FDA Amendment 21 CFR Part 1040 Effective Sept. 1986

The current 10-minute maximum timer interval and the requirement concerning resumption of radiation emission, however, are inappropriate for newer sunlamp products now on the market. The agency’s position on these two requirements remains as expressed in the discussion in the preamble to the proposed rule (48 FR 22888).

FDA notes that the timer is defined in 1040.20(b)(10) as any device incorporated into a sunlamp product that terminates radiation emission after a preset time interval. A sunlamp product may, however, be designed to use more than one source of ultraviolet radiation with differing spectral distributions. Such a product may need to incorporate more than one timer and more than one maximum exposure time to minimize potential injury to the user. The manufacturer is required to provide a recommended exposure schedule that would not result in acute injuries when followed and to provide the means to enable the user to follow these instructions regardless of the complexity of the spectral distribution of the radiation. The standard is modified in the final rule to make this requirement clear.

4. A comment stated that the language of 1040.20 (c)(2)(iv) of the proposed amendments may be misleading because the proposed language may be interpreted to exclude timers that automatically will resume radiation at the point when power is interrupted. Because the intent of the amendment has been perceived to allow this usage, the comment suggested that this requirement be revised to state, "The timer may not automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle, when emission from the sunlamp product has been terminated."

The agency accepts the suggested change.

5.A comment suggested that the warning statement required by 1040.20(d)(1)(i) should utilize the signal word "CAUTION" rather than "DANGER." The comment contended that the word "DANGER" implies an immediate and serious threat to life, a hazard not associated with UVA sunlamp products, i.e., sunlamp products that operate in the wavelength region of 320 nm to 400 nm. The comment stated that there is a need for an appropriate warning label cautioning the user that certain safeguards need to be observed to avoid injury and that prolonged use has long-term risk.

The agency believes that the word "DANGER" as used on the warning statement is appropriate. Exposure to ultraviolet radiation can be an immediate threat to life for people using photosensitizing medications or cosmetics and for people with a medical condition that causes them to be sensitive to ultraviolet radiation, for example, photoallergies.