| (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 applicant's compliance history reveals that at least three agency actions have been issued against the applicant, within the previous six years, that assess administrative or civil penalties against the applicant, or that revoke or suspend the certificate of laser registration. (j) Responsibilities of registrant. (1) The registrant shall notify the agency in writing within 30 days of a change in any of the following: (A) business name and mailing address; (B) street address where laser(s) will be used; (C) laser safety officer (LSO). (2) No person shall make, sell, lease, transfer, or lend lasers unless such machines and equipment, when properly placed in operation and used, meet the applicable requirements of this section. (3) Each registrant shall inventory all Class 3B and 4 lasers in their possession at an interval not to exceed one year. The inventory record shall be maintained for inspection by the agency in accordance with subsection (ee) of this section and shall include: (A) manufacturer's name; (B) model and serial number of the laser(s); (C) description of the laser(s) (for example, yag, silicon, CO2, neon); (D) location of laser(s) (for example, room number); and (E) if using a provider of lasers as defined in subsection (d)(38) of this section, a statement with the inventory that the registrant is using lasers provided by a provider of lasers. (4) Notification to the agency is required within 30 days of the following: (A) any increase in the number of lasers authorized by the certificate of laser registration; or (B) if the registrant begins or terminates the use of a provider of lasers as defined in subsection (d)(38) of this section. (5) No registrant shall engage any person for services described in subsection (g)(6) of this section until such person provides to the registrant evidence of registration with the agency. (6) The registrant is responsible for complying with this section and the conditions of the certificate of laser registration. (7) Registrants with certificates of laser registration in accordance with subsection (g)(7) of this section shall have the following documents on site at each laser light show: (A) certificate of laser registration; (B) FDA variance with all applicable documents required by the variance; and (C) instructions for the safe use of lasers in accordance with subsection (r)(2) of this section. (8) Each registrant shall maintain records of receipt, transfer, and disposal of Class 3b or 4 lasers for inspection by the agency. The records shall include the following information and shall be kept until disposal is authorized by the agency: (A) manufacturer's name; (B) model and serial number from the laser; (C) date of the receipt, transfer, and disposal; (D) name and address of person laser(s) received from, transferred to, or disposed of; and (E) name of the individual recording the information. (k) Expiration of certificates of laser registration. (1) Except as provided by subsection (m) of this section, each certificate of laser registration expires at the end of the day, in the month and year stated in the certificate of laser registration. (2) If a registrant does not submit an application for renewal of the certificate of laser registration in accordance with subsection (m) of this section, as applicable, the registrant shall on or before the expiration date specified in the certificate of laser registration: (A) terminate use of all lasers and/or terminate laser servicing or laser services authorized under the certificate of laser registration; (B) submit to the agency a record of the disposition of the lasers, if applicable, and if transferred, to whom it was transferred within 30 days following the expiration date; and Cont'd... |
