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Royal Commission on Environmental Pollution
On 24 October 2001, the Royal Commission sent the following letter to over two hundred organisations and individuals. The Commission would welcome written information from any other body or individual who wishes to submit views on the is22 March, 2007 href="http://webarchive.nationalarchives.gov.uk/20090128002317/http://www.rcep.org.uk/chem-inv.htm#letter">Invitation to submit evidence
ROYAL COMMISSION STUDY ON LONG-TERM EFFECTS OF CHEMICALS IN THE ENVIRONMENT - INVITATION TO SUBMIT EVIDENCE
The Commission announced its intention to study the long-term effects of chemicals in the environment in October 2000. Since then, it has been scoping the Study. A summary of the work carried out during the scoping phase, with more background on the Study is attached at annex A. The Commission is now ready to begin the Study in earnest.
The central aim of the Study is to analyse the key issues and make recommendations designed to reduce the chance that chemical use will cause long-term damage to the natural environment or human health. To help with this task, you are invited to submit evidence on the Study. A list of issues upon which the Commission is particularly interested in receiving evidence is attached at annex B. This consists of a series of underpinning assumptions, followed by a menu of possible guiding principles that could be adopted, concluding with more detailed questions on chemical assessment and control.
The deadline for responses is 1 February 2002.
It would be appreciated if, where possible, submissions could be sent by e-mail to email@example.com . Printed reports and references can be sent separately by post.
You do not need to address all the issues listed; indeed, you may feel that you can provide useful evidence on only a few. It will be helpful to the Secretariat if you can use the numbering given in annex B to indicate which of the issues each section of your response addresses. You may wish to go beyond the attached list of issues. If so, or if you have any queries on what the Commission is seeking, please contact me at the above number.
While the Commission is always interested in opinions of interested parties on the topics it studies, you should bear in mind that the principal goal of this invitation is to elicit responses drawing the Commission's attention to documentary evidence or argument to support particular views.
Shorter, informal submissions can also be made by posting messages on our website discussion forum at http://www.rcep.org.uk/chemicals where you can also respond to other postings. The discussion forum has been reconfigured to make it easier to use and I hope that you will find it a useful means of exchanging views on chemical issues, as well as making contributions to the Commission's Study.
Unless indicated otherwise when evidence is submitted, it will be assumed that the organisation or individual submitting it has no objection to its disclosure to other parties should the Commission so decide. The most likely method of such dissemination is through publication on the Commission's website.
This letter has been sent to a wide range of stakeholders and interested parties (listed in annex C), and has been posted on the Commission's website. If you think that we have missed any individual or organisation that might like to contribute, feel free to either contact me or pass a copy on to them directly.
I look forward to hearing from you.
Background to the Royal Commission's Study on the Long-term Effects of Chemicals in the Environment ('the Chemicals Study')
The Royal Commission
The Royal Commission is an independent standing body established by royal warrant in 1970 to provide advice on environmental issues. Its primary role is to contribute to policy development in the longer term by providing an authoritative factual basis for policy-making and debate, and setting new policy agendas and priorities. In reaching its conclusions, the Commission seeks to make a balanced assessment, taking account of the wider implications for society of any measures proposed.
The Chemicals Study
The developments in the chemical industry during the last 150 years have brought spectacular benefits to mankind. On the other hand, the manufacture and use of chemicals creates risks to the natural environment and humans, many of which are poorly characterised. There is a long history of chemicals that were originally thought to be purely beneficial turning out to have adverse effects on the natural environment, ecosystems, and human health as a result of their release: for example DDT and the decline of raptor populations as a result of egg shell thinning; PCBs and reproductive effects in humans and other vertebrates; and CFCs and the ozone layer.
Despite a large, and rapidly growing, national and international effort to assess the effects of chemicals in the environment, major doubts persist as to the effectiveness of present policies in protecting the health of both humans and ecosystems from unintended long-term effects. This concern needs to be balanced against the benefits of chemicals to society.
The Commission decided to address this issue and announced its intention to do so in October 2000. The central aim of the Study is to analyse the key issues and make recommendations designed to reduce the chance that chemical use will cause long-term damage to the natural environment, or human health from exposure mediated by the environment.
The invitation to submit written evidence on key issues marks the formal start of the Study. The Commission will build upon the evidence it receives with a series of meetings with key stakeholders (some in the form of oral evidence sessions), visits and consideration of papers produced by its Secretariat. The report is due to be published in mid-2003.
The Announcement of the Study
The Commission's announcement identified three major themes:
The full text of the original announcement of the Study can be found on the Commission's web site at: http://www.rcep.org.uk/chemicals.htm
The Commission has received and considered 44 responses to the announcement of the Study (also available on the it's website). As a result it has decided not to limit the types of chemicals covered by the Study, provided they are traded, or incorporated into products, or are substances that derive from such activities. The primary focus will be on how decisions are taken about their use and/or control. While the Commission may wish to use case studies to illustrate various points, individual chemicals and their uses are not the primary focus.
The Commission Working Group
There are many challenges posed by the Study. A Commission working group has considered some of the issues raised by the current state of scientific knowledge and risk assessment techniques. Its interim conclusions are that:
It has been suggested that reassurance can be derived from experience - health and longevity have improved despite exposure to a wide variety of chemicals; but this could be attributed to an absence of evidence of subtle, but potentially important effects, rather than evidence of their absence. There are many historical examples, from ozone depletion to endocrine disruption, where unexpected effects have been discovered and it would be naïve to think that our current understanding precludes further surprises.
The Working Group believes that further research and testing are at best only partial solutions to the problem and has identified several aspects to the problem facing those who wish to demonstrate chemical safety:
Producers of industrial chemicals, who are responsible for the submission of datasets to the regulators, often do not know how or where their chemicals are incorporated into products, the conditions under which these are used, and their potential for release through use or disposal. Supply chains may be long and can be shrouded in commercial secrecy.
Modelling the fate and transport of a substance in the environment is plainly difficult. Transport in the atmosphere or in water can lead to limited regions of high concentration rather than uniform dilution. There are many ways in which a chemical may break down, with each process dependent on a variety of environmental factors. Poorly understood bioaccumulation and food chain processes further confuse the exposure picture. Many of these processes can be modelled, but the models are severely limited by either lack of data, or variation in those that are available.
There is insufficient monitoring of both the state of environmental systems, which might provide early warnings of problems, and the broad sweep of substances to be found in the environment. Monitoring of chemicals in the environment in the UK and elsewhere tends to focus on well-known, heavily regulated pollutants. Often, where measurements do exist, they have not been made in the media where the highest levels of the target substance would be expected. In any case, risk assessment finds it difficult to incorporate monitoring results.
The calculation of environmental 'no effect concentrations' also includes large uncertainties. A handful of standard test methods are available to test toxicity to environmental species. The results of these tests are extrapolated to produce an estimate of levels that might cause effects in the environment. To do this, assumptions have to be made about the reliability and reproducibility of the test methods and the relationships between: the sensitivity of the species, life-stage and sex tested and that of all other species; the laboratory and environmental conditions; acute and chronic exposure; and inter- and intra-species effects. It is generally assumed that effects are only additive, and not synergistic. This is likely to be reasonable for most substances, but probably not for all (and nobody knows which these might be).
Most chemicals have little or no interpretable toxicity data. The ability to predict human or environmental toxicity without recourse to animal or tissue experiments seems very limited at the moment. Quantitative Structure Activity Relationships (QSARs) and rule-based expert systems might be useful for priority setting, but they seem too unreliable and limited in application to provide any real help in risk assessment. In vitro test methods exist for only a few endpoints and there seems little prospect of any dramatic shift away from in vivo testing, without acceptance of much greater uncertainty in the assessment of adverse human effects.
There is also the question of whether the standard toxicity tests are able to measure endpoints of concern. Endocrine disruption effects arising from environmental chemical exposure is an example of an effect that could not be picked up by the current standard chemical assessment dataset. In this case, as in several other infamous environmental effects arising from chemical exposure, the alarm was raised by observations in the environment, rather than predictions from chemical datasets. Even in cases where there is strong scientific evidence linking the use of particular chemicals to environmental harm, there has been a very slow policy response to the threat, often measured in decades.
Comments on the EU Review of Chemicals Policy
Members have considered the European Commission's recent White Paper on Chemicals, and responded to consultations from DETR and a Parliamentary Select Committee on the issues it raises. The main points of the responses were concerns over the effectiveness and feasibility of the proposals, the implications for animal testing, the lack of public involvement in the process, and the need to consider alternative approaches to determining chemical safety. The Commission awaits the Select Committee's report with interest and will take their findings into account during its own Study.
Literature Review of Chemicals and People's Values
Consultants at the University of Edinburgh have undertaken a literature review on behalf of the Commission. This showed that there are relatively few independently researched studies on people's values with respect to chemicals. Those that do exist show that public perception of the chemical industry and its products has been in a slow but steady decline, and is so poor that there is a risk of sudden public reaction to minor events due to social amplification. The authors concluded that there is a need to find mechanisms for accommodating interest-based and value-based positions in policy and regulatory decision-making.
Royal Commission Seminar
The Commission held a seminar on 'Fresh Approaches to Chemical Use and Control' on 19 July 2001 involving representatives from a wide variety of interested parties.
There seems a general acceptance that the current system of assessing and controlling risks is unsatisfactory. However, there is a broad spectrum of views as to what should be done about it. These views can be broadly separated into three strands:
Among the issues raised at the seminar were:
A fuller summary of the issues raised is available on the Commission's website.
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