2012). 

International Federation of Organic Agriculture Movements (IFOAM) 

Gellan gum is neither listed as allowed nor prohibited. 

Summary of Review: 

Gellan gum, in a high acyl form as a nonsynthetic substance is already included on the National List at 

205.605(a) and has been recommended by the Board for relisting through two rounds of sunset review. 

The low acyl form of gellan gum is technically a synthetic substance as described above but is viewed 

from a regulatory and food safety perspective as identical to the high acyl form. 

The tenets of organic production tend to favor nonsynthetic options when available. However there do 

not appear to be significant differences between the nonsynthetic high acyl and synthetic low acyl forms 

of gellan gum. If a distinct functional property is sought from the use of a low acyl form, a difference in 

impact to human health and the environment through the use of the low acyl form is negligible. If use of 

low acyl gellan gum contributes to the increased growth and consumption of an organic crop and 

subsequent processed product, the gains to human health and environment over a conventionally 

produced crop and product appear to favor its compatibility with organic handling. 

Category 1: Classification 

1. Substance is for: X Handling _______ Livestock 

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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 gum, which is explicitly included in the nonagricultural substance definition at 

7 CFR Part 205.2. 

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 NOSB has discussed at length and received much public comment regarding the 

manufacture of products of fermentation and what processes constitute a synthetic or 

nonsynthetic determination. Most recently this topic was confronted during the Spring 2020 

discussion of the reclassification of L-malic acid. Based on public comment from certifiers, 

manufacturers and the authors of the TR on L-malic acid, a synthetic or nonsynthetic 

determination can vary based on where in the manufacturing process one begins the 

determination. NOP Guidance 5033 Classification of Materials and the accompanying NOP 

Guidance 5033-1 Decision Tree for Classification of Materials as Synthetic or Nonsynthetic do not 

provide clarity or guidance on where this determination is to begin. 

The 2018 TR on Gums further describes this determination as it relates to gellan (and xanthan) 

gum: 

Gellan gum and xanthan gum are produced by fermentation of a carbohydrate with 

bacteria. Fermentation is a naturally occurring biological process. The bacteria strains 

are not an agricultural source, although agricultural materials may compose the 

substrate media. After fermentation, further processing is used to separate (recover) 

the gum from the fermentation media and purify the gum for commercial use. 

Additional processing steps, as described in Evaluation Question 1, may include the 

following: 

• Gellan gum and xanthan gum undergo pasteurization. 

• Gellan gum and xanthan gum undergo alcohol precipitation (with ethanol or 

isopropanol), similarly to guar gum and locust bean gum. Maximum levels of 

residual solvents are described in Approved Legal Uses of the Substances. 

• Xanthan gum may be washed with a salt solution. 

In order for post-fermentation extracted materials to be classified as nonsynthetic, NOP 

Guidance 5033 on the Classification of Materials requires that at the end of the 

extraction process, the material: 1) has not been transformed into a different substance 

via chemical change; 2) has not been altered into a form that does not occur in nature; 

and 3) that any synthetic materials used to extract the substance have been removed 

from the final substance such that they have no technical or functional effect on the 

final product. Reviewing the post-fermentation processing steps described above 

against NOP Guidance 5033, the following conclusions are made: 

• Heating of biological materials is not considered a synthetic process. 

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• Alcohol precipitation, as described above, may be considered a nonsynthetic 

process provided that any residual solvents are removed such that they do not 

have a technical or functional effect. 

The 2018 TR on Gums appears to determine low-acyl gellan gum as potentially nonsynthetic. 

However the 2010 NOP response to comments on the proposed rule to list high-acyl gellan gum 

clarifies the view of the Program on this substance: 

“Deacetylation, the removal of acetyl group(s) from molecules, results in chemical 

change. Thus, in accordance with the NOP definition of synthetic, the resulting 

substance would be synthetic. Based upon this reasoning, we agree with the comment 

that the recommendation to add gellan gum as a nonsynthetic substance pertains only 

to the high-acyl form.” 

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 

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)] 

It does not appear that gellan gum has detrimental chemical interactions with other materials. 

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 2018 TR on Gums notes that dues to its low toxicity, the EPA exempted gellan gum from the 

requirement for a tolerance limit when used as an inactive ingredient in pesticide formulations. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)] 

The TR notes the Safety Data Sheets for the solvents used to precipitate gellan gum do not 

indicate specific impacts on the environment or biodiversity. 

The petitioner notes that any waste from the fermentation media will be discharged to the 

municipal sewage treatment plant and will be present in only trace amounts. A recovery 

procedure is used to reclaim isopropyl alcohol. 

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4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]. 

The 2006 technical report on gellan gum cites one Joint FAO/WHO Expert Committee on Food 

Additives (JECFA) study indicating no adverse human health impacts. This same study notes that 

gellan gum acts as a bulking agent and decreases serum cholesterol. 

The 2018 TR states the effect of food additive gums on the nutritional quality of foods varies 

depending on the type and amount of gum ingested because of their varied properties. The 

gums’ physiological and nutritional effects occur during transit through the stomach, small 

intestine, and colon, by reducing and mixing actions in the gut and by their effect on the 

interaction between nutrients, enzymes and mucosal cells, and finally, as a result of their 

fermentation, by the colonic microflora. Digestion of sugars and fats may change when foods 

containing gums as food additives are ingested. 

Gellan gum is not affirmed as GRAS. It is listed at 21 CFR Part 172, Food Additives Permitted for 

Direct Addition to Food for Humans, Subpart G, Gums, Chewing gum bases and related 

substances: Gellan gum, 21 CFR 172.665 

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 2018 TR notes no sources were identified that discussed environmental contamination 

resulting from the commercial manufacturing of any of the six gums. The solvent used to 

separate the gums at the dissolution phase of the process is typically isopropyl alcohol and 

residual solvent levels are established. 

The petitioner notes that because gellan gum is a polysaccharide, it is broken down by 

microorganisms found in the soil and therefore, would have a beneficial effect on soil organisms 

which in turn would benefit crops. 

6. Are there any adverse impacts on biodiversity? (§205.200) 

The 2018 TR on Gums notes the Safety Data Sheets for the solvents used to precipitate gellan 

gum do not indicate specific impacts on the environment or biodiversity. The gum itself does not 

appear to impact 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)] 

As noted in the 2018 TR on Gums, there are many natural hydrocolloids which can be 

substituted for any one of the gums currently listed on the National List. The choice of gum for a 

particular food application is dictated by the functionalities required. Some of these 

functionalities are unique to a particular gum or combination of gums. The 2018 TR goes into 

great detail on these various functionalities. 

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Alternatives do exist but may not provide the same functionality for a particular product. For 

instance, gelatin could be used as an alternative to gellan, but gellan can withstand higher 

temperatures. An alternative practice could be to make the product without the additive, 

resulting in products with different consistencies and textures. 

The high acyl form of gellan gum can be produced nonsynthetically. However as noted above, 

this form may not provide the same functionalities as low acyl gum. The 2018 TR found no 

information was indicating that organic forms of gellan gum are available commercially. 

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 

Classification Motion: 

Motion to classify low acyl gellan gum as nonagricultural, synthetic 

Motion by: Scott Rice 

Seconded by: Jerry D’Amore 

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

National List Motion: 

Motion to add low acyl gellan gum to the National List at §205.605(b) 

Motion by: Scott Rice 

Seconded by: Jerry D’Amore 

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

Approved by Asa Bradman, Handling Subcommittee Chair, to transmit to NOP August 13, 2020 

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National Organic Standards Board 

Handling Subcommittee Proposal

Review of the Ion Exchange Filtration Process and Materials Used 

August 4, 2020 

Background: 

In an August 27, 2019, memo the National Organic Program requested the NOSB provide 

recommendations related to the process of ion exchange filtration in the handling of organic products. 

It has become clear that there is inconsistency between certifiers in how they approve or disapprove 

this type of process. Some certifiers require only the solutions that are used to recharge the ion 

exchange membranes be on the National List at § 205.605. Others require that all materials, including 

ion exchange membranes and resins be on the National List. 

The National Organic Program provided clarification to certifying agents in an email sent on May 7, 

2019, that nonagricultural substances used in the ion-exchange process must be present on the National 

List. This would include, but is not limited to, resins, membranes and recharge materials. Originally, the 

NOP asked all operations to come into compliance with the statement above by May 1, 2020. However, 

in response to requests for clarification of NOP’s rationale, as well as requests to extend the timeline for 

implementation, the NOP delayed the implementation date in order to gather more information and 

requested that NOSB review the issue. 

Manufacturers and certifiers who wish to continue allowance of the ion exchange process disagree with 

some of the findings of the NOP on this complex issue. The different opinions of the need for resins, 

recharge materials and membranes to be present on the National List, as well as how they interact with 

each other and the liquid run through the process, is complicated and the NOP therefore asked the 

NOSB to take on this issue. 

A simplified summary of ion exchange, provided in the past from OMRI is as follows: 

Ion exchange is based on the principle that a solid mass with immobilized charges can attract 

the mobile ions of the opposite charge in a fluid media. In practice, this involves a column that is 

like a large pipe packed with an exchanger, which may be in the form of beads, crystals, gels, or 

granules. The fluid can pass through, but the ions in solution will be pulled out and held to the 

exchanger. The process chemically changes the resulting fluid. 

Techniques used to produce various sweeteners offer a good example of how the process 

works. Minerals, salts, proteins and color bodies occur naturally in grape juice, cane juice, beet 

juice, and corn syrup. The refinement process seeks to remove these "impurities". They are also 

naturally present or—in case of color bodies—are formed between naturally present 

components during heating. These can be removed by a number of techniques. Some are 

physical, some are chemical, and some use both. However, the use of synthetic cross-linked 

polymeric resins—such as styrene-divinylbenzene (S-DVB)—to remove certain constituents of 

liquids based on their chemical properties is a chemical process. The liquified sweetener stream 

chemically reacts with the ions present on the ion exchange resin to purify and concentrate the 

desired sugar (Cantor and Spitz, 1956). 

Other processing aids that are considered secondary food additives required petitions in order 

to be considered. In addition to the filtering / clarifying / fining agents mentioned above, these 

also included the boiler water additives, antifoaming agents, and certain enzymes. Other 

additives that are considered ‘de minimis’ in conventional processing—such as disinfectants and 

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atmospheric gases—also required petitions, reviews, and recommendations to be added to the 

National List. Ion exchange resins are known to leak from columns and thus become incidental 

additives in the food. 

Subcommittee Review: 

The question before the Handling Subcommittee essentially boils down to whether only the recharge 

materials for the resins must be on the National List or whether both the resins and recharge material 

must be reviewed and added to the List. 

The 2020 Technical Review (TR) provides a thorough review of ion exchange filtration and should be 

referred to for details on this process. It is clear that there is widespread use of ion exchange filtration 

in organic processing whether it be for removal of off-tastes, heavy metals, or clarification of the final 

product, among others. Alternatives to ion exchange filtration are not generally available. 

As noted in the 2020 TR, ion exchange filtration differs from physical filtration processes in that there is 

an actual chemical change in the ensuing product – ions (either cations or anions depending on the resin 

and desired outcome) that were present on the resin have been substituted in the final product while 

ions that were initially found in the product are left attached to the resin. This is not just a physical 

removal of material or a reaction whereby another material is used to help process the initial substance 

and then removed after that process. The 2020 TR cites various research articles and states: 

...ion exchange filtration requires the replacement of bound ions (ions initially present in the 

filtration material) by others with the same charge and requires electroneutrality... 

...ion exchange filtration is based on the principle that if an ion is removed from the treated 

substance by the filtration material, it is replaced by an ion of the same charge that began in the 

filtration material (e.g., removal of positive ion from treated substance is replaced by a different 

positive ion from the filtration material). The ion exchange process is a result of electrostatic 

attractions between the ion of interest (ion to be removed from the treated substance) and the 

charged functional groups incorporated into the filtration material. 

The final product, by passing through the ion exchange filter, does have a different ionic makeup than 

the initial product. In the case of removing “hardness” from water, the substitution of sodium for the 

original calcium in the water does not change that it is still water, per se, but it can change how that 

interacts with other materials. Thus, it seems difficult to argue that ion exchange filtration does not 

cause a chemical change in the final product, even though the chemical change may be beneficial. 

There is a different ionic makeup in the final product as compared to the initial product and the final 

product may behave slightly differently than the initial product. 

The next question is whether the ion exchange membranes and resins are secondary food additives or 

food contact surfaces. If they are food contact surfaces, then, based on past NOP guidance, they may be 

used unless explicitly prohibited. If they are secondary food additives, then they must appear on the 

National List. It is beyond the capacity of NOSB members to investigate the nuances of FDA rules and 

regulations. The NOSB received a number of public comments from our Spring 2020 discussion 

document with a number of viewpoints, however the comments from the Organic Trade Association 

gave the most details of FDA rule history on this topic: 

In a policy statement issued on December 12, 2002, after consultation with FDA, NOP clarified 

which substances are subject to review and recommendation by NOSB for inclusion on the 

National List. According to the policy, substances that are listed in 21 CFR Part 173 as secondary 

direct food additives are subject to review, unless the substances are classified by the FDA as a 

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food contact substance. In 2002, FDA clarified that ion exchange resins were food contact 

substances, therefore ion exchange resins under the 2002 policy were not subject to the 

National List process. The 2002 food contact substance policy was archived when the NOP 

Handbook was created; however it has never been formally rescinded and remains in use by 

some certifiers. 

FDA references are as follows: 

• Ion exchange resins and membranes are listed in 21 CFR Part 173 as secondary direct food 

additives, which are substances that have a technical effect in food during processing but 

not in the finished food. 

• According to FDA guidance, some secondary direct food additives also meet the definition of 

a food contact substance, which is any substance that is intended for use as a component of 

materials used in manufacturing, packing, packaging, transporting, or holding food if such 

use is not intended to have any technical effect in such food. 

• Prior to 1997, FDA regulated ion exchange resins under 21 CFR 173.25. Once Congress 

established the term “food contact substance” in the Federal Food, Drug, and Cosmetic Act 

and initiated the Food Contact Notification Program (FCN) in 1999, all ion exchange petitions 

were converted to this approval method. There was no need to alter or change prior 

approvals under § 173.25, so they were left as is. Since that time, FDA has directed all new 

approvals of ion exchange resins through its FCN program. This clearly reflects FDA’s stance 

that they are food contact substances. 

• FDA maintains a database of approved Food Contact Substances, which include ion 

exchange resins that have been classified and approved by FDA as food contact substances. 

Additionally, Ingredion submitted comments that echoed the comments from the Organic Trade 

Association: 

The regulatory classification for ion exchange resins is both a food contact substance AND a 

secondary direct food additive. https://www.fda.gov/foodjfood-ingredientspackaging/foodingredient-packaging-terms: 

• Food Contact Substance (FCS) - Section 409 of the FD&C Act defines an FCS as any 

substance that is intended for use as a component of materials used in manufacturing, 

packing, packaging, transporting, or holding food if such use of the substance is not 

intended to have any technical effect in such food. 

• Secondary Direct Food Additive (SDFA) - This term is in the title of 21 CFR 173, which 

was created during recodification of the food additive regulations in 1977. A secondary 

direct food additive has a technical effect in food during processing but not in the 

finished food (e.g., processing aid). Some secondary direct food additives also meet the 

definition of a food contact substance. 

There were no other comments received that contradicted that materials could be listed as both a 

secondary direct food additive and food contact surface. It would seem that, even though a material 

might be listed both ways, the fact that they are listed by FDA as a food contact surface, exempts those 

materials from needing to be reviewed by the NOSB and placed on the National List. 

Finally, there is the question of whether the resins or membranes themselves contribute to a change in 

the final organic product or whether, as food contact substances, they are simply a structure that holds 

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the ions to be exchanged. The 2020 TR states that there are studies that demonstrate that the resins do 

degrade over time, however that degradation is generally in terms of their loss of resin activity or 

efficiency or capacity. In other words, the resins are simply not as good at holding ions to be exchanged 

and thus need to be recharged sooner than they would when they were new. In some cases, this loss of 

efficacy may be because of a loss of functional groups that were originally present, however the 

citations referenced in the TR note that this loss seems to primarily occur during the recharge process. 

Thus, the loss of those functional groups would not be into an organic product, but rather into the 

recharge material. The 2020 TR further states that there were no published studies on the human 

health effects of the degradation of the resins found by the TR writers. Based on the findings of the TR 

and no public comments that provided scientific evidence that the resins degrade and cause changes in 

the final product it would seem that the resins act in the capacity of food contact surfaces and not 

primarily as direct food additives. 

Subcommittee Recommendation: 

The inherent nature of ion exchange leads us to the conclusion that recharge materials used to recharge 

ion exchange resins must be on the National List if they are used in the processing of organic product. 

These recharge materials leave ions on the resins and those ions will ultimately end up in the final 

organic product. The public comments received at the Spring 2020 NOSB meeting support this 

recommendation. 

There is less consensus on the question of whether the resins or membranes themselves must be 

reviewed and included on the National List. From comments received, the resins and membranes 

appear to be classified as food contact substances. There was no compelling evidence in the 2020 TR or 

public comments that the resins or membranes degrade and alter the final organic product. Based on 

this review, it is the recommendation of the NOSB that the recharge materials, but not the resins or 

membranes themselves, must be reviewed and included on the National List. 

Subcommittee vote: 

Motion to approve the recommendation on ion exchange materials 

Motion by: Steve Ela 

Seconded by: Scott Rice 

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

Approved by Asa Bradman, Handling Subcommittee Chair, to transmit to NOP August 13, 2020 

NOSB Proposals and Discussion Documents October 2020 64 of 173
 

 

 

 

 

 

 

 

Sunset 2022 

Meeting 2 - Review 

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

October 2020 

Introduction 

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

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

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

National List for use in organic handling production that must be reviewed by the NOSB and renewed by 

the USDA before their sunset dates. This document provides the substance’s current status on the 

National List, use description, references to past technical reports, past NOSB actions, and regulatory 

history, as applicable. If a new technical report has been requested for a substance, this is noted in this 

list. To see if any new technical report is available, please check for updates under the substance name 

in the Petitioned Substances Database. 

Request for Comments 

Written public comments will be accepted through October 1, 2020 via www.regulations.gov. 

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

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Sunset 2022 

Meeting 2 - Review 

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

October 2020 

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

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

group(s)).’’ 

§205.605(a) Nonsynthetics allowed: 

Kaolin 

Sodium bicarbonate 

Waxes (Wood resin) 

§205.605(b) Synthetics allowed: 

Ammonium bicarbonate 

Ammonium carbonate 

Calcium phosphates: monobasic, dibasic, tribasic 

Ozone 

Sodium hydroxide 

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

on processed products labeled as “organic.” 

Carnauba Wax 

Colors (18) 

Glycerin 

Inulin-oligofructose enriched 

Kelp 

Orange Shellac - unbleached 

Starches: Cornstarch (native) 

Starches: Sweet potato starch for bean thread production only. 

Turkish bay leaves 

Whey protein concentrate 

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Kaolin 

Reference: 205.605(a) 

Technical Report: 1995 TAP 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Filtering of organic juices, and for personal care products 

Manufacture: 

Kaolin is a soft white clay consisting principally of the mineral kaolinite. 

International: 

Allowed by Canadian Standards, CODEX, European Economic Community (EEC), Japan Agricultural 

Standards (JAS), and International Federation of Organic Agriculture Movements (IFOAM). 

Ancillary Substances: 

Unknown 

There were minimal comments about kaolin during the Spring 2020 Board meeting. Two certifiers 

commented that six entities list Kaolin in their organic system plan. The subcommittee felt this material 

was relatively benign with no significant environmental or health concerns. 

Subcommittee Vote: 

Motion to remove kaolin from §205.605 of the National List based on the following criteria in the 

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

Motion by: Kim Huseman 

Seconded by: Asa Bradman 

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

Sodium bicarbonate 

Reference: 205.605(a) 

Technical Report: 1995 TAP 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

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Subcommittee Review: 

Use: 

Sodium carbonates are used as raising (leavening) agents in food processing. Sodium bicarbonate 

(baking soda) is a common compound in baking powder; helps to regulate acidity for things like tomato 

soup, or in pastes and beverages. It can be used as an anti-caking agent or as a stabilizer helping to 

maintain the appearance and consistency of foods. Sodium bicarbonate is often used in pancakes, 

biscuits, muffins, crackers, and in cookies. It often is used in self-rising flour and confections. It may also 

be used as a neutralizer for use in butter, cream, and ice cream. 

Manufacture: 

Sodium bicarbonate (baking soda) – its main source is from natural deposits of trona ore. It can also 

come from natural brine found in Searles Lake, California. Trona ore (sodium sesquicarbonate) is heated 

and then mixed with water to dissolve the soda ash and separate out the impurities. Then it is allowed 

to evaporate to crystallization. Carbon dioxide is added to the kiln gas to a saturated pure sodium 

carbonate solution, the sodium bicarbonate then precipitates out. 

International Acceptance: 

Sodium bicarbonate is approved for use in the following organic standards: 

Canadian General Standards Board Permitted Substances List: allowed 

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

Organically Produced Foods (GL 32-1999): not specifically mentioned but sodium sesquicarbonate is 

allowed 

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

grouped under “sodium carbonates” and if so is allowed 

Japan Agricultural Standard (JAS) for Organic Production: Limited to be used for confectionary, sugar, 

processed bean foods, noodles and bread, beverages, vegetable products, processed fruits or for dairy 

products as neutralizing substance. 

International Federation of Organic Agriculture Movements (IFOAM): may be grouped with “sodium 

carbonates” and if so is allowed 

Environmental Issues: 

Since sodium bicarbonate is derived from sodium sesquicarbonate, a mined material, and the usual 

environmental issues of mining would be present. However, no major issues have been raised in past 

reviews. 

The original Technical Advisory Panel Report (TAP) combined the two sodium carbonates (sodium 

carbonate and sodium bicarbonate) for their preliminary review. The original TAP, previous 

Subcommittee reviews, public comments, historical information, and current review indicate no 

environmental concerns. Likewise, there were no human health concerns raised during the original TAP 

review or during the following sunset reviews. Previous public commenters have noted that sodium 

bicarbonate is a primary component of baking powder and is still widely used in a variety of baked 

goods, and that it is an essential leavening agent. 

The Subcommittee discussed the importance of sodium bicarbonate, its common usage, and general 

support for re-listing. Production from Trona deposits vs. the Solvay process was discussed, and the HS 

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strategized around how best to address developments in the manufacturing process. The question was 

raised as to whether requesting a work agenda item to annotate Sodium Bicarbonate to limit use to 

non-synthetic production forms and/or whether the decision tree could use some adjustment to capture 

updated manufacturing processes. 

Written and oral comments support the re-listing of sodium bicarbonate. Stakeholders confirmed wide 

usage across many categories of products. A commonly used item, stakeholders did not report major 

environmental concerns; one cited sodium bicarbonate as a great example of a National List eligible 

substance due to its non-toxic, home kitchen use as a leavening agent. 

Certifiers raised a classification question regarding the material produced from Trona deposits versus 

the use of the Solvay process for formulating Sodium Bicarbonate. Support was expressed for 

considering re-classifying and/or adding an annotation or some other guidance for clarifying the allowed 

process for Sodium Bicarbonate production. 

Subcommittee Vote: 

Motion to remove sodium bicarbonate from 205.605(a) of the National List based on the following 

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

Motion by: Mindee Jeffery 

Seconded by: Asa Bradman 

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

Waxes (Wood rosin) (sic. resin) 

Reference: 205.605(a) Nonsynthetics allowed: Waxes—nonsynthetic (Carnauba wax; and Wood resin). 

Technical Report: 1996 TAP; 2014 TR Carnauba Wax; 2014 TR - Wood Rosin 

Petition(s): N/A 

Past NOSB Actions: NOSB minutes and vote 09/1996; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation: 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Uses: 

According to the 2014 TR, wood rosin is used in organic processing and handling primarily as a 

component of fruit wax, most commonly applied to citrus fruit. 

At the most basic level, wood rosin, when formulated as part of a fruit wax, reduces the gas exchange 

between the surface of the fruit and the atmosphere, which in turn reduces the respiration rate and 

resulting weight loss. The reduced gas exchange is considered to happen in two different ways: the wax 

forms a physical barrier that the gas must permeate, and the coating also fills openings in the fruit peel 

(Hagenmaier and Baker 1993). Hagenmeier and Baker (1993) found that some factors such as thickness 

of coating, and the waxiness vs. resinous qualities of the coating, also affect the action of fruit waxes. 

For example, coating thickness is as important as type of coating for resistance to water vapor. Wood 

rosin, when formulated with carnauba wax at differing percentages, only offers limited resistance to 

water vapor unless carnauba wax consists of approximately 90% of the formula (Hagenmaeier and Baker 

1994) (2014 TR, Lines 120-128). 

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Manufacture: 

Wood chips are passed through a series of extractors where each batch of new chips is extracted with 

several portions of solvent in succession. Each portion of solvent is used on several different batches of 

chips. This is a counter-current process where fresh solvent is used on the final extraction of the wood 

chips, and then it is successively used on the chips that receive one, two or three more extractions. 

Thus, the oldest solvent is used on the freshest wood chips. After the wood chips have received the final 

solvent extraction wash, the solvent is drained, and the chips are pressure-steamed to recover any 

residual solvent. The solvent from the terpene oil-rosin solutions leaving the extractors is recovered by 

vacuum-distillation separation and reused for subsequent extraction processes. The resulting terpene 

oils are separated by fractional distillation into refined terpentine, dipentene, and pine oil. The 

remaining residue is the non-volatile extract and is considered to be crude wood rosin (not food grade). 

The crude wood rosin is further refined and purified by a liquid fractionation process. It is placed into 

refining towers where a proprietary polar solvent (Merck 2013) is used to extract the darker 

components. According to the EPA Toxic Release Inventory (2013), methanol is the likely solvent used in 

this process step. The solvent is evaporated off, recovered and reused. The resulting lighter wood rosin 

is called Vinsol and the remaining, darker grade (Grade K) wood rosin is that which is considered ‘food 

grade’ and permitted as an ingredient in citrus fruit waxes (Merck 2013). The manufacturing process 

may only differ by the solvents used, but this is the only known method for manufacturing wood rosin. 

No chemical changes occur during the extraction and refinement of wood rosin. (2014 TR, Lines 230-

248) 

International: 

Allowed under the Canadian Organic Standards 

Ancillary substances: 

Raw wood rosin is sold directly to further formulators of fruit wax and other products without any 

additional ingredients such as stabilizers or preservatives (Pinova 2013) (2014 TR, lines 141-142) 

Discussion: 

According to the 2014 TR, wood rosin is erroneously listed at 205.605(a) as “wood resin”. FDA 

regulations clearly permit and define only wood rosin and do not define or permit wood resin as a direct 

or indirect food additive. Wood resin is the raw material produced by coniferous trees prior to 

distillation of any terpene, tall oil, and other components. 

In terms of harm to the environment, wood rosin is derived from two pine species including Longleaf 

pine which is categorized as endangered by the IUCN Red List of Threatened Species (2013). While wood 

rosin is considered a by-product of the timber industry (derived from the remaining tree stumps) the 

conversion of farmland for timber use has contributed to the decline of Longleaf pine which due to its 

slow growth cannot economically compete with other pine species for replanting. 

The solvent extraction of wood rosin from the wood chips has potential to negatively affect human 

health. Although the specific solvents used by Pinova, Inc. are proprietary, the EPA Toxic Release 

Inventory (2013) suggests that methyl isobutyl ketone (MIBK) is the likely solvent used for the initial 

extraction, and methanol for the further refinement. According to the EPA (2003), human studies of 

acute inhalation exposures to MIBK indicated “transient sensory irritation, neurological effects, and/or 

strong odor sensation during exposure”. Another study showed some nose and throat irritation at an 

exposure rate of 100-200 mg/m3. A study by the National Institute for Occupational Safety and Health 

on the other hand did not find any changes in neurological or irritation systems after a 2-hour exposure 

to MIBK at 100ppm (EPA 2003). For the second extraction step, methanol is considered to be 

environmentally preferable to other solvents of similar properties (Capello, Fischer and Hungerbuhler 

2007). However, workers repeatedly exposed to methanol have experienced headaches, sleep 

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disorders, gastrointestinal problems and optic nerve damage. Exposure to large amounts of methanol 

can result in death or severe abdominal, leg and back pain (EPA 1994). No information is available on the 

carcinogenic, reproductive, and developmental effects of methanol in humans, but birth defects have 

been observed in the offspring of rats and mice exposed to methanol by inhalation (EPA 2000) (TR 2014, 

Lines 393-414) 

Most commenters from the Spring 2020 meeting are in support of relisting wood rosin. Commenters 

also suggested the addition of an annotation to include ‘not extracted using volatile synthetic solvents; 

contains only ancillary substances approved for organic production’. The Subcommittee supports the 

option of having multiple waxes which allows for more market share as some countries do not allow the 

use of certain formulations of waxes. The Subcommittee also recommends a technical correction to the 

listing - wood rosin is the accurate listing and resin should be removed. 

Subcommittee Vote: 

Motion to remove waxes (wood rosin) (sic. resin) from §205.605 of the National List based on the 

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

Motion by: Kim Huseman 

Seconded by: Scott Rice 

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

Ammonium bicarbonate 

Reference: 205.605(b) - for use only as a leavening agent 

Technical Report: 1995 TAP 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Ammonium carbonates are used as leavening agents, and may be used in baking where yeast is not 

used. Ammonium bicarbonate has critical functionality as a raising (leavening) agent in certain cookies 

and crackers. Compared to baking soda it produces more gas and in the finished baked goods, 

ammonium bicarbonate completely decomposes into water and gaseous products that evaporate during 

the baking process. It does not leave behind the salty or soapy taste that sodium bicarbonate may leave 

when used at higher concentrations. Since ammonium bicarbonate completely breaks down in heat it 

has no effect on the pH of the baked product. Ammonium bicarbonate cannot be used for moist baked 

goods since if there is more than 5% moisture in the baked good, the ammonia gas will dissolve in the 

water and give an ammoniacal flavor to the baked good. Ammonium carbonate may also help provide 

certain characteristic textures (such as in crackers), as well as aids in controlling cookie spread. 

Since this is the only leavening agent (ammonium carbonates) that is completely eliminated through the 

baking process, there are no organic alternatives to replace ammonium bicarbonate. 

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Manufacture: 

Ammonium carbonates are made from ammonia and carbon dioxide. Ammonium bicarbonate is made 

when carbon dioxide is bubbled through an ammonia solution. Crystals of ammonium bicarbonate 

precipitate from this saturated solution. It is a component of what was formerly known as sal volatile 

and salt of hartshorn. The ammonium carbonates are considered Generally Regarded as Safe (GRAS) by 

the FDA. 

International Acceptance: 

Ammonium bicarbonate is approved for use in the following organic standards: 

Canadian General Standards Board Permitted Substances List: Allowed as a leavening agent 

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

Organically Produced Foods (GL 32-1999): Not specifically mentioned but “ammonium carbonates” are 

allowed for food of plant origin 

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

grouped under “ammonium carbonates” and if so is allowed for food of plant origin 

Japan Agricultural Standard (JAS) for Organic Production: Limited to be used for processed foods of plant 

origin 

International Federation of Organic Agriculture Movements (IFOAM): May be grouped with “ammonium 

carbonates” and if so is allowed only for cereal products, confectionary, cakes and biscuits 

Environmental Issues: 

The original TAP, previous subcommittee reviews, public comments, and historical information indicated 

no environmental concerns. Ammonium bicarbonate can be an irritant to the skin, eyes, and respiratory 

system. There may be short term health effects after exposure and long term exposure may cause lung 

damage. 

The original TAP combined the two ammonium carbonates (ammonium carbonate and ammonium 

bicarbonate) for their preliminary review. These two substances have been reviewed together during 

their subsequent two sunset reviews. The original TAP, previous subcommittee reviews, public 

comments, and historical information indicated no environmental concerns. Likewise, there were no 

human health concerns raised during the original TAP review or during the following sunset reviews. 

Previous public commenters have noted that this material is still critical for organic food processing, 

especially for baking crackers and similar baked goods. 

Stakeholders reflected mixed reviews on Ammonium Bicarbonate. Some certifiers reported little or no 

handlers known to be utilizing the substance. A trade association reported that it is essential as a 

leavening agent and alternatives have not been identified. Other certifiers support re-listing and 

reported common usage. An environmental group recommended delisting due to the emission of 

ammonia and carbon dioxide during manufacture or use. 

Subcommittee Vote: 

Motion to remove Ammonium Bicarbonate from 205.605(b) of the National List based on the following 

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

Motion by: Mindee Jeffery 

Seconded by: Scott Rice 

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

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Ammonium carbonate 

Reference: 205.605(b) –for use only as a leavening agent 

Technical Report: 1995 TAP 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Ammonium carbonates are used as leavening agents. Ammonium carbonate is used as a raising 

(leavening) agent for flat baked goods, such as cookies and crackers. It is often referred to as “Bakers 

Ammonia” in cooking recipes and by chefs. Ammonium carbonate is also used to make breadsticks, 

cookies, and crackers because it helps to make them both lighter and crispier. It is also used in many 

traditional Greek cooking recipes. Ammonium carbonates are heat activated, so baked goods will not 

rise until whatever is being baked actually goes into the oven, thus helping with food preparation and 

time requirements. This is the only leavening agent (ammonium carbonates) that is completely 

eliminated through the baking process. There are no organic alternatives to replace ammonium 

carbonates. 

Manufacture: 

Ammonium carbonates are made from ammonia and carbon dioxide. Ammonium carbonate is made 

when carbon dioxide is passed through an ammonia solution and by then allowing the vapors to distill, 

thus the resulting solid is ammonium carbonate. It is a component of what was formerly known as sal 

volatile and salt of hartshorn. Ammonium carbonates are considered Generally Regarded as Safe (GRAS) 

by the FDA. 

International Acceptance: 

Ammonium carbonate is approved for use in the following organic standards: 

Canadian General Standards Board Permitted Substances List: allowed as a leavening agent 

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

Marketing of Organically Produced Foods (GL 32-1999): allowed for food of plant origin 

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

allowed for food of plant origin 

Japan Agricultural Standard (JAS) for Organic Production: Limited to be used for processed foods 

of plant origin 

International Federation of Organic Agriculture Movements (IFOAM): allowed only for cereal 

products, confectionary, cakes and biscuits 

Environmental Issues: 

The original TAP, previous subcommittee reviews, public comments, and historical information indicated 

no environmental concerns. Ammonium carbonate can be an irritant to the skin, eyes and respiratory 

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system. There may be short term health effects after exposure and long term exposure may cause lung 

damage. 

The original TAP combined the two ammonium carbonates (ammonium carbonate and ammonium 

bicarbonate) for their preliminary review. These two substances have been reviewed together during 

their subsequent two sunset reviews. The original TAP, previous subcommittee review, public 

comments, and historical information indicated few environmental concerns. Likewise, there were no 

human health concerns raised during the original TAP review or during the following sunset reviews. 

Previous public commenters have noted that this material is still critical for organic food processing, 

especially for baking crackers and similar baked goods. 

The Handling Subcommittee discussed the material, noting that Ammonium Carbonate has low levels of 

concern in both environmental and human health areas. 

An Environmental group supported delisting due to emissions of ammonia and carbon dioxide during 

manufacture and use. Certifiers listed little to no record of usage. One farm group supported relisting. 

Subcommittee Vote: 

Motion to remove Ammonium Carbonate from 205.605(b) of the National List based on the following 

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

Motion by: Mindee Jeffery 

Seconded by: Steve Ela 

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

Calcium phosphates (monobasic, dibasic, and tribasic) 

Reference: 205.605(b) 

Technical Report: 1995 TAP; 2016 TR (Phosphates) 

Petition(s): N/A 

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

recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Calcium phosphates are used as raising (leavening) agents and used as a critical component in baking 

powder (aluminium free). All three of the calcium phosphates are used as leavening agents: dough 

conditioner, yeast food, or as an expanding agent. Monobasic and dibasic calcium phosphate are often 

used for reduced sodium baking. Monobasic is also a buffer, firming agent, sequestering agent, and is 

popular in pancake mixes. It is the commonly used acid along with sodium bicarbonate used to make 

baking powder. It is also used in baked goods, such as cookies, cakes, and potato chips, and as a firming 

agent for canned fruits and vegetables. Dibasic is used in enriched flour, noodle products, and in both 

dry and cooked forms of breakfast cereals. It is often used as a dough conditioner. It also can be used as 

a thickening agent for various cheese products. Tribasic is an anti-caking agent and buffering agent. It 

also provides a very critical function as a free flow aid in finely powdered salt used in baking. 

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Additionally, it is used as a food source for yeast in bread making, as an anti-caking agent in dry 

powders, such as in spices, and as a thickener, stabilizer, and sequestering agent for some dairy 

products. Calcium is derived from either mined limestone or from oyster shells. 

Manufacture: 

Calcium and phosphorus are sourced from limestone and phosphate rock, respectively. The food grade 

phosphates are formed by reacting purified phosphoric acid with sodium, potassium, or calcium 

hydroxides (TR 2016 43-44). 

International: 

Calcium phosphates are allowed for use in Canada, IFOAM and JAS. 

Subcommittee Review: 

The NOSB Subcommittee Review of Calcium Phosphates for the 11/27/2017 review process raised 

concerns regarding the cumulative effect on human health associated with the use of phosphorous 

additives in foods. These concerns were raised by stakeholders during both the oral and written 

comment process. However, some of the oral and written comments also refuted these same health 

concerns. 

The Handling subcommittee was instructed to look into the concerns and come back to the full NOSB 

with further findings. This was done, and included a broader look at all phosphates with the following 

conclusion: 

No single phosphate food additive or ingredient can be implicated as an isolated risk factor. 

Concerns arise from the increase in cumulative use of phosphates and possible health effects on 

the general population. Given the new information and research since the last Sunset Review, 

the Handling Subcommittee requested a new Technical Report (TR) which it received in 2016. 

The TR indicates that small amounts of sodium phosphates may not cause human health 

problems, but no long term impacts are fully understood. 

In reviewing all of the comments from the Spring 2020 meeting, no further concerns were expressed 

with the exception of the original concerns stated above. There were also several specific references to 

calcium phosphate as having a positive impact on bone health. 

The Board is always concerned about allowing exceptions that could stifle innovation. However, it is our 

determination that calcium phosphates have no real substitute, particularly in baked products. 

Subcommittee Vote: 

Motion to remove calcium phosphates from §205.605 of the National List based on the following criteria 

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

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

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Ozone 

Reference: 205.605(b) 

Technical Report: 1995 TAP 

Petition(s): N/A Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 

10/2010 sunset recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Ozone is a powerful oxidant with many industrial and consumer applications related to oxidation. 

Ozone, which has approximately 150% of the oxidizing potential of chlorine, is used as an equipment 

and food disinfectant and in post-harvest treatment for produce to retard spoilage in cold storage or in 

wash water. It is an effective and environmentally benign substance used to reduce and control 

microorganisms for food safety purposes. 

Manufacture: 

Ozone, or trioxygen, is an inorganic molecule with the chemical formula O3. It is a pale blue gas with a 

distinctively pungent smell. It is an allotrope of oxygen that is much less stable than the diatomic 

allotrope O2, breaking down in the lower atmosphere to O2 (dioxygen). Ozone's odor is reminiscent of 

chlorine, and detectable by many people at concentrations as low as 0.1 ppm in air. 

Ozone is an unstable gas in the air and even more so in water. Because of this, it must be produced 

onsite. To do so, typically an oxygen supply is fed to a corona discharge system which uses ambient air 

to produce ozonated water that is used as a liquid disinfectant. 

International: 

Canadian General Standards Board Permitted Substances List 

Included as an ingredient classified as a food additive, and as a processing aid, as a food-grade cleaner, 

disinfectant and sanitizer. 

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

Organically Produced Foods (GL 32-1999) 

While section 5 outlines criteria for the inclusion of substances, the guidelines do not include a 

permitted substance list. 

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

The regulation does not specifically address the use of ozone. 

Japan Agricultural Standard (JAS) for Organic Production 

The standard limits ozone use to processed foods of plant origin, animal intestine disinfection, or as egg 

cleansing. 

International Federation of Organic Agriculture Movements (IFOAM) Norms for Organic Production and 

Processing 

The norms allow ozone as an equipment cleanser and disinfectant. 

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Ancillary Substances: 

N/A 

Environmental Issues and Human Health Impacts: 

According to the U.S. Environmental Protection Agency, ozone exposure in the air we breathe can be 

harmful to human health and the environment. However, the application of ozone directly into water as 

a disinfectant minimizes this exposure. Once introduced into water, ozone decomposes into elemental 

oxygen in a brief amount of time. Exposure to atmospheric ozone generated from on-site production 

can be minimized through equipment maintenance. 

During its first review at the April 2020 meeting, the Board received comments voicing broad support for 

the continued listing of ozone. Comments from certifiers noted 51 operations list this material in their 

organic system plans (OSPs). Numerous comments pointed to ozone’s importance as a disinfectant and 

sanitizer for food contact surfaces. Many noted the material’s essentiality in reducing microbial loads on 

finished produce and grains. 

One group acknowledged ozone’s strong oxidizing properties and usage that does not leave toxic 

residues. However, they noted the potential risk to workers from leaks in irrigation water treatment 

when the material is not transferred to the water and is released as a gas. The group encouraged the 

Crop and Handling Subcommittees to review ozone in the context of all sanitizers. 

The Handling Subcommittee considers that the positive attributes of ozone and its role in food safety 

programs outweigh the manageable risks to worker safety and supports relisting at this time. 

Subcommittee Vote: 

Motion to remove ozone from §205.605 of the National List based on the following criteria in the 

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

Motion by: Scott Rice 

Seconded by: Asa Bradman 

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

Sodium hydroxide 

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

Technical Report: 1995 TAP; 2020 TR IN PROGRESS 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Sodium hydroxide is a highly caustic substance, used as a processing aid in cocoa manufacture, as a 

caustic bath for pretzels that makes the pretzel surface smooth and helps it to develop brown color 

during baking and for removing bitterness from olives. It is also used as an alkali to peel fruits and 

vegetables, but this use is specifically prohibited in organic foods by an annotation. Sodium hydroxide is 

used to manufacture soaps, oral care products and detergents, and can be used as an ingredient in food 

preservatives to prevent the growth of mold and bacteria. Soda ash (NaCO3), Magnesium Oxide (MgO) 

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or Sodium Hydroxide can be used in the production of sugar to increase the pH and alkalinity of the 

sugar cane juice. It is highly soluble in water. 

Manufacture: 

Sodium hydroxide is derived from saltwater brine, and manufactured by the electrolysis of this salt brine 

solution. During the electrolysis process, the water (H20) is reduced to a hydrogen gas (H) and a 

hydroxide ion (OH). The hydroxide ion bonds with the sodium to form sodium hydroxide (NaOH). 

Chlorine is also produced during this process. 

International Acceptance: 

Sodium Hydroxide is listed on the Canadian General Standards Board Permitted Substances List as an 

approved food additive. It is approved for use in the CODEX Alimentarius Commission, Guidelines for the 

Production, Processing, Labeling and Marketing of Organically Produced Foods (GL 32-1999) for bakery 

wares within the food category. It is approved on the European Economic Community (EEC) Council 

Regulation, EC No. 834/2007 and 889/2008 for the production of sugar, for the production of rape seed 

and for the surface treatment on pretzels and pretzel breads. It is not listed in the Japan Agricultural 

Standard (JAS) for Organic Production. It is listed as approved by International Federation of Organic 

Agriculture Movements (IFOAM) for sugar processing and the surface treatment of traditional bakery 

products. IFOAM also has sodium hydroxide on its list of allowed cleansers and disinfectants, with the 

annotation that an intervening event or action must occur after this type of use, to eliminate risks of 

contamination. 

Ancillary Substances: 

It does not appear there are any ancillary substances associated with this material. 

Environmental Issues: 

Must be handled by personnel according to manufacturer guidelines because of caustic nature. 

Concentration of sodium hydroxide is routinely monitored in pretzel production to verify complete 

conversion to sodium bicarbonate during baking. The EPA allows sodium hydroxide for use in treating 

sewage systems to control tree roots, and as a fungicide and algicide on water well casings. Effluent 

containing sodium hydroxide is not to be discharged into lakes, streams and other public waters without 

a NPDES (National Pollutant Discharge Elimination System) permit. Well water casing treatment would 

result in minimal exposure of birds, mammals and other organisms. The EPA states that current product 

labeling helps to protect wildlife from undue exposure to sodium hydroxide. 

The recent Technical Report states there are no alternatives that provide the desired browning 

properties of pretzels. Baking soda can be used but is not sufficiently alkaline to result in distinctive crust 

and flavor. Certain varieties of olives rely on sodium hydroxide to remove bitterness, as salt or water 

curing does not result in acceptable product. Potassium carbonate, potassium bicarbonate, sodium 

carbonate, sodium bicarbonate, ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, 

magnesium carbonate and magnesium oxide, as well as sodium hydroxide can be used to alkalize cocoa. 

Each type of alkalizing agent results in different flavors and functional attributes. The label claim 

“processed with alkali” is used when these alkalis are used in cocoa production. It appears sodium 

hydroxide is the only alkali in use when an alkali is needed in sugar processing. 

The Subcommittee discussed the wide usage of sodium hydroxide in organic systems. Several brands, 

certifiers, and a trade association listed wide usage of sodium hydroxide. A trade association further 

noted that alternatives are insufficient and, if removed, products would lose organic certification as 

reformulation is not an option. 

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Several commenters suggested an annotation to limit use solely for essential purposes. An 

environmental group noted that the current annotation only lists prohibitions and requested that the 

Board investigate essential uses of sodium hydroxide and move towards allowance of essential uses 

exclusively. 

Subcommittee Vote: 

Motion to remove sodium hydroxide from § 205.605(b) of the National List based on the following 

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

Motion by: Kim Huseman 

Seconded by: Mindee Jeffery 

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

Waxes (Carnauba) 

Reference: 205.606 Waxes – nonsynthetic (Carnauba wax; and Wood resin). 

Technical Report: 1996 TAP; 2014 TR - Carnauba Wax 

Petition(s): N/A 

Past NOSB Actions: NOSB minutes and vote 09/1996; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Used as a component in fresh fruit coatings, as a candy coating, and as component of an edible coating 

for nuts. Other uses include a base for chewing gum and in soft drinks. It can also be used as a 

processing aid, as a releasing agent, and in defoamers. It’s Generally Regarded as Safe (GRAS) listing 

doesn’t provide any limitations on its use as an ingredient in food. 

When formulated as part of a fruit coating, carnauba wax functions to reduce gas exchange between the 

surface of the fruit and the atmosphere, thereby reducing the respiration rate and weight loss of the 

fruit. It also has antifungal properties beyond the creation of a gas barrier. 

Manufacture: 

The production of carnauba wax begins with leaves cut from the carnauba palm tree during Brazil’s dry 

season. They are dried in the sun and then beat or scraped until the wax falls off as a fine powder. The 

wax is collected and then either melted via steam or a solvent. The wax is then cooled and filtered via a 

filter press or through filter cloth, and then cooled and dried. The wax may also be clarified by 

centrifugation or with hydrogen peroxide. 

International: 

Allowed by Canadian Standards, CODEX, European Economic Community (EEC), Japan Agricultural 

Standards (JAS), and International Federation of Organic Agriculture Movements (IFOAM). 

Ancillary substances: 

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According to the 2014 TR, raw carnauba is sold to formulators without any additional ingredients such as 

stabilizers or preservatives. While formulations containing carnauba as the only wax are available, it is 

more common to combine it with other waxes and coasting materials, such as beeswax, candelilla wax, 

wood rosin, or shellac. 

Discussion: 

Carnauba wax was originally listed at §205.605(a) of the National List. In October 2015 the NOSB passed 

a recommendation to reclassify the substance as agricultural and move it to §205.606. 

The 2014 TR did not find the manufacture or use of carnauba wax to be harmful to the environment or 

human health. 

Unlike other fruit coating materials like orange shellac and wood rosin, carnauba wax is available 

organically. There are 19 listings in the USDA’s Organic Integrity Database. 

The Spring 2020 comment period presented arguments both for and against delisting carnauba wax at § 

205.606. Some commenters referenced the sufficient availability of organically produced carnauba wax 

and therefore supported the delisting. Others suggested the organic form does not provide a 

satisfactory result when used as a processing aid. It was also mentioned through several comments that 

waxes in general are not always used, but they are important on those occasions when and where 

necessary; having alternative forms of waxes available allows for more export opportunities due to 

regulation differences at the respective destination. 

The Subcommittee vote was split based on concerns about the use of volatiles in the production of 

carnauba wax, the possible availability of organic forms, and the issue of an unlabeled 

ingredient/additive used on produce. The Handling Subcommittee is seeking more information from 

stakeholders regarding the use of solvents in carnauba wax production. 

Subcommittee Vote: 

Motion to remove waxes (carnauba) from §205.606 of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Availability of organically produced 

alternatives. 

Motion by: Kim Huseman 

Seconded by: Scott Rice 

Yes: 4 No: 2 Abstain: 0 Absent: 1 Recuse: 0 

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Colors - Beet juice extract color, Beta Carotene, Black Currant juice color, Black/Purple 

Carrot Juice color, Blueberry Juice color, Carrot Juice color, Cherry Juice color, 

Chokeberry/Aronia Juice color, Elderberry Juice color, Grape Juice color, Grape Skin Extract 

color, Paprika color, Pumpkin Juice color, Purple Potato juice color, Red Cabbage Extract 

color, Red radish Extract color, Saffron Extract color, Turmeric Extract color 

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

solvents and carrier systems or any artificial preservative 

(1) Beet juice extract color (pigment CAS #7659-95-2) 

(2) Beta carotene extract color 

(3) Black currant juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

(4) Black/Purple carrot juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-

7, and 134-04-3) 

(5) Blueberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

(6) Carrot juice color (pigment CAS #1393-63-1) 

(7) Cherry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-

04-3) 

(8) Chokeberry—Aronia juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-

7, and 134-04-3) 

(9) Elderberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

(10) Grape juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-

04-3) 

(11) Grape skin extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3) 

(12) Paprika color (CAS #68917-78-2)—dried, and oil extracted 

(13) Pumpkin juice color (pigment CAS #127-40-2) 

(14) Purple potato juice (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134- 04-3) 

(15) Red cabbage extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3) 

(16) Red radish extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3 

(17) Saffron extract color (pigment CAS #1393-63-1). 

(18) Turmeric extract color (CAS #458-37-7) 

Technical Report: 2015 TR - Colors (all); 2011 (Beta carotene); 2012 Supplemental TR 

Petition(s): 2007 Petition 

Past NOSB Actions: 04/2007 NOSB recommendation; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation 

Recent Regulatory Background: Added to NL effective 06/21/07 (72 FR 35137); Sunset renewal notice 

published 06/06/12 (77 FR 33290); Sunset renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date (All except beta carotene): 3/15/2022 

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Sunset Date: Beta carotene extract color: 5/29/2023 

Subcommittee Review: 

Use: 

Colors are added to food products to enhance the attractiveness of the food, to assure uniformity of color, 

to add back color lost during processing, to intensify existing colors. (TR 12-25). 

Manufacture: 

Colors can be produced via a number of production methodologies that vary by individual crop and 

pigment. While most sources have common agricultural crop names, those used for color extraction are 

often specific varieties that are grown in specific geographical regions using specific production techniques 

to produce the specific pigments for coloring purposes. Since these items are listed as agricultural – 

processing is restricted to physical or biological means. The most common types of extraction will be 

water extraction, milling, pressing, drying, distillation, enzyme treatment, ethanol extraction, or oil 

extraction. The annotation prohibits the use of synthetic solvents, carrier systems and artificial 

preservatives. 

International: 

Colors are allowed on the Canadian, Codex and EU lists but are not listed on the Japanese (JAS) or IFOAM 

lists. 

Subcommittee Review: 

It should be noted that §205.600(b)(4), which states “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,” is only applicable to synthetic substances used as a 

processing aid or adjuvant per §205.600(b). Citing this section is not a reason to delist colors as they are 

only listed as agricultural, nor are they considered a processing aid or adjuvant. 

During the Fall 2015 NOSB sunset review the NOSB ultimately supported relisting all colors. However, the 

initial Subcommittee review, as well as a statement from the lead reviewer recommended removing all 

colors but beet, black currant, black/purple carrot, cherry, pumpkin, red cabbage and turmeric juices. The 

lack of complete information about availability and whether some were available in powdered form was a 

factor in the Board’s decision to relist. The Board noted the emerging presence of certified organic colors 

and recommended future NOSBs do not renew colors in whole on §205.606. Because of differences in 

supply of the various colors it is important to review each color individually rather than lumping them as a 

group. It is also worth noting that since these colors are on §205.606 they are currently subject to 

commercial availability of organic forms. 

Should those stakeholders interested in maintaining a particular color on §205.606 not respond, the NOSB 

should take that as an indication that the color no longer needs to be listed on §205.606 and vote to 

remove it. 

Public comment received during the Spring 2020 NOSB meeting addressed similar issues as the 2015 

sunset review. Arguments were made for and against the renewal of all or some of the colors, but overall 

there was a dearth of comments given the number of companies that use colors. One commenter stated 

that the onus was on users of colors covered by this listing to make the case for relisting. If there were 

few or no comments in support of relisting, the NOSB should vote to remove the color. Several companies 

noted that they were able to source certain organic colors but there was insufficient supply of other 

colors. Other companies presented comments that there is sufficient supply of nearly all colors with a few 

exceptions. One comment came from a company that said they are a large manufacturer of organic colors 

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and can supply market demands, but that price may be a deterrent for some companies. If this is the case, 

then there is commercial availability and price should not be a reason for relisting. Based on these, often 

conflicting, comments, the Handling subcommittee has compiled a list of colors where there seems to be 

sufficient organic supply and should be delisted. The Handling Subcommittee has questions about supply 

of the remaining colors. In many cases the Subcommittee was split as to whether a color should be 

relisted or delisted, and would appreciate additional public comment for the Fall 2020 meeting. A listing 

of each color follows with comments specific to that color. 

(1) Beet juice extract color (pigment CAS #7659-95-2) 

Beet juice extract received conflicting public comments with one large supplier saying they had 

adequate organic supply and another supplier asking for it to be relisted. There was also a 

comment from an end user noting they had moved to nearly all organic colors, but this color 

should be relisted because of difficulties in using the organic color. The 2015 NOSB HS 

recommended this color be relisted. One commenter noted there were 47 listings for this color in 

the Organic Integrity Database. The HS recommends that this color should be relisted. 

Motion to remove beet juice extract from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

Yes: 2 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

(2) Beta carotene extract color 

Public comment, from both manufacturers and end users, from Spring 2020 for beta carotene 

extract recommended relisting of this color. Without adequate evidence that this color has 

adequate organic supply, the HS recommends relisting of this color. 

Motion to remove beta carotene extract from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

Yes: 2 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

(3) Black currant juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

Public comment from Spring 2020 was mixed with several commenters recommending relisting 

and one manufacturer recommending that this color be delisted. One end user of this color 

commented that they had adequate supply of this color in organic forms. The 2015 NOSB HS 

review recommended relisting of this color. Given that one large manufacturer says they have 

adequate supply and that cost may be the limiting factor and that the only end user commenting 

on this color noted adequate supply, but that others comments recommended relisting, the HS 

had an even split vote as to relisting or delisting. 

NOSB Proposals and Discussion Documents October 2020 83 of 173
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Motion to remove black currant juice color from §205.606 of the National List based on the 

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

Commercial availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(4) Black/Purple carrot juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-

7, and 134-04-3) 

Public comment from Spring 2020 was mixed. One end user and one manufacturer commented 

that this color should be relisted while another end user and manufacturer noted there was 

sufficient organic supply. The end user asking for relisting noted that they were using organic 

colors for other products but needed this color relisted for another product. Another commenter 

noted there were 47 listings for this color in the Organic Integrity Database. The 2015 NOSB HS 

recommended relisting this color. Given the mixed comments, the HS recommends relisting this 

color. 

Motion to remove black/purple carrot juice color from §205.606 of the National List based on the 

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

Commercial availability 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

Yes: 2 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

(5) Blueberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting this material 

while another asked for delisting. One end user that uses mostly organic colors in other products 

asked for this color to be relisted. However, given increase in organic blueberry supply, the HS 

recommends this color be delisted. 

Motion to remove blueberry juice color from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

Yes: 4 No: 2 Abstain: 0 Absent: 1 Recuse: 0 

(6) Carrot juice color (pigment CAS #1393-63-1) 

Comments from the Spring 2020 meeting were mixed. One manufacturer asked for relisting while 

another asked for delisting. Similarly, one end user asked for relisting while another noted 

adequate organic supply. Given that there are commenters, both manufacturers and end users, 

that commented on adequate supply, HS recommends this color be delisted. 

Motion to remove carrot juice color from §205.606 of the National List based on the following 

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

availability 

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Motion by: Steve Ela 

Seconded by: Scott Rice 

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

(7) Cherry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-

04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color while another commenter noted 23 listings in the Organic Integrity Database. 

The 2015 NOSB HS recommended relisting this color. The HS had an even split vote on whether 

this color be relisted. 

Motion to remove cherry juice color from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Kim Huseman 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(8) Chokeberry—Aronia juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-

30-7, and 134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. With no other information, the HS recommends this color be relisted. 

Motion to remove chokecherry – aronia juice color from §205.606 of the National List based on 

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

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

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

(9) Elderberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. With no other information, the HS recommends this color be relisted. 

Motion to remove elderberry juice color from §205.606 of the National List based on the following 

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

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

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(10) Grape juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-

04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for delisting. One end 

user that uses organic colors in other products asked for relisting of this color. With no other 

information, the HS had an even split vote as to whether this color should be relisted. 

Motion to remove grape juice color from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(11) Grape skin extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for delisting. One end 

user that uses organic colors in other products asked for relisting of this color. With no other 

information, the HS had an even split vote as to whether this color should be relisted. 

Motion to remove grape skin extract color from §205.606 of the National List based on the 

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

Commercial availability 

Motion by: Steve Ela 

Seconded by: Scott Rice 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(12) Paprika color (CAS #68917-78-2) - dried, and oil extracted 

Public comment from Spring 2020 were mixed but were more in favor of delisting. One end user 

and one manufacturer asked for relisting. However, two other manufacturers and one end user 

commented they had adequate supply. Without comments listing the exact reasons this color 

needs to be relisted and that there are several manufacturers noting they are able to provide 

adequate supply, the HS recommends delisting this color. 

Motion to remove paprika color from §205.606 of the National List based on the following criteria 

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

Motion by: Steve Ela 

Seconded by: Kim Huseman 

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

(13) Pumpkin juice color (pigment CAS #127-40-2) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. Another commenter noted 25 listings in the Organic Integrity Database. The 

2015 NOSB HS recommended relisting. With no other information, the HS had an even split vote 

NOSB Proposals and Discussion Documents October 2020 86 of 173
 

 

 

 

 

as to whether this color should be relisted. 

Motion to remove pumpkin juice color from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(14) Purple potato juice (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. With no other information, the HS recommends this color be relisted. 

Motion to remove purple potato juice extract from §205.606 of the National List based on the 

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

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

(15) Red cabbage extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. Another commenter noted 24 listings in the Organic Integrity Database. 

With no other information, the HS had an even split vote as to whether this color should be 

relisted. 

Motion to remove red cabbage extract color from §205.606 of the National List based on the 

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

Commercial availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(16) Red radish extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. The 2015 NOSB HS recommends relisting. With no other information, the 

HS recommends this color be relisted. 

Motion to remove red radish extract color from §205.606 of the National List based on the 

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

Motion by: Steve Ela 

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Seconded by: Kim Huseman 

Yes: 2 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

(17) Saffron extract color (pigment CAS #1393-63-1). 

Public comments from Spring 2020 were mixed. One manufacturer asked for delisting noting they 

had adequate supply to meet market demands. Another manufacturer that also makes organic 

colors has asked for relisting on other colors due to difficulties in supply but did not ask for 

relisting of this color. One end user that uses organic colors in other products asked for relisting of 

this color. Given conflicting information, the HS recommends this color be relisted. 

Motion to remove saffron extract color from §205.606 of the National List based on the following 

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

Motion by: Steve Ela 

Seconded by: Asa Bradman 

Yes: 2 No: 4 Abstain: 0 Absent: 1 Recuse: 0 

(18) Turmeric extract 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. Two end users that use organic colors in other products asked for 

relisting of this color, while a third user says they have sufficient supply of organic product. 

Another commenter noted 40 listings in the Organic Integrity Database. The 2015 NOSB HS 

recommended relisting at that time. With no other information and an apparent adequate supply 

based on comments from a manufacturer and end user, the HS recommends this color be delisted. 

Motion to remove turmeric extract from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Kim Huseman 

Yes: 4 No: 2 Abstain: 0 Absent: 1 Recuse: 0 

Glycerin 

Reference: 205.606(h) Glycerin (CAS # 56-81-5)—produced from agricultural source materials and 

processed using biological or mechanical/physical methods as described under §205.270(a). 

Technical Report: 1995 TAP; 2013 TR 

Petition(s): 1995 N/A, Glycerin (2012 Petition to remove) 

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

recommendation; 10/2015 sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

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Subcommittee Review: 

Use: 

Glycerin is used in food as a binder, humectant, solvent, and carrier. It is widely used in natural flavors. It 

is used in alcohol-free applications as an alternative to ethanol (as a carrier or solvent). It is also used in 

cosmetic and personal care products as an emollient, carrier, lubricant and filler. It has a neutral to sweet 

taste. (TR 24-25) 

Manufacture: 

Glycerin can be manufactured from a variety of sources using a variety of means. Glycerin exists in nature 

as part of triglycerides as a backbone glycerin molecule with three fatty acid chains. The product must 

undergo processing to break the fatty acids from the glycerin. The processing of glycerin will determine if 

it is agricultural or non-agricultural and the organic certification status of the raw materials, processing 

plant, and compliance with the National List would determine if the product could be organic or not. It 

should be noted that it is possible to produce an organic glycerin that would be classified as nonagricultural. Common practices are high-pressure hydrolysis (considered agricultural), saponification 

(considered synthetic but possible to be certified organic if origin materials are organic and the caustic 

material is on the national list), methyl esterification (product of biodiesel, considered synthetic), and 

fermentation of carbohydrates (considered agricultural, but uncommon). Common feedstocks to produce 

glycerin are palm oil, soy oil, tallow, canola oil, and rapeseed oil. Fermented glycerin is produced from 

carbohydrates with the common source being corn. When produced from a fat, the glycerin yield is 

generally 1:10 glycerin to fatty acid. 

International: 

Glycerin is allowed in the EU (from vegetable sources), Canada (From hydrolysis of fats and oils), and 

CODEX. It is not on the Japanese (JAS) or IFOAM lists. 

In 2012 the NOSB received a petition to remove glycerin from §205.605(b), reclassify it as agricultural, and 

move its listing to § 205.606. The petitioner stated as follows: “....An important reason that glycerin 

produced by hydrolysis of fats and oils should have been included at § 205.606 is that items listed at § 

205.606 are subject to the restriction that they can be used “only when the product is not commercially 

available in organic form.” Certified organic glycerin is currently available, but there is no “commercial 

availability” requirement to incentivize processors to use it or certifiers to require it. Consequently, 

glycerin should be removed from the National List in order to encourage organic agricultural production.” 

This matter was discussed at length by the NOSB and received considerable public comment over a period 

of two years, including presentation at the NOSB meetings in Spring and Fall 2014 and Spring of 2015. 

The NOSB proposal dated October 21, 2014, included the following: 

“....Because of the confusion around classification of glycerin (depending upon the manufacturing methods 

and source material), and the concerns regarding commercial availability of organically produced glycerin, 

the Handling Subcommittee, after significant discussion, is proposing the listing of glycerin at §205.606 

and removal of glycerin from §205.605(b). ...” 

In April 2015 the NOSB voted to remove glycerin produced by hydrolysis of fats and oils from § 

205.605(b). In December 2018 the NOP finalized rulemaking on the NOSB recommendation, moving 

glycerin from § 205.605(b) to § 205.606 and changing the annotation to read “produced from agricultural 

source materials and processed using biological or mechanical/physical methods as described under 

§ 205.270(a)” 

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-

During the Spring 2020 NOSB meeting, held virtually from April 29 to May 1, 2020, and during subsequent 

Handling Subcommittee (HS) discussions, the issue of “commercial availability” was discussed and there 

was general agreement that, given the wide use of glycerin as a binder, humectant, solvent, and carrier, 

there is currently no suitable commercially available alternative. During this same time period, the HS 

addressed the question about the make-up of the remaining 1% left over from the “99% pure” claim 

attributed to glycerin? In reviewing the 2013 TR and through review of several stakeholder written 

comments, it is generally held that glycerin is at least 99% pure with the balance of the remaining material 

being water and fatty acids that, perhaps, support processing. 

Subcommittee Vote: 

Motion to remove glycerin from § 205.606 of the National List based on the following criteria in the 

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

Motion by: Jerry D’Amore 

Seconded by: Kim Huseman 

Yes: 2 No: 3 Abstain: 1 Absent: 1 Recuse: 0 

Inulin oligofructose enriched 

Reference: 205.606(j) Inulin-oligofructose enriched (CAS # 9005-80-5) 

Technical Report: 2015 TR 

Petition(s): 2007 Petition 

Past NOSB Actions: 04/2007 recommendation; 2010 NOSB sunset recommendation; 10/2015 sunset 

recommendation 

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

notice published 07/06/17 (82 FR 31241) 

Sunset Date: 6/27/2022 

Subcommittee Review: 

Use: 

Inulin-oligofructose enriched (IOE) is on the National List as a nonorganically produced agricultural product 

allowed in or on processed products labeled as “organic.” IOE is a non-digestible carbohydrate that is used 

to increase calcium bioavailability and absorption, as a soluble dietary fiber, as a noncaloric sweetener, 

and for functional effects on the texture/consistency of food. It is used in many foods including yogurt, 

baked goods, candies, jams, baby formulas, and other dairy products. 

Manufacture: 

IOE contains inulin and oligofructose, two carbohydrates found in many plant foods that function as 

dietary fiber. Oligofructose can be produced from sucrose or inulin, however, the most common 

commercial method to produce oligofructose for use in IOE production is from inulin. Inulin is a dietary 

fiber found in chicory (Belgian endive), Jerusalem artichoke (sunchokes), agave, and other plants. Chicory 

inulin is the most commercially available inulin, however in organic production, inulin is generally derived 

from Agave (Mexico) and Jerusalem artichokes (China). Chicory inulin is produced by shredding chicory 

roots, which are treated with hot water, juiced, and filtered to remove the raw inulin. The raw inulin is 

purified by treatment with calcium hydroxide, carbonated, and filtered and spray-dried. The resulting 

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inulin polymers range in chain length from 2–60 units. The shortest polymers range from 2–10 fructose 

units and are called oligofructose. The longer polymers range from 10–60 units. If insufficient amounts of 

oligofructose are present, polymers range from 10–60 units are treated with inulinase enzyme from 

Aspergillus niger to create more oligofructose and is mixed back in with the original inulin. 

Ancillary substances: 

The 2015 TR indicated no ancillary substances but noted that IOE could contain up to 20% glucose, 

fructose, and sucrose left over from the chicory source material or enzymatic conversion. Further the TR 

noted processing aids are removed in favor of a pure IOE product. The amounts of these remaining 

substances may vary, but the general approach in producing IOE is to purify the IOE solution and thereby 

limit the amount of processing aids that remain. The TR for fructooligosaccharides (FOS) noted the 

following residuals: glucose, sucrose, calcium gluconate, glucose oxidase enzyme, catalase enzyme, or 

ethyl alcohol. There are no ancillary substances to list for IOE. 

International: 

IOE is not specifically listed in the CODEX, EU, or Japanese organic standards, however, non-organic 

agricultural products are not listed in these standards. IOE is not specifically listed on the Canadian 

standards. 

In the Fall of 2015 the NOSB voted to sunset IOE based on the availability of alternatives like inulin derived 

from organic agave and the continued listing of conventional FOS. However, in the public comment period 

for the proposed rule a processor and trade association asserted that IOE from chicory was still needed. 

The USDA decided to renew the listing for IOE even though these same comments were received in the 

Fall 2015 meeting during oral comment, and were considered by the NOSB. 

During the Spring 2020 public meeting the NOSB received about 25 public comments, mostly written, with 

about 75% in favor of relisting. Of the remaining 25% about 60% expressed strong opposition citing 

commercial availability, with 40% expressing some concern, again, centering around commercial 

availability. Many of the entities in favor of relisting provided compelling documentation regarding the 

widespread use of IOE as well as examples of its unique functionality. Most of those opposed to relisting 

referenced adequate supply with little or no supporting documentation. 

Regarding the acceptability of using organic inulin + conventional FOS (already listed at §205 606), there 

were numerous public comments asserting that this alternative has a distinct lack of functionality, mostly 

concerning fiber and sweetness. 

Subcommittee Vote: 

Motion to remove inulin-oligofructose enriched from §205.606 of the National List based on the following 

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

Motion by: Jerry D’Amore 

Seconded by: Scott Rice 

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

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Kelp 

Reference: 205.606(k) Kelp—for use only as a thickener and dietary supplement. 

Technical Report: 1995 TAP; 2016 TR (Marine Plants & Algae) 

Petition(s): N/A 

Past NOSB Actions: 04/1995 NOSB recommendation; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420); Sunset renewal notice published 03/21/2017 (82 

FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Kelp is a term used for seaweeds belonging to the brown algae (Phaeophyceae) class in the order 

Laminariales. There are about 30 genera and many species. Kelp is dark green or brown in color and has 

a salty, characteristic taste. Through the 19th century, the word "kelp" was closely associated with 

seaweeds that could be burned to obtain soda ash (primarily sodium carbonate). The seaweeds used 

included species from both the orders Laminariales and Fucales. The word "kelp" was also used directly 

to refer to these processed ashes. Used for centuries in traditional Japanese food, kelp provides a 

unique flavor profile and can be used as a thickening agent or as a base for broth. Kelp can also be used 

as a source of iodine within maximum daily iodine intake limits. 

Manufacture: 

Kelp is harvested, dried and then ground or chopped for use in food. Giant kelp can be harvested fairly 

easily because of its surface canopy and growth habit of staying in deeper water. 

International: 

Kelp is allowed in Canadian General Standards Board Organic Production Systems under aquatic plants 

and aquatic plant products, Table 4.2. It is also listed in the European Union Annex IX 1.1.3 Algae, 

including seaweed, permitted in non-organic foodstuffs preparation. It is also listed in the Japanese 

Agricultural Standard for Organic Plants-Dried Algae, including the powdered form. 

Environmental Issues and Human Health Impacts: 

Kelp is a renewable resource. It is also a keystone species, and there are concerns over responsible 

harvest of kelp beds. Climate change is also impacting the distribution of kelp populations. For 

example, Northern California populations of kelp have been reduced by 90% due to sea urchin 

populations that exploded after disease killed local sea stars, which are natural predators of the urchins. 

The bacteria affecting sea stars may be increasing due to warmer water temperatures resulting from 

global warming. The impact of the loss of kelp on the California coastal marine ecosystem is potentially 

catastrophic, and the Handling Committee would like more information on the impact of harvesting on 

kelp populations. There are also concerns over contamination of kelp from ocean radiation. 

Subcommittee Discussion 

While the term “kelp” generally refers to seaweeds belonging to the brown algae in the order 

Laminariales, by tradition some forms of kelp have more specific names, for instance, wakame or 

kombu. Most kombu is from the species Saccharina japonica (Laminaria japonica). However, some 

edible kelps in the family Laminariaceae are not always called kombu, such as arame, kurome (Ecklonia 

kurome) or Macrocystis pyrifera. The name "wakame" was derived from the Japanese name wakame. 

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Starting in the 1960s, the word "wakame" started to be used widely in the United States, and the 

product (imported in dried form from Japan) became widely available at natural food stores and AsianAmerican grocery stores. There has been some confusion around the separate listings on the National 

List for wakame and kombu, both forms of edible seaweeds. 

The NOSB asked several questions of the organic community. The questions were: 

1. Are there organic supplies of kelp available? If so, are there enough organic supplies available to 

meet commercial demand? 

2. How is organic kelp’s use in livestock production different from uses for human consumption? 

3. Are there organic supplies of kelp available for human consumption? 

4. Is the availability of organic kelp enough to supply both livestock and human consumption 

demand in handling? 

5. What are the handling (human consumption) needs of kelp as a thickener and dietary 

supplement? 

Several commenters requested the delisting of kelp because of the ambiguity of the listing and 

suggested a relisting of kelp under §205.607(b) - the wild crop certification. Other commenters 

suggested relisting with an annotation. The Subcommittee also discussed, in relation to the listing of 

kelp, the NOSB’s discussion document regarding marine materials. Because the marine materials 

document will ultimately affect all marine materials, including kelp, there remains some uncertainty 

about how to proceed with kelp and other seaweeds that will have to be better defined, preferably at 

once, since many of the terms such as kelp can include other separate listings. 

Subcommittee Vote: 

Motion to remove kelp from §205.606 of the National List based on the following criteria in the Organic 

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

Motion by: A-dae Briones 

Seconded by: Steve Ela 

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

Orange shellac 

Reference: 205.606(o) Orange shellac-unbleached (CAS # 9000-59-3). 

Technical Report: 2002 TAP; 2014 TR 

Petition(s): N/A 

Past NOSB Actions: 10/1999 NOSB minutes and vote; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Orange shellac is used to coat fruits and vegetables to reduce water loss and retain firmness. It is an 

ingredient in lozenges, capsules and tablets, and is a part of confectionary glazes on candy, chocolate 

and coffee beans. A dye from shellac is used as a food color. It is a natural bio-adhesive polymer that is 

soluble in alkaline solutions such as ammonia and in solvents such as ethanol. Shellac is water insoluble. 

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There are also numerous non-food uses: on wood, in cosmetics, in clothing, on seeds, and in adhesives, 

varnish, and polishes. 

Manufacture: 

Orange shellac or “shellac” as it is commonly known is the purified product of the natural resin lac, 

which is the hardened secretion of the small, parasitic insect Kerria lacca, popularly known as the lac 

insect. These insects suck the sap of certain host trees, and when digested by the insects the sap 

undergoes a chemical transformation and is eventually secreted through the pores of the insect. When 

this secretion comes into contact with the air, if forms a hard shell-like coating over the larger swarm of 

insects. The main areas of the world where it is produced are India, Thailand, and Myanmar. 

International Acceptance: 

Orange shellac is not listed on the Canadian General Standards Board Permitted Substances List, on the 

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

Organically Produced Foods (GL 32-1999), on the European Economic Community (EEC) Council 

Regulation, EC No. 834/2007 and 889/2008, on the Japan Agricultural Standard (JAS) for Organic 

Production, nor by International Federation of Organic Agriculture Movements (IFOAM). Therefore, 

these international organic standard bodies do not allow this substance in or on organic foods. 

Ancillary Substances: 

From the 2014 Technical Report (TR), there are a number of substances that are used to process the 

orange shellac for use in fruit coatings. Some are allowed in organic production and some are not, they 

include: isopropyl alcohol, morpholine, oleic acid, candelilla wax, fatty acid soaps and fast drying 

solvents, wood rosins, paraffin wax, petroleum wax, carnauba wax, sugar cane wax, polyethylene 

emulsions, castor oil, triethanolamine, ammonia, sodium o-phenyl phenate, stearic acid, alkyl 

naphthalene sulfonates, sodium hydroxide, bentonite, borax, potassium hydroxide, glycerol, palmitic 

acid, luric acid, and stearic acid. Fungicides, growth regulators, and preservatives could be added as well 

as plasticizers such as castor oil, vegetable oils (corn, soy, etc.), acetylated monoglycerides, fatty acids, 

etc. that are not soluble in water can be used in formulating shellac products. Plasticizers are additives 

that increase the plasticity or fluidity of material. Coloring agents such as dyes, titanium dioxide, iron 

oxide, natural colors and other materials such as talc, calcium carbonate and alumina may be used. Only 

items allowed on the National List can be included in orange shellac used in or on organic products. 

Environmental Issues: 

The TR states there are no major adverse environmental effects on the production and processing of 

orange shellac. However, wash-water originating from processing units contain water soluble dye, 

fragments from insect bodies, proteinaceous matter, vegetable glue, and some sugars. These effluents 

collect in a pit outside factories and putrefy, generating an offensive smell. This may be a potential 

environmental hazard for which further studies are required. During washing of sticklac to seedlac, the 

effluents of lac factories are allowed to flow and collect in reservoirs. This accumulated water is treated 

with acid, precipitating all solid matter called lac-mud. Lac-mud is also a source of lac dye and lac wax 

(Baboo and Goswammi 437 2010). 

Discussion: 

At the previous sunset review, public commenters expressed the desire to add an annotation that would 

require labeling of fruits and vegetables that may have had orange shellac applied. This option would be 

a future work agenda item, since annotations are not changed at sunset. The TR states: “There have 

been no reports showing adverse effects on human health due to orange shellac. Some individuals may 

show allergic symptoms and some vegetarians may consider it an animal product not suitable for their 

consumption.” Corn zein and starch are alternative materials for shellac that provide a high gloss to 

some food products. For example, zein is a protein of the prolamine group occurring in maize and used 

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in food coating. Carnauba wax has been used commercially to coat apples but has less gloss than shellac. 

There are primarily four different non-synthetic substances that may be used in place of orange shellac 

as a component of citrus fruit waxes: wood rosin, carnauba wax, beeswax, and candelilla wax. Each has 

their own positives and negatives for handling purposes, including shine, permeability, cost, etc. 

Limited public comments were presented during the Spring 2020 meeting; however, all the comments 

supported relisting orange shellac. Public commenters again suggested adding an annotation that 

would require labeling of fruits and vegetables that may have had orange shellac applied. As noted 

above, this would be a future work agenda item since annotations are not addressed during the sunset 

review. A petition is currently under review by the Board for corn zein, an alternative material to orange 

shellac that also provides a high gloss finish to some foods. The Subcommittee was split over relisting 

orange shellac. There is lack of information about whether its use in organic products is widespread or 

necessary as well as the absence of comments on this ingredient. 

Subcommittee Vote: 

Motion to remove orange shellac from §205.606 of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Alternatives, 7 U.S.C. 6518(m)(6) 

Motion by: Kim Huseman 

Seconded by: Jerry D’Amore 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

Starches: cornstarch 

Reference: 205.606(s) Starches. 

(1) Cornstarch (native). 

Technical Report: 1995 TAP - Cornstarch 

Petition(s): N/A - Cornstarch; 2007 Petition - Sweet Potato Starch 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 10/2010 sunset recommendation on cornstarch; 

10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420); 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

“Starches are used in many foods as thickeners, formulation aids, to make corn syrup, and as 

bulking agents and moisture adsorption agents. Cornstarch is made from special strains of corn 

that are high in amylose and amylopectin” (prior review). 

Manufacture: 

Cornstarch is obtained from the endosperm of the kernel. The corn is steeped for 30 to 48 

hours, which ferments it slightly. The germ is separated from the endosperm and those two 

components are ground separately (still soaked). The starch is then removed by washing. The 

starch is separated from the corn steep liquor, the cereal germ, the fibers and the corn gluten 

mostly in hydrocyclones and centrifuges, and then dried. This process is called wet milling. 

Finally, the starch may be modified for specific uses. 

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Ancillary substances: 

None noted. 

International acceptance: 

Canada: Yes, with restrictions on materials used for manufacture. 

Codex: Not listed. 

EU: From corn, not chemically modified. 

Japan: Not listed. 

IFOAM: Not listed 

Environmental/Health Issues: 

Cornstarch poses no acute health hazards from ingestion or dermal absorption. Dusts 

produced during production may pose inhalation risks, and potentially a fire hazard if levels in 

air reach critical combustion concentrations. Cornstarch that is not organic may be produced 

from conventional corn that was grown with synthetic fertilizers and pesticides that pose risks 

to human health and the environment. 

Discussion: 

There are organic starches on the market, but they are not necessarily suitable for all uses. “Cornstarches 

are described by the relative content of two glucose polymers: amylopectin and amylose. Special strains 

of corn are grown to achieve the right ratio of the polymers and these special varieties are all identity 

preserved to maintain their amylose ratio and so are never genetically engineered”. During the 2017 

review, public commenters indicated that some types of organic cornstarch are not available. A recent 

search of the Organic Integrity Database identified 55 suppliers of “cornstarch” or “corn starch”, 

including many in the United States. Cornstarch is listed under §205.606, so non-organic material 

should be used only when organic cornstarch is not available. The Handling Subcommittee requested 

public comment on the need to list cornstarch under §205.606. 

During the Spring 2020 NOSB meeting, many certifiers, trade organizations, and food manufacturers 

supported relisting of cornstarch on §205.606. Although various forms of organic cornstarch are 

available and abundant, many commenters noted that some organic forms were not functional to 

manufacture their products or there was not enough specialized organic material available to meet their 

needs. Overall, certifiers and producers reported non-GMO derived cornstarch, albeit not organic, was 

readily available. Several organic cornstarch manufactures reported production of thousands of metric 

tons of organic cornstarch and also possible alternatives derived from pea starch or other products. One 

commenter recommended an annotation limiting cornstarch on §205.606 to specialized forms that are 

not available organically and thus encouraging broader use of available organic cornstarch when it 

meets production requirements. Note that an annotation is beyond the scope of the sunset review and 

would have to be considered as a separate work agenda item. The Subcommittee wanted to encourage 

policies that increase use of organically sourced cornstarch and there was debate about whether this 

could be accomplished by an annotation as described above or by removing cornstarch, as listed, from 

§205.606, and encouraging direct listing of any specialized forms that are not available organically. The 

Subcommittee ultimately voted to recommend removal of cornstarch from §205.606 because of an 

abundant supply of organic cornstarch. 

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Subcommittee Vote: 

Motion to remove starches: cornstarch from §205.606 of the National List based on the following 

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

Motion by: Asa Bradman 

Seconded by: Scott Rice 

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

Starches: sweet potato 

Reference: 205.606(s) Starches. 

(2) Sweet potato starch - for bean thread production only. 

Technical Report: 1995 TAP - Cornstarch 

Petition(s): N/A – Cornstarch; 2007 Petition - Sweet Potato Starch 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 10/2010 sunset review Sweet potato starch; 

10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Sweet potato starch is specifically used as a formulation aid for bean thread production. 

Manufacture: 

The sweet potatoes are crushed, and the starch is washed out and dried to a powder. 

Ancillary substances: 

None noted. 

International acceptance: 

Canada: Not listed. 

Codex: Not listed. 

EU: Not listed. 

Japan: Not listed. 

IFOAM: Not listed 

Environmental/Health Issues: 

Sweet potato starch poses no acute health hazards from ingestion or dermal absorption. Dusts produced 

during production may pose inhalation risks. Sweet potato starch that is not organic may be produced 

from conventional sweet potatoes that were grown with synthetic fertilizers and pesticides that pose 

risks to human health and the environment. 

Discussion: 

A recent search of the Organic Integrity Database identified two suppliers of “sweet potato starch”, 

including one in the United States and one in China. Sweet potato starch is listed under §205.606, so 

non-organic forms can be used only when organic cornstarch is not available. The Handling 

Subcommittee requested public comment on the need to list cornstarch under §205.606 and whether 

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current supplies are adequate to meet demand for organic bean thread products. 

Public comment on sweet potato starch was very limited, with only a few reported users of this project. 

One organic starch manufacturer suggested pea starch provided a workable alternative to sweet potato 

starch, although this claim was not addressed by food producers currently using sweet potato starch. 

Another commenter noted that taking sweet potato starch off §205.606 would likely increase 

availability of organically sourced material. The Subcommittee wanted to encourage policies that 

increase use of organically sourced sweet potato starch and ultimately voted to recommend removal of 

sweet potato starch from §205.606 to encourage use of organically sourced material. 

Subcommittee Vote: 

Motion to remove starches: sweet potato starch from §205.606 of the National List based on the 

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

availability 

Motion by: Asa Bradman 

Seconded by: Jerry D’Amore 

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

Turkish bay leaves 

Reference: 205.606(u) Turkish bay leaves. 

Technical Report: N/A 

Petition(s): 2006 Petition 

Past NOSB Actions: 04/2007 recommendation; 10/2010 NOSB sunset recommendation; 10/2015 sunset 

recommendation 

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

renewal notice published 07/06/17 (82 FR 31241) 

Sunset Date: 6/27/2022 

Subcommittee Review: 

Use: 

Turkish bay leaves are an herb that has been used traditionally to flavor food. 

Manufacture: 

Turkish bay leaves (Laurus nobilis) are widely cultivated in the Mediterranean and Asia. Leaves are 

harvested, sorted and then sold fresh or dried. 

International: 

There is no list of individual non-organic agricultural commodities allowed under the Japanese 

Agricultural Standards (JAS), International Federation of Organic Agricultural Movements (IFOAM) or 

Codex standards. However, these standards allow for up to 5% non-organic content. The EU Organic 

Standards do not list Turkish bay leaves. 

Ancillary Substances: 

None noted 

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Discussion: 

During the review of 2017 sunset materials conducted in 2015, the NOSB requested information from 

the public to assess commercial demand, commercial availability, alternatives, necessity and use in 

organic production. At that time, the original petitioner noted a source of Turkish bay leaves but 

believed the supply was too fragile to have the listing removed. Searches of publicly available organic 

sourcing pages by the NOSB in June of 2015 resulted in 85 NOP organic certificate holders of bay leaves 

with 12 specifying Laurus nobilis. Additionally three spice companies were contacted, and all had 

sources of Turkish bay leaves from Turkey, India or both. 

One commenter noted concern regarding impacts of pesticide use and residue when a conventional 

agricultural ingredient is used. Products certified to the “made with organic...” may use non-organic 

agricultural ingredients that are not listed on §205.606 and have not undergone a review for compliance 

with OFPA criteria. However, these ingredients are still required to comply with §205.105, which 

prohibits ingredients that are irradiated, produced with sewage sludge or with excluded methods. 

Additionally, the commenter provided no data specifically on pesticide usage and residues on Turkish 

bay leaves and just cited EPA tolerance levels for pesticides on herbs subgroup 19A. 

Based on the availability of organic sources, the NOSB recommended at its October 2015 meeting to 

remove Turkish bay leaves from 205.606. In an August 7, 2017 final rule, USDA noted it received public 

comments opposing the remove of Turkish bay leaves from the National List. These extensive comments 

stated that Turkish bay leaves are not available in the quantity or quality needed to meet organic 

handling needs. Comments explained that while organic whole bay leaf may be commercially available, 

ground organic bay leaves provide a different flavor profile, are not presently commercially available, 

and removal of Turkish bay leaves from the National List would negatively impact finished products 

containing ground bay leaves. Comments requested that USDA maintain the allowance for nonorganic 

Turkish bay leaves while suppliers pursue sources of ground organic Turkish bay leaves in sufficient 

quality and quantity to meet industry needs. 

In response to these comments, USDA determined that nonorganic forms of Turkish bay leaves are 

essential to organic production and handling and should remain on the National List. At the time of this 

decision, USDA noted that organic handlers are permitted to use the nonorganic substance only if the 

organic substance is not commercially available. Handlers need to demonstrate, and certifiers need to 

verify, that the organic substance is not available in the form, quality or quantity needed. 

In a December 2019 review of the Organic Integrity Database, the Handling Subcommittee found 62 

records of certified handlers and crop producers listing “bay leaf,” 86 records listing “bay leaves,” and 

four records listing “Turkish bay leaves.” 

During its Spring 2020 review, the Handling Subcommittee heard overwhelming support to remove 

Turkish bay leaves from the National List. As noted above and attested to in public comments received, 

there appears to be a sufficient quantity of organic Turkish bay leaves in the market to support this 

removal. Of the certifiers that submitted comments on §205.606 sunset materials, only one noted the 

inclusion of nonorganic Turkish bay leaves in 4 organic system plans. One trade association noted one 

organic operation they surveyed used Turkish bay leaves in a wide range of canned soups but stated 

there is full availability of organic forms. The operation further noted there would be no impact from 

removal of this material because organic forms can be used and are available. 

Based on these comments and the apparent wide availability of organic sources, the Handling 

Subcommittee recommends the removal of Turkish bay leaves from §205.606 of the National List. 

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Subcommittee Vote: 

Motion to remove Turkish bay leaves from §205.606 of the National List based on the following criteria 

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

Motion by: Scott Rice 

Seconded by: Steve Ela 

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

Whey protein concentrate 

Reference: 205.606(w) Whey protein concentrate. 

Technical Report: 2015 TR 

Petition(s): 2007 Petition 

Past NOSB Actions: 05/2007 NOSB recommendation; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation 

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

renewal notice published 07/06/17 (82 FR 31241) 

Sunset Date: 6/27/2022 

Subcommittee Review: 

Use: 

Whey protein concentrate is used in dairy products, protein bars, and infant formulas. Whey protein 

concentrate is used as a source of protein, as a fat replacer, and as a texturizer. 

Manufacture: 

Whey protein concentrate is a soluble fraction of bovine milk composed of protein, minerals, and 

lactose and is a byproduct of cheese manufacturing. The primary method of production mixes milk with 

rennet to coagulate the casein to make cheese curds, the resulting liquid is whey. Another method of 

production is via microbiological fermentation or direct addition of lactic acid that acts to reduce the pH 

and coagulate the casein. The whey undergoes an ultra-filtration process to remove a large portion of 

the lactose and minerals. Low temperature processing ensures retention of both nutritional and 

functional properties. Whey protein concentrate is evaporated then spray-dried and sold as a dry 

ingredient. The whey protein concentrate may also be bleached with hydrogen peroxide or benzoyl 

peroxide. Whey protein concentrate can be concentrated to different protein levels (i.e., 35%) but max 

out around 80%. Concentrations higher than 90% are considered whey protein isolate. 

International: 

Whey protein concentrate is not specifically listed in the CODEX, Canadian, or Japanese organic 

standards. “Whey powder ‘herasuola’” is listed on the EU Organic Standards. 

Ancillary Substances: 

Soy lecithin may be added as an "instantizing" ancillary substance. 

Environmental Issues and Human Health Impacts: 

In most jurisdictions, environmental regulations now prevent disposal of untreated whey on agricultural 

land or discharging in municipal sewage system or surface water. Whey composition (high solids, 

lactose and salt content) makes disposal practices a problem. Rodenberg, 1998 reported that the five 

day biochemical oxygen demand (BOD5) is a measure of the organic pollutant concentration in the 

wastewater, and is proportional to the amount of milk or whey lost to the sewer (TR lines 629-631). 

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Normal dairy production plant wastewater is in the range of 2000 to 3000 mg/l which is 10 times the 

strength of domestic sewage. The BOD5 can go much higher if a milk spill occurs and the pH can 

fluctuate widely if spent cleaning in place chemicals are discharged as well. Dairies manage their 

wastewater discharge to avoid upsetting their biological treatment process or a publicly owned 

treatment system. With recent advances in technology, as well as increasing awareness of the 

environmental and financial costs of whey disposal, the dairy industry has found it profitable to process 

whey into high value added protein products for use as ingredients in food systems. Whey proteins are 

generally recognized as safe (GRAS) and are considered a label-friendly ingredient. A large portion of the 

energy used at a typical cheese making operation is devoted to processing whey powder or concentrate. 

Falling-film type evaporation systems are used to concentrate whey liquid. To fully dry the whey to a 

powder form, condensed whey from an evaporator is fed to a spray dryer. Both of these processes are 

highly energy intensive due to the thermal energy required. 

Subcommittee Review: 

During the Board’s previous review in 2015, the NOSB requested information from the public related to 

(1) ancillary substances, (2) commercial demand, (3) commercial availability, (4) other alternatives, and 

(5) use in the industry. In the past, one public comment was received from a certifier on the use of soy 

lecithin as an ancillary substance. No information was provided on commercial demand, alternatives or 

its use in the industry. One trade association commented on its essentiality and lack of supply but 

provided no detailed information on why the supply identified by the NOSB was insufficient. One 

certifier noted they have clients producing and selling organic whey protein concentrate. Given the 

availability of organic whey protein concentrate and the absence of information on continued 

commercial unavailability from industry, the Handling Subcommittee recommended this item be 

removed from the National List in 2015 (2015/Fall - Rec to Remove). To date, NOP has not removed 

WPC from the National List. A petition to remove whey protein concentrate from the National List 

(https://www.ams.usda.gov/sites/default/files/media/Addendum1_PetitionforRemovalofWheyProteinC 

oncentrate_2019.pdf) is currently under review by the Handling Subcommittee, and review of the 

Organic Integrity Database indicates several suppliers of whey protein concentrate. 

Public comments received during the Spring 2020 NOSB were overwhelmingly in support of removing 

whey protein concentrate from the National List. The Handling Subcommittee specifically requested 

information as to whether there were any forms of whey protein concentrate that were not available 

organically. In response to this explicit request, no public comments were received indicating that there 

were organic forms that were not available. Furthermore, several commenters replied that they had 

adequate supply of all forms and actually had so much supply that they were having to sell some organic 

product on the conventional market. These comments included: 

CROPP Cooperative: Organic Whey Protein is fully available in form and volume. The processing 

infrastructure has grown dramatically since whey protein concentrate was placed on the 

National List. Processors are established throughout the United States for both finished 

products and condensed whey. Roughly sixty percent of our whey is processed into whey 

powders, with future plans to utilize our entire whey stream. Our whey supply could produce 

1.4 million pounds of WPC annually. Today there is an ample supply of organic whey protein 

concentrate on the market and the supply will continue to grow. In fact, our WPC supply is 

greater that market demand, where large volumes of our supply are sold on the conventional 

market. 

Western Organic Dairy Producers: We have more than adequate product available to meet the 

current demand for Organic Whey Protein Concentrate. Given this availability, there is no need 

to utilize a conventional product for products labeled as organic. The removal of the 

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conventional Whey Protein Concentrate further supports organic dairy producers and organic 

dairy product utilization. 

Milk Specialties Global: As outlined in the petition, the decision to allow nonorganic whey in 

organic products may have been necessary in 2007, but no longer meets the threshold of 

necessity today. We urge the NOSB to remove Whey Protein Concentrate from the National List 

as part of the mandated sunset process. 

Furthermore, at least one organic certifier notes that all of their handlers are currently using organic 

forms of whey protein concentrate and a number of suppliers were identified on the Organic Integrity 

Database. Another commenter also noted that organic whey-based products are also offered from 

international partners, making the supply chain quite robust. 

As noted above, the NOSB has also received a petition to remove whey protein concentrate from the 

National List. The reasoning given in the petition is similar to the reasons listed above. There is 

adequate organic supply. Despite questions that have been directed towards identifying any forms that 

are not available organically, there has been no public comment received indicating that the organic 

supply is inadequate. In fact, there has been comment that at this point the supply exceeds the 

demand. For this reason the Handling Subcommittee recommends removing whey protein concentrate 

from the National List. 

Subcommittee Vote: 

Motion to remove whey protein concentrate from §205.606 of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Alternatives (availability of 

organic whey protein concentrate), 7 U.S.C. 6518(m)(6) 

Motion by: Steve Ela 

Seconded by: Jerry D’Amore 

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

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National Organic Standards Board 

Crops Subcommittee Petitioned Material Discussion 

Whey Protein Concentrate 

August 10, 2020 

Summary of Petition (Original petition 9/30/19; petition addendum #1 12/2/19; petition addendum 

#2 3/21/20): 

A petition to remove whey protein concentrate from the National List was received by the NOSB on 

September 30, 2019. This petition was received at the same time the NOSB is conducting the sunset 

review for whey protein concentrate. The reasons for removal in the petition are similar to the reasons 

cited by the handling subcommittee in its recommendation to remove this material through the sunset 

process. There is adequate organic supply of both form and quantity. Given the commercial availability 

of organic why protein concentrate, this material no longer appears to meet the criteria for inclusion on 

the National List as defined in the Organic Foods Production Act, (7 U.S.C 6518(m)(6)). 

Summary of Review: 

In response to questions to stakeholders requesting if there are any forms not available organically, no 

public comment received indicated that the organic supply is inadequate. In fact, comments detailed 

the organic supply, both in quantity and form, exceeds the organic demand. As noted above, the 

Handling Subcommittee has recommended whey protein concentrate be removed from the National 

List. For a complete description of the review of whey protein concentrate, please refer to the Handling 

Subcommittee’s fall 2020, sunset review for this material. 

The Handling Subcommittee has decided to defer action on this petition until the actions on the sunset 

review are final. If the NOSB votes to delist whey protein concentrate as part of the sunset process and 

rulemaking for delisting becomes final, the need for this petition is moot and the petition could be 

withdrawn. However, if in light of new public comment that a specific form or forms of whey protein 

concentrate are not available and the sunset vote or rulemaking does not result in delisting of this 

material, the NOSB could resume work on this petition. The petition process could allow for annotation 

whereby the NOSB could determine that whey protein concentrate be delisted except for a specific form 

or forms that the NOSB might determine are not available organically. 

Public comments received during the Spring 2020 NOSB were overwhelmingly in support of removing 

whey protein concentrate from the National List. The Handling Subcommittee specifically requested 

information as to whether there are any forms of whey protein concentrate that are not available 

organically. In response to this explicit request, no public comments indicated that there are organic 

forms that are not available. Furthermore, several commenters replied that they had an adequate 

supply of all forms and actually had so much supply that they were having to sell some organic product 

on the conventional market. These comments included: 

CROPP Cooperative: Organic Whey Protein is fully available in form and volume. The processing 

infrastructure has grown dramatically since whey protein concentrate was placed on the 

National List. Processors are established throughout the United States for both finished 

products and condensed whey. 

Roughly sixty percent of our whey is processed into whey powders, with future plans to utilize 

our entire whey stream. Our whey supply could produce 1.4 million pounds of WPC annually. 

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Today there is an ample supply of organic whey protein concentrate on the market and the 

supply will continue to grow. In fact, our WPC supply is greater that market demand, where 

large volumes of our supply are sold on the conventional market. 

Western Organic Dairy Producers: We have more than adequate product available to meet the 

current demand for Organic Whey Protein Concentrate. Given this availability, there is no need 

to utilize a conventional product for products labeled as organic. The removal of the 

conventional Whey Protein Concentrate further supports organic dairy producers and organic 

dairy product utilization. 

Milk Specialties Global: As outlined in the petition, the decision to allow nonorganic whey in 

organic products may have been necessary in 2007, but no longer meets the threshold of 

necessity today. We urge the NOSB to remove Whey Protein Concentrate from the National List 

as part of the mandated sunset process. 

Furthermore, at least one organic certifier noted that all of their handlers are currently using organic 

forms of whey protein concentrate and a number of suppliers were identified on the Organic Integrity 

Database. Another commenter also noted that organic whey-based products are also offered from 

international partners, making the supply chain quite robust. 

Questions: 

1. The NOSB received a number of public comments at the Spring, 2020 public meeting that there 

is an adequate supply of organic whey protein concentrate to meet all the market demands for 

this material. To best inform its final sunset review decision at its Fall 2020 meeting, the Board 

is interested in hearing feedback on the following questions. Are there any specific forms of 

organic whey protein concentrate that are not available in organic form or quantity? 

2. Are there any reasons that there is not an adequate organic supply of whey protein concentrate 

to meet the market demand? 

Subcommittee Vote: 

Motion to accept the discussion document on whey protein concentrate 

Motion by: Steve Ela 

Seconded by: Scott Rice 

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

Approved by Asa Bradman, Handling Subcommittee Chair, to transmit to NOP August 13, 2020 

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National Organic Standards Board 

Livestock Subcommittee Petitioned Material Proposal 

Fenbendazole 

July 21, 2020 

Summary of Petition: 

In July 2019, the NOSB received a petition requesting a revision to the annotation at 7 CFR §205.603 

(23)(i) to include the use of Fenbendazole for laying hens and replacement chickens intended to become 

laying hens. 

The targeted organisms of Fenbendazole are the parasitic roundworms Ascaridia galli and Heterakis 

gallinarum. Chickens infected with A. galli and H. gallinarum become unthrifty, weak and emaciated and 

exhibit weight loss proportional to the parasite load. Young birds are more susceptible to the parasites 

than are mature hens, but mature hens will exhibit significant loss of egg production when infected with 

A. galli and H. gallinarum. 

Histomoniasis, also known as Blackhead Disease, is a disease caused by infection with Histomonas 

meleagridis. The disease was named “blackhead disease” because one of the common symptoms 

observed in infected birds is a bluish or blackish appearance of the skin on their face, comb and wattles. 

The discoloration occurs because of excessive concentration of reduced hemoglobin in the blood or 

cyanosis. Flocks of laying hens frequently are infected during the late summer and fall, following heavy 

rainfall. This is due to the association of earthworms, who commonly surface from the soil after heavy 

rains. If the chickens eat earthworms which carry the cecal worm, Heterakis gallinarum, they will 

indirectly become infected themselves. 

Fenbendazole is an antiparasitic drug that works at the sub-cellular level preventing cell division. 

Benzimidazoles bind to the β-tubulin, inhibiting the cell’s microtubule assembly responsible for 

intracellular transport and required for mitotic cellular division. (McKellar and Scott 1990). In effect, it 

starves the parasite by causing intestinal cell disruption. Studies conducted by Sander and Schwarz 

1994; Yazwinski and Tucker 2008, Yazwinski et al, 2013, and Alvardo and Mozisek 2018 showed that the 

late-stage larvae and adult stages of A. galli and H. gallinarum treated with Fenbendazole showed 

significantly increased mortality, but hens treated with Flubendazole passed viable eggs that was not 

significantly decreased in numbers. According to the Merck Veterinary Manual, “The wide safety margin 

of benzimidazoles is due to their greater selective affinity for parasitic β-tubulin than for mammalian 

tissues.” (Merck, 2006) 

Fenbendazole was first approved in 1983 for use in cattle, including beef animals and dairy cows, as a 

treatment and control of several types of gastronomical worms, including: lungworms, stomach worms 

(brown stomach worm, barberpole worm and small stomach worm), and intestinal worms (hookworm, 

threadnecked intestinal worm, small intestinal worm, bankrupt worm, and nodular worm). 

A request was submitted to FDA by Ivervet, Inc. to expand the use of Fenbendazole to chickens. The FDA 

determined that the ADI (Acceptable Daily Intake) in humans is 40 ug/kg of body weight per day and the 

tolerance for Fenbendazole is 1.8 ppm expressed as the metabolite fenbendazole sulfone. In October 

2015, the FDA gave formal approval for the use of Fenbendazole in treatment and control of adult A. 

galli in broiler chickens and replacement chickens intended to become breeding chickens and for the 

treatment and control of adult A. galli and H. gallinarum in breeding chickens. The FDA allowed a total 

of 2.4 ppm residual of Fenbendazole in eggs with no withdrawal time from application. 

On January 15, 2018, the approval was extended for the use of Fenbendazole under the trade name of 

AquaSol for the treatment and control of adult A. galli in broiler chickens and replacement chickens and 

for the treatment and control of adult A. galli and H. gallinarum in breeding chickens and laying hens. 

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Fenbendazole was approved to be administered to conventional laying hens and replacement hens at 

the following rates: 

• 200 mg of fenbendazole/ml for oral administration via drinking water 

• Safe-Guard® AquaSol must be administered orally to chickens via the drinking water at a daily 

dose of 1.0 mg/kg BW (0.454 mg/lb.) for 5 consecutive days. 

Conventional poultry producers typically administer Fenbendazole to pullets (age 17 weeks of age) or 

before outdoor access is given to birds to ensure birds have no internal parasites before starting egg 

production. When birds receive access to the outdoors they come into contact with soil and in turn 

come into contact with internal parasites. Many producers find the need to re-treat their flocks after a 

period when birds have access to the soil and come into contact with many internal parasites. 

Organic Summary: 

In May 2012, Fenbendazole was added to the National List for use in organic livestock, as specified at 7 

CFR § 205.603: 

In 2016 the NOSB recommended that the annotation for Fenbendazole be amended to include the 

following: 

• That parasiticides continue to be prohibited in slaughter stock. 

• That the milk withholding period after treatment with fenbendazole be changed from 90 days to 

2 days for dairy cows, and 36 days for goats and sheep. 

• That fleece and wool from fiber bearing animals be allowed to be certified organic even if use of 

parasiticides was necessary at some time in the animal’s life. 

• That fenbendazole be allowed without written order of a veterinarian. 

On Jan 28, 2019: The NOP issued a final rule: 

Paragraph (a)(23)(i) is revised to read as follows: Fenbendazole (CAS #43210-67-9)—milk or milk 

products from a treated animal cannot be labeled as provided for in subpart D of this part for: 2 

days following treatment of cattle; 36 days following treatment of goats, sheep and other dairy 

species. 

In addition, paragraph (b)(2) of § 205.238(b) is revised and paragraph (b)(3) is added to

§ 205.238(b) as follows: (b)(2) Dairy animals, as allowed under § 205.603; and (b)(3) fiber bearing 

animals, as allowed under § 205.603. AMS has reviewed and agrees with the NOSB

recommendation that § 205.238(b) be amended to clarify its use of parasiticides for dairy animals

and for fiber bearing animals. 

In Spring 2018, the NOSB recommended clarifying “Emergency” for use of synthetic parasiticides in 

organic livestock production. The following language was recommended for a rule change: 

Emergency treatment to allow synthetic parasiticide use in livestock: A livestock emergency is an 

urgent, non-routine situation in which the organic system plan’s preventive measures and veterinary 

biologics are proven, by laboratory analysis or visual inspection, to be inadequate to prevent lifethreatening illness or to alleviate pain and suffering. In such cases, a producer must administer the 

emergency treatment (§205.238(c)(7)). Organic certification will be retained, provided that such 

treatments are allowed under § 205.603 and the organic system plan is changed to prevent a 

similar livestock emergency in individual animals or the whole herd/flock in future years as required 

under §205.238(a).

Add this to § 205.238 (b)(4) Organic livestock as provided in §205.238 (b) (1), (2), and (3) and only in

the event of an emergency where management strategies have been proven insufficient to prevent 

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or control parasites within the accepted threshold for specific parasites, age and species of the 

animal. These management strategies include but are not limited to, grazing systems and living 

conditions that prevent infestation and re-infestation, forage height diversity, use of allowed nonsynthetic botanicals, biologics and minerals to maintain parasite levels below treatment thresholds, 

and could include monitoring and documentation of parasites through use of methods such as fecal 

monitoring and FAMACHA.

(23) Parasiticides—prohibited in slaughter stock, allowed in emergency treatment for dairy and 

breeder stock when organic system plan-approved preventive management does not prevent 

infestation. 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. 

Allowed for fiber bearing animals when used a minimum of 36 days prior to harvesting of fleece or 

wool that is to be sold, labeled, or represented as organic. 

(i) Fenbendazole (CAS #43210-67-9)—milk or milk products from a treated animal cannot be labeled 

as provided for in subpart D of this part for: 2 days following treatment of cattle; 36 days following 

treatment of goats, sheep, and other dairy species. 

In Fall 2019, the NOSB Livestock Subcommittee reviewed the petition to expand the annotation to allow 

Fenbendazole for use on laying hens and replacement chickens intended to become laying hens and 

submitted a discussion paper at the Fall 2019 NOSB meeting. Based on public comments from the Fall 

2019 NOSB meeting, the Subcommittee requested a technical report (TR) limited specifically to the use 

of Fenbendazole in laying hens and replacement chickens intended to become laying hens. The 

Livestock Subcommittee gave ten specific focused questions to the TR team concerning human health 

issues and regulatory issues, and asked the TR team to research any effective alternative methods to the 

use of Fenbendazole in controlling A galli and H. gallarinum worms in laying hens and replacement 

chickens intended to become laying hens. 

A second discussion paper was submitted by the NOSB in Spring 2020 to elicit more public comments on 

amending the 7 CFR 7 CFR §205.603 (23)(i) annotation to allow fenbendazole for use in laying hens and 

replacement chickens intended to become laying hens. 

Summary of Public Comments 

The NOSB Livestock Subcommittee received many public comments during the Fall 2019 and Spring 

2020 NOSB meetings. 

• Many of the public comments were focused on human health concerns resulting from the FDA 

allowance of 2.4 ppm residual of Fenbendazole in eggs when there is no withdrawal time. Some 

questioned the method that FDA used to determine the safety of the 2.4 ppm residual of 

Fenbendazole in eggs. One commenter was concerned that spent laying hens might end up being 

used for slaughter in soups, etc. That concern is not valid as the current annotation prohibits the 

livestock from being used as slaughter animals after treatment with Fenbendazole. 

• Some public commenters stated their concerns that the definition of “Emergency” had not been 

adopted by the NOP. They stated that without “Emergency” being adopted the use of Fenbendazole 

in laying hens and chickens intended to become laying hens was “ripe for fraud.” 

• Some commenters stated that “small producers with hens given more access to pastures” did not 

have problems with worms. Other producers countered by stating that the problems with worms 

being presence in hens and their eggs has significantly increased since producers had shifted their 

practices to meet the increased demand for eggs from hens with humane certifications for Free 

Range or Pasture Raised production models which requires 2.0-108.9 square feet per bird of 

outdoor access. When birds are out grazing, they are scratching and digging in the dirt for worms 

and in return picking up intestinal parasites. 

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• Certifiers and OTA took surveys of their poultry producers to determine if amending the annotation 

to allow use for laying hens would be of benefit to them. Results of the surveys suggested that the 

producers were experiencing issues with worms in eggs and that having the use of Fenbendazole on 

an emergency basis would be one more tool for them to utilize when needed. Other certifiers 

stated their clients were not having problems with worms in eggs. 

Technical Review Summary 

The TR addressed the specific questions asked by public commenters and the NOSB Livestock 

Subcommittee. 

• Health issues concerning the 2.4 ppm residual of Fenbendazole in eggs with no withdrawal 

period. The TR states that the ADI was established by the FDA based on extrapolation from 

adverse health effects found in a six-month oral toxicity study that fed Fenbendazole fed to 

laboratory dogs. Prior to the FDA’s 2018 approval of Fenbendazole for use in laying hens, the 

detection of any Fenbendazole residues in eggs was considered a violation (Marmulak et al. 2015). 

The TR found that infants and children are considered at a greater risk from exposure to veterinary 

drug residues than adults, because of their lower weight, growth and developmental stage which 

many risk assessment models do not include. The study also indicated increased risks to pregnant 

women and fetuses exposed to the drug (Boobis et al. 2017). In a study of food safety risks, 

Fenbendazole was rated as having a medium likelihood of occurrence (Bobkov and Zbinden 2018). 

In one human health study, five adult males were fed the equivalent of 2,500 eggs and 5,000 eggs 

respectively. There were no relevant changes in blood pressure, pulse rate, symptom list, selfrating scale, and clinical chemistry. (Rupp and Hajdu 1974, reported in Inchem 1998). 

Human trials were conducted in 1976 to determine whether Fenbendazole would be considered as 

treatment for human hookworms and pinworms. Fenbendazole was found to be effective with 

minor side effects of constipation and burning when urinating. Nevertheless, since that time 

Fenbendazole has not commonly been used to treat human infestations. 

Benzimidazoles (Fenbendazole) have been used as cancer chemotherapy agents and has been 

studied as a potential anti-cancer agent (Duan et al. 2013). Development of Fenbendazole is still in 

relatively early stages. Nothing was found in the scientific literature to suggest Fenbendazole 

residues in eggs would interfere with its use as a cancer treatment. 

• Fenbendazole Amounts in Eggs and Poultry 

The question was asked whether cooking eggs at the recommended cooking temperatures of 144-

158 F would eradicate the Fenbendazole residuals. The TR found that Fenbendazole fully degrades 

with peaks of 222.76 F, 447.24 F, 654.66 F and 862.07 F, all considerably higher than eggs are 

normally cooked for consumption. 

• Natural Alternatives to using Fenbendazole 

Organic livestock producers have historically and traditionally used a wide range of botanical and 

naturopathic remedies to control worms in poultry. One common natural remedy is the use of 

Diatomaceous Earth fed to the birds. The TR provided a table of several substances and 

methodologies historically used. Most but not all remedies are derived from plants commonly 

found in the U.S. The TR states that these remedies do not have efficacy or safety data on file with 

the FDA and are not labeled for internal use on animals. Many of these botanical remedies do not 

have scientific evidence of their efficacy and safety specifically to poultry internal parasites. At 

least one organic parasite management guide questions the scientific evidence supporting the 

efficacy of homeopathic remedies. 

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Studies show that sanitation of poultry runs is crucial. Pastures, yards and pens should be rotated 

frequently. It is not clear how long the rotation period in the runs is needed to break the parasitic 

cycle. Worm eggs may survive in pastures for over two years, and in some experiments, rotations 

did not significantly reduce infestation rates. Some studies indicated that DE could more 

effectively be applied to the litter as ovicides to prevent re-infestation of the parasites rather than 

fed in the poultry feed. The use of probiotics is showing some promise of helping eradicate the 

worm populations in poultry. 

The TR concludes that there is very little research looking at the effectiveness of the natural practices 

used by organic farmers to control worm populations. The efficacy and safety of these treatments are 

based largely on anecdotal information and not supported by peer-reviewed scientific research. 

Category 1: Classification 

1. Substance is for: _______ Handling ____X___ Livestock 

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: 

b. If the substance is Non-agricultural, is the substance _____ Non-synthetic or __X__ 

Synthetic? 

c. 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 Fenbendazole was included in the March 2007 petition requesting 

the addition of Fenbendazole as an approved material under §205.603(a)(23)(i) of the National List. 

The Fenbendazole in AquaSol is now further processed whereby it is reduced in particle size to 

create a more stable suspension in drinking water. This further processing subjects the 

Fenbendazole to a wet-milling process whereby a 40 percent fenbendazole suspension is 

recirculated between a mixing vessel and wet-mill. Utilizing a rotating axis and milling beads, the 

wet-mill subjects the Fenbendazole particles to impaction and sheer forces, reducing the particle to 

a submicron size. Moreover, at the end of the manufacturing process Panacur AquaSol is a 20 

percent Fenbendazole suspension whereas Panacur Suspension 10% (Safe Guard in the US) is a 10 

percent suspension. 

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? 

Fenbendazole is petitioned as a parasiticide. 

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)] 

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Fenbendazole is insoluble in water and excreted after administration in feces. Because it is not 

soluble, there is little mobility of fenbendazole in soils, and a low risk of groundwater 

contamination. Laboratory tests show that radiolabeled fenbendazole is degraded with a halflife of 54 days. Although photo-degradation plays a role, degradation of fenbendazole in soil 

appears to be microbially dependent rather than photodegradative (Kreuzig et al., 2007). 

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)] 

Fenbendazole toxicity was demonstrated in pigeons and doves leading the authors of the study 

to suggest a toxic etiology for fenbendazole in birds of the order Columbiformes treatment 

(Howard et al., 2002). 

The fate of Fenbendazole in manure and manured soils has been studied under laboratory and 

field conditions. In pig manure, benzimidazoles disappear slowly. After a 102-day incubation 

period, 80% Fenbendazole remains. The latter was accompanied by 4% of the corresponding 

metabolite fenbendazole-sulfoxide. Fenbendazole-sulfoxide remains in clay soil samples after 54 

days (Kreuzig et al., 2007). 

Excreted Fenbendazole and Ivermectin residues in cattle dung pats do not significantly affect 

adult dung beetles or adult dipteran flies; however, excreted Ivermectin produces toxic effects 

on the larval development of the same dung-colonizing families of insects, while Fenbendazole 

lacks such toxic effects (Strong et al., 1995). 

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. 

3. Describe the probability of environmental contamination during manufacture, use, misuse or 

disposal of such substance? [§6518(m)(3)] 

Fenbendazole is manufactured by a process that requires petrochemicals such as benzene and 

various amines. These are considered toxic compounds. 

4. Discuss the effect of the substance on human health. [§6517 (c)(1)(A)(i); §6517 (c)(2)(A)(i); 

§6518(m)(4)]. 

Fenbendazole is not generally considered toxic to humans at regulated doses (FDA, 1995). 

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)] 

Fenbendazole is insoluble in water, is not a leachate, binds tightly to soil and is not expected to 

migrate in soil. The only route for fenbendazole to enter the environment is through animal 

excretion or spillage. Fenbendazole degrades in soil through microbial and photodegradative 

processes, taking up to 60 days (Hoechst-Roussel Agrivet, 1995) 

6. Are there any adverse impacts on biodiversity? (§205.200) 

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Fenbendazole can break into albendazole. However, there is a low likelihood of physiologic 

effects. (pg 5 TAP) 

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)] 

While diatomaceous earth (DE) is utilized widely and effectively as a control for external 

parasites, its effectiveness as an internal control has not been reputably documented. 

Diatomaceous earth has no effect on lungworm and is not very appetizing to poultry. It may also 

be a lung irritant. Given that the level of dust is already quite high in barns, diatomaceous earth 

does not seem appropriate when the animals are fed indoors. The main motivation for adding 

diatomaceous earth to rations should not be to control internal parasites. 

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)] 

Parasiticide use has been tolerated in organic livestock production on a limited basis to alleviate 

animal suffering. This has almost been, without exception, part of an integrated system of 

animal health management and requires documentation of a number of approaches other than 

intervention. 

National List Motion: 

Motion to amend the listing for fenbendazole to include: Fenbendazole-for use in laying hens or 

replacement chickens intended to be laying hens at 7 CFR §205.603 (23)(i). 

Motion by: Sue Baird 

Seconded by: Kimberly Huseman 

Yes: 4 No: 2 Abstain: 0 Absent: 0 Recuse: 0 

Approved by Sue Baird, Livestock Subcommittee Chair, to transmit to NOP July 22, 2020 

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Sunset 2022 

Meeting 2 - Review 

Livestock Substances §205.603, §205.604 

October 2020 

Introduction 

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

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

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

National List for use in organic livestock production that must be reviewed by the NOSB and renewed by 

the USDA before their sunset dates. This document provides the substance’s current status on the 

National List, use description, references to past technical reports, past NOSB actions, and regulatory 

history, as applicable. If a new technical report has been requested for a substance, this is noted in this 

list. To see if any new technical report is available, please check for updates under the substance name 

in the Petitioned Substances Database. 

Request for Comments 

Written public comments will be accepted through October 1, 2020 via www.regulations.gov. 

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

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Sunset 2022 

Meeting 2 - Review 

Livestock Substances §205.603, §205.604 

October 2020 

Reference: 7 CFR 205.603 Synthetic substances allowed for use in organic livestock production 

Butorphanol 

Flunixin 

Magnesium hydroxide 

Poloxalene 

Formic Acid 

EPA List 4 - Inerts of Minimal Concern 

Excipients 

Livestock 205.604 Prohibited nonsynthetic substances 

Strychnine 

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Butorphanol 

Reference: §205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(5) Butorphanol (CAS #-42408-82-2) - federal law restricts this drug to use by or on the lawful written or 

oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food 

and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires: 

(i) Use by or on the lawful written order of a licensed veterinarian; and 

(ii) A meat withdrawal period of at least 42 days after administering to livestock intended for slaughter; 

and a milk discard period of at least 8 days after administering to dairy animals. 

Technical Report: 2002 TR 

Petition(s): 2002 Petition 

Past NOSB Action: 2002 Livestock Subcommittee recommendation; 09/2002 Meeting minutes and vote; 

04/2010 sunset recommendation; 10/2015 sunset recommendation 

Recent Regulatory Background: National List Amended 12/12/2007 (72 FR 7049); Sunset renewal notice 

published 06/06/12 (77 FR 33290); Sunset renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Butorphanol is used in livestock production as a pre-operative treatment of pain before surgery. 

Butorphanol belongs to a general class of drugs known as opiate agonists. It is commonly used as an 

anesthetic used to treat patients prior to surgery. Other related drugs in this class include buprenorphine, 

fentanyl, merperidine, and morphine. Xylazine, acepromazine, and butorphanol serve similar functions but 

each has its own specific advantages that make it the preferred treatment at the time: acepromazine has 

no analgesic activity, it is only a sedative; xylazine has both analgesic and sedative properties; and 

butorphanol is a pain killer with no real sedative activity” (TAP p24.) Although, “there are non-synthetic 

opiates (refers to a group of drugs used for treating pain), butorphanol is preferred for several reasons: it is 

associated with fewer adverse effects for the animal; it has less abuse potential in humans thereby 

reducing unwanted consequences if the drug is “diverted” to illicit use.” 

Manufacture: 

Butorphanol is an opioid analgesic derived from morphine. Known for the ability to reduce the perception 

of pain without a loss of consciousness, the original opioids were derived from opium, which is a partially 

dried latex harvested from the opium poppy, Papaver somniferum. 

International Acceptance: 

Canadian General Standards Board Permitted Substances List 

Table 5.3 of the Permitted Substances List includes butorphanol under the entry for botanical compounds, 

noting it shall be used according to label specifications. 

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

Organically Produced Foods (GL 32-1999) 

While butorphanol is not specifically listed, the standard states that when veterinary drugs are used, the 

withholding period shall be twice the period of conventional standards. 

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

Article 14 notes that “suffering shall be kept to a minimum during the entire life of the animal, including at 

the time of slaughter.” The regulation further notes “disease shall be treated immediately to avoid 

suffering to the animal; chemically synthesized allopathic veterinary medicinal products including 

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antibiotics may be used where necessary and under strict conditions, when the use of phytotherapeutic, 

homeopathic and other products is inappropriate. In particular restrictions with respect to courses of 

treatment and withdrawal periods shall be defined.” 

Japan Agricultural Standard (JAS) for Organic Production 

While butorphanol is not specifically listed, the standard states that when veterinary drugs are used, the 

withholding period shall be twice the period of conventional standards. 

International Federation of Organic Agriculture Movements (IFOAM) Norms 

While butorphanol is not specifically listed, the general principles state management practices should be 

directed to the well-being of animals, achieving maximum resistance against disease and preventing 

infections. Sick and injured animals must be given prompt and adequate treatment. Further, the standards 

note the well-being of the animals is the primary consideration in the choice of illness treatment. The use 

of conventional veterinary medicines is allowed when no other justifiable alternative is available. 

Withdrawal periods shall not be less than double of that required by legislation. 

Ancillary substances: 

Butorphanol tartrate includes sodium chloride, sodium citrate, and citric acid. 

Environmental Issues: 

Impacts of manufacture of butorphanol are unknown (TAP p25.) Butorphanol is used by injection. 

Butorphanol and metabolites are not considered toxic if released. Although the fate of butorphanol in the 

environment is not known, the metabolites that are excreted via urine and bile are water-soluble which 

will not likely accumulate in the local environment. Butorphanol disposal in city water drainage/sewer 

systems is accepted practice (TAP pp19, 25). 

Discussion: 

Butorphanol has been FDA approved for use as an anesthetic in non-food animals. Its use in food animals is 

an extra-label use (ELU) governed by the Animal Medicinal Drug Use Clarification Act, which allows animal 

drugs to be used for ELUs when, “limited to treatment modalities when the health of an animal is 

threatened or suffering, or death may result from failure to treat.” The material must be administered by a 

licensed veterinarian. If all precautions are followed and the drug is administered appropriately, the NOSB 

judged that there will be no harm done to humans who consume the meats from these animals—and the 

livestock are able to tolerate surgery, recover quickly, and grant the farmer economic satisfaction, 

according to the 2002 TAP. 

The withdrawal periods for butorphanol in the organic regulations are twice those in the Food Animal 

Residue Avoidance Databank (FARAD). FARAD is a university-based national program that serves as the 

primary source for scientifically-based recommendations regarding safe withdrawal intervals of drugs and 

chemicals in food-producing animals. 

In its last review, the NOSB judged butorphanol to be consistent with consumer perceptions of organic 

products. The NOSB’s 2002 votes were 11 favored, 1 absent, and 2 abstained and the NOSB’s 2010 vote 

was unanimous to retain this material on the NL. 

Comments received generally supported the continued listing of butorphanol. Two dairy organizations, one 

dairy cooperative, and one former NOSB member commented in favor of continued use. One organization 

requested that the LS determine the impacts of the metabolites of butorphanol in milk and when excreted; 

and determine the legality of the use under the Animal Medicinal Drug Use Clarification Act (AMDUCA), 

since labels prohibit the use in food-use animals. With regard to the legality of the use and the presence of 

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butorphanol and its metabolites in milk, USDA did determine that butorphanol is listed in the Food Animal 

Residue Avoidance Databank (FARAD), and the listed meat withdrawal and milk discard times are twice 

those listed in FARAD (2007 FR Notice). With regard to the impacts of the excreted metabolites, the TAP 

review did not consider them problematic. 

However, reliance on AMDUCA’s exemption of ELUs can be problematic (Wren, 2008), and at the time of 

last review, the Livestock Subcommittee encouraged the Food and Drug Administration to address these 

uses directly through labeling. 

During its first review at the April 2020 meeting, the Board received a majority of comments that support 

butorphanol’s continued listing. Certifiers provided data that shows a small number of operations using 

this, but several conveyed its importance as a veterinary medicine tool. Several dairy and dairy 

organizations advocated for its continued listing to ensure the welfare of their animals and the safety of 

their vets during procedures. As noted in the last sunset review, one organization indicated that 

information in the TAP about impacts of butorphanol and its metabolites when excreted were not covered 

and that additional info would be helpful to understand any impacts that may exist. The commenter 

proposes that all metabolites be evaluated, as well as the extra-label use as described in the discussion 

above. Xylazine was noted as an alternative but with a caveat that it is not effective. 

Based on the comments received, the Livestock Subcommittee considers butorphanol to still be an 

important veterinary tool for organic producers and supports its relisting at this time. 

Subcommittee Vote: 

Motion to remove butorphanol from §205.603 of the National List based on the following criteria in the 

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

Motion by: Scott Rice 

Seconded by: Dan Seitz 

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

Flunixin 

Reference: §205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(12) Flunixin (CAS #-38677-85-9)—in accordance with approved labeling; except that for use under 7 CFR 

part 205, the NOP requires a withdrawal period of at least two-times that required by the FDA 

Technical Report: 2007 TAP 

Petition(s): N/A 

Past NOSB Actions: 10/2002 NOSB recommendation; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation 

Recent Regulatory Background: National List Amended 12/12/2007 (72 FR 7049); Sunset renewal notice 

published 06/06/12 (77 FR 33290); Sunset renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Flunixin, in its compounded state called flunixin meglumine is a potent, non-narcotic, nonsteroidal 

analgesic agent with anti-inflammatory and antipyretic activity. Flunixin, in its drug form, Banamine®, exists 

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for intravenous or intramuscular use in horses and for intravenous use in beef and non-lactating dairy 

cattle only to treat inflammation and pyrexia. 

Banamine® has been used to rapidly reduce the fever and lung inflammation that typically accompany 

Bovine Respiratory Disease (BRD). As a result of usage, cattle feel better faster and have fewer lung lesions 

in comparison to treatment with other remedies. Additionally, Banamine® has been used to reduce 

inflammation associated with endotoxemia. 

If all precautions are followed and the drug is administered appropriately, there will be no harm done to 

humans who consume the meats from these animals - and the livestock are able to cope with the disorder 

and actually heal from it, quickly recovering, and granting the farmer economic satisfaction. 

Manufacture: 

Flunixin is a synthetic drug more commonly made into flunixin meglumine, which is the primary 

component of Banamine® (the injectable flunixin meglumine solution). It has been FDA approved and used 

in horses for intravenous or intramuscular injections and as intramuscular injections for beef and nonlactating dairy cattle for many years to help cope with inflammation, pyrexia, and colic. Administered 

intravenously and intramuscularly, flunixin is quickly broken down internally and cleared from the 

bloodstream in urine 

Flunixin meglumine is a potent inhibitor of the enzyme cyclooxygenase and is often classified as a nonsteroidal anti-inflammatory drug (NSAID) and it functions by reducing the production of mediators of the 

inflammatory process. It acts as an anti-inflammatory by inhibiting the effect of prostaglandins by 

inhibiting cyclooxygenase (COX), the enzyme responsible for the direct synthesis of prostaglandins. 

International Acceptance: 

Canada - Canadian General Standards Board Permitted Substances List: 

http://www.tpsgc-pwgsc.gc.ca/ongc-cgsb/programme-program/normes-standards/internet/bioorg/permises-permitted-eng.html. Flunixin is permitted in Table 5.3 as inflammatories. Preference shall be 

given to non-synthetic alternatives to reduce inflammation. 

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

http://www.organic-world.net/news-eu-regulation.html; http://eurlex.europa.eu/LexUriServ/site/en/oj/2007/l_189/l_18920070720en00010023.pdf. Flunixin does not 

explicitly appear in the EU Council Regulation, EC No. 834/2007 or 889/2008. However, EC No. 889/2008 

Section 4, Article 24 permits the use of chemically synthesized, allopathic veterinary treatments (including 

antibiotics) when phytotherapeutic, homeopathic products, trace elements and products listed in Annex V, 

part 3 and in Annex VI, part 1.1 are ineffective. Flunixin is a drug that has been specifically approved for 

use in swine. 

Japan Agricultural Standard (JAS) for Organic Production; 

http://www.ams.usda.gov/nop/NOP/TradeIssues/JAS.html 

Flunixin does not explicitly appear in the Japanese Agricultural Standard for Organic Livestock Production; 

(Notification No. 1608); however, Article 4 allows the use of veterinary drugs including biological drugs and 

antibiotics. Article 3 defines three types of drugs and incorporates by reference other Japanese laws 

pertinent to animal health care and drugs. 

International Federation of Organic Agriculture Movements (IFOAM) 

http://www.ifoam.org/standard/norms/cover.html Flunixin does not explicitly appear in the IFOAM 

NORM (Version 2014). However, Section 5.6 permits the use of chemical allopathic medical products when 

natural and alternative medicines and treatments are unlikely to be effective. Vaccines are also permitted 

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in some cases. The norm also states that operators shall give preference to natural medicines, including 

homeopathy, Ayurvedic medicine and acupuncture. 

Environmental Issues: 

Generally, flunixin has been declared fairly safe and the probability of environmental contamination during 

use or disposal of flunixin is very low. EPA stated in a report on PPCP (Pharmaceuticals and Personal Care 

Products) that are found in the environment, particularly in the water, flunixin was not among the other 

NSAIDs (i.e. aspirin, ibuprofen, etc.) that had residues left in the waters. 

The Spring 2020 Public Comments were overwhelmingly supportive of keeping Flunixin on the National 

List. Several certifiers conducted surveys of their clients and reported to the NOSB that their clients used 

Flunixin on their operations and desired to keep it in their ‘toolbox” to use when needed for their 

livestock’s well-being. Based on prior Subcommittee review and public comments, the NOSB found 

flunixin compliant with OFPA criteria, and does not recommend removal from the National List. 

Subcommittee Vote: 

Motion to remove flunixin from §205.603 of the National List based on the following criteria in the Organic 

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

Motion by: Sue Baird 

Seconded by: Dan Seitz 

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

Magnesium hydroxide 

Reference: §205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(18) Magnesium hydroxide (CAS #-1309-42-8)—federal law restricts this drug to use by or on the lawful 

written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 

of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, the NOP requires use 

by or on the lawful written order of a licensed veterinarian. 

Technical Report: 2007 TR 

Petition(s): 2002 Petition 

Past NOSB Actions: 2002 NOSB recommendation; 11/2005 NOSB sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Magnesium hydroxide is used as an antacid for temporary relief of an upset stomach and as a laxative for 

short-term relief of constipation. Magnesium hydroxide is used as a flame retardant and smoke depressant 

for temperatures exceeding 400 degrees Fahrenheit. It is also a general food additive used as a colorretention agent, drying agent, pH control agent, or processing aid. Magnesium hydroxide is also used as a 

fertilizer (in the form of lime) as a substitute for more expensive chemical fertilizers. 

Manufacture: 

The TR states magnesium hydroxide (Brucite) is found naturally in serpentine, chlorite or dolomitic schists, 

or in crystalline limestones as an alteration product of periclase (magnesium oxide). It is prepared by 

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mixing sodium hydroxide with a water-soluble magnesium salt. It is also formed by the hydration of 

reactive magnesium oxide. Either case produces a white precipitate. 

International Acceptance: 

IFOAM: Basic standards 2002- not explicitly listed as approved food additive or processing aid. 

CODEX: Magnesium hydroxide meets the requirements set forth in the Food Chemical Codex, 3rd ed. 

Assuming good manufacturing practices, magnesium hydroxide is recognized as an acceptable, safe food 

ingredient. 

NORWAY: Magnesium hydroxide is listed as a chemical requiring a much-reduced discharge rate, despite 

the full known toxicology of the compound. The discharge of unused chemicals is strictly forbidden and 

enforced in Norway. 

The European Union (EU) and the US vary greatly in their limitations on sludge and how it should be 

treated to prevent disease in livestock. The EU allows more freedom when considering how sludge will be 

used for treatment. The US requires disposal classification of the sludge before it can be used for 

treatment. Magnesium hydroxide/oxide are listed as permitted substances in the EU standards. 

JAPAN: not specifically listed in Japanese Rule. 

Environmental Issues: 

According to the TR, the EPA has deemed magnesium hydroxide environmentally safe. This assessment is 

based on toxicology reports provided by the Centers for Disease Control. Magnesium hydroxide is not 

listed on the EPA’s list of regulated chemicals. 

Subcommittee Review: 

Based on the Subcommittee review and public comment, the Livestock Subcommittee finds magnesium 

hydroxide compliant with OFPA criteria and does not recommend removal from the National List. 

Subcommittee Vote: 

Motion to remove magnesium hydroxide from §205.603. 

Motion by: Jesse Buie 

Seconded by: Kim Huseman 

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

Poloxalene 

Reference: §205.603(a) As disinfectants, sanitizer, and medical treatments as applicable 

(26) Poloxalene (CAS #-9003-11-6)—for use under 7 CFR part 205, the NOP requires that poloxalene only 

be used for the emergency treatment of bloat 

Technical Report: 2001 TAP 

Petition(s): 2000 Petition 

Past NOSB Actions: 03/2001 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

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Subcommittee Review: 

Use: 

Poloxalene (chemical formula: C5H10O2) is a copolymer of polyethylene and polypropylene ether glycol that 

is a non-ionic polyol surface-active agent. Poloxalene is a fast-acting synthetic material approved under the 

organic regulations only for emergency treatment of bloat. In conventional agriculture, it is also used 

medically as a fecal softener and in cattle for prevention of bloat. 

Manufacture: 

According to the 2001 NOSB TAP review of poloxalene, “There are two principal processes used [to 

manufacture poloxalene] the traditional chlorohydrin process and indirect oxidation by the hydroperoxide 

process that uses a molybdenum catalyst. Both processes start with propylene (propene) derived from 

cracking of petroleum. The chlorhydrin process involves reaction of propylene (CH3CH=CH2) and chlorine 

in the presence of water to produce two isomers of propylene chlorhydrin. This is followed by 

dehydrochlorination using caustic soda or lime to produce propylene oxide and salt. The hydroperoxide 

process involves oxidation of propylene to PO by an organic hydroperoxide, producing an alcohol as a coproduct. One of the possible alcohols (tert-butanol, TBE) produced as a by-product from this process is 

used as feedstock for MTBE, a gasoline additive. (Kirk-Othmer 1996b)” 

International acceptance: 

• Poloxalene is not mentioned specifically in the Codex Alimentarius; however, the Codex states that 

in certain defined circumstances “veterinary drugs or antibiotics may be used under the 

responsibility of a veterinarian” provided that “withholding periods [are] double of that required 

by legislation with, in any case, a minimum of 48 hours.” 

• Poloxalene is not mentioned in specifically the Canadian standards; however, “the standards 

encourage the use of alternative treatments (e.g., homeopathy and herbal treatments) over 

regular veterinary drugs. However, if the animal is not responding to alternative treatments or if 

alternatives are known to be ineffective, the use of antibiotics, parasiticides and other medications 

is allowed with the additional restrictions outlined here. ‘Chemical, allopathic veterinary drugs’ 

refer to synthetic drugs used in mainstream veterinary practice.” 

• The Japanese Agricultural Standard for Organic Livestock etc. does not specifically mention 

poloxalene; however, like the Codex and Canadian standards, the is some allowance for use of 

allopathic veterinary drugs when organic approaches are not effective. 

• According to the 2001 TAP: 

o EU 2092/91 – Similar to Codex, with an additional proviso that animals treated more than 

2 times or maximum of 3 times per year with chemical veterinary drugs can no longer be 

marketed as organic (Annex I, Section B 4). 

o IFOAM – similar to Codex and EU, natural products and preventive methods preferred, but 

use of veterinary medicines is permitted under control of certification agency. 

Ancillary substances: 

No clear information on ancillary substances was available. 

Environmental/Health Issues: 

According to the 2001 TAP review, “The production of organic polymers from petroleum sources is a large 

volume chemical manufacturing process that has significant environmental impact.” The 2001 TAP also 

states that the “FDA does not list any withdrawal times or residue tolerances for poloxalene. (21CFR)” and 

also the following in regard to human health: “Poloxalene is listed by USP for use as pharmeuceutic aid. It 

is reported to have no known toxicity (Winters, 99) and is not listed in the National Toxicology Program 

Database.” 

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Discussion: 

The 2001 TAP review stated that “Clearly, there are many preventive measures that can be taken to avoid 

pasture bloat. Organic farmers seeking to establish a pasture based system for ruminants may occasionally 

experience unforeseen incidence of pasture bloat that requires an emergency remedy. Use of this 

synthetic material could be justified to alleviate animal suffering on a very occasional basis.” 

The following was the conclusion stated in the 2001 TAP review: “Poloxalene is clearly synthetic and 

prohibited unless added to the National List for medical use. The TAP reviewers are divided and do not 

have a consensus recommendation. Two of the reviewers favor its allowance for emergency use only 

based on a need to prevent suffering and promote animal welfare. The third reviewer finds the rare 

emergency use not to be a compelling reason for considering as a permitted synthetic and does not see it 

as indispensable given that other treatments are available for cases of mild bloat, and other emergency 

treatments are called for in life threatening circumstances. This is supported by the lack of historic 

allowance, or demonstrated need by existing certification agencies. The two reviewers who favor limited 

allowance also suggested either an extended withdrawal time, or a limited allowance for a permitted 

number of emergency treatments per year for organic animals. No data to support an extended 

withdrawal time has been presented, but the NOSB may want to consider an overall policy for frequency of 

emergency treatment or develop criteria for emergency use medication in general.” 

Altogether, about a dozen written comments on poloxalene were submitted prior to the April 2020 NOSB 

meeting. The large majority of comments either supported continued listing of the substance as necessary 

in emergencies when natural approaches to treating bloat are not effective, or stated that the substance 

was used by organic farming operations for emergency situations. The general consensus was that while 

poloxalene is rarely needed, in certain emergency situations it is essential. Two commenters stated that 

the NOSB should not relist poloxalene unless there is strong evidence of need; however, these 

commenters did not offer any conclusions in this regard. 

Based on the comments received, the Livestock Subcommittee considers poloxalene to still be an 

important veterinary tool for organic producers and supports its relisting at this time. 

Subcommittee Vote: 

Motion to remove poloxalene from §205.603(a) of the National List based on the following criteria in the 

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

Motion by: Dan Seitz 

Seconded by: Nate Powell-Palm 

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

Formic acid 

Reference: §205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable 

(3) Formic acid (CAS # 64-18-6) - for use as a pesticide solely within honeybee hives 

Technical Report: 2011 TR 

Petition(s): 2010 Petition 

Past NOSB Actions: 2010 NOSB recommendation; 10/2015 sunset recommendation 

Recent Regulatory Background: Added to National List, effective August 3, 2012 (77 FR 45903); Sunset 

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

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Subcommittee Review: 

Use: 

Formic acid is a pesticide employed to control Varroa and tracheal mites in honeybee hives. Deployed in 

the form of a compressed pad inside the hive, the material volatilizes to kill mites throughout the hive 

including mites attacking broods, and located externally on and internally in the adult bees. 

The EPA first registered formic acid as a pesticide in 1999 as material control for Varroa and tracheal mites 

in honeybees. Formic acid kills mites by asphyxiation while not causing harm to the bees. Typically 

employed over a 21-day treatment period (per label instructions), the efficacy of formic acid in killing mites 

has been found to be as high as 95%. Label recommendations instruct producers who treat hives with 

formic acid to not harvest honey from the hive for two weeks after the introduction of the formic acid 

pads. 

Natural sources of formic acid, which include coffee, nectars, some fruits, as well as the stings of ants and 

bees, have proven insufficient to extract commercially viable quantities. 

Manufacture: 

Primarily produced through the hydrolysis of methyl formate. Formic acid may be produced as a byproduct 

of other chemicals (e.g. acetic acid) though these have not proven to be commercially viable. 

International Acceptance: 

Canada: The Canadian Organic Standards require a 30-day withdrawal time. Also allowed for use silage 

preservation. 

European Economic Community: Formic acid is allowed to control Varroa mites in honeybees. Also 

allowed for use in silage preservation. 

FDA: Formic acid is generally recognized as safe GRAS (21CFR 186.1316) 

Environmental Issues: 

Due to its localized use inside the beehives, no residue is found outside the hive environment. Human 

health may be adversely affected if formic acid is inhaled or ingested. Respirators and skin covering 

personal protective equipment is recommended to protect against applicator contact. 

Subcommittee Vote: 

Motion to remove formic acid at § 205.603 (b) of the National List based on the following criteria in the 

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

Motion by: Nathaniel Powell-Palm 

Seconded by: Scott Rice 

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

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EPA List 4 —Inerts of Minimal Concern 

Reference: §205.603(e) As synthetic inert ingredients as classified by the Environmental Protection Agency 

(EPA), for use with non-synthetic substances or synthetic substances listed in this section and used as an 

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

(1) EPA List 4 - Inerts of Minimal Concern 

Technical Report: 2015 Limited Scope TR Nonylphenol Ethoxylates (NPEs) (one group only of List 4 inerts) 

Petition(s): N/A 

Past NOSB Actions: 02/1999 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

EPA List 4 Inerts are used for a wide range of applications including surfactants and adjuvants in pesticide 

formulations. 

Manufacture: 

As this listing covers a wide range of substances, manufacture varies. 

International: 

Since this listing covers many different materials, a specific listing of international acceptance cannot be 

provided. However, it is worth pointing out how other standards address inerts. 

Canadian General Standards Board Permitted Substances List 

The Permitted Substances List does not individually list inerts, or “formulants” as noted in the Canadian 

text. Formulants as a class are not subject to the restrictions and prohibitions in the standard. 

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

Organically Produced Foods (GL 32-1999) 

While section 5 outlines criteria for the inclusion of substances, the guidelines do not specifically address 

or include inerts. 

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

The regulation does not specifically address the use of inerts. 

Japan Agricultural Standard (JAS) for Organic Production 

The standard does not specifically address the use of inerts. 

International Federation of Organic Agriculture Movements (IFOAM) Norms for Organic Production and 

Processing 

Section 3.1 of the norms state organic crop production ensure co-formulants (e.g. inerts) in formulated 

farm input products are not carcinogens, mutagens, teratogens or neurotoxins. 

Ancillary Substances: 

Given the wide range of substances, presence of ancillaries will vary. 

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Environmental Issues: 

Some of the materials listed on List 4 may have negative environmental and human health consequences, 

while others may be relatively benign. A complete review of materials listed as to environmental issues is 

not possible without Technical Reviews of each material. 

Discussion: 

While the EPA categorized lists (1, 2, 3, 4, 4A, 4B) provided guidance for evaluation of inert substances in 

organic production, these lists are no longer updated and have limited utility. The NOSB has devoted 

considerable time to discussing and debating how to address the placement of inerts on the National List. 

A comprehensive timeline authored by Terry Shistar of Beyond Pesticides is included in the Crops 

Subcommittee’s EPA List 4 Inerts sunset review. 

The Inerts Working Group (IWG), made up of NOSB members and NOP and EPA staff, was established in 

June 2010 and reported to the Crops Subcommittee. The group collected information regarding current 

classification of the former List 3 and 4 inerts and presented a discussion document at the November 2011 

NOSB meeting. At that time, the NOSB and the IWG were working toward a solution to review the inerts 

that were formerly on EPA List 4 by collaborating with the Safer Choice Program (SCP) of the EPA. 

In 2015, the Crops Subcommittee requested a Technical Report (TR) on the class of inerts known as 

Nonylphenol Ethoxylates (NPEs). The Livestock Subcommittee also reviewed this TR as part of the 2017 

Sunset review of the EPA List 4 Inerts of Minimal Concern listed at §205.603. As highlighted in the TR, the 

US EPA is encouraging industry to eliminate the use of NPEs (TR 2015, line 137) because of toxicity 

concerns and persistence in the environment. It is unlikely that the NPEs would pass favorably through the 

SCP screening process. The Crops and Livestock Subcommittees have considered removing NPEs through 

an annotation, while maintaining the general listing for EPA List 4 while the new SCP review program starts 

up. 

Because of concerns about the adverse health and environmental effects of NPEs, the SCP completed an 

alternatives assessment for synthetic surfactants, like NPEs, that are not endocrine disrupting chemicals. 

SCP’s goal was to assist in the voluntary phase-out of NPEs used in industrial detergents. The SCP 

assessment for NPEs reviewed several alternatives to NPE surfactants that are comparable in cost, readily 

available, and rapidly biodegrade to non-polluting, lower hazard compounds in aquatic environments. 

Since this assessment, many formulators have reformulated their products without the use of NPEs. 

The Crops Subcommittee drafted a proposal outlining the steps for implementation of the Safer Choice 

Program for inert review. Once initiated, inert manufacturers would have to submit their products to Safer 

Choice to be reviewed. A long implementation phase would be proposed, so that industry and 

manufacturers have enough time for submittal of inerts for screening and any required formulation 

change. The Livestock and Crops Subcommittees have noted that some inerts currently in use in organic 

products would likely not pass the Safer Choice review, and strongly encourage manufacturers to consider 

the likelihood of the need for reformulation. 

Past public comments at sunset weighed heavily in favor of robust reviews of inert ingredients, due in large 

part to the fact that the original listing of inerts relied upon an EPA screening process which does not 

consider the OFPA criteria. Additionally, public comments indicated significant concern that, while inerts 

are not listed as active ingredients in many pesticide formulations, they nevertheless exert significant 

impact on the environment, terrestrial and aquatic ecosystems and human health. The Livestock 

Subcommittee recognizes the public’s deep concerns regarding these materials, while also acknowledging 

the significant impact that wholesale removal of EPA List 4 Inerts from the National List would have on the 

organic industry. 

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In the last two sunset reviews, the Board has voted to retain the listing of EPA List 4 Inerts while the 

organic industry, the NOP, and the EPA worked together to create a path forward that adequately reviews 

inerts for compatibility with organic production. In October 2015, the Board passed a recommendation 

proposing an annotation to remove the reference to EPA List 4, and move forward with a formal 

relationship to work with the EPA Safer Choice Program. The recommendation acknowledges the current 

nomenclature in use by the EPA regarding FIFRA 25(b) and 40 CFR 180.1122, while laying a framework for 

some inerts to be reviewed individually. 

To date, the 2015 recommendation has not been implemented. The 2015 recommendation presents 

options for moving forward that are still relevant and necessary. The board strongly encourages the NOP 

to move forward on this recommendation and add it to the regulatory agenda. 

During the spring 2020 comment period, the Board again heard overwhelmingly from stakeholders that 

the inertia around this issue is unacceptable. As one comment noted, “It has now been five years since 

NOP committed to implementing the NOSB recommendation; ten years since EPA directly requested NOP 

to remove the reference in its regulations; and about 15 years since EPA Lists became obsolete. Yet the 

NOP regulations still refer to EPA Lists that were last updated in August 2004.” Commenters expressed 

support for removing the reference in the annotation to EPA List 4 Inerts and moving the 2015 

recommendation forward. Several comments provided detailed steps for how the NOP, NOSB and EPA 

Safe Choice Program can work together to accomplish this. 

Though a path forward is well-defined, the timeline required to enact the 2015 recommendation is likely a 

lengthy one. Many EPA List 4 inerts used in compliant crop and livestock input formulations also appear on 

the EPA Safer Chemicals Ingredient List (SCIL), thus providing a viable transition to this more relevant list. 

Other inputs with inerts of known toxicity or other concerns would not move to the SCIL list and require 

reformulation and the subsequent registration and approval that is required of new regulated inputs. 

Ultimately, the reformulation of inputs to safer ingredients is a positive direction in which to move, one 

which meets consumer expectations and strengthens the integrity of the organic label. However, removal 

of the EPA List 4 reference with no immediate substitute will in the interim cause potential disruption to 

organic operations that rely on materials formulated with these inerts, removing essential tools in an 

already limited toolbox. 

With these concerns recognized, the Subcommittee on a whole is hesitant to recommend removing EPA 

List 4 at 205.603(e) from the National list. However, we are unanimous in our request that the NOP 

immediately initiate steps to implement the 2015 NOSB recommendation to use the Safer Chemical 

Ingredient List for inerts as an evaluative tool in an expedited manner where possible. It is the intent that 

the NOP and NOSB work, as recommended by this Board in 2015, with EPA’s Safer Choice Program and 

move to evaluate inerts in a manner that fulfills the requirements laid out in the Organic Foods Production 

Act. 

Subcommittee Vote: 

Motion to remove EPA List 4—Inerts of Minimal Concern from §205.603 of the National List based on the 

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

Motion by: Scott Rice 

Seconded by: Sue Baird 

Yes: 2 No: 4 Abstain: 0 Absent: 0 Recuse: 0 

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Excipients 

Reference: §205.603(f) Excipients—only for use in the manufacture of drugs and biologics used to treat 

organic livestock when the excipient is: (1) Identified by the FDA as Generally Recognized As Safe; (2) 

Approved by the FDA as a food additive; (3) Included in the FDA review and approval of a New Animal Drug 

Application or New Drug Application; or (4) Approved by APHIS for use in veterinary biologics. 

Technical Report: 2015 TR 

Petition(s): N/A 

Past NOSB Actions: 10/2002 NOSB minutes and vote; 10/2010 sunset recommendation; 10/2015 sunset 

recommendation 

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

notice published 03/21/2017 (82 FR 14420); Sunset renewal notice published 12/27/2018 (83 FR 66559) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

There are more than 8,000 food, drug, and cosmetic excipients available for conventional production; 

however, excipients currently appear in the USDA National Organic Program (NOP) regulations at §205.603 

for use in the manufacture of drugs used to treat organic livestock when the excipient is identified by the 

FDA as: 1) Generally Recognized As Safe (GRAS); 2) approved by the FDA as a food additive; 3) included in 

the FDA review and approval of a New Animal Drug Application or New Drug Application; or 4) Approved 

by APHIS (Animal and Plant Health Inspection Service) for use in veterinary biologics. Additionally, 

excipients are allowed in “nutritive supplements” listed at § 205.603(a)(21). 

Excipients are defined in §205.2 as “any ingredients that are intentionally added to livestock medications 

but do not exert therapeutic or diagnostic effects at the intended dosage, although they may act to 

improve product delivery (e.g., enhancing absorption or controlling release of the drug substance).” 

Excipients are used in New Animal Drug Applications (NADAs) approved by FDA, and in animal health care 

products that do not carry NADA registration. They are also used in New Drug Applications (NDAs) in drugs 

marketed for human consumption that may be administered to animals, such as aspirin. 

Excipients are used for a great number of applications in animal drug and health care products but are 

delineated into broad categories based on the major reasons the excipient is used. “Examples of such 

ingredients include fillers, extenders, diluents, wetting agents, solvents, emulsifiers, preservatives, flavors, 

absorption enhancers, sustained- release matrices, and coloring agents.” (§ 205.2) 

Manufacture: 

Excipients are common in almost all therapeutic products for veterinary use, and in some cases the total 

amount of excipients used is greater than the active substances in the dose. They are derived from natural 

sources or are synthetically manufactured by chemicals, derived from genetically modified organisms, or 

manufactured by other means. They range from simple, whole food products, to highly characterized 

organic and inorganic molecules, to complex materials that are difficult to fully characterize chemically. 

Excipients can be added to the active substance individually or together in a formulated excipient package, 

depending on the drug. Excipients serve many functions but are typically comprised of suspending and 

viscosity-modifying agents, pH modifiers and buffering agents, preservatives, antioxidants, chelating 

agents, sequestrants, colorants, flavors, fillers, and diluents. While it is clear the functions that excipients 

serve, very few of them have been chemically described in any detail (TR- 54-56). 

Because excipients are manufactured for a wide variety of purposes, the source and origin are highly 

variable. They range from whole food products such as wheat middlings and yeast to synthetic food 

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additives such as sodium benzoate and sodium lauryl sulfate. They may be agricultural, non-synthetic or 

synthetic. Some are extracted or produced from plants, animals, minerals or microorganisms, and others 

are manufactured entirely from chemicals. 

International Acceptance: 

Canada - Canadian General Standards Board Permitted Substances List: http://www.tpsgcpwgsc.gc.ca/ongc-cgsb/programme-program/normes-standards/internet/bio- org/permises-permittedeng.html Excipients are permitted under the Canadian Organic Standards, appearing in Table 5.3 as 

Formulants (inerts, excipients), and can only be used in conjunction with substances listed in Table 5.3. 

The listing in Table 5.3 does not specify any criteria for further compliance of such excipients. 

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

Organically Produced Foods (GL 32-1999) 

ftp://ftp.fao.org/docrep/fao/005/Y2772e/Y2772e.pdf 263 Excipients do not explicitly appear in the tables 

of permitted substances for organic livestock production; however, the use of veterinary medicinal 

products is permitted under certain conditions according to Health Care, Section 22, including chemical 

allopathic drugs. Excipients are not specifically mentioned in this section. 

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

http://www.organic-world.net/news-eu-regulation.html; http://eurlex.europa.eu/LexUriServ/site/en/oj/2007/l_189/l_18920070720en00010023.pdf 271. 

Excipients do not explicitly appear in the EU Council Regulation, EC No. 834/2007 or 889/2008. However, 

EC No. 889/2008 Section 4, Article 24 permits the use of chemically synthesized, allopathic veterinary 

treatments (including antibiotics) when phytotherapeutic, homeopathic products, trace elements and 

products listed in Annex V, part 3 and in Annex VI, part 1.1 are ineffective. 

Japan Agricultural Standard (JAS) for Organic Production 

http://www.ams.usda.gov/nop/NOP/TradeIssues/JAS.html 

Excipients do not explicitly appear in the Japanese Agricultural Standard for Organic Livestock Production; 

(Notification No. 1608); however, Article 4 allows the use of veterinary drugs including biological drugs and 

antibiotics. Article 3 defines three types of drugs and incorporates by reference other Japanese laws 

pertinent to animal health care and drugs. 

International Federation of Organic Agriculture Movements (IFOAM) 

http://www.ifoam.org/standard/norms/cover.html Excipients do not explicitly appear in the IFOAM 

NORM (Version 2014). However, Section 5.6 permits the use of chemical allopathic medical products when 

natural and alternative medicines and treatments are unlikely to be effective. Vaccines are also permitted 

in some cases. The norm also states that operators shall give preference to natural medicines, including 

homeopathy, Ayurvedic medicine and acupuncture. 

Environmental Issues: The primary mechanism through which excipients appear in the environment is via 

manure application to cropland. There is little known about the actual effects, adverse or not, on the 

environment from excipients. Only a handful of studies have even identified the presence of specific 

excipients in the environment, while most studies focus on pharmaceuticals without making a distinction 

between active and excipient ingredients. Since most excipients used in organic livestock production are 

GRAS or FDA approved food additives, the potential for environmental and human health effects has been 

evaluated by the FDA as part of their legal status. No literature was found to show definitive harmful 

effects on the environment when excipients are used in animal health care products. 

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On the other hand, there are environmental concerns related to the manufacture of excipients. Because of 

the great variety of substances permitted for use as excipients and the methods of manufacture, some of 

the excipients could have detrimental environmental effects. Raw material extraction of petroleum 

products, solvents and mined minerals pose negative environmental effects; the FDA has gone as far as 

recommend to the pharmaceutical industry to avoid certain solvents (e.g., benzene, carbon tetrachloride, 

1,2-dichloroethane, 1,1-dichloroethane, 1,1,1-trichloroethane) that pose exceptional environmental and 

human health risks. Further processing of certain ingredients like starches and starch derivatives can lead 

to environmental degradation, air pollution, and exploitation of resources. A great number of excipients 

may be derived from GMOs; i.e., soy, corn, cotton, etc. 

Health Issues: 

There is no literature to indicate specific human health effects through the use of excipients in livestock 

health care products; but there is significant literature to show that certain excipients can have detrimental 

and even lethal consequences when administered directly to human beings, especially infants. This is one 

reason the FDA assesses the safety of excipients as part of each NADA application, rather than individually 

in a separate program. New excipients undergo a series of preclinical tests recommended by FDA and the 

International Pharmaceutical Excipients Council that include acute oral and dermal toxicity, teratology, 

genotoxicity assays, and skin sensitization studies in rodents. These tests may be conducted on the 

excipient in combination with the active ingredient, or as a stand-alone ingredient. 

The most likely route of exposure of humans to excipients in animal drugs is through consumption of 

residues in milk and meat products of treated animals. Most of the research on contamination has focused 

upon traces of antibiotics, but formulations specifically allowed in §205.603 can also appear in milk and 

meat. Presumably, both the active ingredient and the excipients are cleared from commercial products by 

the withdrawal times dictated by the NOSB on the active ingredients. However, since the majority of 

excipients used in organic livestock production are GRAS or food additives, the FDA assessment would 

include human and animal effects of ingestion of such ingredients, including their metabolism and 

breakdown pathways. Adulterated excipients pose some potential risk to human health; as a result, the 

FDA identified a partial list of excipients and active ingredients that may also be adulterated and need 

further testing. 

There were many comments from the public during the Spring 2020 NOSB meeting. Most of the 

comments addressed inconsistencies amongst certifiers about how to determine which excipients for 

livestock use are allowable and which are not. The NOSB was asked to commit to identifying and reviewing 

individual excipients to bring the clarity needed. 

Nevertheless, the NOSB heard resoundingly that the public desired that excipients remain on the National 

List. Several Certifiers sent results of surveys that they had conducted with their clients, and the results 

showed that the numbers of uses of excipients in livestock health products were in the thousands. 

Based on prior Subcommittee review and public comments, the NOSB found excipients compliant with 

OFPA criteria, and does not recommend removal from the National List. 

Subcommittee Vote: 

Motion to remove excipients from §205.603 of the National List based on the following criteria in the 

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

Motion by: Sue Baird 

Seconded by: Jesse Buie 

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

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Strychnine 

Reference: §205.604 Nonsynthetic substances prohibited for use in organic livestock production. 

The following nonsynthetic substances may not be used in organic livestock production: 

(a) Strychnine 

Technical Report: None 

Petition(s): N/A 

Past NOSB Actions: 04/1995 NOSB minutes and vote (crops only); 11/2005 sunset recommendation; 

10/2010 sunset recommendation; 10/2015 sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Strychnine is a toxic alkaloid that is a transparent crystal or white, crystalline powder. It was widely used in 

poison (toxic) baits to kill rodents and other mammals and is a common adulterant of many illicit (street) 

drugs. Exposure to strychnine can be fatal. It is colorless, odorless and has a bitter taste. 

Strychnine can be absorbed into the body by inhalation or ingestion. It can also be injected into the body 

when mixed with a liquid. Strychnine is rapidly metabolized and detoxified by the liver. This substance is 

also well-absorbed and acts very rapidly, producing muscular hyperactivity, which can quickly lead to 

respiratory failure and death. 

Strychnine has been placed in Toxicity Category I by the EPA, indicating the greatest degree of acute 

toxicity, for oral and ocular effects; inhalation toxicity is also presumed to be high. 

According to the USDA, above-ground uses were canceled in 1988; however, it remains registered for 

below-ground use to control damage caused by pocket gophers. 

Environmental Issues: 

According to the EPA, acute toxicity of strychnine to birds is assumed to be very high. Subacute dietary 

data indicate that strychnine ranges from slightly to highly toxic to avian species. Strychnine may pose a 

threat to birds who may be subject to repeated or continuous exposure from spills. 

Mammalian studies indicate that strychnine is very highly toxic to small mammals on both an acute oral 

basis and dietary basis. The signs of toxicity, including death, occurring within one hour. Acute freshwater 

fish data reveal that strychnine ranges from moderately to highly toxic to freshwater fish. Aquatic 

invertebrate acute toxicity data indicate that strychnine is moderately toxic to aquatic invertebrates. 

Discussion: 

In 2017, The Crops Subcommittee determined that strychnine did not meet the OFPA criteria and saw no 

reason to remove it from its prohibited status on the National List. Both the Crops Subcommittee and the 

full NOSB voted to not remove strychnine from § 205.604 - non-synthetic substances prohibited for use in 

organic crop production. 

Based on prior Subcommittee reviews and public comments, the NOSB found Strychnine non-compliant 

with OFPA criteria, and does not recommend removal from the National List §205.604. 

NOSB Proposals and Discussion Documents October 2020 130 of 173
 

Subcommittee Vote: 

Motion to remove strychnine from §205.604 of the National List based on the following criteria in the 

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

Motion by: Nathaniel Powell-Palm 

Seconded by: Jesse Buie 

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

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USDA National Organic Standards Board 

Research Priorities Proposal Fall 2020 

Executive Summary 

Overall: The National Organic Standards Board (NOSB) presents an annual list of research priorities for 

organic food and agriculture. The NOSB requests that integrated research be undertaken with 

consideration of the whole farm system, recognizing the interplay of agroecology, the surrounding 

environment, and both native and farmed species of plants and animals. 

Livestock 

1. Evaluation of methionine in the context of a system approach in organic poultry production. 

2. Prevention and management of parasites, examining breeds, geographical differences, alternative 

treatments, and pasture species. 

3. Organic livestock breeding for animals adapted to outdoor life and living vegetation. 

Crops 

1. Examination of decomposition rates, the effects of residues on soil biology, and the factors that 

affect the breakdown of biodegradable bio-based mulch film. 

2. Conduct whole farm ecosystem service assessments to determine the economic, social, and 

environmental impact of farming systems choices. 

3. Organic no-till practices for diverse climates, crops, and soil types. 

4. Develop cover cropping practices that come closer to meeting the annual fertility demands of 

commonly grown organic crops. 

5. Development of systems-based plant disease management strategies are needed to address 

existing and emerging plant disease threats. 

6. The demand for organic nursery stock far exceeds the supply. Research is needed to identify the 

barriers to expanding this market, then develop and assess organic methods for meeting the 

growing demand for organically grown nursery stock. 

7. Strategies for the prevention, management, and control of invasive insects and weeds. 

8. Factors impacting organic crop nutrition, and organic/conventional nutrition comparisons. 

9. Side-by-side trials of organic synthetic materials, natural materials, and cultural methods, with a 

request for collaboration with the IR4 project. 

10. Impartial evaluation of microbial inoculants, soil conditioners, and other amendments is needed as 

there is little objective evidence upon which to assess their contribution to soil health. 

11. More research, extension, and education are needed to fully understand the relationship between 

on-farm biodiversity and pathogen presence and abundance. 

12. Elucidate practices that reduce greenhouse gas emissions and that contribute to farming systems 

resilience in the face of climate change. 

Food Handling and Processing 

1. Evaluation of alternatives to chlorine materials in processing: impact mitigation, best 

management practices, and potential for chlorine absorption by produce. 

2. Suitable alternatives to BPA (Bisphenol-A) for linings of cans used for various products. 

Coexistence with GE and Organic Crops 

1. Outcome of genetically engineered (GMO/GE) material in organic compost. 

2. Evaluation of public germplasm collections of at-risk crops for the presence of GE 

traits, and ways to mitigate small amounts of unwanted genetic material in breeding 

lines. 

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3. Develop then implement methods of assessing the genetic integrity of crops at risk in 

order to quantify the current state of the organic and conventionally produced nonGMO seed. 

4. Techniques for preventing adventitious presence of GE material in organic crops, and 

evaluation of the effectiveness of current prevention strategies. 

5. Testing for fraud by developing and implementing new technologies and practices. 

General 

1. Examination of the factors influencing access to organically produced foods. 

2. Production and yield barriers to transitioning to organic production to help growers successfully 

complete the transition. 

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National Organic Standards Board 

Materials Subcommittee Proposal 

2020 Research Priorities 

Fall 2020 

INTRODUCTION 

The National Organic Standards Board (NOSB) presents an annual list of research priorities for organic food 

and agriculture. The NOSB’s Livestock, Crops, Handling, and Materials/GMO Subcommittees proposed an 

updated set of priorities at the Fall 2019 board meeting. That substantially updated list arose from public 

comments received by the NOSB and by concerns raised during the course of the Board’s work in the 

preceding year. Additional input since the Fall 2019 meeting further shaped the current list of research 

priorities. 

BACKGROUND 

The list of priorities is revisited each year by the NOSB. The list is made meaningful by input through the 

written and oral public comments shared with the Board, through the expertise of the Board itself and 

through interactions throughout the year with those engaged in some dimension of the organic farm to 

fork continuum. When the NOSB has determined that a priority area has been sufficiently addressed, it is 

removed from the list of priorities. Priorities are also edited each year to more accurately reflect the 

existing need for new knowledge. Three new research priorities were added in 2020 while others were 

significantly rewritten. 

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: 2020 RESEARCH PRIORITIES 

The NOSB encourages integrated, whole farm research into the following areas: 

Livestock 

1. Evaluation of Methionine in the Context of a System Approach in Organic Poultry Production -

Methionine is an essential amino acid for poultry. Prior to the 1950’s, poultry and pigs were fed a plant 

and meat-based diet without synthetic amino acids such as methionine. One former NOSB member 

stated, in §205.237(5) (b), “We have seemingly made vegetarians out of poultry and pigs”. As the 

organic community moves toward reducing, removing, or providing additional annotations to synthetic 

methionine in the diets of poultry, a heightened need exists for the organic community to rally around 

omnivore producers to assist in marshaling our collective efforts in finding viable alternatives to 

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

Continued research on the use of synthetic methionine in the context of a systems approach (nutrition, 

genetic selection, management practices, etc.) is consistent with the NOSB unanimous resolution 

passed at the La Jolla, California, Spring 2015 board meeting. A systems approach that includes industry 

and independent research by USDA/ARS, on farms, and by agricultural land grant universities is needed 

for (1) evaluation of the merits of natural alternative sources of methionine such as herbal methionine, 

high methionine corn, and corn gluten meal in organic poultry production systems; (2) evaluation of 

poultry breeds selection that could be adaptive to existing organic production systems – inclusive of 

breeds being able to adequately perform on less methionine; (3) assessment of management practices 

for improving existing organic poultry welfare under different conditions; and (4) and with the European 

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Union as a case study, assess how it is that EU farmers manage the methionine needs of their flocks in 

the absence of synthetic methionine use. Research findings and collaborations under various climates, 

housing types, geographical regions, and countries should be noted and researched, where applicable. 

Certainly, the fruition of these types of research topics could take years to achieve the expressed NOSB 

resolution; however, an aggressive and/or heightened research focus could lead to findings that can 

positively impact the organic poultry industry and the organic brand. The continued focus on 

methionine with a systems approach is imperative and necessary. The key research areas should include 

the efficacy and viability of alternatives such as: herbal methionine, corn gluten meal, potato meal, 

fishmeal, animal by-products, and other non-plant materials. Additional research on the more 

promising alternatives to bring them into commercial production is also encouraged. Additionally, 

management practices impacting the flock’s demand for methionine should be included, such as flock 

management practices, access to pasture, and pasture management. 

2. Prevention and Management of Parasites - Livestock production places large numbers of cattle, sheep, 

goats, poultry etc. into relatively close contact with each other on fields and in barns. Organic 

production does not allow antibiotic use and requires that livestock be raised in a manner which 

approximates the animal’s natural behavior. The organic farmer can use synthetic parasiticides in an 

emergency but not prophylactically. Synthetic parasiticides have many limitations. Even if prophylactic 

treatment with parasiticides were possible, it is clear that parasite immunity to chemical control will 

inevitably occur. Thus, prevention of parasites is critical. 

The research question on prevention and management of parasites must be systems based. What farm 

systems, bird and animal breeds, herd or flock management systems have shown the best results with 

parasite control over the last twenty years? What regional differences are there in the US in parasite 

prevention? Are there specific herbal, biodynamic, diatomaceous earth, or other treatments that have 

been proven to work overtime? What are the parasite-resistant breeds? Are there plant species in 

pastures, hayfields, and scrublands that could be incorporated into the annual grazing system to reduce 

the spread of parasites or to provide prevention through the flora, fauna, and minerals ingested? Which 

pasture management systems appear to be best for parasite prevention in various parts of the country? 

Are pasture mixes being developed that include plants known to prevent parasites in various breeds? 

3. Organic Livestock Breeding - Organic rules require livestock products originate from animals that are 

not confined and are adapted to outdoor living as well as obtaining feed from living vegetation. A 

current FAO report states that globally one third of pigs, half of all egg layers, two thirds of milk animals, 

and three quarters of meat chickens are produced with breeds more suited to confinement or 

“industrial” production systems than a typical organic farm or ranch. Similar to plant breeding, the 

organic community sees a great need for regionally-adapted and publicly available livestock breeds that 

can thrive in organic systems. Heritage, native regional breeds, and breeds used in the EU and other 

areas of the world that are typically more adapted to organic systems are still present but in small 

numbers. Increased research on the breeding, production needs, and improvement of these breeds is 

needed. Traits for good conversion rates from grazing and foraging to eggs, milk or meat, meeting 

consumer expectations for quality, as well as having the constitution and temperament to thrive 

outdoors would increase both the profitability and resiliency of organic livestock operations. Animal 

breeds that may have immunity to a variety of diseases and parasites would be useful traits to research 

and incorporate in a breeding program. 

Crops 

1. Biodegradable Bio-based Mulch Film - Biodegradable mulch was recently approved by the NOSB but 

did not specify a required percentage of biologically derived (i.e., bio-based) content. In 2015, NOP 

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issued a Policy Memo1 that states that certifiers and material organizations should review 

biodegradable mulch film products to verify that all (100%) of the polymer feedstocks are bio-based. 

This requirement makes bio-based mulches unavailable to organic producers because petroleum-based 

polymers are present in these mulch films. In order to provide a recommendation to the NOP 

addressing the presence of petroleum-based polymers in these mulches, the answers to the following 

questions are important to develop more clarity on mulch films and possibly develop an additional 

annotation to address producer needs for biodegradable mulch films even if petroleum-based polymers 

are used: 

• How rapidly do these mulches fully decompose, to what extent does cropping system, soil type, 

and climate mediate decomposition rates, and does the percentage of the polymers in the mulch 

film affect the decomposition rate? 

• Are there metabolites or breakdown products of these mulches that do not fully decompose? Do 

any of these mulches fully decompose? 

• Do breakdown byproducts influence the community ecology and ecosystem function of soils, 

plants, and the livestock that graze on crops grown in these soils? 

• As fragments degrade, do they pose a problem to terrestrial and aquatic wildlife? What are the 

environmental fates of micro- and nano-plastic fragments resulting from biodegradable mulch film 

degradation, and what hazards do they present to organisms that they interact with on the way to 

that fate? 

• Do the residues of these films accumulate after repeated use? 

• Are the testing protocols in place to insure decomposition standards? 

2. Ecosystem service provisioning and biodiversity of organic systems - How do organic systems impact 

ecosystem service provisioning, both on-farm and off-farm through the materials and inputs sourced 

and used for production? For example, life-cycle analysis of environmental costs and benefits of inputs 

used for organic production, such as manure, seaweed, and fish-based soil amendments, would be 

beneficial. Additionally, what is the impact of diversified and agroecologically designed organic farming 

systems on biodiversity and ecosystem services within the farm and in its surroundings? Can farmmapping be performed to quantify the impact of the location of a farm (in a broader landscape) and the 

arrangement of fields and non-crop habitat to enhance biodiversity and ecosystem service 

provisioning? 

3. Organic No-Till and Minimum Tillage - Organic no-till 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. 

Farmers are employing a number of different approaches to organic no-till. Some are using a rollercrimper to terminate cover crops for in-place mulching. They then transplant or seed directly into the 

cover crop mulch. Others are utilizing polyethylene sheets (silage tarps) to prepare land for no-till 

planting. This approach often involves termination of a cover crop, as with the roller-crimper systems, 

but seemingly as often, or more frequently, is utilized to prepare fallow ground (for stale seed bedding, 

termination of crop residue and subsequent incorporation via soil fauna), or in conjunction with large 

applications of compost or other sources of organic matter. 

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 notill practices. Research areas that could be covered include: 

1 Policy Memo 15-1 

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• Development of plant varieties that have specific characteristics, such as early ripening, to aid in 

the effectiveness and practicality of organic no-till. 

• What combination of mulch crops and cultural systems sustain crop yields, provide soil health 

benefits, and suppress weeds? 

• How does organic no-till influence pest, weed, and disease management? 

• What potential pest problems can be caused or exacerbated by cover crops used as mulches, and 

how can those problems best be managed? 

• In perennial cropping systems, such as fruits, what are the benefits or drawbacks of using this 

mulching system on weed, pest, and disease management, as well as soil fertility? 

• What are the biodiversity benefits to living and/or killed mulches, and how does this contribute to 

pest, weed, and disease management? 

• Do these systems affect the nutrient balance of the soil and subsequent fertilization practices, 

including use of outside inputs? 

• Based on the improved soil health, when there is less soil disturbance and more plant 

decomposition resulting in higher organic matter, how does this system affect soil microbial life 

and nutrient availability, and does this then result in crops that are less susceptible to disease and 

pests? 

• Research is needed on seeds, specifically for good cold germination, rapid emergence and 

establishment, seedling vigor, nutrient uptake efficiency, and overall weed competitiveness to crop 

cultivar development goals for organic conservation tillage systems. 

• How can reduced tillage weed management be improved, including development of new tools and 

techniques that provide greater weed control for less soil disturbance? 

Finally, organic farmers use whole-farm planning when deciding what will be done in each of their fields. 

Research that assesses the ecosystem benefits of reducing tillage in patches (field-level) across a farm is 

also needed. For example, the relative benefits of reducing tillage are greater in areas prone to surface 

water runoff. Research is needed to “inform” where reduced tillage practices are likely to have their 

greatest impact. 

4. Managing Cover Crops for On-Farm Fertility - Growing cover crops and green manures is a foundational 

practice on many organic farms. In addition to conserving soil, increasing water holding capacity, and 

providing weed suppression, cover crops supply important plant nutrients and increase soil organic 

matter. As farmers seek to grow their own fertility, more research is needed on the efficacy of relying 

primarily on cover crops to meet production needs, particularly for horticultural crops. At present, 

there is inadequate data on the nutrient benefits of different cover crop mixes and how those benefits 

vary according to species mix, mowing practices, tillage regimes, subsequent planting time of the cash 

crops, and importantly the preceding practices that define the legacy of individual fields. 

5. Disease Management - Disease management in organic fruit and vegetable production relies on a 

systems approach to succeed, but even with current systems plans in place, growers frequently struggle 

to manage commonly occurring blights and citrus greening. The NOSB underscores the need for 

systems research that addresses solutions to these and related diseases that are workable for farmers, 

that reduces adverse health effects on farmers and fieldworkers, and that also limits adverse effects on 

the soil and water in which the crops grow. To this end, we call for systems research that identifies 

disease resistant material while at the same time identifying biological controls that limit the use of 

copper-based compounds where possible. 

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Specifically, targeted research is needed to identify management practices and less toxic alternative 

materials for a wide range of crops. More research is needed on many of the crop/disease 

combinations, including: 

• Comprehensive, systems-based approaches for managing individual crops in a way that decreases 

the need for copper-based materials, including researching crop rotations, sanitation practices, 

plant spacing, and other factors that influence disease. 

• Breeding plants that are resistant to the diseases that copper controls. 

• Developing alternative formulations of materials containing copper so that the amount of 

elemental copper is reduced. 

• Developing biological agents that work on the same diseases that copper is now used on. 

• Evaluating plant nutritional strategies to mitigate the impacts of plant diseases. 

• Particular research on scum and algae control in rice and whether sodium carbonate 

peroxyhydrate or other materials are suitable alternatives in an aquatic environment. 

• Soil management and crop cultivar development for enhanced beneficial crop-root microbe 

partnerships that protect organic crops from soil borne and foliar pathogens. 

• Alternatives to antibiotics (tetracycline and streptomycin) for fire blight control, particularly in 

pears and apples. 

6. Identify Barriers and Develop Protocols for Organic Nursery Stock Production 

The demand for organic nursery stock far exceeds the supply. Research is needed to identify the 

barriers to expanding this market, then develop and assess organic methods for meeting the growing 

demand for organically grown nursery stock. That work could include but is not limited to assessing 

phytosanitary rules for shipping plants and quantifying the production and demand for organic 

rootstock. Research has shown that application of the correct ectomycorrhizal inoculants to roots can 

substantially (50% or more) enhance establishment and early growth of woody perennial horticultural 

crops. How can fine tuning the use of mycorrhizal inoculants to make organic nursery stock production 

easier and more profitable, thereby helping to close the demand/supply gap? Research centered on 

development of practical organic methods for the nursery industry to implement is needed, including: 

• Disease and insect control materials that are allowed under organic standards and may be 

accepted under specific phytosanitary regulatory requirements. 

• New materials for controlling pests addressed by phytosanitary rules that show promise of 

compatibility with National List review criteria. 

• Alternative protocols for phytosanitary certification of nursery stock that are based on outcomes 

(such as testing or inspection) rather than requirements for use of synthetic materials during 

production. 

7. Management and Control of Invasive Insects and Weeds - There is a large pool of research on the 

control of insects and diseases using organic methods. Many controls use a systems approach and are 

quite effective. The introduction of new invasive species into cropping systems threatens these systems 

approaches, and in several cases the organic control options are very limited or nonexistent. For 

example, spotted wing drosophila is a relatively recent invasive insect that infests soft fruits, such as 

berries, and many other fruits as well. Infestation renders fruit unusable since insect larvae feed inside 

the fruit and may reach critical levels before fruit is harvested. This insect is particularly problematic in 

that it has the ability to oviposit in green fruit, and it has multiple generations throughout the summer, 

creating an extensive control period. There is only one control material available, and it is in danger of 

overuse. The control period may also extend so long that maximum label rates are used before the 

season ends. A second invasive insect is brown marmorated stinkbug, and at this time there are no 

organic control measures beyond attempts at mass trapping. Research into organic control options for 

both these invasive pests, and others, is critical so that organic growers can integrate controls into their 

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organic systems. Prevention is critical. Because invasive insect species lack native predators, the 

organic community needs more information on their biology in order to implement prevention 

strategies before they become established and are more difficult to control. 

Weeds pose one of the greatest barriers to successful organic crop production. Invasive weeds include 

exotic species that aggressively displace both crops and native plant species, as well as creeping 

perennial species (exotic or native) that are difficult to control without repeated, intensive tillage. The 

NOP standards require certified organic producers to use tillage and cultivation practices that maintain 

or improve soil conditions. Development of integrated, organic management strategies that effectively 

control invasive weeds without excessive tillage continues to emerge as a top research priority for 

organic producers. 

8. Nutritional Value of Organic Crops - How do organic soil health and fertility practices—crop rotations, 

cover crops, compost and other organic or natural mineral amendments, etc. — affect the nutritional 

value or “nutrient density” of organically produced crops? How do organic production and shipping 

methods (including methods of production, handling, and time in transport) influence the nutritional 

quality, taste, palatability, and ultimately preference for organic vegetables and fruits? There is a lack 

of sound, rigorously conducted studies of this kind. How can growers and handlers retain nutrition 

through post-harvest handling and transportation? Additionally, can providing organic producers 

information on soil biology and soil nutrient composition help improve nutrition? Finally, more studies 

are needed examining how organic crops compare to conventional crops with regards to nutritional 

value. 

9. Side-by-Side Efficacy Comparisons Between National List Allowed and Petitioned Synthetic Inputs 

Versus Non-synthetic Alternative Inputs or Practices 

During its five-year review of sunset materials on the National List and in the evaluation of newly 

petitioned materials, the NOSB often lacks sufficient information of the effectiveness of these materials 

as compared with other synthetics on the National List, natural materials, and cultural methods. Sideby-side trials with approved organic inputs, both synthetic and natural, and cultural methods to 

evaluate efficacy would strengthen the review process and provide growers with valuable information 

in pest and disease management decisions. The NOSB specifically requests collaboration with the Minor 

Crop Pest Management Program Interregional Research Project #4 (IR4) to include materials on the 

National List in their product trials. Such studies would help inform the NOSB review process of sunset 

materials and to determine if materials are sufficiently effective for their intended purpose, particularly 

when weighed against the natural and cultural alternatives. It should be noted that growers commonly 

rely on a mix of cultural practices and both non-synthetic materials and materials from the National List 

to produce crops of marketable quality and sufficient yield for profitability; it is understood that such 

studies would serve as a starting point and would form part of the comprehensive material review 

process. 

10. Evaluation of Microbial Inoculants, Soil Conditioners, and Other Amendments 

Vendors of organic amendments now offer a large and growing array of microbial inoculants, organic 

soil conditioners, and other materials claimed to improve soil health, crop vigor and quality, and 

combat weeds, pests and diseases. There is an urgent need for impartial evaluation of these materials 

to help producers decide which products to use and to avoid unnecessary expenditures on products 

that are unlikely to yield benefits. 

11. Pathogen Prevention - Third-party food safety auditors believe that some biodiversity-maintenance 

strategies employed by organic farmers may increase the risk for introduction of human pathogens on 

the field. While some research has been conducted disproving this hypothesis, more research, 

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extension, and education are needed to fully understand the relationship between on-farm 

biodiversity and food safety – and this research must be communicated to third-party food safety 

auditors and incorporated into their audits. 

12. Climate Change - A growing body of research demonstrates that organic farming can help prevent 

anthropomorphic climate change, and some strategies employed by organic farming can also help with 

resilience to current climate challenges such as drought and flooding. Although a number of 

researchers are examining this issue, additional work is needed to pinpoint specific strategies that 

organic farmers can take to reduce greenhouse gas emissions and respond to current climate 

challenges threatening the future of our food security. 

Handling 

1. Chlorine Materials and Alternatives - 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. 

Chlorine materials are also acutely toxic to workers. New sanitizers and disinfectants are regularly 

petitioned to the NOSB for addition to the National List. FDA regulations on food safety (Food Safety 

Modernization Act) and best management practices for cleaning in handling operations both require a 

suitable level of cleanliness and disinfection to prevent pathogens from entering the food supply. 

Producers and handlers are looking for alternatives to chlorine while continuing to provide a safe 

end product to their customers and the consumer. Addressing food safety while adhering to the 

fundamental organic principles involving human health and environmental impact is a concern. 

The organic industry needs better information on how either alternative materials or appropriate 

chlorine materials are best suited for a specific use and control measure. This is especially important 

in determining if the industry can move away from the use of chlorine compounds in the future. 

Points of consideration for future research activities: 

• Comparison of alternatives to chlorine such as: citric acid, hydrogen peroxide, ethanol, 

isopropanol, peracetic acid, and ozone. How would each compare to the different chlorine 

materials for specific uses? The strengths and weaknesses would need to be considered. 

• Potential human health and environmental impacts of each chlorine material versus the 

possible alternative materials listed above. Are there ways that these impacts can be mitigated 

and still allow the material to work as needed? 

• Determination of which of the above-mentioned alternatives would NOT be a suitable 

substitute for chlorine. What specific uses and/or conditions would this apply to? 

• Identification of practices that could be used to help reduce the formation of trihalomethanes 

in those specific situations where chorine is the best material to use. 

• Could the rotation of materials for cleaning and disinfecting help lower the risks from 

chlorine materials and still be effective in providing the desired control of pathogens? 

• Research on the absorption of chlorine by produce from its use in wash tanks, including 

information about the amount of time of exposure, would help inform understanding of 

human exposure to chlorine and health risks. Are residues from produce washing 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? 

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2. Alternatives to Bisphenol A (BPA) - The Handling subcommittee is examining the issue of whether to 

prohibit BPA in packaging materials used for organic foods in light of direct evidence that these uses 

result in human exposures and mounting evidence that these exposures may be harmful. There is a 

need for increased research about alternatives for the linings of cans and jars used for organic 

products that do not result in human exposures and health risks. 

Materials/GMO 

In previous years, the Materials subcommittee has prioritized the Reduction of Genetically Modified 

Content of Breeding Lines (2013) and Seed Purity from GMOs (2014). These issues are currently being 

addressed through a Genetic Integrity of Seeds Ad Hoc Working Group. 

1. Fate of Genetically Engineered Plant Material in Compost - What happens to transgenic DNA in the 

composting process? Materials such as cornstalks from GMO corn or manure from cows receiving 

rBGH are often composted, yet there is little information on whether the genetically engineered 

material and traits break down in composting process. Do these materials affect the microbial ecology 

of a compost pile? Is there trait expression of Bt (bacillus thuringiensis) after composting that would 

result in persistence in the environment or plant uptake? 

2. Integrity of Breeding Lines and Ways to Mitigate Small Amounts of Unwanted Genetic Material - Are 

public germplasm collections that house at-risk crops threatened by transgenic content? Breeding lines 

may have been created through genetic engineering methods such as doubled haploid technology, or 

they may have had inadvertent presence of GMOs from pollen drift. The extent of this problem needs 

to be understood. 

3. Assess the Genetic Integrity of Organic Crops At Risk - Develop then implement methods of assessing 

the genetic integrity of crops at risk in order to quantify the current state of the organic and 

conventionally produced non-GMO seed. Such assessments are needed on the front (seed purchased 

by farmers) and back end (seed harvested from a farmer’s field) of the production chain as well as on 

points of contamination in the production chain. 

4. Prevention of GMO Crop Contamination: Evaluation of effectiveness - How well are some of the 

prevention strategies proposed by the NOSB working to keep GMOs out of organic crops? For instance, 

how many rows of buffer are needed for corn? How fast does contamination percentage go up or down 

if there are more or fewer buffer rows? Other examples could be whether cleanout of combines and 

hauling vehicles reduces contamination using typical protocols for organic cleaning, whether situating 

at-risk crop fields upwind from GMO crops can reduce contamination, and what the role may be of 

pollinators in spreading GMO pollen. Lastly, research is needed on a mechanism to provide 

conventional growers incentives to take their own prevention measures to prevent pollen drift and its 

impact on organic and identity-preserved crops. This is policy research rather than field research but is 

equally as important. 

5. Testing for Fraud: Developing and implementing new technologies and practices New technologies, 

tests, and methodologies are needed to differentiate organic crop production from conventional 

production to detect and deter fraud. Testing to differentiate conventional and organic livestock 

products, for example omega 3 or other indicators, is also needed. Additional tools to identify 

fraudulent processed and raw organic crops require research to combat this problem. Current 

methodologies include pesticide residue testing, in field soil chemical analysis, and GMO testing. Areas 

in need of further testing methodology include phostoxin residues, fumigant residues, carbon isotope 

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rations for traceability, validating nitrogen sources using nitrogen isotope rations, or other experimental 

testing instruments that can be utilized to distinguish organic raw and/or processed crops from 

conventional items. Additionally, there is a need to develop rapid detection technologies for adaptation 

to field-testing capacities. 

General 

1. Increasing Access to Organic Foods - What factors influence access to organically produced foods? 

Individual-based studies are needed to assess the constraints to accessing to organic food. Research 

should be funded that builds on an understanding of constraints by asking what community, market, 

and policy-based incentives would enhance access to organic foods. 

3. Barriers to Transitioning to Organic Production - What are the specific production barriers and/or 

yield barriers that farmers face during the three-year transition period to organic? Statistical analysis 

of what to expect economically during the transition is needed to help transitioning growers prepare 

and successfully complete the transition process. 

Subcommittee Vote: 

Motion to adopt the proposal on 2020 NOSB Research Priorities 

Motion by: Dave Mortensen 

Seconded by: Emily Oakley 

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

Approved by Dave Mortensen, Materials Subcommittee Chair, to transmit to NOSB August 14, 2020 

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National Organic Standards Board Materials Subcommittee Proposal 

Marine Macroalgae1 in Crop Fertility Inputs 

August 11, 2020 

Summary: 

This proposal brings forward an annotation to marine macroalgae used as crop fertility inputs to provide 

parameters on harvesting addressing conservation areas, bottom trawling, protecting reproduction of 

the population and ecosystem functions, biomass and architecture, and bycatch. 

Introduction and Use: 

Seaweeds are classified into three broad groups based on pigmentation: brown, red, and green; 

respectively, Phaeophyceae, Rhodophyceae and Chlorophyceae (TR 2016 lines 103-4), and all three 

classes are used in organic fertilizers2

. Seaweeds are also called macro-algae, distinguishing them from 

micro-algae (Cyanophyceae) which are microscopic in size and often unicellular (TR 2016 lines 108-110). 

Seaweeds used in synthetic aquatic plant extracts and in nonsynthetic products, namely meal, are 

macroalgae. 

Marine macroalgae are used in extracts as foliar fertilizers or as soil conditioners. They also are used as 

a foliar/soil feed or transplant solution and seed treatment. The material is absorbed into the plant and 

acts as a growth promoter (TR 2006 lines 63-6). Marine macroalgae is widely used by producers. During 

the most recent sunset review of aquatic plant extracts, certifiers reported high numbers of growers 

listing these materials on their Organic System Plans. 

Background: 

In 2015, the board had a lengthy sunset review, and as part of that process reviewed marine materials in 

the Handling (seaweeds for human consumption), Crops (aquatic plant extracts for fertilizers), and 

Livestock (kelp for feed) subcommittees. In the Crops Subcommittee, the majority of initial comments 

were in favor of keeping aquatic plant extracts on the National List. During the fall public comment 

period, the Subcommittee identified concern about potential overharvesting. Extensive public comment 

was received on this issue. At the end of the fall 2015 meeting, the board recommended keeping 

aquatic plant extracts on the National List; however, the vote was divided. The board consequently 

prioritized review of this topic and determined that a Technical Evaluation Report (TR) was needed on all 

the marine plants used in organic production across the Crops, Livestock, and Handling Subcommittees. 

The board received the limited scope TR on Marine Plants and Algae in summer 2016. Subsequently, 

the Handling Subcommittee published a fall 2016 Discussion Document for Marine Algae Listings on the 

National List. In it, the board stated that “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”. The board solicited public comment on 

addressing naming conventions as well as developing guidelines for wild harvested seaweeds. As a 

result, a spring 2017 Proposal on Marine Algae Listings was posted in the Crops Subcommittee, which 

was virtually identical to a similar proposal in Handling, and it tried to address classification and 

nomenclature. In the Crops section, a proposal was put forth to limit aquatic plant extracts to those 

1 For the purposes of this proposal, the term “marine macroalgae” is used to refer to marine plants, seaweed, and 

marine vegetation. 

2 The 2016 TR lists species used in fertilizers and their harvest regions. This list can also be found in on page 3 of 

the fall 2018 Discussion Document on this topic. 

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derived from brown macroalgae. Public comment revealed there were numerous products containing 

red, green, and brown macroalgae. In Handling, significant public comment was received stating 

stakeholders needed more time to address the classification and nomenclature issues. The Handling 

Subcommittee re-posted the Discussion Document for the Fall 2017 but received no significant 

additional public comment. 

The work agenda item was moved to the Materials Subcommittee, and the board explored new 

approaches to addressing concerns about environmental impact. The Materials Subcommittee posted a 

fall 2018 Discussion Document proposing that all marine macroalgal ingredients used in organic crop 

production be certified organic. The spring and fall 2019 Discussion Document solicited comments on 

the question of organic certification or an annotation specifying harvest methods. To further explore 

this complex topic, the board convened an expert Panel on Marine Materials used in crop inputs at the 

fall 2019 meeting. 

The goal of the board’s work on this topic is to take a precautionary approach to ensuring that both 

synthetic and nonsynthetic forms of marine macroalgae used in fertilizers are not “harmful to ... the 

environment” by adversely impacting the ecosystem provisioning of the marine environment. 

Relevant Areas of the Rule, NOP Guidance, NOP Policy Memo, and NOSB Policy and Procedures 

Manual: 

OFPA Section 6517 [National List] (c) [Guidelines for Exemptions or Prohibitions] (1)(a)(i) and (2)(a)(i) 

which allows for the prohibition of synthetic or nonsynthetic substances, respectively, that would be 

“harmful to ... the environment.” 

§205.2 Terms defined. 

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. 

§205.601 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 does 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. 

§205.207 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. 

§205.200 General. 

Production practices ... must maintain or improve the natural resources of the operation, including soil 

and water quality. 

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7 U.S.C. 6518 National Organic Standards Board, 6518 (b) Board composition, (4) 

three shall be individuals with expertise in areas of environmental protection and resource 

conservation; (6) one shall be an individual with expertise in the fields of toxicology, ecology, or 

biochemistry. 

NOP 5022, effective July 22, 2011, Guidance: Wild Crop Harvesting provides details to clarify §205.207, 

including: 

Section 205.200 states that production practices must maintain or improve the natural resources of an 

operation under organic certification. This applies to all types of organic certification, including wild 

crops. 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. 

Additionally, the Guidance states: 

1. A description of the proposed ecosystem management and harvesting practices, the impact of 

their proposed harvesting on the long-term viability of the wild species and on the area’s 

ecosystem, and information on any equipment planned for use or being used to harvest and 

manage the wild-crop and ecosystem. 

a. This should include a description of the monitoring system that will be used to ensure 

that the crop is harvested in a sustainable manner that does not damage the 

environment, including soil and water quality. 

2. A list of any rare, threatened, or endangered terrestrial or aquatic plants or animals that occur in 

the harvest area. 

a. The presence of rare, threatened, or endangered species in a wild harvest area does not 

automatically disqualify an operation from organic certification, but any potential or 

actual impacts need to be described and addressed. 

b. If there are potential or actual negative impacts resulting from the wild crop 

management and harvesting, actions that address and correct these impacts need to be 

described, implemented, and monitored. 

3. The procedures employed that prevent contamination from adjoining land use or other point or 

non-point sources contamination. 

4. The training provided and the procedures employed to ensure that all collectors harvest crops 

in accordance with the OSP and in a manner that does not damage the environment. 

NOP 5020, effective 1/15/16, Guidance: Natural Resources and Biodiversity Conservation clarifies 

organic regulations at 7 CFR 205.200 that states, “to maintain or improve the natural resources of the 

operation....”. 

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 

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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. 

NOSB Policy and Procedures Manual, Principles of Organic Agriculture Organic agriculture, adopted 

2001, 1.1 states: Organic agriculture...is an ecological production management system that promotes 

and enhances biodiversity, biological cycles, and soil biological activity. 

Public Comments: 

Public comments over the past several years have been diverse on this topic and range from support for 

organic certification as an appropriate tool to address environmental impacts of harvesting, to caution 

against setting a precedent of certifying an input ingredient, to concerns that certification could amount 

to greenwashing by inadequately addressing environmental impact, to sentiments that the industry 

does not need further regulation. A broad review of public comments can be found in the earlier 

discussion documents referenced above. 

The 2019 spring and fall discussion document asked stakeholders to provide feedback on the possibility 

of requiring organic certification for marine macroalgae input ingredients, presented standards from 

other certifiers and third-party entities certifying sustainable seaweed, solicited numbers of crop input 

products approved for use that currently contain certified organic marine algae ingredients, and 

inquired if farmed algae is used in any products. Public comments covered all questioned posed. 

Although several certifiers were skeptical about the ability to certify wild aquatic systems, it was also 

noted that this is already being done for handling and livestock uses of marine macroalgae. Importantly, 

material review organizations reported that there are some crop fertilizer products now that formulate 

with certified organic marine macroalgal ingredients. Farmed algae do not appear to be used, likely 

given the high cost of seaweed aquaculture compared with the large volumes of material needed for 

fertilizers3

. 

While some worried about increased scrutiny of additional nonsynthetic inputs, others said some 

natural inputs likely deserve more scrutiny for their environmental impact. Opposition to requiring 

organic certification was centered on precedent setting and the inconsistency of requiring certification 

for one type of input but not others (though there were also some who felt marine macroalgae should 

not be certified organic as its harvest can never meet the standard of not destructive to the 

3 Theuerkauf et al. discuss the potential of seaweed aquaculture to mitigate seagrass beds and kelp forests losses 

globally as a result of overharvesting and other human activities (2019). See Buschmann et al. on the prospects of 

seaweed cultivation to alleviate increasing harvest pressure, particularly of Macrocystis pyrifera (2014). 

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environment). One commenter supporting certification as a tool stated that if organic certification is 

important for food, the organic community should also see it as viable for inputs. They noted, “we do 

not believe that requiring organic certification of marine material inputs would create the universal 

expectation that all crop inputs, such as manure and mulches, be certified organic”. Another 

commenter shared that “sourcing of inputs, including those from natural resources, can have significant 

impact on the sustainability of agricultural systems, and NOSB is responsible for making 

recommendations for inputs on the National List that would not harm the environment”. 

Some public comment supported using annotations to the National List and definitions as the best 

means for developing clear standards rather than requiring certification. NOP guidance would provide 

additional information on implementation, as well as training areas for inspectors. It was felt that an 

annotation could specify parameters for harvesting and would be more enforceable than attempting to 

establish such parameters through guidance complementing an organic certification requirement. A 

material review organization said they could hire staff capable of reviewing an annotation and 

conducting on-site inspections. 

One public commenter and marine biologist proposed “some key aspects to be considered within the 

definition of ‘not destructive to the environment’: a) the amount that can be harvested from an area; b) 

the method and timing of harvest; c) the impact of the harvest on the structure and reproduction of the 

plants themselves; d) the consequences of the changes in the canopy for other species; e) the direct 

removal of non-target species (by-catch); and the ability of the ecosystem to f) remain resilient in the 

face of many challenges (climate change, invasive species) and g) maintain essential functions and 

services”. Another marine scientist emphasized the need to focus on the habitat marine macroalgae 

provide when considering the effects of harvesting. 

Some stakeholders suggested prohibiting specific species, regions, or harvest methods might be an 

option. Some felt government regulations are adequate, though it was acknowledged that they do not 

typically involve on-site verification and enforcement varies. One stakeholder suggested that more 

information is needed about existing legal frameworks in countries where most marine macroalgae used 

in fertilizers is harvested. 

The board particularly requested industry participation and heard from a number of harvesters in the 

fall 2019 public comments. Several harvesters stated that the harvest of rockweed, for example, is well 

regulated and does not negatively impact the marine environment. One harvester explained that they 

follow biomass assessments, closed areas, minimum cutting heights, and periodic auditing. They 

indicated that if the wild crop standards for organic certification as applied to marine macroalgae feed 

for livestock remained the same for certification of macroalgae for fertilizer products, they would 

support organic certification. Another harvester said that while not against organic certification, they 

prefer applying the commercial availability clause instead. One harvester and processor stated that 

annual regrowth of the seaweed extracted exceeds the amount harvested. A company based in Ireland 

explained its compliance process with each of its harvesters, which includes hand harvesting to preserve 

“the balance of the ecosystem without damaging environmental issues that could arise from this 

activity”. 

An industry task force was developed by one association to foster discussion around this topic. There 

was a request for more documentation of the need for monitoring harvests to avoid environmental 

impact. In addition, the stakeholder said that more information on global harvesting rates is needed. As 

noted by the Food and Agriculture Organization, “About 25 million tonnes of seaweeds and other algae 

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are harvested annually for use as food, in cosmetics and fertilizers, and are processed to extract 

thickening agents or used as an additive to animal feed.” Unfortunately, accurate global harvest rates 

for marine macroalgae across all uses is difficult to obtain. Equally, information on the impact of 

harvests for fertilizers is unavailable on a global level (see the review of the scientific literature below for 

more information). 

One public commenter provided a comprehensive overview of all marine materials used in organic 

production across macroalgal and fish uses in Crops, Livestock, and Handling. Although some public 

comment suggested we look at all marine uses across all subcommittees under one work agenda item, 

there are practical limitations that make that challenging. Significant differences exist between fish and 

marine macroalgae and between Handling and Livestock uses. Each marine material on the National List 

represents a discreet use that warrants individual attention. If the work agenda item were too large, it 

might preclude meaningful progress. 

Stakeholders asked the board to create standards that cover existing certified organic marine macroalgal 

materials. Some were concerned that the board not create a higher standard for crop fertility uses of 

marine macroalgae than for human consumption and livestock feed. Alternatively, it could be argued 

that most seaweeds used in organic handling and all used in organic animal agriculture receive some 

measure of oversight and protection through their certification to the wild crop standard. The 

inconsistency lies in using the same, unverified input in fertilizers that is certified organic in handling and 

livestock uses. Additionally, the wild crop standard is necessarily general to cover the wide range of 

crops it can include. But in its generality, it does not give guidelines for how the standard operates in 

complex marine environments. As one commenter said, the existing wild crop standards “are very 

limited” and “do not provide sufficient metrics for certifiers”. Given the complexity of this topic, this 

proposal is intended as a first step, with subsequent explorations of marine macroalgae uses in Handling 

and Livestock. Annotations for Handling and Livestock uses will be the next area the Materials 

Subcommittee investigates. 

In conclusion, one harvester of certified organic kelp meal noted “agriculture by its very nature causes 

environmental harm, even organic agriculture disrupts the natural succession of the ecosystem”. 

Organic agriculture is founded on practices intended to minimize its environmental impact and harm. 

The commitment organic farmers demonstrate to soil and water conservation, fostering biodiversity, 

and limiting negative impacts of synthetic chemicals through a host of practices relates to a desire by 

many to source inputs reflecting similar values. 

Discussion: 

Review of the Literature 

A review of the literature on the environmental impact of commercial seaweed harvesting varies in its 

findings. The 2016 TR raised concerns about the potential for negative environmental impacts on 

marine ecosystems from macroalgal harvesting. Some examples noted in the 2016 TR were specific to 

species used in organic crop fertility inputs and aquatic plant extracts. For example, in mechanical 

harvesting in Iceland, as with other areas where Ascophyllum nodosum and Laminaria digitata are 

harvested commercially, ecological concerns about changes in species diversity resulting from 

harvesting have been noted (TR 2016 lines 892-6). The cited paper states “industrial harvesting of the 

seaweed Ascophyllum nodosum in the Bay of Breioafjorour inevitably leads to the death of huge 

numbers of invertebrates, including species that are important food for birds” (Ingolfsson 2010). In 

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Nova Scotia, commercial yields of rockweed are maintained. A comprehensive assessment of impacts 

performed by industry or third-party research proving harvest rates are not detrimental to the rockweed 

marine community is lacking. Estimated recovery times based on percentages of rockweed removed 

vary between publications (TR 2016 lines 597-600). Additionally: 

There is one species of red algae and two species of brown algae growing along the 

coasts of the United States that have gained attention as ecologically threatened in 

recent years. They are respectively, Irish moss (Chondrus crispus), rockweed 

(Ascophyllum nodosum) and giant kelp (Macrocystis pyrifera). These plants are 

economically important and drive several seaweed industries including cosmetic 

products, nutraceuticals, fertilizers and hydrocolloids. Fertilizer applications are similar 

to farmyard manure, but may also include extracts and foliar applications (Chojnacka, 

2012). 

Kelp and rockweed, are foundational species forming large expansive marine habitats 

supporting a diverse range of wildlife, including other algal species, marine animals and 

many species of protozoans and bacteria (Seeley and Schlesinger, 2012). Without a good 

accounting of all of the species present it is hard to predict the effects of harvesting 

rockweed and kelp on each ecological niche. Thus, it has been important to recognize 

that sustainable seaweed production perceived as reproducible harvest capacity, may 

not guarantee the sustained subsistence of each resident species. Although not part of 

any agricultural waste stream, extracts from wild-harvested kelp and rockweed are 

allowed for use in organic production as soil amendments (§205.601(j)(1)). [TR 2016 

lines 522-535]. 

Even within the 2016 TR, differences of opinion about the environmental impacts of harvesting were 

noted within the scientific community. For example: 

One study addressing the major components of the resident fish community in the rocky 

intertidal zone after rockweed harvest found no evidence linking rockweed harvest to 

changes in the ichthyoplankton component or the juvenile and adult fish of that 

community (van Guelpen and Pohle, 2014). In a summarized review of selected work, a 

researcher at the University of Maine also concluded that the effect of 17% rockweed 

harvest on some species including seabirds was negligible (Beal, 2015). [TR lines 326-31] 

The TR goes on to explain that: 

Notwithstanding, rockweed has an important role as habitat, as food and as a nutrient 

source supporting a community of organisms that inhabit its “forests.” Any cutting of 

rockweed can produce an effect on the supported eco-communities. Furthermore, 

many aspects of this ecosystem have not been elucidated, encouraging more precaution 

as the brown algae “forestry” industry grows into the future (Seeley and Schlesinger, 

2012). [TR lines 356-60] 

Since 2016, the board has received numerous public comments by marine macroalgae experts and other 

stakeholders, and these have included myriad references to the academic literature. A reading of the 

comments and their citations reveals the many views on the environmental impacts of harvesting 

marine macroalgae. Nevertheless, it cannot be said that removing a wild native species from a wild 

native ecosystem, as in the case of commercial marine macroalgal harvests, has no impact on the 

environment. As explained above, the extent to which harvesting causes negative environmental 

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impacts is contested within the literature4. There are certainly papers that will state views counter to 

those cited below, and interestingly, the same papers are quoted to support competing claims5

. It is not 

the goal of this proposal to argue over whose science is right. 

The literature review on the environmental impacts of harvesting is not intended to suggest that effects 

cannot be at least partially mitigated or that harvesting should not occur. Rather, the information was 

requested in public comments, and it is presented to demonstrate the complexity of the issue and to 

address claims made in some public comments that harvesting has little effect on the environment. 

While it is not possible to provide a comprehensive analysis of peer-reviewed research here and there 

are numerous other articles that could have been cited, the following review of the scientific literature 

provides the technical data to support this proposal. 

“Canopy-forming seaweeds, including kelps, rockweeds and many red seaweeds are widely 

acknowledged as foundation species that form important three-dimensional structure in marine coastal 

environments which contribute important functions and services” (Lotze et al. 2019). These include 

primary and secondary production, production of detritus, nutrient cycling, carbon storage, nutrient 

retention, provision of food for biodiversity, biological links between marine ecosystems, habitat for 

year-round residents, foraging grounds, breeding and nursery areas, refugia from predators, coastal 

buffers from waves and storms, and filters for runoff (Ibid). “Despite the ecological importance of 

seaweed canopies and their long history of harvesting, relatively few studies have directly examined the 

effects of harvesting beyond the resource species itself on ecosystem structure, functions and services” 

(Ibid). The authors conclude that: 

harvesting canopy-forming seaweeds affects the morphology, canopy structure, standing stock 

and species composition of the foundation species which in turn affects their ecological roles in 

marine ecosystems (Table 2). The magnitude and range of ecosystem impacts depend on the 

species being harvested, the harvest methods employed, the intensity of biomass removal and 

its spatial and temporal extent (Supplementary Text S2 and Table S2.1). The broader ecosystem 

effects further depend on the recovery of seaweed fronds and regeneration of seaweed 

canopies after harvesting, and the ability of associated flora and fauna to recolonize and 

reorganize associated communities. (Ibid) 

Schmidt et al.’s (2011) study of ecosystem services of eelgrass and rockweed found that: 

marine vegetation provides important habitat, nitrogen, and carbon storage services, yet the 

extent of these services depends on the foundation species and its architecture. Changes in 

canopy structure will therefore have profound effects on associated food webs and ecosystem 

services. Thus, as increasing human pressures on coastal ecosystems threaten the continued 

supply of essential functions and services, the protection of marine vegetated habitats should be 

a management priority. 

Mac Monagail et al. (2017) offer a comprehensive analysis of the environmental impacts of marine 

macroalgal harvesting, including the effects of over-exploitation on biomass and coastal habitats. They 

state, “as is the case with the use of all natural resources, the wild harvest of seaweeds inevitably has 

ecological implications for the species targeted, and the associated 

4 For example, Phillippi et al.’s (2014) study indicates potential beneficial impacts of Ascophyllum nodosum 

harvesting on invasive crabs. The paper acknowledges that “human utilization of any natural resource involves 

ecological implications not only for the species harvested, but for its associated community as well” (Ibid). 

5 See for example Sharp and Pringle 1990, Sharp et al. 2006, Ugarte 2010, and Ugarte and Sharp 2001, among 

others. 

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community of flora and fauna, leading to varying degrees of change” (Ibid). Additionally, “Poorly 

managing resources, such as opportunistic harvesting, excessive removal of holdfast material (reducing 

regeneration), trampling and enhanced grazing by herbivores all place additional stresses on the 

resource, while near denudation of a seaweed bed is perhaps the most extreme case of direct impact on 

the community (Ibid)”. The authors point out that sustainable harvesting practices are possible and 

collaborations between scientists and harvesters have led to the development of best practices in some 

places. 

The impacts of hand versus mechanical harvesting are contested, but mechanization increases the 

amount of biomass removal in the same amount of time. In Ireland, review of potential mechanization 

cautioned that it is “essential to develop a suitable management scheme to ensure sustainable 

exploitation of natural resources and continuous integrity of marine habitats” (Werner and Kraan 2004). 

In a separate study in Ireland, even traditional hand harvesting resulted in a difference in cover of 

associated algal species following the removal of the target species (Kelly et al. 2001). Additionally, 

there were seasonal differences in “the abundance of periwinkle Littorina obtusata in hand harvesting 

(Ibid). Krumhansl et al. (2017) found that small-scale, “artisanal” harvesting of Macrocystis pyrifera in 

the Pacific Northwest had a minimal impact on kelp recovery rates. Lotze et al. (2019) note: 

Any harvesting method will affect the extent and three-dimensional structure of a seaweed 

canopy, but the magnitude and range of consequences will depend on the gear type, the 

harvest intensity and scale, and the cutting methods applied. While mechanical clear-cutting or 

trawling will remove most of the canopy with years to decades needed for recovery, even lower 

level hand-harvesting changes canopy structure through a truncation of larger, older and more 

voluminous fronds... Cutting height plays a crucial role in frond regrowth, such as for perennial 

rockweed, and repeated cutting can change the branching, size, and density of seaweed fronds. 

Such changes in the amount and structure of the seaweed canopy will affect the quantity and 

quality of habitat provision and community organization”. 

Calculations of the ecological effects of kelp trawling in Norway 

show that kelp trawling reduces primary and secondary production substantially within the kelp 

trawled tracks. Primary production is reduced with 45 % and secondary production with 70 to 98 

%... Observations indicate that diversity of flora and fauna will be reduced within the trawled 

area. The diversity will probably not recover until the mean age of the plants reach the mean 

age of the large kelp plants in untrawled kelp forest. Mean age increases with increasing latitude 

and is about 7 years in mid-Norway, where the kelp forest has optimal growth conditions and is 

well developed. With a trawling interval of 5 years, the kelp forest within mid-Norway will not 

be recovered with respect to species diversity until next trawling. (Rinde et al. 2006) 

In a study of biomass and productivity of intertidal rockweed, Vadas et al. (2004) found significant 

variation in the length of apical tip growth, estimates of standing crop weight, and annual productivity 

estimates. Another study measuring the effects of fucoid bioengineer species on the understory along 

intertidal elevation gradients in Atlantic Canada found “a combined experimental and mensurative 

approach shows that the same bioengineer species affect overall species richness, diversity, and 

composition differently along a stress gradient” (Watt and Scrosati 2013). Specifically, they discovered 

that “bioengineer canopies have different effects on understory communities depending on intertidal 

elevation”, and this is significant to conservation efforts since “the loss of bioengineers is a concern 

because these organisms often have wide-ranging and cascading effects” (Ibid). Therefore, “biologists 

need to consider not only whether bioengineers are present, but also the abundance required to elicit 

positive changes in communities” (Ibid). 

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One review of the ecological impact of harvesting in the northwest Atlantic concluded that “long-term 

harvesting has altered the population structure and population ecology of C. crispus and A. nodosum in 

some areas” but went on to state that “both target species and associated communities are resistant to 

perturbation” (Sharp and Pringle 1990). Foster and Barilotti (1990) emphasize “the need for considering 

the potential effects of seaweed harvesting at both the population and community level, and the utility 

of approaching these effects in a comprehensive manner”. They explain that considering the harvest 

type, procedures, and ecological effects on the target population, community, and ecosystem are 

essential for maintaining harvestable marine macroalgal resources. In an experimental study of the 

ecological effects of harvesting kelp in Chile (in this case for alginates), the researchers concluded there 

were significant impacts on both the harvested and related species: 

Experimental studies of Lessonia nigrescens and L. trabeculata have revealed several ecological 

effects of harvesting that ought to be considered when managing wild stocks of these species. In 

both kelps, the removal of the upper canopy eventually leads to death of the plants. The 

invertebrate fauna does not abandon the holdfast of pruned L. nigrescens. Therefore, both 

partial and complete plant removal has similar mortality 

consequences for the kelp and for the invertebrate fauna associated with the kelp. 

The most important population effects of removal are the increments in inter-plant distances 

and the resulting increasing access of grazers to the kelp holdfast and to inter-holdfast surfaces. 

Increased grazing reduces recruitment of both Lessonia species and modifies the morphology of 

L. trabeculata, rendering individuals of the latter species more susceptible to being removed by 

water movement. (Vasquez and Santelices 1990) 

In a review of global kelp forests, Wernberg et al. (2019) state that “kelp species show global declines 

and, like so many other marine ecosystems, they are under pressure from direct and indirect 

anthropogenic activities”. These include climate change (warming waters, acidification, and increased 

storm activity), fishing (when urchin predators decline due to fishing, urchins increase grazing on kelp), 

and direct harvesting of kelp. However, when species-specific biology is understood and respected, 

sustainable harvests are possible (Ibid). In another global review of kelp forest change, Krumhansl et al. 

(2016) note that “kelp harvesting accounted for recent kelp declines in Central and Northern Chile 

despite a regional cooling trend”. 

Sharp et al. (2006) explain that “harvesting can affect the structure of these marine plant habitats by 

changing branching structure, canopy height, distribution of biomass and overall density of plants and 

fronds”. Vasquez (1995) states that “if the disturbance (e.g. harvest) is strong enough, changes occur in 

the abundance of harvested and/or associated species, and in availability of some resources (e.g. space 

and light)”. 

Boaden and String’s (1980) study abstract in Northern Ireland provides a quantitative overview of 

ecosystem effects of harvesting Ascophyllum nodosum, though it must be noted that the study cut 

rockweed “within 10-15 cm of the base, rather shorter than normal harvesting practice”: 

In 1976 an attempt to establish harvesting in Strangford Lough, Northern Ireland, was opposed 

on mainly theoretical conservation grounds. The attempt began and stopped within a single 

small bay leaving a sharp boundary between cut and uncut areas. A subjective survey apparently 

confirmed the predicted loss of cryptic fauna, decline through predation and the resorting of 

interboulder sediment. In April 1979 the cut and uncut areas were examined in detail to 

determine whether any of these effects had persisted and were demonstrable scientifically. 

Beach and boulder transects and various other studies showed some increases in the cut area. 

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There was significantly more Fucus, Enteromorpha and Ulva; Cirratulus (inhabiting 

Rhodochorton-bound sediment on boulder surfaces) had a greater biomass. Some changes in 

Littorina colour morphs were apparent. Sediment in the cut area was coarser and had 

significantly more crustacean meiofauna. Ascophyllum internodal length and lateral branching 

were increased but it still provided 20 % less shore cover than in the uncut area. There were 

significant decreases in the cover of Cladophora on the sides of boulders and of Halichondria, 

Hymeniacodon and Balanus on undersurfaces. Indeed on the habitable underside of boulders 

total animal cover had been reduced by nearly two-thirds and the average number of species 

per boulder by one-third. It is concluded that Ascophyllum harvesting has a significant and 

persistent effect on shore ecology. Littoral algae are a valuable commercial asset, but it is 

important that some fairly large intertidal areas should be left unharvested for general 

conservation purposes. 

Defining overharvesting is potentially subjective, yet the consequences are not. “Over-harvesting can 

lead to a reduced density of seaweed thalli, skewing the population mix and increasing impurities (i.e. 

other, unwanted seaweed species) in the harvested seaweed loads” (Mac Monagail et al. 2017). “In 

Atlantic Canada, a shift from Irish moss to coralline algae has been observed multiple times over past 

decades due to overharvesting and did not easily or rapidly reverse” (Lotze et al. 2019). Some 

stakeholders have noted a “tragedy of the commons” associated with harvest areas. In Chile, research 

on the effects of fishing pressure found that Territorial User Rights for Fisheries “areas could be 

important ancillary conservation instruments in kelp forest ecosystems, if key processes of the subtidal 

community assemblages (e.g., interactions between grazers and reef fish) are maintained” (Pérez-Matus 

2017). 

An example of differing views on the harvesting Ascophyllum nodosum causing a deficit of detritus and 

the response reiterating the finding can be found in Garbary et al. (2017). The authors affirm that 

harvesting creates a “‘missing’ biomass ... primarily in the form of detritus never produced because of 

the nature and timing of the harvest” and state their original paper underestimated the deficit (Ibid). 

Ugarte and Sharp (2012) assert that the consistent yields of Ascophyllum nodosum is “is proof of good 

management practices and an ecologically sustainable harvest in the Canadian Maritimes”. However, 

Halat et al. (2015)state that while previous research demonstrates the regeneration of Ascophyllum 

nodosum, it “does not address wider ecological issues associated with overall environmental impact”. 

Detrital deficits in Ascophyllum nodosum could be of concern due to “the role of the 'missing' detritus 

that should be serving coastal fertility in the form of dissolved and particulate nutrients for both 

planktonic and benthic organisms from primary producers through to detritivores” (Ibid). “This detritus 

is typically released through epidermal shedding, and if not consumed by herbivores or microbes before 

reaching the upper intertidal zone, it contributes to coastal, terrestrial 

fertility” (Mac Monagail et al. 2017). For kelp, Krumhansl and Scheibling (2012) found that: 

Detritus settles within kelp beds or forests and is exported to neighboring or distant habitats, 

including sandy beaches, rocky intertidal shores, rocky and sedimentary subtidal areas, and the 

deep sea. Exported kelp detritus can provide a significant resource subsidy and enhance 

secondary production in these communities ranging from tens of meters to hundreds of 

kilometers from the source of production. Loss of kelp biomass is occurring worldwide through 

the combined effects of climate change, pollution, fishing, and harvesting of kelp, which can 

depress rates of detrital production and subsidy to adjacent communities, with large-scale 

consequences for productivity. 

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A study measuring the biomass removal of Ascophyllum nodosum found that natural storm occurrences 

removed a significantly higher percentage of holdfast material than commercial harvestings (Ugarte 

2010); however, this point (one made frequently in public comments) must bear in mind that storms are 

a natural part of the ecosystem whereas harvesting and removal of the species from the ecosystem is 

not. As the same paper notes, “environmental concerns will continue influencing marine resource 

management in Canada, especially when the harvested resource is also a habitat” (Ibid). Any amount of 

harvesting will have some ecological impacts, and in Nova Scotia “because Rockweed harvesting disturbs 

habitat through alteration of the canopy structure and has high levels of bycatch, unharvested 

Rockweed beds, which are likely more common on the Eastern Shore, have a substantially higher habitat 

value than those that are harvested” (Jeffery et al. 2020). 

In a three-year study in Norway, the multitrophic effects of kelp harvesting were investigated by 

Lorensten et al. (2010): 

Coastal kelp forest ecosystems provide important habitats for a diverse assemblage of 

invertebrates, fish and marine top-predators such as seabirds and sea mammals. Although kelp 

is harvested industrially on a worldwide scale little is known about the multi-trophic 

consequences of this habitat removal. We investigated how kelp fisheries, which remove 

feeding and nursery grounds of coastal fish, influence local food webs and the availability of 

food to a marine top predator, the great cormorant (Phalacrocorax carbo). We conducted 

experimental harvesting of the canopy-forming kelp (Laminaria hyperborea) during a 3 year 

period (2001–2003) in an area at the coast of Central Norway while synoptically monitoring fish 

occurrence and cormorant foraging parameters. Our results demonstrate that cormorants 

preferentially foraged within kelp-forested areas and performed significantly more dives when 

feeding in harvested versus un-harvested areas suggesting lower foraging yield in the former 

case. In kelp areas that were newly harvested the number of small (<15 cm) gadid fish was 92% 

lower than in un-harvested areas. This effect was persistent for at least 1 year following harvest. 

To our knowledge, this is the first time that the ecological consequences of kelp harvesting have 

been tested at a multi-trophic level. The results presented strongly suggest that kelp harvesting 

affects fish abundance and diminishes coastal seabird foraging efficiency. Kelp fisheries are 

currently managed in order to maximize the net harvest of kelp biomass, and the underlying 

effects on the ecosystems are partly ignored. This study calls for re-assessment of such 

management practices. 

In a twenty-year study of Ascophyllum nodosum in Iceland, Ingólfsson and Hawkins (2008) concluded 

that full canopy recovery after harvest took seven to eight years, but community recovery could take as 

much as twenty years. When Ascophyllum nodosum was removed but understory algae species were 

left undisturbed, some of those species died and did not return to the study sites (Ibid). In the 

southwest English Channel, Migne et al. (2014) found that while “the number of species [and] their 

distribution among trophic groups” was unaffected by canopy removal of Fucus serratus “and the algal 

community was only slightly affected”, the “abundance and biomass of mobile invertebrates ... were 

greatly reduced in the absence of canopy”. 

The importance of harvesting method is underscored in Waage-Nielsen et al. (2003) whose study 

showed that leaving kelp holdfasts was significant to associated kelp fauna. “The remaining holdfasts 

were the best refugia or alternative habitat in this study, as they contained a fauna very similar in 

composition to the fauna associated with the natural kelp plants” (Ibid). Alternative harvesting methods 

for Ecklonia maxima in South Africa, in which only the fronds were cut rather than the whole plant, 

“shows considerable promise in that the required commercial yield can be achieved from much smaller 

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areas than if whole plants are harvested” as plants remain living and recover more quickly (Levitt et al. 

2002). Nevertheless, “the possible effects of disturbance on the benthos, together with the short 

lifespan of suspended kelp zoospores ..., may negatively affect Ecklonia recruitment, particularly if it is 

strongly episodic” (Ibid). In their study of the effects of commercial harvesting of Fucus 

serratus, Palmaria palmata, and Porphyra on ecosystem biodiversity and functioning, Stagnol et al. 

(2016) found that the hand harvesting methods employed had the greatest impact “on the diversity of 

the animal community and the metabolism of the studied area”, largely due to the opportunistic 

settlement of Ulva spp. (2013). Steen at al. examined kelp regrowth after harvesting in Norway and 

found that the target species “had regained its dominance at the harvested sites, however, plant age, 

sizes and epiphytes were still below pre-harvesting levels”. While Laminaria hyperborean biomass 

recovered after four years, this was due to high density of the recovering kelp vegetation; “the density 

of understory kelp recruits 4 years after harvesting was significantly lower than it had been prior to 

harvesting, and this may lead to a slower recovery if future harvests occur before the stocks of 

understory kelp recruits are restored” (Ibid). In their research of the impact of harvesting on canopyforming macroalgae, Stagnol et al. (2016) 

found that patterns of recovery following the harvesting disturbance were variable and matrix 

specific, suggesting that local factors and surrounding habitat characteristics mediated the 

influence of harvesting. The greatest and longest effects of harvesting were observed for the 

targeted species that created a dominant and monospecific canopy on their site prior to the 

disturbance. Another relevant finding was the important natural spatiotemporal variability of 

macrobenthic assemblages associated with canopy-forming species, which raises concern about 

the ability to discriminate the natural variability from the disturbance impact. 

Although certain countries have developed marine macroalgae management plans and regulations, 

others have not (Rebours et al. 2014). As harvesting: 

increases, there is also an urgent need to develop and implement ecosystem-based 

management models and integrated coastal zone planning. Policy makers must develop 

regulations and directives that enable a sustainable exploitation of the natural resource, not 

only to preserve marine and coastal ecosystems but also to ensure social stability and economic 

income of local communities (Ibid). 

Lotze et al. (2019) “outline potential ecosystem-based management approaches that would help sustain 

productive and diverse seaweed-based ecosystems” for harvesting. They specify areas reflected below 

in this proposal, including “maintaining high canopy biomass, recovery potential, habitat structure and 

connectivity, limiting bycatch and discards, while incorporating seasonal closures and harvest-exclusion 

zones into spatial management plans” (Ibid). Stagnol et al. (2016) note their “results support the need 

to implement ecosystem-based management, assessing both the habitat conditions and ecological roles 

of targeted commercial species, in order to insure the sustainability of the resource”. In the case of 

Ascophyllum nodosum, Seeley and Schlesinger (2012) state “besides setting the removal rate at the right 

level, other critical parameters that need to be considered in defining an ecologically sustainable harvest 

include recovery of preharvest rockweed morphology, rockweed bed structure, rockweed community 

structure and function, and ecosystem function”. Similarly, in another study of Ascophyllum nodosum, 

Kay et al. (2015) found that “plant and canopy structure, including length, circumference and density, 

were much better predictors of associated community structure than rockweed biomass, which is often 

used for single-species monitoring”. 

The precautionary approach is not new to marine macroalgae harvesting and was used to development 

a management strategy for in Atlantic Canada following public concern over negative impacts of 

exploitation of marine resources and in recognition of its habitat function for invertebrate and 

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vertebrates (Ugarte and Sharp 2001). Similarly, “the European Union has defined an organic label for 

macroalgae, which implies that the commercial harvest of algae shall not cause a significant impact on 

ecosystems” (Stagnol et al. 2013). In the absence of adequate baseline measures of existing macroalgal 

stands, “robust and precautionary management measures should be adopted” (Lotze et al. 2019). 

Regulatory Oversight 

“The current wild seaweed harvesting methods, regulations and management regimes vary widely 

across species and countries” (Lotze et al. 2019). Government regulatory agencies acknowledge the 

environmental impact of seaweed harvesting through various restrictions. For example, in Nova Scotia, 

the Rock Weed Harvesting Regulations of the Fisheries and Coastal Resources Act describe permitted 

harvest areas, allowable harvesting methods and quotas, leases, and record-keeping. Specifically, the 

“Harvest Manner” specifies harvest cannot interfere with re-growth, cannot harvest “in such a way that 

representative harvest samples contain more than 15% holdfast by weight”, and must leave an upright 

shoot with “an absolute minimum length of 127 mm (5 in.) above the holdfast in non-leased areas” or as 

indicated in the lease management plan (Rock Weed Harvesting Regulations 1996)6

. In Maine, a Fishery 

Management Plan for Rockweed makes recommendations for minimum cutting height, designated noharvest areas, and harvester training (Maine Department of Marine Resources 2014); however, the plan 

has not been enacted to date. Washington Department of Natural Resources is responsible for marine 

macroalgae harvests, where harvest for sale or barter is not allowed on public or private land; in other 

words, the commercial harvesting of macroalgae is prohibited. Rules for hand harvesting, daily per 

person weight limits, and cutting heights are listed. Harvest of kelp and other marine macroalgae are 

regulated by the California Department of Fish and Wildlife and require a license. Regulations designate 

87 kelp beds, some of which are open to all harvesters, some are available for lease, and some are 

closed. Eelgrass and surfgrass are prohibited from harvest. Harvesting is prohibited in state marine 

reserves and state marine parks. Regulations stipulate that harvesters “may not cut attached kelp at a 

depth greater than four feet below the surface of the water at the time of cutting”, and that the kelp 

harvest plan must identify how harvesters will avoid “1. repetitive harvest from individual giant kelp 

plants; 2. harvest of bull kelp from those portions of kelp beds that contain both giant kelp and bull kelp; 

and 3. harvest of giant kelp near sea otter rafting sites used by female sea otters with dependent pups” 

(CDFW 2014). 

In Scotland, “licensing of wild harvesting activities ... provides a means to manage negative 

environmental impacts” (Scottish Government 2016). The absence of accurate assessments of marine 

macroalgae biomass can impede efforts to determine harvest volumes that would have limited 

environmental impact. “To our knowledge, there are no recent estimates of the wild seaweed standing 

stock of the UK nor of the potential stock that could be sustainably harvested” (Capuzzo and McKie 

2016). Similarly, “very little research has been carried out in Northern Ireland on the direct and indirect 

effects of harvesting on biodiversity and coastal processes” (Environment and Heritage Service 2007). 

There is a “lack of specific information on the carrying capacity of marine ecosystems to support 

seaweed harvesting and mariculture” (Ibid). 

6 Some of these provisions, such as minimum cutting height and holdfast content for Ascophyllum nodosum, have 

been noted as potentially inadequate to protect not only regeneration of the target species, but also to mitigate 

ecosystem-wide effects of harvesting. “An overharvest of Ascophyllum could lead to an undesirable level of 

habitat loss at a landscape scale. This is an important perspective which has not been stressed in earlier 

assessments of the Ascophyllum harvest in Nova Scotia.” (Vandermeulen 2013) 

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In Norway, regulations state that “importance shall be attached to the following in the management of 

wild living marine resources and genetic material derived from them: a) a precautionary approach, in 

accordance with international agreements and guidelines, b) an ecosystem approach that takes into 

account habitats and biodiversity, and c) effective control of harvesting and other forms of utilisation of 

resources” among other factors (Marine Resources Act 2008). The Act states in Section 16 The Conduct 

of Harvesting Operations: 

All harvesting and other utilisation of wild living marine resources shall be carried out as in such 

a way as to minimize impact. 

The Ministry may adopt regulations on the conduct of harvesting operations, including 

provisions on the following: 

a) the periods when harvesting is permitted and times for departure from port, 

b) the number of vessels from different vessel groups that may harvest at the same time in an 

area, 

c) prohibition of harvesting in certain areas, of certain species or using certain types of gear, 

d) the design, marking, use and tending of gear and other devices used in connection with 

harvesting, 

e) the maximum or minimum permitted sizes of individual organisms, and requirements for part 

or all of the harvest to consist only of males or females, 

f) permitted bycatches, 

g) the design and use of harvesting gear to reduce damage to species other than the target 

species. ((Directorate of Fisheries 2008) 

It should be repeated that some countries have limited or no regulations on macroalgal harvests, and 

the extent to which countries with regulations have the capacity to fully enforce them is not known. 

The United States has no specific federal regulations on macroalgal harvests. 

A number of third-party standards on sustainable seaweed harvesting offer non-regulatory options for 

verification of environmental stewardship goals, and these were outlined in the board’s previous 

discussion document on this topic. The Aquaculture Stewardship Council-Marine Stewardship Council 

(ASC-MSC) sustainable seaweed standards indicate that there are environmental impacts to harvesting 

seaweed, hence the need for/benefit to certification. Their guiding principles state that “seaweed 

harvesting ... must be conducted in a manner that does not lead to depletion of the exploited wild 

populations”. Harvesting must additionally “allow for the maintenance of the structure, productivity, 

function and diversity of the ecosystem (including habitat and associated dependent and ecologically 

related species) on which the activity depends.” (ASC-MSC 2020) 

It is important to note that the regulations typically focus on regrowth of the harvested species, with 

such conditions as cutting height, holdfast restrictions, or repeat harvest guidelines. While those 

parameters are important, “generally, the management focus is on the regeneration of the seaweed 

resource itself, with no or limited consideration of other species that are associated with the target 

species and may therefore be affected by bycatch or habitat loss and alterations” (Lotze et al. 2019). 

NOSB Fall 2019 Marine Materials Panel 

In order to gain a deeper understanding of the topic from a range of stakeholders, the board convened 

an expert panel in fall 2019 panel to evaluate the environmental impacts of marine macro algae 

harvesting for crop fertility inputs and to explore possible means of mitigating harm. The panel was 

composed of 2 scientists specializing in marine ecology and seaweed, 1 certifier, and 1 harvester. The 

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questions posed to were synthesized from public comment and NOSB members. Panelists were asked 

to identify and focus on those questions that best related to their experience and expertise. 

Questions for the Scientists and a Summary of Their Responses in Italics: 

1. Stakeholders have pointed out the need for a definition for the term “sustain”. Current NOP 

standards for protecting environmental resources rest largely on the terminology of “maintain 

or improve”, while the wild crop standard uses the word “sustain”. The NOP regulations do not 

define this term. §205.200 requires that crop producers “maintain or improve the natural 

resources of the operation”. §205.207(b) requires that wild crops be “harvested in a manner 

that ensures that such harvesting or gathering will not be destructive to the environment and 

will sustain the growth and production of the wild crop”. How can the NOP define, measure, 

and verify the phrases “not destructive to the environment” and “sustain the growth and 

production” as related to wild harvested marine macroalgae? 

a. Biomass is indicative of abundance of dependent organisms and measurable; 

architecture is more challenging to assess, but could be done intermittently. 

2. Could practice standards or guidelines be created that are sufficiently broad to cover the wide 

geographic distribution and differences in marine ecosystems while being simultaneously 

specific enough to provide adequate protection of marine algae and the ecosystem functions 

they afford? 

a. Conservative guild level guidelines, but may require species specificity. 

3. What are the environmental implications of taking no action? 

a. Given the rate of ocean change, the paucity of data on many of these systems, and 

tendency for overexploitation of marine resources, a cautionary approach is warranted. 

Additionally, aquaculture is an alternative to meet demand. 

4. Define an efficient, science-based method for measuring existing biomass to establish a 

baseline. How would this be measured post-harvest? Is there existing data from established 

harvest regions? 

a. We reviewed several developing remote sensing and genetic techniques, in addition to 

standard visual assessments. Validation and training required. 

5. For all algae, what are the best methods for harvesting that minimize the impact on the 

recovery of the population of the harvested species and maintain ecosystem function and 

services? What would be measured and what benchmarks would be set? Who should 

determine the methods/benchmarks? 

a. Benchmarking of harvesting approaches (e.g., holdfast minimums, no trawling). 

6. Are there some species that are so important to ecosystem structure and function that harvest 

should not be permitted at all? 

a. Coralline algae should be considered as off-limits to harvesting because of their life 

history characteristics and ecological importance. 

7. Should there be protected areas that are off limits to harvesting? Should seasonal restrictions 

be considered? 

a. Yes and Yes! 

8. What is an acceptable level of bycatch? Should this be assessed on a species by species basis? 

Are there any bycatch species that could prevent harvesting in an area altogether? 

a. Harvest using least destructive and most selective gear; implement bycatch monitoring. 

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Questions for the Certifier and Harvester: 

1. What methods are currently being used by certifiers and harvesters to verify environmental 

goals and avoidance of harm when certifying marine algae to the wild crop standard for 

livestock feed, human consumption, or as a crop input? 

2. Are certifiers adequately trained to certify marine algae? What could be done to address any 

deficiencies in knowledge and training? 

3. What concerns exist regarding the NOP’s regulatory authority to require organic certification of 

a crop production input ingredient? 

4. Are government regulatory structures in place to ensure habitat protection from overharvesting of marine algae? Should marine algae harvesting be permitted (under the organic 

regulations) where those regulations are weak or non-existent? 

5. If biomass assessments are made pre- and post-harvest, who should perform them? 

6. Who would monitor compliance and enforce management standards? 

7. Should the NOSB propose requiring organic certification of marine macro algae crop input 

ingredients, create an annotation, or explore other methods to ensure that environmental 

criteria are met? 

The expert panel provided the board with much-needed information on harvesting methods, 

certification concerns and areas for standards, the biology and ecology of marine macroalgae, and 

recommendations on future work. The harvester testified about his company’s many years of research 

on harvesting impacts and management plans enacted to minimize them. Annual surveys are 

conducted to establish proper harvest quotas. The certifiers addressed current certification of “kelp” as 

an agricultural product in organic livestock feed and emphasized that additional training for certifiers is 

needed, as was proposed in NOP 5027-1. They certify six operations to the wild crop standard for “kelp” 

harvesting. 

The scientists testified that marine macroalgae are ecosystem engineers providing habitat to other 

species, that harvesting reduces biomass and structure, and the extent of impact depends on harvesting 

methods. In some cases, seaweeds can recover. When clear-cut, it can take decades for recovery. They 

suggested a balanced view of desired ecosystem services from marine macroalgae. They affirmed that it 

was possible to create generalizable harvest parameters that could include baseline biomass 

assessments, minimum cutting heights and holdfast removal, and prohibitions on trawling. 

Proposal: 

Through its previous discussion documents, the board variously explored either requiring organic 

certification of macroalgae ingredients as a means of monitoring the environmental impact of harvests 

or an annotation in the National List that would achieve a similar result. There is resistance among 

some stakeholders to requiring organic certification due to concerns about a slippery slope for other 

natural inputs. On the other hand, there are species that are currently being certified organic for human 

consumption or livestock feed that are also used for crop fertility inputs. Additionally, there has been 

concern that requiring organic certification without specifying additional harvest parameters could lead 

to excessive variation in interpretation of the wild crop standard between certifiers. 

Some were apprehensive that verification could increase the cost of these inputs for farmers. Public 

testimony by one certifier noted that of the 19 crop inputs they approve containing aquatic plant 

extracts, 7 already contain certified organic plant extracts. A quick search for certified organic kelp meal 

revealed a number of products containing certified organic Ascophyllum nodosum. When compared 

with kelp meal products containing the same species that was not certified organic, there were 

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instances in which the product containing certified organic Ascophyllum nodosum was cheaper than the 

product containing Ascophyllum nodosum that was not certified organic. 

After significant consideration, it was decided that an annotation with specific wording about harvest 

procedures was a desirable and achievable goal. In consultation with the NOP, it was determined that 

language requiring verification within the annotation itself was not feasible; however, that does not 

diminish the requirement to follow the annotation. 

Although not a condition of the annotation, some harvesters and/or processor may seek verification. 

This could be done in a number of ways, including through a “material evaluation program” similar to 

the material evaluation requirement for High-Nitrogen Liquid Fertilizers (HNLF) explained in NOP 

Guidance 5012. A sample fee schedule for a material evaluation program can be viewed at the Organic 

Materials Review Institute and varies according annual gross sales for the company, the type of product 

being reviewed, and additional situations. Verification could also potentially be achieved through 

organic certification, with the certifier inspecting to the annotation harvest parameters as well as the 

wild crop standard. 

This annotation applies only to the raw marine macroalgal ingredient, not the resulting product. 

Companies harvesting the marine macroalgae would be responsible for harvesting according to the 

annotation parameters. Moreover, if the harvester chose to certify their macroalgae harvest, the 

ingredient list could state that the marine macroalgae ingredient was certified organic, i.e. “USDA 

Organic Ascophyllum nodosum”. If a producer opted to undergo a material evaluation program, the 

macroalgae would be product-verified and listed by that material review organization (producers can be 

individual harvesters or companies hiring independent contract harvesters). 

While there would be some increased cost for producers who decided to certify their macroalgae or 

have it reviewed through a material evaluation program, this is not dissimilar to the cost farmers and 

handlers bear when electing organic certification for their products. Moreover, a number of harvesters 

are already certifying all or part of their macroalgal harvests. There may be uncertified harvesters 

already harvesting to the annotation parameters for whom acquiring verification would not necessitate 

significant changes to their practices. 

This is a complicated subject and one the board has worked on for over five years. Differing views on 

the need for action exist. Finding the correct means of addressing harvesting has involved important 

exchanges between the board and stakeholders. The annotation must be broad enough to cover the 

range of species, geographies, and harvest methods while simultaneously being specific enough to be 

useful and feasible. 

The Materials Subcommittee is proposing an annotation to the organic regulations stipulating harvesting 

parameters for marine macroalgae used in crop fertilizers, providing a science-based process and 

parameters to ensure that harvesting limits harm to the environment. The annotation wording came 

about through review of previous public comments, in looking at the Marine Materials Fall 2019 panel’s 

scientists’ recommendations, and in conversations with Dr. Robin Hadlock Seeley (Shoals Marine 

Laboratory, Faculty, University of New Hampshire and Cornell University). The draft annotation was 

then sent to the two scientist seats on the panel –Dr. Allison Schmidt (Dalhousie University, Professor, 

Department of Biology) and Dr. Nichole Price (Bigelow Laboratory for Ocean Sciences, Senior Research 

Scientist)—and they collaborated to make additional edits. 

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The draft language was shared with the certifier on the panel, Chris Grigsby (MOFGA Certification 

Services, Director) and the harvester, Dr. Raul Ugarte (Acadian Seaplants, Senior Manager Resource 

Science). Comments said the annotation should include not only biomass and architecture, but also the 

other species in the community. Additionally, it was suggested that a more feasible and ecologically 

sound metric than biomass and architecture returning to pre-harvest levels might instead be harvest 

rates below the annual rates of regeneration. 

The annotation language was next reviewed, and edits were suggested, by Dr. Michael Graham at Moss 

Landing Marine Laboratories and Co-/Managing-Editor, Journal of Phycology. The draft annotation 

language was subsequently sent to 18 different marine scientists across the US, Canada, and Chile to 

solicit their feedback on feasibility, adequacy, and suggested edits. They came via public and 

stakeholder comments and recommendations and through referrals from scientists contacted about last 

fall's expert panel. Those that replied were: 

• Dr. Susan Brawley, University of Maine, Professor School of Marine Sciences 

• Dr. Dan Reed, University of California Santa Barbara, Marine Science Institute 

• Dr. Robert DeWreede, University of British Colombia, Professor Emeritus Botany 

• Dr. Thomas Mumford, Marine Agronomics LLC, Retired from the Washington Department of 

Natural Resources 

• Dr. Heike Lotze, Dalhousie University, Professor Department of Biology 

• Dr. David Garbary, St. Francis Xavier University, Professor of Biology 

• A colleague of Dr. Pam Krone, Monterey Bay National Marine Sanctuary 

• Dr. Jennifer Smith, University of California at San Diego Scripps Institution of Oceanography, 

Professor of Marine Biology 

• Dr. Brian Beal, University of Maine, Professor of Marine Ecology & Director of the Marine 

Science Field Station 

• Dr. Alejandro Heriberto Buschmann Rubio, Universidad de los Lagos, Professor 

• Glyn Sharp, Retired from Department of Fisheries and Oceans-Nova Scotia 

Broadly speaking, there was general agreement about the annotation and suggestions for revisions 

(with the exception of one scientist who thought it was satisfactory and feasible as written and one who 

expressed concern that it was too broad to be effectively applied to specific regions or species). Edits 

were made to the proposed language based careful analysis of the feedback received from the various 

scientists, including Drs. Schmidt, Price, and Ugarte from the Fall 2019 Expert Panel. 

The “prohibited harvest areas” section was amended to specify established public and private 

conservation areas and to include sanctuaries and preserves. “Trawling” was refined based on near 

universal feedback to “bottom trawling”. Given a range of views on language referring to “reproductive 

individuals”, the wording was changed to reflect the diversity of species and their reproductive 

characteristics by rohibiting practices that prevent reproduction of the population. Additional language 

was added based on suggested wording from Dr. Ugarte regarding sufficient propagules to maintain the 

population. Phrasing about maintaining ecosystem functions was also added. Original wording stating 

that bycatch should be “minimized” was recognized as subjective, and so the wording was changed to 

“prevented” and “eliminated” in the case of special status species. One scientist noted that the absence 

of bycatch can demonstrate an unhealthy marine community. Monitoring practices would need to be 

clarified in guidance. 

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The language that drew the greatest amount of feedback was that regarding biomass and architecture 

returning to pre-harvest levels prior to repeat harvesting. Questions arose about how to measure this. 

Monitoring and data collection to measure biomass and architecture can take place using a variety of 

methods, including remote sensing, drones, GIS maps, genetic techniques, transect sampling, and visual 

assessments. Guidance would be needed to clarify how and when sampling should occur. It was 

recommended that “height” should be an average with some variation. One scientist noted that 

commercial harvesting affects the architecture of some species, making it challenging to require a 

complete return to pre-harvest levels. It was suggested that guidance on how different types of species 

are harvested would be needed. Establishing fully accurate pre-harvest levels was deemed difficult. 

One commenter said that hand raking of some species is preferred over mechanical harvest as it reduces 

in incidence of cutting to minimum allowed heights, which can negatively impact the biological 

community. An initial limited test harvest was recommended, along with subsequent designated strip 

harvesting. It is not the intent of the language to stop harvesting to establish a baseline measurement. 

All of these are points that should be evaluated in guidance. 

The second version of the annotation with incorporated comments was sent back to all those who 

originally provided feedback. This time there was more agreement from the scientists that the changes 

had improved the annotation. Roughly half felt it was adequate as edited. A few had suggestions for 

additional edits. Thus, a third version of the language was drafted based on feedback and in 

consultation with four of the scientists, paying close attention to improvements that could gain the 

broadest degree of consensus within the stakeholder community. Importantly, the scientists represent 

a range of specialties in marine macroalgae. It was noted that storms and natural succession can impact 

biomass and architecture. Ice scouring of rock ledges and storm events affect biomass and architecture 

in the case of Ascophyllum nodosum. The earlier annotation language specified a return to pre-harvest 

levels. Preharvest measures of biomass and architecture in ice-scoured or winter storm-impacted areas 

may not adequately form the basis of sufficient recovery. Consequently, the wording was further 

developed to clarify that repeat harvest cannot reoccur until the biomass and architecture approach 

that of undisturbed natural stands of the target species in that area. This recognizes variability in site 

specific conditions. 

All of the scientists were sent the final annotation wording. The vast majority agreed with the final 

wording as it was written, as well as the process of developing the language. Three provided additional 

comments, and most of those were incorporated into the final language. The two outstanding issues 

raised that will need to be explored in guidance are how to measure architecture (though length and 

circumference can be measured in a quadrant for intertidal species, this is more challenging for subtidal 

species; whether estimated measurements are adequate and how to define this should also be 

considered), and the importance of the relationship between species size and age. The final annotation 

wording reflects of a diverse spectrum of scientific feedback, collaboration, and support. The 

subcommittee thanks all those who participated in its crafting, particularly Dr. Allison Schmidt and Dr. 

Nichole Price for their tremendous time, effort, and expertise in helping guide this language 

development. 

Adoption of this annotation should be accompanied by a NOP-appointed scientific task force to 

elaborate additional guidance and instruction to certifiers, with particular focus on providing speciesspecific parameters7

. The task force could identify the top three to five species used and provide 

7 Modifying existing third-party standards that address environmental impact of seaweed harvesting or using them 

as a reference point could be explored by the task force. 

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recommendations for their unique biological and geographical characteristics. A periodically updated 

living document, reviewed at sunset intervals, would serve to address changes to the annotation as 

needed and to promote consistency in interpretation and application. Adoption of this annotation 

should be followed by a lengthy phase-in period of five years to allow for industry adaptation. Material 

review organizations and certifiers would need to use staff qualified to evaluate the harvest against the 

annotation parameters, for harvesters seeking certification or product verification. Task force-driven 

guidance should detail needed areas for training. 

These parameters reflect values and science around marine macroalgae harvest the board supports. 1) 

Protected conservation areas should not be used for harvest of organic fertility inputs. 2) Bottom 

trawling is prohibited because of its potential for damage to the surrounding ecosystem, thus preventing 

the harvest of most coralline algae (as recommended by the scientists on the Fall 2019 Expert Panel) 

because of its slow growth rate8

. 3) Harvesting should not interfere with reproduction for the continued 

growth and ecosystem functions of the species. 4) Although harvesting affects the architecture of some 

species, biomass or percent cover and architecture (density and height) must be allowed to approach 

the biomass and architecture of undisturbed natural stands of the targeted species in that area before a 

subsequent harvest so that ecosystem function interruption is minimized, to the extent possible. 5) 

Prevention and monitoring of bycatch are important to avoiding unnecessary mortalities associated with 

the harvest. 

It is not intended that every harvest be monitored as that would be impossible to oversee, just as 

organic inspectors are not present for every action taken during a farm’s growing season. As with the 

entire organic label, trust is involved. Finally, harvesters must comply with all local, state, federal, and 

tribal regulations, permits, and jurisdictions. 

§205.601 Synthetic substances allowed for use in organic crop production 

1) This proposal suggests an annotation to §205.601 (j)(1) requiring (proposed annotation changes are in 

red): 

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 does 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. 

Harvest Parameters - “Prohibited harvest areas: established conservation areas under federal, state, or 

local ownership, public or private, including parks, preserves, sanctuaries, refuges, or areas identified as 

important or high value habitats at the state or federal level. Prohibited harvest methods: bottom 

trawling and harvest practices that prevent reproduction and diminish the regeneration of natural 

populations. Harvest practices should ensure that sufficient propagules9

, holdfasts, and reproductive 

8 In the Mediterranean, Barbera et al. (2003) note “that maerl beds are non-renewable resources and cannot 

sustain direct exploitation”, a species and region cited in the 2016 TR as used in organic fertilizers. Lotze et al. 

(2019) state “Trawling and dredging generally entrain a wide range of non-target species and have the most 

damaging effects on seafloor habitats, including the seaweed canopy”. 

9 Definition of a propagule: a vegetative structure that can become detached from a plant and give rise to a new 

plant, e.g. a bud, sucker, or spore. 

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structures are available to maintain the abundance and size structure of the population and its 

ecosystem functions. Harvest timing: repeat harvest is prohibited until biomass and architecture 

(density and height) of the targeted species approaches the biomass and architecture of undisturbed 

natural stands of the targeted species in that area. Bycatch: must be monitored and prevented, or 

eliminated in the case of special status species protected by U.S. Fish and Wildlife Service or National 

Marine Fisheries Service." 

2) An additional listing is proposed at §205.602 prohibiting marine macroalgae unless produced in 

accordance with the following annotation (identical to that proposed for §205.601 (j)(1)) in order to 

address marine macroalgae used in non-synthetic products and therefore not covered by the annotation 

under Aquatic Plant Extracts. This prohibition, unless harvested in accordance with the annotation, 

would help safeguard that marine macroalgae harvested for and used in organic crop production do not 

harm the environment (proposed changes are in red): 

§205.602 Nonsynthetic substances prohibited for use in organic crop production. 

The following nonsynthetic substances may not be used in organic crop production: 

(j) Marine macroalgae (seaweed)--unless harvested in accordance to the following parameters: 

Non-commercial harvests for whole and unprocessed seaweed are exempt from these parameters. 

Harvest Parameters - “Prohibited harvest areas: established conservation areas under federal, state, or 

local ownership, public or private, including parks, preserves, sanctuaries, refuges, or areas identified as 

important or high value habitats at the state or federal level. Prohibited harvest methods: bottom 

trawling and harvest practices that prevent reproduction and diminish the regeneration of natural 

populations. Harvest practices should ensure that sufficient propagules10, holdfasts, and reproductive 

structures are available to maintain the abundance and size structure of the population and its 

ecosystem functions. Harvest timing: repeat harvest is prohibited until biomass and architecture 

(density and height) of the targeted species approaches the biomass and architecture of undisturbed 

natural stands of the targeted species in that area. Bycatch: must be monitored and prevented, or 

eliminated in the case of special status species protected by U.S. Fish and Wildlife Service or National 

Marine Fisheries Service." 

Public comment indicated some farmers in coastal regions harvest small amounts of marine macroalgae 

for on-farm, non-commercial use. Such harvests are exempt from this annotation. 

Conclusion: 

On issues where universal agreement does not exist, it is the board’s aim to pursue a middle ground 

approach where achievable. Given the strong calls for action on the one hand and statements that 

action is unnecessary on the other, this proposal reflects the best effort at compromise. Prohibition of 

the use of marine macroalgae in crop fertility inputs is not viable, nor is inaction on safeguarding marine 

ecosystems from the impacts of harvesting. This annotation does not prohibit marine macroalgae but 

provides scientifically sourced harvest parameters to protect the target species and its associated 

community. 

Much of organic agriculture is based on the precautionary principle. Similarly, this proposal prevents 

possible negative environmental impacts from commercial harvesting of marine macroalgae. The 

potential for a negative impact is sufficient to warrant a cautionary approach and was recommended by 

10 Definition of a propagule: a vegetative structure that can become detached from a plant and give rise to a new 

plant, e.g. a bud, sucker, or spore. 

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the scientists on the Fall 2019 Expert Panel. This proposal furthers the commitment to continuous 

improvement in organic farming by valuing marine macroalgae not simply as resources but also as 

integral species within complex ecosystems. 

In the presence of conflicting views and given evidence describing the environmental impacts of 

harvesting, this proposal seeks to ensure that the raw input ingredient, marine macroalgae used in crop 

fertility inputs, is not harmful to the environment by establishing harvest parameters created in 

collaboration with marine science experts in the field. The review of the literature demonstrates the 

possibility for multi-level environmental effects of harvesting marine macroalgae. Even where 

regulations exist, and they are not legislated in every country, they do not typically address effects on 

the community and ecosystem functions and instead focus on regrowth and recovery of the targeted 

species. The organic regulations, as noted in the earlier section on relevant areas of the rule, is 

concerned not only with single species impacts but also with ecological balance and biodiversity 

conservation. This proposal helps assure that marine macroalgae used in organic production is 

consistent with a system of sustainable agriculture. 

Subcommittee Vote: 

Motion to adopt the proposal on Marine Macroalgae in Crop Fertility Inputs 

Motion by: Emily Oakley 

Seconded by: Dave Mortensen 

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

Approved by Dave Mortensen, Subcommittee Chair to transmit to NOSB, August 11, 2020 

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National Organic Standards Board 

Policy Development Subcommittee 

Consent Agenda Discussion Document 

July 19, 2020 

Summary: 

The PDS is discussing the use of a consent agenda for voting on Sunset items that are similar, in an effort 

to save time at the NOSB meetings. 

Discussion: 

A consent agenda is a board meeting practice where similar agenda items are grouped into a single 

agenda item for voting purposes. All items under a consent agenda can then be approved in one action, 

rather than board members filing motions on each item separately. Using a consent agenda can save 

time. Many private and governmental boards use a consent agenda for generally non-controversial 

items that do not require much, if any, discussion before a vote. 

For the NOSB, reviews of substances with multiple listings on the National List where the two reviews 

are essentially the same could be grouped for voting. For example, ammonium carbonate and 

ammonium bicarbonate, or copper substances, could be grouped. The consent agenda process allows a 

board member, for any reason, to remove an item from the grouping for further discussion, and possible 

separate vote. However, if the items are not singled out for discussion they can be grouped for voting 

thereby saving time. To maintain transparency the process would only be used for similar, noncontroversial items. 

The Policy Development Subcommittee is seeking feedback from the full Board and public commenters 

to see if there is support for this change before pursuing it further. 

Subcommittee Vote: 

Motion to accept the discussion document on the use of a consent calendar 

Motion by: Rick Greenwood 

Seconded by: Jesse Buie 

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

Approved by Rick Greenwood, Policy Development Subcommittee Chair, to transmit to NOP August 9, 

2020 

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