Presentations Received in the Office 


of the Secretary as of 


February 10, 2011 


Public Hearing - February 16, 2011 


Children's Products Containing Lead; 


Technological Feasibility of 100 ppm 


for Lead Content 

American Academy 

of Pediatrics 

DEDICATED TO THE HEALTH OF ALL CHILDREN~ 

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 


601 13th Street NW, Suite 400 North • Washington, DC 20005 


Tel: 800.336.5475 • E-mail: kids1st@aap.org 

Dana Best, MD, MPH, FAAP 

American Academy of Pediatrics 

Children's Products Containing lead: 

Technological Feasibility of 100ppm 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 of 2008 (CPSIA), the Consumer Product 

Safety Commission (CPS C) is directed to reduce to 100 parts per million (ppm) the allowable 

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 (mcgJdL) 

lose two to three IQ points. More recent studies have shown an even greater impact on IQ of 

BLLs under 10 mcgJdL. Key studies reported a loss of 4 to 7 IQ points in children whose lead 

levels rose from 1 mcg/dL to 10 mcg/dL. 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. Children with 

elevated lead are more likely to have problems with attention deficit, reading djsabilities, and to 

fail to graduate from high school. Other effects include abnormal balance, poor eye-hand 

coordination, longer reaction times, and sleep disturbances. 

Page 2 of6 
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 aU of this infonnation 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 of lead 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. Iflead has 

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

throughout pregnancy. 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. 

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. Other studies have estimated the 

annual cost of lead poisoning in American children at $43.4 billion. Costs are borne by our 

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. 

Mrs Role in the CPSIA 

During the development of the CPSIA, the AAP was asked by Congress to recommend a limit 

for pennissible levels of lead in children's products. The Academy engaged in a rigorous 

scientific process involving a review of the pertinent literature and ultimately recommended that 

lead be limited to 40ppm. AAP pediatric environmental health experts detennined 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 4Oppm. 

The level of 40ppm was also selected to fall above the naturally-occurring background levels of 

lead seen in various parts of the United States. 

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 mcgJdL 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 lOOp pm 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 from 300 to IOOppm 

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 lead 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. Individual children will have factors that either increase or decrease their 

vul nerabili ty. 

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

loss of almost 4 (3.9) IQ points. Ingestion of an 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-half of one percent of all children would mean exposure of 3.75 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 from 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 product 

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 lOOp pm for Lead Content 

February 16, 2011 

Harm from 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 of lead 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 of their 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 of the 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 of having 

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 

of the 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 of these 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 accessible 

lead and the fact that accessibility can change over time (e.g. as certain materials degrade) led 

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 lOOppm 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 of testing. 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 of the American 

Academy of Pediatrics. The AAP urges the Commission to continue placing the highest priority 

on protecting children from lead exposure and its devastating consequences. Large numbers of 

children's products currently on the market already comply with lead limits; we encourage you 

Page Sof6 
Dana Best, MD, MPH, FAAP 

American Academy of Pediatrics 

Children's Products Containing lead: 

Technological Feasibility of 100ppm for lead 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. 

Page 6of6 
Stevenson, Todd 

From: Kristen Mizzi [KMizzi@aap.org] 

Sent: Thursday, February 10, 20114:14 PM 

To: CPSC-OS 

Subject: 100 PPM-Technological Feasibility Public Hearing 

Attachments: 02-16-11 CPSC 100ppm lead statement.PDF 

Good afternoon, 

On behalf of Dana Best, MD MPH FAAP, Member of the American Academy of Pediatrics' Council on Environmental 

Health, I would like to request the opportunity to make an oral presentation at the February 16, 2011 hearing entitled 

"Technological Feasibility of 100 ppm for Lead Content." Dr. Best's remarks on behalf of the American Academy of 

Pediatrics are attached. Please contact me if you have any questions. 

Thank you/ 

Kristen Mizzi 

Kristen Mizzi 

Legislative Assistant 


American Academy of Pediatrics 


601 13th St. NW, Suite 400N 


Washington, D.C. 20005 


Ph: 202-347-8600 


Fax: 202-393~137 

1 
Comments ofConsumers Union of United States, Inc. 

to the U.S. Consumer Product Safety Commission on 

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

for Lead Content" 

Presented by Donald Mays 


On behalf of Consumers Union and Consumer Federation of America 


February 16,2011 


Thank you for the opportunity to comment on the technological feasibility of 100 ppm for 

lead content in children's products. My name is Don Mays, Senior Director of Product 

Safety and Technical Policy for Consumers Union, the non-profit publisher of Consumer 

Reports. I offer my comments today on behalf ofConsumers Union and Consumer 

Federation of America. 

The scientific evidence is clear: There is no known safe level of lead exposure. Lead is a 

potent neurotoxin that can cause permanent, irreversible brain damage. Children are 

especially susceptible to its toxic effects. A child's exposure to lead can result in lifelong 

harms, such as reduced IQ, learning disabilities, aggressive behavior, and serious and 

long-lasting effects on heath and well-being. Cumulative lifetime exposure has also been 

linked to neurotoxicity and cardiovascular effects later in life. The health effects of lead 

exposure also pose a serious economic burden on American society and are costing us 

tens of billions of dollars. It is clear that we must do whatever we can to eliminate our 

children's exposure to this harmful toxin. 

Unfortunately, lead is ubiquitous in our environment. Because lead has been used for 

years in paint, gasoline, and plumbing, it has now contaminated our soil, water, and air. 

Despite the fact that trace amounts of lead do reside in certain raw materials, we strongly 

believe that manufacturers can and should make children's products with very low levels 

of lead. In addition, we are staunchly opposed to the intentional addition of lead to 

children's products. Any such addition is completely unwarranted and should not be 

permitted. 
Section 101(a) ofthe Consumer Product Safety Improvement Act of2008 (CPSIA) 

requires that, as of August 11,2011, children's products may not contain more than 100 

parts per million (ppm) total lead unless the Consumer Product Safety Commission 

(CPSC) determines that this standard is not technologically feasible. Our evidence 

proves that it is. 

o 	 In 2007, Consumer Reports tested a toy blood pressure cuff made by Fisher-Price 

that contained a high concentration oflead. One of several samples we tested 

measured as many as 10,000 ppm of lead. At the time it was sold, this toy was 

not in violation of any Federal regulations (since the CPSIA was not yet law). 

However, since that time, Fisher-Price has redesigned their blood pressure cuff. 

Subsequent tests have shown that a new model had only 47 ppm of lead. 

o 	 In 2006 we also found several children's vinyl lunch boxes that contained high 

levels oflead, ranging from about 4,600 to more than 11,000 ppm. Our tests 

proved that the lead in these bags could transfer to unwrapped foods. Now, many 

vinyl lunch boxes are labeled as 100% lead-free. Indeed, XRF screening tests of a 

few bags we recently purchased did not indicate the presence of lead. 

o 	 Just last year, our tests also uncovered a children's vinyl raincoat made by 

Kidorable's that contained in excess of 1,000 ppm lead - a level that exceeds 

CPSIA regulations. But when we purchased new samples of this same product, 

we found that they are now labeled as "lead free." Indeed, our tests of the new 

samples showed only trace amounts of lead in the new products, in the order of 

about 10 ppm. The manufacturer told us that it had reformulated its vinyl 

products to comply with the new provisions of the CPSIA. 

These examples demonstrate that it is technologically feasible to make children's 

products with CPSIA-compliant levels oflead. 

... 

2 

In addition, current regulations for paint set the limit for lead at 90 ppm. Before CPS lA, 

that limit was 600 ppm. The fact that paint companies are currently complying with the 

new standard shows that reducing lead in paint to under 90 ppm was technologically 

feasible. 

Lowering the lead limit on children's products tol00 ppm may require manufacturers that 

do not have good quality control practices to tighten up their processes. Manufacturers 

may need to more carefully select the materials used in their products, and test those 

materials before the product is manufactured. New limits may, for example, prevent the 

use ofreground vinyl or electronic circuit boards in children's products. This would be a 

positive result, because reconstituted materials often contain other toxic substances such 

as cadmium, which is currently unregulated. 

It has been argued that lead poses a hazard only when it is shown to be accessible and 

soluble in an acid solution that simulates saliva or stomach acid. We disagree. Since 

lead is not always molecularly bound to the material matrix or substrate in which it is 

used, it can be liberated as the product ages or is exposed to mechanical manipulation, 

environmental ozone, and ultraviolet light. That is why the CPSC worked with the 

Window Covering Safety Council more than 10 years ago to eliminate lead in vinyl 

window blinds, which were found to liberate lead dust as a result of exposure to sunlight 

and heat. In fact, ofthe many samples of Fisher-Price toy blood pressure cuffs we tested, 

the highest levels were found in one that had been in use for two years. In addition, 

extraction or solubility tests for heavy metals can be imprecise, having widely variable 

results due to the time required for extraction, agitation level, temperature, ambient light 

conditions, and solute to sample ratio. From a compliance and enforcement standpoint, it 

is far better to rely on the precise test results afforded by the current emission 

spectroscopy tests widely used for lead testing. Therefore, it is imperative that the 

regulation continue to rely on total lead content, not just lead that is accessible when the 

product is new. 

3 

In regard to detection limits and test precision, some argue that current test methods 

cannot accurately measure lead levels below or around 100 ppm. This argument is 

incorrect. Use of conventional emission spectrometry test methods such as atomic 

absorption (AA) or inductively coupled plasma (ICP) can detect lead in the parts per 

billion range - magnitudes lower than the proposed 100 parts per million limit. Those 

procedures generally have a precision range of about 1 to 5 percent. Therefore, with a 

sample that measures 100 ppm, for instance, one would expect to have no more than a 

standard deviation of plus or minus 5 ppm. 

Another significant advantage ofthe current test method is its ability to measure the 

levels of several other elements - like other heavy metals - present in the product at the 

same time as measuring lead levels. In the future, should the CPSC write regulations for 

the use of total cadmium or other heavy metals used in children's products, the cost 

increment to conduct testing for those heavy metals would be negligible since the testing 

for those substances could be carried out simultaneously with the lead tests. 

In regard to costs, reducing the lead limit to 100 ppm should not have an impact on the 

cost of testing. The list price for lead testing by independent labs in the U.S. is typically 

$60 to $90 per sample, and only $20 to $40 in Asia. 

In conclusion, lead is an extremely potent neurotoxin that can cause irreversible brain 

damage to children. Reducing the level of lead in children's products to 100 ppm, as 

required by the CPSIA, is technologically feasible. Companies have already begun to 

comply with the statute's mandates, and our testing has shown that products previously 

containing high levels of lead have now been redesigned so that they contain less than 

100 ppm of lead. The FJATA have also acknowledged the introduction of a CPSIA· 

compliant crystal into the market. In addition, the current testing method for evaluating 

lead levels is sufficiently precise, because it can detect lead in the parts per billion range. 

Consumers Union and Consumer Federation ofAmerica strongly believe that the 100 

ppm lead limit is both reasonable and technologically feasible, and encourage the 

Commission to implement this requirement as soon as possible. 

4 
Stevenson, Todd 

From: Rusu, loana [IRusu@consumer.org1 

Sent: Thursday, February 10, 20115:48 PM 

To: CPSC-OS 

Cc: Gadhia, Ami; Rachel Weintraub; Mays, Don; Bloom, Ellen 

Subject: 100 PPM-Technological Feasibility Public Hearing - CU and CFA Comments 

Attachments: CU CFA Testimony - Lead - 2.16.2011.pdf 

To Whom It May Concern: 

Please find attached the comments ofConsumers Union and Consumer Federation of America, to be delivered at the public hearing on 

February 16,2011. Don Mays, Senior Director of Product Safety and Technical Policy for Consumers Union, will be 

delivering these comments in person at the hearing. 

Please do not hesitate to contact me should you have any questions or concerns. 

Sincerely, 

loana Rusu 

Consumers Union - Washington Office 

Regulatory Counsel 

1101 17th Street, NW Suite 500 

Washington, DC 20036 

Tel: (202) 462-6262 

Fax: (202) 265-9548 

Consumers Union'" Publisher of Consumer Reports'" 

EXPERT. INDEPENDENT. NONPROFIT 

J; please co~sider the e'1vironment before pri'1ting thiS email 

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