Demand for Extension on HHS Comment Deadline

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JAMES ROBERT DEAL ATTORNEY PLLC
PO Box 2276, Lynnwood, Washington  98036-2276
Telephone 425-771-1110, Fax 425-776-8081
James@JamesRobertDeal.com

 

HHS WEBSITE IS DOWN
HHS PHONE NUMBER IS DEAD
HSS MUST EXTEND FLUORIDATION COMMENT PERIOD

 

February 14, 2011

Kathleen Sebelius
U.S. Department of Health and Human Services
Centers for Disease Control and Prevention
CWF Comments, Division of Oral Health,
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
4770 Buford Highway, NE, MS F-10
Atlanta, GA 30341-3717

Delivered by email to: CWFcomments@cdc.gov

Also sent by fax to: 202-690-7203 (fax for the office of Kathleen Sebelius)

For convenience in following links, this letter is available online at https://www.fluoride-class-action.com/hhs/demand-for-extension

The Word version is available at:

https://www.fluoride-class-action.com/wp-content/uploads/demand-for-extension.doc

Dear Ms. Sebelius,

I have prepared several pages of comments in response to your proposal to recommend fluoridation at the .7 ppm level. I was looking forward to submitting them to you. The comment deadline is Monday, February 13.

I have read everything on the HHS press release page:

http://www.hhs.gov/news/press/2011pres/01/20110107a.html

I have read everything on page which displays the pre-publication preliminary version of the HHS recommendations:

http://www.hhs.gov/news/press/2011pres/01/pre_pub_frn_fluoride.html

I have read everything on the final version of the HHS recommendations:

http://frwebgate2.access.gpo.gov/cgi-bin/TEXTgate.cgi?WAISdocID=W0YUwI/0/1/0&WAISaction=retrieve.

To complete my comments, I need to reread this last document. However, I am unable to do so because the link to it is dead. It is dead as I write this on Monday morning, February 14, at 9:00 am D.C. time. It was also dead on Saturday and on Sunday.

[I have since learned that the correct link is this:

http://www.federalregister.gov/articles/2011/02/28/2011-4343/proposed-hhs-recommendation-for-fluoride-concentration-in-drinking-water-for-prevention-of-dental

and this:

http://www.gpo.gov/fdsys/pkg/FR-2011-02-28/pdf/2011-4343.pdf

and this:

https://www.fluoride-class-action.com/wp-content/uploads/FederalRegister-2011-01-13-2383.pdf

or this at page 2383:

http://www.gpo.gov/fdsys/pkg/FR-2011-01-13/pdf/FR-2011-01-13.pdf]

There are many of us who are attempting to finalize our comments on this important issue who are unable to do so because we cannot read the document to which we would respond.

There have already been thousands of comments submitted to HHS on this contentious issue, and there will be thousands more submitted today, the deadline for comment. However, many of those will have been unable to read what they are commenting on.

I have to wonder whether my email sent to CWFcomments@cdc.gov will get through when I press send. I called the main office of HHS and got your fax number, 202-690-7203, Ms. Sebelius, so I only hope that this letter reaches you.

The EPA has extended its own comment period on fluoridation out another 90 days. Because of the mix-up on the link, because there are so many people who are currently studying this issue, and because the initial 30-day comment period was far too short for such an important issue, HHS too should extend its comment period out at least as long as EPA has done.

Your system for receiving comments is flawed in other ways. There is an email address to which comments may be emailed, although there is no mechanism to confirm receipt of emails. I made a comment to the FTA last year on a legal issue, and the FTA posted all comments on its website. The advantages of this method are twofold: The sender knows his comment has been received, and the discussion is improved because all can get feedback about what others are saying.

There is a physical address to which comments can be mailed. However, there is no fax number to which comments can be faxed. Modern fax machines no longer print out reams of paper: Faxes go directly to memory as PDFs. Faxing is almost the same as emailing. There are some people who have fax machines but no computers, usually but not always older people, who may be most affected by fluoride.

There is a phone number one can call, 770-488-6054, but usually no one answers when I dial it. I have left voice messages with various people at that number, including Barbara F. Gooch, Associate Director for Science (Acting) and Linda Orgain, communications specialist. Neither returned my calls.

There is more: Not only is the web link to http://frwebgate2.access.gpo.gov/cgi-bin/TEXTgate.cgi?WAISdocID=W0YUwI/0/1/0&WAISaction=retrieve dead, the 770-488-6054 phone number also is also dead. It is dead as I write these words at 9:00 am on Monday morning, February 14, East Coast time. It was dead also all day Sunday. I do not know how long it has been dead, however, I do know that this is very unusual for a federal agency that is receiving comments on a new regulatory matter. Most voice mail systems operate 24/7. The only person I was able to reach was Kip Dujon, chief fluoridation engineer. Mr. Dujon disavowed any involvement in comment procedure. He hung up on me when I tried to explain to him that the main telephone line for the Oral Health Division was dead.

I wanted to call and ask if emails could have attachments and what maximum size attachments the HHS server was set to receive. I also wanted to ask if we could send lengthy comments by sending a link to a website or use an FTP service such as www.Box.net, e.g., https://www.box.net/shared/8uv98cmi61. Most email services allow attachments only up to around 20 megs, but any size document can be uploaded to Box and then downloaded to the recipient who clicks on the link.

All in all, HHS has handled this comment procedure in a completely incompetent manner. A substantial extension to the comment period should be granted. If it is not, HHS will lose all credibility and might even be exposed to liability.

SUBSTANTIVE ISSUES

I will now add a few comments on substantive issues:

Water fluoridation does not reduce cavities. Water fluoridation causes severe short term side effects for around one percent of the population, the so-called fluoride hyper-sensitives. It also has cumulative long term side effects for all of us. Others have covered these health and scientific issues thoroughly, so I will not plow the same ground. Instead I will focus on legal and political issues.

HHS is proposing to recommend the addition of fluoride to drinking water at a level that the Safe Drinking Water Act (SDWA) prohibits any federal agency from requiring.

I will say that another way: The SDWA prohibits the federal government – and other governments, as I will point out below – from requiring that any fluoride be added to drinking water. Nevertheless, HHS proposes to recommend adding fluoride to drinking water at .7 ppm.

I have looked hard but I have failed to find any federal statute or regulation which authorizes HHS or CDC to recommend the addition of fluoride or any other chemical to drinking water for medical reasons. I believe there is none, and that HHS and CDC are acting outside the scope of their charge.

The SDWA specifically prohibits requiring the addition of any chemical to drinking water for medical purposes. See 42 USC 300g-1(b)(11)[3]:

No national primary drinking water regulation may require the addition of any substance for preventive health care purposes unrelated to contamination of drinking water.”

Clearly the federal government cannot require that municipalities add fluoride to drinking water. But what about the states? Can the states require that municipalities add fluoride to drinking water?

The federal government does not enforce or implement the SDWA and national primary drinking water regulations. It delegates that job to the 50 states. The EPA grants primacy to a designated agency in each state to implement the SDWA. 40 CFR 42.10. In Washington for example, the designated lead agency is the Department of Health. RCW 70.119A.080, RCW 43.21A.445. In RCW 43.21A.445 several Washington agencies led by the Department of Health are “… authorized to participate fully in and are empowered to administer …” the SDWA.

The states are the responsible parties who enforce and are subject to national regulations, so the states too, just like the federal government, may not legally require drinking water fluoridation.

It is thus illegal for states to make fluoridation mandatory, as California, for example, has done. California is violating the plain language of the SDWA.

Moreover, the SDWA is arguably binding on municipalities and arguably prohibits municipalities from requiring drinking water fluoridation. 40 CFR 142.3 provides:

… [T]his part [40 CFR Part 142—National Primary Drinking Water Regulations Implementation] applies to each public water system in each State.

Municipalities are the ultimate governmental bodies that require fluoridation.  HHS, the CDC, the EPA, and all other federal agencies deny vigorously that they require fluoridation. Most states claim they do not require it but only allow municipalities to require it. Municipalities in turn rely on the fact that the CDC and EPA recommend fluoridation.

The SDWA sets a 4 ppm maximum contaminant level, MCL, for fluoride. It comes as a big surprise to most people to learn that this 4 ppm limit is not an authorization to add fluoride up to 4 ppm, but a regulation requiring removal of any naturally occurring calcium fluoride in excess of 4 ppm.

The 2006 NRC Report at page 13 clarifies this, saying:

In 1986, EPA established an MCLG [maximum contaminant level goal] and MCL [maximum contaminant level] for fluoride at a concentration of 4 milligrams per liter (mg/L) and an SMCL [special contaminant level] of 2 mg/L. These guidelines are restrictions on the total amount of fluoride allowed in drinking water. … EPA’s drinking-water guidelines are not recommendations about adding fluoride to drinking water to protect the public from dental caries. …  Instead, EPA’s guidelines are maximum allowable concentrations in drinking water intended to prevent toxic or other adverse effects that could result from exposure to fluoride.

The EPA like the CDC has long had a love affair with drinking water fluoridation. Fluoride mixed with water at 1 ppm or .7 ppm meets federal definitions of the terms “drug” and “medication.” The Food, Drug, and Cosmetics Act (FDCA) defines a drug as an article

… intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal. 21 U.S.C. 321 (g)(1)(B)

Any addition of the fluoride-water drug mixture to drinking water should be an FDA matter because the FDA licenses drugs. However, the FDA has stated that it will never approve the addition of fluoride to drinking water. The closest it gets is allowing fluoride to be added to bottled water. It also allows bottled water to be made with city tap water that is artificially fluoridated. The big difference between fluoride in tap water and fluoride in bottled water is that people can choose not to drink bottled water but they cannot choose not to drink tap water.

The FDA was willing to cut a deal with the ever eager EPA and allow it to take jurisdiction over drinking water fluoridation. The FDA entered into an illegal memorandum agreement with the EPA in which the FDA quitclaimed all its jurisdiction over fluoridation to the EPA. The transfer was illegal because one agency cannot deed away its jurisdiction to another agency. Only Congress can do that.

The EPA gained jurisdiction over drinking water fluoridation by treaty, but it was still limited by the law as to what it could do with it. The SDWA forbade the EPA or any federal agency from requiring the addition of fluoride to drinking water. So in the 1980s the EPA transferred authority it did not have over fluoridation to a private trade group, NSF, the National Sanitation Foundation, and directed and financed its fluoride promotion program.

NSF proceeded to recommend the addition of fluoride to drinking water and to certify it safe to do so. Over 40 states allow fluoridation to proceed only if NSF approved fluoridation materials are used. Washington law allows fluoridation only if it is done using NSF 60 approved fluoride. See WAC 246-290-220.

Who or what is the NSF? A July 7, 2000, letter from Stan Hazan, then NSF general manager, to Rep. Ken Calvert:

NSF involvement in the evaluation of drinking water chemicals, including fluoride-based chemicals, began in 1985, when the U.S. EPA granted an NSF-led consortium of stakeholders the responsibility to develop consensus, health-based, quality specifications for drinking water treatment chemicals and drinking water system components. [emphasis added]

Municipalities rely on the NSF label. NSF puts its “NSF 60” stamp of approval on the fluoride tanker trucks that dump their loads every four days at fluoridation facilities up in the hills to the east of Seattle.

The EPA can only require that excess fluoride be removed from drinking water. It cannot require and should not authorize fluoride to be added to drinking water. The NSF cannot require fluoride to be added to drinking water, but it does authorize it to be added and does certify it to be safe to do so, thus enabling municipalities to require it.

NSF claims it does toxicological studies or receives such studies from fluoride suppliers. The February 2008 NSF Fact Sheet on Fluoridation Chemicals says:

The NSF Joint Committee … consists of … product manufacturing representatives. … Standard 60 … requires a toxicology review to determine that the product is safe at its maximum use level and to evaluate potential contaminations in the product. … A toxicology evaluation of test results is required to determine if any contaminant concentrations have the potential to cause adverse human health effects. … NSF also requires annual testing and toxicological evaluation …. The NSF standard requires … toxicological evaluation.

It is easy to prove something does exist but hard to prove it does not exist. Nevertheless, there is substantial evidence that NSF has no toxicological studies. First, there are no toxicological studies of fluoride on the extensive NSF web site at www.NSF.org. Blake Stark is the person at NSF International now in charge of fielding questions regarding Standard 60. Call Blake at 734-769-5480 or email him at Stark@NSF.org and ask him if there are any toxicological studies. He is an honest guy. He will tell you there are none. See an example of a Blake Stark response to a request for toxicological studies, labeled as Appendix D-67. See also a transcript of a California deposition in which another NSF official, Stan Hazen, admitted that suppliers are not required to deliver toxicological studies. See Appendix E from the Port Angeles case.

Most water districts do not even have a copy of NSF 60. The EPA finances and approves the publication of NSF 60, however, it is priced so high, at $325, that few buy it.

I have read NSF 60, and I can tell you that it is a convoluted web of contradictions, circular references, and exceptions that end up saying nothing. It mentions fluoride only in a few tables and does not specifically deal with the health issues or toxicological issues relating to fluoride per se.

Although the NSF 60 book is copyrighted, I believe the copyright to be invalid: The book is financed by the federal government, and government documents are not subject to copyright. Nevertheless, I have refrained from reproducing the entire book. Instead, I have excerpted 13 pages from this book of approximately 300 pages, certainly a reasonable number of pages to exhibit under the fair use doctrine, especially when the book is a fraud and it is important to make the fraud clear.

So I ask again, who or what is the NSF? NSF is a sham regulatory agency which has usurped the role of the FDA and the EPA so as to sidestep the SDWA.

The EPA has blessed and financed the NSF and has told the municipalities that they can rely on NSF fluoride certification. Municipalities are relying on recommendations from CDC, EPA, and NSF that fluoride it is safe and effective. The CDC and the EPA use NSF as a tool by which they effectively recommend authorize, and enable the municipalities to issue the final requirement.

Municipalities are urged on by a well- financed faction of dentists who have not done their scientific homework – and who support fluoridation unquestioningly. Pro-fluoride dentists probably still represent more than half of all dentists. The number of dentists who oppose fluoridation continues to grow. Pro-fluoride dentists are urged on by their dental schools, which in turn are urged on by giant chemical corporations which make big donations to the dental schools, and which have left over fluoride to sell, a byproduct of phosphate fertilizer manufacturing.

The EPA admits that there are two reasons why we fluoridate, first to prevent cavities but also as a way to offload toxic waste. It is illegal to dump waste fluoride into oceans or rivers but it is legal do so indirectly by going through public water systems first and then into oceans and rivers.

No federal agency has ever approved water fluoridation. The CDC, which is under the HHS, praises fluoridation, but it has no jurisdiction to approve or require it. Nevertheless, HHS and CDC are proposing to make a recommendation that fluoridation is effective and safe at the .7 ppm level.

HHS is making this proposal, but it is apparently the Dental Division of the CDC that is handling matters. The email address that this comment will go to is CWFcomments@cdc.gov, which is in the CDC. When I dial 770-488-6054 and leave a message, it is the CDC on the answering machine – when the answering machine works.

This proposal by HHS to reduce fluoride added to drinking water is a response to the 2006 National Science Council report on fluoridation. As such, it is an inadequate response. It ignores the effect of fluoride on bones, kidneys, pineal, thyroid, brain, and many other organs and bodily functions. It focuses only on teeth, as if the fluoride we drink magically goes only to the teeth. HHS included references to some 40 to 50 journal articles. Most of them pertained to teeth and fluorosis and said little about the effect of fluoride on other organs.

The HHS proposal completely ignores the latest research regarding serious increases in lead levels as a result of fluoridation. HHS’s proposal is bad science.

HHS and the Oral Health Division of the CDC should make no recommendation that communities fluoridate at .7 ppm or at any level. It should get out of the fluoride cheerleading business.

I would close by asking this question: According to what statute or regulation, does HHS or CDC have any authority to make any recommendations whatsoever regarding adding chemicals to drinking water for medicinal purposes? And by what authority does the CDC engage the services of a “chief fluoridation engineer”?

And finally, what would make you think that HHS or CDC, especially the Oral Health Division of the CDC, in light of its pro-industry bias and its revolving door relationship with the chemical industries it regulates, has the necessary level of independence or competence to deal fairly with the scientific issues involved?

Again, I would point out that for convenience in following links, this letter is available online at https://www.fluoride-class-action.com/hhs/demand-for-extension

The Word version is available at:

https://www.fluoride-class-action.com/wp-content/uploads/demand-for-extension.doc

Sincerely,

James Robert Deal, Attorney
WSBA Number 8103
President, Fluoride Class Action
http://Fluoride-Class-Action.com