(a) Purpose.(1) This section establishes requirements for protection against all classes of laser radiation and intense-pulsed light (IPL) device hazards. This section includes the responsibilities of the registrant and the laser safety officer (LSO), laser and IPL device hazard control methods, training requirements, and notification of injuries.(2) For the purpose of this section, any reference to a class of laser includes both International Electrotechnical Commission (IEC) and United States Food and Drug Administration (FDA) classifications, as appropriate.(3) This section establishes requirements for the registration of a person who receives, possesses, acquires, uses, or transfers Class IIIb (3B), or Class IV (4) lasers in the healing arts, veterinary medicine, and industrial, academic, research and development institutions, and of a person in the business of providing laser services.(A) A person must not use a Class 3B or Class 4 laser or perform laser services except as authorized in a certificate of registration issued by the Texas Department of State Health Services (department) as specified in this section.(B) A person who receives, possesses, uses, owns, or acquires a Class 3B or Class 4 laser before receiving a certificate of registration is subject to the requirements of this chapter. (4) Class I (1) lasers, Class II (2) lasers, FDA Class IIIa (3a) lasers, IEC Class 3R lasers, and IPL devices are not required to be registered. However, the use of Class 1, Class 2, Class 3a, Class 3R lasers, and IPL devices is subject to applicable requirements in this section.(b) Scope.(1) Except as otherwise provided, this section applies to a person who receives, possesses, acquires, transfers, or uses lasers that emit or may emit laser radiation. Lasers or IPL devices must not be used on humans or animals unless under the supervision of a licensed practitioner of the healing arts (practitioner) or veterinary medicine and unless the use of lasers or IPL devices is within the scope of their professional license. This section does not limit the intentional exposure of patients to laser or IPL device radiation for the purpose of diagnosis, therapy, or treatment by a practitioner of the healing arts or veterinary medicine within the scope of their professional license. This section does not apply to the manufacture of lasers or IPL devices.(2) This section applies to lasers operating at wavelengths between 180 nanometers (nm) and 1 millimeter (mm).(3) This section applies to IPL devices. These devices must be Class 2 or Class 3 surgical devices certified as complying with the designing, labeling, and manufacturing standards of the FDA.(4) This section applies to lasers meeting the requirements of IEC standards 60825-1 and 60601-2-22 as allowed by the FDA Centers for Devices and Radiological Health in the current Laser Notice guidance document.(5) In addition to the requirements of this section, all registrants authorized to use Class 3B and Class 4 lasers are subject to the following requirements:(A) §289.203 of this chapter (relating to Notices, Instructions, and Reports to Workers; Inspections) except for subsection (d), "Notifications and reports to individuals," and information relating to ionizing radiation or exposure history contained in subsection (i), "Notice to employees."(B) §289.204 of this chapter (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);(C) §289.205 (a), (b), and (h) - (n) of this chapter (relating to Hearing and Enforcement Procedures); and(D) §289.231 (d), (f) - (j), (aa), (bb), (ff), (kk), and (ll)(1), (2), and (5) of this chapter (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation) and the applicable definitions in §289.231(c) of this chapter.(c) Prohibitions.(1) The department prohibits the use of lasers and IPL devices posing a significant threat or endangering occupational or public health and safety as specified in §289.205 and §289.231 of this chapter.(2) An individual must not be intentionally exposed to laser or IPL radiation above the maximum permissible exposure (MPE) unless a practitioner has authorized such exposure.(A) Exposure of an individual for training, demonstration, or other non-healing arts purposes is prohibited unless authorized by a practitioner.(B) Exposure of an individual for the purpose of healing arts screening is prohibited, except as specifically authorized by the department.(C) Research and development using radiation machines on humans is prohibited except for the following. (i) Any research using radiation machines on humans must be approved by an Institutional Review Board (IRB) as required by 45 Code of Federal Regulations (CFR) Part 46, and 21 CFR Part 56. The IRB must include at least one physician to direct any laser radiation or IPL device use as specified in subsection (b)(1) of this section.(ii) Facilities with radiation machines, with investigational device exemptions, involved in clinical studies must follow regulations governing the conduct of clinical studies and applying to the manufacturers, sponsors, clinical investigators, IRBs, and the medical device. These regulations include:(I) 21 CFR Part 812, Investigational Device Exemptions;(II) 21 CFR Part 50, Protection of Human Subjects;(III) 21 CFR Part 56, Institutional Review Boards;(IV) 21 CFR Part 54, Financial Disclosure by Clinical Investigators; and(V) 21 CFR Part 820, Subpart C, Design Controls of the Quality System Regulation.(d) Definitions. The following words and terms, when used in this section, have the following meanings, unless the context indicates otherwise.(1) Access to laser radiation--Proximity to radiation not blocked by an intervening barrier or filter.(2) Accessible emission limit (AEL)--The maximum accessible emission level permitted within a particular class.(3) Accessible laser radiation--Proximity to radiation not blocked by an intervening barrier or filter.(4) American National Standards Institute (ANSI) standards--Specific standards for lasers and IPL devices published by the American National Standards Institute.(5) Aperture--An opening through which radiation can pass.(6) Beam--A collection of rays characterized by direction, diameter (or dimensions), and divergence (or convergence).(7) Class 1 laser--Any laser not permitting human exposure during operation to levels of visible laser radiation more than the accessible emission limits contained in ANSI.(8) Class 2 laser--Any laser permitting human exposure during operation to levels of visible laser radiation more than the accessible emission limits of Class 1 lasers contained in ANSI but does not permit human exposure during operation to levels of visible laser radiation more than the accessible emission limits of Class 2 lasers contained in ANSI.(9) Class 3a laser, IEC Class 3R--Any laser permitting human exposure during operation to levels of laser radiation more than the accessible emission limits of Class 2 lasers contained in ANSI but does not permit human exposure during operation to levels of laser radiation more than the accessible emission limits of Class 3a lasers contained in ANSI.(10) Class 3B laser--Any laser permitting human exposure during operation to levels of laser radiation more than the accessible emission limits of FDA Class 3a lasers in ANSI but does not permit human exposure during operation to levels of laser radiation in excess of the emission limits of Class 3B lasers contained in ANSI.(11) Class 4 laser--Any laser permitting human exposure during operation to levels of laser radiation more than the accessible emission limits of Class 3B lasers contained in ANSI.(12) Coherent--A light beam is coherent when the electric vector at any point in it is related to any other point by a definite, continuous function.(13) Collateral radiation--Any electromagnetic radiation, except laser radiation, emitted by a laser that is physically necessary for its operation. The applicable, accessible emission limits for collateral radiation are found in 21 CFR §1040.10.(14) Continuous wave--A laser operating with a continuous output for greater than or equal to 0.25 seconds is regarded as a continuous wave laser.(15) Controlled area--An area where the occupancy and activity of those within are subject to control and supervision by the registrant for the purpose of protection from radiation hazards.(16) Divergence--The increase in the diameter of the laser beam with propagation distance from the exit aperture. This is also referred to as beam spread The value of the divergence is expressed in radians or milliradians.(17) Electromagnetic radiation--Radiation consisting of electromagnetic waves, including x-ray, ultraviolet, visible, infrared, and radio waves occupying various portions of the electromagnetic spectrum and differing only in frequency, wavelength, or photon energy.(18) Electronic product--Any product or article defined as follows:(A) any manufactured or assembled product, when in operation:(i) contains or acts as part of an electronic circuit; and(ii) emits, or in the absence of effective shielding or other controls would emit electronic product radiation; or(B) any manufactured or assembled article intended for use as a component, part, or accessory of a product described in subparagraph (A) of this paragraph and when in operation emits, or in the absence of effective shielding or other controls would emit radiation.(19) Energy--The capacity for doing work. Energy content is commonly used to characterize the output from pulsed lasers and is expressed in joules (J).(20) Engineering controls--Control measures designed or incorporated into the laser or laser system (e.g., interlocks, shutters, watchdog timer) or its application.(21) Healing arts--Any system, treatment, operation, diagnosis, prescription, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.(22) Infrared radiation--The region of the electromagnetic spectrum between the long-wavelength extreme of the visible spectrum (about 0.7 micrometer (µm)) and the shortest microwaves (about 1 mm).(23) Inoperable--Incapable of operation because of damage, disassembly, removal, or inactivation of key components that cannot be restored without significant repair or renovation.(24) Institutional Review Board (IRB)--Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct a periodic review of biomedical research involving human subjects.(25) Intense-pulsed light (IPL) device--A device that emits radiation to energy density levels that could cause bodily harm and used for photothermolysis. This device is a Class 2 or Class 3 surgical device certified as complying with FDA designing, labeling, and manufacturing standards.(26) Invisible radiation--Laser or collateral radiation having wavelengths greater than or equal to 180 nm but less than or equal to 400 nm or greater than 710 nm but less than or equal to 1.0 x 106 nm (1 millimeter).(27) Irradiance--Radiant power incident per unit area upon a surface, expressed in watts-per-square-centimeter (W-cm-2 ).(28) Joule (J)--A unit of energy. One joule is equal to one watt • second.(29) Laser--An electronic device that emits stimulated radiation to energy density levels that could cause bodily harm. A laser may also produce an intense, coherent, directional beam of light by stimulating electronic or molecular transitions to lower energy levels. The term "laser" includes the assembly of electrical, mechanical, and optical components associated with the laser. A laser can be a component of a product or system.(30) Laser light show--Use of lasers for entertainment, advertising display, or artistic composition.(31) Laser product--Any manufactured product or assemblage of components constituting, incorporating, or intending to incorporate a laser and is classified as a Class 1, Class 2, Class 3a, Class 3B, or Class 4 laser product according to the performance standards set by the FDA. A laser intended for use as a component of an electronic product must be considered a laser product. A laser product can contain an enclosed laser with an assigned class number higher than the inherent capability of the laser product in which it is incorporated and where the product's lower classification is appropriate due to the engineering features limiting accessible emission.(32) Laser safety officer (LSO)--An individual with knowledge of and the authority and responsibility to apply appropriate laser radiation protection rules, standards, and practices, and is specifically authorized on a certificate of laser registration.(33) Manufacturer--Any person who designs, manufactures, assembles, fabricates, or processes a finished laser device.(34) Maximum permissible exposure (MPE)--The level of laser radiation a person may be exposed to without hazardous effects or adverse biological changes in the eye or skin. Maximum permissible exposures to laser radiation may be found in ANSI.(35) Medical event--Any adverse patient health effect directly resulting from the use of laser equipment on an individual.(36) Mobile service operation--The provision of lasers and personnel at temporary sites for limited time periods. The lasers may be fixed inside a motorized vehicle or a portable laser that can be removed from the vehicle and taken into a facility for use.(37) Nominal hazard zone (NHZ)--The space where the level of direct, reflected, or scattered radiation during operation exceeds the applicable MPE. Exposure levels beyond the boundary of the NHZ are below the applicable MPE level.(38) Optical density (D&lgr )--The logarithm to the base ten of the reciprocal of the transmittance. D&lgr = -log10 &tgr&lgr , where &tgr&lgr is transmittance.(39) Personal protective equipment (PPE)--Device used to mitigate hazards associated with laser use, including laser eye protection (LEP), protective clothing, and gloves.(40) Practitioner--A person licensed under Texas Occupations Code