National Organic Standards Board

Materials/GMO Subcommittee

Excluded Methods Determinations Proposal Spring 2022

February 8, 2022

Introduction and background

At the November 18, 2016, in-person National Organic Standards Board (NOSB) meeting, the NOSB 

recommended that the National Organic Program (NOP) develop a formal guidance document for the 

determination and listing of excluded methods. The 2016 recommendation, entitled “Excluded Methods 

Terminology,” clarifies excluded method definitions and criteria in response to the increasing diversity in 

the types of genetic manipulations performed on seed, livestock, and other biologically based resources 

used in agriculture. Genetic engineering is a rapidly expanding field in science. To be responsive to this 

rapid expansion, the NOSB will continue to list new methods for review and will determine over time if 

the methods are or are not acceptable in organic agriculture. In addition to the 2016 recommendation, a 

discussion document provided a “To Be Determined (TBD) list” of technologies needing further review 

to determine if they should be classified as excluded methods or not; this proposal continues the work 

established in 2016. The organic community, as well as the NOSB, has voiced a consistent, unanimous 

stance that direct manipulation of genes through in vitro nucleic acid techniques should be considered 

as excluded methods. 

Cell Fusion is listed specifically in the regulations under (7 CFR 205.2) under terms defined as an 

excluded method. In 2013, Policy Memo 13-1 clarified cell and protoplast fusion as mimicking natural 

phenomenon with the limiting factor of [use when the original cells are within the same taxonomic plant 

family. In the October 2021 NOSB meeting, the Board put forth a discussion document to clarify whether

cell and protoplast fusion are excluded methods when the techniques are employed within taxonomic 

plant families. Note that in recent years, protoplast fusion is the scientifically preferred term for cell 

fusion as used in plant breeding. This document will continue to distinguish them as is necessary for the 

purpose of clarity. 

Goals of this proposal/document

At the October 2021 NOSB meeting, a discussion document was presented for public comment for the 

two items covered in this proposal: cell fusion and protoplast fusion. This proposal addresses these two 

items which have remained on the TBD list, despite cell fusion’s appearance in terms defined, and the 

clarification in Policy Memo 13-1. This Proposal seeks to clarify the position of cell and protoplast fusion, 

taking into consideration all previous NOSB work on the topic and current public comments. 

Public comment at numerous NOSB meetings over the years continues to stress the view that 

technologies used to manipulate the genetic code in a manner that is outside traditional plant and 

animal breeding should remain prohibited in organic production. Among organic stakeholders, there is a 

strong belief that genetic engineering is a threat to the integrity of the organic label. Both organic 

producers and consumers reject the inclusion of genetic engineering in organic production. This 

document represents the continuing work of the NOSB to clarify which methods in the expanding field 

of genetic engineering can or cannot be used under the USDA organic seal.

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

methods will remain on our work agenda to determine if emerging technologies do or do not meet our 

current definitions. We may need to incorporate additional criteria to evaluate new and unique 

technologies as they become commercially available as potential inputs to organic supply chains.

The NOSB is aware that specific laboratory tests may not be available to detect the presence of excluded 

methods in organic systems and will continue to emphasize the power of this process based, systems 

approach to evaluating agriculture and food processing. Until such a time as higher regulatory 

authorities provide organic systems with definitions and transparency of methodologies organic systems 

view as prohibited, the Materials Subcommittee will continue to evaluate, define, and assist organic 

stakeholders in determining the presence of excluded methods in organic systems as they emerge. 

Definitions and Criteria

Under the National Organic Program organic regulations, methods that employ genetic engineering 

techniques are excluded from use in organic production. The current regulation (7 CFR 205.2 Terms 

defined) defines an excluded method as:

A variety of methods used to genetically modify organisms or influence their growth and development by 

means that are not possible under natural conditions or processes and are not considered compatible 

with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, 

and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, 

and changing the positions of genes when achieved by recombinant DNA technology). Such methods do 

not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, 

or tissue culture.

The NOSB previously recommended the use of the following definitions to determine whether or not a 

method should be/is excluded.

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.

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)

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 Alimentarius)

Synthetic Biology – 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 Diversity)

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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.

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 the following: 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.

Criteria 

Below are the criteria listed in the 2016, 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.

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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.

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; it can have 

unintended consequences. 

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Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Applied 

Notes 

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; it can have 

unintended consequences. 

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

introduced to plant leaves to 

be infiltrated into them. The 

resulting plants could not 

have been achieved through 

natural processes and are a 

manipulation of the genetic 

code within the nucleus of 

the organism. 

TransposonsDeveloped via use of 

in vitro nucleic acid 

techniques 

 YES 1,3,4 Does not include 

transposons developed 

through environmental 

stress such as heat, drought 

or cold. 

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.

Cell and Protoplast 

Fusion 

donor and/or recipient cells are 

outside taxonomic plant family; 

and/or recombinant DNA 

technology is employed

YES Terms 

Defined

205.2

See NOP 

Policy Memo 13-1.

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Methods Allowed:

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.

Cell and Protoplast 

Fusion 

Recipient and/or donor cells 

are within the same 

taxonomic plant family; must 

be achieved without 

recombinant DNA technology

NO NOP Policy Memo 13-1;

Definition of Modern 

Biotechnology

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TBD list:

Terminology

Method and 

synonyms 

Types Excluded 

Methods 

Criteria 

Used 

Notes 

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.

Discussion and Public Comment

Under the NOP organic regulation, cell fusion is, by definition, an excluded method at §205.2. In 2013, 

NOP Policy Memo 13-1 provided further context for the use of cell fusion which included protoplast 

fusion. Both were deemed by the Policy Memo to be excluded methods except when either technique 

was employed within taxonomic plant families. The Policy Memo defends this assertion that this limited 

use mimics natural phenomena and is therefore allowed. In response to the 2021 Discussion document 

on this subject, a stakeholder provided historical context that indicates the NOSB’s support for the Policy 

memo:

“At the time the policy memo 13-1 came out, the NOSB was just starting to work on Excluded methods 

and there was a lot of controversy over the memo. That has since died down, and the definition of 

“Modern Biotechnology” that was adopted in the 2016 recommendation essentially codifies the 

approach in that memo by citing the international definitions that allow it within plant families.”
Furthermore, in February 2013, the NOSB Discussion Document on Excluded Methods Terminology 

references the Policy Memo explaining “that cell fusion techniques are considered an ‘excluded method’ 

when the donor cells/protoplasts do not fall within the same taxonomic family. Cell fusion is also an 

‘excluded method’ when the donor or recipient organism is derived using techniques of recombinant 

DNA technology and techniques involving the direct introduction into the organism of hereditary 

materials prepared outside of the organism.”

As the NOSB continued its work around issues of Excluded Methods, both cell fusion and protoplast 

fusion were included on a list of techniques that needed consideration for allowance/prohibition (see 

Appendix for NOSB Proposal and Discussion Document April 2016). The TBD list included cell fusion with 

the note column giving the explanation “[s]ubject of an NOP memo in 2013. The Crops Subcommittee 

will continue to explore the issue.” Protoplast fusion was included in the TBD list with the note “[t]here 

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.”

In the Fall 2021 Discussion Document preceding this proposal, stakeholders were asked if additional 

criteria for excluded methods determinations are necessary before work on the remaining terms can be 

addressed as indicated in the TBD list notes. Stakeholders were also asked if Policy Memo 13-1 is 

complete and being applied consistently in organic systems. These questions were intended to establish 

whether the conversation around cell and protoplast fusion is complete or if more discussion is needed.

In response, except for consistent suggestions for an edit to the language of the first criteria for scientific 

accuracy, stakeholders expressed overwhelming support for the criteria developed for evaluating 

Excluded Methods as they stand. One commenter captured the tone of many with the following 

assertion: 

“We do not support or see a need for additional criteria for excluded methods determinations at this 

time. It is imperative to the integrity of the NOSB’s process that the same criteria be

applied to all methods that have been reviewed and those still under review by the NOSB.......[i]t is 

important to first recognize that cell fusion is already clearly listed as an excluded method

per the regulatory definition (7 CFR 205.2). What the NOP Policy Memo 13-1 deems an

allowable method is cell fusion and protoplast fusion within taxonomic plant families. “Cell

fusion and protoplast fusion within the same taxonomic family” should be moved to the list of

methods determined to NOT be excluded. This is consistent with Policy Memo 13-1 and clarifies

that this method – again, when employed within taxonomic families – is viewed as traditional

plant breeding and not genetic engineering.” 

Stakeholders were consistent in response to the Policy Memo 13-1, asserting that the regulatory 

definition in conjunction with the Policy memo provide necessary clarity. The subcommittee appreciates 

that public comments were united and practical. One commenter reflected: 

“....organic plant breeders, organic seed companies, organic growers, and organic certifiers find Policy 

Memo 13-1 remains an important touchstone for guiding their decisions. Upholding Policy Memo 13-1 is 

essential to the success of organic operations, especially when considering the extensive use of cell fusion 

and protoplast fusion within taxonomic plant families”

Additionally, an organic seed producer provided the following:

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“...Policy Memo 13-1 adequately defines the instances under which cell fusion and protoplast fusion can 

be used in organic and ties the logic directly to the first sentence of the Regulatory definition of an 

‘excluded method’ wherein methods which could be achieved in nature are compatible with organic 

production; also, the third sentence of the definition wherein traditional breeding and hybridization are 

listed allowable. 

We would prefer that these methods be moved to the *Excluded Methods -NO - List with a note that 

‘Except when used outside of taxonomic plant families’. If kept on the Excluded Methods -YES -list, with 

the note ‘Except when employed within taxonomic plant families’ we would then prefer that the above 

mentioned (*) of NO list also be honored in order to clearly define and underscore that certain usages of 

cell fusion and protoplast fusion, in cases within taxonomic plant families, are acceptable for on farm 

use. 

For the sake of discussion, we would further raise the idea of updating the Guidance table on Excluded 

Methods to be renamed Allowed Methods or similar positive prose.” 

The Materials Subcommittee did not see the need to address issues of phasing out the use of either cell 

or protoplast fusion at this time, for these specific techniques. The policy memo was established in 2013 

and public comment expressed overwhelming support for the forward motion of this proposal as a 

validation of long-standing NOP Policy and the will of previous NOSB decision making on excluded 

methods.

Subcommittee Vote:

Motion to accept the proposal on excluded methods determinations for cell and protoplast fusion. 

The NOSB recommends the NOP develop a formal Guidance document to include the above Definitions, 

Criteria, Excluded and Allowed Methods tables as developed by previous Board Proposals in 2016, with 

the addition of the following:

1. Cell Fusion

• The NOSB recommends the NOP add Cell Fusion to the table of Excluded Methods when 

the donor and the recipient cells are outside taxonomic plant families and/or when 

either is derived using techniques of recombinant DNA technology; with notes on the 

exception for use when donor and recipient cells are within the same taxonomic plant 

families. 

• The NOSB recommends that Cell Fusion be added to the table of Allowed Methods with 

notes limiting the use to when the donor and recipient cells are within taxonomic plant 

families, and neither are derived from techniques of recombinant DNA technology.

2. Protoplast Fusion

• The NOSB recommends the NOP add Protoplast Fusion to the table of Excluded 

Methods, when either the donor or the recipient cells are outside taxonomic plant 

families and/or when either is derived using techniques of recombinant DNA 

technology; with notes on the exception for use when donor and/or recipient cells are 

within the same taxonomic plant families. 

• The NOSB recommends that Protoplast Fusion be added to the table of Allowed 

Methods with notes limiting the use to when the donor and recipient cells are within 

NOSB Proposals and Discussion Documents April 2022 Page 73 of 152
taxonomic plant families, and neither are derived from techniques of recombinant DNA 

technology.

Subcommittee Vote:

Motion by: Mindee Jeffery

Second: Logan Petrey 

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

Approved by Wood Turner, Materials Subcommittee Chair, to transmit to NOSB February 15, 2022.

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