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You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> AMVAC Chemical UK Ltd, R (on the application of) v Secretary of State for Environment, Food & Rural Affairrs & Ors [2001] EWHC Admin 1011 (3rd December, 2001) URL: http://www.bailii.org/ew/cases/EWHC/Admin/2001/1011.html Cite as: [2001] EWHC Admin 1011 |
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IN THE HIGH COURT OF JUSTICE No. CO/3087/2001
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Royal Courts of Justice Strand, London WC2A 2LL | ||
B e f o r e :
____________________
THE QUEEN on the application of AMVAC CHEMICAL UK LIMITED and (1) SECRETARY OF STATE FOR ENVIRONMENT, FOOD AND RURAL AFFAIRS (2) SECRETARY OF STATE FOR TRANSPORT, LOCAL GOVERNMENT AND REGIONS and FOOD STANDARDS AGENCY
Smith Bernal Reporting Limited, 190 Fleet Street
London EC4A 2AG
Tel No: 020 7421 4040, Fax No: 020 7831 8838
Official Shorthand Writers to the Court)
Mr.Richard McManus QC and Mr.Philip Coppel appeared for the Defendants.
Mr.Philip Coppel appeared for the Interested Party
____________________
Crown Copyright ©
MR JUSTICE CRANE:
The issues
(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?
Hearing in private
"The general rule is that a hearing is to be in public".
"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".
"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 regulatory regime
"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".
Terminology
The Claimant and dichlorvos
The procedural challenge: the history
"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".
"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.
"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".
"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.
"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".
"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 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.
"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".
"… 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".
The procedural challenge: conclusions
The precautionary principle
"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 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".
"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".
"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".
"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).
"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).
"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".
Article 1 of the First Protocol
"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".
Conclusions