Here is a sample of what you unfortunately have been involved in and why I am confident of my predictions. EU has already begun blackballing Nano Material in Masks and here is what the Policy office for the , International Center for Technology Assessment & Center for Food Safety has written to the FDA and the EPA alll based on the HC Reaction. So now it behooves HC to do significant Research to justify their warning. Otherwise its a Cry Wolf routine and HC loses face. So this will take a lot of time to sort out. IMHO
Final Letter to FDA/EPA iatp.org
Content
Janet Woodcock, M.D. Acting Commissioner Food and Drug Administration 10903 New Hampshire Avenue, Silver Spring, MD 20993 FDAOMA@fda.hhs.gov
Michael S. Regan Administrator Environmental Protection Agency 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460
Dr. Treye A. Thomas Program Manager Chemicals, Nanotechnology and Emerging Materials Office of Hazard Identification and Reduction U.S. Consumer Product Safety Commission 5 Research Place Rockville, MD 20850 April 20, 2021
Dear Dr. Woodcock, Mr. Regan and Dr. Thomas,
Re: Engineered nanomaterials in masks claimed as protection against COVID-19 We write to urge you to use your authorities and competencies to ban the import and sale of medical masks and civilian equivalents in the United States and its territories that incorporate certain nanoscale materials.
Furthermore, you should recall any such masks presently in the United States and its territories and strongly advise against the continued use of such masks because wholesale and retail recalls will not prevent the use of these masks by individuals unaware that regular use of the masks, e.g., by teachers and school children, will result in inhaling these nanomaterials at occupational exposure levels.
Jim Thomas, of the ETC Group in Canada, has aggregated Department of Commerce Harmonized System data on U.S. imports of Shengquan Group masks. Shengquan is a prominent global manufacturer of medical and civilian use masks incorporating biomass derived nanographene. Mr. Thomas estimates that companies including Shengquan USA, SQ Medical, Shengquan Canada, Aussino, Dolbec International, BP Exploration and others have imported into the U.S. over 600 million masks from Shengquan New Materials company since the beginning of the pandemic.
1 We attach an Excel spreadsheet with Mr. Thomas’s Harmonized System data and his aggregation calculations. (Attachment 1) Shengquan masks incorporating nanographene “heal fiber” are not always advertised as such, so it is impossible to determine what percentage of the masks incorporate nanographene.
The certificate of registration by one importer of the Shengquan masks explicitly notes that the certificate does not constitute Food and Drug Administration approval of the mask.
2 However, Shengquan states in its marketing materials that its nanographene masks provides “equivalent protection” to that of National Institute for Occupational Safety and Health (NIOSH) certified masks and implies its imported masks are FDA approved. We make this request in the full recognition that mask wearing continues to be a public health measure of critical importance as we enter the fourth wave of COVID-19.
However, recent events concerning masks that incorporate antimicrobial nanomaterials provide evidence of the urgent need for you to take precautionary actions for imported masks that have not undergone pre-market safety reviews and post-market surveillance. On April 2, Health Canada issued an advisory, “Face masks that contained graphene may pose health risks” due to the inhalation of nano-scale graphene particles.
3 Canadian TV disclosed that the masks entered Canada through a misstep on the supply chain, along with an emergency order to facilitate COVID-19-related supplies, so the masks were subject to very little oversight. The FDA spokesperson Audra Harrison contradicted the company claim that its masks had “passed the United States FDA certification.”
..........................................................................................The authors conclude that “based on the scarce available evidence, it cannot be excluded that some forms of graphene will be as potent a toxicant as carbon nanotubes”.18 We strongly support the wearing of masks to protect against COVID-19, but the masks must all use properly registered ingredients and not be toxic to the masks’ users. We urge you to withdraw these potentially toxic nanographene, nano silver and nano copper masks from the U.S. market.
Sincerely, Jaydee Hanson, Policy Director, International Center for Technology Assessment & Center for Food Safety |