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# Risk assessment to evaluate if crayons complying with the consumer product safety improvement act of 2008 for lead, also comply with california proposition 65

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## Introduction

The purpose of the legislation of the California Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was to protect the citizens and the drinking water of California state and to inform citizens about chemicals, which are associated with reproductive disorders, birth defects, and cancer. The part of statute states that “ no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state (California) to cause cancer or reproductive toxicity without first giving a clear and reasonable warning…” ( 1 ).

There has been a constant effort to reduce the exposure to lead ( 5 ). Although much progress has been made, there is need to further minimize the exposure to ensure safety for consumers ( 20 ). Since crayons are among the most widely used products by children and can potentially be contaminated with lead, their formulations have to comply with both the Consumer Product Safety Improvement Act (CPSIA) of 2008 as well as California Proposition 65. According to Consumer Product Safety Commission (CPSC) guidelines, the amount of lead in accessible parts of the products used by children cannot be more than 100 ppm ( 21 ). The purpose of this article was to evaluate if crayons complying with the CPSIA of 2008 for lead, also comply with California Proposition 65.

## Methods and Results

We based our assessment on assumption that a child ingests 14 g of crayon material per month from a package of 12 crayons. Using this assumption, we assessed the risk of exposure to a child in terms of average exposure per day over entire lifetime and compared this with the guidelines set by CPSIA and Prop 65. We made another assumption that a child will play with crayons for a period of 3 years (from 3 to 6 years of age) during his/her expected life expectancy of 70 years. Since products used by children cannot have more than 100 ppm lead, we used 99 ppm (i. e., <100 ppm) as acceptable level for our calculations.

1 ppm = 1 mg of something per kilograms (mg/kg or mg/1, 000 g). Therefore, we can calculate that at the concentration of 99 ppm of lead in crayons, how much lead a child could ingest from 14 g of crayons over the period of 30 days:

Over the period of 3 years (or 36 months), this amount will become:

$1 , 386 × 36 = 49 , 896 μg$

When equalized over the life expectancy of 70 years, the daily exposure among children playing with the crayons is calculated to be:

$49 , 896 / 70 = 712. 8 μg / year$

From this, we can calculate exposure per day:

$712. 8 / 365 = 1. 95 μg / day ( approximately ).$

This level is ~8-fold less than a no-significant-risk-level for carcinogens (15 μg/day; oral) and ~4-fold more than a maximum allowable dose level for reproductive toxins (0. 5 μg/day), established by the State of California.

## Conclusion and Recommendations

Based on the assumptions described above, we conclude that the crayons containing 99 ppm of lead, a level at which the crayons comply with the CPSC regulation under the CPSIA, will require labeling under the California Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, as a reproductive toxin. Lead is a toxic heavy metal and poses serious health risks including abnormalities of male and female reproductive systems ( 4 7 ), neurological disorders ( 4 , 8 ), DNA damage, and chromosomal abnormalities ( 9 , 10 ) leading to carcinogenesis ( 3 , 4 ). To minimize the risk to children, the CPSC may also consider further lowering the permissible level of lead in products for children. To produce safer products for children, manufacturers should also lower the level of lead in crayons. Moreover, to minimize the risk of law suits under California Prop 65, manufacturers and distributors should also test their crayons for lead to assure compliance to California Prop 65. California’s Prop 65 has a “ citizen lawsuit” provision that encourages private citizens to file lawsuits against businesses they claim are not fully complying with the law—regardless of whether or not that is true.

## Author Contributions

GA identified the problem and contributed in preparation of manuscript; SK assisted in scientific explanation of the problem, highlighted mechanisms involved in associated health risks, and contributed in manuscript preparation; DA provided critical toxicological expertise and assisted in critical evaluation of problem and manuscript preparation; MS supervised the process, integrated and analyzed information, and prepared the manuscript.

## Conflict of Interest Statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

## References

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