In general, this report gives a balanced view, which I perceive is slightly generous to the Biotechnology and Industry based sectors; this is not surprising since this sector is so important to the Economy of Ireland. Where GMOs are retained in enclosed conditions, where there is a great deal of control, risks are not so great and there is often a huge amount of benefit to be obtained from GMOs, particularly in medical fields. Genetic engineering may help solve many genetic diseases, and produce many useful hormones and drugs in large amounts, often with less risk of rejection by human cells. However when GMOs are released into the environment into uncontrolled conditions, where they can not easily be recaptured or restrained, there is a much greater risk of things going wrong. I am not anti-Biotechnology, and believe it can often be of great benefit, but realise there are many potential problems where we can not even assess all the possible dangers and I think we need to adopt the precautionary principal, and legislate for more safeguards than exist at present, even at the expense of slower growth in industry. In addition, the general public, including Euro MPs, need to be educated in the risk evaluation of GMOs. I will only discuss this topic in relation to the environment, and this booklet; leaving medical and ethical matters to others.

For brevity, I will not comment on most of this well researched booklet, only on areas where I think there could be improvements, or where I feel there have been omissions. Where I do not make comments it can be taken that I agree with the authors views. I hope this approach does not make my comments appear very negative, as I am generally in favour of advances in biotechnology. The sections in the book relevant to topics I discuss, where changes could be made, will be listed in bold letters and numbers.

The benefits of genetic engineering are obvious in many instances, but are not without hazards, especially when big business becomes involved, where making big profits may become more important than the health of people or the environment. It is impossible to predict with complete accuracy what the ecological consequences might be of releasing genetically engineered organisms into the environment. It is always possible that the delicate balance that exists in any habitat may be irretrievably damaged by the introduction of organisms with new gene combinations. It is also possible that organisms designed for use in one environment may escape to others with harmful consequences. We know that viruses can transfer genes from one organism to another. Advantageous genes added to our domestic animals or crop plants may be transferred in this way to their competitors, or by them crossbreeding with closely related species, making them even greater potential dangers. The escape of a single pathogenic bacterium into a susceptible population could result in considerable damage to a species. Even in a small controlled experimental release, it may not be possible to recall or destroy all the released organisms or progeny produced, after the experiment. Pollen, spores, seeds, etc which are produced may be so light that they are blown thousands of miles from the source; they may be eaten and taken by birds which fly hundreds or thousands of miles before depositing them. They may also be widely distributed by insect and mammal vectors, or by flowing water and marine currents. The marketed GMOs, possibly carrying dangerous genes, cancers, or pathogenic organisms, may be marketed, using aeroplanes for rapid transport over thousands of miles. Thus we need to be careful on a global scale.

One potentially hazardous topic that has not been mentioned in the book is the possibility of accidentally transferring, genetic or other chemical material from one organism to another while transferring genes. Retroviruses (e.g. the well known Human Immunodeficiency Virus (HIV) which causes AIDS (Aquired Immune Deficiency Syndrome) ) may have devastating effects on organisms living in an environment. The genetic information in retroviruses is RNA. While many viruses possess RNA, retroviruses have the enzyme reverse transcriptase which can be used to synthesise DNA from RNA, the reverse of the normal transcription process used to produce enzymes and proteins according to a genetical plan. The Same enzyme is used in genetic engineering. The DNA form of the retrovirus genes is called the provirus and can be incorporated into the host’s DNA. Here it may remain latent for long periods before the DNA of the provirus is again expressed and new viral RNA produced. During this time any division of the host cell results in the proviral DNA being duplicated as well. In this way the number of potential retroviruses can proliferate considerably. This explains why individuals infected with HIV virus often display no symptoms for many years before suddenly developing full-blown AIDS. When incorporated into the host DNA the provirus is capable of activating the host genes in its immediate vicinity. Where these genes are concerned with cell division or growth, and are ‘switched off’ at the time, their activation by the provirus can result in a malignant growth known as cancer. The RNA produced by these newly activated genes may become packaged inside new retrovirus particles being assembled inside the host cell. This RNA may then be delivered, along with the retroviral RNA, to the next cell the virus infects. This new cell will then become potentially cancerous. Retroviruses thus can cause dangerous diseases or cancer, but most are harmless. Some proviral DNA has become such an integral part of the host-cell DNA that it is passed on from one generation to the next via the gametes and is, in effect, part of the host’s genetic make-up. Such a virus is referred to as an endogenous virus. Endogenous viruses may be harmless in their host organism but very dangerous to another organism if transferred into it accidentally when transferring other genetic material. Many researchers think that many virulent new diseases develop due to close proximity of different species potential host organisms (e.g. Asian Flues, due to humans living close to pigs in the Orient). Prions, a type of protein that can reproduce itself by mechanisms that are poorly understood , may be implicated in the association of BSE mad cow disease in cattle, with CJSD Kreutz-Jacob Syndrome Disease in humans, through humans eating infected beef , often where cattle were fed ground up bone meal of other cattle. How much easier would these chemicals be transferred if either or both organisms had genes or cells removed or added to them or transferred between them, using genetic engineering techniques?

Add to Non Technical Summary 1.6 , Part I iv (Page 3), Part III 3.16, & Part V 10 :

The possibility of transferring, deliberately, or more likely by accident, endogenous viruses, prions, genetic material, DNA, RNA, on /off genes and cancers, or other significant proteins (toxic, or stimulating an allergic response) from one organism, where they are harmless, to another, where they are harmful.

There are not enough controls. Patents protect the rights of industry; but individuals have little rights, for access to information themselves, or to allow independent scientists to assess release proposals for them.

It takes many years to note the affects of loss of biodiversity due to GMO out-competing other varieties of the same organism either in the environment or as products on the markets. By the time loss in biodiversity is recognised it is too late to withdraw the GMOs.

Should introduce concept that ‘polluter pays’ compensation for any damages caused. This will make companies think twice about taking short cuts, to save money, in the research and testing procedures they undertake before releasing organisms into the environment. They might also try to develop ways of introducing sterile organisms, or single sex species (for species that only reproduce by sexual means) into the environment. The precedence for this is already set in pollution legislation Annex I Part 3 Title XVI Article 130 r (Page 50). This is only fair as these companies stand to make huge profits if their GMOs work, and they may not be too worried about local people or environments. This will not be a complete safeguard, though, as companies faced with a big bill will declare themselves bankrupt, close down, and open under a new name. But it should prove to be a deterrent, because larger multi-international companies, with large amounts of assets might find it hard to convince the courts that they are bankrupt.

I would question are politicians competent. I would suggest that environmental scientists, especially environmental biologists have enough knowledge to give judgements on the dangers of deliberate releases.

Should also include a section on transparency in politics. Recently our Euro MPs voted on complex issues relating to patenting of GMOs without any debate in Ireland (especially not on Television) and without informing the public personally or otherwise. Most parties supported industry with little thought about safeguards for the Environment (see letter I wrote to the Minister for Justice at the Time: I also wrote to all our Irish Euro MPs at the time, with little response except from the Green party, and Labour). RTE were very poor in stimulating debate in this matter. Perhaps they do not have enough environmental science journalists that can understand this topic and educate the public in this field.

1. Balancing is not the correct word to use here (i.e. balancing environmental protection with economic growth) Environment and health should always come first. Only very small risks should be accepted and polluter should always pay for clean up after damages.
2. What about unidentified risks. Proportionality is O.K., but must be stringent; once something is released it can not be taken back.

5. Balancing environmental risks and benefits is fine; but once biodiversity is lost it can not be got back easily
6. Also need transparency of Politics.

Many GMOs are designed to tolerate more herbicides or pesticides.

‘The Commission will normally follow scientific advice. In exceptional cases, however, it reserves the right to a different view in the light of its general obligation to take into account other Community policies and objectives’. What does this mean? Why would the Commission ignore scientific advice?

I am saddened and annoyed that the commission would consider putting business and trade policies before the health of humans, animals and the environment, and that they think they know better about the environment than environmental scientists; especially environmental biologists (ecologists) when concern is expressed by these scientist! Where is concern for ‘safety, quality and efficacy’, if they can be overturned by the wheeling and dealings of politicians (possibly influenced by the money of big business).

Will the Commission ensure that all decisions in the field of biotechnology will be in conformity with international obligations, in particular with provisions resulting from World Trade Organisations negotiations – even at the expense of health of human and animal communities, and/ or of biodiversity; or breaking the rights of member states, fortunate enough like Ireland to have natural barriers, of introducing quarantine regulations? This is a case of the tail wagging the dog. Does Trade takes precedence over health and safety? No chance for individual states to protect themselves from possible localised diseases or dangers by introducing quarantine regulations.

The risk levels of GMO products are only tested in one country . There may be different environmental conditions in different countries or regions which could significantly influence results. One-door-one-key policy where one main competent authority acts as "gateway "should only apply where similar ecological conditions exist in the different regions chosen for release.

Is an organism with 1 or 2 different genes a new invention? How novel does a process have to be when inserting or deleting a gene, to qualify as novel or inventive technology? There is a certain amount of inventing the rules to suit the occasion; and for economic protection of companies which undertake costly research. I understand and support the need to protect research, but at times I feel the logic is a bit twisted. As a biologist I also wince at the prospect of large corporations owning a significant proportion of life on earth at some distant point in time, when diversity of varieties is reduced, due to the bred in increased competitive nature of GMOs, ecologically or economically. (The 10 year ? periods for which patents operate may help here, but a lot of damage to the environment, or decrease in biodiversity can happen in 10 years). There are ethical factors involved. Is it right for First world companies to patent species of crops from third world countries that have been looked after, nurtured and bred for thousands of years to increase productivity by the populations in these countries; just because they have added a gene, that makes a single step change. Changes may only lead to profits for big seed suppliers from First world countries, and not the peasant growers from Third world countries. Often the gene changes will allow the use of more expensive fertilisers, herbicides, or pesticides; supplied by large first world corporations. Either the land or the farmers themselves can then become dependant on these products or in debt to the suppliers. The USA has even threatened with-holding Aid of seed supplies in conflict situations with some third world countries (mostly central American Communist regimes in tropical regions); from the very regions (with much higher natural diversity than temperate regions) where the crops evolved in the first place. It is often the consumers that take all the risks of GMOs whereas it is often the producers or suppliers that make all the profits, after increased mechanisation, or intensity of production of more uniform crops or livestock or organisms. Sometimes royalties can be too high for vital medically orientated products based on GMOs, desperately needed in deprived regions.

The Directive was passed through the European Parliament on 12 May 1998, supported by most of our Irish Euro MPs with hardly any debate in Ireland. The Irish public were given no chance of becoming informed, or voicing their opinions. I wrote to all Irish Euro MPs, expressing concern at possible sources of risk, and later to the minister for Justice. I received little more than an acknowledgement letter (often written by a secretary) or nothing at all from most of the politicians. Pat Cox wrote a pro business patronising letter, saying that I should not use emotive terms such as ‘patenting life’, that it was rely patenting inventions! The Green party and Labour and John Hume acknowledged that there were still some potential problems, and voted against it.

The Directive acknowledges existing differences in the protection of biotechnological ‘inventions’ in the Member States, and addresses these on the grounds that they could create barriers to trade and impede the proper functioning of the internal market. It aims at harmonising national regulations and jurisprudence on patenting in the field of biotechnology. This is all very laudable provided that trade is not seen as more important than the environment or health. ‘In general requirements for patentability are the same for all types of inventions’- as long as we are clear what inventions are in terms of varieties of living things, with possibly only one extra gene.

1. ‘Biological processes for the production of plant and animals would not be patentable’

3. Case-by-case principle, and step-by-step principle is fine but it should be specified what length of time that each step should take, based on mandatory number of generations that are assessed in enclosed captivity, looking at levels of diseases, viruses, prions, toxins, and competitiveness associated with the GMO, prior to small scale release experiments; initially of
4. ‘For the purpose of the Directive "organism " means any biological entity capable of replication or of transferring genetic material’. Is this by any or all means? Does it include non-normal means, such as by transduction. ‘It does not cover naked rDNA and naked r-plasmids.’ Can these not transfer genetic material? Cell organelles like mitochondria and chloroplasts contain genetic material , so does DNA strands in the nucleus and and t RNA and rRNA in the cytoplasm of cells and ribosomes free in the cytoplasm and attached to the endoplasmic reticulum. What about prions?

7. What about insisting on public notification as well as to the appropriate competent authority (as stated later in 4.13, but which has not taken place in Ireland to any great extent, see what I said about the debate on patenting legislation (Part III 3.6 Patenting); This booklet is one of the first attempts I have come across at involving the general public in this debate)
8. A comprehensive risk assessment should be provided to the general public and independent scientists in a region for evaluation (Public Notification), in addition to competent authorities stipulated at present.
9. Agree that greenhouse and laboratory tests have little validity but beware that in field conditions however small the scale of the tests, pollen, seeds and spores (e.g. bacterial, fungal, or of ferns) may be spread over thousands of miles by wind, insects, birds, water currents and other vectors. Ideally should release, for several trials at least, sterilised or infertile progeny, or triploid organisms, or all female or all male lines, e.t.c. Plants can also spread by sub surface vegetative, or assexual reproduction (e.g. by runners), which may not be very visible. All the planted crops or their f₁ generations should be destroyed after plot experiments end, while results are being evaluated, and the ground turned over and treated to find and destroy all examples of the GMOs.
10. Multiple releases (i.e. of a combination of GMOs on the same site or of the same GMO on different sites for the same purpose) within a limited period of time may be treated as a single notification; but may make it harder to decipher what organism or what release causes what effects; but additive or synergistic effects may be noted. Should try combinations only after individual GMOs have been individually released and tested; no short cuts – after release organisms cannot be recalled if things go wrong.

12. Agree that in every case where a release is carried out, the notifiers must provide the competent authority with the results in respect of any risks to human health or the environment. But also should provide the information to the general public and independent scientists; should also take steps listed above (by me in 4.9) to stop spread of progeny, and should clean up any mistakes; polluter pays principle.

4.27 Transparency.

29. In addition to biotechnology company assessment, of safety of GMO releases, prior to each release there should also be included an assessment made by at least one independent environmental scientist.
30. Article 16 of the Directive provides that, where a Member State has justifiable reasons to consider that a product for which marketing consent has been granted constitutes a risk to human health or the environment, "it may provisionally restrict or prohibit the use and/or sale of that product on its territory." What is meant by the term provisionally, and for how long does it apply? Can it apply indefinitely?

2. Fees payable to the EPA in respect of notifications submitted under the Regulations, and related charges. Are there common fees of a similar level for all states, or is it cheaper (or easier) to get consent in some states than others, and then use the common gateway approach to grow or market in all EU states.

6. Risks involved are often not well defined or known, long term.

It is fine to build public confidence if the product is safe both to the public and the environment. The biotechnical regulations must ensure that control requirements are always appropriate to the health of the public and the environment. Building of public confidence is important, but subsidiary to health of public and environment and should only be persued if the product is safe. The competitive development of the industries involved is important, but only if all of the above is correct. However, I suspect this will be the main controlling factor in an environment where market driven philosophies prevail.

7. I rely can not understand much of this section; especially the "light procedure".

7. Review of Directive 90/220/EEC

1. * insufficient clarification concerning the objectives for risk assessment. True!

4. Main elements

1. Should define what are these direct and indirect environmental issues talked about.
2. Limit marketing consent for individual products to a fixed period of seven years; should add "or less if detectable and documented environmental or health problems arise"

• effects on population dynamics within the receiving environment; add " of all common species present"
• effects resulting from the transfer of the inserted genetic material to other organisms; add "deliberate and accidental, e.g. endogenous viruses, cancers, regulatory genes, prions, DNA, RNA, e.t.c."

1. It is important not to discount any hazard on the basis that it is unlikely to occur. Good point !
2. For each hazard identified, the effect of the environment on the likelihood of the hazard being realised and the extent of the consequences should be considered: highlights difficulties of one-door-one key policy approach, where different environments are treated as one.
3. It is true that a major factor in determining the likelihood of a hazard being realised is the characteristics of the environment into which the GMOs is intended to be released. But there may be other factors or exceptions; e.g. spread of a GMO or another organism that picks up some of the genetically modified genes of the introduced organism (e.g. by interbreeding or by transduction) may be greater in an open environment; but effects noted may be greatest in a single closed environment
4. Estimation of the risk posed by each identified hazard; I suspect we do not even know of some of the potential hazards.
5. GMOs or conditions of release can be modified to reduce risk ; e.g. release sterile organisms, in weather conditions not conducive to their spread (e.g. low winds); but even then accidents can happen; some may not be sterile due incomplete treatments.

Small levels of surviving progeny may breed rapidly if there is little inter-specific or intra-specific competition, or absence of suitable predator species.

6. Determination of the overall risk of adverse effects. Risks may have additive, multiplicative, or synergistic effects. One would need to know which was the effect in each case to get a realistic estimate of the total effects. It may not be possible from past experiences to be sure which case would apply.

4. Where a proposal to grant consent for the marketing of a genetically modified product is not endorsed by qualified majority support in the Article 21 Committee, the commission must submit its proposal on the notification to the Council for a decision. As in the case of the Article 21 Committee, Council acts by qualified majority, i.e. it may endorse a Commission proposal by qualified majority. Unanimity is required to reject a proposal. I feel that a qualified majority should be sufficient here to reject a proposal.
5. Where the Council fails to act on a proposal within 3 months, i.e. fails to endorse it by a qualified majority, or to agree unanimously to reject or amend it, the proposal must be adopted by the Commission. I feel the precautionary principle should apply here and the proposal must not be adopted by the Commission. In addition I feel it should only need a qualified majority to reject it.

1. Under article 15 of the Deliberate Release Directive, a Member State may not, on safety grounds related to the protection of human health and the environment, prohibit, restrict or impede the marketing of a genetically modified product which complies with the marketing requirements of Part C of the Directive. This is ludicrous. A Member state should be allowed to protect its own populations health and environment. It should be allowed to prohibit, restrict or impede the marketing of a genetically modified product for these reasons.
2. However, Article 16 provides that, where a Member State has justifiable reasons to consider that a product for which marketing consent has been granted constitutes a risk to human health or the environment, "it may provisionally restrict or prohibit the use and/or sale of the product on its territory". I feel the word provisionally should be deleted here.

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