All laser products made since August 1976 must meet the FDA laser performance standard. Each manufacturer of laser products must report to FDA about the types of laser products produced.
The standard divides laser products into four classes, bas ed on the potential for injuring people and the intensity of the radiation in the laser beam (the power of the laser beam is measured in watts*).
Class I products produce levels of radiation that have not been found to cause biological damage. Class I visible radiation lasers emit less than 0.39 mi crowatts (or 0.39 millionths of a watt) continuous output.
*The term "watts," when used to describe laser output, is NOT equivalent to wattage, when used to describe an electric light. Refer to page 28 of Appendix I for an explanation of the distinction.
Class II lasers produce radiationthat could cause eye damage after direct, longterm exposure. Class II lasers emit less than 1 milliwatt (or 1 thousandth of a watt) continuous output.
Class III laser products produce radiation powerful enough to injure human tissue with one short exposure to the direct beam or its direct reflections off a shiny surface. Class Ill visible radiation lasers emit less than 500 milliwatts (or onehalf watt) continuous output.
Class III is subdivided into Classes IIIa and IIIb. Class IIIa is limited to five milliwatts in the visible spectrum. More stringent requirements apply to Class IIIb lasers.
Class IV lasers produce radiation so powerful that it can cause injury with a direct or reflected exposure, even when the beam is scattered or diffused by a rough surface or even by some smoke screens. Class IV visible radiation lasers emit more than onehalf watt continuous output.
All laser products above Class I, made after August 1976, must have labels that indicate the class to which they belong. Additional safety design and labeling features are required according to the class of the product.
FDA's standard was developed when the use of lasers in the entertainment world was in its infancy. Lasers for demonstration purposes fell primarily into Class I or II and the standard reflected this. But because of the low visibility of their beams, Class I and II lasers are not effective with very large crowds. The light shows at concerts and discotheques nowadays often use Class IIIb and even Class IV lasers. FDA recognizes that it is possible to use these high powered lasers in such a way that they will be as safe as Class I and II demonstration lasers as longas the manufacturers can assure safety. FDA does this by means of a "variance." A variance is permission from FDA to deviate from one or more of the requirements of a standard when alternate steps are taken to assure safety. Before May 1980, all of the safety requirements described below were imposed for laser shows except the requirement of an approved variance prior to performance. As of September 20, 1985, the following policy is legally binding:
Before Class IIIb or Class IV lasers are sold, used in performances, or otherwise introduced into commerce for demonstration or entertainment purposes, manufacturers must have an approved variance from FDA.
Laser manufacturers include people who make laser produds and people who receive compensation to design, assemble, or modify a laser projector and/or light show.
This means that a musical group or others are considered manufacturers if they assemble a show. . .even if the act of manufacture is simply setting up a show in a particular location or changing a general purpose laser to light show use, without adding any new laser components. This does not mean that "all the world's a laser manufacturer." And it does not mean that a separate variance is needed for each laser show. But it does mean that first, the manufacturers of all Class IIIb or IV laser products used in shows that do not already have a variance, must obtain one for each type of show performed. Second, all "manufactured" must submit to FDA a report on all thetypes of laser products manufactured. A variance must be obtained before a laser can be used in a performance or display.
FDA uses several safety criteria to determine whether a variance will be granted to a laser light show. These criteria include:
The laser must meet all the design and labeling requirements of its class and the following.
Laser radiation cannot exceed Class I limits where the audience is located. (This can be achieved by proper use of mirror balls, scanning devices, or other safeguards.)
If devices, like mirror balls or flat mirrors, are used to reflect the beam, scanning safeguards or other measures are required to make sure that laser radiation above Class I will not accidentally go into the audience.
Performerscannot be exposed to radiation above Class I limits if they must view the laser beam in the course of a performance. When they don't have to view the laser beam, performers cannot be exposed to radiation above Class II limits.
If the laser is not under the continuous control of an operator, laser radiation above Class II limits must be restricted so that it comes no closer than 6 meters (about 20 feet) above, or 2.5 meters (about 8 feet) on the sides or below the floor where the audience would be.
If the laser is under the continuous control of an operator, laser radiation above Class II limits can come no closer than 3 meters (about 10 feet) above or 2.5 meters (about 8 feet) on the sides or below the floor where the audience would be.
Appropriate controls must be taken to make sure that unauthorized persons cannot interfere with the safe operation of the laser. A person must be designated as the laser safety officer who will be responsible for shutting down the laser should any unsafe conditions occur (e.g., should individuals in the audience try to get within the direct laser beam by climbing on a chair or someone's shoulders, or should reflective articles be thrown in the beam). In some situations, as when the audience becomes unruly, strict security measures should be taken to keep the laser operating area free and under the full control of the authorized personnel.
Other criteria may be included depending upon the particular show. They may include such requirements as compliance with State and local requirements, contacting the Federal Aviation Administration for outdoor shows, certification of operators, use of laser cutoff devices or safety shields, time limitations for particular effects and restrictions on the location of the operator or performers.
Once a variance is granted, representativesof FDA must be allowed to inspect the laser equipment and the safety procedures to assure that the conditions of the variance are met.
FDA should be notified in writing of all shows at least 1 month in advance. When this is not possible bcause of last minute scheduling, FDA should be notified by telephone as soon as possible and then a written confirmation should be sent to FDA.
Anyone who operates laser light shows without an approved FDA variance or who otherwise violates the FDA laser safety standard may be subject to a court injunction andlor civil penalties (fines up to $300,000) as provided for in Section 360C of the Radiation Control for Health and Safety Act. When FDA becomes aware of a particular laser show that is operated in violation of the law or otherwise in an irresponsible fashion, FDA will notify the manufacturer or operator and require corrective action. If the problem is serious, FDA will also notify the State and local authorities and facility managers who can take additional, immediate legal steps to halt a hazardous show.
To apply for a variance or for more information about the variance status of a particular laser show manufacturer, reporting requirements, variance applications and safe operationof laser light shows, contact:
Office of Compliance HFZ312
Center for Devices and
Radiological Health
8757 Georgia Avenue
Silver Spring, MD 20910
(301) 4278228
Even though the chances are small that an aircraft passenger or pilot would be injured by a laser beam from an outdoors light show, the possibility of harm does exist. Therefore, the Federal Aviation Administration must be notified before any open air laser light shows operate.
FAA will not object if the output power of the laser beam is less than or equal to one half watt (that is, the laser is Class I, II, or Ill). As long as aircraft fly no closer than the required 1,000 feet over congested areas or over an outdoor assembly of people, there should be little risk from a laser beam of this power. If the show is adjacent to an airport, however, the FAA may object because of the possible risk to aircraft landing and taking off.
FAA will not object to open air shows with Class IV laser beam powers between onehalf and 12 watts if the laser manufacturerloperator informs FAA of the location, time and laser output sufficiently in advance of the show and if FAA can restrict the air traffic in the area.
In most cases, FAA will object if the laser beam power is greater than 12 watts. A laser of this power is rarely needed for an effective light show and could require extensive restrictions on air traffic.
Notification to the FAA of a proposed open air laser light show should be made in writing at least 2 weeks and preferably 4 weeks in advance of the performance. FAA can usually respond with a determination within 7 days. The notification should be directed to the Chief of the Airspace and Procedures Branch at the regional office having jurisdiction over the area where the laser show will take place. The addresses and phone numbers of the appropriate office for each area will be found in Appendix II.
State and municipal governments can have their own requirements, beyond those of FDA and FAA, with which laser light shows must comply when operating in their jurisdictions. Presently, 6 State agencies have specific legislation for lasers and 25 have the authority to develop specific laser regulations. In addition, all States and many local agencies have the authority to take action if a laser show endangers the general health and safety of the public. Several States have closed down laser shows that violated the FDA safety requirements.
The State agencies with the responsibility for radiation control should be notified in advance of laser shows operating within the State boundaries. The following information should be provided in writing by the laser safety officer from either the operating group or the facility where the show is held:
Name, address, and phone number of laser safety officer(s1 or operator(s)
Name, address, and phone number of the auditorium facility and the manager
Type of laser show
Date(s) and time of performance (if it is not an ongoing show)
Length of time laser will be in operation
Expected attendance
Class of laser and name of manufacturer
Sketches to describe the design or layout of the show
If Class IIIb or IV laser product, FDA variance and accession number and date of the variance approval
Since the State requirements vary, it is important that laser show operators or facility managers contact the appropriate office directly to notify the authorities of the operation of a laser show and to ascertain what, if any, additional requirements exist. The State personnel will also be aware of any relevant municipal requirements. Managers of facilities where laser shows are held should be familiar with any local safety requirements. The addresses and phone numbers of the State radiation control offices will be found in Appendix Ill of this booklet.
Source: Excerpted from Laser Light Show Safety: Who's Responsible? PDF June 1980; Revised May 1986