Please support the Citizen's Petition by submitting a comment to the FDA and passing this on to other concerned individuals.

Please support the Citizen's Petition by submitting a comment to the FDA and passing this on to other concerned individuals.

Pharmacists Planning Service, Inc. (PPSI), which originated "The Great American Smoke-out" campaign, submitted a Citizen's Petition to the FDA asking "For Public Hearings to establish standards on cellphone radiation adverse health effects that might be caused by specific absorption rates (SAR) and radio frequency radiation (RFR)/electromagnetic frequency (EMF)"  and requesting the addition of health warnings to wireless consumer devices. (http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;D=FDA-2013-P-1374 or go to http://www.regulations.gov  and search for the docket number FDA-2013-P-1374.  This website can be slow, please be patient, or try back at a lower use time.)

Background:

The FDA has an obligation to regulate safety of radiation emitting consumer devices.  “Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation.”

http://www.fda.gov/Radiation-EmittingProducts/FDARadiologicalHealthProgram/ 

http://www.fda.gov/radiation-emittingproducts/electronicproductradiationcontrolprogram/gettingaproducttomarket/default.htm 

http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/default.htm 

FDA states: “To accomplish the mission of the radiological health program, CDRH:

• Maintains awareness of new and existing radiation-emitting products, their manner of use, and their manufacturers;
• Studies the biological effects of radiation-emitting products and their potential risks to health;
• Assesses radiation emission levels from products in various applications;
• Provides direction and guidance to the general public and users of radiation-emitting products to minimize unnecessary radiation exposure; and
• Oversees product manufacturer compliance with all applicable requirements and pursues regulatory and enforcement action to address public health problems.”

There is ample evidence that wireless consumer devices, including cellphones, cordless phones, wifi enabled devices are potentially harmful or dangerous.  Therefore, wireless devices should feature a warning label prominently on both the packaging and the device in at least 12 point font while consideration is given to whether they should be withdrawn from the market.  

Points to include in your letter of support:

• Absence of regulatory action by the FDA provides the public with a false sense of the safety of wireless devices, causing harm to individual and public health.

• Many wireless device companies, and even governmental bodies, disclaim responsibility for the actual safety of radiation emitting products they manufacture or use based on FDA and FCC regulatory obligations to ensure safety. 

• The existence of a large body of evidence (www.bioinitiative.org) documenting that exposure to the pulsed modulated radiation from wireless devices has multiple detrimental health impacts and functionally impairs multiple key cellular and bodily processes and the absence of FDA regulatory action suggests negligence on the part of the FDA with regard to their duties, listed above.

• Therefore, the FDA has a legal obligation to immediately review the literature showing harmful or potentially harmful biological effects caused by exposure to radiation emitting consumer devices in order to protect consumer health and safety, as well as the public health.

• The RF radiation literature and anecdotal evidence of harm from wireless devices leaves the FDA with only one responsible course of action:
• Immediately take action to require placement of clearly visible warning labels in at least 12 point font on the outside of packaging and on the device itself. 
• Begin evaluating whether the devices should be withdrawn from the market due to the safety hazard they pose.

• Please support FDA use of this sample warning label in the event they do not withdraw the products:

WARNING: This device emits pulsed modulated microwave radiation.  Avoid exposing pregnant women and children.  Radiation from wireless devices is classified as a **insert current WHO classification for radiofrequency radiation, currently -  class 2B possible** carcinogen by the World Health Organization (WHO).  Radiation from wireless devices can cause irreversible DNA damage and also significantly reduce fertility.  Radiation from wireless devices is known to cause hotspots within living tissue which can cause irreversible damage.  Long-term exposure to microwave radiation is associated with neurological disorders, endocrine disruption, cardiac arrhythmias, and functional impairment of numerous bodily systems.

Supporting evidence for this warning label can be found at: www.bioinitiative.org, “CRITICISM OF THE HEALTH ASSESSMENT IN THE ICNIRP GUIDELINES FOR RADIOFREQUENCY AND MICROWAVE RADIATION (100 kHz - 300 GHz)” (http://www.neilcherry.com/documents/90_m4_EMR_ICNIRP_critique_09-02.pdf), and Cellular Telephone Russian Roulette: A Historical and Scientific Perspective (http:// microondes.files.wordpress.com/2010/03/robert_c_kane_cellular_telephone_russian_roulette.pdf), to name a few.

• The often involuntary, but still harmful, nature of second-hand exposures to radiation from wireless consumer devices supports the need for withdrawal of wireless radiation emitting devices from the market.  Please support briefly with evidence from your experience and studies.  It is very important to put a face on the issue and ground the effects discussed in scientific papers in reality.  Discuss the impairment of civil and human rights.

• FDA does not regulate the emissions of communications towers.  However, FDA should request that Congress and the President fund the EPA to modernize the radiofrequency radiation limits, making them biologically-based and public health protective, and also require the FCC to adopt and enforce the updated limits.  Personal wireless devices require communication towers, which involuntarily expose vast swaths of the population to pulsed microwave radiation, in order to function.  The Department of Interior statement that ““the electromagnetic radiation standards used by the Federal Communications Commission (FCC) continue to be based on thermal heating, a criterion now nearly 30 years out of date and inapplicable today.” (http://www.saferemr.com/2014/03/dept-of-interior-attacks-...) and The BioInitiative Report (www.bioinitiative.org),  along with numerous reports of harm, provide sufficient evidence to support the need for modernizing the RF limits. 

Directions for submitting a comment:

1. In the header of your comment please put - Comment on Docket FDA-2013-P-1374-0001
2.  Go to http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;D=FDA-2013-P-1374 (copy link and paste in browser)   or go tohttp://www.regulations.gov  and search for the docket number FDA-2013-P-1374  (This website can be slow, please be patient, or try back at a lower use time. )
3. Click “Comment Now” by FDA-2013-P-1374-0001
4. Submit comment - you can either upload a pdf or paste a document that is less than 5000 characters.
5. Be sure to print your confirmation for your records.

Sent from a hardwired computer in a low rf environment