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Questions and Answers

A B C D E F G H I J,K L M N O P Q R S T U V W X Y,Z

A     

 
B


C  Consumer Statement  


D   Defibrillator


E    Eyewear

      Exposure Schedules


F   
Federal Standard Title 21,


G    Going Out of Business


H


I   


JK


L   
Lamp Compatibility

       Lamp Disposal    

       Lamp Type Label

       Laser Light Show

      
M


N


O


P    Pacemaker

      Pregnant Consumer


Q


R   Registration

      Changes in Registration

      New Registration

      Expired Certificate of Registration


S    Selling a Business or Tanning Equipment


T    Termination

       Timers

       Training and Training Certificates


U


V


W


X


YZ

 

                                                                                                                                                                   

Consumer Statement

Topic: Consumer Statement

Rule: .1418(a)  Prior to initial exposure, the tanning facility operator shall provide each consumer the opportunity to read a copy of the warning specified in Rule .1414(b) of this Section and request that the consumer sign a statement that the information has been read and understood.  For illiterate or visually impaired persons unable to sign their name, the warning statement shall be read by the operator, in the presence of a witness, and the witness and the operator shall sign the statement.

Question:  Must all consumers sign a statement before each tanning session?

Answer:  All consumers must sign a consumer statement indicating that they have read and understand all warnings. 

 

Defibrillator

Topic:  Defibrillator

Rule:  The NC Radiation Protection Regulations do not prohibit tanning if you have a defibrillator or pacemaker.

Question:  Can you still tan if you have a defibrillator or pacemaker?

Answer:  Tanning units emit UVA and a small percentage of UVB.  These unit are electrical units with many electrical components including ballasts, boosters, fans, motors and many other parts.  Your health is critical and it is always recommended that you consult with your physician if you have conditions that concern you with regards to tanning. 

 

Eyewear

Topic: Protective Eyewear

Rule:  .1417(a)  The registrant shall provide protective eyewear to each consumer for use during any use of tanning equipment. 

Question:  Who is responsible for providing FDA compliant eyewear? 

Answer:  In accordance with NC and Federal regulations, registrants are responsible for providing FDA compliant eyewear.

 

Topic: Protective Eyewear

Rule:  .1417(b)  The protective eyewear in Paragraph (a) of this Rule shall meet the requirements of 21 CFR Part 1040, Section 1040.20(c)(4)

Question:  Do strings have to be worn?

Answer:  For your protection the manufacturer’s instructions state your eyewear must be worn and the strings must be attached while the client is tanning if the eyewear is manufactured to be worn with strings.

 

Exposure Schedules

Topic: Exposure Schedules According to Skin Types

Rule: .1415(a) The registrant shall use only tanning equipment manufactured in accordance with the specifications set forth in 21 Code of Federal Regulation (CFR) Part 1040, Section 1040.20, “Sunlamp products and ultraviolet lamps intended for  use in sunlamp product”.  The standard of compliance shall be the standards in effect at the time of manufacture as shown on the equipment identification label required by 21 CFR Part 1010, Section 1010.3

21 CFR 1040.20(d)(1)(vi): (1)  Labels for sunlamp products.  Each sunlamp product shall have a label(s) which contains: (iv) A recommended exposure schedule including duration and spacing of sequential exposures and maximum exposure time(s) in minutes.

21 CFR 1010.3(a):  Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section.  This information shall be provided in the form of a tag or label permanently affixed or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the applicable standard.  Except for foreign equivalent abbreviations as authorized in paragraph (a)(1) of this section all such labels or tags shall be in the English language. (1) The full name and address of the manufacturer of the product; abbreviations such as “Co.,” “Inc.,” or their foreign equivalents and the first and middle initials of individuals may be used…(2) The place and month and year of manufacture: (i) The place of manufacture may be expressed in code provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health with the key to such code.  (ii) The month and year of manufacture shall be provided clearly and legibly, without abbreviation, and with the year shown as a four-digit number.

Question:  What if a client insists on exceeding the exposure duration recommended by the certified operator?

Answer:  Comprehensive, written skin typing questions will enable you to accurately choose exposure durations for the most desirable cosmetic results sample skin typing questions and laminated examples of skin types are available online and through your service provider.

                                                                                                                                                                                                                                                             

Federal Standard Title 21
Rule:  .0117(a)(4) - Incorporation by reference

Question: 
The manufacturers I am looking at have told me their equipment complies with the "federal standard established in Title 21 the code of federal regulation section 1020."  Does this mean anything in NC?

Answer:  Yes, you do have to comply with the federal rules, standards and other requirements; this is incorporated into the North Carolina regulations by reference.

 

Going Out of Business (see Termination)

 

Lamp Compatibility

Topic: Lamp Compatibility

Rule:  .1418(f)  The registrant shall replace defective or burned out lamps, bulbs, or filters with a type intended for use in the affected tanning equipment as specified by the manufacturer’s product label and having the same spectral distribution (certified equivalent lamp).

Question:  How can I be sure the lamps I purchased are compatible with my equipment?

Answer:  When ordering new lamps or replacement lamps, always refer to the original lamp type label on your unit.  The Lamp Type label is located in the same area as the Danger Statement on your tanning unit.  The Lamp Type label can also be found in your manufacturer’s manual.  Tell your service provider what lamp type your label requires and ask them to send you proof of compatibility or (User Instructions) prior to shipment.  Lamps must show direct compatibility to the lamp type for your unit.  Your service provider can answer any questions you have regarding lamp compatibility and correct documentation.  Our agency can also assist with questions and concerns regarding lamp compatibility. 

Reading a User Instruction Guide Example:

Original Lamp (the lamp listed on your Unit)

Replacement Lamp

TanMe F71 T12 100W             →

                                                  →

                                                  →

SunMe F71 T12 100W

SunYou F71 T12 100W

SunMePlus F71 T12 100W

 TanMe F73 T12 100W           →

                                                  →

                                                  →

SunMe F73 T12 100W

SunYou F73 T12 100W

SunMePlus F73 T12 100W

If your Lamp Type label on your equipment was TanMe F71 T12 100W you would only be able to use the information directly across from the TanMe F71’s listed.

 

Lamp Disposal

Topic:  Lamp Disposal

Rule:  The NC Radiation Protection Section does not regulate lamp disposal.

Question:  How do I properly dispose of my lamps?

Answer:  Contact the Division of Waste Management, Technical Assistance Unit.

                Lebeed Kady (919) 508 - 8546 or lebeed.kady@ncdenr.gov

 

Lamp Type Label

Topic: Lamp Type Label

Rule:  .1415(a)  The registrant shall use only tanning equipment manufactured in accordance with the specifications set forth in 21 Code of Federal Regulation (CFR) Part 1040, Section 1040.20, “Sunlamp products and ultraviolet lamps intended for  use in sunlamp product”.  The standard of compliance shall be the standards in effect at the time of manufacture as shown on the equipment identification label required by 21 CFR Part 1010, Section 1010.3

21 CFR 1040.20(d)(1)(vi): (1)  Labels for sunlamp products.  Each sunlamp product shall have a label(s) which contains: (vi) Designation of the ultraviolet lamp type to be used in the product.

21 CFR 1010.3(a):  Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section.  This information shall be provided in the form of a tag or label permanently affixed or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the applicable standard.  Except for foreign equivalent abbreviations as authorized in paragraph (a)(1) of this section all such labels or tags shall be in the English language. (1) The full name and address of the manufacturer of the product; abbreviations such as “Co.,” “Inc.,” or their foreign equivalents and the first and middle initials of individuals may be used…(2) The place and month and year of manufacture: (i) The place of manufacture may be expressed in code provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health with the key to such code.  (ii) The month and year of manufacture shall be provided clearly and legibly, without abbreviation, and with the year shown as a four-digit number as follows:

Question:  What if my lamp type label is missing?

Answer:  Federal law requires that each unit of tanning equipment have a designated ultraviolet lamp type label affixed to the unit.  The lamp type label information is printed in the manufacturer’s manual for the unit.  If your labeling fades or become illegible, it must be replaced and it is your responsibility to replace the label.  Contact your service provider for the correct labeling for your unit.

 

Laser Light Shows                                                                                                                                       

RULE:  FDA 21 CFR 1010.4 and 21 CFR 1040.10

Question:  What correspondence must be provided to RPS when a laser light show will be directed or performed in NC?

ANSWER: All companies that provide this service are required to notify the RPS of laser light shows in accordance with the FDA standard.  The FDA standard stipulates the notification process.   These notifications should be faxed to RPS prior to the event.  We do not dictate what should be on the notification because this is determined by the FDA.

We do not have any rules or regulations regarding lasers.  However, these notifications are provided in case there is an injury.  These notifications should be sent to the Tanning Manager since this is a non ionizing application. 

The Notification must have at least the FDA Variance number, date issued, date of expiration, the event, the event venue with times and dates and Laser Company Information.

The notification should  also include Name of Laser Company, Company Address, FDA Docket , Accession number, Event, Venue, Time and Date, Laser Safety Officer (LSO), LSO telephone number, Agencies Notified, Description of Safety Factors, Laser Equipment, Show Effects, Schematic

 

Pacemaker - See Defibrillator

 

Pregnant Consumer

Topic: Pregnant Consumer

Rule:  The NC Radiation Protection Regulations do not prohibit pregnant consumers from tanning.

Question:  Can I allow pregnant consumers tan in my tanning bed?

Answer:  Tanning units emit UVA, a small percentage of UVB and may produce different degrees of heat.  The health of each consumer is critical and it is always recommended that they consult with their physician if they have conditions that concern them with regards to tanning.   

 

Registration - Change of Registration, New Registration, Expired Certificate of Registration

Topic: Changes in Registration

Rule:  .1409  The registrant shall notify the agency in writing within 30 calendar days after making any change which would render the information contained in the application for registration or the certificate of registration no longer accurate.

Question:  What should I do if I add or delete units?

Answer:  Changes in registration must be reported, in writing, within 30 days.  An amendment form was included in your initial registration packet, it is also available on-line and is included with your invoicing information.

 
Topic: 
New Registration

Rule:  .1405(a) Each person having a tanning facility on the effective date of this Rule shall apply for registration of such facility no later than 60 days following the effective date of this Rule. (b)  Each person acquiring or establishing a tanning facility after the effective date of this Rule shall have a certificate of registration issued by the agency for such facility prior to beginning operation. 

Question:  What documents do I have to submit in order to receive my new certificate of registration?

Answer:  All new facilities must submit a completed application of registration, payment for the annual fee, and certificates of training for all operators of the tanning equipment.  These same conditions apply if the facility has changed ownership.  If an inspector discovers a facility that has changed ownership or is operating without a certificate of registration, they must complete the application, provide the inspector with payment for the annual fee, and provide the inspector with all of the training certificates of the persons who operate the tanning equipment.  If they do not or if they are unable to meet all of these conditions they will be cited the appropriated violations and they will not receive a new certificate of registration.

 

Topic: Expired Certificate of Registration

Rule:  .1407  Except as provided in Rule .1408(b) of this Section, each certificate of registration shall expire at midnight on the expiration date stated therein.

Question:  When does my registration expire?

Answer:  Registration certificates are issued annually and expire on August 29th of each year.  You will receive renewal/amendment information in the mail prior to this date.  Your account will be delinquent if not paid and renewed or if necessary termination paperwork is not submitted.

 

Selling a Business or Tanning Equipment 

Topic: Selling a Business or Tanning Equipment

Rule:  .1412(d) The agency may terminate a certificate of registration upon receipt of a written request for termination from the registrant.

Question:  What if I sell my business or my units?

Answer:  If you cease to offer tanning services; you must notify the Section in writing.  Please provide the name and address of individuals to whom you sold the tanning equipment.  A request for termination form was included in your initial registration packet and is also available at our website at http://www.ncradiation.net

Related Topics Termination

 

Termination

Topic: Termination

Rule:  .1412(d) The agency may terminate a certificate of registration upon receipt of a written request for termination from the registrant.

Question:  What do I do if I close my business?

Answer:  If you are closing your business you are required to submit an affidavit of your intent to no longer offer tanning services.  “Seasonal business: are not exempt from yearly fees.  You can visit our website at  http://www.ncradiation.net to print out a termination affidavit.

 

Timers

Topic: Remote Timers

Rule:  .1415(i)  The timer for the tanning devices shall be remotely located outside the room where the tanning equipment is located.  The remote timer shall be set by a certified tanning operator.  Effective August 1, 2004, all tanning facilities shall be equipped with remote timers.

Question:  Does my timer have to be activated outside the tanning room(s).

Answer:  Effective 2004 all tanning equipment must be installed with timers outside of the tanning room(s).  Only a certified operator may set the timer.

 

Training
 

Topic: Training and Training Certificates

Rule:  .1418(h)   The registrant shall certify that all tanning equipment operators are trained in at least the following: (1) the requirement of this Section; (2) procedures for correct operation of the tanning facility and tanning equipment; (3) recognition of injury or overexposure to ultraviolet radiation; (4) the tanning equipment manufacturer’s procedures for operation and maintenance of the tanning equipment; (5) the determination of skin type of customers and appropriate determination of duration of exposure to registered tanning equipment; and (6) emergency procedures to be followed in case of injury.

Question:  Does my training certificate expire?

Answer:  No.  However, if you have lost or misplaced your tanning certificate, you can contact your tanning operator trainer for a duplicate copy.