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US: Laser show company has variance revoked for unauthorized audience scanning
A laser light show company had their FDA variance revoked for “a very significant public safety hazard”. This is the first time LaserPointerSafety.com is aware of such a revocation due to unsafe laser light shows, since the variance process began in the late 1970s.
On July 24 2014, the Food and Drug Administration sent a letter to David Fleenor of Epic FX, Inc. of Phoenix, Arizona. It stated that videos posted on the epicfx.com website “documents audience scanning with Class IIIb and/or Class IV lasers. Although much of the audience scanning was done with fanned beams, your projector is not designed nor reported for safe audience scanning. Your variance prohibits audience scanning. Any laser beams projected into the audience directly or indirectly is considered audience scanning. This is in violation of Condition 5 of your variance.” [The page has since been removed, and returns a 404 error.]
On July 24 2014, the Food and Drug Administration sent a letter to David Fleenor of Epic FX, Inc. of Phoenix, Arizona. It stated that videos posted on the epicfx.com website “documents audience scanning with Class IIIb and/or Class IV lasers. Although much of the audience scanning was done with fanned beams, your projector is not designed nor reported for safe audience scanning. Your variance prohibits audience scanning. Any laser beams projected into the audience directly or indirectly is considered audience scanning. This is in violation of Condition 5 of your variance.” [The page has since been removed, and returns a 404 error.]
The FDA letter also noted that “people on the floor could put their arms in the beam path,” violating a requirement that beams be kept 3 meters vertically from a surface on which people can stand (Condition 6 of the variance).
On the company’s YouTube channel, another video clip (since made private) shows a September 2013 laser light show with “many instances ... where the audience is scanned with laser beams or safety distances are not maintained. This unsafe and noncompliant operation of the laser light show is in conflict” with the company’s July 2013 report submitted to FDA.
The FDA letter, signed by Mary S. Pastel, ScD, Deputy Director for Radiological Health, noted that the company could respond within 15 days to deny that the “alleged failures to comply” took place. The company could also re-apply for a laser light show variance, and would need to describe corrective actions.
FDA allows beams to directly scan the audience if projectors “specifically designed, reported, and certified for audience scanning” are used, and if the variance application sets forth “compliance testing procedures [used] at your facility and on-site.” Epic FX did not use such a projector, according to their variance applications prior to the July 24 2014 FDA letter.
From the FDA letter revoking Epic FX’s variance 2013-V-0903; an official copy is also available from Regulations.gov. The revocation was discussed in more detail on a PhotonLexicon.com forum thread called “Ever wonder if the Laser Police Watch Youtube.” Thanks to two ILDA Members for bringing this to our attention.
On the company’s YouTube channel, another video clip (since made private) shows a September 2013 laser light show with “many instances ... where the audience is scanned with laser beams or safety distances are not maintained. This unsafe and noncompliant operation of the laser light show is in conflict” with the company’s July 2013 report submitted to FDA.
The FDA letter, signed by Mary S. Pastel, ScD, Deputy Director for Radiological Health, noted that the company could respond within 15 days to deny that the “alleged failures to comply” took place. The company could also re-apply for a laser light show variance, and would need to describe corrective actions.
FDA allows beams to directly scan the audience if projectors “specifically designed, reported, and certified for audience scanning” are used, and if the variance application sets forth “compliance testing procedures [used] at your facility and on-site.” Epic FX did not use such a projector, according to their variance applications prior to the July 24 2014 FDA letter.
From the FDA letter revoking Epic FX’s variance 2013-V-0903; an official copy is also available from Regulations.gov. The revocation was discussed in more detail on a PhotonLexicon.com forum thread called “Ever wonder if the Laser Police Watch Youtube.” Thanks to two ILDA Members for bringing this to our attention.