FDA Amendment 21 CFR Part 1040

FDA Amendment 21 CFR Part 1040
Effective Sept. 1986

Agency: Food and Drug Administration.
Action: Final rule.

Summary: The Food and Drug Administration is amending the performance standard for sunlamp products and ultraviolet (UV) lamps intended for use in these products to accommodate new products employing design concepts significantly different from those for which the current standard was developed. Also, FDA’s experience in applying the current standard, which went into effect on May 7, 1980, indicates that some requirements are either inappropriate or inapplicable to some products. The amendments are intended to establish a standard that is appropriate for the present technology of suntanning and new sunlamp product designs.

Dates: Effective Sept. 8, 1986, for sunlamp products and ultraviolet lamps that are manufactured on or after this date. For additional information concerning the applicability of this amended performance standard, see the “EFFECTIVE DATE” paragraph in the preamble of this document. The Director of the Office of the Federal Register approves the incorporation by reference of certain publications in 21 CFR 1040.20 effective Sept. 8, 1986.

For Further Information Contact: Manuel Karos, FDA Office of Compliance, 2098 Gaither Road, Rockville, MD 20850, (301) 594-4654, ext. 149.

In the Federal Register of May 20, 1983 (48 FR 22886) (corrected Oct. 21, 1983; 48 FR 48837), FDA issued a proposed rule to amend the performance standard for sunlamp products and ultraviolet lamps intended for use in sunlamp products (21 CFR 1040.20). In the preamble to the May 20, 1983, proposal, FDA discussed the history of 1040.20 and the issues that led to the agency’s decision to propose to revise the standard. The preamble also described the changes in the standard that FDA proposed to make based on the agency’s experience in administering the standard. Interested persons were given until July 19, 1983, to provide written data, views or comments concerning the amendments and any associated information on their potential environmental or economic impact.

Comments were received from an interested member of the public, a medical academy, two manufacturers, an individual who described himself as an association representing suntanning professionals, and a Canadian government agency. A summary of the comments and FDA’s responses to them follows:

1.One comment agreed with the proposed amendments as they would apply to the use of sunlamp products for skin-tanning purposes but questioned whether the regulations also were intended to apply to sunlamp products used for medical purposes. The comment stated that most of the safety provisions of the proposed rule should be adhered to regardless of the purpose of the sunlamp use. The comment suggested, however, that the warning statement in 1040.20(d)(1)(i) not be required to be included on medical therapy units because the statement would establish a negative environment for the treatment regimen and would be counterproductive. In addition, the warning statement could cause patients to resist the use of an effective form of therapy for diseases such as psoriasis. Section 1840.20 applies only to sunlamp products as defined in 1040.20(b)(9): “Sunlamp product means any electronic product designed to incorporate one or more ultraviolet lamps intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths between 200 nm and 400 nm, to induce skin tanning” (emphasis added). Accordingly, the warning statement of 1040.20 (d)(1)(i) applies only to sunlamp products intended for skin tanning.

2. One comment suggested that the proposed amendments should be modeled after the draft German Industrial Standard DIN 50-50, “Non-Therapeutical UV Irradiation Apparatus for the Human Body.” In this standard, a sunburn effect is defined by the erythema-threshold time and by the tanning effect (pigmentation-threshold time). Each manufacturer is required to declare on its sunlamp product label the erythema and pigmentation threshold times for the product. In addition, the product is required to be classified and labeled according to the magnitude of the erythema-threshold time.

FDA believes that the current standard, which requires manufacturers to provide adequate directions for use, including recommended exposure schedules and exposure positions, achieves the same goals that the German standard achieves. FDA’s Evaluation indicates that little safety advantage is to be gained by rating sunlamp products according to an estimated erythema potential. To establish a system of erythema potential ratings that would be appropriate under all use conditions and for all product designs or configurations would be burdensome and excessively complicated. A sunlamp product may have almost any spectral distribution and irradiance depending upon varying factors; for example, product design, lamp design and lamp age. Also, human skin varies greatly from individual to individual in sensitivity to burning induced by sunlamp products. For all these reasons, FDA declines to adopt the suggestion.

3.One comment on 1040.20(c)(2)(ii) objected to FDA’s proposal to remove the current 10-minute limit on a sunlamp product timer. The comment also objected to the proposal to revise 1040.20(c)(4) to proscribe only automatic resumption of emission from a product. The comment argued that such changes inappropriately allow the manufacturer, seller, or user of the product to decide what conditions of sunlamp use are safe.

FDA believes that irradiation of the skin with ultraviolet radiation to induce skin tanning is hazardous. The performance standard for sunlamp products was established to protect the consumer from acute burns (as evidenced by erythema) and from exposure to hazardous radiation that is unnecessary for skin tanning (in this case, UV radiation of wavelengths in air of less than 280 nm and to warn the consumer of the known adverse effects to the body after exposure to ultraviolet radiation. FDA believes that the user of a sunlamp product can take appropriate action when informed of the possible adverse effects to the body from exposure to ultraviolet radiation, if the product is equipped with necessary safety performance features.

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.

6.One comment urged that UVA lamps should be exempt from the provisions of 1040.20(d) that require the warning: “As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer.” The comment argued that radiation at wavelengths in air longer than 320 nm cannot induce skin cancer and that only radiation at wavelengths in air shorter than 320 nm is responsible for premature skin aging. The comment argued further that UVA radiation that does not contain measurable UVB radiation (280 nm to 320 nm) has positive effects, for example, a UVA tan can protect a person against the harmful UVB radiation of the sun (photoprotection), and UVA radiation that does not contain UVB radiation can monomerize pyrimidine dimers in the deoxyribonucleic acid (DNA).

FDA disagrees that it has been proven that UVA does not cause skin cancer or premature skin aging, or that UVA radiation can protect humans against UVB radiation. Relatively few studies have been carried out on the long-term biological effects of UVA radiation in humans or in animals. Further studies are needed to establish clearly the long-term biological effects of UVA radiation. There are, however, reports that, under long-term continuous exposure, UVA radiation can induce skin cancer in test animals (Refs. 1 and 2). Also, there is evidence that the incidence of skin tumors induced in animals by irradiation with a combination of UVB and UVA radiation can be increased by subsequent irradiation with UVA alone (Ref. 3).

There is evidence (Ref. 4) that UVA radiation can enhance the photoreactivation of pyrimidine dimers in the DNA of human leukocytes. However, this effect has not been shown to provide humans protection against UVB radiation (Ref. 5). The Task Force on photobiology of the American Academy of Dermatology has expressed concerns about potential risks of tanning with UVA radiation (Ref. 8).

Based on available evidence, FDA concludes that to exempt UVA lamps from the warning statement required by the standard would not promote the public health and safety.

7.One comment disagreed with the language of the warning statement set forth in 1040.20(d)(1) of the proposed amendments and argued that the statement, “If you do not tan in the sun, you are unlikely to tan from the use of this product,” would be inappropriate because it may confuse the sunlamp user. The comment argued that the action of direct exposure to the sun cannot be compared to that of exposure to either UVA or UVB suntanning equipment: that the current warnings already clearly and accurately provide the same information in more detail; and that the quoted statement would be redundant to the statement “Consult a physician before using lamp if taking any medication or if you believe yourself sensitive to sunlight.”

The agency disagrees with the comment. The scientific literature clearly demonstrates that some people do not tan or that they tan only with great difficulty using either the sun or sunlamps (Ref. 7). People who, when exposed to the sun, do not tan or tan only with great difficulty should be informed about the futility of exposures to potentially hazardous ultraviolet radiation.

8.A comment disagreed with the requirements of 1040.20(d)(l)(vi) and (2) of the proposed amendments, arguing that there are not any lamps that are “uniquely designed” for a particular sunlamp product. According to the comment, only a few manufacturers of lamps manufacture replacement lamps for other manufacturers’ sunlamp products. The comment stated that FDA is providing an unfair competitive advantage to certain manufacturers and a great disadvantage to others because the additional labeling would be extremely expensive, in monetary as well as person-hour terms. The comment said that the requirement would have a significant impact on a substantial number of small entities, as this term is used in the Regulatory Flexibility Act. The comment stated further that it would be impossible for some manufacturers to maintain and service their own products because their products are distributed throughout the country and urged the agency not to exempt any sunlamp products or ultraviolet lamps from the proposed labeling requirements. According to the comment, there would be no way for FDA to monitor whether a particular unit was being maintained and serviced by the manufacturer or its agent.

After having reviewed reports submitted to the agency under Part 1002 (21 CFR Part 1002), FDA agrees that there are few ultraviolet lamps that are unique to a sunlamp product. The agency concludes that a substitute lamp could be made by other manufacturers. Also, FDA agrees that monitoring the maintenance and servicing of sunlamp products would be difficult and would not be warranted. For these reasons, FDA has concluded not to exempt any sunlamp products or ultraviolet lamps from the labeling requirements and has revised final 1040.20(d) (l)(vi) and (2) accordingly.

The comment does, however, illustrate that manufacturers use lamps produced by other firms. It also is apparent that many of these lamps are equivalent and can be used safely in a number of different models of sunlamp products. The current standard is not clear on how a person or manufacturer would be able to determine that a replacement lamp is equivalent to that designated on the sunlamp product to be used in the product. FDA advises that replacement lamps must comply with each applicable requirement of the performance standard and be certified under 1010.2 of the regulations (21 CFR 1010.2). Section 1040.20(e) requires that any ultraviolet lamp not accompanying a sunlamp product contain instructions for its safe use. Thus, the manufacturer of a replacement ultraviolet lamp is required to state in the user instructions any specific model of ultraviolet lamps for which the manufacturer is promoting its lamp as a replacement. FDA has revised 1040.20(e)(2) in the final rule to make this concept clear. FDA advises that the promotion of incompatible lamps will be considered as marketing a falsely certified product.

The final rule became effective Sept. 8, 1986, for sunlamp products and ultraviolet lamps that are manufactured on or after this date. Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980, but before Sept. 8, 1986, are subject to the provisions of 21 CFR 1040.20 as published in the Federal Register of Nov. 9, 1979 (44 FR 65357). The agency, however, does not object to any manufacturer of a sunlamp product or ultraviolet lamp complying with the final rule after it is published and prior to its effective date, provided the manufacturer specifies on the certification label for the product that it complies with the amended standard and provided the manufacturer complies with the recordkeeping and reporting requirements of Part 1002.

The following references are on file in the Dockets Management Branch (HFA305), Food and Drug Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Forbes, P.D., R.E. Davies, and C.A. Cole, “Photocarcinogenesis by UVA Alone,” Abstract MAM-D6, Tenth Annual Meeting, American Society for Photobiology, Vancouver, BC, Canada. June 27-July 1, 1982.

2. Van Weelden, H., F.R. de Gruijl, and J.C. van der Leun, “Tumors induced by UVA in Mice,” Abstract WAM-F4, Photochemistry and Photobiology, 7S:79, 1983.

3. Staberg B. et al. “The Carcinogenic Effect of UVA Irradiation,” Journal of Investigative Dermatology, 81:6:517-519, 1983.

4. Sutherland. B.M., P. Runge, and J.C. Sutherland, “DNA Photoreactivating Enzyme from Placental Mammals. Origin and Characteristics,” Biochemistry 23:4710-4715, 1974.

5. Mutzhas. M.F., et al., “A New Apparatus with High Radiation Between 328-480 nm: Physical Description and Dermatological Applications.” Journal of Investigative Dermatology, 76:42-47, 1981.

6. Jeffry, Jr., T.E., “Danger of Tanning Booths Bared. New Release,” American Academy of Dermatology. Evanston, IL, May 1, 1983.

7. Pathak, M.A., “Sunscreens: Topical and Systemic Approaches for Protection of Human Skin Against Harmful Effects of Solar Radiation.” Journal of the American Academy of Dermatology, 7:285-311, 1982.

The FDA has evaluated the economic consequences of this action in accordance with Executive Order 12291 and the Regulatory Flexibility Act (Pub. L. 98-354). This action has been determined not to be a major rule as defined in Executive Order 12291. Further, the agency certifies that the final rule will not have a significant impact on a substantial number of small entities, as defined in the Regulatory Flexibility Act. A threshold assessment supporting this conclusion is on file with the Dockets Management Branch (address above).

Section 1040.20 (d) and (e) of this final rule contains information collection requirements that were submitted for review and approval to the Director of the Office of Management and Budget (OMB), as required by Section 3507 of the Paperwork Reduction Act of 1980. The requirements were approved and assigned OMB control number 09100195.

Electronic products, HID lamps, Incorporation by reference, Lasers, Medical devices, Radiation protection, Standards, Sunlamps. Therefore, under the Public Health Service Act, as amended by the Radiation Control for Health and Safety Act of 1968. Part 1040 is amended to read as follows:

PART 1040—PERFORMANCE STANDARDS FOR LIGHTEMITTING PRODUCTS

1. The authority citation for Part 1040 continues to read as follows: Authority: Secs. 358, 360A, 82 Stat. 11771179, 1182 (42 U.S.C. 263f, 263i); 21 CFR 5.10.

2. By revising 1040.20. to read as follows:
§1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a)Applicability.

(1) The provisions of this section, as amended, are applicable as specified herein to the following products manufactured on or after Sept. 8, 1986.

(i) Any sunlamp product.

(ii) Any ultraviolet lamp intended for use in any sunlamp product.

(2) Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980, but before Sept. 8, 1986, are subject to the provisions of this section as published in the FEDERAL REGISTER of Nov. 9, 1979 (44 FR 65357).

(b) Definitions. As used in this section the following definitions apply:

(1) “Exposure position” means any position, distance, orientation, or location relative to the radiating surfaces of the sunlamp product at which the user is intended to be exposed to ultraviolet radiation from the product, as recommended by the manufacturer.

(2) “Intended” means the same as “intended uses” in 801.4.

(3) “Irradiance” means the radiant power incident on a surface at a specified location and orientation relative to the radiating surface divided by the area of the surface, as the area becomes vanishingly small, expressed in units of watts per square centimeter (W/cm2).

(4) “Maximum exposure time” means the greatest continuous exposure time interval recommended by the manufacturer of the product.

(5) “Maximum timer interval” means the greatest time interval setting on the timer of a product.

(6) “Protective eyewear” means any device designed to be worn by users of a product to reduce exposure of the eyes to radiation emitted by the product.

(7) “Spectral irradiance” means the irradiance resulting from radiation within a wavelength range divided by the wavelength range as the range becomes vanishingly small, expressed in units of watts per square centimeter per nanometer (W/(cm/nm).

(8) “Spectral transmittance” means the spectral irradiance transmitted through protective eyewear divided by the spectral irradiance incident on the protective eyewear.

(9) “Sunlamp product” means any electronic 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 200 nm and 400 nm, to induce skin tanning.

(10) “Timer” means any device incorporated into a product that terminates radiation emission after a pre-set time interval.

(11) “Ultraviolet lamp” means any lamp that produces ultraviolet radiation in the wavelength interval of 200 nm to 400 nm in air and that is intended for use in any sunlamp product.

(c) Performance requirements

(1) Irradiance ratio limits. For each sunlamp product and ult raviolet lamp, the ratio of the irradiance within the wavelength range of greater than 200 nm through 260 nm to the irr adiance within the wavelength range of greater than 260 nm th rough 320 nm may not exceed 0.003 at any distance and direct ion from the product or lamp.

(2) Timer system.

(i) Each sunlamp product shall incorporate a timer system with multiple timer settings adequate for the recommended exposure time intervals for different exposure positions and expected results of the products as specified in the label required by paragraph (d) of this section.

(ii) The maximum timer interval(s) may not exceed the manufacturer’s recommended maximum exposure time(s) that is indicated on the label required by paragraph (d)(l)(iv) of this section.

(iii) No timer interval may have an error greater than 10 percent of the maximum timer interval of the product.

(iv) 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.

(v) The timer requirements do not preclude a product from allowing a user to reset the timer before the end of the preset time interval.

(3) Control for termination of radiation emission. Each sunlamp product shall incorporate a control on the product to enable the person being exposed to terminate manually/radiation emission from the product at any time without disconnecting the electrical plug or removing the ultraviolet lamp.

(4) Protective eyewear.

(i) Each sunlamp product shall be accompanied by the number of sets of protective eyewear that is equal to the maximum number of persons that the instructions provided under paragraph (e)(1)(ii) of this section recommend to be exposed simultaneously to radiation from such product.

(ii) The spectral transmittance to the eye of the protective eyewear required by paragraph (c)(4)(i) of this section shall not exceed a value of 0.001 over the wavelength range of greater than 200 nm 320 nm and a value of 0.01 over the wavelength range of greater than 320 nm through 400 nm, and shall be sufficient over the wavelength greater than 400 nm to enable the user to see clearly enough to reset the timer.

(5) Compatibility of lamps. An ultraviolet lamp may not be capable of insertion and operation in either the “single-contact medium screw” or the “double-contact medium screw” lampholders described in American National Standard C81.10-1976, Specifications for Electric Lamp Bases and Holders—Screw-Shell Types, which is incorporated by reference. Copies are available from the American National Standards Institute, 1430 Broadway, New York, NY 10018, or available for inspection at the Office of the Federal Register, 1100 L St. NW., Washington, D.C. 20408.

(d) Label requirements. In addition to the labeling requirements in Part 801 and the certification and identification requirements of 1010.2 and 1010.3, each sunlamp product and ultraviolet lamp shall be subject to the labeling requirements prescribed in this paragraph and paragraph (e) of this section.

(1) Labels for sunlamp products. Each sunlamp product shall have a label(s) which contains:

(i) A warning statement with the words “DANGER—Ultraviolet radiation. Follow instructions. Avoid overexposure. As with natural sunlight, over exposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR: FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight. If you do not tan in the sun, you are unlikely to tan from the use of this product.”

(ii) Recommended exposure position(s). Any exposure position may be expressed either in terms of a distance specified both in meters and feet (or in inches) or through the use of markings or other means to indicate clearly the recommended exposure position.

(iii) Directions for achieving the recommended exposure position(s) and a warning that the use of other positions may result in overexposure.

(iv) A recommended exposure schedule including duration and spacing of sequential exposures and maximum exposure time(s) in minutes.

(v) A statement of the time it may take before the expected results appear.

(vi) Designation of the ultraviolet lamp type to be used in the product.

(2) Labels for ultraviolet lamps. Each ultraviolet lamp shall have a label which contains:

(i) The words “Sunlamp—DANGER—Ultraviolet radiation. Follow instructions.”

(ii) The model identification.

(iii) The words “Use ONLY in fixture equipped with a timer.”

(3) Label specifications.

(i) Any label prescribed in this paragraph for sunlamp products shall be permanently affixed or inscribed on an exterior surface of the product when fully assembled for use so as to be legible and readily accessible to view by the person being exposed immediately before the use of the product.

(ii) Any label prescribed in this paragraph for ultraviolet lamps shall be permanently affixed or inscribed on the product so as to be legible and readily accessible to view.

(iii) If the size, configuration, design or function of the sunlamp product or ultraviolet lamp would preclude compliance with the requirements for any required label or would render the required wording of such label inappropriate or ineffective, or would render the required label unnecessary, the Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health, on the Center’s own initiative or upon written application by the manufacturer, may approve alternate means of providing such label(s), alternate wording for such label(s), or deletion, as applicable.

(iv) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by 1010.2(b) and 1010.3(a), the manufacturer of the ultraviolet lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the lamp, if the name of the manufacturer and month and year of manufacture are permanently affixed or inscribed on the exterior surface of the ultraviolet lamp so as to be legible and readily accessible to view. The name of the manufacturer and month and year of manufacture affixed or inscribed on the exterior surface of the lamp may be expressed in code or symbols, if the manufacturer has previously supplied the Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health, with the key to such code or symbols and the location of the coded information or symbols on the ultraviolet lamp. The label or tag affixed or inscribed on the lamp packaging may provide either the month and year of manufacture without abbreviation, or information to allow the date to be readily decoded.

(v) A label may contain statements or illustrations in addition to those required by this paragraph if the additional statements are not false or misleading in any particular; e.g., if they do not diminish the impact of the required statements;

and are not prohibited by this chapter.

(e) Instructions to be provided to users. Each manufacturer of a sunlamp product and ultraviolet lamp shall provide or cause to be provided to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, adequate instructions for use to avoid or to minimize potential injury to the user, including the following technical and safety information as applicable:

(1) Sunlamp products. The users’ instructions for a sunlamp product shall contain:

(i) A reproduction of the label(s) required in paragraph (d)(l) of this section prominently displayed at the beginning of the instructions.

(ii) A statement of the maximum number of people who may be exposed to the product at the same time and a warning that only that number of protective eyewear has been provided.

(iii) Instructions for the proper operation of the product including the function, use, and setting of the timer and other controls, and the use of protective eyewear.

(iv) Instructions for determining the correct exposure time and schedule for persons according to skin type.

(v) Instructions for obtaining repairs and recommended replacement components and accessories which are compatible with the product, including compatible protective eyewear, ultraviolet lamps, timers, reflectors, and filters, and which will, if installed or used as instructed, result in continued compliance with the standard.

(2) Ultraviolet lamps. The users’ instructions for an ultraviolet lamp not accompanying a sunlamp product shall contain:

(i) A reproduction of the label(s) required in paragraph (d) (1) (i) and (2) of this section, prominently displayed at the beginning of the instructions.

(ii) A warning that the instructions accompanying the sunlamp product should always be followed to avoid or to minimize potential injury.

(iii) A clear identification by brand and model designation of all lamp models for which replacement lamps are promoted, if applicable.

(f) Test for determination of compliance. Tests on which certification pursuant to 1010.2 is based shall account for all errors and statistical uncertainties in the process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with age of the product. Measurements for certification purposes shall be made under those operational conditions, lamp voltage, current, and position as recommended by the manufacturer. For these measurements, the measuring instrument shall be positioned at the recommended exposure position and so oriented as to result in the maximum detection of the radiation by the instrument.

Dated: Aug. 12, 1985.

Joseph F. Hile,
Associate Commissioner for Regulatory Affairs
(FR Doc. 85-21253 Filed 9-5-85; 8:45 a.m.)
BILLING CODE 4160-0-M