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Oshlack v Rous Water - preliminary ruling

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Australian ruling sets new challenge to British government’s fluoride plans.
5th May 2011

Does an order to fluoridate a public water supply stand alone, or must it recognise
other legislation that may apply?
Doug Cross

Over the past decade I have argued that fluoridated water is legally a medicine, even though it is not licensed as such. Therefore, its supply to the public must comply with the medicinal laws of Britain and the EC. Now an Australian Court has ruled that an order to fluoridate a public water supply cannot enjoy unfettered application. It must instead comply with other legislation that may require the practice to be modified in order to avoid prohibitions established by legislation dealing with other arms of the law.

The result of a preliminary hearing before Mr. Justice Peter Biscoe in the New South Wales Land and Environment Court was announced last week. He ruled against arguments by Rous Water and Ballina Shire Council that the Australian legislation on water fluoridation should be regarded as ‘unfettered’ - that is, that it stood alone and that no other legislation can obstruct or modify it.

Finding for Al Oshlack, a legal representative for the Indigenous Justice Advocacy Network, Justice Biscoe said that the Fluoridation of Public Water Supplies Act 1957 and the Fluoridation of Water Supplies Regulation 2007 specified the technical means whereby water is to be fluoridated. Entirely independently, the Environmental Planning and Assessment Act of 1979 (EPA) prohibited the release to the environment of any substance that is likely to have a significant adverse effect.

What is the argument about?

These two branches of Australian law deal with quite different aspects of the activity of adding fluoride ('fluorine' in the Australian legislation) to drinking water. Fluoridation law deals specifically with the technical aspects governing the production of a consumable product, fluoridated water. The environmental legislation sets out the general requirements for protecting the environment from damaging contamination. The two sets of laws are therefore not mutually inconsistent, and both must be obeyed.

Justice Biscoe’s ruling means that before a company fluoridates its product it must first demonstrate that no protected and potentially vulnerable environmental component will be affected. But crucially, the EPA states that
"environment includes all aspects of the surroundings of humans, whether affecting any human as an individual or in his or her social groupings". So an Australian water company planning to introduce fluoridation now has to produce a detailed Environmental Impact Statement (EIS) showing that any discharge of its product to the environment - and therefore including its supply to the public - will not have any adverse effects.

The difference between a direction and approval to fluoridate a water supply.

Under the fluoridation law in New South Wales there are two actions available to the Director of Health when a new fluoridation project is planned. He may issue a direction to a water supplier to fluoridate its drinking water supply, and since this is a legitimate instruction, that direction must be obeyed - it is a criminal offence to fail to do so.

Alternatively, a company may seek an approval to fluoridate, but may then decide not to implement the approval if some technical or other factor shows that doing so would result in the development of an unacceptable or insuperable problem.

Rous Water and Ballina Shire Council, the respondents in this case, are now in a difficult position. Rous Water has been directed to fluoridate the water supplied to the Richmond Valley area, and has been granted approvals for the Lismore and Ballina plants, whilst Ballina Shire Council has an approval to fluoridate water provided by the Marom Creek plant.

In last week’s ruling by Justice Biscoe, the respondents learned that they must comply with the EPA in addition to the fluoridation legislation. They must therefore now provide a fully detailed EIS for the development before they convert their water treatment plants to be able to fluoridate the local water supplies.

But whilst the existing
approvals could be abandoned if the EIS reveals an obstacle, the direction from NSW Health to Rous Water to fluoridate the Richmond Valley supply must be obeyed, regardless of any obstacle that may then arise that may be in conflict with the terms of the EPA. No matter how seriously fluoridation may affect either the environment or the public, the direction must be obeyed.

What level of Environmental Impact Statement is required?

In the run-up to this confrontation Rous Water prepared a ‘Review of Environmental Factors’ (REF) in accordance with the rules on the preparation of plans for water treatment works developments, which are exempt from the EPA. But in an old decision by Justice Gillard, back in 1964, the equipment needed to fluoridate drinking water was ruled not to be an essential part of the water treatment plant itself, and therefore is not exempt from planning regulations. Instead it falls entirely within the scope of public health, and not water supply.

This latest ruling means that any EIS for a proposed fluoridation project will now have to comply with the standard format and scope of assessments that have been adopted internationally. In particular, since the specific objective of the production of fluoridated water is to affect the health of consumers, a detailed Health Impact Assessment (HIA), as specified in the Australian Guidelines on HIA, must be included in the EIS.

And since the definition of ‘environment’ also includes impacts on human social groupings, the EIS must also include a Social Impact Assessment, to determine the social and financial effects on individuals in fluoridated communities who are adversely affected, both physically and psychologically. These include, but are not limited to, the effects of the disfigurement of fluorosed teeth and the huge costs to individuals who wish to conceal such damage through remedial cosmetic dental treatment.

But where more serious effects occur, and even death, the impacts of these on victims and their social groups will also need to be quantified and proposals provided for their avoidance or, at the very least, their reduction and the mitigation of any residual adverse effects.

Testing the evidence - is fluoridation really ‘safe and effective’?

Now, the next stage of this case will be held before the Court in Sydney in June. Al Oshlack will argue that Rous Water’s existing REF is void and of no value. Rous Water will have to provide expert evidence on the probable impacts on the natural environment and on human communities supplied with fluoridated water, and both sides have commissioned affidavits from internationally respected experts, and the Court will rely on these to test the two sides' arguments.

And that is when this challenge will become very interesting indeed. The evidence that fluoridation causes human diseases, some of which, like osteosarcoma, can be fatal, is now overwhelming. Such impacts certainly exceed the threshold at which the EPA prohibitions on environmental damage becomes relevant. So the next hearing will force the proponents of fluoridation to prove, instead of merely to assert, that the practice has no adverse effects on the environment or on people.

In the past, fluoride advocates have attempted to justify this practice by claiming that it provides an acceptable trade-off between dental decay in children and the lifetime disbenefits of dental fluorosis. But this foundation for fluoridation has never been subjected to the level of detailed cross-examination that will be applied by Al’s legal team in the Sydney Courtroom.

The perfunctory cost-benefit analyses that have so far been included in feasibility studies for new projects have never incorporated the full range of social and economic costs that have to be born by those in the community who suffer from fluorosis or other clinical problems caused by chronic fluoride poisoning. So this coming interrogation of some of the world’s leading pro-fluoride proponents will set a notable precedent.

For Rous Water, for New South Wales’s fluoridation policy, and indeed for all fluoridation operations in Australia, last week’s ruling poses a huge problem. If Al Oshlack wins this case in June, then Rous Water and Ballina Shire Council must provide an EIS that takes full account of the evidence that will be provided in the coming hearing. If this shows potential conflict with the EPA, then Rous Water and Ballina Shire Council will, if necessary, be able to propose to abandon the projects that have already been approved. Or they may try to devise some modification of their project that will prevent exposure of vulnerable groups, whether natural, human, or both, to their product.

On the horns of a dilemma - compromise or face criminal charges.

But for Rous Water in particular, the specific
direction to fluoridate Richmond Valley water poses a far greater immediate problem. Since the power to order a water supplier to fluoridate is established under the fluoridation legislation it is legal, so it must be obeyed. The Richmond Valley project must be implemented, but only in a manner that does not present any threat to vulnerable components of the natural environment, or to the public.

And that is where things get really difficult. For if the evidence shows that the project will have significant adverse effects, it will have to be modified to ensure that vulnerable ecology or people are not exposed to the water. The only way to avoid all such damage is, of course, not to add fluoride to the water - but that would be a criminal offence!

The solution?

There is only one form of compromise that I can imagine that would permit Rous Water to comply with both arms of the law. The acknowledged ‘target’ of the practice is the human consumers of water in the Richmond Valley, and especially young children, and the legislation does not explicitly require that ALL of the company's water must be fluoridated.

It would therefore appear to be possible to suggest a compromise, by narrowing the delivery of the product to the specific target population - there is no claimed ‘need’ nor justification to fluoridate water that is used for other purposes. So, in order to comply with both arms of the law Rous Water might propose to fluoridate only that proportion of its product designed to be directly consumed by the residents of the Richmond Valley, leaving the rest of the supply unfluoridated.

(There is a precedent for a similar solution in Europe. In Aalsmeer in The Netherlands the City's water supply was fluoridated. But in response to strong objections from the public and local doctors, in 1972 standpipes providing unfluoridated water were placed at selected locations for those who demanded unfluoridated water. The inconvenience was so great that this ill--considered dual supply scheme soon collapsed. Fluoridation in The Netherlands ended a few years later.)

The fluoridated water provided by Rous Water to the residents of Richmond Valley would, of course, have to be supplied only in bottles or cartons, to avoid accidental consumption by non-target or vulnerable individuals, as well as to prevent any significant spillage or discharge to the environment. The containers of fluoridated water would have to be clearly labelled, to warn vulnerable individuals not to drink the contents. In fact, the product would then have to be supplied just as if it were a medicine - which is exactly what we have been arguing for all along!

Whether the partial fluoridation of a water supply would be acceptable to NSW Health is open to debate, but this is the only compromise that I can imagine that would permit Rous Water to obey both the fluoridation and the environmental constraints placed on them by the Commonwealth of Australia legislature and by that of the State of New South Wales. Other water suppliers, and other States within that Commonwealth, will have to take note and decide just how to respond to this ruling, since by implication it could affect human customers of water suppliers across the nation.

Applying the principles of Oshlack v Rous Water elsewhere

The specific prohibition on permitting adverse environmental effects on vulnerable communities, both natural and human, that is set out in the Australian Environmental Planning and Assessment Act, is not mirrored precisely elsewhere, although most frameworks of environmental law include more or less similar provisions.

Al Oshlack's use of the Australian EPA has been effective because it provides a clear instance of an unrelated branch of law that could, and by necessity must, be invoked to force an otherwise potentially hazardous activity to be modified to prevent a foreseeable unacceptable violation. But other legislative frameworks can also apply, and can be used in a similar fashion elsewhere. For example, in the EC and the UK two arms of the law that could be selected for a similar challenge are those regulating foods and medicines.

Fluoridation and food law.

The key factor in the Rous Water case is that fluoridation legislation merely establishes the technical procedures involved in the manufacture of fluoridated water. In effect, it is a ‘cook-book’ for water suppliers, with specific instructions on how to produce and manage their product.

But as an ingestible product, fluoridated water is also subject to the general EC and national legislation that deals with the supply of consumer products such as foods and medicines. So fluoridated water must be supplied to the public in compliance with relevant consumer law.

Drinking water is a food, and it is argued by the British regulator of medicines, the Medicines and Healthcare Products Regulatory agency (MHRA), that fluoridated water is not a medicine - if this were to be the case (although in fact it is not - see later) then it would be required to comply with food law, and specifically with the Drinking Water Directive 98/83/EC.

In the UK the fluoridation legislation includes a requirement to use fluorosilicic acid or its sodium salt to add the supposed mineral, fluoride to drinking water. This was most recently confirmed in the Water Act 2003. However, under European law on the addition of vitamins, minerals and other substances to foods, no unregistered source material may be used for fluoride other than sodium or potassium fluoride.

Interested parties in any Member State who wished to continue to use an unorthodox source material (and this includes fluorosilicates) to add any scheduled substance to a food had until 19th January 2010 to submit an application for approval by the EC, but no such application for fluorosilicic acid or its sodium salt to be authorised was ever submitted. Therefore the continued use of fluorosilicates in foods - and that includes drinking water - was effectively banned from that date.

Since both the fluoridation legislation and that on the addition of minerals to foods deal with activities within the food sector, the most recent Directive applies, and the fluoridation provisions of the Water Act 2003 in UK law are invalidated by the new Directive. So, as from 19th January 2010, all fluoridation law in the UK was rendered obsolete and dormant. It must now either be amended in compliance with the Directive or else repealed.

Fluoridation and medicinal law.

I have long argued that, since the objective of fluoridating drinking water is to attempt to prevent children developing the disease of dental caries, the product must be classed as a medicinal water. As such it is excluded from the legislation on drinking water, and indeed, from all food law also. It is no longer a food - instead it is subject solely to medicinal law.

Medicinal law requires that any substance or product that is described as having any medicinal property (regardless of whether it actually has) must first be assigned a relevant medicinal licence - in the UK, a 'marketing authorisation' issued by the MHRA - before it can be placed on the market. It is a criminal offence to supply any unlicensed medicinal product, and even to claim that it has a medicinal property.

Medicinal law is entirely separate from fluoridation law, so there is no conflict between them - the fluoridation ‘cook-book’ specifies the production process, whilst the medicinal law specifies the conditions for its supply to the public. Both must be obeyed.

So as a result of the decision in Oshlack v Rous Water and Others, whilst a water company is obliged to comply with an order to fluoridate under the Water Act 2003, it must also ensure that the supply of the product complies with the Medicines Act 1968 in its licensing, advertising and supply to the general public. And as in the case of Rous Water, UK water companies will now have to find a compromise that allows them to comply with the two arms of the law, and it appears that the same solution provides the only possible solution.

Since it is aimed to supply the product to every member of the community, including those most vulnerable to fluoride over-dose, the evidence in an application for a medicinal licence must clearly show that there is an adequate safety margin that prevents harm to vulnerable customers. When - and only when - a licence has been granted, the applicant must then supply the fluoridated product in containers labelled in compliance with the medicines legislation.

The English fluoridation law, like that of Australia, must be obeyed, but the constraints of medicinal law must also be complied with. So it is for water providers to find a solution that will enable them to comply with both arms of the law. We look forward to learning how those British water companies that are presently fluoridating their product resolve this interesting dilemma, and how those facing an order to commence fluoridation respond to any Strategic Health Authority (or its planned successor, Public Health England) that issues such an order.

The application of the European Directive on liability for environmental crime.

As a footnote to this ruling, it is worth bearing in mind that in Article 3 of Directive 2008/99/EC on the protection of the environment through criminal law requires all Member States of the EC to treat as a criminal offence
"the discharge, emission or introduction of a quantity of materials or ionising radiation into air, soil or water, which causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to animals or plants", whilst Article 4 further states that "inciting, aiding and abetting the intentional conduct referred to in Article 3 is punishable as a criminal offence." (my emphasis added)

Significantly, discharging any such material into water for human consumption is quite specifically also prohibited, since the 208/99/EC applies to the Drinking Water Directive, 98/83/EC.

If the expert evidence in Oshlack v Rous Water confirms that the addition of fluoride - in any form -to drinking water causes any person to suffer death or serious injury as a result, then water suppliers throughout the EC, whether in the private of public sector, will become liable to prosecution.

Bearing in mind the extensive evidence of the medical damage that fluoridation is now known to cause to consumers, and especially Bassin’s findings on a very significant increase in the prevalence of frequently fatal osteosarcoma in fluoridated water areas, those advocating, endorsing or assisting in the practice of water fluoridation may be regarded as accessories to criminal offences under the terms of this Directive, and may be subject personally to criminal and civil liability.

Wider application of the Oshlack v Rous Water judicial review.

Although this judicial review is taking place in far-away Australia, its implications are already travelling around the world. The decision of Justice Biscoe in Sydney in June will affect the future welfare of millions who are presently forced to consume this unwanted and dangerous product at the whim of a tiny but vociferous band of fluoride fanatics.

It seems probable that the Court will indeed decide that the evidence that allowing fluoridated water to discharge to "the environment" is in breach of the Environmental Planning and Assessment Act’s prohibition, since it can be reliably demonstrated that this results in significant adverse effects on the environment and/or human communities. If this is the case, then the evidence of the dangers of the practice must be respected by Health Departments and Administrations around the world.

Whilst challenges elsewhere may now rely on different arms of law than the environmental challenge utilised by Al Oshlack, judges must now take note of the Land and Environment Court’s decision and consider all arguments against the practice in the light of all those arms of law that restrict the unfettered application of fluoridation law. This really could, at last, spell the end of water fluoridation.

For the official ruling of Justice Biscoe,

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