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England and Wales High Court (Administrative Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> Downs v Secretary of State for Environment, Food and Rural Affairs  EWHC 2666 (Admin) (14 November 2008)
Cite as:  JPL 885,  NPC 124,  Env LR 19,  EWHC 2666 (Admin)
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QUEEN'S BENCH DIVISION
Strand, London, WC2A 2LL
B e f o r e :
| Georgina Downs
|- and -
|Secretary of State for Environment, Food and Rural Affairs
Mr Robert Jay, Q.C. & Mr Vikram Sachdeva (instructed by The Treasury Solicitor) for the Defendant
Hearing dates: 15 18 July 2008
Crown Copyright ©
Mr Justice COLLINS :
"None of the government agencies involved with pesticides seem to have made any serious attempt to gather data on the chronic effects of pesticides on human health."
In 1990, the BMA published a Guide to Pesticides Chemicals and Health which, recognising that (at that time) most studies had been inconclusive in relation to the chronic effects of pesticides on human health, said:-
"public anxiety can no longer be allayed by merely stating that no harmful effects have been observed from a particular pesticide and therefore it is safe. Those responsible for the clearance of pesticides must convince the public that they have the resources, knowledge and independence of judgment to investigate potential risk to human health from pesticide use and they must do this more openly. "
The BMA advocated a precautionary approach which is now to be found in the Directive. It is to be noted that the European Commission in July 2006 in launching a new pesticide strategy stated that, while direct contact might occur during the time of application, indirect exposure was the most common form of contamination. It said:-
"Residents and bystanders can be indirectly exposed to pesticides via spraydrift . The effects of indirect exposure can be worse for especially vulnerable population groups such as children, the elderly or other particular risk groups (chronically sick people for instance).
Long term exposure to pesticides can lead to serious disturbances to the immune system, sexual disorders, cancers, sterility, birth defects, damage to the nervous system and genetic damage."
"Whereas the provisions governing authorisations must ensure a high standard of protection, which, in particular, must prevent the authorisation of plant protection products whose risks to health, groundwater and the environment and human and animal health should take priority over the objective of improving plant protection;
Whereas it is necessary at the time when plant protection products are authorised to make sure that, when properly applied for the propose intended, they are sufficiently effective and have no unacceptable effect on plants or plant products, no unacceptable influence on the environment in general and, in particular, no harmful effect on human or animal health or on groundwater."
Article 3, which deals with general provisions, requires that Member States must not permit the use of other than authorised pesticides. Article 3(3) provides:-
"Member States shall prescribe that plant protection products must be used properly. Proper use shall include compliance with the conditions established in accordance with Article 4 and specified on the labelling, and the application of principles of good plant protection practice as well as, whenever possible, the principles of integrated control."
'Integrated control' is defined in Article 2(.13) to mean:-
"the rational application of a combination of biological, biotechnological, chemical, cultural or plant-breeding measures whereby the use of chemical plant protection products is limited to the strict minimum necessary to maintain the pest population at levels below those causing economically unacceptable damage or loss."
"1. Member States shall ensure that a plant protection product is not authorised unless:
(a) its active substances are listed in Annex I and any conditions laid down therein are fulfilled, and, with regard to the following points (b), (c), (d) and (e), pursuant to the uniform principles provided for in Annex VI, unless:
(b) it is established, in the light of current scientific and technical knowledge and shown from appraisal of the dossier provided for in Annex III, that when used in accordance with Article 3(3), and having regard to all normal conditions under which it may be used and to the consequences of its use:
(i) it is sufficiently effective;
(ii) it has no unacceptable effect on, plants or plant products;
(iii) it does not cause unnecessary suffering and pain to vertebrates to be controlled;
(iv) it has no harmful effect on human or animal health, directly or indirectly (e.g. through drinking water, food or feed) or on groundwater;
(v) it has no unacceptable influence on the environment, having particular regard to the following considerations:
its fate and distribution in the environment, particularly contamination of water including drinking water and groundwater.
its impact on non-target species."
In the light of the arguments on the proper construction of this provision, it is worth noting (despite the general lack of need to refer to them) that the 2005 Regulations deal with it in Regulation 6, which sets out general requirements for granting what are called standard approvals (i.e. those resulting from submission of the necessary dossiers required by Annexes II and III of the Directive). Regulation 6(3) provides, so far as material:-
"Having regard to current scientific and technical knowledge and upon the appraisal of the dossier submitted for the approval of the product, it shall have been established (pursuant to the uniform principles provided for in Annex VI) that, when used "
it meets the requirements set out in Article 4(1)(b).
"In the light of current scientific and technical knowledge, an active substance shall be included in Annex I for an initial period not exceeding 10 years, if it may be expected that plant protection products containing the active substance will fulfil the following conditions:-
(a) their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, and the said residues, insofar as they are of toxicological or environmental significance, can be measured by methods in general use;
(b) their use, consequent on application consistent with good plant protection practice, does not have any harmful effects on human or animal health or any unacceptable influence on the environment as provided for in Article 4(1)(b)(iv) and (v). "
Article 7 requires that the holder of an authorisation must immediately notify the competent authority of all new information of any potentially dangerous effects of any plant protection product on human or animal health, groundwater or the environment. Article 11 enables a Member State to restrict or prohibit the use in its territory of a product which it has valid reasons to consider constitutes a risk to human or animal health or to the environment. All these provisions read with the two relevant recitals make it clear that if a pesticide is harmful to human health in its proper use it should not be authorised or used.
"For inclusion of an active substance in Annex I, the following shall be taken into particular account:
(a) where relevant, an acceptable daily intake (ADI) for man;
(b) an acceptable operator exposure level if necessary;
(c) where relevant, an estimation of its fate and distribution in the environment as well as its impact on non-target species."
It is recognised in this context that the adjective 'acceptable' in Article 5(2)(b) does not import any notion of a balancing exercise; it means that it does not exceed the level up to which there is no harmful effect. Furthermore, Article 5(4) permits inclusion in Annex I of an active substance subject to conditions on inter alia its use. Annex VI is, as will be seen, relevant since it sets out the principles to be applied by all Member States. These 'aim to ensure that evaluations and decisions with regard to authorisations result in the implementation of the requirements of Article 4(1)(b), (c), (d) and (e) of this Directive by all the Member States at the high level of protection of human and animal health and the environment': see Annex VI(A)(1).
"It should be commented that a study of 3 months in a rodent is equivalent to over 10% of the animal's lifespan (i.e. equivalent to 7 years in humans) and would involve dosing on every day."
Operators would be exposed on those days when spraying took place during the spraying season, bystanders or residents when the spraying took place over fields which would affect them. It is to be noted, as Mr Hamey records in Paragraph 19 of his first statement:-
"The guidance also makes clear that the general principle is that NOAELs for local effects such as skin irritation, eye irritation and skin sensitisation are not considered relevant to setting an AOEL. The risk of such effects should be addressed by hazard symptoms and risk and safety phrases on the product label."
That may be material for operators, but bystanders or residents will not be aware of such warnings. It appears that the Commission has since 2006 been considering two changes to the guidance. First, human data should not be used to support a higher AOEL than can be derived from animal data and secondly, definitions of bystanders and residents have been proposed. As far as I am aware, those amendments have not yet been put in place. The word 'bystander' is not on its face entirely appropriate for consideration of the risks to residents, who will be exposed far more regularly than those who happen to be near a field which is being or has recently been sprayed. However, the defendant accepts that the word 'bystanders' used in the Directive covers anyone who is not involved as an operator or as a worker (namely one who works in a field which has been sprayed and so is exposed to residues) and so includes residents. It is therefore recognised that their exposure must be properly considered and any harm to their health cannot be permitted. Any reference to 'bystanders' hereafter will include residents unless the context requires otherwise.
"the skin irritancy of the plant protection product must be determined except where it is likely, as indicated in the test guideline, that severe skin effects may be produced or that effects can be excluded."
Paragraph 7.2 deals with data on exposure. It covers 'operators, bystanders or workers'. 220.127.116.11 requires an estimation of operator exposure in all circumstances based on a suitable calculation model where available, based on assumptions of use and non-use of protective equipment respectively. 18.104.22.168 requires a measurement of operator exposure in the following circumstances:-
"Actual exposure data for the relevant exposure route(s) must be reported where the risk assessment indicates that a health-based limit value is exceeded. This will, for example, be the case when the results of the estimation of operator exposure provided for under Point 22.214.171.124 indicate that:-
- the AOEL(s) established in the context of inclusion of the active substance(s) in Annex I, and/or
- the Limit Values established for the active substance and/or toxicologically relevant compound(s) of the plant protection product [which relates to carcinogens]
may be exceeded.
Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under Point 126.96.36.199."
The Directive further provides that in cases where dermal exposure is the most important exposure route, a dermal absorption test (or the results of a sub-acute dermal study) may be a useful alternative test to provide data in order to refine the estimate of operator exposure.
Bystanders can be exposed during the application of plant protection products. Sufficient information and data must be reported to provide a basis for the selection of appropriate conditions of use, including the exclusion of bystanders from treatment areas and separation distances.
Aim of the estimation
An estimation shall be made, using where available a suitable calculation model in order to permit an evaluation of the bystander exposure likely to arise under the proposed conditions of use.
Circumstances in which required
An estimation of bystander exposure must always be completed.
An estimation of bystander exposure must be made for each type of application method. The estimation shall be made with the assumption that bystanders do not use any personal protective equipment.
Measurement of bystander exposure may be required when estimates indicate a cause for concern."
Operators are likely to be exposed to the concentrated and also to the dilute in the spraying exercise. Bystanders are likely to be exposed to the dilute in the form of spray, but it must be remembered that residents can be exposed to residues. While these may be small in quantitative terms, they will be residues of the active substance or substances which will not be in a dilute form.
"2.4 Impact on human or animal health
2.4.1 arising from the plant protection product
188.8.131.52 Member States shall evaluate operator exposure to the active substance and/or to toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions) using by preference realistic data on exposure and, if such data are not available, a suitable, validated calculation model.
(a) This evaluation will take into consideration the following information:(i) the toxicological and metabolism studies as provided for in Annex II and the results of the evaluation thereof including the acceptable operator exposure level (AOEL). The acceptable operator exposure level is the maximum amount of active substance to which the operator may be exposed without any adverse health effects. The AOEL is expressed as milligrams of the chemical per kilogram body weight of the operator. The AOEL is based on the highest level at which no adverse effect is observed in tests in the most sensitive relevant animal species or, if appropriate data are available, in humans:(ii) other relevant information on the active substances such as physical and chemical properties:(iii) the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies:(iv) other relevant information as provided for in Annex III such as:
- composition of the preparation
- nature of the preparation
- size, design and type of packaging
- field of use and nature of crop or target
- method of application including handling, loading and mixing of product
- exposure reduction measures recommended,
- protective clothing recommendations,
- maximum application rate,
- minimum spray application volume stated on the label,
- number and timing of applications;(b) this evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking account of mixing, loading operations, application of the plant protection product, and cleaning and routine maintenance of application equipment.
184.108.40.206 Member States shall evaluate the possibility of exposure of other humans (bystanders or workers exposed after the application of the plant protection product) or animals to the active substance and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use.
This evaluation will take into consideration the following information:
(i) the toxicological and metabolism studies on the active substance as provided for in Annex II and the results of the evaluation thereof, including the acceptable operator exposure level:(ii) the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies:(iii) other relevant information on the plant protection product as provided for in Annex II such as: re-entry periods, necessary waiting periods or other precautions to protect humans and animals,
- method of application, in particular spraying,
- maximum spray application volume,
- composition of the preparation,
- excess remaining on plants and plant products after treatment,
- further activities whereby workers are exposed.
2.4.2 Arising from residues
220.127.116.11 Member States shall evaluate the specific information on toxicology as provided for in Annex II and in particular:
- the determination of an acceptable daily intake (ADI),
- the identification of metabolites, degradation and reaction products in treated plants or plant products,
- behaviour of residues of the active substance and its metabolites from the time of application until harvest, or in the case of post-harvest uses, until outloading of stored plant products."
"2.4 Impact on human or animal health
2.4.1. arising from the plant protection product
18.104.22.168. No authorisation shall be granted if the extent of operator exposure in handling and using the plant protection product under the proposed conditions of use, including dose and application method, exceeds the AOEL.
22.214.171.124. Where the proposed conditions of use require use of items of protective clothing and equipment, no authorisation shall be granted unless those items are effective and in accordance with the relevant Community provisions and are readily obtainable by the user and unless it is feasible to use them under the circumstances of use of the plant protection product, taking into account climatic conditions in particular.
126.96.36.199. Plant protection products which because of particular properties or if mishandled or misused could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distribution, use or manner of use. Moreover, plant protection products which are classified as very toxic may not be authorised for use by non-professional users.
188.8.131.52. Waiting and re-entry safety periods or other precautions must be such that the exposure of bystanders or workers exposed after the application of the plant protection product does not exceed the AOEL levels established for the active substance or toxicologically relevant compound(s) in the plant protection product nor any limit values established for those compounds in accordance with the Community provisions referred to in point 184.108.40.206."
"According to the ninth recital in the preamble to that Directive, those procedures [i.e. uniform procedures for authorisation of pesticides] are to ensure a high standard of protection which, in particular, must prevent the authorisation of plant protection products whose risks to health, groundwater and the environment have not been appropriately investigated; moreover, the protection of human and animal health and the environment should take priority over the objective of improving plant production. The tenth recital adds that it is necessary to make sure that the products in question 'have no unacceptable influence on the environment in general and, in particular, no harmful effect on human or animal health or on groundwater."
In Paragraph 26, the court identifies Article 4(1) as the source of the rules for authorization. The court thus links Annex VI to Article 4(1) for the purpose of authorization. But it seems clear to me that authorization may be appropriate subject to conditions or limitations on use which are needed to protect the health of bystanders or residents. Otherwise the fundamental concern of the Directive as identified in Recitals 9 and 10 that human health must not be harmed would not be met. Point A7.2.2 of Annex III, which deals with authorization, requires that bystanders need to be protected by imposing appropriate conditions of use. As it seems to me, those conditions may be specific to a particular authorization or general and so apply to all authorizations. Mr Jay submitted that compliance with Article VI was sufficient for the purposes of the Directive. That would only be so provided that the compliance adequately covered the risks to bystanders and residents.
"It follows from that provision (viz: Article 5(1) applying Article 4(1)(b)(iv) and (v)), interpreted in combination with the precautionary principle, that, in the domain of human health, the existence of solid evidence which, while not resolving scientific uncertainty, may reasonably raise doubts as to the safety of a substance, justifies, in principle, the refusal to include that substance in Annex I The precautionary principle is designed to prevent potential risks. By contrast, purely hypothetical risks, based on mere hypotheses that have not been scientifically confirmed, cannot be accepted. "
And in Paragraph 170 the court stated, having regard to Article 5(4):-
" [B]efore including a substance in Annex I to that Directive, it must be established beyond a reasonable doubt that the restrictions on the use of the substance involved make it possible to ensure that use of that substance will be in accordance with the requirements laid down in Article 5(1) of the Directive 91/414."
The court found that the necessary solid evidence was provided by a Guatemalan study which showed that one of the operators taking part had suffered exposure to paraquat equal to 118% of the AOEL.
" 'bodily harm' has its ordinary meaning and includes any hurt or injury calculated to interfere with the health or comfort of the prosecutor. Such hurt or injury need not be permanent, but must, no doubt, be more than merely transient and trifling. "
Those sentences were cited in the House of Lords in R v Brown  2 All ER 75 (see for example per Lord Templeman at p.78d) and no disapproval was indicated. Counsel on both sides accepted that any harm to human health which could properly be regarded as more than merely transient or trifling must be avoided if the Directive is to be complied with. I shall return to this in considering Ground 2 of the claim. Its importance lies in a recognition that local effects, for example a headache, skin or eye irritation, a sore throat and other such non-permanent reactions can constitute harm.
"But its only when we bring together the information about the hazard (about whether the chemical is toxic and in what way it is toxic), its only when we bring that together with the exposure (the route of exposure, the frequency of the exposure, the amount of exposure and the duration of exposure) that we can hope to assess what the risk to the health of the individual is."
All exposure factors must, it is said, be taken into account. It is not enough to consider exposure to the immediate spray alone. There must be recognition that residents may be exposed to vapours which persist in the air for a considerable time (certainly hours and possibly days, weeks or even longer) and to residues which may, for example, be contained in harvest dust or may have settled in gardens or within houses. Exposure may occur by various routes. These will include inhalation, through the skin, eyes or mouth (for example, if a child plays in a garden and sucks a toy which has been exposed to spray). And such exposure may occur throughout each year over a number of years.
"3.39 The standard exposure assessment used by the PSD represents a pragmatic approach to a complicated problem. Given the assumptions of an unclothed bystander, high breathing rate, proximity to the boom, the uncertainty factor of 100 that has been used in calculating the AOEL from animal toxicology data, and with some account being taken of repeated exposure, the assessment is probably conservative and protective in the majority of situations. However, the assessment only accounts for exposure through spray drift and essentially ignores the complex phenomena governing it. There is no indication, for example, that the well-regarded research on spray drift that has taken place over many years at the Silsoe Research Institute, funded by the Department for Environment, Food and Rural Affairs (Defra), has been used to evaluate the validity of the approach used and assumptions made, or to develop the approach further. As a result, the PSD approach, defined by the standard formula (box 3A), suffers from the following serious shortcomings:
- It is based on a gross simplification of real exposure and it does not address all of the possible exposure routes. It is based on single-valued parameters from a limited set of experiments and does not attempt to represent the physical mechanisms that determine the extent of exposure and takes little account of the variability of dispersion conditions encountered in practice;
- It explicitly takes into account only exposure by spray drift at the time of spraying by bystanders in the narrow sense, as defined in 1.19, (though the additional papers, ACP9(297/2003) and ACP20(301/2003), contained preliminary estimates of some other exposures to residents and others including inhalation of vapours and ingestion of soil);
- It is based on very limited data obtained in the 1980s, since when, farm practices have changed significantly; for example tractors are capable of significantly faster speeds, boom sizes have increased, formulations have changed and the concentrations and flow rates used are often different;
- It assumes good operational practice; for example spraying only in recommended weather conditions (although high wind speeds were recorded during some trials) and at moderate vehicle speeds;
- Average values from the 1980s trials were used to estimate the PDE and PIE, with no account take of the large variability due to turbulence in the atmospheric boundary or of the dependence of drift on wind speed (3.12, figure 3-VI);
- It does not taken into account the important vertical variation in the profiles of spray drift (figure 3-VII) and their change with distance and wind speed (figure 3-VI);
- Though a separate risk assessment is undertaken for re-entry to the sprayed field and subsequent contact with treated foliage, which can be extended to individuals walking within a recently sprayed field, the standard formula does not include this route of exposure or risk assessment; and
- No account is taken of the possible importance for airflows and therefore spray drift, of topographic features such as sloping, or irregular ground and also the effect they have on boom height, particularly if the tractor is driving at higher speeds.
3.40 Overall, we believe the PSD approach, even after its re-evaluation in 2003 which resulted in no change to the formula, is best described as yielding an approximate exposure estimate based on data which happened to be available, rather than a scientific prediction validated systematically by specifically designed experiments. Full details of the experimental conditions for the original 1983 and 1987 trials are not given and the approach has not been validated by the kind of peer review necessary for publication in the open scientific literature."
While it indicates that 'the assessment is probably conservative and protective in the majority of situations', it identifies what it regards as serious shortcomings. In considering its July 2003 discussion paper, the ACP had concluded that the examples used were appropriate and could be identified as worst case scenarios and that, with one possible exception relating to soil fumigants, the approach taken to assess bystander risks was generally protective. The RCEP commented:-
"3.44 We consider that the present approach may be conservative and protective in its treatment of targets but in view of the absence of any attempt to model the complexity of bystander exposure and the probability of extreme values, we cannot agree that this has been conclusively or transparently demonstrated for the exposure process. We cannot therefore support the ACP's unequivocal conclusion above."
"We've taken a stab because we don't have from the original arable spraying report the exact durations that the spraying operation took."
Nonetheless, he stated that it was a conservative assessment. In addition, it is said that it failed to take into account that there would be likely to be a mixture of active substances in any particular pesticide product and that in addition crop spraying applications commonly spray mixtures of different products in any one application. The claimant draws attention to observations made by Professor Coggon, Chairman of the ACP, at the July 2002 open meeting suggesting further studies including the setting of monitors at the edge of a garden adjacent to a field being sprayed to get a measure of actual exposure levels. No such further studies have taken place.
"Although [this paper] does suggest the current approach is protective, it is not transparently so. A new more transparent approach could be developed based on these examples."
The claimant complains that there has not been any change to the current approach.
"It is a crude model, but the indications are, supported by empirical data, that the major determinant of exposure for a bystander for almost all pesticides is going to be if they are very close to a sprayer when it goes past. That exposure occurs from inhalation of droplets and from dermal deposition of droplets and skin absorption."
He then referred to other possible exposure routes and to children 'crawling around on the ground which is adjacent to land which is being sprayed'. He reiterated that the major determinant of individual exposure was to an individual who was very close to a sprayer when it went past. He concluded:-
"If you base your risk assessment on the exposure that could occur if somebody was next to a sprayer when it was going past, and particularly when you are assuming that that can occur on every day of the spraying season and not on just one day, then I think you have a very conservative method of assessing exposures for risk assessment."
He confirmed that by 'next to' and 'very close' he was referring to the 8 metre tests: but he said, in relation to the 1 metre test carried out subsequently, 'when you go up 1 metre you do not increase the exposure by that much'. The claimant says that up to 8 times is hardly not much.
"Taking this into account, together with potentially relevant variables such as those identified by the RCEP, and also the potential for exposure from sources other than direct contact with spray drift, our assessment is that the current exposure model is extremely unlikely to underestimate the maximum 24 hour exposure of any bystander by as much as a factor of 10, and that exposures above those currently estimated, if they occur at all, will be rare. Apart from anything else, it would be very unusual for a bystander to stand within one metre of a passing spray boom. Most people would stand back from moving agricultural machinery (because of the risk of physical trauma), and most farmers would have the good sense and manners not to spray right next to a member of the public when there was no intervening barrier such as a hedge."
The claimant makes the point that the last sentence does not reflect the real situation. So far as good manners is concerned, she placed models in her garden which appeared to be humans and (assuming that the operator was unaware they were only models) spraying took place right up to the boundary.
"Whether as dusts, spray mist, or fumes, pesticides can be drawn into your lungs as you breathe. Inhalation of pesticides can occur during the mixing of wettable powders, dusts, or granules. Poisoning can also occur while fumigating or spraying without a self contained breathing apparatus or a proper respirator in enclosed or poorly ventilated areas such as greenhouses, apartments, or grain bins. The largest particles that are inhaled tend to stay on the surface of the throat and nasal passages, and do not enter the lungs. Smaller particles can be inhaled directly into the lungs. The number of particles needed to poison by inhalation depends upon the concentration of the chemical in the particles. Even inhalation of dilute pesticides can result in poisoning. Once they are absorbed through the surfaces of the lungs, chemicals enter the blood stream and are distributed to the rest of the body."
The claimant further says that it is apparent from studies that low volatility pesticides tend to accumulate on the soil surface. As water evaporates, volatilisation increases with time, a point which has not, she avers, been considered by the defendant.
"The repeated use of pesticides, even in small quantities, can have cumulative effects which may not be noticed until a dangerous amount has been absorbed. "
"The guidance also makes it clear that the general principle is that NOAELs for local effects such as skin irritation, eye irritation and skin sensitisation are not considered relevant to setting an AOEL. The risk of such effects should be addressed by hazard symbols and risk and safety phrases on the product label."
"The scientific judgment is not immune from lawyers' analysis. But the court must be careful not to substitute its own inexpert view of the science for a tenable expert opinion."
|There are clinical symptoms and signs typical of exposure to the cited pesticide formulation combined with either: corroborating medical and (where appropriate) biochemical evidence; or evidence of overexposure
|The balance of evidence based on reported exposure circumstances, clinical symptoms and signs or biochemical evidence (where appropriate) is consistent with ill health due to exposure to the cited pesticide formulation
|(i) the reported ill health is not consistent with the known potential ill-health effects of the cited pesticide formulation given the reported exposure circumstances but the implied association cannot be entirely discounted in the light of current knowledge; or
|(ii) the evidence is consistent with pesticide exposure being the cause of the reported ill-health but alternative explanations, e.g. pre-existing disease, are also present
|There is strong evidence, e.g. evidence about exposure or from medical reports, that the reported ill health is not pesticide-related
|The available data are insufficient, incomplete or conflicting and the panel is unable to classify a case for one or more of these reasons.
"37. As in most previous years, the majority of people were assessed as having 'mild' symptoms (13 classified as local, two as systemic) while the remainder (11) were assessed as having 'moderate local' symptoms. No one was considered by the panel to have suffered from 'moderate systemic' or 'severe' symptoms.
38. Mild local symptoms are most commonly a self-limiting skin rash or an irritation of the skin, eyes or respiratory tract, while mild systemic symptoms include transient headaches and nausea. Seven of the individuals with moderate symptoms were from the 'confirmed' incident who attended the local hospital Accident and Emergency Department complaining of respiratory and eye irritation while the four others attended their general practitioner, two with a persistent shortness of breath and two with persisting skin rash."
The seven individuals in the incident referred to were railway workers who were exposed while working on the line next to a field being sprayed with a herbicide.
"74. There is also another example in volume one that is before the court of Paul Hamey clearly confirming the acute effects of pesticides in residents and bystanders, (again that would include 'local' effects, such as irritancy), as the following quotes are taken from the transcript of the meeting I had with then DEFRA Ministers Lord Whitty and Michael Meacher on December 17th 2002, in which Paul Hamey was also in attendance. One of the Minsters, Michael Meacher, asked Mr Hamey to clarify how, as the public authority, the PSD could assert that residents (and bystanders) are protected by the current approach. In response, Mr Hamey quite clearly and tellingly stated that:
" the Health and Safety Executive do investigate cases where there is evidence of ill-health effects and they will go and look at the spray records and they will look at the toxicology information and to see whether the alleged effects are likely to be related to the pesticide exposure or not and to be fair there are about 10 or 12 cases a year when they say yes there is some relationship to the pesticide use when bystanders reported ill effects and most of those effects or nearly all, all of those effects they report are, are acute effects, not long-term effects, um, and there might, there might be issues and arguments. I'm sure Georgina would make, about how representative sampled are actually reported to HSE, but, so there is to be fair some evidence that there are a small number of cases that are related".
75. Michael Meacher then asked Mr Hamey to explain that if there is this "huge safety margin written in", then how is that "remotely compatible with these effects".
76. Paul Hamey again responded by just referring to the incidents that are confirmed by PIAP as he stated " it's the same as for workers that are using the pesticides, I mean there are a number of incidents a year, a small number, that are confirmed by the er, Pesticides Incident Appraisal Panel as being likely to be due to exposure to the pesticide.
77. Michael Meacher said in response "but that makes the argument, that in fact pesticides will cause these effects and the only cases that come to light is where people report it, there are probably hundreds of people who don't report it.
78. Therefore the aforementioned comments by Paul Hamey completely contradict what he has subsequently said in his witness statement, that any risk of acute local effects, is only expected to apply to operators handling the concentrated product and not to those exposed to the dilute spray from crop-spraying."
The then minister's reaction is of considerable interest.
"48. Directive 91/414/EEC is clear that authorization is not permitted if exposures are over the AOEL. This is the standard that the UK applies, and in the light of the best knowledge this should avoid serious effects on health. However local effects are not considered when setting the AOEL. Rather, the approach set out under Directive 91/414/EEC to managing these risks, which are primarily faced by the operators (i.e. users), is through classification and labelling. Therefore plant protection products which may present risks of local effects such as irritation or sensitisation are permitted to be authorised, but are classified and labelled to alert users of the risk(s) with recommendations for personal protective equipment to be worn.
49. There may be a small risk that operators experience local effects. However, the spray solutions are unlikely to be irritating or sensitising because normally products are diluted to less than 1% (irritants or sensitizers diluted to less than 20% and 1% respectively are below the cut-off for classification for such effects). Thus, any risk is related to handling the concentrated product and is not expected to apply to bystanders, who are only exposed to diluted spray solution.
50. The ACP's statement about serious illness is a recognition of the limitation of the risk management approach for local sensitisation effects in operators. However, the approach adopted by the PSD for local effects is entirely consistent with the Directive 91/414/EEC in that risks of local effects are managed through the classification and labelling since the risk arises from the concentrate not the diluted spray and in particular the risk applies to users handling the concentrate."
" Spraying from vehicles without cabs may result in a high level of exposure through your skin or by breathing in the spray. You should take care to keep your exposure to spray drift as low as possible and you must wear appropriate PPE (possibly as well as that specified in the product label."
This correctly recognises that there is a risk from the diluted pesticide when spraying takes place.
" no-one should be harmed or made ill by the presence of pesticide residues in food or drink."
This certainly appears to differentiate between harm caused through use which must involve serious illness and harm caused through residues in food or drink which is not qualified. However, in a joint memorandum presented to an inquiry by the Environment, Food and Rural Affairs Committee on 20 October 2004 by Defra and HM Treasury, this is said in Paragraph 4:-
"The first component of pesticide policy is that the statutory system of regulating pesticides places controls on their marketing the (sic) use in order for there to be should be (sic) no unacceptable risks to people's health or to the environment. The term 'unacceptable risk' has slightly different meaning for health effects and for environmental effects. If there is scientific evidence that use of a pesticide may harm human health, that is considered unacceptable."
That is a correct approach, as Mr Jay submits. In an article published in April 2006, Professor Coggon said this:-
"A major aim of pesticide regulation is that no-one should be made seriously ill through toxic effects of pesticides when they are used in accordance with the conditions of their approval. Ideally, there would be no adverse effects whatsoever, but achieving this would lead to major inconsistencies with other areas of risk management. For example, it would be unreasonable to ban a product because it caused occasional skin sensitisation in operators, when occupational exposure to other, more potent skin sensitizers such as epoxy adhesives is permitted. Similarly, unpleasant smells and minor and transient eye irritation may be tolerated, as they are when produced by, for example, the occasional bonfire. Nevertheless, regulatory controls on pesticides are more stringent than for almost all other industrial products."
The use of the adverb 'seriously' is unfortunate, but the examples being given are likely to be categorised as merely transient and trifling. It is worth noting that in that same article, in which he commented on the disagreement between the ACP and the RCEP, he says that 'poisoning by spray drift rarely occurs, and seldom if ever is of sufficient severity to warrant hospital admission'. He concludes:-
"The ACP consider that these checks add to the reassurance that regulatory current controls provide appropriate protection for bystanders."
"As Professor Coggon has explained, in residents and bystanders a 'serious' adverse effect is anything other than transient minor irritant symptoms (of the same sort that might be produced when visiting the local swimming pool). Discomfort associated with unpleasant odours would not be considered serious. In workers and operators, a small risk of skin sensitisation may be considered acceptable."
"5.2.4 the skin irritancy of the active substance must be determined except where it is likely, as indicated in the test guideline, that severe skin effects may be produced or that effects can be excluded.
5.2.5 Eye irritation tests must be conducted except where it is likely, as indicated in the test guideline, that severe effects on the eyes may be produced."
There are analogous paragraphs (7.1.4 and 7.1.5) in Annex IIIA. Mr Jay submits that this shows that effects which are less than severe are outside the scope of paragraph 7.2.1 of Annex IIIA. That is to misconstrue the provisions. What is being said is that skin irritancy must be determined except where the test guidelines show that severe effects or no effect may result. The provision in relation to eyes, no doubt because of the greater effect of any damage to them, requires determination unless serious effects may be produced. Thus what is required is a determination when there may be an effect which is less than severe. It does not imply that anything less than severe can be disregarded. The contrary is the case.
"As a general principle, NOAELs for local effects are not considered relevant to setting an AOEL, since they often correlate closely with the concentration of the substance at the site of contact. However, it may not always be possible to be certain whether a possible systemic effect is secondary to a local effect. If there is doubt, the possible systemic effect should be regarded as relevant for setting an AOEL. In general, local effects as (sic) skin irritation, eye irritation and skin sensitisation should be addressed by hazard symbols and risk and safety phrases on the product label, and appropriate risk management (e.g. suitable PPE or engineering controls) should be considered in order to minimise exposure."
This leads to the submission that Article 4 does not impose an overriding requirement but that application of the uniform principles in Annex VI, which involve reference to an AOEL, will suffice. Since local effects are not taken into account in assessing an AOEL, they need not be taken into account in deciding on whether an authorisation should be granted or the appropriate conditions which should be attached.
"I have now completed a detailed consideration of the outcome of two consultation exercises regarding the introduction of buffer zones and information on pesticide use. As a result I would like to announce a number of measures designed to provide additional reassurance about the pesticide regulatory process and to improve public access to information about pesticides used."
He said that the 'independent scientific advice' he had received both from the independent ACP and Defra's chief scientific advisor was very clear that the existing system provided full reassurance. Thus he saw no reason to introduce buffer zones. He continued:-
"Nevertheless the responses to the consultations demonstrated that there is a perception that the current arrangements, and in particular the assessment of risks are inadequate. I have listened to the concerns of campaigners who hold strong views about how crop spraying has affected their health. Their views are undoubtedly sincerely held and although no new scientific evidence was produced to support their case, I believe that the time is now right for a fresh and independent appraisal of the science."
He also said he would set up a pilot study to explore how residents living next to farms could be notified in advance of pesticide use. Nothing seems to have come of this save for a reliance on dialogue between residents and farmers. That has not in the experience of the claimant, who has made it her business to discover whether there has been the giving of necessary information, been in the least effective. The delivery by the NFU of leaflets on one occasion to farmers has not achieved anything positive.
"3.50 We have serious concerns about the current method of assessing resident and bystander exposure to pesticides. Although uncertainty factors are built into the AOEL, they are there to cover issues related to toxicology and do not address the variability of exposure or the uncertainties in exposure assessment.
3.51 We have also been disappointed to find that the current approach has not been rigorously evaluated under field conditions and has largely been assessed in relation to experiments done on a limited scale over twenty years ago and reassessed on the basis of other data often collected for different purposes in Germany and the US. The current approach does not take account of the range of possible factors that influence the probability of high exposures. It is important that new field testing is performed and that it should take account of variations in conditions such as boom height, wind speed and tractor speed so as to provide a sensitivity analysis. This will enable legislators and operators to have a better understanding of which variables are really important and how significant an impact they can make.
3.52 Neither does the current approach reflect the probabilistic nature of exposure of residents or bystanders to pesticides. In reality, extent to which there is a problem will be determined by the probability of high resident and bystander exposure to a particular pesticide, together with the probability that this resident or bystander is sufficiently sensitive to that pesticide to be affected by such an exposure.
3.53 We recommend that the current approach for assessing resident and bystander exposure should with some urgency, be replaced by a computational model which is probabilistic, looks at a wider range of possible exposure routes and more robustly reflects worse-case outcomes. The model should be rigorously validated by wind tunnel and field tests designed for the purpose, including non-standard conditions to test the sensitivity of the model predictions. As a first step, whoever takes ownership of the creation of relevant data should undertake a thorough review of the relevant experimental work that already exists.
3.54 We recommend that validation of the model should be supported by monitoring of representative pesticides in a range of field situations. Such monitoring should include measurements of concentrations in air for extended periods after spraying to contribute to better understanding of possible exposure other than through immediate spray drift.
3.55 We recommend that both the model and the test data be peer reviewed and published in the open scientific literature so that the basis for the predictions is transparent and can be evaluated. Without this, there can be no expectation of confidence in the predictions.
3.56 In the short term, whilst the new probabilistic model is being developed and introduced, we recommend that all actual spraying practice be brought into line with the aspirations of the Green Code recommendations including giving proper regard to the importance of optimal timing of the application and therefore efficacy of the pesticide. This will require appropriate monitoring arrangements and sanctions for non-compliance. These short-term practical measures must contain provisions for recording relevant data."
"Overall while there is a need for further empirical data to confirm the adequacy of the current approach to bystander risk assessment, there is no indication of a problem from the data that are currently available."
"On balance we favour a simpler approach of the type that is currently employed, provided that it is demonstrably conservative and clearly gives consideration to all potential sources of exposure (if only to dismiss those sources that can be shown to be of no importance). We do, however, see merit in further developing the scientific information base for bystander (and other) exposure modelling and as part of this, probabilistic techniques may be useful in characterising better some determinants of exposure."
Then it recognised there was a need for some further and better means of obtaining the necessary information for ensuring that 'bystanders' were properly protected.
"116. The Government recognises that notification can assist residents to make informed decisions regarding their behaviour in relation to pesticide spraying, should they wish to do so.
117. The Government considers that where a resident expresses concern about a farmer's use of pesticides it is good practice to give information about the pesticide and the reason for using it. It is also good practice to tell people who occupy land, premises or houses close to the area being sprayed. This is reflected in the guidance within the PPP Code.
118. A pilot study on prior notification was announced in 2004 by Alun Michael the then Minister for Rural Affairs and Local Environment Quality. The results of this study indicated that when residents' awareness had been raised through an introductory letter 75% expressed an interest in notification of spraying and that this dropped to 8% when some action was required on their part, for example a phone call, to obtain such information. Based on these findings there is no economic justification for requiring all adjacent residents to be notified in advance of all spraying events relative to a more targeted local approach. Provision of information does not guarantee any precautionary action will be taken by the recipient, Government would need to take other measures to ensure any health risks were addressed and therefore, the need for full notification can not be justified as a protective measure.
119. Application of pesticides in accordance with best practice and greatest efficacy requires quite specific weather conditions which can change rapidly on a day-to-day or even an hour by hour basis meaning that planned spraying is often cancelled or the decision is made at the last-minute. If a resident is notified in advance of spraying there is a risk that they may decide to take action as a result of this notification but that the spraying itself may be cancelled. This could lead to residents taking action on many more occasions than necessary. Similarly having made the effort to notify residents there is a risk that a farmer may feel constrained to spray in less than optimum conditions reducing the efficacy of the pesticide and potentially needing to increase the overall amount of pesticides used.
120. The Government believes that the above situations are best addressed through dialogue between the farmer and a resident so that both parties can understand the implications of notification, can consider alternative approaches which may satisfy the resident's concerns and if the resident would still like to be notified identity the most suitable means and timing of doing this.
121. The Government believes that making prior notification to all residents of every spraying event a statutory requirement would be highly bureaucratic and potentially reduce the ability of farmers to engage in such local best practice. The Government is committed to working with the various organisations representing the full range of stakeholders to identify how greater dialogue between farmers and residents can be encouraged and to develop ways in which farmers can be supported in providing information to residents. We will also examine the language in the PPP Code to determine if this can be amended to further encourage such local best practice."
"The court considers that Italy cannot be said to have 'interfered' with the applicants' private or family life; they complained not of an act by the State but of its failure to act. However, although the object of Article 8 is essentially that of protecting the individual against arbitrary interference by the public authorities, it does not merely compel the State to abstain from such interference, in addition to this primarily negative undertaking, there may be positive obligations inherent in effective respect for private or family life.
In the present case it need only be ascertained whether the national authorities took the necessary steps to ensure effective protection of the applicants' right to respect for their private and family life as guaranteed by Article 8 (see: Lopez Ostra v Spain)."
One of the obligations in question was to give necessary information to the inhabitants 'to enable them to assess the risks they and their families might run if they continued to live at Manfredoma, a town particularly exposed to danger in the event of an accident at the factory'. While no doubt such information was needed, it is difficult to see what practical steps those inhabitants could take. If the risk persuaded them it was necessary to move away, their houses would have a very much reduced value. I suppose they might have been able to take some legal action.