CropLife International New Plant Breeding Working Group

Position Document onRegulatory Oversight of Products Developed Through
New Breeding Techniques (NBTs)
CropLife International recognizes the importance of new techniques in plant breeding. In
most cases, NBTs are innovative improvements and refinements of traditional breeding
methods used to optimize plant health, nutritional quality and yield. They are key inenabling farmers to meet our planet’s future food demands by contributing towards efficientand sustainable agricultural practices which preserve our environment’s natural resources
and stimulate further innovation in plant breeding. CropLife International is concerned about
the unnecessary regulation of products developed using NBTs simply based on the breeding
technique employed and not the characteristics of the final products. In many cases, NBTs
result in products which are similar or indistinguishable from products developed throughtraditional breeding methods. Adding regulatory burdens based on the method used todevelop a product bears the risk of stalling innovative solutions without enhancing productsafety.

General Policy on New Breeding Techniques•CropLife International encourages all governments to adopt a globally harmonizedapproach towards NBTs, and avoid unnecessary regulation of products developed
through NBTs.

•Government policies should aim to foster innovation in vital sectors such as plantbreeding to increase food and feed production in a sustainable way.

•Regulations, if needed, should be based on sound scientific principles andproportional to the degree to which the product is creating new potential safetyconcerns to the environment or food chain, and not on the process by which it wasproduced. Small changes to plant genomes need to be viewed in light of inherentnatural variability of plant genomes.

•Governments should provide timely guidance to product developers on the regulationof NBTs. The regulation of plants produced by NBTs should be predictable in order forindustry and public research institutes to foresee appropriate investments andplanning for the development and commercialization of any regulated NBT products
in a reasonable time frame.

•Governments should avoid regulating products developed through NBTs that are
similar or indistinguishable from products resulting from traditional breeding
methods, since such products do not differ in their safety.

NBTs foster further innovation in plant breeding

Innovation is crucial in supporting continued developments in plant breeding. As more food,feed, fiber and fuel are needed to meet our global population demands, farmers are being

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required to produce more on the same land area, under ever-changing environmentalconditions. To meet these needs, innovations in plant breeding, including NBTs, continue toevolve to complement and enhance existing breeding techniques, allowing breeders andresearchers in the public and private sectors to increase the efficiency and specificity of plant
breeding. NBTs offer positive benefits to food security, environmental protection and global
agricultural sustainability by virtue of trait advancements which improve the agronomy,production and value of the crop for both the farmer and consumer.

Plant breeding has a long history of safe use

Plant breeding has been practiced since the beginning of human civilization. For several
millennia, farmers have domesticated crops through the selection of desirable plant traits
with the goal of developing crops for agricultural purposes and, ultimately, for increasing theproduction of quality food. Modern day maize, wheat and rice are dramatic examples of theeffect of human selection on agricultural crops. Through thousands of years of domesticationand selection of desirable agronomic and yield enhancing traits, today’s maize, wheat andrice are safe, robust, staple food crops capable of growing under a wide range ofenvironmental conditions and relied upon to feed a majority of the world’s population.
Plant breeding makes use of variations in plant genomes to develop new crop varieties tomeet the demand of farmers and consumers. Changes and variation in plant genomes are
ubiquitous and essential drivers for plants to adapt to their environment (Weber et al 20121,Winkler 20082) and have resulted in a wide variety of crops with a long history of safe use.
For example, over the past century, mutagenesis applications (radiation and chemicalmutagenesis) have resulted in over 3,2003 improved crop varieties which have been planted
and safely consumed in over 175 plant species including rice, maize, wheat, tomato, squash
and soybean. As a result of the long history and contribution to improved crop varieties,
mutagenesis is globally considered to contribute to the production of safe, reliable andsustainable crops.

Advancing agriculture through precision breeding

NBTs are currently used in plant breeding of major row crops such as maize and soybean,vegetables, commodity and specialty crops by both the private and public sectors. Compared
to traditional methods of inducing genomic changes (e.g. gene and chromosome
rearrangement, chemicals, radiation) that have a long history of safe use, but are random,
NBTs provide a high level of accuracy and precision to generate targeted changes atpredefined locations in plant DNA.
Currently NBTs include, among others, Oligonucleotide Directed Mutagenesis (ODM) andSite-Directed Nuclease (SDN) applications to make targeted DNA mutations which are more
precise and predictable compared to traditional mutational applications; RNA dependent DNA
Methylation (RdDM) which results in epigenetic modifications allowing for precision gene
regulation and expression without changing the DNA sequence of the plant genome; and the1Plant Physiol. 2012 160: 1842-1853.doi:10.1104/pp.112.204271. Natalie Weber, Claire Halpin, L. CurtisHannah, Joseph M. Jez,John Kough, and Wayne Parrott http://www.ilsi.org/FoodBioTech/Publications/Plant%20Physiol.-2012-Weber-1842-53.pdf
2Trends Plant Sci. 2008 Dec;13(12):640-6. doi: 10.1016/j.tplants.2008.09.004. Epub 2008 Oct 22.
Wijnker E, de Jong H. http://www.ncbi.nlm.nih.gov/pubmed/18948054
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http://www-infocris.iaea.org/MVD/default.htm

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Helping Farmers Grow2selective and efficient transfer of existing plant genes from wild relatives into modern
agricultural plant varieties (cisgenesis).
As science continues to progress, new plant breeding techniques will continue to evolve andemerge. Although these techniques may be considered new, the products developed throughthem are similar or indistinguishable (including at a molecular level) from existing products
developed using traditional breeding techniques. NBTs are simply innovative improvements
and refinements of existing breeding methods; designed to enhance the speed and efficiencyof breeding, with more knowledge and understanding than ever before.

NBT safety and regulatory perspective

As witnessed by the long history of safe use of plant varieties produced through humandomestication and breeding, the techniques used to develop new plant varieties do not posea specific safety hazard; it is the characteristics of the plant that determines its safety. Thus,
the need to regulate plants developed through NBTs should be driven by the characteristicsof the product (i.e., whether it is materially different from existing products present in food,feed or the environment) rather than by the production method or process used to producethat product.
An increasing number of plant varieties are being developed using NBTs in countries allaround the world by both the private and public sectors. As a result, NBT products may besubject to different regulatory requirements leading to differences in the regulation among
trading partners, and may result in potential trade issues and enforcement problems
globally. It is well understood that regulatory approaches have the potential to influence
perceptions of the hazard of technologies and products, unduly raise public concern andnegatively impact the global trade of goods produced through such technologies.
Like the private sector, public sector breeders and scientists have significant opportunities toemploy NBTs in their breeding programs, especially for minor crops, such as trees andvegetables. However, the adoption of these technologies by both sectors is highly dependent
on the regulatory requirements for products developed using NBTs.
Unnecessary regulation and oversight of such products, based on the method ofdevelopment, would result in undue, costly regulatory burdens, stifle innovation and preventthe uptake of scientifically advanced, innovative breeding applications by the public andprivate sectors. In addition, the regulatory status of NBTs will impact trade not only in seeds
but also in agricultural commodities derived from these seeds. Different government
approaches risk disrupting international commodity trade flows, particularly in a scenario
where various levels of regulation are applied to the same type of product, withasynchronous pre-market approvals.

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