Your Daily Poison - Pesticide Action Network UK

Your Daily Poison - Pesticide Action Network UK Your Daily Poison - Pesticide Action Network UK

05.06.2013 Views

14 4 Discussion Since the last report there have been a number of important developments at both a national and international level. We review below the most significant for UK pesticide regulation, in terms of human health, in 2005. The evidence of exposure we have presented in this report should be considered in this wider context. The new report by the Royal Commission on Environmental Pollution, ‘Crop spraying and the health of residents and bystanders’, has created a potential for change in pesticides policy. It is the most authoritative UK report on the health risks of pesticide exposure for at least fifteen years, and PAN UK welcomes its thorough analysis. However the recently published government response has been disappointing 35 . The new All Party Parliamentary Group on Pesticides and Organophosphates was formed in 2005 (Appendix 7). A finding in the RCEP report is that illnesses reported by people exposed to pesticides do not match the symptoms that might be anticipated from toxicological tests on laboratory animals. This supports the information collected routinely by PAN UK when people report their exposures and symptoms. The latest discoveries in toxicology, especially in relation to the insidious effects of endocrine (hormone) disrupting chemicals, indicate that there must be changes to regulatory toxicology. The true costs of ‘endless tests’ must be disclosed and the issue openly debated. The public should be informed by government about the current coverage of tests and its costs, and gaps where there is no knowledge. There should be public participation in the approvals of pesticides and in decision-making about testing, and its costs. The process should be open to scrutiny not only by government regulators, the scientific community and the agrochemical industry, but also by civil society. The need for regulatory reform The RCEP has confirmed concerns expressed for many years by PAN UK. It identified that ‘the PSD combines both delivery of the pesticide approval process and policy advice to Ministers on pesticides’, and that ‘there is a danger of a conflict of interest, which may be greater where funding is derived from outside government 36 .’ ‘An executive agency of the government, the PSD is funded by government for its policy work, however the full costs of evaluating applications for pesticides approval are recovered from the industry through fees and levies. In the year 2003/04 the PSD received £4.363 million from the levy for regulatory work which includes monitoring and compliance and £2.791 million in industry fees for evaluating applications … [In the same year the PSD received] £5.379 million .. from Defra for policy-related activities.’ 37 PAN UK welcomes the long-overdue recognition that these arrangements have profound implications for the governance of pesticides. We support the RCEP recommendation that government bodies should not hold responsibility for policy and for its execution on the same issue …. [and that] these issues should be separated between a government department and an arm’s length executive agency or non-departmental public body 38 .’ The need for biomonitoring and health outcome surveillance The RCEP says ‘We were surprised to find that no efforts have been made to establish a database of baseline information for agricultural pesticides that are commonly used in the UK. The principle behind comparing an individual’s level with the population norm … is an entirely standard method of proceeding in many areas of clinical diagnosis. Baseline information is being collated in other countries, notably in North America and Germany, and could be used as a framework for information that could be collected in the UK… data on levels of exposure in the population would allow comparison with biomarker levels in an individual subject and provide an understanding of whether the level is unusual and in a range that might lead to an adverse effect. This information could be compared to symptoms of ill health and analysed for trends. 39 ’ PAN UK has advocated a biomonitoring programme along the lines of the US National Health and Nutrition Examination Survey (NHANES) 40 to regulators for many years. We followed up the RCEP recommendation by advocating at a recent PAN Europe annual Your daily poison

conference that a Europe-wide biomonitoring programme and long-term health outcome surveillance programme should be started. The RCEP identifies that the weakness in most epidemiological studies on pesticides is the ‘considerable difficulty of quantifying exposure and identifying the particular pesticide or coformulant mixture concerned 41 .’ Formerly one of the most senior government toxicologists in the UK, Dr Tim Marrs considers that ‘Epidemiology is usually of little value in pesticide evaluation’, and that ‘the impact on pesticide regulation [for single pesticides] of epidemiological studies has been small, with the possible exception of 2,4,5-T in the 1970s 42 . Dr Marrs subsequently commented that if a serious effect was occurring post-marketing, something might be expected to be observed in a large number of epidemiology studies. The Advisory Committee on Pesticides describes the system for the review of epidemiological studies carried out by its Medical and Toxicology Panel as one of the key measures in place to check for possible adverse effects once a pesticide has been approved 43 . At the root of failing risk assessment: inadequate toxicity testing Questions are now being asked in the most respected scientific journals about the effectiveness and relevance of toxicological tests on laboratory animals which form the basis of current regulatory safety assessment of chemicals including pesticides. For example, the science journal Nature, reporting a new initiative by the European Commission to develop alternatives to animal testing acknowledges the poor quality of most animal tests, that they are ‘wasteful and poorly predictive’, and are ‘stuck in a time warp.’ 44 According to the report, Thomas Hartung, head of the European Centre for the Validation of Alternative Methods (ECVAM) in Italy said, ‘toxicity tests that have been used for decades are simply bad science.’ Nature’s senior European correspondent Alison Abbott remarks that the experiments have ‘never undergone the rigours of validation that in vitro alternatives now face. Most animal tests overor under-estimate toxicity, or simply don’t mirror toxicity in humans very well.’ The current system has not always detected the evidence scientists have discovered in ecological phenomena of the harmful effects of chemicals. The recent Prague Declaration on Endocrine Disruption 45 (Appendix 8), which over 200 scientists have signed, states that ‘the existing safety assessment framework for chemicals is ill-equipped to deal with endocrine disrupters. Testing does not account for the effects of simultaneous exposure to many chemicals and may lead to serious underestimations of risk … A fundamental element of chemical safety assessment is the assumption of a threshold dose below which there are no effects. This may not be tenable when dealing with endocrine disrupters, because certain hormonally active chemicals act in concert with natural hormones already present in exposed organisms. Thus even small amounts of chemicals may add to the overall effects, irrespective of thresholds that might exist for these chemicals in the absence of natural hormones. Additionally, due to limited sensitivity of established test methods, it is likely that effects are overlooked.’ The RCEP concurs with the signatories of The Prague Declaration in advocating the development of new assays and screening methods which should ‘take advantage of modern technologies such as genomics, proteomics, bioinformatics and metabonomics’: ‘the element of uncertainty inherent in using animal models might be reduced by the development of the new integrated and molecular based technologies, such as the use of toxicogenomic methods or human cell culture models and the development of animal models of multisymptom/multisystem disease. … Toxicogenomics is a tool in development, but it has the potential to inform and improve risk assessment in the future … Under strictly controlled experimental conditions, human cell culture models can be used to re-create human cellular function in an in vitro environment … This could reduce the need for animal models and animals for experimentation and deserves further exploration for those involved in pesticide regulation 46 .There is, however, considerable scientific disagreement on the how accurately different forms of testing can predict outcomes 47 . The relevance of animal data to human disease is questionable when considering the wide inter- and intra-species variability of just one toxicological endpoint, the lethal dose (Appendix 9). Data from the same species but the second UK pesticide exposure report 15

conference that a Europe-wide biomonitoring<br />

programme and long-term health outcome<br />

surveillance programme should be started.<br />

The RCEP identifies that the weakness in most<br />

epidemiological studies on pesticides is the<br />

‘considerable difficulty of quantifying exposure<br />

and identifying the particular pesticide or coformulant<br />

mixture concerned 41 .’ Formerly one of<br />

the most senior government toxicologists in the<br />

<strong>UK</strong>, Dr Tim Marrs considers that ‘Epidemiology<br />

is usually of little value in pesticide evaluation’,<br />

and that ‘the impact on pesticide regulation [for<br />

single pesticides] of epidemiological studies<br />

has been small, with the possible exception of<br />

2,4,5-T in the 1970s 42 . Dr Marrs subsequently<br />

commented that if a serious effect was<br />

occurring post-marketing, something might be<br />

expected to be observed in a large number of<br />

epidemiology studies. The Advisory Committee<br />

on <strong>Pesticide</strong>s describes the system for the<br />

review of epidemiological studies carried out by<br />

its Medical and Toxicology Panel as one of the<br />

key measures in place to check for possible<br />

adverse effects once a pesticide has been<br />

approved 43 .<br />

At the root of failing risk assessment:<br />

inadequate toxicity testing<br />

Questions are now being asked in the most<br />

respected scientific journals about the<br />

effectiveness and relevance of toxicological<br />

tests on laboratory animals which form the<br />

basis of current regulatory safety assessment<br />

of chemicals including pesticides. For example,<br />

the science journal Nature, reporting a new<br />

initiative by the European Commission to<br />

develop alternatives to animal testing<br />

acknowledges the poor quality of most animal<br />

tests, that they are ‘wasteful and poorly<br />

predictive’, and are ‘stuck in a time warp.’ 44<br />

According to the report, Thomas Hartung,<br />

head of the European Centre for the Validation<br />

of Alternative Methods (ECVAM) in Italy said,<br />

‘toxicity tests that have been used for decades<br />

are simply bad science.’ Nature’s senior<br />

European correspondent Alison Abbott<br />

remarks that the experiments have ‘never<br />

undergone the rigours of validation that in vitro<br />

alternatives now face. Most animal tests overor<br />

under-estimate toxicity, or simply don’t<br />

mirror toxicity in humans very well.’<br />

The current system has not always detected<br />

the evidence scientists have discovered in<br />

ecological phenomena of the harmful effects of<br />

chemicals. The recent Prague Declaration on<br />

Endocrine Disruption 45 (Appendix 8), which<br />

over 200 scientists have signed, states that ‘the<br />

existing safety assessment framework for<br />

chemicals is ill-equipped to deal with endocrine<br />

disrupters. Testing does not account for the<br />

effects of simultaneous exposure to many<br />

chemicals and may lead to serious<br />

underestimations of risk … A fundamental<br />

element of chemical safety assessment is the<br />

assumption of a threshold dose below which<br />

there are no effects. This may not be tenable<br />

when dealing with endocrine disrupters,<br />

because certain hormonally active chemicals<br />

act in concert with natural hormones already<br />

present in exposed organisms. Thus even<br />

small amounts of chemicals may add to the<br />

overall effects, irrespective of thresholds that<br />

might exist for these chemicals in the absence<br />

of natural hormones. Additionally, due to<br />

limited sensitivity of established test methods,<br />

it is likely that effects are overlooked.’<br />

The RCEP concurs with the signatories of The<br />

Prague Declaration in advocating the<br />

development of new assays and screening<br />

methods which should ‘take advantage of<br />

modern technologies such as genomics,<br />

proteomics, bioinformatics and metabonomics’:<br />

‘the element of uncertainty inherent in using<br />

animal models might be reduced by the<br />

development of the new integrated and<br />

molecular based technologies, such as the use<br />

of toxicogenomic methods or human cell<br />

culture models and the development of animal<br />

models of multisymptom/multisystem disease.<br />

… Toxicogenomics is a tool in development,<br />

but it has the potential to inform and improve<br />

risk assessment in the future … Under strictly<br />

controlled experimental conditions, human cell<br />

culture models can be used to re-create<br />

human cellular function in an in vitro<br />

environment … This could reduce the need for<br />

animal models and animals for experimentation<br />

and deserves further exploration for those<br />

involved in pesticide regulation 46 .There is,<br />

however, considerable scientific disagreement<br />

on the how accurately different forms of testing<br />

can predict outcomes 47 .<br />

The relevance of animal data to human<br />

disease is questionable when considering the<br />

wide inter- and intra-species variability of just<br />

one toxicological endpoint, the lethal dose<br />

(Appendix 9). Data from the same species but<br />

the second <strong>UK</strong> pesticide exposure report 15

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