Select Committee on Science and Technology Minutes of Evidence


Examination of Witnesses (Questions 260 - 279)

MONDAY 9 FEBRUARY 2004

RT HON ALUN MICHAEL MP, DR COLIN CHURCH, MS GIULIA MUSTO AND MR PATRICK WALSH

  Q260  Chairman: The impact assessment that you are carrying out, is there anything that you are going to learn or any questions that you are asking that were not asked by these other smart Europeans?

  Dr Church: One significant difference will be that the European Commission's impact assessment looked at the Europe-wide effects and it is clearly the case that the chemical industry and other industries are differently structured in different member states, so it is entirely possible that we expect to find that there would be a different kind of impact within the UK than, say, Germany or France or one of the other bigger chemical producers. That is one reason. Another perhaps less honourable reason is that we have to; as I mentioned earlier it is a requirement for us. Also, thirdly, because what we want to try to do, wherever we can, is to get an idea of the different costs and benefits of different potential approaches. As this Committee has already heard we think there is a lot to commend the idea of one substance one registration. We have some idea of the benefits of that approach but we need to work out in more detail some of the other possibilities that are around in terms of what the testing package might contain, what you might do to look at articles, for example, and other issues like that. As much as we can do in our impact assessment to understand those issues will be helpful in not only ours but others' negotiations further down the track.

  Alun Michael: There are a number of other states which are also taking their individual impact assessments; I think Sweden and Ireland are also. Obviously that all feeds into the pot of improving our knowledge.

  Q261  Dr Iddon: In terms of cost to the European chemicals industry, the impact assessment has been as high as £12 billion and sunk to £2 billion over 11 years, but when we met the representative from CEFIC in Brussels last Monday his main criticism of the impact assessment of the European Union was that it had not looked at the whole supply chain. Is your impact assessment going to take that into consideration?

  Dr Church: We are not going to produce one answer at the end of the current work we are doing because it is too complex an area. What we will see shortly is a partial RIA that does what we can, that invites comments on the methodology and then that starts the next phase. In that next phase we are precisely trying to look at either a chemical through a supply chain or a particular sector to get a feel for this kind of issue, the wider economic impact. That is potentially a source of some great impact and great uncertainty. This area is underpinned by a great uncertainty about numbers.

  Q262  Dr Iddon: Is it possible to do—within the limits that you are looking at—a fairly accurate impact assessment in this area?

  Dr Church: I think it is not possible to do an absolute level that is perfect in that sense because you have too many underlying uncertainties. You will have heard many people talk about the 30,000 chemicals on the market above one tonne; that is an estimate, a guess, based on expert knowledge. You will have heard people talk about there perhaps being three companies producing each one of those chemicals; that is another guess. Some of the chemicals that we have dealt with, there are as many as fifty separate producers, sometimes just two in the EU. Therefore there is a massive range of uncertainty. Any figures you come up with are underpinned by a series of assumptions and one has to be clear about what those assumptions are.

  Alun Michael: The point at the heart of that is that you do not assume that this is something that is simple and on which absolute answers are easy to come by. The importance of protecting human health and the environment leads most people to say that we do need something which deals with these issues and the question is to get the balance right, not to jump ahead of knowledge, but to make sure that we are as close to getting it right as we can be. If the point of your question is to suggest that this is not an exact science, that it is one where we are moving from a position of fairly low knowledge to one of greater knowledge, then I would absolutely agree with you.

  Q263  Dr Iddon: My concern is that we do not underestimate the possible damage to the industry throughout Europe.

  Alun Michael: I think we want to make sure that we do not either underestimate it or overestimate it. I think there were original estimates which suggested there would be horrific impacts on industry. I think what we are getting to now—because of the amount of discussion that is going on—is a more realistic assessment of the impact on industry and therefore a balancing of the cost and benefits. That must be the right way to approach it.

  Q264  Bob Spink: Could you tell me, Minister, what the Government is doing to tell the public that this policy will involve the testing of hundreds of thousands more animals?

  Alun Michael: I think one of the things that we are keen to see—again this was a matter of discussion with NGOs and the industry—is to find something which involves chemical testing which is appropriate and necessary in order to get the answers to questions that need to be asked but to avoid duplication. That is one of the reasons why the one substance one registration . . .

  Q265  Bob Spink: Sorry, Minister, I am not following you at all. I asked what the Government has done to tell the public that this policy involves the testing of hundreds of thousands more animals. Have you just said nothing?

  Alun Michael: You put it in a confrontational way and I was trying to explain the way that we are approaching it which is that we believe that animal testing is appropriate where it is necessary in order to be able to provide evidence that is needed.

  Q266  Bob Spink: I will come on to the appropriateness of it and alternatives in a moment, but what have you done to tell the public so far? Anything or nothing?

  Alun Michael: What we have tried to do is to give a proper assessment of what the implications of REACH are in terms of animal testing, in terms of certainty and to work with the non-governmental organisations to make sure that REACH does not involve unnecessary and disproportionate testing. That is why I was making the point about one substance one registration because if you allow multiple registration—if there are not alternative methods of undertaking tests and giving certainty about the impact on health—then you would increase the amount of testing that is necessary. If you avoid that then we are actually not increasing but minimising the testing. We have included estimates of annual numbers in the RIA for the White Paper. We published a position statement so that information is there as part of our assessment of what is involved with REACH.

  Q267  Bob Spink: We have been told by the industry that there would be round about a thousand animals tested per substance. There may be 30,000 substances above a tonne, as you have just said yourselves. That is an awful lot of animals. We will not be testing all of the animals or all the substances. If we said that it was just 1,500 substances then that would be one and a half million additional animals tested. Do you deny these figures?

  Alun Michael: I think they are based on a number of assumptions and the question is, are there adequate alternatives to animal testing? If there are then we would be keen to see those used so that we keep animal testing to a minimum. The purpose of animal testing must be the protection of human health, not just for it to be done for reasons of fitting with the arithmetic.

  Q268  Bob Spink: What are DEFRA doing then to fund new, non-animal alternative approaches to toxicity testing? What funding is DEFRA giving to that at the moment?

  Dr Church: The first question about the number of a thousand animals per substance was, as I understood, what the gentleman from the CIA said for a substance that undergoes the full set of testing through to annex eight, so it is only the top level of chemicals.

  Q269  Bob Spink: How many would that be? How many chemicals?

  Dr Church: The latest estimate that I have seen is about 2,000 chemicals.

  Q270  Bob Spink: So that would be two million animals.

  Dr Church: However, we do not think that a straight box-ticking testing regime makes sense and that is not what we are arguing for. We would not accept that that is the kind of level of animal testing that should result.

  Q271  Bob Spink: What number would you put on it?

  Dr Church: That is a very difficult question to answer. You made the point in your questioning earlier to the CIA about how much information is available in industry. If you look at the US HPV programme (that is high production volume, the chemicals we are talking about) their experience there is as little as 6 to 10% of data is new, the rest of it is already somewhere in the system. If those figures hold true for the US and for the EU—and we have no reason to say not—then again you are taking 10% of those numbers rather than 100% of those numbers.

  Alun Michael: Can I also go back to the issue of the findings of the House of Lords select committee on animals in scientific procedures. There has been work going on across government to look into the scope of setting up a UK centre and the development of proposals on how that might function. Those are due to be considered by the Home Office and the DTI in February, so later this month. The current budget for research into alternatives to animal testing in the UK lies with the Home Office and is £280,000 but other research in this area is carried out within the industry. The amount of funding committed is not easy to quantify so the question being specific to DEFRA, the animal testing element lies primarily with the Home Office. We also support the work of the European Centre for the Validation of Alternative Methods which has a research budget for 2003-06 of

35.2 million.

  Q272  Bob Spink: In summary then, Minister, what you have answered to my final question on funding for animal alternatives is that DEFRA are not giving any funding at all to this; it is the Home Office's responsibility and they are giving £280,000 where the costs per product—and we are looking at perhaps 30,000 substances—would be well in excess of £1 million per product. So this is not even a pinch, is it?

  Alun Michael: I am sorry; I think you are putting a considerable amount of spin on the answers. What I said was not that DEFRA is not contributing, but actually the responsibility lies with the Home Office and not with DEFRA which is the reason for pointing out the contribution that the Home Office puts in. I also pointed out the work of the European Centre which is at the level of

35.2 million and which obviously is significant to consideration of the way in which testing is used as an alternative to animal testing as the REACH proposals are developed further.

  Q273  Bob Spink: Now I am confused again. Is DEFRA actually giving some money then or not?

  Alun Michael: I made it clear that the responsibility lies with the Home Office. But you could also ask the question as to whether the Scottish Office or the man in the moon is making a contribution.

  Q274  Dr Harris: You have been asked whether you are taking it upon yourselves to inform the public that there may be a significant increase in animal experimentation and then there was a discussion about big that would be. I want to get into that. I understood what you were saying and I understand your motives and the efforts you are putting in to reduce the numbers. However, on the assumption that there will be an increase—even if it is a small one—are you prepared, as a minister, to put your head above the parapet from DEFRA and say that there will be an increase in animal testing but it is worth doing for the purposes of both animal health—so far as the WWF are concerned—and human health, for the purpose of these chemicals? Or are you going to leave that to Lord Sainsbury to say?

  Alun Michael: I think both of us are saying the same thing, actually, which is that testing which is effective in improving the protection of human health—not only in this country but across Europe—is something that is supported, but we would wish to keep that to the minimum.

  Q275  Dr Harris: If it becomes clear that there is going to be an increase, despite the best efforts—and I have no doubt about your best intentions here, indeed everyone's best intentions—that we will be able in a year or two's time to find speeches by you (if you are still in post) and your colleagues and successors that say yes, it is something that has to be done?

  Alun Michael: Yes. If we can put hand on heart and say that it has to be done because without this we could not achieve the level of protection of human health, then yes. However, I think at the design stage of the proposals one can ask questions and again going back to the point about one substance one registration . . .

  Q276  Dr Harris: This is what I wanted to raise with you. You said in your memorandum that one of the main advantages—in fact it is the first one you list in your memorandum—is that one substance one registration will minimise animal testing through the sharing of data in consortia. In your conclusions you say: "In particular, we believe that a system of one substance one registration would" dot, dot, dot "lead to a reduction in animal testing". However, Commissioner Liikanen told us very clearly that sharing the animal testing data is obligatory regardless of one substance one registration. Can you put those two together?

  Alun Michael: The Commission has certainly moved in the direction we have been pressing for and their most recent proposals do press for that exchange of information. We feel that it is possible to go further along the one substance one registration road. What we are saying is that the regulation is not right yet. They are moving in the direction in which we believe they ought to go; we do not think tight enough and we believe that during the remainder of the period, as the regulations develop, we can go further on that.

  Dr Church: Would it be helpful if we gave a couple of examples where we think it is not obligatory yet?

  Q277  Dr Harris: No, because I want to explore the hypothetical. He said it is going to be obligatory. You might not think that he has got there yet, but in those circumstances, do you accept that you cannot use reduction in animal testing as one of the reasons—I know you have others—for promoting one substance one registration?

  Alun Michael: If that requirement is absolute—which obviously goes further than the October text so it would need to be reflected in a development of the text—then that will go a considerable way to reducing the increase of animal testing that would result from REACH. We have not seen that reflected in a fresh text as yet.

  Q278  Dr Harris: I would like to have those examples, but not necessarily now. Could you write to us on them?

  Dr Church: I would be happy to do that.

  Q279  Dr Harris: If you were satisfied that those textual changes were made then you would not necessarily have to insist on one substance one registration because the main reason for doing so has been met. You could claim victory, in fact.

  Alun Michael: I think given an invitation to claim victory, who would I be to refuse it? I think there are other advantages with the one substance one registration. One of them is consistency that one registration based on one set of evidence and applying across Europe has advantages. I think consistency across Europe is a good thing for our industry. You are right in saying that one of the big imperatives for this country's approach to one substance one registration has been the minimisation of animal testing and we have recognised from the beginning that there would be an increase. What would be challenging about it is the extent of any increase which, as I think I indicated earlier, can easily be extrapolated. The point is that consistency in the way the system is developed in order to protect human health and the environment consistently is something that we would like to urge as well.


 
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