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Comments submitted on FDA’s June 2013 proposal to regulate children’s laser toy products


(Note: this page provides some additional supporting evidence and discussion for the page “Are laser toys an actual hazard?”)

On June 24 2013, the Food and Drug Administration filed notice in the Federal Register to amend the performance standard for laser products. Among the proposed changes was establishment of a new type of laser product. The FDA’s proposed language was as follows:

  • ‘‘Children’s toy laser product’’ means a product that is manufactured, designed, intended or promoted for use by children under 14 years of age.

  • Children’s toy laser products. Each children’s toy laser product must comply with all of the applicable requirements of § 1040.10 for a Class 1 laser product and must not permit human access to laser radiation in excess of the accessible emission limits of Class 1 under any conditions of operation, maintenance, service, or failure. If a children’s toy laser product also meets the definition of a demonstration laser product or surveying, leveling, and alignment laser product, then the classification limit for children’s toy laser product applies.

The editor of this website, writing as a private citizen, submitted comments on the proposal. The comments are below. They have been slightly edited to correct typos or grammar in the original.



This comment is being submitted on behalf of myself as a private citizen, and not as part of any group or organization. I have the following concerns:

1) Whether FDA has legal authority to create a new specific purpose laser product, "Children's toy laser products"

2) Whether FDA has justification on the basis of demonstrated harm, to create "Children's toy laser products"

3) Whether FDA has justification on the basis of harm under the worst possible operating conditions (e.g., a laser beam easily turned on by children)

4) Whether the proposed definition is even correct since it uses the restrictive term "toy" but then goes on to define the product to be ANYTHING (toy, pointer, game, educational product) containing a laser and manufactured, designed, intended or promoted for use by children under 14 years of age.

5) Whether FDA will attempt to introduce any other criteria into the definition of "Children's toy laser product"; specifically, such as if the device is a laser pointer, intended for general retail store display, which could be purchased by children under 14.

6) Whether FDA intends to use this to ban or restrict "lasers intended for entertainment that create optical effects in an open room."

7) Whether this will ban CD and DVD players which are designed and marketed for children.

8) Whether other Federal agencies such as CPSC have sufficient power and jurisdiction if there are found to be truly hazardous toys designed or promoted for children.


Below are details about these concerns.

1) FDA LEGAL AUTHORITY OVER CHILDREN'S TOY LASER PRODUCTS

FDA's authority over specific purpose laser products comes from the Radiation Control for Health and Safety Act of 1968 and the Medical Device Regulation Act (Amendments) of 1976. FDA currently asserts authority over three specific purpose laser products: medical, demonstration, and "surveying, leveling and alignment" or SLA lasers.

I would like FDA to state whether these Acts, or any other, give it authority to define a new specific purpose laser product, beyond the current three of medical, demonstration and SLA.

-- If this is not the case, then FDA should withdraw the proposed "Children's toy laser product" category.

-- If this is the case, then FDA should consider additional categories which have a much greater need for definition and regulation such as laser pointers (not currently defined in any Federal statute) and handheld Class IIIb and IV lasers.

As discussed below, it may be that between FDA and the Consumer Product Safety Commission, there is sufficient existing governmental authority to remove hazardous toys, or toys with over-powered lasers, from being sold. The FDA needs to assert why its additional authority is necessary.

2A) NO DEMONSTRATED HARM TO CHILDREN

The FDA's proposal did not provide any justification for regulating children's laser toys separately from its current regulatory authority.

FDA's proposal did provide some data on laser eye injuries such as: over 100 reports from 1965-2000, 15 injuries per year from industrial and military operations, etc. But there is no data given on injuries to children, the laser powers involved, the mode of injury (self-inflicted vs. accidental), the type of laser (toy, general-purpose laser pointer, other), etc.

Further, I understand that the FDA believes that there are no data collection and analysis systems that are sources of verifiable data on laser injuries, so in their view debate regarding injuries is flawed from the beginning. However, there are some useful data collection and analysis about toy-related injuries, as described below.

In addition, it is perfectly valid to point out that if there are no reported injuries -- whether in the press, in police reports, in hospital statistics, via lawsuits, or in medical journals -- that this is a strong indication that government corrective action may not be justified.

A very important point is that it is not the responsibility of the public to prove to FDA beyond reasonable doubt that there are no laser injuries due to children's toys. Instead, the burden of proof is on the government to show why it needs to regulate what appears to be a non-problem.

Let me now turn to the indications that there is no demonstrated harm to children.

  1. As a person who seeks and compiles online reports of consumer laser misuse and injuries, I am not aware of any Internet stories, accounts, statistics, etc. of a child being injured by a laser-containing toy. I have found two news stories raising concern about toys that emit laser beams. One story was from Israel and one was from the U.K. In both cases, no actual incident or accident was asserted and there were no specifics about the laser power or other potentially hazardous parameters.
  2. With regard to youths being injured by lasers, a review of news media and medical journal laser injury stories does not show any caused by toys. (There are a very few reports of injuries caused by laser pointers deliberately aimed into a person's eyes, either self-inflicted or by classmates/"friends". Again, these are not caused by toys that contain lasers.)
  3. The Consumer Product Safety Commission operates the National Electronic Injury Surveillance System. Every emergency visit to about 100 hospitals is collected and analyzed. For a decade, from 2003 through 2012, the NEISS database contains 3,757,405 reported emergency visits. Of these, there were 52,827 reported emergency visits by 0-14 year olds, due to injury by toys (code 1300 through 1399). Of the 52,827 "toy" emergency visits, none were due to laser-containing toys. (Specifically, only three reports included the word "laser," none were due to a laser light or a toy containing a laser. See CPSC cases 120909074, 80338509 and 70326050.)
  4. As a point of reference, from 2003 through 2012, there are seven NEISS reports of persons aged 0-14 who had laser pointer beams aimed in their eyes (self-inflicted or from others) and went to the emergency room for treatment. Two of these cases seemed to have serious or permanent eye effects. Note that these were NOT caused by "toys" but by standard laser pointers.

To conclude this section, the FDA has not demonstrated any harm or need for U.S. government action to regulate lasers sold in toys or as toys. A decade of U.S. government records of over 3.5 million emergency room visits shows there were 52,827 visits due to toy-related injuries to children 0-14, of which none -- zero -- were due to lasers in a toy.

2B) CDs HARM EYES MORE THAN LASER CONTAINING TOYS

A CD or DVD player contains a laser which is used to read the disc. I searched CPSC NEISS data for 2012, to see if there were any reports of laser emission from a broken CD or DVD player. I found none.

Interestingly, however, I found that in 2012 alone, there were 53 reports of injuries by CD or DVD discs, cases or players. There were no reports of laser emission. But in just this one year, eight of the CD/DVD injury reports were of injuries to the eye caused by the discs or players. Here are three examples: an eye abrasion in a 10-year-old boy who struck himself with a CD case, a 3-year-old girl who hit herself in the eye with a CD, and a 10-year-old boy who accidentally scratched a DVD across his eye and received a corneal abrasion.

Time did not permit a more thorough search of other years.

However, it is clear just from the 2012 data that CD or DVD discs, cases or players are a proven eye hazard to children (and adults). It is astounding that the Federal Government would not take steps against a proven eye hazard like this, while proposing to regulate or ban a product which has never been demonstrated to cause harm, or even potential harm.

2C) LITTLE POTENTIAL HARM

FDA may try to justify their actions on the basis that common sense would say that children should not have toys containing lasers. However, there are existing children's products containing lasers which appear to be safe.

One example of a safe laser game is the toy "Khet The Laser Game" from Innovention Toys LLC. It uses chess-like pieces with mirrors and beam splitters that can direct (or block) a laser beam. The goal is to place them on a board so as to get the beam to a designated target. This was one of five finalists for Toy of the Year 2007 and is a Mensa Select Award winner. It is currently marketed for ages 9 and up. I do not know if the laser supplied with the game already meets the FDA's proposed Class 1 limit for children's toy laser products. If it does, great. But if not, FDA has shown no harm -- no reports of injuries or complaints -- from this game. And as indicated above, there have been no reports of emergency visits due to this game since its introduction in 2005.

Another example of safe children's products containing lasers is CD and DVD players specifically designed and/or marketed for children. As one of many examples, Disney produces a "Toy Story" CD boom box that looks like Buzz Lightyear's jetpack. Walmart sells it as being for ages 3-11. Like all CD and DVD players, the laser diode inside has a power above Class 1. This would be illegal under the proposed FDA restrictions. Here is why: The proposed regulation states that the product "must comply with all of the applicable requirements of § 1040.10 for a Class 1 laser product and must not permit human access to laser radiation in excess of the accessible emission limits of Class 1 under any conditions of operation, maintenance, service, or failure." These four conditions cover everything that can happen to a device. For example, there can be human access to the laser if it is opened (for maintenance or service) and a safety circuit fails. Because the servicing requires the product to be running (e.g., to test or troubleshoot the product), then there will be laser emission. If a switch or cover fails, then there will be human access. This requirement in essence will require that any children's toy laser product not use a laser above Class 1 inside of it.

To conclude this section, there are toys containing lasers which are safe, by all practical definitions of the word.

3) LASER POINTERS CONSIDERED AS WORST-CASE TOYS

Here is a thought experiment. What would be the most unsafe toy possible that emits a laser beam? I contend it would be a laser pointer (e.g., Class 2 or 3R handheld laser with a momentary switch).

That's because It does nothing else other than emitting a laser beam. Further, it is easy to operate: aim at something (or someone) and press a button. There is no other movement (such as a spinning top or a waving sword) that might further reduce the exposure probability or duration.

So what are the statistics for laser pointer injuries to children? Have these been shown to have a special or significant harm to children which justifies making a new regulatory category?

There have been very few reports of laser pointer injury to children. According to CPSC's NEISS data, in the 13 years 2000-2013, there have been 24 reports of emergency room visits due to lasers causing eye complaints or injuries out of 4,812,667 total visits reported. Of these, nine events occurred to children 14 or under -- children are 37.5 percent of all NEISS laser eye reports. Clearly, if 62.5% of reports are from adults, this indicates that children are not at a greater risk from lasers than adults are.

It is also important to look at each of the nine NEISS reports. There is a vast difference between coming into an emergency room for eye irritation versus having permanent blind spots. While NEISS reports do not give full details, it appears there are only two laser pointer cases involving children 14 and under where there may be temporary or permanent blurry vision or spots in the affected area.

So even for laser pointers, which are legal and currently available to persons of any age, the number and severity of incidents to children appears to be very low. Extrapolating from this, if laser pointers were allowed to be used by children (which they are under current law), there would be very little risk.

4) THE WORD "TOY" SHOULD NOT BE USED

Note: In this section, I am not considering FDA's August 7 2013 "Draft Guidance for Industry and FDA Staff" proposal. This is for two reasons: 1) The draft guidance is just that -- guidance. The real, legally-enforceable regulation is in the June 24 2013 proposed change to create 21 CFR 1040.10(b)(2). 2) I will be submitting separate comments on the draft guidance proposal.

In the introductory sections of its June 24 proposal, FDA gives two definitions for "children's toy" (numbers added for clarity):

  • "In general, FDA's criterion for a children's toy laser product is (1) a laser product when the expected use is by children under 14 years of age and (2) the laser emission has a novelty or visual entertainment purpose."

However, the actual text of the proposed new definition (in 1040.10(b)(2)) only defines the first part -- expected use by children under 14. The definition does not use the words "novelty or visual entertainment purpose"; therefore FDA should not be asserting this in the introduction to its proposal.

The actual text of the proposal uses the following language:

  • "'Children's toy laser product' means a product that is manufactured, designed, intended or promoted for use by children under 14 years of age."

This is problematic because there is no correlation between the use of the word "toy" and the actual definition. The actual definition includes any laser product (whether a toy, pointer, general-purpose laser, etc.) manufactured, designed, intended or promoted for use by children under 14 years of age. Even if the use is, for example, as a demonstration in elementary or junior high science classes, any laser over Class I would be prohibited. Thus, the word "toy" should not be used in the proposed 1040.10(b)(2). It should simply be "Children's laser product" as per the definition.

5) WILL FDA ATTEMPT TO REGULATE LASER POINTERS WHICH CAN BE PURCHASED BY CHILDREN UNDER 14?

With the broad language in the proposed 21 CFR 1040.10(b)(2), there is the possibility of the FDA proposing to regulate a class of products, such as laser pointers, if children under 14 could use them. I trust this is not the intent. Instead, FDA should be restricting only those products which have special manufacturing, design, intent or promotion towards children under 14. A statement such as "Not for use by children under 14" should be sufficient protection for manufacturers and sellers of general-purpose lasers including laser pointers.

This last point restates a previous section but it is important: The FDA's new assertion of regulatory authority over lasers made or sold to children under 14 should not affect general-purpose lasers and those commonly called "laser pointers" (handheld Class II/2 and IIIa/3R lasers), unless the laser product is specifically designed or marketed towards children under 14.

I should also restate that, while FDA's August 7 proposal "Draft Guidance for Industry and FDA Staff" does not include general-purpose laser pointers, this is a guidance document only and the final arbiter is the proposed language of 1040.10(b)(2) which is very general. So I am concerned that 1040.10(b)(2) not be intended to apply to general-purpose laser pointers.

6) WILL FDA ATTEMPT TO REGULATE ENTERTAINMENT LASERS?

In FDA's August 7 draft guidance, they give the following example of "children's toy laser products": "Lasers intended for entertainment that create optical effects in an open room."

This alone should not make a device a "children's toy laser product". If the device is marketed to children, or has specific features such as the lasers coming out of a cartoon character's head, or if it projects animated cartoons intended for children, then yes -- this should fall under the FDA's definition. But simply having a laser device that creates optical effects in an open room would not make it a "toy".

Many adults buy laser projectors which create patterns in a room; this includes Blisslights and devices sold at stores such as Spencer Gifts. As long as these laser projectors meet FDA standards and are not marketed to children, they should continue to be allowed for sale.

7) DOES THIS INCLUDE ANY PRODUCT WITH AN EMBEDDED LASER INTENDED FOR CHILDREN?

As previously discussed, FDA has proposed that the laser inside the device must not exceed Class 1 under any mode of operation, including "failure." I contend that this means "all modes of operation" since "failure" is not further defined. For example, the device could be disassembled or broken, leading to a higher emission. Therefore, including the word "failure" -- which does not appear in any other CDRH definition regarding laser products -- results in the requirement that the internal laser cannot exceed Class 1.

This further implies that a CD or DVD player intended for children would not meet the FDA's definition, since it contains a laser above Class 1 (to read the disc) and it is conceivable that there could be exposure to this under service or failure conditions.

In conclusion, the proposed 1040.10(b)(2) would ban CD and DVD players from being designed or sold to children under 14. FDA should either fix this, by better defining "failure" (or just eliminating it as with the other specific-purpose laser products), or should clarify in its draft guidance document that CD/DVD players for children would be banned so that this is clear.

8) WHAT IF SOMEONE MARKETS A DANGEROUS LASER-CONTAINING TOY?

What if a children's toy were to emit Class 3B or 4 laser radiation? This would be in violation of current FDA regulations and enforcement. If such as device were somehow to be imported or marketed in violation of current law, the FDA can use its existing powers to issue safety notices, recalls, etc. to take such a product off the market. There is no need for new regulations as in FDA's June 24 proposal.

If there are other, non-laser hazards, the Consumer Product Safety Commission would have jurisdiction. As FDA themselves note in the proposal, "The Consumer Product Safety Commission has requirements that address other safety concerns pertaining to children's toys (see 16 CFR part 1500)."

So, between the current powers of the FDA and the CPSC, there is sufficient regulatory authority over any hazardous children's toys.

CONCLUSION

In conclusion, FDA does not have the authority to define a new specific purpose laser product, FDA has not demonstrated any present or anticipated future harm due to children's toy laser products, CD and DVD players cause more harm to eyes than either laser pointers or laser-containing toys, and FDA already has jurisdiction if Class 3B or 4 lasers are used improperly. If the laser in a children's product is Class II or 3R (under 5 mW), then its output is the same as laser pointers and as has been shown, there are very few incidents of children being harmed by pointers (two potentially serious cases out of 4.8 million injury reports collected over 13 years).

For all these reasons, FDA does not have authority or demonstrated need for the "children's toy laser product" part of their proposed changes to 21 CFR 1040.10 and 1040.11