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The Apple iPhone 12 Radiation Violations: FDA Failed to Address Early Reports 

The FDA was sent extensive research in 2017 (and earlier) confirming that cell phones in body contact positions violate radiofrequency (RF) radiation limits by Environmental Health Trust years ago. 

Numerous investigations and published studies have shown that when cell phones are tested in body contact positions, the radiation exposure levels will significantly exceed the U.S. FCC limits.

Gandhi 2019 examined data from 450 cell phone models from the French government agency ANFR—the national radiation assessment bureau—indicating that phones can emit 11 times over the U.S. FCC limit and 3 times over French limits in 9 out of 10 phones tested. In parallel, when laptops, computers or other wireless devices with regulatory separation are radiation tested in body contact positions, the RFR levels could violate FCC limits

When EHT’s Dr. Devra Davis and Theodore Scarato met with FDA staff at the FDA headquarters in 2014, this issue was extensively discussed. EHT shared recently published case reports of young women developing unusual breast cancers in locations underneath the antennas of the phone they had carried in their bra for years. EHT discussed how the American public was unaware that phones were not supposed to be in these close body positions—positions which allow consumers to be exposed to RFR levels that exceed the FCC’s human exposure limits. We asked the FDA to inform the public and consumers about the fact that phones should be held at a distance from the body in order to be compliant with U.S. government regulations. The FDA acknowledged that phones could exceed regulatory limits on several occasions in our communications with the FDA but did not take action. 

Here are just a few examples of the research EHT sent to FDA staff regarding cell phone radiation exposure violations. Communications went to Daniel Kassiday, William Jung, Robert Och, CDRH Ombudsman, Jeff Shuren, Mary Pastel, Robert Ochs, Michael O. Hara, Brian Beard and Bakul Patel: 

  • On June 13, 2017 Scarato shared the latest research from the government of France that found hundreds of phones exceeded radiation regulatory limits when they were tested in body contact positions (starting at page 6 Scarato/FDA emails) and asked why the FDA had not taken action to inform the public. 
  • Scarato sent the FDA the March 12, 2019 IEEE published article (Gandhi 2019) that found if the French government measurements were done with U.S. FCC protocols, some cellphone radiation emissions would violate FCC limits up to 11 times. 
  • Scarato also sent the August 21, 2019 Chicago Tribune cell phone testing data showing phones violated FCC limits at body contact
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FCCs Lack of Response to EHT/Phonegate Association Letter: December 17, 2019: EHT and Phonegate Association write members of Congress with a letter and Background and Facts document on the urgent need for a hearing regarding cell phone radiation test procedures, due to the excessive radiation the phone can expose the user to in body contact positions. 

Letters were also previously sent to the FCC on March 20, 2018.  EHT surmises a key reason the FCC took no action after these letters was that on February 2, 2018 FDA’s Shuren issued a statement that downplayed the NTP study cancer findings and took the position that cell phone radiation was safe even when exposures exceed limits due to the large safety margin. 

The FDA defends its lack of action on FCC RFR limit violations by stating there is a “large safety factor” yet cannot define what the “large safety factor” actually is. 

As an email chain between Scarato and the FDA dated May 31, 2017 details, Scarato asked, “If the FDA is supposed to protect the public then they need to inform the public of the fine print instructions in the manual related to RF. Why is the FDA not acting on this and informing people of the fine print instructions on RF on cell phones and wireless devices? Children are carrying phones on their bodies, tucked in spandex pants and in bras and jeans in school classrooms. Can you please explain why the FDA is not ensuring the public is aware of the fine print warnings?” FDA’s Kassiday responded, “There is a large safety factor included in the public exposure limit (see IEEE Std. C95.1-2005 Annex C, Rationale, for more information regarding this safety factor).”

In response to the hundreds of tests finding RFR levels exceeded in France, on October 18, 2017 (FDA Scarato emails page 15) FDA’s Kassiday wrote, “We have asked the French Agency for a discussion of their studies and findings and conclusions. However, they have not responded as of the writing of this response.” 

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When Scarato asked, “I am writing to ask if I understand correctly that the FDA believes that it is OK to exceed the regulatory limits because of this “large safety factor?” FDA’s Kassiday responded, “FDA is not saying that it is OK to exceed a regulatory limit. We stated that there is a large safety factor built into these regulatory limits.” 

On November 19, 2017 Scarato asked what exactly the FDA’s “large safety margin” was (what numerical level) in an email, “What does the FDA think the safety factor is for SAR exposure limits. Please state it.” The FDA did not respond with an actual level. 

The FDA defends the yet unknown “large safety factor” as “adequately protective.” 

In the May 31, 2017 email exchange Scarato asked the FDA why it was not informing the public about situations where cell phones will go to peak power, such as in a car. The FDA again stated, “The safety factors set in place for RF exposure adequately protect the general public.” 

 

On March 19, 2019 Scarato again also asked the FDA at what level the FDA would take action, asking, “The FDA seems to be stating in prior email exchanges that even if FCC limits are violated, they do not need to do anything…Thus, is seems there is a SAR number at which the FDA believes is safe and one that is not safe… What is the cell phone SAR measurement that the FDA has identified that would trigger the FDA to act?” Again the FDA did not respond with an actual level. 

Scarato repeatedly asked the FDA to share the RFR threshold level that would trigger the FDA to act on February 3, 2018, April 5, 2018, June 2, 2018, June 11, 2018, November 6, 2018, March 2019 and several other dates but has never received a response that included the actual level that would trigger FDA action.

The FDA’s only response to the question of the safety margin was talking about the 50-fold safety limit whole-body FCC limits. However this is not the regulatory limit for cell phone compliance and thus the FDA did not answer the question in regards to local tissue cell phone RFR exposure limits. 

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The FDA knowingly allows the American public to be exposed to RFR levels in excess of the regulatory limit. Scarato stated to the FDA (Page 35 FDA Scarato Emails), “Everyone I have spoken to is 100% unaware of this information buried in manuals. Please explain how the FDA has decided it is not their responsibility to inform the public on this.” 

The FDA’s Kassiday responded:

As any web search for “usability of user manuals” will reveal, there is a lot of concern and research on why most consumers ignore manuals and instructions. So it is not surprising that consumers are unaware of one particular fact in a manual when most consumers don’t read anything in user manuals. The FDA has not done a survey and we are not aware if the FCC has.”

As shown in the preceding evidence, the FDA is aware that FCC limits are exceeded and defends its lack of action because of a “large safety margin” yet cannot answer how large the safety margin is nor at what RFR level past the U.S. regulatory limit the FDA would act. The FDA is aware that the public does not read their manuals and was provided evidence that people put phones in body contact positions. The FDA also misrepresents that it knows that the “large safety factor” itself (in addition to the FCC limits) protects the general public but shows no review of recent research on RFR safety factors to determine this level. 

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https://ehtrust.org/apple-iphone-12-radiation-violations-fda-failed-to-address-early-reports/ Source: Environmental Health Trust