The following has been excerpted from an FDA-published document, Sunlamp Products Performance Standard, and is presented as general information for the suntanning device owner or operator:
The Sunlamp Product Performance Standard, 21 CFR 1040.20, applies to (1) any sunlamp product “designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 180 and 320 nanometers, to induce skin tanning,” and (2) any ultraviolet lamp “which produces radiation in the wavelength interval of 180 to 320 nanometers in air and is intended for use in any sunlamp product.” The standard requires the elimination of unnecessary UVC radiation (180 through 260 nanometers) from sunlamp products, that sunlamp products have a timer that limits the duration of UV emission to ten minutes or less with manual recycling provisions, and that protective eyewear be provided with sunlamp products. The hazards due to chronic exposure to UVB radiation, and the use of photosensitizers that interact primarily with UVA radiation are addressed in the form of warning labels on sunlamp products and user information accompanying the product. The conventional RS (reflector spot) sunlamp, the bi-pin fluorescent type sunlamp and the bare quartz sunlamp, examples of the products for which the sunlamp standard originally was developed, emit a relatively high percentage of UVB radiation (8 percent to 58 percent). Sunlamp product manufacturers recently have developed sunlamps for which the ratio of UVA to UVB emissions have been adjusted so that only a relatively small quantity of UVB (two percent or less) is emitted compared to the much higher quantity of UVA radiation and there is no measurable UVC radiation below 260 nanometers. These sunlamps require a much longer exposure to cause erythema and/or tanning and the acute hazard of severe sunburn appears to be reduced greatly. Consequently, the question has been raised concerning which sunlamp products are subject to the Sunlamp Product Performance Standard, 21 CFR 1040.20.
The position of the Bureau of Radiological Health is that the performance standard (21 CFR 1040.20) applies to all sunlamp products (including UVA sunlamp products) or ultraviolet lamps intended for skin tanning which emit ultraviolet radiation with wavelengths in air between 180 and 320 nanometers.
Recommended initial exposure intervals for skin tanning products that emit 2 percent or less of UVB radiation are often in excess of one-half hour duration. Since these lengthy exposure intervals do not appear to pose severe erythema problems, the bureau will be amendable to variance requests for an extension of the maximum timer interval (21 CFR 1040.20(c)(20) and modification of the wording of warning labels (21 CFR 1040.20(d) to achieve the same degree of safety and freedom from hazard intended by the standard. Also, the Bureau will consider amendments to the sunlamp standard to eliminate the need for variances for sunlamp products that emit a low percentage of UVB radiation. Since sunlamp products which emit 2 percent or less of UVB radiation were not considered in formulating the standard and variances from certain requirements may be appropriate, the Bureau of Radiological Health will not take enforcement action against such products for failure to comply if manufactured prior to Oct. 7, 1980. This will allow adequate time for these products to be designed and manufactured in compliance with the standard and for variance applications to be submitted and acted on. However, this policy will not apply to conventional UVB sunlamp products, e.g., the RS sunlamp, bi-pin fluorescent type sunlamp and the quartz sunlamp.
Manufacturers should note that sunlamp products, which emit only UVA radiation and, thus, are not subject to the performance standard for sunlamp products, are still subject to the FDA requirements applicable to medical devices (under the Medical Device Amendments of 1976) and to the defect provisions of the Radiation Control for Health and Safety Act of 1968 (21 CFR 1003). The equipment recommendations for tanning booths issued by the Bureau of Radiological Health on Nov. 16, 1979, should be considered in any design or testing program for these products. While such items as the 10 minute limit for the timer may not be appropriate, the maximum timer error of + or - 10 percent is still important as is the wearing of appropriate UVA protective eyewear by users.
Possible Amendments
On Feb. 10, 1999 the FDA announced its intent to propose amendments to the performance standard for sunlamp products.
The FDA is taking this action to address concerns about the adequacy of the warnings on sunlamp products, current recommended exposure schedule to minimize risks to customers who choose to produce and maintain a tan, current labeling for replacement lamps and current health warnings that do not reflect recent advances in photobiological research.
The Safe Medical Devices Act of 1990, enacted Nov. 28, 1990, transferred the provisions of the Radiation Control for Health Service Act to Chapter V, subchapter C of the Federal Food, Drug and Cosmetic Act. This authority provides for developing, amending and administering radiation safety performance standards for electronic products.
Sunlamp products are Class I medical devices exempt from pre-market modification requirements. These products are intended to provide ultraviolet radiation to tan the skin. As class I devices, sunlamp products are subject to general controls such as registration, listing and current good manufacturing practices. In addition, sunlamp products also are subject to the regulations for electronic product radiation control.
The sunlamp performance standard originally was published in the Federal Register on Nov. 9, 1979. On Sept. 6, 1985, the FDA amended Sec. 1040.20 and made it applicable to all sunlamp products manufactured on or after Sept. 8, 1986. On Aug. 21, 1986, the FDA issued a guidance titled, “Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.” The guidance explained the criteria the FDA uses to evaluate the adequacy of the exposure schedule and the recommended maximum exposure time for sunlamp products. On Sept. 2, 1986, the FDA issued another guidance entitled, “Policy on Lamp Compatibility.” The guidance listed the criteria the FDA uses to evaluate lamp compatibility for sunlamp products.
Before proposing any electronic product performance standards, the FDA is required to consult a statutory advisory committee, the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). At the Sept. 23-24, 1998 meeting of TEPRSSC, the FDA presented general concepts for amendments to the performance standard for sunlamp products. The committee recommended the FDA pursue development of the amendments and the FDA intends to present more specific proposals to amend the performance standard to TEPRSSC prior to the publication of the proposed rule in the Federal Register.
The FDA is concerned that inadequate attention is being paid to the recommended exposure schedule that was designed to minimize risks for those who choose to produce and maintain a tan. In addition, the FDA is further concerned that the warnings for sunlamp products are not reaching many users of sunlamp products and that the existing exposure schedule does not take into account the variations in individual human UV sensitivity. In order to update the current sunlamp products standards, the FDA is considering revising Sec. 1040.20.
Additionally, sunlamp technology continues to change. These changes can affect both the intensity and the spectral characteristics of UV from sunlamps. Because there is no uniform grading/rating system, choosing a replacement lamp can be confusing for tanning bed owners. Owners choosing replacement lamps must consider lamp compatibility as well as compliance with the FDA’s performance standard in order to protect users from excessive exposure to UV.
The FDA also is aware of new research findings that suggest a stronger association between exposures to UV radiation and the increased incidence of skin cancer that has been observed in the U.S. population. Some of this increase has been linked to intense, intermittent exposures to solar radiation; however, other research suggests that chronic, less intense exposures to UV radiation contribute to skin cancer.
Research has identified the fundamental chemical damage that occurs in the genetic material of humans and has linked some skin cancers to changes in specific genes. These scientific findings had led many in the medical community to strongly suggest that consumers avoid intense, intermittent exposures (the type that could produce sunburns) to UV radiation, and also minimize other UV exposures as well.
Some research has linked skin cancer to exposures to sunlamp products, and some research has even suggested an association between the use of sunlamps and malignant melanoma. This association is not definitive. The FDA solicits comments and information as to whether a warning about possible melanoma induction should be part of sunlamp labels. In order to provide users with sufficient information for the safe use of these devices at tanning salons and for home sunlamp products, the FDA is seeking comments and information on suggested changes to the current sunlamp labels.
After considering the risks, some consumers may still choose to tan, either by exposure to the sun or by use of sunlamp products. Those consumers who use sunlamp products should obtain their tan with the least amount of risk from sunburn and eye damage. Therefore, the FDA seeks advice on a recommended exposure schedule that would minimize the risks of adverse effects while still producing and maintaining a tan.
Revisions Under Consideration
The FDA is considering revising and updating the current sunlamp product performance standard (Sec. 1040.20) and harmonizing it with the International Electrotechnical Committee Standard 335-2-27 for UV- and infrared-emitting appliances. After consulting with international standards organizations and evaluation of the current scientific knowledge, the FDA intends to develop a recommended exposure schedule that will become part of the directions for use of sunlamp products.
As part of the development process, the FDA intends to review the material on the effects of UVA and UVB on skin, the effects of UV exposure on melanoma induction and the use of photobiological action spectra as a basis for risk assessment in health protection and product safety discussed at the American Society for Photobiology and European Society for Photobiology Joint Workshop on UV and Melanoma held in Snowbird, Utah, July 11-15, 1998; the International Symposium and Workshop on Measurements of Optical Radiation Hazards, at the National Institute for Standards and Technology held in Gaithersburg, Md., Sept. 1-3, 1998; and, the Research Workshop on Risks and Benefits of Exposure to Ultraviolet Radiation and Tanning, at the National Institutes of Health in Bethesda, Md., Sept. 16-18, 1998. The proceedings of these meetings describe current research findings that show a stronger correlation between UV exposure and skin cancer, photoaging and photoimmunological effects.
The FDA also is considering revising and updating its Aug. 21, 1986, guidance on the determination of the maximum timer interval and recommended exposure schedule for sunlamp products entitled, “Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.” The FDA intends to update this guidance after reviewing and evaluating material presented at the meetings listed previously and other available information. In addition, the FDA is further considering incorporating the previous guidance into the sunlamp product performance standard because it believes such incorporation would result in a more comprehensive regulatory standard with all relevant information for compliance in the standard.
Additionally, the FDA is considering adding a provision clarifying that manufacturing includes the modification of a sunlamp product, previously certified under Sec. 1010.2, by any person engaged in the business of manufacturing, assembling or modifying a sunlamp product’s performance, information or intended function for which Sec. 1040.20 has an applicable requirement. This addition would clarify that sunlamp products are being regulated like other products regulated under Sec. 1010.2. The FDA also is considering requiring the manufacturer who performs such modification to recertify and re-identify the product in accordance with the provisions of Secs. 1010.2 and 1010.3. This potential amendment is intended to clarify the responsibilities of firms and individuals who are in the business of installing UV lamps and new timers with different performance characteristics than the original lamps and timers in previously certified products.
The FDA also is considering requiring the reproduction of the text of the warning statement specified in Sec. 1040.20 (d) (1) (i) in catalogs, specification sheets and brochures pertaining to sunlamp products. The FDA is concerned that consumers who purchase sunlamp products through catalog mail order or through catalogs on electronic media may not receive information about the associated hazards and risks until the products are delivered to their homes and unpacked.
Finally, to simplify appropriate lamp replacement, the FDA is considering the development of a biological efficacy rating scale for UV lamps intended for use in sunlamp products. Lamp technology continues to evolve, affecting the levels of UV exposure, the spectral characteristics and, therefore, the biological efficacy of ultraviolet lamp radiation. Presently, a label that specifies the type of lamps suitable for replacement in the product is required on sunlamp products and in the user instructions. As new lamps and new lamp manufacturers enter the marketplace, it is increasingly cumbersome to keep track of individual lamp designations that are compatible with the product and compliant with the standard. In order to simplify the process, especially for industry and state regulators, the FDA is considering a uniform grading/rating system.
Comments to the ANPRM were received in July 1999 and have been under review since then. In September 1999, W. Howard Cyr, Ph.D., director of the Center of Devices and Radiation Health, updated the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) on the status of the ANPRM and the CDRH’s recommendations based on the comments received by the deadline.
Since then several meetings have occurred to discuss possible amendments. The most recent meeting was held in October 2003 where FDA proposed, and TEPRSSC approved, the adoption of the X/Y Ratio system. Although FDA was given the green light to develop amendments to the U.S. performance standard for sunlamp products, to date they have not done so.
Recently, FDA announced their intention to revise the warning label affixed to tanning devices and to adopt the European Union 0.3 W/m^2 maximum irradiance standard.
However, before final acceptance of any changes, FDA must submit a proposal for final acceptance. The public comment period has not yet been established.
