National Organic Standards Board 

Materials/GMO Subcommittee 

Excluded Methods Terminology – Third Discussion Document 

February 23, 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 is in need of reexamination and updating due to rapid advances in recombinant DNA biotechnology since 1995 

that have made for gray areas for the organic standards regarding interpretation and 

enforcement.

Please see the Excluded Methods Terminology Proposal from this same date for a full 

elaboration of the background and progress to this point.

This Discussion Document contains the technologies, terms, and issues that we have not been 

able to agree on or do not yet have enough information on or that pose challenges that we 

have not yet taken up. These items are put out for discussion to collect further public comment. 

They will be reviewed at future NOSB meetings.

Discussion 

There are several areas for future discussion and work on this subject:

• Additional criteria for evaluating technologies that need to be considered.

• How to detect those technologies that are excluded but may not provide detectable 

genetically engineered DNA when tested.

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• Enforcement of the excluded method provisions of the rule when they are not traceable 

and undetectable.

• Additional technologies and terms that may not be clearly prohibited as excluded 

methods.

• Whether the concepts adopted in the proposal should or could lead to Organic Plant 

Breeding standards and the regulation of the term "Organically Bred Variety (or 

Animal)"

Once the proposal section in the accompanying document is voted on the structure will be in 

place to continue looking at these issues. We are interested in input from the organic public on 

these issues and will continue to have a transparent process to keep excluded methods out of 

organic production.

A. Additional Criteria

In the 2015 publication on Plant Breeding from FiBLi

, the Research Institute for Organic 

Agriculture from Switzerland, there are several more criteria mentioned than we have adopted 

in our proposal. These include:

• 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 cyto-plast fusions).

• A variety must be usable for further crop improvement and seed propagation. This 

means that the breeders’ exemption and the farmers’ right are legally granted and 

patenting is refrained from, and that the crossing ability is not restricted by technical 

means (e.g. by using male sterility without the possibility of restoration).

• The creation of genetic diversity takes place within the plant specific crossing barriers 

through fusion of egg cell and pollen. Forced hybridization of somatic cells (e.g. through 

cell fusions) is refrained from.

B. Detection and testing

Many in the organic community have proposed that there be some testing of at-risk seeds and 

crops for the presence of GMOs and a threshold beyond which the crop could not be sold as 

organic. Consumers throughout the world clearly want to know if their food has been 

genetically engineered. These tests are reliable indicators of DNA that has had foreign 

components introduced at the genome level.

However, in the newer gene splicing and gene editing technologies there is no foreign DNA 

introduced. The DNA in the genes has been moved around, or sequences introduced from 

within the same genome that change the expression of certain traits. Many if not most of these 

methods are not detectable with the existing tests for GMOs. While it is likely that such testing 

may be developed in the future, it becomes very challenging for the National Organic Program 

(NOP) and Accredited Certifying Agents (ACA) to determine if any new variety was produced 

with one of the newer excluded technologies.

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Ideas for addressing this have included creating a website for plant varieties that are excluded, 

or some sort of affidavit system for ACAs to use for varieties known to be introduced from 

these methods. Any workable ideas for accomplishing a way to tell which varieties are excluded 

are welcome.

C. Enforcement

Hand in hand with the above detection issue is the question of how to enforce the exclusion of 

new technologies when they cannot be detected. Enforcement needs to be equal across all 

ACAs and there has to be adequate training for ACAs in how to recognize newer strains of 

GMOs and what to do about them. The same process that could be developed for detection 

could also tie into enforcement, but some creative approaches are needed for these issues 

since they are not being addressed by the USDA as a whole.

D. Additional technologies and terms

The chart presented in the Proposal document has a number of terms that are marked "TBD" in 

the Excluded Methods column. These are the ones that need further discussion to determine 

which of these should be added to the chart and which may not be appropriately deemed and 

excluded method. Some may be excluded for some uses but not others depending on exactly 

how the technique is carried out. They are repeated below, with a few notes:

Terminology Chart

Method and synonyms Types Excluded 

Methods

Notes

Protoplast Fusion TBD There are many ways to achieve

protoplast fusion and until the 

criteria about cell wall integrity is 

discussed, these technologies 

cannot yet be evaluated.

Cisgenesis TBD A very broad term that may need 

to be divided into some allowed 

and some excluded techniques.

Intragenesis TBD Similar to cisgenesis but gene 

sequences may be re-arranged.

Transposons TBD Used in animal vaccines. May be 

excluded in some situations but not 

others.

Transduction TBD Most sources think not excluded, 

but more study needed.

Cell Fusion within Plant Family TBD Subject of an NOP memo in 2013, 

the issue of detection of these 

varieties needs to be addressed 

before further policies can be 

adopted.

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Embryo rescue in plants TBD Many sources including FiBL think 

this is not excluded but more study 

of the methods is needed.

TILLING Eco-TILLING TBD Stands for Targeted Induced Local 

Lesions In Genomes. It is a type of 

mutagenesis combined with a new 

screening procedure.

Agro-infiltration TBD In vitro nucleic acids are introduced

to plant leaves to be infiltrated into 

them. More study needed.

Doubled Haploid Technology TBD There are several ways to make 

double haploids and some do not 

involve genetic engineering but 

some do.

Induced Mutagenesis TBD This is a very broad term and needs 

to be divided and classified based 

on what induces the mutations, 

chemicals, radiation, or other 

stresses.

E. Organic Plant Breeding

Some groups in Europe are moving ahead with developing a full set of organic plant breeding 

standards. If this become regulation there, then a label could be given for an "Organically Bred 

Variety". This is far from being able to be achieved in the U.S.A. with a very different approach 

to seed regulations as a whole. However, it is a potential next step and may be appropriate to 

tie into the discussion of some of the remaining terms above. For more information about this 

see the FiBL dossier cited above.

For instance a variety created with a cell fusion event for brassica male sterility might be 

allowed as seed in organic farming (as it is now) but prohibited from being used in a variety 

labeled as "Organically Bred Variety" with an organic breeding standard.

Discussion Questions

1. Are there any additional criteria for evaluating technologies that need to be considered?

2. Do you have any insights on how to detect those technologies that are excluded but may not 

provide detectable genetically engineered DNA?

3. Please offer any suggestions for enforcement of the excluded method provisions of the rule 

when they are not traceable or detectable.

4. Opinions are welcome on the terms in the chart above that may or may not be clearly 

prohibited as excluded methods.

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Subcommittee Vote

Motion to adopt the third discussion document on Excluded Methods

Motion by: Zea Sonnabend 

Second: Emily Oakley

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

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

organic farming.

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