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)
• 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
Complementary information on the USA
Publications:
 Pew Initiative on Food and Biotechnology
Guide to U.S. Regulation of Genetically Modified Food
and Agricultural Biotechnology Products
http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/
Reports/Food_and_Biotechnology/hhs_biotech_0901.pdf
 Tiptoeing around transgenics
Emily Waltz, Nature Biotechnology 30, 215-217 (2012)
• 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.
Directive 2001/18/EC
ANNEX 1 A, PART 1
ANNEX 1 A, PART 2
ANNEX 1 B
Techniques which are
considered to result in genetic
modification such as
recombinant nucleic acid
techniques, micro- and macroinjection and cell fusion
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
Techniques of genetic
modification yielding
organisms to be excluded
from the Directive such as
mutagenesis and cell fusion
TRANSGENESIS
RISK
ASSESSMENT
MUTAGENESIS
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 ODM
Triggered 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