Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: the National Organic Program (NOP)

Date: October 25, 2019

Subject: Excluded Methods Determinations - Induced Mutagenesis and Embryo Transfer

NOSB Chair: Harriet Behar

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: X

Other:

Statement of the Recommendation: 

The NOSB recommends that induced mutagenesis be considered an excluded method and 

therefore be prohibited in organic production. Additionally, the NOSB determined that embryo 

transfer in animals does not qualify as an excluded method and therefore would not be 

excluded in organic production. Numerous public commenters reinforced the statement in the 

proposal, that eggs or sperm from cloned animals are not allowed when using embryo transfer 

methods.

This recommendation to the National Organic Program is a continuation of the NOSB’s review 

of various technologies and methods to determine if these methods should be considered an

excluded method. The NOSB’s recommendation of 2016 on this same subject clarified the

definition and terminologies used in the expanding field of genetic engineering. In order to larif

what is allowed and what is not under the National Organic Program regulations, current and 

future NOSB’s are providing proposals to the NOP on specific technologies and whether they 

should be excluded from organic production.

Rationale Supporting Recommendation (including consistency with OFPA and Organic 

Regulations): 

Two methods were discussed and voted upon in this proposal. Induced mutagenesis through 

invitro nucleic techniques and embryo transfer in animals. The induced mutagenesis method 

was found to meet the definition of an excluded method, and the embryo transfer in animals 

did not. Public commenters supported the NOSB’s recommendation, and reinforced the 

statement in the proposal that eggs or sperm from cloned animals are not allowed when using 

embryo transfer methods.
NOSB Vote: 

Motion to accept the proposal on excluded methods determinations October 2019 -

Induced Mutagenesis and Embryo Transfer

Motion by: Harriet Behar

Second: Dan Seitz

Yes: 13 No: 0 Abstain: 0 Absent: 1 Recuse: 0

 

Outcome: Motion Passed
National Organic Standards Board

Materials/GMO Subcommittee Proposal 

Excluded Methods Determinations October 2019

August 13, 2019

Introduction and background

At the November 18, 2016 in-person National Organic Standards Board (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,” clarifies excluded method definitions and criteria in response to the 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. To be responsive to this 

rapid expansion, the NOSB will continue to list new methods for review and will determine over time 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. In April 

2019, one more method was added to the list of methods to be excluded. The organic community, as well 

as the NOSB, has voiced a consistent stance that direct manipulation of genes through in vitro nucleic acid 

techniques should be considered an excluded method. This would include gene editing techniques such as 

CRISPR, which was determined to be an excluded method by the NOSB in November 2016. The NOSB will 

continue to review and determine various methods and technologies to provide clarity to the organic 

community on which methods could be allowed and which ones are excluded.

Goals of this proposal/document

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

discussion document. At the April 2019 NOSB meeting, a discussion document was presented for public 

comment for the two items covered in this proposal: induced mutagenesis and embryo transfer in 

livestock. 

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 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. 

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. 

Definitions and Criteria

Under the National Organic Program organic regulations, methods that employ genetic engineering 

techniques are excluded from use in organic production. The current regulation defines an excluded 

method as:

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. 

Below are the criteria listed in the 2016, 2017, 2018 and 2019 NOSB recommendations to determine if 

methods should be excluded. The table includes the NOSB vote in April 2019, to add transposons

developed via use of in vitro nucleic acid techniques as an excluded method.

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 normal-sense 

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. 

TransposonsDeveloped via use of in 

vitro nucleic acid 

techniques

YES 1,3,4 Does not include 

transposons developed 

through environmental 

stress such as heat, 

drought or cold.

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.

 
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

di d d Cell Fusion within Plant Family TBD Subject of an NOP memo in 

2013. The Crops 

Subcommittee will continue 

to explore the issue of 

 TILLING Eco-TILLING TBD Stands for “Targeted Induced

Local Lesions In Genomes.” 

It is a type of mutagenesis 

bi d ith 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

 Induced Mutagenesis TBD Induced mutagenesis 

developed through exposure 

to UV light, chemicals,

irradiation or other stress 

 

 Transposons TBD Produced from chemicals, 

ultraviolet radiation, or 

other synthetic activities 

 

Discussion and Public Comment 

Induced Mutagenesis

The April 2019 NOSB discussion document covered a variety of methods that could result in 

induced mutagenesis. Public comment overwhelmingly stated that environmental or other 

stresses that induce mutagenesis need more deliberate discussion. Impact on current plant 

breeding methods needs to be carefully considered, as well as consistency with what is allowed 

and not allowed, in organic agriculture. Having clear definitions and accessibility in determining 

which items may or may not have been developed through stress induced mutagenesis is needed 

to provide seed breeders and companies, certifiers, and producers the information they need to 

meet any possible restrictions discussed in the future. 

However, it was clear that induced mutagenesis developed through in vitro nucleic acid techniques 

meets the criteria to be determined as an excluded method. Information is accessible in the 

marketplace to determine if the induced mutagenesis was produced through this method. This 

proposal adds this type of in vitro nucleic acid technique induced mutagenesis to the excluded 
method table and keeps induced mutagenesis developed through exposure to UV light, chemicals, 

irradiation, or other stress-causing activities on the “To Be Determined” list for future discussion 

and review.

Embryo transfer, or embryo rescue, in animals

This technique used in animal breeding, involves inducing superovulation of the donor animal with 

gonadotropins (glycoprotein polypeptide hormones), artificial insemination of the donor animal, 

recovery of embryos from the donor, isolation and storage of embryos, and transfer of embryos 

into a recipient animal (either with or without hormones to synchronize estrus), which results in a 

pregnancy and hopefully a birth of a live animal at maturity. Many organic certifiers stated they 

currently allow this method of embryo transfer in organic agriculture. In nonorganic agriculture, 

the recipient animal may also be given hormones to improve the success of the embryo transfer, 

but no organic certifiers allowed the use of these hormones in the recipient animal to synchronize 

estrus. 

In response to the question of whether this technique might narrow the genetic pool in livestock, 

commenters were sympathetic to this concern but felt that organic farmers would be careful in 

choosing embryos that would result in genetic diversity in their livestock. There were no concerns 

expressed for the health of the nonorganic donor animal after repeated use of hormones to 

produce multiple embryos, nor possible future health issues in the animals grown from those 

embryos. While embryo transfer was not found to be a necessary method by the public, numerous 

commenters stated it is a useful tool that should be allowed.

Future Work on this Topic

The NOSB encourages the public to continue the dialogue on the various methods that cause induced 

mutagenesis and provide information on which methods, chemical, UV light, irradiation, or others should or 

should not be considered excluded for organic production.

Subcommittee Proposal

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

methods guidance: 

1. Induced mutagenesis - 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 the NOP 

excluded methods guidance: 

2. Embryo transfer, or embryo rescue, in animals. Use of hormones not allowed in recipient animals.

Subcommittee Vote:

Motion to accept the proposal on excluded methods determinations October 2019 

Motion by: Harriet Behar

Second: Dan Seitz

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

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