CPSIA – Waxman’s New Amendment – Needed Changes

Here is my full list of needed changes to the CPSIA:

Needed Changes to the CPSIA That Will Guarantee Safety and Promote U.S. Jobs:

1. Restore the CPSC’s authority to base its safety decisions, resource allocation and rules on risk assessment by giving the Commission the discretion to set age and product definition criteria for 300 ppm lead standard and phthalate ban. Eliminate the 100 ppm lead standard.

2. Definition of “Children’s Product” should not include anything primarily sold into or intended for use in schools or which is used primarily under the supervision of adults. Other explicit exceptions: apparel, shoes, pens, ATVs, bicycles, rhinestones, books and other print materials, brass, connectors, others? This would take these items outside the law, including tracking labels.

3. The standards/bans for lead and phthalates should be prospective from February 10, 2009, allowing the sale of merchandise manufactured in compliance with law prior to the implementation of the law.

4. Lead-in-substrate and phthalate testing should be a “reasonable testing program”, not mandated outside testing. Leave 300 ppm standard in place, but place burden on manufacturer and supply chain for compliance activities. Phthalate testing requirements should explicitly exempt inaccessible components, metals, minerals, hard plastics, natural fibers and wood.

5. Eliminate required future reductions in the lead-in-paint standard levels if technologically-feasible. Clarify that all inks are excluded from the lead-in-paint ban. Eliminate the definition of “technologically feasible”. Eliminate the “periodic review” provisions that require ratcheting up of requirements (e.g., periodic review of F963 to achieve “highest levels of safety” that are “feasible”). Eliminate the whisteblower provision.

6. Definition of “Children’s Product” should be limited to children 6 years or younger and should eliminate the difficult to apply “common recognition” factor of Section 3(a)(2)(c) of the CPSA. Definition of “Toy” (for phthalates purposes) should be limited to children 3 years old or younger and should explicitly refer only to products in the form used in play.

7. Restore ASTM F963 to voluntary standard status. Eliminate CPSC certification of laboratories (rely on the market to provide good resources).

8. Add penalties (up to and including felonies) for false or misleading accusations of violations of law or safety violations.

9. Rewrite penalty provision on resale of used product such that violations are only subject to penalty if intentional (actual knowledge or reckless endangerment) and if the violation led to an actual injury. Eliminate the “knowing” standard with its imputed knowledge of a reasonable man exercising due care. Completely reformulate penalties to restrict them to egregious conduct (including patterns of violations), reckless endangerment or conduct resulting in serious injury.

10. Restore the ability to export non-compliant product as long as the product is compliant with the destination jurisdiction’s law.

11. Mandatory tracking labels should be explicitly restricted to cribs, bassinets, play pens, all long life “heirloom” products with a known history of injuring the most vulnerable children (babies). Tracking labels would be voluntary on all other children’s products and if in use, can be used to trim scale of recalls (as with other data maintained by businesses).

12. Public injury/incident database restricted to recalls only. Private, confidential database permitted for other injuries.

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CPSIA – Waxman’s New Amendment – Needed Changes

CPSIA – ICPHSO Update – Remarks of Mary Toro and Kris Hatlelid on Toxicity and Risk

Mary Toro is the head of the FHSA Enforcement Division.

• Reviewed regulatory scheme in a fair amount of detail.
• Incorporation of ASTM F963 brought into the law a solubility standard for heavy metals in surface coatings.

Remarks of Kris Hatlelid, Health Sciences:

• Wealth of data on cadmium is from worker exposure or inhalation. There is almost nothing out there about ingestion, including whether it is a carcinogen when ingested. Studies also need to consider life stages. Longer term studies are done on mature animals, which might not be relevant to children. The challenge from the data and its inadequacies are considerable.
• Among other things, Hatlelid noted the importance of dose-response evaluation. This reminds one of the old toxicologists’ saying that “the dose makes the poison.” She also mentioned exposure assessment and risk characterization. It is comforting to be reminded that CPSC scientists are still aware of these issues (I never had a doubt). How can we get the message to the junior scientists in Congress?

The notes on toxicity gives perspective on cadmium and the panic over jewelry. I hope someday the CPSC regains the upper hand on setting safety policy from the Associated Press.

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CPSIA – ICPHSO Update – Remarks of Mary Toro and Kris Hatlelid on Toxicity and Risk

CPSIA – What Constitutes "Safe"?

One of the tragedies of the CPSIA melodrama is that the consumer groups have completely hijacked the concept of safety, turning it utterly away from concepts of risk assessment. To what, you say? Away from management of identifiable risks to avoidance/elimination of perceived risks. In other words, Congress and our regulators now ignore the data on risk and focus instead on the possibility of risk. The POSSIBILITY of injury, not the actuality of injury.

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

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

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

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

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

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

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

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

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

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

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

Respect for Congress, that’s another thing.

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CPSIA – What Constitutes "Safe"?

CPSIA – The Eyes Glaze Over . . . .

Sometimes I wonder if they have completely lost it at the CPSC. This evening we received the CPSC Federal Register notice on the Stay decision (actually entitled “Consumer Product Safety Act: Notice of Commission Action on the Stay of Enforcement of Testing and Certification Requirements”). I seriously wonder if anyone read it over in Bethesda. I have NEVER seen anything this dense and unintelligible come out of that office.

As the Commission tucks itself into bed before an exciting day tomorrow in which it can either decently provide enough time for an orderly implementation of this mess of a law or send small businesses down the river, I hope somebody is thinking about the complexity of what they have wrought. Of course, rules always seem more complex when they apply to you than when they apply to someone else. Still, perhaps a quick scan of this document might enlighten the Democrat Commissioners who seem particularly dense on the subject of why businesses want more clarity before the rules go “hard”.

I uncovered this while on a mission from a reader of this space. I had been alerted to the possibility that this document said that the lead content stay was LIFTED. This could not be true, since a ballot vote is definitely docketed for tomorrow on this subject. Even at a Waxman-dominated CPSC, it would be rather ballsy to issue a notice announcing a decision before the vote was tallied. With three Democrats “highly sympathetic” and “seriously considering” the opposing views but by all appearances having irretrievably made up their minds, it is not hard to imagine that skipping a step might have a certain appeal. Why bother waiting for the Republicans to lose (again)???

Well, incredibly, my reader was RIGHT – the document states that the date for the lead content rules to become effective is August 10, 2010, a “date certain”:

“With regard to lead content, the Commission has determined that testing of children’s products for lead content by a third party conformity assessment body and certification based upon that testing should begin on products manufactured after August 10, 2010 to allow component testing to form the basis for certifications for lead content and permit the staff to complete an interpretative rule on the meaning of the term ‘children’s product.’ An interpretative rule on the meaning of the term ‘children’s product’ would provide firms with additional guidance on when testing for lead content will be required by the Commission.”

Apparently, no one updated this FR notice for this morning’s motion to docket this decision for ballot vote tomorrow. Oops!

Remember the part in the hearing today where they discussed market disruptions and the need for businesses to have time to absorb and adjust to the new rules? Does anyone wonder why we have confusion in the market after you read this document? Please be honest. Myself, I experience shortness of breath when I read dense prose like this. I think the works of David Hume seem more accessible than this kind of thing – so why does the Commission delude itself that anyone undersands the mountains of rules and rulings it spews out? Market confusion is all but certain when implementation is handled this insensitively.

One reason is that some Commissioners hear what they want to hear, and ignore the rest. This is called “selective hearing”; I know all about this topic, as there is at least one person who lives in my house who has been regularly accused of this malady. [No names, please.] For instance, yours truly pointed out serious errors in the presentations by CPSC professional staff during last week’s workshop as well as in the preceding December 2 hearing to a Commission staffer. I don’t blame the CPSC staff nor do I consider these errors to mean much . . . other than the fact that the CPSC staff is supposed to know these rules better than anyone else, and if they make errors (understandable), what do they honestly expect of the regulated community??? If we make these errors, we get whacked with high fines or possibly, if the CPSC is riled up enough, go to the pokey. Isn’t the occurrence of serious errors by CPSC staff an indication of over-complexity? This was all known to the Commission before today’s hearing. Get this – the Emperor has no clothes.

Still not convinced? Try this passage on for size, and then TRY to imagine running a normal business catering to children and in your spare time attempting to comply with this law. Imagine trying to master this law as implemented by the CPSC, given that you are not a lawyer, can’t afford a lawyer or a legal department, and don’t have a few unoccupied months to study the mountains of paper the CPSC emits. It’s something you have to do in between everything else you do in your job. And the CPSC says:

“In the months after the Commission issued the stay of enforcement, the regulatory environment has changed significantly [No problemo!], and both the CPSC and interested parties have increased their understanding of the CPSIA and its requirements. [Yes, bring it, baby!] For example, between February 9, 2009 and the date of publication of this notice, the Commission issued more than 20 FEDERAL REGISTER notices, statements of policy, guidance documents, proposed rules, interim final rules, and final rules pertaining to the CPSIA, and most of these documents pertained to testing and certification issues. [This is not a joke. I didn't write this part, either.] These FEDERAL REGISTER documents include:

• “Third Party Testing for Certain Children’s Products; Notice of Requirements for the Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity with the Limits on Total Lead in Children’s Products,” 74 FR 55820 (October 29, 2009);
• “Notice of Availability of a Statement of Policy: Testing and Certification of Lead Content in Children’s Products,” 74 FR 55820 (October 29, 2009);
• Proposed Rule on “Safety Standard for Infant Walkers,” 74 FR 45704 (September 3, 2009);
• Proposed Rule on “Safety Standard for Bath Seats,” 74 FR 45719 (September 3, 2009);
• “Third Party Testing for Certain Children’s Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity with Parts 1203,1510,1512, and/or 1513 and Section 1500.86(a)(7) and/or (a)(8) of Title 16, Code of Federal Regulations,” 74 FR 45428 (September 2,2009);
• Final Rule on “Children’s Products Containing Lead; Determinations Regarding Lead Content Limits on Certain Materials or Products,” 74 FR 43031 (Aug. 26, 2009);
• “Notice of Availability of a Statement of Policy: Testing of Component Parts With Respect to Section 108 of the Consumer Product Safety Improvement Act,” 74 FR 41400 (August 17,2009);
• Final Rule on “Children’s Products Containing Lead; Interpretative Rule on Inaccessible Component Parts,” 74 FR 39535 (August 7, 2009);
• Proposed Rule on Requirements for Consumer Registration of Durable Infant or Toddler Products, 74 FR 30983 (June 29, 2009);
• Final Rule on “Children’s Products Containing Lead; Final Rule; Procedures and Requirements for a Commission Determination of Exclusion,” 74 FR 10475 (Mar. 11,2009);
• Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108; Request for Comments and Information, 74 FR 8058 (Feb. 23, 2009); and
• Interim Final Rule on “Children’s Products Containing Lead; Exemptions for Certain Electronic Devices; Interim Final Rule,” 74 FR 6990 (Feb. 12, 2009).

Additionally, the Commission has met with numerous parties to discuss various aspects of the CPSIA or educate interested parties about the CPSIA’s requirements, and, on December 10, and 11, 2009, it held a two-day workshop to discuss issues relating to the testing, certification, and labeling of certain consumer products pursuant to section 14 of the CPSA (see 74 FR 58611 (November 13, 2009). [You know, the one last Thursday and Friday with simultaneous panels going on all day on both days. There has been no time to review or consider the data gathered at the workshop, or the written comments which will continue to come in for the next 25 days.] Given the issuance of many rules and other FEDERAL REGISTER documents, statements of policy, and guidance documents [OMG, there were other documents besides these?!], as well as increased understanding of the CPSIA’s requirements, the Commission believes it is appropriate to phase in the testing and certification requirements as described in more detail below.” [This passage is followed by pages of details of stays lifted, extended, partially extended, whathaveyou. It also includes the errant language on the lead content stay.]

I find myself scratching my head in wonder. What is going on here? Is this being staged for effect, or are they SERIOUSLY trying to regulate this way? Is ANYONE accountable over at the CPSC? Can they get away with anything and everything?

It is sickening that a discussion is even necessary for the extension of the stay on lead content. The Commission should hang its head in shame for foisting this mess off on an innocent manufacturing community. What on earth did we do to deserve this treatment? I am tired of this Commission bowing down to Henry Waxman and a howling pack of fear mongering consumer groups. Those people have never worked for actual operating companies and know nothing about the realities of the marketplace or manufacturing itself. It’s time to stop sticking it to the manufacturing community.

The WSJ noted tonight that Congress and Mr. Obama have hit new lows in popularity. I particularly found interesting that 81% of the participants in the new poll considered this “a period of division where the parties held fast to their positions and showed little willingness to compromise” in Congress. Do we really want this export at the CPSC? As a member of the regulated community, I vote no!

Tomorrow’s vote is going to tell us all a lot about this Commission and its leadership. Watch this space for news.

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CPSIA – The Eyes Glaze Over . . . .

CPSIA – CPSC Clears Zhu Zhu Pets . . . But The Damage Can’t Be Repaired

Last week, in the heat of the post-Thanksgiving holiday buying crush, yet another unscrupulous or incompetent consumer group, so the so-called “GoodGuide” out of San Francisco chose to launch an attack on a high-profile toy, the “Zhu Zhu Pet”, specifically “Mr. Squiggles”. The Zhu Zhu Pet product line is this year’s Must-Have Toy, a perfect target for selling papers and promoting fear. Mr. Squiggles’ “crime” was purportedly the presence of microscopic amounts of tin and antimony above the absurdly cautious CPSIA standards for those elements. GoodGuide (for purposes of this blogpost, let’s call them “MisleadingGuide”) cited Mr. Squiggles for having “elevated levels” of the elements in its hair and on its cute little nose. The offending levels: tin (I can’t find the data anywhere) and antimony, 93 ppm on the hair and 103 ppm on the nose. The federal limits under the CPSIA is 60 ppm.

The MisleadingGuide report was issued on Saturday Dec. 5, and to the CPSC’s credit, it acted promptly today by announcing its intention to swiftly investigate, and later (on the same day), cleared the toys. In response to the storm over its accusations, MisleadingGuide acknowledged that it used a XRF gun to test the surface and did not use the federal wet test methods. Oopsie-daisy! MisleadingGuide apparently regrets its error. Interestingly, the retraction/correction of MisleadingGuide is nowhere to be found on its review of Mr. Squiggles. The MisleadingGuide rating is also unchanged as are the misleading results that MisleadingGuide says it “regrets” but hasn’t gotten around to correcting. Notably, in the small print of one of its disclaimers, MisleadingGuide notes that much of its data comes from consumer group luminaries regularly heralded in this space such as HealthyToys.org and the ever-present Center for Environmental Health. Now that’s some fine company!

This very sorry and sickening episode is the latest instance of consumer group terrorism playing up to an easily panicked and understandably rattled American public. Using the imprimatur granted by their self-appointed role as protectors of public welfare, consumer groups nowadays shoot first and ask questions later. An unskeptical media republishes their garbage without comment, other than to whip up the flames of fear. The cost and the consequence is the random devastation of businesses for “crimes” that are very often imaginary. In this case, the tiny company responsible for this monster hit has only 16 employees. Not exactly a Mattel with a large in-house legal department or the other resources of a mega-company accustomed to being kneecapped by Naderites. A real U.S. success story – brought low by consumer group incompetence and irresponsibility. As everyone knows, there is no recourse for these entrepreneurs as their franchise is damaged mid-Christmas selling season. Dreams dashed, and the consumer groups hardly even blink. Of course, MisleadingGuide does “regret” its error. A bit of cold comfort for the 16 employees at Cepia as they examine the lumps of coal in their Xmas stockings.

Part of the consumer group M.O. is to stoke fear by tossing around figures that no one understands. In this case, they chose some new, unfamiliar elements to create the illusion of irresponsibility by a toy company. Tin? Antimony? I thought the culprits these days were lead and phthalates? No, when those items fade, new threats are manufactured to spread fear and distrust. I should point out that MisleadingGuide is arguing about being 33 and 43 PARTS PER MILLION over the new federal limit.

Tin and antimony are not radioactive, these ultra-amounts are basically undetectable. There is no indication anywhere that exposure to an incremental amount of these elements at this level would be dangerous. However, the new standard is misleadingly portrayed by these unscrupulous or unsophisticated consumer groups as a human health exposure limit, reasoning that anything above the limit is a sign of DANGER. The press is all too willing to make their claims seem legitimate: “Tests in animals have attributed a series of ailments large-scale consumption of antimony, the Department of Health and Human Services’ (DHHS) Agency for Toxic Substances and Disease says. Yet the DHHS also says it does not ‘know what other health effects would occur to people who swallow antimony.’” Ah, the seeds of doubt! Notably, unless you gorge on Zhu Zhu Pets regularly, large-scale consumption of antimony is irrelevant in this case. This kind of reporting hands a “win” to the consumer groups. The losers outnumber the winners by a wide margin.

I think there are many damaged parties in this pathetic episode. Let me list them:

• You. The American consumer loses EVERY TIME as confidence in our neighbors and in our stream of commerce is nicked again and again by nincompoops who spread salacious gossip and commercial slander without a full and thoughtful investigation.
• Science. The abuse of science will eventually lead to a mistrust of science. Science misused for the purposes of raising contributions or gathering proceeds from fines or contingent legal fees discredits it as a source of understanding of our world. Our country will lose out to countries not as obsessed with small-minded paranoia.
• Specialty Markets and Small Business Interests. What kind of crazies want to do business in this environment where consumer group terrorists rule the planet? Business people read these articles and feel an injury to themselves. We all know we could be next. It’s random and unpredictable, since junk science can be deployed anywhere and anytime by the evil tandem of an unquestioning press and unscrupulous consumer advocates.
• Our National Competitiveness. By allowing consumer groups to pick innocent victims without recourse for the tortious devastation they cause, the incentive to innovate or even trade is sharply curtailed. Businesses seek exits, not growth – some jobs program, huh? The costs imposed on healthy businesses to stay ahead of the maniacs will further cripple competitiveness. As a nation, we will gradually sink into an abyss of irrelevance.

How long must we tolerate consumer group terrorists? I think it’s time for Congress to create a new cause of action against this kind of irresponsible behavior. Someone needs to be accountable for the spreading of misinformation, damaging innocent and honest American businesses trying to create jobs and provide needed products and services to American families and schools. The torts of the consumer group creeps need a remedy. Let’s turn the tables on these fronts for plaintiff’s attorneys and take back our country.

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CPSIA – CPSC Clears Zhu Zhu Pets . . . But The Damage Can’t Be Repaired

CPSIA – Tenenbaum Challenge Update!

It’s been two days, and still no reply from the CPSC on my rhinestone challenge. Next time I think my challenges need a time limit. Since I have had two more days to think about rhinestones, I have another challenge for Ms. Tenenbaum: Provide ONE example of a child (not deranged) that has accidentally or inappropriately ingested 50 of anything since the Pilgrims landed at Plymouth Rock in 1620. I don’t think it’s happened in the United States EVER. [ Non sequitur : There is a Plymouth Rock in Wisconsin and when my kids were younger, I used to ask them to tell me how the Pilgrims managed to land in the middle of Wisconsin of all places. Imagine the surprise . . . . Okay, I guess I give hard challenges at times.] I was discussing the dilemma of rhinestone-eating children with my brother-in-law who is an Emergency Room Physician. He noted that in his 22-year career, he has seen only ONE case of a child ingesting more than one object, namely two quarters. He does see many cases of childhood ingestion of a single object (typically, a coin, spring or a paperclip – no mention of rhinestones but then again, he’s only been on the look-out for 22 years). He said that the only cases of multiple foreign body ingestion he sees is pills. I guess the Hot Dog Eating Champ must not have gotten his start in bracelets or earrings. This got me to thinking . . . . I poked around on the Internet to see what statistics I could find on foreign body ingestion by kids. I didn’t want to be embarrassed by the sudden appearance of statistics that showed that children regularly chow down on bracelets, rings and necklaces laced with “dangerous” rhinestones, or that they suck the jewels off their jeans and shoes with regularity. Turns out the Internet is chock-a-block with data on this topic. Interesting . . . . Here’s data from “Foreign-Body Ingestion in Children: Experience With 1,265 Cases”, Journal of Pediatric Surgery, Vol. 10, No. 10 (October, 1999), pp. 1472-1476 (I paid $31.50 to bring you this exciting news): Table 1. The Categorization of Foreign Bodies Ingested by Children Coins : 271 cases (49% of cases) Fish bones : 155 cases (28 %) Metallic objects : 78 cases (14%) [7 batteries, 41 sharp objects (needles, pins, screws, and wires), 30 blunt objects (keys, metal caps)] Other bones : 16 cases (2.9%) [8 chicken bones, 7 pork bones. 1 duck bone] Rubber and plastic material : 10 cases (1.8 %) Glass objects : 7 cases (1.3%) [2 glass objects, 5 glass marbles] Others : 15 cases (2.7%) [3 (shrimp &crab shell), 1 seed, 1 ginger, 1 denture, 2 wooden material, 7 unknown objects ] Total: 552 cases (100 %) This data summarizes the cases with endoscopically or radiologically proven foreign body ingestion. The study covered a period from 1964 to 1997 in one tertiary referral center. No jewels mentioned in the article. Hmmm. Another article (” Guideline for the management of ingested foreign bodies ” from American Society For Gastrointestinal Endoscopy, Vol. 55, No. 7, 2002, pp. 802-806) notes: “The majority of foreign body ingestions occur in the pediatric population with a peak incidence between ages 6 months and 6 years. In adults, true foreign object ingestion occurs more commonly among those with psychiatric disorders, mental retardation, or impairment caused by alcohol, and those seeking some secondary gain with access to a medical facility. Ingestion of multiple foreign objects and repeated episodes are not uncommon. Edentulous adults are also at greater risk for foreign body ingestion, including of their dental prosthesis.” In other words, crazy adults will eat multiples, but not kids. This article mentioned coins and batteries, but did not address jewels or jewelry. Yet another article points to coins and chicken and fish bones as the most common childhood ingestion objects. The American Family Physician, a publication of the American Academy of Family Physicians has an information sheet about accidental ingestion – again, no special mention of jewels or swallowing 50 of anything. There’s a lot of articles out there which provide consistent data. This gets even more interesting if you check out Ms. Tenenbaum’s citations in her statement supporting her vote to reject the exclusion request on rhinestones, crystals and glass beads. From her statement: “Moreover, emergency room data collected through NEISS shows that jewelry is one of the top five items ingested by children.” Wow, that’s a shocker, isn’t it? In my house, the top five items ingested by children are potato chips, bagels, pop tarts, hamburgers and fries. I thought I would check out the NEISS data, just for kicks. One CDC report summarizes the data as follows: of 17,537 choking incidents among children under 14 years of age in 2001, the percentages break down as follows: 29.6% Solid Food, 19.0% Candy/Gum, 18.7% Other Non-Food, 12.7% Coins, 9.0% Unknown, 7.6% Liquids, 3.4% Unspecified Food. The category including jewelry is Other Non-Food, which is described as “Includes toys, marbles, balloons, puzzle pieces, paper, pen caps, tape, screws and other hardware, keys, plastic, cellophane, plants, rocks, jewelry, hair accessories, soda can tabs, and other specified nonfood items”. Hmmm. Seems quite unlikely that jewelry is the fifth largest category of ingested items. Another report from the Commonwealth of Massachusetts hinted that the NEISS data Ms. Tenenbaum may have been referring to was from 2000-2005. You can’t run a query on six years of data at once on NEISS. I ran a query for 2005 to see what I would find. The number of ingestion incidents reported were 2205. The number of incidents coded to jewelry (class 1616) was 125 or 5.7%. This is similar to the data provided by the Massachusetts report (6.6%) so I decided lazily to accept it as directionally representative of the data apparently used by Ms. Tenenbaum. Of the 125 cases, however, 30 were for kids 6-22 months old, 41 for kids 2-6 years old. 15 for kids 7-12 and the balance for older kids through adults. Thus, the number of cases reported in 2005 for the targeted 0-6 age group was not 5.7% but instead 71/2205 or 3.2%. The data is difficult to interpret, although there are short case descriptions for each line of data. I would guess with high confidence that many (if not most) of the 71 target market cases are either beads (not relevant here but classified as jewelry all the same) or adult jewelry (several cases of swallowing nose rings and tongue rings). Many of the reported cases are not certain but noted simply as “possible” swallowings – and thus cannot be rigorously considered part of the “hard” data. This is consistent with the other literature that discusses ingestion of foreign bodies – many cases cannot be confirmed. For this reason, I strongly doubt that 3.2% of all ingestion cases in 2005 can be fairly applied as evidence supporting a ban on rhinestones. There were apparently no cases of a child eating a drawer full of jewelry in 2005, either. Notably, there were a couple cases of a child actually swallowing a bracelet. I guess it’s possible. Anyhow, the data does not support the likelihood of a child EVER ingesting 50 rhinestones. It is farfetched. The conclusion I reach is that any contention that swallowing 50 rhinestones is a real risk or a real health problem is simple nonsense. It is offensive to me that our regulators are using data they may not understand or which is “dirty” (muddied with inappropriate or irrelevant entries, tending to mislead the viewer of the data). Given the apparently ridiculously low or nonexistent risk of swallowing 50 rhinestones, the CPSC safety regulators seem to be defending their legal conclusion simply for its consistency with the CPSIA but dressing it up with misleading fear mongering data to make it appear that they are actually making a rational decision. This may please Mr. Waxman and the consumer groups who apparently think the business community is evil, but it is wrong. As I said in an earlier post , this approach may bring short term benefits to the agency, but in the long run, the sacrifice of integrity and reputation will be extremely costly to all concerned. If I am mistaken, Ms. Tenenbaum, please correct me.

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CPSIA – Tenenbaum Challenge Update!

CPSIA – A Challenge to Inez Tenenbaum

In today’s House hearing featuring CSPC Chairman Inez Tenenbaum, the subject of rhinestones (crystal beads) came up. At about the 1:42 point in her testimony , Rep. George Radanovich asked her about the real health risk posed by crystal beads in the context of his concern over the agency’s need for the flexibility to use risk-based analysis. Ms. Tenenbaum contended that “interpretation” of her comments on crystals have “muddied the waters”. She defended the banning of rhinestones on the basis that although crystal beads might not violate the previous “substantial injury or illness” standard of the FHSA, some beads have higher concentrations of lead that violate the new CPSIA standard. [For instance, leaded crystal, hence the name.] Rep. Radanovich questioned whether this matters as a practical safety matter since swallowing a bead is exceedingly unlikely to cause injury from lead. Ms. Tenenbaum stated that while leaching of lead from one bead poses no problem, “what if the child swallowed 50 small beads?” She goes on to note that the agency “could not determine” whether 50 beads would raise the blood levels of lead. [She apparently concedes that the only potential risk with beads (from lead) is from ingestion, not handling or airborne lead.] I was blown away by this statement from the Chairman of the CPSC. She didn’t sound concerned with safety; instead, she seemed to think that her job was to defend the law she was given to enforce. Her reasoning appears to be made solely in the context of this goofy law. Common sense is only relevant if the law says so, apparently. This leaves us high and dry. Who will stand up for rational safety policy if not her? Her analysis of the risks of swallowing stones is also mindboggling. First of all, and most importantly, in her testimony before Congress today, Ms. Tenenbaum defended setting national safety policy based on our society’s lowest common denominator, a child who would swallow FIFTY BEADS. Yes, she justifies the devastation of several industries and uncountable companies dependent on these decorative stones on the grounds that if a child swallows 50 beads, he/she might get lead poisoning. Remember, we are talking about eating ROCKS here. Who might these children be that swallow 50 beads? Completely unsupervised children at a minimum, for one thing. So Ms. Tenenbaum apparently believes that she must enforce the law in a way that protects children against the total abdication of basic care by parents, teachers and caretakers. [If that is really a sound basis for national policy, Big Brother is going to look good by comparison pretty soon.] Second, only children with real problems (unrelated to product safety) would eat 50 beads (rocks). I personally have never eaten a rock or a bead, have you? These are kids that have serious deficits. So we are trashing all these companies because children of this nature MIGHT be in danger. What percentage of society will benefit from this approach, and at the expense of how many other people? Interesting question? And let’s not forget . . . that if you swallow 50 beads (rocks), you have bigger problems ahead of you than lead poisoning. Amazingly, the Chairman of the CPSC is apparently so absorbed in enforcing this defective law that this important common sense point is seemingly lost on her. Check out her Congressional testimony. She was actually arguing with a member of Congress to defend the decision to ban these stones on this basis. If this isn’t proof of an upside down world, I don’t know what is. How is your confidence in the CPSC now? BUT what if Ms. Tenenbaum is RIGHT? Holy cow, what if you can get lead poisoning from crystal beads? She must have a basis for her assertions, right? Well, I have little kids that pass through my house all the time. As we know, rhinestones are not illegal to OWN, just illegal to sell. I happen to own some rhinestones and now I am WORRIED. So I want to know how Ms. Tenenbaum derived her conclusion that 50 rhinestones poses a health risk. Clearly, a sophisticated agency like the CPSC wouldn’t make such a direct statement in front of Congress without a firm basis for it. So, my challenge to Ms. Tenenbaum is to PROVE that 50 crystal beads are dangerous (as a source of lead poisoning). She told Rep. Radanovich they might be dangerous – now, let’s see the DATA and the MATHEMATICS. I think the U.S. public deserves to see it. But I don’t want to make things too tough on the CPSC. I will help out a bit here. The Fashion Jewelry industry submitted a lot of DATA to the CPSC back in February. I have absolutely nothing else to do with my time and gave up sleeping longggg ago, so I re-read the industry’s data with a calculator in hand. Here’s what I think is the right answer. Ms. Tenenbaum can correct my math if I am mistaken. 1. The industry says that a popular size of rhinestone is 10PP for children six years old and younger (the target market for CPSC enforcement). It takes 333 of this size stone to equal one gram (remember this number). There are typically 10-15 such stones in jewelry for this age group, so to swallow one gram of stones would require eating 20-30 bracelets. Yummy, munch munch. It takes fewer stones to equal one gram for larger stones, but then again, fewer such stones are used in each piece of jewelry, too. You can find the chart in the industry letter on page 8 and look it over yourself. Eating a gram of stones will take a lot of milk, plus access to piles of jewelry. I think it’s an ambitious project for a determined, hungry, totally unsupervised child with access to tools. 2. There’s lead in your food, your water and your air. I have previously gone over some of these numbers (actually more than once ). The industry notes that the FDA has standards for lead in the food supply and sets a provisional tolerable daily consumption limit of 6 micro-grams of lead for children seven years old and younger. This level of consumption of lead theoretically corresponds to a change of one micro-gram of lead per deciliter of blood. The corresponding tolerable consumption levels for kids older than seven is 15 micro-grams of lead per day in food and water. [The FDA doesn't set standards for the lead we breathe all day long, apparently, so let's just ignore that significant source of daily lead intake.] Studies show that daily dietary intakes of lead for children range as high as 1.17 micro-grams of lead on average, well below the standards established by the FDA. If every food was at the maximum lead content, children’s diets might contain as much as 3.5 micro-grams of lead, still okay. 3. The industry submitted studies that showed that, based on ONE GRAM of stones, saline tests leach out 0.15 micro-grams of lead. Acid-extractions tests on ONE GRAM of stones produces leaching of 0.52 micro-grams of lead. To equal the daily intake in an average diet, you would have to swallow (acid extraction test) at least two grams of stones. That’s 666 of the 10PP stones, or the equivalent of up to 70 pieces of jewelry. in an absolute worst case, most unforeseen case, a child would have to swallow 54 30PP stones (11 pieces of jewelry), 210 2-mm stones (about 20 pieces of jewelry) or 22 4-mm stones (4-6 pieces of jewelry). This is to produce ONE MICRO-GRAM of lead intake. [If you are worried about mouthing, multiple the stone count by 3.5.] To raise blood levels by one micro-gram per deciliter of blood, the basic measurable change in lead levels, a child would have to ingest SIX TIMES AS MUCH on a daily basis. For those of you who don’t have access to a calculator or can’t do mental math, this means that to raise blood levels by the minimum amount, you would need to ingest about 130 of the largest reported stones or about 4,000 of the most common ones every day. Based on mouthing only, the number rises to 450+ large stones or 14,000 of the common stones. That’s quite a mouthful. Ms. Tenenbaum, the answer please?

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CPSIA – A Challenge to Inez Tenenbaum

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