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.
Section BB.11 Denial, Suspension Or Revocation Of Certificate Of Registration
(a) The Agency may, for good cause shown, deny, suspend or revoke a certificate of registration sought or issued pursuant to these regulations for any of the following reasons:
(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.
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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 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 products 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. |
(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.]
