| 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 (C) pay any outstanding fees in accordance with §289.204 of this title. (3) Expiration of the certificate of laser registration does not relieve the registrant of the requirements of this chapter. (l) Termination of certificates of laser registration. When a registrant decides to terminate all activities involving laser or laser services authorized under the certificate of laser registration, the registrant shall immediately do the following: (1) request termination of the certificate of laser registration in writing; (2) submit to the agency a record of the disposition of the radiation machines, if applicable; and if transferred, to whom it was transferred; and (3) pay any outstanding fees in accordance with §289.204 of this title. (m) Renewal of certificate of laser registration. (1) An application for renewal of a certificate of laser registration shall be filed in accordance with subsection (g)(1)(A) - (B), and (E) - (G) of this section and applicable paragraphs of subsections (g)(2), (4), and (7) of this section. (2) If a registrant files an application for a renewal in proper form before the existing certificate of laser registration expires, such existing certificate of laser registration shall not expire until the application status has been determined by the agency. (n) Modification, suspension, and revocation of certificates of laser registration. (1) The terms and conditions of all certificates of laser registration shall be subject to revision or modification. (2) Any certificate of laser registration may be revoked, suspended, or modified, in whole or in part, for any of the following: (A) any material false statement in the application or any statement of fact required under the provisions of the Act; (B) conditions revealed by such application or statement of fact, or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a certificate of laser registration on an original application; (C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, or of the certificate of laser registration, or order of the agency; or (D) existing conditions that constitute a substantial threat to the public health or safety or the environment. (3) Each certificate of laser registration revoked by the agency ends at the end of the day on the date of the agency's final determination to revoke the certificate of laser registration, or on the revocation date stated in the determination, or as otherwise provided by the agency order. (4) Except in cases in which the occupational and public health or safety requires otherwise, no certificate of laser registration shall be suspended or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been afforded an opportunity to demonstrate compliance with all lawful requirements. (o) Notifications. The following applies to voluntary or involuntary petitions for bankruptcy. (1) Each registrant shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy by the registrant or its parent company. This notification shall include: (A) the bankruptcy court in which the petition for bankruptcy was filed; and (B) the date of the filing of the petition. (2) A copy of the "petition for bankruptcy" shall be submitted to the agency along with the written notification. (p) LSO qualifications. LSO qualifications shall be submitted to the agency and shall include the following: (1) educational courses related to laser radiation safety or a laser safety officer course; or (2) experience in the use and familiarity of the type of equipment or services registered for; and (3) knowledge of potential laser radiation hazards and laser emergency situations. (q) LSO duties. Specific duties of the LSO shall include, but not be limited to the following: (1) ensuring that users of lasers are trained in laser safety, as applicable for the class and type of lasers the individual uses; (2) assuming control and having the authority to institute corrective actions including shutdown of operations when necessary in emergency situations or unsafe conditions; and (3) specifying whether any changes in control measures are required following: Cont'd... |
