FLUORIDE ACTION NETWORK
FAN Bulletin 1089: The public unprotected by the FDA, EPA and the CDC
August 27, 2009,
One would be hard put to choose among which federal agency violates scientific integrity more, the FDA, the EPA or the CDC. Each appears to put corporate interest above the public interest. I include the American Dental Association (ADA) in the description "corporate interest." The recent examples below fly in the face of President Obama's declaration that during his watch he would attempt to restore scientific integrity to federal regulatory agencies.
Example 1. The ADA and the mercury amalgam industry continues to pull strings at the FDA.
Please watch a three part interview between Dr. Mercola and Charlie Brown FDA's Mercury Ruling Defies ALL Scientific Reasoning.
Example 2. The CDC continues to aggressively promote fluoridation around the country.
See the latest travesty where an engineer, Kip Duchon- with no medical qualifications - is allowed to give the last word on the safety of fluoridation -in the attempt to step up fluoridation in the San Francisco Bay Area (see FAN bulletins #s 1087,1088). Remember the CDC has only one division involved with fluoridation and that is the Oral Health Division (OHD). OHD has virtually no medically trained personnel - most have only dental qualifications (see list of OHD personnel in 2008 ). Its function plain and simple is to PROMOTE fluoridation. No other division counter-balances their blatant conflict of interest or their lack of review of fluoride health studies. Thus, when the National Research Council published its landmark 507-page review Fluoride in Drinking Water: A Review of EPA's Standards on March 22, 2006, it took the CDC just 6 days to fall in line with the ADA's self-serving, and nonsensical claim, that this review had no relevance to water fluoridation! Thus the CDC is to water fluoridation, what the FDA is to mercury amalgams: an adjunct to the ADA. The ADA in turn acts as the go-between for the various corporations which profit from both practices. The very least we want from the CDC is a separate division reporting annually on all the fluoride health studies. In other words, we need a constant update of the work started by the NRC and an update untainted by the conflict of interest of promoting fluoridation.
Example 3. The EPA Water Division continues to drag its feet on determining a new MCLG for fluoride.
The NRC (2006) panel found that neither the MCLG (maximum contaminant level goal) or the MCL (maximum contaminant level) fpr fluoride, which are both set at 4 ppm, are protective of health. They recommended that the EPA Water Division conduct a health risk assessment to determine a new MCLG. Dr. Robert Carton, a former risk assessment expert at the EPA, has argued that if they did this properly (i.e. followed the mandates of the Safe Drinking Water Act) and determined a level which was protective of everyone, including vulnerable subsets in the population, for known and reasonably anticipated health effects, the new MCLG would have to be set at ZERO (http://fluoridealert.org/scher/carton-2006.pdf). This would kill fluoridation overnight. It has now been THREE YEARS AND FIVE MONTHS and the EPA has still not come up with a new MCLG. Guess why it is taking them so long to do this?
Example 4. EPA Pesticide division wants to INCREASE the use of sulfuryl fluoride (and fluoride residues) on food.
Some of you, who have been receiving these bulletins for some time, will be familiar with the shocking way that the EPA Pesticide division (OPP = Office of Pesticide Programs) has thrown good science and scientific integrity to the wind in order to approve the use of sulfuryl fluoride (and the fluoride residues it leaves on food, called "tolerances") by Dow AgroSciences for use as a food fumigant (ProFume™) in warehouses and processing plants. FAN, with the help of the Environmental Working Group and Beyond Pesticides, has been intervening in this process since 2001.
We are going to spend a little time explaining this situation (as clearly as we can) because it represents such a BLATANT and demonstrable example of scientific dishionesty.
Each time FAN has intervened and shown that people (especially infants) in the US are already exceeding the EPA's reference dose for fluoride of 0.114 mg/kg bodyweight per day - and thus NO new source of fluoride exposure should be permitted - the EPA has come back by raising the reference dose for infants. The OPP has done this not just once but twice! The first time they raised it to 0.571 mg/kg/day - five times higher than the adult reference dose of 0.114 mg/kg/day. The second time they raised it to 1.14 mg/kg/day. Which is TEN TIMES the adult reference dose (0.114 mg/kg/day). Below I explain their atrocious reasoning for the latest manipulation.
There is no other example in EPA's regulation of pesticides or pesticide residues, where a reference dose has been set HIGHER for an infant than an adult. Not only is it blatantly absurd from a toxicological point of view (infants are considered to be more sensitive than adults to toxics, not less so, especially for sensitive tissues like the brain and the endocrine system), but it is also a clear violation of the Food Quality and Protection Act (FQPA). The FQPA requires the EPA, when determining safe levels of pesticide residues, to apply a MORE stringent safety margin for infants and children because of their well known extra sensitivity to toxic substances during early development. The FQPA requires a default value of an extra safety factor of 10 (only less than10 if there is sufficient data indicating little or no impacts on children's development). So if we combine the outrageous manipulation giving a reference dose for children ten times higher than for adults, with this FQPA requirement for an extra safety factor of 10, the combined lack of protection for children jumps to a factor as high as 100!
Another aspect of the the OPP's unscientific behavior in this matter is that all three health risk assessments the OPP performed for the fluoride residues left by this fumigant, were predicated on the the 1986 EPA safe drinking water standard for fluoride of 4 ppm. When the NRC has concluded that the 4 ppm standard was NOT protective of health in 2006, FAN immediately sought a halt of the use of sulfuryl fluoride since ALL three of OPP's health risk assessments were no longer valid. Like our previous interventions, this has also been ignored by the EPA.
NOW, before the EPA pesticide division (OPP) has responded to FAN's arguments (and it has now been over SEVEN YEARS since we first submitted formal Objections) the EPA is considering a request from Dow AgroSciences to EXPAND its use of sulfuryl fluoride still further. The company now wants to use sulfuryl fluoride in fumigating soil before crops are harvested. Needless to say this would increase still further the exposure of the American people (and the people in other countries in which Dow gets permission to use this highly dangerous pesticide) - especially infants - to more fluoride, at a time when it is abundantly clear that our kids are already being OVER-exposed to fluoride (e.g. Dental fluorosis now impacts 32% of American children, CDC, 2005).
So once again FAN has had to submit comments on this issue, while still waiting for a response to our Objections - on the same matter - from over FIVE years ago (the first Objections, submitted in 2002, were deemed "moot" because Dow withdrew its request). See FAN's submission of August 24, 2009.
Please write to your Congressperson and Senators asking them to investigate why it is that Washington appears to tolerate flagrant abuse of science and scientific integrity among the agencies we expect to be protecting our health. Please choose any of the examples we have cited above.
As angry as you may feel about this, please be polite. The science is on our side with these issues and the other side can only win if we come over as distraught crazies, yelling and screaming about conspiracy theories.
What we want is is very simple and basic. We want the scientists who work for these agencies to do the job that they are paid to do: to protect the public. They cannot protect the public with phoney science. If they want to manipulate science in the corporate interest then let them go and work for these corporations.
Please send us a copy of any letter you send to your US Representatives and any replies you receive. It might make your task simply to enclose a copy of this bulletin and then add one or two sentences expressing your shock and dismay at this situation. Please note: your first letter won't do the job. You will get the standard blow-off letter. It is your second letter which really counts where you pull their lame response apart, or ask for genuine and concrete follow-up.
Meanwhile, please add your name (if you haven't done so already) to the over 21,600 people who have signed an ONLINE message calling for Congressional hearings to investigate the role (or lack of it) of the three agencies (FDA, EPA and CDC) who should have some responsibility in protecting the public from the side effects of swallowing fluoride - but don't exercise that responsibility (either moral or legal). You can sign on here.
Thank you for all you do in these matters.
Examination of the OPP's fiction on the reference dose for the fluoride ion for infants.
In its third health risk assessment (for sulfuryl fluoride tolerance levels for free fluoride ion) the EPA Pesticide Division (OPP) used the following reasoning. As with the previous two risk assessments, the OPP started with the derivation of the MCLG of 4 ppm. This has several key steps:
Step 1. The assumption that the only health end point of concern was crippling skeletal fluorosis.
Step 2. The assumption that the LOAEL at which this occurs is 20 mg per day
Step 3. The assumption that a safety factor of 2.5 would be protective for all adults from this end point.
Thus 20 mg/day divided by 2.5 gives a safe daily dose for adults of 8 mg/day.
At this point the normal and traditional way of determining what a safe dose would be for any other age range (and thereby range of bodyweight) is to divide this safe daily dose for adults by an adult's body weight (70 kg) to derive a safe REFERENCE DOSE of 0.114 mg/kg/day. This reference dose can then be used to back-calculate the safe daily dose for any other age range, by multiplying by the average weight for the age range in question.
For an infant the weight is taken as 7 kg, thus a safe dose would compute for them: 0.114 mg/kg/day x 7kg = 0.8 mg/day.
That's the normal regulatory and toxicological way of doing this - i.e. taking into account the difference in bodyweight for each age range.
In the OPP's third assessment, the OPP abandoned this traditional way -and toxicologically defendable way- and instead said that if 8 mg/day was safe for adults then it was safe for everyone regardless of age or bodyweight!
This is clearly a preposterous suggestion and makes as much sense as saying that, if 2000 mg of aspirin is safe for an adult, it would also be safe for 7 kg infant! By assuming that 8 mg per day was safe for everyone regardless of age or bodyweight, it allowed the OPP to produce an outrageously high reference dose for a 7 kg infant of 1.14 mg/kg/day: 8 mg/day divided by 7k bodyweight = 1.14 mg/kg bodyweight/day.
There is no rational scientific defense for such a manipulation. The only conclusion is that OPP was working backwards from what was needed to produce a risk assessment that would allow them to approve Dow AgroSciences agenda for using sulfuryl fluoride as an alternative to methyl bromide. In other words, OPP is violating scientific integrity and betraying the public's trust.
The OPP has failed to address the FAN, EWG and BP's challenge on these manipulations in their latest attempt to expand the use of Dow AgroScience's use of sulfuryl fluoride and simply continued as if we had not intervened at all. This clearly demonstrates a lack of good faith on their part.
Why on earth should the OPP go through the exercise of asking for public comment, not just once - but now FOUR TIMES - if they are merely going to ignore well-argued and well-documented interventions by those members of the public like ourselves who take the trouble to respond. Such behavior, in our view, simply underlines the OPP's desire to follow Dow AgroSciences agenda at all costs. The costs being in this case: the public's health, the public's trust, scientific integrity and the mandates of the Food Quality and Protection Act.
OPP's Use of the Food and Nutrition Board's UL
There is one other tame argument that the OPP has used to buttress its use of a 8 mg/day as being safe for everyone and that is their claim that the Food and Nutrition Board of the Institute of Medicine (IOM) 1997 report, Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride used an upper tolerance level (UL) value of 10 mg per day for a wide age range.* However, this hurts their case rather than helping it.
The IOM did indeed come up with a UL of 10 mg/day but did so only for adults and children of 8 years and above. The value they used for children younger than eight years, especially for infants, was much lower than this.
UL for Infants, 0 through 6 months - 0.7 mg/day
UL for Infants, 7 through 12 months - 0.9 mg/day
UL for Children, 1 through 3 years - 1.3 mg/day
UL for Children, 4 through 8 years - 2.2 mg/day
UL for Children and Adults > 8 years - 10 mg/day
If we consider just the UL for infants 0 through 6 months, and take the average bodyweight for this age range of 7 kg, this translates to a reference dose of 0.1 mg/kg/day (0.7 mg /day divided by 7 kg bodyweight) This is ELEVEN TIMES lower than the 1.14 mg/kg/day used by the OPP's third and latest health risk assessment.
*The IOM applied a totally unjustifiable safety factor of 1 (in their language an uncertainty factor of 1) to the revised LOAEL for skeletal fluorosis of 10 mg/day