This presentation highlights OECD's activities related to modern techniques of biotechnology including genome editing in light of previous OECD conferences and workshops and technical products, such as consensus documents.

1. An Overview of OECD
Activities Related to Modern
Techniques of Biotechnology
and Genome Editing
OECD Conference on Genome Editing, June 2018
Presented by Peter Kearns on behalf of OECD

2. 1) ENVIRONMENTAL safety of GEOs (biosafety)
Working Group for the Harmonisation of Regulatory
Oversight in Biotechnology
2) FOODS/FEEDS derived from GEOs
Working Group for the Safety of Novel Foods and
Feeds
OECD Bio&Food safety work: 2 programmes
Aim: Help to address human health and environmental safety issues, through
science-based risk assessment, for products of modern biotechnology
(G.E.O.s): plants, animals, micro-organisms
These groups are composed of bio/food safety
National Authorities: regulators, risk assessors &
experts, (and observers from Organisations)
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3. Purpose:
 Assist countries to evaluate potential risks of modern
biotech. products for human-animal health and environment,
and ensure high standards of safety
 Limit duplicative efforts: mutual understanding, acceptable
data
 Reduce the potential for non-tariff barriers to trade
OECD Biosafety Work Basic Principles
Means:
Harmonisation of approaches and regulatory frameworks
Share/disseminate common base of scientific information
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4. “Consensus” and Guidance Documents
- to help national assessment and decision-making process
- practical tools for comparing conventional and “GE” products
- available online
OECD Biosafety Work Main Outputs
Exchange/cooperation
between biosafety Authorities on current and new issues – meetings,
workshops, other events
Database
on transgenic products (approved for release in the environment
and/or food and feed use) – available online
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5. Consensus documents
Is this new food-feed as safe as its
conventional counterpart?
OECD docs collate key composition
elements on foods and feeds issued from
G.E. organisms, with compiled data, for
possible comparison.
The elements are considered --and
completed-- at national level.
Environmental Safety
Consensus Documents
Food/Feed Safety
Consensus Documents
On which features should my
environmental RA be based on?
OECD docs provide info. on what should be
considered for risk assessment of G.E.
organisms to be released in the environment.
The elements are considered --and
completed-- at national level.
 Scientific information reference, internationally
recognised, a common basis
 However NOT prescriptive (= not a compulsory standard)
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6. Consensus document: outputs
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Environmental Safety
Environmental Considerations
Molecular characterisation
Low level presence
New Plant Breeding Techniques
General documents on ES work
Microorganisms
Traits introduced
Information on
 Crop plants
 Trees
 Mushrooms
 Fruits
 Animals (coming soon)
Biology of
Food/Feed Safety
Animal feedstuffs
Emerging feed ingredients?
General documents on F/F S work
 Crop plants
 Mushrooms
 Fruits
 Atlantic salmon
 Aedes aegyptii
Composition on

7.  Contains Information related to
G. E. Products (Unique Identifier, parental
crop, introduced trait, developer name…)
Approvals (approval date, usage type,
authority name, link to decision/risk
assessment…)
 Information provided on a voluntary basis by
biosafety National Authorities;
 Validated and uploaded by OECD Secretariat
Product Database - Content
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8. Gene Editing
in the Directorate for Science,
Technology and Innovation
(OECD STI)

9. ‘Gene Editing in an International Context: Scientific, Economic and
Social Issues across Sectors’
BNCT Workshop on Gene Editing
• 29th – 30th September 2016, Ottawa, Canada
• Attendees from 14 countries, industry,
academia, and pressure groups
• Objective:
– Information exchange and cross-disciplinary
discussion on the science, governance, and
economics of gene editing innovations in:
• Applications in Agriculture
& Aquaculture
• Environmental Applications, and
• Applications in Human Medicine

10. Applications of Gene Editing (1)
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Current Applications:
•Health / Medicine:
– Fast, targeted breeding of mouse models (e.g. 2 years shortened to 4 months)
for advanced understanding of the roles of specific genomes and cures for
genetic disorders, or for fertility studies with human embryo cells (cf. Francis
Crick Institute, UK, February 2016)
– Study of the gene-editing tool itself (i.e. safety issues, off-target effects, efficacy,
etc.) (cf. China, April 2015)
– Trials to eradicate malaria-transmitting mosquitos (by making them infertile /
preventing mating / infecting them with bacteria / etc.)
•Agriculture:
– Fast, targeted breeding of plants with special resistances (e.g. drought
resistance), or with special abilities (e.g. self-fertilization or self-pollination), or for
special purposes (e.g. therapeutic applications)
•Environment:
– Studies to inhibit the spreading of invasive species (e.g. farmed salmon)

11. Applications of Gene Editing (2)
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(potential) Future Applications:
•Health / Medicine:
– Treatment of diseases (i.e. by elimination of genetic mutations that
cause a disease, or by modification of human somatic (i.e. non-
reproductive) cells): HIV/Aids, haemophilia, sickle-cell-anaemia,
some cancers, etc.
– Elimination of heritable genetic diseases from a family line (i.e. by
KO- or repair of the human germ line in embryonic cells)
• Agriculture:
– Fast, targeted and ‘cheap’ breeding of plants
and animals with specific desirable attributes
(cf. super-muscly pigs created by deleting
a gene, which inhibits muscle growth,
versus the Belgian Blue beef bred through
traditional breeding techniques)
Taken from: http://www.nature.com/news/super-muscly-pigs-created-by-small-genetic-tweak-1.17874
“Super-muscly pigs created by small genetic tweak.” (Nature 523 (2015) 13-14).

12. For more information on
For more information on
OECD Gene Editing Activities:
OECD Gene Editing Activities:
Please see the
Please see the poster in the foyer
poster in the foyer

13. Genome editing Conference web site:
www.oecd.org/environment/genome-editing-ag
Thank you!