Examination of Witnesses (Questions 220
- 239)
MONDAY 9 FEBRUARY 2004
MS JUDITH
HACKITT, MR
JOHN KEMP
AND MR
CRAIG BARKER
Q220 Chairman: Who are you thinking
about? Who are these people?
Ms Hackitt: Who are people who
could conduct the study?
Q221 Chairman: Yes.
Ms Hackitt: Any of one of the
consultants that have already been involved clearly have a methodology
to offer. I think what matters is sorting out the scope of what
needs to be looked at—which is broader than what has been
done so far—and that it is done in an open and transparent
way looking at costs and benefits, I would add. I do not think
we are just looking for an impact assessment that goes into great
detail about the costs through the supply chain, we also very
much support the idea that the benefits that have been claimed
to this legislation also need to come under closer scrutiny than
they have thus far.
Q222 Chairman: Do you think environmental
constraints have slowed growth rates? Adair Turner has said this.
He says there is no evidence; do you think there is evidence?
Ms Hackitt: I do not have evidence.
I think it is all to do with whether legislation is well designed
or not. Good legislation should not harm growth rates.
Q223 Dr Iddon: Can I just press you
on this element of competitiveness? When we were in front of the
DG Enterprise last Monday in Brussels—a week ago today—he
said that since all imports of chemicals will have to play by
the same rules it should not affect competitiveness. Do you have
a comment to make on that? In other words, the chemicals imported
would have to be registered, evaluated and authorised in the same
way that any produced in Britain or Europe would have to be.
Ms Hackitt: First of all, we have
yet to see how that is going to be made to happen. I think policing
imports into Europe will be a major challenge and we have yet
to see how that would be done effectively. Even if that is done,
the question will still remain of, will that also apply to imported
goods containing chemicals? If not, then I think we would all
expect to see manufacture move out of the EU in order to avoid
some of the costs of testing.
Mr Kemp: Remember also that many
of things that we make within the EU today are not actually sold
in the EU but are exported. That is an area where manufacturing
in the UK would be subject to this legislation and we are competing
with people in other parts of the world. In my company 25% of
our EU manufacture is exported out of the EU and is not following
the same rules and having the same costs. I think the other thing
is that many chemical companies—I would characterise my
chemical company as at best a medium sized chemical company—do
operate on a global basis. So if you make it more difficult for
us to do, for example, research in the EU, a lot of companies
are just going to consider where they are going to do that research.
Why would we do it in the EU when we are supplying a global market?
Typically our customers want a product that they can market world-wide;
it matters not to us really where we do that research, we do it
wherever is the most cost effective place to do it.
Q224 Bob Spink: Animal testing. Let
us get straight to an issue that will excite massive public debate,
I suspect, as it dawns on the public what are the implications
of REACH on animal testing. First of all, whose job do you think
it is to communicate the importance of animal testing to the public?
Ms Hackitt: I think it is a shared
responsibility between industry and governments and I think what
is more important to us is the need to be honest with people about
the alternatives that are available. In the debate that has gone
on thus far one of our concerns would be that there has been some
misleading statements made about when and where you can substitute
other means for animal testing and just how readily available
and accepted those test methods are to date.
Q225 Bob Spink: Are you sorry that
the Commission, in bringing forward these REACH proposals, have
not been more up front and honest with the public about the consequences
in terms of animal testing that these proposals will have? Do
you think they have a responsibility to be more balanced and to
come up front and say that what they are proposing will mean more
animal testing?
Ms Hackitt: Yes, I do. In part
my inference about readiness and availability of other test methods
to replace or substitute for animal testing was aimed at that
very point. We do not believe—in fact we know—that
those alternative test methods have a long way to go in many cases
to being accepted as alternatives and that needs to be clear to
people.
Q226 Bob Spink: Do you think the
industry is focussing enough on developing these alternatives?
Mr Barker: I do not think it is
only industry who should do that; that is a shared task, quite
clearly. Industry has to take part in it, but also the legislators
have to work in that direction. There does not seem to be enough
emphasis on producing the alternatives to animal testing.
Mr Kemp: We do not test animals
because we want to; we test them because generally we are required
to do it to put a new product onto the market.
Q227 Bob Spink: In order to make
it safe for the public to use?
Mr Barker: Yes.
Q228 Dr Harris: We have just had
a discussion with the Science Minister in an earlier evidence
session about the issues of animal rights extremists or activists.
Is it an issue for you now—if this becomes a higher profile
matter—that your central testing facility or individual
testing facilities in UK based plants or headquarters may well
become a target? What plans do you have to deal with that?
Ms Hackitt: It is already a concern
for many of our members that this legislation has brought to the
activists' attention the amount of animal testing that this legislation
will require. In terms of what we can do about it, I think the
first thing is to make our position clear. As my colleague has
already said, we do not want to see any more animal testing done
than is absolutely necessary. For that very reason we would be
supportive of any moves proposed to minimise animal testing through
the sharing of test data, and only doing those tests that are
truly required. Again, there is a huge important role for the
Central Agency to play in this process to ensure that good, sound
decision making is taken about what testing needs to be done on
any substance rather than any member states simply doing a full
set of tests in order to cover all of the possibilities that might
be thrown at them.
Q229 Bob Spink: Craig Barker was
mentioning earlier about alternatives. Do you think there will
come a time when there are real alternatives and we can use those
alternatives rather than animal testing and still achieve the
same level of safety for the public? Or do you think in some areas
you are going to need animal testing for as long as the eye can
see?
Mr Barker: It is a balance between
those two things. I would say that there should be methodology
in determining whether there is a problem or not, then the alternative
would be to undertake the testing in animals. We have been doing
this over twenty years now in the US under their Toxic Substances
Control Act, TSCA requirements. For me that seems to function.
You call upon animal testing only when there is a concern, when
they have checked the structure of your chemistry and by putting
it through their system of checking the structure they then would
ask you to do a certain test.
Q230 Bob Spink: Do you think that
the system in the US—which is more based on real hazard
and prioritisation—works better than the system they are
trying to introduce here?
Mr Barker: I do not believe that
is the case. I think quite clearly the situation in the US is
more risk based than anywhere. They are very specific on determining
exposure scenarios, especially in the area of their toxic substance
control. On undertaking your submissions for a new substance in
the States quite clearly you have to give more information on
your exposure scenarios and how your chemistry is being used rather
than you would at present under the European scheme.
Bob Spink: You will see when you read
the transcript that you are actually agreeing with me.
Q231 Dr Turner: Clearly the amount
of animal testing that is required is going to be directly related
to the number of registrations that happen, and the proposal of
one substance one registration is suggested to be a way of reducing
the amount of animal testing. Do you think it is a workable proposition?
Do you think the Government or the Chemicals Agency or the EU
Commission have any role in facilitating the formation of consortia
for carrying out testing and determining the cost of it?
Ms Hackitt: Yes, we do. Let me
take your earlier point first, do we think one substance one registration
is a workable proposition? Not as an absolute rule, no we do not.
We do believe that as a principle that should guide what we try
to do in terms of sharing data wherever possible, encouraging
people to come together and share data, share costs and most certainly
to share data on animal testing to avoid any duplication, those
elements of the principle of one substance one registration we
fully support.
Q232 Dr Turner: One other caveat
has been put to us which is that as well as looking at the substance
we should look at the process by which a substance is produced
because different processes may produce a different range of trance
contaminates which may themselves be toxic. Do you have any view
on that?
Mr Barker: It is not so much the
process, it is more the end point, the substance as a whole you
have to deal with. Yes, I think you do, to a certain extent, you
have to look at the product as its whole, including its impurities
and by-products. However, using trained toxicologists quite clearly
you can bring those analogous substances together. We should make
full use of that opportunity.
Q233 Dr Turner: Are you worried about
companies who have not contributed to any of the work that is
involved in registration coming in and freeloading and getting
the benefit of work that has been done at the expense of other
companies in business?
Ms Hackitt: Of course that would
be a concern and I think again that comes back to your earlier
point about is there a role for the Commission to play in encouraging—and
in some cases mandating—people to come together and to co-operate
in putting substances through this process. We feel there is a
very important role to be played in ensuring that those things
happen.
Q234 Dr Turner: The Competition Commissioner
told us in Brussels that sharing the animal data is obligatory
under the current proposals. Is that your understanding of it
and do you see this as being enforceable?
Ms Hackitt: Yes.
Mr Kemp: I would say that I support
it and also that it should be enforceable. I do not see any issue
with that. I think our issue with one substance one registration
does not come from that. There are two parts of registration:
one is generation of the physico-chemical data and the data from
animal testing. That is the piece that we think we should be absolutely
maximising all co-operation, getting people working together.
The other part is about end uses and the risks associated with
end uses. We feel very clearly that when you can have the same
chemical with very different end uses, trying to put all that
together in one risk assessment will just slow down the whole
process and make the whole thing unworkable. If you co-operate
on the piece that you can co-operate on—which is the generation
of data—then each of you who have different uses for a substance
then go and do your risk assessment in terms of end use et
cetera—which in many cases is also fairly confidential
information which we would be loathed to share with others—I
think you can get the best of both worlds.
Q235 Dr Iddon: You seem to have a
problem with the registration phase. You are arguing for registration
of all substances at the same time whereas as I understand it
the present proposal is registration by tonnage of production
in three different levels. Can you say exactly what your objection
is to the registration proposal?
Ms Hackitt: I apologise if I give
the impression that I am arguing for everything to be registered
all at once. Far from it. I think if we are going to have a workable
system there has to be an orderly queuing process. At the moment
that orderly queuing process is envisaged based upon volume. My
argument—and the industry's argument—is that volume
may well not be the best way or the single way of conducting that
and we believe that a pre-registration prioritisation process
to decide which substances of concern should be assessed first
would serve everyone better.
Q236 Dr Iddon: Who determines the
prioritisation? Which chemicals are of the most concern, who makes
the final decision on that?
Ms Hackitt: I think that is a
decision which should involve consumers, retailers; it certainly
should not be a matter for the chemical industry to decide in
isolation. It should be one that involves all stakeholders.
Q237 Mr McWalter: Would you clarify
something for me, please? Common salt, NaCL is clearly a chemical,
it is clearly produced in quantities above a thousand tonnes and
so on, so potentially it would be something to be tested. We know
it is toxic, of course. Could you produce a dossier which says
that this substance has been used for thousands of years and your
dossier could be a one line long? In other words, see if there
is a way of meeting the criteria without having a massive amount
of stuff to be put into an analysis of that sort. Or is it assumed
that there is going to a huge great series of dossiers about common
salt?
Ms Hackitt: Potentially there
could be, is the answer. We would prefer to go towards your earlier
description of a proportionate and pragmatic system that takes
account of common sense and what data we have and know about.
Q238 Mr McWalter: Would you do a
trial of a one line dossier of commonly accepted substances even
though they have a demonstrated toxic capacity?
Mr Barker: You would not even
need that. In many cases most of these chemicals have already
gone through several evaluations over their lifespan. We have
had the existing chemicals legislation; we have had the HPV programmes
running in the States and under the OECD initiatives. These have
all gone through these types of chemicals and we are not using
those to the best advantage of this legislation; they have just
been ignored.
Q239 Dr Iddon: We were told on Monday
at the Commission that natural products are not included in this
legislation and I would regard sodium chloride as an absolutely
natural product since it occurs in the sea. I think they are going
to have trouble by excluding natural products because what is
a natural product? Can I take the evaluation stage next? When
you talk to commissioners and to the green NGOs they give you
the impression that industry is sat on loads of basic toxicity
data and it has never been published—possibly for competition
reasons, possibly for reasons of formulation of products—and
the evaluation stage of REACH is going to be made much easier
if industry comes up with all this stuff and banks it with the
Agency in Helsinki or wherever it is going to be based. Can you
comment on that suggestion?
Mr Kemp: Industry has shown itself
very willing and capable under the current US, EPA, HPV programme
to put all its information on the table and share it. The thing
that you get is that the requirements under this legislation go
much further than anything else. I am sure you will know that,
depending on tonnage, there are four different annexes which specify
the amount of testing that you need to do. The stuff that has
been done for the most advanced programmes today only goes through
annex five and six and a little into annex seven. Annex seven
and annex eight are the one where we really start spending money
and really get involved in a lot of animal testing unless we get
this pragmatic approach for evaluation. In fact, one of the biggest
things which is going to determine the level of animal testing
is the pragmatism which the member state authorities show in terms
of approving the testing plans that you have to propose as part
of this legislation. The easiest thing for them to do—and
frankly what many of them have done in the past—is just
to say that as we can demand all this testing, we will have it
all. Having all that testing of a substance over a thousand tonnes
(the annex eight material) which, in the chemical industry is
nothing—a thousand tonnes is a very small volume material—if
they demand everything we are talking about a cost of a million
pounds per substance and we are talking about, in round terms,
a thousand animals being tested.
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