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USA: Hevige polemiek gaande n.a.v. de nieuwe groen-licht-strategie van de FDA De hoogste autoriteit op het gebied van de bescherming der burgers tegen schadelijke milieu-invloeden, de FDA (Food and Drugs Administration) heeft op haar website (Cell Phone Facts: Consumer Information on Wireless Phones) alle voorzorg met betrekking tot mobiele telefonie laten varen en alle vroegere verwijzingen naar studies met negatieve effecten op de gezondheid weggehaald. Daarvoor in de plaats heeft zij een radicale groen-licht-strategie ingevoerd door te stellen dat er geen enkel voorbehoud gemaakt hoeft te worden bij het gebruik van draadloze technologie www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/CellPhones/ucm116282.htm . zelfs niet voor kinderen. www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/CellPhones/ucm116331.htm . Terwijl gezondheidsautoriteiten in andere landen zoals Frankrijk en België (maar niet in Nederland) juist waarschuwingsgeluiden laten horen begeeft de FDA zich duidelijk (in navolging van de Commissie EMV van de Nederlandse Gezondheidsraad?) op een frontale ramkoers met critici van de draadloze maatschappij. De reacties in de USA zijn vehement. Onderstaand met dank aan EMFacts Consultancy het weerwoord van Cindy Sage, uitgeefster van het Bio-Initiative Report in twee bijdragen: 1. From Cindy Sage: The FDA’s most recent dismissal of brain tumor risk from cell phone use is stunning in its timing. While other countries of the world are now advising consumers to take precautionary action, the FDA is issuing an “all clear”. Based on new evidence of risk from cell and cordless phone use, we should expect the FDA to step up and give us confidence they can handle this job of regulating pharmaceuticals and other potentially toxic exposures. Instead, they are reaching for another Vioxx moment. This is reminiscent of the National Academy of Sciences issuing an “all clear” press release at the conclusion of the study on electromagnetic fields in 1996, when the study itself pointed to public health risks. Contributing authors complained, but the damage was done. Get to the press early and confuse the message, and the public will be flim-flammed with contradictory messages. In April of this year, I briefed the FDAs Center for Devices and Radiological Health in Rockville, MD. At their invitation, David Carpenter and I spent an hour discussing the BioInitiative Report findings and recommendations. I offered the advice below based on the in-depth review of relevant published scientific literature and prudent public health response to it. Exactly the opposite happened. About two weeks after our meeting, the FDAs website content changed, but not in the direction warranted by the growing evidence of harm. FDA’s pronouncement that cell phones pose no risk to users appears to be a pre-emptive strike. Not only does it negate the findings of several recent scientific studies and reviews reporting brain tumor risks at 10 or more years of use, but will also counter the imminent release of the final Interphone Report. Several members of the Interphone study teams have openly discussed that the evidence is showing cell phone users with 10 or more years of exposure have higher rates of glioma, a malignant brain tumor. • Who told the FDAs Communications branch to issue an “all clear” on cell phone risks? • On what new evidence of safety of cell phones did the FDA Center for Devices and Radiological Health change its mind and decide it was time to tell the public that there is no risk? That the Interphone research would find risk of brain tumors must not have been anticipated by FDA. Previously they used the on-going Interphone program work as a benchmark to stall reasonable precautionary responses to growing public concern and to urge us “to wait for the evidence”. Now that the evidence is pointing to big trouble, they’ve taken all references to the Interphone study off their website. Issuing a positive assertion of safety and denying evidence to the contrary puts the FDA squarely in opposition to other countries whose health agencies are urging parents to reduce cell phone use for themselves and for their children. It puts the FDA at odds with some of the research team members of Interphone that have already broken ranks and given warnings that brain tumor risks are demonstrated. The international response to FDAs dismissal of cell phone risks has been immediate and negative. Undermining the message of the final Interphone Report and other scientific studies and reviews that do show risks at 10 years and longer cell phone use is widely seen as a tactic to sow doubt, discredit the research, and undermine cooperative action among governments to develop new policies and regulations. The FDA is reaching for another Vioxx moment with this bizarre move. With its credibility at an all-time low, the FDA should know from experience it cannot bury evidence of health risks for long. 2. Comment to the FDA Center for Devices and Radiological Health on the issue of cell phones, cordless phones and PDAs. Cindy Sage Co-Editor, BioInitiative Report What the FDA Should Do About Communicating Radiofrequency and Microwave Radiation Wireless and Cell Phone Risks to the Obama Administration FDA should advise the Obama economic team that ignoring health risks likely to arise from long-term cell phone and cordless phone use will have high economic costs for health care. FDA should advise the Obama economic stimulus package team that a large financial commitment to wireless broadband is premature, and may result in higher health care costs and costly retrofitting later. Stick with wired broadband solutions. FDA should assess the potential costs and health risks likely to be associated with broadband over powerline (BPL) , SmartGrid wireless technologies, and mandated use of compact fluorescent bulbs for energy conservation. All pose potential health risks from chronic exposure to low-intensity RF/MW. What the FDA Should Do About Communicating Wireless Risks to the FCC FDA should take formal note of the BioInitiative Report and other recent studies that establish the existence of low-intensity ELF- and RF effects and so advise the FCC. FDA should formally recognize the three fundamental conclusions of the BioInitiative Report. 1) Low-intensity effects are conclusively established (effects that occur at exposure levels far below existing safety standards); 2) Existing FCC and ICNIRP standards are obsolete; and 3) New, biologically-relevant public safety limits are needed with respect to new wireless technologies and for extremely-low frequency power fields (60-Hz power frequency fields) from power lines, appliances and electrical wiring. FDA should advise the FCC on the need for new, biologically-relevant public exposure standards for cell and cordless phones, and other wireless devices (PDAs). What the FDA Should Do About Communicating Cell Phone Risks to the Public FDA cannot make a positive assertion of safety on long-term cell and cordless phone use and should amend its advice to agencies and to the public accordingly. FDA should amend its website with updated cautions to the public about long-term brain tumor and acoustic neuroma risks. FDA should issue a warning advising against the routine use of cell phones by children. FDA should promote wired alternatives to wireless internet for schools – take a ‘wait and see’ position on new wireless technologies. FDA should establish a policy that selects for a public-health based standard of evidence for judging the science. It should reject the demonstration for scientific certainty of harm from cell phone use and other wireless exposures as a basis for taking preventative action and issuing interim warnings. The FDA should act proportionately to the risks so far reported; and consider disproportionate risks that may accrue to children. Why? FDA will be hard-pressed to explain why no cautionary warnings were issued for health impacts that could have been greatly reduced or avoided entirely. FDA should get ahead of this curve and avoid unnecessary costs to the healthcare system, unnecessary deaths and medical costs, and unnecessary investment in wireless technologies that will have to be replaced at high cost later. FDA is vulnerable to charges of “too little-too late”, of being overly deferential to industry at the expense of the public’s health and children’s safety. It will be far less costly to implement safer, wired technologies today than to replace them later, once costs to the health care system become apparent. Early action to choose non-wireless (wired) alternatives can prevent much of this economic shock wave. The public health costs given the millions of users, and more millions affected by second-hand radiation will be enormous. FDA stands to suffer loss of reputation and credibility if it fails to enact/recommend preventive actions that are proportionate to the current knowledge about NIER. The cost of inaction is too high given the existing body of international scientific and public health evidence we have available today. Potential public health consequences may reasonably include chronic inflammatory diseases, cancer, neurological diseases, addiction and sleep disorders (with corresponding loss of cognitive function, judgment, behavioral problems, loss of healing ability, loss of cancer surveillance, interference with metabolism. Other governmental agencies around the world have already issued various cautions and precautionary advice to the public on wireless exposures. The governments of Belgium, France, Germany, Finland, Lichtenstein, Austria, Switzerland, Greece and Sweden have already taken public positions encouraging precautionary action. Medical associations in many countries have issued resolutions that warn the public of risks from cell phone use and other wireless technologies like WI-FI and wireless internet. The FDA will have to explain to Congress and the public why it continues to adhere to outdated policies and ignores mounting evidence of health risks. FDAs activities will be seen as cosmetic and enabling to the industry at the expense of public health and well-being, if it ignores the global shift to precaution on EMF. The FDA cannot afford to ignore the potential health effects of chronic, indiscriminate exposures to ELF and RF – it has the potential to be another “Vioxx” moment for FDA. Public trust is already stretched thin over FDA failures to protect the public. FDA cannot rely on “the NAS research program” or the NTP toxicity evaluation of RF to justify inaction. These programs are an insufficient response, are not proportionate to the risks involved, and provide no cover to FDA for positive assertions of safety that are no longer credible. FDA will have to respond to WHO Interphone results on malignant brain tumors, acoustic neuroma and parotid gland (salivary gland) tumors. Individual country studies report more than a doubling of risk for gliomas at 10 or more years of use, ipsilateral use for adults; and more than a five-fold risk for children who use cell phones in their pre-teen and teen years as measured when they reach the 20-29 year age group. Measures to reduce cell and cordless phone exposures are available, and would very likely reduce risk of brain tumors. The FDA should take action to highlight these “early warnings” and recommend precautionary and preventative action. The FDA should discuss strategies for emissions reduction with cell phone manufacturers. It has been the same for most environmental carcinogens – that change comes when political will dictates change: not when the science conclusively proves an effect. An FDA failure to act in a timely and proportionate way will be judged to be complicit concealment on behalf of industry interests. Voor het origineel zie: www.emfacts.com/weblog/?p=1120 .
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