Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: the National Organic Program (NOP)

Date: April 26, 2019

Subject: Excluded methods determinations April 2019

NOSB Chair: Harriet Behar

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: X

Statement of the Recommendation: 

This recommendation continues the ongoing work to determine whether or not specific 

technologies should be considered excluded methods using the current regulatory definition of 

an excluded method and the 2016 NOSB formal recommendation entitled “Excluded Methods 

Terminology”. This proposal covers various methods that could result in transposons, and 

provides information on what transposons are as well as further clarification on the definitions 

of cisgenesis and intragenesis, which were voted as excluded methods at a previous NOSB 

meeting.

Rationale Supporting Recommendation (including consistency with OFPA and Organic 

Regulations): 

One small change was made to the chart within the document, to clarify that “Transposons 

developed via use of invitro nucleic acid techniques” was the method that should be considered 

to be excluded. There was no change made to the proposal motion voted out of 

subcommittee, since that language was already present. This determination is consistent with 

the NOP final rule and with the NOSB recommendation which helps to determine which 

technologies should be excluded under the organic label.

NOSB Vote: 

Motion to accept the proposal on excluded methods determinations April 2019 

Motion by: Harriet Behar

Second: Dave Mortensen

Yes: 14 No: 0 Absent: 0 Abstain: 0 Recuse: 0

 

Motion Passed
National Organic Standards Board

Materials/GMO Subcommittee Proposal 

Excluded Method Determinations April 2019

February 12, 2019

Introduction and background

At the November 18, 2016, in-person 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,” clarified the excluded 

methods definitions and criteria in response to 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. The NOSB recognizes the need to continually add 

methods to the list for review and to determine if the methods are or are not acceptable in organic

agriculture. In addition to the 2016 recommendation, a discussion document provided a list of 

technologies needing further review to determine if they should be classified as excluded methods or not. 

At the Fall 2017 NOSB in-person meeting, the NOSB passed a recommendation to add three technologies 

as excluded methods to the NOP guidance document. In Fall 2018, the NOSB recommended one 

technology be added to the list of methods that are not to be excluded in organic production.

Goals of this proposal/document

This proposal addresses three more items on the “To Be Determined” list found in the November 2016

discussion document. Using the NOSB’s proposed improved definitions of excluded methods, the NOSB

Materials Subcommittee has clarified what type of technologies used to cause transposons should be

excluded methods in organic agriculture and what type of activity should not be excluded. 

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 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. 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. 

Criteria

Below are the criteria listed in the previous 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.

The NOSB has voted and determined these 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

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 normalsense 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.

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.

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.
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 to evaluate new

and unique technologies.

We are aware that specific laboratory tests are not currently available to detect the use of several

new excluded genetic modification technologies in organisms. However, we still believe that the

technology should be listed as an excluded method, when appropriate, and anticipate tests or 

other methods will be developed over time to detect the presence of these technologies. The

Materials Subcommittee may put forward another discussion document in the future to aid the

NOP in determining how to enforce this prohibition when there is no means to detect an

excluded method that may have been used in production. 

In the Fall 2018 discussion document, there were descriptions assigned to both cisgenesis and 

intragenesis. These descriptions are still valid, and in this document we would like to add the 

following to further clarify these two technologies. There is no further clarification for 

agroinfiltration proposed.

• Cisgenesis—The gene modification of a recipient plant with a natural gene from a crossablesexually compatible-plant. The introduced gene includes its introns and is flanked by its native 

promoter and terminator in the normal-sense orientation.

• 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.

The following 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 

of detection and testing.

TILLING EcoTILLINGTBD Stands for “Targeted Induced Local Lesions In

Genomes.” It is a type of mutagenesis combined

with a new screening procedure.
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 This is a very broad term and needs to be

classified based on what induces the mutations, 

such as chemicals, radiation, or other stresses.

Transposons TBD Produced from chemicals, ultraviolet radiation,

or other synthetic activities considered to be a 

method of “induced mutagenesis”

Embryo transfer in animals Embryo

rescue

in 

animals

TBD FiBL distinguishes embryo rescue in plants from

animals. A technique used in animal breeding,

FiBL involves inducing superovulation of the 

donor with gonadotropins (glycoprotein 

polypeptide hormones), artificial insemination, 

recovery of embryos, isolation and storage of 

embryos, and transfer of embryos into an 

animal, which results in a pregnancy and 

hopefully a birth of a live animal at maturity. 

More research is needed to clarify if use of 

hormones is essential to this technique.

Transposons

• Transposons are jumping genes that can occur in nature and are responsible for mutations

through mobile genetic elements. Transposon activity can be modified through stress or genetic 

engineering to increase mutation rates. Changes or mismatches to the individual nucleotides 

occurs, altering the cell’s genetic identity and genome size. When the transposon cleaves from its 

original location to another location, there is also a change to the genetic makeup at the site 

where it no longer resides. 

• Transposons are responsible for mutations when moving around within a genome. Various forms 

of environmental stress, such as heat, cold or drought, as well as stress caused by chemicals or 

exposure to irradiation, can increase the movement of naturally occurring transposons which 

then results in higher mutation rates.

• Transposons can also be developed in a laboratory using in vitro nucleic acid techniques to then 

be introduced into plants or animals.

• IFOAM’s 2018 position paper on Techniques in Organic Systems considers transposons caused by 

physical stress to be compatible with organic systems.

• Transposons, when produced from chemicals, ultraviolet radiation, or other synthetic methods, 

are considered to be a method of “induced mutagenesis”. Further research and discussion are

needed to determine if induced mutagenesis methods, both those that are random or targeted, 

should be considered excluded from organic production, or not.
The method below has been determined to be an excluded method based upon the criteria listed

above.

Method and synonyms Types Excluded

Methods

Criteria Used Notes

Transposons developed via 

use of invitro nucleic acid 

techniques

YES 1, 3, 4 Developed via use of in vitro nucleic 

acid techniques

The method below has been determined to not be an excluded method based upon the criteria 

listed above.

Method and synonyms Types Excluded

Methods

Criteria Used Notes

Transposons NO Developed through environmental 

stress, such as heat, drought, or cold

The method below needs further review.

Method and synonyms Types Excluded

Methods

Criteria Used Notes

Transposons TBD Produced from chemicals, ultraviolet 

radiation, or other synthetic activities

considered to be a method of 

“induced mutagenesis”

Future Work on this Topic

The Materials Subcommittee has developed a discussion document for the April 2019 NOSB meeting to 

encourage public input on embryo transfer in animals and the various methods of induced mutagenesis. 

Subcommittee Proposal

The NOSB recommends the NOP add the following to the table of excluded methods, in NOP excluded 

methods guidance.

1. Transposons - Developed via use of in vitro nucleic acid techniques.

The NOSB recommends the NOP add the following to the table of “not excluded” methods, in NOP 
excluded methods guidance.

2. Transposons - Developed through environmental stress, such as heat, drought or cold.

3. Add these two definitions to the excluded methods terminology chart for Cisgenesis and Intragenesis

• Cisgenesis—The gene modification of a recipient plant with a natural gene from a crossablesexually compatible-plant. The introduced gene includes its introns and is flanked by its native 

promoter and terminator in the normal-sense orientation.

• 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.

Subcommittee Vote

Motion to accept the proposal on excluded methods determinations April 2019

Motion by: Harriet Behar

Second: Dave Mortensen

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

Approved by Emily Oakley, Materials Subcommittee Chair, to transmit to NOSB February 13, 2019