RCGM Submission from PSRG (PSGR)

Submission to the New Zealand Royal Commission on Genetic Modification

4. Name of Organisation/Person accorded “Interested Person” Status.

Physicians and Scientists for Responsible Genetics New Zealand - Charitable Trust

Physicians and Scientists for Responsible Genetics New Zealand - Charitable Trust, (PSRG), is a national body of principally health and scientific professionals who have grave concerns about particular aspects of genetic engineering biotechnology. Although PSRG feels that fundamental research into these and other aspects of molecular biology are important to New Zealand, they advise that the present loose regulatory Act should be examined more closely.

In this submission PSRG provides an overview of its concerns about genetic engineering and focuses on the significant dangers that exist now and will in the future from the use of this technology. The detail is contained within the witness briefs that accompany the submission.

NB - The use of the term GENETIC ENGINEERING in our Submission: Genetic modification is a public relations term. Throughout this submission we shall use the scientifically correct term of genetic engineering as recommended by the Royal New Zealand College of General Practitioners’ Environmental Working Party.

5. Submission Executive Summary

Executive Summary

Provide an overarching summary of your submission and recommendations made [in respect of items (1) and (2) of the Warrant].

(1) the strategic options available to enable New Zealand to address, now and in the future, genetic modification, genetically modified organisms, and products: and

(2) any changes considered desirable to the current legislative, regulatory, policy, or institutional arrangements for addressing, in New Zealand, genetic modification, genetically modified organisms, and products:

Limitations of molecular biology and genetic engineering (GE)

It is important to realise and stress the extent to which genetic engineering is an imprecise, unpredictable and inherently hazardous technology. Splicing foreign DNA into an organism's genome can and has caused disruptions in the behaviour of one or more original genes. Further, it is not possible for biotechnicians to reliably predict what specific changes will occur in the case of any given instance. Furthermore, to enable the foreign genes to function in the host genome they are regularly fused to promoters from viruses or bacteria which cause them to operate independently of the host organism's complex regulatory system. The presence of these powerful promoters can also change the expression levels of the native genes. Due to such factors the resulting products could be rendered toxic, allergenic or otherwise harmful to human or other consumers (including animals, birds, insects, essential soil microflora, etc.).

Indeed, it is well-known that toxins or other harmful substances have been generated that are not ordinarily present in either the host species from which the transferred genetic material is taken or the species into which it is implanted. (See Witness Brief Dr Neil Macgregor on soil and R. Anderson on GE food.)

2. Many respected world scientists see the imprecise methods of genetic engineering as encouraging inserted genes to interact with bacteria or viruses with alarming possible side-effects. At this stage we do not know the odds of this occurring, but the possibilities are inherent in the process. We therefore feel that genetic engineering biotechnology is inherently hazardous. Splicing foreign DNA into an organism's genome can and has caused unpredictable disruptions in the behaviour of one or more native genes. Our ignorance of the functions of DNA is profound. The disruptions to the complex mechanisms within the cell are therefore largely unknown and hence the interaction - and safety - of the ‘engineered organism’ with its environment is purely conjectured.

3. Even though molecules that break down DNA (Dnases) are extensively distributed throughout the environment, free DNA has been found in all ecosystems (marine, fresh water, sediments) studied. (23) Indeed, pooled data suggest that free DNA is present in significant amounts in our environment. Larger amounts of DNA are extracted from soil than can be extracted from the cells in the soil. (24) Further studies have shown that this free DNA in the soil comes from micro-organisms that no longer occur in that habitat (25) thus demonstrating that DNA can out-survive the organism it came from and still be capable of being taken up and expressed by micro-organisms.

4. Scientific data such as this should lead to serious concerns about the antibiotic resistance marker [ARM] genes that are present in virtually all GE plants presently on the market. These genes code for proteins that confer resistance to a given antibiotic. The possibility exists that these genes for antibiotic resistance could be taken up by bacteria, (in the gut, soil etc), thus exacerbating the already very serious problem of antibiotic resistance in disease causing organisms. The recent statement from Novartis, “ that they are anxious to get rid of ARM genes” is a tacit admission that the biotech industry may not be as safe as its proponents claim. [See Witness Brief Dr Conlon ]

5. It is also important to realise the detrimental impact that growing GE crops would have on our rapidly expanding organic markets. [See Witness Brief Dr John Clearwater. ] It is not true that the New Zealand fruit industry would be compromised by not adopting genetic engineering technology as clear evidence emerges of a world-wide demand for organic produce and a world-wide growing consumer rejection for all GE products. [See Witness Brief R. Anderson.]

6. Witness Briefs Attached

Name

Position

Presenting at Formal Hearing

Dr Peter Wills

Associate Professor Theoretical Biologist

University of Auckland

Dr Wills presented his Brief to

the Commission in December.

Dr John Clearwater

Researcher & Consultant for Organic Growing Systems

Yes

Dr Bernard Conlon

General Practitioner

Rural Practice in Murupara

Yes

Dr Neil Macgregor

Soil Scientist

Institute of Natural Resources

Massey University

Yes

Dr Michael Godfrey

Medical Director

Bay of Plenty Environmental

Health Clinic

Yes

Dr Ruth Lawson

Parasitologist

Lecturer

Otago Polytechnic

Robert Anderson

Retired Science Lecturer

Christie Hartlage

Environmental Ethicist

Yes

Section A (1)

A (1) The strategic options available to enable New Zealand to address, now and in the future, genetic modification, genetic modified organisms, and products.

New Zealand is currently in the position of having no genetically engineered organisms released into the environment. This is in marked contrast to a country like the United States where the genetic integrity of traditional crops can no longer be assured because of contamination from widely grown Genetically Engineered Organism (GEO) crops.

It is our position that New Zealand should maintain its GEO-free status into the foreseeable future. Our judgement is based on (a) an assessment of the uncertainties and uncontrollability of genetic engineering and its consequences and (b) the prospect for New Zealand to reintegrate agricultural production and other effects of human activity with natural ecological processes. (For example, organic farming and horticulture.)

We see the role of genetic engineering as providing a valuable set of laboratory and research techniques which are available for use in full containment for the purposes of fundamental research into aspects of molecular biology, subject to proper legislative and ethical controls.

We see the role of GE as providing a valuable set of laboratory and research techniques for fundamental research into the nature and function of the genome provided it is carried out in full containment and is subject to proper legislation and ethical controls.

The British Medical Association has called for an indefinite moratorium on the release of GE crops in Britain. The PSRG agrees with this and emphasises that the precautionary principle should dictate that in New Zealand we also declare an immediate moratorium on

(i) the release of any genetically engineered organisms into the environment, and

(ii) the incorporation of GEOs, their parts, processes and products, into the food chain.

A (1)

New Zealand must maintain her GE-free status. This is because there are so many unknowns about the technology and our considered opinion is that it is inherently dangerous. We consider that:

1. As biological containment cannot be guaranteed, calling for more comprehensive testing and monitoring procedures is imperative. Data accumulated over the last few years demonstrate that the concept of biological containment, on which existing legal regulation is based, cannot be guaranteed. The reasons are two-fold:

(a) Genetically engineered organisms can survive or transfer their transgenes to indigenous organisms, and their containment is not complete even if their biological containment is of a highly sophisticated manner. Risk assessment should not be satisfied with the assumption that a given GEO will not survive. It must extend to the fate of the DNA which may provide advantages for other micro-organisms ( 1)(2)(3)

(b) DNA persistence is stronger than imagined. Thus assessment for ecological and health impacts cannot stop with the assumption that a given GEO will not survive. Unexpected survival, dormancy, secondary transfers of genes through conjugation, transduction and transformation and DNA persistence need to be considered in designing procedures for contained use and even work with isolated recombinant DNA-sequences (the latter currently not subject to legal regulations and safety measures). Assessment should be extended to track the fate of GEOs/DNA which may be integrated and eventually expressed in indigenous organisms.

2. The principle of familiarity is inappropriate and a case-by-case approach is necessary. Each engineered organism is a separate case, so there can be no generic safety test.

Use of the principle of familiarity of function or resource-use by organisms in different ecosystems is thus problematical and inappropriate, especially when that function or resource-use by naturally-occurring organisms is not known. The state of “unknown” is more so for novel organisms. Given the present knowledge base that is too limited, the use of the principle of familiarity in environmental situations is dangerous.

3. A comprehensive case-by-case approach is necessary. Extrapolation from laboratory data to ecosystems cannot be accepted. With the demonstrated survival and persistence of genetically engineered organisms or DNA, (4)(5) even when they are “crippled”, there is concern now that the data from “contained use” may not be reliable. Existing field tests abroad have not been designed to collect environmental data, and test conditions do not proximate production conditions that include commercial scale, varying environments and time-scale. The argument that the safety of field trials predicts safety at the commercial scale is thus untrue.

4. We cannot claim that since plants in small confined and ecologically irrelevant field plots (used to study commercial features) have not ‘caused problems’ or have not ‘caused surprises’ then it will be safe to commercially release any transgenic forms. It is often claimed that there have been no adverse consequences from over 500 field releases in the US. However, the term ‘releases’ is completely misleading). Those tests were largely not scientific tests of realistic ecological concerns, yet “this sort of non-data on non-releases has been cited as though 500 true releases have now informed scientists that there are no legitimate scientific concerns”. (6)

5. Recently, for the first time, the data from the US Department of Agriculture field trials were evaluated to see whether they support the safety claims. The Union of Concerned Scientists (UCS), which conducted the evaluation, found that the data collected by the USDA on small-scale tests have little value for commercial risk assessment. Many reports fail to even mention - much less measure - environmental risks. Of those reports that allude to environmental risk, most have only visually scanned field plots looking for stray plants or isolated test crops from relatives (7).

6. In view of the above the UCS concluded that the observations that “nothing happened” in those hundreds of tests do not say much. In many cases, adverse impacts are subtle and would never be registered by scanning a field. In other cases, failure to observe evidence of the risk is due to the contained conditions of the tests. Many test crops are routinely isolated from wild relatives, a situation that guarantees no outcrossing. The UCS cautioned that “... care should be taken in citing the field test record as strong evidence for the safety of genetically engineered crops”.

7. The same concern was echoed by a commentary in Nature: “ ... it is a pity that opportunities to obtain appropriate data have been missed in the hundreds of completed field trials, which have emphasised agronomic performance and have been managed in a way which discouraged multi-generation observations on transgenic populations. The real question is what will happen when transgenic seeds are widely broadcast year after year in many different habitats, as would happen if genetically engineered crops are planted commercially.” (8) Even where testing in one ecosystem is adequate, it does not allow extrapolation of risk assessment to other dissimilar ecosystems.

Recent reorganisation and rationalisation of scientific research in New Zealand has meant that we have lost scientists conducting field work, now seen as ‘out of fashion’ as well as ecologists and their sophisticated understanding of ecological interactions.

The consequent general undervaluing of these disciplines further legitimise the limited view molecular biologists have of the natural world and allows them to insulate their work in a vacuum and continue to ignore the far reaching implications of what they are doing.

For this reason PSRG feels we should be increasing our field work which, at the present time is suffering against laboratory work, funding being poured into the more “fashionable” biotechnology. We should not underestimate the tremendous dividends our field scientists have brought to New Zealand both in agriculture and related ecological rewards.

8. The 1994 findings of Danish scientists on the spontaneous hybridisation between genetically engineered oilseed rape (for herbicide-tolerance) and a weedy natural relative provide strong evidence that transgenes could be dispersed to other plants, countering the assumption that genetically engineered crops will rarely, if ever, hybridise. It is such scientific work, particularly in recent years, that cautions us on the unpredictability of these crops, that should guide the decisions of the Commission and its ultimate recommendations to Government to impose a moratorium on all GEO releases.

9. As far as New Zealand is concerned an organic future would seem to be an eminently sensible conclusion/decision. In many countries, intensive organic systems are now proving to out-perform GE crops. These organic systems not only build up the quality of the soil and safeguard the ecology, they also build up local economies and provide wide safety margins for unpredictable weather conditions, together with protection of the rich biodiversity.

10. PSRG feels that genetic engineering should be used only for fundamental research into the nature of the genome and for medical purposes - not for the production of food crops or products.

11. We therefore call for an immediate moratorium in New Zealand on

(i) the release of any genetically engineered organisms into the environment, and

(ii) the incorporation of GEOs, their parts, processes and products, into the food chain.

Section A (2) Summary

We believe that the current legislative arrangements for the regulation of genetic engineering are inadequate. Under the current arrangements general concerns of the community have no legal force. Changes must be made to take these concerns into account.

The institutional arrangements in government and industry for the use of genetic engineering are also unsatisfactory. Large amounts of public money are invested in projects that do not have the support of the community. This must be addressed by government, funding agencies, universities and industry.

A (2)

1. The current legislation for the regulation of genetic engineering in New Zealand is unsuitable and should be amended to a more rigid criteria. To date virtually no attention has been given to the precautionary principle.

The great excitement this work engenders in scientists - not surprisingly - should not exempt them from applying this principle in all aspects of genetic engineering work. If this continues to be ignored the mistakes, when they inevitably arise, may well be too great and too late. (See A1 b above.)

Vast areas of GE monocultures - with all wildlife spray-dead and causing attendant problems of damaged soil and polluted water - are a poor scenario for food security. So far the United States, Holland, Germany, Australia and the UK, supported by giant biotech corporations, have consistently refused to sign legally binding safety protocols, calling instead for a “voluntary set of guidelines”.

2. PSRG also submits that changes are required to the HSNO Act as it applies to genetically engineered organisms (GEO’s) imported into or developed and held in laboratory-based containment. (See Witness Brief Dr P Wills.)

3. We also recommend a change in emphasis of funding of research in order that the expertise of our scientists is retained and research is maintained in both ecology generally and in sustainable agriculture in particular. The extravagant sums of money which have been allocated to this technology in the past has been seen to date to be generally wasted. As

Dr Mae-Wan Ho has said: “They have been making promises for the last 20 years, most of which have never materialised.” ($NZ140 million from the tax payers - so called “Good Science Fund”). Had similar funds been given to organic research and a sound farm advisory service the effect would undoubtedly be reaping considerable benefits. The biotech industry now faces a dilemma much of its won making. On one hand it has kept the consumer at bay while at the same time generating the necessary hype to ramp up financial support from its shareholders. As the New Scientist so eloquently put it, “Fuelled by hopes and dreams rather than actual products.” Many observers claim, the promises of the biotech companies are proving very hard to fulfil. Of the 430 biotech companies listed on the world’s stock exchanges only about 10% are profitable.(35) Surprising for such a “wonder technology.”?

* It may be relevant to note here that several of our members travelling around the country taking on this issue have compiled the same complaints from our farmers that, “They would be only to pleased to embark on organic methods but have no advisors to instruct them.” Why then are Federated Farmers - ostensibly there to represent NZ farming interests - so insistent on promoting GE?

Section B (a)

B (a) where how, and for what purposes GM, GMO’s and products are being used in New Zealand at present.

Section B (a) Summary

There is the widespread use of genetically engineered organisms in Universities, Crown Research Institutes, Industry and the Health Sector. All of these uses are currently restricted in that no genetically engineered organisms are released into the environment. Products of GEOs appear in food which is imported into New Zealand and are used in medicine, and there is the so far limited use of genetically engineered sheep for the production of a human protein.

B (a)

1. In the matter of medical GE research there are also risks and side effects, often trivialised by the establishment. Much further research is required in this field. The rush for profit from GE drugs is becoming both pervasive and dangerous. (See B[c][1] below and Witness Brief Dr B Conlon. and Dr M. Godfrey)

2. Humulin or GE ‘human insulin’, always claimed by proponents as a great GE success, has its share of controversy. While many diabetics can tolerate this medication a significant minority cannot. The UK Insulin Dependent Diabetic Trust was formed as a breakaway group from the British Diabetic Society to better represent those diabetic patients intolerant of GE human insulin. Strong criticism was levelled at the inadequate pre-marketing clinical trials. In 1980 the first study was published with 17 non-diabetic patients and by 1982 GE ‘human insulin’ was licensed. Within 8 years without any large-scale trials, 84% of UK diabetic patients were switched to GE human insulin. Between 1986 and1989 the British Diabetic Association received nearly 3,000 letters from families upset with problems associated with GE human insulin. In 1989 attention was drawn to the apparent increase in sudden unexplained deaths occurring in young insulin-dependent diabetics, going to bed in apparently good health and later being found dead in an undisturbed bed. The BDA professional Advisory Committee investigated the 50 deaths that happened in 1989 and were unable to give a satisfactory explanation for 22. (27) Poor hospital records meant that insulin batch nos. were not able to be correlated. All however had been switched to GE ‘human insulin’. There is currently a class-action suit against Eli Lilly and Novo Nordisk the manufacturers. [www.swissdiabetes.ch/~fis2/englvers/bellagio.html> also, “Consumer Involvement: A Dream or a Reality?” CERES newsletter, Winter 97/98, No 23.]

3. With the change in liability laws for pharmaceutical companies many questionable drugs, both GE and standard, are being insufficiently tested before being presented to the FDA for approval. Federal decisions on vaccines for instance, are made in secret by a small committee of non-accountable experts who have conflicts of interest, such as affiliation with manufacturers who stand to make enormous profits from required use of their product. The Association of American Physicians and Surgeons (AAPS) is calling for an immediate moratorium on mandatory hepatitis B vaccines for schoolchildren pending further research about dangerous side effects. (21)(22) [See also Dr Mike Godfrey on Hep B PSRG submission.]

4. The use of animals to produce pharmaceutical products is not considered to be a sensible use of this technology. The hyperbole and promises made by the various industries engaged in this work has so far been unproven. A recent example of this is the ERMA’s permission to splice human genes into sheep. The reasoning given by PPL was deceitful. There is no known scientific evidence that the AAT protein (alpha 1 antitrypsin) produced is likely to cure cystic fibrosis. Similarly, the claim that milk containing rhMBP, (obtained from a cow having the appropriate gene) if drunk by MS sufferers, decreases the illness, has no significant foundation. This does however, allow the research to proceed, allowing large dividends to be reaped from investment capital. AAT protein is regularly discarded from the blood fractions of blood donors. [See also B(e) para 7d.]

5. For reasons already given no GE food should be allowed into New Zealand. The ANZFA are working under a severe conflict of interest. They cannot serve to promote the interests of the food industry on the one hand and at the same time give unbiased consideration to the safety and health of consumers on the other.

We recommend a separate regulatory authority is established to deal with New Zealand foods. [See B(c)(i) para3.]

Section B (b) Summary

Genetic engineering has an extremely high degree of inherent uncertainty, especially when it comes to the overall consequences for the environment. This is because ecological and evolutionary processes are themselves uncontrollable. The consequences of genetic engineering are likely to be to a degree even more uncontrollable than the consequences of other human interference in biological processes.

B (b)

Uncertainty

1. We have only a very shallow knowledge of how the web of processes needed for life sustains itself. We are still largely ignorant of how changes traceable to events at the molecular level eventually manifest themselves in the large-scale features of complex ecological systems.

2. Seemingly minor genetic changes sometimes lead to the complete restructuring of biological systems, but molecular biology, with its emphasis on microscopic structures rather than global dynamics, does not enlighten us much as to the connection between the microscopic and macroscopic levels of organisation. The molecular genetic approach of most modern biology does not provide an adequate basis for evaluating the ecological effects of releasing genetically engineered organisms into the environment.

Likely consequences

3. The changes made by genetic engineers are likely to create very specific novel ecological interactions. Genetic engineering will create new, propagative phenomena as side-effects of its intended results. The eventual emergence and selection of as-yet-unknown plant parasites is an obvious possible consequence of incorporating plant viral genes into transgenic crops. The genes concerned will mutate from generation to generation in their novel molecular biological environments and create possibilities with which Nature has never before "experimented".

4. All regulation of genetic engineering, both national and international, is fundamentally permissive. Australia is one of the countries at the forefront of promoting the interests of big business biotechnology at the expense of the environment and human well-being. The only adverse effects given any weight in the consideration are those that can be demonstrated scientifically. A gamble is taken on insidious, low-level, generalised hazards and remotely unlikely catastrophes of enormous magnitude, all in the service of economic gain. For instance New Zealand’s almost negligible representation on ANZFA results in decisions - made chiefly by Australian States - having a flow on effect to us.

Ignorance of consequences

5. We have neither sufficient knowledge nor adequate understanding of biological processes at any level for us to make a reliable assessment of the disturbances that the products of genetic engineering will cause when they are released into the environment and enter the food chain.

Values

6. No assessment of risk, weighing cost against benefit, can be made without reference to a scale of value. Human society, now global, is attempting to determine ethical questions largely through technical scientific argument and discussion, as we are doing now with the question of genetic engineering in the food chain. The Western scientific tradition has become the common intellectual context for the technical discourse of risk analysis, internationally as well as locally. In the past we have relied on scientific knowledge which has proved itself in the rapid development of new technologies. However, we now have a very different situation. As Dr Mae-Wan Ho said, “There is a need to counteract the increasing commercialisation of science which not only threatens the integrity and independence of scientists, but raises more fundamental questions on the role of science in society and the nature of science itself. These questions are central to the very fabric of our lives, particularly in an age when science is working in such close association with industry.”

7. The essence of practical science is to restrict our view of the world to what can be analysed in purely material terms. The idea that everything that happens in the world can be understood in terms of the properties of matter and what happens to material bodies was first assimilated into biology in the theory of evolution. Now molecular biologists generally take this view of the world to be adequate for achieving a complete scientific understanding of everything there is to know about cells, organisms and ecosystems, from the origin of life three and a half billion years ago through to human consciousness. We do not believe this materialistic/scientific view of the world to be either adequate or realistic. We do not believe that one can explain the entire living world in terms of the mechanistic interaction between atoms and molecules.

8. An increasing variety of naked/free nucleic acids are now being made for use in research, industrial productions and medical applications, all of which are being released into the environment. They range from oligonucleotides to artificial constructs thousands and millions of base pairs in length, often containing heterogeneous arrays of genes from pathogenic bacteria, viruses and other genetic parasites belonging to every kingdom of living organisms. As most of them have never existed, or if they have, not in such large amounts, they are by definition, xenobiotics - substances foreign to nature - with the potential to cause harm (Dr Mae-Wan Ho, Report to the Biosafety Protocol Meeting, Montreal, January 2000).

Section B (c) Summary

The risks and benefits of using genetic engineering arise from a number of sources. We consider briefly that they arise from the uses in agriculture and food production, forestry, medicine, scientific research, environmental modification and military applications.

Agriculture: The potential risks and benefits include all those which are associated with large scale changes in global agriculture. These include issues of yield, crop stability, crop security, problems of mono-cultures, patterns of land use, demographic issues and farm economics. The main effect of the use of genetically engineered crops will be to place world food supplies in a fragile position of dependence on a poorly understood technology being used largely in the service of the economic interests of multi-nationals based in first world countries.

Food production: Genetic engineering of food poses unique risks to the human population. Whether we consider the consumption of genetically engineered organisms themselves (plant or animal) or products derived therefrom (processed foods, additives, extracts, proteins, etc.) there is the prospect of unidentified toxins and allergens entering the food chain and affecting large numbers of people, often undetected.

Forestry: Knowledge of the role of genetics in tree production is in its infancy and the uncertainties are too great for any realistic assessment of the effects of genetic engineering in forestry. Trees are particularly long lived organisms participating in complex interactions with both the physical and biological environment. Proposals involving the alteration of flowering and pollination patterns seem particularly foolhardy and hazardous.

Medicine: The benefits to be derived from applications of genetic engineering in medicine are enormous. This potential can only be realised if all the associated risks are adequately mitigated. Some of the benefits to be derived are (a) the production of new medicines, (b) the development of new therapies and (c) the investigation of disease processes. Some of the associated risks are (a) the creation of previously unknown diseases and disease vectors (bacterial pathogens, viruses, etc.), (b) side effects from experimental genetic therapies and (c) novel selective pressures producing new strains of existing pathogens.

Scientific research: Genetic engineering is a legitimate research tool which can be used for fundamental studies of the character of organisms and the manner in which they function at the molecular level. The main risk of using these techniques pertains to the possibility of setting in motion new and uncontrollable biological processes especially the replication of disruptive new organisms in the wild.

Environmental modification: The risks associated with the uncertainty and uncontrollability that attends all applications of genetic engineering far outweigh any benefits that are promised in this sphere.

Military applications: Such is the ambiguity between allowed defensive measures in biological warfare and prohibited offensive measures that all applications of genetic engineering for military purposes should be banned.

1. The major beneficiaries likely to prosper from the use and acceptance of GE crops and food are those industries selling it. Contrary to what they would like the public to believe, GE crops are neither needed nor beneficial. They have become a dangerous diversion from the real task of providing sustainable food for our world. At this stage the technologies of genetic engineering are still crude, unreliable, uncontrollable and unpredictable - in short they do not qualify as technologies. (See Witness Brief Robert Anderson.)

2. It is clear that there is disagreement within the scientific community regarding the safety of Genetic Engineering. Until further independent research clarifies this situation it is the opinion of the PSRG that no open releases of transgenic organisms should occur in New Zealand. All genetic engineering experimentation should be restricted to closed laboratory situations. This will allow continued research whilst providing a level of protection that the New Zealand environment deserves. We acknowledge our pragmatism with accepting medical GE products e.g. GE insulin and GE erythropoeitin; however these are for individuals with existing medical problems with consequently unique risk/benefit consideration.

Furthermore, these products are from a closed system with filtration and purification providing an essential filter for unwanted (and unplanned) toxins and allergens.

3. Vast sums of money have been invested in GE technology and the power of multinational business is in obvious motion. Grants determine the direction of research with often simplistic one-dimensional goals targeted which are ill-thought through for their possible multi-dimensional impacts. Meanwhile, more natural, safer options are not considered. The development of vitamin A enhanced “golden rice” is a typical example. ‘Golden rice’ was developed in two European laboratories and funded by the Rockefeller Foundation with little or no reference to the reality of vitamin A deficiency blindness in communities in Africa and South East Asia. Vitamin A deficiency rarely occurs in isolation, but is one of a complex range of vitamin and mineral deficiencies occurring within the context of poverty, environmental degradation, and social disparity. It was only when it was a reality in the laboratory that the research teams contacted international institutions like UNICEF, the FAO and the WHO and were informed that the use of a single nutrient to combat multi-micronutrient malnutrition simply does not make sense when there are plenty of alternative and infinitely cheaper sources of vitamin A or pro-vitamin A available - such as green vegetables and unpolished rice - which would also be rich in other essential vitamins and minerals. Nevertheless, research continues and ‘golden rice’ is promoted aggressively mainly because it provides an opportunity to allay concerns about corporate control of biotechnology and restore its public acceptance in the face of growing resistance to the first generation of genetically engineered foodstuffs. [See appendix 1 to 2.]

4. We are very concerned with the controversy over the safety of vectors and believe more research is required to clarify infectivity and pathogenicity. [See appendix 3 to 7.]

Can such rampant unregulated gene shuffling be safe? Recent research indicates that GE genetic material can persist for over two years and that horizontal gene transfer allows uptake to both plants and animals. [See appendix 8.] Recombination within the genome does happen and this represents the major cause for concern over the inadvertent creation of new pathogens. [See appendix 9.] Infectious diseases are also clearly on the increase, showing increasing virulence and antibiotic resistance. (30) [See appendix 10.]

5. The possible creation of new pathogens represents the greatest threat to public health and the repercussions of genetic engineering in this field are clearly not recognised It is therefore unwise and irresponsible to allow any open releases of transgenic organisms into our environment with our present state of ignorance. The last paragraph of Dr Erwin Chargoff’s letter, The Dangers of Genetic Meddling, written to the Journal of Science 192: 938-940, is apt and poignant.

“Bacteria and Viruses have always formed a most effective biological underground. The Guerrilla warfare through which they act on higher forms of life is only imperfectly understood. By adding to this arsenal freakish forms of life - prokaryotes propagating eukaryotic genes - we shall be throwing a veil of uncertainties over the life of coming generations. Have we the right to counteract, irreversibly, the evolutionary wisdom of millions of years, in order to satisfy the ambition and curiosity of a few scientists? This world is given to us on loan. We come and we go; and after a time we leave earth and air and water to others who come after us. My generation, or perhaps the one preceding mine, has been the first to engage, under the leadership of exact sciences, in a destructive colonial warfare against nature. The future will curse us for it.”

The risks to the environment from genetic engineering are formidable and in virtually all cases irreversible.

B (c) (i)

No matter which field of endeavour to which genetic engineering can be applied we consider the benefits accrue to the powerful economic players - agricultural and pharmaceutical corporations, governmental agencies and research institutions. The benefits to individuals that various proponents of genetic engineering claim depend very much on the perspective from which we view what is being achieved. Only in the field of medicine can it really be argued that individuals will reap any significant benefit.

1. The only group who are likely to benefit from the use and acceptance of GE crops and food are industries selling it. Contrary to what they would like the public to believe, GE crops are neither needed nor beneficial. They have become a dangerous diversion from the real task of providing sustainable food for our world. At this stage the technologies of genetic engineering are still crude, unreliable, uncontrollable and unpredictable - in short they do not qualify as technologies. Because New Zealand has a rapidly growing organic market, due to the tidal wave of consumer resistance to GE foods, it would be irrational/irresponsible to jeopardise this at such an early stage by introducing GE crops. (See Witness Brief Dr John Clearwater.)

2. Consumers of GE foods and products are unlikely to benefit as no commercially available food product to date has been engineered to provide benefits to the consumer. Rather, because of the innate uncertainties of the technology and the acknowledged hazards of the products, ordinary people may be exposed to unknown risks. Such a statement - made by scientist Dr Linda Smith of ACRE, and others - that, “safety is not an issue,” (9) is a deeply worrying and questionable assumption. Science and technology, as much as scientists, should be both socially and ecologically accountable.

Despite official statements to the contrary by the Food and Drug Administration, the predominant but suppressed opinion of their own scientists as expressed in their administrative record is that GE foods are different from conventional foods, that they pose unique health risks and that each one should be established as safe through rigorous testing.

[ www.biointegrity.org]

3. Up to 100 000 people die every year in the US alone from the side effects of modern drugs which are - generally - tested to a far higher standard than genetically engineered foods. We can, therefore, only imagine the risks imposed on us by ‘engineering’ food. Contrary to ANZFA’s statements, GE foods have never had long term testing for their toxicological or carcinogenic risks or other risks. The statement in the NZ Grocery leaflet put out to consumers, “GM Foods, Answers to your questions”, exemplifies the misinformation propagated to push GE products onto the market. Their statement that, “GM Foods are among the most extensively tested foods ever sold in the history of mankind”, is manifestly absurd and refuted. The constant claim of the British Government “Beef is safe” in the wake of the BSE crisis demonstrates clearly Governments reluctance to heed warnings of their unindentured scientists and doctors who express these fears. Again PSRG warns that GE foods are not safe. [See, “Inquiry Blames Missed Warnings for Scale of Britain’s BSE Crisis” and also Dr Ruth Lawson’s Witness Brief. ]

4. The producers are unlikely to benefit. Few if any GE crop to date has performed as designed or promoted; for example Bt. corn, RR soy, FlavrSavr tomato. [See R.Anderson’s Witness Brief.]

5. It is also extremely unlikely that the poor and starving populations of the Third World countries will benefit from this technology. If anything it will cause further suffering because biotechnology addresses few of the underlying problems of Third World hunger. People do not go hungry because of an overall world shortage of food. The latest assessment of world population trends by the UN (Report by the Global Perspective Studies Unit, Food and Agriculture Organisation (FAO) (1999) indicates that the rate at which the world’s population is growing has slowed considerably, and that there is enough, or more than enough, food production potential to meet the growth of future demand for the world as a whole. The problem is that many people are too poor to buy readily available food because they are deprived of land by a powerful few, trapped in debt, or are miserably paid. The widespread adoption of biotechnology would strengthen the control of private global corporations over food supplies and food production technologies and exacerbate rural inequalities. GE crops are unlikely to produce higher yields or net returns than conventional varieties and the seeds will inevitably cost more . People (as opposed to many governments, scientists and biotechnology companies) in Third World countries targeted for this technology are quite clear they do not want it. They see it as unsafe for both health and the environment and likely to increase the already crippling debt repayments they are forced to pay to the First World.

6. The concept of “terminator” seeds is sufficient to show the true philosophy of these companies and to summarily dismiss their professed motive of “helping the starving millions”.

7. It is likely that the only consumer group to benefit is those using medicines produced by GE. Future GE pharmaceuticals may have greater purity, may be more effective and might possibly be cheaper than pharmaceuticals produced by conventional means. However, as long as the industry is dominated by vested interests, consumer welfare and safety will continue to come second to the imperative to maximise profit. [See Dr M Godfrey’s Witness Brief.]

B (c) (ii)

The risks arising from genetic engineering are almost completely socialised. It is the community as a whole which ends up bearing the cost of adverse effects that can arise from genetic engineering. The persons who create the risks are invariably absolved from any liability for the consequences of their actions.

1. We refute the statement of the University of Canterbury Submission (and several others) on this issue that; “If containment facilities are adequate, the risks to the environment and health of low-risk GE are negligible”. Containment requirements for many of the so called “low risk” experiments have been grossly inadequate in the past. The field trial of insect- pollinated Brassica napus, supposedly supervised by the ERMA, was found to be covered with ‘bird’ netting, which also had several holes in. The “containment” of the King Salmon company’s facilities, exposed by MP Jeanette Fitzsimons, was similarly grossly inadequate.

2. Furthermore the statement that, “To our knowledge, no ecological hazard has ever been reported to emerge from experiments conducted in containment anywhere in the world”, is a rather glib statement in light of the fact that Klebsiella planticola had been tested in containment and found to be successful. Due for commercial release, it was only when

Dr Elaine Ingham had the foresight to test it in non-sterile soils that the formidable danger revealed itself - that in all soil types tested the planticola killed off the nutrient bacteria in the soil (Holmes and Ingham, 1995). To quote Dr Ingham, “Had this been released commercially we would have had a world without plants.” (See Witness Brief Robert Anderson.)

For reasons such as these PSRG ask the Commission to recommend that there be no release of genetically engineered organisms into the New Zealand environment.

3. Farmers and horticulturists growing organic or guaranteed non-GE crops will be disadvantaged by the introduction of GE crops to New Zealand. The potential for indiscriminate and uncontrollable spread of pollen and seed means that once any GE crop is introduced here, not only will it be impossible to guarantee that conventional and organic crops are free of GE contamination, but also world confidence that New Zealand can supply ANY GE-free products will be jeopardized or lost completely.

Section B (d)

B (d) the international legal obligations of New Zealand in relation to genetic modification, genetically modified organisms, and products.

Section B (d) Summary

Successive New Zealand governments have become parties to a number of agreements affecting citizens who have had no say in the matter. In respect of the safety of our food supply, we are now subject to decisions that are made by an international body (ANZFA) which is dominated by industrial interests. In respect to maintaining our current GE-free status, we could be under threat of challenges to the WTO. All considerations in relation to these international obligations are dominated completely by scientific and technical matters and the unique cultural and ethical perspective of New Zealanders is given absolutely no weight.

B (d)

1. Because of increasing concerns over the hazards posed by GE to health and to the environment, and in particular the adverse effects on the conservation and sustainable use of biological diversity, PRSG - together with many world scientists - calls for the adoption of a legally binding international protocol on biosafety.

2. In recognition of the threats to biological diversity and human health, as research and commercial application of gene biotechnology grows, governments from more than 150 countries agreed that the need for and modalities of such a protocol would be considered under the Convention on Biological Diversity. Soon after the Convention was opened for signing the United Nations Environmental Programme (UNEP) established four expert panels to assist Contracting Parties in identifying priority areas for the implementation of the Convention. The UNEP Experts Panel considered a biosafety protocol to be a matter of critical importance. PSRG ask that the Commission recommends that New Zealand became a party to this vital measure.

3. The experience in the trans-boundary movement of hazardous wastes underscores the vital importance of a legally binding international biosafety protocol. It was precisely in the absence of international regulation that millions of tonnes of toxic wastes were exported, often illegally, to developing countries, resulting in severe environmental and human health problems for the host countries.

The precautionary approach, prior informed consent and a rejection by the international community of unscrupulous actions by transnational corporations that transfer hazards to countries which are unsuspecting or unable to deal with the toxic wastes, are aspects that find their parallel in the use and release of genetically engineered organisms. See survival of GMO’s in tropical aquatic environments (10)

From March 1988 onwards Britain off loaded tens of thousands of tonnes of potentially infected cattle feed on the Third World after deciding it was too dangerous to give to its own herds because it had been linked to the outbreak of bovine spongiform encephalopathy (BSE) in British herds. (The New Zealand Herald, Section B, 30 October 2000.)

Numerous recent media reports detailed how genetically engineered crops which had failed to find markets in the First World were off-loaded on the Third World in areas experiencing drought or other food shortages.

The biotech industry’s vehement opposition to any form of Biosafety Protocol cannot be heeded when considering the health and safety of nations and people.

Section B (e)

B (e) The liability issues involved, or likely to be involved, now or in the future, in relation to the use in New Zealand, of GM, GMO’s and products.

Section B (e) Summary

Liability issues arise in respect of all of the risks associated with genetic engineering. In no case has the public been given any protection beyond the legal requirement of due diligence being exercised by regulatory authorities. No insurance companies will provide indemnity against the eventuality of harm arising from a genetically engineered organism. This is because the potential hazards cannot be assessed let alone quantified.

Section B (e)

1. The most important peril from GEOs is that the genes can multiply, mutate, recombine and spread out of control. Experiences with pest organisms, including chestnut blight, Mediterranean fruit-flies, opossums in New Zealand, and even with bio-control organisms released to control these pests, are unmistakable lessons that once loose, released organisms cannot be recalled. Genetic engineering and its commercial application, have ecological, safety, health and socio-economic implications which are not yet adequately assessed, monitored or regulated. There is also growing evidence that public concerns over these implications are scientifically-founded.

2. The very fact that virtually all insurance companies are reluctant to cover biotechnology enterprises and their products is surely a tacit agreement that the risks from this industry are too great. Recent scientific findings affirm the serious inadequacies in existing regulations and testing procedures, as well as the degree of unpredictability with regards to the ecological impacts of transgenic organisms. (See section B[c][ii] 2.) Recent scientific findings affirm the serious inadequacies in existing regulations and testing procedures, as well as the degree of unpredictability with regards to the ecological impacts of transgenic organisms.

3. PSRG maintain that some of the benefits of research projects being undertaken in New Zealand are hypothetical, and consequently insubstantial. The incremental scientific knowledge which may emerge is of insufficient benefit to deal with the gravity of the risks involved should something go wrong. This risk of environmental damage will not be born by companies (for instance, those such as PPL ), but the tax payer. The continued use of our facilities given over to carry out GE research for foreign purchasers should be severely scrutinised. Many of these projects would not be allowed on the purchasers’ own soil.

4. A recent example of this is the ERMA’s permission to splice human genes into sheep. The reasoning given by PPL was deceitful. There is no known scientific evidence that the AAT protein produced is likely to cure cystic fibrosis. Similarly, the claim that milk containing rhMBP, if drunk by MS sufferers, decreases the illness, has no significant foundation. (AAT protein is regularly discarded from the blood fractions of blood donors.) [See Dr Peter Wills and Dr Robert Mann’s submission to ERMA.]

5. We believe the ERMA is inadequate to police this industry. Our world is at the beginning of an exciting era for molecular biology. While we are in full support of further research we feel that this whole field is sufficiently formidable to be carried out only in stringently controlled facilities. We do not agree with Dr Richard Newcomb (HortResearch) that, “The obligation to prepare and maintain a public register of GEO’s results in a number of serious intellectual property problems” and that this should prevent us doing so. The policing of the HSNO Act is very lax and we cannot afford to make mistakes with a technology having greater dangers even than those of nuclear pollution.

6. We agree with several of Professor Alison Stewart (Lincoln University Brief) suggestions. Her simple specific, but obvious cautions such as (Appendix D Excerpt from AS/NZS 2243.3 Section 3.5 3.5.2 [g]), “Where the laboratory is provided with opening windows, flyscreens shall be fitted” is a fairly obvious one. Also important is her suggestion that, “The current containment regulations do not differentiate between classes of organisms e.g. mammals, plants, viruses, bacteria and fungi. As the aforementioned organisms have diverse methods of reproduction and dispersal, specific protocols need to be made for these in PC2 regulations.”

7. The ERMA has proved itself unable to regulate this formidable industry, by the wealth of applications accepted to date one cannot but infer they encourage this dangerous technology into New Zealand at any cost. Here are some of the transgressions:

a. Of the 152 unauthorised experiments recently discovered, the various bodies were left to regulate themselves. (NZPA) (They received “a slap over the wrist with a wet towel”; Green Party Media Release.)

b. GE salmon - with risks of escaping eggs and waste material into the Marlborough Sounds.

c. The field trial of insect-pollinated rape covered with insect-pregnable bird netting.

d. Regarding the human gene in sheep to produce AAT protein in the milk., the ERMA were warned by several scientists of dangers including that of the protein becoming a prion. (See Dr P Wills’ Submission to ERMA.) These warnings were ignored and, like virtually all other submissions, allowed to continue.

8. This reckless disregard for both safety of the environment and public we considered culpable in the light of world-wide information coming in from scientific findings on biotechnology issues. GEOs which are currently intended for commercial release are designed to be robust and vigorous. They may migrate, mutate and multiply. This self-replicating nature of genetic material and lateral spread through ecosystems results in an unpredictable situation. For instance, Pukall (12) isolated plasmids with mobilising capability from soil probes and pig manure in numbers substantially higher than estimated.

Such plasmids can transform competent cells living in soil or manure environments also under suboptimal conditions and may be able to mobilise recombinant plasmids in these cells. (13)

9. In contrast, laboratory strains of GEOs are supposedly not designed to survive in an open environment. It is therefore often assumed that the environment is protected from the spread of genetically engineered organisms used in contained conditions (laboratories). However, increasing evidence has emerged demonstrating the viability of engineered organisms thought to be unable to survive outside laboratory conditions. These organisms have been found to survive in waste water and sludge, (11 ) soils and aquatic ecosystems (river, lake, and especially particles at the bottom of lakes). Ostensibly “crippled” micro-organisms have evidently managed to survive and compete with indigenous micro-organisms.

10. Potential hazards exist even where genetically engineered organisms survive only for a short period in natural environments, because some of them are capable of transferring part of their nucleic acids to other members of a given ecosystem by means of conjugation even if they do not possess self-transmissible plasmids. (15) The rapid spread of antibiotic resistance markers has now been documented. In 1982, streptothricin was administered to pigs in eastern Germany. By 1983, plasmids encoding steptothricin resistance were found in the pig gut bacteria. (See Witness Brief Dr B Conlon.) This had spread to the gut bacteria of farm workers and their family members by 1984, and to the general public and pathological strains of bacteria the following year. The antibiotic was withdrawn in 1990. Yet the prevalence of the resistance plasmid has remained high when monitored in 1993 (14) (Also see Dr Ruth Lawson’s Brief.)

Section B (f)

B (f) the intellectual property issues involved, or likely to be involved, now or in the future, in relation to the use in New Zealand of genetic modification, GMO’s and products.

Section B (f) Summary

Intellectual property law has been developed using a set of concepts and precedents which cannot be applied to living organisms or genes. This has lead to an untenable situation where those who conduct research involving genetic engineering are able to take control of natural resources that have resided in the commons for billions of years.

B (f)

1. The effect of US patent laws have been devastating. The identification of human genetic traits, their patenting and preservation in secret, has reached a terrifying level. PSRG are hopeful that the Commission will call for an immediate suspension to these patents on life-forms and living processes, because they are deeply immoral. Patents on living processes are nothing more than thefts from nature. They expropriate the knowledge accumulated by indigenous peoples - Maori in the case of New Zealand - and by previous generations of scientists who have worked entirely for the public good. The patents threaten food security and they violate basic human rights and dignity. They also compromise healthcare, impede medical and scientific research and are against animal welfare. PSRG ask the Commission to recommend that the New Zealand Government became a signatory to the “Genetic Bill of Rights”.

2. Since it is relatively cheap to analyse and patent a gene sequence it cannot be argued that patents are needed to regain substantial investment for discovering and isolating a gene. Many companies try to patent gene sequences on a routine basis, even though they know they do not have the capacity to develop anything. By owning a patent on the gene, the owner can control all possible future applications of the gene, no matter who actually does the work to develop a new drug.

3. New Zealand should not be a party to this kind of ‘theft’. Such corporations want monopolies on gene sequences only in order to control the research and development of new drugs and their markets. Granting patents on genes is totally unjustified or unjustifiable.(16 ) The biotechnology industry is already dominated by multinationals with interests in pharmaceuticals and agro-chemicals. If we agree to support this patent system, to include the whole range of living material, it will enable Corporations to consolidate their primacy in the marketplace. What industry wants is intellectual ownership of the basic raw material - the gene sequences. If you own the genes, you own the technology and all its uses. This is deregulation and globalisation at its worst.

Section B (g)

B (g) the Crown’s responsibilities under the Treaty of Waitangi in relation to genetic modification, genetically modified organisms, and products.

Section B (g) Summary

It is PSRG’s view that the Crown has a duty to do much more than simply consult with Maori on these issues in the manner we have observed to date. In particular we wish to see force given to Maori concerns of Mauri, Wairua and Whakapapa as a duty of partnership under the Treaty.

Section B (h)

B (h) the global developments and issues that may influence the manner in which New Zealand may use, or limit the use, of GM, GMO’s and products.

Section B (h) Summary

In the medium term (the next century) humanity will have to face increasing pressure from its dominance over the biosphere. Questions of human population, food production, land use, resource management, water and energy will have to be addressed from a perspective that considers the sustainability and integrity of the entire biosphere as well as issues of global social and economic justice. Genetic engineering does not provide an appropriate basis on which to build acceptable solutions to these looming problems.

There seems to be a gathering consensus that the first generation of genetically engineered foods are going to have to be abandoned and vague promises of the characteristics of a second generation of genetically engineered foods are now being offered.

B (h)

1. The world markets for GE crops and food is presenting a growing tidal wave of resistance, which has now reached even the shores of the USA. The collapse of this market has sired an enormous growth in the world market for organic foods. New Zealand is ideally placed to reap such a benefit

2. There has been a world-wide explosion in the demand for organic sustainable crops and our market for them is growing at an enormous rate. PSRG see no reason why New Zealand could not became one of the world’s foremost organic suppliers. Our isolated island status gives us a unique advantage over the rest of the world to be GE-free and maintain sustainable, organic methods of food crop production, to the advantage of our export industry.

3. We agree with Dr.Max Suckling (HortResearch Witness Brief) that, “there seems to be little prospect of compatibility between organics and GM.” The idea, vigorously put forward by Biotech Companies, that organic and GE can co-exist, is total nonsense. Once GE crops are introduced into the New Zealand environment, the organic growers, together with our honey industry, will - on the evidence to date - be irrevocably destroyed.

4. As far as New Zealand is concerned an organic future would seem to be an eminently sensible conclusion. The reasoning put forward by Dr Susan Gardiner (HortResearch Witness Brief), advocating GE in an effort to reduce spray, is seriously flawed. There is no evidence to date that GE has significantly reduced the use of pesticides (see Dr Ruth Lawson’s Witness Brief). We refer to the instance given that, “In the USA application of chemical sprays accounts for almost 13% of the cost of production of apples.” PSRG member, Dr John Clearwater, has to date avoided most of these pitfalls and is getting premium prices for organic apples grown in NZ. (See Witness Brief Dr .J Clearwater.)

5. Furthermore, Dr Gardiner’s comparison with the work of Luther Burbank on hybridisation is hardly a fair one. It is most unlikely that toxins or similar would originate from such a natural breeding process, whereas many are showing up from GE. (See Section Toxins and Unexpected Effects.)

6. Recent reports from the USA, Kenya, China and other regions, show intensive organic systems are proving to out-perform GE crops and reduce the damage caused by pests. The following are just some

Organic highlights

* some 223,000 farmers in southern Brazil using green manure and cover crops of legumes and livestock integration have doubled yields of maize and wheat to 4-5 tons/ha;

* some 45,000 farmers in Guatemala and Honduras have used regenerative technologies to triple maize yields to some 2-2.5 tons/ha and diversify their upland farms, which has led to local economic growth that has in turn encouraged re-migration back from the cities;

* more than 300,000 farmers in southern and western India farming in dry land conditions, and now using a range of water and soil management technologies, have tripled sorghum and millet yields to some 2-2.5 tons/hectare;

* some 200,000 farmers across Kenya, as part of various government and non-government soil and water conservation and sustainable agriculture programmes, have more than doubled their maize yields to about 2.5 to 3.3 t/ha and substantially improved vegetable production through the dry seasons;

* 100,000 small coffee farmers in Mexico have adopted fully organic production methods and increased yields by half;

* a million wetland rice farmers in Bangladesh, China, India, Indonesia, Malaysia, Philippines, Sri Lanka, Thailand and Vietnam have shifted to sustainable agriculture, where group-based farmer-field schools have enabled farmers to learn alternatives to pesticides whilst still increasing their yields by about 10%;

* after summer drought, The Rodale Institute’s yield (US) from its 330 acre organic research farm was 24-30 bushels soybeans/acre, while yields on neighbouring plots, doused in synthetic fertilizers and farm chemicals, were 16 bushels/acre.

Section B (i)

B (i) the opportunities that may be open to New Zealand from the use or avoidance of GM, GMO’s, and products.

Section B (i) Summary

It is the view of PSRG that research and limited, contained use in medicine are the only currently legitimate uses for genetic engineering.

Contamination of organic products with genetically engineered material is now widespread in the USA with consequent suspicion and concern from the public. We seek to avoid a similar situation in New Zealand by preventing any field release of genetically engineered plants.

The demonstration of successful production of organic apples sends an unmistakable sign to all New Zealand’s growing industries that substantial profit is available to each of them given sufficient effort in developing appropriate growing methods.

B (i)

1. New Zealand has a wonderful and unique biodiversity. If it is to be protected for future generations the release of GEO’s and plants must be stopped at all costs. Our “Clean Green Image” is the most precious trademark that we possess. Introduction of GEOs into New Zealand will destroy this image especially in the eyes of Japanese and European tourists and markets.

2. It is now known that widespread dispersal of pollen and seeds occurs and contamination during transport and storage means that even with the best of intentions it is almost impossible to prevent contamination of non-GE and organic crops with GE genes. In the UK and Canada herbicide resistance has spread to other plants. In Germany long-term persistence of transgenic DNA has been shown under field conditions (up to 2 years) and also in soil microcosms with introduced transgenic plant DNA. (29) Thousands of acres in Britain have been contaminated by pollen blown from large fields of genetically modified oilseed rape which they have discovered remains fertile over greater distances than expected. Canada has also suffered considerable pollution of various kinds from GE crops. Moreover, the Canadian honey industry has suffered severe setbacks from Europe refusing honey contaminated by GE pollen. Our bee keepers here are very concerned that they do not suffer the same fate.

Contamination of organic products with genetically engineered material is now widespread in the USA with consequent suspicion and concern from the public. This should be sufficient warning to New Zealand to exercise the greatest care. To allow this to be sullied by the spectre of GE would cost New Zealand very dearly in the market place. We have a unique opportunity to retain and build on our lucrative tourist, agricultural and horticultural markets by taking this opportunity to avoid the introduction of GEOs and plants into New Zealand..

3. We believe that many of the benefits of research projects being undertaken in New Zealand are hypothetical, and consequently insubstantial. The incremental scientific knowledge which may emerge is of insufficient benefit to deal with the gravity of the risks involved should something go wrong. This risk of environmental damage will not be born by companies (such as PPL ) but the tax payer.

4. The continued use of our facilities, given over to carry out GE research for foreign purchasers should be severely scrutinised. Many of these projects would not be allowed on their own soil.

Section B (j)

B (j) the main areas of public interest in GM, GMO’s and products, including those related to;

(i) human health (including biomedical, food safety, and consumer choice)

(ii) environmental matters (including biodiversity, biosecurity, and the health of ecosystems.

(iii) economic matters(including research and innovation, business development, primary

Section B (j) Summary

B (j) (i)

The application of genetic engineering to human health issues can be considered from both an individual and community perspective. Provided it can be guaranteed that there are not general side effects from use of GE by individuals seeking cures to medical problems of genetic origin, PSRG supports the use of genetic engineering in contained medical research and production.

We consider that GE has the potential to produce unexpected and potentially dangerous changes in foodstuffs which, in the absence of any long-term independent safety assessment, could remain undetected. We therefore oppose the use of GE ingredients in foods until such testing has been completed.

The introduction of GE ingredients into the food of almost every New Zealander without their knowledge and certainly without their consent is reprehensible. At the very least full and comprehensive labelling must enable consumer to make a choice about whether or not

consumers eat GE ingredients.

1. Biomedical applications of GE are the only area where the technology may be beneficial.

We reiterate the need for confinement, stringent regulation and safety testing.

Humulin or GE ‘human insulin’, always claimed by proponents as a great GE success, has its share of controversy. While many diabetics can tolerate this medication a significant minority cannot. The UK Insulin Dependent Diabetic Trust was formed as a breakaway group from the British Diabetic Society to better represent those diabetic patients intolerant of GE human insulin. Strong criticism was levelled at the inadequate pre- marketing clinical trials . In 1980 the first study was published with 17 non-diabetic patients and by 1982 GE .human insulin. was licensed.

Within 8 years without any large-scale trials, 84% of UK diabetic patients were switched to GE human insulin . Between 1986 and1989 the British Diabetic Association received nearly 3,000 letters from families upset with problems associated with GE human insulin. In 1989 attention was drawn to the apparent increase in sudden unexplained deaths occurring in young insulin-dependent diabetics, going to bed in apparently good health and later being found dead in an undisturbed bed. The BDA professional Advisory Committee investigated the 50 deaths that happened in 1989 and were unable to give a satisfactory explanation for 22. (27) Poor hospital records meant that insulin batch nos. were not able to be correlated. All however had been switched to GE ‘human insulin’. At present there is currently a class-action suit against Eli Lilly and Novo Nordisk the manufacturers. [<www.swissdiabetes.ch/~fis2/englvers/bellagio.html>].

2. We consider that GE has the potential to produce unexpected and potentially dangerous changes in foodstuffs which, in the absence of any long-term independent safety assessment, could remain undetected. We therefore oppose the use of GE ingredients in foods until such testing has been completed.

3. The public is quite clear they do not want genetically engineered food. Ignoring this fact, the Government have allowed the ANZFA, now reluctantly labelling, to bring this food into New Zealand.

3. We do not agree with the statement from several submitters that, “The public interest is threatened if NZ cannot maintain an independent expertise in the genetic sciences.” The public have made it patently clear - at least 92 000 signatures on one petition alone - that they do not want genetic engineering. Rather than rushing onto this potentially dangerous bandwagon that appears to benefit no one except the scientific community and the biotechnology industry, we should make sure we retain and expand our expertise in other scientific areas such as ecology and sustainable agriculture.

B (j) (ii)

The consequences of genetic engineering are so uncertain and uncontrollable, particularly in regard to ecological and evolutionary processes, that the protection of the environment demands that humans do not deposit the products of their experimentation in the wild.

1. We are concerned that pro-GE scientists do not more freely admit the major gaps in our knowledge of the genome. [See Appendix 11, 12 and 13.] The mechanics and risks of recombinant DNA technology are substantially different from those of natural methods of breeding. The latter are typically based on sexual reproduction between organisms of the same or closely related species. Normally, entire sets of genes are paired in an orderly manner that maintains a fixed sequence of genetic information. Every gene remains under the control of the organism’s intricately balanced regulatory system.

The substances produced by the genes are those that have been within the species for a long stretch of biological time. In contrast, biotechnicians take cells that are the result of normal reproduction and randomly splice a chunk of foreign genetic material into their genome. This always disturbs the function of the region of native DNA into which the material wedges. Further, the foreign genes will usually not express within their new environment without a big artificial boost, which is supplied by fusing them to promoters from viruses or pathogenic bacteria. As a result, these genes operate essentially as independent agents outside the host organism’s regulatory system, which can lead to many deleterious imbalances.

2. Moreover, this unregulated activity produces substances that have never been in the host species before and are usually very different from any that have. This is the reason for our concern over the production of unpredicted toxins or allergens or the degradation of nutritional value. Consequently, whereas we can generally predict that food produced through conventional breeding will be safe, we cannot make a similar prediction in the case of any genetically engineered food. Therefore, the only way even to begin to assure ourselves about the safety of a genetically engineered food-yielding organisms is through carefully designed long-term feeding studies employing the whole food; and it would be necessary to test each distinct insertion of genetic material, regardless of whether the same set of genetic material in the same type of organism has previously been tested. In contrast, food safety tests have been superficial and flawed. [See Appendix 14] and regulation for GE food revolves around the bureaucratic concept of “substantial equivalence”. Public health is not well served by this stance.

3. Excepts from the British Medical Association Interim Statement on the Impact of Genetic Modification on Agriculture, Food and Health, May 1999 supports the viewpoint:

(a) The principle of “substantial equivalence” is used for assessing GM food safety. It involves comparing a new product to one already accepted as safe. This concept does not account for gene interaction of unexpected kinds which may take place in GM foods. The possibility that certain novel genes inserted into food may cause problems to humans Is a real possibility, and “substantial equivalence” is a rule which can be used to evade this biological fact.

(b) On the basis of the Precautionary Principle, we question the assumption of “substantial equivalence”, and ask what risk assessment has been carried out to consider the health effects of GM foods.

(c) The BMA believes that more research on issues around allergenicity and possible toxicity of GM foodstuffs needs to be undertaken.

(d) The BMA believes that the use of antibiotic resistant market genes in GM foodstuffs is a completely unacceptable risk, however slight, to human health. [See Appendix 15.]

4. An excerpt from the personal testimony of Philip J Regal, Professor of Ecology, Behaviour and Evolution at the University of Minnesota, given on 28 May 1999 for the legal proceedings against the FDA, is pertinent: “I am not aware of any reliable study published in the peer-reviewed scientific literature which demonstrates that these risks are categorically either (1) negligible or (2) no greater than in the case of conventionally produced organisms. Nor am I aware of even one such peer-reviewed, professionally published study which has detailed scientific criteria for testing and evaluation and gone on to demonstrate that even one particular genetically engineered food is reasonably certain to product no harm when eaten by a human being.” [See Appendix 16.]

5. The FDA’s own records reveal it declared GE foods to be safe in the face of broad disagreement from its own experts - all the while claiming an overwhelming scientific consensus supported its stance.

The FDA documents are available at <www.biointegrity.org/list.html>. [See Appendices 17 and 18.] Unfortunately there is more evidence that protection of public health has been subordinated to commercial interests in the USA. [See Appendices 19 and 20.]

6. Recent revelations from the Tobacco industry clearly indicate that scientific research can be effectively corralled by vested private interests. We highlight that this private sector influence on the direction of scientific enquiry is widespread and emphasise that this does not allow for adequate and comprehensive assessments of new technologies/products. [See Dr Ruth Lawson’s Witness Brief.] Furthermore, public and environmental health does not appear to carry any real weight against such commercial interests. For example, “Secret history of lead”, J Kitman, The Nation, 20 March 2000. Leading corporations manipulated scientific research for vested financial interests to allow lead to be added to gasoline despite knowing throughout that ethanol provided a safe and effective alternative. [See Appendix 21.]

7. Various agrochemical companies used an amnesty with the US EPA during 1991 - 1994 to hand in over 10 000 studies or reports of adverse health effects from chemicals already on the market; these had never been reported despite the 1976 Toxic Substances Control Act (TSCA) making it a statutory requirement - some studies had actually been on company shelves since 1960.

8. Until this situation is addressed we consider the present research data fundamentally flawed and give precedence to non-industry linked scientific opinion. [See Appendices 22 and 23.]

9. It is interesting in his autobiography, Hericlitean Fire, that Dr Erwin Chargoff, disillusioned with the integrity and ability of scientists to self regulate GE in the public interest, suggested that it would probably end up requiring civil actions to procure such safety. At present there are five court actions and four legal petitions running in America. [See Appendix 16.] These include labelling GE food to lawsuits for various violations connected with this industry.

10. Extensive genetic pollution has occurred both in the UK and in Canada. In July and August of 2000 government authorities in France and Greece ordered the destruction of thousands of acres of GE soy, canola and cotton after discovering the imported seed shipments were contaminated.

11. Ironically, we now find many firms actually moving to GE-free countries to produce seed crops and avoid such contamination. [See document “Firms move to NZ” to Avoid Contamination.] GEF crops have also proven to interbreed and create “super-weeds” (32) a complaint that the industry had always been swift to dismiss.

12. There is still considerable ignorance of the effects of transgenic insecticides on the insect world. [See Dr. Ruth Lawson’s Witness Brief.] We found it strange that Dr Louise Malones [HortResearch Brief] found “Without exception, the outcome of these (GM) experiments have not been surprising ...” and yet further into her Brief goes on to say, “In contrast, (to the monarch caterpillar) the results of experiments which showed that a caterpillar-specific Bt toxin could harm beneficial predatory lacewings were surprising.” (31) We would simply add that this only serves to exemplify further the enormous hazards to which GE exposes our insect ecology. It is not sufficient to assure ourselves that, with further research, we could understand and possibly avoid problems. The mistakes may be too great and too late.

13. Also Dr. Malone’s comments on, “A fourth mechanism by which GM plants may exert

tri-trophic effects is at the population level.” We have grave concerns for any ecological effects which may alter population levels. She rightly points out that .specialist predators may starve and move onto alternative prey. This would also pose serious ecological disturbance problems. [See R Anderson’s Brief.]

14. The growing GE forestry plantations envisaged by giant corporations also give cause for anxiety as far as the New Zealand ecology is concerned. GE tree plantations could replace biologically diverse forests with fast growing, herbicide-resistant identical trees. Trees produce enormous amounts of pollen which can travel up to hundreds of kilometres.

Trees also distribute their genetic material through seed dispersal, regeneration from roots, runners and suckers - not to mention horizontal gene transfer (HGT) to fungi, bacteria, and viruses. Normal trees will inevitably cross with GE mutants (herbicide-resistant, fibre-altered, or endotoxin-spliced trees). These could crowd out natural forest flora, in turn killing off beneficial insects, decrease foods available for wildlife, and force tree pests into adjacent natural forest areas to wreak havoc.

15. Fast-growing GE trees (trees growing more than a meter a month which can be harvested in four years) use up tremendous quantities of water and are therefore likely to starve other trees and plants by depleting the water table. In addition, the leaves from Bt type endotoxins will create very noxious soil conditions, undermining the entire soil food-web and natural composting systems of the forest floor. The effect of this on rizospheremicroflora, among which Nitrogen-fixaters, pathogenics and antagonists, is not known. Scientists not indentured to this industry have warned that the enormous quantities of pollen generated by Bt-spliced and other trees are likely to cause major allergic reactions in humans.

16. The envisaged future use of the “Terminator” technology in GE tree plantations is also a cause for concern. Terminator trees, genetically engineered never to flower, could ensure a silent spring in the forests of the future. Such trees would grow faster than before, but will be devoid of the bees, butterflies, moths, birds and squirrels which depend on pollen, seed and nectar. A further hazard, not apparently considered by the Delta Pine Company in their Terminator work, is the lethal nature of barnase.

17. This is the enzyme Rnase from Bacillus amyloliquefaciens, normally lethal in the living cell, but produced in the bacterium with an inhibitor that is separated from the enzyme when it is excreted. Traces of this enzyme are toxic to the rat kidney (33) and to human cell lines. (34) Barnase is a key component in the “Terminator” construction where it is linked to a plant promoter active only in the cells of the tapetum (the sac which generates the pollen). During seed production barnase dust and debris, if breathed by humans, could cause severe toxicity.

In summary,we can say that our knowledge of GE trees is so sparse as to warrant banning this dangerous application of GE in New Zealand’s forests pending further research.

B (j) (iii)

There has been a complete imbalance in the allocation of scientific and health research funds in favour of the narrow view of molecular biology. Researchers working from a broader or more traditional perspective have tended to be ignored for the last two decades. Biological field scientists have increasing been unable to sustain their positions in major institutions in New Zealand due to lack of sufficient funding even to maintain basic functions. As a consequence, the commercial sector has been persuaded to follow an inappropriate path for which no sound future is guaranteed. This has had a severe impact on the knowledge base of New Zealand.

Companies involved in the export of organic apples are dismayed at the paucity of information about insect pests that are causing problems with the entry of product into the American market.

We oppose the present use of GE crops in commercial agriculture. The widespread dispersal of seeds and pollen combined with the inevitable mixing of GE with non GE crops during storage and handling means it would be impossible to guarantee either our non GE or organic products as GE-free. Our markets for both would be put in jeopardy.

1. We do not see any real cost to society by not pursuing GE agricultural practices. In fact quite the opposite as our organic markets grow from strength to strength in the knowledge that our produce will remain GE free.

B (j) (iv)

The cultural perspective of Maori which is radically different from that of western science has been given some weight in legislation and regulations concerning genetically engineering, but in the final analysis the values of life and spirituality that are unique to the Maori perspective have not held sway. The issues of disparity between these different perspectives will have to be addressed sensitively and fairly in the coming years. Dominance is currently afforded to the scientific perspective and technical considerations. Greater attention must be paid to the more general ethical and cultural concerns of Maori and the similar concerns of non-Maori.

1. The tensions between this technology and the ethical/cultural concerns is rather unique to New Zealand in that our founding document is the Treaty of Waitangi which must be honoured.

2. Ethics are foreign to the scientific point of view. Changing the genetic constitution of either a bacterium or a human is equally possible and both can be explained technically in terms of the material mechanism whereby the change can be accomplished. There is no right or wrong in this science, there is only what is possible, or impossible, according to the laws of Nature.

3. From the onset it is essential that the Commission bear in mind that for Maori to be Kaitiaki of their resource requires the Mauri of the resource to be protected. Failure to protect the Mauri of the resource results in the Kaitiaki losing their Mana status and possibly their Rangatiratanga. For these reasons we feel, quite rightly, that Maori will not sit by and watch their lands, rivers and forests irreversibly polluted by the products of genetic engineering. This may well became a growing problem if not addressed adequately by Government.

Section B (k)

B(k) the key strategic issues drawing on ethical, cultural, environmental, social and economic risks and benefits arising from the use of GM, GMO’s and products.

We see the key strategic issues arising from the use of GE and GEOs as:

1. The protection of the individual and privacy against invasion from public and private institutions.

2. The protection of diversity of cultural perspective and especially that of indigenous peoples.

The protection of the biosphere against the adverse effects of genetic engineering.

B (k)

1. PSRG is opposed to the patenting of genes and life processes. Taking patents on life forms and living processes is simply stealing from nature. This also takes advantage of the knowledge accumulated by indigenous communities and also by previous generations of western scientists who have worked for the public good. These patents threaten food security, violate basic human rights, compromise healthcare, impede medical research, and are against animal welfare. Biotech companies are only interested in exploiting the patented material for profit. Patents restrict ‘shared’ research.

PSRG also feel that the Crown has a responsibility to tolerate no diminution of the New Zealand biological diversity.

2. The patenting process has became a grave intrusion into many countries of the Third World. Biopiracy has also became a major concern for our Maori people. It represents a clear breach of trust to our Treaty partner to steal and patent their fauna and flora for profit. Their medicine plants are their heritage and as such must be left in their care. (See Witness Brief Dr Peter Wills.)

3. The patenting of living processes is deeply immoral and should not be allowed to continue. The identification of human genetic traits, their patenting and preserving in secret, has reached a terrifying level. Whole populations of indigenous people are being raided for their unique genetic information, without the slightest assistance offered to ensure their future survival.

4. Bearing in mind that for the Maori people to be Kaitiaki of their resource requires the Mauri of the resource to be protected the Commission should pay particular attention to these anxieties. Failure to protect the Mauri of the resource results in the Kaitiaki losing their Mana status and possibly their Rangatiratanga. Maori are very deeply concerned at the prospect of irreparable damage being caused by GE to their lands, rivers and forests

Section B (L)

B (L) the international implications, in relation to both New Zealand’s binding international obligations and New Zealand’s foreign trade policy, of any measures that New Zealand might take with regard to genetic modification, genetically modified organisms, and products, including the costs and risk associated with particular options.

Section B(L) Summary

New Zealand does not need to fear any international reprcussions from following a completely independent policy as regards genetic engineering. Whether pressure comes through diplomatic channels, action at the WTO, or from commercial sources we should follow our own imperative as we did in the case of our nuclear free policy. The greatest effect is likely to be an international public relations campaign on the part of those with a vested interest in genetic engineering to try and make New Zealanders afraid of pursuing a GE-free policy. Our stand against genetically engineered products will capture the imagination of our customers in Europe and elsewhere and further enhance our reputation as a source of safe and high quality food.

B (L)

1. It has been patently obvious that pressure from Trade Agreements such as TRIPS and the like have dictated Government policy on GE products and applications to grow them here in New Zealand. Constant warnings from PSRG and other scientists as to the imminent dangers of this technology have gone unheeded.

Existing international soft-law instruments

2. There are no binding international protocols or instruments regulating GEOs.

It is also certain that transnational corporations will continue to vehemently oppose such moves. The Royal Commission on Environmental Pollution of the UK, on The Release of Genetically Engineered Organisms to the Environment, expressed concern in its Report

(13^th, Cmnd. 720 July 1989) that restrictive regulation in some countries, notably of the industrialised West, would encourage companies and research institutes to take advantage of less strict frameworks of control elsewhere. This, it noted, will result in, “... a consequent risk to the environment and to the health in that country and more widely”. Indeed, there is evidence that this is already happening. Unregulated releases in countries where there is no scrutinization process to ensure safety have been taking place for some time now.

3. In 1989, for example, Monsanto had tested transgenic Roundup-tolerant soybean in the fields of Puerto Rico. (Roundup is a herbicide manufactured by Monsanto). Since 1991, it has been doing the testing in Argentina, Costa Rica and the Dominican Republic. Since 1992, Monsanto has been field-testing transgenic cotton in Belize and Costa Rica. The testing is in respect of tolerance to Roundup or to plants becoming insect resistant using the Bt toxin. Field-testing of transgenic cotton varieties is also planned for Brazil, India and Zimbabwe. Calgene released insect-resistant cotton and herbicide-tolerant cotton in Argentina and Bolivia in 1991. It plans to sell its transgenic cotton seed, tested as well in South Africa, Australia, Spain and Greece. It also tested its delayed ripening genetically engineered tomato, the “Flavr Savr”, in the fields of Mexico and Chile in 1990 and 1991 respectively. (Flavr Savr is now removed as a market failure, although other genetically engineered tomatoes followed.) Ciba-Geigy conducted their field trials of transgenic insect-resistant corn in 1991 in Argentina.

4. Greenpeace International has also documented illegal releases of genetically engineered micro-organisms (GEMs) in Argentina (a vaccina-rabies virus in 1986); Kenya (3 illegal cases since 1989, one involving ornamental plants from Argentina); India (80 different genetically engineered species of microbes imported from Japan and released into field crops); and Ireland (trials with a genetically engineered vaccine for use in fish were undertaken without the European Commission being notified - a clear violation of the EU directive on deliberate releases of GEOs).

5. All of these clearly illustrate the urgent need for very stringent protocols to control this technology. We urge the Commission to recommend this to Government at the conclusion of the Inquiry. The binding Directives of the European Community in respect of contained use and application, as well as releases of GEOs, are a clear precedent that binding documents on biosafety are both possible and desirable.

6. Moreover, the United Nations Environmental Program (UNEP) Expert Panel, set up under the Convention on Biological Diversity, (CBD) to consider the need for and modalities of a protocol, concluded on the need for a binding protocol, stating as its reasons, the following:

(1) Developing countries could be protected from being experimental grounds for the constantly occurring new developments in the field of biotechnology.

(2) Existing legislation in industrialised countries underscored the need for similar legislation in developing countries. International co-operation could be governed by a protocol. This would facilitate co-operation and avoid unilateral decisions.

(3) A protocol would have the advantage of harmonising existing legislation in the area of biosafety as well as facilitate the adoption of unified legislation for those countries without legislation. A protocol would also provide for legal redress in appropriate cases.

(4) A codification of a binding instrument would emphasise the importance of biosafety.

(5) Having national legislation in developing countries without capacity for oversight would merely encourage experimentation in these countries.

(6) A legally binding instrument would compel importers and exporters to recognise their responsibilities in relation to protecting the earth’s biodiversity.

(7) Ethical reasons require parties to take responsibility for their actions.

(8) A protocol could encourage co-ordinated international research on certain neglected areas, such as the transfer of genetically modified organisms, field-tested in temperate zones, to tropical ecosystems. This is particularly important because of the inadequacy of existing scientific knowledge.

(9) A harmonised system in all countries would help the industry by clarifying and standardising requirements.

(10) A protocol is essential to protect the environment and address environmental concerns. Countries arguing that there is no risk in transfers have themselves had legally binding rules on biosafety for a long time.

(11) A protocol could pave the way for safe technology transfers especially since the public is wary of the risks associated with this technology.

(12) Because of the known ability of organisms to cross national boundaries, harmonisation of national regulations through a protocol would protect against such transboundary damage.

(13) Implementation of the precautionary principle could best be done through a binding protocol. This would assist in preventing damage to biodiversity.

Section B (m)

B (m) the range of strategic outcomes for the future application or avoidance of GM, GMO’s and products in New Zealand.

Section B (m) Summary

Although New Zealand could follow the rest of the world and embrace every aspect of genetic engineering, it is in our far greater strategic interest to do what we can to maintain the pristine character of those parts of our natural and agricultural ecologies which have survived the excesses of industrial and technological onslaught.

Should genetic engineering of our foodstuffs proceed as envisaged by the major companies currently contributing to this technology, these companies will in effect establish the new level of commodity production. New Zealand’s interests will never be in the area of the production of commodities, but in the production of foodstuffs with the best credentials and the highest returns and, therefore, we should have no part in the ‘commercial genetic revolution’.

Any field testing of genetically engineered foods risks irreparable damage to the rapidly developing organic sector and it is that sector that offers the greatest possibility of providing good incomes for our growers and economic recovery for the entire country. All of the desirable outcomes of applying genetic engineering in medicine can be achieved without in any way compromising the GE-free status of the New Zealand environment, or of prejudicing the quality and standing of biological research in New Zealand.

B (m)

1. There has been a world-wide explosion in the demand for organic sustainable crops and our market for them is growing at an enormous rate. PSRG see no reason why New Zealand could not became one of the world’s foremost organic suppliers. Our isolated island status gives us a unique advantage over the rest of the world to be GE-free and maintain sustainable, organic methods of food crop production, to the advantage of our export industry.

2. PSRG agrees with Dr Max Suckling (Hort Research Witness Brief) that, “there seems to be little prospect of compatibility between organics and GM.” This idea, vigorously put forward by Biotech Companies, that organic and GE can co-exist, is total nonsense. Once GE crops are introduced into the New Zealand environment, the organic growers, together with our honey industry, will - on the evidence to date - be irrevocably destroyed. The Canadian export honey industry is virtually ruined due to GE pollution. New Zealand has a very valuable honey industry - already damaged by varroa - that would be further compromised by GE pollution of its products. As far as New Zealand is concerned an organic future is the most obvious course open to us.

3. The reasoning put forward by Dr Susan Gardiner (HortResearch Witness Brief) advocating GE in an effort to reduce spray is seriously flawed. We refer to the instance given that, “In the USA application of chemical sprays accounts for almost 13% of the cost of production of apples.” Dr John Clearwater has to date avoided most of these pitfalls and is getting premium prices for organic apples grown here in NZ. (See Witness Brief Dr .J Clearwater.)

Section B (n)

B (n) whether the statutory and regulatory processes controlling genetic modification, genetically modified organisms, and products in New Zealand are adequate to address the strategic outcomes that, in your opinion, are desirable, and whether any legislative, regulatory, policy, or other changes are needed to enable New Zealand to achieve these outcomes.

Section B (n) Summary

PSRG considers that there is inadequate statutory and regulatory control over genetic engineering in New Zealand.

Small scale experiments involving the use of laboratory microbes are not subject to satisfactory rules of containment especially in respect of disposal. Effects on the microbial flora of the environment are not adequately minimised under current procedures.

Forestry, horticultural and entomological genetic engineering should be restricted to fully contained facilities (for example, containment glass houses).

Ethically acceptable experimentation with mammalian transgenesis for medical and research purposes should be restricted to the minimal number of species, preferably only mice, securely contained in laboratory buildings.

Institutional bio-safety committees must be given constitutions that set their membership aside from any interests of those who apply to them. Bio-safety committees should have no more than 40% representation of active genetic engineers. And all members should declare their interests.

The HSNO Act must be changed so that weight is given to concerns within the community that arise from ethical and cultural perspectives, not purely from the consideration of technical details. This should apply not only to Maori perspectives, but also to religious and spiritual concerns expressed by many sectors of our community.

New Zealand should reassert its own sovereignty over the control of food safety and regulation. An appropriate regulatory authority would separate the interests of industry and consumers, and this could be done by having two separate bodies representing the conflicting interests which must be balanced.

Provision must be made for adequate representation of perspectives critical of genetic engineering to all representative bodies such as Committees of MORST, IBAC, the Royal Society, the ERMA, ANZFA, etc.

B (n)

1. Recommendation (i): That the Commission recommends to the Government the strategic option it ought to follow is one of encouraging further biotechnology research in strictly controlled laboratories which foster high quality science and rigorous evaluation of safety issues. The Commission should also recommend banning all genetically engineered crops from being grown on New Zealand soils. (See Witness Brief Robert Anderson.)

2. PSRG recommends the Precautionary Principle should dictate all research and innovative techniques of genetic engineering biotechnology. It is simply irresponsible to equate the risks of GE with those of conventional breeding programs. (See Submissions, Crop and Food, and HortResearch.)

3. Risk assessment and oversight of the HSNO Act by the ERMA does not provide protection to the environment or to the health and safety of the New Zealand populous. (See Witness Brief Dr B Conlon.) The ERMA has proved itself unable to regulate this formidable industry. By the applications accepted to date we cannot but infer that the ERMA encourage this dangerous technology entering New Zealand at any cost. (See Section B [e][6]) PSRG considers the current regulatory system under the HSNO Act is insufficient to regulate this extensive and insatiable industry.

4. Studies so far indicate that there is a forced alliance between science and big business. It is imperative that GE must be freed from the imperatives of corporate profit, which in the main works against the public good. (See Witness Brief Dr R Lawson.) Until some effort has been made in this direction it is hypocritical to assert that current GE research is “objective” and that citizens’ criticism constitutes an infringement of scientific freedom.

5. Part of this deception is the claim that the technology is not new, but just an extension of the selective breeding practices that have been carried out for decades. (see above ) In fact recombinant DNA (rDNA) technology and conventional breeding are worlds apart. Breeding does not manipulate genes, it involves crossing of selected parents of the same or closely related species. In contrast, rDNA technology artificially recombines genetic material between species that have very little probability of exchanging genes otherwise and while conventional breeding shuffles different alleles of the same genes, rDNA technology inserts completely new genes and gene combinations among or even within the genes of the host organism. To mediate these gene insertions vectors, usually derived from disease causing viruses, plasmids and mobile genetic elements, are used. Antibiotic resistance genes are used to act as markers. At the very least it is therefore misleading to suggest the two techniques are equivalent and incur similar hazards.

6. Recommendation (ii): The Commission should acknowledge that genetic engineering is inherently hazardous and that the Precautionary Principle should dictate all further GE work/research. Furthermore, GE technology is being used as an excuse to short-circuit billions of years of natural evolution by rewriting the genetic code of life in a language we simply do not understand. This represents crass irresponsibility.

REFERENCES

1. Henschke RB, Schmidt FRJ (1990) Plasmid mobilisation from genetically engineered bacteria to members of the indigenous soil microflora in situ. Current Microbiology 20, 105-110

2. Istock CA (1991) Genetic exchange and genetic stability in bacterial populations. In: Assessing ecological risks of biotechnology. Ginzburg, R. (Ed.). Butterworth-Heinemann, Stoneham, MA, p.123-150.

3. Schmidt F, Brokamp A, Henschke R, Henschke E, Happe B (1994) Möglichkeiten und Risiken der landwirtschaftlichen Nutzung gentechnologisch veränderter Mikroorganismen. In: Biologische Sicherheit/Forschung Biotechnologie. BMFT Germany (Ed.) Vol. 3, p. 985-1008

4. Spielman A, Regal P, Mundt C, Klinger T, Kapuscinski AR, Istock C, Ingham ER, Holmes M, Fagan, JB (1996) Draft - Assessment of genetically Engineered Organisms in the Environment: The Puget Sound Workshop Biosafety Handbook, Edmonds Institute

5. Stotzky G, Babich H (1994) Fate of genetically-engineered microbes in natural environments. Recombinant DNA Technical Bulletin 7, 163-188

6. Regal P.J., Scientific principles for ecologically based risk assessment of transgenic organisms Molecular Ecology (1994) 3:5-13. University of Minnesota.

7. Mellon, M and J Rissler. 1994. Perils Amid the Promise: The Ecological Risks of Transgenic Crops on a Global Market. Union of Concerned Scientists, Washington, DC.

8. (Kareiva, P., “Transgenic plants on trial”, Nature 363, 580- 1, 1993

9. Agricultural and Rural Development Committee, March 29, Dr Smith, Chardon LL maize.

10. Alvarez AJ, Yumet GM, Santiago CL, Hazen TC, Chaudhry R, Toranzos GA (1996b) In situ survival of genetically engineered micro-organisms in a tropical aquatic environment. Environmental Toxicology and Water Quality 11, 21-25

11. Bauda P, Lallement C, Manem J (1995) Plasmid content evaluation of activated sludge. Water Research 29, 371-374

12. Pukall R, Tschäpe H, Smalla K (1996) Monitoring the spread of broad host and narrow host range plasmids in soil microcosms. FEMS Microbiology Ecology 20, 53-66

13. Lorenz MG, Wackernagel W (1987) Adsorption of DNA to sand and variable degradation rates of adsorbed DNA. Applied and Environmental Microbiology 53, 2948-2952

14. Tschape, H. (1994). The spread of plasmids as a `function of bacterial adaptability. FEMS Microbiology Ecology 15, 23- 32.).

15. Salyers, A.A. and Shoemaker, J.B. (1994). Broadhost range gene transfer: plasmids and conjugative transposons. FEMS Microbiology Ecology 15, 55-22.

16. Commandeur, P. (1994), "Symposium: Patents, genes and butterflies." Biotechnology and Development Monitor, No. 21, p. 3-4.

17. <http://nbo.icipe.org> Pest management systems, and biological control.

18.. Tattersall RB Gill GV., Unexplained deaths of type 1 diabetic patients. Diabetic Medicine 1991 8: 49-58.

19. Thodarson H, Sovik O, Dead in bed syndrome in young diabetic patients in Norway. Diabetic Medicine 1995; 12: 782-87.

20. .SartorG, Dahlquist G, Short-term mortality in childhood onset insulin-dependent diabetes mellitus. Diabetic Medicine 1995; 12: 607-11

21.American Association of Physicians and Surgeons Newsletter, July 1999, page 1; 1601 N.Tucson Blvd., Ste 9 Tucson, AZ 86716.800-635-1196 www.aapsonline.org

22. Ibid

23. 58. Lorenz, M.G. and W. Wackernagel. 1994. Bacterial gene transfer by natural genetic transformation in the environment. Microbial Reviews, 58: 563-602.

24. Steffan, R.J. et al. 1988. Recovery of DNA from soils and sediments. Applied

Environmental Microbiology, 54: 2908-2915

25. Spring, S. et al. 1992. Phylogenetic diversity and identification of nonculturable mangeto-tactic bacteria. Systematics and Applied Microbiology, 15: 116-122.

26. "Consumer Involvement: A Dream or a Reality?" CERES newsletter,Winter 97/98, No 23.

27. Tattersall RB Gill GV., Unexplained deaths of type 1 diabetic patients. Diabetic Medicine 1991 8: 49-58.

28. SartorG, Dahlquist G, Short-term mortality in childhood onset insulin-dependent diabetes mellitus. Diabetic Medicine 1995; 12: 607-11

29. Monitoring field releases of genetically modified sugar beets for persistence of transgenic plant DNA and horizontal gene transfer. Fems Microbiology Ecology 1999 Vol. 28 (3) pp. 261-272

30.Garret.L“The Comming Plague” Chapt 13, Revenge of the germs, ISBN 0-14-025091-3.)

31. Hilbeck,A.Moar,W.J. Pusztai-Carey,M.,Filippini,A. andBigler,F.(1998a) Toxicity of bacillus thurengiensis Cry1Ab toxin to the predator Chryoperla carnea Environ. Entomol.27,1255-1263

32. 15.J. Pratley et al., “glyphosate Resistance in Annual Ryegrass” Proceedings of the 11^th Conference,Grasslands Society of New South Wales 1996; D. S. Gill “development of Herbicide Resistance in Annual Ryegrass in the Cropping Belt of Western Australia. Australian J. of Exp Agriculture Vol; 3., 1995 pp 67-72.

33. Ilinskaya,O and Vamvaka,S “Nephrotic effect of bacterial ribonucleases in the isolated and perfused rat kidney” Toxicology 1997, 120.55-63

34. 74. Prior,T Kunwar,S and Pastan,I “Studies on the activity of barnase toxins in vitro and invivo” Biocong Chem 1996, 7, 23-9

35. New Scientist, 4/7/98

Ends.

Information

Providing scientific & medical information & analysis in the service of the public's right to be independently informed on issues relating to human & environmental health.