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
125
Q 138 Back
126
See paragraphs 46-52 Back
127
Q 234 Back
128
Q 276, Ev 114 Back
129
Q 49 Back
130
Q 50 Back
131
Qq 224-225 Back
132
Q 141 Back
133
Q 265 Back
134
Ev 106-107 Back
135
Chemical Safety and Animal Testing: A Regulatory Smokescreen?
A British Union for the Abolition of Vivisection (BUAV) report
by Dr Gill Langley, March 2004 Back
136
Ev 115 Back
137
Qq 224-225 Back
138
Ev 117 Back
139
Q 2 Back
140
Q 90 Back
141
Ev 86 Back
142
Q 75 Back
143
Q 84 Back
144
Q 86 Back
145
Q 271 Back
146
House of Lords Select Committee on Animals in Scientific Procedures,
Session 2001-02, HL Paper 150-I, Appendix 3, p 64 Back
147
Q 226 Back
148
Q 229 Back
149
House of Lords Select Committee on Animals in Scientific Procedures,
Session 2001-02, HL Paper 150-I, Appendix 4, p 71 Back
150
Q 271 Back
151
HL Deb, 17 October 2003, Col 1228 Back
152
Ev 95 Back
153
Ev 113 Back