Royal Commission on Environmental Pollution

Thank you for your letter of 19 October inviting initial thoughts on the scope of the Royal Commission's study on the long term effects of chemicals in the environment.

I understand that you are already in close contact with the Department about the study. I will not, therefore, attempt to summarise the current frameworks of chemicals assessment and regulation with which you are already familiar.

The three topics and eighteen issues identified by the Commission for the study seem to us to reflect the main concerns about chemicals. Thinking on these issues will develop over the course of the study as the EU Review on Chemicals Policy progresses and the UK Chemicals Stakeholder Forum takes forward its work. You will wish to be aware that the Stakeholder Forum has now - in accordance with the targets set in the Government's Chemicals Strategy - identified the criteria which it will employ to identify chemicals of concern (attached below).

The Department places great importance on incorporating public values into the process of chemicals assessment and regulation. Chemicals provide services to society and at the same time involve risks to people and the environment. The task of identifying the value which society at large places on the services that chemicals provide and the resulting risks is a difficult one. As you know, the Chemicals Stakeholder Forum, which has been given the task of reflecting public concerns about chemicals in the environment, has begun to consider how best this could be done. This is an area where the Royal Commission's study might helpfully focus.

The Department believes that there is a distinction to be made between short and medium term priorities and the longer-term vision. In the short and medium term, the main emphasis is likely to be on filling data gaps and addressing the current unsatisfactory position that there are many chemicals on the market where basic data on their impact on the environment is not available. The Chemicals Strategy envisages that industry and the Stakeholder Forum will review those of the International Council of Chemical Association's first 1,000 chemicals which meet the Forum's criteria for concern by 2005 and resulting risk management strategies will be in place no later than 2010.

In the longer term, the Strategy envisages that the internationally chemical industry will have evaluated all 4,100 high production volume chemicals by 2015 and carried out all necessary hazard assessments. By 2020 the Strategy envisages that industry will have provided at least sufficient data to characterise the hazards of all commercially produced chemicals. However, whilst we have to address the current lack of information about the safety of chemicals currently in use, we must also endeavour to minimise the animal testing that this may require.

We would also anticipate that, in the longer term, more sophisticated means of risk assessment and prioritisation will be developed, in addition to testing methodologies that obviate the need for using animals. For example, chemicals are often designed for specific purposes and their properties reflect the purposes to which they will be put. It may be helpful in the future to look more carefully at the uses for which chemicals are designed and identify the associated properties that cause concern.

The large scale use of industrial chemicals has led in the past to unanticipated problems such as ozone depletion and concern about more subtle impacts such as endocrine disruption, effects on neurobehavioural development and on the immune system which may occur at low levels of exposure. A major issue for the future is whether we can improve our knowledge about chemicals so that we can identify those that may have effects on people and the environment. At the moment, we use criteria such as persistence, bioaccumulation and toxicity as indicators of potential harm to identify chemicals which require further investigation. Current monitoring strategies focus largely on identifying the presence of chemicals which we know are already of concern, but there may well be other chemicals present for which action may need to be taken to minimise problems arising.

The Royal Commission's study might helpfully review the state of development of other approaches - such as biomarkers, identification of key environmental indicator species for effective monitoring, and direct toxicity assessments - and whether such approaches might form part of a broader strategy for protecting the environment from harm caused by chemicals.

Officials would be very happy to provide the Royal Commission with any information that it requires during the course of the study.

Introduction
The UK Government Chemicals Strategy - published in December 1999 - set out the Government's policies to prevent commercially produced and used chemicals from harming the environment or (via environmental exposure) human health. The Strategy sets out a fast track procedure for taking action on the chemicals of most concern. This requires the development of criteria which will enable chemicals that require a risk management strategy to be identified quickly. As a first step in this process the UK Chemicals Stakeholder Forum - established in September 2000 - was asked to agree criteria to identify the chemicals of greatest concern, taking into account the key properties of persistence, bioaccumulation and toxicity (PBT).

The Stakeholder Forum held an initial discussion on criteria at its first meeting on 2 October 2000. The Forum considered information on work in other fora (particularly that developed under the OSPAR Convention to prioritise action on substances which pose a threat to the marine environment) in reaching its conclusions on criteria for priority chemicals for the UK and for all environmental media.

An ad-hoc meeting of the Forum, held on 3 November, considered in more detail the implications of different sets of criteria. The discussion was based on a paper produced by the NERC Centre for Ecology and Hydrology, which looked at how different criteria selected substances from a sample of chemicals considered under OSPAR.

The Forum held a further discussion on 30 November and agreed to recommend to Government criteria which would enable all relevant information to be taken into account. The Forum received further information on an OSPAR exercise to identify the numbers of chemicals which might be selected by five different sets of criteria.

Stakeholder Forum recommendations on criteria (as agreed on 30 November 2000)
Persistence
t ½ water > 2 months OR

t ½ soil or sediment > 6 months

The Forum recognised that such half life data may frequently not be available and that screening data such as the results of ready biodegradation testing may need to be used in the first instance.

Bioaccumulation
Log Kow =5 for the substances of highest priority, unless the experimental BCF <5000

Log Kow =4 for other priority substances for the Forum, unless the experimental BCF <500

Where experimentally derived bioconcentration factors (BCFs) were available these would be given precedence over Log Kow.

Toxicity
Toxicity or ecotoxicity data that indicate potential for damage, in the immediate or longer term, and through direct or indirect effects. Such data may include acute and/or chronic aquatic toxicity data, with thresholds of L(E)C50 = 1 mg/l and long-term no observable effect concentration (NOEC) = 0.1 mg/l respectively; and category 1 and 2 carcinogenic, mutagenic or reproductive toxins (CMR) and category 3 mutagens, or chronic toxicity data, with reference to the thresholds and provisions set out in EC Directive 67/548/EEC.

If no toxicity information is available from animal tests, QSAR or expert judgement, it would be assumed that the toxicity criterion was met.

Persistence and bioaccumulation without toxicity
If persistence and bioaccumulation criterion were met but the toxicity criterion was not, the Forum would not assume that the chemical was safe, but it would not be as high a priority as chemicals which met the toxicity criterion.

Safety net procedure
A safety net procedure would apply where chemicals did not meet the PBT criteria but there were reasons to believe that the chemicals raised equivalent concerns. It was anticipated that chemicals giving rise to concerns related to endocrine disrupting effects could be considered under this procedure. The Forum would receive expert advice in such cases.

Next steps
Following agreement by members, the Forum's criteria will be applied - with advice from the Advisory Committee on Hazardous Substances and other relevant advisory committees - to data from the ICCA programme and other relevant data. Chemicals which fulfil the criteria will then be fast tracked for consideration of risk management as set out in section 3.4.2 of the Government Chemicals Strategy.

The Stakeholder Forum also agreed on 30 November 2000 to consider proposals from the Secretariat for second tier criteria at its third meeting in March 2001 with a view to finalising such criteria at its fourth meeting in June 2001.

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