U.S. CONSUMER PRODUCT SAFETY COMMISSION

Staff Workshop On Potential Ways To Reduce 

Third Party Testing Costs Through Determinations 

Consistent With Assuring Compliance

AUDIO TRANSCRIPTION

Thursday, April 3, 2014

9:00 a.m.

National Product Testing 

and Evaluation Center

5 Research Place

Room 103-105

Rockville, Maryland 20850

Diversified Reporting Services, Inc.

(202) 467-9200
2

STAFF: 

Jacqueline Campbell, Division of Flammability and 

Combustion, Directorate for Engineering

Sciences, CPSC, Moderator

Randy Butturini, Office of Hazard Identification and 

Reduction, CPSC

Joel Recht, Ph.D., Director, Chemistry Division, Directorate 

for Laboratory Sciences, CPSC

Kristina Hatlelid, Ph.D., M.P.H., Division of Toxicology and 

Risk Assessment, Directorate for Health Sciences, CPSC

Rick Uhl, Chemistry Division, Directorate for Laboratory 

Sciences, CPSC

Patricia Adair, Directorate for Engineering Sciences, CPSC

Neal Cohen, CPSC, Small Business Ombudsman

Michael Babich, Ph.D., Director, Division of Toxicology and 

Risk Assessment, Directorate for Health Sciences, CPSC

John G. Mullan, Special Assistant, Office of Commissioner 

Buerkle, CPSC

PANELISTS:

David Owen, BASF

Sanjeev Gandhi, Ph.D., SGS Consumer Testing Services

Al Kaufman, Toy Industry Association

Sheila Millar, Keller and Heckman, LLP

Kyra Mumbauer, Society of the Plastics Industry

Nikki Brown, Ph.D., Penn State University

Bill Perdue, American Home Furnishings Alliance

Mark Fellin, Juvenile Products Manufacturers Association

Hailey Mann, American Plastic Toys

Ami Gadhia, Consumers Union
3

PANELISTS (Con't):

Randall Hertzler, Handmade Toy Alliance

Rebecca Mond, Toy Industry Association

Rachel Weintraub, Consumer Federation of America

OTHER PARTICIPANTS:

Chris Leonard, Modern Testing Services 
4

C O N T E N T S

PAGE NO.

 I. INTRODUCTORY REMARKS, Jacqueline Campbell 5

II. INTRODUCTION: Randy Butturini 6

III. PHTHALATES, Jacqueline Campbell, Moderator

Staff Presentation: Joel Recht, Ph.D. 13

Panelists 17

Dave Owen 18

Sanjeev Gandhi, Ph.D. 22

Al Kaufman 30

Sheila Millar 40

Kyra Mumbauer 46

Discussion 53

AFTERNOON SESSION 98

IV. LEAD AND ASTM 8 ELEMENTS, Patricia Adair, Moderator 98

 Staff Presentation: Kristina Hatlelid, Ph.D., M.P.H. 99

Panelists

Nikki Brown, Ph.D. 103

Bill Perdue 110

Mark Fellin 118

Al Kaufman 122

Hailey Mann 129

Sanjeev Gandhi, Ph.D. 133

Discussion 135

V. DISCUSSION, Neal Cohen, Moderator 176

Panelists: 

Ami Gadhia 178

Randall Hertzler 182

Rebecca Mond 184

Rachel Weintraub 186

VI. CLOSING REMARKS, Jacqueline Campbell 209
5

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

2 I. INTRODUCTORY REMARKS

3 MS. CAMPBELL: Can everyone hear me? I guess I 

4 should ask that first. Yes? In the back we're good? Okay. 

5 Terrific. My name is Jacqueline Campbell and I want to 

6 welcome all of you here today to participate in the 

7 discussion about burden reduction from third-party testing, 

8 based on material determinations. And I just wanted to go 

9 through a couple of housekeeping things. I know you guys 

10 have gotten a lot of e-mails from me, recently. So you know 

11 who I am here.

12 So, quickly, before we get started, I want to let 

13 you know where the restrooms are. For those of you who 

14 haven't been to our facility here, if you go straight 

15 through the double doors to my left, the restrooms are 

16 there. You don't have to badge through. It's accessible. 

17 Also, in the case of emergency, we just want to -- we're 

18 safety here. We want to make sure you understand what to 

19 do. CPSC staff will give you instruction on how to leave 

20 the building and where to meet up. 

21 Just a real quick reminder about cell phones. If 

22 you could go ahead and silence your cell phone, that would 
6

1 be fantastic. Again, we're webcasting, and it would be 

2 distracting. Also, we recognize that the room is very open 

3 here. If you need to take a call or have a conversation, 

4 there is a small lobby through these double doors next to 

5 the restroom; but, additionally, you could go through by the 

6 guard's desk and either go outside, or you could be in the 

7 lobby. 

8 So that is available to you. Another quick note: 

9 We do have wireless available if you want to connect to it. 

10 It's a public wireless access. There's no password that's 

11 required. So it may be a little slow, but it is there. 

12 With that, I think I'm going to ask our first panelists to 

13 come up to the table and we'll get started in just a moment. 

14 So our first panel is for the phthalates panel, if you could 

15 come up. We have a place for you there. Thank you.

16 Thank you panelists, and with that I'm going to 

17 hand over to Randy Butturini, who's going to be presenting 

18 the staff presentation. Thank you, Randy.

19 [Slide presentation.]

20 II. INTRODUCTION

21 MR. BUTTURINI: Thank you, Jacqueline. Welcome, 

22 everyone. I'm Randy Butturini from the Office of Hazard 
7

1 Identification and Reduction, and I am going to get to why 

2 everyone has to pronounce her name in just a moment. But I 

3 do want to welcome you myself here to our workshop on 

4 potential ways to reduce third-party testing burdens. 

5 On the previous slide we have the disclaimer at 

6 the bottom, and we like that disclaimer so much that we 

7 repeated that disclaimer on the second slide. But there are 

8 two other statements to make. One is that, of course, 

9 presentations by people who are non-members of CPSC staff 

10 don't necessarily represent the views of the government or 

11 the staff. That seems pretty obvious. And because this 

12 workshop has been webcast and recorded, that's why we want 

13 when everyone speaks, we want you to say who you are so that 

14 the recording of this and the people on the web can 

15 understand it. There's of course no way they could read 

16 your badge from this far away. 

17 Here's the agenda we'll follow. It's the same as 

18 the agenda you have, "Introductory remarks followed by 

19 purpose and goals," then a session on phthalates that will 

20 take up the rest of the morning. The way this will work is 

21 that we will have a set of presentations by CPSC staff and 

22 by the panelists that are up here; and after that, there 
8

1 will be this question and answer period to get further 

2 information or to sharpen the focus on items and things like 

3 that. 

4 When people are speaking, for these microphones, 

5 there are only four of them that can be on at the time. 

6 That's the technology we have. So if you're speaking into a 

7 microphone and a little red light is on after you press the 

8 button, once you're done, you press the button again. So 

9 you want to do that to allow the other speakers to come in 

10 and do those sorts of things; and that's mostly for the 

11 panelists and us here. 

12 Lunch break followed by the other two sessions 

13 that we'll have, "Lead and ASTM 8 Elements," discussion on 

14 burden reduction through determinations, and then closing 

15 remarks that we may need to make. The purpose of this is,

16 as explained in our operating plan, we want to conduct 

17 additional research, additional research that scientifically 

18 defensible, that provides the widest scope of relief, 

19 benefits the most people the most ways, of course without 

20 affecting compliance. 

21 And what's the purpose of this research, this 

22 research we want to have to point towards possible 
9

1 rulemaking on determinations, to make a list we have larger, 

2 to create a new list, to do something else. That's what 

3 we're looking to do. That's what the CPSC staff is hoping 

4 to learn from people. There's information that can lead to 

5 potential rulemaking. 

6 The scope of this is limited to burden reduction 

7 through determinations, not even burden reduction through 

8 other means will be discussed here, because we want to focus 

9 on the determinations part of this. So questions about 

10 certification, questions about test methods, questions about 

11 content limits, definitions and other things will just be 

12 out of scope. They are interesting things, but they're not 

13 interesting today in this particular venue. 

14 A little history for those who may be new to the 

15 field, the Consumer Product Safety Act, the Improvement Act 

16 of 2008 established contents on lead and concentration 

17 limits for 6 phthalates in children's toys and childcare 

18 articles, and also established wherever the current version 

19 of ASTMF 963 -- right now it's version 11 -- and it has a 

20 limit of soluble amounts of the 8 elements that you can see 

21 there. Of course, compliance testing is required by Section 

22 14(a) to the CPSIA, and that's where some of the burden 
10

1 comes in: Third-party testing for compliance to appropriate 

2 safety rules. 

3 However, Public Law came out, P.L. 112-28 came out 

4 and said is there a way that you can reduce the burden? And 

5 we have a couple of magic words that we're using here, and 

6 one of the magic words are consistent with assuring 

7 compliance. Can we reduce the burden consistent with 

8 assuring compliance with applicable rules? So the burden 

9 reduction is in regards to compliance that we're dealing 

10 with here. That's partly why we're here. What we've done 

11 in the past in the Commission is had a request for comments 

12 on the field, gotten those back and turned those around, 

13 followed up by a request for information regarding a third14 party testing of these items. 

15 That's what the Commission wanted to focus on 

16 first in the sort of recommendations that were made. So 

17 that's why we're having this workshop. There's the Federal

18 Register Notice, the docket number, CPSC 2011-0081, and 

19 there are two more weeks available for written comments. So 

20 if you come up with an idea, there's something you think 

21 about the next couple of days, you have the perfect 

22 response. There's your opportunity to go to the 
11

1 regulations.gov and submit a written comment. The goals of 

2 this are we're looking for evidence and information about 

3 the way that certain materials can comply with a high degree 

4 of assurance5 there's another magic word- irrespective of their 

6 manufacturing, and without requiring third-party testing. 

7 That would be the burden reduction part of this. “How” is 

8 another magic word. How can the Commission get around to 

9 making a determination that material X or Y doesn't require 

10 third-party testing? Yet, we still have a high degree of 

11 assurance that it will all be compliant. That's not an easy 

12 thing to do, because we want to have it be compliant now, 

13 and we want to have it be compliant in the future if we're 

14 not having third-party testing.

15 Those are some of the challenges that we're facing 

16 with determination. We are also looking for another magic 

17 word, a high degree of assurance of compliance with the 

18 applicable safety rules. What sort of things are we 

19 thinking about when we are talking about a high degree of 

20 assurance? Where does the raw material come from? How is 

21 that raw material turned into a component part or a finished 

22 product? What happens if you introduce recycled materials? 
12

1 This is especially true among plastics of certain types. 

2 What happens there with a high degree of assurance of 

3 compliance, and then what's the potential for contamination 

4 after a component part or a product has been made? If there 

5 is a high degree of potential for contamination, that might 

6 get in the way of coming up with the determination. 

7 Those are some of the factors. You know. Where 

8 can things go wrong is one way to put this. And how can we 

9 show that things have gone right so that we can make a 

10 determination with a high degree of assurance? And there's 

11 the other magic word, again. How can we show that things 

12 are going right? The topics here for this will be limited 

13 to the three areas that we mentioned in the Federal Register

14 Notice: Phthalate content, lead content, and the solubility 

15 of the 8 elements in the toy standard; but, I like the 

16 pictures, because conceivably underneath the little train, 

17 there is actually some of the 8 elements leaking out 

18 already. So that's why we chose that picture. 

19 And, with that, we can move over to the beginning 

20 of the discussion on the phthalates, and I'll ask Jacqueline 

21 to come back up and moderate this. 

22 MS. CAMPBELL: And I will immediately hand this 
13

1 over to Dr. Joel Recht, who will be giving the staff 

2 presentation on phthalates. Thank you, Joel.

3 [Slide presentation.]

4 III. PHTHALATES

5 DR. RECHT: Thank you, Jacqueline, and thank you, 

6 Randy. And thanks everybody for coming. Good morning. I 

7 am Joel Recht. I'm the Chemistry Division Director here at 

8 the CPSC. I promise, despite being a chemist, I will not 

9 give a chemistry quiz or ask anyone to draw a diagram like 

10 that of a Phthalate molecule.

11 The reason we're here, as Randy was saying, is to 

12 look for evidence to support a possible determination of how 

13 we could identify materials that do not and will not contain 

14 prohibited phthalates in concentrations above 0.1 percent. 

15 We are asking, “what data should we consider to decide 

16 whether to recommend the determination?” And, how can we be 

17 assured that a material, regardless of where it's made, 

18 regardless of the manufacturing process -- the potential for 

19 contamination or any other factor -- would continue in the 

20 future to comply with the phthalates limit as it continues 

21 to be produced, and not just produced by the highest quality 

22 manufacturers for the highest quality products, but also for 
14

1 the lower quality, lower price, lower value products as 

2 well?

3 What kind of follow-up activities should be 

4 required to assure continued compliance of a material? What 

5 other technical, practical or implementation issues should 

6 we consider before possibly recommending phthalates 

7 determinations? And as Randy pointed out, also, what 

8 materials would provide the greatest cost savings if we made 

9 the determination, and why is that?

10 Back in 2009, the Commission issued a statement of 

11 policy of materials that may contain phthalates. It's a big 

12 list of different materials, things like PVC, polyurethane 

13 adhesives. You can see them all there, and there's a link 

14 to the full text of the actual statement of policy. So if 

15 you want to follow-up and read that, that's the reference. 

16 As far as materials that may contain phthalates, we actually 

17 still would like to know more. 

18 What materials should always require third-party 

19 testing, and not have a determination, because they might 

20 have phthalates above a tenth of a percent? And, why? What 

21 evidence, what information would tell us that? What 

22 specific data or other information is sufficient for us to 
15

1 say this is a material that might contain phthalates and 

2 should not have a determination, should require third-party 

3 testing? 

4 About two years ago we held a phthalate symposium 

5 right here in this room, more on testing; but, at that 

6 symposium, Bob Alcorn of Intertek presented this slide. I 

7 think it's an interesting slide. I think it's illustrative 

8 of some of the complexity of considering determinations for 

9 certain materials. And what we have here, if you look, 

10 different bars -- and it's difficult to see with the blue on 

11 blue on our screen; but, for instance, for poly-oxy12 methylene, POM, there's a line here showing 33 percent. 

13 Let me first describe the bars. We've got 

14 different materials: glue, polyurethane, plastic, rubber, 

15 hard plastic. These are what the submitters of the samples 

16 declared the samples to be to the test lab. So it's not 

17 necessarily what they were, but a firm sent something to, in 

18 this case, Intertek, and said this is hard plastic. Please 

19 test it for phthalates, or any of those other categories. 

20 And the complexity is that in each of these cases, we're at 

21 two percent here on hard plastic, so six percent on rubber. 

22 There were some phthalates present or there were phthalates 
16

1 present as what Intertek describes as failing rates in all 

2 of these materials, these types of materials. 

3 Complexities aside, though, we are interested in 

4 conforming plastics. What materials are there that are used 

5 and could be used that result in plastics that always meet 

6 these requirements, that always conform to the phthalates 

7 limits? We also need information and evidence about the 

8 possibility that those materials might end up containing or 

9 being exposed to prohibited phthalates. 

10 Information such as the potential use of recycled 

11 content in these plastics, or some other way phthalates may 

12 be included at non-compliant levels, maybe through the 

13 addition of colorants or other additives. We are looking 

14 for information about the possibility or likelihood of 

15 contamination of component parts or finished products with 

16 prohibited phthalates. What we want to know is “how and why 

17 can we be assured the continued manufacture -- again, 

18 regardless of where it's made -- would continue to be 

19 compliant with the phthalates limit?” 

20 How can the Commission address potential new 

21 applications or new methods of production of plastics? 

22 Maybe we find a plastic that never has phthalates in it, 
17

1 because you just can't put them in? There's no good way to 

2 put it in and make that plastic. What happens if some 

3 intrepid chemist, some guy like me, comes up with a way to 

4 get the phthalates in there? How can we address that in the 

5 future? What other technical, practical or implementation 

6 issues should CPSC consider before making recommendations 

7 regarding phthalates determinations? And, what would be the 

8 potential cost savings? What burdens would we reduce if we 

9 were to recommend and adopt a determination, especially 

10 considering that it still requires that you comply with the 

11 underlying standards? 

12 We are now going to move on to our presentations. 

13 Our panelists will each give a presentation. We'll wait 

14 until after they complete their presentations, and then 

15 we'll open it up for questions and comments from CPSC staff, 

16 as well as the public that's here in the room. 

17 Unfortunately, we will not be able to accommodate questions 

18 from our web-casting public, but again, if you have 

19 comments, the docket is open, as Randy pointed out earlier.

20 So, with that, I am pleased to introduce Dave Owen

21 from BASF, Sanjeev Gandhi from SGS, Alan Kaufman from the 

22 Toy Industry Association, Sheila Millar from Keller and 
18

1 Heckman, and Kyra Mumbauer from the Society of the Plastics 

2 Industry. And, Dave, you're up first. So let me bring your 

3 presentation up. 

4 PANEL: Slide presentations.

5 MR. OWEN: Well thank you for inviting me. I am 

6 the antithesis of what you're looking for, but it's a good 

7 place to start so that we understand where plasticizers go. 

8 Now I'm going to go through the first part rather quickly, 

9 because it just talks about the wall, which we're all 

10 familiar with. You are the 6 phthalates, the prohibitions.

11 What I did want to start with, and this goes back 

12 to the first reading we had, was people that aren't in the 

13 vinyl business are not familiar with phthalates, and don't 

14 know that these are FDA approved products for food contact. 

15 They go into closures or have gone into closures, which are 

16 like the tops on beer bottles, et cetera, the tops on peanut 

17 butter jars, wrapped like vegetable wrap, and more 

18 importantly they're used in medical applications. 

19 I might stick my neck out, but I think 95 to 99 

20 percent of the blood in the United States is contained in 

21 vinyl blood bags plasticized with BOP. Blood bags last 

22 longer than glass and, of course, they don't break. Now, 
19

1 how do you make a phthalate? You react phthalate anhydride 

2 with an alcohol. The alcohol on the top is called the 

3 linear or normal alcohol; the one on the bottom is called a 

4 branched or isoalcohol. 

5 So you have a reaction, and the one on the bottom 

6 is Di(2-ethylhexyl) phthalate (DEHP). These are gas 

7 chromatograms of the different phthalates. You can see that 

8 four are just one chemical, and two have a whole bunch of 

9 isomers. They look like a probability distribution. For 

10 the BOP, Di butyl phthalate, butyl benzyl and the normal 

11 actol, our minimum level of detection is about 50 parts per 

12 million. When you get to the isomers, you go up to 250 

13 parts per million, because you have so many different 

14 isomers that it's difficult to quantitate. 

15 All right. These are chemicals, so you have 

16 physical properties, density, viscosity, 4 point flashpoint 

17 for density. They're all around one gram per milliliter, 

18 viscosity fairly low, less than 100 centipoise. Core point 

19 is minus 40. They're very flowable. So even in your rough 

20 winter they have a very high flash point, and the vapor 

21 pressure is very low. Six millibars at 200 degrees C means 

22 that if you put a drop on the table and come back 20 years 
20

1 later, they'll still be there. 

2 All right. What are the uses? They're used as 

3 plasticizers. They can be used as diluents, and they can 

4 also be used as lubricants. These are the polymers with 

5 which I have experience, and of course I'm most experienced 

6 with PVC and phthalates. Anything else on that list I would 

7 defer to somebody more involved in the business. Rubber is 

8 mainly for wire and cable. Acrylics is for basically 

9 coatings as well as nitro cellulose lacquer. Urethane is 

10 both a thermal plastic polyvinyl acetate for adhesives, and 

11 the polyvinyl butyral.

12 Now, for the acrylics, I am told that the acrylics 

13 that go into toys do not contain phthalate. So, you know, I 

14 defer to that. Typically, you don't find plasticizers in 

15 these applications. Olefins like polyethylene, the 

16 styrenics, the nylon and rigid PVC. Why? Olefins are 

17 materials that are crystalline. So the phthalates are not 

18 compatible. In other words, they'll ooze out and you don't 

19 have a saleable product. Styrenics, you can get stress 

20 cracking with exposure to phthalates. Nylon, they can use 

21 something else, and rigid PVC you can have anti22 plasticization, which means your plastic will get stiffer 
21

1 and more brittle with a little bit of plasticizer in there. 

2 All right. There is a theory, which I'm not going 

3 to go into, but it's based on Gibbs free energy with 

4 enthalpy and entropy. And what we usually do is calculate a 

5 solubility parameter of the polymer, compare that to the 

6 solubility parameter of the plasticizer, and then if they’re 

7 close you usually have solubility. Something like nylon has 

8 a solubility parameter 15. The phthalates are about 8. So 

9 they're not really soluble in nylon. 

10 If you want to go and find more information, you 

11 can go to The Technology of Plasticizers by Sears and Darby. 

12 And for looking at specific polymers, The Handbook Of 

13 Plasticizers by Wypych is a great resource. I'd like to 

14 thank my colleagues, my ASPM task group members. And when I 

15 sent this to the lawyers for approval, just like your 

16 disclaimer, the only thing they said is I have to make it 

17 bold and capitalize it. So there's our disclaimer. 

18 Thank you very much.

19 [Applause.]

20 MS. CAMPBELL: Just real quickly, I would like to 

21 announce that we will be putting all of these presentations 

22 up on SlideShare after the workshop, probably sometime next 
22

1 week. And, with that, I'll hand it over to Sanjeev Gandhi. 

2 Thank you.

3 [Slide presentation.]

4 DR. GANDHI: Hi. I'm Sanjeev Gandhi. I'm Deputy 

5 VP and Technical Director for SGS. I would like to thank 

6 the Commission for this invite to be here and share some 

7 perspective from a testing lab point of view. I would like 

8 to talk about the question of phthalates in this session. I 

9 know that the theme of this workshop for the whole day's 

10 session is also about lead and soluble heavy metals.

11 Randy did a good job of laying out what's the 

12 goals of the workshop are, so I am not going to repeat this 

13 slide. I just want to make a point about what are the 

14 considerations that we are looking at as a collective set of 

15 stakeholders. Here for the goal of reducing third-party 

16 testing burden is looking at the intrinsic material 

17 properties to make the determination of what could be 

18 considered as a positively stuff plastics or other 

19 materials, looking at the manufacturing processes, knowing 

20 the inherent characteristics of those materials -- let's say 

21 resin stage -- and any further downstream processing and 

22 use. And I should also say downstream abuse of those-what 
23

1 started out as a pure polymer, and when it's built into a 

2 molded plastic form and what goes into there. 

3 That's where the real world starts to get 

4 materials and toys and other types of plastics products. So 

5 we need to look at the whole supply chain characteristics 

6 and what happens from when we come over some kind of 

7 considerations that could be considered for making some 

8 policies decisions on behalf of the CPSC. So the goal is 

9 not to compromise the compliance, and it should provide 

10 tangible savings in terms of the testing cost. 

11 So, Randy and Joel, you had a list of all the 

12 suspect list of materials that already exist in the statute: 

13 vinyl and vinyl-like soft materials, and some of these 

14 considered as suspect materials for having phthalates. So 

15 the goal is to create a positive list for exempt plastics 

16 and other types of materials. And so it started by looking 

17 at some data on different types of plastics. You know, this 

18 is on the left-hand side. Pull up some basic commodity 

19 plastics that I used in a consumer applications. 

20 So this is the data from one of the other reports, 

21 and these are the reports that came out: About 230 million 

22 tons of plastic that are produced in this consumer 
24

1 application space, and what is the distribution of those 

2 plastics. And, you know, I should point out these are for 

3 all types of different consumer applications, not 

4 necessarily for toys or children's articles alone. And, 

5 however, the ones with a check mark in the front are also 

6 used for toys based on our experience, and the distribution 

7 may look different from some other data, which may be a 

8 little bit more granular. 

9 One of my colleagues pointed out the PVC may not 

10 be as high as 70 percent in real life with the type of 

11 product that we see in the toy world. And, that may be 

12 true, because there are a lot of vinyl shower curtains out 

13 there, so because this data covers all kinds of consumer 

14 applications. So if you start to look down on the other 

15 plastics that are not commonly used and could also be looked 

16 at for a positive type of exemption -- POM, PBT, 

17 polycarbonate -- knowing the chemistry of these polymers, as 

18 David also pointed out are alluded to, some of these are not 

19 likely to have any kind of phthalates. And, so they could 

20 be considered, based on the anecdotal data also -- specific 

21 industry data that they could be exempt -- could be deemed 

22 exempt or considered for that. 
25

1 So the point I wanted to make here, looking at 

2 side by side is a lot of these plastics are not used for 

3 common consumer applications. They are either engineering 

4 plastics and other types of applications. So would that 

5 provide any kind of tangible cost-saving by itself, having 

6 this list of plastics on that exempt list? So I just wanted 

7 to point that out. They qualify based on one criteria, but 

8 whether the result is tangible or not in terms of cost 

9 saving, that's something to be examined. 

10 We also wanted to look at some empirical data that 

11 we were able to pull together from our lab overseas, and 

12 this is a very high level data. Unfortunately, I don't have 

13 the granular data. I do recall the slide that Joel put up 

14 there from Intertek from two years ago. So we have the same 

15 challenge now of the granularity of the data because of the 

16 way we get the material declarations as part of the product 

17 description is not detailed enough for us to break it down 

18 into different types of polymers in the area of plastics. 

19 So out of this 10,000 plus data points across 

20 different types of the substrates that are tested, I should 

21 say 60 to 70 percent of those are relating to the 

22 highlighted sections on plastics and rubbers, and rubber is 
26

1 very generically used on here. It includes all kinds of 

2 soft materials, however, not the PVC. So looking at those 

3 two categories alone, it kind of jives with the data that at 

4 a very high molecular level that was shown by Intertek two 

5 years ago, a very high rate of, let's say, compliance rate. 

6 However, we do see -- if I show the second chart 

7 here -- depiction of this thing. This is showing the 

8 failure rate, which is, you know, in many of these cases 

9 less than one percent across different types of plasticizers 

10 and material types. What we see is a lot of positives that 

11 are detectable. Basically, they are detectable, but they 

12 are below the failure limit. 

13 So if I add all of those different types of 

14 positive detect samples, you know, I am looking at a very 

15 high level, high compliance rate of 95 percent. However, 

16 thousand data points across those 10,000 total data points, 

17 where the data falls in between the fail and the positive 

18 detection space, so they are detected, but they are below 

19 the thousand PPM threshold limit. Which, again, what does 

20 that mean? You know. This could mean something to do with 

21 possible contamination in the process line that has 

22 transferred over into the materials that are coming to our 
27

1 lab, and could also be something to do with the polymers 

2 mixing that is taking place at some stage. 

3 However, since they are less than one percent, 

4 1,000 PPMs, less than .1 percent, so mixing is not a likely 

5 scenario. It is mostly the contamination that is a likely 

6 scenario that may be attributed to this high number of 

7 positive samples. So the data, the physical data I have 

8 determined, that based on our experience is really don't 

9 tell us what kind of polymers can be deemed exempt based on 

10 the material as fair rates. 

11 Now, so, what are the other practical and 

12 technical considerations that can be looked at? Practical 

13 consideration, you know, we have a practice of accepting 

14 bill of materials. And as for other regulatory streams that 

15 flows from upstream supplier in the form of some guaranty 

16 letter, it goes all the way up to the final formulator of 

17 the product. That could be something looked at; but, again, 

18 that is based on without any validation built into that 

19 process. And what particular companies who are vertical in 

20 their operation -- you know -- they have the down-stream, 

21 upstream control in their supply chain to exercise that. 

22 And that bill of materials can carry a lot of weight, and it 
28

1 should be. But would that apply uniformly to all the 

2 different types of formulators out there? 

3 That's something needs to be explored. Then, if 

4 you had to look at from another angle, any technical 

5 considerations that again go back to the material, intrinsic 

6 properties we talked about in previous discussions at other 

7 forums about Shore hardness being one of the surrogate 

8 properties that can be used as an indicator of the hardness, 

9 and therefore the presence of plasticizer in some content, 

10 as some content. 

11 However, there are potential issues with that, 

12 especially in case of styrenics. You know, there are 

13 materials that could be considered rigid based on Shore 

14 hardness, but I think the threshold used or talked about in 

15 the industry circles is 90. So it could be rigid, but it 

16 could still have about one percent plasticizer in those 

17 styrenics, then glass or some other form, but I shouldn't 

18 say particularly styrenics.

19 Then I was looking at some of the research while 

20 preparing for this meeting. You know. Glass solution 

21 temperature is a really intrinsic material property, and 

22 that's a very particular polymer chemistry tone, which 
29

1 speaks to the transition of the material when it changes 

2 from a glassy state to a rubbery state. And it has to do 

3 with moment that the polymer changed, and that's what some 

4 of the plasticizers facilitate by giving their pliability 

5 characteristic to the material. And if you look at this on 

6 the right, which is taken from one of those plasticizers 

7 that David had up as a citation in his presentation just a 

8 minute ago, based on that data, the linear relationship with 

9 how the TG changes with the rear fraction of the plus side 

10 of those. 

11 So that's a material characteristic, physical 

12 property, that should be looked at. And I've done some 

13 limited, scientific research on that. I haven't really come 

14 up with a whole lot. I do know down the road here has a 

15 thermo mechanical properties database that needs to be 

16 looked at in more detail. And we should talk to them to get 

17 some more information about the importance of this glass 

18 that isn't transitioned and pictured as a characteristic 

19 that can be looked at as a surrogate and a proxy indicator 

20 of content of phthalates in plastic. 

21 So leaving that as a food for thought and for the 

22 discussion, I'll wrap up. Thank you.
30

1 [Applause.]

2 MS. CAMPBELL: I'd like to introduce Al Kaufman 

3 from TIA who will follow-up. Thanks.

4 MR. KAUFMAN: Thanks, Jacqueline.

5 [Slide presentation.]

6 MR. KAUFMAN: Good morning, everyone. I'm Al 

7 Kaufman. I'm the Senior Vice President of Technical Affairs 

8 with the Toy Industry Association. And, first of all, I'd 

9 like to thank the Commission and the staff for giving us 

10 this opportunity. We think this is a topic of great 

11 interest in industry, and we are thankful for the 

12 opportunity to speak on it today. 

13 First of all, very quickly, a little bit about the 

14 Toy Industry Association. We are the trade association for 

15 North American based manufacturers and porters, licensors 

16 and retailers of toys and other allied products. We also 

17 have associate members who are inventors, designers, test 

18 laboratories and other service providers to the industry. 

19 We were formed in 1916, so we are coming up on a hundred 

20 years, and we have a long history of dedication to child 

21 safety, going as far back as the 1930s. 

22 We have over 750 members who are involved in some 
31

1 way in producing and delivering toys to America's children, 

2 and our members represent about 85 percent of the U.S. toy 

3 market in terms of sales volume. You'll recognize some of 

4 our members, I'm sure. And just a real quick snapshot of 

5 the U.S. industry. The average price of a toy is less than 

6 $9, so clearly cost of what we believe to be a necessary 

7 testing is a big issue for a lot of our members. 

8 There are an estimated 3 billion units sold every 

9 year, about 22 billion in direct toy sales, and about 

10 500,000 -- a little over a half a million FTE jobs in the 

11 toy industry. And our total economic impact is about 69 

12 billion every year. And, at the outset, I want to make 

13 clear here that industry isn't seeking relief from having to 

14 comply. What we are seeking relief from is testing, which 

15 doesn't advance safety. 

16 We believe that we are still dealing with some of 

17 the unintended consequences of CPSIA and one of those 

18 consequences is the fact that there is some testing that is 

19 required that isn't telling us something, that anything that 

20 we don't already know. And so that's what we are here to 

21 talk about today.

22 First of all, we've provided information to CPSC 
32

1 on a number of other occasions previously, but we're going 

2 to present some proposals today, and we are also going to 

3 present some additional data. So one of the proposals is to 

4 revise the definition of accessible. I'm not going to spend 

5 a lot of time on this, because after I wrote this 

6 presentation, I had a conversation with the staff and 

7 realized that was out of scope for this workshop. So I am 

8 going to blow through that very quickly. 

9 Proposal 1: "To screen materials based on their 

10 rigidity, and then a proposal to test and exclude materials 

11 based on their specific composition." And we have 

12 rationales for that based on process knowledge and process 

13 controls that are in place, evidence from review of material 

14 and material producer supplied bills of substance, and then 

15 also evidence based on absence of in-testing carried out by 

16 our members. 

17 Well, first of all, definition of accessible, very 

18 quickly -- that I won't spend much time on this as I said --

19 the current definition of accessibility for phthalates is 

20 based on 16 C.F.R. 1500.48 and 49, which was originally 

21 developed for sharp edges and sharp points. So it's based 

22 on whether you can touch something. And since the issue for 
33

1 phthalates is oral exposure, by and large, we don't believe 

2 that anything you can touch necessarily presents a risk of 

3 exposure. And so, therefore, we're asking the Commission 

4 staff to look at that as a potential means of providing some 

5 relief. 

6 Proposal 2: "Utilize rigidity as an initial means 

7 of screening materials for exclusion from phthalates 

8 testing." Phthalates -- they're added to materials for 

9 plasticization, primarily, within the toy industry. It's to 

10 make them flexible. So rigid materials typically do not 

11 contain phthalates at appreciable levels. And, Shore 

12 hardness, we think -- I've got a little disagreement with 

13 Sanjeev here, but we think Shore hardness is an excellent 

14 proxy for rigidity. It can eliminate -- it can define 

15 materials which should not contain phthalates. 

16 On the other hand, there are some materials which 

17 do not -- would not be considered rigid by a test of 90 

18 Shore A that are also not going to be containing phthalates. 

19 So we'll talk about that in a minute. On the other hand, we 

20 are very open to having conversations with the staff about 

21 other tests for rigidity. In other words, Sanjeev mentioned 

22 glass transition temperature, flexural modulus comes to mind 
34

1 as well as a potential proxy. So we're certainly open to 

2 those conversations. 

3 What we are looking for is a very quick and easy 

4 test that would eliminate the reason or the requirement to 

5 test for phthalates, which is an expensive and slow test. 

6 Even some flexible materials don't require routine testing, 

7 and the materials that are listed -- and we'll get to a list 

8 of candidate materials in a moment -- utilize petroleum or 

9 natural gas as their feed stocks. They don't contain 

10 regulated phthalates, so it isn't in there from the start. 

11 For instance, we talked about PLA. 

12 Sanjeev mentioned it briefly. It's produced with 

13 cornstarch. Again, you're not going to see the restricted 

14 phthalates in those materials or in the raw feed stocks. 

15 The resin producers tightly control how much extraneous 

16 material gets in there, because these materials are 

17 polymerized in reactors at very high temperature and 

18 pressure in the presence of a catalyst. And so if you have 

19 extraneous materials in there that you don't know about, you 

20 risk that explosion. And so they're very, very careful 

21 about controlling what goes into these materials.

22 Polyolefins, polyethylene, polypropylene, et 
35

1 cetera, as Dave mentioned, they're simply not compatible. 

2 Phthalates are not miscible with the polyolefins, and you 

3 would know right away if there was some contamination that 

4 occurred. In many cases the people who are producing and 

5 molding polyethylenes and polypropylenes do not have 

6 phthalates in their plant, and so there is no opportunity 

7 for contamination. It's nowhere in the facility and there's 

8 no reason for it to get in there, even accidentally.

9 In the case of the thermoplastic polyesters, 

10 they're flexible, but they don't contain phthalates. The 

11 styrenics don't utilize plasticizers to attain their 

12 physical properties. In other words, typically what will 

13 occur is to get greater impact resistance in a styrenic 

14 material, it's usually either blended or copolymerized with 

15 1,3-Butadiene. That's synthetic rubber. And so the amount 

16 of rubber that's in there determines its physical 

17 properties, not the amount of plasticizer. 

18 And then some materials are plasticized, for 

19 instance, nylon 11 and 12, and cellulosics, but they're not 

20 plasticized with the regulated phthalates. And in many 

21 cases, I think, resin manufacturers, from what I've heard, 

22 have sort of moved away from phthalates in general as a 
36

1 plasticizer for these materials. 

2 Proposal 3, "Exclusions based on composition." 

3 And we think there are some materials that we probably are 

4 always going to have to test, for instance, polyvinyl 

5 chloride, with the exclusion of the rigid grades that I 

6 already mentioned. And I'll present some data in a moment 

7 that indicates that that by and large is where we are 

8 finding the restricted phthalates and other phthalates. 

9 Thermoset polyurethanes, you'll sometimes see this as a 

10 coating on something that looks like vinyl or pleather. 

11 That's very often plasticized with phthalates. 

12 Polyvinylidene chloride sometimes goes under the 

13 trade name saran, and we believe that that is potentially 

14 plasticized with the restricted phthalates. And so we don't 

15 see that being excluded, and the same thing for chlorinated 

16 PVC. And, again, for all of these, if you have a rigid 

17 grade, we believe that there's got to be some proxy that we 

18 can come to that would indicate that those materials are 

19 extremely unlikely to contain the restricted phthalates. So 

20 these are all potentially plasticized with the restricted 

21 ortho-phthalates. 

22 So this is a list of materials that we believe should 
37

1 be candidates for exclusion based on their composition, 

2 simply because phthalates are not typically utilized in 

3 rendering them flexible. And there are not opportunities, 

4 typically, for some sort of contamination to occur. We'll 

5 keep going here. And, by the way, to answer one of the 

6 questions that's in the FR notice, the materials, at least 

7 for the toy industry that would provide the greatest relief, 

8 would be the polyolefins and the styrenics. So ABS, high 

9 impact polystyrene, polypropylene and polyethylene, if we 

10 can get some sort of categorical material exclusion for 

11 those materials, those are among the largest materials by 

12 volume that are used within the toy industry, and so that 

13 would provide a lot of relief. Although many of these other 

14 materials do have specialty applications within toys. 

15 So here is our rationale. First of all, we have 

16 testing from our members, in some cases for years, which 

17 we've submitted to the Commission on previous occasions, has 

18 found these to be absent over and over and over again. 

19 Additionally, TIA members, some of them have utilized an 

20 automated system that will look at bills of material and 

21 bills of substance from the suppliers and the raw materials 

22 suppliers that indicate that these phthalates are not in 
38

1 these materials. For instance, we have over 600,000 data 

2 points, and I'll get to a breakdown of that in a moment.

3 What we did was we did an automated run on all of 

4 these materials that were in the database. We looked at the 

5 six restricted phthalates. And then just to make sure, 

6 because I know there is some concern that manufacturers 

7 might be switching to other phthalates to avoid the 

8 restrictions, we actually expanded that list to some other 

9 likely candidate, phthalate esters, ortho-phthalates. And, 

10 frankly, of the 600,000, one or more of the 14 target 

11 phthalates were only found in 34 cases. 

12 One case was phenyl formaldehyde. It was a 

13 thermalset resin, which is very uncommon in the toy 

14 industry. It is typically used for electrical goods. One 

15 was in a non-polymer liquid formulation, but the balance was 

16 all in PVC. That's where we found it, and I'll get to that 

17 in a moment. So I think the data in combination with the 

18 knowledge of the material and the process, certainly gives 

19 us a high degree of assurance. I would submit that 600,000 

20 plus data points is a very significant chunk of data.

21 The phthalates that we looked for, obviously, we 

22 looked at the restricted ones, and we also looked at some 
39

1 others that might serve as substitutes, if someone were 

2 looking to avoid the restricted list and look at other 

3 phthalates as plasticizers. We also looked at di-methyl and 

4 di-ethyl phthalate, because we know that even though they're 

5 not typically used as plasticizers, there's been some 

6 concern about them, and they occasionally can be used in 

7 some products. 

8 And so these are the frequency of evaluations that 

9 were done. For ABS, we had 84,000, almost 85,000 runs; 

10 polyethylene, 56,000; and we'll provide, obviously, these

11 data to the staff for you to take a look at. Over and over 

12 and over again, an evaluation of these bills of substance 

13 indicates that the phthalates are just not present. All 

14 right. And here is where we did find them, and we've 

15 indicated by cast number which phthalate was found in which 

16 material. 

17 So in summary the accessibility determinations, we 

18 think, should reflect the hazard more closely than it does 

19 today. We think certain materials probably should always be 

20 tested. Other materials, we believe, should be exempt, 

21 either based on their rigidity or on their material 

22 composition. They should be exempt from routine 
40

1 certification testing, because we know a lot about the 

2 process. We know a lot about the material. We've reviewed 

3 bills of substance. We have test data. So we've looked at 

4 70,000 plus unique materials, and, as I said, only found it 

5 34 times. So I would submit that that certainly meets the 

6 threshold of a high degree of assurance. 

7 The cost to industry to test these materials where 

8 phthalates are not present is about $25 million annually. 

9 So this is a significant cost savings. And, again, we're 

10 not seeking relief from the requirement to comply. What we 

11 are seeking relief from is needless testing that tells us 

12 something we already know, that the materials are not there.

13 Thank you.

14 [Applause.]

15 MS. CAMPBELL: Thank you, Al. 

16 I would like to welcome Sheila Millar up now. 

17 [Slide presentation.]

18 MS. MILLAR: Thank you, Jacqueline, and I want to 

19 thank the Commissioners and the staff for organizing this 

20 workshop. It's very important today to look at ways to 

21 assure compliance while reducing the burden of test costs. 

22 So I'm here today representing the Fashion, Jewelry and 
41

1 Accessories Trade Association. Let me just start, very 

2 briefly, by telling you a little bit about FJATA. It has 

3 about 225 members; most of their members are small 

4 businesses. 

5 FJATA led the drafting of the Children's Jewelry 

6 Safety Standard, which has been recognized by the 

7 Commission, especially in terms of the cadmium limits, 

8 establishing an appropriate safety standard. And I want to 

9 recognize Kris Hatlelid and the work of her group in 

10 developing the background research that led to the cadmium 

11 recommendations. Also they've adopted an "adults" jewelry 

12 standard and it's now in the process of leading the ASTM 

13 subcommittee in updating those standards. 

14 So why am I here today? Obviously, jewelry is not 

15 a toy. It's not a childcare article. So how is the jewelry 

16 industry affected by phthalates testing? And it's because 

17 of the marketplace. The distribution chain as a result of 

18 interest in phthalates -- the requirements for testing for 

19 toys and childcare articles -- has begun imposing testing 

20 requirements that map CPSC’s, even on categories of products 

21 that don't require testing. And so the implications of CPSC 

22 action to recognize exemptions, which establish the lack of 
42

1 the presence of regulated phthalates at levels that will 

2 exceed the limits of the standard, will be significant, even 

3 for products that aren't subject to the compliance 

4 obligation. 

5 And, by the way, while we see this, we've started 

6 to see these testing requirements affecting children's 

7 jewelry. We're also seeing it affect adult jewelry as well. 

8 So the testing burden is significant. And because of the 

9 practice of component testing, I'm going to give you a 

10 little show and tell, and give you some examples of how 

11 that's affecting the industry. So I have a few examples. 

12 We'll get this on camera, maybe, of different kinds of 

13 children's jewelry. 

14 So you can see these are some bracelet sets. 

15 These are necklace and bracelet sets. So one of the common 

16 aspects of children's jewelry is what? A lot of different 

17 colors, different shapes, different sizes, lots of beads, 

18 lots of fun. And these happen to be examples that are on a 

19 flexible chord. What does that mean for test cost? So what 

20 we've seen, because of the lead testing and what's common in 

21 the jewelry industry -- and what's very common in many of 

22 the toy industry membership as well -- is if you can't 
43

1 control the manufacturing, because you're buying products 

2 and maybe assembling what's purchased, you end up testing 

3 each component. 

4 Because the cost of testing for phthalates is so 

5 high, we are talking about $3 to $400 a test. For items 

6 like these, each of which contain 8 to 15 components, let's 

7 do the math. We're talking about $2400 to 6000 to test a 

8 set like this. So this would be, maybe, at $400 per 

9 component, this would be a $6,000 test item. For children's 

10 jewelry, it's very common to have small lots of product. So 

11 6,000 items of jewelry would be a huge run of products. 

12 That adds one dollar, one dollar to this set. And so that 

13 illustrates, I hope, why the issues of reducing test costs 

14 is so important to industry as a whole. 

15 The smaller the industry, the smaller the run of 

16 products, the more significant the test burden is and the 

17 more it hits the ultimate consumer in the pocketbook, 

18 because those costs have to be passed on. So the jewelry 

19 industry, because the requirement in the supply chain for 

20 testing phthalates is one of relatively recent duration, we 

21 don't have 600,000 data points. We have a few data points, 

22 but what we do have is very consistent with the data that Al 
44

1 outlined this morning. 

2 When phthalates are present -- and there are 

3 certain types of flexible jewelry, children's jewelry --

4 analogs to like the live strong bracelet, for example. But 

5 in children's size, that's not a children's product, where 

6 you would maybe have a flexible PVC item, or something that 

7 might be plasticized with an ortho-phthalate. But the 

8 available data that we've seen from FJATA members is also 

9 very consistent with what Joel outlined and what Sanjeev 

10 outlined, unlike the toy industry. 

11 Because the test requirements are relatively 

12 recent, we don't track it back to the specific types of 

13 products. But what we have found in the testing is that the 

14 types of plastics -- and again, most of these are rigid 

15 plastics -- except maybe the little flexible band, are not 

16 present. Either they're non-detectable, or the highest 

17 level that we have seen of any regulated phthalates. And 

18 the only one that was detected in the test that I have seen 

19 is DEHP, which we think might have been used as a carrier 

20 for a colorant, or else could be contamination somewhere 

21 along the way, was present at less than 25 percent of the 

22 limit. 
45

1 So we think that that provides some good, 

2 supporting documentation that supports Al's outline of 

3 information of what we expect we would find in the typical 

4 types of plastics that are used in children's jewelry. And 

5 the typical types of plastics are going to be very similar 

6 to what you use in the toy industry. What we've also seen 

7 is that because they're primarily rigid we agree that 

8 materials with a Shore hardness rating of 90 or above, at 

9 least based on the information that we've seen, are not 

10 likely to contain phthalates. 

11 And as Al's outlined, as a practical matter, only 

12 certain types of plastics like flexible PVCs, certain types 

13 of polyurethane, which are not polyurethanes, are not common 

14 in children's jewelry, will not contain phthalates. We 

15 think that this type of information provides a high degree 

16 of assurance that you can exclude materials within the 

17 plastics category as not likely to contain phthalates. 

18 Issuing a rule that recognizes this point, will not just 

19 help the regulated companies, the regulated toy and 

20 childcare industry, but will have much more significant 

21 effect in reducing the overall test burden and costs that 

22 are affecting consumers today beyond the categories of 
46

1 regulated products. So thank you very much, and I'll turn 

2 it back to Jacqueline.

3 [Applause.]

4 MS. CAMPBELL: Thank you, Sheila. 

5 We'll have our last presentation for this panel in 

6 just one moment, Kyra Mumbauer.

7 [Slide presentation.]

8 MS. MUMBAUER: My name is Kyra Mumbauer. I'm the 

9 Senior Director of Global Regulatory Affairs for the Society 

10 of the Plastics Industry. And on behalf of this panel, I 

11 want to thank the Commission for organizing this workshop --

12 this is a great help to us -- and for giving us an 

13 opportunity to reiterate some of the recommendations that 

14 we've made over the years, for opportunities to reduce the 

15 testing burden to our members, and ensure the ongoing 

16 compliance of plastic childcare articles and children's 

17 products with the phthalate limits. 

18 I'll state up front that I myself am not a 

19 technical expert. So I may be even more the antithesis of 

20 what you're looking for today. But I do represent many, 

21 many technical experts within the plastics industry. And as 

22 questions arise, I'll be happy to take them back to our 
47

1 members. So just as a brief introduction, SPI is the trade 

2 association representing all segments of the U.S. plastics 

3 industry supply chain. 

4 We have material suppliers who sell resins, 

5 colorants and additives, recyclers who sell post-consumer 

6 and post-industrial materials, processors, both large and 

7 small who fabricate plastic consumer products and 

8 components, equipment manufacturers. And, finally, we have 

9 brand owners now who sell consumer products and package 

10 goods as well. And we've been engaged, really, since the 

11 beginning of the rulemaking process for the associate 

12 testing rules, and we've appreciated opportunities like this 

13 to have a robust, stakeholder dialog. We appreciate it. 

14 And so today I'm really just going to focus on a 

15 few misconceptions, some of which we've heard. So I'll keep 

16 my comments brief to the extent they duplicate some that 

17 have already been made. The first and chief misconception 

18 that we see, you know, really out there in industry, not 

19 only for purposes of compliance with these rules, but also 

20 in types of questions that our members are receiving from 

21 retailers and other end customers. This misconception is 

22 that all plastic materials used in children's products and 
48

1 childcare articles must be tested to ensure compliance with 

2 the phthalate limits. 

3 Some of this confusion appears to be due to a 

4 discrepancy, really, between the testing, the statement of 

5 policy in 2009 for testing of component parts with respect 

6 to Section 108 of the CPSIA, and then the 2011 notice of 

7 requirements for accreditation of third-party, conformity 

8 assessment bodies.

9 The 2009 statement of policy, which we looked at 

10 earlier, lists a number of plastic materials that will not 

11 contain the restricted ortho-phthalates in excess of a 

12 thousand parts per million. However, the 2011 notice of 

13 requirements includes a much narrower list, and it doesn't 

14 even mention any plastics among those materials. So that 

15 was of concern.

16 We've asked the Commission, and we'll ask again 

17 now, to please publicly identify the many types of plastic 

18 materials that will not contain the restricted ortho19 phthalates in excess of the specified limit. So, you know, 

20 responding to a couple of questions in the workshop notice, 

21 how or why continued manufacture, regardless of origin, 

22 would continue to be compliant with the phthalates limit. 
49

1 And what other technical, practical or implementation issues 

2 should CPSC staff consider before possibly making 

3 recommendations to the Commission regarding a phthalates 

4 determination for a plastic. 

5 What our members have assured us is that ortho6 phthalate plasticizers may be intentionally added to 

7 flexible; again, but not rigid. Polyvinyl chloride, 

8 polyvinylidine chloride, chlorinated polyvinyl chloride, and 

9 thermoset polyurethanes to make these materials flexible. 

10 They will not be added, the ortho-phthalates will not be 

11 added to rigid plastic materials, nor will they be present 

12 as contaminants at levels higher than a thousand parts per 

13 million, because they actually compromise the rigidity of 

14 these materials and affect the performance of the final 

15 rigid product. So it's a quality issue at that point. 

16 Ortho-phthalates are also incompatible with many 

17 plastic materials as we've heard, and some of those will be 

18 made flexible by other means. We are grateful to our 

19 colleagues at the Toy Industry Association who undertook the 

20 expense and the time to collect all of the data, and it 

21 really just confirms what our organization has reiterated 

22 for years that phthalates are not added to rigid, plastic 
50

1 products. 

2 So, here again is a list. This is the very same 

3 list that Al had put up on the screen earlier, beginning, of 

4 course, with rigid plastics with a Shore A hardness of 90 or 

5 greater, and including the other resins into which these 

6 ortho-phthalates that are being restricted would not be 

7 added. 

8 There is a further misconception that cross9 contamination may lead to the unintentional presence of the 

10 restricted ortho-phthalates in a great deal of plastic 

11 products. But the reality is that manufacturers have a very 

12 strong incentive not to allow this to happen. Plastic 

13 manufacturers, including those using recycled materials, are 

14 making sure that phthalates would not be present at these 

15 elevated levels, because it affects the end performance of 

16 their product. Phthalates, as I said, are also incompatible 

17 with polyolefins. They'll attack styrenic materials. And 

18 these are the materials that are most widely used in 

19 children's products: polypropylene, polyethylene, 

20 polystyrene, acryilonitrile, butadiene and styrene. 

21 On a further note, PVC is also incompatible with 

22 these materials. And we've learned that North American 
51

1 manufacturers by and large are not running PVC and these 

2 other materials in the same molding facilities. PVC, when 

3 actually blended with these other materials, can cause very 

4 serious problems, you know. It will chemically attack some 

5 of the resins in polyethylene. And in polypropylene, the 

6 processing temperatures used are much higher than those for 

7 PVC. So the PVC, if mixed somehow in a recycling stream, 

8 for example, or during an accidental blending in a plant, 

9 would decompose and you'd see black flecks come up in the 

10 resin. 

11 So what we've understood from manufacturers, and 

12 also recyclers, is that they take care and introduce careful 

13 process controls in to their manufacturing to ensure that 

14 there wouldn't be cross-contamination. Gaylords are 

15 carefully marked. Folks on the floor are trained very 

16 carefully. In the event that there were a cross17 contamination, most cases you'd see off-spec parts being 

18 produced, and it would be immediately obvious to those on 

19 the manufacturing floor that a problem had occurred. In 

20 some cases, machinery will actually be shut down, and we'd 

21 have to go through a careful purging process in order to 

22 start up again. 
52

1 So manufacturers are not looking to fall into 

2 those situations where they would have a costly shut-down, 

3 be unable to meet orders, and, you know, risk the reputation 

4 of their companies as well. So just on a final note, our 

5 recommendation is that the Commission please specify that 

6 rigid plastic materials with Shore A hardness of 90 or 

7 greater will not contain the restricted phthalates in excess 

8 of specified limits. 

9 We also ask that the Commission publicly identify 

10 the many types of plastic materials, and we've provided a 

11 suggested positive list that will not contain the restricted 

12 phthalates in excess to the specified limits. And, if so, 

13 we would prefer that this be done through a rulemaking 

14 process so that the entire stakeholder community will be 

15 aware and our retailer customers and others will be 

16 consistent in observing them. 

17 So with that I'll thank you and put up my contact 

18 information. As I said, I'm happy to go back to our members 

19 to get any questions addressed that you may have from here 

20 forward. Thanks.

21 [Applause.]

22 MS. CAMPBELL: Thank you, Kyra. 
53

1 In just a moment we'll open up the panel to 

2 discussion and questions. Just real quickly I want to 

3 remind you of a couple of things that Randy's already 

4 mentioned. And one is that when you have a question or 

5 before you speak, I think for the panelists -- the 

6 transcriptionist has it -- but if you come up to ask a 

7 question, be sure to state your name before you ask the 

8 question so that we know who you are. And also once you're 

9 finished speaking for the panelists and for our CPSC staff, 

10 remember to turn off your microphone. 

11 With that, just a note for the audience. You will 

12 need to come up here to use the microphone so that we can 

13 get it for our Webcast. But I'll be here to assist you with 

14 that. So with that, I think we can open this up to 

15 questions. Joel, go ahead.

16 DISCUSSION

17 DR. RECHT: First I'd like to thank the panelists 

18 for the talks. They're very helpful, but one thing that 

19 concerns me is to expand upon what you talked about, for 

20 especially Al and Kyra, your examples. In Al's case, the 

21 number of samples tested that didn't have phthalates or, 

22 Kyra, about the difficulties in quality if they were to be 
54

1 unintentionally incorporated. You know, I'd like to know, 

2 and perhaps the members of the plastics industry association 

3 could help provide some technical data on things like how 

4 much things degrade. You know. Is there a graph of 

5 phthalate content versus Shore hardness for PVC in different 

6 shapes and geometries, different filler contents that could 

7 be available? You know. Just how off quality are we 

8 talking about, if these things get in? 

9 You mention PVC in the stream being incompatible. 

10 We regulate products that are lower quality than some of 

11 your members produce as well as those that are of the 

12 quality that your members produce. If you look at our 

13 reports, we will recall -- or not necessarily recall, but 

14 stop, deny entry at the ports more than the number of 

15 samples for phthalates than the Toy Industry Association's 

16 testing showed in PVC. 

17 So how off-spec would these things be? If you 

18 could get us some of that information, and it's not just PVC 

19 in the recycle stream that might, but regrind or 

20 contamination elsewhere in the plant. But what about those 

21 other things like coatings and adhesives, and things like 

22 that, that might be in the recycle stream. If you could get 
55

1 us some information on is it that you can't make a part? 

2 You know. It simply won't form or that it's just going to 

3 be a second quality that will sell at a low price point?

4 MR. KAUFMAN: Thanks, Joel. You've asked a lot of 

5 questions. Let me see. If I don't get all of them let me 

6 know. I'm first of all not surprised at the data that 

7 you're seeing at the ports, but if you're seeing it, I would 

8 assume it's by and large flexible PVC, which we're proposing 

9 would not be excluded. So, clearly, there are some people 

10 who haven't gotten the message. And I think the 

11 interdiction efforts at the ports have done a good job of 

12 capturing those before they get into the stream of commerce.

13 PVC, as you can probably appreciate as a chemist, 

14 is an inherently unstable material because of the chlorine 

15 content, so it's typically processed at fairly low 

16 temperatures. It requires very special equipment 

17 modifications. Usually, the tools, for instance, have to be 

18 hard chrome-plated, or they have to be made out of stainless 

19 steel, because when you mold it, it evolves hydrochloric 

20 acid vapor, which will tear up most steel molds and other 

21 materials. Same for the screw in the injection molding 

22 machines -- usually chrome. So if you are a processor and 
56

1 you want to make sure that you're not getting PVC into your 

2 mix -- and that's typically what would happen is it would 

3 get in there by accident. And that's why, typically, PVC 

4 molders mold PVC and others don't do a lot of PVC molding, 

5 particularly on the rigid grades. 

6 So we have had some information from manufacturers 

7 who have said, look. I've brought in a Gaylord of material

8 that was recycled, and there was some PVC mixed in with it 

9 inadvertently. I had to evacuate the plant for six hours, 

10 because that's what happens is when you process it at such a 

11 high temperature, it immediately degrades. You get an 

12 evolution of that hydrochloric acid vapor and a lot of other 

13 nasty pyrolysis products, and you know right away that 

14 there's a problem. 

15 So getting PVC mixed back into the stream is 

16 typically not an issue. And in terms of using recycled 

17 materials, if you're molding PVC and you're using recycled 

18 PVC again, we are not proposing that flexible PVC not be 

19 tested. We think it should be. So, and again maybe I 

20 should clarify. What we're proposing is that for certain 

21 molded articles. I would certainly not make the case that 

22 adhesives or coatings should be exempted. We know that very 
57

1 often paints that are applied to flexible substrates do 

2 contain phthalates, because the paint film itself has to 

3 remain flexible. 

4 Polyvinyl acetate adhesives, as Dave referred to, 

5 I mean we know that PVA and acrylic adhesives typically do 

6 contain phthalates, and so, again, we wouldn't propose that 

7 adhesives be exempted. On the other hand, we are testing a 

8 lot of rigid, molded parts that we know the materials are 

9 not going to be in there. And so, you know, what we're 

10 looking for is some relief on testing it, finding out it's 

11 not there, testing it again, finding out it's not there, ad 

12 nauseum. Does that answer all of your questions?

13 DR. RECHT: Yeah. I mean those are the lines of 

14 what I'm looking for. Again, to the extent any actual 

15 experiences from your members could be brought to us as 

16 evidence of how that degradation occurs, and, you know, how 

17 much is tolerable. You know. If you have one percent PVC 

18 in the mix, can you get away with it? Or, half a percent, 

19 or is it 10 percent? Or, you know, where is that, and then 

20 we can do the math that might or might not lead to things 

21 like that. 

22 MS. CAMPBELL: Okay. Go ahead, Randy.
58

1 MR. BUTTURINI: For our webcast people, this is 

2 Randy Butturini again from CPSC. I have a couple of 

3 questions. Some are just to make sure I understand, and the 

4 first one is for Dave Owen. Talk about the flash point of a 

5 phthalate being typically greater than 200 degrees C. Are 

6 you talking about the temperature which it combusts, or does 

7 that mean something else?

8 MR. OWEN: Pretty much. Flash point is a specific 

9 test where you wave a flame over the material as it's heated 

10 up, and you see when it starts to ignite. And then when you 

11 remove the flame, it stops. But that's the definition of 

12 flash point. 

13 MR. BUTTURINI: Thank you. Then for Mr. Gandhi, 

14 in your presentation you talk about Shore hardness issues. 

15 Can you explain more what you mean by there's an issue using 

16 Shore hardness to determine phthalates content?

17 MR. GANDHI: Yeah. Shore hardness is a non18 intrinsic material property. It's something that manifests 

19 based on the type of construction of the material. And 

20 there are external factors that influence the determination 

21 of the net outcome of that Shore hardness measurement. So, 

22 typically, thickness could be one of the big factors. You 
59

1 know. The thickness effects in materials had it all on what 

2 different material properties or mechanical properties come 

3 out to be. 

4 So Shore hardness, in particular, in case of thin 

5 materials and thick materials as they are used in that 

6 finite thickness in the actual product when you measure it, 

7 the results will be different. So a plastic, which is 

8 deemed to be an original material and qualify against the 

9 criteria of 90 Shore hardness at some level may not be the 

10 same Shore hardness determination when you have that actual 

11 material tested in finished form because of the thickness 

12 effects.

13 MR. KAUFMAN: If I could comment on that one as 

14 well, I think Sanjeev is absolutely correct when you are 

15 talking about materials that are significantly lower than 90 

16 Shore A. Just to explain how a Shore hardness test works, 

17 it uses a penetrometer and it's a spring-loaded needle. And 

18 so the device measures the distance that that needle 

19 penetrates into the material. 

20 So for something which is above 90, which is 

21 essentially rigid material, the thickness effects that 

22 Sanjeev mentions are much less critical. In other words, if 
60

1 something's rigid, it's going to be rigid whether it's a 

2 quarter-inch thick or a half-inch thick. On the other hand, 

3 if you are trying to determine whether something is 50 or 60 

4 Shore A, absolutely thickness becomes very critical at that 

5 point. 

6 MR. BUTTURINI: Well while we're talking about 

7 Shore A, I'm curious. Where did the number 90 come from? 

8 Why 90 and not some other value? And do you have data 

9 showing that at around 1,000 parts per million or .1 

10 percent, you can discriminate using the Shore hardness test 

11 between compliant and noncompliant materials. 

12 MR. KAUFMAN: It's somewhat arbitrary that the 

13 Shore A scale runs from zero to a hundred. And so anything 

14 above 90 typically you're not getting much penetration at 

15 all of the needle, and therefore those are considered to be 

16 essentially rigid materials or stiff enough to resist the 

17 penetration of the needle. There are actually definitions, 

18 and I believe ASTM F963 actually contains a definition of 

19 rigidity, and I think the number is 70. I'd have to go back 

20 and check. In other words, the flexible materials are 

21 defined as less than 70, so.

22 MR. BUTTURINI: Do you have like experimental data 
61

1 of compliant and noncompliant materials that you measure the 

2 Shore hardness of, and you can see the difference? And, you 

3 know, 90 is where the interesting things happen, or 

4 something like this, or was it something a lot harder than 

5 70? I'm still curious about why 90 and not 89 or 91, or 72, 

6 or some other number.

7 MR. KAUFMAN: As I said, it's somewhat arbitrary. 

8 In other words, I think there's general agreement that a 

9 material that exhibits a Shore hardness of 90 or above is 

10 essentially rigid, and that's why that number was chosen. 

11 And, again, we don't have a correlation between Shore 

12 hardness and test data indicating absence of phthalates. 

13 What we're saying is that a Shore hardness above 90 

14 essentially indicates a rigid material, and rigid materials 

15 are known not to have phthalates added as plasticizers. 

16 MR. BUTTURINI: This isn't a question, but it's 

17 one of the things that we're interested in, and it's a magic 

18 word, one of the magic words, and it's "how." And when you 

19 say something is known not to contain phthalates, and what 

20 we're interested is “how do we know this is not known to 

21 contain phthalates, and can an entire package of material be 

22 put together?” You know, this plus this, and here's some 
62

1 test data and here's some other things. And put all 

2 together, it says, yes, I have a high degree of assurance.

3 There's that other word that does not and will not 

4 in the future be compliant. So when statements are made 

5 that this is known not to do this, instantly we get curious 

6 about that. And we think, okay. How can we show that to be 

7 the case? And that's what we're interested in is putting 

8 this package together, or putting some kind of logical and 

9 scientific, empirical, scientifically defensible -- another 

10 special word from our operating plan -- body of knowledge 

11 together; not just data and not even just information, but 

12 knowledge about something so that we can say, yeah, this 

13 makes sense that a determination can be made for these 

14 materials or these materials under these circumstances, or 

15 whatever else. That's what we're looking for. That's what 

16 we're trying to find, and that's sort of why we're here. 

17 MS. MILLAR: Well let me take a crack at outlining 

18 an approach. I think there is a lot of data and Al's 

19 industry -- the toy industry -- has done a lot of the work 

20 there to establish through test data the absence of the 

21 presence of prohibited phthalates in excess of the amounts. 

22 The relatively small amount of data that the jewelry 
63

1 industry has done, tracks very nicely with that, but we 

2 don't have the cross-polymerization of the type of plastic.

3 Kyra's presentation I think outlined the typical 

4 process considerations, and because of how you make 

5 products, how you mold plastics, the likelihood that you're 

6 going to use the same mold and the same equipment to make 

7 flexible versus rigid products is small. And because we 

8 know that there are only a few types of plastics that have 

9 historically contained the ortho-phthalates -- and that is 

10 changing as well -- the reason that you don't mold anything 

11 in the same plant with PVC would be equally true, regardless 

12 of where you were making the product. 

13 I think it's also clear that for children's 

14 products, while there may be some specialty products that 

15 are made with recycled plastics, it's very rare. It's not 

16 at all common in the jewelry industry, for example. Al can 

17 speak to the toy industry, but I think it's more of a 

18 specialty niche where they advertise the products as made 

19 from recycled content. And because of the lead issue, you 

20 typically -- at least with toy industry folks that I'm 

21 familiar with -- would not use the mixed plastic stream. 

22 So you would try to get a clean plastic stream 
64

1 like HDPE laundry detergent jugs as your source material, 

2 and then make whatever you're going to make. But you're not 

3 bringing in PVC for the same contamination reasons that Kyra 

4 explained. And because the process problems relate to what 

5 happens if you have PVC resin in your stream, it's a lot of 

6 incentive to avoid that by good process controls up front.

7 MR. KAUFMAN: And if I could add to that, I think 

8 Sheila is absolutely correct. The use of recycled material 

9 in the toy industry, at least, is relatively limited. And 

10 the reason for that is that because toys are so highly 

11 regulated and have to meet a number of physical properties: 

12 drop tests, torque tension, et cetera, using recycled 

13 materials. Every time a material goes through a heat 

14 history -- every time it's molded -- you end up with some 

15 degradation of the physical properties of that material. 

16 And so it doesn't make sense for people to take that risk in 

17 most cases. So they usually use virgin material. 

18 The only recycled material, I guess, if you can 

19 call it that is that for instance if you mold something the 

20 screws and the runners are typically reground and fed back 

21 into the system at controlled rates, no more than 10 percent 

22 usually. But that's really the only use of what you could 
65

1 call recycled material. It's not post consumer. It's too 

2 important and too critical for people to know exactly what 

3 they're molding their product out of.

4 DR. RECHT: Well I guess going back to Kyra, I 

5 think your industry, again, might be able to provide 

6 information if you could go back to them. Again, we've 

7 talked about these quality problems at these different 

8 levels. Manufacturers have problems take place at their 

9 plants. I worked in industry as a manufacturer before, and 

10 sometimes we made off quality product; and, eventually, you 

11 learn if I add this much of this, this is what happens. So, 

12 again, if we could get data on what those Shore hardness 

13 versus accidental phthalate contaminations are, things like 

14 that, that would be helpful. 

15 You know. On the use of recycled content, again, 

16 if any of you can look beyond just your member base but to 

17 the worldwide production, among the samples we see that we 

18 test here from port surveillance, there are samples that 

19 appear to have recycled content. We find three or four 

20 different phthalates in the same, component part on a dollar 

21 toy. It seems unlikely to be engineered to that extent that 

22 they want one percent of this one and three percent of that 
66

1 one. So, you know, if you can help us with the wider look 

2 at that, we'd appreciate it.

3 MS. MILLAR: Yeah. I think we can definitely go 

4 back and get more information for you on that. One thing I 

5 will mention is that one of our members had said that in the 

6 past there were concerns about flexible parts coming in from 

7 other parts of the world, potentially not being manufactured 

8 up to specification using the material requested. It was 

9 difficult in some cases to distinguish between what was 

10 supposed to be a TPE and was, in fact, made with a cheaper 

11 PVC plus the size with phthalates. But across the board --

12 and we can get the data on hardness. 

13 To the extent possible, we'll work on that. But, 

14 really, what I think we're asking is for rigid plastics 

15 there wouldn't be that same issue. Just anywhere in the 

16 world you wouldn't see people with the incentive to try to 

17 run different materials with PVCs that could be plus the 

18 size with the phthalates in the same plant. So I think 

19 that's really where the rigid distinction is really key for 

20 us.

21 DR. HATLELID: My name is Kris Hatlelid. I'm a 

22 toxicologist with the CPSC. And your response just reminded 
67

1 me of something that I jotted down earlier, and it has to do 

2 with the questions we had in the FR notice about practical 

3 implementation issues, and that has to do with problems with 

4 or mistakes with identity of a material. And, of course, 

5 we're dealing with a lot of overseas manufacturers. So the 

6 folks who are responsible for compliance in this country 

7 weren't standing in the plant. So what is the sense of 

8 mistakes in identity if we're talking about known phthalate 

9 containing materials are possible and known not phthalate 

10 containing materials? 

11 MR. KAUFMAN: Yeah. I think -- if I understand 

12 the question correctly, Kris, I think you're asking if you 

13 exclude certain materials, let's say that the Commission 

14 decides to exclude materials by composition. How do you 

15 confirm that those are actually the materials being used? 

16 And, again, that comes down to good manufacturing practice 

17 and good process control. 

18 And even if you are in a situation where you're 

19 receiving something from an outside supplier -- and you 

20 didn't witness it being produced -- I would expect that you 

21 would take reasonable steps to confirm that material 

22 identity. On the other hand, using portable FTIR to 
68

1 identify materials, or in the case of polyolefins, all you 

2 really have to do is throw it in a glass of water. If it 

3 floats, it's a polyolefin. 

4 [Laughter.]

5 MR. KAUFMAN: I mean those are the sorts of things 

6 that could provide significant testing relief, because the 

7 phthalate test, as Sheila mentioned, is quite expensive. It 

8 takes several days. And so we're really looking for 

9 something. We're not saying don't test anything. What 

10 we're looking for is something that is much less expensive 

11 and much faster that would allow us to make a decision with 

12 a reasonable degree of assurance -- a high degree of 

13 assurance -- that phthalates are not there. 

14 MS. MILLAR: Let me add one more point to what Al 

15 said, and that's there is a market reality here for any 

16 children's product, which is subject to a lot of testing. 

17 There has been a great effort with the responsible 

18 manufacturers to deal with the supply chain. So I think 

19 it's customary, for example, in the jewelry industry, 

20 because they're testing products after they purchase it, 

21 after they're made. They're made overseas. They come over 

22 here. They're tested before they go onshore and then are 
69

1 often retested here in the U.S. So you have that double2 check. But it's pretty much a two-strikes rule. 

3 If you fail once, you're on sort of a special 

4 watch. A supplier who fails twice is typically dropped, and 

5 that word does get out through the supply chain. So the 

6 suppliers actually have an enormous incentive, also because 

7 of the efforts of AQSIQ to promote safety and compliance 

8 within China, for example, where a lot of these products are 

9 made. And so we've seen evidence that the AQSIQ folks are 

10 also evaluating products, evaluating plants and evaluating 

11 processing to assure that the products that are produced in 

12 China will meet standards for the U.S. market so that China 

13 doesn't get a black eye. 

14 So I think there are some additional market 

15 realities that are at play here that are useful to keep in 

16 mind. They're not the same as data, but there is a lot of 

17 testing, and there are ways -- and sometimes very simple 

18 ways -- as Al has described, to double-check the identity of 

19 the material. 

20 MR. BUTTURINI: I have a question for Mr. Kaufman. 

21 In your presentation you're talking about the rationale for 

22 things to have determinations made on them. And part of the 
70

1 rationale was evidence from process, knowledge and process 

2 controls. And I wrote down on my notes, "Does everyone do 

3 this?" That would be one of things that we'd want to know 

4 about, because you could understand. You know, a body of 

5 knowledge would be we think everybody does this because of.... 

6 There's the magic word, again, "because of," you know, this 

7 and this and this. It costs too much to do it any other 

8 way. You get the best quality this way -- whatever the 

9 rationales are on this thing. 

10 If the members of the TIA, which represent 85 

11 percent of the U.S. market do this, well you might know 

12 about 85 percent pretty directly, because you can just ask 

13 them. And what we're interested in knowing is what do we 

14 know about the people that aren't the members of TIA? And I 

15 don't want to say what they're up to, but what sort of 

16 processes and things they're working on. 

17 And I just have one other question. I want to get 

18 this clear. Evidence and review of materials supplied bills 

19 of substance. Other people in manufacturing would call that 

20 a bill of materials?

21 MR. KAUFMAN: Actually, it's one step below the 

22 bill of materials. In other words, the bill of materials 
71

1 tells you what, for instance, that high impact polystyrene 

2 is used to mold a particular part. You go one level below 

3 to the bill of substance, and that high impact polystyrene 

4 is broken down to all of the components that make it up. 

5 And that's what it was based on. 

6 MR. BUTTURINI: And, typically, this is a 

7 question. Typically, I assume that producers who supply 

8 bills of substance are not third-party tested. They don't 

9 send their material to a third-party laboratory. They 

10 develop the information themselves in-house. Is that right?

11 MR. KAUFMAN: They develop the information in12 house, and they don't typically send it to a third-party 

13 laboratory. In fact, that's one of the issues that we do 

14 run into. So thank you for bringing that up. Most resin 

15 suppliers have invested tremendous amounts of money in-house 

16 laboratories to characterize and qualify their materials. 

17 And, in fact, many of our manufacturing members indicate 

18 that they get certifications from their suppliers saying 

19 that phthalates are not present. 

20 However, they can't rely on that as part of the 

21 component part testing rule, because it was not tested at a 

22 third-party laboratory. It was tested at the in-house 
72

1 laboratory of the resin supplier. And, again, these 

2 suppliers have tremendous incentives to know what they're 

3 dealing with, because they're risking a plant explosion if 

4 there are things in there that they don't know about. And 

5 so they're very, very careful about what the inputs are. 

6 They're very, very careful about characterizing the 

7 materials to make sure that it meets all of the 

8 specifications that it needs to meet, that it meets impact 

9 strength, that it meets melt-flow index, clarity, any number 

10 of physical properties that are going to be critical to 

11 their customers. 

12 MS. MILLAR: Maybe I can ask one question for the 

13 staff, and that is on lead. You exempt stainless steel of 

14 certain grades. So how does the staff determine which 

15 grades of steel, because they don't have to be third-party 

16 tested, would qualify, and could that same approach be 

17 applied to exempt phthalates?

18 MR. BUTTURINI: Well our metallurgist isn't here 

19 to explain that explicitly. I can give general details in 

20 that composition of stainless steels was determined. And if 

21 you look at industry documents that talk about steels --

22 this type and that type and all the different numbers of 
73

1 this sort of thing and the other thing -- and all the way to 

2 differentiate in the UBS numbering system is one that's 

3 used, it overlaps with several other systems. They list 

4 materials, and the materials include, of course, iron and 

5 carbon, and phosphorous and sulfur and the other things that 

6 make up whatever steel you're making. 

7 And then there's another category of either other 

8 undefined, or they actually list particular materials, 

9 including lead. And they'll say "less than" such and such 

10 amount, because less than will not affect the chemical and 

11 mechanical properties you're looking for in that kind of 

12 steel. So if steel is qualified as a particular UBS number 

13 type steel, then it was considered to have less than that 

14 amount. 

15 There are a couple of steels, stainless steels, 

16 especially, that have more than one hundred parts per 

17 million lead. In rough terms it was that kind of process.

18 MS. MILLAR: So for the jewelry industry where you 

19 might use some stainless steel in children's watches, for 

20 example, higher end children's watches, the typical approach 

21 would be to get a supplier assurance that the steel meets 

22 the grade appropriate in the lead exemption so it doesn't 
74

1 have to be tested, because it is excluded from testing. So 

2 that's on the lead side, but I think it's a similar issue. 

3 MR. BUTTURINI: Yeah. We're talking about 

4 phthalates now, and we've got plenty of time to talk about 

5 leads later.

6 MR. GANDHI: If I may, I want to go back to the 

7 previous questions about the bill of substance. The way 

8 it's constructed is a lot of information from upstream 

9 suppliers that moves up and it's aggregated in that former 

10 bill, material bill of substance. So third-party labs 

11 normally do not create that bill of substance or verify in 

12 any shape or form. 

13 That would entail a massive assay type of work, 

14 chemical assay type of work to create that bill of 

15 substance. So it's just aggregating the information from 

16 all the upstream suppliers to build that matrix of what 

17 materials are and what substances, like additives, pigments. 

18 So he stabilizes a free list, classified those. Whatever 

19 level of substances are added at what level, that's how it's 

20 created. 

21 MR. BABICH: I'm Michael Babich from CPSC, and I 

22 just have a couple of questions. You have list of polymers 
75

1 that don't contain phthalates for various reasons, because 

2 they're not compatible or won't mix with the polymer or they 

3 adversely affect the properties. Is there any data that 

4 would say, for example, that the phthalates can't mix with 

5 polystyrene or some other polymer at 0.1 percent. You know. 

6 You're saying it's not miscible, but could you say at that 

7 low level, or is there a lower limit? There's got to be, 

8 you know. Maybe it's a part per billion. I don't know, but 

9 I'm wondering if there's any data like that. And for the 

10 example of the polystyrene where phthalates would adversely 

11 affect the properties, again, do you know is there a limit, 

12 or maybe someone has data to that effect? 

13 MR. KAUFMAN: Michael, I'll take a shot at trying 

14 to answer that. Clearly, there is a limit. I don't know 

15 that anybody has done any work to say that it's exactly this 

16 number. The only thing I can offer is maybe some anecdotal 

17 data from my time in the toy industry. It's always been an 

18 article of faith that you never -- and this goes back to the 

19 days before phthalates were restricted. It was an article 

20 of faith that you never put high impact polystyrene in 

21 contact with flexible PVC. And the reason for that was that 

22 just a small amount of phthalate migrating to the surface of 
76

1 that PVC would attack the high impact styrene and actually 

2 would weld the two materials together. So it actually would 

3 create a solvent bond between the two. So it doesn't take 

4 much for you to degrade the properties of that material. 

5 That's all I can tell you. I can't give you a number. 

6 MS. CAMPBELL: Are there any other audience 

7 questions? We do have it open up here. It's okay to come 

8 up. Any other questions from the staff? 

9 MR. UHL: Hi. I'm Rick Uhl, also with CPSC. I 

10 know you said, typically, recycled plastics aren't used in 

11 your industries, but because we have to look at all the 

12 scenarios that are out there, there is that possibility that 

13 a recycled material could be used. And I was wondering if 

14 you had recycled material, like a non-PVC material -- let's 

15 say polyethylene or something like that. In the recycle 

16 process could there be an accidental percentage of PVC 

17 that's part of that recycle process? 

18 Because, obviously, if you had some PVC with 

19 banned phthalate in there that got mixed into the recycle 

20 process, then you could have a theoretical non-PVC, 

21 typically safe plastic, that would then suddenly have an 

22 unexpected, banned phthalate. And it may be at the 0.1 
77

1 percent level. So that's my question. And I'd like to say 

2 if you don't have the answer to that question, that would be 

3 the type of information we'd be looking to get, you know, 

4 from technical experts in the field. Thank you. 

5 MR. KAUFMAN: And I think the answer to that is we 

6 don't have an answer that, again, what is the de minimis 

7 level of PVC that could be tolerated as a contaminant. The 

8 one thing I would say is that it's probably not much, and if 

9 you consider that even if you mold in flexible PVC, 

10 phthalate levels, if it's added as a plasticizer or 

11 somewhere in the 40 to 50 percent range -- or 30 to 50 

12 percent range depending on what type of flexibility you're 

13 looking for. 

14 So when you talk about a small amount being mixed 

15 into a stream at 30 to 40 percent, you're probably going to 

16 be much lower than that thousand part per million threshold. 

17 But I, again, don't have experimental data that would say, 

18 you know, you could tolerate one percent without noticing 

19 it, typically because of the fact that it won't mix and the 

20 processing temperatures are so much higher with other 

21 materials than for PVC. 

22 As Kyra mentioned, it degrades. It carbonizes, 
78

1 and you end up with black specks, and so you would know 

2 right away -- not to mention the fact your eyes would be 

3 watering as you molded it because of the hydrochloric acid 

4 vapor. 

5 MR. BUTTURINI: I have a question for Mr. Kaufman.

6 Because he has the longest presentation, he always has the 

7 most number of questions. This is Randy Butturini from 

8 CPSC. You're talking about -- it's not a question. More 

9 it's a here's how. There's that word again, the magic word. 

10 He made the statement that "Thermoplastic polymers -- you 

11 know, PETE, PBT, PCT -- are flexible, but despite their name 

12 do not contain phthalates." And then you get to what would 

13 be useful and interesting to us would be to add "because 

14 of," you know, reasons, A, B, C. 

15 And when that's put together we can say "Oh, now I 

16 understand what you're going about." Now I understand, and 

17 maybe I can understand this at a high degree of assurance. 

18 I need to ring a bell every time we say one of these words. 

19 MR. KAUFMAN: Okay. Let me take a stab at that 

20 one. The name is very similar, and the reason is that they 

21 are produced using terephthalic acid as a starting material. 

22 So that is not an ortho-phthalate. That is a terephthalate. 
79

1 And I'm sure the staff can explain that when you have a 

2 benzene ring, the materials can be attached at different 

3 locations around the ring. So terephthalic acid is attached 

4 at a different point on the benzene ring than ortho5 phthalate acid, which is used to produce phthalates. And so 

6 even though you have the term phthalate in that material, 

7 that's what I was trying to point out. It does not contain 

8 ortho-phthalates. It starts from terephthalate.

9 MR. BUTTURINI: And then that gets to my second 

10 statement, and these two are now going to overlap each 

11 other. The one you say, "Some materials are plasticized -

12 nylon 11, 12 and cellulosics." "Some materials are 

13 plasticized" -- excuse me -- "nylon 11 and 12, and 

14 cellulosics, but not with the regulated phthalates." And 

15 what I'd be interested in hearing about, and that's always 

16 true "because of;" or, these are produced using 

17 terephthalates always because of. You know, that sort of 

18 thing that gets us towards the "will not" part. 

19 So we can try to close that loop where we need to 

20 work ourselves. What about this? Or what about this? And 

21 is this even possible? No. It's not possible. That sort 

22 of thing; that's the sort of information we're looking for. 
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1 And a wonderful place to put that would be regulations.gov, 

2 docket CPSC-2011-0081, and you have until April 17th to do 

3 that sort of thing.

4 DR. RECHT: Just following up on that, for 

5 instance, with the PETE, which is the kind of plastic that's 

6 used in like a two-liter soda bottle, for instance. You 

7 mentioned that the polyolefins float versus the PVCs sink. 

8 PETE is also a dense plastic. And that's actually, you 

9 know, in the recycling stream. The floating is used 

10 somewhat to separate the different polymers, but it's 

11 potentially, you know, a greater risk of contamination of 

12 PVC into PETE. Just due to densities. 

13 You know. You said phthalates aren't used in 

14 PETE. But, again, is there a tolerance level for PVC and 

15 PETE that's different than what you were saying in terms of 

16 polyolefins' processing temperatures? And even in the case 

17 of polyolefins, is that true also for film products or only 

18 for molded products? Are they processed at lower 

19 temperatures for calendared films and things like that? If 

20 you could provide us with some of that information, 

21 especially the SPI, that might be helpful. 

22 MR. KAUFMAN: And we can certainly get those data 
81

1 for you. And I think what's helpful is that in the case of 

2 some of these materials, the number of manufacturers are 

3 relatively small. For instance, Eastman produces a huge 

4 percentage of the PETE; same for the cellulosic material. 

5 So we can certainly go back to them and see if they have 

6 some of these data. 

7 DR. HATLELID: Well this should be quick. I just 

8 wanted to clarify something that came up in a couple of 

9 presentations. Sanjeev, you mentioned in the hardness, what 

10 you were presenting in the hardness, you mentioned issue 

11 with styrenics. And then we've talked about styrenics is 

12 not typically being a phthalate-containing. So I just 

13 wanted to clarify what you meant by that. Is it just with 

14 the rigidity testing in styrenics or with the phthalate plus 

15 rigidity testing, plus styrenics?

16 MR. GANDHI: Yeah. Earlier I had misspoken about 

17 the styrenics as an example of that additional hardness 

18 being effective, because then I corrected it. Other type of 

19 elastomeric materials where plasticizer may be used, and 

20 then the Shore hardness as a proxy indicator may not be 

21 valid.

22 MR. BUTTURINI: Could I ask Jacqueline to put Mr. 
82

1 Kaufman's phthalate presentation back up on the screen, 

2 because I want to just pop between two pages and ask a 

3 clarifying question? 

4 [Slide.]

5 MR. BUTTURINI: My question is materials which do 

6 not require certification testing -- and here's the list of 

7 materials and it continues on to page 12 and maybe beyond 

8 that -- okay -- three pages worth. My question is really 

9 pretty simple. If you could go back to page 9, these are 

10 the materials that don't require certification testing, 

11 you're saying "because of" the reasons and the rationales 

12 given on page 9. It's that kind of connection?

13 MR. KAUFMAN: Well it's several things. First of 

14 all, we know from the process that these materials are not 

15 produced with phthalates. There's no feasible means for 

16 phthalates to find their way into the process stream in 

17 terms of producing the material. In addition, we also have 

18 test data for those materials, in which I think some of 

19 which we've provided already to staff on previous occasions. 

20 And, third, we also have the bills of substance data of the 

21 70,000 unique materials which have been evaluated based on 

22 the bills of substance. So it's really you've got three 
83

1 branches of data, I guess, for lack of a better term.

2 MR. BUTTURINI: Okay. To follow up on the list on 

3 page 11, while you were talking, you mentioned phthalates 

4 are typically not utilized and they're typically not exposed 

5 to phthalates. And my question is about the word "typical." 

6 Do you mean typical as in never? Or typical as in most of 

7 the time? Typical as in it would take a strange set of 

8 circumstances to do something? How typical is typical?

9 MR. KAUFMAN: Good question. And, by the way, let 

10 me reiterate that when I list these materials I'm talking 

11 about molded or extruded parts where we're talking about 

12 solid plastic parts. Some of these materials are used, as 

13 mentioned earlier, in adhesives and in coatings. And those 

14 are -- I don't have any data on those. In fact, I would be 

15 surprised if some of those materials did not contain 

16 phthalates or potentially contain phthalates. So we're 

17 talking about molded plastics here. 

18 And to answer your question, "typically" was meant 

19 to imply that if somebody could -- I don't know why they 

20 would, but somebody could intentionally add phthalates to 

21 them, but there's certainly no reason to do that. There's 

22 no property that you would gain from doing that. Phthalates 
84

1 are fairly expensive materials. You wouldn't use them as a 

2 filler. I mean there's no logical reason to do it and no 

3 logical reason to find them there. 

4 MR. BUTTURINI: That's great. And is this list 

5 just for the resins made from these things, or is it after 

6 they've been formed into component parts or children's 

7 products?

8 MR. KAUFMAN: We're talking about the resins, and, 

9 again, it's always possible, although unlikely, that 

10 colorants, for instance, might contain small amounts of 

11 phthalates. But if a manufacturer is using component part 

12 testing and they can test the colorant, but not have to test 

13 the natural resin, that still gains them in terms of testing 

14 relief. 

15 MR. BUTTURINI: I just have another clarifying 

16 question. As long as we're here, if we could go to page 16, 

17 the rational test BOM and BOS data, and the name and the 

18 frequency are listed. These are evaluations of BOMs and 

19 BOS’s? Is that what this is?

20 MR. KAUFMAN: That is correct. Sorry. Each of 

21 those frequencies is the number of times that material was 

22 evaluated based on a review of that bill of substance. And, 
85

1 again, you come up with something north of 600,000, total. 

2 Now that represents multiple runs of some materials, because 

3 there are only 70,000 unique materials that are represented 

4 here.

5 DR. HATLELID: I just mentioned to Randy that he 

6 just asked one of my questions. I'll ask you, maybe again, 

7 and what I was thinking about in terms of practical and 

8 implementation wise. And that had to do with when we're 

9 talking about these individual plastic resins and then their 

10 colorants and other things, you briefly mentioned there's 

11 still opportunity for burden reduction there, even when the 

12 finished component or product is considerably more complex 

13 than just the resin. 

14 MR. KAUFMAN: Correct.

15 DR. HATLELID: Did you want to expand on that? 

16 MR. KAUFMAN: Absolutely, Kris, and, you know, 

17 clearly, even though the primary way that a phthalate is 

18 going to get into a part is it's used as a plasticizer; and, 

19 typically, those use levels are pretty high as I mentioned, 

20 you know, in the 30 to 50 percent range to get flexible PVC. 

21 On the other hand, you know, there is an outside chance that 

22 phthalates could be used as a carrier. 
86

1 Regulated phthalates could be used as a carrier in 

2 things like colorants or heat stabilizers, or any of the 

3 other additives. But I should qualify that statement. That 

4 applies largely to PVC and allied materials, because those 

5 phthalates are typically already in the formulation and are 

6 miscible or compatible with PVC. In the case of 

7 polyethylene it would be very unlikely to find it there, 

8 again, because you're going to have a hard time getting it 

9 to mix. You know. Even at fairly low levels, it's just not 

10 going to solubilize in the material, even at high 

11 temperatures.

12 MR. BUTTURINI: I have another question, and this 

13 actually deals with scope of relief, the widest scope of 

14 relief. What we have right now is the guidance document 

15 from 2009, which is not a regulation. It's a guidance. And 

16 my question would be there are materials expected not to 

17 contain phthalates, and that could actually be a long list 

18 of materials not expected to contain phthalates. 

19 My question is if we mention some things, or we 

20 actually have a determination that here are some materials 

21 that are not expected to contain phthalates -- that nobody 

22 expected to contain phthalates in the first place, such as 
87

1 titanium -- how much would the scope of relief be on things 

2 that we don't expect? You know, and you could probably make 

3 a reasonable case with a high degree of assurance it's not 

4 to be an exotic material like natural gemstones and high 

5 melting point metals, and things like this. Would there be 

6 a scope of relief? Do you observe people having to test 

7 exotic materials, unfinished woods, for the presence of 

8 phthalates? 

9 MR. KAUFMAN: In some cases, yes, and here's why. 

10 And I'm glad you brought that up, Randy, because what we're 

11 looking for is relief in the form of a regulation similar to 

12 what was done with lead at 16 C.F.R. 1500.91. And the 

13 reason for that is because very often retail customers are 

14 not going to allow exclusion of testing unless they can 

15 point to a regulation. Even the guidance document has not 

16 been enough for some retail customs. 

17 In fact, just before this session, I actually 

18 talked to a couple of retailers and said are you allowing 

19 people to exclude materials based on the guidance document. 

20 And they said, "Absolutely not. If it isn't a regulation, 

21 we're not going to allow it."

22 DR. RECHT: Just to follow up on that, you know, 
88

1 again that would be an area where some of you or your member 

2 companies might have data that could help. You know, even 

3 BASF, the phthalates will decompose or boil at these 

4 temperatures and the processing temperatures of this metal 

5 is higher than that. Or, you know, things along those lines 

6 for that other range of products would still be very useful 

7 to us. We've been talking mostly about plastics, but all 

8 that same how and why information for other non-plastic 

9 products would be useful. 

10 MS. MILLAR: So, again, while jewelry is not a 

11 regulated product for phthalates and we have started to see 

12 phthalates testing being required by the supply chain, the 

13 information I have doesn't suggest that it's being required 

14 for any metals, because metals are known not to contain -- I 

15 mean they wouldn't have phthalates. 

16 We have also heard from some members that they 

17 have been successful in talking to suppliers and to their 

18 test laboratories about using Shore hardness as an 

19 exclusion. So if you're talking about scope of relief, 

20 categorically excluding rigid plastics, we think there's a 

21 high degree of assurance based on the available data that 

22 those products will not contain phthalates. And the reason 
89

1 I mention the steel exemption on the lead side is that to 

2 the extent what we see, practically speaking, in the supply 

3 chain, as we see supplier assurances that that product, that 

4 is that product that it meets that exemption. So the 

5 supplier assurance, because you have false advertising and 

6 warranty and other liability exposure, gives the supplier 

7 the incentive to make sure that the product conforms with 

8 that assurance. 

9 So I think there are some ways that we could 

10 practically talk about that would provide a high degree of 

11 assurance that the component or the material would not 

12 contain any of the prohibited phthalates, and there might be 

13 a combination of techniques that we could talk about to 

14 achieve the highest possible degree of assurance, because 

15 that's what everybody wants. 

16 MR. BUTTURINI: I'd like to follow with some 

17 advice and then one other question on the long list of 

18 materials that started on page 11. In terms of scope of 

19 relief, Sheila Millar mentioned that rigid plastics would 

20 provide a wide scope of relief. If we could get, perhaps, a 

21 comment even submitted saying here's a ranking order of 

22 things that would provide wide scope to narrow scope; or, 
90

1 here's a group that would provide wide scope. So if you 

2 have to do something on an individual level or if you have 

3 to do something as a class, the greatest relief would come 

4 from doing this first. Then turn your attention to the 

5 second and the third, or however it might turn out. 

6 That would be a useful thing for us to know. And 

7 I have a question for Kyra Mumbauer on your second to last 

8 slide. You recommended to publicly identify the many types 

9 of plastic materials that are known not to contain the 

10 restricted phthalates in excess of the specified limits. 

11 There's more than one way to publicly identify that. And my 

12 question is are you agreeing that a regulation similar to 

13 1600 C.F.R. 1500.91 to lead would be the sort of public 

14 thing you want; or, are you thinking of something else?

15 MS. MUMBAUER: No. That's exactly right --

16 through a rulemaking process; and, part of the reason is 

17 just to ensure that everyone pays attention and adheres to 

18 that carefully. To the point about scope of relief that was 

19 raised earlier, one of the challenges that our members face 

20 is that even outside of the scope of regulated products, 

21 these children's products and childcare articles, there are 

22 instances where retailers and other customers will ask for 
91

1 testing of plastics that we discussed here today that would 

2 not contain the restricted phthalates -- just to be sure --

3 even though they're not trying to comply with the 

4 Commission's regulation specific for children's products. 

5 So we're talking an enormous amount of relief, if 

6 an agency of the U.S. Government were to come out and make 

7 publicly available this information about the classes of 

8 materials that wouldn't contain these restricted phthalates. 

9 So I agree with that from a legal perspective. A rule 

10 provides the most specific assurance and comfort to the 

11 supply chain about what does not need to be tested. But we 

12 know that rulemakings take time. 

13 And so to the extent more immediate relief in the 

14 form of updated guidance or commentary from the Commission 

15 could be provided, I think that could also be helpfully used 

16 in the supply chain to assist in reducing the cost of 

17 unnecessary testing. Because those costs -- I mean we 

18 haven't quantified it for the jewelry industry because it's 

19 a pretty new phenomenon for phthalates, but I think Al puts 

20 some numbers up and those costs testing doesn't get cheaper 

21 over time. Typically, it gets more expensive. 

22 And so the net result will be some reduction in 
92

1 choice, some reduction, maybe, in the number of components 

2 that you use because of that burden of testing. So, again, 

3 I think we should be looking creatively at ultimately a role 

4 which would provide the most assurance and relief, but other 

5 techniques that could also provide useful signals to the 

6 marketplace about the view of the Commission in areas where 

7 there is a high degree of assurance that unnecessary testing 

8 can be avoided.

9 MS. CAMPBELL: Do we have any questions from the 

10 audience? No? Any other questions from staff? 

11 MR. BUTTURINI: I just have one more. One more 

12 statement is that we're talking about providing a wide scope 

13 of relief. And in the Federal Register Notice, one of the 

14 questions we ask is what sort of things might have to be 

15 done to assure the “will not” part in addition to the “does 

16 not” part; will not be non-compliant versus does not need to 

17 be non-compliant. 

18 Now there's that body of knowledge that we're 

19 trying to put together again. You know. These materials do 

20 not have the prohibited phthalates because of this. And 

21 they will not have the prohibited phthalates because of 

22 these other things, or they're unlikely in the future is 
93

1 always a little uncertain. They will not, with a high 

2 degree of assurance, because of these factors, you know. 

3 They're always subject to change in the future, but that 

4 could be keep an eye out for this, and you will continue to 

5 have “will not.” 

6 That's sort of kind of path that we might be able 

7 to take to come towards the determination with a high degree 

8 of assurance. That would be very useful information, that 

9 kind of process together or that kind of argument together.

10 MR. KAUFMAN: And I would say just to sort of 

11 build on that a little bit, Randy, I think one of the 

12 difficulties for industry and also for the staff is that 

13 it's impossible to prove never. And so I think having that, 

14 being able to build a case that says, look. It's not

15 introduced intentionally. There's no logical path for it to 

16 get in there as a contaminant. 

17 I mean to me that would qualify as a high degree 

18 of assurance, because it's just not going to be there unless 

19 someone intentionally sabotaged the process. And that's 

20 very, very unlikely. In the case of these materials that 

21 we're proposing, there really is no reason for phthalates to 

22 be there. You don't gain anything by adding it; and, in 
94

1 fact, in virtually all of the cases, you lose something by 

2 not being vigilant about making sure it's not there.

3 MR. GANDHI: I'd just like to add a comment, 

4 picking up on Sheila's comment about being creative. So 

5 from the lab side, we are always looking for opportunities 

6 to improve the testing process, making it quicker and

7 faster. And I would also say that as the time has 

8 progressed, the cost of testing for phthalates has come down 

9 tremendously. However, I just want to point out that we are 

10 always looking for new technology that can be incorporated.

11 And I remember two years ago there was a panel 

12 discussion here in this facility looking at some potential 

13 hand-held technology that may be on the horizon, and, 

14 unfortunately, it hasn't progressed. You know. I remember 

15 reaching out to some of those companies after that event; 

16 tried to learn more about it and how those opportunities can 

17 be further explored through a Beta testing kind of state, 

18 but, either, the technology hasn't matured on their end to 

19 share with us what can be done to bring that technology to a 

20 commercially viable solution. 

21 MR. COHEN: My name is Neal Cohen. I'm a CPSC 

22 staff member. I'm going to just play the rube here, because 
95

1 I am. This discussion about Shore hardness and rigidity, is 

2 this a standard spec in the industry? I mean I know that 

3 stainless steel numbering, as Sheila had noted in the lead 

4 determination, is a standard spec. Is this something that 

5 SPI members already include in the resins when they're sold 

6 at the substances level? Or is this another test that would 

7 have to be performed by the end product manufacturer, 

8 component part manufacturer after molding? In other words, 

9 are you replacing one more expensive test for phthalates 

10 with one less expensive test for Shore hardness? 

11 MR. KAUFMAN: Yeah. In general, Neal, the cost of 

12 testing for phthalates is fairly significant. The cost and 

13 time to do Shore hardness is very, very quick. As I said, 

14 it's just a penetrometer, a weighted penetrometer that gives 

15 you a direct read-out on a dial indicator as to what the 

16 Shore hardness is of the material. And to answer the other 

17 half of your question, yes, it is a very common way of 

18 specifying the hardness or softness of a material, at least 

19 within the toy industry. 

20 MR. BUTTURINI: I have a question. I just want to 

21 emphasize something that Mr. Kaufman said. The lead 

22 determinations that were done were done largely in part for 
96

1 things that can't contain lead greater than now 100 parts 

2 per million. But, for manufactured materials, it's not 

3 always -- you can't always use the word “can't” as easily, 

4 and that's why we intentionally put in a high degree of 

5 assurance, things like that, because we understand that 

6 “can't” is pretty hard to do. And when you combine can't 

7 and won't, that's even harder to show scientifically. 

8 So that's why a high degree of assurance is in 

9 there. We know there is uncertainty. There is uncertainty 

10 in process. There is uncertainty in product. There is 

11 uncertainty in measurement, and there is certainly 

12 uncertainty in the future, and we are trying to take that 

13 into account. 

14 MR. KAUFMAN: And I guess the only thing I can say 

15 in response is that at least in our view the likelihood of 

16 phthalates being found in some of the materials that we're 

17 proposing are probably lower than the likelihood of finding 

18 lead in some of the excluded materials in 1500.91.

19 MS. CAMPBELL: Okay. If there are no more 

20 questions, we can go ahead and break a little bit early for 

21 lunch. Thank you. We are going to reconvene at 1:15 for 

22 the panel on Lead and the ASTM 8 Elements solubility.
97

1 So enjoy lunch. 

2 If you haven't already gotten a copy, we do have 

3 some handouts about lunch options that are in the vicinity.

4 [Lunch break.]

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1 A F T E R N O O N S E S S I O N

2 MS. ADAIR: Good afternoon, everyone. We're going 

3 to get started with our next session. I hope everybody had 

4 a nice lunch and you're back and ready.

5 My name is Patty Adair and I'm with the Consumer 

6 Products Safety Commission for Engineering Sciences. This 

7 session will go very much like the one before, and I wanted 

8 to add a few reminders -- just housekeeping -- before we get 

9 started, and remind everybody that the workshop is being 

10 webcast and taped. The presentations given will be posted 

11 to SlideShare sometime early next week. I believe 

12 Jacqueline will probably send out a link. 

13 IV. LEAD AND ASTM 8 ELEMENTS

14 MS. ADAIR: So for this session, which is "Lead 

15 and the ASTM 8 Elements," we are going to start with the 

16 staff presentation and then follow that by presentations 

17 from our panelists and statements. And then, again, just 

18 like last time, we'll open the floor to questions and some 

19 discussion. And the staff presentation will start with Kris 

20 Hatlelid.

21 [Slide presentation.]

22
99

1 DR. HATLELID: Good afternoon, everyone. So as 

2 Patty just said, we're going to talk about lead and the 

3 other elements in the F963 Toy Standard, and a little bit of 

4 background. We talked a little bit this morning. People 

5 mentioned already that some years ago the Commission 

6 determined a set of materials that do not exceed the current 

7 100 per million lead content limit, and therefore not 

8 subject to the third-party testing. 

9 And the citation here, 16 C.F.R. 1500.91. At the 

10 same time, we put together some procedures/requirements for 

11 lead content determinations, sort of a guidance to petitions 

12 for stakeholders who would be interested in seeing other 

13 materials undergo the same sort of review. And that's at 16 

14 C.F.R. 1500.89. As we talked about this morning with the 

15 phthalates, we have a set of very similar questions to 

16 discuss today and in the future. 

17 For manufactured materials, we would be interested 

18 in learning about the specific information and data that 

19 staff should assess in considering a recommendation that the 

20 materials production does not and will not result in lead 

21 content above that limit. We are interested in the effect 

22 of recycled materials, what could happen during recycling 
100

1 and introduction of recycled materials into manufactured 

2 products, and the potential for contamination. 

3 We are looking for what specific information and 

4 data should be obtained to assure that continued production 

5 of the materials for future manufacturer, regardless of its 

6 origin, will continue to be compliant with the lead content 

7 limits. And what other information should the staff 

8 consider before potentially making recommendations to the 

9 Commission. 

10 Because we already have a list of lead determinations and a 

11 procedure, we wanted to ask about whether there might 

12 potentially be changes that one might want to see to the 

13 existing procedures, whether something should be clarified, 

14 simplified, added to, and, again, that citation is 16 C.F.R. 

15 1500.89. And we would be interested in more information 

16 about some materials that intrinsically or inherently, sort 

17 of versus manufactured products, but materials that by their 

18 nature do not contain lead above the current limit. And is 

19 that information available? As with the phthalates, we 

20 would like to explore where we could make the most of our 

21 potential activities in terms of burden reduction and cost 

22 savings. 
101

1 So now we're going to switch to the ASTM heavy 

2 elements. We're going to have some of the same sorts of 

3 issues we want to explore, but a little bit of background. 

4 The toy standard has in it, in addition to lead, so there 

5 are 8 elements. One of them is lead. It has its own 

6 requirements. The other 7 are antimony, arsenic, barium, 

7 cadmium, chromium, mercury and selenium. And I just wanted 

8 to point out that the basis of that standard is solubility 

9 of the chemical from the material or migration from the 

10 material; that’s how the test is done. 

11 And we're going to talk a little bit about

12 thinking about solubility of the elements from material as 

13 well as content. The current version of the toy standard 

14 has an optional test for content and that was under the

15 consideration that if a test is being conducted already for 

16 lead content, the other elements could be included for only 

17 a marginal increase in cost. So they tend to be amenable to 

18 testing all together. And because the lead test is for 

19 content, the other tests would also be for content. 

20 As we've talked about before with the other two 

21 chemicals, what materials, by their nature, do not and will 

22 not contain any of these elements above the solubility 
102

1 limits? I'll read that one again. In content, above their 

2 solubility limits. So that goes to the optional test for 

3 content. Content is not required. Content limits are not 

4 required for these elements, but it can be the basis for a 

5 test. So we can look at determinations based on content.

6 The second question on this slide has to do with 

7 the solubility. So how do we address thinking about 

8 solubility? How do we know whether the chemical present in 

9 a material or component part, or a product, will be below 

10 the limits. It's the same sort of concept as the 

11 determinations for phthalate content and lead content, but 

12 we're talking about solubility in that case. 

13 So, a related question. How can we think about solubility 

14 limits and whether compliance with those limits can be 

15 inferred from content? If we know something about content, 

16 whether it's below the solubility limit or not, can we know 

17 something about the potential solubility? And that needs to 

18 consider the characteristics of the product.

19 We heard a little bit about this with phthalates 

20 as well. It's not necessarily what's going on with the raw 

21 material. It's the shape, the configuration once you make 

22 the component of the product. And, again, what are the 
103

1 avenues to explore for the greatest cost reduction and 

2 burden reduction in pursuing some of these questions? And, 

3 a general question: What other information should we 

4 consider before potentially making recommendations to the 

5 Commission? 

6 So Patty will be moderating this session, and she 

7 will introduce each of our panel participants. I'll go 

8 through the list, the six of them, before I turn it back 

9 over to Patty. 

10 Nikki Brown from Penn State University; Bill 

11 Perdue for the American Home Furnishings Alliance; Mark 

12 Fellin from the Juvenile Products Manufacturer's 

13 Association. We've met Al Kaufman from the Toy Industry 

14 Association; Hailey Mann from the American Plastic Toys; 

15 and, we've also met Sanjeev Gandhi from SGS Consumer Testing 

16 Services. 

17 MS. ADAIR: Thank you, Kris, for that very 

18 informative presentation. I'm going to invite Dr. Nikki 

19 Brown from Penn State to come up and tell us a little bit. 

20 Introduce yourself, your bio.

21 DR. BROWN: Good afternoon everybody. My name is 

22 Nikki Brown. I'm here from Penn State. I'm in the 
104

1 Department of Ag and Biological Engineering, and my 

2 expertise is wood, wood chemistry, wood adhesives. So Rick 

3 asked me to come and comment about not just raw wood and the 

4 exemption that it qualifies for, but also wood composites 

5 and what kinds of heavy elements we might see in those 

6 materials, coatings and paints. We'll talk a little bit 

7 about recycled wood also.

8 So I don't have a formal presentation with slides. 

9 I'd just like to offer some comments based on some 

10 literature review and some discussion with some colleagues 

11 in industry. So to begin with I'd like to give credit to 

12 some people who provided some information to me -- Dr. World 

13 Nieh and his colleague Alan Rudie at the USDA Forest 

14 Service. My grad student Brett Diehl also provided some 

15 time and energy searching some literature for me for today. 

16 So thanks to them. 

17 For raw wood, as you guys know, it qualifies for 

18 an exemption, because all of these eight elements of 

19 interest are considered trace compounds. The literature 

20 that we were able to dig up on that supports that. When you 

21 look at the ASTM F963, Table 1, the limits for each of 

22 those, based on our literature search, we were well under 
105

1 the limits. So the exemption is supported. It's also 

2 interesting to note that the highest levels of those 

3 materials occur naturally. We find it in leaves, roots, 

4 small branches and bark. And, of course, those are the 

5 parts of the plant that are least likely to be found in 

6 toys. 

7 So even some of those elements that may have been 

8 in the higher range or close to our limits might have been 

9 found in plant tissue that would not be present in toys. 

10 There is of course variation in species, so some of the 

11 literature that we found also is most relevant to species 

12 that we might use in pulp or paper, or other commercial 

13 building materials, which again might not be consistent with 

14 what is found in toys. So just pointing out some of the 

15 limitations of the information that's available in the 

16 literature. 

17 If we move on and think about wood composites, 

18 since the '80s, there's been a big boom in composite 

19 technologies, mostly because we can be more efficient with 

20 how we use wood. We chip it up into small particles, and 

21 then we glue it all together to make big products out of 

22 perhaps lower quality wood elements. So the big question 
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1 there is if wood is okay as it is, and it doesn't have heavy 

2 metal levels that are a problem, well what happens when you 

3 throw in some adhesives? 

4 And adhesives are the main thing that we would 

5 worry about. There's very little other additives to 

6 composites that would be heavy metal based, perhaps some 

7 waxes or things like that that would be more organic in

8 nature would be more typical. But the different resin 

9 technologies that are used for composites include amino 

10 resins, like urea formaldehyde, melamine formaldehyde, 

11 isocyanate. 

12 If you're looking at solid wood that has been 

13 glued together, small, clear blocks of wood, that would be 

14 polyvinyl acetate, primarily. And then there's also 

15 phenolics, but again, some of these composite materials 

16 would be very rarely found in wood. The particle board or 

17 MDF that you might find in some toys or puzzles would 

18 probably be an amino type resin, and they're—talking with 

19 one of the major U.S. suppliers, Momentive—they indicated 

20 that they don't use any catalysts or additives that would 

21 include any of the eight heavy metals.

22 So something where there's a chain of custody or 
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1 paperwork supporting what kinds of additives are provided to 

2 a manufacturer could perhaps be a way to get around a 

3 laborious or expensive testing process. For paints and 

4 finishes, like adhesives, there's very little published 

5 literature available. Most of this is kept in industry 

6 knowledge, trade secrets. But, again, discussions with a 

7 couple people -- I was able to speak with a colleague at PPG 

8 -- he indicated, again, very little of their current 

9 technologies use any of those additives in their paints. 

10 They would have used that, or they continue to use 

11 some chromium-based products for exterior steel applications 

12 where they need incredible durability. Some of their 

13 pigments may also contain heavy metals that, again, for 

14 interior type uses, the amount of these eight elements of 

15 interest is extremely limited. So, again, the thought that 

16 came to mind this morning as we were talking about this was 

17 a very similar process that's been undergoing for the wood 

18 composites industry, relative to formaldehyde emissions, 

19 where panel producers have had to demonstrate how much 

20 formaldehyde is being released in their products. And, 

21 again, there's third-party testing that's required. 

22 There's also an extensive chain of custody and 
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1 paperwork recordkeeping that's required; but exemptions are 

2 possible for technologies that have no added formaldehyde. 

3 So a very similar approach could work here where coatings or 

4 paints, or resins that have no added elements -- antimony, 

5 arsenic, lead -- perhaps a recordkeeping method similar to 

6 that Toxic Substances Control Act, Title 6, for 

7 formaldehyde. Perhaps a similar approach could be viable.

8 The wood products industry responded really 

9 favorably, actually, to this new EPA regulation after some 

10 consideration. They realized that it was actually a boost 

11 to their American competitiveness, relative to overseas 

12 products that may be coming in. This way, by providing 

13 certification and documentation to support their product, 

14 having very low formaldehyde emissions, that was an added 

15 value for them. And so their product became more valuable, 

16 so they were able to compete better with overseas 

17 operations.

18 Finally, just a few comments on recycled wood 

19 waste. This area is probably the one that we need more 

20 information about. As I was searching through the 

21 literature, there's a few articles in this area, but not 

22 much. And the one that I focused on was from Sweden in 
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1 2006. In Sweden there's a tremendous use of biomass and

2 biofuels for residential heat application. So they had a 

3 tremendous interest in what happens when they use recycled 

4 wood waste for that. 

5 What kind of heavy metal considerations need to be 

6 taken into effect? So they did a modeling approach based on 

7 some published data, and the numbers that they came up with 

8 put us right at the borderline of some of the acceptable 

9 limits that are published in the ASTM standard table 1, 

10 especially for arsenic. The arsenic level that they 

11 reported for recycled wood waste, the content was as high as 

12 53 parts per million of arsenic. 

13 Again, that was based on a lot of assumption. So 

14 more literature is needed. More work is needed in that area 

15 to document the levels of arsenic. Another one that was 

16 close was chromium at 60 parts per million, and again based 

17 on their assumptions. Probably those levels are coming from 

18 CCA treated woods, which CCA was the most widely used wood 

19 preservative from 1970 through 2004. In 2004 it was 

20 voluntarily pulled because of concerns with arsenic 

21 leaching. Just to give you an idea, CCA treated wood can 

22 contain anywhere from 1500 to 3300 parts per million of 
110

1 arsenic. So containing or controlling or limiting, or 

2 eliminating waste streams that contain CCA treated wood 

3 would certainly be necessary in my opinion. 

4 So that's just an overview of some information I 

5 was able to find about wood, and these 8 heavy metals. 

6 Thank you.

7 [Applause.]

8 MS. ADAIR: Thank you very much, Dr. Brown, for 

9 sharing that with us. And I'd like to welcome Bill Perdue 

10 from the American Home Furnishings Alliance.

11 MR. PERDUE: Patty, thank you, and good afternoon 

12 everybody. I am Bill Perdue. I am vice president of 

13 Regulatory Affairs for the American Home Furnishings 

14 Alliance, and I have the distinction of being a fourth 

15 generation furniture guy. So I've been in this industry all 

16 my life and actually saw my great grandfather come through 

17 this entire industry as well. At one time when I went to 

18 work for American in Lawrenceville, Virginia, we had three 

19 generations of my family working with one company. So I 

20 have a pretty good background in this industry.

21 Let me tell you a little bit about the HFA. The 

22 HFA is a trade association. We're the largest trade 
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1 association for the home furnishings industry. We have 450 

2 member companies. We do operate a very large domestic wood 

3 furniture manufacturing footprint, as well as a 

4 comprehensive and extensive global supply chain that does 

5 provide a wide variety of home furnishings to the American 

6 consumers.

7 Member companies basically provide approximately 

8 300,000 manufacturing jobs throughout the United States, and 

9 we represent a $35 billion segment of the industry. They 

10 were around a long time. Our trade association's been in 

11 existence for over a hundred years now. I want to focus, 

12 really, on composite wood products. I've spoken to the 

13 Commission and to staff sometimes about composite wood 

14 products, and this is something that over the last several 

15 years we've been testing. 

16 Our products, especially youth furniture, with 

17 relation to lead, mainly, 16 C.F.R. 1500.89, I think, is a 

18 great platform to be able to make a determination not to 

19 have to test composite wood products in our furniture. 

20 Composite wood products in household furniture, as component 

21 parts, do not contain lead in amounts that exceed the 

22 applicable lead levels specified by the CPSIA. Basically, 
112

1 these component parts should be exempt from the testing 

2 requirement for total lead content that's imposed by Section 

3 101(a). 

4 A preponderance of our test status since the 

5 inception of the CPSIA clearly revealed the absence of lead. 

6 The requirements to test are costly and very unnecessary to 

7 our industry. Composite wood products primarily consist of 

8 wood and glue, as you just heard from Dr. Brown. The 

9 Commission has previously stated that wood will not exceed 

10 the lead limits established by Section 101(a), and so wood 

11 in and of itself is exempt. Lead is not intentionally or 

12 inadvertently introduced into the manufacturing process.

13 Lead is not a routine or optional additive that 

14 contributes a positive characteristic to the finished 

15 product. There's no reason for us to put lead in it. 

16 There's no reason for us to have lead in our system. 

17 There's no reason for lead to be in the resin systems. 

18 There's no reason for lead to be present in these composite 

19 wood products that we use as component parts for finished 

20 goods. 

21 Dr. Brown stated there are four major glue 

22 suppliers to the wood products industry: Hexion, Arclin, 
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1 Georgia Pacific and AXA. The primary resin systems that are 

2 employed currently within the United States and offshore 

3 manufacturing are the more traditional or conventional urea 

4 formaldehyde resin systems, do not add formaldehyde resin 

5 systems and the ultra low emitting formaldehyde resin 

6 systems. All of these resin systems are under extreme 

7 scrutiny by the state of California with their carb 

8 regulation, and currently under the EPA proposed rule, again 

9 bringing this type of scrutiny to the resin systems that we 

10 currently use. 

11 These resin systems are basically water, urea and 

12 formaldehyde. There is wax in limited applications. These 

13 wax are organic in nature, 40 percent solids, some in the 

14 core glues we see from .5 to .75 percent in the entire make 

15 up. Some have 1 percent for the face glues, and those would 

16 be the glues that we use to actually put face veneer on top 

17 of these composite wood products. 

18 We do have an inherent challenge using wax in 

19 composite woods as component parts of furniture, especially 

20 youth furniture, and that's absorption and the adhesion of 

21 finishes. A lot of times if we've got too much wax or waxes 

22 found in the composite wood products, the finishing material 
114

1 just simply will not stick. It will bleed through the 

2 veneer face, and we get what we call fisheyes in the 

3 finishing room at that time. So it's an inherent problem 

4 that we see. 

5 The HFA a couple years ago, the outset of the 

6 CPSIA, did do a study for lead in composite wood products 

7 and component parts. We did contract with a CPSC certified, 

8 third party lab, and we had a broad sampling set. And when 

9 I say broad, that included both domestically manufactured 

10 composite wood products, as well as composite wood products 

11 from offshore. And, again, to define composite wood 

12 products, we were mainly looking at medium density fiber 

13 board and particle board. 

14 Both have very similar characteristics, but the 

15 fines in the MDF are that, they're fines, and they are part 

16 of the manufacturing off fall of furniture as we bring our 

17 component parts through the manufacturing process. And then 

18 in particle board, the particles are a little bigger, but 

19 again they are comprised of the off fall that is generated 

20 from the manufacturing of our component parts as we assemble 

21 those component parts to make furniture. 

22 Historically, the data that we've collected since 
115

1 the onset of CPSIA was verified by the study that we put 

2 together. We had been testing since 2009 under Section 101 

3 for composite wood products and lead. The testing really 

4 was the result of our supply chain demands. We as an 

5 industry had great pressure put on us throughout the supply 

6 chain from our customers asking us to test for lead and the 

7 composite wood products. And, basically, this really has 

8 generated a very sizeable repository of data points.

9 Regardless of where the composite wood product was 

10 manufactured, the data and the result of the study were the 

11 same. Our highest reading that we have, that we've seen to12 date, is four parts per million. The majority of all of the 

13 data points are non-detect. When we start talking about the 

14 manufacturing process and we start talking about recycled 

15 products, and looking at how, if lead could be introduced in 

16 the manufacturing process we use the quorum's "Life Cycle 

17 Inventory Report" for MDF and particle board.

18 Basically, when you look at the process of 

19 manufacturing these two composite product types, the 

20 manufacturing process is very closed. It is very simple, 

21 and it's linear in process. And it's highly automated. The 

22 closed nature of the manufacturing process, in our opinion, 
116

1 does not permit any opportunity for the introduction of 

2 lead. There is just no reason for it to be there, nor is 

3 there an opportunity for it to be introduced in the process.

4 Basically, from the saw mill to the finished 

5 product, and that's really from the log all the way down to 

6 the piece of furniture that you have in your home, products 

7 that include the process of wood chips fines that are the 

8 off fall of furniture production will have a resin system 

9 and wax. So really what they do is they take the log. 

10 We'll trim the log. We'll turn that into face veneer or 

11 into some type of lumber wood that is used in the 

12 manufacturing process. And then the other fines are 

13 generated through the manufacturing process. This would run 

14 these component parts through the manufacturing operation. 

15 Those fines are collected, basically. Those wood 

16 chips are collected. We store them. And then in a lot of 

17 cases they are pneumatically transferred from the furniture 

18 manufacturing facility, literally next door, to a plant that 

19 makes the mat, as it's called, the particle board mat or the 

20 MDF mat. In some cases we store these in siloes, and they 

21 are then transported by truck to the composite wood product 

22 manufacturer. Again, the system is very closed and very 
117

1 tight, and it does consist of basically wood chips and 

2 fines. 

3 Some of those wood chips and fines would be 

4 resinated, simply because of the fact that we're using 

5 composite wood products in the manufacturing process. And 

6 in order to make the mat, you have to use the wood chips 

7 with a resin system. That's how you get them to stick. And 

8 so as we make those component parts, we will get some 

9 resinated wood into our recycling stream.

10 Over the course of the last several years we've 

11 collected quite a bit of data using CPSC-CH-E1002-08, and 

12 also the ASTM 1479-99 method. One thing that came up here a 

13 while back that I thought was really interesting, there was 

14 an automotive glue. We were asked about an automotive glue, 

15 and it was sort of one of these issues of what if, what if 

16 this glue were on the shelf. Could it be used? 

17 We went back and we did a lot of research on that 

18 glue; and, yes, there is an automotive glue that does use 

19 lead in the catalyst to kick the reaction over. However, 

20 that glue has to be used in an electrostatic water bath. I 

21 think that if we're looking at reasonable determinations and 

22 reasonable assumptions, you're not going to take a piece of 
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1 wood furniture particle board and run it through an 

2 electrostatic water dip bath in order to use a lead catalyst 

3 in a resin system. So that's the something that continues 

4 to pop up, for whatever reason, and it's just impractical. 

5 We don't use it in our manufacturing system. We never 

6 would, and it would be impossible. 

7 So with that, I will close my remarks and thank 

8 the Commission, and thank the Commissioners for allowing us 

9 the opportunity to speak. And, again, we are very focused. 

10 What we are asking for is the determination for composite 

11 wood products, fines testing, and in home furnishings and 

12 youth furniture. Thank you very much. 

13 [Applause.]

14 MS. ADAIR: Thank you so much, Bill.

15 We are going to welcome Mark Fellin from the 

16 Juvenile Products Manufacturers Association. Mark?

17 MR. FELLIN: Thank you for giving me the 

18 opportunity to speak here today on behalf of the Juvenile 

19 Products Manufacturers Association. I appreciate the 

20 Commission taking the time to review this. On behalf of the 

21 entire industry, we certainly do appreciate it. A little 

22 bit of history about JPMA: JPMA represents 95 percent of 
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1 the pre-natal industry and we have roughly 250 members. 

2 I loved when Al spoke earlier, when he said that 

3 industry is not seeking any relief regarding compliance, but 

4 only relief from testing, which does not advance safety. I 

5 think when we consider JP products, I love to tell people 

6 that we have a great story. We're the only industry that 

7 has affected every single person in this room on a personal 

8 level. Everyone here at some point has used one of our 

9 products -- not something that our manufacturers take very 

10 personally. And we hold that to the highest regard in terms 

11 of safety. 

12 There are a couple of things that I want to 

13 address in my comments, and I know Al is going to go through 

14 kind of a lot more of the materials for exemptions that we 

15 share. One thing I want to address in particular -- and 

16 Sheila mentioned this earlier when she said the smaller the 

17 industry, the more the cost; and the smaller the production, 

18 the cost is still the same. With the JP industry, that 

19 hasn't been the case. 

20 Since 2007 'til now, the industry as a whole has 

21 absorbed all the cost of testing. We haven't put it back on 

22 the consumers. I think that's something important to note. 
120

1 For instance, the average cost of a travel system is roughly 

2 about $219. So when we were talking about the different 

3 types of materials, I know Al is going to talk about, for 

4 their average product it's $9. When you translate, that's 

5 $219 for our products, a significant cost. So I think 

6 that's something to be kind of aware of. 

7 Now, when Kris talked earlier, she said one of the 

8 things that they're trying to look at is changes to existing 

9 procedures. And I want to get this right here. So 16 

10 C.F.R. 1500.89 was crafted prior to the CPSIA amendment, 

11 which provided that CPSC may grant exemptions for products 

12 if lead is required, because it is not practicable or not 

13 technologically feasible to manufacture the product by 

14 removing the excessive lead or by making that lead 

15 inaccessible. The product, or any of its components, is not 

16 likely to be placed in the mouth or ingested, and the 

17 exception will have no measurable adverse effect on public 

18 health or safety, taking into account normal and perceivable 

19 reasonable use and abuse. 

20 I know that the main portion of this isn't focused 

21 on the idea of accessibility, but I think it's important to 

22 note, particularly as it relates to the cost of some testing 
121

1 for juvenile products. Back when Congress developed Public 

2 Law 112-28, they exempted certain products that they knew 

3 had a certain amount of component parts. For example, 

4 bicycles and ATVs were exempted as well as books, because of 

5 the lead content. 

6 JPMA is very similar in some of our products. For 

7 instance, for a play yard, when considering the rivets, 

8 tubes, caps, protective components, wheels, corner knuckles 

9 and many other components of play can cost -- that's cost in 

10 testing -- cost well over $2,000 in test costs, just for 

11 lead and substrates. So I think it's really important to 

12 note, kind of, as we're going through this discussion and 

13 you're trying to look at ways in which to reduce the burden, 

14 that you're looking at where things are actually accessible, 

15 and knowing that you have the authority to kind of look at 

16 that in greater detail.

17 So that's kind of the brief overview that I wanted 

18 to give, and I'm happy to answer any questions on the 

19 presentation. So, thanks once again for having me.

20 [Applause.]

21 MS. ADAIR: Thank you so much, Mark.

22 We're going to get a presentation up for Al, here.
122

1 [Slide presentation.]

2 MR. KAUFMAN: Hi, for those of you who weren't 

3 here this morning, and I suspect that almost everybody was. 

4 I'm Al Kaufman. I'm the senior vice president of Technical 

5 Affairs for the Toy Industry Association. Since most of you 

6 were here this morning, I'm going to speed through some of 

7 this. 

8 So, first of all, you don't need to hear again 

9 about the Toy Industry Association. But, again, just to 

10 reemphasize, and it's something that Mark spoke about, we're 

11 not looking for any relief regarding compliance. You know 

12 we believe that it's in everyone's interest that the product 

13 be compliant. What we do want some relief on is testing 

14 that tells us something we already know, and is essentially 

15 dollars that are being diverted from more productive 

16 pursuits that could be used to focus on other areas of 

17 safety. 

18 We're going to present some proposals and 

19 rationales. And, again, since I wrote this before I had the 

20 conversation with the staff, definition of accessible, 

21 again, same argument as with phthalates. In other words, 

22 the current definition of accessibility was primarily 
123

1 developed for sharp edges and sharp points, where touching 

2 it is clearly an issue. On the other hand, for heavy 

3 metals, oral ingestion is usually the issue, and so simply 

4 because you can touch something doesn't render it an 

5 exposure risk. We're also going to talk about screening 

6 materials based on rigidity and a proposal to test or 

7 exclude materials based on composition. So we're to talk a 

8 little bit about that. 

9 The second proposal that we had beyond the 

10 accessibility was ASTM's F963 currently contains a de 

11 minimis level. In other words, if you have a toy material 

12 that is less than 10 milligrams in mass, the standard 

13 doesn't require testing. And so what we would like to see 

14 is at least some investigation into the idea of adopting 

15 that 10 milligram de minimis level for the lead requirements 

16 in both surface coatings and in substrates.

17 We currently don't have the data, but we are 

18 collecting them. The one thing that we did have, the staff 

19 did some excellent work a couple of years ago and determined 

20 that a lead exposure of less than 2.2 micrograms per day --

21 and that's an exposure level, not a content level -- would 

22 not result in a measurable increase in blood lead level, 
124

1 which is the gold standard that H.R. 2715 put in place. But 

2 it used an assumption of 50 percent absorption of any 

3 ingested lead. And what we are finding from our ASTM 

4 soluble testing is that absorption may be much less than 50 

5 percent. In fact, it may be much less than one percent. So 

6 we are still collecting data and we'll be proposing --

7 making a final proposal -- at a future date.

8 And proposal number 3 is to exclude some materials 

9 from lead and heavy elements testing based on their 

10 composition. And we're talking here -- I want to be clear. 

11 We're talking here about natural or neat resins. We don't 

12 have the confidence that all colorants -- for instance, once 

13 they’re added to the material -- wouldn't create a potential 

14 issue. What we are talking about, those manufacturers who 

15 are using component part testing who currently are testing 

16 the resin. They're testing the colorant. They're testing 

17 any other additives that they might be putting into the mix. 

18 So we'd at least like to give them the relief on 

19 the materials, the resins themselves that contain nothing 

20 else except the plastic that they don't contain lead or 

21 heavy elements. And then composite wood, for the reasons 

22 that you've heard, I won't go into all the details, since 
125

1 it's been covered very adequately by some of my fellow 

2 panelists. Composite wood is unlikely to contain 

3 significant lead or heavy metals. And then, again, we're 

4 still collecting data and we'll make a final proposal at a 

5 future date. 

6 The materials for which data gaps exist, PVC, 

7 while most PVC suppliers have switched, there were heat 

8 stabilizers that were based on lead or cadmium or barium. 

9 Most of the PVC suppliers for the children's market have 

10 switched. Most of the stabilizers these days are based on 

11 calcium or zinc, or a combination. The same for 

12 polyvinylidene chloride and chlorinated PVC, neither of 

13 which is used commonly in toys.

14 PVDC, occasionally you'll see it in things like 

15 doll hair. But chlorinated PVC is almost never used. And 

16 then thermoplastic polyesters, PETE, we're still collecting 

17 data. We have a concern about the fact that antimony tri18 oxide is sometimes used as a catalyst in producing that 

19 material. Now, while we're not using it in the soluble 

20 test, we want to make sure that we've got the data before we 

21 make that proposal to the Commission. 

22 Again, why some materials don't require a 
126

1 certification testing, most plastic materials that we've 

2 listed are, again, they use petroleum or natural gases of 

3 feed stock, which typically don't contain high levels of the 

4 regulated metals. Polylactic acid, again, coming out of 

5 cornstarch, unlikely that the heavy metals would find their 

6 way in there. And then, again, resin producers tightly 

7 control the extraneous materials to make sure that they're 

8 producing the quality that's necessary, particularly when 

9 you are reacting these materials and you're polymerizing 

10 them. 

11 Keep in mind that in many cases the polymerization 

12 process is using a platinum or palladium catalyst. So 

13 particularly for the case of lead, that would tend to poison 

14 the catalyst. So for that reason alone, you would want to 

15 be very, very careful about making sure you don't have any 

16 lead in the process. And then, again, composite wood 

17 contains only trace levels due to wood, itself, and it's 

18 already exempted from lead testing by 16 C.F.R. 1500.91. 

19 Our experience is most of the resin systems used in 

20 manufactured wood are as you've heard urea formaldehyde or 

21 melamine formaldehyde based. 

22 So formaldehyde is an issue, both from the 
127

1 standpoint of the CARB ATCM and the pending EPA regulations. 

2 But we're certainly not seeing heavy metals there. So, by 

3 test, it's been absent. And, again, materials which should 

4 not -- and again we're talking about natural resin, no 

5 colorant, just the resin as it comes out of the bag. 

6 There's a list of materials here which we'd like to propose 

7 to be exempt. 

8 Testing for lead and heavy elements, in some cases 

9 for years, and Hailey's going to talk about this in a 

10 minute. She's a manufacturer based here in the U.S., and 

11 she's done extensive testing. We're just not finding these 

12 things. They're not in many plastic materials. They're not 

13 in composite or manufactured wood materials. And these data 

14 in combination with knowledge of the material and the 

15 process, we believe, give us adequate assurance that you're 

16 not going to find these trace metals in these materials.

17 And I'd like to directly answer one of Kris's 

18 questions, which is can we make some assumptions about 

19 solubility of materials based on how much is there in terms 

20 of total amount. And I would say other than to say that the 

21 soluble amount is going to be no greater than the total 

22 amount, I don't know that we can say anything. And the 
128

1 issue is that it depends so much on the matrix in which it's 

2 distributed; and, it depends so much on the individual 

3 species that we're dealing with. 

4 For instance, a good example is barium sulfate is 

5 very commonly used as a paint pigment. It's very commonly 

6 used as a plastic pigment. It's used on paper; however, 

7 it's virtually insoluble. And so, in fact, it's used in 

8 medical contrast studies. They feed you a barium malt so 

9 they can get a better X-ray view and it passes through the 

10 system without being absorbed. On the other hand, other 

11 barium salts might be very different in terms of their 

12 solubility. So I don't think we can come to any 

13 conclusions, or at least not based on the data we have. 

14 Accessibility in summary, accessibility 

15 determinations we think we should better reflect the hazard 

16 than they do today; and certain materials, we think, may 

17 require continued testing, and we're continuing to gather 

18 data. We think other materials should be exempt, based on 

19 their composition. And, again, we're not seeking relief 

20 from compliance. We're seeking relief from what we think is 

21 unwarranted testing that doesn't get us anywhere. And I 

22 guess that brings me to a question I have for the staff, and 
129

1 I'll kind of kick it off here. 

2 When we talk about a high degree of assurance, 

3 what level of assurance are we looking for? And maybe we 

4 can talk about that as we field questions. Thank you.

5 [Applause.]

6 MS. ADAIR: Thank you so much, Al.

7 I'm going to welcome Hailey Mann from American 

8 Plastic Toys. 

9 [Slide presentation.]

10 MS. MANN: Hi, everybody. I'm Hailey Mann. I'm 

11 responsible for quality, engineering, product safety and 

12 compliance for American Plastic Toys. Again, I'd like to 

13 thank the Commission and the staff for the opportunity to 

14 participate on the panel today, and I just want to give a 

15 brief history of American Plastic Toys.

16 We are a domestic manufacture of injection molded 

17 plastic toys. The company was founded in 1962 and has 

18 operated continuously for over 50 years. Our corporate 

19 headquarters are located in Walled Lake, Michigan. We 

20 currently have five buildings with over a million square 

21 feet of assembly, manufacturing and storage space, and all 

22 of our products are produced and shipped from either our 
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1 Michigan facilities or our Olive Branch, Mississippi 

2 facility. 

3 We're a vertically integrated manufacturer. We 

4 take in raw plastic and colorants, and mold and assemble the 

5 finished product. We have over 50 injection molding 

6 machines, corporate wide, and they vary in sizes from 150 

7 tons up to 946 tons. And we have just over 300 employees. 

8 We do have the most comprehensive product line of injection 

9 molded toys in the United States. We currently have 

10 approximately 125 items in our product line. I brought a 

11 little example. They range from a small sand shape, which 

12 retails for about a dollar, to a large plastic playhouse 

13 that retails for over a hundred dollars. 

14 What I'm here to talk about today is to present 

15 data for two materials used in our manufacturing process: 

16 natural, unpigmented polypropylene and polyethylene resins. 

17 These two materials will not contain any of the eight 

18 elements at detectable levels. I have a data packet that 

19 contains results I've compiled over the last 15 months. I 

20 have tested 105 different lots of natural resin that total 

21 represent 20 million pounds of polypropylene and 

22 polyethylene. I'd like to highlight in every case the test 
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1 results for the 8 ASTM elements, and these resins confirm 

2 these plastics are not just compliant, but the element 

3 content is so low or non-existent as to be undetectable. 

4 Here is one example of the supporting test results 

5 included in my data packet. I've highlighted the results 

6 section, showing that all 8 elements are below detectable 

7 levels. The test results demonstrate a high degree of 

8 assurance that these two materials, polypropylene and 

9 polyethylene, will not have any of the 8 elements at 

10 detectible levels. The technical considerations, as Al 

11 already pointed out that polyethylene and polypropylene are 

12 produced from petroleum or natural gas, which do not contain 

13 appreciable amounts of the regulated metals. These gases 

14 are polymerized in a reactor in a closed process, which 

15 eliminates contamination opportunities. 

16 The resin producers are careful to control the 

17 presence of trade metals, as they will interfere with the 

18 ability to obtain desired properties in the finished

19 plastics. Polypropylene and polyethylene, natural raw 

20 resin, should be excluded by regulation based on the test 

21 data submitted. We, as a manufacturer, know what goes into 

22 our products. Excluding polypropylene and polyethylene 
132

1 resin will produce an annual savings of $30,000 for American 

2 Plastic Toys. This is a significant percentage of our 

3 overall testing expenditure. We're considered to be a small 

4 manufacturer, and a $30,000 savings annually can be put 

5 towards new product development or hiring manufacturing 

6 employees.

7 Resin manufacturing is a technical and controlled 

8 process. Resin is tested and certified throughout the 

9 public manufacturing process, and we received material 

10 certificates with each shipment of raw, natural resin. 

11 Manufacturing, safe quality and fun products is our top 

12 priority as an industry. Having quality systems placed 

13 throughout our manufacturing process for periodic testing 

14 and inspection gives us assurance that our products are 

15 compliant. 

16 Eliminating the need to test materials that do not 

17 have detectable levels of the 8 elements is a great way to 

18 reduce third-party testing costs without compromising safety 

19 and compliance. That's all I have today.

20 [Applause.]

21 MS. ADAIR: Hailey, thank you so much. That's 

22 very good information.
133

1 MS. MANN: Thank you.

2 MS. ADAIR: Again, welcome Dr. Sanjeev Gandhi to 

3 the podium. 

4 DR. GANDHI: Hi. I'm Sanjeev Gandhi, deputy VP 

5 and technical director for SGS, North America. I want to 

6 thank again the Commission, the Commissioners, for the 

7 opportunity to be here. For this afternoon's session, I did 

8 not have any prepared slides to show. I just wanted to make 

9 a few comments. And, given some of the assertions that were 

10 made by previous panelists, I just want to echo my 

11 concurrence with some of the conclusions that they have 

12 drawn, especially with respect to lead in case of natural 

13 wood and as well as composite wood materials. 

14 So, and even some of the glue systems that we have 

15 looked at, they have consistently shown now to be either 

16 showing no detectable level of lead, or very, very low 

17 level, and maybe lower than thresholds that are in the 

18 standard. So I just want to also provide a clarification to 

19 the requirement -- I think, Nikki, you mentioned -- about 

20 certain low formaldehyde, urea formaldehyde resin systems 

21 are non-urea formaldehyde based resin systems that are 

22 grandfathered in under the CARB scheme, which is also part 
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1 of the basis for the EPA's regulation, although they have 

2 not yet come into effect. 

3 So those certifications, based on the usage of the 

4 low formaldehyde level, are non-formaldehyde based resin 

5 systems. Those are subject to a certification scheme, which 

6 is through a traceability requirement, but there is also a 

7 validation step that is built into it through a data packet 

8 that the manufacturer has to provide, that indeed the resin 

9 system used is off that type. And that data packet is in 

10 the form of testing that is done, either in-house, because 

11 that's acceptable, or through a third-party. So I just 

12 wanted to issue that clarification, that certification for 

13 the traceability of the formaldehyde resin system or non14 formaldehyde-based resin system to be grandfathered in, 

15 there is a requirement of validation built into the 

16 regulation, as well. 

17 Thank you. That's all I wanted to say for now. I 

18 will take questions as we proceed further. Thank you.

19 [Applause.]

20 MS. ADAIR: Thank you to all the panelists, and 

21 this is the time to ask questions. As we did before, if you 

22 have a question, if we have questions from the audience, you 
135

1 need to come up to the lectern, speak into the microphone. 

2 State your name first and then your question, and as well 

3 for the panelists and staff. You want to make sure you use 

4 the microphone so we get everything on the webcast and for 

5 the transcript. So I'll ask first from the audience, does 

6 anyone have a -- would like to start us off with a question. 

7 Great. State your name.

8 DISCUSSION

9 MR. UHL: I think everybody knows me. I'm Rick 

10 Uhl with CPSC. I'm just going to start off with a real 

11 simple question. Then I'll go sit down until I think of 

12 another one. 

13 Hailey, I'm curious with the resins that you test, 

14 if you can divulge it. I'm interested in the sources of 

15 those resins. You know. Is it a lot of different 

16 manufacturers? Is it overseas? Domestic? You know. If 

17 you can give that information, I'd be interested to hear it. 

18 Thank you.

19 MS. MANN: Sure. So with each test report that I 

20 submitted, I put in the material certificate from the person 

21 that we purchased the material from. We do purchase from 

22 distributors. So that material, essentially, could come in 
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1 from overseas, or it could have been manufactured 

2 domestically. So we really don't know. I can say 100 

3 percent, unless the distributor were to give me a definitive 

4 answer for where they purchased the plastic. However, like 

5 I said, I did submit the material certificate coming from 

6 the distributor based on what they're told the material is 

7 to be from whoever they purchase the material from. 

8 DR. RECHT: I have a question, I guess, maybe for 

9 Nikki, but for all of -- well at least maybe the right half 

10 of the table that had the wood experience -- on my right, 

11 that is. I'm wondering. I know some woods can be 

12 composited with plastics. There's decking. I have trim on 

13 my house with PVC and wood composited together. Are there 

14 terms of art to distinguish that from MDF and particle board 

15 and plywood? But also, are there instances where plywood or 

16 MDF, or some things that as you would define them might 

17 somewhere in the world be pigmented or have polymer 

18 additives as well as the glue systems? 

19 DR. BROWN: I can take a stab at that, and anybody 

20 else, feel free to jump in. So some of the decking 

21 materials certainly are pigmented. You can see different 

22 options that are available, you know, when you go to a home 
137

1 supply company. And it's certainly plausible to have 

2 different chemistries that have been done or that are 

3 applied to wood particles, or actually the resin itself can 

4 be modified slightly with anhydride functionality to improve 

5 the coupling between the wood particles and the plastic. 

6 So those would be my two comments that, yes, 

7 pigmentation is possible. And then, secondly, there are 

8 some functionalities, but those typically would not -- the 

9 pigments may contain some of these elements of concern, but 

10 the functionality coupling chemistries that I'm aware of are 

11 anhydride based and don't contain any heavy metals.

12 MR. PERDUE: Joel, just to answer your question 

13 from the furniture industry's perspective, we do not use 

14 that blended product in component parts for finished goods. 

15 So we don't use that. That's not typical of what we do, nor 

16 would we find that in any of our product offerings. It's 

17 strictly -- it's going to be wood-based; and, again, as I 

18 indicated in my presentation, the system is pretty closed. 

19 So we're not recycling plastics in our process to make these 

20 wood mats that we turn into MDF and particle board that are 

21 used as component parts for furniture.

22 MR. KAUFMAN: Yeah. If I could add something, I 
138

1 would say that I'm assuming what you're talking about is 

2 something like Trex decking. That is not, you know, by 

3 definition, a composite wood product. It's really a plastic 

4 product that's been loaded with wood fibers to give it the 

5 appearance of wood; but, it's really high density 

6 polyethylene. It's a molded plastic product. So when we're 

7 talking about wood here and when we say composite wood, 

8 we're talking about something that's a hundred percent wood, 

9 basically glued together into a whole. 

10 And I would say that, certainly, if there is any 

11 pigmentation, if there are any coatings, those would be 

12 outside the scope of what we're looking for. We're talking 

13 about just the composite wood itself: Masonite, particle 

14 board. What are some of the others -- plywood, et cetera, 

15 MDF, so.

16 DR. BROWN: If I could clarify, that's a great 

17 point. So typical resin loadings and traditional wood 

18 composites are up to 10, 12 percent resin content. The 

19 plastic decking components are an entirely different class 

20 of -- we call them composites, academically, but they're 

21 not. They're traditional wood-based composite; they're a 

22 plastic that's heavily filled with wood particles. And, in 
139

1 that case, it may be much higher loadings of -- it would be 

2 certainly much, much higher loadings of plastic that's 

3 filled with wood particle. So a very good point, Al.

4 MR. PERDUE: And I think we need to keep that 

5 distinction that we're talking about two, different product 

6 categories and product types. What we're typically using is 

7 wood, not plastic. And if there is a clear definition that 

8 defines those type of products that are used, yes, but 

9 they're not typically -- to use Randy's term, they are never 

10 used in the wood furniture industry to a high degree of 

11 assurance.

12 DR. HATLELID: I'd like to ask a question that 

13 maybe we're not going to get the answer to directly. But, 

14 so, I heard some technical information from Nikki and Bill, 

15 and everybody else, and in general terms, the formaldehyde 

16 resins and the other types of things. And I'm wondering if 

17 there are written resources that detail the chemistries of 

18 these, including catalysis steps, the catalysts used. I 

19 mean I guess I realize some things are going to be 

20 proprietary at some point, but, so that we can understand. 

21 To hear that a product is just glue and resin kind of makes 

22 us go, okay, we don't know what those things are. So if 
140

1 there are written, detailed descriptions of some of those 

2 common chemistries, that would, I think, fill in our 

3 knowledge gaps on what really goes on.

4 MR. PERDUE: Kris, that's a great point, and yes. 

5 I'm sure. Absent in this panel discussion are the resin 

6 suppliers and the resin manufacturers, and I'm sure that 

7 they can provide that type of information to us about how 

8 the resins are constructed and put together, and just 

9 exactly what makes those resins up and why lead wouldn't be 

10 part of a catalyst system that would be used, again, 

11 typically in wood furniture. So, yeah. I believe we could 

12 get that information to you. 

13 MR. KAUFMAN: Yeah. And absolutely, we'll see if 

14 we can get you some information; but, in general, what's 

15 going on is you're putting precursors in between layers of 

16 wood, and you're using heat or steam to essentially drive an 

17 irreversible reaction. It's a thermoset plastic. So you're 

18 really in the same way that you're using a urea formaldehyde 

19 resin to glue these together, it would be very similar to, 

20 let's say, a melamine ball once you've driven that thermoset 

21 process forward. 

22 DR. BROWN: There's also information, the 
141

1 published literature about the mechanism of formaldehyde 

2 based resins that I can provide. There's been textbooks on 

3 wood adhesives technology. So the information is also in 

4 the technical literature. But, primarily, the catalysis 

5 mechanism for the formaldehyde based resins is PH driven, so 

6 it's either acidic-cure or base-cure, depending on the type 

7 of resin that you're looking at. So, again, it's not a 

8 traditional -- metal-base catalysis is not used in the 

9 formaldehyde systems, and isocyanate currently is frequently 

10 not catalyzed at this point, although they're trying to push 

11 the speeds for iso. So it may be in the future catalyzed.

12 MR. PERDUE: And just to speak to the di13 isocyanate issue, typically, again in our industry we don't 

14 use di-isocyanate. Typically, it's very slow as Dr. Brown 

15 pointed out. So it's something that we don't use quite a 

16 bit. So --

17 DR. RECHT: Just on the topic of the references in 

18 addition to providing the academic references that you just 

19 mentioned, which would be very helpful, you mentioned at the 

20 start of your talk that you had found some sources of 

21 information about the 8 elements in natural wood -- not 

22 composite. If you could share those references with us as 
142

1 well, that would be most helpful.

2 MR. BUTTURINI: And I want to emphasize that Bill 

3 said exactly the right thing, and not for the first time. 

4 Let me point that out. He said exactly the right thing, 

5 that with composite woods, the wood's been taken care of 

6 with regards to lead content. And what the Commission is 

7 interested in knowing is about the resins. And the magic 

8 word here is because there won't be lead or there won't be 

9 other elements in resin, because of this or because of that. 

10 And there's this knowledge available about all the 

11 manufacturers of resins that are used in manufactured woods 

12 -- and I'd back up one step -- and that manufactured woods 

13 use resins that could be called adhesives, and phthalates 

14 are sometimes used in adhesives. 

15 And if there's a way to make that loop close, that 

16 the prohibited phthalates can't be used, won't be used for 

17 reasons, A, B, C in manufactured woods, then that would open 

18 up a possibility for making a determination for toys, for 

19 example, that are made with manufactured woods being 

20 compliant with the phthalates limits. 

21 Mr. Perdue: Say, Randy, you bring up a good 

22 point. And one of the notes that I made, specifically about 
143

1 phthalates when we were talking about this before the 

2 session, was looking at the resin systems and trying to 

3 determine within that system what phthalates are present and 

4 why. Yes, it is an adhesive, it's in the family of 

5 adhesives. So, typically, the assumption would be that 

6 there is some, I guess, congener of a phthalate present 

7 within the resin system. But that's something we'd have to 

8 take a very hard look at to determine what's actually there.

9 But, again, the focus of what we're talking about 

10 today is lead and a determination for lead for composite 

11 wood products. And I want to make that very clear, that 

12 what we're asking for, while the phthalate is an ancillary

13 issue that needs to be addressed -- and I understand that --

14 the focus right now is on a determination for composite wood 

15 products and lead, and not have to test for lead. 

16 MR. KAUFMAN: Yeah. And the only thing I would 

17 add to that is you're absolutely right, Randy, that 

18 phthalates are occasionally used in adhesives; but, 

19 typically, they're either hot melt or polyvinyl acetate20 based adhesives. The types of thermoset resins we're 

21 talking about here do not contain phthalates; and, in fact, 

22 if you look at the data that I presented, we have 4800 cases 
144

1 of where we've tested wood products and not found 

2 phthalates, any of the restricted phthalates. 

3 DR. BROWN: Yeah. I'd just like to echo that. 

4 When you think about the chemistry and what we're trying to 

5 accomplish when we make composites from wood, there's just 

6 no need to add a plasticizer. Wood, itself, the mechanical 

7 properties give you what you need, so there's no need to 

8 soften. So, again, why would you add cost, add a 

9 contaminant to the system? So the traditional resin 

10 chemistries used in composites are not going to contain 

11 phthalates, but the polyvinyl acetates and the ethylene 

12 vinyl acetate systems for hot melt or for solid wood 

13 components glued together could and do contain phthalates.

14 MR. PERDUE: And, just, if I may follow up on 

15 that, that's a process of the manufacturing process. And so 

16 when we're making the mat and we're making a composite wood 

17 product, typically MDF or particle board, we're not using a 

18 PDA type resin system when we make the mat, because we're 

19 using heat and steam in order to kick that over. And so 

20 those, typically, are not phthalates, typically are not 

21 found in that resin system for making the mat. So it really 

22 is a function of the process, and I think that needs to be 
145

1 also distinguished in this conversation. 

2 MS. ADAIR: Questions from the audience?

3 MR. UHL: Yes, it's me again, Rick Uhl, CPSC. 

4 Kris alluded to this earlier. But when we think about the 

5 ASTM F963 and the 8 elements in terms of solubility, and we 

6 start thinking about determinations, there's two roads that 

7 we can look at. One is if the content of any of those 

8 elements or all those elements is less than the solubility 

9 limit, then you're in, right, if you can prove that the 

10 content is always lower than the solubility requirement.

11 Then there's the second option, which is, okay, 

12 the amount or the content might exceed the solubility limit, 

13 but it will never extract in the hydrochloric acid test 

14 method. We've talked about wood and we've talked about 

15 plastics. I'm curious. Are there any other materials that 

16 come to mind as we're having this discussion beyond wood and 

17 resins? Thank you.

18 MR. KAUFMAN: That's a good question, Rick. I 

19 would say certainly you could apply at least the solubility 

20 question to coatings, surface coatings and potentially to 

21 adhesives and other materials. The issue is that if you're 

22 simply testing the product without knowing what went into 
146

1 it, it would be very difficult to do that, because you don't 

2 know exactly what species or exactly what matrix you're 

3 dealing with. 

4 If, for instance, you are the manufacturer and you 

5 know that you've put in a certain amount of a very specific 

6 species of lead, let's say, just for sake of argument, it 

7 would be relatively easy to use textbook data to determine 

8 what the likely solubility is of that material. Lead's not 

9 a good example there, because you've got a total limit 

10 anyway, but, let's say, chromium. So, you know, if you for 

11 some reason had intentionally had chromium, and you knew 

12 what chromium species you were dealing with, you could 

13 potentially do that, but, you would have to know what that 

14 material was. And a good example would be, you know, let's 

15 say -- well, barium sulfate is the example that keeps coming 

16 to mind. I mean you could load barium sulfate in there all 

17 day, and it's never going to be soluble. On the other hand, 

18 you might very well put another barium salt in there that's 

19 much more soluble, and you would have to be very careful and 

20 then know exactly what you're putting in there. 

21 MS. ADAIR: More questions from staff or from the 

22 audience? Okay, Randy.
147

1 MR. BUTTURINI: I just want to make sense. Randy 

2 Butturini, CPSC. I just want to make clear what I'm hearing 

3 so I understand it. So it's sort of a question. Then I 

4 have another question, which is more difficult to answer. 

5 When you're talking about resins, plastic resins, natural --

6 well natural plastic resins, right, before the colorants, 

7 before the processing. What you're saying is -- and this is 

8 what I'm asking about. 

9 Is what you're saying because these things are 

10 made in a very pure fashion, there's very little chance that 

11 extraneous materials -- some of which could be lead, some of 

12 which could be the 8 elements -- are very unlikely to 

13 appear? And that sounds very interesting. We'd be 

14 interested in knowing about all the other ways to make and 

15 all the other people making these types of resins. Because 

16 if everyone uses a pure process, for example, if there's so 

17 much market competition that anybody that does something in 

18 an uncontrolled fashion has difficulty getting customers, 

19 something. You know, something, again, to answer the 

20 question because, or to say always. It's always this way 

21 for these reasons -- you know -- A, B, C, and it's going to 

22 be that way for everyone, because of these reasons. 
148

1 The reasons could be, you know, economic, process 

2 control, volume. You can't make it poorly and get very 

3 much. I mean whatever it turns out to be, that's the kind 

4 of information we're interested in. 

5 MR. KAUFMAN: This is Al Kaufman again. That sort 

6 of brings us back to my initial question, which was if the 

7 bar that we have to get over is always to have a high degree 

8 of assurance, that's going to be very difficult. I think we 

9 can certainly get it to the point where you say it's highly 

10 unlikely, in fact, very highly unlikely; but, I don't think 

11 we can ever prove never. 

12 MR. BUTTURINI: You're right, Al, that a high 

13 degree of assurance does not mean never. And it 

14 intentionally does not mean certainly, you know. There's 

15 certainty, and then there's a high degree of assurance, and 

16 there's a difference between those two, because we know that 

17 some information is just not obtainable in one sense. That 

18 would be one question I could pose, if we're talking about 

19 getting this sort of information to make a determination. 

20 What can't we get? And that would be interesting to know, 

21 because if we can't get it, then let's stop asking for it, 

22 that sort of thing that can go on. But in 16 C.F.R. 1107 is 
149

1 the definition of a high degree of assurance.

2 MS. MANN: And I just would like to state that 

3 besides the way that the natural resin is manufactured, the 

4 data speaks for itself. I mean I've compiled that data over 

5 the last 15 months, and every, single test result that came 

6 back was not detected for almost 20 million pounds of resin. 

7 And that's just to us that, you know, purchase 20 million 

8 pounds of resin over the last 15 months, and we're a small 

9 company. And that type of impact, for me, shows that I am 

10 testing something that's unnecessary from our standpoint and 

11 doesn't improve safety of the product. 

12 MR. KAUFMAN: Well, and also when we're talking 

13 about plastics, polymerization processes, keep in mind --

14 and I talked about it a little bit in my presentation -- not 

15 only is there no reason to put it in there, but there is a 

16 very strong incentive for the manufacturer to keep it out of 

17 there, because, as I said, some of those trace elements can 

18 poison the catalyst and keep the polymerization process from 

19 going forward. And you just end up with this mess in the 

20 bottom of the reactor that you have to go in and chip out 

21 with an air gun. So, I mean there's a very strong incentive 

22 to keep that process going. 
150

1 DR. RECHT: I have a question for Sanjeev. You 

2 showed some data in the phthalates presentation about 

3 different kinds of materials and where you found phthalates. 

4 I wonder, again, getting back to the idea of are there some 

5 other materials, even beyond the wood and the plastic resins 

6 -- where you have data about the 8 elements collectively 

7 never extracting out above the levels -- because the matrix 

8 of the material doesn't let them out, even when they're 

9 there, or because they're the level that they're present and 

10 that kind of a thing. 

11 DR. GANDHI: Thank you. One of the reasons that I 

12 did not have that data to share with the audience today is 

13 that the data that I'm in the process of examining right now 

14 and further analyzing, you know, is yet not granular enough 

15 for me to say between the different type of materials -- you 

16 know -- if at a sub-grouping level, what are the high risk, 

17 low risk, medium risk. So that kind of granularity is not 

18 there. You know, composite wood is bisulfate category, and 

19 therefore I was happy to make a categorical announcement, if 

20 you will, based on our examination of that data. You know. 

21 We don't see a phenol rate associated with lead. 

22 Now, going to the other elements, that is 
151

1 something I still need to look at. We have recently 

2 undertaken a study at SGS looking with expansion of, well, 

3 for U.S.'s 8 heavy metals, for Europe we have 19 heavy 

4 metals. And so we end up processing and analyzing a large 

5 set of data that takes into account different types of 

6 substrates for all those 19 different heavy metals. 

7 So, like I said, I'm still not far enough in my 

8 analysis to present that finding with the Commission. There 

9 are still some questions I have that I haven't answered for 

10 myself, and I need the assistance of my team overseas. So 

11 that's why I did not feel comfortable bringing that to the 

12 table here, but I'll be happy to share that in the future. 

13 DR. RECHT: Thank you.

14 DR. GANDHI: We are, you know, looking for the 

15 kind of data I brought last time. So I didn't feel 

16 comfortable I had that high degree of assurance that I could 

17 speak to that data.

18 MR. KAUFMAN: And, excuse me a second, if I could 

19 just add onto that. I would say that certainly, at this 

20 point, from our viewpoint, we have enough data based on test 

21 data, based on what we know about process, based on all of 

22 the work that Hailey has done that, certainly, at least 
152

1 polyolefins could be put in an exempt category. And we 

2 believe that that list will get a lot longer, but we're 

3 still gathering data.

4 DR. RECHT: In that case, are you referring to the 

5 resins, again, as opposed to the colored, finished product?

6 MR. KAUFMAN: Yes, absolutely. In other words, as 

7 I said, we don't have the confidence that you will, for all 

8 colorants. We know a lot of them don't contain these 

9 materials; but, we can't say with certainty that all of them 

10 don't. 

11 DR. HATLELID: I'd like to follow up a little bit 

12 on the resins issue. So tell me if it's the case when one 

13 makes an order for its natural resins that you have to 

14 specify things like the low metal kind, or that doesn't 

15 exist. You're shaking your head. And to follow-up on that, 

16 is the situation with these products or these materials now 

17 any different now that we have requirements for some of 

18 these elements, at least for the children's products, to 10 

19 years ago? Or is there a difference in manufacturing or the 

20 supplies? 

21 MR. KAUFMAN: That's a couple of questions, 

22 actually. And I'll start with the second one first, which 
153

1 is yeah, there have been changes made with respect to some 

2 materials, as I mentioned, PVC. It used to be reasonably 

3 common to run into PVC with lead or cadmium stabilizers. We 

4 almost never see that anymore. As I said, almost 

5 everybody's gone to calcium zinc. For other materials, they 

6 typically didn't contain them to start with, and so there 

7 haven't been any changes. And that's one of our issues is 

8 we're testing repetitively to find out something that we 

9 know was never there and still isn't there. Does that 

10 answer your question? 

11 MS. ADAIR: More questions? Questions from the 

12 audience? Randy.

13 MR. BUTTURINI: I'll ask my second question now, 

14 and this is both for, let's say, the plastic resins and the 

15 manufactured woods. We have a procedure, 1500.89, 16 C.F.R. 

16 1500.89, to request a determination for lead. Have you ever 

17 considered using that procedure to make a request for 

18 manufactured woods? Did something get into the way, you 

19 know, to keep you from doing that? Was there some part of 

20 it that you didn't think you could do? Or is there anything 

21 intrinsic in that that kept you from following through with 

22 actually making a request using that procedure?
154

1 MR. PERDUE: Randy, yes. The answer to that 

2 question, we did consider making a determination with 

3 composite wood products. As a matter of fact, we were 

4 working with the Composite Panel Association to do so, very 

5 early on. We sent in a letter. CPA sent in a letter, and 

6 basically it was rejected at that time. We came back and 

7 started talking to staff about, okay, what do we need to do? 

8 How do we make this determination? What do you require from 

9 us? We were given a pretty detailed laundry list. 

10 We went away, put that laundry list together, sat 

11 down with staff again. And, Randy, with all due respect you 

12 have a great staff and I really enjoy working with all of 

13 them. But it seemed as if we were just chasing a ghost in 

14 the dark, and we never could get to this level of assurance. 

15 You know. Where did we stop trying to figure out is this 

16 there, are you assured, is there certainty? And we just 

17 backed away. We got to the point where we were putting a 

18 lot of time and effort and resource in developing this 

19 determination, and just simply felt we could never get to 

20 the end point. 

21 MR. KAUFMAN: And just to add to that, correct me 

22 if I'm wrong, but my understanding of the procedure in 
155

1 1500.89 is something which is intended to provide an 

2 exemption on a very narrow basis. In fact, one example that 

3 comes to mind is aluminum castings in a ride-on toy, so that 

4 what we're looking for is broader or more general 

5 exemptions. We're not looking to have a specific grade of 

6 polyethylene exempted. We're looking for all polyethylene 

7 to be exempted. 

8 DR. HATLELID: So I want to clarify that. There 

9 are two types of issues we're dealing with for the lead 

10 requirements, and one of them is the determinations --

11 things that do not contain the lead and then don't undergo 

12 the third-party testing. That's the procedures at .89. 

13 There used to be procedures at .90, and those have been 

14 withdrawn.

15 That had to do with statutory exception process, 

16 which changed in 2011 for things that do contain lead, such 

17 as the cast aluminum in that petition. So the 1500.89 is 

18 for the things that we have already for lead, like natural, 

19 untreated wood that we're talking about. Or, as you're 

20 talking about, the olefins that are intrinsically not lead 

21 containing. So there is that existing system, and it's to 

22 do exactly what we're talking about right now for lead. 
156

1 MR. KAUFMAN: Actually, as you were speaking, 

2 Kris, I realized I hadn't answered one of your earlier 

3 questions, if you'll permit me. You were asking about 

4 whether you needed to specify low metal content when you 

5 ordered. Typically, plastics are not made to order. 

6 Usually, you go to a resin supplier and they have a list of 

7 standard grades that you can choose from and usually select 

8 that grade based on the properties that you're looking for.

9 Does it have the tensile strength I need for this 

10 application? Does it have the impact strength? Does it 

11 have the melt flow index? Can I mold it in my equipment? 

12 Those sorts of things; and, in general, those specification 

13 for trace metals are the same across all of those grades. 

14 In other words, they're trying to keep those at absolute 

15 minimum levels, so. 

16 MS. ADAIR: Do we have any additional questions? 

17 We're getting towards the end of the session. We've got a 

18 few more minutes, though. If you've got questions, ask 

19 them. Ask away.

20 MR. BUTTURINI: I just want to make another 

21 clarification. Public Law 112-28 established another method 

22 to establish an alternative lead limit for something, and 
157

1 that was the petition submitted for the ride-on toy parts. 

2 So there are two ways to do this. One is a determination 

3 that lead is not there; the other is a determination of an 

4 alternative lead limit. So we're dealing with we have a 

5 couple of balls being thrown up in the air at this point. 

6 MR. KAUFMAN: Can I ask a question? How many have 

7 actually been granted at this point? 

8 DR. RECHT: One. 

9 MR. KAUFMAN: Yeah. So that would sort of speak 

10 to the difficulty of going that route.

11 DR. HATLELID: Well that was for the things that 

12 do have the lead, and the other route, it's --

13 [Microphone off.]

14 MS. ADAIR: Randy, do you have another question or 

15 a statement?

16 MR. BUTTURINI: Yeah. I just want to make one 

17 thing clear when we're talking about determinations. Test 

18 data is a wonderful thing, and test data might be considered 

19 necessary. But there's a chance that the test data won't be 

20 sufficient to make a determination. I keep waiving my arms 

21 and saying, you know, test data -- and Al has mentioned this 

22 in both of his presentations. Again, he said exactly the 
158

1 right thing. The test data, plus the knowledge about this, 

2 plus these conditions over here, plus the high incentives, 

3 plus the other sorts of things, that makes a body of 

4 knowledge that together could be considered as a whole to 

5 develop a high degree of assurance that does not and will 

6 not be non-compliant, can be achieved. So, a pile of test 

7 data is a very interesting thing. 

8 And of course the first question we'll ask is, 

9 this is great, what does this tell you about the things that 

10 haven't been tested? And it's the parts on either side of 

11 that that can extend the knowledge of the data information 

12 inside the test reports outside of that into the wider world 

13 of all the suppliers of this, all the users of this, all the 

14 chemical processes that do these sorts of things. And with 

15 that body of knowledge, then perhaps we can do something on 

16 that order. 

17 MR. MULLAN: Gib Mullan, CPSC. I wanted to follow 

18 up on that point, Randy, because another question that comes 

19 up a lot is when we get a bunch of data, it might be very 

20 informative, but it would be more informative if it would be 

21 accompanied by comments that help us understand is this all 

22 the data you had. Is this all the data for a period of 
159

1 time? Did you have any data that you didn't provide or that 

2 wasn't available? There are suspicious questions that can 

3 arise, and no matter how comfortable you are with the 

4 submitter of the data, it really helps to characterize the 

5 submission of the data. 

6 So, for example, Hailey, you described the data 

7 that you had, the test that you had done. And it sounded to 

8 me like from your description you had done tests on every 

9 batch you had received from every source for 18 months. 

10 If that is a universe of data from lots of 

11 different sources, and without any particular specifications 

12 trying to deal with the content of that, that's more 

13 meaningful to me, because it's a universe of data. Whereas, 

14 in some of the datasets that we received, they're just like 

15 whatever the person who's setting the data can get, and that 

16 might be only the good test results -- not to put too fine a 

17 point on that. So it's very helpful if you can characterize 

18 the data that you submit, and I think that fits with the 

19 theme here, too. Thank you.

20 MS. MANN: In the packet of data that I did 

21 submit, I did put a cover sheet in there explaining a little 

22 bit about the process for polymerization of the material. 
160

1 Like I said, there was a material search showing who the 

2 distributor was of the material. So you can see the range 

3 of material, and I only picked 15 months, ranging from two 

4 weeks ago for the past 15 months, because I didn't know how 

5 much data to bring. But I'm here. If you have any 

6 questions or you need more data from more suppliers, again, 

7 we only use polyethylene and polypropylene copolymers in our 

8 process. So that's the data I had and that's what's 

9 important to me as a company, because that will have the 

10 greatest impact to reduce our third-party testing. 

11 MR. MULLAN: So an example, what I'm talking 

12 about, Hailey, is you just mentioned you selected 15 months.

13 MS. MANN: No, that's everything.

14 MR. MULLAN: Okay. Well that's where I'm trying 

15 to get to is try to characterize, you know, that's 

16 everything, so that there's no concern that you in any way 

17 cherry-picked the data. That's the point that I'm trying to 

18 get out. Thank you. 

19 MS. ADAIR: More questions, Neal?

20 MR. COHEN: This is Neal Cohen, CPSC. This is 

21 kind of a general question related to Dr. Brown. You 

22 mentioned some of the studies that you found in Sweden and 
161

1 the rationale or the reason that there was an interest in 

2 Sweden in doing that testing. Is there -- besides this 

3 group here -- and many of us know each other for many years 

4 of these sorts of things. Is there an interest elsewhere in 

5 your academic community in these sorts of questions? And, 

6 if so, why and by whom? 

7 DR. BROWN: By "these sorts of questions," do you 

8 mean heavy metal content in wood?

9 MR. COHEN: Yeah, and solubility.

10 DR. BROWN: And solubility -- good question. From 

11 a fundamental point of view, I think there's always people 

12 interested in knowing more about how tree physiology --

13 phytoremediation issues, for example -- lead to fundamental 

14 changes in the material. But I would say it's probably a 

15 pretty small community. You know. It would be more 

16 relevant to practical groups like this. So I don't know if 

17 people -- other examples where those would be of tremendous 

18 interest.

19 MR. COHEN: Right. So, I guess, as you just said, 

20 sort of -- and it's a sort of applied scientific context --

21 there's a limited audience for it. You do -- I think you 

22 indicated you do research. And, if so, I'm not familiar 
162

1 with anything that you do.

2 DR. BROWN: Okay.

3 MR. COHEN: But, um -- you know.

4 [Laughter.]

5 DR. BROWN: Not many people are.

6 MR. COHEN: Well, and I think that's the point, 

7 like not many people are, and we're very pleased to have you 

8 here and bring your perspective here.

9 DR. BROWN: Sure.

10 MR. COHEN: So it's like what do you do, who funds 

11 what you do, who has an interest in funding what you do. 

12 DR. BROWN: Okay.

13 MR. COHEN: Do people move in and out of your 

14 position from industry to academia? Or what does an 

15 academic like yourself do and why, I guess. I think that 

16 would be interesting. 

17 DR. BROWN: Yeah.

18 MR. COHEN: I don't know if anyone else does, but 

19 if you would.

20 DR. BROWN: Sure. I'd be happy to comment on 

21 that. That was a lot of questions, but wood research used 

22 to be heavily funded by the USDA. There's been drastic 
163

1 funding cuts for our field, and wood is becoming grouped now 

2 with many more materials. So, for example, I was in a wood 

3 products unit at Penn State. Now, we've changed our focus 

4 to bio renewable systems. So we're not just focusing on 

5 wood. We're thinking about other bio-renewable materials 

6 and plastics. So the field, generally, is experiencing that 

7 change, and it's largely due to funding shifts from the 

8 government. 

9 We still do have to compete for funds from USDA, 

10 Department of Energy related to Bioenergy. To a very 

11 limited extent NSF funds our work, but a lot of the interest 

12 now is moving into bioenergy co-products to make the bio13 renewable platform viable, so developing different 

14 chemistries or materials from cellulosic compounds to green 

15 composites, how to make adhesives or coatings more 

16 environmentally friendly for wood and wood-based composites. 

17 These are the kinds of things that are more of interest to 

18 our community. 

19 MR. COHEN: Thank you. And this is going to be my 

20 last thought about it. But to those sorts of questions, the 

21 Swedish study was certainly focused on environmental impact 

22 upon humans through bio-renewables, basically. And we're 
164

1 talking to some degree about recycled content here, and 

2 other stuff about virgin or feed stock. But, so within that 

3 bio-renewable sphere, is there sort of like an EPA sort of 

4 emphasis on heavy metals or other human --

5 DR. BROWN: Yeah. That's a good question. So, in 

6 general, the impact of regulation has drastically changed in 

7 the last five years, especially focusing on the wood and 

8 wood utilization industry. For being a renewable producer, 

9 it's kind of been somewhat shocking. You know, the CARB

10 rule, big, big changes; and, again, that's becoming 

11 nationalized through the EPA Toxic Substances Control Act. 

12 So there've been a lot of interests on greening of adhesives 

13 chemistry. 

14 How do we develop resins that are less toxic -- I 

15 guess would be the right word. But on the other extent, 

16 yes, people are interested in issues like burning wood. You 

17 know. What do you do with all the CCA-treated wood that's 

18 going to be disposed of? I mean it's been 40-50 years. You 

19 look at all the houses in America that have decks, you know, 

20 built from 1970 to 2004. What are we going to do with all 

21 that wood that has all that chromium and arsenic in it? You 

22 know, big problems. So that's one thing -- remediation of 
165

1 those types of materials. 

2 EPA is looking at particulate emissions, or is 

3 going to be soon, from boilers. So even people who are 

4 trying to burn or recycle residue furnished from their mill, 

5 what kind of particulates are coming off. And then from dry 

6 kilns, there's increasing concerns now about methanol 

7 concentrations coming out off of dry kilns. So for wood 

8 being such a natural, renewable, sustainable material, you 

9 know, I think it's a great material. There's just tons of 

10 challenges now that professionals are having to think about 

11 and deal with. So I think that helps. 

12 DR. RECHT: I have another question for Nikki that 

13 reminded me. You spoke about the recycled woods in the 

14 biofuel example. Bill mentioned that his processes are very 

15 closed, that they make the board right next to their 

16 furniture facility. They take the waste from there and 

17 recycle it into the boards. That's not the only way that 

18 composite boards are made. I'm sure there are manufacturers 

19 making composite wood elsewhere. And I wonder to what, if 

20 any, extent are recycled wood products used. You know, 

21 maybe not in the furniture industry, but by and large, just 

22 commercial MDF board maker or particle board maker?
166

1 DR. BROWN: I'm glad you brought that up, Joel, 

2 because when Bill made the comments about reuse within the 

3 manufacturing plan, I just wanted to say, yeah, absolutely. 

4 The comment that I made about Sweden was dealing more with 

5 reclaiming municipal solid wastes, so materials that were 

6 coming out of renovation, sort of things like that, entering 

7 municipal solid waste and reclaiming those. 

8 That's an entirely different challenge than 

9 reusing what might be inside a closed, manufacturing 

10 facility. So I guess the in between, then, is what you were 

11 getting at Joel with. What about a plant makes MDF and then 

12 they ship it to somebody else off-site? And then what do 

13 they do with the waste that might be generated? 

14 DR. RECHT: Right. As an example, I used to work 

15 in the paper industry, so it's different, but not that 

16 different. And we made paper and we shipped it to whoever 

17 was going to print or make packaging from the paper. And, 

18 mostly, we made virgin paper, but we made paper with 

19 recycled content as well; and, in that case, we bought post 

20 consumer waste from the market and made paper from it. Is 

21 there some analogy to that in making wood with post consumer 

22 waste, composite wood products? 
167

1 DR. BROWN: Yeah. So feel free to comment, but in 

2 my experience, when it's resinated and compressed into 

3 composite, there's very limited options for reuse. So it's 

4 typically burned, boiler recover, if possible, if the 

5 chemistry allows that. Solid wood waste, however, from saw 

6 mills, can have a plethora of uses, like animal bedding, all 

7 kinds of use for particle board feed stock and other areas, 

8 as well as boiler feed. So I'll defer to others to comment.

9 MR. PERDUE: Just a couple points to clarify --

10 and splitting hairs here -- but we don't burn. We combust. 

11 This is a fuel stream. 

12 [Laughter.]

13 MR. PERDUE: It is not a waste, because it's not 

14 discarded under RCRA, so it is therefore a fuel. So we need 

15 to make sure what our terminology is here, because that's 

16 very important. And back to just looking at resonated off17 fall, which is what we're doing in our system, is taking a 

18 mat where we're using a resin system, a glue, to take wood 

19 particles that have been generated in the manufacturing 

20 process. We lay them in a mat. We put glue on them. We 

21 press them and use heat. We create particle board and MDF.

22 One of the things that you need to understand is 
168

1 there are two, very distinct mat standards that EPA has put 

2 together that regulate not only the drying of this wood, but 

3 the particle board and plywood mat really deals with sort of 

4 those intrinsic and internal emission requirements for the 

5 manufacture of a MDF, particle board and drying of lumber, 

6 and then the boiler mat. And what's really important about 

7 this -- to understand about resonated wood -- is that the 

8 non-hazardous solid waste rule, which is attached to the 

9 boiler rule, where we use, basically, some of the off-fall 

10 that we do not then turn into particle board, MDF board. We 

11 use it as a boiler fuel. It's a feed stock. 

12 Resinated wood is considered a fuel and not a 

13 waste. So it's really important to understand those 

14 distinctions. So we're not typically using post-consumer 

15 materials, such as creosote-treated railroad ties of that 

16 nature in what we're doing. Basically, what we're doing, it 

17 really is a system where we're making this board. Is there 

18 some wood that is post-consumer or that's purchased, like 

19 you did in the paper industry, that's added to the stock? 

20 Yes, it is, but that's a very controlled, natural wood 

21 fiber. It's not this post-consumer, building construction, 

22 railroad ties type of wood that's added into the mix. 
169

1 DR. RECHT: Just to follow up on that, because, 

2 again, that's getting closer -- right at the end of that --

3 to what I was getting at. I didn't mean to bring into your 

4 boiler operation, because I understand that fully well, too. 

5 But in the case -- again, just a board producer of MF board 

6 or particle board could, for instance. And is there any --

7 you know, we talked about the CCA treated wood, the existing 

8 stock in my back yard and many others of CCA wood. Is there 

9 any way that that could find its way into a recycling stream 

10 and to a manufacturer ground up and be used as a small 

11 component or at what fraction with virgin wood to make a

12 composite wood product?

13 MR. PERDUE: Just to speak to the industry, my 

14 industry, very little; basically, what we're doing is using 

15 wood or resonated wood would off fall from the process from 

16 the system. And that's kind of traded around between these 

17 companies that are making the mat for an MDF or for particle 

18 board. You know. You use the words would or could or 

19 possibly, again. You know, would or could or possibly, of 

20 course. However, typically, going back to Randy's 

21 discussion about defining "typically" within our industry, 

22 we don't do that. So I can state with some certainty that 
170

1 we're not bringing in this type of post consumer wood into 

2 what we're doing within our processes within our industry. 

3 MR. KAUFMAN: And remember that that CCA treated

4 wood is visually differentiable, very easily. It's that 

5 greenish color, because of the copper, and I just wanted to 

6 clarify, Joel. Was your question specifically about 

7 resonated, for instance, a composite wood products? Or was 

8 it about the Trex decking as well?

9 DR. RECHT: No. No, I meant for the composite 

10 wood products. You know. Is there a marketplace for post11 consumer, recycle content, composite wood products, like 

12 there's a market for people look to buy 10 percent recycled 

13 content paper as marker, 50 percent recycled content paper. 

14 There's various levels as a post-consumer recycle content. 

15 Again, not within the furnishings industry, but there are a 

16 couple of big companies like a Georgia Pacific or a 

17 Louisiana Pacific that makes lots of wood products. 

18 I don't know, you know, what they make. But as 

19 well as overseas, are there companies that make building 

20 materials that are composite wood building materials that 

21 use post-consumer waste? 

22 MR. KAUFMAN: And I guess the answer would be not 
171

1 to my knowledge. I couldn't swear that nobody's doing it, 

2 but I'm not aware of a market for it, not aware of a demand 

3 for it. And, frankly, if you think about the raw material 

4 for those composite wood products, someone who is an 

5 integrated wood supplier would certainly have enough 

6 generated from their own operations that they wouldn't need 

7 to look for post-consumer material.

8 DR. BROWN: I'd just say I agree with that. I'm 

9 not aware of any operations that are using vast quantities 

10 of that, and it's certainly not going to be the bigger 

11 manufacturers who are going to be doing that. I think a lot 

12 of concern could come up from the mom and pop shop that just 

13 is eking it out. And they find something laying on the side 

14 of the road and they want to -- the Amish, you know, mill 

15 wants to turn it into a product and sell it. 

16 And those are the kinds of operations personally 

17 that I'm more concerned about. I know that the big players 

18 in the industry are. They know the technology. They know 

19 what they're dealing with. They know how to make product 

20 and what not to make product out of. So that would be my 

21 comment.

22 MR. PERDUE: Joel, I think you hit the nail on the 
172

1 head. Is there a market for it and is there a demand for 

2 it? To my knowledge, based on what I know about my 

3 industry, no. There isn't, so. 

4 DR. GANDHI: I just want to mention as a side 

5 comment to that, I don't know about the wood industry, but 

6 for carpet for recycling, there's an incentive based on some 

7 state legislations and some are already in place. But some 

8 of them are in proposal stage that are trying to put that 

9 kind of marketplace infrastructure, if you will, for 

10 enhancing the recycling of carpets, and that kind of model 

11 that you're talking about. But I don't know anything that 

12 currently exists with respect to wood. 

13 MS. ADAIR: Another question from the audience?

14 DR. BROWN: I'd just like to make a comment while 

15 he's coming up. We talked a lot about CCA here today, and 

16 the pull on that was voluntary. So I just didn't want 

17 anybody to get the idea that that's a necessarily awful 

18 thing, that if you have it you need to get rid of it. 

19 There's a lot of contradictory literature about leaching of 

20 arsenic out of that material, and a lot of the scientific 

21 data suggests there's not a problem. So I just wanted to 

22 make that point. It was a voluntary pull by industry to 
173

1 remove CCA as a wood treatment compound, because the 

2 scientific literature was contradictory. 

3 MR. LEONARD: Hi. Chris Leonard, Modern Testing 

4 Services. As of late, we've been receiving in our 

5 laboratory a number of samples that have been submitted by 

6 Native American manufacturers. And my question is for Dr. 

7 Brown. You had mentioned that leaves, roots, branches, 

8 bark, typically have the highest, natural occurring levels 

9 of heavy metals. So it's a three-part question. So you 

10 also mentioned that this does vary by species of wood. 

11 Can you give us an example of what types of 

12 species from a high to a low range, where we may find those 

13 types of heavy metals? And do any of those species that the 

14 levels exceed the limits under F963-11? And, the third part 

15 is due to its rise in popularity -- and I don't know if this 

16 falls outside of this scope of your expertise -- has there 

17 been any evaluation, or is there any evaluations undergoing 

18 for bamboo? Thank you.

19 DR. BROWN: Let's see if I can remember the three 

20 questions. The first one, the listing of species with the 

21 heavy metals listed for each one, no. I cannot give you 

22 that, simply because I'm certainly happy to provide -- I can 
174

1 give this to Rick, actually, and you can post it to the web 

2 or whatever. I'd be happy to provide the data that I 

3 uncovered in preparation for today, which does list some 

4 species and some studies; but, there certainly is not 

5 extensive information available by metal type. 

6 What there is available, though, in pretty decent 

7 detail, is ash contents for various species. So that it's 

8 kind of a grouping then of all the metals that you might 

9 find in a tree species. And the most common ones that 

10 contribute to ash and trees are calcium, phosphorous, 

11 potassium and magnesium. Those are the four big ones, the 

12 things that we've been talking about today. These 8 things 

13 are traced ash constituents, but, anyway, that gives you an 

14 idea. 

15 Tropical species typically have about double the 

16 amount of ash content than what we see in temperate 

17 deciduous species. So that data is available. Let's see. 

18 The next question was bamboo. I did not look, though. I'm 

19 not aware of data from bamboo. The reason that the tropical

20 species had much higher ash contents is that they tend to 

21 have much more silica, which is taken from the soil in 

22 tropical regions. And so I might expect that similar for 
175

1 bamboo, you might see more silica content as part of the 

2 ash. And I know that other perennial grass is actually like 

3 rice have high silica and silicate content. But, again, I'm 

4 not aware of heavy metal content in bamboo.

5 Was there another question in there, or is that 

6 good? That's good. Okay. Thank you.

7 MS. ADAIR: We are actually a little bit over 

8 time. I didn't want to cut anybody off, but we have one 

9 more.

10 MR. BUTTURINI: I just have a statement to make, 

11 similar to phthalates. The Commission is interested in 

12 which materials would provide the widest scope of relief? 

13 We spent a lot of time talking about wood and a lot of time 

14 talking about plastic resins. If that's true, then you 

15 should go to www.regulations.gov/docket/CPSC-2011-0081, and 

16 submit a comment before April 17th ends. 

17 MS. ADAIR: Thank you so much. Thanks to all the 

18 panelists. That was a really good discussion. 

19 We are going to break and do we want to come back 

20 at 3:15 to stay on schedule. So that's 10 minutes.

21 [Recess.]

22 //
176

1 V. DISCUSSION

2 MR. COHEN: Okay. Good afternoon. My name again 

3 is Neal Cohen. I'm the Small Business Ombudsman at the 

4 Consumer Products Safety Commission. I'm not part of this 

5 team, but they did ask me to moderate this final discussion 

6 session today at 3:15 in the afternoon. Thank you very much 

7 for that distinct honor --

8 [Laughter.]

9 MS. CAMPBELL: Yeah. We appreciate it.

10 MR. COHEN: -- trying to keep everyone awake at 

11 this point. But, no. It's been a very interesting 

12 discussion today, and hopefully scientific and technical 

13 enough that we will be able to bring it back. And with the 

14 submissions to regulations.gov by April 17th be able to come 

15 up with some pathways forward from here. 

16 So today, this final discussion is a bit more 

17 broad in nature. I don't think I would be insulting any of 

18 my panelists by saying they are not necessarily technicians 

19 in the scientific form of the word, but they're very well 

20 versed in the law, the regulations governing this area, and 

21 have their own perspectives on it.

22 Randy and the whole team today have been asking 
177

1 this question, repeatedly, of the various panelists: “how?” 

2 Right? You've made an assertion, but how are you backing 

3 that up with data? “Why?”, “because?”, to get us to the 

4 result. And I think that's very much a question that to the 

5 extent the panel can address, I would so urge you to address 

6 that within the confines of this discussion, which is just 

7 today on possible determinations. Right? 

8 We understand that there are other avenues out 

9 there, potential, so-called third-party testing burden 

10 relief, but that's not sort of what's on the agenda today. 

11 One thing that I think this panel is particularly well12 suited to speak to is not so much of how, why and because, 

13 but which. Which one of these items that are up for 

14 discussion that are in front of the staff for consideration

15 do you in your experience or expertise believe provide a 

16 pathway forward, or believe provide the greatest potential 

17 and scope of relief which is discussed in the Federal 

18 Register notice; and, why do you believe that. 

19 So I'm going to just turn it over. I don't think 

20 anyone has any prepared slides today. The four panelists, 

21 they are Ami Gadhia from Consumers Union; Randall Hertzler 

22 from the Handmade Toy Alliance; Rebecca Mond from the Toy 
178

1 Industry Association; and Rachel Weintraub from the Consumer 

2 Federation of America. And they're going to speak, just in 

3 the order up there, and, I think, be seated or standing, 

4 which ever you prefer. Thank you.

5 MS. GADHIA: Hi. Good afternoon. I'm Ami Gadhia 

6 with Consumers Union. We are the policy and advocacy 

7 Division of Consumer Reports. I thought I'd come up from 

8 behind that podium, since a lot of you probably couldn't 

9 see. So I am coming to this. First of all, I want to thank 

10 the Commission very much for holding this workshop and for 

11 allowing me to speak, and just give some thoughts.

12 My comments will be very much a general frame-up 

13 from the consumer perspective. As Neal mentioned, there was 

14 a lot of technical expertise that was given today, and I 

15 found that very, very interesting and good to know. So just 

16 some thoughts that I would offer generally that we would 

17 urge the Commission to keep in mind as it moves forward on 

18 this particular rulemaking, if that's what it is, and 

19 proposal. 

20 You know, as everybody in this room well knows, 

21 third-party testing was one of the key components of the 

22 CPSIA. Consumers, I think, prior to the CPSIA passing, just 
179

1 sort of assumed that somebody was testing all toys and 

2 children's products for safety and other hazards before they 

3 hit the market. And, sometimes, that was the case, and 

4 sometimes it wasn't. So that expectation is, I think, what 

5 comes to bear, brings us to this point. 

6 There's also the perspective that we believe that 

7 a level playing field on safety keeps manufacturers from 

8 competing on safety and from offering products at a lower 

9 price, because they've not taken the same safety steps that 

10 other, more scrupulous manufacturers have taken. At the 

11 same time, we do recognize that certain third-party test 

12 requirements may impose high, and at times, even a 

13 prohibitive cost on manufacturers who produce only very 

14 small batches of a certain type of product, and whose gross 

15 revenue from the sale of the product is small. 

16 So while we're not opposed to exploring 

17 alternative testing requirements for very small batch 

18 manufacturers, we feel very strongly that every product 

19 intended for children must meet mandatory safety standards 

20 and must be safe. Parents -- this is again coming from the 

21 consumer perspective. Parents buying toys and other 

22 products intended for their children expect them to be safe 
180

1 and to meet applicable standards, whether they're buying the 

2 product at a large box store, at toy fair, small toy fair, 

3 what have you. 

4 We also urge the Commission to ensure that very 

5 small batch manufacturers who receive these exemptions, or 

6 this is less so a comment for, I think, some of the 

7 categorical exemptions that have been discussed today. But 

8 to the extent that there are particular exemptions that are 

9 targeted at very small manufacturers to give them relief 

10 that there's registration with the Commission as to which 

11 companies those are, because if there is a problem, it's 

12 important for the Commission to be able to then follow-up 

13 with those companies and trace the particle back to the 

14 appropriate manufacturer. And, in general, I think what's 

15 going to be very helpful to the Commission and to giving 

16 consumers assurances and piece of mind is knowing that any 

17 exemptions or determinations that are made are empirically 

18 backed-up, that there is solid data to say that this is 

19 something that is clearly not going to pose a hazard, 

20 whether it's not intrinsically in the product or it's not 

21 going to find its way into that product. Consumers need 

22 those assurances, that that kind of determination has been 
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1 independently made based on scientific data, and that's 

2 documented. 

3 I think the Commission is asking all the right 

4 questions to get at all these concerns. Dr. Recht, you 

5 asked a very good question this morning about the Dollar 

6 Store example. In my mind, it was a Dollar Store example. 

7 You were talking about the concerns about products being 

8 made off-spec and ending up in a pool of products that are 

9 maybe sold to low income consumers. That's something that 

10 we're very concerned about, that products don't somehow then 

11 end up in a separate pool and end up being sold at a dollar 

12 store. So that's how I shorthanded it in my brain. 

13 So I think the other concern -- the last point 

14 that I would just make -- is there's been discussion of the 

15 terms "always" and "never" in that kind of a thing. And, 

16 again, a very general concern we'd have is that if you are 

17 across the board making a determination about a particular 

18 product or a particular ingredient, is there no mechanism to 

19 go back and check and make sure that those hazards are no 

20 longer in those products, should processes change, should 

21 ingredients change, raw materials, should the type of resin 

22 in the composite wood change? Do you have to at some point 
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1 come back and revisit that? 

2 So we would strongly urge that there be some sort

3 of mechanism to require both the regulated entities and the 

4 Commission to come back to that analysis. So it's not that 

5 a product is just never checked back up on again and then a 

6 problem emerges down the line. So those are my sort of 

7 general thoughts, and would welcome questions.

8 [Applause.]

9 MR. COHEN: Thanks, and we will take questions at 

10 the end from staff and audience members. Randy?

11 MR. HERTZLER: Thank you, Neal, and I too want to 

12 thank the CPSC for providing this opportunity again for us 

13 to provide input. 

14 The Handmade Toy Alliance is a group of small and 

15 microbusinesses that formed in 2009 after the CPSIA law was 

16 passed in 2008. We really represent the bottom end of the 

17 children's product market, when it comes to revenue figures, 

18 size of the businesses and those sorts of things. But the 

19 Handmade Toy Alliance is made up of 800 small and 

20 microbusinesses. The lion's share, or I believe 95 percent 

21 of the Handmade Toy Alliance members, have fewer than 10 

22 employees. And the majority of them have no employees at 
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1 all, are just sole proprietors. This issue has been 

2 important to the Handmade Toy Alliance, of course, for some 

3 time, because we represent the group of people who find it 

4 the hardest to be able to comply, simply because you do the 

5 math of a third-party test, and you amortize it over 50 or 

6 even 20 items. And you come up with a big number, and that 

7 makes it difficult to sell your product. 

8 So when Public Law 112-28 was passed, there was a 

9 provision for a small batch exemption to provide relief from 

10 third-party testing for these particular -- this group of 

11 people. The small batch exemption has not turned out to be 

12 the primary method of compliance; and, in fact, the small 

13 batch exemption does not exempt the business from 

14 compliance, but simply the third-party test. And I can say 

15 with a high degree of assurance that the members of the 

16 Handmade Toy Alliance are a very conscientious group, and 

17 they want to be able to comply. And a primary method of 

18 compliance has become determinations, because when we 

19 determine that wood does not have lead, I can be a small 

20 batch manufacturer, and then that exempts me from testing my 

21 wood. But the determination means that I comply and that I 

22 know that I comply. And that's important. 
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1 So today we're certainly welcome to accept your 

2 questions and see how this particular process affects the 

3 Handmade Toy Alliance, and I'll certainly welcome your 

4 questions. Thank you.

5 [Applause.]

6 MS. MOND: Hello. My name is Rebecca Mond, and 

7 I'm director of Federal Government Affairs at the Toy 

8 Industry Association. First of all, I want to thank the 

9 CPSC staff, as well as the CPSC leadership in the audience 

10 for taking the time to hold this workshop and engage with 

11 the technical experts on materials determination. This has 

12 been quite the chemistry for a lot of us here.

13 We appreciate the Commission's efforts over the 

14 years to listen to and to integrate many of the regulated 

15 community's comments, as well as the other stakeholders' 

16 comments and suggestions into the testing regulations. We 

17 look forward to continuing to work with the Commission to 

18 further improve the testing and certification requirements 

19 in a manner that effectively ensures compliance without 

20 unduly burdening the regulated community.

21 As the CPSC looks at reducing third-party testing 

22 burdens, we understand that this process requires a 
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1 significant amount of data and requires time. And it 

2 doesn't end with this workshop, nor are comment requests 

3 enough. We need continued dialog with the CPSC staff to 

4 understand what data the agency has, what data does the 

5 agency need, and what data can we provide the agency so that 

6 the CPSC can issue meaningful relief from unnecessary 

7 testing, and not just by acting on these material 

8 determinations, but the other CPSC staff recommendations as 

9 well as some of the recommendations that were brought forth 

10 today.

11 While waiting for CPSC action, many companies, 

12 particularly SMEs, are conducting testing that does not 

13 improve the safety of the product, nor does it give the 

14 company greater assurance that a product complies with the 

15 phthalate or heavy metal standards. I agree with my 

16 panelist's point, here, that testing is a key component of 

17 the CPSIA, provided that the testing advances safety and it 

18 gives a company greater assurance of compliance. 

19 The Toy Industry Association has a high degree of 

20 confidence that the materials discussed today do not and 

21 will not contain the regulated phthalates and heavy metal. 

22 Continuing to require costly testing is not advancing 
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1 safety, but is, instead, an expensive way to prove something 

2 that manufacturers and resin suppliers already know; that 

3 there is a high degree of assurance that these materials 

4 will always comply with CPSIA limits. Thank you. 

5 [Applause.]

6 MS. WEINTRAUB: The last speaker on the last panel 

7 of a day-long workshop like this is a challenge. And it 

8 looks like even the ink filling in my name also was probably 

9 the last one to be printed, because it looks rather tired. 

10 But I am not tired, and I am incredibly glad to be here 

11 today. 

12 I am Rachel Weintraub, legislative director and 

13 senior counsel with Consumer Federation of America. 

14 Consumer Federation of America is a non-profit organization 

15 made up of other non-profit organizations, now are 

16 approximately 250. And we were founded in 1969 to protect 

17 the public interest through research, advocacy and 

18 education.

19 First, I'd like to thank the CPSC Chairman Adler, 

20 Commissioners Robinson and Buerkle. Thank you so much for 

21 your leadership on this issue, and thank you so much to the 

22 CPSC staff. I mean I really think the way that this session 
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1 was organized and structured. And the questions that you 

2 asked throughout the day are exactly the type of questions 

3 that we've been thinking about, and exactly the type of 

4 questions that we'd hope you'd ask to figure out the best 

5 way to move forward on these issues. 

6 As Ami said, the third-party testing provisions of 

7 the CPSIA were very important provisions, and really 

8 represented a paradigm shift for many in the product safety 

9 marketplace. And while CFA and others certainly do not want 

10 companies to have to test things unnecessarily -- and we 

11 support efforts to reduce testing cost, but safety can't be 

12 compromised, and compliance can't be compromised. And I 

13 think that's something that has been reiterated today, 

14 numerous times, by all participants really. And that's a 

15 very important aspect here that safety itself and compliance 

16 itself can't be compromised.

17 So I think, you know, the questions that Randy and 

18 Joel and Kris and Jacqueline -- and especially the way Randy 

19 put it, I think we're all going to remember sort of the why 

20 and the because, I think, are exactly the essence of where 

21 things should be focused so we don't compromise safety and 

22 we don't compromise compliance. So any changes made to 
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1 reduce the testing burdens can't weaken, not only the 

2 testing provisions, but any of the product safety standards, 

3 and can't weaken any public health protections.

4 Just a few things, and some of these were 

5 mentioned today. And I think that after listening today, I 

6 think people generally agree that supplier declarations 

7 alone are not sufficient evidence; that while mechanisms to 

8 ensure that the supply chain is monitored carefully, that 

9 alone is not sufficient evidence to support that a product 

10 does not contain prohibited ingredients. I mean 

11 determinations made ultimately within this framework will 

12 impact both the most scrupulous manufacturers, as well as 

13 the least scrupulous. So all of these decisions need to be 

14 made, knowing that there's a wide variety of manufacturers 

15 of supply chain protections, and that these determinations, 

16 like all rules, impact the entire marketplace and not just 

17 those that are the most rigorous. 

18 While certain chemicals are not naturally 

19 occurring, like phthalates, it doesn't mean that they're not 

20 ubiquitous; and, phthalates are certainly an example of 

21 something that are used in many different products for many 

22 different purposes. So, clear evidence is necessary to 
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1 provide its absence, and I think today we certainly talked a 

2 lot about plastics and hard plastics. But what we didn't 

3 talk about were places where phthalates may be in consumer 

4 products in other contexts, such as fragrances. 

5 And I know that in my home over the years, my 

6 daughters in particular have had dolls, for example, that 

7 smell like particular berries; and, they have plush toys 

8 that when you push them in a certain way, a puff of vanilla 

9 scented air is exuded. And while I'm not a chemist, I do 

10 work with a number of chemists in different capacities, and 

11 I know that there are phthalates in fragrances. So how does 

12 that work in this context, and when there are fragrances in 

13 children's products, for example? 

14 And, not to mention there are certainly children's 

15 cosmetics, children's nail polish, children's perfume and 

16 cosmetics which, while FDA has jurisdiction, it is a 

17 children's product. So these are broader issues to 

18 consider, because the use of phthalates, again, while not in 

19 our environment necessarily naturally, is it in our 

20 environment extensively? And I think that it's also 

21 important, and I think it's clear from this discussion, that 

22 those seeking the determinations bear the burden of proof.
190

1 They bear the responsibility to answer the “why”

2 and to answer the “because.” And I also think that CPSC 

3 should be clear about what evidence is required and is 

4 sufficient to exempt third-party testing from a particular 

5 type of product while preserving compliance with the 

6 provisions of the CPSIA. So I think as we move forward, 

7 answering these questions, it's also very useful and 

8 important for CPSC to be as clear as possible. 

9 Well, thank you all very much, and I'm happy to 

10 take questions as well.

11 [Applause.]

12 MR. COHEN: Thank you, Rachel. So, I guess just 

13 to start of the discussion -- it seems like Joel would like 

14 to say something. Please, go ahead.

15 DR. RECHT: Just real quickly, I just want to make 

16 clear that I didn't say anything about the Dollar Store in 

17 particular. I know Ami didn't mean that I did, but --

18 MS. GADHIA: Yes. My words, not Joel's.

19 DR. RECHT: -- low cost, low quality, but not any 

20 particular venue.

21 MS. GADHIA: Duly noted.

22 MR. COHEN: And, while we're on disclaimers, I 
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1 want to remind you about the one at 9 a.m. this morning. 

2 The views of participants, of course, do not represent those 

3 of CPSC staff. Thanks. 

4 Turning first to sort of representatives from the 

5 business stakeholder community on the panel, I guess I 

6 broached the first question before. Which of the 

7 determinations or categories of determinations that we spoke 

8 about do you see as providing the greatest cost savings to 

9 your particular area and why? And why would they be useful 

10 to you? 

11 MR. HERTZLER: For the members of the Handmade Toy 

12 Alliance, I think that the manufactured woods determination 

13 and the heavy metals -- those two are certainly the most 

14 important. As you might imagine, plastic is not a primary 

15 ingredient in a handmade children's article with the 

16 exception of, perhaps, like buttons or some things like that 

17 that might be used. But, primarily, it's the wood 

18 determinations and the natural material determinations. 

19 It's basically extending the lead determinations to the 

20 heavy metals, as well.

21 MR. COHEN: Thank you. 

22 MS. MOND: I think that based on what we've heard 
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1 from our members, the phthalate testing is very expensive, 

2 and so that has been where we've been focused and where we 

3 believe that determination would provide the most benefit 

4 for industry. And to echo my colleague's points earlier 

5 today that focusing on hard plastics might be the easiest 

6 route; not only from the CPSC resource perspective, but then 

7 also would provide the greatest benefit for the toy 

8 industry.

9 MS. WEINTRAUB: I know you didn't ask me this 

10 question --

11 MR. COHEN: Go ahead.

12 MS. WEINTRAUB: But I'm going to answer, if I may. 

13 I would say I think the CPSC should be guided by where they 

14 have the best evidence, and where they answer the “why” and 

15 the “because.” And where it's chemically -- you know --

16 impossible is a difficult term, but chemically wouldn't be 

17 possible. Or I really think that the decision should be 

18 guided by where the clearest, most robust evidence is in 

19 this phase. 

20 MR. COHEN: There was some discussion in the 

21 earlier panels about the distinction between resins, 

22 pigments, paints. And I wouldn't say it was like it was a 
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1 new idea, but the idea that a determination solely for the 

2 virgin resin itself, untreated, without colorant, would be 

3 of significant utility, certainly, I guess to -- based on 

4 your priorities for the TIA, Rebecca -- the large toy 

5 segment, the large toy manufacturers. 

6 What have you seen so far in your experience in 

7 the component part market today? Because inherent in that 

8 distinction is the idea that the component market would 

9 flourish and be able to distinguish between the resins and 

10 the colorants, et cetera. Have you seen any evidence of 

11 that to-date? Is there nascent activity in that area? 

12 Would this invigorate that?

13 MS. MOND: What we've seen in the component part 

14 market is that the toy industry isn't a significant buyer of 

15 these resins. And so, as a result, the toy industry ends up 

16 taking on a lot of these third-party testing costs. And the 

17 resin suppliers, they know what's in their materials. They 

18 supply the supplier declarations. They do their own in19 house testings, but they aren't willing to incur the third20 party testing costs. So as a result, separate companies who 

21 are buying resin from perhaps the same resin manufacturers 

22 all have to do their own third-party testing. And so there 
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1 would still be a benefit for the toy industry, even if it's 

2 just the raw resin and not going to the colorants, because 

3 they wouldn't have to do that testing on just that resin.

4 MR. COHEN: And have there been any efforts or 

5 movement towards -- I mean how has the component part rule 

6 provided the relief that it was sort of promised that it 

7 might provide to-date? And do you think this could help 

8 that?

9 MS. MOND: It has provided some relief, 

10 definitely. This will certainly provide additional relief.

11 MR. COHEN: Okay. 

12 MS. MANN: This is Hailey Mann from American 

13 Plastic Toys. From a component part testing standpoint that 

14 has provided tremendous relief for us, because if I produce 

15 a toy that has three or four different colors across four or 

16 five different items, then I don't have to test that for 

17 each end unit. For example, we have a hundred colors in our 

18 litany of colorant that we use, and I can test it now in the 

19 liquid form, annually, because it's purchased from one 

20 vendor. So, and it uses the same formulation. So I'm able 

21 to use that component part testing ruling. 

22 I brought orange as an example. So I'm able to 
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1 test this orange, annually, and then I could color every 

2 single different skew number I had orange, and it's covered 

3 by that test result. So for us from the component part 

4 testing standpoint, breaking up the two and testing the raw 

5 resin separately, and the colorant, has given us great 

6 relief from our testing cost.

7 MR. COHEN: And, please feel free to ask more 

8 questions. On these comments regarding would there be a 

9 mechanism to change any of the determination, should things 

10 change in the future, I guess what I heard there on the end 

11 -- and I guess this kind of both goes to both Ami and Randy 

12 Hertzler -- is if hypothetically there was evidence to 

13 provide the Commission with a high degree of assurance to 

14 provide a determination on something like manufactured wood 

15 products. What I think I hear you saying is you would want 

16 the specificity of that analysis to be reflected in the 

17 regulation, such that it's the manufactured wood based on 

18 resins using a urea formaldehyde resin system, or something 

19 to that nature. 

20 MS. GADHIA: Yes, correct, that determination 

21 being a specific determination so that it applies to a 

22 specific set of ingredients, essentially. And it goes back 
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1 to Rachel's point about the evidentiary basis for the 

2 determinations. If that information is available, it should 

3 be -- each determination needs to be specific and backed up 

4 by specific evidence so that there is assurance amongst 

5 consumers that that particular part has been tested, has 

6 been backed up by data, and that determination is made, not 

7 in a blanket way that might raise concerns down the line for 

8 CPSC from a compliance or enforcement perspective. 

9 MR. COHEN: And that would be, obviously, welcomed 

10 by your members. Do you think they would be able to locate 

11 on the vendor market materials delineated in that way? 

12 MR. HERTZLER: Yeah. That's basically where I 

13 would go with this question is if that's the case, it is the 

14 determination is created on an individual basis for certain 

15 combinations of adhesives and that sort of thing. Then that 

16 needs to be able to be identified in the market, obviously, 

17 or it doesn't do us any good. You know. You go to home 

18 depot and you buy three-eighth-inch plywood to make your 

19 wooden puzzles. You need to be able to tell that that 

20 three-inch plywood has the correct adhesive in it so that 

21 you can use it and take advantage of the determination. 

22 MR. KAUFMAN: Hi. Al Kaufman with the Toy 
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1 Industry Association. Actually, it's not a question. I 

2 just had one clarification.

3 Rachel, you'd mentioned phthalates in fragrances. 

4 The phthalates that are in fragrances are not plasticizers. 

5 They're solvents, and so it's overwhelmingly di6 ethylphthalate and di-methylphthalate. So it's sort of 

7 irrelevant to this. They're not regulated under CPSIA. 

8 MS. WEINTRAUB: It would be great, I think, for 

9 there to be evidence provided that supports that. So that 

10 consumers know, consumers would understand. I mean if there 

11 are different phthalates used, then that's important to 

12 know.

13 MR. COHEN: Rachel, in your comments you discussed 

14 sort of CPSC should be very clear as to what evidence is 

15 required, and that the sort of business takeover should bear 

16 the burden of proof in meeting that evidentiary requirement. 

17 The discussion today has used the word "high degree of 

18 assurance" a great deal, which is also the terminology, as 

19 Randy pointed out, that's in 16 C.F.R. 1107. And, as Randy 

20 pointed out, inherent in that is the recognition that 

21 nothing could ever be 100 percent certainty. There's no 

22 certainty, but there is a high degree of assurance. I guess 
198

1 in your comments is that consistent with the sort of 

2 evidence that you'd be looking for from your perspective and 

3 from Ami's perspective?

4 MS. WEINTRAUB: Yeah, I would say yes. I mean I 

5 think, you know, there needs to be the best scientific 

6 evidence provided that supports the underlying statement 

7 that particular ingredients, heavy metals, phthalates, would 

8 not be in other particular materials. I mean certainty I 

9 think is not the goal; but within the framework of the 

10 regulation, I think that all fits together nicely in this. 

11 That's, I think, the way to move forward, but I 

12 think there needs to be clarity in looking over -- there's 

13 actually quite a body of information of different documents 

14 that entities have submitted over time. And there seems to 

15 be some ambiguity about what type of information is 

16 sufficient to make these determinations, and whether 

17 supplier declarations are sufficient. And it just seems 

18 like, you know, I think this is the direction the Commission 

19 is clearly going in after today's meeting. But it seems 

20 like more clarity within that statutory paradigm would be 

21 helpful.

22 MS. GADHIA: I would just add that I think Gibb 
199

1 raised a good point earlier when he was talking to the panel 

2 that Hailey was on about assurances to the Commission that 

3 there is no cherry-picking of data. And I think the same 

4 assurances need to be communicated to consumers as well. 

5 There needs to be a public disclosure, a public explanation, 

6 some transparency to know that there wasn't that kind of 

7 cherry-picking. It's independent, reliable data.

8 MS. WEINTRAUB: And I would just also add that 

9 convening, I think, today, there were great experts who are 

10 here; but also, looking further at other metallurgists, 

11 other chemists who have expertise in these issues who may 

12 not be connected to a particular industry. I know that's 

13 hard in this context, but figuring out who the best, 

14 independent scientists are in the particular field to get 

15 the best evidence so that these determinations are made in a 

16 way that safety and compliance are not compromised. 

17 MS. MOND: One quick point is something I think 

18 was very important to include in the lead determinations was 

19 a provision saying that regardless of any testing 

20 exemptions, the underlying product must comply with the lead 

21 content standard. And, certainly, the toy industry would 

22 expect to have that provision included in any determinations 
200

1 for phthalates or heavy metal standards. So going back to 

2 the example of the fragrance -- regardless of the fragrance 

3 -- the toy must comply with the CPSIA phthalate limits, and 

4 that's also regardless of a testing determination or a 

5 testing exemption that that toy would need to comply with 

6 the phthalate limits. 

7 MR. COHEN: Right. And, Rachel, to your point, I 

8 mean I think CPSC staff today really did try really hard. I 

9 think it was evident today and to try to locate folks who 

10 were sort of outside the usual suspects that people in CPSC 

11 were. Dr. Brown from Penn State -- her expertise was 

12 welcome. And that sort of was kind of the underlying point 

13 to my earlier question to Dr. Brown is what do you do, who 

14 do you do it for, who funds you. Why is no one interested? 

15 What is your source of funding? Because we typically are an 

16 applied research agency. 

17 We have scientists here, but they apply their 

18 technical and scientific expertise to consumer products. 

19 And even though research is part of our mission here and 

20 today is part of reaching that mission, we don't necessarily 

21 -- we're not like NIH or the National Science Foundation. 

22 We don't award grants. And so trying to locate, A, who 
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1 these people are, B, get them to come here on their own 

2 dime, and 3, without really promise of funding, how do we, 

3 collectively, as a stakeholder group -- not just the 

4 business stakeholders, not the consumer stakeholders, not 

5 just the government stakeholders -- how do you find and 

6 bring that set of expertise to answer these "because" 

7 questions and provide that high degree of assurance? And I 

8 think it's an ongoing question, today. I hope you agree it 

9 was a positive first step in that direction. Are there any 

10 questions from the audience? 

11 Sheila, did you have a question?

12 MS. WEINTRAUB: And I would just agree with you. 

13 I mean I think the speakers here -- and maybe I didn't say 

14 it clearly enough. I think they were a great example of 

15 experts, and I found the presentation on wood to be really, 

16 really interesting and insightful. And I think we all 

17 learned a lot about chemistry, as Rebecca mentioned, and 

18 other issues. So I think that the Commission really did 

19 take a very big step and continuing step in doing that 

20 today. 

21 MS. MILLAR: Sheila Millar, Keller & Heckman, 

22 representing the Fashion Jewelry and Accessories Trade 
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1 Association. I wanted to thank the Commissioners and the 

2 staff again for putting together the workshop, and I didn't 

3 want the day to end without asking a process question. 

4 Hopefully you'll maybe address it in the closing comments, 

5 but we're all here for the same reason. We want to assure 

6 compliance, and we want to reduce testing burdens with a 

7 high degree of assurance that products will comply. 

8 So at Regulations dot gov, we'll all be sending in 

9 our comments very soon. But then, I guess, two questions. 

10 What happens after that? I mean what do you expect the 

11 timeframe to be? Do you expect to convene other stakeholder 

12 discussions of this sort? That's question number two. I 

13 mean question number one. And then question number two, 

14 there were some things clearly out of scope for the day, but 

15 there were some points mentioned or alluded to during the 

16 day that could also help reduce the cost of third-party 

17 testing. So is there any expectation that you will be 

18 looking at a second path to evaluate some of those points to 

19 also address cost of testing in that way. Thank you.

20 MR. BUTTURINI: In terms of timeframe, the 

21 operating plan for 2014 for the CPSC states that we'll 

22 conduct additional research. This is part of our additional
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1 research, and that the staff will begin a rulemaking 

2 process, words to that effect. And it says, "begin," which 

3 implies not end by the end of the fiscal year. At least 

4 that's what it means to me, but I can answer your question 

5 explicitly about the timeframe. I don't know.

6 [Laughter.]

7 MR. BUTTURINI: It will take us processing this 

8 data, the first timeframe is two weeks, because we wait two 

9 weeks until the comment period closes and we get all of that 

10 information in. Then we're going to sit down and sort of 

11 try to figure out what it means. So the timeframe was where 

12 I started on it. The operating plan is a certain amount of 

13 staff hours assigned to this sort of thing. The budget 

14 process of CPSC seems continuous in my opinion, but it does 

15 have dates on it. 

16 In terms of your other question about looking at a 

17 second path or other burden reduction possibilities that are 

18 not determinations, the briefing package sent to the 

19 Commission on the request for comments had a long list of 

20 items that could be pursued, basic research looks into one 

21 thing. Determinations was one of these things. Looking at 

22 manufactured wood was another thing, and the Commission 
204

1 chose to look at these particular things right now. They 

2 still have the list, and they can choose it any other time 

3 to staff and fund other activities related to burden 

4 reduction, using items on that list or using something that 

5 we may learn here. You know. This is something that you 

6 want to do now with determination; but, it gave us an idea 

7 about something else, and we can always propose that and see 

8 if the Commission wants to take that up. So doing this 

9 doesn't mean we don't do anything else in that way. 

10 MR. COHEN: Thanks, Randy. And, again, I mean we 

11 do want to encourage the written comments, because, as we 

12 all know, that's really where the rubber meets the road in 

13 these activities. We need to see data. We need to see, 

14 hopefully, peer reviewed literature if it's available, 

15 citations to the literature. If companies have information 

16 that they want to share with us, we'd like to see that 

17 information. 

18 If there's confidential business information, 

19 there may be provisions and ways to get that to us to 

20 protect that, but you can contact one of the staff and we 

21 can speak to that offline. Rick Uhl has a question, but I 

22 also meant to acknowledge Rick who did a lot of the legwork 
205

1 in calling and trying to get experts from outside here 

2 today. So we do appreciate everyone's work on the team. 

3 And, Rick, you did a lot of the groundwork on that.

4 Do you have a question for the panel?

5 MR. HERTZLER: And this is related to the 

6 timeframe issue. The CPSIA law was passed in August of 2008 

7 and the 1500.91 determinations on lead was issued in August 

8 of 2009. So within the span of one year, we had this ruling 

9 and determination on lead. The process that we're in now 

10 started with Public Law 112-28, and I believe the first 

11 request for information was in November of 2011. And staff 

12 came up with their first document, the consideration of 

13 opportunities to reduce testing burdens, something like 

14 that, I think was in 2012. 

15 And we've gone through this iteration of comment 

16 and that sort of thing now for a number of years. So I'm 

17 just curious how the lead determination was able to be 

18 started and finished in the span of less than a year, but 

19 that this process is dragging on for multiple years.

20 [Laughter.]

21 MR. BUTTURINI: Neal owes me one for this.

22 The lead determinations, if you look at the 
206

1 materials in there, they're in the category more of "can't," 

2 and “can't” is much easier than “won't.” Lead can't be a 

3 natural gemstone. Lead can't be in titanium, things like 

4 this. So that was sort of an easier thing to do. That's 

5 one explanation. I wasn't intimately involved with that. 

6 Now we're dealing with man-made chemicals and you can do 

7 anything you want to to manmade chemicals. We're trying to 

8 figure out, rather than “can't,” how do we do this with a 

9 high degree of assurance. 

10 You know. Again, we ring the bell every time that 

11 sort of phrase is done. So we have a tougher technical 

12 challenge to deal with in this and we have a wider range of 

13 things. Lead is one element that is naturally occurring and 

14 it shows up in many products. 

15 When you're getting to phthalates, phthalates is a 

16 man-made chemical done a different way; but, as I found out, 

17 worldwide production of phthalates is greater than worldwide 

18 production of lead, so it actually has the opportunity to 

19 show up in more places than lead shows up in. So part of 

20 this is a technical challenge that we have to deal with.

21 MR. HERTZLER: So it seems like, and I think you 

22 allude to the fact, that there's probably some low-hanging 
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1 fruit here that perhaps could be fast-tracked. For 

2 instance, natural unfinished wood can't have chromium and 

3 antimony, and whatever. I mean maybe that's possible. 

4 Maybe we can say the same thing for bamboo. Maybe we can 

5 say the same thing for cotton fibers. It just seems like 

6 there's a pathway forward on some of these things that could 

7 be accomplished with little effort, that low hanging fruit. 

8 MR. COHEN: Right. And we'll take that comment 

9 sort of in response in the nature of the FR, which is where 

10 is the biggest bang for the buck. And so we appreciate that 

11 comment.

12 Rick, did you have a question?

13 MR. UHL: Rick Uhl again with CPSC, my question 

14 was for Randy. I was just curious about the process that 

15 they use at the Handmade Toy Alliance, if they have, like, 

16 for example, a natural wood product that they're making and 

17 then the paint it. Okay. So if you're exempt on the 

18 natural wood, but then you put the paint on, how do they 

19 handle the paint aspect? Do the paint manufacturers provide 

20 the third-party testing for you, or do they have to go 

21 through that expenditure themselves to do that? Do they co22 op and try to test a single lot, or what's the process? 
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1 Thank you.

2 MR. HERTZLER: Generally, paint would not be a 

3 component, but more typically a surface coating like 

4 beeswax, vegetable dyes, those items that show up in the 

5 determination lists, like beeswax is probably the primary 

6 wood coating that would be used. There would be some use of 

7 the component part rule along with the small batch exemption 

8 and determinations, and sort of this conglomerate of a path 

9 to compliance as well.

10 MR. COHEN: Okay. And with that Jacqueline is 

11 going to come up in a moment. I just want to thank the 

12 panel. I know it was a long day and I appreciate everyone 

13 for everyone's attention and the panel, and all the panels 

14 today, for trying to do their best to stay within the lines 

15 of the Federal Register that we discussed. 

16 There were a couple of off break-outs, but we did 

17 our best to keep everyone on-point and I appreciate 

18 everyone's best efforts to control themselves and cooperate 

19 with us. So thank you to this panel, and I'll turn it back 

20 to Jacqueline.

21 [Applause.]

22 //
209

1 VII. CLOSING REMARKS

2 MS. CAMPBELL: Thank you Neal and thank all of 

3 you. Thank our panelists and the audience, and our audience 

4 out in webcast land. 

5 You know, I know we've said this so many times 

6 that we've gotten some laughs, but we take this very 

7 seriously. Our public comments, we use them to guide us and 

8 inform us. And so we really, really do want you to get your 

9 comments in to us. Again, the deadline for submission is 

10 April 17th. And hopefully now we've given you more 

11 information about some of the things that we're looking for.

12 The idea that data alone doesn't tell us the whole 

13 story or just information about one specific company or one 

14 specific industry doesn't give us the whole story. So we 

15 want you to be mindful of that when you're sending things 

16 in, and if you know what your limitations are, you can tell 

17 us that. Like I only know this information, so the things 

18 that are unknown, acknowledging those things are very 

19 helpful to us too, because then we know where else to look. 

20 So, with that, again, I want to thank all of you 

21 for being here and for participating in this discussion. 

22 And, with that, I think we'll close it. I do want to make 
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1 one note. As I did mention earlier and I think that it was 

2 reiterated a couple of times, we'll be putting the panelists 

3 presentation and the staff presentation on SlideShare. And 

4 for those of you who registered, I will be sending out a 

5 link for both where the webcast will be located, after the 

6 fact, and also where those slides can be found.

7 Again, thank you very much, and I hope you guys 

8 have a great day.

9 [Applause.]

10 [The workshop adjourned at 4:07 p.m.]

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