CITIZEN PETITION: Submitted under 21 C.F.R. § 10.30 * RF SAFE® Radio Frequency Safe

CITIZEN PETITION
Submitted under 21 C.F.R. § 10.30

Petitioner:
[Your Full Legal Name]
[Street Address]
[City, State, ZIP]
[Email] | [Phone]

Date: [Month Day, 2025]

To:
Dockets Management Staff (HFA‑305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

(Or submit electronically via Regulations.gov as a Citizen Petition to FDA/CDRH.)

A. Action Requested

Petitioner respectfully requests that the Food and Drug Administration (FDA), acting through the Center for Devices and Radiological Health (CDRH) and pursuant to the Electronic Product Radiation Control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. §§ 360hh–360ss, take the following actions:

Make a formal necessity determination under 21 U.S.C. § 360kk
Within 90 days, determine whether federal performance standards are “necessary for the protection of the public health and safety” for radiofrequency (RF)‑emitting consumer electronic products, including at minimum: mobile phones, tablets, wearable devices, laptops/tablets with cellular radios, cordless phones, and consumer Wi‑Fi/BT access devices (“Covered Products”).
- In making this determination, consider the latest scientific and medical data (including WHO‑commissioned 2024–2025 systematic reviews, the National Toxicology Program’s 2018 findings, and other peer‑reviewed evidence attached).
Initiate a rulemaking under § 360kk to prescribe performance standards for Covered Products
Within 120 days, publish a Notice of Proposed Rulemaking (NPRM) (or an ANPRM with a firm NPRM date) prescribing performance standards that address exposure control, testing, design, labeling, and user information for real‑world exposures, including pulsed/modulated signals, body‑contact use, child and pregnancy‑relevant scenarios, and whole‑body and localized absorption.
- Consult TEPRSSC: Schedule the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) review within 90 days, and include TEPRSSC’s recommendations in the preamble.
- Core elements to propose (non‑exhaustive; final content after TEPRSSC consultation):
  a. On‑body/0‑mm test conditions and test geometries reflecting real‑world carry (pockets, waistband, bra, armband), including abdomen‑adjacent positions relevant to pregnancy;
  b. Proximity‑sensing / power‑reduction requirements for contact and near‑contact modes;
  c. Waveform‑aware metrics that capture pulsation/modulation and peak exposures (not only long averaging windows), with duty‑cycle and crest‑factor constraints;
  d. Time‑averaging rules that avoid masking biologically relevant peaks;
  e. Child‑protective factors (e.g., smaller head/pinna anatomy; pediatric default settings/controls);
  f. Labeling and user information, including explicit on‑body‑use instructions, separation distances, and pediatric/pregnancy advisories;
  g. Post‑market surveillance/adverse‑event reporting pathways for RF‑related complaints.
Reestablish and publish the EPRC research program plan under 21 U.S.C. § 360ii
Within 90 days, publish a five‑year RF bioeffects research plan that “plans, conducts, coordinates, and supports” ongoing research, with annual public updates, including:
- Non‑thermal endpoints, long‑term and pulsed/modulated exposures, prenatal/pediatric windows of vulnerability;
- Representative modern signals (LTE/5G NR sub‑6 & mmWave; Wi‑Fi; DECT; BT) with realistic duty cycles and co‑exposures;
- Blinded pathology and transparent data access.
  Coordinate with NIEHS/NTP and extramural partners; specify funding lines and timelines.
Quarterly public status reports
Beginning 90 days from the date of this petition and quarterly thereafter until final rule issuance and full research program activation, publish status reports describing progress on the § 360kk rulemaking, TEPRSSC activities, § 360ii research plan execution, and interagency coordination.
Place all materials in a public docket
Docket this petition and all supporting exhibits and subsequent agency responses to ensure a transparent administrative record accessible to the public and to other agencies, including the FCC’s ongoing remand process.

B. Statement of Grounds

1. Statutory framework and FDA authority/duty

Congress enacted the EPRC provisions (FD&C Act Subchapter C, 21 U.S.C. §§ 360hh–360ss) to protect the public from electronic product radiation, including non‑ionizing forms. The statute is mandatory in key parts:

Program & research (21 U.S.C. § 360ii): The Secretary “shall establish and carry out” an electronic product radiation control program and “shall … plan, conduct, coordinate, and support research” and publish findings as part of that program.
Performance standards (21 U.S.C. § 360kk): The Secretary “shall by regulation prescribe performance standards” for electronic products if he determines such standards are necessary to protect public health and safety; in doing so, he must consider “the latest scientific and medical data,” consult TEPRSSC, and describe the need and appropriateness of the standard.
Savings clause: The statute is not construed to supersede or limit other federal agencies’ functions (e.g., FCC spectrum/device authorization). That clause preserves FDA’s own authorities; it does not subtract them.

2. Factual context and regulatory gap

The National Toxicology Program (2018) reported “clear evidence” of malignant schwannomas of the heart and some evidence for gliomas in male rats exposed to 2G/3G RF—establishing a strong hazard signal in animals.
WHO‑commissioned systematic reviews (2024–2025) strengthened the animal cancer signal (high‑certainty for gliomas and cardiac schwannomas) and, following a 2025 corrigendum, reported detrimental effects on male fertility (e.g., reduced pregnancy rates when exposed males mate with unexposed females), with upgraded certainty.
Human pregnancy/child outcomes: Observational cohorts (e.g., 2025 studies) report adverse associations (miscarriage; growth outcomes) tied to phone/cordless usage duration; exposure assessment remains imperfect but the direction of effect heightens the need for precaution and better federal research.
Program stall: Public statements indicate NTP/NIEHS has no current plans for additional RFR animal studies. This leaves EPRC’s § 360ii research mandate unfulfilled in a period of rapidly evolving consumer RF technology.
Testing/labeling gap: Current consumer‑device testing often uses separation distances and time‑averages that do not reflect on‑body/0‑mm use, pulsed/modulated peaks, or pediatric anatomies—conditions central to real‑world exposure.

3. Necessity for performance standards (triggering § 360kk)

Given the weight of animal evidence (cancer and male fertility), concerning human observational signals in pregnancy/child outcomes, known biophysical mechanisms (e.g., voltage‑gated channel perturbation and oxidative stress under pulsed/modulated fields), and the ubiquity of close‑to‑body exposures, performance standards are necessary to protect public health. The standards should:

Make on‑body/0‑mm scenarios the default test mode;
Address pulsation/modulation and peaks explicitly;
Require proximity‑sensing/power management to limit emissions in contact/near‑contact modes;
Incorporate child‑protective and pregnancy‑relevant factors;
Mandate clear labeling/instructions for the public.

4. Statutory duties are ongoing and time‑sensitive

EPRC’s research mandate is ongoing (“shall … plan, conduct, coordinate, and support”). Failure to maintain a credible, modern research program—particularly after the 2018 NTP findings and newer WHO syntheses—frustrates the statute’s purpose and deprives the public and sister agencies of current science. Prompt § 360kk rulemaking, preceded by TEPRSSC consultation and paired with a transparent § 360ii research plan, is both lawful and necessary.

5. Requested timelines are reasonable

The requested 90/120‑day milestones are process milestones (necessity determination; TEPRSSC scheduling; ANPRM/NPRM publication; research plan publication) and do not predetermine the substance of the standards. They ensure FDA fulfills discrete statutory obligations in reasonable time and provides the public a transparent path forward.

C. Environmental Impact

Pursuant to 21 C.F.R. part 25, Petitioner claims a categorical exclusion because the requested actions (agency determinations, rulemaking initiation, and research planning) are of a type that do not individually or cumulatively have a significant effect on the human environment, and no extraordinary circumstances are known. If FDA determines that an Environmental Assessment (EA) is required, Petitioner will promptly submit an EA.

D. Economic Impact

Per 21 C.F.R. § 10.30(b), economic impact information will be submitted if requested by the Agency.

E. Certification

The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.

[Signature (typed is acceptable for e‑filing)]
[Your Name]

Suggested Exhibits (attach PDFs where possible)

Exhibit A. Statutory excerpts: 21 U.S.C. §§ 360hh–360ss (highlight § 360ii and § 360kk).
Exhibit B. NTP (2018) RF final reports (TR‑595 etc.) and fact sheets summarizing “clear evidence” (male rat heart schwannomas) and “some evidence” (gliomas).
Exhibit C. NIEHS/NTP public page/fact sheet noting no current plans for additional RFR animal studies.
Exhibit D. WHO‑commissioned systematic review (2025) on cancer in experimental animals (high‑certainty for gliomas and cardiac schwannomas).
Exhibit E. WHO‑commissioned male‑fertility review (2024) and 2025 corrigendum changing “possible detrimental effect” to “detrimental effect,” with pooled estimates.
Exhibit F. Human pregnancy/child outcomes cohort(s) (e.g., BMC Pregnancy & Childbirth, 2025 Yazd cohort).
Exhibit G. Mechanistic reviews on pulsed/modulated RF and VGIC/VGCC/oxidative stress pathways.
Exhibit H. D.C. Circuit (2021) opinion remanding FCC’s 2019 decision (for context on interagency reliance on HHS science).
Exhibit I. Declarations (28 U.S.C. § 1746) from affected individuals (pregnancy/child exposure; device carry) and experts.
Exhibit J. Any FDA/FCC MOUs or guidance showing FDA’s health‑science role for RF‑emitting products.
Exhibit K. Proposed TEPRSSC questions and a draft outline of performance‑standard elements.

Tip: Put each exhibit in a clearly labeled PDF. Include a short index of exhibits at the beginning of your submission.

Optional Appendix (helps the Agency and shows seriousness)

Appendix 1 — Draft outline for a new 21 C.F.R. Part [1041] “Performance Standards for RF‑Emitting Consumer Electronic Products”

§ 1041.1 Scope (Covered Products)
§ 1041.3 Definitions (on‑body use, proximity sensing, pulsed/modulated peak, duty cycle, crest factor)
§ 1041.5 Exposure Performance Requirements (on‑body/0‑mm mode limits; child/pregnancy factors; peak constraints)
§ 1041.7 Test Methods (phantoms/geometries, time windows, waveform‑aware metrics, worst‑case placements, small‑head models)
§ 1041.9 Design Controls (automatic power reduction in contact modes; default settings)
§ 1041.11 Labeling (clear on‑body instructions; pregnancy/child advisories; separation guidance)
§ 1041.13 Post‑market Surveillance (complaint handling; adverse‑event reporting pathway)
§ 1041.15 Compliance Dates (phased‑in timelines; legacy device labeling update)

Filing Instructions (practical)

E‑file on Regulations.gov: Create a PDF titled “Citizen Petition — RF Performance Standards and Research Program (21 U.S.C. §§ 360ii, 360kk)”. Upload the petition and each exhibit. Select FDA as the agency and choose the Citizen Petition option if available.
Or mail to Dockets Management Staff (address above). Put “CITIZEN PETITION” at the top of the cover page.
Keep proof of submission (Regulations.gov confirmation or mail receipt).
FDA must respond within 180 days (approve, deny, dismiss as moot, or issue a tentative response). If FDA delays or declines without a reasoned basis, you will be positioned to seek APA § 706(1) relief (to compel action within a reasonable time) and, if necessary, § 706(2)(A) review of any denial as arbitrary and capricious.