2015 Revisions to Safety Code 6: Summary of Consultation Feedback

Background - Updating Safety Code 6

Health Canada's mandate regarding human exposure to radio-frequency (RF) electromagnetic energy from wireless equipment is to carry out research into possible health effects, monitor the scientific literature related to such effects, and develop exposure guidelines such as the Limits of Human Exposure to Radiofrequency Electromagnetic Energy in the Frequency Range from 3 kHz to 300 GHz - Safety Code 6. While Health Canada sets exposure limits for RF energy in federal settings, it does not regulate exposure to RF energy for the general public. Industry Canada is the federal agency responsible for regulating wireless communications equipment (e.g. cell phones, cell sites, smart meters, Wi-Fi) in Canada. To ensure that public exposures fall within acceptable guidelines, Industry Canada has developed regulatory standards that require compliance with the human exposure limits outlined in Safety Code 6.

Health Canada scientists monitor the scientific literature on this issue on an ongoing basis and Safety Code 6 is periodically updated to take into account recent scientific data from studies carried out worldwide. The limits recommended for general public exposure to RF energy are designed to provide protection for all age groups, including infants and children, on a continuous basis. When developing the exposure limits in Safety Code 6, Health Canada scientists consider all peer-reviewed scientific studies and employ a weight-of-evidence approach. The weight-of-evidence approach takes into account both the quantity of studies on a particular endpoint (whether adverse or no effect), and, more importantly, the quality of those studies. Poorly conducted studies (e.g. inadequate exposure evaluation, lack of appropriate control samples or inadequate statistical analysis), receive relatively little weight, while properly conducted studies (e.g. all controls included, appropriate statistics, complete exposure evaluation) receive more weight. On the basis of this approach, Health Canada scientists have established limits for safe human exposure to RF energy that are based on the best available scientific evidence and that incorporate a wide margin of safety.

A revised update to Safety Code 6 was prepared in 2013 to ensure that the most up-to-date and credible scientific studies on the potential effects of RF energy on human health are reflected in the code. Health Canada had proposed changes to Safety Code 6 based on the latest available scientific evidence, improved modeling of the interaction of RF fields with the human body and to align with exposure limits specified by the International Commission on Non-ionizing Radiation Protection (ICNIRP). These changes were to ensure that wide safety margins are maintained to protect the health and safety of all individuals, including children.

Further to the House of Commons Standing Committee on Health recommendations published in December 2010, Health Canada contracted the Royal Society of Canada (RSC) to review the results of emerging research relating to the safety of RF energy on human health to ensure it is reflected in the revised Safety Code 6 through a formalized expert panel process. The Expert Panel of the RSC released their review in March 2014, concluding that, in the view of the Panel, there are no established adverse health effects at exposure levels below the proposed limits. Among the recommendations made by the RSC, it was suggested that the proposed reference levels in the draft Safety Code 6 be made slightly more restrictive in some frequency ranges to ensure larger safety margins for all Canadians, including newborn infants and children. This recommendation took into account recent dosimetry studies, one of which became available since Health Canada developed the draft update to Safety Code 6 examined by the RSC. Feedback received from the RSC as a result of their Expert Panel review has been incorporated into the latest revised Safety Code 6.

Public Consultation and Feedback

Health Canada is committed to transparency and openness in its decision-making process and is aware of public interest in issues related to RF energy. Between May 16 and July 15, 2014, Health Canada undertook a 60-day public consultation period for the proposed revisions to Safety Code 6. The Department welcomed feedback from interested Canadians and stakeholders, however, given the scientific basis of the Guideline, only feedback of a technical/scientific nature could be considered in the finalization of Safety Code 6.

During the 60-day consultation period, over 450 submissions were received from various respondents. A breakdown of the respondent profile is provided in the following table:

Table 1. Respondent Profile

Respondent Type	Number of Respondents *
Individuals	284
Manufacturers	2
Industry Associations	6
Educational Boards/Institutions	1
Utilities	1
Environmental Health Awareness Groups	6
Other Organizations	1
* Note that some respondents provided multiple submissions

While only feedback of a scientific nature was solicited through the consultation, nearly one-third of the comments and references received were non-scientific in nature, such as personal accounts, websites, blogs, and media stories. In the interest of openness and transparency, Health Canada is responding to both scientific and non-scientific comments received.

Health Canada wishes to thank the many interested individuals and organizations for their time and effort in consideration of this issue.

The following summary should be read in conjunction with additional material available on the Health Canada website, Understanding Safety Code 6: Health Canada's radiofrequency exposure guidelines.

A. Scientific Feedback

Technical comments received can be organized in the following themes:

1. Consideration of Specific Scientific Studies
2. Harmonization of the Peak Specific Absorption Rate (SAR) Limits in Safety Code 6 with Existing Standards
3. Low Frequency Magnetic Field Reference Levels
4. Other Scientific Feedback

1. Consideration of Specific Scientific Studies

A large number of submissions raised concerns suggesting Health Canada had not considered all of the relevant scientific literature when updating Safety Code 6.

A large number of consultation respondents provided Health Canada with scientific literature for consideration. Department officials have reviewed all scientific studies submitted from the public consultation process. Health Canada has also considered other studies in the scientific literature which were not submitted during the public consultation process, including both original studies that meet quality standards along with recent reviews of this literature by several national health agencies and organizations such as the World Health Organization (WHO), France's Agency for Food, Environmental and Occupational Health & Safety (ANSES), the United Kingdom's Advisory Group on Non-Ionizing Radiation (AGNIR), the European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) and the International Commission on Non-ionizing Radiation Protection (ICNIRP).

While Safety Code 6 (2015) references a number of large international reviews of the scientific literature, the Code is intended as an exposure guideline and not a scientific review article and accordingly, most individual scientific studies are not referenced in the Code. However, this does not mean that Health Canada did not consider all relevant scientific information when deriving the science-based exposure limits in Safety Code 6.

It is important to note that when thousands of research studies are conducted on any test agent (e.g. RF fields), statistical chance dictates that a small number of studies (even if conducted properly) will demonstrate a 'false positive' or 'false negative' result. Furthermore, studies with inappropriate study design or methodology can lead to erroneous results that are scientifically meaningless. It is for these reasons that the scientific literature on a given test agent must be evaluated both for the quality of the studies conducted but also for the strength of the evidence. Such analysis must consider all relevant properly conducted studies on the test agent. While some studies have reported biological effects or adverse health effects of RF fields at levels below the limits in Safety Code 6, these studies only form part of the dataset and do not represent the prevailing line of scientific evidence in these respective areas. Similar conclusions have been reported in recent reviews of the scientific evidence by national and international health authorities.

2. Harmonization of the Peak Specific Absorption Rate (SAR) Limits in Safety Code 6 with Existing Standards

A number of comments received suggested that Health Canada should harmonize Safety Code 6 with international standards developed by the Institute of Electrical and Electronics Engineers (IEEE) or the International Commission on Non-Ionizing Radiation Protection (ICNIRP).

Specific absorption rate (SAR) is a measure of the rate at which energy is absorbed by the human body when exposed to RF electromagnetic fields. The limit specified by ICNIRP (1998) and IEEE C95.1 (2005), for the uncontrolled environment, is 2.0 W/kg within any 10 g of tissue for the head, neck and trunk. The corresponding peak spatially-averaged SAR limit in Health Canada's Safety Code 6 is specified as 1.6 W/kg within any 1 g of tissue for the head, neck and trunk. Health Canada has considered these comments, but has retained the more restrictive limits as they provide more protection against the occurrence of small regions with thermal hotspots. Furthermore, there remains uncertainty regarding the possible long-term health risks associated with cell phone use. Therefore, the basic restriction for the peak spatially-averaged SAR limit in Safety Code 6 (2015) will remain unchanged at 1.6 W/kg within any 1 g of tissue to maintain an additional margin of safety.

Furthermore, the choice of a 1.6 W/kg within any 1 g of tissue SAR limit is consistent with the SAR limit utilised in the United States by the Federal Communications Commission (FCC).

3. Low Frequency Magnetic Field Reference Levels

Comments were received suggesting that the low frequency reference levels for magnetic fields (3 kHz to 10 MHz) proposed in Safety Code 6 were overly restrictive.

Typical devices that utilize this low frequency bandwidth are induction cooktops, AM radio, and electronic article surveillance (EAS) technologies. Based upon analysis of the technical comments received during the public consultation process, Health Canada re-calculated the reference levels of the magnetic field range (3 kHz to 10 MHz) to make sure they were aligned with internal quantities i.e., basic restrictions, on which the reference levels were based. Health Canada concluded that there was scientific merit to the comment stating that the proposed reference levels did not correspond to their equivalent basic restrictions. As such, Health Canada has corrected the magnetic field strength reference levels to correspond with the basic restrictions, resulting in uncontrolled- and controlled-environment reference levels of 90 and 180 A/m, respectively.

4. Other Scientific Feedback

Numerous submissions were received on other technical aspects:

• Consideration of non-thermal effects
• Clarification of six minute averaging time
• Cumulative effects from multiple RF sources
• Comparison to more restrictive standards adopted internationally
• RF energy as a possible carcinogen

These concerns have been previously addressed by Health Canada in the documents Understanding Safety Code 6: Health Canada's radiofrequency exposure guidelinesas supplementary information material for the consultation process. Health Canada's response on these technical aspects is contained within these documents.

B. Non-Scientific Feedback

In addition to the scientific feedback received, several non-scientific submissions were received, including comments that sought clarification on the purpose and methodology applied used in deriving Safety Code 6. Such comments related to:

1. Application of Safety Code 6
2. Safety Code 6 and medical devices
3. Relevancy of a 200 lb mannequin to children or women
4. Recognition of electromagnetic hypersensitivity
5. International scientific best practices
6. The Royal Society of Canada's Expert Panel
7. Regulations on cell tower placements, public Wi-Fi installation, and smart meter installation
8. Application of the precautionary principle

1. Application of Safety Code 6

Some comments received revealed misunderstandings related to the scope and application of Safety Code 6. Specifically, comments questioned Health Canada's enforcement of the Code as a regulatory instrument and/or its applicability in relation to the placement of wireless devices (e.g., smart meters, Wi-Fi, cellular towers) in Canada.

Safety Code 6 is a guideline, based on scientific evidence, which recommends limits for safe human exposure to RF electromagnetic energy in the frequency range of 3 kHz to 300 GHz. The limits established in Safety Code 6 incorporate large safety margins to provide a significant level of protection for all Canadians, including those working near RF sources. The safety limits in this code apply to all individuals working at, or visiting, federally regulated sites. Safety Code 6 itself is not a regulation; it is a health and safety guideline. Other federal departments (e.g., Industry Canada, National Defence, Employment and Social Development - Labour Program) and provinces/territories may adopt and/or enforce all or parts of Safety Code 6 under their respective regulatory authorities.

2. Safety Code 6 and medical devices

Comments suggested that Safety Code 6 should provide protection to cover exposures from all devices that emit RF fields, including medical devices.

Safety Code 6 does not cover deliberate exposure of RF energy to medical patients or personal operating magnetic resonance imaging (MRI) or other RF-emitting medical equipment. Such protections are already provided by adherence to international guidelines or by guidelines published by provincial health ministries.

In Canada, medical devices are regulated under the Food and Drugs Act. A list of standards recognised by Health Canada for electromedical devices is available at: Proposed Changes to the Therapeutic Products Directorate’s List of Recognized Standards for Medical Devices

3. Relevancy of a 200 lb mannequin to children or women

Comments suggested that Safety Code 6 is based on the use of a 200 lb mannequin, representative of an adult male, which does not relate to exposures by children or women.

The Safety Code 6 limits for human exposure to RF energy are designed to provide protection for all age groups, including children, on a continuous (24 hours a day/seven days a week) basis. Full consideration of adverse health effects and dosimetry for various body sizes and ages (including infants and children) were considered when developing Safety Code 6. This means that if someone, including a small child, were to be exposed to RF energy from multiple sources for 24 hours a day, 365 days a year, within the Safety Code 6 limits, there would be no adverse health effects. The use of a 200 lb mannequin (often used for assessing the compliance of cell phones) is unrelated to the development of the human exposure limits in Safety Code 6.

4. Recognition of electromagnetic hypersensitivity

Comments received provided details of suffering from symptoms attributed to Electromagnetic Hypersensitivity (EHS) disorder, specifically requesting recognition of this disorder for the purpose of revising Safety Code 6.

A number of people have described an assortment of health symptoms that they attribute to exposure to electromagnetic fields. Health Canada agrees with the World Health Organization's (WHO) position that the symptoms described by those reportedly suffering from EHS, also known as idiopathic environmental intolerance attributed to electromagnetic fields (IEI-EMF), are real, but that scientific evidence has failed to demonstrate that the EHS symptoms are caused by electromagnetic fields.

5. International scientific best practices

Comments received specifically requested that Health Canada follow international scientific best practices in its review of Safety Code 6.

The scientific approach used to establish the exposure limits in Safety Code 6 is comparable to that employed by other international health agencies and standards bodies, such as the International Committee on Non-Ionizing Radiation Protection (ICNIRP) and the Institute of Electrical and Electronic Engineers (IEEE). As such, the basic restrictions in Safety Code 6 are based on the best available scientific evidence and are consistent with those adopted by most other nations, since all science-based, standard-setting bodies use the same scientific data.

In 2006, the WHO published a document entitled Framework for Developing Health-based EMF Standards. The Framework provides advice on how to develop science-based limits that will protect the health of the population from exposure to electromagnetic fields (EMFs). Health Canada's approach is consistent with this Framework.

6. The Royal Society of Canada Expert Panel

Comments received pertained to the Royal Society of Canada's Expert Panel process.

The Royal Society of Canada (RSC) is Canada's national academy which exists to promote Canadian research and scholarly accomplishment, to recognize academic and artistic excellence, and to advise governments, non-governmental organizations and Canadians on matters of public interest. With its well-known experience in convening expert panels to provide independent advice, notably to government on matters of public policy through its program of Expert Panel reports, the RSC was chosen as the most appropriate body to conduct the assessment of the Department's review of Safety Code 6.

Health Canada is aware of concerns raised with regards to the Expert Panel selection process. The RSC has detailed conflict of interest guidelines to support decision-making respecting individuals' participation on expert panels. Prospective panelists are required to complete declaration forms outlining any issues that might give rise to a real, apparent or potential conflict of interest in relation to their official duties. Specific considerations are given to the following categories: individual economic impact; proprietary information; public statements and positions; access to government information; reviewing one's own work; and employment by a sponsoring agency. Conflict of interest policies often acknowledge that the existence of such considerations does not in itself establish that the individual is in conflict. All queries regarding this process should be made directly to the RSC.

7. Regulations on cell tower placements, public Wi-Fi installation, and smart meter installation

Comments received requested Health Canada's involvement in the location of cellular phone towers, the placement of Wi-Fi in public places, and the installation of Smart Meters.

Industry Canada is the federal agency responsible for regulating wireless communications equipment (e.g. cell phones, cell sites, smart meters, Wi-Fi) in Canada. The placement of Wi-Fi in non-federally regulated workplaces (e.g., schools, restaurants, public areas) is regulated under provincial/territorial regulations, or, in some provinces, by delegated authority to municipalities. While smart meter technology is regulated by Industry Canada, such installations are provincially/territorially regulated. Health Canada does not have any mandate regarding such placements.

8. Application of the precautionary principle

Comments received suggested that the precautionary principle be applied to the human exposure limits in Safety Code 6, including reductions of 100 to 1000 times.

Health Canada, as with other federal departments and several regulatory agencies worldwide, applies the precautionary principle as a public policy approach for risk management of possible, but unproven, risks to health. A precautionary approach to decision-making emphasizes the need to take timely and appropriately preventative action, even in the absence of a full scientific demonstration of cause and effect.

The precautionary principle is not a tool for risk assessment. Risk assessments consider all data available in the scientific literature and focus on effects which scientists consider most relevant for human health and based on such an evaluation the Department will take action as required. In the case of electromagnetic fields, there is sufficient evidence supported internationally to show that adherence to the recommended levels of exposure in Safety Code 6 will not cause harm to health.

Within Safety Code 6 a conservative approach has been used when establishing the thresholds for established adverse health effects (whether nerve stimulation or tissue heating). At the threshold for the occurrence of these effects, only mild alterations from homeostasis would occur that do not result in any known long-term or cumulative adverse health consequences. Thus, the threshold effects to be avoided are of minimal health significance and are of a conservative nature. When the basic restrictions are applied to provide safety margins from the occurrence of these effects, additional conservative measures are also applied. A 10-fold reduction is applied for the avoidance of nerve stimulation, while a 50-fold reduction is applied for the avoidance of thermal effects in the uncontrolled environment. Furthermore, when the reference levels are derived for ensuring that external RF field levels do not exceed the basic restrictions within the body, worst-case exposure scenarios have also been applied. Factors such as worst-case body size relative to a given frequency (including adult and child body sizes), orientation of the fields to the body, body posture and prolonged exposure in the same position have been applied for deriving the reference levels. These exposure scenarios are considered to be extremely unlikely to occur under any circumstance in either controlled or uncontrolled environments for either adults or children. Therefore, an additional significant margin of protection has been applied to the reference levels.