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Tattoo artists medical waste disposal regulations - 381.00771-00719
The statute is NOW in effect January 1st, 2012
Read the rules, regulation, & statutes below.
The statute instructs the FDOH to consult with representatives of the tattooing industry (permanent makeup) in Florida during the development of regulations. The statute was sponsored by state rep. Mary Brandenburg, D-West Palm Beach. The Florida Medical Association, the Florida Society of Dermatology and Dermatologic Surgery, the Florida Professional Tattoo Artists Guild, Florida Blood Services, The Florida Association of Beauty Professionals, and The Florida Professional Tattoo Artists Guild supported the legislation.
The new regulations require tattoo artists and tattoo studios (Permanent makeup is considered to be tattooing) to be licensed by the Florida Department of Health, which ill provice classes concerning blood-borne pathogens that must be completed to obtain or renew a license. All tattooing must be done in a facility licensed for tattoo artistry by the Florida Department of Health (FDOH). The new law requires also that no individual under the age of 16 be tyattooed, except for medical reasons by a doctor or dentist. The proposal also calls for any individual under the age of 18 receiving a tattoo to be accompanied by their permanent adult guardian. Tattooing a minor older than 16 years of age, but younger than 18 years of age may not be performed unless:
- The minor is accompanied by his or her parent or legal guardian.
- The minor and parent or legal guardian each submit proof of identification;
- The parent or legal guardian submits written notarized consent;
- The parent or legal guardian submits proof of being the parent or legal guardian to the minor.
The statute provides grounds for discipline, administrative and criminal penalties, licensure fees, and rulemaking authority to the FDOH to implement the tattoo artist and tattoo establishment regulation and repeals the requirement for "general supervision' of tattoo establishments and tattoo artists by a physician or dentist. A person seeking licensure as a tattoo artist must apply to the FDOH in the format prescribed by the FDOH. A tattoo artist application must include the name and residence address of the applicant and the name and street address of each tattoo establishment and temporary establishment at which the applicant intends to practice tattooing in Florida. The DOH shall issue a license to an applicant who:
- Is 18 years of age or older;
- Submits a completed application;
- Pays the applicable license tee;
- Submits proof of successful completion of an education course. approved by the DOH. on blood-borne pathogens and communicable diseases; and
- Submits proof of passage of an examination approved by the DOH on the material presented in the education course.
1. instructs the FDOH to approve one or more education courses and examinations so that applicants can meet the license application requirements. The courses and examinations may be available in person or through an Internet website.
2. requires tattoo artists to notify the DOH within 30 days after any change in the name and residence address of the tattoo artist or the name and street address of each tattoo establishment at which the tattoo artist practiced tattooing for more than 14 days from the most recent application for licensure issuance or renewal.
3. empowers the FDOH to issue a tattoo establishment license to an applicant if the applicant submits a completed application, pays the applicable license fee, and the establishment complies with all applicable local building. Occupational, zoning, and health codes. The statute requires temporary establishments to meet the same requirements for licensure as a permanent tattoo establishment.
4. empowers the FDOH to inspect and investigate each tattoo establishment and temporary establishment as necessary to ensure compliance with ss.
381.00771-381.00791, F.S. 5. requires the FDOH to inspect each tattoo establishment at least annually and must inspect each temporary establishment before, and as necessary during a convention or similar event with which the establishment is connected.
A license is valid only for the location listed in the license. A tattoo establishment must notify the FDOH before any change of the licensed location. A tattoo establishment with more than one location is required to obtain a separate license for each location. A tattoo establishment license is valid for I year and must be renewed annually. A temporary establishment license is valid for the duration of the event for which the license is issued, not to exceed 14 consecutive days. Neither is transferable. A person seeking registration as a guest tattoo (permanent makeup) artist must apply to the FDOH in the format prescribed by the FDOH, hold an active license, registration, or certification issued by a jurisdiction outside of Florida if the education and examination requirements of the license, registration, or certificate substantially meet or exceed the requirements of this statute; or the applicant submits proof of successful completion of an education course approved by the FDOH and proof of passage of an examination approved by the FDOH. A tattoo artist license is valid for I year and must be renewed annually. A guest tattoo artist registration is valid for 14 days, and a guest tattoo artist may reregister before or after expiration of his or her current registration. A tattoo artist license or guest tattoo registration issued by the DOH is not transferable.
- Fee for the initial licensure of a tattoo establishment and the renewal of such license may not exceed $250 per year, except as provided in s. 381.00781 (2), F.S.
- Fee for licensure of a temporary establishment may not exceed $250 per year, except as provided in s. 381.00781 (2), F.S.
- Fee for the initial licensure of a tattoo artist and the renewal of such license may not exceed $150 per year, except as provided in s. 381.00781 (2), F.S.
- Fee for registration or re-registration of a guest tattoo artist may not exceed $45, except as provided in s. 381.00781 (2), F.S.
- Fee for reactivation of an inactive tattoo establishment license or tattoo artist license.
In addition to the expenses incurred to pay licensure fees, persons who perform tattooing or who own establishments where tattooing is performed may incur costs associated with compliance with the regulations specified in the statute. The FDOH will incur costs due to training and examination approval, rule promulgation, development, and presentation of training for county health departments who will inspect the establishments. County health departments will incur costs associated with processing applications, issuing licenses, and conducting inspections, re-inspections, and enforcement. 10D-104.006.
(1) Biomedical waste shall be treated by steam, incineration, or an alternative process approved by the department as described in section 64E-16.007(4), F.A.C., prior to disposal. Treatment shall occur within 30 days of collection from the generator.
(2) Steam treatment units shall subject loads of biomedical waste to sufficient temperature, pressure, and time to demonstrate a minimum Log 4 kill of Bacillus stearothermophilus spores placed at the center of the waste load, and shall be operated in accordance with the following:
(a) Before placing a steam treatment unit into service, operating parameters such as temperature, pressure, and treatment time shall be determined according to the following:
1. Test loads of biomedical waste which consist of the maximum weight and density of biomedical waste to be treated shall be prepared. Separate loads of red bags, sharps containers, boxes, and compacted waste shall be prepared if they are to be treated separately.
2. Prior to treatment, Bacilius stearothermophilus spores shall be placed at the bottom and top of each treatment container, at the front of each treatment container at a depth of approximately one-half of the distance between the top and bottom of the load, in the approximate center of each treatment container, and in the rear of each treatment container at a depth of approximately onehalf of the distance between the top and bottom of the load.
3. If the operating parameters used during the treatment of the test loads demonstrate a minimum Log 4 kill of Bacillus stearothermophilusspores at all locations, the steam treatment unit shall operate under those parameters when placed into service. If the operating parameters fail to provide a minimum Log 4 kill of Bacillus stearothermophilusspores at all locations, treatment time, temperature, or pressure shall be increased and the tests must be repeated until a minimum Log 4 kill of Bacillus stearothermophilus spores is demonstrated at all locations. The steam treatment unit shall be operated under those parameters when placed into service. Tests shall be repeated and new parameters established if the type of biomedical waste to be treated is changed.
(b) When operating parameters have been established and documented using the criteria in paragraph 64E-16.007(2)(a), F.A.C., the steam treatment unit may be placed into service.
(c) The steam treatment unit shall be serviced for preventive maintenance in accordance with the manufacturer's specifications. Records of maintenance shall be onsite and available for review.
(d) Unless a steam treatment unit is equipped to continuously monitor and record temperature and pressure during the entire length of each treatment cycle, each package of biomedical waste to be treated will have a temperature tape or equivalent test material such as a chemical indicator placed on a non-heat conducting probe at the center of each treatment container in the load that will indicate if the treatment temperature and pressure have been reached. Waste shall not be considered treated if the tape or equivalent indicator fails to show that a temperature of at least 250 degrees F (121 degrees C) was reached during the process.
(e) Each steam treatment unit shall be evaluated for effectiveness with spores of Bacillus stearothermophilus at least once each 7 days for permitted treatment facilities, or once each 40 hours of operation for generators who treat their own biomedical waste. The spores shall be placed at the center of the waste load. Evaluation results shall be maintained onsite and available for review.
(f) A written log shall be maintained for each steam treatment unit. The following shall be recorded for each usage:
1. The date, time, and operator name;
2. The type and approximate amount of waste treated;
3. The post-treatment confirmation results by either
a. recording the temperature, pressure, and length of time the waste was treated, or
b. the temperature and pressure monitoring indicator;
(g) A current written operating procedure shall specify, at a minimum, the following:
1. Parameters, determined from testing, that provide consistent treatment, such as exposure time, temperature, and pressure.
2. Identification of standard treatment containers and placement of the load in the steam treatment unit.
3. Incineration of biomedical waste shall be achieved in a biological waste incinerator permitted by the Department of Environmental Protection.
4. An alternative treatment process, such as chemical, gas, dry heat, or microwave shredding, shall be considered by the department upon receipt of a written request. The written request shall be directed to the State Health Officer and shall include:
(a) The specific treatment process and type of facility for which acceptance is sought;
(b) The reason for the request;
(c) Microbiological evidence, using the organisms listed in Table 1, that the proposed process provides sterilization or a satisfactory level of disinfection. Using the protocol described in section 64E-16.007(4), F.A.C., alternative treatment systems must show either:
1. For disinfection, a minimum Log 6 kill 5 for the vegetative organisms listed in Table 1 and a minimum Log 4 kill against Bacillus Stearothermophilus spores utilizing steam or a minimum Log 4 kill against Bacillus Subtilis spores utilizing dry heat, chemicals, or microwave shredding, or
2. For sterilization, a minimum Log 6 kill against Bacillus Stearothermophilus spores utilizing steam or a minumum Log 6 kill against Bacillus Subtilis spores utilizing dry heat, chemicals, or microwave shredding.
a. Bacillus spores - mandatory, species determined by treatment process - Any two
b. Enterococcus faecalis
c. Pseudomonas aeruginosa
d. Staphylococcus aureus
e. Nocardia species
2. Mycobacteria species - any one
a. Mycobacterium bovis
b. Mycobacterium fortuitum
3. Fungus - any one
a. Candida albicans
b. Aspergillus fumigatus
4. Protozoa - Giardia intestinalis or similar
5. Virus - Poliovirus or similar
(d) Each step of the efficacy testing must be thoroughly described in the application for approval. A detailed description of the treatment process, preparation of organisms, preparation of test loads, recovery of organisms, and raw data must be provided.
(e) To begin the efficacy testing, two challenge loads must be sterilized. These loads must be composed of materials commonly found in biomedical waste (tissues, sharps, plastics, glass, woven materials, blood and blood products, etc.), and must be of adequate quantity to equal the maximum capacity of the treatment system. The test load must be fully described (weight, moisture content, composition, etc.).
(f) The purity of all organisms and spores must be certified by a clinical or commercial laboratory. Each organism must be processed separately and placed in the test load in the most difficult location to treat. Before each test run, the total number of viable test organisms must be determined and documented. Treatment of the test load must take place within thirty minutes of inoculating the load with the test organism.
(g) The test load containing the test organism must be processed without the agent (e.g. chemical, microwaves, etc.) used to kill the test organisms. If this agent is a liquid, it must be replaced with an equal amount of sterile saline solution or tapwater. After the test load has completed one cycle in the treatment device, a minimum of three grab samples must be taken from the test load and the number of test organisms present determined. If the number of organisms recovered after the test run is less than Log 6, the number of organisms originally introduced into the device must be increased, and the run must be performed again, until at least Log 6 organisms are recovered. If the number of organisms recovered from the test run is Log 6 or greater, there is an adequate number of organisms being introduced into the device, and the inoculum size should be equal to this number.
(h) Using the inoculum size determined in the above procedure, the second sterilized test load must be inoculated separately. During these test runs, the chemical or physical agent used to treat the waste must be used.
(i) After each test run is completed, the log kill for that particular organism or spore must be calculated. The number of organisms that were not recovered from the initial (non-treating) test run must be subtracted from the number of organisms that were introduced into the second (treatment) run. The number of organisms that survive the treatment process must be subtracted from the first calculation. The resulting figure is the log kill provided by the treatment process.
(j) Approved alternative treatment processes, except single-use, shall meet the requirements of subsection 64E-16.007(2)(e).
(5) Biomedical waste may be disposed into a sanitary sewer system, an onsite sewage treatment and disposal system, or other system approved to receive such wastes by the Department of Environmental Protection or the department, if it is in a liquid or semi-solid form and aerosol formation is minimal.
(6) Body tissues that have been histologically fixed are considered treated biomedical waste. Tissues prepared by frozen sectioning only are not considered treated.
(7) Acute care hospitals, licensed under Chapter 395, F.S., which utilize a certified onsite treatment process involving grinding and treatment, may dispose of such treated biomedical waste in the normal municipal solid waste stream upon notifying the local government responsible for solid waste collection and disposal under the following conditions:
(a) For the purposes of this chapter, certified shall mean that the treatment process is a steam treatment, or has been approved as an alternative biomedical waste treatment process under section 64E-16.007(4), F.A.C.
(b) For the purposes of this chapter, grinding shall also mean shredding or hammermilling.
(c) If grinding takes place prior to treatment, procedures that minimize the chance of exposure to waste handlers must be developed and implemented should the grinder fail or become jammed.
(d) Individuals operating the treatment unit must be trained in all aspects of its operation, including contingency procedures.
(e) Acute care hospitals must inform the department in writing of the installation of the unit at least 30 days prior to placing the unit into service.
(f) Inspection of the unit, including treatment and maintenance records, will occur during the annual inspection for the hospital's biomedical waste permit.
Specific Authority 381.006, 381.0098 FS. Law Implemented 381.006, 381.0098, 395.002(13), 395.1011 FS. History-New 6-19-89, Amended 4-2-90, 12-14-92, 1-23-94, 8-20-95, 6-3-97, Formerly 10D-104.007.
64E-16.008 Biomedical Waste Transport
(1) No registered transporter may knowingly accept biomedical waste for transport unless it has been properly segregated, packaged, and labeled.
(2) Each registered transporter shall provide the generator with a receipt of pick-up.
(3) During transport, no registered transporter shall compact biomedical waste or allow it to leak into the environment.
(4) Transfer of biomedical waste from one transport vehicle to another is not allowed unless the transfer occurs at a permitted storage or treatment facility, except as provided in paragraph 64E-16.008(10)(a), F.A.C. Intermodal transfers of biomedical waste are allowed provided transport shipping seals remain intact.
(5) Any registered transporter who unknowingly fails to comply with subsections (3) or (4) of this section because such biomedical waste has not been properly segregated or separated from other solid wastes by the generating facility is not guilty of a violation under this rule.
(6) No registered transporter shall knowingly deliver biomedical waste for storage or treatment to a facility which does not have a valid permit issued by the department.
(7) All transport vehicles containing biomedical waste shall be visibly identified with the business name, registration number, a 24 hour telephone number, and placards showing the phrase and the international biological hazard symbol as described in paragraph 64E-16.004(2)(a). The symbol shall be at least six inches in diameter.
(8) All transport vehicles containing biomedical waste shall be fully enclosed and secured when unattended.
(9) Registered transporters shall notify the department within one working day by telephone and shall submit a follow-up report to the department within 10 days, in writing, if there is an accident that results in a spill of biomedical waste.
(10) In case of an emergency situation, including mechanical failure, the following is allowed:
(a) If the emergency occurs during transport, biomedical waste may be transferred to another transport vehicle, including a rental vehicle, without being at a storage or treatment facility.
(b) If a rental vehicle is used, the department shall be notified of its use on the first working day after the emergency. A copy of the written authorization from the rental agency stating awareness of the intended use of the vehicle shall be submitted to the department within seven days.
(c) Biomedical waste shall be removed and transported to a permitted storage or treatment facility within 24 hours of the emergency.
(d) Before return to the rental agency, the vehicle shall be decontaminated. Specific Authority: 381.0098 F.S. Law Implemented 381.0098 FS. History-New, 6-3-97, Formerly 10D-104.0073.
64E-16.009 Registration of Biomedical Waste Transporters
(1) Biomedical waste transporters shall be registered with the department. Biomedical waste generators transporting less than 25 pounds of their own biomedical waste, in their own transport vehicle, on any single occasion, are exempt from transporter registration, fee, and placarding requirements of this chapter.
(2) Each owner or operator of a transport vehicle shall submit to the department a completed application for registration on form DH 4106, herein incorporated by reference.
(3) Biomedical waste transporter registrations shall expire on September 30 each year. Renewal applications will not be considered complete without the submission of an annual report on form DH 4109, herein incorporated by reference. Biomedical waste transporters with valid registrations, on the effective date of this chapter, shall renew their registration by September 30 following the expiration date of their existing registration.
(4) Registered transporters shall notify the department in writing within 30 days of any changes made to their registration form currently on file with the department.
(5) Any registered biomedical waste transporter is subject to having their biomedical waste transporter registration denied, suspended, or revoked, pursuant to Section 381.0098, F.S., and in accordance with the procedural requirements of Section 120.60, F.S., upon a finding by the department that the transporter:
(a) Has submitted false or inaccurate information in the application or annual report;
(b) Has violated the provisions of any statute or rule which the department is authorized to enforce;
(c) Has refused to allow inspection of records or equipment by department personnel.
Specific Authority 381.0098 FS. Law Implemented 381.0098 FS. History-New, 6-3-97, Formerly 10D-104.013.
(1) Department personnel shall inspect registered transport vehicles, permitted generators, storage, and treatment facilities at least once a year. Those facilities exempted from the registration and fee requirements under subsection 381.0098(4), shall be inspected at least once every three years. Reinspections may be conducted when a facility is found to be in non-compliance with this chapter. Results of each inspection shall be recorded on a form provided by the department.
(2) To provide consistency of inspections throughout the state, all department personnel who inspect biomedical waste facilities shall attend training annually, which shall be approved by the Bureau of Environmental Health Programs.
Specific Authority 381.006, 381.0098 FS. Law Implemented 381.006, 381.0098 FS. History-New 12-14-92, Amended 1-23-94, 8-20-95, 6-3-97, Formerly 10D-104.0075.
(1) All biomedical waste facilities, except those facilities operating under a Department of Environmental Protection permit, shall obtain a permit from the department annually. Application forms and annual report forms used by the public may be obtained from the environmental health section of the county health department in the county of their location or from the Department of Health, Bureau of Facility Programs, 4052 Bald Cypress Way, Bin A08, Tallahassee, Florida 32399-1710. All forms listed in this section are incorporated by reference.
(a) A biomedical waste generator, who produces or treats less than 25 pounds of biomedical waste in each 30 day period, shall be exempt from all permit and fee requirements of this chapter.
(b) Application for an initial biomedical waste generator permit or exemption from permitting shall be submitted to the department on form DH 4089, Application for Biomedical Waste Generator Permit/Exemption, 8/98. Biomedical waste treatment facilities which were constructed prior to December 31, 1995, or for which an operation permit was submitted to the Department of Environmental Protection prior to December 31, 1995, shall meet the requirements of this chapter at the time of renewal of their existing permit.
(c) Application for an initial biomedical waste storage facility permit shall be submitted to the department on form DH 4107, Application for Biomedical Waste Storage Permit, 8/98.
(d) Application for an initial biomedical waste treatment facility permit shall be submitted to the department on form DH 4111, Application for a Biomedical Waste Treatment Permit, 8/01. Renewals will not be considered complete without the submission of an annual report submitted on form DH 4110, Biomedical Waste Treatment Facility Annual Report, 8/01.
(e) Application for an initial biomedical waste sharps collection program permit shall be submitted to the department on form DH 4108, Application for Biomedical Waste Sharps Collection Program Permit, 8/98.
(f) Permits shall not be transferable from one person to another. In the event of an address or name change, an amended application for permit shall be submitted to the department. A permitted generator may work at a branch office for no more than six hours in any seven day period without applying for an additional permit. These generators must notify the local county health department biomedical waste coordinator of the existence and operating hours of the branch office.
1. In the event of a change of ownership of the facility or a newly constructed facility, an application for an initial permit shall be submitted to the department within 30 days of the commencement of business.
2. When a facility is leased by the owner to a second party for operation, the second party shall apply to the department for an initial permit within 30 days of the commencement of business. The second party shall be held responsible for the operation and maintenance of the facility.
(g) Permits shall expire on September 30 each year. The permit, or a copy thereof, shall be maintained within the facility and shall be made available for review by department personnel.
(2) Persons engaged in a sharps collection program with single or multiple facility locations may operate under a single permit provided:
(a) The sharps collection program is open to the general public;
(b) A list identifying the location of each facility is attached to the application; and
(c) Each facility meets the applicable permit requirements.
Specific Authority 381.006, 381.0098 FS. Law Implemented 381.006, 381.0098, FS. History-New 12-14-92, Amended 1-23-94, 6-3-97, Formerly 10D-104.0076, Amended 11-5-02.
(1) State-owned and operated biomedical waste facilities are exempt from the permit fee.
(2) Fee schedule.
(application received by October 1) $85.00
(application received after October 1) $105.00
(application received by October 1) $85.00
(application received after October 1) $105.00
(application received by October 1) $85.00
(application received after October 1) $105.00
Transporter Registration (one vehicle):
(application received by October 1) $85.00
(application received after October 1) $105.00
Additional Vehicle $10.00
No fee or combination of fees shall exceed the maximum amount established by the statute.
(3) All fees collected pursuant to this section shall be placed in a specially designated account within the individual county health department trust fund to be used to meet the cost of administering the biomedical waste program described in this chapter.
Specific Authority: 381.006, 381.0098(4) FS. Law Implemented 381.006, 381.0098 FS. History-New 12-14-92, Amended 1-23-94, 6-3-97, Formerly 10D-104.0078, Amended 1-12-09.
64E-16.013 Enforcement and Penalties.
(1) According to section 381.0025, F.S., any person who generates, transfers, treats, stores, transports or disposes of biomedical waste in violation of this chapter; or who interferes with, hinders, or opposes any employee of the department in the discharge of his duties, or who impersonates an employee of the department, is chargeable with a misdemeanor of the second degree, punishable as provided in sections 775.082 and 775.083, F.S.
(2) For violation of any provision of Chapter 64E-16, F.A.C., the department shall deny, suspend or revoke any biomedical waste permit or impose an administrative fine of up to $2500 per day for each violation of this chapter or pursue other enforcement action authorized by law. In determining the type and degree of enforcement action necessary, the department shall take into consideration the following:
(a) The gravity of the violation, including the probability that death or serious physical harm to any person may result or has resulted, the severity of the actual or potential harm, and the extent to which the provisions of the applicable statutes or rules were violated.
(b) Actions taken by the owner or operator to correct violations.
(c) Any previous violations.
Specific Authority 381.0061, 381.0098(5) FS. Law Implemented 381.0012, 381.0025, 381.006, 381.0061, 381.0098, 395.002(13), 395.1011, 775.082, 775.083 FS. History-New 6-19-89, Amended 12-14-92, 1-23-94, 6-3-97, Formerly 10
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