| (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: (A) any service and maintenance of lasers that may affect the output power or operating characteristics; or (B) whenever deliberate modifications are made that could change the laser class and affect the output power or operating characteristics. (4) ensuring maintenance and other practices required for safe operation of the laser(s) are performed; (5) ensuring the proper use of protective eyewear and other safety measures; and (6) ensuring compliance with the requirements in this section and with any engineering or operational controls specified by the registrant. (r) Requirements for protection against Class 3b or 4 lasers and IPL device radiation. These requirements are for Class 3b or 4 lasers and IPL devices in their intended mode of operation and include special requirements for service, testing, maintenance, and modification. During some operations, certain engineering controls may be inappropriate. In situations where an engineering control may be inappropriate, for example, during medical procedures or surgery, the LSO shall specify alternate controls to obtain equivalent safety protection. (1) MPE. Each registrant or user of any laser shall not permit any individual to be exposed to levels of laser or collateral radiation higher than are specified in ANSI Z136.1-2000, Safe Use of Lasers and Title 21, CFR, §1040.10 respectively. (2) Instructions to personnel. Personnel operating each laser presently being used or listed on the registrant's current inventory, shall be provided with written instructions for safe use, including clear warnings and precautions to avoid possible exposure to laser and collateral radiation in excess of the MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10. The instructions to personnel shall be maintained in accordance with subsection (ee) of this section for inspection by the agency. (3) Engineering controls. (A) Protective housing. (i) Each laser shall have a protective housing that prevents human access during the operation to laser and to collateral radiation that exceeds the limits of Class 1 lasers as delineated in ANSI Z136.1-2000, Safe Use of Lasers and Title 21, CFR, Part 1040.10, respectively, wherever and whenever such human access is not necessary in order for the laser to perform its intended function. (ii) Wherever and whenever human access to laser radiation levels that exceed the limits of Class 1 is necessary, these levels shall not exceed the limits of the lowest laser class necessary to perform the intended function(s). (B) Safety interlocks. (i) A safety interlock, that shall ensure that radiation is not accessible above MPE limits as delineated in ANSI Z136.1-2000, Safe Use of Lasers, shall be provided for any portion of the protective housing that by design can be removed or displaced during normal operation or maintenance, and thereby allows access to radiation above the MPE limits. (ii) Adjustment during operation, service, testing, or maintenance of a laser containing interlocks shall not cause the interlocks to become inoperative or the radiation to exceed MPE limits outside protective housing except where a laser controlled area as specified in subparagraph (E) of this paragraph is established. (iii) For pulsed lasers, interlocks shall be designed so as to prevent firing of the laser; for example, by dumping the stored energy into a dummy load. (iv) For continuous wave lasers, the interlocks shall turn off the power supply or interrupt the beam; for example, by means of shutters. (v) An interlock shall not allow automatic accessibility of radiation emission above MPE limits when the interlock is closed. (vi) Either multiple safety interlocks or a means to preclude removal or displacement of the interlocked portion of the protective housing upon interlock failure shall be provided, if failure of a single interlock would allow the following: (I) human access to levels of laser radiation in excess of the accessible emission limit of Class 3a laser radiation; or Cont'd... |
