Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: The National Organic Program (NOP)

Date: November 2, 2017

Subject: Excluded Methods Terminology to be listed in the National Organic Program Excluded 

 Methods Guidance Document

NOSB Chair: Tom Chapman

The NOSB hereby recommends to the NOP the following: 

Guidance Statement: X

Statement of the Recommendation: 

The NOSB has determined three more methods of genetic manipulation be added to the list of 

excluded methods not allowed in certified organic production. These are cisgenesis, 

intragenesis, and agro-infiltration. These three methods were determined to meet the 

descriptions of what activities are considered to be excluded methods, as presented in main 

document and Appendix A of the NOSB Excluded Methods Terminology recommendation of 

November 2016. Cell-fusion is a separate method that is still under review by the NOSB. Cell 

Fusion Techniques used in Seed Production have been addressed in an NOP Policy 

Memorandum dated February 1, 2013.

Rationale Supporting Recommendation (including consistency with OFPA and Organic 

Regulations): 

New technologies and processes continue to be developed in the area of genetic engineering, 

genetically modified organisms, modern biotechnology, synthetic biology and more. The NOSB 

will continue to review current and future methods using its recommended definitions, 

descriptions, terminology, and criteria to provide guidance on which methods should be

allowed in organic production, and which ones should not. The three methods listed above 

have been determined by the NOSB to meet the criteria and descriptions that place them on 

the list of methods excluded from organic production. There was unanimous public comment 

supporting the addition of these three methods to the excluded method list.

NOSB Vote: 

Motion to accept the proposal on excluded methods terminology 

Motion by: Harriet Behar

Seconded by: Dan Seitz

Yes: 15 No: 0 Abstain: 0 Absent: 0 Recuse: 0

 

Outcome: Motion passed
National Organic Standards Board

Materials/GMO Subcommittee Proposal

Additional Excluded Methods to be listed in the

National Organic Program Excluded Methods Guidance Document

August 22, 2017

Introduction and background

On November 18, 2016, the NOSB sent a recommendation to the National Organic Program (NOP), 

recommending the NOP develop a guidance document to improve the definition of excluded methods 

as applied to the use of genetically engineered materials used in agriculture. This recommendation 

provided improved definitions and attempts to address the increased diversity in types of genetic 

manipulations performed on seed, livestock and other inputs used in agriculture. It is understood 

that genetic engineering is a rapidly expanding field in science at this time, and that the NOSB and the 

NOP will need to continually review new technologies to determine if they would or would not be 

acceptable in organic agriculture. In addition to the recommendation passed by the NOSB in 

November 2016, providing a new framework of definitions for determining a genetic manipulation as 

an excluded method, there was also a discussion document that listed numerous technologies that 

needed further review to determine if they were within the definition of prohibited or excluded 

methods.

Goals of this proposal/document

This proposal for the October 2017 NOSB meeting addresses three of the “To Be Determined” 

methods listed in the discussion document voted upon in November 2016. Using the NOSB’s 

proposed improved definitions of GE excluded methods, the NOSB Materials Subcommittee was able 

to determine if certain technologies should be considered an excluded method and therefore the 

products of these type of technologies would not be allowed in NOP organic agricultural production.

Public comment at numerous NOSB meetings over the years, continues to stress the desire 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 all of the 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.

Criteria

The NOSB previously recommended that 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 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.

Definitions

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

a method should be/is excluded. 

A. 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.

B. 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.

C. 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.

D. 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

E. 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

"non-GMO" 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.

F. 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.
It is this series of definitions and terminology was used to as the basis to determine the status of the 

many of the previously “To Be Determined” materials.

The NOSB voted on the methods listed below during its April 2016 meeting, and determined these to be 

excluded methods.

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

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

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 

YES 1, 3, 4

Cloned animals and

offspring

Somatic nuclear transfer YES 1, 3

Plastid

Transformation

YES 1, 3, 4

* CRISPR-Cas = Clustered regularly interspaced short palindromic repeats and associated protein genes.
** TALENs = Transcription activator-like effector nucleases.

The following genetic engineering methods were found to be NOT an excluded method, under the 

proposed new definitions.

Method and

synonyms

Types Excluded

Methods

Criteria 

Applied

Notes

Marker Assisted

Selection

NO

Transduction NO

Discussion

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

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

current definitions. We may also need to incorporate additional criteria into our current definitions in 

order to evaluate new and unique technologies.

We also understand that many of the new technologies do not lend themselves to testing. . However, 

we still believe that the technology should be listed as an excluded method. The Materials 

Subcommittee may put forward another discussion document to aid the NOP in determining how to 

enforce this prohibition when there is no means to test and prove an excluded method was used in 

production.

Proposal

The items below have been determined to be considered an excluded method based upon the criteria 

listed above.

Terminology

Method and synonyms Types Excluded

Methods

Criteria Used Notes

Cisgenesis 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 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.

The following methods will continue to be researched.

Terminology

Method and synonyms Types Exclud

ed

Criteria Used 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.

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 FiBL1

think this is not excluded but

more study of the methods is

TILLING Eco-TILLING TBD Stands for Targeted Induced Local

Lesions In Genomes. It is a type of

mutagenesis combined with a 

new screening procedure.

 1 Research Institute of Organic Agriculture (FiBL) http://www.fibl.org/en/switzerland/location-ch.html
Doubled Haploid 

Technology

TBD There are several ways to make

double haploids and some do

not involve genetic engineering

but some do. Difficult to 

impossible to find using tests.

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.

Subcommittee Vote:

Motion to accept the two sections of this proposal as stated above. 

Motion by: Harriet Behar

Second: Dan Seitz

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

Approved by Harriet Behar, Subcommittee Chair, to transmit to NOSB August 22, 2017