U.S. Divisions Regulating Nonionizing Radiation

The key U.S. government agencies involved in regulating NIR are listed in Table 1. U.S. regulatory guidance specifically addresses some kinds of NIR sources in some spectral regions while omitting direct mention of other sources and spectral regions. For example, Curtis acknowledges that the exposure standards in the OSHA are dated, noting the following weaknesses: the construction industry standard does not include laser classification and controls; the radio frequency exposure limit is from the 1966 ANSI standard (it has no frequency dependence and does not address induced current limits); The RF Safety Program Elements are incomplete. However, the obligation of employers under the General Duty Clause of OSHA to protect workers from recognized hazards compels the control of all potentially harmful NIR hazards(sales lead sheet), whether specifically regulated or not.

Various government agencies also provide a wealth of guidance beyond the requirements specified in the regulations. As noted in Table 1, the FDA regulations apply primarily to manufacturers, so although much FDA guidance clearly pertains to the end users, the FDA typically does not inspect healthcare providers or enforce compliance with FDA guidance by healthcare facilities. However, other organizations that do routinely audit healthcare providers, including in particular the JCAHO, refer to and hold hospitals accountable for compliance with FDA guidance.

Table 2 summarizes the requirements of those states having comprehensive laser safety regulations, adapted and updated from Ref. Many of these states have also passed regulations for the control of other NIR hazards as well. Several nonregulatory organizations have established exposure limits covering the entire NIR spectrum(portable ultrasound machine). The primary industry consensus standard organizations and international standard-setting agencies appear in Table 3. Some of these voluntary standards carry more weight than others, especially internationally. For example, all member countries of the European Union are required to adopt the laser safety standard, IEC/EN 60825-1, of the International Electrotechnical Commission (IEC), which has also been adopted by Japan, Australia, Canada, and nearly every other nation that publishes a laser standard. In addition, the FDA now accepts conformance with the IEC/EN 60825- 1 in lieu of conformance with most (but not all) of the requirements of the U.S. Federal Laser Product Performance Standard. Similarly, the FDA, OSHA, and JCAHO all reference the ANSI Z136 series of standards.