IN THE HIGH COURT OF JUSTICE No. CO/3087/2001
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
B e f o r e :
MR. JUSTICE CRANE
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| | THE QUEEN on the application of
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| | AMVAC CHEMICAL UK LIMITED
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| | and
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| | (1) SECRETARY OF STATE FOR ENVIRONMENT, FOOD
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| | AND RURAL AFFAIRS
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| | (2) SECRETARY OF STATE FOR TRANSPORT, LOCAL
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| | GOVERNMENT AND REGIONS
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| | and
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| | FOOD STANDARDS AGENCY
| |
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(Transcript of the Handed Down Judgment of
Smith Bernal Reporting Limited, 190 Fleet Street
London EC4A 2AG
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Lord Brennan QC and Mr.David Wolfe appeared for the Claimant.
Mr.Richard McManus QC and Mr.Philip Coppel appeared for the Defendants.
Mr.Philip Coppel appeared for the Interested Party
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CROWN COPYRIGHT ©
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Crown Copyright ©
MR JUSTICE CRANE:
The issues
- The Claimant challenges a decision communicated on 4 August 2001 to suspend regulatory approvals for dichlorvos, a chemical used in pesticides. On 6 August Newman J. ordered a stay of that decision and of the public announcement of that decision.
- On 23 October 2001 Silber J. heard the application for permission to apply for judicial review. He did not grant permission to challenge the merits of the decisions on substantive grounds. Permission was granted on the following basis:
(1) Was the decision unlawful because the Claimant was not adequately informed or warned of the regulatory basis upon which suspension/revocation was being made or considered? Or because the Claimant was not given adequate information with which to make submissions on such matters? Or because the Claimant was not given adequate time within which to make submissions on such matters?
(2) Was the decision unlawful because the Defendants were obliged to have proper regard to the "precautionary principle" as enunciated, and its mechanisms? Or because they failed to have proper regard for that principle and its mechanisms? Or because they did not have or give good reason for failing to have proper regard to the principle?
(3) Was the decision to suspend/revoke the approval unlawful, having regard to the Claimant's rights to enjoy their possession under Article 1 of the First Protocol of the European Convention on Human Rights?
- If the Claimant succeeds on any basis, the question arises whether the court's discretion should be exercised to grant the remedy sought.
- Cresswell J. granted to the Food Standards Agency permission to be heard and to file evidence. That was granted on paper and without a hearing. Evidence has been filed. Mr.Coppel has made short submissions on behalf of the Agency. In the ultimate analysis no submissions have been made on behalf of the Agency that could not adequately have been put forward by the Defendants. The essential point being made by the Agency is that the products in question could affect food.
Hearing in private
- Both previous hearings were held in private. At the outset of the hearing before me, the Claimant applied for the hearing of argument to take place in private, with only judgement given in open court. I heard that application in private, but refused it. I offered to give my reasons then, but counsel for the Claimant, having taken instructions, indicated that the Claimant was content that I give my reasons in this judgement.
- Under CPR 39.2(1):
"The general rule is that a hearing is to be in public".
- CPR 39.2(3) reads, in so far as it is relied on here:
"A hearing, or any part of it, may be in private if -
(a) publicity would defeat the object of the hearing; …
(c) it involves confidential information (including information relating to personal matters) and publicity would damage that confidentiality; …
or
(g) the court considers this to be necessary, in the interests of justice".
- Article 6 of the European Convention on Human Rights provides in my view a slightly stricter test:
"In the determination of his civil rights and obligations … everyone is entitled to a fair and public hearing … . Judgment shall be pronounced in public but the press and public may be excluded from all or part of the trial in the interest of morals, public order or national security in a democratic society, where the interests of juveniles or the protection of the private life of the parties so require, or to the extent strictly necessary in the opinion of the court in special circumstances where publicity would prejudice the interests of justice" (my italics).
- The thrust of the Claimant's argument is that public reference to possible risks from dichlorvos, prior to a reasoned judgment stating the court's conclusions, could cause irreparable damage to the market for dichlorvos products here and abroad. Counsel for the Claimant was not able to point to any decided case in which a hearing had been in private in circumstances such as the present, apart from the two previous hearings in the present case. I accept that there may have been unreported decisions, particularly at the interlocutory stage. The previous decisions in the present case were necessarily made after limited argument. There is in any event a distinction to be drawn between interlocutory or permission hearings and a final hearing.
- I bear in mind that the substantive challenge to the Defendants' decision is no longer live, except in so far as substantive issues are relevant to the precautionary principle and Article 1 challenges.
- I am not prepared to agree with counsel for the Defendants that there could never be a case involving a regulatory issue in which a private hearing of argument (or part of the argument) would be ordered in the light of CPR 39.2(3)(a) or (c). However, I bear in mind particularly the principles set out by the Court of Appeal in R. v. Legal Aid Board, ex parte Kaim Todner (a firm) [1999] QB 966. Although that case dealt with the anonymity of a claimant, its relevance to the present issue was accepted on all sides. As Lord Woolf MR said (at 978), it is not unreasonable to regard the person who initiates the proceedings as having accepted the normal incidence of the public nature of court proceedings. The protection to which they are entitled is normally provided by a judgment delivered in public.
- I was and am satisfied that no sufficient grounds for a hearing in private have been made out, applying either the CPR test or the Article 6 test. A public hearing will not defeat the object of the hearing. No confidential information of significance has been identified. There was and is no special reason to fear that any reporting of the case would be unbalanced. The Defendants have given an assurance that the Claimant would be informed in advance of any comment they proposed to make about the hearing. Although it was always likely that I should reserve judgement, a judgement of the court was always likely within a reasonably short time of the close of argument.
The regulatory regime
- The Food and Environment Protection Act 1985, section 16 provides for the control of pesticides. Section 16(2) enables Ministers to make regulations for a regulatory regime requiring approval of pesticides. The Control of Pesticides Regulations 1986 were duly made. Their effect is to prohibit the selling, supply, storage or use of a pesticide without approval. By section 16(1) of the Act, the purposes of the relevant Part of the Act are set out. Section 16(1) reads:
"The provisions of this Part of this Act shall have effect -
with a view to the continuous development of means -
to protect the health of human beings, creatures and plants;
to safeguard the environment;
to secure safe, efficient and humane methods of controlling pests; and
with a view to making information about pesticides available to the public;
and references in this Part of this Act to the general purposes of this Part of this Act are references to the purposes mentioned in this subsection".
- Under the Department for the Environment, Food and Rural Affairs, the Pesticides Safety Directorate is an executive agency with responsibility for pesticide approvals. As they were entitled to do under section 16(7) of the Act, Ministers established a committee to give them advice: the Advisory Committee on Pesticides ("the ACP"). Once the committee was established, Ministers are required by section 16(9) to consult the ACP inter alia as to approvals they contemplate giving, revoking or suspending and as to conditions to which they contemplate making approvals subject. The Health and Safety Executive supply secretariat services to the ACP. By section 16(9A) and (10) of the Act, consultation is required in certain circumstances with the Food Standards Agency and the Health and Safety Executive.
- The case also features the Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment ("the COM"). It is an independent scientific advisory committee reporting to the Government's Chief Medical Officer and the Chairman of the Food Standards Agency. It provides advice to Government Departments and Agencies on all aspects of mutagenicity (a term to be defined later). The Committee on Carcinogenicity ("the COC") performs an analogous function. These committees are, as I understand it, not statutory, but are for obvious reasons consulted when appropriate.
- Section 16(11) of the Act provides extensive powers to Ministers to require disclosure of information about products by those seeking or holding approvals.
Terminology
- "Mutagenic" means causing or capable of causing mutation. "Carcinogenic" means able to cause cancer or carcinoma. "Genotoxic" means, in relation to a substance (especially a carcinogen), having the property of producing a direct toxic effect on genetic material. It is not in dispute that although these are distinct qualities, one may be associated with one or both of the others. Nor is it in dispute that scientific studies demonstrating the presence or absence of one of these qualities in a substance may be relevant is considering whether another of these qualities exists. However, carcinogenicity may arise from causes that are not genotoxic.
The Claimant and dichlorvos
- The Claimant is an English company, wholly owned by the Amvac Chemical Corporation of California. Dichlorvos (or DDVP) is a pesticide with both agricultural and non-agricultural uses. The Claimant manufactures dichlorvos only for non-agricultural uses. The Claimant has itself held only one approval: a provisional approval for "Anopav Fly Killer" "NOT TO BE MARKETED". The Claimant's concern, however, is wider, because they supply dichlorvos to other approval holders, including a company called Sarah Lee, who are distributors of such products. The Claimant is also concerned that any withdrawal of approval in this country would lead to regulators in other jurisdictions taking action and that markets elsewhere would be affected.
- I shall return to the question of the Claimant's precise interest when I consider the Article 1 issue. However, it is clear that in its dealings with the regulatory authorities the Claimant was seeking to protect its commercial interests in the supply of dichlorvos products by distributors, not simply as the holder of one provisional approval "not to be marketed". The regulatory authorities were aware of that. They throughout treated the Claimant as entitled to submit material relating to those other products. The Defendants have not sought to confine the Claimant's submissions to its own single approval.
The procedural challenge: the history
- In order to understand the procedural challenge, a detailed account of the history is required. I must record that the way in which the papers were provided for the court were not well designed to illuminate the issue, although shortness of time provides some mitigation. So does an error in the final form of Silber J's directions, where the learned judge's intention that there should be a "core" bundle became simply "court bundle" - in the event several bundles. The vital documents were scattered among the bundles. There were two chronologies, not agreed. Neither the skeleton arguments nor the chronologies referred to the pages of the bundles, although I am grateful to counsel for the Defendants for revising their chronology during the hearing to incorporate (most of) the page numbers. The process of assimilating the history and preparing a judgement has been significantly lengthened by the state of the papers.
- In 1994 the ACP reviewed dichlorvos and concluded that the weight of evidence presented at the time did not suggest that it was a carcinogenic risk to humans. The provisional approval granted to the Claimant was in 1997 (and I assume was subsequently renewed).
- In May 1998 the Minister announced a review by the ACP of certain pesticides, including certain organophosphates, among them dichlorvos. The review was to look at the chemicals with public safety and environmental protection issues uppermost in mind. In September 1998 the HSE issued to the Claimant and other approval holders Call-in Notices, requiring the submission by September 1999 of extensive data for the purposes of the "full review of dichlorvos". Under the heading "4.1 Mammalian Toxicity Studies on the Active Substance", there were requests for mutagenicity studies and in relation to carcinogenicity, lifetime feeding bioassay for carcinogenicity in two species where the use pattern was expected to produce high or moderate prolonged exposure. The Notices warned that action might be taken against product approvals inter alia if "when the data are examined by ACP, the risk cannot be established through lack of relevant data". The Claimant and some others duly gave notice that they would be supporting their products through the review.
- On 23 September 1999 the Claimant submitted to the HSE extensive data. It included data relating to 17 studies or reports on mutagenicity and four studies on carcinogenicity: an unpublished report by Blair and others (1974) on Two-year Inhalation Exposure of Rats to Dichlorvos Vapour; Toxicology and Carcinogenesis Studies on rats and mice of Dichlorvos (1989); a review of data and appraisal of the carcinogenicity of dichlorvos by WHO (1989); and an Evaluation of the Potential Carcinogenicity of Dichlorvos, Final Report of the Expert Panel (1998). In November 1999 Pletsa and others published a paper based on an in vivo study of mice, showing a statistically significant threefold increase in mutant frequency in the liver of mice injected with dichlorvos.
- Early in 2000 scientists of the Biocides and Pesticides Assessment Unit ("BPAU") of the HSE evaluated the various data, including that produced by the Claimant. Their evaluation was considered by the Interdepartmental Secretariat on 30 January. There was concern about anticholinesterase effects, because the relevant risk assessments suggested the possibility of adverse effects could not be excluded. The evaluation was referred to the ACP with a proposal to revoke approvals for aerosols and other products, including the approval held by the Claimant and those for other products supplied by the Claimant.
- A paper by Sasaki and others on a positive in vivo genotoxicity test for dichlorvos (Comet assay) (2000) was noted. The Comet assay is a technique for detecting DNA damage in cells. The paper reported positive carcinogenicity effects for dichlorvos. It was recorded that the HSE did not wish to change their position on the carcinogenic potential of dichlorvos at present, but would welcome the COM's interpretation of the data.
- Chapter 4 of the evaluation was sent to the Claimant on 1 February. It was invited to comment on the IDS proposal to revoke approvals in connected with the anticholinesterase effects, but it was not referred to the Comet assay paper.
- On 8 February the COM considered the Comet assay paper and decided that a full review of the mutagenicity data for dichlorvos was needed. BPAU was informed. On 12 February Ann Taylor of the Claimant telephoned Dr.Murphy of BPAU, pursuing requests for more time to comment on the risk assessments. There is a dispute about what was said. Dr.Murphy produces a detailed file note. There is a letter from Ann Taylor, the Claimant's Senior Regulatory Affairs Manager, to Dr.Murphy dated 13 February, which refers to the telephone conversation.
- They discussed the risk assessments and the review generally. According to Dr.Murphy she referred to the new in vivo genotoxicity data and to the COM's request to look at dichlorvos again. She says that Ann Taylor took details of the new genotoxicity paper and was going to forward it to Amvac toxicologists for comment. Ann Taylor asked what the implications were for approvals and was told that Dr.Murphy did not know at that stage, but that the ACP would have to look again at the rest of the genotoxicity and the carcinogenicity data. Ann Taylor's letter, having referred to the IDS recommendations, continues:
"We also discussed in our telephone conversation this morning [sic], the issue recently raised by … the COM at their meeting of 8 February 2001. I understand that they had reviewed a paper in which the in vivo mutagenicity of dichlorvos had been considered, and had given a positive response".
- The letter goes on to agree that the Claimant's database could be reviewed by the COM in order to investigate this finding further. It suggests that it would make sense if the ACP's review was postponed until after it had received the COM's comments on the genotoxicity issue. It mentioned a recent independent review of the genotoxicity of dichlorvos which would be relevant to the discussion of the COM.
- Ian Chart merely says that Ann Taylor has told him that she cannot recall carcinogenicity being mentioned and that she did not mention it to him in an e-mail. It seems likely that Dr.Murphy is correct about the telephone conversation, because of her file note. It is common ground that genotoxicity was mentioned. There is no denial of the assertion that Ann Taylor had been given details of the paper and indeed it is overwhelmingly likely that she would have asked for such details. In any event, the Claimant was clearly made aware of an important new paper, relevant to the review, and it was its own fault if it did not obtain a copy and seek the advice of its experts on it. The Claimant knew that the COM was to meet towards the end of April. The Defendants rely on these discussions as demonstrating that the Claimant was alerted to carcinogenicity as a live issue.
- There was parallel discussion about the anticholinesterase concerns of the ACP. The Claimant contends that these were to be distinguished from the concerns raised by the COM. I therefore look particularly at developments about the latter.
- On 2 March Dr.Murphy wrote to Ann Taylor, referring to the COM's decision that a full review of mutagenicity data on dichlorvos was required. Although carcinogenicity was not mentioned, full details of the Comet assay and another study (relevant to mutagenicity and genotoxicity) were enclosed. On 27 March Ann Taylor wrote to Dr.Murphy about the review of the mutagenicity data by the COM. She said:
"I attach a list of the mutagenicity and carcinogenicity studies that we submitted for the recent UK review which are therefore relevant to the COM's review and which we trust have been summarised".
The list included three of the four studies listed by the Claimant in September 1999.
- The Chairman of the ACP was Professor David Coggon, Professor of Occupational and Environmental Medicine at the Medical Research Council Environmental Epidemiology Unit at the University of Southampton. The Deputy Chairman was Professor Alan Boobis, Professor of Biochemical Pharmacology at the Royal Post-Graduate Medical School in the University of London. The membership of about 15 included experts in biology, agriculture, pest management, environmental science and related fields.
- I bear in mind that the minutes of the committees in due course were made public.
- On 5 April the ACP met. Members noted that dichlorvos was to be considered at the next meeting of the COM on 26 April. They agreed that they would re-examine their recommendations in the light of the COM's discussions and take a final decision on dichlorvos at the next ACP meeting. The Chairman raised the question of potential carcinogenicity of dichlorvos and the forestomach tumours observed in mice. The Deputy Chairman considered that the weight of evidence indicated that dichlorvos was unlikely to pose a carcinogenic hazard in humans, but would wish to take into account the views of the COM with regard to the substance's mutagenicity. Recommendations were made about revocation and suspension of certain products containing dichlorvos, but it was noted that these recommendations might require modification at the next meeting, following discussion by the COM.
- The Claimant and other approval holders were informed by letter on 6 April of the recommendations of the ACP and were asked to note that the mutagenicity of dichlorvos was to be considered by the COM on 26 April.
- On 26 April the COM considered the data on mutagenicity. Dr.Murphy telephoned Ann Taylor the next day to give her brief details and to warn that a statement was being prepared, which would require comments in 3 or 4 days. On 4 May a draft version of a resulting statement was sent to the Claimant (which says it received it on 7 May). The COM noted the various mutagenicity studies, including the Plesta study in 1999. Members noted some limited evidence for a carcinogenic effect in animals from standard bioassays in rats and mice using gavage dosing. They considered that it was not possible to exclude a genotoxic effect. They concluded that dichlorvos should be regarded as an in vivo mutagen, producing mutagenic effects in the skin at the site of contact and in systemic tissues when repeated doses were administered. They agreed that no threshold for the activity of dichlorvos could be assumed. Among the papers listed among the references was a comment by Amvac on the Comet assay study.
- On 11 May, having been refused further time, the Claimant submitted its comments. It said that there was additional information it wished to be considered by the ACP and the COM and said that it was inappropriate to allow less than 30 - 60 days for comments. It said that further details would follow. In short, the Claimant submitted that a definitive conclusion on the mutagenicity of dichlorvos was prevented by the limitations of existing studies. It was further stated that carcinogenicity studies should be fully considered (including the 1974 Blair study, which tended to negative carcinogenicity). However, it is to be noted that the Claimant's response was addressing mutagenicity.
- The Chairman of the COM considered the request for more time. As a result the Claimant was told that the COM would review its conclusions on mutagenicity at its July meeting and give the Claimant an opportunity to present its arguments then.
- On 30 May, following a meeting of the ACP on 24 May, a notice was sent to the Claimant and other approval holders. It was similar in form to that of 5 April, although recommendations were added. However, mutagenicity was referred to in these terms:
"PLEASE NOTE ALSO THAT THE MUTAGENICITY OF DICHLORVOS IS TO BE CONSIDERED BY THE COMMITTEE ON MUTAGENICITY ON 23 JULY, 2001. AT THIS STAGE THE ACP WILL TAKE COM's VIEWS INTO ACCOUNT FOR PRODUCTS CONTAINING DICHLORVOS".
- On 20 June a pre-meeting took place between Ann Taylor and Ian Chart of the Claimant, BPAU (including Dr.Murphy) and others. After some discussion, the note of the meeting reads:
"The relationship between mutagenicity and carcinogenicity of dichlorvos was discussed. It was noted that the COM were not carcinogenicity experts. This issue would be considered by the ACP when they addressed the risks to users from products. AMVAC informed the COM secretariat that the US EPA had recently downgraded their classification of dichlorvos for carcinogenicity and considered the tumours seen in the carcinogenicity studies were not relevant to humans. It was noted that whilst the COM and ACP would form their own opinions, it would be interesting to see the reasoning behind the US EPA change of opinion. AMVAC agreed to provide this".
The reasoning was not in fact provided.
- The Claimant then moved on to the ACP review of dichlorvos. The reasons for the ACP's decision to make certain recommendations when the COM review was still going on were discussed. The note continues:
"AMVAC enquired who would consider the risks to users if the COM did not change their opinion that dichlorvos was an in vivo mutagen at the site of contact. They were informed that the ACP would look at the risks from specific products. With regard to carcinogenicity, it was possible that the ACP would seek advice from the COC. BPAU considered that the ACP would find it difficult to justify a recommendation to retain approval for consumer products if the COM opinion did not change".
- The note of the meeting suggests that carcinogenicity was raised as a live issue. Ian Chart's statement asserts a different understanding, namely that the Claimant raised carcinogenicity on the basis that negative evidence about carcinogenicity was relevant in demonstrating dichlorvos was not an in vivo mutagen. He states that he was left with the clear message that the COM were concerned only with mutagenicity and not with carcinogenicity. In other words, the Claimant regarded the more recent evidence about carcinogenicity as helpful to their case. It had, so it is said, no reason to think that carcinogenicity was a positive concern.
- The Claimant sent further comments to Dr.Murphy on 28 June. They were clearly directed towards mutagenicity. There were exchanges of e-mails about the late submission of further material.
- On 13 July approval holders were notified of the Ministers' response to the recommendations of the ACP in a letter headed:
"REVIEW OF ANTICHOLINESTERASE COMPOUNDS: PARTIAL REVIEW OF DICHLORVOS".
The letter added:
"PLEASE NOTE THAT THE MUTAGENICITY OF DICHLORVOS IS TO BE CONSIDERED BY THE COMMITTEE ON MUTAGENICITY ON 23 JULY, 2001. AT THIS STAGE THE ACP WILL TAKE COM'S VIEWS INTO ACCOUNT FOR PRODUCTS CONTAINING DICHLORVOS WHICH MAY RESULT IN FURTHER REGULATORY ACTION".
- The ACP met on 19 July. The minutes include the following:
"The Chairman indicated that it was important to be clear about the possible additional risks that would be of concern if dichlorvos were an in vivo mutagen. These related to reproductive toxicity and carcinogenicity. … DH suggested that with long term exposure the main concern would be carcinogenicity at the site of skin contact i.e. skin or the gastrointestinal tract. They did not consider exposure via inhalation to be of so much concern because of the absence of tumours in the inhalation carcinogenicity study that had been submitted.
There was further discussion specifically about carcinogenicity, in the course of which Professor Boobis emphasised that even if COM were to conclude that dichlorvos was a genotoxic carcinogen the risk to consumers from exposure would be very low. The Food Standards Agency expressed the view, however, that consumers would not accept any exposure to genotoxic carcinogens from approved food chemicals such as pesticides. The comment was made that the occurrence of forestomach tumours in mice was related to prolonged exposure to dichlorvos. Professor Boobis noted that as the COM conclusion would be available to the public, the ACP would have to present their conclusions clearly. I have little doubt that this reminder that any mention of any possibility of carcinogenic effects would be made public had an effect on the speed of subsequent events. It is to be noted that the Chairman had raised the question of carcinogenicity on 5 April and had wished for the view of the COM. However, the COM in its first draft statement following the 26 April meeting had not concluded that there were concerns about carcinogenicity.
- The ACP agreed to advise the Minister of the following:
"5.6.10. If COM concluded that dichlorvos was an in vivo mutagen, and could not exclude the possibility that the occurrence of tumours in animal tests of carcinogenicity resulted from a genotoxic mechanism, there should be immediate revocation of all uses (both agricultural and non-agricultural). This should include re-call of stocks from the supply chain for products used in both the amateur and professional areas. This advice would be given as a precautionary measure, since the possibility of human genotoxic carcinogenicity could not be excluded. The Committee agreed that any risk of human carcinogenicity was likely to be very small, and would be mainly associated with certain uses in the home and with exposures to some operators in the agricultural sector. The consumption of produce already treated with dichlorvos (sourced from within or outside the UK) would not raise the same level of concern since the levels of dietary exposure (based on food residues monitoring data) were considered minimal.
"5.6.11. If COM concluded that dichlorvos was an in vivo mutagen, but that the tumours observed in animal tests did not result from a genotoxic mechanism, or if they could not confirm that dichlorvos was an in vivo mutagen, or they took the view that dichlorvos was not an in vivo mutagen, the Committee's previous recommendations would not require modification".
- On 13 June 2001 Dr.Sandy Kennedy, a member of the COC, had written a letter about two studies on the carcinogenicity of dichlorvos: the 1989 study, which had been referred to by the Claimant in their submitted data and a 1977 study. The latter was a bioassay of dichlorvos for possible carcinogenicity by the National Cancer Institute in the United States. The letter was before the COM on 23 July.
- The COM met on 23 July. The agenda had been published on the internet, although I have not been provided with a copy. Professor Boobis attended as an observer. There was discussion about the mutagenicity of dichlorvos and in particular the Comet assay. There was then a presentation by the Claimant and others from the industry, "with experts in mutagenicity assessment acting as consultant", lasting about 30 minutes, at which questions were asked. The industry team were not made aware of what the ACP had decided on 19 July. The discussion on carcinogenicity as such took place after the industry team had left. The COM concluded:
"… that dichlorvos should be regarded as an in-vivo mutagen at the site-of-contact. High doses of dichlorvos induced mutagenic effects in the skin following topical application and in the liver following intraperitoneal dosing. The Committee agreed that dichlorvos induced tumours of the forestomach in mice after gavage dosing; also that the oesophageal tumours seen after dietary administration were probably related to dichlorvos treatment. The Committee felt that it would be prudent to assume a genotoxic mechanism on the basis of the available data. The Committee agreed that in the absence of appropriate mechanistic data a precautionary approach should be adopted and no threshold could be assumed for the mutagenic and carcinogenic effects of dichlorvos".
- It is clear that the COM were seeking to respond to the questions referred to it by the ACP.
- Early on 24 July the COM secretariat sent to the Claimant by e-mail a "second amended draft" of the COM statement on mutagenicity of dichlorvos. The Claimant had received a previous draft dated 4 May. In the new draft new material was helpfully highlighted. The new material included, most importantly, the matters raised at the ACP meeting on 19 July and discussed in the industry team's absence at the COM meeting on 23 July. Among the listed references annexed to the new draft were the 1977 and 1989 studies mentioned by Dr.Kennedy in his letter of 13 June (which the Claimant had not seen). Those studies had not been listed in the annex to the May draft. The Claimant was given until lunchtime on 26 July to comment.
- Later on 24 July an e-mail was sent by Dr.Murphy to Ann Taylor. She warned that the proposed time scale for regulatory action would be short. The Claimant then asked about the possibility of producing data to identify whether there was a threshold for the mutagenic and carcinogenic effects of dichlorvos. Dr.Murphy replied, with some suggestions about what might be needed, and invited the Claimant, before commissioning studies, to submit a protocol for consideration by the ACP, demonstrating how the Claimant would demonstrate what it sought. She also pointed out that any new data was unlikely to affect the revocations already agreed (affecting 45 out of 48 currently approved products) based on anticholinesterase effects. No protocol was in fact submitted.
- Amvac wrote with comments on 26 July and again on 31 July, on the latter occasion enclosing comments from a toxicologist. On 31 July the Claimant's solicitors also wrote, challenging in detail the proposed decisions. On 25 July Susan Popple, Director of Policy of the PSD, first saw the Minister about recent developments. She submitted a paper to him on 27 July, setting out the options and recommending revocation of the relevant approvals. In the light of representations on behalf of the Claimant she wrote to the Minister again on 1 August, recommending suspension rather than revocation. On 3 August the Claimant's solicitors wrote again, asking for more time to submit evidence. On 4 August the Claimant was informed of the intention to announce on 6 August the suspension of approvals.
The procedural challenge: conclusions
- I have already noted that it is common ground that mutagenicity and carcinogenicity (and genotoxicity) may be closely related. I also accept that genotoxicity and carcinogenicity may be linked. Carcinogenicity was clearly within the scope of the review as a whole. I accept that it was specifically raised in February.
- The Claimant's case has developed. It was initially contended that carcinogenicity was never raised as a regulatory issue. At the hearing an argument was raised that had not found a place even in the Claimant's skeleton: that the Claimant was not alerted to the fact that the two "mouse" studies of 1977 and 1989 were being considered. They had themselves listed the 1989 study in September 1999 and the 1977 study would be known to any experts they consulted.
- Nevertheless it is clear on a careful analysis of the history that the ACP's consideration of dichlorvos took on a new and urgent dimension on 19 July. That dimension related to genotoxicity and carcinogenicity. What happened was that the ACP and then the COM considered the implications of concluding that dichlorvos was an in vivo mutagen. The views of Dr.Kennedy were considered. The two studies of 1977 and 1989 were considered in the new context. New and urgent advice resulted. The very urgency with which the conclusions of the COM on 23 July were treated is in fact inconsistent with the Defendants' argument that nothing new had emerged the Claimant could and should not have anticipated and commented on. I am not considering the substantive merits of the decisions that resulted.
- No allegation of bad faith has been made. It is surprising that the Claimant was only alerted to the new dimension on 24 July and hence remained in ignorance during the COM meeting on 23 July. Of course its experts were not the most appropriate to deal with the new dimension. The time then given for comment was extremely short.
- Was there justification for giving such a very short time for comment? The additional risks identified were on any view not high. I infer that what gave rise to the perceived urgency was the fact that once carcinogenicity was raised, and following the COM meeting became public, there was likely to be public concern. Professor Boobis in effect pointed this out on 19 July.
- Bearing in mind that the substance of the decision is not under challenge, I consider that the Defendants were entitled to look at the matter as one of urgency. Quite apart from the level of actual risk, they were entitled to bear in mind public concern and public confidence in the regulatory system. This justifies not referring the matter back to the ACP, as had been expected on 20 June.
- The criticism that the matter was not referred to the COC, apart from obtaining Dr.Kennedy's letter, goes in my view to the substantive issue that is not before the court.
- Having read the documents, I do not consider that the material submitted to the Minister by Susan Popple is open to criticism. The advice that "officials agree with the ACP that the possibility of serious health risks make it necessary to take immediate action" is criticised as overstating the risk. I remind myself that there is no challenge to the substantive decision before me, but in any event any risk of cancer could properly be described as a "serious health risk"; the phrase was not directed towards the magnitude of the risk.
- Nor do I consider that the Claimant was entitled to see that advice to Ministers. However, there was a failure by those concerned on the Defendants' side to inform the Claimant promptly after 19 July of the new and urgent dimension to the consideration being given to dichlorvos. Until then the review had been proceeding at a measured pace and the Claimant had been kept informed of developments. To alert them only on 24 July was an error. And then no one seems to have given consideration to the time needed for comment by the Claimant. It was given about 48 hours (until 26 July), with recommendations going to the Minister on 27 July. It is true that consideration was given after that to representations on behalf of the Claimant, which resulted in advice on 1 August to suspend rather than revoke.
- Even if one takes the period for comment as effectively from 24 July to 31 July, that was too short. There was a failure to give proper consideration to how long a consultation period should be. There was a failure to notify the Claimant on 20 July of what had already become potentially urgent. Even if 20 days (less than the period given for final submissions on the other aspect of the review) had been allowed from 20 July, an urgent timetable could have been maintained. The Claimant might have raised further arguments even on 23 July, although it says that the experts it had were not the ones it would have needed. As it was the Claimant had assembled and filed material from experts by the time of Mr.Chart's statement on 14 July.
- It is submitted that the material filed from Dr.Karel de Raat, Dr.John Ishmael and Dr.John Mennear would have made no difference to the advice given or to the decisions made. I do not think I can reach that conclusion. The committees were not faced with overwhelming new evidence of an obvious risk. They were on any view assessing what weight to give to a risk of a more modest nature arising from old and newer information. I do not consider that the court is in a position to conclude that if the additional material had been taken into account, the decision would necessarily have been the same.
The precautionary principle
- The Claimant does not contend that the Defendants were necessarily under any duty to follow the precautionary principle. Essentially its case is that the Defendants purported to do so, but failed.
- The precautionary principle, as defined at the 1992 Rio Conference on the Environment and Development, requires that:
"Where there are threats of serious or irreversible damage, lack of full scientific certainty should not be posed as a reason for postponing cost effective measures to prevent environmental degradation".
- It is self-evident that the principle itself, as stated above, would not assist the Claimant - rather the reverse. What the Claimant says is that if measures are to be taken in the absence of full scientific certainty, there must necessarily be a proper assessment of risk, since it would be absurd to take measures simply because the absence of any risk could not be completely excluded. Rarely is it possible to prove a negative.
- The Claimant must in effect show three things. First, it must show that mechanisms were in place, as part of the application of the precautionary principle, to carry out an appropriate risk assessment. Secondly, it must show that the Defendants purported to follow the principle and its ancillary mechanisms. Thirdly, it must show that there was a failure to follow such mechanisms.
- I have been referred by Counsel for the Claimant to various documents.
- In 1998 the UK Official Group on Organophosphates reported to Ministers, following a Ministerial assurance in the House of Lords that the Government would consider further the precautionary principle, as distinct from risk analysis. The Group noted that the precautionary principle was entrenched in Article 130r of the EU Treaty as the basis for EU environmental measures, but was not defined there or elsewhere in EU or UK legislation. The Group said:
"It is not surprising therefore to find the expression is used with various meanings. In current discussion of [organophosphate] products we detected two main views of the precautionary principle:
"A the principle that where a hazard is identified, risks of harm from the hazard should be assumed for the purposes of control measures to be significant pending proof to the contrary;
"B the principle that reasonable grounds are needed for concluding that a hazard gives rise to a significant risk of harm, but that where the likelihood of harm arising cannot be accurately calculated: -
(a) the uncertainty should not be regarded as a valid reason for inaction;
(b) the likelihood should be assessed to be on the higher side of the range of possible predictions; and
(c) control measures should be put in place accordingly".
- The Group concluded, in the "Conclusion" at 6.32 under the heading "Veterinary medicines" that precautionary principle A "is not applied now and is not compatible with present legislation (UK and EU)". In its "Conclusion" at 6.38 under the heading "Pesticides" the Group said:
"We concluded that the advantages to human health and to the environment that would be delivered by a precautionary approach are deliverable under [the Act and Regulations] and under Directive 91/414, both in respect of the granting and the revocation of approvals again by use of precautionary principle B as part of the procedure; and that this forms part of current practice".
- Counsel were not able to tell me what, if any, Government response there was to the Group's 1998 report.
- In May 1999 the Department for Environment, Food and Rural Affairs, issued a Strategy on Sustainable Development entitled A better quality of life, with a foreword by the Prime Minister. Having referred to the precautionary principle, the document continues:
"The precautionary principle means that it is not acceptable just to say we can't be sure that serious damage will happen, so we'll do nothing to prevent it". Precaution is not just relevant to environmental damage - for example, chemicals which may affect wildlife may also affect human health.
"At the same time, precautionary action must be based on objective assessments of the costs and benefits of action. The principle does not mean that we only permit activities if we are sure that serious harm will not arise, or there is proof that the benefits outweigh all possible risks. That would severely hinder progress towards improvements in the quality of life.
"There are no hard and fast rules on when to take action: each case has to be considered carefully. We may decide that a particular risk is so serious that it is not worth living with. In other cases society will be prepared to live with a risk because of other benefits it brings. Transparency is essential: difficult decisions on precautionary action are most likely where there is reason to think that there may be a significant threat, but evidence is as yet lacking or inconclusive. Decisions should be reviewed to reflect better understanding of risk as more evidence becomes available".
- In February 2000 came the Communication from the EU Commission on the precautionary principle. It is the most detailed statement recommending how the principle should be applied that I have been referred to. I have read it and shall refer to it again.
- In 2000 also came the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. The protocol deals with the import of living modified organisms, not with pesticides. Although the word "precautionary" does not appear, Article 10.6 states that lack of scientific certainty shall not prevent the taking of a decision on such import. Article 15 deals with risk assessment.
- In August 2000 the Government published its Response to the Sixth Annual Report of the Government Panel on Sustainable Development. Having referred back to the May 1999 strategy, the Response states:
"The Government strongly supports the expression of the precautionary principle contained in the Biosafety Protocol on Biological Diversity. We also welcome the European Commission's recent Communication on the Precautionary Principle which outlines the Commission's general approach to using the precautionary principle across Community policies and provides a useful contribution to the debate on the application of the precautionary principle. The Communication stresses the need for precautionary measures to be: proportional, non-discriminatory, consistent, based on an examination of the potential benefits and costs, subject to review, and capable of assigning responsibility for producing the necessary scientific evidence. The approach is broadly consistent with that set out in the UK Strategy for Sustainable Development, and we look forward to further discussions of the Communication under the French Presidency" (my italics).
- In December 2000 there was a resolution of the EU Council of Ministers, noting that Article 174(2) of the EC Treaty recognises that the precautionary principle is one of the principles to be taken into account in Community policy on the environment and also noting that the principle is applicable to human health. The Council welcomed the Commission's initiative in presenting its Communication, "the broad lines of which the Council endorses" (my italics). It continued:
"3. [The Council] notes that the precautionary principle is gradually asserting itself as a principle of international law in the fields of environmental and health protection". …
"6. Sees a need to establish guidelines for use of the precautionary principle, in order to clarify arrangements for its application" (my italics).
- The Council resolution goes on to express further opinions about the factors to be taken into account.
- Interestingly, it so happened that the ACP held an open meeting on 18 July 2001 at which the chairman, Professor Coggon, tabled a paper The Precautionary Principle and Pesticide Regulation dated June 2001. Having referred to the definition set out at Rio, he continued:
"What the principle does not state is how strong the suspicion of a threat should be before action is taken. To act on any suspicion or doubt, however small, would amount to a requirement for full scientific certainty that there was no threat of serious or irreversible damage. This would be just as unrealistic as requiring full scientific certainty of the existence of a hazard".
- Professor Coggon pointed out that the Principle focuses only on environmental degradation, while decisions in the regulation of pesticides can impact on health as well as the environment. He then proceeded to discuss the matter further.
- A briefing note for the same meeting contained references to the 1998 Report to Ministers and the Communication from the EU Commission.
- I have also been referred to the report Use of Risk Assessment within Government Departments (undated) by the Interdepartmental Liaison Group on Risk Assessment, in which there is some discussion of the precautionary principle.
- I have been referred to two cases in which the precautionary principle was considered. In R. v. Leicester City Council and others, ex parte Blackfordby and Boothorpe Action Group Ltd. [2000] JPL 1266, Richards J. referred at paragraphs 65 to 68 to a submission based on the precautionary principle "briefly advanced and again plucked out of the air in the course of oral argument, that the decision was Wednesbury unreasonable in its application of the principle …". Richards J. said that it was difficult to see precisely how counsel relied on the principle, in the field of planning and waste management. In the end he held that it did not take the arguments any further. In R. (on the application of Murray) v. Derbyshire County Council, 6 October 2000, Maurice Kay J. dealt with similar submissions in the same field of regulation. After a limited discussion of the principle, he held that the submission added nothing to a submission based on the relevant regulations and that in any event he was unable to find that there was a failure to have regard to the principle in any event.
- I am prepared to accept that on a substantive challenge to a regulatory decision, it may in some fields of regulation be relevant to take into account the precautionary principle and, more important, its limitations. It may be relevant to refer to the principle in a substantive challenge in the field of pesticide approval. However, my very firm conclusion is that there is - at least so far - no settled, specific or identifiable mechanism of risk assessment in the field of pesticide approval that the Claimant is entitled to rely on as part of the "precautionary principle", viewed as a separate basis for challenging a decision. I have reviewed the principal sources on which the Claimant seeks to rely. However, to my mind the Claimant's submissions founder when it is realised that the ACP was discussing at its open meeting on 18 July 2001 how the principle might be applied in this field, in the light of an interesting and helpful, but far from definitive paper by Professor Coggon. Counsel were unable to tell me whether any firm decisions emerged from that open meeting.
- By that I do not mean that the Defendants can ignore the need to assess any risk and to proceed on a rational basis. However, the substantive challenge to the decision is not the subject of permission.
- In any event I do not consider that the Defendants or their advisory bodies purported in relation to the present decision to apply the precautionary principle as a term of art or any settled, specific or identifiable mechanism or methodology. The ACP referred to a "precautionary measure" and the COM to a "precautionary approach". The decision letter dated 4 August contains a similar reference. I accept that in using such language they were probably influenced by the discussion of the precautionary principle over the last few years. However, I do not consider that they were purporting to adopt any particular mechanism.
Article 1 of the First Protocol
- Article 1 reads:
"Every natural or legal person is entitled to the peaceful enjoyment of his possessions. No one shall be deprived of his possessions except in the public interest and subject to the conditions provided for by law and by the general principles on international law.
The preceding provisions shall not, however, in any way impair the right of a State to enforce such laws as it deems necessary to control the use of property in accordance with the general interest or to secure the payment of taxes of other contributions or penalties".
- The Claimant's first hurdle is to demonstrate that an approval falls within the protections accorded to "possessions". I have been referred to three decisions of the European Court of Human Rights. I note straight away that of these, Agneessens v. Belgium (1988) 58 DR 63 is a decision of the Commission in which it is accepted that the ownership of a debt can constitute a possession. In may be that the Claimant intended to refer to Van Marle v. Netherlands (1986) 8 EHRR, in which it was held that in some circumstances goodwill may be a possession.
- In Tre Traktörer Aktiebolag v. Sweden (1989) 13 EHRR 309, the Court was considering the withdrawal of a licence to serve alcohol in a restaurant managed by the applicant. The Court found that the maintenance of the licence was one of the principal conditions for the carrying on of the applicant's business and that its withdrawal had adverse effects on the goodwill and value of the restaurant. The withdrawal of the licence was in the circumstances an interference with the applicant's peaceful enjoyment of its possessions.
- In Fredin v. Sweden (1991) 13 EHRR 784 the permit in question was a permit to exploit a gravel pit. The Court found - indeed it was not contested before it - that the revocation of the permit interfered with the applicants' right to the peaceful enjoyment of their possessions, including the economic interests connected with the exploitation of the gravel pit.
- These two authorities each involved a licence or permit to use a building or site in a particular way. The Claimant's counsel was not able to refer me to any authority for the extension of the protection to a regulatory approval to market a product. Undoubtedly such approvals may have economic value to a person or company. The withdrawal of such approval may have serious economic effects. It is surprising, if Article 1 is engaged where there is a withdrawal of such an approval, that no such claim has apparently previously been made.
- The Defendants point out that the legislation and regulations do not require that approvals be issued to individual companies. However, my understanding is that in practice this is what is invariably done.
- It seems to me that the Claimant's argument should be considered in three stages. First, can Article 1 ever be engaged in relation to a regulatory approval? In other words, can such an approval ever be a "possession"? Secondly, was the provisional approval "not to be marketed" held by the Claimant such a "possession"? Thirdly, were the Claimant's economic interests in the approvals held by others possessions?
- The first of these questions seems to me not straightforward, although I am inclined to the view, in the absence of direct authority, that a regulatory approval cannot be a "possession" for this purpose. However, the point was argued relatively shortly.
- I am, however, firmly of the view that an approval of the qualified kind held by the Claimant cannot be a "possession". In reaching this conclusion I bear in mind the reasoning in the European Court decisions, where the withdrawal of the licence had a direct economic effect on the use by the applicant of its property. The suspension of this approval (assuming that a suspension can amount to a deprivation) does not have any direct economic effect on the Claimant. They are really concerned about the future marketing of dichlorvos generally.
- I am very firmly of the view that economic interests in the other approvals cannot amount to a "possession". If the term could be applied as widely as that, many with commercial interests in a particular market could raise similar arguments. That extension in my judgement goes far beyond the scope of Article 1.
- For completeness I have considered the arguments set out in paragraph 165 of the Claimant's skeleton argument and confirmed orally, if briefly, that, if Article 1 is engaged, the regulatory response was not proportionate and did not strike a fair balance. I do not accept those arguments. On the evidence available the response was not so flawed, particularly when the decision was to suspend and not to revoke.
Conclusions
- The Claimant fails on the issues relating to the precautionary principle and Article 1.
- I have found that the decision was procedurally flawed in relation to the amount and length of notice given to the Claimant. I accept that the decision was modified to the extent that approvals were suspended rather than revoked. Nevertheless I consider that the decision should be quashed. I invite counsel's assistance in formulating an order.
- The court in not criticising the substance of the decision, based on the material available at the time it was taken. The court is in effect criticising the lack of a reasonable opportunity to add to that material.
- I have borne in mind that the matter is urgent, since, if the decision was correct, it was correct to take it urgently. The Claimant has now in effect had a full opportunity to present such material as it wishes to present. No further time is necessary. The Defendants will have to consider whether some limited opportunity be given in relation to any other approval holders. Subject to that, I see no reason why those advising Ministers should not review their advice, taking into account all the Claimant submits, without significant delay. Similarly, the Ministers can consider what, if any, action to take in the light of such advice without significant delay.
