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Michael Balls

Publications and source records attributed to Michael Balls.

At least 37 records · Page 2Linked to original sources
PubMed2005

The use of non-human primates in regulatory toxicology: comments submitted by FRAME to the Home Office.

The Home Office have circulated a document that summarises the discussions of a Primate Stakeholders Forum. The Forum took place in January 2004, and was convened to address the issues raised and the recommendations made in the Animal Procedures Committee 2002 report on the use of primates under the Animals (Scientific Procedures) Act 1986. The report emphasises the need for more resources focused on alternatives to toxicological testing in primates, including harmonising worldwide regulatory requirements, investigating the relevance of primate models, and improving the retrospective analysis of procedures involving primates. The document called for reasoned comments about the report to be submitted to the Home Office. In response, FRAME submitted a comprehensive paper, which evaluated each of the Animal Procedures Committees recommendations, along with the Home Office Forums comments. FRAME believes that, in coming to a decision as to whether primates should be used for regulatory testing, there must be full consideration of all the information available, including whether the ethological needs of any given species can be met prior to, during and following experimental use. Where these needs cannot be met, there must be a concerted effort to develop alternative models for research and testing. However, this should not detract from the ultimate goal of phasing out primate research altogether.

Animal Experimentation↗
PubMed2005

[The three Rs: looking back ... and forward].

Personal experiences at FRAME and ECVAM are recalled, alongside the evolutionary progress of the Three Rs (replacement, reduction, refinement,) approach to animal experimentation, described in great decades analogous to the Great Ages of Western Civilisation.

Animal Rights↗
PubMed2004

Progressing toward the reduction, refinement and replacement of laboratory animal procedures: thoughts on some encounters with Dr Iain Purchase.

A variety of encounters with Dr Iain Purchase over the last 25 years are reviewed in relation to their significance in terms of progress toward the reduction, refinement and replacement of animal procedures in toxicology and toxicity testing. Included are the work of the first FRAME Toxicity Committee and the FRAME International Alternatives Validation Scheme, the International Conferences on Practical In Vitro Toxicology and the foundation of Toxicology in Vitro, the work of an Institute of Medical Ethics working party on issues raised by animal experimentation and alternative approaches, the need for in vitro assays for chemical carcinogenesis based on the transformation of human cells, the problem presented by the human hazard potential of thousands of chemicals already in use before modern regulations for the registration of new chemicals came into force, and the importance of testing strategies with a focus on the integrated use of non-animal computer-based and in vitro test systems.

Animal Experimentation↗
PubMed2004

A scientific and animal welfare assessment of the OECD Health Effects Test Guidelines for the safety testing of chemicals under the European Union REACH system.

We have assessed each of the OECD Health Effects Test Guidelines (TGs) that were included in an annex to the Internet consultation issued by the European Commission relating to the Registration, Evaluation and Authorisation of Chemicals (REACH) legislation for the testing of new and existing chemical substances. Each guideline has been analysed with respect to its design and its scientific and animal welfare implications, the extent to which it makes use of modern techniques, and its suitability to be used in the REACH system for the testing of large numbers of chemicals. The scientific basis of the test and its justification are considered, as well as the numbers of animals required, and the potential adverse effects on them. The prospects and possibilities for applying the Three Rs (reduction, refinement and replacement) to each of the TGs are also discussed. We have proposed an overall testing strategy for how these TGs and other methods could best be deployed for chemicals testing, should it be necessary to fill data gaps. Certain TGs have been omitted from the strategy, when we have considered them to be unnecessary for chemicals testing. A series of recommendations has been made for improving the TGs with regard to both their scientific content and ways in which they could be better designed in relation to optimising the use of the animals concerned, and minimising adverse welfare consequences to them. Our investigations show that there is an urgent need to update the TGs to reflect modern techniques and methods, and to use current approaches for applying refinement strategies to improve the scientific and animal welfare aspects of the procedures used. Improvements can and should be made in all aspects of toxicity testing, from sample preparation, and animal housing, care and feeding, to dose formulation, test material administration, and the histopathological and clinical analysis of tissue samples. Opportunities for streamlining individual assays are very limited, but testing could be made more efficient by: a) only undertaking studies that provide relevant data; b) making greater use of screens and preliminary testing; c) applying some tests simultaneously to the same animals; d) using one sex; and e) eliminating redundant tests. In conclusion, it is clear that, as they stand, the OECD Health Effects TGs are unsuitable for use in the European Union REACH system, for which potentially very large numbers of laboratory animals will be needed for the testing of a very large number of chemicals.

Animal Welfare↗
PubMed2003

FRAME and the Royal Commission on Environmental Pollution: common recommendations for assessing risks posed by chemicals under the EU REACH system.

This document discusses recommendations made by FRAME and the Royal Commission on Environmental Pollution (RCEP) with regard to the current European Commission proposals on the Registration, Evaluation and Authorisation of Chemicals (REACH) system for assessing the risks of chemicals to humans, wildlife and the environment. Of several common aims and recommendations, the two most important are: a) the greater use of non-animal testing methods, especially computational prediction methods (for example, [quantitative] structure-activity relationships, expert systems and biokinetic modelling) for prioritising chemicals for hazard assessment; and b) the greater use of intelligent exposure-based targeted risk assessment, with less emphasis being placed on tonnage-triggers. FRAME has produced a decision-tree testing scheme to illustrate the way in which these approaches could be used, together with in vitro test methods. This scheme has been slightly modified to take account of proposals subsequently made by the RCEP. In addition, FRAME points out that new and improved computational methods are needed through more coordinated research, and that these and existing methods need to be validated. The similarities between the independent publications of FRAME and the RCEP add weight to the recommendations that each have made concerning the implementation of the REACH system.

Animal Testing Alternatives↗
PubMed2003

Botulinum toxin testing in animals: the questions remain unanswered.

Questions are raised concerning the testing of botulinum toxin in animals, and the British Government's answers to Parliamentary Questions on this issue are reviewed, with an emphasis on the potential for reducing, refining and replacing the animal tests, which can involve substantial severity, and on the responsibility of the Home Office so see that the Three Rs approach is fully applied in this specific case.

Animal Testing Alternatives↗
PubMed2002

Future improvements: replacement in vitro methods.

Revolutions in thinking and practice are essential in regulatory toxicology if genuine protection of human beings and the environment is truly to be improved. New test development is the key: Tests should have greater relevance than the current animal procedures based on (1) a mechanistic understanding of the basis of the test method itself and of the toxic phenomenon of concern, (2) taking advantage of new developments in cell and molecular biology and computer systems of various kinds, and (3) a clear understanding of the value of good prediction models. In the not-too-distant future, current research in genomics, proteomics, and metabolomics should provide opportunities for the development of valuable new tests. An inescapable requirement of tests intended to be used for regulatory purposes is validation (i.e., an independent assessment of relevance and reliability for stated purposes according to internationally agreed-upon criteria). However, there is no standard validation scheme; a case-by-case approach is essential. It is important to take advantage of experience, which reveals that prevalidation makes formal validation studies faster, less expensive, and more likely to succeed, and that the procedures for independent assessment used by the European Centre for the Validation of Alternative Methods (ECVAM) and the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM) are effective in practice.

Animal Testing Alternatives↗
PubMed2002

The establishment of ECVAM and its progress since 1993.

The background to the establishment of ECVAM in 1991 is summarised, and progress made since 1993 is briefly reviewed in relation to 12 recommendations made at the ECVAM Opening Symposium in 1994 and to statements on tests for chemicals and biologicals endorsed by the ECVAM Scientific Advisory Committee since 1997.

Animal Testing Alternatives↗
PubMed2002

The principles of validation and the ECVAM validation process.

The validation of a test method is the process by which the relevance and reliability of the method are assessed for a particular purpose. It is an essential stage in the evolution of the method from its development to its acceptance and application for regulatory purposes. The principles according to which alternative tests should be validated have been agreed at an international level, although the actual process by which the validation process is conducted varies between different validation authorities. This paper summarises the principles of alternative test development and validation, and describes how the principles have been applied to the validation of in vitro tests by ECVAM.

Animal Testing Alternatives↗
PubMed2002

ECVAM's activities on biologicals.

This paper summarises key activities initiated and the progress achieved between April 1993 and June 2002 in implementing the Three Rs in one of ECVAM's priority areas - the production and quality control of biologicals. These have included: organising nine key workshops; financially supporting and/or participating in a number of prevalidation and/or validation studies; financial contributions and sponsorship to relevant international workshops, symposia and conferences; and financial support for the compilation of manuals and expert reports, and training in test methods. The paper complements the papers of Hendriksen et al. and Cussler et al. included in these proceedings.

Animal Testing Alternatives↗
PubMed2002

The future of ECVAM: a personal perspective.

Progress made in the practical application of the validation process is summarised, and some of the remaining problems are considered. Highlights of the first ten years of ECVAM are reviewed, andECVAM's activities as a route of communication on the Three Rs are discussed. Finally, some suggestions are made for maintaining ECVAM's momentum in the future, especially in relation to the challenge and opportunity for alternative methods afforded by the new EU Chemicals Policy.

Animal Testing Alternatives↗