public research & regulation initiative

Public Research & Regulation InitiativeMalaysian Biotechnology Corporation (MBC) and Malaysian Biotechnology Information Centre (MABIC) August 13, 2007

Prof. em. Klaus AmmannMember Steering Committee PRRI Delft University of Technology, NetherlandsKUALA LUMPUR

Roster of Experts Cartagena Protocol: 487

Mailing list International Society of Biosafety Research: 592

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PRRI – Background (continued)

(Data from 2004)

University Professors

Public Research & Regulation Initiative

Phase 1: 2004-2005: ‘Raising awareness’:

Phase 2: 2005 – 2006: ‘Try out’ Involvement of public research sector scientists in MOP2 and MOP3 of the Biosafety Protocol

Phase 3: 2006 - onwards: ‘Cruise control’ Multi year, organised involvement of the public research sector in relevant international negotiations

Phase 1: Raising awareness

Presentations in international meetings: BioAlexandria, (April 2004, Egypt) IPBO Course (August 2004, Belgium) ABIC 2004, (September 2004, Germany) 8th IBRS, (September 2004, France) 'Plants for the Future', (October 2004, Belgium) NAS ‘Global Challenges’ (October 2004, USA) GMO Guidelines project (January 2005, Switzerland) Conf. Plant Made Pharmaceuticals (Feb. 2005, Canada) PRRI Introductory Seminar (March 2005, Danforth Centre,

USA)

Phase 2: Try out participation in MOP2 and MOP3 MOP2: June 2005, Montreal

Preparatory meeting, weekend before MOP2 Participation in MOP2, 30 May – 3 June 2005 (30 PRRI

participants)

MOP3: March 2006, Brazil

Preparatory meeting, weekend before MOP3 Participation in MOP3, 13 – 17 March 2006 (40 PRRI

participants from 25 countries in Africa, Asia, Central and Eastern Europe, Latin America, Western Europe and North America and from several international organisations)

Approaches for participation in MOPs

Make interventions Hold meetings with other delegations Hold side events and attend side events

of others

Informal discussions with delegates

Conclusions from the ‘try out’ phase

Public researchers have become aware of the need to participate in international negotiations and are prepared to invest time and resources.

PRRI’s participation in negotiations is effective and appreciated. PRRI has become a well recognized entity.

PRRI will participate in MOP4 and COP9 (2008, Germany) and in the preparatory meetings.

PRRI will start participating in other international negotiations, such as the Aarhus Convention, Codex Alimentarius Commission

Phase 3: 2006 onwards 2006 – 2009 support from the European Commission

Structured organisation: Forum (almost 200 scientists), Steering Committee, Working groups (13) Secretariat.

Publications: newsletters, website, fact sheets, Q&A, position papers, briefing papers, myth busters etc.

IFPRI-PRRI database on public research

Myth Buster: > 100 items 1. General (examples) Modern biotechnology is inherently different from conventional

breeding and therefore poses greater risks. GMO-crops are inherently linked to big scale industrial agriculture,

they cannot be grown in small structure farming Genetic engineering cannot be tolerated within the strategies of organic

farming for scientific reasons Genetic engineering is not precise, there is no way of telling where the

genes will be implemented in the genome and what harm will be done. (Latham, Steinbrecher reports)

We don't know GMOs are safe on the long run, because there are no long term studies.

Horizontal gene transfer can occur between GM crops and microorganisms and therefore transgenes will soon be out of control

Epigenetic effects are a great and unexpected hazard of transgenic crops

Myth Buster: > 100 items 2. Food safety (excluding agronomic food security), examples Comparison food derived from GM crops, organic and conventional crops GM is less healthy than conventional or organic food Meat, milk, and eggs from livestock and poultry reared with biotech feed are

not as safe as when fed with conventionally produced feed. Foods developed using biotechnology do not have the same nutritional value of

comparable foods developed using traditional breeding. Whole foods developed using biotechnology contain genes, while foods derived

from traditional plant breeding do not. The transgenic DNA is taken up by bacteria in the human gut. Only transgenic crops have potential health problems (Lenape potatoes, Citrus

fruits) Lack of information Safety tests of biotech foods conducted or sponsored by biotech companies are

lacking scientific rigor, unreliable and self-serving. Only 10 peer-reviewed articles are published on the health effects of GM food

(GAIN Report)

Myth Buster: > 100 items 4. Impact of GM crops on evolution and environment (examples) GM crops are not natural, we should not play God and change

evolution Genetic engineering is on the molecular level a clear novelty and

cannot be compared at all with natural mutation GM crops are less well adapted to the local environment than

local landraces GM crops are not adapted to small scale farming GM crops cause alarming disturbances in the genome, they will cause

unknown long-term risks GM crops have inherent new epigenetic effects which are a

threat to health and environment Horizontal gene transfer occurs between microorganism and GM crops Pesticide/herbicide increase Widespread planting of herbicide-tolerant crops will lead to increased

use of harmful herbicides and the development of herbicide-tolerant weeds (Benbrook reports)

Myth Buster: > 100 items 5. Public perception, consumers concerns and regulation (examples) No GM food on shelves existing in Europe Having foods produced through biotechnology on grocery store shelves will not

be a reality for many years. Foods derived from GM crops are introduced in the human food chain without

proper safety tests. European opposition U.S. consumers are opposed to biotechnology in food production. The European Parliament and many European countries are winning the fight

against GMOs The WTO case against the EU was just political machination and of no real

significance. Consumers around the world have rejected GMO foods, especially in Europe.

Nobody wants to buy biotech crops. The public is either for or against GMOs The public is irrational and unscientific and cannot understand the controversy BSE ‘amalgam’: Resistance against green biotech is a clear follow-up of the

BSE affair in England

Interestingly, naturally occurring molecular evolution,i.e. the spontaneous generation of genetic variants hasbeen seen to follow exactly the same three strategies as those used in genetic engineering14. These three strategies are (after W. Arber, Nobel Laureate 1978)

(a) small local changes in the nucleotide sequences,

(b) internal reshuffling of genomic DNA segments, and

(c) acquisition of usually rather small segments of DNAfrom another type of organism by horizontal gene

transfer.Arber, W. (2002) Roots, strategies and prospects of functional genomics. Current Science, 83, 7, pp 826-828 http://www.botanischergarten.ch/Mutations/Arber-Comparison-2002.pdf

Arber, W. (2002) Roots, strategies and prospects of functional genomics. Current Science, 83, 7, pp 826-828 http://www.botanischergarten.ch/Mutations/Arber-Comparison-2002.pdf

On the molecular level, according to Arber no difference between natural mutation and genetic engineering (GE)

http://www.botanischergarten.ch/Mutations/Arber-Comparison-2002.pdf


However, there is a principal difference between the procedures of genetic engineering and those serving in nature for biological evolution. While the genetic engineer pre-reflects his alteration and verifies its results, nature places its genetic variations more randomly and largely independent of an identified goal.After ca. 10 years of testing the GM crops are brought to the field by millions in a few years



Whereas natural mutation works at random, GE works in a targeted way, and results will be distributed much faster to the fields



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Shewry: comparison in genomic disturbance: GM crops are less disturbed (black dots) than classic breeds

http://www.botanischergarten.ch/Organic/Shewry-Performance-2006.pdf

Ghatnekar, L., Jaarola, M., & Bengtsson, B.O. (2006) The introgression of a functional nuclear gene from Poa to Festuca ovina. Proceedings: Biological Sciences, 273, 1585, pp 395 - 399 http://www.botanischergarten.ch/Mutations/Gathnekar-Transgen-Festuca.pdf

Natural transgenic plant: Festuca, a widespread grass received a functional nuclear gene from Poa (not hybridizing with Festuca).

Chairman: Em. Prof. Marc van Montagu, Institute for Plant Biotechnology for Developing Countries (IPBO), Belgium

Members: Dr. Nevena Alexandrova, Agrobioinstitute, Bulgaria Prof. emerit. Klaus Ammann, University of Bern Moderator ASK-FORCE; Chair

Section Biodiversity EFB, Switzerland Dr. Roger N. Beachy, Donald Danforth Plant Sience Center, United States Prof. Yaroslav Blume, Institute of Cell Biology and Genetic Engineering, Ukraine Dr. Premendra D. Dwivedi, Food Toxicology Div Industrial Toxocology Research

Centre, India Dr. Ismail El Hadrami, Laboratoire de Physiologie Végétale, Marocco Dr. Christian Fatokun, International Institute of Tropical Agriculture (IITA),

Nigeria Prof. Behzad Ghareyazie, Strategic Research Center of Iran, Iran Willy de Greef, Institute for Plant Biotechnology for Developing Countries (IPBO),

Belgium

Steering Committee

Steering CommitteeMembers: Prof. Jonathan Gressel, Plant Sciences Weizmann Institute of Science, Israel Dr. Desiree Hautea, University of the Philippines, The Philippines Prof. Calestous Juma, Kennedy School of Government at Harvard University,

United States Prof. Julian Kinderlerer, University of Cape Town, South Africa, Dr. Charles Mugoya, The Association for Strengthening Agricultural Research in

Eastern and Central Africa (ASARECA), Uganda Prof. Magdy Madkour, Arid Land Agricultural Research Institute (ALARI), Ain

Shams University, Egypt Dr. Zaida Lentini, International Center for Tropical Agriculture (CIAT),

Colombia Dr. Susana Sirvas-Cornejo, Universidad Nacional Federico Villarreal, Peru Dr. Natalia Stepanova, Centre Bioengineering of the Russian Academy of

Sciences (RAS), Russia Prof. Paul S. Teng, Nanyang Technological University, National Institute of

Education, Singapore Dr. Arnoldo Khaleel Ventura, Office of the Prime Minister, Jamaica

Working Groups Public Sector Research in Modern Biotechnology

(IFPRI-PRRI database) Cartagena Protocol on Biosafety & CBD EC Directives and Regulations Aarhus Convention Liability Risk Assessment GURTS (Genetic Use Restriction Technologies) GM Trees IPR-ABS-PGR Communication – Public Perceptions Field Trials Future Issues Outreach to non-English speaking public researchers

Funding

Governments European Commission International organisations Private sector

PRRI funding is published on PRRI web site

Collaboration with other organisations Memoranda of Understanding:

FARA BSBA IFPRI

Under discussion: EFB ISBR ABSF ANBio

Public Research & Regulation Initiative

www.pubresreg.org

PRRI 2007-2008 activities

Main focus:

Participation in MOP4 (CPB) and COP9 (CBD) in May 2008,

Germany

Biodiversity Convention and Biosafety Protocol

Convention on Biological Diversity (1992): Aim: Conservation and sustainable use of biological

diversity, and fair and equitable sharing of the benefits of using genetic resources, including by access genetic resources and transfer of technologies

Article 8 (“In situ conservation of biodiversity” ): Obligation to develop National Biosafety Systems

Article 19 (“Handling biotechnology and distribution of its benefits”):- promote and advance priority access to biotechnology - Consider a protocol on biosafety – this became the CPB

Governing body: Conference of the Parties (COP)

PRRI 2007-2008 Activities

PRRI regional preparatory meetings

Africa, in collaboration with FARA and AfricaBio (in conj. with FARA Science Week 11 June 2007, Johannesburg, S.A.).

Western Europe: in collaboration with the EFB (in conj. with ECB, 17 September 2007, Barcelona, Spain).

North America, in conj. with international seed meeting, 17 September 2007, Davis, California.

Latin America: in collaboration with ANBio, in conj. with the V Biosafety Congress, 21 September, Belo Horizonte, Brazil.


PRRI regional preparatory meetings under discussion:

Eastern Europe: in collaboration with the BSBA (November 2007).

South East Asia: collaboration with IRRI and APEC (Late 2007)

Middle East - Central Asia: in collaboration with ICARDA (Late 2007 / Early 2008).


PRRI Participation in inter-sessional meetings

Ad Hoc Open-ended Working Group of Legal and Technical Experts on Liability and Redress in the context of the Protocol, 19-23 February 2007, Montreal, Canada

Fourth meeting of the Liaison Group on Capacity-building for Biosafety, 26 February - 2 March 2007, Lusaka, Zambia.

The Second International Meeting of Academic Institutions and Organizations Involved in Biosafety Education and Training, 16 - 18 April 2007, Kuala Lumpur, Malaysia

Canada Norway Expert Workshop on Risk Assessment for Future Applications of Modern Biotechnology, 4-6 June Montreal, Canada

Twelfth meeting of the Subsidiary Body on Scientific, Technical and Technological Advice, 2- 6 July 2007 - UNESCO, Paris, France.


PRRI Participation in inter-sessional meetings

PRRI plans to participate in: CBD - Ad Hoc Technical Expert Group on Technology Transfer

and Scientific and Technological Cooperation, 10-12 Sep 2007, Geneva, Switzerland.

Meeting of the Biosafety Clearing-House Informal Advisory Committee (BCH-IAC), 4-5 Oct 2007, Montreal, Canada.

Fourth meeting of the Ad Hoc Open-ended Working Group of Legal and Technical Experts on Liability and Redress in the context of the Protocol, 22 - 26 October 2007, Montreal, Canada.

Public Research in Agricultural Public Research in Agricultural BiotechnologyBiotechnology

DatabaseDatabase

PRRI – IFPRI TeamPRRI – IFPRI TeamKlaus Ammann*, Mulugeta BayehKlaus Ammann*, Mulugeta Bayeh++, , Jose Falck-ZepedaJose Falck-Zepeda++, ,

Mike May**,Mike May**,Kim Meulenbroeks*, Kim Meulenbroeks*, Patricia ZambranoPatricia Zambrano++

**Public Research and Regulation Initiative Public Research and Regulation Initiative ++International Food Policy Research InstituteInternational Food Policy Research Institute

Program For Biosafety SystemsProgram For Biosafety Systems**Institute of Plant Biotechnology for Developing **Institute of Plant Biotechnology for Developing

Countries Countries **

MOP4 - Risk Assessment and Risk Management

PRRI statements:

based on sound science – i.e. based on scientific reasoning, verifiable and replicable; no ‘fear for flying pigs’

Comparative – i.e. any risks identified in the risk assessment have to be compared with the risks of using the non modified recipient organism;

Information should only be requested if it is clear how it will be used in the risk assessment;

Address explicitly uncertainty - The precautionary approach does not mean ‘zero risk’

Address explicitly the potential benefits.

Risk Assessment – MOP4

Issue: need for development of new guidance for future applications of modern biotechnology, e.g. GM Fish, GM Trees, Plant Made Pharmaceuticals, GM vaccines ?

PRRI: The general principles and methodology for risk

assessment in Annex III of the CPB are equally applicable to ‘new’ GMOs - on a case by case basis.

Within the framework of Annex III, specific information and specific risk management considerations may apply to these new cases.

MOP4 - Risk Assessment and Risk Management

MOP4 - Biosafety Clearing House (BCH)

PRRI statements

the BCH is of crucial importance for public researchers if they need to know which procedures apply and whom to approach in a certain country.

many Parties have not yet complied with their obligation to place relevant information on the BCH, This is a serious hindrance to public research.

Placing such information on the BCH is not onerous but rather requires a couple of hours at a computer.

MOP4 - Socio-economic considerations

PRRI statements:

The socio economic considerations in decision making on the application of modern biotechnology need to include the socio-economic benefits of modern biotechnology, including alleviation of poverty and hunger.

MOP4 - Liability and Redress

Liability and Redress Issue: elaboration of international rules and procedures for

L&R

Options: legally binding vs. guidelines a civil liability regime, an administrative approach, a

trans-national regime, a dispute settlement mechanism

PRRI proposal: guidelines for an administrative system

MOP4 - Review of the functioning of the Protocol.

PRRI It is important to start shaping the parameters of

the assessment process, and it is crucial that an assessment be made of the impacts of the implementation of the Protocol on public research.

Suggestions for consideration in the review: special provisions for confined field trials, defining categories for exemptions ex article 7.4 Guidance on how to take into account in the

decision making process the benefits of biotechnology

COP9 - GM Trees

PRRI statements

Because of the numerous and diverse potential benefits from GM trees, the PRRI believes that it is essential to not only maintain, but indeed to intensify, biotechnology research in trees to help address societal challenges such as those mentioned above.

Because many of the processes of interest in trees cannot be readily studied in the laboratory or greenhouse, the ability to conduct field research is essential.

COP9 - GURTS

PRRI Statements

Gene-switching is a natural process in living organisms. GURTs is gene switching that control plant reproduction.

Public researchers are investigating the application of these technologies, for example to produce in plants vaccines for dangerous diseases such as foot and mouth disease. Other possible applications are presented on the PRRI web site.

These technologies are still in early stages of development, and that any assessment of the potential benefits and risks should be made on a case by case basis .

Precautionary principle vitamins

one track minded

Distorted Risk Perception

Miss my lung

public research & regulation initiative

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