# Presentations Received in the Office ofthe Secretaryas of February 10, 2011 Public Hearing

- February 16, 2011 Children's Products Containing Lead; Technological Feasibility of 100 ppm for Lead Content

# AmericanAcademy ofPediatrics
DEDICATED TO THE HEALTH OF ALL**CHILDREN~**



### Wednesday, February 16, 2011 Testimonyof DanaBest, MD, MPH, F AAP

On behalfofthe AmericanAcademyofPediatrics

Before the ConsumerProductSafety Commission "Children's Products ContainingLead: Technological Feasibilityof 100ppmfor 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.orgDana 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 DanaBest, MD, MPH, FAAP, and I am pleased to represent the American Academy ofPediatrics (AAP), a non-profitprofessional organization of60,000primary 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 GeorgeWashington University School ofMedicine 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 primarybody within the AAP that handles lead and other environmental health issues. Under the ConsumerProduct Safety ImprovementAct of2008 (CPSIA), the ConsumerProduct Safety Commission (CPSC) is directed to reduce to 100 parts permillion (ppm) the allowable levels oflead in children's products in August 2011, "unless the Commission determines that a limitof 100 parts per million is not technologically feasible for a product orproduct category." The AAP appreciates the Commission's diligence in seeking public input about the public health and otherimpacts ofreducing the permissible lead levels to 100ppm. The Commissionhas undoubtedly received and reviewed a tremendous amount ofmaterial about the research behind lead exposure and its impact on child health. I will therefore give only a briefoverview ofthe state ofthe science. 

### LeadIs a Known Neurotoxin Lead has been recognized as a potentneurotoxin since the time ofthe Romanempire, although the mechanisms by which it inflicts brain damage have only been explored and understood in the pastcentury. Thebrain damage causedbylead 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 existfor treating lead exposure at low to moderate levels. Exposure to lead is amply documented to cause the loss ofintellectual capacity. On average, children whose bloodlead 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 of4 to 7 IQ points in children whose lead levels rose from 1 mcg/dL to 10 mcg/dL. These studies suggestthat "low" levels ofexposure ­ meaning BLLs less than 10 mcg/dL

- causeproportionately greaterharm than higherlevels. In addition to these impacts on IQ, lead exposure has documented effects onbehavior, with higher rates ofbehavioral problems reported in young children, teens and adults exposed to lead during childhood. Investigators have identified associationsbetween lead exposure and increased aggression, commission ofcrime and antisocial or delinquentbehaviors. Children with elevated lead are more likely to have problems with attention deficit, reading djsabilities, and to fail to graduate from high school. Othereffects include abnormal balance, poor eye-hand coordination, longerreaction times, and sleep disturbances.

Page 2 of6Dana 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 ofthis infonnation in mind, itis critically important to note that lead is bioaccumulative. Apercentage oflead will be excretedby 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 stores to 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. Further, a women'sblood lead in pregnancy puts her athigherrisk for complications from high blood pressure. A recent study in Environmental Health Perspectives found blood pressure to be about4-6 mmHg higherinwomen 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 ofleadpoisoning in American children at $43.4 billion. Costs are bornebyour health care, education, andjustice systems, among others. Lead is naturally present in ourenvironment atlow levels. Human activities have raised those levels through contamination, whetherby adding lead actively to products like paint or gasoline orproducing itas a byproduct ofactivities like burning coal. Lead is present at low levels in our air, soil, and water, butoften very difficult to remediate in those cases. Itis therefore critical to restrict lead exposure in environments directly under ourcontrol, such as consumerproducts. 

### MrsRole in the 

### CPSIA During the development ofthe CPSIA, the AAP was asked by Congress to recommend a limit for pennissible 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 detennined 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 77 to 4Oppm. The level of40ppm was also selected to fall above the naturally-occurringbackground levels of lead seen in various parts ofthe United States. The AAP worked closely with Congress throughout the development ofthe CPSIA to provide access to pediatric environmental health experts and researchers, who consulted on various aspects ofthe legislation. Thefinal 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 6Dana Best, MD, MPH, FAAP American Academy of Pediatrics Children's Products Containing Lead: Technological Feasibility of lOOppm 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 ReducingLeadLimitsfrom 300to IOOppm IntheJanuary 26 FederalRegisternotice, "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: "Whathealth effects are associatedwith a reduction ofthe lead content limit from 300 ppmto 100ppm? From 300ppm to some otherlevel above 100ppm?" Based on the AAP's previously-noted calculations, an objectcontaining 77ppm oflead is capable ofraising a child's blood lead level to a level that would result in the loss ofone IQ point. Please note that this is notmeant to be interpreted as a definitive statement for each exposed individual; rather, it is a public health statementrepresenting what will be true for the majority ofchildren. Individual children will have factors that eitherincrease ordecrease their vulnerability. Forthe majority ofchildren, ingestion ofan itemcontaining 300ppm oflead would result in the loss ofalmost 4 (3.9) IQ points. Ingestion ofan objectcontaining 100ppm lead wouldresult in the loss of justover one (1.3) IQ points. When averaged across even a modest population ofchildren, the public health harm causedby 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. For one million children, it would total over $8.3 billion. OtherImportantIssues Relatedto LeadExposure The Commission has received numerous comments regarding the feasibility ofreducing permissiblelead levels from 300to 100ppm. With those in mind, theAAP would urge the Commission to keep some additional points in mind. Children mustbeprotected from both acuteandchronic exposureto lead. Cases where exposure to a single lead-laden objectcan cause severe orfatal lead poisoning are, happily, rare. The CPSIA focused on preventing the often-invisiblebutpernicious cases ofsilent lead poisoning, where parents orcaregivers are unaware that lead exposure ever occurs. The Commission must remember that lead accumulates in the body and exposurecan come from multiple sources, so exposure mustbe limited as much as possible from each individual product 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 lOOppm for 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, orboth. Exposures ininfancy will notbe detected until at least age one, and those that take place after the age oftwo years may neverbe detected. In some communities where the risk oflead poisoning from older housing stock is deemed low, testing for blood lead levels may notbe performed at all. As a result, parents may neverbe 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 orprotecttheir children. It is the responsibility ofthe Commission to provide that protection for children and families. 

### Riskassessment ofindividualproducts orclasses of products is impracticalandsubjective. Somehaverecommended that the 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 ofhaving 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. Forall ofthese reasons, the AAP urges you to reject calls for risk assessmentrelated to individual products and the amount oflead that should be permitted in them. 

### Leadlimits shouldbe basedon 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 agencyto 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 compliancereliably. Challenges with consistency among tests performedbylaboratories shouldlead 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 of lOOppm as the appropriate standard protective ofchild health. 

### CPSCshouldcollaborate closely with companies working to comply ingood faith. TheAAP appreciates thatboth the Commission and individual companies will undoubtedly face challenges related to compliance. Inparticular, 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 thatreduce the regulatoryburden while also preserving childhealth and safety. In conclusion, I appreciate this opportunity to offer comments on behalfofthe American Academy ofPediatrics. TheAAP 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 Sof6Dana Best, MD, MPH, FAAP American Academy of Pediatrics Children's Products Containing lead: Technological Feasibility of 100ppmfor lead Content February 16, 2011

to work closely with those remaining companies who 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 assist you in any way in this important undertaking. Please do nothesitate to call upon us.

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### 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 ofthe American Academy of Pediatrics' Council on Environmental Health, I would like to request the opportunity to make an oral presentation atthe February 16, 2011 hearing entitled "Technological Feasibility of 100 ppm for Lead Content." Dr. Best's remarks on behalf ofthe American Academy of Pediatrics are attached. Please contact me ifyou 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**

1Comments ofConsumers Union ofUnited States, Inc. to the U.S. Consumer Product Safety Commission on 

### "Children'sProdncts ContainingLead: Technological Feasibility of100 ppm for Lead Content" Presented by Donald Mays On behalfofConsumers Union and ConsumerFederation ofAmerica February 16,2011
Thankyou for the opportunity to commenton the technological feasibility of 100 ppm for lead content in children's products. My name is Don Mays, SeniorDirector ofProduct Safety and Technical Policy for ConsumersUnion, the non-profit publisher ofConsumer Reports. I offer my comments today on behalfofConsumers Union and Consumer Federation ofAmerica.

The scientific evidence is clear: There is no known safe level oflead 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 oflead exposure also pose a serious economic burden on American society and are costing us tens ofbillions ofdollars. Itis clearthatwe must do whatever we can to eliminate our children's exposureto this harmful toxin.
Unfortunately, lead is ubiquitous in ourenvironment. 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 oflead do reside in certain raw materials, we strongly believe that manufacturers can and should make children's products with very low levels oflead. In addition, we are staunchly opposed to the intentional addition oflead 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 ofAugust 11,2011, children'sproducts may not contain more than 100 parts per million (ppm) total lead unless the Consumer Product Safety Commission (CPSC) determines thatthis standard is nottechnologically feasible. Our evidence proves that it is.

o In 2007, Consumer Reports tested a toy blood pressure cuffmade by Fisher-Price that contained a high concentration oflead. One ofseveral samples we tested measured as many as 10,000 ppm oflead. At the time it was sold, this toy was not in violation ofany Federal regulations (since the CPSIA was not yet law). However, since that time, Fisher-Price has redesigned their blood pressure cuff. Subsequenttests have shown that a new model had only 47ppm oflead.

o In 2006 we also found several children'svinyl lunch boxes that contained high levels oflead, ranging from about 4,600 to more than 11,000 ppm. Ourtests 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 screeningtests ofa few bags we recently purchased did not indicate the presence oflead.

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 ofthis same product,
we found that they are now labeled as "lead free." Indeed, our tests ofthe new samples showed onlytrace amounts oflead 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 ofthe CPSIA.

These examples demonstrate that it is technologically feasible to make children's products with CPSIA-compliant levels oflead.

... 2In addition, current regulations for paint set the limit for lead at 90 ppm. Before CPSlA, that limit was 600 ppm. The fact that paint companies are currently complying withthe
new standard shows that reducing lead in paint to under 90ppm 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 selectthe 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 currentlyunregulated.

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 oris 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 ofexposure to sunlight and heat. In fact, ofthe many samples ofFisher-Price toyblood 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 betterto rely on the precise test results afforded bythe current emission spectroscopytests widely used for lead testing. Therefore, it is imperative that the regulation continue to rely on total lead content, notjustlead that is accessible when the product is new.



### 3In regard to detection limits andtest precision, some argue that current test methods cannot accurately measure lead levels below or around 100 ppm. This argument is incorrect. Use ofconventional emission spectrometry test methods such as atomic absorption (AA) or inductively coupled plasma (ICP) can detect lead in the parts per billion range- magnitudes lowerthan the proposed 100 parts per million limit. Those procedures generally have a precision range ofabout 1to 5 percent. Therefore, with a sample that measures 100 ppm, for instance, one would expect to have no more than a standard deviation ofplus or minus 5 ppm.
Another significant advantage ofthe currenttest method is its ability to measure the levels ofseveral other elements

- like other heavy metals

- present in the product atthe
same time as measuring lead levels. In the future, should the CPSC write regulations for the use oftotal cadmium orother 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 oftesting. The listprice 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 oflead in children's products to 100 ppm, as required bythe CPSIA, is technologically feasible. Companies have already begun to comply with the statute's mandates, and our testing has shown that products previously containinghigh levels oflead have now been redesigned so that they contain less than 100 ppm oflead. The FJATA have also acknowledged the introduction ofa 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.

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### 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 CFATestimony
- Lead
- 2.16.2011.pdf

To Whom It May Concern: Please find attached the comments ofConsumers Union and ConsumerFederation ofAmerica, to be delivered atthe public hearing on February 16,2011. Don Mays, 

### Senior Director ofProduct Safety and Technical Policy for Consumers Union, will be delivering these comments in person at the hearing. Please do nothesitate to contact me should youhave any questions orconcerns. 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 ofConsumer Reports'" EXPERT. INDEPENDENT. NONPROFIT 

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