I welcome Ms Mary Jackson and Mr. Paul Cantwell, from the blood policy division of the Department of Health and Children, and Dr. William Murphy, the national medical director of the Irish Blood Transfusion Services. I ask that they brief the committee on COM (2004) 80 and state the opinion of the Commission on the European Parliament's amendments to the Council's common position on the proposal for a directive of the European Parliament and the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells, amending the proposal of the Commission pursuant to Article 250/2 of the Treaty. COM (2004) 80 is an amended text of COM (2003) 340. I ask Ms Jackson to commence.
Scrutiny of EU Proposals.
Ms Mary Jackson
This directive was passed in Council on 2 March 2004. It is a very good legal instrument in that it will set minimum standards throughout member states on quality and safety with regard to the donation, procurement, testing, processing, storage and distribution of human tissues and cells. It follows in the tracks of the Blood Directive 2002/98/EC, which was adopted last year and which must be transposed in Ireland by February 2005. Both of these areas - blood and tissues and cells - were covered by Article 152 of the European Treaty which is aimed at safeguarding public health. The directive covers all tissues and cells, except hair and nails. it does not cover organs because it was felt by the Commission that further scientific analysis needed to be done on the balance between safeguarding the supply of these organs and safeguarding public health. The Commission has agreed that it will carry out a scientific technical analysis of organs with a view to returning to Council with a proposal on another directive or further regulation on organs.
The direction must be transposed into Irish law by April 2006 and we have two years to implement the directive in our tissue establishments in Ireland. One may ask what is covered by the term "tissues and cells". It covers skin, bone marrow cells, bone, adult stem cells, as well as stem cells generally. It will cover activities where hospitals or other agencies are engaged in the range of testing, processing, storage and distribution of these tissues and cells.
It follows the same track as the blood directive, where a competent authority will be established that will issue a licence or accredit all of the establishments dealing with tissues in the country. This can only be good news because it will guarantee the safety and quality of what is happening in these tissues and cells establishments. In the note I circulated, I gave a list of areas that will be covered under the accreditation procedure. The licence will have to specify the activities that will be undertaken in tissue establishments and they will not be able to commence new activities unless they contact the competent authority and get approval to do so. If the tissues and cells are transported from one facility to another, the other party also will have to be covered by this licence. It will involve tracing and a donor identification system, so that if at a future date following donations, an infection arises, the donor will be traced and action will be taken. By law, records must be kept for 30 years in all of these establishments and those who do not adhere to the directive will suffer penalties. With a competent authority accrediting these facilities, if they do not meet the requirements under the directive, they will be closed if they do not improve their activities.
There are other features of the directive not directly related to the accrediting of the facilities. There must be mandatory consent prior to the removal of any tissues and cells from a person. Such consent follows proper information on what is involved having been provided to both the donor and recipient. It is mandatory, so it will come into law. At present, under an ethical guideline, consent must be given prior to the removal of tissues and cells, but following implementation of the directive this will be law.
Member states must encourage voluntary unpaid donation. Data protection will be ensured and a minimum qualification will apply to those who run all of these facilities. A requirement is that in all documentation, there must be standard operating procedures which must be inspected by the competent authority. There must be quarantine periods before testing and before the donations can be used. Labelling, documentation, packaging and distribution standards must be met. That is a short overview of the implications of the directive for Ireland and other member states. It will guarantee that throughout the European Community, public health is assured in regard to tissues and cells.
I thank Ms Jackson for her most comprehensive outline. Are there members offering?
How is this received generally by those involved in research? Do they welcome the directive as a measure that clarifies their position or do they regard it as a barrier to future research? I imagine that donor traceability and so on would be very welcome. Am I correct in thinking there is some opposition to it?
Ms Jackson
Ironically the directive does not cover research, it is for human applications only. It is where the tissues and cells are transferred from one human being to another and it is quite distinctly that. Research is excluded from the scope of the directive. Tissues and cells that will be used for research purposes only are excluded from the scope of the directive. There was quite a lot of discussion and Dr. Murphy will confirm this. The health group working on the format of the directive and the Parliament in discussions with the Commission afterwards all agreed that the area of research needs its own legislation. This applies to human application, for transplantation mainly, so research is excluded.
Does it exclude organs?
Ms Jackson
It excludes organs, as well.
It is fairly specific.
Ms Jackson
It is, yes. That is why in the definition of tissues and cells, I mentioned skin, bone marrow, haemeopoetic blood cells and corneas.
Is there any involvement in the pharmaceutical industry? We have experience where the pharmaceutical industry has taken human tissue for particular purposes. Is that covered? Ms Jackson mentioned a competent authority. Is she talking about the establishment of a new authority solely for this purpose at a time when the Minister is wiping out a whole range of agencies and authorities?
Ms Jackson
Yes. We will need a new competent authority. Prior to the blood directive coming into place the only facility that was inspected under Irish legislation by the competent authority - which for blood, at present, is the Irish Medicines Board - was the Irish Blood Transfusion Service. In the context of implementing the new blood directive, up to 65 blood banks will be required to be inspected by the IMB under its broader remit. The Department is still in discussions about what the competent authority will be for tissues and cells. We did a check and we reckon there are probably about ten tissue establishments in the country, so the question is whether the competent authority would be the IMB or another entity. It will be new work.
Are there commercial interests?
Ms Jackson
The Deputy's second question was about manufactured products. Where human tissue and cells are used as the starting products in these processes, the procurement, testing and storage will be covered by the directive. Once they become a manufactured product - once the processing occurs - they will be covered under other EU legislation for medical devices or medicines.
On the question of paid and voluntary donations, are we also talking about money changing hands in some cases? Is that also covered in the directive?
Ms Jackson
One recital at the beginning of the directive - I cannot remember offhand which one it is - notes that there will be a facility for people who are put out of pocket by coming to the location to donate. The spirit of the directive is that payment would only cover out of pocket costs relating to the donation of the tissue and cells in question. There was quite a debate about this and I do not know if Dr. Murphy wishes to comment on it.
The reason I am asking is because I know the donation of blood is paid for elsewhere, but in this case is Ms Jackson saying there will be no payment for tissue donation or anything like that?
Dr. William Murphy
It is not precluded by the directive that people involved in the collection of the donation would make a profit. It is frowned upon but it is not precluded.
It is not precluded?
Dr. Murphy
No.
I welcome the departmental delegation. Regarding embryos, Ms Jackson mentioned adult cells but are embryo stem cells also included?
Ms Jackson
They are, yes.
There seems to be some contradiction here because we had a controversy over the collection of embryo stem cells. Is Ms Jackson saying that embryo stem cells will be allowed to be collected from foetuses here in the Republic? Is that the case?
Ms Jackson
No. As the Senator can appreciate, the practices in the UK are very different from practices in Ireland at present. Where member states engage in particular practices that involve embryos, for human application - where the embryo would be transferred from one human being to another - that will and must be covered by legislation. An important point of this directive is that it allows member states to make their own laws which can be more stringent and ban whatever practices they wish. Therefore, Irish Law, including the Irish position on embryos, is safeguarded.
So there is definitely no change whatsoever concerning this?
Ms Jackson
No, it is emphatic. Article 3 of the directive makes it clear that member states may put in place more stringent legislation to safeguard their own positions.
Will it require primary legislation here to bring in embryo research, or is it done by a departmental directive?
Ms Jackson
The committee has already heard the representation from the Department concerning stem cell research. The report of the Commission on Assisted Reproduction is awaited in order to further the discussion in Ireland on all areas of embryology and human assisted reproduction. In Ireland, the process of examining what type of law needs to be put in place is under way. Regardless of that, any such practices - for example, in vitro fertilisation, where a woman undergoes a process and the egg is replaced back into her body - would be covered under this legislation. If it involves the transfer of cells from one human being to another - if somebody donated an egg that was implanted in someone else - it would be covered by this legislation.
I have no doubt that Ms Jackson's contribution this morning will cause some controversy concerning the whole area of embryonic cell research.
It will not.
Ms Jackson
No, the directive——
It allows for it.
No.
It allows for it.
Ms Jackson
No, it does not allow for research. Where the practice of implantation takes place, the directive comes into play, but it does not cover strict research in vitro, in test tubes or whatever.
Thank you for your clarification.
When was the directive adopted by the Council?
Ms Jackson
On 2 March 2004.
When was the measure first presented by the Commission?
Ms Jackson
It was first presented in 2001. It reached the second reading stage in mid-2003. It only came before the EU scrutiny group on second reading stage because the EU scrutiny group came into place after the directive had already commenced work at Commission level.
I am a member of the scrutiny sub-committee but does Ms Jackson know on what date it came before that sub-committee or when it was sent to the scrutiny sub-committee?
Ms Jackson
It was sent within a month of coming to second reading stage, which would have been in mid-2003.
I am pointing that out because I am wearing my scrutiny sub-committee hat. The directive has now been passed so in a sense we are discussing something after the horse has bolted from the stable.
That happens to all committees. Do members have any recommendations they would like to see included in the EU scrutiny report on the proposal? No. I thank the witnesses. They may wish to keep the committee informed when the directive is being transposed into Irish law.
I now welcome Mr. Eddie O'Reilly and Ms Celeste O'Callaghan of the finance unit at the Department of Health and Children. I will ask Mr. O'Reilly to brief the committee on: COM (2003) 831, an amended proposal for a regulation of the European Parliament, and the amending Council regulation EEC/1408/71, on the application of social security schemes to employ persons and their families moving within the EU; and Council regulation EEC/574/72 fixing the procedure for the implementation regulation 1408/71 in respect of the alignment of rights and the simplification of procedures. COM (2003) 81 is an amended text of COM (2003) 378.
Mr. Eddie O’Reilly
Thank you, Chairman. No. 1408/1971 is the regulation dealing with the co-ordination of social security schemes throughout the EU. No. 574/1972 is the associated implementing regulation. The regulation gives entitlements to benefits in kind - in this case, health care - while on a temporary stay in another member state.
There are various temporary stay forms. E111 is very familiar to most people and deals with holiday makers and other short-term visitors. E128 deals with posted workers, who are people sent abroad to work by their employers and students who go abroad for a course of study. E119 covers job seekers, those who can go abroad and look for work, at the same time receiving health care as necessary. E110 covers international transport workers. Those various forms currently convey different levels of entitlement to health care while on a temporary stay abroad.
Currently, within the E111 category, only pensioners have the greater entitlement of necessary care. They share that entitlement with the other categories just mentioned - posted workers, students, job seekers and international transport workers. That leaves the vast majority of travellers - non-pensioner holiday makers and other short-term visitors, with the more restricted entitlement to immediately necessary care. The amended regulation coming into force from 1 June 2004 levels up the entitlements for the different categories of persons during a temporary stay. That alignment relates to benefits in kind which become medically necessary during their stay in the territory of one of the member states, taking into account the nature of the health care and the expected length of the stay. The necessity to have different forms for a temporary stay is therefore removed, and the European health insurance card can replace all those temporary stay forms from 1 June 2004.
There is a further simplification, in that people who become ill or injured while on a temporary stay can now go directly to care providers with no requirement at the outset to contact the local equivalent of our health boards. That is the case currently in such countries as Germany and Austria. Of course, that does not affect people travelling to Ireland, as we have always had direct access to care providers.
There are two smaller changes regarding the obligation to inform people of their rights and the requirement that care providers and institutions contact each other with a view to ensuring that people who need health care while on a temporary stay are inconvenienced as little as possible.
I notice from the brochure that a card does not entitle one to travel abroad with the aim of getting health care through the public system. How is that prevented?
Mr. O’Reilly
It is essentially a decision for the medical practitioner abroad. He or she must decide, if one turns up for treatment, how long one is staying. As a traveller abroad, one must assure the provider that one is not travelling for the purpose of receiving treatment.
Will they simply make a decision on that?
Mr. O’Reilly
Yes.
The answer to that is to introduce a constitutional amendment, as proposed by the Progressive Democrats. Yesterday everyone received a document from the Minister for Social and Family Affairs stating that entitlements would not be granted to people here unless they had been working and living here for two years, which seems extremely restrictive. How does this relate to that requirement? Is health care exempt? It seems to be at variance with what is happening now regarding tightening things up.
Mr. O’Reilly
Does the Deputy mean people travelling to Ireland as such? In practice, they would be treated. We do not refuse treatment to anyone. That is different, and I cannot speak for the Department of Social and Family Affairs, but it may or may not happen that one requires health care. With benefits in kind regarding social security, one is talking about regular payments and so on.
It is separate.
Mr. O’Reilly
Yes.
Will the same card be available in every country in the European Community? Why is it only for two years? That does not seem to be much of an improvement.
Mr. O’Reilly
There are plans to extend the use of the card, perhaps with smart card technology, depending on how it goes. It will be reviewed fairly shortly, probably early in 2005, with a view to extending the use of the card. At present one might call it dumb plastic.
It will be smarter.
Mr. O’Reilly
Yes, it will essentially be a smart card.
I thank the members of the delegation for a very comprehensive briefing on COM (2003) 831. I trust that they will inform us when it is transposed into law.
Mr. O’Reilly
On 1 June 2004. We have a website at www.ehic.ie.
We will now turn to COM (2004) 10. I welcome Mr. Éamon Corcoran and Ms Róisín Cahalane of the food unit at the Department of Health and Children, Mr. John Downey of the Department of Agriculture and Food and Dr. Pat O'Mahony of the Food Safety Authority. I ask them to brief the committee on COM (2004) 10, a proposal for a Council decision authorising the placing on the market of sweetcorn made from genetically modified maize, Bt11, as a novel food or food ingredient under regulation EC No. 258/1997 of the European Parliament and of the Council.
Mr. Éamon Corcoran
My colleague, Róisín Cahalane, will be leading on this.
Ms Róisín Cahalane
Thank you, Chairman. The proposal referred to was submitted by the EU Commission to the Council on 28 January 2004. As is required under Oireachtas scrutiny provisions, the proposed decision, along with an information note, was submitted to the Oireachtas Joint Committee on European Affairs on 25 February 2004, within the time period set.
I will give members a brief overview of the proposal and the background to it. On 11 February 1999, the company Novartis, now called Syngenta, submitted a request under Article 4 of the novel food regulation EC No. 258/1997 to the competent authorities of the Netherlands to place sweet maize or corn from a genetically modified maize line, Bt11, referred to as Bt11 sweetcorn, on the market as a novel food or food ingredient. A novel food is any food or food ingredient not marketed to a significant degree within the European Community before May 1997. During the assessment process by member states, objections to the marketing of the product within the EU were raised. Consequently, a community decision requiring the support of a qualified majority was necessary to approve the application. The EU scientific committee on food delivered an opinion in April 2002 stating that the Bt11 sweetcorn was as safe for human food use as its conventional counterparts.
The EU operates a decision-making system known as comitology, which is set out in the brief prepared by the Department of Health and Children and circulated to members. Under EU comitology rules, the proposal to authorise Bt11 was originally put to the standing committee on the food chain and animal health for a decision. That committee is regulatory and consists of representatives from member states chaired by the Commission. The committee's mandate covers the entire food supply chain ranging from animal health issues on the farm to the products that arrive on the consumer's table.
To grant Community authorisation, a draft Commission decision was submitted to the standing committee on the food chain and animal health on 8 December 2003. However, the necessary qualified majority of 62 votes out of a possible 87 either for or against the proposal was not achieved. The result was as follows: in favour, 33 votes, Spain, Ireland the Netherlands, Finland, Sweden and the United Kingdom; against, 29 votes, Denmark, Greece, France, Luxembourg, Austria and Portugal; with 25 votes abstaining, Belgium, Germany and Italy. Under the commitology rules, it was then necessary for the Commission to put forward a proposal to the Council for a vote on the application. The Commission put forward COM (2004) 10 at the end of January 2004. If the Council failed to come to a decision or act on the proposal within three months of having received it, it would revert back to the Commission for a decision under commitology rules.
The proposal was put on the agenda of the Agriculture Council on 26 April to allow the Council to meet its obligation to act before the end of April 2004. The Agriculture Council did not achieve a qualified majority either for or against the proposal, with most member states maintaining the position they had adopted at the Standing Committee on the Food Chain and Animal Health in December. The only changes were that Italy voted in favour, instead of abstaining, and Spain abstained instead of voting in favour. The authority for adopting the proposal now reverts to the Commission. According to Commissioner Byrne, it is now anticipated that the product will be approved during May or June of this year. The significance of this is that the granting of approval in this case will end an almost six-year de facto moratorium during which, no new GM events, be they food, feed or the deliberate release of crops, have been approved within the EU.
Ireland was represented at the Standing Committee on the Food Chain and Animal Health by the Department of Health and Children and at the Council meeting on 26 of April by the Department of Agriculture and Food. Ireland's decision to support the proposal was taken after consultation with the Food Safety Authority of Ireland and was based on the scientific risk assessment undertaken on this product, initially by the Netherlands food assessment body and subsequently by the EU Scientific Committee on Food, which concluded that Bt11 sweetcorn is as safe for human food use as conventional sweetcorn. The Food Safety Authority of Ireland is the competent authority in Ireland for the enforcement of EU legislation regarding the genetic modification of foodstuffs and carries out checks on the marketplace for compliance with GM legislation. Government policy on biotechnology is positive but precautionary, in accordance with the recommendations of the interdepartmental group on modern biotechnology, as published in October 2000.
No credible evidence has yet been provided to show that GM foods pose a risk to human health. In addition, measures to allow post-release monitoring of GM foods are provided for in the legislation. Consumer safety and consumer choice are paramount in the approach taken to GM foods. The Department of Health and Children, advised by the FSAI, is satisfied that appropriate arrangements are in place to ensure the safety of authorised GM foods, or foods containing GM ingredients, placed on the market in Ireland. The EU has one of the most rigorous regimes for the assessment of GMOs - as well as food and feed derived from GMOs. In this regard, only GM foods which satisfy the highest standards of safety are allowed on the market.
Thank you. I am sure there will be questions on this.
My main question revolves around the six year moratorium. Where did that come from? Does it cover everything or just sweetcorn? Does the Department of Health and Children know for a fact that the Commission is favourably disposed to propose this as a qualifying food? Why then did it seek a moratorium - or was it the Council of Ministers that originally sought the moratorium?
What is our role in this? I feel unqualified to make any judgment on it. If the directive, as such, has not been made, why are we scrutinising it? Are we scrutinising it prior to the Commission making a decision?
I thank the delegation for the presentation. Ms Cahalane outlined the reasons Ireland supported this decision, but did not appear to include the fact that we were lobbied heavily in the past by the United States. Is it not well documented that Sandy Berger, for example, spoke to the Taoiseach and asked him for Ireland's support on this issue? Surely that is also a big factor in all of this. A major question when it comes to GM field trials - it also applies to food - concerns indemnifying against possible risks. Ms Cahalane is saying this food is safe. Would the Government, the Commission or even the companies indemnify against that sort of risk? Surely that would be the test, especially given that they will not do so as regards field trials.
Where do we go from here? In Ms Cahalane's view, is this the thin end of the wedge, now that this is coming on to the market? Can we expect to see more foods coming on to the market? What is next?
I have some questions on the procedures that were adopted in this case. Does the Department view this proposed measure as coming within the terms of the European Union (Scrutiny) Act 2002? In other words, does the Department regard this as a notifiable measure, as defined in the Act?
Ms Cahalane correctly pointed out that this came before the Standing Committee on the Food Chain and Animal Health on 8 December 2003. Is it the case that if this committee had the requisite majority, the measure would simply have been passed and it would never have come before the scrutiny process of the Dáil?
Ms Cahalane
Yes.
The answer to that is "Yes". It is worth noting that this measure could have come, basically, before a committee of civil servants in the EU and had it been passed there, we never would have heard about it, except for after the event. However, it did not get the same majority at the Council meeting and it now falls to the Commission. Many people talk about the democratic deficit in the EU where, in effect, an unelected body makes profound decisions that affect all of Europe for the future.
I also have a more practical question with regard to labelling. I understand there will be a mandatory labelling requirement for this food, but will that also apply to derivative products? For example, if an animal such as a pig or cow is fed Bt11, when the beef or whatever is served in a restaurant or when that derivative product is sold, will the customer know that the animal has been fed genetically modified food? That adds to add my general unhappiness with this proposal.
I am more interested from a technical point of view. Can Ms Cahalane say what is the advantage of GM sweetcorn as distinct from normal sweetcorn? Are there any other GM foods available currently in this country?
Ms Cahalane
I will take some of the questions in the order they came and I will also ask my colleague, Dr. Pat O'Mahony, from the Food Safety Authority of Ireland, to deal with some of the issues. On the issue that Deputy Olivia Mitchell raised regarding the moratorium, effectively this was a de facto initiative in response to concerns raised by some member states about the need for more stringent EU legislation on GM foods. The European Commission examined the existing legislation dating back to the early and mid-1990s and considered what further laws needed to be put in place to cover traceability, labelling etc., so that when consumers were buying products they could know whether they contained GM ingredients or not. Effectively, the EU did not approve any GM food, feed or crops for sowing during this period. Therefore, the significance of the Bt11 sweetcorn is that if the Commission proceeds to approve it - as it has indicated - it would be the first approval of any GM event in six years within the EU and would, effectively, end the moratorium.
Is this food only or is it for growing purposes?
Ms Cahalane
This product is for human consumption.
Will we be able to buy it in the supermarket?
Ms Cahalane
Yes, like tinned or frozen sweetcorn. Deputy Gormley wondered if the Government would be in a position to indemnify. This has not arisen in our discussions on food but it has been raised in connection with the crops. Our colleague from the Department of Agriculture and Food, John Downey, may be able to give us some background on what is being considered in that area.
Mr. John Downey
One of our main areas is the co-existence of GM crops alongside conventional and organic crops and we are coming to that. The question of liability and compensation will come into play there, assuming that GM crops are approved for cultivation in Ireland. There is an inter departmental, inter-agency group set up within the Department which is considering several issues, including mechanisms of compensation and liability which will apply if there is a situation in which the cultivation of GM crops inflicted economic losses on neighbouring crops. It is based on a series of guidelines drawn up by the Commission in the context of co-existence of GM crops.
I was asking about the long-term effects of consuming GM foods because the Food Safety Authority is saying that this is safe. If it transpired at a later stage that it led to cancer or whatever, is the authority so confident of its findings that it can indemnify?
Ms Cahalane
: It is a good question but we base our decision on the science that is available and the advice is that this product is safe for human consumption. If any scientific advice to the contrary were to emerge, that position would change.
There are approximately 16 products on the market, mostly soya, maize and processed derivatives of those, such as oilseed rape and maize and oil from cotton seeds, most used as ingredients in processed foodstuffs. There are further approvals of GM products pending which will be put to the standing committee on the food chain and animal health, mostly also sweet corn or maize type products but also a sugar beet product.
What about the lobbying?
Mr. Corcoran
It may well be the case that the Taoiseach was lobbied on this issue but his Department was not in touch with us following that. If there was lobbying it did not feed into our process. It is in the nature of such issues that Departments are lobbied on all sides, whether for or against, but we were not aware of any lobbying from the United States on this issue.
Ms Cahalane
Deputy Mulcahy asked about derivative products. There is no requirement for derivative products to be labelled as such. The meat or milk of an animal fed with GM food does not need to be labelled as such.
Is that how we have 16 products in the country - because they are derivatives or used in the manufacturing process?
Ms Cahalane
The 16 products are those that have been approved by the European Union for use in human food.
Are those 16 products available here?
Ms Cahalane
Yes.
Are they not labelled?
Ms Cahalane
They are labelled. My colleague from the Food Safety Authority will give more details on the labelling as it is responsible for enforcing the legislation.
I am shocked to hear that derivative food is not being labelled. It is very serious.
Dr. Pat O’Mahony
The products on the market were either on it before 1997 when the novel food regulation came in or have come on subsequently but before the moratorium. They are mainly soya and maize ingredients and for the most part are in processed foods. The old labelling regulations state that if they are present as more than 1% of the total ingredients, for example in soya milk, they must be labelled. In none of our surveys have we found any above 1% so they do not require specific labelling but the operator, shopkeeper or processor would need to be able to show that he or she tried to get non-GM foods. In other words, the GM ingredient is there through contamination in storage or shipping. Our limited surveys found that only authorised foods are on the market. There are no labels for us to see because the content is below 1% which is approved by law.
Does that refer to 1% of the total content of the food?
Dr. O’Mahony
No, it is per ingredient. If there is 1% or more of the soya ingredient in a food that has perhaps four or five different ingredients as measured through the DNA content from a GM source it must be labelled "contains genetically modified soy". If there is less than 1% it does not have to be labelled specifically as such.
What is the rationale for that if there is a GM content there? Why is set at 1%?
Dr. O’Mahony
I presume the rationale came from the European Union where contamination is a problem. We do not grow soya or maize here and little is grown elsewhere in Europe. Much of it comes from North and South America where a great deal of GM soy and maize are produced. The problem is contamination through shipping or storage.
What kind of personnel are available to carry out the testing and what is the extent of it?
Dr. O’Mahony
I started to work with the authority in late 2000. We carried out the first real survey in 2001 and we used either the State laboratory, which is coming up to speed, or private laboratories. In my unit there is only myself and one other person dealing with GM foods and we deal with other——
Are there only two people testing?
Dr. O’Mahony
We do not do the testing as such.
There are only two people monitoring this.
Dr. O’Mahony
Yes.
Are there foods on the market containing GM ingredients that are unlabelled as there is no obligation in law if they contain less than 1% ?
Dr. O’Mahony
That is correct.
That is appalling.
Is this a matter for concern?
Dr. O’Mahony
It is EU law by which we are bound. They are safe as far as we can see.
I am asking if that is of concern to the authority, regardless of EU law.
Dr. O’Mahony
With the ingredients that are on the market, no. We are happy that they are safe. We do not give blanket approval. In the future if there were something we regard as unsafe we would not be happy with any level.
I had asked whether the Department regarded this as a measure which was notifiable under the EU Scrutiny Act.
Ms Cahalane
I apologise that I neglected to answer that question. Yes, we did the information note for the Oireachtas Sub-committee on EU Scrutiny on 25 February. If a qualified majority for the proposed decision was reached by the standing committee in December it would not have been necessary for the decision to come through to the Council because the Commission has the powers under regulation 258-97 to bring this product before the standing committee for approval.
The net result is that a notifiable decision, as specified under the scrutiny Act, would have been in contravention of the Act.
Ms Cahalane
I should clarify the point. We only deem it a notifiable decision because the matter was transferred to the Council for decision.
Was it not notifiable at the food safety committee?
Ms Cahalane
It is my understanding that Oireachtas scrutiny provisions currently only apply to Council, not Commission, legislation.
Correct. There is a definition included in the EU scrutiny Act. I am sorry for harping on about this. The reason I do so is decisions are being made by technical committees that could affect our lives but which do not fall within the ambit of the sub-committee on EU scrutiny.
Mr. Corcoran
The Department of Health and Children and all other Departments will comply with the requirements of Oireachtas committees in regard to scrutiny. That is not at issue. Generally, matters dealt with at Commission rather than Council level are uncontentious. The way the procedure works in practice is that if there is an anticipated difficulty, it tends not to be resolved at Commission level and is referred to the Council, as happened in this case. If, at any stage, Standing Orders or the terms of reference of Oireachtas committees are changed so as to make Commission proposals subject to the same scrutiny, any such measure will be fully complied with by all Departments.
What is the advantage of GM sweetcorn over natural sweetcorn?
Dr. O’Mahony
Any product currently on the market is not advantageous to the consumer but to the farmer. Bt 11 refers to bacteria, from which a gene has been removed, put into maize. Instead of spraying the bacteria which kill a pest on the crop, the harmful protein is in the maize. When the pest comes to eat and destroy the maize, it is destroyed.
Is Dr. O'Mahony stating there is no advantage to the consumer but to the producer?
Dr. O’Mahony
Not this one.
Is it more accurate to say it is more advantageous to big companies like Monsanto as opposed to the farmer? That is the bottom line. The vast majority of European consumers have said they are opposed to GM food, yet we, as legislators, find we are getting it regardless.
I am confused. Is the pesticide that would have been sprayed more harmful than the protein injected into the corn?
Dr. O’Mahony
It amounts to the same thing. If one has it in the corn, only those pests eating the corn get hurt but if it is sprayed, pests minding their own business and eating weeds in the next field will also get hurt.
I thank the officials for an extremely comprehensive report. Do members have any recommendations they would like to include in the EU scrutiny report on this proposal?
We would like to reject it.
Do we have the power to reject it?
We can only make a recommendation.
As I understand it, the European Commission will decide on the issue next Wednesday, 19 May. We have had an interesting discussion. I believe most consumers would be alarmed about what we have heard about derivative products. We do not even know if GM levels will be less than 1%. We are eating GM food and do not know it. Derivative products will not be labelled. We should recommend that the European Commission should not introduce it. Let us write to it before 19 May and state we do not want it.
I second that proposal.
We should seek the advice of the Department in the first instance and, if there is agreement in the committee, we should then write to the European Commission. The Department will represent the official view at Commission level. Is that agreed?
I recommend that labelling should include GM references, even if it is only 1%.
There are three proposals. Is the committee clear on them? We will recommend to the Department and the European Commission that we do not accept the proposals and that all GM foods should be labelled.
Irrespective of the risk involved.