Laser manufacturers (including operators or people who set up or assemble laser systems) should have a good understanding of the FDA laser performance standard, the requirements for the class of laser product with which they are concerned and the safety requirements for laser light show operations.
FDA and State personnel are available to help you make sure that your shows are run safely and in compliance with the law. For more information, contact the appropriate State office listed in Appendix Ill of this booklet, or:
Office of Compliance HFZ-312 Center for Devices and
Radiological Health
8757 Georgia Avenue
Silver Spring, MD 20910
(301) 427-8228
Specifically, the following responsibilities are those of the laser manufacturer or operator of light shows:
You must notify FDA, in writing, at least 1 month in ad-vance of a show. In cases of traveling shows, you may want to send to FDA the schedule for the entire tour. When this is not possible because of last minute scheduling, you should notify FDA by telephone as far in advance as possible and then confirm it in writing.
You must contact the State or local radiation control authorities in writing in ad-vance of conducting a laser show in their jurisdiction. Again, when this is not possi-ble, you should telephone the State agency as far in advance as feasible. The information you should provide to the State is listed on page 21 of this book-let. In some areas, they also have operating requirements beyond FDA's. (See Appendix Ill of this booklet for ii list of the State authorities who must be contacted.)
You should also provide to the facility manager the information that is given to the State authority.
If you are responsible for an outdoor laser light show, you must notify the Federal Aviation Administration. (See Appendix II of this booklet for a list of which FAA office must be con-tacted.)
If there are any radiation ac-cidents or alleged accidents, that is, if someone is hurt or an accidental exposure to a laser beam of Class Ill or IV occurs, you must report the incident to the local authority and FDA regardless of whether any actual injuries occurred.
As of September 20, 1985, if you will be using a Class lllb or IV laser in light shows or displays, you must submit a variance ap-lication and receive an approved variance from FDA before a performance. You may be asked to show the documents to verify your variance to State or local authorities and facility managers. In fact, this is required in some jurisdictions. Because the public is becoming increasingly aware of potential laser hazards, you may want to include a statement in any promotional advertising of your laser show that it will be operated in conformance with FDA laser safety criteria. If you do so, however, you can-not imply that the show is "endorsed" or "approved" by FDA.
Before granting a variance, FDA will require that a report be filed describing your laser pro-ducts and the manner by which they comply with the FDA laser safety standard and the con-ditions of any variances. This "initial report" must be followed up by a "model change report" should you plan to introduce a new or modified laser show or device into commerce. An annual report must also be sub-mitted by September 1 of each year summarizing the testing and the records that must be maintained.
In order to safeguard your audiences,you should be aware of the safety requirements plac-ed on the manufacturers and operators of laser shows by Federal, State and local authorities. To avoid possible liability for laser injuries, see that any shows in your facility have complied with the legal requirements.
NOTE: The laser operator should provide to you the information about the class of laser to be used and its variance status. A laser product should have a label indicating its class. If the laser is Class lllb or IV, the company responsible for the laser should have documentation (an accession and variance number) from FDA granting a variance. You can contact the State authority (see Appendix Ill of this booklet) or FDA to verify the status of a company's variance.
One person, either the laser company's operator, or where there is no operator, an em-ployee from the facility, should be designated as laser safety officer. A laser safety officer should be in attendance whenever a laser is in operation and should be responsible for shutting down the laser should any unsafe conditions occur.
In order to properly set up and align a laser light system that can be operated safely, laser groups will need time in the facility before the show without members of the public present. They will need the electrical power and water sup- ply set up early enough to test and align the equipment. Depending upon the complexity of the system, the preparation for a show may take up to several hours. Should a full inspection by FDA representa- tives be found necessary, it may require an additional hour or two prior to the show. This should be allowed for in the scheduling of performances.
Should any accident occur with the laser, you should report the incident to the State authority and to FDA.
FDA and State personnel are available to help you ensure that laser shows in your facility are run safely and in com- pliance with the law. Contact the FDA or the appropriate State office listed in Appendix Ill for more information.
Laser light shows can be ex- citing but they can also be hazardous if someone is ac-cidentally struck (particularly in the eyes) by direct, reflected or even diffuse high power laser radiation.
You have a right to enjoy a laser show knowing that your safety is provided for by the laser manufacturer, the laser operator and the management of the facility where the show is held. Should you have reason to believe that a show is not being run safely that is, that the precautions spelled out in this booklet are not being taken talk with the laser operator or people in charge of the facility, or call the State authority (listed in Appendix Ill). If you are aware of anyone being injured at a laser show, report it to the State authority or FDA.
Source: Excerpted from Laser Light Show Safety: Who's Responsible? PDF June 1980; Revised May 1986