SUPPLEMENTARY INFORMATION:

Electromagnetic fields (EMFs) are energy fields produced by moving electrically charged particles and electrical currents. EMFs occur across a broad range of frequencies, including low radiofrequency (RF) associated with power systems and household appliances, as well as higher RF and microwave exposures associated with wireless communication technologies. HHS is conducting this request for information under 21 CFR subpart J.

Public concern about potential health effects from RF/EMF exposure has increased, particularly in relation to children, schools, and long-term cumulative exposure. At the same time, scientific literature is extensive, technically complex, and not always easy for policymakers or public health stakeholders to interpret. Exposure standards and regulatory approaches also vary across jurisdictions. HHS is interested in clear, balanced, and evidence-informed information about RF/EMF exposure that can support decision-making, identify research priorities, and inform practical strategies to reduce unnecessary exposure where appropriate.

Request for Information

For this RFI, HHS is seeking input from the public, including individuals, families, caregivers, healthcare professionals, public health practitioners, researchers, organizations, equipment or product manufacturers, service or infrastructure providers, and other interested stakeholders that have knowledge of or experience with RF/EMF emission and exposure. Please identify whether your response is based on peer-reviewed research, government reports, industry data, clinical observations, or other sources. If you rely on existing exposure guidelines, regulatory frameworks, or scientific assessments, please identify the specific framework(s) and explain how they inform your response. Respondents are encouraged to include supporting facts, research, datasets, technical reports, and other evidence in their comments, including citations to the published materials referenced, and active hyperlinks, where available.

Instructions

1. Responses submitted at regulations.gov/deregulation should follow the format provided there. You may respond to one or more of the questions listed below and please include question numbers provided in the response. Each responding entity (person or organization) should submit only one response. Unless submitted anonymously, responses should include the name(s) of the person(s) or organization(s) submitting the comment. If a comment is submitted on behalf of an organization, the individual respondent's role in the organization may also be provided. In your response, please describe which perspective(s) your comments represent: individual consumer, patient, family member, or caregiver; healthcare professional; equipment or product manufacturer; service or infrastructure provider; business; industry group; government; research entity; or another type of organization or perspective.

This RFI is voluntary, and responses may be submitted anonymously. Please do not submit proprietary, classified, confidential, or sensitive information, to include personally identifiable (PII) or personal health information (PHI), in response to this RFI.

This RFI should not be construed as a policy, solicitation for applications, or as an obligation on the part of the government to provide support for any ( printed page 59793) ideas in response to it. Comments submitted will become public on regulations.gov. The information provided will be analyzed and may appear in anonymized reports, on HHS websites, or otherwise released publicly. Respondents are advised that the government is not obligated to acknowledge receipt of submissions. Those submitting responses are solely responsible for all expenses associated with response preparation. HHS will use the information submitted in response to this RFI at its discretion and will not comment on any respondent's submission. However, responses to this RFI may be reflected in future solicitation(s) or policies.

Questions

Public Experiences and Reported Potential Adverse Health Effects

2. In your response, please describe which perspective(s) your comments represent: individual consumer, patient, family member, or caregiver; healthcare professional; worker with occupational exposure; equipment or product manufacturer; service or infrastructure provider; business; industry group; government; research entity; or another type of organization or perspective.

3. We invite individuals, families, caregivers, healthcare professionals, and organizations to share experiences regarding potential adverse health effects they believe may be associated with exposure to RF/EMFs. Respondents are encouraged to provide as much detail as they are comfortable sharing, recognizing that responses to this RFI will be public and therefore should not include PII or PHI. Examples of information that may be helpful to include are the following:

a. The type(s) of wireless technology or RF/EMF source(s) involved ( e.g., mobile phones, Wi-Fi, smart meters, wireless infrastructure, wearable devices, occupational equipment).

b. The nature, duration, frequency, and approximate timing of the reported exposure(s).

c. The potential adverse health effects experienced.

d. When potential adverse health effects first appeared relative to when exposure began and whether any changes in exposure coincided with potential adverse health effects.

e. Whether medical evaluation or treatment was sought, including any diagnoses received (if the respondent chooses to share them).

f. Whether steps to reduce or eliminate exposure were taken and, if so, whether any subsequent changes in potential adverse health effects were observed.

g. Any supporting documentation, including scientific reports, exposure measurements, or other relevant information.

4. We invite healthcare professionals, researchers, and public health practitioners to describe observations from clinical practice, occupational settings, or research that may help identify patterns, if any, of reported potential adverse health effects associated with RF/EMF radiation and exposure. In describing these observations, please include where available:

h. The types of potential adverse health effects reported.

i. Onset of potential adverse health effects.

j. Characteristics of the individuals or populations involved, excluding any identifying information such as PII or PHI.

k. Any observed exposure patterns.

l. What standardized methods were used to assess exposure or potential adverse health effects, if any were used.

m. Recommendations for future research or surveillance.

Exposure Standards and Risk Assessment

5. What existing national and international exposure standards, guidelines, or regulatory frameworks should federal health agencies consider when evaluating the potential adverse health effects of human exposure to RF/EMF?

n. What scientific, technical, or regulatory changes by federal health agencies, if any, would improve the assessment, disclosure, and regulation of wireless radiation exposure?

o. Is additional research needed to develop, test, and evaluate the effectiveness of procedures and techniques for minimizing exposure to electronic product radiation? Where are the largest gaps, if any, in knowledge? What research is needed to appropriately evaluate current or future national and international exposure standards, guidelines, or regulatory frameworks.

p. How, if at all, should a classification system account for exposure-related characteristics, including operating frequency, power density, specific absorption rate (SAR), electric- and magnetic-field strength, modulation and pulse characteristics, duty cycle, beamforming, simultaneous exposure to multiple frequencies, duration of exposure, distance from the source, proximity to the body, and cumulative exposure over time?

6. What scientific evidence exists about potential adverse health effects caused by current exposure limits?

Measuring Human Exposure and Public Health Surveillance

7. What scientific methods are currently available for accurately characterizing individual and population-level RF radiation exposure?

8. What, if any, improvements in exposure assessment methodologies are needed to better evaluate real-world exposure conditions?

9. What, if any, technical and exposure-related information should be disclosed to consumers, residents, workers, schools, healthcare providers, and local governments?

10. What data sources or surveillance systems currently exist to monitor potential adverse health effects associated with RF radiation exposure? Should additional data sources or surveillance systems be developed? Please discuss the benefits and challenges of the following data sources and surveillance systems, as relevant:

a. disease registries.

b. occupational monitoring.

c. environmental monitoring.

d. longitudinal cohort studies.

e. biomonitoring.

f. adverse event reporting.

g. disease or illness clusters.

h. Other.

11. Should exposure assessment or risk evaluation differ for sensitive populations such as those noted below? Please explain.

a. children.

b. pregnant women.

c. older adults.

d. individuals with implanted medical devices.

e. workers with elevated occupational exposure.

f. individuals with preexisting medical conditions.

g. Other populations that may uniquely experience potential adverse health effects in response to RF radiation.

Existing Evidence

12. What scientific evidence exists regarding potential adverse health effects associated with RF radiation exposure at levels below current federal exposure limits?

13. According to scientific evidence, how do the technologies below affect cumulative exposure patterns?

a. 5G.

b. 6G.

c. Wi-Fi.

d. Satellite-based communications.

e. Internet of Things (IoT).

f. Wearable technologies. ( printed page 59794)

g. Smart homes/appliances.

h. Smart cities.

i. Autonomous vehicles.

j. Wireless medical devices.

k. Communication enabled smart meters.

14. What scientific evidence exists regarding potential adverse environmental effects associated with RF radiation?

15. What types of scientific evidence should be considered when evaluating RF exposure associated with wireless infrastructure? Please comment on:

a. proximity to homes, schools, childcare facilities, healthcare facilities, and/or workplaces.

b. cumulative neighborhood exposure.

c. antenna density.

d. small-cell deployment.

e. livestock.

Federal Research Priorities

16. What are the highest priority research gaps regarding EMF and RF radiation and public health that the federal health agencies should address?

17. How can federal health agencies improve coordination of EMF and RF radiation research? Please comment on potential roles for federal health agencies including, but not limited to:

a. HHS Food and Drug Administration (FDA).

b. HHS National Institutes of Health (NIH).

c. HHS Centers for Disease Control and Prevention (CDC).

Additional Information

18. Please identify any additional scientific evidence, technical information, data, or recommendations that federal health agencies should consider when evaluating potential adverse health effects associated with RF/EMF radiation exposure.