For the previous months leading up to this event, Jill Jennings-McElheney of the Northeast Georgia Children’s Environmental Health Coalition worked to arrange a teleconference meeting with officials in U.S. regulatory agencies to dialogue with non-government participants on issues pertaining to the toxicology and science of fluoride (and if possible, the ethics of their decision-making). This teleconference was entered into by the non-regulatory participants in an effort to end the cycle of one-way communication with regulatory agencies on this issue and to open an on-going dialogue.
An event occurred during the lead-up to the teleconference that nearly derailed it. A New Jersey reporter, in covering the issue of an upcoming fluoridation vote by the Egg Harbor City Council, interviewed John Bucher, PhD, an Associate Director of the National Toxicology Program. The newspaper ran three articles that included Bucher’s comments on March 25 and March 26. Dr Bucher was a participant in the teleconference and received all emails leading up to it. His comments to the paper shocked the non-government participants. To read Bucher’s comments, click here.
The half-hour teleconference took place on April 9th at 2 pm EDT and lasted for 30 minutes. It was recorded.
Regulatory officials on the call:
• Linda Birnbaum, PhD, DABT, ATS. Director of the National Institute of Environmental Health Sciences (NIEHS) and the National Toxicology Program (NTP)
• John Bucher, PhD, Associate Director, NTP
• Phil Oshida, PhD, Deputy Director, Standards and Risk Management Division, Office of Ground Water and Drinking Water, US Environmental Protection Agency (EPA)
Private sector participants:
• Gerald Steel, Attorney at Law, Olympia WA
• Bill Osmunson DDS, MPH, and Board Member of the Fluoride Action Network.
• Bill Hirzy PhD, Fluoride Action Network and former risk assessor with the US EPA.
• Chris Neurath, Science director, American Environmental Health Studies Project, Inc.
• Jill Jennings-McElheney, Northeast Georgia Children’s Environmental Health Coalition.
Also on the call:
• Chris Nidel, Attorney at Law, Washington DC
In preparation for the conference, Gerald Steele and Bill Osmunson submitted separate memorandums to the regulatory participants that dealt mainly with unresolved and unanswered questions, such as ‘who’s in charge of the fluoridation program: FDA or EPA?’ etc. The overwhelming majority of these questions were not discussed during this call and we learned during the call that they will not be responded to.
Both Steele and Osmunson gave opening statements that overviewed their respective memorandums, and Steele moderated the conference.
The following transcript was done by the Fluoride Action Network
At 13:20 minutes into the conference call the first question put to regulatory participants was from Bill Hirzy to Phil Oshida
[BMD: Benchmark Dose Analysis
In brief, this estimates a safe dose or safe exposure limit in human health risk assessment. For more information click here]
Hirzy to Oshida: In September, I and some other folks from our organization, met with Peter Grevatt [Director, Office of Ground Water and Drinking Water] and Ken Kopocis [Deputy Assistant Administrator, Office of Ground Water and Drinking Water] at EPA, and we were left with the impression after that meeting that Peter was going to pass on the information that we shared to members of his staff. And I have a question for Phil Oshida: Has anybody at EPA to your knowledge done any Benchmark Dose analysis of the data that we shared with you guys in September and then again in March?
14:01 Oshida What we’re doing with the information that you provided to us – as you know we are in the midst of completing what we call a 6-year review. We have teams working on reviewing all of our current drinking water regulations to determine if we would recommend that they be updated and/or revised
14:36 Hirzy …could you just answer my question on whether anyone has done anything in terms of a Benchmarch dose analysis on the data that we supplied you in September and then again in March? Has anyone done anything on that?
14:47 Oshida I am not sure…
14:57 Oshida The information that you’ve provided to us has been provided to the people on our staff that are working on reviewing the available information in the evaluation of fluoride…
15:12 Hirzy to Oshida – could you get back to me by email or by telephone and let me know whether anyone has done a Benchmark dose analysis… In reading the guidance documents on Benchmark Dose analysis it’s recommended that that work be done in conjunction with someone who has a great familiarity with the process and we would like very much to be able to do that to rerun our Benchmark Dose analysis with someone from EPA or NIEHS who is extremely familiar with the Benchmark Dose process. Could you provide someone to work with us on that?
15:58 Oshida to Hirzy What we are doing right now is we are taking the information that you provided to us and we are reviewing it in the 6-year review process. The 6-year review process is scheduled to be completed at the end of this year or the beginning of next year.
Hirzy That is not the question I asked you. I asked if you would provide somebody to help us…
16:27 Steele to Oshida: … The question that I would like you to answer is, will you find out if there is a Benchmark dose analysis being done and if it is still going to be done would you find out if Chris Neurath can be in contact with the people that are doing it? Can you find that out for us and get back to us on that point?
16:59: Oshida: I’ll work on it.
17:10 Hirzy to Oshida: Does EPA still think that severe dental fluorosis is the more sensitive end point than diminution of IQ? Do you have any opinions on which is the more sensitive endpoint?
That is part of the analysis that is going on in the 6- year review. We are not going to cut that analysis short to answer specific questions. This is an analysis that is looking at all the available information.
There is no NTP policy related to the safety of fluoride or fluoridated drinking water.” NTP would be very interested in having you submit a formal nomination to us for a study. “We do animal studies. We do hazard evaluations. We do not do risk assessments. We use a systematic review approach which looks at all the available information and brings in multiple lines of evidence -animal evidence, mechanistic data, human evidence as well, and you certainly are encouraged to develop a nomination for us to that.
I have asked John to tell you a little bit more about what is going on, or how we are doing systematic review, and how we are helping the Australians who are looking at fluoride, helping to teach them how to do a systematic review as well.
19:54-22:35 John Bucher:
So I think I know that you already familiar with the fact that the Australian government is carrying out a re-review for several of their regulatory processes for fluoride. They are carrying out a Cochrane style systematic review of the health effects literature on fluoridation, specifically on fluoridated water. They have spent some time looking at the Chinese studies, the IQ studies, and they have asked us to help them because they are not familiar with the methodologies that are used to carry out systematic reviews of experimental animal literature. I don’t know how much you know about systematic reviews but this is a way of pulling together information, extracting information, from literature studies, literature reports and of what they call gray literature in some cases, that is not necessarily peer reviewed. Pulling that together, extracting the information in a format that people can then work with, to evaluate the quality of the studies that are reported, and evaluate the potential for what they call risk of bias, which is various forms of confounding or issues that might not have been fully taken into consideration in the analysis that’s presented. And once all that is done for each paper they then aggregate the information using the studies that are of the highest quality to reach public health decisions. We are working on developing methodologies in the experimental animal literature realm. We are working with them to carry out an evaluation of the neurotoxicology literature related to fluoride exposures and ideally animal. The whole purpose of this is to be able to share all of the information that’s used in reaching a decision. It is a highly transparent process so that one can understand exactly how the decisions are made and the critical pieces of information that are used to reach those decisions. We have been working with the Australians. They have been working in parallel with us to evaluate this information. It is theirs to use to see fit in reaching their public health goals for drinking water for Australia.”
Steele to Bucher: who is the contact in NIEHS in Australia for this process?
Bucher: Ask me [unclear] and I will be the go-between.
Chris Neurath to Bucher:
You said it’s highly transparent. Transparent in the sense that they would invite participation during the process by interested parties such as us? Or is it basically a black box to the public until it’s all done?
Actually it’s a transparent process typically with respect to – usually the literature searches, the strategies are made available, the actual literature, what literature is found is made available. There are usually public calls for information if there is missing information that people know about that hasn’t been evaluated. It is an interactive process where the public can be involved in several steps.
Could you give me an Australian contact as well? We do have people that we do work in Australia.
24:10 Steel to Bucher. Can you give me your Australian contact.
Bucher: … I don’t have those names right not…
24:55 Birnbaum: Could you also be responsive and let us know who the person was that you dealt with [in Australia}?
25:00 Steele: … I will find out.
25:21 Chris Neurath.
I got a question on research funded by NIEHS in regards to fluoride. I know there are at least 2 projects looking at developmental neurotoxicity. One led by Howard Hu and the other by Pam Den Beston. Den Beston is in animals and Hu’s is in humans in Mexico, mother-child pairs. Both of these are fairly recently funded studies with millions of dollars behind them. Is Dr Birnbaum familiar with these studies
26:32 Neurath As far as I know there is no published results from either of them. Which gets to my other question. Is there an obligation from grantees, people who have been given NIEHS funds, to publish results including what their proposal said they would study.
So grants are what we call an assistance agreement. We have basically no control over what the grantee does with the funds once they receive it. However, they don’t get all the money up front. It’s given on a yearly basis. The grantees are responsible for annual progress reports to let us know what they are finding. The grantees know that if they want to be refunded 4 or 5 years later, depending on the time of the original grant, that if they don’t publish anything, they are not going to get funding the next time around…
One other related question. NIEHS sponsored Dr Chester Douglass’ osteosarcoma study*, which I’m sure Dr Bucher is familiar with, that was about 20 years ago. Is there any obligation to eventually share data from studies like that with other researchers? I know there is currently a NIEHS policy for more recent grants set up to share their data…. Are there any guidelines?
29:16 Bucher: …I don’t know what the rules were at the time…
30:02 Birnbaum: … We can try to find out for you what the policy was when this grant was funded 20 plus years ago…
End at 31:23.