FDA proposes ban on handhelds >5mW

[pmurph5]

Encap, when Livinloud wrote "Anything over 5mW is already illegal", you replied "Exactly", so I assumed you meant you agreed with the statement.

FDA's regulatory authority comes from 21 CFR 1040.10 and 1040.11. In these regulations, FDA is given power over all laser products -- the physical device or equipment -- but only over three laser uses: medical, demonstration (including laser light shows) and "surveying, leveling or alignment".

• As far as the product goes, as long as a manufacturer's product has the required safety features and paperwork, it can be sold and marketed in the U.S.
  
• The exception comes when a product is sold and marketed for medical, demonstration (laser show) or "surveying, leveling or alignment" (SLA) purposes. For the latter two, FDA can require that the product be under 5 mW.

As I wrote before, you can search through 21 CFR 1040.10 and 1040.11 and not find the word "pointer", "handheld", "portable", "battery-powered", etc. So how did they come to regulate lasers used for pointing? And why are they now trying to regulate any handheld battery-powered laser?

FDA has tried to increase its control of consumer lasers in two "waves".

The first wave, in the late 1980's, somehow convinced manufacturers and then the public that lasers used for pointing were demonstration and/or SLA lasers. I filed two Freedom of Information Act requests to find out what regulations, guidance, letters, internal memos or other documents stated this policy. So far, FDA has not come up with any documentation (!).

The second wave started around 2010 and as Encap states accelerated last year. The policy interpretation again is murky. There are two tacks that FDA has taken in this wave:

• One tack is based on part of the 21 CFR 1040.10(b)(39) definition of an SLA laser: "Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement." FDA feels that because the word "point" is in there, any laser used for pointing is an SLA laser. (I disagree since the pointing is being done to highlight or call attention to something at a location. It is not being used to determine its position by taking angular measurement.)
  
• The other tack is newer. This is what FDA explicitly is stating in its May 5 proposal. This tack first claims that SLA lasers have features such as being compact, battery-powered, portable and handheld. Then by a breathtaking leap of logic, FDA concludes that lasers with these features are SLA lasers which they can control.

The trick is that if everyone believes FDA, or is cowed by them, or doesn't want to fight back, then -- just like what happened with laser pointers -- their claims will become "accepted reality" and everyone will start acting like FDA has the power -- which they don't -- over compact, handheld, battery-powered, portable lasers over 5 mW.

What is new in 2014 is that FDA isn't too sure of themselves. As I said before, if they already had this authority, they wouldn't have to have put out for public comment their May 5 proposal.

To conclude, there is a difference between the authority FDA is given in 21 CFR 1040.10 and 1040.11, and the authority they assert. 25 years ago, they slipped in their assertion about pointers, which everyone at the time assumed was correct. Now they are trying something similar with this SLA interpretation, to expand their authority. In my personal view as a private citizen, FDA is doing this based on a completely incorrect interpretation.

 

[mortuus]

not to worry all laserbtb lasers are FDA approved at least... lol... or are they.

 

[Atomicrox]

IMHO the FDA is trying to create a completely nonsensical interpretation in order to regulate something they're not supposed to.

If I were a US citizen I'd find out what the proper course of action is and do what's needed (maybe file a claim to the government department in charge of handling law interpretation/abuse of power issues?).

 

[Hemlock_Mike]

Do I smell a camel near my tent?
He is heading this way.
HMike

 

[Encap]

Encap, when Livinloud wrote "Anything over 5mW is already illegal", you replied "Exactly", so I assumed you meant you agreed with the statement.
What is new in 2014 is that FDA isn't too sure of themselves. As I said before, if they already had this authority, they wouldn't have to have put out for public comment their May 5 proposal.

To conclude, there is a difference between the authority FDA is given in 21 CFR 1040.10 and 1040.11, and the authority they assert. 25 years ago, they slipped in their assertion about pointers, which everyone at the time assumed was correct. Now they are trying something similar with this SLA interpretation, to expand their authority. In my personal view as a private citizen, FDA is doing this based on a completely incorrect interpretation.

pmurph5-- Sorry for the confusion --is my fault, You are right I said "Exactly" in response to "illegal" by livinloud, which was way to broad--what I meant was importing laser pointer or handlhelds >5mW is already prohibited and sales of lasers > 5mW as a business >5mW prohibited-- without 100% of the required paperwork and/or variance permitting same-- already for quite a while, so not much is changed by the draft guidance document.

I do understand your points that the language and catagories FDA has chosen to express and assert it's authority in rules, regulations, and guidance documents is confusing and may not be the best choices of English making what they mean not clear some of the time.

FDA maintains they have always had the authority over all "radiation emitting electronic products" including all lasers as one of their defined and mandated purposes by Law and they say so in many places straigthforwardly and simply. New powers are not needed--they already have the powers--you can argue about how they assert, express, and implement their powers and the semantics of the specific lanugage they use or don't use. I guess my point is that by Federal Law FDA has the responsibility and authority/power to make the rules, regulations, definitions of what is what, and to enforce their view--- meaning what they say is what flies and is a constantly evolving thing implemented is various ways.
Examples:
"FDA's Authority. The FDA has the authority to regulate all kinds of lasers." see: Illuminating Facts About Laser Pointers

Definition of Electronic Product Radiation "(1) the term "electronic product radiation" means - (A) any ionizing or non-ionizing electromagnetic or particulate radiation" see: Does the Product Emit Radiation? The also say "Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation. X radiation (x-rays), microwaves, radio waves (radiofrequency (RF)), laser, visible light, sound, ultrasound, and ultraviolet light are a few examples of the many types of radiation-emitting electronic products." here: Getting a Radiation Emitting Product to Market

It is important to note FDA clearly also says as of 8 April 2014, "FDA’s authority is over the manufacturers of laser products. These products must meet a federal standard for the amount of radiation they can emit and must be properly labeled. FDA is working to identify manufacturers of overpowered green, blue and violet laser pointers and other illegal laser products and will take action to prevent unsafe products from being sold in the United States. If illegal products are imported into the U.S., they may be refused entry, returned to the seller, or destroyed." here: Consumer Safety Alert: Internet Sales of Laser Products

 

[Atomicrox]

Definition of Electronic Product Radiation "(1) the term "electronic product radiation" means - (A) any ionizing or non-ionizing electromagnetic or particulate radiation" see: Does the Product Emit Radiation? The also say "Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation. X radiation (x-rays), microwaves, radio waves (radiofrequency (RF)), laser, visible light, sound, ultrasound, and ultraviolet light are a few examples of the many types of radiation-emitting electronic products." here: Getting a Radiation Emitting Product to Market

Every single atom in the universe emits electromagnetic radiation. Therefore the FDA has authority over every single thing. QED.

 

[Encap]

Every single atom in the universe emits electromagnetic radiation. Therefore the FDA has authority over every single thing. QED.

They are a bit more specific than every atom in the universe.
That was a small sample of what FDA says. They go on to explain in more details what they mean by "electronic products that emit radiation" Read about it here: : Does the Product Emit Radiation? A part of which is below:
"(1) the term "electronic product radiation" means - (A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product;
(2) the term "electronic product" means (A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and
(ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation; 1.the term "manufacturer" means any person engaged in the business of manufacturing, assembling, or importing of electronic products."

 

[The Lightning Stalker]

Handheld lighting is big business. Someone must be lobbying for tighter controls on lasers because
they're scared to death of losing the handheld lighting sector to laser based illumination sources. They
have been bankrolling LEDs and would be terrified of losing their investment. The idea of coupling blue
lasers to phosphors for producing white light is already being talked about in the automotive sector. A
small inexpensive high intensity flashlight based on this technology has the potential to change the
playing field. There a bunch of big corporations who would stand to lose, such as Maglite, Rayovac,
and Cree just to name a few. How do you think hemp got banned back in the 1930s? It was because
of the oil companies lobbying to get rid of competition against their new synthetic fibers and
composites. History has a funny way of repeating itself.

There are hundreds if not thousands of incidents of people getting hurt by firearms every single day. Yet
we don't see guns getting banned. One big reason is there is a huge weapons industry lobbying and
protecting its interests. There are what, maybe 1-3 laser incidents a week in the entire country. The
laser industry is tiny in comparison with the battery/flashlight/LED industry. It's also mostly a foreign
influence since there are very few laser diodes actually being produced inside the US. So, if it isn't the
flashlight/battery/LED industry, someone is lobbying HARD for new laws against lasers and it's going to
keep us in the dark ages, literally.

 

[ScottW]

Someone must be lobbying for tighter controls on lasers because they're scared to death of losing the handheld lighting sector to laser based illumination sources.

Perhaps... Yet I have to believe that most of those companies would not want to see additional regulation of something that they, themselves, might one day want to manufacture as part of their own business.

I really suspect the aviation industry is more involved in the funding. In the 2008 election cycle, U.S. Airlines donated $3.7 million to politicians at the federal level, and spent $31 million on lobbying. That's just the major airline companies -- it does not include the $millions spent by aviation manufacturer and service companies, nor all the groups like AOPA and ALPA, all of which have PACs funded by their members. Obviously their money primarily influences things like aviation regulations, safety rules, taxes, etc., but you can bet more than a few were whispering into politicians ears about "cracking down" on lasers as a way to reduce aircraft illumination incidents.

This expanded interpretation isn't just an unsolicited power grab by the FDA. The FDA is getting pressure (and support) from aviation groups, the FBI, politicians, police and the military to "do something" about the proliferation of high powered handhelds. And all of them are using the media to scare the public into thinking more restrictions are the only way to keep death and destruction at bay. "We're the government, and we are here to protect you."

I am also concerned about the Proposed FDA Amendments issued last June, for which a final rule will be issued in June-2014. Among other things, it includes this gem:

FDA is proposing to amend § 1040.10(a)(3) by adding a new paragraph (iii) as a means of addressing uncertified, unreported complete laser systems that are sold as components. FDA has observed that some manufacturers and distributors are marketing what are actually complete laser systems as components or original equipment manufacturer (OEM) parts. New § 1040.10(a)(3)(iii) would require that the seller document that the purchaser meets the definition of manufacturer in § 1000.3 (21 CFR 1000.3) or that the purchaser is excluded from applicability of the standard in accordance with § 1040.10(a)(1) or § 1040.10(a)(2). The provision also would require the seller to maintain such documentation as specified in § 1002.31 (21 CFR 1002.31).​

That appears to directly affect some members and well known companies represented on this forum who currently sell "kits", "unassembled" lasers, or perhaps even those who sell all the individual parts (i.e., hosts & diodes) necessary for a build.

I urge everyone here to submit comments on any proposed rules during their comment periods, and to write their members of congress as appropriate. Unfortunately, "laser hobbyists" are a comparatively small voice, without $Million PACs and lobbyists, so despite our best efforts we are likely to see more restrictions, additional customs enforcement, and perhaps outright bans in a few years.

Personally, I have started my backup plan, which is buy as much as I can afford as fast as I can reasonably afford it. I have a Jetlasers TI-B arriving today, and a PL-E coming in a few days!

 

[vortish]

First off Laser show.. Have been coming under a lot of attention as of late because kids are going to raves that have laser shows that are over the 5 mw limit and having issues with seeing and or epileptic fits.. Grand Coulee Dam's laser show is over 1 watt for the blue green and red lasers they use but you do not see the dot till its on the dam face and it makes shapes and things.. besides its a federal dam and the laser show is run by the government. The second thing is Big Brother is trying to take away our freedoms granted to us by the untied states constitution. I did not give up ten years of my life to fight for my country to let my freedoms be taken by a abusive government. Politicians have gotten away from what they are suppose to be doing. Instead they are lining their pockets with our tax dollars and screwing the american public. It just one more way for them to tell us what to do. Every day in this country more and more of our civil rights are being taken away from a government that want the poor to stay poor and the rich to stay rich. I am not a democrat or republican. I am a conservative and one that believes in less government and term limits. I had family members lose their lives defending our nation and by god I am not going to let their sacrifice be in vain because of these corrupt politicians we have today. I have signed three hundred petitions against the us government and one that is calling for the impeachment of Obama. The arrest of Bill Clinton and George W Bush. These three crooks need to be in Jail for what they have done to the American People. Term limits and less government need to be done only way to do that is get all the friggin crooks out of DC

I will get off my soap box now thanks

 

[ScottW]

Hey Vortish! Don't hold back, tell us how do you really feel? Lol. I'm right there with you - some politicians may be less crooked than others, but they're all crooks.

Back to the main topic... I would seriously ask the question, "What can we do about the FDA trying to overreach on laser regulations?"

Certainly we can submit public comments when allowed, and write our members of congress. And we can vote, but the choices are "limited". All of that is unlikely to have much impact, because our numbers are small.

Are there any kind of lobbying or advocacy groups for laser hobbyists and the manufacturers who supply us? Seems like even the Chinese companies would see the value of "banding together" and forming some kind of lobbying group that could TRY to counter some of the chorus asking for handhelds to be banned. Is anything like that happening?

 

[LSRFAQ]

This is PROBABLY not about getting a new power to enforce. It is PROBABLY about reclaiming a power the government ceded or waved a decade or so ago to reduce paperwork.

Ie the memo where very low power pointers were waved from paperwork requirements. Demand for something that never existed before, was high, and the agency was flooded with paperwork.

Back then no one could envision the massive growth in diode power, which was bottlenecked at a few milliwatts for decades.

Don't expect the memo to save pointers, it clips power at less then the old Class IIIA, ie 4.95 mW.

BTW Grand Coulee Dam's show is in excess of 20 watts and goes through the same varience process any other large outdoor display goes through. It's built , programmed, and maintained by contractors, and the contract comes up for public bid periodically. You can look for the requests for bid submission in the Federal Register.

Steve

 

[Marco Polo]

Meanwhile, Celebrex is still killing people. Thanks for protecting us, FDA, you waste-of-a-paycheck shitbags.