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June 02, 2009

Subject: Fluoridation of Drinking Water

RE: SCHER Fluoridation -call for information.

Sir/Madam,

SCHER is not fit for the purpose of risk assessing fluoridated drinking water.

Since the purpose of fluoridating drinking water in the EU is prophylactic, scientific risk assessment must be conducted on the basis of principles and (clinical) procedures appropriate to products with a prophylactic function.

The existing membership of SCHER is lacking in the expertise appropriate to such an assessment, consisting as the committee does, of experts in environmental- and eco-toxicity. The minutes of the 1st Working Group (WG)on 12th May 2009 has already identified the need for SCHER to co-opt anexternal expert on dentistry and one on fluoride physiology, however the minutes did not state if such external experts are available from the appointed Pool of scientific experts as required by Article 4 of Decision 2008/721/EC on the advisory structure of scientific committees.

While recognition of these two gaps in the committee's expertise is indeed significant, nevertheless we fundamentally question the capacity of SCHER even after these two co-options, to deliver a proper scientific risk assessment of fluoridated drinking water given the complexity and extremelywide variety of the physiological effectsof fluoridated drinking water on human and animal health.

Proper risk assessment of the physiological effects would require the addition of extensive expertise in fluorosis (dental & skeletal) in developmental toxicity, in neuroscience including brain and IQ effects , in endocrinology including pineal gland effects , in thyroid function, in osteopathology including bone cancer , in nephrology, and in effects on the gastrointestinal tract, immune system, reproduction, respiratory function and include allergic/hypersensitive effects.

Annex II of Commisison Decision (2009/146/EC) of 20.02.2009 appointing members of scientific committees and the Pool of experts pursuant to Decision 2008/721/EC , does not appear to include the necessary expertise either in dentistry or fluoride physiology. Furthermore to provide the necessary range of expertise such as that brought to bear by the contributors to the NRC Report 2006, the number of experts required from the Pool would infringe Article 3 of Decision 2008/721/EC which permits no more than five to be associated by SCHER to the committee. This would further weaken the capability of SCHER to deliver scientific advice based on the 'principles of excellence, independence, impartiality and transparency in conformity with best practice' that are required in the EU.

Under Annex I of Decision 2008/721/EC SCHER's 'field of competence is related to health and environmental risks related to pollutants in the environmental media .and other biological and physical factors that may have a negative impact on health and the environment.. for example airquality, waters, waste and soils, as well as on life cycle environmental assessment.

SCHER's field of competence does not extend to clinical and physiological assessment of pharmacologically active substances.

Since the minutes of the WG meeting of 12th May did not indicate the presence/absence of the committee's chair and/or vice-chairs, we conclude that the WG has not reviewed the significance for water fluoridation of the conclusions of the NRC Report,2006. When full assessment of this report is completed, it will become clear that the resources available to SCHER are completely inadequate for the task assigned to it by the Commission.

It also strikes us as unusual that the WG could have agreed the new (and final) mandate at its first meeting only a few days after the Commission received 97 separate comments on its working mandate and, in parallel, a substantial volume of information in 524 articles and reports and 8 books.

As doctors, we do not accept that the terms of reference for risk assessment of fluoridated drinking water given by the Commission to SCHER satisfy the essential clinical requirements for pharmacologically active substances. These are that they should be safe and effective after clinically conducted trials, and the quality and dissemination of information about these substances to citizens must be such as to enable them to make informed choices about their own treatment.

We can not envisage any circumstances in which the terms of reference assigned to SCHER for scientific risk assessment of fluoridation of drinking water could contribute to helping citizens in the EU make informed choices about the issue.

Sincerely

Dr Philip Michael
Vice President [Europe],
International Society of Doctors for the Environment
Millbrook Medical Centre,Bandon,
Co Cork
Ireland

Fluoride in Drinking Water : a Scientific Review of EPA Standards, National Research Council (2003-2006).
http://www.fluoridealert.org/health/epa/nrc/index.html

The minutes of the WG meeting. http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_miwg_002.pdf

Decision 2008/721/EC on Scientific committees.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:241:0021:0030:EN:PDF

The Committee members and the Pool of Experts.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:049:0033:0042:EN:PDF