64E-28.001: Scope of Chapter Rules
64E-28.010: Operational Requirements for a Temporary Tattoo Establishment
64E-28.011: Standards of Practice for a Tattoo Artist or Guest Tattoo Artist
64E-28.002: Definitions
64E-28.003: Licensure Requirements for a Tattoo Artist
64E-28.004: Licensure Renewal Requirement for a Tattoo Artist
64E-28.005: Registration Requirements for a Guest Tattoo Artist
64E-28.007: Licensure Requirements for a Permanent Tattoo Establishment
64E-28.008: Licensure Requirements for a Temporary Tattoo Establishment
64E-28.009: Operational Requirements for a Tattoo Establishment
PURPOSE AND EFFECT: The purpose of the proposed rule is to implement the requirements for tattoo artists and tattoo establishments as specified in Sections 381.00771-.00791, F.S., which passed during the 2010 Legislative Session.
SUMMARY: This proposed rule chapter will provide the minimum standards relating to the practice of tattooing including definitions; licensure requirements for tattoo artists, guest tattoo artists, and establishments; educational requirements; operational requirements for tattoo establishments; standards of practice for a tattoo artists and guest tattoo artists; forms; and fee schedule.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:
The Agency has determined that this will have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has been prepared by the agency.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
RULEMAKING AUTHORITY: 381.00789 FS.
LAW IMPLEMENTED: 381.00771-381.00791 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Gina Vallone-Hood, Environmental Manager, Bureau of Community Environmental Health, 4052 Bald Cypress Way, Bin #A08, Tallahassee, Florida 32399-1710
THE FULL TEXT OF THE PROPOSED RULE IS:
64E-28.001 Scope of Chapter Rules.
These rules provide minimum standards relating to tattoo artists and tattoo establishments.
Rulemaking Authority 381.00789 FS. Law Implemented 381.00787, 381.00791 FS. History–New________.
64E-28.002 Definitions.
(1) Alcohol-based hand sanitizer – An antimicrobial skin sanitizer which contains a minimum concentration of at least 60% alcohol.
(2) Aseptic technique – Practices used by a tattoo artist to prevent cross contamination.
(3) Compromised package – A wet, torn, or stained package.
(4) Contaminated – means the presence of disease-causing organisms on inanimate objects or surfaces.
(5) Cross contamination – The act of spreading disease-causing organisms from one surface to another.
(6) Disinfect – The use of a product registered with the United States Environmental Protection Agency (USEPA) as a tuberculocidal disinfectant which results in the reduction in the number of disease-causing organisms on objects or surfaces, thereby rendering them safe for handling and use.
(7) Fixed – Incapable of being moved.
(8) Inactive license – A tattoo establishment or artist license which has not been renewed by October 1.
(9) Minor – An individual who is less than eighteen (18) years of age.
(10) Person – Any individual, partnership, corporation, association, or public body.
(11) Registered business name – The name under which a tattoo establishment operates.
(12) Registered agent for service of process – A person authorized by a tattoo establishment to receive legal notices for the establishment.
(13) Single-use – means products or items that are intended for one-time, one-person use and are disposed of after use on each customer, such as cotton swabs or balls, gauze pads, tissues or paper products, sanitary coverings, razors, instruments that pierce the skin, and protective gloves.
(14) Spore strip – A device used to monitor the sterilization process in a steam autoclave to ensure destruction of Geobacillus stearothermophilus spores.
(15) Sterilization – The use of a steam autoclave to destroy all forms of microbial life, including spores.
(16) Tattoo artist – A tattoo artist as defined in Section 381.00771, F.S., including an artist who performs cosmetic tattooing.
(17) Unobstructed access – A situation where an artist can wash their hands and return to the tattooing area without recontaminating their hands by handling an object such as a door knob.
Rulemaking Authority 381.00789 FS. Law Implemented 381.00789 FS. History–New________.
64E-28.003 Licensure Requirements for a Tattoo Artist.
(1) A tattoo artist seeking initial licensure shall:
(a) Submit a completed application for licensure to the department on form DH 4147. An application shall be considered complete if all of the information requested on the form is provided, along with the fee specified in Rule 64E-28.011, F.A.C., and the following documentation is attached:
1. A copy of a government issued photo identification confirming the applicant is at least 18 years of age.
2. Proof of having completed a department approved course on blood-borne pathogens and communicable diseases having achieved a minimum score of 70 percent on the course examination.
(b) Complete a department approved course, as described in subparagraph 2., within six months of the effective date of this chapter.
(2) A tattoo artist’s license is valid for one year, October 1 to September 30 of the following year.
(3) A tattoo artist seeking licensure renewal shall:
(a) Annually, submit a completed application for license renewal on Form DH 4147 by October 1.
1. An application shall be considered complete if all of the information requested on the form is provided, along with the fee specified in Rule 64E-28.011, F.A.C.
2. A license which has not been renewed by October 1 shall be deemed inactive on this day. If this day falls on a weekend or holiday, a tattoo artist license must be renewed on or before the first working day after October 1.
(b) Not perform tattooing without an active license.
(4) A tattoo artist license shall not be transferable from one person to another.
Rulemaking Authority 381.00789 FS. Law Implemented 381.00771, 381.00775, 381.00779, 381.00781 FS. History–New________.
64E-28.004 Registration Requirements for a Guest Tattoo Artist.
(1) A guest tattoo artist seeking registration by the department shall submit a completed application for registration to the department on Form DH 4150 at least fourteen (14) days prior to practicing tattooing in any licensed tattoo establishment or licensed temporary tattoo establishment. An application shall be considered complete if all of the information requested on the form is provided, along with the fee specified in Rule 64E-28.011, F.A.C., and the following documentation is attached:
(a) A copy of a government issued photo identification confirming the applicant is at least 18 years of age.
(b) Proof of an active license, registration, or certification in another jurisdiction.
(c) Proof of having completed a course on blood-borne pathogens and communicable diseases with having achieved a score of at least seventy per cent (70%) on the course examination covering the materials in the course in that jurisdiction, provided the course requirements, as determined by the department, are comparable to or exceed those in Sections 381.00775(2)(b)4.and 5., F.S. and Rule 64E-28.006, F.A.C.
(2) Should the department determine that the education course and examination requirements in another jurisdiction do not meet or exceed those in Section 381.0075(2)(b), F.S. and Rule 64E-28.006, F.A.C., the applicant must submit proof of successful completion of a department approved education course and proof of having achieved a score of at least seventy per cent (70%) on an examination covering the materials in the course.
(3) A guest tattoo artist’s license is valid for up to fourteen (14) consecutive days.
(4) A guest tattoo artist shall not perform tattooing without an active guest tattoo artist registration.
(5) A guest tattoo artist registration shall not be transferable from one person to another.
Rulemaking Authority 381.00789 FS. Law Implemented 381.00775 FS. History–New________.
64E-28.005 Licensure Requirements for a Tattoo Establishment.
(1) Licensure of a permanent tattoo establishment:
(a) Requires a completed application shall be submitted to the county health department on form DH 4151 prior to performing tattooing. An application shall be considered complete if all of the information requested on the form is provided, along with the fee specified in Rule 64E-28.011, F.A.C.
(b) A license for a tattoo establishment is valid for one year, beginning October 1 and ending September 30.
(c) A license which has not been renewed by October 1 shall be deemed inactive on this day. If this day falls on a weekend or holiday, a tattoo artist license must be renewed on or before the first working day after October 1.
(2) Licensure of a temporary tattoo establishment:
(a) Requires a completed application shall be submitted to the county health department on form DH 4151 at least thirty (30) days prior to performing tattooing. An application shall be considered complete if all of the information requested on the form is provided, along with the fee specified in Rule 64E-28.011, F.A.C.
(b) A license for a temporary tattoo establishment is valid for fourteen (14) consecutive days in conjunction with a convention or similar event.
(3) No tattooing shall be performed at an establishment that does not have an active license.
(4) A tattoo establishment license shall not be transferable from one location or person to another.
Rulemaking Authority 381.00789 FS. Law Implemented 381.00777 FS. History–New________.
64E-28.007 Operational Requirements for a Tattoo Establishment.
(1) Tattoo establishments shall have walls, a floor, and a ceiling. Floors and walls in the tattooing area and the area where items are cleaned and sterilized shall be constructed of easily cleanable materials. The entire establishment shall be maintained in clean condition and good repair.
(2) There shall not be a direct opening between a tattoo establishment and any building or portion of a building used as living or sleeping quarters. This shall be accomplished, at a minimum, by a solid floor to ceiling wall of separation.
(3) A tattoo establishment shall not be located in an area where food is prepared.
(4) Except for first-aid purposes, eating and drinking are prohibited in areas where tattooing is performed or where instruments and supplies are cleaned and stored.
(5) Water supplies shall comply with the provisions of Chapter 64E-8 or 62-550, F.A.C.
(6) Sewage disposal shall comply with the provisions of Chapter 64E-6 or 62-200, F.A.C.
(7) The establishment shall use effective measures to protect against the entrance, breeding, and presence of vermin, such as insects and rodents. Openings to the outside shall be protected by such means as self-closing doors, closed windows, or screening. If screening is used, it shall not be less than sixteen (16) mesh to the inch.
(8) Animals shall not be allowed in a tattoo establishment, except as provided under Section 413.08, F.S. Aquariums with fish shall be allowed in waiting rooms and non-procedural areas only.
(9) Each tattoo establishment shall have an artificial light source equivalent to at least one hundred (100) foot candles in the tattooing area and in the area where items are cleaned and sterilized.
(10) Restrooms shall be supplied with toilet tissue, a hand sink supplied with running water under pressure, liquid soap, a dispenser with single-use paper towels, and a waste receptacle. Signage shall be posted in the restroom to instruct employees that they must thoroughly wash their hands before returning to work.
(11) A handsink with unobstructed access shall be located within each tattoo area or centrally located within the overall workroom area, so that each tattoo artist has access to the handsink for handwashing.
(a) The handsink shall be supplied with running water under pressure, liquid soap, a dispenser with single-use paper towels, and a waste receptacle.
(b) A restroom handsink may be used as the handsink provided that it is located within the tattoo establishment and it meets the above stated requirements.
(12) At a minimum, contaminated, reusable items shall be cleaned manually in a sink, separate from the handsink(s), or mechanically in an ultrasonic machine prior to sterilization.
(a) If items are manually cleaned in a sink, the sink shall be deep enough to allow complete submersion of the items. Gloves shall be worn when manual cleaning is performed.
(b) If items are cleaned in an ultrasonic machine, the machine shall be used in accordance with the manufacturer’s instructions, which shall be available for review by the department at the time of inspection.
(c) After cleaning, items shall be rinsed and allowed to air dry or shall be dried with single-use paper towels prior to packaging for sterilization.
(d) If only individually packaged, pre-sterilized, single-use items are used in the establishment, the cleaning sink and ultrasonic machine requirements do not apply.
(13) A tattoo establishment shall have a steam autoclave for sterilizing instruments.
(a) The autoclave shall be used in accordance with the manufacturer’s instructions for packaging, loading, and processing items.
(b) The autoclave shall be maintained to ensure proper operation.
1. The autoclave shall be cleaned at the frequency recommended by the manufacturer and shall be serviced at least once a year or at the frequency recommended by the manufacturer.
2. A copy of the manufacturer’s instructions for operating, cleaning, and servicing the autoclave shall be maintained in the tattoo establishment and shall be available for review by the department at the time of an inspection.
(14) When using an autoclave, sterilization shall be verified through:
(a) A chemical indicator strip placed inside one packet in each load to monitor the sterilization procedure. The strip must indicate exposure to steam and the autoclave operating temperature.
(b) Testing with spore strips at a minimum frequency of every 40 hours of operation of the autoclave, but not less than on a quarterly basis.
1. Test results shall be confirmed by an independent laboratory.
2. In the event of positive results, the autoclave shall be immediately taken out of service and all unused items processed in the autoclave since the most recent negative test results shall be considered non-sterile.
3. While the autoclave remains out of service, tattooing may continue provided either another properly functioning autoclave is placed in service in the establishment or all single-use, pre-sterilized instruments are used.
4. When the improperly functioning autoclave has been restored to proper function, which shall be confirmed by follow-up testing, it may be placed back in service.
(15) Each tattoo establishment shall maintain autoclave sterilization records onsite. The records shall, at a minimum, include the following information:
(a) Autoclave log showing cumulative run time, quantity and types of items sterilized on a given date, and the date spore strip testing was conducted.
(b) Spore strip results provided by an independent laboratory.
(16) If only individually packaged, pre-sterilized, single-use items are used, an autoclave shall not be required nor the requirements specified in 12, 13, 14, and 15 of this section.
(17) Packages of sterile items, which are sterilized by the tattoo establishment, shall be labeled with the date of autoclaving. If any package has been compromised, the items shall be re-sterilized.
(a) Individually packaged, pre-sterilized, single-use items shall be sterilized with ethylene gas and shall be labeled with the expiration date by the manufacturer.
(b) If a package containing pre-sterilized, single-use items has been compromised, the contents shall be discarded.
(c) All packages of sterile items shall be stored in a clean, dry, covered container or in a clean, dry cabinet until just prior to use.
(18) Work chairs, tables, stands, cabinets, and counter tops shall have a smooth, non-porous, easily cleanable surface, and shall be cleaned and disinfected after each customer.
(19) If any liquid product is not in its original container, the container into which the product has been placed shall be labeled with the name of the product.
(20) Each tattoo establishment shall maintain the following records:
(a) Customer records, including parental consent;
(b) Autoclave sterilization records and maintenance records;
(c) Documentation identifying the method of sterilization utilized by the manufacturer if the information is not printed on the packaging of the item.
(d) The records stated in (a), (b), and (c) above shall be maintained for two years with those records for the current licensing period maintained onsite in the establishment and available for review by the department at the time of inspection.
(e) Personnel records of each tattoo artist who works in the establishment. The record shall contain the tattoo artist’s name, a copy of a government-issued photo identification, and the license number issued by the department. Personnel records shall be maintained for at least 2 years after an artist’s employment ends.
(21) A tattoo establishment shall allow the department to conduct, at a minimum, annual inspections for the purpose of assisting the establishment in achieving compliance with Section 381.00771, F.S., and these rules.
(22) Biomedical waste shall be managed in accordance with Section 381.0098, F.S., and Chapter 64E-16, F.A.C. Regular solid waste shall be collected, stored and disposed of in a manner and at a frequency that do not create a sanitary nuisance, as defined in Chapter 386, F.S.
(23) Tattoo establishments not in full compliance with the handsink and cleaning sink requirements on the effective date of this chapter shall have six months from the effective date of this chapter to comply with the requirements.
Rulemaking Authority 381.00789 FS. Law Implemented 381.00779 FS. History–New________.
64E-28.008 Operational Requirements for a Temporary Tattoo Establishment.
(1) A licensed temporary establishment shall meet the operational requirements set forth in Rule 64E-28.007, F.A.C., with the following exceptions.
(2) A temporary establishment shall have rigid perimeter walls, a rigid floor, and a rigid ceiling. Floors in the tattooing area and the area where items are cleaned and sterilized shall be constructed of easily cleanable materials. The entire establishment shall be maintained in clean condition and good repair.
(3) If any tattoo items are sterilized by an artist prior to a temporary event, spore test results confirmed by an independent laboratory, shall be available for review by the department at the time of inspection.
Rulemaking Authority 381.00789 FS. Law Implemented 381.00779 FS. History–New________.
64E-28.009 Standards of Practice for a Tattoo Artist or Guest Tattoo Artist.
(1) A tattoo artist shall ensure that a customer record is completed for each customer. The record shall, at a minimum, include the following:
(a) Name of tattoo artist.
(b) Customer’s name, age, and birthdate.
(c) Copy of the identification used to verify customer is at least eighteen (18) years of age.
(d) Description and location of tattoo on the customer’s body.
(e) Signature of the customer.
(f) Signature of the artist.
(2) Pursuant to Section 381.00787, F.S., a tattoo artist shall not tattoo the body of a minor less than sixteen (16) years of age.
(3) If tattooing a minor who is sixteen (16) or seventeen (17) years of age, a tattoo artist shall obtain the following documents in addition to the requirements of subsection (1):
(a) Copies of a government-issued photo identification for both the minor and for the parent or legal guardian of the minor. If the photo identification for the minor does not show a birth date, a copy of the minor’s birth certificate shall be provided.
(b) A signed and notarized consent by the minor’s parent or legal guardian on form DH 4146.
(4) Prior to or after performing a tattoo procedure on a customer, a tattoo artist shall provide information on aftercare to the customer, both verbally and in writing.
(5) Prior to setup for a tattoo procedure, a tattoo artist shall:
(a) Ensure that the skin area where a tattoo is to be applied is visibly healthy.
(b) Wash their hands thoroughly using liquid soap, rinse them, and dry them using single-use paper towels.
(6) Prior to performing a tattoo procedure, a tattoo artist shall cleanse the area of the skin where the tattoo will be placed using a using a clean, single-use paper towel or pad and a solution labeled as an antiseptic. The antiseptic solution shall be used in accordance with the manufacturer’s instructions.
(7) If hair is to be removed from the area to be tattooed, either a single-use razor shall be used, or clippers which are capable of being disinfected. If hair removal is done after cleansing, the area shall be re-cleansed as specified in subsection (6) above.
(8) While performing a tattoo procedure, a tattoo artist shall:
(a) Use aseptic techniques, including barrier covers.
(b) Use only sterile needle bars, sterile needle tubes, and single-use, sterile needles.
(c) Wear new, disposable examination gloves, which shall be discarded after the completion of each single tattooing session.
1. Should the gloves become torn, punctured, or otherwise contaminated outside the general scope of tattooing, or should the gloves come in contact with any object or surface other than the customer’s skin or items being used in the procedure, the gloves shall be removed and discarded and the tattoo artist shall thoroughly wash their hands or apply an alcohol-based hand sanitizer and re-glove before resuming the tattoo session.
2. In the event a tattoo artist must leave the tattooing area, the gloves shall be removed and discarded. The artist shall thoroughly wash their hands or apply an alcohol-based hand sanitizer and re-glove before resuming the tattoo session.
(d) Discard any sterile, single-use items that become contaminated and replace them with sterile items before resuming the procedure.
(e) Use a stencil that is single-use and clean. The product used to apply the stencil shall be packaged as a single dose or dispensed from a product container as a single customer dose.
(f) Any item used for freehand artistry on the customer shall be single-use and discarded after use unless an antiseptic is applied to the skin after marking the skin.
(g) Use inks, dyes, and pigments which are intended for tattooing.
1. Inks shall be used in accordance with the manufacturer’s instructions.
2. Individual portions of inks, dyes, or pigments shall be dispensed into clean single-use cups for each customer.
(9) Any item which an artist adds to a tattoo machine to stabilize the needle shall be either single-use or a reusable item that has been disinfected.
(10) Upon completion of a tattooing procedure, a tattoo artist shall:
(a) Remove any excess ink from the customer’s skin with a single-use clean paper towel or pad.
(b) Use a clean glove, single-use paper towel, or single-use pad to apply a moisturizing ointment or lotion that is packaged as a single dose or is dispensed from a product container as a single customer dose.
(c) If needed, cover the tattooed area with a clean nonstick bandage.
(d) Remove and discard any barriers used to cover instruments and equipment and disinfect both the tattoo machine and the work area with a tuberculocidal disinfectant registered with the USEPA.
(e) Remove any reusable instruments from the tattooing area in preparation for cleaning, rinsing, drying, and sterilization.
(f) Discard any unused ink, dye, or pigment.
(g) Thoroughly wash and rinse hands and dry them with clean single-use paper towels.
Rulemaking Authority 381.00789 FS. Law Implemented 381.00779 FS. History–New________.
64E-28.010 Forms.
(1) DH Form 4147, 03/12, Application for Tattoo Artist License.
(2) DH Form 4150, 03/12, Application for Guest Tattoo Artist Registration.
(3) DH Form 4151, 03/12, Application for Tattoo Establishment License.
(4) DH Form 4146, 03/12, Consent Form for Minor.
(5) DH Form 4154, 03/12, Tattoo Establishment Stop Use Order.
Rulemaking Authority 381.00789 FS. Law Implemented 381.00789, 381.00775(3)(a), 381.00777(2), 381.00775(4), 381.00787(2)(d) FS. History–New________.
64E-28.011 Fee Schedule.
(1) Tattoo Artist License and Renewal $ 60.00
(2) Guest Tattoo Artist Registration and Re-registration $ 35.00
(3) Tattoo Establishment License $200.00
(4) Temporary Establishment License $200.00
(5) Reactivation of Tattoo Artist License $ 25.00
(6) Reactivation of Tattoo Establishment License $ 75.00
Rulemaking Authority 381.00789 FS. Law Implemented 381.00781 FS. History–New________.