Alexandria Conference on Biotechnology and Sustainable Development:Voices of the South and North, 16. 3. 2002

Panel 9: Theme 3: Case Studies of International Experiences in Ethics, Food Safety and Environmental Safety of Biotechnology Applications

The Scientific Basis of Biosafety

Klaus Ammann (Switzerland)

Three types of risk. John AdamsTRANSGENIC PLANTS AND THE MANAGEMENT OF VIRTUAL RISKSeveryone takes risks;everyone is a risk manager; Science can reduce uncertainty by illuminating the connection between behaviour and consequence,science cannot provide objective measures of risk; Where scientists dont know or cannot agree virtual risks are cultural constructs;they may or may not be real Science cannot settle the issue they have real consequences;

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The Cow Pock or the Wonderful Effects of the New Inoculation! James Gillray (1757-1815) Photographic reproduction of an etching appearing in Vide--The Publications of ye Anti-Vaccine Society, June 12, 1802, National Library of Medicine

Karl Popper:

the most important feature of scientific knowledge is itsrevisability

There are severaldifferent kinds of knowledge:

- factual knowledge- traditional knowledge of the daily lifedeontic knowledge (what ought to be)- instrumental knowledge- conceptual knowledge etc.

Risk assessment of transgenes in organisms has been done extensively during the Asilomar Moratorium in safety labs for nearly ten years: Transgenic organisms show normal characters with the exception of the transgene function

Risk assessment of gene flow has been done with many experiments.

They show predominantly irrelevant reductionistic results of direct measurement of real transgene flow in short time conditions under very local aspects.Results are mixed and inconclusive

Dutch-Swiss Method takes into account realistic long term hybridization processes, always in the spirit of the precautionary principle

(a) Typical downwind deposition of corn pollen on greased microscope slides at ground level; measured after 9 h with no rain and light winds. Source: Raynor et al. (1972).

(b) Proportion of hybrid seeds of wild and crop sunflowers planted near each other; data from two sites. Source: Arias and Rieseberg (1994).

Potential Risk of Gene Flow to wild relatives for 19 Swiss crops:

Frequenc.

seed

Hybridization, pollen transport etc.

dispersal

0

1

2

3

4

5

0

0

1

tomato

2

tobacco

3

4

5

1

0

1

2

beet

3

4

5

2

0

1

2

endive

3

4

turnip

5

lettuce

3

0

1

2

cabbage

3

radish

4

5

rape

4

0

maize

1

barley

2

wheat

carrot

3

rye

chicory

4

5

5

0

1

potato

2

3

clovers clover

4

alfalfa

5

grasses

Risk assessment of ecological impact of transgenes needs enhancement, but first results show for the present day transgenes tolerable impact

Losey in Nature 1999: Bt pollen can kill 40% of monarch larvae within 4 days

Published online before print September 14, 2001 Proc. Natl. Acad. Sci. USA, 10.1073/pnas.211297698Corn pollen deposition on milkweeds in and near cornfieldsJohn M. Pleasants*, Richard L. Hellmich, Galen P. Dively, Mark K. Sears, Diane E. Stanley-Horn, Heather R. Mattila, John E. Fosteri, Thomas L. Clarki, and Gretchen D. Jones**Survival curves formonarch larvae placed in and near Bt-and non-Bt corn fieldsin a) Iowa, b) New York

Up to now transgene technique is basically a copying technique, where nature is mimicked, with the exception of breaking up species boundaries

Transgenes have their origin in nature

Classic breeding is a technique where integral gene packets are moved by hybridisation

Manipulation of Wheat Genetics

Pieces of chromosomes from several other species have been added

New traits gained through classic breeding techniques go directly into field trials Classic Selection is considerably speeded up by artificial mutagenesis (chemical agents or radiation) and e.g. by manipulating plastids

Gene flow is an important driving force of evolution in general

Totipotence: Generations of Plants grown out of ProtoplastsThrough manipulation of protoplasts it is possible to overcome species boundariesRisk balance

Institute of Radiation Breeding Ibaraki-ken, JAPAN http://www.irb.affrc.go.jp/100m radius

89 TBqCo-60 source at the centerShielding dike 8m high Gamma Field for radiation breedingBetterspaghettis, whisky1800 new plants

Gene flow is greatly enforced by urbanisationand classic agriculture

Escaped transgenes do not necessarily persistin interbreeding populations due to mechanismsof gene introgression

Escaped transgenes with ecological impact are in special situations unwelcome, but up to now also not documented

Beneficial insects suffer much more from pesticide sprays than from the transgenes of the Bt crops or from the loss or ill health of their prey: A call for balanced field studies

Soil microfauna and microflora is suffering from artificial fertilisers, heavy machines, to a limited extend also from pesticides and certain herbicides, but less through Bt from roots and plant residues: A call for balanced field studies

* 03.11.99

Soil fauna: Alopecosa sp. and Oedothorax apicatus

No difference

Reduction in abundanceafter insecticide treatment

After: M. Candolfi, NCP

_1002549582.doc

An example with soil organisms:

- similar, the majority of the organisms showed no difference in their abundance in the different plots,

- one example (a SINGLE ARTHROPOD species), showing the diminution in the abundance of the insect population, with no recovery, at least as long as the sampling proceeded.

* 03.11.99

Aerial fauna: Thrips sp. and Orius sp.

No difference

Time- limited reduction in abundanceafter insecticide treatment

After: M. Candolfi, NCP

Two examples of results, first with aerial arthropods: - one with no difference in the insect abundance between the various treatments,THE MAJORITY OF THE RESULTS WERE OF THIS TYPE.

However,- example of some decreased insect abundance on the plots treated with the chemical insecticide, just after the treatment (line), but the populations recovered, no difference at the end of the season.

traditional Roundup 100% Roundup 50%BeetreportDenmark2001NERI

Gene flow from crop to crop can normally best be managed through standard distances, which may vary from crop to crop and region by region

In other cases (e.g. colza with pharmaceuticals) need physical or biological containment

Tabelle1

Gene flow within Swiss crops

Cropbreeding systemhybridisation potentialHybridization

biologiein neighbouring fieldswith safety distance

crop for bred

Wheat, summer and winterstrictly autogamousvery unlikelyno/~20m

Ryeheterogamousvery likelyminimal/200-1'000m

Dinkel + other bred cropstrictly autogamousvery unlikelyno/~20m

crop for feed

corn for feedauto- and heterogamouspossibleno/~200m

barleystrictly autogamousvery unlikelyno/~20m

Oatheterogamousvery likelyminimal/200-1'000m

Triticalestrictly autogamousvery unlikelyno/~20m

bred wheat mixturestrictly autogamousvery unlikelyno/~20m

Potatoesno fertilization through pollenimpossibleno/0m

Sugar beetno fertilization through pollenimpossibleno/0m

Beet for feedno fertilization through pollenimpossibleno/0m

Gen Suisse, Bern, November 2000/KB

Tabelle2

Tabelle3

Male fertile plant of the maize hybrid Delprim on the left hand side, on the right hand side the male sterile version of the same cultivar. As can be seen from the vestigial inflorescence, the male sterile plant does not release pollen. Photograph by M. Long.

Risk assessment must be complete in each case of submission to the regulatory agencies

Risk assessment should in future be harmonised where possible and differentiated where necessary: Principle of familiarity, regionalisation of parameters depending on species and biogeography.

Scheme 1

Do viable fertile hybrids form between the crop and wild/weedy relatives ? Does the crop reproduce sexually ?

Yes or insufficient information

No

Does the crop have outbreeding potential with relatives in Switzerland ?

LOWER RISK

Go to scheme 2

Yes or insufficient information

No

Do the crop-relative breeding systems permit gene flow in and out ?

LOWER RISK

Go to scheme 2

Yes or insufficient information

No

Does the flowering period of the crop and weed/weedy relatives overlap, or nearly so ?

LOWER RISK

Go to scheme 2

Yes or insufficient information

No

Do crop and wild/weedy relatives share the same means of pollination ?

LOWER RISK

Go to scheme 2

Yes or insufficient information

No

Do crop and wild/weedy relatives naturally cross-pollinate, fertilize, and set viable , fertile seeds under field condition ?

LOWER RISK

Go to scheme 2

yes or insufficient information

No

Go to the ecological performance of transgenic wild/weedy plants.

(in case of an insufficient safety distance policy and in absence of biological containment policy stop development with risky transgenes

LOWER RISK

Go to scheme 2

Scheme 2

ASSESSING THE POTENTIAL FOR TRANSGENIC CROPS TO BECOME WEEDS

ASSESSING THE POTENTIAL FOR TRANSGENE FLOW TO PRODUCE WEEDS.

Is the parent crop weedy or does the crop have close relatives in Switzerland ?

Do viable, fertile hybrids form between the crop and wild/weedy relatives ? (See scheme 2)

No

Yes or insufficient information

Yes

No

Simplified ecological performance evaluation

ecological performance evaluation

COMPETITIVENESS CROP TO CROP

Does the transgenic plant outperform the nontransgenic plant in

population replacement experiments ?

LOWER RISK

Go to scheme 3

tritrophic levels

3 years replacement experiments in 3-5 growing areas and/or where wild relatives occur:

1. Net replacement rate

2. Seed bank persistence

3 years population replacement experiments in the full range of growing environment including field margins and/or where wild relatives occur:

1. Net replacement rate

2. Seed bank persistence.

No

Yes

No

LOWER RISK

Go to scheme 3

tritrophic levels

WEEDINESS

Is weediness increased in transgenic plants exhibiting enhanced performance ?

LOWER RISK

Go to scheme 3

tritrophic levels

Weediness field experiments : (Multiyear?) confined small-scale field tests in several environments.

Yes

No

HIGHER RISK reconsider

commercialisation

LOWER RISK

Go to scheme 3

tritrophic levels

Long term monitoring in all cases of first mass releases, balanced collaboration between research groups and producers where possible

(no streamlining of results according to prejudice on both sides)

Risk assessment researchers should have influence on decisions on future product lines

Figure 1 The performance of conventional (blue) and transgenic (red) crops in natural habitats. Survival is the fraction of seeds sown (or tubers planted in the case of potato) that produce mature plants at the end of the first growing season. Error bars, 1 s.e. Data are averaged over habitats and replicates within habitat. In no case did populations of either conventional or transgenic plants increase, and transgenic plants never persisted significantly longer than conventional plants. All populations of maize, rape and sugar beet were extinct at all sites within 4 years of sowing. Potato still survives at one site, 10 years after planting, but the survivors are all conventional.Transgenic crops in natural habitatsM. J. Crawley, S. L. Brown, R. S. Hails, D. D. Kohn, M. ReesNATURE | VOL 409 | 8 FEBRUARY 2001 |

Probability(Fix for a given constellation leadingto exposure) Toxicity (inherent) Components of RiskRisk can be managed by changing exposure!HazardPotential Exposure (manageable)Example: Bees in rapefield Toxicity of a.i. to bees: high Probability for bees in rape: morning lower than afternoon

Exposure is manageable through application timing R i s kEvaluating the Safety of Products

xy believes that appropriate post-commercialisation monitoring of genetically modified crops should be instituted on a case-by-case basis,

grounded on the results of a scientific risk assessment, and acknowledging the uncertainties that exist among the Public and regulatory agencies with regards to the environmental safety of modified crops

In January, however, Syngenta begantalks with the IRGSP and, according to one IRGSP official, has agreed in principle to match the Monsanto agreement. NATURE|VOL 416 |14 MARCH 2002 |www.

Our results demonstrate that there is a high level of gene flowfrom industrially produced maize towards populations of progenitor landraces. As our samples originated from remote areas, it is to be expected that more accessible regions will be exposed to higherand whether the relatively low abundance oftransgene introgression detected in the 2000 harvest cycle in Oaxaca will increase, decrease, or remain stable over time. MNATURE |VOL 414 | 29 NOVEMBER 2001 |

The results imply that, since the domestication of maize, teosinte and maize have remained relatively isolated in genetic terms(Doebley 1984; Lpez and Kato 1990), suggesting that they have had the opportunity to evolve independently. Nevertheless, the possibility of a low frequency of introgression is not completely discarded, given that maize and teosinte coexist sympatrically and form fertile hybrids in many regions.

Conclusion: (email of Dr. Pauli to Dr. Chapela from summer 2001)I would not consider such a faint band as a positive signal, unless a) it is repeated in 3-5 independent experiments, b) the fragment is sequenced, c) the absence of CMV is shown and perhaps d) a GMO-specific positive amplification is performed or e) amplification with a nested 35S (or GMO-specific) PCR system (which is more sensitive than the single PCR) is performed. Dr. Urs Pauli from the Swiss Federal Institute of Health who worked with his team for one week on the original Oaxaca samples he got from Dr. Chapela in March 2001

Dr. Chapela did not quote this work and did not refer in his Nature article on the doubts of Dr. Pauli

Hunde...

Gene Flow in Switzerlandbetween crops and their wild relativesin Switzerland

Df: Frequency Dd: Dispersal rate Dp: Hybridization

SCIENCE VOL 290, 15 DECEMBER 2000, Ecological Risks and Benefits of Genetically Engineered Plants L. L. Wolfenbarger1* and P. R. Phifer2

Source: WHO report Release of GM Plants in the Environment, Is it a Health Hazard ? Rome 9.2000

Source: WHO report Release of GM Plants in the Environment, Is it a Health Hazard ? Rome 9.2000

Proposal Franz Bigler,Agricultural Research Station, ReckenholzZurich, Switzerland Oct. 2000

Beneficial arthropods: average /30 plants (August 1995) Monsanto Company confidential

Beneficial insects belong to Anthocoridae, Nabidae, Coccinellidae, Staphylinidae, lacewings and spiders

*