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Proposed Regulations Relative to Lead in Toy Jewelry in Massachusetts. Public Health Council September 12, 2007 Suzanne K. Condon Director, Bureau of Environmental Health Massachusetts Department of Public Health. Outline. Background Public health significance of lead exposure to children

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proposed regulations relative to lead in toy jewelry in massachusetts

Proposed Regulations Relative to Lead in Toy Jewelry in Massachusetts

Public Health Council

September 12, 2007

Suzanne K. Condon

Director, Bureau of Environmental Health

Massachusetts Department of Public Health

  • Background
    • Public health significance of lead exposure to children
    • CPSC efforts to date
  • MDPH/BEH Toy Jewelry Sampling Effort
    • Sampling
    • Evaluation
    • Results
  • Proposed MA Regulation
  • Conclusions
  • Q & A
background effects of lead on children
BackgroundEffects of Lead on Children
  • Children are more vulnerable than adults to the toxic effects of lead.
  • At lower doses, cognitive and behavioral development is impaired.
  • At higher doses, anemia, kidney damage, brain damage, colic and death can occur.
  • Damage suffered from lead poisoning is rarely reversible.
  • Wide consensus in the scientific community that BLL >10µg/dL is a level of concern.
u s consumer product safety commission cpsc recall
U.S. Consumer Product Safety Commission (CPSC) Recall
  • July 2004: Consumer Products Safety Commission issued voluntary recall on toy jewelry sold in vending machines.
  • BEH was already conducting sampling and analyses of jewelry in vending machines.
  • Despite recall, jewelry in vending machines collected by MDPH contained higher than acceptable levels of lead after the recall.
mdph actions
MDPH Actions
  • Retailers where leaded jewelry was found by BEH/MDPH were notified in writing of the recall and hazards to children.
  • The retailers housing such vending machines removed items from their property.
  • CPSC has issued several more recalls since that time, including jewelry sold in retail stores and targeted for young children.
mdph beh current sampling and analyses efforts winter spring 2007
MDPH/BEH Current Sampling and Analyses Efforts: Winter/Spring 2007
  • 79 Samples collected by BEH staff statewide
laboratory analysis
Laboratory Analysis
  • BEH staff coordinated efforts with MDPH Bureau of Laboratory Sciences (BLS) to use CPSC’s Acid Extraction Test to determine accessible lead content of each sample.
  • CPSC Acid Extraction Test
    • Designed to simulate action of gastric acids on a piece of swallowed toy jewelry.
    • Accessible lead is then considered to be available for absorption into circulatory system.
cpsc s exposure criteria
CPSC’s Exposure Criteria
  • CPSC had previously devised guidance that exposure to greater than 15µg of lead per day over 15 to 30 days could result in elevated BLL (>10 µg/dL) in young children.
  • MDPH believes this exposure period is reasonable for a scenario of swallowing a jewelry item as there have been documented cases where jewelry items remained in children for up to 21 days.
  • More recently, CPSC devised new guidance of 175 µg based on the assumption that exposure to jewelry is a one-time exposure. However this criterion does not take into account the more likely scenario of items staying in a child’s stomach for much longer periods of time.
  • More than one in ten samples contained detectible lead
    • All exceeded CPSC’s previous exposure criterion of 15 µg/day.
    • 8 of 9 samples exceeded current CPSC exposure criterion of 175µg.
    • MDPH also used an EPA pharmacokinetic model (IEUBK) to predict blood lead levels given environmental exposures; 8 of 9 samples were predicted by the model to contain enough lead to raise a child’s blood lead level above 10 µg/dL.
results continued
Results (continued)
  • Communities and locations with jewelry containing detectable lead

- 99¢ Country, Brockton - Big Lots, Lynn

- iParty, Springfield (Chicopee) - Estrella Market, Lawrence

- Hei Elvis Dollar Store, Lowell - Casa Ortiz, Chelsea

- Dollar Fun, Fall River

  • All are Massachusetts high-risk communities (of which there is a total of 14 statewide).
    • High risk communities are those with charachteristics that put children at high risk for lead exposure
      • Low income
      • Older housing stock
      • Elevated blood lead incidence rate above the state rate
      • Percent children screened
proposed criteria for ma standards
Proposed Criteria for MA Standards
  • 0.06% (or 600 ppm) Total Lead Content by Weight
    • Method: CPSC’s Screening Test for Total Lead Analysis
  • 15µg/day Accessible Lead
    • Method: U.S. CPSC Acid Extraction Test
why both standards
Why Both Standards?
  • Available CPSC data show that many samples <600ppm had accessible lead levels that could result in elevated BLL.
  • Analysis of CPSC data
    • Of 108 samples with <600ppm total lead content, ~40% exceeded 15µg/day of accessible lead level.
    • Limited testing of jewelry with high total lead content showed exponentially higher accessible lead levels when the 6 hour acid extraction test was extended to 1-7 days.
  • In order to minimize lead exposures, both test methods are recommended.
  • BEH recommends the 15 µg/day standard instead of the 175 µg standard because we believe it is both more protective and realistic in terms of children’s play habits and exposures.
proposed regulation
Proposed Regulation
  • Toy leaded jewelry means jewelry marketed to or intended for use by children that contains a concentration of lead that has more than 600 ppm total lead content as determined by CPSC’s Screening Test for Total Lead Analysis, or would expose a child to greater than 15ug of lead per day over a chronic exposure period as determined by CPSC’s Acid Extraction Test.
proposed regulation continued
Proposed Regulation (continued )
  • Toy leaded jewelry is jewelry manufactured, shipped or sold at retail or wholesale, indoors or outdoors, over the internet or through catalogs, and includes but is not limited to jewelry 1) sold in: (a) vending machines (b) toy stores or (c) toy displays, toy departments or toy sections, or (2) that may use images or otherwise be designed or packaged to be especially attractive to children.
proposed enforcement plan
Proposed Enforcement Plan
  • BEH has developed a plan for routine spot testing of toy jewelry throughout the state.
  • Regular monitoring will rely on inspection staff collecting a certain number of samples monthly for at least one year after promulgation.
  • Monitoring will be targeted at high risk communities but will also include all communities statewide.
possible penalties
Possible Penalties
  • Hazardous Substances or Consumer Protection statutes apply
  • Once MDPH determines violation, investigation results will be transmitted to Attorney General's office
  • Monetary penalties can be up to $5,000 (under Consumer Protection Act) for each article of banned jewelry sold
  • Imprisonment up to one year is possible (under Hazardous Substances statute) if on at least two separate occasions, a retailer/ distributor/ manufacturer sells banned product in MA.
plans for notification
Plans for Notification
  • MPDH will continue to work with industry groups to notify retailers throughout the state (e.g., via industry newsletters).
  • MDPH will provide technical assistance to retailers on determining safety of children's jewelry.
    • For example, guidance on required documentation demonstrating requisite testing methodologies and results for items to be sold by the retailer.
  • While the CPSC 2004 recall has had a degree of success, toy jewelry containing lead is still present in Massachusetts and poses a hazard to children who are exposed to it.
  • Based upon points of sale evaluated, Massachusetts children living in high risk communities are the children most likely to be exposed to these jewelry products.