IF YOUR SHOW LASED SOMEONE

Disclaimer: The following information is given for guidance only. It does not legally bind FDA, German authorities or ILDA to any particular requirement or course of action. Also, for healthcare information about treating suspected or actual eye injuries, see this page.

In the United States - Federal level


At the federal level, U.S. Food and Drug Administration regulations require reporting any potential laser exposure above the Maximum Permissible Exposure (MPE) limit. The information below in blue type was provided to ILDA in April 2016:


Variances and exemptions address what would be non-compliances with the laser performance standard. Exemptions may address relief from certain reporting and recordkeeping requirements. All electronic product manufacturers are responsible for sending an Accidental Radiation Occurrence Report under “Subpart C – Manufacturers’ Report on Accidental Radiation Occurrences, 21 CFR 1002.20.” [Note that under FDA regulations, a laser light show is a “laser product” or an “electronic product.” Thus, the requirements below would apply.]

An accidental radiation occurrence (ARO) is defined (21 CFR 1000.3(a)) as, “a single event or series of events that has/have resulted in
injurious or potentially injurious exposure of any person to electronic product radiation as a result of the manufacturing, testing, or use of an electronic product.”

  • If there was no exposure, then I would not recommend that a manufacturer send an ARO Report to FDA.

  • If an exposure exceeded the MPE, then yes that is potentially injurious and the manufacturer is required to report the number of persons involved, adversely affected, or exposed during the accidental radiation occurrence, and the nature and magnitude of their exposure and/or injuries. The ARO Report should also include any actions, if any, taken by the manufacturer to control, correct or eliminate the causes and to prevent reoccurrence.

With regard to when the Report has to be submitted, the regulation says "immediately report" in 21 CFR 1002.20(a). Manufacturers should not wait until they have all the information we ask for in the ARO regulation, but should send in as much as they have initially and then supplement the report when additional information becomes available.


ADDITIONAL INFORMATION FROM ANOTHER FDA OFFICIAL

I would supplement the procedure [above] with the addition: “report the ARO immediately” even if you don’t have the information about the exposure. Any exposure is potentially hazardous until you have the data to show it did not exceed the MPE. Also, even [less than] MPE level exposures are potentially injurious with they occur to someone operating equipment that needs their full attention (pilots, drivers, boat operators, etc.)

All of the aircraft illumination incidents are AROs that are potentially hazardous and in many cases below the MPE. We don’t get ARO Reports for them because the laser product manufacturer is unknown unless the perp is arrested and the laser seized. Remember an FDA lawyer from OCC, I think, said the collateral hazards also count as laser hazard if they could happen as a result of a laser exposure (meaning loss of control of a vehicle or a crash).

  
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Page 3 of the 5-page FDA Accidental Radiation Occurrence Report form. ILDA has stored the June 2014 version which you can download here; you also may be able to get the latest version direct from the FDA website here.

In the United States - State level


Some states may have requirements for laser incident notification, but ILDA has not researched this to the state level.

In Germany


According to information received by ILDA, in Germany it is not required to report incidents where a laser came close to, but did not expose, a person. The information added, “in Germany there is no authority such as the U.S. FDA that monitors the market.”

However, if someone was harmed or if damage occurred, the police must be informed. The people in charge would be held legally responsible and liable in case of non-compliance with laws and regulations.