Downs v Secretary of State for Environment, Food and Rural Affairs

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.

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.

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.

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.

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.

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).

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:

“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.”

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.

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.

Recitals 9 and 10 to the Directive read as follows:-

“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.”

Article 4.1 is most important. So far as material, it provides:-

“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).

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:

“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.

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:-

“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).

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.

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:-

“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.

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:-

“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’. 7.2.1.1 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. 7.2.1.2 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 7.2.1.1 indicate that:-

-

the AOEL(s) established in the context of inclusion of the active substance(s) in Annex I, and/or

-

the Limit Values established for the active substance and/or toxicologically relevant compound(s) of the plant protection product …[which relates to carcinogens]

may be exceeded.

Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under Point 7.2.1.1.”

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.

Point 7.2.2 deals with bystander exposure:-

“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.

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:-

“2.4

Impact on human or animal health

2.4.1

arising from the plant protection product

2.4.1.1 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.

2.4.1.4 Member States shall evaluate the possibility of exposure of other humans (bystanders or workers exposed after the application of the plant protection product) or animals to the active substance and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use.

This evaluation will take into consideration the following information:

(i)

the toxicological and metabolism studies on the active substance as provided for in Annex II and the results of the evaluation thereof, including the acceptable operator exposure level:

(ii)

the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies:

(iii)

other relevant information on the plant protection product as provided for in Annex II such as:

– re-entry periods, necessary waiting periods or other precautions to protect humans and animals,

-

method of application, in particular spraying,

-

maximum spray application volume,

-

composition of the preparation,

-

excess remaining on plants and plant products after treatment,

-

further activities whereby workers are exposed.

2.4.2

Arising from residues

2.4.2.1 Member States shall evaluate the specific information on toxicology as provided for in Annex II and in particular:

-

the determination of an acceptable daily intake (ADI),

-

the identification of metabolites, degradation and reaction products in treated plants or plant products,

-

behaviour of residues of the active substance and its metabolites from the time of application until harvest, or in the case of post-harvest uses, until outloading of stored plant products.”

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:-

“2.4

Impact on human or animal health

2.4.1.

arising from the plant protection product

2.4.1.1. 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.

2.4.1.2. 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.

2.4.1.3. 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.

2.4.1.4. 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 2.4.1.1.”

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 2.4.1.4(i)). 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”.

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 1-2943, 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:-

“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.

More recently the CFI has considered the Directive in Sweden v The Commission, Case No. 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:-

“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.

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.

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:-

“… ‘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.

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:-

“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.

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:-

“3.39

The standard exposure assessment used by the PSD represents a pragmatic approach to a complicated problem. Given the assumptions of an unclothed bystander, high breathing rate, proximity to the boom, the uncertainty factor of 100 that has been used in calculating the AOEL from animal toxicology data, and with some account being taken of repeated exposure, the assessment is probably conservative and protective in the majority of situations. However, the assessment only accounts for exposure through spray drift and essentially ignores the complex phenomena governing it. There is no indication, for example, that the well-regarded research on spray drift that has taken place over many years at the Silsoe Research Institute, funded by the Department for Environment, Food and Rural Affairs (Defra), has been used to evaluate the validity of the approach used and assumptions made, or to develop the approach further. As a result, the PSD approach, defined by the standard formula (box 3A), suffers from the following serious shortcomings:

•

It is based on a gross simplification of real exposure and it does not address all of the possible exposure routes. It is based on single-valued parameters from a limited set of experiments and does not attempt to represent the physical mechanisms that determine the extent of exposure and takes little account of the variability of dispersion conditions encountered in practice;

•

It explicitly takes into account only exposure by spray drift at the time of spraying by bystanders in the narrow sense, as defined in 1.19, (though the additional papers, ACP9(297/2003) and ACP20(301/2003), contained preliminary estimates of some other exposures to residents and others including inhalation of vapours and ingestion of soil);

•

It is based on very limited data obtained in the 1980s, since when, farm practices have changed significantly; for example tractors are capable of significantly faster speeds, boom sizes have increased, formulations have changed and the concentrations and flow rates used are often different;

•

It assumes good operational practice; for example spraying only in recommended weather conditions (although high wind speeds were recorded during some trials) and at moderate vehicle speeds;

•

Average values from the 1980s trials were used to estimate the PDE and PIE, with no account take of the large variability due to turbulence in the atmospheric boundary or of the dependence of drift on wind speed (3.12, figure 3-VI);

•

It does not taken into account the important vertical variation in the profiles of spray drift (figure 3-VII) and their change with distance and wind speed (figure 3-VI);

•

Though a separate risk assessment is undertaken for re-entry to the sprayed field and subsequent contact with treated foliage, which can be extended to individuals walking within a recently sprayed field, the standard formula does not include this route of exposure or risk assessment; and

•

No account is taken of the possible importance for airflows and therefore spray drift, of topographic features such as sloping, or irregular ground and also the effect they have on boom height, particularly if the tractor is driving at higher speeds.

3.40

Overall, we believe the PSD approach, even after its re-evaluation in 2003 which resulted in no change to the formula, is best described as yielding an approximate exposure estimate based on data which happened to be available, rather than a scientific prediction validated systematically by specifically designed experiments. Full details of the experimental conditions for the original 1983 and 1987 trials are not given and the approach has not been validated by the kind of peer review necessary for publication in the open scientific literature.”

While it indicates that ‘the assessment is probably conservative and protective in the majority of situations’, it identifies what it regards as serious shortcomings. In considering its July 2003 discussion paper, the ACP had concluded that the examples used were appropriate and could be identified as worst case scenarios and that, with one possible exception relating to soil fumigants, the approach taken to assess bystander risks was generally protective. The RCEP commented:-

“3.44

We consider that the present approach may be conservative and protective in its treatment of targets but in view of the absence of any attempt to model the complexity of bystander exposure and the probability of extreme values, we cannot agree that this has been conclusively or transparently demonstrated for the exposure process. We cannot therefore support the ACP’s unequivocal conclusion above.”

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:-

“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.

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.

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:-

“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.

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.

When giving evidence to the RCEP on 4 November 2004, Professor Coggon said, in relation to the model:-

“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.

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:-

“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.

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:-

“Whether as dusts, spray mist, or fumes, pesticides can be drawn into your lungs as you breathe. Inhalation of pesticides can occur during the mixing of wettable powders, dusts, or granules. Poisoning can also occur while fumigating or spraying without a self contained breathing apparatus or a proper respirator in enclosed or poorly ventilated areas such as greenhouses, apartments, or grain bins. The largest particles that are inhaled tend to stay on the surface of the throat and nasal passages, and do not enter the lungs. Smaller particles can be inhaled directly into the lungs. The number of particles needed to poison by inhalation depends upon the concentration of the chemical in the particles. Even inhalation of dilute pesticides can result in poisoning. Once they are absorbed through the surfaces of the lungs, chemicals enter the blood stream and are distributed to the rest of the body.”

The claimant further says that it is apparent from studies that low volatility pesticides tend to accumulate on the soil surface. As water evaporates, volatilisation increases with time, a point which has not, she avers, been considered by the defendant.

The 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:-

“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. ”

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.

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.

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:-

“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.”

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:-

“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.”

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.

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.

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:-

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:-

“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.”

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:-

“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 17^th 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.