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You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> Downs v Secretary of State for Environment, Food and Rural Affairs [2008] EWHC 2666 (Admin) (14 November 2008)
Cite as: [2009] Env LR 19, [2009] JPL 885, [2008] EWHC 2666 (Admin), [2008] NPC 124

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Neutral Citation Number: [2008] EWHC 2666 (Admin)
Case No: CO/4483/2004


Royal Courts of Justice
Strand, London, WC2A 2LL
14 November 2008

B e f o r e :

Mr Justice COLLINS

Georgina Downs
- and -

Secretary of State for Environment, Food and Rural Affairs


Mr Michael Fordham, Q.C. & Ms Emma Dixon (instructed by Foresters for the Claimant
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 :

  1. The claimant, Ms Georgina Downs, has for a number of years been a campaigner who has sought to persuade the public authorities concerned and in particular the defendant and his predecessors to take the public health and environmental concerns raised by crop-spraying seriously. She has developed a very considerable expertise in and knowledge of pesticides and their application by means of crop-spraying and is listened to with respect by those who are responsible for giving relevant advice to the defendant. She has been nominated for and has won awards for her campaigning activities. She has been accustomed to presenting her arguments, which involve detailed scientific considerations and reference to facts and figures, often complicated, to support them. Thus she has produced in this claim three very detailed statements which set out the factual basis for the arguments presented on her behalf and which seek to meet the contrary arguments put forward on behalf of the defendant. She also asked and was permitted to read a statement at the outset of the hearing summarising her personal concerns and the basis of her claim. She can rest assured, as I have no doubt she realised as she listened to the arguments at the hearing, that those representing her put forward all the arguments in a most competent and persuasive fashion. Mr Fordham, Q.C., demonstrated full knowledge and understanding of the complex issues involved. Having said that, I should also record that Mr Jay, Q.C., on behalf of the defendant, displayed a similar understanding of the details of his case. I am indebted to both counsel for their assistance.
  2. Ms Downs' activities stem from her exposure to crop spraying as a person living next to fields which have been regularly sprayed for a number of years. She moved with her parents to her present address in May 1983 and since 1984 the adjoining fields have been used for arable crops and have been sprayed with pesticides. The garden of the claimant's house is immediately bordering the adjacent field with no protection from the spray which, since the field has always been sprayed to its edge, has inevitably drifted over the garden and entered the house via windows or doors if open, or through air vents. She was only 11 years old when first exposed to pesticide spraying and was frequently in the garden when it occurred. She began to suffer from ill-health, in particular flu like symptoms, sore throats, blistering in the mouth and throat and other problems. Neither she nor her parents nor her doctors realised for a time that it was possible that the exposure to pesticides could have caused her problems. In the early 1990s following deterioration of her health and an admission to hospital she began to seek information since she thought the crop spraying could account for her health problems. She discovered that the spray contained a number of chemicals which were designed to kill living organisms, whether animal (particularly insects) or vegetable (including fungi). The safety data sheets for pesticides contain warnings of the hazards to humans, some more serious than others. But warnings such as 'toxic by inhalation', 'do not breathe spray', 'toxic in contact with skin', 'risk of damage to eyes' are regularly found.
  3. This led to the family closing windows when spraying was taking place and for some days after since the chemicals were noticeable after spraying. Attempts to obtain advance notice that spraying was to take place were not generally successful. Following an occasion in 1998 when he was exposed to spray which affected his eyes, the claimant's father took to wearing protective clothing and goggles if going outside when spraying was taking place. The adverse effect on her and her father's quality of life is all too obvious. And, in addition to the drifting spray, at harvest time there is inevitably frequent dust which itself is contaminated with pesticide residue and this adds to the problem. Blood and fat tests have shown, according to her doctor, traces of pesticides in her blood and body fat to an extent which is abnormal.
  4. This claim was originally lodged by the claimant acting in person in September 2004. The decision then under attack was the refusal by the defendant "to apply mandatory no-spray buffer zones around agricultural land to protect rural residents from use of pesticides by farmers". The defendant had, on 16 June 2004, requested the Royal Commission on Environmental Pollution (RCEP) to carry out a special study to examine the scientific evidence on which DEFRA had based its decisions on the risks to people from pesticide exposure. This followed evaluation of responses to two public consultations launched in July 2003 which sought views on the introduction of buffer zones around residential properties near farms and how residents could best be informed of the pesticides that were being sprayed. Four broad topics were to be covered by the RCEP: these were health dimension, scientific modelling, legal and policy issues and public concerns. The minister stated that, although the scientific advice given to him was 'very clear that the existing system provides full reassurance' in relation to public health, he recognised that there was a perception that current arrangements were inadequate. Thus a fresh and independent approach was needed. It was sensibly decided that the claim should be adjourned pending the RCEP report and DEFRA's response.
  5. The RCEP reported in September 2005. It made a large number of recommendations, the most significant of which were that since in its view there could be a link between the exposure of residents and bystanders to pesticides and chronic ill-health, (acute effects being an accepted cause), a more precautionary approach should be taken and the current approach for assessing resident and bystander exposure should with some urgency be reflected by a different model. Further, it recommended the introduction of buffer zones, initially of 5 metres, that the recommended conditions in the Code of Practice should become statutory duties and that residents should be given prior notification of proposed spraying and should be entitled to know what pesticides were being used. On 30 December 2005 the Advisory Committee on Pesticides (ACP) produced a commentary published on 6 February 2006, which rejected those and the majority of the RCEP's recommendations. The ACP is the body which advises the defendant in relation to the authorization and use of pesticides and the measures needed to ensure the proper use of pesticides and the protection of public health. Following a response by the RCEP to the ACP's commentary, DEFRA responded on 20 July 2006. Essentially, it was decided that no further measures were needed so that the recommendations made by the RCEP were rejected.
  6. On 20 October 2006 the claim was amended (counsel by then having been instructed). It seems that the decision under attack, namely the refusal to implement a no-spray buffer zone, was not formally changed, but the claim before me was against the alleged failure by the defendant to comply with the obligations imposed by the relevant E.C. Directive (91/414/EEC) in that the domestic regime did not provide for the necessary protection of public health, in particular the health of those such as the claimant who were residents living near fields which were subjected to crop spraying. Three grounds were relied on. First, it was argued that there was no risk assessment capable of identifying and properly guarding against the effect on residents as opposed to those who might happen at the particular time to be near the field, properly described as bystanders. Secondly, the approach adopted by the defendant that there should be no serious harm to human health was wrong in law: the Directive did not qualify the requirement that the use of pesticides should not result in harm to human health. Thirdly, it was said that the defendant's failure to act on the RCEP's conclusion that a more precautionary approach was needed was erroneous and that at the very least cogent and clear reasons were needed to justify such a failure. There was included a submission that the failure meant that there was a breach of Article 8 of the ECHR in that the interference with the claimant's private life was disproportionate and not justified by Article 8(2).
  7. Concern about the possible effects on human health resulting from exposure to pesticides is nothing new. In 1951 a working party chaired by Professor S Zuckerman produced a report resulting from concerns about the safety of agricultural workers exposed to toxic chemicals. It made a number of recommendations, including that warning notices should be placed on gates giving access to fields that were being or had recently been sprayed, that spraying should not take place in windy conditions and that local doctors and hospitals should be notified when spraying was to be undertaken on farms in their locality and told what chemicals were to be used. In 1987, a report of the House of Commons Agricultural Committee expressed concern that:
  8. "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."
  9. Since this claim largely depends on whether there has been a proper application of the Directive, I should consider the relevant law which is applicable. The Directive has been applied domestically by the Plant Protection Products Regulations 2005 (SI 2005 No.1435). Since these reproduce the language of the Directive and import the Directive annexes, it is not subject to one exception which I refer to later in this judgment necessary to refer to them. Counsel have presented the arguments on the basis of the Directive and I shall do the same. The Claimant is concerned that the Directive is not being properly applied in that the risks to human health and associated harm, in particular for residents living near fields which are sprayed, has not been properly considered or protected in accordance with the requirements of the Directive.
  10. The Directive requires that no active substance in a plant protection product (this is the correct term: I shall continue to refer to such products as pesticides) can be used within the Community unless it appears in Annex I to the Directive. It can only be placed in Annex I if it passes a number of tests and uniform principles and is subject to relevant conditions which are set out in Annexes II to VI. Annex II sets out the requirements for the dossier to be submitted for the inclusion of an active substance in Annex I and Annex III sets out the requirements for the dossier to be submitted for the authorization of a pesticide. The distinction is because a pesticide may contain more than one active substance and there is a need to ensure that the pesticide can be safely stored and, as composed and used, has no harmful effect on human health or otherwise cannot cause unacceptable damage to organisms other than those it is designed to deal with or to the environment.
  11. Recitals 9 and 10 to the Directive read as follows:-
  12. "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."
  13. Article 4.1 is most important. So far as material, it provides:-
  14. "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).

  15. Before going to the annexes and in particular Annex VI, the following Articles are relevant. Article 5 deals with the inclusion of active substances in Annex I. Article 5(1) provides:
  16. "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.

  17. There are various relevant provisions which indicate the approach that should be adopted throughout the community to considering authorizations and inclusion of substances in Annex I. Article 4(3) requires Member States to 'ensure that compliance with the requirements set out in Paragraph 1(b) to (f) is established by official or officially recognised tests and analyses'. Article 5(2) is important. It provides:-
  18. "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).

  19. The acceptable operator exposure level (AOEL) is, as its description indicates, concerned with protection of operators, not directly of bystanders or residents. It is not necessary to go into the scientific technicalities in this judgment. Suffice it to say that (with some rare exceptions) tests cannot be carried out on humans and so the studies are mostly carried out on animals, usually rats, mice, dogs or rabbits. Some effects on humans can be taken into account where, for example, there has been accidental poisoning or if there have been any relevant epidemiological studies. The studies are designed to ascertain the relationship between dose and response by quantifying the response of laboratory animals to the active substance. A number of dose levels are used in order to identify the highest dose in a test which does not cause any statistically significant increase in frequency or severity of observable adverse effects: this is given the label NOAEL (No Observed Adverse Effect Level). It is obvious, and Mr Jay accepted, that it is not possible to identify whether certain adverse effects occur since animals cannot indicate whether they are suffering from, for example, a headache. Further, it is difficult to ascertain from (usually) short-term animal tests whether exposure over a long time may, by reason of a build up of the chemical in the body, produce adverse effects on health.
  20. The NOAEL is used as the basis for a reference dose which is the Acceptable Operator Exposure Level (AOEL). The Commission has issued guidance on the setting of AOELs. To allow for uncertainties in extrapolating from animal studies, and variations in response within the human population, the applicable NOAEL is divided by an uncertainty factor, currently 10 for animal to human and a further 10 for human variations, so that the applicable uncertainty factor is one hundredth. AOELs are expressed in terms of a daily amount, but that is designed to provide long term protection because the data used include long term studies. Mr Hamey, the principal scientist responsible for human exposure assessment at the Pesticides Safety Directorate (PSD), an executive agency of DEFRA, notes in Paragraph 17 of his first statement on behalf of the defendant:-
  21. "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.

  22. Annex II and Annex III contain detailed requirements as to what must be contained in the dossiers seeking inclusion of the active substance in Annex I or seeking authorization of a pesticide product respectively. Each dossier must supply the information necessary to enable there to be an evaluation of the foreseeable risks whether immediate or delayed, which may be entailed for humans, animals or the environment: see Paragraphs 1.1 of each Annex. Since the defendant is concerned with authorizations, Annex III is the more relevant for the purposes of this case. Part A sets out the requirements for authorization of pesticides which contain chemicals. Paragraph 7 deals with toxicological studies. It requires inter alia that tests must be conducted using the pesticide product to be authorized. Paragraph 7.1.4 concerns skin irritation and provides:-
  23. "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'. 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. 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 indicate that:-
    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"

    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.

  24. Point 7.2.2 deals with bystander exposure:-
  25. "Bystander 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.
    Estimation conditions
    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.

  26. Annex VI in B1 sets out, under the heading 'Evaluation', general principles. Evaluations must have regard to 'the proposed practical conditions of use and in particular to the purpose of use, the dose, the manner, frequency and timing of applications, and the nature and composition of the preparation.' B2 is headed 'Specific principles'. Point 2.4 deals with impact on human health. So far as material, it provides:-
  27. "2.4 Impact on human or animal health
    2.4.1 arising from the plant protection product 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. 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,
    2.4.2 Arising from residues Member States shall evaluate the specific information on toxicology as provided for in Annex II and in particular:
  28. Annex VI at C is headed 'decision-making'. Point 2.4 deals with impact on human and animal health. So far as material, it provides:-
  29. "2.4 Impact on human or animal health
    2.4.1. arising from the plant protection product 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. 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. 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. 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"
  30. Article 4(1)(b)(iv) has not been subjected to any specific consideration at Luxembourg. It is the claimants' case that an essential requirement of the Directive, as shown by the relevant recitals and in Article 4(.1)(b), is that no pesticide should be authorized for use unless it is established that it has no harmful effect on human health. This is therefore an overriding principle and the fact that the substance or substances are included in Annex I and the AOEL has been taken into account in that exercise cannot show that its use can be accepted. The defendant submits that the correct construction is that the Article 4 criteria are met by application of the uniform principles set out in Annex VI. Thus compliance with those principles will suffice since they expressly state that the AOEL must be taken into consideration in considering the risks to bystanders (see Annex VI B It is however to be noted that Annex IIIA 7.2.2 in considering bystanders expressly indicates that appropriate conditions of use include "exclusion of bystanders from treatment areas and separation distances".
  31. Two cases decided by the ECt and the Court of First Instance (CFI) respectively have considered the Directive. In European Parliament v Council of the European Union [1996] ECR I-2943, the ECt annulled a Directive which amended Annex VI because it failed properly to deal with the effects on groundwater, referring only to water intended for the production of drinking water. The court observed at Paragraph 25 of the judgment:-
  32. "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.

  33. More recently the CFI has considered the Directive in Sweden v The Commission, Case No. T-229/04, BAILII: [2007] EUECJ T-229/04, decided on 11 July 2007. The petitioner sought to have paraquat removed from Annex I of the Directive. Reliance was placed on various studies which showed exposure levels which were significantly greater than the AOEL. There was also a claim that a link between Parkinson's Disease and paraquat had not been mentioned in the dossier. In Paragraph 161 of the judgment, the court said:-
  34. "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.

  35. The Sweden case concerned an attack on inclusion of the substance in Annex I. Article 5 is concerned with that and not directly with authorizations in Member States of pesticide products containing active substances within Annex I. However, the fundamental requirement that human health be not harmed must in my view require that the precautionary principle is to be applied so that measures to ensure the protection of all who may be affected by use of the pesticide must be considered. If there is what the CFI describes as solid evidence that raises doubt as to the safety of the product unless conditions or restrictions on it are imposed, then the defendant must take all necessary steps to avoid the risk of harm if the pesticide is to be authorized. Any other approach would in my judgment not comply with the Directive.
  36. It is important to bear in mind that the Directive requires that a pesticide must not be harmful to human health. No qualification is applied to the adjective 'harmful'. Thus any harm is prohibited: it does not have to be chronic or lasting. I suggested that the test should be the same as used to identify actual bodily harm in s.47 of the Offences Against the Person Act 1861. In R v Donovan [1934] 2 KB 498 at p.509, Swift J, delivering the judgment of the Court of Criminal Appeal said:-
  37. "… '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 [1993] 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.

  38. In Ground 1 the claimant contends that no risk assessment has been carried out which can be held to have properly addressed exposure to residents. At an open meeting held on 10 July 2002 by the ACP, this was said by the representative of an interdepartmental group about what was needed for proper risk assessment:-
  39. "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.
  40. The assessment of exposure for bystanders is based on some experimental data obtained in a trial in 1983. These were based on the exposure (using dyes rather than chemicals for obvious reasons) of individuals exposed to a single pass of a sprayer standing 8 metres from the spray boom. In 1987 further similar trials were held in relation to spraying orchards. The RCEP commented on the calculations in paragraph 3.39 and 3.40 of its report as follows:-
  41. "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:
    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."
  42. It is apparent from this that the claimant is not alone in asserting that the bystander exposure model is inadequate for a proper assessment of the risk to the health of residents such as herself. She points out that in a paper sent to her by the PSD in 2001 headed 'Bystander Exposure Examples' it is said that bystander exposure would result primarily from drift and such exposure "is likely to be of short duration, is unlikely to be repeated, and is likely to be at a lower level than that affecting the sprayer operator considering the greater distance of a bystander from the application equipment". These assumptions would not necessarily apply to residents. It is apparent that it was then assumed that there was a 1 minute exposure. Mr Hamey at the ACP open meeting in July 2002 stated:-
  43. "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.

  44. In her second statement, the claimant sets out details of the deficiencies in the approach to the assessment of risk for bystanders. Mr Hamey prepared two papers in January and July 2003. That of January considered four other potential sources of exposure for bystanders, namely exposure at less than 8 metres, 24 hour inhalation exposure to pesticides in the air after spraying, exposure to pesticides in harvest dust and dermal and oral exposure (excluding inhalation) of children in gardens. At 1 metre, dermal exposure was some 8 times the level at 8 metres. It was acknowledged that "the recent trials show that closer to the sprayer bystanders may experience higher exposures than currently predicted". The 24 hour inhalation exposure took account of three sets of data from the U.K., Germany and California respectively. While the U.K. data was said to show that long term air levels were considerably lower than the estimated levels experienced by a bystander from contact with the spray cloud at the time of the application, the cumulative effect of such exposure over years was not considered. Further, as the PSD pointed out, high levels of a particular pesticide had been identified 300 metres from the sampling station. The German and Californian data showed higher levels of concentration in the air than assessed by the model used in the U.K. The consideration of harvest dust by the PSD suggested that bystanders were not likely to remain exposed: they would go away. That option, as the claimant points out, is not available to residents, unless they are expected to vacate their homes while harvesting takes place. It was accepted that a small child playing in a garden adjacent to a sprayed field for two hours would absorb through dermal and oral exposure at an order of magnitude higher than that estimated through contact with spray drift. No change has been made to the current bystander assessment following these four factors.
  45. The claimant has drawn attention to calculations annexed to the PSD paper of July 2003. These gave examples of exposures to some 15 products which were in excess of 100% of the AOEL. One product, Dithianon Flowable, showed exposures to the active substance, dithianon at 8 metres exceeding the AOEL by a very large percentage (as high as over 3000%). At closer than 8 metres, the excess would be up to 8 times more. The distance of 8 metres was, it seems, chosen because 'any person closer would be more likely to have some involvement in the pesticide application, and therefore be wearing at least overalls'. That is what Mr Hamey said in an article in Pesticide Outlook in October 2003. This, as the claimant points out, does not take account of residents who live next to fields being sprayed, who may be affected by sprays which pass at less than 8 metres and who will not normally be wearing any protective clothing. Despite the excesses recorded, the view was taken that the current approach was protective of longer term bystander exposure, albeit it concluded:-
  46. "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.

  47. Mr Hamey has in a second statement sought to deal with these matters. He points out that in April 2004 there was an amendment to the conditions for approval for Dithianon Flowable and that another product containing Dithianon was withdrawn by the approval holder and the approval revoked in July 2003. Mr Hamey stated the California and German data had been factored into the bystander assessment as has exposure to children by way of skin contact and, as he puts it, hand to mouth activities in neighbouring gardens. However, the claimant makes the point that authorisations were granted to products which, as it turned out, produced exposure rates to bystanders which were well in excess of AOEL so that they may well have constituted a health hazard. While I appreciate that it is said that those figures may be a worst case scenario, nonetheless they suggest that the model being used may not have been even on its own terms, entirely satisfactory.
  48. When giving evidence to the RCEP on 4 November 2004, Professor Coggon said, in relation to the model:-
  49. "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.

  50. But Professor Coggon makes the point that the model in question is used as the base. It assumes a 5 minute exposure every day during the spraying season. It is then assumed that there exist worse conditions than could normally be expected to apply, namely wind speeds greater than the maximum recommended for spraying, spray nozzles set so as to make the greatest amount of drift and no clothing worn which could protect. Having made these assumptions and added in the 1 metre test, the view taken by the ACP was, as it stated in Paragraph 3.21 of its response to the RCEP report:-
  51. "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.

  52. In Paragraph 56 of her second statement, the claimant sets out in detail her contentions which lead her to conclude that the current bystander model does not and cannot assess the exposure of residents and is also inadequate to assess that of bystanders who may be exposed on only one occasion. She makes the point that children, for example, may be exposed not only at home but also at school if, as can be the case, the school is adjacent to a field which is sprayed. All exposure factors must be but are not taken into account in the exposure calculations. Food may be exposed if, for example, in the summer during the spraying season a barbecue is held. There is no system in place which requires farmers to inform residents in advance that spraying is to take place and, despite the assertion that a voluntary code should enable that information to be made available, it is the claimant's experience that it is not. Particles can remain in the air for some time and thus be inhaled. The lingering chemical fumes after spraying show this occurs. It is confirmed by a study paper assessing the occurrence of pesticides in the atmosphere in France. As long ago as 1975 MAFF warned of the need to avoid inhaling fine particles produced by aerosol sprays. A similar point was made in a publication by Cornell University headed Toxicity of Pesticides in which this was said:-
  53. "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.

  54. The claimant points out that residents can receive exposure from multiple applications, including sequential or repeated spraying applications, over a number of years. This, she says, has not been properly taken into account. The cumulative effects of pesticides can produce damage to health. Indeed, in its 1975 document, MAFF stated:-
  55. "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. "
  56. It is important to bear in mind that operators and workers are not the only individuals who are exposed to pesticides and, while their protection is of course most important, they can benefit from the use of protective clothing and other measures not available to residents. Some individuals may be particularly vulnerable (for example, the asthmatic, the elderly, children, pregnant women), but they must be protected too.
  57. I have not referred to all the matters raised by the claimant in her very lengthy and detailed statement. I hope that I have adequately summarised the important points she makes in attacking the adequacy of the model used to assess exposure for bystanders. It is her case that this model cannot assess the risk to residents.
  58. The defendant's response engages with the expert evidence and is helpfully set out in some detail in Mr Jay's skeleton argument which is (and this is no criticism) lengthy and has much flesh to it. Mr Hamey explains that the studies, chiefly on animals, are designed to ascertain the relationship between dose and response by quantifying the response of the laboratory animals to the active substance. From this, the highest dose level which causes no statistically significant increase in frequency or severity of observable adverse effects can be identified and is the NOAEL. This is based on the most sensitive end-point in the most relevant species (or, occasionally, if the data is available, in humans). The European Commission's Guidance, applying what is required in Annexes III and VI, is then followed. The division by 100 in the extrapolation process produces a further safety margin. Mr Hamey noted:-
  59. "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."
  60. There is set out a detailed justification of the method adopted by those advising the defendant. The ACP, an independent body whose members include scientists, have satisfied themselves that, despite some shortcomings in the model, the approach produces a situation which complies with the Directive and provides adequate protection for all likely to be exposed to pesticides. I have in identifying the claimant's objections indicated the relevant matters relied on by the defendant and I do not think it is necessary to lengthen this judgment by going through all those in detail. There are conflicting views as to the adequacy of the approach adopted: so much is apparent from the report of the RCEP and the response by the ACP. I am not qualified to decide between those views nor is it an appropriate exercise for a judge to undertake on judicial review. No doubt if it were clear that one view was tainted by irrationality in the Wednesbury sense, the court could so declare. But that is most unlikely to be established and, as it seems to me, we are here at the very fringe of what should properly be the subject of judicial review. As May LJ said in a different context in R(Campaign to End All Animal Experiments) v Secretary of State for the Home Department [2008] EWCA Civ 417 in paragraph 1:-
  61. "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."
  62. The alleged inadequacies of the model and the approach to authorisation and conditions of use have been scientifically justified. The claimant has produced cogent arguments and evidence to indicate that the approach does not adequately protect residents and so is in breach of the Directive. The RCEP found inadequacies and recommended further measures to deal with them. Its view was rejected by the ACP and by the defendant who accepted the ACP's advice. If that were the only matter relied on in challenging the defendant, I would not be able to find in the claimant's favour.
  63. It is not however all by any means. There is in my judgment solid evidence produced by the claimant that residents have suffered harm to their health (her own ill health is an example) or, at the very least, doubts have reasonably been raised as to the safety of pesticides under the regime which presently exists: see the Sweden case at paragraph 161. It is clear that the precautionary principle must apply.
  64. In his paper prepared for the ACP open meeting in July 2002, Mr Hamey referred under the heading 'Post Approval' to the Pesticide & Incidents Appraisal Panel (PIAP) of the Health and Safety Executive. The HSE produces annual reports in which PIAP considers all incidents reported to the HSE where the use of pesticides is said to have caused ill-health. The reported incidents are placed into one of five categories which are identified as follows:-
  65. Confirmed 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
    Likely 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
    Open assessment (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
    Unrelated There is strong evidence, e.g. evidence about exposure or from medical reports, that the reported ill health is not pesticide-related
    Insufficient information The available data are insufficient, incomplete or conflicting and the panel is unable to classify a case for one or more of these reasons.

  66. The 2003-2004 report as an example disclosed that there had been 204 reported pesticide incidents,62 of which involved allegations of ill-health. Of these, 1 was 'confirmed',14 were 'likely' and 3 were 'open'. 13 were described as 'pending'. Of those 18 in the first three categories, all involved members of the public. The panel recorded the severity of the symptoms as 'mild (requiring no or self treatment), 'moderate' (presenting to a GP or hospital AED) or 'severe' (in-patient treatment). In paragraphs 37 and 38 the panel's observations in respect of severity are set out. They read:-
  67. "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.

  68. While no doubt there are a very small number of incidents reported each year, it is likely that there is a substantial degree of under reporting. Most effects are local and classified as mild or moderate, if ascribed to pesticide exposure. But, having regard to the definition of harm to human health and the requirement of absolute protection, many such cases would be regarded as constituting harm. An obvious example is irritancy which would often not properly be regarded as merely transient and trifling. Furthermore, most incidents related to crop spraying and the effects resulted from spray drift or exposure to vapour or fumes. It is, I think, worth quoting paragraphs 74 to 78 of the claimant's second statement in this regard:-
  69. "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.

  70. It is suggested by the Defendant that there is no risk of local effects by exposure to dilute spray. Operators may be exposed to concentrate but bystanders will not. In paragraphs 48 to 50 of his first statement, Mr Hamey stated as follows:-
  71. "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."
  72. I have already made the point that warnings cannot help bystanders or residents. But the Code of Practice produced by the PSD, HSE, the Welsh Assembly and Defra in 2006 states in Paragraph 4.6.8 under the heading Using Vehicles Without Cabs:-
  73. " 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.

  74. The claimant has encouraged residents where health has in their view been affected by exposure to pesticides to contact her. She has visited a number of those who have contacted her and produced a DVD of their circumstances. Local effects such as have been reported to PIAP have been recorded. Chronic long term illnesses which are alleged could result from exposure include various cancers, Parkinson's Disease, Myalgic Encephalomyelitis, asthma and others. I recognise that it is not easy to attribute a particular cause to many chronic illnesses and a view that a cause has been identified may be wrong. But there is evidence that some long term illnesses may be attributable to pesticide exposure.
  75. But there is much more positive evidence that local effects are attributable to exposure. The DVD makes it clear that those effects do in many cases amount to more than merely transient and trifling harm. I appreciate that the DVDs have been presented to and considered by the ACP and they have not changed their approach. Had they appreciated that the evidence was solid and that the conditions come within the scope of the Directive inasmuch as they constituted harm to human health, a different approach ought in my view to have been adopted. There has in my judgment been both a failure to have regard to material considerations and a failure to apply the Directive properly. It is in the context relevant to note that the view that local effects need not be taken into account, albeit apparently in the European Commission Guidance, cannot be justified. The reason for their exclusion is, it seems, because packet warnings can deal with them. But, as I have said, that cannot possibly help bystanders. In any event, there is sufficient material to raise a real doubt as to long term harm in some cases. They may be rare, but it is to be noted that in the Sweden case one study was regarded as sufficient to require paraquat to be removed from Annex I.
  76. This leads me to Ground 2. In its Guide to Pesticide Regulation published by the HSE and Defra, it is said that the legislative framework is designed with the aim that inter alia 'no-one should develop any serious illness through the use of pesticides'. The same paragraph 4 goes on to say:-
  77. "… 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."
  78. The claimant had raised the question of the appropriateness of the qualification indicated by the inclusion of the word serious. In a letter to an MP of 16 February 2006, the then responsible minister, Lord Bach, said:-
  79. "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."
  80. Mr Jay draws attention to paragraphs 5.2.4 and 5.2.5 of Annex IIA to the Directive which state:-
  81. "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.

  82. The argument is developed by reference to paragraph 2.10 of the Commission Guidance which I have earlier noted but which reads in full:-
  83. "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.

  84. I do not think, for the reasons already given, that that submission can prevail. A determination of skin and eye irritancy is required. That is because it can constitute harm to human health. Since AOEL has to be determined, it is clearly a material starting point for bystanders. But bystanders cannot benefit from warnings or protective clothing. Thus the risks to their health cannot depend solely on the AOEL, although it may require some evidence of a real risk of such harm to justify a refusal of authorization or conditions. Such evidence clearly exists. Thus as it seems to me there cannot be compliance with the Directive if such risks are not taken into account and measures taken to remove them.
  85. As I have said, the word serious should not have been used. It suggests an erroneous approach. However although it should be removed from any guidance, if the approach is and has always been as Professor Coggon suggested in the article quoted in Paragraph 48, it may not in itself have resulted in an erroneous decision. However, since the defendant accepts that harm will be material if more than merely trifling and transient, he must make his decisions on that basis.
  86. Ground 3 can, I think, be dealt with relatively shortly. It is of some significance that the RCEP was asked to look into the question of risk management. The then minister (Alun Michael) in referring the issue to the RCEP said this:-
  87. "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.

  88. The independent analysis by the RCEP concluded that the present system was inadequate. In paragraphs 3.50 to 3.56 it stated:-
  89. "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."
  90. It also considered what measures should be taken to ensure that conditions set out in the Code of Practice (The Green Code) were being met, that residents be notified in advance of proposed spraying applications and the substances to be used and whether buffer zones should be applied. They recommended that the Green Code conditions should become statutory duties, that the necessary information should be given to residents and that buffer zones, initially of 5 metres, should be required for the protection of residents.
  91. The ACP rejected the RCEP's conclusions and recommendations based on the inadequacy of the existing assessment and the need to replace the current approach by a computational model which was probabilistic. The model's validation should be supported by monitoring of representative pesticides in a range of field conditions. It regarded the recommendation for compulsory 5 metres buffer zones to be a disproportionate response to scientific uncertainty. While agreeing that there were scientific uncertainties, in particular relating to various long term disorders and the estimation of realistic upper limits for the exposures of 'bystanders', they regarded these as minor and no greater than those that existed in other aspects of human health risk assessment for pesticides or for other environmental health hazards. In paragraph 3.32 of its response it stated:-
  92. "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."
  93. It rejected a probabilistic model because of the difficulties in gathering the necessary data and the difficulty in following such models which made them lack transparency. But in paragraph 3.34, it said:-
  94. "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.

  95. It did not accept that the Green code conditions should be made statutory duties. It believed the law would not be enforceable. It is difficult to see how a voluntary approach could be more effective: it is totally unenforceable. But it must be recognised that not every condition would necessarily be suitable for statutory enforcement, although some might. It supported in general terms the need for information but was concerned whether it could be put into effect.
  96. The RCEP responded to the ACP's rejection of its main conclusions. The government decided in effect not to implement any of the relevant recommendations. It took into account the cost considerations involved and decided that they were not proportionate for the suggested benefits. It dealt with the recommendation that notice be given to residents as follows:-
  97. "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."
  98. While recognising the problems created by additional bureaucracy, it is of interest to note that the Control of Pesticides Regulations 1986 as amended (in relation to aerial spraying of all pesticides) and the statutory conditions of use (in relation to ground spraying of certain pesticides which are harmful to bees) require that 48 hours notice must be given to beekeepers. There may be many whose bees could be affected. It is difficult to see why residents should be in a worse position.
  99. The ACP had advised that the existing system was satisfactory. The minister had acted on that advice. Public disquiet led to the independent evaluation by the RCEP. That found inadequacies and a need for measures to provide clear protection for bystanders and residents in particular. It may seem that in the circumstances the conclusions of the RCEP could be seen to be a criticism of the ACP and so the ACP's reaction could be regarded as unsurprising. However, the minister cannot be said to have erred in law by relying on scientific advice from the ACP in preference to that from the RCEP.
  100. Mr Fordham submitted that the defendant could only reject the report and recommendations if he had and set out clear and compelling reasons for so doing. He relies in particular on R v Avon County Council ex p M [1994] FLR 1006. That case involved an authority rejecting advice, not choosing between conflicting advice. The views of the ACP coupled with the defendant's own reasons do in my view provide all that is necessary. He is entitled to choose between experts after considering the advice. Furthermore, he is entitled to have regard to cost and whether measures are proportionate in the light of the advice accepted by him. It is said that the defendant simply preferred his own view. That is not to paint the full picture. If this ground stood alone, it would not in my judgment prevail. But, as I have already indicated, it does not.
  101. I reach this conclusion because I accept that the test must be a Wednesbury one. While the added consideration of human rights must be taken into account (I shall deal with the argument based on Article 8), there is ample authority which makes it clear that a judge must be astute not to substitute his own view for that of the decision maker unless the decision maker has failed to have regard to a material factor, has had regard to an immaterial factor or has reached a truly perverse decision. The defendant in this case was bound to act on the advice given to him by experts. The advice conflicted and so he was entitled to choose between them. The ACP, supported in some respects by other bodies, told him that the RCEP conclusions were not appropriate. The ACP, albeit it has maintained that there was no immediate need for further action and so was subjected to implicit criticism by the RCEP and so could be regarded as having an interest in supporting its advice, was an independent body. Thus, as I say, the refusal to follow the RCEP's recommendations would not by itself have amounted to an error of law.
  102. Reliance is placed on Article 8 of the ECHR. The applicant has shown that there may have been long term damage to her health resulting from the exposure to pesticides over a number of years and her DVD indicates that others may have suffered in the same way. None of what is produced establishes the causal link: the establishment of such a link scientifically is a very difficult exercise and what may seem obvious to the victim or to the inexpert observer may in reality not be so. It is however to be noted that the medical tests carried out on the Claimant provide very powerful reasons for concluding that there has been the necessary cause and effect. In Asserbourg v Luxembourg (Case No: 29121/95 decided on 29 June 1999) the claimants were concerned that licences granted to a steel works failed properly to avoid the risk of air pollution which directly affected them as they lived nearby. For example, the vegetables they grew had to be thrown away because they were contaminated by heavy metals and their health too was at risk. The court made the point that there was access to civil and indeed criminal remedies if there was any failure to comply with the licences. The applicants failed because they had not established a direct link between the conditions imposed by the licence and personal damage that was at least reasonably foreseeable.
  103. The claimant refers to Lopez Ostra v Spain (1994) 20 EHRR 277. The applicant in that case was able to show that she and others living near a plant treating waste had suffered serious damage to their health as a result of emissions from it. Guerra v Italy [1998] ECHR 7 was another such case. Inhabitants of a particular town had been seriously affected by emissions from a chemical factory, including those on one occasion caused by an explosion at the factory. In paragraph 58 of its judgment the court said this:-
  104. "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.

  105. No doubt in principle a failure to take necessary protective action can produce a breach of the Article. But it seems to me that in the circumstances of this case the Article 8 claim adds nothing. If the defendant's approach complies with the Directive, any interference with the Article 8 right will be in accordance with the law. If it does not comply, it will not be in accordance with the law, but Article 8 is not needed since the failure to meet the obligations imposed by the Directive means that the claimant has a domestic remedy. If there is compliance, it is apparent that, in considering proportionality, the economic well being of the country and the protection of the rights and freedoms of others, namely the farmers, are material. Any failures by a farmer to comply with the Green Code may enable a private law remedy in tort to be pursued. Equally, if damage to health is established, a remedy in tort may be available and can be pursued. Equally, in assessing proportionality, cost is relevant.
  106. I have no doubt for the reasons I have given that the manner in which controls on crop spraying have been applied do not comply with the obligations imposed by the Directive. It is clear and the contrary has not been suggested that the model is by no means perfect. It cannot measure local effects and is, as Mr Jay accepted, not able adequately to assess possible long term effects on health. In those circumstances, the Article 8 ground is not needed. Further, I do not believe it would provide a remedy if it stood alone. If there were compliance with the law, it is impossible to see that any interference with private life would be disproportionate.
  107. It is said on the defendant's behalf that the U.K.'s approach is stricter than that of many other Member States. That may be so but is not of particular materiality. I have had to consider what the Directive requires. I have been persuaded that there are defects in the defendant's approach which contravene the requirement of the Directive. If that means that other Member States are not complying, that is a matter for them, their citizens and perhaps the Commission.
  108. The result of this judgment is that the defendant must think again and reconsider what needs to be done. It is not for me to specify any particular action he needs to take. He must take steps to produce an adequate assessment of the risks to residents. In addition, he must carefully reconsider whether the existing conditions of use are adequate. The need to inform residents of intended spraying and of the composition of the pesticides to be used is I think clear. Voluntary action is not achieving this. Equally, I think there is a very strong case for a buffer zone, such as incidentally already exists to avoid spraying too close to watercourses in order to minimise the risk of pesticides entering groundwater.
  109. I am inclined to the view that the appropriate remedy may be a declaration that the defendant is not acting in compliance with the Directive in the respects identified in this judgment and that he remedies his policy in the light of this judgment. But I will hear submissions on the precise terms of any order.

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