By Federal Communications Commission.
As many should know people that have mobile phones, lap tops and other technologies are encountering serious problems with magnetic radiation that the Federal Communications Commission does not know how to regulate without lobbyist.
SUMMARY: This document resolves several issues regarding compliance with the Federal Communications Commission’s (FCC’s) regulations for conducting environmental reviews under the National Environmental Policy Act (NEPA) as they relate to the guidelines for human exposure to RF electromagnetic fields. More specifically, the Commission clarifies evaluation
procedures and references to determine compliance with its limits, including specific absorption rate (SAR) as a primary metric for compliance, consideration of the pinna (outer ear) as an extremity, and measurement of medical implant exposure. The Commission also elaborates on mitigation procedures to ensure compliances with its limits, including labeling and other requirements for occupational exposure classification, clarification of compliance responsibility at multiple transmitter sites, and labeling of fixed consumer transmitters.
Summary of Report and Order
1. This Report and Order (Order) resolves issues raised in the 2003 Notice of Proposed Rulemaking, (NPRM), specifically certain evaluation matters involving the determination of potential exposure levels by calculation or measurement and certain mitigation matters involving post-evaluation procedures to ensure exposure limits are not exceeded (such as labels, signs,
barriers, enforcement, and occupational issues.
a. Evaluation of RF Exposure
2. Currently, “routine environmental evaluation” is described in the Commission’s rules as “determination of compliance” with its exposure limits, which could be achieved by either computation or measurement. Methods for evaluation of compliance include computation and measurement of field strength, power density, or specific absorption rate (SAR), depending on the
RF source. The guidelines for evaluation of compliance with the Commission’s human exposure limits can be found in OET Bulletin 65.
1. Primacy of Specific Absorption Rate (SAR) over Power Density or Field Strength below 6 GHz
3. In the NPRM, the Commission proposed to allow evaluation based on specific absorption rate (SAR) in lieu of maximum permissible exposure (MPE) for fixed and mobile RF 3 sources below 6 GHz, since the MPE limits are derived from the SAR limits. Comments received were generally supportive.
4. Decision. The Commission amends its rules as proposed. (SAR evaluation continues to be required as the only acceptable compliance metric for portable devices below 6 GHz.) Entities can continue to use derived MPE evaluation methods for fixed and mobile RF sources where appropriate, as long as compliance with both the whole-body and localized SAR limits are ensured.
5. As SAR is the basic restriction developed to safeguard human health from the effects of RF emissions and MPE limits were derived from whole-body SAR, compliance with the SAR guidelines directly will provide ipso facto the protection specified in the Commission’s RF safety guidelines. However, for whole-body exposure at distances greater than 20 centimeters and below 6 GHz, the Commission continues to consider spatial-averaging techniques as sufficient to use along with MPE to demonstrate compliance with both localized and whole-body SAR limits in non-uniform fields in most cases.
6. In a compliance showing that uses SAR, the proponent must demonstrate that the device was evaluated in all applicable operating configurations and exposure conditions, considering both whole- and partial-body limits and both near- and far-field situations. The Commission will continue to allow MPE for demonstration of compliance with its limits under the conditions it has allowed in the past as a matter of choice SAR evaluation post factum where a violation of the MPE limits is found cannot be used to undermine enforceability of the MPE limits.
2. Technical Evaluation References in Rules
7. In the NPRM, the Commission proposed to discontinue the Office of Engineering and Technology (OET) Bulletin 65 Supplement C, an informational document which provides 4 guidance and general statements of its policies with regard to its RF exposure limits for portable and mobile devices, since OET is able to provide more up-to-date information for these devices in its Knowledge Database (KDB). The Commission also proposed to require that adequate documentation be provided with any application relying on computational modeling to demonstrated compliance showing that the test device and exposure conditions have been
correctly modeled.
8. Decision. The Commission amends the rules as proposed to reference the KDB in lieu of Supplement C to provide current guidance and policies on acceptable procedures for evaluating wireless devices. This will provide the Commission with the ability to promptly update this guidance as the work of expert bodies and other research indicate that changes are appropriate. Rulemaking procedures are not required by the Administrative Procedure Act for interpretative guidance and general statements of Commission policy.
See Administrative Procedure Act, 5 U.S.C. 553(b)(A). Exceptions to rulemaking include “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” The KDB falls within this scope.
9. The Commission fully intends to continue to use the KDB to provide guidance on techniques and methodologies recommended by internationally and domestically accepted expert standards bodies, such as the IEEE and the IEC, to the extent that their standard procedures ensure compliance with the Commission’s exposure limits. However, it is the responsibility of this Commission to ensure compliance with its exposure limits, and thus this agency will make the ultimate judgment as to whether it should include them.
By issuing the Commission’s own guidance on its policies, it can communicate how best to incorporate the input of all relevant
expert standards, readily use the most appropriate elements of conflicting outside standards, and also provide any additional information that may be helpful for evaluation. 5
10. The Commission also adopts its proposal to modify the language of § 2.1093(d)(3) to require that adequate documentation be provided in all cases relying on computational modeling. Parties are currently required to submit technical documentation supportive of the basis for compliance only upon request by the Commission, which would occur if there is information to
cast doubt on the assertion of compliance. In the case of computational modeling, however, a review of the technical bases for the modeling of the test device and exposure conditions is required in order for the Commission to make a determination of compliance before approval.
3. Pinna (Outer Ear) Classification as an Extremity
11. In the NPRM, the Commission requested comment on classifying the pinna (outer ear) as an extremity, to which less stringent exposure criteria would apply. Currently, the outer ear, or “pinna,” is not explicitly included on the list of exceptions from the localized SAR limits for “extremities” in the Commission’s rules. Nor has the Commission treated the pinna as subject to
the localized SAR limits applicable to the head or required parties seeking equipment authorizations to measure or calculate localized SAR in the pinna, as there is no standard for SAR measurement in the pinna. At the time of the NPRM IEEE Std 1528-2003 described the measurement procedure to be used for SAR measurement in the human head from cell phones.
It states in pertinent part that, “[t]he measurement of SAR induced in the external tissues of the head, e.g., the external ear (pinna), is not addressed in this standard.” It stated further that, “[t]his recommended practice does not address the measurement of SAR induced in the external tissues of the head, e.g., the external ear (pinna).” IEEE subsequently initiated deliberations to consider
classifying the pinna as an extremity.
12. Decision. The Commission received comments for and against this classification, and it amends § 1.1310 of its rules to subject the pinnae to the same RF exposure limit currently applicable to hands, wrists, feet, and ankles. The classification of the pinna
as an extremity is supported by the expert determinations of the FDA (which has the expertise and statutory responsibility to carry out a program designed to protect public health and safety 6 from electronic product radiation) and of the IEEE and will have no practical impact on the amount of human exposure to RF radiation, and is therefore appropriate.
4. Part 1 / Part 95 MedRadio (formerly Medical Implant Communications Service) Measurement Consistency 12. Section 1.1307(b)(2) requires initial SAR evaluation for medical devices within the Medical Device Radiocommunication Service (MedRadio Service) by either computation or measurement, but for MedRadio medical implant transmitters, § 95.1221 allows only computation for initial evaluation of these devices. In the NPRM, the Commission proposed to amend § 95.1221 to correct this inconsistency to allow either computation or measurement in both sections.
13. Decision. The Commission amends the rule as proposed. The inconsistency originated with the promulgation of § 95.603(f) and was perpetuated when the Commission relocated that section to another location in part 95, renumbering it as § 95.1221, as a result of the establishment of the new MedRadio Service.
b. Mitigation 14. Mitigation matters are post-evaluation procedures to ensure exposure limits are not exceeded, such as labels, signs, barriers, enforcement, and occupational issues. The Commission includes in this section clarifications related to the application of occupational exposure limits for devices and at fixed transmitter sites.
5. Labeling and Instructions for Mobile and Portable Devices Intended for Occupational Use Only 15. In the NPRM, the Commission proposed more specific labeling and instructional requirements for devices intended to be operated only in an occupational setting. 7 16. Decision. Comments received were generally supportive, and the Commission adopts its proposed changes in §§ 2.1091(d)(3) and 2.1093(d)(1) of its rules.
The Commission is adopting labeling requirements related to occupational/controlled exposure from mobile and portable devices, consistent with its proposals and the comments it received, by modifying §§ 2.1091(d)(3) and 2.1093(d)(1) to provide that labels may be used to satisfy the requirements for making workers aware of the potential for exposure under the conditions proposed in the NPRM.
In addition, the Commission will update OET Laboratory Division publications as necessary to provide more detailed guidance on complying with the requirements for labeling devices intended for occupational use. The Commission does not consider that label placement in the battery compartment helps ensure integrity and legibility of a label, nor is it clearly visible to the user. However, a “screen flash” option on power up is a more practical solution than external labeling, and so the Commission refers in general to either labels or a screen flash as “visual advisories” required in the final rules.
On the other hand, the Commission does not specify a format for visual advisories at this time but rather encourages development of labeling standards using similar symbols, colors, and signal words. With respect to requirements for coordination between equipment manufacturers and end users on training, the Commission is adopting language that coordination with end-user organizations is encouraged but not required. However, as discussed in the R&O training is required for persons subject to exposure in excess of the general population exposure limits.
6. Clarification of Application of Occupational Exposure Limits 17. The Commission’s occupation/controlled limits apply in part when individuals are “fully aware” of and can “exercise control” over their exposure. In the NPRM, the Commission proposed to state in its rules that appropriate information and training is necessary to achieve full awareness and control of exposure and to identify what would constitute appropriate information and training.
8 18. Decision. The Commission adopts its proposals with minor modification based on the comments received. The Commission specifies that for individuals exposed as a consequence of
their employment, using the occupational/controlled limits, written and/or verbal (orally communicated) information must be provided, at the discretion of the responsible party as is necessary to ensure compliance with the occupational/controlled limits. In addition, with the exception of transient individuals, appropriate training regarding work practices that will ensure that exposed persons are “fully aware of the potential for exposure and can exercise control over their exposure” is required to be provided. The Commission concludes that this two-tiered approach will provide sufficient information to ensure that people are adequately protected.
19. Regarding specific guidelines on what kind of information is required and what constitutes adequate training, the Commission will rely primarily on instructional and training resources already available. Section 1.1310 of the Commission’s rules already references OET Bulletin 65 as one resource, and it plans to update this bulletin after the conclusion of this docket to provide additional information regarding RF safety programs and available resources, including information now incorporated in the IEEE C95.7 recommended practice for RF safety programs referenced in the NPRM.
The Commission notes that training is not required for transient individuals, but they must receive written and/or verbal information and notification (for example, using signs) concerning their exposure potential and appropriate means available to
mitigate their exposure. The Commission further notes that the designation of “transient individual” applies to visitors and people traversing the site, not to third-party workers performing maintenance on the site for an extended period.
However, in the event of complaints that result in enforcement investigations, the Commission will evaluate, on a case-by-case basis, whether the information requirements are met, and if not whether the general population/uncontrolled exposure limits are appropriate to apply in a specific area where transient access is permitted. The Commission also adds language to remind licensees of their obligation to 9 consider worker as well as public exposure. Finally, the Commission codifies in its rules the extent to which occupation/controlled limits apply to amateur radio licensees.
7. Responsibility for Compliance at Fixed Sites with Multiple Transmitters 20. The Commission’s rules do not address apportionment of responsibility among licensees that exceed 5% of the exposure limits and are not categorically excluded. Comments received suggested that it is necessary for an individual licensee to be assigned primary responsibility for compliance at a multiple use site. However, the Commission clarifies that this is not the case and emphasize cooperation and that failure to comply at multiple use sites can result in penalties for all site occupants that contribute significantly to exposure, not just the newest occupant or the occupant which contributes the most to exposure.
21. Discussion. Given the variety of situations presented by multiple transmitter sites, responsibility for compliance and preparation of Environmental Assessments continues to apply multiple transmitter sites as described in § 1.1307(b)(3) of the Commission’s rules, and “significant” transmitters can be assumed to be based on the same threshold of 5% defined there.
The Commission notes that when routine evaluations are required at such sites, all relevant colocated licensees are responsible for compliance. Therefore, it is in the interest of these licensees to share information about power and other operating characteristics in order to achieve accurate representations of the RF environment. The Commission continues to encourage all site occupants, owners, leasers, and managers to cooperate in these endeavors, and notes that site user agreements are particularly useful and desirable to achieve this end.
As demonstrated in the record, all licensees that exceed five percent of the RF exposure limit at any non-compliant location are jointly and severally responsible, and the Commission may impose forfeiture liability on all such licensees.
10 c. Effective Date
22. Original Proposal. In the NPRM, the Commission recognized that licensees and applicants will need some period of time to become familiar with any changes to the Commission’s rules that could require additional routine evaluation for some previously excluded transmitters and devices and to modify their processes and procedures accordingly. Therefore, the Commission proposed in the NPRM to provide a transition period of six months after it adopts any new rules in this proceeding before they become effective.
The Commission now defers many of its decisions as proposals in the Further NPRM, and those adopted here are not as
extensive as those it originally proposed. The Commission expects that these rules can be readily complied with, and so it adopts an effective date of [60 days after date of publication in the Federal Register] for the final rules in this Order.
23. Decision. The Commission will not require a new evaluation of all existing sites that were excluded from evaluation under previous criteria. NEPA is a prospective statute. Moreover, even if NEPA or the Communications Act provided discretionary authority to require such existing sites to be evaluated under the Commission’s new rules, it would find that such
evaluation would not be necessary in this case.
The rule revisions set forth are generally procedural. The Commission is not adopting any changes to the exclusion criteria in the rules at time. In other words, if a site was “categorically excluded” or “exempt” from routine evaluation under the previous rules, it will still be exempt from routine evaluation under the rules the Commission adopts here. The Commission notes, however, that regardless of whether a site is exempt from routine evaluation, licensees are required to ensure that existing sites are in
compliance with the exposure limits. Furthermore, the Commission cautions that it may take enforcement action against licensees that do not comply with the exposure limits in the rules, regardless of whether their transmitters were “categorically excluded” or “exempt” from routine evaluation in the past. 11
24. The Commission’s final changes to its rules in this Order are relatively minor. However, the Commission recognizes that any such changes require a reasonable period of time to be implemented. Therefore, the Commission is setting an effective date of [60 days after date of publication in the Federal Register] for its final rules.
d. Deletion of Old Rules and Update of Portable and Mobile Service Evaluation List 25.
The Commission notes that an administrative change is necessary in the rules dealing with RF exposure. When the Commission last adopted major changes to these rules in 1996 and 1997, it also adopted certain “Transition Provisions.” These transition provisions, contained in § 1.1307(b)(4) and (5) of the Commission’s rules, no longer have any effect and are thus not
necessary. “All existing transmitting facilities, operations and devices” the Commission regulates were required to be in compliance with § 1.1307(b)(1) through (b)(3), by September 1, 2000 in accord with § 1.1307(b)(5). The Commission states in § 1.1307(b)(1) of its rules that its exposure limits “are generally applicable to all facilities, operations, and transmitters regulated by the
Commission.”
Thus, there are no facilities operating pursuant to the requirements in effect before the transition period that would become non-compliant with the rules as a result of the elimination of the transition period. Moreover, there are no pending enforcement cases where compliance with the transition deadline is at issue. The Commission is, therefore, sua sponte deleting these transition provisions from this rule part.
26. The Commission also notes that it is making necessary minor administrative changes for clarification and consistency between §§ 1.1307(b)(2), 2.1091(c), and 2.1093, which list services requiring routine RF evaluation for portable and mobile devices. Specifically, the Commission adds “Miscellaneous” to all three sections to correctly name the Miscellaneous Wireless Communications Service defined by part 27 of its rules; it adds “the 4.9 GHz Band Service” and “the Medical Device Radioc ommunication Service (MedRadio)” to § 1.1307(b)(2) 12 to reflect their inclusion in § 2.1093(c); and it adds “the 3650 MHz Wireless Broadband Service”to § 2.1091(c) and 2.1093(c), since this change was already adopted in the Report and Order in ET Docket 04-151, published in the Federal Register on May 11, 2005, but was never actually incorporated into the Code of Federal Regulations. These changes do not affect evaluation requirements for compliance or applicability of these sections to portable or mobile devices.
27. The regulatory changes discussed in the two preceding paragraphs do not require prior notice and opportunity for comment. Under the Administrative Procedure Act, notice and opportunity for comment are not required “when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor[e] in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.”
Here, the Commission for good cause finds that notice and comment are unnecessary for eliminating 47 CFR 1.1307(b)(4) and (5), because these rules have outlived their purpose and no longer serve any function. Similarly, the Commission for good cause finds that notice and comment are unnecessary for amending 47 CFR 1.1307(b)(2), 2.1091(c), and 2.1093.
Final Regulatory Flexibility Analysis 28. As required by the Regulatory Flexibility Act (RFA),1an Initial Regulatory Flexibility Analysis was incorporated in the Notice of Proposed Rulemaking (NPRM) in ET Docket 03-137.2
The Commission sought written public comment on the proposals in the NPRM, including comment on the IRFA.3 This Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.
