State Of TexasHealth and Safety Code
Texas
Administrative Code
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER V |
MINIMUM STANDARDS FOR LICENSURE OF
TATTOO AND CERTAIN BODY PIERCING STUDIOS |
| RULE §229.401 |
General Provisions |
(a) These sections provide for the licensing and regulation of tattoo
and certain body piercing studios and temporary locations.
(b) The "Tattoo and Certain Body Piercing Studio Act," Texas
Health and Safety Code, Chapter 146, requires the Texas Board of Health
to adopt rules regulating tattoo and certain body piercing studios and
temporary locations.
(c) No person may cause, suffer or allow the operation, management, or
maintenance of a tattoo and certain body piercing studio and temporary
location without a license issued in accordance with these sections.
(d) All tattoo and certain body piercing studios and temporary locations
shall comply with the minimum standards specified in these sections in
addition to the existing standards contained in the Tattoo and Certain
Body Piercing Studio Act and the Health and Safety Code, Chapter 431,
the Texas Food, Drug, and Cosmetic Act, relating to drugs, devices, and
cosmetics, including adulteration and misbranding.
(e) All tattoo and certain body piercing studios and temporary locations
should comply with applicable provisions of the Americans With
Disabilities Act.
Source Note: The provisions of this §229.401 adopted to be
effective April 23, 2000, 25 TexReg 3272
Texas
Administrative Code
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER V |
MINIMUM STANDARDS FOR LICENSURE OF
TATTOO AND CERTAIN BODY PIERCING STUDIOS |
| RULE §229.402 |
Definitions |
The following words and terms, when used in these sections, shall
have the following meanings, unless the context clearly indicates
otherwise.
(1) Act--The Tattoo and Certain Body Piercing Studio Act, Texas Health
and Safety Code, Chapter 146.
(2) Antiseptic--An agent that kills disease-causing microorganisms on
human skin or mucosa.
(3) Artist--A person who performs tattooing, intradermal cosmetics, and
or certain body piercing, and who is responsible for complying with the
provisions of these sections.
(4) Aseptic technique--A hygienic practice which prevents and hinders
the direct transfer of microorganisms, regardless of pathogenicity, from
one person or place to another person or place.
(5) Authorized agent--An employee of the department designated by the
commissioner to enforce the Act.
(6) Body piercer--A person who performs body piercing and who is
responsible for adherence to the provisions of these sections; hereafter
referred to as artist.
(7) Body piercing--The creation of an opening in an individual's body,
other than in an individual's earlobe, to insert jewelry or another
decoration.
(8) Body piercing studio--A permanent, nondwelling building or portion
of a building, designated by a license holder and located in accordance
with applicable local zoning codes where body piercing is performed,
completely separated from living quarters; hereafter referred to as
studio.
(9) Client--A person requesting the application of a tattoo or certain
body piercing.
(10) Commissioner--Commissioner of the Texas Department of Health.
(11) Contaminated waste--Any liquid or semi-liquid blood or other
potentially infectious materials; contaminated items that would release
blood or other potentially infectious materials in a liquid or
semi-liquid state if compressed; items that are caked with dried blood
or other potentially infectious materials and are capable of releasing
these materials during handling; contaminated sharps and pathological
and microbiological wastes containing blood and other potentially
infectious material, as defined in 29 Code of Federal Regulations, Part
1910.1030, known as "Occupational Exposure to Bloodborne
Pathogens". Copies of this provision are indexed and filed in the
office of the Drugs and Medical Devices Division, Texas Department of
Health, 1100 West 49th Street, Austin, Texas 78756, and are available
for inspection during normal working hours.
(12) Cosmetic--An article or substance intended to be rubbed, poured,
sprinkled, or sprayed on or introduced into or otherwise applied to the
human body for cleansing, beautifying, promoting attractiveness or
altering appearances; or an article or substance for use as a component
of such an article, except that the term does not include soap.
(13) Department--The Texas Department of Health.
(14) Disinfectant--An agent that kills disease-causing microorganisms on
inanimate objects or surfaces.
(15) Ear piercing--The creation of an opening in an individual's ear
lobe with an ear piercing gun to insert jewelry or other decoration.
(16) Ear piercing gun--A device that pierces an individual's ear using a
single-use stud and clasp ear piercing system. An ear piercing gun shall
not be used to pierce any other part of the body besides the ear.
(17) Germicidal solution--An agent that kills disease-causing
microorganisms on hard surfaces; a disinfectant or sanitizer registered
with the Environmental Protection Agency and or an approximate 1:100
dilution of household chlorine bleach (1/4 cup bleach and 1 gallon of
water).
(18) Germicidal soap--An agent designed for use on the skin that kills
disease-causing microorganisms, including but not limited to, products
containing povidone-iodine, chloroxylenol, triclosan, and chlorhexidine
gluconate.
(19) Hand washing facility--Sink equipped with hot and cold or tempered
running water under pressure, used for washing hands, arms, or other
portions of the body.
(20) Health care practitioner--A person licensed by the state to
practice medicine.
(21) Instruments--Hand pieces, needles, needle bars, hemostats, forceps,
pliers, and other items that may come in contact with a client's body or
possible exposure to bodily fluids during the tattoo and body piercing
procedures.
(22) Jewelry--Any personal ornament inserted into a pierced area, which
must be made of surgical implant grade stainless steel (minimum of 316L
or 316LVM), solid 14k or 18k gold, niobium, titanium (minimum of 6A14V),
or platinum, which is free of nicks, scratches, or irregular surfaces
and has been properly sterilized prior to use.
(23) License holder--A person who owns, operates, or maintains a tattoo
studio, tattoo and body piercing studio, body piercing studio or
temporary location in compliance with these sections.
(24) Managing conservator--A person, licensed child-placing agency, or
authorized agency designated by a court as having the right to
possession of the child, and the right to consent to medical, surgical,
dental, and psychological treatment of the child.
(25) Sanitize--To treat a clean surface and kill pathogenic
microorganisms.
(26) Sharps--Any object (sterile or contaminated) that may purposefully
or accidentally cut or penetrate the skin or mucosa including, but not
limited to, needles, scalpel blades, and razor blades.
(27) Sharps container--A puncture-resistant, leak-proof container that
can be closed for handling, storage, transportation, and disposal and
that is labeled with the International Biohazard Symbol.
(28) Single-use--Articles intended for one-time, one-person use and
which are to be discarded after such use.
(29) Sterilization area--A separate room or area separate from
workstations with restricted client access in which tattoo and body
piercing instruments are cleaned, disinfected, and sterilized.
(30) Tattoo/tattooing--The practice of producing an indelible mark or
figure on the human body by scarring or inserting a pigment under the
skin using needles, scalpels, or other related devices including
intradermal cosmetics.
(31) Tattoo and body piercing area--The portion of the tattoo or body
piercing studio used for applying tattoos or performing body piercing,
including all surrounding areas which are likely to come into contact
with contaminated waste.
(32) Tattooist--A person who performs tattooing or applies intradermal
cosmetics and who is responsible for adherence to the provisions of
these sections; hereafter referred to as artist.
(33) Tattoo studio--A permanent, nondwelling building or portion of a
building, designated by a license holder and located in accordance with
applicable local zoning codes where tattooing or intradermal cosmetic
application is performed, completely separated from living quarters;
hereafter referred to as studio.
(34) Temporary location--A fixed location at which tattooing or body
piercing is performed for a specified length of time of not more than
seven days in conjunction with a single event or celebration, where the
primary function of the event or celebration is tattooing or body
piercing.
(35) Universal precautions--A method of infection control in which
employees treat all blood and body fluids as to contain all bloodborne
pathogens and taking proper precautions to prevent the spread of any
bloodborne pathogens. Precautions include hand washing, gloving,
personal protective equipment, injury prevention, and proper handling
and disposal of needles, other sharp instruments, and blood and body
fluid contaminated products.
Source Note: The provisions of this §229.402 adopted to be
effective April 23, 2000, 25 TexReg 3272
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER V |
MINIMUM STANDARDS FOR LICENSURE OF
TATTOO AND CERTAIN BODY PIERCING STUDIOS |
| RULE §229.403 |
Licensing Fees, Procedures, and
Exemptions |
(a) License fees. All tattoo and body piercing studios shall obtain a
license annually except as indicated below from the Texas Department of
Health (department) and shall pay an annual, non-refundable license fee
for each place of business operated as follows:
(1) $450 per tattoo only studio or temporary location license for a
specified length of time not to exceed seven days;
(2) $600 for a tattoo and body piercing studio or temporary location
license for a specified length of time not to exceed seven days--the fee
to be paid as follows: $450 for the tattoo portion; and $150 for the
body piercing portion; and
(3) $200 per body piercing only studio or temporary location license for
a specified length of time not to exceed seven days.
(b) License forms. License forms may be obtained from the Drugs and
Medical Devices Division, Texas Department of Health, 1100 West 49th
Street, Austin, Texas, 78756-3182.
(c) License application. An application shall be submitted for each
tattoo studio and a separate application shall be submitted for each
body piercing studio. The initial license application for each studio or
temporary location shall be signed and verified, shall be made on the
license application furnished by the department, and shall contain the
following information:
(1) the full or legal name under which the studio or temporary location
is conducted;
(2) the address of the studio or temporary location that is to be
licensed. Sufficient descriptive information must be included if the
studio or temporary location is located in a portion of the building
with other license holders;
(3) if a proprietorship, the name and residence address of the
proprietor; if a partnership, the names and residence addresses of all
partners; if a corporation, the date and place of incorporation and name
and address of its registered agent in the state; or if any other type
of association, then the names of the principals of such association;
(4) for each studio or temporary location, the name(s) and residence
address(es) of the responsible individual(s) thereof;
(5) the name(s) of the studio's or temporary location's artist(s);
(6) the usual days and hours of operation of each studio or temporary
location; and
(7) a description of all services to be provided at the studio or
temporary location.
(d) Issuance of license. The department may issue a license to the owner
of a studio or temporary location after determining that the studio or
temporary location is in compliance with applicable statutes, rules, and
zoning codes.
(1) The initial studio license shall be valid for one year from the date
of issuance which becomes the anniversary date. The temporary location
license is valid for a specified period not to exceed seven days.
(2) The renewal studio license shall be valid for one year from the
anniversary date.
(3) The license shall be displayed in a prominent place in the studio or
temporary location.
(e) Renewal of license--applicable to studios only.
(1) Each year, the license holder shall renew its license in accordance
with the requirements of this section.
(2) The license holder shall renew the license by filing an application
for renewal on the form prescribed by the department accompanied by the
required licensure fee. A licensee must file for renewal before the
expiration date of the current license. A person who files a renewal
application after the expiration date must pay an additional $100 as a
delinquency fee.
(3) Failure to submit the renewal application annually shall subject the
studio to the enforcement provisions of the Tattoo and Certain Body
Piercing Studio Act and also to the provision of §229.412 of this title
(relating to Refusal, Revocation or Suspension of License and
Enforcement Provisions).
(A) Amendment of license. A license must be amended when the name,
ownership, or location of the licensed studio is changed. Such changes
require submission of the fees as outlined in subsection (a) of this
section.
(B) Notification of change of location of studio.
(i) Not fewer than 30 days in advance of the change, the licensee shall
notify the commissioner or the commissioner's designee in writing of the
licensee's intent to change the location of a licensed studio. The
notice shall include the address of the new location, and the name and
residence address of the individual in charge of the studio at the new
location.
(ii) Notice will be deemed adequate if the licensee provides the intent
and verification notices to the commissioner or the commissioner's
designee within the established time frames of clause (i) of this
subparagraph by certified mail, return receipt requested, mailed to the
Drugs and Medical Devices Division, Texas Department of Health, 1100
West 49th Street, Austin, Texas, 78756.
(iii) Not later than the tenth day after the change of location is
complete, the license holder shall notify the department in writing and
shall verify the information submitted under clause (i) of this
subparagraph.
(f) Exemption from licensure. Persons who engage only in the following
are exempt from the licensing requirements of this section:
(1) a studio or temporary location located within a medical facility
which is licensed under other law, or an office or clinic of a person
licensed by the Texas State Board of Medical Examiners;
(2) a person who performs only ear piercing; or
(3) a facility in which only ear piercing is performed.
Source Note: The provisions of this §229.403 adopted to be
effective April 23, 2000, 25 TexReg 3272
RULE §229.404
Physical Facilities
(a) A studio must be in a permanent, nondwelling building or portion of
a building which must be in a location which is permissible under local
zoning codes, if any. The studio shall be separated from living quarters
by complete floor to ceiling partitioning and shall contain no access to
living quarters.
(b) The studio or temporary location shall be maintained in a sanitary
condition.
(1) Work surfaces shall be cleaned and sanitized with a germicide
solution.
(2) Other environmental surfaces shall be cleaned with an all-purpose
detergent disinfectant.
(c) The walls, ceilings, and floors shall be kept in good repair. The
tattoo and body piercing area shall be constructed of smooth, hard,
surfaces that are non-porous, free of open holes or cracks, light
colored, and easily cleaned. New studios shall not include dark-colored
surfaces in the tattoo and body piercing area. Existing studios with
dark-colored surfaces in the tattoo and body piercing area shall replace
the dark-colored surfaces with light-colored surfaces whenever the
facilities are extensively remodeled.
(d) Studios or temporary locations shall have adequate lighting of at
least 50 foot candles of illumination in the tattooing, body piercing,
and sterilization area.
(e) Adequate mechanical ventilation shall be provided in the studio.
(f) Each studio or temporary location shall be equipped with
hand-washing facilities for its personnel with unobstructed access to
the tattoo and body piercing area such that artists can return to the
area without having to touch anything with their hands. Hand-washing
facilities shall be equipped with hot and cold or tempered running water
under pressure; liquid germicidal soap; single-use towels or other
approved hand-drying devices; and a covered refuse container. Such
facilities shall be kept clean and in good repair.
(g) Animals are not permitted in the studios or temporary locations,
except for guide or service animals accompanying persons with
disabilities, or nonmammalian animals in enclosed glass containers such
as fish aquariums, which shall be outside the tattooing, body piercing,
and sterilization area.
(h) Use of tobacco products shall be prohibited in the tattoo, body
piercing, and sterilization area. Consumption of alcoholic beverages
shall be prohibited in the studio or temporary location.
(i) The studio or temporary location shall be kept free of rodents and
vermin and protected from infestation by insects.
(j) If tattooing or body piercing is performed where cosmetology
services are provided, it shall be performed in an area that is separate
and enclosed.
Source Note: The provisions of this §229.404 adopted to be
effective April 23, 2000, 25 TexReg 3272
RULE §229.405
Personnel Responsibilities
(a) All artists while tattooing or body piercing shall wear clean outer
garments, maintain a high degree of personal cleanliness, and conform to
hygienic practices while on duty.
(b) All artists shall wash their hands thoroughly using hot or tempered
water with a liquid germicidal soap before and after tattooing or body
piercing and as often as necessary to remove contaminants.
(c) All artists must wear single-use examination gloves while assembling
tattooing and body piercing instruments and while tattooing and body
piercing.
(d) When a session is interrupted or immediately after gloves are torn
or perforated:
(1) gloves shall be removed and discarded; and
(2) hands shall be washed and a fresh pair of gloves used.
(e) Artists shall use universal precautions while tattooing or body
piercing. An artist diagnosed with a communicable disease shall provide
to the department a written statement from a health care practitioner
that the artist's condition no longer poses a threat to public health.
(f) The area of the client's skin to be tattooed shall be cleaned with
an approved germicidal soap according to label directions.
(g) The external skin of the client to be pierced shall be cleaned with
an approved germicidal soap according to label directions. In the case
of oral piercings, the operator shall provide the individual with
antiseptic mouthwash in a single-use cup and shall ensure that the
individual utilizes the mouthwash provided. In the case of a lip,
labret, or cheek piercing, procedures described in this paragraph for
both skin and oral piercings shall be followed.
(h) If shaving is required, razors shall be single-use.
(i) Each artist performing any tattoo or body piercing procedure in the
studio or temporary location, shall have the education, training and
experience, or any combination thereof, to practice aseptic technique
and prevent the transmission of bloodborne pathogens. All procedures
shall be performed using aseptic technique.
Source Note: The provisions of this §229.405 adopted to be
effective April 23, 2000, 25 TexReg 3272
RULE §229.406
Client Qualifications,
Disclosure, and Records
(a) Except as permitted in subsections (c) and (d) of this section, a
client must be a minimum of 18 years of age and shall present at the
time of tattooing or body piercing a valid, government issued, positive
identification card including, but not limited to, a driver's license,
passport, or military identification. The identification must contain a
photograph of the individual and a printed date of birth.
(b) The artist shall verify and document in the permanent client record
the client's age, date of birth, and the type of identification
provided.
(c) An artist may not tattoo a person younger than 18 years of age
without consent from the individual's parent or guardian, who determines
it to be in the best interest of the minor child to cover an existing
tattoo.
(1) The existing tattoo must contain:
(A) obscene or offensive language or symbols;
(B) gang-related names, symbols, or markings;
(C) drug-related names, symbols, or pictures; or
(D) some other type of words, symbols or markings that the court
considers would be in the best interest of the minor to cover.
(2) The consent required by subsection (c) can be satisfied by:
(A) a written and notarized consent by the individual's parent or
guardian which shall contain:
(i) the full name, address, and telephone number of the client;
(ii) the full name, address, and telephone number of the parent or
guardian;
(iii) a detailed description or photograph of the tattoo to be covered;
(iv) the location on the body of the tattoo to be covered; and
(v) the signatures of minor and parent or guardian; or
(B) the individual's parent or guardian:
(i) being physically present at the time the tattooing is being
performed;
(ii) executing an affidavit stating that the person is the parent or
guardian of the individual on whom the tattooing is being performed;
(iii) presenting evidence of the minor's identity to the artist; and
(iv) presenting evidence of the status as parent or guardian of the
individual who will receive the tattoo to the artist.
(3) If a parent or guardian of the minor child and the minor child agree
to the covering of the tattoo as described in subsection (c)(1) of this
section, the artist may request the issuance of an order from a justice
court.
(4) If the parent or guardian and the minor child do not agree to the
covering of a tattoo by a artist, then an order must be issued by a
district court or other court with jurisdiction of a suit affecting the
parent-child relationship or a civil proceeding brought under Title 3 or
4 of the Texas Family Code before an artist may cover the minor child's
tattoo.
(d) An artist may not perform body piercing on a person younger than 18
years of age without the consent of a parent, managing conservator, or
guardian of the individual. The consent can be satisfied by:
(1) a written and notarized consent by the individual's parent, managing
conservator, or guardian which shall contain:
(A) the full name, address, and telephone number of the client;
(B) the full name, address, and telephone number of the parent, managing
conservator, or guardian;
(C) the location on the body that may be pierced; and
(D) the signatures of the minor and parent, managing conservator, or
guardian; or
(2) the individual's parent, managing conservator, or guardian:
(A) being physically present at the time the body piercing is being
performed;
(B) executing an affidavit stating that the person is the parent,
managing conservator, or guardian of the individual on whom the body
piercing is being performed;
(C) presenting evidence of the minor's identity to the artist; and
(D) presenting evidence of the status as parent, managing conservator,
or guardian of the individual who will receive the body piercing to the
artist.
(e) No person may be tattooed or body pierced who appears to be under
the influence of alcohol or drugs.
(f) Tattooing and body piercing shall not be performed on any skin
surface which manifests any evidence of unhealthy conditions such as
rashes, boils, infections, or abrasions.
(g) Before receiving a tattoo, each client shall be informed verbally
and in writing about the possible risk and dangers associated with the
application of each tattoo. These shall include, but are not limited to,
at least the following: the possibility of discomfort or pain; the
permanence of the markings; the risk of infection; and the possibility
of allergic reaction to the pigments or other materials used.
(h) Before receiving a body piercing, each client (and if applicable,
the parent, managing conservator, or guardian) shall be informed
verbally and in writing about the possible risks and dangers associated
with receiving a body piercing. These shall include, but are not limited
to, at least the following: the possibility of discomfort or pain; the
possibility of scarring; the possibility of bleeding; the possibility of
swelling; the risk of infection; the possibility of nerve damage; and
the increased risk for adolescents during certain stages of development.
(i) The studio or temporary location shall maintain proper records of
each client. The information shall be permanently recorded and made
available for examination by the authorized agent. Records shall be
maintained at the studio for at least two years following the date of
the last entry. The temporary location client records shall be
maintained by the license holder. These permanent records shall include
the following:
(1) the name, address, and telephone number of the client;
(2) the date tattooing or body piercing was performed;
(3) the client's age, date of birth, and type of positive identification
provided to the artist (this information is to be recorded by the artist
as described in subsection (b) of this section);
(4) the specific color or colors of the tattoo or type of jewelry used
for the piercing and, when available, the manufacturer's catalogue or
identification number of each color or type of jewelry used;
(5) the location on the body where the tattoo or body piercing was
performed;
(6) the name of the artist;
(7) a statement that the client has received a copy of applicable
written care instructions, and that the client has read and understands
the instructions; and
(8) the signature of the client.
Source Note: The provisions of this §229.406 adopted to be
effective April 23, 2000, 25 TexReg 3272
RULE §229.407
Sterilization
(a) A studio or temporary location is required to utilize instruments
that have been prepared as described in §229.409(a)-(c) of this title
(relating to Tattooing and Body Piercing Instruments and Jewelry). The
studio or temporary location shall use sterilization equipment that is
approved by the United States Food and Drug Administration for the
purpose of sterilization, and adequate in size to accommodate necessary
utensils and instruments. A copy of the manufacturer's recommended
procedures for operation of the sterilization unit(s) must be available
for inspection by an authorized agent.
(b) Each person responsible for the sterilization of instruments shall
be able to demonstrate to the department's authorized agent the correct
sterilization procedures and the proper operation of autoclave and/or
dry heat sterilization equipment.
(c) After each use, the reusable instruments shall be cleansed to remove
blood and tissue residue before sterilization as described in §229.409(n)
of this title.
(d) Instruments requiring sterilization shall be packed in packages
approved for the sterilization unit. Instruments shall be packed
individually, or as a set provided such set is intended to be used for a
single procedure. Each package shall be labeled with the date of
sterilization and the initials of the person sterilizing the
instruments. Packaged sterilized instruments shall be kept in a sterile
condition and stored in a clean dust-tight container when not in use.
(e) Each package of instruments sterilized shall be monitored for
sterilization by the use of chemical/heat sensitive indicators.
(f) Each studio or temporary location shall maintain sterilization
records. The information shall be permanently recorded and made
available for examination by an authorized agent in the studio for at
least two years from the date of the last entry. These permanent records
shall be maintained at the studio and shall include the following:
(1) date of sterilization;
(2) quantity and type of instruments to be sterilized; and
(3) name or initials of the individual sterilizing the instruments.
(g) Sterilized instruments stored in an approved manner and not used
within 30 days after sterilization shall no longer be considered sterile
and shall be resterilized before use, unless the studio or temporary
location utilizes presterilized instruments sterilized by the
manufacturer. If presterilized instruments are used, the artist shall
obtain documentation from the manufacturer that describes the method of
sterilization utilized by the manufacturer and the manufacturer's
recommendations for storage and maintenance of sterility. This
documentation shall be available for inspection by an authorized agent.
The artist shall follow the manufacturer's instructions for storage and
maintenance of sterility.
(h) One of the following methods of sterilization shall be used.
(1) Autoclave--steam under pressure:
(A) 121 degrees Celsius (250 degrees Fahrenheit) and a pressure of at
least 15 pounds per square inch for not less than 30 minutes after the
chamber of the autoclave has reached the required temperature and
pressure; or
(B) as specified in the manufacturer's operator's manual.
(2) Dry heat sterilization:
(A) 160 degrees Celsius (320 degrees Fahrenheit) for not less than one
hour under atmospheric pressure after the sterilizer has reached the
required temperature; or
(B) as specified in the manufacturer's operator's manual.
Source Note: The provisions of this §229.407 adopted to be
effective April 23, 2000, 25 TexReg 3272
RULE §229.408
Care of the New Tattoo and/or
Body Piercing
(a) Each time tattooing or body piercing is performed the client (and if
applicable, the parent, managing conservator, or guardian) shall receive
oral and written instructions on the care of the area tattooed or
pierced. The client shall sign a written statement in the permanent
client record acknowledging that the client has received a copy of the
written care instructions, and that the client has read and understands
the instructions.
(b) The written care instructions for tattooing shall contain at least
the following items:
(1) for at least two weeks, the need to minimize exposure to the sun,
and to discourage swimming in fresh, salt, or chlorinated water;
(2) the need to properly cleanse the tattooed area;
(3) the need to apply antibiotic ointment or cream;
(4) the need to use sterile bandage(s) or other sterile dressing(s) when
necessary;
(5) the name of the artist, and the name, address, and telephone number
of the studio or temporary location; and
(6) the instructions for the client to consult a health care
practitioner at the first sign of infection or an allergic reaction, and
to report any diagnosed infection, allergic reaction, or adverse
reaction resulting from the application of the tattoo to the artist and
to the Texas Department of Health, Drugs and Medical Devices Division,
at 1-888-839-6676.
(c) The written care instructions for body piercing shall contain at
least the following items:
(1) the need to properly cleanse the pierced area by using antibacterial
or antimicrobial soap for the external skin and or an antiseptic or
carbamide peroxide mouthwash for the oral cavity;
(2) for at least the first two to six weeks, the need to minimize
exposure to the sun, and to discourage swimming in fresh, salt, or
chlorinated water;
(3) the need to use sterile bandage(s) or other sterile dressing(s) when
necessary;
(4) the name of the artist, and the name, address, and telephone number
of the studio or temporary location; and
(5) the instructions for the client to consult a health care
practitioner at the first sign of infection or an allergic reaction, and
to report any diagnosed infection, allergic reaction, or adverse
reaction resulting from the body piercing to the artist and to the Texas
Department of Health, Drugs and Medical Devices Division, at
1-888-839-6676.
Source Note: The provisions of this §229.408 adopted to be
effective April 23, 2000, 25 TexReg 3272
Tattooing and Body Piercing
Instruments and Jewelry
(a) Instruments and jewelry used during tattooing and piercing
procedures which may contact blood or other bodily fluids, or which come
in direct contact with skin which is not intact shall be sterilized
after each use or disposed of. These devices include, but are not
limited to, needles, bars, tubes, forceps, receiving tubes, and tapers.
This does not include ear piercing guns or tattoo machines/devices.
(b) Instruments and jewelry used during tattooing and body piercing
which do not come in contact with broken skin but may come in contact
with mucous membranes and oral tissue should be sterilized after each
use. If, however, sterilization is not feasible because the instrument
or jewelry will be damaged, the instrument or jewelry shall be treated
with a germicidal solution prior to use. These devices include, but are
not limited to, calipers and gauge wheels.
(c) Instruments that come into contact only with intact skin shall be
treated with a germicidal solution prior to use. These devices include,
but are not limited to, hand mirrors.
(d) Reusable instruments shall be constructed in a manner that permits
easy cleaning and sterilization.
(e) Needles used to perform body piercing shall be single-use and
disposed of in a sharps container.
(f) Single-use disposable instruments shall be maintained in clean
condition and dispensed in a manner to prevent contamination to the
unused instruments. These devices include, but are not limited to, cups,
cotton swabs, corks, rubber bands, and toothpicks.
(g) Use of styptic pens or alum solids to control blood flow is
prohibited.
(h) All dyes or pigments used in tattooing and piercing shall be
non-toxic, free from adulteration, and made from materials generally
regarded as safe. Marking instruments shall be single-use or sanitized
by design, such as alcohol based ink pens, and shall be used only on
intact skin that has been treated with a germicidal soap. Any marking
instrument that comes in contact with mucous membranes or broken skin
shall be single-use.
(i) Only single-use pigment or dye containers shall be used for each
client. Pigments and dyes shall be dispensed from containers in a manner
to prevent contamination to the unused portion. Individual containers of
dye or pigment shall be discarded after use.
(j) In order to minimize transmission of body fluids and disease,
single-use plastic covers shall be used to cover spray bottles or other
reusable accessories for multiple client use that are handled by the
artist during tattooing and body piercing.
(k) All stencils shall be single-use. Petroleum jellies, soaps, and
other products used in the application of stencils shall be dispensed
and applied using aseptic technique and in a manner to prevent
contamination of the original container and its contents. The applicator
shall be single-use.
(l) Contaminated reusable instruments shall be placed in a labeled
covered container which may contain a disinfectant solution such as 2.0%
alkaline glutaraldehyde (not to be construed as all inclusive) until it
can be cleaned and sterilized.
(m) All containers holding contaminated instruments and container lids
shall be emptied of contaminated solution and cleaned and sanitized
daily or more often if needed.
(n) Reusable instruments shall be cleaned by gloved personnel prior to
sterilization by one of the following methods:
(1) mechanically pre-clean the items by using a clean cotton ball or
swab moistened with a solution of low-residue detergent and cool water,
with care taken to ensure the removal of any pigment or body substances
not visible to the eye, thoroughly rinse with warm water and then drain,
and clean by soaking in a protein dissolving detergent-enzyme cleaner
used according to manufacturer's instructions; or
(2) clean the items in an ultrasonic cleaning unit used according to
manufacturer's instruction. A copy of the manufacturers recommended
procedures for operation of the ultrasonic cleaning unit must be
available for inspection by an authorized agent; and
(3) rinse and dry the items prior to packaging for sterilization.
Source Note: The provisions of this §229.409 adopted to be
effective April 23, 2000, 25 TexReg 3272
RULE §229.410
Report of Infection or Allergic
Reactions
(a) The studio shall provide a written report of any infection or
allergic reaction resulting from a body piercing or the application of a
tattoo to the Texas Department of Health (department) within five
working days of its occurrence or knowledge thereof. The report shall
include:
(1) the name of the affected client;
(2) the name and address of the studio or temporary location where the
tattoo or body piercing was performed;
(3) the name of the artist;
(4) the date the tattoo or piercing was performed;
(5) the specific color or colors of the tattoo or type of jewelry used
for the piercing and, when available, the manufacturer's catalogue or
identification number of each color or type of jewelry used;
(6) the location of the infection and the location on the body where the
tattoo or piercing was applied;
(7) the name and address of the health care practitioner, if any; and
(8) any other information considered relevant to the situation.
(b) The department shall use these reports in their efforts to identify
the source of the adverse reaction(s) and to take action to prevent its
recurrence.
Source Note: The provisions of this §229.410 adopted to be
effective April 23, 2000, 25 TexReg 3272
RULE §229.411
Disposal of Infectious Waste
(a) Sharps shall be subjected to the methods of treatment and disposal
as described in Chapter 1, Subchapter K, §1.136 of this title (relating
to Approved Methods of Treatment and Disposition) and Title 30, Texas
Administrative Code, Chapter 330, Subchapter Y.
(b) Other studio waste generated during the tattooing and body piercing
process, i.e., cotton balls, cotton tip applicators, corks, toothpicks,
tissues, paper towels, gloves, and pigment containers (not to be
construed as all-inclusive) shall be disposed of in accordance with
Chapter 1, Subchapter K, §1.136(a)(2) of this title or Title 30, Texas
Administrative Code, Chapter 330. Copies of these provisions are indexed
and filed in the office of the Drugs and Medical Devices Division, Texas
Department of Health, 1100 West 49th Street, Austin, Texas 78756,
1-888-839-6676, and are available weekdays for inspection between the
hours of 8:00 a.m. and 5:00 p.m.
Source Note: The provisions of this §229.411 adopted to be
effective April 23, 2000, 25 TexReg 3272
RULE §229.412
Refusal, Revocation, or
Suspension of License and Enforcement Provisions
(a) Basis. The Texas Department of Health (department) may, after
providing notice and opportunity for hearing, refuse to license a studio
or temporary location, or may revoke or suspend the license for
violations of the requirements in these sections or for any reasons
described in the Tattoo and Certain Body Piercing Studio Act, or in the
Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431.
(b) Hearing. All hearings for the refusal, revocation or suspension of a
license are governed by the department's formal hearing procedures in
Chapter 1 of this title (relating to the Board of Health), the
Administrative Procedure Act, Government Code, Chapter 2001, and the
hearing rules adopted by the State Office of Administrative Hearings.
(c) Enforcement and penalties.
(1) Administrative penalty. The department may, after providing notice
and opportunity for hearing, assess an administrative penalty as
provided in §146.019 of the Tattoo and Certain Body Piercing Studio
Act, the Health and Safety Code, Chapter 431, and §229.261 of this
title (relating to Assessment of Administrative or Civil Penalties), for
violations of these sections. All hearings for the assessment of an
administrative penalty are governed by the department's formal hearing
procedures in Chapter 1 of this title (relating to the Board of Health)
and the hearing rules adopted by the State Office of Administrative
Hearings.
(2) Civil penalty; Injunction. If it appears that a person has violated
or is violating Health and Safety Code, Chapter 146, or an order issued
or a rule adopted under Health and Safety Code, Chapter 146, the
commissioner may request the attorney general or the district attorney,
county attorney, or municipal attorney in the jurisdiction where the
violation is alleged to have occurred, is occurring, or may occur to
institute a civil suit for:
(A) an order enjoining the violation;
(B) a permanent or temporary injunction, a temporary restraining order,
or other appropriate remedy, if the department shows that the person has
engaged in or is engaging in a violation;
(C) the assessment and recovery of a civil penalty; or
(D) both injunctive relief and a civil penalty.
(3) Criminal penalty. A person commits an offense if the person violates
the Act or rules adopted under the Act. An offense under the Act is a
Class A misdemeanor.
(d) Re-issuance of a license. If a license issued under these sections
has been revoked or denied for violation of these rules, the license
holder named in the revocation or denial is not eligible for licensing
under these sections for a period of two years.
Source Note: The provisions of this §229.412 adopted to be
effective April 23, 2000, 25 TexReg 3272
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER X |
LICENSING OF DEVICE DISTRIBUTORS AND
MANUFACTURERS |
| RULE §229.431 |
Purpose |
These sections provide for the minimum licensure standards necessary
to ensure the safety and efficacy of devices distributed by device
distributors and manufacturers.
Source Note: The provisions of this §229.431 adopted to be
effective October 18, 1994, 19 TexReg 7910; amended to be effective
March 19, 1996, 21 TexReg 1887.
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER X |
LICENSING OF DEVICE DISTRIBUTORS AND
MANUFACTURERS |
| RULE §229.432 |
Applicable Laws and Regulations |
(a) The Texas Department of Health (department) adopts by reference the
following laws and regulations:
(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code, et
seq., as amended;
(2) 21 Code of Federal Regulations (CFR), Part 801, Labeling, as
amended;
(3) 21 CFR, Part 803, Medical Device Reporting, as amended;
(4) 21 CFR, Part 804, Medical Device Distributor Reporting, as amended;
(5) 21 CFR, Part 807, Establishment Registration and Device Listing for
Manufacturers and Distributors of Devices, as amended;
(6) 21 CFR, Part 814, Premarket Approval of Medical Devices, as amended;
(7) 21 CFR, Part 820, Quality System Regulation, as amended;
(8) 21 CFR, Part 897, Cigarettes and Smokeless Tobacco, as amended; and
(9) 21 CFR, Subchapter J--Radiological Health, as amended.
(b) Copies of these laws and regulations are indexed and filed in the
office of the Drugs and Medical Devices Division, Texas Department of
Health, 1100 West 49th Street, Austin, Texas 78756, and are available
for inspection during normal working hours.
(c) Nothing in these sections shall relieve any person of the
responsibility for compliance with other applicable Texas and federal
laws and regulations.
Source Note: The provisions of this §229.432 adopted to be
effective October 18, 1994, 19 TexReg 7910; amended to be effective
March 19, 1996, 21 TexReg 1887; amended to be effective December 13,
1998, 23 TexReg 12353.
| TITLE 25 |
HEALTH SERVICES |
| PART 1 |
TEXAS DEPARTMENT OF HEALTH |
| CHAPTER 229 |
FOOD AND DRUG |
| SUBCHAPTER X |
LICENSING OF DEVICE DISTRIBUTORS AND
MANUFACTURERS |
| RULE §229.433 |
Definitions |
The following words and terms, when used in these sections, shall
have the following meanings, unless the context clearly indicates
otherwise.
(1) Act--The Texas Food, Drug, and Cosmetic Act, Health and Safety Code,
Chapter 431.
(2) Adulterated Device--Has the meaning specified in the Texas Food,
Drug, and Cosmetic Act, Health and Safety Code, Chapter 431, §431.111.
(3) Advertising--All representations disseminated in any manner or by
any means, other than by labeling, for the purpose of inducing, or that
are likely to induce, directly or indirectly, the purchase of food,
drugs, devices, or cosmetics.
(4) Authorized agent--An employee of the department who is designated by
the commissioner to enforce the provisions of this chapter.
(5) Board--The Texas Board of Health.
(6) Commissioner--The Commissioner of Health.
(7) Department--The Texas Department of Health.
(8) Device--An instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory, that is:
(A) recognized in the official United States Pharmacopoeia National
Formulary or any supplement to it;
(B) intended for use in the diagnosis of disease or other conditions, or
in the cure, mitigation, treatment, or prevention of disease in man or
other animals; or
(C) intended to affect the structure or any function of the body of man
or other animals and that does not achieve any of its principal intended
purposes through chemical action within or on the body of man or other
animals and is not dependent on metabolization for the achievement of
any of its principal intended purposes.
(9) Distributor--A person who furthers the marketing of a finished
domestic or imported device from the original place of manufacture to
the person who makes final delivery or sale to the ultimate user. The
term includes an importer or an own-label distributor. The term does not
include a person who repackages a finished device or who otherwise
changes the container, wrapper, or labeling of the finished device or
the finished device package.
(10) Electronic product radiation--Any ionizing or nonionizing
electromagnetic or particulate radiation, or any sonic, infrasonic, or
ultrasonic wave, which is emitted from an electronic product as the
result of the operation of an electronic circuit in such product.
(11) Finished device--A device, or any accessory to a device, which is
suitable for use, whether or not packaged or labeled for commercial
distribution.
(12) Health authority--A physician designated to administer state and
local laws relating to public health.
(13) Importer--Any person who initially distributes a device imported
into the United States.
(14) Ionizing radiation--Any electromagnetic or particulate radiation
capable of producing ions, directly or indirectly, in its passage
through matter. Ionizing radiation includes gamma rays and x-rays, alpha
and beta particles, high speed electrons, neutrons, and other nuclear
particles.
(15) Labeling--All labels and other written, printed, or graphic matter:
(A) upon any article or any of its containers or wrappers; or
(B) accompanying such article.
(16) Manufacture--The making by chemical, physical, biological, or other
procedures of any article that meets the definition of device. The term
includes the following activities:
(A) repackaging or otherwise changing the container, wrapper, or
labeling of any device package in furtherance of the distribution of the
device from the
