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Letter from Merilyn Haines - Chair

Queenslanders For Safe Water, Air and Food Inc

PO Box 149 Archerfield 4108  

26 June 2009  
 

Dear Members of the Australia- New Zealand Food Regulation Ministerial Council 

cc ANZFRMC Secretariat

cc FSANZ Standards Management Officer / Parliamentary Liaison Officer

cc  CEO Australian Beverages Council Ltd 
 

The Hon Nicola Roxon, Hon Mark Butler, Hon Tony Burke, Hon Kate Wilkinson, Hon Ian Macdonald, Hon John Della Bosca, Hon Daniel Andrews, Hon Joe Helper, the Hon Paul Lucas, Hon Tim Mulherrin, Hon Murray Watt,  Hon John Hill, Hon Paul Caica, Hon Dr Kim Hames, Hon Terry Redman, Hon Lara Giddings, Hon Konstantine Vatskalis, Ms Katy Gallagher 

cc Ms Kirsten Hall,  Ms Cathie Humphreys, Mr Tony Gentile  
 

Dear Ministers  

Currently you are considering the approval or rejection of the voluntary addition of fluoride to bottled water. On behalf of Queenslanders For Safe Water, Air and Food Inc I write on a matter requiring your urgent consideration in regard to this.  

We wish to advise you that the advice provided to you by Food Standards Australia New Zealand is incomplete and inadequate in regards to the risk that fluoride may pose to vulnerable members of society, particularly those members of the community who have the medical disability of impaired kidney function. 

A recent communication from FSANZ, 4 June 2009, stated   

In the development of the Final Assessment Report, FSANZ undertook a robust and extensive assessment of the public health and safety implications of the Application.  The risk assessment concluded there is a history of safe use of fluoride in reticulated drinking water at the same levels as in the Application.  In addition, there was no evidence of any adverse effects or risk for any vulnerable sub-population groups from current levels of water fluoridation or dietary intakes in Australia or New Zealand.”  
 

On 16 June 2009 FSANZ further advised that “The potential for complications with kidney functions formed part of this investigation.  FSANZ’s primary source of information regarding the effects of fluorides on kidneys was a report published by the World Health Organization (WHO) in 2002 titled ‘Fluorides: Environmental Health Criteria 227’.  The WHO 2002 report specifically investigated human exposure to fluorides (Section 8 of the document), and found no evidence of significantly adverse haematological, hepatic or renal effects”  

However, examination of the 2002 WHO EHC 227 document shows that it does not provide any information on the cumulative effects of fluoride ingestion on those with kidney impairment and to date FSANZ has not provided any further information. The only  references to kidney function  in the 2002 WHO document are in relation  to workers in a Chinese aluminium smelter (1983 paper)  and patients on an osteoporosis trial (1987 paper) not being seen to have their kidney function impaired by being exposed to fluoride by inhalation or ingestion ( it is noted however that 6% of the 183 osteoporosis patients withdrew because of side effects)  
 

The question put to FSANZ about fluoride’s effect on vulnerable members of the community was not, “does fluoride cause kidney damage”, but, “what it is the effect of fluoride on those with kidney damage”, which is a completely different issue.  

FSANZ has not provided any evidence of any studies conducted which have looked at the effects of fluoride on those with Kidney impairment.

Please be advised that fluoride can and does pose a potential risk to vulnerable sub-population groups such as those with Kidney impairment, Kidney Disease and Diabetes which will often lead to Kidney Impairment. Aboriginals would be at particular risk because of their very high rates of kidney disease.

The National Health and Medical Research Council (NHMRC) in their 2004 Australian Drinking Water Guidelines( ADWG) has acknowledged that fluoride poses a risk to those with kidney impairment with it’s statement

  “ People with Kidney impairment have a lower margin of safety for fluoride intake. Limited data indicate that their fluoride retention may be up to three times normal”

The NHMRC 2007 review of Fluoride , which is being used a safety reference for fluoridation , cannot be used as proof of safety for vulnerable sub-groups of the population as the NHMRC has not looked at the effect of fluoride on those with Kidney impairment , nor has it looked at the effect of fluoride on Thyroid impairment.

Documents obtained under the Freedom Of Information Act proves that the NHMRC 2007 Review was to look at the effects of fluoride on people with kidney impairment. This was a Tender requirement.

Not only did the NHMRC NOT REPORT on the issue that fluoride poses a risk to those with kidney impairment, but any reference to it was also removed from the NHMRC statement of support brochure after 2 Dentists and 2 Water Quality specialists reviewed. 

Please be advised that Queensland Health has recently confirmed that Qld Health has not done a health risk assessment for fluoridation and that Qld Health has relied solely on the NHMRC 2007 Fluoridation Review as a risk assessment. Qld Health is currently gearing up to fluoridate 16 Queensland Indigenous communities despite not doing a Health Risk Assessment and despite being made aware that fluoridation poses a risk to those with Kidney impairment. Australian Aboriginals appear to be predisposed  to developing Kidney Disease, much more than non-Aboriginals, thus fluoridation may be particularly discriminatory to Aboriginals should a Health Risk Assessment confirm that they are increased risk from fluoridation.

The individual State and Territory reports of the 2004-2006 National Adult Oral Health Survey were published in August 2008 by the Australian Research Centre for Population Oral Health; and looking at the tooth decay data for all Australian States, it can be seen that there is no difference in adult oral health in Queensland (with less than 5% fluoridated water at that time ) compared to all the other states that have been heavily fluoridated for up to 50 years. Fluoridation cannot be justified on this. Recent Australian children’s dental surveys also cannot justify fluoridation for children when the World Health Organisation’s  recommended standard comparator of permanent teeth at age 12 years is employed, as little difference in children’s tooth decay is seen between fluoridated and non-fluoridated areas.

On the results of recent dental surveys, Fluoridation of bottled water is thus hard to justify on the “need” to reduce tooth decay, or on desire. Most of Australia has fluoridated public water supplies, this has usually occurred without public consent.

With all of Queensland now being subjected to forced fluoridation, 4 million potential customers who may have desired fluoridated water are now in the process of having their public water supplies fluoridated.

Fluoridated bottled water will provide little, if any benefit to public health, thus it is a matter of conjecture that its benefit could mostly be for trade.

FSANZ has recently been criticised in the media for placing trade ahead of public health   (“The threat facing our foodThe Australian 25/6/09 )”

FSANZ’s claim that there is no risk to vulnerable members of the community cannot be justified on what FSANZ has put forward to justify their claim. Vulnerable members of the community may be put at risk by FSANZ’s actions.

Ministers, we request that you do not do give approval for FSANZ to allow the voluntary  addition of fluoride to bottled water until a risk assessment  has been conducted detailing the  effects of fluoride on those more who are more  vulnerable, in particular,  members of the community who have kidney impairment.

NHRMC has not provided any information or evidence to prove that there is no risk to people with Kidney impairment and to date neither has FSANZ.

Ministers, now that you aware that an appropriate  risk  assessment on vulnerable members of the community , particularly those with Kidney impairment  has not been conducted, you would be negligent in your duty of care if you gave approval to FSANZ to allow the voluntary addition of fluoride to bottled water, without requesting both a First Review of FSANZ’s decision and also an A grade Health and Safety Study to look  at potential risk to vulnerable subsets of the population.

We await your advice.

Respectfully yours

Merilyn Haines

Chair, Queenslanders For Safe Water , Air and Food Inc    
 

A little more information about possible effects of fluoride on kidney impaired.

National Kidney Foundation ( NKF )  Admits: Kidney Patients Should be Notified of Potential Risk from Fluorides  and Fluoridated Drinking Water <http://fluoridealert.org/press/nfk2.html>  - The Lillie Center, June 3, 2008   

From the NKF statement  June 2008,…. 2. Specific recommendations regarding fluoride intake in CKD ( Chronic Kidney Disease)  patients are not possible based on available limited data. The current evidence regarding fluoride exposure and risks is comprised of case reports, case series, and extrapolations that assume exposure is directly proportional to water fluoride levels. There are no randomized trials of fluoride exposure for individuals with CKD. Additional research on the risks and extent of fluoride exposure for the potentially susceptible population of CKD patients with impaired kidney function is recommended

 

 Effects of fluoridation of community water supplies for people with chronic kidney disease Nephrology Dialysis Transplantation 2007 22(10):2763-2767; doi:10.1093/ndt/gfm477  published online on July 27, 2007 by  Marie Ludlow1, Grant Luxton2 and Timothy Mathew1 1Kidney Health Australia, Adelaide, South Australia and 2Sir Charles Gairdner Hospital, Nedlands, Western Australia

On the basis of the available evidence, Kidney Health Australia has developed the following position statement regarding fluoridation of community water supplies ( EXTRACT) 

….”There is consistent evidence that impairment of kidney function results in changes to the way in which fluoride is metabolized and eliminated from the body, resulting in an increased burden of fluoride

There is no evidence that consumption of optimally fluoridated drinking water poses any health risks for people with CKD, although only limited studies addressing this issue are available

There is limited evidence that people with stage 4 or 5 CKD who ingest substances with a high concentration of fluoride may be at risk of fluorosis 

Monitoring of fluoride intake and avoidance of fluoride-rich substances would be prudent for people with stage 4 or 5 CKD, in addition to regular investigations for possible signs of Fluorosis”……  

Fluoride & the Kidneys - Kidney Patients at Increased Risk of Fluoride Poisoning:  
 
"[A] fairly substantial body of research indicates that patients with chronic renal insufficiency are at an increased risk of chronic fluoride toxicity. Patients with reduced glomerular filtration rates have a decreased ability to excrete fluoride in the urine. These patients may develop skeletal fluorosis even at 1 ppm fluoride in the drinking water... The National Kidney Foundation in its ‘Position Paper on Fluoride—1980’ as well as the Kidney Health Australia express concern about fluoride retention in kidney patients. They caution physicians to monitor the fluoride intake of patients with advanced stages of kidney diseases. However, a number of reasons will account for the failure to monitor fluoride intake in patients with stages 4 and 5 of chronic kidney diseases and to detect early effects of fluoride retention on kidneys and bone. The safety margin for exposure to fluoride by renal patients is unknown, measurements of fluoride levels are not routine, the onset of skeletal fluorosis is slow and insidious, clinical symptoms of this skeletal disorder are vague, progression of renal functional decline is multifactorial and physicians are unaware of side effects of fluoride on kidneys or bone." 
SOURCE: Schiffl H. (2008). Fluoridation of drinking water and chronic kidney disease: absence of evidence is not evidence of absence. Nephrology Dialysis Transplantation 23:411. 
 
"Individuals with kidney disease have decreased ability to excrete fluoride in urine and are at risk of developing fluorosis even at normal recommended limit of 0.7 to 1.2 mg/l." 
SOURCE: Bansal R, Tiwari SC. (2006). Back pain in chronic renal failure. Nephrology Dialysis Transplantation 21:2331-2332.  
 
"Persons with renal failure can have a four fold increase in skeletal fluoride content, are at more risk of spontaneous bone fractures, and akin to skeletal fluorosis even at 1.0 ppm fluoride in drinking water."SOURCE: Ayoob S, Gupta AK. (2006). Fluoride in Drinking Water: A Review on the Status and Stress Effects. Critical Reviews in Environmental Science and Technology 36:433–487  
 
"In patients with reduced renal function, the potential for fluoride accumulation in the skeleton is increased. It has been known for many years that people with renal insufficiency have elevated plasma fluoride concentrations compared with normal healthy persons and are at a higher risk of developing skeletal fluorosis."SOURCE: National Research Council. (2006). Fluoride in Drinking Water: A Scientific Review of EPA's Standards <
http://www.fluoridealert.org/health/epa/nrc/index.html> . National Academies Press, Washington D.C. p140 .  
 
"We hypothesize that elevated serum F levels might contribute to the disturbances in mineral ion homeostasis that are observed in patients with CRI [Chronic Renal Insufficiency]. This is of particular concern since the incidence of dental fluorosis has increased due to increased F– uptake from multiple fluoridated sources. The ubiquitous presence of F in food and beverage products regardless of the degree of water fluoridation suggests that the overall F exposure in individuals with CRI may need to be more closely monitored." 
SOURCE: Mathias RS, et al. (2000). Increased fluoride content in the femur growth plate and cortical bone of uremic rats. Pediatric Nephrology 14:935–939 
 
“It is important to control the intake of this element [fluoride] and the prolonged use of fluoridated dental products in the subjects with chronic renal insufficiency, to avoid a risk of fluorosis.” 
SOURCE: Torra M, et al. (1998). Serum and urine fluoride concentration: relationships to age, sex and renal function in a non-fluoridated population. Science of the Total Environment 220: 81-5. 
 
"[A] fairly substantial body of research indicates that people with kidney dysfunction are at increased risk of developing some degree of skeletal fluorosis. ... However, there has been no systematic survey of people with impaired kidney function to determine how many actually suffer a degree of skeletal fluorosis that is clearly detrimental to their health." 
SOURCE: Hileman B. (1988). Fluoridation of water. Questions about health risks and benefits remain after more than 40 years. Chemical and Engineering News August 1, 1988, 26-42.  
 
"It seems probable that some people with severe or long-term renal disease, which might not be advanced enough to require hemodialysis  can still experience reduced fluoride excretion to an extent that can lead to fluorosis, or aggravate skeletal complications  associated with kidney disease... It has been estimated that one in every 25 Americans may have some form of kidney disease; it would seem imperative that the magnitude of risk to such a large sub-segment of the population be determined through extensive and careful study. To date, however, no studies of this sort have been carried out, and none is planned." SOURCE: Groth, E. (1973). Two Issues of Science and Public Policy: Air Pollution Control in the San Francisco Bay Area, and Fluoridation of Community Water Supplies. Ph.D. Dissertation, Department of Biological Sciences, Stanford University, May 1973. 
 
"It would not be surprising if there were some undetected cases of skeletal fluorosis  in the Australian population in individuals with pathological thirst disorders and/or impaired renal function. However, the matter has not been systematically examined. This matter should be the subject of careful and systematic review." SOURCE: National Health and Medical Research Council. (1991). The effectiveness of water fluoridation. Canberra, Australia: Australian Government Publishing Service.
 
 
"Though fluorosis is prevalent in certain geographic parts of the world, it is likely to occur in other parts... in people with latent kidney disease even when they consume relatively lower amounts of fluoride than in endemic regions." SOURCE: Reddy DR, et al. (1993). Neuro-radiology of skeletal fluorosis. Annals of the Academy of Medicine, Singapore 22(3 Suppl):493-500. 
 
"Impairment of renal function can prolong the plasma half-life and contribute to clinical toxicity at lower concentrations of fluoride intake." SOURCE: Fisher RL, et al. (1989). Endemic fluorosis with spinal cord compression. A case report and review. Archives of Internal Medicine 149: 697-700. 
 
"Persons with chronic renal failures constitute a possible group at-risk with respect to the occurrence of skeletal fluorosis, because of an increased fluoride retention after oral intake. Based on the results of one study, in which the difference in retention between nephritic patients and healthy persons was quantified (average retention: 65% and 20%, respectively), a total daily intake of about 1.5 mg appears to be the maximum acceptable intake for nephritic patients. In view of the limitations of this comparative study and of the individual differences in retention and sensitivity, this figure must only be regarded as an indication."SOURCE: National Institute for Public Health and Environmental Protection. (1989). Integrated criteria document fluorides. Report No 758474010. The Netherlands. 
 
"The skeletal complication  of fluoride is more common in renal disease. Because of the impairment in renal excretion of fluoride, high circulating concentrations of fluoride may be achieved in renal disease." SOURCE: Pak CY. (1989). Fluoride and osteoporosis. Proceedings of the Society for Experimental Biology and Medicine 191: 278-86. 
 
"Fluoridation of drinking water up to 1.2 ppm apparently does not pose a potential risk to bone provided the renal function is normal... We should, however, recognize that it is difficult to give a strict value for a safe fluoride concentration in drinking water, because individual susceptibility to fluoride varies."SOURCE: Arnala I, et al. (1985). Effects of fluoride on bone in Finland. Histomorphometry of cadaver bone from low and high fluoride areas. Acta Orthopaedica Scandinavica 56(2):161-6. 
 
"Because the kidney is the main pathway of fluoride excretion, patients with chronic renal failure are especially vulnerable to osseous accumulation of ingested fluoride and to potentially deleterious effects." SOURCE: Fisher JR, et al. (1981). Skeletal fluorosis from eating soil. Arizona Medicine 38: 833-5. 
 
"In the human body, the kidneys are probably the most crucial organ during the course of low-dose long-term exposure to fluoride. Healthy kidneys excrete 50 to 60% of the ingested dose (Marier and Rose 1971). Kidney malfunction can impede this excretion, thereby causing an increased deposition of fluoride into bone. Marier (1977) has reviewed data showing that, in persons with advanced bilateral pyelonephritis, the skeletal fluoride content can be 4-fold that of similarly-exposed persons with normal kidneys. Similarly, Mernagh et al. (1977) have reported a 4-fold higher skeletal fluoride content in persons with the renal failure of osteodystrophy. It has also been shown (Seidenberg et al. 1976; Hanhijarvi 1975) that plasma F- levels can be 3 1/2 to 5 times higher than normal in persons with renal insufficiency. It is thus apparent that persons afflicted with some types of kidney malfunction constitute another group that is more "at risk" than is the general population." 
SOURCE: Marier J, Rose D. (1977). Environmental Fluoride. National Research Council of Canada. Associate Committe on Scientific Criteria for Environmental Quality. NRCC No. 16081. 
 
"It is generally agreed that water fluoridation is safe for persons with normal kidneys. Systemic fluorosis in patients with diminished renal function, however, seems a reasonable possibility. In such patients, fluoride may be retained with resulting higher tissue fluoride levels than in persons with normal renal function." SOURCE: Juncos LI, Donadio JV. (1972). Renal failure and fluorosis. Journal of the American Medical Association 222:783-5. 
 
 
"The question of the effect of water containing 1 p.p.m. upon patients with severe impairment of kidney function requires special consideration in view of the fact that radiologic evidence of chronic fluorosis has been found in two persons with severe kidney disease who died at the early ages of 22 and 23 years, respectively..."SOURCE: Heyroth F. (1952). Hearings Before the House Select Committee to Investigate the Use of Chemicals in Foods and Cosmetics, House of Representatives, 82nd Congress, Part 3, Washington D.C., Government Printing Office, p. 28.  
 
"All patients with dental fluorosis  and anemia and/or signs of renal impairment should have radiographic examinations of the skeletal system to rule out the existence of fluoride osteosclerosis... It is likely that the reason our patient retained fluorine in his bones was that he had renal damage of long standing; without this the osteosclerosis might not have developed."SOURCE: Linsman JF, McMurray CA. (1943). Fluoride osteosclerosis from drinking water. Radiology 40: 474-484.  

…….MORE INFORMATION CAN BE SUPPLIED  

SOME FURTHER INFORMATION ON ABORIGINALS PROPENSITY TO KIDNEY IMPAIRMENT  

Australian Aboriginals have much higher rates of Kidney Disease than Caucasians; recent research indicates they are predisposed to developing Kidney Disease. People with Kidney Disease or Kidney impairment may be at increased risk from fluoridation, they may not tolerate it as well as healthy people.  Fluoridation may be discriminatory to Aboriginals. Fluoridated water, whether reticulated or bottled will pose a risk. 

Recent research indicates Australian Aboriginals on average, are born with fewer nephrons in their Kidneys, which may predispose them to developing Kidney Disease in later life, also to Hypertension which can lead to Kidney Disease. Aboriginals have much higher rates of Kidney Disease than caucasions and also have much higher rates of Diabetes, which if not well controlled, leads to Kidney disease. 

Based on recent data, Indigenous Australians were 6 times more likely as other Australians to be receiving dialysis or to have had a kidney transplant. Death rates from chronic kidney disease were 7 and 11 times as high for non-indigenous males and females respectively. Chronic kidney disease contributed to nearly 10% of all deaths in Australia in 2006 and over 1.1 million hospitalisations in 2006-07. Risk factors for chronic kidney disease are highly prevalent in Australia and the number of Australians at risk is increasing. Indigenous Australians in particular are at high risk.

. (Media Release and  An overview of chronic kidney disease in Australia 2009) released 27 May 2009

The rate of diabetes is six times higher among indigenous people. It is estimated that diabetes affects between 10 to 30 per cent of the Aboriginal population. Although diabetes only affects a small number of Aboriginal people, diabetes–related mortality and morbidity rates are more than ten times those of the non-Aboriginal population  http://www.mmhr.org.au/Home.asp?documentid=342  WA Country Health Service  

Supplied below  # is an extract of one scientific paper documenting that Australian Aboriginals have fewer nephrons in their kidneys and indicating this puts them at increased risk of developing Kidney Disease. An Internet search can locate other research papers with similar findings.  

Fluoridation of Indigenous communities, whose residents may have very high rates of Diabetes and Kidney Disease may place Indigenous people at a higher risk of adverse health effects as people with Kidney impairment may be more susceptible to ingestion of fluoride  “ People with Kidney impairment have a lower margin of safety for fluoride intake. Limited data indicate that their fluoride retention may be up to three times normal”  Australian Drinking Water Guidelines 2004 – National Health and Medical Research Council  

Consumption of fluoride by those with kidney impairment, means that fluoride is not able to be excreted to the same extent as those with healthy kidney function, this means higher circulating plasma fluoride levels and increased storage in the body , 99% of stored fluoride is stored in bones but some is stored in the Pineal gland and possibly other organs.  

 

 #   Reduced nephron number and glomerulomegaly in Australian Aborigines: A group at high risk for renal disease and hypertension   Kidney International (2006) 70, 104–110. doi:10.1038/sj.ki.5000397; published online 24 May 2006 W E Hoy1, M D Hughson2, G R Singh3, R Douglas-Denton4 and J F Bertram4        http://www.nature.com/ki/journal/v70/n1/abs/5000397a.html

Extract ( emphasis added ) ......   “Aborigines in remote areas of Australia have much higher rates of renal disease, as well as hypertension and cardiovascular disease, than non-Aboriginal Australians. We compared kidney findings in Aboriginal and non-Aboriginal people in one remote region. Glomerular number and mean glomerular volume were estimated with the disector/fractionator combination in the right kidney of 19 Aborigines and 24 non-Aboriginal people undergoing forensic autopsy for sudden or unexpected death in the Top End of the Northern Territory. 

Aborigines had 30% fewer glomeruli than non-Aborigines – 202 000 fewer glomeruli per kidney, or an estimated 404 000 fewer per person (P=0.036).

The lower nephron number in Aboriginal people is compatible with their susceptibility to renal failure. The additional nephron deficit associated with hypertension is compatible with other reports. Lower nephron numbers are probably due in part to reduced nephron endowment, which is related to a suboptimal intrauterine environment”. ........

END 
 

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