CPSIA - My Letter to Inez Tenenbaum (9-17-09)

September 17, 2009

VIA FEDERAL EXPRESS

The Honorable Inez Tenenbaum
Chairman
U.S. Consumer Product Safety Commission
4330 East West Highway
Bethesda, MD 20814

Re: Safety of Rhinestones and Crystals

Dear Chairman Tenenbaum:

I am writing on behalf of the Alliance for Children’s Product Safety, an organization comprised of small businesses in many industries impacted by the Consumer Product Safety Improvement Act (CPSIA).

Of particular concern to Alliance members is the “unintended consequences” of the CPSIA, namely that many safe products will be explicitly or effectively forced from the market despite sterling safety records, and that many viable and law-abiding businesses will be economically crippled (or worse) by new testing, labeling and other obligations and liabilities under the new law.

We are aware of your recent testimony at a CPSIA oversight hearing conducted by the House Subcommittee on Commerce, Trade and Consumer Protection on September 10, 2009. In your testimony, you expressed concern that swallowing “50 beads” (referring to rhinestones, glass beads or crystals) might lead to measurable change in blood lead levels and would hence be considered “unsafe.” You also indicated that your statement of July 17, 2009 explaining your vote to deny the Section 101(b) exclusion request of the Fashion Jewelry Trade Association and other organizations for such beads was “poorly worded,” and the level of lead in such beads was in fact a cause for concern. You mentioned, in particular, beads with lead levels of 23,000 ppm.

We are puzzled by this testimony and kindly request clarification.

Notably, you wrote in your statement of July 17 that “Commission staff recognized that most crystal and glass beads do not appear to pose a serious health risk to children.” You also stated clearly that risk assessment by the Commission “appears to be in direct conflict with the statutory language [of the CPSIA]” and therefore the agency is foreclosed from considering factors such as “bioavailability of lead, accessibility of the lead to children, foreseeable use and abuse, foreseeable duration of exposure, marketing and life cycle of the product” in any exemption proceeding. We are therefore confused by your testimony that your vote against the exclusion request was actually motivated by a safety concern (risk assessment).

The clarity and consistency of CPSC administration of the CPSIA is a serious issue for businesses attempting to comply with the new law. It is well-known that confusion among the regulated industries has caused market chaos and considerable business losses. The rhinestones decision, followed by your recent Congressional testimony, creates serious new issues that will further confuse those trying to comply with the law.

We request that the Commission provide clarification on your July 17 contention that exemption requests will be made without regard to risk assessment. If risk assessment is not permitted by the CPSIA in such proceedings (as has been consistently stated by you as well as by Commissioners Nord and Moore), we request that the Commission explain the relevance of the safety considerations of swallowing 50 rhinestones on the rhinestones exemption request decision. If your testimony before Congress indicates that risk assessment is now permitted in CPSIA exemption proceedings, please explain the legal basis for this change in statutory interpretation.

We believe that the terms of the CPSIA require that the CPSC deny the exclusion request for rhinestones based solely on the lead levels in the stones; however, we do not believe rhinestones, crystals or glass beads present any health issue for children. Rhinestones are well-known to be safe. These stones are a classic “innocent victim” of CPSIA, like so many other safe product classes similarly affected.

We request the information that you used to support your testimony that swallowing 50 beads present a health risk to children. In particular, we believe this conclusion is dependent on two theses:

a. That swallowing 50 beads is a “foreseeable use and abuse”.
b. That swallowing 50 beads will cause a measurable change in blood lead levels (one micro-gram per deciliter of blood).

Likelihood of Swallowing 50 Beads. Based on a review of medical literature, the risk of swallowing 50 beads is minimal for “normal” children. For instance, in "Foreign-Body Ingestion in Children: Experience With 1,265 Cases", Journal of Pediatric Surgery, Vol. 10, No. 10 (October, 1999), pp. 1472-1476, the authors document 552 cases of proven foreign body ingestion but do not indicate any record of jewels being ingested. Although NEISS data (this author reviewed data from 2005) shows that jewelry is known to be ingested by children, many cases in the database are not proven (merely suspected) or involve products not relevant to this issue, and in the vast majority of cases, the swallowing are inadvertent or accidental. The accidental nature of ingestion of jewelry is quite relevant here, as the accidental ingestion of four bracelets or 20 rings in incontestably improbable. In addition, such a serious incident would take a great deal of time and an intent to create mischief, none of which is considered a “foreseeable use and abuse” of a children’s product. It is notable that rhinestones are not meant to be ingested, have no flavor or smell and are, in fact, rocks. Rocks are not food and are unlikely to be ingested by children with normal mental health or normal intelligence.

On February 2, 2009, the Fashion Jewelry Trade Association and related organizations submitted a request for exclusion of these stones from the lead limits of the CPSIA under Section 101(b) (the “February 2 Letter”). In that letter, they provided industry data on the use of decorative stones in jewelry. Notably, the February 2 letter indicates that jewelry intended for children six years or younger contains between 4-15 stones. Thus, a child of six years of age or younger would have to consume 4-13 pieces of his/her jewelry to swallow 50 beads. This appears to be a highly unusual event.

We therefore request that CPSC provide data supporting your contention that swallowing 50 beads is a “foreseeable use or abuse” of children’s products containing rhinestones, crystals or glass beads..

Likelihood of Blood Lead Level Changes. In their February 2 letter, the Fashion Jewelry Trade Association and related organizations provided a technical study entitled “Evaluation of Lead in Crystal Beads and Rhinestones” prepared by the respected consulting company, Exponent. In its study, Exponent calculates the lead leaching rate of rhinestones (with lead levels in excess of 600 ppm) in saline (mouthing, 0.15 micro-grams per gram of stones) and acid extraction (ingestion, 0.52 micro-grams per gram of stones). Likewise, it notes that one gram of the most common size of such stones (10PP) equal 333 stones. [Obviously, larger stones require fewer stones to reach one gram in mass, but the analytical results are similar.]

Studies of the daily intake of lead for children demonstrate that lead is present throughout the food system and is present in our air and water as well. As a consequence, children will inevitably consume lead throughout the day by simply breathing, eating and drinking water. [It is well-accepted that the largest source for childhood lead is house paint, followed by dirt and air.] A recent study of dietary intake of lead by children in India indicates that tolerable daily intake of lead far exceeds 10 micro-grams per day (see “Dietary and Inhalation Intake of Lead and Estimation of Blood Lead Levels in Adults and Children in Kanpur, India”, Risk Analysis, Vol. 25, No. 6, pp. 1573-1588, December 2005). Similarly, the Exponent study submitted on February 2 indicates that the FDA has determined that six micro-grams of lead per day is required to produce a one micro-gram of lead per deciliter change in blood lead levels in children six years old or younger. Thus, to produce such a change in blood lead levels from jewels would require sustained daily ingestion of 12 grams of stones (roughly 4,000 stones or hundreds of pieces of jewelry) or mouthing of 42 grams of stones (roughly 14,000 stones or more than 1,000 pieces of jewelry). Clearly, this is unlikely to occur, particularly accidentally.

It goes without saying that ingestion of 50 beads is far more likely to result in physical injury because of intestinal blockage or similar maladies than from lead poisoning. We do not believe any NEISS cases involving the accidental ingestion of jewels were considered a lead poisoning risk by the attending physicians. We kindly request that the CPSC provide data on any incident in the NEISS database documenting that the attending physician considered lead poisoning a risk from the ingestion of jewels.

We also kindly request that the CPSC provide back-up data and analysis to support your assertion that the CPSC “could not determine” whether swallowing 50 beads will cause a measurable change in blood lead levels.

The Need for Flexibility. Finally, we note that in last week’s hearings, Rep. George Radanovich asked you whether you needed “flexibility so [you] can exempt safe products”. You replied that it was ‘premature” for you to answer that question. We are concerned by your unwillingness to answer this question definitively and kindly request an explanation as to why it is “premature” to ask for flexibility to exempt safe products from the lead limits of the CPSIA. Given that the agency has a limited budget, please explain how the Commission will deploy its resources to regulate and supervise safe products, when the need to deal with unsafe products or safety risks is so overwhelmingly large.

Thank you for your prompt consideration of this important matter.

Sincerely,

Richard Woldenberg
Chairman
Alliance for Children’s Product Safety

cc: Commissioner Robert Adler
Commissioner Thomas Moore
Commissioner Nancy Nord
Commissioner Anne Northrup

CPSIA - CPSC Commissioners Speak Out

From: Rick Woldenberg
Sent: Sun 2/8/2009 3:09 AM
To: 'Christian.Fjeld@mail.house.gov'; 'robin.appleberry@mail.house.gov'; andrew_grobmyer@pryor.senate.gov; james_reid@rockefeller.senate.gov
Cc: 'brian.mccullough@mail.house.gov'; 'shannon.weinberg@mail.house.gov'; 'william.carty@mail.house.gov'; 'mjg@brown-gidding.com'; Etienne Veber; 'challengeandfun@gmail.com'; 'kathleen@fashion-incubator.com'; 'Stephen Lamar (slamar@apparelandfootwear.org)'; 'Nancy Nord (nnord@cpsc.gov)'; 'Joe Martyak (jmartyak@cpsc.gov)'; 'Mary Toro (MToro@cpsc.gov)'; 'tmoore@cpsc.gov'; 'Patrick Magnuson (patrick.magnuson@mail.house.gov)'; 'Carter Keithley (ckeithley@toy-tia.org)'; 'Rick Locker (fblocker@LockerLaw.com)'; 'Desmond, Edward'; 'David Callet (calletd@gtlaw.com)'; 'ravitz.georgia@arentfox.com'; 'Pamela Gilbert (pamelag@cuneolaw.com)'; 'Robert Adler'; 'Dan Marshall (dan@peapods.com)'; 'erik.lieberman@mail.house.gov'; 'cfalvey@cpsc.gov'; Judy Bailey (judith.bailey@mail.house.gov); adele@narts.org; kmchugh@astratoy.org; richard.goldberg@mail.house.gov; matthew.abbott@mail.house.gov; 'Brian_hendricks@hutchison.senate.gov'; 'david@commerce.senate.gov'; 'Cathy.hurwit@mail.house.gov'; pweller@cpsc.gov; mgougisha@cpsc.gov; bridget_petruczok@boxer.senate.gov; michael_daum@cantwell.senate.gov; bill_ghent@carper.senate.gov; hap_rigby@demint.senate.gov; frannie_wellings@dorgan.senate.gov; david_quinalty@ensign.senate.gov; james_chang@inouye.senate.gov; jonathan_becker@klobuchar.senate.gov; michelle_schwartz@lautenberg.senate.gov; lee_dunn@mccain.senate.gov; sonya_wendell@mccaskill.senate.gov; matthew_hussey@snowe.senate.gov; brendan_plack@thune.senate.gov; hugh_carroll@wicker.senate.gov; elissa.levin@mail.house.gov; christopher.schepis@mail.house.gov; theresa.lavery@mail.house.gov; greg.louer@mail.house.gov; brian.diffell@mail.house.gov; amy.ingham@mail.house.gov; laura.vaught@mail.house.gov; matt.johnson@mail.house.gov; saul.hernandez@mail.house.gov; aaron.shapiro@mail.house.gov; rick.axthelm@mail.house.gov; steve.plevniak@mail.house.gov; scott.cleveland@mail.house.gov; jonathan.smith@mail.house.gov; pat.cavanagh@mail.house.gov; rachelle.wood@mail.house.gov; michael.gaffin@mail.house.gov; angela.manso@mail.house.gov; dana.lichtenberg@mail.house.gov; derrick.ramos@mail.house.gov; elizabeth.stack@mail.house.gov; lori.pepper@mail.house.gov; david.bahar@mail.house.gov; mark.bayer@mail.house.gov; Neeta.Bidwai@mail.house.gov; kyle.victor@mail.house.gov; chris.debosier@mail.house.gov; morgan.jones@mail.house.gov; matthew.dockham@mail.house.gov; tuley.wright@mail.house.gov; cade.king@mail.house.gov; betsy.christian@mail.house.gov; chris.herndon@mail.house.gov; Mike.Ward@mail.house.gov; laura.abshire@mail.house.gov; randi.meyers@mail.house.gov; Greta.Hanson@mail.house.gov; liz.muro@mail.house.gov; jamie.euken@mail.house.gov; jon.oehmen@mail.house.gov; brad.schweer@mail.house.gov; michael.beckerman@mail.house.gov; valerie.henry@mail.house.gov; Becky.Claster@mail.house.gov; tiffany.guarascio@mail.house.gov; jeff.mortier@mail.house.gov; Christopher_day@billnelson.senate.gov; john_phillips@kerry.senate.gov; Kerrie Campbell (kcampbell@manatt.com); bryan_hickman@hatch.senate.gov; Ben.Kershaw@mail.house.gov; tom_jones@commerce.senate.gov; Lisa Brown (lbrown@who.eop.gov); csunstein@who.eop.gov; stacy_ettinger@jec.senate.gov; csunstei@uchicago.edu; rpalmieri@nam.org; dbrown@muchshelist.com
Subject: CPSIA - CPSC Commissioners Speak Out

Have you read the statements of Commissioners coming out of the CPSC lately? The statements of Commissioners Nancy Nord and Thomas Moore of the CPSC given after the rejection of the NAM petition for a stay of the new lead standards under the CPSIA (https://mail.learningresources.com/exchweb/bin/redir.asp?URL=http://cpsc.gov/library/foia/ballot/ballot09/nam.pdf), as well as their statements given in support of the new interim final rule exempting certain items from the lead standards (https://mail.learningresources.com/exchweb/bin/redir.asp?URL=http://cpsc.gov/library/foia/ballot/ballot09/101lead.pdf) are very revealing.

Rejection of the NAM Petition. As my recent letters confirm, the NAM petition decision was a foregone conclusion, as the CPSC is prohibited under Sections 101(b)(1) and 101(e) of the CPSIA from changing the new standards in any way for any product. Thus, the CPSC was legally prohibited from staying the new lead standards and the Commissioners made the legally proper decision to vote down the petition under your CPSIA. Interestingly, as another of my recent letters notes, after Acting Chairman Nord made this very point in writing to Representative Waxman et. al. in her letter of January 30, those House and Senate leaders responded on February 3 by demanding that she resign. Some great open dialogue there!

The NAM petition, it should be noted, focused on the retroactive CPSIA lead standards because the NAM letter preceded the NRDC phthalates case decision last Thursday. Presumably, had NAM known that the phthalates ban would become retroactive instantaneously two business days before its February 10 effective date; their request would have included a stay request on the phthalates ban, too. Alas, we cannot wind back the clock, so the Commissioners did not consider this issue. They would have been legally prohibited from taking any action on the phthalates standard, of course, but the Commissioners would have been free to comment on it. In the below discussion, I believe you can safely read between the lines and infer parallel references to phthalates in the Commissioners discussion of the issues.

The statements of Nord and Moore are quite informative. After reiterating the fact that the Commission is prohibited from staying the lead standard, Ms. Nord notes: "Rather than applying the lead content provision to products manufactured after the effective date, Congress applied it to all products out in the stream of commerce on February 10, sitting in container ships, in warehouses, and on store shelves. CONGRESS HAS NEVER BEFORE ENACTED SUCH A SWEEPING CONSUMER PRODUCT PROVISION IN A RETROACTIVE MANNER AND THE DISRUPTIVE RESULTS OF THIS PROVISION ARE NOW BEING SEEN IN PAINFUL WAYS." [Emphasis added] Of course, Ms. Nord overlooks the Prohibition as a precedent for this dramatic legislative overreaction.

Ms. Nord goes on to note several impacts on trade, including removal of product from store shelves out of fear, disrupted buying by retailers and the prospect of widespread loan defaults. All old news, if you read my emails. Importantly, Ms. Nord states in conclusion: "CONGRESS SPOKE CLEARLY IN SETTING OUT A REGULATORY REGIME THAT APPLIES TO ALL CHILDREN'S PRODUCTS IN COMMERCE REGARDLESS OF EXPOSURE TO ACTUAL RISK. CONGRESS SPOKE CLEARLY ABOUT THE LIMITED NATURE OF THE EXCLUSIONS AND EXEMPTIONS AVAILABLE UNDER THE LAW. CONGRESS SPOKE CLEARLY ABOUT THE LIMITED NATURE OF OUR ENFORCEMENT DISCRETION AFTER FEBRUARY 10. THE AGENCY CANNOT AMEND OR CHANGE THE STATUTE." [Emphasis added] Happy days, indeed.

Commissioner Moore takes a different tack when discussing the NAM petition. After reciting various administrative activities of the Commission relating to lead over the years, he attacks the integrity of the business community: "It would have been hard for a manufacturer of children's products to miss the clear message that they needed to get the lead out of children's products well in advance of final congressional action." It’s always helpful to have a “bad guy” to bash. Other than the fact that lead poisoning is virtually unknown in children's products outside of lead-in-paint (illegal for decades) and that the CPSC has always administered safety matters by examining the actual quantifiable risks, Mr. Moore might be right. However, responsible businesspeople concentrate on real consumer risks, and have no reason to concern themselves with the ebb and flow of possible arbitrary movements in the nation's regulatory scheme. Until recently, safety administration in this country was rational – is it really “foreseeable” that the legal standard would detach itself from risk so profoundly? In truth, periodic CPSC administrative activity over many years in relation to very specific circumstances is hardly a damning fact pattern revealing a dim-witted, oblivious or pernicious business community.

Further rationalizing his condemnation of protests against the CPSIA, Commissioner Moore states his belief that "certain Hill staffers were assured by various segments of the children's product industry, that there would NOT BE A PROBLEM with meeting the 600ppm standard as most already were." [Emphasis added.] What a wonderfully open and accountable process Mr. Moore recites. It's a shame that Commissioner Moore chose not to attach names, dates or written testimony to such hazy assertions. In any event, it’s really not the standard itself that is the business community issue, but instead the breadth of the definition of products subject to the standard and the costs associated with PROVING COMPLIANCE with the standard and otherwise complying with the law.

Mr. Moore clarifies that "[t]his does not mean I am not sympathetic to resellers and home crafters who are trying to figure out how to comply." Mr. Moore gives the impression that he believes opposition to this law comes only from marginal groups of unsophisticated people. In fact, the businesses impacted by the CPSIA are big and are small, and span industries like footwear, apparel, publishing, thrift stores, online marketplaces like eBay, toys, housewares, school supplies, furniture, bicycles, office supplies, sports equipment, novelties, incentives - and yes, crafters. Notably, this wide group of businesses certainly understands business law as a general matter. The law speaks for itself, and we have read it.

Interim Final Rule Exempting Certain Electronics Items. In her statement on this decision, Ms. Nord notes that the hurry-up process used to issue the complex policy Congress demanded was driven by the agency’s inability to stay the lead standards: “This is not a procedure that I anticipate the agency will use in the future, except under the most demanding circumstances.” Could something important have been missed? Apparently Congress only wants true, peer-reviewed science utilized when opponents attack its bill. Interestingly, Ms. Nord also notes that the CPSC no longer controls how safety is policed in the United States because there are now 50 shadow CPSC’s to dog the business community: “I also HOPE the state attorneys general will follow our lead and adopt similar enforcement policies.” [Emphasis added.] In our business, we say “hope is not a strategy”. I take little comfort in Ms. Nord’s plea.

Commissioner Moore adopts a more conciliatory posture in his statement, as though we might not have read his other attacks on business: “The Commission will take a measured, reasonable approach to administering the new law. We will be patient with businesses working to come into compliance . . . .” I would note that every communication that the CPSC has put out in recent weeks has asserted the importance and inflexibility of the new standards, including the need to self-report for seemingly any known violation. Does this mean that the CPSC won’t force recalls for these self-reported violations? That seems contrary to everything I have read from the CPSC and Congress lately. I take cold comfort in Commissioner Moore’s soothing words – the CPSC’s stated policies are otherwise. He goes on: “We have always focused on protecting the consumer over penalizing the inadvertent missteps of small businesses. I see no reason for that approach to change under the new laws . . . .” This might be true (I certainly hope so), except that now the safety rules are absolute and the agency has little discretion left in its administration of these rules, so whether missteps are “inadvertent” won’t matter AS A MATTER OF LAW. Furthermore, the range of legal requirements has spiraled out of control, leaving the task of compliance beyond the capability of 99% of all companies (in the real world). There will be plenty of missteps to review and consider.

The concerns of the business community are legitimate and are URGENT. You MUST take action right now to stay this "awful law" (see WSJ Editorial dated February 6 https://mail.learningresources.com/exchweb/bin/redir.asp?URL=http://online.wsj.com/article/SB123388626627155299.html). You have been notified AGAIN AND AGAIN about the many problems created by the carefully crafted language of the CPSIA. The financial consequences to many businesses will begin to become apparent in just a few short days without your action. Whether you agree or disagree with my position, sufficient doubt has been created to merit “hitting the pause button” allowing for further hearings and open discussion of the impact of this law. The public health “crisis” is imaginary and does not justify the horrifying risks you are taking with the U.S. economy.

Sincerely,

Richard Woldenberg
Chairman
Learning Resources, Inc.
rwoldenberg@learningresources.com
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