American Academy of Pediatrics 

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, Suite 400 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 

District V 

Marilyn J. Bull. MD. FAAP 

Indianapolis, IN 

District VI 

Michael V, Severson, MD, FAAP 

Brainerd, MN 

District VII 

Kenneth E, Matthews, MD, FAAP 

College Station, TX 

District VIII 

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 Commissioner Nord: 

Thank you for this opportunity to respond to your questions following my 

testimony on behalf ofthe American Academy of Pediatrics (AAP) on February 

16,2011 at the Consumer Product Safety Commission (CPSC) hearing, 

"Children's Products Containing Lead: Technological Feasibility of 100ppm for 

Lead Content." 

1. 	 You quoted studies that estimated annual cost oflead poisoning in American 

children at $43.4 billion. And that any time average blood lead levels increase 

by 1 microgram per deciliter across children born in any given year, $7.5 

billion is lost in potential earnings for those children. Where did you get your 

data? Please submit all ofthe studies you reference so staffcan review them. 

Attached is a version of my testimony with all sources cited. 

2. 	 You state that for a majority ofchildren, ingestion ofan item containing 300 

ppm oflead would result in the loss ofalmost 4 IQ points and ingestion ofan 

object containing 100 ppm would result in the loss ofjust over 1 IQ points. 

Please submit studies used to arrive at these conclusions. 

Again, the attached copy of my testimony contains references to all ofthe studies. 

J have also attached a copy of a 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's products to 40 parts per million 

(ppm). 

3. 	 Did the studies you reference relating to the loss ofIQ points due to ingestion 

oflead base their findings on exposure just to children's products or were they 

based on exposure to leadfound in general use products, housing and the 

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 of exposure. 
4. 	 Were the calculations on the effects oflead ingestion based on the assumption the 

item gets swallowed by the child? Do all materials act the same way when ingested? 

Calculations are based on the assumption that an item or some portion of it (including a 

part, piece, chip, or residue) is ingested. As stated above, lead does not behave 

differently in the body based upon the source of exposure. The composition ofthe item 

ingested may, however, contribute to the degree of exposure. The amount of lead that 

enters the bloodstream may variously depend upon the size or amount of the material 

ingested, its form, and other factors. For example, some items may pass through the 

digestive tract 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 ofa bike or a brass drawer pull present the same risk as an infant rattle or 

toddler pull toy? 

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 of reports 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 

similar data, with frequency of oral behaviors and minutes/day of mouthing. The amount 

of lead that would be transferred to a child may depend on mouthing behavior 

(times/hour and minutes/day) and the transfer rate of lead from the object to 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 of 4 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 Commission should use the flexibility granted by Congress under 

CPSIA. Can you please provide some specific examples ofhow we should apply this 

flexibility. For example should the Commission use its discretion to look at 

technological ftasibility for that category ofproducts 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 product that 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 of the term; 

(3) industrial strategies or devices have been developed that are capable or will be 

capable of achieving such a limit by the effective date of the limit and that companies, 

acting in good faith, are generally capable of adopting; or 
(4) alternative practices, best practices, or other operational changes wou ld allow the 

manufacturer to comply with the limit. 

The conference report further notes: 

The Coriference Report ultimately requires that the Commission lower the permissible 

lead level in children's products to the lowest amount that is technologically feasible. 

This section provides a definition oftechnologically feasible, and includes a provision 

identifying alternative practices. best practices, or other operational changes that would 

allow a manufacturer to comply with the lead limit. The intent ofthis alternative and best 

practices provision is to require manufacturers to use better methods ofproducing a 

product that can be achieved without the need for major technological advances. such as 

taking steps to better clean equipment or the factory, or to make changes in operation, 

maintenance, or other practices that can reduce or eliminate lead in the product. 3 

The statute's carefully-crafted definition of technological feasibility does not make 

allowance for the introduction of risk assessment as a factor in making these 

determinations. In fact, it may be inferred from its exclusion that the intent of Congress 

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, thank you for this opportunity to respond to your questions. If the American 

Academy of Pediatrics or I may be of further assistance, please contact Cindy Pellegrini 

in the AAP's Washington, DC office at 202/347-8600. 

Sincerely, 

/ ' J 

Dana Best, MD MPH F AAP 

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 of blood lead among bridge painters. J Occup Environ Hyg, 2010 


F eb;7(2):80-7. 


3 Conference report 110-787, to accompany H.R. 4040, the Consumer Product Safety Improvement Act of 


2008, 

Anlerican AcadetTIv 

of Pediatrics .I 

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

Wednesday, February 16, 2011 

Testimony of 

Dana Best, MD, MPH, F AAP 

On behalf of the 

American Academy of Pediatrics 

Before the Consumer Product Safety Commission 

"Children's Products Containing Lead: Technological Feasibility of 100ppm for 

Lead Content" 

American Academy of Pediatrics • Department of Federal Affairs 


60113th Street NW, Suite 400 North • Washington, DC 20005 


Tel: 800.336.5475 • E-mail: kidslst@aap.org 

Dana 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 Commissioners Adler, Moore, Nord and Northup, thank you for this 

opportunity to speak to you today. My name is Dana Best, MD, MPH, FAAP, and I am pleased 

to represent the American Academy of Pediatrics (AAP), a non-profit professional organization 

of 60,000 primary care pediatricians, pediatric medical sub-specialists, and pediatric surgical 

specialists dedicated to the health, safety, and well-being of infants, children, adolescents, and 

young adults. I am an Associate Professor of Pediatrics at George Washington University School 

of Medicine and an attending physician at Children's National 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. 

Under the Consumer Product Safety Improvement Act of2008 (CPSIA), the Consumer Product 

Safety Commission (CPSC) is directed to reduce to 100 parts per million (ppm) the allowablc 

levels of lead in children's products in August 2011, "unless the Commission determines that a 

limit of 100 parts per million is not technologically feasible for a product or product category." 

The AAP appreciates the Commission's diligence in seeking public input about the public health 

and other impacts of reducing the permissible lead levels to 100ppm. 

The Commission has undoubtedly received and reviewed a tremendous amount of material about 

the research behind lead exposure and its impact on child health. I will therefore give only a 

brief overview of the state of the science. 

Lead Is a Known Neurotoxin 

Lead has been recognized as a potent neurotoxin since the time of the 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 of intellectual 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 of 4 to 7 IQ points in children whose lead 

2 levels rose from 1 mcg/dL to 10 mcgJdL. 1

• These studies suggest that "low" levels of exposure 

- meaning BLLs less than 10 mcg/dL cause proportionately greater harm than higher levels. 

In addition to these impacts on IQ, lead exposure has documented effects on behavior, with 

higher rates of behavioral problems reported in young children, teens and adults exposed to lead 

during childhood. Investigators have identified associations between lead exposure and 

increased aggression, commission of crime 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 of 6 
Dana Best, MD, MPH, FAAP 

American Academy of Pediatrics 

Children's Products Containing Lead: 

Technological Feasibility of 100ppm for Lead Content 

February 16, 2011 

With all ofthis information in mind, it is critically important to note that lead is bioaccumulative. 

A percentage of lead will be excreted by the body, and the rate of clearance is dependent on a 

number of factors, 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 stores to create her fetus's bone structure. If lead has 

been stored in the bone, the developing fetus will be exposed to doses of lead 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 pressure to 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 

The costs associated with lead exposure are tremendous. Health economists estimate that 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, and justice systems, among others. 

Lead is naturally present in our environment at low levels. Human activities have raised those 

levels through contamination, whether by adding lead actively to products like paint or gasoline 

or producing it as a byproduct of activities 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's Role in the CPSIA 

During the development of the CPSIA, the AAP was 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 ofthe pertinent 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 of raising a child's 

blood lead level to a level that would result in the loss of one IQ point. Recognizing that most 

children are exposed to other sources of lead and that it is bioaccumulative, the AAP 

recommended a twofold margin of safety and reduced the recommendation from 77 to 40ppm. 

The level of40ppm was also selected to fall above the naturally-occurring background levels of 

lead seen in various parts of the United States. 14 

The AAP worked closely with Congress throughout the development of the CPSIA to provide 

access to pediatric environmental health experts and researchers, who consulted on various 

aspects of the 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 of 6 
Dana 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 ofReducing Lead Limits (rom 300 to 100ppm 

In the January 26 Federal Register notice, "Children's Products Containing Lead; Technological 

Feasibility of 100 ppm for Lead Content," the CPSC requested public comment on several 

specific questions. The AAP would like to provide information on #6: "What health effects are 

associated with a reduction of the lead content limit from 300 ppm to 100 ppm? From 300 ppm 

to some other level above 100 ppm?" 

Based on the AAP'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 of one IQ 

point. Please note that this 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 of children. Ind ividual children will have factors that either increase or decrease their 

vulnerability. 

For the majority of children, ingestion of an item containing 300ppm of lead would result in the 

loss ofalmost 4 (3.9) lQ points. Ingestion ofan object containing 100ppm lead would result in 

the loss ofjust over one (1.3) IQ points. 

When averaged across even a modest population of children, the public health harm caused by 

lead is significant. Considering that there are about 75 million children in our nation, impacting 

one-halfof one percent of all children would mean exposure of3.75 million children. Respected 

economic studies estimate the loss of lifetime 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. For one million children, it would total over $8.3 billion. 

Other Important Issues Related to Lead Exposure 

The Commission has received numerous comments regarding the feasibility of reducing 

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 must be protected/rom both acute and chronic 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 of silent lead 

poisoning, where parents or caregivers are unaware that lead exposure ever occurs. 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 of 6 
Dana Best, MD, MPH, FAAP 

American Academy of Pediatrics 

Children's Products Containing Lead: 

Technological Feasibility of 100ppm for Lead Content 

February 16, 2011 

Harmfrom lead is usually invisible. Most children are tested either once or twice for lead 

exposure, either around the ages of one or two years, or both. Exposures in infancy will not be 

detected until at least age one, and those that take place after the age of two 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 if a given object contains lead, so they are powerless to control 

exposure or protect their children. It is the responsibility ofthe Commission to provide that 

protection for children and families. 

Risk assessment ofindividual products or classes ofproducts is impractical and subjective. 

Some have recommended that the CPSC engage in some form of risk assessment to determine 

the levels of lead 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 introduce tremendous levels of 

SUbjectivity into this process and remove any certainty for parents and caregivers about the 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 of lead that should be permitted in them. 

Lead limits should be based on total, rather than accessible, lead levels. Congress thoroughly 

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 

Congress to 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 of protocols used. Laboratory issues do not, 

however, negate the validity of IOOppm as the appropriate standard protective of child health. 

CPSC should collaborate closely with companies working to 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 offer comments on behalf ofthe 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 of 6 
Dana 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 companies who still face compliance challenges to identify 

solutions. In any small number of cases 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 assist you 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, lusko TA, Lanphear BP. Intellectual impairment in 

children with blood lead concentrations below 10 microg per deciliter. N Engl J 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 and juvenile delinquency. 

Neurotoxicol Teratol. Nov-Dec 200 I ;23( 6):511-518. 

4 Ris MD, Dietrich KN, Succop PA, Berger OG, Bornschein RL. Early exposure to lead and neuropsychological 

outcome in adolescence. J In! Neuropsychol Soc. Feb 2004:261-270. 

5 Burns 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 Port Pirie Cohort Study. Am.! 

Epidemiol. Apr 151999;149(8):740-749. 

6 Nevin R. Understanding international crime trends: the legacy of preschool lead exposure. Environ Res. 

2007; 104(3):315-336. 

7 Centers for Disease Control and Prevention. Managing Elevated Blood Lead Levels Among Young Children: 

Recommendations/rom the Advisory Committee on Childhood Lead Poisoning Prevention. Atlanta, GA: Centers for 

Disease Control and Prevention; 2002. 

8 Bhattacharya A, Shukla R, Dietrich KN, Bornschein RL. Effect of early 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-Aden A, 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. Environ Health 

Perspect. 2011; doi: 10.1289/ehp.l 002666 

12 Salkever D. Updated Estimates of Earnings Benefits from Reduced Exposure of Children to Environmental Lead. 

Environmental Res. 1995: 70:1-6. 

13 Landrigan PJ, Schechter CB, Lipton 1M, Fahs MC, Schwartz J. Environmental pollutants and disease in 

American children: estimates of morbidity, mortality, and costs for lead poisoning, asthma, cancer, and 

developmental disabilities. Environ Health Perspect 2002; 110:721-8. 

14 U.S. Geological Survey Professional Paper 1648. Geochemical Landscapes of the Conterminous United States 

New Map Presentations for 22 Elements. Figure 17. November 2001. A vall able at 

http;!!pubs.lIs:cs.gov/pp!p16.t8/p I M8.pdf. 

Page 6 of 6 
American AcadenlY of Pediatrics 

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 of Federal 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 

Henry A Schaeffer, MD, FAAP 

Brooklyn, NY 

District III 

Sandra Gibson Hassink, MD. FAAP 

Wilmington, DE 

District IV 

Francis E. Rushton, Jr, MD, FAAP 

Beaufort. SC 

District V 

Marilyn J. Bull, MD, FAAP 

Indianapolis, IN 

District VI 

Michael V. Severson, MD, FAAP 

Brainerd. M N 

District VII 

Kenneth E. Matthews. MD, FAAP 

College Station, TX 

District VIII 

Mary P Brown. MD. FAAP 

Bend, OR 

District IX 

Myles B. Abbott. MD. FAAP 

Berkeley, CA 

District X 

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 Academy ofPediatrics, 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 of infants, children, adolescents, 

and young adults, appreciates this opportunity to respond to your inquiry for more details 

on the development of our recommendations for limiting lead content in children's 

products. 

Lead and Children's Health 

There is no "safe" level of lead exposure. The vulnerability of children 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 of BLLs under 10 mcg/dL. Key stud ies 

reported a loss of 4 to 7 IQ points in children whose lead levels rose from 1 mcg/dL 10 10 

mcg/dL. 1,2 These studies suggest that "low" levels of exposure - meaning BLLs less than 

10 mcg/dL cause proportionately greater harm than higher levels. The effects of lead 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 of7 year old children who had experienced a BLL of20­

44 mcg/dL around age 2 years, the concurrent BLL (i.e., BLL taken 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 or age 5 years.3 

Another important lasting effect of lead 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 of failing to graduate from high schoo\.4 Investigator, have identilicd 

associations between lead exposure and increased aggression, commission of crime 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 1,12 
Lead is easily absorbed by ingestion or inhalation. The most common route of exposure 

of children 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 or objects placed in the mouth have lead, these usual childhood activities deliver 

doses of lead. 

Once lead enters the body it remains there for years. Lead is similar to calcium from the 

elemental perspective. This means that our bodies "see" lead as calcium, absorb it into 

blood and then store it in bone. These stores of lead can be released 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 or years have an additive 

effect on the body's burden of lead 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 of lead. 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 of lead from gasoline and mandated restriction of lead content in paint. 

At the same time, however, elevated BLL is still not uncommon. Eliminating elevated 

blood lead levels was established as a key goal under the 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 past three years alone, the 

AAP has pushed the Environmental Protection Agency to reduce airborne lead emissions 

under the 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 of Housing and Urban Development to 

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 of exposure are not 

created. 

Lead in Children's Products 

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 of lead in surface paint. The restriction of lead 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 other than 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 

component of materials used or as a deliberate or incidental additive. Lead is used 

2 
directly 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 that comes into contact with 

materials or components during the manufacturing process. Regardless of its source, 

however, lead's toxic 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. 

Development ofthe AAP Lead Recommendation 

In September 2007, the AAP was asked by the House Committee on Energy and 

Commerce to testify about the hazards of lead and to make specific recommendations for 

lead content that would be used in the development of pro duct 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 effort that 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 went to great lengths to 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 of materials 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 of exposure, a "trace" amount, 

could be expected. 

The primary goal ofthe COEH in developing these recommendations was to establish a 

guideline based directly on child health issues, rather than the selection of an arbitrary 

number. After much discussion, the committee agreed that the appropriate benchmark for 

its recommendation should be the loss of 1 IQ 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 1 IQ point loss waul!] be 

prevented by limiting a child's BLL increase to no more than 1 mcg/dL,19 Supporting a 

rationale on 1 mcg/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 1 mcg/dL,20 

There is no logical reason to accept a higher rise in blood lead level from product 

exposure than from food exposure. 

3 
The COEH's next task was to determine the amount of lead that would result in a child's 

BLL increasing by 1 mcg/dL from exposure to a child's product. This evaluation focused 

on information posted by CPSC evaluations.21 The committee determined as follows: 

• 	 Based on the 1999-2000 National Health and Nutrition Examination Survey 

(NHANES), the average blood lead level of a child aged 1-5 years in the US in 

1999-2000 was 2.2 mcg/dL. 

• 	 In developing its recommendation for lead in toy jewelry, 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 of exposure occurs at a level of 0.06% 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 order to 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 that would 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 1 mcg/dL. 

In its next step, the COEH took into account the fact that most children are exposed to 

lead from a variety of sources, 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 important to provide a margin of 

safety to ensure that exposure to a single toy or children's product cannot cause BLL to 

increase 1 mcg/dL. 

In determining how to set this margin of safety, the COEH examined 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 about the natural geological occurrence 

of lead 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 out at 30 

ppm.23 The AAP confirmed this data with 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 note that this is considerably lower than the margin of safety mandated 

under other 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 estimated to cause the 

negative effect) for vulnerable populations, including children. 

Development ofthe CPSIA Standard and Exceptions Clause 

Over the year that 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 

4 
AAP collaborated on the development of legislative 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 of inaccessibility was the subject of much debate. For example, it 

was questioned whether lead would be considered inaccessible if it were covered by paint 

or electroplating, 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 of acid (including stomach fluids). 

In the final legislation, the CPSC is specifically directed to examine the application of the 

lead standard to electronic products, including batteries, and to develop guidelines for 

minimizing children's exposure to lead that cannot be eliminated from these products. 

The AAP supported these proposals, which will allow for the transparent, science-based 

evaluation of proposals 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 of the 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. Following that, AAP members and staff spent 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 com ing years. 

I hope this letter satisfies your request for information and gives you confidence that the 

AAP's recommendations represent an empirically-based solution grounded in science. If 

the Academy may be of further assistance, please contact Cindy Pellegrini in our 

Washington, D.C. Office at 202/347-8600. 

Sincerely, 

)~ I ..\
 \. 1\"'"'r: [ i . C:t \' J: !r ~.vt-(.• j (" 

David T. Tayloe, Jr., MD FAAP 

President 

DTT:cp 

5 
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at ~~~~~~~~~~=~.~~~~~~~. 

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ru ~~~~~~~,~~~~~~=~~~~~~~ 

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