Original post:
CPSIA – What You Get For Your Database Dollars

Why did Mr. Pritchard find this outcome “stunning”? After all, in response to a question about the risks involved in the glasses, Pritchard had this to say in a TV interview: “The [lead and cadmium] levels are low in the sense of . . . no one is going to touch this glass, put their hand to their mouth and fall ill. This is a low level over time concern.” If the glasses are a low risk, why would he expect a federal regulator to waste time or resources on them?

Even more remarkably, Pritchard knows that the McDonalds Shrek glasses were found to be non-toxic by the CPSC. He broke the McDonalds story. The Shrek glasses present precisely the same “issue”. He also knows lead is only restricted in children’s products and that enamel coatings containing lead are permitted explicitly in the law (16 CFR 1303.2(b)(1)). There is no evidence that the presence of lead in the enamel has ever injured anyone. Ever.

So why is Pritchard continuing to push a story that he knows is defective? This puts it kindly. Let’s rule out that he is seeking a Pulitzer or has an ill-motive. Why would he do this?

Of course, we know there is a bias in reporting and in investigating that favors reporting “bad news”. Good news is not really considered news at all (except on the sports page). The media’s incentive is to publish terrifying stories – it sells papers and banner ads, and it’s natural for Congress to push legislation to save us from poorly understood threats as an extension of this trend. But something else is at play, it turns out.

This subject is analyzed in an interesting article by Jonah Lehrer in this week’s New Yorker magazine entitled “The Truth Wears Off”. Lehrer tries to explain why replication of scientific studies tends to show declining results over time. This is quite unexpected given that scientific studies are subject to peer reviews and are often published by periodicals with their own high standards of review. Lehrer notes that in small studies, weird results can show up (such as a 1930′s study which claimed that one Duke University student had ESP but later retesting revealed the student’s rapidly diminishing extrasensory powers . . .). In larger pools of data, results revert to a mean (this is called “funneling”). However even statistical significance doesn’t explain the phenomenon. Lehrer shows that we only get to see certain slices of data. Most data won’t be published because it’s not interesting or doesn’t confirm prejudices.

Put into a CPSIA context, Lehrer implicitly argues that media won’t write a story announcing that lead-in-enamel on your glassware is safe. Nor that you were always fine and your children weren’t in danger. Nor that there have been few injuries from lead in any children’s products. Nor that the few known injuries in the context of the large volume of products in use is actually a GOOD result. Nor that there are no identified victims of “phthalate poisoning” or that incidents of cadmium poisoning in American children are virtually unknown. The excuse – it’s not “newsworthy”. What’s the reality?

The reality is that we are exposed to a very imbalanced set of data. Quoting Michael Jennions, a biologist at the Australian National University, Lehrer argues that “the tendency of scientists and scientific journals [is] to prefer positive data over null results, which is what happens when no effect is found.” If the null set (the “everything’s fine” news) doesn’t get reported, what does? Says Richard Palmer, a biologist at the University of Alberta, “We cannot escape the troubling conclusion that some – perhaps many – cherished generalities are at best exaggerated in their biological significance and at worst a collective illusion nurtured by strong a-priori beliefs often repeated.”

The same mantra over and over? The words “Rachel Weintraub” suddenly pop into my mind.

Lehrer continues: “[T]he problem seems to be one of subtle omissions and unconscious misperceptions, as researchers struggle to make sense of their results. Stephen Jay Gould referred to this as the ‘shoehorning’ process.” Referring to studies in Asia that consistently confirm that acupuncture is effective, and studies in the West that show much poorer results, “Palmer notes, this wide discrepancy suggests that scientists find ways to confirm their preferred hypothesis, disregarding what they don’t want to see. Our beliefs are a form of blindness.”

Or to quote Robert Adler, anecdotes aren’t evidence.

John Ioannidis, an epidemiologist at Stanford University who once published a study entitled “Why Most Published Research Findings are False”, calls the phenomenon “significance chasing” where scientists play with numbers trying to find “anything that seems worthy”. In a news context, this is the same as Pritchard fingering the Super Hero glasses on the grounds that there is lead in the enamel even though he knows the Shrek glasses were safe. Maybe these other glasses are a problem?! Jeff Plungis of Bloomberg published an article on lead in Christmas light wires on December 8th because he apparently thought it was “interesting” and not well-known. Same thing.

Ioannidis says “It feels good to validate a hypothesis. It feels even better when you’ve got a financial interest in the idea or your career depends on it. And that’s why even after a claim has been systematically disproved . . .you still see some stubborn researchers citing the first few studies that show a strong effect. They really want to believe that it’s true.” [Emphasis added]

Lehrer’s article is a great read, I recommend it to you.

So you can stop scratching your head. Pritchard and Plungis, Adler and Tenenbaum, Waxman and Schakowsky, Weintraub and Green, will all continue to beat the same drum. They know they’re right . . . they just can’t prove it. And they will continue to repeat themselves in spite of the facts of this case:

• There are (virtually) no known victims.
• The impact of the law cannot be measured.
• The nexus between lead in children’s products and purported injury to children is not proven. This means that the inclusion in the law of so many formerly unregulated categories of goods is absolutely unjustified.
• The benefits of prophylactic testing has been disproved by the passage of time – the last 29 months.
• The law targets small business and lets big business off the hook. Even since passage of the CPSIA, it is clear from data that big business are responsible for headline recalls.

I guess the media keeps on publishing these stories because it’s human nature. Unfortunately, many jobs and many futures have been damaged in the service of a human weakness. I like to think we can rise about such limitations. It is in the hands of the CPSC and Congress to solve this problem.

Let’s hope they do their job . . . sometime really soon.

Read more here:
CPSIA – Why Does The Press Push Bad Ideas?

Seven days to go! Go, baby, go!

I just found this article documenting the pain of some Illinois toy craftsmen owing to the CPSIA. Imagine, these guys are being held up by the noxious CPSIA and are essentially shut down. I have been reading these articles for almost three years now. Ho-hum.

Have any of you heard of Mattel or Hasbro going out of business because of this law? Me, neither.

Articles of this type are discouraging on several levels, not least of which is the lack of comprehension of almost everyone who gives a quote. The scale of the problem for small business, even the very nature of the problem presented by the law is unclear, apparently. No one asks the right questions like – why are we doing this? What are we achieving? Is it worth the cost? Can we even measure what we have accomplished?

Of course, the answers to these questions are all negative. No one knows why we’re doing this, other than a general love of children. Don’t know about you but a “general love of children” is a rather flimsy justification for killing off an entire industry (other than mass market companies like Mattel). Given that we have many fine universities here and train the occasional engineer in this country (I am one of them), I would think we could be a just a little more “science-y” in our analysis. So, if we can put our “general love of children” on the shelf for just a moment, why indeed are we doing this? To improve the health of children, right? That sounds good to me.

To assess whether we have had any impact on the health of children, presumably we would need to be able to describe what is WRONG with the health of children now. The zealots assure us that there is no safe level of lead. They also assure us that lead harms children “silently”, in other words, the harm cannot be measured accurately, but trust us, it’s there. In other words, there is no way to differentiate between lead “poisoning” in children not presenting symptoms – and a purely imaginary condition in those same children. The “real” problem and the imaginary problem present exactly the same way – no symptoms. Contrast banning pixie dust with banning lead-in-substrate – the issues are the same.

[Ed. Note: Apparently there ARE safe levels of lead in musical instruments made of brass if they are full-sized, but not if they are under-sized. This is part of the new interpretative rule on the definition of "Children's Products". Therefore, if you had a small trumpet (dangerous, subject to regulation) and you stretched it, making it into a full-sized trumpet with thinner walls of brass, it would become safe (no regulation)! Hmmm. This is not magic, this is the CPSIA!]

And if you want to measure your impact on this dreaded problem, how would you do it? The health statistics are purely made up, because there are no symptoms. The reasoning goes – since there is “no safe level” for lead, then we must consider anything that could possibly cause a blip in blood lead levels as a causative agent, therefore, we must ban everything that COULD POSSIBLY make blood lead levels rise.

Given that blood lead levels are declining these days and are not considered a health risk by the EPA, FDA, NIH or CDC except in connection with certain specific hazards (leaded house paint, residual pollution from leaded gasoline, or other environmental factors like air pollution), we cannot measure any improvement in health. It’s literally impossible (remember, the “real” problem and the purely imaginary problem present exactly the same way). Thus, it will be impossible to measure how much we have achieved for our investment. We must cling to our assertion that there is “no safe level” for lead to assure ourselves that we have accomplished something. This is a logical argument, but there’s no evidence to support it.

So the entire exercise is speculative? The benefits cannot be measured. The problem can’t be measured or even described accurately. There weren’t any victims before, there aren’t any victims now. Seems like nothing has changed. Uh-oh.

Ah, thumb suckers, THAT isn’t true. Something fundamental has changed, thank you Congress. Safety hasn’t improved . . . but a few things have changed substantially:

1. Our regulator is no longer capable of exercising a judgment about what is and what is not safe. Consider the musical instrument example above. The CPSC has also become quite aggressive, perhaps to justify its existence and its new jumbo budget. Not pretty.
2. The cost of compliance has already skyrocketed. Those dollars are coming out of activities that would otherwise be used to grow our businesses.
3. You ain’t seen nothing yet on costs – wait for the CPSC to approve the 15 Month Rule on testing frequency and reasonable testing programs. Costs will rise by 10-100x for many companies if the rule is adopted as presently drafted. I’m not kidding.
4. Complexity and risk have skyrocketed. What do people do when they can’t figure out the rules or they get scared about the consequences of failure? They exit.

   [Here's another pre-Xmas threat by the ever-lovable Inez Tenenbaum: "'We will continue to recall their products and it will damage the brand. There will be penalties, there will be lost customers,' she said in an interview." She's quite a charmer, isn't she? Does this sound good to you? Want to enter the Children's Product market? Want all your family's wealth dependent on the health of a business in this market, being regulated by Ms. Tenenbaum? Hmmm, the line's out the door, everyone wants in!!!]

5. Products and markets are being dropped, or aren’t being entered in the first place. Profits are being lost (profit prevention) and jobs are being shredded. Lots of jobs . . . .
6. It’s not fun anymore to be in this business.

As for the Illinois wood toymakers, it’s a shame for them. We read about this kind of thing all the time. Maybe it will go away on its own. Maybe it’s all their imagination. Small businessmen are often so unsophisticated, they probably don’t know what they’re talking about. The U.S. government is just too smart to get something this wrong. If they really screwed up, they’ll fix it – the government’s not the enemy, you know. Something this big and stupid can’t be true. Somebody big and important, like a trade association, will save us. No, no, 60 Minutes or John Stossel will do an embarrassing story and that will break the logjam. [Ed. Note: been there, done that.] I’m too busy running my business to address this. You can’t fight City Hall. It will get fixed, don’t worry! Nothing this ridiculous lasts very long.

Boy, that thumb must be yummy! But at your age, thumb-sucking seems so inappropriate.

Don’t forget to vote on November 2nd. Even if this scourge won’t go away and has become entrenched, you can still strike a note for capitalism and for sanity by voting against the idiots and the venal people who want to destroy your businesses and deprive you of valuable products that you prize. You can defend yourself – and you MUST.

Read more here:
CPSIA – Let’s Keep Sucking Our Thumbs . . . .

Many people use data relating to lead and childhood injuries that play on basic human emotions. After all, who would want another child to be injured, much less killed? That truism is justification for the CPSIA as “necessity”, notwithstanding possible “unintended consequences”. Even the mere mention of cost and effectiveness discredits opponents of the law.

A convenient example of this phenomenon is Henry Waxman’s opening statement at last week’s hearing. He called out three separate incidents of injury to kids: “Just over four years ago, a little boy named Jarnell Brown died of lead poisoning when he swallowed a metal charm that came with a pair of kids’ shoes. A year later, in 2007, two children became comatose and had to be hospitalized because of a children’s toy that turned out to have a toxic drug in it. That same year, millions of cribs were recalled for a simple defect that had caused multiple infant deaths.“

These three groupings of injuries are unrelated and derive from radically different hazards. Jarnell Brown swallowed a jewelry charm made of lead. The two kids were affected by AquaDots, an unprecedented, one-of-a-kind chemical toy defect. Crib injuries are obviously of a different nature and involve a separately regulated category of child (infants) subject to unique risks. Despite the wildly disparate data, he concludes: “The bottom line was clear: our system for keeping children safe was broken.“

While I think that the Cubs are pretty mediocre and so are the Bulls, I don’t think Chicago is broken. This is apples-and-oranges. So goes the CPSIA debate.

Let me be clear, I am not saying Waxman INTENDED to mislead with his remarks – no, in fact this is how most people have treated data in support of the law. Few if anyone uses actual balanced injury or hazard data. Even the fear mongers’ standard of “there’s no safe level for lead” is almost obviously untrue but it strikes an emotional chord and is, at one level, hard to refute. Clearly, sprinkling lead on your bowl of cereal in the morning isn’t recommended. That said, it is equally clear that lead is very infrequently deadly and since we all consume lead daily by breathing, eating and drinking, it must be tolerable (at a minimum) at certain dosage levels. Thus there has to be a “safe” level for lead – or else we’d all be as dumb as a box of rocks. I consider to be a simple observation.

So what’s the truth? Data on recalls and the hazards uncovered by the CPSC is frankly hard to come by. I went through the exercise of preparing a 25-month analysis of lead-in-paint back in February 2009 and published my data. The data were great but frankly, I needed more. So I set out to prepare a much broader survey of recall data so we could really talk numbers. I have attached a data analysis of the 899 CPSC recalls of Children’s Products between March 5, 1999 and April 15, 2010. This is slightly over 11 years of data and while it is a somewhat arbitrary period, I consider it statistically significant and useful to reason from.

A few caveats: I prepared this data with the assistance of several people and spent quite a bit of time cleaning it up. It is good data, but almost certainly inaccurate in some respect or respects. This is not intentional and I would certainly welcome notice of any errors you may find. The source of the data is posted recall notices on the CPSC website. The categorization of products and hazards might be considered quirky and could be misleading if you do not look at the details. However, overall, this is the best data I know of for an analysis of injuries and deaths from Children’s Products.

The rationale behind this analysis is that official CPSC recall data over an 11-year period reflects the policies, judgment and decisions of the agency and is revealing about what the agency thought was and was not important during that period of time.

The spreadsheet has three worksheets. You have complete access to ALL of my data. I have incorporated hyperlinks to EVERY recall in the spreadsheet, so you can dig deeper if you are so inclined. The first sheet, entitled “Total by Category” is sorted by Product Category. The second sheet, entitled “Total by Year” sorts the same data by Recall Date. The final sheet, entitled “Summary by Product” includes FOUR ANALYSES pulled from the first two sheets. There is recall statistical data by (i) product category by hazard, (ii) hazard by product category, (iii) year by hazard, and (iv) hazard by year. Four slices of the data, never before seen.

Some interesting facts:

• Grand Total Recalls: 899
• Grand Total Children’s Products Recalled: 3,128
• Grand Total Units Recalled: 308,697,297 (remember, this is over 11 years)
• Grand Total Injuries to Kids from Recalled Products: 2,381
• Grand Total Deaths from Recalled Products: 35

Okay, let’s unpack this data. First of all, this is inclusive of ALL Children’s Products. That would include the recall of 150 million units of vending machine jewelry in 2004. It also includes all crib, bassinet, play pen and stroller recalls. Even common toy box recalls are included. You are welcome to react emotionally to these gross numbers, but please remember, this is a mishmash of 11 years of data at the macro level. We need to probe more deeply for real insights.

For perspective on these data, please consider CDC data on childhood mortality: the current mortality rate for kids age 1-4 is 4,631 per annum (leading causes of death: unintentional injuries and congenital malformations) and for kids age 5-14 is 6,149 per annum (leading causes of death: unintentional injuries and cancer). I believe unintentional injuries are principally car accidents. Anyhow, this implies an 11-year mortality rate of 118,580. Notably the annual mortality rates exclude kids 0-1. I don’t have those numbers and haven’t bothered to look for them. You get the picture. The CPSC has accounted for 35 deaths in the same period.

It bears noting that these statistics suggest that our markets are in fact rather safe. Injuries to children and deaths associated with Children’s Products, while unacceptably high, are just 0.03% of the overall mortality statistics. We can and should continue to focus on improvements, but we should also have some perspective on our challenge. Polishing the apple is different than crisis management.

To further clarify the injury/death problem from lead, let’s look at the breakout of injuries and deaths by hazard. Unlike my February 2009 analysis, this data shows all hazards and all recalls in the 11-year period. Please note that some of these hazards are very closely associated with one or two product categories. Lead is closely associated with jewelry. Lead-in-paint is largely associated with toys but touches almost all product categories. Falling and entrapment is a largely infant category. Strangulation is mainly clothing (certainly of late, with all the drawstring recalls) and infant products. With this data, you can see what comes from where.

Injuries and deaths from Children’s Products in this period break down as follows:

• Brake Failure 0, 0
• Burns 74, 0
• Cadmium 0, 0
• Choking 150, 3
• Collision 2, 0
• Falling/entrapment 1803, 17
• Fire hazard 4, 0
• Illness 0, 0
• Impalement 0, 0
• Laceration 284, 0
• Lead 3, 1 [The only death from lead in 11 years is Jarnell Brown, mentioned above.]
• Lead-in-paint 1, 0 [That's right, ONE INJURY in 11 years, no deaths.]
• Magnets 3, 0
• Strangulation 26, 7
• Suffocation 29, 7

A quick question: if you were running the CPSC and had access to this data, what would you focus on? Interestingly, if you look at lead and lead-in-paint recalls in the early years of this data, you will see something that seems somehow quaint now, namely very few recalls and in small quantities for lead and lead-in-paint.

• 1999: 0 recalls [partial year]
• 2000: 0 recalls
• 2001: 5 recalls
• 2002: 3 recalls
• 2003: 4 recalls
• 2004: 6 recalls
• 2005: 10 recalls
• 2006: 16 recalls
• 2007: 98 recalls
• 2008: 65 recalls
• 2009: 29 recalls
• 2010: 11 recalls [partial year]

Was the agency napping . . . or was the CPSC behaving rationally? What were they doing when they could have been catching lead-in-paint violations? Check my analysis: they were focusing on choking, falling/entrapment and laceration, presumably because these hazards were causing BY FAR the most injuries and deaths. Lead and lead-in-paint produced almost no injuries or deaths for 11 years. It is also worth noting in 2007, that under withering political and populist pressure, the agency changed its recall policy on lead and lead-in-paint to strict liability (every violation was recalled). In the early part of the decade, many lead violations were dealt with privately by the agency, making statistical comparisons impossible (and giving the incorrect impression of laxity by the agency at that time).

The data is also useful to give perspective on the effectiveness of the CPSIA’s application of regulatory and corporate resources to new safety activities. In conjunction with last week’s hearing, the HTA filed an economic analysis prepared by an independent safety consultant that projects aggregate annual CPSIA testing costs of $5.6 billion. Personally, I think that number is very low for the all-in economic impact from this law, but for the sake of argument, let’s use it as THE number for regulatory compliance. So we are all going to spend $5.6 billion ANNUALLY to comply with this law regulating lead and phthalates. Over an 11-year period, ignoring inflation, our costs will be $61.6 billion. This expenditure is presumably designed to reduce the incidents of lead poisoning and phthalates. We have accounted for four injuries and one death. That’s what our $61.6 billion is aimed at.

Consider this: if we really want to keep kids safe, we should be somewhat indifferent to HOW they are injured – we just want to protect them from harm. Thus, a bump on the head, a broken arm and lead poisoning are all the same, equally bad. So what if we spent at the same rate on ALL injuries and death identified in CPSC recalls, at the projected CPSIA spend rate? Our cost would be $61.6 billion / 5 (11-year lead and lead-in-paint injuries and deaths) X 2416 (total injuries and deaths in the same period). Sitting down? The total compliance cost we would bear over 11 years would be $29.8 trillion ($2.7 trillion per year). The current national debt is $12.95 trillion. Please also consider that our annual safety expenditures would exceed the expected receipts of the federal government this year ($2.4 trillion). If the federal government only funded us, the government would still run a $300 billion deficit this year.

Call me a worrywart, but I think that kind of safety spending is a bit over the top.

The debate over safety has dramatic economic implications. Safety is a principal concern of the industries serving children’s markets, of course, but if we are crippled economically we won’t be around to make safe products. There is a sensible balance that can be achieved. The data suggests that the CPSC actually knows what it’s doing (at least it did before it became a political football) and can properly allocate its resources.

If the CPSC were entitled to focus on real safety risks (based on data), not the phobias of politicians and consumer groups, and if they could be convinced to stop trying to run our businesses for us, I think we could reduce and refocus safety spending and become much more effective in improving safety.

Numbers don’t lie. It’s time to reassess and amend the CPSIA. And if the Dems won’t let us do that, it’s time to reassess them and Congress as a whole.

Read more here:
CPSIA – Numbers Don’t Lie

How much of a difference is this? Pretty big, to judge by the frenzy over cadmium in jewelry. Seven Senators have sponsored a bill called the Safe Kids’ Jewelry Act. This law would ban the use of cadmium in kids’ jewelry. Is this “good”? I am not sure how to answer that. To my knowledge, no one has identified a single injury from cadmium in children’s jewelry. It is undeniable that cadmium is a bad element and has the potential to harm. Ergo, jewelry with cadmium is “bad”? I can imagine circumstances where cadmium in jewelry might hurt a child. Then again, if it were so dangerous, where are all the victims?

If this is going to be the new standard, whether a product MIGHT harm someone, I think we are cooked. Assuming that “prevention of possible injury” is to be used as the standard to evaluate products or components of products, let me ask a few questions to see if I understand the “new rules of the road”:

• How certain must the prospect of injury be?
• How specific must the circumstances of the prospective injury be?
• Are we talking about probable injury (more than 50%) or possible injury (odds greater than 0%)? How are those odds to be measured – by unit sold, by contact, by owner, by year, by lifetime use? What’s “reasonable”? [Does anyone care what's reasonable?]
• Are all things that could possibly injure a child now illegal on the same basis?
• If the answer is yes, when will all those other products be banned and/or recalled? Is equity in the treatment of all products “important”?
• If the answer is no, then where do we draw the line?
• How relevant is it that no injuries have been reported?
• How many incidents are required before we declare a product or substance illegal or recalled? How many newspaper articles, editorials or CEH lawsuits are required?
• What responsibility do we have to be consistent in the administration of these rules?

Consistency, that’s important, don’t you think? If cadmium is now tacitly illegal because it might harm a child, do we have to make everything with the possibility of injury to children illegal?

Presumably, since no injuries to children from cadmium has been reported and the Washington Post confirms that doctors do not perceive cadmium as a serious risk (perhaps because it was not prevalent in house paint or in gasoline, hmmm), then anything with the same level of prospective risk would be illegal. That’s more or less everything from water to chicken bones to lead to ruthenium. [Pardon me, ruthenium, one of the world's most expensive and dangerous elements, is a-okay to include in children's products.] Why then aren’t we closing swimming pools which cause more than 250 deaths each year? What about water – you can drown in two inches of water. No more showers?

Is there something special about cadmium, besides that it has appeared in an Associated Press article?

The mania over the prevention of possible injury has turned the business environment into a feeding frenzy that will drive the business community down, down, down. Is that in anyone’s interest? Will we all be safer if we have nothing to buy?

Please consider that the House Energy and Commerce Committee has today weighed in on the Toyota recall. Yes, the same Henry Waxman who is torturing our industry has now turned his talons and sharp teeth on Toyota. Toyota enjoys one of the finest reputations for quality and service in the world. It is renowned as a business leader – and proactively took strong medicine in its gas pedal recall. This is not enough for the venomous Democrats who hate businesses. They need to dig deeper and perhaps damage Toyota enough to help GM and Chrysler, owned by the U.S. government and unions. Bringing the great low, that’s the new American way of the Democrats. It makes me SICK.

I want to close with a note about cows – did you know that cows are killers, too? Yes, they are – the New York Times reports:

“The image of cows as placid, gentle creatures is a city slicker’s fantasy, judging from an article, published on Friday by the Centers for Disease Control and Prevention, reporting that about 20 people a year are killed by cows in the United States. In some cases, the cows actually attack humans — ramming them, knocking them down, goring them, trampling them and kicking them in the head — resulting in fatal injuries to the head and chest.”

COWS kill 20 people a year, cadmium has apparently killed ZERO. We are running pell-mell to ban cadmium from jewelry because a misguided newspaper article fueled panic. Are cows next? Should they be? If cadmium jewelry goes away and cows stay unregulated, will respect for our laws remain?

Respect for Congress, that’s another thing.

Read more here:
CPSIA – What Constitutes "Safe"?

General Comments:

The Guidance is generally helpful and clearly well-intended. This is a helpful change in tone that will be welcomed by the business community. I encourage the CPSC to keep working on the tone of its communications to rebuild trust with the business community.

As a general matter, I find that this guidance speaks with two voices, one focused on reasonableness and good judgment with the goal of safety, and the other focused on rule-following and a byzantine structure for compliance judgments that is divorced from concepts of safety. For instance, the guidance stresses the importance of third party testing of lead-in-paint on children’s products. The guidance includes an extensive section with very specific suggestions on how to accommodate lab testing for various paint scenarios (Sec. D), suggesting that the CPSC thinks that lab testing is absolutely required to assure compliance with this standard. Later, the guidance notes that “Painted non-children’s products likely to be used in the home and around children, and wet paint in the can also must comply but can be accompanied by a general certificate of conformity.” So, the CPSC apparently thinks it is essential to test SOME products for lead-in-paint that children will regularly encounter in the home, and as for the rest, they are prepared to trust the manufacturer. It also suggests a much lower sense of urgency on lead levels in those other products. From a safety perspective, one of these approaches must be right but they both cannot be right at the same time. How does the CPSC expect their rules to be respected (or understood) if they blow hot and cold on such an important subject?

There are other conundrums, such as conflicting uses of the term “reasonable certainty” and “reasonable assurance” when describing compliance. These terms have very different meanings and connotations. [The better term is "reasonable assurances" because "reasonable certainty" is an illogical term akin to "nearly precise".] In addition, at times in the guidance, the CPSC describes in great detail the factors that a reasonable manufacturer should weigh in making judgments, and then in other seemingly similar circumstances, articulates bright line compliance requirements. Bright line rules are almost certain to cause chafing, as there are so many different industries affected, and many companies have innovated in safety and supply chain processes designed to assure good quality. Specific bright line rules will offend innovators and will tend to force them to share or squander their proprietary efficiency gains. For instance, phthalate testing plans and frequency is something that should be left to the best judgment of manufacturers. Why? Because phthalates are additives not found in nature, and if the manufacturer’s supply chain has been trained to eliminate it as an additive, testing and retesting won’t find it. The incentive to run your business well is eliminated when you cannot capture the benefits of efficiency.

It would be my strong preference that the CPSC rethink this guidance from the perspective solely of a safe environment for children. As a starting point, the CPSC Staff must candidly decide if they think children are in danger now and describe precisely how they are in danger. The concept of “no safe levels of lead” has been debunked by CPSC Staff and even the Commission itself. To my recollection, no lead exemption request under Section 101(b) has been rejected for safety reasons, only for lack of flexibility in the statute. In addition, in last week’s brass bushings hearing, Commissioner Adler repeated the consumer group’s slogan “no safe level for lead” and then went on to state that the Learning Curve toy cars (subject of the exemption request) were perfectly safe to use even with a child at some hypothetical tipping point in blood lead levels. Thus, both CPSC staff and Commissioners concede that there are safe (tolerable) levels of lead. We need to move past sound bites and refocus on the real safety problems faced by children. Some of these problems probably involve lead (bio-available lead). I believe the agency can identify those risks that deserve attention, and would concede that the rest do not (at this time). This is crucial for a system of rules that will be respected by the stakeholders in the safety debate. Silly implementing rules lead to silly results, unfortunately; famously, the CPSC has “okayed” several metals for inclusion in children’s products that are KNOWN to be quite dangerous – all because they are also known to be lead-free. A set of rules focused on real safety considerations will be much better received and will be far more effective, too.

It is also worth noting that the complexity of this guidance will likely defeat its purpose. When it takes 31 pages to explain how to sensibly test your products, with two dozen FAQs to clarify the ornate rules, it is clear that something’s wrong. If the CPSC wants rules that will be understood by the “masses”, the rules must be simpler and more focused and manageable. It is important that to note that the regulated community will not put the time into mastering the nuances of these rules like the few interested parties have done for the last year. Rules that work are shorter and simpler. My preference would be rules along the line of the factors listed in B.4 coupled with a requirement that manufacturers exercise good faith, make best efforts to comply and use reasonable or best judgment in making decisions. This both describes how a best-of-class enterprise thinks through safety issues and creates a basis for the CPSC to take action against “bad guys”. The rules can sacrifice some complexity and even some coverage in favor of ease of understanding in order to assure practical effectiveness.

Specific comments:

a. The Five Steps approach to designing a “reasonable testing program” creates a mega-bureaucracy, but to what end? Is this being created because the CPSC thinks it is necessary to solve a known safety problem or crisis, or just to accommodate a badly-written law? I think it’s the latter, and thus I believe it is appropriate to consider the new mega-bureaucracy to be a misdirected tax we will pay (to testing companies and others) annually. I think that’s bad government policy, as I think taxes (if necessary) should be paid to the government, not to private parties. Notably, the five steps do not include any advice on supply chain management. The issues in supply chain management (addressed in part in a different list in B.4.) are the source of most non-design legal compliance issues. A testing-focused set of guidelines is unlikely to change safety statistics, in my view.

b. I am blown away by the list of items subject now to GCCs outside children’s products. This completely escaped my attention previously. I think this will shock a lot of people. Again, this is a most unwelcome creation of new bureaucracy that is unlikely to serve any safety purpose. It is not designed to solve a real problem and thus cannot be justified.

c. The guidance makes the following distinction: “regulations concerning reporting, recordkeeping, inspections,: guaranties, certification, or tracking labels are not ‘similar’” but “any requirement of a rule, standard or ban under another act enforced by the Commission other than the CPSA that requires a warning or instruction, or specifies the form thereof, is similar”. How are manufacturers supposed to figure this out? What’s an “instruction”? Why is a “tracking label” not “similar” but a “warning” is “similar”?

d. In the section entitled “Will the Commission Require General Conformity Certification that a Product is Not Subject to a Ban?”, the guidance articulates a rule that everything within a class of products subject to a ban must be tested to back up a GCC. This will significantly increase costs but may not contribute to safety. The better rule is again to leave it to the reasonable judgment of manufacturers, as this will retain a focus on compliance, rather than testing for compliance. Overtesting, for instance for phthalates, will hurt small businesses disproportionately. If a business can organize its affairs to comply, they should be rewarded, not subjected to the same costs of companies less capable of managing their compliance obligations.

Overtesting and other bureaucracy that is not focused on safety will tend to punish U.S. small businesses in the international marketplace. Many companies, like ours, make a significant market outside the U.S. where our competitors do not have to follow U.S. rules to compete in those foreign markets. Overtesting for the U.S. market, or barriers like retesting for changing suppliers, will tend to create a long term cost advantages for foreign companies in foreign markets, reducing the ability of U.S. small business to enter foreign markets or remain competitive there. [Some members of the toy industry are advocating for international harmonization around U.S., rather than attempting to get U.S. standards and practices to become more rational. This "race to the bottom" can do tremendous damage - we need to rise above and set up a system that works but costs a lot less.]

e. The guidance should differentiate treatment of ink under the L-I-P rules and should state plainly the basic rule that if the can says “ink”, it’s ink and is not subject to the L-I-P test requirements.

f. The rules on retesting for a change in manufacturer need to be loosened. The guidance strongly favors mass market companies for their economies of scale and creates a barrier preventing or inhibiting small volume manufacturers from lowering their manufacturing costs. It goes without saying that lowered costs cannot sacrifice legal compliance or the duty of care toward consumers. It rarely does, in fact. The requirement for retesting will significantly hurt small businesses, however. It is important to note that changes in manufacturers is the most common reason for a change in components. For companies with stable product lines, swapping of components may not be very common. In our business, it is rare to change a component and not change the factory. Thus, we will gain little advantage from the rules focused on switching out components.

g. In Section B.2, the guidance strongly encourages annual testing. This will hurt small businesses. Our company’s focus is on producing safe and legally compliant products. We tend to focus on those issues that might affect safety or legal compliance. In our case, few things change in our manufacturing processes that would affect either safety or compliance over time. Thus, annual testing is a waste of money and rarely provides useful information in the administration of our business. If you test and test and test and get the same results each time, what is likely achieved by the next test? Again, the guidance should be focused on substantive safety compliance, not substantive testing compliance. The ONLY solution that will work for all companies in all circumstances is a rule dependent on good faith and best judgment. The principles outlined in B.4. form a good starting point on principles of supply chain management for this purpose.

h. The concept that someone can track the myriad different testing cycles by the components in a product, for most businesses, is a fantasy. In addition, the guidance notes that it may make sense to simply retest the whole product on a regular schedule “a means of simplifying cost, administrative burdens, or other factors.” In other words, the CPSC concedes that the market will not likely accept this relief. The scheme is unworkable as a practical matter. The CPSC should not put out rules it knows won’ t work.

i. Small volume is not best described as 10,000 units. Remember, there are 300 million people living in this country and more than 100,000 elementary schools. TRU won’t sell a product that sells only 10,000 pieces per year in its stores – and that’s just one outlet. The better definition would be 100,000 pieces or at a minimum, 50,000 pieces.

j. The guidance confuses the purpose of testing for compliance with the purpose of MAQL testing/inspections. Testing for MAQL (Minimum Acceptable Quality Levels) requires a MILSPEC sample size. This is appropriate because you are usually looking for defects in manufacturing, not legal compliance issues. In my experience, most if not all defects that have legal compliance implications are managed adequately with a single sample. Think of lead-in-paint, for instance. Multiple samples pulled from the same lot will NEVER produce different test results unless there are two or more sources of paint being used. That’s so rare and unexpected that it cannot justify regular testing of multiple samples. As with most of this guidance, the variance from the standard approach should only be justified by a real need, nothing less.

k. I must admit that while I find the rules on component testing helpful, I cannot help but think that they are making the CPSIA testing regime into a sham. A thick bundle of component tests performed at different times, in different labs, for a patchwork quilt of standards, will defeat the CPSC’s, Customs’ and our customers’ best efforts to understand them. If the purpose of the testing is not to communicate information, then what are we trying to achieve? The absurdly complex result from the component testing rules may bring relief to small businesses but at a high cost – by turning the entire testing scheme into a “check the box” exercise for manufacturers, dealers and regulators. If that’s what this is all about, why is anyone contending that children are not safe and need all these tests to be “safe”? This scheme is simply a by-product of writing rules to implement a mis-focused law, resulting in misguided rules that don’t make a lot of sense for their original purpose, rendering the entire system an embarrassing mess. Rather than burn in a terrible legacy of high costs, incomprehensible rules and test reports that cannot be interpreted, why not rethink the system from scratch and come up with rules responding to real, known problems, and leaving everything else to the best judgment and good faith of manufacturers? After all, without any additional regulation by the CPSC, every manufacturer is already subject to a common law duty of care. Why not simply describe minimally some basics of a duty of care and let the market sort out the rest, reserving the right to regulate in greater detail as real dangers are identified?

l. The sample size rules on lead-in-paint will not work for products purchased through trading companies. This is a somewhat complex subject that requires more details than I can provide in this space right now (it’s late!). Again, there needs to be some recognition that the general purpose of the legislation is to get people to test for lead-in-paint. If so, why not leave the rules on this to the best judgment of manufacturers when facing the de minimus paint issue? These instances are not likely to be true human health issues anyhow. The CPSC should also consider a de minimus rule on lead-in-paint to avoid the massive and wasteful losses from recalls like the Sarge cars in 2007 (over 400,000 units recalled because of two bad cans of paint used for detailing the cars). If you can’t obtain enough paint from one sample to perform the test, perhaps the amount of lead at issue is simply not worth worry about!

m. The guidance (logic) on one-of-a-kind products (which allows the manufacturer to exercise judgment as to whether versions are “the same product”) should apply to all manufacturers and all products. That is, manufacturers should be free to exercise this judgment on all products to simplify their testing without making any compliance sacrifices. This is something they can likely do with great insight. Consider, for instance, a manufacturer of 3-D topographical maps: do they need to test each different map or can they consider each variant the same “product”? The rules should permit this reasonable judgment by ALL manufacturers.. This will save many companies a lot of money. They are waiting for the CPSC to say it’s okay, and then they can start grouping test reports to save money. This will be a big win for small businesses, if accepted by the CPSC.

n. The CPSC should put out a FAQ about the formation of groups for testing purposes. In other words, they should bless companies or trade associations testing on behalf of groups of users of components or materials.

To sum up, the rules are helpful but would be much better if refocused on real safety issues, if shorter and less complex, and if they were more reliant on the good faith and best judgment of manufacturers based on common sense principles of duty of care.

Read more here:
CPSIA – Testing Guidance Comments

First, it is okay to incorporate as much lead as you want in your product, provided that it is not “intended primarily” for children: “The Commission is often asked what products must comply with the lead content limit, i.e., what is a ‘children’s product’ under the law. The answer is anything that is designed or intended primarily for a child 12 years of age or younger. ‘Primarily’ is the key word used in the law. Not everything a child uses or touches must meet the lead content limit, only those things designed or intended primarily for a child 12 years old or younger.” So, this means that the lead limits only apply to products intended “primarily” for children, and does NOT apply to products that children might use but aren’t aimed at the children’s market. [This is the dilemma in the brass bushings case.] Regulation of children’s products exists in its own little world, and hazards that exist within that market don’t exist outside it – is that it?

The CPSC will make a determination about this intent based on what you say or what you and others think about your product: “We consider how the product is marketed as well as what the manufacturer has said about the product (if reasonable) and whether consumers commonly recognize the product is being intended for a child 12 or younger.” Given that the CPSC is supposed to protect consumers from untoward product hazards (hence the agency’s name), I think it is fair to conclude that the CPSC has decided use of lead is only dangerous if the leaded product is intended for children. Intent apparently affects the physiological impact of lead. Interestingly, this is also the case with phthalates. Perhaps these materials were banned from children’s products because they can be activated by mind control, which is clearly dangerous.

I find the CPSC’s position compelling, as it suggests that perhaps the rules for small business under the CPSIA should be different. Many people have suggested to me that we should demand different rules for small business. After all, small businesses are severely and unfairly penalized under the new law – perhaps small business should get a pass? I have always said “no” on the grounds that parents are unlikely to forgive injury based on who caused it. Injuries are bad, whether caused by a big business product or a small business product. Therefore, it seems imperative to me that one (rational) set of rules needs to apply to everyone.

If, however, lead is okay if delivered by pen (“. . . most consumers would not consider an ordinary ball point pen as being intended primarily for use by a child 12 years of age or younger”) but not by way of an electrical cable in a potato clock, then perhaps we can rethink the other rules by analogy. Thus, this new CPSC position paper suggests that it might also be okay for certain kinds of businesses to poison kids. Pen companies, for instance, are apparently unrestricted – your Bic can be made of pure lead, that’s fine with the CPSC. By this same pretzel logic, I think it is reasonable to hold that small businesses are exempt from the law. Why not?!

In the same document, the CPSC also reiterated their excellent advice on materials that can be included in children’s products without testing for lead. They chose to remind us that our old friends palladium, rhodium, osmium, iridium and ruthenium are okey-dokey in children’s products. The fact that these materials are well-known to be poisonous, explosive and made from spent nuclear fuel rods did not apparently deter the CPSC. I know I am not a “safety professional” but I would think that at least some of these materials are hazardous substances under the FHSA, presumably making them poor candidates for exemption from the CPSIA. Given that these materials continue to appear on the CPSC’s exempt list suggests that I must not fully appreciate their safety benefits . . . .

Of course, the CPSC’s permission to use these materials on the grounds that they are lead-free seems remarkably out of touch with reality. Each of these materials, like other permitted materials like surgical steel, certain stainless steels, gold, silver, platinum and titanium, as well as diamonds, rubies, sapphires, emeralds and natural or cultured pearls, is absurdly expensive and in many cases, quite rare. It may sound good to say that the market is full of available alternatives, but if they are ridiculously expensive or hard to obtain, how is that any different than giving us permission to use pixie dust or krytonite? As a practical matter, not at all.

Someday, I wish the CPSC would issue practical advice that made sense to me. Once upon a time, I actually thought our nation’s safety laws were rational, understandable and predictable. Nowadays, they are riddled with traps for the unwary and require teams of people to interpret and administer them. The implementing rules are detached from any semblance of the reality of the marketplace: “The products on this list are all things the Commission has determined do not contain lead over 100 ppm, which is within the allowable 300 ppm limit. Thus, they will comply with the law (and must always comply) and, therefore, do not need testing and certification. They do not need to be tested by a third party laboratory to prove they are, in fact, made of something on the list, and they do not need to be tested to prove that they meet the lead content limits . . . . Some retailers may want manufacturers and importers to test and certify their products, but those tests and certificates are not required by the Commission for the materials or products on the list.” That makes it fine, I guess – the CPSC has had nothing to do with this “mysterious” phenomena.

As long as the CPSC thinks it is okay to wear blinders while doing its job, we will continue to get rules describing the legal and illegal ways to poison children and other safety conundrums. I am tired of it, what about you?

Read more here:
CPSIA – CPSC Isn’t Interested in These Ways to Poison Children