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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER GREGISTRATION REGULATIONS
RULE §289.301Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices

  (32) Medical event--Any adverse patient health effect that is a result of failure or misuse of laser safety equipment.

  (33) 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 may be a portable laser that may be removed from the vehicle and taken into a facility for use.

  (34) Nominal hazard zone (NHZ)--The space within which 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.

  (35) Optical density (Dλ )--The logarithm to the base ten of the reciprocal of the transmittance. Dλ = -log10 τ λ , where τλ is transmittance.

  (36) Practitioner of the healing arts (practitioner)--For the purposes of this section, a person licensed to practice the healing arts by either the Texas Medical Board as a physician; the Texas State Board of Dental Examiners; the Texas Board of Chiropractic Examiners; or the Texas State Board of Podiatric Medicine. A practitioner's use of a laser is limited to his/her scope of professional practice as determined by the appropriate licensing agency.

  (37) Protective housing--An enclosure surrounding the laser that prevents access to laser radiation above the applicable MPE level. The aperture through which the useful beam is emitted is not part of the protective housing. The protective housing may enclose associated optics and a work station and shall limit access to other associated radiant energy emissions and to electrical hazards associated with components and terminals.

  (38) Provider of lasers--Provision of lasers on a routine basis to a facility for limited time periods.

  (39) Pulse duration--The duration of a laser pulse. This is usually measured as the time interval between the half-power points on the leading and trailing edges of the laser pulse.

  (40) Pulsed laser--A laser that delivers its energy in the form of a single pulse or a train of pulses. In this section, the duration of a pulse is <5seconds.

  (41) Reflection--The deviation of radiation following incidence on a surface.

  (42) Source--A laser or a laser-illuminated reflecting surface.

  (43) Transmission--Passage of radiation through a medium.

  (44) Ultraviolet radiation--Electromagnetic radiation with wavelengths shorter than those of visible radiation; for the purposes of this section 0.18 to 0.4 µm.

  (45) Visible radiation (light)--In this section, the term is used to describe electromagnetic radiation that can be detected by the human eye. This term is commonly used to describe wavelengths that lie in the range of 0.4 to 0.7 µm.

  (46) Watt--The unit of power or radiant flux. 1 watt equals 1 joule per second.

  (47) Wavelength (λ)--The distance between two successive points on a periodic wave that have the same phase.

(e) Exemptions.

  (1) Lasers in transit or in storage incident to transit are exempt from the requirements of this section. This exemption does not apply to the providers of lasers.

  (2) Inoperable lasers are exempt from the requirements of this section.

  (3) Class 1 (I), IEC Class 1 and 1M, Class 2 (II), IEC Class 2 and 2M, and Class 3a (IIIa), IEC Class 3R lasers or products and IPL devices are exempt from the registration requirements of subsections (f) and (g) of this section.

  (4) Facilities, including academic institutions and research or development facilities, registered for the use of lasers are exempt from the registration requirements of subsections (f) of this section, regarding laser services, and the applicable paragraphs of subsection (g) of this section, to the extent that their personnel perform laser services only for the registrant by whom they are employed.

(f) Registration of use of Class 3b and 4 lasers and laser services.

  (1) For purposes of this section, use of Class 3b or 4 lasers and laser services shall include, but may not be limited to:

    (A) possession and use of lasers in the healing arts, veterinary medicine, industry, academic, and research and development institutions;

    (B) demonstration and sales of lasers that require the individual to operate or cause a laser to be operated in order to demonstrate or sell;

    (C) provision of lasers on a routine basis to a facility for limited time periods by a provider of lasers. For healing arts facilities, the use of lasers shall be directed by a practitioner employed by the contracting facility;

    (D) alignment, calibration, and/or repair; or

    (E) laser light shows.

  (2) A person who has made application for registration in accordance with this section and is using a Class 3b or 4 laser prior to receiving a certificate of laser registration is subject to the requirements of this chapter.

(g) Application requirements.

  (1) General application requirements.

    (A) Application for certificate of laser registration shall be completed on forms prescribed by the agency and shall contain all the information required by the form and accompanying instructions.

    (B) An LSO shall be designated on each application form. The qualifications of that individual shall be submitted to the agency with the application. The LSO shall meet the applicable requirements of subsection (p) of this section and carry out the responsibilities of subsection (q) of this section.

    (C) Each application shall be accompanied by a completed BRC Form 226-1 (Business Information Form).

    (D) Each application for a certificate of laser registration shall be accompanied by the appropriate fee prescribed in §289.204 of this title.

    (E) An application for a certificate of laser registration may include a request for authorization of one or more activities.

    (F) The agency may, at any time after filing of the original application, require further statements in order to enable the agency to determine whether the certificate of laser registration should be granted or denied.

    (G) Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof from public inspection in accordance with §289.231(aa) of this title.

  (2) Application for use of Class 3b or 4 lasers on humans or animals.

    (A) In addition to the requirements of subsection (g)(1) of this section, each person having a Class 3b or 4 laser for use in the healing arts, or for use on animals, shall submit an application to the agency within 30 days after beginning operation of the laser.

    (B) An application for healing arts shall be signed by a licensed practitioner of the healing arts. An application for veterinary medicine shall be signed by a licensed veterinarian. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner's signature if the facility is a licensed hospital or a medical facility. A signature by the administrator, president, or chief executive officer does not relieve the practitioner user or veterinarian user from complying with the requirements of this section.

    (C) If a person is furnished a Class 3b or 4 laser by a provider of lasers, that person is responsible for ensuring that a licensed practitioner of the healing arts authorizes intentional exposure of laser radiation to humans.

  (3) Application for use of Class 3b or 4 lasers in industrial, academic, and research and development institutions. In addition to the requirements of subsection (g)(1) of this section, each applicant having a laser(s) for use in industrial, academic, and research and development institutions shall submit an application to the agency within 30 days after beginning operation of the laser.

  (4) Application for demonstration for the purpose of sales of Class 3b or 4 lasers. Each applicant shall apply for and receive a certificate of laser registration before the demonstration for purpose of selling laser(s) in accordance with paragraph (1) of this subsection.

  (5) Application for providers of Class 3b or 4 lasers.

    (A) Each applicant shall apply for and receive a certificate of laser registration before providing Class 3b or 4 lasers.

    (B) In addition to the requirements of subsection (g)(1) of this section, the applicant shall submit the address of the established main location where the laser and records will be maintained for inspection. This shall be a physical street address, not a post office box number.

  (6) Application for alignment, calibration, and/or repair of Class 3b or 4 lasers. In addition to the requirements of subsection (g)(1) of this section, each applicant shall apply for and receive a certificate of laser radiation for alignment, calibration, and/or repair before providing alignment, calibration, and/or repair of Class 3b or 4 lasers or other lasers that allow access, through alignment, calibration, and/or repair, to Class 3b or 4 lasers.

  (7) Application for laser light show.

    (A) Each applicant shall apply for and receive a certificate of laser registration for a laser light show before beginning any show.

    (B) In accordance with subparagraph (A) of this paragraph and in addition to the requirements of subsection (g)(1) of this section, each applicant shall submit the following:

      (i) a valid variance issued from the FDA for the laser intended to be used with all applicable documents required by the variance; and

      (ii) a written notice of the laser light show to be performed in Texas. The information contained in BRC Form 301-3 shall be provided at least seven days prior to each show. If, in a specific case, the seven-day period would impose an undue hardship on the applicant, the applicant may, upon written request to the agency, obtain permission to proceed sooner.

  (8) Application for mobile service operation for Class 3b or 4 lasers used in the healing arts and veterinary arts.

    (A) Each applicant shall apply for and receive a certificate of laser registration for mobile service operation involving Class 3b or 4 lasers before beginning mobile service operation.

    (B) In addition to the requirements of subsection (g)(1) of this section, each applicant shall submit the address of the established main location where the laser, records, etc., will be maintained for inspection. This shall be a physical street address, not a post office box number.

    (C) An application for mobile service operation for the healing arts shall be signed by a licensed practitioner of the healing arts and an application for mobile services for veterinary medicine shall be signed by a licensed veterinarian.

(h) Issuance of certificate of laser registration.

  (1) Upon determination that an application meets the requirements of the Texas Radiation Control Act (Act) and the rules of the agency, the agency may issue a certificate of laser registration authorizing the proposed activity in such form and containing such conditions and limitations as the agency deems appropriate or necessary.

  (2) The agency may incorporate in the certificate of laser registration at the time of issuance, or thereafter by amendment, additional requirements and conditions with respect to the registrant's receipt, possession, use, and transfer of lasers subject to this section as it deems appropriate or necessary in order to:

    (A) minimize danger to occupational and public health and safety;

    (B) require additional reports and the keeping of additional records as may be appropriate or necessary; and

    (C) prevent loss or theft of lasers subject to this section.

  (3) The agency may request, and the registrant shall provide, additional information after the certificate of laser registration has been issued to enable the agency to determine whether the certificate of laser registration should be modified in accordance with subsection (n) of this section.

(i) Specific terms and conditions of certificates of laser registration.

  (1) Each certificate of laser registration issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable rules in this chapter and orders issued by the agency.

  (2) Each person registered by the agency for laser use in accordance with this section shall confine use and possession of the laser registered to the locations and purposes authorized in the certificate.

  (3) No certificate of laser registration issued or granted under this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person unless the agency authorizes the transfer in writing.

  (4) In making a determination whether to grant, deny, amend, renew, revoke, suspend, or restrict a certificate of laser registration, the agency may consider the technical competence and compliance history of an applicant or holder of a certificate of laser registration. After an opportunity for a hearing, the agency shall deny an application for a certificate of laser registration, an amendment to a certificate of laser registration, or renewal of a certificate of laser registration if the Cont'd...

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