Royal Commission on Environmental Pollution

Comments on the Issues Identified by the Commission

1.   The biological species, environmental pathways and adverse effects of most concern
The biological species of most concern will depend largely on site specific issues (i.e. environmental quality objectives) such as conservation value (e.g. Natura 2000 sites) and the exploitation of the site for food resources. Thus, species of concern will include those which are most sensitive or most vulnerable and suffer irreversible effects - this will not always be humans, although they are often given priority. Often unable to identify which species are of concern as we do not have a sufficient understanding of interactions between species. An effect on the functioning of an ecosystem (e.g. microbial decomposition) may have more severe impacts in the longer-term than the effect on a species (e.g. invertebrates).

All environmental pathways are of concern, as the hydrological cycle links them all.

Adverse effects of most concern must include those ultimately impinging on the food chain and human health, including the potential for carcinogenicity, mutagenicity and reproductive toxicity (latter includes endocrine disruption) and also more subtle effects such as those on intelligence and mood. Also important are those effects which are irreversible and only become manifest after the damage has been done. Pathways lead to sinks and often soil is the ultimate sink for many chemicals. However, there has been no systematic survey of the deposition or application rate, accumulation or fate. In addition, we know very little about the long-term impacts on soil processes or sustainability. The soil's ability to filter or buffer pollutants must be sustained and at the moment we do not have the information to access this. There are many practices such as the disposal of sheep dip chemicals where impacts on soils are not taken into account. Increasing attention appears to be given to quantitative risk assessment and to demonstrating source-pathway-receptor links before taking regulatory action (e.g. contaminated land regime). This is acceptable as a driver to justify remediation of a site but not a priori in aiming to protect a site from inputs.

2.   Whether the standard test methods adequately determine the environmental behaviour and long-term environmental effects of chemicals
Standard test methods are not representative of environmental conditions and do not enable environmental behaviour (for example, biodegradation rates) to be accurately predicted (especially for organic soils). For example, degradation and mobility of organic chemicals in soil in highly dependent on their availability, which is often dictated by labile and non-labile sorbed fractions. Standard tests are carried out on spiked soils, which do not taken into account the sorption and ageing processes in natural soils.

Chemical regulation generally relies on a risk based approach where a Predicted Environmental Concentration (PEC) is compared with a Predicted No Effect Concentration (PNEC). The nature, extent and cost of testing and assessment depends on the calculated risk to the environment (e.g. PEC:PNEC risk quotient).

There is rightly a need for standard test methods (e.g. Daphnia test and log Kow) to be used in the initial stages of hazard assessment. Higher tier testing tends to focus on more locally relevant species and on more complex ecological processes. Such testing does not normally focus on long term effects.

Traditional analytical chemistry techniques require development to allow speciation and differentiation of compounds. Lower detection limits and greater accuracy and precision are required for many substances (often environmental quality criteria do not exist so it is difficult to determine appropriate detection limits). There are a number of areas of science which are still to be utilised in the assessment and regulation of chemicals and toxicity in the environment. For example, biomarkers should be more fully developed and approaches such as genomics offer considerable potential. It is essential that we have robust sensitive and meaningful indicators of adverse biological effects in the wild. There is a need for partnership between chemical and biochemical measures on the one hand and improved methods of biological effect assessment on the other.

3.  The balance between the desires for toxicity testing and animal welfare
Emphasis should be placed on developing alternatives to animal testing and preventing unnecessary testing through the central collation of test results.

This issue (ethical review) has quite rightly received increasing attention in recent years and is arguably more for the ethicist than the scientist. Effort should made to use the lower life forms for testing where possible and to reduce-refine-replace the use of vertebrates (particularly primates). The nature of the testing and the severity of animal suffering should always be balanced against the needs and benefits arising from the work.

4.   The development and use of predictive methods to fill data gaps
Predictive methods and models do have a place, but should be validated to ensure that their predictions are accurate and their uncertainty established/demonstrated; the quality of models varies greatly and in part depends on the nature of work undertaken to calibrate them.

A wide variety of models exist from simple physical dispersion models to detailed fate/behaviour (fugacity) models and quantitative structure activity relationships (QSARs). One can distinguish between detailed research type models and simpler routine operational models.

Models help us to explain the behaviour of systems and provide a useful first approximation. They can be used as part of a cycle to inform and optimise environmental monitoring and assessment e.g. making sure that we look for the right substance in the right place at the right time.

5.   The adequacy of chemical and/or biological monitoring to help evaluate predicted behaviour and discover unforeseen effects
Biological monitoring is useful as it provides an insight into the actual does received.

This issue raises an interesting point. We often monitor what we can and hope that this provides a reasonable statement of the quality of the environment. This practice poses the danger of being naive and inadequate. Much of our monitoring is designed to detect gross effects on environmental quality and the more subtle effects of contaminants go undetected. Much emphasis is paid to chemical specific monitoring of a small suite of 'priority' contaminants backed up by fairly gross impact assessment via the invertebrate community structure (not function) of the receiving environment. There are many other approaches to biological monitoring which could be developed and applied and are which are well exemplified in the approach to marine monitoring manifest in the UK National Marine Monitoring Programme (also note increased emphasis on ecological quality arising from development of the Water Framework Directive).

We should aim to look for the right substances in the right place at the right time and hence the value of models in the cycle 'prediction-monitoring-assessment-control'. We have a history of not doing this and there are dangers in regulators such as SEPA having to do this regardless of whether it is appropriate or not e.g. monitoring Red List substances in water and effluents (cf sediments and biota).

Monitoring programmes are often ill conceived forcing us to look at inappropriate environmental media e.g. the Red List monitoring of DDT etc. These European programmes raise awareness but the scientific basis behind them should be more clearly specified. Terms like de minimus need much better definition in determining chemical levels of concern and, thereby, the requirements for improving the performance characteristics (e.g. detection limits) of analytical methods. Is it always necessary to keep driving detection limits down?

6.   The chemicals that should be assessed most urgently (are those produced in quantities over 1000t/yr the greatest concern?)
Quantity per se is not the issue: PEC:PNEC is; The chemicals that should be assessed most urgently are those which are of greatest environmental concern (toxicity, persistence, mobility) and which are most likely to be released into the environment - this does not necessarily correlate to those produced in high volumes. SEPA is concerned about several pesticides used in aquaculture to remove sealice. However, production is an indicator of use/input and thus is of some (albeit limited) value. It was one of the criteria used in the identification of priority substances for Red List.

This issue is being addressed in the UK by the Chemicals Stakeholder Forum.

7.   Dealing with uncertainty and/or lack of data in the assessment process
Uncertainty is inherent - there is no clear dividing line between harm and no harm. Randomly applying factors to account for uncertainty can lead to over conservatism and work should be undertaken to address underlying uncertainties e.g. lack of data on toxicity or environmental behaviour.

This is often addressed by the use of safety factors, the magnitude of which depends on the nature, quantity and quality of the data and hence the degree of uncertainty in the hazard assessment and the derivation of the PNEC.

We frequently encounter problems with lack of toxicity data on relevant taxa. Can we extrapolate from freshwater to salt water organisms, and from soils to sediments? Can we extrapolate from the lab to the field, from single species tests to ecological effects? These are all familiar questions.

8.   The speed of the current assessment process
The process of risk assessments for existing substances appears very slow - hence the value of the Chemicals Stakeholder Forum. By the time a substance appears on a priority list it is often no longer in use. EC Directives such as those for Dangerous Substances bear little relation to the substances that are currently causing environmental problems.

9.   The pros and cons of different approaches to assessment, for example comparative assessment, assessment of groups of substances, hazard- versus risk-based approaches
Hazard based assessment is a useful screening process.

Risk-based approaches are preferred to hazard-based approaches in that they are more environmentally relevant.

It is possible and quite sensible in some cases to assess groups of substances particularly where they exhibit similar behaviour and modes of action e.g. atrazine and simazine, organo-phosphates, dioxins and furans.

Within the scientific and regulatory communities the assessment process is reasonably open and well understood. However, the many varied priority lists and regulations are confusing. The public generally have a poor understanding and mistrust of this process. Much greater effort is required to involve the public in this area. This process is improving with increasing use of stakeholder fora.

10.  The operation of the Precautionary Principle in chemical assessment and control
The onus should be more on a producer to demonstrate that a chemical is "safe" rather than use being allowed while there are still question marks over its safety. This is well justified, particularly in the case of protecting high quality environments and has been the subject of much scientific debate.

11.  The role of the Substitution Principle in chemical control (including its possible extension to consider non-chemical solutions)
It is sensible to replace hazardous chemicals with less hazardous ones where possible. We should aim to develop cleaner technologies and thereby 'design out' of process those substances likely to pose a threat to environmental quality.

Restricting or banning the use of compounds in certain industrial sectors can be a very effective method of control (e.g. success of simazine and atrazine restrictions on non-agricultural applications). Blanket bans are draconian for most compounds .... even for the likes of DDT. It is the use or method of use and not the compound itself which is the problem. We often spend too much effort studying the substance and not enough effort in studying how it is used i.e. assessing potential release to the environment.

Rather than banning or substituting a substance (this can lead to the introduction of substances we know even less about) more effort should be directed at investigating efficient methods of use which minimise the release to the wider environment.

12.  The incorporation of people's values into the process
This is a difficult issue - people may underestimate the value of basic chemicals (e.g. chlorine) whist overestimating the necessity for chemicals such as pesticides. The situation is made more complicated by arguments being put forward only by those who seek to profit from use of a chemical. We must take account of stakeholder views and determine and work towards a level of environmental quality which society can afford.

13.   The responsibilities of producers and users of chemicals (assisting assessment and product stewardship)
Producers should be made more responsible for the chemicals that they produce, and part of this responsibility should be passed onto users. This not reflected in 'duty of care'.

14.   The openness and transparency of the assessment process
The assessment process does not appear very open and transparent. SEPA is not a competent authority under NONS/ESR/COPR and appears to have limited access to information arising from the assessment process (it took a long time to access data held as part of NONS by EA on sites which SEPA regulates).

This is an important issue and it is good to see it in operation in the web site for RCEP.

15.   The respective roles of, and most effective co-ordination between national and international bodies in the assessment and control of different types of chemical and exposure route
Greater emphasis needs to be placed on follow-up of environmental effects of chemicals, particularly those approved for use. This can only be done through close liaison between the licensing authorities and the environmental regulators.

Might consider trans-boundary movement of contaminants and the sensitive issues of carrying capacity and critical load.

16.  Gaps or deficiencies in the present coverage of regulation, how these should be filled, and the extent to which existing regulatory codes need to be integrated or made more consistent in their approach at both national and international levels
Production is well covered if it is regulated under the PPC Regulations; use is largely unregulated and therefore represents the biggest deficiency in regulation.

Initiatives such as the Biocidal Products Directive should help in ensuring consistency in the assessment of different types of 'biocides'.

17.  The effectiveness of different types of control and/or mitigation
Over the years (at least for the water environment) we have seen an evolution from point of discharge controls (e.g. consent limits), to process emission controls under the Integrated Pollution Control (IPC) regime, to implementation of IPPC and BAT (i.e. a more holistic and integrated approach to environmental impact assessment).

18.  Tensions between free trade and environmental protection
Should barriers to free trade really over-ride the need of a country to protect an aspect of its environment that no other country has?

Free trade at what price? We can identify different scales of releases and impacts ranging from local, regional, national, international, and inter-continental. Each requires a different approach and forum for management.

Details of Relevant Initiatives and Studies
Work is being carried out developing an understanding of the long-term health effects of chemicals in the environment, but there appears to be little co-ordination of this work. Links need to be improved between those involved in environmental protection and those involved in health protection (HSE, Health Boards, Local Authorities) - overlap does not appear to be appreciated or recognised. In particular chronic toxicology should have a greater role in environmental protection (just how many environmental standards are based on the concept of tolerable daily intake and use representative exposure scenarios?). There is a committee on toxicology which we gather looks at the toxicology of chemicals such as benzene (and perhaps even pesticides). We are not aware that this committee has links into those involved with protecting the environment.

Examples of initiatives:

· Scottish Group culminating in publication "dealing with assertions of human health risks from environmental exposures: a systematic approach";
· Inter-departmentaI liaison group on risk assessment (ILGRA) - attempting to get dialogue going (although limited representation i.e. SEPA not involved). Annex to IGHRC annual report highlights research activity
· National Focus for work on response to Chemical Incidents and Surveillance of Health Effects of Environmental Chemicals. This Government funded unit is attempting to address the role of Health Authorities in chemical incidents and to collate data on environmental exposures. Relationships with environmental regulators could be usefully established.
· Framework for deriving numeric targets to minimise the adverse human health effects of long-term exposure to contaminants in soil: SR99(02)
· A guidance manual and protocol for assessing potential adverse effects of substances in soil on designated terrestrial ecosystems: SR(99)01
· Communicating Understanding of Contaminated Land Risks: SR97(11)
· the Environment Agency, on behalf of UK Government, set up the Pesticides in the Environment Working Group (PEWG) to consider the overall balance of monitoring activities on pesticides, veterinary medicines and biocides in the environment and to make recommendations for improvement; a key goal was to identify deficiencies in monitoring programmes and consider further needs.

· classed as medicines (officially list 2 dangerous substances) and used to remove sealice;
· copper-based antifoulants (classified under the Pesticide Regulations) used on nets (these form copper complexes in marine sediments); and
· nutrients.

We have tried to combine modelling and ecotox data to control these - using our own ecotox standards. One issue is that the ecotox standards are not set with the ability of models in mind eg annual average concentrations. So, there is a need for joined-up-thinking between modellers and ecotoxicologists or standard setters. Modelling of nutrients is undertaken by others (including the Scottish Executive's Marine Lab at Aberdeen).

Another issue is the lack of ecotox data on relevant species. The standard tests are not often on commercially or local important species. It is important that the species tested is widened rather that just using half a dozen standard tests developed 20 years ago.

At present we have not looked at modelling the long-term fate, eg what happens when substances move away from cages into the wider environment. We have allowed them to breakdown and decay on site or be removed by re-suspension or dispersion. Some methodology for assessing this would be useful.

Although most of this discussion has focused on medicines or chemicals, the same issues are equally true of nutrients, where, as you may be aware, there is heightened debate about their release to the marine environment. Again, we poorly understand long-term cycling and interactions between coastal and offshore processes.

After use, most chemicals quickly disperse to concentrations we cannot measure, and thus the only way of keeping tabs on them is via models. Thus, it is essential that the pathways for the chemical moving within the environment is understood before it is used, and that we have developed and calibrated suitable models before it is used. At present using the fish farm example, we are always being pushed by commercial or political pressure.

One of the big problems we have faced is a lack of joined-up regulation between the Veterinary Medicines Directorate (VMD) of MAFF and SEPA - VMD regulates the development of veterinary drugs; SEPA control the release from fish farms under the Control of Pollution Act. Although we have improved our regulatory controls, a more overarching piece of regulation would be helpful. This story is even more extreme for pesticides, where the HSE's pesticide unit (PSD) regulates both development and use - SEPA only monitors the environment.

Despite these uncertainties, we have used the models to established sediment and other environmental quality standards (which have been peer reviewed by the Water Research Centre) and site specific discharge consents are applied to meet these standards.

Examples of Practical Difficulties or Good Practice
An example of poor practice would be DETR's development of the contaminated land exposure assessment model as a mean to assessing chronic risks to human health from contaminated soils (lack of consultation and validation of the model early on, lack of co-ordination on collection of toxicological data).

Miscellaneous Issues
A few issues that spring to mind:

· accounting for atmospheric deposition when regulating emissions to atmosphere
· accounting for sediment deposition when regulating emissions to water
· establishment of scientifically, toxicologically sound, emission limit values
· how dose can be estimated from inhaled dust e.g. what proportion of chemical transfers across lung into blood
· how can dose be estimated from dermal contact e.g. proportion of chemical transferred across skin into blood
· what is an acceptable level of protection for carcinogens
· what are we trying to protect in terms of ecosystems, when so many different species with poorly defined relationships between them
· role of direct toxicity assessment, particularly for terrestrial ecosystems where there is little toxicity data available
· how are chemicals transferred across the foodchain
· what is the long-term capacity of soils to degrade and sorb chemicals without quality and functioning being impacted
· what is the long-term capacity for chemicals to be degraded in aquifers.

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