# AmericanAcademy ofPediatrics
DEDICATED TO THE HEALTH Of' IILL CHILDHEN'

AAP Headquarters 141 Northwest Point Blvd Elk Grove Village, IL 60007-1019 Phone: 847/434-4000 Fax: 847/434-8000 E-mail: kidsdocs@aap,org www,aap.org Reply to Department of Federal Affairs Homer Building, Suite400 N 601 131h SI NW Washington, DC 20005 Phone: 202/347-8600 Fax: 202/393-6137 E-mail: kids1sl@aap,org

Executive Committee President 0, Marion Burton, MD, FAAP President-Elect Robert W Block. MD, FAAP Immediate Past President Judith S, Paijrey, MD, FAAP Executive Director/CEO Errol R. Alden, MD, FAAP
Board of Directors District I Carole E, Allen, MD. FAAP Arlington, MA District II Henry A. Schaeffer, MD, FAAP Brooklyn. NY District ill Sandra Gibson Hassink, MD, FAAP Wilmington. DE District IV Francis E, Rushton, Jr, MD, FAAP Beaufort, SC DistrictV Marilyn J. Bull. MD. FAAP Indianapolis, IN DistrictVI Michael V, Severson, MD, FAAP Brainerd, MN DistrictVII Kenneth E, Matthews, MD, FAAP College Station, TX DistrictVIII Mary P Brown, MD, FAAP Bend, OR District IX MyleS B, Abbott, MD, FAAP Berkeley, CA OistrictX John S, Curran. MD. FAAP Tampa, FL March 24, 2011 The Honorable Nancy Nord Commissioner U.S. Consumer Product Safety Commission 4330 East West Highway Bethesda, MD 20814
Dear CommissionerNord: Thank you for this opportunity to respond to your questions following my testimony on behalfofthe American Academy ofPediatrics (AAP) on February 16,2011 atthe Consumer Product Safety Commission (CPSC) hearing, "Children's Products ContainingLead: Technological Feasibility of 100ppm for Lead Content." 

### 1. You quotedstudies that estimatedannual cost of leadpoisoning inAmerican children at$43.4

### billion. Andthatany time average bloodleadlevels increase by 1microgramperdeciliter across children born in anygivenyear, $7.5 billion is lost inpotentialearningsfor those children. Where didyougetyour data? Please submitallof the studiesyou reference so staff can review them. Attached is a version ofmy testimony with all sources cited. 

### 2. You state that fora majority of children, ingestion of an item containing 300 ppm of leadwouldresult in the loss of almost 4

### IQpointsandingestion of an object containing 100ppm wouldresult in the loss of just over 1IQpoints. Please submitstudies usedto arrive at these conclusions. Again, the attached copy ofmy testimony contains references to all ofthe studies. 

### Jhave also attached a copy ofa January 2009 letter provided to Senate Commerce Committee Chairman John Rockefeller explaining in detail the development ofthe AAP's recommendation to limit lead in children'sproducts to 40 parts per million (ppm). 

### 3. Didthe studiesyou reference relating to the loss of IQpointsdue to 

### ingestion of leadbase their findings on exposure justto children'sproducts orwere they basedon exposure to leadfoundin general useproducts, housing andthe environment?
In general, the studies refer to ingestion oflead regardless ofthe source. Once 

### it has been absorbed into the bloodstream, lead does not behave differently in the body based upon the source ofexposure.

### 4. Were the calculations on the effectsof leadingestion basedon the assumption the item gets swallowedbythe child? Do allmaterials actthe same waywhen ingested? Calculations are based on the assumption that an item or some portion ofit (including a part, piece, chip, orresidue) is ingested. As stated above, lead does not behave differently in the body based upon the source ofexposure. The composition ofthe item ingested may, however, contribute to the degree ofexposure. The amount oflead that enters the bloodstream may variously depend upon the size or amount ofthe material ingested, its form, and other factors. Forexample, some items may pass through the digestivetract relatively rapidly, while others could remain in the stomach for very long periods oftime. 

### 5. Does swallowing behavior change as children mature? Would,for example, the spokes of a bike ora brass drawerpullpresent the same riskas an infantrattle or toddlerpulltoy?
In general, mouthing or swallowing behaviors decrease as children age. Mouthing and swallowing tend to peak in the toddler years and steadily decrease throughout school age. A review ofreports that describe children's mouthing was published by the U.S. Environmental Protection Agency in 2009. 1 The EPA report has a significant quantity of similardata, with frequency oforal behaviors and minutes/day ofmouthing. The amount oflead that would be transferred to a child may depend on mouthing behavior (times/hour and minutes/day) and thetransfer rate oflead from the objectto the hand (if the object is touched and not directly mouthed). Children as old as 10·12 years put

### their hand in their mouth an average of4 times hourly. This rate is much higher among younger children, and exposures from mouthing behaviors can be occurring for several hours daily per child. Even for adult workers, hand lead is associated with blood lead level? 

### 6. You suggest the Commissionshoulduse theflexibility grantedby Congress under CPSIA. Canyoupleaseprovide some specific examples of how we shouldapply this flexibility. For example shouldthe Commission use its discretion to lookat technological ftasibility for that categoryof products that are likely to be ingested? The Consumer Product Safety Improvement Act give the CPSC the discretion to grant exemptions from the 100ppm lead limit in cases where the limit is determined to be not "technologically feasible." The limit is deemed technologically feasible for a product or product category in the statute if: (l) a productthat complies with the limit is commercially available in the product category; (2) technology to comply with the limit is commercially available to manufacturers or is otherwise available within the common meaning ofthe term; (3) industrial strategies or devices have been developed that are capable or will be capable ofachieving such a limit by the effectivedate ofthe limit and that companies, acting in good faith, are generally capable ofadopting; or(4) alternative practices, best practices, or other operational changes would allow the manufacturer to comply with the limit.
The conference report further notes: 

### The Coriference Report ultimately requires that the Commission lower thepermissible leadlevel in children'sproducts to the lowest amount that is technologically feasible. This sectionprovides a definition of technologically feasible, andincludes aprovision identifyingalternativepractices. bestpractices, orotheroperational changes thatwould allow a manufacturer to complywith the leadlimit. The intent of this alternative andbest practicesprovision is to require manufacturers to use bettermethods of producinga product that can be achievedwithout the need formajortechnologicaladvances. such as takingsteps to better clean equipment orthe factory, orto make changes in operation, maintenance, orotherpractices thatcan reduce oreliminate leadin theproduct.3
The statute's carefully-crafted definition oftechnological feasibility does not make allowance for the introduction ofrisk assessment as a factor in making these determinations. In fact, 

### it may be inferred from its exclusion that the intent ofCongress was specifically to rule out the use ofthese factors. If, however, a product contains lead and the CPSC determines that the parameters above cannot be met, then that product warrants strong consideration for an exemption from the lOOppm limit.
Again, thankyou for this opportunity to respond to your questions. Ifthe American Academy ofPediatrics or I may be offurther assistance, please contact Cindy Pellegrini in the AAP's Washington, DC office at 202/347-8600. Sincerely,

/ ' J DanaBest, MD MPH FAAP

I U.S. Environmental Protection Agency. Child-Specific Exposure Factors Handbook. August 2009, (EPA/600/R-08/135). 2 Rodrigues E, Virji M, McClean M, Weinberg J, Woskie S, Pepper L Personal exposure, behavior, and work site conditions as determinants ofblood lead among bridgepainters. J Occup Environ Hyg, 2010 Feb;7(2):80-7. 3 Conference report 110-787, to accompany H.R. 4040, the Consumer Product Safety Improvement Act of 2008,

# Anlerican 

# AcadetTIv ofPediatrics .I

DEDICATr:o TO 'T'HL HEALTH CH: ALL UIIU)RI'0:



### Wednesday, February 16, 2011 Testimonyof Dana Best, MD, MPH, FAAP



### On behalfofthe American Academy ofPediatrics



### Beforethe ConsumerProductSafetyCommission "Children's Products ContainingLead: Technological Feasibilityof 100ppmfor Lead Content"

American Academy of Pediatrics • Departmentof Federal Affairs 60113th Street NW, Suite 400 North • Washington, DC 20005 Tel: 800.336.5475 • E-mail: kidslst@aap.orgDana Best, MD, MPH, FAAP American Academy of Pediatrics Children's Products Containing Lead: Technological Feasibility of lOOppm for Lead Content February 16, 2011

Chairman Tenenbaum and CommissionersAdler, Moore, Nord and Northup, thankyou for this opportunity to speakto you today. My name is DanaBest, MD, MPH, FAAP, and I am pleased to representthe American Academy ofPediatrics (AAP), a non-profit professional organization of60,000 primary care pediatricians, pediatric medical sub-specialists, and pediatric surgical specialists dedicated to the health, safety, and well-being ofinfants, children, adolescents, and young adults. I am an Associate Professor ofPediatrics at George Washington University School ofMedicine and an attending physician at Children'sNational Medical Center in Washington, D.C. I served for six years on the AAP's Committee on Environmental Health, which is the primary body within the AAP that handles lead and other environmental health issues.
Underthe ConsumerProduct Safety Improvement Act of2008 (CPSIA), the ConsumerProduct Safety Commission (CPSC) is directed to reduce to 100 parts per million (ppm) the allowablc levels oflead in children's products in August2011, "unless the Commission determines that a limit of 100 parts per million is not technologically feasible for a product or product category." TheAAP appreciates the Commission's diligence in seeking public input about the public health and other impacts ofreducing the permissible lead levels to 100ppm.
The Commission has undoubtedly received and reviewed a tremendous amount ofmaterial about the research behind lead exposure and its impact onchild health. I will therefore give only a briefoverview ofthe state ofthe science. 

### LeadIs aKnown Neurotoxin Lead has been recognized as a potent neurotoxin since the time ofthe Roman empire, although the mechanisms by which it inflicts brain damage have only been explored and understood in the past century. The brain damage caused by lead exposure is permanent and irreversible. Few options exist for treating lead exposure at high levels, and these treatments have potentially dangerous side effects. No options exist for treating lead exposure at low to moderate levels. Exposure to lead is amply documented to cause the loss ofintellectual capacity. On average, children whose blood lead levels (BLLs) rise from 10 to 20 micrograms per deciliter (mcg/dL) lose two to three IQ points. More recent studies have shown an even greater impact on lQ of BLLs under 10 mcg/dL. Key studies reported a loss of4 to 7 IQ points in children whose lead 2 levels rose from 1mcg/dL to 10 mcgJdL. 1• These studies suggestthat "low" levels ofexposure

- meaning BLLs less than 10 mcg/dL cause proportionately greater harm than higher levels.
In addition to these impacts on IQ, lead exposurehas documented effects on behavior, with higher rates ofbehavioral problems reported in young children, teens and adults exposed to lead during childhood. Investigators have identified associations between lead exposure and increased aggression, commission ofcrime and antisocial or delinquent behaviors?,4,5,6 Children with elevated lead are more likely to have problems with attention deficit, reading disabilities, and to fail to graduate from high school. Other effects include abnormal balance, poor eye-hand 8 coordination, longer reaction times, and sleep disturbances.7• ,9

Page 2 of6Dana Best, MD, MPH, FAAP American Academy of Pediatrics Children's Products Containing Lead: Technological Feasibility of 100ppmfor Lead Content February 16, 2011

With all ofthis information in mind, it is critically important to note that lead is bioaccumulative. A percentageoflead will be excreted by the body, and the rate ofclearance is dependent on a number offactors, including nutritional status. But a percentage oflead is also stored in the body, primarily in bone. These body stores can persist over decades. When a woman becomes pregnant, her body draws upon its calcium storesto create her fetus's bone structure. Iflead has been stored in the bone, the developing fetus will be exposed to doses oflead at points throughout pregnancy. 10 Further, a women's blood lead in pregnancy puts her at higher risk for complications from high blood pressure. A recent study in Environmental Health Perspectives found blood pressureto be about 4-6 mmHg higher in women giving birth to infants with a cord blood lead level of 1-6 mcg/dL versus cord blood levels of:::;0.46 mcg/dL.11
Thecosts associated with lead exposure are tremendous. Health economists estimatethat every time average blood lead level increases by a small amount" across the children born in any given year, $7.5 billion is lost in potential earnings for those children.12 Other studies have estimated the annual cost oflead poisoning in American children at $43.4 billion. 13 Costs are borne by ollr health care, education, andjustice systems, among others. Lead is naturally present in ourenvironment at low levels. Human activities have raised those levels through contamination, whether by adding lead actively to products like paintorgasoline or producing it as a byproduct ofactivities like burning coal. Lead is present at low levels in our air, soil, and water, but often very difficult to remediate in those cases. It is therefore critical to restrict lead exposure in environments directly under our control, such as consumer products. 

### AAP'sRole in the CPSIA During the development ofthe CPSIA, the AAPwas asked by Congress to recommend a limit for permissible levels oflead in children's products. The Academy engaged in a rigorous scientific process involving a review ofthepertinent literature and ultimately recommended that lead be limited to 40ppm. AAP pediatric environmental health experts determined that, based on the most up-to-date science, an object with 77ppm lead would be capable ofraising a child's blood lead level to a level that would result in the loss ofone IQ point. Recognizing that most children are exposed to other sources oflead and that it is bioaccumulative, the AAP recommended a twofold margin ofsafety and reduced the recommendation from 77to 40ppm. The level of40ppm was also selected to fall above the naturally-occurring background levels of lead seen in various parts ofthe United States. 14
The AAP worked closely with Congressthroughout the development ofthe CPSIA to provide access to pediatric environmental health experts and researchers, who consulted on various aspects ofthe legislation. The final bill represented a significant step toward reducing children's

• "Small amount" is defined here as I mcg/dL increase in blood lead level.

Page 3 of6Dana Best, MD, MPH, FAAP American Academy of Pediatrics Children's Products Containing Lead: Technological Feasibility of 100ppm for Lead Content February 16, 2011

exposure to lead, particularly by setting limits where none had previously existed on materials other than surface coatings in children's products. 

### Health Effects of ReducingLeadLimits(rom 300to 100ppm
In the January 26 

### FederalRegister notice, "Children's Products Containing Lead; Technological Feasibility of 100 ppm for Lead Content,"the CPSC requested public comment on several specific questions. TheAAP would like to provide information on#6: "What health effects are associated with a reduction ofthe lead content limit from 300 ppm to 100 ppm? From 300 ppm to some other level above 100 ppm?" Based on theAAP's previously-noted calculations, an object containing 77ppm of/ead is capable ofraising a child's blood lead level to a level that would result in the loss ofone IQ point. Please note thatthis is not meant to be interpreted as a definitive statement for each exposed individual; rather, it is a public health statement representing what will be true for the majority ofchildren. Individual children will have factors that either increase or decrease their vulnerability.
Forthe majority ofchildren, ingestion ofan item containing 300ppm oflead would result in the loss ofalmost 4 (3.9) lQ points. Ingestion ofan object containing 100ppm lead would result in the loss of justover one (1.3) IQ points. When averaged across even a modest population ofchildren, the public health harm caused by lead is significant. Considering that there are about 75 million children in our nation, impacting one-halfofone percent ofall children would mean exposure of3.75 million children. Respected economic studies estimatethe loss oflifetime income at $8,346 (1995 dollars) for each loss of one IQ point. For 10,000 children, this equals approximately $83.4 million; for 100,000 children, it would be $834 million. Foronemillion children, it would total over $8.3 

### billion. OtherImportantIssuesRelatedto LeadExposure The Commission has received numerous comments regarding the feasibility ofreducing permissible lead levels from 300 to 100ppm. With those in mind, the AAP would urge the Commission to keep some additional points in mind. 

### Children mustbeprotected/rom both acute andchronic exposure to lead. Cases where exposure to a single lead-laden object can cause severe or fatal lead poisoning are, happily, rare. The CPSIA focused on preventing the often-invisible but pernicious cases ofsilent lead poisoning, where parents or caregivers are unaware that lead exposure everoccurs. The Commission must remember that lead accumulates in the body and exposure can come from mUltiple sources, so exposure must be limited as much as possible from each individual pmciuct to avoid accumulation to dangerous levels.

Page 4 of6Dana Best, MD, MPH, FAAP American Academy of Pediatrics Children's Products Containing Lead: Technological Feasibility of 100ppmfor Lead Content February 16, 2011 

### Harmfrom leadis usually invisible. Mostchildren are tested either once ortwice for lead exposure, either around the ages ofone ortwo years, or both. Exposures in infancy will not be detected until at least age one, and those thattake place afterthe age oftwo years may never be detected. In some communities where the risk oflead poisoning from older housing stock is deemed low, testing for blood lead levels may not be performed at all. As a result, parents may never be aware oftheir child's elevated blood lead level or associated damage. Moreover, there is no way for parents to know ifa given object contains lead, so they are powerless to control exposure orprotect theirchildren. It is the responsibility ofthe Commission to provide that protection for children and families. 

### Riskassessmentof individualproducts orclasses of productsis impracticalandsubjective. Some have recommended thatthe CPSC engage in some form ofrisk assessmentto determine the levels oflead permitted in children's products. From a medical perspective, the benefit of lead exposure is zero, and so the considerable risk will always outweigh the benefit ofhm'ing lead in children's products. A risk assessment scheme would introducetremendous levels of SUbjectivity into this process and remove any certainty for parents and caregivers aboutthe safety ofthe items they purchase. In addition, the CPSC would shoulder an untenable burden in attempting to perform or confirm risk assessment on various products. For all ofthese reasons, the AAP urges you to reject calls for risk assessment related to individual products and the amount oflead that should be permitted in them. 

### Leadlimitsshouldbe basedon total, ratherthan accessible, leadlevels. Congressthoroughly explored the issues related to accessible versus total lead and issued a clear statutory direction for the agency to regulate based on total lead. The variability among laboratory tests for acc(,ssible lead and the fact that accessibility can change over time (e.g. as certain materials degrade) ted Congressto reject accessibility as the appropriate standard for regulation. In fact, Congress directed the CPSC to use total lead as a way to provide greater certainty and consistency, making it easier for companies to measure compliance reliably. Challenges with consistency among tests performed by laboratories should lead the CPSC to work more closely with those entities to ensure the appropriateness and consistency ofprotocols used. Laboratory issues do not, however, negate the validity ofIOOppm as the appropriate standard protective ofchild health. 

### CPSCshouldcollaborate closely with companies workingto comply in good faith. The AAP appreciates that both the Commission and individual companies will undoubtedly face challenges related to compliance. In particular, very small producers may face difficulties related to the cost or complexity oftesting. The AAP urges the CPSC to work closely with these entities to craft creative, flexible solutions that reduce the regulatory burden while also preserving child health and safety.
In conclusion, I appreciate this opportunity to offercomments on behalfofthe American Academy ofPediatrics. The AAP urges the Commission to continue placing the highest priority on protecting children from lead exposure and its devastating consequences. Large number of children's products currently on the market already comply with lead limits; we encourage you

Page 5 of6Dana Best, MD, MPH, FAAP American Academy of Pediatrics Children's Products Containing Lead: Technological Feasibility of 100ppm for Lean Content February 16, 2011

to work closely with those remaining companieswho still face compliance challenges to identify solutions. In any small number ofcases where the CPSC may determine that the lOOppm limit is not technologically feasible, the CPSC should use the flexibility granted by Congress under the CPSIA. The AAP stands ready to assistyou in any way in this important undertaking. Please do not hesitate to call upon us.

I Canfield RL, Henderson CR, Jr., Cory-Slechta DA, Cox C, luskoTA, Lanphear BP. Intellectual impairment in children with blood lead concentrations below 10 microg per deciliter. N EnglJ Med. 2003;348(16):1517-1526. 2 Lanphear BP, Hornung R, Khoury J, et al. Low-level environmental lead exposure and children's intellectual function: an international pooled analysis. Environ Health Perspect. lui 2005; 113(7):894-899. 3 Dietrich KN, Ris MD, Succop PA, Berger OG, Bornschein RL. Early exposure to lead andjuvenile delinquency. Neurotoxicol Teratol. Nov-Dec 200I;23(6):511-518.
4 Ris MD, Dietrich KN, Succop PA, Berger OG, Bornschein RL. Early exposure to lead and neuropsychological outcome in adolescence. JIn! NeuropsycholSoc. Feb 2004:261-270. 5Burns 1M, Baghurst PA, Sawyer MG, McMichael Al,Tong SL. Lifetime low-level exposure to environmental lead and children's emotional and behavioral development at ages 11-13 years. The PortPirie Cohort Study.Am.! Epidemiol. Apr 151999;149(8):740-749. 6 Nevin R. Understanding international crime trends: the legacy ofpreschool lead exposure. Environ Res. 2007;104(3):315-336. 7 Centers for Disease Control and Prevention. Managing ElevatedBloodLeadLevelsAmong Young Children: Recommendations/rom theAdvisory Committee on ChildhoodLeadPoisoningPrevention. Atlanta, GA: Centers for Disease Control and Prevention; 2002. 8 BhattacharyaA, Shukla R, Dietrich KN, Bornschein RL. Effect ofearly lead exposure on the maturation of children's postural balance: a longitudinal study. Neurotoxicol Terato!. 2006;28(3):376-385. 9 Chiodo LM, Covington C, Sokol R1, et al. Blood lead levels and specific attention effects in young children. Neurotoxicol Terato!. Apr 21 2007. 10 Schnaas L, Rothenberg SJ, Flores MF, et al. Reduced intellectual development in children with prenatal lead exposure. Environ Health Perspect. 2006;I14(5):791-797. II Wells E, Navas-AdenA, Herbstman l, Apelberg B, Silbergeld E, Caldwell K, Jones R, Halden R, Witter F, Goldman L. Low Level Lead Exposure and Elevations in Blood Pressure During Pregnancy. EnvironHealth Perspect. 2011; doi: 10.1289/ehp.l002666 12 SalkeverD. Updated Estimates ofEarnings Benefits from Reduced Exposure ofChildren to Environmental Lead. EnvironmentalRes. 1995: 70:1-6. 13 Landrigan PJ, Schechter CB, Lipton 1M, Fahs MC, Schwartz J. Environmental pollutants and disease in American children: estimates ofmorbidity, mortality, and costs for lead poisoning, asthma, cancer, and developmental disabilities. Environ Health Perspect2002; 110:721-8. 14 U.S. Geological Survey Professional Paper 1648. Geochemical Landscapes ofthe Conterminous United States NewMap Presentations for 22 Elements. Figure 17. November 2001. Avallable at http;!!pubs.lIs:cs.gov/pp!p16.t8/pI M8.pdf.

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# AmericanAcadenlY ofPediatrics
DEDICATED TO THE HEALTH OF ALL CfllLUIUl"­

AAP Headquarters 141 Northwest Point Blvd Elk Grove Village, IL 60007-1098 Phone: 847/434-4000 Fax: 847/434-8000 E-mail: kidsdocs@aap.org www.aap.org Reply to Department ofFederal Affairs Homer Building, Suite 400 N 601 13th St NW Washington, DC 20005 Phone: 202/347-8600 Fax: 202/393-6137 E-mail: kids1st@aap.org

Executive Committee President David T, Tayloe, Jr, MD, FAAP President-Elect Judith S Palfrey, MD. FAAP Immediate Past President Renee R Jenkins, MD, FAAP Executive Director/CEO Errol R Alden, MD, FAAP Board of Directors District I Edward N. Bailey, MD, FAAP Salem, MA District II HenryA Schaeffer, MD, FAAP Brooklyn, NY District III Sandra Gibson Hassink, MD. FAAP Wilmington, DE District IV Francis E. Rushton, Jr, MD, FAAP Beaufort. SC DistrictV Marilyn J. Bull, MD, FAAP Indianapolis, IN DistrictVI Michael V. Severson, MD, FAAP Brainerd. M N DistrictVII Kenneth E. Matthews. MD, FAAP College Station, TX DistrictVIII Mary P Brown. MD. FAAP Bend, OR District IX Myles B. Abbott. MD. FAAP Berkeley, CA DistrictX John S, Curran. MD, FAAP Tampa. FL January 21,2009 The Honorable John D. Rockefeller IV Chairman Committee on Commerce, Science and Transportation 508 Dirksen Senate Office Building Washington, DC 20510
Dear Chairman Rockefeller: The American AcademyofPediatrics, a non-profit professional organization of60,000 primary care pediatricians, pediatric medical sub-specialists, and pediatric surgical specialists dedicated to the health, safety, and well-being ofinfants, children, adolescents, and young adults, appreciates this opportunity to respond to your inquiry for more details on the development ofourrecommendations for limiting lead content in children's products. 

### LeadandChildren'sHealth There is no "safe" level oflead exposure. The vulnerability ofchildren to lead poisoning during development oftheir brains and nervous system:-; has been amply demonstrated, and the literature is very consistent. On average, children whose blood lead levels (BLLs) rise from 10 to 20 micrograms per deciliter (mcg/dL) lose two to three IQ points. More recent studies have shown an even greater impact on IQ ofBLLs under 10 mcg/dL. Key studies reported a loss of4 to 7 IQ points in children whose lead levels rose from 1mcg/dL 10 10 mcg/dL. 1 ,2 These studies suggestthat "low" levels ofexposure - meaning BLLs less than 10 mcg/dL cause proportionately greaterharm than higher levels. The effects oflead 011 health do not stop once the child's brain and nervous system mature or the BLL falls, A recent study found that in a group of7yearold children who had experienced a BLL of20­ 44 mcg/dL around age 2 years, the concurrent BLL (i.e., BLLtaken at age 7 years when the IQ test was administered), was more closely associated with IQ at age 7 years that BLL at age 2 orage 5 years.3
Another important lasting effectoflead exposure is on behavior, with higher rates of behavioral problems reported in teens and adults exposed to lead during childhood. Children with elevated lead are more likely to have problems with inattention and reading, and are at higher risk offailing to graduate from high schoo\.4 Investigator, have identilicd associations between lead exposure and increased aggression, commission ofcrime and antisocial or delinquent behaviors.5,6,7,8 Studies have suggested that several nations which began reducing lead exposure aggressively in the 1970s experienced corresponding decreases in crime rates two to three decades later.9 Other effects include abnormal balance, poor eye-hand coordination, longer reaction times, and sleep disturbances. 10,1 1,12Lead is easily absorbed by ingestion or inhalation. The most common route ofexposure ofchildren is through ingestion, usually by putting hands and other objects in their mouth". Both hand-to-mouth exploration and playing on floors are typical behaviors for children, especiaIly younger children. Studies using videos to record oral behaviors or young children report hand or object in mouth activities 20 or more times per hour.13,14 If hands orobjects placed in the mouth have lead, these usual childhood activities deliver doses oflead. Once lead enters the body it remains there for years. Lead is similar to calcium from the elemental perspective. This meansthatourbodies "see" lead as calcium, absorb it into blood and then store it in bone. These stores oflead can bereleased years later, when bone changes occur or demands on calcium stores are made.IS Another consequence of storing lead in bone is that exposures separated by months oryears have an additive effect on the body's burden oflead and can exert effects over decades. Acquisition or lead in the body even in small amounts (Le., amounts that result in BLLs less than 10 mcg/dL) contributes to this accumulation oflead. This means that even short term or small cumulative exposures can have lasting negative effects.
Over the past 30 years, average BLL has declined dramatically in the U.S., due largely to the elimination oflead from gasoline and mandated restriction oflead content in paint. Atthe same time, however, elevated BLL is still not uncommon. Eliminating elevated blood lead levels was established as a key goal underthe federal Healthy People 2010 initiative. 16 The AAP believes firmly that our nation must continue efforts to reduce childhood lead exposure and its pernicious impacts. In the pastthree years alone, the AAP has pushed the Environmental Protection Agency to reduce airborne lead emissions underthe National Ambient Air Quality Standards; urged the Food and Drug Administration to eliminate lead in imported candies and their wrappers; and continued our long-term engagement with the Department ofHousing and Urban Developmentto reduce children's exposure to lead paint in older housing and through home renovation activities. We intend to sustain these efforts to ensure that children's potential for exposure to lead is reduced as much as possible and new avenues ofexposure are not created. 

### Leadin Children'sProducts
As you know, prior to the passage ofthe Consumer Product Safety Improvement Act (CPSIA), our government had never set limits for acceptable lead content in children's products, with the exception oflead in surface paint. Therestriction oflead content to 600 parts per million (ppm) dates back to 1978 and does not apply to any other material or component in toys or children's products. As a result, toys and children's products could have unlimited amounts oflead in areas otherthan surface paint without violating any mandatory standard. Further, the 600 ppm limit for paint does not represent a healthbased standard. Lead can find its way into toys and children's products as a naturally-occurring componentofmaterials used or as a deliberate or incidental additive. Lead is used



### 2directly in certain materials, such as to stabilize some vinyl compounds and in lead crystal. Lead may also be a contaminant in air, water or soil thatcomes into contactwith materials orcomponents during the manufacturing process. Regardless ofits source, however, lead'stoxic effect on the developing brain requires us to examine these processes and minimize exposure whenever possible. Because there is no "safe"blood lead level in children, the AAP focused attention on limiting lead to trace amounts that would not represent "added" lead to products. 

### Developmentof theAAP

### LeadRecommendation
In September 2007, the AAP was asked by the House Committee on Energy and Commerce to testify aboutthe hazards oflead and to make specific recommendations for lead contentthat would be used in the development ofproduct safety legislation. While the AAP had published guidelines on lead exposure prevention, detection and management in the past, we had never attempted nor been requested to provide specific targets for lead content in products. The recommendation delivered to Congress was an ancillary effortthat builds upon but is not inconsistent with or contradictory to our previously published statements. The AAP's recommendations were developed by our Committee on Environmental Health (COEH), which comprises 

### 9 top pediatric environmental health experts serving in a volunteer capacity. While child health issues were their guiding principle, the COEH also wentto great lengthsto examine the associated practical issues involved to ensure that the final recommendations would be pragmatic and feasible. The primary considerations were: 1) no "safe"threshold for blood lead levels for children has been identified; 17 2) lead negatively affects health and development at levels well below 10 micrograms per deciliter (mcg/dL) blood lead level;18 and 3) lead is a naturally-occurring element and may therefore be present is a wide array ofmaterials so "lead-free" status may not be achievable in some products. Therefore, children's exposures to lead in products should be severely limited, but some low level ofexposure, a "trace" amount, could be expected.
Theprimary goal ofthe COEH in developing these recommendations was to establish a guideline based directly on child health issues, rather than the selection ofan arbitrary number. After much discussion, the committee agreed that the appropriate benchmark for its recommendation should be the loss of 1IQ point. Using California Office of Environmental Health Hazard Assessment analysis that evaluated the upper 97.5% confidence level ofblood lead level associated with this effect, a 

### 1IQ point loss waul!] be prevented by limiting a child's BLL increase to no more than 

### 1mcg/dL,19 Supporting a rationale on 

### 1mcg/dL rise is the FDA upper limit for lead in food at 6 mcg/lead/day for children aged <6 years, which is expected to cause a child's BLL to rise by 

### 1mcg/dL,20 There is no logical reason to accept a higher rise in blood lead level from product exposure than from food exposure.



### 3The COEH's nexttask was to determine the amount oflead that would result in a child's BLL increasing by 1mcg/dL from exposureto a child's product. Thisevaluation focused on information posted by CPSC evaluations.21 The committee determined as follows:

• Based on the 1999-2000National Health and Nutrition Examination Survey (NHANES), the averageblood lead level ofa child aged 1-5 years in the US in 1999-2000 was 2.2 mcg/dL. • In developing its recommendation for lead in toyjewelry, the CPSC calculated that an extractable lead content of 175 mcg would cause an average child's BLL to rise to 10 mcg/dL over a I month exposure period. The agency determined that this level ofexposure occurs at a level of0.06% lead by weight (600 ppm, coincidentally, the same limit as the 1978 lead paint ban).22 • As noted above, however, the COEH had already determined that waiting for BLL to rise to 10 mcg/dL was not acceptable due to the neurological damage that would occur. In orderto limit the BLL rise to I mcg/dL, the CPSC figures were divided by 7.8, which represents the rise in BLL from 2.2 mcg/dL to 10 mcg/dL, to obtain the figure thatwould correlate to a BLL increase of I mcg/dL. Accordingly, 600 ppm lead divided by 7.8 equals 77 ppm lead being capable of causing a BLL increase of 1mcg/dL.
In its next step, the COEH took into accountthe fact that most children are exposed to lead from a variety ofsources, which may include lead paint hazards in the home, airborne lead emissions, contaminated soil, and other consumer products. Since lead is bioaccumulative and highly persistent in the body, it is importantto provide a margin of safety to ensure that exposure to a single toy or children's product cannot cause BLLto increase 1mcg/dL.
In determining how to setthis margin ofsafety, the COEHexamined the practical issues associated with lead exposure. Lead occurs naturally in the environment, so setting lead content at zero was not deemed to be a feasible recommendation. The committee examined data from a variety ofsources to learn aboutthe natural geological occurrence oflead in the United States. The U.S. Geological Survey provides nationwide data on lead exposure, which illustrates that naturally occurring lead levels**gen~rally** top outat 30 ppm.23 The AAP confirmed this datawith Geological Survey and independent geologists. Given this evidence, the COEH recommended a two-fold margin ofsafety for lead content in children's products, dropping the recommendation from 77 ppm to 40 ppm. You may notethat this is considerably lowerthan the margin ofsafety mandated underother federal laws; for example, the tolerance for pesticide residue on food requires a ten-fold margin ofsafety (i.e., limit set at one tenth ofthe amount estimatedto cause the negative effect) for vulnerable populations, including children. 

### Developmentof the CPSIA 

### StandardandExceptions Clause
Overthe yearthat Congress spent working intensively on this legislation, the AAP engaged in a detailed dialogue with both House and Senate offices regarding the merit of various possible exemptions to the lead guidelines. In partnership with these offices, the

4AAP collaborated on the development oflegislative language that empowers the Consumer Product Safety Commission (CPSC) to accept and evaluate applications for such exemptions. This process will include possible exemption for inaccessible lead, although the definition ofinaccessibility was the subject ofmuch debate. For example, 

### it was questioned whether lead would be considered inaccessible ifit were covered by paint orelectroplating, or included in a compound such as vinyl or lead crystal. In each of these cases, the COEH advised that lead was not inaccessible because barriers like paint and electroplating can be breached, vinyl deteriorates with time and use, and lead leaches from crystal in the presence ofacid (including stomach fluids).
In the final legislation, the CPSC is specifically directed to examine the application ofthe lead standard to electronic products, including batteries, and to develop guidelines for minimizing children's exposureto lead that cannot be eliminated from these products. The AAP supported these proposals, which will allow for the transparent, science-based evaluation ofproposals to permit lead in certain components oftoys and children's products. The AAP anticipates offering our views and guidance to the CPSC as such applications are submitted and examined.

The AAP is acutely aware ofthe impact our recommendations can have, and we strive to ensure that all AAP recommendations are based on science and practical to implement. Led by the COEH, the AAP engaged in a thorough, evidence-driven review to develop our lead recommendations. Followingthat, AAPmembers and staffspent countless hours engaged with numerous Congressional offices to explore the issues associated with lead in children's products and to assist in crafting a final bill that would protect children's health through pragmatic, feasible standards. The AAP strongly supported this legislation and looks forward to working with the Consumer Product Safety Commission on its implementation in the coming years. Ihopethis letter satisfies your request for information and gives you confidencethatthe AAP's recommendations represent an empirically-based solution grounded in science. If the Academy may be offurther assistance, please contact Cindy Pellegrini in our Washington, D.C. Office at 202/347-8600. Sincerely,

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## \. 1\"'"'r: [ i . 

# C:t \' J:

# ~.vt-( .• j !r (" David T. Tayloe, Jr., MD FAAP President

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### 5I Canfield RL, Henderson CR, Jr., Cory-Slechta DA, Cox C, Jusko TA, Lanphear BP. Intellectual impairment in children with blood lead concentrations below 10 microg per deciliter.NEnglJ Med. 2003;348(16): 1 517-1526. 2 LanphearBP, Hornung R, Khoury J, et aI. Low-level environmental lead exposure and children's intellectual function: an international pooled analysis. EnvironHealth Perspect. Jul 2005;113(7):894-899. 3 Chen A, Dietrich KN, Ware JH, Radcliffe J, Rogan WJ. IQ and blood lead from 2 to 7 years ofage: are the effects in older children the residual ofhigh blood lead concentrations in 2-year-olds? Environ Health Perspect. 2005;113(5):597-601. 4 Centers for Disease Control and Prevention. ManagingElevatedBloodLeadLevelsAmong Young Children: Recommendations/rom theAdvisory Committee on ChildhoodLeadPoisoning Prevention. Atlanta, GA: Centers for Disease Control and Prevention.; 2002. 5 Dietrich KN, Ris MD, Succop PA, BergerOG, Bornschein RL. Early exposure to lead andjuvenile delinquency. Neurotoxicol Teratol. Nov-Dec 2001;23(6):511-518. 6 Ris MD, Dietrich KN, Succop PA, Berger OG, Bornschein RL. Early exposure to lead and neuropsychological outcome in adolescence.J inlNeuropsycholSoc. Feb 2004:261-270. 7 Burns JM, Baghurst PA, Sawyer MG, McMichael AJ, Tong SL. Lifetime low-level exposure to environmental lead and children's emotional and behavioral development at ages 11-13 years. The Port Pirie Cohort Study.AmJ Epidemiol. Apr 151999;149(8):740-749. 8 Nevin R. Understanding international crimetrends: the legacy ofpreschool lead exposure. EnvironRes. 2007;104(3):315-336. 9 1bid. 10 Centers for Disease Control and Prevention.lvlanagingElevatedBloodLeadLevelsAmong Young Children. Recommendations/rom the Advisory Committee on ChildhoodLeadPoisoningPrevention. Atlanta, GA: Centers for Disease Control and Prevention; 2002. 11 Bhattacharya A, ShuklaR, Dietrich KN, Bornschein RL. Effect ofearly lead exposure on the maturation of children's postural balance: a longitudinal study.Neurotoxicol Teratol. 2006;28(3):376-385. 12 Chiodo LM, Covington C, Sokol RJ, etat. Blood lead levels and specific attention effects in young children. Neurotoxicol Teratol. Apr 21 2007. ]J Reed KJ, Jimenez M, Freeman NC, Lioy PJ. Quantification ofchildren's hand and mouthing activities through a videotaping methodology.J ExpoAnalEnviron Epidemiol. 1999;9(5):513-520. 14 Ko S, SchaeferPD, Vicario CM, Binns HJ. Relationships ofvideo assessments oftouching and mouthing behaviors during outdoorplay in urban residential yards to parental perceptions ofchild behaviors and blood lead levels. J ExpoSci Environ Epidemiol. 2007; 17(1):47-57. 15 O'Flaherty EJ. A physiologically based kinetic model for lead in children and adults. Environ Health Perspect. 1998;106 SuppI6:1495-1503. 16 Centers for Disease Control and Prevention, Healthy People2010

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..**:':''':';:''=;'-'''''.~''e...,.,:"",-,,_** •**..::~c** 17 Centers for Disease Control and Prevention. PreventingLead Poisoning in Young Children. Atlanta: CDC; 2005. 18 Centers for Disease Control and Prevention. Interpreting and Managing Blood Lead Levels <10 Ilg/dL in Children and Reducing Childhood Exposures to Lead: Recommendations ofCDC's Advisory Committee on Childhood Lead Poisoning Prevention. MkfWR. November2,2007; 56(RR08):l-14;16. 19 Carlisle J, Dowling K. Development ofHealth Criteria for School Site Risk AssessmentPursuantto Health and Safety Code Section 901(g): Child-Specific BenchmarkChange in Blood Lead Concentration for School Site Risk Assessment. Integrated Risk Assessment Branch Office ofEnvironmental Health Hazard Assessment California Environmental Protection Agency. April 2007. Available at http;i/www.oehha.org/public in**ro/public/ki~ls!pclflPbHGV041307.pdf.** 20 "Dangers ofLead Still Linger." FDA Consumer. U.S. Food and Drug Administration, January-February 1998. Available at http://ww.!y.cfsan.I((a.llov!dl11s!rdalead.htm1. 21 ConsumerProduct Safety Commission. Interim Enforcement Policy Lead Levels. February 14,2005. Available at**~~~~~~~~~~=~.~~~~~~~.** 22 Consumer Product Safety Commission. Interim EnforcementPolicy Lead Levels. February 14,2005. Available 

### ru**~~~~~~~,~~~~~~=~~~~~~~** 23 U.S. Geological Survey Professional Paper 1648. Geochemical Landscapes ofthe Conterminous United States New Map Presentations for 22 Elements. Figure 17. November200I. Available at !.l.l1P.:!lpllbs.lIsgs.gov/pp/p**1(,~48/p** 1648.pdf.


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