WASHINGTON ACTION FOR SAFE WATER

Bill Osmunson DDS, MPH

President, Washington Action for Safe Water

1418 – 112^th Ave NE

Bellevue Washington 98004

425.466.0100

bill@teachingsmiles.com

June 14, 2010

National Freedom of Information Officer
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW (2822T)
Washington, DC 20460
(202) 566-1667      FAX (202) 566-2147
E-mail: hq.foia@epa.gov

Re: Freedom of Information Act Request

Dear Sir or Madam:

This is a request under the Freedom of Information Act for the following information to be provided to me:

#1.       A digital copy of the EPA’s equivalent of the FDA’s New Drug Approval process for the fluoridation drug when used at 0.8 ppm to 1.2 ppm in public water, to include EPA’s required documentation for chemistry, nonclinical pharmacology and toxicology, human pharmacokinetics and bioavailability, clinical microbiology, clinicals, safety, statistics, case report tabulations, patient information on any patient claims, patient certification, establishment descriptions, and required drug legend.

#2.       A digital copy of records, reports, papers, meeting minutes, correspondence or clarifications of the MOU 225079-2001 http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116216.htm between the EPA and FDA.  And any records further clarifying the intent of the MOU 225079-2001 or another MOU as to whether the EPA is permitted to approve the sale and use of substances defined as drugs by the FD&C Act, when the substance is added to public water. 

#3.       Records the EPA has of Congressional Authority which exempts drugs when added to public water from the New Drug Application regulatory process and FD&C Act and provides the EPA with authority to approve drugs when they are added to public water. 

            In order to help to determine my status for purposes of determining the applicability of any fees, you should know that I am the President of Washington Action for Safe Water a 501 (c) 3 Corporation, and I request a waiver of all fees for this request. 

Disclosure of the requested information to me is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government and is not in our commercial interest.  The information will be used in creating new regulations for water safety in Washington State. 

If fees cannot be waved, please provide a list of documents and the costs associated with each.

I request that the information I seek be provided in electronic format, and I would like to receive it on a personal computer disk or a CD-ROM or email to bill@teachingsmiles.com or US postal service to the address below.

Thank you for your consideration of this request.

Sincerely,

Bill Osmunson DDS, MPH

President, Washington Action for Safe Water

1418 – 112^th Ave NE

Bellevue Washington 98004

425.466.0100

bill@teachingsmiles.com

cc Ned Therien, WBOH  ned.therien@doh.wa.gov