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UNITED STATES CONSUMER PRODUCT

SAFETY COMMISSION

PUBLIC HEARING:

CHILDREN'S PRODUCTS CONTAINING LEAD,

TECHNOLOGICAL FEASIBILITY OF 100 PPM

FOR LEAD CONTENT

Wednesday, February 16, 2011

10:05 a.m.

United States Consumer Product Safety Commission

4330 East-West Highway

Bethesda, Maryland 20814

Hearing Room 420

Diversified Reporting Services, Inc.

(202) 467-9200

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PARTICIPANTS:

CONSUMER PRODUCT SAFETY COMMISSION

Inez M. Tenenbaum, Chairman

Thomas H. Moore, Commissioner

Robert S. Adler, Commissioner

Nancy A. Nord, Commissioner

Anne M. Northup, Commission

Melissa Hampshire, Assistant General Counsel

Kenneth R. Hinson, Executive Director

STAFF

Dominique Williams

Kris Hatlelid

Hyun Kim

Joel Recht

Randy Butturini

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C O N T E N T S

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PANEL 1

Dana Best, American Academy of Pediatrics 7

Don Mays, Consumers Union 20

PANEL 2

Stan Piorek, Thermo Fisher Scientific 58

Sanjeev Gandhi, SGS North America, Inc. 65

Milton Bush, International Federation of Inspection
Agencies (IFIA) & American Council of Independent

Laboratories (ACIL) 76

Quin Dodd, Mintz Levin PC, 87

and Satbir Nayar, XOS, Inc. 92

PANEL 3

Rick Woldenberg, Learning Resources, Inc. 135

Rick Locker, Toy Industry Association (TIA) & Juvenile

Products Manufacturers Association (JPMA) 149

Kirsten Chapman, Kleynimals.com 159

Erika Jones, John Nedeau and John Bogler,

Bicycle Products Supplier Association (BPSA)

& ACT Lab 177

John Bogler 168

John Nedeau 176

Erika Jones 177

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1 P R O C E E D I N G S

2 CHAIRMAN TENENBAUM: Good morning, everyone,

3 and welcome to the Consumer Product Safety Commission's

4 Public Hearing on the Technological Feasibility of

5 Meeting the 100 Parts per Million Lead Content Limit

6 for Children's Products and Associated Public Health

7 Considerations.

8 We would like to thank the Commission Staff,

9 who have been working hard on this issue, as well as

10 the witnesses, who are here to present their views to

11 us today, so that our decisions can be better informed.

12 Lead is a contaminant, and a powerful

13 neurotoxin, that accumulates in the body over time.

14 Children are particularly vulnerable to its effects.

15 Even small amounts can lead to IQ loss and

16 behavior problems in children. And these effects are

17 irreversible.

18 Congress through Section 101A of the Consumer

19 Product Safety Improvement Act of 2008, has mandated

20 that on August the 14th, 2011, all products intended

21 primarily for children 12 and under must meet the 100

22 parts per million lead content limit, unless the

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1 Commission determines that such a limit is not

2 technologically feasible for a product or a product

3 category.

4 I'm aware of the controversy about the

5 approach taken by Congress to prohibit lead content
6 limits above 100 parts per million in children's

7 products.

8 However, this is not the focus of today's

9 hearing. And I ask, given the limited time that we

10 have here today, that the witnesses, Commissioners, and

11 the Staff limit their discussion and questions directly

12 to the issues of technological feasibility and

13 associated public health considerations.

14 I'd also like to thank all the Commission

15 Staff participating today, particularly Dominique

16 Williams, who is in our Health Science Division, who is

17 the Project Manager for this issue;

18 And Kris Hatlelid, one of our agency

19 toxicologists, has been working closely with Dominique

20 on this issue.

21 I'd also like to give a brief overview of the

22 process today.

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1 We have three panels of witnesses. Two panels

2 will present, and then we'll break for about an hour,

3 around 12:30 or maybe close to 1:00.

4 After lunch, we will reconvene for the final

5 panel. Each witness may have up to ten minutes. After

6 all the witnesses on the panel present testimony,

7 Commissioners and the Commission Staff will have around

8 ten minutes -- not each, but collectively -- to ask

9 questions.

10 Todd Stevenson, the Commission Secretary, seen

11 in the front of the room -- you know Todd -- and he

12 will indicate to the witnesses when they have five

13 minutes, two minutes, and one minute.

14 I know that ten minutes for all the

15 Commissioners and the Staff to ask questions is a very,

16 very tight time frame. So I'm going to be flexible.

17 But I will ask that Commissioners not be

18 redundant or ask questions that are not directly on

19 point.

20 And also we are going to keep the record open,

21 because Commissioners may have questions as well as

22 Staff, that they want to write to the witnesses, to get

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1 written responses.

2 So we're going to try to be flexible, so that

3 we can get all of this in, and learn about this

4 important issue today.

5 Now on our first panel today is Don Mays from
6 the Consumers Union, and Dana Best, who is a physician.

7 And she represents the American Academy of Pediatrics.

8 So welcome.

9 And Dana, would you like to go first?

10 MS. BEST: Certainly.

11 Good morning, Chairman Tenenbaum and

12 Commissioners Adler, Moore, Nord, and Northup.

13 I thank you for this opportunity to speak to

14 you today. As you know, my name is Dana Best. I'm a

15 physician and a pediatrician, and a member of the

16 Academy of Pediatrics.

17 And I'm pleased to represent the American

18 Academy of Pediatrics, AAP, a non-profit professional

19 organization of 60,000 primary care pediatricians,

20 pediatric medical sub-specialists, and pediatric

21 surgical specialists, dedicated to the health, safety,

22 and well-being of infants, children, adolescents, and

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1 young adults.

2 I'm an associate professor of pediatrics at

3 George Washington University School of Medicine, and an

4 attending physician at Children’s National Medical

5 Center, here in Washington, D.C.

6 I served for six years on the AAP's Committee

7 on Environmental Health, which is the primary body

8 within the AAP that handles lead and other

9 environmental health issues.

10 Under the Consumer Product Safety Improvement

11 Act of 2008, the CPSIA, the Consumer Product Safety

12 Commission is directed to reduce to 100 parts per

13 million the allowable levels of lead in children's

14 products by August 2011, unless the Commission

15 determines that a limit of 100 parts per million is not

16 technologically feasible for a product line or product

17 category.

18 The AAP appreciates the Commission's diligence

19 in seeking public input about the public health and

20 impact and other impacts of reducing lead levels to 100

21 parts per million.

22 The Commission has undoubtedly received, and I

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1 have read, a tremendous amount of material about the

2 research behind lead exposure and its impact on

3 children's health.

4 I will therefore give only a brief overview.

5 First, lead is a known neurotoxin, as you
6 previously said. It's been recognized as a neurotoxin

7 since the time of the Roman Empire, although the

8 mechanisms by which it inflicts brain damage have only

9 been explored and understood in the past few years.

10 The brain damage caused by lead exposure is

11 permanent and irreversible. Few options exist for

12 treating lead exposure at high levels, and these

13 treatments are not only dangerous, but have their own

14 harms themselves.

15 No options exist for treating low levels of

16 lead exposure.

17 Exposure to lead is documented to cause loss

18 of intellectual capacity. And on average, children

19 whose blood lead levels rise from 10 to 20 mcg/dl lose

20 two to three IQ points.

21 More recent studies have shown an even greater

22 impact on IQ of blood lead levels under ten mcg/dl.

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1 Key studies reported a loss of four to seven

2 IQ points in children whose lead levels rose from one

3 mcg/dl to ten.

4 These studies suggest that low levels of

5 exposure, meaning blood lead levels less than ten

6 mcg/dl cause proportionately greater harm than the

7 higher lead levels.

8 In addition to these impacts on IQ, lead

9 exposure has documented effects on behavior, with

10 higher rates of behavioral problems reported in young

11 children, teens, and adults exposed to lead during

12 their childhood.

13 Investigators have identified associations

14 between lead exposure and an increased aggression,

15 commission of crime and antisocial or delinquent

16 behaviors.

17 Children with elevated lead are more likely to

18 have problems with attention deficit, reading

19 disabilities, and to fail to graduate from high school.

20 Other effects include abnormal balance, poor

21 eye-hand coordination, longer reaction times, and sleep

22 disturbances.

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1 With all of this information in mind, it's

2 critically important to note that lead is

3 bio-accumulative. That means that it will accumulate

4 in your body over time, throughout your lifetime.

5 While a percentage of lead will be excreted
6 from the body, the rate of clearance is dependent on

7 many factors, including nutritional status.

8 A percentage of lead is also stored in the

9 bone, or primarily in bone. There are other places

10 it's stored. These body stores can persist over

11 decades.

12 And one of the ways this is represented is

13 when a woman becomes pregnant, when her body draws upon

14 the calcium stores in her bones, and the lead is drawn

15 out at the same time, which then poisons the fetus from

16 day zero.

17 If lead has been stored in the bone, the lead

18 then gets released throughout the pregnancy.

19 Furthermore, a woman with lead in her bone

20 that is released during the pregnancy has a higher risk

21 of complications during her pregnancy from high blood

22 pressure, which is a cause of a lot of a lot of

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1 premature deliveries.

2 A recent study in Environmental Health

3 Perspectives found the blood pressure to be about 4-6

4 mmHg higher in women giving birth to infants with a

5 cord blood level of 1 to 6 mcg/dl, which is again a

6 very low level of lead, versus cord bloods of less than

7 measurable levels.

8 The costs associated with lead exposure are

9 tremendous. Health economists suggest that every time

10 the average blood lead level increases by a small

11 amount, which we define as 1 mcg/dl, across children

12 born in any given year, 7.5 billion -- with a

13 B -- dollars are lost in potential earnings for those

14 children over their lifetimes.

15 Other studies have estimated the annual cost

16 of lead poisoning in American children at $43.4

17 billion. Costs are borne by our health care system,

18 education, and justice systems, among others.

19 We know that and recognize that lead is

20 present in the environment at low levels. Human

21 activities have raised these levels by contamination,

22 whether by adding lead to products like paint, or to

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1 gasoline, or producing it as a byproduct of activities

2 like burning coal.

3 Lead is present at low levels in our air,

4 soil, and water, but it's often very difficult to

5 remediate in many of those stores of lead.
6 It's therefore critical to restrict lead

7 exposure in the environment directly under a control,

8 such as consumer products.

9 During the development of the CPSIA, the AAP

10 was asked by Congress to recommend a limit for

11 permissible levels of lead in children's products.

12 The Academy engaged in a rigorous scientific

13 process involving a review of the pertinent literature

14 and ultimately recommended that lead be limited to 40

15 parts per million.

16 AAP pediatric environmental health experts

17 determined that based on the most up-to-date science,

18 an object with 77 parts per million of lead would be

19 capable of raising a child's blood lead level, if

20 ingested, to a level that would result in the loss of

21 one IQ point.

22 Recognizing that most children are exposed to

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1 other sources of lead and that is bio-accumulative, the

2 AAP recommended a twofold margin of safety and reduced

3 the recommendation from 77 to 40.

4 The level of 40 parts per million was also

5 selected because it fell above the naturally occurring

6 background levels of lead in uncontaminated areas in

7 the United States.

8 The AAP worked closely with Congress

9 throughout the development of the CPSIA to provide

10 access to pediatric environmental health experts and

11 researchers, who consulted on several aspects of the

12 legislation.

13 The final bill represented a significant step

14 towards reducing children's exposure to lead,

15 particularly by setting limits where none had

16 previously existed on materials other than surface

17 coatings on children's products.

18 In the January 26 Federal Register Notice,

19 children’s products containing lead technological

20 feasibility of 100 parts per million for lead content,

21 the CPSC requested public comment on several specific

22 questions.

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1 The AAP would like to provide information on

2 Question No. 6: What health effects are associated

3 with a reduction of the lead content limit from 300

4 parts per million to 100 parts per million, and then

5 from 300 parts per million to some other level above
6 100 parts per million?

7 Based on the AAP's previously noted

8 calculations, an object containing 77 parts per million

9 of lead is capable of raising a child's blood lead

10 level to a level that would result in the loss of one

11 IQ point.

12 Please note that this is not meant to be a

13 definitive statement about every child has this effect.

14 Rather, it's a public health statement about the

15 population of children.

16 Individual children have factors that can

17 increase or decrease their vulnerability.

18 For the majority of children, ingestion of an

19 item containing 300 parts per million of lead would

20 result in the loss of almost four IQ points.

21 Ingestion of an object containing 100 parts

22 per million would result in the loss of over one IQ

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1 point.

2 When averaged across even a modest population

3 of children, the public health harm caused by lead is

4 significant. Considering that there are about 75

5 million children in our nation, impacting one-half of

6 one percent of all children would mean an exposure of

7 3.75 million children.

8 Several economic studies estimate the loss of

9 lifetime income at 1995 dollars of $8,346 for each loss

10 of one IQ point. For 10,000 children, that equals 83.4

11 million; for 100,000 children it would be $834 million.

12 For a million children, it would total over

13 $8.3 billion.

14 The Commission has received numerous comments

15 regarding the feasibility of reducing permissible lead

16 levels from 300 to 100 parts per million. With those

17 in mind, the APP would urge the Commission to keep some

18 additional points in mind.

19 Children must be protected from both acute and

20 chronic exposures to lead.

21 Cases where exposure to a single lead-laden

22 object can cause severe or fatal lead poisoning are

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1 happily rare, but not nonexistent.

2 The CPSIA focused on preventing the often

3 invisible but pernicious cases of silent lead

4 poisoning, the lead poisoning cases that we don't see,

5 in which parents or caregivers are even unaware that
6 lead exposure occurred.

7 The Commission must remember that lead

8 accumulates in the body and exposure can come from

9 multiple sources. So exposure must be limited as much

10 as possible from each individual source to avoid

11 accumulation to dangerous levels.

12 Second, harm from lead is usually invisible.

13 Most children are tested either once or twice for lead

14 exposure in their life, either around the ages of one

15 or two years, or both.

16 Exposures in infancy are not detected until at

17 least age one, and those that take place after age two

18 are usually never discovered.

19 In some communities, where the risk of lead

20 poisoning from older housing stock -- so, for instance,

21 a newer community unlike Washington, D.C. -- where the

22 risk of lead level from the paint is considered low,

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1 many children don't get tested at all.

2 As a result, parents may never be aware of

3 these child's elevated blood lead level, or of the

4 associated with damage.

5 Moreover, there is no way for parents to know

6 if a given object contains lead, so that they are

7 powerless to control the exposure or protect their

8 children.

9 It's the responsibility of the Commission to

10 provide that protection for children and families.

11 Risk assessment of individual products or

12 classes of products is impractical and subjective.

13 Some have recommended that the CPSC engage in some form

14 of risk assessment to determine the levels of lead

15 permitted in children's products.

16 From a medical perspective, the benefit of

17 lead exposure is zero. And so the considerable risk

18 will always outweigh the benefit of having lead in

19 children's products.

20 A risk assessment scheme would introduce

21 tremendous levels of subjectivity into this process and

22 remove any certainty for parents and caregivers about

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1 the safety of the items they purchase.

2 CHAIRMAN TENENBAUM: Your time has expired, so

3 if you'll just wrap it up quickly. Thank you.

4 MS. BEST: Okay.

5 There's two other points. Lead limits should
6 be based on total rather than accessible lead levels.

7 And the CPSC, as you've been doing, should collaborate

8 closely with companies working to comply in good faith.

9 In conclusion, I appreciate this opportunity

10 to offer these comments, and we urge the Commission to

11 continue placing the highest priority on protecting

12 children from lead exposure and its consequences.

13 Large numbers of children's products currently

14 on the market already comply, and we encourage you to

15 work with companies to make sure that all products

16 comply.

17 Thank you very much. And we can answer

18 questions in any way.

19 CHAIRMAN TENENBAUM: Thank you. Thank you

20 very much for that excellent presentation.

21 Are there any questions? Oh, I'm sorry, we're

22 not going to have questions individually. Thank you

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1 for reminding me.

2 Don Mays from Consumers Union.

3 MR. MAYS: Good morning, Chairman Tenenbaum

4 and Commissioner Nord, Commissioner Northup,

5 Commissioner Adler and Commissioner Moore.

6 Thank you for the opportunity to discuss the

7 proposal to lower the lead limit on children's products

8 to 100 parts per million.

9 My name is Don Mays, and I'm the Senior

10 Director of Product Safety and Technical Policy for

11 Consumer's Union, the non-profit publisher of Consumer

12 Reports.

13 And I offer my comments today on behalf of

14 Consumer's Union as well as on behalf of the Consumer

15 Federation of America.

16 Now let's be clear on one thing. There is no

17 safe level of lead exposure. And my colleague, Dr.

18 Best here has gone through the health effects, and I'm

19 not going to repeat that.

20 But it does have a tremendous economic burden

21 on society also, in the tens of billions of dollars.

22 We must do whatever we can to eliminate our children's

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1 exposure to this harmful toxin.

2 Now unfortunately, lead is ubiquitous in the

3 environment. We've used lead in paint, we've used lead

4 in plumbing, we've used lead in gasoline. And as a

5 result, we find traces of lead in our air, in our
6 water, in our soil.

7 But that doesn't mean that a manufacturer

8 can't control for it in the process of manufacturing

9 products, and manufacture children’s products in

10 particular with very low levels of lead.

11 And any intentional addition of lead into a

12 product should not be permitted; nor should

13 inadvertently addition of lead into products because of

14 poor quality control practices or poor selection of

15 materials that go into the manufacture of products.

16 Now I'm going to offer some evidence of why we

17 believe it is technologically feasible to reduce the

18 lead limit in children's products to 100 parts per

19 million.

20 In 2007, Consumer Reports tested this toy

21 blood pressure monitor, that was made by Fisher-Price.

22 One of several samples that we tested had as many as

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1 10,000 parts per million of lead.

2 Now at the time it was sold, that toy was not

3 in violation of any federal regulation. However, since

4 that time, Fisher-Price has redesigned this toy blood

5 pressure cuff, and our subsequent tests have shown

6 levels at about 47 parts per million.

7 So certainly, Fisher-Price could do it.

8 In 2006, we also found several children's

9 vinyl lunch boxes that contained high levels of lead,

10 ranging from about 46 hundred parts per million to

11 11,000 parts per million.

12 And our tests proved that that lead could be

13 transferred to unwrapped foods.

14 Now since that time, we resurveyed the market

15 and we found that many of the vinyl lunch boxes on the

16 market today are labeled as 100 percent lead-free. And

17 indeed, our XRF screening, testing a few bags, we found

18 did not present any indication of lead in the those

19 vinyl lunch boxes.

20 And just last year, our tests also uncovered a

21 children's vinyl raincoat made by Cadorables, that

22 contained in excess of 1,000 parts per million of lead.

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1 And that was a level that actually exceeded CPSIA

2 regulations.

3 But when we purchased a new sample to check

4 our test, that same product we found was now labeled as

5 "lead-free." And indeed, our tests of the new sample
6 showed only trace amounts of lead in the new products,

7 in the order of about ten parts per million.

8 Now the manufacturer told us that they had

9 reformulated its vinyl products to comply with the new

10 provisions of the CPSIA.

11 Now in addition, the current regulations for

12 paint under the CPSIA have reduced the lead limit from

13 600 to 90 parts per million. And in fact, paint

14 manufacturers all comply with that new regulation.

15 Now lowering the lead limit on children's

16 products to 100 parts per million may require

17 manufacturers that do not have good quality control

18 practices to tighten up their processes.

19 Manufacturers need to be more careful in

20 selecting materials used in their products, and test

21 those materials before the product is manufactured.

22 Now new limits may, for example, prevent the

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1 use of a re-ground vinyl or electronic circuit boards.

2 And we believe that this would a positive result,

3 because reconstituted materials contain other toxic

4 substances, such as cadmium, which is currently not

5 regulated.

6 Now it's been argued that lead poses a hazard

7 only when it shown to be accessible and soluble in an

8 acid solution that simulates saliva or stomach acid.

9 We disagree. Since lead is not always

10 molecularly bound to the material matrix or substrate

11 in which it is used, it can be liberated as the product

12 ages, or is exposed to mechanical manipulation,

13 environmental ozone, and ultraviolet light.

14 That's why the CPSC worked with the

15 Window-Covering Safety Council more than ten years ago

16 to eliminate lead in vinyl window blinds, which were

17 found to liberate lead dust as a result of exposure to

18 sunlight and heat.

19 Now in fact, of the many samples of this

20 Fisher-Price toy blood pressure monitor that we tested,

21 the one that showed the highest level of lead was the

22 oldest one, and had been in use for two years.

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1 Now in addition, extraction or solubility

2 tests for heavy metals could be imprecise, having

3 widely variable results due to the time required for

4 extraction, agitation level, temperature, ambient light

5 conditions, and the solute-to-sample ratio.
6 From a compliance and enforcement standpoint,

7 it is far better to rely on the precise test results

8 afforded by the current emissions spectroscopy tests

9 widely used for lead testing.

10 Therefore, it's imperative that the regulation

11 continue to rely on total lead content, not just lead

12 that is accessible when the product is new.

13 In regard to detection limits and test

14 precision, some argument that the current test methods

15 cannot accurately measure lead at levels below 100

16 parts per million.

17 This argument is incorrect. Use of

18 conventional emission spectrometry tests, such as

19 atomic absorption or inductively coupled plasma, can

20 detect lead in the parts-per-billion range, magnitudes

21 lower than the proposed 100 parts per million limit.

22 Those procedures generally have a precision

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1 range of about one to five percent; therefore, with the

2 sample that measures 100 parts per million, for

3 instance, you would expect a standard deviation of no

4 more than five parts per million.

5 Another significant advantage of the current

6 test method is its ability to measure the levels of

7 several other elements present in the product at the

8 same time as measuring the lead levels.

9 In the future, should the CPSC write

10 regulations for the use of total cadmium or other heavy

11 metals used in children's products, the cost increment

12 to conduct testing for those heavy metals would be

13 negligible.

14 And in regard to cost, reducing the lead limit

15 to 100 parts per million will not have an impact on the

16 cost of testing.

17 The list price for lead testing by independent

18 labs in the U.S. is typically $60 to $100 per

19 substrate, and only $20 to $40 in Asia.

20 Those prices will remain unchanged, and that's

21 based on the information that I've received after

22 serving the major laboratories across this country.

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1 In conclusion, lead is an extremely potent

2 neurotoxin that can cause irreversible brain damage in

3 children. Reducing the level of lead in children's

4 products to 100 parts per million, as required by the

5 CPSA, is clearly technologically feasible.
6 And companies have already begun to comply

7 with the statute's mandates. And our testing has shown

8 that products previously containing high levels of lead

9 have now been redesigned so that they contain less than

10 100 parts per million of lead.

11 We also know that the fashion jewelry trade

12 association has acknowledged that crystals have been

13 introduced to the market, that would be compliant with

14 the new proposed regulation.

15 In addition, the current testing methods for

16 evaluating lead levels is sufficiently precise, because

17 it can detect lead in the parts-per-billion range.

18 Consumers Union and Consumer Federation of

19 America strongly believe that the 100-PPM lead limit is

20 both reasonable and technologically feasible, and we

21 encourage the Commission to implement this requirement

22 as soon as possible.

¶ Page 28

1 Thank you.

2 CHAIRMAN TENENBAUM: Thank you both.

3 And now we'll have questions from our

4 Commissioners as well as from the Staff.

5 Do any of you know of products that it will

6 not be technological feasible to reduce the amount of

7 lead in the product to 100 parts per million?

8 MR. MAYS: No.

9 In our experience, virtually all types of

10 products with all different types of substrates that we

11 have tested, we have found that many of them are well

12 below that 100 parts per million limit.

13 The ones that might be a little more

14 challenging might be things like crystals, but yet the

15 fashion jewelry trade association has introduced the

16 market crystals that are in compliance with that

17 100-PPM proposed limit.

18 CHAIRMAN TENENBAUM: Thank you.

19 MS. BEST: Our expertise is children, not

20 products.

21 CHAIRMAN TENENBAUM: I know, I was just asking

22 that just in the event that you may have had some

¶ Page 29

1 thoughts on it.

2 Commissioner Moore?

3 COMMISSIONER MOORE: (Off mic) I believe you

4 stated that recent studies show low levels of exposure

5 to lead caused proportionately greater harm to children
6 than high levels of lead?

7 Can you explain why that would be the case?

8 MS. BEST: Well, the increased loss of IQ

9 points is proportionately greater between one and ten

10 mcg/dl.

11 You continue to lose IQ points as it rises

12 above ten; but the increase isn't as -- it's lower per

13 increase, so the curve goes up and then kind of slowly

14 increases after it hits ten.

15 Did I -- you know, without pictures, it's

16 (laughing).

17 COMMISSIONER MOORE: Hmm, yes.

18 MS. BEST: Okay.

19 COMMISSIONER MOORE: Thank you.

20 THE WITNESS: Commissioner Nord?

21 COMMISSIONER NORD: Dr. Best, in your

22 testimony, which is very informative -- and thank you

¶ Page 30

1 for that -- you reference lead exposure, but you also

2 talk in terms of lead that is ingested.

3 First of all, could you please, if you haven't

4 already, submit the studies that you're basing your

5 testimony on to our Staff, so they can have the benefit

6 of that?

7 Since we get one question, I have a multi-part

8 question (laughing).

9 First of all, does the exposure route count

10 here? Ingestion versus handling, for example? And

11 with respect to ingestion, do all materials act the

12 same way when they're ingested? Let's start with that,

13 Part A of my question.

14 MS. BEST: So with children, just handling

15 stuff is not the issue.

16 COMMISSIONER NORD: Hmm.

17 MS. BEST: It's that they handle it and then

18 it goes in their mouths.

19 COMMISSIONER NORD: So it's --

20 MS. BEST: Yeah. And I assume that some small

21 quantity of lead dust is inhaled, so that would be

22 another route.

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1 COMMISSIONER NORD: Mm-hmm.

2 MS. BEST: No, I don't know of any studies

3 that have actually looked at that as a route.

4 Primarily, we're concerned about the mouthing

5 behaviors.
6 COMMISSIONER NORD: So it's the ingestion,

7 taking it into the mouth and swallowing it?

8 MS. BEST: Right, right.

9 COMMISSIONER NORD: Okay.

10 So there are a broad of children's products

11 out there, a less broad range of products that could be

12 ingested.

13 MS. BEST: You mean the product itself?

14 COMMISSIONER NORD: Yeah.

15 MS. BEST: Right.

16 COMMISSIONER NORD: Does this suggest that

17 maybe we should be looking at those products a little

18 bit differently?

19 For example, should we be treating a baby's

20 rattle in the same way as a bicycle?

21 MS. BEST: That's a challenging issue. And I

22 understand that's part of why we're here today.

¶ Page 32

1 COMMISSIONER NORD: Mm-hmm.

2 MS. BEST: The mouthing behaviors of children

3 are not limited to swallowing things. I mean, toddlers

4 put their mouths on everything --

5 COMMISSIONER NORD: I understand.

6 MS. BEST: And so removing a certain line of

7 products from safety concerns would lead us to a false

8 sense of security, because I have yet to enter a year

9 of practicing pediatrics, where I'm not surprised by

10 something a child has ingested, or gotten into trouble

11 with, because they come up with something new all the

12 time.

13 And so I'm sure they're putting their mouths

14 on the bicycle that's parked inside their apartment,

15 you know, or the tricycle that's parked inside their

16 apartment is probably more likely.

17 So there's examples like that that I point

18 out.

19 COMMISSIONER NORD: Mm-hmm.

20 So there's a bumper sticker out there that

21 says, "Please, I promise I won't eat my dirt bike."

22 MS. BEST: Mm-hmm.

¶ Page 33

1 COMMISSIONER NORD: And this is from a bumper

2 sticker from a group that wants to change the law.

3 So I guess you are saying that yes, indeed,

4 children could get lead exposure, and hence poisoning

5 or bad levels of lead from sucking on their handlebars
6 and from the spokes of the bicycles, handling --

7 MS. BEST: You know --

8 COMMISSIONER NORD: That's your testimony?

9 MS. BEST: There's a level of rationale that

10 leads from the sublime to the ridiculous.

11 COMMISSIONER NORD: Mm-hmm.

12 MS. BEST: One of the opportunities that the

13 CPSC has is through the CPSIA, is to determine where

14 the bright line ends and where it begins.

15 That's not why we're here, that's not why I'm

16 here today is to tell you what exceptions should be

17 made.

18 There is a route through the CPSIA to make

19 those exceptions.

20 And my concern is that you understand that 100

21 parts per million is a reasonable public-health-driven

22 level about which we are concerned.

¶ Page 34

1 COMMISSIONER NORD: And then finally, in your

2 testimony you suggest that we use creative and flexible

3 options to deal with the problems that industry may

4 have.

5 If you could submit for the record some

6 suggestions as to creative and flexible options that we

7 should consider, I'd be most appreciative.

8 Thank you so much.

9 MS. BEST: You're welcome.

10 CHAIRMAN TENENBAUM: Commissioner Northup?

11 COMMISSIONER NORTHUP: Yes. Thank you.

12 I'm also interested in getting the studies

13 that you had, and also whether or not they are

14 peer-reviewed.

15 But I'm also interested in how you distinguish

16 between the various things that affect a child's IQ.

17 For example, there is this recent article that was in

18 the paper about a huge new study about junk food and

19 diet, and the amount of -- they call it a

20 health-conscious diet;

21 But the fact that it said between the first

22 couple of years of age that it can affect their IQ up

¶ Page 35

1 to seven points, the question of genetics; the

2 questions you have on your own website, a study that

3 tobacco use, prenatally and the absorption of the

4 toxins in tobacco smoke can lower a child's IQ.

5 And so when you do a study, first of all we
6 know that if you took the same child on two consecutive

7 days, it's very unlikely that their IQ would test to be

8 identical.

9 There are just daily fluctuations.

10 But how do you separate out the kids that, you

11 know, you have two sets of kids, and one has, say, 1

12 PPD, and one has 8 PPD?

13 How do you separate out what the cause of a

14 7-point or a 6-point or a 3-point IQ? Is it a bad day

15 for one and a good day for the other? And I know if

16 you have many, many kids, you'd say, "Well, it

17 averages."

18 But we know that children who are on Medicaid

19 are the ones we most want to test, because we know that

20 they're most likely to live in an older part of the

21 city, where the gasoline fumes were, where the lead

22 pain is still existing.

¶ Page 36

1 But we also know that nutrition issues are

2 more important there.

3 And so I just wonder how you decide that it's

4 lead, and not the tobacco fumes, what they ate in their

5 early years, the -- anyway, how do you distinguish

6 between what the cause is and what their IQ would have

7 been, had they not been exposed to lead?

8 MS. BEST: So that's a multi-part question, a

9 multi-multi-part.

10 First of all, all the studies we rely on are

11 peer-reviewed.

12 COMMISSIONER NORTHUP: Okay.

13 MS. BEST: They are very-well-respected

14 studies. And we do very thorough examinations before

15 we select studies.

16 In terms of how you pull out individual pieces

17 that are associated with loss of IQ points, the wonders

18 of large population studies is how we do that.

19 We look at populations and compare groups of

20 that population. We're talking thousands of children,

21 not one or two, or even ten or 20.

22 We're talking usually thousands of children.

¶ Page 37

1 For instance, the NHANES studies, where a nationally

2 representative sample of children are examined, and

3 then they cut the slice of that group of children into

4 children with a known exposure to lead, with no

5 exposure to lead, with medium exposures;
6 And then take a look at the IQ points.

7 Most of the time, the studies are using such a

8 large sample, that you can assume that the second-hand

9 smoke exposure in all parts of the group is equivalent.

10 And you can also cut the same slice of

11 children or group of children into groups, based on

12 economics, for instance, Medicaid/not Medicaid; and

13 assume that all else is similar within a group defined

14 by Medicaid or not Medicaid.

15 So that if you had a group of Medicaid

16 children who lived in D.C., if large enough, they would

17 be similar to a group of children receiving Medicaid in

18 New York.

19 And so it comes down to the statistics. And

20 you know, without explaining the statistics here, you

21 would have to trust the studies.

22 COMMISSIONER NORTHUP: Yeah. I guess I

¶ Page 38

1 understand.

2 What I'm confused about is how you -- I mean,

3 for example, this new nutrition study that just was, I

4 think, published in the last day or two, that has a

5 huge number of children --

6 MS. BEST: Mm-hmm --

7 COMMISSIONER NORTHUP: It shows that, you

8 know, the difference in the nutrition accounts for

9 about a seven-point IQ difference.

10 And so just it's a little hard for me to

11 understand how, because we know exposure -- I was

12 looking at your-all's website -- you have a very

13 extensive website on lead contamination -- I noticed

14 that all through it, all you talk about, I mean,

15 entirely is reducing your child's exposure through

16 dust, through homes, through exposure to paint that has

17 lead in it, and so forth.

18 And so if the challenge, as you look at

19 differing causes of the impact on children, I do

20 believe that from the minute children take their first

21 breath, that the amount of stimulation they get, what

22 they eat, the amount of stress or lack of stress, that

¶ Page 39

1 all of those things do -- and maybe lead, yes,

2 certainly lead -- that all of those things have an

3 impact on a child's, not only their IQ, but their

4 ability to use that IQ through attention span issues

5 and so forth.
6 My question is: How in studies do we

7 differentiate between what those very small changes

8 are, and in the populations whether the cause was other

9 exposures, other failures, other needs?

10 And sometimes, what we know is, is that there

11 is a predominant, there is a reason that we invest so

12 much in this country in children that are in

13 disadvantaged situations, because we a lot more money

14 educationally, we a lot more money for health, we a lot

15 more money for these things;

16 Because we know that they are as a

17 population -- not as a single family -- but as a

18 population, more likely to struggle with their

19 nutrition, more likely to struggle with the amount of

20 stress, more likely to --

21 CHAIRMAN TENENBAUM: Commissioner Northup, we

22 need to wrap up the question.

¶ Page 40

1 COMMISSIONER NORTHUP: Okay, right.

2 CHAIRMAN TENENBAUM: Okay. Thank you.

3 You want to respond?

4 MS. BEST: Can I just?

5 So, yes, all of life is now multifactorial.

6 There is lots of different inputs and outputs.

7 But this hearing is about lead. And so, you

8 know, there a lot of factors that will affect the

9 ingestion of lead and that absorption of lead.

10 But we are talking about how much lead is

11 acceptable in children's products.

12 CHAIRMAN TENENBAUM: Thank you.

13 Commissioner Adler?

14 COMMISSIONER ADLER: Thank you very much. Dr.

15 Best, it's a real pleasure to hear your testimony.

16 People sometimes ask me, "How did we end up

17 with the 600 to 300 to 100 parts per million?" And I

18 think I'm looking at the group that is in large part

19 responsible for that.

20 So you're either the hero or that villains in

21 this play. And I certainly appreciate your testimony.

22 I guess the one thing I was reflecting on is

¶ Page 41

1 that since I have been involved in this whole field of

2 public health, lead has been on the front burner for

3 decades;

4 And it is my impression that I would like to

5 hear your reaction that maybe next to tobacco, but
6 maybe even more than tobacco, lead is one of the most

7 studied toxins in the world.

8 Do you have any sense about the number of lead

9 studies relative to other toxins? Say cadmium?

10 MS. BEST: Oh, I know that there are more

11 studies on lead than cadmium.

12 I mean, historically we've known about lead

13 since Roman times, if not before. So we can settle

14 that.

15 In terms of lead in tobacco, I actually, you

16 know, my other favorite issue is tobacco and

17 second-hand smoke exposure and ways we can reduce those

18 exposures.

19 And we find that actually the lead keeps

20 popping up, even against the background of

21 second-hand-smoke, as one of those preventable issue

22 that we have control over.

¶ Page 42

1 And if we can get a control over this, we've

2 improved the health of our nation and the world,

3 because our products end up other places.

4 COMMISSIONER ADLER: Well, by that I think

5 you're telling me that even though we're measuring lead

6 at very low levels, we have multiple, multiple studies

7 that tell us that there does seem to be this effect.

8 And I was also reflecting on the fact that

9 this legislation was enacted in August of 2008, and you

10 were reporting on these peer-reviewed studies, which I

11 gather at the time were cutting-edge studies about the

12 effects of lead, the most recent up-to-date studies on

13 lead.

14 And so I guess I'm just curious. Have there

15 been any studies since then that in any tended to

16 contradict --

17 MS. BEST: No --

18 COMMISSIONER ADLER: -- the studies that you

19 submitted, or in any way pointing in an opposite

20 direction?

21 MS. BEST: No. And you know, more studies

22 have been published since 2008 that continue to refine

¶ Page 43

1 what we know about low levels of lead and their

2 effects; but they continue to support the fact that

3 even at very low levels of lead, there are still

4 measurable effects that show harm.

5 COMMISSIONER ADLER: Thank you very much.
6 And I do have one question for Mr. Mays.

7 And I guess it's a starting point. Let me

8 express ignorance. You cite emissions spectroscopy,

9 and then on the next ¶ Page, it's emissions spectrometry.

10 Is there a difference between the two?

11 MR. MAYS: The same thing. We're talking

12 about what they call "AA"--

13 COMMISSIONER ADLER: Yeah --

14 MR. MAYS: Atomic absorption, or inductively

15 coupled plasma, which is ICP. It's just a standard

16 test method that's used around the world for detecting

17 heavy metals and the quantity of heavy metals.

18 COMMISSIONER ADLER: This is actually, for me

19 at least, the first time I'm aware of somebody talking

20 about "This is an alternative test to the XRF or to the

21 ICP."

22 Is this one that is more accurate? Is it one

¶ Page 44

1 that's more expensive? Is it one that's more

2 available?

3 I see you cite that. I wasn't clear whether

4 you used that in testing any of the examples that you

5 offered to us.

6 MR. MAYS: Yes, it's widely available, it is

7 widely used, been used for years. From when I started

8 as an engineer at my career in 1977, I was using it to

9 test heavy metals in motor oil.

10 And it had high precision back then. It's

11 even better since that time.

12 And currently the people that are testing for

13 compliance to the 300-PPM limit in CPSIA are using

14 emission spectrometry to actually do that

15 determination.

16 It is likely to be more accurate than XRF.

17 XRF right now is being used primarily as a screening

18 tool, but the proof of the pudding is actually what you

19 get from an emissions spectrometry test.

20 COMMISSIONER ADLER: And one last very quick

21 question, if I might.

22 You've cited some examples of materials that

¶ Page 45

1 pass. I was just at the toy fair, and a fair number of

2 manufacturers came up and said, "You know what our big

3 problem is? The problem isn't plastic. Our problem is

4 metal, glass, and ceramics."

5 Have you done any studies that convinced you
6 that for the vast majority of producers, the vast

7 majority of materials that are metal, glass, or

8 ceramic, there would be no major technological

9 challenge to meeting those requirements?

10 MR. MAYS: Well, I'd be reluctant to make a

11 general statement about the vast majority of

12 manufacturers that use those materials in their

13 products.

14 But in our experience and what we've looked at

15 in the laboratory, we have found products with each of

16 those materials that had extremely low levels, or trace

17 levels of lead.

18 CHAIRMAN TENENBAUM: Okay.

19 COMMISSIONER ADLER: Thank you very much.

20 CHAIRMAN TENENBAUM: Thank you.

21 Now Dominique Williams or Kris Hatlelid, our

22 toxicologists, do you have questions? Please. Kris?

¶ Page 46

1 MS. HATLELID: My name is Kris Hatlelid. I'm

2 a toxicologist in the Directorate for Health Sciences.

3 I have one question for each of you.

4 Dr. Best, could you share with us at another

5 time the analysis that you presented for the

6 300-part-per-million objects swallowed that would lead

7 to particular IQ loss and the 77.

8 So the assumptions, the modeling --

9 MS. BEST: Right, right -- Okay.

10 MS. HATLELID: Okay?

11 And Mr. Mays, so you've talked about the

12 analytical methods and the precision and the low

13 detection limits for those. Can you comment on the

14 sample prep side of analysis?

15 MR. MAYS: Well, it's absolutely critical that

16 good laboratory practices are followed in sample

17 preparation. I think that no matter what type of

18 testing you do, that that's absolutely indicated that

19 you need to do that.

20 If you're testing for let's say lead in

21 plastics, the plastics are normally ground up and then

22 dissolved in acid in total digestion and then run

¶ Page 47

1 through ICP to do a determination of the heavy metals.

2 But there are standard procedures for

3 following that. And I mean, that's just part of the

4 equation.

5 The other part of the equation is the fact
6 that the instruments you're using have to be

7 calibrated.

8 MS. HATLELID: So in your laboratories, you've

9 not encountered any particular difficulties with

10 materials?

11 MR. MAYS: Well, I can't say no. We actually,

12 there is one product which was a glass product that

13 contained cadmium on an applique on the glass.

14 And that was difficult to prep the sample for

15 testing.

16 MS. HATLELID: Okay.

17 CHAIRMAN TENENBAUM: Dominique? Hyun Kim, do

18 you have any?

19 Thank you.

20 Well, thank you for those excellent

21 presentations.

22 (Discussion was held off the record.)

¶ Page 48

1 CHAIRMAN TENENBAUM: We have to have time for

2 the panels to come up and sit down. So if you have a

3 question, go ahead.

4 Please, go ahead.

5 COMMISSIONER NORD: All right. Our next

6 panelist is scheduled for 11:10.

7 So Don, do I take it, from the answer to

8 Commissioner Adler's question, that you think that wet

9 chemistry is the appropriate test for testing lead in

10 both paint and substrates and that XRF should not be

11 viewed as a substitute for that?

12 MR. MAYS: Yes, that is our current belief. I

13 don't want to rule out the fact that XRF technology, in

14 fact, is developing, and in the future might be an

15 appropriate tool to be using for compliance testing.

16 But everything that I've seen so far says that

17 it's certainly an appropriate screening tool; but as a

18 compliance and enforcement tool, it doesn't have the

19 precision that we would like to have.

20 COMMISSIONER NORD: All right. Thank you.

21 You put some cost estimates in your testimony.

22 Again, if there is any detail behind those cost

¶ Page 49

1 estimates, it would be helpful to have that;

2 You know, were they done at your labs, or were

3 they done at CPSC, recognized third-party testing labs?

4 And secondly, were those on a per-test basis

5 or a per-product basis?
6 MR. MAYS: They're on a per-substrate basis.

7 COMMISSIONER NORD: So a per-test basis.

8 MR. MAYS: So yeah. And that is the result of

9 surveying four major laboratories across this country.

10 COMMISSIONER NORD: Okay. In CPSC-accredited

11 labs?

12 MR. MAYS: CPSC-accredited labs, correct.

13 COMMISSIONER NORD: Okay.

14 So are you telling us that in the U.S. for $90

15 and in China for $40, you can get a bicycle tested? Or

16 are you saying you can get a component tested to

17 determine if it has a --

18 MR. MAYS: A component.

19 COMMISSIONER NORD: Okay. Fine.

20 And then just a point of curiosity with

21 respect to the lunch boxes -- and this is a very small

22 point -- but if the lead was coming off inside of the

¶ Page 50

1 lunch boxes onto the food, then that would be an FDA

2 issue.

3 And I just do not know what the FDA limit is,

4 and did you talk to FDA about this?

5 MR. MAYS: Yes, we alerted both the Consumer

6 Product Safety Commission as well as the FDA about our

7 findings.

8 COMMISSIONER NORD: And the FDA limit is?

9 MR. MAYS: There was no action taken.

10 COMMISSIONER NORD: No, but how does the FDA

11 determine if there's a problem?

12 MR. MAYS: The FDA does a different type of

13 test, where they use, I believe it's like a vinegar or

14 acetic acid solution, that tries to draw off accessible

15 lead.

16 COMMISSIONER NORD: Okay. So --

17 MR. MAYS: And it's a guideline, but it's not

18 a regulation.

19 COMMISSIONER NORD: So for lead in food,

20 there's a guideline, not a regulation?

21 MR. MAYS: For the contact surfaces.

22 COMMISSIONER NORD: Out --

¶ Page 51

1 MR. MAYS: The contact surfaces, exactly. For

2 the contact surfaces, yes.

3 COMMISSIONER NORD: But wouldn't that be a

4 food additive?

5 MR. MAYS: No. I don't think they would
6 classify it as --

7 COMMISSIONER NORD: But that's what they told

8 us back when we were doing that.

9 And I just --

10 MR. MAYS: Well --

11 COMMISSIONER NORD: I was trying to remember

12 as you were talking about what a --

13 MR. MAYS: Yeah. We may have a difference of

14 opinion.

15 COMMISSIONER NORD: Okay.

16 MR. MAYS: But we wouldn't consider it a food

17 additive.

18 COMMISSIONER NORD: All right. Thank you.

19 CHAIRMAN TENENBAUM: Thank you.

20 Are there any other questions? Commissioner

21 Northup?

22 COMMISSIONER NORTHUP: This if for Dr. Best.

¶ Page 52

1 I noticed that you talked about ingestion of

2 lead. Are there studies that you can point to -- not

3 today necessarily, that you could offer to us about

4 saliva-testing?

5 In other words, the difference between saying

6 biting off a piece of handlebar and having it in your

7 stomach and hung up for two days, as opposed to, like

8 you said, licking a tricycle or a bicycle handlebar?

9 MS. BEST: We can show you in-vitro studies,

10 where in a laboratory the acidity of saliva was used;

11 but those studies on children have not been done,

12 because just the ethical issues around them.

13 You know, we can certainly point to some case

14 reports, where we believe that children were mouthing

15 products. But they don't have the same quality as

16 these large-scale studies.

17 COMMISSIONER NORTHUP: Yeah. I'm looking for

18 studies, because that's of course, what we are talking

19 about is, I think we all know that a lead charm is very

20 serious.

21 COMMISSIONER NORTHUP: Mm-hmm.

22 MS. BEST: But as we make the rules and so

¶ Page 53

1 forth, I mean, discretion is part of our

2 responsibility.

3 And so if there is a difference between the

4 lead that's ingested, say, by a child that plays a

5 brass instrument, that puts her mouth on it, that puts
6 her hands on the brass instrument;

7 You know, may lick their finger and wipe the

8 mouth, I mean, the question is --

9 MS. BEST: There aren't going to be studies

10 like that, because you're not going to have enough

11 children of the same age to make a statistically

12 significant sample.

13 COMMISSIONER NORTHUP: So, but --

14 MS. BEST: What we can do, we can give you

15 studies of laboratory models, where we looked at

16 saliva, you know, fake saliva, that has the same

17 properties of saliva that's produced in your mouth, and

18 comes in contact with these kinds of materials.

19 So that's as close as we're going to get

20 without doing human studies, and no one's going to do

21 the human studies.

22 COMMISSIONER NORTHUP: Mr. Mays, the question

¶ Page 54

1 about the brass instruments, the statement in your

2 second paragraph about "There is no safe level of

3 lead," do you think that children that in the third and

4 fourth grade should be prohibited from playing brass

5 instruments, considering the lead content of that

6 brass?

7 MR. MAYS: I think children should not be

8 exposed to lead unnecessarily. And children in the

9 third and fourth grade -- I have a daughter in the

10 fourth grade, and I certainly wouldn't want her to be

11 exposed to lead, if that was coming from an instrument.

12 COMMISSIONER NORTHUP: So you would not let

13 her play like the horn?

14 MR. MAYS: I would be very concerned about

15 that, that's for sure. And she does not play the horn,

16 she plays the violin.

17 (Laughter.)

18 MS. BEST: The mouthpieces on most of those

19 instruments are not brass.

20 COMMISSIONER NORTHUP: Oh, yes, exactly. But

21 they were holding the --

22 MS. BEST: Right --

¶ Page 55

1 COMMISSIONER NORTHUP: As we know, they sling

2 them around and hold them, and they usually, if they

3 rent one -- I mean, my child that had one, they not

4 only rented one for school, but since they had to

5 practice a half an hour every night, they rented one
6 for home.

7 And so, you know, they could practice at night

8 and play it every day during class.

9 And that would be an every-day exposure, and I

10 just wondered if that would alarm you.

11 (Discussion was held off the record.)

12 MS. BEST: Well, again, it would alarm me that

13 children are exposed unnecessarily to lead. And

14 that's, again, the responsibility of the CPSC to

15 determine, to look at the studies on individual cases.

16 I'm here to talk about the harms of lead to

17 children and how they need to be protected.

18 COMMISSIONER NORTHUP: And I agree with you.

19 Ingestion of lead is very dangerous. I don't want to

20 diminish that at all.

21 CHAIRMAN TENENBAUM: Okay. Thank you very

22 much, Dr. Best and Don Mays, for the excellent

¶ Page 56

1 presentations. We appreciate all the preparation and

2 your coming here to testify to us this morning. It's

3 very helpful.

4 And now we will bring our next panel forward.

5 MR. MAYS: Thank you very much.

6 (End of Panel No. 1.)

7 CHAIRMAN TENENBAUM: Hi. Everyone is here.

8 And so we'll go ahead and start earlier.

9 Stan, if you will just go down and introduce

10 yourselves and then tell us the company that you're

11 representing, and just let us know your background.

12 Stan?

13 MR. PIOREK: Good morning. My name's Stan

14 Piorek. I am representing here Thermo Fisher

15 Scientific Portable Element and Analysis Group.

16 I work there as the Director of Applied

17 Research. Also I spent pretty much all my career in

18 developing XRF technology in portable and hand-held

19 issues, application-wise.

20 And I participate in standardization bodies

21 throughout, such as ASTM, IEC, International

22 Electrotechnical Commission, setting up standards in an

¶ Page 57

1 environmental domain like ROHS/WEEE, and so forth.

2 CHAIRMAN TENENBAUM: Mr. Gandhi?

3 MR. GANDHI: Hi. Thank you.

4 My name is Sanjeev Gandhi. I'm with the SGS

5 Consumer Testing Services based in New Jersey. I am
6 the Technical Director for Consumer Testing and the lab

7 operations in USA.

8 Thank you.

9 CHAIRMAN TENENBAUM: Thank you.

10 Mr. Bush?

11 MR. BUSH: Thank you.

12 My name is Milton Bush. I am the Chief

13 Executive Officer with the American Council of

14 Independent Laboratories, as well as the Executive

15 Director of the Americas Committee of the International

16 Federation of Inspection Agencies.

17 I have a law degree from George Mason

18 University, as Certified Association Executive. And

19 the areas of the my work in the past 20 years have been

20 in the areas of testing association.

21 CHAIRMAN TENENBAUM: Thank you.

22 Quin?

¶ Page 58

1 MR. DODD: Quin Dodd with Mintz Levin law firm

2 in Washington, representing today XOS; and my

3 colleague, Satbir Nayar.

4 CHAIRMAN TENENBAUM: All right.

5 Mr. Piorek, do you want to start with your

6 Powerpoint?

7 MR. PIOREK: Okay. Thank you for that.

8 And I'd like to thank you, Ms. Chairman and

9 Commissioners Nord and Northup, Adler and Moore, for

10 letting me be here and offer comments.

11 Today I'd like to provide you with our vision

12 of feasibility of meeting the 100-PPM lead. And I'd

13 like to address three major points associated with

14 that.

15 So first of all, the answer, whether it's

16 feasible or not from the point of view of testing, the

17 answer is a very sound "Yes."

18 In the majority of cases, majority of

19 matrices, XRF can easily analyze quantitatively 100-PPM

20 lead, as well as other elements.

21 Where we will have some problems are metals,

22 as it was pointed out earlier. Metals do tend to be

¶ Page 59

1 more absorbing medium for X-rays, and therefore

2 detection limits for, say, lead in such a matrix as

3 solder, tin solder, will be only on the order for

4 100-120 PPM.

5 And having said that, I would also point to
6 the fact that alloys as such are not necessarily the

7 majority of children's products or toys, and therefore

8 still doesn't prevent XRF to be used for screening

9 purposes to weed out our major violations there.

10 As a matter of fact, we have a very large

11 number of hand-held XRF deployed, and the Commission

12 uses them as well in their screening efforts.

13 And the other issue I'd like to point out here

14 is cost effectiveness of the exercise.

15 When we're talking about testing, it always

16 brings to mind: "How much does it cost?" And

17 depending on how much does it cost, the testing will or

18 will not succeed in overall picture.

19 So here, I brought you a table, which shows

20 cost of the trigger pool, as we call it, because our

21 instruments work that way, that when you pull a

22 trigger, the analysis commences, and the results are

¶ Page 60

1 displayed within 30 to 60 seconds.

2 And the results are also given for more than

3 one element, if needed.

4 And when you look at the cost of ownership of

5 the instrument, and the number of tests that you can

6 perform, you can easily come to the conclusion of how

7 much does it cost you, one analysis.

8 It's on the order of a fraction of a dollar,

9 in the least favorable case, at least, as we have here,

10 for a $25,000 instrument.

11 Now when we look at that, let's ask ourselves,

12 "What would happen if we didn't do this this way, but

13 sent stuff that we need to test" -- if I may use that

14 word -- "to the lab?"

15 If we do that, then as we heard before, my

16 predecessor, you pointed out some number, and I'm happy

17 to hear that confirms our findings about single

18 analysis of the substrate would vary from $50 to $75.

19 That's per one element or more, but it's one

20 substrate, one substance.

21 Now of course, if we talk about plastics,

22 alone, we know that labs which have XFR analysis

¶ Page 61

1 capability, they can do it for much less, for $10 an

2 analysis.

3 But in the general sense, this is what we face

4 as a consumer or manufacturer or distributor.

5 So then typically I don't see a situation when
6 we have only one kind of component in any object to be

7 tested; there's always a number of them.

8 And let's assume it's ten. If we do the math,

9 it would come quickly to the conclusion that to test

10 one product, it costs us on the order of $500.

11 So should we have spent $25,000 on tests, we

12 would only be able to do the test for 40-45 pieces of

13 different products;

14 Whereas for the same amount of money, you can

15 get ownership of the analyzer, with which you can

16 perform many more orders of magnitude more tests.

17 So that's on the cost effectiveness issue.

18 And don't forget, please, the fact that we to

19 give a multi-element analysis here, and let's don't

20 also forget about our time factor here.

21 This is spontaneous, and on this part you can

22 make a decision. So there is no delay, which also

¶ Page 62

1 contributes to better compliance.

2 So the third point I'd like to make here is

3 that I see the situation right now -- or let's say we

4 see it this way -- that we have plenty of sharks. And

5 let's say those sharks represent our violators, in

6 terms of products containing a lot of lead.

7 And we try to fish them out.

8 If we do that, we are facing some problems

9 here of logistics. Our practice -- and perhaps CSPC

10 also can verify that for us -- the majority of

11 violations occur with products, which have really very

12 high lead levels.

13 My predecessor here says himself it's not just

14 PPM lead, they are percent lead.

15 So when you see that it is simply not even

16 prudent to think, "Why spend effort?" It's a waste of

17 effort and money here to test gross violation with very

18 sophisticated methods, and also costly;

19 Sophisticated because it's accurate and

20 precise. But at the same time, it bears some higher

21 cost.

22 So we think that this vast net, vast fishing

¶ Page 63

1 net, very widespread, is this hand-held XRF, portable

2 XRF, with which we can weed out, catch up those big

3 violators.

4 And of course, lab techniques are there to

5 help us, we can -- I hate to use a military comparison
6 here -- but we could compare the hand-held XRF or

7 portable XRF to soldiers on the front line.

8 And if those soldiers cannot do the job, then

9 they call for reinforcements in terms of, say,

10 laboratory help.

11 Together, they are the best solution, because

12 they complement each other in a most effective way,

13 simply by providing a readily available method that can

14 be deployed anywhere. Test frequency will increase,

15 that of course, leads to better compliance.

16 If the cost of that test is also affordable,

17 that contributes to the better compliance as well.

18 So in the next slide, I would like to simply

19 show you this little strainer. This is rather a big

20 strainer, which tries to catch all those sharks.

21 And as you can see, many of them will fall in.

22 Some may escape, but then when you use small fish, that

¶ Page 64

1 with a fine mesh, but not as, you know, outreached as

2 the other, then, of course, we can -- a lot.

3 And this is what we don't want to, we want

4 this to be a very comprehensive approach.

5 So in summary, technically it's feasible, and

6 I think that the combination of both is the best way to

7 go.

8 And as it as mentioned earlier, progress in

9 XRF is still being made, even as we speak.

10 So these levels at this point right now are

11 not really an obstacle from the testing perspective.

12 And when we go in time in the future, we could

13 expect that the problem of lead sort of will start to

14 fade away, because manufacturers will eventually go

15 into better processes, cleaner processes.

16 What does that mean for testing? It doesn't

17 really change; it actually makes it easier. Because

18 it's much easier for any test method, XRF included, to

19 test homogeneous material uniform;

20 And then you won't see the differences between

21 performance, rather than test object, which is

22 finished, which is by design heterogeneous; and in

¶ Page 65

1 order to really test it, you have to destroy it.

2 And you find nothing there, then it's a little

3 bit too late, because it's still useless.

4 So I'd like to sincerely thank the Commission

5 for letting us speak. And if you have any questions,
6 I'm more than happy to address them.

7 Thank you.

8 CHAIRMAN TENENBAUM: Thank you very much.

9 We'll hear now from Mr. Gandhi.

10 MR. GANDHI: Just a second. I'm opening the

11 presentation.

12 I want to begin by thanking Chairman

13 Tenenbaum, Commission Northup, Commissioner Nord,

14 Commissioner Adler and Moore for the opportunity to

15 visit here and offer some comments in the CPSC's

16 consideration of the 100-PPM rule.

17 I would like to offer some comments, which are

18 kind of related to some of the discussions we had

19 earlier this morning about the variability of the data,

20 as well as certain materials that are more, perhaps,

21 susceptible to being found positive for lead versus

22 other types of materials.

¶ Page 66

1 Before I begin, I want to acknowledge my

2 colleague, who's also here in the audience. And she

3 helped me with the analysis.

4 Her name is Christina Crimi. And she is here

5 in this room today.

6 Just regarding SGS, we are one of the leading

7 inspection verification and testing companies.

8 Just a brief history of the company itself.

9 This is part of the presentation. So I'm not going to

10 talk a whole lot about it.

11 So once again, thank you for the opportunity

12 to offer the comments regarding this important aspect

13 of the technological feasibility of the 100-PPM limit.

14 Analytical techniques do exist to detect lead

15 below 100 parts per million.

16 The various types of techniques have been in

17 place for many years, and as some of my colleagues here

18 on this table have mentioned.

19 And there are other techniques,

20 non-destructive type of techniques, being developed,

21 which not only have come a long way already but also

22 continue to evolve, which would help some of the issues

¶ Page 67

1 that especially with the cost and how fast those tests

2 can be done.

3 So I'll echo some of those points that were

4 already made by my colleague, Stan, here.

5 I would like to offer some analysis on the
6 statistical data analysis that we have done internally,

7 based on various products that we test in our lab.

8 I will be primarily talking about a study that

9 we did based on the data pulled from our lab, one of

10 the largest test labs that we have in Shenzhen, China,

11 where we selected 90,000 data points, and would like to

12 offer some of that analysis, based on that.

13 The analysis covered major types of children's

14 products. The Shenzhen lab I mentioned is primarily a

15 lab for toys and general children's products.

16 So most of the products from which this data

17 has been taken based on analytical testing done by CSC,

18 are children's products.

19 And before I get into some of the specifics of

20 the analysis itself, I just want to mention that there

21 are some limitations that kind of affect our

22 interpretation of the data.

¶ Page 68

1 Oftentimes, you know, at the routine part of

2 our business process, we do not have the detailed

3 developed material information provided to us.

4 So if the company would send us a product,

5 finished product, and sometime raw materials are

6 sub-assemblies of those components, and we asked to

7 test those components.

8 So the lack of developed material information

9 means that we can only look at the components in a more

10 or less generic way.

11 So the material types that we have

12 characterized as part of this analysis are generic. So

13 they're plastics, but we cannot really go ahead and say

14 "This is this type of plastic versus this type of

15 plastic."

16 So polypropylene versus ABS.

17 Similarly for metals, it's hard to test by

18 visual examination of the metal components, we cannot

19 tell whether this is a homogeneous metal part or

20 whether it has electroplating on it.

21 Sometimes it is there, but then we cannot

22 really characterize that type of electroplating and

¶ Page 69

1 then analyze on a basically same kind of situation.

2 Oftentimes, the material may not be exactly

3 homogeneous in nature. And it cannot be determined

4 just by looking at it visually.

5 There are sometimes limitations, again due to
6 the heterogeneous nature of the material, that if you

7 are using the CPSC-approved SOP for doing the test,

8 that the digestion may or may not be complete.

9 The labs makes the best practice decision

10 based on their experience, based on their experience,

11 using the type of acids that can be employed to fully

12 digest the material.

13 And it can be visually seen during the

14 digestion process itself, whether the material has

15 properly digested.

16 But some cases, it may not be feasible as

17 well.

18 So that may be another limitation.

19 In very few cases, particularly with a

20 substrate -- because we're not really focusing on

21 coatings for part of the discussion today, we are only

22 talking about lead limits in substrate -- however, in

¶ Page 70

1 some cases, with substrate also, there might be an

2 issue of sample size;

3 Especially when we are de-constructing a

4 finished product, which is very small to begin with,

5 and had multiple material types.

6 So just a little bit more detail about the

7 source of the data itself: A majority of the data, the

8 90,000 data points that I mentioned came from our lab

9 in Shenzhen.

10 The analytical data results were stripped away

11 from our customer information to preserve the

12 confidentiality. So we are only looking at the

13 analytical results.

14 The data was collected during the period of

15 April through July 2010. During that time, the CPSIA

16 mandated limits of 90 PPM for lead in coatings, as well

17 as 300 PPM lead rule in substrate was in place.

18 So those samples that were sent to our lab

19 were being subjected to those two requirements.

20 Well, this gives an overall summary of the

21 type of data that was collected and then segregated,

22 based on what exactly component was tested.

¶ Page 71

1 So as I said, 90,000 data points were included

2 in this analysis. The data came from the testing of

3 the components of the finished product.

4 There were materials that were part of that

5 product that were segregated. So by coating plastic
6 metal, glass and ceramics -- and as I said earlier,

7 these are material types that are very generically

8 defined -- the total number of corresponding samples of

9 each category of material type are mentioned. And then

10 we looked at the data for those that were found to be

11 lead-positive.

12 And the absolute number of those samples of

13 the materials are also listed. There were a total of

14 1,250 data points that were indicative of the positive

15 results, and that constituted about 1.4 percent of the

16 entire data set: 90,000 data points, 1.4 percent

17 corresponding to 1,250.

18 And we have given the same kind of

19 lead-positive breakdown for those distinct material

20 types.

21 In my next set of slides, I am going to

22 restrict my comments and discussion only for three

¶ Page 72

1 basic material types:

2 The metals, the plastics, and the glass and

3 ceramic.

4 I'm going to exclude, as I mentioned earlier,

5 the coatings issue; and then the others, which is

6 smaller, which is some textile materials, and some foam

7 materials, that were excluded because of the small data

8 set itself.

9 So this is a further delineation in the

10 material types, the lead content distribution across

11 those several material types:

12 Metals versus glass and ceramics, and

13 plastics.

14 And then we broke them down according to the

15 limits that are in place. And those are being

16 considered.

17 So in case of metals, only 2.2 percent of

18 those tested materials in the broad category of metals

19 had lead about 600 parts per million; and then 0.8

20 percent at between 300 to 600.

21 And as we see, those corresponding percentage

22 breakdowns for plastics and glass and ceramics are much

¶ Page 73

1 lower.

2 And this is kind of corroborated by some other

3 comments made earlier, specific to the plastics.

4 However, glass is another story. Certain glass, but

5 not all glass are created equal.
6 So a certain glass or glass materials are,

7 however, not found to be an issue.

8 Now if you look at the same data in terms of

9 only the lead-positive samples, these are out of those

10 1,250 data points, 805 data points are those

11 corresponding to these three substrate types.

12 And then we have broken down the lead-positive

13 results according to the limits.

14 So only for the positive samples, the biggest

15 percentage belongs to the metals. And as I would also

16 point out later, some of the variability within the

17 metals grouping is much broader, compared to the glass

18 and ceramics and plastics.

19 So if we, just based on the current limit of

20 300 parts per million, about 80 percent of the

21 samples -- or that materials I should say -- across

22 metals, glass, and ceramics, and the plastics, 80

¶ Page 74

1 percent of the positive samples fall above 300 parts

2 per million.

3 And it goes down significantly when the limits

4 go down to 100 and below 100, if they go down.

5 This is sort of like a graphical

6 representation of the same data, again based on the

7 full data set, across those three material types. Now

8 we are talking instead of 90,000 data points, we are

9 talking about 52,000-plus data points.

10 And so about three percent of the metals would

11 fail, based on this data set, the limits when at

12 they're at 300 parts per million level.

13 CHAIRMAN TENENBAUM: Mr. Gandhi, your time is up, so

14 we just need to wrap it up.

15 MR. GANDHI: Yeah. Sure.

16 Just, so this is, again, a graphical

17 representation of just the lead-positive results. So

18 80 percent of the materials fall outside the current

19 acceptable limits.

20 And if the reduction does take place to 100

21 parts per million, then 90 percent of the material will

22 fall outside.

¶ Page 75

1 Which also means that potentially with lower

2 limits, the lead-positive results can be reduced to 0.9

3 percent; that is, 0.9 percent based on the full data

4 set of 90,000 points, whereas it is currently at 3.2

5 percent to 0.9 percent.
6 And overall observation -- just the last

7 slide -- we're talking about the variability within

8 material types. The highest variability does exist in

9 the metals, ranging from 100 to 10,000 parts per

10 million.

11 The variability is lower for lead

12 concentration in glass and ceramics, and then plastics,

13 much lower level.

14 Plastics, the foam and rubber-like materials

15 show this is based on anecdotal information right now.

16 We don't have the statistical analysis, because again

17 limitation of the developed materials.

18 So it's based on our experience just by

19 visually looking at those plastics.

20 The foam and rubber-like materials show high lead

21 content, compared to solid plastics like the

22 thermoplastics, the polypropylene and the ABS.

¶ Page 76

1 And then glass and ceramics, those substrates

2 that have some kind of a shiny texture. And it's kind

3 of vague, I know;

4 But those types of glass surfaces that have

5 some kind of texture added to it through some coating

6 process would appear to have high lead concentration

7 versus plain, opaque glass surfaces.

8 Conclusion. General order of the materials

9 that meet 100 parts per million limits would be:

10 Plastics, then going down, glass, ceramics, and metals.

11 I think that will be the end of my comments.

12 Thank you.

13 CHAIRMAN TENENBAUM: Thank you very much. And

14 we'll be coming back to you with time for further

15 explanation.

16 Mr. Bush?

17 MR. BUSH: Well, good morning again, Madame

18 Chairman and distinguished members of the Commission.

19 I very much appreciate the opportunity to

20 appear before you today, to discuss the role of

21 third-party independent laboratories in the testing of

22 consumer products under your jurisdiction;

¶ Page 77

1 And specifically with regard to the

2 technological feasibility of testing children's

3 products for lead at current and potentially lower

4 regulatory limits.

5 Again, my name is Milton Bush, and I am the
6 CEO of ACIL, as well as the Executive Director of the

7 IFIA Americas Committee.

8 ACIL was founded in 1937. Next year we

9 celebrate our 75th anniversary. And please be on the

10 lookout for their invitation, Commissioners. It will

11 be a great celebration.

12 An independent laboratory is not affiliated

13 with any institution, company, or trade group that

14 might affect its ability to conduct investigations,

15 render reports, or give professional counsel

16 objectively and without bias.

17 ACIL's 150 member companies operate

18 approximately 1,000 facilities across the U.S. and

19 abroad. They range from one-person laboratories to

20 multi-disciplined international corporations, such as

21 SGS, employing thousands of analysts, risk management

22 specialists, consultants, and support staff.

¶ Page 78

1 IFIA is the trade association for inspection

2 agencies and conformity assessment organizations that

3 provide inspection testing and certification services

4 internationally.

5 The promotion of integrity is one of the

6 Federation's top priorities.

7 IFIA was founded in 1982 and members an

8 associate members include the leading testing and

9 certification companies from around the world.

10 They cover every field of inspection and

11 related testing, making IFIA's work and views truly

12 representative of the profession.

13 IFIA is a non-profit organization, it's

14 objectives are to review and where possible to improve

15 methods, standards, safety, procedures, and rules

16 observed by members for the benefit of members and

17 their clients.

18 And both websites of both organizations are in

19 the written testimony.

20 IFIA and ACIL members are involved in

21 virtually every aspect of public health, safety, from

22 testing drinking water and food, to make sure they are

¶ Page 79

1 safe for consumption, to ensuring that our nation's

2 armed forces have tools and weapons that will not fail

3 them when needed;

4 And yes, making sure that consumer products

5 are safe and compliant with federal and state
6 standards.

7 IFIA and ACIL promote excellence,

8 independence, professionalism, competency, and

9 innovation, when testing in this testing certification

10 community.

11 To that end, IFIA and ACIL are both effective

12 and meaningful accreditation and recognition programs

13 as the key factor in ensuring technical competency of

14 laboratories, that ultimately lead to repeatable,

15 reliable, and consistent test results.

16 The key distinction between IFIA and ACIL

17 members and other conformity assessment bodies approved

18 to perform third-party testing by CPSC, is

19 independence.

20 IFIA and ACIL members provide an objective

21 review of product safety and performance, free from the

22 economic demands of the marketplace, and internal

¶ Page 80

1 company pressures, because they have no financial

2 interest in the sale products.

3 This ensures the results of the evaluation of

4 products to meet the specified requirements related to

5 the safety and health of the environment and are free

6 from conflicts of interest and undue influence.

7 I would also recommend to the Commission's

8 attention a review of the IFIA guidelines, which

9 outline working procedures and professional standards

10 normally used by IFIA members when providing testing,

11 inspection, and certification services.

12 There is a link in my written testimony.

13 In addition to assuring that consumer products

14 meet CPSC standards and are otherwise safe for consumer

15 use, independent third-party testing by qualified labs

16 instills greater consumer confidence, we feel, and

17 results in the ready marketplace acceptance of those

18 products.

19 It is no accident, after all, that despite the

20 fact that the CPSC has issued a stay of enforcement for

21 third-party testing and certification of products to

22 several CPSC standards, including most recently

¶ Page 81

1 extending the stay for lead substrate in children's

2 products.

3 The majority of the majority retailers in the

4 U.S. continue to require third-party testing and

5 certification in order to place products on their store
6 shelves.

7 The focus of my testimony is limited to

8 technological feasibility of consistently and reliably

9 testing children's products to get 100 parts per

10 million substrate standard, a question on which IFIA

11 and ACIL members have expertise.

12 I claim no such expertise, but am willing to

13 entertain written questions from the Commissioners,

14 following the hearing, for any answers from our

15 memberships.

16 The test method most commonly used, employed

17 today to test for lead, as we've heard before, is the

18 very substrates of consumer products, is ICP

19 technology, sometimes referred to as wet chemistry.

20 ICP is an analytical technique used primarily

21 for the detection of trace metals. The primary goal of

22 ICP is to get elements to emit characteristic

¶ Page 82

1 wavelength-specific light, which can then be measured.

2 ICP was first employed in the early 1960's and

3 has since been refined and used in conjunction with

4 other procedures for extremely precise quantitative

5 analysis in a variety of commercial and scientific

6 applications.

7 ICP is employed today as state of the art in

8 analytical measurement of heavy metals in a variety of

9 contexts, and is recognized as such by several federal

10 agencies.

11 These include the testing of environmental

12 samples by two EPA standards: For the evaluation of

13 occupational hazards under NIOSH test methods, and for

14 the measurement of lead and other trace metals in

15 various alloys and fuels, according to numerous ASTM

16 test methods.

17 In short, ICP is the most widely used and

18 relied upon means of evaluating and guaranteeing the

19 quality of a wide range of products and substances well

20 beyond just consumer substances.

21 While there are several types of ICP

22 analytical test methods, they all had been demonstrated

¶ Page 83

1 in various contexts, and were performed properly to

2 achieve precision, reliability, and repeatability

3 capable of consistently determining lead levels at

4 below the 100-PPM in all widely-used consumer products

5 materials;
6 Including metal, plastic, glass, and ceramic

7 substrates.

8 There have been several inter-laboratory

9 studies, well known to the CPSC lab, and other

10 scientific staff, that have achieved analytical

11 results, well below the 100 parts per million lead.

12 These include the September 2008 Round Robin

13 Interlab Study, results of proficiency test methods in

14 plastics.

15 In addition to ICP, the CPSC has also

16 recognized use of X-ray fluorescence test methods to

17 detect lead in plastic substrates of consumer products.

18 The CPSC continues to review the expanded use

19 of XRF to other substrate materials and surface

20 coatings.

21 I would like to take a short time to

22 illustrate the importance of a solid framework on which

¶ Page 84

1 repeatable, reliable, consistent test results are

2 built.

3 The National Institute of Standards and

4 Technology National Voluntary Laboratory Accreditation

5 Program, also known as NVLAP, which I'm sure the

6 Commission is well aware of, accreditation program for

7 energy efficiency of lighting products is a good

8 example of an effective inter-laboratory comparison

9 program, also referred to as proficiency testing.

10 A single artifact with known characteristics

11 is shared among all labs in an accreditation program

12 for testing.

13 A robust analysis of the results of the

14 accreditors at NVLAP determine if a lab's results are

15 outside of the expected results; and if so, those labs

16 are required to provide corrective action.

17 Key features of such a program include testing

18 equipment calibration, standardized testing procedures,

19 instruction, and uniform method for reporting results.

20 Such a framework enables the program

21 administrators to determine the capability of

22 laboratories and the evaluation of products to test

¶ Page 85

1 methods specified in the standards.

2 Participation by laboratories and

3 inter-laboratory testing, or proficiency testing, is a

4 key requirement to maintain their accreditation.

5 When the CPSC determines the technological
6 feasibility for laboratories to test to a level of 100

7 PPM, it needs to rely on laboratory accreditation and

8 accreditation body recognition processes to meet the

9 sector-specific requirements under CPSC regulations.

10 As we have commented previously, we also

11 believe that the ILAC-MRA is a reasonable place to

12 start in determining which accreditation bodies are

13 qualified to perform the necessary accreditation.

14 It is very clear that there are still

15 substantial differences between accreditation bodies

16 that are recognized under this MRA.

17 In fact, there are different recognition

18 models currently in use and available to U.S.

19 regulators:

20 For example, direct recognition of

21 accreditation bodies, or a delegation of recognition

22 authority to a private sector entity.

¶ Page 86

1 The recognition adoption model is ultimately

2 the decision of the regulator, so long as it ensures

3 that the statutory or regulatory sector-specific

4 requirements governing the regulator as well as the

5 requirements of the National Technology Transfer and

6 Advancement Act.

7 Reliability, repeatability, and consistency of

8 test results is a by-product of efficiency testing

9 framework used to determine the technological

10 feasibility of the test methods and laboratory and

11 accreditation and recognition process that assess

12 technical competency.

13 ACIL and IFIA encourage the Commission to

14 consider how its current program may be further

15 strengthened by adjustment in these two areas.

16 Thank you.

17 CHAIRMAN TENENBAUM: Thank you very much.

18 Quin?

19 MR. DODD: Good morning, Madame Chairman, and

20 distinguished Commissioners.

21 CHAIRMAN TENENBAUM: Good morning.

22 MR. DODD: I'm Quin Dodd with Mintz Levin

¶ Page 87

1 again.

2 It's good to see you all familiar faces, and

3 it's an interesting experience to be on this side of

4 the dais.

5 (Laughter.)
6 MR. DODD: Satbir and I both appreciate very

7 much the opportunity to appear before you today.

8 I will be making some initial introductory

9 remarks, and then Satbir will address some of the more

10 technical issues of technological feasibility with

11 respect to the testing to 100 PPM, and the use of his

12 company's technology to do so.

13 We've of course, briefed you all individually

14 in the past about XOS's analyzer technology called HD,

15 or high-definition XRS, as well as the new ASTM test

16 method, F-2853-10, that was recently published for

17 quantification of lead in paint and other surface

18 coatings, as well as substrates.

19 First, Satbir and I would both like to thank

20 you personally, I guess, for your recent purchase of an

21 HD Prime XOS analyzer at the Gaithersburg lab.

22 He and I were both out there several weeks ago

¶ Page 88

1 to install that, and we're proud and pleased now that

2 it's being used by the Chemistry Division Staff to help

3 fulfill their important mission; although I'll look

4 forward to it being in the new lab in nicer surrounds

5 in the not-too-distant future.

6 If I may then, I'd like to offer you a brief

7 recap of where we are with respect to their technology,

8 and where we believe we are headed. And then Satbir

9 has a short Powerpoint presentation for you to, again,

10 talk about some of the technical aspects of this

11 technology.

12 Since we've briefed you personally just about

13 a year ago, a lot has happened. XOS developed a new

14 transportable version of its analyzers, called HD

15 Equity, that is as precise and reliable as the HD

16 Prime, but smaller;

17 It's not very small yet, but it's heading in

18 that direction.

19 Many more labs and manufacturers have acquired

20 and installed XOS instruments, since we've briefed you,

21 and are now using them to test and/or verify testing

22 for lead, cadmium, and other heavy metals, essentially

¶ Page 89

1 all of the ASTM F-963 regulated heavy metals, in a

2 variety of substrate and surface-coating materials.

3 Most importantly, though, as I mentioned, and

4 as Satbir will discuss in more detail, ASTM has

5 reviewed, completed, and published the final version of
6 a new standard test method for the quantification of

7 lead in paint and substrate, using "energy dispersive

8 X-ray fluorescence spectrometry, using multiple

9 monochromatic excitation beams."

10 You can see why Satbir has joined me today.

11 We believe the finalization of this method,

12 which was well over a year in development, paves the

13 way for wider industry regulatory acceptance and

14 regulatory acceptance of this alternative to

15 traditional ICP for lead and paint, and ultimately for

16 all regulated heavy metals in both paint and substrate

17 materials.

18 As you well know, Section 101 of the CPSIA

19 both establishes very demanding new lead limits in

20 children's products, but also directly contemplates

21 expanding the options that manufacturers and importers

22 have to test to these tough new standards.

¶ Page 90

1 While ICP or wet chemistry is currently the

2 only specifically referenced CPSC test method for the

3 quantification of lead in paint and most substrates,

4 HDXRF can give the Commission and consumers at home the

5 same or even greater level of confidence that products

6 using this technology are indeed in compliance with

7 these and possibly future heavy-metal limits.

8 I would also like to state for the record that

9 XOS is not now advocating and has never advocated for

10 or against that 100-PPM lead standard called for by the

11 CPSIA, or any other CPSC standard, for that matter.

12 Indeed, the company only entered this market

13 space after enactment of the CPSIA, because it

14 recognized the very limited options manufacturers and

15 others had had and currently have with respect to

16 testing for lead and other heavy metals in consumer

17 products.

18 XOS has been a long-time world pioneer in the

19 development of cutting-edge X-ray optic systems,

20 capable of screening out background noise that limits

21 the effectiveness of traditional XRF instruments.

22 It's commercialized this technology widely for

¶ Page 91

1 the petroleum industry to measure sulfur contents in

2 fuels in response to a number of EPA regulatory

3 mandates;

4 And then began to expand upon the wider

5 potential of this highly precise, non-destructive
6 affordable and easy-to-use technology for other

7 mandates around the world, obviously including CPSIA.

8 XOS is not asserting or anticipating that this

9 technology will eliminate traditional test methods,

10 like ICP and hand-held XRF screening, but what it can

11 do -- and in fact, currently is doing at major labs and

12 manufacturing facilities around the world -- is to

13 provide an additional option to firms seeking to either

14 verify their other testing programs, or to test

15 products in the first instance.

16 In my view, this is exactly the kind of

17 development that Congress envisioned and intended when

18 it enacted the tough new standards under the CPSIA.

19 Indeed, this type of approach, establishing a

20 very difficult regulatory standard and anticipating and

21 in fact welcoming technological developments to meet

22 that standard, is a recurring theme in regulatory

¶ Page 92

1 history.

2 And we believe that, in fact, this is an

3 instance where it's worked quite well.

4 And if I may speculate, I believe it's the

5 kind of development that you would like to see as well,

6 as Commissioners:

7 More testing options, cheaper, better, faster,

8 and non-destructive testing, and complete protection of

9 consumers.

10 The phrase, "win-win," is used a lot, but I

11 really can't think of a better situation, where it

12 would apply than this, with respect to the use of HD

13 XRF in testing consumer products.

14 Thank you again very much for your time. And

15 now I'd like to turn it over to my friend and

16 colleague, Satbir, after which we would be happy to

17 answer any questions.

18 Thank you.

19 (Discussion was held off the record.)

20 MR. NAYAR: Good morning, Madame Chairman and

21 Commissioners. Thank you for allowing me to speak.

22 My name is Satbir Nayar. I'm Product and

¶ Page 93

1 Marketing Manager for XOS for our Consumer Products

2 Group.

3 What I wanted to touch on today was to address

4 the precision of a new technique that we've been

5 talking about, as well as the new ASTM method and how
6 it relates to the feasibility of the 100-PPM limit.

7 First of all, with any analytical method,

8 particularly for quantifying or determining heavy

9 metals, the limit of detection is a critical aspect to

10 the precision of the instrument.

11 What I wanted to show you here was how this

12 new method pushes the envelope of XRF with much lower

13 limits of detection than have been available in the

14 past, and then how that translates into being able to

15 precisely quantify at or below the regulatory limits.

16 This kind of relates back to Don's comment

17 earlier about some of the new enhancements that may be

18 coming. And I guess what I wanted to reiterate is that

19 they're here today.

20 So the new method that Quin referred to is

21 known as ASTM F-2853-10, has a very lengthy name that I

22 won't repeat, since Quin already referred to it.

¶ Page 94

1 The key point is it's applicable to paint and

2 substrates, for the determination of lead with a new

3 type of XRF-based technology.

4 This was published in August of 2010, was

5 about a year and a half in the making, and it is

6 applicable for quantifying lead in substrates at

7 concentrations of 14 parts per million for plastics and

8 glass, and 66 parts per million for metals.

9 As my colleague, Stan, alluded to earlier,

10 metals are more of a challenge for X-ray-based

11 technologies than plastics are.

12 But the key point here is that these

13 applicable minimum ranges are well below the regulatory

14 limits.

15 Any ASTM method is generally initiated by

16 what's called an Interlab Study for generally a large

17 group of labs to use the technique on a variety of

18 samples;

19 And ASTM does statistical analysis of the

20 data.

21 In this case, this was an Interlab Study

22 completed in September of 2009. There were nine labs

¶ Page 95

1 that participated, which for an initial Interlab Study

2 is quite significant.

3 Those labs included NIST, New York State

4 Department of Health, several third-party test labs,

5 and manufacturers.
6 Tested a variety of samples. Coded, uncoded.

7 A variety of substrates that were regulated at the

8 time. And there was over a thousand measurements that

9 were the basis for the statistical analysis of this

10 method.

11 The data that came from those thousand

12 measurements was compared by ASTM to the expected

13 results of the sample, which generates what's called a

14 "bias," or which is kind of the accuracy of the method.

15 And it was determined that there was no bias.

16 I would like to point out that the wet

17 chemistry method does actually have a bias published in

18 the ASTM method of 5 percent, which generally means

19 that there can be an expected error before you get into

20 repeatability and reproducibility of 5 percent.

21 This is, as I understand it, due to the risk

22 of improper or incomplete digestion of the sample.

¶ Page 96

1 The other two statistical metrics that are

2 used for an ASTM method are repeatability and

3 reproducibility.

4 Very briefly, repeatability is the same

5 operator with the same machine, measuring the same

6 sample over and over again.

7 Reproducibility is the variation from one lab

8 to another lab, using the same instrument or the same

9 technique.

10 So the data that I have up here is from the

11 ASTM method, at 100 parts per million. The

12 repeatability of plastic and glass is 9 parts per

13 million, so less than 10 percent. For metal, it is

14 higher, it's at 33 parts per million, but still quite

15 low.

16 The reproducibility, as one would expect, is

17 generally going to be higher between labs, and is 23

18 for plastics and glass, and 46 for uncoated metals.

19 My final slide is: This Interlab Study was

20 performed a year and a half ago. This is a new

21 technology that is continuously being developed. XOS

22 is a highly innovative company that's full of mostly

¶ Page 97

1 Ph.D.'s and masters degrees people, much smarter than I

2 am;

3 And what I wanted to point out is with some of

4 the new generations of the technology and improvements,

5 how the statistics have improved dramatically. These
6 are based on actual certified reference materials.

7 So for example, a copper alloy with 58 parts

8 per million of lead, we're looking at a repeatability

9 of 11 parts per million, and a reproducibility of 14.

10 There's other data points on here for plastic,

11 as well, basically clearly demonstrating that well

12 below the regulatory limits, this method is precise,

13 certainly precise enough to accurately quantify and

14 confirm whether a products is in compliance or not.

15 Thank you.

16 CHAIRMAN TENENBAUM: Excellent presentations,

17 and certainly a great deal of technical information for

18 all of us.

19 I'm going to let our Staff go first, to make

20 sure that they get their questions asked.

21 Dominique or Kris or Hyun, do you have any

22 questions?

¶ Page 98

1 MS. KIM: I have a bunch of questions.

2 (Laughter.)

3 CHAIRMAN TENENBAUM: Okay.

4 MS. KIM: I understand that the main thrust of

5 your presentations have been regarding the

6 technological feasibility of actually testing materials

7 to the 100-parts-per-million content limit.

8 But I think more the focus of this hearing is

9 to determine whether there is a significant distinction

10 between the 300 parts per million and the 100 parts per

11 million lead content levels, and whether there's an

12 appreciable difference in your ability to test between

13 the 300 parts per million and the 100 parts per

14 million.

15 And I'd like to ask specifically about

16 Sanjeev's charts, in terms of how the materials break

17 down.

18 I can see from your chart here, that when you

19 tested over 90,000 data points, about half of them

20 resulted in testing of plastic, metal, and ceramic, if

21 you took out the coating.

22 MR. GANDHI: Mm-hmm.

¶ Page 99

1 MS. KIM: And out of that, I think you said

2 that there was only a small percentage of failures.

3 And most of the failures was over 600 parts per

4 million.

5 MR. GANDHI: Yes.
6 MS. KIM: Is that correct?

7 MR. GANDHI: Yes.

8 MS. KIM: So what that shows is that of

9 course, the 600 parts per million is no longer law.

10 That's a failure.

11 Over 300 parts per million is a failure.

12 So those are just outright failures.

13 MR. GANDHI: No. Those are based on only the

14 data set corresponding to the failed samples, our

15 positive samples.

16 MS. KIM: Right.

17 MR. GANDHI: So out of those -- that's not a

18 percentage calculated on the basis of 90,000 points.

19 Or, let me go back here.

20 So in case of metals, for example, the total

21 number of data points are 11,000. And out of those,

22 440 are corresponding to positive samples.

¶ Page 100

1 MS. KIM: Right.

2 MR. GANDHI: At a limit of 40 PPM and above.

3 That's what we characterized as positive, anything with

4 40 and above.

5 And so that corresponded in case of metals to

6 3.8 percent of the whole metal category of samples.

7 MS. KIM: Okay.

8 MR. GANDHI: Now in that 3.8 percent, 58

9 percent of those, if you look at the next shot in this

10 table here, of 58 percent, which is about, let's say

11 220 data points or so, which showed limits above 600.

12 MS. KIM: So of the metals that actually

13 failed, what percentage of the data set failed over 100

14 parts per million to 300 parts per million?

15 CHAIRMAN TENENBAUM: ¶ Page 7 of the --

16 MR. GANDHI: So this 58.64, and if you add the

17 one which is between 300 and 600, you know, roughly it

18 adds up to 80 percent of those 440 data points, that

19 are positive samples for metals.

20 Does that answer your question?

21 MS. KIM: Well, I'm just trying to figure out

22 what percentage of your data points --

¶ Page 101

1 MR. GANDHI: So that would be 220, so let's

2 say 220 based on 11,000 total metal substrates that we

3 tested.

4 MS. KIM: Mm-hmm.

5 MR. GANDHI: So that would quickly calculate
6 to around, let's say over 0.2 percent.

7 MS. KIM: Okay.

8 MR. GANDHI: So still significantly low in

9 terms of the overall data set.

10 MS. KIM: Right.

11 MR. GANDHI: You know, remember I said 1.4

12 percent of all the 90,000 data set corresponds to what

13 is a positive sample.

14 Which is adding up to 1,250 for the 90,000

15 data points.

16 MS. KIM: Okay. So in the bigger picture, I'm

17 trying to figure out, do you consider that a very small

18 failure rate?

19 MR. GANDHI: Yes.

20 MS. KIM: Okay.

21 And of the three categories, metals would be

22 the highest?

¶ Page 102

1 MR. GANDHI: Yes.

2 MS. KIM: And then plastics and then glass and

3 ceramics?

4 MR. GANDHI: That's correct.

5 MS. KIM: So you think that metals is fairly

6 small, and then plastics and glass are even less than

7 that?

8 MR. GANDHI: That's correct.

9 MS. KIM: Okay.

10 So in terms of when you're doing the testing,

11 do you see any trends that, when you test, that there

12 are fewer and fewer failures? Or do you see a constant

13 failure rate?

14 MR. GANDHI: Now, overall, I mean, one of the

15 I guess the limitations of this data set at this point

16 is: This was collected after the CPSIA limits of 300

17 parts per million for substrate was already set, was in

18 effect.

19 MS. KIM: Mm-hmm.

20 MR. GANDHI: So, and this is with the

21 implementation of a new -- system in our laboratory

22 that allowed us to call this data together.

¶ Page 103

1 Unfortunately, I don't have the historical

2 data going back maybe two years, from where I can pull

3 a similar data set that I can compare against today's

4 data set, and check a side-by-side comparison over the

5 years of two or three years, if there has been a
6 significant reduction --

7 MS. KIM: A trend --

8 MR. GANDHI: In terms, you know, that can be

9 characterized as a trend.

10 MS. KIM: Okay. One of the --

11 MR. GANDHI: But if you look at the CPSC's own

12 recall data, maybe you know, just as not a scientific

13 established fact, but just on an anecdotal basis, if

14 you look at the number of recalls the CPSC has done,

15 you know, in the last several weeks, several months, I

16 would say, I've not seen any recall associated with

17 lead.

18 MS. KIM: Okay --

19 MR. GANDHI: Compared to five or six years ago

20 or over the years.

21 MS. KIM: Okay. One of the issues that have

22 been raised is that there may be insufficient virgin

¶ Page 104

1 materials or other lead-free materials of sufficient

2 quantity and at a sufficient price to make children's

3 products, that would allow people to have

4 consistently-passing test results for these products.

5 Can you speak to what you know about materials

6 and material availability and in terms of quantity and

7 sufficiency for making products?

8 MR. GANDHI: Again, this is based on my, I

9 guess, experience in my previous life as a materials

10 scientist.

11 You know, I used to work primarily at that

12 time with polymers, you know. I mean, there is a

13 functional aspect of the addition of any kind of heavy

14 metal-based compounds.

15 So unless there are some issues relating to

16 the processing and the contamination issue.

17 But functionally there is no reason to add

18 lead, you know, in most of the products, at least for

19 plastics, you know, there had been, you know,

20 previously reasons for adding lead-based compounds for,

21 whether it's for durability purposes of thermal

22 stability, or in case of certain types of plastics with

¶ Page 105

1 pigments, certain pigments added a characteristic that

2 was needed.

3 But there have been substituted over the

4 years, you know, over the last ten to 15 years, there

5 had been substitutes developed that gave the same kind
6 of functionality, without having to add lead-based

7 compounds.

8 I cannot say the same kind of remark with

9 respect to some other substrate types, like metals and

10 glass and ceramics, because it's not in my area of

11 expertise.

12 CHAIRMAN TENENBAUM: Any further questions

13 from Dominique or Kris?

14 Dominique?

15 MS. WILLIAMS: I have a couple questions.

16 And this is mostly directed at Mr. Gandhi, but

17 anybody can answer this.

18 Comments show that there is concern about the

19 variability in the test results. What would you say

20 was the cause of this variability? And is this an

21 issue that the laboratories are actually concerned

22 with?

¶ Page 106

1 Anybody can answer, if you have comment on

2 that. But it was specifically for Mr. Gandhi.

3 (Discussion was held off the record.)

4 MR. PIOREK: Your question was related to

5 laboratory analysis, or?

6 MS. WILLIAMS: Laboratory analysis that the

7 test results --

8 CHAIRMAN TENENBAUM: The degree of variability

9 is what she's asking. In terms between laboratory and

10 laboratory.

11 MR. PIOREK: Okay. Well, there are several

12 issues here.

13 If you are asking or inquiring about the

14 variability from lab to lab, regarding of the metal

15 used, that is natural things to occur.

16 Because of the fact that there are always

17 different conditions in different labs, even you have

18 the same instrument, it's the same make of instrument

19 doesn't mean that instruments perform identically.

20 MS. WILLIAMS: Mm-hmm.

21 MR. PIOREK: So that's one reason.

22 And if you refer to discrepancies between

¶ Page 107

1 different techniques, that's still a different issue.

2 So I'm not sure which one you'd like to --

3 MS. WILLIAMS: Well, it's just in general,

4 because we had during our comment period we had many

5 comments that were talking about concern.
6 And just variability in their test results.

7 So whether that is inter-laboratory, intra-laboratory

8 variability, or lot variability, my point is: Is this

9 something that testing labs are concerned with?

10 And if so, where would they see that

11 variability coming from?

12 MR. PIOREK: Well, in this case, since I'm not

13 representing a laboratory, I would refer it to somebody

14 else, like my colleague on the left.

15 MS. KIM: Sure.

16 MR. PIOREK: But I will tell you also that

17 variability is inherent to measurement, any measurement

18 that we perform.

19 So in terms of laboratory variability, I would

20 refer that question to my colleague on the left.

21 MR. GANDHI: Yeah. In terms of the academic

22 principle, variability is inherent to the measurement.

¶ Page 108

1 How much variability? That's where, you know,

2 the main issue comes in.

3 Now, so the quantity of the variability, you

4 know, the "R" values that Satbir just talked about, you

5 know, the small "r" and the big "R."

6 You know, whether it's an interlab or

7 repeatability or intralab repeatability or interlab

8 reproducibility.

9 So within the lab, especially when you have

10 multiple steps to a measurement, ending up with a

11 measurement, the more the number of steps involved, the

12 variability, the chances of variability occurring are

13 more.

14 And it could happen, it could have a multi-R

15 effect.

16 And that's why, you know, when you start with

17 a simple step of weight measurement on a balance, the

18 precision level of that balance to your then in case of

19 the wet chemistry specifically with digestion step,

20 that again can produce a variability.

21 And materials themselves are inherently

22 variable. You know, they could be coming from

¶ Page 109

1 different lots, different places of production.

2 And although they may look like as a finished

3 product, they're the same product, but they're

4 essentially made of materials that different facilities

5 can produce at different facilities, assembled into the
6 finished product;

7 But looking at the product at the lab level

8 there is no way to distinguish it.

9 So there is inherent variability coming from

10 the material itself.

11 So there could be multiple factors that are

12 compounding through a multiple-R effect, leading to a

13 net variability in your data.

14 And you know, from the lab site, there are

15 controls in place to minimize whether through, you

16 know, proper SOPs being implemented, that your

17 digestion processes are controlled, your habit of

18 cross-checking your steps along the way;

19 Those are different controls that you put in

20 place in a laboratory environment in order to minimize

21 the variability that can be induced at the laboratory

22 level.

¶ Page 110

1 MR. NAYAR: I just wanted to add one thing.

2 The key to that is that the fewer steps you

3 have in your process, the less variability you're going

4 to get.

5 So some techniques have more steps involved,

6 and you've got human beings performing those steps. So

7 you are going to get variation there, even if, you

8 know, everything is done correctly.

9 So one of the key reasons why this new method

10 was developed is because there are less steps involved.

11 There is less sample preparation, so less chance for

12 error.

13 MR. RECHT: If I may -- I'm Joel Recht, the

14 Chemistry Division Director here at CPSC -- just to

15 follow up and sort of bridging the question, the two

16 previous questions:

17 Is there something in going from 300 parts per

18 million as the limit to 100 parts per million as the

19 limit, is there an area within that change that you see

20 interlab variability or within- lab a variability in

21 testing from one item to the next, to be a problem that

22 is different from at the 300 parts per million limit?

¶ Page 111

1 MR. PIOREK: So maybe we should go in a row?

2 Okay, from the perspective of XRF testing, the

3 difference between 100 and 300 is virtually nonexistent

4 in terms of let's say precision or accuracy of

5 measurement.
6 Your relative error of measurement will

7 increase when you go down. What I mean by that, let's

8 say we measured 300 PPM, and the error on that number

9 is, say 10 PPM. That relative error would be then,

10 1,000/300, would be like 3 percent relative.

11 All right.

12 When we go down to 100 PPM, the error of

13 measurement may still be at 10 PPM or even 8 or 9. So

14 the relative error will increase, but in terms of

15 absolute difference between the measurement at this

16 level is very insignificant.

17 The reason is because we already operate on a

18 very low concentration level and at that range, the

19 measurement doesn't change much from a level of say 100

20 to 300.

21 If we'd ask the difference say 2 percent and

22 100 PPM, then I would say, yes, there will be a

¶ Page 112

1 difference of a different nature.

2 CHAIRMAN TENENBAUM: Okay.

3 All right. We'll have a time to do follow-up

4 questions.

5 Oh, you wanted to --

6 MR. BUSH: I just wanted to make a comment,

7 that ACIL runs a proficiency testing program in one of

8 its sections.

9 And I can tell you that our laboratories take

10 these types of variations very seriously. That program

11 that we run is very structured.

12 And laboratories are repeatedly being circled

13 through the program to make sure that, you know, they

14 understand that if there is variability in test

15 results, that they are understandable and that that

16 calibration of the artifact and the equipment in the

17 laboratory is under constant review.

18 So if there is this kind of variability within

19 lab results, it will be discussed by our members in the

20 technical societies in which they participate.

21 CHAIRMAN TENENBAUM: Okay. Let's let the

22 Commissioners ask questions now.

¶ Page 113

1 First question I have I'm going to be asking

2 of everyone today is: Do you know any product that it

3 is not technologically feasible to reduce it to 100

4 parts per million?

5 MR. PIOREK: May I?
6 CHAIRMAN TENENBAUM: Yes.

7 MR. PIOREK: From my, or say our perspective,

8 the reason I want to say something to that effect is

9 because XRF is used predominantly or has been

10 historically for alloy analysis;

11 So therefore I know a little bit about alloys,

12 even though I'm not a metallurgist, per se.

13 There are alloys that contain lead for a

14 reason. You may have stainless steel, with 0.3 percent

15 lead added to it, for machinability.

16 In other words, when you put the tool to this

17 material, the tool lasts longer and also machines

18 better, the alloy.

19 We talked about the brass instruments here.

20 Well, you'd be surprised if you go back in history, the

21 best organs that you find in churches are made of

22 bronze, which has a lot of lead in them.

¶ Page 114

1 And the reason for it is that it then gives a

2 better sound.

3 And the same goes for brass instruments

4 (laughing). So that's the reason that sometimes lead

5 is there, and I don't know whether there are any

6 efforts to replace it.

7 But it has a functional role there. Okay?

8 And we had the ROHS regulation in place for two or more

9 than two years now. And we know that lead in solders

10 have been limited to very, very low concentration.

11 That caused some problems, because the lead

12 was there also for functional reason to improve

13 wetability of the alloy.

14 And that's how some of those alloys, some of

15 brasses, some of bronzes that you find, probably in

16 bicycle you will find some brass parts, as bearings,

17 and they may have some lead;

18 But it's not contamination. It's a functional

19 role that it has to fulfill.

20 CHAIRMAN TENENBAUM: It has a functional

21 purpose.

22 MR. PIOREK: Like lubrication, lubricating,

¶ Page 115

1 for example.

2 CHAIRMAN TENENBAUM: Mm-hmm.

3 MR. PIOREK: Thank you.

4 CHAIRMAN TENENBAUM: Thank you.

5 Any other comments on that?
6 MR. GANDHI: Yeah. I would concur with the

7 comments made by Stan.

8 There are some functional aspects to the

9 addition of lead in certain types of materials,

10 metallic parts in particular, and which at this point,

11 technologically may not be feasible for the same kind

12 of cost in the production of them.

13 You know, mentioning about the ROHS you know,

14 over the 4 years of implementation, you know, the

15 number of parts including the solders that have

16 technologically been developed to replace solders which

17 had lead in it, there has been a tremendous improvement

18 in that.

19 So the technology continues to evolve. So I

20 am confident there is over time quite a good

21 possibility of that technological improvement in that

22 area would also allow the industry to come up with

¶ Page 116

1 replacements that right now seem insurmountable.

2 CHAIRMAN TENENBAUM: Thank you.

3 Any other comments?

4 (No response.)

5 CHAIRMAN TENENBAUM: Thank you.

6 Commissioner Moore?

7 COMMISSIONER MOORE: No.

8 CHAIRMAN TENENBAUM: Okay. Commissioner Nord?

9 COMMISSIONER NORD: Yes.

10 Mr. Gandhi, with respect to your results, to

11 what extent were recycled metals involved in the

12 materials that you tested for? And were you able to

13 track, if they were there, whether there was any

14 correlation between passing and failing?

15 MR. GANDHI: Yeah.

16 COMMISSIONER NORD: I mean, is use of

17 recycling something that we need to be concerned about?

18 MR. GANDHI: This is not something we have

19 really conclusively ironed out through our data.

20 You know, I mentioned the limitation with the

21 lack of developed material information.

22 So after we, you know, overall based on the

¶ Page 117

1 90,000 data points, we come up with 3.8 percent metal

2 parts, which are lead-positive.

3 Then we started to look at them sort of

4 individually, those 440 parts that were a set of fail

5 samples.
6 And although we did not have the comprehensive

7 material information, based on our engineers and

8 chemists in the lab, you know, a technical team, they

9 started to look at them.

10 So this work is, I would say, still in

11 progress.

12 You know, just based on, in quantitative terms

13 the variability size, meaning by a factor of 100, we

14 have lead-positive samples in metals, going from 100 to

15 10,000 parts per million, which definitely does suggest

16 there is, you know, a broad variety of materials, and

17 some of them may be those which are made with recycled

18 materials.

19 All metallic but recycled materials.

20 And that's one of the issues that has been at

21 least pointed out in some of the industry sector also,

22 that purity of the materials, metallic materials, is

¶ Page 118

1 not sometimes living up, even in some cases where what

2 is called a certificate of analysis is available.

3 So that issue is perhaps a very valid issue.

4 But right now we don't have the conclusive evidence,

5 based on our limited data set to say anything that

6 would bear on my comments.

7 COMMISSIONER NORD: With respect to the two

8 companies that make the XRF technology, I was very

9 interested in the new ASTM standard, which apparently

10 allows for this technology to test for both lead and

11 paint, and in substrates.

12 As we work through these issues and anticipate

13 the stay of enforcement being lifted in December, and

14 start accrediting laboratories, should we be looking at

15 XRF technology as a screening tool, or does the ASTM

16 standard tell us that we could be just basically

17 relying on this technology beyond screening and for

18 absolute results with respect to our enforcement

19 activities as well?

20 MR. DODD: If I may, short answer is for

21 traditional or hand-held XRF, the answer is no. For

22 the new method, 2853, the answer is yes.

¶ Page 119

1 And I'll allow my colleagues to elaborate.

2 MR. PIOREK: In terms of XRF as such, you have

3 energy-dispersive XRF technology on the market for a

4 long, long time;

5 And this technology, as a lab-based
6 instrumentation, it would address the issue of

7 quantitative analysis at that level, quite respectably;

8 Because once you prepare a sample in the same

9 way like you would do for ICP, or any other wet

10 techniques, you are dealing with a homogeneous medium,

11 which of course, is not exactly what the object has

12 been before you converted it to this;

13 But if you compared, then, the accuracy,

14 precision, then you will see hardly any difference

15 between the ICP or wet method, as opposed to XRF.

16 But I'm referring laboratory-based XRF

17 methods.

18 In terms of hand-held, currently hand-held are

19 considered to be screening tools. And that's all

20 right. It is a screening tool, very effective;

21 Although progress is made to improve the

22 performance so it can reach, you know, also the level

¶ Page 120

1 of acceptance that it would be used for solely

2 quantitative analysis.

3 I would qualify hand-held as semi-quantitative

4 in certain cases, but most of the time, because of its

5 deployment, it's used as a screening tool. Yes.

6 COMMISSIONER NORD: And then, Mr. Nayar, I

7 just wanted to make sure I was interpreting your slides

8 correctly.

9 Going to the questions that the Staff asked

10 about variabilities between testing laboratories, are

11 you saying here on your slide that the reproducibility

12 at 100 parts per million -- and by reproducibility you

13 meant between laboratories -- for uncoated metals,

14 there would be a difference of 46 PPM.

15 Is that the correct interpretation, then for

16 testing?

17 MR. NAYAR: Correct. I mean, yeah.

18 COMMISSIONER NORD: Okay.

19 MR. NAYAR: Basically, you know, statistically

20 it's that 95 percent of the time, you know, if two

21 different labs measure the same material, it would be

22 within that range.

¶ Page 121

1 COMMISSIONER NORD: Within basically a 50

2 percent range?

3 MR. NAYAR: Well, if you want to look at as a

4 plus or minus, you'd cut it in half.

5 COMMISSIONER NORD: Yeah.
6 MR. NAYAR: I'm technically that's not what

7 gets done. But yeah.

8 COMMISSIONER NORD: Okay.

9 So there is at that very, very low level,

10 there is variability between the labs. Again, it's a

11 very low level.

12 But relatively it's 46 percent. Okay.

13 MR. NAYAR: Yeah. But I do want to reiterate

14 that that was on a, you know, method before it was

15 being developed on very early technology of the

16 equipment.

17 COMMISSIONER NORD: Mm-hmm.

18 MR. NAYAR: And the reason I put the next page

19 up is to show how that number has gone down in that

20 year and a half from the standpoint of improving the

21 technology and the calibration.

22 And a key point here is that reference

¶ Page 122

1 materials are not all that common at this level. So as

2 you know, there are no lead in paint reference

3 materials on the market today.

4 COMMISSIONER NORD: Yes.

5 MR. NAYAR: In a few months, NIST will be

6 hopefully releasing those.

7 And then that starts to factor into the

8 calibration and the validation of the technologies to

9 get those numbers down even further.

10 COMMISSIONER NORD: Okay. So there will be

11 variability, we should understand we're dealing at

12 teeny, tiny levels.

13 MR. NAYAR: Yes.

14 COMMISSIONER NORD: And the variability at

15 those levels may be significant within those levels,

16 but it is going down.

17 Am I getting the sense of it?

18 MR. NAYAR: Correct. Correct.

19 Yeah. And the key thing here is again, the

20 fewer steps you have involved in processing a sample,

21 the less variability you're going to get.

22 COMMISSIONER NORD: Okay. Thank you.

¶ Page 123

1 CHAIRMAN TENENBAUM: Okay. Commissioner

2 Northup?

3 COMMISSIONER NORTHUP: Yes. I have a question

4 for Mr. Piorek.

5 I'm interested in expanding on -- I sort of
6 put all my questions together, they're all on one

7 subject.

8 First of all, what are the properties for

9 which lead provides some function in metals, that are

10 important to their functioning well?

11 And just because you can eliminate the lead, I

12 guess the same question is: What would you expect to

13 happen? What sort of loss of function would you

14 expect?

15 Currently, you know, for these traits of lead,

16 are there currently metals that you can replace in

17 these metals that will give you that same function?

18 Have they been tested for toxicity?

19 And in metals, is the removal of lead a

20 problem? In other words, if it's naturally occurring

21 above the level, is the removal of it a problem?

22 MR. PIOREK: It's a very interesting question.

¶ Page 124

1 And perhaps I'm not the best person to answer. But

2 I'll do my best.

3 COMMISSIONER NORTHUP: Okay.

4 MR. PIOREK: The lead, as mentioned earlier,

5 is used as a lubricant, a lubricant when you have two

6 metals rubbing on each other.

7 And commonly used brass bearing, which we can

8 call slide bearing -- not ball bearing -- but slide

9 one, when two surfaces of metal rub against each other,

10 that's when lead particles -- because lead actually in

11 copper doesn't mix well;

12 It is a very normal phenomenon that when you

13 rub brass alloy -- let's say it was something like

14 cloth or sandpaper, and then try to analyze it, you

15 will have very false results;

16 Because lead particles, lead nodules simply

17 will be smeared all over the surface of that alloy at

18 that point.

19 So that tells you what the function doesn't

20 perform. And usually it's on the order of a few

21 percent, sometimes it goes up to five, ten percent

22 even.

¶ Page 125

1 But these are specifics, which I am not

2 really, you know, prepared to answer.

3 In terms of substitution, if we're talking

4 about dysfunctionality aspect of lubrication, then

5 other metals that could be added are unfortunately also
6 no good.

7 Antimony, we don't want antimony there. And

8 so I don't know whether there is an effort going on in

9 that -- to tell the truth.

10 What I would expect, the problem is that when

11 you need to change technology, you need to change the

12 material. It's a chain effect, it's a domino effect,

13 which is very, very widespread.

14 I can only take your attention to that problem

15 of lead-free solder. You've probably heard about

16 so-called "whiskers phenomenon."

17 When you have clean tin, no additives to alloy

18 to the tin metal, when it crystallizes, on the printed

19 circuit board, what happens is due to tensions within

20 the material, the crystals form in the material;

21 Or the tin is crystal material in the first

22 place. And then due to surface tensions, somehow the

¶ Page 126

1 crystals grow upward from the surface of an alloy.

2 And when you look under the microscope, you

3 see like thin, very tiny -- micron,

4 2-micron-in-diameter whiskers.

5 Well, it's maybe a nice picture, but not when

6 you have to use it in a pacemaker, when you have a

7 printed circuit board in the pacemaker, it is there,

8 and it's a very tiny circuit.

9 So components are very close to each other,

10 and whiskers like that can eventually in time develop a

11 short, and render the whole device nonfunctional.

12 We had cases of fighter jets going down

13 because of that.

14 So replacement may be there, but we know

15 nothing about its effect, until after some time lapses

16 and we can evaluate what happened.

17 So these were problems which happened when

18 lead-free solders were mandated. And I don't think

19 that, you know, replacing lead in brass, or eliminating

20 it, would have that kind of consequences.

21 But the conclusion is that we don't know, and

22 it will take time to test.

¶ Page 127

1 The only reason that lead solders were used

2 because we had almost 100 years of experience with it,

3 and we know then, for anyway we look at them, we know

4 the in's and out's of this technology.

5 When lead was taken out of solder, and it was
6 just tin and a little bit of copper and silver, then

7 for example, the melting temperature is higher.

8 So all production lines have to be changed,

9 and that's our consequences.

10 COMMISSIONER NORD: Well, I appreciate that.

11 MR. PIOREK: Yeah.

12 COMMISSIONER NORD: Of course, I'm interested

13 in children's products.

14 MR. PIOREK: Yes.

15 COMMISSIONER NORD: Like you can have

16 lead-free zippers. Would you expect them to be sticky,

17 you know?

18 MR. PIOREK: No, not at all. I wouldn't. And

19 in this case, I don't see the reason for lead to be

20 there at all.

21 COMMISSIONER NORD: Okay.

22 MR. PIOREK: Because it's not critical. It is

¶ Page 128

1 not something that, you know, functionality a hundred

2 percent depends on.

3 So I wouldn't say it. It's just the question

4 of whether material is properly selected for this kind

5 of application. In terms of, you know, a zipper, you

6 want no lead and lead alloy, that's all right.

7 CHAIRMAN TENENBAUM: We're almost out of time

8 for this panel. And I want Commissioner Adler to be

9 able to ask questions as well.

10 So Commissioner Adler?

11 COMMISSIONER ADLER: Very briefly.

12 First of all, I met Satbir at the toy fair

13 yesterday, and I had a delightful conversation with

14 him. And I want to thank you for being so gracious and

15 so helpful.

16 If I'm listening to you correctly, I'm asking

17 this across the group there, it sounds to me like most

18 of you are saying that we can do it predictably we can

19 do it reproducibly, we can do it accurately.

20 So I guess the next question for me is: Can

21 you do it cheaply? And what are your costs, structure,

22 and is there any marginal cost associated with moving

¶ Page 129

1 from testing at 300 parts per million to 100 parts per

2 million?

3 In other words, if I came to you and said,

4 "You've been testing at 300. Are you going to charge

5 me more now that you're testing to 100? Are you going
6 to charge me more?"

7 And I throw that question open to everybody.

8 And then I do have one additional question for Mr.

9 Bush.

10 MR. PIOREK: My short answer is no. There's

11 no difference at all.

12 MR. GANDHI: Yeah. There is no cost

13 differential between testing against a

14 300-parts-per- million limit versus

15 100-parts-per-million limit.

16 To the question of overall cost, you know, in

17 a laboratory, we are testing with a variety of

18 techniques, including that XRF as well as the wet

19 chemistry technique.

20 And you know, I mean, Satbir mentioned the

21 example of the uncoated metal. But when you're

22 de-constructing a product we don't know if it's an

¶ Page 130

1 uncoated or not.

2 So the reliability of that low number is good,

3 but I don't know whether it's actually an uncoated

4 material.

5 Visually you cannot tell.

6 And so overall, the cost of the, you know,

7 testing, you know, there are other ways to limit the

8 cost.

9 And you know, to the numbers that Don Mays

10 spoke about earlier, those are all list price costs, I

11 should also point out.

12 You know, there are significant savings that

13 are passed on to the customer when they are testing

14 multiple composite samples, as well as when they have,

15 you know, volume-based discounts.

16 You know, they are labs that are able to

17 provide by a factor of two and three on the numbers

18 that Don Mays mentioned, the cost savings.

19 Thank you.

20 MR. NAYAR: I just have two points, again

21 specific just to the new method.

22 Number one, that technique does measure and

¶ Page 131

1 quantify the paint separately from the coating. So if

2 you do have a coated sample, both the paint has to

3 comply with the 90-PPM limit, and the substrate with

4 whenever the limit is at that time.

5 So by being able to measure both of them
6 together, you're by definition reducing costs.

7 Also because the technique is non-destructive,

8 the amount of time spent on preparing a sample, as well

9 as if it's a sample of value, can be, you know,

10 returned.

11 So that would lower the cost, as well.

12 COMMISSIONER ADLER: And I guess I didn't hear

13 from any of you. We did hear the price that Don Mays

14 quoted. Does that sound like prices that you have

15 heard quoted, or that you would quote?

16 I'm getting heads bobbing "yes." Is that

17 correct?

18 MR. BUSH: Well, IFIA and ACIL are trade

19 associations. So as such, we're barred from discussing

20 prices under the US anti-trust laws --

21 COMMISSIONER ADLER: Wouldn't want to get you

22 prosecuted by the Justice Department.

¶ Page 132

1 MR. BUSH: Yeah. But notwithstanding that, I

2 would say that the answer to the question would be no.

3 COMMISSIONER ADLER: And Mr. Bush, I may not

4 have heard you correctly -- but correct me if I'm

5 wrong -- did I hear you say that it was your impression

6 that the majority of retailers are actually requiring

7 their suppliers to test to 100 parts per million?

8 Or if I didn't hear that, what part did I hear

9 from you?

10 MR. BUSH: Yeah. I would have to refer back

11 to my testimony to give you an answer to that.

12 But what happens largely is that the large

13 retailers or those that required third-party testing

14 would -- well, before I get myself in trouble, which

15 I'm about to do, I would need to refresh my testimony.

16 I will give an answer to you in writing, if

17 that's okay.

18 MR. DODD: Commissioner, I can offer some

19 thoughts on that.

20 COMMISSIONER ADLER: No, no. First of all,

21 I'm not trying to pin you down; I'm just trying to

22 get --

¶ Page 133

1 MR. DODD: No, no, I understand.

2 COMMISSIONER ADLER: Yeah. Okay.

3 MR. DODD: I do know a lot of retailers are

4 going to 40 PPM, in fact, because of the Illinois

5 statute.
6 COMMISSIONER ADLER: Right.

7 MR. DODD: Others are at 100 PPM and others on

8 substrate obviously adhere to the 300 PPM. It's across

9 the board.

10 I would say the trend is heading actually

11 because of the Illinois statute towards 40. I've seen

12 a lot of that.

13 But it's a variety.

14 COMMISSIONER ADLER: And do any of you have

15 just even an impression about what the percentage of

16 the marketplace is, that is moving in that direction,

17 or there now?

18 MR. DODD: (Off mic.)

19 COMMISSIONER ADLER: I did want to comment

20 about something that Mr. Gandhi said. I was so

21 disappointed, by the way, to see that SGS didn't stand

22 for Sanjeev Gandhi, because then I would have been

¶ Page 134

1 talking to the owner.

2 But you know, one of the big problems for us,

3 at least, or at least for me, is that you're saying we

4 give bulk discounts.

5 We've also heard from these folks in the

6 homemade toy lines, who say "We don't get the advantage

7 of bulk discounts."

8 And so that makes it even more challenging for

9 them to be able to meet these standards, whether it's

10 300 parts per million or 100 parts per million.

11 Have any of you thought through the problem

12 associated with the costs for the small manufacturers?

13 And is there any relief either within your institutions

14 or across the land, that you know of?

15 MR. GANDHI: I personally haven't had any

16 interaction with any small, little company. I'll be

17 happy to talk to them and see what we can do.

18 CHAIRMAN TENENBAUM: This concludes our

19 hearing for this morning.

20 We will be back at 1:30. And so there are two

21 canteens --

22 (End of Panel No. 2.)

¶ Page 135

1 CHAIRMAN TENENBAUM: Okay. We're all here

2 again, and we thank you for joining us for our third

3 panel, as we discuss the CPSIA's requirement that we go

4 to 100 parts per million lead in children's product,

5 unless it is not technologically feasible.
6 So Rick Woldenberg, would you begin, and

7 introduce yourself?

8 MR. WOLDENBERG: Hi. Thank you for having me

9 here today. I'm Rick Woldenberg from Learning

10 Resources. We're at Vernon Hills, Illinois.

11 Manufacturer of educational materials and educational

12 toys.

13 This is the fifth time that I've appeared

14 before the Commission in a hearing, and I appeared here

15 today at the request of the CPSC.

16 In considering the question before the

17 Commission today, I have to say, since economics have

18 been put to that side, I believe that you you've posed

19 a question with no answer, or with an obvious but

20 unwelcome answer.

21 The standard of 100 parts per million looks

22 good on paper, but really does not work in the real

¶ Page 136

1 world.

2 You know, I think it's appropriate to think

3 back to what we heard this morning. We heard the

4 consumer union come out against brass bands. We heard

5 the Academy of American Pediatricians express concern

6 that two-year-olds would be licking their brother's

7 bicycle.

8 We heard testing companies say that they're

9 ready and willing to test our products. And we even

10 heard one roll out a new product.

11 Some might say that we're facing a conspiracy

12 of neurotics and profiteers. Unfortunately, for us in

13 the business community, complying with this new

14 provision is going to involve a tremendous amount of

15 risk, financial risk that we will have a great deal of

16 difficulty managing.

17 I'd like to say that there is another factor

18 at play here. When Quin Dodd mentioned that many

19 retailers are now rolling out a 40-parts-per-million

20 standard to meet the Illinois lead labeling law, he

21 really reminds me of the public fear factor;

22 Because the 100-parts-per-million standard, if

¶ Page 137

1 endorsed by this Commission, will be taken by the

2 general public as an endorsement by the federal

3 government that 100 parts per million constitutes the

4 threshold for safety.

5 And although it's an arbitrary standard and
6 two years ago it was 600 parts per million, three years

7 ago it was nothing, and last year it was 300 parts per

8 million, and it's currently 300 parts per million, we

9 would have the U.S. government make a public statement

10 essentially that you cannot trust items over 100 parts

11 per million.

12 And that will naturally be interpreted as a

13 house standard.

14 This has already been taken on board in the

15 marketplace. I think that if you recall the U.S. PIRG

16 Trouble in Toyland in the November 2010 Report, you'll

17 see that they have something "examples of toys in

18 children's products containing potentially toxic lead."

19 They managed to find two.

20 The first one was the Princess Expressions

21 Tiara, sold at K-Mart, which tested out at 87 parts per

22 million lead. And I quote. It says:

¶ Page 138

1 "While this does not violate CPSIA standard for

2 lead in surface coating, scientists have not identified

3 a safe level of lead exposure for children."

4 In other words, anything with lead, even below

5 the standard, can't be trusted. And they feel the

6 right to call that out to the public.

7 They cited a second item for 97 parts per

8 million lead.

9 We're going to be facing that. And

10 unfortunately, I also believe that the folks that are

11 advocating for the 100 parts per million standard are

12 reasoning from the wrong data.

13 When you look at Dana Best's testimony in

14 2007, to the Bobby Rush committee, she stated that "In

15 considering existing guidelines, it's critical to bear

16 in mind that many were set, but more research

17 demonstrated the harmful effects of lead at low

18 levels."

19 And then she recited several examples. She

20 cited paint, which is soluble lead; jewelry, which is

21 soluble lead; she cited water, which is soluble lead;

22 dust, which is soluble lead; candies, which is soluble

¶ Page 139

1 lead; food, which is soluble lead; cosmetics, which is

2 soluble lead; airborne lead, which is soluble lead;

3 And then calls for the banning of all lead,

4 including inaccessible bound-in, lead-in-substrate

5 lead. It's just not the same thing.
6 They are also using scare tactics, where they

7 use the strategy of influence called "losses loom

8 larger than gains," where she illustrates that a

9 million children might be injured by this, but cannot

10 cite a single example of a child that's been injured by

11 lead in substrate.

12 The absence of known victims is a critical

13 problem with the argument in favor of lead and a ban on

14 lead in substrate down to 100 parts per million.

15 Because there was no causal link between the

16 products that I make and actual known injuries, and the

17 proponents of this standard have yet to produce

18 evidence that my products, or products made by people

19 like me, have actually injured children.

20 They just assert that they're out there.

21 And the problem with that is that if you

22 cannot measure the harm that's been caused because they

¶ Page 140

1 cannot identify injured victims, you likewise cannot

2 identify the benefit that's been gained by changing the

3 standard.

4 Regardless of whether it's cheap or expensive,

5 you can't identify the benefit.

6 But I can tell you what it's going to cost me.

7 And that's a lot of money.

8 Now the losses in going from 300 parts per

9 million to 100 parts per million are a little different

10 than what we've covered previously this morning,

11 because it's really not an incremental cost in testing.

12 The cost is in waste. The cost is in managing

13 the process. The cost is in shipping delays, rejected

14 lots, penalties, and the like.

15 It exposes people, particularly those who make

16 to order, tremendous financial risk.

17 I'd like to argue too, that in fact

18 100-parts-per-million standard is really a

19 zero-parts-per-million standard.

20 When lead in paint was regulated at 600 parts

21 per million, that standard was intended to induce

22 corporate behavior. If you had lead in paint, your

¶ Page 141

1 numbers came up much above 600 parts per million.

2 Lead was an ingredient, you poured it in to

3 leaded paint, and so your numbers were much above 600.

4 If you had non-leaded paint, it was much below 600.

5 Your tests never came in at 600.
6 So if you were good and you just never bought

7 leaded paint, you never blew it. It was easy.

8 At 100 parts per million, notwithstanding what

9 we've been told today, in my experience, we're down

10 near the measurable limits.

11 I can give you data. We had 2,701 passing

12 test reports in a two-year period from '08 to '10, and

13 1.7 percent of our products came in the range of 100 to

14 300 parts per million.

15 The problem is, I can't tell you which ones

16 in advance. So I have a tightly-controlled supply

17 chain. I know what I'm doing. I have the record to

18 back it up.

19 But I can't tell you in advance. I have to

20 check them all to find out which ones come in that

21 range. Every single one in that 1.7 will be a reject,

22 and I'll have to pay for those lots.

¶ Page 142

1 Because your law says that anything over 100

2 will be not legal to sell and not legal to export. So

3 that means it's just garbage. I'll have to pay for

4 that.

5 Now if I go and I produce something for my own

6 inventory or for Walmart or for whenever, and it comes

7 in at 101, it's no good. If it comes in at 100, I can

8 sell it.

9 So 100 is safe, 101 is not. What's the

10 difference? One part per million. The body does not

11 know which is that one parts per million, but the extra

12 1 part per million makes the whole lot garbage.

13 That's a standard of zero. If you have more

14 than zero parts per million, it's no good, because

15 you've arbitrarily set the deadline, the number around

16 100.

17 We have taken a piece of string, cut it into

18 ten pieces. I submitted this with my comment letter on

19 100 parts per million. You have a copy of this test.

20 We counted ten parts, we tested it ten times.

21 The numbers came in scattered all over the place. Same

22 piece of string from 239 to 275.

¶ Page 143

1 We've taken tape measures from the same lot,

2 tested three of them. They've come in between 79 and

3 97.

4 We've taken the same piece of substrate out of

5 the same lot, same toy, same identical material, tested
6 it three times. It's ranged from 23 to 139: 23, 88,

7 139.

8 If we tested the right one, we'd pass. If we

9 tested the wrong one, we'd fail.

10 This is a problem for me, because I can't

11 control it. The world is not perfect, it's not utterly

12 and totally homogeneous. Every test is not exactly the

13 same;

14 And every time something goes over 100, I'm

15 going to have to pay.

16 My costs are going to go through the roof.

17 And that's not really in doubt.

18 We've been told by our factories to expect a

19 ten to 20 percent cost increase. And quite frankly, I

20 really can't imagine the world where we have to deal

21 with this, so I really can't predict where it's going

22 to all shake out.

¶ Page 144

1 I do accept that this is not a static world,

2 and people will evolve and shift. But we are so low at

3 those standards, that this randomness of cost incursion

4 by me is very unlikely to abate.

5 And because it can't be controlled, it could

6 be severe.

7 Please remember that sometimes individual

8 components will fail, as well. So if you make up a lot

9 of backpacks, and you test a zipper after it's made,

10 and the zipper fails, what are you supposed to do?

11 You could test the zippers until the cows come

12 home beforehand; but after you sew them in, if you test

13 the final product and the zipper fails, what am I

14 supposed to do? I have a failing test report.

15 I can't take all the zippers out. I tested

16 the zippers before, and they were fine. I tested them

17 after they're in, they're bad. Throw out all the

18 backpacks.

19 Should I submit the bill to the CPSC? I mean,

20 let's be realistic here. It has no pattern.

21 We're going to have sharp increases in our

22 component surveillance costs. We expect to lose

¶ Page 145

1 vendors, and we expect to lose products.

2 Companies are going to go away from this.

3 It's worth nothing, since part of what's been discussed

4 here is the projected movement of the market, that in

5 previous hearings, there has been specification that a
6 market would open up of component manufacturers that

7 would test to meet your standards.

8 That market does not exist. We're three years

9 in.

10 So what I'd like to know is: When are they

11 coming? Three years in, that component manufacturers

12 have not been testing for standards, partly because I

13 don't think they want to be subject to your

14 jurisdiction.

15 So when we project that the market is going to

16 shift, and everyone's going to change all these

17 materials to meet the 100 parts per million, I suggest

18 to you that we have data that suggests that that may

19 not happen.

20 But the certainty is that I have to meet the

21 standards. And I just think that that's wholly

22 unrealistic.

¶ Page 146

1 The 15-month rule, which hangs out there over

2 our head, has some very specific language on what the

3 consequences will be to me of a failed test report.

4 The CPSC at least, as of today, seems to have

5 a great interest in what I do, when I get a failed test

6 report, because I presume that CPSC thinks I'm going to

7 test until I get a passing test report, and then call

8 it a day.

9 So the consequences of a single failed test

10 report, many times we don't even control the test

11 reports, because third parties can do them. Or even

12 our customers can do them.

13 The consequence of a failing test report under

14 the regime that's kind of hanging out there is

15 dramatic. I can't pay those bills; it's not just the

16 bills to the testing company; it's the bills to my

17 factories, it's the bills to the lawyers; because I'm

18 going to have to file my 15(b) reports and go through

19 all kind of processes with you;

20 It's the bills to my customers, who list my

21 products in their catalog, or who promise my products

22 to their customers.

¶ Page 147

1 I can't handle all this unpredictability.

2 It's just going to all come back on me.

3 So it's an extremely tight standard, that

4 leaves me no room to manage the process.

5 And I'd also like to tell you that I think one
6 of the very unfortunate aspects of this is that we're

7 not going to be able to use recycled materials.

8 We sell some products made of recycled

9 materials, and we think we're doing some good by doing

10 that. But quite frankly, you'd be lunatic to sell

11 recycled materials after this.

12 This is a tacit ban on recycled materials,

13 because your standard is too tight. And there's no way

14 I can really manage to it.

15 The relationship between these financial risks

16 and the lack of causal link between my products and

17 actual documented, real, live, with photographs, injuries,

18 calls into question: Why would we impose all of these

19 risks and costs on the manufacturing community for no

20 particular purpose?

21 I can and I do accept -- and it's not worth

22 arguing about -- that lead is dangerous. But lead is

¶ Page 148

1 not dangerous in every manifestation. It's not uranium

2 and it's not germs.

3 If I have lead in my pocket, it's not going to

4 get into your blood stream. So we know that lead, and

5 not in every case, is a danger to someone else.

6 So we need to think about: What are our

7 priorities? The Consumers Union highlighted in several

8 examples vinyl. If the CPSC decides that vinyl is a

9 problem, that's fine. But that doesn't mean that we

10 have to regulate metal grommets.

11 If vinyl is the problem, let's regulate vinyl.

12 If jewelry is a problem, let's regulate jewelry. But

13 just because you conclude that jewelry is a problem,

14 that does not mean that everything that a child ever

15 has is a problem.

16 And I'd like to say one final thing. The

17 absence of a causal link between our products and known

18 injuries is partly because the sources of lead in a

19 child's life is variable and uncontrolled.

20 They breathe it, they eat it, they drink it.

21 They get it when they touch their car, because I'm sure

22 you're aware all of our cars are coated, they are a

¶ Page 149

1 moving popsicle of leaded paint.

2 So they get lead from lots of different

3 places. They touch the car, they put it in their

4 mouth.

5 But the focus of this legislation is to blame
6 the things that we make. And I think I, as an American

7 company, deserve the right to have it proven that my

8 products are the cause of these asserted conjectural

9 injuries.

10 I'm hoping that the Commission will strongly

11 consider the impact on American manufacturers of

12 tightening this standard, and will, in fact, give us

13 relief, which is what we need.

14 CHAIRMAN TENENBAUM: Thank you,

15 Mr. Woldenberg.

16 Mr. Locker?

17 MR. LOCKER: Yes. Thank you, Madame Chairman.

18 I'm here in a capacity today of representing a

19 number of clients and also my own particular view.

20 We do represent the toy Industry Association,

21 the Juvenile Product Manufacturers Association, and

22 Halloween Industry Association, the Craft and Hobby

¶ Page 150

1 Association, and the Coalition for Safe and Affordable

2 Children's Wear.

3 In part, I'm here to give you a bit of a

4 report card on how we're doing, and to address the

5 specific question that you have to struggle with,

6 because it's been mandated by Congress, in dealing with

7 the issue of the drop-down in lead from 300 to 100

8 parts per million.

9 First of all, as we heard today -- and it even

10 has been echoed throughout the panels -- we're not

11 going to rehash the health issue. To us, it's very

12 clear. The issue is: Acute and chronic exposure, as

13 Dr. Best talked about; but the issue is also one of

14 accessibility, migration, solubility.

15 And it's true that whether you're talking

16 about the lead popsicle that Mr. Woldenberg talked

17 about before, or many products in bicycles that are

18 children's products, or the brass instruments, you're

19 really not likely to have a human health risk in

20 exposure.

21 But that's a problem I think, as you've set

22 forth, that as much as you'd like to solve, that

¶ Page 151

1 Congress has to solve.

2 But here we're dealing with a section that

3 perhaps we can have some resolution. And I'm mindful

4 of the fact that when Congress mandated this further

5 drop-down, that it did allow some flexibility.
6 Now I agree it's not much flexibility. And I

7 certainly agree that requiring that exceptions to be

8 based only after the Commission has a hearing and with

9 qualifiers that it be technically feasible, perhaps

10 many of you feel that you're constrained by that as

11 well.

12 But it does present an opportunity to assess

13 where we are, where we're going, and perhaps where we

14 can go. And perhaps what we can do.

15 Particularly in the context of the issue of

16 how we're going to consider and define what is

17 technologically feasible.

18 Now the funny thing about that term is: It

19 means different things to different people. But within

20 the scientific community, I think you'll have a general

21 consensus, if we're using that as a standard, that the

22 issue is defining a comprehensive number of technical

¶ Page 152

1 options that are feasible within known demand and

2 demanded resources and requirements.

3 If Congress meant to say that you could only

4 do it if it was technically possible, they would have.

5 I think by using the word, "feasible," they allow you

6 some flexibility.

7 Because what feasible means to us, at least in

8 industry as a practical sense of the word, is: Capable

9 of being done and dealt with successfully.

10 It doesn't mean that it's, you know,

11 impossible, or possible, you know, possible. What

12 we're looking at is: Is it achievable? Is it

13 attainable?

14 Is it doable? Is it practicable? Can you

15 realize it?

16 So in that term, we have to look at it and

17 take a look at how this issue affects the products that

18 a whole array of industries make.

19 Now I'm very mindful of the fact that the

20 children's interpretative rule that came out is

21 designed to perhaps narrow the impact of the broad

22 range and array of children's products, and sort of

¶ Page 153

1 ameliorate the impact on products they never thought

2 would be subject to the rule, and never historically

3 have had a problem.

4 I'm mindful of the fact that your exclusionary

5 rule -- though I wish it went further in terms of more
6 materials -- I'm very mindful of the fact that that

7 rule does provide some relief.

8 I'm mindful of the fact you're a bit

9 hand-cuffed by your Congressional statute.

10 And we're hoping that Congress, as I'm sure

11 each and every one of you hopes, would allow this

12 agency the discretion, the ability, to base their

13 policies the way you traditionally have, on human

14 health risk and exposure, what Dr. Best called the

15 acute and chronic hazards, not merely because lead is

16 present.

17 And in that context, when we are looking at

18 this across our industry, about what is doable, what is

19 achievable, what is feasible, this is sort of what we

20 found out.

21 And you've heard a bit of it this afternoon

22 from the laboratories and the technical groups.

¶ Page 154

1 We've determined for the most part, when we're

2 dealing with the homogeneous materials, like plastic,

3 and paint and pigments, that we have a good successful

4 story to tell you.

5 We certainly have achieved it in terms of

6 moving down to 300 parts per million. We think it is

7 achievable to move to 100 parts per million.

8 But this has not been done at a light cost.

9 It has been done at an extreme cost to industry, to

10 competitiveness, in effect the economies of many, many

11 businesses and companies.

12 But it is technologically feasible.

13 Where it is not -- and I think you heard an

14 inkling of it -- when the representatives from SGS and

15 Thermo Fisher and XOS talked about this concept of, you

16 know:

17 What is feasible in terms of the capabilities

18 of doing this on non-homogeneous materials? On

19 heterogeneous materials? Particularly on metal alloys,

20 there has been a problem.

21 And it's not a question just of, you know, a

22 percent that you only found, you know, four or five

¶ Page 155

1 percent. Because that's across, you know, the 90,000

2 data subsets.

3 But we've decided to dive further into that,

4 and look at particular products, where this was a

5 problem.
6 So we collected components and materials and

7 we did send it out also for testing to see where it

8 was.

9 Originally, we thought we were going to have a

10 problem, similar to what you experienced -- and

11 Congress too -- in dealing with electronics.

12 We thought that we'd find some component

13 materials could not even reach 600 parts per million.

14 And so we were pleasantly surprised that many

15 of the materials that we use in a variety of these

16 industries, including, you know, apparel and craft and

17 hobby and toys, and juvenile products, were capable of

18 meeting the current 300-parts-per-million level.

19 But where we began to see problems, was in

20 certain materials, particularly metallic,

21 non-homogeneous alloys, or heterogeneous alloys, that

22 were below the 300 parts per million.

¶ Page 156

1 And it wasn't because we weren't trying. It's

2 because just as with the electronics components in our

3 products, we rely on other industries to provide and

4 supply that to us.

5 When we're talking about a lot of these metal

6 parts, the nuts and bolts, if you will, of all

7 industries literally, the fasteners and nuts and bolts

8 and metallic materials, we have to rely upon the

9 general marketplace.

10 And the marketplace just isn't there yet.

11 They're not making that 100 parts per million or below

12 material for the screws that keep the battery

13 compartments, you know, easily on toys.

14 And that's why you see a lot of these things

15 recessed, or we try to make them inaccessible.

16 But because your definition of accessibility

17 didn't cover, you know, ingestability or mouthability,

18 but went so broad to include touchability regardless of

19 whether the lead was truly accessible from that part,

20 because of that, we're having problems.

21 So we find ourselves in the conundrum of

22 having many electronic products, where those same parts

¶ Page 157

1 are excluded, because they are ROHS-compliant, pursuant

2 to your rule; but a non-electronic product that's

3 identical to it, it wouldn't be.

4 And so there seems to be sort of you know, a

5 logic to that. And it's not because of lack of trying,
6 because we did try.

7 The reason I think we found out about this was

8 because it's really -- and I wish that there was on one

9 of these panels a metallurgist, and I wish we had, you

10 know, representatives from -- because there is an

11 association for everything, the fastener and parts

12 industry -- because I think you would find that that

13 issue does come into play.

14 I think your second panel did touch upon that.

15 You know, that is intentionally added, whether it's to

16 keep the fighter planes going or the pacemaker

17 functioning, it is added intentionally in some types of

18 metallurgic processes.

19 And it is bound in a different way in certain

20 materials.

21 And unfortunately, we need those materials.

22 We need the materials to keep toys bound together, so

¶ Page 158

1 they don't break upon and reveal small parts.

2 And we need those fasteners and we need the

3 latching mechanisms on our child restraint seats, so in

4 a crash situation, we need to make sure they're

5 corrosion resistant, to meet NHTSA requirements.

6 We need to make sure they're crash-worthy and

7 strong.

8 So we need these materials, and we can't

9 create them from whole cloth, we have to purchase them

10 in the marketplace.

11 And unfortunately in our assessment, the

12 marketplace is not there yet on those components. So

13 we have a good story to tell you about plastics, and in

14 many ways a pretty good story to tell you, because we

15 can get there on many glass and ceramics.

16 But on certain, on metal alloys, and

17 particularly in regards to commonly used metal

18 components that we have to buy from other industries,

19 and this affects all these different industries, it's

20 more problematic.

21 And I'd be happy to answer questions. So I'm

22 mindful of the time and I would rather hear from you

¶ Page 159

1 than you hear from me.

2 Thank you.

3 CHAIRMAN TENENBAUM: Thank you, Mr. Locker.

4 Ms. Chapman?

5 MS. CHAPMAN: Hi. Thank you for allowing me
6 to present today.

7 Maybe I should start off by saying that I am a

8 neurotic mother of two boys, and a recent entrepreneur.

9 Neurotic I added to my presentation, in case that

10 wasn't in your notes.

11 I have been working on a toy product for two

12 years. And just recently launched by toy for sales on

13 December 1, 2010.

14 The toy is a set of keys for babies six months

15 and up, that are made entirely of food-grade stainless

16 steel. So stainless 304.

17 I want to give you a little background on my

18 motivation to create this toy prior to talking through

19 the logistics of testing.

20 Over the past six years, really, since the

21 birth of my first son, I've become more and more aware,

22 or neurotic, about the various toxins in the

¶ Page 160

1 environment that I truly believe are leading to

2 increased rates of illness in our population.

3 So whether that be developmental delays,

4 autism, or cancer.

5 My evolution started with food, and then moved

6 to cleaning supplies, and then skin and hair care

7 products, and eventually toys and consumer goods.

8 I'm not a scientist, so I'm not here to

9 present the facts behind how the various chemicals

10 impact us.

11 However, I'm sure many of you have heard, as

12 we have today, the numerous studies talking about lead

13 and then also most recently about BPA.

14 I had become an incredibly skeptical consumer,

15 because of these studies. And even if I don't have a

16 study that proves my suspicions, I'm still skeptical.

17 What I do know is that I have a friend, who

18 just told me last week that she learned of six people

19 in one week -- close relations, like only, you know,

20 one person in between -- who were diagnosed with cancer

21 in a week.

22 And this was newborn-to-mid-30's, which is an

¶ Page 161

1 incredibly young population.

2 I feel like I hear stories like this all too

3 often. And I think that we should all be alarmed

4 enough to insist on changes regarding toxins in our

5 environment.
6 The reality is that most kids put toys in

7 their mouths. I was not as sensitive to this with my

8 first son, who absolutely loves Thomas the Train, but

9 fortunately did not put Thomas the Train in his mouth.

10 When many of the Thomas products were recalled

11 because of lead in the paint, I sent all the affected

12 ones back to the company.

13 But I did not worry too much, from a personal

14 standpoint, because my eldest didn't put toys in his

15 mouth.

16 My second son has been a totally different

17 story. He literally puts everything in his mouth. So

18 yes, he would unfortunately suck on a bike. And he's

19 almost three, and still puts things like that in his

20 mouth.

21 So as a consumer, I find myself seeking toys

22 that I know have greater restrictions on them. So, for

¶ Page 162

1 instance, buying from European companies that are held

2 to slightly higher standards by their government and

3 the regulations that they have to meet there.

4 But while I'm particular about what I purchase

5 for my kids, they also have really generous

6 grandparents, whom I don't want to knock, because they

7 are very generous.

8 But they don't specifically seek out European

9 regulations. In fact, they're more often purchasing

10 items from discount stores, items that often come from

11 China, and that honestly make me cringe as a parent,

12 when I see my kids put them in their mouths.

13 So when the idea struck me that the market

14 needed a better toy key alternative, I was committed to

15 designing something that was absolutely safe for all

16 kids.

17 Because in the end, it's not just a personal

18 thing. It's not just my child that matters. It's also

19 not just about making money. It's about providing a

20 product that hopefully is a winning business model, but

21 that ultimately is safe for the individual kids

22 enjoying it.

¶ Page 163

1 It's a product that does not lead a parent to

2 cringe when their child inevitably puts it in his

3 mouth.

4 So how did I get from that idea for a toy and

5 commitment to safety, to actually launching my product?
6 I was lucky that I knew that I could make the product

7 out of a safe material, something that we eat off of

8 and cook with every day: Food-grade stainless steel.

9 Honestly, the material itself was the

10 motivating factor behind the idea. When it came to the

11 logistics of getting the toy to market, beyond the

12 obvious cost of manufacturing, the other costs I had to

13 consider were: Testing the product for compliance, and

14 liability insurance.

15 I never considered not testing, for that would

16 have been a risk to my company for law suits, as well

17 as a risk for recalls. And then back to individual

18 children, it also would meant risking their safety.

19 I also never considered not doing the lead

20 testing, because I wanted to be able to assure parents

21 that I was offering a completely safe product.

22 From a consumer perspective, I know that I

¶ Page 164

1 want the assurances. So again, back to my desire for

2 stricter standards.

3 When it came down to the expense of it, the

4 liability insurance was what nearly led me to give up

5 on my dream of producing the keys. It was not the

6 testing.

7 Liability insurance for someone like me was

8 over $8,000. Testing, including additional testing for

9 cadmium, lead, and nickel, all of which were, by the

10 way, not required because it was stainless 304 -- but I

11 did anyway, because I wanted to be able to assure

12 parents -- all of that was still less than $1,000,

13 including the physical and mechanical.

14 So realistically, had the test results come

15 back and were shown to have lead in the toy, I would

16 have been totally devastated.

17 However, I made it clear in my purchase order

18 to the manufacturer that I wanted material

19 certifications for the stainless steel, and

20 specifically that it could not contain lead.

21 This was not difficult to request, and it

22 seemed to me that all manufacturers could require

¶ Page 165

1 material certification prior to purchasing the material

2 used for the components for their toys.

3 If Europe is holding companies accountable to

4 safeguard their citizens, by having more stringent

5 restrictions, what makes it so difficult to do here?
6 Back to my story about Thomas the Train, since

7 that's the one that affected my family -- and by the

8 way, this is not to single them out, because we still

9 love Thomas, you know, five years later -- but would

10 that company not have saved money by finding out before

11 manufacturing the product, what was in the paint?

12 Could we not take steps to ensure that

13 components are safe before they're made into the final

14 product?

15 Ultimately, I have to believe that the cost of

16 a recall, both from the practical expense of performing

17 the recall, but also from the detriment to the brand,

18 has to cost more than ensuring components are safe from

19 the beginning.

20 And frankly, if it's question of a company

21 using a manufacturer, who has misled them, a contract

22 stipulating exactly what is expected as far as

¶ Page 166

1 materials should be part of the negotiations from the

2 beginning.

3 If the product does not meet the specified

4 safety expectations, that contract should denote that

5 the manufacturer needs to take the financial risk, so

6 that they are the ones held accountable.

7 Why is it that we cannot offer the citizens of

8 the U.S. the same kind of safety protections as are

9 afforded European citizens?

10 I truly believe that a responsible company is

11 one who is honest about the end result of their product

12 on the individual.

13 So whether that be a direct impact through

14 chemicals in the product, or an indirect impact through

15 deleterious effects on our environment -- for example,

16 water and air quality.

17 In the end what will cost us more as a country

18 is treating illnesses caused by the harmful effects of

19 known toxins like lead, especially in the most

20 vulnerable little bodies that are even more susceptible

21 because of their small size.

22 In the end, don't we all want our loved ones

¶ Page 167

1 to be safe? And isn't everyone someone's loved one?

2 Thank you.

3 CHAIRMAN TENENBAUM: Thank you very much.

4 Now we have three people from the Bicycle

5 Products Supplier Association and ACT:
6 Erika Jones, John Nedeau, and John Bogler.

7 Now which of you will go first? You'll go

8 first, John Nedeau?

9 MR. NEDEAU: Thank you, Chairman,

10 Commissioners.

11 I am John Nedeau. I'm President of the

12 Bicycle Products Supplier Association. We represent an

13 association of suppliers of bicycles, parts,

14 accessories, and services, who serve the specialty and

15 mass market retailers.

16 Our membership includes companies that easily

17 represent over 90 percent of the children's bicycles

18 produced new and sold new in the U.S. annually.

19 We're here today to urge the Commission to

20 make a timely finding that the lead substrate standard

21 of 100 parts per million is not technologically

22 feasible for children's bicycles.

¶ Page 168

1 We've retained John Bogler of ACT Lab,

2 established expert in lead substrate testing, to assist

3 us in presenting evidence to support our position.

4 So thank you for this opportunity. And John

5 will move us along on the presentation.

6 MR. BOGLER: Chairman and Commissioners, thank

7 you for the opportunity.

8 I am basically going to, probably not as

9 eloquently, but repeat what Locker and Woldenberg had

10 to just say.

11 Bicycles, or primarily children's bicycles,

12 are primarily made out of steel, and its metallics.

13 There are plastics and there are vinyls on it. And I

14 will agree with both of you, those aren't really an

15 issue, and it's nothing that I've seen to really

16 discuss.

17 What we're here to discuss about is getting

18 metallic products from 300 to 100 in the test results

19 that we've seen.

20 ACT was started basically in 2008 because of

21 CPSIA. We started a small independent third-party

22 compliant test lab to test bicycles and helmets.

¶ Page 169

1 That's where our expertise is.

2 And I went to China and set up a test lab in

3 China, because that's where most of the product is

4 being made in the U.S. Most of the bicycle companies

5 are importers, private labelers, versus straight
6 manufacturers.

7 Since the CPSIA has taken effect, I've tested

8 approximately 2,500 bicycles. And I have seen a

9 tremendous improvement on the bicycle in the quality of

10 bicycles, from pre-600 parts per million down to the

11 300 parts per million, and in all other aspects of

12 compliance that are required under the standard.

13 What we have now is: How do we go from 300 to

14 100? And can you technologically and feasibly do this,

15 testing associated with manufacturing?

16 Repeating an example of what was talked about

17 by Mr. Woldenberg and I believe also Mr. Locker, is I

18 took the same component and I XRF'd it across the

19 component, as well as ICP'd it, which is the AES ICP,

20 in different areas to show the variability of a part.

21 All of these parts are steel, which is the

22 primary material used in youth's or children's

¶ Page 170

1 bicycles.

2 As you can see, there's a small variation.

3 But when you get down to 100 parts per million, that

4 variation again will take you from being a compliant

5 product to a non-compliant product.

6 And not just the variation from component to

7 component. Within the component itself, you'll see ten

8 to 15 different results. Or 150 if you measure it in

9 150 different locations.

10 The other aspect -- and I'll skip through -- I

11 showed you many different components in this slide

12 show, and I'll kind of breeze by them; but what I want

13 to talk about is there's been discussions about

14 preparation, and the testing process.

15 On a bicycle, metallic-specific, on a

16 multi-speed bicycle, you have approximately 140 to 150

17 "accessible" components on a bicycle.

18 To get those, you have to completely destroy

19 the bicycle, you have to cut it up. You have to

20 disassemble it.

21 The amount of time just to disassemble a bicycle

22 down to the level required by the accessibility alone

¶ Page 171

1 is a day per bicycle.

2 Forget the cost of doing the testing. It's

3 just getting down to those components that you have to

4 cut into parts to get to, because the accessibility

5 probe will actually reach in and touch them.
6 Once you do that, the cost becomes tremendous.

7 And during the 2-1/2 years I've been doing testing for

8 the Bicycle Industry, what I've seen is smaller

9 companies have just chosen not to make children's

10 products any more.

11 And not that the number of products on the

12 market maybe have changed, but the options that

13 children have has dramatically changed.

14 Even within large companies, who might have

15 offered 40 or 50 children models, they are now down to

16 20 or 30.

17 The smaller companies, that had one or two

18 that they were offering for children, have completely

19 left the market.

20 Again, now we're repeating exactly what was

21 just talked about. Bicycles, recycled steel, cost

22 effective, machinability. It works.

¶ Page 172

1 The problem with recycled steel is: It's

2 inconsistent across product.

3 What I've seen as a global, you know, within

4 the Bicycle Industry is: They've made the effort to

5 get it down below 300. What I'm seeing is, to get it

6 down to 100 is basically impossible right now.

7 Not just impossible on the technological

8 manufacturing side of it, but to get the material, when

9 you're talking about a supplier and getting parts for

10 your products.

11 A bicycle that comes to me for third-party

12 testing is a complete bicycle assembled. And it comes

13 for safety testing as well as the chemical testing.

14 Now we have to start cutting up each component.

15 There's 30 to 40 components on a bicycle, and

16 each component has four or five components to it. The

17 bicycle assembler that sends me the bicycle sends it

18 complete, probably didn't produce all the parts that

19 are on the bicycle. You'll have to go to the component

20 manufacturer for that.

21 Then you will have to go to the supplier of

22 the components to the component, to find out what

¶ Page 173

1 material they're using.

2 Then you have to go to the material source,

3 which could be multiple different material sources, at

4 a cost-effective means.

5 By going down to 100 parts per million, I'm
6 afraid, as a test lab, I'm not going to have a product

7 to test. People just won't be able to get it.

8 The number of components, the number of

9 bicycles available will dwindle down to basically

10 nothing for children.

11 Again, the feasibility of material is there.

12 The cost, I think you mentioned, was 20.

13 When I went to Jorgensen Steel, where I went

14 to different steel companies in the United States,

15 right now I can't get a guarantee they'll get 100 parts

16 per million.

17 For a small manufacturer, they'll never be

18 able to get that at the prices that they'll have to

19 pay.

20 The large manufacturers, they have some

21 leverage, they have some options. They'll be able to

22 do it.

¶ Page 174

1 The pricing that I did get was 20 to 25

2 percent more. And that was just going from, you know,

3 600 down to the 300. Going from 300 to 100, you really

4 are getting rid of recycled steel.

5 You're getting rid of a lot of recycled

6 products, and the price is going to up significantly.

7 I tried very diligently. I called Reynolds

8 Aluminum. I called Alcoa, I called Jorgensen. I

9 couldn't get a pricing, to come here and give you a

10 full pricing on what these changes would be.

11 But you can legitimately look at 25 percent

12 increase. And on the children's product, that's

13 selling from somewhere $50 to $200 at 25 percent

14 increase on each raw source material, it's going to be

15 astronomical and take the product to a point where the

16 parents aren't going to want to buy the product.

17 As a test lab, I want to test as much as I

18 can. And I want to make sure the reason I started a

19 third-party CPSC-approved test lab was to make sure

20 that the product that's hitting the market is good and

21 compliant.

22 What I don't want to do is see the Bicycle

¶ Page 175

1 Industry strangled, so I have nothing to test. And I'm

2 very concerned with taking the metallic portion from

3 300 to 100 on children's product right now will reduce

4 that down to a number that there's just not a business

5 there for us.
6 As Mr. Locker said, I'm happy to answer any

7 questions. I have 2-1/2, you know, years now of

8 testing bicycles under the CPSIA. We've already went

9 over pricing differences, sourcing availability and the

10 practicality.

11 Everybody here has already talked about most

12 of these issues. And I'm happy -- I think it was

13 Commissioner Adler, you were asking about how this

14 affects business.

15 And like I said, in 2008, just using rough

16 numbers, there were 40 companies I was testing for it.

17 We were a new company in a new area.

18 Of those 40 companies, ten of them quit

19 selling children's product. They were all of the small

20 manufacturers.

21 Big manufacturers could afford the testing.

22 When you're looking at 141 metallic products

¶ Page 176

1 that have to be tested, that has to be cut out, broken

2 down, and tested, even at $30 -- the lowest price I

3 think somebody said here, which I won't argue in Asia

4 is probably the price -- you're talking about $3,000 to

5 test.

6 A large manufacturer can handle that. A small

7 manufacturer, you know, an entrepreneur or an

8 entrepreneur like me, we can't handle that.

9 And if legislation goes into effect that does

10 that, you'll see more and more small business, small

11 bicycle manufacturers, exiting the market, and it will

12 just get consolidated out into the big ones.

13 John?

14 MR. NEDEAU: Yeah.

15 I would just say, in summary, based on what

16 John's presented and the data that substantiates the

17 infeasibility of stepping down to hard parts to

18 million, that we would strongly urge you to recognize

19 that it's very difficult or impossible for the Bicycle

20 Industry, with children's bicycles to fulfill that

21 standard, and you know, make a timely finding in that

22 regard.

¶ Page 177

1 So thank you for this opportunity.

2 CHAIRMAN TENENBAUM: Thank you all.

3 Erika?

4 MS. JONES: And I'm Erika Jones from Mayer

5 Brown, supporting BPSA today. And I just want to add
6 one clarification point, that I think was brought up

7 early in Mr. Nedeau's comments.

8 The relief that the Bicycle Industry is

9 seeking is for metallic parts. There is no need for

10 vinyl and the Bicycle Industry does not have an issue

11 with vinyls and plastics.

12 So I just want to be sure that that was clear,

13 that the relief we're seeking is for metallic parts.

14 (End of Panel No. 3.)

15 CHAIRMAN TENENBAUM: Thank you.

16 All right. And now we'll go into the

17 question-and-answer period.

18 If you will look, Mr. Bogler, on your axle

19 testing slide? I just want to make sure I understand

20 it. With the test for 1480, the XRF content was 114

21 parts per million lead, and the ICP was 218?

22 MR. BOGLER: That's correct.

¶ Page 178

1 CHAIRMAN TENENBAUM: Okay. Then in other

2 areas, for example, in 1484, you had a higher XRF, 106.

3 And then it was lower with the ICP.

4 If you go on over to your handlebar testing,

5 the third one was 104 XRF, but the ICP was 52. How do

6 you explain these differences in the variability?

7 I know that XRF is screening, but in some you

8 had a higher level with ICP, and some you had a lower.

9 Are you going to find that most of the time?

10 MR. BOGLER: Most of the time what I've found

11 is XRF has a higher result than I find on ICP. As it's

12 kind of been discussed here, it's a good screening

13 tool, and we use it to screen a product.

14 If we see something that's outside of whatever

15 deviation that establish with our customers -- for

16 example, currently the standard's 300 parts per

17 million. I see something at 250 or greater, I suggest

18 that we do an ICP test to verify what is in there.

19 The issue with recycled steel, specifically in

20 these cases -- and I'm not a metallurgist, now I wish I

21 would have brought a metallurgist with me -- but one of

22 the issues is: The chemistry composition of the

¶ Page 179

1 material.

2 We have a lot of iron in these products, and

3 iron and lead on the spectrometry, they're almost the

4 same. So you have to go through a calibration factor

5 to take it in and take it out.
6 ICP and XRF have great systems in place to do

7 that. It's a false-positive, false-negative. It goes

8 both ways sometimes.

9 That specific axle result that you saw that

10 was 218, the first thing I did was the same thing:

11 "Did you guys do the test right? Retest it, do it

12 again." And the same results came up.

13 So I trust the results that we have there,

14 that you will see variabilities. The ICP goes through

15 a different calibration process to offset the iron than

16 the XRF does.

17 XRF tries to also isolate and take if off.

18 We didn't go into much detail about it, but

19 preparation of the components as well, is a major

20 issue.

21 I'm taking this axle out of a hub, so I've had

22 to cut the hub out of a front wheel of a bicycle. Then

¶ Page 180

1 you have to completely disassemble the front hub to get

2 to the axle, so you can test it.

3 When you do that, then you have to de-grease

4 it. How much de-greasing do you do? What type of

5 grease did they use? What kind of lubricants, oils,

6 manufacturing process did they use?

7 And you have to clean it to a point, where

8 then you can use isopropyl alcohol to get the surface

9 prepared.

10 You also have a threaded surface. XRF doesn't

11 really like threaded surfaces. It's trying to see a

12 solid part.

13 If I have a nice, flat surface, that's not

14 polished too much, I can get a better reading. So

15 we'll take a machine and we'll cut the axle down, so

16 that we have a flat surface to XRF.

17 Again, now you're getting into the preparation

18 of the product, and this goes into parts of the

19 accessibility issues that the Bicycle Industry has

20 right now with the probe and different things.

21 So there is a lot of preparation, and I think

22 it was Mr. Gandhi who was talking about every one of

¶ Page 181

1 these steps that we have to do increases the

2 variability.

3 So if you have to disassemble, how you disassemble

4 it; how you de-grease it; how you clean it; the type of

5 isopropyl alcohol you have; then the type of alcohol
6 you have.

7 Then the testing, then the ICP digestion, then

8 the grinding, all of these add variations. And at 100

9 parts per million, I just don't believe it's feasible

10 right now with this material for the test lab or the

11 manufacturer to achieve it properly.

12 Other metals, aluminums, stainless steels,

13 there are other materials I do believe that are

14 technologically feasible to achieve it.

15 Unfortunately for this market that we're

16 looking at, it's a steel market. And preferably a

17 recycled steel to keep the price down.

18 And to get raw steel for this, I think the

19 price would be exclusive.

20 CHAIRMAN TENENBAUM: Let me ask you this.

21 What would you say the functional purpose of having

22 lead in a bicycle is?

¶ Page 182

1 MR. BOGLER: It depends on the product.

2 I mean, lead makes it easier to cut,

3 machinability. So --

4 CHAIRMAN TENENBAUM: Does it make it stronger?

5 MR. BOGLER: Not specifically.

6 Again, it depends on how the process is made.

7 And I'm not a metallurgist, so I don't want to be held

8 to that.

9 But machinability and the tolerance of your

10 threads are significant to the safety of the product.

11 We can go way back to 2008, in talking about the valve

12 stems.

13 And I was here for the presentation that the

14 bike industry made to I believe it was Chairman Nord

15 was there. I don't know if you were there.

16 CHAIRMAN TENENBAUM: I wasn't there.

17 MR. BOGLER: But, you know, valve stem, you

18 know, threads. Something that had been safe for many,

19 many years, we're going to take the lead in it out,

20 reduce the quality of those threads.

21 I'm not saying it can't be done. The industry

22 has done it, got the lead limits down. But we don't

¶ Page 183

1 know what's going to happen in 2-1/2 years, when the

2 kid's riding down the street.

3 I personally have done salt-spray testing.

4 I've tried to do some life testing on products to see

5 if we were going to find something.
6 But doing a lab test and have real life

7 testing is two different things.

8 CHAIRMAN TENENBAUM: So when a bicycle

9 manufacturer starts to manufacture a bicycle, they buy

10 the steel, and probably recycle steel to keep the price

11 down.

12 They don't test that steel before they start

13 in making the bicycle, then? Because it's interesting

14 that you have to take a bicycle apart to do the

15 testing.

16 Why couldn't you test all the components

17 before you received it, or if a bicycle manufacturer

18 had its own third-party laboratory and could test the

19 steel to see that it's below the 100 parts per million?

20 Probably recycled steel has so many

21 variabilities. But --

22 MR. BOGLER: Across the board.

¶ Page 184

1 CHAIRMAN TENENBAUM: Yeah. I'm just curious.

2 MR. BOGLER: To get to the specifics of a

3 bicycle, I mean, I was with you in Wuxi at the CPSC,

4 U.S.-China.

5 Some of the components are made in Wuxi, that

6 ultimately end up on a bicycle that's produced in

7 Shanghai.

8 That component manufacturer, the private

9 labeler in the United States -- and I might be stepping

10 over John here for explain it - but the private labeler

11 who is ordering a children's bicycle -- a 16-inch or a

12 20-inch children's bicycle -- says, "I want a bike, it

13 want it to have gears, I want it to have brakes, and it

14 has to be compliant."

15 The bicycle "manufacturer" in Shanghai then

16 goes out and starts sourcing the components to build

17 that bike.

18 The component manufacturer, who are all over

19 China, or Taiwan, or Laos, or Cambodia, or wherever the

20 component's being made, they go out and source the raw

21 material for those components.

22 The actual frame itself is the only thing that

¶ Page 185

1 most of the bicycle manufacturers are making in house.

2 All the rest are being bought from suppliers, and then

3 assembled after they produce the frame and the fork.

4 So yes, they have control over the component

5 part of the bicycle that they build. So --
6 CHAIRMAN TENENBAUM: They're outsourcing.

7 MR. BOGLER: Then when CPSC goes to the

8 bicycle importer, private labeler, and says, "We need a

9 third-party-compliant test," they get the bicycle

10 manufacturer to send it to me and I test it.

11 So what I get is a complete bicycle. I have

12 to test it to the 1512 for the bicycle regulation. I

13 have to do the 1303 and the other areas of it, as well.

14 So I get the complete bicycle, go through all

15 the testing of it.

16 And then to get down to the substrate, I have

17 to start pulling all these parts across --

18 Two days from now I'm going to start testing

19 the 2012 children's models. They're being produce in

20 China right now. I'm going to get the first samples in

21 the next couple days.

22 These bikes are going to be hitting the market

¶ Page 186

1 next year. So again, this is an issue we've talked

2 about timing and clogging up the supply chain and doing

3 many other things.

4 So going to that supplier, I would have had to

5 get the product from the supplier probably two or three

6 months ago, before they get it to the assembler of the

7 bicycle.

8 And the logistics of all that happening, they

9 don't even know what they're going to stack on the bike

10 at that point. So you don't what's going to be coming

11 in.

12 We would be happy to test all the components

13 before they got assembled. I mean, I am a test lab,

14 and I'd like to do that.

15 MR. NEDEAU: I would clarify. I know on

16 behalf of all the member companies that are making

17 children's bicycles, there are responsible efforts

18 underway for them to go to their suppliers of the

19 component pieces, to have those suppliers comply.

20 And we've made great progress as it relates to

21 the 300-parts-per-million standard. But the challenge

22 is: Can we do it conceivably at 100 parts per million?

¶ Page 187

1 And that's where it's a really daunting challenge.

2 You know, that's where up the supply chain,

3 I'm sure there are significant struggles associated

4 with having that come back compliant at the 100 parts

5 per million for metallic parts.
6 CHAIRMAN TENENBAUM: Thank you. Mm-hmm,

7 metallic parts.

8 Commissioner Moore?

9 COMMISSIONER MOORE: No.

10 CHAIRMAN TENENBAUM: Commissioner Nord?

11 COMMISSIONER ADLER: I'd like to pass at this

12 time, if you could come back.

13 CHAIRMAN TENENBAUM: Okay.

14 Commissioner Northup?

15 COMMISSIONER NORTHUP: Yes.

16 I'd like to ask Mrs. Chapman. How much does a

17 set of your keys cost?

18 MS. CHAPMAN: For a consumer?

19 COMMISSIONER NORTHUP: Yeah.

20 MS. CHAPMAN: Twenty-four dollars.

21 COMMISSIONER NORTHUP: And how many have you

22 sold?

¶ Page 188

1 MS. CHAPMAN: I just launched in December, and

2 probably around 400 sets.

3 COMMISSIONER NORTHUP: Okay.

4 MS. CHAPMAN: And I'm only selling them on my

5 website right now.

6 COMMISSIONER NORTHUP: And how much did you

7 invest to start it?

8 MS. CHAPMAN: Around $50,000.

9 COMMISSIONER NORD: And have you sold to any

10 of the big chains?

11 MS. CHAPMAN: Not yet, because I'm not selling

12 retail yet.

13 COMMISSIONER NORTHUP: So it's $24.00 for

14 three keys on a ring?

15 MS. CHAPMAN: Stainless steel.

16 COMMISSIONER NORTHUP: You know, I just feel

17 like, since this is a public meeting, I ought to ask

18 the question, or at least get an explanation:

19 My understanding is that the European Union

20 has a standard of 90 parts per million of soluble lead.

21 So actually something could be much higher in the

22 substrate than 90 parts per million.

¶ Page 189

1 And so as you keep saying, the United States

2 should get down to European standards, the fact is,

3 they may have 500 parts per million, and it could still

4 meet this 90-parts-per-million solubility.

5 MS. CHAPMAN: Right. So I think that that's a
6 very good point. But I also think that across the

7 board, my understanding is that they have higher

8 restrictions on other toxins as well as lead.

9 COMMISSIONER NORTHUP: Well --

10 MS. CHAPMAN: So I'm talking across the board

11 what I feel comfortable for as a consumer, and I openly

12 admitted to being neurotic.

13 So (laughing) --

14 (Simultaneous conversation.)

15 COMMISSIONER NORTHUP: Let me state again,

16 it's solubility standards.

17 MS. CHAPMAN: Right.

18 COMMISSIONER NORTHUP: Which means it's

19 related to the risk of a child actually absorbing it.

20 Compared to our standards for lead, it's the only one

21 we have a statutory limit and the only one that's a

22 subject is not a solubility.

¶ Page 190

1 So I just think for anybody that sees this,

2 it's really important that they understand that our

3 standards very likely are stricter than the Europeans.

4 And also, did you know that the Europeans do

5 not require third-party testing and certification?

6 MS. CHAPMAN: But for most of the companies

7 that I will tell you I purchase from here, they go

8 through a pretty elaborate questioning process of the

9 toy companies --

10 COMMISSIONER NORTHUP: That's fine. That's

11 fine --

12 MS. CHAPMAN: In the product that they

13 sell --

14 COMMISSIONER NORTHUP: That's different than

15 actually sending your component out and having a

16 third-party test.

17 I just think that, you know, the fact is that

18 our standards -- it's important that we not leave

19 anybody watching this with the idea that somehow at 300

20 parts per million, and not having the third-party

21 testing and the certification, that our standards are

22 less than European standards.

¶ Page 191

1 That's all.

2 That's the main thing. You know, I applaud

3 you. I completely agree, as the mother of six

4 children, keys are just an absolutely fascination to

5 kids, and most moms reach right in their purse and they
6 pull them out, and they hand them to their child in the

7 grocery cart;

8 So that they can play with something, while

9 they're pushing them. And I've always thought viruses.

10 It wasn't until I got here that I thought, "Oh, my

11 gosh, lead."

12 I'd point out that they're sitting in the

13 grocery cart, that's probably loaded with lead.

14 And so I don't know that putting your keys

15 away necessarily protects them.

16 MS. CHAPMAN: Yeah.

17 COMMISSIONER NORTHUP: But I think toy keys,

18 if you can afford $24.00 for what's similar to a

19 rattle, I think it's a nice alternative.

20 CHAIRMAN TENENBAUM: Commissioner Adler?

21 COMMISSIONER ADLER: First of all, I want to

22 thank of you for your testimony. I thought it was

¶ Page 192

1 extremely enlightening, and I very much appreciate it.

2 And just to remind all of us, the test that we

3 face, which was so accurately described by Mr. Locker,

4 is not a free test, where the burden is on us, in a

5 certain sense:

6 The law says, that's handed to us by the

7 Congress, that we must move from 300 to 100, unless we

8 determine that moving to 100 is not technologically

9 feasible.

10 And so the testimony you all have given today

11 is very, very helpful to me. It's the kind of data

12 that I feel the need to listen to.

13 And Mr. Bogler, if you're about to test for

14 the 2012 models, I'd be particularly curious to hear

15 what your results are, because they're supposed to be

16 needing it for the 100 parts per million;

17 And I'd be very curious what you think they're

18 doing.

19 So again, if I might make a request, at least

20 informally, to hear any data that you've come up with,

21 I'd be very interested in hearing that.

22 One of the questions I guess I would ask at

¶ Page 193

1 this point -- and again, I want to reference the

2 statute -- the statute has a fairly interesting

3 definition of the term, "technologically feasible."

4 And of course, Mr. Locker, I bet, could recite

5 it by heart.
6 But one of the things that directs us to do,

7 if we were to make these findings, is with respect to

8 products or product categories.

9 And so if I might start, at least with Mr.

10 Locker, suppose you were sitting in my shoes and I were

11 to listen and be convinced by a lot of the points made

12 here today.

13 First of all, how should we do that? Should

14 we do it, say, it sounds like vinyl and plastic not an

15 issue for anybody, but are we to say the product

16 category is all recycled, non-heterogeneous metal

17 alloys?

18 Are we to say something broader than that?

19 Are we to say limited to bicycles?

20 I'd really appreciate it if you had any idea

21 how we could craft something, assuming we were to try

22 to craft something.

¶ Page 194

1 MR. LOCKER: I think that would be a good

2 start.

3 Because I actually think the description of

4 the problems encountered by the bicycle industry are

5 really a description of problems encountered by any

6 industry that uses a variety of metal alloys.

7 So understanding that, I would actually have

8 to narrow it a little further, in all honesty, than

9 just saying "All metal alloys."

10 Because certainly we would want to be mindful

11 that we were not dealing with perhaps a small part that

12 was capable of being ingested, such as a metal jewelry,

13 that created some problems and led to some of the

14 restrictions in the law.

15 And in our industry, and at least for most of

16 the children's products, for the young children, we

17 can't have small parts for children under three.

18 So I think you're going to have an exception

19 for children under three, no matter what.

20 And then when we move above that age range,

21 however, where you have the child, even the precocious

22 child that might mouth or lick things, or the aberrant

¶ Page 195

1 child subject to pick a disease, you just have to look

2 to the reasonable standard in the marketplace.

3 In that area, I think we all face the same

4 problems in a variety of industries that the Bicycle

5 Industry faces.
6 And I think you want to have a practical

7 solution focused on metal alloys, particularly since,

8 as the Chairman noted -- very accurately, by the

9 way -- in the test data, there was such variability in

10 the testing.

11 And I do wish we did have the fastener

12 industries and the steel industries and a metallurgist

13 here to talk about what they said, so I don't have to

14 talk hearsay.

15 COMMISSIONER ADLER: If I might interject for

16 one brief second, I talked to somebody from the Staff

17 during the break, and if I understand correctly, we are

18 going to get a submission from the American Iron and

19 Steel Foundation, or whenever it's called.

20 So I look forward to that.

21 MR. LOCKER: Oh, terrific. And we do too.

22 COMMISSIONER ADLER: I'm sorry, I didn't mean

¶ Page 196

1 to interrupt.

2 MR. LOCKER: Oh, no. I was just saying, so in

3 that regard, I think those are sort of the problems.

4 I do think the test labs, both here and in the

5 previous panel, did touch very accurately on some of

6 this issue:

7 That you can take a piece of metal alloy and

8 test it in one location and get a different result in a

9 another location.

10 And then you have this variability that was

11 touched upon in the previous panel, which the Chairman

12 did talk about, up to 46 parts per million, even if

13 it's reduced, creates an issue.

14 And as you know, I would argue that Congress

15 does allow you to have some variability. Because when

16 they adopted the ASTM F-963 Toy Standard, and the other

17 heavy metals provisions in that standard, built into

18 that SOP is a reasonable allowance of variability to

19 smooth out that testing.

20 And I would urge you to have the same policy

21 for enforcement.

22 MR. WOLDENBERG: May I add to this?

¶ Page 197

1 I think that a very relevant consideration is

2 what my associate mentioned, that small bicycle

3 manufacturers have left the market.

4 This is an issue that's been brought to this

5 Commission's attention for three years running. I
6 think certainly carving out metals will be appropriate

7 and appreciated by industry.

8 But I think that you shouldn't take false

9 comfort in thinking it's solving the problem, unless

10 you're indifferent to what happens to small business.

11 If this is intended to be a gift to my

12 industry associates, Hasbro and Mattel, craft it

13 narrowly and make us meet the standard irrevocably on

14 everything else. And then we will just slowly winnow

15 out.

16 It's a gift to big business.

17 If you make the standards so tight that only

18 the greatest experts can meet it are the people with

19 the greatest resources, as you've received testimony

20 today, you should at least do that, knowing what you're

21 doing, which is killing small business.

22 COMMISSIONER ADLER: I certainly appreciate

¶ Page 198

1 that comment.

2 And I did notice in your outline, at least,

3 Mr. Woldenberg, you used the following phrase:

4 "Technological feasibility, an utterly commercially

5 unrealistic standard."

6 Could you elaborate on that?

7 MR. WOLDENBERG: Yes.

8 COMMISSIONER ADLER: I'd appreciate it.

9 MR. WOLDENBERG: The reason it's commercially

10 unrealistic is that we have to make decisions based on

11 money. We don't have an infinite amount of money.

12 An example of that is: Many months ago the

13 CPSC came out with a list of materials that we could

14 use freely in our toys, because they're lead-free.

15 And that list included: Gold, platinum,

16 palladium, rhodium, iridium, ruthenium, diamonds,

17 rubies, and so on. And surgical steel.

18 That wasn't really very helpful, because we

19 really can't replace plastic in our toys with gold and

20 platinum, and encrust it with jewels, and sell it for

21 $18.00.

22 So I believe that anything can be achieved for

¶ Page 199

1 money. So technologically feasible is commercially

2 unrealistic, because I'm limited by money. And my

3 customers are limited by money.

4 So even if I had an infinite amount of money,

5 my customers don't.
6 So I can't in good conscience, hand on the

7 Bible, tell you that anything that you want me to

8 achieve can be achieved.

9 And "possible" is not the same thing as

10 "consistently."

11 So there's a great deal of randomness, if my

12 standard is what's possible, because I'm not sure I can

13 do it consistently.

14 The phrase I've used to illustrate why

15 technologically feasible is unrealistic is the saying,

16 "If Rolex can do it, Timex must do it."

17 Rolex charges $11,000 for a watch. Timex

18 charges twenty bucks. It's not the same ball game.

19 COMMISSIONER ADLER: That's a very thoughtful

20 answer, and I certainly appreciate it.

21 I guess what I'm still not clear about is:

22 Are you telling me that we should ignore the law and

¶ Page 200

1 not follow it? Or are you telling me that I should

2 interpret it in a particular way?

3 Because I'm not prepared, at least at this

4 point, to read a definition of "technologically

5 feasible" and ignore what the law directs me to do.

6 So I guess my question is: How would you

7 interpret those terms? It sounds like you're

8 interpreting them as making it impossible for you to

9 meet, and you're asking me not to comply with the law.

10 And maybe I'm misinterpreting what you're

11 saying.

12 MR. WOLDENBERG: Well, as you know, I'm a

13 lawyer. And I know you're a lawyer. And so I'm not

14 going to advise you not to follow the law.

15 The law, however, has irrevocable

16 consequences. And so there's a question of conscience

17 here.

18 There are some things that I think everyone on

19 the Commission knows, that I think the CPSC has done,

20 that has not rigorously followed the law.

21 And I'm a little confused by sometimes when

22 the CPSC follows it strictly and sometimes when the

¶ Page 201

1 CSPC follows it not so strictly.

2 And as a lawyer, I'm a little confused as to

3 what counts and what doesn't.

4 But in terms of this and your specific

5 question -- and it's an extremely important
6 question -- if you're going to sell small business down

7 the river, then maybe if you focus your energy on

8 getting Congress to loosen up the knot;

9 Because you can't, in good conscience, do what

10 they what you to do. They may have done it in good

11 faith, they may have done it for the right reasons in

12 their heart;

13 But it's wrong. And we can't do it.

14 COMMISSIONER ADLER: Thank you very much. I

15 appreciate that.

16 Just one last question, if I might. And this

17 would be of the group at large.

18 Assuming again that we were to make a

19 determination with respect to some group of things that

20 we would label as a product category, the statute also

21 directs us on an ongoing basis to revisit this from

22 time to time.

¶ Page 202

1 And so I guess one question I would have:

2 Given what you've all acknowledged was a

3 fairly dramatic change in the marketplace, do you have

4 any idea whether the market ultimately will be able to

5 shift to meet the 100 parts per million?

6 Do you have any sense, assuming that it is

7 difficult or impossible to do, whether that is on the

8 horizon that we will reach that hallowed ground?

9 MR. WOLDENBERG: I can tell you the data I've

10 given you says that we're more than 98 percent of the

11 way there.

12 And any responsible company that's

13 manufacturing for this industry is going to make very

14 strong, good efforts to always improve their products.

15 If you removed the law and made it subject to

16 nothing, our products would not degrade. We would

17 continue to make every effort to make them better.

18 And I believe that our products will continue

19 to get better. I want our products to get better. And

20 of course, I have as much concern as anyone in the

21 room, if not more, to the health and safety of

22 children.

¶ Page 203

1 So I really think that you can anticipate that

2 things will improve. What I'm arguing for is: Let us

3 survive financially as that happens.

4 COMMISSIONER ADLER: Thank you all very much.

5 MS. JONES: May I address Commissioner Adler's
6 question for just a moment on the legal standard of

7 feasibility?

8 I would commend to you a slightly different

9 approach than my colleague did; because I think that

10 Congress intended you to evaluate feasibility, not as

11 an abstract theoretical principle, but as a practical

12 construct in the sector that you are studying.

13 So to look at bicycles, for example,

14 absolutely it's technologically feasible to meet 100

15 PPM if we make the bike out of carbon fiber. But that

16 will be a several-thousand dollar bicycle, it will not be sold

17 at Toys R Us, and it is not accessible to the majority

18 of American families.

19 If that is the legal standard, then we're

20 done, we can go home. Because you will conclude that

21 is technologically feasible.

22 I don't think that's what Congress intended

¶ Page 204

1 you to do. I believe that Congress intended you to

2 look at a commercially valuable and socially valuable

3 segment in the market, children's bicycles, which, by

4 the way, have their own health and recreational value.

5 They are not without their own social utility

6 in encouraging exercise, and other things that we want

7 our children to do. And the tradeoff between that

8 value and depriving them of that value because somebody

9 might touch the value and put it in their mouth, is a

10 tradeoff that I think has to be part of the equation.

11 But to the question at hand: "What is

12 technologically feasible?" I think not only may you,

13 but I would say you must evaluate that in the context

14 of an existing market segment that is socially useful,

15 and decide whether it is technologically feasible for

16 that market segment.

17 And I think we've given you evidence that

18 today, this year, for this market segment, it is not.

19 Might it be in a couple years? It might be.

20 When we were here two years ago, asking this Commission

21 to give relief from the then-600-part-per-million

22 standard, we didn't know where we would be in 2011.

¶ Page 205

1 Tremendous progress has been made in finding

2 substitute materials, covering up, using the

3 accessibility interpretations to cover some of the

4 materials.

5 But we're not all the way there yet.
6 And the frightening thing to me is that, as a

7 lawyer, just looking at Mr. Bogler's evidence that

8 along the same material, the same piece of metal,

9 formed in the same factory process, can have passing

10 and failing results, and what that means for a

11 reasonable test program, and what does that mean to a

12 manufacturer?

13 He relies on three tests, and the fourth one

14 is the bad one. He relies on five tests, the sixth one

15 is the bad one.

16 There's no end to that. That's part of

17 feasibility as well.

18 And I would urge you to take all of that into

19 account as you make your decision.

20 COMMISSIONER ADLER: I really appreciate that

21 answer. And I promise you I will ponder this as

22 carefully as I possibly can.

¶ Page 206

1 I will admit that I lie awake at night,

2 looking at these alternative definitions.

3 And it starts out, "If it's commercially

4 available. Oh, but if that doesn't work, then if

5 there's technology that's commercially available.

6 And oh, by the way, if that doesn't work, if

7 there are industrial strategies that are commercially

8 available. And if none of that works, then

9 alternatives to that."

10 And you look at that and you say, "I know

11 Congress was trying to send us a strong signal. I'm

12 not quite clear what the signal is."

13 But I do think that -- and taking all of what

14 you said -- there's got to be an element of common

15 sense in all of this.

16 And I certainly think the Commission will

17 bring that to bear.

18 So again, I really thank you and appreciate

19 that answer.

20 MR. LOCKER: I would just add one thing, while

21 you're lying awake at night to think about.

22 That a synonym for feasible is also another

¶ Page 207

1 word they used in the statute: Practicable.

2 And so I think practicability covers the

3 concerns that my colleagues here have referenced. And

4 representing a lot of industries, we have members that

5 make stainless steel keys, and bicycle-like products
6 and educational products. And they run the gamut.

7 And it's not a question of big or small or

8 whether it's viable or not. If we could achieve it in

9 a practicable way, we would have.

10 Thank you.

11 CHAIRMAN TENENBAUM: Commissioner Nord?

12 COMMISSIONER NORD: Yeah.

13 Just following up on this conversation, Erika,

14 your comments with respect to feasibility, did you mean

15 them to be limited just to the Bicycle Industry? Or

16 are we talking about any product that uses metal

17 alloys?

18 MS. JONES: Well, I think as a legal matter,

19 you could go either way on it.

20 COMMISSIONER NORD: You could, okay.

21 MS. JONES: I think the statute says, as

22 Commissioner Adler put it, products or product

¶ Page 208

1 categories.

2 And you could look at a product category at

3 the completed bicycle level. You could look at it,

4 although we are not asking for that relief, because the

5 vinyls and plastics are not in need --

6 COMMISSIONER NORD: Yeah. Okay --

7 MS. JONES: But you could do that. You could

8 look at the component. Or as Mr. Bogler described,

9 there is second-, third-, fourth-, fifth-tier

10 suppliers.

11 And I think you have the discretion in the

12 statute to make a horizontal slice by market segment,

13 or a vertical slice by what tier of the supplier.

14 And I think you have the discretion to do

15 either or both.

16 COMMISSIONER NORD: Okay.

17 COMMISSIONER NORTHUP: Can I? Oh, no, no, go

18 right ahead.

19 COMMISSIONER NORD: Oh, please, I yield.

20 COMMISSIONER NORTHUP: Can I ask you, if you

21 did it component by component, what would that mean in

22 terms of having to prepare, I guess, a petition or a

¶ Page 209

1 request or an argument, component by component, company

2 by company?

3 I assume they don't all use the same

4 suppliers. And would that become prohibitively

5 expensive, if we did not make an across-the-board
6 determination?

7 And I might carry it further.

8 In other words, if your association of

9 bicycles can't argue for all of them, across the

10 board, but instead each one of your members had to

11 argue for their specific bicycle and their specific

12 component, would that become prohibitively expensive to

13 make that argument to prove a negative "We don't have

14 everything right now that we could substitute"?

15 And then this company over here, they happen

16 to have the stem of the tire, but somebody else doesn't

17 have the spoke, and somebody else doesn't have the --

18 MS. JONES: I think I can safely say that the

19 BPSA membership would prefer to see you do this at the

20 highest possible level, and not require individual

21 petitions from individual companies.

22 BSPA represents over 90 percent of the

¶ Page 210

1 children bicycle manufacturers that sell in the United

2 States.

3 That's still a number that are not members,

4 who aren't represented here today, who may not have

5 even heard of you, and who would be without any

6 reasonable relief, if you went that route.

7 Not to mention the burden on your own staff of

8 having to process all of that paperwork.

9 I think you have the discretion, and I think

10 it would be sensible to exercise it to make a judgment

11 on the testimony at something that would be

12 industry-wide, but not necessarily at an entire

13 component.

14 I don't think you have to say bicycles are

15 exempt. I think you could say metallic products used

16 in bicycles. There's a definition of bicycle that's

17 already in 1512.

18 I think you could do it that way.

19 COMMISSIONER NORTHUP: Well, if I just carry

20 forward, then.

21 Besides just bicycles, which you all are here

22 to argue for, an industry, and you've done so well

¶ Page 211

1 doing that or making it aware, can you imagine many,

2 many other products that aren't as big or substantial

3 or as expensive as yours, that also use, say, ball

4 bearings, and cogs and wheels -- I'm sorry, I'm not an

5 engineer myself -- that might not have the resources or
6 be as visible?

7 In other words, if you just make it across the

8 industry, what does that do to all the stranded

9 products that aren't of such a large category?

10 MS. JONES: Well, you're right. And many of

11 them aren't represented in a trade association at all,

12 and are not really in a position to come and petition

13 you for that kind of relief.

14 And that's why I said that I think you can go

15 both vertically and horizontally. You could say "All

16 ball bearings." You could have definitions of metal

17 that certainly we on this panel and others earlier in

18 the day could help you craft, or respond to comments

19 on, that could be a material-based exclusion;

20 Or a material-based interpretation of the

21 availability of feasible 100-PPM standard could be

22 applied at a material level, and not at a product

¶ Page 212

1 level.

2 I think you could do either, or both.

3 COMMISSIONER NORTHUP: Well --

4 MR. WOLDENBERG: Commissioner Northup? I'm

5 sorry.

6 There are examples that you're seeking. And

7 they're in the education industry. There are a fairly

8 substantial number of companies that make versions of

9 bicycles, make trikes and all kind of contraptions for

10 transporting young kids.

11 And they're aimed at schools, which is a

12 small-niche market. These are low-, low-volume

13 manufacturers.

14 Those companies that you're talking about, the

15 little ones, they do exist. And they're in many

16 industries. That's just something I happen to know.

17 COMMISSIONER NORTHUP: And the feasibility of

18 them filing a petition would be much more --

19 MR. WOLDENBERG: There's a number of reasons

20 why companies might find a petition to be not feasible.

21 One is the scale of their business being too

22 small. The other is: If you look, for example, at my

¶ Page 213

1 business, we have 15 hundred products. I'd have to

2 file 15 hundred petitions.

3 I have customers and competitors that are

4 scaled up from there.

5 Science companies in particular. We've had
6 science companies testify here before on panels. They

7 have zillions of items. I mean, it's just not

8 possible.

9 MR. LOCKER: Yes, being with multiple

10 industries, I think it just makes the most logical

11 sense to focus it on materials and then maybe perhaps

12 sub-categories within those materials, in the metal

13 category.

14 I think that's the only logical way to do it.

15 Otherwise, you're going to invite further chaos, and

16 we're trying to avoid that.

17 COMMISSIONER NORD: So do I take it then, that

18 it's the view of this panel that metals is really the

19 only problem, and that recycled plastics is not an

20 issue?

21 MR. WOLDENBERG: I can't say that. We do sell

22 recycled plastics, and it's a constant concern of mine

¶ Page 214

1 that it's going to burn me.

2 Right now we test every single lot, simply for

3 the plastic.

4 COMMISSIONER NORD: Mm-hmm.

5 MR. WOLDENBERG: Which is really an excessive

6 amount of testing.

7 COMMISSIONER NORD: You test it internally?

8 Or do you have a testing --

9 MR. WOLDENBERG: No, we can't afford, nor can

10 we manage an internal lab. So we use outside.

11 COMMISSIONER NORD: Mm-hmm.

12 MR. WOLDENBERG: As I'm sure anyone who's, you

13 know, eco-conscious or even the marketing

14 possibilities, if that's your motivation, there's a

15 desire to incorporate as much as we can to re-use what

16 we can.

17 Vinyl on wires in educational products is very

18 often recycled. No one's chewing on the wires used in

19 electricity kits. That's behavior that should be

20 encouraged. And it's not making anyone, it's not

21 harming anyone.

22 COMMISSIONER NORD: What, the chewing on the

¶ Page 215

1 wire?

2 MR. WOLDENBERG: I'm sorry?

3 (Simultaneous conversation.)

4 COMMISSIONER NORD: Oh, sorry.

5 MR. WOLDENBERG: So, but you know, those types
6 of materials that you have to source virgin, and it

7 just doesn't make a lot of sense, but it's going to

8 cost more.

9 COMMISSIONER NORD: Several of you touched on

10 the cost issue.

11 Rick, you said that it would be extreme cost

12 to go down to 100 parts per million. Rick, you said

13 your costs will increase by ten to 20 percent. The

14 Bicycle Industry referenced cost as well.

15 I'd like to figure out if there's some way to

16 quantify it. For example, Rick, I'd like to understand

17 better the ten to 20 percent figure, what goes into it,

18 first.

19 And then secondly for the Bicycle Industry,

20 just using a real-life example, because of the lead,

21 because of the CPSIA, I understand you've now

22 redesigned the Schrader valve.

¶ Page 216

1 What was the cost of doing that to cover the

2 brass screws that nobody sucks on, in any event?

3 Well, it's a two-part question. Rick, why

4 don't you go first? And then.

5 MR. WOLDENBERG: Okay. Well, I think that the

6 reason costs are going to go up is partly, I think,

7 reflective of factories' concern that getting the more

8 purified plastics will be more expensive.

9 We certainly see, as volume shifts over, that

10 those costs abate.

11 Where I believe that the costs will be

12 permanent is in the cost of surveillance, so there will

13 be substantially higher surveillance. And there will

14 be substantially higher risk. And they have to charge

15 us for that.

16 So waste is the biggest cost that I think

17 won't go away.

18 When I was at Toy Fair last week, a friend of

19 mine was telling me about their sad tale, when they

20 sold some materials to a major U.S. retailer, only to

21 find out that a little tiny sticker on the thing had,

22 in the opinion of the test lab, too much phthalates.

¶ Page 217

1 So of course, the product was rejected. It's

2 not saleable. I mean, the whole lot is thrown in the

3 garbage, over a little tiny sticker.

4 And you might say, "Well, he shouldn't have

5 put that sticker on." But you hear these stories too
6 frequently. And it may be reflective of the complexity

7 of what we do.

8 You know, I appreciate your views on how we

9 should buy. But you know, I have 15 hundred catalog

10 items and really thousands of components. And there's

11 a big difference between having one product and

12 thousands.

13 The complexity is exponential, grows

14 exponentially.

15 And so I just can't imagine, based on how we

16 run our business, that this is really, in truth,

17 controllable.

18 If you look at, for instance, the error that

19 Six Sigma companies make, how frequently they make

20 errors, it's tasks. I think they make -- I have those

21 charted, I don't have it with me, I'm sorry -- but Six

22 Sigma companies like Nokia, you know, they might have

¶ Page 218

1 to throw out one phone per million;

2 But if you add up all the tasks, take all the

3 products and all the components and multiply it by all

4 the requirements, you begin to see all of our annual

5 tasks.

6 It's like as bad as what Nokia faces. And

7 we're not Six Sigma.

8 Most companies in our industry are probably

9 between Three and Four Sigma. The probability of

10 failure is so huge -- and what I can't tell is what I'm

11 going to fail on.

12 So if I fail on something small, well, I can

13 absorb that. But if I fail on something big.

14 So those are the costs that I can't tell you I

15 have a solution to. Now maybe I'll figure it out.

16 We'll certainly try.

17 But there's going to be a lot of costs

18 involved in figuring it out. More people, more money

19 expended.

20 And that's a cost.

21 COMMISSIONER NORD: Well, but if you fail on

22 something big, Congress has made the policy decision

¶ Page 219

1 that lead at a particular level is harmful.

2 And that was a political decision that

3 Congress made, perhaps based on science, perhaps based

4 on politics. We'll let others in other settings debate

5 that.
6 But if you fail on something big, isn't there

7 a safety implication there?

8 MR. WOLDENBERG: Well, we're talking today

9 about lowering it from 300 to 100. So now, you're

10 asking me, do I think 100 is the health threshold.

11 And I addressed that earlier and said that I

12 believe that there is an absence of documented injury

13 from lead in substrate, particularly at 100 parts per

14 million or 200, or even 300.

15 And even if there was a documented pool of

16 known victims, that could be identified and could be

17 studied for mechanism, there is no causal link between

18 the types of products that we make and those

19 hypothetical or conjectural injuries.

20 So I don't really think this is about health

21 and safety. I think this is about compliance with an

22 arbitrary standard.

¶ Page 220

1 COMMISSIONER NORD: Okay.

2 Now you were going to discuss the Schrader

3 valve?

4 MR. NEDEAU: Yeah. Commissioner Nord, yes.

5 Specific to the Schrader valve that you

6 referenced, there are quotes available now from

7 Schrader valve suppliers, that are about 28 percent

8 higher than a, you know, today compliant Schrader

9 valve.

10 The Schrader valve I'm referencing would be

11 achieving that 100 parts per million standard. But

12 that's before the entire industry transitions that way,

13 and then we don't know what the cost associated with

14 the product then, given the demand, would be.

15 COMMISSIONER NORD: So it's gone up 28

16 percent?

17 MR. NEDEAU: Yeah.

18 COMMISSIONER NORD: Are you aware of anyone

19 who's ever been harmed by putting air in a bicycle tire?

20 COMMISSIONER NORD: No, Commissioner, we're

21 not.

22 And I would note that that increase in price

¶ Page 221

1 was to get to 300. That is not what it would be to

2 100. We don't know if it's even possible to get a

3 valve that could consistently comply at 100.

4 That's the price increase that we've already

5 absorbed to get down to 300.
6 COMMISSIONER NORD: Okay.

7 And one other question. What is the status of

8 bikes sold at resale? And you find them at a charity,

9 for example, or I'm trying to give my child a bike and the

10 child strangely enough grows, and grows out of them?

11 Am I going to have a problem, if I want to

12 find a bike that's not a new bike?

13 MS. JONES: I don't think there's any question

14 that bikes built prior to the enactment of the CPSIA

15 that had valve stems, spoke nipples, and other items

16 that we've identified to you in numerous filings here,

17 that were built of components that were not subject to

18 the standard at the time, are not going to meet the

19 standard.

20 I don't think that we're prepared here today

21 to tell you what's happening in the after-market. I

22 don't think we know, sitting here right now.

¶ Page 222

1 But I can assure you that if you find a used

2 bike in your garage from ten years ago, it's going to

3 have more than 300 parts per million lead on one or

4 another component on it, because it was built prior to

5 the enactment of the standard, and of course, you know

6 the Commission's interpretation on the resale or

7 products after the effective date of the standard.

8 MR. LOCKER: Commissioner Nord, just like

9 Commissioner Adler lies awake at night, thinking about

10 defining technical feasibility, I lie awake at night,

11 worrying about the consequences in the marketplace of a

12 retroactive application of 100 parts per million;

13 Because I first-hand saw what it was like,

14 when we originally dropped to 600 parts per million for

15 substrate, notwithstanding the state in compliance.

16 And in some of our industries, it resulted in

17 more than billion dollars of loss.

18 So that's something that not just in the used

19 marketplace, but in the marketplace going forward,

20 worries me.

21 And you know, I did note the general counsel's

22 opinion that perhaps you can have a different opinion

¶ Page 223

1 on a go-forward basis in arguing Congressional intent,

2 as they drop down from 600 to 300 to 100 -- if that's

3 possible.

4 The would be terrific. If not, I think we all

5 have to talk to our Congressmen.
6 CHAIRMAN TENENBAUM: And you might be

7 comforted in knowing that all five of us are on record in

8 stating that we think 100 parts per million should be

9 applied only prospectively and not retroactively.

10 And we're all on the record as saying that to

11 Congress.

12 COMMISSIONER NORD: We touched a little bit on

13 the whole difference between a solubility standard and

14 a content standard.

15 And that certainly raises in stark terms the

16 whole question of harmonizing standards across

17 jurisdictions.

18 Unfortunately the trend seems to be going the

19 other way, and to my mind, I think that is a very,

20 very, very bad thing for safety.

21 I do think that safety would be advanced if

22 the European standard, the U.S. standard, the Canadian

¶ Page 224

1 standard, other major jurisdictional standards, were

2 substantially equivalent, one to the other; so that we

3 could have one test, and you could market in various

4 jurisdictions.

5 Having said that, I'm wondering if any of you

6 know now or could you supply for the record, are there

7 conflicting standards within the federal government

8 that we should be aware of?

9 Or well, I guess if we put this in place, we

10 will preempt conflicting state standards.

11 But are there other federal jurisdictions who

12 address the whole question of recyclability in using

13 recycled materials, or using lead in a way that

14 accomplishes an objective -- for example, minimizing

15 the corrosion due to rust -- in ways that are

16 inconsistent with what the CPSIA directs us to do, with

17 respect to this?

18 MR. LOCKER: Well, I think if you keep the

19 record open, we'd like to get back to you on more of

20 that information; particularly as it involves what

21 we'll call "intra-government alignment." I think

22 that's the term now, not harmonization, they call it

¶ Page 225

1 global alignment, intergovernmental alignment.

2 So certainly we'll get back to you on that.

3 In terms of materials and inconsistency in

4 performance regulations, where you may need to use a

5 material, you know, I'd look at some of the items that
6 you have joint jurisdiction over with the National

7 Highway Traffic Safety Administration;

8 And their own corrosion resistance

9 environmental conditioning requirements, which may

10 require certain treatments of, or certain materials to

11 be used to make them corrosion-resistant and

12 crash-resistant.

13 And to me, that would be the greatest concern.

14 We did see that as an issue, when some states

15 were enacting limitations. And most of those states

16 have backed away from that.

17 I note that the current administrator of

18 NHTSA, David Strickland, who was a former majority

19 counsel on the Senate Commerce Committee, told us that

20 that would never happen, because he never thought CRS

21 would ever fall within the scope of the CPSC.

22 So we'll get back to you on that.

¶ Page 226

1 CHAIRMAN TENENBAUM: Okay.

2 And I will be asking our general counsel the

3 length of keeping the record open, what our options

4 are, and we will be letting people know.

5 But I know that staff have questions too, or

6 may have any questions. Dominique, or Hyun, or Kris?

7 MS. KIM: Okay. I'll go first.

8 You've talked a lot about the 100 parts per

9 million and the technological feasibility of meeting

10 the 100 parts per million.

11 The statute also requires that if the

12 Commission finds that you can't meet the 100 parts per

13 million, that they consider alternative lead limits

14 under 300 parts per million.

15 And I'd like to know if you've considered some

16 alternative lead limits that you could reach? Perhaps

17 250 or 200? Or some other figure that you can meet

18 consistently and realistically, to use Rick's words?

19 MR. LOCKER: Yeah. Well, I would just note

20 that since there are two factors that were touched

21 upon, not just the total limit, but also the

22 variability in testing and method, that you have to

¶ Page 227

1 marry those two together, when you consider: Can you

2 go to lower limits?

3 Because those are going to have an impact.

4 Most of the testing in terms that we have

5 looked at in the industries that we've talked to in the
6 supply chain have focused on the 300/100 benchmark.

7 And the problem we see so far is that there's

8 a lot of variability, just as the Chairman questioned

9 in the slides on some of the testing in bicycle parts;

10 It runs a broad range in that these very, very

11 low levels, when you layer in the differences and then

12 layer in further the variability, it becomes very

13 problematic, until you have a completely sanitized,

14 available supply chain that can represent component

15 compliance.

16 And we're just not there yet on some of these

17 metallurgical materials. From what we've seen.

18 MR. WOLDENBERG: I'd like to suggest

19 that -- I'd just like to note that the 150 or so people

20 that work at our company would like to keep their jobs.

21 And so my suggestion would be that you stay

22 that decision for five years: You leave it at 300

¶ Page 228

1 parts per million, and that you try to accumulate

2 injury statistics in that period of time, to see if

3 there's any economic value in imposing costs on me.

4 I believe there's a legal requirement in some

5 parts of the federal government that any change in

6 regulation pass a cost-benefit analysis.

7 And so before you impose certain costs on me

8 to change my business to meet a lower standard, you'd

9 be able to demonstrate that there be a benefit that has

10 an economic equivalent.

11 And I don't think you can do that without

12 waiting.

13 CHAIRMAN TENENBAUM: Any other questions?

14 MR. NEDEAU: The bike industry has not had

15 that discussion yet about something between 300 parts

16 per million and 100 parts per million.

17 MS. WILLIAMS: I have a question about

18 commercially available.

19 In the standard, it says that technological

20 feasibility, the definition is: Commercially available

21 to manufacturers or otherwise, available within the

22 common meaning of the term.

¶ Page 229

1 So what factors or considerations should we be

2 evaluating to determine this? Basically what's your

3 definition? What is your definition of "commercially

4 available"?

5 MS. JONES: The Bicycle Industry's comments
6 from last September addressed this. And so I'll just

7 very briefly touch on it again.

8 But I think it really is related to my answer

9 to Commissioner Adler earlier. This is the place that

10 Congress gave you the authority to take into account

11 the sector that you're looking at and the cost of the

12 product that's in that sector.

13 It's something that may be commercially

14 available for a product that costs $7,000, is not the

15 same if that same price component is being applied to a

16 hundred-dollar product.

17 And I think this is your opening to consider

18 what we've urged you to do, which is to consider the

19 commercial realities of the cost increase to the price

20 of the product that you're studying.

21 And a 28 percent increase, if that's, in fact,

22 what it turns out to be on a hundred-dollar product, is

¶ Page 230

1 going to take it out of the reach of many families.

2 And we think that's what Congress meant by

3 "commercially available." Not just available, but

4 available at a reasonable price, at a reasonable

5 reliability in the market that the supply will be there

6 when we need it, at a price that is reasonably related

7 to the product to which it will be installed on.

8 MR. NEDEAU: Erika, it's worth noting, too,

9 that you know, that 28 percent cost increase from the

10 manufacturer, multiplies by the time it reaches the

11 consumer.

12 That can become two and three times a price

13 factor, from what the cost factor was from the

14 manufacturer.

15 MR. LOCKER: Yeah. I just believe that to be

16 commercially available, it has to be first of all

17 available, but not in a limited sense of the word.

18 It has to be available widely, and in a

19 competitive fashion, so you don't have bottlenecks in

20 your supply chain. It's not just cost, it's also

21 availability.

22 And when you're talking about -- the more

¶ Page 231

1 common component you're talking about, let's say those

2 nuts and bolts and fasteners -- the bigger the problem

3 you have;

4 Because it's used in so many things.

5 You know, maybe in the defense industry they
6 still make a particular bolt for one particular

7 product. But in the consumer product industry, that's

8 just not available.

9 CHAIRMAN TENENBAUM: Do you have a question?

10 MR. BUTTURINI: Hi, I'm Randy Butturini from

11 the Office of Hazard Identification and Reduction.

12 I've got three questions regarding metals.

13 The first one is: Have any of you come across

14 someone, when you're looking for suppliers, that says,

15 or would project, that there's just not enough

16 industrial capacity to make a low-lead metal to fill

17 all its applications for children's products?

18 (Discussion was held off the record.)

19 MR. LOCKER: Well, actually we did look at

20 that on some of the component materials, at least

21 within some of the industries, like toys and juvenile

22 products, and to some extent some apparel.

¶ Page 232

1 As we sit here today -- we were having those

2 very bottleneck issues in terms of capacity. It wasn't

3 just the capability to produce it in the future. It's

4 that it's not available right now.

5 And I guess that goes to the issue that

6 Commissioner Adler raised, that, you know, you are at

7 least given the flexibility to deal with it now, or

8 before the 100 parts per million limit goes into effect

9 in August.

10 And you're not restricted from coming back to

11 address the issue in the future, unless Congress

12 decides to act on the common Commission request to give

13 you more discretion.

14 CHAIRMAN TENENBAUM: Randy, do you have --

15 MR. BUTTURINI: Two other questions.

16 One is: When you're discussing perhaps having

17 exclusions based on metals, would it be useful to

18 consider having an exclusion based on an application of

19 a metal, where the lead is non-purposeful?

20 For example, a forging of let's say a pedal to

21 a bicycle? Typically, lead is needed for forging

22 applications. And would that be something that might

¶ Page 233

1 be a way to say there's certain ways that materials are

2 made or fabricated, or parts are fabricated, that would

3 be subject to one limit, and other ways, like machining

4 applications, that could be subject to other limits?

5 Or would that be practical or impractical?
6 MR. WOLDENBERG: I'd like to answer that

7 question with a question of my own:

8 What is the purpose of that type of exemption?

9 So if the purpose of the CPSC is to protect safety,

10 what is the purpose of that type of very fine

11 restriction on a particular kind of attachment, if it

12 has nothing whatsoever to do with safety?

13 So I personally would advocate for simple

14 rules that are not complex.

15 I've testified before that we are now subject

16 to 3,000 pages of rules. And so I'm really loathe to

17 encourage the CPSC to make this more complicated.

18 I can't teach it as it is. Three thousand

19 pages is like this much paper. I can't read it all. I

20 don't even know what it says.

21 I do the best that I can. I have people that

22 work for me that have to know this stuff. I mean,

¶ Page 234

1 we're a small business, and we have 150 people.

2 Imagine if you have ten. I mean, this is

3 completely beyond anyone's ability to deal with.

4 One of the reasons companies are dropping is

5 they can't manage all these rules.

6 So we can't default to taking sort of like a

7 goofed-up requirement and just making it super, super

8 complex, as a solution;

9 Because the complexity makes it not a

10 solution.

11 CHAIRMAN TENENBAUM: Okay. Randy? Or anyone

12 else want to answer that? John or? Okay, John you

13 want to answer that?

14 MR. BOGLER: Yeah. Randy, specific to what I

15 was talking about earlier, it was material-based. It

16 wasn't process-based.

17 We were looking at tubing. We were looking at

18 tubing, we were looking at forging. And we were

19 looking at rod material.

20 And the material right now is specifically

21 recycled steel. It's the material. It has nothing to

22 do with the machining process, per se.

¶ Page 235

1 There were other issues that we were

2 discussing about where the machining process is

3 important, and lead is added for the machining process.

4 But just in straight steel and recycled steel,

5 it's just the material. It has nothing to do with
6 process.

7 MR. BUTTURINI: But if you look at the

8 materials books on steel, there are many, many alloys

9 that have less than 100 parts per million.

10 And those alloys are good for certain

11 applications, and less desirable for other

12 applications.

13 So on a materials basis, you know, 4400 steel

14 versus 4404 steel is used for different sorts of

15 things.

16 And I was just asking a question: Would it be

17 useful to, say, on an applications basis -- it was a

18 leading question -- would it be useful in this regard?

19 And maybe it would be useful and maybe it would just be

20 excessively complicated to try to do something like

21 that.

22 MR. BOGLER: I think many people have

¶ Page 236

1 discussed it. There's different materials. And there

2 are materials that are available that have less than

3 100 parts per million;

4 But what the discussion that the bike industry

5 was talking was the feasibility and reasonability of

6 making product at a price-specific point.

7 There are materials out there that meet the

8 100 parts per million, but they're so expensive you

9 can't make a children's product out of them.

10 Carbon fiber, there are some high-end

11 aluminum. But we're talking about a steel bike at a

12 price point, you know, $29 to $129, $200 bikes.

13 MR. WOLDENBERG: But why is it your business

14 to tell us what material to use, if it's unrelated to

15 safety?

16 So it's all well and good that you guys can

17 figure out what steel we ought to use in our products;

18 but why should you be telling us?

19 This is our business. And I don't see how it

20 serves the safety interest for you guys to go out and

21 say, "Well, use this kind of steel for this, and this

22 kind of steel for that."

¶ Page 237

1 I mean, our business is complicated enough,

2 and this is our expertise. But I don't think that we

3 need the U.S. government for that service.

4 CHAIRMAN TENENBAUM: Okay. You had one more

5 question?
6 MR. BUTTURINI: I have one more question. It

7 was when Mr. Locker was talking plastics, look like

8 they can do well, achieving things below 100 parts per

9 million.

10 And non-homogeneous materials and metals can't

11 do these sorts of things. And alloys, we're having

12 trouble making measurements below 300 parts per

13 million.

14 And my question is: In going through this

15 analysis, did you consider a substitution, where there

16 are certain things that are using metals for now, that

17 perhaps something that could be substituted for it,

18 that is either exempt, like a stainless steel, or

19 another material, or a plastic that would be below the

20 100 parts per million, as fabricated?

21 Was that just part of the thing, or were you

22 were saying, "I have a metal, and I want to replace it

¶ Page 238

1 with another metal"?

2 MR. LOCKER: No. And as a matter of fact, in

3 a lot of our industries, the whole history of the

4 industry is a history of material de-selection and

5 substitution, to avoid hazards to begin with.

6 So we already start with the premise that that

7 is a preference, that if we could avoid using any

8 material, whether it's actually hazardous or not, but

9 legally listed that way, we avoid it.

10 For a variety of reasons. Just like, you

11 know, my colleague sitting to my left here chooses to

12 use stainless steel in her keys, where we can have

13 options, we do choose them.

14 But as to whether they're going to be

15 commercially viable and available, that's been the big

16 problem, particularly when we're talking about common

17 components, metallurgical products that we don't

18 fabricate ourselves.

19 Which is why we said we have better control

20 over plastics.

21 And you know, I remember being here three

22 years ago. We talked about the lead issue as primarily

¶ Page 239

1 a pigment issue. It was the same as the paint. If you

2 solve the pigment issue, you solve 90 percent of the

3 lead issue.

4 But we're getting to that other ten percent,

5 where it's becoming more problematic to solve, as you
6 drop down to the very low levels.

7 And as I said, and when you layer in the

8 variability, that also exacerbates it.

9 CHAIRMAN TENENBAUM: All right.

10 Well, we thank -- oh, Randy, do you want to?

11 MR. BUTTURINI: I'm all done.

12 CHAIRMAN TENENBAUM: Okay.

13 Thank you all for attending. Thank you for

14 your excellent presentations and the preparation it

15 took.

16 We'll be communicating with everyone about the

17 number of days we can leave the record open.

18 Oh, Ms. Chapman, you wanted to say one more

19 thing?

20 MS. CHAPMAN: There has just been a lot of

21 discussion recycled metals. And stainless steel,

22 according to the Stainless Steel Association, is 50

¶ Page 240

1 percent typically recycled.

2 So there are some exceptions to the alloy

3 rule. And -- sorry, I was pulling up an e-mail from a

4 metallurgist, who I know we have said it would be ideal

5 if there were a metallurgist here:

6 This is just in reference to stainless 304.

7 He says: "There should not be any problems with lead

8 in 304, since it is vaporized at stainless steel

9 melting temperatures, and shifted into the slag.

10 "Even if the lead somehow managed to make it

11 through the melting stage, the slab would exhibit

12 severe hot cracking during hot rolling, even at very

13 low concentrations. The lead content in stainless

14 steel is typically only a few parts per million and is

15 not harmful."

16 So just before we rule out recycled metal

17 completely, there is that option.

18 And then the other thing I wanted to add is:

19 I completely understand not wanting to make things too

20 complicated. When I got into this, I was daunted by

21 what are the rules and regulations; what do I need to

22 be doing?

¶ Page 241

1 And to the CPSC's credit, I have talked to

2 many people within your Commission, who have been

3 really helpful in answering questions for me, and

4 sending documents when I needed them.

5 So, thank you.
6 CHAIRMAN TENENBAUM: Well, thank you. We've

7 been following your company with interest. And we

8 appreciate your entrepreneurial spirit, and what you've

9 been able to accomplish.

10 But we were very aware before you came today

11 of your company.

12 MS. CHAPMAN: Well, thank you.

13 I have to also say that when I got the call, I

14 was just thankful that it was not for a recall already.

15 (Laughter.)

16 CHAIRMAN TENENBAUM: Thank you all for being

17 here, and for your great attention.

18 (Whereupon, at 3:20 p.m. the meeting was

19 adjourned.)

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