Formal Recommendation From: National Organic Standards Board

Formal Recommendation

From: National Organic Standards Board (NOSB)

To: the National Organic Program (NOP)

Date: November 18, 2016

Subject: Excluded Methods Terminology Recommendation

NOSB Chair: Tracy Favre

The NOSB hereby recommends to the NOP the following:

Rulemaking Action:

Guidance Statement: X

Other:

Statement of the Recommendation:

The NOSB Materials/GMO subcommittee approves the three sections of this proposal:

1. Approve the definitions of Genetic Engineering (GE), Genetically Modified Organism (GMO),

Modern Biotechnology, Synthetic Biology, Non-GMO, and Classical/Traditional Plant Breeding

as written above.

2. Approve the Principles and Criteria above that will be used in the evaluation of new

technologies and terminologies.

3. Adopt the Terminology chart proposed above and the listings in it as presented, with the

removal of the Dupont Seed Production Technology term, recognizing that this will be added to

as further deliberations occur in the future.

Rationale Supporting Recommendation (including consistency with OFPA and Organic

Regulations):

Excluded Methods are prohibited in the USDA organic regulations, but the definition in the

regulation that was adopted in 1995 needs updating in light of new technologies and processes.

The NOSB recommends that this set of supplemental definitions, criteria for review of new

technologies, and terms that are included in the definition of excluded methods, be addressed

in guidance on interpreting the excluded methods provision in the regulations.

NOSB Vote:

Motion by: Zea Sonnabend

Seconded by: Emily Oakley

Yes: 14 No: 0 Abstain: 0 Absent: 1 Recuse: 0

Motion Passed

National Organic Standards Board

Materials/GMO Subcommittee Proposal

Excluded Methods Terminology

August 30, 2016

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

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 resulted in gray areas for the organic standards

regarding interpretation and enforcement.

In 2011 and 2012 a number of confusing issues came before the NOSB and to the NOP which made it

necessary to revisit the definition. These include genetically engineered vaccines for livestock, the use of cell

fusion within plant families to create male sterility in brassica hybrids, whether or not GMOs could be used

in biodegradable bioplastic mulches, and the question of whether mutated algae might therefore be

genetically engineered. The current definition is inadequate to clarify these issues. In the last few years the

rise of gene editing with no insertion of foreign DNA, synthetic biology, and the genetically engineered

insects that are starting to appear make this effort even more important.

The first NOSB Discussion Document on excluded methods in 2013,

discussed each of the terms in the

above definition, defined and discussed other terms involved in traditional breeding, such as mutagenesis

and conjugation, and brought up new terms that may be considered to be genetic engineering. No

conclusions were suggested except that there is a need to do more work on the subject. The discussion

questions posed asked commenters to suggest principles on which to base GE distinctions, to offer opinions

on what terms were and were not excluded methods, and to bring forward new terms that may need

consideration.

The second NOSB discussion document posted in September 2014 and in April 2015

analyzed the

comments received and proposed several options for an updated definition, and principles and criteria to

use when evaluating the various genetic modification issues. Additional terms were collected and the

beginnings of some definitions were started. A structure was proposed similar to the one in use by the

Research Institute of Organic Agriculture (FiBL) in Europe that involves an itemized chart with a yes/no

column where the specific techniques could be itemized and evaluated. The Subcommittee made an

informal recommendation, which was not voted upon, that these revisions to the definition and structure

for evaluating techniques be regulated through NOP guidance rather than additional rulemaking. Lastly it

was acknowledged that there will be some unresolved issues that will need continued public discussion

because they pose enforcement challenges, are totally hidden from view, or not enough is known about

them yet.

Both a proposal and a discussion document were posted for the April 2016 NOSB meeting. While comment

regarding the approach was generally favorable, there clearly was a need for some refinement of the

definitions and criteria. There was also confusion about which techniques were part of the proposal and

which remained to be discussed further.

Goals of This Proposal/Document

The need for forward motion on this subject is more pressing every month. The fact that over 1000 pages of

scientific references were submitted in public comment, with most of it consisting of research published

since the NOSB GMO ad hoc Subcommittee was formed in 2012, indicates that the biotech community is

rapidly outpacing any regulatory structure. The U.S. Department of Agriculture (USDA) has already ruled that

certain plants produced with novel approaches to genetic manipulation will not be regulated in the United

States

as genetically modified organisms. It is more imperative than ever that the organic community be

very clear about where the line is drawn regarding genetic engineering.

Public Comment from the past two and a half years has indicated strong support for this effort on the

whole, although there is not consensus on some details. Every organic stakeholder is clear that genetic

engineering is an imminent threat to organic integrity. The NOSB must make, to the extent it can, every

effort to protect that integrity. .

The Materials Subcommittee is putting forth a structure for reviewing new technologies, and disseminating

the results of the review in a transparent manner. To this end, the proposal portion of this document

includes supplements to the definition in the rule based on internationally accepted language, criteria to use

in the reviews based on that definition, and a chart of those techniques that are clearly "excluded methods"

based on the definition and criteria.

A separate discussion document contains the technologies, terms, and issues that the NOSB has not been

able to agree on or on which it does not yet have enough information, or that pose challenges that have not

yet been addressed. These items are put forth for discussion to collect further public comment, and will be

reviewed at future NOSB meetings.

Definitions

In the previous discussion document the NOSB suggested a couple of possible definitions that would update

the text in the rule to be more comprehensive, and also be flexible enough to accommodate future

technologies and terms. The Board favors the definitions in use by Codex Alimentarius that were also in the

Cartagena Protocol.

During the course of public comment and subsequent discussion, it has become clear that more than one

definition is important to the organic community, but that all the terms the NOSB suggests defining here

would fall under the Excluded Methods definition in the rule and would not change, but would strengthen

that definition. These definitions are to be used in guidance to supplement and update the definition in the

regulations, while leaving the rule itself intact. It is important to adopt some definitions that are widely

accepted internationally and thus provide common ground with other countries who are concerned about

GMOs in organics.

Based on public comment on the Spring 2016 proposal, we decided to add a definition for

classical/traditional plant breeding. Traditional breeding is a term used in the Excluded Methods definition in

the rule and is therefore important to clarify. . However because the other definitions and criteria are not

unique to plants, we slightly changed the wording so that they are applicable to all organisms.

In October 2015 the International Federation of Organic Agriculture Movements (IFOAM) published a

Discussion Paper on a proposed revision to their Position on Genetic Engineering.

Since other countries do

not use the concept of "Excluded Methods",, IFOAM proposed new definitions for three terms: Genetic

Engineering (GE), Genetically Modified Organism (GMO), and Synthetic Biology. After examining their

definitions, the Materials/GMO Subcommittee (MS) agrees that these three terms are important to define in

the guidance it are proposing. However, we do not wish to use the old approach (that IFOAM is still using) of

trying to capture all the methods and terms into one definition, in because it will be out of date as soon as

the next round of new technologies arrives.

Instead we are proposing that the following definitions of terms and acronyms, with sources, be adopted by

the NOSB as Excluded Methods

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. (First sentence modified from IFOAM Position cited above)

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 cited above)

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 "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. (Modified based

on public comment from Spring 2016 NOSB)

Both definitions and criteria were worked on in between the Spring and Fall NOSB meetings by an ad hoc group with

the following members: Julie Dawson, University of Wisconsin; David Gould, International Federation of Organic

Agriculture Movements (IFOAM); Michael Hansen, Consumers Reports; Jaydee Hanson, Center for Food Safety; Kristina

Hubbard, Organic Seed Alliance; Melody Meyer, United Natural Foods; James Myers, Oregon State University; Dana

Perls, Friends of the Earth; Erica Renaud, Vitalis Organic Seeds; Dan Seitz, National Organic Standards Board (NOSB);

Michael Sligh, Rural Advancement Fund International; Zea Sonnabend, Fruitilicious Farm and NOSB; Jim thomas, ETC

Group; William Tracy, University of Wisconsin; Gwendolyn Wyard, Organic Trade Association.

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.

This series of definitions provides a better framework than the existing definition, as it elaborates the

various technologies that would be prohibited as well as those which would be allowed. We propose to

combine these definitions, the principles and criteria discussed below, and the terminology chart presented

into this proposal for guidance on excluded methods.

Principles and Criteria

The NOSB has its own set of Principles of Organic Production and Handling in its Policy and Procedures

Manual

. The principles start with:

1.1 Organic agriculture is an ecological production management system that promotes and

enhances biodiversity, biological cycles, and soil biological activity. It emphasizes the use of

management practices in preference to the use of off-farm inputs, taking into account that regional

conditions require locally adapted systems. These goals are met, where possible, through the use of

cultural, biological, and mechanical methods, as opposed to using synthetic materials to fulfill

specific functions within the system.

Regarding Genetic Engineering:

1.11 Genetic engineering (recombinant and technology) is a synthetic process designed to control

nature at the molecular level, with the potential for unforeseen consequences. As such, it is not

compatible with the principles of organic agriculture (either production or handling). Genetically

engineered/modified organisms (geo/gmos) and products produced by or through the use of

genetic engineering are prohibited.

The following principals of Organic Agriculture are used by IFOAM

and summarize well the guidance for

developing a position on GMO technology.

• Principle of Health: Organic Agriculture should sustain and enhance the health of soil, plant, animal,

human and planet as one and indivisible.

• Principle of Ecology: Organic Agriculture should be based on living ecological systems and cycles,

work with them, emulate them and help sustain them.

• Principle of Fairness: Organic Agriculture should build on relationships that ensure fairness with

regard to the common environment and life opportunities.

• Principle of Care: Organic Agriculture should be managed in a precautionary and responsible

manner to protect the health and well-being of current and future generations and the

environment.

Using the principles above, 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 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.

Most of the techniques that are considered to be genetic engineering are clearly not compatible with the

principal of ecology because they do not work within living ecological systems or sustain them. They are also

at odds with the Principal of Fairness because they are not available equally to all stakeholders and are often

patented or used to create patented traits. There are significant questions around the Principle of care for

the health and well-being of future generations and the environment. These concerns do not change just

because a technique cannot be tested for or does not use DNA foreign to the target organism.

The secondary effects from the use of GMOs are starting to emerge clearly in parallel with the new

technologies. Issues such as reduction in diversity on farms where GMOs are grown, the demise of beneficial

species both above and below the soil, the decline in soil fertility and resilience from increased use of

herbicides, the evolution of weeds resistant to those herbicides, the altered nutritional profiles of the GMO

crop products, and the displacement of small farmers from their land are all violations of the principals of

organic agriculture.

Process and Product

Since the whole underpinning of the U.S. organic regulations is a process-based system, it makes sense that

this concept carry over to defining excluded methods. This is indeed the basis of the current definition.

However, this is not currently how U.S. government agencies regulate GMOs

, or handle other issues such

as pesticide residues or water quality standards.

Newer technologies, known as Targeted genetic modification (TagMo) or targeted genome editing, are

emerging and being adopted quickly.

These are very clearly genetic engineering techniques but are not

regulated by the current government structure because they do not involve DNA from a "pest" under the

USDA APHIS regulatory structure. Many of these techniques involve precise changes in existing DNA without

using foreign DNA from a different species. These new technologies make genetic modification much more

accessible and less expensive. The resulting plants may not show up as genetically engineered in the

commonly used testing methods because they contain no foreign DNA, just native DNA that has been

changed at the allele level by humans.

Forward Movement towards Structure

FiBL Research Institute for Organic Agriculture from Switzerland submitted a comment in 2013 that included

a chart that describes methods with a yes/no column for compatibility with organic standards for both

plants and animals

. The NOSB posed adopting such a chart on the methods that receive consensus and can

be incorporated into guidance. It is important to identify all of these terms so that it is clear that they fall

under the definition of excluded methods, but these terms do not need to be added to the definition itself.

The first version of such a chart for the NOSB is presented here. Appendix A provides a brief description of

each term with additional citations for those who want to find out more about the terms. There is so much

terminology and so many techniques with similar or multiple names that we have added a column for

additional names and types used for each general process. Along with lack of regulation of some of these

processes, there is lack of standardization of the terms, so that new names and sometime proprietary ones

are emerging all the time.

We would especially like to acknowledge the work done by the Center for Food Safety in their public

comment for the April 2015 meeting. They have helped organize all the various terminology and provided

substantial scientific papers that discuss all the terms.

The technologies are grouped by the tasks that the

methods accomplish and the types of changes made to the engineered organism. In the context of this

proposal we are not able to discuss most of the terms at length so please see the Appendix and the CFS cited

comment for the full reference list.

For this version of the proposal, the ones that were marked "TBD" in the previous chart below are now

moved to the accompanying Discussion Document. The ones presented here are those that we are voting on

as either Excluded or Allowed. A column has been added for which criteria apply to the excluded techniques

that have led to our conclusion to exclude them.

Terminology Chart

Method and

synonyms

Types

Exclude

Method

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 (RTDS) (Cibus)

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

Dupont Seed Production

Technology (SPT)

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

Marker Assisted

Selection

Transduction

* CRISPR-Cas = Clustered regularly interspaced short palindromic repeats and associated protein genes.

** TALENs = Transcription activator-like effector nucleases.

Proposal

This proposal has three sections, to be used in NOP guidance on excluded methods:

1. Approve the definitions of Genetic Engineering (GE), Genetically Modified Organism (GMO), Modern

Biotechnology, Synthetic Biology, Non-GMO, and Classical/Traditional Plant Breeding as written above.

2. Approve the Principles and Criteria above that will be used in the evaluation of new technologies and

terminologies.

3. Adopt the terminology chart proposed above and the listings in it as presented, recognizing that this will

be added to as further deliberations occur in the future.

Subcommittee Vote

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

Motion by: Zea Sonnabend

Second: Emily Oakley

Yes: 4 No: 0 Absent: 1 Abstain: 1 Recuse: 0

Appendix A –

Brief Description and Additional Citations for Terms used in Excluded Methods Terminology Chart.

Only terms that are marked YES or NO as Excluded Methods are defined here. All those marked TBD are still

being worked on in discussion. Those marked "syn." are defined in cited reference from Center for Food

Safety Public Comment in April 2015

. Some other definitions are from the NOSB previous discussion

document

and from the FiBL 2015 plant breeding dossier.

Targeted genetic modification (TaqMo) (Kuzma and Kokotovich 2011, Kokotovich and Kuzma 2014) - a

collective term for the zinc finger nuclease techniques that create DNA double-stranded breaks at

specific genomic locations that can then be used to alter the target gene. The genetic modification

would not necessarily involve transfer of nucleic acids from another species, nor would it be easy to

detect in a final product.

• syn. Synthetic gene technologies (Then 2015)

• syn. Genome engineering (Voytas and Gao 2014)

• syn. Gene editing (Puchta and Fauser 2013)

• syn. Gene targeting (GT) (Puchta and Fauser 2013, Endo et al. 2015)

• syn. Sequence-specific nucleases (SSNs) (Voytas and Gao 2014):

• syn. Meganucleases (Gao et al. 2011, as cited in FSANZ 2013)

• syn. Site directed mutagenesis via oligonucleotides, zinc finger nuclease (ZFN) (Dow, APHIS

2012) - an introduction of recombinant DNA through transient molecules that are identified by

zinc-finger nucleases, with or without a repair template. The techniques resemble transgenesis

but the end products are similar to, and indistinguishable from, conventionally bred plants.

• syn. Clustered regularly interspaced short palindromic repeats and associated protein genes

(CRISPR-Cas system) (NYTs 3/20/2015) – a protein called Cas9 enables breaks in DNA at specific

spots so that additional pieces of DNA and RNA can be inserted.

• syn. Transcription activator-like effector nucleases (TALENs) (Sprink et al. 2014).

• syn. Oligonucleotide directed mutagenesis (ODM) (Lusser et al. 2011)

• syn. Cibus Rapid Trait Development System (RTDS) (Beetham et al. 2012 patent) - Similar to the

oligonucleotide targeted DNA modification it does not leave behind transgenic material, only

uses it to create a change in a precise area of a gene.

Gene silencing via RNAi and DNA methylation - Interfering with the regulation of gene expression through

inserting methyl groups onto RNA and DNA that then suppress the expression of the gene. Can occur

in nature, but is used as a recombinant technique in cancer research and plant breeding.

• syn. RNA-dependent DNA methylation (RdDM) (Lusser et al. 2011)

• syn. Gene silencing via RNAi pathway (Casacuberta et al. 2015, Baier et al. 2014, Lubasik and

Zielenkiewicz 2014, Hirschi 2012, Heinemann et al. 2013, Lundgren and Duan 2013, Wagner et al.

2015) – A technique in which a small strand of RNA is inserted into a DNA sequence to regulate the

expression of the gene. There is no change to the DNA sequence, but there is technical interference

with the genome.

• RNAi-based pesticides (Palli 2014, Zhu 2013) – RNA interference (RNAi) is a technique in which gene

silencing RNA strands are inserted into a target genome in order to regulate the expression of target

genes. It was used to engineer rootworm resistant corn as well as to genetically engineer insects

themselves.

Accelerated Plant Breeding Techniques

• Reverse Breeding (Dirks et al. 2009) – A process that uses several other techniques such as RNAi to

suppress meiotic recombination, tissue culture, and then double haploidization to create parental

lines that are homozygous to use in breeding F1 hybrids.

• Genome elimination (Comai 2014)

• FasTrack (Waltz 2012) – a breeding scheme that has so far been used in plums where an early-

flowering gene from poplar is inserted into a plum tree. When the plum flowers in less than a year,

it is crossed with non-transgenic varieties carrying desirable traits. Markers are used to identify the

right traits and, at the end of the breeding program, only those are selected that do not have the

transgene.

• Fast flowering (Flachowsky et al. 2011)

•

DuPont’s Seed Production Technology (SPT) (Waltz 2012)

Synthetic Biology (see definition in main document)

• Synthetic chromosomes (Shenoy and Sarma 2010, pp. 12-13; Gaeta et al. 2012)

Embryo Transfer in animals – a technique used in animal breeding. It involves inducing superovulation of

donor with gonadotropins, artificial insemination, recovery of embryos, isolation and storage of

embryos, transfer of embryos back into animals, and then pregnancy.

Plastid transformation (Maliga 2004, as cited in NOSB discussion 2014) – Plastids are semi-autonomous

organelles within higher plants with a small, highly polyploid genome. Technology has been

developed for genetic modification of this genome independent of nuclear DNA. Currently used

commercially in tobacco, and widely researched.

Marker Assisted Selection – Molecular markers are used as diagnostic aids to determine differences in the

DNA sequence. They can help in selecting desired traits. The markers do not change the DNA of

living plants and are not considered to be genetic engineering.

NOSB 2013. Excluded Methods Terminology Discussion Document. April 2013.

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5102656

National Organic Standards Board Materials/GMO Subcommittee. (2014). Discussion Document on Excluded Methods

Terminology. August 22.

Waltz, E. (2012). Tiptoeing around transgenics. Nature Biotechnology, 30, 215-217. doi:10.1038/nbt.2143

IFOAM – Organics International, 2015, 2015 Discussion Paper on a Proposed Revision to Position on Genetic

Engineering and Genetically Modified Organisms in Organic Agriculture.

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/Discussion_paper_on_GMO_position_2015.pdf

IFOAM – Organics International, 2002, Postition on Genetic Engineering and Genetically Modified Organisms, P01,

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/IFOAM_GMO_Position_Paper.pdf

Codex Alimentarius Commission (2003). “Principles for the Risk Analysis of Foods Derived from Modern

Biotechnology,” CAC/GL 44>2003. Amended 2008, 2011, available at: http://www.fao.org/faoDwhoD

codexalimentarius/shD

proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandar

ds%252FCAC%2BGL%2B44D2003%252FCXG_044e.pdf.

Two other definitions were looked at when this one was chosen: Synthetic Biology – Designing and constructing

biological devices, biological systems, biological machines and biological organisms using a range of methods derived

from molecular biology and biotechnology, including in virtually all cases the techniques of genetic engineering or

genetic modification. (From IFOAM Position cited above). Synthetic biology is a maturing scientific discipline that

combines science and engineering in order to design and build novel biological functions and systems. This includes the

design and construction of new biological parts, devices, and systems...as well as the re-design of existing, natural

biological systems for useful purposes.” (from SynBerc, the University of California/Department of Energy synthetic

biology research consortium)

Link to the European Commission's draft definition with discussion:

http://ec.europa.eu/health/scientific_committees/consultations/public_consultations/scenihr_consultation_21_en.ht

NOSB Policy and Procedures Manual: https://www.ams.usda.gov/sites/default/files/media/NOSB-

PolicyManual.pdfhttps://www.ams.usda.gov/sites/default/files/media/NOSB-PolicyManual.pdf

http://www.ifoam.bio/sites/default/files/poa_english_web.pdf

FiBL Research Institute of Organic Agriculture 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070

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

organic farming.

IFOAM – Organics International, 2015, 2015 Discussion Paper on a Proposed Revision to Position on Genetic

Engineering and Genetically Modified Organisms in Organic Agriculture.

https://gallery.mailchimp.com/75bdff144a46c1e451eecde10/files/Discussion_paper_on_GMO_position_2015.pdf

Kuzma J, Kokotovich A (2011) Renegotiating GM crop regulation. EMBO reports 12: 883–888.

Kokotovich A, Kuzma J (2014) Conflicting Futures: Environmental Regulation of Plant Targeted Genetic Modification.

Bulletin of Science, Technology & Society 34: 108–120.

FiBL Research Institute of Organic Agriculture 2013. Public Comment to NOSB. Docket AMS-NOP-12-0070

CFS Comments to the NOSB, 2015, Docket #AMS_NOP_15-0002-0874

CFS Comments to the NOSB, 2015. Reference List. http://www.regulations.gov/#!documentDetail;D=AMS-NOP-15-

0002-0875

National Organic Standards Board Materials/GMO Subcommittee. (2014). Discussion Document on Excluded

Methods Terminology. August 22.

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

organic farming.