Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: National Organic Program (NOP)

Date: October 26, 2018

Subject: Excluded Methods Determinations

NOSB Chair: Tom Chapman

The NOSB hereby recommends to the NOP the following:

Rulemaking Action: 

Guidance Statement: X

Other:

Statement of the Recommendation: 

This proposal recommends that embryo rescue in plants not be considered an excluded method 

for organic production.

Rationale Supporting Recommendation 

Because embryo rescue does not meet the various criteria used to characterize a method as 

excluded, the NOSB found this type of plant breeding to be acceptable in organic production. 

This method does not use techniques of genetic engineering that have compromised cell 

nucleus integrity through overcoming natural, physiological reproductive or recombination 

barriers. This proposal relied on the 2016 NOSB recommendation on Excluded Methods 

Terminology to make this determination as well as the definition of excluded methods in the 

Organic Regulations.

NOSB Vote: 

Motion to accept the proposal on Excluded Methods determinations

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 

Excluded Method Determinations October 2018 

August 14, 2018

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. This 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.

Goals of this proposal/document

This proposal for the October 2018 NOSB meeting addresses three additional methods listed as “To Be 

Determined” in the November 2016 discussion document. Using the NOSB’s proposed improved

definitions of excluded methods, the NOSB Materials Subcommittee identified one technology as an 

excluded method in organic agriculture and another technology as a method that should not be 

excluded in organic agriculture. 

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 be used under the USDA organic seal. 

Definitions

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)

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 more accurately assess phenotypes, however the emphasis must be on

whole plant selection.

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 invasion into the plant

genome.

2. The ability of a variety to reproduce in 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 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 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
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

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 the 

development of tests or other methods that can 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 was used in production. 

Public comment received has been positive regarding the listing of all proposed excluded and nonexcluded methods listed above. At the November 2017 meeting, when three new items were 

added to the excluded methods list, there were numerous comments requesting a clear 

description of the methods used in these excluded technologies. The three items added were 

cisgenesis, intragenesis, and agro-infiltration. Basic descriptions of these technologies are

described below.

• Cisgenesis—the intact DNA of a plant is directly modified through gene transfer, and the integrity of 

the nuclear genome is disturbed. The introduced gene is from the same taxonomic family. 

Cisgenesis is a form of genetic engineering where genes are artificially transferred from the same 

species, or between closely related organisms. Unpredictable outcomes can occur through gene 

transfer, random or otherwise, even within the same species, through the introduction of intended 

or unintended change to genetic sequences and unintended insertions of novel bacteria, viruses or 

DNA to the host.

• Intragenesis—the intact DNA of a plant is directly modified through gene transfer, and the integrity 

of the nuclear genome is disturbed. The introduced gene or multiple genes are from the same

taxonomic family, and the gene sequence may be rearranged. The same inherent risks of cisgenesis 

caused by the unpredictable outcomes of gene modification technology, are also risks associated 

with intragenesis.

• Agro-infiltration—in vitro nucleic acids, usually via a bacterial transporter, are introduced to plant

leaves by direct injection or by vacuum infiltration into the plant. This method manipulates the 

genetic code within the nucleus of the organism. The goal is to produce a desired protein not 

present in the plant. The bacteria can make a hole in the cell wall, move into the nucleus of the 

plant and integrate into the plants’ chromosomes. Stable integration into the plant’s cell structure 

is not guaranteed. Agro-infiltration can also be used to silence specific genetic traits, although exact 

knowledge of how this is working at a genetic level is not currently known.

Proposal

Two items were considered for this proposal. One item was determined to be an excluded method 

depending on the method used to cause the change to the organism. The other method was determined to 

not be an excluded method.

Transposons, when produced from chemicals, ultraviolet radiation or other synthetic methods, are to be 

added to the list of excluded methods.

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

activity can be modified to increase mutation rates. This can be done by chemicals or by physical 
stress like drought or heat. 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.

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

physical stress to be compatible with organic systems.

• The NOSB livestock subcommittee discussed transposons in an August 2014 Memorandum to the 

NOP on Livestock Vaccines Made with Excluded Methods. Transposons were described as follows in 

that document.

Transposons, also called transposable elements, are naturally occurring, double stranded DNA

sequences with a defined structure. Each end of the transposon includes inverted repeats. In

prokaryotes, the internal structure includes at least one gene for transposase and may contain

many more depending upon the type of transposon. Genes for antibiotic resistance, one

example of the types of transposon genes, occur both naturally and sometimes as a marker

in lab modified transposons. When the transposase gene is expressed, the protein binds to the

inverted repeats of the transposon, cleaves the genomic DNA and excises the transposon.

Transposase can then cleave the genomic DNA at another spot and recombine the transposon

into a new position in the genome.

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 YES - when 

produced 

by any 

means 

other than 

physical 

stress

1, 3, 4 Can be naturally occurring due to 

drought, heat or other means of 

physical stress, are not an excluded 

method. 

Transposons produced through 

chemical, artificial ultra violet 

radiation or other synthetic stress or 

interaction is considered to be an 

excluded method.

The following technology was found to not be an excluded method.

• Embryo rescue in plants—a technique that recovers plants from sexual crosses in which the majority 

of the embryos cannot survive in-vivo or may have gone dormant. The method helps to overcome 

embryo unviability, due to inherent weakness, immaturity or hybrids that degenerate. This method 

can combine desirable traits of complementary parents, such as in the development of seedless fruits.

This method aids in shortening the breeding cycle. Embryos are placed in a controlled sucrose 

culture, for specific times and under controlled temperatures and light, to aid in the successful 

recovery of viable plants. The IFOAM position paper “Compatibility of Breeding Techniques in Organic 

Systems states, “In order to improve frequency of progeny of wide crosses, the embryo is transferred 

to artificial media. The embryo is derived from natural fusion of an egg and pollen cell. However, in 

wide crosses, the endosperm is often not well developed to feed the embryo. This method was used 

to produce triticale (Triticum aestivum x Secale cerale).” IFOAM also states this is compatible with 

organic systems.
Method and synonyms Types Excluded

Methods

Criteria Used Notes

Embryo rescue in plants No IFOAM’s 2018 position paper on 

Techniques in Organic Systems 

considers this technique compatible 

with organic systems.

The following methods will continue to be researched.

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

Cell Fusion within Plant 

Family

TBD Subject of an NOP memo in2013. 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.

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.
Future Work on this Topic

The Materials Subcommittee will discuss embryo transfer in animals, study the various methods of induced 

mutagenesis, and will review the NOP February 2013 policy memorandum on cell fusion techniques used in 

seed production. We will continue to review new technologies as they are introduced to the marketplace, such 

as GAANTRY (Gene Assembly in Agrobacterium by Nucleic acid Transfer using Recombinase Technology), as

additions to our list of methods for discussion and classification.

Subcommittee Proposal:

The NOSB recommends the NOP add the following to the table of excluded or not excluded methods in the 

NOP excluded methods guidance.

1. “Transposons, when produced from chemicals, artificial ultraviolet radiation or other synthetic 

methods,” is to be added to the table listing excluded methods.

2. “Embryo rescue in plants” should be listed “not an excluded method”.

Subcommittee Vote:

Motion to accept the proposal on excluded methods as stated above

Motion by: Harriet Behar

Second: Dan Seitz

Yes: 4 No: 0 Absent: 3 Abstain: 0 Recuse: 0

Approved by Harriet Behar, Materials Subcommittee Chair, to transmit to NOSB August 21, 2018