216 R.I. Code R. 216-RICR-40-10-24.6

Current through December 26, 2024

Section 216-RICR-40-10-24.6 - Protection of Patrons

24.6.1Warning Statement

A. At each patron's initial visit to a tanning facility, and at intervals not to exceed twelve (12) months thereafter, the patron shall be provided a written statement containing the following information to review and sign:

1. Not wearing protective eyewear while tanning may cause injury to the eyes;

2. Overexposure to the tanning process may cause burns;

3. Repeated exposure to the tanning process may cause skin cancer or premature aging of the skin or both;

4. Abnormal skin sensitivity or burning may result from the tanning process if the patron is also consuming or using certain:

a. Foods;

b. Cosmetics; or

c. Medications, such as tranquilizers, antibiotics, diuretics, high blood pressure medication, antineoplastic or birth control pills.

5. Any person taking a prescription or over-the-counter drug should consult a physician or a registered pharmacist before using a sunlamp product; and

6. During pregnancy, a woman should consult with her health care provider before tanning.

B. A copy of this signed statement shall be maintained in the patron's record, as described in §24.8.3 of this Part.

C. The registrant shall be responsible for complying with the requirements of §24.6.1 of this Part.

24.6.2Warning Sign

A. Pursuant to R.I. Gen. Laws § 23-68-4(4), the registrant shall conspicuously post the warning sign described in §24.6.2(B) of this Part within one (1) meter (39.37 inches) of each sunlamp product and in such a manner that the sign is clearly visible, not obstructed by any barrier, equipment or other object, and can be easily viewed by the patron before operating the sunlamp product.

1. A similar sign containing at least the information listed in §24.6.2(B) of this Part that complies with all other applicable state and federal laws, codes and regulations may be used instead

DANGER - Ultraviolet Radiation Follow instructions Avoid overexposure As with natural sunlight, overexposure may cause eye and skin injury and allergic reactions. Repeated overexposure may cause premature aging of the skin and skin cancer. WEAR FDA COMPLIANT PROTECTIVE EYEWEAR. FAILURE TO USE PROTECTIVE EYEWEAR MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult a 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. If you believe that you have been injured by this tanning equipment, you should contact RI Department of Health, Radiation Control Program, 3 Capitol Hill, Room 305, Providence, RI 02908-5097 (401) 222-2566 or ofr@health.ri.gov

B. This warning sign shall use upper and lower-case letters which are at least ten millimeters (0.39 inches) and five millimeters (0.20 inches) in height, as follows:

1. Pursuant to 21 C.F.R. § 878.4635(b)(6)(i)(A), the warning sign required by §24.6.2(B) of this Part shall also include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years.

24.6.3Protective Eyewear

A. The registrant shall require that each patron wear protective eyewear during the use of sunlamp products.

1. The registrant shall provide such protective eyewear, unless the patron furnishes his or her own protective eyewear which meets the requirements of this Part.

2. Tanning facility operators shall instruct the consumer in the proper utilization of the protective eyewear required by §24.6.3 of this Part.

B. The tanning facility registrant shall ensure that patrons have the protective eyewear required by §24.6.3 of this Part before each tanning session and shall make a reasonable effort to ensure that this eyewear is worn during tanning.

C. The protective eyewear required by §24.6.3 of this Part shall meet the requirements of 21 C.F.R. § 1040.20(c)(4).

D. Any reusable protective eyewear furnished by the registrant shall be sanitized in accordance with §24.7.1(B) of this Part.

24.6.4Policy and Procedural Requirements Related to Patron Safety

A. The registrant shall maintain a list of the common photosensitizing agents as provided by the FDA, or other appropriate authorities, available for review by patrons.

B. At each tanning facility, the registrant shall keep a list of emergency contact numbers appropriate for the community in which the facility is located. This list shall be easily accessible and shall include, but not be limited to, contact numbers for:

1. The nearest hospital;

2. The nearest fire department; and

3. Emergency 911 service.

C. At least one (1) trained staff member is required on-site at all times when the tanning facility is in operation.

D. Only one (1) patron may be in a tanning room at one (1) time, with the following exceptions:

1. If two (2) or more sunlamp products are used in the same room, in which case only those patrons using sunlamp products may be present in the room; and

2. If a patron using a sunlamp product needs aid or assistance from another person, in which case that individual shall also be provided with and wear protective eyewear.

E. Exposure of Minors

1. No patron under the age of eighteen (18) shall be allowed to use a sunlamp product.

2. Infants and other minors are not permitted to be in the sunlamp product room during exposure of parents or guardians.

F. Exposure Limits and Other Controls against Overexposure

1. The registrant shall ensure that each patron using a sunlamp product shall be instructed on the maximum exposure time and proper exposure distance, as recommended by the manufacturer of the product.

2. The registrant shall ensure that each patron does not exceed the maximum exposure time indicated by the sunlamp product manufacturer.

a. The registrant shall limit exposure time to the recommended maximum exposure time provided by the product manufacturer on the sunlamp product or in the product operating manual. The maximum exposure time recommended by the manufacturer of the product shall not be exceeded in any twenty-four (24)-hour period.

b. Initial tanning sessions (three (3) to five (5)) are limited to one (1) tanning session per forty-eight (48)-hour period or as recommended by the sunlamp product manufacturer, whichever is less frequent, to allow adequate time for melanin activation and transit to occur prior to subsequent exposures. Patrons shall be advised of the manufacturer's recommended exposure schedule as posted on the sunlamp product or listed in the operating manual for the product prior to the initial tanning sessions.

c. After the initial (three (3) to five (5)) tanning exposures, tanning sessions are limited to one (1) tanning session per twenty-four (24)-hour period or as recommended by the sunlamp product manufacturer, whichever is less frequent. Patrons shall be advised of the manufacturer's exposure schedule as posted on the sunlamp product or listed in the operating manual for the sunlamp product prior to tanning.

d. For patrons with annual tanning packages, package maximums shall not exceed the maximum amount of exposure recommended by the product manufacturer.

3. Tanning facilities are prohibited from controlling the use of sunlamp products with token timer control systems, in the absence of trained staff.

4. The registrant shall ensure that the patron is instructed as to the location and proper operation of the sunlamp product's emergency shut-off switch.

5. The registrant shall establish and use a procedure manual that will aid in the protection of the patron from excessive or unnecessary exposure to ultraviolet light.

a. This manual shall be specific to the facility and shall include at least documentation of the requirements detailed in this Part.

b. A copy of this manual shall be kept on-site and readily available at all times when the tanning facility is in operation.

c. This procedure manual may be developed as part of the training manual described in §24.8.2 of this Part, provided the above requirements are met.

216 R.I. Code R. 216-RICR-40-10-24.6