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US: UPDATED - FDA wants to allow only red laser pointers, calling all other colors "defective"

On October 25 2016, the U.S. Food and Drug Administration proposed to designate all laser pointers that are not red as “defective.” This designation would prohibit U.S. sales of green, blue and other non-red pointers and would make it easier for FDA to control and seize imports of such lasers.

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FDA’s primary concern is green lasers’ interference with the vision of vehicle operators including pilots. Green lasers are involved in over 90% of incidents where pilots reported to the Federal Aviation Administration (FAA) that they saw or were illuminated by laser light during a flight. (The charts below were added in January 2017 after the 2016 FAA final numbers came out.)

FAA 2016 reported laser colors pie chart - 0600w

FAA 2016 reported laser colors pie chart nanometers - 0600w

FDA is also worried about blue lasers which can have greater visibility to night-adapted eyes than red lasers of equivalent power.

Thus FDA is applying the “defective” label — giving them added authority over potentially injurious products — because of what they consider to be a well-known, established public safety hazard to operators of vehicles, aircraft and watercraft.

What FDA is trying to accomplish

FDA has two main goals:

     1) “Turn back the clock” to the 1990s and early 2000s when almost all laser pointers were red. According to the agency, red light has the least interference with pilot vision, compared to equivalent-power green beams which can appear up to 28 times brighter. During this period there were dozens or low hundreds of reported laser/aviation incidents per year, compared with 7,703 incidents in 2015 and 7,442 incidents in 2016.

     2) Make it much easier for customs and law enforcement to identify illegal laser pointers simply by their color. Red and orange-red laser pointers would be permitted; all others would be prohibited for general sales.

In addition, FDA sought to address requests from legislators including Senator Chuck Schumer (D-NY). After high-profile incidents, lawmakers have written to FDA, asking for a ban on green pointers due to their vision-blocking abilities being a risk to pilots and passengers.

Who would be affected

FDA’s proposed color-based prohibition would only affect the manufacture, importation and sales of laser pointer products introduced into commerce. Although pointers fall under the FDA’s “surveying, leveling and alignment” (SLA) control, only pointers as defined by FDA would be restricted to red. Standard SLA equipment would not be affected — they could use any color beam.

Individuals such as hobbyists who manufacture their own laser products for their personal use would be free from FDA laser product regulations. This is because such individuals would not be considered manufacturers by FDA.

Since federal law cannot control individual use or misuse, states and localities could impose their own regulations. (A few states and localities already have their own restrictions on use and/or possession; these are not currently based on the color of the laser.) One benefit of FDA’s proposal is that any new state and local laws could “piggyback” on FDA’s color-based restrictions. That would make it easier for local law enforcement to use color to easily identify whether a person possessed a prohibited or permitted laser.

FDA’s proposal and rationale was stated in draft amendments presented October 25 to an FDA advisory panel known as “TEPRSSC”.

What colors would be affected

The agency proposed amending the federal laser performance standards 21 CFR 1040.10 and 1040.11 to limit laser pointer colors. Wavelengths from 610 nanometers (orange-red) to 710 nm (deep red) would be permitted for pointers. All other colors including violet, blue, cyan, green, yellow and orange — any wavelength from 400 nm (deep violet) to 609 nm — would not be permitted.

The maximum power level for laser pointers would remain at 4.99 milliwatts.

Why FDA believes non-red lasers are “defective”

FDA believes their action is necessary due to the underlying safety hazard from laser pointer visual impairment. The agency’s submission stated “The hazard from flash blinding is substantially reduced when laser pointers emit red/orange wavelengths at 615 nm or longer. The hazard from laser aircraft illuminations would be effectively eliminated if green and blue laser pointers were not available. Colors at 615 nm and longer, viewed with night adapted vision, are only 1.4% as bright appearing as green at the commonly manufactured 532 nm wavelength.”

The agency would gain authority to do this by declaring non-red pointers as “defective.”

Regulation 21 CFR 1003.2 says a defective electronic product “emits … radiation unnecessary to the accomplishment of its primary purpose which creates a risk of injury … to any person.”

This “defective” declaration gives FDA the strongest possible power to stop manufacture and importation of non-red laser pointers. For example, manufacturers could be required to repair, replace or reimburse a purchaser for a defective product.

FDA feels that 21 CFR 1003.2’s requirement for “risk of injury” has been well-established by groups such as FAA and the Air Line Pilots’ Association. In addition, control efforts such as the 2012 laser pointer misuse law have proven ineffective; laser incidents reported to FAA have more than doubled from 2012 to 2016.

And, FDA addresses the “unnecessary” requirement in 21 CFR 1003.2 by noting that to function as pointers, handheld battery-powered lasers can use red light and do not need to use other colors such as green or blue.

Exceptions for persons needing other colors

FDA’s written proposal did not address the apparent paradox that individuals could still possess and use non-red laser pointers — since FDA has no authority over individual use — but that the agency would be prohibiting the manufacture of such pointers.

A TEPRSSC panel member asked FDA to look into this matter, stating that there were applications such as amateur astronomy where colors other than red, or powers greater than 5 mW, would legitimately be necessary.

New definition of “laser pointer”

In its proposal, FDA sought to establish a new definition of laser pointer:

“Laser Pointers may be defined as handheld laser products designed for battery-powered operation that are manufactured, designed, intended or promoted to provide illumination, designation of a target or point of origin, or sighting, with no associated technological or scientific purpose for the laser’s emission. Laser products are not excluded as laser pointers when used for visual entertainment, vision disruption or startle or novelty purposes.”

The agency did state that this would include sighting laser products such as weapon sights and bore sights.

About the TEPRSSC panel, and what happens next

In the October 25 submission, FDA was asking the agency’s Technical Electronic Product Radiation Safety Standards Committee for advice and consultation on the feasibility, reasonableness and practicability of making changes in laser and other radiation safety proposals.

The 15-member TEPRSSC committee had 11 persons in attendance, from industry, government and the general public. This was the first meeting of TEPRSSC since 2003.

FDA may modify its proposal based on input from TEPRSSC.

The next step — which could take weeks or months — is for FDA to publish the proposed regulations in the Federal Register. There would be a standard 90-day period for public comment. Based on the comments, FDA may make additional changes (including perhaps dropping part or all of the proposed regulations) before issuing a final rule.

The full text of the 60-page FDA presentation is here. We have highlighted selected laser pointer and consumer laser information in yellow. In addition, we have transcripts of the first day and the second day of the TEPRSSC meeting, again, with selected laser pointer and consumer laser discussions being highlighted.

A 10-page paper, “
FDA’s Proposed Change to the Regulation of Laser Pointers” gives a detailed discussion of the problem, the proposal and the reaction. It includes 66 footnotes with references to other relevant resources. The paper was co-written by Patrick Murphy of LaserPointerSafety.com and Capt. Daniel Hewett of the U.S. FDA CDRH. It was presented March 21 2017 at the International Laser Safety Conference in Atlanta.

Commentary from LaserPointerSafety.com: This is an interesting proposal; as of October 28 2016 we are not aware of any countries or jurisdictions that prohibit laser pointers based on color. There are countries and jurisdictions which have a lower power limit (1 mW) than the U.S. limit of 5 mW. There are also countries and jurisdictions with restrictions on personal possession and/or use of laser pointers. But none of these appear to be color-based. More information on laws and restrictions can be found in the pages on international laws, on U.S. laws, and on laser pointer permits.

UPDATED January 13 2017: Added charts showing the color of laser illuminations in the U.S., and added the number of FAA-reported incidents in 2016 (7,442).

UPDATED May 8 2017: A quote from a 2008 police aircrew interview has relevance to the effects of different colors: “In the past it tended to be the red lasers, which didn’t seem to be so quite so bright but the green ones they’re getting hold of now, they blind you for a few seconds if they catch you in the eye and they also, if they get them inside the cockpit, they turn everything green and make it difficult to see the instruments. So they are a hazard”. The quote is in this video, and starts at 19 seconds.