A comprehensive resource for safe and responsible laser use
What happens if you break the rules? (For those selling laser pointers)
The following is a continuation of the page Federal rules for those selling laser pointers in the U.S.
The information on this page comes from an experienced laser user. It is presented here at LaserPointerSafety.com to provide a starting point for guidance. Do not rely on this for legal advice -- you would need to independently investigate and evaluate the statements below. One starting point is the website for the U.S. federal laser safety agency, the FDA’s Center for Devices and Radiological Health (CDRH).
Background to the advice
In April 2009, a person selling laser modules and pointers on the Internet received the following letter. The CDRH stated that the lasers were above the 5 milliwatt limit for the products being sold, and that no laser product manufacturer reports had been filed. The person was given 30 days to meet the certification requirements or otherwise satisfy CDRH.
Click here for a full-size downloadable PDF of the letter: cdrh-letter
After talking with the CDRH contact on the phone, the person decided to close his website and stop sales. He took this course of action partially because his primary business background was not in laser equipment sales. Obviously, if a company’s primary business was to sell laser modules and products, the company might well decide to “clean up” their procedures and comply with CDRH rules and regulations.
The text below (not in italic) was written as advice to the person who received the CDRH’s letter.
What to do if you receive a letter like this
For the record, I do not think there is any need for any non-varianced entertainment laser or a laser pointer over 4.95 mW outside of your basement lab. High power pointers have created a bad rap for the laser show community when IDIOTS aim them into airspace. I have been in the past held a variance and have submitted many product reports. I've done more professional laser work since 1988.
This is strictly for the aid of this fellow who has crossed paths with the CDRH. And to give many of you a heads up on how to avoid a letter like this.
Consult a professional in the laser regulations field
An ordinary civil law lawyer will not be able to really help you effectively. You’re into administrative law, and its a different animal then most lawyers practice. Also, do not go through this with out professional help. Your in deep trouble as you know.
There are at least three major outfits that can guide you through this. Remember, law enforcement is not always required by law to tell the truth, so you need a consultant. You can be handed over to a US Attorney or you may find yourself given a fine without going to court. It depends on a lot of issues beyond your control. If I remember correctly it can be as bad as $250,000 or six months in jail. I doubt you rate jail, but I am aware of one fellow that made laser power supply kits for HeNe’s who ended up with $20,000 in legal costs and an $8,000 fine.
This is by no means a complete list, however I have met Casey Stack of Laser Compliance several times and I have met various Rockwell employees through ILDA, they are both world class.
The FDA may come visit
You could expect a possible visit from a FDA specialist. They have a Federal badge and while they are not going to arrest you on the spot, it can be a grueling inspection. (I don't remember my local one ever having nor desiring arrest authority, nor did he carry or is authorized a firearm). He does wield a mean pen. What it will be, is a finding of fact sort of process. How to handle this possibility is between your lawyer, your consultant, the CDRH and you. I don't know how to advise you because I'm not a lawyer or compliance specialist, and because I've never been in violation.
Don’t do anything stupid like dumping your gear or hide any paperwork you have. Federal administrative fines are supposed to be proportional to the income of the person fined and the severity of the issue at hand.
Decide how to fix the situation
You will be asked to submit some form of remediation plan. It may be anywhere from just cease-and-desist, to a recall sent to all your customers, to paying a fine. If things don't go well, you get handed to a US Attorney for prosecution. This is why you need contact with a laser safety professional.
When do you become a “manufacturer” according to CDRH?
A good rule is if you are selling more than one of something, or to more then one customer, you are “manufacturing”. You then fall under CDRH jurisdiction.
Even a raw diode, a used diode, and certain parts such as collimation optics, barrels, laser diode drivers, laser show projectors, etc. then YOU need to be registered as a manufacturer, by filing a "Manufacturer's Report" if your doing more then a few. eBay is a different can of worms, and can be a grey area.
There is no federal law preventing you from owning a kilowatt class laser in your basement. There is no law for transfering it to another American if you didn't manufacture it and if you are only selling one. There are some state rules about registering lasers, like in Texas and Arizona and other states.
However, if you use the laser for making money, or in public, or export it, or expose your employees to it, then rules come into play.
For laser shows in public you need a variance as a demonstration laser device. That is a whole different topic. Laser demonstrations and shows require filing reports on the projector equipment, and a separate report on the show (how the equipment is used).
Class 3R (a.k.a. IIIa) lasers are more heavily regulated
The line really gets drawn at Class 3R (IIIa), i.e. once you go above the 5 mW limit on Class 3R (IIIa) lasers. For anything over 5 mW, it’s a safe bet you need a variance as well as a Manufacturers Report filed if you make your own gear. No exceptions. What you do in your own basement is your business, but if you introduce anything over 5 mW to the public or outside your basement lab, its a whole new set of rules. Oh, and yes, popping diodes out of old DVDs and reselling them is manufacturing.
FAA requires all pilots to report any laser they see, even if terminated, and lasers into airspace is a whole new can of worms, called FAA 7400. I've had pilots report shows I've worked on, even when a NOTAM is out for the show. The FAA does check it out in real time, even if they need a local cop to do it. Even a legal pointer can interfere with a aircraft, JUST DONT DO IT.
Back to the Manufacturers Report.... It’s actually quite easy, its free, and nowhere near the pain in the neck many people claim it is. The people that claim it is hard are lazy or don't want to request the data on how to do it from CDRH. CDRH is very proactive, they will NOT instantly tell you something like "You cant do that" if you call for help. And they are not going to come visit you just because you called, unless you request a Regional Electro Optical Specialist to come see you.
I'm not going to go into a huge list of requirements, they are spelled out quite simply in a FDA publication. But... for a pointer, you’re probably talking two to four pages of text and drawings , if that much. And a simple checklist. Like a medical device, you need to do quality control on your products, IE confirm as you make each device that it matches the checklist you submitted.
Yearly report also required
You also need to submit a yearly report stating how many devices you sold, and if there were changes, deficiencies, returns, and what the power levels were, etc. You keep the records for 7 years, and if a EOS decides to visit you, you whip out your notebook with records and any correspondence you have received and your done. The recordkeeping is NOT to torture your customers, it is to protect them by allowing for a recall if the product is dangerous.
It's actually pretty painless if they visit you. If they find minor errors, you submit a correction report. NO BIG DEAL.
Why the Food and Drug Administration administers something that is neither a food nor a drug
Why is it the FDA that rules over lasers? My usual sarcastic remark is “Would you rather deal with agencies such as the Nuclear Regulatory Commission or the Bureau of Alcohol, Tobacco and Firearms?” The real answer is that non-ionizing radiation is in the FDA’s area. The same division that handles lasers also handles light sources, X-rays, radio wave based medical devices etc. Since non-ionizing radiation mainly affects tissue, its a medical thing and falls to the FDA. Lasers get treated as a simpler subset of the medical device rules, and hence the medical manufacturing report style and inspections and record keeping. Congress assigned non-ionizing radiation to DHHS in the late 1960s.
One more thing, the myth that small lasers are not dangerous. Class 2 (II), up to 1 mW, is based on the idea that your blink reflex will protect you from a brief exposure. Class 3R (IIIa) is based on the fact that hopefully powers under 5 mW will not harm you more then 1 time in 99,999 exposures. Medical aiming beams in the eye go up to about 3 mW, but if your eye doctor uses more then say 0.5 mW, it’s damn painful. Most eye surgeons start to get real results at 150-200 mW, but can often see effects at 50 mW. Why risk exposing ANYONE with a powerful pointer or lab laser? Think about it -- that’s why the rules exist.