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A Petition for Imminent Hazard Rulemaking to the U.S. Department of Health and Human Services (HSS) has been filed by Americans for Responsible Technology, Environmental Health Trust, Consumers for Safe Cell Phones and numerous additional petitioners to correct false and misleading claims regarding the Food and Drug Administration official policy determinations of safety standards for Radio Frequency Radiation (RFR) emitting devices and systems.

Government officials, and the public have repeatedly been told the FDA ensures safety when it comes to cell phones and wireless radiation, but the historic court judgement in Environmental Health Trust et al v the FCC clearly highlighted the fact the FDA has not conducted a formal, thorough review of the safety of cell phones, wireless devices or wireless infrastructure. However, the FDA continues to assert unsubstantiated statements  on its website and in official letters as documented by EHT in our declaration. In turn, this information is transformed into inaccurate statements by the media and wireless companies to promote the illusion that wireless is safe. As a result, 5G and wireless networks are rapidly being deployed in neighborhoods, schools and workplaces across the USA. 

Read the petition  with numerous declarations here. 

Read the full Declaration of Environmental Health Trust. 


Summary of EHT’s Declaration

We believe the FDA has made numerous misleading misrepresentations and critical omissions regarding the FDA’s level of review and risk assessment for the public health risks of 5G, cell phone and wireless radiofrequency radiation (RFR). The American public, elected officials and agencies at the local, state, local and federal level have detrimentally relied on the FDA, erroneously believing that the agency has evaluated the totality of the science, and that the FDA has officially determined that there is no public health risk from exposure. 

 

The FDA’s numerous misrepresentations and critical omissions regarding it’s activities and level of review of the science convey the false illusion that safety is assured

As detailed in this Declaration, the FDA has not systematically reviewed the “totality” of the evidence to determine public health risks, nor has it evaluated the FCC limits with a science based methodology. The agency has repeatedly refused to answer questions related to its activities regarding wireless radiation, and refuses to correct inaccurate information on its website. 

The FDA has omitted that the Agency has no authority in regards to cell tower emissions and has not scientifically evaluated cell tower antenna maximum permissible RFR levels, nor 5G modulations and has not publicly shown any systematic evaluation of published studies on brain development and reproduction. The FDA omits that it has no authority or expertise regarding impacts to non humans- wildlife trees and plants. The FDA is aware that cell phone radiation exposures can be so high that they may exceed the FCC’s limits when phones are resting on the body or carried in a pants pocket or bra, but omits this information from its public communications.The FDA is also aware that a child’s developing brain and a fetus are more sensitive to cell phone radiation, but has chosen to omit information on children and fetus vulnerability, dangerously downplaying the human health risks to the American public. 

The FDA’s misleading information has influenced the public, media, medical professionals, courts and government officials at local, state and federal levels which has led to the unchecked rapid proliferation of wireless networks across the nation in schools, neighborhood streets and workplaces. 

At the core of the problem is the fact that the FCC’s human exposure regulations for wireless RFR/EMF radiation have remained unchanged since 1996, and this is directly due to years of FDA’s haphazard activities and silence regarding the health effects of cell phone radiation. As the EPA was defunded from research on RFR/EMF in 1996, the FDA has long been the only federal health agency considered to have authority to opine on RFR/EMF health issues, due to the FDA’s power to regulate radiation emitting electronic products under the provisions of the Food, Drug and Cosmetic Act. 

In 2013, the FCC opened up an inquiry seeking comment on the adequacy of these 1996 human exposure limits, and the FDA did not respond for years. Then, on April 24, 2019, FDA Director of the Center for Devices and Radiological Health Dr. Jeffrey Shuren submitted a letter to the FCC with one paragraph dedicated to the issue which stated, “the available scientific evidence to date does not support adverse health effects in humans due to exposures at or under the current limits…Soon after on December 4, 2019 the FCC made a decision not to update its 1996 RFR/EMF limits largely based on this FDA letter, and the FDA’s web pages and FDA Shuren’s statements rejecting the conclusions of the National Toxicology Program study that found cancer and DNA damage in rodents. 

Environmental Health Trust and 13 petitioners filed a lawsuit against the FCC for this 2019 refusal to update the federal regulations, and we argued that the FDA had not shown any substantive science based report nor risk analysis to substantiate their online statements and April 2019 Submission to the FCC. 

 

On August 13, 2021, the United States Court of Appeals for the District of Columbia Circuit made a judgment in our case and ruled that the FCC had failed to show that its re-affirmation of those 25-year-old wireless radiation limits was based on a reasoned evaluation of the relevant scientific evidence because it ignored record evidence about children’s vulnerability, non-cancer effects, impacts to wildlife and the environment, and the effects of long-term exposures. Importantly, the Court found that the FCC had improperly relied on FDA’s “conclusory statements” regarding RFR and health – the very same statements we document in this Declaration as misrepresentations. The court stated the FDA’s statements “represent a failure by the FDA to address the implication of Petitioners’ studies: The factual premise—the non-existence of non-thermal biological effects—underlying the current RF guidelines may no longer be accurate.”

The FDA’s subsequent 2020 release of “Review of Published Literature between 2008 and 2018” further proved that the FDA’s conclusion of no harm is unsubstantiated by FDA review, because the FDA’s literature review was limited to cancer and cell phones only. It did not include a review of the literature on non-cancer health effects (brain damage, oxidative stress, reproductive harm, etc.), and did not include a review of cell tower studies or environmental effects. Importantly, the FDA’s 2020 literature review was not a risk assessment nor hazard identification report and it had numerous inaccuracies – inaccuracies which remain uncorrected to this day. Yet the FDA misleadingly presents this review as proof of safety. 

The FDA’s failure to honestly present its EMF activities, and its misrepresentations regarding the adequacy of the FCC’s human exposure limits, have led to a rapidly increasing nationwide RFR/EMF exposure for all age groups, putting the entire U.S. population at risk. The FCC’s limits and the FDA’s misrepresentations are used as proof of safety for the rapid deployment of 4G and 5G wireless networks nationwide. Because of this failure, government officials at all levels have rejected evidence presented to them by constituents indicating that densified wireless infrastructure is unsafe, and instead officials are funding new wireless projects in schools and communities. Half the states in the country have passed small cell legislation which strip local authority and fast-track cell tower installations into neighborhoods, many allowing cell antennas less than 50 feet from homes and bedrooms, significantly increasing the environmental RFR/EMF exposures and leading to documented harms. 

People have been injured, and will continue to be injured, by wireless networks and wireless devices brought to market under the FCC’s 25-year-old, outdated regulations — rules that the FDA has rubber stamped by its inaction, omissions and misrepresentations. 

The FDA omits critical information about its scope of authority and level of review to policymakers, allowing false safety assumptions to be widely disseminated. For example, when asked about the safety of 5G networks, the FDA omits to members of Congress that it has no authority regarding cell tower antenna radiation, and the FDA also omits that no US environmental agency is actively monitoring the escalating environmental RFR/EMF exposures for any adverse effects to wildlife. The FDA omits that it has not systematically reviewed the implications of another type of non ionizing EMF from electronic devices – magnetic field Extremely Low Frequency radiation exposure from cell phones and wireless devices used in body contact positions. The FDA omits that the Interagency RFR workgroup is defunct, and that its advisory committee on the issue has not met since 2016. 

Unless the FDA is withholding its science-based reports from the public, all of the publicly available evidence indicates that the FDA is misrepresenting its EMF activities and level of review on the issue, creating false safety assurances. It is certainly possible that the FDA has performed a robust systematic scientific review and risk assessment which has not been made public. If so, the FDA has failed to be transparent to the public and to federal agencies and elected representatives who have repeatedly requested such information. If indeed a robust systematic science based FDA risk assessment exists, it should be made public and subject to scrutiny. Until the FDA publicly releases such documentation, we believe that the FDA is misrepresenting this issue in numerous areas as details in this Declaration.

In short, the American people believe that their government is watching out for them. They believe that the FDA – the U.S. health agency with authority in regards to wireless radiation – is doing its job. This Declaration provides proof that this is not the case. 

As the legacy of asbestos, lead, and cigarettes inform us, the FDA’s failure to fully assess and mitigate risk will lead to irreversible harms for generations to come. 

Years of Misrepresentations and Haphazard Activities 

To substantiate the long history of misrepresentations by FDA staff, EHT has compiled years of personal direct email communications with FDA staff initiated by an in-person meeting between EHT’s Devra Davis, PhD and Theodora Scarato at FDA headquarters on September 23, 2014.   In that meeting, Davis and Scarato presented research linking RFR to cancer and reproductive damage, as well as case reports of young women developing unusual breast cancers directly underneath where they stored a transmitting cell phone in their bra. EHT requested that the FDA inform the public that cell phones should not be in a pocket or bra, as FCC regulatory limits would be violated. 

The subsequent email conversations over the years between Scarato and FDA staff showcase a haphazard approach by the agency, a refusal to warn the public about clear violations of FCC exposure limits, and a disregard for credible science clearly indicating harm, especially for children. The FDA clearly stated they had not performed a research review in a 2016 email and refused to answer the question of whether the FDA had reviewed the FCC limits. When the NTP released its findings in 2016 and 2018,   Scarato repeatedly requested the FDA update it’s website as it linked to 2010 information, but the FDA never did, at least until the February 2020 rewrite.  FDA Importantly, when repeatedly asked what specific levels of RFR exposure would trigger FDA’s action on the issue, and when asked to correct inaccuracies, FDA staff repeatedly refused to answer, exemplifying the haphazard activities and lack of transparency and misrepresentation. 

As additional evidence for this Declaration, EHT has collected and analyzed FDA’s letters to members of Congress, to state/local officials, and to scientists. Furthermore, we have included statements by the FCC referencing the FDA’s false safety assurances, and dismissing the National Toxicology Program study which found adverse effects in animals. The FDA’s misleading website information on cell phone radiation, and the FDA’s Dr. Shuren’s online statements, also provide critical evidence of the FDA’s misrepresentations to the public. We also have provided a short list of examples of how the wireless industry then uses the FDA verbiage to amplify the false message that safety is assured.This information is listed in  Section X. Appendix of Evidence of FDA Misrepresentations and influence on Congress, State Agencies and the Media 

The FDA Downplays the Significance of the National Toxicology Program Study Which Proves Non Thermal Effects, and Refuses to Correct the Inaccurate FDA Information on The Study

 

FDA’s Dr. Jeffrey Shuren has repeatedly stated that the FDA does not agree with the NTP study’s cancer determinations, has publicized this disagreement on the FDA website, and also in one paragraph of his April 2019 letter submitted to the FCC regarding FCC’s human exposure limits. The FDA’s rejection of the NTP study for being an “animal” study that the FDA itself nominated, displays a shockingly two-faced and hypocritical attitude to animal testing. Because every agent known to cause cancer in humans also produces cancer in animals when adequately studied, animal studies have constituted a bedrock of FDA operations for drug development and toxicology evaluation since the agency’s inception. 

Determinations based on animal studies from the 1970s and 1980s remain the sole criterion on which cell phone testing protocols have rested as documented in ANSI/IEEE C95.1-1991. Yet, when findings from state-of-the-art National Toxicology program animal studies document the damaging cumulative chronic impacts of non-thermal levels of RFR/EMF, the FDA staff rejects the study as not relevant to humans. Numerous scientists have determined that the NTP’s large scale animal studies, paired with the Ramazzini Institute research and published human studies that have found an association between cell phone use and cancer, indicate that RFR/EMF now meets criteria to be a human carcinogen.,, Children’s developing brains are more sensitive to RFR radiation and their unique physiology results in their absorption of proportionately more RFR compared to adults. 

Instead of rejecting the NTP study, many scientists argue the FDA needs to fulfill the intent of their nomination of the study to the NTP, and conduct a quantitative risk assessment from the NTP data so that the FCC can develop health-protective exposure standards. However, the FDA has not responded to the scientists who have repeatedly written to the agency regarding a quantitative risk assessment. Nor has the FDA responded to these expert scientists’ requests to correct the FDA’s inaccurate statements regarding the NTP and to be transparent about what experts were involved in the literature review that downplays the NTP study. 

FDA’s Misrepresentations Regarding Their Level of Scientific Review for Cell Phone and Radiofrequency Radiation. 

In this Declaration we break down the FDA’s misrepresentations one by one. For each misrepresentation, we document the facts confirming that the FDA’s representation is erroneous and misleading. To be clear, in this Declaration we are not making scientific arguments as to whether RFR is harmful or not, but instead we are addressing the FDA’s critical omissions and lack of honesty and transparency in its statements regarding health effects from RFR/EMF. We then follow with documentation of the far-reaching deleterious impact of these misrepresentations to public health and the environment. 

    1. Misrepresentation #1: The FDA evaluated the “totality” of scientific data to make a determination that 1. That there are no health effects from cell phone radiation and 2. That FCC Radio Frequency Radiation (RFR) limits are adequately protective and do not need to be changed.
    2. Misrepresentation #2: The FDA’s “Review of Published Literature between 2008 and 2018 of Relevance to Radiofrequency Radiation and Cancer” released in 2020 is a scientifically valid risk assessment rather than just a literature review. 
    3. Misrepresentation #3: The FDA has evaluated the science on specific non-cancer effects such as oxidative stress, impacts to reproduction and people with electromagnetic sensitivity. 
    4. Misrepresentation #4: The FDA states that “the majority of studies” do not show an association between cell phones and health problems. 
    5. Misrepresentation #5: The FDA states that RFR studies which find biological effects have not been replicated. 
    6. Misrepresentation #6: The FDA misrepresents the significance of its own sponsored $30 million U.S. National Toxicology Program (NTP) animal study findings and presents inaccurate facts regarding the study. 
    7. Misrepresentation #7: The FDA has evaluated the FCC’s human exposure limits for RFR and come to a determination that the limits are protective based on its scientific review of the limits. 
    8. Misrepresentation #8: The FDA states they “continually monitor the scientific studies” yet FDA shows no evidence of regular research monitoring nor regular scientific reviews. 
    9. Misrepresentation #9: The FDA states there is “scientific consensus” that RFR radiation is safe and safety is assured. 
    10. Misrepresentation #10: The FDA misrepresents that children and pregnant women are adequately protected by FCC RFR human exposure limits, despite no publicly available review on the risks posed by the unique vulnerability of children, pregnant women and the fetus. 
    11. Misrepresentation #11: The FDA presents to the public that cell phones are safe in body contact positions, well aware that phones in body contact positions exceed the FCC’s federal RFR exposure limits. 
    12. Misrepresentation #12: The FDA misrepresents the existence of a 50 times safety factor in relation to cell phone radiation exposure limits.
    13. Misrepresentation #13: The FDA misrepresents its level of review of 5G technology, communicating that the 5G network is safe.

Read the full Declaration of Environmental Health Trust  for details. 

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https://ehtrust.org/landmark-action-to-the-fda-on-accountability-for-cell-phone-and-wireless-radiation-safety/ Source: Environmental Health Trust