National Organic Standards Board 

Materials/GMO Subcommittee 

Excluded Methods Terminology – Third Discussion Document 

August 30, 2016

Note: The Materials Subcommittee is posting the same discussion document from February 2016 with 

one change. Embryo transfer in animals has been added to the terminology chart with a "TBD", after 

public comment from the Spring 2016 meeting indicated that it should be considered as allowed in 

organic livestock. This and all the issues within this document will warrant further discussion at future 

meetings once the proposal for definitions and criteria is in place. If you submitted comments to the 

Spring 2016 posting, you do not need to send them again.

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 re-examination 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.

• 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.

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 an 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.

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.

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.

Embryo transfer in animals Embryo rescue 

in animals

TBD FiBL distinguishes embryo rescue in 

plants from animals.
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.

Subcommittee Vote

Motion to adopt the third discussion document on excluded methods

Motion by: Zea Sonnabend

Seconded by: Emily Oakley

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

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

organic farming.