Chapter 3

Chapters
1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9
2007-08 Lamp Application Guide

Regulation Issues
Food And Drug Administration— The Law In General
FDA Amendment 21 CFR Part 1040, Effective September 1986
FDA District Office Addresses
FDA Notices To Manufacturers
FDA Amendment 21 CFR Part 1040, Effective May 1980 
FDA Amendment 21 CFR Part 352
Possible Tanning Rule Amendments
State And Local Regulations
Sample State Regulations
Regulatory Roundup
State Radiation Control Offices
Legislative Hotline Numbers
Draft Of CRCPD Model Regulations
Underwriters Laboratories
UL 482 Standard For Portable Sun/Heat Lamps
Protective Eyewear 
Protective Eyewear Care
Educating Customers About Eyewear

CHAPTER THREE

Regulation Issues 

The goal of regulatory agencies is to protect the consumer. As the indoor tanning industry continues to grow, these agencies are stretched to the limit in carrying out that primary objective. Because of this, it is ultimately the responsibility of indoor tanning facilities to assure that mandatory regulations as well as sound facility practices are being followed in day-to-day operations—with the health and safety of the tanning consumer utmost in mind.

Local, state and federal regulations are in place to protect the industry as a whole. For those salon owners interested in providing secure, useful products and the longevity of the indoor tanning industry, regulations are a welcomed development. However, it cannot be emphasized enough that self-regulation and adhering to proper business conduct is in the industry’s best interest.

Last year the indoor tanning industry was besieged with anti-tanning propaganda from the media and medical communities, as well as an increase in legislative efforts to ban or restrict indoor tanning. The two biggest issues in 2006 were underage tanning and salon’s making health claims. It looks like 2007 is shaping up to be the same.

Locating rules and regulations, especially those from federal agencies, can be a time-consuming and difficult task, and for this reason we have designed this section to help salon owners understand what the FDA requires and its role in our industry. It contains all FDA regulations that apply to indoor tanning.

This chapter also contains a draft of a model set of state regulations written by the Conference of Radiation Control Program Directors (CRCPD). This draft gives an idea of what typical state rules might include. In addition to these rules and regulations, salon owners and equipment manufacturers also should pay attention to the electrical testing laboratories. UL and ETL are non-profit testing laboratories whose goals are to protect the consumer.

This chapter also includes regulations concerning protective eyewear and provides you with the tools to educate your customers about the importance of protecting their eyes during the tanning process.

Food And Drug Administration
The Law In General

The mission of the Food and Drug Administration is to enforce laws enacted by the U.S. Congress and regulations promulgated by the Agency to protect the consumer’s health, safety and pocketbook.

1. The Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-392), and the Fair Packaging and Labeling Act (15 U.S.C. 1451-1461), which apply to food and drugs for man or animals, cosmetics and medical devices.

2. Sections of the Public Health Service Act relating to biological products for human use (42 U.S.C. 262-263) and control of communicable diseases (42 U.S.C. 264).

3. The Radiation Control for Health and Safety Act, relating to electronic products which emit radiation, such as X-rays, lasers, microwave ovens and TV sets (42 U.S.C. 263b-263n).

The Federal Food, Drug and Cosmetic Act is the basic food and drug law of the United States. With numerous amendments, it is the most extensive law of its kind in the world. Many of the states in the United States have laws similar to the Federal Law, and some have provisions to automatically add any new Federal requirements.

The law is intended to assure the consumer that foods are pure and wholesome, safe to eat and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative and not deceptive. Another law, the Fair Packaging and Labeling Act, affects the contents and placement of information required on the package.

On Nov. 28, 1990, President George Bush signed the Safe Medical Devices Act of 1990 (P.L. 101-629). This law was intended by Congress to strengthen the Federal Food, Drug and Cosmetic Act (FFDCA). One of the consequences of the Safe Medical Devices Act is that the provisions of the Radiation Control for Health and Safety Act of 1968 (RCHSA) have now been transferred to Chapter V of the FFDCA.

The requirements for electronic product radiation control will remain unchanged. The responsibilities of the Food and Drug Administration’s Center for Devices and Radiological Health also will remain the same. The RCHSA, however, has been renamed and re-codified as follows:

RCHSA (old) Chapter V, FDDCA (new) 
Sec. 354, Purpose Sec. 530 
Sec. 355, Definitions Sec. 531 
Sec. 356, Control Program Sec. 532 
Sec. 357, Studies Sec. 533 
Sec. 358, Standards 
Sec. 534 Sec. 359, Defects Correction Sec. 535 
Sec. 360, Imports Sec. 536 
Sec. 360A, Inspections, Records, Reports Sec. 537 
Sec. 360B, Prohibited Acts Sec. 538 
Sec. 360C, Enforcement Sec. 539 
Sec. 360D, Report to Congress Sec. 540 
Sec. 360E, Federal/State Relations Sec. 541 
Sec. 360F, State Standards Sec. 542 

The regulations pertaining to radiation control have not been changed or renumbered. They are still contained in Title 21, Code of Federal Regulations (CFR), Parts 1000 through 1050.

Because indoor tanning can be dangerous when performed improperly, the FDA has stringent rules and regulations that govern the manufacturing and use of devices for indoor tanning.

The FDA has become aware of the rapid development of the tanning industry and has completed an investigation on the use of these devices. As a result of this investigation, the FDA has become concerned with the potential for injury. Use of these products has resulted in several injuries such as “severe sunburn” from overexposure to the ultraviolet radiation and cuts from broken lamps.

A performance standard for sunlamp products (including tanning units) has been published in the Federal Register and is effective for all tanning devices manufactured since May 7, 1980. This regulation was designed primarily to promote the safety of home sunlamps. It was developed after a long period of both public and industry comment.

However, during the FDA’s investigation of commercial tanning it became apparent that other safety precautions were needed in addition to those that are required by the standard. Therefore, the standard was amended in 1985; the new version to be applicable for all tanning devices manufactured on or after Sept. 8, 1986. (Copies of both standards are included in this chapter).

The following document, titled “Equipment Recommendations for Tanning Booths,” was written by the FDA for use until the original standard was amended. This document identifies certain potential safety problems associated with commercial tanning units that weren’t adequately addressed by the earlier regulation and suggests possible approaches that manufacturers may take to eliminate them.

If any products pose a risk to the health of users, the FDA is prepared and authorized to take regulatory action. Safety may be enforced through mandatory or voluntary recalls, injunctions, imposition of fines or seizure of the products. However, in this specific case, the FDA requested that manufacturers of tanning units which did not meet the standard and recommendations voluntarily discontinue production until modifications could be made. In addition, modification of previously manufactured products was recommended as soon as was feasible.

Although these rules and regulations were written specifically for manufacturers, salon owners and operators should be familiar with the rules and regulations that will help them run a safer and more comfortable salon. It also will prove beneficial when educating salon employees and customers.

The following safety problems are identified and possible solutions in the form of equipment recommendations are provided for manufacturers of tanning booths or other similar equipment that provides whole body exposure for tanning purposes. Some of these recommendations may be in addition to the requirements of the Sunlamp Product Performance Standards, reproduced later in this chapter.

User Positioning In The Booth 
The intensity of the radiation to which a user is exposed usually depends upon the distance the user is from the lamp. The intensity of the radiation at contact can be as much as five times higher than that at a distance of 12 inches. Serious burns can occur if the proper exposure distance is not maintained. Installing hand rails, markings on the floor or other suitable physical aids are possible solutions.

Timer Error 
The ultraviolet radiation intensity usually found inside a tanning booth is relatively high when compared to the sun or the intensities associated with smaller home portable sunlamps.

Because of this, allowable exposure times are shorter. Therefore, more accurate control of exposure duration is necessary to decrease the risk of overexposure and injury. A timer having an accuracy of + or - 10 percent of any selected timer interval is sufficiently accurate.

Protective Eyewear 
Exposure of a person’s eyes to ultraviolet radiation may result in eye damage; however, persons being exposed need to see well enough to maintain their balance and to locate the door and the exit quickly and safely should it be necessary. It is important that protective eyewear be provided that protects from ultraviolet radiation and allows adequate vision.

Temperature Control Operation of sunlamps can increase the temperature in an enclosed area. A large increase in temperature might cause fainting and subsequent injury. Units which keep the temperature below 100 degrees F (38 degrees C) would not be cause for concern.

Electrical Safety 
If potential electrical hazards in the unit are not controlled, users, operators and service personnel could be seriously injured. Elevated temperatures cause perspiration which enhances the possibility or severity of an electric shock. Even without perspiration, the skin may come into contact with the interior surfaces which house lamps and ballasts that carry large amount of current. There is a potential for electric shock without proper circuit design and insulation.

In addition, there are potential hazards to operators and service personnel. Changing lamps, turning on the device, etc., can be a hazard if the device is not grounded properly and if ground fault protectors are not included. There also is the possibility of a fire due to circuit overloads, wire shorting and flammable material being used. Electrical hazards will be minimized in booths that conform to currently recognized electrical standards for such equipment. (See UL Standards later in this chapter.) 

Mechanical Construction 
The collapse of a booth might cause electrical shock, fire or direct physical injury. This can be prevented by designing the booth to have had enough strength and rigidity to resist the stress of use and to withstand the impact of a falling person.

Protection From Lamps 
A person can be cut and seriously injured by falling into or bumping against bare sunlamps. This could be prevented by use of physical barriers around the lamps, such as heavy grid wires or ultraviolet transmitting plastics, which are sturdy enough to withstand the impact of a falling person.

Access And Support 
Rapid entrance into or exit from the booth is essential in emergencies. This can be assured by use of doors which open outwardly and are opened easily from both inside and outside of the booth. The potential for injuries from falls can be reduced by use of hand rails and floors which provide adequate traction for wet or dry bare feet.

The Tanning Process 
Skin tanning results from exposure of the skin to ultraviolet radiation in the wavelength region between 260 and 400 nanometers. This region is conventionally subdivided into UVB short wavelength radiation (260 nm to 320 nm) and the longer wavelength UVA radiation (320 nm to 400 nm). Tanning results when melanin pigment is formed in the skin following exposure to ultraviolet radiation. There are two processes for tanning that occur.

Immediate pigment darkening results from photo-oxidation of melanin already present in the melanocyte cells of the skin basal cell layer and is caused primarily by long wavelength ultraviolet radiation.

Delayed tanning results from production of new “packages” of melanin pigment called melanosomes. UVB radiation is much more efficient than UVA in this process. The FDA considers sunlamp products (defined in 21 CFR 1040.20 (b)(9) and ultraviolet lamps (defined in 21 CFR 1040.20 (b)(11) to be both electronic products and medical devices. Therefore, these products and their manufacturers are subject to both the Radiation Control for Health and Safety Act of 1968 (transferred to Chapter V of the Federal Food, Drug and Cosmetic Act in 1991) and the Medical Device Amendments of 1976 (which amended the Food, Drug and Cosmetic Act).

Ultraviolet lamps and accessory equipment have been proposed for classification into Class II. Instructions for preparation of a premarket notification to the Food and Drug Administration and registering a firm as a medical device manufacturer may be found in 21 CFR 801 (Labeling), 21 CFR 803 (Medical Device Reporting), 21 CFR 807 (Establishment Registration and Device Listing for Manufacturers of Devices) and 21 CFR 808 (Exemptions from Federal Preemption of State and Local Medical Device Requirements).

A manufacturer of a sunlamp or sunlamp product is any person engaged in the business of manufacturing, assembling or importing a sunlamp or sunlamp product designated to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living body, by ultraviolet radiation with wavelengths in air between 200 nm and 400 nm, to induce skin tanning.

Manufacturers are required, under Part 1002 of the regulations for the enforcement of the Radiation Control for Health and Safety Act of 1968, to submit an initial report and model change reports for new or modified product models. These reports must be submitted prior to the introduction of a product into commerce and must be prepared in accordance with the “Reporting Guide for Initial Reports and Model Change Reports on Sunlamps and Sunlamp Products.”

The Sunlamp Product Performance Standard, 21 CFR 1040.20, located in the regulations for the enforcement of the Act, initially became effective on May 7, 1980. All sunlamps and sunlamp products manufactured or offered for entry into the United States on or after May 7, 1980, are subject to the code. For products such as suntanning booths, couches or beds, the Center also issued equipment recommendations. In addition to the standard, these recommendations also had to be met prior to introducing a product into commerce.

The standard was amended to include many of the equipment recommendations and better address certain safety issues in September 1985. The amended version took effect on Sept. 8, 1986; all sunlamps and sunlamp products made or submitted for entry into the United States on or after this effective date must comply with the amended standard.

Failure to certify products as required in the code or to provide the required reports or to maintain the required records are violations of Section 538, Chapter V, FDDCA (Section 360B, RCHSA) and may result in the imposition of the penalties, specified in Section 539 (Section 360C, RCHSA).

The reporting and recordkeeping requirements are set forth in Part 1002. In brief, manufacturers, importers and assemblers are required to submit:

1. An initial report (see 1002.10) for each product family which:
a. Identifies models within the reported model family and their intended uses.
b. Describes the nature of radiation emissions associated with those products and the performance and safety characteristics affecting such emissions.
c. Details manufacturer design, quality control, and testing standards and procedures with respect to product radiation and safety.

2. Model change reports (see 1002.12) for each new or different model family.

3. Annual reports which summarize the contents of records maintained by the manufacturer (see 1002.30(a).

Initial and model change reports must be filed prior to the introduction of sunlamps and sunlamp products into commerce. They are to include sufficient information to enable the determination of whether a manufacturer has correctly certified his products as being in compliance with the performance standard.

Annual reports should be submitted by Sept. 1 of each year and should cover the 12-month period beginning on July 1 of the previous year and ending on June 30 of that year.

For aid in submitting the information required in the initial and model change reports, consult the Guide for Preparing Annual Reports. The use of these reporting guidelines is mandatory.

Since the product is also a medical device, manufacturers should be aware of the provisions of the Medical Device Amendments of 1976. Among these provisions are requirements for establishment registration and pre-market notification. Also, section 807.87, paragraph (f) of the regulations requests information on substantial equivalence of the device to similar devices already in commercial distribution.

Cosmetic Standards
In addition, those companies which produce sunscreens, lotions and moisturizers, etc., are subject to 21 CFR part 352, titled “Sunscreen Drug Products for Over-the-Counter Human Use.”

FDA Amendment 21 CFR Part 1040
EFFECTIVE SEPT. 1986

Department of Health and Human Services 
Food and Drug Administration 
21 CFR Part 1040 
[Docket No. 82N-0188] 
Sunlamp Products; Performance Standard 

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.

Supplementary Information:

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

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 longterm 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.

Effective Date

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.

References

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.

Economic Impact

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 ultraviolet lamp, the ratio of the irradiance within the wavelength range of greater than 200 nm through 260 nm to the irradiance within the wavelength range of greater than 260 nm through 320 nm may not exceed 0.003 at any distance and direction 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 “singlecontact 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.

FDA District Office Addresses

The following is a regional breakdown of U.S. Food and Drug Administration District Offices. All requests for additional forms to the Registration Monitor can be obtained at these offices. If you have any questions regarding the FDA and indoor tanning you can contact the office within your state. This information also is available online at www.tanningtraining.com. 

Click here to view List

FDA Notices To Manufacturers

In addition to the code published in the Federal Register, the FDA periodically distributes notices to all manufacturers, importers and potential manufacturers of sunlamp products, clarifying general policy guidelines. These notices may serve the purpose of rectifying widespread instances of noncompliance by ensuring that the standard is understood, or of informing all interested parties that changes in the standard itself are imminent.

In the months before the amended version of 21 CFR 1040 took effect in 1986, two notices were sent to inform all manufacturers, importers and potential manufacturers of sunlamp products of the impending changes in timer intervals and lamp compatibility. In June 1985, the FDA had sent a notice to encourage manufacturers and importers to be sure their product labeling was in compliance with the standard.

Although these notices are written principally for manufacturers and importers, salon operators also may find them useful as a “plain-English” description of certain aspects of the code with which their equipment must comply. The notices are as follows:

Date:
June 25, 1985 

To:
All Manufacturers, Importers and Potential Manufacturers of Sunlamp Products.

Subject:
Policy on Warning Label Required on Sunlamp Products.

Background:
The Center for Devices and Radiological Health has found numerous imported and domestic sunlamp products labeled in such a way as to render the label illegible and/or inaccessible to view by the consumer under normal conditions of purchase and use.

Sunlamp products are electronic products as defined by Section 355(2) [42 U.S.C. 263c(2)] of the Radiation Control for Health and Safety Act of 1968 (RCHSA) and medical devices as defined by Section 201(h)(3) of the Federal Food, Drug and Cosmetic Act (FD&C) [21 U.S.C. 321(h)(3)]. The performance standard for sunlamp products (21 CFR 1040.20), promulgated under authority of Section 358 of the RCHSA, requires that labels containing specific information be permanently affixed or inscribed on an exterior surface of the product so as to be legible and readily accessible to view when the product is fully assembled for use. The general labeling provisions for medical devices under 21 CFR 801.5 require adequate directions for use be provided to the user and 21 CFR 801.15 defines the prominence of the required label statements for devices.

Policy:
The intended purpose of the warning label required on sunlamp products is to provide that information necessary for the consumer to make an informed decision regarding the risks of using sunlamp products and to provide adequate directions for skin tanning.

Therefore, the label must be legible and conspicuously placed on the product so as to render it likely to be read by the user under normal conditions of purchase and use. The Agency will consider sunlamp products to be non-compliant with the performance standard under Section 358(a)(1) of the RCHSA and misbranded under Section 502(c) of the FD&C Act if the required product label is not legible and accessible to view for the following reasons:

1) The label required under 21 CFR 1040.20(d)(1) does not appear on a prominent part or panel which is presented or displayed under normal conditions of purchase and/or use.

2) Adequate space is not provided for the required label or the label is not prominently displayed on the device.

3) The normal individual cannot read the label from a distance of 1 meter because of inadequate lettering size and background contrast. Lettering of 10 millimeters (height) for the word “DANGER” and 5 millimeters for the rest of the label information is recommended to meet the visibility requirements.

Date:
Aug. 21, 1986 

To:
All Manufacturers, Importers and Potential Manufacturers of Sunlamp Products.

Subject:
Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.

Background:
The amended performance standard for sunlamp products (21 CFR 1040.20) was published in the Sept. 6, 1985, issue of the Federal Register and became effective Sept. 8, 1986. Any sunlamp product manufactured on or after that date must comply with the amended standard.

The 10-minute maximum timer interval requirement was removed from the original performance standard since there are newer sunlamp products on the market for which 10 minutes is not appropriate. The maximum timer interval now depends on the intensity and spectral distribution of ultraviolet (UV) radiation emission of each individual model of sunlamp product and must not exceed the maximum recommended exposure time provided on the required product warning label. Therefore, sunlamp product manufacturers must develop an exposure schedule and establish the maximum recommended exposure time (and therefore the maximum timer interval) based on the characteristics of their particular products.

The intended purposes of a sunlamp product timer are to provide for reliable control of exposures and to limit acute (and delayed) damage from unintentionally long exposures. However, the maximum timer setting also should allow for selection of exposure times needed to build up and maintain a tan. The maximum timer interval is in no way to be considered a safe limit; all ultraviolet radiation is potentially hazardous.

The standard requires the manufacturer to provide an exposure schedule in the product warning label. The purpose of the exposure schedule is to allow a person to build up skin pigmentation gradually and to maintain a tan while controlling the risk of acute injury and delayed adverse effects. Since the UV radiation dose that causes a barely discernible pink coloration (minimum erythemal dose or MED) is not the same for different skin types, the exposure schedule for first-time users will depend on the skin type of the user. Furthermore, suberythemogenic doses of UV radiation received at 24-hour intervals initially lead to lowering of the erythema and tanning thresholds. Therefore, the exposure schedule and maximum recommended exposure time should be constrained by the potential for erythema as well as the quantity of radiation necessary to achieve and maintain a tan.

Policy:
The Center for Devices and Radiological Health (CDRH) will use the following criteria to evaluate the adequacy of the exposure schedule and the recommended maximum exposure time (and therefore the maximum timer interval):

1). The maximum recommended exposure time (and maximum timer interval) must not exceed a value which will result in an exposure of four times the minimum erythema dose (MED) for untanned Type II skin (always burns, then tans slightly). This is based on the CDRH Erythema Action Spectrum [proposed action spectrum of the Commission Internationale de L’Eclairage (CIE) modified by CDRH].

2). The recommended maximum exposure time must not exceed a value which will result in an exposure of four times the minimal melanogenic dose (MMD) for untanned Type II skin. This is based on the melanogenic action spectrum developed by Parrish et al (1982).

3). The recommended exposure schedule should provide for exposures of no more than 0.75 MED three times the first week, gradually increasing the exposure time the following weeks until maximum tanning has occurred (approximately four weeks total) and then provide for maintenance of a tan by biweekly or weekly exposures of up to four MEDs or four MMDs, whichever is less.

CDRH believes that the above criteria balances the need to limit acute (and delayed) damages from unintentionally long exposure and the need to provide for single exposure durations adequate to achieve and maintain a tan.

Date:
Sept. 2, 1986 

To:
All Manufacturers, Importers and Potential Manufacturers of Sunlamps.

Subject:
Policy on Lamp Compatibility 

Background:
The amended performance standard for sunlamp products (21 CFR 1040.20) was published in the Sept. 6, 1985, issue of the Federal Register and became effective Sept. 8, 1986. Any ultraviolet lamp (intended to be used in sunlamp products) and sunlamp products manufactured on or after that date must comply with the amended standard.

The amended standard requires the user instructions of an ultraviolet lamp not accompanying a sunlamp product to contain a clear identification by brand name and model designation of all lamp models for which the replacement lamps are promoted, if applicable [21 CFR 1040.20(f)(2)(iii)]. As stated in the preamble of the amendment to the standard (Federal Register issue of Sept. 6, 1985), the promotion of incompatible lamps will be considered as marketing a falsely certified product.

The Center for Devices and Radiological Health (CDRH) has been asked what criteria will be used to evaluate lamp compatibility.

Policy:
A replacement lamp will be considered compatible with (or equivalent to) another (original) lamp if:

1). The replacement lamp will not cause any sunlamp product intended to use the original lamp to fail to comply with the standard or to become defective as defined by 21 CFR 1003.2 and;

2). The lamp is as effective, within + or - 10 percent, as the original lamp, in causing erythema and melanogenesis. 

It should be noted that the above criteria apply to the sunlamp product exposure and maximum timer interval which must appear on the product’s labeling. The manufacturer should use the following procedure to establish conformance with criterion number 2 above:

1). Calculate the recommended maximum exposure time for a single original lamp (Y) using the CDRH Aug. 21, 1986, guidance (Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products).

2). Calculate the recommended maximum exposure time for a single replacement lamp (X) using the same method.

3). Compare the values. If the value for the replacement lamp (X) is within plus or minus 10 percent of the value of the original lamp (Y), the lamp would be considered compatible [X+Y±10%].

The distance(s) used for this comparison should represent the typical use-distance range in products using the original (Y) lamp.

The CDRH welcomes comments on this policy.

(a) Applicability. The provisions of this section are applicable as specified herein to the following products manufactured on or after May 7, 1980.

(1) Any sunlamp product.

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

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

(1) “Intended” means the same as “intended uses” in 801.q of this chapter.

(2) “Irradiance” means the radiant power incident on a surface divided by the area of the surface, as the area becomes vanishingly small, expressed in units of watts per square centimeter (W/cm2).

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

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

(5) “Minimum use distance” means the least distance from the ultraviolet lamp at which the user should be exposed to radiation from the product, as recommended by the manufacturer.

(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 180 nm and 320 nm, to induce skin tanning.

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

(11) “Ultraviolet lamp” means any lamp which produces radiation in the wavelength interval of 180 nm to 320 nm in air and is intended for use in any sunlamp product.

(c) Performance requirements.

(1) Irradiance ratio limits. For each sunlamp product and ultraviolet lamp, the ratio of the irradiance within the wavelength range of greater than 180 nm through 260 nm to the irradiance within the wavelength range of greater than 260 nm through 320 nm shall not exceed 0.003 at any distance and direction from the product or lamp.

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

(ii) The maximum timer interval shall not exceed the recommended maximum exposure time as indicated on the label required by paragraph (d)(1)(vii) of this section, or 10 minutes, whichever is less. This requirement does not preclude a product from allowing a user to reset the timer before the end of the preset time interval. No timer interval shall have an error greater than 10 percent of the maximum timer interval of the product.

(3) Control for termination of radiation emission. Each sunlamp product shall incorporate a control on the product to enable the user manually to terminate radiation emission from the product at any time with-out disconnecting the electrical plug or removing the ultraviolet lamp.

(4) Resumption of radiation emission. When radiation emission from a sunlamp product has been terminated for any reason, including termination by a timer, resumption of such emission shall not be possible until the product is reactivated manually by the user.

(5) 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 (f)(1)(iii) of this section recommend to be exposed simultaneously to radiation from such product.

(ii) The spectral transmittance of the protective eyewear required by paragraph (c)(5)(i) of this section shall not exceed a value of 0.001 over the wavelength range of greater than 180 nm through 320 nm and a value of 0.01 over the wavelength range of greater than 320 nm through 360 nm, and shall be sufficient over the wavelengths greater than 360 nm to enable the user to see clearly enough to read the labels and reset the timer.

(6) Compatibility of lamps. An ultraviolet lamp shall not be capable of insertion and operation in any of the following lampholders:

(i) “Single-contact medium screw,” described in American National Standard C81.10-1976.

(ii) “Double-contact medium screw,” described in American National Standard C81.10-1976.

(d) Label requirements. In addition to the labeling requirements in Part 801 of this chapter and the certification and identification requirements of 1010.2 and 1010.3 of this chapter, each sunlamp product and ultraviolet lamp shall be subject to the labeling requirements prescribed in this paragraph and paragraph (f) of this section. All labels prescribed in this paragraph shall be permanently affixed or inscribed on an exterior surface of the product so as to be legible and readily accessible to view when the product is fully assembled for use.

(1) Each sunlamp product shall have a label which contains:

(i) The words “DANGER—Ultraviolet radiation. Follow instructions. As with natural sunlight, overexposure can cause eye injury and sunburn; repeated exposure may cause premature aging of the skin and skin cancer. Medications or cosmetics applied to the skin may increase your sensitivity to ultraviolet light. Consult physician before using lamp if taking any medication or if you believe yourself especially sensitive to sunlight.”

(ii) Designation of the ultraviolet lamp type which is to be used in the product.

(iii) A recommended minimum use distance specified both in meters and in feet (or in inches).

(iv) Directions for measuring the minimum use distance.

(v) A warning that exposure at distances less than the minimum use distance is not recommended.

(vi) A warning to use protective eyewear whenever the product is energized.

(vii) A recommended maximum exposure time in minutes.

(viii) A recommendation for duration, frequency and spacing of sequential exposures.

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

(2) 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) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by 1010.2(b) and 1010.3(a) of this chapter, 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. When the tags or labels required by 1010.2(b) and 1010.3(a) of this chapter are affixed or inscribed on the ultraviolet lamp packaging, the name of the manufacturer and month and year of manufacture required to be permanently 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, Bureau of Radiological Health, with the key to such code or symbols and the location of the coded information or symbols on the ultraviolet lamp.

(e) Test for determination of compliance. Tests on which certification pursuant to 1010.2 of this chapter is based shall account for all measurement errors and statistical uncertainties in the measurement process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with age of the product. The measurements shall be made under those operational conditions and procedures that maximize the emission of radiation and with the measuring instrument so positioned and so oriented as to result in the maximum detection of the radiation by the instrument. However, the measuring instrument shall be no closer to the product than the minimum use distance. Such measurements shall be made at a test voltage up to 130 root-mean-square volts if the sunlamp product or ultraviolet lamp is designed to operate from nominal 100 to 120 root-mean-square volt power sources. If the sunlamp product or ultraviolet lamp is designed to operate from a power source having some voltage other than from nominal 100 to 120 root-mean-square volts, the measurement shall be made at a voltage up to 110 percent of the maximum nominal root-mean-square voltage specified by the manufacturer for the power source.

(f) 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, instructions for safe use, including the following technical and safety information as applicable:

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

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

(ii) A prominently displayed statement containing the words “DANGER—Ultraviolet radiation. Follow instructions. As with natural sunlight, overexposure can cause eye injury and sunburn; repeated exposure may cause premature aging of the skin and skin cancer. Medications or cosmetics applied to the skin may increase your sensitivity to ultraviolet light. Consult physician before using lamp if taking any medication or if you believe yourself especially sensitive to sunlight.”

(iii) 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.

(iv) 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 user’s instructions for an ultraviolet lamp not accompanying a sunlamp product shall contain:

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

(ii) A statement prominently displayed containing the words “DANGER—Ultraviolet radiation. Follow instructions. As with natural sunlight, overexposure can cause eye injury and sunburn; repeated exposure may cause premature aging of the skin and skin cancer. Medications or cosmetics applied to the skin may increase your sensitivity to ultraviolet light. Consult physician before using lamp if taking any medication or if you believe yourself especially sensitive to sunlight.”

(iii) A warning that the instructions accompanying the sunlamp product should always be followed to avoid or to minimize potential injury. (Sec. 358, 82 Stat. 1177-1179 (42 U.S.C. 263f).

AGENCY: 
Food and Drug Administration.

ACTION: 
Proposed rule.

SUMMARY: 
This proposed rule would establish conditions for the safety, effectiveness and labeling of over-the-counter (OTC) sunscreen drug products. The proposed rule, based on the recommendations of the Panel on Review of Topical Analgesic including antirheumatic, otic, burn, and sunburn treatment and prevention drugs is part of the Food and Drug Administration’s ongoing review of OTC drug products.

SUPPLEMENTARY INFORMATION: 
Pursuant to part 330 (21 CFR Part 330), the Commissioner of Food and Drugs received on Dec. 14, 1977, a report of the Advisory Review Panel on Over-The-Counter (OTC) Topical Analgesic, Antirheumatic, Otic, Burn and Sunburn Prevention and Treatment Products. In accordance with 330.10(a)(6).

(21 CFR 330.10(a)(6), the Commissioner is issuing (1) a proposed regulation containing the monograph recommended by the Panel, which establishes conditions under which OTC sunscreen drugs are generally recognized as safe and effective and not misbranded; (2) a statement of the conditions excluded from the monograph on the basis of a determination by the Panel that they would result in the drugs generally not being recognized as safe and effective or would result in misbranding: (3) a statement of the conditions excluded from the monograph on the basis of a determination by the Panel that the available data are insufficient to classify such conditions under either (1) or (2) above; and (4) the conclusions and recommendations of the Panel to the Commissioner. The minutes of the Panel meetings are on public display in the office of the hearing Clerk (HFA-305), Food and Drug Administration (address given above).

The purpose of issuing the Panel’s unaltered conclusions and recommendations is to stimulate discussion, evaluation, and comment on the full sweep of the Panel’s deliberations. The Commissioner has not yet fully evaluated the report; the Panel’s findings are being issued as a formal proposal to obtain public comment before the agency reaches any decision on the Panel’s recommendations. The report has been prepared independently of the Food and Drug Administration (FDA). It represents the best scientific judgment of the Panel members but does not necessarily reflect the agency position on any particular matter contained in it.

The Commissioner recognizes that extensive changes will result in the current marketing practices of these products if the Panel recommendations are fully implemented. The Panel’s recommendations include many labeling revisions. One of these labeling recommendations is the statement “Overexposure to the sun may lead to premature aging of the skin and skin cancer. The liberal and regular use over the years of this product may help reduce the chance of premature aging of the skin and skin cancer.” As with other of the Panel’s recommendations, the Commissioner is not at this time making a final decision with regard to this labeling. However, he finds it necessary to comment that the issue is important and requires careful study.

Because of the critical nature of the disease conditions involved, the wording of any claim concerning them must be very carefully considered especially because three of the seven panel members oppose the use of the recommended statement. Special attention must be given to assure that consumers are not misled or confused. The Commissioner recognizes the potential for such a statement to mislead the public, and is concerned about its use.

However, the issue is open and will receive the fullest attention before any claim with regard to skin cancer or aging of the skin is included in any OTC drug monograph. After careful review of all contents submitted in response to this proposal, the Commissioner will issue a tentative final regulation in the FEDERAL REGISTER to establish a monograph/ or OTC sunscreen drug products.

In accordance with 330.10(a)(2) (21 CFR 330.10(a)(2), all data and information concerning OTC sunscreen drug products submitted for consideration by the Panel have been handled as confidential by the Panel and FDA. All such data and information will be put on public display at the office of the Hearing Clerk, Food and Drug Administration, after Sept. 25, 1978, except to the extent that the person submitting it demonstrates that it still falls within the confidentiality provisions of 18 U.S.C. 1905 or section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j). Requests for confidentiality should be submitted to William E. Gilbertson Bureau of Drugs (HFD-510).

Based on the conclusions and recommendations of the Panel, the Commissioner proposes the following:

1. That the conditions included in the monograph, under which the drug products generally would be recognized as safe and effective and not misbranded (category I), be effective 30 days after the date of publication of the final monograph in the FEDERAL REGISTER.

2. That the conditions excluded from the monograph because they would cause the drug to be not generally recognized as safe and effective or to be misbranded (category II), be eliminated from OTC drug products effective six months after the date of publication of the final monograph in the FEDERAL REGISTER regardless whether further testing is undertaken to justify their future use.

3. That the conditions excluded from the monograph because the available data are insufficient (category III) to classify such conditions either as category I or category II be permitted to remain on the market, or to be introduced into the market after the date of publication of the final monograph in the FEDERAL REGISTER, provided that FDA receives notification of testing in accordance with 330.10(a)(13) (21 CFR 330.10(a)(13). The Panel recommended that a period of two years be permitted for the completion of studies to support the movement of category III conditions to category I. The Commissioner will review that recommendation as well as all comments on this document, and will determine what time period to permit for category III testing after that review is completed.

In the FEDERAL REGISTER for Jan. 5, 1972 (37 FR 85), the Commissioner of Food and Drugs announced a proposed review of the safety, effectiveness and labeling of all OTC drugs by independent advisory review panels. In the FEDERAL REGISTER of May 11, 1972 (37 FR 9464), the Commissioner published the final regulations providing for the OTC drug review under 330.10 which were made effective immediately. Pursuant to these regulations, the Commissioner issued in the FEDERAL REGISTER of Dec. 12, 1972 (37 FR 26456), a request for data and information on all active ingredients utilized in topical analgesic, including antirheumatic, otic, burn, sunburn prevention and treatment drug products.

The Commissioner appointed the following Panel to review the data and information submitted and to prepare a report pursuant to 330.10(a)(1) on the safety, effectiveness and labeling of those products:

Thomas G. Kantor, M.D., Chairman, John Adriani, M.D., Col. William A. Akers, M.D., Maxine Bennett, M.D., Minerva S. Buerk, M.D., Walter L. Dickison, Ph.D., and Jerry Mark Shuck, M.D.

The Panel was charged to review submitted data and information for OTC topical analgesic ingredients, including antirheumatic, otic, burn and sunburn prevention and treatment active ingredients. For purposes of this review, the Panel grouped the active ingredients and labeling into four major pharmacologic groups, i.e., external analgesics, skin protectants, topical otics and sunscreens.

The Panel presents its conclusions and recommendations for sunscreen active ingredients in this document. The Panel’s conclusions for topical otic active ingredients were published in the FEDERAL REGISTER of Dec. 16, 1977 (42 FR 63556), and its conclusions for skin protectant active ingredients were published in the FEDERAL REGISTER of Aug. 4, 1978 (43 FR34628).

The Panel’s conclusions and recommendations for external analgesic ingredients will be presented in a later issue of the FEDERAL REGISTER.

The Panel was first convened on March 6, 1973, in an organizational meeting. Working meetings were held on May 8 and 9, July 12 and 13, Sept. 27 and 28, Nov. 3 and 4, Nov. 26 and 27, 1973: Jan. 30 and 31, March 6 and 7, April 10 and 11, May 8 and 9, June 10 and 11, July 17 and 18, Sept. 24 and 25, Oct. 22 and 23, Nov. 26 and 27, 1974; Jan. 21 and 22, March 13 and 14, April 17 and 18, May 21 and 22, July 15 and 16, Sept. 30 and Oct.

1, Nov. 12 and 13, 1975; March 4 and 5, May 19 and 20, June 22 and 23, Sept. 27 and 28, Nov. 18 and 19, 1976; Feb. 23 and 24, May 25 and 26, Aug. 22, 23 and 24, Oct. 25 and Dec. 13, 14 and 15, 1977.

Seven non-voting liaison representatives served on the Panel: Mrs. Jacqueline Pendleton (at the initial meeting), Mrs. Valerie Howard (from May 8, 1973 to Sept. 28, 1973), Lynn Berry (from Nov. 3, 1973 to April 27, 1976), Kathleen A. Blackburn (from July 6, 1976 to Aug. 24, 1977) and Emily Londos (from Oct. 25, 1977). Each was nominated by an ad hoc group of consumer organizations and served as the consumer liaison; and Joseph L Kanig, Ph.D., nominated by the Proprietary Association, and Ben Marr Lanman, M.D., nominated by the Cosmetic, Toiletry, and Fragrance Association, served as the industry liaisons.

The following FDA employees served: C. Carnot Evans, M.D., served as Executive Secretary. Lee Geismar served as Panel Administrator. Lee Quon, R.Ph., served as Drug information Analyst until July 1975, followed by Timothy T. Clark, R.Ph., until July 1973, followed by Thomas H. Gingrich, R.Ph., until July 1976, followed by Victor H. Lindmark, Pharm.D.

The following individuals were given an opportunity to appear before the Panel to express their views either at their own or the Panel’s request on the issues before the Panel:

Joseph P. Armellino, M.D., Charles Bluestone, M.D., Stuart Ericksen, Ph.D., Alexander A. Fisher, M.D., Thomas Fitzpatrick, M.D., Ph.D., J. M. Glassman, M.D., Peter Hebborn, Ph.D., George E. Heinze, Kenneth R. Johannes, Albert M. Kligman, M.D., Howard Maiback, M.D., Edward Marlowe, Ph.D., Kenneth L. Milstead, Ph.D., John Parrish, M.D., Madhue Pathak, M.D., Robert Sayre, Ph.D., Joseph P. Soyka, M.D., Garrett Swenson, Esq., Stephen M. Truitt, Esq. and Frederick Urbach, M.D.

No person who so requested was denied an opportunity to appear before the Panel.

The Panel thoroughly has reviewed the literature and data submissions, has listened to additional testimony from interested persons and has considered all pertinent data and information submitted through Dec. 14, 1977, in arriving at its conclusions and recommendations for OTC sunscreens.

In accordance with the OTC drug review regulations (21 CFR 330.10), the Panel’s findings with respect to sunscreen active ingredients are set out in three categories:

Category I. Conditions under which sunscreen products are generally recognized as safe and effective and are not misbranded.

Category II. Conditions under which sunscreen products are not generally recognized as safe and effective or are misbranded.

Category III. Conditions for which the available data are insufficient to permit final classification at this time.

I. SUBMISSION OF DATA AND INFORMATION Pursuant to the notice published in the FEDERAL REGISTER of Dec. 12, 1972, (37 FR 26156) requesting the submission of data and information on OTC topical sunscreen drugs, the following firms made submissions related to the indicated products:

A. SUBMISSIONS BY FIRMS 
FIRMS AND MARKETED PRODUCTS AVA Inc., 
Garland, Texas 75040, AVA Suntan Lotion. Bonne Bell, Lakewood, Ohio 44107, Sure Tan Gel and Sure Tan Lotion.

Paul B. Elder Co., 
Bryan, Ohio 43506, 
RVP Wide Range Sunscreen, RVP Ultra-Range Sun Protection, RVPlus, RVPaque UltraViolet Occlusive Agent, RVPABA Lipstick.

Elizabeth Arden Inc., 
New York, N.Y. 10022, 
Sun Gelee and Suncare.

Greiter Corp. Inc., 
Weidling, Austria, 
Piz Buin Exclusiv Suntan Cream, Piz Buin Exclusiv Extrem Suntan Cream, Piz Buin Exclusiv Suntan Liquid Cream.

G. S. Herbert Laboratories, 
Irvine, Calif. 92664, 
Eclipse Sunscreen Lotion.

Lanvin-Charles of the Ritz Inc., 
Holmdel Township, N.J. 07733, 
Alexandra de Markoff Lip Emollient, Alexandra de Markoff Allevia Body Treatment, Alexandra de Markoff Allevia Travel Stick, Bain de Soleil Suntan Creme White, Bain de Soleil Suntan Cream, Bain de Soleil Suntan Lotion, Bain de Soleil Leg Make-up, Bain de Soleil Foam Concentrate, Bain de Soleil Bronzer, Imperial Nutricia Moisture Tint, Revenescence Sun Bronze, Revenescence Protective Cream for the Face, Revenescence Extra Protective Cream for the Face, Revenescence Moisture GlowBronze Shade, Revenescence Moisture Glow Liquid-Bronze Shade.

Menley & James Laboratories, 
Philadelphia, Pa. 19101, 
Sea & Ski Golden Tan, Sea & Ski Block Out.

Miles Laboratories Inc., 
Elkhart, Ind. 46514, 
Sungard Lotion.

Plough Inc., 
Memphis, Tenn. 38101, 
Coppertone Improved Shade Suntan Lotion, Coppertone Lipkote Lip Balm, Coppertone Noskote Sunscreen, Coppertone Suntan Cream, Coppertone Suntan Foam, Coppertone Suntan Lotion, Coppertone Suntan Oil, Coppertone Suntan Oil Aerosol Spray, Q.T. Foam, Q.T. Lotion, Sudden Tan, Sun Protective Foam, Sun Shielding Lotion.

Rowell Laboratories Inc., 
Baudette, Minn. 56623, 
Duoshield One and Duoshield Two.

Texas Pharmacal Co., 
San Antonio, Texas 78296, 
A-Fil Cream, Sundare Creamy Lotion, Sundare Clear Lotion, SunStick Lip Protectant, SunSwept Cream.

Westwood Pharmaceuticals Inc., 
Buffalo, N.Y. 14213, 
Presun Lotion.

In addition, the following firms made related submissions:

Amerchol, 
Edison, N.J. 08817, 
Amerscreen P.

Chattem Laboratories, 
Chattanooga, Tenn. 37409, 
Alpaba.

EM Laboratories Inc., 
Elmsford, N.Y. 10523, 
Eusolex 161, Eusolex 232, Eusolex 4360, Eusolex 6300, Eusolex 3573, Eusolex 5563.

Felton International Inc., 
Brooklyn, N.Y. 11237, 
Sunarome.

GAF Corp., 
New York, N.Y. 10020, 
Sulisobenzone.

Givaudan Corp., 
Clifton, N.J. 07104, 
GivTan-F, Parsol MCX and Parsol Hydro.

Greiter Corp., 
Tulsa, Okla. 74101, 
Exclusiv Creme, Exclusiv Milk, Exclusiv Moisture Creme, Exclusiv Oil Lotion, Exclusiv Stick Extrem Creme, Extrem Glacier Creme, Extrem Junior Creme, Extrem Milk, Piz Buin.

Haarmann and Reimer Corp., 
Springfield, N.J. 07081, 
Neo Heliopan AV.

Hill Top Research Inc., 
St. Petersburg, Fla. 33709, Sun Block 253E, Sun Block 256E, Sun Block U-2575.

Ingram Pharmaceutical Co., 
San Francisco, Calif. 94111, 2- Ethylhexyl 2-cyano-3,3-diphenylacrylate.

Van Dyk & Co. Inc., 
Belleville, N.J. 07109, Escalol 106, Escalol 506, Escalol 507.

B. LABELED INGREDIENTS CONTAINED IN MARKETED PRODUCTS AND OTHER INGREDIENTS SUBMITTED TO THE PANEL.

Alcohol 
Allantoin 
Allantoin-p-aminobenzoic acid complex p-Aminobenzoic acid 
Amyl dimethyl PABA 
Amyl para-dimethylaminobenzoate 
Amyl-p-dimethylaminobenzoate 
Beeswax 
Benzophenone-3 
Benzyl alcohol 
BHA BHT 
2-Bromo-2-nitropropane-l,3-diol 
Camphor 
Carbomer 934 
Carboset 
Cellulose gum 
Cetyl alcohol 
Cetyl palmitate 
Cetyl stearyl glycol 
Cinoxate Citric acid 
Clove oil 
Cocoa butter 
Color 
Digalloyl trioleate 
Dihydroxyacetone 
Dimethicone 5-(3,3-Dimethyl-2-norbornyliden)- 
3-penten2-one 3,4-
Dimethylphenyl-g lyoxylic acid sodium salt 
Dimethyl polysiloxane 
Dioxybenzone 
Dipropylene glycol salicylate 
Ethyl alcohol 
2-Ethylhexyl 2-cyano-3,3-diphenylacrylate 
Ethylhexyl-p-methoxycinnamate 
2-Ethylhexyl 
4-phenylbenzophenone-
2-carboxylic acid 
2-Ethylhexyl salicylate 
FD&C yellow No.5 
FD&C red No.4
Fragrances 
Glycerin 
Glyceryl PABA 
Glyceryl stearate 
Homosalate 
Isopropyl myristate 
Isopropyl palmitate 
Lanolin 
Lanolin alcohol 
Lanolin derivatives 
Lanolin oil 
Lawsone (2-hydroxy-1,4-naphthoquinone) 
Menthol 
Menthyl anthranilate 
p-Methoxycinnamic acid diethanolamine 
3-(4-Methylbenzyliden)-camphor 
Methylparaben 
Microcrystalline titanium- coated mica platelets 
Microcrystalline wax 
Mineral oil 
Octyl dimethyl PABA 
Oleth-3-phosphate 
Oxybenzone 
Padimate 
Padimate A 
Padimate O 
Parabens 
Paraffin 
PEG 2 stearate 
Petrolatum 
2-Phenylbenzimidazole 
Polyoxyl-40-stearate 
Polysorbate 60 
Propellant 46 
Propellant 12/114 
Propoxylate of p-aminoethylbenzoate 
Propylparaben 
Propylene glycol 
Propylene glycol stearate 
Quaternium 15 
Red petrolatum 
SD alcohol 40 
Sesame oil 
Silaca 
Sodium carbomer 
Sorbitan oleate 
Sorbitan stearate 
Stabilized aloe vera gel 
Stearyl alcohol 
Sulisobenzone 
Synthetic spermaceti 
Titanium dioxide 
Triethanolamine 
Triethanolamine salicylate 
Triethanolamine stearate 
Water 
Wax 
Zinc oxide

C. CLASSIFICATION OF INGREDIENTS 
1. Active ingredients.

Allantoin combined with aminobenzoic acid (allantoin paminobenzoic acid complex) 
Aminobenzoic acid (p-aminobenzoic acid) 
Cinoxate 
Diethanolamine p-methoxycinnamate (p-methoxycinhamic acid diethanolamine) 
Digalloyl trioleate 5-(3,3-Dimethyl 2 norbornyliden)-3penten-2-one 
Dioxybenzone 
Dipropylene glycol salicylate 
Ethyl 4-[bis(hydroxypropyl)] aminobenzoate (propoxylate of p-aminoethylbenzoate) 
2-Ethylhexyl 2-cyano-3,3-diphenylacrylate 
Ethylhexyl p-methoxycinnamate 
2-Ethylhexyl 4-phenylbenzophenone-2-carboxylic acid 
2-Ethylhexyl salicylate 
Glyceryl aminobenzoate (glyceryl PABA) 
Homosalate 
Lawsone with dihydroxyacetone [dihydroxyacetone; lawsone (2-hydroxy-1,4-naphthoquinone)] 
Menthyl anthranilate 3-(4-Methylbenzylidene)-camphor 
Oxybenzone (benzophenoe-3) 
Padimate A (amyl pdimethylaminobenzoate, amyl paradimethylaminobenzoate, amyl dimethyl PABA, padimate) 
Padimate O (octyl dimethy PABA) 
2.Phenylbenzimidazole-5-sulfonic acid phenylbenzimidazole sulfonic acid) 
Red petrolatum 
Sodium 3,4-dimethylphenyl glyoxylate (3,4-dimethylphenyl-glyoxylic sodium salt) 
Sulisobenzone 
Titanium dioxide 

Possible Tanning Rule Amendments

The Food and Drug Administration requested and was given the go-ahead to develop amendments to the U.S. performance standard for sunlamp products based on certain initiatives of international standards organizations concerning sunlamp products. This came after the FDA’s Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) heard a proposal Oct. 1, 2003, for rule changes associated with indoor tanning products.

Several industry professionals spoke at the TEPRSSC hearing, including representatives from the Indoor Tanning Association, Ultraviolet Research Institute, National Tanning Training Institute, LOOKING FIT magazine and Suntanning Association for Education, as well as a Pennsylvania salon owner.

During the sunlamps session of the meeting, the FDA’s Sharon Miller proposed several regulatory changes regarding indoor tanning on behalf of the FDA. The changes covered warning labels, eyewear, the definition of a manufacturer and more.

Warning Label The proposed revised label must include the following text:

“WARNING— Ultraviolet radiation may cause:

• Injury to the eyes and skin.
• Skin aging.
• Skin cancer.

Read instructions carefully.
Wear protective eyewear provided.
Certain medicines and cosmetics may increase sensitivity to ultraviolet radiation.”

It is recommended that the word “warning” have lettering at least 10 millimeters in height and the rest of the label information be 5 millimeters tall to meet the visibility requirements specified in 21 CFR 1010.3.

Label Placement 

The label must be included in catalogs, specification sheets and descriptive brochures. The FDA proposes: “ ... in all catalogs, specifications sheets, and descriptive brochures and any other purchasing information pertaining to each sunlamp product and ultraviolet lamp, a legible reproduction of the warning statement required by 21 CFR 1040.20 shall be affixed.”

This modification is designed to be used only in promotional material for home tanners.

Definition Of A Manufacturer 

Significant modification of a sunlamp product means recertification as a “manufacturer.” Here are some examples from the FDA: 
“A replacement lamp will be considered compatible with (or equivalent to) another (original) lamp if: 
The replacement lamp will not cause any sunlamp product intended to use the original lamp to fail to comply with the standard or to become defective as defined by 21 CFR 1003.2, and; 
The lamp is as effective, within plus or minus 10 percent, as the original lamp, in causing erythema and melanogenesis.”

However, to harmonize with the international standard for sunlamps, the requirement that the lamps effectiveness be compared on the basis of melanogenesis will be removed and a new requirement based on the CIE nonmelanoma skin cancer action spectrum will be added. (See the section on coding systems for lamps below.) Protective Eyewear UV limits will remain the same as before, but standards for the visible region (> 400 nm) will include a more quantitative definition: “the luminous transmittance shall not be less than 1 percent over the 380 to 780 nm wavelength region and the unweighted transmittance ( 5 nm intervals) over the 400 to 550 nm region shall not exceed 5 percent.” This second requirement is currently part of the international standard for sunlamp products (IEC 6-335-2-27).

New MED Dose The currently used “CIELYTLE” erythema action spectrum will be replaced with the internationally-accepted CIE Reference action spectrum for erythema.

The proposal includes the adoption of a maximum timer setting of 3 minimal erythema doses (MEDs) where an MED is defined as 200 J/m2-effective (wavelength-weighted with the CIE action spectrum). The limit of 3 MEDs provides a biologicallyequivalent dose to what is currently used (4 MEDs), weighted with the CIELYTLE action spectrum and assuming that 1 MED equals 156 J/m2-effective. Limits for the old and new action spectrums are roughly equal to 600 J/m2-effective.

Coding System For Lamps For determining replacement lamps—low pressure, fluorescent types—the following coding scheme shall be used: Wattage - Reflector type code - UV code. Wattage is the nominal lamp wattage, marked “watts” or “W.” The reflector type code is defined as follows:

O—for nonreflector lamps.
B—for lamps with a broad reflector angle.
N—for lamps with a narrow reflector angle.
R—for lamps with a regular reflector.

The following UV code shall be used: UV code = X/Y. X equals the total erythema effective UV irradiance over the range 250-400 nm, and Y equals the ratio of the CIE action spectrum effective UV irradiances

State And Local Regulations

State and local regulations are key elements to keeping the indoor tanning industry running on a level playing field. Since the mid-1980s, a number of states have implemented regulations for businesses that offer indoor tanning services.

With these instances of state level regulation now in place and available to serve as examples for other states, industry experts expect many of the remaining states to be at work on their own regulations. Those already adopted by some states, such as Ohio, California and North Carolina, likely will aid in the development of other local codes. In addition, a model set of rules written by a national organization of state radiation control officers is slated for final approval.

The Conference of Radiation Control Program Directors (CRCPD) is, as its name suggests, a national organization made up of the directors of the radiation control programs of each state. In existence since 1968, its purpose is to share knowledge freely between the states and to set national standards for radiation control.

The purpose of the model regulations is to give governmental agencies at all levels a framework on which to build the codes for their particular state. The CRCPD’s intent is to achieve some national uniformity in this type of regulations. Although the model only addresses radiation control, and skips over some health and cosmetic issues such as sanitation, most local authorities should find it a good starting point, since most of their radiological research is already done for them.

Although some salons owners may view regulation as something to be avoided, industry experts argue that the enforcement of fair and reasonable rules actually will improve the health of the industry by forcing uncommitted and uneducated operators out of the industry and preventing them from causing consumers harm.

Not surprisingly, in Ohio, North Carolina and California, as well as in the handful of counties and cities with regulations in place, the central theme seems to be consumer safety.

Whatever their intent, there are some limits to what local rules can require. States and cities cannot implement any regulation that is substantially different from the FDA regulations, according to FDA representatives. This argument apparently has legal merit, since based on it, an outright ban on tanning equipment in Wakefield, Mass., was challenged a few years back and overturned.

However, Wakefield’s ban is a worst-case example; few local authorities take controls to quite that extreme. More typically, they apply themselves to ensuring that operating procedures are followed to reduce consumer risk. States, counties and cities are fairly consistent in what they address. Most have provisions requiring that all businesses offering tanning be registered, that warning signs be posted, that consumers are adequately notified of the risks of tanning, that protective eyewear is available, that certain minimum cleanliness standards are observed, that minors not be allowed to tan without parental permission and that the state or FDA be notified of any injuries.

The means of enforcement and penalties for violations is not so standardized, but it is typically moderate. Even those local authorities that have such measures at their disposal are slow to use them, usually trying to give salon owners every opportunity to rectify the situation before penalizing them or suspending their licenses.

More states and local agencies than you might think are in the process of developing regulations, and once the CRCPD’s model rules are approved, the process may accelerate further. However, not all local authorities are eager to take on the responsibility of regulating the tanning industry. In South Dakota, the state health, cosmetology and radiation control authorities have had some disagreement over whose job it is and other states have expressed a desire to sidestep the development of regulations altogether and pass the job on to county and city authorities.

However, regardless of who finally takes responsibility to write the rules, the number of tanning businesses affected by state or local codes is growing. Authorities in the following states and local governments either have rules in place, are in the process of writing legislation or have at least requested information to that end from one of the trade associations, the FDA or LOOKING FIT Magazine.

Getting Involved In Regulation Development 

Whether local tanning codes are initiated by industry members, the involvement of salon owners in their development is imperative. Rules written and passed by those with no intimate knowledge of the tanning industry can have unwelcome effects. The aborted Wakefield ban is one example and a recent attempt by the Weights and Measures division of the Department of Health and Human Services in Columbus, Ohio, to regulate tanning unit timers is another.

If it hadn’t been derailed by objections from local salon owners and even the Ohio Board of Cosmetology, the measure would have required timers to be accurate to within five seconds over the length of a session. FDA and Ohio requirements allow timers in tanning equipment a variance of + or - 10 percent, or three minutes over a 30- minute session.

The Board of Cosmetology opposed the local ordinance because the industry in Columbus was already subject to both state and federal regulations, and contradicting rules at the city level made no sense. If the measure had passed, it would have been possible for a salon to be completely in compliance with both the FDA and state codes and still be cited and fined by a Columbus Weights and Measures inspector.

The main intent of the rule seemed to be that customers get at least as much time as they paid for, but no provision was made for customizing exposure time for skin type, demonstrating a clear lack of knowledge about the tanning process and the risks of overexposure. If someone goes to a car wash or a laundromat, it doesn’t hurt them if the timer runs a little long. However, if they’re tanning, it’s far preferable for them to be shortchanged than overexposed.

Clearly, local authorities can benefit from informed input. However, those who have experience in working with legislators on any level recommend that the most important thing to do is to arrange your support and prepare your strategy before ever meeting with them. Learn as much about ultraviolet radiation and its effects as possible. Don’t hesitate to request information from the FDA, a trade association, magazine or manufacturer.

Once you’re armed with the facts, calmly offer constructive advice, not just complaints. The squeaky wheel gets the grease, but it’s annoying all the same. If you have an argument with something, be sure to have a suggested improvement prepared. Give it to them in writing so they can refer back to it in later planning sessions.

Don’t overlook other local businesses as allies either. The greater the number of local business owners who show interest in the developing regulations, the more seriously most authorities will take the process. If addressing authorities at a public meeting, a coalition of salon owners would be well-advised to compare notes and consider electing one spokesperson, rather than having several consecutive speakers rehash the same points over and over again. The easier it is for the council or board to listen and the more reasonably salon owners come across, the better the chances of success.

If regulations are proposed that you do not find objectionable, plan to attend the public hearings anyway and comment on the proposals. There’s no telling what can be changed or added on at the last minute.

It seems that the days of loose operating requirements for tanning salons are numbered, a change that is welcomed by many in the industry. As time goes on, complying with local regulations will become an unavoidable part of operating a salon. Fortunately, the CRCPD model as well as many of the codes currently in effect should act as benevolent precedents, making it less likely that one-sided rulings unfairly inhibit the profitability of providing indoor tanning services to the public.

SAMPLE STATE REGULATIONS

The following is a sample of state regulations for indoor tanning. These regulations were provided by the state of Tennessee.

68-54-101. Short title.—This chapter shall be known and may be cited as the “Tanning Facility Control Act of 1990.” (Acts 1990, ch.845 sec. 1.) Effective dates. July 1, 1990. Cross-References. Consumer Protection, title 47, ch. 18.

68-54-102. Definitions.—As used in this chapter, unless the context otherwise requires: (1) “Tanning device” means any equipment that emits radiation used for tanning of the skin, such as a sunlamp, tanning booth, or tanning bed, and includes any accompanying equipment, such as protective eyewear, timers and handrails; and (2) “Tanning facility” means any place where a tanning device is used for a fee, membership dues, or any other compensation. (Acts 1990, ch. 845, sec. 1.) 68-54-103. Applicability To Health Care Professionals.—The provisions of this chapter do not apply to a licensed health care professional who uses a tanning device for the treatment of patients, if such use is within the lawful scope of practice of such health care professional. (Acts 1990, ch. 845, sec.1.) 68-54-104. Requirements.—(a) A tanning facility must:

(1) Have a trained attendant on duty whenever the facility is open for business;

(2) Provide each customer with protective eyewear that meets the standards for tanning devices established under this chapter;

(3) Not allow a person to use a tanning device if that person does not use the protective eyewear;

(4) Show each customer how to use suitable physical aides, such as handrails and markings on the floor, to maintain proper exposure distance as recommended by the manufacturer;

(5) Limit each customer to the maximum exposure time as recommended by the manufacturer; and (6) Control the interior temperature of a tanning facility so that it does not exceed 34-degrees C.

(b)(1) Either each time a person uses a tanning facility or each time a person executes or renews a contract to use a tanning facility, the person must sign a written statement that the person:

(A) Has read and understood the warnings before using the device; and (B) Agrees to use the protective eyewear that the tanning facility provides.

(2) When using a tanning device a person must use the protective eyewear that the tanning facility provides.

(3) A person between the ages of 14 and 18 must give the tanning facility a statement signed by the person’s parent or legal guardian consenting to the person’s use of a tanning device.

(4) A person under the age of 14 must be accompanied by a parent when using a tanning device. (Acts 1990, ch. 845, sec. 1.) 68-54-105. Penalty.—A violation of any of the provisions of this chapter constitutes a misdemeanor punishable by a fine of not more than $500. Each day on which a violation occurs constitutes a separate offense. (Acts 1990, ch. 845, sec. 1.)

Regulatory Roundup

Salon owners and operators need to pay close attention to proposed regulation changes at all levels—not only to make sure that compliance is met, but also to ensure a voice in the process. The proposal of additions or changes to regulations at the local, county and state level has become an increasing trend, especially in regard to teen tanning. It is critically important for indoor tanning professionals to be active in working together to keep watch of proposed tanning regulations.

Last year brought an increase in proposed tanning legislation and antitanning campaigns, and it looks like 2007 will be no different. In fact, salons surveyed during LOOKING FIT’s 2007 Top 250 Salon search reported that anti-tanning campaigns affected their 2006 season by 16 percent. This number is up from 10 percent the previous year.

In 2006, the indoor tanning industry was besieged with anti-tanning propaganda from the media and medical communities. The two biggest issues were underage tanning and salon’s making health claims. Add to that the introduction of HR 4767, otherwise known as The Tanning Accountability and Notification Act, which was introduced to Congress by Rep. Carolyn Maloney (DNY) and Rep. Ginny Brown-Waite (R-FL). The bill pushed to require the FDA to conduct consumer testing to determine the appropriateness of the current labeling requirements for indoor tanning beds. It also would have required FDA to hold public hearings, solicit comments from the public and report to Congress the determinations it makes in the study. The bill died in committee; however, many view the federal proposal as a sign of increased aggression toward indoor tanning.

Additionally, the Academy of American Dermatology (AAD) and other medical associations teamed up with cosmetic and beauty companies to wave the antitanning stick in the public’s eye. Just look at Cosmopolitan magazine’s 2006 multimedia anti-tanning crusade. Did you know it was co-sponsored by Neutrogena? It doesn’t take a rocket scientist to realize that Neutrogena sells self-tanners and is taking profits from you—the professional skincare consultant.

The indoor tanning industry has a tough road ahead fighting multimillion-dollar public relations firms touting the so-called evils of tanning. It must band together as an intelligent unified voice and spread the Good News about moderate, sensible and responsible exposure to sunlight. This is the only way to take the ammunition out of the hands of the anti-tanning coalition.

Additionally, the anti-tanning drum is beating earlier and louder each year. The American Academy of Dermatology (AAD) launched a highly calculated anti-tanning consumer campaign Oct. 18, 2006 targeting the indoor tanning industry. The campaign targets teenagers and consists of public service advertisements (PSAs) in which teens warn their peers against indoor tanning. This aggressive campaign had national media distribution including television, radio and print advertisements.

The AAD’s campaign speaks to teens in a language they can understand—instant messaging (IM). Approximately 53 million American computer users exchange IMs, many of whom are teens, and the Academy developed the campaign specifically to target this demographic.

Furthermore, the organization is working with Miss Maryland 2006, Brittany Lietz, to help reach its target group—teenage girls. Lietz is a skin-cancer survivor and faults indoor tanning for causing her disease. She won her state pageant with a skin-cancer awareness/anti-tanning platform.

Spread The Good News 

Tanning critics will continue to beat their drums; however, it can be countered largely by the mounting studies favoring sensible, moderate and responsible exposure to light in a controlled atmosphere.

The ITA and a handful of salon operators are doing their best to fight state tanning legislations, but they need help by salon owners stepping up to the plate and helping at the local level. If you are not a member of the ITA, please join by calling (888) 377-0477 or visiting www.theita.com. ITA’s mission is to protect one’s freedom to acquire a tan, and strengthen and advance our industry through research, education and partnerships with organizations whose efforts further its mission. ITA is a non-profit and every dollar salons spent for ITA services is invested back in the industry.

The UV Foundation also is working on some groundbreaking studies that will lend credibility to the benefits of tanning.

Legislative Activities 

The outcome of the proposed legislation listed below directly affects salon owners, operators and customers in the tanning industry. It is extremely important for those in the industry to stay and informed and oppose legislation that could harm the industry. The legislative process can move very quickly in proposing and approving anti-tanning bills, therefore, response from those in the industry must be equally swift.

Active Bills In 2007 

So far, the 2007 legislative season has been very busy for the tanning industry with the continuing issue of teenage tanning dominating proposed legislation. Currently, there are 12 pieces of active proposed bills with the majority seeking to prohibit tanning of minors under age 18.

Federal. HR 945, otherwise known as The Tanning Accountability and Notification Act of 2007, was introduced Feb. 8 by Rep. Carolyn B. Maloney (D-NY). Co-sponsored by Rep. Ginny Brown-Waite (R-FL), Rep. Steven R. Rothman (D-NJ), Rep. Maurice D. Hinchey (D-NY) and Rep. Henry A. Waxman (D-CA), the bill was referred to the House Committee on Energy and Commerce on the same day where it currently remains. Maloney and Brown-Waite were the sponsors of a similar bill, HR 4767, that was introduced to Congress in 2006 and died in committee.

HR 945 would require the Food and Drug Administration (FDA) to conduct consumer testing to determine the appropriateness of the current labeling requirements for indoor tanning devices and determine whether such requirements provide sufficient information to consumers regarding the risks that the use of such devices pose for the development of irreversible damage to the skin, including skin cancer, and for other purposes.

California. AB 105 was introduced to the California Legislative Assembly on Jan. 3 to amend Sections 22705 and 22706 of the Business and Professions Code relating to tanning facilities, also known as the Filante Tanning Facility Act of 1988.

Assemblyman Ted Lieu introduced the proposed bill that would institute further statewide restrictions for tanning salons and customers. Specifically, AB 105 would prohibit a person less than 16 years of age from using a tanning device, would require the parent or legal guardian of a person between ages 16 and 18 to sign the requisite consent form in the presence of a facility owner or employee, and would require that proof of age be provided.

Furthermore, the proposed bill would require tanning salons to conspicuously post warning signs and would require that a warning sign also be posted in the front or main entrance of the tanning facility. The bill would prohibit a tanning facility from claiming that indoor tanning has any known health benefits, and would require a tanning facility timer to be remotely located so that customers could not set their own exposure time.

Colorado. SB 07-023 was introduced in the General Assembly on Jan 10 by Sen. Bob Hagedorn (D) and Rep. Anne McGihon (D). The bill would amend Section 2. 25-5- 1007 of the Colorado Revised Statutes and prohibit the use of an artificial tanning device by a minor under age 18 unless specifically prescribed by a physician. It also would require an owner, employee or operator of an artificial tanning device or tanning facility to verify the age of any person seeking access to an artificial tanning device.

On Feb. 7 the proposed bill passed unamended from the Senate’s Committee on Health and Human Services to the Senate Committee of the Whole. On Feb. 16 the bill passed the Senate’s second reading amended. It was introduced to the House on Feb. 20 and assigned to the Health and Human Services Committee. It also passed the Senate’s third reading the same day.

Connecticut. SB 883 was introduced by Sen. Judith G. Freedman on Jan. 22 and referred to the Joint Committee on General Law. The proposed bill seeks to establish registration and regulation requirements for tanning salons. The bill would require that the general statutes be amended to establish a program of registration and regulation of tanning salons by the Department of Consumer Protection, that such regulation address issues such as equipment specification, required use of protective eyewear, posting of warnings and stringent parental consent requirements for minors and to encourage schools to include sun safety as part of grades K-12 health and science curriculum.

Indiana. SB 288 was introduced on Jan. 11 by Sen. Gary P. Dillon (R) and currently is in the Committee on Health and Provider Services The proposed legislation would require the State Department of Health to prepare the written statement that a customer must read and sign before using a tanning bed in a tanning facility. The bill also would require the department to annually review the written statement; and allow the department to inspect tanning facilities.

Michigan. HB 4146 was introduced Jan. 30 by Rep. Frank Accavitti Jr. (D). The proposed bill would specify and require a written warning statement to be signed annually. If the tanner is under age 18 the statement must be signed by the customer’s parent of legal guardian. Among other things the bill also would require warning signs to be placed in the salon and specify the wording and size of lettering. HB 4146 currently is in the Committee on Commerce.

North Dakota. HB 1154 was introduced in the North Dakota Legislative Assembly Jan. 4 by Rep. George J. Keiser (R) and Sen. Ralph L. Kilzer (R). The bill would create and enact Chapter 23-39 of the North Dakota Century Code relating to regulation of tanning facilities and provide a penalty for violations. Among other things, the proposed legislation would institute several statewide tanning salon restrictions and would prohibit minors under age 16 from tanning indoors. It also would require facilities to prominently post a warning sign in each area where a tanning device is used about the risks of failure to use eye protection, the dangers related to overexposure, and abnormal skin sensitively to tanning devices caused by certain foods, cosmetics and medications.

HB 1154 also would also require customers to sign a statement acknowledging they have read and understand certain notices and warning signs and agree to use protective eyewear. Such statements are to be retained by the tanning facility for the lesser of three years or until the customer signs a new statement.

The bill was amended to parental consent for all persons under age 18 and persons under age 14 are not allowed to use a tanning device without a doctor’s prescription and parental supervision. The amended version passed the House on Jan. 31 and was received in the Senate on Feb. 1.The Senate read the proposed bill on Feb. 13 and referred it to Human Services.

Oregon. SB 340 was introduced Jan. 12 by Sen. Laurie Monnes Anderson (D) and Sen. Bill Morrisette (D). The bill would prohibit minors age 14 or younger from using a tanning device at tanning facility. SB 340 was referred to Health Policy and Public Affairs and a Public Hearing and Work Session was scheduled for Feb. 7.

Utah. SB 52 was introduced on Jan. 12 by Sen. Patricia Jones. The original bill would have required that a parent/guardian be present each visit for minors under age 18. The bill was later amended to require that a parent/guardian come to the facility once a year. The amended bill version passed the Senate on Jan. 30and was sent to the House where it currently resides 

Vermont. H 215 was introduced on Feb. 2 by Rep. Janet Ancel (D), Rep. Harry L. Chen (D) and Rep. Carol Hosford (D). The bill would make it unlawful for a tanning facility operator to allow any person who has not reached age 18 to use any tanning equipment. H 215 is currently in Human Services Committee.

Virginia. SB 1231 was introduced Jan. 10 by Sen. Janet Howell (D). The original bill would have required that an owner shall not allow a prospective customer under age 14 to use a tanning device unless such use is authorized in writing by a licensed doctor of medicine or osteopathy. An owner shall not allow a prospective customer who has attained the age of 14 but is under the age of 18 and is not emancipated under Virginia law to use a tanning device unless such prospective customer’s parent or legal guardian remains with such customer at the tanning facility for the duration of each visit.

The bill later was amended to require the owner or his designee shall obtain every six months the signature of the parent or legal guardian of a prospective customer who is under age 15 and is not emancipated under Virginia law. The amended bill passed the Senate on Feb. 6 and was sent to the House and referred to the Committee on Commerce & Labor. SB 1231 passed the House on Feb. 21.

Washington. SB 5580 was introduced Jan. 24 by Sen. Jeanne Kohl-Welles (D), Sen. Karen Keiser (D) and Sen. Rosa Franklin (D). The bill would require tanning facility businesses to post cancer warning signs. The bill currently is in Senate Committee on Labor, Commerce, and Research & Development.

Bills That Died In 2007 

Mississippi. HB 957 was introduced Jan. 12 by Rep. Mary Ann Stevens (D) and referred to Public Health and Human Services. The bill, which died in committee on Jan. 30, included among other things an act to prohibit the use of tanning devices by children under age 14 and require a consent form (good for 30 days) signed in the presence of an operator for minors between ages 14 and 18.

South Dakota. SB 208 was introduced Jan. 31 by Sen. Alan Hoerth (D), Sen. Sandy Jerstad (D), Sen. Tom Katus (D), Sen. Frank Kloucek (D), Sen. Ryan Maher (D) and Rep. Thomas Van Norman (D), Rep. H. Paul Dennert (D), Rep. Bur Elliott (D), Rep. Marc Feinstein (D) and Rep. Bill Thompson (D).

The bill was referred to Health and Human Services and would have required that no customer under age 18 be permitted to use the tanning facility, require written warning statement, and have a trained operator present at the tanning facility during operating hours. The bill died Feb. 20 in the Health and Human Services Committee.

Bills That Passed Or Became Effective In 2006 

Connecticut Raised Bill 447 requires parental consent for minors age 16 and under.
Kentucky HB151 requires parental consent for minors under age 17 and that a parent to be present for minors under age of 14 to tan.
New Jersey SB 1225 bans minors under age 14 from using a tanning facility.
New York SB 2602 and AB 5733 (companion bill) bans minors under age 14 from tanning and requires signed parental consent for minors between ages 14 to 17.
South Carolina HB 3833 eliminates the annual inspection of indoor tanning and eliminates license fees collected by the department and deposited in the state general fund.

Pending Bills 

New Jersey AB 352 would require an additional large warning sign next to each tanning bed.

Bills That Failed In 2006 

Iowa HB 2738 would have banned tanning for minors under age 15 and would have required parental consent for teens ages 15 to 17.
Maryland HB 1226 would have required additional warning signs and eyewear to be provided free of charge. The sponsor withdrew the bill.
Michigan HB 4580 was a licensing bill that would have required parental consent for minors under age 18 and additional warning signs in the tanning salon.
Minnesota SB 2566 and HB 3519 (companion bill) died in committee.

The bills would have established state standards for all equipment; would have required advanced safety training for operators and parental consent for minors under age 18.

Mississippi HB646 would have increased licensing fees from $35 to $45. The bill was amended to keep the fees at $35.
Mississippi HB 1422 would have required parental consent for minors ages 14 to 17 and banned minors under age 14 from tanning.
Oklahoma SB 2050 would have required licensing and inspection for all salons.
Pennsylvania HB 548 would have required additional warning signs, parental consent for minors age 14 to 18 and a parent to be present for minors to tan under age 14.

To learn more about federal and state regulations, see listings for FDA District Office Addresses, State Radiation Control Offices and Legislative Hotline Numbers in this chapter. Links to these important offices can be found on www.lookingfit.com. 

State Radiation Control Offices

The following list indicates the office in each state that has expressed interest or has taken action with regard to indoor tanning regulations, or the office that most likely is responsible for any action.

Click here to view list

Legislative Hotline Numbers

The following is a complete directory of House and Senate bill status telephone numbers and Web sites for all states. This contact information may be used to obtain the status of a bill pending before any one of the 50 state legislatures, as well as the U.S. Congress. This list may change from session to session, since some numbers are active only during legislative sessions.

Click here to view list

Draft Of CRCPD Model Regulations

The following is a draft copy of the model state tanning regulations being assembled by the Conference of Radiation Control Program Directors (CRCPD), a national organization made up of the directors of the radiation control programs of each state. In existence since 1968, its purpose is to share knowledge freely between the states and to set national standards for radiation control.

The CRCPD’s Regulations Oversight Committee and Executive Board will each meets to review and vote on proposed regulatory models. If approved, the models will be available to any state or local authority to use as a starting point for local regulations. The state code currently in effect in North Carolina is very similar in appearance and content to this draft.

The following is not a final version of the model, and any regulatory authority interested in modeling regulations after it should contact the Conference for a current copy. It is provided here to give an idea of what a typical body of state rules might address.

Draft Part BB Tanning Facilities

Section BB.1 Purpose and Scope

(a) This Part provides for [the registration of tanning facilities using ultraviolet lamps, and] regulation of the maintenance of tanning facilities.
(b) In addition to the requirements of this Part, all facilities are subject to the applicable provisions of other Parts of these regulations.
(c) Nothing in the Part shall be interpreted as limiting the intentional exposure of patients to ultraviolet radiation for the purpose of treatment or use commensurate with the licensed practitioner’s use of a healing art.

Section BB.2 Definitions

The following terms are defined for purposes of the Part:

“Act” means [cite State Radiation Control Act];

“Agency” means [cite appropriate State agency];

“Consumer” means any member of the public who is provided access to a tanning facility in exchange for a fee or other compensation, or any individual who, in exchange for a fee or other compensation, is afforded use of a tanning facility as a condition or benefit of membership or access;

“Healing arts” means [cite appropriate State definition];

“Individual” means any human being;

“Inspection” means an official examination or observation including but not limited to tests, surveys and monitoring to determine compliance with rules, regulations, orders, requirements and conditions of the Agency;

“License” means a license issued by the Agency in accordance with regulations issued by the Agency;

“Licensee” means any person who is licensed by the Agency in accordance with these regulations and the Act;

“Operator” means an individual designated by the Registrant to control operation of the tanning facility and to instruct and assist the consumer in the proper operation of the tanning equipment;

“Person” means any individual, corporation, partnership, firm, association, trust, estate, public or private institution of this State, any other State or political subdivision or agency thereof, and any legal successor, representative, agent, or agency of the foregoing;

“Radiation” means ultraviolet radiation;

“Radiation machine” means any device capable of producing radiation;

“Registrant” means any person who obtains a registration, license, permit or other entitlement from the Agency, and who is obligated to obtain such registration, license, permit or other entitlement from the Agency pursuant to these regulations and the Act;

“Registration” means registration with the Agency in accordance with regulations adopted by the Agency;

“Tanning equipment” means ultraviolet lamps and equipment containing ultraviolet lamps intended to induce skin tanning through the irradiation of any part of the living human body;

“Tanning facility” means any location, place, area, structure or business that provides consumers access to tanning equipment;

“These regulations” means all parts of [cite appropriate rules or regulations];

“Ultraviolet radiation” means electromagnetic radiation with wavelengths between two hundred (200) nanometers and four hundred (400) nanometers.

Section BB.3 Exemptions

(a) General: The Agency may, upon application therefore or upon its own initiative, grant such exemptions or exceptions from the requirements of these regulations as it determines are authorized by law and will not result in undue hazard to public health and safety.

(b) Equipment intended for purposes other than the deliberate exposure of parts of the living human body to ultraviolet radiation, and which produce or emit ultraviolet radiation incidental to its proper operation are exempt from the provisions of this Part.

(c) Radiation machines while in transit or storage incidental thereto are exempt from the provisions of this Part.

Section BB.4 Application For Registration Of Tanning Facilities

(a) Each person having a tanning facility shall apply for registration of such facility with the Agency within [thirty (30)] days following the effective date of these regulations or thereafter prior to the operation of a tanning facility. Application for registration shall be completed on forms satisfactory to the Agency and shall contain all the information required by the form and the accompanying instructions.

(b) The Agency shall require at least the following information on the Application for Registration of Tanning Facilities form:

(1) Name, address and telephone number of the following:

(i) The tanning facility;

(ii) The owner(s) of the tanning facility.

(2) The manufacturer, model number and type of each ultraviolet lamp or tanning equipment located within the facility.

(3) The geographic areas within the State to be covered, if the facility is mobile.

(4) The name of the tanning equipment supplier, installer and service agent.

(5) A signed and dated certification that the applicant has read and understands the requirements of these regulations.

(6) A copy of operating and safety procedures unique to facility operation.

(c) Each applicant shall provide such additional information as the Agency may reasonably require.

Section BB.5 Issuance Of Certificate Of Registration

(a) Upon determination that an applicant meets the requirements of Section BB.4, the Agency shall issue a certificate of registration.

(b) The Agency may incorporate in the certificate of registration at the time of issuance or thereafter by appropriate rule, regulation or order, such additional requirements and conditions with respect to the registrant’s receipt, possession, use and transfer of tanning facilities as it deems appropriate or necessary.

(c) No person shall operate a tanning facility until the Agency has issued the certificate of registration [here insert reference to the relevant administrative procedures for response by the agency].

Section BB.6 Expiration Of Certificate Of Registration

Except as provided in Section BB.7(b), each certificate of registration shall expire at the end of the specified day in the month and year stated therein.

Section BB.7 Renewal Of Certificate Of Registration

(a) Application for renewal of registration shall be filed in accordance with Section BB.4.

(b) In any case in which a registrant not less than 30 days prior to the expiration of his existing certificate of registration has filed an application in proper form for renewal, such existing certificate of registration shall not expire until the application status has been finally determined by the Agency.

Section BB.8 Report Of Changes

The registrant shall notify the Agency in writing before making any change which would render the information reported pursuant to Section BB.4 (b)(1), (2), (3) and (6), contained in the application for registration or the certificate of registration, no longer accurate. This requirement shall not apply for changes involving replacement of designated original equipment lamp types with lamps which have been certified with the FDA as “equivalent” lamps under FDA regulations and policies applicable at the time of replacement of the lamps.

The facility owner shall maintain manufacturer’s literature demonstrating the equivalency of any replacement lamps.

Section BB.9 Transfer Of Certificate Of Registration

No certificate of registration shall be transferable from one person to another or from one tanning facility to another.

Section BB.10 Approval Not Implied

No person, in any advertisement, shall refer to the fact that his or her facility is registered with the Agency pursuant to the provisions of Section BB.4, and no person shall state or imply that any activity under such registration has been approved by the Agency.

(1) Failure of reports, plans or specifications to show that the tanning facility will be constructed, operated or maintained in accordance with the requirements of these regulations;

(2) Submission of incorrect, false or misleading information in the application, reports, plans or specifications;

(3) Failure to construct, operate or maintain the tanning facility in accordance with the application, plans and specifications approved by the Agency except as such maintenance may involve the replacement of lamps by “equivalent” lamps which have been defined in Section BB.8 above;

(4) Operation of the tanning facility in a way that causes or creates a nuisance or hazard to the public health and safety;

(5) Violation of any rules, regulations, standards or requirements adopted by the Agency;

(6) Violation of any condition upon which the certificate of registration was issued;

(7) Failure to allow duly authorized agents of the Agency to conduct inspections at reasonable hours and in a reasonable manner;

[(8) Failure to pay any registration or inspection fees;] (b) Hearing: If any certificate of registration is denied, suspended or revoked, the applicant or registrant may request a hearing in accordance with [here insert reference to applicable administrative procedures act, hearing rules, etc.]

Section BB.12 Construction And Operation Of Tanning Facilities

Unless otherwise ordered or approved by the Agency, each tanning facility shall be constructed, operated and maintained to meet the following minimum requirements:

(a) Physical facilities (1) The following warning sign shall be posted in the immediate proximity (within 1 meter) of each piece of tanning equipment; it shall be readily legible, clearly visible and not obstructed by any barrier, equipment or other item present so that the user can easily view the warning sign before energizing the ultraviolet light-generating equipment:

The lettering on each warning sign shall be at least 10 millimeters high for all words shown in capital letters and at least 5 millimeters high for all lowercase letters.

(2) Only tanning equipment manufactured and certified to comply with 21 CFR Part 1040, Section 1040.20, “Sunlamp products and ultraviolet lamps intended for use in sunlamp products,” shall be used in tanning facilities. Compliance shall be based on the standard in effect at the time of manufacture as shown on the device identification label required by 21 CFR Part 1010, Section 1010.3.

(3) Each tanning equipment shall have a timer which complies with the requirements of 21 CFR Part 1040, Section 1040.20(c)(2). The maximum timer interval shall not exceed the manufacturer’s recommended exposure time.

No timer interval shall have an error greater than plus or minus 10 percent of the maximum timer interval for the product.

(4) Tanning equipment shall meet the National Fire Protection Association’s National Electrical Code.

(5) There shall be physical barriers to protect consumers from injury induced by touching or breaking the lamps.

(6) Additional requirements for stand-up booths:

(i) There shall be physical barriers or other means such as handrails or floor markings to indicate the proper exposure distance between ultraviolet lamps and the consumer’s skin.

(ii) The construction of the booth shall be such that it will withstand the stress of use and the impact of a falling person.

(iii) Access to the booth shall be of rigid construction; doors shall open outwardly. Handrails and non-slip floors shall be provided.

[(7) Here insert references to other appropriate regulations dealing with health, hygiene, safety standards, including electrical standards such as UL, etc.] (b) Protective goggles (1) Each consumer shall be provided with protective goggles and instructions for their use.

(2) Protective goggles shall meet the requirements of 21 CFR Part 1040, Section 1040.20(c)(5).

(3) Protective goggles shall be properly sanitized before each use. Exposure to the ultraviolet radiation produced by the tanning equipment itself is not considered a sanitizing agent.

(4) Each consumer shall wear the protective goggles as instructed.

(c) Operation.

(1) An operator must be present when tanning equipment is operated.

(2) Prior to initial exposure each consumer shall be provided with the opportunity to read a copy of the warning specified in Section BB.12(a)(1). The operator shall then request that the consumer sign a statement that the information has been read and understood. For illiterate or visually handicapped persons, the warning statement shall be read by the operator in the presence of a witness. Both the witness and the operator shall sign the statement.

(3) A record shall be kept by the facility operator of each consumer’s total number of tanning visits and tanning times.

(4) A written report of any tanning injury shall be forwarded to the Agency within five working days of its occurrence or knowledge thereof. This report shall include:

(i) The name of the affected individual;

(ii) The name and location of the tanning facility involved;

(iii) The nature or the injury;

(iv) The name and address of the health care provider, if any; and (v) Any other information considered relevant to the situation.

(5) No minor shall be allowed to use the tanning facility unless the minor provides a consent form signed by the parent or legal guardian. The parent or guardian shall have been provided with the basic information required under Section BB.12(a)(1).

(6) Defective or burned out lamps or filters shall be replaced with a type intended for use in that device as specified on the product label on the tanning equipment, or, with lamps or filters that are “equivalent” under FDA regulations and policies applicable at the time of lamp manufacture.

(7) Each operator must be adequately trained. Proof of training must be maintained in the facility and available for inspection. Training shall include:

(i) The requirements of these regulations;

(ii) Procedures for correct operation of the facility;

(iii) Recognition of injury or overexposure;

(iv) Manufacturer’s procedures for operation and maintenance of tanning equipment; and (v) Emergency procedures in case of injury.

(8) A list of operators trained in accordance with Section BB.12(c)(7) shall be maintained and available at the facility.

Section BB.13 Enforcement And Penalties

[Here insert reference to relevant statutory authority to inspect, cite violations and compel compliance and assess penalties.]

Section BB.14 Severability

If any provision, clause, section, sentence or paragraph of these regulations or the application thereof to any person shall be held to be invalid, such invalidity shall not affect the remaining provisions or applications of the regulations. The valid part of any provision, clause, section, sentence or paragraph shall be given independence from the invalid provisions or applications, and to this end these regulations are hereby declared to be severable.

Section BB.15 Effective Date

[Here insert relevant effective date.]

Underwriters Laboratories Inc. (UL) 

Underwriters Laboratories Inc. was founded in 1984 and is chartered as a not-for-profit organization without capital stock, under the laws of the State of Delaware, to establish maintain and operate laboratories for the examination and testing of devices, systems and materials to determine their relation to hazards to life and property.

UL Standards for Safety are developed under a procedure which provides for participation and comment from the affected public as well as the industry. The procedure takes into consideration a survey of known existing standards, and the needs and opinions of a wide variety of interests concerned with the subject matter of the Standard. Thus manufacturers, consumers, individuals associated with consumer-oriented organizations, academicians, government officials, industrial and commercial users, inspection authorities, insurance interests and others provide input to UL in the formulating of UL Standards for Safety, and keeping them consonant with social and technological advances.

Although UL approval has not been required for tanning beds in the past, many local ordinances and municipalities now require it.

The following is a list of UL rules and regulations that must be met in order to obtain UL approval for sun/heat lamps.

UL 482 Standard For Portable Sun/Heat Lamps

SIXTH EDITION JULY 6, 1987 FOREWORD A. This Standard contains basic requirements for products covered by Underwriters Laboratories Inc. (UL) under its Follow- Up Service for this category within the limitations given below and in the Scope section of this Standard. These requirements are based upon sound engineering principles, research, records of tests and field experience and an appreciation of the problems of manufacture, installation and use derived from consultation with and information obtained from manufacturers, users, inspection authorities and others having specialized experience. They are subject to revision as further experience and investigation may show is necessary or desirable.

B. The observance of the requirements of this Standard by a manufacturer is one of the conditions of the continued coverage of the manufacturer’s product.

C. A product which complies with the text of this Standard will not necessarily be judged to comply with the Standard if, when examined and tested, it is found to have other features which impair the level of safety contemplated by these requirements.

D. A product employing materials or having forms of construction differing from those detailed in the requirements of this Standard may be examined and tested according to the intent of the requirements and, if found to be substantially equivalent, may be judged to comply with the Standard.

E. UL, in performing its functions in accordance with its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party. The opinions and findings of UL represent its professional judgment given with due consideration to the necessary limitations of practical operation and state of the art at the time the Standard is processed. UL shall not be responsible to anyone for the use of or reliance upon this Standard by anyone. UL shall not incur any obligation or liability for damages, including consequential damages, arising out of or in connection with the use, interpretation of, or reliance upon this Standard.

F. Many tests required by the Standards of UL are inherently hazardous and adequate safeguards for personnel and property shall be employed in conducting such tests.

GENERAL

1. Scope

1.1 This standard covers sunlamps, heat lamps and combination sun and heat lamps rated at not more than 125 V. A sunlamp is intended for production of ultraviolet radiation for skin tanning. A heat lamp is intended for production of infrared radiation. A combination sun and heat lamp is intended for production of both ultraviolet and infrared radiation. In the text of this standard, the term sun/heat lamp is intended to cover all types.

1.2 This standard covers portable sun/heat lamps intended for use by non-technically qualified persons in homes, sports facilities, health spas and similar establishments and intended for connection to the power-supply circuit by a flexible cord for use in accordance with the National Electrical Code.

1.3 This standard does not cover lamps intended primarily to provide illumination (although some visible radiation may be produced during the operation of a sun/heat lamp).

1.4 This standard does not cover sun or heat lamps intended for professional use. Professional use lamps are those for use by technically qualified persons in hospitals, nursing homes, medical care centers, clinics, medical offices, laboratories and similar establishments for therapeutic purposes. These therapeutic lamps are covered by the requirements for medical and dental equipment.

1.5 Ultraviolet lamps intended for high intensity, short duration—2 minute maximum first exposure time for most sensitive skin—operation will be subject to an appropriate investigation for any additional requirements as are applicable to a lamp with this feature.

1.6 This standard does not cover bulbs alone but complete appliances.

2. Components

2.1 Except as indicated in paragraph 2.2, a component of a product covered by this standard shall comply with the requirements for that component. See Appendix A for a list of standards covering components generally used in the products covered by this standard.

2.2 A component need not comply with a specific requirement that:

A. Involves a feature or characteristic not needed in the application of the component in the product covered by this standard, or B. Is superseded by a requirement in this standard.

2.3 A component shall be used in accordance with its recognized rating established for the intended conditions of use.

2.4 Specific components are recognized as being incomplete in construction features or restricted in performance capabilities.

Such components are intended for use only under limited conditions, such as certain temperatures not exceeding specified limits and shall be restricted to use only under those specific conditions for which they have been recognized.

3. Units Of Measurement

3.1 If a value for measurement is followed by a value in other units in parentheses, the second value may be only approximate.

The first stated value is the requirement.

3.2 Unless indicated otherwise all voltage and current values mentioned in this standard are rootmean-square (rms).

CONSTRUCTION

4. General

4.1 Portable sunlamps are subject to the Radiation Control for Health and Safety Act of 1968, and the Federal Food, Drug and Cosmetic Act as amended by the Medical Device Amendments of 1976.

5. Frame And Enclosure

5.1 A sun/heat lamp shall be so formed and assembled that it will have the strength and rigidity necessary to resist the abuses to which it is likely to be subjected without increasing its risk of fire, electric shock, or personal injury due to total or partial collapse with resulting reduction of spacings, loosening or displacement of parts, or other serious defects.

5.2 A sun/heat lamp shall have an enclosure of metal or of non-combustible, non-absorptive insulating material such as glass, marble, phenolic composition or of a material determined to be acceptable for the application.

5.3 Among the factors taken into consideration when determining the acceptability of a nonmetallic enclosure are (1) the mechanical strength, (2) resistance to impact, (3) moisture-absorptive properties, (4) combustibility and resistance to ignition from electrical sources, (5) dielectric strength, insulation resistance and resistance to arc tracking and (6) resistance to distortion and creeping at temperatures to which the material may be subjected under conditions of intended or abnormal usage. The material is not to display a loss of these properties beyond the minimum acceptable level as a result of aging. See the requirements in the Standard for Polymeric Materials—Use in Electrical Equipment Evaluations, UL 746C.

5.4 The continuity of the grounding system shall not rely on the dimensional integrity of the nonmetallic material.

5.5 Electrical parts of a sun/heat lamp shall be so located or enclosed that protection against unintentional contact with uninsulated live parts, other than the contacts of a lamp-holder, is provided.

5.6 An opening in an enclosure that contains live or current-carrying parts shall prevent entrance of a 1-inch (25.4 mm) diameter rod and is acceptable if a probe as illustrated in Figure 5.1, inserted through the opening, cannot touch any uninsulated live part or coated-magnet wire that may cause an electric shock. The probe shall be applied in all possible articulated positions before, during and after insertion.

5.7 During the examination of an appliance in connection with the requirements in paragraph 5.5, a part of the outer enclosure that may be removed, without the use of tools, by the user of the appliance (to permit the attachment of accessories, to allow access to means for making operating adjustments, or for another reason) is to be disregarded—that is, it will not be assumed that the part in question affords protection against electric shock.

5.8 The stability of a sun/heat lamp having a stand shall be such that it will not easily overturn under conditions of expected use.

5.9 A sun/heat lamp shall be so constructed that it will not tip over when resting on an inclined plane having an angle of 8 degrees with the horizontal.

5.10 Except for parts needed to perform a working function, an edge, projection or corner of an enclosure, opening, frame, guard, handle or the like shall be smooth and well rounded and not sufficiently sharp to constitute a risk of personal injury in intended use or during user maintenance.

5.11 A guard that is not permanently secured in place is to be investigated to determine its acceptability for the application.

6. Mechanical Assembly

6.1 A sun/heat lamp shall have all parts secured in a substantial and reliable manner.

6.2 A switch that is housed in the enclosure of a lamp, and a lamp- or element-holder, shall be mounted securely and prevented from turning by means other than friction between surfaces.

6.3 A lock washer properly applied is acceptable as a means to prevent turning of a stem-mounted switch.

7. Corrosion Protection

7.1 Iron and steel parts shall be protected against corrosion by galvanizing, plating, painting, enameling, or other equivalent means if the deterioration of such parts would be likely to result in an increased risk of fire, electric shock or personal injury.

7.2 If the oxidation of iron or steel due to the exposure of the metal to air and moisture is not likely to be appreciable— thickness of metal and temperature also being factors— the surfaces of sheet steel and cast iron parts in an enclosure may not be required to be protected against corrosion. The requirement of paragraph 7.1 does not apply to bearings, laminations and the like.

8. Electrical Potentials

8.1 Under any condition of operation—including open- circuit secondary, if the lamp employs an autotransformer—no part of a sun/heat lamp shall have a potential of more than 150 V to ground or to either conductor of the power-supply cord, when it is connected to a supply circuit of maximum rated voltage. If such a lamp has a 2-winding transformer, the maximum difference of potential in the secondary under any condition of operation (including open-circuit secondary) shall be 300 V or less.

9. Cords And Plugs

9.1 If a sun/heat lamp is provided with a directly attached flexible cord, an attachment plug shall be provided on the cord for connection to the supply circuit. If a directly attached flexible cord is not provided, the lamp shall have terminals using male pins, blades or the equivalent that will accommodate an acceptable plug. See paragraphs 9.4,9.5 and 18.2.

9.2 A sun/heat lamp employing a screw shelltype lampholder shall have an attachment plug of either the grounding or polarized type. The grounded conductor of the cord is to be connected to the screwshell of the lampholder and to the grounded blade of the attachment plug. See paragraph 32.7.

9.3 The ampacity of the flexible cord shall be not less than the rated current of the sun/heat lamp.

9.4 Flexible cord provided as part of a sun/heat lamp shall be Type SP-1 or SPT-1, or shall be Type HPD or HPN if the lamp produces a temperature of more than 121 degrees C (250 degrees F) on a surface with which the cord is likely to make contact; or the cord shall be of a type having such properties that it will be at least equally serviceable for the particular application.

9.5 Strain relief shall be provided in the lamp and in fittings of the power-supply cord so that a stress on the cord will not be transmitted to the terminals or wiring inside the lamp or to the terminals of fittings. See Section 26.

9.6 If a knot in a flexible cord serves as strain relief, the surface against which the knot may bear or with which it may come in contact shall be free from projections, sharp edges, burrs, fins, and the like that might damage the insulation of the conductors.

9.7 Means shall be provided to prevent the cord from being pushed into the appliance through the cord entry hole if such displacement is likely to subject the cord to mechanical damage, expose the cord to a temperature higher than that for which the cord is rated, or reduce spacings below acceptable values.

10. Bushings

10.1 At a point where a flexible cord passes through an opening in a wall, barrier, or enclosing case, there shall be a bushing or the equivalent, that shall be secured in place, and shall have a smoothly rounded surface against which the cord may bear. If Type SP-1, SPT- 1, SP-2, SPT-2, HPN, HPD or other cord lighter than HSJ is used, if the wall or barrier is of metal and if the construction is such that the cord may be subjected to strain or motion, an insulating bushing shall be provided. The heat-and moisture-resistant properties of the bushing material shall be acceptable for the particular application.

10.2 If the cord hole is in porcelain, phenolic composition, or other acceptable non-conducting material, a smoothly rounded surface is considered to be the equivalent of a bushing.

10.3 Ceramic materials and some molded compositions are acceptable generally for insulating bushings; but separate bushings of wood, so-called hot-molded shellac and tar compositions, or rubber materials are not acceptable.

10.4 Fiber may be used if the bushing is not less than 3/64 inch (1.2 mm) thick and if it is so formed and secured in place that it will not be adversely affected by conditions of ordinary moisture.

10.5 An insulated metal grommet may be accepted in place of an insulating bushing, provided that the insulating material used is not less than 1/32 inch (0.8 mm) thick and fills completely the space between the grommet and the metal in which it is mounted.

11. Internal Wiring

11.1 Insulated conductors used for the internal wiring of a sun/heat lamp shall be acceptable for the temperature and voltage to which they will be subjected in service.

11.2 An enclosure that houses wires shall be smooth and entirely free from sharp edges, burrs, fins and the like, that may cause abrasion of the insulation on conductors.

11.3 Insulated wires may be bunched and passed through a single opening in a metal wall within the enclosure of the sun/ heat lamp.

11.4 The screw-shell of a lamp-holder and the terminal intended to be connected to the grounded circuit conductor, if any, of the attachment plug shall be connected to that conductor of the cord which is identified as the grounded circuit conductor. No single-pole switch shall be connected in that conductor.

11.5 A splice shall be made mechanically secure and shall provide reliable electrical contact.

11.6 A splice shall be provided with insulation equivalent to that of the wires involved unless permanence of spacing between the splice and other metal parts is provided.

12. Insulating Materials

12.1 Insulating washers, bushings and the like that are integral parts of a sun/heat lamp, and bases or supports for the mounting of live parts shall be of a moisture-resistant material that will not be adversely affected by the temperatures to which they will be subjected under conditions of intended use.

12.2 Insulating material used in a sun/heat lamp is to be considered with respect to its acceptability for the particular application. Materials such as mica, some molded compounds, and certain refractory materials usually are acceptable for use as the sole support of live parts. Some other materials that are not acceptable for general use, such as magnesium oxide, may be accepted if used in conjunction with other more appropriate insulating materials or if so located and protected against mechanical damage and the absorption of moisture. If an investigation is necessary to determine the acceptability of a material, consideration will be given to its mechanical strength, dielectric strength, insulation resistance, heat resistant qualities, the degree to which it is enclosed or protected and any other features that have a bearing on the risk of fire, electric shock and personal injury involved in conjunction with the conditions of intended service.

12.3 In the mounting or supporting of small, fragile, insulating parts, screws or other fastenings should not be so tight as to result in cracking or breaking these parts due to expansion and contraction.

12.4 Combustible or electrically conductive heat-insulating material shall not make contact with uninsulated live parts of the lamp.

13. Lampholders

13.1 A female screw-shell used as a holder for a bulb or heating element shall be of copper or copper alloy and shall be plated with nickel or equivalent oxidation-resistant metal if it operates at a temperature of more than 200 degrees C (392 degrees F); or the screw-shell shall be of other acceptable material.

13.2 A lampholder for a sunlamp shall be of a type other than the conventional right hand thread of the Edison medium base size.

14. Switches

14.1 A switch provided as a part of a sun/heat lamp shall be of a type intended for the particular application, and shall have a current and voltage rating not less than that of the load which it controls. A switch that controls a tungsten filament lamp shall be acceptable for such use.

14.2 A switch provided as part of a sun/heat lamp that uses a transformer shall have a voltage rating not less than that of the primary of the transformer. Unless accepted as being appropriate for that purpose, the switch shall have a current rating not less than twice the current input to the transformer, when loaded to the maximum intended value.

15. Timers

15.1 A sunlamp shall be provided with a timer as part of the lamp to function so as to automatically de-energize the lamp at the termination of the time setting on the timer. The timer may be either built-in (integral with the construction of the appliance) or in series with the supply cord.

15.2 If the timer is in series with the supply cord, and is separable from the lamp, the interconnection shall be of a nonstandard configuration to preclude bypassing of the timer.

15.3 A sunlamp timer shall have a maximum time setting equal to the maximum recommended exposure time indicated in the instructions accompanying the sunlamp. In addition, the timer shall have a sufficient number of time settings that correspond with the time intervals for different exposure positions and expected results as indicated by the marking on the sunlamp. See paragraph 32.12.

15.4 A sunlamp timer shall not have a permanent “on” position. No timer interval shall have an error greater than 10 percent of the maximum timer interval of the product.

15.5 The timer may be equipped with an audible or visual signal to warn of pending shutdown.

15.6 A sunlamp timer shall provide the user with a means to manually terminate radiation emission, unless a separate control is provided for this purpose. Disconnecting the supply cord or removal of the lamp from its holder is not acceptable.

16. Protective Eyewear

16.1 Each sunlamp shall be provided with at least one set of protective eyewear per person recommended in the instructions to be exposed simultaneously to the sunlamp.

16.2 The protective eyewear shall be close fitting and shall protect the eye area from both the front and the sides.

16.3 The spectral transmittance of protective eyewear shall not exceed a value of 0.001 over the wavelength range greater than 200 nanometers through 320 nanometers and a value of 0.01 over the wavelength range greater than 320 nm through 400 nm, and shall be sufficient over the wavelengths greater than 400 nm to enable the user to see clearly enough to read the markings and reset the timer.

17. Spacings

17.1 Except as noted in paragraph 17.2, the spacing between uninsulated live parts of opposite polarity, and between an uninsulated live part and a dead-metal part, shall not be less than the value indicated in Table 17.1. If an uninsulated live part is not rigidly supported, or if a movable dead-metal part is in proximity to an uninsulated live part, the construction shall be such that the required spacing will be maintained under all operating conditions.

17.2 At closed-in points only, such as the screw-and-washer construction of an insulated terminal mounted in metal, a spacing of 3/64 inch (1.2 mm) is acceptable. Within a thermostat, except at contacts, the spacing between uninsulated live parts on opposite sides of the contacts is to be not less than 1/32 inch (0.8 mm) through air and 3/64 inch (1.2 mm) over the surface of insulating material. The construction is to be such that the spacings will be maintained permanently. The requirement of paragraph 17.1 does not apply to the inherent spacings of a component part of the lamp, such as a snap switch; such spacings are determined on the basis of the requirements for the component in question. See paragraph 2.1.

17.3 The spacings and sizes of pin terminals provided on a sun/heat lamp using a detachable heater-cord set shall comply with the requirements given in the Standard for Attachment Plugs and Receptacles, UL 498.

18. Grounding

18.1 If a grounding conductor is provided in the supply cord, all exposed dead-metal parts shall be connected to the grounding conductor.

18.2 A grounding conductor covering of the flexible cord shall be green with or without one or more yellow stripes. The grounding conductor shall be secured to the frame or enclosure of the appliance, which is intended to be grounded, by means of a screw that is not likely to be removed during any servicing operation not involving the power-supply cord, or by other equivalent means. Solder alone shall not be used for securing the grounding conductor. The grounding conductor shall be connected to the grounding blade of the attachment plug.

PERFORMANCE

19. General

19.1 If a sun/heat lamp is intended (mechanically and electrically) for use with lamps of two or more different types, the input test shall be conducted by using the lamp that results in maximum input, and the temperature test shall be conducted with the lamp that results in maximum temperature rises. Exception: If a sun/heat lamp is marked to indicate that it is intended for use with a lamp of a particular type, the tests are to be conducted by using such lamp.

20. Leakage Current Test

20.1 The leakage current of a sun/heat lamp rated for a nominal 120 V supply when tested in accordance with paragraphs 20.3—20.6 shall not be more than 0.5 mA.

20.2 Leakage current refers to all currents, including capacitively coupled currents, that may be conveyed between exposed conductive surfaces of a sun/heat lamp and ground or other exposed conductive surfaces of the sun/heat lamp.

20.3 All exposed conductive surfaces are to be tested for leakage currents. The leakage currents from these surfaces are to be measured to the grounded supply conductor individually as well as collectively where simultaneously accessible and from one surface to another where simultaneously accessible. Parts are considered to be exposed surfaces unless guarded by an enclosure considered acceptable for protection against electric shock as defined in paragraphs 5.5—5.7. Surfaces are considered to be simultaneously accessible when they can be readily contacted by one or both hands of a person at the same time. These measurements do not apply to terminals operating at voltages that do not present a risk of electric shock, such as those supplied from an isolating transformer device operating at a potential not exceeding 30 V rms or 42.4 V peak.

20.4 If a conductive surface other than metal is used for the enclosure or part of the enclosure, the leakage current is to be measured using a metal foil with an area of 10 by 20 centimeters in contact with the surface. Where the surface is less than 10 by 20 centimeters, the metal foil is to be the same size as the surface. The metal foil is not to remain in place long enough to affect the temperature of the sun/heat lamp.

20.5 The measurement circuit for leakage current is to be as shown in Figure 20.1. The ideal measurement instrument is defined in items A— D. The meter that is actually used for a measurement need only indicate the same numerical value for a particular measurement as would the defined instrument. The meter used need not have all the attributes of the defined instrument.

A. The meter is to have an input impedance of 1,500 ohms resistive shunted by a capacitance of 0.15 microfarad.

B. The meter is to indicate 1.11 times the average of the full-wave rectified composite waveform of the voltage across the resistor or current through the resistor.

C. Over a frequency range of 0—100 kHz, the measurement circuitry is to have a frequency response (ratio of indicated to actual value of currents) that is equal to the ratio of the impedance of a 1,500 ohm resistor shunted by a 0.15 microfarad capacitor to 1,500 ohms. At an indication of 0.5 mA, the measurement is to have an error of not more than 5 percent.

D. Unless the meter is being used to measure leakage from one part of a sun/heat lamp to another, the meter is to be connected between the accessible parts and grounded supply conductor.

20.6 A sample of the sun/heat lamp is to be tested for leakage current starting with the as-received condition, but with its grounding conductor if any, open at the attachment plug. The as-received condition being, without prior energization, except as may occur as part of the production-line testing. The supply voltage is to be adjusted to 120 V. The test sequence with reference to the measuring circuit (Figure 20.1) is to be as follows: (See Figure 20.1 on page 86.) 

A. With the switch S1 open, the sun/heat lamp is to be connected to the measuring circuit. Leakage current is to be measured using both positions of switch S2, and with the sun/heat lamp switching devices in all their operating positions.

B. Switch S1 is then to be closed, energizing the sun/heat lamp, and within a period of 5 seconds, the leakage current is to be measured using both positions of switch S2 and with the sun/heat lamp switching devices in all their operating positions.

C. Leakage current is to be monitored until thermal stabilization. Both positions of switch S2 are to be used in determining this measurement. Thermal stabilization is considered to be obtained by operation as in the normal temperature test.

21. Input Test

21.1 The current or power input to a sun/heat lamp shall not be more than 110 percent of the marked rating when the lamp is operated from a circuit of rated voltage.

21.2 To determine compliance with the requirement of paragraph 21.1, the input is to be measured with the lamp at normal operating temperature. For the input test, the rated voltage of a lamp having a marked voltage range (such as 110—120 V) is considered to be the mean of the range.

22. Irradiance Ratio Test

22.1 For each sunlamp, the ratio of the irradiance within the wavelength range of greater than 200 nm through 260 nm to the irradiance within the wavelength range of greater than 260 nm through 320 nm shall not exceed 0.003 at any distance and direction from the product or lamp.

22.2 The measurement shall be made under those operational conditions and procedures as recommended by the manufacturers that maximize the emission of radiation. The measuring instrument shall be so positioned and so oriented as to result in the maximum detection of the radiation by the instrument. The lamp voltage, current and position recommended by the manufacturers shall be used.

22.3 In determining compliance with paragraph 22.1 all measurement errors and statistical uncertainties in the measurement process and, wherever applicable, changes in radiation emission or degradation in radiation safety with age of the product are to be considered.

23. Temperature—Normal Operation Test

23.1 A sun/heat lamp shall not attain a temperature at any point high enough to constitute a risk of fire or to damage any material used in the appliance, nor to indicate temperature rises to specific points greater than those indicated in Table 23.1.

23.2 During the test, the sun/heat lamp is to be supported in the intended manner on a horizontal softwood surface covered with two layers of white tissue paper. The test is to be continued until constant temperatures have been attained.

See paragraph 23.6. Any timer contacts are to be shorted during this test.

23.3 An automatic temperature-regulating or limiting control or other protective device provided as a part of a sun/heat lamp is to be shunted out of the circuit during the temperature tests, unless the control has been shown by an appropriate investigation to be reliable, and unlikely to be defeated by the user.

23.4 All values for temperature rises in Table 23.1 are based on an assumed ambient temperature of 25 degrees C (77 degrees F);

however, tests may be conducted at any ambient temperature within the range of 10—40 degrees C (50—104 degrees F).

23.5 Temperatures are to be measured by thermocouples consisting of wires not larger than No.24 AWG (0.21 mm(2) and not smaller than No.30 AWG (0.05 mm(2). The thermocouples and the related instrument are to be accurate and calibrated in accordance with standard laboratory practice. The thermocouple wires are to conform with the requirements for special thermocouples as listed in the table of limits of error in the Standard for Temperature Measurement Thermocouples, ANSI MC96.1-1982. Thermocouples using iron and constantan No. 30 AWG (0.05 mm(2) wires are to be used with a potentiometer-type instrument whenever a referee temperature measurement by the mocouple is necessary.

23.6 A temperature is considered to be constant when three successive readings, taken at intervals of 10 percent of the previously elapsed duration of the test, but not less than 5-minute intervals, indicate no change.

23.7 If the retention of the asbestos insulation of a heater cord depends upon a fabric braid, the braid shall not be removed nor subjected to a temperature rise of more than 65 degrees C (117 degrees F) unless other means are provided to hold the insulation in place. The jacket of Type HSJ cord shall not be subjected to a temperature rise of more than 35 degrees C (63 degrees F), and that of Type HS to a rise of more than 50 degrees C (90 degrees F), if the protection afforded by the jacket is required.

23.8 Stainless steel and other corrosion-resistant alloys may be used for current-carrying parts in a sun/heat lamp without restriction as to temperature. Plated iron or steel may be used for current-carrying parts where the material is subjected to temperature of more than 100 degrees C (212 degrees F), but plain (unplated) iron or steel is not acceptable, regardless of temperature.

23.9 A sunlamp is to be connected to a circuit of maximum rated voltage for the temperature test.

23.10 A heat lamp having a rated voltage of more than 120 V or less than 110 V is to be connected to a supply circuit of rated voltage for the temperature test; however, if the wattage input to the lamp when so connected is less than the marked wattage rating, the lamp is to be connected to a supply circuit of voltage sufficiently higher to cause a wattage input to the lamp equal to its marked rated wattage. If its voltage rating is within the range of 110 to 120 V, inclusive, the lamp is to be connected to a supply circuit of voltage sufficient to cause a wattage input equal to: 

where W(3) is the marked rated wattage of the lamp and V(3) is the marked rated voltage of the lamp; but, in any case, the voltage of the supply circuit is not to be less than the rated voltage.

23.11 With reference to paragraph 23.10, the rated wattage of a lamp rated in amperes (rather than watts) is considered to be the product of the rated voltage by the rated current.

Click here to view Table 23.1

23.12 The temperature of a coil or winding is to be measured by means of thermocouples mounted on the outside of the coil wrap and by the change of resistance method. If the coil is inaccessible for mounting thermocouples (for example, a coil immersed in sealing compound) or if the coil wrap includes thermal insulation or more than 1/32 inch (0.8 mm) of cotton, paper, rayon or similar insulation, only the change-of-resistance method need be used. For the thermocouple-measured temperature of a coil of an a-c motor, other than a universal motor (items 1 and 3 in Table 23.1), the thermocouple is to be mounted on the integrally applied insulation of the conductor.

23.13 At a point on the surface of a coil where the temperature is affected by an external source of heat, the temperature rise measured by means of a thermocouple may be higher by the following amount than the maximum indicated in Table 23.1: provided that the temperature rise of the coil by the change-of-resistance method is not more than specified in Table 23.1.

23.14 The temperature rise of a winding by the change-ofresistance method is to be calculated from the formula (windings are to be at room temperature at the start of the test): 

in which [delta]t is the temperature rise, R is the resistance of the coil at the end of the test, r is the resistance of the coil at the beginning of the test, t(1) is the room temperature (*)C at the beginning of the test, t(2) is the room temperature (*)C at the end of the test, and k is 234.5 for copper, 225.0 for electrical conductor grade (EC) aluminum. Values of the constant for other grades must be determined.

23.15 If it is necessary to de-energize the winding before measuring R, the value of R at shutdown may be determined by taking several resistance measurements at short intervals, beginning as quickly as possible after the instant of shutdown. A curve of the resistance values and the time may be plotted and extrapolated to give the value of R at shutdown.

23.16 During the temperature test, the temperature of a surface that may be contacted by the user shall not be more than as indicated in Table 23.2. If the test is conducted at a room temperature of other than 25 degrees C (77 degrees F), the results are to be corrected to that temperature.

24. Endurance Test

24.1 The sunlamp timer shall acceptably complete 6,000 cycles of mechanical operation without malfunction and must be operable at the end of the test. Each cycle of operation is to consist of rotating the timer knob to the maximum time position and allowing the timer to operate to the off position.

24.2 Unless the timer contacts have been found to be acceptable for the purpose, they shall be subjected to 50 cycles conditioning. The conditioning load is to consist of an inductive load having a power factor of 70 percent to 80 percent adjusted to 150 percent of the operating current of the lamp. The endurance load is to consist of a tungsten lamp load equal to the operating current of the lamp. The rate of operating is to be such that a minimum of 55 seconds is provided for cooling of the lamp load between cycles. A synthetic tungsten lamp load having equivalent characteristics or a synthetic load that represent the actual current characteristic of the particular lamp load, including inrush, may be used in place of the tungsten lamp load.

25. Temperature Test—Abnormal Operation

25.1 A sun/heat lamp overturned in any position on a softwood surface covered with a double layer of cloth shall not cause the cloth or wood to glow or flame.

25.2 After having been pushed over, the lamp is to be operated under the most severe conditions that will result when it comes to rest without further guiding or propping.

25.3 A sun/heat lamp with its rays directed against a vertical softwood surface covered with a double layer of cloth at any distance from the lamp shall not cause the cloth or wood to glow or flame. The vertical wood surface shall abut a horizontal surface supporting the lamp.

25.4 The distance between the lamp and the vertical wood surface is to be such that maximum heating will occur on the latter.

25.5 A sun/heat lamp, loosely covered with a double layer of cloth, shall not cause the cloth to glow or flame.

25.6 The lamp is to be operated until constant temperatures are attained before covering it with a cloth.

25.7 Wherever cloth is mentioned in the abnormal tests, the cloth is to be bleached cheesecloth, running 14—15 yd(2)/lb (approximately 26—28 m(2)/kg) and having what is known in the trade as a “count of 32 by 28,” that is, for any square inch 32 threads in one direction and 28 threads in the other direction (for any square centimeter, 13 threads in one direction and 11 in the other direction).

25.8 If abnormal conditions in addition to those described in paragraphs 25.1, 25.3 and 25.5 are likely to be obtained in actual service, a sun/heat lamp shall not involve a risk of fire when operated under such abnormal conditions.

25.9 To determine if a risk of fire actually exists, a separate burnout or abnormal heating test is to be conducted with the lamp operating continuously until the ultimate result has been determined. During the test, the lamp is to be supported on white tissue paper on a softwood surface. Among the abnormal conditions to be considered is operation of the lamp with rays directed downward toward the supporting surface to the greatest degree possible.

25.10 An automatic temperature-regulating or limiting control or other protective device provided as a part of a sun/heat lamp is to be shunted out of the circuit during the temperature tests, unless the control has been shown by an appropriate investigation to be reliable, and unlikely to be defeated by the user.

25.11 When operated under such abnormal conditions, a lamp is considered to involve a risk of fire if there is any emission of flame or molten metal or if operation of the lamp results in the glowing or flaming of combustible material upon which it may be placed.

25.12 A heat lamp with reference to the abnormal tests will generally require continuous operation for 7 or 8 hours in order to determine that the ultimate result has been observed. Any timer contacts are to be shorted during the abnormal tests.

25.13 A sunlamp with reference to the abnormal tests will generally require continuous operation for 7 or 8 hours in order to determine that the ultimate result has been observed. The timer contacts are to be shorted during the abnormal tests.

Exception: If the timer has been tested and found to operate acceptably for 100,000 cycles of mechanical and electrical operation following the procedure in paragraphs 24.1 and 24.2, a sunlamp is first to be brought up to constant temperature before introducing the abnormal condition. The timer is then to be set at 10 minutes and the abnormal condition introduced.

25.14 If a sun/heat lamp employs one or more semi-conductors, transistors, or similar components, a risk of fire, electric shock, or personal injury condition shall not develop when the circuit between any two terminals of any such component is short circuited or is opened at any terminal. If an electrolytic capacitor is employed a risk of fire, electric shock or personal injury condition shall not develop when the capacitor is shorted. Only one simulated fault condition is to be imposed at one time.

26. Strain Relief Test

26.1 The power supply cord of a sun/heat lamp shall be capable of withstanding a straight pull of 35 lbf (156 N) applied between the cord and the sun/heat lamp for 2 minutes.

26.2 The 35 lbf (156 N) pull is to be applied by suspending a 35 lb (15.9 kg) weight on the cord with the force applied in a direction normal to the plane of the cord-entry hole, with all supply-cord conductors severed immediately adjacent to the terminals or splices. If there is a movement of the cord of more than 1/16 inch (1.6 mm) at the point where the connections are severed, the strain relief is not acceptable.

26.3 Strain relief shall be provided so that a pull exerted on the flexible cord will not be transmitted directly to binding-screw terminals of the attachment plug. The assembly shall be capable of withstanding a straight pull of 30 lbf (133 N) applied between the cord and the plug.

26.4 With the attachment plug securely held by the blades, the pull is to be applied for 1 minute to the flexible cord, in a direction perpendicular to the plane of the cord-entry hole. The results of the test are not acceptable if any cord conductor is detached from its terminal in the plug.

27. Adhesion of Labels Test

27.1 To determine if a pressure sensitive label or a label secured by cement or adhesive is of a permanent nature, representative samples that have been subjected to the tests outlined in paragraphs 27.2—27.5 shall meet the following conditions:

A. Each label shall demonstrate good adhesion and the edges shall not be curled.

B. The label shall resist defacement or removal as demonstrated by scraping across the test panel with a flat metal blade 1/32 inch (0.8 mm) thick, held at a right angle to the test panel.

C. The printing shall be legible and shall not be defaced by rubbing with thumb or finger pressure.

27.2 For each of the two types of conditioning mentioned in paragraphs 27.3 and 27.5, three samples of the label are to be applied to the same test surface as anticipated in the intended application. The labels are to be applied to the test surface not less than 24 hours prior to testing.

27.3 Three samples of the labels are to be evaluated as received.

27.4 Evaluation of samples at the end of the test as indicated in paragraph 27.5 is to be made (1) immediately following removal from the test medium, and (2) after exposure to room temperature for 24 hours following removal from the test medium.

27.5 Three samples of the labels under test are to be placed in a full-draft circulating-air oven maintained at the temperature indicated in Table 27.1 for 240 hours.

28. Dielectric Voltage-Withstand Test

28.1 A sun/heat lamp shall be capable of withstanding without breakdown for 1 minute the application of a 60 Hz essentially sinusoidal potential between live parts and dead metal parts, with the lamp at the temperature attained in use. For a circuit that operates at a voltage of 250 V or less the potential shall be 1,000 V; for a circuit which operates at a voltage of more than 250 V the test potential shall be 1,000 V plus twice the operating voltage of that circuit. If the lamp uses a 2-winding transformer, it shall also be capable of withstanding without breakdown for 1 minute the application of a 60 Hz essentially sinusoidal potential of 1,000 V plus twice the higher operating voltage of the two windings, between primary and secondary circuits.

28.2 To determine compliance with the requirement of paragraph 28.1, a sun/heat lamp is to be tested by a 500 VA or larger capacity transformer, whose output voltage is essentially sinusoidal and can be varied. The applied potential is to be increased from zero until the required test value is reached, and is to be held at that level for 1 minute. The increase in the applied potential is to be at a substantially uniform rate and as rapid as is consistent with its value being correctly indicated by a voltmeter.

MANUFACTURING AND PRODUCTION-LINE TESTS

29. Production-Line Dielectric Voltage-Withstand Test

29.1 Each appliance shall withstand without electrical breakdown, as a routine production line test, the application of a potential at a frequency within the range of 40—70 Hz, between live parts and dead metal parts. The test potential shall be (1) 1200 V applied for 1 second or (2) 1000 V applied for 1 minute.

29.2 The appliance may be in a heated or unheated condition for the test.

29.3 The test shall be conducted when the appliance is complete (fully assembled). It is not intended that the appliance be unwired, modified or disassembled for the test.

Exception No. 1: Parts such as snap covers or friction-fit knobs that would interfere with performance of the test need not be in place.

Exception No. 2: The test may be performed before final assembly if the test represents that for the completed appliance.

29.4 The test equipment shall include a transformer having an essentially sinusoidal output, a means of indicating the test potential, an audible or visual indicator of electrical breakdown, and either a manual reset device to restore the equipment after electrical breakdown, or an automatic reject feature of any unacceptable unit.

29.5 If the output of the test equipment transformer is less than 500 VA, the equipment shall include a voltmeter in the output circuit that directly indicates the test potential.

29.6 If the output of the test equipment transformer is 500 VA or larger, the test potential may be indicated by (1) a voltmeter in the primary circuit or in a tertiary-winding circuit, (2) by a selector switch marked to indicate the test potential, or (3) in the case of equipment having a single test-potential output, by a marking in a readily visible location to indicate the test potential. When a marking is used without an indicating voltmeter, the equipment shall include a positive means, such as an indicator lamp, to indicate that the manual-reset switch has been reset following a dielectric breakdown.

29.7 Test equipment, other than that described in paragraphs 29.4—29.6, may be used if found to accomplish the intended factory control.

29.8 During the test a sufficient number of primary switching components shall be in the on position so that all primary circuitry will be stressed. Both sides of the primary circuit of the appliance are to be connected together and to one terminal of the test equipment, and the second test-equipment terminal is to be connected to the accessible dead metal.

30. Production-Line Grounding Continuity Test

30.1 Each appliance that has a power-supply cord having a grounding conductor shall be tested, as a routine production-line test, to determine grounding continuity between the grounding blade of the attachment plug and the accessible dead metal of the appliance that is likely to become energized.

30.2 Only a single test need be made if the accessible metal selected is conductively connected by construction to all other accessible metal.

30.3 Any indicating device (an ohmmeter, a battery-and-buzzer combination, or the like) may be used to determine compliance with the grounding continuity requirement in paragraph 30.1.

RATINGS

31. General

31.1 A sun/heat lamp shall be rated in amperes (A) or watts (W), and in volts (V). The rating shall include the frequency (Hz), if necessary, due to relay coils, transformers, or other components.

MARKINGS

Specifics

32.1 A heat lamp shall be legibly and permanently marked where it will be plainly visible with; (1) the manufacturer’s name, trademark, or trade name; (2) the date or other dating period of manufacture not exceeding any three consecutive months; (3) the catalog number or the equivalent; and (4) the electrical rating. A lamp intended for use on alternating current only or on direct current only shall be so marked.

Exception No. 1: The manufacturer’s identification may be in a traceable code when the heat lamp is identified by the brand or trademark of a private labeler.

Exception No. 2: The date of manufacture may be abbreviated or in a nationally accepted conventional code, or in a code affirmed by the manufacturer. A date code repetition time cycle shall not be less than 10 years.

32.2 A sunlamp or a combination sun and heat lamp shall be legibly and permanently marked where it will be plainly visible with (1) the full name and address of the manufacturer, or if the product is sold a name other than the manufacturer, the full name and address of the organization responsible for the product may be used; (2) the month and year of manufacture without abbreviation, with the year shown as a four digit number as follows—” Manufactured: (insert month and year of manufacture);” (3) catalog number or the equivalent; and (4) the electrical rating. A product intended for use on an alternating current only or on direct current only shall be so marked.* Exception: The information required in items 1 and 2 above shall be provided as specified unless a modification is authorized, in writing, by “ Director, Office of Compliance (HFZ- 300), Center for Devices and Radiological Health.”

32.3 If a sun/heat lamp is intended for cleaning or similar servicing by the user that involves the exposure of any enclosed or protected live part to unintentional contact, the appliance shall be plainly marked with a warning that such servicing be done with the supply cord disconnected from the supply circuit.

32.4 If a manufacturer produces or assembles sun/heat lamps at more than one factory, each finished product shall have a distinctive marking, which may be in code, by which it may be identified as the product of a particular factory.

32.5 An individual heating element or unit that is a part of a heat lamp and that is replaceable in the field shall be plainly marked with its electrical rating in amperes (A) or watts (W), and also in volts (V).

32.6 If a heat lamp that will accommodate lamps of two or more different types is tested as described in paragraph 19.1, the appliance shall be plainly marked to indicate that it should be used with a lamp of the type with which it was tested. If lamp is user replaceable, reference to instructions for type and method of replacement shall be provided.

32.7 Instructions for the use of a polarized attachment plug shall be provided with each sun/heat lamp employing a polarized attachment plug. The instructions shall be included on a separate sheet, on an attached tag, or in a separate format in the manufacturer’s instructions booklet. The instructions shall be titled IMPORTANT SAFETY INSTRUCTIONS in letters not less than 3/16 inch (4.8 mm) high, and shall precede the following, or the equivalent text. “ This product has a polarized plug (one blade is wider than the other). As a safety feature, this plug will fit in a polarized outlet only one way. If the plug does not fit fully in the outlet, reverse the plug. If it still does not fit, contact a qualified electrician. Never use with an extension cord unless plug can be fully inserted. Do not attempt to defeat this safety feature.”

• Federal regulations require a marking on all sunlamp products which indicates compliance with the Federal Performance Standard (21 CFR 1040.20). See paragraph 4.1.

32.8 A heat lamp shall be marked or provided with an attached tag or instruction book which contains the word “WARNING” followed by “Use carefully. May cause serious burns. Do not use over insensitive skin areas or in the presence of poor circulation. The unattended use of infrared heat by children or incapacitated persons may be dangerous” or the equivalent.

32.9 A heat lamp using a lampholder of the conventional right hand Edison medium base size shall be marked “ For use with heat lamp only” or equivalent.

32.10 Cautionary markings and instructions intended to instruct the operator shall be legible and clearly visible to the operator in the use of the sun/heat lamp. Cautionary markings shall have the prefix word “DANGER” or “ CAUTION” in letters not less than 3/32 inch (2.4 mm) high.

32.11 Markings shall be permanent and shall be molded, die-stamped, paint-stenciled, stamped or etched on metal, indelible stamped lettering, or a pressure sensitive label secured by adhesive that is acceptable for the particular application, see Section 27.

32.12 A sunlamp shall be permanently marked 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. The label must contain as a minimum: 

A. The words “DANGER—Ultraviolet Radiation.” Follow instructions. Avoid overexposure. 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. 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 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.”

B. Designation of the ultraviolet lamp type that is to be used in the product.

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

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

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

F. A statement of the time it may take before the expected results appear.

G. Catalog designation of protective eyewear.

H. Read the instruction booklet before using lamp.

32.13 A sunlamp shall be provided with an instruction booklet. This booklet shall include the following information as a minimum:

A. A reproduction (color optional) of the label required in paragraph 32.12 prominently displayed at the beginning of the instructions.

B. 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.

C. 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.

D. Instructions for determining the correct exposure time and schedule for persons according to skin type.

E. 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 requirements for the product.

F. Information on warm-up and restart characteristics of the product lamp.

G. Other general information to reduce the risk of injury, such as, use with skin problems, effects with wet skin, use of medications, lotions, skin creams and the like.

H. Assembly instructions, as appropriate, for stands and guards. If guard is shipped disassembled, notice that the guard is to be in place before operating lamp.

I. Bulb replacement and installation, together with cleaning instructions, as applicable.

32.14 A sun/heat lamp shall be completely assembled and shall be packed in a single carton when shipped from the factory except as indicated in paragraphs 32.15—32.17.

32.15 Guards that are not attached during shipping, may be wrapped separately provided assembly instructions are included in the instruction booklet. Instructions shall include a statement that the guard is to be in place prior to use of the lamp. It shall be practical to assemble the guard without introducing a risk of personal injury.

32.16 A stand may be unassembled to facilitate packing.

All hardware and instructions necessary for assembly shall be provided. Unless only ordinary tools (flat-bladed and Phillips screwdrivers, pliers) are required for assembly, any tools required shall be provided. It shall be practical to assemble the stand without introducing a risk of personal injury.

32.17 Bulbs not mounted in the lamp shall be separately wrapped. Instructions for assembly shall be provided in the instruction booklet.

32.18 Protective eyewear shall be marked with manufacturer’s name or trademark and catalog number or equivalent.

(See Appendix A on page 96.) ELECTRONIC TESTING LABORATORIES (ETL) The ETL (Electronic Testing Laboratories) is another independent laboratory that tests and approves tanning equipment.

Like the UL, ETL has been around since the turn of the century. It also follows the same testing procedures as the UL.

ETL also publishes a directory of listed products so manufacturers and retailers may know what products have been tested and approved.

Protective Eyewear

As a responsible salon owner, you can’t stress enough the importance of proper eye-care before, during and after tanning. It is essential to take the high road and educate your tanners about the ramifications of tanning without proper eye protection. Every person who tans at a salon (or who is active outdoors for that matter) should be wearing some sort of eyewear that protects their eyes from ultraviolet light.

But how does a salon owner and his staff open a client’s eyes to the importance of eyewear? The answer lies in the following four facts:

1. Eyewear protects your eyes from potentially harmful ultraviolet light.

2. UV damage is cumulative.

3. The short-term health risk is corneal burns, which is a sunburn on the surface of the eye. It shows up within a few hours of exposure and is characterized by increased sensitivity, a burning sensation and excessive tearing. The effects are apparently temporary and usually disappear within a day or so.

4. The long-term health risk includes brunescent cataracts. Brunescent cataracts are a clouding or pigmentation of the lens within the eye. They are slow to develop, usually occurring over a matter of years, but they are permanent. The clouding affects night vision and also can alter perception of color. Cataract surgery is the only known cure.

There are two common misconceptions regarding eyewear. The first is that eyelids will tan. The second is that closing the eyelid protects the eye. The simple truth is that it does not, therefore, protective eyewear is imperative.

The benefit of not using protective eyewear (no line on the bridge of your nose) doesn’t outweigh the risks involved (long-term damage to the eyes). But, should a salon owner resort to scare tactics to get their customers to use eyewear?

Some experts suggest that salon owners rephrase their approach and promote the benefits, such as keeping your eyesight into old age or enjoying all the colors in the world.

However, scare tactics are always appropriate when dangers exist. Again, it’s nice to state a positive benefit as opposed to a threatening negative, but if dangers truly exist, salon operators have a responsibility to inform their clients.

Public view

There are many issues surrounding protective eyewear. The two that seem to dominate the topic are vanity and apathy.

In talking to salon owners nationwide, they agree that some of their tanners do not wear eyewear, even though it is required by the FDA. One concern is `raccoon eyes.’ They find that their customers would rather damage their eyes than have an untanned ring around them. However, the salon owners did state that a number of manufacturers have improved the design to avoid this common problem.

Another concern tanners have is cleanliness of the eyewear supplied in the tanning room. Obviously, it is the responsibility of the salons to comply with state sanitation statutes, and explain them to their customers. Many salons report that the majority of their customers supply their own FDAapproved eyewear—purchased from a tanning salon. However, they are still required to supply eye protection either at the counter or in the tanning rooms. One salon owner in Kentucky provides disposable eye protection, however, she tends to find them in the trash unused.

An interesting issue is salon owner indifference. Some salon owners don’t attempt to make their customers wear protective eyewear because once they are behind the closed door of a tanning room, there is no way to make sure clients are wearing eyewear. However, if the salon operator has done a strong enough job of promoting the risk/benefit equation—in other words, giving the consumer enough information to make an intelligent decision—then they’ve done their job. The fact is, informed consumers make better decisions.

Another important aspect to eyewear is fit. The goggle should fit snugly around the eyeball. If a client can see out of the sides of the goggle or notices light coming in, they need another pair.

Most customers are concerned with comfort and often choose not to use eyewear because it’s uncomfortable. Eyewear manufacturers have made lots of changes to make sure their products are more comfortable and don’t allow light to seep in, if worn properly. Unfortunately, many tanners don’t choose to follow directions on the package such as wearing the elastic headband to hold the eyewear snugly in place.

Because of the risk of infectious diseases (impetigo, viral or bacterial infections, cold sores and other types of sores) goggles should be disinfected between each use. Remind clients that the risk of infection doesn’t only come from other people, but it’s possible to continually reinfect yourself if you have some type virus or infection.

Not only should eyewear should be cleaned after every use, but they should be disinfected as well.

It has been noted that some salons prefer using the bed cleaner to clean and sanitize the eyewear. The problem here is while the majority of bed cleaners effectively kill germs, some do not at all. So it is extremely important that the cleaning solution:

(1.) Is designed to sanitize and clean all in one function. 

(2.) Has been properly mixed to prevent eye irritation. 

(3.) Is non-toxic and does not leave a film behind. (4.) Will not damage plastics.

(5.) Clearly states on the product label that it will effectively kill all the leading germs and bacteria.

Another important point is that eyewear needs to be replaced. It should be noted that some cleaning solutions are destructive to plastics and acrylics used in reusable eyewear, making it fall below FDA standards. So, salons may think they are providing FDA compliant eyewear when, in fact, they may not be. If a salon insists on providing reusable eyewear to its clients, then the salon should replace eyewear regularly.

Another maintenance point is to replace the headbands as they become worn, frayed or broken. If eyewear is provided with headbands, then headbands are needed to produce proper fit.

A lot of salons are not replacing broken headbands and the result is customers cannot possibly get the proper fit.

Salon owners and their staff don’t have to blindside their clients to make them see the positive benefits of wearing protective eyewear. All that needs to be done is to address the concerns in informal conversations or establish a formal sign-in procedure with your clientele.

Liabilities

What if you’ve done everything possible to warn a customer about the dangers of tanning without protective eyewear and they still don’t utilize them? Will a salon owner be liable for damages?

All states that have rules have what is called a consumer statement. What happens is that the customer signs a document that has the same information that is listed on the warning signs—overexposure may cause premature aging of the skin, skin cancer, etc. It also says eye injury may result, etc. This is a permanent legal document. If a person signs this statement—which they’re supposed to, to be compliant—then the liability is back on the tanner. So the tanner knows that if they burn their eyes, they’ve signed this saying they knew what the consequences were.

According to experts, salons can get into a lot of trouble if they are not regularly making it a point to advise customers of the government regulations, health benefits and risk factors. They need to do this in a bold fashion and as a regular part of greeting a new customer. They can even mention it regularly in their newsletters. The FDA regulation says that not only must there be signs on the equipment, but also that the salon owner must explain the use of protective eyewear to every customer. If they’re not doing it, or if they’re weak on it, then they’re going to be found (or far more likely to be found) liable in professional liability suits.

The only ways for a salon to prove they’ve done their job in warning clients about the risks of not wearing eyewear are:

(1.) Post signs on the walls.

(2.) Include a section on protective eyewear in your employee training manual.

(3.) Have a copy of the warning on the sign-in card. This way it’s obvious that the customer had to review the consequences and hazards of their actions.

Remember, as a responsible tanning salon operator you must be committed to educating your staff and your clients about wearing protective eyewear.

FDA Requirements

If salon owners are keeping their eyes on their customers, than who’s keeping watch over the manufacturers? The answer is simple—the FDA.

The Code of Federal Regulations requires that the FDA inspect the manufacturing facility a minimum of once every two years.

During the inspection they look for adherence to GMP (Good Manufacture Practice) and all operations in accordance in Title 21 of Federal Regulations.

Regulations require that the manufacturer test every batch of his product for compliance. What specifically does the FDA look for? UV transmittance. The regulation requires that less than one-tenth of 1 percent of UVB and less than 1 percent of UVA is transmitted while still allowing enough visible light to pass through for vision.

Whether they like it or not, wearing protective eyewear is necessary for a client’s safety and health. But there is one other benefit to protective eyewear that salon owners don’t seem to recognize—profit.

The bottom line is that the salons that are asking their customers to buy protective eyewear are pulling in thousands of dollars a year. Especially when it’s sold as something the client needs to have for their own best health.

Protecting Your Employees

Last, but certainly not least, salon owners and service technicians need to wear protective eyewear when checking lamps and reading the meters on equipment. Protective eyewear is an issue that needs to be looked at seriously. Every salon has a responsibility to inform its customers of the health risks they’re taking every time they remove their protective eyewear. And the-customer cannot afford to turn a blind eye to the care and maintenance of their eyesight.

Protective Eyewear Care

As a tanning salon owner, you know everything in your salon requires some type of maintenance, from the tanning bed, right down to the carpeting. Making sure everything is in tip-top shape should be one of your main priorities. About the only thing that doesn’t require any maintenance is your protective eyewear, right? Wrong. Protective eyewear, as tiny an item as it may be, also requires continual upkeep.

One major issue that has recently been brought to light is the possibility that protective eyewear may not last forever, as was once thought. Therefore, it’s a good idea to replace eyewear every few months, depending on use.

FDA testing of protective eyewear is an ongoing process. Protective eyewear manufacturers are being monitored and checked for compliance continually. At this time, there is no data to prove that sun goggles wear out after a certain length of time. However, some speculate that because UV light does cause materials to deteriorate over time, salon owners should periodically replace goggles, just to be on the safe side.

Before bringing an eyewear line into your salon to sell, always make sure it is approved for use by the FDA. According to eyewear manufacturers, there are quite a few eyewear products floating around that are not. All protective eyewear should give some type of indication that it is compliant. If it doesn’t, don’t use it.

Some manufacturers claim their product blocks more than the required 99.9 percent of UVB, but it is difficult to determine whether this is true, because there are no instruments capable of monitoring that level of UV blockage. The amount is so minute that most laboratory instruments can’t measure it.

A major factor in the use and care of eyewear is proper fit. Too often, tanners discard the elastic bands that are provided with the goggles. They don’t seem to realize that these are part of the protective process. Connective bands are used to hold the glasses close to the eye so no UV light can seep in around the edges. Just placing the goggles over the eyes simply isn’t good enough. When clients purchase protective eyewear, tell them they must use the connective band.

Other forms of protective eyewear use thin, pliable wires across the nose bridge to hold them to the face. They can be adjusted to form the eyewear to the contours of the individual’s eyes and face.

Probably the greatest concern about eyewear, besides people not wearing it, is in regard to hygiene. There is nothing more unappealing to a tanner than going to put on goggles, only to find them smeared with mascara or make up. Of even greater concern, however, is the invisible, the threat of contracting a virus from someone who has worn the eyewear previously. Just the thought of such a possibility is enough to make a tanner throw the goggles aside.

The most commonly transmitted disease among tanners is pink-eye. This highly infectious disease is characterized by itching, redness, swelling and increased secretion. Needless to say, an epidemic of pink-eye in your salon could have a dramatic effect on your business.

Many salon owners are oblivious to the necessity of disinfecting eyewear and probably won’t realize its importance until an epidemic occurs in their salon. When cleaning the residue from glasses, make sure you choose a solution that is safe for use on plastic and something that won’t cause skin irritation. Make certain that goggles are thoroughly cleaned after each use. A half-done job simply isn’t acceptable when it comes to something as personal as eyewear. Protective eyewear should fit snugly around the eyeball. The tanner should not be able to see out the sides of the goggles.

Impetigo, viral or bacterial infections, cold sores and various other sores are also on the transferable disease list. Goggles must be disinfected between each use, not just a few times a day. Even if clients have their own pairs of goggles, they should continually clean them. The risk of infection comes not only from others, but also from oneself. If a client has some type of virus or infection and doesn’t clean his eyewear, he could very easily re-infect himself.

A co-itrinary disinfectant can be used for both cleaning and disinfecting. This type of disinfectant offers the largest range of virus-, bacteria- and fungus-killing properties. Alcohol can be used for disinfecting, but it is harsh on plastic. The disinfecting product you use will have instructions on the label. Follow them. Collect each pair of goggles immediately after they are used and clean them as instructed. Some disinfectants are sold in concentrated form and will have to be diluted with water. After the goggles have soaked for the manufacturer’s recommend time, they should be wiped or rubbed clean to remove visible deposits. Something that most people fail to do is rinse the goggles of all disinfectant. Generally people don’t realize they are supposed to do this. After the goggles have been rinsed, they should be dried thoroughly.

You may choose to disinfect a number of goggles at a time by placing them in a container filled with solution. On the average, most solutions are effective for a limited length of time. The best bet is to change the solution every day. Disinfectants are not expensive, so there really is no reason not to change it everyday.

The importance of wearing goggles while tanning can never be stressed enough. Despite the continual reminder that UV damages unprotected eyes, many tanners continue to let their own vanity rule. People still risk damaging their eyes just to eliminate tan lines.

We’ve discussed some potential hazards and conditions resulting from tanning without eye protection and tanning with contaminated eyewear, including pinkeye, impetigo, viral or bacterial infections, cold sores, corneal burns and brunescent cataracts.

The following discusses other eye diseases that can creep into your tanning salon and have a dramatic, negative impact on your business. By understanding their symptoms and indicators you can identify these types of infections quickly.

Molluscum Contagiosum 

This superficial skin infection is caused by a poxvirus. Close physical contact usually is necessary for transmission; however, indirect transmission from shared towels, eyewear and swimming pools can cause contact with the infection.

The incubation period varies from several weeks to several months, and symptoms include small, discrete, round pearly white growths on the skin. Common sites of the infection are the eyelids, neck, trunk and anogenital areas. The growths can measure between 2-5 mm and their sunken centers contain a white, curdy-type material. The bumps often remain unchanged for many months, after which they disappear; however, shaving or scratching may cause the infection to spread.

Blepharitis 

Blepharitis is a chronic inflammation of the eyelids that causes swelling, itching and irritation. There are two types— seborrheic and staphylococcus—which are common in both children and adults.

Seborrheic blepharitis is associated with dandruff of the scalp and may be part of an overall skin disease that also affects the chest, back and behind the ears. The condition is characterized by redness of the eyelids and scaling and flaking around the eyelashes. The glands of the eyelids produce an abnormal quantity and quality of tear film that causes the formation of greasy, waxy scales, which accumulate at the base of the eyelashes and flake off easily. Several factors including hormones, nutrition, general physical condition and stress may contribute to the development of this condition.

Staph blepharitis is a more severe condition that often begins in childhood and continues through adulthood. Staph blepharitis is caused by bacteria staphylococcus aureus, and it is characterized by matted, hard crusts around the eyelashes. The crust can make opening the eyes in the morning difficult.

Removal of the crusts often leaves small ulcers, which bleed or ooze. In some cases, a red eye may develop or a sty may form and a loss of lashes or broken lashes can occur. If left untreated, staph blepharitis may lead to infection and scarring of the cornea and other areas of the eye.

Herpes 

Herpes simplex virus (HSV) infections involving the eyelid can present in one of two forms. The classic appearance involves an accumulation of small vesicles or pustules along the lid margin and/or periocular skin. These lesions typically have an inflamed, erythematous base. Within the first week of infection, the vesicles may ulcerate or harden into crusts.

A second “erosive-ulcerative” form of HSV blepharitis presents itself with erosions of the lid at the Gray line or ulcers along the lid margin, or a combination of both. Typically, the lid displays generalized swelling and redness associated with these lesions. Symptoms include pain and tenderness upon touch, as well as increased lacrimation in severe cases. If the conjunctiva is involved, tarsal follicles may be observed along with bulbar injection and chemosis. Swollen pre-auricular nodes on the involved side are common.

The herpes virus, which causes cold sores, also can infect the membranes of the eye. Herpes simplex keratitis causes inflammation of the white of the eye and can damage the cornea. Herpes infection in the eye can cause corneal scarring with vision loss.

Signs and symptoms include pain, red eye, tearing, light sensitivity, irritation, scratchiness and decreased vision.

Protective Measures 

Now that you’ve increased your medical knowledge, there are a number of things you can do to curb the risk of one of these diseases overtaking your salon.

The first and most obvious is to educate your staff about the importance of providing clean, sanitized protective eyewear to each and every tanner. FDA regulations require that not only must there be signs posted on the equipment, but salon owners also must explain the proper use of protective eyewear to every customer. Failure to comply puts the owner at risk of being held liable in professional liability lawsuits.

Additionally, Texas is the only state that requires tanning salons to offer the eyewear at no charge. Therefore, salons that suggest their customers buy their own set of protective eyewear can increase their profits—especially when they are being sold as an accessory clients need to preserve their own personal health.

However, just because some tanners may have their own pair of goggles, they still need to clean them. Heat from the tanning bed can build up the bacteria in the goggle over time. Additionally, goggles should be kept in a sanitary container.

This is one obvious benefit of disposable eyewear—no chance for infection. Disposable eyewear is completely sanitary because the tanner is just wearing it once and then throwing it in the trash.

Whether the salon provides free disposable eyewear or goggles, some salons are encouraging clients to purchase their own set of goggles each and every time they tan.

The issue of eyewear is as important as any in the tanning equation. Whether your salon offers goggles or disposables, you must make it your mission to educate your staff and customers about the necessity of wearing clean, protective eyewear each and every time they tan.