Tuesday, May 31, 2011
CPSIA - Illinois Keeps Its Priorities Straight: Meaningless Legislation
Thanks heavens for politicians!
Tuesday, May 24, 2011
CPSIA - AAP's Campaign of Lies on CPSIA Amendment (ECADA) Continues
It is worth observing that there is no doubt, and never has been any doubt, that lead is a neurotoxin and is capable to harming children. I think that's a given. The AAP letter gives considerable air time to remaking this point over and over again. Got it, thanks. What the AAP cannot do, and never has done, is prove a LINK between the presence of lead-in-substrate in children's products (shoes, educational products, books, ATVs, pens, bikes, t-shirts, shoes and so on) with actual injuries. Nada, nothing. Instead, they emphasize the "danger", sometimes lapsing into fantastic arguments calculating "losses" based on assumed and undocumented injuries, but NEVER do they address the subject of causation or nexus.
A good example of AAP tall tales is from their May 11 letter:
"The potential impact of lead in children’s products is real. For example, in 2007 and 2008, over 9.8 million pieces of children’s toy jewelry were recalled for excessive levels of lead. If just one-half of one percent of these items caused lead exposure in a child, 49,000 children would have been affected. If each of those children lost one IQ point – which can occur at levels of exposure below 100 parts per million – the economic burden of that lead exposure would be at least $409 million just in lost lifetime income. Health economists estimate that every time average blood lead level increases by a small amount across the children born in any given year, $7.5 billion is lost in potential earnings for those children."
But the AAP cannot deliver up even one such victim. All such calculations are therefore pure fantasy. Or should I say pure ignominy?
Today's letter is no better. See below with my annotations in red.:
May 24, 2011
The Honorable Fred Upton
Chairman
Committee on Energy and Commerce
U.S. House of Representatives
Washington, DC 20515
The Honorable Mary Bono Mack
Chairwoman
Subcommittee on Commerce, Manufacturing and Trade
U.S. House of Representatives
Washington, DC 20515
Dear Chairman Upton and Chairwoman Bono Mack:
As experts in the field of pediatrics, environmental health, and toxics, we would like to express our deep concern over the consideration of legislation that would have the effect of permitting more lead in toys and children’s products. [This is a LIE - ECADA does not permit "more lead in toys and children's products".]
Lead is a potent toxicant that can have a range of adverse effects on children’s brains and bodies. Low lead levels cause a wide array of negative effects, including cognitive, motor, behavioral, and physical harm. Even at very low levels, lead has been demonstrated to cause the loss of IQ points in children. [AAP citations call into question cause and effect, noting the many factors involved including self-selection.] Children with elevated blood lead levels are more likely to experience attention deficit and reading disabilities, and to fail to graduate from high school. [They are also more likely to live in poverty, in older housing, in inner cities and eat paint chips.] Researchers have identified associations between lead exposure and increased aggression, commission of crime and antisocial or delinquent behaviors. [Ditto] Other effects include abnormal balance, poor eye-hand coordination, longer reaction times, and sleep disturbances. At high levels, lead can be fatal. [Can the AAP show me an example of ONE CHILD who died or was injured from lead-in-substrate EVER? Apparently not - four Congressman tried to get the same information during the April 7th House hearing without success.] Lead accumulates in the human body and is stored in the bone, so multiple low-level doses can quickly result in harmful levels. For all of these reasons, our nation has for decades pursued a multi-faceted strategy of reducing children’s exposure to lead from all sources, including air, paint, soil, food, water, and the full range of consumer products. [The AAP cites a CDC publication in their May 11 letter on lead in which the CDC points to lead in paint, interior dust, exterior dust and dirt and lead in tap water.] To date, science has not been able to identify any safe level of lead exposure for children.
In 2008, Congress passed legislation that recognized the devastating effects of lead on children’s health and strictly limited lead content in toys and other children’s products. The Consumer Product Safety improvement Act protected children up to the age of 12, thereby covering the full period in which the vast majority of children will experience both rapid brain growth and the behaviors that increase lead exposure. [Human factors experts at the CPSC have long acknowledged that mouthing behavior ends at about age three. Mouthing behavior over age three is unusual and considered age-inappropriate, meaning that it is the responsibility of parents and caretakers to monitor and manage such behaviors to the extent they occur.] The law also phased in limits on lead content, with the final stage of that limit scheduled to take effect this August. That restriction of no more than 100 parts per million of lead in children’s products is expected to all but eliminate the possibility that exposure to a single product could cause the loss of one IQ point. [The AAP's assertion that there is a "possibility" of a loss of an IQ point from an interaction with lead-in-substrate in a children's product is purely conjectural and without basis in fact. Their persistence in advancing this argument without proof must be considered evidence of an intent to deceive.] These provisions represent critically important protections for children’s health and are a vital component of a comprehensive strategy to reduce lead exposure from all sources.
[Interestingly, neither the CDC nor the EPA take this position. In fact, the EPA notes: "First and foremost, the Agency faces the difficulty of determining the level at which to set the standards given the uncertainties in information on cause and effect--what environmental levels in which specific medium may actually cause particular blood lead levels that are associated with adverse health effects. The Agency has tools, which are only generally consistent, that show that certain increases in environmental lead levels are associated with certain increases in blood lead levels. Given the range of uncertainty shown in its analysis supporting the establishment of a hazard level under this rule, EPA has developed a technical analysis that considers hazard standards for dust and soil at the lowest levels at which the analysis shows that across-the-board abatement on a national level could be justified. EPA recognizes, however that for any levels of lead in dust or soil judgment must be exercised as to how to treat the medium, and interim controls as well as abatement could be effective. . . . Thus, if EPA were to choose standards that are too low, the public could be unable to distinguish between trivial risks at the low levels of lead from the more serious risks at higher levels. This could result in clean up for little to no health benefit, or conversely, it could result in almost no clean up because persons would question the credibility of the ‘hazard' determination."]
Given the extreme difficulty or impossibility of eliminating children’s exposure to lead in our air, soil, water and food, it becomes even more imperative to limit lead from those exposures we can control, such as children’s products. [Having never provided any nexus between trace levels of bound-in, insoluble lead-in-substrate in children's products and any known health risk, this sentence is either a lie or intentionally misleading. The AAP could resolve all such matters in its favor if it ever proved its case. Over the past four years, it has failed to do so.] We urge you to maintain strict limits on lead in all parts of toys and products meant for children up to the age of 12 years.
Signed by 100 "experts"
CPSIA - A Malefactor Exits Stage Right
But now one of the true movers and shakers behind the CPSIA has chosen to find other things to do. And I am speaking of the notorious Cindy Pelligrini of the American Academy of Pediatrics. Cindy's last day to create havoc at the AAP is June 3rd; after that, she takes her act over to the March of Dimes. [What is the lead content in dimes anyhow?] Cindy deserves special mention, right up there with the Queen Bee herself Rachel Weintraub, as responsible for the mess we all find ourselves in.
I have discussed Ms. Pelligrini in this space numerous in the past.
- Here is Cindy Pelligrini ghosting federal testimony and intercepting questions for its purported author, the estimable Dr. Dana Best. Dr. Best is a real live doctor. Ms. Pelligrini told me she holds a degree in political science. . . .
- Here is Cindy Pelligrini arguing against risk assessment because it would be too BURDENSOME on the CPSC. I practically weep over her compassion for the regulators! She also is the one who promoted the notion of background "contamination" of lead at 40 ppm (as if the presence of a naturally-occurring element is contamination), lower than the lead content of the dirt in Mr. Obama's garden. [Ibid.]
- Here's Cindy Pelligrini and the AAP misquoting or misstating the data from their own cited sources on lead poisoning. I guess the truth is what you make of it.
- Here is Cindy Pelligrini admitting that she is using the CPSIA strictures to achieve a different end that has nothing to do with lead poisoning, namely the tacit ban of youth model ATVs. Is manipulation and distortion less offensive if you brazenly admit it?
Wow, that's a hard act to follow! The pressure's on Rachel now . . . .
As a fitting tribute to Ms. Pelligrini, I offer up quotes from scholarly articles cited in a May 11, 2011 lead scare email she authored with an AAP associate. Most of the citations were not provided with links, perhaps to make this exercise more difficult. Sorry, Cindy, I cracked the code! Here are a few nuggets:
a. "Multivariable analysis indicated that residence in older housing, poverty, age, and being non-Hispanic black are still major risk factors for higher lead levels. . . . Risk of lead exposure by year housing built defined as follows . . . 1999–2004: low risk, built 1978 and later; medium risk, built between 1950 and 1977; high risk, built before 1950." Jones RL, Homa DM, Meyer PA, Brody DJ, Caldwell KL, Pirkle JL, Brown MJ. Trends in Blood Lead Levels and Blood Lead Testing Among US Children Aged 1 to 5 Years, 1988–2004. Pediatrics, Mar 2009; 123: e376 - e385. [Apparently, old homes come equipped with children's products with dangerously high lead content. How could there be any other possible explanation for this data?!]
b. "CDC is conducting several activities to focus efforts on preventing lead exposures to children. First, beginning in 2003, CDC required state and local health departments receiving funding for lead poisoning prevention activities to develop and implement strategic childhood lead poisoning elimination plans. Second, CDC and its federal partners, the Department of Housing and Urban Development and the Environmental Protection Agency, launched new initiatives to control leadbased paint hazards in the highest risk housing, addressing where successive cases of lead poisoning have been identified. Third, CDC and other federal agencies are developing a systematic and coordinated response to identify and eliminate nonpaint sources of exposure (e.g., lead jewelry, food and traditional medicines, and cosmetics). . . . The most common high-dose sources of lead exposure for U. S. children are lead-based paint and lead-contaminated house dust and soil." Advisory Committee on Childhood Lead Poisoning Prevention. Preventing Lead Poisoning in Young Children. A Statement by the Centers for Disease Control and Prevention. August 2005. [What, no reference to children's products?! Does the CDC know what it's doing? Come on, there's no safe level for lead . . . .]
c. See my blogpost of May 11 for an analysis of this article. Self-selecting factors may explain the data on lead poisoning, not the hazard itself. Hmmm. Chen A, Dietrich KN, Ware JH, Radcliffe J, Rogan WJ. IQ and blood lead from 2 to 7 years of age: are the effects in older children the residual of high blood lead concentrations in 2-year-olds? Environ Health Perspect. 2005;113(5):597-601.
d. "Lead can be found in high concentrations in three media to which children may be directly or indirectly exposed: paint, interior dust, and exterior soil or dust. This section discusses the distribution of lead in these media and their relationships to one another and to blood lead levels (BLLs) in children (Figure 2.1). Lead in tap water, generally a lower dose source of exposure, is also addressed." Centers for Disease Control and Prevention. Managing Elevated Blood Lead Levels Among Young Children: Recommendations from the Advisory Committee on Childhood Lead Poisoning Prevention. Atlanta, GA: Centers for Disease Control and Prevention.; 2002. [Again, the CDC screws up - no apparent awareness of the plague of contaminated children's products. So dopey, good thing we have the AAP and CFA to ensure that the 100 ppm lead standard is imposed on lead-in-substrate in children's products. It's a mere detail that no one has EVER produced a single victim of lead poisoning linked to lead-in-substrate in any jurisdiction at any time anywhere in the world.]
e. Article discussing the later consequences of lead poisoning. Does not discuss sources of lead poisoning. "Residual and unmeasured confounding are always of concern in observational studies where all possible covariates cannot be assessed and those available are not measured with equal precision. . . . The inclusion of neuropsychological variables examined in this sample such as measures of executive functioning, attention, and IQ may have amplified the predictive vigor of the models. . . . The possibility that early exposure to Pb may lead to a higher risk of antisocial behavior in later life through its effects on neuropsychological functions is interesting and will be the subject of future analyses of these data. Variables independently associated with measures of antisocial behavior included maternal intelligence and lower birth weight. The association with lower parental IQ was not unexpected and a few studies suggest that delinquency is related to medical complications at birth." Dietrich KN, Ris MD, Succop PA, Berger OG, Bornschein RL. Early exposure to lead and juvenile delinquency. Neurotoxicol Teratol. Nov-Dec 2001;23(6):511-518 [Emphasis added] [In other words, lead might explain the social dysfunction of some kids. Then again, so might many other uncontrollable variables well-beyond the ability of this study to analyze or even detect. Clear as mud . . . .]
f. A classic "garbage in, garbage out" study, this article argues that a loss of an IQ point results in a corresponding loss of about 0.1 years of schooling. If, however, you note the conclusions or suspicions in the article referenced above in par. c above, you may conclude there may well be other factors at play, such as family income or poverty, age of housing, neighborhood setting, other family dynamics (such as educational background), and the basic intelligence of the kids affected by lead poisoning. Kids presenting as lead poisoned may be the least likely kids to be successful in school for other reasons separate from lead poisoning - in other words, lead poisoning might be a symptom of a larger problem, not the problem itself. The article does not sonsider this possibility. Salkever D. Updated Estimates of Earnings Benefits from Reduced Exposure of Children to Environmental Lead. Environmental Research, 70:1-6: 1995.
I could go on and on - Ms. Pelligrini and her associate provide bundles of citations all making similar points.
Ms. Pelligrini leaves behind a record replete with misleading conclusions and head fakes. In the process, she accomplished little for kids but managed to ruin many businesses, drive entrepreneurs into other markets, kill jobs and eliminate valued products that kids, families and schools needed and wanted. She had a willing accomplice in the Dems who employ populism to get reelected. Damn the science, we need to make kids safer . . . even if we have no idea what that means!
As I noted earlier this year, Walter Lippmann, founding editor of The New Republic and winner of the Presidential Medal of Freedom1964, once cited the components of wartime mythmaking as "the casual fact, the creative imagination, the will to believe, and out of these three elements, a counterfeit of reality." Counterfeit of reality, that's our Cindy. Cindy, we'll miss you!
Not.
Monday, May 23, 2011
CPSIA - The State of Illinois PAYS People to Do This
And how is our wonderful State, the Land of Lincoln, spending its precious few resources these days? Well, a top priority is the lead labeling law. Ah, that old chestnut! Apparently, the scourge of lead has not been sufficiently snuffed out in Illinois. The absence of injuries, the sharp drop in recalls, the asphyxiating federal requirements are all inadequate around here to keep kids "safe". Our civic leaders have already put in place the toughest and most unreasonable lead labeling law in the country, out Proposition 65'ing even the real Proposition 65. Never content to leave "well enough" alone, they are going back to the well.
So our paid public servants with apparently very little to do have chosen to revise AND TIGHTEN the Illinois lead labeling law. See the attached working draft for your amusement (or nausea). They are extending it to all coatings - get your tests a-ready! - and have added a notation in the "warning" label to indicate that the product actually complies with federal standards. Yes, the ultimate mixed message - dangerous yet safe, all at the same time! - consumers will no doubt appreciate this extra effort by regulators. The law is now much more complex and impenetrable, too. Lucky us.
And why did the estimable Lisa Madigan, our Attorney General, demand this change in law? Gotta get elected right? If kids aren't made safer every day, whether science is involved or not, who needs the AG's office? No injuries motivated this change, just a basic lack of understanding of science and a passionate need to deceive the public.
Lisa Madigan's paycheck is among the bills that Illinois pays promptly, by the way. My tax refund isn't on the same list of priorities.
Welcome to the Land of Lunkheads. Illinois, you shining star!
Wednesday, May 11, 2011
CPSIA - AAP Publicity Campaign Tries to Block CPSIA Amendment With Half-Truths and Worse
Here is their first blast email - with my replies noted. I will post more of their pap as it arrives.
As the Energy and Commerce Committee considers issues related to the safety of children's products, the American Academy of Pediatrics is pleased to provide background information about lead and its effect on child health. For more information, please contact Cindy Pellegrini (cpellegrini@aap.org) or Kristen Mizzi (kmizzi@aap.org) at the American Academy of Pediatrics at 202/347-8600.
Lead: Frequently Asked Questions
Lead is a soft, heavy and malleable metal that occurs naturally in trace amounts throughout the environment. Due to its abundance and easy workability, it has been used for thousands of years in plumbing, production of glass and crystal, and the manufacture of a wide range of consumer products. Following are some common questions about lead and its impact on children’s health.
What are the effects of lead exposure on children’s health?
Lead is well-established as a potent neurotoxin and a particular threat to the developing brain of the fetus, infant, and young child, with documented negative effects on behavior and permanent loss of IQ points. Lead causes permanent, irreversible brain damage. Even at very low levels, lead is known to cause loss of IQ and intellectual function. Children with elevated lead are more likely to have problems with attention deficit and reading disabilities, and to fail to graduate from high school. Investigators have identified associations between lead exposure and increased aggression, commission of crime and antisocial or delinquent behaviors. At high levels, lead exposure can be lethal.
@@@@RW - Lead is a known neurotoxin, yes, but exposure to lead does NOT erase IQ points inevitably or permanently. Common experience indicates this, and so does science. Here, the AAP is emphasizing that lead CAN do this, not that it WILL do so as a result of each exposure under all circumstances. The AAP cannot prove that lead ALWAYS has this effect nor can they link lead poisoning to the regulatory issue currently before Congress - namely, lead-in-substrate. Lead-in-paint is NOT at issue here. Elevated lead levels have NEVER been linked to lead-in-substrate - NEVER EVER ANYWHERE. Here the AAP is IMPLYING that lead can do this via lead-in-substrate, and relying on fear of the unknown (and a general societal ignorance of science) to achieve their political goal. Lead exposure from house paint, leaded gasoline and industrial pollution are the only sources of lead poisoning addressed or cited by the EPA or CDC.
Notably and shamefully, the AAP ignores or distorts its own scientific evidence in its venomous public relations campaign against the CPSIA amendment. As you will see from their later press releases, the AAP cites the following article: Chen A, Dietrich KN, Ware JH, Radcliffe J, Rogan WJ. IQ and blood lead from 2 to 7 years of age: are the effects in older children the residual of high blood lead concentrations in 2-year-olds? Environ Health Perspect. 2005;113(5):597-601. They do not provide a link, but I have it for you here. In this article, the AAP's assertion that lead inevitably erases IQ points is exposed as conjectural, not a universal truth. The Abstract of the article makes it clear that no declarative statement linking lead-in-substrate to loss of IQ points can be made other than that it is theoretically possible:
“Increases in peak blood lead concentrations, which occur at 18–30 months of age in the United States, are thought to result in lower IQ scores at 4–6 years of age, when IQ becomes stable and measurable. Data from a prospective study conducted in Boston suggested that blood lead concentrations at 2 years of age were more predictive of cognitive deficits in older children than were later blood lead concentrations or blood lead concentrations measured concurrently with IQ. Therefore, cross-sectional associations between blood lead and IQ in school-age children have been widely interpreted as the residual effects of higher blood lead concentrations at an earlier age or the tendency of less intelligent children to ingest more leaded dust or paint chips, rather than as a causal relationship in older children. [Ed. Note - In other words, the lower IQs found in children may be due to the fact that it may effectively be a self-selecting group. Hmmm, interesting finding.] Here we analyze data from a clinical trial in which children were treated for elevated blood lead concentrations (20–44 μg/dL) at about 2 years of age and followed until 7 years of age with serial IQ tests and measurements of blood lead. We found that cross-sectional associations increased in strength as the children became older, whereas the relation between baseline blood lead and IQ attenuated. Peak blood lead level thus does not fully account for the observed association in older children between their lower blood lead concentrations and IQ. The effect of concurrent blood level on IQ may therefore be greater than currently believed.” [Emphasis added]
The study notes later: "In neither analysis did we see evidence in the overall group or in the placebo group that blood lead at 2 years of age determined IQ at 7 years of age. . . . Thus, although it is attractive to look at change in IQ by change in blood lead when considering the effect of an intervention, modeling those changes simultaneously is complex and can produce results that are difficult to interpret." [Emphasis added] In other settings, this might be labeled an ADMISSION. Don't expect any such thing from the AAP.
I am sure the AAP never expected anyone to actually read their footnotes . . . .
What happens to lead in the human body?
The human body treats lead like calcium. Once ingested, lead is absorbed into the bloodstream and travels throughout the body, including across the blood-brain barrier. Lead is bioaccumulative; a percentage of absorbed lead may be stored in the bones, where it is bound tightly and may be released over the course of many years. A portion of lead will also be excreted from the body. The amount of lead absorbed, excreted or stored in the bone may depend on a number of variables.
@@@@RW - This is a critical point, and again, the AAP relies on innuendo and fear to sell an implication as an accepted fact. Common experience, even among children with elevated lead levels, indicates that it is the persistence of high blood lead levels that put children at material risk of lead poisoning and IQ loss. Here's another quote from the above article CITED by the AAP: "Among children with both prior and concurrent blood lead concentrations below the corresponding medians as the reference group, those with prior blood lead concentrations at or above median but concurrent blood lead concentrations below the median did not have a decrease in school-age IQ score. In contrast, children with concurrent blood lead concentrations at or above the median had roughly similar IQ decreases, irrespective of their prior blood lead concentration." [Emphasis added]
In other words, studies show that children with high blood lead levels that are later reduced to the normal range do NOT have reduced IQ levels. HOWEVER, if the high blood lead levels are allowed to persist in school age children, lower IQ levels can be anticipated. Who are these kids with high blood lead levels at school age? That begs MANY questions. Don't expect the AAP to address them.
While it is undeniable that some lead accumulates in some form in the body, the real question is how much and what is the lasting impact of that lead. On that question, the AAP is silent and certainly makes no effort to carefully consider and translate its own cited studies. Taking the opposing position to the AAP is not the same thing as touting lead as a health food. Lead is dangerous - the question is how is it dangerous and in what forms. In this case, we are dealing with lead-in-substrate; it would be helpful to only present data relevant to that topic.
Are some children more vulnerable to lead and its effects?
Yes, but it may be difficult to identify an individual child’s risk. Lead absorption is known to vary based on factors like a child’s age and nutritional status. At least one gene has been identified that appears to raise a child’s risk. Scientists are still working to identify sensitive windows of development where lead exposure may be particularly damaging.
@@@@RW - For the sake of argument, let's assume this is unambiguously correct - kids vary in their susceptibility to lead poisoning. Some are more susceptible, some are less. [The AAP provides no data on this point here.] Then consider how many children are currently living on Earth (more than 2 billion). And then consider the effect of mortality rates and "aging out" on the total population of children in the regulated age group over a period of decades.
If kids fall along a spectrum of susceptibility to lead poisoning and therefore some are very sensitive to it, and taking into account the MANY billions of children in the regulated age group worldwide over the past 50 years, WHY aren't there any documented cases of lead poisoning from lead-in-substrate anywhere at any time under any living conditions or otherwise? Four Members of Congress asked consumer group representatives this question at the April 7th hearing - and didn't get an answer. It's a good question. The absence of victims suggests that the range of susceptibility is not as great as the AAP wants you to believe (as a result of its innuendo and implications). It also suggests (proves?) that lead-in-substrate is not a health hazard in children's products.
How does lead enter the body?
Lead can be ingested or inhaled. Children may swallow paint chips, small parts, or other items that contain lead. In addition, lead can be released from products when they are mouthed, sucked, or licked. Lead may be found in dust and soil, and is present in measurable quantities in our air. Lead cannot be absorbed through the skin, but it can be ingested if it gets on a child’s hands and he or she then puts their hands in their mouth.
@@@@@RW - A mixture of undeniable facts and misleading innuendo. The AAP mixes up known and serious sources of bio-available soluble lead (paint, dust and dirt) and immaterial and unproven sources pf insoluble lead (substrates). Their narrative is designed to manipulate you into reaching the unsupported conclusion that it's all the same by providing only half the story. If the AAP were restricted to talking JUST about lead-in-substrate, this paragraph might not be as powerful or fear-inducing. This is the basic error in the original CPSIA panic - lead-in-paint was equated with lead-in-substrate by reactive people like Dick Durbin. At that point, all was lost.
Does it matter how lead gets into the body?
No. Once lead enters the human body, its behavior is consistent.
@@@@RW - This is patently UNTRUE. Bio-available lead, namely soluble lead that can be absorbed into the bloodstream, has a very different effect than lead bound into substrate. Lead-in-substrate has never been linked to health problems but soluble lead (lead-in-paint, lead-in-dirt from leaded gasoline, lead-in-air from industrial pollution) has a clear linkage. This misstatement is either carelessness by the AAP or a flat out effort to mislead. Draw your own conclusion.
Will the size of a product, or the concentration of lead in it, have an effect on how much lead is absorbed?
Very small items can have high lead content, such as paint chips or dust. Trace amounts of lead, enough to cause measurable brain damage, are invisible to the naked eye. Exposure to higher concentrations of lead will, however, more quickly lead to higher blood lead levels in children.
@@@@RW - Again, the AAP uses lead-in-paint and dust to make a point in a question about lead-in-substrate. This is irrelevant and misleading. They want you to believe it's all one-and-the-same. The final sentence is also unsupported. A very high concentration of lead in hard plastic will NOT lead more "quickly" to higher blood levels than a lower concentration of SOLUBLE LEAD in another form (say, dust or lead-in-paint). This is plain baloney and is not supported by scientific findings or common experience. The AAP should be embarrassed.
What’s considered a high blood lead level?
Blood lead level is measured in micrograms per deciliter (mcg/dL). In general, research currently indicates that 1 IQ point is lost every time a child’s blood lead level rises 1 mcg/dL at levels in the range of 3 to 10 mcg/dL. Above a level of 10 mcg/dL, IQ loss occurs somewhat more slowly, but other health consequences may appear, such as interference with iron metabolism. The Centers for Disease Control and Prevention recommends that the source of lead exposure be investigated for any child with a blood lead level of 10 mcg/dL or higher.
@@@@RW - The AAP does not correlate actual data and science with their declarative statements and misleading remarks. Consider their claim that "[in] general, research currently indicates that 1 IQ point is lost every time a child’s blood lead level rises 1 mcg/dL at levels in the range of 3 to 10 mcg/dL" with the above-referenced scientific study cited by the AAP. The AAP's statement over-promises by a wide margin. Their clear implication is that high blood lead levels are like an IQ ratchet wrench but the literature speaks more carefully and notes many problems with reaching black-and-white conclusions. This may be why you did not seem to lose too many IQ points fastening lead fishing lures with your teeth as a kid. Someone once left a comment in my blog that they must have lost thousands of IQ points from lead over the years. This is what they meant.
I urge you to be suspicious of the assertions of pseudo-scientists who don't back up their big claims. If the claims are true, then there should be no reason not to trade in data. Hey, AAP, where are all the victims? Can you hear me yet???
What are current average blood lead levels in the United States?
The removal of lead from gasoline and paint in the 1970s resulted in a precipitous drop in child blood lead levels. Between 1976 and 1980, the average blood lead level for children age 1 to 5 years was 14.9 mcg/dL and blood lead levels over 40 mcg/dL were not uncommon. Today, the average blood lead level for children age 1 to 5 years is 1.5 mcg/dL (CDC NHANES, 2007-8). However, about one percent of children still have blood lead levels 10 mcg/dL or higher.
@@@@RW - This is the point Rep. Bono-Mack made at the February hearing. The last sentence is meant to scare Congress into believing that we do not know how children today come to suffer high blood lead levels - leaving the dark impression that it may be the fault of children's products. We do know the answer to this question, however - the EPA and CDC tell us that the causal agents are house paint, the consequences of leaded gasoline use and industrial pollution. It's certainly NOT lead-in-substrate. If it were, there might be at least ONE victim they could trot out. Those victims don't exist.
What is the treatment for elevated blood lead levels?
There is no treatment available for low to moderate blood lead levels. At levels of 45 mcg/dL and higher, physicians may recommend chelation, which involves administering a drug that binds to lead in the bloodstream. Chelation is not, however, effective at lower blood lead levels, and it carries risks of its own. Chelation does not reverse the damage done by lead to the developing brain.
@@@@RW - Interesting but irrelevant. This law is about lead-in-substrate. The AAP is not talking about a problem caused by lead-in-substrate here, so it's completely irrelevant to the matter at hand. It sounds creepy, however, so I can understand why they felt it necessary to mention it.
What is a safe level of lead?
Scientists have not been able to identify a safe level of lead in the human body. Research shows that lead causes harm down to very low levels, below which the science remains unclear.
@@@@RW - Whether there is or is not a safe level for lead is not relevant here. What is relevant is whether lead-in-substrate can harm children. The AAP has never proven it, just asserted it. There is no evidence that lead-in-substrate can harm children in any material or detectable way. Until the consumer groups can offer up something more persuasive than their usual declarative statements, they should be kept out of the room.
For more information, please contact Cindy Pellegrini (cpellegrini@aap.org) or Kristen Mizzi (kmizzi@aap.org), at the American Academy of Pediatrics, 202/347-8600.
Friday, April 8, 2011
CPSIA - If The CPSC Goes Out, Do You Think They'll Come Back???
But what about the CHILDREN, you say.
It's a horrifying thought. After all, with annual expenditures of north of $100 million per hyear and in recent times an obsession with children, the CPSC has managed to uncover one death allegedly tied to lead (swallowing a jewelry bangle) and three injuries tied to lead-in-paint over an 11-year period from 1999 - 2010. That's what you get for regulatory expense of more than $1 billion - four alleged injuries. Value for the dollar . . . .
In the last couple years, though, the federal government in its infinite wisdom has chosen to pass all regulatory cost increases on to YOU. Yes, in a new innovation making rising taxes obsolete, Congress raised YOUR costs by billions each year when it inflicted the CPSIA on America. I have previously presented an analysis based on Congressional testimony that estimates those costs at more than $5.6 billion each year. And I think that's low.
I know you're probably not a statistician, but what are the odds that lowering the ten-year results from four alleged injuries to zero alleged injuries would be considered statistically significant? I believe the answer is zero or very very low. $5.6 billion a year doesn't buy much, does it?
The scale of the threat was explored in a revealing moment yesterday when the infamous Rachel Weintraub of the Consumer Federation of America was asked by four different members of Congress for names or lists of victims of lead-in-substrate. She couldn't name any. Dana Best had no chance to answer such questions, because she bolted before questioning. I rather doubt the members were much in the mood to accept an answer of "jillions" anyway. I haven't had a chance to review the tape yet, but I understand Ms. Weintraub assured Congress in response to these queries that lead is a "silent" harm-doer. Rachel says there;s no way to tell . . . so I guess the implication is that we should assume millions of kids have been harmed. Possibly bazillions. Who knows?!
Has anyone considered the possibility that the injured children that only Ms. Weintraub and Dr. Best can see are IMAGINARY? Consider this argument: Rachel and Dana and their ilk have had three years to find a victim, any victim, at any time since Hector had pups. They have failed in this endeavor. Maybe Rachel and Dana didn't try, maybe they don't care. After all, they probably thinks they're right and who are we to challenge either of them. No response required. . . ..
But IF Rachel's right, why don't the numbers yield up MANY victims? It really shouldn;t be hard to find injured kids - which makes the failure to do so all the more galling. There are lots of children in the regulated age group - more than 50 million. That population is constantly changing because kids "age out". So if you look over a decade, say, you might be talking about 75+ million. What do these kids do? What all kids do. They play, they breathe, they eat, they ride ATVs, they lick bicycles, they suck on the ink end of pens, they consume fistfuls of rhinestones, the usual. Some of them oddly do extreme things. You are looking at a BIG population. Over a decade, that's HUNDREDS OF TRILLIONS of product interactions, some of them excessive. And yet there are no known victims. Hmmm. Perhaps this is a pretty low probability event. And not worth $5.6 billion a year in excess costs.
So when the CPSC goes out, will anyone notice? That;s a good question. It may be an experiment worth running. And if the world doesn't come to an end without them, perhaps Congress might find something new to cut when life gets back to normal.
There's no safe level of fear mongering, guys.
Your Friend,
The "Lead Doser"
Saturday, March 26, 2011
CPSIA - Remember the Victims (If You Can Find Them)
As an aside, there are actual poisoning risks in the world. As previously noted, the Japanese nuclear crisis seems pretty real to me. In the past 24 hours, the owner of the disabled Japanese reactors told the press that they evacuated one of the reactors (again) because the radiation level was now a mere 10 million times "normal" levels. As if to make the point that they are out of their depth, the Japanese utility later announced that it wasn't really 10 million times too high, just 100,000 times. It's always good to check your work.
In the U.S., we remain blissfully, almost quaintly obsessed with lead. Lead is THE problem we need to solve, apparently, according to the junior scientists who called themselves the 110th Congress. As far as I can tell, the CPSC has enthusiastically embraced this point of view.
Why?
Well, we have been told monotonously that there is NO safe level for lead. Commissioner Bob Adler wrote a 21-page treatise to "prove" the point (rebutted by yours truly here). And the consumer groups, ably represented by Don Mays of Consumer Union and Dana Best of the AAP, repeated the slogan in their February 16th testimony on the urgent need to reduce lead levels to 100 ppm. When the lead zealots speak of the dire need to protect against this "scourge", they never speak in terms of CPSC injury statistics. That makes sense. As I have documented, there have been fewer lead injuries in a decade than the fingers on your right hand.
But isn't this all about injuries? If there is REALLY no safe level for lead, shouldn't it be easy to find victims? Ahem, the consumer groups state that lead harms "silently". You can't tell you are being harmed, you see! When questioned about "victims", those few deigning to respond to my stupid questions (Jan Schakowsky and a staffer for a Senate Democrat) point to a meeting held in May 2008 with victims of lead poisoning. Nonetheless, they have never produced victim case histories and typically simply wag their fingers at me over lead poisoning.
I am no fan of lead or of lead poisoning, believe me, but I think I am entitled to an answer. If the object of the law is the prevention of childhood injuries, and if this May 2008 meeting was the critical basis for the push for the CPSIA, who were the victims at the meeting? How many victims were seen, and how were they poisoned?
Before we answer this question, it is important to note that the issue here is NOT lead-in-paint. As is well-known, lead-in-paint has been illegal for decades. Victims of lead-in-paint from products sold today are victims of violations of law. We are looking to find victims of lead-in-substrate. The over-arching regulation of lead-in-substrate is the source of the regulatory misery that befell ATVs, bicycles, pens, musical instruments, books, educational materials, rhinestones, t-shirts, shoes, and so on. Do these victims exist? No lead zealot or CPSIA apologist has ever produced even one lead-in-substrate victim in three years. Were they at the May 2008 meeting?
The Internet knows all. Parents of two childhood victims of lead-in-paint were present at the 2008 meeting, as identified in several press reports. See "Parents Visit Congress to 'Get the Lead Out' of Toys", as well as "Congress vs. lobbyists over tainted toys" and this transcript of the Lou Dobbs Show (May 23, 2008) thoughtfully provided by the plaintiffs lawyer front Center for Justice and Democracy. There is no mention of any child harmed by lead-in-substrate. Two victims of lead-in-paint spurred this legislation. That's it.
Without a demonstration that there are actual victims of lead-in-substrate in existence, the CPSIA has no proven factual basis. It's all pure conjecture. Playing fast and loose with the facts, the lead zealots have SOLD the idea that this law was necessary, all without PROOF. Perhaps in the heady days of 2007/8, the legislators didn't recognize the significance of the data problem. But today, members of the 112th Congress, facing the prospect of an amendment to fix the CPSIA, cannot afford the same ignorance. Constituents have been screaming for years now - and apparently with good reason.
The misuse of data, the zealots' twisting of fear of lead-in-paint into a blind fear of everything, got us into this mess. Questions need to be asked as the new amendment is processed. Why are we doing this? Who is really being protected here?
In desperation, the consumer groups are saying just about anything to keep their law in place. Spreading fear of bicycle licking and trombone playing is certainly not beneath them. Dr. Dana Best sums up the consumer groups' dubious, twisted "argument" for the need for a tightened CPSIA:
"An object containing 77 ppm of lead is capable of raising a child's blood lead level to a level that would result in the loss of one IQ point. . . . Ingestion of an item containing 300 ppm of lead would result in the loss of almost four IQ points . . . . When averaged across even a modest population of children, the public health harm caused by lead is significant. Considering that there are about 75 million children in our nation, impacting one-half of one percent of all children would mean an exposure of 3.75 million children. . . . For one million children, [the loss of lifetime income from one IQ point per child] would total over $8.3 billion." [Emphasis added]
Yet Dr. Best cannot deliver the goods to prove her farfetched theories and even more farfetched mathematics. Stating the danger in terms of 3.75 million possible victims is corrupt and immoral when you cannot deliver even one victim.
Let's cross our fingers that Congress is resolved to not be fooled again. If there is a hearing, ask for real data, real case histories, real proof.
I can't wait to hear about the kid who licked the ATV engine block and was poisoned by . . . lead? Give me a break.
Monday, March 21, 2011
CPSIA - Response to Questions by Nancy Nord (100 ppm Hearing February 16th)
Response to Commissioner Nancy Nord's Request
for Comment in the Federal Register
1. You stated reduction from 300 ppm in substrate to 100 ppm in substrate removes the margin of error for low tech manufacturers. Would you elaborate on this with some of your own testing experience?
When we consider the impact of the lower standard, we first ask how we would manage a failure. As (presumably) rational business people, we want to allocate our capital to maximize our returns, and thus, risks to those returns must be weighed and addressed as appropriate. We have tried to understand our risks under the new lower lead standard – and the results are not encouraging. Once a failure (failed test) is discovered, it is often incurable. A failed test on a completed item including an integrated failed component (e.g., a zipper) likely means a total loss under the CPSIA. Failures of components already subject to valid passing component tests cannot be ruled out and in fact, are likely to occur. Our inability to solve this problem for even trivial violations introduces a new and significant risk of random (unpredictable and uncontrollable) losses to our business.
The agency’s stance on re-testing is not encouraging either. The draft rules on re-testing in the “15 Month Rule” are best described as unworkable. The doubt raised over the consequences of a failed test under pending rules only elevates our concern over how we might deal with a failed test. At present, there seems to be few options. For this reason alone, the proposed reduction of lead standards to 100 ppm is extremely threatening.
Given the dire consequences of a failed test, we must assess whether we can control our supply chains and raw materials/components to always comply with the new lower standard. In my testimony before the Commission, I noted that 98.3% of our passing test reports in a two-year period (2701 CPSIA test reports) were compliant with the new standard. Unfortunately the 1.7% in the range of 100-300 ppm scatters randomly across our many products and components. Thus, we don’t know how to predict which components are prone to risk of non-compliance and the consequences of finding them at the wrong time can be devastating. [It goes without saying that 2701 tests in a two-year period is a strong demonstration of both the devotion of resources and the huge expenditures required by the CPSIA to obtain passing tests reports – continual clean bills of health, over and over and over again.]
Our testing results reveal two troubling trends. First, we have found a material number of our items with one or more components that fall into the 100-300 ppm zone, sometimes just barely above 100 ppm. For a “miss” of as little as 5 ppm of lead entombed permanently in a substrate, an entire lot can be relegated to the garbage heap. Failed components might be as insignificant as a label or a lens cap. We also know from experience that retesting the same unit or units from the same lot may result in a passing test report but do not anticipate that we will be afforded this option to “comply”. In any event, retesting to obtain a clean passing test report does not change the product. If this law is truly about safety, I fail to see what is being accomplished by piling up the test reports to the profit of the test labs. The occurrence of failures under the new standard for a few ppm of lead will raise our costs significantly.
Second, we have encountered significant variability in our testing results. I have attached three test reports as examples of the variability problem. The first report (submitted with my comments on the 100 ppm standard) shows the test results on a single piece of string from a mesh bag holding dominoes. We cut the string into ten pieces and then tested each segment. The lead content results ranged from 239 – 275 ppm. A representative of the bicycle industry gave similar evidence (wide variability in multiple tests on different parts of a single component) at the 100 ppm hearing on February 16th. In the attached test report on tape measures, we found lead levels in coatings in the same tape measure lot ranging from 79-97 ppm, which is more than a 20% variability range. Finally, I have attached three test reports showing yellow plastic substrate from the same lot of educational products at 23, 88 and 139 ppm lead levels. Our success in obtaining passing test reports will apparently depend on LUCK when lead levels are near the 100 ppm concentration. We don’t have a solution to this problem. In our experience, this problem strikes randomly and often absurdly. We have found, for instance, lead levels between 100-300 ppm on zipper housings on the inside of a sewn bag. Lizard tongues might be able to reach it but fortunately, none of our customers are lizards.
None of this randomness or massive expense can be tied to safety – just to the enrichment of testing companies and lawyers. I am hopeful that the Commission will see that action is needed to stop the reduction of the lead standard to 100 ppm to help preserve the value our company brings to schools and families throughout the United States.
Monday, March 14, 2011
CPSIA - What Does the CPSC Know that the EPA Doesn't?
I submit here EPA regulations on permissible lead levels in play yards and residential dirt. Pleae note that lead in dirt is soluble, so it actually presents a health risk to children. In 2001, the EPA implemented a revised legal/regulatory architecture to protect children from lead-in-paint and lead in the environment. The regulations (40 CFR Part 745) are entitled "Lead; Identification of Dangerous Levels of Lead; Final Rule".
I think this is an interesting rule because we sell sand and soil as part of children's science kits. Hmmm. The CPSIA restricts lead content in everything we sell, even fossils and rocks, hence our well-known lead labels. Does the EPA permit something that the CPSC forbids?
Guess!
Consider what the EPA said about its new regulations:
"EPA is also promulgating amendments to the regulations for leadbased paint activities under the authority of TSCA section 402 (15 U.S.C. 2682) and to the State and Tribal program authorization requirements under authority of TSCA section 404 (15 U.S.C. 2684). These changes are needed to ensure consistency among the various regulations covering lead risks under TSCA."
Consistency seems to be a concern of the EPA. How quaintly passé.
Nonetheless, the EPA seems to understand what is at stake for American children when it comes to lead:
"Reducing exposure to lead has been an important issue for EPA for more than 2 decades. Young children are especially vulnerable to the toxic effects of lead because their nervous systems are still developing and they absorb more of the lead to which they are exposed. Many of the health effects associated with lead are thought to be irreversible. Moreover, the effects at lower levels of exposure are often asymptomatic. In light of the impacts on children and the nature of the health effects, EPA’s goal is to eliminate exposure to harmful levels of lead." They get it, right?
Uh-oh. The EPA veers away from the current script . . . .
"First and foremost, the Agency faces the difficulty of determining the level at which to set the standards given the uncertainties in information on cause and effect--what environmental levels in which specific medium may actually cause particular blood lead levels that are associated with adverse health effects. The Agency has tools, which are only generally consistent, that show that certain increases in environmental lead levels are associated with certain increases in blood lead levels. Given the range of uncertainty shown in its analysis supporting the establishment of a hazard level under this rule, EPA has developed a technical analysis that considers hazard standards for dust and soil at the lowest levels at which the analysis shows that across-the-board abatement on a national level could be justified. EPA recognizes, however that for any levels of lead in dust or soil judgment must be exercised as to how to treat the medium, and interim controls as well as abatement could be effective." [Emphasis added]
Sounding like administrators from another planet, the EPA continues:
"In performing its analyses for this rule, the Agency could not quantitatively compare interim control strategies with abatement strategies because there are only limited data available on the effectiveness of interim controls over extended periods of time, and those data which are available are not suitable for quantitative comparisons with abatements. In comparing interim control strategies with abatement strategies, one must make a number of assumptions
concerning the costs of administrative management, and frequency of monitoring and renewal over the planning horizon. For the 50–year planning horizon which the Agency used in its dust and soil analyses, one would have to compare the time stream of interim control expenses, for as long as such expenses are necessary, and weigh the possible differences in potential blood-lead reductions, to make a fair comparison of abatement and interim control strategies." [Emphasis added]
Later, the EPA warns: "Also, identification of lead-based paint hazards under this regulation is sure to have impacts that could be expensive even though the range of expenses is, itself, difficult to resolve because of the uncertainty of individual behavior and the willingness of individuals to accept risks that EPA may identify. Thus, if EPA were to choose standards that are too low, the public could be unable to distinguish between trivial risks at the low levels of lead from the more serious risks at higher levels. This could result in clean up for little to no health benefit, or conversely, it could result in almost no clean up because persons would question the credibility of the ‘hazard' determination." [Emphasis added]
Clearly the EPA just does not get around very much. Damn the expense, man, there is NO safe level of lead!!!
Importantly, the EPA seems to grasp the difference between CORRELATION and CAUSATION. I wish Congress understood that idea a bit better. . . .
"For dust and soil, EPA had substantial raw data on environmental levels and blood lead levels, even though it faced substantial uncertainty in correlating the levels. . . . If EPA were to set unreasonable standards (e.g., standards that would recommend removal of all lead from paint, dust, and soil), States and Tribes may choose to opt out of the Title X lead program and property owners may choose to ignore EPA’s advice, believing it lacks credibility and practical value. Consequently, EPA needed to develop standards that would protect children without wasting resources by chasing risks of negligible importance and that would be accepted as reasonable by States, Tribes, local governments, and property owners."
Hope you weren't eating while you read that last bit. Sorry!
I could quote from this document all day. In light of the nightmare that is the CPSIA, the EPA rules read like some sort of comedy routine. Unfortunately, the joke is on us.
So what did the EPA actually do?
"As stated in Unit II.F.3., today’s rule establishes two hazard standards for bare residential soil; 400 ppm for play areas and an average of 1,200 ppm for the rest of the yard. [See 40 CFR §745.65(c)] EPA recommends that organizations and individuals consider some action in certain areas even where levels in bare soils are below the hazard standard, particularly, if there is a concern that children 6 years and under might spend substantial time in such areas, or if there is concern that the bare soil in such areas may contribute to lead levels in the dwelling, or in the play areas. However, this rule does not mandate that any action be implemented when levels are found to be below the lead hazard standard. Moreover, the kind of response that organizations and individuals might consider could include modest actions such as planting grass (or other ground cover) to more extensive actions such as covering the bare soil with several inches of clean fill."
Yes, you read that correctly. The standard for play yards (sand) is 400 ppm lead and for bare soil is 1200 ppm lead. If we put a bag of dirt in a child's science toy, the current CPSC limit is 300 ppm and at this very moment, the Commission is mulling a reduction of the lead limit in that soil to 100 ppm. This change will make more science products either illegal or unsalable for children under 13 years of age. We don't believe lead labels solve the problem.
The CPSC's rule on our products will have no effect on play yards, bare soil or anything except items defined as "Children's Products" under the incomprehensible rule adopted by the Commission.
The longer this goes on, the more I am convinced that only a new government solves the problem. Sad . . . but true.
Friday, March 4, 2011
CPSIA - Our Worst Nightmare: A Recall Involving Spiders!
Needless to say, it is only a matter of time before Rep. Henry Waxman calls for hearings to interrogate Mazda management. Did they check the electronics? No, Mazda blamed the drivers for the spiders. . . . And what if Senator Dick Durbin reads about these spiders in the Chicago Tribune over breakfast? I can see another letter coming. And who will Dick Durbin write? The current Administrator of NHTSA is David Strickland, formerly the senior Senate staffer largely responsible for the Senate's role for creating our beloved CPSIA. Check out Rep. John Dingell's "gushing" remarks about the contribution of the Senate to that great legislative achievement. Durbin and Strickland, that "A Team" will get it done for the American public!
Spiders, cars and lead paint. It's a consumer advocate's worst nightmare. This requires a LEGISLATIVE SOLUTION, guys!
Sunday, February 27, 2011
CPSIA - My Testimony at the CPSC Hearing on 100 ppm Lead Standard 2-16-11
I have already published the links from the morning session. Viewing those clips before watching these clips may help you understand the flow of the argument better.
My full testimony:
[Notably, Ms. Tenenbaum cut me a break and let me go over my 10 minute allotment. I appreciate that courtesy.]
Commissioner Bob Adler questions me on the future of small business under the CPSIA and the need for the Commission to "follow the law" and implement the new standard despite the known consequences. This may be the most interesting interchange on the troubling issues under the CPSIA that I have participated in over the past four years. Check it out!
Commissioner Anne Northup asks about the ability of small business to obtain exemptions from the lead standard:
Commissioner Nancy Nord questions me about recycled materials, the cost implications of the new standards and injuries:
My call for a Five Year Stay on the new lead standard to allow for development of real injury statistics:
Monday, November 22, 2010
CPSIA - Certainty, CPSIA-style
And three years later, they'll hit you with a big penalty.
This week's crisis is the "discovery" by the Associated Press that some enamels used on glassware (the outside) have lead or cadmium bound in. The recall fo 12 million acknowledged safe Shrek glasses was the first indicator that we faced a "crisis".
Heavy metal use in glassware enamel is not exactly big news, nor a particular cause for concern (except for enterprising and paranoid reporters). Consider for example that our ever-wise Congress EXEMPTED these coatings years ago from lead regulation ("[The lead paint ban] does not include printing inks or those materials which actually become a part of the substrate, such as the pigment in a plastic article, or those materials which are actually bonded to the substrate, such as by electroplating or ceramic glazing." 16 CFR 1303.2(b)(1)). [You may also be interested to see all the other exemptions to the lead paint ban, in 16 CFR 1303.3.]
When confronted with the "shocking" news that other coated glasses besides Shrek had lead or cadmium in the enamels, the CPSC withered. They caved, and labeled these glasses (all very likely safe but featuring Super Hero images and the like) as "Children's Products". Here's a video of the reporter enjoying his 15 minutes of fame playing off the Shrek scare. He concedes that even HE thinks the risk is "low". No matter, it's good to stir up the mud. AP needs all the coverage it can get these days.
I am so happy we are being ruled by junk scientists now.
And the CPSC's determination that these products are "Children's Products" means they are subject to CPSIA regulation. This empowers the agency to recall them "out of an abundance of caution" and to impose penalties for failures to comply with the myriad rules of the CPSIA. No matter that this classification was hardly clear previously. Hmmm. Let's see how the mishmash interpretative rule on "Children's Products" makes this determination "clear".
I say "mishmash" because I defy you to figure this out for yourself by reading all the pages they threw at us. In fact, the latest "interpretation" in the so-called Final Rule does NOT seem to override the interpretive dicta in the prior version. It merely comments on the public comments that the agency by-and-large utterly ignored. The CPSC never bothers to reissue or conform past rules or interpretations. That's a job for us hobbyists.
In any event, it so happens that I addressed this very issue in my comment letter on the rule. The following section comes from the never-overwritten text accompanying the prior version of the rule. Consider this advice given to industry:
"The more of these types of characteristics that a product has, the greater the likelihood that the product is a children’s product. For example, a pen which is decorated or whose advertising and marketing features themes that correspond to obvious children’s interests, e.g., preschool characters, will greatly influence the purchase for preschool children. 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."
Clear as mud.
Remember, we in industry must interpret this gobbledygook and run our businesses. Perhaps even more difficult is to use "rules" like this in agreement with your dealers. Basically, since the rules make no sense, it is not possible to agree with many or sometimes ANY of your customers. Welcome to my world.
It is extremely unfortunate that in the wake of conceding the safety of the Shrek glassware, and even worse, in the face of explicit exemptions of glazings in the FHSA, the CPSC would proceed to declare these items within the scope of its regulations, thus exposing yet another group of innocent companies to huge unexpected and unjustified losses. Brands will be further damaged, consumer confidence dented, and no doubt, sales of children's products will be bruised in the prime selling season. Good going, government!
This agency seems downright dense about the impact of its activities. For myself, this act proves that the CPSC cannot be trusted, has lost any sense of what constitutes safe or unsafe, and is dangerously reactive (especially in response to members of Congress and members of the press). For regulated companies, this is the worst of times - we face a looney regulator who is absolutely devoid of self-discipline or judgment. They administer a kind of "hang-'em-high" justice. If you are ever in the gray area with the CPSC, you can count on them to push you over the edge. Their rationale - you have to err on the side of safety even if you have no reasonable basis to suspect that any safety issues existed.
Okay, I get it. But when the regulator has no idea where "safety" is, erring on the side of safety means pleasing reporters who are trying to sell papers. Reporters sell fear - that's the only way to sell papers these days. Connect the dots - random losses are coming to all of us.
Selling children's products is for crazy people. I cannot believe the damage being inflicted by these people.
The database gets approved tomorrow. Enjoy the ride!
Tuesday, October 12, 2010
CPSIA - WSJ Radio Interview of RW re CPSIA
The WSJ today released a radio interview in which I discussed my opposition to the CPSIA and my recent political awakenings. I hope you will give it a listen: Click HERE.
[PLEASE NOTE - if you have trouble opening this mp3 file, you can "right click" on the link and save it to your hard drive. You will easily be able to open from there.]
Monday, October 11, 2010
CPSIA - Schylling Penalty Update
You may recall that I expressed outrage over the mega penalty imposed on Schylling Associates earlier this year (see my posts on February 6, June 8, June 9, and June 10). There were many troubling aspects to this penalty, such as an expired statute of limitations and its arbitrary and massive size. This penalty was quite scary, especially in light of Bob Adler's remark at the March 3rd Commission meeting: "I personally wouldn't want to tie our hands by saying that the only time we can hit you with a big civil penalty is when there was a death or a serious injury. There may be an immense potential for death and serious injury which just through fortuity did not occur." There were no injuries in this case. No one has clarified the "immense potential for death and serious injury" in this ordinary and minor lead-in-paint case.
When you read on, don't forget - you could be next.
I submitted a FOIA request for documents relating to this penalty on June 9th.
Four months later, I received a very partial disclosure of documents from Schylling. The CPSC has not disclosed anything to me directly yet - they routed documents to Schylling who routed them to me, redacted for confidential financial information.
I don’t intend to belabor the inadequacy of the CPSC's disclosure right now, except to note that failure to provide full disclosure is against the explicit policy of the agency. Not that policy or the law matters at the CPSC these days if they want to do something else. It’s great to be King, ain’t it? My original FOIA filing included this paragraph:
“In making this request, I note the following statement in 16 CFR §1015(b): ‘The Commission's policy with respect to requests for records is that disclosure is the rule and withholding is the exception. All records not exempt from disclosure will be made available. Moreover, records which may be exempted from disclosure will be made available as a matter of discretion when disclosure is not prohibited by law or is not against the public interest.’”
Enough whining. I will pursue the missing documents with the CPSC but for now, want to give you a clue on how penalties are being imposed by this agency. Quick summary: my original blogposts above were pretty accurate (we're all screwed).
I was given four documents that were not previously available publicly:
1. Letter of March 5, 2010 to CPSC from Patton Boggs LLP, counsel to Schylling.
2. Letter of March 5, 2010 to Patton Boggs from Cheryl Falvey, General Counsel, CPSC
3. Letter of April 21, 2010 to CPSC from Shook, Hardy & Bacon LLP, counsel to Schylling (missing attachments, see below)
4. Email exchange between Trial Attorney, Office of Compliance and Patton Boggs, counsel to Schylling, from September 4-9, 2009.
Schylling also provided me with the letter dated August 10, 2009 from late Senator Ted Kennedy to the Commission protesting the original suggested penalty of $600,000. The penalty was later to reduced to $200,000, approved, rescinded and then doubled to $400,000 by an angry Commission. [Why they got so angry remains a mystery, but their anger oddly is only tangentially related to this discussion today. All permutations of the penalty were unreasonable - before, during and after the Commission got angry.] Finally, Schylling also provided me with missing attachments from the April 21 letter – hate mail they received.
Here’s what I learned about this penalty:
a. There are few apparent constraints on the CPSC when it comes to arbitrary penalty assessment. That's how Schylling got zinged for $400K and probably explains how Daiso got whacked for $2.05 million.
The big issue confronting the CPSC in deciding on this penalty appears to be the profitability of the company and whether the owners collected too much money from the company. It is worth noting that the CPSC chose to weigh in on owners' salaries and bonuses and ALSO on whether the company DISTRIBUTED too much money to the owners. Cash distributions from a S Corp is a RETURN OF CAPITAL - in other words, that cash is the property of the owners. They are legally free to remove it without corporate law or tax implications (as long as the distribution doesn't bankrupt the company, not an issue in this case).
Do you think it is any business of this federal agency whether YOU take YOUR money out of YOUR company? Apparently it is the CPSC's concern and equally, they assert that they can approve or disapprove such transfers after the fact.
Is there a law somewhere that gives them this power?
There is no evidence in the papers that the CPSC weighed ANY mitigating factors, including the lack of injuries.
The CPSC requested the following documents to assess their penalty:
- Federal tax returns for one entity from 2005-2009 and for another entity for 2008-2009
- Federal tax returns for the three family members employed as executives at the company for 2007-2009.
- Federal tax returns for a family trust over 2007-2009 plus financial statements for such entity.
- Information about ownership structure, all affiliated entities with "explanations as to how each relates to [the others]".
- Consolidating and individual financial statements for each entity for full year 2009 (this request is not entirely clear, but this is my interpretation of what the CPSC requested).
Hmmm.
The March 5th Patton Boggs letter states "When you informed me on February 24 that the Commission had rescinded its provisional approval of the Schylling settlement, you indicated that there was concern that Schylling had misled the Commission regarding the financials, and/or had made exorbitant payments to its owners. Any such allegation is false."
I find this dialogue chilling. Please consider that the CPSC might have been talking about YOU. And might be talking about you soon.
The Patton Boggs letter pleads "Submitted herewith [is] a chart showing the annual salaries and distributions of the three owners of this S-Corp, 2007-2009 . . . . As this shows, the compensation paid to the owners is well within the reasonableness zone for companies of Schylling's size" and continues "salaries paid to the three owners are reasonable and have not increased - except for modest cost of living adjustments - over the past 4 years." [Emphasis added]
Intrusive? Over-reaching? Humiliating? Ready to do this yourself when the time comes???
Does this agency have too much power? What do you think, Commissar?
[Btw, the fact that the company's testing budget ballooned from $144K in 2006 to $645K in 2009 didn't save them. It was noted in the letter, but the Commission still whacked them with the $400K penalty.]
In the April 21 Shook Hardy letter, counsel to Schylling makes even clearer what was going on here: "The inference appears to be that Schylling could have afforded to pay a higher civil penalty had its principals not taken excessive compensation or that Schylling and its principals attempted to hide the assets of the business prior to action by the CPSC. This view does not reflect the facts."
To judge by these letters, the agency's goal was to hit Schylling as hard as possible without killing it, and so the debate turned to whether Schylling could withstand the blow. The agency questioned owner compensation because Schylling's disclosure might frustrate the plan to hit them with an epic penalty. To defend the mega penalty, the CPSC actually needed to prove that Schylling was playing games with its disclosure, something their lawyers hotly contested. The issue of safety is lost in the hunt for retribution. How far the CPSC has fallen . . . .
My mind wanders . . . might this CPSC also want a big headline? Hold that thought for a little while.
Don't forget, NO ONE was hurt by the products Schylling recalled. The recalls were YEARS OLD by the time the CPSC decided to make an example of Schylling, arguably past the statute of limitations (for those of you who are small-minded enough to care about the Rule of Law). The company's conduct, good or bad, seems irrelevant to the discussion in these pages.
Can you imagine what it would like to defend yourself against this kind of foe? How can you protect yourself against a vengeful government agency unconstrained by checks-and-balances? I can tell you - Schylling was scared "witless". They had no practical ability to litigate, despite the injustice of this excessive and unfair penalty. In the face of undocumented government threats, the ugly reputation of this agency's tactics whispered among practitioners these days, who would face them down? Bet the company - good idea until it's your company.
Let me know when you figure out what you would do.
b. Schylling's ancillary losses or penalties were substantial. The CPSC was also not accountable for its torts or mistakes. Buyer beware!
Can you trust the CPSC today? I think one can form a better opinion of the trustworthiness of this federal agency after reading the Schylling case documents.
Here are a few additional Schylling punishments and penalties noted in the papers:
- They were forced to withdraw from an important acquisition in May 2009 when threatened with a $600,000 cash penalty (which was later cut by two-thirds).
- They incurred massive legal bills, not to mention costs relating to the recalls.
- The highly-publicized remarks of a CPSC spokesman to the Chicago Tribune in which he discussed the "diminished financial condition" of Schylling led to problems with Schylling's lender. This comment to the press violated the confidentiality of discussions between Schylling and the CPSC - but I guess confidentiality that doesn't apply when the Chicago Tribune calls. I am not aware of any apology from the CPSC about this flagrant violation of trust.
The adverse publicity which resulted from the recall, and fed by a publicity-hungry agency desperate to appease the media and Congressional overlords, led to hate mail like this:
"Being Untruthful about lead in paint has cost you our business. We will tell everyone we know that none of your products can be trusted. This will be painful for your bottom dollar sales. The lack of leadership in your company and caring about the bottom dollars is evident. We hope your made in China policy is worth it!"
and
"Actually, This isn't about the RECENT recall, this is about the SNOW JOB recall you never reported. You people are REAL pieces of sh*t, I lived up there when you distributed these toys, you're about to have you ASS sued off. In case you forgot, I'll help you remember that you are MORTAL ! Maybe you need someone to bring some lead into your life you piece of sh*t. I hope you make the right choice as to just what to do with yourself. Technically, this isn't the same damn email XXX got. btw, you people soon enough won't even BE in the toy business."
[Emphasis added]
Do you get mail like this? What do you think about a federal agency engaging in conduct that produces this kind of extreme response . . . for what is essentially a dispute about administrative procedures involving a no-injury recall of a small number of toys several years ago? Did I mention that there is no way to bring this agency to account? Remorseless pursuit of scary headlines leading to threats of violence against toymakers - I guess this is that famous "change you can believe in".
Yes, we can.
Senator Kennedy noted that the penalty was "disproportionate to penalties recently assessed against other substantially larger companies for the same type of violations." Arbitrary and capricious, perhaps? Kennedy provides DATA to back up his assertion, noting CPSC penalties against Family Dollar Stores, Hobby Lobby Stores, First Learning Company, Ltd., Michaels Stores, A&A Global Industries, Raymond Geddes & Co., Downeast Concepts and Mattel (oh, Mattel . . . ) - ranging between 0.001% and 0.316% of sales. The proposed penalty on Schylling - 2% of sales, ultimately reduced to 1.33% of sales.This letter may be the reason Anne Northup revoked her vote in favor of the $200,000 penalty., even though Kennedy's letter proceeded the decision by almost six months and referred to a penalty THREE TIMES the size presented to the Commission.
Have you done the math in your head about what you would be paying if the CPSC got pissed off at you? Do you have a fund set up to finance this kind of setback? Hmmm.
It's a shame that our legal system provides no way for a company to defend itself against government gone MAD without taking fantastic financial, regulatory or business risks. I fondly remember the days when we had a working legal system in this country and when decisions were subject to review, you know before government power was expanded so dramatically and individual rights were extinguished.
I know, I know, we have to protect the CHILDREN! That makes everything okay. The agency can do no wrong. . . .
I remember those days fondly. I will be thinking of them on November 2nd, too.
In the meantime, I will see if I can get the CPSC to cough up a few more documents for the public to see. They have a policy on this, you know . . . .
