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