CPSIA - Comment Letter on "Children's Product" Definition

I apologize, the letter's long. . . .

June 20, 2010

Todd A. Stevenson
Director, Office of the Secretary
Room 502
U.S. Consumer Product Safety Commission
4330 East West Highway
Bethesda, Maryland 20814

Agency: Consumer Product Safety Commission (CPSC)
Re: Docket No. CPSC–2010-0029 Interpretation of “Children’s Product”

Dear Mr. Stevenson:

I am hereby submitting comments in response to the Solicitation of Comments on the Interpretation of “Children’s Product” (Docket No. CPSC–2010–0029) published in the Federal Register on April 20, 2010 (the “Rule”).

In her statement supporting the proposed interpretive rule defining a “Children’s Product” dated March 31, 2010, CPSC Chairman Inez Tenenbaum noted that the issuance of the Rule is not required by the Consumer Product Safety Improvement Act (CPSIA) but was being issued by the CPSC in response to the demonstrated need of stakeholders. I am such a stakeholder. Our company is in the educational materials and educational toy business and is regulated by the CPSIA. Ms. Tenenbaum notes that the regulated community wants predictability and certainty in the rules that govern the marketplace. She notes that the Commission “listens to, hears, and greatly values the input of the regulated community and all stakeholders”.

Ms. Tenenbaum’s statement informs my comments on the Rule. I believe the Rule does not achieve the objectives set out in her statement and must therefore be amended significantly.

Having read other comment letters on the definition of “Children’s Product”, I feel that the legal and technical details of the proposed interpretative rule will be adequately addressed by other stakeholders without my further input. I believe that this interpretative rule extends the reach of the CPSIA to many new products not covered or intended to be covered by the law, and furthermore, changes the “Children’s Product” test from one defined by “primarily” to something more mathematical (as in a 51/49 test). However, I will rely on the other letters to make the case on these points.

In this letter, I will focus on the impact of the Rule on the marketplace. In particular, I will focus on whether the Rule is consistent with the mission of the agency, is fundamentally sound as policy, meets Ms. Tenenbaum’s objective of clarity, certainty and predictability. I conclude that the Rule needs sharp revision.

The Definition of “Children’s Product” is Inconsistent with the Mission of the Agency: I think it is important to think about the Rule in the context of the goals of the agency as set forth in its enabling legislation, the Consumer Product Safety Act (CPSA). Notably, Section 2(b) of the CPSA states:

“(b) The purposes of this Act are – (1) to protect the public against unreasonable risks of injury associated with consumer products; (2) to assist consumers in evaluating the comparative safety of consumer products; (3) to develop uniform safety standards for consumer products and to minimize conflicting State and local regulations; and (4) to promote research and investigation into the causes and prevention of product-related deaths, illnesses, and injuries.”

The definition of “Children’s Product” has been incorporated into this legislative scheme designed to “protect the public against unreasonable risks of injury associated with consumer products”. Of course, “Children’s Products” is now a defined term in the CPSA and interpretation of that term, broadly or narrowly, will affect the scope of the law. Under the terms of the CPSIA, the definition of “Children’s Product” draws products into the coverage of the CPSIA, most notably in the regulation of lead-in-substrate and triggers the imposition of many other significant obligations (such as tracking labels). Nothing in the CPSIA overrides the purposes of the CPSC as set forth in the CPSA. Thus, the definition of “Children’s Product” must be evaluated in light of the agency’s mission to protect against unreasonable risk of injury.

How risky are children’s products for their lead content? The data in the CPSC’s historical recall database best describes the risk, in my opinion. These recalls reflect the evolving view of the agency on the threat posed by lead in its various manifestations in children’s products, and reflects the dangers posed by lead via the reported injuries. I analyzed the recalls posted on the CPSC website over the past 11 years and this data indicates that, over a period of approximately 11 years (from March 5, 1999 to April 15, 2010), the CPSC issued a total of 899 recalls of children’s products for all hazards (including lead and lead-in-paint). In this period, 247 recalls were associated with lead and resulted in one death, the well-known death of a four-year-old in Minnesota who swallowed a jewelry charm. [The data can be found at http://bit.ly/aOK4iS] These 247 recalls were also associated with three reported but unverified injuries from lead. Thus – over 11 years - the reported injuries from lead are four – one death and three unverified injuries.

Contrast this with the injuries associated with swimming pools and spas, a well-known source of childhood injuries. According to the CPSC’s press release dated May 24, pool and spa-related drowning deaths have averaged 385 per year for children under 15 (including 299 per year for children under five years of age) and serious injuries requiring emergency room treatments have averaged 4,200 per year. Consider this data in light of lead: lead produced one death and three unverified injuries in 11 years while pools and spas produced more than one death and 11.5 serious injuries PER DAY in recent years. Pools and spas produce more deaths and far more injuries on the average day than lead produced in the last 11 years IN TOTAL according to the CPSC’s own statistics.

The CPSC’s 2010 response to the daily deaths and maimings of children in pools and spas was a short public relations blitz. The CPSIA has imposed annual expenses in the billions of dollars on the children’s product industry to reduce deaths and injuries from lead.

If massive numbers of pool deaths and injuries merit only a public awareness campaign by the CPSC, the definition of “Children’s Products” should be downsized appropriately to reflect the relative nature of the “threat” posed by lead. The agency’s recall data on lead injuries has never been challenged by any advocate. Evidence that lead-in-substrate meets the “unreasonable risk of injury” standard set forth in Section 2(b) of the CPSA has never been disclosed. It is well-known that the CDC and the EPA link evidence of lead poisoning to only two environmental causes – leaded house paint (the primary cause) and the residual effects of pollution from leaded gasoline (generally found in dirt near inner city housing) and from industrial pollution.

The health impact of lead-in-substrate in ATVs, bikes, pens, clothing, apparel, even toys, is entirely absent from the literature as is any empirical evidence that these items could even theoretically cause lead poisoning. The advocates against lead cite studies that lead can be dangerous in small amounts and highlight the assertion that lead harms “silently”. In other words, advocates claim that because harm can befall children from lead undetected, it follows, ergo, that this kind of harm might also caused by children’s products containing trace amounts of lead. This notion is best summed up by the slogan “there is no safe level for lead”. Yet lead poisoning has never been positively identified from ANY children’s product beyond the one death and three unverified lead-in-paint injuries reported in the CPSC’s recall data over the past 11 years.

This absence of data of detectable lead-in-substrate poisoning means that the definition of “Children’s Product” in the Rule must be narrow. The mission of the agency under the CPSA does not permit it to divert resources for anything less than an “unreasonable risk of injury”. The Rule specifies a definition that is too broad for the documented minimal risk of injury from lead-in-substrate.

The Definition of “Children’s Product” Knowingly Permits Children to Remain in Danger: The Rule permits children to remain in “danger” of lead poisoning through its technical interpretation of the CPSIA. If lead-in-substrate is a public health issue suitable for the agency’s attention, this is unacceptable. The CPSC must adopt a clear rule that logically draws the line between regulated and unregulated commerce.

Let me explain:

The Rule attempts to distinguish items of “general use” and items that are primarily intended for children. The Rule notes that items of general use are not included in the definition of “Children’s Product”. An item of general use may in fact be used by children but because it is intended for a general audience, it is outside regulation by the CPSIA. This is an interpretation of the CPSIA under the Rule. The contrast in the treatment of items of general use and Children’s Products under the Rule is quite dramatic: obligations for safety testing, tracking labels, reporting, whistleblower risk, liability risk are all lifted for general use items. Children’s Products suffer the full brunt of the extensive new safety rules, presumably because of an asserted higher “risk” of injury to children.

An irony of the Rule is its acceptance of not regulating “items of general use” even if they are known to be widely or even universally used by children. The illogical and worrisome disparity in treatment of these items is best illustrated by pens. According to the Rule, pens are typically items of general use and are therefore (as a general rule) NOT regulated by the CPSIA. This result is quite helpful to the agency, as the pen industry has purportedly informed the CPSC that ball points must be made with brass, and brass has minimal lead content as a basic ingredient. No one argues that brass ball points have ever exposed anyone to injury from lead poisoning, not do “human factor” experts contend that contact with ball points are likely to present a risk of lead poisoning. Thus, the inclusion of pens in the broad reach of the CPSIA has been called an “unintended consequence”. So the “right” answer for all concerned is that pens shouldn’t be included in the CPSIA. The CPSC has consistently held that pens are outside the definition of “Children’s Products”.

Notably, it is well-known that close to 100% of school-age children routinely use ball point pens. Children carry pens in their backpacks and use them every day in school. Pens are a particularly ironic choice for this rulemaking example because pens are known to be routinely mouthed (chewed) by all ages of consumers including adults. However, use of pens by kids is deemed “unregulated” under the CPSIA and the Rule because pens have been held to be items of general use. Strangely, pens are in fact subject to regulation under the CPSIA if “decorated or embellished by adding certain features that may appeal to children, such as childish themes or play value”. The Rule holds that if the embellishments are “likely” to attract a child’s interaction with a pen, then it would be considered a “Children’s Product”. So the operation of the Rule is that a pen is subject to regulation if it has an embellishment but not subject o regulation if it omits the embellishment. The CPSC does not indicate that the embellishment itself is a public health or safety concern nor argues that the presence of the embellishment will raise the likelihood of use of a pen by children. The CPSC concedes that children are widely using pens now.

This flaw in the Rule will subject the CPSC and its rules to ridicule. There is no justification for the agency’s safety regulations applying only to some pens, not based on evidence of risk but because of a hyper-technical interpretation of the definition of “Children’s Product” under the CPSIA. The Rule simply makes no sense as public health policy. If the presence of lead in ball points is an actual health risk (which it is not), then there is no excuse to omit any pens from supervisory regulation. If the presence of lead in ball points is NOT an actual risk to health, then there is no excuse to regulate ANY pens under this law. Writing an interpretative rule that can’t seem to make up its mind is, frankly, worse than no rule at all.

The Definition of “Children’s Product” Does Little to Add Clarity for Regulated Companies: The convoluted definition of “Children’s Product” set forth in the Rule fails to bring clarity to the broad reach and operation of the CPSIA. Regulated companies will never be able to consistently apply the Rule in the real world, and worse still, will never be able to find peace (agreement) with their retailers (dealers) on the application of the Rule. Chaos is certain to ensue. This problem is again best illustrated by pens. Pens are items of general use and thus deemed to be unregulated under the CPSIA. The Rule notes an important exception, however: “when a general use, such as a pen, is decorated or embellished by adding certain features that may appeal to children, such as childish themes or play value, the general ruse product may be converted or transformed into a children’s product due to these additional features of characteristics.” [Emphasis added]

The Rule goes on to note that there is an exception to the exception: “However, there also are ‘novelty’ pens that could appeal to children 12 years of age or younger as well as older children and adults; such novelty pens would not be considered to be primarily intended for children. For example, a simple ball point stick pen bearing an elementary school’s name, without any other decorations, would likely appeal to anyone (i.e., students, teachers, parents) connected with the school. A pen with a silly head on the top, not associated with any particular mass media (and not sold in toy stores) may have just as much appeal to adults as it would to children. Pens with puzzle features that allow the user to take them apart and reconfigure the design also are likely to appeal to children and adults alike, and thus, are not likely to be considered children’s products because they are not primarily intended for children.” [Emphasis added]

The fact that children were already “interacting” with pens in the absence of the “childish” embellishments seems to be irrelevant under the Rule, raising the issue of how to tell when a product’s use by children is deserving of safety testing or the application of tracking labels. These are “big dollar” questions for the regulated community. If an embellishment is “appealing” to children, then if children “interact” with the pen based on foreseeable use and misuse of the product, it is apparently considered a children’s product . . . unless the embellishment has “just as much appeal” to adults or children, in which case it is a product of general use. And if the pen is unadorned but used by every child due to a marketing scheme directly aimed at the kids market, no testing or labeling is required (see discussion of musical instruments below).

It seems so obvious . . . .

The clear holding of this “policy” is that stick pens used by every child every day in every classroom do NOT require testing. Were you to remove those ordinary pens from the classroom and apply a “childish” embellishment with inks or paint supplied by the CPSC (stipulated to be entirely lead-free) and then return them to the children, the pens would now need to be tested and labeled. This, of course, makes absolutely no sense, and gives the necessary impression that the CPSC is more concerned with technical compliance issues (test reports without meaning or significance) than with notions of safety. How are regulated companies supposed to follow such incomprehensible or nonsensical rules? There is no answer to this question. Retailers (dealers) take a different tack when confronted by nonsensical rules – they crawl into a shell and invent their own “safety rules” designed to create a cushion between their practices and whatever 20-20 hindsight analyses could be used by regulators. This creates a Wild West of safety rules and practices for manufacturers: chaotic, unpredictable, penal and extremely expensive.

The Rule seems to delight in this convoluted reasoning. Consider the Rule’s stance on the marketing of musical instruments to schools: “Products with a marketing strategy that targets schools, such as instrument rentals, would not convert such products into children’s products if such products are intended for general use, regardless of how the instruments are leased, rented or sold. These instruments are intended by the manufacturer for use primarily by adults, although there also may be incidental use by children through such programs.” Incidental use? In many schools, the “incidental use” induced by these targeted programs is nearly 100% of the kids. It is difficult to take the CPSC seriously about its “passion” for eliminating lead in all manifestations when it enacts a rule that openly permits unregulated use of brass musical instruments by school kids while banning brass in toy wheel assemblies or requiring testing for certain pens because of the brass content in their ball points. This policy is best described as “two-faced”.

Let’s not forget that this Rule is hardly restricted to pens. Paper clips are known to be in wide use throughout society and also by children in the regulated age ranges. As products of “general use”, paper clips are specifically cited in the Rule as exempt from testing and the other requirements of the CPSIA. That makes sense – despite the uncontested fact that paper clips are routinely chewed on by adults AND children. I assume that the lead content in paper clips would have an equal (or greater) ability to erase IQ points as lead in children’s products that also might be mouthed – but let’s not worry about that now. The Rule sensibly draws the line at paper clips for the foregoing reasons, and whatever “hazard” chewing or sucking on paper clips may present has been overlooked as a public health risk. Unfortunately for our education business, it’s not that simple: “Manufacturers may also include a general use item as one of several items packaged together, such as a paper clip included in a magnet set primarily intended for children ages 7 through 10 years old. The paper clip may be a general use item but when included as part of the magnet set, it would need to be tested to the applicable children’s product safety rules since the product is targeted primarily to children 12 years of age or younger.”

What is achieved by this rule? High expense, much confusion, many arguments with retailers and sharply-reduced respect for the CPSC’s rules.

Please note that the Rule leaves all elements of these subjective judgments open to doubt. Consider pens again – because the Rule encourages us to reason from the pen example. The CPSC took no definite position on anything applying to pens other than that an undecorated stick pen is outside the CPSIA. Anything with an “embellishment” presumably will be the subject of endless debate in the regulated community under the Rule. If you guess wrong on the application of the Rule, the law provides (and CPSC practice now reinforces) tremendous liability risk. Let’s not forget that we in regulated community know about the $2.05 million penalty assessed against Daiso for five recalls of less than 700 units in total. Liability risk under the CPSIA seems virtually unlimited nowadays. Subjective interpretative rules applied with 20-20 hindsight by regulators would likely expose manufacturer to the highest risk at the worst possible time, namely when there’s a real problem. How can manufacturers defend themselves? The wishy-washy design of the Rule provides nothing for a manufacturer to rely upon.

The Rule makes same similar confusing distinction on DVDs and CDs and seems to imply that many promotional products will be subject to doubt under this Rule. Almost anything useful that has a so-called “childish” embellishment might be regulated now, possibly without the manufacturer even knowing! The Rule states that manufacturers “should expect” that adults will give their embellished or “childish” products to children even if made specifically for adults (the example cited is a stuffed animal sold with a candle). The fact that some businesses target adults with such items (intent!), or the fact that the Rule contemplates that adults are often drawn to the same items as children, seems to be forgotten here. At a minimum, the Rule seems entirely subjective. This not being confusing enough, the Rule notes that if the items that children are drawn to happen to be considered “collectibles”, then perhaps they won’t be considered children’s products. Or maybe they will.

To put a bow on the confusion, the Rule concludes that classic games like checkers or Chinese checkers (among other common games) are NOT children’s products. I simply cannot imagine a toy company DARING to leave these classic games untested yet the CPSC has now officially ruled that certain classic games are exempt from the CPSIA. However, if the manufacturer is foolish enough to promote these games with images “or other features . . . that make [the games] more attractive to or suitable for children than a general use product would normally be”, well then they are magically transformed into children’s products.

I literally do not know how to apply a rule so full of convoluted logic and word games. Likewise, I cannot envision smoothly functioning markets governed by a rule like this.

Notably, the weight placed on advertising portrayals with children will only intensify arguments between manufacturers and their customers about what is and what is not a children’s product. For instance, we sell magnifiers and tape measures that are identical to those sold at Home Depot. By any definition (and as acknowledged in the Rule), these items are items of general use. We happen to photograph them with children for our catalog and website to illustrate the products’ utility in educational settings. How are we supposed to determine definitively that these items are not children’s products under the law, much less get our customers to agree with us? To date, no customer has agreed with this conclusion. NOT ONE.

The Rule posits a bizarrely unrealistic deliberative process in which each photograph is “weighed” against each other to determine its “true nature”, as though that were possible: “The prominence, conspicuousness, and/or other emphasis given to each portrayal of a product’s use or intended users on packaging or in advertising media can be weighted differently according to which images or messages are the strongest and most obvious to the consumer at the point of purchase.” This language makes me want to scream. To avoid business risks under this rule, businesses may have to produce catalogs and websites that look like this: http://bit.ly/d4vtZo.

The Rule confounds by assigning responsibility to the manufacturer for its retailers’ independent choices on where they place items in their stores or in their various catalogs, web pages and ads. Of course, each retailer will make this choice differently, possibly store-by-store, catalog-by-catalog, ad-by-ad, web page-by-web page, region-by-region, country-by-country and so on. In reality, this standard is even vaguer than that, as the judgment is whether the images “could imply [the product’s] suitability for a certain age group”. [Emphasis added] In any event, we manufacturers have neither control over, nor knowledge of, these choices by third parties.

All this makes me wonder why the Rule doesn’t simply state that the CPSC will decide after the fact what is and is not a “Children’s Product” based on its subjective personal opinion at the time? That rule formulation would at least be honest and clear.

I believe the agency has given scant thought to the reality of living with this rule. How does the CPSC envision that a manufacturer and a retailer would resolve a dispute over whether a product is subject to regulation? Think about people who sell pens. What is the likelihood that there ever be agreement that a particular embellished pen is outside this law? I fear the effect of this vague, quirky and completely indeterminate rule will be that everyone associated with children’s products will throw up their hands and assume that everything is subject to the full brunt of the CPSIA. If that’s the intent, I wish the CPSC would just come out and say it.

What Should the CPSC Do? The answer to this question is clear in light of two factors: (a) in the Chairman’s statement, she indicated a strong interest in bringing certainty to this rule and further notes the importance of certainty to the marketplace, and (b) the extremely low incidence of injury and death reported from lead in the last 11 years. As noted in great detail above, there is nothing “certain” about the Rule as presently written. It includes far too many phrases like “may”, “could”, “in general”, “weighting”, “factors” and so on. The Rule as written is the antithesis of clarity and certainty.

The CPSC has as its mission “to protect the public against unreasonable risks of injury associated with consumer products”. With so few injuries and one death from lead over the course of 11 years, the perils of lead have not been demonstrated to rise to the level of an “unreasonable risk of injury”, particularly when viewed in light of the known impact of so many other dangers regulated by the CPSC (such as small parts or pool injuries).

For a rule to bring “certainty” to the market, there must be a way to make a definitive judgment, one that can be relied upon. Subjective judgments and weighing of factors may make sense for a court but has little value to regulated companies in an active marketplace. Who gets to decide which judgment is “right”? Under the present Rule, no one does.

The way to resolve this dilemma is to learn from the statistically significant history of low injuries from lead, and make a concession in favor of certainty. The right rule for the definition of “Children’s Product” is to state that the “reasonable judgment” of the manufacturer on what is and what is not a “Children’s Product” under the CPSIA will be RESPECTED by the CPSC. I believe the term “reasonable judgment” is understood in the marketplace, and is also a well-defined term in the common law. It has been clarified in countless cases, providing clear guidance to all concerned (regulators, regulated companies and consumers). The CPSC should further indicate that it will NOT review the judgments made by manufacturers in the absence of fraud, a recall situation or other serious violations of law or CSPC regulations. Retailers should be entitled to rely on the reasonable determinations of manufacturers by RULE.

My concept is that the reasonable business judgment of manufacturers will appropriately shape the range of products regulated under the CPSIA. In actual fact, the reasonable judgment of manufacturers on determinations of “Children’s Products” is tightly confined by the CPSIA, so little risk to the “will of Congress” can be anticipated. In addition, given the long track record of so few documented injuries from lead (going back for many years before the CPSIA’s enactment), there is little reason to believe this practical rule will expose children to more injuries. In any event, this will allow the agency to focus its energies on greater threats. The agency also has plenty of legislative authority to draft other rules to address lead concerns if the need arises.

A rule drafted in the vague, quirky, subjective, indefinite and convoluted manner of the Rule achieves little other than amplifying the frustration and confusion of the regulated community. Having filed numerous comments letters over the last two years, testified before Congress and the CPSC on several occasions, had personal meetings with CPSC staff, written blog posts, attended rallies, and so on, I can attest to the deep frustrations associated with implementation of the CPSIA. After all this time and effort, we manufacturers are still “in the soup”. With this Rule, the CPSC begins the final stage of the implementation of the law, and potentially, places the capstone on our ruin. This Rule, plus the so-called “15 Month Rule”, taken as a whole, has the potential to put many companies out of business. I do not know how we survive both of these rules in their present form. It’s time for the CPSC to take a reality check. If the Chairman is serious about bringing certainty to the market and to regulate without putting companies out of business, it’s time to make some concessions and let the good companies who produce children’s products run their businesses and accountably produce safe products using reasonable judgment. This strategy will work. Policies like the Rule will not.

Thank you for considering my views on this important topic.

Sincerely,

Richard Woldenberg

Chairman
Learning Resources, Inc.
380 North Fairway Drive
Vernon Hills, IL 60061