National Organic Standards Board | Fall 2014 Meeting | Proposals & Discussion Documents

National Organic Standards Board Meeting

Galt House Hotel, Grand Ballroom C, Louisville, KY October 28-30, 2014 

Title Page

Materials Subcommittee | Dr. C. Reuben (Calvin) Walker, Chairperson 

Proposal: Fall 2014 Research Priorities 1

Discussion Document: Excluded Methods Terminology 9

Handling Subcommittee | Harold Austin, Chairperson

Proposal: Glycerin - petitioned for removal 19

Proposal: Whole Algal Flour - petitioned 29

Sunset 2015 Review: Gellan Gum 35

Sunset 2015 Review: Tragacanth 37

Sunset 2015 Review: Marsala 39

Sunset 2015 Review: Sherry 43

Sunset 2016 Summaries: 

Egg White Lysozyme, L-Malic Acid, Microorganisms, Activated Charcoal, Peracetic 

Acid, Cyclohexylamine, Diethylaminoethanol, Octadecylamine, Sodium Acid 

Pyrophosphate, Tetrasodium Pyrophosphate (TSPP)

49

Compliance, Accreditation, and Certification Subcommittee | Carmela Beck, Chairperson 

Discussion Document: Assessment of Soil Conservation Practices 57

Livestock Subcommittee |Tracy Favre, Chairperson

Proposal: Vaccines from Excluded Methods (GMO Vaccines) 61

Verbal Report: Aquaculture Review History (NO DOCUMENT) NA

Crops Subcommittee | Zea Sonnabend, Chairperson 

Verbal Update: Inerts (NO DOCUMENT) NA

Discussion Document: Contamination Issues in Farm Inputs Literature Review 73

Sunset 2015 Review: Sulfurous Acid 85

Sunset 2015 Review: Sodium Carbonate Peroxyhydrate 91

Sunset 2015 Review: Aqueous Potassium Silicate 95

Sunset 2016 Summaries:

 Ferric Phosphate, Hydrogen Chloride

103

TOC

National Organic Standards Board

Materials Subcommittee

Proposal: Research Priorities for 2014

August 26, 2014

Introduction

A Recommendation for a Framework to set Research Priorities was approved at the National Organic 

Standards Board (NOSB) meeting in May 2012. Part of that recommendation was that the priorities from 

the previous year of NOSB deliberations would be presented at each fall meeting. Therefore, we have 

collected suggested research topics from the NOSB Subcommittees and from suggestions within the public 

comments and present the top research priorities for approval this fall.

Each fall, after a recommendation is finalized by the NOSB, the Chair of the Board will make sure it is sent to 

the primary organic research funders such as NIFA, ARS, NRCS, and private foundations and other funders 

that may be identified. In addition all NOP staff, NOSB members and stakeholders can use the list for 

inspiring appropriate research. 

Background

The reasons for encouraging research into organic production systems are well discussed in the previous 

two Materials Subcommittee papers from fall 2011 and spring 2012. 

The recommendation that was passed recommends that potential topics be prioritized. The criteria for 

prioritization are for those topics that the NOSB believes will have the largest long-term impact on growth 

and integrity of organic agriculture. These criteria are not presented in order of importance, but will be 

evaluated by the Materials Subcommittee in selecting the top research needs. 

Criteria for research topics are:

• Persistent and chronic (i.e., perennial topics of debate and need)

• Challenging 

• Controversial (i.e., topics on which there are widely differing perspectives or for which there have 

been close NOSB votes)

• Nebulous (i.e., the research need is hard to identify but the organic agriculture need is clear). For 

example, improved methods of weed control.

• Lacking in primary research. That is, topics for which there is no active research being conducted, 

primarily relating to the criteria in OFPA for review of materials.

• Relevant to assessing the need for alternative cultural, biological, and mechanical methods to 

materials on the National List.

Research Priorities in 2012 and 2013

In 2012, the NOSB adopted research priorities and identified topics for future review. In 2013, the Materials 

Subcommittee proposed research priorities and identified topics for future review, but they were not 

adopted by the NOSB until spring of 2014 because the fall 2013 meeting was cancelled due to a 

government shut down. All of these topics, listed here, are still priorities.

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Research Priorities for 20121

Whole Farm Systems Research 

Evaluation of Copper Sulfate for Rice 

Evaluation of Antibiotics (Tetracycline and Streptomycin) alternatives 

Evaluation of Genetically Modified Vaccines (GMO) 

Organic Aquaculture 

Methionine Alternative 

Carrageenan 

Priorities for 20132

Whole Farm Systems

Alternatives to Antibiotics (Tetracycline and Streptomycin) for Fire Blight

Evaluation of Genetically Modified Vaccines (GMO)

Methionine Alternative

Organic Aquaculture

Aquatic Biodiversity

Herd Health

Pastured Poultry and Salmonella 

Commercial Availability Assessments 

Consumer Demand 

Fate of Genetically Engineered Plant Material in Compost 

Reduction of Genetically Modified Content of Breeding Lines 

Proposal: NOSB Research Priorities 2014

For 2014, the Subcommittee has added the topics below as priorities for research. In addition, the 

Subcommittee continues to support all research priorities identified in 2012 and 2013. 

Handling Subcommittee

Alternatives to Bisphenol A (BPA)

The Handling Subcommittee plans to take up the issue of whether to prohibit BPA in packaging material 

used for organic foods in light of mounting evidence that it may be harmful. There needs to be an increase 

in research about suitable alternatives for the linings of cans used for various organic products such as 

tomatoes, beans and soups.

1 2012 Other Topics for Future Review

Parasitism 

Mastitis 

Herd Health 

Plant Extract to organically control methane producing bacteria in livestock 

2 2013 Topics for Future Review 

Chlorine Alternatives

Sulfuric Acid Alternatives

Parasitism

Mastitis

Pneumonia

Page 2 of 104
This issue meets the following criteria in the NOSB research priorities framework:

• Persistent and Chronic

• Challenging 

• Lacking in Primary Research

Crops Subcommittee

Plant Disease Management

There is a need for research into plant disease management practices and alternative materials, particularly 

for the humid areas of the country, that decrease reliance on copper or other substances that might have a 

negative impact on the soil and health of workers. Pathogens include, but are not limited to: Alternaria, 

Erwinia, Pseudomonas, Xanthomonas, Cercospora, Colletotrichum, Cladosporium, powdery mildew, downy 

mildew, Phytophthora, Pythium, Mycosphaerella, Phomopsis, Taphrina, Elsinoe, Gnomonia, Fusicladium, 

Nectria, Phyllosticta, Diplocarpon, Albugo, Guignardia, Botrytis, Exobasidium, Entomosporium, Exobasidium, 

Pestalotia, Phoma, Cristulariella, and Monilinia fruticosa. 

Citrus greening, caused by the bacterium Candidatus Liberibacter, and spread by a disease infected Asian 

citrus psyllid, is an emerging problem. Promising avenues of research include disease-resistant varieties, 

predators and parasites and how they interact with approved materials, nutrition (calcium, boron, and 

nitrogen have been identified), and botanical oils. 

In particular, both biological control of plant diseases and bio-pesticides should be a research priority to 

support organic growers. A large body of research has shown that plant diseases caused by bacteria and 

fungi can often be prevented by the application of a non-pathogenic microorganism before infection 

occurs. Although much basic research has been done to identify microbial biological control agents, there 

is still a need for commercial development, field testing, and adoption by growers. Biological controls have 

been researched for late blight of potato and tomato (Phytophthora infestans), several diseases caused by

Botrytis cinerea, and powdery mildew (several species), controlled by mites, fungi, bacteria. 

Although many biological controls and bio-pesticides have been effective in research plots, they have often 

not succeeded commercially because they can’t compete with inexpensive synthetic chemicals used by 

non-organic farmers. Biological materials are often more expensive than conventional pesticides, and they 

need be applied before disease is apparent. In the past, there was little market for biological controls, 

because the organic acreage was limited. Now that organic acreage has increased, the market for 

alternative plant disease controls has also increased, which can spur commercialization of natural methods 

of disease control. The availability of biological controls for plant diseases can also make it more feasible 

for conventional farmers to transition to organic, thus benefitting organic consumers.

This topic meets all the criteria in the NOSB research priorities framework.

Soil Building Practices

Humates seem to fill a need for practices and materials that accelerate the development of organic matter 

in the soil, especially in the transition to organic practices. Are there other such practices and materials? 

Building soil health with nonsynthetic practices is integral to organic management practices. 

This meets all the criteria for research support.

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Mitigation Measures for Residues in Compost

Residues of pesticides in compost material are a problem that requires research, according to OMRI. 

Because of the importance of compost to organic management systems, research is needed on types of 

mitigation measure that are efficacious, identification of problematic feedstock (e.g. cotton-based materials 

and yard waste), types of corrective action, and if thresholds for allowable residues are established, testing 

guidelines are required.

This meets all the criteria for research support.

Organic No Till

Organic no-till practices are a subset of whole farm systems. Unlike chemical-based no-till systems, organic 

no-till builds biodiversity and increases soil health. And, compared to tilled organic systems, organic no-till 

preserves and builds more soil organic matter, conserves more soil moisture, reduces soil erosion and 

requires less fuel and labor. Some of the questions raised for whole farm systems in general relate to 

organic no-till practices: How does biodiversity contribute to pest and disease resistance? What is the 

relationship between nutrient balancing fertilization practices and microbial life in the soil and susceptibility 

or resistance to pests? In addition, research into organic no-till should address practices that lead to 

effective weed control with minimum interference with the crop.

This issue meets the following criteria in the NOSB research priorities framework:

• Persistent and Chronic

• Challenging 

• Lacking in Primary Research

Materials/GMO Subcommittee: Seed Purity from GMO Research Needs

How contaminated with GMOs is at-risk seed?

There is a lack of data on how much crop contamination is occurring from seeds as a vector compared to 

drift or handling practices.

This issue meets the following criteria in the NOSB research priorities framework:

• Persistent and chronic (i.e., perennial topics of debate and need)

• Challenging 

• Controversial (i.e., topics on which there are widely differing perspectives or for which there have 

been close NOSB votes)

• Nebulous (i.e., the research need is hard to identify but the organic agriculture need is clear). For 

example, improved methods of weed control.

• Lacking in primary research. That is, topics for which there is no active research being conducted, 

primarily relating to the criteria in OFPA for review of materials.

Research on integrity of breeding lines and foundation seed and ways to mitigate small amounts of 

genetic presence in breeding lines. 

A concurrent question is: Are public germplasm collections that house at-risk crops contaminated?

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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 researched.

This issue meets the following criteria in the NOSB research priorities framework:

• Persistent and chronic (i.e., perennial topics of debate and need)

• Challenging 

• Controversial (i.e., topics on which there are widely differing perspectives or for which there have 

been close NOSB votes)

• Nebulous (i.e., the research need is hard to identify but the organic agriculture need is clear). For 

example, improved methods of weed control.

• Lacking in primary research. That is, topics for which there is no active research being conducted, 

primarily relating to the criteria in OFPA for review of materials.

Risk Reduction from Off-Target Exposure to Non-Permitted Materials

What we have found to be true is that organic farmers can gather a great deal of vital information about 

how to reduce the impact of contamination from the development of a sound organic system plan (OSP) 

and through the knowledge shared by their USDA organic certification agent. 

However, even if the best OSP plan is intact, organic farms may still be at risk from the impact of 

contamination from agricultural farms utilizing GMOs and their pesticide treatment. 

Successful coexistence suggests that organic farms can exist without harm, consistent with consumer and 

farmer choice to avoid or minimize contamination. Avoidance or minimization may be achieved through 

users of GMOs and pesticides adopting practices that prevent non-permitted materials in OSPs from 

causing involuntary exposure by moving off their target site. 

Research efforts are needed on behalf of organic stakeholders, NGOs, USDA (Natural Resources 

Conservation Service, National Institute of Food and Agriculture, Risk Management Agency, etc), LandGrant Institutions, and in coordination with partner agencies, such as the U.S. Environmental Protection, 

state Departments of Agriculture, and others, on alternative strategies that can 1) develop and examine 

management practices that enhance public and farmer awareness of at-risk organic farms, 2) identify 

effective practices and standards that will prevent non-target impacts of materials used on farms not 

certified organic, and 3) best methodologies to provide information and training. 

Critical and timely questions include: Are there strategies in place or that could be put in place that can 

provide information, training, to enhance public awareness of at-risk organic farms? Which methodologies 

are successful in ensuring risk reduction from materials not permitted under organic standards?

This issue meets the following criteria in the NOSB research priorities framework:

• Persistent and chronic (i.e., perennial topics of debate and need)

• Challenging 

• Controversial (i.e., topics on which there are widely differing perspectives or for which there have 

been close NOSB votes)

• Nebulous (i.e., the research need is hard to identify but the organic agriculture need is clear). For 

example, improved methods of weed control.

Page 5 of 104
• Lacking in primary research. That is, topics for which there is no active research being conducted, 

primarily relating to the criteria in OFPA for review of materials.

Livestock Subcommittee

Mastitis

Mastitis, which has been listed for two years as a topic for further review, is the second priority of the 

Livestock Subcommittee. Mastitis is a disease that results in inflammation of the mammary gland. It is 

generally associated with dairy animals. It can be caused by bacteria, physical injury, etc. Mastitis is one of 

the most common and expensive diseases of dairy cattle. It can result in reduced milk production, 

discarded milk, treatment, and veterinary expenses. An urgent need exist for looking at ways to reduce 

mastitis in dairy herds. The research needs include the areas of herbal treatment of mastitis and 

management practices, and consider the efficacy of organic treatments used by, recommended to, and 

available to organic producers. 

This issue meets the following criteria:

• Persistent and chronic (i.e., perennial topics of debate and need)

• Challenging 

• Lacking in primary research on mastitis prevention. That is, topics for which there is no active 

research being conducted, primarily relating to the criteria in OFPA for review of materials.

• Relevant to assessing the need for alternative cultural, biological, and mechanical methods to 

materials on the National List.

Parasitism

Parasitism of livestock, which has been listed for two years as a topic for further review, is the third priority 

of the Livestock Subcommittee. The control of internal and external parasites is important to animal 

welfare, growth, reproduction, and production. In organic production, the control of parasites is critical. 

The use of antibiotics is prohibited. A limited number of substances are available to control parasites. 

Antibiotics are not allowed in organic livestock production for growth, reproduction, and production. 

Antibiotics can be used on sick animals. However, these animals cannot be sold as organic. A critical need 

exist to explore ways to find materials for the control of internal and external parasites in organic livestock 

operations. Research is needed that considers the efficacy of organic treatments used by, recommended to, 

and available to organic producers.

This issue meets the following criteria:

• Persistent and chronic (i.e., perennial topics of debate and need)

• Challenging 

• Controversial (i.e., topics on which there are widely differing perspectives or for which there have 

been close NOSB votes)

• Lacking in primary research on parasite prevention. That is, topics for which there is no active 

research being conducted, primarily relating to the criteria in OFPA for review of materials.

• Relevant to assessing the need for alternative cultural, biological, and mechanical methods to 

materials on the National List.

. 

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Pneumonia

Pneumonia was a topic for further review in 2013, and is the fifth priority of the Livestock Subcommittee. 

Pneumonia denotes a swelling of the lungs. Pneumonia is rare when animal populations and densities are 

low. In the winter, animals are housed or gather more closely together, increasing the concentration of 

pathogens in their environment. Confinement and higher animal densities result in increased air 

temperatures, humidity, and condensation, which are beneficial conditions for pathogen survival and 

transmission. Pneumonia in a herd or flock means animals are not performing up to their maximum 

potential, production costs are higher, labor is increased, and food product quality is compromised. 

Responsible animal caretakers know it is their duty and responsibility to address animal welfare concerns 

and ensure a safe and healthy environment for their animals. Research is needed that considers the efficacy 

of organic treatments used by, recommended to, and available to organic producers.

This issue meets all of the research criteria.

Herd Health 

Herd health was a topic for further review in 2012 and a priority issue in 2013. It is the sixth priority (tied 

with aquaculture) of the Livestock Subcommittee. The assessment of preventative organic practices to 

improve organic livestock health are critical and of high importance. These include general animal health as 

it relates to diseases prevention, uterine infections in peri-parturient animals, growth, and identification of 

vaccine types, nutrition, and production systems. It thus encompasses some of the more specific issues and 

is also related to the 2012 and 2013 priority of whole farm systems research. 

This issue meets all of the research criteria.

Plant Extracts

Use of plant extracts to organically control methane producing bacteria in livestock was a topic for further 

review in 2012 and is the Livestock Subcommittee’s ninth priority. Plant extracts that could be 

environmentally and economically beneficial to organically control methane producing bacteria in the 

animal could lead to practices that reduce methane. Reduced methane results in more energy going to the 

animal from a given amount of feed. This reduces total feed required to meet nutritional needs and 

particularly helps grazing animals which have high protein availability.

This topic meets the following research criteria:

• Challenging 

• Nebulous (i.e., the research need is hard to identify but the organic agriculture need is clear). For 

example, improved methods of weed control.

• Lacking in primary research. That is, topics for which there is no active research being conducted, 

primarily relating to the criteria in OFPA for review of materials.

• Relevant to assessing the need for alternative cultural, biological, and mechanical methods to 

materials on the National List.

Call for Researchers

We hope that this information will be useful for researchers in many fields to defend and solicit funds for 

research that benefits organic production and handling. There is an ongoing need for organic research on a 

wide range of issues. There is a wealth of data and research on topics of interest to the organic community. 

However, there is a paucity of research on our current issues conducted in an organic environment. 

Therefore, we invite the public to comment on these topics, to circulate this widely, and to recommend 

Page 7 of 104
that funders also prioritize these topics. Please submit comments on funders who might want to remain 

informed of research opportunities in organics.

Committee Vote

Motion to adopt the proposal on NOSB Research Priorities for 2014. 

Motion by: Jay Feldman

Seconded by: Zea Sonnabend

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

Second Subcommittee Vote

Motion to amend the NOSB Research Priorities for 2014 by adding the section "Risk Reduction from OffTarget Exposure to Non-Permitted Materials."

Motion by: Jennifer Taylor

Seconded by: Jay Feldman

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

Approved by C. Reuben Walker, Subcommittee Chair, to transmit to NOSB August 27, 2014

Page 8 of 104
National Organic Standards Board 

Materials/GMO Subcommittee 

Second Discussion Document on Excluded Methods Terminology

August 22, 2014

Introduction and Scope

A year ago the project was started to grapple with the definition of "excluded methods" in the USDA 

organic regulations. This is the definition that appears in the rule (7 CFR 205.2; Terms Defined):

Excluded methods. A variety of methods used to genetically modify organisms or influence their 

growth and development by means that are not possible under natural conditions or processes and 

are not considered compatible with organic production. Such methods include cell fusion, 

microencapsulation and macroencapsulation, and recombinant DNA technology (including gene 

deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when 

achieved by recombinant DNA technology). Such methods do not include the use of traditional 

breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture. (Federal

Register / Vol. 65, No. 246 / Thursday, December 21, 2000 / Rules and Regulations p. 80639)

The definition was based on the best efforts of the NOSB in 1995 and has provided adequate guidance to 

prohibit the use of the most obvious genetically engineered crops such as herbicide-resistant corn and 

soybeans and Bt cotton, as well as prohibit processing inputs such as genetically engineered yeasts and

enzymes. However, this definition contains terms that are unclear, outdated and incomplete in light of new 

methods of recombinant DNA technology that have emerged since the definition was first adopted in 1995.

In 2011 and 2012 a number of confusing issues came before the NOSB and to the NOP which made it 

necessary to revisit the definition. These include genetically engineered vaccines for livestock, the use of 

cell fusion within plant families to create male sterility in brassica hybrids, whether or not GMOs could be 

used in biodegradable bioplastic mulches, and the question of whether mutated algae might therefore be 

genetically engineered. The current definition is inadequate to clarify these issues.

In 2013, NOSB first Discussion Document on excluded methods,1 each of the terms in the above definition 

was discussed further, terms involved in traditional breeding, such as mutagenesis and conjugation, were 

defined and discussed, and new terms that may be considered to be genetic engineering were brought up. 

No conclusions were suggested except that there is a need to do more work on the subject. The discussion 

questions posed asked commenters to suggest principles on which to base GE distinctions, to offer opinions 

on what terms were and were not excluded methods, and to bring forward new terms that may need 

consideration. A list of the terms brought up is in Appendix 1.

The NOSB received about 16 substantive public comments on the first discussion document, and also many

general comments about keeping GMOs out of organic agriculture. The intention of this Second Discussion 

Document is to summarize the substantive public comments received on the previous one and to propose 

some further questions to move forward the issue of strengthening the Excluded Methods Terminology. 

The goal, as this effort continues, is to have concrete determinations for the National Organic Program, 

Accredited Certifiers, and organic producers to use in keeping GMOs out of organic food and farms.

1 NOSB 2013. Excluded Methods Terminology Discussion Document. April 2013. 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5102656

Page 9 of 104
This Discussion Document builds onto where the other one left off. The sections below titled "Relevance to 

Rulemaking", "Comments on Definition(s), Principles, and Criteria", "Process or Product" and "European 

Approaches" are all summaries of information that was submitted through public comments. The 

subsequent "Discussion" section includes the NOSB subcommittee analysis of the issues brought up. Finally, 

the questions at the end aim at collecting more input from the public on how to proceed. 

Note: The Subcommittee recognizes that the usual public comment time period is not long enough to fully 

circulate, digest, discuss and respond to these issues. We strongly urge the NOP to create the ability for 

longer comment periods as was adopted by the NOSB in its Public Communications Recommendation on 

April 10, 2013. 

Relevance to Rulemaking

In our first Discussion Document we did not state whether the subcommittee was proposing a change in 

the regulation or to address this subject through guidance. 

Several commenters pointed out the language from the Senate report that accompanied OFPA, which was 

quoted in the first proposed rule. (62 Fed. Reg. 65850, 65875)

While the OFPA mandates that the Secretary develop organic standards, it is silent on the issue of 

genetically engineered organisms (GEOs) and their products. However, the accompanying Senate 

report language states that ‘‘as time goes on, various scientific breakthroughs, including 

biotechnology techniques, will require scrutiny for their application to organic production. The 

committee is concerned that production materials keep pace with our evolving knowledge of 

production systems.2

’’

This reference from the Senate report was quoted in the first proposed rule somewhat out of context. It 

appears to have been used by the congress as justification for a registration program for organic materials 

that was subsequently removed from the conference report. However, it implies the same need for 

flexibility as quoted below from the rule’s preamble. 

From the preamble to the current rule (65 Fed. Reg. 13512, 13521): 

We recognize that the phrases, ‘‘natural conditions or processes’’ and ‘‘not considered compatible 

with organic production,’’ may be subject to interpretation.

....

we recognize that industry and consumer expectations regarding the products of these techniques 

in organic production systems may evolve. We believe that, taken together, these phrases allow for 

a degree of flexibility to ensure that our regulations continue to accurately reflect industry practices 

and consumer preferences. In cases where questions may arise regarding a specific technique, we 

anticipate that such questions would be resolved by the Administrator based on recommendations 

from the NOSB.

2 U.S. Senate. 1990. Food, Agriculture, Conservation and Trade Act of 1990 - Report to Accompany S2830. Rpt 101-357, 

101st Congress, 2nd Session. Government Printing Office, Washington, DC.

Page 10 of 104
The Materials/GMO subcommittee has discussed this issue and believes that NOP Guidance is the most 

appropriate form for any clarifications and interpretations to be made regarding excluded methods, for the 

very reasons mentioned by the Senate and the NOP.

Comments on Definition(s), Principles, and Criteria

This section is in two parts. Part 1 summarizes the public comment regarding principles and criteria to 

consider in clarifying or revising the excluded methods definition further. Part 2 consists of the additional 

terms brought up by commenters with some of their definitions provided. Appendix 1 contains the terms 

that were defined and discussed in the first Discussion Document.

1. Other definitions related to Excluded Methods to draw from – 

A. The Cartagena Protocol definitions (CFS public comment):

"Living modified organism" 

“[a] living modified organism is defined as any living organism that has a combination of genetic 

material obtained through the use of modern biotechnology. 

"Modern Biotechnology" (also adopted by Codex Alimentarius): 

(i) in vitro nucleic acid techniques, including recombinant DNA and direct injection of nucleic acid 

into cells or organelles, or (ii) fusion of cells beyond the taxonomic family that overcomes natural, 

physiological reproductive or recombination barriers, and that are not techniques used in 

conventional breeding and selection.”3

 

"While this language is more specific, the underlying theme of the definition is the same However, the 

distinctions presented by the Cartagena protocol definition could also be used to inform a newly created 

guidance document.4

" 

B. Proposed new definition of Excluded Methods (Dag Falck public comment): 

Methods that change the genetic material of an organism through recombining DNA5 through 

laboratory methods and in ways that are not dependent on the use of conjugating, sexual or 

asexual reproduction methods, including transgenic (intraspecific or intergeneric), or cisgenic 

(intrageneric) transfers of genes. Methods not included in the definition are: other natural, classical, 

or modern breeding techniques that depend on movement of genes only through a conjugative, 

sexual or asexual reproduction method with parent gene material from within the same taxonomic 

family6

. 

C. Ethical Criteria (FiBL public comment): 

1. The genome is respected as an indivisible entity and technical/physical invasion into the plant 

genome is refrained from (e.g. through transmission of isolated DNA, RNA, or proteins). 

2. The cell is respected as an indivisible functional entity and technical/physical invasion into an 

isolated cell on growth media is refrained from (e.g. digestion of the cell wall, destruction of the cell 

nucleus through cytoplast fusions). 

3. The ability of a variety to reproduce in species-specific manner has to be maintained and 

technologies that restrict the germination capacity of seed-propagated crops are refrained from 

3 Convention on Biological Diversity. 2013. The Cartagena Protocol on Biosafety. Available at: 

http://bch.cbd.int/protocol. 4 Center for Food Safety 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070 5 http://en.wikipedia.org/wiki/Recombinant_DNA.

6 Dag Falck, Nature's Path 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070

Page 11 of 104
(e.g. Terminator technology).7

D. Operational criteria (Rich Theuer public comment): 

It is very helpful that you set forth these operational criteria for implementing the phrase “without 

the use of excluded methods:”

1. Keeping genetically modified organisms out of organic livestock feed, crops, and food; and

2. Preventing the introduction of novel proteins into soil and water ecosystems.

This is the kind of guidance that certifiers, producers, and handlers can execute.8

2. Terms not in the prior Discussion9

The descriptions provided here are our best attempt to summarize very technical issues. More information 

can be found in the cited sources. While some of these techniques may seem to obviously be consistent 

with the existing excluded methods definition, others are not, and some may or may not be depending on 

specifics. These are presented only as examples to give readers the context and descriptions of some terms 

that will be evaluated in our future work. 

o Doubled Haploid Technology – A breeding technique used to create homozygous inbred lines in one 

generation instead of the many required by traditional methods. Used widely in wheat, canola and corn, 

it involves the following steps: emasculation, pollination, 2,4-D treatment, embryo culture, and 

colchicine treatment. It often involves crosses between wheat and corn.

o Targeted genetic modification (TagMo) – a collective term for the zinc finger nuclease techniques that 

create DNA double-stranded breaks at specific genomic locations that can then be used to alter the 

target gene. The genetic modification would not necessarily involve transfer of nucleic acids from 

another species, nor would it be easy to detect in a final product. It is unclear how these would be 

regulated in the U.S.

o "FasTrack" – a breeding scheme that has so far been used in plums where an early-flowering gene from 

poplar is inserted into a plum tree. When the plum flowers in less than a year, it is crossed with nontransgenic varieties carrying desirable traits. Markers are used to identify the right traits and, at the end 

of the breeding program, only those are selected that do not have the transgene.

o Synthetic Biology – practitioners generate new DNA sequences the way computer programmers write 

code, creating new life-forms. Called by one of its founders "genetic engineering on steroids10". So far it 

has been used to generate a yeast that produces a malaria drug and to make synthetic vanilla.

o Cisgenics – A genetic modification of a recipient organism with a gene (cisgene) from a crossable 

(sexually compatible) organism. This is not always interpreted as a prohibited technique because such 

crossing may be able to occur in nature.

o Intragenesis – genetic modification of a recipient organism that involves the insertion of a reorganized, 

full or partial coding region of a gene, often with a promoter and/or terminator from another gene of 

the same or crossable species. 

7 FiBL Research Institute of Organic Agriculture 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070

8 Richard Theuer 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070 9

 Among many sources used for definitions are the following: Kuzma J, Kokotovich A (2011) Renegotiating GM crop 

regulation. EMBO reports 12: 883–888; Podevin N, Devos Y, Davies HV, Nielsen (2012) Transgenic or not? No simple 

answer! EMBO reports 13: 1057 – 1061; Waltz E (2012) Tiptoeing around transgenics. Nature biotechnology 30: 215–

217; Wikipedia for each term.

10 Phillpot, Tom 2014. Now your Food Has Fake DNA in It. Mother Jones 

http://www.motherjones.com/environment/2014/08/food-fake-dna-synbio-vanilla-ice-cream

Page 12 of 104
o Plastid transformation – Plastids are semi-autonomous organelles within higher plants with a small, 

highly polyploid genome. Technology has been developed for genetic modification of this genome 

independent of nuclear DNA. Currently used commercially in tobacco, and widely researched.11

o Gene silencing via RNAi and DNA methylation – Interfering with the regulation of gene expression 

through inserting methyl groups onto RNA and DNA that then supress the expression of the gene. Can 

occur in nature, but is used as a recombinant technique in cancer research and plant breeding.

o RTDS (Rapid Trait Development System) – the next generation precision gene editing technology 

developed by Cibus company. Similar to the oligonucleotide targeted DNA modification (below) it does 

not leave behind transgenic material, only uses it to create a change in a precise area of a gene.

o Site directed mutagenesis via oligonucleotides, zinc finger nuclease (ZFN) – an introduction of 

recombinant DNA through transient molecules that are identified by zinc-finger nucleases, with or 

without a repair template. The techniques resemble transgenesis but the end products are similar to, 

and indistinguishable from, conventionally bred plants.

o Agro-infiltration – Similar to the zinc finger nuclease technique above, but using an Agrobacterium to 

inject several foreign DNA molecules into the plant cell.

o Reverse breeding – A process that uses several other techniques such as RNAi to suppress meiotic 

recombination, tissue culture, and then double haploidization to create parental lines that are 

homozygous to use in breeding F1 hybrids.

o Embryo transfer of animals – a technique used in animal breeding. It involves inducing superovulation 

of donor with gonadotropins, artificial insemination, recovery of embryos, isolation and storage of 

embryos, transfer of embryos back into animals, and then pregnancy.

o Marker Assisted Selection (MAS) – a process whereby a marker is used for indirect selection of a 

genetic trait. Markers are usually DNA but they can be morphological (such as seed color) or 

biochemical (specific enzymes). Very commonly in use is the antibiotic resistance marker so that any 

population can be exposed to antibiotics and the organisms that survive have the marker. This 

technique may not necessarily be considered genetic engineering in itself, but can be used in 

conjunction with other transgenic techniques or involve inserting recombinant markers.

Process or Product?

Public commenters offered several papers from Europe that discussed the difference between a processedbased standard for GMOs and a product-based standard. This is relevant to the current discussion because

the Federal Rule for organic is based on a process-based approach to all of organic production, yet there 

are some areas where the process is intertwined with the product or a quantitative tool can be used to 

assess the validity of a process approach. See discussion section for more. 

"The US oversight system was built mostly around the idea that GM plants should be regulated on the basis 

of characteristics of the end­product and not on the process that is used to create them.”12

"The first challenge is to make sure that regulatory frameworks remain fit for purpose. However, 

frameworks that use process-based definitions as a trigger for regulatory oversight might not be functional 

over time (Sidebar B). Several authors have argued that new biotechnology-based plant breeding 

techniques might not fit into, or might rapidly outgrow, the established defi- nitions for GMPs [COGEM 

11 Maliga, P. 2004. Plastid transformation in higher plants. Annu Rev Plant Biol. 2004;55:289-313. 

http://www.ncbi.nlm.nih.gov/pubmed/15377222

12 Kuzma J, Kokotovich A (2011) Renegotiating GM crop regulation. EMBO reports 12: 883–888

Page 13 of 104
2006 (9), Morris SH 2008 (10) as cited in original] or other narrowly defined product definitions [Kuzma, 

J.2011 (8), Ledford, H. 2011 (11), Waltz, E. 2012 (12) as cited in original]. NPPs (new plant products) blur the 

sharp distinction between GMP and non-GMP, and introduce a new continuum between genetic 

engineering and conventional breeding. Process-based legislation will require not only updates to the lists 

of new biotechnological plant breeding techniques but also debate on their classification as GMP or nonGMP. However, such flexibility is rarely evident in regulatory frameworks.13 

"Sidebar B | Process-based compared with product-based regulatory frameworks14

Process-based regulatory frameworks

Argentina, Brazil, the EU and many other countries have put new process-based regulatory 

systems in place to regulate the use of genetically modified organisms (GMOs), as the 

techniques used for their production were thought to raise specific safety concerns. In these 

jurisdictions, a GMO is mainly characterized by the transformation techniques used in its 

production. The definitions of GMOs used by these countries are often partly or fully based on 

those put forward by international organizations such as the United Nations Food and 

Agricultural Organization (FAO) and international treaties such as the Cartagena protocol.

Product-based regulatory frameworks

Canada and the USA opted to regulate all plants or products with new traits developed either 

through genetic engineering or any other plant breeding techniques under the same, yet 

existing, regulatory system [26,27]. The transformation techniques were not considered 

inherently risky. Therefore, the focus of product-based regulatory systems is on the risks of 

products and new traits or attributes introduced into a plant, rather than the method of 

production." 

European Approaches to Classifying Genetic Manipulation Methods

The EU has made the distinction between "traditional" breeding methods and conventional (transgenic) 

breeding.15 

FiBL submitted a comment that included a chart that describes methods with a yes/no column for 

compatibility with organic standards for both plants and animals. The NOSB could work on something 

similar and the methods that receive consensus can be incorporated into guidance. A subset of this chart is

presented here as an example:

16

Method Excluded (by 

FiBL)

Why

Embryo rescue No / YES in 

animals

Plants: Embryo is maintained on artificial media, 

but no genetic changes occur. Animals: Embryo 

transfer on organic farms is rejected, therefore 

also embryo rescue

Microinjection YES Invasive technique that violates integrity of a cell

Biolistic device YES Invasive technique that violates integrity of a cell

13 Podevin N, et. al. (2012) Transgenic or not? No simple answer! EMBO reports 13: 1057 – 1061 14 ibid. 15 (Directive 2001/18/EC. and an EU background paper ‘Current plant breeding techniques’, DOC.XI/464/92.

- Clemens van de Wiel, Jan Schaart, Rients Niks & Richard Visser, “Traditional plant breeding methods”, 2010 - 

http://edepot.wur.nl/141713)

16 FiBL Research Institute of Organic Agriculture 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070

Page 14 of 104
Somaclonal 

variation

YES, if 

artificially 

introduced

Somaclonal variation results from mutation and is 

identified during in vitro culture, but might not 

necessarily be introduced by the tissue culture...

Transposons Yes if 

artificially 

introduced

Transposons are a regulatory element influencing 

gene silencing and mutation rate. Transposons can 

be artificially introduced by genetic engineering, 

see genetic engineering

Transduction No Is a natural phenomenon

This type of evaluation in Europe has led to an independent effort to define and certify "Organic Varieties"

and even Organic Animal Breeding.

17 In this idea (which has not yet been written into any regulations), only 

approved non-GMO plant breeding methods would be used to create what could be certified as an Organic 

Variety or Organically Bred Animal. In this country, a parallel idea has been floated that organically grown 

seeds be held to different criteria regarding GMOs than conventional seeds, even those not called GMO.18 If 

such ideas were adopted, then a set of organic plant breeding standards could be developed, or at least 

organically produced varieties may be distinguished from other varieties, such as not being able to have 

used cell fusion for Cytoplasmic Male Sterility (CMS) or double haploid technologies.

Discussion 

Definition(s), Principles, and Criteria

The subcommittee likes the definitions regarding biotechnology from the Cartagena Protocol for several 

reasons. First, it is more specific than the current definition regarding recombinant DNA and direct 

injections or fusion between families. Second, it is well accepted internationally and therefore provides the 

NOP with good justification for adopting into guidance. Third, it provides a better framework than the 

existing definition to further elaborate the various technologies that would be allowed as well as those 

which would be prohibited. This will be discussed further below.

The definition proposed by Mr. Falck in B above also attempts to make it clearer, but is not as widely 

accepted or known.

The criteria and principles in comments C and D above are valid points that the subcommittee appreciates 

the input on. The points raised in D as operational are accepted as part of our goals for how to interpret the 

principles and definition adopted, but they would be the subsequent step after the broader issues of 

definition and principles. Perhaps other operational criteria would be helpful as well. Operational criteria 

for determining acceptability of crop inputs derived from GMO feedstocks and/or fermenting organisms 

(potentially including corn gluten meal, corn steep liquor, and biodegradable mulch, for example), 

disinfectants like alcohols, and processing aids would be appropriate in guidance to certifiers and materials 

review organizations and/or in the materials listings. The subcommittee will be looking at this point in 

developing future work plans. 

We are posing further discussion questions on some of the criteria raised in the FiBL comment (point C 

above) to see if these criteria are useful and realistic.

17 Neff, A.S. & Augsten, F. 2009. Assessing Reproductive and Breeding Techniques in Organic Agriculture using Cattle 

Breeding as an Example. FiBL Discussion Paper. Submitted with FiBL public comment to docket AMS-NOP-12-0070 18 Still, Andrew, 2013. Adaptive Seed Catalog and Seed Ambassadors Blog. http://www.seedambassadors.org/

Page 15 of 104
Process or Product?

Since the whole underpinning of the U.S. organic regulations is a process-based system, it would make 

sense that this concept carry over to defining excluded methods. This is indeed the basis of the current 

definition. However, this is not currently how U.S. government agencies regulate GMOs, as noted above, or

handle other issues such as pesticide residues or water quality standards. 

While some commenters seemed to feel that there might be advantages to a product-based definition, 

such a structural revision is beyond the sope of this current effort. Therefore, the rest of this discussion will 

assume continuing a process-based approach.

European Classification Concepts applied in the U.S.

It would seem to make sense to try to distinguish between traditional and transgenic breeding techniques 

for both plants and animals. The FiBL suggestion of doing this through a chart has some strong benefits, 

including:

o the chart could be developed over time, with the terms everyone agrees to adopted first and then 

the more controversial ones hammered out over time.

o such a chart can follow logically from the Cartagena Protocol definition to indicate recombinant 

DNA, direct injection, cell fusion outside of families and other guidance provided by that definition 

that is somewhat lacking in the current definition.

o A chart such as this would be easier for the NOP to maintain as instruction or guidance and would

not be as lengthy as a list of crop varieties and inputs. Additionally, it does not have to be updated 

as frequently.

o It maintains a transparency to all stakeholders that is now somewhat lacking in how GMOs are 

regulated.

o It gives ACAs clear instruction on how to evaluate seeds, vaccines, microorganisms and other 

potential GMOs.

At this juncture, before we even start to create a table of excluded methods terms, we invite input from the 

public on whether or not this is a worthwhile effort and any ideas for how to implement such an idea.

Unresolved Issues

Exploring this issue has brought to the attention of the subcommittee that engineered genetic 

manipulation of plant breeding materials has already occurred in many of the crop varieties that are 

currently being used in organic farming. A partial list:

• Disease resistant tomatoes (embryo rescue to introduce resistance genes)

• wheat and barley (double haploid technology using wheat and corn crosses along with 

embryo rescue and colchicine gene doubling)

• hybrid corn parent lines (double haploid to get homozygosity in 1 generation)

• Seedless tangerines and mandarins (mutations through irradiation)

• Brassica hybrids (cell fusion from radish traits)

19

Many of these techniques that were used in initial crosses that have now passed down through many 

generations may not be traceable any longer. There are also many new varieties in development that will 

strongly challenge any definitions or regulatory scheme. Without a revised definition and some guiding 

19 for detail on this issue, please see: Myers, Jim 2014. in Proceedings from the 7th Organic Seed Growers conference.

https://seedalliance.org/index.php?mact=DocumentStore,cntnt01,download_form,0&cntnt01pid=30&cntnt01returni

d=139

Page 16 of 104
principles to use for past and future determinations about excluded methods, there may not be effective

ways to regulate either past or future techniques and their products.

Discussion Questions 

The Materials/GMO ad hoc Subcommittee is seeking response from the organic community on the issues 

presented in this discussion. A few of the particular questions to address are:

1. Are the definitions presented from the Cartagena Protocol an appropriate basis for guidance to further 

enable NOP and the NOSB to sort out terminology? (on page 3)

2. Among the criteria suggested, we would like feedback on the ones mentioned below and ask whether

there are any other important criteria to use in genetic engineering determinations.

o Technical/physical invasion into the plant genome is refrained from (e.g. through transmission of 

isolated DNA, RNA, or proteins).

o The cell is respected as an indivisible functional entity and technical/physical invasion into an 

isolated cell on growth media is refrained from (e.g. digestion of the cell wall, destruction of the cell 

nucleus through cytoplast fusion).

o The ability of a variety to reproduce in species-specific manner has to be maintained and 

technologies that restrict the germination capacity of seed-propagated crops are refrained from 

(e.g. Terminator technology).

3. Would it be a good approach to continue a process-based evaluation of the terms and techniques, 

determine whether they are a result of genetic engineering, and then list both the GE and non-GE terms in 

a chart maintained by the NOP in the public record? If so, please offer suggestions on how this could be 

implemented. If not, please suggest any alternatives. 

4. Are there terms or methods not included in appendix 1 that should be added to the discussion? Briefly 

explain. 

Subcommittee Vote

Motion to adopt the proposed Second Discussion Document on Excluded Methods Terminology

Motion by: Zea Sonnabend

Seconded by: C. Reuben Walker

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

Page 17 of 104
Appendix 1

Terms defined and discussed in the first Discussion Document. They are presented in the same order they 

were in the document.

In current definition of Excluded Methods: 

Cell Fusion

Protoplast Fusion

Somatic hybridization

Micro-encapsulation

Macro-encapsulation 

Recombinant DNA

Gene Deletion

Genetic Engineering

Mutagenesis (mutation breeding)

Conjugation, genetic

Fermentation 

Hybridization 

 Hybrid 

Nucleic Acid Hybridization

In Vitro Fertilization 

Tissue Culture

Cell Culture

Primary and Batch Cell Culture

Not in Definition of Excluded Methods

Silencing 

Embryo Rescue

Microinjection

Biolistic device

Somaclonal variation

Transposons

Transduction

Approved by C. Reuben Walker, Subcommittee Chair, to transmit to NOSB August 27, 2014

Page 18 of 104
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Glycerin 

August 27, 2014

Summary of Proposed Action:

The petitioner has requested removal of Glycerin (CAS Number 56-81-5) from 205.605(b) (synthetic 

materials for handling), stating that there is now sufficient quantity of organically produced glycerin and 

that synthetic glycerin is no longer required. The petitioner believes that the process of microbial 

fermentation that is used to produce organic glycerin is a superior method for the production of organic 

glycerin because it uses only mechanical and biological processes as required in §205.270(a) without the 

use of allowed synthetics listed in §205.605(b). Further, they state “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. This is why glycerin 

should be removed from the National List; in order to encourage organic agricultural production.”

There has been a significant amount of confusion regarding the classification of Glycerin as synthetic/nonsynthetic because of the various methods by which it can be manufactured. In April 2013, the National 

Organic Program (NOP) issued draft guidance on classification of materials that should provide some 

clarification on the status of glycerin produced by these various methods. However, as of this date, this 

guidance document has not been issued in its final form. Further, the Handling sub-committee recognizes 

the irony that Glycerin produced from organic source materials using hydrolysis could be classified as both 

organic and synthetic.

Additionally, public written and oral comments presented for the spring 2014 NOSB meeting indicated that 

the removal of Glycerin from 205.605(b) could have significant negative impact on natural flavorings used 

in organic products, due to the fact that Glycerin is often used as a carrier. The comments generally 

expressed concern regarding the commercial availability of sufficient quantities of organically produced 

Glycerin to meet the demand for these natural flavorings. With the current listing for Flavors at 205.605(a), 

the annotation is as follows: “non-synthetic sources only and must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.” During the Handling sub-committee discussion, 

the question came up as to whether current practice is to allow Glycerin – from hydrolysis of fats and oils –, 

which is currently classified as synthetic, to be used as a carrier in natural flavorings. Therefore, the 

Handling Subcommittee seeks feedback on the current practices regarding Glycerin in natural flavors. 

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 sub-committee, after significant discussion, is proposing the listing of Glycerin at 205.606, and 

removal of Glycerin from 205.605(b). Based upon the draft classification of materials document, the form 

of Glycerin that would qualify for listing at 205.606 would include Glycerin produced by microbial 

fermentation of carbohydrate substances. It is the Handling sub-committee’s intent with this 

recommendation to provide incentive to increase the amount of organic Glycerin used, while also 

recognizing the possibility of issues around commercial availability. 

Page 19 of 104
Background

Glycerin is a viscous fluid that has a sweet taste. It is used in a wide variety of products including food, 

cosmetics, medical and industrial applications. As listed at 205.605(b), Glycerin is formulated from 

hydrolysis of fats and oils. Per the Technical Review (line 122), there are a variety of methods for 

manufacture of Glycerin from hydrolysis of fats and oils: 

Table 2 Processes for producing glycerin by hydrolysis of fats and oils

Lemmens Fryer’s Process Oil or fat is subjected in an autoclave to the conjoint action of heat 

and pressure (about 100 PSI) in the presence of an emulsifying and 

accelerating agent, e.g. zinc oxide or hydroxide (sodium hydroxide 

can be substituted) for about eight hours. The strong solution of 

glycerin formed is withdrawn and replaced by a quantity of hot, 

clean and preferably distilled water equal to about one third to 

one fourth of the weight of the original charge of oil or fat and 

treatment continued for an additional four hours. The dilute 

glycerin obtained from the latter part of the process is drawn off 

and used for the initial treatment of the further charge of oil or fat.

Budde and Robertson’s Process The oils or fats are heated and mechanically agitated with water 

and sulphuric acid gas, under pressure in a closed vessel or 

autoclave. The advantage claimed for the process are that the 

contents of the vessel are free from foreign matter introduced by 

reagents and need no purification; that the liberated glycerin is in 

the form of a pure and concentrated solution; that no permanent 

emulsion is formed and that the fatty acids are not discolored.

Ittner’s Process Coconut oil is kept in an autoclave in the presence of water at 70 

atmospheres pressure and 225-245oC temperature and split into 

fatty acids and glycerin, both being soluble under these conditions 

in water. The glycerin solution separates in the bottom of the 

autoclave. The aqueous solution contains at the end of the 

splitting process more than 30 percent glycerin.

Continuous High Pressure 

Hydrolysis 

In this process a constant flow of fat is maintained flowing upward 

through an autoclave column tower against a downward counterflow of water at a pressure of 600 PSI maintained at temperature 

of 480-495o

F. Under these conditions, the fat is almost completely 

miscible in water and the hydrolysis take place in a very short time. 

The liberated fatty acids, washed free of glycerin by the downward 

percolating water, leave the top of the column and pass through a 

flash tank while the liberated glycerin dissolves in the downward 

flow of water and is discharged from the bottom of the tower into 

the sweet-water storage tank.

Additionally, per the petitioner “Saponification of natural fats and oils, a process of hydrolyzing the 

agricultural products fat or oil with water (steam) under pressure (high-pressure splitting) or with a solution 

of sodium carbonate, sodium hydroxide, or potassium hydroxide (traditional process) to produce synthetic 

glycerin and fatty acids. The steam process is described in the 1995 Technical Advisory Panel Report on 

glycerin. The alkali process is the traditional process used to saponify fats and oils.” Hydrolysis of fats and 

oils does change the chemical properties of the source material, and therefore it is considered a synthetic. 

Page 20 of 104
Per the petition: Four general methods of commercial glycerin production are or have been used:

1. Chemical synthesis by hydrogenolysis of carbohydrates (21 CFR 178.3500; 21CFR 172.866)) or by 

synthesis from propylene (mentioned in the 1995 Technical Advisory Panel report on glycerin). 

Neither chemical synthetic process has ever been deemed worthy of serious consideration for use 

in organic.

2. Biodiesel production comprises reaction of natural fats and oils – triglycerides – with methyl alcohol 

or ethyl alcohol to produce the methyl or ethyl esters of fatty acids. These synthetic fatty acid 

esters are the diesel fuel. Glycerin is a synthetic waste byproduct of this chemical process. The 

commercialization of the biodiesel process in the past few years has created an enormous supply of 

biodiesel glycerin that has largely displaced chemical synthesis from propylene. In fact, the low cost 

of biodiesel glycerin has resulted in commercialization of processes to use it as a raw material to 

produce epichlorohydrin, acrolein, propylene glycol, and other organic chemicals. There are safety 

concerns with biodiesel glycerin, discussed in Section B-11. 

3. Saponification of natural fats and oils, a process of hydrolyzing the agricultural products fat or oil 

with water (steam) under pressure (high-pressure splitting) or with a solution of sodium carbonate, 

sodium hydroxide, or potassium hydroxide (traditional process) to produce synthetic glycerin and 

fatty acids. The steam process is described in the 1995 Technical Advisory Panel Report on glycerin. 

The alkali process is the traditional process used to saponify fats and oils. The three sources of alkali 

used in this process are included in the National List. Glycerin produced by saponification was 

recommended by the NOSB in 1995 for inclusion on the National List with the annotation 

“produced by hydrolysis of fats and oils.” It is currently included on the National List as a synthetic 

nonagricultural substance at §205.605(b) [and also for livestock used at §205.603(a)(12)]. Certified 

organic glycerin is being produced by saponification of organic fats and oils.

4. Microbial fermentation of carbohydrate substances (analogous to citric acid currently included in 

the National List at §205.605(a)) to produce non-synthetic glycerin. This production method is 

briefly mentioned generically in the 1995 TAP Report and referred to in the Merck Index 

monograph on glycerol (glycerin), which cites a U.S. Patent No. 3,012,945 issued to Noda in 1961 

for yeast fermentation to produce glycerin. Currently, microbial fermentation of organic cornstarch 

by the yeast Candida krusei is used commercially to produce certified organic glycerin as well as 

non-synthetic non-organic glycerin.

As stated in the TR: Glycerin can be produced organically by the process of microbial fermentation using 

only mechanical and biological processes as required in §205.270(a) without the use of allowed synthetics 

listed in §205.605(b). In addition, certified organic glycerin can be produced by hydrolysis of organic fats 

and oils using either steam splitting or traditional saponification with a catalytic amount of an alkali (sodium 

carbonate, sodium hydroxide, or potassium hydroxide) on the National List. Glycerin, produced organically 

by fermentation is an agricultural product as defined in 7 CFR 205.2, since it is a processed product 

produced from an agricultural commodity, e.g. cornstarch (TR lines 130 – 131). There are currently 21 

USDA certified organic operations supplying glycerin for organic food or cosmetic products. Specific 

supplier information (TR Table Line: 674)

Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes X No ☐ N/A

3. Compatibility & Consistency ☐ Yes X No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes X No ☐ N/A 

as Organic (only for §205.606)

Page 21 of 104
Substance Fails Criteria Categories 2, 3, 4 (see attached checklist)

Subcommittee Action & Vote

Classification Motion: Motion to classify Glycerin produced by microbial fermentation as agricultural.

Motion by: Tracy Favre 

Seconded by: Harold Austin 

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

Listing Motion: Motion to list Glycerin at 205.606

Motion by: Tracy Favre 

Seconded by: Harold Austin 

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

 Listing Motion: Motion to remove Glycerin – produced by hydrolysis of fats and oils - from 205.605(b)

Motion by: Tracy Favre 

Seconded by: Harold Austin

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

Approved by Harold Austin, Subcommittee Chair, to transmit to NOSB August 27, 2014 

Page 22 of 104
NOSB Evaluation Criteria for Substances Added To the National List

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

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use or 

misuse of the substance? 

[§205.600(b)(2), [§6518(m)(3)]

X Wide variety of uses for food and industrial 

applications. Long-term history of safe use, 

TAP indicates no incidence of industrial 

poisoning. Glycerin should not come into 

contact with a strong oxidizing agent. 

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the substance? 

[§6518(m)(3)]

X For current listing: Manufactured from 

hydrolysis of fats and/or oils using steam 

splitting. Theoretically possible to have spill 

of oils, but unlikely. 

Fermentation methods: Unlikely

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X However, the petitioner claims that the 

residue from biodiesel production is used in 

the manufacture of glycerin, and one could 

argue that growing corn for biodiesel does 

have an impact on biodiversity.

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X

5. Is there undesirable persistence or 

concentration of the material or breakdown 

products in the environment? [§6518(m)(2)] 

X Per Environmental Working Group (EWG), 

there seems to be no persistence in the 

environment. TAP and other documentation 

have no comment.

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added to it? 

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

§6518(m)(4), 205.600(b)(3)]

X Glycerin is considered GRAS and has a long 

history of safe use in a wide variety of food, 

cosmetic and medical applications. It is 

metabolized as a carbohydrate in the body.

7. Is the substance, and any ancillary 

substances, GRAS when used according to 

FDA’s good manufacturing practices? 

[§205.600(b)(5)]

X See above comment.

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 (b)(5)]

X Manufactured from hydrolysis of fats and oils 

using steam splitting and then concentrated 

using distillation. Fermentation methods

include isolation of cornstarch from organic 

corn.

Page 23 of 104
Category 2. Is the Substance Essential for Organic Production? Substance: Glycerin 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X X As currently listed it is not considered 

agricultural. However, the petitioner makes 

the argument that it should have originally 

be listed at 205.606 since if it is 

manufactured using steam, then it should be 

considered agricultural. The fermentation 

method could be considered agricultural 

since it is manufactured using isolated 

cornstarch from organic corn. 

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Per the petition: “Saponification of natural 

fats and oils, a process of hydrolyzing the 

agricultural products fat or oil with water 

(steam) under pressure (high-pressure 

splitting) or with a solution of sodium 

carbonate, sodium hydroxide, or potassium 

hydroxide (traditional process) to produce 

synthetic glycerin and fatty acids. The steam

process is described in the 1995 Technical 

Advisory Panel Report on glycerin. The alkali 

process is the traditional process used to 

saponify fats and oils. The three sources of 

alkali used in this process are included in the 

National List.” 

Hydrolysis of fats and oils does change the 

chemical properties of the source material. 

Fermentation methods: The process for 

producing organic glycerin by microbial 

fermentation from carbohydrate substrates 

begins with organic corn from which 

cornstarch is isolated. The cornstarch is

treated with enzymes to hydrolyze the starch 

and liberate glucose. The glucose is then 

fermented with an appropriate 

microorganism to produce glycerin. The 

glycerin is purified by passing through ionexchange columns to remove inorganic 

elements required for growth of the 

microorganism and through activated 

charcoal to remove color and impurities.

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

X Hydrolysis is the opposite to condensation. A 

large molecule is split into smaller sections 

by breaking a bond, adding -H to one section 

and -OH to the other.

Page 24 of 104
sources? 

[§6502(21)]

The products are simpler substances. Since it 

involves the addition of water, this explains 

why it is called hydrolysis, meaning splitting 

by water. 

A-B + H2O --> A-H + B-OH 

(http://www.biotopics.co.uk/as/

condensation_and_hydrolysis.html)

For fermentation method, see above.

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X The process of hydrolysis is a naturally 

occurring process, but this material is 

manufacturing using high heat and pressure. 

Incidentally, all (food) digestion reactions are 

examples of hydrolysis, and the involvement 

of water is often not appreciated. Generally 

these reactions are controlled by enzymes 

such as carbohydrases, proteases, lipases, 

nucleases, more specific examples of which 

are fairly well known. 

(http://www.biotopics.co.uk/as/

condensation_and_hydrolysis.html) 

For fermentation, see above.

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X Petitioner claims to have a fully organic 

version manufacturing using a fermentation 

process. See petition, 

(http://www.ams.usda.gov/AMSv1.0/

getfile?dDocName=STELPRDC5101924) 

Per the TR: Glycerin can be produced 

organically by the process of microbial 

fermentation using only mechanical and 

biological processes as required in 

§205.270(a) without the use of allowed 

synthetics listed in §205.605(b). In addition, 

certified organic glycerin can be produced by 

hydrolysis of organic fats and oils using 

either steam splitting or traditional 

saponification with a catalytic amount of an 

alkali (sodium carbonate, sodium hydroxide, 

or potassium hydroxide) on the National List. 

7. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600(b)(6)] 

X Glycerin is used in a wide variety of products 

including food, cosmetics, industrial and 

medical. It is a strong humectant. In organic 

food products it is used to improve texture, 

increase volume and is a major carrier for 

flavorings and colorings.

Page 25 of 104
8. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

Alcohols could be used a carriers for 

flavorings. And there are myriad other 

materials that could have a similar functional 

use in other formulations (such as softening 

and mouth feel in ice creams, keeping baked 

items soft, etc.) but glycerin is unique in that 

it can serve in all these functions.

9. Are there any alternative substances? 

[§6518(m)(6)] 

X Glycerin manufactured from petroleum 

products, glycerin from saponification of fats 

and oils and fermentation methods.

10. Is there another practice (in farming or 

handling) that would make the substance 

unnecessary? [§6518(m)(6)]

X X Given the wide use of glycerin, it is likely that 

there are substitutes for particular uses, but 

it is unlikely that any one material would 

work in all the applications where glycerin is 

used. 

11. Have the ancillary substances associated 

with the primary substance been reviewed? 

Describe, along with any proposed 

limitations. 

X

Category 3. Is the substance compatible with organic handling practices? Substance: Glycerin 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

handling? [§6517(c)(1)(A)(iii); 

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

X TAP says consistent when used with specific 

food products

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible with 

organic handling? [§205.600(b)(2)] 

X Current version on the National List is 

considered a synthetic, therefore it would 

not be compatible with organic handling. 

According to the petitioner, there is now 

sufficient capacity for organically produced 

glycerin to supply the organic market.

3. Is the substance compatible with a system of 

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

4. Are the ancillary substances reviewed 

compatible with organic handling [?

X

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

X One of the uses of glycerin is as a 

preservative but it has many more uses

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values 

lost in processing (except when required by 

law)? [§205.600(b)(4)]

X Glycerin is used as a flavor and/or color 

carrier, and is used to improve textures.

Page 26 of 104
Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially 

unavailable? [§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Substance: Glycerin

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the comparative description as to why the 

non-organic form of the material /substance 

is necessary for use in organic handling

provided? 

X Petition is for removal of synthetic glycerin. 

Petitioner claims there is sufficient quantity 

of organic glycerin available. Per the TR: 

Glycerin can be produced organically by the 

process of microbial fermentation using only 

mechanical and biological processes as 

required in §205.270(a) without the use of 

allowed synthetics listed in §205.605(b). In 

addition, certified organic glycerin can be 

produced by hydrolysis of organic fats and 

oils using either steam splitting or traditional 

saponification with a catalytic amount of an 

alkali (sodium carbonate, sodium hydroxide, 

or potassium hydroxide) on the National List. 

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic handling? 

X See above. Petitioner claims there is 

sufficient organic glycerin available and the 

synthetic version is no longer necessary.

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quality to fulfill an essential 

function in a system of organic handling? 

X See petition at: 

http://www.ams.usda.gov/AMSv1.0/

getfile?dDocName=STELPRDC5101924

4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling?

X When synthetic glycerin was recommended 

for inclusion on the National List, there was 

an insufficient supply or organic glycerin. 

According to the petitioner, that is no longer 

the case.

Per the TR: There are currently 21 USDA 

certified organic operations supplying 

glycerin for organic food or cosmetic 

products. 

5. Does the industry information about 

unavailability include (but is not limited to) 

the following?: 

a. Regions of production (including factors 

such as climate and number of regions);

X

b. Number of suppliers and amount 

produced;

X There are currently 21 USDA certified organic 

operations supplying glycerin for organic 

Page 27 of 104
food or cosmetic products. Specific supplier 

information (TR Table Line: 674)

c. Current and historical supplies related to 

weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; 

X

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

X

e. Other issues which may present a 

challenge to a consistent supply?

X

Page 28 of 104
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Whole Algal Flour

August 20, 2014

Summary of Proposed Action: 

The Handling Subcommittee has reviewed the petition submitted by Solazyme, Inc. seeking permission to 

have Whole Algal Flour added to the National List of Approved Materials under §205.606 – Non-organically 

produced agricultural products allowed as ingredients in or on processed products labeled as “organic” or 

“made with organic (specified ingredients or food group(s)).”

Whole Algal Flour is manufactured from, a microalgae by fermenting and harvesting cultures of a nontoxigenic strain of Chlorella protothecoides. The petitioner noted that algae is also a single-celled organism 

which could possibly place it on §205.605(a) – Non-agricultural (non-organic) substance (non-synthetic). It’s 

primary proposed use would be as a whole food ingredient used as either a partial replacement for food 

ingredients that provide dietary fat and/or protein such as cream, milk, eggs/egg yolks, and/or butter or 

shortening in baked goods, beverages, dairy and egg products, sauces, gravies, margarines, salad dressings 

and soups or as an added ingredient for texture and mouth feel enhancement.

On September 6, 2013 the petition was received by the National Organic Program and forwarded to the 

NOSB’s Handling Sub-committee for petition review and consideration for listing. On January 14, 2014 the 

Handling Sub-committee received from the petitioner a response to several questions that they had 

concerning whole algal flour after the review of the original petition had been completed. Both the original 

petition dated September 6, 2013 and the supplemental dated January 21, 2014 contained a tremendous 

amount of information that was redacted because it was considered to be Confidential Business 

Information (CBI). This afforded the Subcommittee no opportunity to make a determination on the material 

or to complete its responsibility of looking at ancillary substances for the newly petitioned material.

Explanation of Motions: The Handling Subcommittee made the Classification Motion listed below because it 

could not determine whether the material was synthetic or non-synthetic based on the information 

provided. The Subcommittee made the Listing Motion shown below because it felt that they could not 

make a full determination due to the uncertainty created by the redaction of a large amount of Confidential 

Business Information (CBI). The Subcommittee also discussed the essentiality of this substance, since there 

are numerous alternatives available for use that are currently allowed, as stated in the petition. The 

Subcommittee could also not complete its due diligence assessing ancillary substances because of a lack of 

access to the appropriate information.

Evaluation Criteria (see attached checklist) 

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes ☒ No ☐ N/A

3. Compatibility & Consistency ☐ Yes ☒ No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☒ Yes ☐ No ☐ N/A 

as Organic (only for §205.606)

Page 29 of 104
Substance Fails Criteria Category: 2 (see attached checklist)

Subcommittee Action & Vote

Classification Motion: Move to classify Whole Algal Flour as non-synthetic. 

Motion by: Harold Austin 

Seconded by: John Foster 

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

Listing Motion: Move to list Whole Algal Flour on section 205.606 (of the National List): non-organically 

produced agriculture products allowed as ingredients in or on processed products labeled as “organic” 

or “made with organic (specified ingredients or food group(s)).”

Motion by: Harold Austin 

Seconded by: John Foster 

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

 

Approved by Harold Austin, Subcommittee Chair, to transmit to NOSB August 19, 2014

NOSB Evaluation Criteria for Substances Added To the National List 

Category 1. Adverse impacts on humans or the environment? Substance: Whole Algal Flour 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use or 

misuse of the substance? 

[§205.600(b)(2), [§6518(m)(3)]

X

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the substance? 

[§6518(m)(3)]

X

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

Unable to determine due to CBI.

5. Is there undesirable persistence or 

concentration of the material or breakdown 

products in the environment? [§6518(m)(2)]

X

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added to it? 

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

We can’t determine due to inability to 

establish what possible ancillary substances 

there might be in both the main substance 

and ancillary substances alike due to CBI 

Page 30 of 104
§6518(m)(4), 205.600(b)(3)] blackout.

7. Is the substance, and any ancillary 

substances, GRAS when used according to 

FDA’s good manufacturing practices? 

[§205.600(b)(5)] 

Unknown. Page 6 and 7 of the petition for 

Whole algal flour states that on June 7, 2013 

the FDA issued a No Questions letter (GRN 

469) for whole algal flour. The petitioner has 

self-affirmed WAF to be GRAS, page 4 of the 

petition. Because there is so much CBI there 

is no logical way to determine this.

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 (b)(5)]

Unknown

Category 2. Is the Substance Essential for Organic Production? Whole Algal Flour

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X Petitioner claims that it should be classified 

as a microorganism and is nonagricultural. It 

may belong on 205.606 non-organically 

grown agricultural product.

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Made by fermentation process in a closed 

system. Process is CBI.

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

Goes through fermentation and has either 

potassium hydroxide or sodium hydroxide 

added to adjust the ph (both are on the 

national list).

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X Organic milk, cream, eggs/egg yolks are 

currently being used and others.

7. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600(b)(6)]

X There currently are alternatives being used.

8. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

X

9. Are there any alternative substances? 

[§6518(m)(6)] 

X There are substances currently on the 

National List of Approved Substances that 

are being used such as: starch products, 

some of the gums, hydrocolloids, to name 

just a few.

10. Is there another practice (in farming or X

Page 31 of 104
handling) that would make the substance 

unnecessary? [§6518(m)(6)]

11. Have the ancillary substances associated 

with the primary substance been reviewed? 

Describe, along with any proposed 

limitations. 

X Ancillary substances are unknown at this 

time due to the huge amount of CBI within 

the materials petition. A decision on 

limitations can’t be made because there is no 

possible way to determine what the ancillary 

substances in this material are. Also, by the 

petitioners own statement they add different 

things based upon the individual customer’s 

needs.

Category 3. Is the substance compatible with organic handling practices? Whole Algal Flour

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

handling? [§6517(c)(1)(A)(iii); 

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

Unknown

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible with 

organic handling? [§205.600(b)(2)]

X

3. Is the substance compatible with a system of 

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

X

4. Are the ancillary substances reviewed 

compatible with organic handling [? 

We are not able to make that determination 

with the information provided. Petition 

contains too much CBI and the potential list 

of ancillary substances is not able to be 

determined, even with the supplemental 

information provided by the petitioner.

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

We are not able to make that determination 

with the information provided.

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

X

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values 

lost in processing (except when required by 

law)? [§205.600(b)(4)]

X The primary use is to reduce and replace 

substances currently being used to help 

reduce fat content, improve texture and 

mouth feel in some products.

Page 32 of 104
Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially 

unavailable? [§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Whole Algal Flour

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the comparative description as to why the 

non-organic form of the material /substance 

is necessary for use in organic handling

provided? 

X There currently is not an organic form of this 

substance available on the market for use in 

organic handling.

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic handling? 

X

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quality to fulfill an essential 

function in a system of organic handling? 

X

4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling?

X

5. Does the industry information about 

unavailability include (but is not limited to) 

the following?: 

a. Regions of production (including factors 

such as climate and number of regions);

X

b. Number of suppliers and amount 

produced;

X Unknown

c. Current and historical supplies related to 

weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; 

X

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

X

e. Other issues which may present a 

challenge to a consistent supply?

X

Page 33 of 104
Page 34 of 104
Sunset 2015 Review 

Meeting 2 - October, 2014 

Handling Subcommittee Review

Gellan Gum

August 20, 2014

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

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

Gellan Gum Agricultural

Use - As a nonagricultural (nonorganic) substance allowed as ingredient in or on processed products

Listing: Gellan gum (CAS # 71010-52-1) - high acyl form only.

Technical Report: 2006

Petition(s): Gellan gum (2004) 

Past NOSB Actions: NOSB review and recommendation for addition to the National List - 04/22/08

Regulatory Background: 

Proposed for addition to National List 6/3/09 (74 FR 26591) 

Added to National List 12/13/2010 (75 FR 77521) 

Sunset Date: 12/14/2015

Reference: 7 CFR 205.605(a)

Subcommittee Review

Summary:

Gellan gum is a polysaccharide gum produced as a fermentation product of the microbe Sphingomonas elodea. 

This bacterium produces a gum which is useful as a thickening and gelling agent in food products, including 

bakery fillings, confections, dairy products, dessert gels, frostings, icings, glazes, jams, etc. 

Gellan gum was petitioned for addition to 205.605(b) in 2004. In 2006, a technical evaluation report was 

completely for the Handling Committee. The committee recommended the addition to 205.205(b) in April, 

2007. However, detailed discussion among the board, the NOP and the petitioner at that meeting led to the 

conclusion that gellan gum is in fact non-synthetic, and accordingly should be added to 205.605(a). The 

Handling Committee made an updated recommendation in December 2007, and it was passed by the full NOSB 

at the April, 2008 meeting. 

The 2007 and 2008 discussions weighed heavily the question of whether gellan gum provided sufficiently 

unique properties other than those afforded by gums already listed on 205.606. Based on the petition, the 

2006 TAP review, and testimony from the petitioner and other stakeholder, the board concluded that gellan 

gum was in fact essential: 

The Board considered what constitutes “essential” for organic handling of a finished retail product and how 

that may be different from that of a material used in crop or livestock production. It was agreed that certain 

materials might be essential for creating a product that meets consumer expectations of taste or texture. A 

Page 35 of 104
number of commenters cited gellan gum would greatly enhance the organic consumer products they make for 

this reason. One commenter stated that gellan gum has unique functionality that is not offered by similarly 

produced gums that are currently allowed in organic handling. There were no public comments specifically 

opposing the listing of gellan gum on 205.605.

An extensive search of relevant medical and food science literature since 2007 shows no significant new data or 

findings that would impact the evaluation of this substance. We were unable to locate any relevant regulatory 

changes related to this ingredient among the world’s regulatory bodies.

The current listing is for: Gellan Gum – high acyl only

This is significant because low acyl gellan gum has been determined to be synthetic; only high acyl is nonsynthetic and should be listed on 605(a). 

At the Spring 2014 NOSB meeting, two commenters noted that low-acyl gellan gum should be on 605(b), not 

(a). We wish to clarify that low acyl gellan gum is synthetic and isn’t being considered in this recommendation. 

The existing listing and the sunset proposal is only for the high acyl gellan gum, which is non-synthetic. 

Numerous other commenters confirmed that the material remains essential in the production of non-dairy 

beverages and other foods. 

The 2007 and 2008 discussions also focused on the role of the isopropyl alcohol used to separate the finished 

gellan gum from the fermentation materials. According to the 2006 TR, the FDA limits the amount of isopropyl 

alcohol in the finished gellan gum to .075 %. Regardless, the presence of the isopropyl alcohol was 

acknowledged in the petition, TR and recommendation and factored into the evaluation of the material. 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

Based on the Subcommittee’s review, the Subcommittee proposes removal of this substance from the National 

List based on the following criteria in the Organic Foods Production Act (OFPA) 7 U.S.C. 6158(m)(6) the 

alternatives to using the substance in terms of practices or other available materials; (7) its compatibility with a 

system of sustainable agriculture.

Subcommittee Review

The Handling Subcommittee believes that the full Board should have the opportunity to complete the review 

of each sunset material by voting. The NOP has stated that to do this a motion to remove should be brought 

from the Subcommittee for each substance. If the Subcommittee motion to remove fails to receive a 

majority, the motion will still be put forward to the full board for review. The motion to remove is voted by 

the full Board and needs to receive a 2/3 majority to recommend removal.

Motion to Remove Gellan gum from §205.605(a) 

Motion by: Joe Dickson

Seconded: John Foster 

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

Page 36 of 104
Sunset 2015 Review 

Meeting 2 - October 2014 

Handling Subcommittee Review

Tragacanth

August 22, 2014

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

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

Tragacanth Gum Agricultural

Use – As nonorganically produced agricultural product allowed as ingredient in or on processed products.

Listing: Tragacanth gum (CAS #-9000-65-1).

Technical Report: none

Original Petition: Tragacanth Gum (PDF) (2007)

Past NOSB Actions: NOSB review and recommendation for addition to the National List 5/08

Regulatory Background: 

Proposed for addition to National List 6/3/09 (74 FR 26591) 

Added to National List 12/13/2010 (75 FR 77521) 

Sunset Date: 12/14/2015

Reference: 7 CFR 205.606(x)

Subcommittee Review

This substance was originally reviewed by the handling committee and added to 205.606 by the NOSB in 

May, 2008. The committee noted at the time that due to limited growing regions (Turkey and Iran) and 

relevant trade embargoes, the supply of conventional tragacanth gum was fragile and limited, and organic 

tragacanth gum was not known to be in production. The Board Summary from the 2008 recommendation is 

reprinted here:

Tragacanth gum, water-extracted is an exudite gum and is harvested and processed in a manner 

which is identical to other exudite gums already included on §205.606 of the National List. The 

Board considered whether it is necessary to add another gum to the National List and was 

persuaded that although Tragacanth gum is derived by an identical process to gum Arabic, it has 

sufficiently different functionality to justify its inclusion on the National List. 

The Board also considered the reasons for this material being commercially unavailable in an 

organic form and the prospects for such availability in the future. At present this tree is primarily 

cultivated in Iran and the current embargo which exists on U.S. trade with this country had 

disrupted the supply of even the conventional form of this material. Turkey has increased its 

production of conventional Tragacanth gum and also is expanding its organic production. The 

petitioner is working closely with their Turkish supplier and believes that a supply of this material in 

an organic will be made available in the next several years. The Board feels that this material meets 

evaluation criteria in all four categories required for listing on section 205.606 of the National List.

Commercial Availability

While the petition and 2008 recommendation note that Turkey is expanding organic production of 

Page 37 of 104
tragacanth gum, a thorough search of internet sources and ingredient supply catalogs provided no 

suggestion that the ingredient is available in organic form. This aspect is specifically highlighted here in 

order to elicit comments from any suppliers or other stakeholders who are aware of organic sources of the 

ingredient. At the Spring 2014 meeting, the NOSB only heard from one certifier verifying that this material 

is in current use in non-organic form. We invite any other users of this substance to verify its necessity 

through written or oral comment. 

Safety and Regulatory Acceptability

A search of the medical literature shows no new safety or other medical data related tragacanth gum since 

the original petition and review process. We were unable to locate any relevant regulatory changes related 

to this ingredient among the world’s regulatory bodies. 

In summary, this may be a material with few current users and with possibly functional organic alternatives 

available. If there are users of this material out there with compelling arguments as to its necessity, we 

encourage them to comment on this material for the fall meeting. 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

Based on the Subcommittee’s review, the Subcommittee proposes removal of this substance from the 

National List based on the following criteria in the Organic Foods Production Act (OFPA) 7 U.S.C. 6158(m)(6) 

the alternatives to using the substance in terms of practices or other available materials; (7) its 

compatibility with a system of sustainable agriculture.

Subcommittee Review

The Handling Subcommittee believes that the full Board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should 

be brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to 

receive a majority, the motion will still be put forward to the full board for review. The motion to remove 

is voted by the full Board and needs to receive a 2/3 majority to recommend removal.

Motion to remove Tragacanth Gum from §205.606(x) 

Motion by: Joe Dickson

Seconded by: Harold Austin

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

Page 38 of 104
Sunset 2015 Review 

Meeting 2 - October 2014 

Handling Subcommittee Review

Marsala 

August 22, 2014

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

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

Marsala Agricultural

Use – As nonorganically produced agricultural product allowed as ingredient in or on processed products

Listing: Fortified cooking wines. (1) Marsala 

Technical Report: none

Petition(s): Marsala, (2007)

Past NOSB Actions: NOSB review and recommendation for addition to the National List 11/30/07 

Regulatory Background: 

Proposed for addition to National List 6/3/09 (74 FR 26591) 

Added to National List 12/13/2010 (75 FR 7751) 

Sunset Date: 12/14/2015

Reference: 7 CFR 205.606(g)(1)

Subcommittee Review

Summary:

This is the second posting for the Sunset 2015 review for Fortified Cooking Wine – Marsala, which was added 

to the National list in 2010; please refer to the questions answered in Category 4. 

Marsala was originally petitioned in 2007 for addition to 205.606 because it was considered a unique flavor 

ingredient that was not commercially available as organic. At present, there appears to be very few if any

organic entrees utilizing Marsala as an ingredient. This could be an indication of low consumer product 

demand. The Handling Subcommittee proposes to remove Marsala from 205.606, and we request that the 

public provide comment regarding the following: the commercial demand for both conventional and organic

Marsala, and the impact that the removal of Marsala from 205.606 would have on your business. During the 

first comment period, in spring 2014, the original petitioner, did not comment and the Subcommittee could 

not find current contact information for them. 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

Based on the Subcommittee’s review, the Subcommittee proposes removal of this substance from the 

National List based on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 

205.600(b) if applicable: 205.600(b)(6) the substance is essential for the handling of organically produced 

agricultural products.

In an informal 2013 survey of a handful of stores and certifiers, no products containing Marsala were 

Page 39 of 104
encountered. It appears that there is limited to zero use of Marsala in organic entrees in the US; this might be 

an indication of low demand or little interest in Marsala as an ingredient in organic entrees. Additionally, no 

organic or conventional Marsala was found to be available on any of the 30 websites listed on the original 

2007 Sherry Petition Organic Fortified Cooking Wine Source List. With low demand, the limited availability of 

organic Marsala in the U.S. may not be an issue. Without input from the original petitioner, it’s difficult to 

assess the impact of a decision to de-list Marsala.

The Handling Subcommittee believes that the full board should have the opportunity to complete the review 

of each sunset material by voting. The NOP has stated that to do this a motion to remove should be brought 

from the subcommittee for each substance. If the Subcommittee motion to remove fails to receive a majority, 

the motion will still be put forward to the full board for review. The motion to remove is voted by the full 

board and needs to receive a 2/3 majority to recommend removal.

Motion: Remove Marsala from the National List at 205.606(g)(1) 

Motion by: Tracy Favre 

Seconded by: Zea Sonnabend

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

NOSB Evaluation Criteria for Substances Added To the National List (Optional Checklist) 

Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially unavailable? 

[§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Substance: Marsala cooking wine 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the comparative description as to why the 

non-organic form of the material /substance 

is necessary for use in organic handling

provided? 

x 2007 original Petition (pg.1-2)-Marsala is a 

key flavor ingredient in organic entrees. In 

2007, there were no sources of organic 

fortified cooking wine available in the 

quantity and form necessary for their 

products.

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic handling? 

x In an informal 2013 survey of a handful of 

stores and certifiers, no products containing 

marsala were encountered. It appears that 

there is limited to zero use of marsala in 

organic entrees in the US; this might be an 

indication of low demand or little interest in 

marsala as an ingredient in organic entrees.

Additionally, no organic or conventional 

marsala was found to be available on any of 

the 30 websites listed on the original 2007 

Sherry Petition Organic Fortified Cooking 

Wine Source List.

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

x See question # 2. 

Page 40 of 104
cannot be obtained organically in the 

appropriate quality to fulfill an essential 

function in a system of organic handling? 

4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling?

x See question # 2.

5. Does the industry information about 

unavailability include (but is not limited to) 

the following?: 

a. Regions of production (including factors 

such as climate and number of regions);

x

b. Number of suppliers and amount 

produced;

x

c. Current and historical supplies related to 

weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; 

x

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

x

e. Other issues which may present a 

challenge to a consistent supply?

x If there is no demand for marsala, there will 

be no incentive to produce organic marsala.

Page 41 of 104
Page 42 of 104
Sunset 2015 Review 

Meeting 2 - October 2014 

Handling Subcommittee Review

Sherry

August 22, 2014

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

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

Sherry Agricultural

Use - As nonorganically produced agricultural product allowed as ingredient in or on processed products

Listing: Fortified cooking wines. (2) Sherry

Technical Report: none

Original Petition: Sherry (2007)

Past NOSB Actions: NOSB review and recommendation for addition to the National List 05/08

Regulatory Background: 

Proposed for addition to National List 6/3/09 (74 FR 26591) 

Added to National List 12/13/2010 (75 FR 7751) 

Sunset Date: 12/14/2015

Reference: 7 CFR 205.606(g)(2)

Subcommittee Review

Summary:

The original petition cited the flavor profile of cooking Sherry as being unique, and that no organic sources of 

were available. Cooking Sherry, or Sherry of any kind, is made using standard wine making processes, and is 

fortified with Brandy, which acts as a preservative and therefore no added sulfites are necessary. There are 

small-scale organic sources of Brandy available in the U.S., although the quantities available are not certain. 

Additionally, there are international sources of organic Brandy. The key to the manufacture of Sherry is Flor 

yeast, which is available from Spain. Generally, there is low demand for Sherry in the United States, with 

Americans preferring other forms of wine. The United Kingdom and other European countries have higher 

demand for Sherry. 

After discussions with various industry personnel, there seems to be no barrier to manufacture of organic 

Cooking Sherry, but there is very low demand for it. The original petitioner of the material did not comment 

during the first comment period in Spring 2014, and contact information was unavailable. One U.S. producer 

of organic wines did indicate that he has been contacted 2-3 times in the last few years to see if he produced 

the product, but the requester indicated that his price was too high.

With low demand, the limited availability of organic Sherry in the U.S. may not be an issue. Without input 

from the original petitioner, it’s difficult to assess the impact of a decision to de-list Cooking Sherry.

The Handling Subcommittee requests public feedback regarding the impact that removal of Sherry would have 

on your operation. 

Page 43 of 104
Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

Based on the Subcommittee’s review, the Subcommittee proposes removal of this substance from the 

National List based on the following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 

205.600(b) if applicable: 205.600(b)(6) the substance is essential for the handling of organically produced 

agricultural products.

The Handling Subcommittee believes that the full board should have the opportunity to complete the 

review of each sunset material by voting. The NOP has stated that to do this a motion to remove should be 

brought from the Subcommittee for each substance. If the Subcommittee motion to remove fails to receive 

a majority, the motion will still be put forward to the full board for review. The motion to remove is voted 

by the full board and needs to receive a 2/3 majority to recommend removal.

Motion: Remove Sherry from the National List at 205.606(g)(2) 

Motion by: Tracy Favre 

Seconded by: Zea Sonnabend

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

NOSB Evaluation Criteria for Sunset Review (Optional checklist)

Category 1. Adverse impacts on humans or the environment? Fortified Cooking Wine - Sherry

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use or 

misuse of the substance?

[§205.600(b)(2), [§6518(m)(3)]

X

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the substance? 

[§6518(m)(3)]

X

3. Are there any adverse impacts on

biodiversity? (§205.200)

X

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X

5. Is there undesirable persistence or 

concentration of the material or breakdown 

products in the environment? [§6518(m)(2)]

X

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added to it? 

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

X Over consumption of alcoholic beverages 

does have harmful effects on human health, 

but cooking sherry is not typically over 

consumed. 

Page 44 of 104
§6518(m)(4), 205.600(b)(3)] 

7. Is the substance, and any ancillary 

substances, GRAS when used according to 

FDA’s good manufacturing practices? 

[§205.600(b)(5)]

X

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 (b)(5)]

X

Category 2. Is the Substance Essential for Organic Production? Substance: Fortified Cooking Wine - Sherry

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X Made from wine grapes and fortified with 

brandy, both agricultural products.

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Natural fermentation process and distillation.

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

X Natural fermentation process creates alcohol 

in the grape juice.

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X Natural fermentation, with the inclusion of 

Flor yeast creates the unique flavor profile.

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X Low demand but there are small scale 

producers in the U.S.

7. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600(b)(6)]

X According to the petitioner, the flavor profile 

of Cooking Sherry imparts a unique flavor to 

the final product but it is not absolutely 

essential for use.

8. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

X

9. Are there any alternative substances? 

[§6518(m)(6)]

X X Other fortified wines could be used but 

would not have the same flavor profile

10. Is there another practice (in farming or 

handling) that would make the substance 

unnecessary? [§6518(m)(6)]

X

11. Have the ancillary substances associated 

with the primary substance been reviewed? 

Describe, along with any proposed 

limitations. 

X

Page 45 of 104
Category 3. Is the substance compatible with organic handling practices? Substance: Fortified Cooking Wine - 

Sherry 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

handling? [§6517(c)(1)(A)(iii); 

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

X Cooking Sherry as currently on the National 

List is not organic.

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible with 

organic handling? [§205.600(b)(2)]

X See above comment

3. Is the substance compatible with a system of 

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

X See above comment

4. Are the ancillary substances reviewed 

compatible with organic handling [?

X No ancillary substances

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X Flavor profile only.

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

X Because of the brandy in fortified wine, it has 

natural preservative properties but that is 

not the primary use in products.

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive values 

lost in processing (except when required by 

law)? [§205.600(b)(4)]

X Primary use is to impart a specific flavor 

profile to foods.

Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially unavailable? 

[§6610, 6518, 6519, §205.2, § 205.105(d), §205.600(c)] Substance: Fortified Cooking Wine - Sherry 

Question Yes No N/A Comments/Documentation. (TAP; petition; 

regulatory agency; other)

1. Is the comparative description as to why the 

non-organic form of the material /substance 

is necessary for use in organic handling 

provided? 

X Original petition cited the flavor profile of 

cooking Sherry as being unique to the 

product, and no organic sources of the 

material was available. 

2. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate form to fulfill an essential 

function in a system of organic handling? 

X Conversations with various industry 

personnel indicate that there is low demand 

for sherry in the U.S. except as a cooking 

wine, therefore there has been no significant 

incentive for development of an organic 

source. However, there are no real obstacles 

to producing an organic version, based upon 

materials and/or processes. 

3. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quality to fulfill an essential 

function in a system of organic handling? 

X There seems to be no barrier to production 

except for limited demand.

Page 46 of 104
4. Does the current and historical industry 

information, research, or evidence provided 

explain how or why the material /substance 

cannot be obtained organically in the 

appropriate quantity to fulfill an essential 

function in a system of organic handling?

X X Initial investigation has indicated that smallscale producers would be able to provide the 

ingredient, but information regarding the 

amount required as an ingredient for the 

products mentioned in the petition is not 

available. There was no information 

available regarding foreign sources for the 

material.

5. Does the industry information about 

unavailability include (but is not limited to) 

the following?:

a. Regions of production (including factors 

such as climate and number of regions);

X A small-scale producer is available in the 

Pacific Northwest, however there is 

insufficient information regarding the 

national demand for the product so it’s not 

clear whether the location of the 

manufacture of the material is relevant.

b. Number of suppliers and amount 

produced;

X Investigation has only shown one small- scale 

U.S. producer on an as-needed basis but the 

total amount produced is not available.

c. Current and historical supplies related to 

weather events such as hurricanes, 

floods, and droughts that may 

temporarily halt production or destroy 

crops or supplies; 

X See comment above.

d. Trade-related issues such as evidence of 

hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

X See comment above.

e. Other issues which may present a 

challenge to a consistent supply?

X Limited production due to limited demand 

could cause restrictions in availability should 

demand increase.

Page 47 of 104

National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset 2016 Review Summary 

Meeting 1: October 2014

Request for Public Comment

Handling Substances 

September 2014

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 which must be reviewed by the NOSB and renewed by the USDA

before their sunset dates in 2016. This list provides the substance’s current status on the National List, 

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

applicable. 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

While the NOSB will not complete its review and any recommendations on these substances until spring 

2015 public meeting, the NOP is requesting that the public provide comments about these substances to 

the NOSB as part of the fall 2014 public meeting. These comments should be provided 

through www.regulations.gov by October 7, 2014 as explained in the meeting notice published in 

the Federal Register on September 8, 2014.

These comments are necessary to guide the NOSB’s review of each substance against the criteria in the 

Organic Foods Production Act (7 U.S.C. 6518(m)) and the USDA organic regulations (7 CFR 205.600). The 

current substances on the National List were originally recommended by the NOSB based on evidence 

available to the NOSB at the time of their last review which demonstrated that the substances were 

found to be: (1) not harmful to human health or the environment, (2) necessary because of the 

unavailability of wholly nonsynthetic alternatives, and (3) consistent and compatible with organic 

practices. 

Public comments should focus on providing new information about a substance since its last NOSB 

review. Such information could include research or data that may support a change in the NOSB’s 

determination for a substance. Public comment should also address the continuing need for a substance 

or whether the substance is no longer needed or in demand.

Guidance on Submitting Your Comments

Comments should clearly indicate your position on the allowance or prohibition of substances on the list 

and explain the reasons for your position. You should include relevant information and data to support 

your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.). 

For Comments That Support Substances Under Review:

If you provide comments in support of an allowance of a substance on the National List, you should 

provide information demonstrating that the substance is: 

(1) not harmful to human health or the environment;

 Page 48 of 104 
(2) necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

(3) consistent with organic handling. 

For Comments That Do Not Support Substances Under Review: 

If you provide comments that do not support a substance on the National List, you should provide 

reasons why the use of the substance should no longer be allowed in organic production or handling. 

Specifically, comments that support the removal of a substance from the National List should 

provide new information since its last NOSB review to demonstrate that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with handling. 

For Comments Addressing the Availability of Alternatives: 

Comments may present information about the viability of alternatives for a substance under sunset 

review. Viable alternatives include, but are not limited to:

o Alternative management practices that would eliminate the need for the specific 

substance; 

o Other currently exempted substances that are on the National List, which could 

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

Your comments should address whether any alternatives have a function and effect equivalent to or 

better than the allowed substance, and whether you want the substance to be allowed or removed from 

the National List. Assertions about alternative substances, except for those alternatives that already 

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. The following table can help you describe recommended 

alternatives in place of a current substance that you do not want to be continued.

For Comments on Nonorganic Agricultural Substances at Section 205.606. 

For nonorganic agricultural substances on section 205.606, the NOSB Handling Subcommittee requests 

current industry information regarding availability of and history of unavailability of an organic form of 

the substance in the appropriate form, quality, or quantity of the substance. The NOSB Handling 

Subcommittee would like to know if there is a change in supply of organic forms of the substance or 

demand for the substance (i.e. is an allowance for the nonorganic form still needed), as well as any new 

information about alternative substances that the NOSB did not previously consider. 

Written public comments will be accepted through October 7, 2014 via www.regulations.gov. 

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

 Page 48b of 104
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset 2016 Review Summary 

Meeting 1 - Request for Public Comment

Handling Substances

August 27, 2014 

SUNSET 2016: HANDLING SUBSTANCES

Egg white lysozyme Nonsynthetic 

Use - As a nonsynthetic, nonagricultural (nonorganic) substance allowed as an ingredient in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Egg white lysozyme (CAS # 9001–63–2)

Technical Report: 2011 TR: Enzymes, 2003 TAP: Enzymes, Plant and Fungal

Petition(s): Egg white lysozyme 06/05/02

Past NOSB Actions: NOSB review and recommendation for addition to the National List 05/2003

Recommendation to relist 11/05/2009 

Regulatory Background: Added to National List 09/11/06, 71 FR 53299 

Renewed 08/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(a)

Additional information requested by NOSB

No additional information is requested

L-Malic acid Nonsynthetic 

Use - As a nonsynthetic, nonagricultural (nonorganic) substance allowed as an ingredient in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: L-Malic acid (CAS # 97-67-6)

Technical Report: Malic Acid April 2003. New TR requested in 2014

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

Past NOSB Actions: NOSB review and recommendation for addition to the National List 05/2003

Recommendation to relist 11/05/2009 

Regulatory Background: 

Added to National List 09/11/06 71 FR 53299

Renewed 08/03/2011 76 FR 46595

Sunset Date: 9/12/16

Reference: 7 CFR 205.605(a)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding the essentiality of this substance. We 

encourage current users of this substance to provide detailed comments describing the situations in 

which l-malic acid is the only appropriate substance for a given technical application. 

rev: June 2014

Page 49 of 104
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Microorganisms Nonsynthetic 

Use - As a nonsynthetic, nonagricultural (nonorganic) substance allowed as an ingredient in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Microorganisms - any food grade bacteria, fungi, and other microorganism.

Technical Report: 2014 TR, 2003 TAP

Petition(s): Microorganisms 12/10/02

Past NOSB Actions: NOSB review and recommendation for addition to the National List 05/2003 

Recommendation to relist 11/05/09

Regulatory Background: 

Added to National List with annotation 09/11/06 71 FR 53299

Renewed 08/03/2011 76 FR 46595

Sunset Date 9/12/2016

Reference: 7 CFR 205.605(a)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding the following: 

Microorganisms will be first major review of ancillary substances used with the listed substance and the 

HS is trying to follow the Ancillary Substance Policy adopted by the Board in 2013. 

The chart below lists all the ancillary substances by functional class that were identified in the Technical 

Report as well as those that have been turned in by Accredited Certifiers to make sure they are 

reviewed. The HS seeks additional public input on any other ancillary substances that may be in use in 

microorganism products that go into organic food.

Comment is also welcome in favor or against any particular ancillary substances with specific attention 

paid to alternative choices.

Ancillary Substances by Food Additive Functional Class1

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

Carriers and fillers, agricultural or 

nonsynthetic

lactose, maltodextrins, sucrose, dextrose, potato starch, nonGMO soy oil, rice protein, grain (rice, wheat, corn, barley) 

flour, milk, autolyzed yeast, inulin

Carriers and fillers, synthetic micro-crystalline cellulose, propylene glycol, stearic acid

Preservatives sodium benzoate, potassium sorbate

Stabilizers maltodextrin

1 this list does not include ancillary substances that are already on the National List. From the 2014 Technical 

Report and spec sheets.

rev: June 2014

 

Page 50 of 104
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Cyroprotectants used to freeze-dry 

microorganisms

liquid nitrogen, maltodextrin, magnesium sulfate, dimethyl 

sulfoxide, sodium aspartate, mannitol, sorbitol 

Substrate that may remain in final 

product

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

and sugar, soy

 

Activated charcoal Synthetic 

Use - As a synthetic nonagricultural (nonorganic) substance allowed as an ingredient in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Activated charcoal (CAS #s 7440 - 44 - 0; 64365 - 11 - 3) - only from vegetative sources; for use 

only as a filtering aid. 

Technical Report: Activated Carbon 8/14/02

Petition(s): Charcoal/Activated Carbon 5/20/02 

Past NOSB Actions: NOSB review and recommendation for addition to the National List 9/2002

Recommendation to relist 11/05/09

Regulatory Background: 

Added to National List with annotation 9/11/06 71 FR 53299

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding: 

1. Is this substance still used as a filtering aid by organic handlers as part of their organic 

production process? Could either the handlers themselves or certifiers please confirm that this 

is still being used and thus there still exists a need for its continued listing?

2. Have the stakeholders that have relied upon this substance as part of their handling production 

process looked at other practices or alternatives as a possible replacement? If so could you give 

us examples of what other alternatives you have looked at and are they suitable replacements 

for activated charcoal?

3. Has the use of this substance increased or declined during the current sunset cycle? (This 

question would apply to Handlers- for your specific operation and for certifiers – for those 

operations that you certify and inspect on an annual basis).

4. Have the sources changed for where activated charcoal comes from, that might impact the need 

to continue its listing on the National List or not? (natural source versus synthetic source).

rev: June 2014

Page 51 of 104
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Peracetic acid Synthetic 

Use – As a synthetic nonagricultural (nonorganic) substance allowed as an ingredient in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Peracetic acid/Peroxyacetic acid (CAS # 79 -21- 0). For use as a sanitizer on food contact 

surfaces.

Technical Report: 11/3/2000 TAP (for processing)

Petition(s): none

Past NOSB Actions: NOSB review and recommendation for addition to the National List 11/15/2000

Recommendation to relist at 205.605(b) 11/5/09 

Regulatory Background: 

Added to National List with annotation 9/11/06 71 FR 53299

Renewed: 8/03/2011 76 FR 46595 

Sunset Date: 9/12/16

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

No additional information is requested

Cyclohexylamine Synthetic 

Use – As a synthetic nonagricultural (nonorganic) substance allowed as an ingredient in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Cyclohexylamine (CAS # 108 - 91 - 8) for use only as a boiler water additive for packaging 

sterilization. 

Technical Report: 02/2001

Petition(s): Cyclohexylamine 11/29/2000

Past NOSB Actions: NOSB review and recommendation for addition to the National List 10/2001

Recommendation to relist: 11/5/09

Regulatory Background: 

Added to National List: 09/11/06 71 FR 53299

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding: 

1. How common is the use of this material in organic handling operations?

2. Are there alternative practices or materials that would make the use of this material obsolete?

3. Could ammonium hydroxide, if it were approved for use, serve as a possible substitute for this 

material? 

4. Have there been any changes (increase or decline) in the use of this substance during the 

current sunset cycle?

rev: June 2014

Page 52 of 104
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Diethylaminoethanol Synthetic 

Use – As a synthetic nonagricultural (nonorganic) substance allowed as an ingredient in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Diethylaminoethanol (CAS # 100 -37- 8) for use only as a boiler water additive for packaging

sterilization. 

Technical Report: 2/2001 TAP

Petition(s): Diethylaminoethanol 11/29/00

Past NOSB Actions: NOSB review and recommendation for addition to the National List 5/2002

Recommendation to relist: 11/5/09

Regulatory Background:

Added to National List 09/11/06 71 FR 53299

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding: 

1. How common is the use of this material in organic handling operations?

2. Are there alternative practices or materials that would make the use of this material obsolete?

3. Could ammonium hydroxide, if it were approved for use, serve as a possible substitute for this 

material? 

4. Have there been any changes (increase or decline) in the use of this substance during the 

current sunset cycle?

Octadecylamine Synthetic 

Use – As a synthetic nonagricultural (nonorganic) substance allowed as an ingredient in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)).

Listing: Octadecylamine (CAS # 124–30–1) for use only as a boiler water additive for packaging

sterilization. 

Technical Report: 2/2001 TAP

Petition(s): Octadecylamine 11/29/00

Past NOSB Actions: NOSB review and recommendation for addition to the National List 10/2001

Recommendation to renew: 11/5/09

Regulatory Background: 

Added to National List: 09/11/06 71 FR 53299

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/11/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding: 

rev: June 2014

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National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

1. How common is the use of this material in organic handling operations?

2. Are there alternative practices or materials that would make the use of this material obsolete?

3. Could ammonium hydroxide, if it were approved for use, serve as a possible substitute for this 

material? 

4. Have there been any changes (increase or decline) in the use of this substance during the 

current sunset cycle?

Sodium acid 

pyrophosphate

Synthetic 

Use – As a synthetic nonagricultural (nonorganic) substance allowed as an ingredient in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)). 

Listing: Sodium acid pyrophosphate (CAS # 7758-16-9)

Technical Report: 9/2001 TAP (report is for Sodium Phosphates as a group).

Petition(s): Sodium acid pyrophosphate 10/31/02 

Past NOSB Actions: NOSB review and recommendation for addition to the National List 5/13/2003

Recommendation to relist 11/5/09 

Regulatory Background: 

Added to National List 09/12/06 71 FR 53299 

Renewed 8/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding the essentiality of this substance. We 

encourage current users of this substance to provide detailed comments describing the situations in 

which sodium acid pyrophosphate is the only appropriate leavening agent for a given technical 

application. 

Tetrasodium 

pyrophosphate (TSPP)

Synthetic 

Use – As a synthetic nonagricultural (nonorganic) substance allowed as an ingredient in or on processed 

products labeled as “organic” or “made with organic (specified ingredients or food group(s)). 

Listing: Tetrasodium pyrophosphate (CAS # 7722–88–5) - for use only in meat analog products.

Technical Report: 2014 Limited Scope TR, 2002 TAP 

Petition(s): TSPP 12/10/2001

Past NOSB Actions: NOSB review and recommendation for addition to the National List 9/17/2002

Sunset Recommendation to relist: 11/5/09

Regulatory Background: 

Added to National List 09/12/06 71 FR 53299

rev: June 2014

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National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Renewed 8/03/2011 76 FR 46595 

Sunset Date: 9/12/2016

Reference: 7 CFR 205.605(b)

Additional information requested by NOSB 

The Handling subcommittee is interested in comments regarding the following: 

The 2014 Technical Report elaborated on many alternatives to the use of this substance, both 

alternative vegetarian protein sources and alternative ways of processing this protein. The 

subcommittee would like public comment that is very specific about situations in which using TSPP 

would be the only viable choice and the reasons why.

The subcommittee has also raised the concern about the sole function of this input being to restore 

texture after complex processing and this runs counter to §205.600(4): "The substance's primary use is 

not as a preservative or to recreate or improve flavors, colors, textures, or nutritive value lost during 

processing, except where the replacement of nutrients is required by law". Input is sought on this 

subject.

Preliminary discussion among the Handling subcommittee is leading towards an inclination to remove 

this substance because of the concerns mentioned above.

rev: June 2014

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National Organic Standards Board

COMPLIANCE, ACCREDITATION, AND CERTIFICATION SUBCOMMITTEE

Assessing Soil Conservation Practices Discussion Document

August 27, 2014

I. INTRODUCTION:

The Organic Foods Production Act of 1990 (OFPA) and the National Organic Program (NOP) 

standards emphasize the importance of maintaining and improving soil quality in numerous places. 

Over the years of National Organic Standards Board (NOSB) deliberations and public discourse, we 

find a clear and consistent commitment to these tenets; in fact, keeping soil in good tilth is both a 

founding principle and expectation of the entire organic community. Because soil conservation is 

critical to maintaining soil health, and soil health is critical to the future of farming, the NOP has 

tasked the NOSB Certification, Accreditation, and Compliance Subcommittee (CACS) with generating 

a discussion document to assess the state of soil conservation practices on organic farm and 

livestock operations. It is our intention to bring soil conservation per se permanently and 

deliberately into the public discourse when we talk about soil management and the practices 

employed on organic farms. 

With the help of the certification community and public, we hope to provide clarity about which 

aspects of soil conservation found within the regulation are working well and which need further 

attention or warrant guidance as to their implementation. This assessment of practices will then be 

used to develop specific training and tools to further soil conservation objectives.

II. BACKGROUND:

The NOP is aware of concerns regarding use of appropriate soil conservation practices on organic 

farms, for instance prevention of soil erosion, tillage, fencing of livestock from streams, application 

of manure on frozen soil, and overgrazing of pasture. The Board would like to determine if and how 

grower and livestock operations are complying with the portions of the regulation stating that 

operators must maintain or improve the natural resources, including soil and water quality. Since 

the Natural Resources Conservation Services (NRCS) has been critical to improving our soil resources 

for decades, CACS looked to the NRCS for technical expertise and to assist in aligning as closely as 

possible organic practices and regulatory guidance with their longstanding valuable work toward a 

sustainable soil culture.

The following paragraph is taken from the NRCS webpage. 

“The NRCS mission is to improve the health of our Nation’s natural resources while sustaining and 

enhancing the productivity of American agriculture. The NRCS achieves this by providing voluntary 

assistance through strong partnerships with private landowners, managers, and communities to 

protect, restore, and enhance the lands and waters upon which people and the environment 

depend. The NRCS Vision is to create productive working lands in harmony with a healthy 

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environment. Their conservation process entails the following three steps, including 1) resource 

inventory and assessment; 2) technical assistance and technology transfer; and 3) conservation and 

implementation. The 2011 – 2015 NRCS Strategic Plan has three priorities including: 1) getting more 

conservation on the ground; 2) increasing organizational effectiveness and efficiency; and 3) 

creating a climate where private lands conservation will thrive.” 

The intersection between NOP and NRCS goals is evident and the opportunity to share best 

practices is welcomed.

III. RELEVANT AREAS IN THE RULE:

205.2 Terms Defined:

Crop rotation. The practice of alternating the annual crops grown on a specific field in a planned 

pattern or sequence in successive crop years so that crops of the same species or family are not 

grown repeatedly without interruption on the same field. Perennial cropping systems employ means 

such as alley cropping, intercropping, and hedgerows to introduce biological diversity in lieu of crop 

rotation.

Natural resources of the operation. The physical, hydrological, and biological features of a 

production operation, including soil, water, wetlands, woodlands, and wildlife.

Organic production. A production system that is managed in accordance with the Act and 

regulations in this part to respond to site-specific conditions by integrating cultural, biological, and 

mechanical practices that foster cycling of resources, promote ecological balance, and conserve 

biodiversity. 

Pasture. Land used for livestock grazing that is managed to provide feed value and maintain or 

improve soil, water, and vegetative resources.

Soil and water quality. Observable indicators of the physical, chemical, or biological condition of soil 

and water, including the presence of environmental contaminants.

205.200 General

The producer or handler of a production or handling operation intending to sell, label, or represent 

agricultural products as “100 percent organic,” “organic,” or “made with organic (specified 

ingredients or food group(s))” must comply with the applicable provisions of this subpart. 

Production practices implemented in accordance with this subpart must maintain or improve the 

natural resources of the operation, including soil and water quality. 

205.203(a) The producer must select and implement tillage and cultivation practices that maintain 

or improve the physical, chemical, and biological condition of soil and minimize soil erosion.

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205.203(b) The producer must manage crop nutrients and soil fertility through rotations, cover 

crops, and the application of plant and animal materials.

205.203(c) The producer must manage plant and animal materials to maintain or improve soil 

organic matter content in a manner that does not contribute to contamination of crops, soil, or 

water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances. 

205.203(d) A producer may manage crop nutrients and soil fertility to maintain or improve soil 

organic matter content in a manner that does not contribute to contamination of crops, soil, or 

water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances 

by applying: (see numbers 1 – 5).

205.205(d) The producer must implement a crop rotation including but not limited to sod, cover 

crops, green manure crops, and catch crops that provide the following functions that are applicable 

to the operation: (see letters a – d).

205.240(c) A pasture plan must be included in the producer's organic system plan, and be updated 

annually in accordance with §205.406(a). The producer may resubmit the previous year's pasture 

plan when no change has occurred in the plan. The pasture plan may consist of a pasture/rangeland 

plan developed in cooperation with a Federal, State, or local conservation office: Provided, that, the 

submitted plan addresses all of the requirements of §205.240(c)(1) through (8).

IV. DISCUSSION:

As mentioned above, maintaining and improving soil quality is a founding principle of organic 

production whose roots are deep within the non-governmental standards across the country long 

before OFPA and the NOP were born. OFPA and the NOP merely but significantly codified these 

principles into law and regulation. While both emphasize the importance of soil quality and 

conscientious soil management and the practices that impact and influence both, soil conservation

has often been given short shrift in recent public discourse, albeit unintentionally. The days of the 

Dust Bowl and the acute attention to programmatic soil conservation that came with it are far 

behind us, the legacy of those days’ remains, of course, and our responsibility for that legacy 

remains robust. 

The following paragraph is also taken from a NRCS webpage.

“The NRCS draws on a long history of helping people help the land. For more than 75 years, NRCS 

and its predecessor agencies have worked in close partnerships with farmers and ranchers, local and 

state governments, and other federal agencies to maintain healthy and productive working 

landscapes. It is the NRCS role to provide national leadership and technical assistance for the 

conservation of our natural resources to ensure the continued production of food and fiber.” 

The passage of the Food Security Act of 1985 (P.L. 99-198), (with its Sodbuster, Swampbuster, and 

Highly Erodible Lands provisions) made conservation a prerequisite for participation in USDA 

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programs. In order for organic operators to participate in, and benefit from conservation program 

investments, they are required to submit conservation plans if they have erosion problems. Because 

the NOP and the NRCS have common goals, this discussion document presents an ideal opportunity 

to solicit feedback regarding the similarities and differences in their implementation requirements 

for soil and water conservation practices. The NOSB values the opportunity to collaborate with 

partners such as the NRCS.

In closing, our hope is to generate meaningful dialogue within the organic community to identify 

and evaluate opportunities for improving soil and water practices in organic farming and livestock 

operations. We offer this platform as a means for thoughtful discourse and responsible discussion to 

propose solutions where applicable and to strive for continual process improvement. We welcome 

your answers to the questions below in preparation for the fall, 2014 NOSB meeting.

V. QUESTIONS:

1) How do certifiers assess whether production practices, identified in an organic system plan 

and/or observed on-site, maintain or improve soil quality? Is visual assessment sufficient?

2) What tools, other than visual inspection, could aid certifiers in evaluating soil management 

practices, e.g., Revised Universal Soil Loss Equation 2 (RUSLE2) or soil organic matter levels? 

3) What benchmarks do certifiers have for issuing noncompliance’s related to soil conservation: for 

instance, visible erosion, overgrazing, and evidence of manure application on frozen ground, 

manure or compost stored in flooded areas? Are quantitative benchmarks used?

4) What qualifications do certifiers seek among inspectors for evaluating soil management 

practices on-site? 

5) What tools do inspectors use (other than soil testing) to evaluate/measure the adequacy of soil 

management during on-site inspections? Is one on-site inspection enough to assess erosion if it 

is done during a single visit?

6) How do certifiers respond if a review/on-site inspection indicates that there is a soil 

management problem? Do certifiers issue notices of noncompliance or note as a finding to be 

reassessed at a later time?

7) How do certifiers respond when complaints are filed about a producer’s soil management?

8) Some USDA benefits require producers to be in compliance with Highly Erodible Land (HEL) 

provisions. Are certifiers aware of USDA Natural Resource and Conservation Service (NRCS) 

classification and HEL provisions? Should certifiers verify whether production acreage is 

classified as “highly erodible land” (HEL) and ensure appropriate soil management practices for 

HEL? 

9) Are certifiers aware of USDA NRCS’s tolerable soil loss standards? Should certifiers verify 

whether production acreage has been assessed to meet tolerable and sustainable soil loss 

levels? 

10) When NRCS personnel who provide technical assistance on organic operations observe soil 

management risks and problems should the producer be required to communicate this 

information to their certifier?

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National Organic Standards Board

Livestock Subcommittee

Findings and Recommendation in Response to September 2010 NOP Memorandum

Livestock Vaccines Made With Excluded Methods - Proposal

August 19, 2014

I. Introduction: 

Vaccines are critical for the prevention of disease and to prevent needless suffering of livestock. For the 

vast majority of diseases for which a vaccine may be used there is a vaccine available which is not made 

with excluded methods. However, most certifiers do not require producers to document that the livestock 

vaccine used is not made with excluded methods. The National Organic Standards Board (NOSB), working 

with the National Organic Program (NOP), has spent considerable time over the last several years reviewing 

how best to address the issue of vaccines made with excluded methods in order to be in compliance with 

the Organic Food Production Act (OFPA) and the Regulations. The NOSB unanimously passed a resolution 

requesting that the NOP help obtain a comprehensive list, similar to the coded list of registered vaccines 

maintained by the Animal Plant Health Inspection Service (APHIS) that could be provided to the NOSB and 

certifiers, to help guide policy and practice. However, attempts to create such a list have not been 

successful. One key finding of our work to date is that the definition of “excluded methods” requires 

revision, and that the use of the term “GMO” (genetically modified organism), while commonly used, 

nationally and internationally, reflects an oversimplification. This document outlines the central issues 

related to vaccine use in organic livestock production, and notes that 7 CFR Section 205 allows for petitions 

for specific vaccines made with excluded methods. We also present the history of NOSB work to clarify 

apparent inconsistencies in practice, review in brief the complexity of the definition of “excluded methods”, 

reiterate some of the Working Group Interim Report, provide a synthesis of public comment received, 

comments on international vaccine use, and recommend that the NOP provides Guidance on this subject. 

II. Background:

In 2009 the NOSB commented on the use of livestock vaccines. They noted that with no antibiotics used in 

organic livestock production, the basic measure of prevention through use of vaccines is critical to the 

health of the animals. They pointed out that all vaccines are produced in federally regulated and licensed 

facilities and in November 2009 the NOSB recommended that all vaccines be allowed, as practiced at that 

time, in order to prevent disease and needless suffering of livestock, with the caveat “that vaccines made 

by non-excluded methods be used before those made by excluded methods” (Board Vote: Yes-11; No-2; 

Abstain - 0; Absent- 2)

In September 2010 the NOP asked the NOSB to formally review GMO vaccines in accordance with the 

criteria in Section 205.600. The NOSB requested a Technical Report which would address the evaluation 

criteria as specified in the Act (7 U.S.C 6517 and 6518).

In November 2011 the Technical Report, “Vaccines made from Genetically Modified Organisms”, was 

received by the NOP. This document provided some critical information to the NOSB

The NOSB conducted a review of Vaccines made with excluded methods using the Checklist and criteria as 

specified at 205.600. The NOSB prepared a Proposal dated April 3, 2012, for public comment and possible 

vote at the Public Meeting in May 2012. This proposal included the following recommendations: 

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“This recommendation concerns the class of livestock vaccines derived from excluded methods, 

commonly called GMO vaccines. There are approximately 73 registered animal vaccines, of which 

13 are GMO. Only 2 vaccines, Bovine and Avian Salmonellosis, appear to be presently available only 

as GMO. At present livestock producers use all vaccines and are not required to determine if they 

are using non-GMO (conventional) or GMO derived vaccines. GMO vaccines are not legally allowed 

in organic production. This recommendation proposes a change which will allow GMO vaccines only 

in a declared emergency and, further, that at such time producers could use GMO vaccines without 

losing organic status of livestock. The recommendation also proposes changes to the definition of 

“emergency treatment program”. The entire recommendation applies to the class of vaccines 

derived from excluded methods, but does not foreclose petitions for individual vaccines or a class 

of vaccines to treat specific diseases.”

Recommended Committee Action & Vote, 

1. Modify language in 205.238 (6) as follows, change shown in italics.

Administration of vaccines and other veterinary biologics, provided, vaccines produced with 

excluded methods, can only be administered in accordance with §205.105(e).

2. Modify 205.105 (e) as follows: Excluded methods, except for vaccines: Provided, 

(1) such vaccines are administered only due to a Federal or State emergency pest or disease 

treatment program, and 

(2) such vaccines are approved in accordance with §205.600(a);

3. Modify language in 205.603(a)(4) as follows: Biologics—Vaccines, provided, with regard to 

vaccines produced with excluded methods, the requirements of 205.105(e) are satisfied. 

4. Change the Definition of “Emergency pest or disease treatment program” in section 205.2 with 

the additions shown in italics.

Emergency pest or disease treatment program: A mandatory program authorized by a Federal, 

State or local agency for the purpose of controlling or eradicating a pest or disease, except for a 

program requiring substances described in section 205.105(e) regarding only vaccines produced 

with excluded methods, in which case such program is defined as a mandatory treatment program 

authorized by a declared Federal or State emergency for the purpose of controlling a pest or 

disease.”

Based upon public comment and the need for additional technical information before voting, the NOSB 

decided to table the proposal until a future meeting, but passed a resolution.1 The resolution requested: 1) 

That NOP identify all vaccines registered with USDA as GMO or non GMO; 2) That Vaccine manufacturers 

voluntarily and truthfully label vaccines about their absence of GMO content; and 3) That the NOP or other 

USDA agency publish a real time tracking system to identify GMO and non GMO vaccines.

In response to the NOSB’s May 2012 resolution, the NOP convened the Vaccines Made With Excluded 

Methods (MWEM) Working Group. The working group included two members of the NOSB, NOP staff, and 

staff from the Center for Veterinary Biologics (CVB), the division in the Animal Plant and Health Inspection 

Service (APHIS) that approves and regulates vaccines for use in livestock and pets.2

1 http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5098924

2

 Working Group Participants: 

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In February 5 2013 the Working Group prepared an Interim Report summarizing its work, and this report 

was sent to the Livestock Subcommittee and subsequently was posted to gather public comment. 

In April 2013 an update was provided at the Public Meeting. 

(Note that there was no public meeting in fall 2013 owing to government shutdown).

In April 2014 the results of a pilot project analysis conducted by one certifier was presented as part of the 

Livestock Subcommittee report indicating that none of the vaccines used by livestock producers certified by 

that certifier were made with excluded methods according to verification received by the certifier from 

manufacturers. The NOSB requested further comment from certifiers.

In summer 2014 the Accredited Certifiers Association (ACA) conducted a simple survey amongst its 

certifiers which indicated that because of the considerable complexity of verification there is a lack of 

consistency nationwide in how certifiers are verifying that vaccines used in organic livestock production are 

not made with excluded methods.

III Relevant Areas of the Rule:

 

The USDA organic regulations at 7 CFR part 205 contain several references that are relevant to the 

discussion on the use of vaccines in organic livestock production. 

The first reference, under the “Livestock healthcare practice standard”, requires that “the producer must 

establish and maintain preventive healthcare practices, including... administration of vaccines and other 

biologics” (205.238(a)(6)). 

The second reference on the National List of Allowed and Prohibited Substances allows the use of livestock 

vaccines, which are synthetics as follows: 205.603(a)(4) as follows: “Biologics – vaccines” (205.603(a)(4)) 

(without annotation). 

The third reference at 205.672 deals with emergency pest or disease treatment which is defined in 205.2 as 

a “mandatory program authorized by a Federal, State or local agency for the purpose of controlling or 

eradicating a pest or disease.” The OFPA Statute (7 USC 6506(b)(2)) refers to exemptions for organic “farms 

subject to a Federal or State emergency pest or disease treatment program.” This suggests that Congress 

did not intend to include locally declared programs. In the past, vaccines MWEM have been required as 

part of disease eradication programs. It is unclear as to the effects of these eradication programs on organic 

livestock producers. 

The fourth reference is: 

Section 205.105 Allowed and prohibited substances, methods, and ingredients in organic 

production and handling. 

Melissa Bailey, PhD, Director, Standards Division, National Organic Program, AMS-USDA* 

Scott Updike, PhD, Agricultural Marketing Specialist, National Organic Program, AMS-USDA 

Patricia Foley, DVM, PhD –Center for Veterinary Biologics (CVB), APHIS 

Nick Maravell, Organic Producer Representative & NOSB Livestock Subcommittee Member 

Jean Richardson, PhD, Consumer/Public Interest Representative & NOSB Livestock Subcommittee Member 

(* indicates working group facilitator) 

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“To be sold or labeled as “100 percent organic”, “organic,” or “made with organic (specified 

ingredients or food groups)”, the product must be produced or handled without the use of:...

(e) Excluded methods, except for vaccines: Provided, That, the vaccines are approved in accordance 

with 205.600 (a).”

Section 205.600 (a) “Evaluation criteria for allowed and prohibited substances, methods and ingredients” 

specifies: 

“The following criteria will be utilized in the evaluation of substances or ingredients for the organic 

production and handling sections of the National List: 

205.600(a) Synthetic and nonsynthetic substances considered for inclusion on, or deletion from, 

the National List of allowed and prohibited substances will be evaluated using the criteria specified 

in the Act (7 U.S.C. 6517 and 6518)”. 

Thus, under this section (205.105(e)), the use of excluded methods is prohibited in organic production. 

 

To date the NOSB has not recommended any vaccines made with excluded methods be added to the 

National List. 

Excluded methods are defined under the USDA organic regulations (205.2):

“A variety of methods used to genetically modify organisms or influence their growth and 

development by means that are not possible under natural conditions and processes and are not 

considered compatible with organic production. Such methods include cell fusion, 

microencapsulation and macroencapsulation, and recombinant DNA technology (including gene 

deletion, gene doubling, introducing a foreign gene, and changing positions of genes when 

achieved by recombinant DNA technology). Such methods do not include traditional breeding, 

conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture. “

The methods that are excluded and, thus, prohibited, are those used to genetically modify organisms or 

influence their growth and development by means that are not possible under natural conditions or 

processes and are not considered compatible with organic production. 

IV Discussion:

The preamble to the final rule (65 FR 80554) in 2000 discussed the NOP’s response to comments about use 

of vaccines MWEM in organic livestock production. Some commenters wanted all vaccines MWEM to be 

completely prohibited from organic livestock production while others wanted all vaccines to be temporarily 

allowed until more information could be assembled in the future to determine if any of the vaccines 

MWEM were necessary for production. At the time, NOP chose to structure the provision so that vaccines 

MWEM could only be used by organic production if they are affirmatively included on the National List after 

review by the NOSB. But, with no information or guidance about how to identify vaccines MWEM, many 

organic livestock producers, with approval from their certifiers, have chosen vaccines based upon disease 

prevention and not based on whether they are made with excluded methods. 

To rectify this divergence between regulatory language and industry practice, the NOSB, in 2009, 

recommended a change to section 205.105(e) to allow the use of vaccines made with excluded methods if 

vaccines made without excluded methods were not commercially available. That recommendation stated 

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that such a change would not require individual review of vaccines made with excluded methods. The NOP 

has not implemented this change into the USDA organic regulations. Therefore, the current exception at 

section 205.105(e) to allow vaccines made with excluded methods only applies to those that are reviewed 

according to 205.600.

In September 2010, the NOP requested that the NOSB review vaccines made with excluded methods (i.e. 

GMO vaccines or genetically engineered vaccines) in accordance with section 205.600. 

The Livestock Subcommittee requested a Technical Review of GMO Vaccines which used the criteria found 

at 7 U.S.C. 6517 and 6518. The Livestock subcommittee drafted a proposal and submitted it to the full 

Board. The NOSB discussed the proposal pertaining to the use of vaccines MWEM at its May 2012 public 

meeting. The NOSB received considerable public comment on this issue leading up to and at this public 

meeting. Comment was split with members of the general public advocating for a prohibition on vaccines 

MWEM and certifiers and producers asking for more detailed information about current vaccine use and 

clarification about which vaccines were MWEM. Due to the need for additional technical information 

before voting, the NOSB decided to table the proposal until a future meeting, but passed a resolution that 

included a request for more information from USDA. 

In response to the NOSB’s May 2012 resolution, the NOP convened the Vaccines Made with Excluded 

Methods Working Group. 

The Working Group first collected information regarding the use of vaccines, government programs that 

may require the use of vaccines, technical information about how vaccines are made and how vaccines are 

regulated. In response to requests from the NOP, CVB and Veterinary Services (VS) from APHIS elaborated 

on regulations that could require livestock producers to use vaccines. The working group’s understanding is 

that the Secretary of Agriculture has the authority to declare emergencies at various levels depending upon 

the severity of the outbreak. Emergency declarations allow both state and the federal government to 

require livestock producers to use specific vaccines, including vaccines MWEM. The only regional 

emergency in the past decade was an Exotic Newcastle outbreak in unvaccinated backyard poultry and 

game fowl. No vaccination program was used in this emergency because USDA determined that most 

commercial poultry operations in the area, whether conventional or organic, had already vaccinated their 

birds for this disease.

The working group also learned that disease eradication programs authorized by the federal government 

may include mandated use of vaccines. The two recent eradication programs, Brucellosis in cattle and 

Pseudorabies in swine both required vaccines. These two eradication programs used vaccines that allow 

blood tests to differentiate between those animals that have an immune response due to the vaccine and 

those animals that have an immune response due to the disease. In order to differentiate between 

vaccinated animals and animals which had the disease, producers must use a modified live vaccine that 

results in a strong immune response, has mutations that alter at least one epitope and is not virulent. The 

Brucellosis vaccine was developed using cell culture passages, a presumably allowed technology in organic 

production. The Pseudorabies vaccines, several vaccines were approved for this eradication program, were

developed using excluded methods. Based on discussions with APHIS, the working group believes that 

vaccines made with excluded methods may be USDA’s preferred vaccine choice in future eradication 

programs. 

APHIS’ CVB regulates vaccines and vaccine manufacturers under the Virus-Serum-Toxin Act. CVB’s primary 

role is to review and license vaccines based upon purity, safety, potency, and efficacy. CVB requires certain 

label terms depending upon specific configurations of the vaccine seed (form of the agent used to create 

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the vaccine). CVB also tracks vaccines that are made through the use of biotechnology. However, CVB’s 

evaluation of whether a vaccine is produced through “biotechnology” does not align well with how 

“excluded methods” is defined under the USDA organic regulations. Because of this lack of alignment, it is 

difficult to know the extent to which vaccines on CVB’s list of biotechnology derived vaccines overlaps with 

what could be considered produced through an “excluded method”. CVB does review the use of 

biotechnology in manufacturing of the vaccines, e.g. if a vaccine is produced using cells made with excluded 

methods. However, if only the cell line used to culture the vaccine seed has a genetic insertion, deletion or 

other mutation, the vaccine itself is not considered to be a recombinant. 

Finally, the working group could not identify a comprehensive path of “partial” alignment such that if a 

vaccine were identified as biotechnology derived by CVB then it is was definitely considered made with 

“excluded methods” as defined by the NOP.

It must also be noted that European organic standards allow the use of all vaccines if they are needed to 

prevent a disease in the area. Canadian organic standards forbid genetically engineered vaccines outright. 

In addition, Canadian organic livestock producers may only use a nongenetically engineered vaccine that 

was grown in a cell culture system that included genetic modifications if no other vaccine is available. 

After considering background research, information from other USDA agencies and public comments, the 

Working Group came to the conclusion that developing criteria for certifiers and Material Evaluation 

Programs (MEPs) to use to identify vaccines MWEM would be the only approach to allow the organic 

industry to determine which, if any, vaccines made with excluded methods are being used and if there are 

reasonable alternatives to these vaccines. 

The working group considered creating a list of all vaccines produced with (or without) use of excluded 

methods. This would be the easiest resource for organic livestock producers and certifiers to use. However, 

creation of a negative and/or positive list is difficult for a variety reasons, including the lack of precise 

criteria to decide whether something should be considered produced through excluded methods. 

Furthermore, for such lists to be useful, the lists would need to specify the branded vaccine products that 

livestock producers purchase and use, not just generic names of the disease or pathogen that is being used 

to create the vaccine. Another reason the working group chose not to create a list is that the CVB does not 

differentiate vaccines based upon excluded methods. USDA is concerned that creating such a list would 

imply a deficiency of vaccines MWEM, which would not be scientifically accurate within USDA’s 

responsibility to regulate the purity, safety, potency, and efficacy of vaccines. The working group was also 

concerned 1) with liabilities due to the possibility of inaccurately placing a specific vaccine on a list, and 2) 

the possibility of not being able to obtain necessary vaccine manufacturing information, which is often 

submitted as confidential business information to APHIS CVB.

The working group identified criteria that would allow certifiers and MEPs to identify vaccines MWEM. The 

three criteria to be used in conjunction are: 

• _Label Guidelines 

• _Product Codes 

• _Methods of Production Analysis 

Label Guidelines: CVB regulations require that certain vaccine seed configurations have specific terms on 

the labels of branded vaccine products. These terms are required for a subset of biotechnology derived 

vaccines. While these terms are not added to the labels because an excluded method was used, CVB states 

that all such vaccines were created using methods that the NOP would exclude. The terms on labels that 

identify vaccines were made with excluded method are “Subunit,” “Vector,” and “Chimera.” Because these 

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vaccines are labeled with the identified terms, CVB can disclose a trade names list for all of these vaccines. 

Vaccines must be labeled with the term “Subunit” when the vaccine is an extracted or purified protein that 

was expressed in a recombinant system. These vaccines do not contain any genetic information (DNA). 

These vaccines only contain the protein antigen that induces an immune response. To create “Subunit” 

vaccines, the gene for the antigenic protein is inserted into an expression vector or expression system. The 

gene from the pathogenic organism may be expressed in prokaryotic or eukaryotic cell culture systems. The 

expressed protein is then extracted or purified and used in the vaccine. Currently there are no active 

licenses for subunit vaccines. 

Certain modified live vaccines must be labeled with the term “Vector” or “Chimera” to denote that the 

vaccine contains DNA from two pathogens. These vaccines are created by identifying a viral structure that 

induces a strong immune response. This viral structure is termed the expression vector. In many cases, the 

expression vector is a virus that in its unaltered form can cause a disease in the target species. The vector 

will then have at least one gene from another disease causing agent inserted into the viral genome. 

Vaccines labeled with “Vector” may be efficacious against two diseases, the disease caused by the 

unaltered vector and the disease caused by the source of the gene that was inserted into the vector or only 

be efficacious against the disease caused by the source of the gene that was inserted into the vector. 

Vaccines labeled with “Chimera” are similar to “Vector” labeled vaccines, except that certain genes 

required for replication competency are supplied by the added genes and not contained in the expression 

vector. 

Product Code: The CVB requires that every biologic, including vaccines, produced must have a product

code. The CVB guide on true names and product codes notes that the 5th digit of the product code may 

contain “D” or “R.” The letter “D” in the fifth digit signifies that the vaccine is a nucleic acid vaccine. Such 

vaccines, also called DNA vaccines, are made with excluded methods and depend upon foreign genes being 

expressed in some of the cells of the vaccinated animals. The letter “R” in the fifth digit signifies the vaccine 

has a recombinant component or is a subunit protein derived from a recombinant organism. The 

recombinant designation only applies to components in the vaccine and not to methods used to make the 

vaccine such as genetically engineered cells that are used for cell culturing the vaccine seed. 

In public comments, some certifiers stated that they were aware of the R code in the fifth digit of the 

product code as designating that a component in the vaccine was recombinant or recombinant-derived. 

However, these certifiers were not able to translate the product code information to actual vaccines on the 

market. CVB is unable to provide a list of the trade names of the vaccines with a “D” or “R” in the product 

code because confidential business considerations will not permit discussion of production methods, unless 

the biologics firm specifically agrees to disclose the information. The working group was unable to develop 

a method to identify the trade names of vaccines and other biologic products that have a D or R in the 

product code other than the trade names that are already identified as MWEM, e.g. are labeled as 

containing a “Vector” or “Chimera.” Vaccines that have a “D” or “R” in the product code may or may not be 

made with excluded methods since the production methods may not be identified for evaluation. The 

working group requested input from the NOSB and the organic community to identify methods of linking 

product codes to trade names in a manner that clearly identifies whether or not an excluded method was 

used. The pilot project by one certifier in 2013 and by the ACA in 2014 provided some analysis of the use of 

vaccines in practice.

Method of Production Analysis: Some firms have waived confidentiality by describing how the vaccines 

were made in public comment to the NOSB. However, some vaccines were and in the future may be made 

with methods that are not clearly excluded or allowed in organic production. The working group requested 

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input from the NOSB and the organic community to provide comments on this issue. 

Modified live vaccines generally have been found to produce greater immune responses in vaccinated 

animals and have become more common in new vaccines than killed vaccines. Live vaccines require that 

the genome of the disease causing organism be modified to create a living, but not virulent, pathogen 

which can be packaged in the vaccine. The excluded methods definition (205.2) includes methods which 

genetically modify organisms or influence their growth and development by means not possible under 

natural conditions or processes which are not considered compatible with organic production. The 

definition identifies some of the methods that are excluded including recombinant DNA technology (gene 

deletion, gene doubling, introducing a foreign gene and changing the positions of genes when achieved by 

recombinant DNA technology). The definition states that some methods to genetically modify organisms 

are allowed, including traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization or 

tissue culture. 

Many of the older non-biotechnology derived modified live vaccines were made by using bacterial culture, 

cell culture or tissue culture with multiple passages to induce genetic modifications, including gene 

deletions, to the disease causing pathogen. The various cultures were then screened to identify a modified 

version that induced an immune response but that was no longer virulent. This is a process of random 

genetic modification followed by screening for the desired phenotype. The Brucellosis vaccine that is part 

of the Brucellosis eradication program was produced by growing the parent strain in various concentrations 

of an antibiotic cocktail over several passages to induce random mutations in the genome of the bacteria. 

These random mutations resulted in a non-virulent bacterial strain that did not produce the O-chain 

component of the lipopolysaccharide that was one of the epitopes for immune response. This change in at 

least one epitope was required for eradication programs so that vaccinated animals could be differentiated 

from animals infected by the actual pathogen. 

The working groups assumed other genetic modification methods that would be allowed are exposure to 

chemical or physical mutagens. Physical mutagens include ionizing radiation, UV radiation and radioactive 

decay. These mutagens create genetic modifications in a random manner through a variety of ways. Some 

chemical mutagens break the double stranded DNA, allowing a recombination event to occur which can 

cause gene deletion and changing the position of genes. Other mutagens cause DNA bases to switch to 

other bases, errors in DNA repair or errors in replication. These mutagens all genetically modify organisms 

in a random manner that is not targeted. Generally, the vaccines working group considered chemical and 

physical mutagens to be traditional breeding techniques. Biological mutagens are excluded if they are 

considered to be a recombinant technology. Recombination is the process by which double stranded DNA is 

broken, rearranged and then rejoined. Recombination naturally occurs between chromosomes during the 

process of meiosis to form gametes for sexual propagation, in plants, animals and other organisms. 

Recombination naturally occurs during high frequency recombinant (Hfr) conjugation in which part of the 

chromosome from one bacterium is transferred to another bacterium, resulting in homologous 

recombination which genetically modifies the target bacteria. These are just two examples of genetic 

modifications through recombination events which are allowed by the current definition of excluded 

methods. 

Some biological mutagens are clearly excluded by the current definition. Restriction enzymes are naturally 

occurring proteins in many bacteria that will cleave DNA at specific sequences. These enzymes are defense 

against phage (viruses that target bacteria) which insert their genetic material, usually but not always DNA. 

Restriction enzymes have been used to cleave a gene of interest and then through a targeted 

recombination event create a specific gene deletion, clone the gene in a vector or cause a changing of 

positions of genes in a controlled, nonrandom manner. 

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Other biological mutagens are neither explicitly allowed or excluded and may be allowed when used one 

way but not when used in a different way. Specifically, the working group discussed the methods used to 

create a vaccine which the manufacturer has stated, in public comments to the NOSB, was not made with 

excluded methods. This particular gene-deleted product was created using transposons and phage 

transduction. Transposons and phage transduction both result in genetic modifications mediated through 

recombination events. However, the working group was divided as to whether or not these methods were 

excluded. Are these methods considered traditional breeding techniques? 

Transposons, also called transposable elements are naturally occurring, double stranded DNA sequences 

with a defined structure. Each end of the transposon includes inverted repeats. In prokaryotes, the internal 

structure includes at least one gene for transposase and may contain many more depending upon the type 

of transposon. Genes for antibiotic resistance, one example of the types of genes within the transposon 

occur both naturally and sometimes as a marker in lab modified transposons. When the transposase gene is 

expressed, the protein binds to the inverted repeats of the transposon, cleaves the genomic DNA and 

excises the transposon. Transposase can then cleave the genomic DNA at another spot and recombine the 

transposon into a new position in the genome.

In order to evaluate the use of transposons in vaccine production, the working group considered if 

transposons would fit into the allowance for traditional breeding techniques. The working group was not 

clear at which point traditional breeding techniques are divided from modern or non-traditional breeding 

techniques. Is there a time point at which all techniques before that time are considered traditional and all 

new techniques developed after that time are not considered traditional? The definition of excluded 

methods allows all traditional breeding techniques, so the distinction is important for organic producers.

The other method used by the vaccine manufacturer under discussion was transduction, which is the 

process through which the genomes of bacteria can be modified with the use of bacterial virus, called a 

phage. Some types of phage attach to the bacterial cell wall and insert the viral genome into the cell. The 

viral genome may then be inserted into the bacterial genome through a recombination event which is part 

of the lysogenic cycle. After receiving a trigger, the viral genome will be excised and the lytic cycle will be 

triggered. The excision of the viral genome is not perfect and in some cases, parts of the bacterial genome 

will be excised and packaged into the new phage. The phage can then be used to infect additional bacteria. 

The bacterial genetic material in the phage will be inserted into the newly infected cell. A homologous 

recombination event may occur so that some of the genes from the originally infected cell’s genome will 

replace the genes in the newly infect cells. This method can stably introduce genetic mutations into the 

new bacteria.

The working group did not come to a decision about the status of vaccines developed using these methods. 

Certifiers and MEPs who examine vaccines for compatibility with the organic regulations will need guidance 

on future determinations of other vaccines as well. 

Public Comment on the Interim Report of the Working Group, and the subsequent efforts of Certifiers to 

clarify how to verify use of vaccines not Made With Excluded Methods, clearly reflects the frustration of 

certifiers and producers seeking to be fully compliant with the regulations, while needing to ensure the 

health of organic livestock.

Here are some samples of public comment:

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“Any expectation of verifying vaccines made with excluded methods will need a clear and practical 

framework of how to determine compliance. Even with a stricter rule regarding GM vaccine use, there will 

likely need to be some exceptions because some critical vaccines are only available from GM sources.”

“We find that the technology itself is quite difficult for the layperson to understand, and phrases such as 

“excluded methods” and “traditional breeding” are surprisingly challenging to define. “

“One of the most difficult aspects of understanding the use of genetic engineering in vaccines is the lack of 

disclosure to the public or public understanding about these techniques. Without government regulation 

and increased disclosure, it will be very difficult for organic agriculture to make strides in the goal of 

refraining from the use of vaccines developed using excluded methods.”

“Developing a clearer definition of “excluded methods,” although outside of the scope of the Vaccines 

Working Group’s Interim Report, was discussed as an option in that report.”

“It seems clear that the definition needs to be revised. Certifiers experience difficulty interpreting 

“excluded methods” at present, especially because the language of the NOP’s definition does not always 

align with the language used by vaccine manufacturers. However, revision of terminology must be done 

extremely carefully. We ask that, in any revision of the definition, or tightening of restrictions on vaccines, 

be done with consideration of the following questions:

1) GE is an evolving technology. How are producers, veterinarians, certifiers, and the NOP to keep up with 

the knowledge needed to interpret these evolving techniques?

2) When considering implementation of a stricter rule with regard to GM vaccine use, how far back into the 

development or manufacture of a substance should the excluded methods prohibition apply? How far back 

is practical and verifiable? As indicated in the recent discussion document, many challenges exist in this 

area.”

“We are informed that Canadian Organic Standards prohibit all GE vaccines. How are Canadian certifiers 

able to verify this, especially given the international nature of the pharmaceutical supply chain? In terms of 

implementing a system of transparency in this area, is there anything we can learn from Canadian 

certifiers?” 

“In the case that a reliable system of disclosure is developed and implemented, it will be essential for the 

National List to include certain vaccines that, while essential, are not available except through genetic 

engineering. One of our foremost concerns is a Salmonella vaccine for poultry. We also need to take into 

account emergency situations and eradication programs that may require the use of vaccines developed by 

excluded methods. Overall, food safety needs to be our largest concern.”

“In our experience, it is too much to expect certifiers and material review organizations to be able to 

analyze the effects of each method to determine if the genetic modifications are random or targeted. In 

order to make this determination on a consistent basis, the organizations would have to have geneticists or 

equally qualified staff. This is simply too difficult to achieve on a regular basis, given the amounts of 

vaccines and combinations of brand names that certifiers have to review every year. Thus, it is logical to 

suggest that a given technique should be declared excluded or allowed.”

“Vaccines are also used in other countries as well. Those vaccines are regulated and labeled differently 

internationally and we cannot expect that international certifiers should be held to different standards. 

Please consider the international implications of any final recommendation that the livestock 

subcommittee proposes.

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A veterinarian commented: “The working group is to be commended for their extensive work on this 

subject. The relevant issues have been identified and described. The group has solicited input from 

certifiers and the greater organic community. This is not a simple topic with clearly defined boundaries 

and limits. I encourage the NOSB and NOP to approach this area with a system of regulation that is not

rigid but will be open to further review and rule modification as time progresses and technology continues

to evolve.”

In summary: Organic livestock producers, certifiers and material evaluation programs can, theoretically, 

identify certain vaccines as being produced with excluded methods by the presence of the words 

“chimera,” “vector,” or “subunit” on the label of the vaccine. However, in practice, this is an extremely 

difficult process, and thus there is lack of consistency in verification that livestock vaccines used in organic 

livestock production are not Made with Excluded Methods. Given this complexity and the need for revision 

of the definition of excluded methods, as detailed in this report, NOP Guidance is needed on how to make a 

determination of whether a vaccine has been produced with Excluded Methods. Actions could eventually 

include a rule change. It is certainly clear that the definition of excluded methods seems to be a less than 

ideal fit with vaccine production methods. 

Motion: The Livestock Subcommittee requests that the NOP review this document and provide Guidance 

to the NOSB, certifiers and MRO’s on the use of Vaccines MWEM in organic Livestock production.

Motion by: Jean Richardson

Seconded by: Colehour Bondera

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

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB, August 26, 2014

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National Organic Standards Board

Crops Subcommittee

Protecting Against Contamination in Farm Inputs

Preliminary Bibliography and Discussion Document

August 19, 2014

I. Introduction

Organic farmers have always made use of organic materials from a wide range of on-farm and off-farm 

sources—in compost, some plant materials without prior composting, mined minerals, and animal byproducts such as fish or slaughterhouse waste. OFPA addresses residues of such materials in agricultural 

harvested crops. However, residues of pesticides, heavy metals, genetically engineered organisms, and 

other contaminants are problems not only for the consumer, but also for the grower, and the regulations 

require their management in a way that protects crops, soil, and water. Residues may reach the organic 

farm through different media, but here we are concerned about protecting the farmer from contamination 

coming from off-farm inputs used directly from these sources.

The purpose of this discussion document is to share the research results obtained by the Crops 

Subcommittee so far and collect public input, with the aim of identifying more experts and ultimately 

proposing a process for addressing contamination of inputs that may be brought onto the farm. It is the 

plan of the Subcommittee to meet with experts and receive additional public comments as part of the 

process for determining whether the NOSB should propose recommendations on this subject.

This review identifies resources that document issues associated with contamination of farm inputs --those 

materials that are brought into or added to the organic system and may be contaminated with residuals of 

synthetic or natural materials not permitted in organic production. Of course, there are also concerns with 

unavoidable residual environmental contaminants, which are a separate but related issue. For example, 

there may be some land areas that are so contaminated by background levels or ongoing contamination 

(through water and air) that the viability of the organic operation is threatened. 

To ensure the quality of organic food, investigating sources of potential contaminants and ultimately 

adopting uniform preventive measures to avoid contamination of organic systems is important. Some 

examples of topics that have become issues in the last few years include:

• Heavy metal contamination of manure, compost, mined minerals and fish products.

• Neonicotinoid residues that could harm pollinators when taken up by plants.

• Insecticide residues such as bifenthrin that can be detected in compost

• Excessive foreign materials in compost and green waste.

• Antibiotic residues in manures that can result in tetracycline-resistant bacteria.

• Genetically engineered plant material that may or may not break down in compost and soil.

This review starts with an examination of pathways by which contaminants may enter organic production 

systems, products, and eventually consumers.

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II. Some Contamination Incidents

In 2010, bifenthrin was found in commercially available composts. California Department of Food and 

Agriculture prohibited use of compost from three producers in organic production.1 NOP allowed use of the 

compost as unavoidable residual environmental contamination (UREC).2

A 2005 ATTRA publication advised that, “Poultry litter applied at agronomic levels, using good soil 

conservation practices, generally will not raise arsenic concentrations sufficiently over background levels to 

pose environmental or human health risks. However, recent studies show that more than 70% of the 

arsenic in uncovered piles of poultry litter can be dissolved by rainfall and potentially leach into lakes or 

streams. Thus, organic producers must take care when they handle and apply poultry litter.”3 In 2011, 

Consumers Reports documented significant arsenic concentration in rice, including organically grown rice.4

 

III. Pathways

A. Fertilizers/Soil Amendments 

Fertilizers contain trace amounts of heavy metals as impurities, which may build up in the soil. Application 

of certain phosphate fertilizers also adds heavy metals to the soil, including cadmium, fluorine, mercury, 

and lead.

Heavy metal contamination may come from inputs of organic matter:

The application of numerous biosolids (e.g., livestock manures, composts, and municipal sewage sludge) to 

land inadvertently leads to the accumulation of heavy metals such as As, Cd, Cr, Cu, Pb, Hg, Ni, Se, Mo, Zn, 

Tl, Sb, and so forth, in the soil.... Although most manures are seen as valuable fertilizers, in the pig and 

poultry industry, the Cu and Zn added to diets as growth promoters and As contained in poultry health 

products may also have the potential to cause metal contamination of the soil. The manures produced from 

animals on such diets contain high concentrations of As, Cu, and Zn and, if repeatedly applied to restricted 

areas of land, can cause considerable buildup of these metals in the soil in the long run.5

Compost and mulch materials are probably the most common vehicle for contaminants above unavoidable 

residual environmental contamination levels to arrive on organic farms. Heavy metals, pesticides, and 

antibiotics are among the contaminants that arrive in organic materials used for compost and mulch. 

Nevertheless, “Considerable remediation of the hazardous wastes or contaminated plants, soils, and 

sediments can be accomplished by composting. High microbial diversity and activity during composting, 

due to the abundance of substrates in feedstocks, promotes degradation of xenobiotic organic compounds, 

such as pesticides, polycyclic aromatic hydrocarbons (PAHs), and polychlorinated biphenyls (PCBs).”6

 

1 OMRI, 2010. Composts Disallowed in California and An Update on Pesticide Residues,

http://www.omri.org/news/81937/compost-update-pesticide-residues 

OMRI, 2010. An Update on Pesticide Residues in Compost- Part 2, http://www.omri.org/news/85720/updatepesticide-residues-compost-part-2 2 USDA, 2010. NOP 5016, Guidance: Allowance of Green Waste in Organic Production Systems.

3 Barbara C. Bellows, 2005. Arsenic in Poultry Litter: Organic Regulations, www.attra.ncat.org/attrapub/PDF/arsenic_poultry_litter.pdf

4 http://www.consumerreports.org/cro/magazine/2012/11/arsenic-in-your-food/index.htm Arsenic in your food: Our 

findings show a real need for federal standards for this toxin. 5 Raymond A.Wuana and Felix E. Okieimen, 2011. Heavy Metals in Contaminated Soils: A Review of Sources, 

Chemistry, Risks and Best Available Strategies for Remediation. ISRN Ecology, Volume 2011, Article ID 402647. 6 Allen V. Barker and Gretchen M. Bryson, 2002. Bioremediation of Heavy Metals and Organic Toxicants by 

Composting. The Scientific World JOURNAL (2002) 2, 407–420.

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Heavy metals cannot be destroyed by composting, but may be converted into organic compounds or 

chelates that are less bioavailable than inorganic metal compounds. On the other hand, heavy metals may 

also become concentrated because of the removal of carbon in the composting process. 7

Contamination with herbicides is a particular problem because it can cause damage to plants.8 It is 

recognized that although composting destroys many pesticide residues, it does not necessarily eliminate 

toxic impacts:

“The nature of the organic contaminant, composting conditions and procedures, microbial communities, 

and time all affect mechanisms of conversions in composts or soils.... The Büyüksönmez review noted that 

mineralization of organic pesticides was only a small fraction of pesticide degradation, with other 

prominent fates of the pesticides being partial degradation to secondary compounds, adsorption to 

compost, and volatilization....The secondary compounds may be as, or more, toxic than the original 

pesticide. Losses by volatilization essentially mean that the pesticide has been moved from one place to 

another. If recalcitrant materials, including metals, are present in feedstock, they may be unchanged or 

concentrated during composting. Recalcitrant pesticides are persistent and may show no changes during 

composting or have a half-life of a year or more. ...Destruction of pesticides depends on the pesticide and 

on the substrate in which the pesticide is undergoing co-composting.... The general conclusion from 

research with pesticide degradation by composting was that pesticide concentrations were lowered to 

nonhazardous levels for crops in soils receiving the composts. However, if pesticides that are persistent or 

recalcitrant to degradation are present in the feedstock, special care may be needed not to use the 

compost on sensitive crops in the year in which the compost was made. Caution may need to be taken in 

some cases not to grow plants in 100% compost in containers.” 9

Herbicides of the class known as pyridine carboxylic acids, which includes aminopyralid, clopyralid, 

fluroxypry, picloram, and triclopyr, are registered for use on pasture, grain crops, and lawns, among other 

sites. “[S]ome of these herbicides can be persistent and may remain active in the hay, straw, grass clippings, 

and manure, even after they are composted. Some of these herbicides have a half life of 300 days or more 

and aminopyralid has been reported to remain active in compost for several years.... Most of these 

herbicides have a rotational crop restriction of at least 18 months for vegetable crops. When used as 

7 Allen V. Barker and Gretchen M. Bryson, 2002. Bioremediation of Heavy Metals and Organic Toxicants by

Composting. The Scientific World JOURNAL (2002) 2, 407–420. 8 Herbicide Carryover in Manure and Hay: Caution to Organic Farmers and Home Gardeners 

http://compostingcouncil.org/admin/wp-content/uploads/2012/07/Herbicide-Carryover.pdf

United States Composting Council, 2011. Composter Alert: New DuPontTM Herbicide “ImprelisTM” Will Persist in 

Compost. http://compostingcouncil.org/admin/wp-content/uploads/2011/05/Imprelis-alert-final1.pdf 

EPA, 2011. Imprelis stop sale letter. http://www.epa.gov/pesticides/regulating/imprelis-stopsale-letter.pdf

US Composting Council, 2013. USCC Position: Persistent Herbicides. http://compostingcouncil.org/admin/wpcontent/plugins/wppdfupload/pdf/9199/USCC%20Position%20Statement%20on%20Persistent%20Herbicides%20FINAL.pdf 

US Composting Council, 2014. USCC comments on registration of picloram. http://compostingcouncil.org/admin/wpcontent/plugins/wp-pdfupload/pdf/9199/USCC%20Picloram%20Reregistration%20Comments%20Final.pdf

Frederick C. Michel, Jr. and Douglas Doohan, Clopyralid and Other Pesticides in Composts. Ohio State University 

Extension, publication AEX-714-03. http://ohioline.osu.edu/aex-fact/pdf/0714.pdf 9 Allen V. Barker and Gretchen M. Bryson, 2002. Bioremediation of Heavy Metals and Organic Toxicants by 

Composting. The Scientific World JOURNAL (2002) 2, 407–420.

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directed on the labels, these herbicides should not cause these problems. The problems arise when the hay, 

manure, grass clippings, etc. leave the hands of the individual who applied the herbicides.”10

The U.S. Composting Council has been particularly concerned about contamination of compost with 

persistent herbicides. In a position paper on persistent herbicides, it says,

11

“Herbicide-contaminated compost is not a new problem. The first incidents of herbicide contamination 

in compost were reported in 2000 in Spokane, Washington, where compost produced from yard 

trimmings contaminated with clopyralid damaged vegetable and garden crops....

Since the first incident, evidence of compost contamination by persistent herbicides has been 

documented throughout the United States, including California, Oregon, Pennsylvania, Texas, Maine, 

New Jersey, New York, Kansas, Idaho, North Carolina, Minnesota, and Vermont....

In Vermont in 2012, the Green Mountain Compost facility (owned by the Chittenden Solid Waste 

District, CSWD) received 510 confirmed complaints of herbicide damage to a variety of garden plants 

and ended up paying 449 claims. Settling those complaints and retrieving unsold product from its 

resellers, cost CSWD an estimated $270,000. CSWD incurred another $372,000 for testing and legal 

assistance to address the issue. The loss in value added sales of products that could not be made or 

sold due to the presence of persistent herbicides added another estimated $150,000. CSWD’s costs 

totaled approximately $792,000. The culprit? Mainly aminopyralid, although other primary persistent 

herbicides of concern (clopyralid and picloram) were also found in compost. That regulators were 

unable to identify all sources of contamination is a most troubling aspect of this incident.

Other troubling aspects of the Vermont experience:

The compost was found to cause plant damage with concentrations of aminopyralid as low as 1 ppb.

No government or independent lab exists in the United States that can adequately test for 

aminopyralid in compost at or below the 1 ppb level.

Only the persistent herbicide manufacturers (Dow AgroSciences and DuPont) are currently capable of 

testing for herbicides in complex matrices with high organic content such as composts and manures at 

the low part-per-billion levels at which sensitive garden plants are impacted.

Lack of testing capability contributed to Green Mountain Compost’s loss of value added sales. 

Regulators could not determine the source of the contamination; that is, which feedstock accepted by 

the facility was contaminated with aminopyralid.

...The most common pathway known for persistent herbicides making their way into compost is 

through manures and bedding, although grass clippings and other yard debris can be contaminated as 

well.” 

Persistent insecticides are also a problem in compost and mulch materials. As mentioned above, bifenthrin 

was found in commercially available composts in 2010. California Department of Food and Agriculture 

10 Jeanine Davis, 2009. Herbicide Carryover in Manure and Hay: Caution to Organic Farmers and Home Gardeners. 

North Carolina State University, Mountain Horticultural Crops Research and Extension Center. 

http://compostingcouncil.org/admin/wp-content/uploads/2012/07/Herbicide-Carryover.pdf 11 US Composting Council, 2013. USCC Position: Persistent Herbicides. http://compostingcouncil.org/admin/wpcontent/plugins/wppdfupload/pdf/9199/USCC%20Position%20Statement%20on%20Persistent%20Herbicides%20FINAL.pdf

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prohibited use of compost from three producers in organic production.12 NOP allowed use of the compost 

as unavoidable residual environmental contamination (UREC).13

Neonicotinoids pose a more defined threat. They are applied to seeds and plants, and are taken up by the 

plants. They remain in plant residues and accumulate in soils, and can later be taken up by other plants. 

Very minute quantities are hazardous to honeybees and other pollinators that might consume pollen, 

nectar, or sap from plants containing residues of these insecticides.14

Another form of contamination in compost is heavy metals, especially arsenic, from poultry litter.

Composting concentrates arsenic in poultry litter. Water and carbon dioxide lost during composting reduce 

the litter volume by 25 to 50% and the litter weight by 40 to 80%. Thus, poultry litter that contains 30 ppm 

arsenic before composting will contain 50 to 150 ppm arsenic after composting.15

Newspaper is used both as a mulch and as an ingredient in compost. There is a lack of clarity about 

contaminants in newspaper, derived from both paper processing and inks. The current listing on §205.601 

is for “newspaper or other recycled paper, without glossy or colored inks.” The U.S. Composting Council 

argues that paper is a beneficial addition to compost. “Paper products contain very low levels of 

contaminants, in most cases below those found in yard waste.”16 However, a 1991 risk assessment 

considered the cancer risk associated with applying newspaper to farmland:

Newspaper consists primarily of carbon black dye, mineral oil, and paper. Carbon black contains 

approximately 0.1% polycyclic aromatic hydrocarbon (PAH) impurities. The EPA has found that certain 

paper products contain 10–100 ppt dioxin. Newsprint has not yet been evaluated. Since the production of 

newsprint is unlikely to create many dioxins, the lower range figure of 10 ppt was used. The cancer risk 

from vegetarian vegetable consumption, based on the levels of these two contaminants, was evaluated for 

both a 200 and 5 ton/acre application rate. The potential risk from contaminated vegetable exposure 

ranged from 1 × 10−3 to 2.5 × 10−5 for PAH and from 7.2 × 10−6 to 1.8 × 10−7 for dioxin.17 

This risk, which does not include glossy or colored inks, exceeds EPA’s “negligible risk” level of 10-6. On the 

other hand, a 1992 study found no significant differences in heavy metals in soils mulched with newspapers 

compared to soils not receiving newspaper.18 Although blogs and popular literature abound with claims 

that since today’s newspapers are printed with soy-based inks, there should not be a risk associated with 

newspapers as mulch or a compost ingredient, these claims do not appear to be based on scientific 

research, so more investigation is needed.

12 OMRI, 2010. Composts Disallowed in California and An Update on Pesticide Residues,

http://www.omri.org/news/81937/compost-update-pesticide-residues 

OMRI, 2010. An Update on Pesticide Residues in Compost- Part 2, http://www.omri.org/news/85720/updatepesticide-residues-compost-part-2 13 USDA, 2010. NOP 5016, Guidance: Allowance of Green Waste in Organic Production Systems. 14 Goulson, D. (2013), REVIEW: An overview of the environmental risks posed by neonicotinoid insecticides. Journal of 

Applied Ecology, 50: 977–987. 15 Barbara C. Bellows, 2005. Arsenic in Poultry Litter: Organic Regulations, www.attra.ncat.org/attrapub/PDF/arsenic_poultry_litter.pdf

16 US Composting Council, 2010. Factsheet: The Benefits of Including Paper in Composting. 

http://compostingcouncil.org/admin/wp-content/uploads/2010/09/Benefits-of-Including-Paper-in-Composting.pdf 

Although dated 2010, all references are much older.

17 J. A. Bukowski , 1991. Cancer Risk from the Application of Newspaper to Farmland. The Analysis, Communication, 

and Perception of Risk Advances in Risk Analysis Volume 9, pp 267-274. 18 David A. Munn, 1992. Comparisons of Shredded Newspaper and Wheat Straw as Crop Mulches. HortTechnology 

2(3): 361-366. http://horttech.ashspublications.org/content/2/3/361.full.pdf

Page 77 of 104
Manure from animals raised in nonorganic agriculture often contains residues of antibiotics fed to the 

animals. These residues may or may not decompose during composting. Dolliver et al studied the effects of 

three forms of composting –a manure pile with no disturbance after initial mixing, a compost pile turned 

weekly and adjusted for moisture, and compost made in a rotating drum—to determine whether the 

practices made a difference in the decomposition of four antibiotics. There was no difference among 

treatments, but there was a substantial difference among antibiotics. Chlortetracycline degraded almost 

completely (>99%), monensin and tylosin were reduced 54-76%, and sulfamethazine did not degrade at 

all.19

Pesticide products used in organic production or that end up in composted material may be contaminated 

with substances that are active ingredients in other products.20 EPA’s Pesticide Registration Manual states, 

EPA evaluates the composition data to determine whether impurities could constitute a significant 

component of the residues in food and feed commodities. Impurities that arise in the manufacture of 

pesticides can become a residue problem if they are not identified before tolerances are established. 

Dioxins and nitrosamines are the best-known examples of significant impurities of toxicological concern. If 

impurities are at levels that may lead to toxicologically significant residues in crops or the environment, 

then adjustments to the manufacturing process or additional purification steps will be necessary to reduce 

the impurities to a safe level.21

A level that is not “toxicologically significant” under the Federal Insecticide, Fungicide, and Rodenticide Act 

(FIFRA) may nevertheless be considered the addition of a nonpermitted material in organic production if 

not put on the National List. Information about impurities in pesticide products is not easily available, but 

arsenic levels from 3 to 100 ppm (3, 7.2, <10, <10, 10, <25, 100) have been found in copper sulfate products 

available as fertilizers, according to the Washington State Department of Agriculture fertilizer database.22 

Six fertilizers containing rock phosphate and approved for use in organic production by the Washington 

State Department of Agriculture contain arsenic at levels from <1 to 75 ppm, cadmium from 2 to 49 ppm, 

and lead from 5 to 47 ppm.23 However, a 2004 report by the California Department of Food and Agriculture 

found that in most cases, applications of phosphate and micronutrient fertilizers resulted in little increase 

in soil concentrations of arsenic, cadmium, and lead.24

B. Irrigation

The three main problems that can arise from the quality of irrigation water are salinity, sodicity or 

alkalinity, and toxicity.25 Pathogens may also be a problem in some cases.26 Sundquist (2007) summarizes 

the extent of the problem for the U.S. and California.27

19 Holly Dolliver, Satish Gupta, and Sally Noll, 2008. Antibiotic Degradation during Manure Composting. J. Environ. 

Qual. 37:1245–1253. 20 EPA, 1996. Toxicologically Significant Levels of Pesticide Active Ingredients. PR Notice 96-8. 

http://www.epa.gov/PR_Notices/pr96-8.pdf 21 EPA, 2010. Pesticide Registration Manual: Chapter 11 –Tolerance Petitions. 

http://www.epa.gov/pesticides/bluebook/chapter11.html 22 http://agr.wa.gov/PestFert/Fertilizers/FertDB/Product1.aspx 23 http://agr.wa.gov/PestFert/Fertilizers/FertDB/Product1.aspx 24 Andrew C. Chang, Albert L. Page, and Natalie J. Krage, 2004. Role of Fertilizer and Micronutrient Applications on 

Arsenic, Cadmium, and Lead Accumulation in California Cropland Soils, final report submitted to California 

Department of Food and Agriculture. www.cdfa.ca.gov/is/docs/cdfafinalreport.pdf 25 I.P. Abrol, J.S.P. Yadav, and F.I. Massoud, 1988. Salt-Affected Soils and their Management. Ch. 6, Water Quality and 

Crop Production. FAO Soils Bulletin 39 Food and Agriculture Organization of the United Nations, Rome.

Page 78 of 104
In the U.S., 

 

• 20% of irrigated land suffers from salinization.

• About 21% of irrigated cropland is fed by drawing down water tables.

• About 25% irrigated land suffers from some degree of salinization or waterlogging.

• Salt accumulation is lowering crop yields on 25-30% of irrigated land.

• 25% of irrigated soils were salty or alkaline to the point where productivity was lowered.

• Dry cropland areas in the western US where production has ceased or is significantly reduced due to 

increased salinity is growing at 10%/ year.

In California,

• About 25% of irrigated land has undergone moderate- to heavy salinization.

• The amount of water-storage capacity lost through aquifer compaction in the Central Valley is over 40% 

of the combined storage capacity of all human-made reservoirs in California.

• Some 1620 km2 of irrigated farmlands in San Joaquin Valley are affected by high, brackish water tables, 

resulting in a 10% reduction in productivity since 1970. 

• San Joaquin Valley crop yields have declined 10% ($31.2 million) since 1970 because of high saline 

water tables. Losses are expected to increase to $321 million/ year if action is not taken.

• Not far below the surface of San Joaquin Valley and Imperial Valley (like the Tigris-Euphrates Valley) is a 

tight layer of material that blocks water passage. Hence saltwater builds up. When it meets the roots of 

plants, salt is drawn up to the surface, destroying the irrigation system.

• Imperial Valley (Southern California) experienced about 90% of the agricultural damage from salinity in 

the US portion of the Colorado River Basin. 

• 85% of the water reaching rivers in the Grand Valley is irrigation water, carrying salt from marine shales 

that lie under local farms.

All irrigation water contains salts that may harm plants, and most are left in the soil after the water 

evaporates from the soil or leaves through transpiration. Unless salts are leached from the root zone, they 

will eventually accumulate in quantities that will affect growth of most crops. Management practices for 

efficient use of high salinity water include more frequent irrigation, selection of salt tolerant crops and 

varieties, use of extra water for leaching, conjunctive use of fresh and saline waters, and cultural 

practices.28

Sodicity or alkalinity “develops when irrigation water contains relatively more sodium ions than divalent 

calcium and magnesium ions while the total concentration of salts is generally not very high. Accumulation 

of sodium ions on to the exchange complex results in a breakdown of soil aggregates responsible for good 

soil structure needed for free movement of water and air through the soils.” Management practices for 

efficient use of water presenting a sodicity hazard include application of amendments, mixing with an 

alternative source of water, irrigating more frequently, growing crops with lower water requirements, 

26 Irrigation Water as a Source of Contamination, www.ugacfs.org/producesafety/Pages/Basics/Water.html 27 Bruce Sundquist, 2007. Irrigated Lands Degradation: A Global Perspective. Ch. 5, Degradation of Irrigated Land. 

http://home.windstream.net/bsundquist1/ir5.html 28 I.P. Abrol, J.S.P. Yadav, and F.I. Massoud, 1988. Salt-Affected Soils and their Management. Ch. 6, Water Quality and 

Crop Production. FAO Soils Bulletin 39 Food and Agriculture Organization of the United Nations, Rome.

Page 79 of 104
growing tolerant crops, and adding organic matter.Water treatments, such as the addition of sulfurous 

acid, have also been used to treat alkalinity. 29 Sulfurous acid for this purpose is on the National List.30

Toxic substances such as boron or heavy metals may be introduced through irrigation water. Boron, for 

example is an essential element for plant growth and nutrition, but is needed only in trace quantities. High 

concentrations can have a toxic effect on the growth of many plants. Similarly, other ions, e.g. chloride, 

sodium, etc., could prove toxic to specific crops if present in excessive quantities. Other elements that may 

be present --such as lithium, selenium, molybdenum, fluoride and chromium—may exert toxic deleterious 

effects on plants or animals at very low concentrations. 31

Starting in 1985, the National Irrigation Water Quality Program (NIWQP) conducted a series of field 

investigations at 26 areas in the Western United States to examine the impact of irrigation drainage on fish, 

wildlife, humans, and beneficial uses of water. It examined samples of water, bottom sediment, and biota 

for analysis of trace elements and pesticides and identified contaminants most commonly associated with 

irrigation drainage by comparing concentrations in water with established criteria. “Selenium was the trace 

element in surface water that most commonly exceeded chronic criteria for the protection of freshwater 

aquatic life; more than 40 percent of the selenium concentrations in surface-water samples exceeded the 

U.S. Environmental Protection Agency (USEPA) aquatic-life chronic criterion (5 micrograms per liter).” Other 

significant contaminants were boron, molybdenum, arsenic, and uranium. The most common pesticides 

exceeding criteria were DDT and its degradation products DDD and DDE, and chlordane in bottom 

sediments.32

The Food and Agriculture Organization concludes:

Field practices that can eliminate or reduce the hazard due to presence of toxic elements include 

irrigating the crops more frequently. Frequent irrigations reduce the effective concentration of toxic 

constituents and therefore their adverse effect. Occasional application of excess water to leach the 

salts will further reduce the amounts of toxic elements in the root zone. Accumulation of sodium in 

plant parts can usually be reduced by maintaining a favorable concentration of calcium ions in the soil 

solution. Adequate quantities of calcium in the irrigation water and soil solution prevent excessive 

uptake of sodium by plants. Application of amendments, such as soluble calcium salts or sulphuric acid, 

can therefore greatly reduce the toxicity hazard due to excess sodium. Blending of water supplies, 

planting less sensitive crops, improving drainage conditions through profile modification, use of 

fertilizers in optimum doses to obtain otherwise vigorously growing plants etc. are some of the other 

practices that will help overcome toxicity problems. 33

29 I.P. Abrol, J.S.P. Yadav, and F.I. Massoud, 1988. Salt-Affected Soils and their Management. Ch. 6, Water Quality and 

Crop Production. FAO Soils Bulletin 39 Food and Agriculture Organization of the United Nations, Rome. 30 NOSB final recommendation for sulfurous acid, 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5078046&acct=nosb 

Harmon Systems International petition for sulfurous acid to be added to §205.601. 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057561 31 I.P. Abrol, J.S.P. Yadav, and F.I. Massoud, 1988. Salt-Affected Soils and their Management. Ch. 6, Water Quality and 

Crop Production. FAO Soils Bulletin 39 Food and Agriculture Organization of the United Nations, Rome.

32 Ralph L. Seiler, Joseph P. Skorupa, David L. Naftz, and B. Thomas Nolan, 2003. Irrigation-Induced Contamination of 

Water, Sediment, and Biota in the Western United States—Synthesis of Data from the National Irrigation Water 

Quality Program. U.S. Geological Survey Professional Paper 1655. 33 I.P. Abrol, J.S.P. Yadav, and F.I. Massoud, 1988. Salt-Affected Soils and their Management. Ch. 6, Water Quality and 

Crop Production. FAO Soils Bulletin 39 Food and Agriculture Organization of the United Nations, Rome.

Page 80 of 104
Water used both in production and processing of leafy greens may be a source of pathogens. High demand 

and pollution of water resources mean that high quality water for these purposes has become increasingly 

scarce, leading to increased reuse of water, which may increase the hazard of biological contamination with 

pathogens. 34

C. Genetically Engineered Plant Material

Studies have shown that some DNA from genetically engineered plants may persist in the soil.35 Genes may 

move via horizontal gene transfer to soil bacteria, with unknown impacts on soil communities.36

Composting appears to greatly reduce the amount of transgenic DNA.37

D. Contamination in the Field 

As mentioned above, heavy metal contaminants cannot be destroyed by composting, but may be converted 

into organic compounds or chelates that are less bioavailable than inorganic metals. On the other hand, 

heavy metals may also become concentrated because of the removal of carbon in the composting 

process. 38Although many pesticides and other contaminants may be destroyed by composting before 

reaching the field, “The effects of composting on pesticides are not always favorable. The secondary 

compounds may be as, or more, toxic than the original pesticide.”39 

Goulson (2013) notes that although data on persistence of neonicotinoids taken up by plants are scarce, 

some studies indicate long term persistence in plant tissue, which could lead to contamination of organic 

soils if those plants (e.g., wheat straw) were used as mulch or compost additions. Limited studies show 

significant accumulation of imidocloprid with repeated applications.40

IV. Testing Resources for Avoiding Contaminated Inputs

The U.S. Composting Council (USCC) has a seal of testing assurance (STA) program that analyzes compost 

for ten properties: pH, soluble salts, nutrient content (total N, P2O5, K2O, Ca, Mg), moisture content, 

organic matter content, bioassay (maturity), stability (respirometry), particle size (report only), pathogen 

34 Irrigation Water as a Source of Contamination, www.ugacfs.org/producesafety/Pages/Basics/Water.html This 

website provides a list and highlights of articles examining the prevalence and fate of pathogens in environmental 

water sources; a table listing the results from several surveys examining the prevalence of pathogens in environmental 

water sources; and a list of review articles dedicated to the discussion of pathogens in environmental water sources. 35 Kari E. Dunfield and James J. Germida, 2004. Impact of Genetically Modified Crops on Soil- and Plant-Associated 

Microbial Communities. J. Environ. Qual. 33:806–815. Franco Widmer, 2007. Assessing Effects of Transgenic Crops on 

Soil Microbial Communities. Adv Biochem Engin/Biotechnol (2007) 107: 207–234. Alessandra Pontiroli, Pascal Simonet 

, Asa Frostegard , Timothy M. Vogel, and Jean-Michel Monier, 2007. Review article: Fate of transgenic plant DNA in 

the environment. Environ. Biosafety Res. 6 (2007) 15–35. 36 Kari E. Dunfield and James J. Germida, 2004. Impact of Genetically Modified Crops on Soil- and Plant-Associated 

Microbial Communities. J. Environ. Qual. 33:806–815. Franco Widmer, 2007. Assessing Effects of Transgenic Crops on 

Soil Microbial Communities. Adv Biochem Engin/Biotechnol (2007) 107: 207–234. Alessandra Pontiroli, Pascal Simonet 

, Asa Frostegard , Timothy M. Vogel, and Jean-Michel Monier, 2007. Review article: Fate of transgenic plant DNA in 

the environment. Environ. Biosafety Res. 6 (2007) 15–35. 37 Lasse Dam Rasmussen, Jacob Møller and Jakob Magid, 2004. Composting rapidly degrades DNA from genetically 

modified plants. Newsletter from Danish Research Centre for Organic Farming, June 2004, No. 2. 

http://www.darcof.dk/enews/june04/gmo.html

38 Allen V. Barker and Gretchen M. Bryson, 2002. Bioremediation of Heavy Metals and Organic Toxicants by 

Composting. The Scientific World JOURNAL (2002) 2, 407–420. 39 Allen V. Barker and Gretchen M. Bryson, 2002. Bioremediation of Heavy Metals and Organic Toxicants by 

Composting. The Scientific World JOURNAL (2002) 2, 407–420. 40 Goulson, D. (2013), REVIEW: An overview of the environmental risks posed by neonicotinoid insecticides. Journal of 

Applied Ecology, 50: 977–987.

Page 81 of 104
(Fecal Coliform or Salmonella), and trace metals (Part 503 regulated metals.) The protocols for the various 

tests that are used are contained in ‘Test Methods for the Examination of Composting and Compost’ 

(‘TMECC’), jointly published by the USDA and USCC.41 TMECC does not include standards against which the 

test results can be measured, nor does it include methods for residues of pesticides, antibiotic, or other 

anthropogenic chemicals. Bioassays provide a low cost method to test for herbicide residues.42 The 

National Organic Program Handbook contains guidance for residue testing, including choosing a lab for 

testing of pesticide residues.43

V. Experts

The Crops Subcommittee has identified the following as areas of expertise in which it should identify 

possible experts for consulting with the subcommittee:

• Testing, known levels of contamination, problem identification.

• Compost professionals who are familiar with contaminants in compost.

• Laboratory people who work with organic who know how to test and what shows up. 

• Organic agronomists who can discuss loading rates (application rates over time) of various materials. 

• Certifiers and government officials who have had to investigate problems where contamination may or 

may not have been behind the problem. 

• Researchers who have studied uptake by plants from raw manure.

VI. Questions

The Crops Subcommittee seeks input in the following areas:

1. Contamination incidents in the past.

2. Contaminants of concern.

3. Contamination pathways of concern.

4. Experts and other resources that would assist the subcommittee in its goal of ultimately proposing a 

process for addressing contamination of inputs that may be brought onto the farm.

VII. Committee Vote: 

The Crops Subcommittee moves to accept this document and present it to the public and for full Board 

discussion at the fall 2014 NOSB meeting:

Motion by: Jay Feldman

Seconded by: Zea Sonnabend

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

41 http://compostingcouncil.org/admin/wp-content/plugins/wppdfupload/pdf/34/TMECC%20Purpose,%20Composting%20Process.pdf TMECC overview, 

http://compostingcouncil.org/seal-of-testing-assurance/ USCC testing, 

http://compostingcouncil.org/test-methods-parameters/ USCC test methods and parameters. 42 http://www.calrecycle.ca.gov/organics/threats/Pesticides/Clopyralid/Bioassays.htm WF Brinton, E Evans, and TC 

Blewett, 2006. Reliability of Bioassay Tests to Indicate Herbicide Residues in Compost of Varying Salinity and Herbicide 

Levels. Compost Science and Utilization 14(4): 244-251. 43http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateR&navID=ProgramHandbookN

OPNationalOrganicProgramHome&rightNav1=ProgramHandbookNOPNationalOrganicProgramHome&topNav=&leftNa

v=NationalOrganicProgram&page=NOPProgramHandbook&resultType=&acct=noppub 

Page 82 of 104
Appendix A

Atmospheric Contamination and Siting Concerns

The question of siting organic farms seems to be one that cannot be ignored because of atmospheric 

contamination.

Contaminants may enter organic farms through the air. A study in India found increased concentrations of 

heavy metals in the leafy portions of plants grown in open air, compared to those grown organically in a 

field covered with a greenhouse.44

44 J. Pandey, Usha Pandey, 2009. Accumulation of heavy metals in dietary vegetables and cultivated soil horizon in 

organic farming system in relation to atmospheric deposition in a seasonally dry tropical region of India. 

Environmental Monitoring and Assessment, Volume 148, Issue 1-4, pp 61-74. 

Page 83 of 104

Sunset 2015 Review

Meeting 2 - October, 2014

Crops Subcommittee

Sulfurous Acid

August 20, 2014

As part of the National List Sunset Review process, the NOSB Crops Subcommittee has evaluated the need for the 

continued allowance for or prohibition of the following substances for use in organic crop production.

Sulfurous Acid Synthetic

Use - As plant or soil amendment. 

Listing: Sulfurous acid (CAS # 7782-99-2) - for on-farm generation of substance utilizing 99% purity elemental sulfur per 

paragraph (j)(2) of this section. 

Technical Reports: 2010 TAP; 2014 TR 

Original Petition: Sulfurous Acid (2008) 

Past NOSB Actions: Recommended for addition to the National List on 5/2009 

Regulatory Background: Proposed rule (including justification) published 1/12/2010 (75 FR 1555). Added to National List 

7/6/2010 (75 FR 38693). 

Sunset Date: 7/7/2015

Reference 7 CFR 205.601(j)(9) 

Subcommittee Review

The Crops Subcommittee believes that the full Board should have the opportunity to complete the review of each 

sunset material by voting. The NOP has stated that to do this a motion to remove should be brought from the 

Subcommittee for each substance. If the Subcommittee motion to remove fails to receive a majority, the motion will 

still be put forward to the full board for review. The motion to remove is voted by the full Board and needs to receive 

a 2/3 majority to recommend removal.

Summary:

Sulfurous acid was added to the National List in 2009, with the annotation, “on-farm generation of substance utilizing 

99% purity elemental sulfur per paragraph (j)(2) of this section.” The Crops Subcommittee has received a Technical 

Review that contains new information that needs to be considered in the Sunset review:

1. The TR contains information about environmental impacts of sulfurous acid, particularly on soil organisms;

2. There is information on alternative materials and practices that was not considered by the board in 2009;

3. It appears that sulfurous acid might be used to correct the impacts of unsustainable irrigation practices;

4. This use of sulfurous acid is not permitted in organic agriculture in other countries

The Crops Subcommittee posed the following questions in the Spring 2014 meeting announcement:

1. The Crops Subcommittee is interested in the conditions under which sulfurous acid undergoes the transformation to 

sulfate, and conditions under which that sulfate is available as a plant nutrient. The 2014 TR describes the chemistry 

of sulfurous acid in the soil at lines 64-67, 140-149, and 261-264. The subcommittee seeks comments that address 

the following questions: Are there specific soil and ecological (e.g., moisture) conditions under which the 

transformation to sulfate would be made and the sulfate made available? On the other hand, are there soil and 

ecological conditions that would result in the build-up of hydrogen sulfite, sulfate, or other products of sulfurous 

Page 85 of 104
acid? Are there management practices that can be used by the grower to affect whether the transformation occurs 

and the sulfate is available to crops? Are there evaluation tools that can be used by farmers and certifiers to 

determine which of the above soil conditions are present? 

2. The subcommittee would like public input on whether sulfurous acid is used to remedy conditions resulting from 

unsustainable agricultural practices. If so, how can this be evaluated by the NOSB in the sunset review of this 

material? 

The Crops Subcommittee received 8 comments in favor of relisting sulfurous acid and 5 comments opposing relisting. 

Comments in favor of relisting included the following:

1. Sulfurous acid is tool organic growers can use to counteract soil salinity and alkalinity.

2. Sulfurous acid does not act as a sulfate fertilizer because the sulfate is present only at a parts per million level while 

sulfur is a secondary level nutrient (along with calcium and magnesium) that is needed at much higher quantities to 

influence plant growth.

3. Sulfurous acid is a water treatment for poor quality irrigation waters; it is not a remedy for unsustainable farming 

practices.

4. The soil and ecological conditions resulting in the build-up of hydrogen sulfite, sulfate, or other products of sulfurous 

acid would only happen in anaerobic soils with complete water saturation. This is unlikely to happen in the western 

portion of the United States because farmers here are very familiar with the conditions under which irrigation is 

needed.

5. It increases the sustainability of agricultural soils in alkaline environments as its use keeps soil pore space open to 

the air and water helping to leach away toxic salts.

6. Many small berry growers –especially blueberry growers—depend on this technology.

Comments opposing relisting included the following:

1. Specific uses must be delineated as well as conditions under which it can be used.

2. International standards do not allow sulfurous acid in crop production.

3. There are potential adverse impacts that have not been evaluated by the NOSB.

4. The NOSB needs to ask whether the “need” for sulfurous acid reflects unsustainable farming practices.

Conclusion

In reviewing the 2014 Technical Review and materials submitted by commenters, the Crops Subcommittee finds new 

evidence relating to OFPA criteria. There are concerns about compatibility with organic and sustainable systems, and 

also evidence of overall value to organic agriculture especially when saline/alkaline irrigation water quality problems 

exist. For more information, see the attached evaluation checklist. The subcommittee supports research to gather 

additional information needed to address the issues in the checklist.

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

Based on the Subcommittee’s review, the Subcommittee proposes removal of this substance from the National List 

based on the following criteria in the Organic Foods Production Act (OFPA): [OFPA criteria at 7 U.S.C. 6158(m), (7) its 

compatibility with a system of sustainable agriculture.

Motion to remove Sulfurous Acid from the National List

Motion by: John Foster

Seconded by: Harold Austin

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

Page 86 of 104
Minority Statement on Motion to Remove

While the minority of the CS agrees with the majority that the full NOSB should vote on sunset materials, in voting 

against this motion it is following what we believe are required procedure of AMS/USDA as established by the 

September 16, 2013 Federal Register notice (78 FR 56811), which states that motions to remove be justified by criteria 

established by the Organic Foods Production Act. Because of concern that a change in NOSB procedures should be 

disclosed to the public before taking effect, the minority does not accept the compatibility criteria from 7 U.S.C. 6158(m)

(7) that was provided in this case. Furthermore, AMS/NOP has said that no action by the NOSB maintains a sunset 

material on the National List.

Page 87 of 104
Evaluation Criteria (checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☒ Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes ☒ No ☐ N/A

3. Compatibility & Consistency ☐ Yes ☒ No ☐ N/A 

Substance Fails Criteria Category: 2, 3 

NOSB Evaluation Criteria for Substances Added To the National List (Optional Checklist)

Category 1. Adverse impacts on humans or the environment? Sulfurous Acid 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X There is a potential for damage to the local 

ecosystems from improperly maintained 

sulfurous acid generators. TR lines 330-331.

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X Depends on fossil fuel production. TR lines 

251-253.

3. Are there any adverse impacts on 

biodiversity? (§205.200)

Overuse of sulfurous acid and subsequent 

acidification will cause the metabolism of 

microorganisms involved in compost and 

organic matter breakdown in treated 

streams and runoffs to be suppressed along 

the acidity gradient, and can lead to a 

decrease in humus production (Simon, et al., 

2009). TR lines 333-336.

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X TR line 229.

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

? The primary purpose of sulfurous acid for 

crop production is reducing the pH of 

irrigation water to alleviate the effects of 

specific saline/sodic soil conditions or the 

effects caused by saline or sodic irrigation. TR 

lines 295-297

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

material or its breakdown products?

[§6518(m)(2)]

X Sulfurous acid is slightly irritating to the skin, 

and strongly irritating to the eyes. TR lines 

364-365.

7. Is there persistence or concentration of the 

material or breakdown products in the 

environment? [§6518(m)(2)]

X Hydrogen sulfite present in the solution is 

metabolized by sulfite reducing bacteria and 

plants that recycle sulfurous acid into 

bioavailable sulfur compounds. Water and 

other dissolved compounds leach into the 

soils. Functionally, sulfurous acid serves to 

condition soils by adjusting pH. TR lines 261-

264.

Page 88 of 104
8. Would the use of the substance be harmful 

to human health or the environment? 

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

§6518(m)(4)]

? It would be harmful if it discourages adoption 

of farm methods that prevent alkalinization 

and salinization of the soil, which have 

broader impacts than the particular farm 

where sulfurous acid might be used – such as 

creating a progressively more alkaline 

groundwater supply.

9. Are there adverse biological and chemical 

interactions in the agro-ecosystem? 

[§6518(m)(5)]

? Overuse of sulfurous acid and subsequent 

acidification will cause the metabolism of 

microorganisms involved in compost and 

organic matter breakdown in treated 

streams and runoffs to be suppressed along 

the acidity gradient, and can lead to a 

decrease in humus production (Simon, et al., 

2009). TR lines 333-336.

10. Are there detrimental physiological effects 

on soil organisms, crops, or livestock? 

[§6518(m)(5)]

? Overuse of sulfurous acid and subsequent 

acidification will cause the metabolism of 

microorganisms involved in compost and 

organic matter breakdown in treated 

streams and runoffs to be suppressed along 

the acidity gradient, and can lead to a 

decrease in humus production (Simon, et al., 

2009). TR lines 333-336.

Category 2. Is the Substance Essential for Organic Production? Sulfurous Acid 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X TR lines 250-256.

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

X Generally, the source of the sulfur is from 

fossil fuels. TR lines 250-253.

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X See questions #2 and 3.

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X

7. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

X Organic matter, pure sulfur, gypsum, 

compost, citric acid. TR lines 385-388.

8. Are there any alternative substances? 

[§6518(m)(6)]

X See #7. Also, aquatic plant extracts, 

elemental sulfur, lignin sulfonate, humic 

acids and liquid fish extracts TR lines 395-

397.

Page 89 of 104
9. Are there other practices that would make 

the substance unnecessary? [§6518(m)(6)]

X Proper irrigation, control of 

evapotranspiration, lining irrigation canals, 

salt-tolerant crops. TR lines 408-426.

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

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic

farming and handling? 

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

X Not permitted in other countries. TR lines 

184-215. IFOAM specifically states, 

“Operators shall prevent or remedy soil or 

water salinization where these pose a 

problem. Sulfurous acid is used as a remedy 

for salinization of soil” TR lines 214-215

Synthetic fertilizer. TR lines 146-147; 261-

263.

2. Is the substance compatible with a system of 

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

X Used to correct impacts of poor irrigation 

practices. TR lines 127-141.

3. If used in livestock feed or pet food, Is the 

nutritional quality of the food maintained 

with the substance? [§205.600(b)(3)]

X

4. If used in livestock feed or pet food, Is the 

primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is the 

primary use to recreate or improve flavors, 

colors, textures, or nutritive value lost in 

processing (except when required by law)? 

[§205.600(b)(4)]

X

6. 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

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

Page 90 of 104
Sunset 2015 Review 

Meeting 2 - October, 2014

Crops Subcommittee 

Sodium Carbonate Peroxyhydrate

August 19, 2014

As part of the National List Sunset Review process, the NOSB Crops Subcommittee has evaluated the need for 

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

Sodium Carbonate Peroxyhydrate Synthetic

Use - as an algaecide

Listing: Sodium carbonate peroxyhydrate (CAS # 15630-89-4)—Federal law restricts the use of this substance 

in food crop production to approved food uses identified on the product label.

Technical Report: 2006 (PDF); 2014 (PDF) 

Petition(s): : Sodium Carbonate Peroxyhydrate (2005)

Past NOSB Actions: Recommended for addition to the National List on 11/30/07. 

Regulatory Background: Proposed rule (including justification) published 6/3/2009 (74 FR 26591). Added to 

National List 12/13/2010 (75 FR 77521).

Sunset Date: 12/14/2015

Reference: 7 CFR 205.601(a)

Subcommittee Review

The Crops Subcommittee believes that the full Board should have the opportunity to complete the review 

of each sunset material by voting. The NOP has stated that to do this a motion to remove should be brought 

from the Subcommittee for each substance. If the Subcommittee motion to remove fails to receive a 

majority, the motion will still be put forward to the full board for review. The motion to remove is voted by 

the full Board and needs to receive a 2/3 majority to recommend removal.

Summary:

Sodium Carbonate Peroxyhydrate1 was added to the National List in 2007 with the hope that growers would 

use this as an alternative to more problematic materials such as copper and chlorine. However organic 

producers had had no previous experience to draw from with this product and in particular its use in rice, 

which has only been registered since 2010. 

A new TR was commissioned in 2014 to address alternatives, and use patterns. The material is used as an 

algaecide in ponds, ditches and irrigation lines. It can also be used in rice production for scum disease. New 

information provided in that TR was used to prepare this review.

Summarized points from the TR:

o The material is a precursor to hydrogen peroxide and is used widely in household cleaners and 

detergents as well as water bodies. (TR lines 89-100).

1 Sodium Carbonate Peroxyhydrate is the active ingredient in products such as the brands GreenClean, 

GreenClean Pro, Terracyte Pro, and PAK 27 Algaecide

Page 91 of 104
o While most international standards do not mention sodium carbonate peroxyhydrate by name, they 

do allow both hydrogen peroxide and sodium carbonate which are the components and the 

precursors of this substance. (TR lines 164-202).

o There are no new concerns since the earlier review about human health or environmental effects. (TR 

lines 391-434)

o Of the alternatives presented, copper sulfate is clearly the most problematic and also the most widely 

used (on 97,757 acres vs. 1,177 acres in 2010, representing 17.4 and 0.3% of California rice acreage) 

(TR lines 448 - 457).

o Some proposed alternative controls, such as Chinese herbs, garlic extracts, or panchagavya, have not 

been tested in the U.S. and may not be available. (TR lines 487 - 497).

The Crops Subcommittee (CS) posed the following question in seeking public comment on this substance in 

the first posting in Spring 2014:

The subcommittee is seeking input on the comparison of this material to copper sulfate for control of algal 

scum in rice production and whether it can replace copper sulfate for that use.

Only 5 comments were received. Another 4 were received for the cancelled Fall 2013 meeting. While some of 

the comments were against renewing it at sunset and one was in favor, the only one that addressed the 

question posed was the one in favor which came from the original petitioner. The ones against did not 

mention any actual first-hand experience with the substance or the alternatives.

Points raised in favor of renewing substance:

o It has provided better control of algae and its breakdown components of water and oxygen are a 

needed relief from elemental copper accumulation associated with copper based chemistries. 

o In 2014 copper labels have been restricted to a label that is rendered useless when treating algae.

o Sodium carbonate peroxyhydrate has been approved for use in drinking water by the NSF and has also 

been Kosher certified.

o When utilized in irrigation ponds Sodium carbonate peroxyhydrate has less corrosion issues with 

irrigation equipment than copper sulfate.

Points raised against renewing substance:

o It was found by the NOSB in its 2007 recommendation not to meet the OFPA criteria of essentiality, 

compatibility with organic production, and no impacts on human health and the environment. 

o SCP is not permitted in organic production internationally (lines 164-202).

o The TR mentions several materials and a number of alternative practices to reduce algae in ponds and 

rice paddies: Alternatives are available for control of algae: Rice straw, Allelopathic plants, 

Herbivorous fish

o SCP does not fit any OFPA categories.

Additional point raised:

o The annotation for this material is confusing and difficult to interpret for products that are 

manufactured outside of the U.S. or are labeled for other uses beside a pesticide.

o The annotation indicates it is restricted to only those food crops on the label. However, if used as an 

irrigation cleaner, it wouldn’t necessarily have food crops on the label to indicate to the end user 

whether they are in compliance with this annotation.

It is likely that the growers who use or have tried this material did not write in because they did not recognize 

the generic name as being the active ingredient in the product they are using. Therefore the CS hopes that 

product users will submit comments this time, particularly about the efficacy and relevance of the alternatives 

mentioned above and in the TR such as rice straw, allellopathic plants, and herbivorous fish.

The CS did some further investigation into points raised in public comment. In particular the 2007 report of 

Page 92 of 104
the California Rice Research Board that studied the efficacy of this material2 and found that it did not work 

well enough to recommend it for rice paddies. Further investigations into controlling algae by the same group 

in 20103 indicated that management of phosphorus fertilization can influence the severity of algal growth. 

Reducing phosphate concentrations in rice field water was not mentioned in the TR but may be a promising 

alternative practice. 

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

Based on the Subcommittee’s review, the Subcommittee proposes removal of this substance from the 

National List based on the following criteria in the Organic Foods Production Act (OFPA): [OFPA criteria at 7 

U.S.C. 6158(m), (7) its compatibility with a system of sustainable agriculture.

The subcommittee found no concerns regarding the continued listing of Sodium Carbonate Peroxyhydrate. 

The justification for this motion is that the whole NOSB needs to consider and vote on each material, rather 

than just a subcommittee.

Motion to remove Sodium Carbonate Peroxyhydrate from the National List

Motion by: Zea Sonnabend

Seconded by: Harold Austin

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

Minority Statement on Motion to Remove

While the minority of the CS agrees with the majority that the full NOSB should vote on sunset materials, in 

voting against this motion it is following what we believe are required procedures of AMS/USDA as 

established by the September 16, 2013 Federal Register notice (78 FR 56811), which states that motions to 

remove be justified by criteria established by the Organic Foods Production Act. Because of concern that a 

change in NOSB procedures should be disclosed to the public before taking effect, the minority does not 

accept the compatibility criteria from 7 U.S.C. 6158(m) (7) that was provided in this case. Furthermore, 

AMS/NOP has said that no action by the NOSB maintains a sunset material on the National List. 

2 Spencer, David 2007. Annual Report Comprehensive Research on Rice. Project Title: Assessing alternative methods for 

managing algae in California Rice fields. http://www.carrb.com/07rpt/2007%20Spencer%20RP-14.pdf

3 Spencer, David 2010. Annual Report Comprehensive Research on Rice. Project Title: Assessing alternative methods for 

managing algae 2010. http://www.carrb.com/10rpt/Algae.htm

Page 93 of 104
Page 94 of 104
Sunset 2015 Review 

Meeting 2 - October, 2014

Crops Subcommittee 

Aqueous Potassium Silicate

August 19, 2014

As part of the National List Sunset Review process, the NOSB Crops Subcommittee has evaluated the need for the 

continued allowance for or prohibition of the following substances for use in organic crop production. 

Aqueous Potassium Silicate

205.601(e)), 205.601(i)

Synthetic

Use: As insecticides (including acaricides or mite control). As plant disease control.

Listing: Aqueous potassium silicate (CAS #-1312-76-1)—the silica, used in the manufacture of potassium silicate, must be 

sourced from naturally occurring sand.

Technical Reports: 2003 (PDF); 2014 (PDF) 

Petition(s): Aqueous potassium silicate; Aqueous potassium silicate supplemental 

Past NOSB Actions: NOSB review and recommendation for addition to the National List 11/30/07. 

Regulatory Background: Proposed rule (including justification) 6/3/2009 (74 FR 26591). Added to National List 

12/13/2010 (75 FR 77521). 

Sunset Date: 12/14/2015

Reference: 7 CFR 205.601(e)(2)

Subcommittee Review

The Crops Subcommittee believes that the full Board should have the opportunity to complete the review of each 

sunset material by voting. The NOP has stated that to do this a motion to remove should be brought from the 

Subcommittee for each substance. If the Subcommittee motion to remove fails to receive a majority, the motion will 

still be put forward to the full board for review. The motion to remove is voted by the full Board and needs to receive 

a 2/3 majority to recommend removal.

Summary:

In 2007, the Crops Subcommittee recommended against listing Aqueous Potassium Silicate1 (APS) because “multiple 

substitutes are available” and it is a “synthetic soil applied fertilizer not compatible with organic farming regulations.” 

The rationale given for NOSB approval was, “Public comment at Nov. 2007 NOSB meeting well supported listing the 

substance as plant disease control by providing historical 2003 NOSB consideration of the material as well as more 

information from petitioner and other interested stakeholders.”

New information has been provided in a new Technical Review. That information supports the conclusions below. 

(Citations are line numbers in January 6, 2014 TR.)

• Dermal exposure can lead to low to medium systemic toxicity and skin irritation (577-579);

1 Aqueous Potassium Silicate is the active ingredient in products such as the brand Sil-Matrix Fungicide/Miticide.

Page 95 of 104
• Silicon reduces the availability of elements such as manganese, iron, and aluminum to roots (471-473);

• Treatment with potassium silicate may not be appropriate when crops are used for feeding or as forage for 

livestock because it makes some forages less digestible (477-481);

• The addition of potassium silicate as a foliar nutrient may result in the production of less tender fruits and 

vegetables or forage for grazing animals (479-481);

• Silica supplementation can result in elongation and thickening of stems, delayed antithesis and flower 

deformation in some species (487-490);

• In addition to morphological changes, changes in micronutrient in plants may occur as a result of silica 

supplementation (490-491);

• New alternative materials suggested include other forms of silica that are available as approved supplements for 

the soil that can provide the same protection over a longer term against plant disease and compost made with 

silica-rich plants (592-594);

• The TR suggests the following alternative practices: soilscaping, choice of variety and planting time, balancing 

silica accumulators and nonaccumulators, moisture management, choice of mulch and ground cover, and 

scouting (661-706); and

• Internationally (Japan, Canada, EEC, CODEX, or IFOAM), natural sources of silica, not APS, are allowed (258-296).

The Crops Subcommittee invited comment on these conclusions, as well as well as on two major issues of concern at the 

Spring 2014 meeting:

1. Potassium silicate makes plants more resistant to disease and herbivory, at least in part by concentrating silica. 

Humans and livestock are herbivores who might be consuming the treated plants. Does the foliar application of 

potassium silicate might have impacts on the nutritive value of treated foods that would exceed the impacts of silica 

obtained by the plant from natural soils? The TR addressed this to some extent (See #3, 4, and 6 above.) How should 

the NOSB weigh this impact on the nutritive value of treated plants?

2. The central issue in the essentiality question is whether organic management systems that conserve and build 

available silicon in the soil are alternatives to potassium silicate. Thus, the subcommittee received some information 

on this issue (see #7 and 8 above) and is interested in comments concerning nonsynthetic materials and practices 

(involving soil management as well as foliar treatments) that would build comparable resistance to insects and fungi, 

while precluding the need for synthetic potassium silicate.

The NOSB received two comments supporting renewed listing and eight comments opposing renewal. Some specific 

comments that were received are:

• When APS enters the soil from plant treatment it is indistinguishable from silicates already present in the 

ground. 

• APS is used as a foliar application not for roots. 

• “Management systems can be used to build the Si in the soil to improve the plant’s resistance to disease and 

reducing the likelihood of needing a pesticide treatment. However, when an infestation occurs and a treatment 

is required, APS should be an available option for organic farmers.”

• Information is needed on accumulation of silica in plants.

• International standards do not allow aqueous potassium silicate in crop production.

• Organic methods of soil conservation make its use unnecessary.

Conclusion

In reviewing the 2014 Technical Review and materials submitted by commenters, the Crops Subcommittee finds new 

evidence relating to OFPA criteria. There are concerns about impacts on human health and the environment, essentiality 

given alternative materials and practices, and the fact that APS is not allowed in organic production in other countries. 

There is also information that APS fills a need when a problem occurs. The subcommittee supports research to gather 

additional information needed to address the issues identified in the attached checklist. 

Page 96 of 104
Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

Based on the Subcommittee’s review, the Subcommittee proposes removal of this substance from the National List 

based on the following criteria in the Organic Foods Production Act (OFPA): [OFPA criteria at 7 U.S.C. 6158(m), (7) its 

compatibility with a system of sustainable agriculture.

Motion to remove Aqueous Potassium Silicate from the National List

Motion by: Harold Austin

Seconded by: Carmela Beck

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

Minority Statement on Motion to Remove

While the minority of the CS agrees with the majority that the full NOSB should vote on sunset materials, in voting 

against this motion it is following what we believe are required procedure of AMS/USDA as established by the 

September 16, 2013 Federal Register notice (78 FR 56811), which states that motions to remove be justified by criteria 

established by the Organic Foods Production Act. Because of concern that a change in NOSB procedures should be 

disclosed to the public before taking effect, the minority does not accept the compatibility criteria from 7 U.S.C. 6158(m)

(7) that was provided in this case. Furthermore, AMS/NOP has said that no action by the NOSB maintains a sunset 

material on the National List. 

Page 97 of 104
Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

1. Impact on Humans and Environment ☐ Yes ☒ No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes ☒ No ☐ N/A

3. Compatibility & Consistency ☐ Yes ☒ No ☐ N/A 

Substance Fails Criteria Category: 1, 2, 3 

NOSB Evaluation Criteria for Substances Added To the National List (Optional Checklist) 

Category 1. Adverse impacts on humans or the environment? Substance: Aqueous Potassium Silicate 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is there a probability of environmental 

contamination during use or misuse? 

[§6518(m)(3)]

X Since potassium silicate is sprayed onto 

plants, there is a probability of 

contamination. 

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X CO2 produced by manufacture. High energy 

cost, use of fossil fuels. Strong alkaline 

solution produced in manufacture. TAP, pp. 

2, 4, 9-12.

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X Potassium silicate has not been tested for 

ecotoxicity. It is not persistent in aquatic 

systems, but is highly alkaline in solution 

form and can be harmful to aquatic life if not 

diluted and disposed of properly. TAP, p. 4.

4. Does the substance contain inerts classified 

by EPA as ‘inerts of toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X It is/was a List 3 “inert.” TAP, p. 3.

5. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems?

[§6518(m)(1)]

X The substance may react in storage with 

ammonium salts to form hydrogen gas, and 

care should be taken to avoid contact with 

raw manure in closed storage. Potassium 

silicate solutions have a high pH, and 

applications may have adverse effects if used 

on alkali sensitive crops. TAP, p. 3. During 

storage of the compound, care must be 

taken to avoid wetting the material. Spills are 

slippery. Reacts with acids, ammonium salts, 

reactive metals and some organics. TAP, p. 9 

Potassium silicate gels and generates heat 

when mixed with acid and may react with 

ammonium salts resulting in the evolution of 

ammonia gas. Flammable hydrogen gas may 

be produced on contact with aluminum, tin, 

lead, and zinc. TR lines 451-453.2

6. Is there a toxic or other adverse action of the X No carcinogenicity, mutagenicity, or 

2 Line numbers for TR refer to January 6, 2014 final.

Page 98 of 104
material or its breakdown products?

[§6518(m)(2)]

developmental toxicity data are available for 

potassium silicate. TAP, p. 5. Potassium 

silicate has no chronic hazards, does not bioconcentrate in the food chain, nor make 

volatile or toxic organic compounds when 

used as recommended. TAP, p. 11.

7. Is there persistence or concentration of the 

material or breakdown products in the 

environment? [§6518(m)(2)]

X “little to no potential to contaminate or 

persist in the environment.” TAP, p. 9. Use 

will not result in hazardous of 

environmentally persistent byproducts. TAP, 

p. 11.

When dissolved in water, the active 

ingredient potassium silicate dissociates into 

potassium cations, hydroxide anions, and 

mono- and polysilicic acids. When used as a 

pesticide, potassium silicate residues are low 

relative to naturally present concentrations 

and other uses in the environment. TR lines 

522-523; 398-399. 

8. Would the use of the substance be harmful 

to human health or the environment? 

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

§6518(m)(4)]

X Acute overexposure may cause skin and 

respiratory tract irritation. The substance has 

not been tested for primary eye irritation, 

but is regarded as an eye irritant on the basis 

of its high alkalinity and its similarity to 

sodium silicate (Blumberg 2001). Respiratory 

problems in the agricultural sector due to 

inhaled dust are a proven concern (Schenker 

2000). TAP, p. 4

Potassium silicate has not been tested for 

ecotoxicity. It is not persistent in aquatic 

systems, but is highly alkaline in solution 

form and can be harmful to aquatic life if not 

diluted and disposed of properly. TAP, p. 4. 

Not buffered, and a buffered natural system 

is not likely to be affected. TR 387-391. 

Agricultural use of potassium silicate is 

subject to the Worker Protection Standards 

(WPS), requiring Personal Protective 

Equipment (PPE) a long-sleeved shirt, long 

pants, socks, shoes and gloves, plus a 4 hour 

Restricted Entry Interval (REI). TR lines 568-

569. “Results of the acute dermal toxicity 

study indicated moderate to low toxicity at 

the maximum dose tested, although dermal 

irritation was observed.” TR lines 577-579.

9. Are there adverse biological and chemical 

interactions in the agro-ecosystem? 

[§6518(m)(5)]

? Potassium silicate effects on metabolic 

interactions are not well characterized if at 

all. TAP, p. 9. Protective effects would apply 

to weeds as well as crop plants. If used on 

pastures, could affect the pattern of grazing, 

thus affecting species composition. TR lines 

494-497.

Page 99 of 104
10. Are there detrimental physiological effects 

on soil organisms, crops, or livestock? 

[§6518(m)(5)]

X Successive silicate fertilizer applications have 

been shown to increase soil pH to levels that

adversely affect plant growth (Miayke and 

Takahashi 1983), but soils with high organic 

matter content tend to buffer this effect, and 

additions of organic material were effective 

in correcting soil pH. TAP, p. 5. Most impacts 

on soil are positive. TAP, pp. 2, 5, others. . 

Silicon reduces the availability of elements 

such as manganese (Mn), iron (Fe), and 

aluminum (Al) to roots of plants such as rice 

and sugarcane. TR lines 471-473. Treatment 

with potassium silicate may not be 

appropriate when crops are used for feeding 

or as forage for livestock since its addition 

hardens some plants, making them both 

more difficult to chew and digest. 

Furthermore, monosilicic acid naturally 

strengthens the phyto-skeleton, thus the 

addition of potassium silicate as a foliar 

nutrient may result in the production of less 

tender fruits and vegetables or forage for 

grazing animals. TR lines 477-481. Silica 

supplementation can result in elongation and 

thickening of stems, delayed antithesis and 

flower deformation in some species 

depending on the level of accumulation of 

silica by the plant species, the type of silica 

supplement used and the method by which it 

was applied. In addition to morphological 

changes, changes in micronutrient in plants 

may occur as a result of silica 

supplementation. TR lines 487-491 Makes 

certain forage grasses less digestible. TR lines 

494-497.

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

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Potassium silicates are manufactured using a 

calcination process that combines silica sand 

(SiO2) and potassium carbonate (K2CO3) at 

1100-2300°F for up to 15 minutes (NOP 

Petition; Rawlyk and McDonald 2001). The 

two substances fuse into glass, which can be 

dissolved with high-pressure steam to form a 

clear, slightly viscous fluid, or cooled and 

Page 100 of 104
ground into a powder. Carbon dioxide is 

evolved from this reaction. The solution can 

be dried to form hydrous powder crystals of 

potassium silicate. TAP, p. 2

3. Is the substance formulated or 

manufactured by a process that chemically 

changes a substance extracted from 

naturally occurring plant, animal, or mineral 

sources? 

[§6502(21)]

X Potassium silicates are manufactured using a 

calcination process that combines silica sand 

(SiO2) and potassium carbonate (K2CO3) at 

1100-2300°F for up to 15 minutes (NOP 

Petition; Rawlyk and McDonald 2001). The 

two substances fuse into glass, which can be 

dissolved with high-pressure steam to form a

clear, slightly viscous fluid, or cooled and 

ground into a powder. Carbon dioxide is 

evolved from this reaction. The solution can 

be dried to form hydrous powder crystals of 

potassium silicate. TAP, p. 2

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X Petitioned material is synthetic, but some 

natural aqueous potassium silicate is present 

in volcanic soils. TR, line 72.

5. Is there a natural source of the substance? 

[§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X

7. Is there a wholly natural substitute product?

[§6517(c)(1)(A)(ii)]

X Fertilizer: glauconite, TAP p. 6. Azomite, p. 8. 

Disease: A number of foliar treatments to 

control fungal disease are currently used in 

organic agriculture, with research ongoing; 

some of these are agricultural products. In 

one study, an aqueous solution of burnt rice 

husks (400 q/ha) was shown to be as 

effective and economically viable as a 1% 

commercial sodium silicate solution for 

treatment of rice blast (Pyricularia oryzae) 

(Hsieh and Hsieh 1989). Sulfur is by far the 

most widespread treatment for powdery 

mildew and botrytis bunch rot on grapes.

Others...TAP p. 6. More studies are required 

to definitively state that silica is useful to

prevent fungal infections in other crops. The 

necessity of potassium silicate for organic 

production has not been demonstrated. P. 

10. There is no known natural substance 

producing the same short term effect on 

plant health as aqueous potassium silicate in 

a foliar spray. However, other forms of silica 

and application methods for these 

substances are available as approved 

supplements for the soil that can provide the 

same protection over a longer term against 

plant disease. TR lines 591-594. Compost 

made with silica-rich plants. TR lines 596-605. 

Biopesticides. TR lines 609-633. 

Page 101 of 104
8. Are there any alternative substances? 

[§6518(m)(6)]

X See #7.

9. Are there other practices that would make 

the substance unnecessary? [§6518(m)(6)]

X Organic practices including rotation, green 

manures, compost. TAP p. 8, 10. In addition, 

soilscaping, choice of variety and planting 

time, balancing silica accumulators and 

nonaccumulators, moisture management, 

choice of mulch and ground cover, and 

scouting. TR lines 661-706.

Category 3. Is the substance compatible with organic production practices? Substance: Aqueous Potassium Silicate

 

Question Yes No N/A Comments/Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

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

X Unnecessary synthetic input. Synthetic 

fertilizer. Internationally (Japan, Canada, EEC, 

CODEX, or IFOAM), natural sources of silica, 

not APS, are allowed. TR lines 258-296. 

2. Is the substance compatible with a system of 

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

X Unnecessary synthetic input. Synthetic 

fertilizer. High energy requirement for 

manufacture.

3. If used in livestock feed or pet food, Is the 

nutritional quality of the food maintained 

with the substance? [§205.600(b)(3)]

X

4. If used in livestock feed or pet food, Is the 

primary use as a preservative? 

[§205.600(b)(4)]

X

5. If used in livestock feed or pet food, Is the 

primary use to recreate or improve flavors, 

colors, textures, or nutritive value lost in 

processing (except when required by law)? 

[§205.600(b)(4)]

X

6. 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

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X Minerals.

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X

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National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset 2016 Review Summary

Meeting 1: October 2014

Request for Public Comment

Crops Substances

September 2014

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 which must be reviewed by the NOSB and renewed by 

the USDA before their sunset dates in 2016. This list provides the substance’s current status on the 

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

history, as applicable. 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

While the NOSB will not complete its review and any recommendations on these substances until spring

2015 public meeting, the NOP is requesting that the public provide comments about these substances to 

the NOSB as part of the fall 2014 public meeting. These comments should be provided 

through www.regulations.gov by October 7, 2014 as explained in the meeting notice published in 

the Federal Register on September 8, 2014.

These comments are necessary to guide the NOSB’s review of each substance against the criteria in the 

Organic Foods Production Act (7 U.S.C. 6518(m)) and the USDA organic regulations (7 CFR 205.600). The 

current substances on the National List were originally recommended by the NOSB based on evidence 

available to the NOSB at the time of their last review which demonstrated that the substances were 

found to be: (1) not harmful to human health or the environment, (2) necessary because of the 

unavailability of wholly nonsynthetic alternatives, and (3) consistent and compatible with organic 

practices. 

Public comments should focus on providing new information about a substance since its last NOSB 

review. Such information could include research or data that may support a change in the NOSB’s 

determination for a substance. Public comment should also address the continuing need for a substance 

or whether the substance is no longer needed or in demand.

Guidance on Submitting Your Comments

Comments should clearly indicate your position on the allowance or prohibition of substances on the list 

and explain the reasons for your position. You should include relevant information and data to support 

your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.). 

For Comments That Support Substances Under Review:

If you provide comments in support of an allowance of a substance on the National List, you should 

provide information demonstrating that the substance is: 

(1) not harmful to human health or the environment;

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(2) necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

(3) consistent with organic crop production. 

For Comments That Do Not Support Substances Under Review: 

If you provide comments that do not support a substance on the National List, you should provide 

reasons why the use of the substance should no longer be allowed in organic production or handling. 

Specifically, comments that support the removal of a substance from the National List should 

provide new information since its last NOSB review to demonstrate that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with crop production. 

For Comments Addressing the Availability of Alternatives: 

Comments may present information about the viability of alternatives for a substance under sunset 

review. Viable alternatives include, but are not limited to:

o Alternative management practices that would eliminate the need for the specific 

substance; 

o Other currently exempted substances that are on the National List, which could 

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

Your comments should address whether any alternatives have a function and effect equivalent to or 

better than the allowed substance, and whether you want the substance to be allowed or removed from 

the National List. Assertions about alternative substances, except for those alternatives that already 

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. The following table can help you describe recommended 

alternatives in place of a current substance that you do not want to be continued.

Written public comments will be accepted through October 7, 2014 via www.regulations.gov. 

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

 Page 103b of 104
Sunset 2016 Review Summary 

Meeting 1 - Request for Public Comment

Crops Substances

August 27, 2014 

SUNSET 2016: CROPS SUBSTANCES

Ferric phosphate Synthetic 

Use - As a synthetic substance allowed for use in organic crop production 

Listing: Ferric phosphate (CAS # 10045 - 86 - 0). As slug or snail bait

Technical Report: Ferric Phosphate 07/2004, Ferric Phosphate 6/2010, Supplemental TR 07/2012

Petition(s): Ferric Phosphate 5/01/03 

Petition to remove: 07/07/09

Past NOSB Actions: NOSB review and recommendation for addition to the National List 3/2005

Recommendation to renew: 04/2010

NOSB vote on motion for removal from the National List 10/2012

Regulatory Background: 

Proposed for addition to National List 9/16/05 70 FR 54660

Added to National List 09/11/06 71 FR 53299

Renewed 08/03/2011 76 FR 46595

Sunset Date: 9/12/2016

Reference: 7 CFR 205.601(h)

Additional information requested by NOSB 

The Crops Subcommittee has no additional questions 

Hydrogen chloride Synthetic 

Use - As a synthetic substance allowed for use in organic crop production 

Listing: Seed preparations. Hydrogen chloride (CAS # 7647 – 01 - 0) - for delinting cotton seed for 

planting.

Technical Report: Hydrogen Chloride 2003 TAP, 5/2014 Limited Scope TR

Petition(s): Hydrogen Chloride 10/30/02

Past NOSB Actions: NOSB review and recommendation for addition to the National List 05/2004

Recommendation to renew 11/2009

Regulatory Background: 

Proposed for addition to National List 9/16/05 70 FR 54660

Added to National List 09/11/06 71 FR 53299

Renewed 08/03/2011 76 FR 46595

Sunset Date: 9/12/2016

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Reference: 7 CFR 205.601(n)

Additional information requested by NOSB 

The Crops Subcommittee is interested in comments regarding: 

Hydrogen chloride is used in gaseous form to remove linters (fuzz) on cotton seeds that would interfere 

with the flow of seeds during planting. Acid delinting is the industry standard, and other acids, sulfuric 

acid for example, are sometimes used in non-organic applications. Hydrogen chloride needs extreme 

care when used, but it is not clear that suitable alternatives are sufficiently available for organic cotton 

growers.

The TR indicated that some research shows that novel mechanical delinting techniques may clean cotton 

seed while improving cotton lint yield in a research context. The Crops Subcommittee is interested in 

hearing from the organic community as to the relative efficacy of mechanical delinting techniques and 

whether these techniques are feasible and available in commercial scale organic cotton production. The 

Crops Subcommittee is also interested in hearing whether the NOSB can encourage safer methods of 

delinting seeds.

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