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Thread: Laserworld/RTI and US Laserists

  1. #11
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    Thumbs up Clarification on when a variance is required

    Sorry for being late to jump in on this thread (been busy!), but I did want to clear up one misconception:

    Quote Originally Posted by DanG View Post
    There is no clear line about when a variance is required
    Actually, there is a very clear line. The FDA derives it's authority from it's congressional charter, which authorizes it to regulate COMMERCE. So as long as the laser product is (or will be) involved in COMMERCE in some fasion, then CDRH regulations apply.

    So - build a projector and use it in your basement? No variance required.

    Build a projector and use it for a halloween display in your garage for the neighborhood kids? No variance required.

    Build a projector and use it in a nightclub? BOOM! Commerce is involved and now you need a variance for the show *and* you need a manufacturer's variance in order to certify that the projector you built is compliant with all federal regulations. Note that even if you are doing the actual laser show for free, because it is a place of business and it is reasonable to expect that people will come to see the show (and buy drinks in the process), commerce is still indirectly involved and CDRH rules must be followed.

    my perspective is that if you are in your own home for your own private enjoyment, that does note require a variance.
    Yup. As stated above, no variance is required to do this.

    HOWEVER, if you *purchase* the projector, then you have to have a variance, since the *purchase* falls under the commerce clause. You can only avoid this if you build the projector from scratch yourself. Even if you buy it with the intention of only using it in your house, the fact that you bought it means you need the variance. (Though you could let it expire once you have the projector in your hands.)

    Note also that importing a projector from China (or any other country) requires you to fill out a customs declaration form (FDA form 2877) which specifies the plan for either bringing the projector into compliance (under a manufacturer's variance), sending it back out of the country, or destroying it. Failing to submit this paperwork can result in your projector being seized by customs officials at the border.

    As soon as you start doing shows outside your home, I would suggest having a variance in place.
    100% agree. Even if commerce isn't involved, the local authorities (especially your local fire chief) can make your life hell if you don't play by the rules. Having your variance is the first step in demonstrating that you know what you are doing.

    You could do a show say at a worship service for free, and that would still require a variance.
    Technically at a church there is no commerce (churches are tax-exempt), and I know several operators who do church shows without a variance, despite the fact that this is not recommended. I've spoken directly with the CDRH about this exact issue in the past, and while they *really* didn't want to admit it, eventually they did go on record stating that a church show would be out of their jurisdiction.

    Even so, it's a bad idea. You can still be sued, and not having a variance will make you look like an idiot in court. But it's not legally required in this case.

    Use your common sense, and just plan to get one. there's no reason not to, its free, and you'll learn a TON in doing to the work to get it.
    This is perhaps the best advice in this thread. A variance is not something to be fearful of. It's a tool that helps you perform your shows safer. It also demonstrates a basic knowledge of laser safety, and that always looks good.

    Adam

  2. #12
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    So, I have three homebuilt projectors -- two I bought from Buffo and one homebuilt by Saltyrobot but in a Laserworld case.

    How would I go about getting a variance with this kind of equipment? The only shows I plan to do are in or at my own house or maybe a private (outdoor) pool/birthday party, etc. Never in a commercial environment.
    Last edited by HankLloydRight; 11-29-2017 at 18:57.

  3. #13
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    All the projectors would need to be certified as compliant by someone who holds a current laser product manufacturer's variance.

    At a minimum, that would include ensuring all units have the proper labeling and safety features installed (beam attenuation system, safety interlock, emission indicator, keyswitch, etc), filing a laser product report with the CDRH for these units (or at least modifying the projectors to be compatible with an existing laser product report already on file with the CDRH), completing the proper test paperwork to verify compliance under the QA/QC requirements spelled out in the product report, and re-labeling them as being a new product with the company name of the person who certifies them.

    Then you would need to submit a laser light show variance application to use these newly-certified products in a commercial application.

    In short, this is a lot of work! It can be done, but if your ultimate goal is to use a projector commercially, you are better off purchasing a legal unit right from the start. But if your plan is only to use it in your home, then building a home-made unit (or buying one from a friend) is OK.

    Adam

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    Let me clear up something guys - a "commercial" environment is not required to trigger the requirement to have a variance. FDA has been pretty consistently clear about this over the past couple of years. The church distinction has been walked back - along with lots of other things that used to be passable.

    Adam is absolutely correct that FDA derives their power from the commerce clause, however this is why they have tortured the definition of a "manufacturer" to include people "manufacturing" shows. Any show that incorporates a "public" display - whether or not commerce itself is involved per se - can be regulated by FDA because the show is "manufactured" by a show producer.

    We had a detailed conversation about this at the ILDA conference and tried to flesh out where those gray areas were in commerce, public, private, etc. At the end of the day, it comes down to one's opinion, and more specifically, the FDA's opinion.

    Their touchpoint is public safety so any display which is accessible to the public, outside of your home, generally requires a variance. Inviting over kids to see a laser show may even count because the display can be accessed by the general public, even though it is in your garage. I would think that is a distinction they are unlikely to assert unless there is an injury event, but if there is, they would almost certainly classify such a halloween show as a public display. This is also why the church distinction was walked back - almost anyone can walk into a church service. It's a public display, and the fact that the show is being done for free really has no impact on whether the show is safe for the public to view.

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    D'oh! Just noticed the user-name swap. Sorry Dan - didn't realize who I was speaking with!

    That being said, I will also admit that my information comes from Dale and dates back to *before* the CDRH came up with the tortured "show manufacturer" definition you mentioned, so it may well be that they believe they can now claim jurisdiction over a non-commercial show.

    Although I also believe that this new definition has never been formally challenged, and honestly I think any decent lawyer could slay that one. But I also don't want to be the guinea pig!

    While I agree in principle that the CDRH should derive their power from a public safety standpoint, that is not the way their charter reads. And if it *is* the current position of the FDA that they are a safety agency, they really need to petition congress to change their charter.

    Adam

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    So am I reading that right? In order to get the variance completed you need to have someone who already manufactures laser equipment with a variance to approve of your home made laser? Or did I misinterpret?

    I am all for safety, stubbornly so, but that rule doesn’t seem geared toward safety. What malady is it preventing? Profit loss? It seems like it was lobbied by some big business in order to stifle competition. And all it does in my case is make it really difficult to have a couple friends over in my garage to smoke a joint and watch some lasers without some government entity knocking down my door (and I’m in a legal state so it ain’t for the weed).

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    Quote Originally Posted by ryanlightsitup View Post
    So am I reading that right? In order to get the variance completed you need to have someone who already manufactures laser equipment with a variance to approve of your home made laser?
    Typically if you build the projector yourself and want to make it legal to use in a commercial show, *you* file for the manufacturer's variance, *you* write and file the laser product report, and *you* certify that the projector you assembled is compliant. After all, you are the manufacturer!

    This is the path I went down with my projectors. It's a huge pain in the ass, and it took me the better part of a year, even with a paid consultant helping out. Note also that I don't sell my gear to others. I just wanted to be able to certify it myself.

    Alternately, you can hire someone else to do all this work for you. It's expensive, but it saves you from having to educate yourself on all the little details regarding laser product manufacturing and certification.

    I am all for safety, stubbornly so, but that rule doesn’t seem geared toward safety.
    The regulations were meant to apply to a company that wanted to start building products that contained lasers, since those products would eventually be sold to others to be used in public, or used by the original company on members of the general public. Thus, they had to apply to be a laser product manufacturer first. (Obtain manufacturer's variance.)

    Then they had to submit a laser product report that detailed how they were going to build the product, how the lasers would be incorporated safely into the product, how they planned to comply with the various requirements, and what sort of testing/quality assurance program they had developed to ensure they didn't screw anything up and put the public at risk with their new product.

    Then they could start building and selling laser products, so long as they adhered to the policies and procedures they outlined in the laser product report. Oh yeah, and if the products were laser projectors for laser light show use, then they would also need to ensure their customers had their laser light show variances from the CDRH before they sold them the laser projectors. (That protects the public against stupid/careless/reckless operators, at least in theory.)

    It seems like it was lobbied by some big business in order to stifle competition.
    No, more like the FDA was tasked with regulating a new and potentially dangerous product that was initially only used in medicine and scientific research. Read up on the Therac-25 to see what can happen when you don't have proper regulatory oversight on new medical equipment. Has the pendulum swung too far in the other direction? I would say yes. But the original idea is sound. The devil is in the details.

    All it does in my case is make it really difficult to have a couple friends over in my garage to smoke a joint and watch some lasers without some government entity knocking down my door (and I’m in a legal state so it ain’t for the weed).
    In truth, if you want to run a laser projector in your garage while you and your buddies smoke - just build a laser projector and run it. No one will mess with you, and you'll have a lot of fun. Be safe though - don't crown-scan. But honestly the chance of anyone saying anything about what you do in the privacy of your own home is essentially zero.

    Hell, as it is the CDRH doesn't have enough inspectors to keep up with the huge volume of legitimate, commercial laser shows. They don't have the manpower to even think about knocking your door down. You aren't on their radar and never will be. (Nor should you be, in my opinion.)

    Adam

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    Ah okay. Thanks for laying it out for me Adam! I find the challenge of exacting specifications in safety and otherwise fun to do. But yeah, just literally for home shows.

  9. #19
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    I do need to be the devil here for a second, in the spirit of hoping to find clarity since we all do it - and there is a whole subsection of this forum for "BuySellTrade". Hank commented that he has three projectors - two bought from buffo and 1 modified and built by Jason. And yet, buffo just stated, "Note, I don't sell my gear to others." (which I know means the units you've varianced for your own commercial shows) I don't suppose there is any official view on the home hobbyist recouping some of their investment with another home hobbyist when upgrading or, cleaning off a shelf or, getting out of the hobby altogether. It certainly shouldn't fall under the CDRH's umbrella but, by definition, maybe it legally does. We're ALL pretty much guilty of that at some point or another. Even if I trade someone a home constructed laser projector in exchange for cutting my lawn for the summer - couldn't that be deemed as a form of commerce?
    Last edited by Bradfo69; 11-30-2017 at 08:02.
    PM Sent...

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    Good questions, Brad!

    But Buffo never represented to me the two projectors I bought were varianced, and knowing Adam, he likely explicitly told me they weren't (not that I remember that).

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