National Organic Standards Board 

Materials/GMO Subcommittee Discussion Document 

Excluded Methods Determinations 

August 12, 2021 

Introduction and background 

Cell fusion and protoplast fusion have a nuanced history in the context of the USDA’s National Organic 

Program and the work of the National Organic Standards Board. Cell fusion is included under terms 

defined at §205.2 as an excluded method. In 2013, the NOP clarified its position on both techniques in 

Policy Memo 13-1 allowing for both techniques to be used solely within taxonomic plant families. As 

work by the NOSB progressed in this area, cell fusion and protoplast fusion continue to be included as 

techniques to be evaluated on the excluded methods “TBD list” with notes indicating follow-up work by 

the NOSB. 

Goals of this document 

The Materials Subcommittee is seeking feedback on the TBD list terms ‘cell fusion’ and ‘protoplast 

fusion.’ This document will outline the history and explore context towards determining if more 

discussion is necessary on the issues of cell fusion and protoplast fusion as excluded methods in organic 

systems. 

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, 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) 

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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) 

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: 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 assess phenotypes more accurately, 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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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 activatorlike 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 and 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 and 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. 

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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. 

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. 

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Doubled Haploid 

Technology (DHT) 

TBD There are several ways to 

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 

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 in organic systems which 

included protoplast fusion. Both were deemed 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 phenomenon and is therefore allowed. 

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). This “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.” The Materials 

Subcommittee is exploring whether its work is complete with cell/protoplast fusion, and by extension, 

the need for additional criteria to approach future TBD list determinations. 

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Questions for our Stakeholders 

1. Should the NOSB prioritize developing additional criteria for excluded methods determinations 

before continuing to work on the remaining TBD list techniques? 

2. Is Policy Memo 13-1 complete and applied consistently in organic systems, i.e., do cell fusion 

and protoplast fusion need to remain on the TBD list or can they be moved to the excluded 

method section with the notes that allowance is made for these techniques when employed 

within taxonomic plant families? 

3. As the NOSB makes excluded methods determinations on the remaining TBD list techniques, 

should this organic system include allowance for historical use and a time frame for phasing out 

excluded uses? 

Appendix 

National Organic Program (February 2013). 

Policy Memorandum Cell Fusion Techniques used in Seed Production. AMS.USDA.GOV 

https://www.ams.usda.gov/sites/default/files/media/NOP-PM-13-1-CellFusion.pdf 

National Organic Standards Board. Materials/GMO Proposals. (April 2013). 

Discussion Document on Excluded Methods Terminology. AMS.USDA.GOV 

https://www.ams.usda.gov/sites/default/files/media/GMOSCTrmnlgyExclddMthdsApril%202013.pdf 

National Organic Standards Board. Materials/GMO Proposals. (April 2016). 

Excluded Methods Terminology – Third Discussion Document. AMS.USDA.GOV 

https://www.ams.usda.gov/sites/default/files/media/MSDDExcludedMethodsApr2016.pdf 

National Organic Standards Board Materials/GMO Proposals. (April 2016). 

Excluded Methods Terminology – Proposal. AMS.USDA.GOV 

https://www.ams.usda.gov/sites/default/files/media/MSPrpslExcldMethTerminologyApr2016.pdf 

Motion to accept the Fall 2021 excluded methods discussion document 

Motion by: Mindee Jeffery 

Seconded by: Brian Caldwell 

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

Approved by Wood Turner, Materials Subcommittee Chair, to transmit to NOP August 12, 2021. 

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