For over a decade I was on the faculty of the University of Colorado School of Medicine where I was one of the leading experts in carcinogenesis from radiation and toxic chemicals. I was appointed by the Governor and senior Senator of Colorado to monitor the Rocky Flats Nuclear Weapons plant and as Chair of the Health Effects Committee was reviewing toxicology reports on a wide variety of chemicals as well as radiation on a weekly basis for many years.
I was also the Co-Chair of the leading committee on healthcare standards for many years and attended workshop after workshop with members of the FDA and CDC. When I would complain about issues like the one below I was repeatedly informed that these organizations were continuously buffeted by political pressure which influenced all their actions. They said they had much bigger problems with political influence than the ones I had identified.
Here is a short excerpt of some toxicology concerns that indicate infants are getting fluoride far above the EPA upper limit. As an expert in this area, my view is that there is no safe dose of fluoride, only a dose like the EPA limit where most adults will not have obvious clinical symptoms.
The government has been repeatedly been convicted of destroying evidence, obstruction of justice, harassing scientists and fraudulent suppressing or altering the data in official reports on fluoride hazards. The appeal courts have refused to overturn the governments objections to being ordered in court to stop their criminal behavior and reinstate senior scientists who have been abused. Watch Fluoridegate for testimony on government officials forced to lie when setting standards.
The government has been repeatedly been convicted of destroying evidence, obstruction of justice, harassing scientists and fraudulent suppressing or altering the data in official reports on fluoride hazards. The appeal courts have refused to overturn the governments objections to being ordered in court to stop their criminal behavior and reinstate senior scientists who have been abused. Watch Fluoridegate for testimony on government officials forced to lie when setting standards.
The Basics of Regulatory Toxicology: Protecting the Public from Harmful substances
By Paul Connett
So many of the statements and arguments coming from proponents of fluoridation betray their lack of knowledge of basic toxicological principles especially as it is applied in the regulatory field. It is one thing when such poorly informed positions emanate from lay persons but quite another when it comes from pediatricians or people at the very top of large organizations promoting fluoridation.
Here is one shocking example. The appalling toxicological ignorance of the American Dental Association (ADA) was demonstrated when it dismissed the relevance of the landmark review by National Research Council of the National Academies (NRC) on the very day it was published in 2006. The same ignorance was displayed by the CDC Oral Health Division six days later. Both organizations argued that the NRC (2006) was not relevant to water fluoridation because the panel (they claimed) only looked at harm in communities with fluoride levels between 2 and 4 ppm. There are four major problems with this position:
a) The NRC panel looked at several studies in which harm was found at less than 2 ppm
b) Chapter 2 of the NRC (2006) review consisted of an exposure analysis that concluded that certain subsets of the US population (including bottle-fed babies) drinking water at 1 ppm were exceeding the US Environmental Protection Agency’s (EPA’s) safe reference dose for fluoride (0.06 mg/kg/day).
c) Neither the ADA or the CDC Oral Health Division appears to realize that there is a difference between concentration and dose. When comparing two populations and considering whether a certain concentration is safe or not one must first calculate the dose involved. This depends on how much water is consumed. As far as a harmful dose is concerned there will be an overlap between the doses ingested by individuals when comparing two communities – one drinking water at 1 ppm fluoride and one drinking water at 4 ppm – and even more so when comparing 1 ppm and 2 ppm. This overlap will occur even before we consider individuals exposed to other sources of fluoride. It is the total daily dose that is the critical calculation as far as harm is concerned. So both the ADA and CDC are incorrect when they imply there is a margin of safety simply because harm has been found at a higher concentration (in the studies cited by the NRC) and not necessarily at the 1 ppm used in water fluoridation.Concentration is not an appropriate basis for comparison as far as toxicity or safety is concerned.
d) They also ignored the need to use a safety factor when extrapolating from small studies to estimate a safe dose needed to protect everyone in a large population.
I will now go into more detail on these issues below.
The difference between concentration and dose.
Concentration is measured in milligrams (mg) of fluoride per liter (1 mg/liter = 1 part per million or ppm). This can be controlled at the water works. Dose is measured in mg/day and this cannot be controlled as it depends on how much someone drinks – and some drink a lot – and how much fluoride they are getting from other sources. It is the total dose that has the potential to harm someone. The concentration (mg/liter) offers no guarantee of safety. It is actually worse than that, which brings us to part b) above.
The difference between dose and dosage.
The same dose (mg/day) can have different affects on different people. There are two reasons for this:
1) because in a large population there is a large range of sensitivity to any toxic substance (more about that later) and
2) because the same dose can have a very different affect on people of different bodyweights. This is especially relevant when comparing the impacts of the same doseon adults and infants. That is why toxicologists use a different measure called dosage. In this they take account of bodyweight by dividing the dose in mg/day by the adult’s average bodyweight of 70 kg.
Thus supposing it was determined that 7 mg/day was safe for an adult (for some health end point), then the safe dosage (sometimes referred to as a safe reference dose) which can be applied to anyone of any weight including an infant, would be 0.1 mg/kg bodyweight per day. 7mg/day divided by 70 kg = 0.1 mg/kg/day
Going from safe dosage to safe dose for a particular bodyweight
From a safe dosage we can work out a safe dose for any age range by multiplying the safe dosage by the average bodyweight for that age range. Thus for a 7 kg infant the safe dose for this hypothetical situation would be 0.7 mg/day and for a 20 kg child it would be 2 mg/day.
The EPA’s Iris Reference Dose (Dosage)
Going back to the real world. The (EPA) determined a safe reference dosage (for the end point of moderate dental fluorosis) of 0.06 mg/kg/day (the so-called IRIS reference dose). Using this Iris reference dose we can determine the safe dose for a bottle-fed infant – at least for dental fluorosis. Assuming an average bodyweight of 7 kg, the safe dose would be 7 kg x 0.06 mg/kg/day = 0.42 mg/day.
A 7 kg infant drinking 800 ml of formula per day made up with fluoridated water at 1 ppm, would receive 0.8 liters x 1 mg/liter/ day = 0.8 mg/day. In other words a bottle-fed baby consuming water at 1 ppm fluoride would get about twice the safe dose based upon the EPA’s IRIS safe reference dose.