National Organic Standards Board 

Materials/GMO Subcommittee Discussion Document

Excluded Methods Determinations Spring 2021

February 12, 2021 

Introduction and background 

Organic originators, stakeholders, producers, consumers, and many iterations of the NOSB have 

operated under the consensus that, at its foundation, the USDA’s National Organic Program (NOP) 

requires food labeled as organic to be produced without the use of genetic manipulation. Developments 

in biotechnology continue to spread across the food system, touching all points of the supply chain. To 

address these changes, the NOSB is working to examine, track, and define excluded methods as part of 

the effort to maintain the mandates of the USDA’s organic regulations. 

Until the US Food and Drug Administration (FDA) & the US Department of Agriculture (USDA) provide 

transparency in the effort to track and inform the public on the presence of genetic engineering in the 

food system, the NOSB will engage expertise from the community at large, to maintain a foundational 

principle of organic: that GMOs are a transgression on the integrity of the entire organic supply chain 

from cell to table. As stakeholders in the democracy of food and agriculture, this discussion document 

seeks to articulate current understanding, while expanding the communities’ tools for protecting the 

integrity of the organic label from excluded methods.

Goals of this document 

This discussion document continues the work of identifying emerging technologies in the food sector 

and determining whether they will be considered excluded methods in the organic system. At the same 

time, this document seeks to re-establish the community’s understanding of the rapidly expanding 

presence of biotechnology directly in the food system and transiently as technology is being applied 

farther and farther up the supply chain. 

The Materials Subcommittee recognizes the topic of genetic engineering and evaluation of excluded 

methods will remain on our work agenda. It is recognized that additional criteria may become necessary 

as the field of genetic manipulation expands. As a process based regulatory framework, organic does not 

rely only on testing to determine the presence of prohibited materials. The community consensus 

recognizes that awareness of emerging technologies along with a well-educated community of 

producers, inspectors, NOSB members, and regulators, is currently, the most efficient and reliable path 

to protecting organic as a food sector that prohibits the breaching of the integrity of the genome.

Definitions and Criteria

Under the NOP organic regulations, methods that employ genetic engineering techniques are excluded 

from use in organic production. The current regulation defines an excluded method at §205.2 Terms 

defined:

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, 

NOSB Proposals and Discussion Documents April 2021 155 of 172
microencapsulation and macroencapsulation, and recombinant DNA technology (including gene 

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

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

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

Below are the criteria listed in the 2016 (Appendix A), 2017, 2018 and 2019 NOSB recommendations to 

determine if methods should be excluded.

1. The genome is respected as an indivisible entity, and technical/physical insertion, deletions, or 

rearrangements in the genome is refrained from (e.g. through transmission of isolated DNA, RNA, 

or proteins). In vitro nucleic acid techniques are considered to be an invasion into the plant 

genome.

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

genetic use restriction technologies are refrained from (e.g. Terminator technology).

3. Novel proteins and other molecules produced from modern biotechnology must be prevented 

from being introduced into the agro-ecosystem and into the organic food supply.

4. The exchange of genetic resources is encouraged. In order to ensure farmers have a legal avenue 

to save seed and plant breeders have access to germplasm for research and developing new 

varieties, the application of restrictive intellectual property protection (e.g., utility patents and 

licensing agreements that restrict such uses to living organisms, their metabolites, gene 

sequences, or breeding processes) are refrained from.

The NOSB has voted on the following and determined them to be excluded methods:

Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

Targeted genetic 

modification (TagMo) 

syn.

Synthetic gene

technologies syn.

Genome engineering

syn.

Gene editing syn.

Gene targeting

Sequence-specific nucleases 

(SSNs)

Meganucleases Zinc finger 

nuclease (ZFN) 

Mutagenesis via

Oligonucleotides 

CRISPR-Cas system (Clustered 

regularly interspaced short 

palindromic repeats) and 

associated protein genes TALENs 

(Transcription activator-like 

effector nucleases)

Oligonucleotide directed 

mutagenesis 

(ODM) Rapid Trait Development 

System

YES 1, 3, 4 Most of these new 

techniques are not 

regulated by USDA and are 

currently difficult to

determine through testing.

NOSB Proposals and Discussion Documents April 2021 156 of 172
Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

Gene Silencing RNA-dependent DNA

methylation (RdDM) Silencing 

via RNAi pathway RNAi 

pesticides 

YES 1, 2, 4 

Accelerated plant 

breeding techniques 

Reverse Breeding 

Genome Elimination 

FasTrack 

Fast flowering 

YES 1, 2, 4 These may pose an

enforcement problem for 

organics because they are 

not detectable in tests. 

Synthetic Biology Creating new DNA sequences 

Synthetic chromosomes 

Engineered biological functions 

and systems 

YES 1, 3, 4 

Cloned animals and 

offspring 

Somatic nuclear transfer YES 1, 3 

Plastid 

transformation 

YES 1, 3, 4 

Cisgenesis The gene modification of a 

recipient plant with a natural 

gene from a crossable-sexually 

compatible-plant. The 

introduced gene includes its 

introns and is flanked by its 

native promoter and terminator 

in the normal-sense orientation. 

YES 1, 3, 4 Even though the genetic 

manipulation may be within 

the same species; this 

method of gene insertion 

can create characteristics 

that are not possible within 

that individual with natural 

processes and can have 

unintended consequences. 

Intragenesis The full or partial coding of DNA 

sequences of genes originating 

from the sexually compatible 

gene pool of the recipient plant 

and arranged in sense or 

antisense orientation. In 

addition, the promoter, spacer, 

and terminator may originate 

from a sexually compatible gene 

pool of the recipient plant. 

YES 1, 3, 4 Even though the genetic 

manipulation may be within 

the same species, this 

method of gene 

rearrangement can create 

characteristics that are not 

possible within that 

individual with natural 

processes and can have 

unintended consequences. 

NOSB Proposals and Discussion Documents April 2021 157 of 172
Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

Agro-infiltration YES 1, 3, 4 In vitro nucleic acids are 

introduced to plant leaves to 

be infiltrated into them. The 

resulting plants could not 

have been achieved through 

natural processes and are a 

manipulation of the genetic 

code within the nucleus of 

the organism. 

TransposonsDeveloped via use of 

in vitro nucleic acid 

techniques 

 YES 1,3,4 Does not include 

transposons developed 

through environmental 

stress such as heat, drought 

or cold. 

Induced Mutagenesis YES 1 Developed through in vitro 

nucleic acid techniques

does not include 

mutagenesis developed 

through exposure to UV 

light, chemicals, irradiation, 

or other stress-causing 

activities.

 

The following genetic engineering methods were found by the NOSB NOT to be excluded methods: 

 

Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

Marker Assisted

Selection 

NO 

Transduction NO 

Embryo rescue in 

plants 

NO IFOAM’s 2018 position 

paper on Techniques in 

Organic Systems considers 

this technique compatible 

with organic systems. 

Embryo transfer, or 

embryo rescue, in 

animals

NO *use of hormones not 

allowed in recipient 

animals. 

Transposons NO Developed through 

environmental stress, such 

as heat, drought, or cold. 

NOSB Proposals and Discussion Documents April 2021 158 of 172
The following TBD methods will continue to be researched in future NOSB proposals: 

Terminology

Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Used 

Notes 

Protoplast Fusion TBD There are many ways to 

achieve protoplast fusion, 

and until the criteria about 

cell wall integrity are 

discussed and developed, 

these technologies cannot 

yet be evaluated.

Cell Fusion within 

Plant Family 

TBD Subject of an NOP memo in 

2013. The Crops 

Subcommittee will 

continue to explore the 

issue. 

TILLING Eco-TILLING TBD Stands for “Targeted 

Induced Local Lesions In 

Genomes.” It is a type of 

mutagenesis.

Doubled Haploid 

Technology (DHT) 

TBD There are several waysto 

make double haploids, 

and some do not involve 

genetic engineering while 

some do. It is difficult or 

impossible to detect DHT 

with tests. 

Induced 

Mutagenesis 

TBD Induced mutagenesis 

developed through 

exposure to UV light, 

chemicals, irradiation or 

other stress.

Transposons TBD Produced from chemicals, 

ultraviolet radiation, or 

other synthetic activities.

NOSB Proposals and Discussion Documents April 2021 159 of 172
Discussion 

The NOSB is seeking answers to the following questions to aid in creating guidance and/or regulation on 

excluded methods. 

Questions

1. What new emerging methods in biotech should be added to the TBD list? Please also describe the 

primary purpose and how far from commercialization for use in food processing and/or 

agriculture the method is in its development.

2. Please prioritize the remaining TBD list methods according to the definitions, principles and 

criteria established in the 2016 Proposal (see Appendix A)

a. Would methods newly determined to be excluded by the NOSB/NOP be retroactive for 

commercial varieties already in the marketplace?

b. Should the NOSB grandfather in methods that have long been used in organic plant 

breeding (e.g., double haploids) and focus its energy entirely on new and emerging 

technologies? 

c. How do we regulate technologies used to develop new seed varieties that companies are 

otherwise under no obligation to disclose?

3. Are unintentional excluded methods hiding in organic systems when the actual material produced

and used has no trace of excluded method in the final organic product? Do we have the 

inspection, testing, and enforcement tools to keep prohibited methods out of the organic 

marketplace? 

4. Given the lack of transparency around emerging technology entering food and agricultural 

systems, how can Organic producers, handlers, certifiers, and this Board, etc. stay educated on 

emerging methods and the potential for contamination?

Subcommittee Vote: 

Motion to accept the discussion document on Excluded Methods

Motion by: Mindee Jeffery

Seconded by: Brian Caldwell

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

 

Approved by Wood Turner, Materials Subcommittee Chair, to transmit to NOSB, February 12, 2021

NOSB Proposals and Discussion Documents April 2021 160 of 172
Appendix A 

Formal Recommendation 

From: National Organic Standards Board (NOSB) To: the 

National Organic Program (NOP) 

Date: November 18, 2016

Subject: Excluded Methods Terminology Recommendation 

NOSB Chair: Tracy Favre 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: X 

Other: 

Statement of the Recommendation: 

The NOSB Materials/GMO subcommittee approves the three sections of this proposal: 

1. Approve the definitions of Genetic Engineering (GE), Genetically Modified Organism (GMO), 

Modern Biotechnology, Synthetic Biology, Non-GMO, and Classical/Traditional Plant Breeding as 

written above. 

2. Approve the Principles and Criteria above that will be used in the evaluation of new 

technologies and terminologies. 

3. Adopt the Terminology chart proposed above and the listings in it as presented, with the 

removal of the Dupont Seed Production Technology term, recognizing that this will be added to 

as further deliberations occur in the future. 

Rationale Supporting Recommendation (including consistency with OFPA and Organic Regulations): 

Excluded Methods are prohibited in the USDA organic regulations, but the definition in the 

regulation that was adopted in 1995 needs updating in light of new technologies and processes. The 

NOSB recommends that this set of supplemental definitions, criteria for review of new technologies, 

and terms that are included in the definition of excluded methods, be addressed in guidance on 

interpreting the excluded methods provision in the regulations. 

NOSB Proposals and Discussion Documents April 2021 161 of 172
NOSB Vote: 

Motion by: Zea Sonnabend 

Seconded by: Emily Oakley | 

Yes: 14 No: 0 Abstain: 0 Absent: 1 Recuse: 0 

 Motion Passed 

National Organic Standards Board 

Materials/GMO Subcommittee Proposal 

Excluded Methods Terminology 

August 30, 2016 

 

Introduction and Background 

In April 2013 the project was started to grapple with the definition of "excluded methods" in the USDA 

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

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

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

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

microencapsulation and macroencapsulation, and recombinant DNA technology (including gene 

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

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

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

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

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

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

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

and enzymes. However, this definition needs re-examination and updating due to rapid advances in 

recombinant DNA biotechnology since 1995 that have resulted in gray areas for the organic standards 

regarding interpretation and enforcement. 

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

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

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

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

therefore be genetically engineered. The current definition is inadequate to clarify these issues. In the 

last few years the rise of gene editing with no insertion of foreign DNA, synthetic biology, and the 

genetically engineered insects that are starting to appear make this effort even more important. 

The first NOSB Discussion Document on excluded methods in 2013,1 discussed each of the terms in the 

above definition, defined and discussed other terms involved in traditional breeding, such as 

NOSB Proposals and Discussion Documents April 2021 162 of 172
mutagenesis and conjugation, and brought up new terms that may be considered to be genetic 

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

The discussion questions posed asked commenters to suggest principles on which to base GE 

distinctions, to offer opinions on what terms were and were not excluded methods, and to bring 

forward new terms that may need consideration. 

The second NOSB discussion document posted in September 2014 and in April 20152 analyzed the 

comments received and proposed several options for an updated definition, and principles and criteria 

to use when evaluating the various genetic modification issues. Additional terms were collected and the 

beginnings of some definitions were started. A structure was proposed similar to the one in use by the 

Research Institute of Organic Agriculture (FiBL) in Europe that involves an itemized chart with a yes/no 

column where the specific techniques could be itemized and evaluated. The Subcommittee made an 

informal recommendation, which was not voted upon, that these revisions to the definition and 

structure for evaluating techniques be regulated through NOP guidance rather than additional 

rulemaking. Lastly it was acknowledged that there will be some unresolved issues that will need 

continued public discussion because they pose enforcement challenges, are totally hidden from view, or 

not enough is known about them yet. 

Both a proposal and a discussion document were posted for the April 2016 NOSB meeting. While 

comment regarding the approach was generally favorable, there clearly was a need for some refinement 

of the definitions and criteria. There was also confusion about which techniques were part of the 

proposal and which remained to be discussed further. 

Goals of This Proposal/Document 

The need for forward motion on this subject is more pressing every month. The fact that over 1000 

pages of scientific references were submitted in public comment, with most of it consisting of research 

published since the NOSB GMO ad hoc Subcommittee was formed in 2012, indicates that the biotech 

community is rapidly outpacing any regulatory structure. The U.S. Department of Agriculture (USDA) 

has already ruled that certain plants produced with novel approaches to genetic manipulation will not 

be regulated in the United States 3 as genetically modified organisms. It is more imperative than ever 

that the organic community be very clear about where the line is drawn regarding genetic engineering. 

Public Comment from the past two and a half years has indicated strong support for this effort on the 

whole, although there is not consensus on some details. Every organic stakeholder is clear that genetic 

engineering is an imminent threat to organic integrity. The NOSB must make, to the extent it can, every 

effort to protect that integrity. 

The Materials Subcommittee is putting forth a structure for reviewing new technologies, and 

disseminating the results of the review in a transparent manner. To this end, the proposal portion of 

this document includes supplements to the definition in the rule based on internationally accepted 

language, criteria to use in the reviews based on that definition, and a chart of those techniques that 

are clearly "excluded methods" based on the definition and criteria. 

A separate discussion document contains the technologies, terms, and issues that the NOSB has not 

been able to agree on or on which it does not yet have enough information, or that pose challenges 

that have not yet been addressed. These items are put forth for discussion to collect further public 

NOSB Proposals and Discussion Documents April 2021 163 of 172
comment and will be reviewed at future NOSB meetings. 

Definitions 

In the previous discussion document, the NOSB suggested a couple of possible definitions that would 

update the text in the rule to be more comprehensive and be flexible enough to accommodate future 

technologies and terms. The Board favors the definitions in use by Codex Alimentarius that were also in 

the Cartagena Protocol. 

During the course of public comment and subsequent discussion, it has become clear that more than 

one definition is important to the organic community, but that all the terms the NOSB suggests defining 

here would fall under the Excluded Methods definition in the rule and would not change, but would 

strengthen that definition. These definitions are to be used in guidance to supplement and update the 

definition in the regulations, while leaving the rule itself intact. It is important to adopt some definitions 

that are widely accepted internationally and thus provide common ground with other countries who 

are concerned about GMOs in organics. 

Based on public comment on the Spring 2016 proposal, we decided to add a definition for 

classical/traditional plant breeding. Traditional breeding is a term used in the Excluded Methods 

definition in the rule and is therefore important to clarify. . However, because the other definitions and 

criteria are not unique to plants, we slightly changed the wording so that they are applicable to all 

organisms. 

In October 2015 the International Federation of Organic Agriculture Movements (IFOAM) published a 

Discussion Paper on a proposed revision to their Position on Genetic Engineering.45 Since other 

countries do not use the concept of "Excluded Methods",, IFOAM proposed new definitions for three 

terms: Genetic Engineering (GE), Genetically Modified Organism (GMO), and Synthetic Biology. After 

examining their definitions, the Materials/GMO Subcommittee (MS) agrees that these three terms are 

important to define in the guidance it are proposing. However, we do not wish to use the old approach 

(that IFOAM is still using) of trying to capture all the methods and terms into one definition, in because

it will be out of date as soon as the next round of new technologies arrives. 

Instead we are proposing that the following definitions of terms and acronyms, with sources, be 

adopted by the NOSB as Excluded Methods1

: 

Genetic engineering (GE) – A set of techniques from modern biotechnology (such as altered and/or 

recombinant DNA and RNA) by which the genetic material of plants, animals, organisms, cells and other 

biological units are altered and recombined. (First sentence modified from IFOAM Position cited above) 

Genetically Modified Organism (GMO) – A plant, animal, or organism that is from genetic engineering 

as defined here. This term will also apply to products and derivatives from genetically engineered 

sources. (Modified slightly from IFOAM Position cited above) 

Modern Biotechnology – (i) in vitro nucleic acid techniques, including recombinant DNA and direct 

injection of nucleic acid into cells or organelles, or (ii) fusion of cells beyond the taxonomic family, that 

overcomes natural, physiological reproductive or recombination barriers, and that are not techniques 

used in traditional breeding and selection. (From Codex Alimentarius6

) 

NOSB Proposals and Discussion Documents April 2021 164 of 172
Synthetic Biology7

 – A further development and new dimension of modern biotechnology that 

combines science, technology and engineering to facilitate and accelerate the design, redesign, 

manufacture and/or modification of genetic materials, living organisms and biological systems. 

(Operational Definition developed by the Ad Hoc Technical Expert Group on Synthetic Biology of the UN 

Convention on Biological Diversity8

) 

Non-GMO – The term used to describe or label a product that was produced without any of the 

excluded methods defined in the organic regulations and corresponding NOP policy. The term "nonGMO" is consistent with process-based standards of the NOP where preventive practices and 

procedures are in place to prevent GMO contamination while recognizing the possibility of inadvertent 

presence. (Modified based on public comment from Spring 2016 NOSB) 

1 Both definitions and criteria were worked on in between the Spring and Fall NOSB meetings by an ad 

hoc group with the following members: Julie Dawson, University of Wisconsin; David Gould, 

International Federation of Organic Agriculture Movements (IFOAM); Michael Hansen, Consumers 

Reports; Jaydee Hanson, Center for Food Safety; Kristina 

Hubbard, Organic Seed Alliance; Melody Meyer, United Natural Foods; James Myers, Oregon State 

University; Dana 

Perls, Friends of the Earth; Erica Renaud, Vitalis Organic Seeds; Dan Seitz, National Organic Standards 

Board (NOSB); Michael Sligh, Rural Advancement Fund International; Zea Sonnabend, Fruitilicious Farm 

and NOSB; Jim thomas, ETC Group; William Tracy, University of Wisconsin; Gwendolyn Wyard, Organic 

Trade Association. 

 

Classical/Traditional plant breeding – Classical (also known as traditional) plant breeding relies on 

phenotypic selection, field based testing and statistical methods for developing varieties or identifying 

superior individuals from a population, rather than on techniques of modern biotechnology. The steps 

to conduct breeding include: generation of genetic variability in plant populations for traits of interest 

through controlled crossing (or starting with genetically diverse populations), phenotypic selection 

among genetically distinct individuals for traits of interest, and stabilization of selected individuals to 

form a unique and recognizable cultivar. Classical plant breeding does not exclude the use of genetic or 

genomic information to more accurately assess phenotypes, however the emphasis must be on whole 

plant selection. 

This series of definitions provides a better framework than the existing definition, as it elaborates the 

various technologies that would be prohibited as well as those which would be allowed. We propose to 

combine these definitions, the principles and criteria discussed below, and the terminology chart 

presented into this proposal for guidance on excluded methods. 

Principles and Criteria 

The NOSB has its own set of Principles of Organic Production and Handling in its Policy and Procedures 

Manual9

. The principles start with: 

1.1 Organic agriculture is an ecological production management system that promotes and 

enhances biodiversity, biological cycles, and soil biological activity. It emphasizes the use of 

management practices in preference to the use of off-farm inputs, taking into account that 

NOSB Proposals and Discussion Documents April 2021 165 of 172
regional conditions require locally adapted systems. These goals are met, where possible, 

through the use of cultural, biological, and mechanical methods, as opposed to using synthetic 

materials to fulfill specific functions within the system. 

Regarding Genetic Engineering: 

1.11 Genetic engineering (recombinant and technology) is a synthetic process designed to 

control nature at the molecular level, with the potential for unforeseen consequences. As such, 

it is not compatible with the principles of organic agriculture (either production or handling). 

Genetically engineered/modified organisms (geo/gmos) and products produced by or through 

the use of genetic engineering are prohibited. 

The following principals of Organic Agriculture are used by IFOAM10 and summarize well the guidance 

for developing a position on GMO technology. 

• Principle of Health: Organic Agriculture should sustain and enhance the health of soil, plant, 

animal, human and planet as one and indivisible. 

• Principle of Ecology: Organic Agriculture should be based on living ecological systems and 

cycles, work with them, emulate them and help sustain them. 

• Principle of Fairness: Organic Agriculture should build on relationships that ensure fairness with 

regard to the common environment and life opportunities. 

• Principle of Care: Organic Agriculture should be managed in a precautionary and responsible 

manner to protect the health and well-being of current and future generations and the 

environment. 

 

Using the principles above, biotechnology processes will be reviewed to the following criteria to 

determine if they are excluded methods: 

 

1. The genome is respected as an indivisible entity and technical/physical insertion, deletions, or 

rearrangements in the genome is refrained from (e.g. through transmission of isolated DNA, 

RNA, or proteins). In vitro nucleic acid techniques are considered to be invasion into the plant 

genome. 

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

use restriction technologies are refrained from (e.g. Terminator technology).11 

3. Novel proteins and other molecules produced from modern biotechnology must be prevented 

from being introduced into the agro-ecosystem and into the organic food supply. 

4. The exchange of genetic resources is encouraged. In order to ensure farmers have a legal avenue 

to save seed and plant breeders have access to germplasm for research and developing new 

varieties, the application of restrictive intellectual property protection (e.g., utility patents and 

licensing agreements that restrict such uses to living organisms, their metabolites, gene 

sequences or breeding processes are refrained from.12 

 

NOSB Proposals and Discussion Documents April 2021 166 of 172
Most of the techniques that are considered to be genetic engineering are clearly not compatible with 

the principal of ecology because they do not work within living ecological systems or sustain them. They 

are also at odds with the Principal of Fairness because they are not available equally to all stakeholders 

and are often patented or used to create patented traits. There are significant questions around the 

Principle of care for the health and well-being of future generations and the environment. These 

concerns do not change just because a technique cannot be tested for or does not use DNA foreign to 

the target organism. 

 

The secondary effects from the use of GMOs are starting to emerge clearly in parallel with the new 

technologies. Issues such as reduction in diversity on farms where GMOs are grown, the demise of 

beneficial species both above and below the soil, the decline in soil fertility and resilience from 

increased use of herbicides, the evolution of weeds resistant to those herbicides, the altered nutritional 

profiles of the GMO crop products, and the displacement of small farmers from their land are all 

violations of the principals of organic agriculture.13 

 

Process and Product 

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

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

definition. However, this is not currently how U.S. government agencies regulate GMOs14, or handle 

other issues such as pesticide residues or water quality standards. 

Newer technologies, known as Targeted genetic modification (TagMo) or targeted genome editing, are 

emerging and being adopted quickly.15 These are very clearly genetic engineering techniques but are not 

regulated by the current government structure because they do not involve DNA from a "pest" under 

the USDA APHIS regulatory structure. Many of these techniques involve precise changes in existing DNA 

without using foreign DNA from a different species. These new technologies make genetic modification 

much more accessible and less expensive. The resulting plants may not show up as genetically 

engineered in the commonly used testing methods because they contain no foreign DNA, just native 

DNA that has been changed at the allele level by humans. 

Forward Movement towards Structure 

FiBL Research Institute for Organic Agriculture from Switzerland submitted a comment in 2013 that 

included a chart that describes methods with a yes/no column for compatibility with organic standards 

for both plants and animals16. The NOSB posed adopting such a chart on the methods that receive 

consensus and can be incorporated into guidance. It is important to identify all these terms so that it is 

clear that they fall under the definition of excluded methods, but these terms do not need to be added 

to the definition itself. 

The first version of such a chart for the NOSB is presented here. Appendix A provides a brief description 

of each term with additional citations for those who want to find out more about the terms. There is so 

much terminology and so many techniques with similar or multiple names that we have added a 

column for additional names and types used for each general process. Along with lack of regulation of 

some of these processes, there is lack of standardization of the terms, so that new names and 

sometime proprietary ones are emerging all the time. 

NOSB Proposals and Discussion Documents April 2021 167 of 172
We would especially like to acknowledge the work done by the Center for Food Safety in their public 

comment for the April 2015 meeting. They have helped organize all the various terminology and 

provided substantial scientific papers that discuss all the terms.17 The technologies are grouped by the 

tasks that the methods accomplish and the types of changes made to the engineered organism. In the 

context of this proposal we are not able to discuss most of the terms at length so please see the 

Appendix and the CFS cited comment for the full reference list. 

For this version of the proposal, the ones that were marked "TBD" in the previous chart below are now 

moved to the accompanying Discussion Document. The ones presented here are those that we are 

voting on as either Excluded or Allowed. A column has been added for which criteria apply to the 

excluded techniques that have led to our conclusion to exclude them. 

 

Terminology Chart 

Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

Targeted genetic 

modification (TagMo) 

syn. Synthetic 

gene technologies 

syn. Genome 

engineering 

syn. Gene editing 

syn. Gene 

targeting 

Sequence-specific nucleases 

(SSNs) Meganucleases 

Zinc finger nuclease (ZFN) 

Mutagenesis via 

oligonucleotides 

CRISPR-Cas 

system* TALENs** 

Oligonucleotide directed 

mutagenesis (ODM) 

Rapid Trait Development 

System (RTDS) (Cibus) 

YES 1, 3, 4 Most of these new 

techniques are not 

regulated by USDA and 

are hard to test for. 

Gene Silencing 

 

RNA-dependent DNA 

methylation (RdDM) 

Silencing via RNAi pathway 

RNAi pesticides 

YES 1, 2, 4 

Accelerated plant 

breeding techniques 

 

Reverse Breeding 

Genome Elimination 

FasTrack 

Fast flowering 

Dupont Seed Production 

Technology (SPT)

YES 1, 2, 4 These may pose an 

enforcement problem 

for organics because 

they are not detectable 

in tests. 

Synthetic Biology Creating new DNA sequences 

Synthetic chromosomes 

Engineered biological 

functions and systems. 

YES 1, 3, 4 

Cloned animals and 

offspring 

Somatic nuclear transfer YES 1, 3 

NOSB Proposals and Discussion Documents April 2021 168 of 172
Terminology Chart 

Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

Plastid 

Transformation 

YES 1, 3, 4 

Marker Assisted 

Selection 

NO 

Transduction NO 

* CRISPR-Cas = Clustered regularly interspaced short palindromic repeats and associated protein genes. 

** TALENs = Transcription activator-like effector nucleases. 

Proposal 

This proposal has three sections, to be used in NOP guidance on excluded methods: 

1. Approve the definitions of Genetic Engineering (GE), Genetically Modified Organism (GMO), Modern 

Biotechnology, Synthetic Biology, Non-GMO, and Classical/Traditional Plant Breeding as written above. 

2. Approve the Principles and Criteria above that will be used in the evaluation of new technologies 

and terminologies. 

3. Adopt the terminology chart proposed above and the listings in it as presented, recognizing that this 

will be added to as further deliberations occur in the future. 

 

Subcommittee Vote Motion to accept the three sections of this proposal as stated above. Motion by: 

Zea Sonnabend 

Second: Emily Oakley 

Yes: 4 No: 0 Absent: 1 Abstain: 1 Recuse: 0 

 

Appendix A – 

Brief Description and Additional Citations for Terms used in Excluded Methods Terminology Chart. 

Only terms that are marked YES or NO as Excluded Methods are defined here. All those marked TBD are 

still being worked on in discussion. Those marked "syn." are defined in cited reference from Center for 

Food Safety Public Comment in April 201518. Some other definitions are from the NOSB previous 

discussion document19 and from the FiBL 2015 plant breeding dossier.20 

 

Targeted genetic modification (TaqMo) (Kuzma and Kokotovich 2011, Kokotovich and Kuzma 2014) - a 

collective term for the zinc finger nuclease techniques that create DNA double-stranded breaks at 

specific genomic locations that can then be used to alter the target gene. The genetic 

NOSB Proposals and Discussion Documents April 2021 169 of 172
modification would not necessarily involve transfer of nucleic acids from another species, nor 

would it be easy to detect in a final product. 

• syn. Synthetic gene technologies (Then 2015) 

• syn. Genome engineering (Voytas and Gao 2014) 

• syn. Gene editing (Puchta and Fauser 2013) 

• syn. Gene targeting (GT) (Puchta and Fauser 2013, Endo et al. 2015) 

• syn. Sequence-specific nucleases (SSNs) (Voytas and Gao 2014): 

• syn. Meganucleases (Gao et al. 2011, as cited in FSANZ 2013) 

• syn. Site directed mutagenesis via oligonucleotides, zinc finger nuclease (ZFN) (Dow, APHIS 

2012) - an introduction of recombinant DNA through transient molecules that are identified 

by zinc-finger nucleases, with or without a repair template. The techniques resemble 

transgenesis but the end products are similar to, and indistinguishable from, conventionally 

bred plants. 

• syn. Clustered regularly interspaced short palindromic repeats and associated protein genes 

(CRISPR-Cas system) (NYTs 3/20/2015) – a protein called Cas9 enables breaks in DNA at 

specific spots so that additional pieces of DNA and RNA can be inserted. 

• syn. Transcription activator-like effector nucleases (TALENs) (Sprink et al. 2014). 

• syn. Oligonucleotide directed mutagenesis (ODM) (Lusser et al. 2011) 

• syn. Cibus Rapid Trait Development System (RTDS) (Beetham et al. 2012 patent) - Similar to 

the oligonucleotide targeted DNA modification it does not leave behind transgenic material, 

only uses it to create a change in a precise area of a gene. 

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

through inserting methyl groups onto RNA and DNA that then suppress the expression of the 

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

breeding. 

• syn. RNA-dependent DNA methylation (RdDM) (Lusser et al. 2011) 

• syn. Gene silencing via RNAi pathway (Casacuberta et al. 2015, Baier et al. 2014, Lubasik 

and Zielenkiewicz 2014, Hirschi 2012, Heinemann et al. 2013, Lundgren and Duan 2013, 

Wagner et al. 2015) – A technique in which a small strand of RNA is inserted into a DNA 

sequence to regulate the expression of the gene. There is no change to the DNA sequence,

but there is technical interference with the genome. 

• RNAi-based pesticides (Palli 2014, Zhu 2013) – RNA interference (RNAi) is a technique in 

which gene silencing RNA strands are inserted into a target genome in order to regulate the 

expression of target genes. It was used to engineer rootworm resistant corn as well as to 

genetically engineer insects themselves. 

Accelerated Plant Breeding Techniques 

• Reverse Breeding (Dirks et al. 2009) – A process that uses several other techniques such as 

RNAi to suppress meiotic recombination, tissue culture, and then double haploidization to 

create parental lines that are homozygous to use in breeding F1 hybrids. 

• Genome elimination (Comai 2014) 

NOSB Proposals and Discussion Documents April 2021 170 of 172
• FasTrack (Waltz 2012) – 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 non-transgenic varieties carrying desirable traits. Markers are 

used to identify the right traits and, at the end of the breeding program, only those are 

selected that do not have the transgene. 

• Fast flowering (Flachowsky et al. 2011) 

• DuPont’s Seed Production Technology (SPT) (Waltz 2012) 

Synthetic Biology (see definition in main document) 

• Synthetic chromosomes (Shenoy and Sarma 2010, pp. 12-13; Gaeta et al. 2012) 

Embryo Transfer in animals – a technique used in animal breeding. It involves inducing superovulation 

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

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

Plastid transformation (Maliga 2004, as cited in NOSB discussion 2014) – Plastids are semi-autonomous 

organelles within higher plants with a small, highly polyploid genome. Technology has been 

developed for genetic modification of this genome independent of nuclear DNA. Currently used 

commercially in tobacco, and widely researched. 

Marker Assisted Selection – Molecular markers are used as diagnostic aids to determine differences in 

the DNA sequence. They can help in selecting desired traits. The markers do not change the 

DNA of living plants and are not considered to be genetic engineering. 

 

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

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

2 National Organic Standards Board Materials/GMO Subcommittee. (2014). Discussion Document on 

Excluded Methods Terminology. August 22. 

3 Waltz, E. (2012). Tiptoeing around transgenics. Nature Biotechnology, 30, 215-217. 

doi:10.1038/nbt.2143 

4 IFOAM – Organics International, 2015, 2015 Discussion Paper on a Proposed Revision to Position on 

Genetic Engineering and Genetically Modified Organisms in Organic Agriculture. 

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/Discussion_paper_on_GMO_positio

n_2015.pdf 5 IFOAM – Organics International, 2002, Postition on Genetic Engineering and Genetically 

Modified Organisms, P01, 

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/IFOAM_GMO_Position_Paper.p

df 6 Codex Alimentarius Commission (2003). “Principles for the Risk Analysis of Foods Derived from 

Modern Biotechnology,” CAC/GL 44>2003. Amended 2008, 2011, available at:

http://www.fao.org/faoDwhoD codexalimentarius/shD 

proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FSt

andar ds%252FCAC%2BGL%2B44D2003%252FCXG_044e.pdf. 7 Two other definitions were looked at when this one was chosen: Synthetic Biology – Designing and 

constructing biological devices, biological systems, biological machines and biological organisms using 

a range of methods derived from molecular biology and biotechnology, including in virtually all cases 

NOSB Proposals and Discussion Documents April 2021 171 of 172
the techniques of genetic engineering or genetic modification. (From IFOAM Position cited above). 

Synthetic biology is a maturing scientific discipline that combines science and engineering in order to 

design and build novel biological functions and systems. This includes the design and construction of 

new biological parts, devices, and systems...as well as the re-design of existing, natural biological 

systems for useful purposes.” (from SynBerc, the University of California/Department of Energy 

synthetic biology research consortium) 8 Link to the European Commission's draft definition with discussion: 

http://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consulta

tion_21_en.ht m

9 NOSB Policy and Procedures Manual: https://www.ams.usda.gov/sites/default/files/media/NOSBPolicyManual.pdfhttps://www.ams.usda.gov/sites/default/files/media/NOSB-PolicyManual.pdf 

10 http://www.ifoam.bio/sites/default/files/poa_english_web.pdf 

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

0070 

12 FiBL Research Institute of Organic Agriculture 2015. Dossier No. 2 Plant Breeding Techniques: an 

assessment for organic farming. 

 

13 IFOAM – Organics International, 2015, 2015 Discussion Paper on a Proposed Revision to Position on 

Genetic Engineering and Genetically Modified Organisms in Organic Agriculture. 

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/Discussion_paper_on_GMO_positi

on_2015.pdf 14 Kuzma J, Kokotovich A (2011) Renegotiating GM crop regulation. EMBO reports 12: 

883–888. 15 Kokotovich A, Kuzma J (2014) Conflicting Futures: Environmental Regulation of Plant Targeted Genetic 

Modification. Bulletin of Science, Technology & Society 34: 108–120. 16 FiBL Research Institute of Organic Agriculture 2013. Public Comment to NOSB. Docket AMS-NOP-12-

0070 17 CFS Comments to the NOSB, 2015, Docket #AMS_NOP_15-0002-0874 

18 CFS Comments to the NOSB, 2015. Reference List. 

http://www.regulations.gov/#!documentDetail;D=AMS-NOP-15- 

0002-0875 19 National Organic Standards Board Materials/GMO Subcommittee. (2014). Discussion Document on 

Excluded Methods Terminology. August 22. 

20 FiBL Research Institute of Organic Agriculture 2015. Dossier No. 2 Plant Breeding Techniques: an 

assessment for organic farming. 

NOSB Proposals and Discussion Documents April 2021 172 of 172