1. To CSTA Biotech Committee November 9, 2016
Plant Breeding Innovation Consistent Criteria for the Scope of Regulatory Oversight
To CSTA Biotech Committee
November 9, 2016

2. Background
Differing definitions, legal frameworks and approaches around the world
How to move toward consistent policies for plant varieties developed through newer breeding methods
ISF Concept Paper, for use by NSA’s and RSA’s in discussions with regulators
Objective: To Achieve alignment among governments on the criteria used to assess whether plants developed through plant breeding innovations should be subject to regulatory oversight under existing Genetically Modified Organism(s) regulations for plants

3. Consistent Criteria
Goal: Consistent approach to the scope of regulatory oversight for products of plant breeding innovation
Agreement among countries on the criteria that would be used to determine the scope of regulatory oversight
Implementation of the criteria may be different across countries
ISF Concept Paper, for use by NSA’s and RSA’s in discussions with regulators

4. UNDERLYING PRINCIPLE
An underlying principle for determining the criteria: Plant varieties developed through the latest breeding methods should not be differentially regulated if they are similar or indistinguishable from varieties that could have been produced through earlier breeding methods.

5. CRITERIA
The genetic variation in the final plant product would not be covered under the scope of existing biotech/GMO regulations for plants if:
there is no novel combination of genetic material; or
the final plant product solely contains the stable insertion of inherited genetic material from sexually compatible plant species; or
the genetic variation is the result of spontaneous or induced mutagenesis.
Novel combination of genetic material means the stable insertion in the plant genome of one or more genes that are part of a designed genetic construct.

6. Next Steps
High interest in the concept paper among countries and allied groups
Interest in having paper translated (Chinese, Korean, Spanish, French)
Disseminate paper more broadly, but strategically
Positive dynamic in London and Paris meetings
Participants requested a third meeting
Third meeting
ISF sponsored or government sponsored?
Broader ministry involvement
Enlarge core group to include Canada (CSTA), Chile, and possibly Vietnam

7. Communication: Toolkit concept
Provide ISF members with guidance and tools to influence policy makers
FAQs: completed April 2016
Talking Points booklet: December 2016
PowerPoint presentation: December 2016
Infographics –short term needs identified
>> Resource bank – to be developed
Ultimately we want to influence policy makers in their decisions about the regulation of products of plant breeding innovation.
Policy makers may not necessarily understand the benefits of plant breeding innovation, the application of the technologies or the regulation.
We need our members to be able to explain these 3 elements to them (and regulators) in a language that they understand to help them to make the link.
Our target audience now is POLICY MAKERS.
Longer term, the target audience will expand to include the MEDIA > GENERAL PUBLIC