Wednesday, December 29, 2010
Gib Mullan has had a long and illustrious career at the CPSC. Formerly a litigation partner at Kirkland & Ellis, Gib joined the CPSC as its General Counsel in 2004 and later became the Director of Compliance and Field Operations. In that latter role, Gib drew some fire in this space. Later, in something of a palace coup, he was "detailed" to the CPSC's Office of Executive Director and then "assigned" to a "special project" at Customs and Border Patrol. The Product Safety Letter questioned whether this was a legal maneuver by Chairman Tenenbaum as it was not accompanied by a Commission vote. In other words, PSL implied that Mullan was the subject of an illegal firing by Tenenbaum.
Hmmm. And now ex-Kirkland partner Mullan is Chief Counsel for the House Subcommittee responsible for the CPSC? And working for the Republicans?
Can you say "oversight"?
Sounds like fun!
It is worth noting that this meeting will be held in broad daylight with both sides at the same table. It appears that the Republicans are making a statement about changes in legislative process as well as changes in law. I think it's high time that the legislative process emerge from the shadows and commend them for their approach.
It is also quite noteworthy that this meeting will take place on the FIRST day of the new Congress. The swearing-in ceremonies will take place on Jan. 5th in the afternoon. The next day the Energy and Commerce committee staff begin work on the CPSIA. You have to be impressed at the speed and seriousness that the Republicans are attempting to address this issue. Who says our government is broken?
The politics in Washington changed a lot at the midterm elections. Not only has the House changed hands, so the Waxman era ended, but elsewhere things are changing, too. In the Senate, perhaps a dozen Democratic Senators are facing reelection in this cycle and the Tea Party is still a major force. What will the likes of Mark Pryor think about their chances when their compadres (like Blanche Lincoln) have been so recently vanquished? Perhaps that will motivate a shift in approach. Will the Senate stiffen if a Republican House sends in a fair amendment of the CPSIA? The winds may finally be at our backs.
And then there's the White House. It's anybody's guess what's going on there, but there is reason to believe Mr. Obama is tacking toward the center. This is Clintonesque, a la 1994, and may be a trend that holds up. He has some tough choices to make, but the center may be a better place for him now. That suggests a greater willingness to cooperate with a bipartisan retooling of this law.
If Obama hugs the center line and if the Senate is feeling less unrelentingly liberal facing reelection in the Tea Party era, a serious amendment of this law is possible. It is even possible that these wave lengths will penetrate the CSPC Commission and all sorts of behaviors could change. O to dream . . . .
And we need the help, guys. The 15 Month Rule is a crisis waiting to happen, the testing and certification stay is due to expire on February 10 (in the middle of the Chinese New Year) and of course, there's the 100 ppm lead standard looming in August. There's a lot to address. Let's hope this can move along quickly and put an end to this sorry chapter in our regulatory history.
Wednesday, December 22, 2010
You have to chuckle at the "15 Months" part. This rule was legally mandated to be enacted 15 months after the CPSIA was signed into law. The presumed date of enactment would then have been November 14, 2009, a mere 14 months ago now. They didn't even published a first draft until May 2010. If the agency can somehow finish this project by January 14, it could be called the "15 Months Times Two" Rule. Then again, it's basically inconceivable that they will make it. Eventually they'll need another name for this thing.
The urgency behind finishing up this rule is that the testing and certification stay expires on February 10, 2011. Remember that Bob Adler already said he wouldn't vote an extension of this stay because . . . he hates stays. Perhaps he prefers market chaos and economic depression instead. Anyhow, to avoid the showdown, they need to get their ducks in a row, hence the need to get this rule going.
I sent in comments on the first draft of this rule on August 3. I wasn't a big fan . . . and I guess other people had reservations, too. According to www.regulations.gov, the CPSC received 112 comments letters (that may overstate the number, because regulations.gov seems to have some duplicates). I haven't read them myself, but I assume I am the only one who saw any flaws in this rule. The rest of the letters are probably just "thank you" notes.
Anyhow, it's worth noting that the Chinese New Year occurs on February 3, 2011 so take my word for it, all the Chinese factories will be closed on Feb. 3rd and probably won't reopen until Feb. 10 at the earliest after a two-week holiday. Some workers are gone three or even four weeks for this holiday. In a "best case" scenario, the CPSC can't take action on this rule until they officially acknowledge the public comment "thank you" notes and hold a public Commission meeting. Do the math - if they choose to take action on this rule now, we will get about ten minutes notice to begin conforming. I can't see any risk of market chaos again . . . can you?
Here's a fairly obvious fact for you - we have not incorporated any of the pending rules into our supply chain or manufacturing processes. Why? You tell me what I'm supposed to do. The rule that has been published is deeply flawed and, basically, stupid. It is not a final rule. 112 comment letters were filed on it. It could change . . . it BETTER change. How am I supposed to implement rules that haven't been published or possibly even written? Telepathy? I don't read minds and I haven't implemented the unknowable, either.
If this does not make your blood boil enough, consider these excerpts from the notice of Final Rule Stage:
- "The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of death and injury associated with consumer products." [Emphasis added] The CPSIA makes consideration of RISK by the CPSC illegal. Bummer, huh? Someone should have told the CPSC because they still claim to be concerned with "risk" of injury.
- "When deciding which of these approaches to take in any specific case, the Commission gathers and analyzes the best available data about the nature and extent of the risk presented by the product." And then ignores it??? See also the final bullet below.
- "As for exemptions [from the "15 Month Rule"], the statute does not appear to give the Commission the authority to exempt firms from the testing or certification requirements, so it may not be possible to exempt firms within section 14 of the CPSA." In other words, HTA, you can lump it. And the CPSC is telling you who to blame - Congress.
- "The congressional mandate to issue this regulation does not require the Consumer Product Safety Commission to do a cost/benefit analysis for this regulation. Therefore, a cost/benefit analysis is not available for this regulatory action." Head-in-sand syndrome. I bet you'll be able to do a cost/benefit analysis pretty quickly when your costs go up again by 20x.
- "[It] is not possible to provide an analysis of the magnitude of the risk this regulatory action addresses." Ahem. And it's okay to put forward a rule of this complexity and far-reaching impact while flying entirely blind because . . . why???
Let's not forget that there's a new Congress being sworn in January 5th. The incoming Republican House majority has pledged to shrink the federal government and to closely examine how regulatory agencies are governing. Hmmm. Help may be on the way . . . soon.
Tuesday, December 14, 2010
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.
Tuesday, December 7, 2010
a. "No one knows how much lead people absorb from holiday decorations, says pediatrician Bruce Lanphear, of Canada's Simon Fraser University." And if he said it, it must be true. [Of course, pediatrician Philip Landrigan, of Mount Sinai School of Medicine in New York, notes "In the whole scheme of things, is it a huge risk? No."]
What's the problem with Xmas lights, you say? Lead in the PVC. According to Alicia Voorhiess, a mom with a blog, manufacturers "use it" in the PVC. Right - you got us! Don't worry, though, after much digging, she found two companies that offer Xmas lights which comply with Restriction of Hazardous Substances (RoHS), a European standard which limits the presence of lead in lights.
Ummm, Alicia, RoHS is a standard to designed to prevent leaching of heavy metals to protect the environment and only applies to electronics. This MEANS that the lead is restricted in the bulbs and fittings, not the PVC. Whatever, it sounds safer, doesn't it?
The author of the article quotes Dr. Alan Greene (my college classmate) saying that you should handle your Xmas lights with gloves. Why stop there? Moon suits, anyone?
b. Artificial Christmas trees are made of PVC, too, and we know what manufacturers are wont to do with PVC. The solution - use a real tree grown without pesticides.
I find this a most uncreative solution, myself. Here's a few more:
- Post a picture of a beautiful tree near the spot you might have placed your tree. Keep it away from the fire, however.
- Consider just displaying your Xmas lights in their packaging. No touching!
- Use an artificial tree, but place under a glass enclosure or something air tight like Saran Wrap. Stand at least five feet away at all times.
All of these remedies will protect you from lead. That said, please remember there is NO safe level for lead. And a holy, jolly Christmas to you, too!
Shame that USA Today didn't focus in on the fact that there is lead in the air, in our water and in our food. OOPSIE! In fact, lead in water is conveniently piped into Washington, D.C. homes for kids to drink in their own bathrooms and kitchens. Nice! Somehow USA Today missed this. Shocking . . . .
c. Candles with metal wicks might also have lead in them, or then again, maybe they won't. In a blow to poorly-researched newspaper articles, the CPSC apparently banned these wicks in 2003. Who knew the CPSC actually tried to its job before the CPSIA? Somebody should have told Congress.
According to this all-knowing newspaper, candles also contain paraffin, a wax made from petroleum. Not sure why I should care about that, but it sounds ominous. And some fragrances in candles have phthalates in them "which can affect the hormonal system". Isn't knowing nothing about science FUN???
The solution - The author of this article actually recommends that you use pure beeswax candles. Happy hunting! They also suggest you "poke cloves into oranges". Ah, the old clove poking trick! That sounds like fun but IS IT SAFE? This article says oranges have lead in them. NO! And, for an extra kicker, it also says they have cadmium, too: "If the soils contain toxic metals like lead, mercury and cadmium then the consumers may be poisoned as happened in the "Ouchi-ouchi" disease in Japan . . . and similar episodes." Wow, Ouchi-Ouchi! Scott Wolfson, do you hear a bell ringing? [Eating oranges didn't cause "Ouchi-Ouchi" but then again, researching these things is sooooo time-consuming.]
So there you go. Skip Christmas this year, too dangerous. I wonder if a Festivus pole is lead-free . . . .
Hope springs eternal. Help may finally be on the way!
Wednesday, December 1, 2010
And one year later - they are showing troubling signs of declining IQ points, a possible sign of lead poisoning! In a stunning turn of events, Canada apparently has decided to play one-upsmanship with the United States. Not satisfied at losing in the international arena of regulatory lunacy, Canada proceeded to tighten up our oh-so-loose CPSIA lead standards.
Editorial Pause Here - Someday I want to see governments everywhere refer to INJURY STATISTICS when they call for new laws to make people safer. To figure out if people are "unsafe", one must certainly know if they are being injured . . . right? You'd really want to be able to measure that, wouldn't you? Please tell me you understand this point . . . . Soooo, if one chooses to argue that we are harming children with "too much" lead in children's products, isn't incumbent on the accuser to demonstrate in some meaningful way that the harm we will spend zillions to "eliminate" actually exists, you know, at a bare minimum? Shouldn't we demand a higher standard of justification than "it stands to reason"?
Back to Canada - Canada announced on November 29th "the most stringent rules in the world" on lead. The Canadians have decided that lead limits should be 90 ppm for toys and any product other than a kitchen utensil intended to come in contact with the mouth for children three years old and under. They will also join us at 90 ppm for lead-in-paint.
Please recall that the dirt in Mr. Obama's backyard tested for lead at higher levels than 90 ppm. His DIRT. So now we know he won't be able make toys or teething rings out of his dirt and sell those products in Canada. Finally, the menace is contained!
So why did they do this? "Health Canada says the new limits are needed because while reputable companies do their best to ensure lead has not been added intentionally to their products, companies can still run into trouble with quality control when importing huge volumes of goods in complex supply chains."
Oh, I see - it's the fault of darkest China! Good Canadians wouldn't do this but those evil people in their complex supply chains - they can't be trusted.
I would toss this off as some kind of joke other than the fact that this creates a massive business problem for us. And, of course, after the cynical and ignorant politicians get past congratulating themselves on saving the populace (from what?), there will be great mystery about what happened to variety of playthings in Canada or why educational products are much harder to find. What a mystery that will be!
As an American supplier of many Canadian school supply dealers and Canadian schools (we make Canada-specific educational products), I want to note that we have never had a single accusation of injury in Canada from any of our products since we were founded in 1984. I do not relish attempting to meet this asinine standard, lower than the loathsome U.S. standard of 100 ppm due to come into being in August for no particular reason other than to kill jobs. Will anyone feel sorry for me when we get our first test report showing lead levels of 93 ppm on a single part in an assembled toy? In other words, compliant with the U.S., but 3 parts-per-million above the arbitrary trace standards of Canada? Nah, it will be ours to savor - no one will care. We have to make children safe, safe, safe and who could put a price of the safety of our children?!
I don't know how long we will sell products for kids under three in Canada if this law goes forward. Perhaps the Canadians figure the kids can start to be educated after three.
Maybe Canada really has a chance to out-stupid us if they keep this up. Bully for you, Canada! And I thought it couldn't be done . . . .
I have submitted the following written testimony. I will not be testifying at this hearing.
STATEMENT OF RICHARD M. WOLDENBERG
Chairman, Learning Resources, Inc.
Vernon Hills, Illinois
As an operator of a small business making educational products and educational toys, I have had a front row seat for the implementation of the Consumer Product Safety Improvement Act of 2008 (CPSIA) by the Consumer Product Safety Commission (CPSC). On the occasion of your CPSC oversight hearing, I want to highlight the economic damage wrought by the CPSIA without achieving any material improvement in safety statistics. I also want to bring to your attention the open hostility of the CPSC toward the corporate community in the implementation and enforcement of the CPSIA, and conclude with my recommendations for legal reforms to restore common sense to safety administration without reducing children’s safety.
The consequences of the change in the consumer safety laws to a precautionary posture has had notable negative impacts and promises to create further problems, namely:
An equally frustrating bureaucracy has sprung up around recordkeeping under this law. Burdensome requirements spawned by the government’s new involvement in our quality control processes forced us to make large new investments in information technology with no return on our investment. In addition, the pending CPSC draft policy on component testing promises to convert the simple task of obtaining a complete suite of safety test reports into a major recordkeeping chore. We will now be forced to manage each component separately, tracking test reports on each component one-by-one. This promises to multiply our recordkeeping responsibilities – and the related risk of liability for failing to comply – by more than an order of magnitude.
d. Crippled by Regulatory Complexity. Our problems don’t end with testing costs or increased staffing. We are being crippled by regulatory complexity. Almost 28 months after passage of the CPSIA, we still don’t have a comprehensive set of regulations. Please consider how mindboggling the rules have become. There were fewer than 200 pages of safety law and CPSC rules that pertained to our business until 2008. These rules clearly defined our responsibilities and could be taught to our staff (in fact, many were rarely applicable to us). Today, the applicable laws, rules and interpretative documents exceed 3,000 pages. As a practical matter, it is simply not possible to master all of these documents – and yet it’s potentially a felony to break any of these rules. Sadly for us, the rules and CPSC staff commentary keep changing, are still being written and are rarely if ever conformed. How can we master and re-master these rules and teach them to our staff while still doing the full-time job of running our business? Ironically, the recalls of 2007 and 2008 were never a “rules” problem – those famous recalls were clearly a compliance problem. Imagine what will happen now with an unmanageable fifteen-fold increase in rules. No small business “ombudsman” can make that problem go away.
e. Small Business Will Certainly Suffer. The CPSIA was written in response to failings of big companies, but hammers small and medium-sized companies with particular vengeance. Our small business has already lost customers for our entire category on the grounds that selling toys is too confusing or too much of a “hassle”. This is our new reality. The highly-technical rules and requirements are beyond the capability of all but the most highly-trained quality managers or lawyers to comprehend. Small businesses simply don’t have the skills, resources or business scale to manage compliance with the CPSIA. For this reason, small businesses bear the greatest risk of liability under the law, despite being responsible for almost no injuries from lead in the last decade. The double whammy of massive new regulatory obligations and the prospect of devastating liability are driving small businesses out of our market.
4. Unjustified Hostile Rulemakings. The CPSC has implemented rules governing the public database that adversely affect the Constitutionally-guaranteed due process rights of our businesses. There is no adequate public policy justification for the erosion of the remarkable civil rights that distinguish the American legal system among all international legal systems – yet the Commission voted 3-2 to allow falsehoods to be posted without recourse in a database the CPSC will maintain. In other cases, the agency has published draft rules (yet to be acted on) which could force companies like ours to spend as much as $10,000 per item per year to meet ARBITRARY rules on testing frequency or “reasonable testing programs” – notwithstanding strong evidence that these rules are wasteful, unnecessary and financially irresponsible. The pendency of rules like this creates destabilizing market uncertainty and forces business decisions that have no basis other than fear of future regulation. For instance, Wal-Mart has already instituted a 100 ppm lead standard months ahead of the POSSIBLE implementation of the standard by the CPSC – simply because the CPSC has been so slow to act.
The CPSIA went off track by taking away the CPSC’s authority to assess risk. If the CPSC were again required to regulate based on risk, safety rules could focus on those few risks with the real potential to cause harm to children. All risks were not created equal.