NOTE: The following is one of a series of case studies produced by the Union of Concerned Scientists' Scientific Integrity Program between 2004 and 2010 to document the abuses highlighted in our 2004 report, Scientific Integrity in Policy Making.
The U.S. Consumer Product Safety Commission (CPSC) twice altered their scientific testing procedure before concluding that children's lunch boxes containing levels of lead that exceeded Federal recommendations were in fact safe. Lead is a powerful neurotoxin in children, and can cause brain damage, mental retardation, behavioral problems, liver and kidney damage, and in extreme cases, death.1
The CPSC declared in September 2005 that they found "no instances of hazardous levels" of lead in their testing of 60 soft, vinyl lunchboxes,2 and then refused to release their experiments, saying federal regulation protected the product manufacturers from having such information released to the public.3 A year later, Freedom of Information Act (FOIA) documents obtained by the Center for Environmental Health (CEH)4 and the Associated Press showed the CPSC manipulated its data to produce artificially "safe" results.5 The FOIA documents reveal that the CPSC had actually tested fewer than ten lunchboxes at the time of their statement, and that these already had indications of high lead levels. Following these first tests, CPSC then changed the testing procedure until a "safe" level of exposure was recorded.6
There are numerous federal standards regarding lead exposures in human blood, ambient air, workplace environments, food, drinking water, and paint, but no overall federal ingestion standard exists.7 The Centers for Disease Control and Prevention (CDC) advises that 10 µg/dL of blood is a level of concern for children; the latest science suggests that blood levels below this can also cause loss of IQ in children and there really is no safe level of lead ingestion.8 Based on the CDC's levels, the FDA's daily Provisional Total Tolerable Intake Level (PTTIL) for lead for children under the age of six is 6 micrograms per day (µg/day).9 The CPSC's regulation for lead content in paint is 0.06% by weight (600 parts per million).10
The lead detected in these lunchboxes, clearly marketed to children with graphic designs and superhero images,11 is a component of the flexible polyvinyl chloride (PVC) linings which can be found on the inside and outside of the bag.12 The CPSC originally tested the bags by dissolving a sample of the vinyl and determining its actual lead content;13 this procedure showed 20 percent of the lunchbags were over the federal safe level of lead for paint.14 The highest recorded value was for a "Spiderman lunch box," whose value of 0.960% by weight was over 16 times the standard.15
The CPSC then changed their testing procedure to a "swipe test" which they intended to simulate a child's hand or food contacting the surface of the bag.16 The first round of these swipe tests recorded the total amount of lead removed from a 100 cm2 area (approximately 4 inches by 4 inches) after four wipes.17 When these tests yielded values greater than the lead PTTIL value, the CPSC changed their procedure again by averaging the swipes (instead of adding) from the same location of the bag and increasing the total number of swipes from 4 to 30.18
This new procedure significantly lowered the amount of lead reported for each lunchbox, since each swipe over the same area yields less lead. For example, the CPSC results for one lunchbox with a "comic" logo19 involved using three wiping pads to test the lunchbox, with each pad being swiped on the lunch box ten times.20 The first wipe pad was recorded at 11.674 µg (already 5.674 µg above the daily limit for children under six), the second contained 4.198 µg, and the last wipe had 1.069 µg. The cumulative amount of lead was 16.940 µg, which is almost three times the PTTIL value. However, the CPSC then averaged that value over the 30 swipes, and ended with a final "average" exposure value of 0.565 µg.21
An internal email from a CPSC scientist stated that this change in procedure "shows (or I guess HS will say that this shows) that the overall risk is lower than our original testing would have showed, as the amount of lead dislodgeable is mostly taken out with the first wipe and goes down with subsequent wipes."22 It is unclear whether "HS" here refers to CPSC Chairman Hal Stratton or, as CPSC claims, the Directorate for Health Services.23
Critics at CEH claim using an average exposure value is ridiculous, since lead accumulates in the body. "Using an average exposure for lead from lunchboxes is like telling a parent, 'here's a pile of paint chips, and some contain high levels of lead, but many contain very low levels, so it's OK for your child to eat the whole pile, because on average the exposure is low.' It's complete nonsense," says CEH researcher Alexa Engelman.24
In a move which has been hailed by representatives of the vinyl industry,25 the CPSC is continuing to stand by its testing procedures, claiming that "recent news reports and postings on special interest group web sites have provided information that incorrectly interprets the findings of the [CSPC]" and these "inaccuracies needlessly unnerve parents."26 But the Food and Drug Administration (FDA) disagrees; its review of the CSPC studies prompted a letter to vinyl lunchbox manufacturers and suppliers urging "companies to refrain from marketing such lead-containing lunchboxes" as "some migration of lead to food… may be reasonably suspected." The letter warned the companies that the lead might be considered a food additive, and therefore subject to regulation through the Federal Food, Drug, and Cosmetic Act.27
CSPC now faces probing questions and possible hearings from Democrats on the House Energy and Commerce Committee.28 In a letter to the FDA and CSPC, Reps. John Dingell (D-MI), Bobby Rush (D-IL), Jan Schakowsky (D-IL) and Ed Markey (D-MA) express serious concern about the allegations of data manipulation and misinformation to the public, stating "if the implications are true, we are appalled."29
The CSPC has failed to protect children from hazardous levels of lead on soft, vinyl lunchboxes by rewriting their own science and then repeatedly telling the public the bags pose no health risk. Also, since the tests were only conducted on lunchboxes in pristine condition, it is unclear if natural wear on the bags will release more lead from the vinyl. As Rep. Dingell said, "I don't know what is more troubling – the fact that the Consumer Product Safety Commission knew about the hazardous levels of lead in the lunch boxes that were tested or the fact that noting was done to prevent them from getting into the hands of children."30
1. U.S. Environmental Protection Agency. Addressing Lead and Superfund Sites. Accessed July 12, 2007.
2. Consumer Product Safety Commission. Q&As: Vinyl Lunch Boxes. Accessed July 12, 2007.
3. Mendoza, Martha. Tempest in a lunch box: How the government decided lead levels were OK. The Associated Press. Feb 18, 2007.
4. Center for Environmental Health (CEH).
6. Center for Environmental Health. Consumer Protection Agency Covered Up Risks from Lead in Children's Lunchboxes. Feb 18, 2007.
7. Agency for Toxic Substances and Disease Registry, Department of Health and Human Services. Case studies in environmental medicine: Lead Toxicity. Standards and Regulations wepage. Accessed July 12, 2007.
8. For example, see the report by the American Association of Pediatrics, Committee on Environmental Health. Lead exposure in children: Prevention, detection, and management. Pediatrics 2005; 116:1036-1046. Also, Lanphear et al. Low-level environmental lead exposure and children's intellectual function: An international pooled analysis. Environmental Health Perspectives. Vol 113. No 7. July 2005.
9. U.S. Food and Drug Administration. Supporting document for recommended maximum level for lead in candy likely to be consumed frequently by small children. Nov 2006. Federal Register, Vol. 58, pg. 33860, June 21, 1993.
10. Agency for Toxic Substances and Disease Registry.
11. FOIA documents sample. Provided to the Union of Concerned Scientists by CEH.
12. U.S. Food and Drug Administration (US FDA), Center for Food Safety and Applied Nutrition. Letter to Manufacturers and Suppliers Concerning the Presence of Lead in Soft Vinyl Lunchboxes. July 20, 2006. Accessed July 12, 2007.
13. CEH FOIA documents. Procedure for total lead content tests performed on Sept 19, 2007 can be seen on the document: Laboratory continuation for sample number 05-840-7336.
15. CEH FOIA documents. Laboratory report for product: Spiderman lunch boxes, Sample number 05-840-7337. Sept 19, 2005. See the total lead content, wt. % for "inside-black."
16. U.S. Consumer Product Safety Commission. Test methodology for accessible lead in vinyl products. Accessed July 10, 2007.
17. CEH FOIA documents. Laboratory report for product: Spiderman lunch boxes, Sample number 05-840-7337. Sept 19, 2005. See the "lead migration to wipe, "µg/100cm2" column and associated note, which provides the average amount of lead over 4 swipes per wipe.
18. CEH FOIA documents. Compare the previous footnote to Laboratory Compliance Summary, Sample number 05-840-7337. Oct 11, 2005. Wipe analysis of lunch boxes is now reported as "µg lead/100cm2 per wipe," and the values are significantly lower than the averages per wipe noted in the previous document (due to being averaged over 30 wipes).
19. CEH FOIA documents. Laboratory continuation for sample number 05-830-4008. Sept 29, 2005.
20. US CPSC. Test methodology.
21. CEH FOIA documents. Laboratory continuation for sample number 05-830-4008. Sept 29, 2005. See "Wipe analysis of lunch boxes". The average value of 0.565 µg was the only value from this test reported later, as can be seen in document: Laboratory compliance summary for sample number 05-830-4008. Oct 11, 2005. See "Wipe analysis of lunch box" for "back purple plastic".
22. CEH FOIA documents. Email summarizing test results. Sept 26, 2006.
23. U.S. Consumer Product Safety Commission (US CPSC). CPSC Corrects Record on Vinyl Lunchboxes. Feb 20, 2007. Accessed July 12, 2007.
24. CEH. Consumer Protection Agency Covered Up Risks from Lead in Children's Lunchboxes.
25. Vinyl News Service. Government Reaffirms Safety of Vinyl Lunchboxes. Feb 22, 2007. Accessed Feb 27, 2007
26. U.S. CPSC. CPSC Corrects Record on Vinyl Lunchboxes.
27. U.S. FDA. Letter to Manufacturers and Suppliers Concerning the Presence of Lead in Soft Vinyl Lunchboxes.
28. Webpage of Congressman Ed Markey. E&C Dems Question CPSC/FDA about High Lead Levels in Lunch Boxes. Feb 22, 2007. Accessed July 12, 2007.
29. U.S. House of Representatives Committee on Energy and Commerce. Letter to the Acting Chairman of CPSC and the FDA Commissioner regarding lead detection in vinyl lunchboxes. Feb 22, 2007. Accessed July 12, 2007. 30. Webpage of Congressman Ed Markey