Lead Exclusion Request Process Renee Kalmes, MSPH, CIH ICPHSO Annual Meeting and Training Symposium ABA Law Seminar Washington D.C. February 18, 2010

What Congress Did By strict definition of Section 101, numerous materials and components used in children’s products were technically non- compliant By strict definition of Section 101, numerous materials and components used in children’s products were technically non- compliant

CPSIA Section 101(b) Exclusion from Lead Limits A specific product or material could be excluded from lead content limits provided material “will not result in the absorption of any lead into the human body, taking into account normal and reasonably foreseeable use and abuse of such product by a child” A specific product or material could be excluded from lead content limits provided material “will not result in the absorption of any lead into the human body, taking into account normal and reasonably foreseeable use and abuse of such product by a child” To date CPSC has not accepted a broader interpretation of language such as “meaningful absorption” or exposure that results in “measurable increase on child’s blood lead level” To date CPSC has not accepted a broader interpretation of language such as “meaningful absorption” or exposure that results in “measurable increase on child’s blood lead level” To date CPSC has applied little flexibility in granting exclusions To date CPSC has applied little flexibility in granting exclusions

Basic Scientific Principles Hazard/Risk = Exposure x Toxicity Potential contact with product and absorption of lead (“dose”) Discernable impacts on blood lead level

Exposure: What does the science tell us? Product and Hand Wipes Product Type Lead Content (ppm) Product Wipe (µg/wipe) Finger Wipe (µg/wipe) Metal Rubber/plastic Paint on containers1, Plated metal5,600<0.1

Exposure: What does the science tell us? Leaching Tests Material Total Lead Content (ppm) Acid Extraction (ug) Saline Extraction (ug) Metal jewelry components <60020 (avg)15.6 (avg) Metal jewelry components < (avg)4.5 (avg) Plastic charm (avg)1.7 (avg) Crystal beads and rhinestones > 600 to 23, (avg)0.27 (avg)

Exposure: What does the science tell us? Some CPSIA strictly “compliant” materials result in greater amounts of extracted lead than “non-compliant” materials Some CPSIA strictly “compliant” materials result in greater amounts of extracted lead than “non-compliant” materials Dependent on type of testing, it is likely that some amount of lead can be detected in extraction tests or product or hand wipe sampling. However, the amount detected does NOT equate to absorption of lead in body Dependent on type of testing, it is likely that some amount of lead can be detected in extraction tests or product or hand wipe sampling. However, the amount detected does NOT equate to absorption of lead in body

Toxicity of Lead: Measured in Blood Lead Levels Note: NHANES (2003–2006) report mean blood lead level of 1.6 ug/dL for young children 1–5 years.. Source: Needham, The NHANES Second National Report on Human Exposure to Environmental chemicals. CDC. NHANES

How do some denied petition products compare? Intake “Dose” (ug/day) FDA estimate from food and water ~3 ug/day FDA estimate from food and water ~3 ug/day FDA candy ug/day FDA candy ug/day < ug/day estimates from CPSIA petitions < ug/day estimates from CPSIA petitions Blood Lead Effect (ug/dl) Background population 1-2 ug/dl Background population 1-2 ug/dl “ no meaningful exposure and does not pose a health risk” “ no meaningful exposure and does not pose a health risk” <0.2 ug/dl <0.2 ug/dl

Assessment of Impact to Blood Lead Levels Blood Lead Level (µg/dl) Maximum predicted additions of blood lead level from exposure to lead in denied petition products Background Analytically sensitively below 2 ug/dl is poor

To date CPSC denied petitions for products that result in intakes that are not “0” but are: Within “background population” blood lead levels Within “background population” blood lead levels Not discernable using blood lead modeling Not discernable using blood lead modeling Not able to be accurately measured in blood Not able to be accurately measured in blood

Where do we go from here? Use scientific principles that meet Congressional intent Use scientific principles that meet Congressional intent –De minimus –Negligible exposure –No discernable change in blood lead level The issues of negligible risk is not a new principle to Congress The issues of negligible risk is not a new principle to Congress