House of Commons - Science and Technology

Select Committee on Science and Technology Sixth Report

6 TESTING REQUIREMENTS

84. An important element of REACH is that substances introduced before 1981 should be subject to more rigorous testing and that what data there are should be in the public domain. This will impose a cost burden on industry but the main area of contention is the number of animal tests that will be conducted in ensuring compliance with REACH. The requirements are set out in detail in the annexes to the Proposals. The information requirements for testing are set out in Annexes V-VIII. Annex V consists of mainly non-animal physicochemical tests, with the requirements in subsequent annexes being progressively increased with volume. Annex IX contains rules for adapting the standard testing requirements.

Annex V: requirements for substances manufactured or imported in quantities of 1 tonne or more.
Annex VI: additional requirements for substances manufactured or imported in quantities of 10 tonnes or more.
Annex VII: additional requirements for substances manufactured or imported in quantities of 100 tonnes or more.
Annex VIII: additional requirements for substances manufactured or imported in quantities of 1,000 tonnes or more.

Animal tests

85. This inquiry has considered the Commission's Proposals for chemicals legislation and we have not sought to form a collective view on the ethics of animal testing. There are, however, a number of issues relating to animal testing that we wish to address.

NUMBER OF ANIMALS

86. It has been generally concluded that the Proposals will lead to an increase in the amount of animal testing, at least in the short term, since many existing chemicals will not have been tested on animals to the standards required by the Proposals.[117] Animal testing is expensive and therefore demands for its minimisation are not restricted to the animal welfare groups. Leigh's Paints' evidence states that even with the provision for data sharing, there will need to be a massive increase in testing overall and a significant increase in animal testing.[118] Estimates of how many extra animals will be used are hard to come by, however. The Biosciences Federation (BSF) submission says that in 2002, 162,000 animals were used by industry for safety testing (6% of the 2.73 million total used in scientific procedures).[119] The BSF concludes that a "substantial portion" of the 30,000 chemicals expected to go through the Registration process will need further testing. It concludes that, on average, an extra 80,000 animals will be required each year in the UK alone.[120] The UK has 13.5% of the EU chemical industry, which suggests that around 500,000 animals would be required across the EU each year and thus 5.4 million for the duration of the 11-year phase-in period.

87. Following the publication of the White Paper in 2001, the then Department for the Environment, Transport and the Regions commissioned the Institute for Environment and Health at Leicester University "to inform policy development in relation to proposals in the European Commission White Paper". The authors calculated a worst-case scenario, based on OECD requirements, that if testing were required for the full 30,000 chemicals then between 2.5 and 3.9 million mammals and fish would be needed.[121] The Government seems to be unable or unwilling to publish a more up to date estimate. In giving evidence, Dr Colin Church told us "that is a very difficult question to answer". He told us that approximately 2,000 chemicals would need the testing required by Annex VIII.[122] John Kemp from Infineum International Limited told us that each Annex VIII chemical (produced in volumes of over 1,000 tonnes per manufacturer/importer per year) would require 1,000 animals. On this basis, we can calculate that, assuming no data exist already, around 2 million extra animals will need to be tested for chemicals coming under Annex VIII as a result of REACH, across the EU.

88. In a written answer to Bob Spink MP, Mr Michael gave a partial answer. He said that there are likely to be 20,000 chemicals being produced or imported in quantities of less than 10 tonnes (Annex V). For this volume, the Commission requires 25 animals per chemical. Assuming again no duplication of testing, we arrive at a figure of 500,000.[123] This leaves approximately 8,000 chemicals produced in quantities between 10 tonnes and 1000 tonnes (covered in Annexes VI and VII). Dr Church estimated that 90% of the data already existed but it seems likely that less data exist for the later Annexes, given the more stringent requirements.

89. It is a pity that our rather crude estimates have not been supplemented with a more in-depth analysis by the Government and the Commission, since increased animal testing is a controversial and unfortunate by-product of the legislation. It is surprising that BUAV has not even attempted a calculation and states in its evidence merely that "the overall requirement is for data obtained through many millions of animal tests".[124] DG Environment is even less helpful. Dr Delbeke told us that the REACH Proposals would increase animal testing but "only marginally" due to the application of QSARs (quantitative structure activity relationships).[125] We recommend that the Commission provide estimates of the number of animals likely to be used for testing as a result of the REACH Proposals and make clear statements that these animals' lives can be justified by the improvements to the environment and human health achieved by the new legislation.

ONE SUBSTANCE-ONE REGISTRATION

90. We have discussed the merits of one substance-one Registration above.[126] The first advantage, according to the Government, is the minimisation of animal testing. This is a noble aim so we asked the views of Commissioner Liikanen. His response was that the sharing of animal testing data was already compulsory, which also seems to be the understanding of the CIA.[127] Officials at DEFRA know better and, following our evidence session, we have been supplied with some scenarios in which data may not be shared:[128]

b) If no test data exist then registrants who need the data "shall take all reasonable steps to reach agreement as to who is to carry it out on behalf of the other participants". If no agreement can be reached then duplicate testing will occur.

c) If a substance is produced both at high and low volumes, it is possible that if the latter manufacturer/importer has relevant data that is not available through the Substance Information Exchange Forum at the time of pre-Registration/Registration the former may conduct further tests.

d) For non-phase-in substances, if cost sharing cannot be agreed between registrants, the Agency, on request, will hand over study summaries for all the tests needed by the subsequent registrant, leaving open the possibility that the subsequent registrant will repeat the test. Also, only the study summary will be provided, and this may not be sufficient if the registrant wishes to use the data in another context, which could lead to repeat testing.

91. If we assume that DEFRA is correct, this raises the questions over the number of animals which are likely to be spared and the likely cost of achieving this as a result of mandatory consortia formation. We are concerned that the answer to the former is not many and the answer to the latter is quite a lot. The Government has identified scenarios where there could be duplicate animal testing if one substance-one Registration is not imposed. While we sympathise with the desire to minimise testing, the response must be proportionate and that covering every eventuality could impose an unjustified burden on industry.

92. Most of the evidence we received expresses the view that animal testing should be reduced as far as possible, but without any clear articulation of the acceptance that the increased use of animal tests will improve human health and the environment. Mark Strutt from Greenpeace told us that "Most of our supporters would accept the need for some animal testing on many premises, not least because animals too in the wild are exposed to and affected by the type of chemicals".[129] Andrew Lee of WWF said "You talked about REACH driving up the number of tests but that is only because a proper testing regime is being put in. The reason the numbers are low at the moment is that most of these chemicals are not properly tested at all, and surely that is not acceptable".[130] Judith Hackitt of the CIA said that communicating the need to use animal tests was a shared role between industry and governments but that the Commission should have been doing more to articulate this.[131] Dr Delbeke argued that the Commission had been making these points clearly.[132] This is not our impression and we sense a reluctance on that part of the Commission to be fully frank about the extent of animal testing required by REACH. The Minister, Alun Michael, told us that "animal testing is appropriate where it is necessary in order to be able to provide evidence that is needed". This case needs to be made more strongly and more often.[133]. The Government, the chemical industry, the Commission and the environmental NGOs need to say clearly and publicly that a large number of extra animals will be used and killed in testing, but that this is worth it to achieve the environmental and health benefits intended by the legislation, which aims to benefit animals too.

Non-animal tests

93. A major element of BUAV's argument is that animal testing does not give reliable information on which to base measures to protect human health.[134] It gives 10 reasons for this conclusion:[135]

ii. The absorption, distribution, metabolism or excretion of a chemical differ between species;

iii. The tissue effects are not the same at the macroscopic or microscopic level as in humans or are seen in different organs;

iv. Differences at the anatomical, physiological, cellular, subcellular or receptor levels cause varying susceptibilities to toxicity;

v. The dose required to produce toxic effects in animals may never be reached in humans;

vi. The target dose in humans cannot be achieved in test animals or the test is not sensitive enough;

vii. The potential synergy between many chemicals to which humans are exposed cannot be studied in animal tests;

viii. The test animals (i.e. inbred, genetically identical rodents) neither represent normal animals of their species nor the human population of concern;

ix. The experimental conditions may differ from test to test; and

x. The experimental conditions are inappropriate to the human situation.

94. Europeans for Medical Advancement (EMA) also believes that many animal tests do not provide useful data. This group argues, for example, that 80% of cancers have an environmental cause and that environmental chemicals are a likely cause. It cites research by the US National Cancer Institute, which tested 12 anti-cancer drugs on mice that are currently being used successfully in humans. The scientists took mice that were growing 48 different kinds of human cancers and treated them with the 12 drugs. They found in two thirds of cases the drugs were ineffective in the mice and thus inaccurately predicted human response.[136] EMA argues that alternatives could provide at least as good an indication of the toxicity of chemicals to humans. It further believes that the REACH legislation would be better delayed by several years than passed with the existing set of animal tests.

95. The CIA does not feel that animal tests could be replaced yet. Judith Hackitt told us that "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 … 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."[137]

96. The EMA evidence asserts that, in private, environmental NGOs agree with the arguments it is making, yet refuse to back the position publicly. Dr Ray Greek from EMA tells us that:[138]

"We have spoken with numerous environmental groups who agree with us that the current REACH concept of using animals to test for effects of chemicals on the environment is misguided. The idea that testing chemicals on three or four species and obtaining from this, informative data for what the chemical will do to other species and the environment as a whole is specious. The green groups realise this but do not wish to bring this position to bear lest they lose what political influence they think they have achieved with this campaign."

In giving evidence to us, Andrew Lee told us that "WWF is in favour of substituting for animal tests wherever there are technologies and techniques available that can provide the data we need. But … we do not believe it is possible to provide the data to end the use of some of these chemicals of very high concern … without some animal testing data".[139]

97. Dr Greek argues that "to sacrifice principle, and in this case, in all likelihood, human and animal lives in order not to be perceived as being too radical is disingenuous at best and immoral at worst". This is a serious allegation, suggesting that the green NGOs are more interested in a political victory than protecting the environment. The tests are the foundation of the legislation; unless they have some validity, it becomes a pointless, bureaucratic exercise. As Emily McIvor told us, "I do not have very much faith that the REACH proposal… including the battery of tests, can do very much good at all in terms of improving chemicals regulation".[140] The validity of the tests required by REACH is fundamental to its ability to protect the health and environment from toxic chemicals. If any party has any doubts about the application of the tests required by REACH, then we consider it to be dishonest to continue promoting the legislation until these doubts have been resolved or better tests introduced.

Development of new tests

98. The Royal Society of Chemistry describes the problems associated with new tests being incorporated into chemical regulation:[141]

"New test methods will take time to develop, validate and gain acceptability by regulators. … In general companies prefer to use test methods that don't involve animals. However a company cannot use alternative tests until legislators and regulatory agencies have confirmed that they will accept the results. In the past it has taken many years of international validation studies before legislators and regulatory agencies would accept the results from alternative test methods."

Mike Barry from Marks and Spencer also feels that the introduction of alternatives has been too slow: "insufficient effort was put in ten years ago to start the programmes that we need now, so we are where we are. We would like to see the chemical agency and other bodies in Europe really driving forward a plan to look for alternatives".[142] Emily McIvor from BUAV told us that animal testing continued simply because it has always been done.[143] Dr Langley told us that she would not claim that all the non-animal tests are available but that there were enough "to allow substance prioritisation for substances, to allow regulation and better regulatory decisions to be made in the short term".[144]

99. One problem is the setting of appropriate standards. The European Centre for the Validation of Alternative Methods (ECVAM), part of the Commission's Joint Research Centre, is responsible for coordinating the independent evaluation of the relevance and reliability of tests for specific purposes, so that chemicals and products of various kinds, can be manufactured, transported and used more economically and more safely, while the current reliance on animal test procedures is progressively reduced. It has an annual budget of €35.2 million.[145] The EMA points out that none of the current animal tests has been subject to the demands being made for alternative methods. To retrospectively validate animal tests would be expensive and would in itself involve the extensive use of animals.[146]

100. Craig Barker of Ciba Specialty Chemicals told us that industry had a part to play in developing non-animal tests but that the legislators have to work in that direction too: "There does not seem to be enough emphasis on producing the alternatives to animal testing".[147] He told us that the US Toxic Substances Control Act requires alternatives to be used to identify if there is potential problem. Animal testing is only employed when alternative tests raise concerns about the substance.[148]

101. The House of Lords Select Committee on Animal Procedures reported that a 20% reduction in animal tests could be achieved through the harmonisation of test guidelines, reductions in the number of animals used in each test, and greater use of available alternative methods. A 50% reduction would require considerably more development and scientific research but was feasible within 10 years. A 90% reduction would probably take at least 20 years, and would need a major breakthrough in mathematical modelling and molecular biological techniques. The Report stated that,at the EU level, research funded by DG Research has not led to the development of any new tests.[149]

102. Annex IX sets out alternative methods of testing to those set out in Annexes V-VIII. This includes in-vitro methods and states that "Results obtained from suitable [according to internationally agreed test development criteria] in vitro methods may indicate the presence of a certain dangerous property". These tests can only be used, however, to prove the existence of a hazardous property, and a negative result requires that the standard tests are performed. ECVAM has a considerable budget; if it has been making progress there is little to show for it in the REACH Proposals.

103. We believe that the current rate of progress in developing and validating non-animal tests is too slow and that the European Chemical Agency must play a role in driving forward change. It is unlikely that animal tests can be replaced in the Regulation before it comes into effect but we believe that there should be a framework and a timetable for change embedded in the legislation. It will be several years before much of the test data is required. This provides a window of opportunity that should not be missed.

104. It is of concern to us that, first, non-animal tests should be developed and, second, the process for validation and adoption in legislation is rapid. The current UK budget for alternatives is small but progress needs to be made at a European level if it is to have an impact on chemicals legislation. The Government should play a bigger role in making sure that alternatives, where available, are incorporated into European legislation. Current research expenditure by the Government on alternatives is £280,000, from the Home Office.[150] The Lords Committee recommended that a national centre to promote alternative methods should be set up and Lord Sainsbury, Minister for Science and Innovation, announced on 17 October 2003 that the Government agreed with "the persuasive case put forward by the Select Committee".[151] Mr Michael made it clear that funding for research into animal procedures was within the remit of the Home Office, which is entirely appropriate given that it is responsible for its regulation. Just as Lord Sainsbury, as Science Minister, has taken an interest in research into alternative, non-animal tests, the Minister of State for Rural Affairs and Local Environmental Quality should use his influence to ensure that this research funding is directed towards new and sensitive environmental toxicology tests.

QSARS

105. Results obtained from quantitative structure-activity relationship models (QSARs) may indicate the presence or absence of a certain dangerous property. The Commission has set out when the results of QSARs may be used. Article 11 says the development of approaches such as QSARs shall be taken into account in any proposals to modify the information requirements for 1 to 10 tonne registrations. The CBI welcomes the provisions for QSARs but argues that their use should be extended beyond substances produced below the 10 tonne threshold.[152] The Government is seeking responses to this question as part of its consultation.

Testing capacity

106. Concerns have been expressed about the practicality of testing 30,000 chemicals within 11 years. The Crop Protection Association points out that evaluation work frequently takes longer than expected.[153]

117 Ev 58 Back

118 Ev 56 Back

119 Ev 59 Back

120 Ev 59 Back

121 Institute for Environment and Health (2001) Testing Requirements for Proposals under the EC White Paper 'Strategy for a Future Chemicals Policy': an update Back

122 Q 271 Back

123 HC Deb, 3 March 2004, Col 928W Back

124 Ev 106 Back