Upload
others
View
4
Download
0
Embed Size (px)
Citation preview
Global development of GMOs,
and new breeding techniques
challenging biosafety regulations
ENCIBio/EBBio 2018
Vitória, ES, BRAZIL, 1-4 October 2018
by Bertrand Dagallier, OECD
I. Global development and use of GMOs, where are we?
– Plants
– Animals
2
II. New breeding techniques– Promising developments
– Challenge for biosafety
– In search for clarifying regulation; examples of country steps
III. International cooperation in biosafety– At OECD, with Brazil participation
Global Area of GM Plants, 1996 to 2017
= 3 to 4% of global
agriculture areas.
17 million farmers + families
= 65 million people (=0.8%
of global population)
4 crops
= 99.1% of total GM area
Other GM crops? 0.9% area for seven species only:
Alfalfa, Sugar beet, Papaya, Squash, Potato, Eggplant and Apple
No other major staple crops (rice, wheat, cassava…), and ~ no GM trees3
99.9% for 2 types of traits:
insect/disease resistance,
herbicide tolerance, or both
Global Adoption Rates (%) for main GM Crops, 2017
4
Areas of GM Crops by countries, 2017
24 countries have grow GM crops in 2017.28 countries few years ago, 26 in 2016 (Slovakia and Czech Rep. stopped planting last year)
ISAAA, 2017
5
Approved Events for GM Crops used in Food,
Feed, Processing, and Cultivation
6
Recent trends in biotech crops
• Stacked-traits varieties: 71% of the newly approved
events (ISAAA, 2017)
• New hosts: approved products of apple , safflower,
pineapple…
• Consumer-targeted traits: nutritional content (e.g.
golden rice…), non-browning, storage capacity…
• Abiotic stress traits: tolerance to drought, high salinity, flood…
• Products in R&D pipeline: greening-tolerant citrus, blight-resistant chestnut, biofortified banana,
high-oil-content micro-algae, etc. 7
1) Atlantic salmon• A domesticated fish reared for food production
• Fast-growing GM strain approved in several countries
• Reported to have hit the market in Canada
Current applications in GM Animals:
early stage
2) Mosquitoes Aedes aegypti /Anopheles gambiae
• Vectors of viruses for tropical diseases, incl.
dengue, yellow fever, Chikungunia, Zika, malaria
• Self-limiting GM strain approved in several countries and
(experimental-local) releases taking place = Brazil
• Possible application of gene drive
8
For agriculture
• Contribute to farmers’ income
• Increase crop productivity: participate in food security, &
sustainable balance in agriculture-pasture-forest
• New varieties might help adaptation to climate change
For environment
• Provide a better/healthier envir.: less pesticide applications
• Contribute to biodiversity preservation: no-tillage
For consumers
• Some less costly commodities/food/feed; will others to come?
• Reduce food waste
• Contribute to disease fighting: health improvement (mosquito)
GMOs benefits
9
• Fear of innovation/safety concerns by (urban) consumers
for which GM benefits seem far/not perceived: Are GMOs safe for my food? the environment?...
= science-based AND emotional AND ethical considerations
• Wish for increased protection. What could be the unintended
effects of GMOs in longer term?
• GMOs ‘in the hands of multinationals’, for ‘intensive’ agriculture
only = socio/economics considerations
• Green trends in (wealthy) societies, ‘traditional’ products,
eat&consume locally, ‘healthier’ diets
Recent example in media: glyphosate safety in question
GMOs perceived risks
10
• National biosafety/novel food-feed safety systems
in place to protect the citizens and living environment. Scientists and public opinion impacts legislation
• YES/NO/partial approvals of GMOs for production;
for use/consumption; or for both. On product-by-product basis.
• Diversity of national regulations,
incl. costly/complex/highly-demanding risk assessment and
approval process, control, labelling
• But harmonised approaches/some common
understanding/ regarding RA – incl. Basic RA principles developed by OECD/WHO/FAO, and
elements to consider for biosafety and food safety RA (e.g. OECD
‘Blue book’ (1986), Codex principles for food safety, OECD Consensus Documents)
Non-harmonised GMO biosafety regulations,
but common views on risk assessment (RA)
11
• Slow adoption of some GM species, limited expansion. Approval asynchronicity = trade disruption (incl. LLP issues)
• GM production of the ‘big 4 GM crops’ will continue as
providing key commodities at low cost; will others progress?
• Evolution in opinions with better-perceived benefits? health, climate change, industrial applications e.g. energy,
bioremediation…?
Non-harmonised GMO biosafety regulations
- Consequences
12
Researchers have long sought better ways to edit the genetic code in
cultured cells and organisms to:
• insert new genes (= ‘GMOs’)
• correct targeted genes
• activate or inactivate genes (knock-out)
in order to provide beneficial applications, from agricultural to biomedical.
GM and ‘newer’ Breeding Techniques
13
OECD Workshop on new plant breeding techniques (2014) Site Directed Nucleases (SDN)
Oligonucleotide Directed Mutagenesis (ODM)
Cisgenesis/Intragenesis
Reverse Breeding
RNA-directed DNA methylation (RdDM)
Grafting on GM-rootstock of wild-type scion
Agro-infiltration
Some use GMOs during the process, but not kept in the final product
OECD Workshop on high-throughput DNA sequencing in GM plant safety
assessment (2016)
OECD Conference on genome editing applications in
agriculture (2018); SDN and ODM mainly.
‘Precision-breeding’ techniques (Brazil Norm.Resol.16 -Jan. 2018)
New Breeding Techniques at OECD
14
Zinc-finger nucleases, ZFNsMeganucleases, homing endonucleases
TALENsCRISPR-cas
The four families of gene editors
TALEN: Transcription Activator-Like Effector Nucleases
CRISPR: Clustered Regularly Interspaced Short Palindromic Repeats 15
Properties of genome editing tools: faster,
cheaper
The four families of gene editors
Meganuclease(1985)
ZFNs(2003)
TALENs(2010)
CRISPR-cas(2012)
Number of proteins 1 2 2 1+1 RNA
Production difficult not very easy easy very easy
Cost of production 50 000 euros 5 000 1 000 10
Time needed for an experiment
months months weeks days
Oligonucleotide Directed Mutagenesis (ODM): an approach by which specific mutations can be introduced in a defined place in a plant genome. Works on
one DNA strain (not the pair). Then traditional breeding (filtering) processes to keep the desired mutation only.
16
Genome-edited products in R&D Pipeline -
Plants
1) Next generation waxy corn• Under development by Dow DuPont
• Deletion of the entire allele by SDN-1 via CRISPR/Cas9
• Reported to have improved the maize varieties faster with no linkage
drag compared to conventional breeding
2) Tomato with high-storage capacity• Under development by Tsukuba University (Japan)
• Substitution of one base pair in the relevant allele via CRISPR/Cas9
• Reported to have remained unrotten for 60 days, thereby possibly
enabling long-distance transport and reducing food loss
17
Genome-edited products in R&D Pipeline -
Animals
1) Hornless cattle• Under development by University of California - Davis
• Substitution in horn-growing allele via TALEN
• Eliminating the need to manually remove horns to protect human
handlers and other animals
2) Fast-growing porgy fish• Under development by Kyoto University (Japan)
• Knock-out of the allele restricting muscle growth via CRISPR/Cas9
• Reported to have grown 50% larger in body size
18
NBT Regulatory Challenges/Considerations
• Mixed situation across countries as to ‘if’ and ‘how’ various
genome-edited products should be regulated (SDN-1, SDN-2, SDN3…)
• Applicability of GMO regulation to these products often unclear
from legal definitions, and thus has to rely on interpretation
• Difficulty in implementation: e.g. detection and identification of
some genome-edited products
• Inadequacy in knowledge/evidence regarding risk and safety of
these ‘new’ products in particular
19
United States.USDA
- 2011: "Am I regulated?" process. Cases of non-regulated genome-edited plants and animals.
- 2017: Proposed change to current regulation; withdrawn in Jan. 2018 (public opinion).
- March 2018, Agr. Secretary statement: no regulation for gen. deletion of any size, single pair substitution and
null segregants (= not containing transgene in final product)
FDA - 2017 public comment process on reg. approaches for plants and animals. Underway for better clarification
EPA - Underway for better clarification
European Union.
- Discussions by scientists expert group since 2008 upon request by NLD; conclusion in 2012 that SDN-1, SDN-2 and
ODM are exempted from GMO directive, but no action taken by European Commission.
- 2015: Case brought to French court on GM law applicability to genome editing products; sent to Court of Justice of
the European Union. Jan 2018, CJEU Advocate General advised for non applicability for techniques non involving
rDNA or GMOs
- July 2018, CJEU stated that only organisms obtained by conventional mutagenesis are excluded from GMO
directive, thus no exemption for gene-edited products.
- How to apply it?
Seeking for clarifying NBTs regulations: examples (1)
20
Canada.
Novelty trigger continues to apply to the products of NBTs. Therefore no specific consideration, conventional breeding
products, GMOs and genome-edited products are considered in the same way.
Japan.
- Aug. 2018: following discussions among Ministries, expert meeting conclusion that SDN-1 genome-edited products
might be exempted from biosafety law, but future reporting requirement to be developed
- Public consultation underway. Decision by Ministry of Environment expected early 2019.
- Similar process to start for the food products derived from genome-edited organisms.
Seeking for clarifying NBTs regulations: examples (2)
21
Australia/New Zealand.
Australia OGTR
- 2016/2017: Public consultation process on 4 options of approach to genome-edited products
- Public consultation underway on proposed changes to regulation: SDN-1, null segregants and RNAi products
might be exempted from gene technology act; decision to be taken by OGTR
New Zealand- EPA
- 2012: a genome-edited pine tree exempted from requirement of Hazardous Substances and New Organisms Act
- 2013: decision challenged by env. NGOs, and Court declared nullity of the decision. Regulation amended for
all biotech products developed after HSNO Act are treated as GMOs.
Australia/New Zealand- FSANZ (incl. novel food & feed safety)
- 2017: public consultation process on regulatory approaches; report under preparation. Decisions on future actions to
be taken by FSANZ
Seeking for clarifying NBTs regulations: examples (3)
22
Seeking for clarifying NBTs regulations: examples (4)
23
Seeking for clarifying NBTs regulations: examples (4bis - Australia)
23
Argentina.
- 2015 Resolution on NPBTs: For final genome-edited products not containing any transgene, then non
regulated as GMOS. But early consultation with the biosafety Authority CONABIA is required.
- Many contacts taken by Argentina (exporter) with other (importing) countries for seeking clarification and mutual
exchange of information. Active follow-up of the moving/quickly evolving situation in the different regions of the world.
Seeking for clarifying NBTs regulations: examples (5)
24
Extract from Dr. M. Lema/Argentina presentation
at OECD Conference on genome editing, June 2018
Brazil…
Seeking for clarifying NBTs regulations:
examples (4)
25
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)
26
Purpose:
Assist countries to evaluate potential risks of biotech. products
for human-animal health and environment 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
27
“Consensus” and Guidance Documents
- to help national assessment and decision-making process
- practical tools for comparing conventional and “GE” products
- Scientific information, internationally-recognised, a common basis;
however NOT prescriptive
- available online
OECD Biosafety Work Main Outputs
Exchange/cooperation
between biosafety Authorities (incl. Brazil as OECD ‘Key partner’)
on current and new issues – meetings, workshops, other events
Database
on G.E. products approved for release in the environment and/or food
and feed use (incl. Brazil) – 285 entries, 17 plant species – available online
28
Consensus document: outputs
29
Environmental Safety
Environmental Considerations (incl. Brazil)
Molecular characterisation
Low level presence (incl. Brazil)
New Plant Breeding Techniques
General documents on ES work
8 Microorganisms
5 Traits introduced
Information on
19 Crop plants (cassava, cowpea, common bean…)
13 Trees
3 Fruits
1 Mushroom
2 Animals (Atlantic salmon, mosquito Ae. aegypti;
coming A.gambiae)
Biology of
Food/Feed Safety
Animal feedstuffs
Emerging feed ingredients?
General documents on F/F S work
17 Crop plants (cassava, common bean…;
coming soon: cowpea)
2 Mushrooms
1 Fruit
Composition on
OECD Biosafety and Food/Feed Safety team:
Peter Kearns, Bertrand Dagallier, Ryudai Oshima, Yoko Takasu, Emily Seftel
Consensus Documents & Product database available at:
www.oecd.org/biotrack
Thank you!