new plant breeding techniques (npbts)
DESCRIPTION
COMPARATIVE REGULATORY APPROACHES FOR NEW PLANT BREEDING TECHNIQUES Maria Lusser, Emilio Rodríguez Cerezo European Commission, Joint Research Centre IPTS – Agrilife Unit, Agritech Action 16th ICABR Conference 26 June 2012, Ravello, Italy. New plant breeding techniques (NPBTs). - PowerPoint PPT PresentationTRANSCRIPT
COMPARATIVE REGULATORY APPROACHES FOR
NEW PLANT BREEDING TECHNIQUES
Maria Lusser, Emilio Rodríguez CerezoEuropean Commission, Joint Research Centre
IPTS – Agrilife Unit, Agritech Action
16th ICABR Conference 26 June 2012, Ravello, Italy
New plant breeding techniques (NPBTs)
• Breeding techniques which deploy biotechnology
• Developed during the last 10 (20) years
• Fall product derived through these techniques under the GMO legislation?
NPBTs discussed in the EU
1. ZINC FINGER NUCLEASE TECHNOLOGY
2. OLIGONUCLEOTIDE DIRECTED MUTAGENESIS (ODM)
3. CISGENESIS/INTRAGENESIS
4. RNA-DEPENDENT DNA METHYLATION (RdDM)
5. GRAFTING ON GM ROOTSTOCK
6. AGRO-INFILTRATION
7. REVERSE BREEDING
JRC Studies on NPBTs
JRC STUDY (2011, published 2012)Comparative regulatory approaches for new plant
breeding techniques
Workshop in September 2011
Represented countries: Argentina, Australia, Canada, European Union, Japan and South Africa
Regulatory framework for biotechnology derived crops
Regulatory approaches for NPBTs
Approaches and decisions for specific groups of NPBTs
Publications:
Pew Initiative on Food and BiotechnologyGuide to U.S. Regulation of Genetically Modified Foodand Agricultural Biotechnology Productshttp://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf
Tiptoeing around transgenicsEmily Waltz, Nature Biotechnology 30, 215-217 (2012)
Complementary information on the USA
•REGULATORY FRAMEWORK FOR BIOTECHNNOLOGY
DERIVED CROPS
EUROPEAN UNION
Regulatory system for GM crops since 1990
Amended in 2001
Expanded to food and feed in 2003
EUROPEAN UNION
GMO definition:
• Directive 2001/18/EC, Article 2 (2)• ‘Genetically modified organism (GMO)’ means an
organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.
ANNEX 1 A, PART 2
Techniques which are NOT considered to result in genetic modification such as in vitro fertilization, natural processes such as: conjugation, transduction, transformation and polyploidy induction
MUTAGENESIS
ANNEX 1 B
Techniques of genetic modification yielding organisms to be excluded from the Directive such as mutagenesis and cell fusion
RISK ASSESSMENT
TRANSGENESIS
ANNEX 1 A, PART 1
Techniques which are considered to result in genetic modification such as recombinant nucleic acid techniques, micro- and macro-injection and cell fusion
Directive 2001/18/EC
ARGENTINA, AUSTRALIA, JAPAN and SOUTH AFRICA
Specific regulatory systems for GMOs
Authorisation based on risk assessment required before use as food, feed, cultivation, import, etc.
GMO Definition in national law
In Australia and South Africa: Negative lists
CANADA
Products derived through biotechnology are to be
treated as any other novel product
Regulation is triggered by the novel trait of the product and not by the process by which the trait is introduced
Assessment of plants with novel traits (PNTs) is based on science and decided case by case
UNITED STATES OF AMERICA
USDA regulates under the Plant Protection Act the environmental release of certain genetically engineered organisms, which are, or are believed to be, plant pests
Permit or notification required for carrying out field trials
After field trials, petition for non-regulated status may be submitted
Accompanied by studies, data incl. results from field trials which demonstrate that there is no significant plant pest risk
•REGULATORY APPROACHES FOR NPBTs
EUROPEAN UNION (1)
• “WORKING GROUP ON NEW TECHNIQUES” (NTWG) - experts from Member States
managed by DG SANCO
• Evaluated whether NPBTs constitute techniques of genetic modification and
• Whether the resulting organisms falls under EU GMO legislation
• Evaluation started in 2008 • Report was finalised in January 2012 (not public)
EUROPEAN UNION (2)
• EUROPEAN FOOD SAFETY AUTHORITY (EFSA)
Mandate of DG SANCO in 2011 to address the safety aspects of NPBTs
Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis (2012)
Currently evaluation of ZFN and meganuclease technology
EUROPEAN UNION (3)
JOINT RESEARCH CENTRE (JRC)
2010 Study on “New plant breeding techniques: state-of-the-art and prospects for commercial development”
2011 Study on “Comparative regulatory approaches for new plant breeding techniques”
ARGENTINA
• A group of experts started to study the issue of NPBTs
• Discuss technique-by-technique
• Preliminary conclusions reached for most of the techniques
AUSTRALIA
• Developers are encouraged to contact the regulator with specific cases of crops derived by NPBTs where the regulatory status is not clear
• So far has not publicly given general guidance
• Intended to continue with this approach until more experience with NPBTs is aquired
CANADA
• Crops with novel traits have to pass assessment and authorisation process, independent of the technology used
• Example: Sulfonylurea tolerant canola produced by ODMTriggered legislation because of herbicide tolerance (issues to be taken into account: management of volunteers or emergence of herbicide resistant weeds)
JAPAN
• Officials from six ministries meet regularly for consulting and coordinating activities under the GMO legislation
• Collect information to NPBT crops and consider classification on a case-by-case basis
• No final conclusions have been reached so far
SOUTH AFRICA
• Experience with NPBTs limited to some research activities
• Initial considerations have started following the invitation to JRC workshop
UNITED STATES OF AMERICA
• USDA has been contacted by companies which are developing crops by NPBT (before field trials)
• Letters from USDA directed to companies were send stating that crops derived by certain techniques do not fall under USDA’s oversight (decision for techniqe or specific event)
• Some of these decisions are public (USDA website)
•APPROACHES AND DECISIONS FOR SPECIFIC GROUPS OF
NPBTs
GROUPS DISCUSSED
• GROUP 1: TARGETED MUTAGENESIS ZFN, ODM, Meganuclease technique
• GROUP 2: CISGENESIS AND INTRAGENESIS
• GROUP 3: TRANSGENIC CONSTRUCT DRIVEN BREEDING RdDM, Reverse Breeding
• GROUP 4: OTHERS Grafting on GM rootstock, Agro-infiltration
GROUP 1: TARGETED MUTAGENESIS
Zinc Finger Nuclease technology (ZFN 1-3)
Oligonucleotide directed Mutagenesis (ODM)
Meganuclease technique
REGULATORY DISCUSSIONS AND DECISIONS
ZFN-1 and meganuclease techniques wherby no template sequences are introduced will be most likely classified as non GM in most of the countries participating in the workshop
ZFN-3 or meganuclease technique whereby a long DNA sequence is introduced are recombinant DNA techniques (GMOs)
REGULATORY DISCUSSIONS AND DECISIONS
For ZFN-2, Meganuclease technique wherby short template sequences are introduced or ODM, it generally appears to be unclear which kind and size of change obtained should decide between GMO or non-GMO
• Argentina: most likely case-by-case decisions
• Australia: likely to be regulated as GMOs
• Other experts argued that products cannot be distinguished from products derived through mutagenesis induced by chemicals or irradiatoion- should be regulated in the same way)
Thank you for your attention